Raising the bar for chemical safety will spur, not stifle, innovation

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

An emerging chemical industry talking point in TSCA reform is the claim that imposing new requirements on new chemicals will somehow stifle innovation.  The milder manifestation of this perspective emanates from those who oppose requiring a safety determination for new chemicals unless they raise major red flags in an initial review.

But some in the industry go further, arguing that even requiring safety data for new chemicals would put the big chill on development of new chemicals.

I beg to differ with both arguments.  This post will make the opposite case, and will also argue that true innovation embraces rather than shuns safety, and demands the information needed to demonstrate it.

Doesn’t safe mean … uh, safe?

The chemical industry has fought hard for a provision in TSCA reform legislation that would allow new chemicals onto the market without first having to undergo a safety determination.  That approach has crept into the Safe Chemicals Act of 2010:  The new TSCA section 5(a)(1)(B)(ii) would allow a new chemical to enter the market and remain there for an indeterminate length of time, as long as EPA finds that it does not and is not expected to flag any of several criteria.

These criteria include:

  • high-volume production or environmental release;
  • evidence that the chemical does or may possess certain toxicity;
  • evidence that the chemical is both persistent and bioaccumulative; and
  • detection of the chemical in biomonitoring or in food, drinking water, air, soil or house dust.

Some of those criteria may sound reasonably tough, but applying them to new chemicals would be problematic:  A new chemical would not yet be in production and use, so obviously it wouldn’t yet be present in people or the environment. EPA would have to project whether it would later be found there.  I wish I had more confidence in our track record of predicting chemical exposures, but frankly, it’s pretty dismal.

As for toxicity, while the list of types of toxicity in the provision is pretty impressive, the question is whether the minimum data to be required for a new chemical will be sufficient to determine whether it has any of them (more on minimum data requirements in a moment).

A barefaced double standard

Ironically, this provision would do – but in reverse – exactly what the industry has gone apoplectic over in other contexts.  It would decide what to do about a chemical based solely on its hazard or exposure, rather than by assessing its risk.

The chemical industry staunchly opposes ever identifying “bad” chemicals via a solely hazard-based approach.  And it never utters the word “biomonitoring” without hastening to add, usually in the same sentence, that mere detection of a chemical in people says absolutely nothing about its risk.

Yet here the industry is merrily endorsing giving a new chemical a free pass based solely on whether or not it meets certain decidedly non-risk-based criteria.

Last time I recall, the American Chemistry Council’s first principle for modernizing TSCA read as follows:  “Chemicals should be safe for their intended use.”  Just checked again, and yes, it still reads that way.

So why is the industry so willing to let new chemicals slip onto the market without a safety determination?  I smell a double standard.

No data, no problem?

There is one small silver lining to the troubling provision noted above:  It would at least require that the decision as to whether a new chemical meets the red-flag criteria be based on a minimum data set.

The more extreme manifestation of the stifling-of-innovation argument says that even that requirement will cause the ever-churning wheels of new chemicals development to grind to a screeching halt.

Perhaps the most vocal proponent of this viewpoint has been Charlie Auer, former Director of EPA’s Office of Pollution Prevention and Toxics (OPPT), and now a chemical industry consultant.  I heard this argument from Mr. Auer firsthand at a recent conference in DC, which was reported in the April 19, 2010 issue of the Daily Environment Report (page A-11, subscription required).

He points to the draft legislation’s requirement for a minimum data set for new chemicals as evidence of a “strong bias” against new chemicals.  He says that imposing such a requirement would create a disincentive for companies to develop new chemicals, which he argues are safer than older chemicals as a rule.  Finally, he points to experience in Europe, where far fewer new chemicals entered the market over the last few decades than in the U.S., as supporting his case.  Let’s take each of these lines of argument in turn.

Unlevel playing field?

The first argument maintains that there’s an unlevel playing field, because new chemicals would have to provide their minimum data set before they could get on the market, whereas existing chemicals would be given some time to do so.

During this transition, there would indeed be a tilt.  That’s a direct consequence of the fact that TSCA grandfathered in some 62,000 chemicals without requiring any safety testing.  That’s a deep hole, one that can’t be climbed out of overnight.

Auer points to a provision of the Senate bill that would allow makers of existing chemicals up to 14 years to provide their data.  But it’s the chemical industry, not those of us who think new chemicals need safety data, that successfully lobbied for that provision in the Senate bill.

As I noted in a recent post, we want as short a transition as possible, and prefer the House discussion draft’s version of this provision (see section 4(a)(2)).  That version would require data sets on existing chemicals within either 18 months of priority listing or five years of enactment – whichever comes first.

Of course, even if one accepts this line of argument, the status quo is even more tilted against new chemicals.  Under current TSCA, new chemicals are subject to premanufacture notices, while existing chemicals have none.  New chemicals are subject to EPA review, while existing chemicals have none.  EPA can (and occasionally does) require testing of new chemicals through consent orders, while it virtually never requires testing of existing chemicals.

The solution to this problem is to expedite the requirement for minimum data for existing chemicals – not to do away with the requirement for safety data for new chemicals!

Should we presume new chemicals are safer?

Mr. Auer also claims new chemicals are safer as a rule, so we should readily allow them onto the market.  I suppose the rationale is that they will somehow thereby supplant the older chemicals, improving the “average” safety of chemicals on the market over time.

Should we assume new chemicals are a priori safer?  One very recent cautionary example ought to begin to dispel the wisdom of such a presumption: Multi-walled carbon nanotubes (MWCNTs).  These new marvels hold all kinds of promise in applications ranging from stronger composites to superconductive materials to photodetection.  It so happens they are quite toxic:  The are potent inducers of lung inflammation and fibrotic responses, and also seem to have a great deal in common with asbestos fibers, having been shown capable of crossing from the lung into the surrounding tissue and there inducing mesothelioma-like symptoms.

More generally, while the results of EPA’s new chemical reviews are held as top secret information, the European Union reports that its review of new chemicals over the years before REACH found that about 70% of them possessed at least one dangerous property (page 27).

There’s no reason to presume that new chemicals are less safe than existing ones, but the only way we’ll know is to require data sufficient to determine their safety.

And even if one believes a new chemical poses less risk at least initially because it isn’t used widely at the outset, the risk to workers making and handling it is present from day one.  Safety data are essential to ensuring their protection.

More lessons from abroad

Finally, Mr. Auer points to the much lower rate of introduction of new chemicals in Europe than in the U.S. as evidence of the chilling effect of data requirements.

It’s true that only about 4,000 new chemicals entered the market in EU during the same time that nearly 20,000 new chemicals did so in the U.S.  Mr. Auer argues that’s because the EU (even before REACH) had the audacity to require some actual data for new chemicals as a condition for their entering the market.

First, lest you think those tree-hugging Europeans are somehow uniquely anti-new chemical, the U.S. is virtually alone in the developed world in not requiring an up-front minimum data set to inform government’s evaluation of new chemical safety; the EU does, of course, and Canada does, and Japan does.

I’ve noted in an earlier post that TSCA prohibits EPA from requiring a minimum data set for new chemicals.  As a result, 85% of the premanufacturing notices EPA reviews contain no health data, and 95% contain no ecotoxicity data.

But more to the point, the differential rate of new chemical introduction in the U.S. versus the EU and its perceived implications for innovation was in fact a major motivation for the development of REACH; see White Paper, especially pp. 5, 8, 11-12 and 32.

And how did the EU go about leveling the playing field under REACH?  Did it gut the data requirements for new chemicals?  No; it raised the bar for existing chemicals, phasing in requirements over time that will require makers of all chemicals, whether new or existing, to provide data sufficient to demonstrate their safety.

Playing the China card

Unfortunately, there is a rather stale last stanza that’s been added recently to the industry’s song about innovation, a variation on an old theme:  If you over-regulate us, you’ll just push the industry overseas.

In this case, it plays to the broader tune of the China blues:  Innovation will still happen, the lyrics go, it’ll just happen in China.

First, it must be said that this refrain is rather hard to listen to, coming as it does from an industry that is already moving production overseas as fast as it can, and for reasons that have nothing to do with the environment or regulation.

But it’s also tone-deaf:  It ignores the fact that the industry’s own customers, more than anyone else, are demanding more and better information about the chemicals they buy, more, not less, evidence of their safety.

Finally, it ignores the fact that the rest of the world is moving ahead faster than we are to address chemical safety.  That includes even China, which bars domestic use of formaldehyde-laced plywood that we allow to be imported, which has reportedly translated the REACH regulation into half a dozen dialects, and which is modernizing its own laws along the lines of REACH.

Innovation, yes, but to what end?

In my view, one of the most egregious failings of TSCA has been its failure to incentivize innovation toward safer chemicals and products.  Instead, it has perpetuated a chemicals industry that has little incentive either to replace existing chemicals – because they skate along without any scrutiny at all – or to ensure that new chemicals it does introduce are safe (or at least safer than the existing chemicals with which they will compete) – because the review they get is so cursory (data- and time-constrained) that it would catch and be able to stop only the most dangerous substances.

I support provisions in the Safe Chemicals Act of 2010 that would:

  • provide an easier path onto the market for new chemicals the makers of which demonstrate their new chemicals are safer than other chemicals for the uses for which they are intended (see section 32 of the Act); and
  • allow critical or essential use exemptions even for chemicals (whether new or existing) that fail the safety standard, where they fulfill vital purposes for which alternatives do not exist  or can be shown to provide a net health or environmental benefit compared to the alternatives (see section 6(e)(2)).

Both of those provisions encourage the development of innovative new chemicals that are either demonstrably safer or meet an essential need.

Can anyone seriously think that any sort of desirable innovation can happen without ensuring safety?  Safety ought to be at the core of innovation, rather than being seen as an impediment or afterthought.  And in this, regulation can help rather than hurt.

As the EU’s White Paper made clear, stronger regulation through REACH was seen as vital not only to protecting health and the environment, but to shoring up the competitiveness of the EU’s chemical industry (the world’s largest), and putting it on a more sustainable footing.  And smart companies made the connection.  As REACH took effect in 2008, a DuPont spokesperson was quoted saying:

We are implementing REACH as a global program across DuPont, and the impact of REACH will be varied and widespread. We see it as potential to drive market innovation. There are chemicals that may be restricted under REACH, and it'll provide the opportunity for a science company like DuPont to develop replacement products to satisfy market needs. (emphasis added, Greenwire, 6/23/08)

But the chemical industry’s proposal – to allow new chemicals to enter commerce without being demonstrated to be safe, or in the more ominous version, without provision of even basic safety data – would do nothing more than compromise public health in the name of innovation.

That notion of innovation rings hollow and confuses the means with the end.  It is one we are better off without.

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5 Comments

  1. josephguth
    Posted May 10, 2010 at 2:52 pm | Permalink

    Richard has, as usual, raised an issue that is a critical one in all chemicals policy reform efforts.

    One initial point that advocates of chemicals policy reform might not give up on so easily is the chemical industry's claim as to how innovative it actually is. Richard can correct me if I err in my facts here, but I believe this is correct? There are currently about 3,000 or so HPV chemicals, and these constitute well over 99% of the tonnage of chemicals in commerce in the US. About 92% of the HPV chemicals were on the market when TSCA was passed in 1976 and so are on the original inventory of 62,000 chemicals. In other words, only about 250 of today's 3,000 HPV chemicals were newly introduced into commerce after TSCA was passed. (As for lower volume new chemicals, while we know PMN's have been submitted for 20,000 chemicals, we have little idea how many of those are now on the market — but it is undoubtedly far fewer). Can you call an industry "innovative" when today's marketed products are 92% the same as they were 30 years ago? There may be a lot of development of small market specialty chemicals, but for the chemicals that dominate the materials economy, that does not appear to be the case. In fact, that market looks less like an innovative free market responding to market demand than one dominated by products that have become entrenched by operation of a flawed regulatory system.

    As for the effect on innovation that we could expect from imposition of a minimum data set for all chemicals, Richard raises precisely the right point: "innovation to what end?" It may indeed be true that requiring a safety data set for all chemicals would make development of new chemicals more difficult — because a third criterion (in addition to function and price) would be added: safety for human health and the environment. As the CEO of a specialty chemicals manufacturer put it to me once, the issue is not so much the cost of the testing as the fact of having a third criterion for success — fewer candidates will pass three tests than two.

    But what advocates of chemicals policy reform want is innovation of SAFER chemicals, not just innovation of more and more toxic chemicals. The issue is whether regulatory reform is needed to promote innovation of safer chemicals, not just innovation of chemicals. And there can be no doubt that the current system utterly impedes innovation of safer chemicals. As Richard points out, the EU, which actually did require some data for new chemicals, found that 70% of them had some kind of hazard. And since our industry is creating (and providing EPA under TSCA) zero health and safety information for 85% of its new chemicals, there is simply no basis in fact for the claim that new chemicals are likely to be safe — indeed since such information is not being submitted to EPA under the PMN program, industry is intentionally avoiding developing the data that could prove that claim to be true.

    We have to remember that there are many reasons manufacturers of existing products don't want required minimum data sets. They will cost money, they will invite more regulation of uncovered hazards, cause the market to move away from chemicals discovered to be hazards, perhaps invite tort liability, higher insurance costs and higher hazardous waste management costs, and then real problem with innovation: the development of safer substitutes by competitors. While a highly innovative market in safer chemicals would be great for the public and for business as a whole, it would make life difficult for the companies participating in it because you can never stay on top of the innovation curve forever. A regime that fosters innovation represents a threat to only one element of society: entrenched manufacturers of existing products.

    As a patent lawyer, I believe that there is no theory of market operation under which innovation of a particular product attribute is promoted by absence of information about that attribute and by commercial disincentives and regulatory barriers against producing public information about that attribute.

    We don't need more innovation of chemicals that are likely to turn out to be toxic. What we need is innovation of SAFER products, and providing the market with publicly available minimum safety data sets the best and perhaps only way to do that.

  2. Phil
    Posted May 10, 2010 at 7:34 pm | Permalink

    Richard,

    I'd like to hear your thoughts on the information that would be necessary to "demonstrate . . . . new chemicals are safer than other chemicals for the uses for which they are intended (see section 32 of the Act)." I too support section 32 in the SCA, but I'm wondering what information EPA will consider necessary. Thanks in advance for any thoughts you want to share.

  3. Posted May 11, 2010 at 11:55 am | Permalink

    Thanks, Joe and Phil, for your comments.

    Joe, I especially like your point that there's no theory of the market providing that innovation is promoted by absence of information or by disincentives against making more and better information available.

    Phil: As you know, there is a robust debate around the question of how to define "safer." Luckily, the office at EPA, OPPT, that administers TSCA also houses the agency's Green Chemistry and Design for Environment programs, which are logical places for the details of such data need to be worked out.

    Best,
    Richard

  4. Charlie Auer
    Posted May 12, 2010 at 5:31 pm | Permalink

    Dear Richard,

    Regarding your recent posting, I guess every advocate needs a bogeyman and it seems I am it for this issue. I was surprised to see myself characterized as “the most vocal proponent” of a perspective. Wow. To begin, while I have industry clients in my little consulting company, I am speaking for myself and no one else on this issue. To further clarify, I am basing my comments on my lengthy experience at EPA in assessing and managing TSCA chemicals, including being personally involved in evaluating over 10,000 chemicals, many of them new chemicals, including during my time as chair of EPA’s Structure Activity Team (for about 8-10 years as I recall) and continuing thereafter as I moved up to the position of Office Director. Based on this experience I am quite familiar with the kinds of chemicals being introduced into commerce, as well as those already in commerce.

    While at EPA during the early days of TSCA, we used to talk about “old new chemicals” and “new new chemicals.” Most new chemicals are “old new chemicals” which means that they are at best continuous improvement variations on their existing chemical competitors – they might be more selective or efficient in their chemical or product performance, or designed to avoid a particular issue or toxicity, or more energy efficient, or avoid the need for solvents in their applications, or any of a wide variety of often – but not always – minor continuous improvements, including in many cases multiple such improvements in a single new chemical. ”New new chemicals” on the other hand are novel structures which approach a chemistry need in a new way. Relatively few new chemicals are of this type but they can represent important new developments. Carbon nanotubes are an example of such “new new chemicals.”

    I believe it is important to encourage the introduction of both “old” and “new” new chemicals since both can contribute to the realization of a safer and greener chemical economy. Your blog posting broad-brushed my views. Yes, I do believe, based on my experience, that in general “old” new chemicals represent at least a relative improvement (i.e., safer and greener) compared to existing chemicals and to new chemicals from prior years. Which is not to say that new chemicals are without possible issues and concerns or that retrograde new chemicals are never notified: based on figures in the IG’s recent report(http://www.epa.gov/oig/reports/2010/20100217-10-P-0066.pdf) EPA has imposed regulatory controls on 8% of new chemicals and an additional 5% were withdrawn by the notifier often in the face of proposed regulation (I note that this 13% figure is not unlike the 17% that the Canadians identified as needing more scrutiny in their Canadian Environmental Protection Act (CEPA) categorization effort). These actions included, e.g., during the 1980s stopping the introduction of benzidine, beta-naphthylamine, and other (likely) carcinogenic aromatic amine dyes; encouraging the introduction of “P-series” glycol ethers as replacements for “E-series” glycol ethers; working to understand the potential hazards and risks of new acrylate monomers and the “100% solids” acrylate polymer coatings made from them, and once this understanding was obtained, encouraging this important innovation which reduced solvent exposures and energy requirements; and numerous other improvements which may not have occurred without the oversight and encouragement of the new chemicals program.

    Regarding “new” new chemicals, EPA’s approach in every instance was to treat these materials cautiously, imposing regulatory controls while taking steps to ensure an adequate understanding of their potential risks was developed. And this is what EPA has done with CNTs – exposures are tightly controlled and testing is being required strategically to ensure that needed understanding will be developed in a way that spreads the testing burden among the notifiers while allowing for the innovation benefits to be realized within limits (e.g., not all proposed uses are allowed, exposure controls are imposed, etc. – in fact while I was the Office Director all nanoscale new chemicals cases were run by me for the final decision regarding the regulatory and testing requirements and to ensure a high level of policy input into the development of the regulatory approach).

    But I digress, since the major concern in your blog was on my view that imposing an upfront and immediately effective requirement for a minimum data set (MDS) on all new chemicals represented a “strong bias against new chemicals.” As your statistics show, over roughly the same period, there were 4,000 new chemicals introduced in the EU versus over 20,000 in the US. Considering that we notify polymers (~55% of PMNs), and they generally don’t (polymers made with >2% of a new monomer were considered new chemicals in the EU), and that your figures do not include the over 8,800 “low volume” section 5(h)(4) regulatory exemption chemicals that have been approved by EPA through 2006 (http://www.epa.gov/oppt/pubs/oppt101-032008.pdf, see pages 7-12) – 4,000 versus almost 18,000 nonpolymeric new chemicals introduced into commerce is a stark and telling difference. The major difference between the US and the EU’s scheme (other than premanufacture versus premarket notification, respectively) is the requirement for a minimum data set in the EU – so yes, it is clear that an upfront testing requirement while it does provide data at the outset, does have the cost of a significant reduction in the number and likely the variety of new chemicals. This I believe, based on my experience with new chemicals (which says they are generally safer and greener), would negatively affect both access to, and the timing of access to, new chemicals in the US.

    I believe this is an important issue to wrestle with. I further believe it is on the proponents of the “upfront MDS” approach to make some kind of a showing that the US approach has failed in some way. Given the potentially large costs that would be imposed upfront on new chemicals with resultant likely significant drops in innovation through declines in the introduction of new chemicals, what is the evidence that such costs are reasonably justified and necessary? Recognizing that almost 30,000 new chemicals have been introduced into US commerce, if the problem is as serious as you believe surely something more than vague “concerns” must be behind your issue. While I was at EPA, we regularly “checked our work” looking for errors or problems in new chemical decisions (and not just the GPRA reviews the IG’s report talked about) and few problems were found especially when considering potential risks. For example, while EPA may have underestimated or missed a toxicity endpoint, the new information did not change the assessment of risks or the controls imposed (how can this be? Well, for instance, EPA identified a concern for neurotoxicity and liver toxicity was seen in the section 5(e) study, but the overall risks were not different). Nonetheless, EPA continuously ran the new information or test data back into its assessment approaches to strengthen them for the future. This is not to say EPA was perfect but rather that, in my view, it did a responsible and credible job of protecting the American public and environment despite the limitations in the law.

    So what does this mean in the context of the MDS? I believe it provides a reasonable basis for a more flexible and measured approach that helps to continue the kind of new chemical innovation that was realized under TSCA while taking steps to improve the approach and ensure against errors. Despite your characterization of my views, I do not oppose MDS testing on new chemicals, rather I believe that both new and existing chemicals should be treated equivalently and that the timing of the testing requirement on new chemicals is a critical component in the approach. I outlined my thinking in an October 2009 co-authored paper in BNA, a copy of which can be obtained here(http://www.charlieauer.com/home/about-charlie-3/BNAarticle101209.pdf?attredirects=0&d=1), as follows:

    "Congress should find mechanisms to revise TSCA to enhance data submission requirements for new chemicals, and to do this in a way that enhances the capacity for the U.S. to keep innovation and market incentives within the U.S. economy. One way to meet these goals is to make the new chemical requirements generally consistent with the reporting and testing requirements to be imposed on existing chemicals. This can be achieved by:
    • requiring premarket notifications for new chemicals to include basic production, exposure, and use information plus any available hazard and environmental fate information that the company has generated for the substance world-wide, with EPA having the ability to require early development of test data when the Agency identifies any concerns; and
    • requiring the notifier to undertake and complete the same data set that would be required for existing chemicals when the chemical reaches certain production volumes, in accordance with the same time period allowed for an initial report on existing chemicals that EPA establishes (three years might be a workable initial reporting period for submittal of such test data on chemicals newly entering the market).

    Following premarket notification and meeting such an initial data submission requirement, a “formerly-new” chemical would need to meet any regular periodic testing and reporting requirements that are established for existing chemicals."

    Thus I would approach the MDS differently and not apply a blunt upfront requirement for the MDS as the current legislative drafts do. As is evident, it is not accurate to claim that I am opposed to minimum testing on new chemicals, rather my approach is more nuanced and focused on using the statute to encourage the introduction of such chemicals while making it clear that they would need to meet the same test data standards as those on existing chemicals and with a time-frame generally similar to that applied to existing chemicals. While my approach would doubtless also have an impact on the introduction of new chemicals, I believe it is more measured and balanced and would avoid the blunt impact of an upfront MDS while ensuring that this gap in understanding was filled within a few years time.

    You blog posting raised a number of other issues which I may come back to in the future. ‘Til then

    Regards,

    Charlie Auer
    Charles Auer & Associates, LLC

  5. Posted May 17, 2010 at 9:36 am | Permalink

    Charlie:

    Thanks for your comments. Sorry that you feel the bogeyman – that was not my intent. I think we have an honest disagreement. I strongly believe that the best time, from all perspectives, to ensure chemicals are as safe as possible is at the outset, before they are ensconced in commerce such that, if a problem develops, having to scale back their production and use is politically, logistically and socially much more difficult.

    People who learn that chemicals are allowed on the market today without testing (85% of premanufacture notices have no health data) and rigorous safety assessments are understandably shocked. They get it that the gate should be placed at the entrance.

    As you well know, half or more of the new chemicals EPA must review each year never go on to enter commerce, indicating a less-than-serious intent by their makers. That places a substantial burden on EPA and the public instead of on them. Placing a somewhat higher hurdle at the outset might help address this problem as well.

    For too long, our policies have failed to require that safety be fully integrated into the process of new chemical development and commercialization, alongside traditional factors such as performance, cost and customer/consumer acceptance. The latter factors are routinely incorporated and optimized against from the outset. Why not safety?

    Considering safety during chemical R&D, whether through incentives, mandates or both, is the fundamental premise behind the major paradigm shifts of the last two decades, embodied in pollution prevention, green chemistry and design for environment – essential parts of EPA’s toxics office that have for too long been its poor stepchildren.

    I have always maintained that, given the constraints placed on it by TSCA (a 90-day review period, inability to require up-front safety data, an onerous administrative and legal burden to meet to require testing, etc.), EPA’s New Chemicals Program admirably embodied the adage “necessity is the mother of invention.” Because it had to, EPA has found ways to conduct expedited screening reviews, to prod companies into conducting testing, to negotiate rather than regulate the imposition of risk management controls.

    But that does not mean it is the best way of assessing new chemicals. TSCA reform at last provides us with an opportunity to do better.

    Your comment pointed again to the differential rate of introduction of new chemicals under the old EU scheme vs. TSCA, attributed to lesser requirements imposed on existing relative to new chemicals. Agreed. But you did not address my point that the solution the EU chose was to raise the floor for existing chemicals, not to lower it for new chemicals.

    You also don’t acknowledge that, under the provisions of the House discussion draft, the main problem you pose — new chemicals having to meet data requirements sooner than existing chemicals — is a highly transitory case, a consequence of the practical inability to impose data requirements on all existing chemicals overnight. Here’s the timing:
    • 1 year after enactment EPA promulgates the minimum data set.
    • 18 months after enactment, EPA publishes the priority list of not less than 300 existing chemicals.
    • 18 months after that, those priority existing chemicals must submit their MDSs.
    • All existing chemicals must submit their MDSs within 5 years of enactment.
    • New chemicals must submit their MDSs at the time they are first notified to EPA.
    – I’ll be the first to say there is an unaddressed issue here, namely the need to provide a transition for new chemicals notified during and shortly after the period that EPA is developing the MDS, which allows makers of new chemicals sufficient time to develop it. To that end, I have proposed that EPA impose more limited interim data requirements on new chemicals during this transition, and require the full MDS within 18 months after it promulgates the MDS.
    – This would mean that during the transition, new chemicals would have up to 30 months after enactment to get their MDSs in. That would the same time period as for a priority existing chemical. Other existing chemicals would have up to 60 months from enactment.

    So, yes, for a brief period of 30 months, new chemicals would have to provide a MDS sooner than most existing chemicals. That differential would steadily shrink over that period to zero.

    Finally, in another respect there may be less difference in our positions than appears at first blush. The House draft allows EPA to establish MDSs that encompass “varied or tiered testing” for different categories of chemicals. I don’t see why some new chemicals, especially those with limited production, use or exposure, shouldn’t be able to be accommodated under this provision.

    With the House discussion draft already defining new uses under section 5 to include expanded production as well as uses (potentially triggering new determinations), and with EPA’s authority to require more data either through establishment of tiered MDSs or using its omnibus authority, perhaps you’re reading the draft much more rigidly than am I.

    Regards,
    Richard

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