Over the last few months, I was heartened to hear a number of industry stakeholders in the debate over TSCA reform embrace the idea of designating in TSCA reform legislation a "jump-start" or "quick-start" list of chemicals of high concern or priority.  The idea was to allow EPA to hit the ground running, by having an agreed-to list of chemicals on which it could immediately initiate action.  Well, it now appears many in industry actually have something far slower and far more cumbersome in mind.

The Subcommittee on Commerce, Trade and Consumer Protection of the U.S House of Representatives' Energy and Commerce Committee held a hearing yesterday on the question of "prioritization":  How a new law could best spur prompt identification of and action on the chemicals of highest concern.  Mr. Bill Greggs testified on behalf of three trade associations prominent in the debate over TSCA reform:  The Consumer Specialty Products Association, the Soap and Detergent Association, and the Grocery Manufacturers of America.

In Mr. Greggs' testimony and answers to questions from subcommittee members, what industry has in mind when it talks about a quick start became much clearer:

• There would be no list of chemicals in the bill.  Nor would there even be a process laid out by which EPA would identify chemicals of highest concern for the purpose of promptly taking action to reduce exposure to them.
• Instead, the bill would merely contain some potential hazard and exposure triggers for EPA to consider. 
• The legislation would then impose a risk-finding requirement on EPA (sound familiar?), by restricting any further effort to only those chemicals that are found – on the basis of existing information, however incomplete – to pose BOTH the highest hazard and the highest exposure.
• Once the legislation passed, EPA would first have to develop specific high-hazard and high-exposure criteria, and then apply the criteria through a review of all chemicals it knows to be in commerce and for which such hazard and exposure data exist.
• Then EPA would have to provide industry with a robust process by which industry could – and surely would – challenge each and every designation of such a chemical by EPA.
• Assuming any chemical made it through that process, such highest-of the-high-priority chemicals would then merely enter a further limbo:  a review and risk assessment process as a prelude to a "safe use" determination by EPA.

Hardly the quick start I had hoped for. 

If the last decade of voluntary programs and ChAMP has taught us anything, it's that it's time to move beyond the endless cycle of having one round of assessment to identify chemicals of highest concern lead to nothing more than a further round of assessment.

The re-energized new leadership at EPA recently took upon itself to identify an initial handful of bad-actor chemicals, for which it is developing action plans to reduce the harm those chemicals are causing.  EPA didn't ask for industry's blessing before listing those chemicals.  Can you imagine what would have transpired had it done so?

Nor should EPA have to provide an opportunity for industry to challenge such listing decisions:  Under Greggs' scheme, any listing of chemicals is pre-regulatory –  indeed, it's arguably pre-pre-regulatory or even pre-pre-pre-regulatory.  The notion that EPA's mere identification of a chemical through such a process should be eligible for challenge by the very companies that make or use the chemical is preposterous – not to mention a recipe for endless delay and fights.

And hey:  Wasn't avoiding all that the motivation behind having a quick-start list in the first place?

Lest you think I'm reading too much into a 5-minute statement at a hearing, I'll point you to a detailed proposal these same three trade associations (joined by a dozen others) gave to California earlier this year, as a "model" for regulations under the state's Green Chemistry Initiative.  By my count, that proposal would provide no fewer than six – 6 – opportunities for industry input into and challenge of the state agency's process for designating and prioritizing a chemical of concern.

Talk about greedy:  In addition to requiring formal notice and comment on any proposed listing of chemicals, that proposal would require another round of notice and comment on the "final" list.  And it would repeat that dual-intervention opportunity at each of several steps in a process that would precede any regulatory action to restrict the use of the chemical.

That makes the federal rulemaking process under the Administrative Procedures Act look like a cakewalk in comparison, even after factoring in the interventions by the Office of Management and Budget called for under Executive Orders and such.

A prominent refrain in the industry's new TSCA hymn book has been to say that EPA needs more authority.  I, for one, would like to hear that tune sung more than just in Sunday choir and have it enter the actual work week.

Today, EPA Administrator Lisa Jackson unveiled the Obama Administration's "Essential Principles for Reform of Chemicals Management Legislation."  The principles' significance lies not so much in the words they contain, but rather in what they symbolize:  A clear confirmation that this Administration understands that the Toxic Substances Control Act (TSCA) needs fundamental reform and that it is ready and willing to engage in making it happen.

There's no shortage of principles and platforms for TSCA reform, of course.  See my earlier post comparing and contrasting the platform of the Safer Chemicals, Healthy Families coalition – of which EDF is a member – with the American Chemistry Council (ACC) "principles for modernizing TSCA.”

So what does EPA's entrance into the fray mean?   It is a real sea change to have the very agency charged with implementing TSCA be willing to say the law isn't working, that it doesn't provide EPA with the tools it need to do its job.

Who would know better than EPA?

For the first time EPA is publicly affirming it needs substantially greater authority if it is to protect human health and the environment from dangerous chemicals.  And the preamble to the principles makes clear that EPA stands ready to engage, to work for TSCA reform, and that such reform should happen "quickly."  That's great news, and a major reversal from the last EPA's view that TSCA was working just fine as is.

It's also noteworthy that Ms. Jackson identified the principles as those of the Obama Administration, not just EPA.  That reflects the fact that they went through a thorough interagency review process – and it also means they have the backing of the White House.

I'm not going to attempt to dissect or parse in detail the new Administration principles here.  I'll only say they encompass most of the elements EDF and others have for years been arguing are essential to TSCA reform, including:

• a requirement that industry develop and provide to EPA the data needed to determine whether chemicals – both new and existing – are safe;
• far greater and easier authority for EPA to require additional testing of chemicals;
• assessment of chemical safety against a health-based standard, rather than the cost-benefit "unreasonable risk" standard that has been the downfall of the current TSCA;
• an obligation to address the higher risks to sensitive subpopulations, including children, workers and communities suffering disproportionate impacts from chemicals;
• authority to reassess safety when a chemical's production or use changes or new information emerges;
• authority to require use and exposure information from downstream users as well as chemical makers;
• narrowing the ability of industry to claim its submissions as confidential business information, and requiring an up-front justification for any such claims; and
• the need for a dedicated source of funding to support EPA's implementation of TSCA, derived from chemical manufacturers.

Not a bad start for the new leadership at EPA.

This new post serves as a response to Charlie Auer's most recent comment responding to our critique of ChAMP.  (To see the whole exchange, start here, then go here, here and here.)  So far, this exchange has focused mainly on our disagreement over whether or not EPA is somehow required to do risk assessments under ChAMP.  At some point, I hope Charlie and others will engage on the substance of our critique – the serious concerns we've raised about the quality and validity of the ChAMP assessments.
 

Risk-based at all costs?

In Charlie's latest comment, his main interest seems to be to lock in EPA's current approach under ChAMP.  He steadfastly maintains that EPA now has no choice but to turn out risk decisions for HPV chemicals under ChAMP, given its 2007 commitment under the Security and Prosperity Partnership (SPP) signed by President Bush. 

For all the reasons I've stated earlier, I strongly dispute that conclusion.  Indeed, it is striking how the chemical section of the SPP agreement – including the very language Charlie cites ("the three countries [are] to enhance appropriate coordination in areas including testing, research, information gathering, assessment, and risk management actions") – seems to go out of its way to avoid linking the words "risk" and "assessment."  That term never appears.

I don't dispute, as Charlie says, that "US and Canadian [regulatory] actions are risk-based."  Indeed, EDF supports the view that, in most cases, chemical regulatory actions ought to be risk-based, or certainly ought to take into account both hazard and exposure.

Now, if ChAMP were actually proposing any actions to mitigate risk, e.g., to restrict production or use of any HPV chemicals through regulation, Charlie's argument might be germane.  But as we've noted, ChAMP's not doing that, even for the few chemicals it has designated to be of high risk and high priority.

So the fact that EPA will only consider regulating a chemical based on risk in no way requires that EPA must do risk assessments under ChAMP – regardless of whether the data available to the agency are sufficient to support such assessments. 

Indeed, the SPP agreement was signed well before the use and exposure information EPA has collected under the Inventory Update Rule (IUR) were made public and its major deficiencies were realized.  I disagree with Charlie that the mere fact that EPA collected such data compels it to use them regardless of their adequacy.

As we noted in our last two posts on ChAMP, in cases where hazard concerns warrant action, there are lots of steps the agency could be taking to manage or reduce potential risks – without having to wait for the emergence of use and exposure data of sufficient quality to carry out a risk assessment.  EPA itself has taken such actions occasionally, for example in launching the 2010/2015 PFOA Stewardship Program.

Sacrificing the public's chemical right-to-know on the altar of risk

Add to this the fact that EPA's insistence on pursuing the "rush to risk" under ChAMP is delaying the public's right-to-know about the hazards of HPV chemicals, and I have to strongly question the wisdom of EPA's devoting most of its limited chemical program resources to doggedly pursuing this course.

I also am disturbed by Charlie's conclusion that his and EPA's interpretation of the SPP commitments "are superior to and overtake informal EPA commitments made to pursue the NPPTAC recommendation."   Recall that NPPTAC recommended, and EPA agreed, that the agency issue hazard characterizations and identify remaining data gaps for some 1,200 HPV chemicals by the end of 2009, which it's nowhere closing to meeting.

What NPPTAC called for did not come out of thin air:  It reflected the core purpose of the HPV Challenge, which was in turn the cornerstone of EPA's much-touted chemical right-to-know initiative:  It would be tragic indeed if EPA chooses to negate its public right-to-know commitments by saying they've been trumped by a political decision made by the last administration.

Under ChAMP, the minimum data set has become wholly optional

Charlie cites OECD guidance calling for integrating exposure considerations into assessment activities.  We have no quarrel with that, as long as the exposure information is sufficient; but as our examples amply demonstrate, that is not the case with the IUR data.

Nor does consideration of exposure in any way obviate the need for a complete Screening Information Data Set (SIDS).  International experts convened by the OECD, including from the U.S., devised the SIDS to be the minimum amount of hazard data needed on which to base a screening-level assessment.  EPA itself has repeatedly acknowledged this fact; see, for example, p. 15 of this EPA report on the HPV Challenge.  Outside of some very limited derogations (e.g., for closed-system intermediates) from certain endpoints, full SIDS data sets are to be provided – wholly independent of exposure considerations.

The need for such complete screening data sets is all the more critical given that EPA is intent on making low-priority designations that preclude, for the foreseeable future, any further data development.  Yet under ChAMP, EPA is routinely making such designations for chemicals that lack the basic SIDS data set.

Acknowledging the limitations

It's very helpful and refreshing that Charlie, as former head of EPA's toxics office, acknowledges that EPA faces high hurdles in trying to mandate testing through issuing TSCA test rules.  That's what many of us have been saying for years, and it's among the strongest arguments for why we so badly need fundamental reform of TSCA.

But even without issuing test rules, EPA could help this situation enormously by forthrightly and transparently identifying and acknowledging the significant gaps and deficiencies in the quality of data remaining for HPV chemicals sponsored under the Challenge.  Instead, Charlie and EPA are papering over the problems through their rhetorical sleight-of-hand of substituting "data gap" with "data need."

Interestingly, Charlie argues that instead of our pressing EPA to pursue test rules, we should just wait for the European Union's REACH Regulation to provide most of the data we need.  As tempting as that sounds, some notes of caution are warranted.  First, for all tests involving laboratory animals, REACH requires only that test proposals, not test results, be submitted at the time of registration.  So even in the best of circumstances, much of the data we need for HPV chemicals likely won't be available for some time after the registration deadline of December 2010.  Second, as I've discussed at length elsewhere, it remains to be seen just how much testing will be required under REACH.

I also appreciate that Charlie has acknowledged the need for major changes in EPA's Inventory Update Rule, given the hugely disappointing results of the latest data collection effort.  I agree with many of his thoughtful proposals for needed fixes.  I'd add another:  Require annual reporting of production and use data.  The current reporting requirement is limited to only a single year once every five years – yielding a highly distorted view of actual chemical production (for more on this, see p. 38 of this paper).

But given the rate at which ChAMP is churning out risk decisions using the current IUR data, I must heartily disagree with his notion that we should set aside concerns about those data and only focus on making improvements for the next IUR collection cycle.  That collection won't even begin until 2011, and if this last round is any guide, data won't be released until 2013 or 2014.  On EPA's current trajectory, ChAMP will have already cranked through all of the HPV chemicals by then.

Bottom line:  ChAMP embodies a blatant double standard

Charlie's responses to date (and the lack of any response from current EPA staff) suggest an unwillingness to engage on the substance of our critique of EPA's ChAMP assessments – its systematic reliance on incomplete and/or poor-quality data, a problem further compounded not only by EPA's refusal to reject such data and identify them as gaps, but its use of such flawed data as a basis to claim no or low toxicity, and thence to draw unwarranted low-risk conclusions about hundreds of HPV chemicals.

All of this brings me to the crux of the problem:  Under ChAMP, EPA appears more than willing to rely on limited hazard, use and exposure data to effectively exonerate scores of chemicals, by relegating them to the low-priority dustbin.  Yet in the few cases where EPA has had to conclude, using the same quality of data, that a chemical poses a high level of concern, no action to control such chemicals is even proposed.

Charlie's characterization of such high-priority chemicals as being only "putative positives" is quite telling.  It's a clear illustration of just how high a bar EPA has set to initiate action to reduce use of or exposure to (or even mandate testing of) a problematic chemical – in contrast to the remarkably low bar it must clear to dismiss a chemical altogether.

That's a double standard I just can't abide.

As I noted in our first post on ChAMP, after getting off to a strong start in 2007, EPA's abrupt decision in 2008 to steer ChAMP in the direction of cranking out hasty risk decisions was entirely its own.  Can ChAMP be put back on track? 

Neither EPA's own advisory committee – which had many members from the chemical industry as well as a few environmental NGOs – nor the commitment made by the U.S. under the North American Security and Prosperity Partnership (SPP) agreement signed with Canada and Mexico in August 2007, called for such risk assessments or risk-based prioritizations. 

The commitment EPA made under the SPP agreement was "to assess and initiate needed action on the over 9,000 existing chemicals produced above 25,000 lbs/yr in the United States."  There was no mention of risk assessment anywhere in the agreement.  Indeed, at that time, EPA had already begun to publish hazard characterizations, which, as assessments of the hazards of high production volume (HPV) chemicals – fully meet the terms of its SPP commitment.

EPA's focus on developing HPV chemical hazard characterizations was also precisely what it had committed to do when it adopted, in November 2005, the recommendations of its own National Pollution Prevention & Toxics Advisory Committee (NPPTAC).  Specifically, it agreed to complete and make public such hazard characterizations on all HPV chemicals for which it had received final data sets from the HPV Challenge – some 1,200 chemicals – within four years.

How close is EPA to meeting that commitment, with only six months to go?  As of today, EPA has issued only about 130 hazard characterizations covering about 315 HPV chemicals (many of the chemicals are in categories).

So EPA's rush to risk is not only resulting in flawed risk decisions that are prematurely exonerating hundreds of chemicals, as described in our earlier posts.  It is also causing EPA to renege on its promise to characterize the hazards of all sponsored HPV chemicals in a timely manner – and to clearly identify gaps in the quality and completeness of the data received under its voluntary program.

In short, EPA is compromising the public's right to know about the hazards of the most widely used chemicals in U.S. commerce.  That's quite ironic when you consider EPA bills the HPV Challenge and ChAMP as cornerstones of its Chemical Right to Know Initiative.

What should EPA be doing under ChAMP?

EDF is the only environmental NGO that has been willing to engage with EPA, first on the HPV Challenge and more recently on ChAMP.  We served on advisory panels, participated in public meetings, carefully peer-reviewed draft assessments, filed comments and met with EPA staff repeatedly. 

Even now, we are the only voice in our community arguing that the HPV data and ChAMP could provide value if it got back on track.

We have pointed out that many of the shortcomings of the HPV and ChAMP initiatives are due to EPA's limited authority under the Toxic Substances Control Act (TSCA), and we are actively working toward fundamental reform of TSCA to give EPA the tools it needs to do a better job.

But we also believe that in the interim, and despite EPA's constraints under TSCA, EPA can and should be doing a more credible and valuable job under ChAMP. 

EPA should:

• Return the focus of ChAMP to completing high-quality hazard characterizations for HPV chemicals, rather than rushing to issue highly suspect risk characterizations based on flawed assumptions and poor-quality use and exposure information.
• For each chemical assessed, clearly identify and communicate to the public all gaps or quality concerns in available data.
• Stop assigning low-priority rankings to chemicals, especially those with data gaps in the most basic, minimum set of screening-level hazard data. As we said before, it's one thing for EPA to identify as high-hazard those chemicals where, despite the data gaps, available data demonstrate high toxicity. It's quite another for EPA to effectively exonerate chemicals as low-hazard or low-priority when not even a bare-minimum data set is available for them.
• Adopt a health-protective approach to hazard screening: Where data are uncertain, of questionable quality or equivocal, assume a hazard exists until and unless a chemical's manufacturer provides the data to show otherwise.
• Issue test rules to require that gaps in submitted data sets be filled.
• Significantly accelerate issuance of test rules for all of the unsponsored HPV Challenge chemicals, and for the hundreds of newly emerged HPV chemicals that have never been sponsored.
• For the ~4,000 medium-production volume (MPV) chemicals – which are also covered by the SPP commitment, and for which even less data are available than for HPV chemicals – focus on identifying and acting to address data needs to support more robust hazard assessments, rather than pursuing its current approach of using scientifically unsupportable extrapolations of data among loosely defined "clusters" of such chemicals.

For chemicals for which significant hazards are identified, here are some of the good recommendations that NPPTAC offered as steps EPA could take even under its current TSCA authorities, which EPA has yet to act upon (under each, I've added a few elaborations and additional thoughts of my own in brackets):

• Gather additional information on uses (e.g., by use function, category, release potential, or benefit) and exposure (to humans and/or the environment).
  • [Listing such substances on the Toxics Release Inventory would be a great way to get direct exposure data. Efforts to get better use and exposure information - well beyond the data EPA got from manufacturers under its Inventory Update Rule (IUR) - could extend to downstream users of chemicals. Information on functional use would help in identifying safer substitutes within the same functional class.]
• Gather additional information on hazards to support a more in-depth characterization.
  • [Our reviews of EPA's risk decisions have identified many cases where available studies raise more questions than they answer, or identify additional concerns. EPA should require further testing in such cases.]
• Identify existing risk management programs and practices. Evaluate existing Federal and State regulatory controls (e.g., occupational exposure limits).
  • [Instead, in many cases EPA merely asserts the existence or effectiveness of such practices, and seems particularly averse to even suggesting that some risk management might be needed.]
• Provide information referrals or recommendations for actions to other EPA program offices or other Federal or State agencies.
  • [These could include referrals to OSHA requesting action on chemicals posing high worker hazards, proposing that the Centers for Disease Control or the U.S. Geological Survey add such chemicals to their biomonitoring and surface water monitoring programs, referring chemicals to its own Design for Environment (DfE) program to assess the availability and safety of available alternatives to hazardous chemicals, and referring such chemicals to the Food and Drug Administration where they have uses or are in consumer goods that fall under its jurisdiction.]

That's more than enough to keep the EPA toxics office busy for the foreseeable future.

[The first post in this series can be found here.] 

Some in the chemical industry point to EPA's New Chemicals Program as a robust program, one that could serve as a model for reform of the Toxic Substances Control Act (TSCA).  Most recently, the National Petrochemical & Refiners Association (NPRA) did so in its testimony at a recent House of Representatives subcommittee's TSCA oversight hearing.  So just how robust is EPA's program on new chemicals? 

When it was enacted in 1976, TSCA drew a clear line between "new" and "existing" chemicals.  Existing chemicals – those in commerce in the mid-late 1970s when the TSCA Inventory was established – did not have to be reviewed by EPA in order to remain on the market.  In contrast, new chemicals – defined as those not on the TSCA Inventory – cannot enter commerce without such an EPA review.  Once that review is completed and manufacture commences, a new chemical is placed on the Inventory and essentially becomes an existing chemical. 

Of the roughly 84,000 chemicals now listed on the Inventory, 62,000 were in commerce when TSCA was enacted, and about 22,000 new chemicals have since entered commerce.  EPA reviews about 1,500 new chemicals every year, about half of which go on to enter commerce and be listed on the Inventory.

So right off the bat, it's important to recognize that the great majority of chemicals in commerce are not and will not be addressed by EPA's New Chemicals Program (NCP).  Rather, advocates for NCP as a model chemicals policy argue that TSCA reform could consist of simply applying the program's basic approach and review processes to chemicals already on the market.

Unfortunately, while it makes a lot of sense to mandate that new chemicals be reviewed before their commercialization, Congress dealt EPA an exceedingly poor hand to use in conducting such assessments.  Below I'll explore the following limitations, each of which illustrate why the NCP is not a good model for TSCA reform:

• No data, no problem: No up-front testing requirement or minimum data set applies to new chemicals.
• Guessing game: EPA is forced to heavily rely on limited models and methods to predict the toxicity or behavior of a new chemical.
• Catch-22: While EPA can require testing of a new chemical on a case-by-case basis, it must first show the chemical may pose a risk – not an easy task without any data in the first place!
• One bite at the apple: EPA typically gets only a single opportunity to review a new chemical.
• Crystal-ball gazing: EPA has to try to anticipate a new chemical's for-all-time future production and use.
• Black box: New chemical reviews lack transparency.
• Anti-precaution: In deciding whether to require testing or controls for a new chemical, EPA equates lack of evidence of harm with evidence of no harm.

The bottom line is that – precisely because it suffers from TSCA's major structural flaws – the NCP falls far short of serving as a model for the statute's reform.

No data, no problem:  No up-front testing requirement or minimum data set applies to new chemicals.

TSCA requires any company planning to produce or import a new chemical to notify EPA at least 90 days before commencing manufacture.  The notification typically takes the form of a Premanufacture Notification (PMN), unless the company seeks any of several exemptions EPA provides (for more on the available exemptions, see here).

PMNs must include basic information on anticipated use, production volume, exposure and release – to the extent such information is known or reasonably foreseeable by the submitter at the premanufacture stage. 

However, TSCA does not require companies to submit a minimum base set of data on a chemical's toxicity or ecotoxicity or its environmental fate and behavior.  This oddity of TSCA stands in contrast to the policies of virtually every other developed country in the world.  Although EPA encourages such data to be included in the PMN, the great majority of PMNs do not:  67% of PMNs contain no test data, and 85% of PMNs contain no health data; and more than 95% of PMNs contain no ecotoxicity data. 

TSCA actually precludes EPA from requiring up-front development and submission of a minimum set of data on a new chemical's hazards, by limiting the data required to be submitted in a PMN to that which is either already "in the possession and control" or is already known to, or "reasonably ascertainable" by, the notifier.  See TSCA Section 5(d).

Despite this lack of even basic data on a chemical's hazards, TSCA typically requires that EPA complete its review of a new chemical within 90 days and decide whether a chemical needs more data or any restrictions placed on its manufacture or use; if EPA fails to act, manufacture can commence. 

What's an agency to do?

Guessing game:  EPA is forced to heavily rely on limited models and methods to predict the toxicity or behavior of a new chemical.

To make the best of the bum hand it was dealt, over the last several decades, EPA's New Chemicals Program has pioneered the development of – and relies heavily on the use of – predictive methods and models, most notably structure-activity relationships (SARs).  SARs attempt to predict the behavior or toxicity of an untested chemical based on how similar its chemical structure is to those of other tested chemicals.  SARs include both mathematical models and algorithms that yield quantitative estimates, and more qualitative approaches that group chemicals into categories based on structural similarities and "read across" from tested to untested chemicals within the category.

EPA's efforts to develop ways to predict the hazards of new chemicals in the face of the constraints under which it must operate under TSCA have been admirable.  But they hardly represent an ideal or model approach to data development. 

Among other things, SARs themselves have severe limitations:

• SARs are only available and reasonably robust for a subset of even basic hazard endpoints of concern, and are best for predicting properties like persistence and bioaccumulation potential. In particular, with the notable exception of genotoxic carcinogenicity, validated SARs are lacking for most human health-relevant endpoints, especially for chronic concerns such as reproductive and developmental effects.
  A good illustration of this limitation is the fact that EPA's otherwise-useful online SAR tool, the PBT Profiler, includes only one toxicity endpoint – a value for chronic toxicity to fish.
• SARs don't work or haven't been developed for many major classes of chemicals, including highly fluorinated compounds, inorganic chemicals, salts of organic chemicals, even moderately reactive chemicals, surfactants, and any multi-component process stream or mixture.
• Even for covered endpoints and chemicals, SARs can provide estimates that differ dramatically from measured data. For example, EPA has found that its SARs predicted that the acute aquatic toxicity of dichloroacetyl chloride would be three orders of magnitude lower than found when directly measured in aquatic organisms.

Catch-22:  While EPA can require testing of a new chemical on a case-by-case basis, it must first show the chemical may pose a risk – not an easy task without any data in the first place!

TSCA does give EPA authority to require, on a case-by-case basis, testing or data development for new (as well as existing) chemicals.  And, for a small fraction of new chemicals, EPA has done so.  These are cases where EPA can meet the statutory burdens to require testing:

• In a classic Catch-22, EPA must already have substantial information about a chemical – enough to demonstrate that it "may present an unreasonable risk" or that it will be produced in large quantities and result in significant environmental releases or human exposures.
• EPA must also demonstrate that insufficient information exists to determine the effects of the chemical on health or the environment, and that testing is necessary to develop such information.

Arguably EPA has somewhat more leverage to compel testing of a new chemical relative to a chemical already in commerce.  Depending on the case, EPA can suspend its review of the PMN pending development of the data, or complete its review but include conditions that require testing prior to manufacture or impose controls pending completion of testing.  It can also negotiate a Consent Order (more on this below) or a Voluntary Testing Action in cases where PMN submitters agree on the need for testing.

Where EPA imposes a prohibition or limitation on a new chemical while testing is done, TSCA requires that any such controls be temporary and no longer apply upon submission of the specified information (see TSCA Section 5(e)).  Any permanent regulation of a new chemical would still require EPA to find that it "presents or will present an unreasonable risk" – the same near-impossible burden that applies to existing chemicals under Section 6 of TSCA (see TSCA Section 5(f)).

Just how often EPA has compelled or negotiated testing is unclear, as EPA has never publicly reported such data without lumping them together with other actions it has taken on new chemicals.  What is known is that EPA has taken action of some sort on fewer than 10% of the PMNs it has reviewed, only a fraction of which entail testing obligations.

One bite at the apple:  EPA typically gets only a single opportunity to review a new chemical.

TSCA grants EPA typically only one bite at the apple for new chemicals – a one-time, 90-day review opportunity at the premanufacture stage that takes place well before the full picture of the actual production, use and exposure, and lifecycle impacts of a chemical has emerged.

Once that review is completed and manufacture commences, the new chemical is placed on the TSCA Inventory, becomes an "existing" chemical, and any company can manufacture and use it without even having to notify EPA it is doing so.

In the relatively rare cases that EPA imposes any conditions or testing requirements on a new chemical, they apply only to the original notifier – unless EPA decides to go through a wholly separate rulemaking process to promulgate what is called a Significant New Use Rule (SNUR) specific to that chemical. 

EPA has issued SNURs for about 7% of new chemicals.  They typically specify the same conditions imposed on the original notifier, and extend them to any other manufacturer that wants to begin producing the chemical.  If – and only if – such a company wants to produce or use the chemical in a manner that falls outside of the conditions specified in the SNUR, it must first notify EPA.

SNURs themselves only require notification so that EPA can review the new use, and do not themselves impose new regulatory controls.  To do that, EPA would have to either promulgate yet another regulation or negotiate a Consent Order with the new company. 

All that just to ensure proper use of one new chemical.

Here again, TSCA is out of step with the laws of other developed countries.  Both Canada and the European Union have tiered notification and assessment processes for new chemicals.  As a chemical enters commerce and its production volume increases, these countries require additional notifications, impose additional data requirements and provide for renewed scrutiny by government.

Crystal-ball gazing:  EPA has to try to anticipate a new chemical's for-all-time future production and use.

The lack of up-front hazard data requirements for new chemicals under TSCA reflects in part the fact that notification takes place at a relatively early point in the course of developing, manufacturing, and marketing a new chemical, when it may not be realistic to expect a company to have conducted much testing.  Government intervention at this stage has the advantage of flagging overt potential concerns before manufacturing has commenced and before significant financial investment has been made by the producer.  It also has the potential to allow redesign of the manufacturing process or the chemical itself to eliminate or reduce the concern in advance of commercialization.

However, the lack of data on a chemical's hazards and other properties, combined with the rather speculative nature of information a company provides in its PMN on the chemical's potential uses, releases, and exposures, severely limits the robustness of any risk evaluation conducted at this stage.  And for the vast majority of new chemicals, no matter how significant a change in production or use occurs subsequently, a company is not even required to let EPA know it's happened.

Essentially, EPA has a single, highly time- and data-constrained opportunity to gaze into a crystal ball to predict the for-all-time trajectory of a chemical's production, use and disposal – and if it guesses wrong, EPA's only remaining regulatory recourse is under Section 6 of TSCA.  And recall that EPA has almost never succeeded in using its Section 6 authority to control dangerous substances, failing even to ban asbestos.

Black box:  New chemical reviews lack transparency.

I often hear from EPA staff that its new chemical reviews really are well-done and protective – they just can't reveal enough of the details to convince me of that fact.

Three major factors render EPA's review of new chemicals largely opaque to the public.

First, and perhaps most understandable, TSCA highly constrains how EPA can handle any information it receives that the submitter claims to be confidential business information (CBI).  CBI designations for new chemicals are the absolute norm: about 95% of PMNs contain information, including chemical identity, designated by the submitter as CBI.  As I have discussed elsewhere, both the latitude with which CBI claims can be asserted under TSCA and the constraints that apply to EPA in handling such information (including risking criminal charges and imprisonment for its wrongful disclosure; see TSCA Section 14(d)) have yielded a culture and practice at EPA that bends over backwards to prevent disclosure at all costs.

Second, because TSCA's requirements for developing test rules or regulatory controls are so onerous with regard to time, resources and evidentiary burdens, EPA instead resorts to using Section 5(e) Consent Orders to impose such requirements on new chemicals.  Over the course of TSCA's life, EPA has issued well over 1,000 such Consent Orders, compared to 4 – that's right, 4 – regulatory restrictions on new chemicals under its Section 5(f) authority.

However, although it is not prohibited from doing so, EPA rarely makes its Consent Orders public, even in redacted form to remove CBI.  This is because, according to EPA staff, these documents need not be made public because they are considered products of adjudication.  (In contrast, if EPA follows up a Consent Order with a SNUR, the latter is a regulation subject to full notice and comment, and hence, disclosure.)

Finally, it is exceedingly difficult to assemble even a rough, let alone accurate, picture of the number and nature of EPA decisions on new chemicals.  EPA does not publicly track such data even in the aggregate.  And on the few occasions it has published statistics on how often it has used various authorities or instruments to review or control new chemicals, the data lump together or obscure important facts – such as for how many new chemicals EPA has imposed a testing requirement.

Even within TSCA's constraints, EPA could certainly be far more transparent about – and engender more public confidence in – its review of new chemicals.  The fact that it has failed to do so says much about the need for statutory reform to shift the prevailing culture at EPA from one that errs on the side of keeping chemical information within its four walls, to one that affirmatively drives more and better information into the public domain.

Anti-precaution:  In deciding whether to require testing or controls for a new chemical, EPA equates absence of evidence of harm with evidence of no harm.

One of the best peeks into the black box I've had of late is when EPA took the unusual step of leaking a "sanitized" or CBI-redacted copy of a TSCA Section 5(e) Consent Order it negotiated with the manufacturer of a carbon nanotube.  I have already blogged at some length about this, here and here.  My angle here is to highlight again the decision logic EPA used, which staff tell me is not at all unusual in new chemical reviews at EPA.

In order to take action to control a new chemical – whether to impose conditions on use, restrict workplace exposures or disposal, anything – EPA must first find as a matter of law that the chemical "may present an unreasonable risk."  (To require testing only, EPA can alternatively find that a chemical will be produced in substantial quantities and may be result in significant release or exposure.)

EPA can and typically does make separate findings for human health and for the environment.  In the case of the carbon nanotubes, its basis for these different findings is telling:

• Human health: The Consent Order notes that this PMN was like most others in that no test data were submitted. EPA's actual finding, it would seem, logically follows: "EPA is unable to determine the potential for human health effects" from exposure to this nanomaterial, and hence it "may present an unreasonable risk of injury to human health." But the basis for this finding is not actually the absence of any test data for the nanotubes that are the subject of the PMN review. Rather, it is based on the existence of other affirmative evidence that certain carbon nanotubes act like asbestos. As a result, EPA is requiring one test to be performed, and imposing some modest restrictions on use and workplace exposures.
• Environment: One might think the wholesale absence of test data would be enough for EPA to conclude that it is also "unable to determine the potential for environmental effects as well." One would be wrong: The Consent Order actually affirmatively states that EPA has determined that "no significant environmental effects are expected." As a result, EPA is not requiring any testing for environmental effects and is not imposing any controls on environmental releases.

Given how little environmental data exist on nanomaterials in general, let alone this particular carbon nanotube, how could EPA have reached this conclusion? 

I'll repeat here what I said in my earlier post, because it bears repeating:  In reviewing a new chemical, EPA's decision logic is as follows:  Only if EPA already has evidence of a potential effect can it conclude that it is unable to determine whether there is an effect and call for testing.  If EPA doesn't have evidence of a potential effect – even if it has no data at all – it's ready to conclude that no significant effects are expected.

The precautionary principle, which the U.S. chemical industry so loves to malign, calls for initiation of proportionate action on a chemical where there is evidence of potentially dangerous impacts, even where that evidence is still incomplete or uncertain. 

That principle also underpins the European Union's REACH Regulation, which calls for the development of sufficient data on both new chemicals and those already in commerce, so as to be able to prioritize among them and act to control those that pose significant risks on an intelligent and well-informed basis

Some maintain that the New Chemicals Program is TSCA's version of precaution, arguing that it seeks to prevent harm before it happens.  But the example I've just provided suggests that, if anything, TSCA forces the New Chemicals Program to employ an anti-precautionary principle.

Next up:  I'll dissect the argument that EPA's Chemical Assessment and Management Program (ChAMP) is a model for TSCA reform.

In some nanotechnology circles, it is almost a mantra that, once released to the environment, nanoparticles will inevitably aggregate or agglomerate into larger masses and thereby lose their nanoscale-related properties and, by implication at least, any associated risks.

But can we count on nanoparticles released to the environment to self-regulate their own risk so conveniently?

For example, the National Nanotechnology Initiative prominently features on its website an article it commissioned, titled "Understanding Risk Assessment of Engineered Nanomaterials:  How can we know what is a risk and what is not?"  In a section designed to lead readers to question published studies that suggest nanomaterials might pose risks, the article says: "In solution or in air, it's quite difficult to keep nanomaterials separate, as they tend to clump in larger aggregates or agglomerates."  This is a point the author of this rather short article felt compelled to repeat twice more.

An FAQ issued by Germany's Federal Institute for Risk Assessment states that "nanoparticles tend to aggregate into larger unions which are generally larger than 100 nm. The toxic effects of nanoparticles linked to their small size and higher reactivity are then no longer relevant."

And a recent post on the blog of the nanotechnology practice group at Porter and Wright asserts that nanoparticles "have been shown to have fewer potential adverse health effects when they occur in cluster form (aggregates and/or agglomerates).  In the 'good news' department, scientists studying aerosol dispersion of nanoparticles have found they tend to cling together when dispersed into the environment." 

I won't even begin to try to lay out here how much more complex and unpredictable than this nanoparticle aggregation and environmental fate and transport are in the real-world.  Instead, let me just cite two excellent papers that do so:  see Maynard and Weisner et al.

But I do want to briefly discuss and cite some recent studies supporting three reasons why we can't count on nanoparticles released to the environment to self-regulate their own risk so conveniently: 

1.  Some nanomaterials can be stabilized as nanoscale particles in solution under environmental conditions.  A number of studies have found that carbon-based nanomaterials – despite their inherently very low water solubility – can be "solubilized," that is, can enter and remain in stable suspensions upon interaction with water or with other common, naturally occurring substances.  The latest study, authored by Salonen et al. and published in the journal Small, finds that C₇₀ fullerenes can form "stable, homogeneous suspensions" in water through interaction with ubiquitous phenolic acids that are present in and released from virtually all plant matter.  It appears that individual C₇₀ fullerenes first become coated with the phenolic acid, and then form small, loose clusters with diameters on the order of a few nanometers.  This study merited a "spotlight" on the Nanowerk website.

Earlier work has found similar behavior:  Fortner et al. identified the formation of stable suspensions of "nanocrystals" of C₆₀ fullerenes in water – nanoscale (25-500 nm diameter) aggregates they call "nano-C₆₀" that have entirely shed the extreme hydrophobicity of the individual fullerenes.  Hyung et al. found that multi-walled carbon nanotubes could be stabilized as individual particles through interaction with natural organic matter found in river waters; the natural material actually worked better than commonly used surfactants selected to serve that same solubilizing function.

2.  For performance reasons, nanoparticles are being actively engineered not to clump.  For most nanomaterial applications, optimal performance depends on minimizing any disordered clumping or even maximizing dispersal, so that the properties of individual nanoparticles or highly ordered nanostructures can fully exert themselves.  For this reason, researchers are working overtime to coat, cap, chemically modify or otherwise force nanoparticles not to aggregate or agglomerate.  See, for example, Yang et al.'s use of special capping agents to prevent aggregation of platinum nanoparticles, and Nadagouda and Varma's similar work with silver and palladium nanoparticles.  Similar efforts have been mounted to chemically modify ceramic nanoparticles to ensure dispersal.

So even to the extent that native or current forms of nanoparticles do readily clump or retain their hydrophobicity, any assumption that engineered nanomaterials entering commerce and the environment will inevitably do so is wholly unwarranted.

3.  Even agglomerated or clumped nanoparticles can be toxic.  The assumption that aggregated nanoparticles lose all of their nanoscale properties or become benign is also unwarranted.  Maynard and Kuempel have amply demonstrated that even large aggregates on individual nanoparticles typically retain many of their nanostructural features and properties.  But what about toxicity?

Fortner et al. found that their fullerene nanocrystals exhibited antimicrobial activity, suppressing bacterial growth and respiration.  In addition to confirming nano-C₆₀'s antibacterial activity, a recent paper by Lyon and Alvarez cited a number of studies demonstrating that the formation of these nanoscale aggregates in water yields a material with high toxicity to aquatic invertebrates, fish and the cells of higher organisms.  The aggregates have also been shown to enter and accumulate in those cells and to adhere to lipids.

Finally, Salonen et al. showed that their phenolic acid-coated C₇₀ clusters could readily translocate across the membranes of human cells in culture and enter the membrane surrounding the cell nucleus.  Moreover, they induced the contraction and ultimate death of those cells – ironically, apparently by aggregating into micro-sized particles through interaction with the cell membranes.

Once again, we find that nanomaterials' actual behavior confounds conventional wisdom and, when approaching their toxicology, forces us to question or abandon our assumptions and biases.

Ah, summer!  It’s a great time to be outdoors, enjoying the warm, sunny weather.  Before you go outside, be sure to grab your sunscreen, that essential product that protects against skin cancer and sun damage.  But which kind of sunscreen is best?  There is a mesmerizing array of sunscreen options, but for our purposes let’s limit the question to one:  Nano or not nano?

We all recall the white noses of the beach lifeguards.  The zinc oxide or titanium dioxide in these nose-protecting potions form a thick, white barrier that blocks damaging ultraviolet (UV) radiation by reflecting and scattering light.  These days, nanoscale titanium dioxide and zinc oxide are increasingly popular sunscreen ingredients, as they provide a UV barrier but are nearly transparent.

One of the concerns raised by using nanoscale titanium dioxide and zinc oxide in sunscreens is the dearth of safety data on potential health that could arise from applying nanoscale minerals to the skin on a daily basis – including to skin that may be damaged (e.g., already sunburned).  The sunscreens are then released into lakes or oceans, or washed down the drain with the bathwater with unknown environmental effects.

First, it must be pointed out that the same concern – lack of adequate safety data — applies to many of the traditional chemical sunscreen ingredients.  Nanoscale materials may require additional scrutiny, however, because their properties can differ from their bulk-scale counterparts.

Some environmental advocacy groups, such as Friends of the Earth, citing the lack of safety data and unclear product labeling, have called on the Food and Drug Administration to require more testing and exercise better regulatory oversight.  Meanwhile, because of these problems, Friends of the Earth ranks nanomaterial-containing sunscreens among the worst. 

In contrast, Environmental Working Group, while recognizing the critical data gaps, generally ranks sunscreens with nanoscale zinc and titanium oxides as having a lower hazard than those containing the most common active ingredients, such as oxybenzone and octyl methoxycinnamate.  As summarized by EWG, these non-nano ingredients are linked to a number of health hazards, including cancer and developmental and reproductive toxicity.  EWG argues that, in addition to being more effective, sunscreens made with nanoscale zinc and titanium oxides generally contain fewer hazardous ingredients overall. 

A range of opinions regarding nanoscale zinc and titanium oxides are available on popular websites, including Treehugger, Huffington Post, and the Green Guide.  The one thing everyone seems to agree on is that the lack of adequate safety data makes it hard to draw definitive conclusions regarding the safety of nanomaterials in sunscreens. 

The US Food and Drug Administration will soon be updating its “Sunscreen Monograph” – the regulatory document that specifies what chemicals can be used in sunscreen formulations, and in what concentrations.  This is a clear opportunity for FDA to be more proactive, by requiring that more data be developed to demonstrate sunscreen ingredient safety, and that more data be made publicly available so that consumers can make better-informed choices. 

In the meantime, if we are to avoid the real harm that over-exposure to the sun can cause, we have little choice but to select among sunscreen formulations — all of which contain insufficiently tested ingredients — hoping that whatever we do is better than the burn.

 Scott Walsh, MBA, is a Project Manager.

Nanotechnology is a global phenomenon:  Organizations all over the world are working to develop and deploy nanotechnology applications.  Interest in minimizing the potential health, environmental and safety risks of nanotechnology is similarly global.  One of many indications:  Over the past year, EDF and DuPont's Nano Risk Framework  has been downloaded more than 3,000 times in nearly 100 countries. 

Recognizing the international interest in the Framework, EDF and DuPont have now made it available in three major languages: Mandarin, French, and Spanish. (The Framework's executive summary is also available in Portuguese.) These translations will allow organizations around the world to better understand and apply the Framework's guidance to assess, mitigate, and communicate about potential nanomaterial risks.

EDF and DuPont launched a partnership in September 2005 to develop a systematic and disciplined process for evaluating and addressing the environmental, health and safety risks of nanomaterials across all stages of a product’s lifecycle – from initial sourcing through manufacture, use and recycling or disposal.  One of the goals of our partnership was to provide input into the ongoing development of policies and practices to address potential nano risks.

A few examples show that our work has had a broad reach:  The Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials, for example, has said it has benefited from the Framework as practical input into its nanotechnology programs.  Lloyd's, the UK's famous insurance syndicate, has encouraged insurers "to seek evidence of whether projects they are covering have followed this Framework." Here in the U.S., the Framework has been praised by companies ranging from large multinationals like GE to small startups like Nanostellar. 

In developing the Framework, we collected feedback from nanotechnology stakeholders around the world.  In translating the Framework, we hope to return the favor by making this guidance more accessible to more people across the globe, whether they live in Brasilia or Beijing, Madrid or Marseilles.  When it comes to nanotechnology safety, in more ways than one, it's a small world after all.

Scott Walsh, MBA, is a Project Manager.

As we've noted in this blog and elsewhere, there's a ton of uncertainty out there about what potential risks may arise from the production, use and disposal of engineered nanomaterials.  And unfortunately for companies trying to work with such materials (and the rest of us who may be exposed to them), there's still not much guidance on how to identify, manage and mitigate potential risks. 

On April 2nd and April 8th, Terry Medley and Keith Swain from DuPont and I will be leading two interactive workshops on nano risk management.  

We will explain to workshop participants the need for, and benefits of, nano-specific risk management.  We'll also show how companies can use tools like the Nano Risk Framework that EDF and DuPont developed to assess, manage and communicate the potential risks of nanomaterials. 

The workshops will discuss how to implement a sound management program; provide case studies of approaches in use by companies and governments; and offer sources of additional help for companies interested in adopting these approaches.

Register for the April 2nd workshop in San Francisco here or by contacting Lesley Fore at Lesley.Fore@GreenBlue.org

Register for the Tuesday, April 8th workshop in Boston here. 

Space is limited, so please register promptly!

In the current regulatory environment, where there are no regulations that specifically take into account the unique properties of engineered nanomaterials, industry has by default the primary responsibility for their safe production and use. Is industry taking this responsibility seriously?

Two recent studies, one in Europe and one in the U.S., shed light on this question and reveal some reasons to be concerned.

Helland et al. (2008) distributed a written questionnaire to 135 companies in Germany and Switzerland. Forty companies completed the questionnaire (representing a 30% response rate). Interestingly, most respondents believed that there is a very low potential for direct exposure to or environmental release of nanomaterials throughout the life cycle of their nanomaterials (production, consumption, and disposal). Only four companies, however, reported having any actual data relevant to assessing these potentials.

Most of the respondents said they believe their current risk assessment procedures are sufficient to evaluate nanomaterials, and that safety measures currently in place are adequate. Yet sixty five percent of the companies completing surveys had not conducted any assessment of risk.

The results of this survey seem to indicate that, for many companies, something more akin to wishful thinking is currently substituting for actual data and risk assessments.

Similar results were obtained in a survey by Lindberg and Quinn (2007) of small – medium sized nanotechnology companies in Massachusetts, which found that, while the larger companies believe that they are managing risks appropriately, they are basing their assessments on very little data. Not only are smaller companies not addressing risks, but they are more likely to believe that risks are unlikely.

Helland et al. conclude that, in general, industry lacks a “systematic approach to assessing … risks.” Furthermore, they suggest that the limited attention paid to assessing risks may result in underestimating both hazard and exposure, and hence raise questions regarding the adequacy of the precautions that are being taken.

Happily, some guidance is emerging for companies to use in identifying, assessing and mitigating potential risks of their nanomaterials and associated products. The Nano Risk Framework, developed jointly by Environmental Defense and DuPont, is one example of a small but growing number of efforts to develop a systematic approach to assessing risks and offering recommendations for data development and decision making throughout the product lifecycle. The National Institute for Occupational Safety and Health and the British Standards Institute have also prepared information to help guide occupational exposure assessment and mitigation. These “how to” guides can help companies to steer clear of questionable assumptions that seem to form the current foundation of many industry assessments of nanomaterial risks.

While it can help, making guidance available is of course not sufficient to ensure companies actually assess and sufficiently address potential risks. Helland et al. conclude that “Developing proactive risk management strategies appears to be an urgent task for minimizing the risk of harm to the environment and the public health.” In light of industry’s positive self-assessment of its current risk management efforts, both the public and private sectors need to put in place mechanisms to ensure such efforts amount to more than merely wishful thinking.