{"id":2453,"date":"2012-11-14T11:42:28","date_gmt":"2012-11-14T16:42:28","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/?p=2453"},"modified":"2024-02-12T11:01:26","modified_gmt":"2024-02-12T16:01:26","slug":"edf-comments-at-epas-public-stakeholder-meeting-on-its-iris-program","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2012\/11\/14\/edf-comments-at-epas-public-stakeholder-meeting-on-its-iris-program\/","title":{"rendered":"EDF comments at EPA’s public stakeholder meeting on its IRIS Program"},"content":{"rendered":"

Richard Denison, Ph.D.<\/em>, is a Senior Scientist.<\/em><\/p>\n

I provide in this post the comments I delivered as a panelist at the Environmental Protection Agency’s (EPA’s) November 13, 2012 Public Stakeholder Meeting<\/a> on its Integrated Risk Information System (IRIS) program.\u00a0 EPA describes IRIS<\/a> as “a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants.” <\/span><\/span><\/p>\n

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The theme of my comments today is the critical need to restore balance to the IRIS program.\u00a0 In my view, the program\u2019s structure and practice have over time tilted badly toward allowing one set of interests and desirable attributes of chemical assessments to wholly dominate over another, equally critical set.\u00a0 Let me explain.\u00a0 <\/span><\/span><\/p>\n

Scientific quality vs. Timeliness<\/span><\/span><\/strong><\/p>\n

I\u2019ll start with one pair of competing objectives:\u00a0 on the one hand, to ensure that assessments and their underlying data are of high scientific quality; and on the other hand, to ensure assessments are timely and do not unduly delay actions needed to address risks.<\/span><\/span><\/p>\n

IRIS has repeatedly allowed the demands for more and more \u201ccertain\u201d data to essentially indefinitely delay completion of it assessments.\u00a0 Despite the goal IRIS set in 2009 of completing most or all assessments in 23 months \u2013 and adhering to deadlines for each step in the IRIS process that would allow it to meet that goal \u2013 not a single assessment issued since then has met that timeline.\u00a0 Nor have any of them met any of the deadlines for the individual steps in the process<\/em>.\u00a0 The average completion time of these assessments, <\/span>according to GAO<\/span><\/a>, has been 7.5 years \u2013 nearly four times longer than the program\u2019s goal of 23 months<\/em>.<\/span><\/span><\/p>\n

These delays have profound real-world consequences:\u00a0 They allow continued exposure and harm to health from the subject chemicals \u2013 because decisions that rely on IRIS are also delayed:\u00a0 Simply put, a decision delayed is health protection denied.<\/em><\/strong><\/span><\/span><\/p>\n

As the National Academy of Sciences (NAS) stated in its 2009 report <\/span>Science and Decisions<\/span><\/em><\/a> (page 72):\u00a0 \u201cThe design of a risk-assessment process should balance the pursuit of individual attributes of technical quality in the assessment and the competing attribute of timeliness of input into decision-making.\u201d<\/span><\/span><\/p>\n

The fact is scientific information is ALWAYS incomplete and evolving.\u00a0 Assessments must \u2013 in all but the most exceptional of circumstances \u2013 be based on information already at hand<\/em>.\u00a0 The practice of waiting for one more study to be completed, as has happened repeatedly under IRIS \u2013 especially when that study is to be conducted by an entity with a vested financial interest in tilting the outcome \u2013 simply must stop.\u00a0 <\/span><\/span><\/p>\n

Of course, the science will evolve and improve over time; the best way to accommodate this reality is through a robust process for updating IRIS assessments periodically over time.<\/span><\/span><\/p>\n

Realistic but aggressive timelines must be set \u2013 and rigorously adhered to.\u00a0 In their absence, all<\/em> of the incentives are toward delay.\u00a0 And under our system where a pending assessment means no action can be taken, all of the rewards of delay fall to one side \u2013 the (un)regulated industry \u2013 and all of the risks fall on the public<\/em><\/strong>.<\/span><\/span><\/p>\n

Clear consequences must follow if deadlines are missed; two options that I support are first, reliance on conservative interim default risk values and second, restrictions of expanding production and use of a chemical, pending completion of its assessment.\u00a0 Such measures will ensure that the incentives point toward timely completion of assessments, and that risks arising from continued exposure to such chemicals are at least not increased before those risks are quantified.<\/span><\/span><\/p>\n

A robust tracking system that accurately reports the precise status of each IRIS assessment from start to finish \u2013 and flags and clearly explains the reason for any delay \u2013 is essential to ensure an accountable process.<\/span><\/span><\/p>\n

Transparency and \u201cdue process\u201d vs. Ensuring balanced input<\/span><\/span><\/strong><\/p>\n

This is the second set of competing interests.\u00a0 Over time, with some ups and downs, the tendency for IRIS has been to respond to criticism by adding more steps to its process for conducting assessments.\u00a0 The result is a process that is, again, badly out of balance.<\/span><\/span><\/p>\n

It may seem strange to hear this from a representative of the public interest community, but what IRIS needs is fewer, not more, opportunities for \u201cpublic\u201d input.\u00a0 It\u2019s indisputable that <\/span>a more involved process with more steps is a major contributor to the delays that have plagued the IRIS program<\/span><\/a>.\u00a0 But the problem goes deeper than that:\u00a0 More opportunities for input not only require more time, they also result in a process that virtually ensures the input received by EPA is imbalanced and badly skewed toward the regulated community.\u00a0 <\/span><\/span><\/p>\n

Because companies that produce and use each chemical to be assessed \u2013 and the trade associations that represent them \u2013 have a clear vested financial interest in the outcome of the assessment, that factor will not surprisingly affect the content of their input.\u00a0 But it will also ensure they can and will take advantage of each and every opportunity for input they are provided.\u00a0 We simply must stop pretending that there is a level playing field.<\/em>\u00a0 It is a certitude that the affected industry will be better represented than other stakeholders at each opportunity for input, and the more such opportunities, the greater the imbalance becomes.<\/span><\/span><\/p>\n

Rather than adding more steps, what is needed is a further consolidation of the IRIS process<\/em>.\u00a0 Input should be solicited in one step at the beginning of the process \u2013 to get stakeholder input on the scope of the assessment; to identify key issues, available data and data gaps, and so on.\u00a0 Once a draft assessment is completed, a second round of input should be solicited, again in one step, on the draft, questions that the peer review should address, and so on.\u00a0 EPA should then consider that input in proceeding to finalize and issue the final assessment.\u00a0 Such a process will provide ample opportunity for input and due process, while reducing the imbalance in the type of input EPA receives.<\/span><\/span><\/p>\n

Final observations<\/span><\/span><\/strong><\/p>\n

Finally, I feel compelled to offer my view, based on years of working in this arena, that the chemical industry has never shown real interest in actually seeing the IRIS program succeed.<\/span><\/span><\/p>\n

How else does one explain its <\/span>long history of seeking to delay or undermine IRIS assessments<\/span><\/a>?\u00a0 Or the <\/span>American Chemistry Council\u2019s demand<\/span><\/a> that ALL draft IRIS assessments be sent to the NAS for review, knowing full well that this step will add upwards of $1 million and at least two years to each review?\u00a0 Even that\u2019s not enough for ACC:\u00a0 It also is demanding that ALL revised IRIS documents be sent back AGAIN to NAS for yet another review, with the same price tag and delay.<\/span><\/span><\/p>\n

Nor is IRIS the sole target of this chemical industry assault on independent government science.\u00a0 ACC and its allies in Congress:<\/span><\/span><\/p>\n