General Comments at the 

IRIS December Bi-Monthly Meeting

Chuck Elkins, Consultant,

Washington, DC

December 13, 2013
Importance of IRIS Enhancements

• As a former director of EPA’s TSCA program (and senior 

manager in the air pollution and pesticides programs), I 

understand first hand the need for a strong IRIS 

program as key to public health protection and guiding 

and preserving consumer choice.

– For the last several years all of my professional energies 

(both compensated and pro bono) have been focused on 

strengthening the IRIS program.

– I am here today in my pro bono capacity.

• I believe the enhancements as announced in July, 2013 

should improve both IRIS quality and timeliness.

• I will focus my remarks here on Step 1 Meetings
What I understand the purpose of 

these Step 1 meetings to be

• Not just an exercise in democracy

• NCEA staff want to change the IRIS:

– Its output

– The perceived or actual quality of the assessments

• Why are these changes needed?

– Issues that EPA cannot ignore that are raised late in the 

process require resource- and time-intensive rework.

– It is much easier to write an assessment if you know most 

of the issues you must address from the beginning so you 

can work the issues in parallel.
What did I expect of these Step 1 meetings 

based on EPA’s July statements?

At the conclusion, both stakeholders and EPA would walk 

out with a clear understanding, for each chemical, of 

what are the:

– Problems the assessment is designed to address (e.g. 

Program office or states’ current needs)

– Health and eco endpoints that will be the focus

– Most important studies, and their identified strengths 

and weaknesses

– Key scientific/science policy issues that must be 

addressed in the assessment (e.g. kidney tumors MOA)

– Research underway, data gaps that could be filled quickly, 

and how “stopping rules” will apply.
My conclusions

• I am very happy that this first meeting took 

place.

• But not one of my expectations was fulfilled. 

What went wrong?

• Lack of engagement by stakeholders and 

EPA? No

• “Shape of the table”? No
Were these Step 1 meetings 

held too early in the process?
What does NCEA know about Step 1 

chemicals and when does it know it?

(My previous list)

– Problems the assessment is designed to address (e.g. 

Program office or states’ current needs)

– Health and eco endpoints that will be the focus

– Most important studies, and their identified strengths 

and weaknesses

– Key scientific/science policy issues that must be 

addressed in the assessment

– Research underway, data gaps that could be filled quickly, 

and how “stopping rules” will apply.
IRIS Timeline (first steps)

• Nomination

• Problem Formulation

• Literature search & selection of pertinent 

studies

• Evidence tables

• Study evaluation

• Outline/plan the assessment

• Identification of difficult issues

• Draft the assessment
Current Schedule of Early Meetings

• Nomination

• Problem Formulation

• Literature search & selection of pertinent 

studies

• Evidence tables 

• Study evaluation

• Outline/plan assessment

• Identification of difficult issues

• Draft the assessment
A proposed Plan for Step 1 Meetings

• Nomination

• Problem Formulation 

• Literature search & selection of pertinent 

studies

• Evidence tables 

• Study evaluation

• Outline/plan assessment

• Identification of difficult issues 

• Draft the assessment
A proposed Plan for Step 1 Meeting

• Nomination = post on web

• Problem Formulation 

• Literature search & selection of pertinent 

studies 

• Evidence tables 

• Study evaluation 

• Outline/plan assessment

• Identification of difficult issues 

• Draft the assessment
This plan does not require any change 

to the July 2013 enhancements

• In fact, it is more consistent with what many 

of us expected.

• The number of meetings with stakeholders 

remains the same.

• The meeting is still a “Step 1 meeting”

• The change is simply a change in timing to

reflect when NCEA will be in a position to have

a dialogue rather than just listen and ask 

questions.
Proposed Agenda for a Step 1 Meeting

• Three-fourths of the time to be devoted to sitting around a 

table discussing the difficult science issues in the forthcoming 

assessment

– EPA proposes for discussion ones it has identified

– Stakeholders add others, as necessary [It makes no sense for NCEA to 

plan the Step 1 meetings unilaterally]

• A quarter of the time is open to issues brought forward at the 

meeting by anyone.

• The issues are discussed IN DEPTH by both EPA and 

stakeholders. This is NOT a “listening session”
Proposed steps the Step 1 meeting

• Stakeholders have 30 days to submit 

additional material

• Chemical manager revises the plan for 

assessment to address these and other issues 

in robust & efficient fashion.

• NCEA management makes “go/no go” decision 

to do the assessment as planned and sets the 

delivery target date.

• The “clock” starts at this point

and not before.

Keeping Evidence Tables Current

• Why is NCEA doing evidence tables?

– Just to communicate with stakeholders?

– Fundamental building block of a good 

assessment?

• Will NCEA be updating/correcting these 

tables?

• Why not post the updated/current evidence 

tables on the web?

– Stakeholders (including those not here)

– States and localities
“The unexamined life is not worth living”

(Socrates)

• A successful implementation requires concerted 

effort by both EPA and stakeholders.

• The implementation of these IRIS enhancements is 

too important to leave un-evaluated.

• We need a docket to house on-going evaluation of 

the performance by both EPA and stakeholders in 

this effort.