### Gener al Commen ts a t the IRIS December Bi - Mon thly Meeting Chuck Elkins, Consult an t, Wa shingto n, DC December 13, 2013

### Import ance of IRIS Enhancemen ts
• As a former dir ect or of EP A’ s TSCA pr ogram (and senior manag er in the air pollution and pes ticides pr ograms), I understa nd fir sthand the need for a s tr ong IRIS pr ogram as key to public health pr ot ection and guiding and pr eserving co nsumer choice.

– Fo r the las t sever al year s all of m y pr ofessional energies (both compensated and pr o bono) ha ve been focused on st re ngthening the IRIS pr ogr am.

– I am her e t oda y in m y pr o bono capacity. • I believe the enhancements as announced in July , 2013 should impr ove both IRIS quality and timeliness. • I will focus m y r emark s her e on St ep 1 Meetings

### Wha t I under sta nd the purpose of these St ep 1 meetings t o be
• Not jus t an e xe rc ise in democr acy • NCEA s ta ff want to change the IRIS:

– Its output

– The per ceiv ed or actual quality of the assessmen ts • Wh y ar e these changes needed?

– Issues that EP

A cannot ignor e that ar e r aised late in the pr ocess r equir e r esour ce - and time - in te nsiv e re work.

– It is much easier to write an assessment if you know most of the issues you mus t addr ess fr om the beginning so you can work the issues in par allel.

### Wha t did I e xpect of these St ep 1 mee tings based on EP

A’ s July state men ts? Atthe c onclusion, both s ta ke holders and EP A w ould w alk out with a clear under sta nding , for each chemic al, of what ar e the:

– Pr oblems the assessmen t is designed to addr ess (e.g. Pr ogr am office or s tate s’ curr en t needs)

– Health and eco endpoints that will be the focus

– Most important studies, and their identified str engths and weaknesses

– Ke y scien tific/science policy issues that mus t be addr essed in the assessmen t (e.g. kidney tumor s MOA)

– Re sear ch underw ay

, data g aps that could be filled quickly , and how “ stopping rules” will apply.

## My c onclusions
• I am v ery happy that this fir stmeeting t ook place. • But not one of m y e xpect ations w as fulfilled.



### Wha t w en t wr ong? • Lack of eng ag emen t by s ta ke holder s and EP A? No • “Shape of the t able”? No

## We re these Step 1 meetings held too early in the process?

### Wha t does NCE A know about St ep 1 chemic als and when does it know it? (My pr evious lis t)

– Pr oblems the assessmen t is designed to addr ess (e.g. Pr ogr am office or s tate s’ curr en t needs)

– Health and eco endpoints that will be the focus

– Most important studies, and their identified str engths and weaknesses

– Ke y scien tific/science policy issues that mus t be addr essed in the assessmen t

– Re sear ch underw ay

, data g aps that could be filled quickly , and how “ stopping rules” will apply.

## IRIS Timeline (fir sts te ps )
• Nomination • Pr oblem F ormulation • Lit er atur e sear ch & selection of pertinen t st udies • Ev idence t ables • Study ev aluation • Outline/plan the assessmen t • Iden tification of dif

ficult issues • Dr aft the assessmen t

## Curr en t Schedule of E arly Meetings
• Nomination • Pr oblem F ormulation • Lit er atur e sear ch & selection of pertinen t st udies • Ev idence t ables • Study ev aluation • Outline/plan assessmen t • Iden tification of dif

ficult issues • Dr aft the assessmen t

### A pr oposed Plan for St ep 1 Meetings
• Nomination • Pr oblem F ormulation • Lit er atur e sear ch & selection of pertinen t st udies • Ev idence t ables • Study ev aluation • Outline/plan assessmen t • Iden tification of dif

ficult issues • Dr aft the assessmen t

### A pr oposed Plan for St ep 1 Meeting
• Nomination = post on web • Pr oblem F ormulation • Lit er atur e sear ch & selection of pertinen t st udies • Ev idence t ables • Study ev aluation • Outline/plan assessmen t • Iden tification of dif

ficult issues • Dr aft the assessmen t

### This plan does not r equir e an y chang e to the July 2013 enhancemen ts • In fact, it is mor e consis te nt with what man y of us e xpect ed. • The number of meetings with s ta ke holder s re mains the same. • The meeting is s till a “St ep 1 meeting ” • The change is simply a change in timing to reflect when NCE A will be in a position t o ha ve a dialogue r ather than jus t lis te n and ask ques tions.

### Pr oposed Ag enda for a St ep 1 Meeting

• Thr ee - fo urths of the time t o be dev oted to sitting ar ound a ta ble discussing the difficult science issues in the forthcoming assessmen t

– EP A pr oposes for discussion ones it has identified

– St akeholders add other s, as necessary [It makes no sense for NCEA to plan the Step 1 meetings unilater ally] • A quarter of the time is open t o issues br ought forw ar d at the meeting by an yone. • The issues ar e discussed IN DEPTH by both EP A and sta ke holder s. This is NOT a “lis te ning session”

## Pr oposed ste ps the St ep 1 meeting
• St akeholders ha ve 30 da ys t o submit additional mat erial • Chemical manager r evises the plan for assessmen t t o addr ess these and other issues in r obus t & ef

ficien t fashion. • NCE A managemen t makes “go/no go” decision to do the assessmen t as planned and sets the deliv ery t arget dat e. • The “clock” sta rts a t this poin t and not befor e.

## Ke eping E vidence T

ables Curr en t
• Wh y is NCE A doing evidence t ables?

– Jus t to communicate with s ta ke holder s?

– Fundamen ta l building block of a good assessmen t? • Will NCE A be updating /c orr ecting these ta bles? • Wh y not pos t the updat ed/curr en t evidence ta bles on the web?

– St akeholder s (including those not her e)

– St ates and localities

### “**The une xa**  **mined lif e is not worth living**  **” (Socr** **ate s)**  • A success ful implemen tat ion re quir es concerted effort by both EP

A and sta ke holder s. • The implemen tat ion of these IRIS enhancemen ts is **too important** to lea ve un - ev aluated. • We need a **dock et**  to house on - going ev aluation of the performance by both EP A and s ta ke holder s in this effort.