# General	Comments	at the IRIS	December	Bi - Monthly Meeting

Ro bert F ens te rheim, MPH Re gNet En vir onmen ta l Wa shington, DC December 13, 201313 December 2013 2 

# Agenda

• Stopping Rules Documen t • Re sear ch • Opportunities for NCE A T o Pr omot e/Upgr ades Science/Quality of Assessmen ts • Imaginary/Futuris tic St ep 1 and St ep 4 Meetings • We ll Deserv ed Complimen ts

## STO PPING	R

ULES 13 December 2013 313 December 2013 5 Page 2 IRIS Stopping Rules 07/31/1313 December 2013 5 

# Stopping Ru les	Need Revision

• Stopping Rules (SR) documen t intended to ser ve useful purpose to contr ol when new information will be consider ed and not dela y pr ogr ess • As writte n, giv es some “misimpr essions” but mor e import an tly

, could be in te rpr eted to limit opportunity/in te re stt o upgr ade the science **Some Concerns:** • Published/Unpublished • Re sear ch13 December 2013 6 

## Stopping Ru les:	Published/Unpublished Impr ession giv en that EP

A will only re ly only on publications published, accept ed and (perhaps) submitte d While journal publication is import an t, should not be a condition pr eceden t to EP A’ s use Note: R ecogniz es this ma y not ha ve been EP A’ s intent and that the IRIS Office will ( and has) used unpublished st udies (r ecen t Ev idence T ables ) If correct, wh y not reflect this in a revised SR document.13 December 2013 7 

# Stopping	R

ules: Re search SR c an be misin te rpreted to give impression that the IRIS pr ogr am does not c ar e much about resear ch. SR documen t sa ys : • Aft er St ep 1 meeting: “EP A will no long er c onsider studies unless they ha ve been accept ed for public ation” SR does not t ake in to c onsider ation that St ep 1 meeting migh t iden tify uncert ain ties, dat a needs that c ould signific an tly reduce the uncert ain ties and enhance the quality of the subject chemic al assessmen t and/ or even a br oader t opic. Also , studies/dat a g ener ated ma y not g et submitte d for public ation

# Imagine: Stakeholder Meeting #5

13 December 2013 813 December 2013 9 

# IMAGINE: Step1	Meeting IRIS Office pr esen ts pr eliminary ev aluation including: • Pr oblem F ormulation (if not pr eviously pr esen te d) and/or updates since Meeting #3 (or las t time EP A pr esen te d) • Ke y fea tur es/obser vat ions fr om e xpanded, qualit ative and qualit ative E vidence T

ables including pr eliminary ta ke on: • Endpoints of lik ely concern and associated ke y st udies • Uncertainties/limitations thus far identified • Po ssible ways t o addr ess uncert ainties/limitations including r esear ch initiativ es both short and longer term potentially e xtending beyond the timeline fo r the curr ent IRIS assessment • Science - policy issues tha t need to get sorted out and appr oaches being consider ed • How the issues on subject chemical might r elate to other chemicals and/or other things going on13 December 2013 10 

# IMAGINE: Step1	Meeting EP A’ s pr eliminary per spectiv es on what commenter s had to sa y, as a lead in to a r obus t dialogue including: • Chang es being consider ed based on commen ts • New issues that might need to be r evisited • Ques tions/confusions that need clarification **NO TE:**  A large r r oom might be needed because Stakeholder s will be in te re ste d in hearing discussions fir st - hand EP A’ s views Academics will be ther e t o get insight into r esear ch that they migh t want to undertake (and ma ybe funding ).13 December 2013 11 

# Imagine:	Step	4	Meeting New F ormat, which was adopted during Stak eholder Meeting #5 Ra ther than Stakeholder s present a summary of their writte n comments, EP

A would start by pr esen ting not jus t an over view of the dr aft assessment, but allocate mor e atte nt ion to: • Highligh ts fr om public comments r eceiv ed, including pr eliminary views on: • Issues EP

A intends (or is considering) r evisiting befor e peer r eview • Issues EP

A is not inclined to addr ess and wh y • Issues EP

A did not fully under sta nd/needs further discussion • Issues tha t trig ger policy/ br oader consider at ion tha t ar e cr oss cut ting (e.g., pooling epi da ta) • EP A pr eliminary plans for ne xt s te ps

# We ll - Deserved	Compliments