General	Comments	at	the	

IRIS	December	Bi-Monthly	Meeting

Robert Fensterheim, MPH

RegNet Environmental 

Washington, DC

December 13, 2013
2 13 December 2013

Agenda

• Stopping Rules Document

• Research

• Opportunities for NCEA To Promote/Upgrades 

Science/Quality of Assessments

• Imaginary/Futuristic Step 1 and Step 4 Meetings

• Well Deserved Compliments
STOPPING	RULES

3 13 December 2013
5 13 December 2013

Page 2 

IRIS Stopping Rules 

07/31/13
5 13 December 2013

Stopping	Rules	Need	Revision

• Stopping Rules (SR) document intended to serve

useful purpose to control when new information will 

be considered and not delay progress

• As written, gives some “misimpressions” but more 

importantly, could be interpreted to limit 

opportunity/interest to upgrade the science

Some Concerns:

• Published/Unpublished

• Research
6 13 December 2013

Stopping	Rules:	Published/Unpublished

Impression given that EPA will only rely only on 

publications published, accepted and (perhaps) 

submitted 

While journal publication is important, should not be a 

condition precedent to EPA’s use 

Note: Recognizes this may not have been EPA’s intent 

and that the IRIS Office will (and has) used 

unpublished studies (recent Evidence Tables)

If correct, why not reflect this in a revised SR 

document.
7 13 December 2013

Stopping	Rules:	Research

SR can be misinterpreted to give impression that the IRIS program 

does not care much about research. SR document says:

• After Step 1 meeting: “EPA will no longer consider studies unless 

they have been accepted for publication” 

SR does not take into consideration that Step 1 meeting might 

identify uncertainties, data needs that could significantly reduce the 

uncertainties and enhance the quality of the subject chemical 

assessment and/or even a broader topic.

Also, studies/data generated may not get submitted for publication
Imagine: 

Stakeholder Meeting #5

8 13 December 2013
9 13 December 2013

IMAGINE:		Step1	Meeting

IRIS Office presents preliminary evaluation including:

• Problem Formulation (if not previously presented) and/or 

updates since Meeting #3 (or last time EPA presented)

• Key features/observations from expanded, qualitative and 

qualitative Evidence Tables including preliminary take on: 

• Endpoints of likely concern and associated key studies 

• Uncertainties/limitations thus far identified

• Possible ways to address uncertainties/limitations including research 

initiatives both short and longer term potentially extending beyond the 

timeline for the current IRIS assessment

• Science-policy issues that need to get sorted out and approaches being 

considered

• How the issues on subject chemical might relate to other chemicals 

and/or other things going on
10 13 December 2013

IMAGINE:		Step1	Meeting

EPA’s preliminary perspectives on what commenters had to say,

as a lead in to a robust dialogue including:

• Changes being considered based on comments

• New issues that might need to be revisited

• Questions/confusions that need clarification

NOTE: A larger room might be needed because Stakeholders 

will be interested in hearing discussions first-hand EPA’s views

Academics will be there to get insight into research that they 

might want to undertake (and maybe funding). 
11 13 December 2013

Imagine:	Step	4	Meeting

New Format, which was adopted during Stakeholder Meeting #5

Rather than Stakeholders present a summary of their written 

comments, EPA would start by presenting not just an overview of 

the draft assessment, but allocate more attention to: 

• Highlights from public comments received, including 

preliminary views on:

• Issues EPA intends (or is considering) revisiting before peer review 

• Issues EPA is not inclined to address and why 

• Issues EPA did not fully understand/needs further discussion

• Issues that trigger policy/ broader consideration that are cross cutting 

(e.g., pooling epi data) 

• EPA preliminary plans for next steps
Well-Deserved	Compliments