Use of IRIS Project: Preliminary Findings

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Use of IRIS Project Preliminary Findings

• Jim Solyst
• Principal Consultant
• ENVIRON International Corporation
• Arlington, VA
• jsolyst_at_environcorp.com
• 703-516-2330

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Development of an Analytical Approach to
Determine How the EPAs IRIS is used by Non-EPA
Decision Makers

• Use of IRIS Project
• Work Plan Elements
• Develop Categorized List of non-EPA Users
• Develop Approach for Gathering Information
• Gather Useful Information from Sources to Assess
  how External Users Use IRIS
• Produce a report Summarizing the Information
  Collected
• Develop Suggestions for a Pilot Program

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IRIS Related Background of Project Manager
1982-1984 - National Governors Association
Cooperative Agreement with EPA ORD to provide
risk assessment assistance to state
officials 1987 IRIS pilot project 1994-2006
- American Chemistry Council Developed
policy on IRIS 2007 - ENVIRON International
Corporation Health Sciences firm, risk
assessment expertise Clients are impacted by
IRIS
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Categorized List of IRIS Users
Primary Categories Federal government agencies
state agencies industry, academia, NGOs,
research organizations, global. Sub category
examples State agencies Environmental
regulatory agency Agency able to supplement
IRIS file Agency with limited toxicology staff
resources Public Health Department Department
which provides technical/scientific/toxicological
services to the regulatory agency. Sub
categories evolve as information is
collected For example UK University Institute
for Environment and Health
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Approach for Information Gathering
A survey was not conducted it would not be the
best method to collect information. Interviews
were conducted with representatives from the
categories and sub-categories of IRIS
customers. Interviewees were not representing
their organization or agency quotes would not be
attributed to them rather their views are
considered to be representative of a
sub-category. However, some interviewees did
provide publicly available information presenting
a position on IRIS. Interviews varied in length,
atmosphere (phone or face-to face group or
individual) but the same material was covered for
each interview.
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Sub Categories Interviewed
Federal agency that is a regulated
party Agency 1 In-person with two staff and
10 staff from various programs and
centerson a conference call. Agency 2 In
person with two Washington, D.C. based staff
members Federal agency that is not a regulated
party Agency 3 One person director of a
toxicology unit, on the phone State
environmental regulatory agency with toxicology
resources Agency 1 Six staff, in
person Agency 2 Four staff, in person State
environmental regulatory agency with no
toxicology resources Agency 1 One staff
director of the risk assessment unit two phone
conversations State public health department
which provides toxicology services to the
regulatory agency Agency 1 One staff
toxicologist, in person
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Sub Categories Interviewed
Large chemical company Company 1 In-person
meeting with a senior toxicologist followed by a
conference call with 4 additional
toxicologists Company 2 In-person meeting with
a senior toxicologist followed by
conversation followed by a conference call
with 2 toxicologists Large chemical user
(downstream) company Company 1 In-person
meeting with two toxicologists and one
sustainability green chemistry
expert Company 2 Phone conversation with a
research toxicologist Research
organization Organization 1 Phone
conversation with senior researcher. Organization
2 Email correspondence with two senior
researchers
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Sub Categories Interviewed
NGOs Organization 1 In-person meeting with
Washington-based senior toxicologist
Organization 2 In-person meeting with database
developer (not a toxicologist) Trade
Association for Downstream Chemical
Users Organization 1 In-person meeting with
senior toxicologist Non-US Institution Univ
ersity 1 Phone interview with program director
and email correspondence
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Findings
Frequent users want to talk about IRIS Everyone
contacted was willing to discuss their IRIS
experiences all felt the project was
worthwhile. Frequent users are homogenous are
typically toxicologists or in related
disciplines They view as IRIS as being intended
for them, not the general public or other
non-technical people.
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Findings

• Frequent users like IRIS
• The way information is presented
• The template
• Certain features, such as the definitions of
  terms.
• Most importantly, they like the concept of IRIS
  a peer reviewed EPA consensus database.
• That phrase -- peer reviewed, EPA consensus
• Cited by all frequent uses
• What distinguishes IRIS from all other chemical
  databases.
• No comparable product certainly not in the US
  and not globally, at least not that the
  interviewed customers are aware of.

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Findings

• Two Broad categories of Frequent Users
• Those who use IRIS as a chemical database a
  premier database but one of several
• Those who are dependent on IRIS as a regulatory
  driver or indicator.
• Frequent users can be part of both categories,
  depending on their needs at the time
• But usually it is the regulatory agencies and the
  regulated parties which are dependent on IRIS
• Meaning there is no other database which
  provides a comparable regulatory service.

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Findings
Frequent customers use other chemical databases,
but IRIS is always in the top tier and usually
the first database accessed. Other databases
include the California Toxicity Criteria
Database, ATSDR, NLM and EU databases, and
commercial databases. For domestic regulatory
purposes, IRIS is always the first, sometimes
required by statute/regulation or policy. Based
on limited data, IRIS is in the top tier globally
(as reported by UK university, UK based
consultant, and responsible parties.)
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Findings
IRIS as a product name is well known (state
regulatory agency commissioner What does IRIS
say about that chemical?) But, it is generally
not known as a NCEA or ORD product, it is
considered an EPA database. One state statute
requires the agency to first go to the
appropriate federal database when determining a
drinking water value the federal database is
almost always IRIS. IRIS file managers are
anonymous, even to Washington insiders. Some
frequent users know Dr. Preuss and at least two
said they had a heard a presentation by Dr.
Kadry, but few users have ever spoken to an IRIS
staff person. IRIS staff have no role in the
risk management process they are oblivious to
the impact of a file but EPA Regional office
staff do express views on IRIS file during
discussions with responsible parties all
Regions seem to have different views on IRIS in
general and specific files.
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Findings
A final IRIS file and a file in development are
viewed completely differently. A sub-set of
users (industry, NGOs) will offer comments,
studies, and analysis to EPA as a file is being
developed But once the file is final then they
accept it as the most important domestic
regulatory input. They may not agree with the
file, but they just have to get over it.
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Findings
Most frequent customers view IRIS file with a
critical eye, they are aware of the file date
or if the file is not as robust as other files.
In those cases, users will access other databases
and be more willing to conduct their own
analysis. But, an IRIS file -- regardless of its
date or completeness -- still rules. Thus, other
databases and primary sources can supplement IRIS
but never replace or supersede an IRIS file.
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Complaints
There is only one criticism of IRIS, but it is
significant customers are frustrated by the lack
of new files, particularly for controversial
chemicals. The absence of an IRIS file creates
enormous challenges for state regulatory
agencies significant uncertainly for regulatory
parties and disappointment for customers who use
IRIS as a chemicals database. Customers dont
understand the absence of key files they know
the data is out there, because they have to
access it themselves. They know values can be
derived, because they have to develop
values-standards-numbers themselves. Customers
usually think it is due to lack of resources,
some think it is may be industrys fault, but few
are sympathetic to the inherent difficulty of
issuing a file that is essentially a federal
consensus document. In the old days it went a
lot faster, what happened?
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Complaints
What happens in the absence of an IRIS
file? State regulatory agencies and chemical
manufactures and users conduct their own
literature reviews, analyze the data, and develop
values. This takes time and resources and thus
they are resentful. Plus, they must continually
justify their work whereas an IRIS file is
seldom challenged. Regulated parties dont know
what to expect and there is the likelihood of
different values issued by different
states. Researchers realize their work
article-- will be dated once an IRIS file is
finalized.
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Complaints
Is there any upside to this situation? It does
remind customers how valuable and essential IRIS
is. Out of necessity it has lead to the
development of expertise. There are now
examples of different approaches and outcomes for
a value setting process which could be put to
good use.
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Very Preliminary Conclusions
Some type of outreach by ORD is warranted and
would be welcomed by frequent users. Customers
believe the benefits of outreach would go both
ways. The chemical database (or
non-regulatory) service of IRIS could be
enhanced.