United SIMM
Environmental Protection
Agency
Office of
Solid Watte end
Emergency ftoeponeo
DIRECTIVE NUMBER: 9295.4-01
TITLE: MOD Between ORlTand OERR
APPROVAL DATE: "Iff? °
EFFECTIVE DATE: // f£f
-------
H I'lrective initiation Request I 9295.
4/01
of Contact Panon
David Bennett
attpnona oat
475-9486
3. Tiu«
MOU Between ORD and OERR
4. Summary of O'tctivf (includt enti statamant of purpose) '
Transmits MOU between OSWER and ORD for implementation of a cornnunicatons
and technical support network between Regions, Laboratoreis and HQ managemerit
units
9. Ktywora*
MOU
ft. Dot* It Supplamant Prtvious
LJNo
I I No | |v«« Whato>MtK«(nufnt«r.aa«
A-SJgnodbyAAVOAA
B - Sign* by Plto OHctof
^^^^
| | C -
f* *•*•« 4 Cofftnow
0 -
8. Document to b« dlttrlbuttd to Sttttt by Htadquarttrs? I I Y
Thl« M*4u«tt M»«a OSWEH OirtcUvu Sylttm format Stindarda.
9. Syvatuf* el lead Otfiea Oiracuvta Coordinaior
Betti C. VanEpps, OERR Directives Coordinator
10. Na/na and Titli of Approving 0"ioal
Henry L. "Longest II / Di rector,, QERR
Data
H/tfl*
"M / 4c-
i'f±/?C
EPA Form 131S*17 (Aav. $-17) Prtmeus Mfeona tn otadtata.
OSWER OSWER OSWER O
VE DIRECTIVE' DIRECTIVE DIRECTIVE
-------
,
3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
* WASHINGTON, D.C. 20460
NOV 5 1990
SOLID WASTE AND £ve»G£\C> RESPONSE
OSWER Directive 9295.4-01
MEMORANDUM
SUBJECT: Memorandum of Understarid/^g Between ORD and OERR
FROM: Henry L. Longest II
Director, OERR
_TP_:_ .Addressees
PURPOSE: The purpose of this memorandum is to transmit for
your records a copy of the Memorandum of Understanding (MOU)
between the Office of Solid Waste and Emergency Response (OSWER)
and the Office of Research and Development (ORD) which was signed
on M_arch 10, 1990.
BACKGROUND: In 1987, the Office of Solid Waste and
Emergency Response, the Regional Superfund Offices, and the
Office of Research and Development established the Superfund
Technical Support (TSP) project to organize and implement a
network for communications and technical support among the
Regions and Laboratories. Currently the project consists of five
Technical Support Centers (TSCs), each with its own specialty.
The attached document creates a sixth TSC to be located in the
Office of Health and Environmental Assesment (OHEA), with
Environmental Criteria and Assessment Office (ECAO), Cincinnati
identified as the focal point to coordinate the assessment of
human health and risk issues. The Toxics Integration Branch of
OERR is the designated contact to work with the TSP project
manager to establish and monitor the conduct and performance of
this Center.
OBJECTIVE AND IMPLEMENTATION: The addition of this
specialized Center will begin to meet the objective of
establishing-a- consistent approach to the coordination of
assessment of human health and risk issues. Toward this end, all
Superfund managers are directed to become familiar with this
Memorandum of Understanding and to begin immediately to utilize
the program outlined herein. Questions with respect to this
program should be directed to David Bennett, Director, Toxics
Integration Branch, OERR at 475-9486.
ADDRESSEES:
Waste Management Division Directors
Superfund Regional Branch Chiefs
OERR Division Directors and Branch Chiefs
Pruutd an Ricycltd Paptr .
-------
OSKER Directive 9255.4-G1
MEMORANDUM OF UNDERSTANDING
BETWEEN
THE OFFICE OF RESEARCH AND DEVELOPMENT
AND
THE OFFICE OF SOLID WASTE AND EMERGENCY RESPONSE
I. Purpose
The Office of Emergency and Remedial Response has
proposed the establishment of the Technology Support Center
(TSC) in the Office of Health and Environmental Assessment
(OHEA), Environmental Criteria Assessment Office,
Cincinnati, OH (ECAO-Cin) to address the human health risk
assessment issues pertinent to Superfund-related activities.
. This memorandum of understanding (MOU) establishes functions
and responsibilities for the TSC.
II. Authority
The Office of Solid Waste and Emergency Response
(OSWER), Regional Superfund Offices, and Office of Research
and Development (ORD) established the Superfund Technical
( Support Project (TSP) in 1987. The broad objectives of the
• TSP are to provide technical support and assistance to
regional staff; improve communications among regions and ORD
laboratories; ensure consistency in applications of
technologies; and furnish state-of-the-art science
information for remedial project managers (RPMs) and
on-scene coordinators (OSCs). The project consists of a
network of Regional Forums, four specialized technology
support centers (TSCs) located in ORD laboratories, and one
TSC at the Emergency Response Team (ERT). The specialties
and locations of the five TSCs are as
follows: groundwater fate and transport (RSKEL, Ada, OK);
engineering and treatment (RREL, Cincinnati, OH); monitoring
and site characterization (EMSL, Las Vegas, NV); exposure
and ecorisk assessment (ERL, Athens, GA); and hazardous
substances releases and response (ERT, Edison, NJ).
Regional technical personnel have established forums in
engineering- and treatment, and groundvater fate and
transport. Acting as technical resources, forum members
work to improve communications and assist in technical
transfer between the Regions and the Centers. Monthly
teleconferences and periodic TSP meetings are held by the
project manager in OSWER'S Office of Program Management and
Technology; - • --
-------
In setting up the TSCs, ORD designated the above
laboratories to respond to technical questions with respect
to the laboratory's specialties and expertise. Resources of
such assistance usually come from technical assistance and
enforcement support projects funded by the Agency's
Superfund Research Subcommittee. Even on an ad hoc basis,
however, such projects have limited abilities to be flexible
or to fashion more extensive site-specific support. TSP is
intended to address this inadequacy by encouraging the
regions to utilize their in-house expertise (through the
formation of regional technical support forums), and by
providing the TSC access to a pool of OSWER funds to
"procure" specific support from TSCs, or through the TSCs to
obtain certain expertise inside or outside the Agency.
This MOU proposes the establishment of the 6th TSC in
the Office of Health and Environmental Assessment with ECAO-
Cin identified as the focal point to coordinate OHEA- and
Agency-wide assessment of the human health and risk issues.
The Toxics Integration Branch (TIB) in the Office of
Emergency and Remedial Response (OERR) will work with the
TSP project manager to establish and monitor the conduct and
performance of the Center.
III. Scope of Responsibility
This MOU covers the specific tasks and functions to be
conducted by ECAO-Cin as a TSC for the Superfund program.
Risk assessments are used to determine baseline risk
and remedial alternatives and contribute to development of
cleanup levels at Superfund sites. They are performed by
many different contractors, and are reviewed in the regional
offices for adherence to program guidance and consistency of
approach. Those reviewers, with various levels of program
experience, are required to evaluate the contractor's
performance on calculating and characterizing risks from
chemicals and chemical mixtures. There may be data gaps
associated with these chemicals regarding their toxicities,
chemical interactions, exposure uncertainties, extrapolation
methods, and the use of default values in various parts of
the rioX assessment process. There are stages during the
procM^ where expert judgment is necessary, and there are
roany-*rea» where inconsistency can occur.
It is important to'the Superfund program that the
regions, contractors and potentially responsible parties
(PRPs) use a consistent process to characterize risk; and
--that- selection of remedies to meet a health-based cleanup
level for a specific chemical is reasonably comparable
across regions. Toward that end, the program has updated
the guidance on Superfund human health evaluation, has added
checklist and reporting format to the guidance, and has been
-------
working with ORD and other offices to develop policy and
guidance on exposure scenarios or risk assessment procedures
for certain chemical classes. Despite these efforts, the
Superfund program does not always have the most current
information concerning the state-of-the-science on risk
assessment methodologies, chemical-specific toxicity values
or characteristics, or the status of review or assessment
for Superfund priority chemicals.
The Superfund program is proposing that ORD designate
ECAO-Cin as a TSC on health risk assessment to respond to
the needs of Superfund regional and headquarters staff.
ECAO-Cin has a long history of providing support to
different regulatory programs, has experience on chemical
review and toxicity validation, and has an excellent working
relationships with other ORD labs and program offices; all
of these are critical elements for the success of the TSC.
In addition to the proposal for establishment of a TSC
in ECAO-Cin, TIB/OERR will work with the regions to
formalize a regional risk assessment forum as an integral
part of coordinating technical support and assistance
through all TSCs. All requests for technical assistance
should be funneled through appropriate regional forum
representatives. Forum representatives from every region
will also participate in regularly scheduled teleconferences
with TIB staff and representatives to TSCs to ensure that
consistent approaches are applied across all the NPL sites
and to identify any issues for which policies or
recommendations need to be developed.
A. Functions of the TSC
Generic categories of functions of the TSC for health
risk assessment are as follows:
1. To provide direct client services on a rapid turnaround
basis by use of available in-house expertise to
minimize additional referrals. At a minimum, the TSC
should be able to access most data bases and quickly
assemble a panel of risk assessment experts to meet a
particular need.
2. Where such expertise is not available [e.g., air
toxics, radiation, structure activity relationship
(SAR) review], the TSC oust be able to work with the
project manager, regional forum representatives, ORD
Office of Technology Transfer and Regional Support
(OTTRS), and other program offices (for example,
. - AirRisc at OAQPS and Chemical Assessment Desk at OTS)
to have the service delivered when needed.
-------
3. To coordinate with other TSCs to provide a "total
response" to the extent feasible, using direct referral
when appropriate. This includes assuming lead
responsibility for integrating responses to
multi-facted questions, as well as referrals to other
TSCs when appropriate.
4. To work with the TIB staff and TSP project managers in
conducting regularly scheduled forum teleconferences,
in holding periodic meetings (to review activities,
issues, major requests, etc.,) and in distributing
minutes of such events.
5. To document inquiries (and responses to those
inquiries) to enable the TIB to identify long-term
research needs.
6. To coordinate with CERI, OTTRS, or other offices in the
preparation, publication and distribution of technical
updates, summaries, and other information used in risk
assessment.
7. To articulate Superfund priorities in ORD so that
chemical-specific information needed for risk
assessment (e.g., inhalation reference doses or slope
factors) will be developed for interim and final
usages.
B. Specific Tasks
The following list is not at all inclusive, but does
provide a good overview of the functions and
responsibilities of the TSC for health risk assessment:
1. Provide rapid response by telephone and written follow-
up when appropriate to regional toxics integration
coordinators, RPMs, OSCs, and regional Superfund staff
relating to chemical-specific health information
[worker protection and protective clothing questions
are to be addressed jointly with ERT.] Obtain
background information about the site, provide answers
rather than making referrals, as appropriate, and
inform the regional Superfund staff regarding the
response provided to the requestor.
2. Work with TIB in providing interpretations and
clarifications regarding questions on the Risk
Assessment Guidance for Superfund (RAGS): Human Health
Evaluation Manual. Also to develop interim or default
recommendations or rationale on issues applicable to
risk assessment for Superfund sites (for example,
route-to-route extrapolation, interim RfDs and dermal
risk parameters).
-------
3. Develop, working with TIB and other OERR staff as
appropriate, site-specific, medium-specific and health-
based trigger or cleanup levels for a contaminant, or
help the Regions to justify the use of a surrogate
cleanup level based on risk to human health (for all
phases of Superfund Programs, such as removal and
remedial programs).
4. Help TIB/OERR to compile periodic updates and notices
of refinements for risk assessment methodology for the
Superfund Program, to be distributed to users of RAGS.
Also assist TIB/OERR in providing training tools for
Regional Superfund staff in order to ensure consistency
and to improve the quality of all Superfund risk
assessment.
5. Provide periodic status reports regarding TSC activities
to TIB/OERR. Help identify and plan future research to
address issues related to the Superfund Program.
Assist TIB/OERR in coordination with other TSCs to
better utilize the existing expertise and resources.
6. Work with other TSCs on analysis of issues, such as the
characterization of risidual risks or risks posed by
cleanup technology.
7. Provide review and comment on site-specific Superfund
risk assessments or risk assessment methods.
IV. Period of Agreement
This MOU will continue in effect until modified or
amended by the concurrence of both parties or terminated by
either party upon a 30-day advance written notice of the
other party. Nothing in the memorandum is intended to
diminish or otherwise alter authority of the offices
involved.
V. Amendments
The memorandummay be amended at any time by the
agreement of both parties. Each amendment must be in
writing and signed by the appropriate ORD and OSWER
officials.
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
'•IB 23 .:.-
3C:.'D
i\0 iV?
INTERPRETATION OF TEXT IN MEMORANDUM OF UNDERSTANDING ESTABLISHING
TECHNICAL SUPPORT CENTER FOR HUMAN HEALTH RISK ASSESSMENT
Although the last paragraph under II. Authority of the
Memorandum of Understanding identifies ECAO-Cin as the focal
point to coordinate OHEA- and Agency-vide assessment of human
health risk issues, there is need for more explicit understanding
of the role of other Office of Health and Environmental
Assessment (OHEA) entities.
Our expectation is that ECAO-Cin will continue to work with
and refer appropriate inquiries to the Exposure Assessment Group
(EAG) and Human Health Assessment Group of OHEA and ECAO-RTP.
Typically ECAO-Cin would coordinate as needed with HHAG and ECAO-
RTP on toxicity issues and consult with or delegate questions on
exposure assessment to EAG. EAG would serve as primary resource
on topics addressed in Chapters 4, 5, and 6, "Data Collection",
"Data Evaluation" and Exposure Assessment" of Risk Assessment
Guidance for Suoerfund; Human Health Evaluation Manual.
William H. Farland, Ph.D.
Director
Office of Health and
Environmental Assessment
Larry G. Reed
Acting Director
Hazardous Site Evaluation Div.
-------
f
VI. Effective Date
This memorandum will become effective at noon on the
date of the last signature below.
Erich w. Bretthauer />~Don R- Clay
Acting Assistant Administrator /"(Assistant Administrator for
for Research and Development ^ Solid Waste and Emergency
*. I, f*n Response
Date: ^/O I rO Date:
------- |