November 2016
Standard Operating Procedure
(SOP) for Selecting and
Prioritizing Chemicals for
PPRTV Development

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CONTENTS
PPRTV SCOPING TEAM	iii
ACRONYM DESCRIPTIONS	iv
1.	STANDARD OPERATING PROCEDURE (SOP) FOR CANDIDATE SELECTION AND
PRIORITIZING CHEMICALS FOR PPRTV DEVELOPMENT	1
2.	STANDARD ANNUAL PROCEDURE	1
3.	FAST TRACK PROCEDURE	3
4.	REPORTING	3

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PPRTV SCOPING TEAM
Title
Staff Members
STSC ADMINITRATIVE DIRECTOR
Teresa Shannon
STSC CO-DIRECTORS
Phillip Kaiser and Beth Owens
NCEA BRAB & CRAB BRANCH CHIEFs
Jason Lambert
Belinda Hawkins
NCEA CINCINNATI DIVISION DIRECTOR
Annette Gatchett
OSRTI SPB BRANCH CHIEF
Mike Scozzafava
OLEM HQ OH2R2AF TOXICITY WORKGROUP CO-CHAIRS
Michele Burgess
Keith Fusinski
OLEM SENIOR SCIENCE ADVISOR
Kathleen Raffaele

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ACRONYM DESCRIPTIONS
IRIS
Integrated Risk Information System. IRIS assessments cover hazard
identification and dose response steps of risk assessment. The assessment
may cover one chemical, a group of structurally or toxicologically related
chemicals or a chemical mixture.
NCEA
National Center for Environmental Assessment. NCEA is within the United
States Environmental Protection Agency's (EPA) Office of Research and
Development (ORD). The three main NCEA divisions are in located in
Cincinnati, OH, Washington, DC, and Research Triangle Park, NC. The STSC
and ERASC are led out of NCEA-Cincinnati.
PPRTV
Provisional Peer-Reviewed Toxicity Value. PPRTVs are toxicity values derived
for use in the Superfund Program. PPRTVs are derived after a review of the
relevant scientific literature using established Agency guidance on human health
toxicity value derivations.
OH2R2AF
TOXICITY
WORKGROUP
OLEM Human Health Regional Risk Assessors Forum Toxicity Workgroup. The
OH2R2AF Toxicity Workgroup is a sub-workgroup of the OLEM Human
Health Regional Risk Assessors Forum that is managed out of the Office of
Superfund Remediation and Technology Innovation. The mission is to
identify issues with respect to the use and reporting of toxicity values for
regional risk assessors; to provide technical direction in the selection of
toxicity values for OLEM programs.
OLEM
Office of Land and Emergency Management. OLEM provides policy,
guidance and direction for the Agency's emergency response and waste
programs; develops guidelines for the disposal of hazardous waste and
underground storage tanks; provide technical assistance to all levels of
government to establish safe practices in waste management; administer
the Brownfield's program which supports state and local governments in
redeveloping and reusing potentially contaminated sites; manage the
Superfund program, which responds to abandoned and active hazardous
waste sites and accidental chemical releases; and encourages innovative
technologies to address contaminated soil and groundwater.
QUARTERLY Quarterly reports are completed for each of the two technical support
REPORT	centers for which the HHRA program has main responsibility: the Superfund
Health Risk Technical Support Center (STSC) and the Ecological Risk
Assessment Support Center (ERASC). Reports from the STSC and ERASC are
developed and integrated into one master quarterly report covering the
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activities of all five of the ORD technical support centers. The reports serve
as an important resource to keep OLEM and regional risk assessors apprised
of activities, developments, and applications with respect to assessments
and other technical advice and evaluation. As such they aid efficiency,
consistency and communication of assessment information.
STSC	Superfund Health Risk Technical Support Center. STSC provides technical
support to EPA program (i.e, OLEM) and regional offices in the area of
Superfund human health risk assessment. Examples include the
development of Provisional Peer-Reviewed Toxicity Value (PPRTV)
assessments, scientific consultations, and support for interpreting EPA
publications and other guidance, and risk assessment methods research on
chemical pollutants.
TECHNICAL	A network of Regional forums and specialized Technical Support Centers
SUPPORT	(TSCs) providing technical assistance to Regional Remedial Project Managers,
CENTERS	Corrective Action Staff, and On-Scene Coordinators.
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1. STANDARD OPERATING PROCEDURE (SOP) FOR CANDIDATE SELECTION AND
PRIORITIZING CHEMICALS FOR PPRTV DEVELOPMENT
Representatives from the STSC, OLEM and the OH2R2AF Toxicity Workgroup will form a PPRTV
Scoping Team that will collaborate to nominate, select a candidate chemical list, and prioritize
the chemicals for PPRTV development on an annual basis. The goals of selecting and
prioritizing the chemicals requested for PPRTV development are twofold: (1) emphasize
development of high-quality deliverables based on the most current OLEM and Regional
priorities/needs; and (2) optimize the expenditure of fiscal resources and human capital for
assessment activities related to priority chemicals.
Two processes will be described in this SOP. The first is the standard annual nomination and
selection procedure. The second is for an emergency request for an accelerated addition of a
chemical for development. The annual prioritized list of chemicals will be released by June to
all parties listed as the Scoping Team for the upcoming fiscal year. Discussions on changes will
be conducted with the Scoping Team and after consensus by all parties will be distributed to
OLEM and OH2R2AF. Distribution will occur quarterly during the calls with OLEM and OH2R2AF
and documented in the recorded notes.
2. STANDARD ANNUAL PROCEDURE
A step-by-step process is used to compile chemicals of interest, narrow down, and prioritize
candidate chemicals for new PPRTV development as well as chemicals eligible for updating an
existing PPRTV (on a 5-year cycle). The steps are as follows:
1.	Nomination Forms:
In January of each year OLEM, the Lead Region for Superfund, and STSC will be asked to
prepare nomination forms for PPRTV assessments. Each nominated chemical should be
accompanied by a short description of the need for a PPRTV assessment. For example,
found at several Superfund sites, or is potentially a major source of exposure to a
population of interest. The nomination form is attached as Attachment 1. All forms
should be submitted to the STSC by January 30.
Prior to Step 2, all nominated chemicals that are on the IRIS agenda, or update, will be
removed. In addition, each nominated chemical will be evaluated considering current
resources (i.e., what can be done given the budget and available staff).
2.	Candidate Chemical Selection and Prioritization:
Annually the PPRTV Scoping Team (consisting of representatives from the STSC, OLEM
and the OH2R2AF Toxicity Workgroup) will review chemical nomination forms
(Attachment 1). Nominated chemicals will have an initial scoping and preliminary
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literature search to determine the potential to support a PPRTV derivation. Using
information from this initial scoping and preliminary literature search as well as
information from the nomination forms, the Scoping Team will evaluate the requested
chemicals based on the following set of criteria (Attachment 2):
	Number of Superfund sites with the chemical and concentrations.
	Number of times a PPRTV for that chemical was requested through the STSC
within the past 5 years.
	Data to support development of values (PPRTV and\or Screening Values). If a
chemical's data set is considered unlikely to support PPRTV derivation, it would
become an Appendix Screening Value candidate. If data are not available to
support PPRTV or Screening Value (e.g., read-across based surrogates)
derivation, another chemical from the candidate list would be selected for the
PPRTV agenda.
	PPRTV Update Request.
3. PPRTV updates:
In addition, all currently available PPRTVs will be reviewed to determine eligibility for
update (i.e., >5 years old). Selection criteria for update action are the same as under
the chemical selection process outlined above under 2.
The schedule for the nomination and selection process is as follows:
	Call for nominations	January (30 days)
	Perform initial scoping and preliminary	February\March
literature search
	Scoping Team Selection and Prioritization March\April (adjust assessment
agenda as needed)
	OLEM and NCEA management review and May
approve list
	Release the Final Chemical List to OLEM June
and Chairs of the OH2R2AF Toxicity
Workgroup
	Initiate work on list	June
Steps in the process are as follows:
A.	A nominated chemical list is developed by the STSC from the call for chemical
nominations, including the nominations compiled by the STSC from the hotline.
This will include information on the need and who requested the chemical.
B.	After consideration of current resources, an initial scoping and preliminary
literature search is performed for the list of nominated chemicals.
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C.	Chemicals are screened for data and information. The Scoping Team reviews the
information on the chemicals and prioritizes based on the chemical prioritization
criteria outlined above.
D.	OLEM and NCEA review and approve list.
E.	The final list is released to OLEM and Chairs of the OH2R2AF Toxicity Workgroup.
If a chemical did not make the Final Chemical List the Regional requestor will be
notified by the Scoping Team with the rational for non-selection.
F.	Work begins.
3. FAST TRACK PROCEDURE
If an "Fast Track" need is raised by a Region outside of the normal annual nomination,
candidate chemical selection, and prioritization process the following steps will be followed:
1.	Formal request for support must be submitted to the STSC Hotline or OLEM.
2.	The STSC will immediately raise the request to OLEM HQ and the OH2R2AF Toxicity
Workgroup for review and consideration. Emergency requests for PPRTV development
will go through the same criteria as described under steps 1 and 2 of the annual
procedure above. Additionally, consideration for PPRTV development will include
discussions on: (1) which chemical(s) in the selected/prioritized list for that given FY will
be postponed; (2) specialized expertise needs; and (3) size of the chemical's data base
and resource needs.
3.	Decisions and outcomes based upon "fast track" deliberations among the groups listed
above, after consensus by OLEM and NCEA management, will be drafted and
transmitted in a memo from OLEM to all relevant stakeholders (e.g., OH2R2AF Toxicity
Workgroup, STSC, and original requesting office). This memo may include but is not
limited to: (1) PPRTV document development decision(s); (2) anticipated timeline(s) for
chemical(s) added to the prioritized list, and/or (3) referral to the IRIS Program, ATSDR,
etc.
4. REPORTING
Regular communication with OLEM and the Regions (through the OH2R2AF Toxicity Workgroup)
will be through monthly or bi-monthly calls. Once the Final Chemical List is determined and
approved by OLEM and NCEA management, it will be disseminated to OLEM and Chairs of the
OH2R2AF Toxicity Workgroup. Regular updates will occur on the monthly calls. Any changes, or
consideration for changes, in the chemical list will be noted on those calls.
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Selected candidate and prioritized chemicals are subject to change based on the following
factors:
	Based on initial literature search no animal or human data are found and the surrogate
approach is not applicable.
	The literature search reveals that the scope of the document would be more than
double the contract hours to develop and/or human resources necessary to complete
the document. This would diminish the amount of resources available to complete the
annual goal.
	A fast track chemical has been added to the list.
Any changes to the prioritization list will be coordinated by OSRTI Science Policy Branch Chief
and NCEA Division Director prior to implementation.
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