| Acute Exposure Guidelines Levels (AEGL) Program Support |
| Program Summary |
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| Description |
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Last Updated: | | 02/07/2008 |
Record Number: | | FY 08 - 092 |
Procurement Title: | | Acute Exposure Guidelines Levels (AEGL) Program Support |
Description of Acquisition: | | Acute Exposure Guidelines Levels (AEGL) Program Support |
Procurement Office: | | Headquarters Procurement Operations Division (HPOD) |
End User by AAship or Region: | | Office of Prevention Pesticides and Toxic Substances (OPPTS) |
End User by Program Office,
Division or Laboratory: | | OPPT/RAD |
NAICS Code: | | TBD |
NAICS Code Title: | | |
NAICS Code Size Standard: | | |
Contract Type: | | Cost Plus Fixed Fee |
Procurement Method: | | Sources Sought Will Determine Procurement Method
To Be Decided After Market Research |
Estimated Dollar Range: | | >$5M - $10M |
Place of Performance: | | Contractor's Facilities, Government Facilities, Travel |
Solicitation Issue Date (by Quarter): | | FY 2008 - Q3 |
Target Award Date (by Quarter): | | FY 2008 - Q4 |
EPA Contact: | | Robert M. Minjack |
E-Mail: | | minjack.robert@epa.gov |
Telephone: | | (202) 564-4794 |
Other Procurement Information: | | This work is currently being done through an Inter-Agency Agreement (IAG) with Department of Energy by the Oak Ridge National Laboratories (ORNL) a Federally Funded Research and Development Center (FFRDC) |
Status: | | Waiting for Market Research |
Award Information:
Company Name & Date: | |
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Contract Award Number: | | |
Statement of Work (Attachment(s) or Internet Link)
STATEMENT OF WORK
Title: Develop, present, revise Acute Exposure Guideline Levels (AEGL) Technical Support Documents and provide technical and administrative support to the AEGL Program.
I. Background
SHORT DESCRIPTION OF AEGL PROGRAM:
The Acute Exposure Guideline Levels (AEGL) Program develops key information for emergency planners and responders in identifying and assessing the risks associated with accidental and terrorist release of extremely hazardous substances. The AEGL program provides critical support to Homeland Security risk assessment activities. Final values are published by the NAS.
REASON FOR PROGRAM:
The accidental release of methyl isocyanate in Bhopal, India in December of 1984 and the massive loss of life sharply focused the world on the need for planning to prevent industrial chemical accidents and emergency response measures should a chemical release occur. Further, the September 11 attacks raised the specter of deliberate release of toxic chemicals from terrorist acts. A critical component to emergency planning and response needs is scientifically credible information on the hazardous and safe levels of inhaled chemicals for single episodes of exposure. These values are required by local communities, states, various federal agencies, industry and the international community. Of great importance is the development of one set of credible values in order to minimize confusion in the planning/response community and to maximize the cost effectiveness of the development of these values.
To address this need the Acute Exposure Guideline Levels (AEGL) Program was instituted to develop inhalation acute exposure values for detection, disability, and death for exposure durations between 10 minutes and 8 hours.
Stakeholders (federal government agencies, states, private sector, international community) for this critical need were consulted and two formal lists of chemicals with a total of 470 chemicals of concern were developed. An additional 8 chemicals were added because of requests by stakeholders. This list has been revised to approximately 335 chemicals. The AEGL Program remains committed to responding to the needs of stakeholders and may add chemicals when requested. As of the end of FY-07, the AEGL Program had developed AEGL values for 218 chemicals which are in Proposed, Interim, or Final status and an additional 17 were examined but AEGL values were not derived because of a lack of data.
The AEGL Program is currently in the process of assessing the priority for developing AEGL values for chemicals on the list.
HOW AEGLs ARE DERIVED:
The AEGL Program develops AEGL values through a process which ensures scientific credibility and input from the stakeholders. The majority of the funding for the program funds the development of Technical Support Documents (TSDs). AEGL values go through 4 stages (draft, proposed, interim, and final).
The AEGL Program develops AEGL values on a chemical-by-chemical basis. Relevant data and information are gathered from all known sources including published scientific literature, state and federal agency publications, private industry, public data bases and individual experts in both the public and private sectors. All key data and information are summarized for the NAC/AEGL Committee (see below) in Draft form. Both the Draft AEGL values and Draft technical support documents are reviewed by the NAC/AEGL Committee members and revised as necessary prior to formal committee meetings.
A major component of stakeholder involvement and scientific review comes from the National Advisory Committee for Acute Exposure Guideline Levels (NAC/AEGL Committee). This is a Federal Advisory Committee (FACA) which is sponsored by EPA with an OPPT lead. It serves as a major vehicle for ensuring scientific credibility and acceptance by stakeholders within the United States and internationally since they are members of the Committee. Currently the NAC/AEGL Committee meets four times a year and deliberates over the Draft AEGL TSDs. After approval by the NAC/AEGL Committee the AEGL values are raised to Proposed status.
A notice that Proposed AEGLs are available for public comment is published in the Federal Register. After responding to public comments the NAC/AEGL Committee raises the AEGL values to Interim status.
Interim chemicals are sent to a National Academies (NAS) Committee on Toxicology review committee constituted to review AEGLs. After documents are reviewed, revised and approved they are published by the National Academy Press as Final values.
This comprehensive development and review process assures the highest standards of scientific credibility, maximal input and acceptance by stakeholders and eliminates duplication of effort and conflicting sets of standards by different stakeholders. By pooling personnel and monetary costs in one program the AEGL Program ensures the most efficient expenditure of limited public funds.
II. Technical Requirements
All work products developed from this work is the property of the United States government. Copyright belongs to the United States government.
STATEMENT OF WORK-AEGL PROGRAM
The Statement of Work provides broad areas of tasks to be accomplished under subsequent Technical Direction by the Project Officer. The initial funding will be for Task 1 below and after approval the remaining activities will be initiated.
1. Develop a written Quality Management and Quality Assurance Plan, which complies with the requirements of NASI/ASQC E-4. The plan will be submitted to EPA for approval before any environmental data activity begins.
2. Prepare Technical Support Documents (TSDs) on assigned chemicals to support the development of Acute Exposure Guideline Levels following procedures laid out in NRC, 2001.
a. Conduct literature research and retrieve relevant studies as specified in NRC,2001 Section 2.3 referenced below Guidelines and criteria for the search strategy, evaluation, selection, and documentation of key data and supporting data used for the derivation of AEGL values. Contractor shall maintain studies used in the development of the Technical Support Documents. Adobe acrobat pdf files shall be delivered to the EPA COR on a CD. Key study pdf files will be searchable.
b. For each assigned chemical the contractor shall complete an AEGL Technical Support Document (TSD) using the methodologies and format detailed in NRC, 2001. This will include appropriate summaries of studies reviewed and will comprise an in-depth examination of the materials and methods employed, reported results, scientific assessment of the study, a description of conclusions that summarize the overall significance of the study discussing as appropriate dose levels, no observable adverse effects levels (NOAEL), lowest observable adverse effects levels (LOAEL), reliability of the study and significant toxicological effects. The review and evaluation of each study will include review and analysis of all necessary graphic displays of data, summary tables, and references needed to substantiate technical detail supporting the reviewer's conclusions. Toxicity data for the chemical and AEGL values shall be plotted graphically as described in NRC, 2001.
The TSD shall evaluate studies, select studies and endpoints on which to base toxicity, evaluate plausible modes of action and commonalities for cancer and noncancer endpoints, and perform quantitative dose-response assessments using state-of-the-art methodologies (including benchmark dose modeling, dosimetry estimations, duration scaling estimations and PBPK analysis where appropriate). Development of these documents will require theoretical and/or empirical approaches and expert scientific judgment. Where appropriate, derive cancer risk assessments as detailed in NRC, 2001. All AEGL values derived in TSDs shall be fully supported by scientific rationales as described in NRC, 2001!
c. As specified in NRC, 2001, the contractor shall interact with the National Advisory Committee for Acute Exposure Guideline Levels (NAC/AEGL Committee) AEGL Development Team headed by the Chemical Manager to incorporate comments of the team.
d. The contractor shall present the TSD to the NAC/AEGL Committee at a scheduled meeting. The presentation shall include description of the key studies and rationales used to derive AEGL values. Emphasis shall be placed on the scientific reasoning and support for the rationales used. Materials used to develop the TSD shall be present at the meetings for examination by the committee as needed.
e. Summarize comments on AEGL derivations at all stages of the review process
including public comments on Proposed AEGL values and National Academies (NAS) review. Prepare responses to comments and revise the Technical Support Documents as needed to respond to the comments.
f. The contractor shall present the TSD to the National Academies (NAS) Review Committee at a scheduled meeting. The presentation shall include description of the key studies and rationales used to derive AEGL values. Emphasis shall be placed on the scientific reasoning and support for the rationales used. Materials used to develop the TSD shall be present at the meetings for examination by the committee as needed.
g. Provide technical editing of TSD documents. Technical editing may include editing of the document to ensure correct grammar, spelling, punctuation, usage, and appearance of tables and figures; cross-checking references, page numbers, tables of contents, and the like to ensure consistency, checking for correct formatting in conformance with the AEGL SOPs and templates; and other details of style. It may also include substantive editing including rewriting or rearranging sentences, paragraphs, or sections; arranging or rearranging tabular material; redrawing and retouching illustrations; standardizing symbols; checking and standardizing equations, and checking numbers in the text against figures and tables to insure consistency.
3. Provide technical support for communication with interested parties, organizations and the general public through such means as the Federal Register, Internet, etc. Maintain a website for access to key documents for the use of the NAC/AEGL and NAS committees.
4. Conduct workshops or other technical ad hoc meetings or provide technical support at meetings related to the development of AEGL values including preparation of workshop materials, logistical meeting support, and summary of meeting decisions and outcomes.
5. The contractor shall develop analyses, white papers or toxicological reviews of specific health assessment topics. Specific tasks may include research, development and support of methods to improve risk assessment and reduce the uncertainty in the risk assessment approaches for cancer and noncancer toxic endpoints.
To conduct these complex analyses, the contractor shall identify expert scientists in the required scientific disciplines, convene work groups or meetings to conduct coordinated reviews, conduct the workgroup or meetings, and prepare draft reports. The proposed scientific and technical authors shall be recognized nationally or internationally in their field and have both a general knowledge, as well as the specific knowledge, expertise or experience as specified in the work assignment. During the development of the documents or issue papers, the contractor may be required to meet with EPA and/or the document authors to discuss the document. Subjects of documents or issue papers vary widely and will be defined specifically by the TO.
Examples include, but are not limited to, the following:
a. Develop improved understanding of physiological and biochemical processes and relate this knowledge to conventional EPA or other default approaches
b. Improve risk assessment default approaches using physiological, mechanistic information, human and animal molecular biomarker data and conventional toxicological data
c. Develop methods and perform route to route extrapolations for adverse effect indices.
d. Evaluate plausible modes of action and commonalities for cancer and noncancer endpoints.
e. Development and/or refinement of mathematical/biological/chemical/physical methods/models [e.g., dose-response modeling techniques such as benchmark dose, categorical regression, pharmacokinetics and pharmacodynamic models, or biologically based dose response (BBDR) models, PBPK models]
f. Analysis of AEGL TSDs to establish recurring analyses.
6. Information Management:
The Contractor shall provide support for data collection and compilation activities
pertaining to all support of the AEGL Program. Data extracted will be transcribed to a conveniently-accessible format. Such formats will include off-the-shelf relational data bases, spreadsheets, or word-processing software. This task may involve data evaluation, analysis, and transformation, as necessary for the particular application. The Contractor may also be required to reevaluate, update, document, and otherwise maintain existing or new information systems so developed.
7. Specific guidance for identifying and evaluating data, establishing minimum or no-effect levels, making interspecies and intraspecies adjustments and time-scaling the AEGL values can be found in the NAC/AEGL Committee's SOP Manual. This manual also includes specific guidance for the format and content of the TSD, the development of the scientific rationale for data selection and manipulation, and the calculations of risk based on acute exposure to acutely toxic chemicals and carcinogenic agents.
8. Meetings may be held in other countries. The contractor shall provide technical support and shall travel to international meetings to support the AEGL Program as directed.
III. References
NRC (National Research Council). 2001. Standing operating procedures for developing acute exposure guideline levels for hazardous chemicals. Committee on Toxicology, Board on Toxicology and Environmental Health Hazards, Commission on Life Sciences, National Research Council. National Academy Press, Washington, DC.
http://www.epa.gov/oppt/aegl/pubs/sop.htm |
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