A Federal Advisory Committee for the U.S. Environme ntal Protection Agency’s Office of Research and Dev elopment 

### Summary of the

44th EXECUTIVE COMMITTEE FACE-TO-FACE MEETING

Western Ecology Division

National Health and Environmental Effects Research Laboratory

U.S. Environmental Protection Agency

Corvallis, OR

July 12-13, 2010



### M ONDAY 

### , J ULY 

### 12, 2010

Welcome and Introductions Dr. Gary Sayler, University of Tennessee, BOSC Exec utive Committee Chair

Dr. Gary Sayler, Chair of the Executive Committee o f the Board of Scientific Counselors (BOSC), called the meeting to order at 9:03 a.m., and welcomed the BOSC members to the 44th face-to-face meeting of

the Executive Committee. He mentioned that the BOS C Executive Committee meets once each year at an EPA facility outside the Washington, DC, area, and this year Corvallis was selected. Dr. Sayler thank ed Dr. Tom Fontaine, Director of the Western Ecology D ivision (WED) of the National Health and Environmental Effects Research Laboratory (NHEERL), for hosting the meeting.

Dr. Fontaine welcomed the BOSC members to Corvallis and encouraged participants to take a copy of the booklet on WED, which was available on the handouts table. The booklet contains descriptions of the research being conducted by WED. He stated that th e meeting agenda includes two field tours during which some of the laboratory’s research will be pre sented to the BOSC. He mentioned that representatives from the Government Accounting Offi ce (GAO) were visiting WED and he would be dividing his time between the BOSC and GAO groups.

Dr. Sayler announced the presence of four new BOSC members—Drs. John Tharakan, Susan Cozzens, and Ken Olden, and Ms. Marie Zhuikov—and welcomed t hem to the Executive Committee. He pointed

out that two of the BOSC members—Drs. Dennis Pauste nbach and Katherine von Stackelberg were unable to attend the meeting, but Dr. von Stackelbe rg would be participating by telephone. Although h e was not present, Dr. Sayler mentioned that Dr. Henr y Falk was expected to arrive late (Dr. Falk, howev er, was unable to attend).

Review of April Teleconference Minutes

Dr. Sayler asked if there were any comments on the draft minutes for the April 1, 2010, conference cal l. When no comments were offered, Dr. Sayler called fo r a motion to approve the minutes. Dr. Barry Ryan moved to approve the minutes without any changes an d Dr. Ken Demerjian seconded the motion. The minutes for the April teleconference were approved unanimously by the BOSC.

Overview of Agenda

Dr. Sayler gave a brief overview of the meeting age nda. The morning of Day 1 included the remarks from the Designated Federal Officer (DFO) for the BOSC, the remarks of the Assistant Administrator forBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 2 Research and Development (AA/ORD), an overview of O RD’s chemical research realignment (Safer Products for a Sustainable World [SPSW]), presentat ion of the mid-cycle progress report for the Safe Pesticides/Safe Products (SP2) Research Program, an d the mid-cycle progress report for the Human Health Risk Assessment (HHRA) Research Program. Th e afternoon of Day 1 began with a session on ecosystem informatics, which included presentations on computer science approaches to species modeling and mathematics of ecological dispersion. This ses sion was followed by a 2-hour tour at the Corvallis facility. Day 2 began with a presentation of the OR D response to the BOSC Human Health Research Program Review Report. The morning also included a n update from ORD and a report on the status of the BOSC and Science Advisory Board (SAB) liaison, as well as time for public comment. Also on the agenda was a review of the methods and procedures u sed to identify and prioritize research needs at th e ORD Nanomaterial Case Study Workshop. The morning concluded with a discussion of future business. Following adjournment of the meeting, the BOSC Exec utive Committee met informally with GAO representatives and the afternoon concluded with a field study tour. Dr. Sayler asked if there were a ny questions or additions to the meeting agenda and th ere were none.



### BOSC DFO Remarks Mr. Greg Susanke, BOSC Designated Federal Officer, ORD, U.S. Environmental Protection Agency (EPA)

Mr. Susanke, the DFO for the BOSC Executive Committ ee, welcomed the BOSC members to the meeting and thanked them for their participation. He explained that the BOSC is a federal advisory committee that is subject to the requirements of th e Federal Advisory Committee Act (FACA). Mr. Susanke reviewed the procedures that are requir ed for all BOSC meetings. He stated that the BOSC provides independent, scientific peer review and ad vice to EPA’s ORD, and it is his responsibility as the DFO to ensure compliance with all FACA rules.

In compliance with FACA requirements, all BOSC meet ings are open to the public and time has been designated on the agenda for public comment. Mr. S usanke noted that although he received several requests for the agenda and materials, no requests for comment were received prior to the meeting. Ti me has been set aside on Tuesday’s agenda at 10:15 a.m . (PDT) for public comment. He asked that

comments be limited to 3 minutes each. An ORD cont ractor, Beverly Campbell from The Scientific Consulting Group (SCG), was present to take notes t hat capture the presentations and discussions. Following the meeting, she will prepare the meeting minutes, which will be made available to the publi c on the BOSC Web Site after approval by the Executiv e Committee and certification by the BOSC Chair.

As required by FACA, a notice of this meeting was p ublished in the Federal Register . Mr. Susanke established an electronic public docket for the mee ting on the Federal Docket Management System (FDMS), which can be accessed at http://www.regulations.gov . The number to search for this docket is EPA-HQ-ORD-2010-0532. The agenda was made availabl e to the public in the docket. Meeting materials are available upon request or they can be found on the BOSC internet site, http://www.epa.gov/osp/bosc . As the DFO, Mr. Susanke ensures that the Executi ve Committee members receive annual ethics training and complete confide ntial financial disclosure forms. He asked members to notify him immediately if any potential conflict of interest arose during the meeting deliberations, a nd he asked if any member had a potential conflict to dec lare. Regarding the session on the identification and prioritization of nanomaterials, Dr. Sayler said he would discuss his work with nanomaterials with the

DFO to determine if a conflict of interest or lack of impartiality exists.

Mr. Susanke reminded the BOSC members and other par ticipants to sign in at the registration desk if th ey had not done so already, and mentioned that Denise Hoffman from SCG was at the desk to help with any logistical needs.

Dr. Fred Hauchman said that he would be present for the entire meeting. He mentioned that Dr. Kevin Teichman, who usually attends the BOSC Executive Co mmittee meetings, would be presenting the ORDBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 3 Update via videoconference. He added that Dr. Paul Anastas, the AA/ORD, also would be providing his

remarks via videoconference. Dr. Hauchman stated t hat Dr. Anastas is keen on advancing the work of th e BOSC, and really appreciates the work of the Board on behalf of ORD.

Dr. Sayler explained to the new Executive Committee members that the BOSC’s role is to provide advice to ORD (not EPA). The BOSC is not the SAB; there a re distinct differences and the members should keep these in mind. He asked if any of the new mem bers would like to offer any comments.

Dr. Ken Olden said that it is important to him to k now that ORD is listening and responding to the adv ice offered by the BOSC. He has been impressed with ho w responsive ORD has been to the BOSC in the past and he hoped that would continue in the future . Dr. Sayler agreed that ORD has been very responsive to the BOSC’s comments, criticisms, and advice. The Board clearly has the opportunity to impact the long-term goals (LTGs) and directions of ORD’s research. He noted that the work of the Decision Analysis Workgroup is a good example of ho w the BOSC is impacting ORD’s programs.

Dr. Sayler stated that he hopes the BOSC can take o n some additional tasks now that the Board is no longer conducting mid-cycle program reviews. This c hange has reduced the number of cyclical reviews and should free up some time to address other topic s. Dr. Sayler mentioned that the meeting notebook contained a copy of Dr. Anastas’ “ORD: The Path For ward” memorandum.

Dr. Sayler asked those joining the meeting via vide oconference and telephone to identify themselves. When Dr. Anastas joined the meeting via videoconfer ence, Dr. Sayler asked the BOSC members to

introduce themselves. The Board members and other participants are included in the list of participan ts attached to this meeting summary.



### AA/ORD Remarks Dr. Paul Anastas, Assistant Administrator for Resea rch and Development, ORD, EPA

Dr. Anastas greeted the BOSC members and offered a specific welcome to the new members of the Executive Committee. He apologized for not being a ble to attend the meeting in person, and explained that he had been spending a great deal of time in t he Gulf and would be going down there later in the

week. Dr. Anastas said he wanted to focus on some of the big issues being addressed by ORD since the last BOSC meeting. The major one is the response t o the BP oil spill in the Gulf of Mexico. ORD has a diverse range of programs and capabilities, and the Agency’s response to the oil spill has tapped into every part of ORD. Dr. Anastas said he was very pr oud of ORD’s efforts; the staff has been putting in long hours and a great deal of effort on this respo nse. He noted that the BOSC would be hearing more on ORD’s involvement in the oil spill response from Mr . Lek Kadeli on Tuesday. Dr. Anastas also mentioned some recent stories in the press that que stioned the scientific integrity of the Administrat ion and EPA. He took exception to these stories and st ressed the importance of confronting such stories quickly to dispel any misconceptions.

Referring to his “Path Forward” memo that was issue d a few months ago, Dr. Anastas stated that one of his priority areas for ORD is to work closer with i ts program and regional partners; ORD is taking ste ps to engage these partners in time for the 2012 ORD rese arch program planning. Another goal is to ensure that ORD’s work is not fragmented and is conducted using a systems approach. ORD will be engaging in Integrated Transdisciplinary Research (ITR), which is defined as the process to develop sustainable solutions to environmental problems by engaging par tners who transcend traditional scientific discipli nes throughout each stage of the research process. Dr. Anastas also will be encouraging the development o f sustainable technological innovations. He said he was meeting later that day with the EPA Administrat or to discuss how to keep the Agency at the cutting ed ge of innovation and how to better communicate the impact of EPA’s work. The Agency will need to make adjustments on how it aligns the budgetary structure to facilitate the flexibility needed to a chieve these goals. ORD will be initiating a “seed grants” program that encourages high-risk proposals for cat alyzing innovation and sustainable solutions. Thes eBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 4 grants will allow investigators to prove the concep t on a small scale, and those that are successful c an apply for additional funding to continue their effo rts.

ORD will build the goals of sustainability into its grant solicitations, so that ORD is funding resear ch that

leads to sustainable solutions. ORD also is launch ing an impact initiative to improve the communicati on of how its research is impacting public health and the environment. Few of ORD’s successes are widely known and that is impairing ORD’s ability to have a greater impact. ORD is working to collect and translate the results of its research, so that they can be communicated to stakeholders, the general p ublic, and decision makers on Capitol Hill and elsewhere. He noted that ORD has not invested enough effort i n this area in the past.

Dr. Anastas said that he had asked the Laboratory a nd Center Directors to dedicate time to the implementation and institutionalization of the “Pat h Forward” goals. A group known as the Delta Team has been formed to develop action plans to implemen t and institutionalize these goals. Dr. Anastas me ets with this group frequently, and he expects the acti on plans to be completed by the end of July 2010.

Dr. Anastas asked if there were any questions from the BOSC members.

Dr. Olden said he was very impressed with Dr. Anast as’ presentation, particularly the move to Integrat ed Transdisciplinary Research. He asked if ORD was co nsidering a reorganization that would focus on problems rather than disciplines. Dr. Anastas repl ied that this exercise is not about a reorganizatio n, rather it is a reorientation of ORD thinking. ITR will reorient the way ORD defines and implements approaches. Dr. Olden supported the increased emph asis on communicating the impact of ORD’s research. He noted that the Agency’s science is ou tstanding but often is poorly communicated.

Dr. Martin Philbert complimented Dr. Anastas’ prese ntation and asked about ORD’s role in integrating with other “sister” agencies working on the BP oil spill. Dr. Anastas responded that there are 18 dif ferent agencies involved in the response, and the Coast Gu ard has the lead. EPA is very involved and has bee n at the table for all the discussions. EPA will be meeting with the National Oceanic and Atmospheric Administration (NOAA) on July 19, 2010, to exchange data. Dr. Anastas pointed out that, as this moves from an emergency response to a recovery and restor ation operation, access to scientific and technical input in real time will be required. EPA is workin g with other agencies to develop longer-term plans to provide this support. The Agency is fully aware th at the crisis does not end when the oil stops flowi ng, and ORD is preparing to meet the future challenges.

Dr. Philbert asked if there is a coordinated attemp t to collect meaningful data while the oil is flowi ng. Once the flow of oil is stopped, these data will be used to assess the human health and ecological imp acts over time. Dr. Anastas replied that all the data c ollected are being consolidated on a unified intera gency Website. The agencies have coordinated on the type and breadth of data that need to be collected, and they are sharing and centralizing these data. EPA is working with one of the health agencies on an initiative to make the critical linkage between env ironmental and health impacts. The Agency also is in discussions with natural resource agencies and NOAA regarding the follow-on efforts. He reminded the BOSC members that they will be hearing more on EPA’ s involvement in the oil spill response from Mr. Kadeli on Tuesday morning.

Dr. Sayler asked about the role the BOSC could play with respect to ITR. Can the BOSC offer ORD advice on how to implement it? Dr. Anastas respond ed that one particular area on which he is eager to obtain input from the BOSC is how to translate sust ainability into the operational framework and then

into research that affects the fundamental mission of the Agency.

Dr. Sayler asked if there were any more questions f or Dr. Anastas, and when there were none, he thanke d Dr. Anastas for his presentation and for taking the time to respond to the BOSC’s questions.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 5 Overview of ORD Chemical Research Realignment: Saf er Products for a Sustainable

World Dr. Elaine Francis, National Program Director, Safe Pesticides/Safe Products Research Program, ORD,

EPA

Dr. Elaine Francis mentioned that many of the colle agues with whom she worked to develop the framework for this realigned program were from Rese arch Triangle Park, North Carolina, and Ada, Oklahoma, and they were participating by videoconfe rence or telephone. She explained that today’s presentation was merely an overview; more informati on on the program will be presented at the next BOSC Executive Committee meeting and ORD hopes to e ngage the BOSC in a dialogue about the program at that time.

A number of the research plans that are being incor porated into this new program are some of those tha t will be reporting to the BOSC at this meeting (e.g. , SP2, Human Health). That is the primary reason t hat this briefing was included on today’s agenda. She noted that ITR, which was described by Dr. Anastas, captures the essence of what ORD is trying to do wi th this new program. The research will be directed to finding sustainable solutions to environmental prob lems. This realignment is transforming what ORD

does and how ORD does it in order to:

 Ensure that ORD’s research addresses the most impor tant environmental problems facing the Agency and the nation;

 Fully capitalize on ORD’s ability to conduct ITR to solve these problems;

 Be solution-oriented so that ORD’s work informs, en ables, and empowers sustainable solutions to these problems;

 Work closely with ORD’s partners to identify needs and conduct relevant research in a timely and responsive manner that meets actual, not perceived, partner needs, along with support for interpretation of complex data and conclusions; and

 Help ensure scientific integrity is the backbone of the Agency.

Dr. Francis used five words to describe ITR. It is integrated because it involves implementing systems thinking and integrative approaches to solve comple x challenging problems. It is transdisciplinary because it involves the widest span of disciplines to bring different perspectives to the table. It i s innovative because major challenges are not incremental probl ems and they require innovation. It is catalytic because of the need to act catalytically and spark further action among others. Finally, it is

visible because communication is essential in the design, definition, conduct, transfer, and implementation of the work ORD does if it is to hav e an impact.

The attributes of an ITR process are that it is par ticipatory (end-to-end), follows a critical path, a nd delivers the desired product. The results must be: relevant to decisions, compatible with existing p olicymaking processes, accessible to appropriate policy makers, timely, and in a usable format. In additio n, policy makers must be receptive to the research res ults.

The vision for the new Safer Products for a Sustain able World (SPSW) Program is that EPA science will lead the sustainable development, use, and assessme nt of chemicals by providing a system of integrated decision support tools for more effective and effic ient chemical management. Dr. Francis explained th at for the SPSW Program, “chemicals” refers to intenti onally produced/manufactured chemicals, particles, and materials and the products into which they are incorporated. This program is needed because EPA cannot efficiently or effectively assure the safety of chemicals with currently available approaches. This new program will develop innovative, systematic, an d efficient approaches and tools needed to inform more sustainable solutions to the design and manage ment of chemicals throughout their life cycles in a manner that reduces negative environmental and soci etal impacts while increasing economic value.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 6 The SPSW Program will lead to smarter, more effecti ve and efficient testing, assessment, and management of chemicals. It will focus on understa nding the life cycle of chemicals and chemical mixtures, targeting those chemicals (or their bypro ducts) that are intentionally manufactured for commercial use. It will support research into alte rnative product formulations using green chemistry and green engineering principles, leading to the design of safer chemicals and products. It also will pro vide much higher throughput tools for the prioritization and biological screening of chemicals based on exposure and toxicity pathways. In addition, the pr ogram will: develop and apply innovative models fo r predicting exposures and dose and assessing risks f or single and multiple chemicals, link predictive pathways with in-life effects using smarter testing and applying new principles for next-generation ri sk assessments, and improve technologies for managing risks and catalyzing solutions. The SPSW will include applications to human health and individual ecological species.

ORD is working to collaboratively develop and imple ment this innovative research program. ORD is integrating elements across ORD’s current research portfolio into an ITR program, including resources from part or all of the following programs: Nanote chnology (all of this program), Computational Toxicology (all of this program), SP2 (part of this program), Endocrine Disruptors (all of this progra m), Human Health (part of this program), and Human Heal th Risk Assessment (part of this program). It will

include both intramural and extramural research. B ecause the SPSW will focus on the Agency’s highestpriority chemical needs, close collaboration across ORD and with the program and regional offices is required to develop and implement an innovative pro gram that will serve to modernize the way chemicals are designed, evaluated, and managed. For this pro gram, ORD will need to develop and enhance partnerships with industry, academia, nongovernment al organizations (NGOs), and agencies in the United

States and other countries.

ORD hosted an initial problem formulation workshop with the program and regional office partners. The workshop was held on May 13, 2010, in Washington, D C. It provided the opportunity to work collaboratively during the problem formulation and to build a shared vision. Together, ORD and its partners identified key problem areas and began to develop a plan for working together to develop an I TR program. The program and regional offices were ask ed to nominate participants and 11 offices and Region 6 sent one or more representatives to the wo rkshop. The program office and regional partners identified problem areas that need to be addressed.

A workshop with ORD senior scientists and managers was held on May 27, 2010. At this workshop, key scientific questions necessary to successfully solv e the problem areas identified by ORD’s partners in the program and regional offices were developed. The s cience questions continued SPSW problem formulation, and will lead to an ITR portfolio that develops intelligent testing strategies and evalua tion approaches of inherent properties, and improves the relevance of assessment methods. Twelve ORD laboratories and centers participated in this works hop with senior scientists and managers.

A second workshop with the program and regional off ice partners was held on July 8, 2010, in Washington, DC. At this workshop, the problem form ulation and scientific questions were verified. Th e strategy for engagement of stakeholders external to EPA was discussed, and ORD solicited review of the draft framework and input on opportunities for stak eholder engagement. The program offices that attended this workshop were the Office of Chemical Safety and Pollution Prevention (OCSPP), Office of Water (OW), Office of Children’s Health Protection (OCHP), Office of the Science Advisor (OSA), and Office of Environmental Information (OEI).

Dr. Francis provided a diagram of the SPSW framewor k. She explained that Research Area 1 (RA1) is Developing Integrated Evaluation Strategies, and th e parameters to consider are inherency, exposure, hazard, and management. The work on RA1 feeds into RA2, which is Improving the Relevance of Assessment and Management Methods for Chemical Safe ty. This area looks at how one takes the information and applies it for a regulatory decisio n, site assessment, or other purpose. The work und erBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 7 RA1 and RA2 feeds into the targeted research needs of the program and regional offices that will be addressed under RA3, which is Targeted Application of Integrated Evaluation, Assessment, and Management Methods. Dr. Francis noted that all wor k feeds back into improving the assessment and management methods.

The four levels for RA1 are:
 Level 1: Inherent Properties of Chemicals
 Level 2: Prioritization and Screening
 Level 3: Targeted Testing
 Level 4: Systems Models of Adverse Outcomes

The two levels for RA2 are:

 Level 1: Next Generation Risk Assessments
 Level 2: Risk Management Approaches

Dr. Francis then presented a schematic that illustr ates the different levels in the research areas. Information on the chemical is gathered and decisio ns are made about its inherency, exposure, hazard, and management. Parameters for all levels are used in the integrated evaluation strategies. She poin ted

out that as the resource needs and level of effort increase, the residual uncertainty decreases.

Dr. Francis concluded her presentation by describin g the next major steps for the SPSW. There will be a more detailed briefing for the BOSC at the October Executive Committee meeting. ORD will continue to work with program and regional partners to identify other opportunities and will develop a research portfolio. The SPSW Program is expected to be oper ational by October 2011.

Dr. Francis asked if there were any questions.

Referring to the schematic presented by Dr. Francis , Dr. Chuck Haas mentioned that the BOSC has been looking at various decision analysis techniques, in cluding value of information (VOI). He suggested t hat ORD may want to consider moving modeling up earlier in the stream to help assess the needs downstream. He also mentioned the work on portfoli o evaluation that had been undertaken by the BOSC. Dr. Francis responded that she was aware of these e fforts and ORD is discussing how to incorporate

them.

Dr. Philbert asked about the intended customers for the program’s outputs. Dr. Francis replied that t he program will develop tools for use by all the EPA p rogram offices. These tools also can be used by others; for example, they can be used by other fede ral agencies to prioritize chemicals for testing an d by industry for making decisions about safer chemicals . There is a broad audience of users. Dr. Philber t asked about the technical proficiency of these vari ous audiences. The presentation did not mention

communication and efforts to train the various user s on how to use the tools. Dr. Francis responded t hat the users will have different levels of technical p roficiency and the program will need to include eff orts to
ensure that those who need the tools know how to us e them to address their needs.

Dr. Ryan complimented Dr. Francis on her presentati on. He expressed some concern that the process might become unwieldy with so many different office s involved. He asked if this new program would subsume the SP2 Program and others or if these curr ent programs would maintain their integrity and somehow report to the SPSW Program. Dr. Francis re plied that the primary client of the new program is OCSPP and this office is working closely with ORD, along with Region 6 (the lead region for this area)

, to develop the program. The SPSW Program represent s a new way of doing business and it is expected that the EPA program offices involved with the prog ram will communicate it to other partners and catalyze their involvement. With respect to the SP 2 Program, the entire program will become part of t heBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 8 SPSW Program and the SP2 Program will no longer exi st. This also is true for the Nanotechnology, Computational Toxicology, and Endocrine Disruptors Programs.

Dr. Olden noted that there was no mention of suscep tibility studies as a function of exposure or risk in the presentation. He asked Dr. Francis to comment on t his. Dr. Francis explained that the presentation w as a brief overview. Life styles, genetics, age, and ot her issues are addressed in the scientific question s but she did not go into that level of detail. Dr. Olde n asked how the program planned to engage social an d behavioral scientists; he noted that they are impor tant in reaching communities. He suggested that th ey should be involved in providing advice on translati on. Dr. Francis replied that there are not many so cial and behavioral scientists in ORD so the program pro bably will seek this expertise through extramural grants; however, ORD wants to engage them in the de sign process so that they can provide valuable advice, particularly on how to get the tools into a format that users can apply.

Dr. Sayler thanked Dr. Francis for her presentation and said that the Board is looking forward to the discussion of this program in October.



### Mid-Cycle Progress Report for the Safe Pesticides/S afe Products Research Program Dr. Elaine Francis, National Program Director (NPD) , Safe Pesticides/Safe Products Research Program,

ORD

Dr. Francis provided some background and history on the SP2 Research Program. The program is providing OCSPP with test methods for use in develo ping testing guidelines by which chemical and agricultural industries conduct and submit data to assess potential human and ecological risks for mor e than 25 years; conducting research on underlying sc ience to assist in interpretation of data from indu strysubmitted studies; and responding to OCSPP’s reques ts on specific shorter term research needs by providing results on the effects, exposures, risk a ssessment, and/or risk management of chemicals or classes that are of immediate concern to the progra m office. The biotechnology research program was

initiated in FY 2002.

The SP2 Research Program has three LTGs:

 LTG 1 —(1) prioritization of testing requirements, (2) en hanced interpretation of data to improve human health and ecological risk assessments, and ( 3) decision making regarding specific individual or classes of pesticides and toxic subst ances that are of high priority.

 LTG 2 —probabilistic risk assessments to protect natural populations of birds, fish, other wildlife, and non-target plants.

 LTG 3 —decision making related to products of biotechnolo gy.

The BOSC program review of the SP2 Research Program took place February 7-9, 2007, in Research Triangle Park, North Carolina. Dr. Anna Harding ch aired the BOSC Subcommittee, and Dr. Barry Ryan served as the Vice-Chair. Seven additional experts completed the Subcommittee. The program was assessed in terms of relevance, structure, performa nce, quality, scientific leadership, and coordinati on and communication. The final report for this program r eview was transmitted to ORD on July 23, 2007, and ORD submitted a response to the BOSC’s review on Ja nuary 12, 2008.

The BOSC thought the SP2 Research Program was a ver y successful program. Its quality was high, which was supported by strong evidence of relativel y high publication and citation rates in high-visib ility journals of significant scientific reputation, by t he immediacy with which the papers were recognized, and by the ultimate use of the research by the Agency. The program’s goals were well articulated and its framework was well thought out, logical, and laid o ut in a reasonable and integrated manner. The relevance of the program to the Agency’s mission wa s clear and apparent, and it was filling a unique niche. The program appeared to be making solid pro gress on achievement of all three LTGs and inBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 9 meeting intermediate range milestones. The scienti fic leadership of the program was strong. It inclu ded a community of highly trained and energized researche rs, many of whom are leaders in their field. The strategies for coordination and communication were very good and there was vertical and horizontal

coordination and communication within and outside E PA. There was extensive interaction with the Office of Prevention, Pesticides, and Toxic Substan ces (OPPTS, which now is OCSPP) demonstrated at the review, and good communication with Science To Achieve Results (STAR) grantees and other researchers at STAR meetings as well as professiona l meetings.

The BOSC assigned a rating of exceeds expectations for LTG 1, and a rating of meets expectations for

LTGs 2 and 3. The 22 recommendations in the BOSC re port were organized under the following nine categories:

 Clarify Annual Performance Goals (APGs) and Annual Performance Measures (APMs) (4 recommendations)

 Strengthen Exposure Research (2 recommendations)

 Clarify Criteria for Decisions Made (2 recommendat ions)

 Improve Ecological Modeling Research (3 recommendat ions)

 Improve Biotechnology Research (2 recommendations)

 Enhance Cross-Disciplinary Approaches, Collaboratio ns, and Communications (5 recommendations)

 Continue Current Practices (2 recommendations)

 Nanotechnology Research (1 recommendation)

 Additional Information for Further Reviews (1 recom mendation)

The mid-cycle progress report builds on the origina l comments and recommendations made by the BOSC at the program review. It captures the original co mments, ORD’s 2008 response, and the anticipated actions and timeline for implementation. The progr ess report also describes the program’s progress in addressing each comment and recommendation and iden tifies further actions and the timeline for those actions. The report includes a table that summariz es all of this information.

Four of the original recommendations fell under the topic Clarify APGs and APMs. These included:

Recommendation 2–

Retain flexibility of research structure to emergin g science and clarify the

APGs/APMs ; Recommendation 3– Clarify the relationship between APGs and APMs, and ensure consistency between the text and the research ; Recommendation 7– Emphasize the need for transparent validation/verification of research products ; and Recommendation 14– Revise APGs to ensure there are sufficient resources to reach goals . In its 2008 response, ORD noted that improving A PGs and APMs is an ongoing process. ORD indicated that the next up date of the MYP will: clarify the generic relation ship between APGs and APMs, reflect new metrics for APGs /APMs agreed upon with OMB, and reflect improvements in clarity and consistency in APGs/APM s. In addition, ORD will reword the specifically identified APG to clarify the distinction that ORD develops methods/models, while the validation is conducted by an independent group of experts. The updated MYPs will continue to have APGs/APMs that are achievable given the program’s available r esources.

The SP2 Program has made progress in addressing the se recommendations and implementing the response actions. Revised MYP guidance was issued in 2008, which provides more details concerning ORD’s approach to capturing the program’s work thro ugh APGs and APMs. The APMs/APGs now are Web-based to allow more flexibility and to facilita te the evolving nature of both the research and the efforts to capture and communicate the results. OR D’s National Homeland Security Research Center (NHSRC) initiated a 1-year pilot in October 2009 fo r which the APMs include explicit mention ofBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 10 partner(s) and delivery dates as well as a partner “feedback loop.” The results of this pilot will be evaluated later this year to inform ORD’s guidance on APGs and APMs.

The SP2 Research Program MYP has not been revised s ince the program review because the program is undergoing a merger with other research programs to develop the SPSW Research Program. The BOSC’s recommendations will be considered in this new prog ram, which is expected to be operational in FY

2012.

Two of the BOSC’s recommendations fell under the to pic of Strengthen Exposure Research. These

included: Recommendation 4– Greater emphasis is needed on exposure-related rese arch and

Recommendation 6– Perform an integrated evaluation of human health to provide advice on program balance, especially with respect to exposure . ORD’s 2008 response was that it would shift FTEs for exposure research into the SP2 Program. ORD was de veloping an Implementation Plan for exposure research that was being integrated with the effects research; it was expected to be completed in 2008. ORD’s response also indicated that the next update of the MYP would incorporate the strengthened exposure research, and include an approach that pro vides stronger evidence of linkages to exposure research conducted through other ORD programs, and that is relevant to OPPTS’ needs, for improved

communication.

With regard to these recommendations and responding actions, ORD shifted exposure research FTEs into the SP2 Research Program. ORD also is developing i ntegrated exposure-effects spatially explicit ecological risk assessment models. A partners’ wor kshop on models development will be held July 13-15 with OCSPP. A draft research plan should be prepare d by September 2010, and a final research plan by January 2011.

Integrated multidisciplinary research is being cond ucted to address the Agency’s highest priorities re lated to perfluorinated compounds (PFCs). The exposure r esearch is integrated with that of effects and risk management, and it is informing Agency decisions. The exposure research strategy workshop was held in March 2010, and a workshop report was completed in July 2010. The draft research plan is expected to be completed by August 2010, and finalized by Decem ber 2010. Since the BOSC program review, there have been two international PFCs symposia—one in Ju ne 2008, and the other in June 2010. A special journal issue was published in 2009 from the 2008 w orkshop, and two special journal issues from the 2010 workshop will be published late 2010 or early 2011.

The SPSW Research Program is being developed with r esources from parts or all of the SP2, EDCs, Computational Toxicology, Human Health, HHRA, and N anotechnology Research Programs. This new program will improve the leveraging of resources, r esearch planning, and the implementation and communication of ORD’s research products. The BOSC ’s recommendations will be considered in under that new program, which is expected to be operation al in FY 2012.

The two recommendations under the topic of Clarify Criteria were: Recommendation 8– Clarify criteria used to select new compounds for study and expand t he current list , and Recommendation 16– Describe criteria for prioritization of future work should a dditional resources become available . ORD’s 2008 response was that the next update of the MYP will: (1) clarify how OPPTS identifies and prioritizes those research elements needed in the shorter term, based on impending regulatory decisions or data ga ps; (2) provide greater detail on the prioritization pr ocess used to accelerate research previously identi fied as high priority, should additional resources become a vailable; and (3) provide stronger descriptions of potential new research directions based on discussi ons with OPPTS senior managers.

The ORD transformation and the development of the S PSW Research Program will provide ORD a more rigorous and reiterative process to work with progr am and regional office partners as well as external stakeholders, across all of its laboratories and ce nters. Prioritization of the science questions wil l be included from problem formulation through product d elivery. The leveraging and prioritization ofBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 11 resources and research efforts as well as communica tion of research products will be improved. As the SPSW Program develops, the BOSC’s recommendations w ill be considered. Dr. Francis reminded the BOSC members that the SP2 MYP had not been updated because of development of the SPSW Program.

The three recommendations under the topic Improve E cological Risk Assessment Approaches were:

Recommendation 9–

Begin movement towards an ecosystems approach that fully assesses population and community risks ; Recommendation 10– Further develop mathematical foundations that under pin current efforts ; and Recommendation 11– Pursue collaborations and extend development to adv ance high performance computing methods for probabilistic ris k assessment . ORD’s response in 2008 indicated that the shift of exposure FTEs into the program wi ll result in moving toward an integrated (exposureeffects), spatially explicit risk assessment progra m for targeted population and communities that will expand their utility. ORD indicated that these reco mmendations would be addressed through the development of the exposure Implementation Plan and would be incorporated into the next iteration of t he MYP. At the time of the response, efforts were ong oing to develop Web-based applications of ORD products and to seek research partners to help prov ide tools that ORD’s clients can readily access.

Since the BOSC review, exposure FTEs have been shif ted into the SP2 Research Program and integrated exposure-effects ecological risk assessment tools a re being developed. The program is working with EPA’s OEI to incorporate state-of-the-science high performance computing and visualization techniques. In addition, the program is working with the Nation al Center for Computational Toxicology (NCCT) on its research to build a Virtual Tissues knowledgeba se and a cell-based tissue simulator focused on the Virtual Liver (v-LiverTM) and the Virtual Embryo (v- EmbryoTM). The knowledgebase will be a free publicly available tool that synthesizes published experimental observations on the effects of chemica ls on the potential toxicological processes. The cell -based tissue simulator will simulate chemical-indu ced effects in the liver and the embryo using three int erconnected systems micro-circulation, cell and molecular response, and tissue response.

The two BOSC recommendations under the topic Improv e LTG 3–Biotechnology were:

Recommendation 1–

Include approach to address issues of mitigation po tential on gene transfer, effects on non-target organisms, and targeted species resis tance ; and Recommendation 12– Broaden the scope of the program to include additional topics identified by the reviewers. ORD’s 2008 response indicated the following: (1) field-scale protocols for non-targ et species effects were being developed/applied; (2 ) a workshop on Pollen Mediated Gene Flow was held in 2 007; (3) a report on testing and evaluation of resistance management models that track development of resistance in genetically modified crops will b e released in 2009; (4) limitations in resources prev ent expansion into other areas; and (5) the program is continually seeking partners (e.g., in 2007, a join t Request for Applications [RFA] on food allergenic ity was issued with the National Institute of Allergy a nd Infectious Diseases [NIAID]).

Since the BOSC review, budget constraints have resu lted in resources either being eliminated or realig ned to address higher priority Agency issues. An integ rated exposure-effects ecological assessment resear ch program is being developed and the program has leve raged resources to characterize the effects of

chemical and non-chemical environmental stressors o n plant populations. In addition, the SP2 Program is supporting ORD’s new Biofuels Research Program. In the area of food allergenicity, the program issued a joint RFA with NIAID, the Food Allergy Project, a nd the Food Allergy and Anaphylaxis Network, which collectively awarded 16 grants (4 by EPA) tha t are being tracked. This research will be complet ed in late 2010/early 2011. A joint workshop, held in 2008, led to publication of a paper on the state-o f-thescience and remaining research needs as well as a s ession at the 2009 Society of Toxicology meeting. EPA issued a new RFA in 2009, and the awards are pe nding. It is anticipated that there will be four awards, each with a period of 3 years. The results from past activities have been published or submit ted for publication and are either in press, accepted, or in review. No further biotechnology research wi ll be

conducted.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 12 There were five BOSC recommendations under the topi c Enhance Cross-Disciplinary Approaches, Collaborations, and Communications. These were: Re commendation 5– Mechanisms to improve communications between groups doing research on LTG s 1 and 2 are recommended ; Recommendation

13– Maintain and build upon existing cross-disciplinary and cross-organizational collaborations ; Recommendation 17– Grow and collaborate in the areas of statistical an alyses, bioinformatics, theoretical mathematical model building, and probab ilistic risk assessments ; Recommendation 21– Emphasize communication with other federal laborato ries ; and Recommendation 22– Develop a more focused communications program to regions and other program offices . ORD’s 2008 response indicated that the update of the MYP will provide greater det ail on the extensive ongoing collaborations with scientists in other federal agencies and research o rganizations. Significant collaborations were occu rring

in the area of bioinformatics with STAR-funded Envi ronmental Bioinformatics Research Centers and the program would continue to seek new collaborations. Four senior bioinformaticians and systems biologists had been hired. The program had initiat ed efforts to improve coordination and communications. An ORD-OPPTS (and other program/re gional offices) senior managers’ meeting was to

be held in 2008.

Since the BOSC review, the SP2 Research Program has strengthened its cross-organizational and crossdisciplinary partnerships across the ORD laboratori es/centers, within EPA, with other federal agencies

, and with states. Examples of these partnerships ar e provided in the progress report. ORD implemented actions to enhance efforts in bioinformatics and sy stems biology. ORD awarded two new STAR Centers in the form of cooperative agreements to allow for greater interactions between EPA and academic scientists (in 2008 and 2009). The program is usin g community of practice (CoP) approaches to communicate and receive input from scientists acros s sectors from around the world. In addition, NHEERL has established a new Integrated Systems Tox icology Division and has advertised for a seniorlevel Director. ORD and OCSPP senior scientists an d managers met in November 2009, to identify and prioritize research needs. Addressing these needs w ill be advanced further through the development and implementation of the SPSW Research Program, which is expected to be operational in 2012.

The two recommendations under the topic Continue Cu rrent Practices included: Recommendation 19– The peer-review process should be continued , and Recommendation 20– Continue to reward scientific
excellence and minimize administrative burdens . ORD’s 2008 response indicated that the program continually follows existing guidance and policies to ensure that programs and products are appropriat ely peer reviewed. In addition, ORD uses all available mechanisms to reward and retain its scientists and to
recruit new ones.

The progress report states that the 2006 Peer Review Handbook, 3rd Edition still governs ORD’s approach to peer review, and that approach is used by the program. Efforts are ongoing to use all

mechanisms available to reward and retain the SP2 R esearch Program scientists and managers and to recruit new ones when warranted. The program has br ought on board postdoctoral fellows, graduate students, student interns, and Association of Schoo ls of Public Health (ASPH) fellows. In addition, s ome of the senior scientists hired by ORD through the T itle 42 authority spend some of their time on SP2 issues. Researchers and managers continue to recei ve rewards for their efforts devoted to the SP2 Research Program through the EPA and ORD awards pro cesses and the Science and Technology

Achievement Awards.

The recommendation that falls under the topic Nanot echnology was Recommendation 15– More rapidly develop a research program in nanotechnology and en courage other international organizations . In 2008, ORD responded that a Nanomaterial Research St rategy (NRS) had been developed. The response also indicated that EPA was collaborating with othe r federal agencies to develop complementary researc h portfolios and with academia and industry to fill k nowledge gaps. In addition, the program was collaborating internationally and was part of the O rganisation for Economic Co-operation and Development’s (OECD) efforts.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 13 Since the BOSC review, ORD has implemented the NRS (in 2009) and added an intramural component to the program. ORD’s nanotechnology program compleme nts those of other federal agencies, and is collaborating with the research of other government agencies through the OECD. In addition, joint and coordinated RFAs with other federal agencies, the U nited Kingdom, and the European Commission have been issued under the STAR Program.

Recommendation 18–

Map service awards (as well as peer-reviewed papers ) to individual program elements to better designate high quality products was the only recommendation under the topic Additional Information for Reviews. In 2008, ORD r esponded that it will continue to include service

awards in staff members’ biosketches for all review s and in integrated tabular format, where possible. Guidance regarding the value-added of collecting an d presenting more detailed information for BOSC reviews was being discussed by ORD and the BOSC at the time of the response.

The BOSC Executive Committee meeting that took plac e at the time of the response did not result in any agreement regarding the tracking and reporting of a wards for ORD’s program reviews. The subject of demonstrating the high quality of the program’s res earch remains a priority. The current plan is to demonstrate the perceived quality of the research t eam and its technical and scientific products by providing partner/client testimonials and interview s, and by using bibliometric analysis. ORD is exploring new bibliometric approaches to measure no t only quality of the work but also performance of the various research programs. These new approaches will be implemented in 2011. ORD will continue to engage the BOSC Executive Committee in developin g appropriate bibliometric measures to be used in the program reviews.

In closing her presentation, Dr. Francis expressed the Agency’s gratitude to the BOSC Subcommittee tha t conducted the review and provided thoughtful commen ts and recommendations. She also thanked the BOSC Executive Committee for the opportunity to pre sent the progress that had been achieved since that review. Many comments and recommendations have bee n addressed. For example, there is improved integration of exposure research, expanded collabor ations with partners, and improved communication of research products. In addition, the SP2 Program ha s continued with commendable good practices. The

other comments and recommendations from the review will be taken into consideration as the new SPSW Research Program develops. Dr. Francis said that s he looks forward to continued interactions with the

BOSC Executive Committee.

Dr. Sayler thanked Dr. Francis for her presentation and asked if the BOSC members had any questions.

Dr. Olden stated that in the section on metrics for measuring impact, bibliometrics was mentioned; however, the ultimate metric is the impact on publi c health. Is ORD making an effort to gather information on the impact of the program on public health? Dr. Francis replied that ORD has been grappling with how to measure the impact of its pro grams. ORD currently does not have the tools to do

so. EPA has asked the National Academies for its i nput on effective measures and ORD has been working with other agencies on this as well. Most of the measures are anecdotal rather than quantitat ive. Dr. Francis said that ORD would welcome input from the BOSC on effective metrics for measuring the impact of ORD research programs. Dr. Olden also as ked if ORD had used the Agency’s Title 42 authority to bring in scientific leadership from ou tside EPA. Dr. Francis responded that most of the experts who have been hired under the Title 42 auth ority are from outside the Agency.

Dr. Philbert asked if the $8 million for nanotechno logy research was for both intramural and extramura l research. Dr. Francis responded that both were inc luded, and she added that the FY 2011 budget is $20 million. Dr. Philbert inquired about the split bet ween the two, and Dr. Francis replied that approxim ately $7 million is for extramural research and the remai nder is for intramural research, personnel, and oth er expenses. Dr. Philbert then asked about the fate o f the SP2 Program given the new SPSW Program. Will the work be carried on under that new program? Dr. Francis explained that some of the SP2 research would be continued under the SPSW, in particular, t he spatially explicit modeling. The work dealing with population level research would be carried out under another program. In response to Dr. Francis ’BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 14 request for input from the BOSC on appropriate metr ics, Dr. Philbert mentioned that the BOSC had recommended that ORD look at how the research progr am and its products affect legislation, rulemaking, policy, and other outputs beyond publication in the scientific literature.

Dr. Olden asked if the program was allowed to do pu blic education. He stressed the need to educate the public about the safety of new technologies, geneti cally modified plants, and many other issues. Dr. Francis answered that she was not aware of any rest rictions with respect to educating the public; howe ver, that is more the role of the program office, which has a division that deals with outreach and educati on. Dr. Olden noted that ORD plays an important role in translating research so that it has an impact on public health, and public education is an essential component of that effort. Those who develop the research also should plan for public education at t he outset of the program. Dr. Sayler pointed out t hat there are limited funds within ORD to perform this important role.

Dr. Ryan, who served on the BOSC Subcommittee that conducted the program review of the SP2 Research Program, said that he thought the mid-cycl e progress report addressed all of the questions an d issues that were raised by the Subcommittee.



### Mid-Cycle Progress Report for the Human Health Risk Assessment Program Ms. Becki Clark, Acting Director, National Center f or Environmental Assessment (NCEA)

Ms. Becki Clark explained that she was serving as t he Acting Director of NCEA while Dr. Peter Preuss i s on a temporary assignment. She introduced the othe r EPA staff members who were joining her on the videoconference from Washington, DC. Ms. Clark sai d that she moved to NCEA in 2007, just before the

BOSC conducted its review of the Human Health Risk Assessment (HHRA) Program. Since that review, Ms. Clark has seen substantial progress within NCEA on addressing the issues raised by the BOSC; she added that the BOSC review was very helpful in movi ng the HHRA Program forward.

The HHRA Program is managed by NCEA, which is the e ntity within ORD that develops human health assessments, conducts research on human health risk assessment methods, and develops guidance for assessments. NCEA occupies a critical position in ORD between the researchers in other ORD components that are generating new findings and dat a and the regulators in the EPA program offices and regions who must make regulatory, enforcement, and remedial action decisions.

The three LTGs of the HHRA Program are:

 LTG 1: Integrated Risk Information System (IRIS) an d other priority health hazard

assessments— Agency, state, and local risk assessors use the sta te-of-the-science health hazard assessment information provided on priority substan ces in their decisions and actions to protect human health from risks posed by environmental poll utants.

 LTG 2: State-of-the-science risk assessment models, methods, and guidance— EPA programs, states, and other risk assessors use the risk assessment models, methods, and guidance provided to enhance, through the incorporation of c ontemporary scientific advances, the quality and objectivity of their assessments and decision-m aking on environmental health risks.

 LTG 3: Integrated Science Assessments (ISAs)— As mandated in the Clean Air Act, the ambient air criteria pollutants are reviewed and IS As revised to reflect the best available scientific information on identifiable effects on public healt h and the environment from exposure to the pollutant, and this information is used by the EPA Office of Air and Radiation in its review and promulgation of the National Ambient Air Quality St andards (NAAQS) to protect public health with an adequate margin of safety.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 15 These LTGs are identified in the HHRA Multi-Year Pl an (MYP) that was last updated in August 2007; Ms. Clark noted that the MYP will be updated follow ing further consideration of the Path Forward in implementing integrated transdisciplinary research programs across ORD.

The activities for LTG 1 (IRIS and other priority h ealth hazard assessments) include:

 Developing human health assessments (e.g., tetrachl oroethylene, methyl tertiary butyl ether, ethylene oxide, trichloroethylene [TCE], acrylamide , formaldehyde, asbestos, and 72 others).

 Preparing Provisional Peer Reviewed Toxicity Values (PPRTVs) for EPA’s waste site clean-up program (Superfund): PPRTVs for 69 chemicals were completed in FY 2009.

 Developing Incidence Response Assessments (e.g., Hu rricane Katrina health impact assessment of debris incineration, impacts assessment of dust from collapse of the World Trade Center, Gulf Oil Spill).

The activities for LTG 2 (state-of-the-science risk assessment models, methods, and guidance) include:

 Uncertainty analysis

 Identification of possible modes of action

 Physiologically-based pharmacokinetics (PBPK) model ing

 Approaches to quantification

 Approaches for assessing risk of environmental expo sures to susceptible populations

 Approaches for cumulative risk assessment.

Under LTG 3, the program produces ISAs that provide the scientific bases for EPA’s air quality decisio nmaking. The activities include:

 Ozone—completed February 2006; underway – first dra ft November 2010

 Lead—completed September 2006; Lead ISA Information Call-in – 2010

 Particulate Matter—Completed 2009

 Nitrogen Oxides—ISA and Health and Environmental Cr iteria – both final in 2008

 Sulfur dioxide—ISA and Health and Environmental Cri teria – both final in 2008

 Carbon Monoxide—Completed 2010.

In the report on the 2007 review of the HHRA Progra m, the BOSC provided positive feedback on all aspects of the program: relevance, structure, qual ity, performance, leadership, collaboration, and outcomes. LTGs 1 and 3 received a rating of meets expectations from the BOSC, and LTG 2 was assigned a rating of exceeds expectations. The BOS C offered 10 specific recommendations that fell int o three major areas: (1) planning and implementation , (2) customer needs, and (3) coordination and

communication.

To address Recommendation 1: Assess program needs in order to increase productio n of IRIS and

PPRTV Assessments and Recommendation 5: Establish goals for increasing the number of IRIS

assessments to meet client needs , the program implemented a new, streamlined IRIS process in May 2009, and the HHRA Program has quickly demonstrated progress. The IRIS logistics team was created to centralize all aspects of the administrative suppor t for IRIS, enhance efficiency, and relieve the

administrative burdens from the scientific staff. In addition, the program meets with the client offi ce to better understand its assessment needs. Also, to a ddress these two recommendations, the HHRA Program streamlined the production of PPRTVs and in FY 2009 , 69 PPRTV assessments were added to theBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 16 database. New program metrics were negotiated with the Office of Management and Budget (OMB), which take into consideration the complexity and nu mber of assessments. The program also initiated th e NexGen Risk Assessment pilot project in May 2009, w hich involves incorporating molecular systems biology and gene-environment interactions to advanc e risk assessment, with the goal of evaluating more

chemicals in less time.

The old IRIS process involved 26 steps and the new, streamlined process has only 7 steps. The new process allows more control of the scientific revie w, which accounts for much of the acceleration. St ep 4 of the new process includes a listening session, wh ich is designed to increase the transparency of the

process.

The HHRA Program has quickly demonstrated progress under the new IRIS process. In FY 2006 and FY 2007, only 2 final assessments were posted on IRIS each year. In FY 2008, 5 final assessments were posted on IRIS. In the first three quarters of FY 2009, only 1 final assessment was posted on IRIS; however, after the new process was implemented, 6 f inal assessments were posted on IRIS in the fourth quarter, and 3 were posted in the first three quart ers of FY 2010. Ms. Clark pointed out that in May 2009, there were 15 assessments undergoing interage ncy review; since implementing the new process, 13

of those assessments have been moved forward. In c omparing the actual number of final assessments posted on IRIS with the number targeted in the prog ram metrics, Ms. Clark said that she thinks the program will reach its target for posting in FY 201 0.

To address Recommendation 2: Develop a mechanism for retaining IRIS assessments older than 10 years

on the Web site , the program will:

 Update assessments that are more than 10 years old and have new studies that may impact a toxicity value or a cancer weight of evidence descr iptor.

 Put assessments requiring extensive analysis into t he standard IRIS process; update those with no new data to indicate they are still current.

 Place assessments requiring limited analysis into t he update process (chemicals will be batched).

The IRIS Update Project was started in FY 2009, and the first batch of assessments is anticipated to s tart the review process in the fourth quarter of 2010. T he update process will include the following:

 A Federal Register

notice announcing the IRIS Update Project agenda a nd calling for scientific

information.

 Comprehensive search of scientific literature on ea ch chemical.

 Draft health assessment development.

 Combined simultaneous review of the draft by EPA an d other federal agencies via the Federal Standing Science Committee.

 Public comments on draft assessments, followed by i ndependent external peer review under

FACA.

 Final IRIS assessment reflecting public comments an d independent external peer review will replace old assessments on the IRIS database.

The HHRA Program has made considerable progress in addressing Recommendation 3: Continue to develop ties with the National Center for Computati onal Toxicology (NCCT) and provide formal input. The program participated in the May 2009 NCCT ToxCa st meeting. Based on NCEA’s suggestion, chemicals on the IRIS agenda or nominated for asses sment in the PPRTV program, are being added to ToxCast Phase II. NCEA also is participating in th e cross-ORD postdoctoral fellows program, and some NCEA scientists have been detailed to NCCT. Also, NCEA has made joint presentations with NCCT onBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 17 the future of toxicology and risk assessment. Most importantly, the program is collaborating with NCC T on the NexGen Risk Assessment pilot project. The c hallenge is to figure out how to take the toxicity data and translate them into information that is importa nt for risk assessment. Three assessment tiers hav e been proposed for NexGen.

To address Recommendation 4: Capture HHRA responsiveness to national emergencies and difficult clean-up sites in overall framework of the program , the HHRA Program is tracking past and present emergency response support activities and is engage d in internal discussions about how to describe thi s support in the next version of the HHRA MYP. Ms. C lark pointed out that it is very difficult to predi ct how much effort will be needed to support future em ergencies; therefore, NCEA is determining what resources have been needed in the past as one means of estimating what might be needed in the future. NCEA is making an effort to reach out to the region s through the NCEA “Regional Road Shows,” which are briefings designed to inform the regions about what NCEA is doing and how the Center might be of assistance to them. They are working to make NCEA the “go to” organization for high quality and rapid scientific support. Some examples of this include: development of the polychlorinated biphenyls (PCB s) exposure estimation tool for PCBs in caulk; review of the University of Michigan Dioxin Exposure Study to provide perspective for Region 5 on how the stud y results could inform Agency decision making; assistance to Region 7 by accelerating the completi on of the hexavalent chromium IRIS assessment; and assistance to Region 9 (Hawaii) and the Office of A ir Quality Planning and Standards (OAQPS) on assessing the health risks associated with sulfur d ioxide from volcanic activity. In addition, NCEA i s assisting with the Gulf oil spill emergency respons e. These activities include:

 Dioxin Formation and Risk Assessment

– Prepared screening risk assessment for workers and general population.

– Informed development of sampling plan measuring dio xin during controlled burns at sea.

– Developing approaches that will use measured dioxin emission factors to estimate potential

risks to human health.

 Fish Consumption Rates Assessment

– Providing information to characterize fish consumpt ion rates, which will be used with

measurements of oil-related contaminant concentrati ons to assess human health risks associated with consuming Gulf fish.

– Collaborating with OW and the Food and Drug Adminis tration (FDA).

 Risk Assessment for Gulf Swimmers

– Assisting OW in developing guidelines to inform dec isions concerning risks of spilled oil to

swimmers.

– Developed risk assessment exposure scenario, the ex posure factors used for the scenario, and specific health-based benchmarks.

 Toxicity of Chemicals in the Gulf

– Provided toxicity information for chemicals of conc ern related to the Gulf oil spill, including those likely to be present in crude oil as well as those used in chemical dispersants.

In response to Recommendation 6: Consider well developed PPRTVs as source for IRIS a ssessments

, NCEA reviewed the PPRTVs and found two—cobalt and v anadium pentoxide—to develop into IRIS assessments. The program also has sought advice fr om the programs and regions on their assessment needs. The highest priority needs will be addresse d through IRIS; for more targeted needs, NCEA is consulting with the programs and regions to determi ne if a PPRTV assessment would meet their needs.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 18 NCEA has taken action to address Recommendation 7: Steps need to be taken to ensure the transparency of decisions made in the process of performing asse ssments . These actions include:

 IRIS Assessments

– Implemented new IRIS process in May 2009, which inc ludes multiple opportunities for federal agency review, external peer review, and pu blic comment.

– Incorporated IRIS listening sessions for the public and stakeholders, and briefings for other agencies (e.g., Department of Agriculture, FDA) on high profile chemicals.

– Making comments from federal agency review publicly available.

 HERO (Health and Environmental Research Online)—a d atabase of scientific studies used to develop EPA risk assessments (http://www.epa.gov/he ro)

– Expanded to include IRIS assessments as they are de veloped, which allows the pubic to readily access studies on which decisions are based

.
 ISAs and NAAQS

– Restructured ISA with concise summary and integrati ve synthesis of key findings.

– Focusing on key policy-relevant findings.

– Developed causality framework used in ISAs, which p rovides transparency and consistency in drawing conclusions and causal judgments.

 EPA’s Reanalysis of Key Issues Related to Dioxin To xicity and Response to NAS Comments

– Defined process clearly for study selection.

– Held a scientific workshop (February 2009) to ensur e that EPA’s response to the National Academies focused on key issues and reflected the m ost meaningful science.

In response to Recommendation 8: Consider recruitment of senior scientists , the program has hired senior Oak Ridge Institute for Science and Educatio n (ORISE) fellows to provide support for complex science issues (e.g., quantitative application of g enomics and high-throughput data into chemical risk assessment, mutagenic mode of action). In addition, an internationally recognized senior science manag er has been hired under Title 42 as one of the program ’s Division Directors. The program is expanding it s capacity in LTG 2 (NexGen) with post-doctoral fello ws from ORISE, the American Association for the Advancement of Science (AAAS), and ASPH.

NCEA has made some progress in addressing Recommend ation 9: The program is encouraged to make PPRTVs more available for use in hazardous waste si te assessments and promote use as appropriate

. The program currently makes PPRTVs available to all EPA staff and by request to state and other partners in waste site assessments. The HHRA Progr am is reaching out to the program offices (beyond the Office of Solid Waste and Emergency Response [O SWER]) to publicize the existence of PPRTVs. NCEA is engaged in ongoing discussions with OSWER t o make the PPRTV database publicly available. It is anticipated that this will happen in the near future.

Several steps have been taken to respond to Recomme ndation 10: The program needs to consider information on potential public health as it priori tizes chemicals . The HHRA Program has participated in extensive meetings with the program and regional of fices regarding the selection of priority chemicals . In addition, the process for adding chemicals to the I RIS agenda has been revised to include public healt h information, to make it more transparent, and to ad d a “feedback” loop to the programs and regions. T he Federal Register

notice for new nominations includes more transpare ncy on how decisions are made. Public health information (exposure and toxicity) i s being considered in identifying priority chemical s. As an example, several phthalates have been added t o the cumulative health assessment because of publi cBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 19 health concerns. Ms. Clark noted that the phthalat es cumulative assessment is the first step in consi dering risks of exposure to multiple chemicals and it may serve as a framework for extension to other compounds in the future.

Ms. Clark closed her presentation by stating that s he is excited about what the program has been able to achieve in the past few years since the BOSC review

.

Dr. Sayler thanked Ms. Clark for her presentation a nd asked if there were any questions. He noted tha t Dr. George Daston, a former BOSC Executive Committe e member who chaired the HHRA Subcommittee that conducted the program review, had joined by telephone and he asked if Dr. Daston had any questions or comments. Dr. Daston said tha t this program is a cornerstone of EPA’s work; so many programs and processes within EPA rely on it. Therefore, the program must be designed and implemented well, and both are true for the HHRA Pr ogram. These assessments are valued by organizations throughout the world and the demand f or IRIS assessments far exceeds the available resources of the program to do the assessments. Dr . Daston indicated that he is very pleased with the effort the program has put into streamlining the IR IS process. The review process (both internal and external) has been an impediment to completing asse ssments in a timely manner.

Dr. Daston thought the program was doing a good job of leveraging the efforts of other organizations. He was very pleased to see the collaboration with NCCT . He stated that NCEA and NCCT are leaders in their fields and they need to work together to make useful tools available for risk assessments. He encouraged the program to continue this interaction . He stressed the need to be diligent about ensuri ng the transparency of the process for prioritizing ch emicals for risk assessments. Dr. Daston thought t he next BOSC program review should assess whether the transparency of that process is adequate. Although the program has attempted to address Recommendation 8, which dealt with recruiting senior scientists, the program has not been able to fulfill the spirit of that recommendation. Therefore, the program sho uld keep this recommendation on its radar screen for fu ture action. Dr. Daston noted that the HHRA Progra m received very good ratings in the last program revi ew and it has taken steps to make the program even

better.

Dr. Cozzens asked how the program plans to build em ergency response into its program planning. From the presentation, it appears that NCEA is attemptin g to assess how much effort has been expended on such efforts in the past. Do you have a record of how many full-time equivalents (FTEs) are allocated to emergency response each year? Ms. Clark replied th at NCEA is trying to document that effort. Ms. Kacee Deener explained that she has been workin g on assessing the emergency response effort during the past 2 years so that the program can use this information to predict future effort. There are discussions underway about the best way to incorpor ate this into the MYP. Dr. Stan Barone acknowledged that this is a difficult task because emergencies are unpredictable; however, having the historical data will be beneficial in planning for future emergency response needs. He added that, in recent years, NCEA has seen an increase in the numb er of requests for assistance and the time that it takes to respond to these requests. Therefore, this is n ot just an historical assessment. Dr. Cozzens prai sed the program for attempting to track its emergency respo nse support. She also suggested that having this information available could be valuable in justifyi ng to OMB why certain performance goals were not met when resources were diverted to emergency respo nse support. Dr. Olden agreed, stating that it is important to communicate what percentage of the pro gram’s effort is dedicated to emergency response support and what percentage is devoted to achieving the program’s strategic LTGs. Ms. Clark agreed an d added that the percentage allocated to emergency re sponse support is probably around 10 to 15 percent. NCEA would like to have a better handle on this, ho wever, so it can set aside resources to meet these

needs.

Dr. Tharakan asked if the program had done a risk a ssessment for the workers responding to the Gulf oi l spill. Ms. Clark replied that the program particip ated in the risk assessment for the workers that wa s done by the National Institute for Occupational Safety a nd Health (NIOSH).BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 20 Dr. Demerjian asked about the volatilization of the oil, formation of semi-volatile organic compounds (SVOCs), and the photochemical transformation to se condary organic aerosols (SOAs). Is this aspect being considered in the assessment? Dr. Barone res ponded that ORD is involved in the efforts of the other federal agencies, and those aspects are being considered. Dr. Demerjian asked if areas around t he spill are being monitored to determine its effects. Dr. Barone replied that measurements are being ta ken real time and the focus is on the safety of the wor kers. The longer term focus will be the environmen tal effects, and additional research and monitoring wil l be needed.

Dr. Philbert asked what is being done on an interag ency basis to ensure that appropriate data are bein g captured now so that they can be used in follow-up research. Dr. Barone responded that a database is being created to store all of the data being collec ted and the database is being made publicly availab le on

the Internet.

Dr. Olden stated that he did not hear any mention o f epigenetic regulation. Is that being considered? Dr. Barone replied that other parts of ORD (e.g., N CCT) are looking at epigenetic regulation. The

National Institute of Environmental Health Sciences (NIEHS) National Toxicology Program (NTP) is involved as well. ORD is trying to incorporate thi s work into its assessment.



### Ecosystem Informatics Session

Ecosystem Informatics: Interdisciplinary Graduate Education and Research Linking Ecology, Computer Science, and Mathematics Dr. Julia Jones, Ecosystem Informatics Program, Ore gon State University (OSU)

Dr. Julia Jones explained that ecosystem informatic s involves collaboration among natural scientists (ecologists), computer scientists, and mathematicia ns. It addresses pressing problems of natural reso urce management and explores alternative approaches to c onceptualizing problems, modeling ecosystem processes, and uncertainties.

Important contributions to key problems in ecology include: uncertainty in ecosystem models, predicti ng extreme events, automatically detecting events and organisms, predicting community response to disturbance, and quantifying species responses to e nvironmental change. The experiences OSU has gained during these collaborative effects provide v aluable lessons for educators and resource managers

.

Dr. Jones explained that ecosystem informatics does not merge the different disciplines involved but fosters collaboration among them. For biophysical scientists, ecosystem informatics can help with hug e data streams from burgeoning sensor networks. It a lso can help with alternative conceptualizations an d models of ecological and ecosystem processes. For mathematical scientists, ecosystem informatics provides the opportunity for developing entirely ne w methods in computer and mathematical sciences. I t also brings together a more diverse study group to contribute to environmental problem resolution. So me ecosystem topics that can benefit from ecosystem in formatics include: scaling and uncertainty in cycl ing of carbon and nitrogen; stability and resilience of ecological communities; natural disturbance proces ses; temporal and spatial predictions; and structure and function of hierarchical branching networks.

Ecosystem informatics research builds on large data sets and ecological process understanding, develops new models, and compares alternative modeling appro aches.

The work on ecosystem informatics began at OSU with the award of a National Science Foundation (NSF) Interdisciplinary Graduate Education and Rese arch Training (IGERT) program grant in 2003. The effort was initiated by Long-Term Ecological Resear ch (LTER) senior natural scientists who asked mathematicians and computer scientists to collabora te to expand the scope of LTER. In 2005, the Ecosystems Informatics program had its first Ph.D. students and OSU hired two young faculty members.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 21 In 2007, there were 15 Ph.D. students in the progra m and OSU hired three more young faculty members. By 2009, there were 30 Ph.D. students, the faculty was getting additional grants, and two postdocs wer e hired.

Dr. Jones described a study of the collaborative ne tworks in the ecosystem informatics group. The stu dy found that 87 percent of new ties in the program we re with people in different departments; 50 percent of

the collaborative ties resulted in new ideas that c ould not have been produced individually; 68 percen t of new idea ties were between fields; and 76 percent o f new idea ties were between departments. She note d that working together has produced ideas or finding s that could not have been produced individually or by a single department.

One example of ecosystems informatics research invo lved the problem of habitat selection. Organisms do not select the first habitat they encounter. Th ey visit some number of habitats and then select on e. The “refractory period” is the time spent visiting habitats before making the selection. This is a mathematical problem—to select the optimal stopping time. What is the optimal number of potential habitats to visit before selecting one? The optimal “refractory period” is n/e where n = total number of possible habitats and e = natural logarithm. How ca n we use this problem to understand organism behavior in space?

Another example of ecosystems informatics research focused on the question: How do the spatial dynamics of emergent stream insects affect populati on dynamics? The mechanisms are drift and flight.

The “critical domain” is the minimum size of habita t required to maintain persistence of a population. In a single channel, the answer is a length, but in a stream network, the answer is more complex. What is the

effect of network structure on time to extinction? What is the effect of arrangement of predators (fi sh) on time to extinction? The persistence of the populati on depends on the balance between the net reproduct ive rate, downstream advection, and upstream dispersion by diffusion or other process. The outcome of interest are the critical values of the variables g overning those competing processes, the thresholds below

which extinction is certain.

A third example of ecosystems informatics research concerned fire effects on forest stand dynamics. How does non-stand-replacing fire affect forest sta nd age distribution? How does time-varying fire af fect

forests? Hazard rate is used to formulate the mode l and it is solved analytically. This yields a mod el that can predict how long it will take for a forest stan d experiencing a change in fire return interval to reach a new equilibrium.

A fourth example of ecosystems informatics research involved anomaly detection. Many environmental sensors produce large datasets (temperature, carbon flux, etc.) and the data contain erroneous observations. How does one automate the process of error detection? Machine learning of Bayesian hierarchical models provides the necessary quality control. This is done by creating a probabilistic model of the domain, represented by a Bayesian Network. The process model (how the true temperature behaves) models normal behavior and the observation model (how the temperature is measured by the sensor) includes a generic fault model. If the dif ference between the sensor reading (O) and computed P (process model) is large enough, then an anomaly is declared. An ideal quality control model should produce two things: (1) a label that distinguishes data anomalies, and (2) an imputation of the true value (with some confidence measure).

A fifth example of ecosystems informatics research concerns bioacoustics. Many organisms are difficul t to census (e.g., birds). Acoustical recordings of these organisms may help detect their movement and abundance. New low-cost sensors provide continuous audio data and machine learning can automatically identify bird songs in recordings.

A final example of ecosystems informatics research involves species modeling. Many species have been monitored (e.g., birds) and the datasets are large and of variable quality. These long-term datasets containBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 22 information on species’ responses to climate variab ility and machine learning can infer species distribution (single or multiple species). The goa l of a multiple-species model is to simultaneously predict the occurrence of multiple species. It off ers the advantages of identifying and understanding communities, detecting competitive exclusion, explo iting inter-species correlations to improve predict ion accuracy, and predicting hard-to-detect species bas ed on easy-to-detect species (e.g., detect understo ry based on canopy). The three methods are to model e ach species separately (M0), model each species separately but perform model selection jointly (joi nt model selection, M1), or capture the correlation structure among the species (M2). It is hypothesiz ed that M2 will be better than M1, and M1 will be better than M0. Seven different modeling methods f or species distribution of birds at Hubbard Brook were compared and it was determined that stacked ra ndom forests (a model of type M2) were best for thi s dataset and measure.

In summary, Dr. Jones stated that ecological proble ms offer many challenging opportunities for mathematicians and computer scientists. Collaborat ions of ecologists with computer scientists and mathematicians can address major problems in enviro nmental science and contribute to sustainable management of ecosystems. These collaborations req uire significant investment of time and energy by senior faculty in participating disciplines, and th ey can enhance participation and diversity in scien ce, technology, engineering, and mathematics (STEM) dis ciplines. They also help to create a workforce trained to succeed in the new information-based, hi ghly technological society. Successful collaborati ons in ecosystem informatics involve exposure to ecosys tem and resource management issues in shared field experiences, interdisciplinary communication for pr oblem formulation, attention to disciplinary and interdisciplinary balance, committed senior researc hers, and development of a network of collaborators

. These collaborations can contribute fundamental ins ights to basic and applied ecology, and also may le ad to new advances in computer science and mathematics

.

Dr. Jones then asked if there were any questions. Dr. Olden asked about validating the ecosystem mode l. Do you make predictions and then see how close they are to reality using a standard procedure for validation? Dr. Jones replied that the model is va lidated using data that were not used to build the model. She also noted that it is important to make sure th at the methods do not take advantage of scale. The y use the same type of validation that is used in other f ields (e.g., validate against standard bioassays an d pathology).

Mathematics of Ecological Dispersion Dr. Enrique Thomann, Department of Mathematics, Ore gon State University

Dr. Thomann referred to the project on the effects of fire on forest stand dynamics that was mentioned by Dr. Jones in her presentation. Initially, there wa s a significant communication barrier between the ecology student and the mathematician working on th is effort; however, after some time the ecologist began asking questions that were almost mathematica l. It is important for the ecologists and the mathematician to use a common “language.” For this project, the ecologist had to figure out if he wan ted to develop a model that would predict the future or detect the effect of changes.

Dr. Philbert asked if the “language” they developed was universal. If a group on the East Coast carri ed out a similar project, how similar would their “lan guage” be to that developed for this OSU project? Dr. Thomann replied that the language is not univer sal and this effort is just the beginning of develo ping such a language. A great deal of effort must be ex pended in the beginning to communicate and describe the project and what needs to be done. After there is agreement on definitions, the project can move

forward.

Referring to two graphs that were included in Dr. J ones’ presentation, Dr. Sayler asked if they were generated from a model or from actual data. Dr. Th omann replied that they were generated from the model. Dr. Sayler commented that this almost becom es a sensitivity analysis to point the researcher i n aBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 23 particular direction. Dr. Thomann responded that t he graph identifies different age classes and how l ong it will take to transition from one to another.

Dr. Tharakan asked if it was possible to take the e cosystem informatics model and work backwards to se e if it accurately modeled the changes. Dr. Thomann answered that it was an important part of the thesi s for this project to use historical data to assess t he accuracy of the model. He added that the data c ould not justify strong conclusions. Dr. Jones mentioned th at this student began as a field scientist who had a math phobia; however, he was drawn to complex computer s imulations to explain what he was observing in the field. Therefore, he collaborated with mathematici ans to develop an analytical model that did a much better job at explaining the observations than a si mulation model. Dr. Sayler commented that, now tha t the processing power is available, the issue is how to assemble and interpret the data. Dr. Philbert stated that when a human population is exposed to some dru g, only a small subset of people have an adverse effect. Can such singularities be detected with th is model to explain why individuals in a group beha ve differently? One participant replied that it would be difficult because trees can reproduce asexually and they do not grow in a constant temperature. In some forests, there has not been a fire for 1,000 years , and other forests burn frequently. Dr. Jones noted tha t different species of trees respond differently to fire. The model could detect that difference by age of tr ee and species. This approach could be applied to detecting the singularities to which Dr. Philbert r eferred. She added that one colleague is looking i nto how to predict disease epidemics with this model. A participant commented that one of the advantages of this model is that it goes from a conceptual view t o a more rigorous mathematical view to help explain phenomena.

Dr. Haas observed that the OSU collaboration works because that organization has ecologists, mathematicians, and computer scientists who are use d to inquiry-based research. EPA, for the most par t, relies on contractor-based mathematical and compute r science support rather than internal staff. Coul d that restrict the degree of cross-over interaction at EPA? Dr. Demerjian thought that collaboration w ould more likely be restricted because of the discipline . He noted that ecologists do not have a long hist ory of building models. In addition, it is difficult to f ind 50 years of data to offer an adequate dataset. Dr. Thomann commented that an ecologist would typic ally rely on computer simulation to explain observations; however, that is not the approach tha t would be used by a mathematician. One participan t
mentioned that there has been some reluctance at EP A to hire mathematicians because the Agency is an applied science organization and it is not obvious where a mathematician would fit in. In addition, computer scientists usually are not viewed as part of the interdisciplinary team solving an environmen tal problem.

Computer Science and EcoInformatics Dr. Tom Dietterich, Director of Intelligent Systems Research, School of Electrical Engineering and Computer Science, Oregon State University

Dr. Tom Dietterich described two data driven scienc e projects: (1) Species Distribution Modeling and (2) Computer Vision for Automated Identification of Arthropods. The Species Distribution Modeling project involved predicting spatio-temporal distrib ution of species (single and multiple). The model could be used for: species mapping to guide field survey s, reserve design to optimize conservation benefit versus cost of acquisition/opportunity costs, and r eal-time management of barriers to bird migration (skyscraper lighting, wind farm operations, airplan e-bird interactions). OSU collaborated with the Cornell Lab of Ornithology’s Ebird.org, which is a real-time, online checklist program that provides b asic

information on bird abundance and distribution at a variety of spatial and temporal scales. Volunteer “birders” upload checklists of birds observed and n ot observed. Ebird.org receives 1.5 million data po ints per month, from birders with a wide mix of expertis e. The challenges for the Species Distribution Mod el

are fourfold:

1. Detectability—Bird may be present but not be detect ed by observer.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 24 2. Experts versus Novices—Novices are more likely to f ail to detect, and they may confuse a bird with other species.

3. Sampling Bias—Birders stay close to home so the sam pling is skewed to population centers.

4. Partial Information—Observations may provide only p artial information.

Dr. Dietterich stated that birds are most detectabl e during migration and mating. Models that ignore detectability can become confused (e.g., predict th at forests are poor bird habitat in July and August ). Detectabilty depends on the observer and his/her ef fort as well as the species, time of year, density of vegetation, weather, and other factors.

Occupancy/detection models (Mackenzie et al.) attem pt to separate occupancy and detection given the observation data by using two logistic regression m odels—one for occupancy and one for detection probability. In machine learning, the logistic reg ression models are replaced with boosted regression trees (BRTs), which are known to be one of the best metho ds for species distribution modeling under perfect detection. This novel BRT methodology can handle la tent variable models unlike existing BRT methods.

To address the challenge of birder expertise, they looked at what species the novice birders over- and under-reported. They also estimated the expertise l evel of each birder. The hypothesis was that the Species Distribution Modeling accuracy could be imp roved by down-weighting (but not discarding) novice data. This added an expertise component to t he Occupancy/Detectability model. As the model becomes more sophisticated, it will be able to make better predictions.

Because the citizen scientists reporting observatio ns stay fairly close to home, the sampling tends to be skewed to human population centers. The challenge was how to make good predictions across the entire United States. They accomplished this by using cov ariate shift reweighting. They confirmed that the weighting approach improved the model results.

Dr. Dietterich noted that partial information comes from, for example NEXRAD weather radar, which provides an approximate measure of the number of bi rds but does not indicate the species. Similarly, night flight calls are a diagnostic for some specie s, but not for others. These data can be incorpora ted using a collective Hidden Markov Model (cHMM), whic h provides algorithms for inferring the most likely state and path.

Dr. Dietterich indicated that direct observations o f bird migration (e.g., by radio tagging) are limit ed. The goal of BirdCast, a pilot radar ornithology project that focuses on the mid-Atlantic region, is to gen erate real-time migration forecasts. These data will hel p scientists understand how birds “decide” when to continue along their migration path, how they “choo se” their path and where they decide to stop over, and predict how climate change and land use will affect these decisions. The data also can be used to ide ntify and remove migratory hazards; for example, reduce l ighting in skyscrapers during major migrations, manage wind farms to minimize migration interferenc e, and alert air traffic to bird/plane collision ri sk. The data also provide birders with information on w here and when they can observe target species.

Dr. Demerjian asked if anyone had done any correlat ions with weather patterns and conditions. Dr. Dietterich replied that the current belief amon g ornithologists is that, for short-distance migrat ions, the birds usually wait for favorable winds, but for long-distance migrations, the birds have a particu lar time that they must leave.

The second data driven science project described by Dr. Dietterich was Computer Vision for Automated Identification of Arthropods. He explained that ar thropod population surveys of freshwater streams ar e used for assessing stream health, measuring the suc cess of stream restoration, and understanding basic stream ecology. This project involved the developm ent of a new survey concept in which the technician would collect the samples in the field and manually clean the samples. The specimens would be dumpedBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 25 into a robotic device that automatically singulated , photographed, identified, and sorted them. An ex pert would manually identify the “rejects.”

The pilot project focused on using this new survey concept to identify nine taxa of stoneflies. There were 3,826 stonefly image; 773 specimens and 9 classes w ere identified. The error was estimated by threefo ld cross-validation. The error rate using the state-o f-the-art method was 16.1 percent, and the error ra tes for pilot Method 1 (using boosted dictionaries) and Met hod 2 (using stacked evidence trees) were 4.9 perce nt and 5.6 percent, respectively.

The current work is focusing on identifying the 50 most abundant taxa of Ephermeroptera, Plecoptera, and Trichoptera (EPT), which are the basis of EPA E nvironmental Monitoring and Assessment Plan (EMAP) surveys. The EPT are identified independent ly by two experts. The initial results for 29 taxa indicate that the precision varies from species to species. The challenge is detecting and rejecting “novel” species. Can the system detect that a specimen does not belong to any of the training classes? This question poses interesting problems for the compute r scientists.

Dr. Dietterich closed his presentation by identifyi ng the next steps for this project, which are to im prove shape descriptors, conduct tests on EMAP specimens, initiate the soil mesofauna project, improve the rejection of distracters, and initiate in situ video surveillance. He asked if the BOSC members h ad any questions.

Dr. Philbert asked if Dr. Dietterich had looked at the pathology literature on the automated reading o f pathological slides. Dr. Dietterich responded in t he affirmative, particularly for breast cancer tiss ues. OSU’s goal is to develop something similar. Dr. Ph ilbert suggested that Dr. Dietterich contact Dr. Da niel Farkas, Bioengineering Department, The Weizmann Ins titute of Science at the University of Pittsburg an d Dr. Simon Watkins, Department of Cell Biology and P hysiology at the University of Pittsburgh School of Medicine about the work they are doing. Dr. Philbe rt asked if the specimens were dead and Dr. Dietterich confirmed that they were and that they w ere preserved in alcohol.

Dr. Haas asked if the stonefly data were from local streams, and Dr. Dietterich replied that they were collected in streams from New Mexico to Oregon. Dr . Haas then asked if they had looked at the value o f incorporating contextual information. Dr. Dietteri ch indicated that they had not, and added that his dream is to develop a retrainable technology that can be used for many problems.

Dr. Sayler thanked Drs. Jones, Thomann, and Dietter ich for their presentations.



### Ecosystem Informatics Framework for Marine Biogeogr aphy and Natural History at Regional to Global Scales Dr. Henry Lee II, EPA, ORD, NHEERL, Western Ecology Division

Dr. Henry Lee explained that the present goal of th is effort is to capture the global biogeographic distributions of all the near-coastal nonindigenous species in the North Pacific along with their rele vant habitat and invasion traits. The future goal is to adapt the Pacific Ecosystem Information System (PC EIS) to capture climate related traits for near-coastal species in the Northeast Pacific and Arctic. The d atabase then could be used as a knowledge engine for genera ting species’ climate risk profiles.

The basic principles and assumptions are: (1) for many questions, classes for habitat requirements an d/or physiological tolerances will suffice; (2) informat ion will be capture by hierarchical classes where possible to accommodate different levels of knowled ge and needs; (3) geography is biology—use distributions to infer habitat specificity; and (4) queriable natural history requires standardization even at the loss of some ecological nuances. A graphical i nterface is used for capturing distributions of nat ive and nonindigenous species because this is much easi er to use than a spreadsheet format.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 26 The first step in the management strategy for the r esearch data is to develop an informatics topology to collect and store biological data. The regional an d local databases from EMAP are feeding into the database. Presently, more than 17,000 taxa are in PCEIS. The objective is to have at least 95 percen t of the reported species in the Northeast Pacific and A rctic for fishes and most invertebrate taxa. Dr. L ee presented an atlas of the nonindigenous species in the North Pacific and then did a brief demonstratio n of

PCEIS.

According to the Millennium Ecosystem Assessment, b iodiversity will decline globally if there is a continued focus only on ecosystem services. Dr. Le e noted that although extinction is the ultimate ecological insult, there are many lesser insults, i ncluding population decline, range contraction, population fragmentation, and loss of associated ec osystem functions for services. The objectives of the project are to: (1) develop automated procedures t o identify near-coastal species at greatest risk to different types of climate alterations using rule s ets based on biogeographic distributions, natural h istory attributes, and physiological traits; (2) overlay s pecies’ biogeographical and habitat distributions w ith projected climatic alterations at multiple scales; and (3) analyze risk for suites of taxa from the Gu lf of

California to the Arctic.

The Arctic is predicted to experience larger temper ature increases than the mid- and low-latitudes. Additionally, polar species have “nowhere to run” i n response to a warming ocean. The results of this effort can be used to help shape public opinion and policy, identify locations that will be most impac ted by climate change, identify types of climatic alter ations that will have the greatest impact on biodiv ersity, and develop potential mitigation options. Dr. Lee presented a framework for a climate-induced alternative futures species distribution prediction system. He noted that, because of the complexity of the rule sets, PCEIS will migrate from Access to the We b.

The International Union for Conservation of Nature (IUCN) Red List approach needs to be modified for climate risk, specifically for near-coastal species . EPA needs to work with the IUCN more closely in the future to accomplish this. A major challenge is th at there is considerably less data available for ne arcoastal species than for terrestrial flora and faun a. Vulnerability is being predicted based on the t hree components of rarity. Multidimensional analysis of rarity types is based on Rabinowitz’s Rarity Class es (which are similar to the criteria used by the IUCN for its Red List). The first component of rarity is whether the species has a high or a low population size. The second is whether the species has a larg e or small geographic range. The third component is whe ther the species can occur in a broad range of

habitats or whether it is restricted to a more narr ow range. How vulnerable is the habitat to differe nt types
of climatic alterations?

Data from PCEIS can be used to assess, for example, the species of chiton in the Northeast Pacific (Gu lf of California to Chukchi Sea) that are most at risk to temperature increases or those most at risk to ocean acidification. The number of species endemic to ea ch ecoregion and the number of species in more than one ecoregion were identified. A cross-walk betwe en ecoregions and depth was done using the PCEIS depth classification schema for chitons. Dr. Lee p resented the preliminary rule set for pCO 2 and ocean acidification organism traits affecting vulnerabili ty. He noted that developing these rule sets is a large part of the research. One possible output could be a color-coded matrix that identifies the risk to c limate change (e.g., increase in air temperature, increase in water temperature, loss of wetland habitat) for various species.

Ms. Zhuikov asked if the PCEIS database is availabl e to those outside of EPA. Dr. Lee responded that the Agency will make a version of PCEIS available t o the public in October 2010. This version will contain information on about 1,000 non-native speci es in the North Pacific. EPA has an interagency agreement with the U.S. Geological Survey (USGS) to get the database online. Ms. Zhuikov said she thought that the U.S. Fish and Wildlife Service had an invasive species database. Dr. Lee replied tha t it is

USGS that has that database. He added that EPA is working with USGS and also is trying to connectBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 27 with the Smithsonian and its database. Dr. Lee men tioned that there are several hundred nonindigenous species databases.

Dr. Sayler asked if there were any international co nnections. Are other countries attempting to do anything like this? Dr. Lee responded that the wor k is funded partly by the Japanese. WED has had limited success in working with China, and complica tions with Canada because the database did not run on Canadian systems since they had not installed Wi ndows updates. Dr. Lee said that WED hopes to foster the relationship with Japan.

Dr. Olden asked how many species have been entered into PCEIS and if there was a limit to the number i t can contain. Dr. Lee replied that they have data o n all of the fish on the West Coast and PCEIS will include all of the major taxa. Dr. Haas asked if t here is a precise definition of a native species. Dr. Lee answered that they are considering native species t hat are from the pre-Columbian era. Dr. Demerjian asked if the database users are entering data into the PCEIS. Dr. Lee replied that Microsoft Access d oes not allow multiple, simultaneous users, but he can take the back ends and merge them. Unfortunately, this approach makes Dr. Lee the gatekeeper. Dr. De merjian asked about quality control and Dr. Lee sai d that he is responsible for quality control at this point. Dr. Philbert pointed out that allowing user s to enter data makes quality control much more difficult beca use these users operate under different assumptions

. Dr. Lee agreed and added that there is a user’s man ual and documentation for the database.



### Laboratory Tour: Western Ecology Division

Modeling Ecosystem Service Tradeoffs in Response to Land Use and Climate
Bob McKane, EPA, ORD, NHEERL, Western Ecology Division

Dr. Fontaine introduced this presentation by Dr. Bo b McKane, which was prerecorded, from the Ecosystem Services Research Program (ESRP) Seminar Series held July 1, 2010.

WED is involved in developing ecosystem service tra deoffs for alternative forest management scenarios in support of the ESRP. The seminar included: an overview of the VELMA ecohydrology model and goals; monitoring, mapping, and modeling demonstrat ion (forest management alternatives and ecosystem service tradeoffs); the decision support framework Envision -VELMA; and current place-based applications and clients (Willamette Ecosystem Serv ices Project and Flint Hills Regional Applied Research Effort [RARE]). Dr. McKane noted that the work described in the seminar is the collaborative effort of EPA, Georgia Institute of Technology, Kan sas State University, Marine Biological Laboratory– Woods Hole, and Oregon State University.

Interaction of processes across wide spatial and te mporal scales requires a systems approach for manag ing bundled ecosystem services. An example of an ecosy stem service is the regulation of water quality; supporting processes include transforming, cycling and retaining nutrients and toxics in plants and so ils.

Because the many processes supporting various ecosy stem services are interconnected, actions taken to optimize one service will tend to affect other serv ices, either negatively or positively.. Well teste d models

are needed to show this interconnectedness across l arge landscapes. A model developed by the Georgia Institute of Technology and EPA-WED specifically fo r this purpose is the ecohydrological model,

VELMA – V isualizing E cosystems for L and M anagement A ssessment. VELMA is a spatially-distributed soil column based model, typically using 30 x 30 me ter columns, or pixels, for watershed and landscape

scale applications. It simulates the transport of water, nutrients and toxics down slope to streams a nd other surface waters. The pixel size can be changed if necessary. The data needs of the model are relatively simple.

The features of this model include: coupled hydrol ogical and biogeochemical cycles; flexible landscap e units and soil layers; and spatially explicit soil and vegetation dynamics–days to centuries, plots to basins.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 28 The goals are to develop a model that: (1) links e ffects to causes (identify processes controlling ecosystem service tradeoffs), (2) is applicable to a wide variety of ecosystems and regions, (3) maps “bundles” of ecosystem services across a wide range of spatial and temporal scales, (4) is easy to implement (data and calibration requirements), and (5) provides a user-friendly decision support framework to assess outcomes of alternative policie s and management decisions. VELMA simulates the effects of climate, land use, land cover, and soils on multiple ecosystem services (water quality and quantity regulation, food and fiber production, car bon sequestration, greenhouse gas regulation, and regulation of reactive nitrogen [Nr]).

VELMA has a very simple hydrological submodel. It computes the soil water balance daily for individual pixels, typically represented at 30 x 30 meters soil columns divided into four layers. Drai nage and runoff occur as a function of soil moisture con tent, which is related to soil porosity. For sandy soils, the logistic curves controlling drainage and runoff would shift to the left to simulate rapid drainage ; for clay soils, the curves would shift to the right to simulate slower drainage and greater retention of w ater.

VELMA also has a biogeochemical submodel that compu tes the exchange of carbon and nitrogen between the atmosphere, soils, plants, and streams. VELMA links the hydrological and biogeochemical processes within soil columns, hill slopes and wate rsheds. The goal is to develop a model that is bro adly applicable; for example, it will work for the Arcti c LTER, Hubbarb Brook LTER, Chesapeake Bay, Konza Prairie LTER, and HJ Andrews LTER.

The Willamette Ecosystem Services Project is focuse d on assessing the effects of changes in land use a nd climate on the provisioning and long-term sustainab ility of ecosystem services in the 30,000 km 2
Willamette River Basin in Oregon, a diverse landsca pe consisting of 70 percent forest, 20 percent agriculture, 8 percent urban, and 2 percent wetland s and other. An initial demonstration of VELMA was conducted for the HJ Andrews Experimental Forest an d LTER site, a 64 km 2 headwater basin in the

Cascade Mountains of the Willamette River Basin. V ELMA was used to assess the effects of several alternative forest management scenarios on tradeoff s among key forest ecosystem services, including th e regulation of water quality and quantity; timber pr oduction; carbon sequestration; greenhouse gases; a nd retention of reactive nitrogen.

The application of VELMA to the HJ Andrews LTER stu dy site is a good example of how monitoring, modeling, and mapping can be used together to suppo rt land management and policy decisions. EPAWED and LTER personnel have collaborated to facilit ate the exchange of information among those doing monitoring, those doing modeling, and those doing m apping. The HJ Andrews VELMA application is an example of ESRP’s national program to develop these linkages. Monitoring provides data on ecosystem service indicators (status and trends); modeling li nks ecosystem services effects to specific stressor s and provides alternative future ecosystem services proj ections; and the mapping effort synthesizes this information to provide a national atlas and maps of ecosystem services (status and trends). Communications among these three ESRP activities is critical to support client decisions, including problem formulation; scenario definition; ecosystem services metric needs; integration of data, scenar ios, and models; and assessment of tradeoffs.

Dr. McKane presented several graphs and explained t hat the model was calibrated to simulate the dynamics of forest biomass following a fire and fol lowing clear cutting in the Pacific Northwest. The model predictions were validated against local and regional scale data. The model results showed that within 70 years following clear cutting, plant biom ass only recovered to about 80 percent what would b e expected following a natural stand-replacing fire.. Because logs (and nutrients) are transported offs ite during clear cutting, the nutrient level after clea r cutting is much reduced relative to burned areas (>90% of pre-fire biomass typically remains as dead but u nburned wood following fire). The clear cut area c ould be fertilized to replace the lost nutrients, but th at may potentially have an impact on stream water q uality.

The model allows decision makers to look at the eff ects of such scenarios. Dr. McKane explained that the model did a good job of simulating the response of streamflow to clear cutting, and to daily and seaso nalBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 29 changes in precipitation and temperature – an impor tant requirement for simulating the combined effect s of land use and climate change.

VELMA also did a good job of capturing the long-ter m data on an old growth forest before it was clear cut in 1975; there was good correlation (R 2 = 0.91) between the simulated streamflow and the o bserved streamflow. Following the clear cut in 1975, the m odel also did a good job of simulating streamflow ( R 2
= 0.91). Clear cutting induced a 28 percent increa se in annual average streamflow during the first 5 years after harvest, and a 4 percent increase after 25 ye ars. These responses have implications for flood protection, maintenance of streamflow during summer low flow conditions, and water quality issues.

VELMA’s hydrologic submodel held up well when valid ated across multiple spatial scales. There was good correlation between observed and simulated str eam discharge as well as observed and simulated steam chemistry. Dr. McKane noted that the rain ty pically starts at the study area in late September/ early October after very dry summer months. The soil is like a sponge and it must become saturated before significant increases in streamflow begin. Therefo re, streamflow increases only after the hill slopes saturate, which also leads to greater nutrient flus hing. The intent of the model is to capture how su ch fundamental hydrological and biogeochemical process es respond to human decisions affecting land use,

land cover and climate.

VELMA’s biogeochemical submodel was validated using long-term data describing the response of stream chemistry to clear cutting. There was good correlation (R 2 = 0.86 for 1994 – 2006) between observed and simulated dissolved inorganic nitrogen (DIN) stream losses; there also was good correlati on between observed and simulated dissolved organic ca rbon (DOC) stream losses (R 2 = 0.81 for 1994 – 2006). Dr. McKane said that there are plans to do more spatially extensive biogeochemical validation when stream chemistry data for the 64 km2 HJ Andrew s Basin become available in 2011. He noted that the model did a good job simulating recovery of soi l organic matter and vegetation biomass following t he stand replacing fire in 1525.

Dr. McKane stated that the model can be used as a t ool for mapping ecosystem services and supporting processes. He showed maps of simulated plant and s oil carbon in the HJ Andrews landscape. The maps reflect the fire and harvest history in the area.

VELMA was used to model three alternative land uses for the 64 km 2 HJ Andrews Basin. Scenario 1— all old growth forest (historical condition)—has ma ximum ecosystem carbon stocks, maximum carbon sequestration, maximum greenhouse gas sink, less st ream discharge (25% less), and minimal stream nitrogen load. Scenario 2—all clear cut (hypotheti cal)—has highest fiber (timber) production, reduced ecosystem carbon stocks, less carbon sequestration, maximum greenhouse gas emissions, and maximum stream discharge and nitrogen load. Scenario 3—pre sent-day landcover (~45% harvested, ~55% old growth)—has intermediate ecosystem carbon stocks (m ore than Scenario 2 and less than Scenario 1), some carbon sequestration (more than Scenario 2 and less than Scenario 1), greenhouse gas sink (slight ly less than Scenario 1), intermediate stream discharg e (more than Scenario 1 and less than Scenario 2). Thus, there are tradeoffs among the three scenarios . For example, the present-day landcover for Scena rio 3 represents one sort of compromise, providing for at least some timber production while maintaining most other terrestrial and aquatic ecosystem servic es close to those for the all old growth Scenario 1 . The model does not make value judgments; it just provid es the science to inform policy decisions. There i s work ongoing to incorporate a habitat and biodivers ity (fish and wildlife populations) link to the mod el.

VELMA has been applied successfully at various scal es, from stands to catchments to basins to landscapes. Next steps include scaling up to large r landscape-scale applications, for example, the 2, 000

km 2 area surrounding JH Andrews, the predominantly agr icultural Willamette Valley and, ultimately, the entire 30,000 km 2 Willamette River Basin.

VELMA is being linked with Envision , a GIS-based decision support tool for constructin g alternativeBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 30 future scenario applications for community and regi onal planning and environmental assessments.

Envision was created by Dr. John Bolte and colleagues at Ore gon State University to allow examination of the nature and properties of coupled human and n atural environmental systems. It employs scenarios

, data, evaluative models produced by past research, and utilizes prior work in agent-based modeling and biocomplexity theory. Central to Envision, are the three-way interactions of actors, who have decisionmaking authority over parcels of land, the landscap e which is changed as these decisions are made, and the policies that guide and constrain decisions. Envision enables multi-model linkages, and additional ecological models (e.g., HexSim, FishNet) are being integrated as plug-ins. Work is underway to link a ll of the models (for stressors, ecology, terrestrial services, and aquatic services) into a common frame work.

To demonstrate some of the features of Envision , Dr. McKane presented a “flyover” visualization of Puget Sound alternative futures—current conditions, unconstrained growth, managed growth, and status quo. Such visualizations allow decision makers to view how alternative future scenarios of population growth, land use and climate may affect changes in carbon storage, water quality and other ecosystem services across large landscapes. The goal is to p roduce animations that help decision-makers visuali ze the impacts of various decision options. Dr. McKan e commented that this is a good example of linking

basic research to societal needs.

At this point, Dr. Fontaine stopped the recording b ecause of time and asked if there were any question s. Dr. Demerjian asked about the 30 x 30 meters resolu tion. Is there a profile of the soil every 30 mete rs? Dr. Denis White replied that the selection of 30 x 30 meter pixels is based on digital elevation model s. He noted that 30 meters is used because 30 meters r esolution is standard for satellite data (Landsat i s 30 meters). The soil data are for arbitrarily shaped polygons on soil maps. He mentioned that they use LTER sites because a lot of this work already has b een done for these sites. [Subsequent note from Dr

. McKane – yes, there is a 4-layer soil profile for e very 30-m pixel; total profile depth and depths of individual layers can vary from pixel to pixel, as determined from soil mapping information from NRCS and other sources.]

Dr. Olden commented that the policy makers need inf ormation on water runoff, greenhouse gas emissions or recapture, and habitat and biodiversity. Not al l of these have been integrated into the model yet so inputs are needed from other sources. An informati on management tool is needed that will predict the impacts of alternative land management decisions so that the decision makers can assess the tradeoffs. Dr. White responded that Envision is the tool that will provide that information. I t can integrate fish models, ecological models, timber harvesting models , and water quality models to provide the

information needed to assess tradeoffs.

Dr. Sayler asked if emergy is being used as a subco mponent of these models to look at sustainability. Dr. White answered that Dan Campbell at Narragansett is involved in such work. He added that emergy is one of the factors included in a study in the San L uis Valley area that WED is working on with the Cincinnati laboratory. An EPA report on this work w ill be released soon.

Dr. Haas asked if it would be helpful to get input on stakeholder preferences, noting that they have different preferences. Dr. White responded that th ere has been some work with Envision to incorporate

the values of decision makers. Dr. Olden cautioned against getting involved in the policy side; Dr. H aas said there is a fine line between developing tools for decision makers and making the decisions and establishing policy. Dr. White stated that the too l can show the decision makers the environmental impacts of their decisions. Dr. Olden commented th at this is good science but most Americans would no t know anything about this work. Ms. Zhuikov asked i f ORD had someone working on communicating this research to the public. Dr. Fontaine responde d that this research is quite new and ORD will ensu re that it is communicated to the appropriate audience s as well as the public.

Dr. Sayler thanked Dr. Fontaine for sharing the pre sentation with the BOSC and adjourned the meeting for the day at 5:19 p.m.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 31 

### T UESDAY 

### , J ULY 

### 13, 2010

Dr. Sayler called the meeting to order at 8:35 a.m. He then asked Dr. Sally Darney if she was ready t o begin her presentation.



### ORD Response to BOSC Human Health Report Dr. Sally Perreault Darney, EPA, ORD, NPD for Human Health

Dr. Sally Darney, acting NPD for the Human Health R esearch Program (HHRP) since January 2008, started the presentation by acknowledging the four Long Term Goal (LTG) leads who helped with the review and this report. The BOSC review of the HHR P was conducted in January 2009, and the report on

the review was transmitted to ORD in December 2009. ORD prepared a detailed response to that report

and transmitted it to the BOSC in June 2010. She s tated that this presentation summarizes the ORD

response.

Dr. Darney next acknowledged the BOSC Subcommittee that conducted the review, and pointed out that it included people with broad mix of interdisciplin ary expertise, including toxicologists, exposure scientists, public health experts, epidemiologists, and modelers, that corresponds with the mix of exp ertise in HHRP. Dr. Darney noted that social science expe rtise is limited in HHRP and on the Subcommittee,

but desirable for the future. She indicated that t he BOSC review provided valuable feedback for the program and significantly influenced ORD’s thinking

.

The Subcommittee was charged with evaluating the HH RP’s relevance, structure, quality, coordination/ communication, performance, and scientific leadersh ip. The BOSC indicated that the program had matured since the 2005 BOSC review, and increased i ts emphasis on public health. The BOSC found the program to be robust and that it was responsive to emerging issues. The scientific content of the HHR P was deemed to be excellent by the BOSC and the prog ram was better integrated than at the 2005 review. The BOSC found the program’s productivity to be str ong with formidable impact. In addition, the BOSC thought the program’s leadership was excellent to o utstanding.

The overall rating for the HHRP was meets expectati ons. The ratings for the program’s four Long Term Goals (LTG) were:

 LTG 1–Use of Mechanistic Data in Risk Assessment: M eets Expectations

 LTG 2–Cumulative Risk: Meets Expectations

 LTG 3–Susceptible and Vulnerable Populations: Meet s Expectations (the children’s health component exceeds expectations)

 LTG 4–Developing Tools to Evaluate Risk Management Decisions: Exceeds Expectations.

Dr. Darney noted that the goals are interrelated an d the BOSC suggested that ORD revisit this structur e.

The BOSC offered a number of general recommendation s for the program. These included:

 Add linkage with risk assessments conducted by the Agency

 Document use of models and tools by research partne rs.

 Translate research to bring the exposure and toxico logy science to bear on epidemiology and community work and thereby address real world publi c health problems.

 Make tools and models more “user-friendly” and Web- based.

 Consider altering the program structure to do these things.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 32  Expand partner engagement (generally for all health programs) both within EPA and with other agencies, institutions, and non-governmental groups

.

In its original concept, the HHRP was designed to b e a “core” program that supported other ORD research programs, such as SP2, EDCs, and Clean Air by addressing cross-cutting issues of interest to multiple EPA program offices and Regions, as oppose d to solving problems for a single office. HHRP also collaborates directly with the Computational T oxicology Program and the Human Health Risk Assessment Program in ORD to help these programs ac hieve their goals.

Since the January 2009 review, there have been a n umber of changes in ORD that will affect the next steps for HHRP. In particular, the newly proposed integrated transdisciplinary SPSW Program describe d earlier in this BOSC meeting by Dr. Francis, will integrate all chemical-related research (exposure science, toxicology, and context-specific assessmen t approaches) from several programs, including HHRP, into one program. Dr. Darney said that she i s supportive of the new SPSW Program because it brings ORD’s research on chemicals together into on e program and should make communication with EPA’s program offices more efficient.

There are many drivers for the SPSW program and ove r the last two years HHRP has been building capacity and conducting new research that is motiva ted by these same drivers, which include:

 NRC’s Toxicity Testing in the 21st Century (2007)—highlights need for high throughput, smarte r testing.

 EPA’s Strategic Plan for Evaluating the Toxicity of Chemicals (2009)—emphasizes use of computational toxicology approaches to elucidate pa thways of toxicity and develop predictive models and addresses EPA’s role in an interagency M emorandum of Understanding with NIEHS, Agency for Toxic Substances and Disease Registry [A TSDR], FDA, and National Institutes of Health [NIH]).

 NRC’s Science and Decisions: Advancing Risk Assessment (2008).

 Administrator’s five goals for EPA’s new strategic plan include “Assuring the Safety of

Chemicals.”

 ORD/AA Paul Anastas’ focus on green chemistry appro aches and the over-arching theme of sustainability.

Components of the HHRP related to risks of chemical s would be incorporated into the new SPSW Program, including the research described under LTG s 1 and 2 and part of LTG 3. This would include: Exposure Models, Factors, and Databases (e.g. devel oping data for the Exposure Factor Handbooks developed by NCEA, and reverse dosimetry models); Cumulative Risk of Pesticides and Disinfection Byproducts (e.g., Pyrethroids Cumulative Risk Asses sment to be reviewed by OCHPP’s Scientific Advisory Panel, 2012); Toxicity Pathways (with NCCT ); Virtual Liver/Embryo (with NCCT); PB/PK and BBDR Models to link exposure and health effects; In trinsic Susceptibility Factors (life stage, gender, (epi-)genetics); Biomarkers of Exposure and Effect; and Interpretation of Biomonitoring Data (e.g., NHANES data and risk assessment).

It is envisioned that after these chemically relate d components of HHRP migrate into the new SPSW program, ongoing elements related to public health, clean communities and children’s health will be incorporated into a new HHRP theme called, for the purposes of this presentation, healthy people in

sustainable communities. This new theme would ali gn with EPA’s goal of “cleaning up our communities” and focus on EPA’s cross cutting strat egies including working for environmental justice and protecting vulnerable populations (especially c hildren) and strengthening State, Tribal and international partnerships. Dr. Darney reported th at in addition to working with EPA program offices and regions, this new theme would address the research needs of EPA’s Offices of Children’s HealthBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 33 Protection and Environmental Justice (working with the EPA Administrator-appointed Special Assistants

for Children’s Health Peter Grevatt and Environment al Justice Lisa Garcia. Relationships would also b e established with the new Office of Sustainable Comm unities in the Office of Policy, Economics, and Innovation (OPEI). The program would continue to s upport research needs in children’s health, includi ng partnering with the National Children’s Study (NCS) and contributing to the Interagency Task Force on Environmental Health Risks and Safety Risks to Chil dren. In addition, there is a growing need for the Agency to address environmental justice concerns. EPA was issued a 100-day challenge from community groups following the ORD-Office of Enviro nmental Justice (OEJ) Symposium, “Strengthening Environmental Justice Research and D ecision Making: A Symposium on the Science of Disproportionate Environmental Health Impacts.” Th is challenge calls for a holistic and participatory research program in community health that includes community involvement.

Existing components of the HHRP are relevant to the new theme including LTG 3–Susceptible and Vulnerable Populations and LTG 4–Accountability. S ome of the questions addressed by this research are: How and why are children differentially expos ed to pollutants? What are long-term consequences of

in utero exposures/stress? Are aging populations at higher risk? What metrics and indicators are needed

to evaluate and remediate communities at risk? and How do we measure success (i.e., effectiveness of risk management decisions)?

The BOSC praised HHRP’s Children’s Health Program i n the review and ORD is continuing its

commitment to children’s health. Six new full cent ers (five year grants) and six formative centers (t hree year grants) are to be funded in 2010 under the Ch ildren’s Environmental Health and Disease Preventio n Centers Program which is co-funded with NIEHS. The centers’ work includes participatory research with involvement of community partners. Two workshops p lanned for fall 2010 will identify data gaps and research needs to help guide future ORD research pl anning. These workshops include the ORD-Regional Science Workshop on children’s health and risk asse ssment, and the ORD-NIEHS-OCHP workshop

Children’s Health for a Lifetime: Where Research Me ets Clinical Practice and Policy (with ATSDRSuperfund Pediatric Environmental Health Specialty Units).

ORD will continue to support the NCS Interagency Co ordinating Committee and Workgroup and development of methods and sampling strategies for the NCS. For example, ORD sponsored a workshop on exposure metrics for NCS in April 2010 and the r esulting report was well-received by NCS. In addition, ORD is conducting research to identify an d evaluate potential sources of polychlorinated biphenyls (PCBs) in schools to better understand ex posures to children, teachers, and other school workers, and to improve risk management decisions. EPA will investigate PCB-contaminated caulk, as well as other potential sources of PCBs in schools. Future planned research areas include factors tha t impact exposures in very young children and in chil d care settings as well as school building practice s and child/teacher performance.

Dr. Darney then highlighted a number of key recomme ndations by the BOSC that will help direct and prioritize future research directions. ORD’s respo nses to these key recommendations are summarized

below.

BOSC Recommendation: The program should conduct more translational res earch to link advances in fundamental exposure and toxicology science (LTGs 1 and 2) with environmental public health applications (LTGs 3 and 4).

ORD Response: The program is working to implement this recommen dation. Some of the actions

include:

 STAR grants and intramural “accountability” studies (LTG 4) are providing information on public health indicators.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 34  The Community-Focused Exposure & Risk Screening Too l (C-FERST), an innovative Webbased tool with Google map interfaces, is being dev eloped in collaboration with regional/community projects (LTG 2).

 An “Environmental Quality Index” is being developed (LTG 4).

 A STAR RFA soliciting new research on “Understandin g the Role of Nonchemical Stressors and Developing Analytic Methods for Cumulative Risk Ass essment” was issued in 2009.

 A STAR RFA soliciting new research on “Exploring Li nkages between Health Outcomes and Environmental Hazards, Exposures, and Interventions for Public Health Tracking and Risk Management” was issued in 2009.

 A third in a series of STAR RFAs for the Tribal Gr ants Program is planned for release in 2011. These grants promote community-based participatory research.

 The program is considering a STAR RFA on school env ironments and performance (in collaboration with OCHP and the Department of Educa tion).

 The program is considering a STAR RFA on Centers of Excellence on Environmental Justice (modeled after the Children’s Environmental Health Research Centers) to include communitybased participatory research.

BOSC Recommendation: Redress program imbalance within the life-stage a rm of LTG 3 such that the strengths of the childhood susceptibility research thrust are matched with an expanded research progra m addressing the elderly as well as potential subgrou ps across the entire age range.

ORD Response: The HHRP does not anticipate additional new resou rces but is using available resources on a number of projects related to this goal. Rese arch objectives include: (1) evaluate the response of different aged rats to air pollutants with the goal of informing PBBK models, (2) compare the response s of younger versus older asthmatics to air pollution , and (3) use an animal model to explore early in-utero exposures and long-term consequences on chronic dis eases later in life, such as hypertension, diabetes

, and metabolic syndrome. Related to the latter effo rt, in 2009, ORD co-sponsored an international meeting: “Contribution of Environmental Stressors t o the Developmental Origins of Health and Disease,” with NIEHS, ATSDR, the Centers for Disease Control and Prevention (CDC), and the National Institute of Child Health and Human Development (NICHD). Sev eral HHRP scientists were plenary speakers at this meeting, the proceedings of which are currentl y in press.

BOSC Recommendation: Rethink the approach to asthma (LTG 3) as a targe t condition so that it is not simply approached as a surrogate of childhood susce ptibility to new disease onset, but rather consider ed across the entire age range and in terms of pre-exi sting disease.

ORD Response: ORD will hold a workshop on asthma in fall 2010 tha t is focused on both community health and climate change. A major goal of this wo rkshop is to engage partners in the Office of Air a nd Radiation and OCHP by updating them on past researc h accomplishments and prioritizing continuing needs for research on asthma in relationship to env ironmental stressors. Current HHRP studies include controlled exposure studies on older asthmatics exp osed to inhaled particles with both respiratory and

cardiovascular outcomes to understand whether older asthmatics are at increased risk to endothelial in jury and accelerated coagulation. In addition, the HHRP is examining the role of severity of asthma diseas e in conferring susceptibility to pollutants. This rese arch will link to the new SPSW (whether toxicity pathways studied via gene expression and microRNA p rofiles are perturbed by pollutants in different ways in individuals with different asthma severity) . The new Children’s Centers will address fundamental questions about the interactions among biological allergens and ozone in the etiology and progression of asthma, and about how asthma symptom s may be controlled by dietary intervention.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 35 BOSC Recommendation: Incorporate additional case studies into LTG 4 an d attempt to extrapolate from existing case studies to other examples.

ORD Response: Additional case studies are underway with the Agenc y’s “Community Action for a Renewed Environment” (CARE) and “EJ Showcase Commun ities” programs. Also, the results from two intramural “accountability” projects summarized dur ing the 2009 BOSC review are being extrapolated to other situations as follows: (1) salivary antibodi es to water-borne pathogens are being evaluated for use in “Beaches” studies for OW, and (2) air pollution models that integrate and predict impacts of nation al and local (voluntary) actions, developed in New Hav en, Connecticut (collaborative effort with Region 1 ), are being extrapolated to Bridgeport, Connecticut, a “Showcase Community.” Additional case studies ar e expected from the new series of STAR grants on publ ic health indicators, the new Children’s Centers funded in 2010, and the new RFA for Tribal grants p lanned for 2011.

BOSC Recommendation: Restructure the HHRP for better linkages between the exposure and toxicology research and public health applications.

ORD Response: The HHRP is being restructured. Components related to managing chemical risks will go to the new SPSW Program and components related t o public health will remain in the revised HHRP. The new theme for the HHRP is healthy people in sus tainable communities. The latter will address the administrator’s goal of “cleaning up our communitie s” and cross cutting strategies of working for environmental justice and building strong state and tribal partnerships. Research to protect children ’s health will be conducted in both programs.

Dr. Darney closed her presentation with several “ta ke home” messages. The HHRP has a long history as a “core” program that has benefitted multiple ORD a nd EPA partners. The 2009 BOSC review

influenced new directions for the HHRP and ORD. In tegrated transdisciplinary programs in ORD will provide new tools for solving 21 st century environmental health problems, such as:

 Reducing risks of chemicals by identifying key even ts along toxicity pathways (existing chemicals) and designing safe new chemicals.

 Using advanced exposure and PBPK models to link exp osures to health outcomes, interpret biomonitoring data, and inform risk mitigation.

 Protecting children and other vulnerable population s by considering their unique exposures and susceptibilities.

 Enabling communities, states, and tribes to partici pate in research to identify multiple stressors, reduce harmful exposures, and improve their environ ments to create sustainable well being.

The research portfolios will include complementary intramural and extramural efforts, and invest specifically and strategically in the Administrator ’s priorities.

Dr. Sayler thanked Dr. Darney for her presentation and then asked about the definition of sustainable communities. Dr. Darney responded that sustainabil ity means maintaining a balance between our consumption of natural resources and our use of eco system services so that we can maintain well being and growth without the negative impacts that ultima tely will lead to our demise. She noted that EPA cannot accomplish sustainability on its own. It ha s to be defined on a basic level so that everyone c an get involved. The Agency needs to look for starting po ints in community-based projects and work with partners to flesh out a program. Dr. Darney said t hat ORD would like to get the BOSC’s input on the SPSW in October, so the subject of sustainability c an be discussed more at that meeting.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 36 Dr. Olden complimented the program’s efforts to foc us on sustainable communities. He mentioned that Dr. Darney’s definition of a sustainable community meshes with that used at the City University of New York. He also was impressed with the new agenda fo r the revised HHRP.

Dr. Tharakan asked if ORD is investing any effort i n the development of a checklist or criteria to mea sure whether a community is moving toward sustainability . Dr. Darney replied that Rick Linthurst, the NPD for the Ecosystem Services Program, is working on t his issue for ecosystem services and it is expected that similar efforts will be made in the health pro gram in the future.



### ORD Update—Potential Relationships Between Hydrauli c Fracturing and Drinking Water

Resources Dr. Kevin Teichman, Deputy Assistant Administrator for Science, ORD, EPA

Dr. Teichman said that his presentation would focus specifically on updating the BOSC on ORD’s efforts on hydraulic fracturing and drinking water. He men tioned that if there were follow-up questions concerning Dr. Anastas’ earlier remarks, he and Mr. Kadeli would try to respond to those questions.

The FY 2010 Congressional Appropriations Conference Report urged “EPA to carry out a study on the relationship between hydraulic fracturing and drink ing water, using a credible approach that relies on the best available science, as well as independent sour ces of information. The conferees expect the study to be conducted through a transparent, peer-reviewed p rocess that will ensure the validity and accuracy o f the data. The Agency shall consult with other fede ral agencies as well as appropriate state and inter state regulatory agencies in carrying out the study, whic h should be prepared in accordance with the Agency’ s quality assurance principles.”

Dr. Teichman presented a diagram of the hydraulic f racturing lifecycle. A well is installed at the si te, and these wells are much deeper than in the past. A re cent development is for the well to turn horizontal once it reaches the shale. A mixture of water, sand, an d chemical agents is pumped into the well. The sha le is fractured by the pressure of the fluids inside the well, and fissures form in the shale around the wel l. Sand keeps the fissures open, and natural gas flows from the fissures into the well. Water, hydraulic frac turing fluid, and water from the subsurface, which may be contaminated with other things such as arsenic, are pumped to the surface.

The FY 2010 budget amount allows EPA to spend $1.9 million on this effort. Another $2.5 million will be added in 2011. This amount would not be enough to fund a single hydraulic fracturing installation. Therefore, EPA must work with industry to move forw ard with the study. The Agency must be careful to avoid working too closely with industry, so that EP A is not accused of favoring industry. ORD wants t o involve stakeholders in the study design and hear f rom people who think their homes have been affected by hydraulic fracturing sites. People from the loc al communities and local authorities as well as tri bal representatives will be involved in study design, s o that the results will be more usable to them and the study’s credibility will be evident.

The steps in the study design are as follows: (1) define the scope of the study; (2) identify key res earch questions; (3) evaluate background information, lit erature, and data relevant to the research question s to identify research and information needs; (4) develo p an initial framework for the study and criteria f or prioritization; (5) prioritize the research and dev elop an initial study design; (6) engage stakeholde rs to inform study design; (7) peer review initial study design and revise as needed; (8) implement the stud y; (9) monitor and report progress; (10) develop resea rch products; and (11) peer review the research products.

The potential elements of the study include collect ion of background data and information, chemical characterization, potential field studies, modeling , and technology assessment. Dr. Teichman noted th at because of competition among the various companies that do hydraulic fracturing, some companiesBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 37 consider the chemical characterization of the hydra ulic fracturing fluid to be confidential; however, many in the industry also think the information should b e shared. Because of the differences across the co untry, EPA would like to do multiple field studies, which will require a collaboration of stakeholders.

In April 2010, EPA asked the SAB to provide input o n the scope of the study, the research questions, t he process to be used for prioritizing research, and t he process used for obtaining balanced input from stakeholders. Representatives from other federal a gencies, state and local governments, NGOs and associations, industry, trade associations, and pri vate citizens participated in the SAB meeting which was held April 7-8, 2010. Sixty-four written comments and 15 oral comments were received at that meeting. The final report from the SAB was released on June 24, 2010, and the primary recommendation was to focus on drinking water resources while also recogn izing the hydraulic fracturing life cycle to help identify partners.

EPA will engage stakeholders (including individual citizens, communities, state and federal partners, industry, trade associations, tribes, and environme ntal organizations) in a variety of ways to exchang e information and provide progress updates as the Age ncy plans, implements, and completes this study.

Stakeholder involvement includes:

 Facilitated public meetings (Summer 2010): EPA Regi ons 2, 3, 6, and 8

 Sector-specific meetings (Summer 2010): federal ag encies, states, NGOs, and industry

 Technical workshops (Fall 2010)

 Web-based outreach

 Peer review panel meetings, including requests for input via Federal Register notice

 Public comment during meetings and written comments

 State and federal partner consultations.

The timeline for the project indicated that meeting s with state and federal partners would be conducte d in late May/early June 2010, the Website would be post ed in June, and public meetings would be held in July and August. The draft study design will be co mpleted in September, technical workshops will be conducted in September and October, and peer review will be initiated in October. The study is expect ed to begin in January 2011, and initial study results are expected to be published by late 2012.

Dr. Sayler asked if there were any questions for Dr . Teichman. Dr. Demerjian said he was very

concerned that the air side of this issue is not be ing addressed. Very little has been done on this t opic. In addition, there are some concerns about fugitive em issions from lateral drilling. He mentioned that N ew York requires companies to provide information on t he organic materials in the hydraulic fracturing fluids, which often contain benzene, xylene, and to luene. There are no data on the emissions from hydraulic fracturing processes. Is lateral drillin g exacerbating greenhouse gas emissions? The Agenc y needs to look at these processes to ensure that the y are safe and the emissions should be monitored. Dr. Teichman thought Dr. Demerjian made some import ant points. ORD is discussing with the Office of Air and Radiation (OAR) the possibility of suppleme nting ORD’s funding so that the study can examine

some of these air-related issues.

Ms. Zhuikov commented that this study will spark th e interest of the public. She was pleased to see t he SAB’s recommendation on developing a communications plan, but she did not see it in the study design process. What does ORD plan to do to communicate t his study and its results? Dr. Teichman responded that OW will be assisting with these public meeting s and communications. ORD is working with the Office of Public Affairs to develop materials that will inform the public about this study. In additi on, the meetings will be professionally facilitated to ensu re that the discussion remains on topic. He noted that it is important that the meetings do not become too bu reaucratic or too technical. EPA wants the public toBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 38 participate in the study and to conduct it in an op en and transparent fashion. There will be efforts to
communicate with the local communities and with the media.

Dr. Olden said he thought this was a case where the BOSC should make a strong statement to ORD about the government’s need to review of the safety of th e hydraulic fracturing process. He was surprised t o learn that companies did not have to inform EPA abo ut the composition of their hydraulic fracturing fluids. The Agency needs to make sure that hydraul ic fracturing is not irreversibly contaminating our

water sources.

Dr. Tharakan commented that this appears to be an e ngineering study at this point. What are the healt h agencies doing on this topic? Dr. Teichman replied that he has been in contact with NIEHS about the public meetings, because ORD believes that the publ ic will call for testing to be done. He pointed ou t that hydraulic fracturing fluids cannot be recovere d in many cases, so testing is important to assess their safety.

Dr. Hauchman said he attended the stakeholder meeti ng that was held in Dallas. The Agency received 100 comments, the meeting was attended by more than 600 people, and it lasted 4 hours. Representative s from industry and the state regulatory commission a long with some members of the public said they were not concerned about hydraulic fracturing and they s upported the process. Others did not share their v iew, however, and it was clear that many commenters had little faith in the state oversight of these operat ions. Similar meetings will be held in Denver and New Yor k. To address Dr. Demerjian’s comment, Dr. Hauchman mentioned that Region 6 is doing a little work on air emissions associated with hydraulic fracturing, and ORD is supporting some work under t he Regional Applied Research Effort (RARE) program. He noted that there was considerable conc ern about air emissions at the Texas meeting.

Dr. Sayler asked if the SAB report was available. Mr. Susanke responded that it was provided as background material and is in the meeting notebook. Dr. Sayler thought it would be helpful for the BOSC members to review that report before commentin g further on this topic.



### ORD Update—Gulf Oil Spill Update Lek Kadeli, Deputy Assistant Administrator for Mana gement, ORD, EPA

Mr. Kadeli stated that his comments would focus on ORD’s efforts to support the Agency’s response to the BP oil spill in the Gulf of Mexico. He explain ed that it had been 84 days since the explosion tha t killed 11 workers and the oil rig sank and the plat form capsized. This is one of the worst environmen tal disasters to occur in United States’ history and it has and will continue to have significant environm ental and economic impacts. Eighty thousand square miles of fishing waters have been closed and many wildlife refuges have been threatened. There are m any people in the Gulf working on mitigation and getting ready to start remediation efforts once the spill is finally contained. EPA has 165 workers f rom field offices, the EPA Regions, and headquarters wh o are dedicated to the response efforts and this number will grow as the activities move toward reme diation.

Mr. Kadeli noted that Admiral Thad Allen is familia r with the work EPA did following Hurricane Katrina so he is aware of what the Agency can do to help. He thought the Admiral had done an effective job in leading the response efforts of the various federal agencies. This is a huge effort—770,000 barrels o f oil have been recovered or flared over the past 80+ day s, 600 vessels are assisting in the cleanup, and do zens of aircraft have been employed in the response. Re mote vehicles are being used to do much of the work to plug the well because of the depth of the leak. Millions of feet of skimmers and booms are being u sed to contain the oil with varying degrees of success. There are concerns about the volatile organic car bon from the oil as it evaporates, the air emissions fr om flaring, and the effects of the dispersants, whi ch ORD is currently evaluating. Mr. Kadeli stated that th e monitoring data, which are available on EPA's Web site, have not revealed any extraordinary air emissions o r water contaminants. Procedurally, the data are subjected to quality assurance/quality control befo re they are posted, which, for the water data, usua llyBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 39 occurs about 5-7 days following the sampling.

Although the use of dispersants in the Gulf respons e has been highly scrutinized, the dispersants are working as expected to break up the oil. Just 20 k m from the site, the plumes are breaking up and the oil is being dispersed into droplets. The EPA Administ rator has been clear that if there is evidence that the dispersants may be having a negative impact, EPA wi ll ensure that BP stops using the dispersants. It appears that the use of dispersants has been effect ive.

The Coast Guard directed BP to reduce the amount of dispersants used by 75 percent from the peak level

. On May 26, EPA issued a directive to BP stating tha t dispersant spraying should be used as the last re sort and subsea dispersant use should be limited to 15,0 00 gallons a day, which was much less than BP had been using. BP can only use dispersants with rigor ous monitoring; weather conditions, however, can be grounds for an exception. Monitoring is occurring all along the coastline and oxygen and toxicity lev els are being tested. Both oxygen and toxicity have be en at stable and viable levels.

In June, EPA did independent toxicity testing of ei ght different dispersants to determine if some were more toxic than others and if there were any concer ns about endocrine disruption. The preliminary dat a of this independent testing were released on June 3 0. The tests indicated that Corexit, the most wide ly used dispersant in the gulf, is probably as good as any of the other dispersants tested with respect to toxicity.

EPA also has set up a Website to accept submissions on technological approaches for mitigating the oil spill. More than several thousand suggestions have been submitted to the government; approximately 2,000 to EPA alone. Some of the ideas were creativ e but not deemed to be useful at this time. Follow ing evaluation by EPA, a number of the ideas were forwarded to BP (the ones focused on the well head) and others were sent to the Coast Guard. There may be some demonstration projects conducted to evaluate the efficacy of some of the proposed ideas. The Co ast Guard established a new Website about 3 weeks ago, which now serves as the one-stop-shop for sugg estions to deal with the oil spill.

EPA is conducting monitoring in the Gulf and provid ing technical expertise on the best approaches to remediate the oil spill, particularly bioremediatio n. This approach is especially important for oil t hat has moved into marshland. Some companies want to use “ super” microbes to deal with the oil and others want to optimize conditions to allow the indigenous microorganisms to clean up the oil. This latter approach appears to be the growing consensus. Ther e are concerns about people trampling nesting areas during remediation efforts and doing more damage to the ecosystem. EPA will be receiving supplemental funding of $2 million to be used for engaging insti tutions along the Gulf in conducting research to lo ok at the longer term impacts of the spill.

Dr. Sayler thanked Mr. Kadeli for his comments and asked if the BOSC members had any questions.

Dr. Philbert said that he found it bewildering that the taxpayers should have to pay for this testing. The testing should be funded with money set aside from the restitution funds. Mr. Kadeli responded that BP has committed to provide at least $50 million for r esearch on the long-term effects of the spill; it i s important for the Federal Government to be involved in this research. Dr. Philbert stated that he did not
think BP should do that research. He then asked if BP had required response workers to sign a waiver concerning any health impacts associated with respo nding to the spill. Mr. Kadeli replied that he did not have information on any such waiver. He added that the exposure of workers and their health are of concern. There have been discussions about engagin g the National Academies to look at the exposure and health issues so that there is an independent g roup of experts making this assessment and reportin g to
the Federal Government.

Dr. Philbert noted that the use of dispersants has been substantially reduced, and most of the oil is staying in the subsurface where the water is cold. Is anyt hing known about accumulation of oil and associatedBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 40 pollutants in benthic organisms and their effects o n the food chain? Will EPA be examining this issue ? Mr. Kadeli responded that both the oil and the disp ersants are toxic, but there is a tradeoff being ma de and the experts think it is less risky to use the dispe rsants. With regard to the question about accumula tion in benthic organisms, NOAA and the U.S. Fish and Wildl ife Service are examining the implications to organisms in the water column, however, more work n eeds to be done before the effects are understood. For example, they are finding oil under the shells of blue crabs in the Gulf but it is not clear if th is oil is coming through the crab’s digestive system. In add ition, it is not certain that the oil being detecte d is from the BP spill. More work needs to be done on b ioavailability, especially with dispersant use, and the focus should be on the lower organisms in the food chain.

Dr. Demerjian asked if there was any monitoring alo ng the shore for hydrocarbon species. Are they looking for semi-volatile organic compounds (SVOCs) that may have a role in aerosol formation? Is there anyone trying to measure the flux of emission s from the surface plumes and the burden this is to the background hydrocarbon levels? Mr. Kadeli replied that there is sampling for VOCs but he was not certain about SVOCs. There is air sampling and tes ting all around the coastal area. He was not aware of any samples that exceeded the normal background lev els of air toxics for the Gulf area. Dr. Demerjian encouraged the collection of data to measure the fl ux of the air emissions at the plumes. EPA and oth ers will want these data when they are working on the m odeling.

Dr. Haas commented that accidents are research oppo rtunities. NSF has a mechanism in place to conduct

research on little notice when these events occur. EPA does not have a similar mechanism that can be used to engage extramural researchers rapidly. Per haps the Agency should consider setting aside some funding for such circumstances. Mr. Kadeli replied that EPA has had discussions with NSF about utilizing NSF’s mechanism to do research. EPA coul d use that mechanism. He added that EPA’s research budget for oil-related issues had been onl y $500K to $700K per year for the last 5-6 years. Therefore, EPA had very limited resources available to address this issue. In addition, the Agency is trying to address potential issues associated with biofuels.



### Public Comments Dr. Gary Sayler, University of Tennessee, BOSC Exec utive Committee Chair

At 10:15 a.m., Dr. Sayler asked if anyone wished to make a public comment. No comments were offered.

Mr. Susanke confirmed that no one had contacted him by e-mail or telephone to request time for public

comment.



### BOSC and SAB Liaison Update Dr. Gary Sayler, University of Tennessee, BOSC Exec utive Committee Chair

Dr. Sayler stated that in the past there has been a n SAB member who served as the liaison to the BOSC. There currently is no liaison; Dr. John Giesy, a fo rmer member of the BOSC Executive Committee, has

volunteered to serve as the liaison to the BOSC but that has not been approved yet by Dr. Vanessa Vu.

The SAB has invited the BOSC to participate in any activity that may be of interest. The only stipula tion

is that the BOSC member who attends the SAB activit y must report back to the Executive Committee on what transpired.

Dr. Hauchman said that Mr. Susanke will follow up w ith Dr. Vu to get a status report on the appointmen t of a new liaison. Dr. Sayler said that, in the abs ence of a new liaison, he had been trying to keep t he SAB

informed of the activities of the BOSC. The work o f the Decision Analysis Workgroup has dovetailed nicely with the efforts of the SAB on decision maki ng. The SAB had interviewed the regional and headquarters staff about decision making, and Dr. S ayler participated in an SAB meeting at which this was a central topic. He alerted the SAB about the B OSC Workgroup’s efforts and informed them of theBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 41 report from that Workgroup. He agreed to share tha t report with the SAB. Mr. Susanke prepared a synopsis of the salient features of the report and informed the SAB that it fits well with its recent hydraulic fracturing report. The SAB decided to re ference the BOSC’s decision analysis report in the hydraulic fracturing report and suggested that EPA consider decision analysis techniques in establishi ng research priorities.

Dr. Sayler mentioned that he also serves on the SAB ’s Committee on Science Integration for Decision Making, which is preparing a report. He noted that Drs. Ryan and Haas also serve on the SAB, and can

share information on their SAB involvement. He ask ed the Executive Committee members to notify him and Mr. Susanke if they are interested in participa ting in an SAB activity. Dr. Sayler mentioned that the

mission of the BOSC is different from that of the S AB, but there are some activities that are of mutua l

interest.



### Future Business/Open Forum Dr. Gary Sayler, University of Tennessee, BOSC Exec utive Committee Chair

Dr. Sayler informed the BOSC members that the next Executive Committee meeting would be held in Washington, DC, probably in early to mid-October. After some discussion, it was decided that October 18-19, 2010, would be the best dates for the next m eeting.

There is a program review of the Land Research Prog ram coming up. Dr. Ryan has agreed to chair that Subcommittee, and Dr. Sayler thought it would be go od experience for one of the new Executive

Committee members to serve as the co-chair for that Subcommittee. The BOSC needs to prepare a short response to the mid-cycle progress reports from the SP2 and HHRA Research Programs. Dr. Sayler suggested discussing these responses on a conferenc e call in late August.

Dr. Sayler indicated that the BOSC wants to continu e its discussion of informatics and data mining at the October meeting in Washington, DC. He asked Drs. P hilbert and Haas to work with him to identify some knowledgeable presenters for the October meeting. Mr. Susanke suggested tailoring the presentations toward ORD’s needs. Dr. Haas suggested that knowle dge repositories be a topic for the Washington meeting. Dr. Sayler said he was looking at what th e Department of Energy has been doing to use technology to integrate information across many dif ferent scales. He thought it might be helpful to b ring several different experts to the October meeting to discuss these various activities. Dr. Philbert st ated that

another area to address is how to use old data with new frameworks—cross-platform continuity and compatibility. Dr. Sayler mentioned that bibliomet ric analysis is another topic for the October meeti ng. The BOSC has struggled with how to discriminate bet ween intramural and extramural researchers; he noted that the National Research Council (NRC) repo rt suggested that the program be considered as a

whole—not divided between intramural and extramural . There have been arguments, however, to support both opinions.

Dr. Sayler mentioned that another issue to consider is how ORD makes its scientific capabilities avail able to the regions. An upcoming SAB report will reflec t the regions’ view that ORD is not providing the support that they need.

Dr. Haas said that the Drinking Water Subcommittee probably will not have a draft report ready for the October meeting. The face-to-face review meeting w ill likely take place in September or October.

Dr. Hauchman asked the Executive Committee members to share their views on how the BOSC could assist with ORD’s technical support issue. Histori cally, the BOSC has not dealt with the issue of technical support and the loop back to inform resea rch. There is value in conducting a needs assessme nt and dealing with the tension between the need for t echnical support and the research that the ORD staf f

wants to do. Dr. Hauchman noted that ORD would wel come the BOSC’s input on this task.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 42 Dr. Sayler asked that the BOSC be allowed to provid e input early in this effort. He pointed out that it falls within the Board’s purview and comes up at ev ery program review. Dr. Demerjian commented that it is one of the charge questions and most subcommi ttees have found it difficult to answer. Dr. Hauch man stated that the BOSC will hear more about this in t he review of the Land Research Program.

Referring back to the issue of bibliometrics, Dr. P hilbert stated that the NCER Standing Subcommittee pointed out in its last report that academic biblio metrics—impact factors and immediacy indices—are no t that helpful to ORD. It is more important for ORD to determine how the research outputs have impacted public health through regulations, policies, guidan ce, and similar means. Dr. Haas commented that the

BOSC has been conditioned to look at outcomes rathe r than outputs. The NRC report noted that outcomes are very difficult to measure; therefore, ORD needs to look for early markers of outcomes tha t predict the outcome is likely. Dr. Cozzens mention ed that the term used in that report for these earl y markers was “intermediate outcomes,” and that conce pt is now widely accepted.

Dr. Sayler said that there will be plenty of topics for discussion on the August teleconference and at the October meeting. Mr. Susanke thought it might be n ecessary to postpone some of the topics to a future meeting. Dr. Sayler asked if it would be possible to postpone the presentation on the SPSW Program, a nd Mr. Susanke replied that the program has made a lot of progress and would like the BOSC to consider forming a standing subcommittee to provide ongoing advice. It may take 6 months to form the subcommittee so it would be best not to postpone th at presentation. Drs. Philbert and von Stackelberg indicated that they would like to serve on that sub committee. Mr. Susanke said that he would be worki ng on forming a subcommittee. Dr. Sayler asked if the ORD response to the decision analysis report would be ready for the October meeting, and Mr. Susanke i ndicated that ORD will try to have a response ready

.

Dr. Hauchman indicated that he had to leave soon bu t he wanted to thank the BOSC members for their time and input. Referring to Dr. Olden’s early com ment about the importance of ORD responding to the BOSC’s recommendations, he emphasized that ORD valu es the input and he has been impressed with how many changes have been implemented by programs as a result of the BOSC reviews.

Dr. Sayler said that he was a guest observer on the Nanomaterial Case Study review. He noted that thi s was a perfect opportunity for the decision analysis pilot.



### BOSC Decision Analysis Workgroup—Review of ORD Nano material Case Study Workshop: Methods and Procedures to Identify and P rioritize Research Needs
Dr. Mike Davis, Senior Science Advisor, NCEA, ORD, EPA

Dr. Davis explained that ORD wanted to identify nan omaterial research needs and directions and refine a strategic approach for establishing priorities. Th ey took a bottom-up approach, looking at specific applications. The case studies are not an end in t hemselves, but a starting point for a collective ju dgment process. The case studies were used to identify qu estions that would need to be addressed if they wer e doing a Comprehensive Environmental Assessment (CEA ). The case studies are not completed risk assessments but are structured around a CEA approac h, which combines a product life cycle framework with the risk assessment paradigm. The CEA approac h considers primary and secondary contaminants, multiple environmental media, fate and transport pr ocesses, cumulative and aggregate exposure, and ecological as well as human health risks across the life cycle of a product. The features of the CEA framework approach include:

 Holistic and systematic, not just a checklist

 Qualitative and quantitative

 Primary and secondary substances

 Single, cumulative, and aggregate exposureBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 43  Direct and indirect impacts

 Comparative—alternative choices and risks vs. benef its.

This approach provides guidance to risk managers (h ighlighting tradeoffs, focus on monitoring and mitigation, and adaptive management). In addition, the CEA framework approach can be used to identify information gaps and priorities. Dr. Davis mention ed that there is confusion about life cycle assessm ent (LCA) and CEA. He noted that CEA is more qualitativ e than LCA. CEA, as a process, uses collective judgment and involves diverse perspectives (multidi sciplinary, multi-stakeholder). It also involves a substantial number of participants, avoids arbitrar y boundaries, and is iterative.

The key questions for the nanomaterial case studies were: What do we know? and What do we need to

know to be able to do a CEA of nanomaterials? Nano scale titanium dioxide (nano-TiO 2 ) and nanoscale silver (nano-Ag) were selected for the case studies . Case Study #1 focused on nano-TiO 2 for water treatment, Case Study #2 focused on nano-TiO 2 in sunscreen lotion, and Case Study #3 focused on nanoAg in disinfectant spray.

The EPA Nanomaterial Case Study Workshop was held S eptember 29-30, 2009, in Research Triangle Park, North Carolina. Diverse technical and stakeho lder perspectives were represented. Fifty particip ants were invited and they were balanced across sectors (academia, government, industry, NGOs, and other) and disciplines (technical, scientific, policy, and other). There was a pre-workshop review and ranki ng of research/information needs. Nominal Group Techniqu e (NGT) was used to rank priority research needs. Participants identified and prioritized research ne eds for: (1) specific applications of nano-TiO 2 , (2)

nano-TiO 2 regardless of application, and (3) nanomaterials i n addition to nano-TiO 2

.

NGT is a method that enables a set of persons to id entify and rank choices. NGT’s typical features include: (1) each individual is allowed the same a mount of time to state his/her highest priorities, (2) the number of participants is up to ~25 per group, (3) facilitators guide consolidation of similar or rela ted priorities, and (4) there is multi-voting for the 1 0 highest priorities. For the EPA workshop there w ere two NGT groups, each with 25 members. The two NGT groups’ priorities were consolidated, and breakout groups (5 members per group) prepared narr atives on the top priorities.

The top-ranked issues using NGT were:

 Approaches and methods for evaluating the ecologica l and human effects of nano-TiO 2

.
 Physicochemical characterization of nano-TiO 2 throughout the life cycle stages, environmental pathways, and fate and transport.

 Analytical method evaluation, development, and vali dation for analysis of nano-TiO 2 in relevant

matrices.

 Nano-TiO 2 product-focused physicochemical characterization; changes and possible effects through the life cycle.

 Exposure pathways and life cycle stages.

 Spatial and temporal distribution and magnitude of anthropogenic and non-anthropogenic nanoTiO 2 in the environment.

 Using mechanism of action (MOA) information to driv e toxicity testing.

 Long-term effects.

Dr. Davis mentioned that eight top issues emerged t hrough the NGT process and the distribution of vote s by the workshop participants (rather than just pick ing an arbitrary number such as 10). He summarized the top issues in terms of three prominent themes ( not necessarily in rank order):BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 44  Physicochemical characterization

• Identify key properties

• Develop/apply methods

• Relate to life cycle stages, fate and transport, ma trices, exposure, effects

 Effects characterization (ecotoxicity, human health )

• Standardize/harmonize test protocols for acute, sub acute, and chronic studies

• Reference materials

• Mechanisms

 Exposure characterization

• Sources/life cycle stages, pathways, routes

• Typical and atypical (high-end)

• Environmental spatial/temporal distribution, backgr ound levels, natural vs. anthropogenic, bioaccumulation.

Dr. Davis closed his presentation with some of the lessons learned from the 2009 workshop. The questions and research needs could have been refine d and one, smaller NGT group of 25 to 30 members could have been used. More formal “argument” could have been encouraged and there could have been less consolidation of issues. In addition, mid-lev el priorities could have received more focus and

additional time could have been allocated to the br eakout group session.

Dr. von Stackelberg explained that the BOSC Decisio n Analysis Workgroup was asked to review the Nanomaterial Workshop Report and comment on the pro cess that was used to identify priority research

needs. She reminded the Executive Committee member s that nearly 2 years ago, ORD indicated that it was interested in using VOI or a similar decision a nalytic approach to help in identifying research ne eds and priorities. The BOSC formed a workgroup to dis cuss this topic and, in conjunction with the Nation al Risk Management Research Laboratory (NRMRL), conven ed a workshop to discuss the topic. The workshop included representatives from other federa l agencies and academia as well as private consultants. The report prepared by the workgroup following that workshop included nanomaterials as

one of the case studies.

Dr. von Stackelberg indicated that the workgroup wa s asked to review the process that is described in the Nanomaterial Case Study Report rather than the outc omes (the priorities identified). She noted that decision analysis approaches are used to make the d ecision-making process more transparent and to arri ve at better decisions; however, it is not always easy to implement these approaches.

Dr. von Stackelberg stated that NGT may have worked for ORD in this case study and the group may have arrived at the desired outcomes (a list of pri ority research needs); however, NGT, as a process, falls short of the BOSC Workgroup’s expectations to quant itatively, rigorously assess how research is allocated and the tradeoffs being made by funding p roject “x” rather than project “y.” There is a lot that is not addressed by NGT. In the mid-1980s, there w ere numerous exercises to link NGT with more formal decision analysis methods. Our understandin g of optimization in the mathematical sense has increased dramatically since 2005, so now there are many tools available for formal decision analysis, but analysts often do not know how to use them.

Dr. von Stackelberg said that she recently attended a meeting on the SPSW Program where the attendees talked about employing some formal decision analysi s method that goes beyond NGT. She mentioned that although the nanomaterials case study was used at the decision analysis workshop, not much was done with it because of the different opinions with in those attending the workshop. She added thatBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 45 research on nano-TiO 2 as a sunscreen agent will be different from resear ch on nano-TiO 2 for water treatment. The case studies help EPA figure out th e important questions that need to be addressed.

If ORD’s ultimate goal is to develop a broad long-r ange strategy for formal decision analysis, then perhaps ORD should convene a workshop on comprehens ive evaluation frameworks to develop a decision tree, which indicates that “x” has to be d one before “y” can be started. This may be a bette r approach than using the case studies. The NGT proc ess helped ORD prioritize the research questions/issues but it did not identify what resea rch needs to be done or what ORD needs to get from that research. Dr. von Stackelberg said she had trouble transferring the ranked questions into research priorities.

Dr. Sayler asked Dr. von Stackelberg to submit her comments on the Nanomaterial Case Study Workshop Report in writing. Dr. von Stackelberg replied tha t she had prepared a formal response to distribute to the

Executive Committee for comment.

Dr. Philbert said that it is important to remember that “perfect is frequently the enemy of good.” Th e report was exactly what he would expect to achieve from the process. The group identified the top eig ht

issues that EPA should address for these case studi es. The process worked and it resulted in valuable information. Now, ORD should consider doing a seco nd workshop to identify the research that needs to be done to address these priority needs. Dr. von S tackelberg agreed that the workshop was a great fir st step, but she thought ORD could go further. Dr. Ha as thought it was a good brainstorming session to identify a list of priority needs. Now, ORD needs to determine what tasks need to be done, how much those tasks will cost, and how each task helps answ er the underlying questions. That will move ORD beyond the NGT process and toward finding the answe rs it is seeking.

Dr. von Stackelberg agreed to send her draft respon se to the workshop report. Dr. Sayler stresssed th e need to specifically mention the prioritized resear ch needs. Dr. Philbert said he could provide comme nts on the list of priorities developed at the workshop . Dr. von Stackelberg did not think the BOSC was supposed to comment on the priorities, just the pro cess. Mr. Susanke said that the BOSC needs to comment on the workshop priorities which are in ess ence the workshop recommendations. Does the BOSC agree that these are the top priorities? Dr. Philbert replied that he would have no difficulty providing such input.

Dr. Demerjian asked if water treatment and sunscree n lotion were the two major uses of nano-TiO 2 or if there were many other uses. Dr. Davis responded th at the majority of nano-TiO 2 is not going into these two uses, but it is difficult to obtain information on all the different applications. It was difficu lt to find

information on its use in water treatment and it tu rns out that nano-TiO 2 is not being used in this application. Dr. Philbert thought these two applic ations were appropriate in that they impact the

environment and data are available. Dr. Davis ment ioned that ORD wants to use this approach with coating materials and extend it to carbon nanotubes

.

Dr. Cozzens said that she would have expected to se e much more input from worker organizations and consumers at the workshop; however, it does not app ear that these folks were invited to participate. Dr. Davis responded that they tried to include that input through representatives of labor unions and consumers unions, as well as worker safety represen tatives. Dr. Sayler commented that the workshop included a very diverse group and ORD made a concer ted effort to ensure reasonable stakeholder representation. Dr. Davis added that they tried to get NGOs involved as well. Dr. Cozzens stressed t hat the groups to be affected need to be involved in th e process. Dr. Philbert pointed out that Appendix E of the report identifies the workshop participants. T here are a number of individuals from consumer protection groups as well as representatives from N IH and FDA. It may not be a complete list but it i s very good from EPA’s perspective.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 46 Dr. Sayler thought the response from the BOSC shoul d identify any weaknesses of the process and make suggestions for improving it. Dr. Tharakan asked i f ORD is seeking the BOSC’s approval of the process

. Dr. Sayler replied that the BOSC is acknowledging t hat a verified process was used at the workshop and that it yielded bona fide results. Dr. Tharakan th en asked if the report will identify the weaknesses of the process as well. Dr. Sayler confirmed that it woul d. Dr. Cozzens asked about the baseline. Dr. von Stackelberg responded that the baseline would be a group of people coming together and making a decision using no process. She noted that with NGT it is important to ensure that there are no domina nt
voices.

Dr. Sayler asked Drs. von Stackelberg and Philbert to communicate and move the response forward within the next few days. Dr. Philbert asked the E xecutive Committee members to e-mail their comments on the workshop report to him so that he can incorp orate them into a draft BOSC EC response.

Dr. Sayler explained that there would be an informa l discussion with representatives of GAO immediatel y following the BOSC meeting. In addition, the aftern oon would include a field study tour. He thanked t he members for their participation and adjourned the E xecutive Committee meeting at 12:20 p.m.



### Action Items

 Mr. Susanke will follow up with Dr. Vanessa Vu abou t the status of appointing a new liaison from the SAB to the BOSC. Specifically, he will determine i f a decision has been made about Dr. John Giesy serving as the liaison.

 Executive Committee members will notify Mr. Susanke and Dr. Sayler if they would like to participant in any of the upcoming SAB activities.

 Dr. Sayler will work with Drs. Philbert and Haas to identify knowledgeable presenters on informatics and data mining for the October meeting in Washingt on, DC.

 Dr. Ryan will draft a response from the BOSC—a shor t summary of the Executive Committee’s comments—on the mid-cycle progress report for the S P2 Research Program.

 Dr. Sayler will draft a response from the BOSC – a short summary of the Executive Committee’s comments – on the mid-cycle progress report for the HHRA Research Program.

 Dr. von Stackelberg will send her draft response on the Nanomaterial Case Study Workshop Report to Dr. Philbert and Mr. Susanke by July 16, 2010. Mr. Susanke will distribute the draft response to

the Executive Committee for review and comment.

 Mr. Susanke will schedule a conference call in late August to discuss and approve the BOSC responses to: 1) the mid-cycle progress report for the SP2 Research Program; 2) the mid-cycle progress report for the HHRA Research Program; and, 3) the nanomaterial workshop summary.

 Mr. Susanke will distribute materials to the Execut ive Committee to be discussed on the August

conference call.



### 1
2
3
4 All materials that were transmitted during and for this meeting are in the public meeting binder in the BOS C

central files in Washington, DC.BOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 47 Executive Committee Members :

Gary S. Sayler, Ph.D., Chair Center for Environmental Biotechnology The University of Tennessee

Susan Cozzens, Ph.D. School of Public Policy Georgia Institute of Technology

Kenneth L. Demerjian, Ph.D. Atmospheric Sciences Research Center State University of New York

Henry Falk, M.D., M.P.H. (not present) Coordinating Center for Environmental Health and Injury Prevention

Centers for Disease Control and Prevention

Charles N. Haas, Ph.D. Department of Civil, Architectural, and Environmental Engineering Drexel University

Kenneth Olden, Ph.D., Sc.D., L.H.D.

School of Public Health City University of New York

Dennis Paustenbach, Ph.D., CIH, DABT (not present) ChemRisk, Inc.

Martin Philbert, Ph.D. Department of Environmental Health Sciences

School of Public Health University of Michigan

P. Barry Ryan, Ph.D. Department of Environmental and Occupational

Health

Rollins School of Public Health Emory University

Katherine von Stackelberg, Sc.D . (via telephone) Harvard Center for Risk Analysis

Harvard School of Public Health John Tharakan, Ph.D. College of Engineering, Architecture, and Computer Science College of Medicine Howard University

Marie Zhuikov, M.A.

Private Communications Consultant

Committee Staff :

Greg Susanke, DFO U.S. Environmental Protection Agency Office of Research and Development Office of Science Policy

Heather Drumm (via videoconference) U.S. Environmental Protection Agency Office of Research and Development Office of Science Policy

Kevin Teichman, Ph.D. (via videoconference) U.S. Environmental Protection Agency Office of Research and Development

EPA Participants :

Paul Anastas, Ph.D. (via videoconference) U.S. Environmental Protection Agency Office of Research and Development

Stan Barone (via videoconference) U.S. Environmental Protection Agency Office of Research and Development

Renée Brooks, Ph.D. U.S. Environmental Protection Agency Office of Research and Development

Becki Clark (via videoconference) U.S. Environmental Protection Agency Office of Research and Development

Sally Perrault Darney, Ph.D. (via videoconference) U.S. Environmental Protection Agency Office of Research and Development 

## P ARTICIPANTS 

## L ISTBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 48 Mike Davis, Ph.D. U.S. Environmental Protection Agency Office of Research and Development

Joe Ebersole, Ph.D. U.S. Environmental Protection Agency Office of Research and Development

Tom Fontaine, Ph.D. U.S. Environmental Protection Agency Office of Research and Development

Elaine Francis, Ph.D. (via videoconference) U.S. Environmental Protection Agency Office of Research and Development

Tom Griffin U.S. Environmental Protection Agency Office of Research and Development

Carry Hamilton U.S. Environmental Protection Agency

Public Health Fellow

Fred Hauchman, Ph.D. U.S. Environmental Protection Agency Office of Research and Development

Lek Kadeli (via videoconference) U.S. Environmental Protection Agency Office of Research and Development

Bob Kavlock, Ph.D. (via videoconference) U.S. Environmental Protection Agency 

### Office of Research and Development

Steve Klein U.S. Environmental Protection Agency Office of Research and Development

Steve Knowles U.S. Environmental Protection Agency Office of Research and Development

Henry Lee II, Ph.D. U.S. Environmental Protection Agency Office of Research and Development Jeff Morris (via videoconference) U.S. Environmental Protection Agency Office of Research and Development

Bob Ozretich, Ph.D. U.S. Environmental Protection Agency Office of Research and Development

Dale Pahl U.S. Environmental Protection Agency Office of Research and Development

Don Phillips, Ph.D. U.S. Environmental Protection Agency Office of Research and Development

Lidia Watrud, Ph.D. U.S. Environmental Protection Agency Office of Research and Development

Denis White U.S. Environmental Protection Agency Office of Research and Development

Joe Williams (via telephone) U.S. Environmental Protection Agency Office of Research and Development

Other Participants :

Tom Dietterich, Ph.D. Oregon State University

Julia Jones, Ph.D. Oregon State University

Summer Lingard Government Accounting Office

Nadia Rhazi Government Accounting Office

Enrique Thomann, Ph.D. Oregon State University

Ed Waymire, Ph.D. Oregon State UniversityBOSC E XECUTIVE C OMMITTEE J ULY 12-13, 2010, M EETING S UMMARY



### 49 Contractor Support :

Beverly Campbell The Scientific Consulting Group, Inc.

Denise Hoffman The Scientific Consulting Group, Inc.

### 50 44th EXECUTIVE COMMITTEE FACE-TO-FACE MEETING

AGENDA July 12 - 13, 2010

Office of Research and Development

National Health and Environmental Effects Laborator y

Western Ecology Division

200 SW 35 th

Street, Corvallis, Oregon 97333

Monday, July 12, 2010

8:30 a.m. – 9:00 a.m. Registration

9:00 a.m. – 9:20 a.m. Welcome and Introductions Dr. Gary S. Sayler, Chair, - Review of April Executive Committee Meeting Minutes - Overview of Agenda

9:20 a.m. – 9:30 a.m. BOSC DFO Remarks Mr. Greg Sus anke, - Administrative Issues Designated Federal Officer (DFO),

Office of Research and Development (ORD)

9:30 a.m. – 9:45 a.m. Overview of ORD Chemical Dr. Bob Kavlock, Director Research Realignment: Safe National Center for Products for a Sustainable World Computational Tox icology,

ORD

9:45 a.m. – 10:45 p.m. Mid-Cycle Progress Report Dr . Stan Barone, - Human Health Risk Assessment National Program Di rector, Research Program, ORD



### 10 :45 a.m. – 11:00 a.m. Break

11:00 a.m. – 12:00 noon Mid-Cycle Progress Report D r. Elaine Francis, - Safe Pesticides/Safe Products National Program D irector, Research Program ORD

12:00 noon – 1:00 p.m. LunchAgenda for July 12-13, 2010 Executive Committee Mee ting



### 51 1:00 p.m. – 3:00 p.m. Ecosystem Informatics Session - Overview Ecosystem Informatics Dr. Julia Jones, Director Program Oregon State University (OSU)

- Computer Science Approaches Dr. Tom Dietterich

, to Species Modeling OSU

- Mathematics of Ecological Dr. Ed Waymire, OS U 

### Dispersion and

Dr. Enrique Thomann,

OSU - Questions and Discussion

3 :00 p.m. – 5:00 p.m. Lab Tour: Western Ecology Div ision,

National Health and Environmental Research Laboratory, ORD

5:00 p.m. Recess

Tuesday, July 13, 2010

8:30 a.m. – 9:15 a.m. 

### ORD Response to BOSC Human Dr. Sally Perrault Dar ney, Health Report National Program Director for Human Health, ORD

9:15 a.m. – 10:00 a.m. ORD Update Dr. Kevin Teichm an, Deputy

Assistant Administrator for Science, ORD

10:00 a.m. – 10:15 a.m. BOSC and SAB Liaison Upda te Dr. Gary Sayler, Chair

Executive Committee

10:15 a.m. – 10:30 p.m. Public Comment

10:30 a.m. – 10:45 a.m. Break

10:45 a.m. – 12:30 p.m. BOSC Decision Analysis Wor kgroup 

### Dr. Katherine von Stackelberg,

- 

### Review of ORD Nanomaterial Workgroup Chair, Executive 

### Case Study Workshop: Committee



### Methods and Procedures to Identify and Prioritize Research Dr. Mike Davis, Needs Senior Science Advisor,

National Center for Environmental Assessment,

ORDAgenda for July 12-13, 2010 Executive Committee Mee ting



### 52 12:30 p.m. – 1:00 p.m. Future Business/Open Forum D r. Gary Sayler, Chair, - Next EC Meeting Executive Committee

- Future Work - Questions/Discussion

1:00 p.m. Adjourn