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

### B OARD OF 

### S CIENTIFIC 

### C OUNSELORS 

### (BOSC)

E XECUTIVE 

### C OMMITTEE



### Conference Call Summary Wednesday, August 25, 2010 1:00 p.m. – 3:00 p.m. Eastern Time

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

Dr. Gary Sayler, Chair of the Board of Scientific C ounselors (BOSC) Executive Committee, welcomed

the Committee members to the teleconference and too k roll. A list of the Executive Committee members and others who participated in the call is attached

.

Overview of Agenda

Dr. Sayler explained that the primary purpose of th is call was to review and approve the BOSC’s responses to two mid-cycle progress reports and the Nanomaterial Case Studies Workshop Report. He then reviewed the agenda for the call, which includ ed the remarks of the Designated Federal Officer (DFO), and discussion and approval of the BOSC resp onses to the Safe Pesticides/Safe Products (SP2) Mid-Cycle Progress Report, the Human Health Risk As sessment (HHRA) Mid-Cycle Progress Report, and the Nanomaterial Case Studies Workshop Report. The agenda also included time for public comment

and a discussion of future business.



### BOSC Designated Federal Officer (DFO) Remarks Mr. Greg Susanke, U.S Environmental Protection Agen cy (EPA)/Office of Research and Development (ORD), DFO

Mr. Greg Susanke, DFO for the BOSC Executive Commit tee, thanked the BOSC members for their participation and reviewed the Federal Advisory Com mittee Act (FACA) procedures that are required for all BOSC meetings. In accordance with FACA, all BO SC meetings and conference calls are open to the public, and as the DFO, Mr. Susanke ensures that al l FACA requirements are met. A notice for this conference call was published in the Federal Register on August 6 in accordance with FACA, and an

electronic docket was established. The docket is a vailable at http://www.regulations.gov , and the docket number is EPA-HQ-ORD-2010-0661; the agenda for the call was posted on that site.

Per FACA requirements, a record of Board deliberati ons must be made available to the public. Therefor e, notes of the conference call are being taken by a c ontractor, Beverly Campbell of The Scientific Consulting Group, Inc., who will prepare a summary of the conference call. Following review of the summary by the Executive Committee members and cert ification by the Chair, it will be made available to the public in the docket and on the BOSC Web Sit e ( http://www.epa.gov/osp/bosc ).

As the DFO, Mr. Susanke has worked with EPA officia ls to ensure that appropriate ethics regulations

have been satisfied and that the Executive Committe e members have completed the ethics training for special government employees. He asked that Execut ive Committee members inform him if they discover a potential for conflict of interest that would affect their impartiality regarding any of th e topicsE XECUTIVE C OMMITTEE A UGUST 25, 2010, C ONFERENCE C ALL S UMMARY

2 under discussion during the call. Mr. Susanke rece ived 10 requests for the agenda and call-in number but there were no requests for public comment submitted prior to the call; nevertheless, there is time set aside on the agenda for public comment following the disc ussion of the BOSC response to the Nanomaterial Workshop Report. Mr. Susanke asked that public com ments be limited to 3 minutes each. He noted that the July meeting summary would have to be approved at the October meeting because he was awaiting comments from the various speakers before sending i t to the Executive Committee.

Mr. Susanke stated that the government fiscal year ends on September 30, and he has to account for the BOSC’s expenditures by that date. Therefore, he re quested that all Executive Committee members submit their homework sheets to him as soon as poss ible so that he can get those processed in the next

few weeks.



### BOSC Response to the SP2 Mid-Cycle Progress Report Dr. Barry Ryan, Emory University, BOSC Executive Co mmittee Member

Because Dr. Barry Ryan served as the Vice Chair of the SP2 Subcommittee that conducted the review of the program in 2007, he drafted the BOSC’s response to the SP2 Mid-Cycle Progress Report that was distributed to the Executive Committee prior to thi s call. The draft included discussions by the Exec utive Committee made during the July 12, 2010 meeting,

Dr. Ryan stated that Dr. Elaine Francis, National P rogram Director (NPD) for the SP2 Research Program, did a nice job presenting the mid-cycle progress re port at the July meeting. All 22 recommendations f rom the 2007 program review were addressed in the progr ess report. He noted that the SP2 Program will be

subsumed under the new Safe Products for a Sustaina ble World (SPSW) Research Program, which was described at the July meeting in Corvallis. Theref ore, he did not think it was necessary for the BOSC to comment on the program’s response to each of the re commendations. Another significant change since the 2007 program review was that Long-Term Goal (LT G) 3 was recast and the funding for that research was allocated to other parts of the Agency; as a re sult, the SP2 Research Program is no longer conduct ing

that research.

In summary, Dr. Ryan said that the program has been doing a good job and he expects that they will continue to do a good job when the work is moved un der the new SPSW Research Program.

Dr. Sayler asked if there were any comments, issues to discuss, or edits to the BOSC’s response. When no comments were offered, Dr. Sayler called for a m otion to approve the response to the SP2 Mid-Cycle Progress Report for submission to the Office of Res earch and Development (ORD). Dr. John Tharakan moved to approve the response with no changes, and Dr. Dennis Paustenbach seconded the motion. The response was approved unanimously by the Executive Committee and it will be submitted to ORD with no changes.



### BOSC Response to the HHRA Mid-Cycle Progress Report Dr. Gary Sayler, BOSC Executive Committee Chair

Dr. Sayler explained that he had drafted the BOSC’s response to the HHRA Mid-Cycle Progress Report that was distributed to the Executive Committee pri or to the call. The progress report was presented by Ms. Becki Clark, Acting Director of the National Ce nter for Environmental Assessment (NCEA), at the July meeting in Corvallis. The draft BOSC response was based on the written comments that were prepared and submitted by Dr. George Daston, a form er member of the Executive Committee, who served

as the Chair of the HHRA Subcommittee that reviewed the program in 2007. Dr. Sayler thought the HHRA Research Program had made good progress since the BOSC program review and had responded to

most of the BOSC’s recommendations. He noted that the program had not fully responded to a staffing recommendation from the 2007 review, but there was no need for further BOSC activity on the issue unti l the next program review.E XECUTIVE C OMMITTEE A UGUST 25, 2010, C ONFERENCE C ALL S UMMARY

3 Dr. Tharakan asked if there was anything that the B OSC could do to assist the program in moving forward to address the recommendation of hiring mor e senior scientists. Dr. Sayler replied that there was little more that the BOSC could do to facilitate th is matter; the Board can only reiterate and strengt hen the comments made in the 2007 program review. Dr. Sayl er asked if there were any other comments on the response. Dr. Paustenbach said he thought the repo rt was remarkably thorough and that Ms. Clark’s presentation was very clear. Dr. Falk commented th at he thought it was a lucid mid-cycle progress rep ort.

Hearing no additional comments, Dr. Sayler called f or a motion to approve the response to the HHRA Mid-Cycle Progress Report with no changes. Dr. Rya n moved to approve the response, and Dr. Tharakan seconded the motion. The BOSC’s response to the HH RA Mid-Cycle Progress Report was approved unanimously by the Executive Committee, and it will be submitted to ORD with no changes.



### BOSC Response to Nanomaterial Workshop Report Dr. Katherine von Stackelberg, Decision Analysis Wo rkgroup Chair, BOSC Executive Committee

Member

Dr. von Stackelberg presented her thoughts on the N anomaterial Workshop Report at the July meeting in Corvallis. After that meeting, she prepared a draf t BOSC response to the workshop report based on her comments and the discussion at the July meeting. Th at draft was circulated to the other members of the Decision Analysis Workgroup and their comments were incorporated to generate the draft that was distributed to the Executive Committee prior to thi s call. Dr. von Stackelberg noted that the Decisio n Analysis Workgroup members were satisfied with the draft response and thought she had captured their comments appropriately. She then asked if there we re any comments on the draft response.

Mr. Susanke stated that this response will be submi tted to ORD as a BOSC letter report, so he asked Dr. Sayler to prepare a cover letter to accompany t he report. Dr. Sayler agreed to prepare the cover letter

and send it to Mr. Susanke.

Dr. Ryan indicated that he had some minor editorial corrections. In the third paragraph on page 1, th e last word in the fourth line should be changed to “way” rather than “sway.” Also, MCDA on page 3, second paragraph under the section titled “NGT as a Method for Prioritizing Research Investment Decisions,”

had not been defined.

Dr. Susan Cozzens commented that the wording in the first paragraph under the “NGT as a Method for Prioritizing Research Investment Decisions” section on page 3 is repeated from the third paragraph on page 1. She suggested that the paragraph on page 3 be reworded to avoid the redundancy. There are oth er paragraphs that are redundant as well. Dr. von Sta ckelberg agreed to do some wordsmithing to eliminat e the redundancies. Dr. Cozzens also suggested inser ting a period after “(US EPA, 2010)” in the first paragraph on page 1 to end the sentence there becau se the next phrase does not relate to the goal of t he workshop. She proposed inserting the words “The wo rkshop organizers” after the period to begin the next sentence. An additional comment was to change “(e.g., Corps)” to “(e.g., Army Corps of Engineers) at the end of the second line in the second paragra ph under the section titled “Background Information ” on page 2.

Dr. Sayler thought the report needed some clarifica tion so that the reader could distinguish between t he BOSC Decision Analysis Workshop, mentioned in the “ Background Information” section and the Nanomaterial Case Studies Workshop. It should be c lear that these were distinct and unrelated workshops so that there is no confusion.

Ms. Marie Zhuikov pointed out that there was an ext ra space between the words “For” and “example” in the first line of the last paragraph on page 3. She also noted that a space should be inserted between “and,” and “which” in the second line on the top of page 2.E XECUTIVE C OMMITTEE A UGUST 25, 2010, C ONFERENCE C ALL S UMMARY

4 Dr. Sayler stated that the report appears to need o nly minor editing so he proposed that Dr. von Stackelberg incorporate these changes and send a re vised letter report to both him and Mr. Susanke.

Mr. Susanke asked if the letter report could includ e some statement from the BOSC concerning the priorities that resulted from the Nominal Group Tec hnique (NGT) used at the Nanomaterial Case Studies Workshop. Dr. von Stackelberg responded that the g uidance provided by ORD indicated that the BOSC was to evaluate the process and not focus on the pr iorities. Mr. Susanke replied that there were char ge questions submitted to the BOSC, one of which conce rned the priorities. Dr. Sayler asked if Mr. Susan ke was asking the BOSC to comment on the priorities. Mr. Susanke answered that the BOSC needs to weigh-in on the validity and appropriateness of the priorities. Ms. Campbell asked Dr. von Stackelber g if she had received a comment on the priorities from D r. Martin Philbert, because that was an action item from the July meeting. Dr. Philbert confirmed that he did not provide any comments on the priorities following the July meeting. Dr. von Stackelberg st ated that the priorities seem to make sense and the y were developed using a valid process, even though O RD could have gone further. Dr. Philbert was not certain what more could be added to the letter repo rt with respect to the priorities. Dr. von Stackel berg noted that the report confirms that NGT is a valid process and that the outcomes should be better than if no process was used to identify priorities.

Dr. Sayler asked if the list of questions in the mi ddle of page 4 includes all of the priorities from the workshop. Dr. von Stackelberg said that she include d most of them. Dr. Sayler stated that from the BOSC’s perspective, the prioritized questions seem valid, but it is not clear how they translate into a research strategy. That is about all that the BOSC can say at this point. Mr. Susanke asked if the B OSC thinks the resulting list of prioritized questions makes sense given the process used at the workshop. Dr. Sayler responded that the report can be modifie d to include a statement about the priorities or it could

be addressed in the cover letter. Mr. Susanke thou ght it was important to include the statement in th e conclusions of the letter report. Dr. Sayler asked Dr. von Stackelberg to add a few lines that indica te the acceptability of the priorities. Dr. Tharakan sugg ested that the report recognize that the list of pr ioritized questions is dynamic and it will probably change as research progresses. Dr. Cozzens pointed out that the BOSC is not adopting these questions as the Executi ve Committee’s priorities in nanomaterials, but is recognizing them as a legitimate result of the work shop.

Dr. Sayler concluded the discussion by stating that the prioritized list of questions is legitimate bu t the list is dynamic and will change over time. The BOSC fun damentally agrees with the outcome of the workshop—the results achieved were a valid output o f the process. He asked Dr. von Stackelberg to incorporate such a statement into the conclusions o f the revised letter report. She also will incorpo rate the editorial changes suggested by the Executive Commit tee. Dr. Tharakan asked if the original request to the BOSC asked the Board to comment on the prioriti zed list. Dr. Sayler responded that he did not thi nk the BOSC could make any suggestions about what prio rities would be more appropriate than those identified at the workshop. Mr. Susanke said the a ddition of the statement described by Dr. Sayler wo uld satisfy his concerns regarding the report. Dr. von Stackelberg pointed out that the priority question s are specific to one area, but there may be a better pro cess that would yield priorities that could be gene ralized

to other areas. ORD cannot afford to hold a worksh op on every issue to identify a list of priorities.

Dr. Tharakan stressed the need to make it clear tha t the priorities from the workshop relate to specif ic nanomaterials in specific applications, and that th e list is dynamic and might change as research resu lts become available. Dr. von Stackelberg noted that t he list also could change if ORD looks at different applications of these nanomaterials. Perhaps a dec ision tree to answer a set of questions may be more useful. Dr. Sayler thought the report did a good j ob of addressing that suggestion.

Dr. Sayler called for a motion to approve the lette r report on the Nanomaterial Case Studies Workshop with the suggested changes. Dr. Philbert made a mo tion to approve the report, and Dr. Cozzens seconde d the motion. The report was approved unanimously by the Executive Committee with the suggested changes.E XECUTIVE C OMMITTEE A UGUST 25, 2010, C ONFERENCE C ALL S UMMARY

5 Dr. von Stackelberg agreed to submit the revised le tter report to Dr. Sayler by Friday, August 27. Dr. Sayler will confirm that the changes have been made, prepare a cover letter, and submit them both to Mr. Susanke before September 6.



### Public Comment Dr. Gary Sayler, BOSC Executive Committee Chair

Dr. Sayler called for public comments at 2:45 p.m. No comments were offered.



### Future Business Dr. Gary Sayler, BOSC Executive Committee Chair

The next face-to-face BOSC Executive Committee meet ing will be held Monday and Tuesday, October 18-19, 2010, in Washington, DC. Dr. Sayler said he had seen a draft agenda for that meeting, which wi ll include a session with speakers on knowledge bases, informatics, and bibliometrics. Mr. Susanke indicated that the meeting will begin at 8:30 a.m. on Monday morning and will probably end around 1:00 p.m. on Tuesday.

Dr. Sayler mentioned that the October meeting will be his last meeting as the BOSC Chair and it will b e a good opportunity for the Executive Committee member s to identify new topics for the future. He asked the members to give some thought to the issues that they would like the Board to address in the future

. There will be time on the agenda to discuss them at the October meeting. He then asked Mr. Susanke about the upcoming program reviews. Mr. Susanke re sponded that with the implementation of the ORD Transformation and implementation of Integrated Tra nsdisciplinary Research (ITR) there will be many changes in ORD that will affect the program reviews . That is a topic that will be discussed at the Oc tober meeting. He noted that the Land Research Program r eview was scheduled for January 2011, but given ORD’s shift to ITR, that review will be postponed. Dr. Ryan, who had agreed to chair that Subcommittee, said that he had spoken to Ms. Heathe r Drumm about the postponment. Dr. Chuck Haas asked if the Drinking Water Research Program Review was still on track. Mr. Susanke said that ORD is considering combining the Drinking Water and Water Quality Research Programs, so that review may be postponed.

Dr. Sayler asked if the members had received their travel reimbursement for the July meeting. Most members indicated that they had received their reim bursements. Dr. Sayler said that he had not receiv ed

his reimbursement. Mr. Susanke said he will look i nto the matter to get it resolved.



### Adjourn Dr. Gary Sayler, BOSC Executive Committee Chair

Dr. Sayler thanked the Executive Committee members for their participation and adjourned the call at 2:03 p.m.



### Action Items

 Dr. von Stackelberg will revise the letter report o n the Nanomaterial Case Studies Workshop Report and send it to Dr. Sayler by Friday, August 27. She will make the editorial corrections suggested by the Executive Committee, wordsmith the response to eliminate redundancies, and add a few sentences pertaining to the validity of the priority question s and the dynamic nature of that list.

 Dr. Sayler will confirm that the changes have been incorporated into the revised Nanomaterial Case Studies letter report, prepare the cover letter, an d submit them both to Mr. Susanke.E XECUTIVE C OMMITTEE A UGUST 25, 2010, C ONFERENCE C ALL S UMMARY

6  Mr. Susanke will send the BOSC responses to the SP2 Mid-Cycle Progress Report and the HHRA Mid-Cycle Progress Report as well as the letter rep ort on the Nanomaterial Workshop Report to the contractor for final formatting and editing.

 Executive Committee members will give some thought to the future issues that they would like the

BOSC to consider for discussion at the October meet ing.

 Dr. Sayler will work with Mr. Susanke to complete t he agenda for the October Executive Committee meeting.E XECUTIVE C OMMITTEE A UGUST 25, 2010, C ONFERENCE C ALL S UMMARY

7 

### P ARTICIPANTS 

### L IST

Executive Committee Members

Gary S. Sayler, Ph.D., Chair

Professor/Director Center for Environmental Biotechnology University of Tennessee

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

Kenneth L. Demerjian, Ph.D. (not present) Atmospheric Sciences Research Center State University of New York

Henry Falk, M.D., M.P.H. Director, Coordinating Center for Environmental Health and Injury Prevention

Centers for Disease Control and Prevention

Charles N. Haas, Ph.D.

L.D. Betz Professor of Environmental Engineering Department of Civil, Architectural, and Environmental Engineering Drexel University

Kenneth Olden, Ph.D., Sc.D., L.H.D. (not present)

School of Public Health City University of New York

Dennis Paustenbach, Ph.D., CIH, DABT 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 John Tharakan, Ph.D. College of Engineering, Architecture, and Computer Science, College of Medicine Howard University

Katherine von Stackelberg, Sc.D. Harvard Center for Risk Analysis

Harvard School of Public Health

Marie Zhuikov, M.A.

Private Communications Consultant

Designated Federal Officer

Greg Susanke U.S. Environmental Protection Agency Office of Research and Development

EPA ORD Participants

Patricia Gillespie

National Center for Environmental Assessment

Maureen Gwinn

National Center for Environmental Assessment

Tom Long

National Center for Environmental Assessment

Other Participants

Tera Fong Office of Management and Budget

Mike Hagan Office of Management and Budget

Doland Juberg Dow AgroSciences

Ann McCarthy Food and Drug Administration

Joe Velovitch Dow AgroSciences

Contractor Support

Beverly Campbell The Scientific Consulting Group, Inc.A Federal Advisory Committee for the U.S. Environme ntal Protection Agency’s Office of Research and Dev elopment 

### EXECUTIVE COMMITTEE MEETING

AGENDA Wednesday, August 25, 2010 1:00 p.m. – 3:00 p.m. Eastern Time

CONFERENCE CALL Participation by Teleconference Only

Wednesday, August 25, 2010

1:00 p.m. – 1:10 p.m. Welcome and Introductions Dr. Gary Sayler, - Overview of Agenda Chair, Executive Committee

1:10 p.m. – 1:15 p.m. BOSC DFO Remarks Mr. Greg Sus anke, Designated Federal Officer,

Office of Research and Development

1:15 p.m. – 1:45 p.m. BOSC Response to Safe Pestici des/ Dr. Barry Ryan Safe Products Mid-Cycle Progress Executive Commit tee Report

1:45 p.m. – 2:15 p.m. BOSC Response to Human Health Dr. Gary Sayler Risk Assessment Mid-Cycle Progress Chair, Executiv e Committee Report

2:15 p.m. – 2:45 p.m. BOSC Response to ORD Dr. Kath erine von Stackelberg, Nanomaterial Workshop Report Decision Analysis Wor kgroup Chair, Executive Committee 2:45 p.m. – 2:55 p.m. Public Comment

2:55 p.m. – 3:00 p.m. Future Business Dr. Gary Sayl er, Chair, Executive Committee

3:00 p.m. Adjourn