1 **Minutes of the United States Environmental Protection Agency (EPA)**  **Human Studies Review Board (HSRB) January 11, 2012**  **Public Teleconference Meeting Docket Number:**  **EP A**  **- HQ**  **- ORD**  **- 2011**  **- 0953**  **HSRB W**  **ebsite : http://www.epa.gov/osa/hsrb**  Committee Members: (See EPA HSRB Members list

– Attachment A) Date and Time: Wednesday , January 11, 2012 , 1 :00 p.m.

– 4 :00 p.m. (See Federal Register Notice

– Attachment B) Location: Via teleconference Purpose: The EPA Human Studies Review Board provides advice, information and

recommendations on issues related to the scientific and ethical aspects of human subjects research. Attendees: Chair: Sean Philpott, Ph.D., M.S. , Bioethics

Board Members: Janice Chambers, Ph.D., D.A.B.T.

George C.J. Fernandez, Ph.D. Jewell H. H alanych, M.D. Dallas E. Johnson, Ph.D. Michael D. Lebowitz, Ph.D., FCCP Jerry A. Menikoff, M.D. William J. Popendorf, Ph.D. Leonard Ritter, Ph.D. Virginia Ashby

Sharpe, Ph.D. Linda J. Young, Ph.D
. Meeting Summary : Meeting discussions generall y followed th e issues and general timing as

presented in the meeting Agenda (Attachment C), unless noted otherwise in these minutes. **CONVENE MEETING AND IDENTIFICATION OF BO**  **ARD MEMBERS** Mr. Jim Downing (Designated Federal Officer [DFO], Human Studies Review Board [ HS RB or Board] , Office of the Science Advisor [OSA], U.S. Environmental Protection Agency [EPA or Agency]) opened the teleconference meeting and welcomed Board members on behalf of the EPA Science Advisor Dr. Paul Anastas and the Program in Human Research Ethics. He noted that the Agency

appreciates the Board members’ time in preparing for the meeting . He also welcomed EPA colleagues and members of the public. The purpose of this teleconference meeting was to review the decisions made b y the Board at the Octo ber 19

- 20 , 2011 HSRB meeting and to finalize the Board report from that meeting. The October 2011 meeting was the first HSRB meeting to be webcast, and this is an important tool for providing greater2

transparency

and open government. The Agency would like feedback from those who attended the webcast; feedback may be submitted via email to Mr. Downing at downing.jim@epa.gov
. **MEETING ADMINISTRATI VE PROCEDURES**  As DFO, Mr. Downing serves as the liaison between the HSRB and EPA and ensures that Federal Adviso ry

Committee Act (FACA) requirements are met with regard to the operations of the HSRB . As DFO, he also works with the appropriate officials to ensure that all applicable ethics regulations are satisfied. Each Board member has been briefed on the provision s of the federal conflict of interest laws and has filed a standard government financial disclosure form that has been reviewed to ensure that all ethics disclosure requirements have been met. Mr. Downing reminded participants that meeting times listed on the agenda would be approximate, and that Board members should state their names before speaking. At the teleconference meeting, the Board will review the draft final report from the October 2011 meeting, and will finalize the report for submission to the Science Advisor and the Agency
. At the appropriate time, members of the public may provide public comments; these must be limited to 5 minutes. No individuals pre

- registered to provide public comments. Copies of the meeting materials are available on regulations.gov under the docket number EPA
- HQ
- ORD
- 2011
- 0 953 . According to FAC A requirements, meeting minutes including descriptions of the discussions and conclusions reached b y the Board will be prepared. These minutes will be certified by the Chair within 90 days of the meeting and posted at www.regulations.gov and on the HSRB website
. **MEETING PROCESS** Dr. Sean Philpott thanked the Board members for their diligent work at the October 2011 meeting and in completing their sections of the meeting report, and thanked the Agency staff for their help and comments. He explained that the Board would discuss the draft Board report, focusing on the charge questions presented to the Board and the HSRB ’s recommendations
. Dr. Philpott requested that the HSRB focus on s ubstantive changes to the report that directly affect the Board’s recommendations
. Board members should submit any ty pographical or grammatical corrections to Dr. Philpott and Mr. Downing via email. He requested that Board members identify the section of the report to which they were referring by

line number , and to identify themselves before speaking. The report is intended to be a summary of the HSRB’s consensus recommendations and not a detailed technical document. The Agency and study

sponsors have acce ss to detailed meeting minutes for additional information. He noted that a number of members of the public were participating in the teleconference , and that the meeting was being recorded for purposes of drafting the meeting minutes.3

**PUBLIC COMMENTS** Dr. Philpott invited public comment on the draft October 2011 HSRB meeting report. No public comments were presented. **BOARD DISCUSSION AND DECISION ON FINAL RE**  **PORT A**  **n e** **w s**  **ce n**  **a r**  **io d**  **e sign**  **a n**  **d asso**  **c ia**  **te d**  **p r**  **o t**  **o c**  **ol fr**  **o m**  **t h**  **e A**  **n t** **i m** **i c**  **r o**  **b ial**  **E x**  **p os**  **u re**  **Ass e**  **s s**  **m e**  **n t**  **T ask**  **F o**  **rc e**  **II (** **A E**  **A T**  **F -**  **I I**  **) ,**  **d e**  **s cr**  **i b**  **i n**  **g p**  **r o**  **p os**  **e d**  **re s**  **e a**  **rc h**  **t o**  **m o**  **n i**  **t or**  **t h**  **e d**  **e r**  **m al a**  **n d**  **i nh**  **ala t** **i o**  **n e**  **x p**  **os u**  **r e**  **of w**  **o r**  **k er**  **s w**  **h i** **le p**  **o u**  **r i**  **n g l**  **i qu**  **i d**  **a n**  **t i**  **m i**  **cr o**  **b ial**  **p e**  **s t** **i c**  **i de**  **p r**  **o du**  **ct s**  **f**

**r om**  **b o**  **t h**  **c o**  **n v**  **e n**  **t io**  **n al a**  **n d**  **re du**  **ce d**  **- s**  **p lash**  **c o**  **n t**  **ai n**  **er s.**  Dr. Philpott stated that the sci ence charge question was located at line 315 of the draft report, and asked whether the AEATF liquid pour study proposal, if revised as suggested in EPA ’s review and if the research is performed as described , would be likely to generate scientifically

reli able data useful for assessing the exposure of individuals who manually pour liquid antimicrobial products. The Board concluded that the protocol , as submitted for review and if modified in accordance with EPA and HSRB recommendations , is likely to generat e scientifically

reliable data useful for accessing exposure of individuals who manually pour liquid antimicrobial products. In addition to providing several other comments and suggestions, the Board also pointed out two limitations not identified within the protocol or by the Agency : the wider range of exposures that could occur when pouring products outdoors instead of indoors, and the unknown impact of potential differences in exposures between consumers and professionals. He asked if any Board members h ad questions or concerns about this recommendation and its rationale that begins on line 343. Dr. Linda Young noted a typographical error on line 364 that created redundancy . Dr. Philpott agreed to correct it . There were no other comments. Dr. Philpott stated the ethics charge question that begins on line 482 asked whether the AEATF liquid pour study proposal, if revised as suggested in EPA’s review and if the research is performed as described , would be likely to meet the a

ppli ca ble re qui re m ents of 40 C ode of Federal Regulations ( C F R) p art 26, subp arts K and L . The Board conclud ed that the protocol , as submitted for review and if modified in accordance with EPA and HSRB recommendations , is likely to meet the a

ppli cable re qui re m ents of 40 C F R p art 26, sub p arts K and L . He asked if any Board members had questions or concerns on the recommendation and its rationale that begins on line 498. There were no Board comments or questions. **A n**  **e w**  **s ce**  **n a**  **r io**  **d e**  **sign a**  **n d**  **asso c**  **ia te**  **d p**  **r o**  **t o**  **c ols**  **f r**  **om t**  **h e**  **Ag r**  **i c**  **u l**  **t u**  **r al**  **Ha nd**  **l e**  **r E**  **x p**  **o s**  **u re**  **T ask**  **F o**  **r c**  **e (** **AH ET**  **F) d**  **e s**  **cr i**  **b i**  **n g**  **p r**  **o p**  **os e**  **d re**  **s e**  **a rc**  **h t**  **o m**  **e as**  **ur e**  **d e**  **r m**  **al a**  **n d**  **i n**  **h ala**  **t ion**  **e x**  **p os**  **u r**  **e t**  **o w**  **o r**  **k er**  **s w**  **h o**  **u se**  **c los**  **e d**  **sys t**  **e m**  **e qu**  **i p**  **m e**  **n t**  **t o load**  **li qu**  **i d**  **p e**  **s t** **i c**  **i d**  **e p**  **r o**  **du ct**  **s f**  **r om**  **r et**  **u r**  **n a**  **b le**  **a n**  **d n**  **o n**  **- ret**  **u r**  **n a**  **b le**  **c o**  **n t**  **ai n**  **er s**  **.** Dr. Philpott noted that the discussion of the study begins on line 643
. The science charge question begins on line 692 and asked the Board whether the AHETF closed sy stem loading study proposal, if revised as suggested in the Agency ’s review and if research is performed as described, would be likely to generate scientifically reliable data , useful for assessing exposure4

of workers to closed s ys tems to load liquid pesticide products from returnable or non

- returnable containers. The Board concurred with the Agency’s assessment that the p roposed AHETF scenario and field study proposal, if revised as suggested and performed as described , is likel y to generate scientifically

reliable data , useful for assessing the exposure of workers using closed sy stems to load liquid pesticide products fro m returnable or non

- returnable containers. The Board raised a number of additional concerns for the Agency and study

sponsors to consider whe n collecting and analyzing the exposure data. Those detailed recommendations and suggestions begin on line 712. He asked if there were any Board questions or concerns about the recommendations and their rationale. Dr. Young pointed out that the sentence that begins on line 743 should read “Exposure and normalized exposure are interpretable onl y when the proportionality constant s are zero and one.” The word “respectivel y” should be deleted . Dr. Philpott agreed to make the change. No other members offered comments. Dr. Philpott noted that the ethics charge question was located at line 777, and asked the Board whether th e proposed AHETF scenario and field study proposal, if revised as suggested in EPA’s review and if the research is performed as described , is likel y to meet the applicable requirements of 40 CFR part 26, subparts K and L. The Board concluded that the proto col , as submitted for review and if modified in accordance with EPA and HSRB recommendations , is likely to meet applicable requirements of 40 CFR part 26, subparts K and L. The Board made a few additional recommendations that are detailed in lines 793 to 9 35. He asked if Board members had any questions or comments regarding the response to the Agency. No Board members offered comments. **A c**  **o m** **p l**  **ete d**  **C a**  **rr oll**  **- L**  **oye B**  **iologi c**  **al R e**  **s e**  **a rc**  **h , I**  **n c**  **. (**  **C LB**  **R) s**  **t ud**  **y (** **No M**  **as 003) t**  **o e** **val u**  **a t**  **e t**  **h e**  **f**

**i e**  **ld re**  **p e**  **ll e**  **n t**  **e ff** 

**i c**  **a c** **y aga i**  **n st**  **m o**  **s qu**  **i t**  **o e**  **s of a**  **p r**  **o d**  **u c**  **t c**  **o n**  **t ai**  **n i**  **n g 1**  **6 %**  **p a**  **r a**  **- met**  **h a**  **n e**  **- 3,8**  **- d**  **iol (PMD)**  **a n**  **d 2%**  **l e**  **m o**  **n g**  **r ass oil.**  Dr. Philpott mentioned that Dr. Sidney Green, who was unable to attend the teleconference meeting , had sent an email noting that on line 955, there was an erro r . The line reads “two untreated experienced volunteers from site 1 also participated as treated controls at site 2.” The sentence should conclude “as treated subjects at site 2,” and Dr. Philpott has made that change. Dr. Philpott stated that the Board’ s response to the science charge question begin s on line 997. The Agency

asked the Board whether the CLBR completed study No Mas 003 was sufficiently

sound from a scientific perspective to be used to estimate the duration of complete protection against mos quitoes provided by the tested repellant. The Board concurred with the Agency ’s assessment that the study provided scientifically

valid results to assess efficacy against mosquitoes for the formulation tested, and the detailed recommendations and rationale begin on line 1013. Dr. Philpott asked if any Board members had comments regarding the recommendations and rationale. No Board members offered comments. Dr. Philpott stated that the ethics charge question, which begins on line 1041, asked the Board whether the available information supported a determination that the study was conducted in substantial compliance with subparts K and L of 40 CFR part 26. The Board concurred with the Agency ’s assessment that the study submitted for review was conducted in su bstantial5

compliance with subparts K and L of 40 CFR part 26. The Board’s detailed recommendations and rationale are located on line s 1056 to 1137. He asked if any Board members had comments or concerns about the recommendations or rationale. No Board memb ers offered comments. **A pub**  **li s**  **h e**  **d re**  **p o**  **r t**  **b y**  **Moi e** **m e** **n e** **t al (**  **2011) of**  **an i**  **n te**  **n t** **io n**  **al e**  **x p**  **o s**  **u r**  **e hu**  **m an**  **s t**  **udy me**  **as u**  **r i**  **n g**  **d e**  **r m**  **al a b**  **so r** **p t** **ion of**  **silv e**  **r f**  **r om**  **t h**  **e u**  **se of**  **n a**  **n os**  **i lv**  **er -**  **c o**  **n t**  **ai n**  **i n**  **g w**  **o u**  **nd d re**  **ssi n**  **gs t**  **o tre**  **at m**  **a j**  **or bu**  **r n**  **s.** Dr. Philpott noted that the Agency proposed to use the data r eported in the study to make estimates of sy stemic absorption of silver as a nanoparticle through the skin. The Board’s consideration of the study begins on line 1140. He also noted that this is a “post

- rule” published study , so there are different considerations for the level of information that needs to be provided to the Board. EPA asked the Board to consider two science charge questions that begin on line 1180: Is the Moiemen et al study scientificall y sound, providing reliabl e data? If so, can the Moiemen et al study

be used to support the Agency ’s conclusion that the dermal absorption factor for silver from nanosilver on hum an skin is l e ss th an 0.1 percent? The Board concluded that despite several deficiencies identified in the study design, the small number of subjects and the interpretation of the data, it agreed overall with the Agency ’s assessment that the Moeimen et al study provided some potentially useful baseline information on dermal absorption of silver from nano silv er - containing wound dressing s . The Board also concluded that the Moiemen et al study could be used to support the Agency ’s conclusion that the dermal absorption for silver from nanosilver was less than 0.1 percent as part of an overall weight of evidence. The Board, however, recommended that the Agency clarify its assumptions in estimating the dermal absorption of silver from nanosilver, and that the Agency consider alternatives for estimating dermal absorption based on the study . The Board’s recommendation s and rationale begin on line 1210 and continue to line 1286. Dr. Philpott commented that Dr. William Popendorf also had submitted a statement to the Agency proposing some alternative approaches for estimating dermal absorption based on this study . Dr. Phi lpott asked if any Board members had questions or comments about the recommendations and rationale. No members offered comments. The ethics charge to the Board on the Moiemen et al study asked the Board to consider whether there was adequate information to support a determination that the study was conducted in substantial compliance with procedures at least as protective as those in subparts A through L o f 40 CFR part 26. The Board concurred with the Agency ’s assessment that there was sufficient information regarding the value of the research to society , subject selection, risks and benefits, independent ethics review, informed consent and respect for potential and enrolled subjects to conclude that the study was conducted in substantial compliance with procedures at least as protective as the relevant subparts of 40 CFR part 26. The Board’s detailed recommendations and rationale begin on line 1306 and continue to line 1380. He asked if any Board members had questions or comments on the recommendations an d rationale. No members offered comments.6

**SUMMARY AND NEXT STE PS**  Dr. Philpott commented that the lack of comments reflects well

- written discussions submitted for inclusion in the report, and the high

- quality of both the sponsors’ submissions and the Agency ’s review. He thanked both the Agency and the sponsors for their hard work. Dr. Michael Lebowitz stated that it was surprising , given the complicated nature of these studies , that the Board has conducted the review so well. As a longtime member of the B oard, he was very impressed b y the Board ’s review at the October 2011 meeting and the Agency ’s review. Dr. Philpott asked if the Agency representatives on the call had any questions, and they

did not. He asked that the Board move to the procedural vote to approve the final draft pending the modifications discussed during the teleconference
. Dr. Philpott called on each member in turn for a vote, and all members on the call who had attended the October 2011 meeting voted to approve the report unanimously . New members Drs. Jewell Halanych and Leonard Ritter abstained from voting because they had not been members at the time of the October 2011 deliberations. Mr. Downing thanked the members for a successful meeting and for their diligent work on the final repo rt . He noted that the next face

- to - face HSRB meeting would be held January 26, 2012 , at the EPA Conference Center at Potomac Yard South in Cry stal City , Virginia. He adjourned the meeting at 1:45 p.m.
Respectfully

submitted:

Jim Downing Designated Fe deral Officer Human Studies Review Board United States Environmental Protection Agency
Certified to be true b y:

Sean Philpott, Ph.D., M.S. , Bioethics Chair Human Studies Review Board United States Environmental Protection Agency7

NOTE AND DI SCLAIMER : The minutes of this public teleconference meeting reflect diverse ideas and suggestions offered b y Board members during the course of deliberations within the meeting. Such ideas, suggestions and deliberations do not necessaril y reflect definitive consen sus advice from the Board members. The reader is cautioned to not rely on the minutes to represent final, approved, consensus advice and recommendations offered to the Agency. Such advice and recommendations may

be found in the final report prepared and transmitted to the EPA Science Advisor following the public meeting.8 **Attachments**

Attachment A HSRB Members Attachment B Federal Register Notice Announcing Meeting Attachment C Meeting Agenda9 **Attachment A EPA HUMAN STUDIES REVIEW BOARD MEMBERS**  **Chair** *Sean Philpott, Ph.D., M.S. Bioethics Term: 3/27/2006

- 8/31/2012 Director, Research Ethics The Bioethics Program Union Graduate College

- Mt. Sinai School of Medicine Schenectady, NY **Vice Chair**
* ^ Rebecca T. Parkin, Ph.D., M.P.H Term: 10/1/2007

- 8/31/2 013 Professorial Lecturer (EOH) School of Public Health and Health Services The George Washington University Washington, DC **Members** *Janice Chambers, Ph.D., D.A.B.T. Term: 3/27/2006

- 8/31/2012 William L . Giles Distinguished Professor Director, Center for Environmental Health Sciences College of Veterinary

Medicine Mississippi State University Mississippi State, MS *George C.J. Fernandez, Ph.D. Term: 5/1/2010

- 8/31/2013 Statistical Training Specialist SAS Institute, Statistical Training and Technical Ser vices Sparks, NV
* ^Vanessa Northington Gamble, M.D., Ph.D. Term: 10/19/2009

- 10/31/2012 University

Professor of Medical Humanities Gelman Library The George Washington University Washington, DC
* ^ Sidney Green, Jr., Ph.D., Fellow ATS Term: 10/19/2009

- 10/31 /2012 Department of Pharmacology Howard University

College of Medicine Howard University Washington, DC10

*Jewell H. Halanych, M.D. Term: 11/14/2011

- 8/31/2014 Assistant Professor Department of Medicine Division of Preventative Medicine University

of Alabama at Birmingham Birmingham, AL *Dallas E. Johnson, Ph.D. Term: 8/31/2007

- 8/31/2013 Professor Emeritus Department of Statistics Kansas State University Manhattan, KS *Michael D. Lebowitz, Ph.D., FCCP Term: 3/27/2006

- 8/31/2012 Retired Professor of Public H ealth (Epidemiology) & Medicine & Research Professor of Medicine University

of Arizona Tucson, AZ
* ^ José E. Manautou, Ph.D. Term: 5/1/2010

- 8/31/2013 Associate Professor of Toxicology Department of Pharmaceutical Sciences School of Pharmacy , University of Connecticut Storrs, CT Jerry A. Menikoff, M.D. Term: 3/27/2006

- 8/31/2012 Director, Office for Human Research Protections Department of Health and Human Services Rockville, MD *William J. Popendorf, Ph.D. Term: 10/19/2009

- 10/31/2012 Professor Emeritus Department of Biology Utah State University Lo gan, UT *L eonard Ritter, Ph.D. Term: 11/14/2011

- 8/31/2014 Professor Emeritus (Toxicology) School of Environmental Sciences University

of Guelph Guelph, Ontario, Canada11

* ^Bernard A. Schwetz, D.V.M. , Ph.D. Ter m: 11/14/2011

- 8 /31/201 4 Retired Director Office of Human Research Protections Department of Health and Human Services Cadott, WI Virginia Ashby

Sharpe, Ph.D. Term: 5/1/2010

- 8/31/2013 National Center for Ethics in Health Care Veterans Health Administratio n Department of Veterans Affairs Washington, DC *Linda J. Young, Ph.D. Term: 3/28/2008

- 8/31/2012 Department of Statistics Institute of Food and Agricultural Sciences University

of Florida Gainesville, FL *Special Government Employee (SGE) ^Not in atten dance at the January 11, 2012 teleconference meeting12 **Attachment B FEDERAL REGISTER NOTICE ANNOUNCING MEETING**  [Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)] [Notices] [Pages 77825
- 77827] From the Federal Register Online via the G overnment Printing Office [ www.gpo.gov ] [FR Doc No: 2011
- 32060]

----------------------------------------------------------------------- **ENVIRONMENTAL PROTECTION AGENCY [EPA** **- HQ**  **- ORD**  **- 2011**  **- 0953; FRL**  **- 9506**  **- 6]**  **Human Studies R eview Board; Notification of a Public Teleconference**  **AGENCY:** Environmental Protection Agency. **ACTION:** Notice.

----------------------------------------------------------------------- **SUMMARY:** The EPA Office of the Science Advisor announces a public telec onference of the HSRB to discuss its draft report from the October 19

- 20, 2011 HSRB meeting. **DATES:** The teleconference will be held on Wednesday, January 11, 2012 from approximately 1 p.m. to approximately 4 p.m. Eastern Time. Comments may be submitted on or before Wednesday, January 4, 2012. **ADDRESSES:** Submit your written comments, identified by Docket ID No. EPA

- HQ
- ORD
- 2011
- 0953, by one of the following methods: Internet : http://www.regulations.gov : Follow the Web site instructions for submitting comments. Email : ORD.Docket@epa.gov
. Mail : Environmental Protection Agency, EPA Docket Center EPA/DC, ORD Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460. Hand Delivery : The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA West Building, located at 1301 Constitution Avenue NW., Washington, DC 20460. The hours of operation are 8:30 a .m. to 4:30 p.m. [[Page 77826]] Eastern Time, Monday through Friday, excluding Federal holidays. Please call (202) 566

- 1744 or email the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available online at http://www.epa.gov/epahome/dockets.htm
. Instructions : Direct your comments to Docket ID No. EPA

- HQ
- ORD
- 2011
- 0953. The Agency's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov , including any personal information provided, unless the comments includes information claimed to be Confidential Business Information or other information the disclosure of which is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site is an “ anonymous access ” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through http://www.regulations.gov , your email address will be automatically13

captured and included as part of the comment that is placed in the public docket and made available on the Inte rnet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comments and with any disk or CD

- ROM you submit. If the EPA cannot read your co mment due to technical difficulties an d cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. **FOR FURTHER INFORMATION CONTACT:** Any memb ers of the public who wish to receive further information should contact Jim Downing on telephone number (202) 564

- 2468; fax (202) 564

- 2070; email address downing.jim@epa.gov or Lu
- Ann Kleibacker on telephone numb er (202) 564

- 7189; fax: (202) 564

- 2070; email address kleibacker.lu

- ann@epa.gov ; mailing address Environmental Protection Agency, Office of the Science Advisor, Mail Code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 20460. General information concerning the EPA HSRB can be found on the EPA Web site at http://www.epa.gov/osa/hsrb
. **SUPPLEMENTARY INFORMATION:** Location : The meeting will take place via tel ephone only. Meeting access : For information on access or services for individuals with disabilities, please contact Lu
- Ann Kleibacker at least ten business days prior to the meeting using the information under **FOR FURTHER INFORMATION CONTACT**  , so that appropriate arrangements can be made. Procedures for providing public input : Interested members of the public may submit relevant written or oral comments for the HSRB to consider during the advisory process. Additional information concerning submiss ion of relevant written or oral comments is provided in section I, “ Public Meeting, ” under subsection D, “ How May I Participate in this Meeting? ” of this notice. **I. Public Meeting** A. Does this action apply to me? This action is directed to the publ ic in general. This action may, however, be of particular interest to persons who conduct or assess human studies, especially studies on substances regulated by the EPA, or to persons who are, or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act or the Federal Insecticide, Fungicide, and Rodenticide Act. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult Jim Downing or Lu

- Ann Kleibacker listed under **FOR FURTHER INFORMATION CONTACT.**  B. How can I access electronic copies of this document and other related info rmation? You may use http://www.regulations.gov , or you may access this **Federal Register** document via the EPA's Internet site under the “ **Federal Register** ” listings at http://www.epa.gov/fedrgstr
. Docket : All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or o ther information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically at http://www.regulations.gov or in hard copy at the ORD Docket, EPA/DC Public Reading Room. The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA West Building, located at 1301 Constituti on Avenue NW , Washington, DC 20460; its hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, excluding Federal holidays.14

Please call (202) 566

- 1744, or email the ORD Docket at ord.docket@epa.gov for instructions. Updates regar ding the Public Reading Room access are available at http://www.epa.gov/epahome/dockets.htm
. C. What should I consider as I prepare my comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data used that support your views. 4. Provide specific exam

ples to illustrate your concerns and suggest alternatives. 5. To ensure proper receipt by the EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date and **Federal Register** citation. D. How may I participate in this meeting? You may participate in this meeting by following the instructions in this section. To ensure proper receipt by the EPA, it is imperative that you identify Docket ID No. EPA

- HQ
- ORD
- 2011
- 0953 in the subject line on the first page of your request. 1. Oral comments . Requests to present oral comments will be accepted up to and including Wednesday, January 4, 2012. To the extent that time permits, interested persons who have not pre registered may be permitted by the Chair of the HSRB to present oral comments during the meeting. Each individual or group wishing to make brief oral comments to the HSRB is strongly advised to submit their request (preferably via email) to Jim Downing or Lu

- Ann Kleibacker under **FOR FURTHER**  **INFORMATION CONTACT** no later than noon, Eastern Time, Wednesday, January 4, 2012, in order to be included on the meeting agenda and to provide sufficient time for the HSRB Chair and HSRB Designated Federal Offici al to review the meeting agenda to provide an [[Page 77827]] appropriate public comment period. The request should identify the name of the individual making the presentation and the organization (if any) the individual will represent. Oral comments before the HSRB are generally limited to five minutes per individual or organization. Please note that this includes all individuals appearing either as part of, or on behalf of, an organization. While it is our intent to hear a full range of oral comments on th e science and ethics issues under discussion, it is not our intent to permit organizations to expand the time limitations by having numerous individuals sign up separately to speak on their behalf. If additional time is available, further public comments may be possible. 2. Written comments . Please submit written comments prior to the meeting. For the HSRB to have the best opportunity to review and consider your comments as it deliberates on its report, you should submit your comments at least five bus iness days prior to the beginning of this teleconference. If you submit comments after this date, those comments will be provided to the Board members, but you should recognize that the Board members may not have adequate time to consider those comments prior to making a decision. Thus, if you plan to submit written comments, the Agency strongly encourages you to submit such comments no later than noon, Eastern Time, Wednesday, January 4, 2012. You should submit your comments using the instructions in secti on I, under subsection C, “ What Should I Consider as I Prepare My Comments for EPA? ” In addition, the Agency also requests that persons submitting comments directly to the docket also provide a copy of their comments to Jim Downing or Lu

- Ann Kleibacker lis ted under **FOR FURTHER INFORMATION CONTACT** . There is no limit on the length of written comments for consideration by the HSRB.15

E. Background The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory Committee Act 5 U.S .C. App.2 section 9. The HSRB provides advice, information, and recommendations to EPA on issues related to scientific and ethical aspects of human subjects research. The major objectives of the HSRB are to provide advice and recommendations on: (1) Research proposals and protocols; (2) reports of completed research with human subjects; and (3) how to strengthen EPA's programs for protection of human subjects of research. The HSRB reports to the EPA Administrator through the EPA Science Advisor. 1. Top ics for Discussion . The HSRB will be reviewing its draft report from the October 19

- 20, 2011, HSRB meeting. The Board may also discuss planning for future HSRB meetings. Background on the October 19

- 20, 2011 HSRB meeting can be found at the HSRB Web site: http://www.epa.gov/osa/hsrb
. The October 19

- 20, 2011 meeting draft report is now available. You may obtain electronic copies of this document, and certain other related documents that might be available electroni cally, from regulations.gov Web site and the HSRB Web site at http://www.epa.gov/osa/hsrb . For questions on document availability or if you do not have Internet access, consult the persons listed under **FOR FURTHER INFORMATION CONTACT** 
. 2. Meeting minutes and reports . Minutes of the meeting, summarizing the matters discussed and recommendations, if any, made by the advisory committee regarding such matt ers, will be released within 90 calendar days of the meeting. Such minutes will be available at http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov . In addition , information regarding the Board's final meeting report will be found at http://www.epa.gov/osa/hsrb or from the persons listed under **FOR FURTHER INFORMATION CONTACT.**  Dated: December 7, 2011. **Paul T. Anast as,**  EPA Science Advisor
. [FR Doc. 2011
- 32060 Filed 12

- 13
- 11; 8:45 am] **BILLING CODE 6560 -**  **50 -**  **P**16 **Attachment C UNI**  **TE D**  **ST A**  **TE S**  **E NVIRON**  **M E**  **N T**  **AL PRO**  **TE C**  **T ION A**  **G E**  **NCY**

**HU M** **AN ST**  **UDI E**  **S R** **E VI**  **E W**  **B OARD**  **( H**  **S R** **B )**  **P U**  **BL IC**  **TELE CON**  **F E**  **R E**  **NCE M**  **EET ING A**  **G E**  **NDA**

**W e**  **dn e**  **s d**  **ay, Ja nu**  **a r** **y 1**  **1, 2012 1**  **: 00**  **p m**  **- 4**  **: 00**  **p m**  **( E**  **a s**  **ter n**  **T i**  **me)** ***** **H S**  **RB M**  **EET ING**  **F OR**  **R E**  **VI E**  **W AND A**  **P P** **R OVAL**  **OF T**  **HE DR A**  **F T**  **OC T**  **O BE**  **R 19 -**  **20, 2011 H**  **S RB**  **M EE**  **T ING**  **R E**  **P ORT**  **H S**  **RB W**  **ebsite: h**  **tt p**  **: //ww** **w .**  **e p**  **a.gov/osa /** **h s**  **rb /**  **Do c**  **k e**  **t T**  **e l**  **e ph**  **o n**  **e :**  **( 20**  **2 )**  **566 -**  **1752 Do**  **c k**  **e t**  **N u**  **m b**  **e r**  **: E**  **P A** 

**– HQ** 

**– ORD** 

**– 2011** 

**– 0953** 
**1 :**  **00 PM Co**  **n v**  **e n**  **e Me**  **e t** **i n**  **g a n**  **d I**  **d e**  **n t** **i f**  **i c**  **a t** **ion o**  **f B**  **oa r**  **d M**  **e m** **b er**  **s**
– J im Downing ( D e s i gn at e d Fe d eral O ff

i cer , H SRB , O S A , EPA ) **1 :**  **10 P M**  ***** **Meet i**  **n g A**  **d m** **i n**  **is tr**  **a t** **ive P**  **r o**  **ce du**  **re s** 
– J im Downin g (D F O ) **1 :**  **15 PM Meet** **i n**  **g P**  **r o**  **ce ss**  **–** S e an P h ilp o tt , P h.D. ( H SRB C h ai r) **1 :**  **20 PM P**  **ub lic**  **C o**  **mme n**  **t s**  **1 :**  **30 PM B**  **oa r**  **d Dis**  **c u**  **ssion a**  **n d**  **D ec**  **ision on**  **F i**  **n al R** **e p**  **o r** **t**

**–** S ean P hilpott, P h.D. ( H SRB

C h ai r) The B o ard ’ s r e sponse to E P A c h ar g e qu e stions p r e s e nt e d at the O c tob e r 1 9
- 20, 2011 m ee tin g . **A n**  **e w**  **s ce**  **n a**  **r io**  **d e**  **sign a**  **n d**  **asso c**  **ia te**  **d p**  **r o**  **t o**  **c ol**  **fr o**  **m t**  **h e**  **A n**  **t i**  **m i**  **c r**  **o b**  **ial E**  **x p**  **os u**  **re Ass**  **e s**  **s m**  **e n**  **t T**  **ask F**  **o rc**  **e II**  **( A** **E A**  **T F**  **- I**  **I )**  **, d**  **e s**  **cr i**  **b i**  **n g**  **p r**  **o p**  **os e**  **d re**  **s e**  **a rc**  **h t**  **o m**  **o n**  **i t**  **or t**  **h e**  **d e**  **r m**  **al a n**  **d i**  **nh ala**  **t i**  **o n**  **e x**  **p os**  **u r**  **e of**  **w o**  **r k**  **er s**  **w h**  **i le**  **p o**  **u r**  **i n**  **g l i**  **qu i**  **d a**  **n t** **i m** **i cr**  **o b**  **ial p**  **e s**  **t i**  **c i**  **de p**  **r o**  **du ct**  **s f** 

**r om**  **b o**  **t h**  **c o**  **n v**  **e n**  **t io**  **n al a**  **n d**  **re du**  **ce d**  **- s**  **p lash**  **c o**  **n t**  **ai n**  **er s.**  C h arge to the B o ard: I f the AEA T F liquid pour stu dy p ropo s al is re vis e d a s sugg e st e d in E P A ’ s re vi ew and i f the re s e arc h is p er f

o r m e d a s d e s crib e d:

 I s the re s e arc h lik e l y to g en erat e s c i enti f i c al l y r e li a

ble d at a , us e f

ul f or a ss e s sing the e xposure of individu als who m anu al l y po ur liquid antimi crobi al p rodu c ts?  I s the re s e arc h lik e l y to m ee t the a ppli ca ble re qui re m ents of 40 C F R p art 26, subp arts K and L?17

**A n**  **e w**  **s ce**  **n a**  **r io**  **d e**  **sign a**  **n d**  **asso c**  **ia te**  **d p**  **r o**  **t o**  **c ols**  **f r**  **om t**  **h e**  **Ag r**  **i c**  **u l**  **t u**  **r al**  **Ha nd**  **l e**  **r E**  **x p**  **o s**  **u re**  **T ask**  **F o**  **r c**  **e (** **AH ET**  **F) d**  **e s**  **cr i**  **b i**  **n g**  **p r**  **o p**  **os e**  **d re**  **s e**  **a rc**  **h t**  **o m**  **e as**  **ur e**  **d e**  **r m**  **al a**  **n d**  **i n**  **h ala**  **t ion**  **e x**  **p os**  **u r**  **e t**  **o w**  **o r**  **k er**  **s w**  **h o**  **u se**  **c los**  **e d**  **sys t**  **e m**  **e qu**  **i p**  **m e**  **n t**  **t o load**  **li qu**  **i d**  **p e**  **s t** **i c**  **i d**  **e p**  **r o**  **du ct**  **s f**  **r om**  **r et**  **u r**  **n a**  **b le**  **a n**  **d n**  **o n**  **- ret**  **u r**  **n a**  **b le**  **c o**  **n t**  **ai n**  **er s**  **.** C h arge to the B o ard: I f the AHE T F c lo s e d s ys t e m liquid lo a ding stu dy p ropos al is re vis e d a s su gg e st e d in E P A ’ s re vi e w and i f the re s ear c h is p erf o r m e d a s d e s c rib e d:

 I s the re s e arc h lik e l y to g en erat e s c i enti f i c al l y r e li a

ble d at a , us e f

ul f or a ss e ssing the e xposure of wo r

k er s using c los e d s ys t e ms to lo a d liquid p e sti c ide produ c ts from re tur n a ble o r non - r e tur

n a ble c ont ain er s?  I s the re s e arc h lik e l y to m ee t the a ppli ca ble re qui re m ents of 40 C F R p art 26, subp arts K and L? **A c**  **o m** **p l**  **ete d**  **C a**  **rr oll**  **- L**  **oye B**  **iologi c**  **al R e**  **s e**  **a rc**  **h , I**  **n c**  **. (**  **C LB**  **R) s**  **t ud**  **y (** **No M**  **as 003) t**  **o e** **val u**  **a t**  **e t**  **h e**  **f**

**i e**  **ld re**  **p e**  **ll e**  **n t**  **e ff** 

**i c**  **a c** **y agai n**  **st m**  **o s**  **qu i**  **t o**  **e s of**  **a p**  **r o**  **d u**  **c t**  **c o**  **n t**  **ai n**  **i n**  **g 1 6**  **% p**  **a r**  **a**   ** met** **h a**  **n e**  **- 3,8**  **- d**  **iol a n**  **d 2%**  **l e**  **m o**  **n g**  **r ass oil.**  C h arge to the B o ard:

 I s the C LB R c ompl e t e d s tu dy No M a s 003 su f f i c i e nt l y sound, from a s c i e nti f ic p er sp ec tiv e , t o b e us e d to e stim ate the du ration of c ompl e te p rot ec tion ag ai nst mosquito e s p rovid e d b y the t e st e d r e p e ll ent?  Do e s av ail a

ble i n f o r m a ti on suppo rt a d e t er

min ati on th at the stu dy No M a s 003 w a s c ondu c t e d in subst anti al c ompli an c e with 40 C F R p art 26, subp art s K and L? **A pub**  **li s**  **h e**  **d re**  **p o**  **r t**  **b y**  **Moi e** **m e** **n e** **t al (**  **2011) of**  **an i**  **n te**  **n t** **io n**  **al e**  **x p**  **o s**  **u r**  **e hu**  **m an**  **s t**  **udy me**  **as u**  **r i**  **n g**  **d e**  **r m**  **al a b**  **so r** **p t** **ion of**  **silv e**  **r f**  **r om**  **t h**  **e u**  **se of**  **n a**  **n os**  **i lv**  **er -**  **c o**  **n t**  **ai n**  **i n**  **g w**  **o u**  **nd d**  **re ssi**  **n gs**  **t o**  **tre at**  **m a** 

**j or**  **bu r**  **n s.**  C h arge to the B o ard:

 I s the Mo i e m e n ( 2011) s tu dy s c i enti f i cal l y sound, p roviding r e li a ble d at a ?  I f so, can the Mo i e m en ( 2011) stu dy be u s e d to suppo rt the A g en c y's c on c l usion th at the d er m al a bso r pti o n fac tor f

o r silv er f rom n anosilv er on hum an skin is l e ss th an 0.1 % ?  I s th ere a d e qu ate i n f

o r m ation to suppo rt a d e t er

min ation th at the study w a s c ondu c t e d in subst anti al c ompli an c e p ro ce dur e s at l ea st a s p rot ec tive a s th o se at subp arts A
- L of 40 C F R p art 2 6 ? **3 :**  **55 PM Su**  **m m**  **a r** **y a n**  **d N**  **e xt**  **S t**  **ep s**  **–** S ean P hilpott, P h.D. ( H SRB C h ai r) and J im

Downing ( D F O) **4 :**  **00 PM A**  **d**

**j o**  **u r**  **n m**  **e nt**