Document ID: EPA_FRDOC_0001-14575
Agency: epa
Document Type: Notice
Title: Requests for Nominations: Experts to Review the Draft Toxicological Assessments for Ammonia, Trimethylbenzenes, etc.
Posted Date: 2013-08-28T04:00Z

[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Notices]
[Pages 53144-53146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20911]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9900-45-OA]

Request for Nominations of Experts To Augment the Science 
Advisory Board Chemical Assessment Advisory Committee for the Review of 
the EPA's Draft Toxicological Assessments for Ammonia, 
Trimethylbenzenes and the Evaluation of Inhalation Carcinogenicity of 
Ethylene Oxide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The EPA Science Advisory Board (SAB) Staff Office requests 
public nominations of scientific experts to augment the SAB Chemical 
Assessment Advisory Committee (CAAC) to form three panels for the 
review of: (1) The EPA's draft Toxicological Review of Ammonia; (2) the 
EPA's draft Toxicological Review of Trimethylbenzenes; and (3) the 
EPA's draft Evaluation of the Inhalation Carcinogenicity of Ethylene 
Oxide In Support of Summary Information on the Integrated Risk 
Information System (IRIS).

DATES: Nominations should be submitted by September 18, 2013 per the 
instructions below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing 
further information regarding this Notice and Request for Nominations 
may contact the appropriate Designated Federal Officer for the specific 
review, as identified below. Nominators unable to submit nominations 
electronically as described below may contact the Designated Federal 
Officers for assistance. General information concerning the EPA SAB can 
be found at the EPA SAB Web site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION: 
    Background: The SAB (42 U.S.C. 4365) is a chartered Federal 
Advisory Committee that provides independent scientific and technical 
peer review, advice, consultation, and recommendations to the EPA 
Administrator on the technical basis for EPA actions. As a Federal 
Advisory Committee, the SAB conducts business in accordance with the 
Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and related 
regulations. The SAB Chemical Assessment Advisory Committee (CAAC) is a 
subcommittee of the SAB that provides advice through the chartered SAB 
regarding assessments of environmental chemicals available on EPA's 
Integrated Risk Information System (IRIS). The SAB and the CAAC, 
augmented with additional experts, will comply with the provisions of 
FACA and all appropriate SAB Staff Office procedural policies.
    The National Center for Environmental Assessment (NCEA) in the 
EPA's Office of Research and Development (ORD) develops toxicological 
reviews/assessments for various chemicals for EPA's Integrated Risk 
Information System (IRIS). NCEA has developed two separate draft IRIS 
assessments for ammonia and trimethylbenzenes, and a draft evaluation 
of the inhalation carcinogenicity for ethylene oxide for IRIS. NCEA has 
asked the SAB to peer review draft documents for ammonia, 
trimethylbenzenes, and ethylene oxide. The SAB Staff Office is seeking 
experts to augment the SAB CAAC to form three separate panels to 
conduct the peer reviews.
    (1) NCEA's draft Toxicological Review of Ammonia (August 2013) 
represents a reassessment of the toxicity of ammonia. The assessment 
and proposed charge questions may be found at the following URL: http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/IRIS%20Ammonia?OpenDocument. The ammonia assessment currently posted to 
the IRIS database includes an inhalation reference concentration (RfC, 
posted in 1991). For the 2013 draft review, NCEA evaluated 
epidemiological data, experimental animal data, and other relevant data 
from studies of the noncancer and cancer effects of ammonia. This 
reassessment includes an inhalation RfC and a qualitative cancer 
descriptor. The assessment does not include an oral reference dose 
(RfD) or a quantitative cancer assessment because NCEA considered that 
adequate information was not available.
    (2) NCEA's draft Toxicological Review of Trimethylbenzenes (August 
2013) is the first IRIS assessment developed for trimethylbenzenes 
(TMBs), including 1,2,3-TMB; 1,2,4-TMB; 1,3,5-TMB. The assessment and 
proposed charge questions may be found at the following URL: http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/IRIS%20Trimethylbenzenes?OpenDocument. NCEA has evaluated experimental 
animal data and other relevant noncancer data in this assessment. The 
assessment includes an inhalation RfC, oral RfD, and qualitative cancer 
descriptor for each isomer. The assessment does not include a 
quantitative cancer assessment.
    (3) NCEA has developed a draft Evaluation of the Inhalation 
Carcinogenicity of Ethylene Oxide (July 2013 Draft). The draft 
evaluation and

[[Page 53145]]

proposed charge questions may be found at the following URL: http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/Eto%20Inhalation%20Carcinogenicity?OpenDocument. This draft evaluation 
has been revised based on recommendations provided by the SAB in 2007 
resulting from their peer review of an earlier version of the 
carcinogenicity assessment. The SAB report, Review of Office of 
Research and Development (ORD) draft assessment entitled, ``Evaluation 
of the Carcinogenicity of Ethylene Oxide'' (EPA-SAB-08-004), is 
available at: http://yosemite.epa.gov/sab/sabproduct.nsf/
02ad90b136fc21ef85256eba00436459/5D661BC118B527A3852573B80068C97B/
$File/EPA-SAB-08-004-unsigned.pdf.
    Technical Contact for EPA's draft assessments: For information 
concerning the EPA draft assessments, please contact Dr. Samantha 
Jones, National Center for Environmental Assessment, Office of Research 
and Development, U.S. EPA, 1200 Pennsylvania Avenue NW., Mail Code 
8601P, Washington, DC 20460, phone (703) 347-8580 or via email at 
jones.samantha@epa.gov.
    Request For Nominations: The SAB Staff Office is seeking 
nominations of nationally and internationally recognized scientists 
with demonstrated expertise and research to augment the CAAC for three 
separate review panels.
    (1) For the peer review of the EPA's draft Toxicological Review of 
Ammonia, the SAB Staff Office seeks experts in one or more of the 
following areas, with a particular focus on ammonia: toxicology of 
ammonia (and ammonium compounds); epidemiology with experience in 
respiratory effects (i.e., irritants and measures of lung function); 
toxicokinetics and the role of endogenous ammonia in maintaining 
nitrogen homeostasis; and inhalation toxicology. Questions regarding 
this review should be directed to Dr. Sue Shallal, Designated Federal 
Officer (DFO), SAB Staff Office, by telephone/voice mail at (202) 564-
2057, by fax at (202) 565-2098, or via email at shallal.suhair@epa.gov.
    (2) For the peer review of the EPA's draft Toxicological Review of 
Trimethylbenzenes, the SAB seeks experts in one or more of the 
following areas, particularly with respect to trimethylbenzenes: 
Developmental neurotoxicity, developmental toxicity, pharmacokinetic 
modeling, respiratory and inhalation toxicology, hematological 
toxicology, and carcinogenicity. Questions regarding this review should 
be directed to Mr. Thomas Carpenter, Designated Federal Officer (DFO), 
SAB Staff Office, by telephone/voice mail at (202) 564-4885, by fax at 
(202) 565-2098, or via email at carpenter.thomas@epa.gov.
    (3) For the peer review of the EPA's draft Evaluation of the 
Inhalation Carcinogenicity of Ethylene Oxide, the SAB Staff Office is 
seeking expertise in epidemiology, biostatistics, exposure-response 
modeling, genotoxicity, cancer biology, and risk assessment. Questions 
regarding this review may be directed to Mr. Aaron Yeow, Designated 
Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at 
(202) 564-2050, by fax at (202) 565-2098, or via email at 
yeow.aaron@epa.gov.
    Process and Deadline for Submitting Nominations: Any interested 
person or organization may nominate qualified individuals in the areas 
of expertise described above for possible service on any of the 
augmented CAAC panels identified in this notice.
    Nominations should be submitted in electronic format (preferred 
over hard copy) following the instructions for ``Nominating Experts to 
Advisory Panels and Ad Hoc Committees Being Formed,'' http://www.epa.gov/sab provided on the SAB Web site (see the ``Nomination of 
Experts'' link on the blue navigational bar at http://www.epa.gov/sab). 
To receive full consideration, nominations should include all of the 
information requested below.
    EPA's SAB Staff Office requests contact information about the 
person making the nomination; contact information about the nominee; 
the disciplinary and specific areas of expertise of the nominee; the 
nominee's resume or curriculum vitae; sources of recent grant and/or 
contract support; and a biographical sketch of the nominee indicating 
current position, educational background, research activities, and 
recent service on other national advisory committees or national 
professional organizations.
    Persons having questions about the nomination procedures, or who 
are unable to submit nominations through the SAB Web site, should 
contact Dr. Sue Shallal, Mr. Thomas Carpenter, or Mr. Aaron Yeow, as 
indicated above in this notice. Nominations should be submitted in time 
to arrive no later than September 18, 2013. EPA values and welcomes 
diversity. In an effort to obtain nominations of diverse candidates, 
EPA encourages nominations of women and men of all racial and ethnic 
groups.
    The EPA SAB Staff Office will acknowledge receipt of nominations. 
The names and biosketches of qualified nominees identified by 
respondents to this Federal Register notice, and additional experts 
identified by the SAB Staff, will be posted in a List of Candidates for 
each of the three panels on the SAB Web site at http://www.epa.gov/sab. 
Public comments on each List of Candidates will be accepted for 21 
days. The public will be requested to provide relevant information or 
other documentation on nominees that the SAB Staff Office should 
consider in evaluating candidates.
    For the EPA SAB Staff Office a balanced review panel includes 
candidates who possess the necessary domains of knowledge, the relevant 
scientific perspectives (which, among other factors, can be influenced 
by work history and affiliation), and the collective breadth of 
experience to adequately address the charge. In forming these expert 
panels, the SAB Staff Office will consider public comments on the Lists 
of Candidates, information provided by the candidates themselves, and 
background information independently gathered by the SAB Staff Office. 
Selection criteria to be used for panel membership include: (a) 
Scientific and/or technical expertise, knowledge, and experience 
(primary factors); (b) availability and willingness to serve; (c) 
absence of financial conflicts of interest; (d) absence of an 
appearance of a loss of impartiality; (e) skills working in committees, 
subcommittees and advisory panels; and, (f) for the panel as a whole, 
diversity of expertise and scientific points of view.
    The SAB Staff Office's evaluation of an absence of financial 
conflicts of interest will include a review of the ``Confidential 
Financial Disclosure Form for Special Government Employees Serving on 
Federal Advisory Committees at the U.S. Environmental Protection 
Agency'' (EPA Form 3110-48). This confidential form allows government 
officials to determine whether there is a statutory conflict between a 
person's public responsibilities (which include membership on an EPA 
federal advisory committee) and private interests and activities, or 
the appearance of a lack of impartiality, as defined by federal 
regulation. The form may be viewed and downloaded from the following 
URL address http://yosemite.epa.gov/sab/sabproduct.nsf/Web/ethics?OpenDocument.
    The approved policy under which the EPA SAB Office selects members 
for subcommittees and review panels is described in the following 
document: Overview of the Panel Formation

[[Page 53146]]

Process at the Environmental Protection Agency Science Advisory Board 
(EPA-SAB-EC-02-010), which is posted on the SAB Web site at http://www.epa.gov/sab/pdf/ec02010.pdf.

    Dated: August 19, 2013.
Christopher Zarba,
Acting Director, Science Advisory Board Staff Office.
[FR Doc. 2013-20911 Filed 8-27-13; 8:45 am]
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