UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

 WASHINGTON D.C. 20460 

March 26, 2007 

OFFICE OF THE ADMINISTRATOR 

SCIENCE ADVISORY BOARD 

Memorandum

SUBJECT: Formation of Clean Air Scientific Advisory Committee (CASAC) 

NOX and SOX Primary Review Panel 

FROM: Fred Butterfield /Signed/

 Designated Federal Officer (DFO) 

Clean Air Scientific Advisory Committee 

 EPA Science Advisory Board Staff Office (1400F) 

TO: Vanessa Vu, Ph.D. 

Staff Director 

EPA Science Advisory Board (1400F) 

VIA: Daniel Fort /Signed/

Ethics & FACA Policy Officer 

 EPA Science Advisory Board Staff Office (1400F) 

The Clean Air Scientific Advisory Committee (CASAC), which is comprised of seven 

members appointed by the EPA Administrator, was established under section 109(d)(2) of the 

Clean Air Act (CAA or Act) (42 U.S.C. 7409) as an independent scientific advisory committee. 

The CASAC provides advice, information and recommendations on the scientific and technical 

aspects of air quality criteria and National Ambient Air Quality Standards (NAAQS) under 

sections 108 and 109 of the Act. The CASAC is a Federal advisory committee chartered under 

the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App. Section 109(d)(1) of 

the CAA requires that the Agency carry out a periodic review and revision, where appropriate, of 

the air quality criteria and the NAAQS for “criteria” air pollutants including oxides of nitrogen 

(NOX) and sulfur oxides (SOX).

On August 7, 2006 the SAB Staff Office announced in the Federal Register (71 FR 

44695) the formation of the CASAC NOX and SOX Primary Review Panel and solicited 

nominations for experts to supplement the statutory CASAC. This memorandum addresses the 

set of determinations that were necessary for forming the CASAC NOX and SOX Primary 

Review Panel (Panel). Over the next two to three years, the Panel will provide advice and 

recommendations to the EPA Administrator on the scientific and technical aspects of the primary 

(health-based) policy-relevant science and the NAAQS for both NOX and SOX. Specifically, this 

will involve the Panel’s review of EPA’s updated draft Integrative Science Assessment (ISA) for 

NOX and SOX health effects; and subsequently, as the basis for possible revisions to the primary 

NAAQS for NOX and SOX, the Primary NOX and SOX Risk/Exposure Assessment (RA), and the 
Primary NOX and SOX Policy Assessment (PA) to be published as an advance notice of proposed 

rulemaking (ANPR). This memo provides background information on this Panel, and addresses 

the following determinations: 

(A) The type of review body that will be used to conduct the review, the name of the Panel, 

and identification of the Panel Chair; 

(B) The types of expertise needed to address the general charge; 

(C) Financial conflict of interest considerations, including identification of parties who are 

potentially interested in or may be affected by the topic to be reviewed;

(D) How regulations concerning “appearance of a lack of impartiality,” pursuant to 5 C.F.R. 

§ 2635.502 apply to members of the Panel; and 

(E) How individuals were selected for the Panel. 

DETERMINATIONS: 

(A)The type of review body that will be used to conduct the review, the name of the Panel, 

and identification of the Panel Chair.

The CASAC, augmented by additional subject-matter experts, known collectively as the 

CASAC NOX and SOX Primary Review Panel, will conduct the ongoing review of, and offer 

advice and recommendations to the EPA Administrator concerning, the primary (health-based 

NAAQS for NOX and SOX. Dr. Rogene Henderson, the CASAC Chair, will chair this Panel.

The CASAC NOX and SOX Primary Review Panel will comply with the provisions of FACA and 

all appropriate SAB Staff Office procedural policies. 

(B) The types of expertise needed to address the general charge.

Per the solicitation for nominees to form the CASAC NOX and SOX Primary Review 

Panel that was published in the Federal Register on August 7, 2006 (see citation above), 

recognized, national-level experts were sought in one or more of the following six (6) disciplines 

to augment the expertise of the statutory CASAC:

(a) Atmospheric Science. Expertise in physical/chemical properties of nitrogen oxides 

and sulfur oxides and atmospheric processes involved in the formation, transport on urban to 

global scales, transformation of these pollutants in the atmosphere, and movement of the 

pollutants between media through deposition and other such mechanisms. Also, expertise in the 

evaluation of natural and anthropogenic sources and emissions of nitrogen oxides and sulfur 

oxides and resulting ambient levels due to natural sources, pertinent monitoring or measurement 

methods for these pollutants, and spatial and temporal trends in their atmospheric concentrations. 

(b) Exposure and Risk Assessment/Modeling. Expertise in measuring human population 

exposure to nitrogen oxides and sulfur oxides and/or in modeling human population exposure to 

pollutants from ambient and indoor sources. Expertise in human health risk analysis modeling 

for nitrogen oxides and sulfur oxides related to respiratory and other non-cancer health effects. 

2 
 (c) Dosimetry. Expertise in evaluation of the dosimetry of animal and human subjects, 

including identification of factors determining differential patterns of inhalation and/or 

deposition/uptake in respiratory tract regions that may contribute to differential susceptibility of 

human population subgroups and animal-to-human dosimetry extrapolations. 

(d) Toxicology. Expertise in evaluation of experimental laboratory animal studies and in

vitro studies of the effects of sulfur oxides and/or oxides of nitrogen on pulmonary and extrapulmonary (e.g., cardiovascular, immunological) endpoints. 

(e) Controlled Human Exposure. Expertise in evaluations of controlled human exposure 

studies of the effects of nitrogen oxides and sulfur oxides on health and compromised (e.g.,

having pertinent preexisting disease such as asthma) human adults and children, including 

physicians with experience in the clinical treatment of asthma and chronic lung diseases. 

(f) Epidemiology and Biostatistics. Expertise in epidemiologic evaluation of the effects 

of exposures to ambient nitrogen oxides and sulfur oxides and/or other major air pollutants (e.g.,

particulate matter, ozone, carbon monoxide) on human population groups, including mortality 

and morbidity effects (e.g., respiratory symptoms, lung function decrements, asthma medication 

use, emergency department visits, respiratory-related hospital admissions). Also, expertise in 

associated biostatistics and/or health risk analysis.

(C)Financial conflict of interest considerations, including identification of parties who are 

potentially interested in or may be affected by the topic to be reviewed.

(a) Identification of parties who are potentially interested in or may be affected by the 

topic to be reviewed: The principal interested and affected parties for this topic are: (1) EPA;

(2) State, regional and local air program (or air pollution control) agencies, and State regulatory 

officials; (3) State and local health officials; (4) research universities; (5) environmental interest 

groups/non-Governmental organizations (NGOs); (6) potentially responsible parties (PRP) and 

their contractors; and (7) various industry sectors interested in, or affected by, the current or any 

revised NAAQS for NOX and SOX, including the power-generating and automotive industries. 

(b) Conflict of interest considerations: For Financial Conflict of Interest (COI) issues, 

the basic 18 U.S.C. § 208 provision states that: “An employee is prohibited from participating 

personally and substantially in an official capacity in any particular matter in which he, to his 

knowledge, or any person whose interests are imputed to him under this statue has a financial

interest, if the particular matter will have a direct and predictable effect on that interest 

[emphasis added].” For a conflict of interest to be present, all elements in the above provision 

must be present. If an element is missing the issue does not involve a formal conflict of interest; 

however, the general provisions in the appearance of impartiality guidelines must still apply and 

need to be considered. 

(i) Does the general charge to the CASAC NOX and SOX Primary Review Panel 

involve a particular matter? A “particular matter” refers to matters that “...will involve 

deliberation, decision, or action that is focused upon the interests of specific people, or a discrete 

and identifiable class of people.” It does not refer to “...consideration or adoption of broad 

policy options directed to the interests of a large and diverse group of people.” [5 C.F.R. § 

2640.103 (a)(1)]. A particular matter of general applicability means a particular matter that is 

3 
focused on the interests of a discrete and identifiable class of persons, but does not involve 

specific parties. [5 C.F.R. § 2640.102 (m)]. 

The CASAC NOX and SOX Primary Review Panel’s activity in addressing the charge 

for the peer review of the draft NOX and SOX Primary ISA, RA and PA and related technical 

support documents will qualify as a particular matter of general applicability because the 

resulting advice will be part of a deliberation, and under certain circumstances the advice could 

involve the interests of a discrete and identifiable class of people but does not involve specific 

parties. That group of people constitutes those who are associated or involved with the 

potentially interested or affected parties, as identified in Section (3)(a) above. 

(ii) Will there be personal and substantial participation on the part of Panel 

members? Participating personally means direct participation in this review. Participating 

substantially refers to involvement that is of significance to the matter under consideration. [5 

C.F.R. § 2640.103(a)(2)]. For this review, the EPA Science Advisory Board (SAB) Staff Office 

has determined that CASAC NOX and SOX Primary Review Panel members will be participating 

personally in the matter. Panel members will be providing the Agency with advice and 

recommendations that is expected to include an assessment as to whether the proposed air 

quality criteria (by means of the ISA) accurately reflect the latest scientific knowledge useful in 

indicating the kind and extent of all identifiable effects on public health or welfare which may be 

expected from the presence of these pollutants (that is, NOX or SOX) in the ambient air. 

Therefore, participation in this review will also be substantial. 

(iii) Will there be a direct and predictable effect on CASAC NOX and SOX Primary 

Review Panel members’ financial interest? A direct effect on a participant’s financial interest 

exists if “...a close causal link exists between any decision or action to be taken in the matter and 

any expected effect of the matter on the financial interest. ...A particular matter does not have a 

direct effect ...if the chain of causation is attenuated or is contingent upon the occurrence of 

events that are speculative or that are independent of, and unrelated to, the matter. A particular 

matter that has an effect on a financial interest only as a consequence of its effects on the general 

economy is not considered to have a direct effect.” [5 C.F.R. § 2640.103(a)(i)] A predictable 

effect exists if, “...there is an actual, as opposed to a speculative, possibility that the matter will 

affect the financial interest.” [5 C.F.R. § 2640.103(a)(ii)] 

(D) How regulations concerning “appearance of a lack of impartiality,” pursuant to 5 C.F.R. 

§ 2635.502, apply to members of the Panel.

The Code of Federal Regulations at 5 C.F.R. § 2635.502(a) states that: “Where an 

employee knows that a particular matter involving specific parties is likely to have a direct and 

predictable effect on the financial interest of a member of his household, or knows that a person 

with whom he has a covered relationship is or represents a party to such matter, and where the 

person determines that the circumstances would cause a reasonable party to such matter, and 

where the person determines that the circumstances would cause a reasonable person with 

knowledge of the relevant facts to question his impartiality in the matter, the employee should 

not participate in the matter unless he has informed the agency designee of the appearance 

problem and received authorization from the agency designee.” Further, § 2635.502(a)(2) states 

that, “An employee who is concerned that circumstances other than those specifically described 

4 
in this section would raise a question regarding his impartiality should use the process described 

in this section to determine whether he should or should not participate in a particular matter.” 

To ascertain whether there is any appearance of a lack of impartiality, the following five 

questions will be posed to each member of CASAC and prospective members of the NOX and 

SOX Primary Review Panel with respect to the forthcoming charge for the Panel: 

(a) Do you know of any reason that you might be unable to provide impartial advice on 

the matter to come before the CASAC NOX and SOX Primary Review Panel or any reason that 

your impartiality in the matter might be questioned? 

(b) Have you had any previous involvement with the review document(s) under 

consideration, i.e., EPA’s 1st Draft NOX and SOX Primary Integrated Science assessment — 

including authorship, collaboration with the authors, or previous peer review functions? If so, 

please identify and describe that involvement. 

(c) Have you served on previous advisory panels, committees or subcommittees (Federal 

or otherwise) that have addressed the topic under consideration? If so please identify those 

activities. 

(d) Have you made any public statements (written or oral) on the issue? If so, please 

identify those statements. 

(e) Have you made any public statements that would indicate to an observer that you 

have taken a position on the issue under consideration? If so, please identify those statements. 

(E) How individuals were selected for the Panel.

As described in Section (B) above, the SAB Staff Office announced the formation of the 

CASAC NOX and SOX Primary Review Panel in the Federal Register (71 FR 44695) on August 

7, 2006, and requested nominations for recognized, national-level experts in one or more of the 

six scientific/technical expertise areas delineated in Section (B) above to augment the expertise 

of the statutory CASAC. In response to that solicitation, as well as from other sources, the SAB 

Staff Office identified 27 experts for the Panel’s “Short List.”

In December 2006, the SAB Staff Office published the “Short List” in the form of an 

“Invitation for Comments” memorandum and posted this on the Panel’s page on the SAB Web 

site at: http://www.epa.gov/sab/panels/casac_nox_and_sox_primary_panel.htm. The purpose of 

the “Invitation for Comments” memo is to solicit comments from members of the public or the 

Agency with respect to any relevant information or other documentation that the SAB Staff 

Office should consider in the final selection of this Panel.

The SAB Staff Office received two (2) public comments on this Short List from 

individuals representing the following organizations (date): 

Clean Air Watch (January 12, 2007) 

Center for Science in the Public Interest (CSPI) (January 17, 2007) 

The SAB Staff Office Director makes the final decision about who serves on the CASAC 

NOX and SOX Primary Review Panel, based on all relevant information. This includes a review 

5 
of the member’s confidential financial disclosure form (EPA Form 3110-48) and an evaluation 

of a lack of impartiality. For the EPA SAB Staff Office, a balanced committee or panel is 

characterized by inclusion of 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 general 

charge. Specific criteria to be used in evaluating an individual Panel member 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 lack of impartiality; and (e) skills working in committees, subcommittees and 

advisory panels; and, for the Panel as a whole, (f) diversity of, and balance among, scientific 

expertise, viewpoints, etc.

On the basis of the above-specified criteria, the CASAC NOX and SOX Primary Review 

Panel is as follows: 

Members of the statutory (chartered) Clean Air Scientific Advisory Committee:

 1. Dr. Rogene Henderson, Lovelace Respiratory Research Institute (NM) – CASAC 

Chair

2. Dr. Ellis Cowling, North Carolina State University (NC) 

3. Dr. James D. Crapo, National Jewish Medical and Research Center (CO) 

4. Dr. Douglas Crawford-Brown, University of North Carolina at Chapel Hill (NC) 

5. Mr. Richard L. Poirot, Vermont Agency of Natural Resources (VT) 

6. Dr. Armistead (Ted) Russell, Georgia Institute of Technology (GA) 

7. Dr. Frank Speizer, Harvard Medical School (MA) 

 Additional CASAC NOX and SOX Primary Panel members: 

1. Dr. Ed Avol, University of Southern California (CA) 

2. Dr. John Balmes, University of California, San Francisco (CA)

3. Dr. Henry Gong, University of Southern California (CA) 

4. Dr. Terry Gordon, New York University School of Medicine (NY) 

5. Dr. Dale Hattis, Clark University (MA) 

6. Dr. Patrick Kinney, Columbia University, Mailman School of Public Health (NY) 

7. Dr. Steven Kleeberger, National Institute of Environmental Health Sciences (NC) 

8. Dr. Timothy Larson, University of Washington (WA) 

9. Dr. Kent E. Pinkerton, University of California, Davis (CA) 

10. Dr. Edward M. Postlethwait, University of Alabama at Birmingham (AL) 

11. Dr. Richard B. Schlesinger, Pace University (NY) 

12. Dr. Christian Seigneur, Atmospheric & Environmental Research, Inc. (CA) 

13. Dr. Elizabeth A. (Lianne) Sheppard, University of Washington (WA) 

14. Dr. George Thurston, New York University School of Medicine (NY) 

15. Dr. James Ultman, Pennsylvania State University (Emeritus) (PA) 

16. Dr. Ronald Wyzga, Electric Power Research Institute (CA) 

6
_________________________________________

Concurred:

/Signed/ April 2, 2007 

____________________________

Vanessa T. Vu, Ph.D. Date

Staff Director 

EPA Science Advisory Board (1400F) 

7