Legal Context for Agency Peer Reviews Jamie Conrad Conrad Law - - PowerPoint PPT Presentation

SRA Annual Meeting W2-F: What’s New in Agency Peer Review

Legal Context for Agency Peer Reviews

Jamie Conrad Conrad Law & Policy Counsel December 11, 2013

Legal Issues

• Whether peer review is required
• Notice/open meetings
• Access to documents
• Panel Selection

2

Sources of “Law”

• U.S. Code (“statutes,” “laws”)
• C.F.R. (agency regs under these laws)
• OMB Peer Review Policy
• Agency peer review policies
• National Academies policies
• Administrative Conference of the U.S.

recommendations

• Authoritative bodies (e.g. Bipartisan Policy

Center)

3

Whether Required

• Statute may require on standing basis

– E.g., CASAC and NAAQS (42 U.S.C. § 7409(d)(2))

• Or on an ad hoc basis

– E.g., NAS review of NTP listing of styrene in 12th RoC (FY2012 HHS approps law)

• Otherwise not required

– OMB Peer Review Bulletin (agencies “shall” peer review influential scientific information they intend to disseminate) not enforceable by 3d parties

4

Notice/Access/Selection

• Completely different legal

frameworks apply to:

– Government-managed reviews

• Federal Advisory Committee Act (FACA)
• US Criminal Code/Ethics in Gov’t Act

– Contractor-managed reviews (not)

• FAR/Agency acquisition regs

5

FACA

• Applies if

1. Gov’t administers committee

• Ktor exception
• Subcommittee exception

2. Seeking consensus from reviewers

• Doesn’t apply to “letter review”
• Administered by GSA

– Burdensome, though much burden self- imposed

6

FACA

• Openness

–Prior notice of meetings in Fed Reg –Open meetings unless exemption invoked –Public can “attend, appear before or file statements with” –Public access to documents provided to or generated by panel

7

FACA

• Selection:

–Panelists must be “special government employees” –Panels must be “fairly representative”

• For scientific panels, of respected

scientific points of view

• NAS has own provisions; basically the

same except for closed meetings

8

Selection

• 18 U.S.C. § 219
• Ethics in Gov’t Act

–Office of Gov’t Ethics (OGE) rules

• Two main issues:

–Conflict of interest –Appearance of lack of impartiality

9

Conflict of Interest

• 5 C.F.R. Part 2635, Subpart D
• Can’t participate in:

– “particular matters” (vs. “broad policy options”) – with a “direct and predictable effect” – on a “financial interest”

• Current $ interests only

– No lookback – Stock ownership; typically not employment

10

Conflict of Interest

• No “potential” COIs
• Large body of OGE interpretation &

guidance

• Waivers allowed where gov’t need
• utweighs concern about COI

–NAS uses –SAB never does

11

Lack of Impartiality

• 5 C.F.R. Part 2635, Subpart E
• Can’t participate in:

– particular matter involving specific parties – affecting financial interests or covered relationships – if a reasonable person knowing relevant facts would question your impartiality

• Also, “other circumstances” involving a

particular matter that would raise impartiality concerns

– E.g., particular matter of gen’l applicability (fracking)

12

Process

• Confidential financial disclosure (e.g., EPA

Form 3110-48)

• SAB (gold standard)

– Solicit nominations in Fed. Reg. – Solicit comments on proposed panelists via Fed.

• Reg. notice
• Theoretically, this occurs after charge to panel

is finalized (not)

13

Contractor-Managed Reviews

• No requirements in FAR for

– Prior notice – Open meetings (usually don’t have) – Access to documents

• Selection process

– Uses different terminology (“potential conflicts of interest”) – Much less guidance

14

Contractor-Managed Reviews

• Not supervised by agency
• Source of numerous flaps

–Brominated flame retardants –Hexavalent chromium

• Perciasepe memo (May 3, 2013)

–Ktors must use same nomination/public comment process as SAB

15

Potential Reforms

• Require contractors to apply OGE ethics

terminology in selecting peer reviewers

• Bring all reviews up to SAB process for

reviewer selection

• Improve public participation opportunities

– More than 5 minutes at the end; able to engage panelists? – SAB invites panelists to engage commenters – IRIS process exploring > 5 minutes – Greater (some?) use of waivers

16