[Federal Register Volume 68, Number 178 (Monday, September 15, 2003)]
[Notices]
[Pages 54023-54029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23367]


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OFFICE OF MANAGEMENT AND BUDGET


Proposed Bulletin on Peer Review and Information Quality

AGENCY: Office of Management and Budget, Executive Office of the 
President.

ACTION: Notice and request for comments.

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SUMMARY: OMB requests comments on a proposed bulletin under Executive 
Order No. 12866 and supplemental information quality guidelines. As 
part of an ongoing effort to improve the quality, objectivity, utility, 
and integrity of information disseminated by the Federal Government to 
the public, the Office of Management and Budget (OMB), in coordination 
with the Office of Science and Technology Policy

[[Page 54024]]

(OSTP), proposes to issue new guidance to realize the benefits of 
meaningful peer review of the most important science disseminated by 
the Federal Government regarding regulatory topics. The proposed 
bulletin would be issued under the authority of Section 515 of the 
Treasury and General Government Appropriations Act for Fiscal Year 2001 
(Pub. L. 106-554; H.R. 5658); 44 U.S.C. 3504(d)(1), 3506(a)(1)(B); 
Executive Order No. 12866, as amended. Part I of the Supplementary 
Information below provides background and the request for comments. 
Part II provides the text of the proposed bulletin.

DATES: Interested parties should submit comments to the Office of 
Information and Regulatory Affairs (OIRA), Office of Management and 
Budget, at the address shown below on or before December 15, 2003.

ADDRESSES: Due to potential delays in OMB's receipt and processing of 
mail, respondents are strongly encouraged to submit comments 
electronically to ensure timely receipt. We cannot guarantee that 
comments mailed will be received before the comment closing date. 
Electronic comments may be submitted to: [email protected]. 
Please put the full body of your comments in the text of the electronic 
message and as an attachment. Please include your name, title, 
organization, postal address, telephone number, and e-mail address in 
the text of the message. Comments may also be submitted via facsimile 
to (202) 395-7245. Comments may be mailed to Dr. Margo Schwab, Office 
of Information and Regulatory Affairs, Office of Management and Budget, 
725 17th Street, NW., New Executive Office Building, Room 10201, 
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Dr. Margo Schwab, Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
725 17th Street, NW., New Executive Office Building, Room 10201, 
Washington, DC 20503 (tel. (202) 395-3093).

John D. Graham,
Administrator, Office of Information and Regulatory Affairs.

SUPPLEMENTARY INFORMATION: 

Part I--Background and Request for Comment

    A ``peer review,'' as used in this document for scientific and 
technical information relevant to regulatory policies, is a 
scientifically rigorous review and critique of a study's methods, 
results, and findings by others in the field with requisite training 
and expertise. Independent, objective peer review has long been 
regarded as a critical element in ensuring the reliability of 
scientific analyses. For decades, the American academic and scientific 
communities have withheld acknowledgement of scientific studies that 
have not been subject to rigorous independent peer review. Peer review 
``has been an essential part of the American science scene and one of 
the reasons why American science has done so well.'' Columbia 
University Provost Jonathon R. Cole (quoted in Abate, Tom, ``What's the 
Verdict on Peer Review?'' 21st Century, volume 1 (No. 1), Spring 1995, 
Columbia University); see also GAO Report, Peer Review Practices at 
Federal Science Agencies Vary, at 1 (March 1999) (``To help ensure the 
quality and integrity of the research, U.S. science has traditionally 
relied on independent reviews by peers.'').
    Independent peer review is especially important for information 
that is relevant to regulatory policies. Agencies often develop or fund 
the science that underlies their regulations, and then oversee the peer 
review of those studies. Unless the peer review is conducted with 
genuine independence and objectivity, this can create at least the 
appearance of a conflict-of-interest. For example, it might be thought 
that scientists employed or funded by an agency could feel pressured to 
support what they perceive to be the agency's regulatory position, 
first in developing the science, and then in peer reviewing it. 
Scientists with a financial interest in the subject matter of a study 
(e.g., ties to a regulated business) face a similar issue. Given that 
genuinely independent and objective peer review can provide a vital 
second opinion on the science that underlies federal regulation, the 
peer review of such information should be carried out under proper and 
clearly-articulated procedures.
    Scientists and government officials have recognized the importance 
of peer review in regulatory processes:
    [sbull] Joint Presidential/Congressional Commission on Risk 
Assessment and Risk Management: ``Peer review of economic and social 
science information should have as high a priority as peer review of 
health, ecological, and engineering information.'' Risk Assessment and 
Risk Management in Regulatory Decision-Making, vol. 2, at 103 (1997).
    [sbull] The National Academies' National Research Council: 
``[B]enefit-cost analysis should be subject to systematic, consistent, 
formal peer review.'' Valuing Health Risks, Costs, and Benefits for 
Environmental Decision Making, at 207 (1990).
    [sbull] Congress' General Accounting Office: ``Peer review is 
critical for improving the quality of scientific and technical products 
* * *'' GAO Testimony Before the House Subcommittee on Energy and 
Environment, Committee on Science, at 8 (Mar. 11, 1997).
    [sbull] Sally Katzen, Former Administrator of OIRA: Scientific 
inferences ``should pass muster under peer review by those in the same 
discipline, who should have an opportunity for such review to ensure 
that the underlying work was done competently and that any assumptions 
made are reasonable.'' Testimony Before the Environment, Energy, and 
Natural Resources Subcommittee of the House Committee on Government 
Operations (Feb. 1, 1994).
    In addition, many bipartisan legislative proposals have supported 
independent, external peer review. See, e.g., S. 343, the 
``Comprehensive Regulatory Reform Act of 1995;'' S. 1001, the 
``Regulatory Procedures Reform Act of 1995;'' S. 291, the ``Regulatory 
Reform Act of 1995;'' H.R. 1022, the ``Risk Assessment and Cost-Benefit 
Act of 1995.'' In 1999, for instance, a bipartisan coalition (including 
Senators Frist and Daschle, among many others) proposed to require 
agencies to conduct genuinely independent and transparent peer reviews 
of their most important risk assessments and cost-benefit analyses. See 
S. 746, the ``Regulatory Improvement Act of 1999.''\1\
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    \1\ This legislative proposal was sponsored by a bipartisan 
coalition of 21 Senators, including Senators Levin, Thompson, 
Daschle, Frist, Moynihan, Voinovich, Stevens, Rockefeller, Abraham, 
Breaux, Roth, Robb, Cochran, Lincoln, and Enzi.
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    Existing agency peer review mechanisms have not always been 
sufficient to ensure the reliability of regulatory information 
disseminated or relied upon by federal agencies. While most agencies 
have policies that require or encourage peer review, they do not always 
conduct peer review according to their own policies--even for major 
rulemakings. Indeed, an agency Inspector General recently found that 
although one agency had issued extensive agency peer review policies 
and mandates, ``[t]he critical science supporting the [agency's] rules 
was often not independently peer reviewed. Consequently, the quality of 
some science remains unknown.'' EPA OIG, Science to Support Rulemaking, 
at ii (Nov. 15, 2002) (emphasis supplied).
    Even when agencies do conduct timely peer reviews, such reviews are 
sometimes undertaken by people who

[[Page 54025]]

are not independent of the agencies, or are not perceived to be 
independent. Simply put, the agency proposing or supporting a 
regulation or study may not always be the best entity to commission or 
supervise its own peer review. Nonetheless, some agencies sometimes use 
their own employees to do peer reviews--a practice forbidden by other 
agencies' peer review manuals. See, e.g., Agency for Toxic Substances & 
Disease Registry Peer Review Policy (Mar. 1, 1996) (peer review is ``by 
outside (not ATSDR) expert scientists''); DOJ, Office of Juvenile 
Justice & Deliquency Prevention, Peer Review Guideline at 1 (``Peer 
review is * * * by experts from outside the Department''). As the 
National Academies' National Research Council has explained:

    External experts often can be more open, frank, and challenging 
to the status quo than internal reviewers, who may feel constrained 
by organizational concerns. Evaluation by external reviewers thus 
can enhance the credibility of the peer review process by avoiding 
both the reality and the appearance of conflict of interest.

Peer Review in Environmental Technology Development Programs: The 
Department of Energy's Office of Science and Technology 3 (1998) (``NRC 
Report'').
    The American Geophysical Union has likewise recognized that ``real 
or perceived conflicts of interest'' include the review of papers 
``from those in the same institution.'' AGU, Guidelines to Publication 
of Geophysical Research (Oct. 2000). Congress did the same in the 
Superfund legislation by providing that reviewers should not have 
``institutional ties with any person involved in the conduct of the 
study or research under review.'' 42 U.S.C. 9604(i)(13).
    When an agency does initiate a program to select outside peer 
reviewers for regulatory science, it sometimes selects the same 
reviewers for all or nearly all of its peer reviews on a particular 
topic. While this may be appropriate in limited circumstances, more 
often it could lead an observer to conclude that the agency continually 
selected the peer reviewers because of its comfort with them. This 
hardly satisfies the purposes and principles underlying independent 
peer review. Thus, the National Academies' National Research Council 
has stressed that even ``standing panels should have rotating 
membership terms to ensure that fresh perspectives are regularly 
replenished.'' NRC, Scientific Research in Education 138.
    It is also important to understand the relationship of the peer 
reviewers with the agency, including their funding history. A peer 
reviewer who is financially dependent on the agency, or at least hopes 
to profit financially from other dealings with the agency, may not 
always be completely independent, or appear truly independent. One 
agency's Inspector General has encouraged the agency to do a better job 
of ``consistently inquir[ing] whether peer review candidates have any 
financial relationship with [the agency].'' EPA OIG Report No. 1999-P-
217, at 10 (1999). Medical journals have similarly recognized the 
possibility that the receipt of significant funding from an interested 
entity can lead to bias, or the perception of bias, on the part of a 
reviewer. See ``Financial Associations of Authors,'' New England 
Journal of Medicine, vol. 346, 1901-02 (2002); Philip Campbell, 
``Declaration of Financial Interests,'' Nature, vol. 412, 751 (2001). 
But while some federal agencies are becoming more sensitive to peer 
reviewers' financial ties to private interests, most have not been as 
focused on reviewers' ties to the agency itself. See, e.g., Food & Drug 
Administration Guidance on Conflict of Interest for Advisory Committee 
Members, Consultants & Experts (Feb. 2000); National Institutes of 
Health Center for Scientific Review, Review Procedures for Scientific 
Review Group Meetings (Oct. 24, 2002).
    In addition to selecting independent and qualified peer reviewers 
for regulatory science, it is also essential to grant the peer 
reviewers access to sufficient information and to provide them with an 
appropriately broad mandate. In the past, some agencies have sought 
peer review of only narrow questions regarding a particular study or 
issue. While the scope of peer reviewers' responsibilities will 
necessarily vary by context, peer reviewers must generally be able to 
render a meaningful review of the work as a whole. As one agency's peer 
review handbook explains, a good charge to the peer reviewers is 
ordinarily one that both ``focuses the review by presenting specific 
questions and concerns'' the agency is aware of, and also ``invites 
general comments on the entire work product'' so as to ensure that the 
peer review is not hemmed in by inappropriately narrow questions. EPA 
Science Policy Council, Peer Review Handbook, Sec.  3.2.1 (2d ed. 
2000).
    Even when an agency solicits a comprehensive and independent peer 
review of regulatory science, the results are not always available for 
public scrutiny or comment. While a non-transparent peer review may be 
better than no peer review at all, public scrutiny of at least a 
summary of the peer reviewers' analyses and conclusions helps to ensure 
that the peer review process is meaningful and that the agency has 
fairly considered the peer reviewers' conclusions. Simply put, openness 
enhances the credibility of the peer review of regulatory science.
    For these reasons, the Fish and Wildlife Service and the National 
Oceanic and Atmospheric Administration have required that peer 
reviewers' reports and opinions be included in the administrative 
record for the regulatory action at issue. See Endangered & Threatened 
Wildlife and Plants: Notice of Interagency Cooperative Policy for Peer 
Review in Endangered Species Act Activities, 59 FR 34,270 (July 1, 
1994). The Agency for Toxic Substances and Disease Registry further 
requires that final research reports ``consider all peer review 
comments,'' and that the ``reasons for not adopting any peer reviewer's 
comment should be documented.'' Agency for Toxic Substances & Disease 
Registry Peer Review Policy at 5.
    While the peer review policies described above promote independent 
and transparent peer review, experience has shown that they are not 
always followed by all of the federal agencies, and that actual 
practice has not always lived up to the ideals underlying the various 
agencies' manuals. In the National Science and Technology Policy, 
Organization, and Priorities Act of 1976 (Pub. L. 94-282), Congress 
called on OSTP to serve as a source of scientific and technological 
analysis and judgment for the President with respect to major policies, 
plans, and programs of the Federal Government. Pursuant to the 1976 
Act, OSTP has evaluated the scale, quality, and effectiveness of the 
federal effort in science and technology, and has led interagency 
efforts to develop and to implement sound science and technology 
policies.
    The President and the Congress have also granted OMB the authority 
and responsibility to address agency peer review practices. Executive 
Order 12866, issued in 1993 by President Clinton, specifies in section 
1(b)(7) that ``[e]ach agency shall base its decisions on the best 
reasonably obtainable scientific, technical, economic, or other 
information concerning the need for, and consequences of, the intended 
regulation.'' The Executive Order further requires OMB to provide 
guidance to the agencies regarding regulatory planning. See id. section 
2(b).
    Similarly, the Paperwork Reduction Act requires the Director of OMB 
to ``develop and oversee the implementation of policies, principles, 
standards, and guidelines to * * *

[[Page 54026]]

apply to Federal agency dissemination of public information,'' and 
specifies that agencies are ``responsible for * * * complying with the 
* * * policies established by the Director.'' 44 U.S.C. 3504(d)(1), 
3506(a)(1)(B). In the Information Quality Act, Congress further 
specified that OMB's guidelines should ``provide policy and procedural 
guidance to Federal agencies for ensuring and maximizing the quality, 
objectivity, utility, and integrity of information (including 
statistical information) disseminated by Federal agencies.'' Pub. L. 
106-554, section 515(a).

Proposed Guidance

    OMB's current information quality guidance encourages but does not 
require peer reviews, and identifies general criteria that agencies 
should consider when they conduct such reviews. See Guidelines for 
Ensuring and Maximizing the Quality, Objectivity, Utility, and 
Integrity of Information Disseminated by Federal Agencies, 67 FR 8,452, 
8,454-55, 8,459-60 (Feb. 22, 2002). To best serve the President's 
policy of improving our federal regulatory system and the quality and 
integrity of information disseminated by the federal agencies, OMB, in 
coordination with OSTP, now proposes to ensure that agencies conduct 
peer reviews of the most important scientific and technical information 
relevant to regulatory policies that they disseminate to the public, 
and that the peer reviews are reliable, independent, and transparent. 
This notice seeks comment on the following proposed guidance, which 
would take the form of an OMB Bulletin, would supplement (but not 
replace) OMB's information quality guidelines pursuant to the 
Information Quality Act, Pub. L. 106-554, section 515(b), and would 
also serve as guidance pursuant to the Paperwork Reduction Act, 44 
U.S.C. 3504(d), and Executive Order 12866. OIRA will consult with OSTP 
in implementing this Bulletin as it relates to the peer review process.
    Many agencies already have extensive peer review requirements. This 
guidance would supplement those requirements for the peer review of 
``significant regulatory information,'' which is scientific or 
technical information that (i) qualifies as ``influential'' under OMB's 
information quality guidelines and (ii) is relevant to regulatory 
policies. This category does not include most routine statistical and 
financial information, such as that distributed by the Census Bureau, 
the Bureau of Labor Statistics and the Federal Reserve. Nor does it 
include science that is not directed toward regulatory issues, such as 
most of the scientific research conducted by the National Institutes of 
Health and the National Science Foundation. It is also limited to the 
peer review of studies to be disseminated, as opposed to applications 
for grants. In order to avoid duplication of effort, we have also 
exempted information that has already been adequately peer-reviewed 
from the peer review requirements of this Bulletin. Finally, OMB has 
excluded some categories of information, such as national security 
information, and some types of proceedings, such as individual 
adjudications and permit applications, from the scope of this Bulletin. 
The Bulletin also recognizes that waivers of these requirements may be 
required in some circumstances, such as when court-imposed deadlines or 
other exigencies make full compliance with this Bulletin impractical.
    This Bulletin requires peer review of the category of ``significant 
regulatory information'' described above. It also articulates specific 
requirements for the peer review of ``significant regulatory 
information'' that the agency intends to disseminate in support of a 
major regulatory action, that could have a clear and substantial impact 
on important public policies or important private sector decisions with 
a possible impact of more than $100 million in any year, or that the 
Administrator of OIRA determines to be of significant interagency 
interest or relevant to an Administration policy priority. Such an 
impact can occur whether or not a federal rulemaking is envisioned or 
considered likely to occur, in part because information might influence 
local, state, regional, or international decisions. For this category 
of especially important information, whose reliability is paramount, 
agencies must take care to select external peer reviewers who possess 
the requisite experience and independence from the agency. The agencies 
must also provide the peer reviewers with sufficient information and an 
appropriately broad charge. The agency must then publicly respond to 
the peer reviewers' written report, and make other appropriate 
disclosures.
    In addition to setting forth basic peer review procedures, this 
guidance also elaborates on the reporting requirements of Executive 
Order 12866 and the Information Quality Act. Pursuant to these 
authorities, agencies already provide OMB with information regarding 
upcoming regulatory initiatives and information quality issues. In 
doing so, each agency should make sure to identify: studies that will 
be subject to the peer review requirements of this Bulletin; the 
agency's plan for conducting the peer review; and correction requests 
filed by members of the public regarding the quality of information 
disseminated by the agency. These reporting requirements will permit 
the public, OMB, and OSTP to monitor agency compliance throughout the 
peer review process.
    Finally, this Bulletin provides that each agency that receives a 
non-frivolous administrative correction request challenging the 
agency's compliance with the Information Quality Act must promptly post 
the request on its Internet website or forward a copy to OIRA and, if 
requested, consult with OIRA regarding the request. This consulting 
requirement will assist OMB in discharging its responsibility under the 
Information Quality Act to monitor the quality of information 
disseminated to the public. Together with the peer review and reporting 
requirements discussed above, it should also give the public reasonable 
assurance that the most important regulatory science disseminated by 
the federal government comes with indicia of reliability.

Additional Requests for Comment

    OMB seeks comments from all interested parties on all aspects of 
this proposed Bulletin and guidelines. In particular, OMB seeks comment 
on the scope of this Bulletin. As explained above, this proposal covers 
significant regulatory information, with some exceptions. It may be 
that the overall scope of this Bulletin should be reduced or enlarged, 
or that fewer or more exceptions should be made.
    OMB also seeks comment on whether some provisions of this proposal 
should be strengthened, modified, or removed. While the bipartisan 
legislative proposal discussed above required all peer reviewers to be 
independent of the agency, this proposal leaves open the possibility 
that agency employees could serve on peer review panels in certain 
circumstances. This proposal also identifies circumstances that raise 
questions about the independence of peer reviewers (e.g., agency 
employees and agency-supported research projects), but it does not 
flatly preclude the selection of peer reviewers who raise some of those 
concerns. Members of the public are welcome to comment on whether these 
provisions strike the appropriate balance between safeguarding the fact 
and appearance of impartiality, on the one hand, and ensuring that 
qualified peer reviewers will not be precluded from service

[[Page 54027]]

based on unnecessarily stringent conflict-of-interest requirements, on 
the other. OMB is especially concerned about the government's need to 
recruit the best qualified scientists to serve as peer reviewers.
    For this reason, OMB also seeks comment on whether any of the 
provisions of this proposal would unnecessarily burden participating 
scientists or discourage qualified scientists from participating in 
agency peer reviews. Specifically, OMB seeks comment on whether peer 
reviewers' disclosure requirements should be limited to a specific 
numbers of years, perhaps to activities occurring during the previous 
five or ten years, instead of extending back indefinitely. More 
generally, OMB seeks suggestions regarding how agencies can encourage 
peer-review participation by qualified scientists.
    In addition, OMB seeks comment on whether agencies should be 
permitted to select their own peer reviewers for regulatory 
information. Although some observers may favor a system whereby a 
centralized body would appoint peer reviewers or supervise the details 
of the peer review process, OMB is not proposing such a system. Within 
the broad confines of this guidance, the agencies would retain 
significant discretion in formulating a peer review plan appropriate to 
each study. It is, however, arguable that an entity outside of the 
agency should select the peer reviewers and perhaps even supervise the 
peer review process. The latter approach might lend the appearance of 
greater integrity to the peer review process, but could be unduly 
inefficient and raise other concerns.
    Finally, OMB seeks comment from the affected agencies on the 
expected benefits and burdens of this proposed Bulletin. OMB believes 
that most agencies usually submit the types of studies covered by this 
Bulletin to at least some peer review. As a result, while this Bulletin 
should improve the quality of peer reviews, it may not impose 
substantial costs and burdens on the agencies that they are not already 
incurring. OMB seeks comment on this and all other aspects of this 
proposed Bulletin.

Part II--Proposed OMB Bulletin and Supplemental Information Quality 
Guidelines

Section 1. Definitions

    For purposes of this Bulletin and guidance:
    ``Administrator'' means the Administrator of the Office of 
Information and Regulatory Affairs.
    ``Agency'' has the meaning ascribed to it in the Paperwork 
Reduction Act, 44 U.S.C. 3502(1).
    ``Dissemination'' has the meaning ascribed to it in OMB's 
Guidelines for Ensuring and Maximizing the Quality, Objectivity, 
Utility, and Integrity of Information Disseminated by Federal Agencies, 
67 FR 8,452, 8,460 (Feb. 22, 2002) (``OMB's Information-Quality 
Guidelines'').
    ``The Information Quality Act'' means Section 515 of the Treasury 
and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 
106-554; H.R. 5658).
    ``Major regulatory action'' means the type of significant 
regulatory action that is defined in Section 1(f)(1) of Executive Order 
12866 and is not exempt from the requirements of that Order.
    ``Regulatory information'' means any scientific or technical study 
that is relevant to regulatory policy. Information is relevant to 
regulatory policy if it might be used by local, state, regional, 
federal and/or international regulatory bodies.
    ``Significant regulatory information'' means regulatory information 
that satisfies the ``influential'' test in OMB's Information-Quality 
Guidelines.
    ``Study'' refers broadly to any research report, data, finding, or 
other analysis.

Section 2. Peer Review of Significant Regulatory Information

    To the extent permitted by law, agencies shall have an appropriate 
and scientifically-rigorous peer review conducted on all significant 
regulatory information that the agency intends to disseminate. Agencies 
need not, however, have peer review conducted on studies that have 
already been subjected to adequate independent peer review. For 
purposes of this Bulletin, peer review undertaken by a scientific 
journal may generally be presumed to be adequate. This presumption is 
rebuttable based on a persuasive showing in a particular instance. In 
addition, agencies need not have peer review conducted on significant 
regulatory information that relates to national defense or foreign 
affairs, or that is disseminated in the course of an individual agency 
adjudication or proceeding on a permit application.
    During the planning of a peer review for significant regulatory 
information, the agency should select an appropriate peer review 
mechanism based on the novelty and complexity of the science to be 
reviewed, the benefit and cost implications, and any controversy 
regarding the science. Depending on these factors, appropriate peer 
review mechanisms for significant regulatory information can range from 
review by qualified specialists within an agency (if they reside in a 
separate agency program) to formal review by an independent body of 
experts outside the agency. The experts may be selected by the agency 
or an outside group.

Section 3. Additional Peer Review Requirements for Especially 
Significant Regulatory Information

    If significant regulatory information is subject to the peer review 
requirements of Section 2 of this Bulletin and (i) the agency intends 
to disseminate the information in support of a major regulatory action, 
(ii) the dissemination of the information could otherwise have a clear 
and substantial impact on important public policies or important 
private sector decisions with a possible impact of more than $100 
million in any year, or (iii) the Administrator determines that the 
information is of significant interagency interest or is relevant to an 
Administration policy priority, then, to the extent permitted by law, 
the agency shall have a formal, independent, external peer review 
conducted on the information. The peer review shall proceed in 
accordance with the following guidance:
    Selection of Peer Reviewers: Peer reviewers shall be selected 
primarily on the basis of necessary scientific and technical expertise. 
When multiple disciplines are required, the selected reviewers should 
include as broad a range of expertise as is necessary. When selecting 
reviewers from the pool of qualified external experts, the agency 
sponsoring the review shall strive to appoint experts who, in addition 
to possessing the necessary scientific and technical expertise, are 
independent of the agency, do not possess real or perceived conflicts 
of interest, and are capable of approaching the subject matter in an 
open-minded and unbiased manner. Factors relevant to whether an 
individual satisfies these criteria include whether the individual: (i) 
Has any financial interests in the matter at issue; (ii) has, in recent 
years, advocated a position on the specific matter at issue; (iii) is 
currently receiving or seeking substantial funding from the agency 
through a contract or research grant (either directly or indirectly 
through another entity, such as a university); or (iv) has conducted 
multiple peer reviews for the same agency in recent years, or has 
conducted a peer review for the same agency on the same specific matter 
in recent years. If it is necessary to select a reviewer who is or 
appears to be biased in order to obtain a panel with appropriate 
expertise, the agency shall ensure that

[[Page 54028]]

another reviewer with a contrary bias is appointed to balance the 
panel.
    Charge to Peer Reviewers: The agency shall provide to peer 
reviewers an explicit, written charge statement describing the purpose 
and scope of the review. The charge shall be appropriately broad and 
specific to facilitate a probing, meaningful critique of the agency's 
work product. Peer reviewers shall be asked to review scientific and 
technical matters, leaving policy determinations for the agency. This 
must be clearly stated and adhered to during the peer review process so 
the review is based solely on the science being evaluated. In addition, 
the agency shall be careful not to divulge internal deliberative 
information to the peer reviewers. The charge should generally frame 
specific questions about information quality, assumptions, hypotheses, 
methods, analytic results, and conclusions in the agency's work 
product. It should ask reviewers to apply the standards of OMB's 
Information-Quality Guidelines and the agency's own information quality 
guidelines. Where reviewers are expected to identify scientific 
uncertainties, they should generally be asked to suggest ways to reduce 
or eliminate those uncertainties.
    Information Access: The agency shall provide peer reviewers 
sufficient information to enable them to understand the data, methods, 
analytic results, and conclusions of the material to be peer reviewed, 
with due regard for the agency's interest in protecting its 
deliberative processes. Reviewers shall be informed of the 
reproducibility and other quality guidelines issued by OMB and federal 
agencies under the Information Quality Act. If the document is a formal 
regulatory analysis, reviewers should be briefed on the content of 
OMB's guidelines for regulatory analysis. If aspects of the agency's 
work are likely to be controversial, reviewers should be provided 
relevant background information on those potential sources of 
controversy.
    Opportunity for Public Comment: The agency shall provide an 
opportunity for other interested agencies and persons to submit 
comments. The agency shall ensure that such comments are provided to 
the peer reviewers with ample time for consideration before the peer 
reviewers conclude their review and prepare their report.
    Peer Review Reports: The agency shall direct peer reviewers of the 
regulatory information--individually or often as a group--to issue a 
final report detailing the nature of their review and their findings 
and conclusions. The peer review report shall also disclose the names, 
organizational affiliations, and qualifications of all peer reviewers, 
as well as any current or previous involvement by a peer reviewer with 
the agency or issue under peer review consideration. If there is a 
group report, any partial or complete dissenting statements should be 
included with the group's final report. The agency shall also provide a 
written response to the peer review report(s) explaining: The agency's 
agreement or disagreement with the report(s), including any 
recommendations expressed therein; the basis for that agreement or 
disagreement; any actions the agency has undertaken or proposed to 
undertake in response to the report(s); and (if applicable) the reasons 
the agency believes those actions satisfy any concerns or 
recommendations expressed by the report(s). The agency shall 
disseminate the final peer review report(s) and the agency's written 
statement of response in the same manner that it disseminates the work 
product that was reviewed. All of these written materials should be 
included in the administrative record for any related rulemakings.
    Consultation with OIRA and OSTP: Agencies shall consult with OIRA 
and OSTP concerning the sufficiency of their planned peer review 
policies. Upon request, an agency should discuss with OIRA how the 
agency plans to review a specific document covered by the Bulletin and 
whether such a plan is sufficient. This consultation is understood to 
serve as one of the pre-dissemination quality procedures envisioned by 
the Information Quality Act.
    Certification in Administrative Record: If an agency relies on 
significant regulatory information subject to the requirements of this 
section in support of a major regulatory action, it shall include in 
the administrative record for that action a certification explaining 
how the agency has complied with the requirements of this Bulletin and 
the Information Quality Act with respect to the significant regulatory 
information at issue.

Section 4. Peer Review Procedures

a. Federal Advisory Committee Act
    When considering selection of an outside panel of peer reviewers 
for regulatory information subject to the requirements of this 
Bulletin, an agency should assess the treatment of such a panel under 
the Federal Advisory Committee Act, and may retain a firm to oversee 
the peer review process with instructions to comply with principles 
consistent with those set forth in this Bulletin. See Byrd v. EPA, 174 
F.3d 239 (D.C. Cir. 1999) (holding that peer review panels selected and 
supervised by outside consultants are not governed by the Federal 
Advisory Committee Act, 5 U.S.C.S. App. II Sec. Sec.  1-15). Although 
such a firm can be engaged to oversee multiple peer review processes 
for an agency, the agency shall ensure that the firm itself possesses 
independence (and the appearance of independence) from the agency.
b. Agency Guidelines
    Based on this supplement to OMB's information quality guidelines, 
each agency shall supplement or amend its own information quality 
guidelines to incorporate the requirements of Sections 2 and 3 herein 
on a prospective basis, except that an agency need not amend its 
guidelines if there is no reasonable likelihood that the agency will 
disseminate information covered by the requirements of Sections 2 and/
or 3 of this Bulletin. In addition to incorporating these requirements, 
agencies should have specific guidelines as to what entanglements with 
agencies or affected businesses are so significant as to preclude an 
individual's participation as a peer reviewer, irrespective of other 
factors. Agency guidance should also address the following additional 
aspects of the peer review process, as well as any other matters they 
wish to address: the protection of confidential business information; 
any other needs for confidentiality in the peer review process 
(including any privacy interests of peer reviewers); and any types of 
information regarding the peer reviewers that should be publicly 
disclosed in addition to the information identified in Section 3 of 
this Bulletin (potentially including prior service as an expert 
witness, sources of personal or institutional funding, and/or other 
matters that might suggest a possible conflict of interest or 
appearance of a conflict of interest).
c. Waiver
    The Administrator may waive some or all of the peer review 
requirements of Sections 2 and/or 3 of this Bulletin if an agency makes 
a compelling case that waiver is necessitated for specific information 
by an emergency, imminent health hazard, homeland security threat, or 
some other compelling rationale. As appropriate, the Administrator 
shall consult with the Director of OSTP before deciding whether to 
grant a waiver.

[[Page 54029]]

Section 5. Interagency Work Group on Peer Review Policies

    The Administrator will periodically convene a meeting of an 
interagency group of peer review specialists and program managers, 
including the OSTP Associate Director for Science. The group may make 
recommendations regarding best peer review practices and may recommend 
other steps to expedite and improve agency processes.

Section 6. Reports on Agency Peer Reviews

    Each agency shall provide to OIRA at least once each year:
    [sbull] A summary description of any existing, ongoing, or 
contemplated scientific or technical studies that might (in whole or in 
part) constitute or support significant regulatory information the 
agency intends to disseminate within the next year; and
    [sbull] The agency s plan for conducting a peer review of such 
studies under the requirements of this Bulletin, including the 
identification of an agency contact to whom inquiries may be directed 
to learn the specifics of the plan.
    In order to minimize the paperwork involved, agencies should 
include this information in one of the periodic reports they submit to 
OMB under Executive Order 12866 or the Information Quality Act.

Section 7. Correction Requests Under the Information Quality Act

    The Information Quality Act requires OMB to issue guidance 
concerning administrative mechanisms by which members of the public may 
seek to obtain correction of information maintained and disseminated by 
an agency. See Pub. L. 106-554, section 515(b)(2)(B). OMB must also 
monitor the agencies' handling of such correction requests. See id.(C).
    In order to improve OMB's ability to assess the quality of 
information disseminated to the public and the adequacy of agencies' 
request-handling processes, an agency shall, within seven days of 
receipt, provide OIRA with a copy of each non-frivolous information 
quality correction request. If an agency posts such a request on its 
Internet website within seven days of receipt, it need not provide a 
copy to OIRA.
    Upon request by OIRA, each agency shall provide a copy of its draft 
response to any such information quality correction request or appeal 
at least seven days prior to its intended issuance, and consult with 
OIRA to ensure the response is consistent with the Information Quality 
Act, OMB's government-wide Information Quality Guidelines, and the 
agency's own information quality guidelines. The agency shall not issue 
its response until OIRA has concluded consultation with the agency. 
OIRA may consult with OSTP as appropriate if a request alleges 
deficiencies in the peer review process.

Section 8. Interagency Comment

    Interagency comment can assist in identifying questions or 
weaknesses in scientific and technical analyses. As part of its 
consideration of peer reviews, information quality correction requests, 
or major regulatory actions, OIRA may exercise its authority to request 
comment from other agencies. OIRA may make such comment public, or 
direct that it be included in the Administrative Record for any related 
rulemakings. Interagency comment may be conducted in addition to peer 
review, or may comprise the peer review required by Sections 2 and/or 3 
of this Bulletin if it is conducted in accordance with the requirements 
of this Bulletin.

Section 9. Effective Date and Existing Law

    The requirements of this Bulletin apply to information disseminated 
on or after January 1, 2004. The requirements are not intended to 
displace other peer review mechanisms already created by law. Any such 
mechanisms should be employed in a manner as consistent as possible 
with the practices and procedures laid out herein. Agencies may consult 
with OIRA regarding the relationship of this Bulletin with preexisting 
law.

[FR Doc. 03-23367 Filed 9-12-03; 8:45 am]
BILLING CODE 3110-01-P