**USDA Peer Review Implementation Guidelines**

**Purpose:** The purpose of this document is to implement the Office of
Management and Budget's (OMB) *Final Information Quality Bulletin for
Peer Review* (hereafter referred to as the Bulletin), which were issued
on December 16, 2004, and published in the *Federal Register* on January
14, 2005 (*FR 70:2664---2677*).

These supplementary peer review guidelines apply to influential
scientific information and highly influential scientific assessments
that contain findings or conclusions that represent the official
position of USDA agencies or offices and are officially disseminated to
the public at large. The following peer review guidelines comprise the
standards that USDA agencies and offices will follow in peer reviewing
influential scientific information and highly influential scientific
assessments before disseminating it to the public.

**Policy:** USDA will strive to ensure and maximize the quality,
objectivity, and integrity of influential scientific information and
highly influential scientific assessments that its agencies and offices
disseminate to the public. Agencies have the discretion to implement the
Bulletin and these guidelines as they determine appropriate with general
guidance from the Department.

**Definition of Scientific Information:** The term "scientific
information", as defined by the OMB Bulletin, means factual inputs,
data, models, analyses, technical information, or scientific assessments
related to such disciplines as the behavioral and social sciences,
public health and medical sciences, life and earth sciences,
engineering, or physical sciences. This includes any communication or
representation of knowledge such as facts or data, in any medium or
form, including textual, numerical, graphic, cartographic, narrative, or
audiovisual forms. This definition includes information that an agency
disseminates from a web page, but does not include the provision of
hyperlinks on a web page to information that others disseminate. This
definition excludes opinions, where the agency's presentation makes
clear that an individual's opinion, rather than a statement of fact or
of the agency's findings and conclusions, is being offered.

**Definition of Influential Scientific Information:** The term
"influential scientific information", as defined by the OMB Bulletin,
means information that the agency reasonably can determine will have or
does have a clear and substantial impact on important public policies or
important private sector decisions." In the term "influential scientific
information," the term \"influential\" should be interpreted
consistently with OMB\'s government-wide information quality guidelines
and USDA's information quality guidelines.

USDA's Information Quality Guidelines define a clear and substantial
impact as one that has a high probability of occurring. If it is merely
arguable that an impact will occur, or if it is a close judgment call,
then the impact is probably not clear and substantial. The impact must
be on \"important\" public policy or private sector decisions. Even if
information has a clear and substantial impact, it is not influential if
the impact is not on a public or private decision that is important to
policy, economic, or other decisions. The definition applies to
\"information\" itself, not to decisions that the information may
support. Even if a decision or action by a USDA agency or office is
itself very important, a particular piece of information supporting it
may or may not be \"influential.\"

In rulemaking, influential scientific information is information that
will have a clear and substantial impact on the resolution of one or
more key issues in an economically significant rulemaking, as that term
is defined in Executive Order 12866. Executive Order 12866 defines an
economically significant rulemaking as one that is likely to result in a
rule that may have an annual effect on the economy of \$100 million or
more or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public health
or safety, or State, local, or tribal governments or communities. The
reference to key issues on significant rules reflects the \"important\"
public policy language of the guidelines.

In non-rulemaking contexts, USDA agencies and offices will consider two
factors-breadth and intensity-in determining whether scientific
information is influential. Every decision USDA makes based on
disseminated information is important to someone. That does not mean
that disseminated scientific information used for each decision is
influential, as the term is used in these guidelines. In determining
whether scientific information is influential, under the Bulletin, USDA
agencies and offices should consider whether the information affects a
broad range of parties. Scientific information that affects a broad,
rather than a narrow, range of parties (e.g., an entire industry or a
significant part of an industry, as opposed to a single company) is more
likely to be influential. USDA agencies and offices also will consider
whether the scientific information has an intense impact. Scientific
information that has a low cost or modest impact on affected parties is
less likely to be influential than scientific information that can have
a very costly or crucial impact. Information that has an intense impact
on a broad range of parties should be regarded as influential.
Scientific information that affects a broad range of parties, with a
low-intensity impact, or scientific information that affects a narrow
range of parties, with a high intensity impact, likely is not
influential.

USDA agencies and offices may designate certain classes of scientific
information as \"influential\" or not in the context of their specific
programs. Absent such designations, USDA agencies and offices will
determine whether scientific information is influential on a
case-by-case basis, using the principles articulated in these
guidelines.

The \"influential\" designation is intended to be applied to scientific
information only when clearly appropriate. USDA agencies and offices
should not designate scientific, information as *influential* on a
regular or routine basis.

**Definition of Scientific Assessment:** The term "scientific
assessment", as defined by the OMB Bulletin, means an evaluation of a
body of scientific or technical knowledge, which typically synthesizes
multiple factual inputs, data, models, assumptions, and/or applies best
professional judgment to bridge uncertainties in the available
information. These assessments include, but are not limited to,
state-of-science reports; technology assessments; weight-of-evidence
analyses; meta-analyses; health, safety, or ecological risk assessments;
toxicological characterizations of substances; integrated assessment
models; hazard determinations; or exposure assessments.

**Definition of Highly Influential Scientific Assessment:** The term
"highly influential scientific assessment", as defined by the OMB
Bulletin, means information that the agency or the Administrator
determines to be a scientific assessment that could have a potential
impact of more than \$500 million in any year, or is novel,
controversial, or precedent-setting or has significant interagency
interest.

**Definition of Dissemination:** The term "dissemination", as defined by
the OMB Bulletin, means agency initiated or sponsored distribution of
information to the public (see 5 C.F.R. 1320.3(d) (definition of
"Conduct or Sponsor")). Dissemination does not include distribution
limited to government employees or agency contractors or grantees;
intra- or inter-agency use or sharing of government information; or
responses to requests for agency records under the Freedom of
Information Act, the Privacy Act, the Federal Advisory Committee Act,
the Government Performance and Results Act or similar law. This
definition also excludes distribution limited to correspondence with
individuals or persons, press releases, archival records, public
filings, subpoenas and adjudicative processes. The term "dissemination"
also excludes information distributed for peer review in compliance with
the Bulletin, provided that the distributing agency includes a clear
disclaimer on the information as follows: "This information is
distributed solely for the purpose of pre-dissemination peer review
under applicable information quality guidelines. It has not been
formally disseminated by \[the agency\]. It does not represent and
should not be construed to represent any agency determination or
policy." For the purposes of the Bulletin, "dissemination" excludes
research produced by government-funded scientists (e.g., those supported
extramurally or intramurally by federal agencies or those working in
state or local governments with federal support) if that information
does not represent the views of an agency. To qualify for this
exemption, the information should display a clear disclaimer that "the
findings and conclusions in this report are those of the author(s) and
do not necessarily represent the views of the funding agency".

**Peer Review Agenda:** Agencies shall clear peer review agendas for
influential scientific information and highly influential scientific
assessments through agency heads and inform policy officials within the
mission area prior to the agendas being made public. Each agency shall
post on its website, and link to the Department's website, an agenda of
peer review plans for influential scientific information and highly
influential scientific assessments. In the event that no items fall
within the categories of either influential scientific information or
highly influential scientific assessments, the agency will post a
negative agenda. Entries will initially be posted on June 16, 2005 for
highly influential scientific assessments and by December 16, 2005 for
influential scientific information. The websites shall be updated a
minimum of every six months thereafter.

**Peer Review Plan Format:** For each entry on the agenda the agency
shall describe the peer review plan. Each peer review plan shall be
consistent with instructions of Section V(2), Peer Review Plans, of the
Bulletin*.*

**Public Participation and Comment:** Agencies shall establish a
transparent process for public disclosure of peer review planning
related to influential scientific information and highly influential
scientific assessments, including a web-accessible description of the
peer review plan that the agency has developed for each of its
forthcoming influential scientific disseminations. Agencies shall
establish a mechanism for allowing the public to comment on the adequacy
of the peer review plans. Agencies shall consider public comments on
peer review plans.

Whenever feasible and appropriate, the agency shall make the draft of a
highly influential scientific assessment available to the public for
comment at the same time it is submitted for peer review (or during the
peer review process) and sponsor a public meeting where oral
presentations on scientific issues can be made to the peer reviewers by
interested members of the public. When employing a public comment
process as part of the peer review, the agency shall, whenever
practical, provide peer reviewers with access to public comments that
address significant scientific or technical issues. To ensure that
public participation does not unduly delay agency activities, the agency
shall clearly specify time limits for public participation throughout
the peer review process.

Agencies shall link their peer review agendas to the U.S. Government's
official web portal: *firstgov* at
[http://www.FirstGov.gov](http://www.FirstGov.gov/) when the website
becomes available.

**Adequacy of Peer Reviews for Influential Scientific Information:**
Before releasing influential scientific information, USDA agencies and
offices will use one or more of the following procedures:

1.  Conduct a peer review that meets the standards recommended by the
    OMB Bulletin*.*

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i.  Where appropriate, subject the information to formal, independent,
    external peer review to ensure its objectivity. If data and analytic
    results have been subjected to such a review, the information may
    generally be presumed to be of acceptable objectivity.  However, in
    accordance with the OMB standard, this presumption is rebuttable
    based on a persuasive showing by a petitioner in a particular
    instance, although the burden of proof is on the complainant.

ii. If agency-sponsored peer review is employed to help satisfy the
    objectivity standard, the review process should meet the general
    criteria for competent and credible peer review recommended by OMB.
     OMB recommends that (a) peer reviewers be selected primarily on the
    basis of necessary technical expertise, (b) peer reviewers be
    expected to disclose to agencies prior technical/policy positions
    they may have taken on issues at hand, (c) peer reviewers be
    expected to disclose to agencies their sources of personal and
    institutional funding (private or public sector), and (d) peer
    reviews be conducted in an open and rigorous manner.

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2.  Confirm that the information to be released has been peer reviewed
    by a reputable scientific or professional journal, and the journal
    has agreed to publish the same information.

3.  Conduct an internal review, which for the purposes of establishing
    transparency, ensures that the report or research product clearly
    states what the information and data are, how they were obtained,
    and any reservations or limitations on their use.

**Adequacy of Peer Reviews for Highly Influential Scientific
Assessments:** In addition to the requirements for influential
scientific information, highly influential scientific assessments must
meet the more stringent requirements as outlined in Section III of the
Bulletin*.*

**Alternative Procedures:** The alternative procedure(s) may be applied
to a designated report or group of reports as outlined in Section IV of
the Bulletin.

**Agency Responsibilities for Peer Review Implementation:** Agencies
will ensure that influential scientific information and highly
influential scientific assessments used to support regulatory documents
and other decisions, and that is disseminated, meets the requirements of
the Bulletin. Agency heads shall also be responsible for establishing an
appropriate process for implementation, reporting and clearance of
information related to these guidelines. Agencies should designate a
peer review coordinator.

**Annual Report:** Each agency shall provide to the Department by
December 1^st^ of each year, the information described in Section VI of
the Bulletin. This report will be submitted to the Office of Information
and Regulatory Affairs by December 16^th^ of each year.

**Regulatory:** Each agency that develops regulations that rely on
influential scientific information and or highly influential scientific
assessments must peer review that information. In addition, agencies
must identify at the workplan stage whether scientific information that
is influential or highly influential is being used. The Office of Budget
and Program Analysis will revise DR1512-1 and workplan forms to be in
compliance with the Bulletin.

**Exemptions, Deferrals, and Waivers:** The agency head may waive or
defer some or all of the peer review requirements of the Bulletin where
warranted by a compelling rationale. If the agency head defers the peer
review requirements prior to dissemination, peer review shall be
conducted as soon as practicable.

Agencies need not have peer review conducted on influential scientific
information and highly influential scientific assessments if they are
exempt as outlined in Section IX of the Bulletin.