These supplementary guidelines apply to scientific research
information that is officially used or produced by USDA agencies
or offices. The following information quality criteria
comprise the quality standards that USDA agencies and offices
will follow in developing and reviewing scientific research
information and disseminating it to the public. It should
be noted that in urgent situations that may pose an imminent
threat to public health or welfare, the environment, the national
economy, or homeland security these requirements may be waived
temporarily.
Objectivity of Scientific Research
Information
To ensure the objectivity of scientific research information
developed and disseminated by USDA, its agencies and offices
will:
- Require a clear statement of the research objectives
and a description of the approaches and methods used in
conducting the research.
- Subject the proposed research project(s) to a high quality
and objective review.
- Where applicable, ensure the quality of research through
the use of Good Laboratory Practices (40 CFR Part 160).
- Provide appropriate oversight to ensure that sound scientific
practices are followed.
- Adhere to the Research Misconduct Policy promulgated by
the Office of Science and Technology Policy on December
6, 2001, in the Federal Register (65 FR 76260). (See
http://www.ostp.gov/cs/home.)
- Provide research information to the public that is reliable,
accurate, and presented clearly.
- Provide an explanation that accompanies all research information
detailing how it was obtained, what it is, the conditions
to which it applies, and the limitations or reservations
that should be applied in using the information.
Before releasing scientific research information, USDA agencies
and offices will use one or more of the following procedures:
- Conduct a peer
review that meets the standards recommended by OMB.
- OMB's Information
Quality Bulletin for
Peer Review (PDF 238K)
- USDA's
Peer Review Guidelines (MS Word 62K)
- USDA's Internal Peer Review Templates
- Peer Review Plan
(Template) (MS Word 47K)
- Peer Review Annual
Report (Template) (MS Word 20K)
- 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.
- 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.
- 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.
- 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.
Objectivity of Influential
Scientific Research Information
To ensure the objectivity of influential scientific
information disseminated by USDA, its agencies and offices
will:
- Disseminate influential scientific information
with a high degree of transparency about data and methods
to facilitate its reproducibility by qualified third parties.
Reproducibility means that the information is capable
of being substantially reproduced, subject to an acceptable
degree of imprecision.
- With regard to original and supporting data related to
influential scientific information, USDA agencies
and offices will ensure reproducibility for those particular
types of data that can practicably be subjected to a reproducibility
requirement according to commonly accepted scientific standards,
given ethical, feasibility, or confidentiality constraints.
- With regard to analytic results related to influential
scientific information, USDA agencies and offices will ensure
sufficient transparency about data and methods that an independent
reanalysis could be undertaken by a qualified member of
the public unless other compelling interests such as privacy,
trade secrets, intellectual property, or other confidentiality
protections preclude such a reanalysis.
- In situations where public access to data and methods
will not occur due to other compelling interests, USDA
agencies and offices will apply especially rigorous
robustness checks to analytic results and document what
checks were undertaken.
- In all cases, USDA agencies and offices will disclose
the specific data sources, quantitative methods, and
assumptions used in the analysis.
With respect to influential scientific information
disseminated by USDA regarding analysis of risks to human
health, safety, and the environment, USDA agencies and offices
will ensure, to the extent practicable, the objectivity of
this information by adapting the quality principles found
in the Safe Drinking Water Act Amendments of 1996. The
agencies and offices will:
- Use the best available science and supporting studies
conducted in accordance with sound and objective scientific
practices, including peer-reviewed studies where available.
- Use data collected by accepted methods or best available
methods (if the reliability of the method and the nature
of the decision justifies the use of the data).
- In the dissemination of influential scientific
information about risks, ensure that the presentation of
information is comprehensive, informative, and understandable.
In a document made available to the public, specify,
to the extent practicable:
- Each population addressed by any estimate of applicable
effects.
- The expected risk or central estimate of risk for
the specific populations affected.
- Each appropriate upper-bound or lower-bound estimate
of risk.
- Each significant uncertainty identified in the process
of the risk assessment and studies that would assist
in reducing the uncertainty.
- Any additional studies, including peer-reviewed studies,
known to the agency that support, are directly relevant
to, or fail to support the findings of the assessment
and the methodology used to reconcile inconsistencies
in the scientific data.
Utility of Scientific Research
Information
To ensure the utility of the scientific research information
developed and disseminated by USDA, its agencies and offices
will:
- Depending on the purpose of the research, ensure that
the research is relevant to the needs of the agency's customers,
stakeholders, partners, or mission.
- When transparency of information is relevant for assessing
the information's usefulness from the public's perspective,
USDA agencies and offices will take care to ensure that
transparency has been addressed in its review of the information
before it is disseminated.
Integrity of Scientific Research
Information
To ensure the integrity of the scientific research information
developed and disseminated by USDA, its agencies and offices
will:
- Record and maintain, for an appropriate period of time,
all experimental results, data, and analytic procedures
needed to reproduce the released information in accordance
with established governmental standards or, where applicable,
widely recognized scientific practices.
- Protect the information from unauthorized access or revision
and ensure that the information is not compromised through
corruption or falsification.
- Adhere to the Research Misconduct Policy promulgated by
the Office of Science and Technology Policy on December
6, 2001, in the Federal Register (65 FR 76260). (See
http://www.ostp.gov/cs/home.)
http://www.ocio.usda.gov/qi_guide/scientific_research.html
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