Scientific Research

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, 239 KB)
• USDA Peer Review Guidelines (DOC, 67 KB)
• USDA's Internal Peer Review Templates
  - Peer Review Plan 
  - Peer Review Annual Report
• 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.)