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Regulatory

These supplementary guidelines pertain to information disseminated to the public by USDA agencies and offices in conjunction with their regulatory activities, rulemaking activities, and program implementation activities that are subject to notice and comment procedures.  Such information includes economic, cost/benefit, scientific, environmental, risk assessment, reporting and record keeping, and other pertinent analyses prepared or presented by agencies in support of those activities.  Information that is subject to the guidelines under this section includes the following:

  • Economic analyses prepared in accordance with Executive Order 12866. 
  • Other cost/benefit analyses prepared in support of rulemaking efforts.
  • Scientific analyses (meaning natural sciences-plant pathology, animal physiology, etc.) and risk assessments prepared in support of agency rulemaking efforts as well as risk assessments of a non-regulatory nature.
  • Regulatory flexibility analyses or certifications of no significant impact prepared in accordance with the 1980 Regulatory Flexibility Act.
  • Environmental assessments, environmental impact statements, and associated documents prepared under the National Environmental Policy Act (NEPA).
  • Land and resource management plans, program and project-related information, and other documents prepared under the National Forest Management Act (NFMA).
  • Biological evaluations and biological assessments prepared to comply with the Endangered Species Act. 
  • Any other substantive analyses, documents, or procedures prepared in support of agency rulemaking activities or enforcement.

The following information quality criteria comprise the quality standards that USDA agencies and offices will follow in developing and reviewing regulatory 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 Regulatory Information

To ensure the objectivity of information disseminated by USDA agencies and offices in conjunction with their rulemaking activities, the agencies and offices will:

  • Use sound analytical methods in carrying out scientific and economic analyses and in preparing risk assessments.
  • Use reasonably reliable and reasonably timely data and information (e.g., collected data such as from surveys, compiled information, and/or expert opinion).
  • When using the best available data obtained from or provided by third parties, ensure transparency in its dissemination by identifying known sources of error and limitations in the data.
  • Evaluate data quality and, where practicable, validate the data against other information when using or combining data from different sources. 
  • Ensure transparency of the analysis, to the extent possible, consistent with confidentiality protections, by:
  • Presenting the model or analysis logically so that the conclusions and recommendations are well supported.
  • Explaining the rationale for using certain data over other data in the analysis.
  • Providing transparent documentation of data sources, methodology, assumptions, limitations, uncertainty, computations, and constraints.
  • Presenting a clear explanation of the analysis to the intended audience.
  • Clearly identify sources of uncertainty affecting data quality.
  • For quantitative assessments, clearly state the uncertainty of final estimates to the extent practicable.  Data and data collection systems should, as far as possible, be of sufficient quality and precision that uncertainty in the final estimates is appropriately characterized.
  • For qualitative assessments, provide an explanation of the nature of the uncertainty in the analysis.
  • Where appropriate, subject the analysis to formal, independent, external peer review to ensure its objectivity.  If 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 of the analysis is employed to help satisfy the objectivity standard, the review process should, where appropriate, 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 take 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.

Objectivity of Influential Regulatory Information

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 science and supporting studies conducted in accordance with sound and objective scientific practices, including peer-reviewed science and 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 Regulatory Information

To ensure the utility of information disseminated by USDA agencies and offices in conjunction with their rulemaking activities, the agencies and offices will take reasonable steps to:

  • Clearly state the purpose of the exercise and the intended recipients. 
  • Ensure, to the extent practicable, that the final product meets the needs of the intended recipients.

Integrity of Regulatory Information

To ensure the integrity of information disseminated by USDA agencies and offices in conjunction with their rulemaking activities, the agencies and offices will take reasonable steps to:

  • Ensure that the information is secure and protected from manipulation and/or falsification.
  • Protect against unauthorized internal and external access to the information.
  • Protect the confidentiality of individually identifiable information, in accordance with statutory requirements and Departmental directives.