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 a clear explanation of the analysis to the intended
audience.
- Providing transparent documentation of data sources, methodology,
assumptions, limitations, uncertainty, computations, and constraints.
- Explaining the rationale for using certain data over other
data in the analysis.
- Presenting the model or analysis logically so that the conclusions
and recommendations are well supported.
- 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.
http://www.ocio.usda.gov/qi_guide/regulatory.html
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