Guidance Documents
Chapter I General
Table of Contents
(.01 Evaluation Standards | .02 Procedures
for Initiating a New State Program Under the National Shellfish Sanitation
Program)
.01 EVALUATION STANDARDS
Background: 1995 Evaluation Standards Committee
As the result of an issue submitted at the 1994 ISSC annual meeting, the 1995
ISSC Evaluation Standards Committee was created. The Committee was charged with
reviewing the standards of the Evaluation Research Society and making a recommendation
to the ISSC as to whether these standards should be included in the NSSP and
the form the inclusion should take. The Committee reviewed these standards as
well as the American Evaluation Association's (AEA)
Guiding Principles for
Evaluators. The Committee recommended that the ISSC adopt the five principles
of the AEA. The Committee consensus was that these principles should apply to
all participants of the ISSC and should be included in the FDA state program evaluation
manual currently in development. The Committee also submitted a resolution to
the ISSC voting delegates recommending that the principles be adopted by the ISSC
and that FDA incorporate these principles into its state program evaluation manual.
The ISSC adopted the both the Committee's recommendation and resolution at its
1995 Annual meeting for use in the NSSP.
Evaluation Standards
In 1995, at its Annual Meeting, the ISSC adopted the following principles of the
American Evaluation Association and requested that the Food and Drug Administration
conduct its evaluations consistent with these principles.
- Systematic Inquiry: Evaluators conduct systematic, databased
inquiries about whatever is being evaluated.
- Competence: Evaluators provide competent performance to stakeholders.
- Integrity/Honesty: Evaluators ensure the honesty
and integrity of the entire evaluation process.
- Respect for People: Evaluators respect the security, dignity and self-worth of the respondents,
program participants, clients, and other stakeholders with whom they interact.
- Responsibilities for General and Public Welfare: Evaluators
articulate and take into account the diversity of interest and values that may
be related to the general and public welfare.
.02 PROCEDURES FOR INITIATING A NEW STATE PROGRAM
UNDER THE NATIONAL SHELLFISH SANITATION PROGRAM
The requirements of the NSSP are contained in its Model Ordinance. Implementation
of the Model Ordinance is a shared responsibility of federal, state, tribal
and local governments and the shellfish industry. The Model Ordinance establishes
the minimum requirements necessary to effectively manage and enforce an interstate
program, and is written for ease of legal adoption at all levels of government.
It is intended to be adopted by state and tribal regulators to address the
interstate movement of shellfish. The Model Ordinance provides a uniform legal
instrument for enforcement, better nationwide public health protection, and
facilitates the shipment of high quality shellfish in interstate commerce.
The ISSC provides the formal structure wherein state regulatory authorities,
with FDA concurrence, can change the Model Ordinance and establish other guidelines
and procedures for the sanitary control of the shellfish industry. For additional
Information concerning the origin of the Model Ordinance and the ISSC, see the
historical overview by Clem (1994) and the NSSP Guide for the Control of Molluscan
Shellfish (ISSC/FDA, 2002).
To ensure uniformity in the administration and implementation of the requirements
of the NSSP Model Ordinance at the state and tribal regulatory agency level,
the FDA reviews their programs on an annual basis. New state or tribal regulatory
programs under the NSSP are required to have their proposed program reviewed
prior to its initiation to assure that any shellstock produced under the state
or tribal program for movement in interstate commerce meets the requirements
of the Model Ordinance.
New State or Tribal Program
The Authority must apply to the FDA for evaluation and be found in conformity
with the NSSP before initiating a state or tribal shellfish sanitation program
or a new program element within an existing state or tribal program. The FDA
will act on any application submitted by the Authority within 30 days. If the
FDA has not acted within 30 days, the Authority may proceed with the new shellfish
sanitation program.
When two or more State or tribal agencies will be involved in the sanitary control
of the shellfish industry, a clear statement of each agency's responsibilities
should be developed in the form of a memorandum of understanding. This administrative
practice eliminates misunderstandings concerning agency responsibility and ensures
that all aspects of shared program responsibility are addressed.
States and tribes are responsible for maintaining shellfish programs that conform
to the requirements contained in the Model Ordinance. These requirements should
be mandatory within each State program.
References
Clem, David. 1994. Historical Overview. In:
Environmental Indicators and
Shellfish Safety. Eds. C.R. Hackney and M.D. Pierson. Chapman and Hall,
New York. pp. 1-29
Interstate Shellfish Sanitation Conference. 2002. NSSP Guide for the Control
of Molluscan Shellfish
. Interstate Shellfish Sanitation Conference,
209 Dawson Road, Suite 2, Columbia, South Carolina, 29223.
