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Appendix C: Seafood HACCP Partnership Agreement
INTRODUCTION
The attached model is to serve as the basis for the negotiation of partnership
agreements between Food and Drug Administration (FDA) district or regional offices and
state or local regulatory agencies for the inspection of fish and fishery product
processors. It is a model and, as such, deviation from the prescribed language may be
necessary in some cases. However, its contents reflect the principles essential to any
such agreement.
This model was developed by a work group comprised of representatives of the FDA Center
for Food Safety and Applied Nutrition, the FDA Office of Regulatory Affairs, the Alaska
Department of Environmental Conservation, the Florida Department of Agriculture and
Consumer Services, the Maine Department of Agriculture, and the Virginia Department of
Agriculture and Consumer Services. It is consistent with the guidance provided in the
ORA-21 "Partnership Agreement" Guidance Document (1/23/96).
The central goal of seafood HACCP partnerships is the development of a network of
equivalent federal and state inspection efforts that collectively make up a cohesive
national program. Such a program makes possible: enhanced consumer protection through the
enforcement of the HACCP system of preventive controls; improved efficiencies through the
minimization of duplication of inspectional effort; national uniformity in the application
of food safety standards; and, a national data base of inspectional results. Moreover, the
program should enhance both the domestic and international credibility of U.S. seafood
products through proper recognition of all relevant regulatory inspections, i.e., the
combined federal-state inspections as recorded in the national data base.
In order for a national inspection program that is based on partnerships to be truly
cohesive, all of the parties to the partnerships must perform equivalent inspections.
Equivalency can only be achieved through consistency in: training; standards; inspection
procedures; and, reporting. In order for the program to be meaningful, combined inspection
frequencies must be adequate to provide public confidence in the product. There must also
be some level of joint inspections for the purpose of confirming equivalency. In order for
the effectiveness of the program to be determined and communicated to its stake holders, a
national data base of the inspection results must be established. These principles are the
basis of the following model partnership agreement.
The attached model contains required language, which should, with few exceptions, be a
part of all federal/state, seafood HACCP partnership agreements. It also contains optional
additional language, which can be used to tailor the agreement to local circumstances. In
particular, the optional additional language will be relevant if the parties wish to
include inspection of bivalve, molluscan shellfish processors in the partnership
agreement, an arrangement which may be desirable in some localities. Other issues may be
included in the agreement, or additional detail may be provided for the existing issues,
if desired.
Seafood HACCP Partnership Agreement
(Required Language)
- Agreement to Establish Partnership
The (district or region name) of
the Food and Drug Administration and the (state agency name) agree to establish a
partnership for the regulation of the fish and fishery products processing industry in
(state).
This agreement applies to fresh and saltwater fin fish, crustaceans, other forms of
aquatic life (including, but not limited to, alligator, frog, aquatic turtle, jellyfish,
sea cucumber, and sea urchin, and the roe of such animals) other than birds and mammals,
and to other mollusks (other than bivalve), where such animal life is intended for human
consumption. Such animal life is referred to in this agreement as "seafood" or
"fish and fishery products."
This agreement does not apply to the regulation of bivalve, molluscan shellfish, which
are covered under the National Shellfish Sanitation Program, a cooperative,
federal/state/industry program.
See also "Optional Additional Language"
- Partnership Purpose and Goals
- This agreement covers the period (insert period of agreement) and may be extended as
agreed upon by the parties.
- The anticipated outcomes of the partnership are:
- To promote the widespread inspection of processors of fish and fishery products based on
Hazard Analysis Critical Control Point (HACCP) principles.
- To provide enhanced protection to consumers of fish and fishery products by securing
industry compliance with the Seafood HACCP Regulation, the Current Good Manufacturing
Practices Regulation, and other applicable regulations and standards;
- To secure this compliance through adequate and credible inspectional coverage of the
fish and fishery products processing industry in the State of (name of state)
through a combined Federal/State inspection frequency of HACCP-based inspections of at
least once per year (i.e. a minimum frequency of once per year, with the actual inspection
frequency being risk-based);
- To foster uniform, consistent Federal/State application of the Seafood HACCP Regulation,
the Current Good Manufacturing Practices Regulation, and other applicable regulations and
standards to the benefit of consumers and the fish and fishery products processing
industry;
- To enable the development of a national data base of inspectional data from both Federal
and State inspections. The combined total number of consistent, state-of-the-art
inspections in the national data base will, among other things, foster domestic and
international confidence in U.S. fish and fishery products, including products from the
State of (name of state), and provide both Federal and State public
health authorities with a better understanding of the state of the industry;
Note:
Presently, it is expected that the national data base will be developed by FDA and state
partners completing data collection forms and faxing them to a central computer at
CFSAN/Office of Seafood. The forms will be received on a fax modem, enabling the data to
be merged with existing FDA data sets. The data will be accessible on-line by FDA district
offices and through periodic reports by state partners. FDA is in the process of
identifying data needs for the potential users of the data base (i.e., FDA headquarters
and field and state partners). In particular, there is a desire to minimize duplication of
and maximize integration with existing reporting and data handling.
- To improve the efficiency of both the Federal inspection program for fish and fishery
products and that of the State of (name of state) through complementary
activities that conserve resources and minimize duplication of effort;
- To improve the proficiency of Federal and State fish and fishery products inspection
personnel (inspectional personnel may include analysts involved in team inspections)
through joint training and inspection;
Note: FDA is in the process of developing a
certification process for FDA investigators and analysts performing seafood inspections,
and an equivalent process for state inspectors. When such a system is developed, it would
be appropriate to refer to it at this point in the agreement.
- To foster the development and retention of both Federal and State expertise in the
inspection and regulation of fish and fishery product processors, and, through training,
sharing of information, and other cooperative activities, to help both Federal and State
regulators keep pace with new developments and technologies in fish and fishery product
processing and the regulation of fish and fishery product processing; and,
- To facilitate timely, accurate regulatory decisions through improved communications
between the (district or region name) and (state agency name) and through the prompt
sharing of policy and other regulatory information;
See also "Optional Additional Language"
- Program Areas and Activities for Partnership
- Program areas for partnership include:
- Inspections of fish and fishery product processors to ensure conformance with the
requirements of the Seafood HACCP Regulation, the Current Good Manufacturing Practices
Regulation, and other applicable regulations and standards;
- Exchange of inspectional and analytical data relating to processors of fish and fishery
products;
- Sharing of policy and other regulatory information between the (district or
region name) and (state agency name);
- Regulatory follow-up to noncompliance with the requirements of the Seafood HACCP
Regulation, the Current Good Manufacturing Practices Regulation, and other applicable
regulations; and,
- Training and joint inspection activities for seafood processor inspection personnel
(inspection personnel may include analysts involved in team inspection).
Note: FDA
is in the process of developing a certification process for FDA investigators and analysts
performing seafood inspections, and an equivalent process for state inspectors. When such
a system is developed, it would be appropriate to refer to it at this point in the
agreement.
- Cooperating Agency Contacts:
FDA
(name and title of FDA contact)
Date ______________
(name of state)
(name and title of state contact)
Date ______________
- Statutory Basis for Partnership Agreement:
FDA
Federal Food, Drug, and Cosmetic Act: Section 301 *****
Public Health Service Act: *****
21 Code of Federal Regulations: Parts 110, 113, 114, 123
(name of state)
(state statutes, regulations, ordinances)
See also "Optional Additional Language"
- Responsibilities
- Joint:
- Each party will provide to the other its establishment inventories of fish and fishery
product processors in the State of (name of state), on an annual basis,
to produce a combined list.
- The parties will conduct annual joint planning meetings to develop annual inspection
work plans, discuss joint and independent projects, and evaluate the effectiveness of the
agreement.
- The parties will conduct joint emergency meetings when requested by either party.
- Each party will ensure that its inspection personnel (inspection personnel may include
analysts involved in team inspections) that are involved in work under this agreement are
adequately trained (i.e. the principles of HACCP and the requirements of the Seafood HACCP
Regulation [e.g. the Alliance HACCP course, or equivalent], and the performance of a HACCP
inspection [e.g. the Regulator HACCP course]). In addition, each party will strive to
provide training in food science and microbiology (i.e. the FDA Food Microbiological
Control course, or equivalent) and in evidence development and interviewing technique, to
its inspection personnel (inspection personnel may include analysts involved in team
inspections) that are involved in work under this agreement.
Note: FDA is in the
process of developing a certification process for FDA investigators and analysts
performing seafood inspections, and an equivalent process for state inspectors. When such
a system is developed, it would be appropriate to include it as a requirement at this
point in the agreement.
Note: Explanation of "strive for": It is likely
that the FDA food microbiology course, or its equivalent,
will be a requirement for FDA certification of
inspection personnel. At such time, attendance at a food microbiology
course should be a requirement for performance of those seafood
HACCP inspections that are counted in the
national data base. FDA will work to provide the FDA Food Microbiology
Control course and training in interviewing technique and
evidence development in a manner that is accessible
to States in time to meet the likely certification requirement.
States should be encouraged to seek such training through
available sources in the interim.
- The combined efforts of FDA and (name of state agency) will result in
the inspection of all fish and fishery product processors in the state of (name of
state)at least annually in a manner consistent with the terms of this agreement.
Note:
This is a general statement of intent. More specific inspectional commitments are
contained in the FDA and state responsibilities sections. Federal/State work planning may
result in a dividing of the inventory between the agencies or, simply, inclusion of some
or all state inspections in the national data base. Some States are obligated to inspect
all registered establishments as a condition of registration.
There are various options available to the parties. For example, where a State inspects
several times a year, one of those inspections could become a full HACCP-based inspection
under the partnership and would therefore count in the national database, while the other
inspections could remain relatively abbreviated in nature. The State could decide to
reduce the number of abbreviated inspections it conducts a year on the grounds that one
full HACCP-based inspection reduces the need.
- FDA and (name of state agency) will jointly perform a minimum of 5% of
the inspections covered by this agreement. The joint inspections will serve training,
technology and information exchange, and verification functions.
- For each inspection that is covered by this agreement, the inspector will complete, at a
minimum:
- the Seafood HACCP Inspection Report;
- the Computer Generated Cover Sheet or similar document that contains, at a minimum: the
voluntary corrections taken by the processor; and, the final classification of the
inspection by the agency for each of the products inspected and for both compliance with
the Seafood HACCP Regulation and other applicable regulations (i.e. separate
classification for each); and,
- an FDA-483 or similar document that lists the specific violations noted during the
inspection.
Note: FDA is developing a HACCP-based inspection reporting form that States could
fax to FDA for consolidation into the national data base. The form will include data on
the status of the processor's HACCP program and administrative information relevant to the
inspection. The State version of the reporting form will contain all the critical data
from the Computer Generated Cover Sheet so that State inspectors will not have to complete
both.
- Each party will provide to the other a copy (i,e, electronic or hard copy) of each of
the above described documents.
- Voluntary or compulsory enforcement actions taken as a result of inspections conducted
by one agency (e.g. voluntary destructions, recalls, embargoes, seizures, prosecutions)
will be reported in a timely manner to the other agency
- Either party may elect to perform inspections or take enforcement actions as follow-up
to inspections or actions taken by the other party when deemed necessary, after
consultation with the other agency.
Note: This provision may be especially relevant
where a State does not adopt as its own the FDA Seafood HACCP Regulation but is willing to
conduct HACCP-based inspections as long as FDA takes any enforcement actions as a result
of those inspections.
- FDA and (name of state agency) will evaluate the effectiveness of the
agreement annually.
- FDA:
- FDA will develop, on an annual basis, a combined establishment inventory of fish and
fishery product processors, including their central file numbers, and provide it to (name
of state agency).
- FDA will provide training for FDA and (name of state) fish and fishery
product inspection personnel (inspection personnel may include analysts involved in team
inspections) in the performance of a HACCP inspection (i.e. the Regulator HACCP Course),
as needed. Note: FDA is working toward the development of CD-ROM-based, video-based, or
satellite-transmitted versions of the FDA Food Microbiology Control and introductory
regulatory training (e.g. evidence development, and interviewing technique) courses. When
completed they can be made available to state partners as part of this agreement.
- FDA will conduct at least (enter the appropriate number of inspections that are
to be performed by FDA under the terms of the agreement, but in no case less than 10% of
the fish and fishery products processors in the state) inspections of fish and
fishery product processors consistent with the terms of this agreement (exclusive of joint
inspections). Note: Reasons for requiring that FDA inspect at least 10% of the processors
include: maintaining FDA inspectional capacity in case the State's capacity is reduced, or
problems arise with the partnership; maintaining domestic and international credibility
through some FDA inspectional presence in each State; and maintaining intelligence about
the industry throughout the country.
- FDA will develop and provide to (name of state agency) quarterly data
summary reports on the number of inspections conducted under the terms of this agreement,
the voluntary actions taken by the processors, the final agency classifications, and a
summary of the Seafood HACCP Inspection Report findings.
- FDA will include State inspections conducted under this agreement in a national
inspection data base, which is reported to the public, the Congress, and to international
trading partners for trade purposes.
- (name of state agency):
- (name of state agency) will develop and implement inspection procedures
that are equivalent to those delineated in the Regulator HACCP course, the Domestic Fish
and Fishery Products Inspection Program, and the Investigations Operations Manual.
- (name of state agency) will conduct at least (enter the
appropriate number of inspections that are to be performed by the state under the terms of
the agreement, but in no case may the sum of the FDA and state inspections be less than
the total number of the fish and fishery products processors in the state)
inspections of fish and fishery product processors, consistent with the terms of this
agreement.
See also "Optional Additional Language"
- Planned Resources
- Funding
- Personnel:
- Development and maintenance of combined establishment inventory - FDA will provide
personnel necessary to accomplish this task.
- Generation of quarterly data summary reports - FDA will provide personnel necessary to
accomplish this task.
- Planning and assessment meetings - FDA and (name of state agency) will provide personnel
necessary to accomplish this task.
- Training -
- FDA and (name of state agency) will provide inspection personnel (inspection
personnel may include analysts involved in team inspections) to receive training
as follows: (list the number of FDA and state inspection personnel that will receive
training in introductory regulatory issues [e.g. evidence development, interviewing
technique], food science and microbiology [e.g. the FDA Food Microbiological Control
course, or equivalent], the principles of HACCP and the requirements of the Seafood HACCP
Regulation [e.g. the Alliance HACCP course, or equivalent], and the performance of a HACCP
inspection [e.g. the Regulator HACCP course].)
- FDA will provide facilitator(s) for the Regulator HACCP course.
- Inspections -
- FDA and (name of state agency) will provide investigators to perform inspections,
including joint inspections.
- Compliance - (describe the agency that will be responsible for regulatory follow-up
performed under this agreement)
See also "Optional Additional Language"
- Assessment Mechanisms
- Annually, FDA and (name of state agency) will review the quarterly data
summary reports to determine:
- The number of inspections conducted and the frequency of inspection;
- The types and frequency of HACCP violations noted;
- The percentage of inspections in the various classifications; and,
- The number and kind of voluntary and regulatory actions taken.
- Annually, FDA and (name of state agency) will review the results of the
joint inspections.
- Annually, FDA and (name of state agency) will review the results of
violative samples collected from processors covered by this agreement.
- Annually, FDA and (name of state agency) will determine the number and
percentage of FDA and (name of state agency) inspection personnel
(inspection personnel may include analysts involved in team inspections) that are
adequately trained
Note: FDA is in the process of developing a certification process
for FDA investigators and analysts performing seafood inspections, and an equivalent
process for state inspectors. When such a system is developed, it would be appropriate to
refer to it at this point in the agreement.
- FDA and (name of state agency) will prepare a written annual evaluation
at least annually.
- Conclusions and Recommendations
Signing of this agreement formalizes
the partnership between (name of district or region) and (name of
state agency) for the regulation of the fish and fishery products processing
industry. It becomes effective on the date of the last signature.
Based on the annual evaluations performed, the project coordinators will jointly
prepare options for follow-up agency actions, as appropriate, for approval by the
signatories to this agreement.
- Signatures of Responsible Parties (and Date signed)
For FDA:
(signature, name, and title of FDA representative)
Date _____________
For (name of State agency):
(signature, name, and title of State representative)
Date ______________
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