Molluscan shellfish imports must meet both Federal and state requirements to gain free access to U.S. markets. Fresh and frozen oysters, clams, mussels, whole and roe-on scallops are required to meet the federal sanitation and labeling requirements applicable for all foods in the U.S. In addition, fresh and fresh frozen molluscan shellfish products must meet the specific temperature, microbiological, and identification standards contained in the NSSP. The NSSP standards have adopted into state law and enforced by both federal and state officials. The NSSP standards apply equally to both domestic and imported fresh and frozen shellfish.
The NSSP is a voluntary, tripartite program composed of state officials, the shellfish industry, and Federal agencies. FDA coordinates and administers the NSSP. In each participating state, one or more regulatory agencies manage the sanitation programs for domestic and imported shellfish. A foreign country may export molluscan shellfish to the U.S. by agreeing to abide by the NSSP. This agreement takes the form of a bilateral agreement or Memorandum of Understanding between the FDA and the foreign country. The Memoranda of Understanding on Shellfish Sanitation (MOU) stipulates the respective responsibilities of the exporting country and FDA in assuring that all provisions of the NSSP are met. After an MOU is signed, FDA conducts periodic program evaluations of the foreign country's program using the same criteria applied to state shellfish control programs.
Under the NSSP, the definition of shellfish is limited to molluscan bivalves - oysters, clams, mussels and whole or roe-on scallops. Thermally processed, hermetically sealed and cooked products are not regulated under the NSSP. However, all other oyster, clam, and mussel products which are not shelf stable at room temperature are covered by the NSSP.
Each participating state and country classifies its shellfish growing waters, inspects shellfish packing/shucking facilities and issues certificates (certifies) to individual shellfish dealers that meet NSSP control criteria. FDA evaluates state and foreign shellfish sanitation programs, insures standardization of laboratory procedures and coordinates shellfish research.
FDA publishes monthly the Interstate Certified Shellfish Shippers List (ICSSL) which consist of certified shellfish dealers. The NSSP member states require that only shellfish products from dealers listed in FDA's ICSSL be accepted. Individual state requirements under the Food Code, require that shellfish products be from a certified "source of origin." Proof of origin is dealer listing in the ICSSL. Products are rejected by states if they do not originate from a dealer listed in the ICSSL. In most cases, rejection does not require product testing. Once dealer certification is documented, product testing by FDA does not normally occur. However additional rejections may occur based on quality and safety monitoring performed by the receiving jurisdictions.
Environmental concerns are addressed by the National Marine Fisheries Service (NMFS). These concerns relate to the introduction and transfer of exotic species, aquatic disease organisms, and parasites that have the potential to adversely affect our domestic fisheries. The literature is replete with examples of introduced species and/or pathogenic agents, that in the absence of biological controls, have the ability devastate domestic fishery stocks either by producing epizootic outbreak of disease or through simple competition. Therefore, MOUs on shellfish sanitation require statements on environmental risks associated with the introduction of live and shells-on shellfish. Information on NMFS requirements should be directed to the following address:
FDA will only negotiate the development of a MOU with authorized officials representing the government of the exporting nation. Generally these governmental officials operate through a ministry of health, agriculture, or fisheries.
Product safety is primarily based on the sanitary evaluation of the production area and not on microbiological quality of shellfish meats. This is an important distinction.
The assessment of product safety based on water quality at the time of harvest is predicated on numerous assumptions and historical findings, including:
Water quality then, is determined by an ongoing program of bacteriological monitoring using indicators of fecal pollution. In addition, each shellfish growing area evaluation must include a pollution source survey of the shoreline and other areas adjacent to the shellfish growing waters. This inventory of potential shoreline pollution sources is designed to reveal that the area is not subject to direct contamination with small amounts of fresh sewage which would not ordinarily be revealed by the bacteriological examination." The pollution source survey, followed by routine microbiological testing at times of adverse pollution conditions represent the primary evaluation measures. The results of these surveys are then combined with hydrographic studies to detail how the pollution sources affect the water quality at the specific harvesting site.
The minimum satisfactory compliance criteria, guidelines, and public health explanations for the classification of shellfish growing waters are contained in the NSSP Guide for the Control of Molluscan Shellfish.
The NSSP also provides procedures that allow a participating nation to certify firms handling shellfish products that comply with NSSP criteria. This certification assures U.S. health officials both at the Federal and state levels, that shellfish products from a certified dealer have been grown, harvested, transported, processed, and shipped in accordance with NSSP criteria.
Simply stated, the NSSP certification system requires that all fresh and fresh frozen oysters, clams, and mussels in interstate commerce be tagged by a certified dealer. The certified dealer must hold, pack, and handle the product in accordance with NSSP sanitation controls at all times. The certified dealer must also maintain a file identifying the source of each lot of shellfish shipped in interstate commerce. This certification and record keeping provides sanitary controls and product traceability from harvest to sale. For the certification process to be effective, certified dealers must fully comply with these requirements.
Only those shellfish firms that meet the guidelines are eligible for certification and listing in FDA's monthly publication, the ICSSL. The ICSSL is a compilation of both domestic and foreign certified sources of molluscan shellfish that satisfactorily meet NSSP criteria.
A summary of the activities requiring governmental examination and shellfish shipper certification for listing in the ICSSL are:
Reshipping. This term refers to the purchase of shucked shellfish or shellstock from another certified dealer and selling the product without repacking or relabeling to other certified dealers, wholesalers, or retailers. The use of the reshipper classification is however, left to the option of the participating shellfish control authority.
The FDA Office of Seafood and the Division of Cooperative Programs, Office of Field Programs coordinates the assignment of FDA shellfish specialists who conduct annual program audits of participating international shellfish sanitation programs. Specific areas for evaluation include: 1) administrative and legal authority, 2) laboratory facilities, 3) plant sanitation and processing, 4) growing area classification, and 5) enforcement of harvesting controls. The points covered in the field program audit are summarized in Table 1, and are explained below.
| Administrative & Legal Authority | Laboratory | Plant Sanitation | Growing Water Classification and Patrol |
|---|---|---|---|
|
Effective State Laws and Regulations
Seizure/Embargo Powers Maintain Central Files Perform Internal Program Reviews Annually |
Follows APHA Procedures or Other NSSP Accepted Procedures
Bacteriological/Toxicological Proficiency Participates in FDA Quality Control Programs Qualified State Laboratory Evaluation Officer |
Certify and Inspect Interstate Shippers
Participates in Joint Inspections with FDA Regulates Shipping and Labeling Provides Effective Supervision of Depuration and Wet Storage Facilities |
Water Sampling and Classification Program
Operates Effective Marine Biotoxin Monitoring Program Effective Patrol of Closed Areas Necessary Measures are Taken To Make Classifications Known to the harvesters Provides Controls to Ensure that Only Shellfish Originating From Approved Waters Are Exported to U.S. |
FDA, in cooperation with the ISSC, developed a program to standardize the inspection and certification of shellfish dealers. The purpose of standardization is to train FDA and participating program shellfish plant inspectors in uniform inspection techniques. The prospective international participant should be aware that mandatory participation in the standardization training and testing program is a program requirement.
Historically, the shellfish sanitation program has found the coliform group of indicator organisms to be the most suitable medium for use when classifying shellfish growing waters. Bacteriological analyses however, must always be evaluated in the context of background information relating to the findings of a sanitary inspection of the surrounding shoreline. The minimum criteria for evaluating bacteriological sampling results includes the consideration of a series of samples collected over a period of time. Additionally, in order to validate the wholesomeness of the shellfish products, in shellfish growing areas affected by point sources of pollution samples must be collected under adverse conditions. Adverse conditions are defined as those meteorological, hydrographic, seasonal and pollution conditions that have been historically demonstrated to unfavorably influence a particular body of water. Therefore, in areas affected by point sources of pollution, the field monitoring program is required to 1) determine if adverse conditions exist that may significantly influence the growing area; and 2) if so, the classification decision is determined using only water sampling results that are collected during the adverse condition. In order to effectively establish the adverse condition and collect the minimum series of water samples, the conscientious environmental water sampling program usually operates during four (4) consecutive seasons (1 year) before the initial data analysis is completed. In shellfish growing areas which are not affected by point sources of pollution, a systematic random sampling (SRS) strategy may be substituted for the adverse monitoring strategy. SRS must meet the specific requirements outlined in the NSSP Guide for the Control of Molluscan Shellfish.
An FDA shellfish specialist will be assigned to your program to facilitate inquiries about participation in the NSSP. The FDA shellfish specialist can answer questions pertaining to all aspects of the program, from administrative to field topics. The shellfish specialist can aid a prospective NSSP participant by acquainting him/her with the appropriate NSSP guidelines and will facilitate the development of regulations and procedures. Also, the shellfish specialist is the primary FDA contact for state technical/training requests.
The letter of intent should be addressed to:
FDA will aid in the development and formally respond to the letter of intent to develop the bilateral agreement. The letter of intent must contain the commitment to initiate and operate the shellfish sanitation program, fund the travel and per diem of the applicant's program staffers in the U.S.; discuss the available funding sources for the travel and per diem of FDA technical specialists conducting on-site training in the applicant's country; and share the in-country travel expenses for FDA personnel conducting annual field audits after the applicant's shellfish sanitation program is accredited (Table 1). Please note, depending on the scope and breadth of the proposed shellfish sanitation program, training and evaluation arrangements, in addition to those shown on table 1, may be required.
FDA will formally respond to the letter of intent and will provide NSSP guideline and standards to the foreign country.
Depending on FDA's budgetary and staffing commitments, FDA will then proceed with training the applicant's personnel. Arrangements can then be initiated for the training of laboratory and water quality survey personnel (English speakers preferred) at FDA's facility. The training is provided free of charge, however, travel and per diem expenses will be the responsibility of the applicant. Training should be reserved for those program officials that will actually carry out the day-to-day operations of the applicant nation's shellfish sanitation program. (English speaking program personnel preferred, but not necessary when the services of a translator are available.) The training course agenda customarily requires 5 - 10 days of classroom and field study in the U.S. Laboratory and field monitoring training generally will not occur simultaneously. The classroom laboratory training and an on-site laboratory evaluation must be successfully completed before the bacteriological water quality monitoring for the classification of shellfish growing areas can begin.
Following a period for assimilation and trial of the NSSP accepted health controls, an FDA team will be scheduled for an on-site training and overview visit of the applicant nation. In the interim, the administrative controls should be developed via correspondence with the assigned FDA shellfish specialist. Initial development of the MOU may also begin during this period. The governmental public health authority should initiate the NSSP controls before the on-site training and overview visit. The on-site training and overview visit will identify any program weaknesses or deficiencies before the program operations are finalized.
Following the operation of the applicant's shellfish growing water monitoring program and acquisition of a data series meeting NSSP minimum criteria (generally one year) the tabulation and analysis of the sampling and sanitary reconnaissance data are compiled into a comprehensive survey sanitary report establishing the classification of the growing area(s). The completed sanitary survey reports are submitted to the assigned FDA Shellfish Specialist for evaluation prior to the scheduling of the pre-evaluation audit. FDA will evaluate the comprehensive report and if necessary, make recommendations to improve the operation of the program.
Upon confirmation that the newly developed shellfish sanitation program is ready to be evaluated, a second FDA team will be scheduled to appraise the program. FDA must conduct a through program audit and the applicant nation must successfully demonstrate that it possesses the administrative and technical capabilities to operate a comparable shellfish sanitation program. Only following the successful demonstration of its ability to run a shellfish sanitation program will the MOU be finalized.
Upon successful completion of this evaluation, the FDA Division of Cooperative Programs, Shellfish Safety Team will accept certifications of shellfish shipping firms to be included on the ICSSL. The time frame for completion of the process will vary according to the complexity of the applicant nation's program and availability of FDA technical assistance personnel.
Hypertext updated by dav 2001-FEB-13