Return to Seafood Regulations & Guidance
November 20, 2008
Report to Congress
Food and Drug Administration Amendments Act of 2007
Public Law 110-85
Section 1006 – Enhanced Aquaculture and Seafood Inspection
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
Table of Contents
- Section 1
- Seafood Inspections - General
- Domestic and Foreign Seafood Inspections
- Importers and Imports
- Aquacultured Seafood Inspections
- Molluscan Shellfish Inspections
- Seafood Inspections - General
- Section 2
- Seafood Traceability - General
- Traceability of Molluscan Shellfish
- Section 3
- Risks of Seafood Contaminants - General
- Risks of Banned Substances (New Animal (Aquaculture) Drugs)
Title X, section 1006 (c), of the Food and Drug Administration Amendments Act of 2007, Public Law 110-85 (FDAAA) requires the Secretary of the Department of Health and Human Services to submit a report to Congress that: "(1) describes the specifics of the aquaculture and seafood inspection program; (2) describes the feasibility of developing a traceability system for all catfish and seafood products, both domestic and imported, for the purpose of identifying the processing plant of origin of such products; and (3) provides for an assessment of the risks associated with particular contaminants and banned substances."
A. Seafood Inspections - General
Domestic and Foreign Seafood Processor Inspections
Processors of fish and fishery products are subject to the Food and Drug Administration's (FDA) Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, commonly known as the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, 21 CFR Part 123, which became effective in 1997. In short, this regulation requires both domestic and foreign processors of fish and fishery products to understand the food safety hazards[a] associated with their process and product and, through a system of preventive controls, to keep those hazards from occurring. An example of a potential food safety hazard is the misapplication of an approved aquaculture drug or the use of unapproved aquaculture drugs by processors of aquacultured fish. Under the Seafood HACCP Regulation, processors of aquacultured fish are expected to understand the hazard of unapproved drugs and put in place preventive controls to ensure that drug usage is legal and appropriate. The implementation of the Seafood HACCP Regulation provided significant advantages to both FDA and the seafood industry in creating an effective and efficient system for ensuring the safety of seafood, enhancing consumer confidence, and establishing a level playing field with world markets where HACCP-type controls were becoming the norm.
The regulation was promulgated under the Federal Food, Drug, and Cosmetic Act (FFDCA), including section 402(a)(1), which states that a food is adulterated if it bears or contains any poisonous or deleterious substance that may render it injurious to health, and section 402(a)(4), which states that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. It is important to recognize that the latter section, 402(a)(4) of the Act, addresses conditions that "may" render a food injurious to health, rather than conditions that have actually caused the food to be injurious.
The HACCP inspection approach, for the purpose of verifying compliance with the Seafood HACCP regulation, is used by FDA during domestic and foreign inspections of seafood processors to focus its attention on the parts of the process that are most likely to affect the safety of the product. In contrast to historical methods of evaluating processing practices on the day of the inspection, the HACCP approach allows FDA to evaluate processors' overall implementation of their HACCP systems over a period of time, by accessing the firms' HACCP Plans, and monitoring corrective actions and verification records. In this model, it is the seafood industry's responsibility to develop and implement HACCP controls and the regulatory agency's role to ensure that the industry complies.
It is also important to note that HACCP is only one element of FDA's inspection approach. The Seafood HACCP Regulation is complemented by other pre-existing regulations, including the Current Good Manufacturing Practice regulations, 21 CFR Part 110, which provide the basis for determining whether the products have been processed under sanitary conditions, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers and Acidified Food regulations, 21 CFR Parts 113 and 114, respectively, which specifically address the hazard of Clostridium botulinum in these products. Together, these regulations provide the regulatory food safety controls to which a processor of fish or fishery product is subject.
Every 3 years, FDA issues compliance programs that outline the agency's field staff's inspection responsibilities. The Domestic Fish and Fishery Products Compliance Program, 7303.842, and the Import Seafood Products Compliance Program, 7303.844, provide a priority list for inspection coverage based mostly on the risk or the potential for contamination of products that can cause serious harm to consumers. These were most recently revised in 2007 and 2006, respectively. Examples of high priority products include ready-to-eat products such as hot- or cold-smoked fish, scombrotoxin-forming fish such as tuna or mahi mahi, aquacultured seafood products, and fish packed in reduced oxygen packages.
Annually, FDA determines a work plan for each FDA district office that outlines the agency's field staff's domestic inspection responsibilities. This work plan focuses on seafood safety issues that are a priority for the agency and allocates available resources.
Although inspectional coverage is based primarily on risk-based product priorities as determined by relative likelihood and severity of potential food safety concerns, FDA district offices may adjust that coverage to include a particular establishment, such as one that may have been associated with a consumer complaint, or illness, or with a poor compliance history. For example, the work plan may dictate that a processor be inspected annually, but if the processor is found out of compliance during an inspection, re-inspection will occur more rapidly.
The regulatory sanctions that FDA has available to apply to domestic processors of fish and fishery products that are non-compliant are warning letters, seizure of products, injunction against further non-compliant practices, or prosecution of an individual or establishment.
There are approximately 13,400 domestic seafood processing establishments. The numbers of domestic seafood processor inspections[b] conducted by FDA during fiscal years (FY) 2004 through 2006 are as follows:
|Fiscal Year (FY)||No. of Inspections|
Occasionally, if inspections reveal questionable processing activities that cannot be resolved through an evaluation of HACCP records, samples of the processor's product may be collected and examined, or delivered to an FDA laboratory for analysis of the particular hazards or contaminants of concern. Examples of seafood analyses commonly conducted include microbiological examinations for pathogens, such as Listeria and Salmonella, and chemical analyses, such as unapproved food or color additives, filth, decomposition, histamine analysis, and contaminants such as pesticides, chemotherapeutic agents (drugs), and heavy metals. The number of analyses conducted on samples of seafood products collected in domestic commerce in recent years is shown in the following table:
|FY||Chemical Analyses||Microbiological Analyses||Total|
From FY 1999 through FY 2005, the compliance program directed that the field collect "verification samples" from firms classified by FDA as NAI ("No Action Indicated," signifying that no objectionable conditions were found during the inspection) after a HACCP inspection. The purpose of these sample analyses was to serve as a safety check mechanism to determine if product from an NAI HACCP firm was indeed "safe." After 6 years of verification sampling, the Office of Seafood determined that there was strong correlation between NAI HACCP inspections and "safe" seafood so verification samples were, except in very specific and uncommon circumstances, discontinued, which explains the decline in the total number of domestic sample analyses in FY 2006.
Foreign inspectional coverage is also based on product priorities as well as other country-specific factors, including the volume of seafood exported to the U.S., the history of violations associated with the products originating from the country, the outcome of previous inspections conducted of the seafood processors, the outcome of importer inspections, the credibility of information raising safety concerns with a foreign establishment's or country's exports, and the use of a new technology or process by processors that might raise food safety concerns. For example, countries or individual processors that process and export known high priority products such as vacuum packed raw fish, ready-to-eat fishery products, scombrotoxin-forming fish, aquaculture seafood, and molluscan shellfish are routinely targeted for inspection.
The regulatory options available for FDA with respect to foreign processors that are non-compliant include placing the affected products on Import Alert for detention without physical examination (DWPE), which means they are subject to detention and, unless they are demonstrated to be compliant, refusal of admission.
FDA has been conducting a limited number of foreign establishment inspections of seafood processors that ship to the U.S. each year since 1999. There are approximately 14,900 registered foreign firms that export seafood to the U.S. However, a great many more foreign firms are involved in the processing of the products that eventually are shipped to the U.S. Foreign inspections focus on the same high priority products that are highlighted for domestic coverage and are conducted in the same manner. However, the number of foreign inspections is small compared to the number of firms exporting to the U.S. and compared to domestic inspections.
The number of foreign countries visited and the number of seafood inspections conducted in those countries during FY 2004 through FY 2006 are as follows:
|FY||No. of Countries||No. of Inspections|
Note: FDA does not typically collect samples during inspections of foreign processing facilities.
Importers and Imports
FDA regulates imported seafood products by conducting foreign manufacturer inspections (as described above), by conducting inspections of importers, and by collecting surveillance samples of imported goods at the time of entry. FDA prioritizes these import-related activities based on the products with the greatest potential for contamination that can cause serious harm to consumers. High priority products, and foreign processors or importers of high priority products, are assigned higher priority for surveillance activities. Lower priority products, processors, and importers are sampled or inspected less frequently with remaining resources. Whether produced domestically or by a foreign firm, examples of high priority products are the same and include ready-to-eat products such as hot- or cold-smoked fish, scombrotoxin-forming fish, such as tuna or mahi mahi, aquacultured seafood products, and fish packed in reduced oxygen packages.
FDA inspections of foreign manufacturers will be facilitated by the placement of inspectional staff permanently within high priority countries/regions. An office was opened in China in 2008, and offices are planned for India and the Middle East. These offices will also facilitate coordination of food safety issues with the competent authorities in the countries/regions in which they are located, such as response to food-borne illnesses traced to imported product and technical assistance to foreign competent authorities and industries.
In 2008, FDA published final guidance on third party certification of food products. FDA envisions that existing third party certification bodies will certify imported products to FDA regulatory requirements, providing valuable additional information at time of entry to FDA's import regulatory staff about the life cycle of the product. The guidance describes the manner in which third party certification should be done in order that FDA might recognize that certification. Information from third party certification will enable FDA to focus its attention at the border on those products that are of higher risk and for which there is little or no information about the likelihood of its compliance with FDA requirements. In 2007, HHS/FDA signed an agreement with the government of China that is designed to lead to certification by China of products that meet FDA requirements, after FDA has verified the competency of the Chinese regulatory system.
It is the importer's responsibility to offer for entry into the U.S. products that are fully compliant with all applicable U.S. laws. Under the Seafood HACCP Regulation, HACCP controls are required for both domestic and foreign processors of fish and fishery products. Additionally, the regulation requires that U.S. importers take certain steps to verify that their foreign suppliers meet the requirements of the regulation.
The importer must meet its obligation by having and implementing written verification procedures for ensuring that fish and fishery products offered for entry into the U.S. were processed in accordance with the requirements of the regulation. Some verification steps taken by importers include: maintaining a copy of the foreign processor's HACCP plan along with the processor's written guarantee of compliance with the Seafood HACCP Regulation, inspecting the foreign processor's facilities to ensure compliance with the Seafood HACCP Regulation, and obtaining continuing or lot-by-lot certifications from an appropriate foreign government inspection authority certifying that the products are processed in compliance with the Seafood HACCP Regulation.
FDA assigns importer inspections using the same tools as domestic inspections—by identifying high priority products, developing a work plan, and giving instructions to the field through a compliance program. Importer inspections can also be assigned as follow-up to a violative import sample or as a result of compliance deficiencies found during a foreign processor's inspection.
There are approximately 2660 importers of seafood in the U.S. The numbers of inspections of U.S. importers of fish and fishery products during FY 2004 through FY 2006 are as follows:
|FY||No. of Inspections|
FDA's surveillance system for seafood imports has traditionally consisted of: reviews of prior notice data, reviews of customs entry forms for fish and fishery products being offered for entry into the U.S., physical or sensory analysis (field examinations), sample collections for laboratory analysis of products awaiting entry, and DWPE of products with a history of problems.
Selection of entries to examine or sample is based on the same hazard-based, high priority products described earlier or upon the introduction of a new product. Selection may also be influenced by FDA's regulatory experience and the history of violative product associated with such things as the country of origin, foreign processor, or importer.
In FY 2007, approximately 868,000 lines (entries) of fish and fishery products were submitted for importation into the U.S., and FDA examined or obtained samples from approximately 1.2 percent of those lines. Those line entries examined or sampled by FDA are routinely examined or analyzed for microbiological contamination, parasites, decomposition and histamine testing, chemical contaminants (e.g., pesticides, dioxin, methyl mercury, and heavy metals), food and color additives, filth, mold, foreign objects, unapproved new animal (aquaculture) drugs, packaging, and labeling. The type of examination and analysis depends on the product and the types of problems that have been encountered in the past associated with that product. FDA may increase sampling of certain products if current surveillance sampling detects a pattern of violative products from its source (country, foreign processor, or shipper). Increased sampling, via a sampling assignment or an Import Bulletin, beyond that which is assigned in the annual work plans may be initiated by the field or by FDA headquarters.
The number of examinations and analyses performed on imported samples in recent years is shown in the following table:
|FY||Field Exams*||Chemical Analyses||Microbiological Analyses||Total|
*A field exam is an examination of a product in the field for obvious defects that would be apparent without laboratory analysis. Examples are physical defects, such as rust or holes in containers or packaging, visible adulteration, such as from oil or chemicals, or defaced labels.
When FDA detects adulterated seafood or observes that an importer or foreign processor has failed to implement adequate safety (HACCP) controls, such that subsequent shipments appear to be adulterated, those subsequent shipments may be placed on DWPE when introduced for entry into the U.S. FDA uses a system of publicly accessible Import Alerts to provide information and instructions to FDA's field import review staff on how to process particular entries, including products that are subject to DWPE.
Products from firms listed on an Import Alert and subject to DWPE may be refused entry unless the owner or consignee of the goods can provide evidence to FDA that the seafood is not violative. In cases where FDA determines that a particular problem is widespread in a country or region, such that future shipments of products from that country or region appear to be violative, the agency may place all of a particular type of product from that country or region on an import alert for DWPE. FDA currently has 38 Import Alerts relating to seafood products.
As previously discussed, FDA's import surveillance system works in conjunction with FDA's enforcement of the Seafood HACCP Regulation. For example, the finding of non-compliant product during import surveillance can result in FDA scheduling an inspection of the importer or foreign processor.
B. Aquacultured Seafood Inspections
All substances used as new animal (aquaculture) drugs during the farming of seafood imported into the U.S. are required to be approved under Section 512 of the FFDCA. Unapproved new animal drugs administered in any dosage form (including via feed) to an animal are considered to be unsafe new animal drugs and are not allowed to be used. FDA approves new animal drugs for a specific species, condition of use, route of administration, dosage regimen, and withdrawal time. Labeled withdrawal times must be followed to ensure that no harmful drug residues are present in the edible tissue of the animal when it is harvested for human consumption. If the labeled withdrawal time is followed, the fish should be safe when offered for sale. Tissue residue tolerances may be established for FDA approved drugs. If there is no tolerance established, any amount of drug residue found is considered a violation and renders the product adulterated. The use of unapproved drugs or misuse of approved drugs in farm-raised seafood raises significant public health concerns. The application of these drugs during the various stages of aquaculture can result in the presence of the drugs or their metabolites in the edible portion of the aquaculture products. This may have an effect on the safety of these products for consumers because, for example, some of these drugs are associated with increased risk for cancer with prolonged exposure or antibiotic resistance in human pathogens.
The hazard associated with the application of new animal drugs on an aquaculture farm must be addressed in the processor's HACCP program. All domestic and foreign aquaculture seafood processors have the responsibility for establishing and implementing preventive controls for the aquaculture drug hazard.
Routine testing of chemotherapeutics in seafood (aquaculture drug residues) was initiated in February 2002 under the Chemotherapeutics in Seafood Compliance Program, 7304.018. The purpose of the program is collection and testing of samples of selected imported and domestic aquacultured seafood products to determine the presence of unapproved chemical compounds such as antibiotics and anti-fungal agents. The program's collection schedule is issued at the beginning of each fiscal year assigning specific domestic and import seafood products. Sampling priorities are given to products and sources that have previously been associated with violative products due to contamination with drug residues. The use of newly validated analytical methods for high priority drug residues may also be assigned top priority. Currently, testing for the following drug residues is included in the program: chloramphenicol, nitrofurans, fluoroquinolones, malachite green, crystal (gentian) violet, quinolones, ivermectin, methyltestosterone, and oxytetracycline.
Any seafood products containing unapproved new animal drug residues are considered to be adulterated under the FFDCA and are not permitted to be sold in, or imported into, the U.S. Such adulterated imported seafood products are subject to seizure or refusal of admission into the U.S. Products from foreign manufacturers or shippers who have been found to use unapproved drugs may be subject to DWPE by FDA and, if so, may be placed on an import alert for DWPE. There are currently four active Import Alerts (IA) specific to violations related to unapproved aquaculture drugs:
- IA #16-124: Detention Without Physical Examination of Aquaculture Seafood Products due to Unapproved Drugs;
- IA # 16-127: Detention Without Physical Examination of Crabmeat Due to Chloramphenicol;
- IA #16-129: Detention Without Physical Examination of Seafood Products Due to Nitrofurans;
- IA #16-131: Detention Without Physical Examination of Aquacultured Catfish, Basa (Pangasius sp), Shrimp, Dace, and Eel Products from the People's Republic of China (PRC) Due to the Presence of New Animal Drugs and/or Unsafe Food Additives.
Presently, 41 firms from seven countries are subject to DWPE due to unapproved drug residues. There is one country-wide DWPE for unapproved drug residues for certain aquaculture products imported from the People's Republic of China (PRC.
Testing of imported aquacultured species over the past 4 years revealed that products imported from Asia (mainly the PRC, Vietnam, and Indonesia) and South American countries have been the primary sources of origin of violative product.
|Country||No. of violative samples (No. of samples analyzed from the country)|
|FY07||FY 06||FY 05||FY 04|
|Vietnam||4 (46)||8 (52)||20 (84)||11 (55)|
|PRC||40 (303)||48 (214)||2 (44)||6 (91)|
|Indonesia||3 (46)||5 (48)||5 (73)||5 (63)|
|Total No. of imported aquaculture seafood samples collected for drug residue testing from all countries||647||463||364||241|
A summary of the results from the Chemotherapeutics in Seafood programs from Fiscal Years 2004 to 2007 follows:
|FY||No. of countries associated with samples collected||Number of samples collected||Number of analyses||Number of violative samples||Number of violative samples by drug and product|
|2004||16||622||702||28||Chloramphenicol: Shrimp-6, Crab-22|
|2005||21||536||587||28||Chloramphenicol: Shrimp-3, Crab-10
Malachite Green: Basa-2, Eel-1
|2006||20||588||647||71||Chloramphenicol: Shrimp-2, Crab-7
Fluoroquinolones: Basa-2, Grouper-1, Tilapia-1
Malachite Green: Basa/Catfish-15, Eel-29, Grouper-3, Tilapia-3, Dace-1
Malachite Green: Basa/Catfish-12, Eel-8, Tilapia-2, Dace-2, Salmon-1
Crystal (Gentian) Violet: Catfish-2, Shrimp-1
Note: Differences between the number of samples collected and the number of analyses are due to: a sample may be collected and analyzed in 2 different fiscal years, multiple analyses may be conducted on a single sample, and on rare occasions, analysis is not conducted on a sample collected.
Collection and testing of 1100 import and domestic aquaculture drug samples is planned in FY 2008 with products from Vietnam, Bangladesh, PRC, Indonesia, India, Chile, and Taiwan continuing to be identified as a first priority.
The public health control procedures established for molluscan shellfish are dependent upon the cooperative efforts of state regulatory agencies, the shellfish industry, and FDA. These form the tripartite cooperative control program known as the National Shellfish Sanitation Program (NSSP).
Each partner in this program has responsibility for specific aspects of the Program. Responsibilities include the following:
Each shellfish producing state adopts adequate laws and regulations for the sanitary control of the shellfish industry, conducts sanitary surveys of growing areas, patrols restricted and prohibited areas, inspects shellfish processing plants, and performs such additional inspections, laboratory investigations, and control measures as are necessary to ensure that the shellfish reaching the consumer have been grown, harvested, and processed in a sanitary manner. The states annually issue certificates to shellfish dealers who comply with agreed upon sanitary standards. Copies of these certificates are forwarded to FDA.
FDA conducts an annual review of each state's shellfish control program, including the inspection of a representative number of growing areas and shellfish processing plants. On the basis of the information obtained, FDA determines the degree of conformity the state control program has with the requirements of the NSSP. Additionally, FDA publishes a monthly list of valid interstate shellfish shipper certificates for the information and use of food control officials, the seafood industry, and other interested persons.
The shellfish industry participates in the NSSP by obtaining shellfish from safe sources, providing processing plants that meet agreed upon sanitary standards, implementing HACCP principles, maintaining sanitary operating conditions in their processing plants, placing the proper certification number on each shellfish container, and keeping and making available to control authorities records showing the origin and disposition of all shellfish they handle.
FDA's Molluscan Shellfish Compliance Program, 7318.004, covers the evaluation of state and of foreign country shellfish programs with which FDA has established a Memorandum of Understanding (MOU). The objective of this Compliance Program is to evaluate the activities of participating state and MOU-country control agencies using a risk-based approach. The Compliance Program focuses on three specific state program elements: growing area classification, processing plants and shipping, and control of illegal harvest.
The growing area classification and control of illegal harvest elements of the regulatory program are evaluated at a frequency determined by a risk rating. Risk ratings are determined based on identified risk factors that are assigned a specific level of risk based on a defined point rating system. Total points assigned for each risk factor determine the frequency of evaluation for the growing area classification element. States whose total point scores indicate an overall low risk are evaluated once every 2 years. States found to have a score indicating an overall high risk are evaluated every year. However, states that have a historical propensity for illness outbreaks are evaluated every year regardless of the overall risk rating score. The number of growing areas selected for evaluation is randomly chosen from the list of all the growing areas in the state and based upon a representative sample designed to provide a 95 percent probability of detecting a 20 percent or greater non-compliance level. Evaluations entail file reviews and field observations.
The processing plant and shipping element is evaluated once every 2 years. However, states that have developed an action plan under the NSSP to correct deficiencies or that have unresolved nonconformities are also reevaluated during the intervening year. The processing plant and shipping element is evaluated against a set of specifically defined criteria, and the overall compliance status of the state for this element is determined according to standards developed for evaluating the state inspection program. Processing plants are selected randomly for evaluation from those listed in the Interstate Certified Shellfish Shippers List. The number selected for evaluation is based on a representative sample designed to provide a 95 percent probability of determining a 20 percent or greater non-compliance level. Evaluations entail file reviews and processing plant site visits.
The control of the illegal harvest element is evaluated based on a risk rating derived from the state's growing area patrol frequency. States determined to be in the high risk category for this program element are evaluated yearly. States considered to be in the low risk category are evaluated every 2 years. Patrol areas are selected randomly for evaluation from a list of all patrol areas in the state. The number selected for evaluation is based on a representative sample designed to provide a 95 percent probability of determining a 20 percent or greater non-compliance level. Evaluations entail file reviews and field observations of selected patrol areas.
In addition to these elements, FDA also evaluates and monitors laboratories that provide microbiological and marine biotoxin analytical support to state shellfish control programs to ensure that they are capable of providing the high quality data necessary for public health protection. Laboratory evaluations are conducted on a 3 year cycle and include a demonstration of essential analytical skills, as well as a critical review of quality assurance plans, standard operating procedures, key operational records, and documented maintenance and performance checks.
III. Section 2: Describe the feasibility of developing a traceability system for all catfish and seafood products, both domestic and imported, for the purpose of identifying the processing plant of origin of such products.
A. Seafood Traceability - General
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act) provides a partial traceability framework for domestic seafood. FDA considers "domestic seafood" to include seafood that originated in the U.S. as well as seafood currently in domestic commerce that was imported. The Registration of Food Facilities provision in the BT Act (§ 415 of the FDCA) and FDA's implementing regulations at 21 CFR Part 1, Subpart H, require all domestic and foreign facilities that manufacture, process, pack, or hold food that will be consumed in the U.S. to register with the FDA; the registration must include the names, addresses, and phone contact information for the facility, its parent company (if applicable), and owner, operator, and agent in charge. The Maintenance and Inspection of Records provision in the BT Act (§ 414 of the FDCA) and FDA's implementing regulations at 21 CFR Part 1, Subpart J, require persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records that identify the immediate previous sources and immediate subsequent recipients of all food received and released. The BT Act expressly exempts farms, which may include aquaculture facilities, from both the registration and recordkeeping requirements. Moreover, all foreign persons, except those who transport food in the U.S., are exempt from all recordkeeping requirements.
Generally, any person who manufactures, processes, packs, holds, transports, receives, imports, or distributes food, including seafood, in the U.S. is required to establish and maintain records that identify the immediate previous source of the food and immediate subsequent recipient of the food. A processor must also identify the transporters who delivered the food to and away from that processor. Processors' records must also include information reasonably available to identify the specific source of each ingredient used to make every lot of finished product. Such information as the amount of food received, date of receipt, and lot codes of that food, if they exist, are generally also required in these records. In addition, U.S. food transporters are required to establish and maintain records that identify the immediate previous source from which they received the food and the immediate subsequent recipient to whom they release the food.
Non-processing aquaculture farms or fishing vessels are exempt from the registration and recordkeeping requirements of the BT Act. Retail facilities that sell directly to consumers are exempt from registration; however, such facilities that have more than 10 full-time equivalent employees (FTE) must establish and maintain records of all food they receive, but do not have to establish and maintain records of food released to consumers.
The BT Act requirements related to imported food do not provide the same level of traceback when several sequential processors are involved. A foreign processing facility that delivers food to another foreign processor is not required to register with the FDA. All foreign persons are exempt from the BT Act recordkeeping requirements, except the foreign persons that transport food within the U.S.
As part of its efforts to combat terrorism and to protect consumers from imported food that has been deliberately or accidentally contaminated, Congress included Prior Notice requirements in the BT Act (Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) as amended). Prior Notice requires that the agency be given notice before an imported food arrives at a U.S. port. Some of the information to be provided through Prior Notice includes:
- The country of production;
- The country from which the food is shipped;
- The identity of the shipper, importer, owner, and consignee;
- The foreign manufacturer if the food is processed; and
- The grower, if known, or growers' consolidator, if the food is in its natural raw state (fresh, frozen, headed, or gutted fish).
This information can facilitate tracebacks if the seafood product is not handled by a number of foreign processors, which is usually the case with raw products or those undergoing very little processing. However, if a seafood product is progressively held or processed by multiple processors, these regulations do not allow traceback through foreign processing supply channels.
The Seafood HACCP Regulation provides a potential mechanism to traceback imported seafood to processors preceding the registered foreign processor. The regulation, in part, requires U.S. importers to implement procedures to ensure that fish or fishery products offered for import are processed in accordance with the Seafood HACCP Regulation, unless they are importing from a country with which FDA has a MOU as provided for in 21 CFR 123.12(a)(1), which currently exists only for molluscan shellfish. If an importer obtains copies of HACCP plans from its immediate suppliers and the processors earlier in the supply chain, as a means of meeting its regulatory obligation, the processor would be able to trace its products back all the way to the processor that received the product from the fisherman or aquaculture producer.
The initial stages of traceback during an illness follow-up may be the most challenging. Initially identifying a suspect food can be delayed if the victim has died or is otherwise inaccessible to be interviewed regarding foods recently consumed. Tracebacks beginning with the consuming public may also be difficult because, for practical reasons, the BT Act does not require retailers to record when and to whom they sell specific lots of seafood. Therefore, in the absence of a labeled retail package, there may be no positive traceability connecting the consumer with a particular lot of food sold by the retailer or to the last processor or manufacturer. In addition, retail outlets with fewer than 10 FTEs and restaurants are not required by the BT Act to maintain records of their sources of food. Consequently, information may not be readily available to rapidly begin tracing back to the most recent processor without a label that identifies the manufacturer.
Seafood processors are not required to use production codes to identify the lots of product they produce; however, if such lot codes exist, the processors must include them in the records they are required to establish and maintain under the BT Act. The exception is for low acid canned foods (LACF), acidified foods, and infant formula (naturally, the latter does not affect seafood), which are required to include production codes on the product. For infant formula, FDA has a specific statutory provision (21 U.S.C. § 350a), which gives it authority to establish regulations to describe manufacturing conditions, record keeping requirements, and recall provisions. As part of that authority, FDA has established lot code requirements. For LACF and acidified foods, FDA has established lot code requirements as implemented by the authority under the emergency permit control provision (21 U.S.C. § 344). Under this section, FDA established regulations that require manufacturing controls for foods that are of a nature that consumers would not be able to tell they may be microbiologically contaminated.
When there is a need to identify or focus on a particular production period or lot due to an adverse reaction or illness, such codes are important and can significantly hasten the traceback effort. The seafood industry often includes production coding on its products and maintains records associated with the coding for its own tracking and inventory purposes. These records become accessible and can be helpful to FDA during a traceback emergency (21 U.S.C. § 350c). Proper coding of product may also prevent a processor from recalling or destroying huge amounts of production or all available product because it is unknown which product was affected following an illness.
B. Traceability of Molluscan Shellfish
The NSSP system may provide a model design for a system of product traceability throughout the production and distribution chain. The NSSP requires that shellfish product be identified with certain information demonstrating that it was harvested by licensed harvesters and shipped and processed by certified dealers. This information assists in tracing the product back through the distribution system to the growing area in the event that the shellfish are implicated in a disease outbreak.
In the case of an outbreak of disease attributed to shellfish, it is necessary that appropriate state and federal agencies be able to determine the source of the contamination and prevent further outbreaks from this source. This can be done most effectively by following the course of a shipment through all the various dealers who have handled it and back to the point of origin by means of the records kept by the shellfish dealers.
In order to achieve and maintain traceability of molluscan shellfish from harvest through distribution, and to the consumer, the NSSP requires a system of harvester and dealer tagging. Tags must be durable, waterproof, and approved by the state shellfish control authority prior to use. Tags must also be a specific size (13.8 square inches/89.03 square centimeters), legibly written in indelible ink, and contain the specific information designed to provide a detailed history of the product from harvest to dealer through subsequent processing and shipment. This information permits traceability back to the source of the shellfish from any point along the distribution chain.
Harvester tags must contain the following information:
- The harvester's identification number assigned by the state shellfish control authority;
- The date of harvesting;
- The most precise identification of the harvest location or aquaculture site possible. This must include the state from which the shellfish were harvested and the designated growing area within that state; and
- Type and quantity of shellfish.
The harvester tags must be attached to each container of harvested shellfish to maintain the lot identity. The tags are required to remain attached to the container until it is emptied or retagged by the dealer who must thereafter keep these tags on file for 90 days for the purpose of establishing traceability.
Dealer tagging is also required at the time of harvest if the harvester is also a dealer. Otherwise, dealer tagging is required upon receipt of the shellfish from a harvester, or when the shellfish are processed or packaged by the dealer, or when the shellfish are sold to other dealers for subsequent sale, processing, or additional packaging. Dealer tags are attached to each container of shellfish handled in order to maintain the lot identity. The dealer tags must contain the following information:
- The dealer's name, address, and certification number assigned by the state shellfish control authority;
- The original or previous shellfish shipper's certification number;
- The date of harvesting;
- The most precise identification of the harvest location or aquaculture site possible. This must include the state from which the shellfish were harvested and the designated growing area within that state; and
- The type and quantity of shellfish.
The dealer tag must be attached to the container until it is empty or retagged by another dealer subsequently handling the product. These tags must be kept on file for 90 days for the purpose of maintaining traceability.
Shellfish destined to undergo further or additional processing must be kept and processed separately to prevent commingling of lots and misidentification in the event of a disease outbreak. Lot identity for processing is provided through the use of the harvester or dealer tags and subsequently maintained after processing by the dealer tag, which is attached by the processor to all containers prior to shipment to another dealer or retailer. Again, the harvester or previous dealer's tag must be kept on file for 90 days to document the history of the product and maintain its traceability.
This process of dealer handling and further processing, retaining previous tags, and retagging is repeated until the shellfish finally reaches the consumer. The shellfish tagging system is designed to document this journey of the shellfish from harvest to consumer. Each dealer, as well as the harvester, and ultimately the source of the shellfish, can be identified from the series of tags that are generated and retained as the shellfish progress from harvest to the consumer, and provides traceability from harvest through distribution, and to the consumer.
IV. Section 3: Provide for an assessment of the risks associated with particular contaminants and banned substances.
A. Risks of Seafood Contaminants - General
Many undesirable organisms, substances, or objects may be introduced into seafood products as a consequence of the environment in which they once lived or due to accidental exposures over the course of handling and processing during harvest, manufacture, transport, and storage. To prioritize use of its resources, FDA distinguishes between products presenting higher and lower risk based on the general information available to the agency that the product, its form, its production, its handling, its intended manner of consumption (e.g., raw or cooked), or its sources, have the propensity to expose consumers to hazards. While few identified hazards undergo a formal, resource-intensive risk analysis or risk assessment, FDA uses its scientific knowledge and regulatory experience and considers information available to the scientific community at large to discern which hazards may present greater risks. The agency's emphasis changes as new information related to the products or their hazards becomes available.
Some of the products that FDA currently considers high priority for sampling and surveillance activities, as determined by relative likelihood and severity of potential food safety concerns, include:
- Refrigerated reduced oxygen packaged products;
- Molluscan shellfish products from uncertified sources;
- Ready-to-eat seafood;
- Seafood mixes containing combinations of raw, partially-cooked, and cooked seafood components;
- Scombrotoxin (histamine)-forming fish;
- Aquacultured seafood; and
- Salt-cured and/or dried uneviscerated finfish.
With an awareness of the potential for contamination, the likely sources of contamination, and the implementation of controls to prevent contamination, processors can reduce the probability of contamination occurring in the seafood products and can, therefore, minimize exposure of consumers to hazards.
In 1997, the FDA implemented the Seafood HACCP Regulation that significantly advanced consumer protections from seafood contaminants by requiring processor measures to prevent the introduction of contaminants into the seafood they process or that they transport through commerce.
HACCP, similar to many other successful manufacturing programs such as Statistical Process Controls and FDA's LACF and Acidified Foods programs, obligates the processor to routinely monitor its manufacturing operations to ensure that they are within established control parameters so that the processor can be confident that the end product meets the programs specifications and is safe. In over 10 years since the Seafood HACCP Regulation went into effect, FDA has seen many domestic processors evolve from having a lack of understanding or awareness of the hazards associated with the products they produced to make adjustments in their HACCP plans to ensure that they optimize production while maintaining appropriate preventative controls.
The regulatory advantage of proper application of HACCP principles is that the records generated permit FDA and other competent authorities, including management of the manufacturers themselves, to review the daily operations of the processor for days, weeks, months, or years preceding the actual day of inspection to assess the safety and compliance of the operations. Inspectors are no longer left with only a small sampling of a manufacturing operation based on the activities observed in the few hours or days of a periodic inspection. The written HACCP plan tells the investigator much about a processor's recognition of the hazards associated with its products and processes and the processor's understanding of the activities necessary to control and prevent those hazards from occurring. The monitoring records tell the investigator if appropriate actions have been undertaken with every lot produced. These plans and records are revealing prior to, or in absence of, an actual on-site inspection, which can be extremely advantageous in assessing less accessible foreign processing operations.
B. Risks of Banned Substances (New Animal (Aquaculture) Drugs)
Section 1006 of FDAAA addresses Congressional findings and concerns specifically related to the increase in aquaculture and the findings of non-approved substances in seafood, focusing specifically on the issue of unapproved new animal (aquaculture) drugs.
Aquaculture, both domestically and internationally, poses unique production problems not encountered in capture (wild-caught) fisheries. Aquaculture producers rely on chemicals and new animal drugs to overcome issues associated with high density farming and poor on-farm hygiene. A wide range of chemicals is used to control or prevent specific diseases, to improve water quality conditions, and to manage pest (e.g., weed) or stress problems.1In the U.S., all chemical compounds to be administered as new animal drugs in food-producing animals are required to be the subject of an approved new animal drug application under Section 512 of the FFDCA. FDA approves new animal drugs for a specific species, condition of use, route of administration, dosage regimen, and withdrawal time. Tolerances may be established for residues of new animal drugs in edible products of food-producing animals treated with approved drugs.
Relatively few new animal drugs have been approved for aquaculture in the U.S. As a result, aquaculture growers, particularly in developing countries, may use unapproved new animal drugs or general purpose chemicals that are not permitted for drug use in an attempt to prevent or control fungal, viral, or bacterial problems.1
There is clear scientific evidence that the application of these compounds during the various stages of aquaculture can result in the presence of the drugs or their metabolites in the edible portion of the aquaculture products.2 The potential immediate and long-range human health consequences may include hypersensitivity reactions, toxicity-related reactions, potential carcinogenic and mutagenic effects, and increasing prevalence of antibiotic-resistant microorganisms.3 Some of the unapproved antibiotics used in farmed fish are important agents in treating human diseases, such as ciprofloxacin, erythromycin, and tetracyclines.4,5
In recent years, residues of chloramphenicol, nitrofurans, malachite green, gentian (crystal) violet, and fluoroquinolones have repeatedly been found in imported seafood products.2 These chemotherapeutic agents are not approved in the U.S. Processors of products in which these chemotherapeutic agents are found may be placed on Import Alert. For example, in August of 2007 five aquacultured species from firms in China were placed on country-wide Import Alert for DWPE.
Chloramphenicol is a broad-spectrum antibiotic that is not approved for use in food-producing animals and is prohibited from extra-label uses in food-producing animals (21 CFR 530.41(a)(1)). According to a World Health Organization (WHO) toxicology analysis, the drug has been implicated in cases of serious and potentially fatal blood disorders, such as idiosyncratic aplastic anemia; this adverse reaction is not dose related. A safe level of exposure to chloramphenicol has not been determined. Chloramphenicol is suspected to be a carcinogen and may potentially affect the reproductive system in humans.6
Nitrofurans are a broad-spectrum class of antibiotics, which can be used to combat bacterial infections in humans and animals. Use of nitrofurans in any life stage of an animal would result in residues in the end product because nitrofurans are rapidly metabolized and bind to cellular macromolecules. The tissue-bound residues of nitrofurans are very stable and do not degrade to a significant extent as a result of common food preparation techniques, such as cooking, baking, grilling, or microwaving. Studies have shown that residues of nitrofurans ingested by consuming contaminated product are bioavailable, forming tissue-bound residues in the consumer's body. The drug is considered to be carcinogenic and genotoxic.7
Reports issued by the National Toxicology Program on nitrofurans concluded that, under the conditions of 2 year feeding studies, there was clear evidence of carcinogenic activity of these compounds in mice and rats.8,9,10
In 1991, FDA withdrew the approvals of two nitrofuran drugs, nitrofuranzone and furazolidone (56 FR 41902 August 23, 1991). These two drugs had several approved new animal drug applications for both poultry and swine. It was determined that this class of compounds could induce cancer in humans and animals. In February 2002, FDA issued an order prohibiting the extra-label use of topical nitrofuran drugs in food-producing animals based on information regarding carcinogenicity and evidence that use will likely result in the presence of residues in the animal tissue (67 FR 5470 Feb 6, 2002).
There are very few approved animal uses of nitrofurans in the U.S. The approved products are for topical dosage forms for non-food producing animals (i.e., cats, dogs, and horses). Nitrofurans are on the list of drugs prohibited from extra-label use in any food animals, including seafood [Title 21 Code of Federal Regulations part 530.41(a)(7) and (a)(8)].
Malachite green (MG), a triphenylmethane dye, has been applied extensively to fish worldwide in aquaculture operations. It has been administered as a therapeutic agent against common external parasites, as well as used for some skin and gill diseases. MG is environmentally persistent and is toxic to a wide range of aquatic and terrestrial animals. MG undergoes a conversion to the reduced leuco form in fish tissue when absorbed through the skin. A metabolite, leucomalachite green (LMG), accumulates in the muscle tissue of exposed fish for a relatively long time with a half-life of about 40 days.11,12
MG has generated much concern regarding its use due to the potential hazard. The application of MG to farmed fish in any life stage could result in residues in the final product. MG is considered potentially mutagenic and carcinogenic. The 2004 National Toxicology Program (NTP) study and several other studies have shown that MG and its metabolite LMG are multi-organ toxins. The toxicity of the compound increases with increased time and concentration of exposure.13,14,15 Currently, MG is used in the U.S. as a parasiticide only in ornamental/aquarium fish. It is not approved for any food-producing animals. MG is prohibited for application in fish by several countries including Canada and the European Union. However, this chemical is still being used in many parts of the world as a very effective and inexpensive therapeutic agent.
Gentian violet (GV), also known as crystal violet, is a triphenylmethane dye, similar to MG. It has been used in the aquaculture industry for treatment and/or prevention of external fungal and parasitic infections in fish and fish eggs. GV is readily absorbed into fish tissue from water exposure and is reduced metabolically by fish to the leuco moiety, leucogentian violet (LGV). LGV accumulates in the muscle tissue and is eliminated very slowly.16 Several studies report the carcinogenic and mutagenic effects of crystal violet in rodents. It has also been linked to human bladder cancer. The leuco form induces renal, hepatic, and lung tumors in mice.17,18
The FDA has never approved any product containing GV for use in animal feed. In the past, FDA has stated that the compound is not generally recognized as safe (GRAS) for use in animal feed and would require an approval as a food additive or a new animal drug application before marketing for animal use (21 CFR 500.29, 21 CFR 500.30 and 21 CFR 589.1000).
Fluoroquinolones represent a critically important class of synthetic antibiotics, bacterial gyrase inhibitors, used to treat serious infectious in humans. Both FDA and WHO ranked fluoroquinolones as essential antimicrobial agents for human health and animal health and welfare. However, non-human uses of fluoroquinolones have been of concern for a long time.
FDA prohibited the extra-label use of fluoroquinolones in food-producing animals in 1997 [62 Federal Register 27944]. This decision was based on evidence that widespread application of fluoroquinolones in food animals would promote the evolution of drug-resistant pathogens that could be transmitted to humans via the food chain, and that resistant pathogens will likely be present at slaughter. Consequently, the ability to treat human diseases with these antimicrobial drugs may have been compromised. There are concerns about a range of deleterious effects that antimicrobial resistant bacteria may have on human health including increased duration of illness, treatment failure, and loss of therapeutic options.5
Fluoroquinolones have never been approved for use in any aquatic species in the U.S. and such use is considered to be unsafe.
The enrofloxacin approval for use in poultry was withdrawn in September 2005 (Final Decision of the Commissioner; Docket No. 2000N-1571). Presently, there are two approved fluoroquinolones for food animals, danofloxacin and enrofloxacin, which are only allowed to be used in beef cattle and only by injection.
Fluoroquinolones are currently listed as drugs prohibited for extra-label use in food-producing animals [Title 21 Code of Federal Regulations 530.41(a)(10)].
- 1 Graslund S., K. Holmstrom, and A. Wahlstrom. A field survey of chemicals and biological products used in shrimp farming. Marine Poll. Bull. 46: 81-90, 2003.
- 2 FDA Seafood Import Sample Data.
- 3 American Society for Microbiology (ASM) Task Force Report on Antibiotic Resistance, ASM, 1994, http://www.asm.org/?option=com_content&view=article&id=5961.
- 4 US FDA CVM Guidance to Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern, October 2003.
- 5 World Health Organization, Food and Agriculture Organization of the United Nations, and the World Organization for Animal Health. 2003. Joint FAO/OIE/WHO Expert Workshop on Non-Human Antimicrobial Usage and Antimicrobial Resistance, Geneva. http://who.int/foodsafety/publications/micro/en/amr.pdf.
- 6 Toxicology Evaluation of Certain Veterinary Drug Residues in Food; WHO Food Additives Series: 33, 1995 and WHO Food Additives Series: 53, 2004.
- 7 WHO Technical Report Series 832: Evaluation of Certain Veterinary Drug Residues in Food, Fortieth Report of the Joint FAO/WHO Expert Committee on Food Additives, 1993.
- 8 Toxicology and Carcinogenesis Studies of Nitrofurazone; National Toxicology Program; Technical Report Series No. 337, June 1988.
- 9 Toxicology and Carcinogenesis Studies of Nitrofurantoin; National Toxicology Program, Technical Report Series No. 341, September 1989.
- 10 Toxicological Evaluation of Certain Veterinary Drug Residues in Food, 40th JECFA meeting, WHO Food Additives Series No. 31, 1993.
- 11 S. M. Plakas, K. R. El Said, G. R. Stehly, W. H. Gingerich, and J. L. Allen, Uptake, tissue distribution, and metabolism of malachite green in the channel catfish (Ictalurus punctatus) (1996) Can J. Fish. Aquat. Sci. 53, 1427-1433.
- 12 S. J. Culp, and F. A. Beland, Malachite green: a toxicological review. J. Am. Coll. Toxicol. 15, 219-238, 1996.
- 13 NTP Technical Report on the Toxicity Studies of Malachite Green Chloride and Leucomalachite Green; National Toxicology Program Technical Report Series: 71, June 2004.
- 14 Toxicology and Carcinogenesis Studies of Malachite Green Chloride and Leucomalachite Green; National Toxicology Program Technical Report Series: 527, February 2005.
- 15 S. Srivastava, R.Sinha, and D. Roy. Review Toxicological effects of malachite green; Aquatic Toxicology 66, 2004.
- 16 H. Thompson Jr., L. Rushing, T. Gehring, and R. Lockmannn. Persistence of gentian violet in channel catfish muscle after water-borne exposure; Journal of Chromatography 723, 1999.
- 17 Teratologic Evaluation of Gentian Violet in CD Rats; National Toxicology Program Study: TER 82079, 1982.
- 18 R. Docampo, and S. Moreno: The metabolism and mode of action of gentian violet; Drug Metabolism Reviews: 22, 1990.
[a] For purposes of this Report to Congress, the term "hazard" should be taken in the context of a "food safety hazard," which is defined in the Seafood HACCP Regulation as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." (see 21 CFR 123.3(f))
[b] The number of establishments and inspections reported do not include molluscan shellfish operations that do no further processing of the shellfish; evaluations of these operations are conducted differently (see Molluscan Shellfish Inspections).