• Final: Assessment of the Potential Change in Human Health Risk associated with Applying Inspection to Fish of the order Siluriformes
• Draft: Risk Assessment of the Potential Human Health Effect of Applying Continuous Inspection to Catfish 
  • Peer Review Comments and Responses 
• Final Rule: Mandatory Inspection of Fish of the Order Siluriformes and Products Derived From Such Fish
• Fish Cost Estimate
• Siluriformes Self-Reporting Tool (SRT)
  This is a model questionnaire that explains how a country should categorize its food safety inspection system associated with fish of the order Siluriformes and respond to the SRT.

Code of Federal Regulations (CFR)

• Subchapter F Parts 530-561- Mandatory Inspection of Fish of the Order Siluriformes and Products of Such Fish

How do I apply for federal inspection?

Learn how to apply for a grant of inspection.

Can an official meat or poultry establishment update its Grant of Federal Inspection to include Siluriformes fish?

Yes. The establishment would need to submit an updated FSIS Form 5200-2 to their District Office.

Do “box-in, box-out” distribution facilities currently registered with FSIS need to amend their registration to include Siluriformes fish?

Yes, these facilities will need to submit an updated FSIS Form 5020-1 to the Office of Investigation, Enforcement and Audit. The completed form should be submitted to the address at the top of the form and also here:

USDA, FSIS, OIEA, ELD,
1400 Independence Ave. SW
Stop Code 3753, PP3, Cubicle 8-235A
Washington, D.C., 20250-3700

What fish are now under FSIS jurisdiction?

As of March 1, 2016, FSIS has jurisdiction over all wild-caught and farm-raised Siluriformes fish that are harvested and sold for human food in the United States. This includes Siluriformes fish and fish products that are imported into the United States.

The following chart* lists some of the Siluriformes fish most commonly marketed in the United States.  Please note that this list is not all-inclusive.  Because common names of the fish can vary, reference the scientific name to determine whether the product is in the order Siluriformes.

Are “roe” (eggs) and “maw” (air bladders) from Siluriformes fish subject to the final rule?

Yes, the requirements in the final rule apply to the production of Siluriformes fish parts other than the skeletal muscle (including “roe” and “maw”) to be sold for human food.

What activities require FSIS inspection?

Generally, under the Federal Meat Inspection Act (FMIA) and its implementing regulations, any establishment preparing Siluriformes fish or fish products for the wholesale market is required to operate under FSIS inspection. Retail businesses that prepare fish and fish products for sale to the end consumer are exempt from the requirements for inspection. 

For a product with multiple ingredients, what amount of Siluriformes fish in the product would make it a product that falls under FSIS jurisdiction?

Generally, a product with multiple ingredients falls under FSIS jurisdiction and subject to its inspection if the product contains at least 3 percent raw or at least 2 percent cooked Siluriformes fish and is not otherwise exempt from inspection (see 9 CFR § 532.5 and 532.3, respectively).

FSIS verifies that amenable product, which includes Siluriformes fish and Siluriformes products, in U.S. commerce (outside of the federally inspected facility) are wholesome, are not adulterated, and are properly marked, labeled, and packaged. Such in-commerce locations include where amenable products are stored, held, transported, sold, offered for sale or transportation, imported, or exported. As necessary, FSIS will investigate apparent violations, food safety incidents, or other allegations or incidents involving Siluriformes fish or Siluriformes fish products. Such violations include producing Siluriformes fish products without the benefit of FSIS inspection.

When violations of the FMIA or regulations are alleged or detected, FSIS program employees control or detain adulterated, misbranded, or other violative products in commerce; investigate allegations, violations, or food safety incidents; collect, maintain, and secure evidence; and document investigative reports to support Agency decisions, investigative findings, and enforcement or legal actions. FSIS has the legal authority to take criminal, civil, or administrative enforcement actions against firms and individuals for violations of the FMIA or regulations.

• FSIS’ Office of Office of Investigation, Enforcement and Audit (OIEA) reviews all applications for grants of inspection to determine if responsibly connected individuals have prior felony or multiple misdemeanor convictions (which may make them ineligible for a grant).
• During the 18-month transitional period that ends September 1, 2017, FSIS’ Office of Field Operations and OIEA Investigators will:
  • Conduct educational outreach at firms and facilities that store or transport Siluriformes fish or fish products as part of their in-commerce surveillance activities;
  • Give Siluriformes fish entities the opportunity to bring their operations into full compliance with the new regulations;
  • Enforce adulteration and species labeling in commerce, including if from an inspected source;
  • Will investigate and document violations.

By the end of the 18-month transitional period, farms and transporters that supply fish to official establishments must register with FSIS using FSIS Form 5020-1, Registration of Meat and Poultry Handlers (9 CFR 550.5).

• Besides those farms and transporters, other handlers of Siluriformes fish and fish products (domestic broker, public warehouseman, import broker, wholesaler, renderer, and animal food manufacturer) also need to register.
• Anyone already registered that also handles Siluriformes fish and fish products must reregister to include that product type.

FSIS must approve all labels used on products produced by official establishments when those products are distributed in commerce. FSIS approves labels either through the sketch approval process or through generic label approval.

• Establishments must obtain FSIS prior approval for labels of Siluriformes fish products before products may be marketed.
• On September 1, 2017, all labels requiring FSIS approval must have a label approval on file.
• Label approval is granted one of two ways:
   
  • Sketch approval by the Labeling and Program Delivery Staff (LPDS);
  • Generic approval by being in compliance with applicable regulations.
     
• Only certain types of labeling on Siluriformes fish products require submission for evaluation by  LPDS (9 CFR 541.7(g), 412.1):
   
  • labels for temporary approval  (e.g., change in product formula where ingredients listed are no longer in descending order of predominance);
  • labels for products for export with labeling deviations (e.g., nutrition facts panel in a format not permitted on domestic labels);
  • labels with special statements and claims (e.g., all natural” or “no antibiotics administered”).
     
• Many Siluriformes fish and fish products labels can be generically approved and do not need to be submitted to LPDS for pre-approval.
• Establishments should submit labels that need sketch approval by LPDS during the 18-month transitional period.

Generic Approval and Farm Raised
 

Does the “FSIS Compliance Guideline for Label Approval” released August 2017 apply to Siluriformes fish products?

Yes, with one exception. The special statements and claims listed in the guide as requiring sketch approval by FSIS apply to meat products including Siluriformes fish; however, the claim “farm-raised” on Siluriformes fish labels does not require sketch approval by FSIS. As explained in the preamble of the Siluriformes fish final rule, the statements “farm-raised” and “wild-caught” may both be approved generically when added to Siluriformes fish labels, provided that that they are truthful statements. 

Do Siluriformes fish product labels with “farm-raised” or “wild-caught” claims have to be submitted to FSIS for sketch approval?

No. As explained in the preamble to the Siluriformes fish final rule, the raising claims ‘‘farm-raised’’ or ‘‘wild-caught’’ do not require FSIS sketch approval under 9 CFR 412.1(c)(3) and 541.7(g). However, as is the case for any statement or claim on a label, whether or not FSIS sketch approval is required, the establishment must have support for the claim on file, and make it available to FSIS personnel upon request.

 Ice Glaze

If Siluriformes fish products are misted with water and then frozen or ice-glazed, may the labeled net weight include the weight of the mist or glaze?

No, the net weight should reflect the weight of the product without the mist or glaze.

When Siluriformes fish products are misted with water and then frozen or ice-glazed, must these processes be declared on the label?

No. FSIS has found that water misting and ice glazing Siluriformes fish is a common industry practice, and recognized as such by consumers. Therefore, FSIS is not stipulating that a statement that these products have been water-misted or ice-glazed appear on the label. Note that if the glaze contains a solution that includes flavoring ingredients, e.g., spices, then the product would no longer be considered ice-glazed and would need to bear an ingredients statement that includes any ingredients.

Breading

Does 9 CFR 319.880 (which limits the amount of batter and breading used as a coating for breaded meat products) apply to breaded Siluriformes fish products?

Yes. Siluriformes fish products labeled as “Breaded” are limited to 30% or less breading. Siluriformes fish products that contain more than 30% breading may not be labeled as “Breaded.” However, FSIS would permit these products to be labeled as a “fritter,” or with a reference to the characterizing ingredients of the breading in the product name. Please refer to the FSIS Food Standards and Labeling Policy Book entry for “Fritters” for additional information.

Added Solution

Do the requirements in 9 CFR 317.2(e)(2) apply to Siluriformes fish products containing added solution, regardless of the method of incorporating the solution (for example, marinating, basting, injection, vacuum tumbling)?

Yes. The requirements would apply to products where solution has been incorporated into raw Siluriformes fish through any method, for example, marinating, basting, injection, or vacuum tumbling. 

How is the percent solution pickup calculated? Does the establishment need to weigh the Siluriformes fish prior to being marinated or injected and then weigh it after to see how much was absorbed?

Determining the percent pick up involves weighing the raw Siluriformes fish before solution is added, weighing the raw Siluriformes fish after adding solution and then performing a calculation to determine the percent solution pick up. From 9 CFR 317.2(e)(2)(i): “The percentage of added solution (total weight of the solution ingredients divided by the weight of the raw Siluriformes fish without solution or any other added ingredients multiplied by 100).” For example, a formulation which includes 80% fish and 20% solution of water, salt and sodium phosphate would need to bear the solution statement “Contains 25% solution of water, salt and sodium phosphate” because 20 (weight of the solution) divided by 80 (weight of the fish without added ingredients) is 25.

These guidebooks contain current protocols for analytical tests required by FSIS regulatory activities on meat, poultry and egg products.

• FSIS Analytical Chemistry Laboratory Guidebook
  The Guidebook contains methods for the analysis of food composition, food additives, nutrients, and veterinary drug and pesticide residues. Siluriformes relevant method numbers: R 45 - Veterinary drugs (MRM); R33d – Pesticides; R23c – Nitrofurans; R44a and R44b – Dyes; SO2 – Speciation; IO3 – Metals.
   
• FSIS Microbiology Laboratory Guidebook 
  Microbiological methods are presented for sample preparation, isolation and identification of the major foodborne pathogenic microorganisms and their toxins, meat tissue species identification, and the detection of extraneous materials and antimicrobial residues. Siluriformes relevant chapters: Chapter 4.08 – Salmonella; Chapter 8.09 – Listeria monocytogenes

Accessing FSIS Sampling Data
The Laboratory Information Management System –Direct (LIMS-Direct) is a web-based portal used to access sampling results. Results from FSIS testing is provided to FSIS field personnel, as well as to the email address for the plant found in the establishment's Public Health Information System (PHIS) profile.

• MOU 225-14-0009 - MOU between FSIS and FDA: Framework for cooperation between FDA and FSIS/USDA for regulation of Siluriformes fish and fish products re 2014 Farm Bill.
• MOU 225-12-0007 - MOU Between USDA and DHHS: Information sharing related to food safety, public health, and associated regulatory, marketing, and research activities
• MOU 225-99-2001 – MOU FSIS and FDA: To facilitate an exchange of information between the agencies about establishments and operations that are subject to the jurisdiction of both agencies

1.  Alabama
2.  District of Columbia
3.  Florida
4.  Illinois
5.  Iowa
6.  Kentucky
7.  Maryland
8. Michigan
9.  Nevada
10. North Carolina
11. South Carolina
12. Tennessee
13. Virginia

Food Defense is the protection of food products from intentional adulteration by biological, chemical, physical, or radiological agents. It addresses additional concerns including physical, personnel and operational security.

• Food Defense Guidelines for Siluriformes Fish Production and Processing
  These voluntary guidelines developed by FSIS are a compilation of best practices specifically developed to assist federally-inspected fish facilities.
• Food Defense Plan Security Measures for Food Defense for Siluriformes Fish Farmers and Processors
  Food defense plan developed to assist fish producers and processors in developing a food defense plan. 

FSIS has published an updated Product Categorization guide. Foreign exporters and governments can now find species that are now under FSIS jurisdiction (Siluriformes fish).

"In accordance with the FSIS rule published on December 2, 2015 (80 FR, 75590), the following countries have submitted documentation to FSIS showing that they have laws or other legal measures in place that provide the authority to regulate the growing and processing of Siluriformes fish for human food, and that will ensure compliance with the Food and Drug Administration's regulatory requirements in 21 CFR part 123, Fish and Fishery Products.  Files are provided in PDF format.

By the end of the 18-month transitional period, September 1, 2017, foreign countries seeking to continue exporting such products to the United States must submit adequate documentation showing the equivalence of their Siluriformes inspection systems with that of the United States. Starting August 2, 2017, imported Siluriformes fish and fish products from these countries must be presented for reinspection to FSIS."

When will foreign audits begin for equivalency determinations?

On-site verification audits of a foreign country’s Siluriformes fish inspection system will occur once FSIS has analyzed the foreign country’s responses to the Self-Reporting Tool (SRT) questions and supporting documentation and determined, based on the document review, that the country has an equivalent system. To continue exporting Siluriformes fish and fish products to the U.S., countries had to submit SRT responses and supporting documentation by September 1, 2017. FSIS will review the submission, and if the submission provides an initial basis for believing the country to be equivalent, FSIS will schedule an in-country audit.

What will be the scope of foreign audits?

Consistent with FSIS audit procedures, the scope of the audit will likely include government inspection offices, slaughter and processing establishments, cold storage facilities, and laboratories and may include farms.

Has the Self-Reporting Tool been modified for Siluriformes fish?

Yes. You can download a pdf of the Self-Reporting tool.

• Letter to Importers/Custom Brokers 
  Commercial shipments of Siluriformes fish and fish products certified after March 1, 2018 from Bangladesh, Canada, Dominican Republic, El Salvador, The Gambia, Guyana, Mexico, Myanmar, Nigeria, and Pakistan will no longer be eligible for importation into the United States.
• Letter to Importer/Customs Brokers
  FSIS will discontinue its interim Third-Party Hold-and-Test Protocol for shipments of Siluriformes fish and fish products. This action will be implemented December 18, 2017.
• Letter to Importers/Customs Brokers Regarding Reinspection of Imported Siluriformes Fish and Fish Products 
• FSIS published a letter to importers and brokers of Siluriformes fish products, and a list of official import inspection establishments that have updated their Grant of Inspection (GOI) to include Siluriformes fish and fish products. The list will be updated as additional establishments update their GOIs. These establishments can also be found on the FSIS Meat, Poultry, and Egg Product Inspection Directory page.
• FSIS published a letter to exporters of Siluriformes fish products providing guidance to these facilities,, informing them that starting September 1, 2017, FSIS would require all exported shipments of Siluriformes fish and fish products to be accompanied by a signed Siluriformes fish and fish products export certificate of wholesomeness, FSIS form 9060-5S. To request this certificate, a facility must be granted export certification services by their FSIS District Offices. Any additional requirements imposed by the country of destination are listed in the FSIS Export Library.

Are imported shipments of Siluriformes fish and fish products subject to FSIS reinspection?

Yes, all imported shipments of Siluriformes fish and fish products must be presented to FSIS for reinspection at an official import inspection establishment.

What exactly is needed for import paperwork?

The importer of record or broker will need to apply for FSIS reinspection using FSIS Form 9540-1. In addition, an original foreign inspection certificate must accompany every shipment of Siluriformes fish and fish products imported into the United States (see 9 CFR 557.4).

Can imported products be shipped to a processing establishment for the import reinspection?

No. Consistent with how FSIS handles other meat, poultry and egg product reinspection of imported product, FSIS will only reinspect shipments of imported Siluriformes fish and fish products at an official import inspection establishment.

 What is the process to become an official import inspection establishment?

Existing facilities that wish to be an official import inspection establishment for Siluriformes must contact their District Office to update their Grant of Inspection to include Siluriformes fish. New applicants should also contact their District Office.

Can official import inspection establishments expect to have the same inspectors for Siluriformes fish product as they do for meat and poultry products?

Yes, the same FSIS employees that conduct reinspection of meat, poultry, and egg products will also conduct reinspection of Siluriformes fish products.

What will the import inspection hours be for Siluriformes fish?

All questions regarding hours of inspection should be addressed with the official import inspection establishment. Hours of operation will be defined on the grant of inspection.

Will imported Siluriformes fish and fish products be sampled and tested as part of FSIS reinspection activities?

Yes. FSIS will periodically collect samples of raw imported Siluriformes fish and fish products during reinspection. The samples could be analyzed for chemical residues, Salmonella, or speciation.

Where does the above sampling take place?

Sampling during reinspection will occur at the official import inspection establishment.

What residues will FSIS test for in imported product and domestic?

When sampled, FSIS will test raw Siluriformes fish products for veterinary drug residues, including nitrofurans and some fluoroquinolones; malachite green; gentian violet; metals; and pesticides. A complete list of contaminants can be found within the appropriate residue method in our Chemistry Laboratory Guidebook.

Why does FSIS sample and test products?

FSIS samples and tests regulated products to verify compliance with the regulations and inform the effectiveness of Agency policy and procedures.

How long will it take to receive sample results (for imported and domestic product)?

For residue testing and speciation, it takes approximately seven days for a negative result and about 3 additional days to conduct more confirmatory tests if a sample screens positive. For Salmonella testing, negative results may be reported as soon as 2 days after sample receipt. Confirmation of a positive Salmonella result typically takes up to 7 days from sample receipt to report.

Who pays for the testing of samples collected by FSIS?

FSIS pays for the testing of samples it collects.

Are the labeling requirements for immediate containers different for imported products?

The required mandatory features for immediate container labels of imported product are consistent with the requirements for domestic product* and include the following:

*Siluriformes fish and fish products entering into the U.S. must bear labeling that meets the same FSIS labeling requirements as for domestic products, as applicable (see 9 CFR 541.7 for all labeling requirements).
** Labels for raw Siluriformes fish products containing added solution must include a descriptive designation (e.g., “contains 10% added solution of water, salt, phosphates……”)(9 CFR 317.2)(e)(2))

1. Name of product or descriptive designation of product;**
2. Ingredients statement, if the product is fabricated from two or more ingredients;
3. Foreign establishment number and inspection mark (canned products must comply with 9 CFR 327.14 (b) (2));
4. Handling statements, such as "Keep Frozen" or "Keep Refrigerated," if applicable;
5. Net quantity of contents, if applicable;
6. Name and address of manufacturer, packer or distributor;
7. Nutrition facts, unless an exemption applies;
8. Name of the country of origin, preceded by the words "Product of” placed immediately under the product name; and
9. Safe handling instructions for not-ready-to-eat (NRTE) products that have not undergone further processing that would render them ready-to-eat (RTE) and are destined for the consuming public.

If label deficiencies are found during reinspection of shipments of imported Siluriformes fish and fish products, will the importer of record or broker be allowed to correct the deficiencies?

Yes, consistent with existing policy, the importer of record will be provided with an opportunity to correct any label deficiency, except shipping marks, by stenciling or stamping or applying pressure sensitive stickers and obliterating the incorrect markings on all non-complying labels. Import inspection personnel will verify the correction before releasing the product into commerce.

What types of labels (for foreign and domestic product) need to be submitted to FSIS for approval prior to use?

1. The types of labels requiring submission to and approval by the FSIS Labeling and Program Delivery Staff are listed in 9 CFR 412.1(c)(1)-(4):
    
   1. Labels for temporary approval;
   2. Labels for products prepared under religious exemption (poultry only, not applicable to fish);
   3. Labels for products for export with deviations from FSIS domestic labeling requirements; and 
   4. Labels with special statements and claims. Please review the guidance for what constitutes a "special statement or claim." 
       
2. If a label does not fall into any of the above categories, it may be approved generically and need not be submitted to FSIS for prior approval. Such labels, however, must be in compliance with all other applicable labeling regulations.
   
   *As explained in the preamble of the Siluriformes fish final rule, the raising claims ‘‘farm-raised,’’ or ‘‘wild-caught’’ would not require FSIS sketch approval under 9 CFR 412.1(c)(3) and 541.7(g). However, as is the case for any statement or claim on a label, whether or not FSIS sketch approval is required, the establishment would need to have support for the claim on file and make such support available to FSIS personnel upon request.

What is the average time it takes for approval by the FSIS Labeling and Program Delivery Staff?

Sketch label approval turnaround is typically 7-10 business days for labels that need to be reviewed by FSIS. 
 

What is the best way to submit a label for approval?

The best way is by submitting a label application through the electronic Label Submission and Approval System (LSAS) system. 

Will pressure sensitive stickers be permitted on labels?

Yes, as an alternative to reprinting, for labels that are missing a required feature or contain inaccurate information, labels may be modified using pressure sensitive stickers. The pressure sensitive sticker must destroy the underlying label or package, if removed.

What information is required on shipping containers of imported products?

Required information on shipping containers includes product name, establishment number, handling statement (if product inside is perishable) and country of origin are required on all shipping containers containing immediate containers.

Will FSIS continue to accept FDA’s common or usual names for Siluriformes fish? 

Yes, the FDA-recognized common or usual name would be acceptable. For additional guidance on acceptable common or usual names, see Siluriformes Fish Species List and FDA’s Seafood List at https://www.accessdata.fda.gov/scripts/fdcc/?set=seafoodlist.

When does the importer of record need to submit the FSIS Form 9540-1, Import Inspection Application?

The importer of record or broker is required to provide the import inspection application (i.e., FSIS Form 9540-1) to FSIS at the official import inspection establishment no later than the time the entry is made with U.S. Customs.

How does FSIS define the terms importer or broker?

The importer, whether an entity or individual, is responsible for ensuring that legal goods are imported in accordance with U.S. law. Customs brokers are private individuals, partnerships, associations or corporations licensed, regulated and empowered by U.S. Customs and Border Protection (CBP) to assist importers and exporters in meeting Federal requirements governing imports and exports.