Consumer Safety Inspector Responsibilities at Fish Establishments
NOTE: DO NOT IMPLEMENT THIS DIRECTIVE UNTIL SEPTEMBER 1, 2017. CONSUMER SAFETY INSPECTORS ARE ALLOTTED 1 HOUR OFFICIAL TIME TO REVIEW THIS DIRECTIVE.
A. This directive instructs Consumer Safety Inspectors (CSIs) on how to verify regulatory compliance at official establishments that prepare (slaughter or process) fish of the order Siluriformes. This includes all establishments that prepare farm-raised or wild-caught fish. This directive instructs CSIs on how to perform inspection in such establishments, beginning on September 1, 2017, after the 18-Month transitional period.
B. In this directive, the term “fish” refers to fish of the order Siluriformes and products derived from these fish. For guidance on acceptable common or usual names, see Siluriformes Fish Species List.
- Fish are considered meat and are amenable to the Federal Meat Inspection Act
- Beginning September 1, 2017, CSIs assigned to establishments that prepare fish are to verify that establishments comply with all applicable regulatory requirements
- CSIs will perform inspection verifications on every shift at fish establishments; CSIs are not required to be present in establishments at all times.
- CSIs are to document regulatory noncompliance on noncompliance records, whenever they observe that fish establishments do not comply with applicable regulatory requirements
Specific instructions for sampling are described in FSIS Directive 14,010.1, Speciation, Residue and Salmonella Testing of Fish of the order Siluriformes from Domestic Establishments
FSIS Notice 24-17, Consumer Safety Inspectors Responsibilities at Fish (of the Order Siluriformes) Establishments during the 18-Month Transitional Period, 4/28/17
FSIS jurisdiction over fish started on March 1, 2016. (See Attachment 1 for final rule requirements.) FSIS provided an 18-month transitional period to give affected establishments the opportunity to bring their operations into full compliance with FSIS regulatory requirements. At the completion of the transitional period, September 1, 2017, establishments are required to fully comply with FSIS regulatory requirements. For example, fish establishments must have Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedures (SOPs), and Recall Plans by September 1, 2017, although establishments have 90 days after September 1, 2017, to validate their HACCP systems. All noncompliance is to be documented on noncompliance records.
IV. INSPECTION IN OFFICIAL ESTABLISHMENTS THAT SLAUGHTER OR PROCESS FISH
A. The CSI is to perform inspection verification tasks during each operational shift and any inspection activities requiring overtime inspection are to be conducted as set out in FSIS Directive 12,600.2, Reimbursable Overtime Inspection Services at Meat and Poultry Establishments.
B. The CSI is to follow the instructions in pertinent directives to perform inspection verification tasks. In general, the CSI is to perform, in the same manner for fish, the same inspection verification tasks that apply to meat (e.g., HACCP, Sanitation SOP, Sanitation Performance Standards, Hazard Analysis Verification, Economic/Wholesomeness). For example, the CSI is to follow the instructions in FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System, to verify HACCP, Sanitation SOPs, and Sanitation Performance Standards and FSIS Directive 7000.1, Verification of Non-Food Safety Consumer Protection Regulatory Requirements, to verify non-food safety consumer protection regulatory requirements.
NOTE: Attachment 2 is a list of Public Health Inspection System (PHIS) verification tasks and the associated fish regulations. Attachment 3 is a list of directives that apply to CSIs in fish establishments.
C. The CSI is to review the establishment profile to ensure the correct inspection tasks are listed in the establishment task list. This may include selecting tasks that were previously de-selected during the transitional period. FSIS Directives 5300.1, Managing the Establishment Profile in the Public Health Information System and 13,000.1, Scheduling In-Plant Inspection Tasks in the Public Health Information System (PHIS), provide instructions on how to view or edit the establishment task list in the PHIS profile.
D. When performing the Sanitation and HACCP verification tasks, the CSI is to document the specific regulations in 9 CFR Parts 416 and 417 and, as applicable, the regulations specific to fish ( (9 CFR Parts 530 through 555).
E. Not all meat regulations apply to fish. The CSI is to verify ONLY whether the establishment meets those meat inspection regulations cross-referenced in 9 CFR Parts 530 through 555. The CSI is not to verify whether the establishment meets regulations that are not referenced in the fish regulations. The CSI is not to verify whether the establishment meets any poultry regulations.
F. When performing the Pre-Op Sanitation SOP Review and Observations task in fish processing operations, the CSI is to follow instructions for raw processing operations in FSIS Directive 5000.4, Performing the Review Component of PBIS 01B02 Procedure and PHIS Pre-op Sanitation SOP Review and Observation Task in Federally Inspected Processing, Slaughter and Import Establishments.
G. When performing the Review of Establishment Data task, the CSI is also to review any establishment records that pertain to pre-harvest standards and transportation to processing establishments (9 CFR Part 534), in addition to the HACCP records described in FSIS Directive 5000.2, Review of Establishment Testing Data by Inspection Program Personnel. These may include water quality records for ponds and other waters where fish are harvested, and pond treatment records (e.g., chemicals or drugs). CSIs that have concerns that these records demonstrate that fish were raised under conditions that may result in adulterated or unwholesome product (e.g., evidence of heavy metals, pesticides, fertilizers, industrial chemicals or drugs) should verify that the establishment took appropriate action in accordance with their HACCP system. The CSI is to consider how the establishment controls chemical hazards at fish receiving (e.g., HACCP critical control point or pre-requisite program) and whether the establishment implemented those controls. If the CSI has questions about the records or whether a situation demonstrates noncompliance, he or she should seek guidance on the matter from their FLS
H. The CSI is to follow the instructions in FSIS Directive 5420.1, Food Defense Tasks and Threat Notification Response Procedures for the Office of Field Operations, to perform one comprehensive food defense task per quarter. The CSI is to observe as many food-defense practices as possible, but is not expected to walk or drive around the waters where fish are raised (e.g., ponds, raceways, or other bodies of water), even if such bodies of water are on the establishment premises. When completing task question 1, in the Food Defense task, the CSI is to consider whether the establishment has procedures in place to prevent unauthorized access to the ponds or raceways that are located on the establishment premises. If the CSI does not know the answer to a question, he or she is to discuss the question with establishment management at a weekly meeting. Additional information on food defense practices that are specific to fish establishments can be found in FSIS’ Food Defense Guidelines for Siluriformes Fish Production and Processing.
I. The CSI is to perform Other Inspection Requirements verification tasks to determine whether the establishment adequately disposes diseased or otherwise adulterated fish carcasses and parts (9 CFR 539.1), as well as dead fish that exhibit signs of disease, spoilage, or decomposition (9 CFR 540.1).
1. The task location depends on the points in the process where the establishment examines whole fish and fish products for quality or acceptability. This may include various points in the process, such as initial sorting of live fish, or after evisceration of whole fish, or after the fillet, trim, and cutup processes.
2. The CSI is to verify establishment control for the following conditions:
a. Abscesses, sores, ulcers, cysts, nodules, or encapsulated worms;
b. Red spots (petechial hemorrhages) covering more than 50 percent of the tissue;
c. Evidence of spoilage or decomposition in whole fish or processed product (e.g., off odor, slimy tissue, brown to yellowish-gray color);
d. Unusual gross deformities caused by disease or chemical contamination; and
e. Disease, spoilage, or decomposition of dead fish arriving at the establishment.
NOTE: IPP are to be aware that fish that die on the way to the establishment and are received with live fish are not subject to condemnation, unless they are in a diseased or spoiled state. For example, dead fish that arrive on ice in a fishing vessel or other means of conveyance are not subject to condemnation unless they are decomposed or exhibit signs of disease or spoilage.
3. The CSI is to document noncompliance when he or she observes loss of process control. Conditions, as identified in 2 above, that are severe or numerous enough to affect the usability of the product, or the CSI identifies multiple, recurring instances it demonstrates loss of process control and the establishment’s quality procedures failure to discard fish or fish products that exhibit these conditions. The CSI is to cite:
a. 9 CFR 539.1 for conditions described in 2. a. through d. above; or
b. 9 CFR 540.1 for dead fish that exhibit areas of disease, spoilage, or decomposition. Infrequent incidences of disease, spoilage or decomposition on individual fish or fish products would not demonstrate noncompliance; and
c. 9 CFR 301.2(3) the product is unfit for human food.
J. The rules of practice apply to fish inspection actions (9 CFR Part 561).
K. The CSI is to follow the sampling instructions in FSIS Directive 14,010.1.
V. SUPERVISORY RESPONSIBILITIES
A. Supervisory personnel are to assist CSIs in matters involving the verification of regulatory compliance in establishments that process fish.
B. Supervisory personnel are to ensure that CSIs make informed regulatory decisions consistent with statutory authority, properly document inspection findings, and take appropriate actions to prevent adulterated or misbranded fish product from entering commerce.
Refer questions regarding this directive to your district’s Siluriformes Point of Contact (POC) (see attachment 4). If further guidance is required then the POC can contact the Headquarters subject matter experts with specific questions or submit her or his questions to askFISH.
See full PDF for attachments
- Final Rule Requirements
- Fish Regulations
- List of Directives Applicable to CSIs, Who Perform Inspection Verification in Establishments that Prepare or Process Fish
- Primary Siluriformes Contact