United States Department of Agriculture 

Food Safety and Inspection Service

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2016 – Siluriformes Self Reporting Tool - Version 5 (Note: This model SRT is not to be filled out)

Equivalence is a prerequisite for trade for the United States (US) Department of Agriculture’s(USDA) Food Safety and Inspection 

Service (FSIS). Equivalence is the process of determining whether a country’s food safety inspection system achieves FSIS’s appropriate 

level of protection for public health as applied domestically in the US. Additionally, the country’s food safety inspection system is to

provide standards equivalent to FSIS to ensure other non-food safety requirements (such as accurate labeling, and assurance that fish of 

the order Siluriformes products are not economically adulterated)are met. This means that the country is not required to develop and 

implement the same procedures thatthe US does, but rather the country must objectively demonstrate how its procedures meets the US 

level of protection. In order to determine whether a country’s food safety inspection system is equivalent, FSIS assesses information 

collected through a questionnaire called theself-reporting tool (SRT). The SRT is designed for countries that want to export fish of the 

order Siluriformes products to the US. The SRT provides an organized means for the country’s government to demonstrate that its 

inspection system achieves an equivalent level of protection. The SRT is arranged into six (6) components:

1. Government Oversight (e.g., Organization and Administration)

2. Government Statutory Authority and Food Safety and Other Consumer Protection Regulations (e.g., Inspection System 

Operation, Product Standards and Labeling, and Humane Handling)

3. Government Sanitation 

4. Government Hazard Analysis and Critical Control Point (HACCP) System 

5. Government Chemical Residues Testing Programs

6. Government Microbiological Testing Programs

The questions under these six components are called component questions. The country’s central competent authority (CCA) is expected 

to answer all component questions in the SRT in order for an effective determination of equivalence. The CCA is the country’s national 

government authority thatis responsible for ensuring the safety and truthful labeling of the food supply. 

The CCA should provide complete responses to SRT questions. Complete responses include a short narrative, accompanied by supporting 

documentation, to characterize how a country’s food safety inspection system is implemented. Responses should include references to 

where in the supporting documentation the answer to the question is found. For example, answers should include the page number, section 

number, or chapter from the relevant supporting documentation. The CCA will need to submit to FSIS the completed SRT with all 

applicable programs and supporting documentation. Typesof supporting documentation the CCA should include about the government 

inspection system are as follows:

a. food safety and inspection laws and legislation

b. regulations, policies, standards, decisions, annexes, and decrees

c. inspection procedures, manuals, and directives

d. control programs

e. inspection training programs

f. mechanisms for documenting compliance/noncompliance

g. enforcement and compliance programs

Food safety objective-based criteria are the standards that FSIS uses to determine whether the country’s food safety inspection system is 

equivalent. The component questions are the food safety objective-based criteria that FSIS uses to determine equivalence in the form of a 

question.

Submission of the SRT

To submit the SRT with all applicable programs and supporting documentation, the CCA can either use the Microsoft Word version of 

the SRT or upload the information into the web-based Public Health Information System (PHIS). The benefits for using PHIS to submit 

the information include anexpedited SRT review, transparency, and security. To ensure an expedited review of a submitted SRT,

particularly an SRT submitted in PHIS, FSIS encourages countries to submit SRT responses and supporting documentation in English. 

If the CCA submits SRT responses and supporting documentation in a language other than English, FSIS will send the documentation 

for translation into English, and place the translated English responses into the SRT. FSIS maintains all countries SRT responses and

submitted supporting documentation in PHIS. Through PHIS the CCA will have the opportunity to verify thatthe translated responses 

are accurately captured by FSIS in PHIS. For countries that submitted paper SRT responses, the CCA will be provided an opportunity to 

verify a paper copy of the English translatedSRT responses entered into PHIS. Note that by not communicating the SRT responses in 

English and byusing a paper copy rather than PHIS for inputting SRT information by the CCA, the equivalence reviewprocess could be 

delayed by weeks and possibly months. Importantly, regardless of how the CCA managesthe SRT, FSIS relies upon the PHIS English 

version of the SRT responses when making equivalence decisions. Countries are encouraged to gain access to PHIS in order to ensure 

completeness of documentation of the SRT.
United States Department of Agriculture 

Food Safety and Inspection Service

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FSIS, using food safety objective-based criteria, will then review the SRT responses and associated supporting documentation to 

determine whether the country’s food safety inspection system isequivalent. After FSIS completes its review, FSIS will send to the CCA 

any clarification questions, and make the English translated SRT responses and supporting documentation available for review in PHIS (or 

send a paper version if paper was previously provided). Through this process, the CCA will have the opportunity to verify that the 

translated responses and supporting documentation are accurate, and,if applicable, provide clarification to FSIS’s questions.

On-going Equivalence Verification

After equivalence is granted, on an annual basis no later than May 18, the CCA must either (1) update its SRT responses, or (2) 

communicate to FSIS that the CCA has verified its SRT responses, as recorded in PHIS (i.e., by reviewing the SRT electronically in 

PHIS or by hard copy of the version of SRTresponses FSIS has entered for the CCA), are accurate and complete. Updates to its SRT are 

expected wheneverthe CCA makes changes to its food safety inspection system, whether the change is a result of the country’s changes 

or the US implements new policies that may impact the design of the CCA’s food safety inspection system for products exported to the

US.

In addition, the CCA must provide the following on an annual basis no later than May 18th, if applicable for the eligible product(s):

1. An up-to-date list of all certified establishments eligible to export to the US.

2. An updated government residue control program, including the previous year’s residue test results and reactions to residue 

findings.

3. An updated microbiological sampling and testing program, including the previous year’s test results and reactions to Salmonella

in raw fish of the order Siluriformes and Listeria monocytogenes, Salmonella, or other pathogens of public health concern in 

ready-to-eat (RTE) fish of the order Siluriformes.

Siluriformes Inst. 1

The following questions are required and will be used to determine the equivalence with FSIS standards pertaining to government 

oversight and authority. In summary, the FSIS criteria for this section includes identifying the CCA’s authority, laws, and 

regulations governing the inspection system for fish of the order Siluriformes for certified establishments who will be exporting to 

the US, and the staffing requirements and procedures.

Government 

Oversight 1

How does the CCA ensure that the laws and regulations governing fish of the order Siluriformes 

inspection are enforced?

NOTE: The CCA is a country’s national government authority who is responsible for ensuring the 

safety of the food supply.

NOTE: Please identify the name of the CCA, and attach an organizational chart.

Government 

Oversight 2

How does the CCA ensure that all fish of the order Siluriformes products for export to the US are 

certified, and not adulterated and properly labeled and packaged (not misbranded)?

NOTE: Please define adulterated product as it relates to fish of the order Siluriformes.

Government 

Oversight 3

How does the CCA ensure that the same set of laws, regulations, and policies are applied consistently 

to all certified establishments that manufacture fish of the order Siluriformes are eligible to export to 

the US?

NOTE: A certified establishment is an establishment that the CCA determines as meeting US 

requirements and, therefore, eligible to export fish of the order Siluriformes products to the US.

NOTE: A de-certified establishment is an establishment that the CCA determines as not meeting US 

requirements and, therefore, not eligible to export fish of the order Siluriformes products to the US. 

NOTE: Countries are required to notify FSIS when there are changes in the eligibility of certified 

establishments, and must confirm with FSIS at least annually (by May 18th) all certified 

establishments eligible to export to the US.
United States Department of Agriculture 

Food Safety and Inspection Service

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Government 

Oversight 4

How does the CCA ensure that source product from fish of the order Siluriformes used in processing 

operations originates only from certified establishments in eligible countries?

NOTE: An eligible country is a country that the US has already determined to have an equivalent 

meat, poultry, or egg products inspection system.

Government 

Oversight 5

How does the CCA ensure that US import requirements are communicated to certified establishments 

as import requirements are issued?

Government 

Oversight 6

Government 

Oversight 7

Government 

Oversight 8

Government 

Oversight 9

How does the CCA ensure that an ongoing staffing plan provides continuous governmentinspection for 

the production of safe, wholesome, and accurately labeled fish of the order Siluriformes products in 

certified establishments?

How does the CCA ensure that government inspection personnel assigned to certified establishments 

exporting fish of the order Siluriformes products to the US are employees of and paid by the government? 

NOTE: Criteria for government inspection include the following:

a. Government inspector – inspector employed directly by the government on a permanent or 

intermittent basis, and who is authorized to perform all aspects of inspection.

b. Licensee (Limited Government Inspector) – inspector employed under individual contractby the 

government to perform inspection.

c. Contract employee (Private Contractor) – operator employed by a third party organization 

contracted to conduct inspection activities on behalf of the government. Operator is under the 

direct supervision of a government inspector; however, without government supervision in place, 

this classof operator would fail to meet FSIS government inspection criteria.

d. Government-authorized establishment employee – operator performing sorting and assessment 

activities under the direct supervision of a government inspector. Also refers to an operator 

directed to perform activities not specifically related to inspection.

NOTE: In items b, c, and d, the final inspection and disposition must be made by a government inspector 

based upon issues identifiedby non-government personnel.

How does the CCA ensure that government inspection personnel have appropriate educational 

credentials, disciplinary backgrounds, and training to carry out their inspection tasks?

How does the CCA ensure that specialized, ongoing training on the US import requirementsis provided 

to government inspection personnel assigned to certified establishments?

NOTE: Examples of types of training include food safety, sanitation requirements, sample collection 

procedures, and compliance verification.
United States Department of Agriculture 

Food Safety and Inspection Service

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Government 

Oversight 10

Government 

Oversight 11

How does the CCA ensure that adequate administrative and technical support is available to certified 

establishments and laboratories performing food safety testing?

How does the CCA ensure that laboratories testing chemical residues for fish of the order Siluriformes 

products for export to the US comply with the general criteria for testing laboratories provided in 

International Organization for Standardization (ISO)/International Electrotechnical Commission 

(IEC) Guide 17025?

Government 

Oversight 12

How does the CCA ensure that methods of analysis (including both sampling and testing 

procedures) used for food safety testing have been scientifically validated or have been approved and 

adopted by a recognized international organization?

Government 

Oversight 13

How does the CCA ensure that internal quality control procedures for laboratories are established, 

effective, and followed?

Siluriformes Statutory Authority Instructions

The following questions are required and will be used to determine the equivalence with FSIS standards.

Government 

Statutory 

Authority and 

Food Safety 1

Government 

Statutory 

Authority and 

Food Safety 2

Government 

Statutory 

Authority and 

Food Safety 3

Government 

Statutory 

Authority and 

Food Safety 4

Government 

Statutory 

Authority and 

Food Safety 5

How does the CCA ensure that government inspection personnel perform continuous inspection at 

certified establishments during all hours of operation while fish of the order Siluriformes are 

slaughtered, for example beheading and eviscerating?

How does the CCA ensure government inspection occurs at least once per shift at certified 

establishments while fish of the order Siluriformes are processed, for example filleting and breading?

How does the CCA ensure that a representative of the government inspection system makes periodic 

supervisory visits to each certified establishment?

How does the CCA ensure that the food safety inspection system provides for complete separationof 

certified from non-certified establishments?

NOTE: Any fish of the order Siluriformes products intended to be exported to the US cannot be produced 

in an establishment (or part of an establishment) that was not certified as eligible to export to the US.

NOTE: If a certified establishment also produces fish of the order Siluriformes products not 

intended for export to the US, the products not intended for export to the US must be produced 

separately by either time or space.

How does the CCA ensure control over condemned of fish of the order Siluriformes, which can include 

portions of inspected fish of the order Siluriformes, and inedible material until destroyedor otherwise

denatured?

NOTE: A condemned fish of the order Siluriformes or inedible material is any fish of the order 

Siluriformes, part of a fish of the order Siluriformes carcass, or fish of the order Siluriformes-based 

product that is determined not fit to be eaten by humans.

NOTE: The denaturing of fish of the order Siluriformes products is to add a chemical substance, 

e.g. charcoal or dye, to ensure that the product cannot be used for human food.
United States Department of Agriculture 

Food Safety and Inspection Service

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Siluriformes Government Sanitation Instructions

The following questions are required and will be used to determine the equivalence with FSIS standards pertaining to 

sanitation. The inspection system must require that each certified establishment operate in a manner to prevent insanitary 

conditions, and develop, implement, and maintain written standard operating procedures for sanitation.

Government 

Sanitation 1

Government 

Sanitation 2

Government 

Sanitation 3

Government 

Sanitation 4

Government 

Sanitation 5

Government 

Sanitation 6

Government 

Sanitation 7

How does the CCA ensure that fish of the order Siluriformes for use as human food are not grown 

or farmed under conditions that would cause them to be inedible?

How does the CCA ensure (for cause) samples of feed, fish of the order Siluriformes, or pond water 

are collected for the purpose of verifying that they are being raised under sanitary conditions?

How does the CCA ensure that fish of the order Siluriformes are transported under sanitary 

conditions from ponds to the certified establishment?

How does the CCA ensure producers exercise controls to separate fish of the order Siluriformes 

that have died other than by slaughter?

How does the CCA ensure that each certified establishment operates in a sanitary manner?

How does the CCA ensure that certified establishment’s construction, facilities, and equipment 

prevent the contamination or adulteration of fish of the order Siluriformes products designated for 

exportto the US?

How does the CCA ensure that each certified establishment develops, implements, and maintains daily 

pre-operational and operational sanitation procedures sufficient to prevent the direct contamination 

or adulteration of fish of the order Siluriformes products?

Siluriformes Government HACCP System Instructions

The following question is required and will be used to determine the equivalence with FSIS standards pertaining to HACCP. 

The inspection system must require that each certified establishment develop, implement, and maintain a HACCP plan. An 

equivalent HACCP plan will achieve the food safety objective of preventing and controlling, biological, chemical, and 

physical hazards in products shipped to the US.

Government 

Oversight 1

Government 

HACCP 

System 1

How does the CCA ensure the implementation and maintenance of a fish of the order Siluriformes 

productsfood safety inspection system that prevents and controls identified food safety hazards?

Siluriformes Chemical Residues Testing Instructions

The following questions are required and will be used to determine the equivalence with FSIS standards pertaining to 

chemical residue testing programs. The inspection system must have a chemical residue control program, which includes 

sampling for chemical residues identified by the CCA or by FSIS as potential contaminants.

Government 

Chemical 

Residues 

Testing 

Programs 1

Government 

Chemical 

Residues 

Testing 

Programs 2

How does the CCA ensure the implementation and maintenance of a national chemical residue control 

program that prevents and controls all specific compounds of concern both domestically and in the US?

NOTE: Please submit annually (by May 18th) your updated residue control program, previous year’s 

residue test results, and reactions to residue findings.

How does the CCA ensure chemical independence of one production lot from another during government 

testing of fish of the order Siluriformes?
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Food Safety and Inspection Service

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Government 

Chemical 

Residues 

Testing 

Programs 3

Government 

Chemical 

Residues 

Testing 

Programs 4

How does the CCA ensure that the industry will define what will be considered a production lot? 

NOTE: This information is important because FSIS can use it to conduct a recall of fish of the order 

Siluriformes in the event that there is a detection of non-compliance in fish of the order Siluriformes from 

your country,

How does the CCA ensure control over government sampled fish of the order Siluriformes until test 

results are received for chemical residue verification testing?

Siluriformes Microbiological Testing Instructions

The following questions are required and will be used to determine the equivalence with FSIS standards pertaining to 

any government testing programs the CCA maintains. Under this section, countries should capture all food safety 

controls (including sampling and other verification activities) that address Salmonella, Listeria monocytogenes, and 

other pathogens of public health concern.

Government 

Microbiological 

Testing Programs 

1

How does the CCA ensure the implementation and maintenance of its fish of the order Siluriformes food 

safety inspection system’s microbiological sampling program?

Government 

Microbiological 

Testing 

Programs 2

Government 

Microbiological 

Testing 

Programs 3

How does the CCA ensure that the inspection system’s microbiological sampling program includes 

supportable sample collection procedures, frequencies, and test methods?

NOTE: Please include the sample collection requirements and controls that ensure the sample 

integrity, reliability, and chain of custody.

How does the CCA ensure the reduction of Salmonella in raw fish of the order Siluriformes products 

through sampling and other verification activities?

NOTE: Please submit annually (by May 18th) your updated microbiological sampling and testing 

program, previous year’s test results, and reactions to positive results.

Government 

Microbiological 

Testing 

Programs 4

How does the CCA ensure that ready-to-eat (RTE) fish of the order Siluriformes products are free of 

Listeria monocytogenes, Salmonella, or other pathogens of public health concern through sampling and 

other verification activities?

NOTE: RTE products are products that are edible without further preparation.

NOTE: Please submit annually (by May 18th) your updated microbiological sampling and testing 

program, previous year’s test results, and reactions to positive results. Provide all supporting 

documentation that you use to verify the elimination of Listeria monocytogenes, Salmonella, or other 

pathogens of public health concern in RTE products.

Government 

Microbiological 

Testing 

Programs 5

How does the CCA ensure that thermally processed/commercially sterile fish of the order Siluriformes 

products are free of microorganisms capable of growing in non-refrigerated conditions in storage and 

distribution (over 50°F or 10°C) through sampling and other verification activities?

NOTE: Thermally processed or commercially sterile product is a shelf-stable product that has had an 

application of heat, irradiation, high-pressure, or other processes or ingredients, applied alone or in 

combination, that causes the product to become free of microorganisms capable of growing at nonrefrigerated temperatures.

NOTE: A process schedule contains all required factors applied to make a thermally 

processed/commercially sterile product shelf stable.

NOTE: A process authority can be a person or organization that has expert knowledge of the 

requirements to produce a thermally processed/commercially sterile product.
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Food Safety and Inspection Service

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Government 

Microbiological 

Testing 

Programs 6

Government 

Microbiological 

Testing 

Programs 7

Government 

Microbiological 

Testing 

Programs 8

NOTE: Please submit prior to production for export to the US updated processing schedules for 

each certified establishment’s product that is developed by a processing authority.

How does the CCA ensure control over government sampled fish of the order Siluriformes until the test 

results are received for microbiological or economic adulteration verification testing?

How does the CCA ensure that fish of the order Siluriformes sampled and found to be positive for an 

adulterant (e.g., Listeria monocytogenes or Salmonella in RTE fish of the order Siluriformes product) is not 

retested to negate the previous result?

Have the documents and answers to the SRT questions provided by the CCA been translated correctly by 

the US? 

NOTE: All translated documents will be uploaded in the document section with the word TRANSLATED 

in all capital letters at the beginning of the title for review.
United States Department of Agriculture 

Food Safety and Inspection Service

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