Attachment_10.pdf

DATE OF ISSUANCE: TRANSMITTAL NO.: PAGE 1

FORM FDA 2438 (7/92)

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7303.842

CHAPTER 03 - FOODBORNE BIOLOGICAL HAZARDS

SUBJECT:

Seafood Processor Inspection Program – Domestic and Foreign Facilities

IMPLEMENTATION DATE

Upon Receipt

COMPLETION DATE

Continuous

DATA REPORTING

PRODUCT CODES PRODUCT/ASSIGNMENT CODES

INDUSTRY CODE 16, USE APPROPRIATE

PRODUCT CODES

Note:

It is not necessary to attribute time specifically to PPS areas other than 03, unless a substantial amount of time is spent in other PPS areas. For example, if problems are noted in the area of chemical contamination requiring investigational follow-up, then report that time under 04842H.

(Report both FDA and State Partnership work under PACs 03842 and 03842H. The Position Class will be used to distinguish between the State Partnership and FDA accomplishments.)

1.

LABS REPORT SAMPLE ANALYSIS UNDER

THE FOLLOWING PACS:

03842B Filth 03842C Decomposition 03842D Microbiological (includes

% water phase salt) 03842H HACCP Microbiological and

HACCP Decomposition Verification

04842A Chemical Contamination

07842 ASP, DSP, NSP, AZP, CFP,

TTX, and PSP 07842H HACCP ASP and PSP

Verification 09842E Color Additives 09842F Food Additives 09842H HACCP Color and Food

Additives Verification

2.

REPORT ALL OTHER OPERATIONS FOR PMS

03, 04, AND 09, ONLY UNDER THE

FOLLOWING PACS:

03S001 - Foodborne Biological Hazards (Non-safety) – State Contract

03S002 - Seafood HACCP: State Contract

03842 - Foodborne Biological Hazards [non-safety] and all Documentary samples

03842H - Seafood HACCP 04842H - Chemical Contamination 09842 - Food and Color Additives 03R233 Inspections of Foreign

Processors 03803E Targeted Allergen

Inspection

PROGRAM 7303.842

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FORM FDA 2438g (10/91)

Note: See note regarding Food Economics under Laboratory Reporting on the next page prior to using PAC 21842

3. REPORT ALL OPERATIONS FOR THE

FOLLOWING AREAS UNDER THE DESIGNATED

PACS:

21005 NLEA/FPLA/FALCPA (Food Allergen Labeling Consumer Protection Act) /and other general labeling

21R829 All activities involving nutritional health fraud issues

21842 Domestic Fish and Fishery Products (Econ/Label)- Please see note in the section on LABORATORY REPORTING before doing any activity using this

PAC

LABORATORY REPORTING

Report the following analytical results into the FACTS Data System:

1. Biotoxins (Natural Toxins) Use PAF: BIO

2. Color Additives Use PAF: COL

3. Decomposition Use PAF: DEC

4. Filth Use PAF: FIL

5. Food Additives Use PAF: FAD

6. Microbiology Use PAF: MIC

Salmonella Speciation use sub-PAF SAL

Antibiotic Resistance use sub-PAF ABR

PFGE - Salmonella use sub PAF GSA

PFGE – L. monocytogenes use sub PAF GLI

PFGE – V. cholerae use sub PAF GVC

PFGE – V. parahaemolyticus use sub PAF GVP

PFGE – C. botulinum use sub PAF GCB

Percent (%) Water Phase Salt and Nitrate use sub-PAF WPS-NTR pH use sub-PAF NAR

7. Parasites Use PAF: PAR

8. Pesticides Use PAF PES

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FORM FDA 2438g (10/91)

10. Note: Limited resources are available for Food Economics issues.

CFSAN’s current priorities focus on food safety. Districts should follow-up on consumer or industry reports of economic fraud; however, general surveillance activities should receive CFSAN concurrence prior to expending District resources. CFSAN may periodically issue special assignments to address food economics issues.

If economic work is conducted under this program, use the appropriate PAF:

FDL- labeling FDE- economic deception FDQ- standard of quality FDI- standard of identity

DATE OF ISSUANCE: TRANSMITTAL NO PART I PAGE 1

FORM FDA 2438 g (10/91)

PART I – BACKGROUND

This compliance program provides regulatory coverage of firms that process fish and fishery products to ensure a safe and wholesome domestic seafood supply. This program provides direction to the field for developing inspectional skills and focus and instructions specific to the inspection of seafood processing facilities and products.

FDA currently conducts inspections of both domestic and foreign seafood processors to determine compliance with 21 CFR, Part 123, the “Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products” Final Rule (the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (http://www.fda.gov/Food/FoodSafety/Product- SpecificInformation/Seafood/SeafoodHACCP/ucm111304.htm?utm_campaign=Google2&u tm_source=fdaSearch&utm_medium=website&utm_term=Seafood%20HACCP%20final%20rul e&utm_content=1). This compliance program contains instructions for both domestic and foreign processor inspections.

The Office of Food Safety, Division of Seafood Safety has associated certain seafood products with specific safety hazards (http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/Gu idanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/UCM25 2383.pdf). The current regulatory strategy outlined in this program prioritizes areas of concern based on a risk assessment that considers, at a minimum, the severity of health consequences associated with the hazard and industry compliance history.

CFSAN continues to integrate investigational activities between the Import Compliance Program and the Seafood Processor Inspection Program – Domestic and foreign and Foreign Facilities. The Office of Food Safety, Division of Seafood Safety has determined that data gathered during domestic investigations of importers provides a valuable targeting mechanism to assure that foreign inspection resources are directed towards foreign processors that have failed to comply with the seafood HACCP regulation. Additionally, data gathered during foreign investigations of processors can, in turn, help CFSAN determine importers that are accepting product from foreign processors that are not in compliance with the seafood HACCP regulation, and provide insight into the reliability of third party inspections and foreign certification programs.

The Seafood Processor Inspection Program – Domestic and Foreign Facilities, CP 7303.842, continues to provide coverage to processors and products that are not covered under the Molluscan Shellfish Evaluation Program CP 7318.004 and additional coverage to processors and products covered under the Acidified and Low Acid Canned Food Compliance Program CP 7303.003A, i.e., hermetically sealed low-acid seafood and acidified shelf stable seafood for hazards that are not addressed by those programs.

DATE OF ISSUANCE: TRANSMITTAL NO: PART II PAGE 1

FORM FDA 2438 g (10/91)

PART II - IMPLEMENTATION

OBJECTIVE

The primary objective of this program is to ensure a safe and wholesome fish and fishery products supply in the U.S. This is done through inspections of both domestic and foreign establishments that process seafood products intended for consumption in the U.S. to determine if they have met the requirements of 21 CFR 123 and other applicable U.S. regulations.

APPROACH

The Seafood Processor Inspection Program – Domestic and Foreign Facilities covers all seafood processing activities. It incorporates an evaluation of the processors’ seafood HACCP controls required by 21 CFR 123 and an inspection of conditions against the requirements of 21 CFR 110. Selection and prioritization of processors and products for inspection will be risk based. Investigators who meet the training requirements for conducting seafood HACCP inspections will approach inspections by doing their own hazard analysis, evaluating HACCP plans or the controls in the absence of a plan;

evaluating sanitary conditions; determining if the HACCP plan and sanitation monitoring are being implemented, that corrective actions are being taken when necessary, reviewing records and citing deficiencies. It is important that the investigator be present at the firm to evaluate the entire operation from start-up to finish, including any sanitation procedures at the beginning and end of the operation, and observe the firm’s implemented sanitation monitoring procedures.

Inspections should be conducted in accordance with the inspection components outlined in the Conducting Seafood Inspections Training Course and the Investigations Operations Manual.

PROGRAM MANAGEMENT INSTRUCTIONS

A. PROGRAM PRIORITIES AND RESOURCE UTILIZATION

1. Resources shown in the ORA workplan can be used to cover PPS 03, 04, 07, 09 and 21 using instructions provided in this program.

It is not necessary to attribute time specifically to any one PAC other than 03, unless a substantial amount of time is spent in other specific areas. For example, if problems are noted in the area of chemical contamination requiring investigational follow-up, then report that time under 04842H.

2. Please note that re-inspections of OAI firms should not be conducted until good faith efforts by the firm to correct and address the significant problems have been completed.

Priorities for foreign processor inspections may vary from domestic and foreign priorities based on country specific

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DATE AMMENDED:

FORM 2438 g (10/91) problems, emerging issues, and controls through other means such as import alerts.

3. Products and processors in Risk Areas A, B, and C are considered high regulatory priorities. Products and processors in Risk Area E is a low regulatory priority. The Compliance Program Priorities are listed in descending order below:

Risk Classification of Processor Facility Type

A. Processors of “High risk potential” product types A, B, C, D, E, and F (as listed in A., 3 below)

1.Domestic and foreign processors whose last inspection was classified OAI

2. Domestic and foreign processors whose last inspection was classified VAI for HACCP violations

3. Processors that have never had an FDA or equivalent FDA-contracted State inspection

B. Processors of “High risk potential” product types G, H, and I (as listed in A., 3 below)

1.Domestic and foreign processors whose last inspection was classified OAI

2. Domestic and foreign processors whose last inspection was classified VAI for HACCP violations

3. Processors that have never had an FDA or equivalent FDA-contracted State inspection

C. Processors of “High risk potential” product types A, B, C, D, E, F, G, H , and I (as listed in A., 3 below)

1.Domestic and foreign processors whose last inspection was classified NAI

D. Processors of products that are not classified as “high risk potential” or “low risk potential” and are associated with hazards that are considered of regulatory significance.

1.Domestic and foreign processors whose last inspection was classified OAI

2. Domestic and foreign processors whose last inspection was classified VAI for HACCP violations

3. Processors that have never had an FDA or equivalent FDA-contracted State inspection

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E. Processors of products that are associated with “Low risk potential” (as listed in A., 4 and 5 below) hazards and products that have no associated food safety hazards.

1.Domestic and foreign processors whose last inspection was classified OAI

2. Domestic and foreign processors whose last inspection was classified VAI.

2. Domestic and foreign processors who have never had an FDA or equivalent FDA-contracted State inspection

3. Domestic and foreign processors whose last inspection was classified NAI

Frozen storage warehouses that request inspections to obtain an FEI number in order to be added to the European Union Approved List must be inspected. Although they are not a high priority, these inspections should be accomplished in a timely manner.

4. “High risk potential” products and processes are listed below.

Some seafood products may fall into more than one category. For the purposes of this program "high risk potential" products and processes include the following

Product or Process Type Description Risk

A. Refrigerated seafood products packed in Reduced Oxygen Packaging

(ROP)

ROP is oxygen impermeable or oxygen limiting packaging that reduces the transmission rate of oxygen to levels that can result in potentially unsafe conditions if refrigeration or secondary barriers are inadequate. Examples include cans, jars, lidded plastic containers with a heat sealed inner liner, vacuum packaging, heat sealed plastic bags, packaging where air has been manually expressed and the bag sealed, seafood packed in oil, and pasteurized seafood.

The hazard of concern is C. botulinum growth and toxin formation. The severity of health consequences associated with this hazard elevates the risk associated with the products.

ROP seafood products usually require either strict temperature control and/or processes that are usually complex and require multiple HACCP controls to ensure a safe product.

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See Chapter 13 of the Seafood HACCP Guide* for additional information

B. Processed uneviscerated finfish(e.g.

cooked, acidified, salted, dried, or partially dried)

Such as Kapchunka, alewives, or bloaters

The hazard of concern is C. botulinum growth and toxin formation. (C.

botulinum is present in the environment and consequently present in the fish viscera.)

Immediate regulatory action may be necessary when these product or processes are encountered. CFSAN should be contacted when these products or processes are encountered.

C. Raw molluscan shellfish and products that include raw molluscan shellfish that will not be cooked prior to consumption

Such as clams, mussels, whole scallops, oysters, and seafood mixes that contain molluscan shellfish

Hazards include Vibrio spp., Salmonella, Hepatitis A, Cholera spp.

Norovirus and marine toxins.

A significant number of illnesses are directly attributed to consumption of raw molluscan shellfish.

See Item H in this section for additional inspectional coverage information

D. Cooking, smoking, fermentation, acidification processes, or drying process for RTE dried seafood

Products include heat treated seafood products (e.g., cooked shrimp, crabmeat, cooked lobster, cooked crayfish, hot smoked, etc.)

OR

Cold smoked seafood

OR

Refrigerated pickled seafood

The primary food safety hazards of concern include C. botulinum for products in ROP packaging, L.

monocytogenes, and S.

aureus growth and toxin formation.

These processes are normally complex and require multiple HACCP and strict sanitation controls to ensure a safe product.

* Fish and Fisheries Products Hazards and Controls Guidance

DATE OF ISSUANCE: TRANSMITTAL NO: PART II PAGE 3

OR

Seafood pastes

E. Scombrotoxin-forming (histamine-forming) species

Table 3-A in the Seafood HACCP Guidance will provide the species of concern.

Scombrotoxin (histamine) is a heat stable toxin that is not eliminated through thermal processing or acidification.

A significant number of illnesses are associated with scombrotoxin forming species.

F. Ready-to-Eat (RTE) seafood processors who do NOT operate cooking, smoking, fermentation, or acidification operations, but receive, store, manufacture, or otherwise process RTE seafood.

RTE seafood Examples include:

Caviar, fish roe, urchin roe, pickled fish, or raw fish intended for sashimi or sushi, cold smoked fish, ceviche, pickled fish

OR

Products prepared from RTE fisheries products including seafood salads, seafood sandwiches, seafood spreads, seafood dips, seafood mixes

OR

Refrigerated products listed in Item D.

OR

RTE dried seafood

The primary pathogen of concern is usually L.

monocytogenes, however other pathogens may also be of concern.

Parasites may be a hazard in products intended for raw or undercooked consumption, such as sashimi, pickled fish, ceviche, cold smoked fish, and sushi. Refer to Chapter 5 and Tables 3-2 and 3-3 in the Fish and Fishery Products Hazards and Controls Guidance for further information on the parasite hazard.

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G. Formulated seafood products containing multiple ingredients

AND

Products where sodium metabisulfites or FDA Yellow No.5 are likely to be used.

Examples include seafood mixes, soups, chowders, salads, pastas, meals, battered or breaded seafood, spreads, surimi analogs, dips, sandwiches, sushi

OR

Chapter 19 of the Seafood HACCP Guidance can provide additional information with regards to species associated with undeclared food intolerance substances

The food safety hazard of concern is undeclared allergens and food intolerance substances.

H. Aquacultured seafood

Table 3-A in the Seafood HACCP Guidance will provide the species of concern.

The food safety hazards of concern are the use of unapproved aquaculture drugs and the improper use of aquaculture drugs.

Chemotherapeutics in Seafood Compliance Program, CP 7304.018.

An increased incidence of unapproved drug residues is associated with imported aquacultured species. Foreign processors should have an increased priority for inspection.

5. The following food safety hazards are considered a “low risk potential”, - metal inclusion, glass inclusion, environmental chemicals, and methyl mercury. Deficiencies with regards to these hazards should be noted as FDA 483 Observations but Districts should not routinely pursue regulatory discretion for deficiencies associated with these hazards. It is recommended that the districts contact CFSAN for concurrence of charges associated with these hazards

6. Food safety hazards that are not listed as a “low risk potential” are considered significant and regulatory action should be considered when deficiencies associated with these hazards occur.

B. IDENTIFICATION OF A DISTRICT SEAFOOD COORDINATOR

Each District MUST designate a "District Seafood Coordinator" to be listed in the IOM.

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C. SAMPLE COLLECTION

Samples of seafood products should not be collected to support seafood HACCP charges. Samples may be collected if an investigator is unsure if critical limits are adequate based on the Seafood HACCP Guidance or consultation with CFSAN, but not when controls are clearly inadequate.

Samples can be collected in response to illness outbreaks or as follow-up on consumer or industry complaints. CFSAN may periodically issue special assignments to address food economics issues or as targeted assignments for emerging issues.

See Part III E “Sampling” for complete sampling instructions.

The current ORA Field Workplan provides resources primarily for “for cause” sample collection and analysis.

D. SPECIAL HACCP REPORTING

This Compliance Program will utilize a special HACCP reporting form FDA 3501.

FDA investigators are now to use the electronic version.

Instructions for use of the forms are located at the top of the page. There are different links for creating forms for domestic and foreign and foreign inspections.

E. INTERACTION WITH OTHER PROGRAMS/ASSIGNMENTS

Note: All CFSAN Compliance Programs can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation /ComplianceEnforcement/ucm071496.htm

1. Domestic Acidified and Low Acid Canned Foods, CP 7303.803A

The Domestic Acidified and Low Acid Canned Foods Program, CP 7303.803A covers the safety hazards associated with the control of Clostridium botulinum toxin through the sterilization or acidification. This program covers HACCP controls addressing hazards that are not eliminated through thermal process or acidification.

Resources expended in inspections of firms for compliance with the low acid canned foods regulation (21 CFR 113) or the acidified foods regulation (21 CFR 114) must be reported under CP 7303.803A.

Inspectional coverage of acidified or canned seafood related to other safety hazards, (e.g., histamine, food/color additives, or decomposition) is to be reported under this program CP 7303.842.

2. Molluscan Shellfish Evaluation Compliance Program, CP 7318.004

FDA inspections of raw (fresh and fresh frozen) molluscan shellfish under this program should only be conducted when the shellfish are processed in a state that does not participate in the NSSP. Processors who do not participate in the NSSP but http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm071496.htm http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm071496.htm

DATE OF ISSUANCE: TRANSMITTAL NO: PART II PAGE 6

operate within a participating state should be reported to the local shellfish authority. To determine if an operator or state participates in the ISSC, refer to the Interstate Certified Shellfish Shippers List (ICSSL) at http://www.fda.gov/Food/FoodSafety/Product- SpecificInformation/Seafood/FederalStatePrograms/InterstateShellf ishShippersList/default.htm FDA evaluates State inspectional coverage of shellfish growing areas and shellfish shippers under The Molluscan Shellfish Evaluation Program, CP 7318.004. After reviewing the states’ accomplishments FDA refers any problem to the appropriate State for follow-up. Inadequate State follow-up or unresolved issues are referred to the Interstate Shellfish Sanitation Conference (ISSC) for resolution. Coverage under this program, CP 7303.842, is provided only if appropriate action cannot be achieved within the structure of the National Shellfish Sanitation Program

(NSSP).

3. NLEA, Nutrition Sampling and Analysis, and General Labeling Requirements – Domestic and Import, CP 7321.005

NLEA coverage will be conducted during routine inspections conducted under the Seafood Processor Inspection Program – Domestic and foreign and Foreign Facilities of firms that are labeling or relabeling fish and fishery products. Coverage will be reported under the compliance program CP 7321.005.

This program covers the HACCP controls that assure that accurate product labeling occurs.

4. Pesticides and Industrial Chemicals in Domestic and Imported Foods CP 7304.004

Coverage will be conducted to determine compliance with the pesticide residue regulation and directed to firms and products for which there is little or no information from previous years’ sampling, or for firms that have a violative history for pesticide or chemical contamination of seafood.

5. Toxic Elements in Foods, Foodware, and Radionuclides in Foods, Domestic and Imported, CP 7304.019

Coverage will be conducted to develop broader background level data for certain toxic elements in foods, including seafood.

Primary interest is in lead and cadmium.

6. Chemotherapeutics in Seafood Compliance Program, CP 7304.018 Coverage consisting of sample collections will be conducted to evaluate compliance with regulations governing the use of chemotherapeutic agents in seafood. This program covers inspection of primary processors of aquacultured seafood products.

F. FEDERAL/STATE CONTRACTS AND PARTNERSHIPS

Contracts exist with a number of states to inspect seafood establishments. This program will be incorporated by reference in these contracts as guidance in conducting fish and fishery product sanitation inspections.

DATE OF ISSUANCE: TRANSMITTAL NO: PART II PAGE 7

All seafood inspections conducted either under state contract or partnership must be conducted in accordance with the inspection components in the Conducting Seafood Inspections Training Course. The inspections must be based on the Seafood HACCP regulation and FDA recommendations as opposed to local state requirements. Districts must ensure that state inspectors assigned to do HACCP inspections are HACCP trained, i.e., they have successfully completed a Seafood HACCP Alliance 3-day course or its equivalent and successful completion of the Conducting Seafood Inspections Training Course including passing the course examination, and the Food Microbiology Control Course.

In anticipation of moving towards HACCP-based partnerships for the inspection of seafood processors, the Agency has developed a model FDA-state partnership agreement. Partnership agreements with state regulatory agencies for the inspection of seafood processors should be consistent with this model which can be found at http://www.fda.gov/ForFederalStateandLocalOfficials/PartnershipsContrac ts/CurrentPartnershipAgreements/ucm116013.htm

Inspectors conducting contract or partnership seafood HACCP inspections must also complete the form FDA 3501. They can access their link for FDA 3501 through ESAF.

http://www.fda.gov/ForFederalStateandLocalOfficials/PartnershipsContracts/CurrentPartnershipAgreements/ucm116013.htm http://www.fda.gov/ForFederalStateandLocalOfficials/PartnershipsContracts/CurrentPartnershipAgreements/ucm116013.htm

DATE OF ISSUANCE: TRANSMITTAL NO: PART III PAGE 1

DATE AMMEND

FORM FDA 2438g (10/91)

PART III - INSPECTIONAL

Domestic and foreign seafood HACCP inspections are to be performed according to the instructions that follow, including the completion of a Form FDA 3501.

For scientific and technical HACCP questions that are not address in the Guide during and following inspection, contact the either a National Expert or the Seafood Technical and Policy Branch at (240)402-2300.

For inspectional instructions and procedures, investigators are advised to refer to the following references:

Conducting Seafood Inspections Training Manual - HACCP inspection procedures/activities;

Fish and Fishery Products Hazards and Controls Guidance (FFPH&CG) - Hazards and recommended controls for seafood processors, most recent edition;

Food Microbiological Control Manual, most recent edition;

Office of Food Safety (Division of Seafood Safety) “Supplemental Inspection Instructions”.

Sanitation Control Procedures for Processing Fish and Fishery Products

Additional references listed in Part VI.

A. Training Requirements

Investigators performing seafood inspections (state and federal) must have successfully completed the following courses:

• Seafood HACCP Alliance 3-day course or its equivalent such as The Seafood Alliance Internet 2 day on-line course plus Segment 2 (a third day of live instruction by a certified seafood HACCP instructor)

• “Conducting Seafood Inspections” Training Course

It is suggested that investigators performing seafood inspections (state and federal) also completed the following courses.

• FDA’s Food Microbiology Control course (video or internet) and

• Seafood HACCP Alliance Sanitation Control Procedures Course

B. Inspection Component

Investigators who meet the training requirements for conducting seafood HACCP inspections will approach inspections by doing their own hazard analysis, evaluating HACCP plans or the controls in the absence of a plan; evaluating sanitary conditions; determining if the HACCP plan and

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FORM 2438 g (10/91) DSS update in response to FFC 6/27/2012 jac sanitation monitoring are being implemented, that corrective actions are being taken when necessary, reviewing records and citing deficiencies. If a question arises about the adequacy of the plan or its implementation, the investigator is encouraged to seek advice from the district, region, or CFSAN, or National Expert.

1. The seafood HACCP inspection should be performed consistent with the approach outlined in the Conducting Seafood Inspections Training Manual. Additionally, in circumstances outlined below, special, TECHNICAL PLAN REVIEWS of high risk products not covered by the inspection are to be conducted.

HACCP inspections should be planned for times when the firm is known to be in production. For firms producing both high and low risk potential products, the inspection should be conducted when high risk product(s) are produced. Product selections should be risk-based and target a particular higher risk product/process.

During a HACCP inspection, it is important to observe the implementation of monitoring, verification, corrective action and sanitation procedures during production. In some cases it may be necessary to contact the firm and determine their production schedule for the product of interest. Districts should use their discretion in employing this approach. If an evaluation of a previously classified OAI/VAI HACCP inspection of a particular product cannot be accomplished during a re-inspection, , the district is still obligated , at its earliest opportunity, to perform a re-inspection of that product or a product with identical CCPs covered under the same HACCP plan. The OAI/VAI classification for this product will remain open until a satisfactory inspection is conducted.

Note: For logistical reasons, it is recognized that it will be impractical to inspect most processing vessels when they are in operation. Inspections of these vessels will normally be performed when the vessel is in port and not in operation.

2. In the event an investigator arrives at a firm prepared to do a HACCP inspection and the firm is not in operation, the inspection should be rescheduled if possible. If it is not feasible to reschedule (e.g., foreign inspections, limited harvest season), an inspection that includes a complete HACCP Records Review should then be conducted and include all of the inspection components, however, information will need to be gathered by asking questions and having the firm show you what they do.

Although it isn’t the best situation, but it will still provide valuable information on the compliance of the firm. All deficiencies should still be listed on a FDA 483.During a complete HACCP records review, an investigator should have the processor walk them through the process and describe the operation. HACCP plans, monitoring records, verification documents, corrective action records, and sanitation monitoring records covering previous production days should be reviewed.

Any sanitation deficiencies or deficiencies with the HACCP plan or HACCP records observed should still be noted on the FDA Form 483.

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3. Investigators should conduct, if time allows, a technical review of HACCP plans for all products listed as “high risk potential” in Part II. 4., in addition to the standard review of the product being processed. The technical review is one that consists only of a review of the written HACCP plan to determine if appropriate/reasonable hazards and controls are identified. It is not necessary to review monitoring records or corrective action records. Any significant problems with the HACCP plan(s) should be documented and reported on the EIR and the FDA 483. A FDA Form 3501 should be completed for one product covered by each HACCP plan that has only had this technical review. However, ensure that the Question # 10 (Actively Processing) is answered

NO.

4. Document all seafood HACCP regulation and GMPs deficiencies on the Form FDA 483 in a manner consistent with the Conducting Seafood Inspections Training Course. Narrative EIRs should be completed as directed by existing instructions. Consistent with such instructions, these narrative reports should describe the firm’s HACCP control program, investigator observations, and the HACCP-related deficiencies noted during the inspection.

C. Reporting HACCP Findings – FDA 3501 (Seafood HACCP Report)

A separate seafood HACCP inspection report (FDA 3501) is to be completed electronically for the HACCP portion of the inspection for each product evaluated during a domestic or foreign inspection, including both observed processing evaluations and technical reviews.

FDA investigators are now to use the electronic version. Instructions for use of the forms are located at the top of the page. There are different links for creating forms for domestic and foreign and foreign inspections.

Contracted state inspectors are also to use the electronic version.

They can access their link for FDA 3501 through ESAF.

Please notice this special definition of actively processing that is only for the purposes of the FDA Form 3501, Question 10: “Was the firm actively processing the finished product you listed in Block 9?” - Whether a firm is to be considered as actively processing at the time of inspection depends upon the nature of the firm. If it is a warehouse and has the product listed in Block 9 being stored, the warehouse is considered to be actively processing that product. A firm that is a manufacturer, repacker, or relabeler, must be actually manufacturing, repacking or relabeling the product listed in Block 9 during the inspection it is to be classified as actively processing on the FDA Form 3501.. If a manufacturer, repacker or relabeler only has the product in inventory, it is not to be considered to be actively processing even though those activities are listed as ” processing” under 123.3(k)

It is important to fill the reports out completely and accurately. The information is entered in the National Seafood HACCP Inspection Database and used to track overall industry compliance and to develop risk rankings for products and processes. Please be very specific and

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accurate in describing the finished product and entering its product code. Accurate product codes and product descriptions are essential.

Inaccurate information can result in a misidentification of problem areas. For assistance, consult the line-by-line instructions or the FDA Product Code Builder.

D. Inspection Component(s) for Regulations other than 21 CFR 123.

It is important to remember that compliance with 21 CFR 123 is only one element of a seafood processor inspection. The investigators need to continue to apply existing skills to look for deficiencies of other regulations and statutes, such as those relating to filth, decomposition, economic fraud and other non-seafood HACCP related deficiencies. As in the past, such deficiencies will be noted on FDA Form 483 in addition to seafood HACCP deficiencies.

If an inspection is intended to cover a processor who is covered under more than one compliance program, for example a canned tuna processor, investigators should conduct the inspection in accordance with the applicable programs. It may be necessary to address each program separately during the inspection to provide adequate coverage of all the processing activities and allocation of time. The EIR should reflect this separation

For example, if part of the inspection is covered under the LACF or Acidified Foods regulations, that portion of the inspection under CP 7303.803A and the seafood processing activities not covered under those regulations would be reported under CP 7303.842.

E. Sampling

1. Seafood HACCP

The Seafood HACCP regulation was promulgated under 402(a)(4) of the Food, Drug, and Cosmetic Act. Because of that it is not necessary to routinely collect samples to support regulatory action. Work plan allocations for domestic sampling have been reduced to reflect this policy. If the firm clearly does not have controls in place, there is no need to collect a sample.

The lack of controls should be clearly stated on the FDA 483 and in the EIR. If a district thinks a sample is necessary, they should contact CFSAN prior to collecting the samples, to discuss the collection.

2. ”For Cause” Sampling

Official Samples are to be collected “for cause” only (e.g., if inspectional conditions warrant or as part of investigations of illness outbreaks or consumer complaints. Investigators should not normally collect samples for pathogen testing if HACCP controls are clearly inadequate.

In accordance with IOM 8.3.4.6.1: where vector animals or evidence thereof is present, collect samples and submit to laboratory as filth exhibits. Collection of these samples is not necessary for support of violations of 21 CFR 123.11(b), failure

DATE OF ISSUANCE: TRANSMITTAL NO: PART III PAGE 5

to monitor sanitation conditions with sufficient frequency.

For specific instructions on sample collection and shipment to analyzing labs see:

• Attachment A contains both general guidance (page 1 -

4) and specific guidance (other pages).

• Consult the current ORA Field Work Plan to determine appropriate analyzing labs.

• Prior to collecting samples for microbiological examination, please carefully review IOM sections 5.4.7.2 and 4.3.7.7 for inspectional guidance and sampling instructions, respectively, for products susceptible to contamination with pathogenic organisms.

Note that the number of samples identified in the ORA workplan is for planning purposes. Samples should be collected only if conditions warrant.

4. Documentary Samples

All documentary samples (e.g., to support interstate commerce) are to be reported only under PAC 03842. Documentary samples are NOT to use the PACs (those ending in 842H) reserved for verification samples nor are they to count towards district Workplan obligations.

F. National Marine Fisheries Service (NMFS)

FDA currently has a Memorandum of Understanding (MOU) with NMFS (Dept.

of Commerce, NOAA). The MOU sets forth the working arrangements between the two agencies to facilitate each agency's efforts to carry out its responsibilities related to the inspection of fish and fishery products. Investigators should review and follow procedures outlined in FMD#-029 (http://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectiv es/UCM278188.pdf)when conducting both domestic and foreign establishment inspections.

G. Special Instructions for Foreign Establishment Inspections

An inspection of a foreign processor who exports seafood to the United States provides a limited opportunity for FDA to evaluate compliance with the seafood HACCP regulation. These processors are chosen by CFSAN for several reasons including the products they process, their history of compliance and even the countries compliance history for certain products. A listing of products that are targeted for inspection should be provided to investigator for each firm that is to be inspected along with any refusals that FDA has had as part of the support materials prior to each inspection trip.

http://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM278188.pdf http://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM278188.pdf

DATE OF ISSUANCE: TRANSMITTAL NO: PART III PAGE 6

Investigators should follow normal investigation protocols and should focus their attention on the implementation of the HACCP program for those targeted products. If the targeted product or a product with identical hazards and controls is not being processed during the inspection, the investigator should conduct a full records review of the targeted product which includes a walk-through of the facility following the steps of production, and a sanitation inspection of the facility, and put all observations, flow charts, records reviews, etc.

in the EIR. The investigator should also conduct a seafood HACCP inspection of current processing activities, if time permits and if the product has been imported into the U. S. Investigators should not focus attention on products that are not shipped to the U.S.

It is crucial that investigators obtain documentary or photographic evidence to accompany their EIR during inspections of foreign processors. Due to the shortened time for inspection, a comprehensive review of records may need to take place at CFSAN. Investigators should obtain copies of the HACCP plans, monitoring records, corrective action records, and sanitation monitoring records.

Since most of the foreign firms inspected do not use English as their primary language, investigators should either request that the firm translate key areas of the records or plans for the investigator, or provide the investigator with translated examples. Translations should be noted on a copy of each record, if necessary, and included in the EIR. The translations obtained from the processor will help assure accuracy. A plan or records without at least partial translation are usually useless. CFSAN obtaining routine translations of the documents is cost prohibitive.

DATE OF ISSUANCE: TRANSMITTAL NO: PART IV PAGE 1

FORM FDA 2438g (7/92)

PART IV - ANALYTICAL

When sample analyses are required for cause or for HACCP Verification, use the methods referenced in the appropriate section of this Part.

• Servicing laboratories are not identified in this compliance program. Please consult the current workplan to determine the appropriate laboratory.

• As BAM and AOAC methods are updated, the most recent method should be used unless this compliance program specifically states not to use updated methods.

• Where available, NSSP methods are provided for detection of natural toxins in shellfish and are considered the preferred methods.

CHEMICAL CONTAMINANTS Project 04

For all analytical guidance, including Field Laboratories, Methodology, and Reporting, refer to Part IV of Compliance Programs Pesticides and Industrial Chemicals in Domestic and Imported Foods 7304.004 http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation /ComplianceEnforcement/ucm073186.pdf and Toxic Elements in Foods and Foodware, and Radionuclides in Foods, Domestic and Import, CP 7304.019 http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation /ComplianceEnforcement/ucm073204.pdf.

CHEMOTHERAPEUTICS

For all analytical guidance, including Field Laboratories, Methodology, and Reporting, refer to Part IV Compliance Program Chemotherapeutics in Seafood Compliance Program, CP 7304.018.

http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation /ComplianceEnforcement/ucm073192.pdf.

The sections of this part are:

A Project 03: Filth, Mold, and Foreign Objects: Microscopic/Macroscopic

B Project 03: Parasites

C Project 03: Decomposition

D Project 03: Microbiological

F Project 07: Natural Toxins

G Project 09: Food and Color Additives

H Project 21: Food Composition, Standards, Labeling and Economics http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073186.pdf http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073186.pdf http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073204.pdf http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073204.pdf http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073192.pdf http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/ucm073192.pdf

DATE OF ISSUANCE: TRANSMITTAL NO: PART IV PAGE 2

DATE AMMENDED

A. Project 03: FILTH, MOLD AND FOREIGN OBJECTS: MICROSCOPIC/MACROSCOPIC

FIELD LABORATORIES: Refer to the current ORA Field Workplan for the correct servicing laboratory.

METHODOLOGY:

AOAC, 18th Ed., Chapter 16, Extraneous Materials: Isolation

JAOAC (Interim Official First Action Methods)

FDA Laboratory Bulletin (LIB) # 3172 - Filth in Shrimp

Macroanalytical Procedures Manual (MPM)

Note: No specific analytical method exists to determine filth in Shucked Shellfish; however, depending on the type of filth suspected, adaptations of methods described in the Macroanalytical Procedures Manual (MPM) and in the AOAC, 18th Ed., are appropriate.

COMMENTS: Each subsample should be examined individually and not composited.

CONTACTS: CFSAN, Office of Food Safety, HFS-316, George Ziobro, (240- 402-1965)

REPORTING: Report all results of analytical results in FACTS using Problem Area Flag: FIL and PAC 03842B.

a. CRITERIA FOR REGULATORY ACTION:

Regulatory action may be recommended for fresh or frozen raw shrimp as a consequence of the above surveillance sampling and testing when six 2 – 3 pound subs indicates filth at or above the following levels:

• FLIES AND OTHER INSECTS (WHOLE OR EQUIVALENT)

Disease-carrying insects* - 2 in a sample;

or

Other insects - 3 of the same species in a sample.

• INSECT FRAGMENTS

Fragments from disease-carrying insects* - 5 fragments (excluding setae) present in at least 2 of 6 subs. These fragments are clearly identified as parts of a disease-carrying insect;

or

DATE OF ISSUANCE: TRANSMITTAL NO: PART IV PAGE 3

Large body parts of disease-carrying insects* (i.e., head, thorax, abdomen) - 1 in at least 2 of 6 subs.

• HAIRS

Rat or Mouse - Average of 1 per sub, any size;

or

Striated but not rat or mouse - Average of 4 per sub, any size.

The above guidance does not include all types of filth or the different combinations of filth that may be found in shrimp. Samples containing filth elements not discussed above should be submitted to CFSAN/Office of Field Programs, Division of Enforcement & Programs, Import Branch (HFS-606).

*DISEASE-CARRYING INSECTS

A disease-carrying species of insect has all of the following attributes:

1. Wild populations known to carry E. coli, Salmonella, and Shigella.

8.2 Synanthropy (a preference to live in human

settlements).

8.3 Endophily (tendency to enter buildings).

8.4 Communicative behavior (oscillating between filth

and human food).

8.5 Attraction to both human food and excrement or

other pathogen reservoirs.

8.6 Recognition by medical entomological authorities

as a disease-carrying species.

Examples include:

Flies:

Little house fly (Fannia canicularis (L.)) Latrine fly (Fannia scalaris (F.)) House fly (Musca domestica (L.)) Stable fly (Stomoxys calcitrans (L.)) Cosmopolitan blue bottle fly (Calliphora vicina (Robineau-Desvoidy)) Holarctic blue bottle fly (Calliphora vomitoria (L.)) Oriental latrine fly (Chrysomya megacephala (F.)) Blue bottle fly (Cynomyopsis cadaverina (R.-D.)) Secondary screwworm (Cochliomyia macellaria (F.)) Green bottle fly (Phaenicia sericata (Meigen)) Black blow fly (Phormia regina (Meigen)) Redtailed flesh fly (Sarcophaga haemorrhoidalis (Fallen))

DATE OF ISSUANCE: TRANSMITTAL NO: PART IV PAGE 4

Ants:

Pharaoh ant (Monomorium pharaonis (L.)) Thief ant (Solenopsis molesta (Say))

This is not necessarily a complete list of disease-carrying insects that might be found in shrimp.

DATE OF ISSUANCE: TRANSMITTAL NO: PART IV PAGE 5

B. PARASITE ANALYSIS

FIELD LABORATORIES: Refer to the current ORA Field Workplan for the correct servicing laboratory.

METHODOLOGY: Bacteriological Analytical Manual (BAM) on line at http://www.fda.gov/Food/ScienceResearch/LaboratoryMet hods/BacteriologicalAnalyticalManualBAM/ucm071468.htm Chapter 19, Parasitic Animals in Foods, II. Candling to Detect Parasites in Finfish, page 19.04 - 19.05.

1. Parasite Identification

Fix parasites as described in BAM and contact Clarke Beaudry at 240-402-2503 to determine where to send them.

Send a minimum of 3 whole parasites of each species found and all head/tail fragments found. Label vials with sample and subsample numbers and include a report form copy in the shipping container.

2. Parasite Fixation See reference in BAM, Chapter 19.

CONTACTS: CFSAN, Office of Food Safety, HFS-325, Clarke Beaudry, (240-402-2503)

REPORTING: Report all results of analytical results in FACTS using PAC 03844B and PAF “PAR”.

http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm071468.htm http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm071468.htm

DATE OF ISSUANCE: TRANSMITTAL NO: PART IV PAGE 6

FORM FDA 2438g (7/92)

DECOMPOSITION ANALYSIS

C. DECOMPOSITION ANALYSIS

FIELD LABORATORIES: Refer to the current ORA Field Workplan for the correct servicing laboratory.

METHODOLOGY: Indole:AOAC, 18th Ed., 981.07, Section 35.1.35, liquid chromatographic fluorometric method.

Histamine: AOAC, 18th Ed., 977.13, Section 35.1.32, fluorometric method

Organoleptic: Original and confirmation organoleptic analyses may only be performed by analysts qualified in the particular seafood product category as found in the agency’s “Seafood Sensory Analyst Product Category Ratings List.” This list is maintained by ORA’s Division of Field Science (HFC-140).

Products that have been treated with chemicals or additives, that have no obvious sensory indicators of decomposition or where sensory indicators may have been masked, should be chemically analyzed for decomposition where chemical indicators of decomposition are applicable. Steve Plakas or Ron Benner, CFSAN, Office of Food Safety, Division of Seafood Science and Technology, Gulf Coast Seafood Laboratory, Dauphin Island (HFS-400), 251-690-3403 or 251-690-2319, respectively, can be consulted for appropriate testing methods and applications.

REPORTING: Enter all analytical results including organoleptic results into FACTS using PAF “DEC” and PAC 03842C.

When samples are involved in an illness, in addition to notifying the Office of Emergency Operations (OEO) at 301-443-1240, contact CFSAN/Coordinated Outbreak Response and Evaluation Network (CORE), Roberta Hammond at 240-402-3035.

ANALYSIS REQUIREMENTS ARE SPECIFIC FOR PRODUCTS AS FOLLOWS:

1. SCOMBROTOXIN-FORMING SPECIES - Raw Fresh/Frozen and Processed Fish Products (To identify scombrotoxin (histamine)-forming species, consult the Fish and Fisheries Products Hazards and Controls Guidance, Table 3-2.)

a. ORGANOLEPTIC EXAMINATION

Follow the Organoleptic Method and Reporting Requirements as specified in the beginning of this section. The minimum number of subsamples to be organoleptically examined should be:

Number of Subs __to Examine__ Product Type

DATE OF ISSUANCE: TRANSMITTAL NO: PART IV PAGE 7

Raw Fresh or Fresh/Frozen 18

Processed (e.g., cooked, canned/pouched (retorted), and/or treated with chemicals or additives, including such things as salt, acid, chlorine, smoke, and carbon monoxide)

Canned/pouched tuna greater than or equal to 907 grams (2 lbs)

Note: Dried products and sauce/paste products are not included; Steve Plakas or Ron Benner, CFSAN, Office of Food Safety, Division of Seafood Science and Technology, Gulf Coast Seafood Laboratory, Dauphin Island (HFS-400), 251-690-3403 or 251-690-2319, respectively, should be consulted if decomposition analysis is indicated for dried or sauce/paste articles.

(1) Positive Findings:

When an original organoleptic analysis is performed and sensory indicators of decomposition are detected, original results should be confirmed by:

• An analyst qualified for confirmat1on analysis, i.e.

Level II (B) or III analysts, in the appropriated product category as found in the agency’s “Seafood Sensory Analyst Product Category Ratings List” maintained by ORA’s Division of Field Science (HFC- 140);

or

• Examination of an additional sample (same number of subsamples from the same production code mix as the…