Background

Definitions

Procedures

System Audits

Verification Audits

Determination of Fees and Charges

Table 1: Number of Analyses per Commodity

Table 2: Samples, Subs, and Composites Summary per Lot

Appendix A - Submission Guide & Sample HACCP Plan

Appendix B - Systems Audit Checklist

Appendix C - Systems Audit Checklist Reference

Appendix D - Minimum Criteria for Quality Assurance Systems

I. SUBJECT: Development, Assessment, Approval, and Continuing

Compliance Evaluation of HACCP-based Inspection Systems.

II. AUTHORITY: 50 CFR 260.103(c)

III. POLICY: NMFS policy is to encourage and assist interested parties in the development and implementation of HACCP-based inspection systems to facilitate consistent distribution of safe, wholesome, and properly labeled fishery products of desired uniform quality. The development and implementation of HACCP-based inspection systems is optional. However, their use should result in more efficient use of NMFS resources to inspect, grade, and certify fishery products.

IV. PURPOSE: (1) To provide guidance for the development, implementation, and operation of HACCP-based inspection systems which will meet NMFS approval, and (2) to establish procedures for use by USDC inspectors to ensure uniformity in the evaluation of the completeness and effectiveness of the system.

V. GENERAL: In July 1992, NMFS published a Federal Register notice announcing the availability of a new seafood inspection program based on Hazard Analysis Critical Control Point (HACCP) principles. This program is a refinement of the Integrated Quality Assurance (IQA) Program that also uses HACCP principles. However, the IQA program, having unique methods for the inspection and grading of products, will continue as an option for applicants to the program.

Background

HACCP, is a non-traditional, non-continuous inspection technique recommended by the National Academy of Sciences as a more scientific, analytical, and economical approach than that provided by traditional inspection and quality control methods. HACCP, which focuses on problem prevention and problem solving, relies heavily on proper monitoring and record keeping by the industry. One of the primary economic benefits of HACCP is that it provides for reduced destructive sampling of the finished product as compared to the end-product sampling required under traditional inspection systems, including the current NMFS Integrated Quality Assurance program.

In addition, the application of HACCP principles to seafood inspection has been adopted by several countries, including Canada, Iceland, and Thailand, and is becoming more broadly recognized by the international community as a mechanism to apply uniform inspection procedures.

Industry and NMFS Benefits

The HACCP-based inspection program will allow participants an opportunity to apply their existing quality control systems more efficiently, receive the management benefits of producing safe, wholesome, and properly labeled products more consistently and obtain the marketing benefits of using marks associated with the program. It will also allow for more efficient use of NMFS resources. The new program is structured so that NMFS inspection frequencies can be varied depending on an individual facility's compliance history. That is, firms that demonstrate the ability to maintain consistent control can be inspected less frequently.

In summary, the HACCP-based service is consistent with global activities to harmonize inspection protocols. In addition, NMFS believes that the HACCP-based service will enhance the safety, wholesomeness, and economic integrity of seafood available to consumers, as well as improve seafood industry quality assurance and regulatory oversight.

VI. DEFINITIONS:

A. Control Point: Any step in a process whereby biological, chemical, or physical factors may be controlled.

B. Corrective Actions: Procedures to be followed when a serious or critical deficiency is assessed or when a critical limit is reached or exceeded.

C. Critical Control Point (CCP): Any step in a process which, if not properly controlled, may result in an unacceptable safety, wholesomeness, or economic fraud risk.

D. Critical Deficiency: A hazardous deviation from plan requirements such that maintenance of the safety, wholesomeness, and economic integrity is absent; will result in unsafe, unwholesome, or misbranded product.

E. Critical Limit: An established point which must not be exceeded if a hazard is to be controlled at a CCP.

F. HACCP Plan: A document that describes the firm's HACCP-based inspection system.

G. Hazard: A chance for, or the risk of, a biological, chemical, physical, or economic property in a food product that could violate established program criteria or cause the consumer distress or illness.

H. Low risk products: Seafood that poses no significant risk to the health of the public when prepared for consumption by conventional or traditional means.

I. Major Deficiency: A significant deviation from plan requirements, such that maintenance of safety, wholesomeness, or economic integrity is inhibited.

J. Minor Deficiency: A failure of the part of the HACCP-based system relative to facility's sanitation which is not likely to reduce materially the facility's ability to meet acceptable sanitation requirements.

K. Monitoring Procedures: Scheduled testing and/or observations recorded by the firm to report the findings at each CCP.

L. Preventive Measure(s): Any action that will inhibit the introduction of hazards into the product.

M. Process: One or more actions or operations to harvest, produce, store, handle, distribute, or sell a product or group of similar products.

N. Serious Deficiency: A severe deviation from plan requirements such that maintenance of safety, wholesomeness, and economic integrity is prevented; and, if the situation is allowed to continue, may result in unsafe, unwholesome, or misbranded product.

O. Substantial risk products: Seafood that may pose a significant danger to the health of the public when prepared for consumption by conventional or traditional means. For example, ready-to-eat; heat and/or brown and serve products; products which may contain a microbial pathogen, biotoxin, or physical or chemical contaminant which may pose an unacceptable health risk at the time of consumption.

P. Systems Audit: On-site NMFS evaluation of the firm's effectiveness in following the plan after validation.

Q. Validation: On-site NMFS evaluation of the plant's completeness and workability, and the firm's effectiveness in following the plan.

R. Verification: Periodic review by the firm to determine the overall effectiveness of the HACCP plan.

S. Verification Audit: Unannounced on-site NMFS review of the effectiveness of NMFS field inspection personnel in following established procedures.

VII. PROCEDURES:

A. Application:

1. Firms who wish to participate in the Program may apply orally or in writing to the appropriate Regional Inspection Branch. If application is made orally, it must be confirmed promptly in writing.
2. Once an application is received by the Regional Inspection Branch, it is forwarded to the Regional HACCP Activities Coordinator for action.
3. The Regional HACCP Activities Coordinator will provide the applicant with all necessary materials to inform them of the program and its requirements. This material will also include the requirements for development and submission of a HACCP Plan.
4. The Regional HACCP Activities Coordinator will complete a Record of Contact for this activity and forward it to Division Headquarters for entry into the tracking system.
5. The firm develops its HACCP Plan and submits it for review according to the HACCP Plan Review Procedures below.

NOTE: Firms who wish to have a more in-depth presentation of the Program and its requirements may request a meeting of all interested parties. This may incur a cost for travel and should be discussed with the appropriate Regional Inspection Branch.

B. Development of HACCP Plans. Each applicant must submit a HACCP plan in accordance with the attached Submission Guide (Appendix A).

NOTE: At the request of the firm, NMFS will provide consultation toward the development of the HACCP plan on a fee basis (See paragraph IX.).

All processes included in the HACCP Plan must include the following elements. More detail can be found in the attached Submission Guide (Appendix A).

1. Organization Chart and Narrative: A diagram identifying the personnel responsible for the development, implementation, and maintenance of the plan; and narrative describing the duties of the identified personnel.
2. Description of Fishery Products: A list of all major groups of finished fishery products that are to be covered by the HACCP-based Inspection Program.
3. Process Flow Charts: A diagram(s) illustrating the operational steps involved with a product or similar products.
4. Critical Control Point Worksheet: A description of the following information for each CCP.

a) Location of the Critical Control Point

b) Hazards to be controlled at that Critical Control Point

c) Preventive Measures

d) Critical Limits

e) Monitoring Procedures

f) Corrective Actions

g) Records

5. Record Keeping System: A method to identify, describe, and locate the records associated with the plan. All plan records must be maintained by the firm for a period of six months beyond the expected shelf life of the product and be accessible at all times to NMFS inspection personnel.

6. Verification Procedures: A description of the methods the firm will use to determine the overall effectiveness of the HACCP plan.

7. Sanitation Standard Operating Procedures: A comprehensive description of the firm's program to ensure sanitation compliance.

8. Consumer Complaint File: A procedure for handling, addressing, and filing consumer complaints.

9. Recall Procedures: A method for identifying, locating, and retrieving products.

NOTE: Although not required, NMFS recommends that the firm'submit end-item verification records (as described in paragraph VII.E) with their HACCP Plan. This will allow the firm to test their controls, provide plan reviewers more information, and possibly reduce the Validation cost.

C. HACCP Plan Review and Approval: Submission and review of HACCP Plans will be handled using the following procedures:

1. Plans are submitted to the Regional HACCP Activities Coordinator.
2. The Regional HACCP Activities Coordinator, through Region management, assigns the plan to a qualified Consumer Safety Officer for initial review.
3. The assigned Consumer Safety Officer reviews the plan and requests changes, clarifications, deletions, etc., from the firm. In this activity, the assigned officer works with the firm to finalize the development of the HACCP Plan.
4. Once the assigned officer is assured the firm's HACCP Plan is complete, it is forwarded to the Regional HACCP Activities Coordinator. Included with the HACCP Plan is an outline of the activities of the reviewer which describes the controversies encountered and the decisions, if any, that were agreed to between the reviewer and the firm.
5. The Regional HACCP Activities Coordinator reviews the HACCP Plan for completeness and workability. A written review is sent to the firm indicating what changes, if any, are necessary prior to Validation.
6. Once it is decided by the Regional HACCP Activities Coordinator that the HACCP Plan is ready for Validation, it is forwarded to Field Operations Headquarters, National HACCP Activities Coordinator for final review. A complete description of all work by both the assigned Consumer Safety Officer and the Regional HACCP Activities Coordinator accompanies the HACCP Plan.
7. Field Operations performs a final review of the HACCP Plan ascertaining complete work by the Region. When the plan review is complete, Field Operations informs the Region as to approval/disapproval of the HACCP Plan and, if applicable, requests the Region to schedule the Validation with the firm.
8. All work of the assigned CSO and Regional HACCP Activities Coordinator is performed on a fee basis according to the Schedule. All time and charges are logged by all parties involved in their personal logs and a Daily Record of Charges is completed.
9. Modifications to the HACCP Plan: After the HACCP plan has been validated, modifications may be made under the following conditions:

a. The firm must notify NMFS, in writing (Faxes are acceptable), of any modifications in their HACCP plan before implementing the changes.

b. Any changes made to the plan due to unusual circumstances, such as to address a health or safety issue, must be documented in a corrective action plan.

c. The NMFS Regional Inspection Branch must be notified of these immediate changes within one working day.

D. Label Review Procedures:

1. All applicable labels must be approved prior to use in accordance with Part I, Chapter 3, Section 5 of NOAA Handbook 25, Inspection Manual except as listed below. (Labels previously submitted and approved under other existing NMFS Inspection Programs need not be resubmitted for approval)
2. Labels will be submitted to the HACCP Activities Coordinator for review. With respect to the HACCP-based Inspection Program only, the firm's HACCP Plan will act as the required specification for label review.
3. The HACCP Activities Coordinator will forward these labels for approval to a qualified Consumer Safety Officer. Once completed the HACCP Activities Coordinator will combine the review of labels with the plan review and forward all to the facility.
4. If a firm believes it is competent to review its own labels, the following procedures apply:

a. A sample of the labels of products covered in the firm's HACCP Plan will be submitted to the Consumer Safety Officer assigned to review the firm's HACCP Plan.

b. The sample size will consist of a minimum of six labels and a maximum of ten (10) percent of the firm's total applicable labels. At least one label for each identified process will be submitted.

c. The labels will be reviewed for accuracy and compliance. Preliminary reviews (general compliance to Part I, Chapter 3, Section 5, NOAA Handbook 25) will be conducted by the assigned Consumer Safety Officer, or other qualified field personnel. More specific and final reviews for compliance will be sent to the Label Approval Officer, Document Approval and Supply Services, Pascagoula, MS.

d. If after this review it is determined that the firm has control of the labeling requirements associated with its products (legal and programmatic), then the firm will be allowed to produce products under the HACCP Plan without routine NMFS label pre-approval.

e. If a firm is granted pre-approval authority for its labels, five copies of each label of products covered by the firm's HACCP Plan must be submitted to the Label Approval Officer, Document Approval and Supply Services, Pascagoula, MS.

f. These copies must be submitted within sixty (60) days of first use by the firm.

g. In addition, each label used by the firm will be considered a part of the records of the HACCP Plan and will be treated as such. Demonstrated failure of the firm to adhere to their responsibilities in this area will be considered a failure of the HACCP Plan and the firm will be assessed a deviation in the appropriate place on the Systems Audit Checklist. Failure will also result in the immediate suspension of this policy and the firm will be required to submit labels for approval prior to their use.

NOTE: Product labels bearing a Child Nutrition Statement must be approved prior to use in accordance with USDA requirements. There will be no exceptions.

E. Pre-Validation: Prior to Validation of the firm's HACCP Plan, the firm must operate using the plan for a specified time period. This will provide the Validation team with necessary information regarding the firm's ability to follow their own written procedures. To prepare for the Validation, the firm must follow the following procedures:

1. The firm'should begin following their plan as soon as possible.
2. The firm will adhere to the plan's provisions and keep all records associated with the approved HACCP plan for at least 10 consecutive production days.
3. The firm will contact the Regional Inspection Branch as soon as they believe the approved plan is functioning successfully and when they have records covering at least ten (10) consecutive production days.
4. The Regional Inspection Branch will schedule a Validation inspection with the firm. Once the Validation is scheduled the Regional Inspection Branch informs Field Operations of its date and location as well as all parties who will attend from NMFS.
5. The firm must verify through end-product examination that the process controls result in complying product. If documentation has not been previously provided, the firm must collect data during the pre-validation period which will be sufficient to demonstrate this relationship. Firms attempting to document this relationship during the pre-validation period must collect data on not less than 20 percent of their lots using sampling plans comparable to those in 50 CFR Part 260, with at least one lot representing each product form. The inspection records must be available to NMFS at the validation.

F. Validation:

The Validation will determine whether all of the hazards and CCPs have been identified, the plan is being followed and monitored by the firm, and is effectively controlling the identified hazards. Procedures for Validation are as follows:

1. The Validation will be conducted on a fee basis (See paragraph IX.) by a team of no more than three NMFS officials. The number and structure of the team will be determined by the size and complexity of the firm's process and nature of hazards associated with the products covered under the HACCP Plan.
2. The Validation team will have an assigned Consumer Safety Officer as lead who will have final authority of the facility's firm's rating based on the teams findings.
3. Validation includes conducting paperwork reviews, recording sanitation and in-process observations and inspecting samples of finished product. All reviews will be performed using accepted auditing practices.
4. Product evaluations will be completed by conducting a combination of statistical reviews of records and finished product sample inspections. At least one lot for each product form will be evaluated by inspecting samples of finished product. NMFS inspection personnel may, for cause, sample and inspect lots in excess of this guideline. Results will be recorded on the appropriate score sheet(s).
5. Firms will be rated using the appropriate Systems Audit Checklist. If the firm receives a Level IV rating or higher it will qualify as a participant in the program and may finalize a contract for services with NMFS.
6. Only with a valid contract and continued demonstrated compliance with all applicable laws and regulations and policies may 1) the firm be eligible to use official marks or other related statements and 2) firm-collected data be used by NMFS towards issuing official certification of the firm's products or facility compliance.
7. To build a compliance history, all firms will enter the program at Level IV. The results of subsequent Systems Audits, as described in Section G, will allow changes in the facility rating.
8. If a firm passes its Validation, all products under review during the Validation, including the previous ten (10) production days, are eligible to bear the appropriate official marks or advertising claim.

NOTE FOR VESSELS: Due to logistical factors, only one NMFS Consumer Safety Officer will perform the Validation. In addition, the pre-validation and validation periods may be combined. The NMFS Consumer Safety Officer will accompany the vessel for an appropriate time period during a fishing season, performing the background checks of critical control points and validating the plan at one time. The officer may assist the quality assurance/management group on board the vessel in any alterations to make to their HACCP Plan to work toward plan approval and a successful Validation. Once the HACCP plan is validated, the officer is taken off the vessel as soon as is practicable. These procedural accommodations are made in recognition of possible space restrictions and to reduce the numbers of transfers at sea.

G. Systems Audits:

1. VESSELS:

a. After the firm's HACCP Plan is validated, NMFS will conduct Systems Audits, at the frequency described below, to determine the firm’s continued adherence to their HACCP Plan:

* An on-board Systems Audit for facilities at these Levels shall be conducted on a frequency of not less than annually.

b. Firms must provide the appropriate NMFS Regional Inspection Branch with all necessary season schedules and off-loading schedules and sites as soon as they are known. Firms must give the Port NMFS Consumer Safety Officer a minimum of 24 hours notice of port arrival.

c. A visit will be composed of a minimum of one, to a maximum of ten (10) percent of, the scheduled fishing days for the trip in question. For example, if a trip is scheduled to last 30 days, the Systems Audit will be performed over approximately three days. Additional days may be necessary if the Consumer Safety Officer has encountered a problem during the audit.

d. A firm may move to the next higher rating after completing the above number of successive Systems Audits. A firm will move to a lower Level if one Systems Audit results in a rating that is lower than the current Level held by the firm. For example, a firm at Level III will have to complete 2 successive Systems Audits with a rating of Level II or higher in order to move up to the audit frequency of Level II. Conversely, a firm that is currently at Level I will move down to Level IV if any Systems Audit results in a rating of Level IV.

e. The results of each Systems Audit will determine the firm’s next rating and are based upon the findings as recorded on the appropriate Systems Audit Checklist.

f. The NMFS Consumer Safety Officer will complete the Systems Audit Checklist in accordance with the instructions in Appendix B and Appendix C. The information recorded on the checklist will indicate to the NMFS Consumer Safety Officer and the firm how well the plan is being followed.

g. To determine whether the product meets specification and/or U.S. grade standard requirements, NMFS will audit a percentage of the total lots produced by the firm since the last Systems Audit, as follows:

h. Product verifications will be completed by conducting records reviews and finished product sample inspections. Lots must be defined by the firm in their HACCP plan and approved by NMFS.

NOTE: Samples of finished product may be pulled while the NMFS Consumer Safety Officer is on board or at dockside. If samples are pulled while on board, they will be evaluated immediately for compliance.

i. A minimum of five (5) lots (or the above percentage, whichever is greater), and a maximum of fifty (50) lots will be evaluated by records reviews.

j. In addition to the records reviews, at least one lot and up to 50 percent of the lots selected for records review will be selected for product verification and evaluated by inspecting samples of finished product.

k. The results of each finished product inspection will be recorded on the applicable score sheet(s). All score sheets will be attached to the Systems Audit Checklist.

2. PROCESSING ESTABLISHMENTS:

a. NMFS will conduct unannounced Systems Audits, at the frequency identified below, to determine the firm’s continued adherence to their plan.

b. The results of each Systems Audit will determine the firm's next rating and are based upon the findings as recorded on the appropriate Systems Audit Checklist.

c. A firm may move to the next higher rating after completing the above number of successive Systems Audits that resulted in a higher rating than currently held by the firm.

d. A firm will move to a lower Level if one Systems Audit results in a rating that is lower than the current Level held by the firm. For example, a firm at Level III will have to complete 2 successive Systems Audits with a rating of Level II or higher in order to move up to the audit frequency of Level II. Conversely, a firm that is currently at Level I will move down to Level IV if any Systems Audit results in a rating of Level IV.

e. The NMFS Consumer Safety Officer will complete the Systems Audit Checklist in accordance with the instructions in Appendix B and Appendix C. The information recorded on the checklist will indicate to the NMFS Consumer Safety Officer and the firm how well the plan is being followed.

f. To determine whether the product meets specification and/or U.S. grade standard requirements, NMFS will audit a percentage of the total lots produced by the firm since the last Systems Audit, as follows.

g. Product verifications will be completed by conducting records reviews and finished product sample inspections. Lots must be defined by the firm in their HACCP plan and approved by NMFS.

h. A minimum of five (5) lots (or the above percentage, whichever is greater), and a maximum of fifty (50) lots will be evaluated by records reviews.

i. In addition to the records reviews, at least one lot and up to 50 percent of the lots selected for records review will be selected for product verification and evaluated by inspecting samples of finished product.

j. The results of each finished product inspection will be recorded on the applicable score sheet(s). All score sheets will be attached to the Systems Audit Checklist.

3. RETAIL AND FOOD SERVICE ESTABLISHMENTS:

a. NMFS will conduct unannounced Systems Audits, at the frequency identified below, to determine the firm's continued adherence to their plan.

b. The results of each Systems Audit will determine the firm’s next rating and are based upon the findings as recorded on the appropriate Systems Audit Checklist.

c. A firm may move to the next higher rating after completing the above number of successive Systems Audits that resulted in a higher rating than currently held by the firm.

d. A firm will move to a lower Level if one Systems Audit results in a rating that is lower than the current Level held by the firm. For example, a firm at Level III will have to complete 2 successive Systems Audits with a rating of Level II or higher in order to move up to the audit frequency of Level II. Conversely, a firm that is currently at Level I will move down to Level IV if any Systems Audit results in a rating of Level IV.

e. The NMFS Consumer Safety Officer will complete the Systems Audit Checklist in accordance with the instructions in Appendix B and Appendix C. The information recorded on the checklist will indicate to the NMFS Consumer Safety Officer and the firm how well the plan is being followed.

f. To determine whether the product meets specification and/or U.S. grade standard requirements, NMFS will audit a percentage of the total lots produced by the firm since the last Systems Audit, as follows.

g. Product verifications will be completed by conducting records reviews and finished product sample inspections. Lots must be defined by the firm in their HACCP plan and approved by NMFS.

NOTE: NMFS is interested in providing this program with a minimum possible burden to participants. Record keeping should not be so grand as to cause undue hardship on the retailer. Records should be of a precision only to show what products were received by what supplier on a particular day.

h. A minimum of five (5) lots (or the above percentage, whichever is greater), and a maximum of fifty (50) lots will be evaluated by records reviews.

i. In addition to the records reviews, at least one lot and up to 50 percent of the lots selected for records review will be selected for product verification and evaluated by inspecting samples of finished product.

j. The results of each finished product inspection will be recorded on the applicable score sheet(s). All score sheets will be attached to the Systems Audit Checklist.

k. Procedures for Chains with an Established Quality Assurance Program:

1) Firms which operate a chain of stores may have the stores under the program sampled at the frequency outlined below (provided they have an established approved Quality Assurance System):

In addition the following criteria apply:

Reduced 80% of the stores sampled must be at Level II or higher with a minimum of 5% at Level I. No stores in the sample may be at Level IV.

Normal 90% of the stores sampled must be at Level III or higher with no stores in the sample at Level IV.

2) All firms will begin at the Tightened level. After two successful calendar quarter at this level the firm may move up to the Normal level.

3) If the firm remains at the Tightened level for three calendar quarters, the firm will be subject to store by store auditing for a period of six months. After six months the firm may reapply for this sampling system under their quality assurance program.

4) The firm must achieve the Reduced level of compliance while at the Normal level for two calendar quarters in a three calendar quarter period in order to move to the Reduced level of auditing.

5) No stores in the sample will be permitted to fall to Level V. If a store in the sample falls to Level V, the Firm’s Quality Assurance System is suspect. NMFS will perform an audit on the total Quality Assurance System for the next thirty days. This audit will include the sampling of additional stores.

6) If after the audit the Quality Assurance System is deemed under control, the firm will be sampled at the Tightened level and the system begins again.

7) If the Quality Assurance System is deemed to not be performing as designed, all stores will be subject to inspection for the next six months. After that time, the firm may reapply for NMFS acceptance of the Quality Assurance System.

8) During this thirty day period the stores may continue to use all advertisement claims.

9) NMFS will evaluate the Quality Assurance Systems using the guidelines listed in Appendix D.

10) If the sample of stores does not meet the above requirements, then each store in the chain must be audited on its own until such time as the Quality Assurance System has been re-approved.

H. Laboratory Analyses Procedures:

1. Sample Selection

a. The Consumer Safety Officer must select, inspect condition of product, pack, and dispatch the sample. Plant personnel are NOT to handle the sample. The sampling process must be conducted in compliance with the National Marine Fisheries Service and the National Seafood Inspection Laboratory guidelines and procedures as identified in Tables 1 and 2.

b. The appropriate number of sample units must be removed for laboratory analysis from each lot according to the information contained in the body and footnotes of Tables 1 and 2. After the samples are removed, the Consumer Safety Officer must indicate on each sample bag with a "permanent marker" the following information: subsample number; sample description (commodity or product); lot or code number; subsample numbers per lot; quantity; size and weight; and date and time. The list of instructions and table for each type of sampling is furnished as Appendices 1-4.

c. The NMFS Consumer Safety Officer will select samples for laboratory analyses in accordance with Tables 1 and 2 or for cause. Where several product forms (e.g., cooked shrimp, cooked spiced shrimp, and cooked breaded shrimp, cooked crawfish, cooked lobsters, and cooked snow crabs) are produced under a single approved HACCP Plan, these are considered as one commodity. Sampling requirements for laboratory analyses apply to the commodity in this context, not to individual products or product forms (examples are stuffed trout or stuffed flounder, fish sticks or fish portions, cooked shrimp of different sizes or in different packages). In some cases multiple analyses can be conducted from a single set of subsamples.

2. Identifying and Documenting Samples

a. The Consumer Safety Officer must complete the Sample Submission Sheet with the required sample and subsample information for the samples being shipped. The sheet must contain the following information:

1) Date Submitted

2) Company - Name/Owner

Address and Phone Number

3) Consumer Safety Officer Name

4) Consumer Safety Officer Number

5) Consumer Safety Officer Phone Number

6) Date Collected

7) Time Collected

8) Product Code/Brand

9) Type of Analysis Requested

10) Sample Number

11) Type of Product Commodity

12) Lot or Code Number

13) Lot Size

14) Unit Size or Weight

15) Units Submitted

16) Other Information - When available provide the following information if possible:

a) Condition of raw material(s)

b) Condition of finished product.

c) Age of raw materials at time of production.

d) Length of time raw material held in storage.

e) Length of time finished product held in storage.

f) Storage temperature.

g) Raw material storage condition.

h) Finished product storage conditions.

i) Condition of production equipment.

j) Any additional information that will help in the analysis.

k) Species and country of origin.

3. Sample Shipment

a. The Consumer Safety Officer must use a leak-proof, insulated container for shipping fresh or frozen seafood product samples. It should be as light weight as possible to minimize shipping costs, yet sturdy enough to maintain the integrity of its contents during handling and shipping by common carriers. Containers for non-perishable samples, i.e., samples not requiring refrigeration, must be sturdy enough to retain the samples in their original condition.

1) Fresh Perishable Samples -- All samples of fresh perishable products will be packed with frozen gel packs in sufficient quantity to maintain the product at a temperature not to exceed 38 degrees F for at least three days. The container will be marked "Perishable Product."

2) Frozen Samples -- All samples of frozen products will be packed with sufficient frozen gel packs to maintain the product in a frozen state for at least three days. The container will be marked "Perishable Product."

3) Non-Perishable Samples -- Canned products shall be packed in a sturdy container acceptable by common carrier.

4) Dry Ingredient Samples -- Dry products shall be placed in a plastic bag, preferably of the whirl-a-bag type. Samples submitted for pesticide or other chemical tests should be placed in clean glass containers.

5) Time of shipment - Perishable samples must be shipped no later than Wednesday by overnight delivery to assure arrival no later than Thursday, 10:30 am.

6) The Consumer Safety Officer will also complete a Government Bill of Lading (GBL) as needed.

7) Shipments by overnight mail will be consigned to:

F/TS41 - Laboratory Director

C/O Sample Custodian

DOC/NOAA/NMFS

National Seafood Inspection Laboratory

3209 Frederic Street

Pascagoula, MS 39567

(601) 762-7402

I. Verification Audits:

1. NMFS will be responsible for verifying that the HACCP-based Inspection Program is functioning in accordance with established procedures.
2. The Verification Audits will be performed by a team which may include individuals from NMFS Inspection Headquarters, Regional Inspection Branch, and the NMFS National Seafood Inspection Laboratory.
3. Verification Audits will be performed at the following frequencies based on the risk of the product(s):

Substantial Risk products: at least once every two years unless the firm is rated below Level IV.

Low Risk products: at least once every two years for the first four years the firm is in the Program. Verification Audits will then be performed every four years as long as the firm does not drop below Level IV in those four years.

4. A Consumer Safety Officer from the Regional Inspection Branch will be present during all Verification Audits and will conduct a Systems Audit.

5. The Verification Team will also conduct a Systems Audit to compare with the Regional Inspector's results.

6. Any differences in the results of the Verification Team's results and the inspector's results will be discussed.

7. The rating identified by the Verification Team will be the final rating of the firm for that visit.

J. Procedures for Firms Which Fall Below Level IV: A firm rated at Level V has demonstrated difficulties in administering their HACCP Plan. Firms which fall to Level V at any time will be subject to the following procedures:

1. If a Consumer Safety Officer believes that a facility has fallen to Level V rating, he/she will contact the Regional HACCP Activities Coordinator and the officers Supervisor.
2. The three together will decide whether or not to recommend that the facility should drop to Level V. If so, the Regional HACCP Activities Coordinator will contact the National HACCP Activities Coordinator.
3. The Regional HACCP Activities Coordinator will FAX all necessary information to the National HACCP Activities Coordinator and then contact him/her by telephone. Present on the call will be the appropriate Supervisory CSO, the Regional HACCP Activities Coordinator, and the auditing CSO.
4. Once all information is received by the National HACCP Activities Coordinator, a decision will be made by the Inspection Services Division Management. The decision will be communicated to the Regional HACCP Activities Coordinator as soon as it is made. A written report will follow.
5. The decision to drop a facility to Level V will be made prior to the Consumer Safety Officer performing the exit interview.
6. Facilities who fall to Level V have a period of thirty days to obtain a rating of Level IV or higher. Failure to do so will result in the facility’s removal from the NMFS HACCP-based Inspection Program.
7. A firm who falls to Level V may continue to use the mark or other advertising privileges if consent by NMFS is given for daily auditing of the firm. Consent will be on a case by case basis and granted only if NMFS believes the nature of the condition which caused the firm to fall to Level V warrants daily auditing. Daily auditing will be acceptable to NMFS under the following conditions:

a. The firm must submit a corrective action plan to the NMFS Consumer Safety Officer detailing how they will correct the problem and obtain a Level IV (Faxes are acceptable). The corrective action plan must include, at a minimum, detailed descriptions of the following:

1) A statement of the problem

2) Identification of the person or persons handling the situation

3) The methods to be used to correct the problem

4) A schedule which details the time frame to correct the problem

5) A statement with signatures of top management attesting to their commitment to correct the deficiency

The corrective action plan must be written in sufficient detail to provide NMFS with all necessary information for its approval or disapproval.

b. The NMFS Consumer Safety Officer will review the corrective actions identified by the firm and send a copy to the Regional Inspection Branch and NMFS Headquarters.

c. NMFS Headquarters will approve or disapprove the corrective actions and notify the Regional Inspection Branch who will contact the firm. At this time, NMFS will discuss with the firm how long they must remain on daily auditing. In any case, daily auditing will be granted for only thirty calendar days.

d. Products may be certified during daily auditing. However, if any condition(s) exists that is considered critical, no product certification will occur until the condition is corrected to the satisfaction of NMFS.

e. At the inspector's discretion, product compliance will be verified by end-item inspection. No products covered by the HACCP plan will leave the firm without NMFS approval.

f. The firm must obtain a Level IV rating within thirty calendar days or be dropped from the HACCP-based Inspection Program.

g. Firms that drop to Level V rating twice in a twelve month period will be removed from the HACCP-based Inspection Program.

h. Firms who have been dropped from the HACCP-based Inspection Program may submit a request for reapplication into the program after a period of three calendar months. Application will be accepted by NMFS only if evidence of a change in management philosophy can be provided.

i. Firms who have been dropped from the NMFS HACCP-based Inspection Program may still be eligible to enter into the traditional Inspection Program.

K. Additional Requirements

1. Employment of Certified HACCP-based Inspection Person(s):

a. Each facility must employ a NMFS-certified person knowledgeable in the HACCP program's principles to be present during all processing times.

b. The certification must be kept on file and available to NMFS at all times.

2. Verification Procedures.

a. Periodic end-item verification of product compliance to program requirements must be performed by the firm. Frequencies and end-item requirements must be agreed upon by both the firm and NMFS.

b. In addition samples for analytical testing must be collected and tested at least once per year as part of their verification procedures. The level of analytical sampling per lot must be comparable to that found in Tables 1 and 2.

c. Records of all analytical findings will be made available to NMFS inspectors during Systems Audits and at other times as necessary.

3. Use of Marks. Participating firms are responsible for using the marks in accordance with the regulations set forth in 50 CFR Part 260 and the Policy and Guidelines for Advertising and Marking Products Inspected by the U.S. Department of Commerce.

VIII. Reporting and Documentation Control:

A. HACCP Plans:

1. HACCP Plans will be kept secured by the appropriate Regional HACCP Activities Coordinator.
2. Copies of the HACCP Plan may be made under the following conditions:

a. Each page of each copy must be stamped "Confidential" in red ink.

b. The copies must be numbered.

c. A log will be kept by the HACCP Activities Coordinator of which authorized individuals have checked out the HACCP Plan copy, the date of check out, and the date of return.

3. No unauthorized persons may receive a copy of the HACCP Plan.

B. Systems Audit Reporting:

1. The completed Systems Audit Report (working papers, narrative, Systems Audit Checklist, and supporting documentation) will be sent to the Regional HACCP Activities Coordinator by the assigned Consumer Safety Officer.
2. A copy of the Systems Audit Report (without the working papers) will be sent to the Supervisor of the assigned Consumer Safety Officer.
3. A copy of the Systems Audit Checklist will be given to the firm prior to exiting.
4. The Regional HACCP Activities Coordinator will complete a memorandum to the chief officer of the firm listing the serious and critical deficiencies, as well as positive results, found during the Systems Audit Checklist.
5. One copy of this memorandum will be forwarded to the Regional Inspection Branch Office.

IX. Determination of Fees and Charges. The fees and charges for the HACCP-based Inspection Program are established, assessed, and collected in accordance with the regulations set forth in 50 CFR Part 260. The fees and charges may be adjusted as necessary to recover costs. The current hourly fees for the services and laboratory costs for various analyses shall apply. Travel expenses associated with the HACCP-based Inspection Program are billed separately.

Since the costs associated with the HACCP-based Inspection Program are specific to each facility, NMFS will discuss fully the details of the costs with each applicant before any contractual arrangements are made.

A. HACCP Plan Development. At the request of the firm, NMFS will provide consultation for plan development, charged at the existing Type III rate for consultative services.

B. HACCP Plan Review. NMFS review of the final HACCP plan will be charged as a flat fee based on the current Type III rate for consultative services. The fee determination for HACCP plan review is as follows:

1. Type III rate x 8 hours, for the first process
2. Type III rate x 5 hours, for each process thereafter.

In the event that NMFS suggests changes to the HACCP plan, subsequent reviews will be charged based on actual review time at the current Type III rate.

C. Validation. The validation is charged at the current Type III rate, plus travel and laboratory costs, where necessary. The total cost of a validation inspection will vary depending on such factors as the size of the firm, the number and complexity of the processes covered under the HACCP plan, the risks associated with the products involved, and the completeness of the presented plan.

D. Systems Audits. After contract implementation, the fees for the HACCP-based service will be charged at the current Type I rate for in-plant inspection services, with additional charges for travel and analytical tests, where appropriate, at the current specific charge for each test. The fees for any services provided on an overtime basis or on Sunday or legal holidays will be charged at the current overtime or Sunday/holiday rates.

Appendix A

I. Introduction

This guide is designed to provide the reader with a method of developing their HACCP plan. It provides the format that must be followed as well as brief discussions on each important point in the HACCP plan. Also included in the guide is an example of a complete HACCP plan. The reader is encouraged to refer to this example when reading the guidance.

The plan must be submitted in the following format:

1. Organization Chart
2. Organization Chart Narrative
3. Description of Fishery Products
4. For Each Discrete Product Form:

a. Process Flow Chart

b. For Each Critical Control Point:

1) Location

2) Hazard/Defects to be Controlled

3) Preventive Measures

4) Critical Limits

5) Monitoring Procedures

6) Corrective Actions

7) Record Names

c. A copy of all forms associated with each Critical Control Point

5. Record Keeping Procedures

6. Verification Procedures

7. Sanitation Standard Operating Procedures

8. Recall Procedures

9. Consumer Complaint Procedures

10. Labels/Specifications

II. Organization Charts and Narrative

The facility must prepare an organization chart demonstrating the managerial responsibility of the firm. This chart must show a chain of command within the management of the facility. The facility must identify the organization of facility management to illustrate how the HACCP-based system fits into the firm's organization. The facility must also identify how the HACCP-based principles, directives, and strategies are exercised in the day-to-day operation of the facility. The relationship between the position(s) responsible for the HACCP-based system and the production manager(s) must be indicated.

The narrative should explain how each position relates to the HACCP-based system, its day-to-day operation, and the relation to the other positions on the chart.

III. Description of Fishery Products

A description of the finished product (e.g., product form) must be developed in order to prepare a systematic evaluation of the hazards and associated risks in a specific food and its ingredients or components. Some examples follow:

IV. Process Flow Charts

To assist the facility in developing a HACCP plan, a flow chart depicting the operational steps of how the fishery product (e.g., raw fish, cooked crabmeat, surimi, etc.) is handled throughout the facility must be made. The chart must show the steps in numerical order from when the firm takes control of the product until the firm releases control of the product. For example:

These operational steps are the control points for your process. A process is defined as "one or more actions or operations to harvest, produce, store, handle, distribute, or sell a product or group of similar products." The company may design any type flow chart for their process that is easy to follow and represents their process. An example is found on page 17 of this document. Other examples of flow charts for various product forms may be obtained through your Regional NMFS Inspection Branch.

V. Critical Control Point Worksheet

Note: Thermal processes used in the facility must have been established by a qualified person(s) having expert knowledge acquired by appropriate training and experience in the processing of the product. Any critical limits designated by the person(s) will be in writing and will be used in the monitoring of the processing step.

A. Identification of Hazards Associated with Each Step

For each control point identified on the flow chart, an assessment must be made as to whether hazards relating to food safety, wholesomeness, or economic fraud can be associated with that particular step. Some categories of hazards are:

When identifying hazards at a control point it may be helpful to ask yourself some basic questions. For example:

Receiving

Question: What is the fishery product coming into my facility?

Answer: Fresh domestic fillets and frozen imported fish blocks.

Question: What hazards can be encountered?

Answer: Mislabeling; decomposition; filth; package integrity; bones; foreign/extraneous material; pathogens; thermal abuse; and physical damage.

Hazard analysis is a basic procedural step required in the development of the HACCP plan. Products have been placed into two groups for the Program: Substantial Risk and Low Risk. Products that pose a Substantial Risk are those products that are ready-to-eat; heat, brown, and serve; and some microwaveable products. Products which may contain a microbial pathogen, biotoxin, or physical or chemical contaminant which may pose an unacceptable health risk at the time of consumption are also considered to be Substantial Risk. All other potential risks will be considered Low Risk.

The hazard analysis step can be performed by one individual but works better when a team of specialized persons work together. Whichever your facility chooses, the methods remain the same. The hazard analysis is performed on the product as it relates to its final form. Each step of the process must be analyzed to identify any hazards that may affect the final product. Then the hazard is placed at the points on the flow chart where it can be controlled. There may be more than one point of control for a particular hazard. That is not of concern as yet. Remember that the hazards may be of a safety, wholesomeness, or economic fraud nature.

B. Determine Preventive Measures

The next step is to determine the preventive measures. Preventive measures are defined as any action that will inhibit the introduction of hazards into the product. Preventive measures can include:

For each hazard listed in your critical control points, list the preventive measures you can employ to reduce the possibility of that particular hazard of occurring.

C. Identify Critical Control Points

A "Control Point" (CP) is defined as any step in a process whereby biological, chemical, or physical factors may be controlled.

A "Critical Control Point" (CCP) is defined as any step in a process which, if not properly controlled, may result in an unacceptable safety, wholesomeness, or economic fraud risk. In order for a control point to be critical, one must be able to monitor and document the control of hazard(s) at that control point.

Types of critical control points may include, but are not limited to:

This is an opportunity to evaluate compliance with regulatory requirements, and if necessary, to correct any defects, deviations, or deficiencies that may be found.

Identify on the flow chart the steps that have been deemed critical control points.

D. Establish Critical Limits

A critical limit is defined as an established point which must not be exceeded if a hazard is to be controlled at a CCP. There may be more than one critical limit for a CCP. If any one of those limits is out of tolerance, the process will be out of control and a potential hazard or unacceptable risk can exist.

The critical limit is used by the firm to signal the fact that a potential hazard/problem exists at a particular critical control point. At this point, the firm will determine the possible solutions and decide which solution(s) will correct the hazard/problem.

The criteria most frequently utilized for limits are temperature, time, humidity, moisture level (Aw), pH, titratable acidity, preservatives, salt concentration, available chlorine, net weight, amount of breading, and fill of container. Critical limits can be quantitative (i.e., a number value) or qualitative (e.g., evidence of decomposition as determined by an organoleptic evaluation). They can be a maximum, minimum, or range value. Many different types of limit information may be needed for control of a critical control point.

It is important to establish reasonable critical limits that will ensure control of the potential hazard. The firm should set limits that are more stringent than regulatory limits or product purchasing specifications to ensure that product will be found acceptable.

E. Establish Monitoring Procedures

Monitoring is the scheduled testing and/or observations recorded by the firm to report the findings at each CCP. Monitoring results must be documented. Failure to exercise control of a critical control point is a critical deficiency in the Program.

A critical deficiency is defined as a hazardous deviation from plan requirements such that maintenance of the safety, wholesomeness, and economic integrity is absent, ultimately resulting in unsafe, unwholesome, or misbranded product. Because of the potentially serious consequences of a critical deficiency, monitoring procedures must be effective.

Ideally monitoring should be at the 100% level. Continuous monitoring is possible with some types of physical and chemical methods. However, when this is not possible, it is necessary to establish monitoring intervals that will reliably indicate that the hazard is under control.

Most monitoring procedures for critical control points will need to be done rapidly because they relate to on-line processes of the product. There will usually not be time for lengthy analytical testing. Physical and chemical measurements are usually preferred because they may be done rapidly. Microbiological testing, for example, is seldom effective for monitoring critical control points due to their time consuming nature. This is not to say these tests and methods cannot be effectively used for verification of the effectiveness of process controls.

For each critical control point list the procedures you will use to monitor your control of that specific critical control point. When listing these procedures be specific. List:

1. Who will perform the procedures
2. The frequency at which the procedure will be performed
3. Any associated criteria for the procedure. For example; sampling plans used, definitions of samples and/or lots, etc.

F. Establish Corrective Actions

Corrective Actions are defined as procedures to be followed when a serious or critical deficiency is assessed or when a critical limit is reached or exceeded. When critical limits are exceeded at a critical control point corrective actions must be taken to eliminate the hazard created by the deviation. These actions must also assure proper disposition of the product involved. Specific procedures for each critical limit of a critical control point must be developed. This is due to variations in product and the diversity of associated deviations.

Corrective Actions will involve:

1. A statement of the problem (usually in an “If… then” format)
2. Procedures for handling of the product
3. Identify the person responsible for the corrective action
4. Testing to establish the acceptability (if applicable)
5. Final disposition of the product
6. Documentation and signatures

G. Establish Records

For each critical control point you must provide a record that demonstrates monitoring procedures and corrective actions are being followed. Existing company forms or records may be adequate. The types of records that would demonstrate adequate documentation that critical control points are being controlled are: