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National Shellfish Sanitation Program
Guide for the Control of Molluscan Shellfish
2003

Guidance Documents

Chapter III. Harvesting, Handling, Processing, Distribution

.02 Shellfish Plant Inspection Standardization Procedures

Table of Contents


Introduction to Plant Standardization

PURPOSE:

In 1988, the Interstate Shellfish Sanitation Conference (ISSC) adopted, as a primary goal, an initiative to standardize FDA Regional Shellfish Specialists and State Standardization Officers. The Conference affirmed that standardization of shellfish regulators will result in uniform plant inspections and strengthen consumer confidence in shellfish products. In 1991, the Conference adopted issue 91-222 requiring the certification of the shellfish plant inspections before listing in the Interstate Certified Shellfish Shipper's List (ICSSL), effective January 1, 1994. As a result of that issue, FDA developed procedures to standardize Regional Shellfish Specialists and State Standardization Officers. The requirements and criteria described in this Standardization procedures document apply only to standardization of the Regional Shellfish Specialists and State Standardization Officers.

OBJECTIVE:

The standardization process provides regulatory personnel the opportunity to standardized their knowledge and skills related to the National Shellfish Sanitation Program (NSSP) Model Ordinance (MO) with the knowledge and skills of FDA's National Plant Standard(s) and/or Regional Shellfish Specialists. The process and criteria for demonstrating uniformity in the required performance areas are described in Chapter 4.

Through the application of this procedure, the Candidate should demonstrate uniformity with "the Standard" or “State Standardization Officer” through his/her knowledge and expertise in the application and interpretation of the MO requirements for HACCP principles, sanitation, and the use of the NSSP STANDARDIZATION SHELLFISH PROCESSING PLANT INSPECTION FORM. The application of this procedure is not intended to provide basic shellfish plant sanitation training to individual Candidates.

DEFINITIONS:

The following definitions apply in the interpretation and application of this procedure.

    (1) CANDIDATE means an individual applying for initial Standardization who has completed
          the prerequisite requirements or/and an applicant who is applying for re-standardization.

    (2) MODEL ORDINANCE (MO), also known as "Guide for the control of molluscan shellfish,"
          provides readily adoptable standards and administrative practices necessary for the
          sanitary control of molluscan shellfish.

    (3) NATIONAL STANDARDIZATION OFFICER, also known as "FDA's National Plant Standard,"
          means an FDA individual(s) at the national level responsible for interpreting NSSP MO requirements
          for shellfish plant operations. The Standard represents the FDA position on all Standardization issues.
          The Standard is also responsible for standardizing FDA Regional Shellfish Specialists.

    (4) NOMINEE means the applicant designated for standardization based on the procedures
          contained in this document.

    (5) STANDARDIZATION means the process whereby a Candidate demonstrates the
          knowledge and skills necessary to be considered uniform with the Standard as defined
          in the National Shellfish Sanitation Program's (NSSP), Plant Standardization Procedures.

    (6) STANDARDIZED INSPECTOR means a state/federal shellfish plant inspector who has
          been authorized to certify shellfish shippers as demonstrated by successfully passing a
          standardized test.

    (7) STATE STANDARDIZATION OFFICER means a state shellfish program employee
          who has met the qualification requirements in the National Shellfish Sanitation Program Plant
          Standardization Procedures and successfully completed field standardization inspections with
          a Standardized FDA Regional Shellfish Specialist.



Standardization Participants

FDA

The FDA National Plant Standard(s) will be responsible for standardizing all Regional Shellfish Specialists. Standardized FDA Regional Shellfish Specialists will standardize the State’s "Standardization Officer" Candidate(s). The FDA National Standard will conduct standardization inspections to evaluate and assure the proficiency of the FDA Regional Shellfish Specialists. The Standardization inspection process will consist of three (3) practice inspections and five (5) standardization inspections.

STATE

Each participating state will sponsor an adequate number of individuals for positions as State Standardization Officers and inspectors to guarantee that each certified shellfish dealer is routinely inspected for compliance with the MO plant processing requirements. The State should select no more than two (2) individuals as Shellfish Standardization Officers. The FDA Regional Shellfish Specialists will conduct standardization inspections to evaluate and assure the proficiency of the State Standardization Officer(s). The Standardization inspection process will consist of three (3) practice inspections and five (5) standardization inspections.

State Standardized Inspectors are standardized by State Standardization Officers. Each State shall provide the necessary resources to support the training of state shellfish inspectors by the State Standardization Officer(s) to ensure that each shellfish firm receives uniform routine inspections. The State Standardization Officer also has the option of sanctioning the participation of local, city, and/or county shellfish plant inspectors. It is recommended that the State Standardization Officer standardize State Standardized Inspector Candidates utilizing the same standardization procedures identified for State Standardization Officers.


Qualifications For Standardization

This chapter defines those requirements that the Candidate must complete prior to standardization. In order for a Candidate to engage in the process of initial field standardization, they will qualify by completing the prerequisite and experience requirements specified in this chapter. Those requirements only apply to first time applicants applying for standardization.

QUALIFICATIONS FOR STATE PERSONNEL:

When nominating a Candidate, the supervisor making the nomination should provide the required Candidate background information on the STANDARDIZATION NOMINATION FORM (Attachment 1). This information will be maintained in a file at the appropriate FDA Office.


QUALIFICATIONS FOR FDA PERSONNEL:

When nominating a Candidate, the supervisor making the nomination should provide the required Candidate background information on the STANDARDIZATION NOMINATION FORM (Attachment 1). This information will be maintained in a file at the Division of Cooperative Program Office.

All Standardization Candidates shall meet the following performance criteria:

      (a.) HACCP: The Candidate shall demonstrate the ability to verify that HACCP Plan exists
            and is being adequately implemented by the dealer.

      (b.) SANITATION ITEMS: The Candidate shall demonstrate the ability to recognize, through
            records review, the "8" National Shellfish Sanitation Program (NSSP), Model Ordinance (MO),
            “02 Sanitation Items" are being adequately monitored and that those records are accurate
            and complete.

      (c.) ADDITIONAL MO REQUIREMENTS: The Candidate shall demonstrate knowledge of the
            NSSP Model Ordinance, “03 Other Model Ordinance Requirements", and “Good Manufacturing
            Practice” (GMP) by correctly identifying deficiencies relating to those items during the field
            evaluation process.

      (d.) INSPECTION EQUIPMENT: The Candidate shall be equipped and familiar with the equipment
             necessary to conduct a Shellfish plant inspection. The Candidate shall be evaluated on the
             proper use of inspection equipment during the standardization process.

The following is a MINIMUM list of required forms and equipment for use during shellfish plant inspections:

     (e.) COMMUNICATION: The Candidate shall demonstrate the ability to effectively communicate
            with plant management about deficiencies noted during the evaluation. Many different types of
            communication skills and approaches are necessary and valuable during the inspection process.
            The Candidate shall be required to take the lead in communicating with industry personnel
            during all inspections and the Standard shall evaluate the Candidate’s communication skills.

INTRODUCTION:
The Candidate shall be required to make all introductions. A complete introduction consists of: 

      (a.) Introducing all persons participating in the inspection;

      (b.) Describing the purpose and flow of the inspection;

      (c.) Identifying and explaining to the PERSON IN CHARGE that it will be necessary
            to ask questions about the operation during the inspection; and

      (d.) Explaining that this is not intended as a regulatory inspection and that there will be no written report
             left at the end of the inspection; however, significant findings will be brought to the attention of the
             PERSON IN CHARGE.

In addition to verbal and written communication, the Candidate shall also use the inspection process to communicate and demonstrate FOOD SAFETY concepts by example. Activities such as proper hand washing, sanitizing thermometer before probing shellfish, and wearing the proper inspection apparel should be used to reinforce spoken and written communications.


INTERVIEW WITH THE PERSON IN CHARGE:
The Candidate shall conduct a discussion with the PERSON IN CHARGE to determine:

(a.) If a HACCP PLAN exists, and if so, whether the PERSON IN CHARGE
             understands the principles of the HACCP PLAN and is ensuring that the employees
             are effectively using the plan.

EXIT CONFERENCE:
The Candidate, at the exit of conference shall clearly convey and discuss in detail with the PERSON IN CHARGE the inspection findings including:


      (a.) The compliance status of the firm describing each significant violative condition and, where
             appropriate, acceptable compliance alternatives,

      (b.) The response and plans of the PERSON IN CHARGE for correcting violations, and

      (c.) Corrective actions observed during the inspection. Such proactive food safety measures
             shall be commended.

             Explain the public health significance of the deficiencies and demonstrate the ability
             to discuss and resolve in a courteous and professional manner, issues that the PERSON IN
             CHARGE might not agree with or clearly understand.

Table 1: Summary of evaluation methods for initial STANDARDIZATION.
PERFORMANCE AREA FIELD STANDARDIZATION
HACCP (Items 1 - 7) Evaluation of existing HACCP Plan
Sanitation (Items 8 - 16) Evaluation/inspection
Additional MO Requirements (Items 17 - 30) Evaluation/inspection
Inspection Equipment Observation
Communication Observation


Pre-standardization Field Procedure

Pre-standardization - This phase consists of three (3) joint "practice" field inspections by the Candidate and the Standard. During these “practice” inspections there will be open discussion between the Candidate and the Standard on all matters relating to the standardization process including: the NSSP Model Ordinance interpretations, inspection form debiting requirements (where is "it" marked on the form); questions and discussions relating to the firm's HACCP plan; related Sanitation and Monitoring records and Corrective Action. The current edition of the NSSP Standardized Shellfish Processing Plant Inspection Form (Attachment 4) will be used during all aspects of the standardization procedure.

During pre-standardization inspections, the Standard and Candidate shall conduct the inspection together and discuss each noted deficiency. They shall agree on the number of times and locations where a specific deficiency was observed in the plant.

Following pre-standardization, the Standard may decide that the Candidate is unprepared to proceed to the formal field standardization process. If the Standard determines the Candidate needs additional field training, after discussion with the Candidate, they may decide to complete additional "practice" inspections. If the Standard determines that more "practice" inspections will not help in the Candidate's understanding of the process and/ or procedure then the Candidate and Candidate's supervisor will be informed.

Field Standardization Procedure

The Field Standardization Process consists of the Standard and the Candidate jointly conducting five (5) shellfish plant evaluations. Always select five (5) Shucker/packer (SP) plants if they are available. If a state has less than five (5) Shucker/packer's (SP), then the remaining plants will be selected according to the following priority:
      
      1) Repackers (RP)
      2) Shellstock Shippers (SS)
      3) Reshippers (RS)

During all joint field inspections, the Candidate will be the lead person. He or she will be responsible for the following: Introduction (determining who is the "most responsible" person), requesting the firm's HACCP Plan and its related documents, and sanitation monitoring records. The minimum number of records required for review will be at least three months. The Candidate shall also conduct the "exit" interview and discuss all significant deficiencies with management.


Standardization Scoring

COMPARISON OF FINDINGS:
Following each inspection, the Standard shall compare his/her findings with the Candidate. At the conclusion of the field standardization, the Standard shall tabulate and compare the Candidate's inspection findings to determine if the Candidate has successfully completed the requirements for Standardization. The Standard shall discuss any differences, results and other observations with the Candidate.

The Standard will evaluate each inspection report to determine the number of disagreements (using Standardization Requirements below) between the Standard and the Candidate. Disagreements shall be recorded on the Comparative Results form provided as Attachment 2.

CANDIDATE SCORING: The Standard shall grade each inspection report by circling each incorrectly marked item. The Standard shall determine the number of disagreements on items and record that number in the form provided in ATTACHMENT 3. For inspectional equipment and communication scoring is not used but impacts the outcome of the Candidate's performance.

The Candidates shall meet the following level of agreement to achieve Standardization after completing five (5) formal field evaluations.

      (a.) HACCP: (item 1-7)
             The Candidates SHALL NOT DISAGREE with the Standard more than an average
             of three (3) times in five (5) evaluations.**

      (b.) Sanitation Items: (item 8- 16)
             The Candidates SHALL NOT DISAGREE with the Standard more than an average of
              three (3) times in five (5) evaluations. **

      (c.) Other Model Ordinance Requirements: (item 17 –30)
             The Candidates SHALL NOT DISAGREE with the Standard more than an average
             of four (4) times in five (5) evaluations. **

      (d.) Inspection Equipment: The Candidates SHALL have all essential equipment, listed in
             Chapter 4 "Performance Criteria for Field Standardization" available for use during
             each inspection. This section shall rate as SATISFACTORY or NEEDS IMPROVEMENT.

      (e.) Communications: The Candidates SHALL communicate per the requirements in Chapter 4
             "Performance Criteria for Field Standardization". This section shall rate as SATISFACTORY
             or NEEDS IMPROVEMENT.


**NOTE: With the exception of Candidates deficiencies that were not observed by the Standard


CRITERIA FOR SUCCESS STANDARDIZATION:

To achieve standardization, the Candidates shall meet requirements for the Performance criteria (a-c) described in Chapter 4. The Candidates may receive “Needs Improvement” classification in the section inspectional equipment and communications and still be standardized.

When either inspection equipment or communication performance area are classified as needing improvement, the Candidates and the Candidate's supervisor shall be notified that the “Needs Improvement” area(s) must be satisfactorily addressed before restandardization is granted. Prior to restandardization, the Candidate's supervisor must notify the Standard that the area(s) or concern has been addressed.


Standardization Results

REPORTING

The Standard and Candidate shall describe on the narrative section on the NSSP SHELLFISH PROCESSING PLANT FORM each specific deficiency and location within the firm where the deficiency was observed. The Candidate shall not fail to recognize any critical items. After each inspection has been completed, the Standard shall compare the number and description of the deficiencies found in the plant for each item on the narrative section of the NSSP Standardized Shellfish Processing Plant Inspection Form. The Standard shall determine if both observed the same specific deficiencies throughout the plant.

The Standard will use the Comparative Results Form (Attachment 2) to determine the level of agreement between the Standard and Candidate. At the conclusion of the formal Field Standardization exercise, the Standard will complete a Composite Results Report (Attachment 3).

After successfully completing the Field Standardization Exercise, the Candidate will be granted the TITLE of STANDARDIZATION OFFICER OR STANDARDIZED INSPECTOR. A certificate recognizing that accomplishment will be forwarded to the Candidate, along with formal notification to the Candidate's supervisor, within thirty (30) days.


Standardization (Maintenance)

STANDARDIZATION EXPIRATION:

The Candidate's STANDARDIZATION is valid for a period of 5 years. Expiration dates will appear on the certificate issued by the Standard.

STANDARDIZATION MAINTENANCE:

The maintenance process consists of joint inspections conducted during evaluation activities. Maintenance will also be provided in the form of updated FD 2041 Shellfish State Standardization Officer courses, ORA University web based course, updated field standardization guides, and other guidance/technical assistance activities on an as needed basis.


Termination, Suspension, or Revocation of Standardization
TERMINATION OF FIELD STANDARDIZATION:

      (a.) The Standard has the option to terminate the field exercise at any time during the procedure
             if the Candidate, in the opinion of the Standard, is not achieving the required level of agreement for standardization.

      (b.) The Standard shall notify the Candidate and the Candidate’s supervisor
             in writing of the reasons for failure.

      (c.) The Standard will document the reason(s) for termination of the field. This information
             shall be forwarded to the Candidate's supervisor and a copy shall be placed in the FDA file.
             All evidence and conclusions reached by the FDA shall be documented in writing by the Standard
             and shall be kept for 3 years in accordance with the Freedom of Information Act.

SUSPENSION/REVOCATION OF STANDARDIZATION CERTIFICATION

      (a.) Fails to utilize and/or properly complete the current NSSP Standardized Shellfish Processing Plant Inspection Form.


      (b.) Fails to properly code (critically code) deficiencies (critical, key, and other) on the
             NSSP STANDARDIZATION SHELLFISH PROCESSING PLANT INSPECTION FORM.

      (c.) Fails to fulfill the required maintenance activities described in CHAPTER 9.

      (d.) Before suspension or revocation, the Standard will consult with appropriate personnel in the
             FDA and/or the State’s agency to reach a decision on whether:

                          i. The standardization shall be suspended temporarily with notice regarding
                             conditions required for reinstatement; or

                          ii. The standardization shall be revoked.

      (e.) When a STANDARDIZATION certificate is revoked or suspended, the Standard
             shall
notify the supervisor in writing, of his/her decision.

      (f.) The Standard will document the reason(s) for suspension or revocation of the standardization
             certification. This information shall be forwarded to the Candidate's supervisor and a copy
             shall be placed in the FDA file. All evidence and conclusions reached by the FDA shall be
             documented in writing by the Standard and shall be kept for 3 years in
             accordance with the Freedom of Information Act.

RE-STANDARDIZATION AFTER SUSPENSION OR REVOCATION.

The Candidate may apply for re-standardization, within thirty (30) days, after suspension or revocation. He or she must contact and work with the appropriate FDA or *State Standardization Officer to correct all prior deficiencies before the re-standardization process begins.

NOTE: State Standardization Officers can only standardize their inspectors. Only FDA National Standards or standardized FDA Regional Specialists can standardize state standardization officers.


Appeals


FILING AN APPEAL.

Candidate after being notified of a failure to successfully achieve Standardization or re-standardization may appeal the decision. Should the Candidate elect to appeal, this action must be initiated within thirty days (30) of the date of the written notification of the failure, suspension or revocation. The appeal’s request shall be addressed to the FDA Standard Officer at FDA, Division of Cooperative Programs, 5100 Paint Branch Parkway, College Park, MD 20740.

APPEAL BOARD MEMBERS.

The FDA National Plant Standard and representatives from the ISSC and FDA Regional Shellfish Specialist will comprise the STANDARDIZATION Appeals Board. The ISSC will select states representatives to participate in the appeals process.

HEARINGS.

If the Appeal Board finds the appeal unjustified, the decision of the FDA Standard will stand.

If the Appeal Board determines that the State Standardization Officer's appeal is justified, the State Standardization Officer and the FDA Standard will be notified in writing that a hearing will be scheduled.

HEARING PROCEDURE.

At the hearing, the following procedure will be followed:

    (1) The State Standardization Officer will present his/her argument for reversing the FDA
          Standard’s
decision;

    (2) The Appeal Board will have the opportunity to question the action or conduct of the State
          Standardization Officer and the FDA Standard; and

    (3) The Appeal Board will render a decision.

 

ATTACHMENT I

STANDARDIZATION NOMINATION FORM

TO:
FROM:
SUBJECT: REQUEST FOR STANDARDIZATION
DATE:
 
Name:
Title:
Agency Name:
Address:

City/State/Zip:

Telephone:

Fax:

Education: (list degree or include a transcript)

Length of Service:

Describe shellfish experience:






CHECK (X) BELOW COURSES ATTENDED:
Basic Shellfish Plant Sanitation ( )
Basic Seafood HACCP Alliance Course ( )
Regulator’s HACCP Course ( )
List Other Courses



How many routine shellfish plant evaluations per year?

1 - 5 ( ) 6 - 10 ( ) >20 ( )



ATTACHMENT 2

COMPOSITE PERFORMANCE REPORT

FIRM NAME: Candidate(O) Standard(X) Disagreements
#1 HACCP Plan      
#2 Plan Elements (a) Hazards      
#2 Plan Elements (b) Records      
#2 Plan Elements (c) Critical Limits      
#2 Plan Elements (d) Signed and Dated      
#2 Plan Elements (e) Critical Control Points      
#2 Plan Elements (f) Monitoring      
#2 Plan Elements (g) Verification Procedures      
#2 Plan Elements (h) Corrective Action if identified      
#3 HACCP Training      
#4 Plan Implementation (a) Receiving      
#4 Plan Implementation (b) Shellstock Storage      
#4 Plan Implementation (c) Processing      
#4 Plan Implementation (d) Shucked Meat Storage      
#4 Plan Implementation (e) Other Critical Limits      
#5 Approved Source Control Failure      
#6 Time/Temperature Control Failure      
#7 Other Critical Control Failure      
TOTAL NUMBER OF DISAGREEMENTS      

SANITATION ITEMS

#8 Safety of water for processing and ice production      
#9 Condition and cleanliness of food contact surfaces      
#10 Prevention of cross-contamination      
#11 Maintenance of hand-washing, hand sanitizing, toilet facilities      
#12 Protection from adulterants      
#13 Proper labeling, storage, and use of toxic compounds      
#14 Control of employees with adverse health conditions      
#15 Exclusion of pests      
#16 Sanitation Monitoring and Records      
TOTAL NUMBER OF DISAGREEMENTS      

ADDITIONAL MODEL ORDINANCE REQUIREMENTS

#17 Plants and Grounds      
#18 Plumbing and related facilities      
#19 Utilities      
#20 Insects and vermin control      
#21 Disposal of other waste      
#22 Equipment construction (non-food contact surfaces)      
#23 Cleaning non-food contact surfaces      
#24 Shellfish storage and handling      
#25 Heat shock      
#26 Personnel      
#27 Supervision      
#28 Transportation (To include only the person shipping)      
#29 Labeling and Tagging (Other than receiving)      
#30 Shipping Documents and Records      
TOTAL NUMBER OF DISAGREEMENTS      

FIELD REQUIREMENT FOR THE SUCCESSFUL COMPLETION OF STANDARDIZATION

In order for the Candidate to successfully complete standardization he/she must meet the following field standardization criteria after five (5) evaluations:



ATTACHMENT 3

SHELLFISH PLANT STANDARDIZATION

"Candidate vs Standard: Composite performance chart"

NUMBER OF DISAGREEMENTS

FIRM NAME HACCP SANITATION ITEMS ADDITIONAL MO REQUIREMENTS
       
       
       
       
       
TOTAL      
*Average Score      
Acceptable Avg. Score 3 3 4
INSPECTIONAL EQUIPMENT SATISFACTORY NEEDS IMPROVEMENT
COMMUNICATION SATISFACTORY NEEDS IMPROVEMENT

*The Candidate's average composite score through five (5) formal standardization inspections meets (OR DOESN'T MEET) the acceptable average score required to achieve standardization.


STANDARDIZATION LOCATION:

DATE(S):

CANDIDATE:

STANDARD:

NSSP Standardized Shellfish Processing Plant Inspection Form

Agency Name: Date:
Type of Inspection O Certification         O Pre-operational          O Routine
O Follow-up            O Standardization
Dealer
Name:
  Certification Number:

Dealer Address:

 
  Hazard Analysis Critical Control Point (HACCP)  
1. HACCP Plan             OYes             ONo            Required for Certification
2. Plan Elements

Identified and Adequate

/x
NA
Code   /x
NA
Code Overall
Code
(a) Hazards   O (e) Critical Control Points   K
(b) Records   O (f) Monitoring   K
(c) Critical Limits   K (g)Verification Procedures   O
(d) Name, Address, Signed and Dated   O (h) Corrective Action if identified   K
3. HACCP Training           O Yes   O No Code O  
4. Plan Implementation Corrective Actions (C) Verification Procedures (K) Monitoring Procedures (K) Records Accurate/
Maintained (K)


Records Format
Signed/Dated
Firm's Name (O)
Overall
Code
/x Code /x Code /x Code /x Code
(a) Receiving
               
(b) Shellstock Storage
               
(c) Processing
               
(d) Shucked Meat Storage
               
(e) Other Critical Limits
               
5. Approved Source Control Failure   C  
6. Time/Temperature Control Failure   C
7. Other Critical Control Failure   C
  Sanitation Items Citation /x Code
8.

Safety of water for processing and ice production

.02A    
9. Condition and cleanliness of food contact surfaces .02B    
10. Prevention of cross-contamination .02C    
11. Maintenance of hand-washing, hand sanitizing, and toilet facilities .02D    
12. Protection from adulterants .02E    
13. Proper labeling, storage, and use of toxic compounds .02F    
14. Control of employees with adverse health conditions .02G    
15. Exclusion of pests .02H    
16. Sanitation Monitoring and Records     K
  Additional Model Ordinance Requirements Citation /x Code
17. Plants and Grounds .03A    
18. Plumbing and related facilities .03B    
19. Utilities .03C    
20. Insects and vermin control .03D    
21. Disposal of other waste .03E    
22. Equipment construction (non-food contact surfaces) .03F    
23. Cleaning non-food contact surfaces .03G    
24. Shellfish storage and handling .03H    
25. Heat shock .03I    
26. Personnel 03J    
27. Supervision .03K    
28. Transportation (To include only the person shipping) IX.05   K
29. Labeling and Tagging (Other than receiving) X.05, .06   S (K/O)
30. Shipping Documents and Records X.07   K
Dealer’s Signature

Inspector’s Signature

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