U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
February 2001

DOMESTIC SEAFOOD HACCP REPORT
REVISED INSTRUCTIONS for FDA Form 3501
(Revised 2/01)

Below are instructions for filling out Form 3501, which FDA, state and contractor inspectors will use to record the results of Domestic Seafood HACCP Inspections. Inspectors should only utilize original Forms 3501, as they have imbedded codes, are serially numbered and cannot be reproduced.

1.   INTRODUCTION - REMINDERS AND WHAT'S NEW

Do not use a page or pages with different keynumbers (located in the bottom right corner of the form).

It is now optional to leave the yellow copy with plant management.

Reminder: Do not send or fax cover sheets with the 3501 form. Also, do not send documents other than the 3501 form.

The system will not accept form transmissions (facsimiles) which have extraneous marks anywhere on the form (e.g., writing or stamping over answer blocks or fields).

Report any data entry or facsimile problems to the Office of Seafood. Banyan has been replaced by e-mail.

The product code section has been modified to only include products that need to be added to the current Data Codes Manual. For detailed assistance with choosing a product code, refer to the product code builder found also on the web at http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.htm. The product code builder will replace the data codes manual section on product codes.

Product codes describe the finished product step, not the first step or an intermediate step. For example, hot smoked aquaculture salmon would be keyed 'I' in the third position to reflect hot smoked, not the intermediate step aquaculture (16I_ _ 32). Another example is hot smoked, cooked salmon keyed as 16I_ N 32 not 16I_ P 32.

a) Stuffed products and pies should be coded as product class 16C, G, L, or P_ _ _

b) Under product class 'W' - Mixed Fishery/Seafood Products, gumbo is coded as follows: 16W_ 21 (Seafood chowder/soups/stew/bisque/gumbo or 16W_ _23 - Congee, Seafood chowder/soups/stew/bisque/gumbo

c) Under product class 'Y' - Fishery Products, n.e.c., spread should be coded as 16Y_ _10 ("Dips" containing seafood)

d) NOTE: See Industry Code 18 for Fish Flavored Vegetable Proteins, Code 71 for Fish Meal, Code 54 for Fish Oil and Shark Cartilage and Code 52 for samples covering Shellfish Harvesting Areas, including samples for Fishery Products collected for residue analysis.

Even though page 3 may be blank, it still must be faxed with pages 1 and 2. If not, the system will mark the transmission incomplete.

2.   OVERVIEW

A.   GENERAL:

• Use one form set per each product inspected.

• Each page of the 3 page form set has 3 copies: Original (white), Agency Copy (pink) and Firm Copy (yellow).
  • The Original (white copy) should be retained by the FDA District Office or the State agency for its establishment files AFTER FAXING.

  • The Agency Copy (pink copy) of the form is to be used as needed, e.g. in federal/state partnerships.

  • The Firm Copy (yellow copy) of the form should be provided to and discussed with responsible firm management at the conclusion of the inspection.

• Each inspection form set is serially numbered. The number appears on each page, so the pages cannot be reproduced, or substituted with a different page and serial number.

B.   FILLING OUT THE FORM:

• Carefully insert flap of matchbook folder cover under the yellow copy of the page (i.e., there are three (3) individual copies of each page) you are marking, but not between carbons and colored pages.

• Use a black or blue ink ballpoint pen and press firmly to ensure that all information recorded appears on the carbon copies.

• Print legibly and in CAPS, allow one character per box, and keep all marks within a designated character response box.

• Respond to choice questions by darkening in the appropriate circle.

• If errors are made - To correct a character box, draw a circle around the box to indicate a mistake and then print the correct response above the error. To correct a choice selection, place an "X" through the circle and then darken in the correct circle.

WARNING: DO NOT place any marks in the checkered rectangle, labeled 28062, found in the lower right corner of each page; otherwise, your results may not be recorded.

C.   UPON COMPLETING THE INSPECTION:

• Optional: Review and discuss your findings with plant management and leave the "yellow" pages of the form (Firm Copy) with them.

• At your office, complete the "FOR OFFICIAL USE ONLY" section and obtain required reviews of the form before FAXING findings to Washington. FDA personnel must now complete this section so that an inspection classification status will be recorded in the database with each product inspection.

• Using an authorized FAX machine, transmit all 3 Original pages of the form (white copy) to the National Seafood HACCP Database, at FDA/CFSAN/Office of Seafood in Washington, DC using its dedicated database phone number. DO NOT SEND FAX COVERSHEETS. IF NECESSARY, TURN OFF THE AUTO COVERSHEET FUNCTION.

  NOTE: The transmission and receipt process will take less than 10 seconds per page if the FAX memory function is used to scan pages for transmission.

  Listen for receiving tone when transmitting. Upon completion, verify that all pages sent were received. Send all pages of the form, even if they were not all filled out during the inspection. Pages do not have to be in sequential order during FAXING.

  The HACCP database will not accept data transmissions which:
  - have extraneous marks anywhere on the form and especially in the checkerboard code box (lower right corner)
  -are not sent from an authorized FAX machine;
  - have missing pages; or
  - are illegible or have incomplete data entries.

  Report any data entry problems to the Office of Seafood at (202) 418-3133. Ask for Bruce Wilson, Donna Brown, or Roshelle King; or send them an email message.

4. COMPLETING SECTION 1 - GENERAL INFORMATION
BLOCK 1:	CFN/FEI: Enter the FDA Central File Number (CFN) or, when appropriate, the FDA Firm Establishment Identifier (FEI) number of the firm inspected. NOTE: If this is a new firm that is not currently listed in the FDA Official Establishment Inventory, do not write "NOCF". You must obtain a CFN or FEI number from the FDA District Office before faxing this form to the database. Leave blank only if firm is intrastate. You will identify firm as intrastate by answering question # ll as "yes."
BLOCK 2:	State Permit Number: This is optional information, except where a partnership agreement requires that it be collected. State inspectors may record the state permit number that is assigned to the firm inspected. If it is available, FDA investigators may also enter this information.
BLOCK 3:	Date of Inspection: Enter the date of the last day of the inspection (Month, Day, Year). EXAMPLE: 08/01/99.
BLOCK 4:	Inspected By: Enter the name of the inspector/investigator conducting the inspection (First, Middle Initial, Last).
BLOCK 5:	Firm Name: Enter the name of the firm or vessel inspected. Use common abbreviations where needed to fit within the space provided. Vessels are identified by answering "yes" in #7a. Address Information: Enter the street number, street name, city, state and zip code for the firm inspected. Use common abbreviations where needed to fit within the space provided. Use the postal abbreviation for the state name.

# 6: Inspection Basis: Identify whether the inspection was conducted by: FDA; under State or local contract; under State or local partnership agreement.

# 7: Establishment Type:

NEW: In choosing a product to inspect (Blocks 8 and 9), first, reinspect products that are currently listed as VAI or OAI, so that the firm's corrections and compliance status are updated. Now, you are free to select new products to evaluate.

BLOCK 8:	FDA Finished Product Code Information: Enter the appropriate code for the finished product covered by this form. Refer to your current Data Codes Manual (TN 98.1, 4/15/98) and product code builder (http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.htm) along with the following modifications Keep in mind that product codes describe the finished product, not an intermediate step. For example, hot smoked aquaculture salmon would be keyed "I" in the third position to reflect hot smoked, not the intermediate step aquaculture (16I_ _ 32). 8a. Industry: Auto-filled with "16". 8b. Class: Select the appropriate "Class" code. Enter as the 3rd digit of the code. Code pies and stuffed products as 16C, G, L, or P_ _ _ 8c. Container or Subclass: Select the letter code for the package type of the product covered by this form. Enter as the fourth digit of the code. 8d. Process Code or PIC: Select the letter code for the final process used for the product covered by this form. Enter as 5th digit of the code. 8e. Product ID: Your options for entering the 6th, and 7th digits of the code are based on how you responded to 8b, (3rd digit). Code Hoki as16A, B, C, I, or S_ _49 (Whiting) Code gumbo as 16W_ _21 (Seafood chowder/soup/stew/bisque, n.e.c.) or 16W_ _23 (Congee, Seafood chowder/soup/stew/bisque Do not include ("Dips" containing Seafoods Prod., 10) as 16Y_ _01 (caviar) Code spreads as 16Y_ _10 ("Dips" containing Seafoods) At a later date sea urchin roe will be coded as 16Y_ _15. Until then code as 16M_ _11 (sea urchin).
BLOCK 9:	Product Name: Enter a narrative description of the product covered by this form. The description must include the species and product form, for example: catfish, raw fillets; shrimp, raw peeled/deveined; shrimp, cooked peeled/deveined; tuna, canned; mako shark, steaks; etc.) A thorough hazard analysis dictates that you be specific.
#10: Was the firm actively processing the finished product you listed in Block 9? Your answer will allow reviewers to determine if the inspection fully evaluated HACCP and sanitation controls. #11: Does the firm deal only in intrastate commerce? #12: Does the firm meet HACCP training requirements? Signature block / date
4. COMPLETING THE "FOR OFFICIAL USE ONLY" SECTION All inspectors/investigators must complete this section.
BLOCK A:	FDA District/Agency Code: For inspections conducted by the FDA, enter the 1-digit Home District Code for the reporting District, in the far left block. For inspections conducted by a State or local agency, enter the three digit Agency Code. The first two positions are the alpha 2-digit state (postal) abbreviation, with corresponding alpha/numeric identifier in the 3rd position.
BLOCK B:	Employee Number: Enter the 3-digit FDA or State employee number.
BLOCK C:	Hours Expended: Enter the number of hours expended conducting the HACCP portion of the inspection for the product covered by this form. This block need not be completed for FDA inspections or inspections performed under contract.
BLOCK D:	Inspection Classification. All inspectors must complete. Check the appropriate classification of the inspection for the product covered by this form.
	DO NOT FAX this form into the database until the final inspection classification has been assigned by the District or State. Official Action Indicated - regulatory or administrative sanctions will be recommended. Voluntary Action Indicated - objectionable conditions were found but regulatory or administrative sanctions will not be initiated. Any corrective action the firm may take is voluntary. In some cases, the State may provide for accelerated reinspection of the firm. No Action Indicated - Firm has no objectionable conditions, or objectionable conditions found during the inspection were so minor that routine reinspection is the only action indicated.
BLOCK E:	Employee Phone Number: Enter the office phone number where the inspector/investigator can be reached for clarification of the information submitted. Include extension when needed.

5. COMPLETING SECTION II - HAZARD CONTROL

#13. Self-explanatory. If no, skip #14-26, complete SECTION III - SANITATION CONTROL

#14: Self-explanatory. If no, skip #15-26, complete SECTION III - SANITATION CONTROL

HACCP Plan Documentation / Implementation:

Questions #15 - 23 ask you to report only negative findings on HACCP Plan Documentation and HACCP Plan Implementation. So as to be fair and objective, please use your professional judgement in assessing the overall completeness and adequacy of meeting each compliance requirement.

Answer all questions #16-24. Each question stands alone.

# 24 - Process monitoring instruments needed to apply critical limits must be properly calibrated. Were they?

#25 & # 26 - Self explanatory. However, these are not HACCP requirements.

6. COMPLETING SECTION III - SANITATION CONTROL

#27 - #32 Report only negative findings. In answering, first determine which of the 8 sanitation items apply, then note every deficiency that applies by darkening in the appropriate circles. So as to be fair and objective, please use your professional judgement in assessing the overall completeness and adequacy of meeting each compliance requirement.

#33 - Self explanatory. However, while not a Federal HACCP requirement, this is mandatory in some States.

7. COMPLETING OPTIONAL COMMENTS / REMARKS SECTION

This page is primarily for the use and convenience of the investigator / inspectors and field reviewers. While State inspectors may use this page to keep their own notes, this page is not a substitute for FDA personnel entering findings on the FDA Form 483.

The material entered will only be examined at headquarters, during the data verification process , to resolve possible inconsistencies in inspection findings. Findings on this page will not be entered into the database.

These instructions were revised in February 2001.

Inspectors should only utilize original Forms 3501, as they have imbedded codes, are serially numbered and cannot be reproduced.

Sample FDA Form 3501

Hypertext updated by ear/dms/cjm 2001-JUL-11