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FDA Process Registration Forms 2541 and 2541a Module 2210

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1 FDA Process Registration Forms 2541 and 2541a Module 2210
Jim Goff Research Specialist Institute of Food Science & Engineering University of Arkansas

2 FDA Process Registration Forms
This series will cover how to fill out FDA Form 2541 (Food Canning Establishment Registration) and Form 2541a (FDA Process Filing for all Except Low Acid Aseptic Foods).

3 FDA Process Registration Form 2541; Food Canning Establishment Registration

4 2. Under “Products FDA Regulates”, click on Food.
Form 2541 is required to register a processing plant location. Any plant processing canned foods under 21 CFR 108, 113 and must register their plant with FDA. A. Obtaining forms. 1. Launch your internet browser and go to “www.fda.gov”. 2. Under “Products FDA Regulates”, click on Food. 3. Under “Program Areas”, click on “Acidified and Low Acid Canned Foods”. 4. Under “Registration, Process Filing Forms, Instructions and Guidelines” click on PDF and download “Food Canning Establishment Registration FDA 2541" as an Adobe® Acrobat® document. You must have Adobe® Acrobat® Reader 5.0 to read the document. is also available from the FDA as a complete pack with built-in carbons.

5 B. Filling Out Forms 1. Print all four pages of Form 2541. 2. Detailed directions for registering your plant are available from the FDA at their website: 3. For FDA Use Only Section: Make no mark in this section. 4. Type of Submission: Check "Initial Registration" if this processing plant has never been registered before. Leave the space for "Current FCE" number blank.

6 Check “Relocation (new registration Required) If a previously registered establishment has moved to a new location. Enter your current Food Canning Establishment (FCE) number in the space provided. Complete all other spaces on the form as in an initial registration. FDA will assign a new FCE number and return a copy of the form as for a new registrant. The old FCE is invalid and may not be used. Check "Change of Registration Information" if you are submitting changes such as the following for a previously registered firm: * Change in firm name * Change in mailing address * Change in ownership * Change in postal address because of renaming of street, renumbering of building, etc. (no actual change in location). Enter the type of change and the current FCE number in the space provided.

7 5. Food Processing Plant Location: Give name of the processor and the
5. Food Processing Plant Location: Give name of the processor and the address of the physical location of the processing operation. Do not give a Post Office Box number. 6. Preferred Mailing Address: If mailing address is the same as the plant location check the “Same as Plant Locatiom” Box. Otherwise give office address information. 7. Low Acid and/or Acidified Foods Processed at This Location. List all products produced and whether they are low acid or acidified. 8. Please Send the Following: FDA will provide forms for filing. Fill in the number of each form needed. 9. Leave no blank spaces on the form. It will be sent back to you for clarification.

8 File the second (pink) copy. Send the remaining copies to:
LACF Registration Coordinator (HFS-618) Center for Food Safety and Applied Nutrition (FDA) 5100 Paint Branch Parkway College Park, MD 11. Your Food Canning Establishment (FCE) number will be sent to you.

9 Form 2541a; FDA Process Filing for all Except Low Acid Aseptic

10 A. Obtaining forms. 1. Launch your internet browser and go to “www.fda.gov”. 2. Under “Products FDA Regulates”, click on Food. 3. Under “Program Areas”, click on “Acidified and Low Acid Canned Foods”. 4. Under “Registration, Process Filing Forms, Instructions and Guidelines” click on PDF and download “Process Food Canning Establishment Filing for All Methods Except Low Acid Aseptic FDA 2541a" as an Adobe® Acrobat® document. You must have Adobe® Acrobat® Reader 5.0 to read the document. 5. Print both pages of Form 2541a

11 6. 2541a is also available from the FDA as a complete pack with
a is also available from the FDA as a complete pack with built-in carbons. B. Filling out forms 1 Detailed directions for filing a process are available from the FDA at their website. 2. The services of a Processing Authority may be required to determine safe processes for low acid canned foods. 3. The University of Arkansas Institute of Food Science and Engineering can assist with process determination for high acid or acidified foods.

12 4. Section A: Product a. Name, Form or Style, and Packing Medium. Describe the product, i.e. Green beans (cut) in brine b. pH before acidification. Enter the pH. ( e.g ). c. Governing Regulation. Check either low-acid or acidified depending upon the process to be used. d. Type of Submission. Check either “new” or “replaces” and give date of process replaced or “cancels” and give date of process canceled. e. Process Use. Check “scheduled” for process to be used in plant or “alternate for” and give date of the process for which this is an alternate or “emergency for” and give date of process for which this is an emergency filing.

13 d. FCE. Enter Food Canning Establishment number.
e. SID. Enter Submission Identifier. Enter date as YYYY-MM-DD. SSS is the number of the submission if more than one were made on a given date, ( e.g ). Section B. Processing Method a. Name of Sterilizer (Mfg and Type) ( e.g. FMC Sterimatic ) b. Heating Medium (e.g., Steam, water, immersion or spray, steam- air) Describe the method of heating in the retort. c. Select type of retort. Check the box which identifies the type of retort. If 21 CFR and 114 was marked as the governing regulation, process is for an acidified food, check “Acidified” and list the pH, Method of Acidification, Acidifying Agent, Pasteurization Method, Preservatives Used and Concentrations.

14 d. Container Type. Select the box which describes the container
d. Container Type. Select the box which describes the container being used. e. Process Establishment Source. This may be a standard reference such as NFPA Handbook 26L or from a Processing Authority. f. Date Last Established. Give most recent date of process from Process Establishment Source. g. Process Recommendations Attached? This is not required but clarification but may be requested by FDA. Recommendations and data of a Processing Authority should be attached if it is deemed necessary to support the process data.

15 6. Section C: Critical Factors
a. Critical Factors are items whose variance will have a potential to cause underprocessing and Public Health dangers. b. All products must be evaluated by a Processing Authority to determine Critical Factors. c. Every product will not have all the Critical Factors listed in Section C. Those that are found to apply to a specific product must be identified and steps taken to assure compliance. Page 2. Scheduled Process a. Enter FCE (Food Canning Establishment) and SID (Submission Identifier). b. Container Dimensions. 1. Cont. No. The product described on the first page may be packed in any number of sizes of container. Each different container must be given a container number.

16 2. Diameter or Length. Give the diameter of the can in inches
2. Diameter or Length. Give the diameter of the can in inches and sixteenths ( e.g. 603). For other packages give longest dimension as length in inches and sixteenths. 3. Height or Width. Give the height of the can in inches and sixteenths ( e.g. 700 ). For other packages give shorter dimension as width in inches and sixteenths. 4. Height of Maximum Pouch or Semi-rigid Container Thickness. Lay container on a flat surface and measure maximum height in inches and sixteenths. c. Capacity Units. Check box to indicate units ( e.g. oz.). Place capacity on line for each size.

17 d. Scheduled Process (Check Only One in Each Column).
1. Step No. Enter 1 unless multi-shell retort or hydostatic retort is used. Then each shell is a separate step. Some hydrostatic retorts will have multiple steps. 2. Temp (°F). Mark Check Box for appropriate data. Check minimum initial temperature (Min IT) for Low Acid Canned Food (LACF), or minimum initial temperature (Min IT) or Fill or Center temperatures for Acidified or aw Controlled. Check N/A if not applicable. Enter temperature in whole °F ( e.g. 110 ) in table on correct line. 3. Process Time (Minutes). For Low Acid Canned Food (LACF) mark check box for Process Time. For Acidified or aw Controlled check Process Time, or Hold Time. Enter time in hundredths of minutes ( e.g ).

18 4. Sterilization Temp (°F). For Low Acid Canned Food (LACF)
4. Sterilization Temp (°F). For Low Acid Canned Food (LACF) mark check box for Process Temp. For Acidified or aw Controlled check Process Temp. or N/A. Enter Temperature to nearest whole °F ( e.g. 248 ) in table on correct line. 5. Least Sterilizing Value of the Scheduled Process. Mark Check box for F0 (Equivalent Minutes at 250°F) or Other F Value. If Other F Value is marked, list Death Rate (z) and Ref. Temp. (T) used to calculate value. Check IS Value if Integrated Sterilization Value computer programs were used. Check Other if an equivalent scientific method is used. Identify the method on the line by the box. Enter F0 in tenths of units ( e.g ). e. Other Critical Factors to Assure Commercial Sterility Per Source Authority

19 1. Thruput. For rotary or continuous retorts, thruput is the number of
1. Thruput. For rotary or continuous retorts, thruput is the number of containers processed per minute. For still retorts mark the N/A check box. 2. Headspace. Net Head space is the distance from the can end to the solid product level. Gross Head space is the distance from the can end to the brine or syrup. For still retorts head space is not important, but for agitating retorts head space is critical because it is the air bubble in the head space that agitates the contents of the can. Mark the applicable check box and enter the head space in ten-thousandths of an inch ( e.g ). 3. Speed. For still retorts check N/A. For rotary and orbital record Reel Speed in hundredths of an RPM ( e.g ); Reel Diameter to the nearest inch ( e.g. 048 ) and Steps per Turn of Reel by actual count of container position in a reel ( e.g. 064 ). For hydrostatic retorts record Chain/Conveyer Speed in Feet, Carriers or Flights per Minute in hundredths ( e.g ) and mark the correct check box

20 4. Maximum Weight. For some processes the amount of product in the
4. Maximum Weight. For some processes the amount of product in the container is a critical factor. Some processes may state the uncooked fill weight and others may state the post cook drained weight. Mark the correct check box. Record the Maximum Weight in hundredths of an ounce ( e.g ). If not a factor, check N/A. 5. Minimum Net Weight. For some processes a minimum amount of fill is required to achieve proper heat transfer. Record the Minimum Weight in hundredths of an ounce ( e.g ). If not a factor, check N/A. 6. Minimum Free Liquid at Closing. For vacuum pack processes only, enter the minimum free liquid in the container (in ounces) at closing. Express to the nearest tenth (e.g., 01.3). If not applicable, check N/A.

21 7. Minimum Container Closing Machine Gauge Vacuum. For vacuum
7. Minimum Container Closing Machine Gauge Vacuum. For vacuum pack processes only, enter minimum container closing machine gauge vacuum if specified by the process source to be critical. Express in whole inches of mercury (Hg). In the column heading, enter the temperature at which measured If not applicable, check N/A. 8. Other ( Specify ). Factors not previously listed which affect the process can be specified in this section. f. Comments. Use this section to make notes which will clarify any listing on the form. g. Plant Name/Address. Enter the physical address of the plant which corresponds to the FCE number on this form. h. Preferred Mailing Address. Enter the mailing address if used.

22 Authorized Individual. Print (or type) the Full Name of the
Authorized Individual. Print (or type) the Full Name of the authorized representative who is signing this form on behalf of the company and the telephone Number at which he can be reached. Sign and date the form. If someone other than an employee or officer of your company signs the form, FDA must have on file, a letter from your company authorizing this person or organization to act on your behalf. j. The pink copy of all filings must be retained in the plant. Mail the original form to: LACF Registration Coordinator (HFS-618) Center for Food Safety and Applied Nutrition (FDA) 5100 Paint Branch Parkway College Park, MD

23 Produced and narrated by Jim Goff
For further information contact: Jim Goff University of Arkansas Institute of Food Science and Engineering 2650 N. Young Avenue Fayetteville, AR (479) FAX (479)

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