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FDA Process Registration Forms 2541 and 2541aModule 2210

Jim GoffJim Goff

Research SpecialistResearch Specialist

Institute of Food Science & Institute of Food Science & EngineeringEngineering

University of ArkansasUniversity of Arkansas

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FDA Process Registration Forms

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

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FDA Process Registration Form 2541; Food Canning Establishment Registration

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Form 2541 is required to register a processing plant location. Any plant Form 2541 is required to register a processing plant location. Any plant processing canned foods under 21 CFR 108, 113 and 114 must processing canned foods under 21 CFR 108, 113 and 114 must register their plant with FDA.register their plant with FDA.

A. Obtaining forms.A. Obtaining forms.

1. Launch your internet browser and go to “www.fda.gov”.1. Launch your internet browser and go to “www.fda.gov”.

2. Under “Products FDA Regulates”, click on Food.2. Under “Products FDA Regulates”, click on Food.

3. Under “Program Areas”, click on “Acidified and Low 3. Under “Program Areas”, click on “Acidified and Low Acid Acid Canned Canned Foods”.Foods”.

4. Under “Registration, Process Filing Forms, 4. Under “Registration, Process Filing Forms, Instructions and Instructions and Guidelines” click on PDF and Guidelines” click on PDF and download “Food Canning download “Food Canning Establishment Establishment Registration FDA 2541" as an Adobe® Registration FDA 2541" as an Adobe® Acrobat® Acrobat® document. You must have Adobe® Acrobat® document. You must have Adobe® Acrobat® Reader Reader

5.0 to read the document.5.0 to read the document.

5. 2541 is also available from the FDA as a complete pack 5. 2541 is also available from the FDA as a complete pack with with built-in carbons.built-in carbons.

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B. Filling Out FormsB. Filling Out Forms

1. Print all four pages of Form 2541. 1. Print all four pages of Form 2541.

2. Detailed directions for registering your plant are 2. Detailed directions for registering your plant are available from the FDA at their website:available from the FDA at their website:

http://www.cfsan.fda.gov/~comm/lacf-s2.html

3. For FDA Use Only Section:3. For FDA Use Only Section: Make no mark in this section.Make no mark in this section.

4. Type of Submission:4. Type of Submission: Check "Initial Registration" if this Check "Initial Registration" if this processing plant has never been registered before. Leave processing plant has never been registered before. Leave

the the space for "Current FCE" number blank.space for "Current FCE" number blank.

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Check “Relocation (new registration Required) If a previously registered Check “Relocation (new registration Required) If a previously registered establishment has moved to a new location. Enter your current Food Canning establishment has moved to a new location. Enter your current Food Canning Establishment (FCE) number in the space provided. Complete all other spaces 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 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 return a copy of the form as for a new registrant. The old FCE is invalid and may not be used.may not be used.

Check "Change of Registration Information" if you are submitting changes such as Check "Change of Registration Information" if you are submitting changes such as

the following for a previously registered firm:the following for a previously registered firm: * Change in firm name* Change in firm name

* Change in mailing address* Change in mailing address * Change in ownership* Change in ownership

* Change in postal address because of renaming of street, * Change in postal address because of renaming of street, renumbering of building, etc. (no actual change in renumbering of building, etc. (no actual change in location).location).

Enter the type of change and the current FCE number in the space provided.Enter the type of change and the current FCE number in the space provided.

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5. Food Processing Plant Location: 5. Food Processing Plant Location: Give name of the processor and the Give name of the processor and the address of the physical location of the processing operation. Do not address of the physical location of the processing operation. Do not

give a Post Office Box number.give a Post Office Box number.

6. Preferred Mailing Address: 6. Preferred Mailing Address: If mailing address is the same as the plant If mailing address is the same as the plant location check the “Same as Plant Locatiom” Box. Otherwise givelocation check the “Same as Plant Locatiom” Box. Otherwise give

office address information.office address information.

7. Low Acid and/or Acidified Foods Processed at This Location. 7. Low Acid and/or Acidified Foods Processed at This Location. List all List all products produced and whether they are low acid or acidified.products produced and whether they are low acid or acidified.

8. Please Send the Following: 8. Please Send the Following: FDA will provide forms for filing. Fill in the FDA will provide forms for filing. Fill in the number of each form needed.number of each form needed.

9. Leave no blank spaces on the form. It will be sent back to you for 9. Leave no blank spaces on the form. It will be sent back to you for clarification.clarification.

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10. 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 ParkwayCollege Park, MD 20740-3835

11. Your Food Canning Establishment (FCE) number will be sent to you.

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

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A. Obtaining forms.A. Obtaining forms.

1. Launch your internet browser and go to “www.fda.gov”.1. Launch your internet browser and go to “www.fda.gov”.

2. Under “Products FDA Regulates”, click on Food.2. Under “Products FDA Regulates”, click on Food.

3. Under “Program Areas”, click on “Acidified and Low Acid Canned Foods”.3. Under “Program Areas”, click on “Acidified and Low Acid Canned Foods”.

4. Under “Registration, Process Filing Forms, Instructions and Guidelines” 4. Under “Registration, Process Filing Forms, Instructions and Guidelines” click on PDF and download “Process Food click on PDF and download “Process Food Canning Establishment Filing Canning Establishment Filing for All Methods Except Low Acid Aseptic FDA 2541a" as an Adobe® for All Methods Except Low Acid Aseptic FDA 2541a" as an Adobe® Acrobat® document. You must have Adobe® Acrobat® Reader 5.0 to read Acrobat® document. You must have Adobe® Acrobat® Reader 5.0 to read the document.the document.

5. Print both pages of Form 2541a5. Print both pages of Form 2541a

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6. 2541a is also available from the FDA as a complete pack with 6. 2541a is also available from the FDA as a complete pack with built-in carbons. built-in carbons.

B. Filling out formsB. Filling out forms

1 Detailed directions for filing a process are available from the 1 Detailed directions for filing a process are available from the FDA at their website.FDA at their website.

http://www.cfsan.fda.gov/~comm/lacf-s3.htmlhttp://www.cfsan.fda.gov/~comm/lacf-s3.html

2. The services of a Processing Authority may be required to 2. The services of a Processing Authority may be required to determine safe processes for low acid canned foods.determine safe processes for low acid canned foods.

3. The University of Arkansas Institute of Food Science and 3. The University of Arkansas Institute of Food Science and Engineering can assist with process determination for high acid or Engineering can assist with process determination for high acid or acidified foods.acidified foods.

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4. Section A: Product4. Section A: Product

a. Name, Form or Style, and Packing Medium.a. Name, Form or Style, and Packing Medium. Describe the Describe the product, i.e. Green beans (cut) in brineproduct, i.e. Green beans (cut) in brine

b. pH before acidification.b. pH before acidification. Enter the pH. ( e.g. 10.2 ).Enter the pH. ( e.g. 10.2 ).

c. Governing Regulation.c. Governing Regulation. Check either low-acid or acidified Check either low-acid or acidified depending upon the process to be used.depending upon the process to be used.

d. Type of Submission.d. Type of Submission. Check either “new” or “replaces” and Check either “new” or “replaces” and give date of process replaced or “cancels” and give date of give date of process replaced or “cancels” and give date of

process canceled.process canceled.

e. Process Use.e. Process Use. Check “scheduled” for process to be used in Check “scheduled” for process to be used in plant or “alternate for” and give date of the process for plant or “alternate for” and give date of the process for which which

this is an alternate or “emergency for” and give date this is an alternate or “emergency for” and give date of process of process for which this is for which this is an emergency filing.an emergency filing.

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d. FCE.d. FCE. Enter Food Canning Establishment number.Enter Food Canning Establishment number.

e. SID.e. SID. Enter Submission Identifier. Enter date as YYYY-MM-DD. Enter Submission Identifier. Enter date as YYYY-MM-DD. SSS is the number of the submission if more than one SSS is the number of the submission if more than one were made were made on a given date, ( e.g. 002 ).on a given date, ( e.g. 002 ).

5.5. Section B. Processing MethodSection B. Processing Method

a. Name of Sterilizer (Mfg and Type)a. Name of Sterilizer (Mfg and Type) ( e.g. FMC Sterimatic ) ( e.g. FMC Sterimatic )

b. Heating Medium (e.g., Steam, water, immersion or spray, steam-b. Heating Medium (e.g., Steam, water, immersion or spray, steam-air)air) Describe the method of heating in the retort.Describe the method of heating in the retort.

c. Select type of retort.c. Select type of retort. Check the box which identifies the type of Check the box which identifies the type of retort. If 21 CFR 108.25 and 114 was marked as the retort. If 21 CFR 108.25 and 114 was marked as the

governing regulation, process is for an acidified food, check governing regulation, process is for an acidified food, check “Acidified” “Acidified” and list the pH, Method of Acidification, and list the pH, Method of Acidification, Acidifying Agent, Acidifying Agent, Pasteurization Pasteurization Method, Preservatives Used Method, Preservatives Used and Concentrations.and Concentrations.

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d. Container Type.d. Container Type. Select the box which describes the container Select the box which describes the container being used.being used.

e. Process Establishment Source.e. Process Establishment Source. This may be a standard reference This may be a standard reference such as NFPA Handbook 26L or from a Processing such as NFPA Handbook 26L or from a Processing

Authority.Authority.

f. Date Last Established.f. Date Last Established. Give most recent date of process from Give most recent date of process from Process Establishment Source.Process Establishment Source.

g. Process Recommendations Attached?g. Process Recommendations Attached? This is not required but This is not required but clarification but may be requested by FDA. clarification but may be requested by FDA.

Recommendations and data of a Processing Authority should be Recommendations and data of a Processing Authority should be attached if it attached if it is deemed necessary to support the process data.is deemed necessary to support the process data.

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6. 6. Section C: Critical FactorsSection C: Critical Factorsa. Critical Factors are items whose variance will have a a. Critical Factors are items whose variance will have a

potential potential to cause underprocessing and Public Health to cause underprocessing and Public Health dangers.dangers.

b. All products must be evaluated by a Processing Authority b. All products must be evaluated by a Processing Authority to to determine Critical Factors.determine Critical Factors.

c. Every product will not have all the Critical Factors listed c. Every product will not have all the Critical Factors listed in in Section C. Those that are found to apply to a specific Section C. Those that are found to apply to a specific

product must be identified and steps taken to assure product must be identified and steps taken to assure compliance. compliance.

Page 2. Scheduled ProcessPage 2. Scheduled Processa. Enter FCEa. Enter FCE (Food Canning Establishment)(Food Canning Establishment) and SIDand SID

(Submission Identifier)(Submission Identifier)..b. Container Dimensions.b. Container Dimensions.

1. Cont. No.1. Cont. No. The product described on the first The product described on the first page page may be packed in any number of sizes of may be packed in any number of sizes of

container. Each different container must be container. Each different container must be given a container number.given a container number.

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2. Diameter or Length.2. Diameter or Length. Give the diameter of the can in inches Give the diameter of the can in inches and sixteenths ( e.g. 603). For other packages give and sixteenths ( e.g. 603). For other packages give longest dimension as length in inches and longest dimension as length in inches and sixteenths.sixteenths.

3. Height or Width.3. Height or Width. Give the height of the can in inches and Give the height of the can in inches and sixteenths ( e.g. 700 ). For other packages give shorter sixteenths ( e.g. 700 ). For other packages give shorter dimension as width in inches and sixteenths.dimension as width in inches and sixteenths.

4. Height of Maximum Pouch or Semi-rigid Container Thickness.4. Height of Maximum Pouch or Semi-rigid Container Thickness. Lay container on a flat surface and measure maximumLay container on a flat surface and measure maximum

height in inches and sixteenths.height in inches and sixteenths.

c. Capacity Units.c. Capacity Units. Check box to indicate units ( e.g. oz.). Place Check box to indicate units ( e.g. oz.). Place capacity on line for each size.capacity on line for each size.

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d. Scheduled Process (Check Only One in Each Column). d. Scheduled Process (Check Only One in Each Column).

1. Step No.1. Step No. Enter 1 unless multi-shell retort or hydostatic retort Enter 1 unless multi-shell retort or hydostatic retort is used. Then each shell is a separate step. Some is used. Then each shell is a separate step. Some

hydrostatic hydrostatic retorts will have multiple steps.retorts will have multiple steps.

2. Temp (°F).2. Temp (°F). Mark Check Box for appropriate data. Check Mark Check Box for appropriate data. Check minimum initial temperatureminimum initial temperature (Min IT)(Min IT) for Low Acid for Low Acid Canned FoodCanned Food (LACF),(LACF), or minimum initial temperatureor minimum initial temperature

(Min (Min IT)IT) or Fill or Center temperatures for Acidified or aor Fill or Center temperatures for Acidified or aww Controlled. Check N/A if Controlled. Check N/A if not applicable. Enter not applicable. Enter

temperature temperature in whole °F ( e.g. 110 ) in table on correct line.in whole °F ( e.g. 110 ) in table on correct line.

3. Process Time (Minutes).3. Process Time (Minutes). For Low Acid Canned FoodFor Low Acid Canned Food (LACF)(LACF) mark check box formark check box for Process Time.Process Time. ForFor Acidified or aAcidified or aww Controlled check Process Time, or Hold Time.Controlled check Process Time, or Hold Time. Enter time Enter time

in in hundredths of minutes ( e.g. 010.90 ).hundredths of minutes ( e.g. 010.90 ).

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4. Sterilization Temp (°F).4. Sterilization Temp (°F). For Low Acid Canned Food For Low Acid Canned Food (LACF)(LACF) mark check box for mark check box for Process Temp.Process Temp. For For Acidified Acidified

or aor aww ControlledControlled check check Process Temp. or N/AProcess Temp. or N/A. Enter . Enter TemperatureTemperature to nearest whole °F ( e.g. 248 ) in table on correct to nearest whole °F ( e.g. 248 ) in table on correct line.line.

5. Least Sterilizing Value of the Scheduled Process.5. Least Sterilizing Value of the Scheduled Process. Mark Mark Check box forCheck box for FF00 (Equivalent Minutes at 250°F) or(Equivalent Minutes at 250°F) or Other Other F ValueF Value. . If If Other F ValueOther F Value is marked, list is marked, list Death Rate (z)Death Rate (z) andand Ref. Temp. (T)Ref. Temp. (T) used to calculate value.used to calculate value. CheckCheck IS ValueIS Value

if if Integrated Sterilization Value computer programs were Integrated Sterilization Value computer programs were used. used. CheckCheck OtherOther if an if an equivalent scientific method is used. equivalent scientific method is used.

Identify the method on the Identify the method on the line by the box. Enterline by the box. Enter F F00 in tenths of units ( e.g. 10.9 ).in tenths of units ( e.g. 10.9 ).

e. Other Critical Factors to Assure Commercial Sterility Per Source Authoritye. Other Critical Factors to Assure Commercial Sterility Per Source Authority

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1. Thruput.1. Thruput. For rotary or continuous retorts, thruput is the number of For rotary or continuous retorts, thruput is the number of containers processed per minute. For still retorts mark the containers processed per minute. For still retorts mark the N/A N/A check check box.box.

2. Headspace. Net Head space2. Headspace. Net Head space is the distance from the can end to the solid is the distance from the can end to the solid product level. product level. Gross Head spaceGross Head space is the distance from the can end to the is the distance from the can end to the brine or syrup. For still retorts head space is not important, but for 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 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 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. check box and enter the head space in ten-thousandths of an inch ( e.g. .0375 )..0375 ).

3. Speed.3. Speed. For still retorts checkFor still retorts check N/A.N/A. For rotary and orbital recordFor rotary and orbital record Reel Reel SpeedSpeed in in hundredths of an RPM ( e.g. 012.92 );hundredths of an RPM ( e.g. 012.92 ); Reel DiameterReel Diameter to the to the nearest inch ( e.g. nearest inch ( e.g. 048 ) and048 ) and Steps per Turn of ReelSteps per Turn of Reel by actual count of by actual count of container position in a reel container position in a reel ( e.g. 064 ). For hydrostatic retorts record( e.g. 064 ). For hydrostatic retorts record Chain/Conveyer SpeedChain/Conveyer Speed inin Feet, Feet, Carriers or Flights per MinuteCarriers or Flights per Minute in in hundredths ( e.g. 022.45 ) and mark the hundredths ( e.g. 022.45 ) and mark the correct check boxcorrect check box

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4. Maximum Weight.4. Maximum Weight. For some processes the amount of product in the For some processes the amount of product in the container is a critical factor. Some processes may state the uncooked fill container is a critical factor. Some processes may state the uncooked fill weight and others may state the post cook drained weight. Mark the weight and others may state the post cook drained weight. Mark the correct check box. Record thecorrect check box. Record the Maximum WeightMaximum Weight in hundredths of an in hundredths of an ounce ( e.g. 08.25 ). If not a factor, check ounce ( e.g. 08.25 ). If not a factor, check N/A.N/A.

5. Minimum Net Weight.5. Minimum Net Weight. For some processes a minimum amount of For some processes a minimum amount of fill fill is is required to achieve proper heat transfer. Record therequired to achieve proper heat transfer. Record the Minimum Minimum WeightWeight in hundredths of an ounce ( e.g. 18.35 ). If not a factor, checkin hundredths of an ounce ( e.g. 18.35 ). If not a factor, check N/A. N/A.

6. Minimum Free Liquid at Closing.6. Minimum Free Liquid at Closing. For vacuum pack processes only, enter For vacuum pack processes only, enter the minimum free liquid in the container (in ounces) at closing. the minimum free liquid in the container (in ounces) at closing.

Express Express to the nearest tenth (e.g., 01.3). If not applicable, checkto the nearest tenth (e.g., 01.3). If not applicable, check N/A.N/A.

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7. Minimum Container Closing Machine Gauge Vacuum.7. Minimum Container Closing Machine Gauge Vacuum. For vacuum For vacuum pack processes only, enter minimum container closing machine gauge pack processes only, enter minimum container closing machine gauge vacuum if specified by the process source to be critical. Express in whole 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 inches of mercury (Hg). In the column heading, enter the temperature at which measured If not applicable, checkwhich measured If not applicable, check N/A.N/A.

8. Other ( Specify ).8. Other ( Specify ). Factors not previously listed which affect the process Factors not previously listed which affect the process can be specified in this sectioncan be specified in this section. .

f. Comments.f. Comments. Use this section to make notes which will clarify any listing on the Use this section to make notes which will clarify any listing on the form.form.

g.g. Plant Name/Address.Plant Name/Address. Enter the physical address of the plant which Enter the physical address of the plant which corresponds to the FCE number on this form.corresponds to the FCE number on this form.

h. Preferred Mailing Address.h. Preferred Mailing Address. Enter the mailing address if used.Enter the mailing address if used.

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i.i. Authorized Individual.Authorized Individual. Print (or type) the Full Name of the Print (or type) the Full Name of the authorized representative who is signing this form on behalf of the authorized representative who is signing this form on behalf of the company and the telephone Number at which he can be company and the telephone Number at which he can be reached. Sign reached. Sign and date the form. If someone other than an employee or officer of your 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 signs the form, FDA must have on file, a letter from your company authorizing this person or organization to act on your behalf.company authorizing this person or organization to act on your behalf.

j. The pink copy of all filings must be retained in the plant.j. The pink copy of all filings must be retained in the plant.

k.k. Mail the original form to:Mail the original form to:

LACF Registration Coordinator (HFS-618)LACF Registration Coordinator (HFS-618)Center for Food Safety and Applied Nutrition (FDA)Center for Food Safety and Applied Nutrition (FDA)5100 Paint Branch Parkway5100 Paint Branch ParkwayCollege Park, MD 20740-3835College Park, MD 20740-3835

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Produced and narrated by Jim GoffFor further information contact:

Jim GoffUniversity of ArkansasInstitute of Food Science and Engineering2650 N. Young AvenueFayetteville, AR 72704(479) 575-3095 FAX (479) 575-2165jgoff@uark.edu

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