Guidance for Industry: Dear 
Manufacturer Letter Regarding Changes 
to FDAs Administration of Process 
Filings (Forms FDA 2541a and FDA 
2541c) for Acidified Foods and Low-Acid 
Canned Foods 
Additional copies are available from: 
Office of Food Safety 
Food Processing Evaluation Team, HFS-302 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive
College Park, MD  20740 
(Tel) 240-402-2411 
http://www.fda.gov/FoodGuidances 
You may submit written comments regarding this guidance at any time.  Submit written 
comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  All comments should be 
identified with the title of the guidance document.    
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
January 2014  Contains Nonbinding Recommendations 
 
Guidance for Industry1 
Dear Manufacturer Letter Regarding Changes to FDAs 
Administration of Process Filings (Forms FDA 2541a and FDA 
2541c) for Acidified Foods and Low-Acid Canned Foods  
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance. 
 
 
This letter informs commercial processors of acidified foods (AF) and/or thermally processed 
low-acid foods packaged in hermetically sealed containers (historically referred to as low-acid 
canned foods or LACF) of three administrative changes and one non-substantive technical 
change FDA is making to manage process filing forms.   
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Dear Industry: 
 
The U.S. Food and Drug Administration (FDA or we) has made three administrative changes  to 
the procedures we use to manage the process filing forms2 submitted by commercial processors 
of  acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically 
sealed containers (historically referred to as low-acid canned foods or LACF) 3.  The 
purpose of these administrative changes is to make it easier for us to identify, and know the 
status of, each of your products.  This letter describes these administrative changes.  Most of the 
changes relate to process filings that you submitted using paper forms and do not impact process 
filings that you submitted electronically.  This letter is to directly notify facilities impacted by 
these changes.   
 
                                                 
1 This guidance has been prepared by the Food Processing Evaluation Team in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration. 
2 In the past, the applicable process filing forms were designated as Forms FDA 2541a and FDA 2541c.  We are 
revising the forms and re-naming them as Food Process Filing for Low-Acid Retorted  Method (FDA 2541d), Food 
Process Filing for Acidified Method (FDA 2541e), Food Process Filing for Water Activity/Formulation Control 
Method (FDA 2541f), and Food Process Filing for Low-Acid Aseptic Systems (FDA 2541g). 
3 Although some hermetically sealed containers (e.g., pouches and glass bottles) used to package thermally 
processed low-acid foods generally would not be viewed as cans, the term low-acid canned foods has been used 
for decades as a shorthand description for thermally processed low-acid foods packaged in hermetically sealed 
containers, and we continue to use that term (and its abbreviation, LACF) for the purposes of this document.   
  1  Contains Nonbinding Recommendations 
We also are making one non-substantive technical change to our procedures regarding 
information about container size on process filing forms.   
 
Administrative Changes 
 
The first administrative change relates to those process filings submitted using paper forms that 
identify several container sizes (or volumes) for a product on the same form.  In the past, when 
we received such paper forms we assigned a single Submission Identifier (SID) to all container 
sizes of that product.  Now, however, we will be changing some of those SIDs so that there will 
be a unique SID for each container size of a product.  If this change affects the SIDs associated 
with any of your products, we are sending you the new SIDs that will be used to identify the 
individual products that used to be identified by a single SID.  If you receive new SIDs from us, 
you should refer to those new SIDs in any future correspondence with FDA about these products. 
 
The second administrative change relates to those process filings, submitted using paper forms, 
that you identified as  replacing a SID on file.4  In the past, when we received a process filing 
form that indicated it was replacing an existing SID, we classified the process filing being 
replaced as a replaced SID in our database system.  Now, however, we are classifying a 
process filing being replaced as a cancelled SID and the new SID as a filed SID. This change 
does not affect the status of any of your process filings; it only affects the terminology we assign 
to those process filings in our database system.  We keep a cancelled SID in our active process 
filing database for 3 years and then archive the cancelled SID.  Our active process filing database 
does not recognize an archived SID as being filed.  We are applying these new procedures to 
both newly submitted replacement SIDs and to all replaced SIDs that are presently in our 
system and older than 3 years.  If this change affects the terminology used to refer to any form 
you previously filed with us, we are notifying you about the change.   
 
The third administrative change relates to those process filings, submitted either electronically or 
using paper forms, that you identified as discontinuing or cancelling5 a SID on file.  As with 
a replaced SID, we are now classifying all such process filings as cancelled, keeping them in 
our active process filing database for 3 years, and then archiving them.  Our active process filing 
database does not recognize an archived SID as being filed.  This change does not affect the 
status of any of your process filings; it only affects the terminology we assign to those process 
filings in our database system.  We are applying these new procedures to both newly submitted 
discontinued or cancelled SIDs and to all discontinued or cancelled SIDs that are presently in our 
system and older than 3 years.  If this change affects the terminology used to refer to any form 
you previously filed with us, we are notifying you about the change.  
 
None of these administrative changes to our procedures affects any other information provided 
by your facility on your process filing forms.   
 
Non-substantive Technical Change 
                                                 
4  Section A of Form FDA 2541a and Question No. 4 of FDA 2541c allows commercial processors to indicate 
whether their process filing form replaces an existing SID. 
5 Section A of Form FDA 2541a and Question No. 4 of FDA 2541c allows commercial processors to indicate 
whether their process filing form cancels an existing SID. 
  2  Contains Nonbinding Recommendations 
The non-substantive technical change relates to those submitted process filings that identified 
container dimensions with a fractional value of less than one sixteenth of an inch (e.g., 405 x 301 
x 014.5, where 014.5 reflects a container dimension of 14.5 sixteenths of an inch).  Our system 
will now round down fractional values of less than 0.5 sixteenths of an inch and will round 
up fractional values greater than or equal to 0.5 sixteenths of an inch.  For example, a container 
dimension that was previously represented as 014.5 would be rounded so that it is now 
represented as 015.  This non-substantive technical change for container dimensions does not 
affect any other information provided by your facility on your process filing forms.   
Why You Are Receiving This Letter 
A check mark in one or more of the items listed below identifies the type(s) of changes that have 
affected process filing forms you submitted to us.  Process filing forms attached to your letter 
provide more details about the specific changes.   
 New SIDs for Different Container Sizes or Volumes.  
 Replaced SID(s).   
 Cancelled SID(s).  
 Container Dimension Rounding.   
You do not need to respond to this letter.  
What to Expect  
 In the future, if you use a single paper form for multiple container sizes of a product, we
will contact you with new SIDs for each container size.
 If you submit process filing forms electronically, you will see that a folder previously
named Discontinued will now be called Cancelled.
How to Contact FDA if You Have Questions 
If you have any questions, you may contact us by email directed to LACF@FDA.HHS.GOV or 
by letter addressed to: 
Office of Food Safety  
Food Processing Evaluation Team, (HFS-302) 
Center for Food Safety and Applied Nutrition  
Food and Drug Administration  
5001 Campus Drive
College Park, Maryland 20740-3835 
ATTENTION: LACF MIGRATION 
3  Contains Nonbinding Recommendations 
Sincerely, 
 
 
 
Susan J. Brecher, MBA 
Team Leader, Food Processing Evaluation Team 
Office of Food Safety 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
 
 
  4