Low-Acid Foods Packaged in 
Hermetically Sealed Containers (LACF) 
Regulation and the  
FDA Food Safety Modernization Act:  
Guidance for Industry 
 
 
Additional copies are available from:  
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD  20740 
(tel) 240 402-1700 
http://www.fda.gov/FoodGuidances 
  
 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to http://www.regulations.gov.  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 docket number FDA-2017-D-3716. 
 
 
U.S. Department of Health and Human Services  
Food and Drug Administration  
Center for Food Safety and Applied Nutrition  
 
 
 
December 2021 
    Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
 
I. Introduction ................................................................................................................................. 3 
II. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls 
for Human Food ....................................................................................................................... 4 
III. Foreign Supplier Verification Program (FSVP) ....................................................................... 8 
IV. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption ............................................................................................................................ 9 
V. Mitigation Strategies to Protect Food Against Intentional Adulteration (IA)  21 CFR Part 
121 ........................................................................................................................................... 9 
VI. Sanitary Transportation of Human and Animal Food ............................................................ 10 
 
 
   
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  Contains Nonbinding Recommendations 
 
Low-Acid Foods Packaged in 
Hermetically Sealed Containers (LACF) 
Regulation and the FDA Food Safety 
Modernization Act: Guidance for 
Industry1 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. To discuss an alternative approach, contact FDAs Technical 
Assistance Network by submitting the form available at https://www.fda.gov/food/food-safety-
modernization-act-fsma/fsma-technical-assistance-network-tan. 
 
 
I. Introduction 
 
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the FDA to better 
protect public health by helping to ensure the safety and security of the food supply.  It requires 
FDA to promulgate food safety rules that focus on preventing food safety issues rather than 
relying on detecting issues and reacting to them after they occur. 
 
FSMA recognizes that FDA has previously established a regulation that addresses biological 
hazards unique to low-acid foods packaged in hermetically sealed containers (i.e., low-acid 
canned foods, hereinafter referred to as LACF) 2 (Title 21, Code of Federal Regulations (21 
CFR) part 113). See FSMA  103(a), 103(f), 105(d), and 301 ( 418(j) and 805(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C.  350g(j), 350g note, 350h note, and 
384a(e))).    
 
Importantly, several of the regulations that FDA has issued under FSMA provide exemptions 
that are related to the LACF requirements in part 113.  This guidance, first issued in August 
 
1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied 
Nutrition at the U.S. Food and Drug Administration. 
2 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. 
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2017, addresses those exemptions,3 and also provides information about the LACF regulation in 
part 113 in connection with the following FSMA regulations:   
 
  21 CFR part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food (the CGMP & PC Regulation)  
  21 CFR 1, subpart L, Foreign Supplier Verification Programs for Importers of Food for 
Humans and Animals (the FSVP Regulation) 
  21 CFR 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption (the PS Regulation) 
  21 CFR part 121, Mitigation Strategies To Protect Food Against Intentional Adulteration 
(the IA Regulation) 
  21 CFR 1, subpart O, Sanitary Transportation of Human and Animal Food (the ST 
Regulation) 
 
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law.  FDAs 
guidance documents, including this guidance, should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited.  The use of the word should in Agency 
guidances means that something is suggested or recommended, but not required. 
 
II. Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Human Food  
 
The CGMP & PC regulation contains 7 subparts which address key areas associated with a 
comprehensive food safety program.  Below is a brief summary of the content of each subpart: 
 
Subpart A:  General Provisions 
This subpart provides definitions, identifies exemptions, defines applicability of 
subparts, and specifies training requirements. 
 
Subpart B:  Current Good Manufacturing Practice 
Subpart B contains most of the provisions previously in 21 CFR part 110.  The 
changes include modifications that either delete or make previously recommended 
practices into requirements and provide explicit regulatory text to address allergen 
cross-contact. 
 
Subpart C:  Hazard Analysis and Risk-Based Preventive Controls 
Subpart C describes the requirements for a food safety plan, including hazard 
analyses and preventive controls for facilities subject to this subpart.  
 
Subpart D: Modified Requirements 
 
3 Acidified foods subject to Title 21, Code of Federal Regulations (21 CFR part 114) are subject to the FSVP 
regulation, the CGMP & PC regulation, and the IA regulation.  
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Subpart D describes the modified requirements for qualified facilities and 
facilities solely engaged in the storage of unexposed packaged food (for food that 
requires time/temperature control for safety). 
 
Subpart E:  Withdrawal of a Qualified Facility Exemption 
Subpart E addresses the withdrawal of a qualified facility exemption and the 
appeal and reinstatement procedures.  
 
Subpart F:  Requirements Applying to Records that must be Established and Maintained 
Subpart F establishes the requirements that apply to all subparts for the records 
required to be kept. 
 
Subpart G:  Supply-Chain Program 
Subpart G requires the establishment of written risk-based supply-chain programs 
for receiving facilities (manufacturers/processors) for raw materials and other 
ingredients when a hazard associated with the raw material or other ingredient has 
been controlled before receipt.  It further describes the requirements for supply-
chain programs, supplier verification activities, and recordkeeping for those 
programs. 
 
Subpart A  General Provisions 
 
1.  Are manufacturers of LACF subject to the Current Good Manufacturing Practice 
and Preventive Controls Regulation (21 CFR Part 117)? 
 
Manufacturers of low-acid canned foods must meet the requirements of specific subparts 
of the CGMP & PC Regulation.  The exemption in 21 CFR 117.5(d) of subpart A applies 
to the activities that are subject to 21 CFR part 113.  21 CFR 117.5(d) specifically 
exempts the processing activities of processors of low-acid canned foods from the 
requirements of part 117 subpart C, Hazard Analysis and Risk-Based Preventive 
Controls, and subpart G, Supply-Chain Program for biological hazards and their controls, 
if the processor of low-acid canned foods is in compliance with 21 CFR part 113.  Low-
acid canned food processors still must meet the requirements of part 117 subparts A, B, 
and F (for the records required by subpart A).  In contrast to manufacturers of low-acid 
canned foods, food processors subject to 21 CFR part 114, Acidified Foods, are not 
specifically exempt from any provisions of 21 CFR part 117 and must comply with all 
applicable sections.    
 
Note that manufacturers subject to 21 CFR part 123, Fish and Fishery Products or 21 
CFR part 120, Hazard Analysis and Critical Control Point (HACCP) Systems (Juice 
HACCP) may also be subject to the LACF regulation in 21 CFR part 113. 
 
2.  What if the facility is not in compliance with 21 CFR part 113? 
 
We expect that situations in which enforcement actions to ensure compliance with 21 
CFR part 113 are insufficient to correct problems, and lead to a facility losing its 
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  Contains Nonbinding Recommendations 
 
exemption from the requirements of subparts C and G, will be rare and will depend on 
very specific circumstances.  
 
In general, the appropriate action for us to take when a facility is out of compliance with 
the LACF regulation in 21 CFR part 113 will be to employ existing enforcement tools to 
bring the facility into compliance with that regulation.  
 
However, there may be circumstances where an added food safety benefit could be 
achieved by requiring compliance with the CGMP & PC regulation when a facility does 
not comply with the LACF regulation in 21 CFR part 113. 
 
3.  Which definitions apply to manufacturers of LACF? 
 
With respect to any microbiological hazard and its corresponding control, the definitions 
found in 21 CFR part 113 apply.  Definitions found in 21 CFR part 117 apply to all other 
relevant requirements of that regulation.  
 
4.  What additional training requirements apply to manufacturers of LACF under 21 
CFR part 117? 
 
Manufacturers of LACF are required to comply with the new training requirements in 21 
CFR 117.4, which requires that individuals engaged in manufacturing, processing, 
packing, or holding food (including temporary and seasonal personnel) and  the 
supervisors who oversee their activities (1) be a qualified individual as defined in 21 CFR 
117.3, i.e., have the combination of education, training, and/or experience necessary to 
manufacture, process, pack, or hold clean and safe food as appropriate to the individuals 
assigned duties (21 CFR 117.4(b)(1)); and (2) receive training in the principles of food 
hygiene and food safety, including the importance of employee health and personal 
hygiene, as appropriate to the food, the facility, and the individuals assigned duties (21 
CFR 117.4(b)(2)).  Manufacturers of LACF must establish and maintain records that 
document training required in the principles of food hygiene and food safety in 
accordance with requirements in 21 CFR part 117 subpart F (21 CFR 117.4(d)).   
 
In addition to the above requirements, the LACF regulation (21 CFR 113.10) contains a 
training requirement applicable to a person providing operating supervision under the 
LACF regulation.   
 
Subpart B  Current Good Manufacturing Practices 
 
5.  Are the Current Good Manufacturing Practices provisions in 21 CFR part 117 
different from those in 21 CFR part 110? 
 
The CGMP requirements in 21 CFR part 117 (mostly in subpart B) generally align with 
the requirements of 21 CFR part 110, with the non-binding provisions in 21 CFR part 110 
removed or made binding.   In addition, 21 CFR part 117 subpart B addresses allergen 
cross-contact explicitly in the regulatory text. In addition, training, which was 
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  Contains Nonbinding Recommendations 
 
recommended in 21 CFR part 110, is now mandated in 21 CFR part 117 subpart A (refer 
to question 4). 
 
6.  What procedures and controls does FDA require manufacturers of LACF to have 
and implement to control allergen cross-contact? 
 
Food allergens, which are considered chemical hazards and thus are not covered by the 
LACF exemption at 21 CFR 117.5(d), are specifically addressed in 21 CFR part 117 
Subpart C as a hazard that must be addressed in the food safety plan (21 CFR 117.135).  
If a low acid canned food processor identifies food allergens as a hazard they must 
establish preventive controls (21 CFR 117.135(c)(2)).  
 
Subpart C  Hazard Analysis and Risk-Based Preventive Controls 
 
7.  Does 21 CFR part 117 require manufacturers of LACF to have written sanitation 
controls? 
 
Written sanitation controls for microbiological hazards are not required because 
manufacturers of LACF are exempt from subpart C with regard to microbiological 
hazards regulated under part 113 (21 CFR 117.5(d)).  However, sanitation controls may 
be required to prevent cross contact if the firm has identified food allergen hazards. 
8.  Are manufacturers of LACF required to collect and test environmental samples? 
 
No.  Manufacturers of LACF are not required to do environmental monitoring because 
they are exempt from subpart C with regard to microbiological hazards that are regulated 
under part 113 (21 CFR 117.5(d)).  
 
Subparts D and E  Modified Requirements and Withdrawal of a Qualified Facility 
Exemption 
 
9.  Can manufacturers of LACF be a qualified facility? 
 
Yes, if a manufacturer of LACF has identified chemical or physical hazards and they 
meet the requirements for a qualified facility then the qualified facility exemption in 
21 CFR 117.5(a) may apply; they would be subject to the modified requirements in 21 
CFR 117.201.  Any applicable exemption in part 117 does not relieve a manufacturer 
from compliance with 21 CFR part 113. 
 
Subpart F - Requirements Applying to Records that must be Established and Maintained 
 
10. Do the records requirements listed in 21 CFR part 117 subpart F apply to 
manufacturers of LACF? 
 
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Yes, the record keeping requirements in 21 CFR part 117 subpart F apply to 
manufacturers of LACF with respect to applicable preventive controls (physical and 
chemical hazards), as well as to training records required by 21 CFR 117.4(d)(2).  
 
Subpart G  Supply-Chain Program 
 
11. Does subpart G apply to manufacturers of LACF raw materials and ingredients? 
 
If a manufacturer of LACF identifies non-biological (i.e., chemical or physical) hazards 
associated with raw materials and ingredients received by the facility and the hazards are 
controlled by the supplier, the manufacturer would be subject to the requirements for a 
supply-chain program as required by subpart G. 
 
III. Foreign Supplier Verification Program (FSVP) 
 
The, Foreign Supplier Verification Programs for Food Importers of Foods for Humans and 
Animals (FSVP) regulation, is in subpart L of part 1 of FDAs regulations (21 CFR 1.500-1.514).  
The FSVP regulation requires importers to create and follow procedures to ensure the safety of 
the food they import.   
 
12. How does FSVP impact my importation of LACF? 
 
Importers of LACF not subject to further manufacturing and processing, and subject to 21 
CFR part 113, are subject to the FSVP Regulation (21 CFR part 1, subpart L (21 CFR 
1.500-1.514)).  See 21 CFR 1.502(b)(1). 
 
With respect to microbiological hazards that are controlled by part 113, importers of 
LACF must verify that their suppliers produced the LACF products in accordance with 
part 113.  With respect to non-biological hazards (i.e., chemical and physical hazards) in 
these products, importers of LACF must have an FSVP in accordance with the FSVP 
regulation. 
 
13. How does FSVP affect my importation of raw materials or other ingredients used in 
LACF? 
 
With respect to microbiological hazards that are controlled by part 113, importers are not 
required to comply with the FSVP regulation for raw materials or other ingredients that 
the importer uses in the manufacturing or processing of LACF provided that the importer 
is in compliance with part 113 with respect to the LACF manufactured or processed from 
the imported raw materials or other ingredients.  See 21 CFR 1.502(b)(2).  With respect 
to all hazards other than microbiological hazards, the importer must have an FSVP for the 
imported raw materials and other ingredients that the importer uses in the manufacture or 
processing of LACF.  Thus, if an importer of raw materials used in the production of 
LACF complies with part 113 in making LACF products using the imported raw 
materials, the importer must have an FSVP for the chemical or physical hazards 
associated with the raw materials or other ingredients, but the FSVP does not need to 
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address microbiological hazards that are controlled under part 113. (See 21 CFR 
1.502(b)(2).)  
 
IV. Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption 
 
14. Must an LACF processor purchase produce that was produced in compliance with 
21 CFR Part 112? 
 
No.  21 CFR part 112 applies only to certain farms and their produce.  It does not apply 
to activities of LACF processors subject to 21 CFR part 113.  For farms and their produce 
that would otherwise be subject to part 112, produce that receives commercial processing 
that adequately reduces the presence of microorganisms of public health significance is 
eligible for an exemption from part 112 (21 CFR 112.2(b)(1)).  Processing in accordance 
with the requirements of 21 CFR part 113 are examples of processing that adequately 
reduces the presence of microorganisms of public health significance for purposes of this 
exemption.  However, for the produce to qualify for the exemption from part 112, the 
farmer must disclose in documents accompanying the produce that the food is not 
processed to adequately reduce the presence of microorganisms of public health 
significance (21 CFR 112.2(b)(2)).  To qualify for the exemption, the farmer must also 
obtain written assurance annually from the customer (e.g., the LACF operation) that 
performs the commercial processing that the customer has established and is following 
procedures (identified in the written assurance) that adequately reduce the presence of 
microorganisms of public health significance or that an entity subsequent to it in the food 
chain will do so (and in such cases, the farmer must also obtain certain additional 
assurances from the customer) (21 CFR 112.2(b)(3)).  The compliance date for such 
written assurances has been extended (see 81 FR 57784 at 57786).   
 
V. Mitigation Strategies to Protect Food Against Intentional 
Adulteration (IA)  21 CFR Part 121 
 
15. Must a manufacturer of LACF also comply with 21 CFR Part 121  Mitigation 
Strategies to Protect Food Against Intentional Adulteration? 
 
Domestic and foreign LACF manufacturers required to register with FDA (21 USC 350d) 
must comply with 21 CFR Part 121 unless an exemption applies to the facility.  Facilities 
must be in compliance by the dates established by the IA final regulation. 
 
  The IA regulation does not apply to a very small business (i.e., a business, including 
any subsidiaries or affiliates, averaging less than $10,000,000, adjusted for inflation, 
per year, during the 3-year period preceding the applicable calendar year in both sales 
of human food plus the market value of human food manufactured, processed, 
packed, or held without sale, e.g., held for a fee), except that the facility is required to 
provide for official review, upon request, documentation sufficient to show that the 
facility qualifies for this exemption. 
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  This regulation does not apply to the holding of food, except the holding of food in 
liquid storage tanks. 
  This regulation does not apply to the packing, re-packing, labeling, or re-labeling of 
food where the container that directly contacts the food remains intact. 
  This regulation does not apply to activities of a farm that are subject to section 419 of 
the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety). 
  This regulation does not apply to the manufacturing, processing, packing, or holding 
of food for animals.   
 
See 21 CFR 121.5 for exemptions.   
 
VI. Sanitary Transportation of Human and Animal Food  
 
16. Is the shipment of LACFs covered under the Sanitary Transportation of Human 
and Animal Food regulation? 
 
Transportation operations for food completely enclosed by a container are not subject to 
the ST regulation unless the food requires temperature control for safety. LACFs 
packaged in hermetically sealed containers are thus not subject to this regulation. 
 
 
 
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