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U.S. Food SafetyAGS-16-033

U.S. Low-Acid Canned Foods Management System (21 CFR 113 & 108.35)

U.S. Low-Acid Canned Foods Management System (21 CFR 113 & 108.35)

An editable documentation system for U.S. plants that make thermally processed low-acid foods in hermetically sealed containers, built around 21 CFR Part 113 and the registration and process filing rules of 21 CFR 108.35.

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235 ready-to-use documents 234 Word · 1 Excel · plus the AGS license · 1 support file

By document type

Total 235
CategoryFiles
Manuals1
Policies2
Procedures & SOPs12
Plans & Programmes31
Forms & Records20
Checklists & Audit Tools42
Registers, Logs & Matrices6
Training & Awareness34
Guides & Work Instructions27
Tools & Workbooks1
Other Documents59

Key documents

ReferenceDocumentFormat
LACF-MAN-001U.S. Low-Acid Canned Foods Food Safety Manual Word
LACF-PROC-002Scheduled Process Control Program Word
LACF-THERM-001LACF Thermal Process Control Program Word
LACF-PROC-010Double Seam Inspection & Control Procedure Word
LACF-022Thermal Process Record Word
LACF Master Workbook Excel

Overview

A low-acid canned food is safe only if its scheduled process is right and is followed every time. Is the product really low-acid? Is the establishment registered and the process filed? Who is the process authority, and what happens when a retort deviates? This system puts the answers in writing.

It starts with classification, separating low-acid canned foods from acidified, acid, refrigerated and frozen products, then assesses how Part 113, Part 108 and 21 CFR Part 117 apply, with the 21 CFR 117.5(d) exemption explained. The documents do not set scheduled processes or supply thermal values. Those come from your process authority, and the system records them.

The files reference 21 CFR Part 113 and 21 CFR 108.35 as shown on the eCFR at the end of August 2026. Binding text is kept apart from FDA guidance, and HACCP is a voluntary layer. AGS is independent and is not affiliated with the FDA or USDA FSIS. Regulations are referenced by citation, and no regulation text is included.

What this system covers

  • Classification and applicability: a product classification decision framework, Part 113 and Part 108 applicability, and a Part 117 applicability assessment.
  • Process authority and scheduled processes: process authority engagement, scheduled process control, critical factors, formula control, and heat distribution and heat penetration study records.
  • Thermal processing: commercial sterility and C. botulinum control, retort operations, and the rule that retort operators work under a person trained at an FDA-recognised school.
  • Container integrity and cooling: double seam, glass and retort pouch procedures, a defect classification programme, and cooling and cooling-water control.
  • Registration and filing: records for establishment registration and process filing on Forms FDA 2541, 2541d, 2541f and 2541g.
  • Deviations and release: deviation handling under 21 CFR 113.89, hold and release, traceability, and recall under 21 CFR 108.35(f).
  • Supporting programmes: sanitation, water, suppliers, allergens, food defence and fraud, calibration, maintenance and change.
  • Models, training and assurance: illustrative HACCP product models, training modules, forms, checklists, an Excel workbook of registers and logs, internal audit, inspection readiness, gap assessment and a 30-day roadmap.

Who it's for

Facilities that manufacture, process, package or hold thermally processed low-acid foods in hermetically sealed containers for the U.S. market: canned vegetables, beans, soups, sauces, ready meals, and retort pouch and tray products. It suits plants that work with a process authority. The canned meat and poultry models flag possible USDA FSIS rules, and the canned seafood model adds 21 CFR Part 123.

For a Codex-style HACCP system for the same product family, see the HACCP Canned & Retort Foods Management System. Acidified products are out of scope here and are covered by the U.S. Acidified Foods Management System (21 CFR 114).

Everything you get

Every toolkit gives you a full set of working documents for your standard, ready to edit and use.

Editable Word and Excel

Native Microsoft files. Add your logo and adapt every document to how you work.

Instant download

Your full toolkit arrives as a ZIP the moment payment clears.

Unlimited users

One purchase covers everyone in your organisation. No per-seat fees.

Written by auditors

Built by people who run real audits, so the content matches what assessors check.

Yours to keep

One payment, perpetual licence for your organisation. No subscriptions, no renewals.

Refund guarantee

Full refund if your files are faulty, incomplete or not as described and we can't put it right

Frequently asked questions

What exactly do I receive?

A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.

Are the documents really editable?

Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.

Does this certify my organisation?

No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.

How is it delivered?

Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.

Do I get updates?

Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.

What is your refund policy?

These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.

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