USDA Organic Readiness for Processors and Handlers
Confirm who must be certified, keep the organic system plan current and trace every lot back to the last certified operation.
In Short
- Exemptions are narrow.
- Plan for fraud prevention.
- Trace back, keep 5 years.
The Food Processing Operations Guide
Safe changeovers. Right labels. Every lot traceable.
- The rules and the plan
- Supplier to filled tray
- Allergen changeovers and pack checks
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
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The Food Processing Operations Guide
Safe changeovers. Right labels. Every lot traceable.
The USDA National Organic Program rules in 7 CFR Part 205 decide who must be certified to sell, label or represent products as organic, and what certified handlers must plan, prevent and record. The 2023 Strengthening Organic Enforcement amendments narrowed exemptions and added supplier verification and fraud prevention to the organic system plan. This guide is for processors and handlers. It is orientation, not certification advice. Sources checked 4 Oct 2026.
Who must be certified
Section 205.100 requires each operation or portion of an operation that produces or handles products sold, labelled or represented as 100 percent organic, organic or made with organic ingredients to be certified, unless exempt under 205.101. Exemptions include operations with $5,000 or less in annual organic sales, some retail establishments, and handlers of sealed, tamper-evident packages that are not otherwise handled, each with conditions.
More on who must be certified
Exempt operations still follow the production, handling and labelling rules.
The Organic System Plan
Under 205.201 the plan, agreed with an accredited certifying agent, describes practices and their frequency, every input with its source, monitoring, the recordkeeping system and the barriers that prevent commingling and contact with prohibited substances. Since the 2023 amendments it also describes how the operation verifies suppliers and the organic status of products received and prevents organic fraud, scaled to the operation.
More on the Organic System Plan
Treat the plan as a controlled document and update it when processes change.
Commingling and Prohibited Substances
Section 205.272 requires handlers to prevent commingling of organic and nonorganic products and to protect organic products from contact with prohibited substances. It prohibits packaging, storage containers or bins containing synthetic fungicides, preservatives or fumigants, and reuse of bags or containers that could compromise organic integrity unless thoroughly cleaned.
More on commingling and Prohibited Substances
Split operations need clear status at receiving, in storage, on the line and at cleaning between runs.
Composition and Labelling Categories
Section 205.301 sets the categories by weight or fluid volume excluding water and salt: 100 percent organic contains only organic ingredients; organic contains at least 95 percent organic agricultural ingredients, with the rest from the National List or not commercially available in organic form; made with organic contains at least 70 percent. Keep the calculation with each formula version and recheck it whenever an ingredient or supplier changes.
Composition categories (205.301)
| Label term | Organic content |
|---|---|
| 100 percent organic | 100% |
| Organic | At least 95% |
| Made with organic (specified) | At least 70% |
- 100 percent organic
- Organic content
- 100%
- Organic
- Organic content
- At least 95%
- Made with organic (specified)
- Organic content
- At least 70%
Records that trace back
Section 205.103 asks certified operations to keep records adapted to the business that fully disclose activities and transactions, span purchase through production to sale or transport, are traceable back to the last certified operation, identify the organic category, and are kept at least 5 years. Records are available to the certifying agent and USDA during business hours.
Worked Example: Trace-Back for Lot OG-4410
More on records that trace back
Link each received lot's certificate and documents to production lots and shipments so a mass balance can be shown.
Questions
Do we need certification if we only store sealed organic packages?
Possibly not. Section 205.101(e) exempts operations that only receive, store or ship sealed, tamper-evident packages that stay sealed. Confirm with your certifier.
What percentage makes a product organic?
At least 95 percent organic agricultural ingredients, excluding water and salt, under 205.301(b).
How long are organic records kept?
At least 5 years beyond their creation, under 205.103.
Where does V5 fit?
V5 keeps supplier certificates, received lots, formulas, production and shipments linked, so your team can show trace-back and mass balance. Your certifying agent decides certification.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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