A Newcomer’s Guide to Organic Regulations for Handlers

As a new organic handler, opening the regulations can feel like being handed a legal textbook in a language you never studied. The good news is that you do not need to memorize the rules from front to back to do your job well. Rather, you need to understand how the regulations interface with your business and production practices to protect organic integrity.

When a shopper reaches for a product carrying the USDA organic seal, they are trusting a claim about how the food was grown and handled. That claim starts on a farm and travels through every operation that stores, processes, packages, or sells the product before it reaches the shelf.

The rules require you to keep organic products separate from nonorganic ones, to keep prohibited substances away from them, to document what you do, and to be honest about what your label claims. Each requirement is in place for a particular purpose, and once you see the purpose behind them, it stops feeling arbitrary and starts feeling like common sense with paperwork.

How the Regulations Are Organized

The rules that govern the USDA National Organic Program live in one place, Title 7, Part 205 of the Code of Federal Regulations.¹ You can read the most up-to-date text on the eCFR website. When you open and explore Part 205, you will see it is organized from the largest divisions down to the smallest, moving from part to subpart to section to paragraph.

Think of the subparts as chapters, each covering a major theme. There are seven of them.

• Subpart A defines the terms used throughout the rules. These are legal definitions, and they apply to your operation during certification and inspection, so reference them as you work to understand other regulations.
• Subpart B covers who has to be certified, recordkeeping, and which substances and methods are allowed or prohibited.
• Subpart C holds the practice requirements for production and handling, including the rules for importing organic products.
• Subpart D explains labeling, what organic claims can be made about products, and how the term “organic” and the USDA seal may be used.
• Subpart E lays out how you become and stay certified, including inspections and the process for granting or denying certification.
• Subpart F sets the requirements for certifying agents themselves and does not apply directly to your handling operation.
• Subpart G contains the National List of allowed and prohibited substances, product testing, enforcement, and appeals.

Reading a Regulatory Citation

Individual rules are referred to by their citation. Take § 205.103(b)(4). The number points you to Part 205, Section 103, paragraph b, item 4, moving from the general to the specific until you land on a single rule. Said aloud, that is “section two-oh-five, one-oh-three, bee four.” The symbol used in the regulations before the number, §, simply means “section.”

A Short Tour of the Regulations

With the roadmap in hand, here is a walk through the requirements that come up most often for handlers. This tour is a foundation, not the full text, and your operation may have circumstances covered by rules not summarized here. Use it to get your bearings, then go deeper where you need to.

Know Your Status

Before anything else, figure out whether you actually need to be certified.

A “handler” is any business that touches organic products after they leave the farm — processing, packaging, storing, or selling them.² This is a broad category. It includes obvious steps like milling and roasting, but also blending, freezing, labeling, receiving shipments, and trading.³

The basic rule: if you sell, label, or market a product as “100 percent organic,” “organic,” or “made with organic” ingredients, you need to be certified — unless one of a few specific exemptions applies.^4,5

You may be exempt from certification if you are a:⁵

• Very small operation, with gross organic sales of $5,000 or less per year.
• Retail establishment that sells organic products but doesn’t process them (for example, a grocery store simply stocking sealed organic goods).
• Operation that only handles already-sealed products in tamper-evident packaging that’s already labeled for retail sale.

Note that these exemptions are narrow and specific — if your operation does anything beyond what’s described above (even minor repackaging or relabeling), certification is likely still required. When in doubt, check with a certifying agent before assuming an exemption applies.

Brokers, traders, and importers are usually not exempt. If organic product passes through your hands as part of the supply chain, you generally need to be certified, so that the organic seal carries the same meaning at every step.

Every certified link in this chain exists to protect organic integrity. When each operation that touches an organic product is independently verified, there’s no unchecked point where nonorganic goods could be substituted in or mislabeled without detection. Certification isn’t a formality — it’s what allows the organic label to mean something consistent and verifiable from farm to shelf, and it’s a key tool for mitigating fraud within the supply chain.

Write Your Blueprint

Once you’ve determined that your operation is required to be certified, the next step is telling your certifier exactly how you plan to follow the organic regulations. You do this in your Organic System Plan, or OSP.

The OSP is the foundational document of your certification. Think of it as a detailed description of your operation’s day-to-day practices — everything you do to keep your products organic. This includes your ingredients and processing aids, product formulations, sanitation procedures, pest control practices, packaging, how you monitor your operation for compliance, and recordkeeping practices.⁷

Three things make an OSP work:

• It is documented in writing. Verbal practices or informal habits aren’t enough — everything needs to be documented.
• It is submitted to and approved by your certifier.⁷ You don’t just submit it and start operating; your certifier reviews it and signs off before it’s in effect.
• It stays current.⁸ Your OSP isn’t something you write once and file away — it’s a living document that has to reflect what you’re actually doing.

If you want to change a recipe, bring on a new supplier, or switch to a different sanitizer, you need to update your OSP and get your certifier’s approval before you make the change, not after⁸ — a common mistake for new handlers that can put certification at risk. This matters because your OSP is how your certifier verifies that your compliance controls actually address the risks the organic regulations are designed to prevent: a vague, generic plan raises questions at inspection, while a clear, specific one shows you’ve thought through exactly where organic integrity could be compromised — and exactly how your practices guard against it.

Protect Products in Your Custody

Almost everything you do with respect to the handling of organic product serves two goals, preventing commingling and preventing contamination.⁹

Commingling is the physical mixing of unpackaged organic and nonorganic products.¹⁰ If a few nonorganic apples fall into a bin of organic ones, the whole bin is compromised and may lose organic status. A single careless moment can cost real money and break the chain of custody. Operations that handle both organic and nonorganic goods, often called split operations, have to be especially careful, using physical separation, clear labeling, and staff training to keep the two apart.

Organic products can also be compromised when they come into contact with a prohibited substance. This is often referred to as “contamination.”⁹ A common example: some conventional sanitizers are designed to leave a lasting residue on surfaces for ongoing antimicrobial effect. But that residue is itself a prohibited substance, and it’s exactly what your cleaning protocols are designed to keep away from organic product. This is why sanitizer selection matters so much for organic handlers. On shared equipment such as a mixer or conveyor line also used for conventional product, you prevent contact by performing an adequate intervening event before organic product runs through. In practice, this often means a thorough rinse or wash step, and sometimes a test strip to confirm the surface is actually clean before organic production begins.

Pest control follows the same protective logic through a required, tiered approach.¹¹ You cannot simply spray pesticides in an organic facility, because doing so risks contaminating the products and packaging you are trying to protect. You start with prevention, removing food, water, and habitat and sealing pests out. If that is not enough, you move to mechanical and physical controls like traps and barriers. Only then may you turn to substances allowed on the National List, and a synthetic pesticide is a last resort that requires your certifier’s approval of the substance, how it is applied, and how you will keep it away from organic products.

Formulate and Label to the Standard

The rules also govern what goes into your product and what organic claims you can make on your product label. Organic product composition falls into categories set by the share of organic ingredients,¹² calculated by weight or fluid volume and excluding added water and salt.¹³

• “100 percent organic” products contain only organically produced ingredients.
• “Organic” products contain at least 95 percent organic ingredients, with any remaining ingredients allowed under the National List.^14,15
• “Made with organic” products contain at least 70 percent organic ingredients and may highlight up to three organic ingredients or food groups on the front of the package.

The product composition category decides what ingredients you may use in your formulation and the requirements that apply to your label. Certain composition categories permit the use of nonorganic agricultural products¹⁵ and certain nonagricultural substances,¹⁴ so long as they are included on the National List. For “organic” category products, you may use a listed nonorganic agricultural ingredient only when you can show your certifier that an organic version is not commercially available in the form, quality, or quantity you need.¹⁶ Retail labeling requirements include whether and how the label can display the USDA organic seal, use the word “organic”, where and how information about organic ingredients is displayed, and requirements to identify your certifier.^17,18 Livestock feed products can only be represented as “100 percent organic” and “organic”, and carry their own specific labeling requirements.^12,19

Why the precision? Because the label is the claim the shopper actually reads. The formulation and labeling rules make sure the word organic on the front of the package matches what is inside. Your certifier reviews and approves your product formulas and labels before you print or sell them, which is your chance to catch a problem before a customer does.

Prove It With Records

The USDA organic seal is backed by traceability, and that traceability lives in your records.²⁰ Certified operations must keep records of their organic activities for at least five years. Exempt operations must retain them for three years. As the old inspector’s saying goes, if it is not documented, as far as your inspection is concerned, it did not happen.

Your records face two main tests at your annual inspection.²¹ In a traceback audit, you show that a finished product can be traced back through your documentation to the incoming organic ingredients it came from. In a mass-balance audit, the inspector checks that the quantity of organic product you sold is supported by the quantity of organic ingredients you bought, so nonorganic material cannot be quietly substituted in.

The why here reaches beyond your own operation. Clean, complete records are how you stand behind your organic claim and protect the value of the seal for everyone in the market. They are also your first line of defense against organic fraud, a subject the fraud prevention articles in this handbook cover in depth.

Putting It All Together

The regulations hold a lot of detail, but for handlers the work comes together into four operational buckets. Formulate your product with allowed ingredients. Design a label and marketing materials that comply with the rules. Set up your operational activities for handling and processing to protect the integrity of your organic product. Write your blueprint in an OSP your certifier approves and prove it with records that trace and reconcile. And lean on the resources available to you as you navigate the organic certification process, namely this Guide and your certifier. While your certifier is not able to tell you exactly how to set up your organic systems, they are an invaluable aid in understanding what is allowed and required for organic compliance.

Now that you can find your way around the USDA organic regulations and you know the requirements that matter most to handlers, you are ready to begin the certification process itself.