Guide for Organic 

Processors

By Pamela Coleman

National Center for Appropriate 

Technology (NCAT)

Agriculture Specialist

November 2012

Contents

Chapter 1

Introduction...........................................1

Chapter 2

Considerations for 

Organic Processing............................4

Chapter 3

Getting Started in 

Organic Processing............................6

Chapter 4

Deciding Whether Organic 

Certification is Required.................9

Chapter 5

USDA Organic Regulations.........11

Chapter 6

Product Composition of 

Organic Processed Foods............13

Chapter 7

Labeling Organic Foods...............19

Chapter 8

The Certification Process.............24

Chapter 9

The Organic System Plan 

for Handlers......................................... 28 

Chapter 10

Nonagricultural Ingredients..... 33

Chapter 11

Agricultural Ingredients................37

Chapter 12

The Audit Trail.................................... 39

Chapter 13

Preparing for an 

Organic Inspection......................... 43

Chapter 14

Storage and Pest 

Management......................................46

Chapter 15

Resources............................................. 49

CHAPTER 1

INTRODUCTION

This publication is intended primarily as a guide for farmers who wish to add value 

to their organic crops through processing. It does not include the farm practices 

that are required to grow organic crops, raise organic livestock, or obtain organic 

certification for a farm. Information on those topics can be found in other ATTRA 

publications, which are listed in the Resources section.

Organic processing requires knowledge of the Federal, State, and local regulations that 

apply to processing and labeling foods. The specifics of food-processing regulations will 

not be cov ered here because the regulations can vary depending on the State and county 

jurisdictions. This guide will explain the regulations that are relevant to farmers who wish 

to process their organic crops and label or sell the product as organic. It will answer many 

questions relevant to all processors and handlers of organic commodities: 

•	 What are the benefits of organic processing?

•	 How do I get certified as an organic processor?

•	 What ingredients are allowed in organic foods? 

•	 How do I prepare for my organic inspection?

•	 Where can I find more information? 

Due to their complexity, the specific regulations for the sale of organic dairy products 

and the slaughter and sale of organic meat are not covered in this publication. If you raise 

organic livestock for meat, the animals must be slaughtered at a certified organic facility. If 

you process dairy products into butter, yogurt, cheese, or other products, you will need to 

be certified as an organic handler.

Who should read this publication? •	 Organic farmers who want to begin processing their crops

•	 Processors of conventional foods who would like to begin processing organic foods

•	 Distributors (handlers) of organic products

•	 Extension educators

It may help you to read this guide before you complete an application for organic certification. Note that this is not a required document; it is only a helpful tool. 

Value-added processing

Value often is added to fruits or vegetables by transforming them into processed food 

items. Farmers may choose to sell directly to customers through farmers markets, 

specialty stores, or a Web site, rather than selling to a distributor. 

Value-added foods include a diverse range of products:

•	 Jams, jellies, and preserves

•	 Pickles and preserved vegetables
Page 2 www.ams.usda.gov/nop Guide for Organic Processors

•	 Salsas

•	 Breads, cookies, and muffins

•	 Cheeses

Organic handled or processed products

The purpose of organic certification is to ensure the integrity of organic products in the 

marketplace. In the United States, there are two categories of organic certification: producers and handlers. Farmers who grow organic crops, raise livestock, or harvest wild crops 

are certified as producers. If farmers market their raw goods directly to consumers, restaurants, or retail stores, an organic producer certificate is sufficient. If products are processed 

on the farm, the farmers must obtain an organic handler certificate. Livestock producers 

typically do not market their meat or dairy products directly to consumers. Slaughtering 

animals and pasteurizing milk are considered handling activities and require an organic 

handler’s certificate. The sale of fresh eggs can be covered by the producer’s certificate.

An organic handling certificate also is required for processing or packaging agricultural 

products. Processing includes cooking, baking, curing, heating, canning, drying, mixing, 

grinding, churning, separating, extracting, slaughtering, cutting, fermenting, distilling, 

preserving, dehydrating, and freezing. Any of these value-added activities fit into the handling category of organic certification. Processing also includes the repackaging of foods 

from bulk bins into smaller containers labeled for retail sale. 

Handling includes many types of activities: 

•	 Roasting coffee

•	 Combining corn, soybeans, and alfalfa to make chicken feed

•	 Grinding whole corn into cornmeal

•	 Fermenting milk to make yogurt

•	 Fermenting grapes to make wine

•	 Pressing fresh apples to make cider

•	 Repackaging bulk coffee into retail bags

•	 Cutting a large wheel of cheese and repackaging the cheese into smaller packages

•	 Baking cookies in a deli and labeling them “organic”

•	 Any of the value-added foods listed above

How to use this publication

To be certified organic by a U.S. Department of Agriculture (USDA)-accredited certifying 

agent, operations must be managed in accordance with the Code of Federal Regulations 

in Title 7, Part 205: National Organic Program. Where the USDA organic seal appears, the 

text quotes from these Federal regulations. The verbatim text follows the reference number

detailing where the regulatory text can be found: for example, § 205.203. (The symbol 

§ refers to a numerical section of the USDA Organic Regulations.) The verbatim text is 

followed by an explanation of the regulation.

This icon indicates resources that are available on the Internet. 
Guide for Organic Processors www.ams.usda.gov/nop Page 3

This icon precedes the questions at the end of each chapter. The questions 

serve as a checklist to help you evaluate whether your products are eligible 

for organic certification and identify areas where your practices may need 

to be changed.

Consider each of the questions carefully and place a check in the appropriate box. Answers 

that accurately reflect your current circumstances will be the most helpful to you. If most 

of your checks are in the Yes boxes, your operation is more likely to be in compliance with 

the USDA Organic Regulations. Negative answers may indicate a need to modify your production practices or change the formulation of your product to qualify for organic status.

Notes 
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CHAPTER 2

CONSIDERATIONS FOR ORGANIC PROCESSING 

Many farmers have discovered that processing their farm produce has greatly benefited their bottom line. As you consider starting an on-farm processing venture, it’s helpful to get a clear picture both of the benefits you’ll receive and the 

challenges you may face. There are many things to consider when you add a new enterprise 

such as on-farm processing. As you read through the benefits and challenges below, think 

about which ones will have the greatest impact on your operation and weigh the options to 

determine what makes sense for you.

On-farm processing

Benefits

•	 Extra produce that cannot be marketed fresh can be preserved and sold at a later 

time. For example, peaches, berries, and cherries can be dried or frozen.

•	 Produce that is slightly blemished can be processed. For example, apples that are 

too small to sell can be made into cider or apple pie.

•	 Farm work can be spread throughout the year. For example, frozen berries can be 

processed into jam during the winter months.

•	 Seasonal farm workers can be employed during off-season periods.

•	 Additional family members may be employed in processing activities.

•	 If the processed product has a long shelf life, marketing can be spread throughout 

the year. This may affect your summer marketing, reducing the number of farmers 

markets that you need to attend.

•	 Value-added products sold off-season will provide income throughout the year.

•	 Value-added products typically command higher prices than raw agricultural 

products.

Challenges

•	 Creating a new product requires in-depth knowledge of Federal, State, and local 

food-safety regulations. Learning these regulations will take time.

•	 Creating a new product requires time to research labeling and trade-name requirements, develop formulations, source ingredients, and obtain applicable licenses.

•	 Creating a new product requires capital. Equipment, ingredients, and facilities may 

result in significant expenses before the product can be produced for sale.

•	 You will need new marketing strategies. Possible markets may include grocery 

stores, specialty stores, and Internet sales, in addition to winter farmers markets.

•	 A manager will need to oversee the processing operation, particularly during the 

busy summer months.

•	 Processing raises liability concerns. You may need insurance. 

Organic certification

Benefits

•	 Organic sales have shown steady growth in recent years.

•	 A product labeled organic may command a higher price in the marketplace.
Guide for Organic Processors www.ams.usda.gov/nop Page 5

Challenges

•	 Organic certification is required if the product is to be sold or labeled as organic.

•	 Organic handler certification involves time to complete paperwork.

•	 Organic handler certification fees will add an additional expense.

Conclusion

Although there are many potential benefits to be had from on-farm processing, getting 

started can be a challenge. It requires time, labor, and expense, as well as organizational 

skills to cover the many details involved. Despite the challenges, many farmers have been 

successful in bringing organic value-added products to market.

As a first step, you may want to consider marketing processed products without any 

organic claims. This allows you time to develop your product formulations, establish your 

processing facility, and familiarize yourself with processing regulations before delving into 

organic certification. You will need to consult with local and State authorities to make sure 

that you comply with all food-safety regulations.

 Questions

•	 Have you identified benefits you expect to receive from starting a processing venture?

•	 Have you considered the benefits of labeling your product “organic?”

•	 Have you developed an idea for a value-added product?

•	 Are you willing to accept the additional challenges of organic processing? 

If the answer to these questions is Yes, you are ready for the next chapter, “Getting started 

in organic processing.”

Notes 
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CHAPTER 3

GETTING STARTED IN ORGANIC PROCESSING 

Many people become interested in organic processing because they already own 

and manage an organic farm. If you have not yet obtained organic certification 

for your farm, ATTRA’s other guides can provide helpful information. Just as you 

need to have your farm established and your crops planted before applying for farm certification, you need to have your processing facility established and your processing methods 

developed before you apply for handler certification. This will ensure that the inspector will 

be able to view all aspects of the operation. The lists in this chapter can help you understand 

the steps involved. 

Plan for success 

One of the most important steps is the business-planning step. As you create a business 

plan, consider the unique aspects of your farm operation to find ideas for value-added 

products. Analyze your marketing opportunities and consider where you might market 

your product. You may want to investigate marketing through specialty food stores and the 

Internet as well as farmers markets and supermarkets. 

The business plan should include a precise formulation, or recipe, for each product and the 

quantity you plan to produce. A product formulation includes quantity of ingredients, processing aids, and processing methods (mixing, baking, etc.). Record your formulation with 

enough detail so that other people could follow the recipe.

A well-written business plan will include the extra time and expense that may be incurred 

to design or renovate a processing facility (certified kitchen) and purchase all the equipment needed for processing.

Throughout the planning process, learn as much as you can. Review the resources at the 

end of this guide, contact your local Extension office, attend conferences, and talk to other 

farmers. Funding may be available for market research, business planning, and product 

development.

Locate a processing facility

If you plan to do the processing yourself, rather than contracting with a co-packer, you will 

need access to a processing facility. As you begin processing in small batches, there may be 

a certified commercial kitchen facility in the community that is available for rent, or it may 

be necessary to build or renovate a kitchen on the farm. If you plan to build your own facility to process foods, think about these questions as you develop your design:

•	 Does the water supply meet safe-drinking-water standards?

•	 Is the building well sealed to prevent rodents from entering?

•	 Is the building designed to prevent insects from entering?

•	 Is the exterior of the building designed to be unattractive to rodents?

•	 Are the floors, walls, and ceilings washable?

•	 Are the work surfaces made of nonporous materials that can be cleaned easily?

•	 Are restrooms available?

•	 Are hand-washing facilities available?

•	 Are separate sinks available to wash equipment?

•	 Is lighting adequate?

Related ATTRA 

publications

www.attra.ncat.org

Guide for Organic 

Crop Producers

Guide for Organic 

Livestock Producers
Guide for Organic Processors www.ams.usda.gov/nop Page 7

•	 Are lightbulbs covered to prevent broken glass from falling into food?

•	 Is there adequate space to freeze or refrigerate items if needed?

•	 Is the equipment adequate for the processing that will be done?

•	 Is the kitchen well ventilated to avoid condensation on the ceiling?

Begin processing conventional food

This list highlights the most important steps that must be taken in order to establish a foodprocessing business. The questions at the end of this chapter cover these steps in more detail. 

1. Learn the Federal, State, and local regulations that apply to your type of processing.

2. Develop product formulations.

3. Find a reliable source of ingredients.

4. Find a source for packaging materials (jars, boxes, etc.).

5. Obtain access to a certified kitchen.

6. Obtain a county food-processing license, if needed.

7. Obtain a State food-processing license, if needed.

8. Learn Federal regulations for labeling foods.

9. Design a label. (Do not make organic claims until you are certified.)

10. Begin production. 

Obtain organic certification

After your processing business is established, obtaining organic certification will be 

straightforward with the help of this guide. 

1. Read this guide.

2. Apply for organic certification as a handler.

3. Prepare your organic labels for review and approval.

4. Receive your organic certificate from an accredited certifying agent.

5. Start full production and marketing of organic products. 

 Questions

•	 Have you created a business plan?

•	 Are you familiar with the Federal regulations that apply to your type of processing?

•	 Are you familiar with the requirements for an acceptable food-processing facility?

•	 Have you obtained access to a processing facility or commercial kitchen? 

•	 Are you familiar with the State regulations that apply to your type of processing?
Page 8 www.ams.usda.gov/nop Guide for Organic Processors

•	 Have you contacted your State department of agriculture to determine whether you 

need a State processor license?

•	 Are you familiar with the county regulations that apply to your type of processing?

•	 Have you contacted your county health department to determine whether you need a 

county processor license?

•	 Have you developed your product formulations?

•	 Have you written down the procedures to follow to process your food product?

•	 Have you applied for any needed food-processing licenses?

•	 Are you familiar with the labeling requirements for food products?

•	 Have you designed your label?

Notes 
Guide for Organic Processors www.ams.usda.gov/nop Page 9

CHAPTER 4 

DECIDING WHETHER ORGANIC CERTIFICATION 

IS REQUIRED

Reasons for handler certification

The purpose of the organic certification program is to maintain the integrity of organic 

food from farm to table. When the farmer sells raw fruits and vegetables directly to 

the consumer through farmers markets or community-supported agriculture (CSA), 

the farm’s certification is sufficient to ensure organic integrity. The farm’s Organic System 

Plan (OSP) covers all areas that contribute to or threaten organic integrity. When raw produce is transported, stored, handled, or processed, additional handler certifications may be 

needed to ensure organic integrity when the food is not on the farm. 

When farmers process their goods, they may require organic handling certification. 

On-farm processing may range from simple activities, such as freezing produce or drying 

herbs, to complex activities, such as making applesauce or baking bread. Your OSP must 

demonstrate compliance with all USDA Organic Regulations for all of your organic production and handling activities. Your certifying agent will review everything described in 

your OSP and everything seen during your on-site inspection. 

Certifying agents verify that handlers take the appropriate precautions to prevent contamination of the organic product by prohibited substances as well as to prevent the commingling of conventional and organic products. This concept will become clearer as you read the 

following descriptions of various types of enterprises.

If you require handler certification, you must obtain it before selling organic processed 

products. Even when certification is not required, any person who buys and sells organic 

products must keep accurate records and a complete audit trail to verify organic status. 

The following examples require handler certification:

•	 Bulk coffee is repackaged into retail bags.

•	 A large wheel of cheese is cut and repackaged into smaller packages.

•	 Cookies are baked in a deli and labeled “organic.”

•	 A farmer buys produce from other organic farmers and repacks it for sale to CSA 

members. 

•	 Organic produce grown on the farm is frozen or dried on the farm. 

•	 An organic farmer buys bulk organic produce and repacks it into smaller retail 

containers.

•	 A warehouse washes and waxes organic produce.

The following examples do not require handler certification:

•	 Farm-raised organic produce is stored on the farm for several months.

•	 Products prepackaged or prewrapped in retail containers are purchased for resale 

at a farm store.

•	 The front panel of the product does not make any organic claims.

•	 A distributor buys, stores, and sells organic produce without removing it from 

sealed bulk bins.

Final retailers typically are not required to be certified as organic handlers. They may 

purchase raw organic products in bulk for resale without certification so long as they do 

not repackage or relabel them.

Seeds

If a farmer raises a seed crop and sends it to a separate facility to be cleaned, the seedcleaning facility must have handler certification.
Page 10 www.ams.usda.gov/nop Guide for Organic Processors

Questions

The following questions about food processing will help you decide whether you need to be 

certified as an organic handler. 

	 •	 Do you cook, bake, heat, mix, or grind food?

	 •	 Do you cut, dehydrate, freeze, or dry food?

	 •	 Do you distill or extract?

	 •	 Do you preserve, can, or enclose food in a container?

	 •	 Do you churn, separate, or ferment food?

	 •	 Do you slaughter livestock?

	 •	 Do you chop or trim fruits or vegetables?

If the answer to any of the above questions is yes, proceed to the following question.

	 •	 Is the processed product sold, labeled, or represented as organic?

If the answer is yes, you are processing food and need to be certified as an organic handler.

The following additional questions about storing and repackaging food will help you decide 

whether you need to be certified.

	 •	 Do you mix livestock feed?

	 •	 Do you repackage bulk food into smaller containers?

	 •	 Do you unpack or repack fruits and vegetables?

If the answer to any of the above questions is yes, you need to be certified as an 

organic handler.

Notes 
Guide for Organic Processors www.ams.usda.gov/nop Page 11

CHAPTER 5 

USDA ORGANIC REGULATIONS

The National Organic Program (NOP) is part of the USDA Agriculture Marketing 

Service (AMS). The NOP develops, implements, and administers production, handling, and labeling regulations for organic agricultural products labeled or sold in 

the United States. The NOP also accredits the certifying agents, both foreign and domestic, who inspect organic production and handling operations and verify that they meet the 

USDA Organic Regulations. 

Most regulations are based on recommendations by the National Organic Standards Board 

(NOSB), a 15-member panel appointed by the U.S. Secretary of Agriculture. The NOSB 

includes organic producers (farmers), organic handlers (processors), retailers, environmentalists, scientists, and consumer advocates from across the United States. 

The USDA Organic Regulations outline the requirements that handlers and processors 

must meet in order to sell their products as organic. Organic certification is the process 

of verifying compliance with these organic regulations. This assessment process is carried 

out by a third-party certifier—an independent body that is not linked to either the buyer 

or the seller. Most products to be sold as organic in the United States must be certified by 

a USDA-accredited certifier, sometimes known as an accredited certifying agent. You can 

find a list of available certifying agents on the NOP Web site.

Producers who earn less than $5,000 from organic products annually are not required 

to apply for organic certification, although they still must comply with all production 

requirements. The products from such noncertified operations cannot be used as organic 

ingredients in processed products produced by another operation.

Products produced under the terms of a foreign equivalency agreement do not 

require certification by a certifying agent. Visit the NOP Web site to learn more about 

equivalency agreements.

Organic processing 

If you already operate an organic farm, you will be familiar with some of the regulations 

for organic certification. In order to obtain certification as a handler (processor), you will 

need to become familiar with the regulations that apply specifically to organic processing. 

Some of the applicable regulations are listed below:

•	 § 205.270 Organic handling requirements

•	 § 205.272 Commingling and contact with prohibited substance prevention 

practice standard

Related ATTRA 

publications

www.attra.ncat.org

Organic Standards 

for Handling: 

Excerpts of the USDA’s 

National Organic Program 

Regulations 

Organic certification

§ 205.100 What has to be certified

Under the USDA Organic Regulations, most operations that produce or handle 

agricultural products that are intended to be sold, labeled, or represented as 

organic must be certified. Producers who fraudulently represent their products as organic 

may be subject to prosecution and fines of up to $11,000 for each violation.

During the application process, many certifying agents will require farmers to sign an 

agreement that they will comply with the organic production and handling regulations in 

Title 7 Code of Federal Regulations (CFR) Part 205 National Organic Program Rule.
Page 12 www.ams.usda.gov/nop Guide for Organic Processors

•	 § 205.300 Use of the term “organic”

•	 § 205.301 Product composition

•	 § 205.302 Calculating the percentage of organically produced ingredients

•	 § 205.303 Packaged products labeled “100 percent organic” or “organic”

•	 § 205.304 Packaged products labeled “made with organic (specified ingredients or 

food groups(s))”

•	 § 205.305 Multi-ingredient packaged products with less than 70 percent organically produced ingredients

•	 § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on 

processed products labeled as ‘’organic’’ or ‘’made with organic (specified ingredients or food group(s))’’

•	 § 205.606 Nonorganically produced agricultural products allowed as ingredients 

in or on processed products labeled as ‘’organic’’

The remaining chapters of this guide will help you become familiar with the regulations 

listed above. 

Remember that organic certification is not a substitute for food-processing licenses and 

permits issued by your State and county. 

The NOP Web site

The NOP Web site provides a wealth of information about organic certification:

•	 Organic regulations – the entire text

•	 The Program Handbook – a guide for certifying agents and owners of 

certified operations

•	 List of certifying agents – help for finding a certifying agent

•	 The NOP Organic Insider – an electronic newsletter to keep you up to date

•	 Financial assistance – cost share to reimburse part of the cost of certification

•	 Training modules – detailed explanations of specific parts of the regulations

Online Resources

NOP Main Page, www.ams.usda.gov/nop

NOP Program Handbook, www.ams.usda.gov/NOPProgramHandbook

List of certifying agents, www.ams.usda.gov/NOPACAs

 Questions

•	 Do you have access to a copy of the requirements for organic processing? This may be in 

written form or as a link to the NOP Web site.
Guide for Organic Processors www.ams.usda.gov/nop Page 13

CHAPTER 6

PRODUCT COMPOSITION OF ORGANIC 

PROCESSED FOODS

There are five categories of organic processed food as defined by the labels allowed 

on the package:

•	 100 percent organic

•	 Organic

•	 Made with organic (ingredients)

•	 Claims only in the ingredient list

•	 Livestock feed

For each category, there are specific rules about the quantity of organic ingredients, 

whether nonorganic ingredients may be used, approved processing aids, and labeling. This 

chapter will explain the requirements for each category and how to calculate the percentage of organic ingredients in a product. Chapter 7 will explain the labeling requirements 

for organic products. 

Processed organic foods are composed primarily of organic agricultural ingredients. However, some types of processing may require nonorganic or nonagricultural ingredients. Sections § 205.605 and § 205.606 of the USDA Organic Regulations are part of the National 

List of Allowed and Prohibited Substances, which lists the substances that may be used 

in processed organic products. Section 205.605 defines which nonorganic substances are 

allowed in the handling and processing of organic foods. Section 205.606 lists the nonorganic agricultural substances that are allowed in the handling and processing of organic 

foods in cases where organic agricultural ingredients are not available. Chapters 10 and 

Chapter 11 explain these regulations in more detail. 

§ 205.301 Product composition

(a) Products sold, labeled, or represented as “100 percent organic”

(b) Products sold, labeled, or represented as “organic”

(c) Products sold, labeled, or represented as “made with organic (specified 

ingredients or food group(s))”

(d) Products with less than 70 percent organically produced ingredients

(e) Livestock feed

§ 205.2 Terms defined

Section 205.2 of the USDA Organic Regulations defines “processing aid” as follows:

(1) A substance that is added to a food during the processing of such food but is 

removed in some manner from the food before it is packaged in its finished form; 

(2) A substance that is added to a food during processing, is converted into constituents normally present in the food, and does not significantly increase the amount of the constituents 

naturally found in the food; and 

(3) A substance that is added to a food for its technical or functional effect in the processing but 

is present in the finished food at insignificant levels and does not have any technical or functional effect in that food.
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The “100 percent organic” labeling category is the most stringent. All ingredients other 

than water and salt must be certified organic. Salt may not be labeled organic because 

it is a naturally occurring mineral (sodium chloride), not an agricultural product. Salt 

used in organic products must be pure salt, free of any additives that are not organic. 

Water may not be labeled organic for the same reason: it is not an agricultural product. 

Any processing aids used in 100 percent organic products also must be certified organic. 

Products labeled “organic” must contain at least 95 percent organic ingredients, excluding 

water and salt. 

There are additional limitations on the type of nonorganic ingredients that may be used:

•	 Nonorganic agricultural ingredients must meet all of these criteria:

— Not commercially available in organic form

— Listed in § 205.606 (See Chapter 11, “Nonorganic Ingredients”)

— Not genetically engineered

— Not irradiated

— Not produced using sewage sludge

— Not produced using a volatile synthetic solvent

•	 Nonagricultural ingredients must be listed in § 205.605 (See Chapter 11, “Nonorganic ingredients”)

•	 Processing aids must be listed in § 205.605 

Certain nonorganic, nonagricultural processing aids are allowed in food labeled “organic” 

but not in food labeled “100 percent organic.” Decaffeinated coffee, for example, typically 

cannot be labeled “100 percent organic” because nonorganic processing aids are used in the 

decaffeination process. However, it may be labeled “organic.” 

100 Percent Organic

§ 205.301 (a) A raw or processed agricultural product sold labeled or 

represented as “100 percent organic” must contain ... 100 percent organically 

produced ingredients.

Organic 

§ 205.301 (b) A raw or processed agricultural product sold, labeled or represented as “organic” must contain ... not less than 95 percent organically produced raw or processed agricultural products. Any remaining product ingredients must be organically produced, unless not commercially available in organic form ... .

§ 205.2 Terms defined

Section 205.2 of the USDA Organic Regulations define “commercially available” as follows: 

“The ability to obtain a production input in an appropriate form, quality, or quantity to fulfill 

an essential function in a system of organic production or handling, as determined by the 

certifying agent in the course of reviewing the organic plan.”
Guide for Organic Processors www.ams.usda.gov/nop Page 15

Products labeled “made with organic (ingredients)” must contain at least 70 percent organic 

ingredients, excluding water and salt. There are additional limitations on the type of nonorganic ingredients that may be used:

•	 Agricultural ingredients must meet all of these criteria:

— Not genetically engineered

— Not irradiated

— Not produced using sewage sludge

•	 Nonagricultural ingredients must be listed in § 205.605 (See Chapter 10, “Nonagricultural ingredients”)

•	 Processing aids must be listed in § 205.605 

Organic ingredients in the information panel only

This labeling category applies to products that do not make any organic claims on the principal display panel of the product. The ingredients list may describe components as organic 

(e.g., “organic strawberries”). There are no restrictions on the nonorganic ingredients in 

these products.

Organic livestock feed must include only organic agricultural ingredients. It may include 

approved feed additives and supplements as listed in § 205.603 Synthetic substances 

allowed for use in organic livestock production.

A precise calculation of the percentage of organic ingredients is important because it will 

determine whether the product can be labeled “100 percent organic,” “organic,” or “made 

with organic ingredients.” In order to calculate the percentage of organic ingredients in 

your product, you will need to refer to its precise formulation. If you have obtained a foodprocessing license, you can use the product formulation you have developed. If you have 

not yet developed a formulation, doing so is well worth the time: you will need this information in order to obtain organic certification. The method for calculating the percentage 

of organic ingredients differs depending on whether the product is made with only liquids, 

only solids, or a mix of solid and liquid ingredients.

Ingredients that are either all solid or a mixture of liquids and solids

For a product that includes both solids and liquids, such as muffins made with flour and 

sugar (solids) and milk (liquid), you will need to change the quantities from a liquid unit of 

measurement (volume) to a weight. Using the weight of the liquid will enable you to express 

all ingredients uniformly.

Made with organic ingredients 

§ 205.301 (c) Multi-ingredient agricultural product sold, labeled, or represented as “made with organic (specified ingredients or food group(s))” must 

contain ... at least 70 percent organically produced ingredients... .

Livestock feed

§ 205.301 (e) (1) A raw or processed livestock feed product sold, labeled, 

or represented as “100 percent organic” must contain ... not less than 

100 percent organically produced raw or processed agricultural product.
Page 16 www.ams.usda.gov/nop Guide for Organic Processors

Using the table on page 17, follow these steps to calculate the percentage of organic ingredients in food products:

 1. Write the name of each ingredient, solid and liquid, in Column One.

 2. List the weight of each solid ingredient, except salt, in Column Two. 

 3. List the weight (not the volume) of each liquid ingredient, except water, in 

Column Two.

 4. Add the weights of all ingredients listed in Column Two. This is the total weight of 

all ingredients.

 5. In Column Three, note yes for each organic ingredient.

 6. In Column Four, list the weight of each organic ingredient. This will be the same 

as the weights listed in Column Two.

 7. Add the weights of all organic ingredients listed in Column Four. This is the weight 

of organic ingredients or the organic weight.

 8. Divide the organic weight by the total weight. This is the ratio of organic weight to 

total weight. 

 9. Multiply the ratio from Step 8 by 100 to obtain the percentage of organic ingredients.

10. Round the percentage down to the nearest whole number.

Calculations

§ 205.302 Calculating the percentage of organically produced 

ingredients

(a) The percentage of all organically produced ingredients in an agricultural product 

sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic 

(specified ingredients or food group(s))” or that include organic ingredients must be 

calculated by:

 1) Dividing the total net weight (excluding water and salt) of combined organic ingredients 

at formulation by the total weight (excluding water and salt) of the finished product.

 2) Dividing the fluid volume of all organic ingredients (excluding water and salt) by the fluid 

volume of the finished product (excluding water and salt) if the product and ingredients 

are liquid. If the liquid product is identified on the principal display panel or information panel as being reconstituted from concentrates, the calculation should be made 

on the basis of single-strength concentrations of the ingredients and finished product.

 3) For products containing organically produced ingredients in both solid and liquid 

form, dividing the combined weight of the solid ingredients and the weight of the 

liquid ingredients (excluding water and salt) by the total weight (excluding water and 

salt) of the finished product.

(b) The percentage of all organically produced ingredients in an agricultural product must 

be rounded down to the nearest whole number.
Guide for Organic Processors www.ams.usda.gov/nop Page 17

Calculating the percentage of solid and mixed liquid and solid 

organic ingredients

Fill in the table below with the weights of all ingredients. Be sure to use the same units 

of measurement for each ingredient. The metric system—grams and kilograms—may be 

easiest to calculate.

One Two Three Four

Ingredient name Weight of 

each ingredient

Organic? 

(yes/no)

Weight of 

organic ingredients

Sum= Sum=

Total weight Organic weight

Ingredients that are all liquids

Using the table on page 18, follow these steps to calculate organic ingredients in liquid food 

products:

1. Write the name of each ingredient in Column One.

2. List the volume of each ingredient, except water, in Column Two.

3. Add the volumes of all ingredients. This is the total volume of all ingredients.

4. In Column Three, note yes for each organic ingredient.

5. In Column Four, list the volume of each organic ingredient. This will be the same 

as the volumes listed in Column Two.

6. Add the volumes of all organic ingredients. This is the organic volume.

7. Divide the organic volume by the total volume. This is the ratio of organic volume 

to total volume.

8. Multiply the ratio from Step 7 by 100 to obtain the percentage of organic ingredients.

9. Round the percentage down to the nearest whole number.
Page 18 www.ams.usda.gov/nop Guide for Organic Processors

Calculating the percentage of liquid organic ingredients

Fill in the table below with the volume of all ingredients. Be sure to use the same units of 

measurement for each ingredient.

One Two Three Four

Ingredient name Volume of 

each ingredient

Organic? 

(yes/no)

Volume of 

organic ingredients

Sum= Sum=

Total Volume Organic Volume

 Questions

•	 Have you developed a product formulation that lists each ingredient and its quantity?

•	 Do you understand the requirements for the labeling category that you intend to use for 

your product?

•	 Have you calculated the percentage of organic ingredients in your product?

Notes 
Guide for Organic Processors www.ams.usda.gov/nop Page 19

Source: USDA National Organic Program

Label Anatomy

CHAPTER 7

LABELING ORGANIC FOODS 

After determining the labeling category for your organic product, it’s time to create 

a label that entices customers to buy and complies with the USDA Organic Regulations. This chapter will help you understand the regulations as they apply to organic 

product labels. Every label for every organic product must be approved by your certifying 

agent before it is attached to the product. Any time you add a new product to your organic 

line, that new label must be approved. The certifying agent’s expertise will ensure that the 

label meets the requirements.

The labels on a packaged product must meet certain criteria:

•	 Must display certain required items

•	 May display certain optional items

•	 Must not display certain prohibited claims 

These requirements are detailed in § 205.303 to § 205.307. This chapter explains the labeling requirements that pertain to foods making organic claims on the label. Note that other 

Federal labeling regulations will have additional requirements that pertain to all foods, 

both organic and conventional. This chapter will not explain those regulations because 

they are beyond the scope of the USDA Organic Regulations.

The sample label below shows the principal display panel on the left and the information 

panel on the right. 

§ 205.303 Packaged products labeled “100 percent organic” or “organic”

§ 205.304 Packaged products labeled “made with organic (specified 

ingredients or food group(s))”

§ 205.305 Multi-ingredient packaged products with less than 70 percent 

organically produced ingredients

§ 205.306 Labeling of livestock feed

§ 205.307 Labeling of nonretail containers used for only shipping or storage of raw 

or processed agricultural products labeled as “100 percent organic,” “organic,” or “made 

with organic (specified ingredients or food group(s))”
Page 20 www.ams.usda.gov/nop Guide for Organic Processors

100 percent organic

Labels that state “100 percent organic” also must display the statement “certified organic 

by” with the name of the certifying agent. For all processed products, the name of the 

certifying agent of the product’s final handler must appear on the product label. The statement “certified organic by” must be placed on the information panel below the name of 

the final handler of the product. If you send your products to be processed by a co-packer 

rather than processing them yourself, the certifying agent listed on the label must be the 

agent who certified the final processor of the product. (A contract packer, or co-packer, is a 

company that manufactures and packages foods or other products for their clients.)

Products labeled “100 percent organic” may display these optional items:

•	 The term “100 percent organic”

•	 Each organic ingredient identified as organic

•	 The USDA organic seal 

•	 The seal of the certifying agent 

If the words “100 percent organic” are used on the principal display panel, the font size of 

the text must be no more than one-half of the size of the largest letters on the panel.

If the USDA organic seal is used, it must be printed in one of two ways:

•	 Entirely in black and white

•	 In green and white with a brown outer circle.

The shades of green and brown are specified, and other colors are not allowed. Both 

versions of the seal may be downloaded from the National Organic Program (NOP) Web 

site. The seal or logo of the certification agent must not be displayed more prominently 

than the USDA seal.

§ 205.2 Terms defined

Principal display panel. That part of a label that is most likely to be displayed, 

presented, shown, or examined under customary conditions of display for sale.

Information panel. That part of the label of a packaged product that is immediately 

contiguous to and to the right of the principal display panel as observed by an individual 

facing the principal display panel, unless another section of the label is designated as the 

information panel because of package size or other package attributes (e.g., irregular shape 

with one usable surface).

The USDA organic seal
Guide for Organic Processors www.ams.usda.gov/nop Page 21

Organic 

Requirements for labeling foods “organic” are similar to those for labeling foods “100 

percent organic.”

Labels must display these items:

•	 Each organic ingredient identified as organic

•	 The statement “certified organic by” with the name of the certifying agent 

Labels may display seals of the USDA and the certifying agent as well as these optional items:

•	 The term “organic”

•	 The percentage of organic ingredients (on the front panel)

 Made with organic _____ 

Labels that state “made with organic _____ ” must display these required items:

•	 Each organic ingredient identified as organic

•	 The statement “certified organic by” with the name of the certifying agent 

Labels must not display the following:

•	 The USDA seal 

Labels may display the following:

•	 The statement “made with organic (specified ingredients)” or “made with organic 

(food groups)” 

•	 The percentage of organic ingredients in the product

•	 The seal of the certifying agent of the handler of the finished product

There are some restrictions on the term “made with organic.” Only three organic items 

may be listed. The items may be either individual ingredients or food groups. Ingredients 

include whole foods, such as tomatoes, corn, or cheese. The food groups that may be listed 

are beans, fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, 

vegetables, and processed milk products. If food groups are listed, all ingredients in that 

food group must be organic. The font size of the letters must be no more than one-half of 

the size of the largest type on the panel.

The above regulations are correct as of April 2012. However, the USDA is expected 

to issue further guidance regarding the labeling of organic products. Always check the 

NOP Web site or consult your certifying agent to obtain the most current regulations 

and guidance documents.

Organic ingredients in the information panel only

Products that make no organic claims on the principal display panel may list organic 

ingredients in the information panel. These products may be produced and sold without 

organic handler certification. There are no mandatory requirements for information that 

must be displayed. 

Labels must not display these prohibited items:

•	 The USDA organic seal

•	 The seal or logo of an organic certifying agent

Labels may display these optional items in the ingredient panel only:

•	 Each organic ingredient identified as organic 

•	 The percentage of organic ingredients in the product
Page 22 www.ams.usda.gov/nop Guide for Organic Processors

Livestock feed

Labels for livestock feed must display the following:

•	 The name of the certifying agent

Labels may display these optional items:

•	 The USDA oganic seal

•	 The seal of the certifying agent

•	 The term “100 percent organic” or “organic” as appropriate

•	 Each organic ingredient identified as organic 

Nonretail containers

Nonretail containers, such as apple bins, are the containers used to store or transport 

organic products. If a co-packer processes your product, the crop will be shipped from the 

farm to the co-packer in a nonretail container. The container must display a lot number 

that can be traced back to the farm in order to maintain identity of the organic product. 

The container may display the following: 

•	 Identification of the product as organic

•	 Name and contact information of the certifying agent

•	 Handling instructions to maintain organic integrity of the product

•	 The USDA seal

•	 The seal of the certifying agent

Shipping containers used to carry organic products for export may be labeled in accordance 

with requirements of the foreign country if they are clearly marked “For export only.”

Conclusion

This section described the most important items to consider when designing labels for your 

organic products. Certifying agents often are willing to review the labels as you design 

them. They will approve the final design when it meets all organic regulations. It’s best to 

obtain certifier approval before printing a large number of labels. If labels are printed before 

they are reviewed by the certifying agent, it is possible that they may not be approved, and 

you will not be allowed to use unapproved labels for your products.

 Questions

•	 Have you read the section of the USDA Organic Regulations that applies to the labeling category? — (“100 percent organic,” “organic,” or “made with organic (specified 

ingredients or food group(s))”?

•	 Does your label include the name of the final handler?

•	 If you display the USDA organic seal, have you verified that you are using the 

correct colors?

•	 If you must ship raw organic product to a co-packer, is each container labeled with a 

lot code that allows the product to be traced to its source?
Guide for Organic Processors www.ams.usda.gov/nop Page 23

100 percent organic

•	 If your product is “100 percent organic,” is each ingredient in the ingredient statement 

identified as organic?

•	 If your product is “100 percent organic,” does the label contain the statement “certified 

organic by” along with the certifying agent’s name?

Organic

•	 If your product is “organic,” is each organic ingredient in the ingredient statement 

identified as organic?

•	 If your product is “organic,” does the label contain the statement “certified organic by” 

along with the certifying agent’s name?

Made with organic ...

•	 If your product is “made with organic _____,” is each organic ingredient in the 

ingredient statement identified as organic?

•	 If your product is “made with organic _____,” does the label contain the statement 

“certified organic by” along with the certifying agent’s name?

No organic claims

•	 If your product does not make organic claims on the front label, have you avoided 

displaying the USDA Organic seal?

•	 If your product does not make organic claims on the front label, have you avoided 

displaying the seal or logo of any certifying agent?

Livestock feed

•	 If you are handling livestock feed, does the label contain the name of the 

certifying agent?

Notes 
Page 24 www.ams.usda.gov/nop Guide for Organic Processors

CHAPTER 8

THE CERTIFICATION PROCESS

Once you understand the USDA Organic regulations and your facility is set up to 

handle organic product, you’re ready to begin the certification process. Be sure to 

contact the certifying agent a few months before you plan to process organic foods 

and ask how long it will take to get certified. This will ensure that you have your organic 

certificate when you need it. If you need a certificate quickly, some certifying agents will 

expedite your application for an additional fee.

The process of getting certified involves coordination between the certifying agent, the 

organic operator, and the inspector. In applying for certification, the operator agrees 

to understand and comply with the regulations, be available for inspection, allow the 

certifying agent access to the processing facility and its records, and answer all of the

certifying agent’s questions. The certifying agent reads the application, assigns an 

inspector, reviews the inspection report, and makes the certification decision. 

Five steps to organic certification

Step 1. The operator submits an application to a certifying agent

You can apply for handler certification to any certifying agent who is accredited by the 

USDA National Organic Program (NOP). A list of all accredited certification agents (ACAs) 

can be found on the NOP Web site listed at the end of this chapter. 

An application for organic handler certification typically consists of the following 

documents:

•	 Application form

•	 Organic System Plan for Handlers

•	 Product profiles

•	 Operator agreement or affirmation

•	 Report of organic sales

The Organic System Plan (OSP) for Handlers may be called the Organic Handling System 

Plan, the Handling Organic System Plan, or the Organic Handling Plan, depending on the 

terminology used by your certifying agent. Just as the OSP for Producers describes your 

farm operation, the OSP for Handlers describes your processing operation. The product 

profile lists all ingredients used in each product. Chapter 9 will provide more detail about 

how to prepare your OSP and product profiles. 

The person who signs the operator agreement agrees to adhere to the regulations and 

affirms that the information supplied to the certifying agent is correct. This agreement 

should be signed by the person who has responsibility for making decisions about the 

operation—typically the owner or a high-level manager.

Many certifying agents will request that applicants report their annual sales of organic 

product. New applicants will be asked to estimate their projected organic sales. Ordinarily, the sales are reported in the calendar year during which the sales revenue is realized. 

Certifying agents will request that you pay their fees before they begin reviewing your application materials. Be sure to inquire about the fee structure because it varies among certifiers. 

Step 2. The certifying agent reviews the application materials

The certifying agent will read the Handling OSP and determine whether the practices are 

described in sufficient detail to fully describe your operation. If a product will be labeled 
Guide for Organic Processors www.ams.usda.gov/nop Page 25

“organic” or “100 percent organic,” the certifying agent will review all ingredients and processing aids to verify that they meet the requirements of § 205.301, Product Composition. 

If the OSP is complete, and if the practices appear to comply with organic standards, the 

certifying agent will assign an inspector to visit your facility.

Step 3. The inspector visits the processing facility 

Every processing facility must be inspected annually. The organic inspector represents the 

certifying agent and must:

•	 Verify that the OSP accurately describes the operation

•	 Verify that the owner and employees are following the OSP

•	 Look for any violations of the USDA Organic Regulations

During the inspection, you must allow the inspector complete access to your operation, 

including all production facilities and storage areas. The inspector will ask questions about 

your operation and review the following documents:

•	 Application documents sent to the certifying agent

•	 Records of production processes

•	 Invoices for purchased ingredients

•	 Organic certificates from ingredient suppliers

•	 Records of sales of organic products

•	 Current product formulations

Organic inspectors maintain strict confidentiality. Information you provide about product 

formulations, sources of ingredients, sales, or any other practices will not be shared with 

anyone except the certifying agent or the USDA. Confidential business information is protected under a Freedom of Information Act exemption, so neither your certifying agent nor 

the USDA will intentionally compromise this information. 

The inspector can explain the organic regulations but is not allowed to provide advice on how 

to overcome barriers to certification. This separation between the farmer and the certifying 

agent maintains the “independent third party” nature of the transaction. Similarly, inspectors 

are not allowed to accept gifts because it may compromise their independent status.

At the conclusion of the inspection, there will be an exit interview during which the inspector will review any areas of concern. After the inspection, the inspector will write a report 

and send it to the certification agency. 

Step 4. The certifying agent reviews the inspection report

The certifying agent reviews the inspection report, along with the initial application, and 

decides whether your operation meets the USDA Organic Regulations. The reviewer will 

pay particular attention to any issues mentioned in the exit interview and will decide the 

seriousness of those issues. If your handling operation complies with the regulations, you’ll 

receive an organic certificate. Often, your first inspection will identify some issues that 

need to be addressed. In this case, certification will be delayed until these problems are 

corrected. Your inspector will make you aware of these issues during your exit interview. 

Your certifying agent will send you a letter detailing these issues, which is titled a Notice 

of Noncompliance. The formal title is a requirement of the USDA Organic Regulations. 

Your particular issues may be easily corrected, and once you resolve them, you can receive 

organic certification. More serious issues may require additional modifications to bring 

your operation into compliance with the USDA Organic Regulations. 

New applicants may receive several types of letters from their certifying agents:
Page 26 www.ams.usda.gov/nop Guide for Organic Processors

•	 If the operation is in compliance with the regulations, the certifying agent issues 

an organic certificate.

•	 If the operation needs to provide additional information or correct minor 

practices, the certifying agent issues a certificate with conditions. There will be 

a deadline by which the applicant must respond to these conditions, which is 

usually no more than 30 days. 

•	 If there is something that threatens the organic integrity of the product that can be 

corrected, the certifying agent issues a Notice of Noncompliance. 

•	 If there are major noncompliance issues that cannot be corrected, the certifying 

agent issues a Notice of Denial of Certification to new applicants, along with the

Notice of Noncompliance. 

•	 If there are major noncompliance issues during the certification-renewal process, 

the certifying agent issues a Notice of Noncompliance. This notice may be either followed by or sent at the same time as a Notice of Proposed Suspension or Notice of 

Proposed Revocation. The producer or handler is provided an opportunity to appeal 

or request mediation; otherwise, the organic certification is suspended or revoked 

through a Notice of Suspension or Revocation. 

If you receive a letter and do not understand any technical language it may 

contain, call your certifying agent for clarification. You also can call ATTRA for advice 

on how to resolve an issue and bring your operation into compliance. The ATTRA 

hotline is 800-346-9140. The Spanish-language ATTRA hotline is 800-411-3222.

Step 5. The certifying agent issues the organic certificate

Congratulations! You’re certified!

Annual renewal of certification

Every organic operation is required to renew its certification each year. Certification may 

be suspended if it is not renewed. You also may voluntarily surrender your certificate if you 

do not want to remain certified. 

The renewal process comprises the following steps: 

•	 Update the OSP

•	 Address all noncompliance issues that have not been resolved 

•	 Pay the annual certification fees

•	 Have an annual inspection 

Many certifying agents also will require you to sign an operator agreement or affirmation 

stating that the information you supplied is correct. 

Once certification is granted, it remains in effect until it is surrendered voluntarily, 

suspended, or revoked. 

Online Resources

ATTRA, www.attra.ncat.org

National Organic Program, www.ams.usda.gov/nop

New Farm Guide to U.S. Organic Certifiers, www.rodaleinstitute.org/

certifier_directory
Guide for Organic Processors www.ams.usda.gov/nop Page 27

Certification fees

Certification fees may vary significantly among certifying agents. You may 

request a written fee estimate from a certifying agent at any time. Most certifying agents charge a one-time fee to new applicants to cover administrative and 

review costs. Annual renewal fees, which sometimes are based on the sales of organic 

products, are assessed each year. Some certifying agents include the inspection costs up front; 

others will charge additional fees after the inspection to cover its cost.

The NOP administers a cost-share program for certified organic operators. The program reimburses farmers and handlers for a percentage of their certification fees. As of this writing, 

each individual certificate (Producer – Crops, Producer – Wild Crops, Producer – Livestock, 

and Handler) is eligible for reimbursement of up to 75 percent of the certification fees. The 

application process is simple. Information on how to apply is available from your certifying 

agent, your State department of agriculture, the NOP, or ATTRA.

 Questions

•	 Do you have a processing facility that is fully equipped to process your organic product?

•	 Have you decided which certifying agent to apply to? Have you contacted the certifying 

agent to determine how long the certification process will take?

•	 Have you obtained all the forms that are part of the application?

Notes 
Page 28 www.ams.usda.gov/nop Guide for Organic Processors

CHAPTER 9

THE ORGANIC SYSTEM PLAN FOR HANDLERS

Under the USDA Organic Regulations, each certified operation must have an Organic 

System Plan (OSP) as part of the application materials sent to the certifying agent. 

The OSP must be written by a representative of the organic producer or handler 

and approved by the certifying agent. If you have a farm and are certified as a producer, 

your OSP will cover only the planting, growing, harvesting, and possibly the storage of your 

crops. If you want to handle or process crops, you’ll need to complete a separate OSP for 

Handlers that describes your processing activities, such as the following:

•	 Type of handling

•	 Ingredient purchases

•	 Transportation of raw ingredients

•	 Storage

•	 Cleaning and sanitation

•	 Processing

•	 Pest management

•	 Sales

•	 Recordkeeping

All activities must be explained in sufficient detail to allow the certifying agent to get a 

clear picture of your operation and assess whether you can meet the requirements for 

organic certification. 

This chapter explains the type of information that may be requested by your certifying 

agent. It is only a guide to typical questions. Since handling operations are diverse, not all 

questions apply to all operations. The certifying agent may request additional information 

to better evaluate whether your operation complies with the regulations. 

Flowchart 

A flowchart shows the movement of organic products from the time they are received at 

the facility to the time they are sold as finished products. Many flowcharts are diagrams, 

but they can be simply a list of steps to be followed in processing. Flowcharts must indicate each processing step and each step where ingredients or processing aids are added. A 

§ 205.201 Organic production and handling system plan

(a) The producer or handler of a production or handling operation ... must 

develop an organic production or handling system plan that is agreed to 

by the producer or handler and an accredited certifying agent ... An organic 

production or handling system plan must include:

(1) A description of practices and procedures to be performed ...;

(2) A list of each substance to be used as a production or handling input ...;

(3) A description of the monitoring practices and procedures to be performed ...;

(4) A description of the recordkeeping system ...;

(5) A description of the management practices and physical barriers established ...; and

(6) Additional information deemed necessary by the certifying agent to evaluate 

compliance with the regulations.
Guide for Organic Processors www.ams.usda.gov/nop Page 29

separate flowchart must be submitted for each type of product. For example, if you are drying herbs and use the same equipment to dry mint, basil, and lavender flowers, you would 

probably need only one flowchart. If you are producing tomato salsa and strawberry jam, 

on the other hand, you would need to prepare a separate flowchart for each because they 

are different types of products.

Facility map

The map or diagram of the processing facility should be sufficiently detailed so that the 

inspector can see where the processing equipment is located. If your operation includes 

boilers, freezers, slicers, ovens, or other equipment, they should be included on the facility 

map. Any areas where organic ingredients or finished products are stored should be indicated on the facility map as well.

Individual product profiles

A product profile must be submitted for each individual product that you process. The 

product profile lists all ingredients and processing aids and the suppliers from which you 

obtained them. If you have developed a product formulation, as mentioned in Chapter 

3, you will already have most of the information at your fingertips. The quantity of each 

ingredient must be listed to allow your certifying agent to verify that the percentage of 

organically produced ingredients is consistent with the statement on your product label. 

In other words, if you intend to label your product “organic,” the certifying agent will 

calculate the percentage of organic ingredients to verify that it is 95 percent or higher.

If water or salt are used, they must be listed on the product profile. They are not counted 

when calculating the percentage of organic ingredients. Water used as an ingredient must 

meet the standards set by the Safe Drinking Water Act (SDWA). 

A sample product profile is included at the end of this chapter to get you started. Check to 

see if your certifying agent has preferred product profile forms. It’s always advisable to use 

your certifying agent’s forms. 

Supplier certificates 

If you purchase organic ingredients, you will need to obtain current organic certificates 

from each supplier to verify that the ingredient is indeed organic. When you purchase the 

ingredient, keep the invoice and verify that the item is marked “organic” on the invoice. 

If you purchase an item, such as organic sugar, from the grocery store, save the label and 

the receipt.

Since operations are provided new organic certificates each year when they successfully 

complete a renewal, you should plan to obtain the most current certificates on a regular 

basis and keep them on file so they can be viewed by the inspector. The current certificates 

verify that the suppliers have maintained their organic certification.

Sample labels

You will need to send a label from each organic product to your certifying agent for review. 

It’s best to create a full color mockup of the label and send it to the certifying agent for 

approval before ordering printed labels. If the USDA organic seal will be on your label, the 

certifying agent will want to verify that it is printed only in the allowed green and brown 

colors, or in black and white.

Sanitation 

Because they present a possible risk of contamination to organic foods, any materials used 

on food-contact surfaces must be listed in your OSP. Cleansers are used to remove dirt, 
Page 30 www.ams.usda.gov/nop Guide for Organic Processors

oils, or other materials from both storage containers and processing equipment. Nearly 

all cleansers are allowed because they typically are rinsed off without leaving any residue. 

Sanitizers fall into a different category. They are distinguished from cleansers because they 

are used on clean surfaces to kill microorganisms that may contaminate food and often 

aren’t rinsed. Chapter 10, “Nonagricultural ingredients,” explains what types of sanitizers 

are allowed and how to determine whether the specific product you want to use is allowed 

for organic processing.

Washing produce

Produce may be washed in water after it is harvested if the water meets the standards set by 

the SDWA. Your certifying agent may require an annual water test to verify that no harmful microorganisms are present in the water supply.

If you add any substances to the wash water, such as anti-foaming agents, anti-microbial 

agents, or microbes for disease prevention, they must be listed on the OSP. Waxes or other 

substances applied to produce after it is washed must be listed in the OSP as well. 

Recordkeeping system

A complete recordkeeping system includes all the documents required to track the flow 

of organic product through your system. Records begin with purchase or harvest of raw 

ingredients on your farm, continue through storage and processing, and end with sale 

of the final product. Records for organic production must be clearly differentiated from 

records for conventional production.

Processors must keep invoices, purchase orders, storage records, processing records, and 

similar items. Chapter 12, “The Audit Trail,” has more details on the types of documents 

that will be needed.

Split operations

If you store, handle, or process any conventional products in addition to your organic products, you have a split operation. Your OSP and your certification includes only the management of organic products. However, the certifying agent probably will ask whether you 

handle conventional products. You will need to explain how you will prevent the conventional items from being commingled (mixed together) with the organic items. 

If the same ingredients are used both for organic and conventional products, you will need 

to present a plan for keeping the items separate. For instance, a bakery that purchases 

organic flour to bake organic bread and conventional flour to make conventional cupcakes 

would need to demonstrate a plan for identifying and separating the two types of flour. 

Although the final products differ, the use of an ingredient in both organic and conventional form increases the risk of commingling. On the other hand, if there are few similarities between your conventional and organic products, such as organic dried apples 

and conventional tomato salsa, there may be little danger of commingling. Your certifying 

agent still will need your plan for keeping the materials and products separate.

Parallel operations

An operation that processes the same product in both organic and conventional form often 

is called a parallel operation. Processors that produce both conventional and organic frozen 

vegetables, roasted coffee, or canned tomato sauce would be parallel operations. In parallel 

production, the OSP must include a plan to prevent commingling of organic and conventional ingredients and final products. Good recordkeeping is essential for maintaining an 

audit trail for parallel products, which may be visually identical. 
Guide for Organic Processors www.ams.usda.gov/nop Page 31

Annual renewal of certification

A new application, along with an updated OSP, must be submitted to the certifying agent 

each year. The OSP must be updated whenever a new product is added or the operation 

moves to a new facility. Typically, a new product can be added to your organic certificate at 

any time if you contact the certifying agent and send the relevant paperwork. Even if you 

plan to change only a product formulation or a label, you should notify the certifying agent 

of your plans in order to ensure that your OSP is current.

Notes 

 Questions

•	 Have you obtained a copy of the Organic System Plan for Handlers forms from 

your certifying agent?

•	 Have you obtained a copy of the Product Profile Forms from your certifying agent?

•	 Have you prepared a flowchart for each product?

•	 Have you drawn a map or diagram of your facility?

•	 If you use water to wash produce or as an ingredient, have you verified that your water 

meets the Safe Drinking Water Act?

•	 Have you obtained an organic certificate from each supplier of an organic ingredient?

•	 Have you reviewed your recordkeeping system to verify that organic handling and 

processing activities are clearly distinguishable from nonorganic activities? 
Page 32 www.ams.usda.gov/nop Guide for Organic Processors

Organic Individual Product Profile Form

Business name

Product Name

Product category (circle one):

“100 percent organic”

“Organic”

“Made with organic (...)”

Formulation

Ingredient Supplier Certification agent of supplier Organic? 

Yes / No Weight Percent of 

finished product

Weight of organic ingredients

Total weight of all ingredients

Percent of organic ingredients

Processing aids

Processing aid Supplier Application and use
Guide for Organic Processors www.ams.usda.gov/nop Page 33

CHAPTER 10

NONAGRICULTURAL INGREDIENTS

The National List

S

ections 205.601 through 205.606 of the Code of Federal Regulations constitute the 

National List of Allowed and Prohibited Substances for crop production, livestock 

production, and handling: 

•	 § 205.601 Synthetic substances allowed for use in organic crop production

•	 § 205.602 Nonsynthetic substances prohibited for use in organic crop production

•	 § 205.603 Synthetic substances allowed for use in organic livestock production

•	 § 205.604 Nonsynthetic substances prohibited for use in organic livestock production

•	 § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or 

on processed products labeled as "organic" or "made with organic (specified 

ingredients or food group(s))"

•	 § 205.606 Nonorganically produced agricultural products allowed as ingredients 

in or on processed products labeled as "organic"

The National List was created to define explicitly which nonorganic substances would 

be allowed for use in organic crop production, livestock production, or production of 

processed foods. Two sections of the National List contain substances prohibited for 

organic crop and livestock production; two sections contain substances specifically allowed 

for organic crop and livestock production; and two sections contain substances allowed for 

processing and handling.

Processed organic foods are composed primarily of agricultural ingredients. Some types of 

processing require nonagricultural products, such as sodium bicarbonate (baking soda) for 

a leavening agent or diatomaceous earth for filtering. Since these substances are essential 

for certain types of processing, the last two sections of the National List address the cases 

where it is necessary to use a substance that is either nonorganic or nonagricultural (and 

by definition nonorganic). Section 205.605, discussed in this chapter, lists the nonagricultural substances that are allowed in the handling and processing of organic foods. Section 

205.606, discussed in the next chapter, lists the nonorganic agricultural substances that are 

allowed in the handling and processing of organic foods. 

Determining whether a nonagricultural substance 

is allowed

You may need to use some nonagricultural substances in your food processing, such

 as sanitizers, filtering aids, or leavening agents. Your certifying agent must approve all 

§ 205.605 Nonagricultural (nonorganic) substances allowed as 

ingredients in or on processed products labeled as “organic” or 

“made with organic (specified ingredients or food group(s)).”

The following nonagricultural substances may be used as ingredients in or 

on processed products labeled as “organic” or “made with organic (specified 

ingredients or food group(s))” only in accordance with any restrictions specified in this section.

(a) Nonsynthetics allowed

(b) Synthetics allowed
Page 34 www.ams.usda.gov/nop Guide for Organic Processors

nonagricultural substances before they can be used in your products. One way to determine 

whether a substance is allowed in organic production is to verify that it is on the National 

List. If a substance is not organic, it may not be used as an ingredient or processing aid in 

products labeled “organic” unless it is in § 205.605 or § 205.606 of the National List. 

The National List only lists generic substances. There are two organizations that currently 

publish brand names of products allowed for organic production and handling: the 

Washington State Department of Agriculture (WSDA) and the Organic Materials Review 

Institute (OMRI). 

Neither WSDA nor OMRI evaluates the product’s effectiveness, nor are their listings an 

endorsement of the product. Companies are not required to register their products with 

WSDA or OMRI. 

The National List, as well as the WSDA and OMRI lists, are updated on a regular basis. 

Materials may be added or removed, and new products are evaluated. In addition, anyone 

may submit a petition to the National Organic Standards Board (NOSB) requesting that a 

generic substance be added to the National List at any time. The NOSB meets twice annually to review petitions and make formal recommendations to USDA. These recommendations inform rulemaking actions, which may result in occasional changes to the National 

List. The USDA may not add a substance to the National List without the NOSB’s recommendation.

The NOSB also conducts reviews of each substance on the National List every 5 years. During the review, the NOSB will recommend whether the substance should continue to be 

allowed or prohibited. This process is commonly referred to as “sunset” review and may 

result in changes in the allowance of substances already on the National List. In short, 

it’s important to stay informed about changes to the National List. Your certifying agent 

always should be able to provide you with the latest information. 

Microorganisms

Many types of food processing require the addition of microorganisms. Specific strains of 

bacteria, yeasts, and other fungi may be added to agricultural products to make beer, wine, 

yogurt, bread, vinegar, cheese, sauerkraut, soy sauce, and other fermented foods. Other 

types of microorganisms are applied to freshly harvested produce to reduce the incidence 

of post-harvest decay. This is most common with crops that will be stored, such as potatoes, 

apples, pears, and citrus fruit.

Microorganisms are considered nonagricultural, nonsynthetic (or natural) substances. 

They are listed in § 205.605 (a) “Nonsynthetics allowed,” which means they are allowed 

for use in organic products if they are food-grade bacteria, fungi, or other microorganisms. Yeasts are listed separately from other microorganisms. They must be nonsynthetic 

and must not be grown on petrochemical substrates. All yeasts and other microorganisms 

must not be genetically modified (GMO). Before you purchase a specific strain for use in 

organic production, obtain written verification from the manufacturer that the strain is 

non-GMO and include the verification in your Organic System Plan (OSP). Be aware that 

new GMO strains of microorganisms are continually being developed because the science 

of molecular biology is a rapidly changing field. You will need to verify the non-GMO 

status on a regular basis, at least annually, and possibly each time you purchase the 

microorganism product.

Cleansers and sanitizers

Nearly every handler uses some type of cleanser and some type of sanitizer. Although 

commonly grouped together, these are different products used for different purposes. 
Guide for Organic Processors www.ams.usda.gov/nop Page 35

Cleansers

A cleanser is used to remove soil, food particles, or unwanted debris from surfaces. Soaps 

and detergents are cleansers. Typically, cleansers are fully rinsed from food-contact surfaces; therefore, they never make contact with the food. Phosphoric acid is the only cleanser 

on the National List. Most other cleansers are allowed for use in organic production and 

handling; they do not need to be on the National List. 

Sanitizers

Sanitizers differ from cleansers in that their purpose is to kill microorganisms, not to 

remove soil or other debris. Sanitizers are applied after food-contact surfaces are cleaned. 

Sanitizers also may be applied to fresh produce to kill harmful surface microorganisms or 

added to wash water for fruits, vegetables, eggs, poultry, and meat products. 

Section 205.605 of the National List explicitly mentions these allowed sanitizers: 

•	 Acidified sodium chlorite

•	 Chlorine materials (including bleach)

•	 Hydrogen peroxide

•	 Ozone

•	 Peracetic acid/Peroxyacetic acid

Specific brand names of approved sanitizers can be found on the OMRI or WSDA lists, 

although other products also may comply with the USDA Organic Regulations. The lists 

also mention any particular restrictions or other allowed uses. Some sanitizers leave 

residues on the equipment. In such cases, depending on the sanitizer you are using, 

the certifying agent may require you to have a plan to remove residues as well as a way to 

document that residues have been removed.

Chlorine 

Chlorine is one of the most commonly used sanitizers, both for food-contact surfaces 

and on agricultural products. As listed in § 205.605 (b) “Synthetics allowed,” chlorine 

materials are allowed for “disinfecting and sanitizing food contact surfaces” in organic 

processing. The regulation also states that “residual chlorine levels in the water shall not 

exceed the maximum residual disinfectant limit under the Safe Drinking Water Act,” 

which is currently 4 parts per million (ppm) chlorine. The NOP 5026 guidance document, “The Use of Chlorine Materials in Organic Production and Handling,” clarifies 

the allowed use of chlorine. The online address for the document is listed in this chapter 

under “Online resources.” 

When washing produce, the rinse water that makes final contact with the organic 

product must not contain more than 4 ppm chlorine. In other words, a food product, 

such as apples, may be bathed in water containing a higher concentration of chlorine if 

doing so is permitted by the U.S. Environmental Protection Agency, but that product 

must receive a final rinse of water containing no more than 4 ppm chlorine. The procedures used to wash produce and to monitor chlorine levels in the wash water must 

be included in the OSP. 

You must include all cleansers and sanitizers on your OSP, and they must be approved 

by your certifying agent before you use them. Review § 205.605 to get familiar with the 

diversity of materials listed. The latest version of the list can be accessed from the NOP Web 

site under the tab Organic Regulations. The online address is listed in this chapter under 

“Online resources.”
Page 36 www.ams.usda.gov/nop Guide for Organic Processors

Online Resources

NOP 5026: The Use of Chlorine Materials in Organic Production and 

Handling, www.ams.usda.gov/nopprogramhandbook

OMRI Materials Lists, www.omri.org

USDA National Organic Program, www.ams.usda.gov/nop

WSDA Materials Lists, www.agr.wa.gov/FoodAnimal/Organic/MaterialsLists.aspx

 Questions

•	 Have you reviewed the sections of the National List that apply to processors and handlers?

•	 Have you listed all the cleansers and sanitizers that you plan to use in your Organic 

System Plan?

•	 Have you verified that any nonagricultural ingredients or processing aids you intend to 

use are allowed for organic handling?

•	 If you will wash produce, have you verified that any materials added to the wash water 

are allowed for organic handling?

Notes 
Guide for Organic Processors www.ams.usda.gov/nop Page 37

CHAPTER 11

AGRICULTURAL INGREDIENTS

Chapter 10 discussed one section of the National List of Allowed and Prohibited 

Substances: nonorganic nonagricultural substances that are allowed as ingredients 

in organic products. This chapter discusses the next section of the National List: 

nonorganic agricultural ingredients that are allowed for use in organic products. 

As a general rule, all agricultural ingredients in products labeled as “organic” must be 

organic. Section 205.606 of the National List contains the few exceptions to this rule: the 

nonorganic agricultural products that are allowed for use in products labeled as “organic.” 

These nonorganic ingredients are permitted only if the organic form is not commercially 

available. These nonorganic products may constitute a maximum of 5 percent of the final 

organic product. Items on the National List are primarily ingredients that would be used 

in small amounts, such as colors derived from plant sources, herbs, and spices.

Commercial availability

Nonorganic ingredients listed in § 205.606 may be used in “organic” products only if an 

organic ingredient is not commercially available. Agricultural ingredients in products 

labeled “made with (specified ingredients or food group(s)” are not subject to this requirement. “Commercially available” is defined under the USDA Organic Regulations as “the 

ability to obtain a production input in an appropriate form, quality, or quantity to fulfill an 

essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan (§ 205.2).” In order to demonstrate 

that a product is not commercially available, you need to search for organic ingredients 

and document that search, listing the companies you contacted and the date. Ingredients 

are increasingly available as organic, but it may take some time to find suppliers that offer 

the form, quality, and quantity you need. According to the USDA Organic Regulations, 

difference in price is not permitted as a reason to use a nonorganic ingredient instead of 

the organic one.

Sourcing organic ingredients

There are several approaches to sourcing organic ingredients. 

The National Organic Program (NOP) Web site has a searchable database that includes 

all NOP-certified operations. It can be found by clicking on “List of Certified Operations” 

under “Organic Certification and Accreditation.” You can search for “berries,” and the 

program will provide the names and contact information for hundreds of operations that 

grow organic berries. To search for a source in a particular geographic location, enter the 

country, State, or city in the applicable fields.

§ 205.606 Nonorganically produced agricultural products 

allowed as ingredients in or on processed products labeled 

as “organic.”

Only the following nonorganically produced agricultural products may be used 

as ingredients in or on processed products labeled as “organic,” only in accordance 

with any restrictions specified in this section, and only when the product is not commercially 

available in organic form.
Page 38 www.ams.usda.gov/nop Guide for Organic Processors

In addition, you can find a full list of certifying agents on the NOP Web site by clicking on 

“List of Certifying Agents” under “Organic Certification & Accreditation.” The NOP Web 

site address is www.ams.usda.gov/nop.

Also, some certifying agents have searchable databases listing their clients, which you 

can access online.

There are many distributors who will search for suppliers of organic ingredients, each of 

which serves a unique niche. For example, distributors may focus on processed foods, 

such as juice concentrates or herbs, or on such tropical ingredients as chocolate. Distributors may have a minimum order size, which might exceed the needs of small processors. 

Depending on the ingredients you’re seeking, it may take some time to locate a supplier and 

ensure that you have a steady supply of the quality ingredients you need. 

 Questions

•	 Have you found organic sources of all the agricultural ingredients in your organic products?

•	 If you are not able to locate a source for an organic ingredient, have you checked to see 

whether the item is listed in § 205.606?

•	 If you plan to use a nonorganic agricultural product, have you contacted several sources 

to verify that it is not available as organic? 

•	 Has your certifying agent confirmed your assessment of commercial availability? 

Notes 
Guide for Organic Processors www.ams.usda.gov/nop Page 39

CHAPTER 12

THE AUDIT TRAIL

As noted in § 205.103 above, organic farmers and handlers must maintain adequate 

records to document their organic handling activities. This system of records is 

called an audit trail. A good audit trail will allow you to track the organic product 

from the field where it is grown through harvest, storage, handling, processing, shipping, and 

final sale to the consumer. The inspector will review your documentation during the audit. 

If you don’t have a good recordkeeping system in place, the audit can be one of the most 

challenging parts of an organic inspection. If you do maintain adequate records, and 

you have them readily available for review, the audit portion of the inspection should 

proceed smoothly. 

This chapter explains the types of audits that certifying agents conduct and the types of documents that may be requested during the audits. You may not need all of these records, or you 

may need additional records. The recordkeeping system must be adapted to the operation. 

The types of audits

Your certifying agent’s inspector will choose the type of audit to be conducted and the 

product to be audited. During the audit, the inspector must review your documentation 

and be able to understand the purpose of each document. A thorough audit will ensure that 

all the relevant activities of your handling operation are recorded. Handlers who are new 

to organic certification may find that they need to prepare additional documents, or modify the ones they already are using, in order to keep records that are sufficient for an audit. 

You won’t have organic sales records at your first inspection, before you’ve sold any organic 

products, but you may be asked how you intend to record your organic sales.

There are three types of audits:

•	 Sales/financial audits

•	 Backtrack or trace-back audits

•	 Ingredients-in/products-out balance audit (in/out balance)

Financial audits

The financial audit verifies the sales of organic product and the income from the sales over 

a specific period of time. If you reported annual sales in your application paperwork, an 

§ 205.103 Recordkeeping by certified operations

(a) Certified operators must maintain records concerning the production, 

harvesting, and handling of organic products... 

(b) Such records must:

(1) Be adapted to the particular business that the certified operation is conducting;

(2) Fully disclose all activities and transactions ... in sufficient detail as to be readily understood and audited;

(3) Be maintained for not less than five years beyond their creation; and 

(4) Be sufficient to demonstrate compliance with the Act and regulations in this part.

(c) The certified operations must make such records available for inspection and copying 

during normal business hours by authorized representatives of ... the certifying agent.
Page 40 www.ams.usda.gov/nop Guide for Organic Processors

inspector may review documents from that year to understand how you calculated your 

annual sales and to verify that the information you reported is correct. 

To conduct a financial audit, the inspector will need invoices or other documents that show 

what you earned from sales of organic product. The quantity of product sold will be compared with the quantity produced, as well as with the income received from sales of the 

product, to verify that conventional product is not sold as organic. Some certifying agents 

calculate user fees based on the income from sales of organic products.

Backtrack audits

The backtrack audit, also called a trace-back audit, verifies that your documentation 

is sufficient to track organic products from the time they enter your possession until 

the time they leave your facility. To conduct a backtrack audit, the inspector will 

choose a lot code from a finished product and connect it back through the documents 

(the audit trail) to find the ingredients, purchased or produced, that were used to make 

the product. 

To prepare for this audit, look at your flowchart, which should diagram the flow of 

ingredients from the time they enter your facility to the time they leave as finished product. Assemble records related to purchasing raw ingredients, processing, selling finished 

products, and shipping. Remember to include records related to storing ingredients and 

finished products.

Ingredients-in/product-out balance audits

The ingredients-in/product-out balance audit verifies that organic ingredients were purchased or produced in sufficient quantity to make the organic products that were sold. To 

conduct this audit, the inspector will examine purchase orders and weight tickets to verify 

the quantity of ingredients purchased. Using your batch records and product formulations, 

the inspector will calculate the quantity of ingredients used in processing. The inspector will then compare the quantity of ingredients purchased with the quantity of finished 

product produced. The inspector also will review storage records to verify the quantities of 

ingredients and products in inventory. This is a complex audit, but it is fairly common for 

split operations and large operations. 

Types of audit-trail records 

These examples of audit-trail records are given in the order they would typically be 

generated from the time an ingredient enters the facility to the time it is sold. The organic 

products on each document should be clearly labeled “organic.” 

Receiving

•	 Purchasing invoices

•	 Purchase orders 

•	 Weight tickets 

•	 Storage records (ingredients)

Processing

•	 Production records 

•	 Batch records 

•	 Processing reports

•	 Storage records (finished products)
Guide for Organic Processors www.ams.usda.gov/nop Page 41

Sales

•	 Sales invoices

•	 Shipping records

•	 Bills of lading

•	 Annual sales totals

Lot numbers

Regardless of the type of audit conducted, the ability to track products through handling 

and processing is vital. Using lot numbers to track products can ensure a good audit trail. 

Each ingredient that is received in your facility should be assigned a lot number, which can 

be as simple as a date and product name. Any time that ingredients are blended, a new lot 

number must be assigned. For example, if you were making strawberry jam, you would 

record the lot number of the sugar, pectin, and other ingredients as they are received. 

When the jam is processed, a new lot number will be assigned to the finished jam. If you 

use only strawberries grown on your own farm, lot numbers may not be needed for the 

strawberries. If you purchase some of the strawberries, it will be important to note on the 

production sheet the source of the berries using a lot number or other tracking system. 

Many processors use lot numbers for quality-assurance purposes, both for the incoming 

ingredients and the finished products. If a production batch does not turn out as expected, 

evaluate the source of ingredients. Sometimes the problem can be traced to a specific batch 

of ingredients. Lot numbers can be used to facilitate a recall if there is a complaint or a 

food-safety issue after a product is manufactured and sold.

 Questions

•	 Can your records be easily understood and audited?

•	 Are records maintained to ensure a complete audit trail?

•	 Does your recordkeeping system permit accurate tracking of products from receiving 

through sales?

•	 Are the following records easily available?

— Purchasing invoices 

— Purchase orders 

— Weight tickets 

— Storage records (ingredients)

— Production records 

— Batch records 

— Processing reports
Page 42 www.ams.usda.gov/nop Guide for Organic Processors

— Storage records (finished products)

— Sales invoices 

— Shipping records 

— Bills of lading

— Annual sales totals

Notes 
Guide for Organic Processors www.ams.usda.gov/nop Page 43

CHAPTER 13

PREPARING FOR AN ORGANIC INSPECTION

Each organic farm or handling operation must be inspected at least once a year. The 

purpose of this annual inspection is to verify that the owner and employees are following the organic system plan (OSP) that was submitted to the certifying agent. 

In order to verify that the protocols are followed, they must be documented as part of the 

recordkeeping requirements for organic operations. Complete and adequate records are 

essential for ensuring organic integrity because they demonstrate compliance with organic 

standards. The certifying agent will notify the inspector if there were any compliance issues 

noted in the past and will ask the inspector to verify that those issues have been resolved.

An organic inspection may take only an hour for a storage facility, a few hours for a small 

processing plant, or a full day for a complex operation. The inspector will need enough 

time to cover several aspects of the operation:

•	 Visit all parts of the facility, including ingredient storage, processing, and finishedproduct storage

•	 Review all the questions on your OSP to verify that they are still correct and ask 

whether any changes have been made

•	 Confirm that any previous compliance issues have been resolved

•	 Conduct an audit

In addition to the annual inspection, which covers all aspects of your operation, you may 

receive an unannounced inspection. An inspector will visit your facility on short notice, 

perhaps a few hours or a full day. Typically, an unannounced inspection will be shorter 

than your annual inspection and will focus on a specific aspect of your operation, such as 

observing the processing operation or reviewing sales receipts.

Some people start preparing for an inspection after the inspector calls to set a date for 

the on-site visit. In reality, you are preparing for an inspection every time you purchase 

organic ingredients, process organic foods, or sell finished products. If you operate every 

day as if you were preparing for the inspection, completing paperwork and filing it as 

needed, you’ll be well prepared for the annual inspection. Equally important, you will be 

prepared for any unannounced inspections.

When preparing for the on-site inspection, consider the following:

•	 Personnel. Be sure that anyone involved with organic production, including 

receiving, production, sales, accounting, and filing, is available. Being available to 

answer questions and provide documents helps the inspector fulfill the responsibilities of the inspection and facilitates the renewal of certification. 

•	 Workspace. If possible, provide space for the inspector to set up a laptop and to 

review your audit-trail documents.

•	 Time. Allow several hours. The inspector will estimate the time needed, but 

inspections can require extra time if your recordkeeping system is incomplete or 

difficult to follow. 

•	 Audit trail. Have documents from the current year and the previous year readily available. Documents from earlier years may be requested as well—you are 

required to keep documents for 5 years.

•	 Records. Have copies of the records listed below.

Before the inspector arrives, let your employees know that it is important to interact with 

the inspector in a professional manner. Intimidating or harassing an inspector may cause 

Related ATTRA 

publications

www.attra.ncat.org

Preparing for an 

Organic Inspection: 

Steps and Checklists
Page 44 www.ams.usda.gov/nop Guide for Organic Processors

the inspection to be terminated, which can compromise your ability to complete the 

certification process.

Types of records

The inspector will need to look at all records pertaining to organic production. The following lists provide examples of the types of records that will typically be requested related to 

your facility, ingredients, and processing activities. In addition to these records, the audittrail records discussed in Chapter 12 should be readily available.

Correspondence 

•	 Application materials sent to your certifying agent

•	 Organic System Plan for Handlers sent to your certifying agent

•	 Correspondence from your certifying agent

•	 Correspondence to your certifying agent that explains corrective actions that were 

taken to resolve compliance issues

•	 Facility records 

•	 Facility map

•	 Pest management logs

•	 Records of cleaning and equipment sanitation 

Ingredient records 

•	 Organic certificates from suppliers of organic ingredients

•	 Records of tests to confirm that the water you are using is potable

Depending on your label claims and the type of ingredients and processing aids used in 

your product, you may need the following:

•	 Verification that nonorganic ingredients are not genetically modified [do not contain genetically modified organisms (GMOs)]

•	 Documentation of your search for organic ingredients when you are using nonorganic ingredients

Processing records 

•	 Product formulations or recipes

•	 Production flowchart

•	 Batch sheets or other records of production

•	 Sample labels

If the above documents are not available at inspection, you may be required to send them 

to the certifying agent before receiving your organic certificate. This will slow the renewal 

process and create more work for you and the certifying agent.

 Questions

•	 Do you retain all records applicable to your operation for at least 5 years?
Guide for Organic Processors www.ams.usda.gov/nop Page 45

•	 Are the following records easily accessible?

— Application materials sent to certifying agent

— Organic System Plan for Handlers sent to certifying agent

— Correspondence from your certifying agent

— Correspondence to your certifying agent addressing corrective actions to address 

any compliance issues

— Facility map

— Pest management logs

— Records of cleaning and equipment sanitation 

— Organic certificates from suppliers of organic ingredients

— Records of tests to confirm that the water you are using is potable

— Records that verify ingredients are non-GMO

— Documentation of your search for organic ingredients when you are using 

nonorganic ingredients

— Product formulations or recipes

— Production flowchart

— Batch sheets or other records of production

— Sample labels

Notes 
Page 46 www.ams.usda.gov/nop Guide for Organic Processors

CHAPTER 14

STORAGE AND PEST MANAGEMENT

This chapter covers two different, but related, topics: 

• Storing organic ingredients and processed produc

• Controlling pests in the buildings where organic products are stor

handled, or processed

Storage 

All buildings where organic crops are handled or stored must be listed on your organic 

system plan (OSP) and included in your facility map. If you store the ingredients or finished products away from your farm or processing facility, either those buildings must be 

under your control or the owners must have their own organic certification. Retail stores 

and other operations that have products packaged in sealed retail containers do not need 

to be inspected or certified because there is no danger of contamination.

Organic ingredients and products should be stored in a separate area away from conventional ingredients. All bins, shelves, and storage areas should be clearly labeled “organic” 

or “conventional.” If storage rooms include both organic and conventional products, the 

organic products should be stored in a manner that reduces the possibility of contamination or commingling with conventional products. 

One way to prevent commingling is to store organic products on upper shelves and conventional products on lower shelves. This practice can reduce the chances of commingling. 

For example, if an organic apple fell into a conventional lot, only that one apple would 

lose its organic status. If a conventional apple fell into an organic lot, however, it might 

be impossible to determine which apple was organic. This would mean that the whole lot 

would lose its organic status. 

Facility pest management

Section 205.271, which addresses pest control, applies to any buildings where organic product is stored, handled, or processed. Adequate pest management is essential to prevent food 

from becoming contaminated by insects, rodents, or other pests. Organic handlers follow 

a multi-level hierarchical approach when dealing with pests in storage facilities. The first 

level of control, Level A, is prevention of the problem. The second and third levels, Levels 

B and C, include physical and chemical controls. The fourth level, D, is available for use 

inside and around the outside perimeter of buildings if the organic products can be protected from contamination. 

If you contract with a pest-control company, be sure that the representative who 

services your facility is familiar with the USDA Organic Regulations. The company should 

implement measures to prevent pests and understand how to verify whether materials are 

allowed for pest control.

§ 205.271 Facility pest management practice standard

The facilities where organic products are stored must use management 

practices to prevent pests.
Guide for Organic Processors www.ams.usda.gov/nop Page 47

Level A

Prevention is the first line of defense. Keeping pests out of your facility saves time and 

money and reduces the need for further pest control. To prevent pests from entering a 

storage building, use screens on windows, keep doors closed, and make sure doors are well 

sealed when they are closed. 

Make your facility an unfavorable environment for pests. Remove food sources to 

prevent pest populations from increasing. Examples include sweeping up spilled grains 

or ensuring that food left in a lunchroom is in sealed containers. Inside your storage 

rooms, keep bins and boxes at least 12 inches from the walls. Set traps for rodents next 

to the walls. 

The area outside your facility should be kept clean and clear of debris so there are no places 

for rodents to hide. While they are attractive, shrubs or other plants next to the building 

also provide shelter for rodents, so you may wish to limit their use . If your processing 

operation creates food waste, such as corn husks, potato peels, or grape skins, the waste 

should be removed regularly so it does not attract flies or other insects.

Level B

The second line of defense, Level B, is the use of mechanical and physical controls. Level 

B practices include insect lights that attract and kill insects and mechanical rodent traps 

baited with food, such as cheese. 

Level C

The third line of defense, Level C, is to be used only after Level A and Level B have been 

applied. Level C practices include the use of materials on the National List of Allowed 

and Prohibited Substances, located in § 205.601 of the USDA Organic Regulations. Baits 

that kill rodents or insects are Level C practices. Examples include Vitamin D3 bait to kill 

rodents and diatomaceous earth placed in grain bins to kill insects. If you wish to use any 

pest-control materials, you must include the materials in your Organic System Plan and 

maintain records of their application in a pest-control log.

Level D

The fourth line of defense, Level D, may be used only if pest-control actions in 

Levels A, B, and C do not adequately prevent or control facility pests. Level D practices include the use of synthetic insecticides or rodenticides that are not on the 

National List. These substances are normally prohibited in organic agriculture. They 

may be used only as a last resort. Your certifying agent must approve the use of 

prohibited pest-control materials before they are used. Before approving a Level D 

application, your certifying agent will verify that you have already employed Level 

A, Level B, and Level C pest-control actions. Your certifying agent will review the 

substance to be applied, the method of application, and the measures to be taken to 

prevent contact with organic products.

Applications of pesticides required by law 

If Federal, State, or local laws or regulations require use of a prohibited pesticide, notify 

your certifying agent. Agree on a plan to ensure that measures are taken to prevent 

contamination of organic products. If your certifying agent has approved the practice, it 

will not compromise your organic status. 
Page 48 www.ams.usda.gov/nop Guide for Organic Processors

 Questions

•	 Does your OSP for handling include all buildings where raw ingredients or finished 

products are stored?

•	 If you store organic ingredients or products in buildings that are not part of your main 

operation, are the storage units either certified organic or included in your farm’s 

inspection and certification?

•	 Are storage facilities large enough to segregate organic and conventional products as 

needed?

•	 Where both conventional and organic products are stored, are the storage areas clearly 

marked and segregated from each other?

•	 Is each storage container or shelf clearly labeled “organic” or “conventional?”

•	 Are prohibited materials (fuels, pesticides, etc.) stored well away from organic foods?

•	 If you have contracted a company to manage your pest control, have you notified the 

company that it must comply with USDA Organic Regulations?

•	 Have you taken measures to prevent pests from entering your processing facility?

•	 Have you taken measures to discourage pests, including removal of food and shelter?

•	 Are all pest-control products allowed for organic use?

•	 If you were obliged to use a synthetic pest-control material, did you obtain approval 

from your certifying agent?

•	 If you are using pest-control products, is their use recorded in a pest-control log?

Notes 
Guide for Organic Processors www.ams.usda.gov/nop Page 49

CHAPTER 15

RESOURCES

The following resources provide information on organic regulations, the organicproducts industry, and food-safety regulations. This list is not intended to be exhaustive. There are many additional resources available, notably in the areas of business 

management or government programs for small business. 

Accredited Certifiers Association, Inc.

www.606organic.com

 The Accredited Certifiers Association, Inc., is a nonprofit organization open to certifying agents and others in the organic community. It administers the Web site 606organic, 

which lists suppliers of organic forms of the agricultural ingredients in § 205.606 of the 

USDA Organic Regulations. The nonorganic ingredients may be used only when an 

organic form is not commercially available. 

Agricultural Marketing Resource Center (AGMRC)

www.agmrc.org

 AGMRC is a national electronic resource for producers interested in value-added 

agriculture. The site provides information on marketing and business development plus a 

directory of resources for each State. 

ATTRA

www.attra.ncat.org

 ATTRA (Appropriate Technology Transfer for Rural Areas) is managed by the National 

Center for Appropriate Technology. ATTRA, also called the National Sustainable 

Agriculture Information Service, provides information about sustainable agriculture via 

toll-free helplines, publications, webinars, and an extensive Web site. The publications 

can be downloaded from the ATTRA Web site or you can call the ATTRA helpline to 

request a print copy. ATTRA’s English-language helpline number is 800-346-9140; the 

Spanish-language helpline number is 800-411-3222.

Selected ATTRA publications:

Adding Value to Farm Products: An Overview

Guide to Organic Crop Production

Guide for Organic Livestock Producers

Organic Standards for Handling (Processing)

Small-Scale Egg Handling

Small-Scale Poultry Processing

Legal Issues for Small-Scale Poultry Processors

eOrganic

www.eorganic.info

 eOrganic provides information to the agriculture community in the form of articles, 

videos, and webinars. The link to Entrepreneurs & Their Communities has resources for 

value-added farm products. 

The information presented in this chapter is intended as a helpful reference. It is for information purposes only and inclusion in this list does not constitute endorsement by USDA. It is 

the user’s responsibility to verify the accuracy of any information.
Page 50 www.ams.usda.gov/nop Guide for Organic Processors

Food and Drug Administration (FDA)

The U.S. Food and Drug Administration oversees various processing activities. 

Overview of FDA programs

www.fda.gov/Food/default.htm 

Regulations for food-service establishments

www.fda.gov/food/FoodSafety/RetailFoodProtection

 Federal requirements for food labeling 

 www.fda.gov/Food/LabelingNutrition/default.htm 

 Finding the State agency responsible for issuing food-processing licenses

 www.fda.gov/Food/FoodSafety/RetailFoodProtection/FederalStateCooperative

Programs/ucm122814.htm

National Center for Appropriate Technology (NCAT)

www.ncat.org

 The National Center for Appropriate Technology is a national nonprofit organization that 

offers programs in sustainable agriculture, sustainable energy, and community development. One of the sustainable-agriculture programs is ATTRA, listed above.

Natural Food Network

www.naturalfoodnet.com

 The Natural Food Network hosts a Web site that provides “business insight for natural and organic buyers.” Its marketplace tab is a searchable database to find ingredients, 

co-packers, consultants, and other items you may need for your business.

Non-GMO Sourcebook

www.nongmosourcebook.com

 The Non-GMO Sourcebook is a buyer’s guide to suppliers of ingredients that do not contain genetically modified organisms (GMOs). Be aware that the publisher of this list does 

not verify the non-GMO claims of the suppliers. It is the responsibility of the buyer to ask 

for documented proof of the non-GMO claims.

Organic Materials Review Institute (OMRI)

www.omri.org

 The Organic Materials Review Institute provides an independent review of products 

intended for use in organic agriculture and processing. The OMRI list of allowed products can be found on its Web site. 

Organic Processing Magazine

www.organicprocessing.com

 Organic Processing Magazine has articles on organic regulations, business planning, 

industry trends, and profiles of people and companies. Some articles are geared toward 

large processors, but many are of interest to the entire organic community. The magazine 

is available for free.

Organic Trade Association (OTA)

www.theorganicpages.com

www.HowToGoOrganic.com

 The Organic Trade Association is a business association geared to wholesaling of organic 

products in North America. It maintains The Organic Pages Online, a database where 

you can search for suppliers of organic ingredients. It also maintains a Web site that offers 

information on the transition from conventional to organic farming and processing. 
Guide for Organic Processors www.ams.usda.gov/nop Page 51

Small Poultry Processing Plants and Services

www.attra.ncat.org/attra-pub/poultry_processors

 Small poultry processing plants and services are listed on this database maintained 

by NCAT.

Sustainable Agriculture Research and Education (SARE) 

www.sare.org

 SARE promotes research and education to improve profitability and sustainability of 

farms. SARE’s learning center contains books, videos, online courses, and fact sheets. 

The publications are typically national in scope and provide a thorough review of the 

subject. SARE also provides grants to farmers, researchers, and extension personnel to 

conduct on-farm research. 

USDA Business and Industry Guaranteed Loans (B&I)

www.rurdev.usda.gov/rbs/busp/b&i_gar.htm

 USDA administers the Business and Industry (B&I) Guaranteed Loan Program to help 

establish, expand, or modernize rural businesses. The B&I Guaranteed Loan Program is 

a general-purpose economic development program that can be used for a wide range of 

projects. Loans eligible for a guarantee can range in size up to $25 million; the percentage of the loan that is guaranteed varies depending upon the size of the loan. The B&I 

Program requires the participation of an eligible lender.

USDA Cooperative Extension Service 

www.csrees.usda.gov/Extension

 This Web site provides links to State Cooperative Extension offices. From there, you can 

find telephone numbers of county offices, local workshops on food-safety regulations, 

and other resources as provided by your State.

USDA National Organic Program (NOP)

www.ams.usda.gov/nop

 The mission of the National Organic Program is to ensure the integrity of USDA organic 

products in the United States and throughout the world by implementing the Organic 

Foods Production Act. Its Web site has a link to the electronic Code of Federal Regulations applicable to organic production and handling, a list of accredited certifying 

agents, a list of all certified organic operations, and a wealth of other information. The 

Program Handbook, which can be downloaded from the Web site, provides guidance to 

help operations and certifying agents comply with USDA organic regulations. The NOP 

also administers a cost-share program, reimbursing eligible operations for as much as 75 

percent of their certification costs—up to $750 per year. You can subscribe to the NOP’s 

electronic updates, the NOP Organic Insider and the Organic Integrity Quarterly.

Current guidance documents for handling:

• Guidance: The Use of Chlorine Materials in Organic Production and Han

• Draft Guidance: Handling Bulk, Unpackaged Organic Pro

USDA Reimbursement Transportation Cost Payment (RTCP) 

Program for Geographically Disadvantaged Farmers and Ranchers

www.fsa.usda.gov/Internet/FSA_Notice/sp_53.pdf

 RTCP provides assistance to geographically disadvantaged farmers and ranchers. The 

program reimburses producers for a portion of the transportation cost of their agricultural commodity or transporting inputs used to produce an agricultural commodity 

during a fiscal year. RTCP is subject to appropriated funding.
Page 52 www.ams.usda.gov/nop Guide for Organic Processors

For more information, please contact the 

USDA National Organic Program:

 National Organic Program

Agricultural Marketing Service

U.S. Department of Agriculture

1400 Independence Avenue, SW

Stop 0268, Room 2648-S

Washington, DC 20250-0268

Tel. 202-720-3252

Fax 202-205-7808

www.ams.usda.gov/NOP

This publication is available online at:

www.attra.ncat.org

or by calling NCAT’s ATTRA project: 800-346-9140

IP421

Slot 414

The U.S. Department of Agriculture (USDA) prohibits discrimination against its customers. If you believe you experienced discrimination when 

obtaining services from USDA, participating in a USDA program, or participating in a program that receives financial assistance from USDA, 

you may file a complaint with USDA. Information about how to file a discrimination complaint is available from the Office of the Assistant 

Secretary for Civil Rights.

To file a complaint of discrimination, complete, sign and mail a program discrimination complaint form, available at any USDA office location 

or online at www.ascr.usda.gov, or write to: USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue, S.W., 

Washington, D.C. 20250-9410.

Or call toll free at (866) 632-9992 (voice) to obtain additional information, the appropriate office or to request documents. Individuals who are 

deaf, hard of hearing or have speech disabilities may contact USDA through the Federal Relay service at (800) 877-8339 or (800) 845-6136 (in 

Spanish). USDA is an equal opportunity provider, employer and lender.

Persons with disabilities who require alternative means for communication of program information (e.g., Braille, large print, audiotape, etc.) 

should contact USDA’s TARGET Center at (202) 720-2600 (voice and TDD). 

USDA Value Added Producer Grants

www.rurdev.usda.gov/BCP_VAPG_Grants.html

 The Value Added Producer Grant program, administered by the USDA, is a competitive 

grants program. The funds (up to $300,000) are available to farmers who want to develop 

a value-added product from a crop that they grow. Funds may be used for feasibility studies or business plans, working capital for marketing value-added agricultural products, 

and farm-based renewable-energy projects. 

Washington State Department of Agriculture (WSDA) 

www.agr.wa.gov/FoodAnimal/Organic/MaterialsLists.aspx 

 The WSDA Organic Food Program reviews materials allowed in organic production and 

publishes the WSDA Brand Name Materials List on the Web. 

Articles

Theuer, Richard. 2012. Nonprocessing Handling: Navigating the Gray Regulatory Area 

Between the Farm and the Factory. Organic Processing, Vol. 9, No. 1.