Additions and updates to processing certification
#Move or add a facility
How do I add a new facility?
Start with a complete review of your Organic System Plan (OSP). Identify any changes you will need to make due to the facility addition or move to a new location (e.g., facility information, pest management, water and sanitation practices, etc.).
All situations are unique. It’s a good idea to contact us early in your planning process. We’ll help identify potential issues, and coordinate with our certification and inspection teams.
Here is the basic info we’ll need to get started:
- Purchase of any new equipment
- System upgrades or changes in procedures
- A detailed facility description and map
- Timeline for construction, equipment installation, records transfer, and desired production start
Depending on your changes, you’ll need to fill out different forms to update your OSP.
In the event a business is purchased or a merger occurs, the new owner must re-apply for organic certification and complete inspection under the new legal business entity. An inspection must occur even if the previous inspection happened less than a year ago.
Which forms will I need to update?
You will need to complete the Facility Information form (H2) and document if there are any process flow changes.
Next, review your plan to look for areas you may need to update such as practices for shipping and receiving, sanitation, and pest management. Depending on what you find, you may need to update the H3, H5, H6, H7 and H8 forms.
If the business at the address in your Contract and Operation Information (O1) forms is closing, each form will need to be updated. Additionally, we’ll need notification if the certification of the previous facility location is to be surrendered.
Forms & Documents
O1 Operation Information
H2 Facility Information
H3 Product Summary
H6 Receiving, Storage, Packaging, and Shipping
H7 Facility Pest Management
H8 Recordkeeping Practices
Download the above and submit it to your client service team.
Will my facility addition require an inspection?
Yes, adding or moving to a new facility always requires an inspection.
We recommend providing us with as much advance notice possible — at least four to six weeks — for scheduling and minimizing costs.
Can I process product(s) at my new facility before my inspection?
An operation in good certification standing may be eligible to begin organic production prior to inspection, final review, and certification only if all products remain on site.
You must maintain the appropriate records to prove eligibility through the final review and certification of the facility. However, any pre-inspection and pre-certification production runs the risk of not being verified as organic, and will not be permitted for organic sale or representation.
#Adding new labels and label revisions
Check out our Labeling and Composition Guide to learn more about requirements that differ depending on the “organic-ness” of your product(s).
When do I need to submit labels for review?
Each time you add a new label or make changes to an existing product label, you must submit your label to OTCO for review and approval prior to use.
We advise against printing unapproved labels in all circumstances. Using a non-compliant label can result in the loss of product sales, recalls, and certification suspension.
Can I use templates for my bulk labels?
OTCO may be able to accept a label template for use and application on bulk labels, but we require that updates or new bulk label templates be submitted for review and approval prior to use.
Can I get my labels pre-approved before I am certified?
We can review and issue pre-approval of a label if you’ve submitted an Organic System Plan (OSP) or product addition for review.
Please note the approval will only verify that the label itself is compliant with the standards. A thorough review (e.g., ingredient verification, formulation, etc.) of your OSP is required to determine if the product is compliant. It’s possible that the review of your product, and subsequent needed changes, might require a revision to your label.
Can I get labels pre-approved for my new product?
Yes, we can review and issue pre-approval of a label if you’ve submitted a product addition request, but the approval will only verify the compliance of the label. Your product is still subject to review and make require a revision to your label.
What are labeling requirements do I need to follow?
We’ve outlined the requirements for specific certifications in our Labeling and Composition Guide. However, in all cases, it is important to ensure that the ingredients on your label match (exactly) the ingredients listed on your Product Formulation Sheet and Master Ingredient List.
Once you finalize your label, submit it to your client service team for review and approval prior to use.
#Add a new product to certification
Over the lifecycle of processing your product(s), it’s likely you’ll need to add a new ingredient or a new supplier of the same ingredient. When this happens, we’ll need to update your Organic System Plan (OSP) to reflect the proposed changes and ensure compliance of your supply chain.
For internationally sourced ingredients, review our international imports policies and protocols for at-risk ingredients.
How do I add a new organic ingredient?
If your supplier is already approved…
You will only need to update your Master Ingredient List and your supplier certificates. However, you will need to document, organize, and present all of your suppliers’ records at your inspection.
If you are using a new, unapproved supplier…
You will need to submit the supplier’s certificates to OTCO for approval prior to use in order to avoid potential invalidation and loss of sales in the event of any verification issues.
How do I add a new non-organic ingredient?
There are a few extra steps for using an allowed non-organic ingredient.
To start, submit all non-organic ingredients to OTCO for approval prior to use, including the manufacturer’s full list of ingredients and/or processing aids that went into creating the ingredient. You must also submit a Non-Organic Ingredient Declaration (NOID) to ensure the ingredient was not produced using organic excluded methods (with a few exceptions outlined below).
- If your non-organic ingredient has commercial availability restrictions…
You will need to demonstrate an organic version is unavailable through the completion of a Commercial Availability Form.
- If your non-organic ingredient is a natural flavor…
You must submit a Natural Flavor Questionnaire (in place of a NOID), and verify it is produced using only approved methods or following restrictions per the organic requirements. Additionally, use of non-organic natural flavors requires a Commercial Availability Form (see March 2019 Notice).
- If your non-organic ingredient is a nutrient, vitamin or mineral…
You will complete the Declaration for Nutrient Vitamins and Minerals in place of the NOID, as well as verification it is produced using only approved methods.
#Add new supplier or new ingredient
Over the lifecycle of processing your product(s), you will likely need to add a new ingredient or a new supplier of the same ingredient. We need to update your Organic System Plan to reflect proposed changes and maintain traceability of your organic products and ensure compliance throughout your supply chain.
While changing suppliers does not require an additional inspection, you will need to document, organize, and present all of your suppliers’ records at your inspection.
Adding a new *organic* ingredient
- If your supplier is already approved…
Update your Master Ingredient List and your supplier certificates
- If using a new, unapproved supplier…
Submit the supplier’s certificates to OTCO for approval prior to use in order to avoid potential invalidation and loss of sales in the event of any verification issues
Adding a new *non-organic* ingredient
If your ingredient will be sourced internationally, you must review our international imports policies and protocols for at-risk products.
- Submit all non-organic ingredients to OTCO for approval prior to use, including the manufacturer’s full list of ingredients and/or processing aids that went into creating the ingredient
- For all non-organic ingredients with commercial availability restrictions, you must demonstrate an organic version is unavailable through completion of a Commercial Availability Form
- For (many) allowed non-organic ingredients, you must submit a Non-Organic Ingredient Declaration to ensure the ingredient was not produced using organic excluded methods
- For non-organic natural flavors, vitamins or minerals, complete either the Natural Flavor Questionnaire or Declaration for Nutrient Vitamins and Minerals
#Importing into the U.S.
There may be times when you need to look to international suppliers while sourcing organic ingredients, feed, or products. It’s important to understand the regulatory requirements for all imports of certified organic ingredients and feed to comply with international organic trade requirements.
What steps should I take before importing from abroad to the U.S.?
- Review OTCO’s import policy
- Check that the international product you wish to import has proper organic certification and documentation, meaning it must have USDA National Organic Program (NOP) certification or be covered under an equivalency arrangement
- Review the country of origin’s trade and/or equivalency arrangement with the USDA NOP
- Collect and organize necessary records for each shipment (i.e., a USDA NOP import certificate)
- Review the USDA’s organic imports factsheet