Certifiably Organic: What to Expect When You’re Inspected

By Joe Montecalvo, Ph.D.


The road to achieving organic certification can be long and arduous. For those unfamiliar with the intricacies of the U.S. Department of Agriculture’s National Organic Program (USDA NOP), it is a complicated and daunting journey, requiring the completion of many steps before certification can be granted. Experience shows that the more educated the applicant is before beginning the process, the faster and more painless it will be.

Central to the issue of organic process certification is the on-site inspection audit conducted by an inspector selected by the certification agency. The processor’s application for organic certification typically is based on the company’s organic handling or systems plan, which describes and documents how organic products are formulated, received, processed and stored. The application also includes information describing the company’s sanitation, pest management and audit tracking operations.

For those producers and processors who enter into this process, the rewards of organic certification are many. Knowing what to expect when you’re inspected will prepare your company to successfully navigate—and benefit from—the organic certification process.

Organic Inspection Overview
The USDA empowers certification agencies through its accreditation program to certify companies in accordance with the NOP, the nation’s federal organic certification and labeling regulations and standards (7 CFR part 205). The certifier develops the application materials to meet the requirements for certification, which are forwarded to the company seeking certification for completion.

Once the documents are completed and reviewed, an inspector contacts the potential client to set up a mutually agreed upon inspection date and time so that all key in-house personnel are available to attend the inspection. The primary objective of the inspection is to verify the accuracy of all client information provided in the application and to report back to the certification agency any potential areas of noncompliance with the NOP.

Prior to the inspection, the in-house contact person should review the details of the NOP to have a better understanding of the legal requirements of both the inspection and certification process. Once the inspection date is set, the process begins. There will be many details to review and documents to complete for the inspector to record and verify all of the information provided in the application for certification.

Following is a detailed review of what the inspection process covers. It illustrates the type of questions that may be asked, what documentation may be needed, and potential references to the NOP that are helpful along the way.

Organic Products
The first section of the organic certification application asks the applicant to identify what products are being proposed for certification. Documentation must include all ingredients by weight and their percent in the product, minus any amounts of water and salt. Additionally, valid certificates for each organic ingredient must be available and attached to the application or available on-site. The inspector will verify all products, ingredients and certificates in accordance to 7 CFR parts 205.300 and 205.301. Additionally, the inspector will verify the percent of organic ingredients in each product, which is essential for documentation of each product on the basis of the “100%,” “certified organic” or “made with” categories as they will appear on the certification certificate.

Additionally, the inspector will verify if any processing aids are used. All processing aids must be in compliance with 7 CFR part 205.605, are certified organic and/or are approved as having no prohibited substances by the Organic Materials Review Institute (OMRI). If there is any question on the approval status of processing aids or non-organic ingredient usage, the client should always check with the certifier. All non-organic ingredients will be verified by the inspector as being non-GMO, not subjected to ionizing radiation and not grown (if applicable) with sewage sludge as a crop fertilizer.

Receiving, Shipping and Storage
Next, the inspector will verify how organic ingredients or products are received on-site. For example, inbound organic ingredients should be labeled as organic for immediate in-plant identification and recorded on receiving logs as organic. In some cases, clean truck affidavits must verify that inbound transport of organic ingredients or products were not contaminated by residue left from previous transport. This is especially important in the bulk transport of organic milk, oil, wine, juice and other liquid organic products.

On-site storage of organic ingredients and products will also be verified by the inspector. In most cases, storage is either dedicated organic or segregated. The inspector will verify that all organic ingredients and products can readily be distinguished from on-site non-organic ingredients. Therefore, the organic handling plan or systems plan must document all receiving and storage operations to facilitate inspector on-site verification.

Outbound shipping of organic products should also be documented on the handling plan or application. Shipping should document how finished organic products are stored and transported to customers, further processing, or off-site third-party storage.

All certifiers have an independent storage information document or equivalent, which is used to verify the conditions of storage of organic products at facilities that provide holding services for certified organic products. The inspector will want to review and verify this document during the inspection to insure minimal risk of contamination from sanitation and pest management operations.

Processing
During the inspection, the inspector will review all process flow diagrams and site diagrams, that usually are attached to the application or organic handling plan. The inspector should review each unit operation to insure organic integrity is maintained during processing and production. The inspector will also ask for a plant tour, usually after reviewing all application information to verify all handling and process operations from receiving of organic ingredients to outbound shipment of organic products.

During process line inspections, if steam is used for heating operations the inspector will want to document and verify whether boiler additives are used. Use of boiler additives is of concern only when there is direct steam contact as may be found in steam sparging, extrusion, capping-lidding, and other unit operations that require rapid heating methods. Of particular concern is the use of volatile amine boiler compounds in the boiler additive formulation. These additives are volatile and can be transferred via the steam, potentially contaminating the product being heated or processed where there is direct steam contact.

Typical boiler additives are the neutralizing amine, morpholine, and the film forming amine octyldecylamine. Neutralizing amines are designed to neutralize dissolved carbon dioxide in the steam to lower its pH, which in turn slows down the rate of corrosion in steamline transfer pipes. Film forming amine additives will coat the interior walls of steam lines to protect the pipes from oxidation. Therefore, documentation of the use of boiler additives will require copies of Material Safety Data Sheets (MSDS), which are used by the inspector to verify if volatile amines are present in the boiler formulation.

If volatile amines are used the client needs to either document shut off prior to scheduled organic process operations or show by testing and analysis that there are no residues in the product. It should be noted that use of volatile amine boiler additives are approved per 21 CFR but have been reviewed by the National Organic Standards Board (NOSB). As of this writing use of volatile amine additives are not compliant with 7 CFR 205.605.

Additionally, the inspector will verify how on-line contamination or commingling will be avoided. The inspector will want to verify if dedicated first-run operations are used for scheduling organic production runs. In most cases, food processors will use this scheduling operation if possible to avoid mid-day line cleaning and sanitation operations prior to commencement of organic production operations.

Packaging
The inspector will review all retail labels submitted by the applicant to determine if the labels are compliant with 7 CFR 205.303. Therefore, label design should be approved by the certification agency prior to full printing. Additionally, the inspector will want to verify that all packaging materials are stored in an area that is not fumigated or fogged with residual pesticides or insecticides. A dedicated section of the dry warehouse or other suitable location of storage may be necessary to ensure that packaging materials do not become contaminated.

Sanitation
All sanitation operations should be written in the form of Standard Sanitation Operational Procedures (SSOPs), documenting how equipment is cleaned and sanitized. In most cases, sanitation operations will consist of an initial rinse, followed by an alkali cleaning operation, followed by a rinse, followed by application of a sanitizer. The inspector will want to review all sanitation operations and materials used. According to 7 CFR 205.605, all chlorine sanitizers, ozone and hydrogen peroxide sanitizers are approved for use in organic processing facilities. The NOSB has approved peroxyacetic acid but it has not yet appeared in 7 CFR 205.605; therefore, as of this writing, it is not compliant with the NOP.

Quaternary ammonium sanitizers are not approved for use in organic process operations since they function as a residual sanitizer. If quaternary ammonium sanitizer must be used for food safety reasons, the client must document removal prior to commencement of organic production operations and verified by the inspector.

As in the case of all sanitizers used, the applicant or client must demonstrate that any sanitizer left on production line and food contact surfaces and equipment does not contaminate organic products. This can be achieved by using fresh water rinse operations, evaporation to dryness (i.e., for chlorine sanitizers) or through the use of organic product purge operations. If purge operations are used, the inspector will want to verify the disposition of the purged material and sanitation logs used to verify all fresh water rinse and/or purge operations. Sanitation logs must be maintained to document all fresh water rinse operations and/or any additional operation used to ensure that organic products are not contaminated with residual sanitizer.

Pest Management
Pest management operations must be documented on the application or organic handling plan. It is up to the applicant or client to have the necessary documentation in the form of chemical pest control usage logs and inventory records ready for inspector review during the inspection.

The inspector will want to verify all prevention practices and use of physical and chemical control measures. A pest management map should be available for inspector verification that shows the physical location of all pest management control measures, such as tin cats, insect electrocution units, pheromone traps, Katch-Alls and exterior bait stations. At present, the USDA, per 7 CFR has approved only Vitamin D3 for use in exterior bait stations. However, if rodent pressure is of concern in the location of the plant facility, a letter of justification from an outside pest contractor for the use of anti-coagulant rodenticides may be submitted to the certifier for approval.

The inspector will also want to verify that any use of fogging or fumigants does not contaminate organic ingredients, packaging materials or finished products. In most cases, scheduling of chemical pest control usage when organic ingredients and products are not on-site may be the most cost-effective approach. If this is the approach used, the inspector will want to verify dates of chemical pest control application and require proof that no organic inputs or products were on-site on that date.

Recordkeeping and Audit Tracking
At the heart of the organic inspection process is the audit track, which enables the company and the inspector to trace back to its source every organic and non-organic ingredient for each product. To conduct this audit, the inspector will require all documentation generated, from receiving to product formulation, through processing such as batch records and daily production summary reports, through outbound BOLs, or the equivalent records. For companies with a Hazard Analysis and Critical Control Points (HACCP) plan and product recall process, documents associated with these programs may also be applied to organic traceback operations. These can show how product codes can be tracked to production dates and how ingredient lot codes can be tracked to individual suppliers. For example, an inspector will request to track one or more production runs from receiving to outbound shipment. From a document control point of view, all records should identify ingredients and products as “organic” with appropriate lot numbers, item numbers, product codes or any other tracking parameter that clearly links each document in the audit track.

In many cases, the inspector will ask for copies of the audit track to use as supporting documentation for his or her report to the certifier. Additionally, the inspector will want to conduct an ingredient in-product out analysis using production and ingredient use quantities with production yields for the product being audited.

Overall, it is the responsibility of the applicant or client to clearly show sequential documents used in the tracking process and all tracking parameters on the application so that the inspector will have some knowledge of the documentation prior to the inspection. This can greatly facilitate the audit process.

The Inspector’s Report to the Certifier
It is important to understand that all information reviewed and/or copied documents are maintained under strict confidentiality requirements. The inspector will gather all information and submit a narrative report to the certifier along with any documentation. The certifier will review the report in conjunction with the application or organic handling plan and determine if any additional information is required or if there are any areas of noncompliance. It is the responsibility of the applicant to respond to the certifier, typically within two-to-three weeks, to address all issues that arise during the inspection process. Also, the certifier will provide both a copy of the inspection report and an evaluation to the inspector to obtain input for their quality management operations.

Final Thoughts
The organic inspection process is designed to ensure that all applicants meet the requirements of 7 CFR part 210, as mandated by the USDA. As stated earlier, the process can be arduous, but in working with certifiers and their clients in the past 10 years as an inspector, successfully completing this phase of organic certification has given many companies a great sense of accomplishment and satisfaction in achieving their organic process certification goals.

Joe Montecalvo, Ph.D., worked as an inspector for both California Certified Organic Farmers (CCOF) and Oregon Tilth Certified Organic (OTCO), and as a consultant to companies pursuing organic certification. He is a professor of food science at Cal Poly in San Luis Obispo, CA, where he teaches food plant sanitation, pest management and food chemistry. He has served on subcommittees of the NOSB, providing expertise in food plant sanitation chemicals and food process operations. He can be reached at monetecalvo@charter.net.