25-0004_Attachment_1,_OIM_Inspection_Criteria.pdf

California Department of Food and Agriculture Inspection Criteria: OIM Manufacturers

ATTACHMENT 1

Criteria for Inspection Services

Organic Input Material (OIM) Manufacturers

I. Training

Contact Nicole Smith via email at nicole.smith@cdfa.ca.gov to arrange for inspector training with the California Department of Food and Agriculture (CDFA).

Online training may be available for international staff or when circumstances dictate.

II. Protocol - Prior To Inspection

1. Schedule the inspection and ensure that the date coincides with OIM production at the facility.

2. Email a blank copy of the Organic Input Material (OIM) Inspection Audit (or OIM Follow-Up Inspection Audit for the second annual inspection) document to the firm.

3. Email the Required Documentation for OIM Inspection to the firm to allow preparation of the documents in advance.

4. Email Luz Roa at luz.roa@cdfa.ca.gov at CDFA with the date, time, and location of the inspections, no less than 14 calendar days (but preferably at least 30 days) in advance of each inspection.

o In reply, Luz Roa or another CDFA Environmental Scientist will send an Organic Input Material Pre-Inspection Summary, the firm’s previous Organic Input Material Inspection Audit (if applicable), the firm’s confidential Organic Input Material Formula Sheet for the witnessed product in production, as well as copies of approved product labels for distribution in California.

o The Organic Input Material Pre-Inspection Summary will include information regarding the firm’s contact information, licensed locations, product registrations, mill assessments, tonnage reporting, as well as any action items required during the inspection.

o Guidance will be provided as to whether a sample will need to be collected for lab analysis.

5. Create an Organic Input Material Inspection Audit electronic file specific to the firm to be inspected. Audits should be saved according to the following naming convention: Firm name - CDFA Organic Input Material Inspection Audit – mailto:nicole.smith@cdfa.ca.gov mailto:luz.roa@cdfa.ca.gov mm.dd.yy or for follow-up inspections: Firm name – CDFA OIM Follow-up Inspection– mm.dd.yy.

6. Using the Organic Input Material Pre-Inspection Summary, enter the firm information into the Organic Input Material Inspection Audit (i.e., firm name and contact information, status of fertilizing materials license, product registrations, mill assessments, tonnage reporting, etc.).

III. Protocol – Day of Inspection

1. Introduce yourself to the firm, state the contractor you work for, and explain that you are a third-party entity charged with performing the OIM inspection on behalf of CDFA.

2. Thoroughly review the firm’s paperwork compiled for the Required Documentation of OIM Inspection and initiate the audit using the Organic Input Material Inspection Audit (or OIM Follow-Up Inspection Audit) document and CDFA OIM Inspection Protocol.

3. Tour the facility, observe OIM manufacturing process (from start to finish), and document precisely what you witness on the Organic Input Material Inspection Audit (or OIM Follow-Up Inspection Audit) form.

4. Obtain sample(s) for laboratory analysis of the material(s) witnessed during manufacture, as prompted by CDFA in the pre-inspection summary.

5. Contact Nicole Smith via email at nicole.smith@cdfa.ca.gov immediately, if the firm or products do not appear to comply with United States Department of Agriculture (USDA) National Organic Program (NOP) standards.

IV. Protocol –Inspection and OIM Inspection Audit Report

A. License, Registration, & Labeling

1. Document any compliance issues from previous inspections. If this is your first inspection, information will be provided by CDFA in the pre-inspection summary.

2. Report whether compliance issues have been addressed.

3. From the information provided by CDFA, document if the firm:

a. Possesses a California fertilizing materials license.

b. Is up to date with mill assessments and tonnage reporting.

4. Determine whether any of the firm’s products have been denied a product registration/certification or issued a noncompliance notice by any material review organization relating to products for use in organic food and crop production within the previous three years.

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• If denied or noncompliant, record the:

o Name of the material review organization o Product(s) involved o Issue(s) resulting in denial or noncompliance

5. Confirm whether or not all of the firm’s OIM products are registered with

CDFA and list any unregistered OIMs.

o Identify the number of finished OIMs manufactured or guaranteed by the firm.

o Identify the finished OIMs manufactured at the inspection location.

6. Document and verify whether:

a. A label is affixed to, or accompanies, the OIM being distributed.

b. Bulk material and storage areas are clearly labeled and designated for specific commodities.

7. Obtain actual production labels for all registered OIMs produced at the inspection location.

• Identify any OIM labels that do not match the registered label on file with CDFA and clearly describe what does not match.

• For differing labels, instruct the firm to complete a Registration Update Form at the web address provided within the OIM Inspection Audit.

B. OIM Ingredients

1. Verify that each incoming ingredient of OIM is accompanied by documentation identifying the origin and quantity (i.e., invoices, bills of lading, purchase orders, delivery tickets, or weight certificates).

• Obtain proof of purchase documentation for each ingredient used in OIM production.

• Identify each OIM ingredient, the manufacturer/supplier, the date of purchase, and any applicable comments.

2. Document and verify whether:

a. OIM ingredients are stored in original containers (not applicable to bulk material) and lot integrity is preserved.

b. OIM ingredients are received, handled, and stored in a manner to prevent commingling or contamination. Verify that OIM ingredients appear to be free from visible signs of cross-contamination from adulterants.

c. OIM ingredients may contain binders, wetting agents, antioxidants, dust suppressants, anti-caking agents or flow agents, defoamers, odor control, or similar ingredients.

• If any OIM product(s) contain such additives, list them.

C. Cleanout Procedures & Process Parameters

Document and verify whether:

1. Cleanout procedures are in place to prevent adulteration of OIM (sequencing, captured dilute solutions, flushing, and physical).

• Obtain cleanout procedure documentation, if available.

• Identify the cleaning material and describe any removal process (e.g., triple rinse, air dry, compressed air, etc.), if applicable.

2. Equipment cleanout is verified and documented.

a. Obtain a copy of the cleanout log, if available.

3. Trucks are inspected for possible cross-contamination prior to bulk loading, if applicable.

4. Determine if the OIM production process requires certain specialized parameters to comply with NOP, such as time/temperature logs for compost, temperature monitoring documentation for processed manure and pellet mills, and pH adjustment for fish fertilizer.

• If the firm requires specialized parameters, obtain documentation, and verify compliance.

• Describe any additional process parameters.

5. If the firm produces compost, vermicompost, compost teas, liquid fish products, and microbial products:

a. If applicable, obtain a copy of the most recent pathogen analysis report and ensure that the report has analysis for both fecal coliform and Salmonella.

b. Determine if pathogen analysis reports are within tolerance (3 MPN

Salmonella/4g and 1000 MPN fecal coliforms/g).

D. Production

1. CRITICAL: Identify the product witnessed during production and describe the manufacturing process.

a. Document your observations; do not rely on the printed production process.

2. Document and verify whether:

a. Production records are maintained to verify the product, sequence, and quantity produced.

• Obtain a complete and traceable history of the witnessed production.

b. OIM products are manufactured using either a master formula or batch sheet that includes the appropriate weight or volume of each ingredient, as well as mixing steps, times, and /or other pertinent instructions. Ingredients used to make finished OIM products are identified and measured before adding to the blend.

c. All OIMs can be traced by a lot number or production code that identifies each production batch.

E. Process Verification for Liquid Organic Input Material

1. Determine if the firm manufactures liquid OIMs with a total nitrogen (N) guaranteed analysis greater than 3%.

• If the firm manufactures > 3% N liquid OIM, obtain a sample of the finished product and all nitrogen-containing ingredients for lab analysis.

• Samples must be secured, identified, and accompanied by a copy of the CDFA Fertilizer Sample Data Sheet.

2. Conduct a mass balance analysis using a table provided in the OIM inspection audit using the lab analysis sample results for the percentage of Nitrogen, as well as the total units from the witness product’s production record, and the ingredient (or finished product) names.

a. Explain the reason(s) for the percentage variance of the mass balance analysis and whether it merits re-inspection.

b. Specify how the Nitrogen values were obtained.

F. Summary of Findings

1. Write a summary of findings that provides a general overview of the inspection and a list of action items for the firm to address.

• Follow the itemized summary of findings template guideline within the OIM Inspection Audit (or OIM Follow-Up Inspection Audit) (Attachment 2) and ensure that all information is included.

2. Sign the OIM audit and obtain the signature of the firm’s designated agent.

V. Protocol – Post-Inspection & Report Preparation

1. Contact CDFA immediately with any urgent concerns of firm noncompliance.

2. Submit all samples for laboratory analysis within 24 hours by an expedited, yet reasonably affordable carrier, to CDFA’s laboratory (except for samples taken in India*) at the following address:

Center for Analytical Chemistry Attention: Regulatory Analysis 3292 Meadowview Road Sacramento, CA 95832

*Samples taken in India may be analyzed at a laboratory located within India if they cannot be shipped to the Center for Analytical Chemistry.

3. Prepare all records and reports of inspections in accordance with CDFA processes and procedures.

4. If an inspection does not fulfill the audit requirements or an incomplete report is submitted (i.e., not completing the balance-in/balance-out analysis table when required, not obtaining requested samples for lab analysis, not including required documentation, and/or not collecting required signatures), payment for an inspection may be withheld by CDFA until corrected and fulfilled.

5. The completed OIM Inspection Audit report and all electronic documents should be emailed to the third-party contractor’s lead facilitator who will combine the documents within a PDF portfolio.

o Finished reports should be emailed to the CDFA registration staff who initially emailed the Organic Input Material Pre-Inspection Summary.