25-0004_Attachment_2,_CDFA_OIM_Inspection_Audit.pdf

ATTACHMENT 2

State of California

CONFIDENTIAL Department of Food and Agriculture Fertilizing Materials Inspection Program

Rev. 11/2021 Form: OIM-0009 Approved: NY Date: 11.04.21

ORGANIC INPUT MATERIAL (OIM)

INSPECTION AUDIT

Date of Inspection:

Date of Previous Inspection:

Inspector(s):

Sample Number(s) & Product/Ingredient Name(s):

Inspected Firm Name (OIM Guarantor)

Firm ID#

Inspection Location & Firm Name (if different from guarantor)

Address

Address

City, State & Zip Code

City, State & Zip Code

Telephone / Email

Telephone / Email

Authorized Company Representative & Title:

Does the firm manufacture, distribute or warehouse both organic input material & conventional fertilizing material?

(circle one)

Y or N

Name of Product Observed During Production Process:

(If a product is not being manufactured, state the reason)

Ingredients Used for Observed Production Process:

Y N n/a Circle the appropriate answer in the left column to indicate the respective conditions or practices observed at this facility. Provide a narrative after each question to indicate specific observations, follow-up actions or recommendations.

I) CORRECTIVE COMPLIANCE

A) COMPLIANCE ISSUES FROM PREVIOUS INSPECTION

Y N n/a 1. Were there compliance issues that required correction at the previous Organic Input Material (OIM) inspection?

Identify the compliance issues.

Y N n/a 2. Firm corrected these compliance issues since the prior inspection. If the answer is “no,” provide an explanation.

II) LICENSE, REGISTRATION & LABELING

A) FERTILIZING MATERIALS LICENSE

Y N 1. Firm possesses a valid California fertilizing materials license.

CONFIDENTIAL

Y N 2. Firm is up-to-date with mill assessments. List any delinquent mill assessments.

Y N 3. Firm is up-to-date with tonnage reporting. List any delinquent tonnage reports.

Y N 4. Firm possesses a facility map. Inspector: Obtain a facility map.

B) PRODUCT REGISTRATION

Y N 1. Have any organic material review organizations issued a noncompliance notice or denied approval for organic food and crop production within the last three years? Circle “yes” if the firm has had a denial or noncompliance notice, then note the name of the material review organization, the product(s) involved, the date of notification, and the issue(s) resulting in denial or noncompliance.

Y N 2. All of the firm’s OIMs are registered with CDFA. List any unregistered OIMs.

3. The approximate number of finished Organic Input Materials manufactured or guaranteed by this firm:

4. Identify the finished OIMs manufactured at this location:

C) LABELING

Y N 1. A label is affixed to, or accompanies, all OIMs being distributed and all OIM containers in inventory possess a label. (Not including empty containers & packages.)

Y N n/a 2. Silos/bins/bulk tanks are clearly labeled and designated for specific commodities.

Y N n/a 3. OIM label(s) provided during the inspection match the registered labels on file with CDFA.

Inspector: Obtain actual production label(s) (not copies) for all registered OIMs produced at this inspection location, as well as the stamped, approved label(s) from CDFA. Identify any OIM labels that do not match the label registered with CDFA and describe the differences. For differing labels, instruct the firm to complete a OIM-0031 Registration Update Form that can be found at http://www.cdfa.ca.gov/is/ffldrs/fertilizer_OIM.html. The OIM -0031 form includes submission instructions.

4. List person(s) responsible for creating product labels:

http://www.cdfa.ca.gov/is/ffldrs/fertilizer_OIM.html

III) ORGANIC INPUT MATERIAL (OIM) INGREDIENTS

Y N n/a 1. Each incoming ingredient of OIMs is accompanied by documentation to verify its origin and quantity (invoice, bill of lading, purchase order, delivery ticket, or weight certificate). Inspector: Obtain proof of purchase documentation for each ingredient used in OIM production. Identify the ingredient names and the suppliers from the documentation.

Y N n/a 2. OIM ingredients are stored in original containers (not applicable to bulk material) and lot integrity is preserved.

Y N n/a 3. OIM ingredients are received, handled, and stored in a manner to prevent comingling or contamination. Verify that OIM ingredients appear to be free from visible signs of cross-contamination from adulterants.

Y N 4. Do any OIMs contain binders, wetting agents (or surfactants), anti-oxidants, dust suppressants, anti-caking or flow agents, defoamers, odor control, or similar ingredients? If yes, please list the additives.

Y N n/a 5. OIMs claiming to contain organisms, enzymes and other biologically active by-products of organisms, state the name, species, viable units, expiration date, and storage conditions on the label.

IV) CLEANOUT PROCEDURES & PROCESS PARAMETERS

A) CLEANOUT PROCEDURES

Y N n/a 1. Clean out procedures are in place to prevent adulteration of OIM (sequencing, captured dilute solutions, flushing, and physical). Inspector: Obtain cleanout procedure documentation, if applicable. Describe the cleanout procedure if the firm does not have it in writing.

Y N n/a 2. Equipment cleanout is verified and documented. Inspector: Obtain a copy of cleanout log, if applicable.

Y N n/a 3. Trucks are inspected for possible cross-contamination prior to bulk loading.

n/a 4. Identify cleaning material and describe any removal process (e.g. triple water rinse, air dry, compressed air, etc.)

B) PROCESS PARAMETERS

1. Critical: Identify the product witnessed during production AND describe the observed manufacturing process.

Y N n/a 2. Does the OIM production process require certain specialized parameters to comply with NOP?

(i.e. compost time/temp (131˚F - 170˚F)/turning documentation, temperature monitoring documentation for processed manure & pellet mills, fish fertilizer ≥ 3.5 pH adjustment, etc.) Inspector: Obtain documentation and verify compliance, if applicable. Describe additional process parameters:

Y N n/a 3. For compost, vermicompost, compost teas, liquid fish products, and microbial products, pathogen analysis reports are within tolerance. (< 1,000 mpn / g fecal coliform and < 0.75 mpn / g Salmonella [also expressed as < 3 mpn / 4 g].) Inspector: If applicable, obtain the most recent pathogen analysis report and ensure that the report has analysis for BOTH fecal coliform and Salmonella. E. coli analysis is not an acceptable alternative to fecal coliform analysis.

V) PRODUCTION

Inspector: Obtain a sample of finished product from witnessed production for lab analysis.

A) PRODUCTION

Y N n/a 1. Production records are maintained to verify product, sequence and quantity produced.

Inspector: Obtain a complete and traceable history of the witnessed production.

Y N n/a 2. OIM products are manufactured using either a master formula or batch sheet that include the appropriate weight or volume of each ingredient, as well as mixing steps, times, and/or other pertinent instructions.

Ingredients used to make finished OIMs are identified and measured before adding to the blend.

Y N n/a 3. Have any of the product formulations or ingredient suppliers changed since the products were last registered?

Identify any formulation and/or supplier changes and direct the firm complete and submit an OIM-0031 Registration Update Form and a revised OIM-0013 Formula Sheet. The OIM-0031 form includes submission instructions. Both forms can be found here: http://www.cdfa.ca.gov/is/ffldrs/fertilizer_OIM.html.

Y N n/a 4. All OIMs can be traced by a lot number or production code that identifies each production batch.

http://www.cdfa.ca.gov/is/ffldrs/fertilizer_OIM.html

INSPECTOR: Delete the VII) PROCESS VERIFICATION FOR LIQUID ORGANIC INPUT MATERIAL section if the firm does not produce a liquid OIM with a total nitrogen guaranteed analysis greater than 3%.

VII) PROCESS VERIFICATION FOR LIQUID ORGANIC INPUT MATERIAL

1. Conduct a mass balance analysis of a finished liquid OIM with a total nitrogen guaranteed analysis greater than 3%. Refer to the inspector instructions below.

INSPECTOR: FOR LIQUID OIMs THAT CONTAIN > 3% NITROGEN, OBTAIN SAMPLES FOR LAB ANALYSIS

OF FINISHED PRODUCT AND ALL NITROGEN-CONTAINING INGREDIENTS.

Lab Analysis Calculation Template — to be completed after receipt of CDFA lab analysis INSPECTOR INSTRUCTIONS: Double-click on the table below to activate the table for editing. Enter the name(s) of the applicable nitrogen-containing ingredients as well as the finished product name. Enter the Total Units. Insert the % of N from CDFA lab analysis results. Do NOT manually enter data in the “Total weight of N” and “Totals” columns as it will invalidate the calculation formulas. Similarly, please refrain from adding or deleting rows unless there are additional sources of nitrogen.

Ingredient or Product Name Total Units (lbs) % of N Total weight of N

(lbs) Ingredients:

Insert Ingredient Name & Grade 0 0 0.00 Insert Ingredient Name & Grade 0 0 0.00 Insert Ingredient Name & Grade 0 0 0.00 Insert Ingredient Name & Grade 0 0 0.00

Overall Balance-In (Total N from Ingredients) 0.00

Finished Product:

Insert Final Product Name & Grade 0 0 0.00

Totals:

Overall balance-in for nitrogen (in lbs) 0.00 Overall balance-out for nitrogen (in lbs) 0.00 Actual Variance (in lbs) 0.00 Percentage Variance #DIV/0!

A NEGATIVE “Percentage Variance” may verify compliance.

2. Explain the reason(s) for the percentage variance above and whether it merits re-inspection.

3. Explain how the Nitrogen values included in the mass balance were obtained. (e.g.From CDFA lab analysis?

Third-party lab analysis? From the guaranteed analysis on the label? From an amount specified on an invoice?

Or some other explanation?)

SUMMARY OF FINDINGS:

INSPECTOR TEMPLATE GUIDELINE (Please delete this template guideline once the Summary of Findings is compiled.) If you provided a detailed narrative in the questions above, you may “cut & paste” the information within the applicable criteria below.

Paragraph 1

- Insert statement of license status.

- Insert statement of mill assessment status.

- Insert statement of tonnage report status.

- Identify any compliance issues that required correction from the previous OIM inspection (if applicable) and state whether or not they were corrected.

Paragraph 2

- Identify registered Organic Input Materials and any unregistered Organic Input Materials.

- Identify any inconsistencies between the labels provided by the firm and the stamped, approved CDFA label(s).

- Identify any points of interest about the products (i.e. “The firm stated that they no longer intend to produce Product XYZ.”)

Paragraph 3

- Identify the product witnessed during production.

- Explain, in detail, the production process you witnessed.

Paragraph 4 – Only For Firms Producing A Liquid OIM Over 3% Nitrogen

- Note the percentage variance of the mass balance and whether it is deemed acceptable or if it merits re-inspection.

- Explain how the Nitrogen values included in the mass balance were obtained.

(CDFA lab analysis? Third-party lab analysis? From the guaranteed analysis on the label? From an amount specified on an invoice? Or some other explanation?)

Paragraph 5

- Note all action items with bullet points Example: CDFA requires the firm to complete the following action items:

• Renew the delinquent license for the Miami, Florida location

• Submit an updated pathogen analysis report for Product XYZ

Add a statement of consequence “Failure to comply may result in product quarantine, cancellation of product registration, and/or administrative penalties.

________________________________ X___________________________ Inspector / Investigator (Name & Agency) Inspector / Investigator Signature

Date Signed

________________________________ X___________________________ Authorized Company Representative (Name & Title) Authorized Company Representative Signature

Date Signed

All original, confidential inspection documentation must be submitted to CDFA.

Any copies must be destroyed in accordance with California state laws, regulations, or protocols.