Summary of Proposed Modifications to OCal Comparable-to-Organic Program Regulations
September 10, 2020
by Gianna Geil, Law Student at UC Hastings and Intern at Law Offices of Omar Figueroa
On August 31, 2020, the California Department of Food & Agriculture (CDFA) issued proposed modifications to the OCal Program regulations promulgated previously this year. As discussed in our previous blogpost, the OCal Program is a statewide certification program that will establish and enforce cannabis standards comparable to the National Organic Program (NOP), a federal regulatory program developing and enforcing standards for organically-produced agricultural products. This blog post will cover the modifications proposed for each of the eight Articles.
Article 1. Definitions
Two modifications were made to the definitions set out in § 10000. First, the definition for “annual seedling” was eliminated. This change was made in response to a comment during the 45-day comment period noting the separate definition for “annual seedlings” created confusion because annual seedlings are already included in the definition of “planting stock.” Second, the definition for “responsibly connected” was added after a comment requested this term be defined as it is in the NOP regulations. The definition states that responsibly connected “means any person who is a partner, officer, director, holder, manager, or owner of 10 percent or more of the voting stock of an applicant or a recipient of certification, accreditation, or registration.” The addition of this phrase has implications for compliance procedures discussed below.
Various modifications were also made to the guideline documents incorporated by reference in § 10001. CDFA created these guideline documents, comparable to NOP guidance documents, to assist entities with the implementation of and compliance with the OCal regulations.
First, it was clarified that laboratories should be able to test for analytes listed on OCal 2611-1, the required pesticide tests in BCC regulations, and any additional analytes required by the certifying agent. The previous wording left it unclear exactly what analytes laboratories had to test for. Second, the amendments expanded documentation maintenance requirements for certifiers to bring the regulations in line with NOP guidance. Certifiers must maintain documents supporting their determination regarding whether a product is allowed or prohibited for use in OCal production, including products approved based on prior determinations by another certifier, and now also prior determinations by a Material Review Organization or the Environmental Protection Agency. Third, guidance on vermicomposting of animal materials, which is in NOP guidance and was inadvertently omitted from the OCal guidance documents, was added.
Article 2. Applicability
§ 10101, outlining what operations must be certified, was amended to remove the phrase “privately certified” since it is not used elsewhere or defined in the regulations. The regulation now clarifies that a cultivation or distribution operation, or specified portion thereof, shall be deemed certified from the date its certifying agent receives registration until the next certification anniversary date so long as the certifier demonstrates the operations compliance with the regulations.
Article 3. OCal Cultivation and Distribution Requirements
The title of § 10201 was altered from “OCal cultivation and distribution system plans” to “OCal system plans” because the latter phrase is what is used within the section and throughout the regulations.
Article 4. Labels, Labeling, and Market Info
Three changes were made to Article 4. First, § 10300(c) was modified to clarify that OCal cannabis or cannabis product packages may display, on the packaging, labeling, or marketing information concerning the product, one or more of the following: the term OCal to modify the product name, the OCal seal, or the seal or mark of the registered certifying agent which certified the operation that produced the finished product so long as the seal or mark is not displayed more prominently than the OCal seal. There was some confusion as to whether all three must be displayed or any single one.
Second, § 10300(d), which required that the cultivator and cultivator’s registered certifying agent be identified on the package, was amended to bring the regulation more in line with NOP. This amendment specified that it is the cultivator or distributor, and their registered certifying agent, who handled the finished product that must be identified on the packaging.
Third, a new provision, § 10300(e), was included requiring that OCal cannabis be identified in the ingredient statement to indicate that the cannabis was OCal produced. This brings the regulations in line with NOP.
Article 5. Accreditation and Registration of Certifying Agents
Aside from minor changes in language to clarify the regulations, there were two substantive changes of note in this Article. First, § 10401(a)(7) on requirements for accreditation was amended to say that the certifying agent’s staff may conduct the annual internal program review, in addition to outside auditors or consultants.This amendment provides more flexibility to certifying agents and is consistent with NOP.
Second, an alteration was made to the requirements for renewal registration in § 10410(d). Whereas the previous regulation required certifying agents to submit an inspection report and copy of the OCal system plan (OSP) for each cannabis operation granted certification during the previous year, the amendment struck the requirement of submitting the OSP. This change was based on a comment noting the inefficiency and duplicative nature of the requirement because the OSP must be made available upon request per the regulations.
Article 6. Certification of Operations.
Two changes were made to § 10503 regarding on-site inspections. First, the language was altered to clarify that on-site inspections must include all of an operation’s units, facilities, or sites that are intended for OCal cannabis production. Second, subsection (a)(3) was stricken, which allowed inspectors to note and communicate to the certifier any exceptions to the conservation requirement such as extreme climactic conditions, or damage to the ecosystem beyond the control of the operation. As this subsection was not comparable to NOP, and is in conflict with other sections of the regulations requiring cultivators to maintain or improve the soil condition and minimize soil erosion, it was stricken.
Article 7. Fees
To bring the regulations in line with NOP, § 10602, which was inadvertently omitted, was added to outline the expectations and requirements for fees charged by registered certifying agents. Fees must be reasonable and applicants may only be charged for those fees filed with the department. If the certifying agent requires applicants to pay a nonrefundable fee at the time of application, this must be explained in the fee schedule submitted to the department. Additionally, to provide more transparency to the process, certifying agents must provide applicants with estimates of the total cost of certification and annual cost of updating certification, as well as provide a copy of fee schedules to any person inquiring about the application process.
§ 10603 was amended to clarify that fees paid to the department must comport with sections 10600 or 106001 and pursuant to any directions on the bill or notice. This clarification was required due to the addition of § 10602.
Article 8 Compliance
Various amendments were made to Article 8. First, two changes were made to the department’s authority to issue administrative fines for violations. § 10701(e)(2) was amended to clarify that the department may issue a fine up to $20,000 per violation along with a Notice of Proposed Suspension or Revocation, a Suspension, a Revocation, or in response to a willful violation, except in the case of a labeling violation. There was concern that the previous language, simply stating the department could fine a certified operation up to $20,000 per violation, would allow the department to issue fines at any point for any noncompliance. Second, § 10701(e)(3) allowing the department to fine a registered certifying agent up to $25K per violation, was stricken because the fine amount specified in 10701(e)(2) applies to both certified operations and registered certifying agents already.
Second, two important changes were made to § 10703 on non-compliance procedures for certified operations. First, mediation is now included as an option for resolving non-compliance. The option of mediation was inadvertently left out of the regulations. Second, whereas the previous iteration of the regulations stated certified operations whose certification was revoked would be ineligible for a period of 5 years after the effective date of the revocation, the amendments now state that persons responsibly connected with the operation will be similarly ineligible.
Third, § 10707 was amended to clarify that all notices, not simply notices of adverse actions, may be appealed.
Fourth, § 10711(j), requiring the certifying agent to promptly report to the department if test results indicate a specific product contains pesticide residues or environmental contaminants that exceed the FDA’s or EPA’s regulatory tolerances, was stricken because there are no FDA, EPA or Bureau tolerance or action levels for cannabis to indicate contamination.
Public Comment
All public comments on these modified regulations must be received by 11:59 pm on September 15, 2020. For information on making effective comments see the CDFA handout here.
To submit a comment by email, send the comment to CDFA.CalCannabis_Ocal@cdfa.ca.gov with the email subject line “Comments on Ocal Regulations.”
To submit a comment by mail, send the comment to the following address:
California Department of Food and Agriculture
Attn: Kristi Armstrong
CalCannabis Cultivation Licensing
Proposed OCal Regulations
P.O. Box 942871,
Sacramento, CA 94271
This information is provided as a public educational service and is not intended as legal advice. For more information about the OCal regulations, please contact the Law Offices of Omar Figueroa at (707) 829-0215 or info@omarfigueroa.com to schedule a confidential legal consultation.