Regulatory bulletin: Changes to California’s Department of Pesticide Regulation Notice of Decision (NOD) process
USA: Beginning May 1, California’s Department of Pesticide Regulation (DPR, the Department) will be implementing changes to its ‘Notice of Proposed and Final Decisions and Public Reports’ process. Currently, to comply with the mandates of the California Environmental Quality Act (CEQA), DPR issues weekly reports that are posted for a 30-day public comment period. These reports are provided to notify the public of decisions by DPR regarding the proposed registration of pesticide products following the evaluation of compliance to California pesticide laws and regulations. From May, CDPR pesticide Notices of Decision (NODs) justifying proposed registrations and amendments will link to separate, more comprehensive environmental and human health impact reports. The new documentation requirements may significantly lengthen the review process.
TSG's Regulatory Consultant Alex Camacho outlines the new process, the anticipated impacts to registrants, as well as the key to a successful and smooth California registration process.
Why is this change happening?
In 2014, a lawsuit was filed against California’s DPR by the Pesticide Action Network of North America (PANNA). The lawsuit alleged that DPR has violated CEQA by approving amendments to product labels without sufficient environmental review. After considering the presented evidence, the courts found that the ‘Notice of Proposed Decision to Register’ document was deficient in meeting the requirements of CEQA in two ways:
- Discussion of available alternatives and potential cumulative impacts; and
- Documentation making transparent the DPR examination process that allowed for the conclusion that no significant effects are posed by the product to: human heath; flora (plants); fauna (fish and wildlife); water; and, air (all collectively referred to as the ‘CEQA checklist’).
The new process
The revised ‘Notice of Proposed Decision to Register’ document will now address all CEQA areas listed above and will include detailed public reports for each submission. These public reports will be hyperlinked for each submission and will be associated with the DPR Track ID#, which is the assigned submission number currently in use by DPR with which most registrants are familiar. Affected submission types are nearly all-encompassing and include: section 3 amendments, new registrations, and new active ingredients; master label registrations; California-only registrations, including 24c’s; and Section 18 registrations.
Each ‘Notice of Proposed Decision to Register’ will now include the following six key elements:
- Description of the project
- Overview of DPR’s Pesticide Registration Program & Scientific Evaluation process
- Environmental and human health factors examined (i.e. the “CEQA Checklist” described above)
- Discussion of feasible alternatives and mitigation;
- Existing environmental conditions and cumulative impacts
- Conclusion (i.e. a description of the action and a detailed summary of environmental and human health factors examined)
Anticipated impacts to registrants
The revised NOD process goes into effect May 1, 2019 for all registrants and is inclusive of any submission in the DPR system as of May 1, irrespective of the review queue placement. DPR has indicated that additional routing to the scientific evaluation stations may be needed, even for products that have completed their review process and would have otherwise been posted through the current process. However, this is anticipated only when items in the CEQA checklist cannot be addressed by the standard routing associated with the submission.
Other new potential impacts include:
- Container labels will be posted as part of the DPR NOD report
- This new process will lengthen the review procedure, although, at this time, DPR is not able to estimate how much additional time will be required and it will vary from submission to submission. Additional staff, with technical writing expertise, are actively being recruited and hired by the Department to address these new changes.
- DPR has also not indicated whether the additional support needed for this process will impact (i.e. increase) the current cost of a product registration (USD1,150.00).
- DPR has reassured the registered community that the change to the NOD process should not adversely impact the progress being made with the electronic submission programming efforts
How TSG can be of service to California registrants
TSG Consulting has strong relationships with DPR staff members that will be impacted by this change. We also have a deep understanding of the complexities DPR staffers will have to navigate through beginning on May 1. Key to a successful and smooth California registration process will be to anticipate the needs of DPR staff at the time of submission rather than after submission has occurred. In some instances, it will even make sense to proactively supplement submission packages currently under DPR review.
To learn more about these proactive measures to reduce the impact of this new process, please contact our experts at TSG Consulting. We can be reached at [email protected], +1 202 828 8990, or via the form opposite.