Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell and Lisa R. Burchi

On December 28, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-26 changing its Notice of Decision (NOD) and public report documentation for proposed registration decisions to ensure continued compliance with its certified regulatory program obligations under the California Environmental Quality Act (CEQA).  The new changes to the NODs and public report documentation will be effective May 1, 2019.

These changes are as a result of a 2014 lawsuit brought by Pesticide Action Network North America (PANNA), et al. challenging DPR’s acceptance of label amendments for two previously registered dinotefuran pesticide products.  The First District Court of Appeal held that DPR’s NODs and public reports supporting the dinoteferan registration actions were deficient because DPR could not demonstrate that it properly considered certain factors specified in CEQA.  In essence, the court concluded that certain CEQA requirements that DPR construed as procedural in nature were actually substantive standards that DPR must meet and adequately document in its administrative record.  Specifically, the court found that DPR failed to include a checklist or other documentation with meaningful analysis explaining how DPR reached its conclusion that the approval of the proposed label changes would not cause a significant adverse impact to human health, flora, fauna, water, and air.”  The court also found DPR’s discussion of alternatives and cumulative impacts inadequate.  Information about that case is available in our blog item California Court of Appeal Reverses Trial Court Decision Denying PANNA’s Petition Challenging Approval by DPR of Pesticides Containing Dinotefuran.

Background

CEQA is intended to ensure projects permitted by public agencies consider the long-term protection of the environment.  DPR states that CEQA “requires state and local agencies to develop an environmental impact report (EIR) for any proposed or approved project that may have a significant effect on the environment (including human health) or a negative declaration if there is substantial evidence of no significant impacts.”  EIRs provide public agencies and the public “with detailed information about a proposed project’s significant effects on the environment, describe ways these effects can be minimized, and indicate alternatives to the proposed project.”  CEQA and its implementing regulations set forth in Title 3, California Code of Regulations (3 Cal. Code Regs.) Sections 6254 and 6255, also require DPR to issue a weekly Notice of Proposed Decisions to Register Pesticide Products and Public Report, listing each proposed decision to register and amend pesticide products for a 30-day public comment period.  

Changes to the NOD and Public Report Documentation

To address concerns raised by the court and to protect its certified program status, on January 3, 2018, DPR issued California Notice 2018-01 (“Expanding Use of Pesticide Products Under Reevaluation”), providing that, effectively immediately, DPR “will not act upon an Application for Pesticide Registration or Application to Amend Pesticide Product if DPR determines the registration or acceptance would potentially ‘expand use’ … of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.”

With Notice 2018-26, DPR will change the documentation associated with its environmental analysis in the NODs and public reports.  According to Notice 2018-26, the revised NODs and public reports will address the following areas for each pesticide product noticed for registration:

  • Discussion of DPR’s certified program under CEQA;
  • Relevant DPR regulations for the proposed decision and public report;
  • Detailed description of the project;
  • Overview of the registration program, scientific evaluation process, and continuous evaluation;
  • Environmental and human health factors examined (i.e., checklist containing the following CEQA areas: human health, flora, fauna, water, and air);
  • Discussion of feasible alternatives and mitigation;
  • Discussion of existing environmental conditions and cumulative impacts; and
  • Conclusion explaining DPR’s analysis of potential significant adverse impacts to human health, flora, fauna, water, and air.

In addition, each public report will include the proposed label.  For label amendments, DPR will include both the proposed label and currently accepted label.

In summary, effective May 1, 2019, DPR “will no longer post new products and label amendments exiting the formal evaluation process as proposed to register for the 30-day public comment period until DPR completes a public report explaining why the new product or label amendment is not reasonably expected to cause a significant adverse impact to human health, flora, fauna, water, and air.”  New products and label amendments that exit the formal evaluation process prior to May 1, 2019, will be posted for the 30-day public comment period using the current NOD documentation.

The impact of these changes could be substantial from a timing and DPR workload perspective and, thus, of significant concern to registrants.  DPR has stated it is reviewing its internal processes and procedures and hiring additional staff to accommodate changes in workload as a result of the NOD and public report documentation changes.  This is based, in part, on the fact that if current evaluation reports are not available for each CEQA checklist area (i.e., human health, flora, fauna, water, and air), DPR staff may need to review prior evaluation reports, documentation in product files, U.S. Environmental Protection Agency (EPA) risk assessments, and other available information to develop the public report.  Moreover, DPR states that if it does not have adequate information to address each CEQA checklist area, the product may need to reenter DPR’s formal evaluation process.  All of these factors could significantly extend the amount of time DPR takes to review a new product or amendment, as it must now develop these public reports prior to proposing registration decisions with a 30-day public comment period, and that time could be even longer in cases where DPR determines it requires additional evaluation of the product and/or data necessary to complete such public reports.


 

By Timothy D. Backstrom and Lisa M. Campbell

On September 19, 2018, the California Department of Pesticide Regulation (DPR) proposed a regulation to designate chlorpyrifos as a toxic air contaminant (TAC).  DPR states that this proposal is being presented “after an extensive period of scientific and public review.”  The proposed rule is based on a final evaluation issued in July 2018, in which DPR’s Human Health Assessment (HHA) Branch determined that chlorpyrifos meets the quantitative criteria for designation as a TAC.  To make that determination, DPR utilized an inhalation reference concentration (RfC) based on new animal studies with chlorpyrifos that reported neurodevelopmental effects at exposure levels well below the threshold for acetylcholinesterase (AChE) inhibition.  More information on DPR’s final TAC evaluation is available in our blog item "California DPR Releases Final Toxic Air Contaminant Evaluation for Chlorpyrifos."  In August 2018, DPR posted the Scientific Review Panel on TAC’s findings on chlorpyrifos and the Director’s Proposed Determination Concerning Chlorpyrifos as a TAC.

DPR is providing a 45-day public comment period (until November 9, 2018) on the proposed regulation to list chlorpyrifos as a TAC.  Written comments may be submitted to .(JavaScript must be enabled to view this email address).  In addition, DPR is holding a hearing to receive oral comments on this issue on November 8, 2018, at 2:00 p.m. (PT) at the California Environmental Protection Agency headquarters, 1001 I Street, in Sacramento, California.  DPR states that it anticipates that the proposed regulation to list chlorpyrifos as a TAC will be effective in 2019.  Even though DPR is proposing to list chlorpyrifos as a TAC, DPR states that “possible mitigation measures to protect human health and the environment will be considered through a subsequent process involving consultation with other state and local agencies including the Office of Environmental Health Hazard Assessment (OEHHA) and the California Air Resources Board (CARB).”

Commentary

The U.S. Environmental Protection Agency (EPA) previously issued a determination that the default 10X safety factor for infants and children established by the Food Quality Protection Act (FQPA) should be retained for chlorpyrifos.  This determination was based primarily on epidemiology studies that purported to show adverse neurodevelopmental outcomes in humans at exposure levels below the threshold for AChE inhibition, but the methodology used in these epidemiology studies has been harshly criticized by the pesticide industry.  In contrast, the DPR TAC proposal is predicated on a determination that new animal studies with chlorpyrifos report neurodevelopmental effects below the threshold for AChE inhibition, and DPR views the epidemiology studies utilized by EPA to make its FQPA determination as providing corroboration for the animal data.  At this juncture, it is not clear how EPA will characterize the new animal data concerning chlorpyrifos.  In any case, questions are likely to remain concerning EPA’s use of data concerning chorpyrifos to establish the FQPA safety factor for other organophosphate (OP) pesticides.

More information on chlorpyrifos issues and California DPR regulations is available on our blog.


 

By Lisa M. Campbell and Timothy D. Backstrom

In July 2018, the California Environmental Protection Agency’s Department of Pesticide Regulation (DPR), Human Health Assessment (HHA) Branch, issued its final toxic air contaminant (TAC) evaluation of chlorpyrifos.  This final TAC evaluation updates the December 2017 draft evaluation of chlorpyrifos as a TAC for the Scientific Review Panel (SRP) which updated the August 2017 draft and was reviewed by the SRP on TACs, and incorporates certain changes based on SRP recommendations.  As part of their review of the December 2017 draft, the SRP recommended “additional and detailed review of developmental neurotoxicity studies, in particular recent in vivo animal studies as well as a more in depth analysis of human effects of chlorpyrifos” and “that DPR reevaluate the critical endpoints, the associated [(uncertainty factors (UF)], and the resulting [reference concentrations (RfC)] and [reference doses (RfD)] for each endpoint.”

DPR determines that a pesticide is a TAC for a non-cancer adverse effect if the projected air concentrations associated with use of the pesticide are more than one tenth of the inhalation RfC established based on animal toxicity and epidemiology data.  In the draft TAC evaluation for chlorpyrifos, DPR utilized the threshold for red blood cell acetylcholinesterase (AChE) inhibition in humans and a target margin of exposure (MOE) of 100, including a factor of 10 intended to account for potential neurodevelopmental effects below the threshold for RBC AChE inhibition.  In the final TAC evaluation for chlorpyrifos, DPR increased the MOE for AChE inhibition to 300, based on deficiencies in the human inhalation parameters used to model the threshold for AChE inhibition.

In addition, the final TAC evaluation establishes a new No Observed Effect Level (NOEL) for neurodevelopmental effects in animal studies with chlorpyrifos reported at exposure levels well below the threshold for AChE inhibition.  Based on this NOEL, DPR has derived a new inhalation RfC for neurodevelopmental effects, using a standard MOE of 100 consisting of 10X for interspecies sensitivity and 10X for intraspecies variability.  This new inhalation RfC based on neurodevelopmental effects in animal studies is about one-half the revised inhalation RfC based on the threshold for AChE inhibition.  Because the modeled spray drift air concentrations for chlorpyrifos are more than one tenth of this new inhalation RfC, DPR concludes “that chlorpyrifos meets the criteria to be listed as a TAC pursuant to the law of California.”

Commentary

In the final TAC evaluation for chlorpyrifos, DPR concluded that there is sufficient evidence from animal studies to establish a new NOEL for neurodevelopmental effects, which is well below the level that has been shown to cause AChE inhibition in the same animals.  Although the U.S. Environmental Protection Agency (EPA) has previously issued a determination that the default 10X safety factor for infants and children established by the Food Quality Protection Act (FQPA) should be retained for chlorpyrifos, this determination was based on epidemiology studies that purported to show adverse neurodevelopmental outcomes in humans at exposure levels below the threshold for AChE inhibition.  The methodology used in these epidemiology studies has been harshly criticized by the pesticide industry.  DPR views these epidemiology studies as providing corroboration, but the new DPR risk assessment is predicated instead on DPR’s view that animal studies with chlorpyrifos report neurodevelopmental effects below the threshold for AChE inhibition.  The DPR risk assessment based on these animal studies uses a standard MOE of 100.  How EPA may or may not view DPR’s conclusion is not known.  In light of the August 9, 2018, decision by the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) directing EPA to proceed with revocation of all tolerances and cancellation of all registrations for chlorpyrifos, the effect of the DPR conclusion on EPA actions is not clear.  Nevertheless, it is worth noting that, because the mechanism by which chlorpyrifos would cause such neurodevelopmental effects is unknown and is below the level that causes AChE inhibition, any presumption by EPA that other organophosphate (OP) pesticides may cause the same type of effects will likely be vigorously disputed by industry on scientific grounds.  

Please see our blog item Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos for more information on the Ninth Circuit’s August 9, 2018, decision.


 

By Lisa M. Campbell and Margaret R. Graham

On April 23, 2018, the California Department of Pesticide Regulation (DPR) circulated a presentation entitled “Top 10 Agricultural Pesticide Use Violations of 2017” that identifies the top ten agricultural most common pesticide use violations of 2017 in California.  The violations are listed from the least common (#10) to the most common (#1):

10.       Handler Training, regulated under Title 3 of the California Code of Regulations (C.C.R.) § 6724(b-e).  Examples of handler training violations listed in the presentation are:  not updating employee training on a new pesticide handled; and not training employees prior to them mixing, loading, or applying pesticides.

9.         Availability of Labeling, regulated under 3 C.C.R. § 6602.  Examples of labeling availability violations listed in the presentation are:  not having relevant Special Local Needs (SLN) labeling at the site when mixing, loading, or applying; and not having the labeling booklet on-site when mixing, loading, or applying.

8.         Handler Decontamination Facilities, regulated under 3 C.C.R. § 6734.  Examples of these types of violations listed in the presentation are:  a handler using a backpack sprayer and not carrying a pint of eyewash when the label requires eye protection; and handlers using hand sanitizer instead of soap and water.

7.         Service Container Labeling, regulated under 3 C.C.R. § 6678.  Examples of service container labeling violations listed in the presentation are:  not including the signal word on a service container label; and only putting the name of the pesticide on the service container.

6.         Hazard Communication for Fieldworkers, regulated under 3 C.C.R. § 6761.  Examples of these types of violations listed in the presentation are:  not completing the required fields on the displayed Pesticide Safety Information Series (PSIS) A-9 leaflet; and not providing Safety Data Sheets (SDS) for the pesticides listed on the pesticide use records.

5.         Annual Registration with County Agricultural Commissioner by Anyone Who Intends to Advertise, Solicit, or Operate as a Pest Control Business in California, regulated under California Food and Agriculture Code (FAC) § 11732.  An example of a violation is not registering with the county in which such a business intends to work prior to performing pest control activities.

4.         Application-Specific Information (ASI) for Fieldworkers, regulated under 3 C.C.R. § 6761.1.  Examples of violations listed in the presentation are:  not including the start and stop times, Restricted Entry Interval (REI), or active ingredient in the displayed information; and not displaying the ASI before fieldworkers work in a treated field.

3.         Emergency Medical Care Requirements, regulated under 3 C.C.R. § 6726.  Examples of violations listed in the presentation are:  not taking employees suspected of a pesticide illness to the doctor immediately; and not posting the name, address, and phone number of the medical facility at the worksite or in the work vehicle before employees begin handling pesticides.

2.         Personal Protective Equipment (PPE) Requirements, regulated under 3 C.C.R. § 6738.  Examples of violations listed in the presentation are:  storing PPE in the same place pesticides are stored; and not cleaning PPE and checking for wear after each use.

1.         Labeling and Permit Condition Compliance, regulated under FAC § 12973.  Examples of violations listed in the presentation are:  not following label-required buffer zone, set back distance, or vegetative buffer strip requirements; and applying a pesticide to a site or crop not listed on the labeling.

DPR states that it “recommends and encourages continuing education (CE) course sponsors [to] integrate this information into … future CE courses,” and asks for help “in promoting lawful pesticide use practices by encouraging [CE] attendees to review these agricultural pesticide use violations as they relate to their operations, to assure they are in compliance with federal and California pesticide use requirements.”


 

By Lisa R. Burchi and Lisa M. Campbell

On January 3, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-01:  Expanding Use of Pesticide Products Under Reevaluation.  Under Notice 2018-01, effective immediately, DPR will not act upon an Application for Pesticide Registration or an Application to Amend a Pesticide Product if it determines the registration or acceptance would potentially “expand use” of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.  

DPR states that it commences a reevaluation of an existing registered pesticide when it finds, based on an investigation of all reported episodes and information received, that a significant adverse impact to human health or the environment has occurred or is likely to occur.  DPR states that the policy set forth in Notice 2018-1 is needed for pesticides under reevaluation because until DPR reviews existing data for substances under reevaluation, determines whether additional data to satisfy reevaluation data requirements must be submitted, and then receives and assesses additional data applicable to the reevaluation that can mitigate the concern that prompted the initiation of the reevaluation, DPR “is not in a position to determine that an expanded use will not cause a ‘significant adverse environmental impact,’ as required under its certified regulatory program (3 CCR section 6254).”  Once the reevaluation process is completed, DPR states that it will then be in a position, in light of its reevaluation determination, to consider applications for product registration or amendment.

Scope of Notice 2018-1

DPR is currently reevaluating certain pesticide products containing the following active ingredients:

  • Chloropicrin;
  • Copper-based antifouling paints (copper oxide, copper hydroxide, and cuprous thiocyanate);
  • Cyfluthrin;
  • Diazinon; and
  • Nitroguanidine neonicotinoids (imidacloprid, thiamethoxam, clothianidin, and dinotefuran).

This notice applies to new pesticide products that include these active ingredients, including supplemental distributor registrations (subregistrations) and amendments to currently registered pesticide products, when “expanding use” of the active ingredient relevant to the concern that prompted the reevaluation.  

Specifically, DPR states in Notice 2018-1 that it interprets the following types of actions, related to a new or amended product containing the active ingredient under reevaluation, as examples of “expanding use”:

  • A proposed new pesticide product, including any Special Local Needs registration or Experimental Use Permit, with a label bearing uses or exposure scenarios relevant to the concern that prompted the reevaluation. This includes any product label that is identical or substantially similar to a currently registered product in California.
  • Amendment of a currently registered product to add or modify uses or exposure scenarios relevant to the concern that prompted the reevaluation, even if such use is already on other currently registered pesticide products in California. Examples of such changes include:
    • New or modified uses (e.g., new crops, pests, or use sites);
    • New or modified use patterns (e.g., adding aerial, aquatic, soil applications, or outdoor use);
    • Significant formulation changes (unless prompted by the reevaluation);
    • Increased application rates or total use amount allowed (e.g., acreage or frequency of application); and
    • Other label additions or changes that may increase pesticide exposure in a manner that is relevant to the basis for the reevaluation.

This notice does not preclude expanded use of a product if the expansion is not consistent with uses or exposure scenarios relevant to the concern that prompted the reevaluation.  As an example, DPR states that an application containing an active ingredient that is under reevaluation over concerns regarding exposure to wildlife would not be precluded under this notice as an expanded use is if the product is labeled solely for indoor use, with no potential wildlife exposure.

DPR also acknowledges that a pest management or public health need could arise during a reevaluation that would support the issuance of an Emergency Exemption request under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  In those cases, with regard to the potential applicability of Notice 2018-1, DPR states that it “will assess the request by relying on currently available information and risk mitigation strategies.”

Discussion

DPR’s reevaluation process can take years to complete, so not only are pending affected submissions for products containing the active ingredients at issue effectively frozen, but future submissions for active ingredients newly entering the reevaluation process could be halted potentially for lengthy periods of time, despite the fact that DPR may ultimately determine that any identified “expanded uses” do not cause a significant adverse environmental impact.  It is an initiative that many in industry are monitoring closely.

More information on other California DPR-related issues is available on our blog under key phrase California DPR.


 

By Lisa M. Campbell and Heather F. Collins, M.S.

On Friday, November 3, 2017, the California Department of Pesticide Regulation (DPR) issued guidance (California Notice 2017-13) that DPR indicates is intended to align DPR policy with the U.S. Environmental Protection Agency’s (EPA) guidance on secondary container labeling for pesticides.  DPR’s guidance states that secondary containers are used by the pesticide industry as part of the process of applying pesticides and “cannot be sold or distributed.”  The guidance further notes that secondary containers are “most commonly used in institutional settings for concentrated antimicrobials that are diluted prior to use or to hold pesticides filled from a larger container to be used and stored prior to application.” 

Registrants may elect to provide users with labels for secondary containers.  DPR’s new guidance states:  “Secondary container labels are not required to be submitted to U.S. EPA or DPR.”  Under the new DPR policy, however, effective immediately, if a registrant submits a secondary container label to DPR, “it must bear the same signal word as the concentrate label or no signal word.”  DPR states that it will accept a secondary container label with a lesser signal word, precautionary statements, and alternate directions for use for the diluted product only if acute toxicity data are submitted or are currently on file to support these lesser statements.

DPR’s new guidance also incorporates EPA guidance on what a secondary label should contain.  (EPA does not require secondary containers to be labeled, but notes that the applicator remains responsible for following the requirements on the pesticide product’s labeling, and complying with other relevant requirements in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other statutes.)  Although registrants are not required to submit secondary container labels to EPA for review, EPA recommends that the applicator identify the material in the secondary container in the event of a spill to ensure that adequate information regarding the pesticide can be obtained in case of a medical or environmental emergency.  EPA recommends that such labels include the following information:

  • Product name;
  • EPA registration number;
  • Name and percentage of active ingredient of the concentrated product or if known, the percentage of active ingredient in the end-use dilution;
  • If the product in the secondary container is diluted, it should be followed by the phrase:  “The product in this container is diluted as directed on the pesticide product label”;
  • The same signal word as the registered concentrate container label;
  • The same precautionary statements as the registered concentrate container label unless the registrant has acute toxicity data supporting lesser precautionary statements for the diluted product and alternate directions for the diluted product are indicated on the concentrate container label; and
  • The statement:  “Follow the directions for use on the pesticide label when applying this product.”

DPR states:  “If currently registered products have secondary container labels on file with DPR that do not meet the above criteria, registrants should submit revised labels to DPR as an amendment.”

Each submission must include:

  • California Application to Amend Pesticide Product (DPR-REG-035);
  • $25 application fee (payable to:  Cashier, Department of Pesticide Regulation);
  • A copy of the most current EPA stamp-accepted label;
  • Six copies of the concentrate container label; and
  • Six copies of the secondary container label.
    • If the precautionary statement on the secondary container label bears lesser precautionary statements, the submission must be accompanied by acute toxicity data or a reference to data on file with DPR.

As an alternative to submitting revised labels, registrants have the option of requesting that DPR rescind acceptance of the current stamp-accepted secondary container label previously submitted.  Registrants may submit their request in writing on company letterhead to their assigned Regulatory Scientist.  If a secondary container label is inconsistent with the DPR-approved label, DPR will consider the product misbranded, and DPR notes that misbranded products are subject to enforcement action.

Registrants that have previously submitted secondary labels to DPR should review the label in comparison to the DPR-approved concentrate container label and the requirements in this notice.  All inconsistencies must be corrected via amendment submission to DPR or by making a request that DPR rescind acceptance of the current stamp-accepted secondary label so that the product is not considered misbranded and therefore subject to enforcement action.  


 

By Lisa M. Campbell and Timothy D. Backstrom

On September 19, 2017, California’s Court of Appeal for the First Appellate District reversed a trial court decision denying a petition by the Pesticide Action Network North America (PANNA) challenging the approval by the California Department of Pesticide Regulation (DPR) of amended labeling for two previously registered pesticides containing the active ingredient dinotefuran, a neonicotinoid:  Dinotefuran 20SG, manufactured by Mistui Chemicals Agro, Inc.; and Venom Insecticide, manufactured by Valent U.S.A. Corporation.  PANNA’s petition alleged that DPR “violated the California Environmental Quality Act (CEQA) by approving the label amendments without sufficient environmental review.”  The amended labeling for these two neonicotinoid products added some new registered uses and also increased the allowable application rates for certain existing uses.

The court’s construction of CEQA was a critical element in its decision.  Since the DPR regulatory program has been certified pursuant to CEQA, the court agreed that DPR can utilize its standard program documents for pesticide registration actions in lieu of the documents typically prepared under CEQA.  The court disagreed, however, with DPR’s assertion that “its regulatory program ‘is exempt from the substantive portions of CEQA.’”  The court found the DPR’s record supporting the dinoteferan registration actions to be deficient because DPR could not demonstrate that it properly considered certain factors specified in CEQA.  In essence, the court concluded that certain CEQA requirements that DPR construed as procedural in nature were actually substantive standards that DPR must meet and adequately document in its administrative record.

The court’s analysis of the two registration approvals focused on the potential effect of these actions on honeybees.  The court found that the administrative record compiled by DPR did not demonstrate that DPR meaningfully addressed potential alternatives to the registration amendments, and that DPR must consider alternatives even when it makes a finding that approved changes would have no significant environmental impact.  The court also found that DPR did not demonstrate that it properly assessed the “baseline” existing conditions prior to approval of the amendments, or the cumulative effects of these existing conditions and the new actions on honeybees.  The court additionally found that DPR should have recirculated its decision for further comment because the explanation of its decision was inadequate to allow meaningful public comment.  The court stated that “in light of the Department’s pending neonicotinoid reevaluation, its initial public reports for Venom Insecticide and Dinotefuran 20SG were both so inadequate and conclusory that public comment on the draft was effectively meaningless.”  Based on all of these factors, the court remanded the matter to the trial court with instructions to direct DPR to rescind the two approvals.

Commentary

That the court focused the basis for its decision on its finding that DPR failed to compile a record adequate to show that it met the substantive standards for decision established by CEQA is of concern to many industry stakeholders.  The court stated it was “perplexed” by how DPR could determine that the label amendments to allow new uses and use rates would have no significant impact on honeybees, when DPR is still engaged in a reevaluation of the effect of all neonicotinoid pesticides on pollinators.  In particular, the court was not persuaded that DPR made any meaningful evaluation of cumulative impacts because DPR only observed in “conclusory fashion” that “the uses are already present on the labels of a number of currently registered neonicotinoid containing products.”  This finding is of significant concern to registrants and will be monitored closely. 

More information on neonicotinoids is available on our blog.


 

By Lisa M. Campbell and Lisa R. Burchi

On May, 24, 2017, the California Department of Pesticide Regulation (DPR) issued guidance regarding its Notice 2015-13 to applicants registering pesticide impregnated materials bearing pesticide claims to be sold and distributed into or within California, per Notice 2015-13, issued December 11, 2015.  Each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017

The guidance includes information on the registration requirements, as well as:

More details on the requirements are available in our blog items California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims and California DPR Extends Filing Date to Register Pesticide Impregnated Products.


 

By Lisa M. Campbell and Lisa R. Burchi

On February 22, 2017, the California Department of Pesticide Regulation (DPR) announced it was extending the filing date for applications to register products made from pesticide impregnated materials bearing pesticide claims from March 1, 2017, to July 1, 2017.  Specifically, each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017.  DPR’s California Notice 2015-13 issued on December 11, 2015, informed pesticide product registrants and stakeholders of DPR’s intention to register products made with pesticide impregnated materials and bearing pesticide claims. 

The February 22 notice also states the following in terms of the requirements:

  • Each company with products made from pesticide impregnated material and sold under their own company name into or within California is required to register the product(s) as a pesticide;
  • The product must bear a federally approved pesticide label; DPR will assign a separate California-only registration number for purposes of tracking sales and use of the products in California;
  • Each company will need to obtain at least one registration for each use category of product sold (e.g., the apparel use category includes wearable items such as jackets, shirts, hats, socks, pants, and shorts; the non-apparel use category includes non-wearable items such as bedding, tents, seat covers, chopping blocks, shower curtains, and mouse pads); and
  • If items are impregnated with different pesticides or different percentages of the same pesticide, separate registrations will be required.

The requirements set forth in this notice do not apply to products that satisfy the requirements to be a treated article, including the requirement that any claims be related to protection of the article/substance itself.  The notice applies instead to those pesticide impregnated materials that include pesticidal claims that are not limited to protection of the material.  More information on the December 2015 notice is available in our blog item California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims.


 

By Lisa M. Campbell and Lisa R. Burchi

The California Department of Pesticide Regulation (DPR) recently proposed a regulation that it states is intended to “(1) provide minimum statewide standards for all agricultural pesticide applications near public K-12 schools and child day care facilities; (2) provide an extra margin of safety in case of unintended drift or when other problems with applications occur (e.g., equipment failure causes an unintended release of pesticide, or an abrupt change in weather conditions); (3) increase communication between growers and schools/child day care facilities; and (4) provide information to assist schools and child day care facilities in preparing for and responding to pesticide emergencies.”

This proposal has been long anticipated, is far reaching, and of significant concern to many growers and registrants. 

In its Initial Statement of Reasons, DPR summarizes the proposed regulations, stating that they will: “require growers to notify public K-12 schools, child day care facilities (except family day care homes), and county agricultural commissioners when certain pesticide applications made for the production of an agricultural commodity near a schoolsite are planned in the coming year and also a few days prior to the applications.”  The proposed regulation also would prohibit at certain times certain pesticide applications near these schoolsites.  Specifically, the regulation is proposed to do the following:

  • Prohibit many pesticide applications for the production of an “agricultural commodity” within a quarter mile of schoolsites from Monday through Friday between 6:00 a.m. and 6:00 p.m.  “Schoolsites” are defined by Education Code section 17609(f) as: “‘any facility used as a child day care facility, as defined in Section 1596.750 of the Health and Safety Code, or for kindergarten, elementary, or secondary school purposes. The term includes the buildings or structures, playgrounds, athletic fields, vehicles, or any other area of property visited or used by pupils.”  ‘Schoolsite’ does not include any postsecondary educational facility attended by secondary pupils or private kindergarten, elementary, or secondary school facilities.”   DPR also proposed to exclude from the definition of schoolsite any family day care homes “because, unlike other schoolsites, the locations of these facilities are not publically available.”  DPR states it considered other distances but proposed the one-quarter mile radius based on several factors, including but not limited the fact that this restriction is similar to the restrictions on fumigant labels that prohibit closer applications around schools and other difficult to evacuate sites and based on an analysis of pesticide illnesses due to drift from agricultural applications. The proposed prohibition would apply to applications by aircraft, sprinkler chemigation equipment, air-blast sprayers, and fumigant applications. In addition, dust and/or powder pesticide applications would also be prohibited during this time unless applied as a dust or powder using field soil injection equipment.
  • Require California growers and pest control contractors to notify public K-12 schools and child day-care facilities and county agricultural commissioners (CAC) when certain pesticide applications are made within a quarter mile of these schools and facilities.

Under the proposed regulation, California growers would be required to provide two types of notifications to a school or child day-care facility:

An annual notification that lists all the pesticides expected to be used during the upcoming year. This must be provided to the school or child day care facility administrator by April 30 each year.  The notice must include, among other things:

  • The name of pesticide products (and the main active ingredient) to be used;

  • A map showing the location of the field to be treated;

  • Contact information for the grower/operator and the County Agricultural Commissioner; and

  • The web address for the National Pesticide Information Center where additional sources of information or facts on pesticides may be obtained.

An application-specific notification which must be provided to the school or child day-care facility 48 hours before each application is made.  This begins January 1, 2018, and must include, among other things:

  • Name of pesticide products (and the main active ingredient) to be used;
  • Specific location of the application and the number of acres to be treated; and
  • Earliest date and time of the application.

Comments on the proposed regulation are due by November 17, 2016.  DPR states that a final regulation is expected to become effective in September 2017.   
 
Many have concerns with the proposed regulation, which DPR has been discussing publicly for some time.  These concerns include what many believe are significant economic impacts to growers and others that they believe may not have been adequately considered and are not necessary for appropriate use of registered pesticides.  Registrants and others should review the proposal carefully.  


 
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