By Lisa M. Campbell and Timothy D. Backstrom
On August 14, 2019, the California Department of Pesticide Regulation (DPR) issued cancellation notices to thirteen California registrants of pesticide products containing chlorpyrifos, including Dow Agrosciences LLC (now Corteva). Each of these notices is referred to as an "Accusation," and each affected registrant has 15 days to request a hearing concerning the proposed cancellation. DPR's issuance of these notices followed a final decision by the U.S. Environmental Protection Agency (EPA) to deny an administrative petition to revoke the tolerances and cancel the U.S. registrations for chlorpyrifos. DPR states: "Despite the Trump administration's reversal of a decision to ban the pesticide at the federal level, California continues to move forward to protect public health, workers, and the environment." Although it is unusual for a State to act unilaterally to cancel a State registration for a pesticide that is still registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), FIFRA Section 24(a) provides that States may separately regulate Federally registered pesticides so long as they do not purport to authorize any sale or use that is otherwise prohibited under FIFRA.
The risk assessment that supports DPR's proposal to cancel chlorpyrifos products is based on five animal studies published in 2016, 2017, and 2018, that report neurotoxicity from chlorpyrifos at exposure levels that are considerably lower than the levels that cause acetylcholinesterase inhibition. Based on its evaluation these studies, DPR has concluded that developmental neurotoxicity is the critical endpoint for chlorpyrifos and has derived a point of departure for chlorpyrifos risk assessment. Based on this assessment, DPR previously concluded that chlorpyrifos should be designated as a Toxic Air Contaminant (TAC). DPR presented its TAC findings to California's Scientific Review Panel at a meeting on July 30, 2018, and the Panel subsequently concluded that the DPR assessment of the developmental neurotoxicity of chlorpyrifos was "based on sound scientific knowledge, and represents a balanced assessment of our current scientific understanding."
On the same day DPR issued its cancellation notices for chlorpyrifos, DPR also announced it has established an Alternatives to Chlorpyrifos Work Group with experts from "agriculture, California universities, environmental justice groups, farmworker health and safety organizations, and pesticide manufacturers…" DPR has asked this Work Group to develop short-term practical alternatives to chlorpyrifos, along with a five-year action plan. The Work Group is supposed to conclude its work by the spring of 2020. The budget for 2019-2020 approved by the California Legislature also includes $5 million in grant funding to develop sustainable alternatives to chlorpyrifos.
The DPR decision to cancel chlorpyrifos relies primarily on new animal studies that report that chlorpyrifos causes neurodevelopmental effects at levels that are well below those that inhibit cholinesterase. DPR refers in passing to the epidemiology studies for chlorpyrifos that EPA used to make its Food Quality Protection Act (FQPA) determination for all organophosphate (OP) pesticides, but these data were not used by DPR to derive its point of departure for chlorpyrifos risk assessment.
EPA scientists have not yet prepared a formal evaluation of the new animal studies for chlorpyrifos, but EPA's decision to deny the petition to revoke tolerances and cancel registrations for chlorpyrifos states that EPA intends to evaluate the new animal studies as part of its registration review deliberations for chlorpyrifos. The FIFRA registrations for chlorpyrifos may also be affected by pending judicial actions challenging EPA's decision to deny the petition to revoke the tolerances and cancel the registrations for chlorpyrifos. In this complicated environment, it will be important to monitor the registrants’ and industry’s response to DPR's cancellation actions, as well as their efforts on the pending Federal court litigation and EPA's registration review process for chlorpyrifos.
By Lisa M. Campbell, Timothy D. Backstrom, Lisa R. Burchi, and James V. Aidala
On August 7, 2019, EPA took long awaited action concerning the inclusion of Prop 65 warning statements for glyphosate on EPA registered pesticide labels, which will likely impact the broader ongoing debate over EPA approval of Prop 65 warnings on pesticide labels. EPA’s August 7, 2019, letter to glyphosate registrants states that EPA “will no longer approve labeling that includes the Proposition 65 warning statement for glyphosate-containing products.” EPA stated further that “[t]he warning statement must also be removed from all product labels where the only basis for the warning is glyphosate and from any materials considered labeling under FIFRA for those products.” Moreover, EPA unequivocally states that “pesticide products bearing the Proposition 65 warning statement due to the presence of glyphosate are misbranded” under FIFRA Section 2(q)(1)(A). Registrants with glyphosate products currently bearing Prop 65 warning language, where the exclusive basis for such warning is based on the presence of glyphosate, must submit draft amended labeling that removes this language by November 5, 2019.
By way of background, California’s Office of Environmental Health Hazard Assessment (OEHHA) listed glyphosate as a chemical known to the state of California to cause cancer on July 7, 2017. OEHHA’s listing of glyphosate as a substance under Prop 65 is based on the International Agency on the Research for Cancer (IARC) classifying it as “probably carcinogenic to humans.” EPA scientists subsequently completed an independent review of the available scientific data on the potential carcinogenicity of glyphosate and do not agree with the IARC classification. Additional information regarding glyphosate is available at B&C’s blog.
Also of note is a February 26, 2018, preliminary injunction issued by the U.S. District Court for the Eastern District Court of California, in response to a motion filed by a coalition including Monsanto, CropLife America, and several growers associations alleging that the IARC classification decision for glyphosate is contrary to the international scientific consensus, that the required Prop 65 warning would be misleading to the ordinary consumer, that compelling the manufacturers of glyphosate to provide such a warning would violate the First Amendment because the warning is not factual and uncontroversial, and that the applicable criteria for injunctive relief were met. The February 26, injunction precluded OEHHA from enforcing its Prop 65 warning requirements against glyphosate registrants that otherwise would have taken effect on July 7, 2018. The Court did not rule that glyphosate should be removed from the Prop 65 list as a chemical known to the State of California to cause cancer, but did state that products containing glyphosate would not be required to comply with the warning requirements. In issuing the preliminary injunction, the Court stated that the required warnings are “false and misleading” and that plaintiffs “have shown that they are likely to succeed on the merits of their First Amendment claim, are likely to suffer irreparable harm absent an injunction, and that the balance of equities and public interest favor an injunction, the court will grant plaintiffs’ request to enjoin [Prop 65]’s warning requirement for glyphosate.” More information on that case is available at B&C’s blog. That injunction has not been appealed and remains in place.
Although the glyphosate warning that EPA has refused to allow is based on OEHHA’s recent listing under Prop 65, Prop 65 warnings on pesticide labels generally have been a significant issue since 2016 when OEHHA issued revised regulations regarding the content and transmission of Prop 65 warnings. As a result of these revisions, many registrants sought to add Prop 65 warning requirements to pesticide labels to meet Prop 65 requirements, but many registrants have not been able to obtain EPA approval for such warnings, resulting in much controversy and discussion. More information regarding the changes to Prop 65 warning requirements also are available at B&C’s blog.
In its press release announcing its guidance to glyphosate registrants, EPA Administrator Andrew Wheeler states: “It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a cancer risk. We will not allow California’s flawed program to dictate federal policy.” EPA states that its “independent evaluation of available scientific data included a more extensive and relevant dataset than IARC considered during its evaluation of glyphosate, from which the agency concluded that glyphosate is ‘not likely to be carcinogenic to humans.’” Wheeler is further quoted as stating: “It is critical that federal regulatory agencies like EPA relay to consumers accurate, scientific based information about risks that pesticides may pose to them. EPA’s notification to glyphosate registrants is an important step to ensuring the information shared with the public on a federal pesticide label is correct and not misleading.”
OEHHA immediately released its own press release on August 13, 2019, in which it “objects to US EPA’s characterization of any warning concerning glyphosate’s carcinogenicity as a false claim.’” After reiterating OEHHA’s listing glyphosate based on the IARC determination, OEHHA states that EPA’s position “conflicts with the determination made by IARC” and that “it is disrespectful of the scientific process for US EPA to categorically dismiss any warnings based on IARC’s determinations as false.”
The Court’s February 26, 2018, preliminary injunction was considered a significant development both for glyphosate specifically and perhaps for Prop 65 warning requirements generally, especially considering the recent influx to EPA of label amendments seeking EPA approval of revised Prop 65 warning language to address OEHHA’s revised regulatory changes. EPA’s guidance is equally significant, as EPA has now rejected the inclusion of a Prop 65 warning that EPA believes is misleading on a federal pesticide product label.
FIFRA Section 24(b) expressly prohibits any State from requiring any label language for a registered pesticide product beyond the labeling approved by EPA, and EPA has now declined to approve pesticide labeling that includes the Prop 65 warning for glyphosate. In some instances, EPA has been willing as a courtesy to approve labeling changes requested by a State, but the glyphosate determination demonstrates that EPA will not accept any label revisions that conflict materially with its own determinations. Although glyphosate is a fairly complex and controversial case, it will be important for registrants to monitor the evolution of EPA’s standard for when it will or will not approve a Prop 65 warning on a federal label, since this issue has been the subject of considerable controversy over the past several years.
By Lisa M. Campbell and Lisa R. Burchi
On May 29, 2019, the California Department of Pesticide Regulation (DPR) released California Notice 2019-05: Changes to California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2019-05), which updates the guidance in California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2018-06).
Notice 2018-06, issued in January of 2018, provided to applicants for California registration of new agricultural use pesticides guidance specifically related to the requirement to submit at least one terrestrial field dissipation (TFD) study conducted under “California or similar environmental use conditions.” DPR states it is revising this guidance based on comments from the Western Plant Health Association. The updated guidance is summarized below.
Notice 2019-05 also extends the effective date to July 1, 2020; for applications submitted July 1, 2020, or later, DPR states it will consider a TFD study to have been conducted under “California or similar environmental use conditions” if the study was conducted within or outside of California in accordance with U.S. Environmental Protection Agency (EPA) study guidelines and under certain criteria, as provided below.
1. Timing: April 1 shall be the earliest study start date and September 30 shall be the latest start date. This timing ensures a potential leaching environment with respect to the amount of percolating water produced relative to evapotranspiration (ET).
- The study is conducted in a coarse-texture soil in accordance with the U.S. Department of Agriculture (USDA) soil textural classification (see Table 1). The minimum depth-weighted average sand content for representative samples taken across the test site should be no less than 68 percent as measured within the top 30 cm of soil. The allowable minimum soil sand content that is included in the average is 61 percent.
- The soils used for the study do not have a restrictive layer to the movement of water as indicated within the soil profile, such as a hardpan, compacted layer, or an abrupt change in texture.
- The maximum depth-weighted average organic matter content for representative samples taken across the test site should be no greater than 1.4 percent as measured within the top 30 cm of soil. The allowable maximum organic matter content that is included in the average is 1.6 percent.
- Studies shall be conducted on bare soil plots. Exceptions are possible for studies conducted in the presence of a crop or turf with sufficient justification.
3. Water Inputs:
- Water applications to the study site are sufficient to create levels of percolating water that reflect the potential amount lost from crop irrigations (i.e., 160 percent of ET). Approximately 60 percent of applied water is available for movement below the coring depth, which would equate to water applications of approximately 160 percent of ET. Therefore, a scheduled water input would approximate the cumulative daily ET since the previous water input multiplied by an excess demand factor of 1.6. For bare soil plots, ET can represent reference ET or, if preferred, soil evaporation when calculated using a scientifically defensible methodology. These water inputs supersede those in EPA’s guidance document for TFD studies.
- The initial water application to the study site occurs within one week of chemical application. Subsequent water applications shall be at seven-day intervals or less for the duration of the study.
- Water inputs from rain are subtracted from scheduled water input amounts.
DPR states that if a TFD study submitted to DPR to meet the statutory requirement of having been conducted under “California or similar environmental use conditions” does not meet one or more of the above criteria, the applicant may include in its submission a justification for any different criteria to avoid a determination that the study is unacceptable.
Table 1. USDA textural classes1 of soils acceptable for TFD studies
1Based on USDA particle-size classification.
By Lisa M. Campbell and Lisa R. Burchi
On May 28, 2019, the California Department of Pesticide Regulation (DPR) posted a new presentation identifying the top ten agricultural pesticide use violations of 2018. Its announcement states that “DPR suggests reviewing these common violations of pesticide laws and regulations to help ensure … compliance.” The presentation, “Top 10 Agricultural Pesticide Use Violations of 2018,” is available here. The violations are listed from the least common (number 10) to the most common (number 1):
10. Handler Training, regulated under Title 3 of the California Code of Regulations (C.C.R.) § 6724. Examples of handler training violations listed in the presentation are: not updating employee training before a new pesticide is handled; and not providing employees handler training before they work on or repair equipment previously used to apply pesticides.
9. Application-Specific Information (ASI) for Fieldworkers, regulated under 3 C.C.R. § 6761.1. Examples of violations listed in the presentation are: not including a specific description of the location of the ASI on the Pesticide Safety Information Series (PSIS) A-9 leaflet so that workers have unimpeded access; and not displaying the ASI before fieldworkers work in a treated field.
8. Hazard Communication for Fieldworkers, regulated under 3 C.C.R. § 6761. Examples of these types of violations listed in the presentation are: not retaining Safety Data Sheets (SDS) for the pesticides listed in the pesticide use records within the past two years; and not informing employees or the Farm Labor Contractor (FLC) of the location of the pesticide use records before the employees enter a treated field.
7. Handler Decontamination Facilities, regulated under 3 C.C.R. § 6734. Examples of these types of violations listed in the presentation are: not having an emergency eye flush station able to rinse the eye gently for 15 minutes at the mix and load site, when protective eyewear is required by the pesticide labeling; and handlers using hand sanitizer for decontamination instead of soap and water.
6. 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 booklets on-site when mixing, loading, or applying.
5. 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 not including the address of the company or person responsible for the container on the label.
4. 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 performing pest control activities in a county before registering with the County Agricultural Commissioner (CAC).
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 failure to post the handler emergency medical care information.
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 an employer not providing the proper PPE required by the labeling.
1. Labeling and Permit Conditions Compliance, regulated under FAC § 12973. Examples of violations listed in the presentation are: not following the pesticide storage requirements listed on the labeling; and applying a pesticide to a site or crop not listed on the labeling.
Additionally, DPR has created an informative presentation about the 2019 license renewal process to help spread awareness to those renewing this year (last names and business names starting with M-Z). DPR states that it encourages continuing education (CE) sponsors, CAC staff, and others to use the presentation to inform license and certificate holders renewing this year about DPR’s renewal process, CE requirements, important dates, and the benefits of renewing early. The 2019 Renewal Process presentation is available here.
By Lisa M. Campbell and Lisa R. Burchi
On May 8, 2019, the California Environmental Protection Agency (CalEPA) announced that the California Department of Pesticide Regulation (DPR) will be initiating cancellation proceedings of chlorpyrifos. In its press release, CalEPA states that the decision to commence cancellation proceedings “follows mounting evidence, including recent findings by the state’s independent Scientific Review Panel on Toxic Air Contaminants, that the pesticide causes serious health effects in children and other sensitive populations at lower levels of exposure than previously understood.”
DPR’s decision, following years of review in California of chlorpyrifos, is sure to garner significant controversy, comments, and, potentially, litigation.
Chlorpyrifos first entered the comprehensive risk assessment process after being designated by DPR with a “high” priority status in 2011, and some of the DPR documents supporting the current action were issued in 2011.
In December 2015, DPR released a draft risk assessment for public comment. Since the risk assessment identified potential human exposure to spray drift (via inhalation or deposition) as a concern, DPR entered chlorpyrifos in its formal evaluation process to determine the scientific evidence for listing it as a pesticide Toxic Air Contaminant (TAC) (CA Food & Agric. Code §§ 14021-14027).
DPR’s assessments were intended to evaluate chlorpyrifos as a pesticide TAC as defined in California regulations (Title 3, Section 6864). The determination of a pesticide TAC is based on whether the air concentrations, either measured or modeled, exceed the reference concentration (RfC) divided by ten. Under the applicable California statutory provisions, designation of an active ingredient as a TAC is based on an evaluation that assesses the following:
- The availability and quality of data on health effects;
- The potency, mode of action, and other relevant biological factors;
- An estimate of the levels of exposure that may cause or contribute to adverse health effects; and
- The range of risks to humans resulting from current or anticipated exposure (CA Food & Agric. Code § 14023(a)).
DPR published its draft revised report entitled "Evaluation of Chlorpyrifos as a Toxic Air Contaminant" in December 2017 and an addendum to that report in June 2018. DPR issued its final TAC evaluation in July 2018. The July 2018 evaluation concludes that “chlorpyrifos meets the criteria of TAC designation by using either the developmental neurotoxicity endpoint or the [acetylcholinesterase (AChE)] inhibition endpoint, even without the additional 10x uncertainty factor necessary to account for the fact that the developmental neurotoxicity effects occur at a lower level than AChE inhibition.”
DPR’s findings, public comments, and responses to those comments were reviewed by the Scientific Review Panel (SRP) on TACs. SRP’s findings on chlorpyrifos issued in August 2018 “unanimously concluded that the report, with the revisions requested by the Panel, is based on sound scientific knowledge, and represents a balanced assessment of our current scientific understanding.”
In April 2019, chlorpyrifos was listed in California as a TAC, which triggered a DPR requirement to “develop control measures to protect the health of farm workers and others living and working near where the pesticide is used.” In its press release announcing the cancellation proceedings, CalEPA states that “DPR has determined, in consultation with CDFA, the Office of Environmental Health Hazard Assessment (OEHHA), and the California Air Resources Board (CARB), that sufficient additional control measures are not feasible.”
DPR’s announcement is the beginning of what DPR estimates could be a two-year cancellation proceeding, although in reality the process may take even longer. Other actions proposed in conjunction with the cancellation proceeding include:
- DPR to consult with county agricultural commissioners and local air pollution control districts before filing for cancellation.
- DPR to support “aggressive” enforcement of existing restrictions on the use of chlorpyrifos, including a ban on aerial spraying, quarter-mile buffer zones, and limiting use to crop-pest combinations that lack alternatives.
- DPR and CDFA to convene a cross-sector working group to identify, evaluate, and recommend safer and more practical and sustainable alternative pest management solutions to chlorpyrifos.
- California Governor Gavin Newsom to propose $5.7 million in new budget funding “to support the transition to safer, more sustainable alternatives.
DPR’s action must also be viewed in conjunction with various federal and state reviews and resulting litigation regarding chlorpyrifos’ continued registration and use. The U.S. Environmental Protection Agency (EPA) for example, is conducting its own registration review of chlorpyrifos, and was ordered by the U.S. Court of Appeals for the Ninth Circuit to issue, within 90 days of the April 19, 2019, order, its final decision regarding the continued registration of chlorpyrifos.
Other states are also taking action to ban chlorpyrifos, notably Hawaii, which enacted legislation in 2018 to ban the use of chlorpyrifos in Hawaii by 2022; and New York, whose legislature approved bills in April 2019 to ban chlorpyrifos use in New York by 2021.
Stakeholders should review all these issues closely, as these unprecedented decisions are likely to provide multiple opportunities to comment or otherwise participate to ensure that regulatory requirements are indeed being met for cancellation.
More information concerning chlorpyrifos is available on our blog.
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.
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.
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.”
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 Lisa R. Burchi
On April 23, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced it is proposing to amend Article 6 of Title 27 of the California Code of Regulations (C.C.R.), Section 25603, specifically the safe harbor warning content for on product warnings for exposures to listed chemicals in pesticides. OEHHA states that this regulation is “intended to provide compliance assistance for businesses that cause pesticide exposures in order to reduce the potential for litigation concerning the sufficiency of warnings, while still allowing them to comply with other federal and state requirements for warnings provided on a label.” It is a part of the new Article 6 Clear and Reasonable Warnings regulations, which OEHHA adopted in August 2016 and which become effective on August 30, 2018. These new regulations include safe harbor warning methods and content for consumer product exposures (Sections 25602 and 25603) and occupational exposures (Section 25606) to listed chemicals. The Initial Statement of Reasons (ISOR) is available here and the proposed regulatory text is available here. The ISOR summarizes the proposed rulemaking:
- This proposed rulemaking would add a new subsection (d) to Section 25603, addressing safe harbor warning content for on product labels for consumer product and occupational exposures to listed chemicals from the use of pesticides where those labels are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and related California laws and regulations.
- This new subsection would further the “right-to-know” purposes of the statute and clarify the content of safe harbor warnings for exposures that can occur from the use of pesticide products, where those warnings are provided on a label that is regulated under FIFRA and certain California laws.
The issue that OEHHA intends this proposal to address stems from the fact that OEHHA’s revised warning requirements require the signal word “WARNING” but the U.S. Environmental Protection Agency (EPA) “historically has not approved labels containing the terms ‘caution,’ ‘warning,’ or ‘danger,’ unless the word is the same as the [EPA]-required signal word for that label.” Thus, OEHHA is proposing the following regulatory exception from the “WARNING” requirement:
- Notwithstanding subsection (a)(2) or (b)(2) [setting forth the content of consumer product exposure warnings], where a warning for a consumer product exposure or occupational exposure from use of a pesticide is provided on a product label, and the pesticide label is regulated by the United States Environmental Protection Agency under the Federal Insecticide, Fungicide, and Rodenticide Act, Title 40 Code of Federal Regulations, Part 156; and by the California Department of Pesticide Regulation under Food and Agricultural Code section 14005, and Cal. Code of Regs., title 3, section 6242; the word “ATTENTION” or “NOTICE” in capital letters and bold type may be substituted for the word “WARNING.”
OEHHA states this is intended to be a “narrow exception” and that it is only intended to apply where EPA and California Department of Pesticide Regulation (CDPR) signal words and the Proposition 65 (Prop 65) signal word conflict. This proposal is intended to address the concerns of pesticide registrants encountering problems when they attempted to amend their EPA-approved labels to include the Prop 65 “WARNING” signal word. It remains unclear, however, whether the OEHHA proposal will fully address EPA’s concerns, and what effect it will have on EPA’s ability to approve labels that contain the language at issue. Registrants should review the proposal carefully and monitor closely EPA’s actions concerning it and this issue more generally.
Comments are due by June 11, 2018, and can be submitted to OEHHA via its website. OEHHA states that any requests for a public hearing on this proposed regulatory amendment should be submitted by May 25, 2018.
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.”