By Jason E. Johnston, M.S.
On May 23, 2018, the U.S. Environmental Protection Agency (EPA) held an “Environmental Modeling Public Meeting” (EMPM). As stated in the April 12, 2018, Federal Register notice announcing the meeting, the “EMPM provides a public forum for EPA and its stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for pesticide risk assessments in a regulatory context.” The overall theme of the EMPM was the quantitative use of surface water monitoring data.
The morning session featured a series of presentations by representatives from EPA, the U.S. Geological Survey (USGS), and the Washington State Department of Agriculture concerning the development of a framework to use surface water monitoring data quantitatively in pesticide risk assessments. A major focus of the presentations was the exploration and evaluation of the capabilities of the USGS recently-developed model SEAWAVE-QEX to improve the robustness of surface water monitoring datasets so that they might be used in pesticide risk assessments. Further public presentations on the evaluation and development of the framework are scheduled at the American Chemical Society meeting to be held on August 19-23, 2018, in Boston, Massachusetts. There are plans to hold a Scientific Advisory Panel meeting on the framework in 2019, but no exact date has been set.
The afternoon session consisted of presentations by representatives of the registrant community. Topics addressed included developments in the use of surface water monitoring data in quantitative risk assessment, a statistical analysis of non-targeted monitoring data at the watershed scale, the creation of a curated database of water and sediment monitoring data for synthetic pyrethroids, the use of high-resolution spatial and temporal monitoring data to parameterize watershed scale drift exposure predictions, and an evaluation of model predictability using monitoring data and refined pesticide use at the watershed level.
Presentations from the May 23, 2018, EMPM will soon be posted to Docket No. EPA-HQ-OPP-2009-0879, accessible at www.regulations.gov.
Registrants should monitor these activities, as this effort at EPA represents a potential shift away from the current reliance exclusively on estimated water concentrations in quantitative human health and ecological risk assessments.
By Lisa M. Campbell and Lisa R. Burchi
On April 30, 2018, the U.S. District Court for D.C. issued a memorandum opinion that sets forth the reasons for its denial of defendant Monsanto Company’s (Monsanto) motion to dismiss in a case in which the plaintiffs allege that certain glyphosate label claims violate the District of Columbia Consumer Protection Procedures Act (DCCPPA) (Opinion). The order denying Monsanto’s motion to dismiss was issued on March 31, 2018, but did not provide any substantive discussion as to why it was denied, only that a statement that the reasons would be provided in 30 days.
Plaintiffs Beyond Pesticides, et al.’s amended complaint alleges that under the DCCPPA “the claim that Roundup targets an enzyme ‘found in plants but not in people or pets’ is false and misleading because that enzyme ‘is found in people and pets’” (emphasis in original), because, plaintiffs assert, “glyphosate, the active ingredient in Roundup, targets an enzyme that exists in ‘gut bacteria’ found in humans and other mammals.” The amended complaint additionally alleges that Monsanto “is aware that its labels and advertising are false … but continues to repeat this claim because ‘consumers are more likely to buy -- and will pay more for -- weed killer formulations that do not affect people and animals.’”
Monsanto’s motion to dismiss, filed on July 10, 2017, stated that plaintiffs’ “claims are time-barred, that Plaintiffs fail to state a claim because the statement at issue is not false or misleading, and that Plaintiffs’ claims are preempted by [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].”
The Opinion outlines the reasons for the court’s conclusion that the claims are not time-barred, at least for purposes of deciding the motion to dismiss. The Opinion states, in response to some of the arguments that the claims were time-barred, that the court has “little trouble concluding that Plaintiffs’ claims are not time-barred in their entirety,” and that Monsanto is “entitled to renew its argument that some portion of Plaintiff’s claims are time-barred at the summary judgment stage.”
With regard to the court’s decision that plaintiffs “have adequately pleaded a claim” that Roundup’s label is false or misleading under the DCCPPA, the Opinion states: “Roundup supposedly targets an enzyme that is not found in people or animals, but that enzyme is, in fact, found in their gut bacteria.” Moreover, the Court notes that “even if the statement on Roundup’s label is not ‘literally false,’ Plaintiffs have also alleged that it is also misleading.” For these reasons, the Opinion states, the Court “cannot conclude that ‘no reasonable person would be deceived’ by the Roundup label, such that dismissal of Plaintiffs’ claims would be appropriate.”
Perhaps of most interest is the Opinion’s discussion of the preemption claim in light of the fact that the claims at issue are claims approved on multiple occasions by the U.S. Environmental Protection Agency (EPA) as part of its approval of the label. The Opinion states that “Plaintiffs’ claims are not preempted because the DCCPPA, as it relates to pesticide labels, does not impose a broader or different obligation than FIFRA.” Rather, “[u]nder both statutes, false or misleading statements on a pesticide label are proscribed.” The Opinion cites the Supreme Court case Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) in stating that “the question is not whether the statute reaches conduct beyond such labeling,” but “whether the statute ‘impose[s] a labeling requirement that diverges from those set out in FIFRA and its implementing regulations’” (emphasis in original). Moreover, the Opinion finds that a request for declaratory relief is not “functionally a requirement that the company change its label.” Instead, the Opinion distinguishes between the declaration that plaintiffs seek, that Monsanto’s label violates the DCCPPA, and an injunction stating that the declaratory relief requested “would not require Monsanto to change its label, even though it might well ‘induce’ it to do so” (emphasis in original). The Court found that for this reason the requested relief is not preempted by FIFRA.
Registrants should pay attention to the potential implications of this case, and others like it, particularly with regard to label claims that EPA has approved. More information on other glyphosate issues is available on our blog.
By Lisa M. Campbell and Lisa R. Burchi
On March 8, 2018, the U.S. Environmental Protection Agency (EPA) announced its release of final guidance clarifying where first aid statements should appear on the label of pesticide products. EPA also posted a response to public comments. Links to the final guidance and to the response to public comments documents are below:
EPA states that it was prompted to develop this guidance when it learned “that there was a discrepancy in how the ‘location of first aid statement,’ per [40 C.F.R. Section 156.68(d)] is interpreted by EPA and those in the pesticide registrant community.” EPA notes that its review and approval of pesticide labeling is generally of a “master” label and thus does not always include a review of the location or placement of specific language on a label.
On December 7, 2016, EPA posted a memorandum for public comment entitled “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement and Clarification on Definition of Label ‘Panel’ per 40 CFR 156.68” to clarify the interpretation of the term “panel” in the context of 40 C.F.R. 156.68 and to clarify where first aid statements must appear on pesticide labels, based on their Toxicity Category.
In its final guidance, EPA states it “will continue to require that Toxicity Category I products have the first aid statements on the front panel except in cases where a variation has been approved.” Further, based on comments received and the wide reliance by the regulated community on the interpretation that “any panel” includes inside panels, EPA is changing its position from its 2016 memorandum and now “will not require Toxicity Category II and III products to bear the first aid statements on a visible front, back or side panel.”
EPA also listed three recommendations for registrants to consider when printing their container labels:
- For Toxicity Category I products, EPA strongly recommends that registrants consider placing duplicative first aid language on the very back page of the booklet/accordion/saddle stitch label that is immediately “stuck” to the container in case the booklet/accordion/saddle stitch label is accidentally removed.
- Regardless of whether a registrant chooses to place the first aid statements for Toxicity Categories II and III products on a visible front, back, side or inside panel, EPA recommends that duplicative first aid language appear on the very back page of the booklet/accordion/saddle stitch label that is immediately attached to the container in case the booklet/accordion/saddle stitch label is accidentally removed. EPA states that this recommendation is not intended to suggest other information that registrants typically include on the very back page should be moved elsewhere.
- EPA recommends that the registrant community consider designing new booklets/accordion/saddle stitch labels that are not easily removed from the containers. Per 40 C.F.R. Part 156.10(a)(4), the labels are to be “securely attached” to the immediate container of the pesticide product. EPA believes that in many instances these labels are easily removed which is why, EPA states, it believes many registrants have already chosen to put the duplicative first aid statements on the very last page of the label that is attached to the container.
Registrants should review this guidance carefully, as this issue has been the subject of concern and controversy for a number of registrants.
By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham
On March 6, 2018, the U.S. Environmental Protection Agency (EPA) issued a proposed rule (pre-publication version available here) to add hazardous waste aerosol cans to the category of universal wastes regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations (Title 40 of the C.F.R., Part 273), entitled Increasing Recycling: Adding Aerosol Cans to the Universal Waste Regulations. EPA cites as authority for this change Sections 2002(a), 3001, 3002, 3004, and 3006 of the Solid Waste Disposal Act, as amended by RCRA, as amended by the Hazardous and Solid Waste Amendments Act (HSWA). EPA states the streamlined Universal Waste regulations are expected to:
- Ease regulatory burdens on retail stores and other establishments that discard aerosol cans by providing a clean, protective system for managing discarded aerosol cans;
- Promote the collection and recycling of aerosol cans;
- Encourage the development of municipal and commercial programs to reduce the quantity of these wastes going to municipal solid waste landfills or combustors; and
- Result in an annual cost savings of $3.0 million to $63.3 million.
As aerosol cans are “widely used for dispensing a broad range of products” including pesticides, the proposed rule may have implications for chemical companies that create and distribute pesticide products marketed in aerosol cans. Hazardous waste aerosol cans that contain pesticides are also subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements, including compliance with the instructions on the product label. Under 40 C.F.R. Section 156.78, a flammability label statement is required for pressurized pesticide product products that states “Do not puncture or incinerate container,” but EPA’s 2004 determination (that will be posted to Docket No. EPA-HQ-OLEM-2017-0463 on www.regulations.gov for this proposed rule) allows for the puncturing of cans. The proposed rule states:
- EPA issued a determination that puncturing aerosol pesticide containers is consistent with the purposes of FIFRA and is therefore lawful pursuant to FIFRA section 2(ee)(6) provided that the following conditions are met:
- The puncturing of the container is performed by a person who, as a general part of his or her profession, performs recycling and/or disposal activities;
- The puncturing is conducted using a device specifically designed to safely puncture aerosol cans and effectively contain the residual contents and any emissions thereof; and
- The puncturing, waste collection, and disposal, are conducted in compliance with all applicable federal, state and local waste (solid and hazardous waste) and occupational safety and health laws and regulations.
- EPA anticipates that this 2004 FIFRA determination would not be affected by the proposed addition of hazardous waste aerosol cans to the universal waste rules.
Comments will be due 60 days after the proposed rule’s publication in the Federal Register.
By Heather F. Collins, M.S. and Margaret R. Graham
On February 28, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of three Group B -- Antimicrobial Efficacy Test Guidelines, under Series 810, Product Performance Test Guidelines. The guidelines provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides against public health microbial pests. 83 Fed. Reg. 8666. The three final guidelines are:
EPA states these “test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols for testing that is intended to provide data to inform regulatory decisions.”
EPA issued draft guidelines in June 2015 and solicited comments. EPA states that some comments received on those draft guidelines have been incorporated into the final versions. EPA states that the revision “is more user friendly and clarifies topics such as confirmatory data, repeat testing, hard water formulation, wetness determination testing for towelettes, and internal toilet testing … [and] also includes information on supplemental testing policies such as lower certified limits, revision of the AOAC Use Dilution Method performance standards and clarified technical details for efficacy testing.”
Documents pertaining to the revision of the product performance guidelines, including public comment submissions, and the agency’s response to comments are available at www.regulations.gov, in Docket No. EPA-HQ-OPP-2015-0276. More information on test guidelines is available on our blog.
By Lynn L. Bergeson and Margaret R. Graham
The American Bar Association (ABA) Pesticides, Chemical Regulation, and Right-to-Know (PCRRTK) Committee is collaborating with David Rejeski, Director of the Technology, Innovation, and Environmental Project at the Environmental Law Institute (ELI), on a project involving the law, regulation, and policy of cannabis. David has written extensively on the topic, one example of which is his article “Cannabis. The ‘Next Big Thing’ for the Environment?”
Federal Insecticide, Fungicide, and Rodenticide (FIFRA) practitioners likely noticed the cannabis item on the most recent State FIFRA Issues Research and Evaluation Group (SFIREG) meeting agenda. Also, the state of Colorado is preparing a white paper on cannabis. Many other initiatives are in play as well.
The newly formed Task Group will outline legal, regulatory, and policy issues pertinent to cannabis as a crop, the absence of tolerances, its impact on the environment, and a wide range of related issues.
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, Lisa R. Burchi, and James V. Aidala
On July 18, 2017, a panel of three judges at the U.S. Court of Appeals for the Ninth Circuit issued an order denying petitioners’ Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) Motion for Further Mandamus in the chlorpyrifos proceedings. In that motion, Petitioners asked the court to grant further mandamus relief, asserting that the U.S. Environmental Protection Agency’s (EPA) denial of Petitioners’ petition to revoke all food tolerances and cancel all chlorpyrifos registrations was inadequate because it contained “no new safety findings” and no “final determination as to whether chlorpyifos food tolerances must be revoked.” More information on the motion is available in our blog item Petitioners File Motion for Further Mandamus Relief in Response to EPA’s Order Denying Petition to Ban Chlorpyrifos.
In its order, the panel held that since the prior mandamus proceedings “addressed the timing, not the substance, of EPA’s response,” EPA had “complied with the panel’s previous orders by issuing a ‘final response to the petition.’” The mandamus motion thus was “premature, and its substantive objections to the EPA’s denial must first be made through the administrative process mandated by statute.”
The demand imposed by the court earlier was to make a decision, and EPA met that deadline with its denial. This is a significant win for industry, but is far from the end of this debate, which will continue in a number of different forums. More information on the proceedings is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell and Margaret R. Graham
On June 14, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. 82 Fed. Reg. 27254. EPA states that this test guideline provides “guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA,” and “recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products intended to repel, attract, and/or kill the common bed bug (Cimex lectularius) in connection with registration of pesticide products under the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” EPA states that this guidance applies to products “in any formulation such as a liquid, aerosol, fog, or impregnated fabric, if intended to be applied to have a pesticidal purpose such as to attract, repel, or kill bed bugs.” This guideline provides appropriate laboratory study designs and methods for evaluating the product performance of pesticides against bed bugs and includes statistical analysis and reporting.
EPA issued the draft guideline on February 14, 2012. This original document was the subject of FIFRA Scientific Advisory Panel (SAP) review conducted on March 6-7, 2012. EPA indicates that the final version of the guideline reflects revisions to the original draft based on comments from the SAP and the public. EPA states that the revisions include the following:
- Decreasing the number of individuals and replicates tested;
- Rescinding the recommendation to test each field strain for its resistance ratio; and including a resistance management statement;
- Clarifying the agency's Good Laboratory Practices (GLP) requirements;
- Reducing the recommended length of time individuals are exposed to insecticides;
- Recommending individuals to be observed up to 96 hours after treatment; and
- Revising the statistical analyses recommendations.
EPA has also placed two other relevant documents in the docket:
By Lisa M. Campbell and James V. Aidala
On April 5, 2017, Petitioners Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) filed a Motion for Further Mandamus Relief in the Ninth Circuit Court of Appeals proceedings regarding the chlorpyrifos tolerances. In the motion, Petitioners respond to the U.S. Environmental Protection Agency’s (EPA) order signed on March 29, 2017, which denied the petition to revoke tolerances. Petitioners state that EPA’s response to the petition (the order) is “no response at all and not what this Court ordered EPA to do,” and asks the court to “grant further mandamus relief, giving EPA 30 days to act on its findings that chlorpyrifos exposures are unsafe and to establish deadlines for the next steps in the revocation and cancellation processes for chlorpyrifos.” Specifically, Petitioners request that the court order EPA to:
- Take regulatory action within 30 days on its finding that chlorpyrifos is unsafe and “make it abundantly clear that what is required within 30 days is final regulatory action based on the neuro-developmental and other risks posed by chlorpyrifos exposures”;
- Resolve objections to its final regulatory action within 60 days, as opposed to “as soon as practicable after receiving the arguments of the parties,” because, Petitioners assert, EPA otherwise may put off their response for a long period of time;
- Require EPA to issue a notice of intent to cancel all chlorpyrifos uses within 60 days, “consistent with its risk assessments and findings that chlorpyrifos is unsafe,” as it has “found drinking water contamination from all chlorpyrifos uses, including nonfood uses, and will need to take regulatory action to end such uses in addition to stopping food uses”; and
- File six-month status reports until the tolerance revocation process and the cancellation proceedings are complete.
It is no surprise that the Petitioners who were disappointed by EPA’s denial of the petition one week ago have now continued their advocacy against the use of chlorpyrifos. As we note in our previous blog item EPA Denies Petition to Ban Chlorpyrifos, EPA articulated its reason for the denial as of this time, but this in itself did not articulate its determination that the registration and associated tolerances met the requirements of the Food Quality Protection Act (FQPA). EPA’s response to this latest legal skirmish will be of interest, as will the court’s response to it. .
More information on the proceedings is available on our blog under key word chlorpyrifos.