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 J. Brian Xu, M.D., Ph.D., DABT®
On June 1, 2017, in the People’s Republic of China (China), a newly revised Regulation on Pesticide Administration (RPA) became effective. The newly revised RPA was approved during the 164th executive meeting of the State Council of China on February 8, 2017 and published as Decree Number 677 of the State Council of China (in Chinese only) (China Decree 677) on April 1, 2017.
The first version of the RPA became effective on May 8, 1997, and was revised on November 29, 2001, by China Decree 326. China Decree 677 makes significant changes to the current version of RPA (China Decree 326), and requires the Ministry of Agriculture (MOA) to formulate relevant rules and measures for its implementation. The revised RPA includes eight chapters: General Provisions; Pesticide Registration; Production of Pesticides; Distribution of Pesticides; Uses of Pesticides; Supervision and Management; Legal Liability; and Supplementary Provisions.
On March 17, 2017, the MOA released five implementation measures for public comments (in Chinese only) but did not provide an implementation date. The measures include: Pesticide Registration Management Measures (Draft); Measures for the Management of Pesticide Production License (Draft); Measures for the Administration of Pesticide Business License (Draft); Measures for the Administration of Pesticide Labels and Manuals (Draft); and Measures for the Management of Tests Used for Pesticide Registration (Draft).
The new RPA is intended to: streamline the administration process; implement licensing systems for pesticide production and distribution; promote the reduction of pesticide uses and enhance the management of highly toxic pesticides; clarify the responsibilities of manufacturers, sponsors of the contracted manufacturers, and distributors for the safety, efficacy, and quality of pesticides; establish pesticide recall and pesticide waste recycling systems; and prevent and punish the adulteration of pesticides. The new RPA also revises the registration process and labeling requirements of pesticides, removes temporary pesticide registration, includes increased fines and blacklisting, and requires that manufacturers and distributors/retailers of pesticides establish a tracking system and maintain the required records for at least two years.
The new RPA significantly changed registrations for pesticides in China. Temporary pesticide registration is no longer an option. There were two registration review committees: the Temporary Pesticide Registration Review Committee that held a review meeting every two months; and the Full Pesticide Registration Review Committee that held a review meeting every six months, before the new RPA became effective. The two committees are being replaced by the National Pesticide Registration Review Committee, but no frequency of review meetings was provided. It is expected that the National Pesticide Registration Review Committee will meet less frequently than once every two months, which may result in a longer timeline for review and approval. Without temporary pesticide registrations, a full set of data will be required with every pesticide registration, including two-year stability data in the initial submission. Therefore, the new pesticide registration process may extend the time for manufacturers to bring products to the Chinese market.
The new RPA requires the foreign registration of active ingredients; possibly new formulations will obtain the registration in another country before registering it in China.
In addition, the Pesticide Registration Management Measures (Draft) requires that chemistry and toxicology tests should be completed in laboratories approved by the MOA or overseas laboratories maintaining mutual recognition agreements with the Chinese Government and complying with Good Laboratory Practices (GLP), and that efficacy, residue, and environment tests shall be conducted in China. Since China is not a member country of the Organization for Economic Cooperation and Development’s (OECD) Mutual Acceptance of Data (MAD) system, this proposed requirement could reject all test reports from overseas for pesticide registration in China. It also requires that literature or data in a foreign language shall be translated to Chinese, but is not clear if the whole article/reports or only the summary should be translated into Chinese. The timeline for new data requirements on pesticide registration under the new RPA is not provided. Many questions for pesticide registration under the new RPA remain.
By Lisa M. Campbell, Jason E. Johnston, M.S., and James V. Aidala
On May 25, 2017, the U.S. Environmental Protection Agency (EPA) announced the release of ecological risk assessments for four neonicotinoid active ingredients for public comment as well as the Registration Review Update for Four Neonicotinoid Insecticides (Update). 82 Fed. Reg. 24113. The ecological risk assessments are:
EPA states that public comments “could address, among other things, the Agency’s risk assessment methodology and assumptions applied to its draft risk assessments, such as its methodology for estimating colony-level risk to bees from exposure to bee bread.” Comments on the three ecological risk assessments are due by July 24, 2017.
The main focus of the Update document is EPA’s efforts to harmonize the risk assessment and management of the four neonicotinoids during registration review. EPA has identified additional pollinator exposure data and pollinator toxicity data needs; registrants have committed to producing the needed data, and most of the data will be submitted in 2017. EPA plans to produce final pollinator risk assessments for both agricultural and non-agricultural uses in 2018. Release of non-pollinator risk assessments (i.e., aquatic organisms, terrestrial mammals, and birds) is planned for 2017. Human health risk assessments are also scheduled to be issued in 2017. EPA has stated that mitigating risk from the uses of all neonicotinoids may be considered for all four compounds at the same time to ensure consistent risk management and to prevent unnecessary shifts in usage between the compounds without a reduction in risk. EPA intends to release final pollinator assessments and proposed interim decisions for registration review for all four neonicotinoids in 2018.
From the EPA website, the following general statement summarizes what EPA has found so far:
- The assessments for clothianidin, thiamethoxam, and dinotefuran, similar to the preliminary pollinator assessment for imidacloprid showed: most approved uses do not pose significant risks to bee colonies. However, spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.
To some degree, it is reassuring that widespread adoption of the neonicotinoid products appears not to be an overwhelming or altogether unanticipated risk to pollinators. For insecticides, that foliar spray applications could be harmful is not good news, as any direct contact of an insect (bees) and insecticides usually is not good for the health of the insect.
Another point some may find reassuring is that EPA has not found seed treatment with neonicotinoid products to be of significant risk. This is ironic to some degree, since one of the fundamental assumptions not long ago among many beekeepers was that the seed treatment products were a singular and significant cause of the increase in colony decline and loss.
EPA’s description of the registration review status of these products also indicates that a great volume of additional data concerning possible pollinator risks is due to arrive over the next six to 18 months. Obviously, the results of these additional studies will fundamentally inform the EPA risk assessment conclusions. At the same time, one legacy of the Obama Administration in this space, the development of state Manage Pollinator Protection Plans (MP3), also will be impacted by what EPA discovers from this volume of soon-to-arrive data.
Until then, and until the new political leadership of the agency indicates any direction on pollinator issues, it is unclear whether the pollinator issue will remain one of the priority issues for program attention, or be folded into the general timeline and normal course or registration review over the next few years.
By Jason E. Johnston, M.S.
On May 31, 2017, the U.S. Environmental Protection Agency (EPA) announced the release of its Food Contact Sanitizing Solutions Model (FCSSM), a pesticide risk assessment model that has been developed to “estimate indirect dietary exposure to components of sanitizing solutions used in commercial settings.” EPA states that “the model offers guidance for estimating exposure where there may be inadvertent transfer of residue to edible items prepared or transported on surfaces treated with these pesticides.” The model consists of spreadsheets that automatically calculate dietary exposure and risk estimates based on data entered by the user. The model estimates exposures to antimicrobial active ingredients listed under 40 C.F.R. § 180.940(b) and 40 C.F.R. § 180.940(c), where 940(b) includes uses in dairy processing equipment and food processing equipment and utensils, while 940(c) excludes dairy processing equipment. FCSSM does not apply to active ingredients listed under 40 C.F.R. § 180.940(a), which are used on food contact surfaces in public eating places as well as dairy and food processing equipment. For this case, EPA’s established methodology remains in place. Compared to the simple calculation method used previously for these use scenarios, the major new feature of the FCSSM is the separate calculations of both acute and chronic dietary exposures for the general U.S. population and eight subpopulations. EPA also released a user guide that provides background information on the model and familiarizes users with the inputs required to run the model.
More information about the FCSSM as well as other models used for pesticide risk assessments is available on EPA’s website.
By Lynn L. Bergeson and Carla N. Hutton
On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of a nanosilver pesticide product and vacated the conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC) as well as the Center for Food Safety (CFS) and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named NSPW-L30SS (NSPW). The court vacated the conditional registration because, according to the court, “EPA failed to support its finding that NSPW is in the public interest.”
When EPA granted the conditional registration, EPA did so on the basis that NSPW had a lower application rate and a lower mobility rate when compared to conventional-silver pesticides, and thus had the potential to reduce environmental loading and risk caused by silver release. Petitioners disputed these facts. While the court found that substantial evidence supports EPA’s findings that NSPW has lower application and mobility rates, the court agreed that the third premise, that current users of conventional-silver pesticides will switch to NSPW and/or that NSPW will not be incorporated into new products, “impermissibly relies on unsubstantiated assumptions.” According to the court, EPA cites no evidence in the record to support its assumption that current users of conventional-silver pesticides will switch to NSPW (“the substitution assumption”), but contends that it will occur as a “logical matter.” The court states that the lack of evidence supporting the substitution assumption is problematic in light of EPA’s other unsupported assumption, that there will be no new products. The court notes that EPA assumes current users of conventional-silver pesticides will switch to NSPW because of its benefits, but that these same benefits will not prompt manufacturers to incorporate NSPW into new products. EPA could have proved these assumptions, but without evidence in the record to support the assumptions, the court states that it “cannot find that the EPA’s public-interest finding is supported by substantial evidence as required by [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” According to the court, the public interest finding is an “essential prerequisite to conditional registration,” and EPA failed to support that finding for NSPW with substantial evidence. The court vacated the conditional registration in whole, and did not consider the remaining issues raised by petitioners.
More information will be available in Bergeson & Campbell, P.C.’s memorandum Appellate Court Vacates Conditional Nanosilver Registration.
By Susan M. Kirsch
On May 24, 2017, the U.S. House of Representatives passed H.R. 953, the Reducing Regulatory Burdens Act of 2017, by 256-165 vote. H.R. 953, which is similar to bills introduced in the past three congresses, would overturn a 2009 U.S. Court of Appeals for the Sixth Circuit decision requiring Clean Water Act (CWA) National Pollutant Discharge Elimination System (NPDES) permits for pesticide spraying activities into, over, or near waters. The legislation would eliminate NPDES permitting for pesticide spraying that complies with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Proponents of the legislation assert that the addition of CWA regulation is duplicative, burdensome, and costly for industry without resulting in any additional environmental benefits. Opponents argue that the bill would strip clean water protections for waters already listed as impaired for pesticides. Championed by Representative Bob Gibbs (R-OH), the recent vote received significant bipartisan support, with twenty-five Democrats voting in support of the bill. Senators Claire McCaskill (D-MO) and Mike Crapo (R-ID) introduced companion legislation in the Senate (S. 340), which currently awaits action by the Committee on Environment and Public Works. The prospects for a Senate vote are mixed in light of the number of confirmations in the queue for political appointees, as well as big ticket legislative priorities, such as health care and tax reform. If legislation is enacted, it would only apply to the four states (Idaho, New Hampshire, New Mexico, and Massachusetts), tribal lands, and other federally managed areas that are governed by the federal NPDES permit. Forty-six states administer state versions of pesticide permits. Mmany states would be expected to phase out permitting if the federal requirement is eliminated, however.
More information regarding CWA NPDES issues is available on our blog under key word NPDES.
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 Lynn L. Bergeson and Margaret R. Graham
In a May 11, 2017, letter from U.S. Environmental Protection Agency (EPA) Acting Assistant Administrator Wendy Cleland-Hamnett to the CEO of the National Association of State Departments of Agriculture (NASDA) posted by Bloomberg’s BNA Daily Environment Report, Cleland-Hamnett states that it is appropriate to grant NASDA’s request to delay implementation of all revised provisions to the agricultural Worker Protection Standard (WPS) “until the necessary guidance and training have been completed which would allow state lead pesticide agencies to successfully implement the rule changes.” EPA has not yet issued any formal delay notifications.
The May 11, 2017, letter was sent in response to a February 17, 2017, letter from NASDA (February 21, 2017, per the NASDA website) that requested EPA to extend the WPS “until at least January 2, 2018, or until adequate enforcement guidance, educational materials, and training resources have been completed and the state lead agencies have the tools, time, and resources necessary to effectively implement the rule changes and assist the regulated community with compliance activities.” This letter was not submitted in the WPS docket in response to a request for comment, but pursuant to a NASDA membership decision. NASDA states in the letter that the new WPS regulations require “significant additional staff time to provide sufficient outreach to workers, handlers, applicators, agricultural employers, trainers and other stakeholders,” and that “the enhanced compliance and record keeping requirements require a robust delivery and understanding of educational resources and training materials to assist [state lead agencies] and the regulated community in understanding, complying, and enforcing the new requirements.”
The WPS final rule including updates and revisions to the existing worker protection regulations for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) became effective on January 1, 2016, and on January 4, 2017, agricultural employers and handler employers were required to comply with all of the new requirements set forth in the final rule – with the exception of two requirements that would be implemented not before January 2018. More information on the final rule is available in our blog item EPA Publishes Worker Protection Standard Final Rule.
By Lisa M. Campbell, Lara A. Hall, and Margaret R. Graham
On May 8, 2016, the U.S. Environmental Protection Agency (EPA) announced its invitation for public input regarding the “Strategic Roadmap: New Approaches to Evaluate the Safety of Chemicals and Medical Products” (Roadmap), the development of which was coordinated by the National Toxicology Program’s (NTP) Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM states that the vision of the Roadmap is to “establish new approaches for evaluating the safety of chemicals and medical products in the United States that will increase confidence in alternative methods and improve their relevance to human health outcomes while maximizing efficiency and maintaining a commitment to replace, reduce, and refine animal use.” ICCVAM’s Roadmap effort was introduced in March 2016. A detailed presentation on the development of the Roadmap is available here.
ICCVAM, a permanent committee of the National Institute of Environmental Health Sciences (NIEHS) under the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), is composed of representatives from 16 U.S. federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. As a participating member of ICCVAM, EPA states that its role is to “encourage the development and use of alternatives to animal test methods, ensure that new methods are valid, review test method recommendations, and as appropriate, adopt these alternatives in our own regulatory programs.”
There are also three upcoming public meetings that will provide additional opportunities to comment on topics relevant to this effort:
- ICCVAM Public Forum: May 23, 2017, National Institutes of Health (NIH), Bethesda, Maryland;
- NTP Board of Scientific Counselors meeting: June 29, 2017, NIEHS, Research Triangle Park, North Carolina; and
- Scientific Advisory Committee on Alternative Toxicological Methods meeting: September 18-19, 2017, NIH, Bethesda, Maryland.
As ICCVAM’s commitment to replace, reduce, and refine animal use continues to draw public comment and gain support, there is an increasing need to demonstrate the utility and harmonization of predictive approaches in toxicology testing with the conventional safety evaluation of chemicals and medical products. Bergeson & Campbell, P.C. (B&C®) continues to monitor the development, validation, and implementation of alternative in vitro and in silico test methods, high throughput screening assays, and computational models as they are integrated into global regulatory frameworks.
By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham
On April 27, 2017, Senator Elizabeth Warren (D-MA) and Representative Frank Pallone (D-NJ) sent a letter to Inspector General Arthur Elkins, Jr. at the Office of Inspector General (OIG) at the U.S. Environmental Protection Agency (EPA) requesting the OIG to conduct an investigation into EPA’s March 29, 2017, order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos. The letter refers to the March 29, 2017, order as “Administrator Scott Pruitt’s order,” and asks OIG to address questions specifically targeting the rationale, communications, and consideration that Administrator Pruitt took prior to reaching the decision.
The letter states that Administrator Pruitt's “hasty reversal of this decision … appears not to be based on EPA’s existing recent scientific findings about the risk, or any new information that contradicts the findings about the health and safety risks of chlorpyrifos.” Further, the letter asserts that “it does not appear to be consistent with the law, which requires that pesticide products cannot be used unless ‘there is reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical residue.’”
- How did Mr. Pruitt reach the decision he announced on March 29, 2017? What was the timeline leading up to this decision? With whom did he communicate within EPA, the White House, or elsewhere in the Administration? With which outside entities did he communicate? Specifically, did Mr. Pruitt have any communication with staff or representatives of Dow Chemical or any pesticide industry trade groups including CropLife America?
- What was the rationale for Mr. Pruitt's decision, and why did he reverse an agency decision that had been years in the making? How was this rationale developed? Was it based on any new information or evidence?
- Was Mr. Pruitt's decision consistent with the requirements of the Administrative Procedures Act? Did he provide appropriate notice and comment and appropriately consider all relevant comments and information?
- Was Mr. Pruitt's decision consistent with the requirements of the FFDCA, which establishes a standard that, to maintain a pesticide tolerance, there must be "reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical petitition to revoke tolerances.pdf residue"? Has the EPA met the "reasonable certainty [of] no harm" standard in the law? Why did Mr. Pruitt note that chlorpyrifos was "widely used" when he announced his decision? Was this "wid[e] use" a factor in Mr. Pruitt's decision, and, if so, was this appropriate under the law? What other factors were taken into consideration by Mr. Pruitt?
- Is the EPA accurately and transparently presenting information to the public with regard to previous EPA actions concerning chlorpyrifos? For example, the EPA website for chlorpyrifos on January 2, 2017 contained information indicating that EPA "proposed to revoke all chlorpyrifos tolerances," and contained a link with detailed information about the health risks and the reasons for the EPA action. This reference to the proposed ban, and the link to the detailed EPA analysis are no longer available on the chlorpyrifos web page, and the link to the analysis (as of April 3, 201 7) now gives a "Page Not Found" error.
This letter not surprisingly continues the debate over the appropriate regulatory status of chlorpyrifos. Those disappointed by the recent EPA decision, apparently including Senator Warren and Representative Pallone, want to press EPA to explain in more detail not only the reasons for the decision not to revoke chlorpyrifos tolerances at this time, but also the rationale EPA used to rebut what they believe to be the decision-making record that EPA had accumulated over the last two to three years.
The explanation that the arrival of new leadership at EPA with the Administration led to a change in position is perhaps only part of the answer. The change in Administration did not change the underlying statutory requirements governing EPA’s registration, reregistration, and tolerance decisions, and EPA relied on these requirements as the basis for its decision not to make a decision at this time, as discussed in EPA Denies Petition to Ban Chlorpyrifos.
EPA’s response to any investigation initiated by this letter, as well as the OIG response, will be watched closely by all stakeholders.