Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.
NMFS Issues New BiOp for Pesticide Effects on Pacific Salmon, but the Methodology Used and Mitigation Proposed Remain Controversial
On January 20, 2015, the National Marine Fisheries Service (NMFS) issued its latest Biological Opinion (BiOp) in a series of BiOps evaluating potential effects of pesticide use on salmon in the Pacific Northwest. When the U.S. Environmental Protection Agency (EPA) decides to permit continued registration of a pesticide (during reregistration or registration review), Endangered Species Act (ESA) Section 7(a)(2) requires EPA to determine, in consultation with the NMFS and/or the Fish and Wildlife Service (FWS), that continued registration is not likely to jeopardize the continued existence of any endangered or threatened species. Under current procedures, EPA scientists make an initial threshold determination whether or not continued registration “might” have such an effect, followed by referral to the FWS or the NMFS for formal consultation in those instances where that threshold is met.
The January 20, 2015, NMFS BiOp concerns the pesticides diflubenzuron, fenbutatin oxide, and propargite, and is one in a series of NMFS BiOps for Pacific salmon. As part of litigation that began in 2001, the Ninth Circuit Court of Appeals ordered EPA to determine whether it should have consulted with NMFS concerning reregistration of 55 specific pesticides. EPA subsequently initiated a formal consultation with NMFS for 37 of these 55 pesticides.
Like most of the prior BiOps, the latest NMFS BiOp recommends that EPA require the affected pesticide registrants to adopt buffer zones and other mitigation measures. The scientific methodology underlying the NMFS BiOps has been sharply criticized by industry and questioned by EPA. EPA has not yet adopted the measures recommended by NMFS in any of the previous BiOps. The BiOp for the pesticides chlorpyrifos, diazinon, and malathion was vacated and remanded to NMFS by the Fourth Circuit Court of Appeals on February 21, 2013. That decision was based in part on use of implausible assumptions in the NMFS model and on the decision of NMFS to recommend uniform buffer zones without regard to site-specific factors. Industry has criticized the latest BiOp on similar grounds. Some may also ask why NMFS did not utilize methodology like that recommended in 2013 by a panel of the National Academy of Sciences, but NMFS states that consultations with other agencies concerning a process to implement the NAS recommendations are still pending.
Along with the release of the revised human health risk assessment for chlorpyrifos, in late December 2014, the U.S. Environmental Protection Agency (EPA) filed a Response to the Petition for a Writ of Mandamus that the Pesticide Action Network North America and the Natural Resources Defense Council, among others, filed in September 2014 in the U.S. Court of Appeals for the Ninth Circuit. This action is the latest of several brought to try to achieve a ban of chlorpyrifos and a revocation of food tolerances for chlorpyrifos.
EPA’s December 2014 response states that its “thorough consideration of these issues will inform its ultimate decision whether to leave in place the tolerances for chlorpyrifos or cancel chlorpyrifos registrations, and a full record will facilitate any subsequent judicial review of those decisions.”
On January 7, 2015, EPA included in a status report to the court the issuance of its revised human health risk assessment. EPA indicated that currently it plans to “issue a proposed rule to revoke tolerances in early 2015 or a final denial order in mid-2015.”
It is not clear what EPA implies by stating that it could issue a proposed tolerance revocation in “early 2015” when the assessment of chlorpyrifos has only recently been released, availability announced in the Federal Register on January 14, 2015, and there is an open comment period on the document scheduled to close on March 16, 2015. Any action would presumably take some time, given the need to review submitted comments and formulate a response. Preparing any regulatory action would take some additional amount of time, especially since registrants of chlorpyrifos products can be expected to have substantial comments on the documents.
On January 5, 2015, the Natural Resources Defense Council (NRDC) filed a petition for review in the U.S. Court of Appeals for the Ninth Circuit challenging the November 6, 2014, decision of the U.S. Environmental Protection Agency (EPA) to allow the continued use of tetrachlovinphos (TCVP) in flea control products used on pets. NRDC’s 2009 petition sought to cancel all pet uses of TCVP based on alleged potential health risks to children.
In February 2014, NRDC filed a petition for a writ of mandamus in the United States Court of Appeals for the District of Columbia Circuit seeking the court to compel EPA to respond to NRDC’s petitions to cancel all manufacturer registrations and uses of propoxur and TCVP, which are used in pet flea treatment products. Sergeant’s Pet Care Products, Inc., Wellmark International, and Hartz were among flea collar brands at issue.
In March 2014, EPA announced an agreement with Sergeant’s Pet Care Products, Inc. and Wellmark International, whereby the companies voluntarily cancelled the use of propoxur in flea collars. Related uses of other chemicals, including TCVP in pet collars, were not addressed in that agreement, and EPA denied, in November 2014, NRDC’s 2009 petition seeking to cancel all pet uses of TCVP.
NRDC first petitioned EPA to cancel propoxur uses in pet collars in 2007. NRDC filed a petition in April 2009 to cancel all pet uses of TCVP based on its Poison on Pets II report, which asserted that unsafe levels of pesticide residues are present on dogs and cats after a flea collar is used.
EPA conducted a risk assessment of multiple pet use products (e.g., shampoos, dips, powders, and flea collars) containing TCVP in 2006 during the reregistration process. The majority of the uses were assessed using registrant-submitted chemical-specific data. Potential post-application assessments for the majority of the uses included assessing dermal contact with the treated animal (e.g., a child hugging a dog) and hand-to-mouth contact by a toddler following contact with treated animals (e.g., touching the dog and then putting their hand in their mouth). These were considered to be worst-case assessments based on the amount of dermal and hand-to-mouth contact used by EPA. Potential post-application exposure to adults and children were not assessed for flea collars. In the case of flea collars, EPA concluded: “Post application exposure to residues from pet collars is considered to be insignificant when compared with exposure to other products. Because other, higher exposure uses were not of concern, an assessment for collars was not conducted.”
This last sentence is especially important, as EPA is likely to reiterate this conclusion, whether curtly or in detail, as its direct response to the petition. As this is a fairly predictable Agency response, NRDC appears to want this petition to signal its continuing concerns about organophosphate use generally, and be able to raise concerns about “children’s risks” in particular.
The case concerned the non-governmental organizations’ (NGO), the Plaintiffs, interest in having the European Commission review Regulation (EC) 149/2008 amending Regulation (EC) 396/2005 of the European Parliament and of the European Council by establishing Annexes II, III, and IV setting maximum residue levels (MRL) for pesticides in or on certain products. In a June 14, 2012, decision, the General Court found that the European Commission was erroneous when it refused the NGOs’ request to review internally its regulation and found that the EU’s Aarhus Regulation 1367/2006 (setting forth how EU institutions would apply the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters) conflicted, in part, with Article 9(3) of the Convention in that it too narrowly limited the concept of an “administrative act” and the ability of the public to have access to administrative or judicial procedures to challenge acts by public authorities that contravene provisions of national law related to the environment. The European Commission and the European Council appealed the General Court’s decision, arguing in part that the Aarhus Regulation was not incompatible with the Aarhus Convention. In the January 13, 2015, decision, the Court of Justice agreed with the European Commission and the European Council, stating: “It follows from paragraph 47 of this judgment that Article 9(3) of the Aarhus Convention lacks the clarity and precision required for that provision to be properly relied on before the EU judicature for the purposes of assessing the legality of Article 10(1) of Regulation No 1367/2006.” This decision will have an impact on NGOs’ rights to seek review of EU environmental acts and, potentially, other pending cases brought by NGOs invoking rights under the Aarhus Regulations.
On January 21, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is registering a new insecticide, flupyradifurone, which EPA claims is “safer for bees” and will be “an alternative to more toxic products including pyrethroid, neonicotinoid, organophosphate and avermectin insecticides.” EPA has been under increasing pressure to take action to mitigate a decline in the viability of honeybee colonies known as colony collapse disorder or CCD. The neonicotinoid class of insecticides has been a subject of particular regulatory scrutiny, based on assertions that pesticides in this group are particularly toxic to pollinators. EPA has been reluctant to single out pesticide use as the dominant cause of CCD, and has suggested that habitat loss, infections with the varoa mite, and exposure to other pathogens are likely to be contributing factors as well.
In early 2013, the European Food Safety Authority released a risk assessment indicating that three neonicotinoids, clothianidin, imidacloprid, and thiamethoxam, pose an acute risk to pollinators, which led subsequently to a two-year suspension of the registrations for these three neonicotinoids in the European Union. Later that year, EPA informed registrants that it would require new labeling for neonicotinoids to mitigate risks to pollinators. In June 2014, President Obama issued a memorandum creating a federal task force to promote the health of honeybees and other pollinators, and directed EPA to assess the effects of pesticides, “including neonicotinoids,” on pollinator health.
Neonicotinoids have become more popular in large measure because of restrictions on organophosphate use that were intended to protect applicators and to reduce potential dietary risks from treated commodities. Although EPA has not expressly determined its view regarding how much neonicotinoids are contributing to CCD, EPA has been under pressure to take decisive action to address the risk to pollinators. By characterizing a newly registered insecticide primarily in terms of the risk that it poses to bees, EPA appears to be suggesting that alternatives to the neonicotinoids will become an important part of the regulatory response to CCD.
EPA Announces New Draft Guidance on Reducing Use of Lab Animals and Increasing Relevant Acute Toxicity Data on Pesticides
On January 9, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it released a new draft guidance document in its effort to help expand the acceptance of alternative methods for acute toxicity testing. EPA states that the rapid advances in science and continual development of new technologies, it recognizes there is an increasing potential for the use of alternative methods in regulatory risk assessments.
EPA’s goals for alternative testing approaches include:
* Assessing a broader range and potentially more human-relevant adverse effects;
* Generating and reviewing data more quickly and less expensively; and
* Reducing use of laboratory animals in regulatory testing.
The draft guidance, Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies, describes the process for evaluating and implementing alternative methods of testing for acute oral, dermal, and inhalation toxicity, along with skin and eye irritation and skin sensitization. Additionally, there is a discussion of the three major phases of the process, and the implications for reporting information under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2). Successfully putting this process into place will require an open dialogue with stakeholders, other regulatory organizations, and the scientific community.
This draft guidance is one step in the application of OPP’s strategic vision for implementing the 2007 National Research Council report on Toxicity Testing in the 21st Century.
EPA's Recently Released Revised Human Health Risk Assessment for Chlorpyrifos Reflects New Implementation of EPA Policy
The U.S. Environmental Protection Agency’s (EPA) January 5, 2015, release for public comment of the revised human health risk assessment of chlorpyrifos (http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2008-0850-0195) reflects another step taken to implement its new spray drift and volatilization policies. These policies were long in the making and the subject of significant discussion and controversy over the years. EPA, with this assessment, has also taken a very public step to implement its controversial policy, announced in December 2009, to apply, effectively, Food Quality Protection Act (FQPA) risk assessment techniques to pesticide uses not subject to FQPA, as part of its commitment to environmental justice.
The spray drift and volatilization policies were discussed in an October 2014 webinar and discussed in our September 17, 2014, memorandum. EPA’s Revised Risk Assessment Methods for Workers, Children of Workers in Agricultural Fields, and Pesticides with No Food Uses, issued in 2009, is discussed in our December 8, 2009, memorandum.
Spray Drift and Volatilization
EPA had been assessing spray drift and volatilization for chlorpyrifos for a number of years, and many of the EPA-derived spray drift and volatilization tools are based on chlorpyrifos data. The January 5 assessment updates the assessment conducted in 2011. This document assesses both potential risks to workers (mixing/loading/applying and re-entry) as well as potential risks to residents (bystanders and food/water consumption). The bystander assessment uses the new tools that EPA released in Spring 2014 to assess potential risks from volatilization and spray drift (as discussed in the B&C webinar). The buffer zones EPA had previously estimated to mitigate spray drift are reduced in the new assessment. The risks noted in the assessment were for workers and specific water areas.
FQPA Risk Assessment Methods Use for Non-FQPA Assessment
In addition to implementing its spray drift and volatilization policies, EPA also assessed exposure in a manner that appears intended to implement the 2009 policy that was the subject of much concern when released for public comment. In that policy, EPA stated its intent to apply risk assessment techniques developed in implementing FQPA’s “extra safety factor” to any pesticide product’s risk assessment, regardless of whether it falls under FQPA, “so long as application of the risk assessment technique is consistent with good scientific practice and is not otherwise prohibited by law.” EPA stated then that this would include “using an additional safety/uncertainty factor to protect children,” as well a number of other factors. EPA announced this policy originally as part of its commitment to considerations of environmental justice.
The chlorpyrifos assessment is based on a physiologically-based, pharmacokinetic-pharmacodynamic (PBPK-PD) model to estimate the toxicologic Points of Departure (POD), thus deriving different toxicological values of concern based on the age, sex, and duration of exposure. The PBPK-PD model is also used to estimate intra-species uncertainty factors (UF), as there is no need for inter-species factors because the model estimates human red blood cell (RBC) acetylcholinesterase/cholinesterase (AChE/ChE) inhibition. Based on the PBPK-PD model, a 10X intra-species factor was used for females of childbearing years whereas it was 4X for all other groups assessed.
The worker of concern in the assessment is defined to be a female of childbearing years due to concern of not only RBC AChE/ChE inhibition, but also the potential for neurodevelopmental effects as seen in epidemiological studies. The epidemiological studies are controversial because there have been many questions about actual exposure to chlorpyrifos, particularly as two studies measured a biomarker that can be seen from exposure to other organophosphates (OP). The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Science Advisory Panel (SAP) reviewed EPA’s assessments of these studies in 2008 and 2012. The SAP concluded that “chlorpyrifos likely played a role” in the observed neurodevelopmental outcomes. EPA determined that based on the weight of evidence (WOE) from animal studies and epidemiological studies, reduction of the 10x “FQPA Safety Factor (SF)” was not appropriate. The residential dietary assessments were compared to a Margin of Exposure (MOE) of 100 (10X FQPA SF x 10X intra-species factor) for women and an MOE of 40 (10X FQPA SF x 4X intra-species factor) for all other ages. The occupational assessments were compared to an MOE of 100 for women and 40 for all other age groups (with no explanation of the reasoning behind those values).
This is noteworthy and should be examined closely because EPA has effectively used an additional “FQPA factor” as a safety factor for occupational assessments. EPA stated in its press release announcing the assessment that potential restrictions may be necessary to protect workers and water.
There is a 60-day comment period for this document, which are due on or before March 16, 2015. Among the issues commenters are likely to address include:
Use of the PBPK-PD model to estimate PODs;
Use of the PBPK-PD model to estimate intra-species uncertainty factors;
Use of the epidemiological data; and
Use of a 10X SF for occupational exposure.
The full impact of this assessment is not yet clear, but it raises many issues of interest to registrants.
On December 19, 2014, the U.S. Environmental Protection Agency (EPA) announced it is preparing in final the regulations on pesticide export labeling. The new proposed rule corrects the inadvertent removal of a provision that occurred in the January 2013 revisions to these regulations. EPA is restoring the provision that allows information required under the regulations to be placed on collateral labeling (such as bulletins, leaflets, circulars, brochures, data sheets, or flyers) attached to a shipping container of pesticide products rather than on the immediate package of each individual product in the shipment.
Producers of pesticide products and devices intended solely for export will meet EPA’s labeling requirements by attaching a label to the immediate product container, or by providing collateral labeling that is either attached to the immediate product being exported or that accompanies the shipping container of the product being exported at all times when it is shipped or held for shipment in the United States. Collateral labeling will ensure the availability of the required labeling information, while allowing pesticide products and devices that are intended solely for export to be labeled for use in and consistent with the applicable requirements of the importing country.
On January 18, 2013, EPA revised its export label regulations (40 C.F.R. Part 168 Subpart D) concerning the labeling of pesticide products and devices intended solely for export. The revisions were effective on March 19, 2013, with a compliance date of January 21, 2014. Industry stakeholders subsequently expressed concern to EPA that certain provisions no longer appeared in this Subpart, and the inability of registrants to use the labeling method allowed in the previous regulations could create trade barriers and increase costs. EPA agreed and on April 30, 2014, issued a direct final rule to replace the provision that was inadvertently removed. Since EPA received written adverse comment on the direct final rule, EPA withdrew that direct final rule, and issued a new proposed rule to seek public comment on the changes. EPA is now preparing the revisions in final to its export labeling regulations to replace the provision that was inadvertently removed.
The final revisions are available at www.regulations.gov, docket number EPA-HQ-OPP-2009-0607. Additional information on EPA requirements for importers and exporters is available at www2.epa.gov/importing-exporting.
On December 19, 2014, EPA opened the public comment period for 19 registration reviews. 79 Fed. Reg. 75801. The registrations are for: 3-methyl-cyclohexen-1-one (Case 6074); alkyl trimethylenediamines (ATMD) (Case 3014); boscalid (Case 7039); dikegulac sodium (Case 3061); ethoxyquin (Case 0003); fenpyroximate (Case 7432); flonicamid (Case 7436); fluazifop butyl, isomers (Case 2285); flufenpyr-ethyl (Case 7262); HHT (Grotan) (Case 3074); metolachlor & s-metolachlor (Case 0001); napthaleneacetic acid (Case 0379); oxadiazon (Case 2485); oxyfluorfen (Case 2490); pentachlorophenol (Case 2505); sodium fluoride (Case 3132); sulfonic acid salts (Case 7619); triclopyr (Case 2710); and yellow mustard seed (Case 7618). EPA will accept comments and information until February 17, 2015.
On December 16, 2014, the Center for Food Safety (CFS) and its affiliate the International Center for Technology Assessment (ICTA), along with a coalition of other non-governmental organizations, brought suit in the U.S. District Court for the District of Columbia. The suit concerns a May 1, 2008, petition by these organizations requesting that the U.S. Environmental Protection Agency (EPA) take regulatory action concerning nanoscale silver (nanosilver) products, including classifying nanosilver as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since receiving the CFS/ICTA petition, EPA has taken a number of incremental steps to regulate nanosilver. After inviting comment concerning the petition, EPA referred scientific issues concerning risks from and exposure to nanosilver to the FIFRA Scientific Advisory Panel (SAP), announced that it would treat nanoscale pesticides (including nanosilver) as a separate pesticidal active ingredient, established new registration requirements for several specific nanosilver products, and initiated the registration review process for registered nanosilver products.
Notwithstanding these actions, EPA has not formally responded to the 2008 CFS/ICTA petition, and the petitioners have characterized the steps taken by EPA to date as “toothless.” Rather than contesting the suit, EPA may seek an agreement requiring EPA to respond formally to the petition by a specified date. Perhaps EPA will characterize the regulatory actions taken to date as a partial grant of the petition. On the other hand, many of the nearly 400 nanosilver products that CFS/ICTA claim EPA should regulate under FIFRA have no pesticidal claims or purpose or are being sold and distributed outside of the U.S. With respect to these products, EPA will likely respond that it has no authority to provide the relief sought by the petitioners.