Posted on April 20, 2015 by Lisa M. Campbell
By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.
On April 15, 2015, the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), the National Oceanic and Atmospheric Administration National Marine Fisheries Service (NMFS), and the U.S. Department of Agriculture (USDA) held a one-day workshop regarding assessing risks to endangered and threatened species from pesticides. This workshop was intended to provide a forum for stakeholders to offer scientific and technical feedback on the ongoing agency efforts to develop draft Biological Evaluations (BE) for three pilot chemicals (chlorpyrifos, diazinon, and malathion) in response to the National Academy of Sciences’ (NAS) report “Assessing Risks to Endangered and Threatened Species from Pesticides.” The workshop was the fourth interagency workshop on this issue, and follows previously-held public meetings in November and December 2013, April 2014, and October 2014, and was held as part of the enhancement of the stakeholder engagement process finalized in March 2013. A copy of the Fourth ESA Stakeholder Workshop agenda is available online. The Interagency presentations are also available online.
This workshop presentations and discussion appeared to demonstrate progress among the agencies in coordinating their work to address the issues that have been the subject of this and prior workshops. The presentation content exhibited a better understanding of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) evaluation process by the Services, and the presentations themselves allowed for more interaction between the presenters and participants; some of the question and answer sessions (conducted after each segment) included detailed exchanges of information among the participants.
To the dismay of some registrants and observers, however, as the various evaluation models were described, and an avian case study presented, the direction of the joint analyses seemed to be moving towards the marriage of very conservative EPA assessment models and assumptions with the Services’ desire to avoid any potential impacts on individual members of a protected species and any habitat. Should this direction not change, the Endangered Species Act pilot assessments could be very conservative and indicate what many may believe is an unwarranted need for significant changes in some current pesticide labels. Simply put, from a registrant perspective, the good news is that the agencies are cooperating and working better together; the bad news is that both EPA and the Services appear to be planning to use very conservative models and assumptions, which could result in proposals for severe restrictions on some current use patterns.
Posted on March 25, 2015 by Heidi
By Lynn L. Bergeson and Carla N. Hutton
Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition. In general, the response does not alter EPA’s legal position with regard to nanosilver and its regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or otherwise contribute any new interpretations of existing EPA pesticide registration or enforcement policy.
Briefly, the key decisions articulated in EPA’s response to the petition are:
* EPA will treat products containing nanosilver as pesticides under FIFRA if intended for pesticidal purposes, even in the absence of explicit pesticidal claims.
* EPA rejected ICTA’s claim that all products containing nanosilver are categorically pesticides and should be regulated as such.
* EPA will continue to apply its statutory and regulatory criteria as to what is a pesticide on a case-by-case basis. The determination “would be fact specific, typically based upon information on the use patterns intended, the claims or other advertising used to distribute or sell the ingredient or product, and any other information or knowledge made known to or known by the distributor or seller.”
* Importantly, EPA disagrees with ICTA’s claim that the treated article exemption should not apply to any nanosilver pesticide product because nanosilver specifically is not the registered pesticide active ingredient. According to EPA, application of the treated article exemption is available if a registered pesticide product is used, consistent with any terms and conditions of use of the registered product.
* EPA granted ICTA’s request to review the health and safety impacts from use of a nanosilver ingredient in a pesticide product based on nanosilver data for the portion released as nanosilver and based on macro-scaled silver for the portion released as silver ions, and agrees that FIFRA Section 3(c)(7)(C) is the appropriate authority for review of applications for registration of products containing nanosilver ingredients.
* EPA rejected ICTA’s claim that EPA must comply with the National Environmental Policy Act (NEPA) to assess the environmental impacts of EPA’s decision regarding nanopesticides, citing EPA’s well-settled view that it is exempt from NEPA requirements under FIFRA under Merrell v. Thomas, 807 F.2d 776 (9th Cir. 1986).
* EPA denied ICTA’s request to use a particular enforcement strategy to address unregistered pesticides sold or distributed in the U.S., believing that EPA lacks a factual basis to conclude that all nanosilver products are pesticides and thus does not have the legal basis upon which to conclude that all products are illegally sold or distributed.
Posted on March 04, 2015 by bugadm
REMINDER
Border Security: EPA's Increased FIFRA Import Enforcement Initiative
March 12, 2015
2:00 p.m. - 3:00 p.m. (EDT)
Register online
Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1), coupled with EPA's increasing scrutiny of pesticide imports, indicate that this is an issue of growing interest to EPA and could result in a rise of enforcement cases or, at a minimum, business disruption for shipments that are refused entry.
This webinar will highlight recent developments and suggest steps importers should take to ensure compliance and avoid potential enforcement. There will be 45 minutes of presentation, followed by a 15 minute Q&A period.
Topics will include:
* Requirements for importation of registered and unregistered pesticides
* Revised NOA "recommendations" and "optional" sections -- what they really mean
* EPA's recent enforcement priority on pesticide importations and examples of EPA and U.S. Customs detentions of imported pesticides
* Industry perspective and steps to avoid non-compliance
Speakers:
* Eileen B. Salathé Gernhard, Lead Counsel, Regulatory and EH&S at Dow AgroSciences, LLC
* Lisa M. Campbell, Partner, B&C
* Lisa R. Burchi, Of Counsel, B&C
* Jon Jacobs, a 25-year veteran of EPA's Office of Enforcement and Compliance Assurance, now in private practice with Jacobs Stotsky PLLC
For questions regarding this webinar, please contact .(JavaScript must be enabled to view this email address).
Posted on February 17, 2015 by Lisa M. Campbell
March 12, 2015
2:00 p.m. - 3:00 p.m. (EST)
Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1), coupled with EPA's increasing scrutiny of pesticide imports, indicate that this is an issue of growing interest to EPA and could result in a rise of enforcement cases or, at a minimum, business disruption for shipments that are refused entry.
Speakers who will be highlighting recent developments and steps for importers to take to ensure compliance and avoid potential enforcement include: Eileen B. Salathé Gernhard, Lead Counsel -- Regulatory and EH&S at Dow AgroSciences, LLC, B&C's Lisa M. Campbell and Lisa R. Burchi, and attorney Jon Jacobs, a 25-year veteran of EPA's Office of Enforcement and Compliance Assurance, now in private practice at Jacobs Stotsky PLLC. There will be 45 minutes of presentation followed by a 15 minute Q&A period.
Please save the date -- registration details will follow.
Posted on February 04, 2015 by Lisa M. Campbell
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
The U.S. Environmental Protection Agency (EPA) has announced its new more “user-friendly” website for minimum risk pesticides. Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b)(2) and EPA’s implementing regulations at 40 C.F.R. § 152.25(f), pesticides meeting certain criteria (e.g., containing only specified, listed active and inert ingredients, not bearing public health claims) are determined by EPA to pose little to no risk to human health or the environment and exempt from FIFRA registration requirements. EPA states the website “highlights the most-requested information and has been redesigned based on historic website traffic, with a focus on stakeholders who are interested in manufacturing, selling or distributing minimum risk pesticides.” Specifically, the website is now focused on four main areas:
* About Minimum Risk Pesticides;
* Conditions to Qualify as a Minimum Risk Pesticide Product;
* Clarifications about Minimum Risk Active and Inert Ingredients; and
* Regulation and Enforcement of Minimum Risk Pesticides.
Although the scope of application of minimum risk pesticides has been the focus of proposed regulatory changes in recent years, EPA states that this website is not intended to include any regulatory changes or new requirements. There is, however, a December 2010 rule proposing changes to the minimum risk pesticide requirements that has yet to be issued in final. It is noteworthy that EPA has highlighted and clarified its Section 25(b) policies, but has not yet issued a final rule. A memorandum regarding EPA’s proposed rule is available at http://www.lawbc.com/regulatory-developments/entry/epa-proposes-revisions-to-minimum-risk-exemption-for-pesticides/.
Instead, EPA states it has included more information to be clearer about the conditions that a product must meet to be considered minimum risk. Any clarifications of the applicable requirements could be helpful for manufacturers that are responsible for ensuring compliance at the federal level for minimum risk pesticides since EPA does not review or approve such registrations. It is important to note that minimum risk pesticides exempt from EPA registration are still frequently subject to registration requirements at the state level, and state regulators perennially identify non-compliance by products asserting eligibility for minimum risk status. Any outreach that makes the eligibility and compliance requirements clearer should assist companies in navigating both federal and state requirements.
The address for the new website is www2.epa.gov/minimum-risk-pesticides.
Posted on January 08, 2015 by Lisa M. Campbell
By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.
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.
Next Steps
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.
Posted on August 15, 2014 by bugadm
By Timothy D. Backstrom
In a wide-ranging decision issued on August 13, 2014, in Center for Biological Diversity v. EPA (N.D. Cal.) (often referred to as the “Mega ESA” case), Magistrate Judge Spero has dismissed most of the claims by the Plaintiffs that the U.S. Environmental Protection Agency (EPA) failed to consult or to reinitiate consultation under Endangered Species Act (ESA) Section 7(a)(2) in connection with EPA’s registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of a variety of pesticides. This decision is significant not only for its findings concerning judicial review of consultations under the ESA, but also for the potential effect on challenges to generic reregistration decisions, and on individual product actions based on those EPA decisions. Registrants should carefully consider the impact of this decision on potential challenges to EPA actions involving their products. A copy of the decision is available online.
The ESA claims that were dismissed fall in three principal categories: (1) claims concerning Reregistration Eligibility Decisions (RED) for which the general six-year statute of limitations has expired; (2) claims concerning REDs that are reviewable only in the Court of Appeals under FIFRA Section 16(b) and that were not brought in that court within the applicable 60-day period; and (3) claims based solely on Plaintiffs’ allegations that EPA retains ongoing discretionary control over pesticide registration. Claims by the Plaintiffs that currently survive this decision, at least pending further submissions by the Parties, include claims concerning EPA’s reregistration of specific pesticide products, and claims concerning EPA’s failure to reinitiate consultation for any pesticidal active ingredients that were subject to prior Biological Opinions issued by the Fish and Wildlife Service (FWS) for which the process of reregistration is not yet complete.
Posted on July 09, 2014 by Lisa M. Campbell
By Lisa M. Campbell
On July 7, 2014, the Natural Resources Defense Council (NRDC) filed with the U.S. Environmental Protection Agency (EPA) a petition requesting that EPA commence a Special Review for the neonicotinoid pesticides, including six specific active ingredients (dinotefuran, acetamiprid, clothianidin, thiacloprid, imidacloprid, and thiamethoxam), based on the risk that NRDC believes this class of compounds poses to honey bees and native bees. In the petition, NRDC alleges that neonicotinoids “may suppress bee immunity, disrupt brood cycles, impair foraging behavior by interfering with memory and learning, and cause disorientation, preventing bees from finding their way back to the hive.” By submitting this petition, NRDC effectively asks that EPA expedite the evaluation of the effect of this class of active ingredients on pollinators that EPA already intends to undertake as part of the Registration Review process required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(g), 7 U.S.C. § 136a(g). A copy of the petition is available online.
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