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.
NAFTA TWG on Pesticides Meeting
On November 3-5, 2015, the North American Free Trade Agreement (NAFTA) Technical Working Group (TWG) on Pesticides, established in 1997 to streamline certain pesticide shipments between Canada (CN), Mexico (MX), and the United States (U.S.), held a meeting hosted by the U.S. Environmental Protection Agency in Durham, North Carolina. NAFTA TWG states that its primary objective “is to develop relevant and cost-effective pesticide regulation and trade among the three countries and meet the environmental, ecological, and human health objectives of NAFTA.” Further, TWG partners address trade issues, national regulatory and scientific capacity, governmental review burden, and coordination of regulatory decision making and industry burden reduction.
The topics discussed at its November meeting, a government-stakeholder meeting with the Executive Board, regulatory officials, and interested stakeholders such as growers, industry, and public interest groups, were:
Five-Year Strategic Plan and NAFTA Industry Working Group (IWG) Updates. The presentation was as follows:
Science and Policy Initiatives:
MX’s input regarding “US EPA Guidance for Assessing Pesticide Risks to Bees” (Lead: MX -
SEMARNAT or SENASICA);
“Joint Minor Use Updates” (Leads: U.S. - Susan Lewis and CN - Margherita Conti); and
Stakeholder Presentations and Discussions:
The presentations, many of which address issues of significant controversy and debate, are of interest to many in industry and to other stakeholders.
On October 30, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on a proposal to revoke all tolerances for the insecticide chlorpyrifos. EPA issued this proposal in response to an August 10, 2015, writ of mandamus by the U.S. Court of Appeals for the Ninth Circuit. The court granted this unusual relief in response to a 2007 administrative petition to cancel chlorpyrifos registrations or to revoke chlorpyrifos tolerances by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (together, Petitioners). The court’s August 10, 2015, order required that EPA do one of the following by October 31, 2015: (a) cancel the registrations of all pesticides containing chlorpyrifos; (b) issue a proposed or final rule to revoke chlorpyrifos tolerances; or (c) issue a full and final response to the administrative petition to cancel chlorpyrifos. More information on that decision is available in our blog item Circuit Court Grants Writ of Mandamus Requiring EPA to Act on Petition to Ban Chlorpyrifos.
In its announcement, EPA states that it “is not denying the petition because we are unable to make a safety finding based on the science as it stands currently. EPA is not issuing a final revocation rule because we have not proposed it and have not completed our refined drinking water assessment, leaving certain science issues unresolved.” The court also required EPA to provide the timeline for a final rule should EPA issue a proposed revocation by October 31, and EPA notified the court of an anticipated date for a final rule of December 2016. EPA will release a completed hazard assessment and a completed drinking water analysis for comment prior to issuance of any final rule.
Because EPA has not completed its hazard assessment and drinking water analysis, this means that EPA may resolve the “science issues” without the need for tolerance revocations. The proposal is based not on the risk posed by chlorpyrifos residues in food, but on the incremental risk posed by chlorpyrifos in drinking water in very specific and limited watersheds where chlorpyrifos is heavily used. EPA is required to consider such exposures in evaluating the safety of chlorpyrifos residues in food under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act (FQPA). If the tolerances are revoked, this will result in cancellation of the associated food uses of chlorpyrifos.
The chlorpyrifos registrant Dow AgroSciences and other pesticide industry representatives do not agree with the EPA analysis or the proposal to revoke the tolerances. In particular, questions have been raised about EPA’s decision to retain the use of a 10X FQPA safety factor for infants and children based on certain epidemiology studies. EPA has acknowledged that these studies have significant limitations and that they cannot identify a specific level of concern for quantitative risk assessment. EPA has previously reduced the FQPA safety factor for chlorpyrifos to one based on the completeness of the toxicological database. If the 10X FQPA safety factor were reduced to one or even to three, the results of the current risk assessment would be very different.
In a November 2, 2015, Federal Register notice, the U.S. Environmental Protection Agency (EPA) issued the final rule revising the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS). EPA previously announced these revisions on September 28, 2015, and stated that it would issue the final rule in the Federal Register within 60 days.
The following are important dates:
EPA also states that it is “committed to a robust outreach, communications and training effort to communicate the new rule requirements to affected WPS stakeholders.” EPA has stated its intent to do the following to facilitate implementation:
The details of the WPS final rule are discussed in Bergeson & Campbell, P.C.’s (B&C®) blog entry EPA Announces Revisions to Its Worker Protection Standard.
For more information, please see B&C’s memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2015 and James V. Aidala Comments on EPA’s Worker Protection Standards. More information is also available on EPA’s Worker Protection Standard webpage.
On October 23, 2015, in the U.S. Court of Appeals for the Ninth Circuit, the Natural Resources Defense Council (NRDC) and other environmental groups including the Center for Food Safety (CFS, et al.) (together, Petitioners) filed separate opening briefs in Case Nos. 14-73353 and 14-73359 (consolidated) arguing that the U.S. Environmental Protection Agency’s (EPA) decision to register Dow AgroScience’s Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on Enlist corn and soybeans should be overturned because it violates the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Endangered Species Act (ESA). EPA approved Enlist Duo for use in six states on October 15, 2014, and granted an amendment on March 31, 2015, to authorize use in an additional nine states. On August 11, 2015, the Court of Appeals denied motions for a stay pending review that were filed by these same environmental Petitioners on December 18, 2014, and February 6, 2015. See “Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review.”
In its brief, NRDC notes that when EPA proposed to register Enlist Duo, it stated that no new assessment is needed for glyphosate because use of glyphosate on herbicide-resistant crops is not a new use. NRDC argues that there are many new studies concerning glyphosate’s human health effects and impacts on monarch butterflies since EPA reregistered glyphosate and last prepared comprehensive environmental and human health assessments in 1993. NRDC argues that “By failing to consider up-to-date science on glyphosate’s cancer risk, EPA again violated its statutory duty to ensure that registration of Enlist Duo would not cause ‘unreasonable adverse effects on the environment,’ which includes an unreasonable risk to human health.”
In their brief, CFS, et al. argue that EPA violated FIFRA by ignoring its own modelling indicating that risks to wildlife from Enlist Duo exceed EPA’s risk thresholds. CFS, et al. also focus on purported violations of the ESA, arguing that EPA improperly failed to consult with the U.S. Fish and Wildlife Service on the potential impacts of Enlist Duo on protected species and their critical habitat, and that EPA applied an “unlawful approach” to determine whether registration of Enlist Duo “may affect” listed species or critical habitats.
NRDC also filed a motion to supplement the record with three documents that it states were submitted to EPA, but it contends were not considered by EPA before it issued its registration decision for Enlist Duo. The documents include an article published by the World Health Organization’s (WHO) International Agency for Research on Cancer stating that glyphosate is “probably carcinogenic to humans”; a statement published by WHO in conjunction with its cancer finding, and a letter from NRDC and other concerned parties calling on EPA to reconsider its initial decision to register Enlist Duo in light of the WHO’s cancer finding.
Petitioners’ arguments in these opening briefs are not unexpected, as pesticide products containing glyphosate have been challenged and controversial for many years. In briefs opposing the prior stay motions by the Petitioners, EPA and the registrant Dow AgroSciences argued that registration of Enlist Duo will not lead to any increase in the use of glyphosate, and that EPA also considered all of the human health effects of 2,4-D before granting the registration. The Petitioners acknowledge that EPA did not state when it last conducted environmental and human health assessments for glyphosate, and EPA is likely to object to Petitioners' inference that EPA has not reviewed the environmental and health effects of glyphosate since 1993. In the fact sheet concerning its decision to register Enlist Duo, EPA states that it conducted a “rigorous analysis” of all the scientific studies, considered all public comments, and used worst-case estimates when assessing the safety of Enlist Duo. In addition, the Petitioners do not discuss the determination by the the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS), that three varieties of herbicide resistant corn and soybeans on which Enlist Duo will be applied are no longer considered regulated articles under regulations governing the introduction of certain genetically engineered organisms, because they are unlikely to pose a plant pest risk.
EPA and Dow AgroSciences’ answering briefs are due December 18, 2015, and reply briefs are due January 15, 2016. Oral argument has not yet been scheduled.
EPA’s OCSPP Agrees to More Communication, Transparency, and Efficiency When Processing Pesticide Petitions
On October 27, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs Policies and Procedures to Manage Public Pesticide Petitions in a Transparent and Efficient Manner” (OIG Report). OIG evaluated how EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) tracks the receipt, disposition and resolution of public petitions, focusing on OCSPP’s Office of Pesticide Programs (OPP) and its policies and procedures used to ensure consistency and transparency when responding to pesticide-related public petitions. Although pesticide petitions can be submitted to EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), the Administrative Procedure Act (APA), or any combination of these authorities, OIG’s “At a Glance,” a document summarizing the OIG Report, states that OPP “does not have policies or procedures to ensure transparency when managing public pesticide petitions.”
OIG’s Report outlines three main areas for improvement in communication, stating that OPP has not effectively communicated with petitioners in the following manner: (1) acknowledging petition receipt; (2) providing updates about the agency’s work to resolve petitions; and (3) providing petition decisions. For example, OIG noted that since FIFRA does not set forth requirements for EPA to respond to a petition within a specific timeframe, petitioners in many circumstances filed lawsuits claiming EPA had not responded within a reasonable amount of time as required under the APA.
In addition, OIG states that OPP lacks policies and procedures to manage petitions in a generally efficient or effective manner, specifically noting: (1) petition documentation is not readily accessible, which was inconsistent with each of the EPA’s Records Management Policies in place during the timeframe of OIG’s review; (2) some petition data are inaccurate, which results in the duplication of work to confirm data; (3) according to OPP, petitions may take weeks to arrive at the correct office for action, because there is no guidance on how to submit petitions directly to OPP; and (4) OPP does not provide guidance to the public on how to submit complete petitions, which results in some petitioners providing supplemental information, therefore increasing the time and resources to reach petition decisions.
The report makes four recommendations of actions that should be taken by the Assistant Administrator for OCSPP that OIG believes will address the issues. In a memorandum attached to the OIG report, OCSPP agreed with these recommendations, provided corrective actions, and estimated completion dates. OIG’s recommendations and OCSPP’s Corrective Actions in response to them are as follows:
Recommendation 1: Develop policies and standard operating procedures to manage public petitions received by OPP in a transparent and efficient manner, which includes direct communication with petitioners by:
Corrective Action 1: OCSPP’s OPP will develop appropriate policies and standard operating procedures (SOP) to manage public petitions received by OPP in a transparent and efficient manner. The procedures will include the direct communication protocols listed in the OIG’s recommendation. Estimated date of completion: October 2016.
Recommendation 2: Train staff managing public pesticide petitions to adhere to the EPA’s Records Management Policy.
Corrective Action 2: The SOPs described in Corrective Action 1 will address maintaining appropriate records for covered petitions. When the SOP is final, OPP will issue a memorandum informing appropriate staff and management of their responsibilities for maintaining these records, and directing the use of the SOPs to meet their responsibilities under the Agency’s Records Management Policy. Estimated date of completion: November 2016.
Recommendation 3: Develop and implement an effective petition tracking system for public pesticide petitions.
Corrective Action 3: The SOPs described in Corrective Action 1 will include procedures for tracking petitions not covered by certain regulations, including petitions seeking FIFRA and APA rulemaking or cancellation of registrations. Estimated date of completion: October 2016.
Recommendation 4: Provide criteria and guidelines for submission of public pesticide petitions that provide sufficient information for EPA review.
Corrective Action 4: OCSPP commits to develop and post to the Agency Pesticides website criteria and guidelines for public submission of pesticide petitions not covered by 40 CFR § 180.7. Estimated date of completion: October 2017.
Petitions under FIFRA have been a relatively obscure tool in the past because of some of the issues this report seeks to address. With no deadline for a response, some petition responses have languished for many years (reportedly up to seven years in some cases). This partly becomes a “chicken and egg problem;” since it was not clear if and when a response would be forthcoming, it was a relatively unused tool. Indeed, as OIG’s report points out, only 40 pesticide petitions were submitted between FY2005 and 2014, with almost half (17) still pending.
In recent years, the Obama Administration has made it a point to respond more timely to FIFRA petitions, and as a result, petition filings may have become more attractive to various stakeholders. One practice that has been a vulnerability for OPP in the past is that not responding whatsoever would more likely lead to a successful “unreasonable delay” suit. OSCPP’s agreement with the OIG Report recommendations to more clearly state rules of engagement and how to frame expectations about a petition response process appears to be a continuation of the emphasis of EPA leadership on responding to petitions in a timely and more predictable manner.
Like so many other regulatory programs in China, pesticide regulations are changing. At the 8th China High-Level Forum on Pesticides, Ying Ji, Chief Agronomist of the Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA), stated that the future of pesticide regulation in China will see more emphasis placed on industrial development, registration security, the application of more risk assessment techniques, and will focus more on reducing the burden of procuring registrations for minor use crops. In China, the vast majority of registrations are for major crops and only a few registrations have been issued for minor crops. The Ministry of Agriculture also intends to prepare a "List of Pests and Pesticide Shortage for Minor Crops.”
Public Meeting Announced To Discuss Modernizing the Regulatory System For Biotechnology Products Memorandum
On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA), announced in the Federal Register a public meeting to be held on October 30, 2015, to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Framework).
The meeting is intended to discuss FDA’s role in responding to the July 2015 memorandum issued by the OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled “Modernizing the Regulatory System for Biotechnology Products,” and will invite oral comments from interested parties. The July 2015 memorandum and the October 6, 2015, OSTP-issued Request for Information (RFI) to solicit relevant data and information to update the Framework are discussed in our memorandum Biotechnology: OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology.
The Executive Office memorandum directs FDA, EPA, and USDA -- the three agencies responsible for regulating biotechnology products -- to:
This meeting is another important step in the process to update the Framework, first issued in 1986 and last updated in 1992, to reflect better promising technologies routinely entering the market and, as the July 2015 memorandum provides, “to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.” Companies with biotechnology interests should monitor and participate in this process as appropriate, given its potential impact on the industry.
The meeting will be held on October 30, 2015, from 9:30 a.m. to 1:00 p.m. (EDT) at FDA’s White Oak Campus, Building 31 Conference Center, the Great Room, 10903 New Hampshire Avenue, Silver Spring, Maryland. Registering early is recommended due to limited space. The deadline for written comments is November 13, 2015.
The U.S. Environmental Protection Agency (EPA) has launched a new pesticides website: http://www2.epa.gov/pesticides, and a new biopesticides website: http://www2.epa.gov/pesticides/biopesticides, among others. EPA states that this gradual move to new versions of its content is part of a larger EPA effort to build a more user-friendly website.
The updated biopesticides website focuses on providing general information on biopesticides, as well as tools to assist applicants for registration, and is organized into the following areas:
With this transition, web page addresses will be different which may cause links and bookmarks to break. EPA states that it is working to fix any broken links. The majority of the old pesticide pages will redirect to the new web areas, but bookmarks will still need to be updated. EPA’s new “Page Not Found” notification will help website users find what they are looking for by providing suggested search terms, links to the A-Z index, and other helpful links. The search feature available on every EPA web page and in the archive (archive.epa.gov) can also be useful in finding content.
Other updated pesticide related links are:
On September 28, 2015, the U.S. Environmental Protection Agency (EPA) announced revisions to its worker protection standard. EPA states that these revisions are intended to “enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective equipment, and the providing of supplies for routine washing and emergency decontamination.”
Among the changes to the WPS are the following:
EPA received a significant number of comments on the proposed rule, which has generated significant controversy. While it appears that EPA has modified the final WPS in certain respects in response to concerns raised, there remain many provisions that are controversial and will require significant work, with significant costs, by agricultural and handler employees to meet.
Controversy regarding these new requirements is longstanding. At its most simple form, critics of increasing the stringency of the current regulations ask why significant changes were needed after twenty years of greater protection offered by the existing regulatory requirements. In addition, over the intervening years, for a variety of reasons, many (not all) of the most hazardous pesticides have been removed from the market or otherwise are used less. More complex concerns address potential jurisdictional overreaches and the paltry record supporting what some view as expansive and expensive regulatory requirements. Others, not surprisingly, cite the number of reported (and unreported) incidents as proof for the need nonetheless to improve the extent and effectiveness of the current regulations. What EPA has issued here as the final revisions to the regulations attempts to balance these views.
Some believe that, in similar situations, where industry and activist groups criticize an action, albeit for very different reasons, the EPA action at issue must have struck the correct balance of disparate views. This breezy measure of success in an important health protection program such as this rule addresses by definition is not likely to satisfy either perspective, and complaints about the new requirements can be expected to continue, especially about the economic impact of the new requirements for some, and for others, how the occupational risks of pesticides remain too high and deserve even greater restrictions.
Outside the boundaries of the worker protection regulations, some of the underlying logic and regulation of the updated requirements indicate that EPA, at least under the current Administration, will continue its emphasis on the broader goals of environmental justice and protecting “children” from the hazards of pesticide exposure. (For example, among the most controversial elements of the changes is the prohibition on certain activities for those under the age of 18, while beforehand the cutoff age was 16; this seems partly a result of EPA’s attempt to make its policy of prohibiting testing of pesticides on children consistent with its policy of who might be exposed in occupational settings.)
The final rule will become effective 60 days after it is published in the Federal Register, but agricultural employers and handler employers will not be required to comply with most of the new requirements in the final rule until 14 months after the effective date.
For more information, please see Bergeson & Campbell, P.C.’s (B&C®) memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2015 and James V. Aidala Comments on EPA’s Worker Protection Standards. More information is also available on EPA’s Worker Protection Standard webpage.
On September 22, 2105, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register listing its revised registration service fees applicable to specified pesticide applications and tolerance actions for fiscal year (FY) 2016 that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
The Pesticide Registration Improvement Act of 2003 (PRIA) established FIFRA Section 33, creating a registration fee-for-service system for certain types of pesticide applications, establishment of tolerances, and certain other regulatory decisions under FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a schedule of decision review times for applications covered by the service fee system. EPA began administering the registration service fee system for covered applications received on or after March 23, 2004.
PRIA has been reauthorized twice, most recently by the Pesticide Registration Improvement Extension Act (PRIA 3) signed on September 28, 2012. PRIA 3 revised FIFRA section 33, reauthorized the service fee system through fiscal year 2017, and established fees and review times for applications received during fiscal years 2013 through 2017. The registration fees for covered pesticide registration applications received on or after October 1, 2015, increase by five percent from the fees published for fiscal year 2015 in the Federal Register notice issued September 26, 2013, Pesticides; Revised Fee Schedule for Registration Applications. The new fees became effective on October 1, 2015.
The notice retains the format of prior PRIA tables; it identifies the registration service fees and decision times and is organized according to the three Office of Pesticide Programs (OPP) registration divisions within EPA, with the additional sections for inert ingredients and other actions added as part of PRIA 3. Thereafter, the categories within main sections of the table are further organized according to the type of application being submitted, including new active ingredients, new uses, new products, and registration amendments There are 189 categories of activities spread across the three OPP divisions: Registration Division (63 categories), Antimicrobial Division (39 categories), and Biopesticides and Pollution Prevention Division (69 categories), plus ten inert ingredient and eight miscellaneous categories. Each has its own decision review time and service fee for FY 2016-2017. The scale of the fees differs between the three registration divisions. We note that not all submissions are subject to PRIA 3; generally speaking, any submission requiring data review will be subject to PRIA 3.
The notice also provides information on how to pay fees, how to submit applications, and the addresses for applications.
More information on the registration fees is available on EPA’s webpage FY 2016/17 Fee Schedule for Registration Applications.
Ninth Circuit Vacates EPA’s Unconditional Registration for the Neonicotinoid Pesticide Sulfoxaflor Based on Hazard to Bees
In an opinion issued on September 10, 2015, the U.S. Court of Appeals for the Ninth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) unconditional registration for the pesticide sulfoxaflor and remanded the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies. Sulfoxaflor is a new insecticide in the class of insecticides referred to as neonicotinoids, but its mechanism of action is distinct from other neonicotinoids. The Petitioners in this case were various trade organizations representing commercial beekeepers, as well as some individual beekeepers. The registrant Dow AgroSciences LLC (Dow) intervened in the action.
EPA granted an unconditional registration for sulfoxaflor on May 6, 2013, subject to a variety of risk mitigation measures, including a lower application rate, longer intervals between applications, and certain crop-specific label restrictions. EPA had previously proposed to issue a conditional registration for sulfoxaflor in January 2013, citing pollinator data gaps that could be addressed by requiring Dow to conduct and submit further studies. Under that proposal, use of sulfoxaflor would have been allowed at a reduced application rate during the time needed to complete data development. The court found that the subsequent decision by EPA to register unconditionally sulfoxaflor was not supported by substantial evidence, as required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 16(b), both because EPA failed to adhere to its own scientific methodology and because the rationale that EPA provided for granting an unconditional registration could not be reconciled with the analysis upon which EPA based its prior proposal to register conditionally sulfoxaflor.
EPA evaluated the potential risk to bees and bee colonies from sulfoxaflor use utilizing the Pollinator Risk Assessment Framework, a scientific risk assessment methodology developed after consultations between EPA, Canada’s Pest Management Regulatory Agency, and the State of California, and presented by EPA to the FIFRA Scientific Advisory Panel in 2012. The court found that the rationale provided for EPA’s unconditional registration decision could not be reconciled with findings that EPA itself made using this methodology or with the rationale EPA provided for its prior proposal to issue a conditional registration. EPA had decided it was necessary to proceed to Tier 2 of the pollinator risk assessment after reviewing risk quotients and residue data in Tier 1 of the assessment. EPA found the available data for Tier 2 to be insufficient to allow indefinite use of sulfoxaflor, even at a reduced application rate. The court could not reconcile this finding with the subsequent decision to grant an unconditional registration, even with the specified mitigation measures. The court found that “given the precariousness of bee populations, leaving the EPA’s registration of sulfoxaflor in place risks more potential environmental harm than vacating it.” The court stated that “EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA.”
EPA argued that with a reduced application rate, the risk quotients and residue analysis in Tier 1 was “close enough” to sufficient to avoid the specified quantitative trigger for a Tier 2 analysis, thereby rendering any deficiencies in the available Tier 2 data irrelevant. The court effectively stated in response that close enough is not good enough, citing another recent Ninth Circuit decision in which a risk concern that is triggered by a margin of exposure less than or equal to 1000 was held to be triggered when the margin was exactly 1000. Thus, this court once again placed EPA on notice that it must follow its own methodology with precision, and that EPA cannot justify deviations from its own methodology by simply stating that it is exercising expert judgment.
This is an unusual case because the registration of a new pesticidal active ingredient has been vacated on substantive as opposed to procedural grounds. The court’s rationale reflects a lack of judicial deference to what EPA typically refers to as the scientific “weight of the evidence.” While the term itself does not appear in the opinion, the court is insisting that EPA must follow its standard methodology without allowing for any deviations based on professional judgment. Although in this instance the court has supported the position of opponents of pesticide use, judicial reluctance to accept scientific “weight of the evidence” conclusions could also make it harder for EPA to impose additional restrictions when new but inconclusive evidence appears.
This case could cause EPA to be more explicit in adding procedures to its standard analytic methodologies that allow deviations from the methodology based on professional judgment. The case could also cause EPA to reconsider its recent reluctance to avoid issuing conditional registrations and its preference for unconditional registrations for new active ingredients. In any case, decisions that afford EPA less discretion to use “weight of the evidence” reasoning when basing scientific conclusions on less than conclusive data or studies could have an impact on a number of EPA practices and policies involving interpretation of scientific data.
On September 8, 2015, the Environmental Protection Agency (EPA) announced that it will host a Disinfection Hierarchy Stakeholder Workshop and corresponding webinar on October 7, 2015, from 8:30 a.m. - 5:00 p.m. (EDT). The “disinfection hierarchy” describes the descending order of susceptibility of classes of microorganisms to antimicrobial chemicals. Demonstrated efficacy against a representative organism would support a manufacturer’s claims against more susceptible (easier to kill) organisms, potentially eliminating the need to test against, or alternatively, to submit data for each individual organism. EPA has relied on the disinfection hierarchy concept historically. For example, EPA relied on the disinfection hierarchy concept to take timely action to address the H1N1 virus in 2009, by allowing reliance on Influenza A data. More recently, EPA states that it agreed that use of a registered hospital disinfectant with a label claim for use against a non-enveloped virus was appropriate for disinfection of surfaces contaminated with the ebola virus.
EPA is considering expanding its use of disinfection hierarchy concepts for the registration of public health antimicrobial pesticides. EPA states that its goals for expanding the use of these concepts are:
According to the announcement, the workshop will focus on the scientific merits of the hierarchy, and will provide a forum for stakeholders to discuss:
A panel of approximately 15 stakeholders from the public sector, academia, and industry will address a series of charge questions, followed by the opportunity for audience questions or comments. The current list of panel members is available here.
EPA’s Office of Pesticide Programs has developed a draft white paper on disinfection hierarchy concepts that will serve as the basis for discussion during the workshop. The draft white paper includes questions on which EPA states it is seeking input. The agenda for the workshop is available here.
More information on disinfection hierarchy is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum Summary of Ninth Antimicrobial Workshop.
On September 2, 2015, the European Chemicals Agency (ECHA) issued an updated list of biocide suppliers as required under Article 95 of the Biocidal Product Regulation (BPR). Although prior versions of the list were released previously, this list has current legal effect since Article 95 provides that, as of September 1, 2015, a biocidal product cannot be made available in European Union (EU) markets unless the active ingredient supplier or product supplier is listed for the particular product type (PT) (e.g., PT 5 (Drinking water), PT 19 (Repellents and attractants)) to which the biocide product belongs.
The purpose of Article 95 in creating a list of persons placing active substances in the EU market is to ensure the equal treatment of persons placing active substances on the market and to avoid “free riders.” Without the requirements in Article 95, a supplier of an active substance that has not supported the approval of that substance (either through the Review Programme of the biocide directive, or as a newcomer under the BPR) could still enter the market without compensating the entity that undertook the costs and effort to have the active substance listed.
There will be continued updates and revisions made to the list as new suppliers seek inclusion. In addition, ECHA states that it received 158 applications from suppliers seeking inclusion on the list, and has created a list of pending applications that ECHA is still processing. ECHA notes: “The list of pending Article 95(1) applications should not be confused with the list of relevant substances and suppliers (“Article 95 list”) and the presence of a company (per substance/PT/role) on the list of pending applications does not guarantee that the application will be successful and that the company will ultimately be included in the Article 95 list.” Updates to the list also are expected for certain substances that were not within the scope of the Biocidal Products Directive (BPD) (e.g., some in situ generated active substances, substances benefiting from derogation for food and feed in Regulation 1451/2007), and for which different BPR notification and inclusion dates apply.
Although enforcement efforts regarding the Article 95 list have not yet been tested, companies placing biocidal products in EU markets must carefully review the list to ensure that they and/or their suppliers are listed not only for the particular active ingredient and/or product at issue, but also for the product’s particular PT.
There is a one year period, until September 1, 2016, to sell existing stocks for biocide products where the suppliers are not included on the List.
On September 1, 2015, the U.S. Environmental Protection Agency (EPA) announced the debut of a new electronic system for pesticide applications, the Pesticide Submission Portal. According to EPA, this debut is the first step in a phased approach that ultimately will allow EPA to accept all pesticide applications electronically -- a move that will help modernize the pesticide registration process, increase operational efficiencies, and reduce paper waste. EPA will continue to accept paper, CD and DVD applications, but encourages applicants to take advantage of what EPA states is the new, more efficient option.
The following types of applications will now be accepted through the Pesticide Submission Portal:
The Portal is accessed through EPA’s Central Data Exchange (CDX) Network and requires user registration. For registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own builder tools using EPA’s XML guidance, they may use the Portal and forego the courier costs to send to EPA.
For electronic submissions, applicants do not need to submit multiple copies of any pieces of their application, as the requirement for multiple copies of data and five copies of draft labeling only applies to paper submissions. Additional benefits of using the Portal include a status indicator that allows registrants to track the movement of their submissions and automatically generated MRID numbers.
Additional information on the Portal, including a user guide and updated XML guidance, is available on EPA’s Electronic Submission for Pesticide Applications page.
Applicants will need to invest some time and resources up-front to register with CDX and become familiar with the electronic submission requirements. With that investment, however, EPA’s secure portal should make the submission process more efficient for applicants. Additionally, as EPA now scans all paper submissions upon receipt, electronic submissions should increase efficiencies and reduce the opportunity for error during EPA’s front-end processing -- always a good thing.
The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015. EPA’s draft framework provides guidance on how the EPA will screen groups of pesticides for cumulative evaluation. EPA proposes using a two-step approach, beginning with the evaluation of available toxicological information and, if necessary, followed by a risk-based screening approach. This framework supplements the existing guidance documents for establishing common mechanism groups (CMG) and conducting cumulative risk assessments (CRA). Additionally, EPA is also seeking comments on a draft copy of the human health risk assessment where the cumulative assessment was conducted in conjunction with pending actions for abamectin.
EPA has described a process that is data intensive and that requires sophisticated knowledge and modeling. EPA acknowledges that “the level of refinement provided by this approach is not necessary or even feasible for all existing pesticide classes.” The policy documents for conducting the first step in the process, “developing CMGs,” are still being refined.
This document provides the guidance for screening information to identify candidate CMGs and does not outline how actually to conduct CRAs. Rather, this document relies on policies and principles provided in other documents found on the EPA cumulative risk assessment website. These additional policies and principles were developed during the conduct of five CRAs for chemical groups such as the organophosphates and carbamates.
One of the major questions raised by the issuance of this document is the extent of the information that EPA will require for each chemical to determine if there are CMGs. The five CMGs currently assessed have relatively well defined mechanisms of action. It is not clear, however, what EPA will consider to be adequate justification that there are no other chemicals with the same mechanism of action for other chemicals of concern.
Requirements for EPA to determine and assess the risks of possible common mechanism of action among groups of similar pesticides was one of the most far-reaching new requirements imposed by the Food Quality Protection Act. Some observers expected a larger impact on pesticide use than what has occurred to date; whether EPA’s new approach results in more groupings or otherwise leads to restrictions on more groups of pesticides remains to be seen.
Comments on the draft guidance are due September 28, 2015. More information regarding EPA’s assessment of pesticide cumulative risk is available online.