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.
By Lynn L. Bergeson and Christopher R. Bryant
On February 10, 2015, the European Union’s (EU) chief negotiator on the Transatlantic Trade and Investment Partnership (TTIP) agreement released the EU’s initial proposal for the “legal text” of the all-important regulatory cooperation chapter. The text was tabled for discussion with the United States in the negotiating round on February 6, 2015, and released to the public shortly thereafter. The text of the final agreement will be a result of negotiations between the EU and U.S. Among the 16 “Articles” in the chapter is Article 14-Establishment of the Regulatory Cooperation Body,” or RCB, to monitor and facilitate the implementation of the provisions in the TTIP chapter on regulatory cooperation. While short on details, the tone and general content of the chapter is encouraging. The EU’s initial draft contains two sets of proposals: one on good regulatory practices, including transparency, impact assessment, stakeholder participation, and how to make them operational, and another on steps to reinforce and make more effective current cooperation on types of legislation and regulatory initiatives that have a significant impact on EU-U.S. trade or investment. The EU Commission also released on February 10 a document titled TTIP and Regulation: An Overview. The document includes a section on horizontal provisions, including a section on sanitary and phytosanitary measures, and a section on sectoral provisions, including “chemicals.” The documents are available at http://trade.ec.europa.eu/doclib/press/index.cfm?id=1230#regulatory-cooperation.
By Lisa M. Campbell and Timothy D. Backstrom
On February 12, 2015, the Ninth Circuit Court of Appeals will hear arguments in El Comite Para El Bienestar De Earlimart v. EPA, a case challenging the U.S. Environmental Protection Agency’s (EPA) approval of provisions in a State Implementation Plan (SIP) adopted by California under the Clean Air Act (CAA) that regulate emissions of pesticides (primarily fumigants like methyl bromide) that potentially may contribute to possible exceedances of the National Ambient Air Quality Standard (NAAQS) for ozone. The El Comite case is the latest action in a series of challenges to California’s regulation of emissions of pesticides considered to be volatile organic compounds (VOC) stretching back to 2004. The case will consider substantive issues pertaining to the enforceability of the limits on pesticide VOC emissions in the SIP and the adequacy of those limits to attain compliance with the NAAQS. Of significant interest, it will also include a novel argument that EPA’s conclusion under CAA Section 7410(a)(2)(E) that the SIP did not violate Title VI of the Civil Rights Act is unsupported by the record.
The Plaintiffs will confront a stiff burden in litigating their Civil Rights claim. The Supreme Court has held that Title VI is violated only when actions have a discriminatory impact and such discrimination is intentional. EPA contends that California gave sufficient assurances that the pesticide controls in the SIP do not violate Title VI of the Civil Rights Act, and that it was reasonable for EPA to rely on those assurances when it approved the SIP. The Plaintiffs point to a preliminary finding made in 2011 by the EPA Office of Civil Rights (OCR) concerning the Angelina C. complaint, where OCR determined that emissions of methyl bromide during the years 1995-2001 had a disparate impact on Latino school children. This preliminary finding was later withdrawn following a settlement with California. The Plaintiffs say that given this history, EPA should have required California to provide a more detailed explanation of why its current regulation of pesticide emissions is not violative of Title VI. The Plaintiffs recently attempted to bolster their Title VI argument by asking the Court to take judicial notice of a report on pesticide use near schools issued by the California Environmental Health Tracking program in 2014, but EPA has opposed consideration of this report because it was not part of the administrative record when EPA approved the SIP revisions in 2012.
By Lisa R. Burchi
The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements for Chemical Active Substances and Plant Protection Products according to Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013. Following the adoption in 2009 of Regulation (EC) No. 1107/2009 concerning the placing of plant protection products (PPP), additional regulations were adopted to establish the necessary data requirements for active substances and PPPs. In 2013, Regulation (EU) No. 283/2013 (amended by Regulation (EU) No. 1136/2014) updated the data requirements for active substances, while Regulation (EU) No. 284/2013 updated data requirements for products. These Regulations include transitional measures to explain when certain applications can rely upon former data requirements and when the updated data requirements must be satisfied.
The Guidance provides two charts describing the transitional measures for: (1) applications for approval, renewal, or approval or amendment of approval of Active Substances; and (2) applications for authorization, renewal of authorization, or amendment of authorization of Plant Protection Products. Each chart describes the type of application at issue and the resulting data requirements. For authorization applications, the Guidance divides the types of applications and resulting data requirements into four active substances categories: (1) AIR-2 active substances; (2) AIR-3 active substances/substances not yet renewed; (3) new active substances; and (4) mixtures.
The Guidance was developed to assist EU Member States in consistently applying and interpreting these transitional measures. Many of the data requirement decisions depend on the type of active substances and whether an application is submitted before or after December 31, 2015, so companies considering or planning to submit applications should review the Guidance carefully to determine what data requirements may be applicable.
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.
By Lisa R. Burchi
An ad hoc committee of the National Research Council (NRC) released a report, Review of California's Risk-Assessment Process for Pesticides, following its scientific and technical evaluation of the California Environmental Protection Agency’s (EPA) risk assessment process for pesticides.
The NRC committee review, which commenced in October 2013, examined documents provided by the California EPA’s Department of Pesticide Regulation (DPR) regarding the processes it uses for hazard identification, exposure assessment, dose-response analysis, and risk characterization. The Report discusses the following issues:
■ Setting Priorities Among Pesticides: The NRC committee generally supported DPR’s process under which pesticides are reviewed as candidates for risk assessment, but made recommendations for DPR to: (1) update and provide more details regarding its documentation of the priority setting process; (2) provide more explicit documentation and support for how pesticides are categorized into groups of high, medium, and low priority; and (3) develop a more objective and structured approach for ranking high-priority pesticides.
■ Risk Assessment Methods and Practices: The NRC committee reviewed DPR’s risk assessment guidance documents as well as three recently completed risk assessments for chloropicrin, carbaryl, and methyl iodide. The NRC committee found DPR’s documents to be comprehensive but questioned “whether the extensive effort needed to conduct a comprehensive risk assessment independently of EPA is justified in light of DPR’s resources.” The Committee recommended that DPR: (1) determine whether an independent and comprehensive evaluation of pesticides is required in every case where a risk assessment is performed; (2) incorporate problem formulation and other relevant elements recommended in the 2009 NRC report Science and Decisions: Advancing Risk Assessment into its risk assessment process; and (3) update its guidance documents “regularly and perhaps develop additional reference materials to reflect the most current risk-assessment practices.”
■ California Data to Inform Priority-Setting and Risk Assessment: The NRC committee found DPR’s practice of supplementing its exposure assessments with California-specific information to be “among the most valuable contribution to DPR’s risk-assessment process.” The committee suggests expanding DPR’s current Pesticide Use Reporting (PUR) program to include all licensed pesticide applicators and, if resources allow, “PUR data should be reviewed in relation to air-monitoring data and pesticide-illness surveillance data to determine whether any patterns are evident and to judge the accuracy of exposure assumptions or models.” The committee also had recommendations to improve the reporting of pesticide-related illnesses, including, for example, improving the training of physicians and searching electronic health records.
By Lisa R. Burchi
On January 27, 2015, the European Union (EU) Standing Committee on Plants, Animals, Food and Feed agreed to a proposed list of 77 pesticide active substances to be classified as Candidates for Substitution (CFS). The draft list of CFS is available online. A Question and Answer (Q&A) document regarding the CFS list is available online. Additional information regarding the proposed list is also available online.
This list is an important and long-awaited development under the Plant Protection Product (PPP) Regulation (EC) No. 1107/2009. The Standing Committee clarifies that the CFS active substances are not banned and that approved CFS active substances will remain on the EU market, although there are potentially significant consequences for those listed active substances. Most challenging is the requirement that Member States do the following for new applications for authorization of PPPs containing CFS active substances that are submitted after August 1, 2015: (1) conduct a comparative assessment when evaluating an application for authorization for a PPP containing an active substance approved as a CFS; and (2) not authorize or restrict the use of a PPP containing a CFS for use on a particular crop where the comparative assessment weighing up the risks and benefits demonstrates that safer alternatives exist. In addition, substances not evaluated by the Standing Committee (e.g., substances approved after January 1, 2013) can be identified as a CFS under Article 24 of the PPP Regulation. In those cases, any approval will be limited to a maximum of seven years, compared to 10 or 15 years for other active substances.
The next step will be review and adoption of the CFS list by the European Commission, and then publication of the list as a Commission Regulation in the Official Journal.
By Timothy D. Backstrom
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.
By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.
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.
By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.
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.
By Lisa M. Campbell and Lisa R. Burchi
On January 13, 2015, the Court of Justice (Grand Chamber) of the European Union (EU) overturned a judgment of the General Court of the European Union (General Court) in Stichting Natuur en Milieu and Pesticide Action Network Europe v. Commission.
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.
By Timothy D. Backstrom, Lisa M. Campbell, and James V. Aidala
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.
By Lynn L. Bergeson and Lara A. Hall, M.S., RQAP-GLP
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.
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.
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.
By Lisa M. Campbell
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.