By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi
On August 12, 2016, a three-judge panel of the Ninth Circuit Court of Appeals issued an order denying the U.S. Environmental Protection Agency’s (EPA) request for an additional six months to decide whether to ban agricultural uses of chlorpyrifos. The court opted instead to afford EPA a three month extension, stating that “this is the final extension, and the court will not grant any further extensions."
EPA sought the six month extension on June 29, 2016, to allow time for EPA to complete two scientific analyses that may bear on EPA’s conclusions in the final rule, and to request further public comment before taking final action on a prior proposal to revoke all chlorpyrifos tolerances. The two analyses that EPA wanted to complete are: (1) a refined drinking water assessment that may allow EPA “to develop more tailored risk mitigation for some regions of the country,” and (2) an evaluation of the epidemiological data for chlorpyrifos to determine whether EPA should retain the point of departure based on acetylcholinesterase (AChE) inhibition in the proposed rule.
The court concluded that EPA’s request for a six month extension “is not justified in light of EPA’s history in this matter as well as the court’s previous extensions.” The court stated that EPA’s request was "another variation on a theme 'of partial reports, missed deadlines, and vague promises of future action' that has been repeated for the past nine years,” and that “nothing has changed that would justify EPA’s continued failure to respond to the pressing health concerns presented by chlorpyrifos."
The court ordered EPA to take final action on its proposal to revoke tolerances for chlorpyrifos by March 31, 2017. A further status report by EPA will be due in November 2016.
EPA’s updated analysis of the epidemiological data for chlorpyrifos will be a matter of considerable interest. After EPA issued a proposed rule utilizing a point of departure for chlorpyrifos based on AChE inhibition, EPA issued a blanket determination based on the epidemiological data for chlorpyrifos in which EPA decided to retain the Food Quality Protection Act (FQPA) safety factor for all organophosphate (OP) pesticides. This FQPA determination could cause EPA to conclude that the tolerances for chlorpyrifos must be revoked regardless of the outcome of the refined drinking water assessment.
EPA later proposed to use an alternative point of departure for chlorpyrifos based on biomonitoring data from one of the chlorpyrifos epidemiology studies, but the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) met on April 19-21, 2016, and recommended against this new approach. In its request for an extension, EPA stated that the FIFRA SAP might recommend a “hybrid approach” to adjusting the point of departure for AChE inhibition. The FIFRA SAP meeting minutes do not appear to include such a hybrid recommendation.
In a related development, EPA has reached an agreement with the Columbia Center for Children’s Environmental Health (CCCEH) regarding the release of raw data from one of the chlorpyrifos epidemiology studies. During the FIFRA SAP meeting, concerns were raised regarding use of the CCCEH study without access to the underlying raw data. In an April 19, 2016, letter to Dr. Linda P. Fried, Dean of the Mailman School of Public Health at Columbia University, EPA requested that CCCEH provide access to the underlying data. In her response dated May 18, 2016, Dr. Fried offered to work with EPA “to determine if we can develop one or more data sets that can be properly de-identified, consistent with our obligation to protect the privacy of our research subjects, and that will also enable EPA to conduct its own analyses in order to address its transparency goals” or, in the alternative, offered to allow EPA staff to review the original data “in a secure data enclave onsite at Columbia.” In its June 27, 2016, response, EPA stated that the offer to allow EPA staff to review the underlying data at a secure site did not resolve issues concerning the transparency of EPA’s analysis. This correspondence is available in EPA Docket ID EPA-HQ-OPP-2008-0850. While EPA maintained it is “unnecessary” for CCCEH and EPA to develop redacted data sets, EPA accepted CCCEH’s offer to develop such data sets.
EPA’s request for a six month extension was filed on June 29, 2016, two days after it accepted the offer by CCCEH to develop redacted data sets for the CCCEH epidemiology study. Moreover, the FIFRA SAP meeting minutes issued on July 20, 2016, do not appear to provide the guidance that EPA had expected concerning a potential “hybrid” approach to adjusting EPA’s proposed point of departure for AChE inhibition.
Given the lesser extension granted by the court, it is questionable whether EPA will have sufficient time to review adequately the redacted underlying data sets offered by CCCEH, or even to determine whether those redacted data sets are adequate for this review, and to make any determination based on such data before EPA issues a supplementary proposal based on the refined drinking water assessment and the updated epidemiology assessment. The court has stated that it will entertain no further extension requests, so EPA must complete its work expeditiously to allow time for comment before final action is due on March 31, 2017.
By Lisa M. Campbell and Timothy D. Backstrom
On July 20, 2016, the U.S. Environmental Protection Agency (EPA) issued a memorandum attaching minutes from the April 19-21, 2016, FIFRA Scientific Advisory Panel (SAP) meeting, Transmittal of Meeting Minutes of the April 19-21, 2016 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP or Panel) Meeting Held to Consider and Review Scientific Issues Associated with “Chlorpyrifos: Analysis of Biomonitoring Data.” This SAP was convened to advise EPA regarding the evaluation of biomonitoring chlorpyrifos data from epidemiology studies conducted by the Columbia Center for Children’s Environmental Health (CCCEH).
The minutes indicate that the SAP has significant concerns with EPA’s proposal to use the biomonitoring chlorpyrifos data from the CCCEH epidemiology studies to establish a point of departure (PoD) for chlorpyrifos risk assessment. The minutes state: “Because many uncertainties cannot be clarified, the majority of the Panel does not have confidence that the Columbia Center for Children’s Environmental Health (CCCEH) cord blood data on chlorpyrifos concentrations can accurately be used in quantitative risk assessment to determine a Point of Departure (PoD).” A major source of uncertainty cited by the FIFRA SAP is “the lack of verification and replication of the analytical chemistry results that reported very low levels of chlorpyrifos (pg/g),” because EPA had to impute a finite quantitative value to “a large fraction of cord blood samples included in the analyses presented with levels below [level of detection (LOD)].” Moreover, some SAP members “thought the quality of the CCCEH data is hard to assess when raw analytical data have not been made available, and the study has not been reproduced.”
The SAP also, however, stated that “both epidemiology and toxicology studies suggest there is evidence for adverse health outcomes associated with chlorpyrifos exposures below levels that result in 10% red blood cell (RBC) acetylcholinesterase (AChE) inhibition (i.e., toxicity at lower doses).” Nevertheless, it agreed with EPA that “applying additional safety factors to the AChE PoDs to account for a possible noncholinergic mode of action (MOA) would be problematic because of challenges in justifying any particular value for such an adjustment.”
Of note, the SAP concluded that it would be appropriate to use a “10X intra-species extrapolation factor” in any analysis based on the cord blood data. It also identified other sources of uncertainty that should be considered in such an analysis, including “the inability of single measures of chlorpyrifos concentration in blood to provide information regarding source, frequency, duration and magnitude of exposure, and how these exposures are linked to specific outcomes measured in the CCCEH study participants.” Although EPA suggested in a Status Report filed in the chlorpyrifos litigation pending in the Ninth Circuit Court of Appeals on June 29, 2016, that the FIFRA SAP might recommend a “hybrid approach” that EPA could use in lieu of a PoD based on AChE inhibition, thereby altering the prior EPA analysis for chlorpyrifos, the SAP minutes do not include a recommendation for such a hybrid methodology.
Given the concerns expressed by the SAP regarding EPA’s proposal to derive a PoD from cord blood biomonitoring data collected in the CCCEH epidemiology studies, it may be unlikely that EPA will further pursue this specific approach. It is less clear whether EPA will be inclined to propose any further adjustments to its existing risk assessment for chlorpyrifos, which utilizes a PoD based on animal AChE data, along with intra-species and inter-species uncertainty factors and an additional Food Quality Protection Act (FQPA) 10X factor. EPA’s decision to retain the special FQPA factor in its risk assessment for chlorpyrifos will remain controversial, because it is based on an assessment of the value and significance of several epidemiology studies for chlorpyrifos that many in the pesticide industry strongly dispute. The discussion in the minutes of the uncertainties resulting from the refusal of the CCCEH investigators to provide underlying raw data may provide further support for arguments by industry that EPA should not predicate risk assessments on the epidemiology studies for chlorpyrifos before obtaining and reviewing these data.
More information on the FIFRA SAP and its surrounding legal issues is available in our blog item EPA Requests Six Month Extension of Deadline for Decision on Chlorpyrifos Tolerance Revocation, and more generally on our blog with keyword chlorpyrifos.
By Lisa M. Campbell and Timothy D. Backstrom
In two recent orders issued in the neonicotinoid seed treatment case Anderson v. McCarthy, the U.S. District Court for the Northern District of California declined to take immediate action in response to a motion by the U.S. Environmental Protection Agency (EPA) requesting that the Court dismiss the case for lack of subject matter jurisdiction. This case involves allegations by a coalition of beekeepers, farmers, and non-governmental organizations (Petitioners) that EPA has incorrectly applied the treated article exemption to seeds coated with neonicotinoid pesticides.
The Court issued an order denying the EPA motion to dismiss on May 13, 2016. In that order, the Court concluded that factual issues to be resolved in deciding whether a 2013 EPA guidance document constitutes a final reviewable action are so “intertwined” with the substantive issues in the case that it would be inappropriate to try to resolve the jurisdictional issues until after the filing of summary judgment motions. The Court stated:
- If the 2013 Guidance did consummate a new rule, and thus a final agency action, then defendants clearly violated federal law by failing to comply with rulemaking requirements. If the 2013 Guidance did not constitute final agency action, then subject-matter jurisdiction is lacking, and the case must be dismissed.
In the May 13, 2016, order, the Court also stated that the decision to defer action on the jurisdictional issues was a “close call,” because “defendants put forth a strong argument in support of dismissal of the lawsuit at the Rule 12 stage.”
On May 23, 2016, EPA filed another motion requesting that the Court clarify the May 13, 2016, order. In its clarification motion, EPA pointed out that the May 13, 2016, order addressed only three of the counts in the complaint challenging the 2013 Guidance, but did not address Count II, which alleged a general “failure to act” because EPA has not regulated neonicotinoid coated seeds as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA, resolution of this count involves a “pure issue of law,” because the Petitioners “failed to identify any discrete, legally-required action that EPA has failed to perform.”
The EPA motion for clarification was scheduled to be heard on July 21, 2016, but the Court issued an order on July 14, 2016, vacating that hearing. The new order stated that “defendants raised a fair point,” because “the Court’s order on the motion to dismiss failed to expressly come to grips with that part of the motion directed at the ‘failure to act’ claim for relief.” Nevertheless, the Court concluded that “no harm will be done in postponing resolution of that issue until summary judgment.”
Although the Court has declined to rule on any jurisdictional question concerning the Petitioners’ complaint posed by EPA until after the parties have filed their respective motions for summary judgment, this case may still be dismissed once the Court engages in the requisite fact-finding. When the Court stated that EPA made a “strong argument” in support of immediate dismissal, it appeared to be a clear signal that this case may yet be resolved on jurisdictional issues. The Court may decide based on the record whether the 2013 Guidance was intended to change or to modify the existing policy on applicability of the treated article exemption to coated seeds. The Court may also consider whether or not EPA intended the policy set forth in the 2013 Guidance to be binding in deciding whether or not to bring subsequent enforcement actions. In addition, the Court will need to consider whether it can review a general “failure to act” in the absence of any allegation that EPA was required to take some specific action.
By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi
On July 1, 2016, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register an interim final rule adjusting penalty amounts for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations by more than three times the current level, in some cases. The rule also adjusts the level of statutory civil monetary penalty amounts for the other statutes that EPA administers. EPA issued this interim final rule pursuant to 2015 amendments to the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 (DCIA) (collectively the 2015 Act). The 2015 Act sets forth new requirements for agencies to: (1) adjust the level of statutory civil penalties with an initial “catch-up” adjustment through an interim final rulemaking; and (2) beginning January 15, 2017, make subsequent annual adjustments for inflation.
EPA states that the purpose of the 2015 Act is to “provide a mechanism to address these issues by translating originally enacted statutory civil penalty amounts to today’s dollars and rounding statutory civil penalties to the nearest dollar,” and “[o]nce Federal agencies issue the 2016 one-time catchup rule, each statutory civil penalty amount will be adjusted every year to reflect the inflation that has thereafter accrued.”
EPA sets forth a five step procedure to determine the cost-of-living or inflation adjustment to statutory civil penalties. Through this interim final rule, EPA amends 40 C.F.R. Part 19 of EPA’s regulations, Adjustment of Civil Monetary Penalties for Inflation, to include:
- The operative statutory civil penalty levels, as adjusted for inflation, for violations occurring on or before November 2, 2015, and for violations occurring after November 2, 2015, where penalties are assessed before August 1, 2016; and
- The operative statutory civil penalty levels, as adjusted for inflation, where penalties are assessed on or after August 1, 2016, for violations that occurred after November 2, 2015.
Table 2 to 40 C.F.R. Section 19.4 sets forth the specific statutory civil penalty provisions of statutes administered by EPA, with the original statutory civil penalty levels, as enacted, with the last column of which displaying the operative statutory civil penalty levels where penalties are assessed on or after August 1, 2016, for violations that occurred after November 2, 2015. Specific changes to FIFRA penalties in Table 2 are as follows:
- U.S. Code citation: 7 U.S.C. 136(a)(1); Environmental Statute: FIFRA; Statutory civil penalties, as enacted: $5,000; Statutory civil penalties for violations that occurred after November 2, 2015, and assessed on or after August 1, 2016: $18,750; and
- U.S. Code citation: 7 U.S.C. 136(a)(2)*; Environmental Statute: FIFRA; Statutory civil penalties, as enacted: $1,000/500/1,000; Statutory civil penalties for violations that occurred after November 2, 2015, and assessed on or after August 1, 2016: $2,750/$1,772/$2,750.
* Note that 7 U.S.C. 136(a)(2) contains three separate maximum civil penalty provisions. The first mention of $1,000 and the $500 statutory maximum civil penalty amount were originally enacted in 1978 (Pub. L. No. 95-396) and the second mention of $1,000 was enacted in 1972 (Pub. L. No. 92-516).
Despite the large increase in some of the civil penalty amounts, EPA has determined, pursuant to Administrative Procedure Act (APA) Section 553(b)(3)(B), that it “would be impracticable and unnecessary to delay publication of this rule pending opportunity for notice and comment.” According to EPA, notice and comment are not necessary “because the 2015 Act does not allow agencies to alter the rule based on public comment.” This rationale presumes that EPA has correctly determined the size of the initial “catch-up” penalty adjustment mandated by the 2015 Act. Despite EPA’s APA finding, EPA would likely be obligated to consider any comment arguing that EPA did not determine the size of this initial adjustment correctly. Future annual adjustments should be much smaller and, thus, presumably not as likely to be as controversial.
By Lisa M. Campbell and Timothy D. Backstrom
On June 29, 2016, the U.S. Environmental Protection Agency (EPA) submitted a status report in the Ninth Circuit Court of Appeals case concerning a petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke the tolerances and cancel the registrations for chlorpyrifos. The Court of Appeals issued an order on December 10, 2015, requiring EPA to take final action concerning the PANNA and NRDC petition no later than December 30, 2016. To comply with an earlier order, EPA issued a proposed rule to revoke the tolerances for chlorpyrifos before it could complete a refined drinking water assessment or propose a new “point of departure” for chlorpyrifos based on biomonitoring data from an epidemiological study.
EPA’s status report states that it has made “significant progress” towards meeting the December 30, 2016, deadline, but “extraordinary circumstances exist that make it impracticable for the Agency to meet the Court’s deadline.” Based on these extraordinary circumstances, EPA has requested a six-month extension for final action on the petition.
EPA notes that a proposed new point of departure was presented to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP), but was not favorably received. At the same time, EPA states that the SAP “raised concerns about the approach EPA adopted in the Proposed Rule, namely that the continued use of acetylcholinesterase inhibition as the point of departure may not be sufficiently health protective.” EPA infers that the SAP may be disposed to recommend a “hybrid approach,” but the written SAP report will not be issued until the end of July, 2016.
EPA states that it had planned to seek public comment on its refined drinking water assessment and new point of departure for chlorpyrifos immediately after the SAP meeting. EPA now believes that it would be best to obtain the final SAP report before deciding how to establish a point of departure. Accordingly, EPA proposes to seek comment on its refined drinking water analysis and analysis of the epidemiological data by early Fall 2016, and to take final action on the PANNA and NRDC petition by June 30, 2017.
EPA expects that the refined drinking water assessment for chlorpyrifos will allow “tailored risk mitigation” that could eliminate one basis for the proposed revocation of chlorpyrifos tolerances. In contrast, EPA’s concerns about the potential neurodevelopmental effects of chlorpyrifos may not be as readily addressed by risk mitigation. If EPA decides either to retain the Food Quality Protection Act (FQPA) 10X safety factor for chlorpyrifos based on purported neurodevelopmental effects observed in epidemiological studies, or to adopt some “hybrid” risk assessment methodology for neurodevelopmental effects in response to the SAP recommendations, debate on the merits of doing so will likely be strong. The status report does not appear to suggest that EPA is currently considering revisiting its general views on the chlorpyrifos epidemiological data; if EPA is not doing so, considerable continued debate on this issue is also likely.
By Lisa M. Campbell and Lisa R. Burchi
On May 11, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Compliance (OC) and Office of Pesticide Programs (OPP) issued a memorandum to its regional Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Division Directors and Branch Chiefs to establish a joint position of OC and OPP “for how regions should respond to requests for EPA-issued Certificates of Establishment (COEs) and Certificates of Origin (COOs).”
OC and OPP state that the need for a joint position is based on recent requests by exporters to have EPA certify that a specific facility is a registered pesticide producing establishment, or certify that a particular pesticide product was produced at a specific establishment. These certificates are used by exporters to submit to foreign governments that require “‘EPA documentation’ prior to allowing registered and unregistered pesticide products into their jurisdictions.”
Under the new national approach, EPA regional offices are to stop issuing COEs or COOs. In the memorandum, OC and OPP state the following three factors in support of this approach:
- EPA does not believe that FIFRA provides the statutory authority for issuing either a COE or a COO;
- EPA does not believe that regions have the information necessary to certify the origin of an exported pesticide, registered or unregistered, arriving at a foreign destination; and
- EPA believes that COE letters, particularly for unregistered pesticides, may be misleading to foreign governments.
Under this approach whereby EPA regions will cease the previously routine practice of issuing COEs and COOs, companies may encounter difficulties or business disruptions with some foreign governments that have traditionally required COEs and COOs. OC and OPP state that they are “working on making FIFRA Section 7 establishment registration information (that which is not confidential business information) available on OC’s website,” which EPA states could be relied upon in lieu of COEs. As for COOs, OC and OPP suggest that registrants: (1) “should be directed to the exporters for the COO, which can then be certified by a State or local chamber of commerce”; or (2) could seek commercial third-party service providers to handle COO processing for an exporter.
EPA states that the new joint position has no effect on Gold Seal Letters issued by OPP that provide the registration status of a registered pesticide product. Gold Seal Letters will still be issued upon request to the appropriate registered division within OPP.
Registrants are concerned about this new approach, however, and it is likely that debate on it will continue.
By Lisa M. Campbell and Lisa R. Burchi
In an April 22 memorandum, the Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) announced its intent to begin preliminary research to assess the EPA’s inspections of, and enforcement against, illegal pesticide imports.
OIG states that its objective with this project is to “determine whether the EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) import inspection program is effectively deterring, identifying and confiscating illegal pesticide imports, to protect human health and the environment.” OIG’s efforts will include determining whether EPA is effectively identifying pesticide imports for inspection and sampling, as well as whether EPA is taking appropriate enforcement action against noncompliant imports.
OIG notes that this project is included in its fiscal year 2016 Annual Plan. The Annual Plan notes a project commencement date of June 2016 and describes its efforts as follows:
- The EPA’s enforcement program addresses the illegal importation of unregistered or otherwise noncompliant pesticide products into the United States. This project could result in reduced risks to human health and the environment due to Federal Insecticide, Fungicide and Rodenticide Act imports noncompliance, while assuring effective deterrence through inspections and enforcement actions. We will seek to determine whether the Federal Insecticide, Fungicide and Rodenticide Act Import Inspection program effectively deters or identifies and confiscates illegal pesticide imports to protect human health and the environment.
OIG’s review of EPA’s activities in this area should come as no surprise considering that the EPA Office of Enforcement and Compliance Assurance (OECA) has identified import border compliance as one of its three FIFRA focus areas for the past several years. For example, OECA’s FY 2016-2017 National Program Manager Guidance (NPMG), which sets forth OECA’s priority-setting strategies, has made EPA Regions aware of EPA’s strong interest in import compliance. The NPMG suggests that the Regional office efforts in this regard include monitoring import compliance through inspections; focusing on “high-risk” unregistered pesticides and importers with a history of noncompliance or significant importation activities from countries frequently associated with noncompliant shipments; and overseeing the transition of manual review of Notices of Arrival (NOA) to the Automated Commercial Environment in the International Trade Data System (ACE/ITDS). Indeed, there is a noticeable uptick in EPA Regional office review of NOAs and OECA enforcement of noncompliant pesticide imports.
Companies that import pesticides should carefully review their import policies and how they prepare their NOAs to ensure they do not invite EPA scrutiny and potential enforcement action.
By Lisa M. Campbell and Lisa R. Burchi
On March 10, 2016, the U.S. Environmental Protection Agency (EPA) filed a motion to dismiss for lack of subject matter jurisdiction and a supporting memorandum of law (Memorandum) in Anderson v. McCarthy, Case No. 3:16-cv-00068 (N.D. Cal. filed Jan. 6, 2016). In support of its motion, EPA states that the District Court lacks jurisdiction because three of the four claims stated in the complaint “seek review of a guidance document that does not constitute ‘final agency action’ reviewable under the Administrative Procedure Act [APA] or the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA],” and that the remaining claim “which asserts a failure to regulate under and enforce [FIFRA], fails because Plaintiffs have not identified a clearly imposed duty on the part of EPA to take some discrete action to regulate under or enforce the Act.”
The Complaint was filed by a coalition of U.S. beekeepers, farmers, and affiliated non-government organizations (Petitioners) who requested that the District Court provide declaratory relief stating that seeds coated with neonicotinoid insecticides are not eligible for the “treated article” exemption under FIFRA. Petitioners argue, in part, that the following language from EPA’s 2013 Inspection Guidance (Guidance) provides a new interpretation of the scope of the “treated article”:
Inspectors may also take into account any locations of treated seed planting when identifying locations of potential pesticide sources. Note: Treated seed (and any resulting dust-off from treated seed) may be exempted from registration under FIFRA as a treated article and as such its planting is not considered a “pesticide use.” However, if the inspector suspects or has reason to believe a treated seed is subject to registration (i.e., the seed is not in compliance with the treated article exemption), plantings of that treated seed may nonetheless be investigated.
The Complaint argues that this Guidance improperly expanded the scope of the treated article exemption and was in effect an unlawful rule issued without prior notice and comment. The Complaint seeks an order from the District Court declaring, in part, that “unregistered seeds do not fit within the ‘treated article’ exemption from pesticide regulation in 40 CFR § 152.25(a) and must be regulated as pesticidal products under FIFRA.”
With regard to the scope of the treated article exemption, EPA in its Memorandum states that the language from the Guidance, which is for the use of inspectors and not the general public, is:
[A] far cry from prescribing the law or policy as to exemption of treated seed as a treated article under 40 C.F.R. § 152.25(a), as they in no way implement, interpret, or prescribe law or policy. Instead, this language in the Inspection Guidance is but one recommendation to inspectors who are investigating all possible sources of pesticides, including treated seed.
EPA further argues that the “note” in its Guidance is “nothing more than the unremarkable reiteration of EPA’s longstanding view of the treated article exemption in 40 C.F.R. § 152.25(a).” EPA states that the applicability of the treated article exemption has been discussed publicly by EPA since 2003 in an document published jointly by EPA and Canada Pest Management Regulatory Agency entitled “Harmonization of Regulation of Pesticide Seed Treatment in Canada and the United States.” In that document, EPA states that it “plainly indicates that where the conditions of the treated article exemption are met, ‘[s]eeds for planting which are treated with pesticides registered in the U.S. are exempt from registration as pesticides and may be freely distributed and sold within the U.S.’” Thus, EPA states that Petitioners “have failed to meet their burden to demonstrate that the Inspection Guidance (or any other action) constitutes “final agency action” as that term is used in the APA, and thus they have not met their burden of demonstrating jurisdiction.”
On March 16, 2016, Intervenor-Defendants CropLife America, the American Seed Trade Association, the American Soybean Association, the National Cotton Council of America, the National Association of Wheat Growers, the National Corn Growers Association, and the Agricultural Retailers Association filed to join EPA’s Motion to Dismiss.
More information on the complaint is available in our blog item EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA.
By Lisa M. Campbell and Timothy D. Backstrom
On March 8, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register stating that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will hold a three-day meeting scheduled for April 19-21, 2016, from 9:00 a.m. to 5:00 p.m. (EDT) to consider and review Chlorpyrifos: Analysis of Biomonitoring Data. The meeting will be held at EPA’s Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, Virginia 22202. The meeting will be webcast. More information will be posted online.
The notice states that written comments are encouraged through April 5, 2016, and that requests for oral comments are encouraged to be submitted by April 12, 2016, but that both may be submitted until the date of the meeting. Nominations of candidates to serve as ad hoc members of FIFRA SAP for the meeting are requested on or before March 23, 2016.
In this meeting, EPA states that it will solicit comment from FIFRA SAP on the evaluation of biomonitoring data using the physiologically-based pharmacokinetic (PBPK) model, proposed points of departure and extrapolation/uncertainty factors, and examples of a proposed approach to use the PBPK model to simulate internal doses of chlorpyrifos from current exposure patterns from drinking water, food, and worker exposure. The FIFRA SAP has been reviewing the human health effects of chlorpyrifos since 2008. The notice states that “at this point in time, the Agency’s analysis of biomonitoring data from the cord blood collected as part of the Columbia University epidemiology studies has progressed to a point where peer review would be useful” and that “[s]pecifically, the Agency has done additional characterization of the pharmacokinetic profile of simulated exposures from oral and dermal exposures using the PBPK model.”
The notice states that in 2008 and 2012, the FIFRA SAP “cautioned EPA against using the biomonitoring data from epidemiology studies … to directly derive points of departure due to uncertainties associated with a lack of knowledge about timing of indoor chlorpyrifos applications and a single measure of exposure (cord blood).” The 2012 FIFRA SAP recommended that EPA use the PBPK model to further characterize the dose estimates in the epidemiology studies.
The notice states that EPA would have preferred to complete its analysis of the available biomonitoring prior to commencing rulemaking, but that the timing for the proposal was directed by the U.S. Court of Appeals for the Ninth Circuit, which ordered EPA to respond to an administrative petition to revoke all chlorpyrifos tolerances by October 31, 2015.
More information on the Ninth Circuit case is available in our blog item Circuit Court Grants Writ of Mandamus Requiring EPA to Act on Petition to Ban Chlorpyrifos.
EPA’s decision to utilize biomonitoring data that was collected as part of the Columbia University epidemiology studies for chlorpyrifos to derive proposed points of departure for risk assessment purposes will be highly controversial. If EPA proceeds to use biomonitoring data from epidemiological studies to derive points of departure for risk assessment purposes, the implications for all pesticide product risk assessments could be significant. Whether EPA can defensibly do so from both a scientific and legal standpoint is a subject that will likely be debated strongly. All pesticide registrants should monitor these developments closely.
By Lisa M. Campbell and Timothy D. Backstrom
On February 29, 2016, the U.S. Environmental Protection Agency (EPA) released a prepublication copy of a notice of intent to cancel all Bayer CropScience, LP and Nichino America, Inc. (BCS/NAI) flubendiamide products. The affected products are:
- EPA Reg. No. 264-1025 -- BELT SC Insecticide;
- EPA Reg. No. 71711-26 -- FLUBENDIAMIDE Technical;
- EPA Reg. No. 71711-32 -- VETICA Insecticide; and
- EPA Reg. No. 71711-33 -- TOURISMO Insecticide.
The cancellation notice was issued by EPA, pursuant to Section 6(e) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and announces EPA’s intent to cancel the registration of these four products based on the registrants’ failure to comply with a required condition of their registrations. Under this condition, which EPA alleges was agreed to by the registrants, each flunbendiamide registrant is required to submit a voluntary cancellation request if EPA finds that the product causes unreasonable adverse effects on the environment.
EPA made such a finding of unreasonable adverse effects in a decision memorandum issued on January 29, 2016, but BCS/NAI has rejected EPA’s request to submit a voluntary cancellation. More information on BCS/NAI’s refusal to submit a request for voluntary cancellation is available in our blog item Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide.
EPA’s finding of unreasonable adverse effects is based on the purported risk to aquatic invertebrates associated with flubendiamide. More information on EPA’s rationale, including the decision memorandum, is available on EPA’s website. After the cancellation notice is published, each registrant will have 30 days to request a hearing concerning the notice. FIFRA Section 6(e) provides that the only matters that may be considered in the resulting hearing are whether the registrants have complied with the condition in question and whether EPA’s determination on existing stocks is consistent with FIFRA. In contrast, the registrants have stated that EPA is required to provide an adjudicatory hearing concerning the substantive basis for EPA’s determination that the products in question cause unreasonable adverse effects on the environment.
The dispute between BCS/NAI and EPA concerning cancellation of the conditional registrations for flubendiamide products will be carefully watched by the pesticide industry. The critical issue is whether EPA can effectively circumvent the adjudicatory hearing that would otherwise be available on the substance of EPA’s determination concerning risks and benefits by imposing a condition that requires affected registrants to accept EPA’s determination. EPA will argue that the registrants accepted the condition in question when the registrations for flubendiamide were first issued. The registrants will argue that EPA may not use such a condition to constrain hearing rights because this contravenes the intent of FIFRA.