By James V. Aidala and Lisa R. Burchi
On November 18, 2021, the United Farm Workers and several other non-governmental organizations (NGO) filed a petition with the U.S. Environmental Protection Agency (EPA) to revoke all food tolerances and cancel registrations for organophosphate (OP) pesticides (Petition). The Petition was filed pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 346a(d), the Administrative Procedure Act (APA), 5 U.S.C. Section 551, and the First Amendment Constitutional Right to Petition.
The Petition seeks final EPA actions to revoke tolerances and cancel registrations for 15 OPs by the registration review deadline of October 1, 2022.
The Petition also states that EPA must take the following actions:
- Update EPA’s human health risk assessments (HHRA) for OP pesticides to use a regulatory endpoint that the Petition claims will protect children from learning disabilities and other neurodevelopmental harm.
- Complete Endangered Species Act (ESA) consultations and ensure its registrations comply with the ESA;
- Conduct endocrine disruptor screening of all pesticides.
- Complete a cumulative risk assessment for all the OPs to address their cumulative acute poisoning and neurodevelopmental effects.
The Petition focuses on 15 OPs that are currently going through registration review:
- Acephate (EPA-HQ-OPP-2008-0915);
- Bensulide (EPA-HQ-OPP-2008-0022);
- Chlorethoxyfos (EPA-HQ-OPP-2008-0843);
- Chlorpyrifos-methyl (EPA-HQ-OPP-2010-0119);
- Diazinon (EPA-HQ-OPP-2008-0351);
- Dichlorvos (EPA-HQ-OPP-2009-0209);
- Dicrotophos (EPA-HQ-OPP-2008-0440);
- Dimethoate (EPA-HQ-OPP-2009-0059);
- Ethoprop (EPA-HQ-OPP-2008-0560);
- Malathion (EPA-HQ-OPP-2009-0317);
- Naled (EPA-HQ-OPP-2009-0053);
- Phorate (EPA-HQ-OPP-2007-0674);
- Phosmet (EPA-HQ-OPP-2009-0316);
- Terbufos (EPA-HQ-OPP-2008-0119); and
- Tribufos (EPA-HQ-OPP-2008-0883).
Now that EPA is in receipt of the Petition, it must determine that it has received a “complete” petition to revoke a tolerance based on criteria set forth in EPA’s regulations (40. C.F.R. § 180.7). If EPA determines the Petition is complete, it will publish in the Federal Register within 30 days a notice of filing for the Petition, which must include the informative summary of the Petition submitted by the petitioner. FFDCA Section 408(d)(3). A public comment period follows.
Generally, the Petition is an important signaling document that the petitioners use to outline how EPA should approach the 2022 registration review deadline for these OP products. It signals that unless EPA completes all elements of a registration review, including a complete ESA assessment and an endocrine disruptor review -- which may be impossible for EPA to complete -- then EPA should act now to revoke OP tolerances in light of arguments contained in the Petition. It stresses the environmental justice commitments announced by the Biden Administration, arguing that evidence is clear, in their view, of the need to take immediate action to end OP use across virtually all of the members of the class. It seems to anticipate that even if EPA rolls out registration reviews of the individual OP pesticides before the deadline, there will likely be comment and debate about the specific analyses and evaluation of each member of the category. This would additionally delay the completion of any revised cumulative risk assessment for the OPs.
From the view of the petitioners, not only will EPA miss the 2022 deadline, but they also argue the evidence is sufficient now for EPA to take action to revoke tolerances for these compounds based on evidence already before EPA. Other stakeholders and EPA’s eventual analyses will dispute such conclusions, but completing registration review (as defined in the Petition) will likely be impossible to complete before next October. As a result, the Petition here suggests the template these advocacy groups will use to challenge continued registration of OP products past the 2022 deadline.
By Lisa M. Campbell and Timothy D. Backstrom
On August 7, 2019, the League of United Latin American Citizens, Pesticide Action Network North America, Natural Resources Defense Council, and other petitioners (Petitioners) filed a new petition in the Ninth Circuit Court of Appeals seeking judicial review of United States Environmental Protection Agency (EPA) orders denying their request that EPA revoke all tolerances and cancel all registrations for chlorpyrifos. On August 8, 2019, New York, California, Hawaii, Maryland, Vermont, Washington, Massachusetts, and the District of Columbia (States) also filed a new petition for judicial review concerning the refusal of EPA to ban chlorpyrifos. The Petitioners and the States seek judicial review of the July 18, 2019, final order by EPA dismissing all objections to the initial decision by EPA to retain tolerances and registrations for chlorpyrifos, and of EPA’s March 29, 2017, order that initially denied a 2007 petition to revoke all tolerances and cancel all registrations for chlorpyrifos.
The Petitioners and the States also seek consolidation of their newly filed petitions for judicial review with currently pending chlorpyrifos litigation in LULAC, et al. v. Wheeler, et al. As part of rehearing in the LULAC case, the Ninth Circuit vacated a prior decision that ordered EPA to cancel chlorpyrifos registrations, and instead issued a writ of mandamus requiring EPA to respond to objections to the 2017 denial order within 90 days. EPA then issued the July 18, 2019, order denying all objections, along with a motion on July 19, 2019, to dismiss the LULAC case as moot. EPA seeks dismissal of LULAC because it contends that the 2017 initial order was never itself reviewable, and EPA has now done everything that the writ of mandamus required. The Petitioners oppose the motion to dismiss because it would require the Court to take a position on a jurisdictional issue which they contend was not decided during rehearing. The Petitioners and the States also argue that dismissal would be unnecessary and inefficient, requiring the challenging parties to reconstitute the record for review compiled in LULAC.
Petitioners also note that the Ninth Circuit retained jurisdiction when it issued mandamus in LULAC, and they request that their combined challenge to the EPA decision to retain the existing tolerances and registrations for chlorpyrifos be heard by the Court en banc as well.
The latest petitions for judicial review of EPA’s 2019 decision to retain all tolerances and registrations for chlorpyrifos pending registration review were anticipated by all parties, and all parties agree that the procedural requisites for a judicial determination concerning the legality of EPA’s final decision to deny the 2007 administrative petition have now been satisfied. The Petitioners and the States will likely argue that prior scientific determinations by EPA, including EPA analysis of epidemiology studies that purport to establish a link between exposure to chlorpyrifos and adverse neurodevelopmental effects in children, require that EPA proceed to revoke all tolerances and cancel all registrations for chlorpyrifos, while EPA will likely argue that difficult scientific issues concerning chlorpyrifos remain unresolved and should be addressed by EPA as part of the pending registration review for chlorpyrifos.
In addition to the dispute about combining the new petitions for review with the LULAC case, an interesting element of the latest filing by the Petitioners is that they attempt to bootstrap en banc review of the 2019 order in which EPA finally denied the administrative petition to revoke tolerances and cancel registrations for chlorpyrifos. En banc review for an initial hearing (as opposed to en banc rehearing in a previously decided case) is allowed by the applicable appellate rules, but such review is disfavored and would be highly unusual. Petitioners argue that it is warranted here because the en banc panel in the rehearing in the LULAC case reserved jurisdiction. Given the motion by EPA to dismiss the LULAC case as moot, it can be presumed that EPA is likely to oppose this vicarious argument for en banc judicial review. EPA can argue that the only reason the en banc panel retained jurisdiction was to assure that EPA would timely comply with the writ of mandamus that required EPA to rule on the objections within 90 days.
For further information on the long history of litigation concerning the petition to ban chlorpyrifos, please review our prior blog entries.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
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:
- Providing a letter to the petitioner acknowledging receipt of the petition;
- Communicating petition decisions to the petitioner in writing; and
- Providing updates to petitioners about the status and progress of pending petitions.
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.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On June 10, 2015, the Ninth Circuit Court of Appeals granted a petition for a writ of mandamus for a petition filed by Pesticide Action Network North America and Natural Resources Defense Council in 2007. That petition requested that EPA cancel all registrations and revoke all tolerances for the insecticide chlorpyrifos. An order granting a writ of mandamus is unusual, and indicates that the Court is impatient about what it perceives to be the slow pace of review by the U.S. Environmental Protection Agency (EPA). The petitioners previously sought such a writ in 2012, and the Court denied that request without prejudice in 2013. EPA took action in 2012 that addressed seven out of the ten issues originally raised by the petitioners, and the Court found in 2013 that the time taken by EPA to address the petition was “not unreasonable in light of the complexity of the issue.” On March 26, 2015, EPA wrote to the petitioners stating that it intends to deny their petition to cancel registrations and revoke tolerances for chlorpyrifos. EPA bases this anticipated decision on a new human health risk assessment incorporating a physiologically based pharmacokinetic-pharmacodynamic (PBPK-PD) model that allows EPA to estimate human risk directly rather than extrapolating from animal data. Based on this model, EPA determined that label changes are needed to mitigate certain occupational exposures and localized drinking water exposure, and has requested comment on these findings.
EPA counsel represented during oral argument in the case that EPA could complete its review of the comments and take action on the petition by mid-September 2015. In response, the Court has issued an order directing EPA either to submit a status report by June 30, 2015, stating whether EPA intends to finalize its preliminary denial, or whether EPA has decided instead to grant the petition in whole or in part. If the petition will be denied, EPA must issue the final denial decision by September 15, 2015.
The schedule imposed by the Court order is demanding, but it is likely that EPA will make every effort to meet it. The Court did not require EPA to respond to all of the comments on the risk assessment, or to determine what mitigation measures will ultimately be required, by the September deadline. Although EPA would normally prefer to complete all related tasks and to compile a comprehensive administrative record before issuing the final decision denying the petition to cancel chlorpyrifos, that would be very challenging to do in this instance. The comment period for the current risk assessment closed on April 30, 2015, and EPA must evaluate and respond to detailed comments on a complex assessment, one which has some important issues subject to serious dispute by the affected registrants. For example, Dow Agrosciences LLC submitted a 130 page set of comments on April 29, 2015, in addition to comments received from the general public, users of the pesticide, and other interested parties. If EPA determines it will proceed with its stated intent to deny the petition to cancel, this action may precede the mitigation measures that EPA imposes based on the chlorpyrifos risk assessment and the comments on that assessment. Nevertheless, because the petitioners are likely to challenge the denial decision as well, EPA will need to prepare an adequate explanation of the reasons for the denial and to expedite the related administrative actions to the extent that is practicable.
By Lisa M. Campbell and James V. Aidala
On May 8, 2015, in El Comite Para El Bienestar De Earlimart v. EPA, a Panel of the U.S. Court of Appeals for the Ninth Circuit denied a petition for review filed by several groups that the court describes as “community organizations” who challenged the U.S. Environmental Protection Agency’s (EPA) 2012 approval of California State Implementation Plan (SIP) elements under the Clean Air Act (CAA), including its related approval of certain fumigant regulations. This challenge was previously discussed in our blog post "Ninth Circuit to Consider Civil Rights Issue in Review of California SIP".
Of particular interest in the case is the contention before the court that “EPA failed to secure necessary assurances from California that its proposed rules would not violate Title VI of the Civil Rights Act by exposing Latino schoolchildren to a disparate impact from pesticide use.” The court rejected this and other contentions by the community groups.
The court’s findings with regard to the alleged Civil Rights violation state a standard that appears to defer greatly to EPA and its review of the record. More specifically, the court found with regard to the claimed Civil Rights Act violation that “EPA explained that this evidence failed to draw any connection between the proposed rules and a potential disparate impact,” and that EPA “fulfilled its duty to provide a reasoned judgment because its determination was cogently explained and supported by the record.”
By way of background with regard to the Civil Rights Act claim, the petitioners argued that EPA’s determination that California provided assurances that no federal or state law prohibits the SIP approval was arbitrary and capricious because EPA failed to consider evidence claimed to support a violation of Title VI of the Civil Rights Act. This claim rested on an EPA finding of a Title VI violation in connection with an earlier administrative complaint, referred to as the Angelita C. complaint, which was filed with the EPA Office of Civil Rights in 1999. There, Latino parents and schoolchildren alleged that schools with high percentages of Latino children were disparately affected by the California Department of Pesticide Regulation’s (DPR) renewal of the registration for methyl bromide, a fumigant pesticide. EPA concluded in that action that there was support for “a preliminary finding of a prima facie Title VI violation,” and EPA and DPR entered a settlement agreement in 2011.
Petitioner argued that EPA’s findings in Angelita C., and evidence that it claimed to demonstrate that pesticide use had not gone down since EPA completed its original review, supported the claimed Title VI violations that are the subject of the Ninth Circuit petition, and further that EPA did not do enough to determine that California had satisfied its burden to provide assurances of compliance with federal law. The Ninth Circuit decision states in this regard that the petitioner “effectively contends the EPA should have evaluated California’s assurances the same way the EPA would have to deal with a pending Title VI complaint setting forth allegations of a current violation.”
The court states: “El Comite’s argument fails because it misconstrues the EPA’s burden regarding the ‘necessary assurances’ requirement. The EPA has a duty to provide a reasoned judgment as to whether the state has provided ‘necessary assurances,’ but what assurances are ‘necessary’ is left to the EPA’s discretion.” The court further found: “El Comite provided no proof of a current or ongoing violation. It merely provided evidence of the earlier violation, and pointed to continued pesticide use since that time. The EPA explained that this evidence failed to draw any connection between the proposed rules and a potential disparate impact. The EPA fulfilled its duty to provide a reasoned judgment because its determination was cogently explained and supported by the record.”
The decision in this case is of significant interest to many who have been observing the emerging trends regarding environmental justice issues arising in connection with pesticide applications. This concern may grow larger as EPA continues and expands its evaluations of the potential bystander risks from pesticide use, potentially leading to additional restrictions for certain pesticides in the future.
By Lynn L. Bergeson and Carla N. Hutton
Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition. In general, the response does not alter EPA’s legal position with regard to nanosilver and its regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or otherwise contribute any new interpretations of existing EPA pesticide registration or enforcement policy.
Briefly, the key decisions articulated in EPA’s response to the petition are:
* EPA will treat products containing nanosilver as pesticides under FIFRA if intended for pesticidal purposes, even in the absence of explicit pesticidal claims.
* EPA rejected ICTA’s claim that all products containing nanosilver are categorically pesticides and should be regulated as such.
* EPA will continue to apply its statutory and regulatory criteria as to what is a pesticide on a case-by-case basis. The determination “would be fact specific, typically based upon information on the use patterns intended, the claims or other advertising used to distribute or sell the ingredient or product, and any other information or knowledge made known to or known by the distributor or seller.”
* Importantly, EPA disagrees with ICTA’s claim that the treated article exemption should not apply to any nanosilver pesticide product because nanosilver specifically is not the registered pesticide active ingredient. According to EPA, application of the treated article exemption is available if a registered pesticide product is used, consistent with any terms and conditions of use of the registered product.
* EPA granted ICTA’s request to review the health and safety impacts from use of a nanosilver ingredient in a pesticide product based on nanosilver data for the portion released as nanosilver and based on macro-scaled silver for the portion released as silver ions, and agrees that FIFRA Section 3(c)(7)(C) is the appropriate authority for review of applications for registration of products containing nanosilver ingredients.
* EPA rejected ICTA’s claim that EPA must comply with the National Environmental Policy Act (NEPA) to assess the environmental impacts of EPA’s decision regarding nanopesticides, citing EPA’s well-settled view that it is exempt from NEPA requirements under FIFRA under Merrell v. Thomas, 807 F.2d 776 (9th Cir. 1986).
* EPA denied ICTA’s request to use a particular enforcement strategy to address unregistered pesticides sold or distributed in the U.S., believing that EPA lacks a factual basis to conclude that all nanosilver products are pesticides and thus does not have the legal basis upon which to conclude that all products are illegally sold or distributed.
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.