What You Need to Know
- Key takeaway #1For the first time in nearly 40 years, EPA issued an emergency suspension order immediately banning the sale, distribution, and use of a pesticide, this time affecting all registrations of pesticide products containing DCPA, an active ingredient in pesticides used for weed control.
- Key takeaway #2This action may signal EPA’s renewed interest in using FIFRA’s Section 6 authority to issue emergency suspensions for other controversial or potentially harmful active ingredients in the future.
- Key takeaway #3EPA must meet a heightened burden and follow proper procedures under FIFRA and relevant case law in order to issue emergency suspensions and eventually cancel the subject registrations.
EPA’s Rare Emergency Action
On August 6, 2024, the Environmental Protection Agency (“EPA”) took the rare action of announcing the emergency suspension of all registrations for pesticide products containing the active ingredient dimethyl tetrachloroterephthalate (“DCPA” or “Dacthal”) under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). This is the first time in almost 40 years that EPA has issued an emergency suspension order.[1] EPA’s reasoning for the present action is that DCPA can cause adverse health effects in the fetuses of women exposed to DCPA.
By invoking its emergency suspension authority, EPA did not provide any opportunity for a public hearing before issuing the order. This emergency order is effective immediately, and the terms of the order immediately prohibit the distribution or sale of any pesticide product containing DCPA, as well as the use of any existing stocks of such pesticides. EPA will allow distribution of existing stocks of DCPA solely for the purpose of returning any products containing DCPA to the registrant.
As stated in EPA’s order, “in order to find an ‘imminent hazard,’ the Agency must determine that the risks appear to outweigh the benefits associated with continued registration during the period likely to be necessary to complete a cancellation proceeding.” To meet the statutory standard for such suspensions, discussed in Love v. Thomas[2] (see below), and to address potential challenges by the registrant or other interested parties, EPA’s order contains a “rough” balancing of health risks against economic benefits for all currently registered uses of DCPA. EPA concluded that DCPA’s main benefits relate to its broad spectrum weed control for brassicas and alliums, noting that these crops are vulnerable to early season weed competition. Moreover, DCPA has high benefits for growers of specialty brassica crops (e.g., bok choy, collards, and kale), for which there are fewer registered alternative herbicides.
However, EPA identified negative health effects for fetuses of pregnant women exposed to DCPA and concluded that the health risks of DCPA outweigh the economic impact to growers and consumers. In its balancing of the costs and benefits of the suspension, EPA asserted that, “[t]hough growers of Brassica and Allium crops may be substantially impacted, these crops are internationally traded, and the global price is unlikely to increase[, so] growers will be unable to pass cost increases on to the consumer, thus this Emergency Order is likely to result in negligible impact at the consumer level.” EPA’s order states that growers can identify and obtain alternatives to DCPA.
Standard for Emergency Action Under FIFRA Section 6
EPA must meet a heightened burden and follow proper procedures under FIFRA in order to issue emergency suspensions. EPA can only suspend a pesticide based on its risks if the suspension “is necessary to prevent an imminent hazard during the time required for cancellation … proceedings.”[3] As relevant here, FIFRA defines “imminent hazard” as a situation where “the continued use of a pesticide during the time required for cancellation proceedings would be likely to result in unreasonable adverse effects on the environment,” which, as with other decisions under FIFRA, “tak[es] into account the economic, social, and environmental costs and benefits of the use of [the] pesticide.”[4] Thus, in order to find an “imminent hazard,” EPA must establish that the risks of a pesticide outweigh the benefits of continued use during the time necessary to complete a cancellation proceeding.
Additionally, under 7 U.S.C. § 136d(c)(3), EPA can only suspend the registration of a pesticide without providing advance notice and opportunity for a hearing if an emergency exists and the agency issues a notice of intent to cancel the product within 90 days. Although FIFRA does not define an “emergency,” it is generally read as harm occurring during the period required for a suspension hearing.[5] EPA has determined that, due to the imminent harm posed by DCPA, an emergency exists; it has suspended DCPA registrations under these provisions; and it intends to issue a notice of intent to cancel the DCPA products within 90 days, or by November 5, 2024.
In the case of an emergency suspension, the suspension order takes effect immediately and is in force pending any hearing on the appropriateness of the suspension. If the registrant were to request an administrative hearing, challenging the suspension, such hearing would be limited to the question of whether an imminent hazard exists. However, “[a]ny order of suspension entered prior to a hearing before the Administrator,” such as the DCPA emergency order, is subject to immediate judicial review in federal court “solely to determine whether the order of suspension was arbitrary, capricious or an abuse of discretion, or whether the order was issued in accordance with the procedures established by law.” 7 U.S.C. §§ 136d(c)(4), 136n. Love v. Thomas, discussed below, illustrates judicial review of an EPA emergency order and sheds light on the considerations relevant to finding an imminent hazard.
Caselaw Highlights the Heightened Standard for Emergency Suspensions
EPA’s previous use of the emergency suspension provision of FIFRA was challenged by farmers and food processors in Love v. Thomas. In October 1986, EPA issued an emergency suspension order, pursuant to FIFRA section 6(c)(3), preventing any further sale, distribution, or use of pesticide products containing dinoseb pending the completion of the cancellation proceedings.[6] EPA reasoned that preliminary studies indicated that exposure to dinoseb may cause health risks, including sterility and birth defects.
The Ninth Circuit disagreed with EPA’s actions in issuing the emergency suspension order. The court explained that an “imminent hazard” exists “if there is substantial likelihood that serious harm will be experienced during the year or two required” for the full cancelation proceedings.[7] As noted above, such a finding requires consideration of both the risks and benefits of the use of the pesticide. The court found that EPA did not give itself sufficient time to comply with the FIFRA requirement that the agency balance risk and benefits in reaching such a conclusion. It concluded that EPA did not fully investigate the economic effects and therefore could not perform “even a rough and ready balancing.” Instead, EPA relied on incomplete data, and conducted only a cursory evaluation of the availability of alternative pesticides and the economic impact of the suspension.[8] In light of these findings, the Ninth Circuit held that EPA’s suspension order was arbitrary, capricious, an abuse of discretion, and was not issued in accordance with the provisions of FIFRA.[9]
Other cases have reviewed which factors EPA must consider when determining whether an emergency exists to justify an emergency suspension. In Dow Chem. Co. v. Blum, the U.S. District Court for the Eastern District of Michigan concluded that EPA must consider the following factors:
- the seriousness of the threatened harm;
- the immediacy of the threatened harm;
- the probability that the threatened harm will occur;
- the benefits to the public of the continued use of the pesticide; and
- the nature and extent of the information before EPA at the time it makes a decision.[10]
There, the court upheld emergency suspension orders because EPA considered each of the relevant factors and its conclusions on such issues were supported by facts and did not constitute clear errors of judgment.
EPA’s DCPA emergency suspension order acknowledges Love v. Thomas and Dow Chem. Co. v. Blum, stating that “courts interpreting the FIFRA section 6 suspension standard have made clear that an imminent hazard finding requires a greater degree of likelihood, immediacy, and severity of harm than is otherwise required to take cancellation action under FIFRA.” EPA’s order discusses each of the considerations identified by the Dow court and determines that, based on such considerations, continued use of DCPA poses an emergency during the time required for a suspension hearing.
Potential Future FIFRA Section 6 Emergency Suspensions
The DCPA emergency suspension order sends a message: EPA has not forgotten about or given up on its emergency suspension authority. When the identified conditions are met, EPA will not merely seek changes to a products label or, failing that, participate in lengthy cancelation proceedings; the agency is still (or once again) willing to issue immediately effective suspensions. Pesticide registrants should be aware of this development as they engage with EPA regarding risk concerns for other active ingredients that may be subject to scrutiny. With this emergency action breaking a nearly 40-year streak, EPA may be emboldened to use its suspension and cancelation authority again going forward. Such suspensions, however, may, as in the past, be subject to intense litigation and scrutiny.
For further information, please contact:
Warren Lehrenbaum, Partner, Crowell & Moring
wlehrenbaum@crowell.com
[1] Although this is the first time in recent history that EPA has suspended a pesticide based on an imminent hazard, EPA has repeatedly suspended pesticides based on failures to submit required data. Such suspensions are subject to different standards and do not lead to cancelation proceedings.
[2] 858 F.2d 1347, 1361-62 (9th Cir. 1988).
[3] 7 U.S.C. 136d(c)(1).
[4] 7 U.S.C. 136(bb).
[5] See EPA Order, citing Dow Chem. Co. v. Blum, 469 F.Supp. 892, 901 (E.D. Mich. 1979).
[6] 858 F.2d 1347 (9th Cir. 1988).
[7] Id. at 1350 n.3.
[8] Id. at 1358-61.
[9] Id. at 1363.
[10] See EPA Order, citing Dow Chem. Co., 469 F.Supp. at 902.