When we explained in our last blog post the recent Court of Appeals decision that vacated the registration of three dicamba-based products, we mentioned that one possibility for answering the “what happens now” question was for the EPA to issue a cancellation order that would allow use of existing stocks of the products held by end users. That’s exactly what happened yesterday, when the US EPA made a final order that cancelled the registrations of XtendiMax, Engenia, and FeXapan but allows for movement and use of the products. Here’s a summary of the agency’s order.
Authority to issue the cancellation order
After reviewing the background of the dicamba product registrations vacated by the Ninth Circuit Court of Appeals last week for lack of “substantial evidence” supporting the registrations, the EPA stated that it was relying upon the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to establish provisions for the disposition of existing stocks of registrations that are found to be invalid. “The Administrator may permit the continued sale and use of existing stocks of a pesticide whose registration is suspended or canceled under [sections 3, 4 or 6 of FIFRA] to such extent, under such conditions, and for such uses as the Administrator determines that such sale or use is not inconsistent with the purposes of [FIFRA]” stated the agency.
The EPA noted that FIFRA does not prohibit the use of unregistered pesticides, but only prohibits the sale and distribution of unregistered pesticides. The agency noted that without its action, end users holding stocks of the products aren’t prevented from using the stocks without following label directions and restrictions. And the agency pointed to a similar action it took after a 2015 court order that vacated the registration of sulfoxaflor and a 2010 court decision that vacated the registration of spirotetramat. In both cases, the EPA utilized a cancellation order to establish terms and conditions for the disposition of existing stocks of the products.
Existing Stocks Determination
The EPA established an “existing stocks policy” in 1991 to help the agency assess how to treat existing stocks of cancelled pesticides, both when no significant risk concerns have been identified and when there are significant risk concerns for a cancelled product. The agency noted that it considered the six factors outlined in the policy for considering significant risk concerns associated with a cancelled pesticide and reached the conclusion that “distribution and use in certain narrow circumstances is supported.”
The six factors the agency considered in determining what to do with the existing stocks of dicamba products are:
- Quantities of existing stocks at each level of the channels of trade
The agency noted that due to the current timing of the growing season, significant existing stocks are present in the possession of end users and throughout the channels of trade. Stating that it couldn’t determine the exact quantities of existing stocks at each level of the channels of trade, the EPA estimates that “approximately 4 million gallons could be in the channels of trade.”
- Risks resulting from the use of the existing stocks
Again concluding that because the product registrations were vacated and the labels therefore voided, end users were not legally bound to follow label restrictions if using the dicamba products. The agency concluded that such non-label uses would have greater potential for adverse effects than if the agency issued an order regulating the use of the existing stocks. Such an order is imperative, said the agency, to ensure that any use of the products would be consistent with previously approved labeling and can be enforced in order to prevent unreasonable adverse effects on the environment. Surprisingly, the EPA gave little attention to the volatility concerns raised by the Ninth Circuit in its decision last week, and evidence the court pointed to in that case that suggested that even applications by those who carefully followed the label restrictions were subject to drift and damage.
- The benefits resulting from the use of existing stocks
Capitalizing on the unfortunate timing of the Ninth Circuit’s vacation of the pesticide in regards to planned immediate uses in the current growing season, the agency concluded that “the benefits resulting from the use of the products are considerable and well established, particularly for this growing season.” The EPA reiterated many of the numerous communications it had received stating how essential the over-the-top products are, especially with the growing season underway. It also concluded that allowing non-over-the-top uses would result in substantially greater benefits to users and society than would disposal of the products.
- The financial expenditures users and others have already spent on existing stocks
Again pointing to the current growing season, the agency concluded that “the costs to farmers are not limited to their existing stocks of these dicamba products, but include other sunk costs made in expectation of the availability of these products (seed purchase, tilling, planting, etc.) as well as the lost opportunity to switch to a different crop or to another herbicide or weed management method.”
- The risks and costs of disposal or alternative disposition of the stocks
The EPA concluded that disposal of the existing stocks of dicamba products would incur substantial costs for all and, for stock already in the hands of end users, “may be neither feasible nor advisable.” Additionally, the agency pointed to disposal or return of opened containers which would have high risks of spillage and increased expenses for proper disposal.
- The practicality of implementing restrictions on distribution, sale, or use of the existing stocks
Another option available to the agency under FIFRA would be to issue individual stop sale, use and removal orders to all end users holding dicamba products, but the EPA concluded that such an action would be unwarranted under the present facts because tracking the existing stocks would be burdensome, inaccurate and impractical and that “hard-pressed farmers who have made large investments in their existing stocks may be uncooperative with a cancellation order that requires disposal.”
After weighing the six factors above, the EPA concluded that the six factors weigh heavily in support of allowing end users to use existing stocks of the dicamba products in their possession. However, the agency imposed a July 31 , 2020 cut-off date for use of existing stocks in order to “further reduce the potential for adverse effects.” Here are the final orders the agency made for the products:
- Distribution or sale by the registrant. Distribution or sale by the registrant of all existing stocks of the products listed below is prohibited effective as of the time of the order on June 3, except for distribution for the purposes of proper disposal.
- Distribution or sale by persons other than the registrant. Distribution or sale of existing stocks of the products listed below that are already in the possession of persons other than the registrant is permitted only for the purposes of proper disposal or to facilitate return to the registrant or a registered establishment under contract with the registrant, unless otherwise allowed below.
- Distribution or sale by commercial applicators. For the purpose of facilitating use no later than July 31, 2020, distribution or sale of existing stocks of products listed below that are in the possession of commercial applicators is permitted.
- Use. Use of existing stocks of products listed below inconsistent in any respect with the previously-approved labeling accompanying the product is prohibited. All use is prohibited after July 31, 2020.
While the manufacturers of XtendiMax, Engenia, and FeXapan are prohibited from selling and distributing their products effective as of June 3, 2020, the EPA’s cancellation order allows others to return, dispose of, or use the products according to the previous label restrictions and no later than July 31, 2020. But a few other factors come into play:
- Some states have already taken actions to restrict the use of the dicamba products, which is within a state’s authority. Ohio has not done so, and instead has stated that it has been awaiting US EPA guidance on the legal status of the products and will communicate options for farmers afterwards. This means that users in Ohio should keep a close eye on the Ohio Department of Agriculture to see if it will go along with the US EPA’s guidance or direct otherwise.
- A cancellation order issued by the EPA is a final agency action that is subject to appeal, so we might see an immediate of the cancellation order and a request to stay the order pending appeal. Such an appeal could challenge whether the EPA has the authority to regulate existing stocks of the products and whether the agency’s analysis sufficiently addressed the risks of adverse impacts from continued use.
As seems often to be the case with dicamba, there’s a mixed sense of drama and dread with what lies ahead. We’ll be sure to keep you posted on the next legal news for dicamba.
Read the US EPA’s cancellation order for XtendiMax, Engenia, and FeXapan here.