CPDA continues to work with EPA and allied industry trade associations urgently seeking a resolution to the shortage of the active ingredient 1,2-benzisothiaxolin-3-one (BIT). Preservative products containing BIT are used in the formulation of hundreds of agricultural pesticide products by many registrants. The precursor chemical o-nitrochlorobenzene, essential to the manufacture of BIT products, is sourced almost exclusively from China. BIT can serve as both an active ingredient or an inert ingredient depending on whether or not it has a pesticidal effect when used in a registered end use product.
Over this past summer, the Chinese government, as part of its anti-pollution Blue Sky initiative, shut down key BIT and BIT precursor manufacturing operations pending the results of ongoing environmental site inspection of these facilities. These closures have led to inventory shortages of BIT and BIT precursor products which has adversely impacted a number of pesticide formulation operations. Some registrants have been notified by their suppliers that they will be unable to fulfill their long-standing supply contracts. CPDA received reports from companies that the BIT shortage is seriously impeding their ability to find alternate sources of these products, thus creating the potential for major manufacturing disruptions as registrants prepare for the 2019 growing season.
In response, CPDA and allied trade associations have engaged with EPA personnel in an effort to address this situation, requesting that the Agency approve a streamlined self-certification process, in lieu of submitting an amended Confidential Statement of Formula (CSF), for impacted end use products for which an alternate supply of BIT is used. The trade association coalition gathered feedback from their respective member companies in order to develop a list of possible alternatives to BIT for use in pesticide formulations. This has been presented to EPA for review and approval.
On August 23, 2018, EPA sent a letter to the industry coalition agreeing to a time-limited self-certification process, not to exceed 24 months, whereby registrants could notify the Agency of a change in the source of BIT without having to submit an amended CSF. For each end use product in which BIT is used as an active ingredient, registrants are directed to submit a Formulator’s Exemption form (EPA Form 8570-27) as described in PR Notice 98-10. For products where BIT is used as an inert ingredient, EPA will allow notification of the source change to be submitted in the form of a single letter which covers all impacted products. EPA states that at the end of the 24-month period, barring any evidence of continued market instability due to extended BIT shortages, the Agency will require the submission of new or amended CSFs for which the source of BIT has changed from what is listed in the current CSF. Submissions would be required within 90 days of August 23, 2020 or upon the identification of “stable source(s),” whichever is earlier.
While the streamlined process of notification set forth by EPA is limited to seven specific alternate registered sources of BIT as listed in the August 23rd letter, CPDA has learned that this list will likely be expanded and that an update will be released by the Agency shortly. In the meantime, CPDA and other members of the industry coalition continue to collaborate with EPA on this issue in an effort to avert the looming crisis that could unfold during the 2019 growing season in the face of continued shortages of BIT.