Government Shutdown Averted: What's Next?
Last weekend, Congressional negotiators approved a 47-day stopgap bill that funds the government through November 17 thereby avoiding a government shutdown. The bill, called a continuing resolution (CR) was signed shortly after that by President Joe Biden. The CR funds government at current levels until a fiscal year 2024 federal budget is approved.
For CPDA members, this means that EPA’s handling of PRIA and non-PRIA submissions can continue at current levels.
This also means that the Congressional Agriculture Committees can resume work on a new Farm Bill. This doesn’t mean, however, that agriculture can expect a new Farm Bill by the end of the year. There’s a lot on the Congressional plate that will likely push Farm Bill discussions to the side. This includes:
- There are no scheduled markups or hearings in either the House or Senate Agriculture Committees. They have work to do before they are ready for a full House and Senate vote.
- The CR did not include any military funding for Ukraine, which is a source of contention for both Democrats and Republicans.
- The measure does not include any funding for border protection – another source of contention among the parties.
Complicating all this was the successful effort by Rep. Matt Gaetz (R-FL) to remove House Speaker Kevin McCarthy. On Monday, Gaetz introduced a motion asking House members to vote on whether the office of the Speaker of the House should be “vacant.” On Tuesday evening, McCarthy was ousted as Speaker by a 216-210 vote. That leaves the House without a Speaker until next week, at the earliest, as House members will try and elect a new Speaker.
Overlaying this political battle is the need for Congress to restart the appropriations process. Given all this, it seems extremely unlikely that the Ag Committees will finish up a Farm Bill and get Congressional leaders to agree on scheduling a floor vote for final approval in either the House or Senate before November 17. The most likely scenario at this point is a Farm Bill that stretches into 2024.
OPP struggles with IT problems & we all suffer
EPA’s aging IT system for receiving and processing PRIA submissions has been plagued repeatedly by problems, breakdowns, and contract disputes for more than a year. With a wholesale IT upgrade in progress, EPA has been reluctant to patch up the old system, resulting in a significant drag on PRIA 5 implementation, even creating new backlogs where they didn’t already exist. Installation of “Sales Force” software by all OPP divisions was scheduled for completion by the end of September (Fingers crossed). Registrants’ ability to track action on their own submissions in real time is to be part of the IT upgrade, but that feature is a way off yet.
Communications from EPA about the nature, timing, and extent of IT problems affecting PRIA (and non-PRIA) submissions have been haphazard at best. The Agency seems to learn more from registrants about the problems than we do from them. The PRIA Coalition of registrant trade associations are contemplating letters to OPP, EPA’s Office of Inspector General (OIG), and Congress to seek clarity and meaningful action to resolve the problems.
This is a list of some problems observed by CPDA members and others in industry. I welcome and encourage your input to better inform communications by the PRIA Coalition to OPP, OIG, and Congress. Is your company experiencing similar problems or others that are not listed here? Please respond to me in the next week – I’ll keep your responses confidential.
EPA is not processing the Notices of Supplemental Distribution of a Registered Pesticide Product (Form 8570-5). This is a “non-PRIA” action that technically doesn’t require approval, but many states request the official notice of the ‘stamped acknowledgement’ from EPA. Hence, a large backlog is preventing distributors from obtaining state registrations.
- Delays in registering new products under PRIA are throwing data compensation into disarray. An offer to pay must be made at the time of application. But when the application sits in a queue for months without processing, the whole process for determining the proper date for compensability of data is upended, putting follow-on registrants at a major competitive disadvantage.
- Many if not most PRIA submissions since early July have not been assigned their respective decision review dates, due to “front end” problems. One OPP Division Director cautions that this will add 3 to 6 months or more to all PRIA actions, regardless of delays for other reasons.
- Gold Seal letters for export of pesticide products have virtually dried up.
Many stamped approved labels have not been posted to EPA’s Pesticide Product Label System (PPLS), which states use as evidence of EPA registration and approval of label amendments.
EPA Denies Petition for Formulation & Mixture Testing
In 2017, the Center for Food Safety (CFS) filed a petition asking EPA to initiate rulemaking to establish new testing requirements to evaluate and assess pesticide formulations and mixtures when registering pesticides. This includes an evaluation of tank mixes and inert ingredients as well as adjuvants added to spray tanks. The petition asserted that EPA does not adequately assess the environmental impact from use of pesticide products or tank mixes as most of EPA’s data requirements pertain to the pesticide’s active ingredient.
In response to the petition, EPA opened a public comment period in December of 2018. Following the comment period, EPA did not initiate rulemaking as the petition requests. As a result, CFS and three other organizations filed suit last October asking the U.S. District Court for the Northern District of California to, among other things, force EPA to respond to the 2017 Petition within 90 days of the decision. On September 29, EPA formally announced its response to the CFS petition by denying it.
While this closes the books on the CFS petition, the story probably doesn’t end here. What’s next is a likely CFS lawsuit seeking to force EPA by court order to assess pesticide formulations and mixtures in its approval process and to prohibit the use of mixtures until the testing and evaluation of the data are complete.
EPA’s denial of the petition is rooted in the U.S. regulatory process. Pesticides and mixtures are regulated through a process that is robust, meticulous, and demanding. Under current law, EPA conducts a thorough, multi-year review examining hundreds of studies to ensure that each pesticide will perform as intended without causing adverse effects to human health, non-target species or the environment. This rigorous regulatory process is the global gold standard and is copied throughout the world.
CPDA will continue to monitor this issue as the implications for formulations, inert ingredients and adjuvants are far-reaching and severe.