By Lisa M. Campbell and Susan Hunter Youngren, Ph.D.
The U.S. Environmental Protection Agency (EPA) issued an updated schedule for the Pesticide Registration Review program that sets forth a timetable for opening dockets for the next three years, through end of fiscal year 2017 (September 2017).
Through the Pesticide Registration Review program, EPA reviews all registered pesticides at least every 15 years, as mandated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Following the newly issued schedule, all pesticides registered as of October 1, 2007, will have entered the registration review process with the exception of certain biopesticides. All pesticides registered by October 1, 2007, are scheduled to be assessed by October 1, 2022.
The rodenticide and triazole groups of chemicals have had their schedules adjusted so that all chemicals in the groups will be assessed during the same time frame. The rodenticides have dockets opening in first and second quarter 2016, while the triazoles have dockets opening from fourth quarter 2015 through third quarter 2016. In addition, EPA states that it has moved some chemicals that it believes may have significant data needs earlier in the schedule, but does not specify which were moved. Those with significant moves forward in the schedule (all moved from fourth quarter 2015 to first quarter 2015) include yellow mustard seed, sulfonic acids, fluazifop butyl, isomers, and flonicamid.
More information about the Pesticide Registration Review schedule is available here.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
Center for Food Safety v. EPA is a case in the U.S. Court of Appeals for the 9th Circuit (9th Circuit) that consolidates two petitions for review of a decision by the U.S. Environmental Protection Agency (EPA) to register the new herbicide product Enlist Duo for use in six Midwestern states. A group of non-governmental organizations filed one of the petitions and the Natural Resources Defense Council (NRDC) filed a separate petition. Enlist Duo combines the active ingredients glyphosate and 2,4-D. The registrant Dow AgroSciences (Dow) has intervened in the case. The petitioners focus primarily on the purported failure of EPA to consider properly the effects of Enlist Duo on certain endangered species.
Each petitioner has now filed a motion to stay the EPA action registering Enlist Duo due to Endangered Species Act (ESA) challenges. The first stay motion filed by NRDC is based primarily on the risk to monarch butterflies, and that stay motion has now been fully briefed. The other petitioners filed a separate stay motion focusing on whooping cranes and Indiana bats, but they waited until two weeks after EPA and Dow filed their briefs opposing the first stay motion. Before either stay motion was filed, Dow filed a motion seeking transfer of the case to the D.C. Circuit Court of Appeals. Arguing that the two independent successive stay motions were abusive, Dow later filed a motion to hold the briefing on the second stay motion in abeyance, pending a ruling on its transfer motion.
The 9th Circuit denied Dow’s motion to hold the briefing on the second stay motion in abeyance only three days later. This procedural ruling does not dispose of the underlying transfer motion, but it does suggest that the court is not inclined to transfer the case. If the case is not transferred, the court will ultimately consider and rule on both pending stay motions. The court’s interim order does not suggest how it views the pending stay motions. The petitioners have a heavy burden to show both a substantial likelihood of success on the merits and irreparable harm to obtain the requested interim relief. EPA and Dow contend that the petitioners have not established either of these things. Overall, this ESA challenge to a new genetically modified organism (GMO) product may indicate a new front in the ESA litigation arena, since new products have generally not been challenged under ESA requirements. 2,4,-D itself is not a new herbicide, so this case is not quite a challenge to a totally new active ingredient; such a challenge was made recently in the case of cyantraniliprole. CBD, et al. v. EPA, No. 14-00942 (D.D.C. filed Oct. 10, 2014). Challenges to new active ingredients and GMO products, however, could threaten to hinder the introduction of new products into the marketplace.
By Lisa R. Burchi
The California Department of Pesticide Regulation (DPR) has extended, from February 27, 2015, to Friday, March 13, 2015, the submission of written comments following DPR’s January 14, 2015, Registration Fee Workshop where DPR discussed the potential increase in registration fees for pesticide products pursuant to Food and Agricultural Code (FAC) § 12812(a).
Under the proposal, DPR would increase fees for applications and renewals from $750 to $1,150, decrease fees for certain label amendments supported by scientific data from $100 to $25, and create a new fee of $25 for label amendments not supported by scientific data, including substantive label amendments, non-substantive label amendments, label changes required by the U.S. Environmental Protection Agency or any other federal or state agency, amendments to the formulation of the pesticide product, and notifications.
By Lisa M. Campbell and James V. Aidala
On January 28, 2015, the U.S. Environmental Protection Agency (EPA) announced that it has made available for public comment its proposal to improve the corn rootworm insect resistance management program currently in place for registrations of plant-incorporated protectants (PIP) derived from Bacillus thuringiensis (Bt) in corn. The EPA framework contains a number of controversial provisions, including the following proposed restriction of soil applied insecticides (SAI): “SAIs must be prohibited from use in combination with Bt corn for controlling corn rootworm. This can be done via bag tag language, grower guides, and terms of registration.” Concerns with the process by which this and other provisions can or should be developed and published for public comment are among the issues of concern. Comments are due March 16, 2015.
By Lisa R. Burchi
The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements for Chemical Active Substances and Plant Protection Products according to Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013. Following the adoption in 2009 of Regulation (EC) No. 1107/2009 concerning the placing of plant protection products (PPP), additional regulations were adopted to establish the necessary data requirements for active substances and PPPs. In 2013, Regulation (EU) No. 283/2013 (amended by Regulation (EU) No. 1136/2014) updated the data requirements for active substances, while Regulation (EU) No. 284/2013 updated data requirements for products. These Regulations include transitional measures to explain when certain applications can rely upon former data requirements and when the updated data requirements must be satisfied.
The Guidance provides two charts describing the transitional measures for: (1) applications for approval, renewal, or approval or amendment of approval of Active Substances; and (2) applications for authorization, renewal of authorization, or amendment of authorization of Plant Protection Products. Each chart describes the type of application at issue and the resulting data requirements. For authorization applications, the Guidance divides the types of applications and resulting data requirements into four active substances categories: (1) AIR-2 active substances; (2) AIR-3 active substances/substances not yet renewed; (3) new active substances; and (4) mixtures.
The Guidance was developed to assist EU Member States in consistently applying and interpreting these transitional measures. Many of the data requirement decisions depend on the type of active substances and whether an application is submitted before or after December 31, 2015, so companies considering or planning to submit applications should review the Guidance carefully to determine what data requirements may be applicable.
By Lisa R. Burchi
On January 27, 2015, the European Union (EU) Standing Committee on Plants, Animals, Food and Feed agreed to a proposed list of 77 pesticide active substances to be classified as Candidates for Substitution (CFS). The draft list of CFS is available online. A Question and Answer (Q&A) document regarding the CFS list is available online. Additional information regarding the proposed list is also available online.
This list is an important and long-awaited development under the Plant Protection Product (PPP) Regulation (EC) No. 1107/2009. The Standing Committee clarifies that the CFS active substances are not banned and that approved CFS active substances will remain on the EU market, although there are potentially significant consequences for those listed active substances. Most challenging is the requirement that Member States do the following for new applications for authorization of PPPs containing CFS active substances that are submitted after August 1, 2015: (1) conduct a comparative assessment when evaluating an application for authorization for a PPP containing an active substance approved as a CFS; and (2) not authorize or restrict the use of a PPP containing a CFS for use on a particular crop where the comparative assessment weighing up the risks and benefits demonstrates that safer alternatives exist. In addition, substances not evaluated by the Standing Committee (e.g., substances approved after January 1, 2013) can be identified as a CFS under Article 24 of the PPP Regulation. In those cases, any approval will be limited to a maximum of seven years, compared to 10 or 15 years for other active substances.
The next step will be review and adoption of the CFS list by the European Commission, and then publication of the list as a Commission Regulation in the Official Journal.
By Sheryl Lindros Dolan
On December 16, 2014, the U.S. Environmental Protection Agency (EPA) will host a half-day workshop on the application process for the use of inert ingredients in pesticide products. The workshop will take place in Arlington, Virginia. The goal of the workshop is to clarify the necessary elements of an application for approval to use an inert ingredient in a pesticide product. Complete application packages save applicants time and money, and reduce the number of application rejections. The workshop will cover: selection of a Pesticide Registration Improvement Act (PRIA) category, elements of an application, EPA’s evaluation process, and a retrospective review of inerts under PRIA. EPA will answer stakeholder questions throughout the workshop.