Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On August 11, 2015, the U.S. Court of Appeals for the Ninth Circuit denied a motion for a stay pending review filed on December 18, 2014, by the Natural Resources Defense Council (NRDC), as well as a subsequent stay motion filed on February 6, 2015, by the Center for Food Safety and other petitioners (Case Nos. 14-73353 and 14-73359, consolidated).  Both motions requested that the court stay an October 15, 2014, decision by the U.S. Environmental Protection Agency (EPA) to register Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on corn and soybeans in six Midwestern states.

NRDC and CFS, et al. (Petitioners), filed these stay motions in a case consolidating petitions for review challenging EPA’s decision to register Enlist Duo.  The registrant of Enlist Duo (Dow AgroSciences) has intervened in the consolidated case.  The Petitioners argue that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D.  In response, both EPA and Dow AgroSciences argue that approval of Enlist Duo will not lead to increased use of glyphosate, and that EPA fully considered all of the human health effects of 2,4-D before granting the registration.

The motions for a stay filed by the Petitioners were effectively motions for preliminary injunctive relief, an extraordinary remedy requiring that those seeking such relief show that they are likely to succeed on the merits, that there is likely to be irreparable harm, that the balance of equities tips sharply in their favor, and that an injunction is in the public interest.  In denying the stay motions, the court cited Winter v. NRDC, 555 U.S. 7 (2008).  In the Winter case, the Supreme Court held that irreparable injury must be likely and that a mere possibility of irreparable injury will not suffice in awarding injunctive relief.  Although the court did not opine further on its rationale for denying the Petitioners’ stay motions, it may be inferred that the court determined that the Petitioners had not satisfied the rigorous prerequisites for injunctive relief.

While this decision avoids an immediate disruption in the marketing of pesticides, the potential for disruption to the registration remains until the court challenge has been resolved.  As Enlist is a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D, any disruption now would be especially impactful to the registrant and customers of the product.  Further, it could also have a chilling effect on efforts to introduce similar new or pending products if growers perceive too great a risk of uncertainty for this or similar pesticides.

 


 

By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

In an opinion issued on August 10, 2015, the U.S. Court of Appeals for the Ninth Circuit granted a writ of mandamus requested by Pesticide Action Network North America and the Natural Resources Defense Council (Petitioners) to require that the U.S. Environmental Protection Agency (EPA) act in response to a 2007 administrative petition to cancel the registrations of all pesticides containing chlorpyrifos.  A writ of mandamus to compel administrative action is an extraordinary remedy and is generally reserved for instances of egregious delay.  The same court had previously declined to grant mandamus to the same Petitioners in 2013, but has now concluded that mandamus is the only way to end a “cycle of incomplete responses, missed deadlines, and unreasonable delay.”

After the Petitioners commenced the current case, EPA issued a preliminary decision indicating that it intended to deny the petition to cancel chlorpyrifos, and told the court that it would take final action after reviewing public comments by the summer of 2015.  In a status report subsequently filed in response to a June 10, 2015, order by the court, EPA changed course and stated that unresolved concerns about the risk associated with chlorpyrifos levels in some drinking water might warrant a rulemaking to revoke all existing chlorpyrifos tolerances.  EPA stated that it intended to commence such a rulemaking in April, 2016, unless the registrants of chlorpyrifos products agree to make labeling changes to mitigate the risk from residues in drinking water.  The Petitioners were not satisfied with this amorphous response by EPA, and the court has now agreed.

The writ of mandamus directs EPA to issue a proposed or final rule to revoke chlorpyrifos tolerances, or a full and final response to the administrative petition to cancel chlorpyrifos, no later than October 31, 2015.  If EPA elects to issue a proposed revocation rule, EPA must inform the court by October 31, 2015, of the timeline for finalizing the proposed rule.  Meeting this specific directive from the court will be very challenging.  EPA must determine quickly whether the registrants of chlorpyrifos products will agree to label changes that EPA considers sufficient to mitigate drinking water risks.  Such label changes could hypothetically obviate the need for a tolerance revocation rule and provide a basis for a final decision by EPA to deny the petition to ban chlorpyrifos.  Otherwise, EPA will need to substantially accelerate its stated timetable for issuing a proposed rule to revoke chlorpyrifos tolerances.

In brief, this commitment by EPA will accelerate discussions with the registrant and user groups in an attempt to resolve the issues identified in EPA’s assessment.  It appears that this will compress a process which has typically taken many months into a much tighter time frame, to comply with the court’s order.  That obviously was among the goals of the plaintiffs in the case; it remains to be seen how doing so will affect the EPA’s ability to evaluate the risks and benefits of the pesticide as fully as it typically has done in the past. 


 

By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.

Along with the release of the revised human health risk assessment for chlorpyrifos, in late December 2014, the U.S. Environmental Protection Agency (EPA) filed a Response to the Petition for a Writ of Mandamus that the Pesticide Action Network North America and the Natural Resources Defense Council, among others, filed in September 2014 in the U.S. Court of Appeals for the Ninth Circuit. This action is the latest of several brought to try to achieve a ban of chlorpyrifos and a revocation of food tolerances for chlorpyrifos.

EPA’s December 2014 response states that its “thorough consideration of these issues will inform its ultimate decision whether to leave in place the tolerances for chlorpyrifos or cancel chlorpyrifos registrations, and a full record will facilitate any subsequent judicial review of those decisions.”

On January 7, 2015, EPA included in a status report to the court the issuance of its revised human health risk assessment. EPA indicated that currently it plans to “issue a proposed rule to revoke tolerances in early 2015 or a final denial order in mid-2015.”

It is not clear what EPA implies by stating that it could issue a proposed tolerance revocation in “early 2015” when the assessment of chlorpyrifos has only recently been released, availability announced in the Federal Register on January 14, 2015, and there is an open comment period on the document scheduled to close on March 16, 2015. Any action would presumably take some time, given the need to review submitted comments and formulate a response. Preparing any regulatory action would take some additional amount of time, especially since registrants of chlorpyrifos products can be expected to have substantial comments on the documents.
 


 

By Lisa M. Campbell, James V. Aidala, and Susan Hunter Youngren, Ph.D.

On January 5, 2015, the Natural Resources Defense Council (NRDC) filed a petition for review in the U.S. Court of Appeals for the Ninth Circuit challenging the November 6, 2014, decision of the U.S. Environmental Protection Agency (EPA) to allow the continued use of tetrachlovinphos (TCVP) in flea control products used on pets. NRDC’s 2009 petition sought to cancel all pet uses of TCVP based on alleged potential health risks to children.

Background

In February 2014, NRDC filed a petition for a writ of mandamus in the United States Court of Appeals for the District of Columbia Circuit seeking the court to compel EPA to respond to NRDC’s petitions to cancel all manufacturer registrations and uses of propoxur and TCVP, which are used in pet flea treatment products. Sergeant’s Pet Care Products, Inc., Wellmark International, and Hartz were among flea collar brands at issue.

In March 2014, EPA announced an agreement with Sergeant’s Pet Care Products, Inc. and Wellmark International, whereby the companies voluntarily cancelled the use of propoxur in flea collars. Related uses of other chemicals, including TCVP in pet collars, were not addressed in that agreement, and EPA denied, in November 2014, NRDC’s 2009 petition seeking to cancel all pet uses of TCVP.

NRDC first petitioned EPA to cancel propoxur uses in pet collars in 2007. NRDC filed a petition in April 2009 to cancel all pet uses of TCVP based on its Poison on Pets II report, which asserted that unsafe levels of pesticide residues are present on dogs and cats after a flea collar is used.

EPA conducted a risk assessment of multiple pet use products (e.g., shampoos, dips, powders, and flea collars) containing TCVP in 2006 during the reregistration process. The majority of the uses were assessed using registrant-submitted chemical-specific data. Potential post-application assessments for the majority of the uses included assessing dermal contact with the treated animal (e.g., a child hugging a dog) and hand-to-mouth contact by a toddler following contact with treated animals (e.g., touching the dog and then putting their hand in their mouth). These were considered to be worst-case assessments based on the amount of dermal and hand-to-mouth contact used by EPA. Potential post-application exposure to adults and children were not assessed for flea collars. In the case of flea collars, EPA concluded: “Post application exposure to residues from pet collars is considered to be insignificant when compared with exposure to other products. Because other, higher exposure uses were not of concern, an assessment for collars was not conducted.”

This last sentence is especially important, as EPA is likely to reiterate this conclusion, whether curtly or in detail, as its direct response to the petition. As this is a fairly predictable Agency response, NRDC appears to want this petition to signal its continuing concerns about organophosphate use generally, and be able to raise concerns about “children’s risks” in particular.
 

Tags: NRDC, petitions, TCVP,

 

By Lisa M. Campbell

On July 7, 2014, the Natural Resources Defense Council (NRDC) filed with the U.S. Environmental Protection Agency (EPA) a petition requesting that EPA commence a Special Review for the neonicotinoid pesticides, including six specific active ingredients (dinotefuran, acetamiprid, clothianidin, thiacloprid, imidacloprid, and thiamethoxam), based on the risk that NRDC believes this class of compounds poses to honey bees and native bees. In the petition, NRDC alleges that neonicotinoids “may suppress bee immunity, disrupt brood cycles, impair foraging behavior by interfering with memory and learning, and cause disorientation, preventing bees from finding their way back to the hive.” By submitting this petition, NRDC effectively asks that EPA expedite the evaluation of the effect of this class of active ingredients on pollinators that EPA already intends to undertake as part of the Registration Review process required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(g), 7 U.S.C. § 136a(g). A copy of the petition is available online.