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 Lynn L. Bergeson, Lisa M. Campbell, and Lisa R. Burchi

On June 29, 2016, the U.S. District Court for the Northern District of California (Court) issued an opinion dismissing the complaint and denying the motion for summary judgment of the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (CEH, et al.), and granting the U.S. Environmental Protection Agency’s (EPA) motion for summary judgment. 

Background

This case stems from a petition filed in 2006 requesting EPA to initiate a rulemaking to require the labeling of 371 inert ingredients in pesticides.  EPA issued an Advance Notice of Proposed Rulemaking (ANPR) in 2009, but did not proceed further with a rulemaking.  CEH, et al. filed a second lawsuit in March 2014, alleging that EPA’s failure to complete the rulemaking process started by the ANPR violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Administrative Procedure Act (APA).  In May 2014, EPA responded by amending its response to the 2006 petition to explain that it had decided to pursue an approach different from requiring mandatory disclosure on the pesticide label of a hazardous inert ingredient.  EPA announced that it would instead pursue a “‘combination of regulatory and focused non-regulatory actions that do not rely on rulemaking’ including potentially:  (1) removing over ninety chemicals from the list of inert ingredients approved for pesticide use; (2) evaluating the effect of the 371 inert ingredients on food crops; (3) directing pesticide registrants to modify their registrations by replacing hazardous inert ingredients with less hazardous ones; and (4) seeking to expand the existing voluntary disclosure program.”  The Court granted EPA’s motion for judgment on the pleadings in the March 2014 lawsuit, “finding that there was no further relief that [the Court] could offer to plaintiffs and that the action was moot.”

CEH, et al.’s complaint in the case at issue challenges EPA’s May 2014 denial of its rulemaking petition, alleging that under FIFRA and APA, EPA’s decision to deny the rulemaking petition was “arbitrary, capricious, and contrary to [FIFRA].”  CEH, et al. requested the court to “set aside the denial and to remand the decision to the EPA to consider ‘the evidence weighing in favor of disclosure of inert pesticide ingredients.’”  Background on the complaint is available in our blog item NGOs File Suit Regarding Inert Ingredients’ Disclosure.

In support of its ruling to grant EPA’s motion for summary judgment, the court stated:  “EPA is not mandated to require disclosure of the inert ingredients at issue,” since “[p]laintiffs have provided no persuasive evidence that EPA’s decision to forego rulemaking is inconsistent with the ANPR.”  The Court noted, for example, that EPA’s regulation governing disclosure of inert ingredients, 40 C.F.R. § 156.10(g)(7), states that “[t]he Administrator may require the name of any inert ingredient(s) to be listed in the ingredient statement if he determines that such ingredient(s) may pose a hazard to man or the environment”; this allows EPA to require applicants to list hazardous inert ingredients, but “does not mandate it.”  In addition, the Court found that EPA’s decision “that a series of non-rule actions would achieve a greater reduction in the risks from the use of pesticides and could be implemented in a timelier manner,” was not arbitrary or capricious, even if it “conceivably offers a less effective remedy than what plaintiffs sought.”

Discussion

The decision supports EPA’s discretionary authority to determine how to best manage and address any inert ingredients that may cause unreasonable adverse effects on the environment.  EPA has set forth several actions that it is taking or intends to take in lieu of mandatory label disclosure of inert ingredients.  For example, on October 22, 2014, EPA proposed to remove 72 chemical substances from the current listing of inert ingredients approved for use in pesticide products because the inert ingredients are no longer used in any registered pesticide product.  Registrants of any pesticides containing a potentially hazardous inert ingredient should monitor how EPA’s regulatory and focused non-regulatory actions affect such substances.  


 

By Lisa M. Campbell and Lisa R. Burchi

On November 6, 2015, the U.S. Environmental Protection Agency (EPA) announced that it has a new webpage that compiles information about secondary containers and service containers for pesticides.  Secondary and service containers are containers that are used by the pesticide industry as part of the process of applying pesticides, not for further sale or distribution.  EPA states that the website combines and replaces information previously found on the Labeling Questions and Answers page and in the Label Review Manual, and addresses frequently asked questions.  The announcement states “this is not new guidance, but the EPA hopes this new resource will make information on secondary and service containers easier to find and will lead to improved handling of these containers.”  According to EPA, the webpage is designed to help pesticide registrants and applicators:

  • Understand EPA’s definition of secondary and service containers;
  • Learn about EPA’s recommendations for good management practices when labeling secondary and service containers; and
  • Learn how to properly identify the contents of a secondary or service container, including when the pesticide is diluted.

Although registrants are not required to submit labels to secondary containers to EPA for review, EPA provides the following Q&A for when EPA will approve such labels if submitted to EPA for review:

      Q:  If a registrant wishes to submit and have EPA review the secondary container label, what does EPA require?

      A:  As it isn't required that a secondary container label be submitted, there are no requirements per se.  EPA will review them on a case-by-case basis and would be likely to accept them if:

  • The EPA-approved master label includes directions for diluting the product.
  • The secondary container label is submitted as part of the master label.
  • The master label bears a statement that the secondary container must be labeled as presented on the master label (e.g., “When this product is diluted in accordance with the directions on this label, the dilution container must bear the following statements:”)
  • The secondary container contains a statement prohibiting further sale or distribution.
  • The secondary container may have reduced precautionary language (if supported by dilution-specific acute toxicity data), but not a reduced signal word.

Requirements governing secondary containers are often a source of questions within the regulated community; many may find EPA’s new website a useful source of information on this topic.


 

By Lisa M. Campbell

On December 19, 2014, the U.S. Environmental Protection Agency (EPA) announced it is preparing in final the regulations on pesticide export labeling. The new proposed rule corrects the inadvertent removal of a provision that occurred in the January 2013 revisions to these regulations. EPA is restoring the provision that allows information required under the regulations to be placed on collateral labeling (such as bulletins, leaflets, circulars, brochures, data sheets, or flyers) attached to a shipping container of pesticide products rather than on the immediate package of each individual product in the shipment.

Producers of pesticide products and devices intended solely for export will meet EPA’s labeling requirements by attaching a label to the immediate product container, or by providing collateral labeling that is either attached to the immediate product being exported or that accompanies the shipping container of the product being exported at all times when it is shipped or held for shipment in the United States. Collateral labeling will ensure the availability of the required labeling information, while allowing pesticide products and devices that are intended solely for export to be labeled for use in and consistent with the applicable requirements of the importing country.

On January 18, 2013, EPA revised its export label regulations (40 C.F.R. Part 168 Subpart D) concerning the labeling of pesticide products and devices intended solely for export. The revisions were effective on March 19, 2013, with a compliance date of January 21, 2014. Industry stakeholders subsequently expressed concern to EPA that certain provisions no longer appeared in this Subpart, and the inability of registrants to use the labeling method allowed in the previous regulations could create trade barriers and increase costs. EPA agreed and on April 30, 2014, issued a direct final rule to replace the provision that was inadvertently removed. Since EPA received written adverse comment on the direct final rule, EPA withdrew that direct final rule, and issued a new proposed rule to seek public comment on the changes. EPA is now preparing the revisions in final to its export labeling regulations to replace the provision that was inadvertently removed.

The final revisions are available at www.regulations.gov, docket number EPA-HQ-OPP-2009-0607. Additional information on EPA requirements for importers and exporters is available at www2.epa.gov/importing-exporting.
 


 
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