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 and Heather F. Collins, M.S.

On Friday, November 3, 2017, the California Department of Pesticide Regulation (DPR) issued guidance (California Notice 2017-13) that DPR indicates is intended to align DPR policy with the U.S. Environmental Protection Agency’s (EPA) guidance on secondary container labeling for pesticides.  DPR’s guidance states that secondary containers are used by the pesticide industry as part of the process of applying pesticides and “cannot be sold or distributed.”  The guidance further notes that secondary containers are “most commonly used in institutional settings for concentrated antimicrobials that are diluted prior to use or to hold pesticides filled from a larger container to be used and stored prior to application.” 

Registrants may elect to provide users with labels for secondary containers.  DPR’s new guidance states:  “Secondary container labels are not required to be submitted to U.S. EPA or DPR.”  Under the new DPR policy, however, effective immediately, if a registrant submits a secondary container label to DPR, “it must bear the same signal word as the concentrate label or no signal word.”  DPR states that it will accept a secondary container label with a lesser signal word, precautionary statements, and alternate directions for use for the diluted product only if acute toxicity data are submitted or are currently on file to support these lesser statements.

DPR’s new guidance also incorporates EPA guidance on what a secondary label should contain.  (EPA does not require secondary containers to be labeled, but notes that the applicator remains responsible for following the requirements on the pesticide product’s labeling, and complying with other relevant requirements in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other statutes.)  Although registrants are not required to submit secondary container labels to EPA for review, EPA recommends that the applicator identify the material in the secondary container in the event of a spill to ensure that adequate information regarding the pesticide can be obtained in case of a medical or environmental emergency.  EPA recommends that such labels include the following information:

  • Product name;
  • EPA registration number;
  • Name and percentage of active ingredient of the concentrated product or if known, the percentage of active ingredient in the end-use dilution;
  • If the product in the secondary container is diluted, it should be followed by the phrase:  “The product in this container is diluted as directed on the pesticide product label”;
  • The same signal word as the registered concentrate container label;
  • The same precautionary statements as the registered concentrate container label unless the registrant has acute toxicity data supporting lesser precautionary statements for the diluted product and alternate directions for the diluted product are indicated on the concentrate container label; and
  • The statement:  “Follow the directions for use on the pesticide label when applying this product.”

DPR states:  “If currently registered products have secondary container labels on file with DPR that do not meet the above criteria, registrants should submit revised labels to DPR as an amendment.”

Each submission must include:

  • California Application to Amend Pesticide Product (DPR-REG-035);
  • $25 application fee (payable to:  Cashier, Department of Pesticide Regulation);
  • A copy of the most current EPA stamp-accepted label;
  • Six copies of the concentrate container label; and
  • Six copies of the secondary container label.
    • If the precautionary statement on the secondary container label bears lesser precautionary statements, the submission must be accompanied by acute toxicity data or a reference to data on file with DPR.

As an alternative to submitting revised labels, registrants have the option of requesting that DPR rescind acceptance of the current stamp-accepted secondary container label previously submitted.  Registrants may submit their request in writing on company letterhead to their assigned Regulatory Scientist.  If a secondary container label is inconsistent with the DPR-approved label, DPR will consider the product misbranded, and DPR notes that misbranded products are subject to enforcement action.

Registrants that have previously submitted secondary labels to DPR should review the label in comparison to the DPR-approved concentrate container label and the requirements in this notice.  All inconsistencies must be corrected via amendment submission to DPR or by making a request that DPR rescind acceptance of the current stamp-accepted secondary label so that the product is not considered misbranded and therefore subject to enforcement action.  


 

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.