By Lisa M. Campbell and Lisa R. Burchi

On September 29, 2021, the U.S. Environmental Protection Agency (EPA) announced developments in its efforts to address per- and polyfluoroalkyl substances (PFAS) in the environment. In particular, EPA provided an update on its progress in testing pesticide products and containers for PFAS.

EPA states that as part of its ongoing efforts, it is releasing an internally validated method for the detection of 28 PFAS compounds in oily matrices, such as pesticide products formulated in oil, petroleum distillates, or mineral oils. According to EPA, the oily matrix method is modified from EPA Method 537.1, a method that is mainly used for drinking water and was previously used in analyzing PFAS in fluorinated high-density polyethylene (HDPE) containers.

The new method is intended to assist pesticide manufacturers, state regulators, and other interested stakeholders in testing oily matrix products for PFAS and joining efforts to detect any possible contamination. In the announcement, EPA states: “In a shared interest to remove PFAS from the environment, if companies find PFAS in their product, EPA is requesting that they engage in good product stewardship and notify the Agency.”

In developing this method, EPA collaborated with the Maryland Department of Agriculture. As part of this collaboration, the method was used to analyze three stored samples of mosquito control pesticide products as well as samples obtained directly from the product line from the pesticide manufacturer. EPA determined that none of the tested samples contained PFAS at or above EPA’s method limit of detection.

EPA states that its investigation continues to determine the scope of this issue and its potential impact on human health and the environment. EPA acknowledges that “[t]o date, the only PFAS contamination in mosquito control pesticide products that the Agency has identified originated from fluorinated HDPE containers used to store and transport a different mosquito control pesticide product.” EPA will continue to test additional fluorinated containers to determine whether they contain and/or leach PFAS and will present those results when the studies are complete. EPA further states it is working with other federal agencies and trade organizations to raise awareness of this issue and discuss expectations of product stewardship. EPA also is encouraging the pesticide industry to explore alternative packaging options, such as steel drums or non-fluorinated HDPE.

Additional information on EPA’s oily matrix method report and information on PFAS in pesticide packaging is available here.

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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.  

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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.

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