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, Heather F. Collins, M.S., and Barbara A. Christianson

On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced a new policy that will allow registrants of antimicrobial pesticide products voluntarily to disclose all inert ingredients more efficiently in response to the request of retailers, states, and industry.

Registrants who wish to disclose all inert ingredient can choose to do so in three ways under the new policy:

  • On the product label as part of the full ingredient statement or on the product’s back or side panel with a referral to the full ingredient statement;
  • On a website referenced on the product label; or
  • On a website that is not directly linked to the product label.

EPA states that it will allow registrants to use alternate nomenclature to disclose inert ingredients.  This policy is effective as of January 16, 2021

EPA states that there is no statutory or regulatory requirement to identify inert ingredients in the ingredient statement, except when EPA determines that such inert ingredients may pose a hazard to humans or the environment.  EPA states that if EPA determines an inert ingredient may pose a hazard, EPA may determine that the name of the inert ingredient must be listed in the ingredient statement on a case-by-case basis for either risk-based or hazard-based reasons.  Examples include the following ingredients:

  • Petroleum distillates, xylene, or xylene range aromatic solvents > 10%;
  • Sodium nitrate > 0.1%; or
  • Inert ingredients of toxicological concern (formerly known as “List 1 Inerts”).

EPA’s long-standing policy, as stated in its Label Review Manual, has been that “if a registrant wants to list a particular inert ingredient in the ingredient statement, the registrant should list all inert ingredients directly below the ingredient statement in descending order by weight. A partial listing on the label could be misleading.”  EPA’s new policy applies to voluntary identification of inert ingredients using alternate nomenclature and not to cases where EPA directs registrants to list particular inert ingredients because of risk-based or hazard-based reasons.

EPA states that beginning December 15, 2020, the Office of Pesticide Programs (OPP) will review antimicrobial pesticide applications for voluntary inert ingredient disclosure.  Under this new process, EPA states that if a registrant chooses to utilize alternate chemical nomenclature on its product labeling, the registrant must resubmit the Confidential Statement of Formula (CSF) containing the inert ingredient as approved on the existing formulation as well as the alternate chemical nomenclature.  EPA requires that a “crosswalk” between the approved nomenclature of the CSF and the alternate nomenclature be provided with the registrants’ non-Pesticide Registration Improvement Extension Act (PRIA 4) application, which will fall under a 90-day review.

If registrants choose to use alternate nomenclature, EPA encourages using the following sources:

If a registrant chooses to disclose voluntarily inert ingredients on the label, the registrant should list all of the inert ingredients directly below the ingredient statement in descending order by weight, so that the list does not interfere with the required labeling information.  If space is limited, however, to avoid crowding of required labeling information, a referral statement may be used directing the reader to the back or side panel for the full list of inert ingredients in descending order by weight.  The referral statement should be placed directly below the ingredient statement with an asterisk or some other equivalent symbol connecting the “Inert Ingredients” or “Other Ingredients” heading in the ingredient statement with the full list of inert ingredients placed on the back or side panel of the label.  For example, an acceptable referral statement is “*See back panel for complete inert ingredient statement,” and acceptable corresponding text on the back panel is “*Inert Ingredients:  Inert A, Inert B., etc.”

When registrants choose to add a website address or quick response (QR) code to their labeling that leads to inert ingredient information, EPA asks that registrants, in a cover letter transmitting the labeling amendment application, self-certify that the inert ingredient information provided on the registrant’s website(s) and in other marketing materials is consistent with the information provided on the latest approved CSF.

EPA states that registrants do not need to amend its their master label or notify EPA before adding an inert ingredient statement to a website, provided that the site is not referenced on the product label.  In such cases, the application process outlined below does not apply.

EPA states that no other actions should be included with inert ingredient disclosure applications.  The following information is required to be included in the application:

  • Applications to add alternate nomenclature to the label must:
    • Crosswalk link the current CSF nomenclature to any alternate nomenclature as confirmation that the current CSF nomenclature and alternate nomenclature are synonyms of each other (the exact same inert ingredient).  EPA provides a template spreadsheet for the alternate nomenclature crosswalk to link the current CSF nomenclature to any alternate inert ingredient nomenclature.
    • Identify in the cover letter the proposed changes to the alternate nomenclature on product labels and CSFs, the revised CSF (which includes the current and alternate nomenclature) and master label with changes highlighted.
    • For applications to add currently approved nomenclature to the label registrants should include with the application a cover letter identifying the proposed change(s) on product labels and master label with changes highlighted, including the following self-certification statement: “The inert ingredients voluntarily disclosed in the labeling for EPA Registration No. [add registration number], are accurate for the EPA-registered product listed above. No changes to the product formulation have been made. I certify that no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. 1001 to willfully make any false statement to EPA. I further understand that if the information I have provided is misbranded as defined in section 2(q) of FIFRA, 7 U.S.C. 136(q), this product may be in violation of FIFRA and EPA may pursue enforcement actions under sections 12 and 14 of FIFRA, 7 U.S.C. 136(j) and 136(l).”
  • For applications to add or change a website or QR code to include inert information, applicants must include a cover letter that identifies the proposed change(s) on product labels and master label with changes highlighted, including the following self-certification statement: “The inert ingredients voluntarily disclosed in the labeling for EPA Registration No. [add registration number], are accurate for the EPA-registered product listed above. No changes to the product formulation have been made. I certify that no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. 1001 to willfully make any false statement to EPA. I further understand that if the information I have provided is misbranded as defined in section 2(q) of FIFRA, 7 U.S.C. 136(q), this product may be in violation of FIFRA and EPA may pursue enforcement actions under sections 12 and 14 of FIFRA, 7 U.S.C. 136(j) and 136(l).”

According to EPA, the scope of this policy is currently limited to antimicrobial pesticide products.  EPA states that it may consider expanding to conventional pesticide and biopesticide products in the future.

Additional information is available here.


 

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

The U.S. Environmental Protection Agency (EPA) has announced its new more “user-friendly” website for minimum risk pesticides. Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b)(2) and EPA’s implementing regulations at 40 C.F.R. § 152.25(f), pesticides meeting certain criteria (e.g., containing only specified, listed active and inert ingredients, not bearing public health claims) are determined by EPA to pose little to no risk to human health or the environment and exempt from FIFRA registration requirements. EPA states the website “highlights the most-requested information and has been redesigned based on historic website traffic, with a focus on stakeholders who are interested in manufacturing, selling or distributing minimum risk pesticides.” Specifically, the website is now focused on four main areas:

          *   About Minimum Risk Pesticides;
          *  Conditions to Qualify as a Minimum Risk Pesticide Product;
          *  Clarifications about Minimum Risk Active and Inert Ingredients; and
          *  Regulation and Enforcement of Minimum Risk Pesticides.

Although the scope of application of minimum risk pesticides has been the focus of proposed regulatory changes in recent years, EPA states that this website is not intended to include any regulatory changes or new requirements. There is, however, a December 2010 rule proposing changes to the minimum risk pesticide requirements that has yet to be issued in final. It is noteworthy that EPA has highlighted and clarified its Section 25(b) policies, but has not yet issued a final rule. A memorandum regarding EPA’s proposed rule is available at http://www.lawbc.com/regulatory-developments/entry/epa-proposes-revisions-to-minimum-risk-exemption-for-pesticides/.

Instead, EPA states it has included more information to be clearer about the conditions that a product must meet to be considered minimum risk. Any clarifications of the applicable requirements could be helpful for manufacturers that are responsible for ensuring compliance at the federal level for minimum risk pesticides since EPA does not review or approve such registrations. It is important to note that minimum risk pesticides exempt from EPA registration are still frequently subject to registration requirements at the state level, and state regulators perennially identify non-compliance by products asserting eligibility for minimum risk status. Any outreach that makes the eligibility and compliance requirements clearer should assist companies in navigating both federal and state requirements.

The address for the new website is www2.epa.gov/minimum-risk-pesticides.


 


 

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.


 

By Lynn L. Bergeson

On October 22, 2014, the U.S. Environmental Protection Agency (EPA) requested public comment on a proposal to remove 72 chemicals from its list of substances approved for use as inert ingredients in pesticide products. EPA reportedly is responding to petitions submitted by the Center for Environmental Health, Beyond Pesticides, Physicians for Social Responsibility, and others that have asked EPA to issue a rule requiring disclosure of 371 inert ingredients found in pesticide products. EPA developed an alternative strategy designed to reduce the risks posed by hazardous inert ingredients in pesticide products more effectively than by disclosure rulemaking. EPA outlined its strategy in a May 22, 2014, letter to the petitioners, which is available online. Many of the 72 inert ingredients targeted for removal are on the list of 371 inert ingredients identified by the petitioners as hazardous. The 72 chemicals are not currently being used as inert ingredients in any pesticide product.  The list of chemicals is available online.

Ingredients that are directly responsible for controlling pests such as insects or weeds are called active ingredients. An inert ingredient is any substance that is intentionally included in a pesticide that is not an active ingredient. Comments are due November 21, 2014. General information on inert ingredients can be found online.