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

On September 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is terminating the Temporary Amendment to Pesticide Registration (PR) Notice 98-10, effective September 15, 2022. EPA states that it is providing 12 months’ notice to registrants before the termination takes effect to give registrants time to adjust their contractual commitments. Registrants must ensure that by September 15, 2022, their product is produced using a source of active ingredient identified in the product’s EPA-approved Confidential Statement of Formula (CSF) or otherwise complies with the requirements of PR Notice 98-10. All notifications submitted to EPA under the temporary process are valid only for the time period of the temporary amendment. After September 15, 2022, registrants “will not be able to release for shipment formulations produced under the conditions of the temporary amendment without first complying with the registration requirements that were in place prior to the issuance of the temporary amendments.”

EPA states that this notice applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (the virus that causes COVID-19) or products that serve as the source of active ingredient for disinfectants on EPA’s List N. This notice also applies to food contact surface sanitizer products containing the active ingredient isopropyl alcohol that are used in the essential role of food manufacturer and preparation.

In 2020, EPA issued temporary amendments to PR Notice 98-10 to ensure that antimicrobial products remained available in response to the COVID-19 public health emergency. According to EPA, supply chains have stabilized and disinfectant products expected to kill SARS-CoV-2 have become consistently available to consumers, so it has determined that this flexibility is no longer needed. When the temporary amendment was issued, EPA stated it would assess the continued need for and scope of the temporary amendment to PR Notice 98-10 on a regular basis and would update it if EPA determined modifications were necessary. EPA stated it would post a notification at www.epa.gov/pesticides at least seven days prior to terminating the temporary amendment. EPA acknowledges in the termination memorandum that registrants require time to make the temporary changes permanent through CSF amendment or notification and therefore is providing 12 months, rather than the seven days guaranteed in the temporary amendment.

The memorandum addressing the termination is available here. Information on the temporary amendments to PR Notice 98-10 are available on our blog.


 

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

On May 10, 2021, the U.S. Environmental Protection Agency (EPA) announced the launch of an electronic Confidential Statement of Formula application (eCSF builder) to support pesticide registration applications. The new electronic tool is part of EPA’s interest in improving and modernizing the internal processes and digital workflows for pesticide registration submissions.

As part of the registration process for new pesticide products, EPA requires the submission of a Confidential Statement of Formula (CSF). The form lists all the product’s components and percent by weight, along with various additional information.

Currently, CSF applications must be submitted to EPA in hard copy. The new eCSF builder will automatically validate certain data in a CSF application prior to submission to EPA. EPA states this functionality, along with real-time validation of chemical ingredients through EPA’s Substance Registry Services, will make the pesticide registration process more efficient, saving EPA and registrants time and resources. While paper CSF forms remain available, EPA encourages submitting applications electronically, as the review of paper applications could be a longer process.

Users can access the eCSF builder on the Central Data Exchange (CDX) under Pre-Submission Tools, Form Builders, by clicking the Create eCSF button. Users can provide feedback to EPA through the CDX.

Additional information is available on our blog.


 

By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson

On May 12, 2020, the U.S. Environmental Protection Agency (EPA) announced additional procedures for registrants to add new disinfectant products to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 that are considered to be safe and effective for use against SARS-CoV-2, the virus that causes COVID-19.

EPA states that it intends to expedite reviews of certain Pesticide Registration Improvement Extension Act (PRIA 4) submissions for products intended for use against the SARS-CoV-2.  These actions include requests to amend currently registered products that require a review of efficacy data and applications for new pesticide product registrations that would qualify for List N for use against SARS-CoV-2.  This process does not replace the review process of all other submitted antimicrobial products.

EPA states that it also may consider expedited review of new active ingredients (AI) or new uses for currently registered AIs (including higher application rates, new application methods such as fogging and electrostatic sprayers, or use sites such as porous surfaces).

The following submissions may qualify for expedited review:

Amendments for Currently Registered Products

  • A request to add a virucidal claim to a product that requires EPA to review efficacy data (including both newly submitted data and citations to existing data);
  • A request to add a new unregistered source of a non-commodity active ingredient (active ingredient not listed in the May 11, 2020, Temporary Amendment to PR Notice 98-10) to a product’s Confidential Statement of Formula; and
  • A request that involves changes to a product’s formulation that requires EPA to review confirmatory efficacy data. Confirmatory efficacy data are a reduced set of data used to support certain changes in formulation to a registered product.

New Products – formulated with currently registered AIs that are contained in disinfectant and/or sanitizer pesticide products approved for use in residential, commercial, institutional, and industrial settings.

  • A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with a registered source of active ingredient(s); and
  • A submission of an application for a new pesticide product that requires EPA to review newly submitted efficacy data to support virucidal claims where the product is formulated with an unregistered source of the active ingredient(s).

Additional information on EPA’s requirements and process for submissions to be considered for expedited review is available here

EPA also announced the availability of its new List N Tool: COVID -19 Disinfectants, a new web-based application (app) that allows smart phone users and others to access List N to identify disinfectant products that meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19. 

For several months, EPA has provided the public with List N, which currently lists 410 surface disinfectant products that meet EPA’s criteria for use against SARS-CoV-2.  EPA is now making available the data from the List N webpage on a browser-based web app that allows users to identify the disinfectant products best suited for their needs.  Users can search by use site (e.g., home, business, health care, etc.), surface type (e.g., hard, non-porous surfaces like countertops; porous surfaces like fabrics), contact time (i.e., the time the product needs to be visibly wet), EPA registration number, AI(s), or product name.


 

By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson

On April 14, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing registrants to notify EPA of certain formulation and manufacturing facility changes and immediately release the product for sale without waiting for EPA approval.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N). 

EPA’s announcement builds on EPA’s temporary amendment to Pesticide Registration (PR) Notice 98-10 announced on March 31, 2020.  Among other changes, the temporary amendment to PR Notice 98-10 streamlines the process for adding additional registered sources of active ingredients to a formulation and setting up an approved pesticide manufacturing establishment.  This enhanced flexibility allows List N with registered sources of active ingredients to be manufactured in those establishments without prior EPA approval. 

EPA’s temporary amendment to PR Notice 98-10 states that registrants may submit a notification to substitute registered sources of active ingredients that are not similar.  If registrants are unable to substitute a similar registered source (similar defined as the active or inert ingredient obtained from the source has the same Chemical Abstracts Service Registry Number (CASRN) and same purity) of the active ingredient, they may use an alternate source but must adjust the inert ingredient to ensure the nominal concentration of the active ingredient in the product does not change.  As long as the nominal concentration of the active ingredient in the product remains the same and adjustments in inert ingredients is limited to water only, this change will be allowed by notification and confirmatory efficacy data will not be required.

Additionally, EPA’s temporary amendment to PR Notice 98-10 will allow registrants to submit a notification to add EPA-registered establishments for formulations having a registered source of the active ingredient and where there are no other changes to the formulation.

EPA states that the changes allowed through notification by this action will not result in any substantive changes to the final pesticide formulations already approved by EPA, and the products’ effectiveness will not be affected and the products’ current precautionary labeling will remain protective.  EPA adds this action will not cause any unreasonable adverse effects to human health and the environment.

EPA states in its temporary amendment to Pesticide Registration (PR) Notice 98-10, the following procedures to submit a notification for currently registered disinfectant products listed on EPA’s List N:

  • A cover letter with a subject line that clearly indicates that this is a “notification per TEMPORARY AMENDMENT TO PR NOTICE 98-10 (April 14, 2020) for EPA Registration No. XXXXXX and [insert product name]”;
  • The active ingredient; and
  • The following certification statement:

[Name of Registrant] is submitting this notification consistent with the provisions of PR Notice 98-10 and [insert section(s) of the Temporary Amendment to PR Notice 98-10 dated April 10, 2020, and no other changes have been made to the Confidential Statement of Formula or labeling of this product.  I confirm that the ingredients statement of this label remains truthful.  I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA.  I further understand that if this self-certification is not consistent with the terms of PR Notice 98-10, the Temporary Amendment 98-10 dated April 10, 2020, and 40 C.F.R. 152.46, this product may be in violation of FIFRA and I may be subject to enforcement actions and penalties under section 12 and 14 of FIFRA.

Applications must be submitted via the CDX portal.  At this time, EPA is not accepting paper applications.  Once an application is submitted, EPA requests that an email is sent to the Product Manager for the product with the CDX tracking number (CDX _ 2020 _ XXXXXXX).  A registrant may distribute or sell a product modified according to this temporary amendment to PR Notice 98-10 once EPA receives the notification.  Receipt to EPA occurs when the requestor receives a CDX number when submitting the application via the CDX portal.

Additional information on submission information for registrants is available at Temporary Amendment to PR Notice 98-10 and on our blog.


 

By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson

On March 31, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing manufacturers of certain already-registered EPA disinfectant products to obtain certain active ingredients from any source without prior approval from EPA.  This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N).  EPA announced on March 26, 2020, similar action on certain inert ingredients

EPA typically requires disinfectant manufacturers to first apply for and receive EPA approval prior to making a change in the source of the active ingredient.  Under this temporary amendment, however, manufacturers can source certain active ingredients from alternate suppliers by informing EPA.  Once EPA has been notified, the registrant can immediately distribute or sell a product modified according to this temporary amendment, provided that the resulting formulation is chemically similar to the current formulation (i.e., the purity of resulting product from the alternate source falls within the certified limits of the currently registered formulation for which they are making the source change).  EPA states that by allowing manufacturers to obtain certain active ingredients from any source it will help alleviate reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on List N.

The eligible active ingredients are:

  • Citric Acid, Chemical Abstracts Service Registry Number (CASRN) 77-92-9;
  • Ethanol, CASRN 64-17-5;
  • Glycolic Acid, CASRN 79-14-1;
  • Hydrochloric Acid, CASRN 7647-01-0;
  • Hypochlorous Acid, CASRN 7790-92-3;
  • Hydrogen Peroxide, CASRN 7722-84-1;
  • L-Lactic Acid, CASRN 79-33-4; and
  • Sodium Hypochlorite, CASRN 7681-52-9.

EPA will assess the continued need for and scope of this temporary amendment on a regular basis and will update it if EPA determines modifications are necessary.  EPA will notify the public at least seven days prior to terminating this temporary amendment at www.epa.gov/pesticides.

After the termination date of the temporary amendment, registrants will not be able to release for shipment new registered product unless that product is produced using a source of active ingredient identified in the product’s approved Confidential Statement of Formula (CSF) or otherwise would have complied with relevant requirements in the absence of this temporary amendment.

EPA states in its temporary amendment to Pesticide Registration (PR) Notice 98-10, the following procedures to submit a notification for currently registered disinfectant products listed on EPA’s List N:

  • A cover letter with a subject line that clearly indicates that this is a “notification per TEMPORARY AMENDMENT TO PR NOTICE 98-10 (Insert date or other citation) for EPA Registration No. XXXXXX and [insert product name]”;
  • The active ingredient; and
  • The following statement:

[Name of Registrant] is notifying EPA of its intent to use one or more alternate, unregistered sources of active ingredient listed in the TEMPORARY AMENDMENT TO PESTICIDE REGISTRATION (PR) NOTICE 98-10 (Insert date or other citation) in the formulation of EPA Registration No. [xxx-xx].  Each source is chemically identical to (i.e., within the certified limits of) the active ingredients in the Confidential Statements of Formula previously accepted by EPA [insert CSF date(s)]. This self-certification is consistent with the provisions of PR Notice 98-10 and no other changes have been made to the Confidential Statement of Formula or labeling of this product.  Further, I confirm that the ingredients statement of this label remains truthful.  I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA.  I further understand that if this self-certification is not consistent with the terms of PR Notice 98-10 and 40 C.F.R. 152.46, this product may be in violation of FIFRA and I may be subject to enforcement actions and penalties under section 12 and 14 of FIFRA.

Applications must be submitted via the CDX portal.  At this time, EPA is not accepting paper applications.  Once an application is submitted, EPA requests that an email is sent to .(JavaScript must be enabled to view this email address) with the CDX tracking number (CDX _ 2020 _ XXXXXXX).  A registrant may distribute or sell a product modified according to this temporary amendment to PR Notice 98-10 once EPA receives the notification.

Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.


 

By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson

On March 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is allowing flexibility to manufacturers of disinfectants and other pesticides to increase the availability of products for use against SARS-CoV-2, the coronavirus that causes COVID-19.  EPA announced that it is allowing manufacturers to obtain certain inert ingredients from different suppliers without EPA approval after manufacturers voiced concern with EPA about challenges they face obtaining inert ingredients with the disruption of the supply chain. 

EPA stated it is allowing applicants submitting registrations or registration amendments to obtain commodity inert ingredients, approximately 280 total as of today, from various sources without having to provide the supplier name and address on its Confidential Statement of Formula (CSF).  EPA, however, notes that only ingredients designated as commodity inert ingredients on its list will be eligible for this reduced CSF reporting.

EPA also announced it is continuing to expedite review of submissions from applicants requesting to add emerging viral pathogen claims to existing registered disinfectant labels.  Claims currently are being approved within 14 days, as resources allow, compared to the typical 90-day review.  EPA has added 70 new surface disinfectants to its List N: Disinfectants for Use Against SARS-CoV-2, which brings the total number of products listed to 351.

Additional information on EPA’s list of commodity inert ingredients is available here

Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and on our blog.


 

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

On May 2, 2018, during the U.S. Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, EPA announced the progress of its electronic pesticide label data submission project, SmartLabel, and its electronic Confidential Statement of Formula (eCSF) submission project.  The SmartLabel and eCSF will be submitted through EPA’s Pesticide Submission Portal (PSP) on the Central Data Exchange (CDX).

EPA is developing the SmartLabel program to improve efficiencies in the submission, review, and approval of pesticide label information.  EPA believes creation of electronic master labels as structured data will improve the accuracy and clarity of pesticide label information and will allow it to be revised easily and efficiently. 

EPA indicated that the SmartLabel program will use CDX for the creation of labels in XML format.  Once uploaded through CDX’s PSP, the label will undergo an internal validation and move through an internal workflow.  EPA anticipates this will aid in faster approvals of labels.

The eCSF is an electronic version of EPA’s current paper CSF (EPA Form 8570-4).  This eCSF submission option will allow applicants to electronically submit product specification data and will:

  • Pre-populate information such as product properties and manufacturing/formulating site addresses from the PSP log in;
  • Link the eCSF to previous electronically submitted product information; and
  • Link chemical names to EPA information sources.

The electronic form is anticipated to result in significant time savings for the applicant and the EPA reviewer.  EPA stated that most submitted CSF actions are modifications to current formulations and not all fields will need to be re-entered when submitting a modification using eCSF.  Additional benefits that EPA believes will result are a reduction in time and effort needed for error corrections, electronic data validation, and less reliance on paper-based processes.

The SmartLabel and eCSF teams are continuing to work with Office of Pesticide Programs (OPP) Divisions to harmonize OPP-wide vocabularies and data validation rules.  The SmartLabel team and eCSF team are also working to harmonize overlapping vocabulary.  Nine registrants are conducting testing on software development and most likely will participate in additional testing of the software.   

EPA anticipates that the SmartLabel and eCSF programs will move EPA from a paper-based workplace to a paperless workplace.  The SmartLabel and eCSF builders are anticipated to be released for voluntary submissions in Summer 2018, and EPA encourages registrants to submit labels and CSFs using the new builders.

EPA stated that any questions or comments on SmartLabel should be sent to Patricia Parrott at .(JavaScript must be enabled to view this email address) and questions or comments on eCSF should be sent to Diane Isbell at .(JavaScript must be enabled to view this email address) or Jimmy Davis at .(JavaScript must be enabled to view this email address).  Registrants should monitor these initiatives closely, as they may result in significant changes to their own internal processes relating to registration submissions and recordkeeping.