Announcing the Closure of 2,000 Antimicrobial Notifications on June 29, 2023
EPA Plans to Finalize Certain Antimicrobial Notification Procedures to Reduce Pending Tasks and Enhance Operational Efficiency
In a move to declutter its workload, the Environmental Protection Agency (EPA) announced on June 29, 2023, it will be closing out approximately 2,000 minor antimicrobial pesticide label or product formulation changes submissions. This initiative aims to tackle the growing backlog, allowing the EPA to focus on more pressing actions.
The target actions were submitted to the Agency prior to October 1, 2022, and do not jeopardize the product's safety as per the approved label instructions or pose any threat to human health or the environment. This move applies only to non-Pesticide Registration Improvement Act (PRIA) notification actions.
The EPA's backlog of pesticide actions has been on the rise due to factors like a shrinking budget, reduced workforce, escalating workload, and the increasing complexity of actions submitted to the Agency. Since 2004, the total number of pesticide actions coming into the Agency annually has ranged between 10,000 to 20,000, reaching a peak in 2021 during the COVID-19 public health emergency.
As of now, the Antimicrobials Division at EPA is grappling with over 6,693 overdue non-PRIA pesticide actions, of which around 2,000 are being closed out. This step will save the Agency valuable time and resources to manage the remaining notification backlog, while ensuring consistent protection of human health and the environment.
Under Pesticide Registration (PR) Notice 98-10, manufacturers can sell and distribute antimicrobial products with labels that conform to the requested notification changes 60 days after submitting a notification to the EPA, provided they receive an approval or no response from the Agency. Some changes eligible for notifications under PR Notice 98-10 include:
- Brand name alterations
- Inclusion of specific indoor, non-food use sites
- Packaging and labeling statement modifications
- Storage and disposal statement updates (as per the Container Rule and PR Notices 83-3 and 84-1)
- Revisions to certain label claims and limited CSF updates
- Use of symbols and graphics
- Other minor label revisions
With the review period for these registrant-submitted changes having elapsed, manufacturers are now authorized to market their products without EPA approval. The EPA will not be issuing letters concerning the closed notifications or updating the affected labels on the Pesticide Product and Label System. However, should the EPA discover, in the future, that any changes were ineligible for notification under PR Notice 98-10, the Agency will alert the manufacturer for necessary label or CSF corrections.
The closure is effective as of June 28, 2023. Companies unsure about their outstanding label or CSF notifications can contact the Antimicrobials Division by emailing AD_BL_Actions@our website to obtain a complete list of notification actions for their specific product(s), including those closed out as part of this announcement. The EPA is collaborating with state co-regulator partners to ensure they are informed about these closed notifications. No further communication with EPA is necessary for companies whose notifications are affected.
[1] The EPA's closure of around 2,000 antimicrobial notifications in June 2023 confirms the approved status of these products’ labels and formulations, enabling their continued compliant use and marketing. For companies seeking to verify if they have any outstanding label or CSF notifications, the EPA offers resources through its online pesticide label databases or by contacting the EPA’s Office of Pesticide Programs for status updates or clarifications. This process provides regulatory certainty for antimicrobial product stakeholders and maintains effective oversight of antimicrobial pesticides in the market.
- The closure of around 2,000 antimicrobial notifications by the Environmental Protection Agency (EPA) in June 2023 confirms the approved status of these products' labels and formulations, facilitating their continued compliant use and marketability.
- In light of the EPA's closure of approximately 2,000 antimicrobial notifications, companies seeking to verify their outstanding label or CSF notifications can refer to the EPA's online pesticide label databases or reach out to the EPA's Office of Pesticide Programs for updates or clarifications, thereby ensuring regulatory compliance and effective oversight of antimicrobial products in the industry.
