Details

EPA is hosting a listening session via webinar to get input from stakeholders on the development of a risk-based product testing strategy to ensure continued effectiveness of hospital disinfectant products. The listening session will be on June 21, 2018, from 1-3 p.m. ET.

The target audience for this listening session includes:

• Pesticide product registrants
• Microbiology laboratory personnel with efficacy testing responsibilities

Register for the listening session. Exit

Purpose and Goals

EPA is holding this listening session in response to recommendations from the Office of the Inspector General (OIG) in Report Number 16-P-0316. The OIG recommended development of risk-based testing for registered public health pesticides that have entered the marketplace and are used in hospital settings.

The OIG report asked that EPA address at least the following five elements:

1. Define program scope;
2. Develop framework for periodic testing;
3. Identify risk factors and metrics for product selection;
4. Identify method to obtain samples for testing; and
5. Designate a date to commence risk-based post-registration testing.

EPA’s goals are (1) to develop and implement a risk-based approach to select hospital disinfectant products for efficacy testing that will ensure the continued effectiveness of products in the marketplace; and (2) to improve the efficiency of the process to sample and test these products.

Focus Questions

During the webinar, EPA will share some preliminary thoughts addressing the five elements listed above and discuss the following focus questions:

• Are there additional considerations we should include within the scope?
• How can we integrate emerging pathogens?
• Are the risk factors under consideration suitable for prioritizing product selection?
• What additional attributes should be considered?
• Which risk factors should we consider critical in setting testing priorities?
• What should be the role of registrants in conducting sample collection and testing?
• What options should be considered for sample collection?
• What options are necessary to ensure samples are readily available?
• What would be an appropriate frequency for testing and what would be the rationale (e.g., cyclical, random, event based collections)?
  • Could random testing meet the risk-based criteria? How?
  • What factors should we consider in determining testing frequency?
• Are there factors that would eliminate a product or group of products from the post-market testing requirements (e.g., DCIs etc.)?

Submitting Your Comments

After the listening session, stakeholders will have an opportunity to submit comments to docket EPA-HQ-OPP-2018-0265 at www.regulations.gov.

EPA will consider listening session feedback and written comments submitted to the docket when developing a draft strategy for the revised Antimicrobial Product Evaluation Program.