Document ID: EPA-HQ-OPP-2018-0265-0008
Agency: epa
Document Type: Notice
Title: Antimicrobial Performance Evaluation Program: Draft Risk-Based Strategy to Ensure the Effectiveness of Hospital-Level Disinfectants
Posted Date: 2019-10-02T04:00Z

[Federal Register Volume 84, Number 191 (Wednesday, October 2, 2019)]
[Notices]
[Pages 52502-52504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21401]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0265; FRL-10000-29]

Antimicrobial Performance Evaluation Program (APEP): Draft Risk-
Based Strategy To Ensure the Effectiveness of Hospital-Level 
Disinfectants; Notice of Availability and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of and soliciting public 
comment on the draft document, ``Antimicrobial Performance Evaluation 
Program (APEP): A (Draft) Risk-Based Strategy to Ensure the 
Effectiveness of Hospital-Level Disinfectants'' (hereafter referred to 
as the draft Strategy). This draft Strategy was developed by the EPA 
Office of Chemical Safety and Pollution Prevention (OCSPP) in response 
to the EPA Office of Inspector General (OIG) report titled: ``EPA Needs 
a Risk-Based Strategy to Assured Continued Effectiveness of Hospital-
Level Disinfectants.'' The draft Strategy provides a framework to 
ensure that registered hospital-level disinfectants and tuberculocide 
products continue to meet Agency efficacy standards once they are in 
the marketplace.

DATES: Comments must be received on or before December 2, 2019.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2018-0265, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:  For general information contact: 
Kristen Willis, Antimicrobials Division (7510P), Office of Pesticide 
Programs,

[[Page 52503]]

Environmental Protection Agency, Antimicrobials Division, 2777 S 
Crystal Drive, Arlington, VA 22202; telephone number: (703) 347-0515; 
email address: willis.kristen@epa.gov.
    For technical information contact: Tajah Blackburn, Antimicrobials 
Division (7510P), Office of Pesticide Programs, Environmental 
Protection Agency, Antimicrobials Division, 2777 S Crystal Drive, 
Arlington, VA 22202; telephone number: (703) 347-0260; email address: 
blackburn.tajah@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Introduction

A. Does this action apply to me?

    This action is directed to the general public. This action may be 
of interest to health care/hospital professionals and all entities who 
have EPA registered antimicrobial products that are available in the 
marketplace, particularly those with products that make hospital 
disinfectant claims (e.g., claims against Staphylococcus aureus and 
Pseudomonas aeruginosa) and other claims for notable public health 
pests (e.g., Clostridium difficile, methicillin resistant 
Staphylococcus aureus, Mycobacterium spp.). The Agency has not 
attempted to describe all specific entities that may be affected by 
this action. For questions regarding the applicability of this action, 
please consult the technical contact listed under FOR FURTHER 
INFORMATION CONTACT section of this notice.

B. What is EPA's authority for taking this action?

    This action is issued under the Federal Insecticide, Fungicide and 
Rodenticide Act, 7 U.S.C. 136 et seq. and the Federal Food, Drug, and 
Cosmetic Act, 21 U.S.C. 346a.

C. What action is the Agency taking?

    EPA is announcing the availability of and opportunity for public 
comment on the document, titled ``Antimicrobial Performance Evaluation 
Program (APEP): A (Draft) Risk-Based Strategy to Ensure the 
Effectiveness of Hospital-Level Disinfectants.''

D. What should I consider as I prepare my comments for EPA?

    The following should be considered when preparing comments for 
submission to EPA:
    1. Submission of Confidential Business Information (CBI). Do not 
submit CBI to EPA through regulations.gov or email. If submission of 
CBI is necessary, it should be mailed directly to EPA. Information that 
is claimed to be CBI should be clearly indicated. For CBI information 
submitted as a disk or CD-ROM, mark the outside of the disk or CD-ROM 
as CBI and identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to the 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Electronic access to the draft Strategy document. You may access 
the draft Strategy in regulations.gov at http://www.regulations.gov, 
under docket ID number: EPA-HQ-OPPT-2018-0265.

II. Background

A. The OIG Report: EPA Needs a Risk-Based Strategy to Assured Continued 
Effectiveness of Hospital-Level Disinfectants

    On September 19, 2016, the EPA Office of Inspector General (OIG) 
issued a report (No. 16-P-0316) titled ``EPA Needs a Risk-Based 
Strategy to Assured Continued Effectiveness of Hospital-Level 
Disinfectants.'' In this report, the OIG provided two recommendations: 
(1) Suspension of the Agency's Antimicrobial Testing Program (ATP) 
until EPA completes the reregistration process for antimicrobial 
pesticides; and (2) the development of a risk-based strategy to ensure 
the effectiveness of hospital-level disinfectants once products are in 
the marketplace.
    The OIG recommended that the strategy, at a minimum, include: (1) A 
framework for periodic testing after product registration; (2) a 
program scope that is flexible and responsive to current public health 
risks; (3) risk factors for selecting products to be tested; (4) a 
method/process for collecting samples for testing; and (5) a date to 
begin the risk-based post-registration testing. In response to the 
first recommendation, EPA suspended the ATP in November 2017.

B. How was this draft strategy developed?

    EPA developed the draft Strategy based on the general 
recommendations provided by the OIG. The Agency held a public listening 
session on June 21, 2018 to seek preliminary input from stakeholders on 
their early thoughts for the development of the draft Strategy. The 
materials presented during the listening session were published and 
made available for public comment. The materials presented during the 
listening session as well as all submitted public comments are 
available at http://www.regulations.gov, under docket ID number: EPA-
HQ-OPPT-2018-0265.

III. Overview

A. What is the antimicrobial performance evaluation program draft 
Strategy?

    This draft Strategy employs a risk-based approach to inform the 
Agency on the prioritization and selection of hospital-level 
disinfectants and associated label claims for testing. The proposed 
risk-based criteria consist of the following in order of priority: (1) 
Product label claims for specific microbes and disease prevalence data; 
(2) evaluation of uncommon label claims and unique product application 
processes; and (3) evaluation of products tested using new and/or 
recently revised methods. The following additional refinement factors 
may also be considered to further prioritize product selection and 
testing: (a) Issues identified during post-registration, product 
reregistration, and registration review; (b) trends observed under the 
previous testing program (ATP); and (c) products with high production 
volumes. Improving the product selection process and evaluating 
specific label claims of critical importance to public health are key 
features of the proposed testing program.
    The Agency is considering the following two options individually or 
in combination for obtaining samples for testing: (1) EPA purchase of 
products in the marketplace, and (2) product samples provided by the 
registrant. Several options for allocating efficacy and chemistry 
testing resources may be utilized individually or in combination; these 
options include: (1) Office of Pesticide Programs Microbiology 
Laboratory and the Analytical Chemistry Laboratory, (2) interagency 
agreements and contracts; (3) third party verification testing; and (4) 
registrant testing; and/or Data Call-Ins. EPA proposes to issue multi-
year workplans two years prior to implementation to allow for public 
review and comment. At the end of testing, the Agency will provide the 
registrant with a memo summarizing the results and next steps attached 
to the Biological Report of Analysis detailing product specific 
results. A summary table will be

[[Page 52504]]

published on the APEP website to communicate the testing results to the 
public. The Agency plans to begin implementation of the new risk-based 
testing program by 2022 when the initial round of registration review 
is completed.
    The Agency will maintain flexibility responding to evolving 
healthcare issues that may require the risk factors to be updated 
periodically as new, relevant information becomes available. The Agency 
is soliciting feedback on the proposed draft Strategy to include 
specific questions (Unit III.B). As necessary, respondents may propose 
alternatives to the recommendations described in the draft Strategy, 
and the Agency will consider them for inclusion appropriateness on a 
case-by-case basis.
    At places in these guidance documents, the Agency uses the word 
``should.'' In this document, use of ``should'' with regard to an 
action means that the action is recommended rather than required.

B. What topics is the Agency seeking public input on?

    The Agency is particularly interested in input from all interested 
stakeholders related to the following questions:
Focus Questions
    1. Please comment on the proposed risk factors and refinements, 
their proposed prioritization, their strengths and limitations, and 
recommendations for other risk factors not considered.
    2. Are the options provided for sample collection suitable for the 
purpose of the testing program, and if not, what approaches would you 
suggest to optimize sample collection. Please provide advantages and 
disadvantages to your recommendations as appropriate.
    3. Should the Agency and/or stakeholders conduct the laboratory 
evaluation (formulation chemistry and product efficacy) of disinfectant 
products? Provide examples to support your opinions and itemize 
situations where one approach would be more favorable versus the other.
    4. Please comment on the flexibility and feasibility of the example 
workplan approach (See Appendix A, draft Strategy).
    5. Please comment on the proposed communication strategy to convey 
test results to registrants and the general public including the 
preferred frequency of updates.
    6. Please provide suggested routes for resolution of efficacy 
failures. Previously, these were addressed by ``regulatory fixes'' to 
include retesting, label amendments, etc.

IV. References

    Documents that are referenced in the draft Strategy document can be 
found at http://www.regulations.gov, under docket ID number: EPA-HQ-
OPPT-2018-0265. The docket includes these documents and other 
information considered by EPA. For assistance in locating any of these 
documents, please consult the persons listed under FOR FURTHER 
INFORMATION CONTACT.
    List of Subjects: Environmental protection, Administrative practice 
and procedure, Pesticides.

    Dated: September 26, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2019-21401 Filed 10-1-19; 8:45 am]
 BILLING CODE 6560-50-P