Antimicrobial Performance Evaluation Program (APEP): Draft Risk-Based Strategy To Ensure the Effectiveness of Hospital-Level Disinfectants; Notice of Availability and Request for Comments, 52502-52504 [2019-21401]

Download as PDF 52502 Federal Register / Vol. 84, No. 191 / Wednesday, October 2, 2019 / Notices must file in accordance with Rules 211 and 214 of the Commission’s Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding. eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: https://www.ferc.gov/ docs-filing/efiling/filing-req.pdf. For other information, call (866) 208–3676 (toll free). For TTY, call (202) 502–8659. Dated: September 26, 2019. Nathaniel J. Davis Sr., Deputy Secretary. [FR Doc. 2019–21407 Filed 10–1–19; 8:45 am] BILLING CODE 6717–01–P ENVIRONMENTAL PROTECTION AGENCY [FRL–10000–70–Region 5] Public Water System Supervision Program Approval for the State of Minnesota Environmental Protection Agency (EPA). ACTION: Notice of tentative approval. Notice is hereby given that the Environmental Protection Agency (EPA) has tentatively approved a revision to the state of Minnesota’s Public Water System Supervision Program under the federal Safe Drinking Water Act (SDWA) by adopting the Revised Total Coliform Rule. The EPA has determined that this revision is no less stringent than the corresponding federal regulation. Therefore, the EPA intends to approve this revision to the state of Minnesota’s Public Water System Supervision Program, thereby giving Minnesota Department of Health primary enforcement responsibility for this regulation. This approval action does not extend to public water systems in Indian Country. By approving this rule, EPA does not intend to affect the rights of federally recognized Indian Tribes in Minnesota, nor does it intend to limit existing rights of the State of Minnesota. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: Any interested party may request a public hearing on this determination. A request for a public hearing must be submitted by November 1, 2019. The EPA Region 5 Administrator may deny frivolous or insubstantial requests for a hearing. However, if a substantial request for a public hearing is made by VerDate Sep<11>2014 16:42 Oct 01, 2019 Jkt 250001 All documents relating to this determination are available for inspection at the following offices between the hours of 9 a.m. and 4 p.m., Monday through Friday, except for official holidays: Minnesota Department of Health, Drinking Water Protection Section, 625 N Robert St., St. Paul, MN 55164; and the U.S. Environmental Protection Agency Region 5, Ground Water and Drinking Water Branch (WG– 15J), 77 W Jackson Blvd., Chicago, IL 60604. ADDRESSES: AGENCY: DATES: November 1, 2019, EPA Region 5 will hold a public hearing, and a notice of such hearing will be published in the Federal Register and a newspaper of general circulation. Any request for a public hearing shall include the following information: the name, address, and telephone number of the individual, organization, or other entity requesting a hearing; a brief statement of the requesting person’s interest in the Regional Administrator’s determination and a brief statement of the information that the requesting person intends to submit at such hearing; and the signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity. If EPA Region 5 does not receive a timely and appropriate request for a hearing and the Regional Administrator does not elect to hold a hearing on her own motion, this determination shall become final and effective on November 1, 2019 and no further public notice will be issued. FOR FURTHER INFORMATION CONTACT: Janet Kuefler, EPA Region 5, Ground Water and Drinking Water Branch, at the address given above, by telephone at 312–886–0123, or at kuefler.janet@ epa.gov. Authority: Section 1413 of the Safe Drinking Water Act, 42 U.S.C. 300g–2, and the federal regulations implementing Section 1413 of the Act set forth at 40 CFR part 142. Dated: September 18, 2019. Cheryl Newton, Acting Regional Administrator, Region 5. [FR Doc. 2019–21467 Filed 10–1–19; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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: https:// 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For general information contact: Kristen Willis, Antimicrobials Division (7510P), Office of Pesticide Programs, SUMMARY: E:\FR\FM\02OCN1.SGM 02OCN1 Federal Register / Vol. 84, No. 191 / Wednesday, October 2, 2019 / Notices 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 HospitalLevel Disinfectants.’’ khammond on DSKJM1Z7X2PROD with NOTICES 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 VerDate Sep<11>2014 16:42 Oct 01, 2019 Jkt 250001 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 https://www.epa.gov/dockets/ comments.html. 3. Electronic access to the draft Strategy document. You may access the draft Strategy in regulations.gov at https://www.regulations.gov, under docket ID number: EPA–HQ–OPPT– 2018–0265. II. Background A. The OIG Report: EPA Needs a RiskBased 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 HospitalLevel 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, PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 52503 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 https:// 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 riskbased 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 E:\FR\FM\02OCN1.SGM 02OCN1 52504 Federal Register / Vol. 84, No. 191 / Wednesday, October 2, 2019 / Notices 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. khammond on DSKJM1Z7X2PROD with NOTICES 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. VerDate Sep<11>2014 16:42 Oct 01, 2019 Jkt 250001 IV. References Documents that are referenced in the draft Strategy document can be found at https://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 FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Notice of Issuance of Statement of Federal Financial Accounting Standards 57, Omnibus Amendments 2019 Federal Accounting Standards Advisory Board. AGENCY: ACTION: Notice. Pursuant to 31 U.S.C. 3511(d), the Federal Advisory Committee Act (Pub. L. 92–463), as amended, and the FASAB Rules Of Procedure, as amended in October 2010, notice is hereby given that the Federal Accounting Standards Advisory Board (FASAB) has issued Statement of Federal Financial Accounting Standards 57, Omnibus Amendments 2019. The Statement is available on the FASAB website at https:// www.fasab.gov/accounting-standards/. Copies can be obtained by contacting FASAB at (202) 512–7350. Ms. Monica R. Valentine, Executive Director, 441 G Street, NW, Suite 1155, Washington, DC 20548, or call (202) 512–7350. FOR FURTHER INFORMATION CONTACT: Authority: Federal Advisory Committee Act, Pub. L. 92–463. Dated: September 27, 2019. Monica R. Valentine, Executive Director. [FR Doc. 2019–21451 Filed 10–1–19; 8:45 am] BILLING CODE 1610–01–P PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 FEDERAL COMMUNICATIONS COMMISSION [OMB 3060–0288] Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority Federal Communications Commission. ACTION: Notice and request for comments. AGENCY: As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission’s burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number. DATES: Written comments shall be submitted on or before December 2, 2019. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible. SUMMARY: Direct all PRA comments to Cathy Williams, FCC, via email: PRA@ fcc.gov and to Cathy.Williams@fcc.gov. FOR FURTHER INFORMATION CONTACT: For additional information about the information collection, contact Cathy Williams at (202) 418–2918. SUPPLEMENTARY INFORMATION: OMB Control Number: 3060–0288. ADDRESSES: E:\FR\FM\02OCN1.SGM 02OCN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://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: [email protected].
    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: 
[email protected].

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 https://www.epa.gov/dockets/comments.html.
    3. Electronic access to the draft Strategy document. You may access 
the draft Strategy in regulations.gov at https://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 https://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 https://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


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