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]
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52502
Federal Register / Vol. 84, No. 191 / Wednesday, October 2, 2019 / Notices
must file in accordance with Rules 211
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(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]
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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
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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
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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
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general circulation. Any request for a
public hearing shall include the
following information: the name,
address, and telephone number of the
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the requesting person’s interest in the
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and a brief statement of the information
that the requesting person intends to
submit at such hearing; and the
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the signature of a responsible official of
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If EPA Region 5 does not receive a
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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]
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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
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
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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
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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.
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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]
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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
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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]
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