82_FR_27367 82 FR 27254 - Final Test Guideline; Product Performance Test Guidelines; OCSPP 810.3900 Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; Notice of Availability

82 FR 27254 - Final Test Guideline; Product Performance Test Guidelines; OCSPP 810.3900 Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 113 (June 14, 2017)

Page Range27254-27255
FR Document2017-12347

EPA is announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900. This test guideline is part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. This test guideline provides guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA.

Federal Register, Volume 82 Issue 113 (Wednesday, June 14, 2017)
[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27254-27255]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12347]



[[Page 27254]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-1017; FRL-9959-78]


Final Test Guideline; Product Performance Test Guidelines; OCSPP 
810.3900 Laboratory Product Performance Testing Methods for Bed Bug 
Pesticide Products; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is announcing the availability of a final test guideline, 
Laboratory Product Performance Testing Methods for Bed Bug Pesticide 
Products; OCSPP Test Guideline 810.3900. This test guideline is part of 
a series of test guidelines established by the Office of Chemical 
Safety and Pollution Prevention (OCSPP) for use in testing pesticides 
and chemical substances. The test guidelines serve as a compendium of 
accepted scientific methodologies and protocols that are intended to 
provide data to inform regulatory decisions. This test guideline 
provides guidance for conducting a study to determine pesticide product 
performance against bed bugs, and is used by EPA, the public, and 
companies that submit data to EPA.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA is announcing the availability of a final test guideline, 
Laboratory Product Performance Testing Methods for Bed Bug Pesticide 
Products; OCSPP Test Guideline 810.3900.
    This test guideline is part of a series of test guidelines 
established by OCSPP for use in testing pesticides and chemical 
substances to develop data for submission to the agency under the 
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C. 
346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
(7 U.S.C. 136 et seq.), and the Toxic Substances Control Act (TSCA) (15 
U.S.C. 2601 et seq.). The test guidelines serve as a compendium of 
accepted scientific methodologies and protocols that are intended to 
provide data to inform regulatory decisions under TSCA, FIFRA, and/or 
FFDCA.
    The test guidelines provide guidance for conducting the test, and 
are also used by EPA, the public, and companies that are subject to 
data submission requirements under TSCA, FIFRA, and/or FFDCA. As 
guidance documents, the test guidelines are not binding on either EPA 
or any outside parties, and EPA may depart from the test guidelines 
where circumstances warrant and without prior notice. At places in this 
guidance, the agency uses the word ``should.'' In this guidance, use of 
``should'' with regard to an action means that the action is 
recommended rather than mandatory. The procedures contained in the test 
guidelines are recommended for generating the data that are the subject 
of the test guideline, but EPA recognizes that departures may be 
appropriate in specific situations. You may propose alternatives to the 
recommendations described in the test guidelines, and the agency will 
assess them for appropriateness on a case-by-case basis.

II. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this 
action may be of particular interest to those persons who are or may be 
required to conduct testing of pesticides and chemical substances for 
submission to EPA under TSCA, FIFRA, and/or FFDCA, the agency has not 
attempted to describe all the specific entities that may be affected by 
this action.

B. How can I get copies of this document and other related information?

    1. Docket for this document. The docket for this action, identified 
by docket identification (ID) number EPA-HQ-OPP-2011-1017, is available 
at http://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.
    2. Electronic access to the OCSPP test guidelines. To access OCSPP 
test guidelines electronically, please go to http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm. You may also access the test guidelines in 
http://www.regulations.gov, grouped by series under docket ID numbers: 
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-
2009-0576.

III. Overview

A. What action is EPA taking?

    EPA is announcing the availability of a final test guideline under 
Series 810.3900 entitled ``Laboratory Product Performance Testing 
Methods for Bed Bug Pesticide Products'' and identified as OCSPP Test 
Guideline 810.3900. This guideline provides recommendations for the 
design and execution of laboratory studies to evaluate the performance 
of pesticide products intended to repel, attract, and/or kill the 
common bed bug (Cimex lectularius) in connection with registration of 
pesticide products under the FIFRA (7 U.S.C. 136, et seq.). This 
guidance applies to products in any formulation such as a liquid, 
aerosol, fog, or impregnated fabric, if intended to be applied to have 
a pesticidal purpose such as to attract, repel, or kill bed bugs. It 
does not apply to repellent products applied to human skin, and does 
not apply to those products exempt from FIFRA registration under 40 CFR 
152.25.

B. How was this final test guideline developed?

    EPA-registered pesticide products are an important part of pest 
management programs for the control of bed bugs. The agency developed 
the product performance guideline to standardize the approaches to 
testing methods to ensure the quality and validity of the efficacy data 
for these types of products. The agency attended entomology and bed bug 
specific conferences, consulted with leading bed bug academics, and 
consulted peer-reviewed scientific journal articles on the issues 
associated with the guideline to draft the original document. Further, 
EPA sought advice and recommendations from the FIFRA Scientific 
Advisory Panel (SAP). The SAP meeting, held on March 6-7, 2012, was 
announced in the Federal Register issue of January 11, 2012 (77 FR 
1677) (FRL-9331-6). The guideline has been revised based on comments 
from the SAP and the public. The revisions include decreasing the 
number of individuals and replicates tested, rescinding the 
recommendation to test each field strain for its resistance ratio and 
including a resistance management statement, clarifying the agency's 
Good Laboratory Practices (GLP) requirements, reducing the recommended 
length of time

[[Page 27255]]

individuals are exposed to insecticides, recommending individuals to be 
observed up to 96 hours after treatment, and revising the statistical 
analyses recommendations.

    Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21 
U.S.C. 301 et seq.

    Dated: May 16, 2017.
Wendy C. Hamnett,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2017-12347 Filed 6-13-17; 8:45 am]
BILLING CODE 6560-50-P



                                                  27254                        Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices

                                                  ENVIRONMENTAL PROTECTION                                   The test guidelines provide guidance                access the test guidelines in http://
                                                  AGENCY                                                  for conducting the test, and are also                  www.regulations.gov, grouped by series
                                                                                                          used by EPA, the public, and companies                 under docket ID numbers: EPA–HQ–
                                                  [EPA–HQ–OPP–2011–1017; FRL–9959–78]
                                                                                                          that are subject to data submission                    OPPT–2009–0150 through EPA–HQ–
                                                  Final Test Guideline; Product                           requirements under TSCA, FIFRA, and/                   OPPT–2009–0159 and EPA–HQ–OPPT–
                                                  Performance Test Guidelines; OCSPP                      or FFDCA. As guidance documents, the                   2009–0576.
                                                  810.3900 Laboratory Product                             test guidelines are not binding on either
                                                                                                                                                                 III. Overview
                                                  Performance Testing Methods for Bed                     EPA or any outside parties, and EPA
                                                  Bug Pesticide Products; Notice of                       may depart from the test guidelines                    A. What action is EPA taking?
                                                  Availability                                            where circumstances warrant and                           EPA is announcing the availability of
                                                                                                          without prior notice. At places in this                a final test guideline under Series
                                                  AGENCY: Environmental Protection                        guidance, the agency uses the word                     810.3900 entitled ‘‘Laboratory Product
                                                  Agency (EPA).                                           ‘‘should.’’ In this guidance, use of                   Performance Testing Methods for Bed
                                                  ACTION: Notice.                                         ‘‘should’’ with regard to an action                    Bug Pesticide Products’’ and identified
                                                                                                          means that the action is recommended                   as OCSPP Test Guideline 810.3900. This
                                                  SUMMARY:    EPA is announcing the                       rather than mandatory. The procedures                  guideline provides recommendations for
                                                  availability of a final test guideline,                 contained in the test guidelines are                   the design and execution of laboratory
                                                  Laboratory Product Performance Testing                  recommended for generating the data                    studies to evaluate the performance of
                                                  Methods for Bed Bug Pesticide                           that are the subject of the test guideline,            pesticide products intended to repel,
                                                  Products; OCSPP Test Guideline                          but EPA recognizes that departures may                 attract, and/or kill the common bed bug
                                                  810.3900. This test guideline is part of                be appropriate in specific situations.                 (Cimex lectularius) in connection with
                                                  a series of test guidelines established by              You may propose alternatives to the                    registration of pesticide products under
                                                  the Office of Chemical Safety and                       recommendations described in the test                  the FIFRA (7 U.S.C. 136, et seq.). This
                                                  Pollution Prevention (OCSPP) for use in                 guidelines, and the agency will assess                 guidance applies to products in any
                                                  testing pesticides and chemical                         them for appropriateness on a case-by-                 formulation such as a liquid, aerosol,
                                                  substances. The test guidelines serve as                case basis.                                            fog, or impregnated fabric, if intended to
                                                  a compendium of accepted scientific                                                                            be applied to have a pesticidal purpose
                                                  methodologies and protocols that are                    II. General Information
                                                                                                                                                                 such as to attract, repel, or kill bed bugs.
                                                  intended to provide data to inform                      A. Does this action apply to me?                       It does not apply to repellent products
                                                  regulatory decisions. This test guideline                                                                      applied to human skin, and does not
                                                                                                            This action is directed to the public
                                                  provides guidance for conducting a                                                                             apply to those products exempt from
                                                                                                          in general. Although this action may be
                                                  study to determine pesticide product                                                                           FIFRA registration under 40 CFR
                                                                                                          of particular interest to those persons
                                                  performance against bed bugs, and is                                                                           152.25.
                                                                                                          who are or may be required to conduct
                                                  used by EPA, the public, and companies
                                                                                                          testing of pesticides and chemical
                                                  that submit data to EPA.                                                                          B. How was this final test guideline
                                                                                                          substances for submission to EPA under
                                                  FOR FURTHER INFORMATION CONTACT:                                                                  developed?
                                                                                                          TSCA, FIFRA, and/or FFDCA, the
                                                  Michael L. Goodis, P.E., Registration                   agency has not attempted to describe all     EPA-registered pesticide products are
                                                  Division (7505P), Office of Pesticide                   the specific entities that may be affectedan important part of pest management
                                                  Programs, Environmental Protection                      by this action.                           programs for the control of bed bugs.
                                                  Agency, 1200 Pennsylvania Ave. NW.,                                                               The agency developed the product
                                                  Washington, DC 20460–0001; telephone                    B. How can I get copies of this document performance guideline to standardize
                                                  number: (703) 305–7090; email address:                  and other related information?            the approaches to testing methods to
                                                  RDFRNotices@epa.gov.                                       1. Docket for this document. The       ensure the quality and validity of the
                                                  SUPPLEMENTARY INFORMATION:                              docket for this action, identified by     efficacy data for these types of products.
                                                                                                          docket identification (ID) number EPA– The agency attended entomology and
                                                  I. Introduction                                         HQ–OPP–2011–1017, is available at         bed bug specific conferences, consulted
                                                     EPA is announcing the availability of                http://www.regulations.gov or at the      with leading bed bug academics, and
                                                  a final test guideline, Laboratory                      Office of Pesticide Programs Regulatory   consulted peer-reviewed scientific
                                                  Product Performance Testing Methods                     Public Docket (OPP Docket) in the         journal articles on the issues associated
                                                  for Bed Bug Pesticide Products; OCSPP                   Environmental Protection Agency           with the guideline to draft the original
                                                  Test Guideline 810.3900.                                Docket Center (EPA/DC), West William      document. Further, EPA sought advice
                                                     This test guideline is part of a series              Jefferson Clinton Bldg., Rm. 3334, 1301   and recommendations from the FIFRA
                                                  of test guidelines established by OCSPP                 Constitution Ave. NW., Washington, DC Scientific Advisory Panel (SAP). The
                                                  for use in testing pesticides and                       20460–0001. The Public Reading Room       SAP meeting, held on March 6–7, 2012,
                                                  chemical substances to develop data for                 is open from 8:30 a.m. to 4:30 p.m.,      was announced in the Federal Register
                                                  submission to the agency under the                      Monday through Friday, excluding legal issue of January 11, 2012 (77 FR 1677)
                                                  Federal Food, Drug, and Cosmetic Act                    holidays. The telephone number for the (FRL–9331–6). The guideline has been
                                                  (FFDCA) section 408 (21 U.S.C. 346a),                   Public Reading Room is (202) 566–1744, revised based on comments from the
                                                  the Federal Insecticide, Fungicide, and                 and the telephone number for the OPP      SAP and the public. The revisions
                                                  Rodenticide Act (FIFRA) (7 U.S.C. 136                   Docket is (703) 305–5805. Please review include decreasing the number of
                                                  et seq.), and the Toxic Substances                      the visitor instructions and additional   individuals and replicates tested,
mstockstill on DSK30JT082PROD with NOTICES




                                                  Control Act (TSCA) (15 U.S.C. 2601 et                   information about the docket available    rescinding the recommendation to test
                                                  seq.). The test guidelines serve as a                   at http://www.epa.gov/dockets.            each field strain for its resistance ratio
                                                  compendium of accepted scientific                          2. Electronic access to the OCSPP test and including a resistance management
                                                  methodologies and protocols that are                    guidelines. To access OCSPP test          statement, clarifying the agency’s Good
                                                  intended to provide data to inform                      guidelines electronically, please go to   Laboratory Practices (GLP)
                                                  regulatory decisions under TSCA,                        http://www.epa.gov/ocspp/pubs/frs/        requirements, reducing the
                                                  FIFRA, and/or FFDCA.                                    home/testmeth.htm. You may also           recommended length of time


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                                                                               Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices                                                  27255

                                                  individuals are exposed to insecticides,                questions on document availability, or if              party human subjects research that are
                                                  recommending individuals to be                          you do not have access to the Internet,                submitted to the Office of Pesticide
                                                  observed up to 96 hours after treatment,                consult with the DFO, Jim Downing                      Programs (OPP) to be used for regulatory
                                                  and revising the statistical analyses                   listed under FOR FURTHER INFORMATION                   purposes.
                                                  recommendations.                                        CONTACT.                                                  Topic for discussion. On Wednesday,
                                                    Authority: 7 U.S.C. 136 et seq.; 15 U.S.C.
                                                                                                             Special accommodations. For                         July 26, 2017, EPA’s Human Studies
                                                  2601 et seq.; 21 U.S.C. 301 et seq.                     information on access or services for                  Review Board will consider one topic:
                                                                                                          individuals with disabilities, or to                   Field evaluation of three topically
                                                    Dated: May 16, 2017.                                  request accommodation of a disability,                 applied insect repellent products
                                                  Wendy C. Hamnett,                                       please contact the DFO listed under FOR                containing IR3535 against mosquitoes in
                                                  Acting Assistant Administrator, Office of               FURTHER INFORMATION CONTACT at least                   Florida.
                                                  Chemical Safety and Pollution Prevention.               10 days prior to the meeting to give EPA                  The Agenda and meeting materials for
                                                  [FR Doc. 2017–12347 Filed 6–13–17; 8:45 am]             as much time as possible to process                    this topic will be available in advance
                                                  BILLING CODE 6560–50–P                                  your request.                                          of the meeting at https://www2.epa.gov/
                                                                                                                                                                 osa/human-studies-review-board.
                                                                                                          How may I participate in this meeting?                    On September 15, 2017, the Human
                                                  ENVIRONMENTAL PROTECTION                                   The HSRB encourages the public’s                    Studies Review Board will review and
                                                  AGENCY                                                  input. You may participate in these                    finalize their draft Final Report from the
                                                                                                          meetings by following the instructions                 July 26, 2017 meeting, in addition to
                                                  [FRL–9963–68–ORD]
                                                                                                          in this section.                                       other topics that may come before the
                                                  Human Studies Review Board;                                1. Oral comments. Requests to present               Board. The HSRB may also discuss
                                                  Notification of Public Meetings                         oral comments during either meeting                    planning for future HSRB meetings. The
                                                                                                          will be accepted up to Noon Eastern                    agenda and the draft report will be
                                                  AGENCY: Environmental Protection                        Time on Wednesday, July 19, 2017, for                  available prior to the teleconference at
                                                  Agency (EPA).                                           the July 26, 2017 meeting and up to                    https://www2.epa.gov/osa/human-
                                                  ACTION: Notice.                                         Noon Eastern Time on Friday,                           studies-review-board.
                                                                                                          September 8, 2017 for the September 15,                   Meeting minutes and final reports.
                                                  SUMMARY:   The Environmental Protection                 2017 teleconference. To the extent that                Minutes of these meetings, summarizing
                                                  Agency (EPA), Office of the Science                     time permits, interested persons who                   the matters discussed and
                                                  Advisor announces two separate public                   have not pre-registered may be                         recommendations made by the HSRB,
                                                  meetings of the Human Studies Review                    permitted by the HSRB Chair to present                 will be released within 90 calendar days
                                                  Board (HSRB) to advise the Agency on                    oral comments during either meeting at                 of the meeting. These minutes will be
                                                  the ethical and scientific review of                    the designated time on the agenda. Oral                available at https://www2.epa.gov/osa/
                                                  research involving human subjects.                      comments before the HSRB are                           human-studies-review-board. In
                                                  DATES: A virtual public meeting will be                 generally limited to five minutes per                  addition, information regarding the
                                                  held on Wednesday, July 26, 2017, from                  individual or organization. If additional              HSRB’s Final Report, will be found at
                                                  1:00 p.m. to approximately 5:00 p.m.                    time is available, further public                      https://www2.epa.gov/osa/human-
                                                  Eastern Time. A separate, subsequent                    comments may be possible.                              studies-review-board or from Jim
                                                  teleconference meeting is planned for                      2. Written comments. Submit your                    Downing listed under FOR FURTHER
                                                  Friday, September 15, 2017, from 2:00                   written comments prior to the meetings.                INFORMATION CONTACT.
                                                  p.m. to approximately 3:30 p.m. Eastern                 For the Board to have the best
                                                                                                                                                                 Robert J. Kavlock,
                                                  Time for the HSRB to finalize its Final                 opportunity to review and consider your
                                                                                                                                                                 EPA Science Advisor.
                                                  Report of the July 26, 2017 meeting and                 comments as it deliberates, you should
                                                                                                          submit your comments by Noon Eastern                   [FR Doc. 2017–12345 Filed 6–13–17; 8:45 am]
                                                  review other possible topics.
                                                  ADDRESSES: Both of these meetings will
                                                                                                          Time on Wednesday, July 19 2016, for                   BILLING CODE 6560–50–P

                                                  be conducted entirely by telephone and                  the July 26, 2017 meeting, and by noon
                                                  on the Internet using Adobe Connect.                    Eastern Time on Friday, September 8,
                                                                                                          2017 for the September 15, 2017                        FEDERAL MARITIME COMMISSION
                                                  For detailed access information visit the
                                                  HSRB Web site: https://www2.epa.gov/                    teleconference. If you submit comments                 [Docket No. 17–06]
                                                  osa/human-studies-review-board                          after these dates, those comments will
                                                                                                          be provided to the HSRB members, but                   Notice of Filing of Complaint and
                                                  FOR FURTHER INFORMATION CONTACT: Any
                                                                                                          you should recognize that the HSRB                     Assignment: Tarik Afif Chaouch v.
                                                  member of the public who wishes to                      members may not have adequate time to                  Demetrios Air Freight Co., Demetrios
                                                  receive further information should                      consider your comments prior to their                  International Shipping Co., Inc., and
                                                  contact the HSRB Designated Federal                     discussion. You should submit your                     Troy Container Line Ltd
                                                  Official (DFO), Jim Downing on                          comments to the DFO, Jim Downing
                                                  telephone number (202) 564–2468; fax                    listed under FOR FURTHER INFORMATION                     Notice is given that a complaint has
                                                  number: (202) 564–2070; email address:                  CONTACT. There is no limit on the length               been filed with the Federal Maritime
                                                  downing.jim@epa.gov; or mailing                         of written comments for consideration                  Commission (Commission) by Tarik Afif
                                                  address: Environmental Protection                       by the HSRB.                                           Chaouch, hereinafter ‘‘Complainant,’’
                                                  Agency, Office of the Science Advisor,                                                                         against Demetrios Air Freight Co.,
                                                  Mail code 8105R, 1200 Pennsylvania                      Background                                             Demetrios International Shipping Co.,
mstockstill on DSK30JT082PROD with NOTICES




                                                  Avenue NW., Washington, DC 20460.                         The HSRB is a Federal advisory                       Inc., and Troy Container Line LTD,
                                                  SUPPLEMENTARY INFORMATION:                              committee operating in accordance with                 hereinafter ‘‘Respondents.’’
                                                    Meeting access: These meetings are                    the Federal Advisory Committee Act 5                   Complainant states it hired the
                                                  open to the public. The full Agenda and                 U.S.C. App.2 section 9. The HSRB                       Respondents to ship two cars to Algiers,
                                                  meeting materials are available at the                  provides advice, information, and                      Algeria.
                                                  HSRB Web site: https://www2.epa.gov/                    recommendations on issues related to                     Complainant alleges that due to an
                                                  osa/human-studies-review-board . For                    scientific and ethical aspects of third-               error the Respondents made on the bill


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Document Created: 2017-06-14 01:23:47
Document Modified: 2017-06-14 01:23:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactMichael L. Goodis, P.E., Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation82 FR 27254 

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