80_FR_34754 80 FR 34638 - Draft Test Guidelines; Series 810-Product Performance Test Guidelines; Notice of Availability and Request for Comments

80 FR 34638 - Draft Test Guidelines; Series 810-Product Performance Test Guidelines; Notice of Availability and Request for Comments

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 116 (June 17, 2015)

Page Range34638-34639
FR Document2015-14955

This notice announces the availability for comment of several 810 series, non-binding, draft test guidelines developed by the Office of Chemical Safety and Pollution Prevention (OCSPP). The test guidelines provide guidance on conducting testing by the public and companies that are subject to EPA data submission requirements under OCSPP's major statutory mandates.

Federal Register, Volume 80 Issue 116 (Wednesday, June 17, 2015)
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34638-34639]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14955]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0276; FRL-9927-37]


Draft Test Guidelines; Series 810--Product Performance Test 
Guidelines; Notice of Availability and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability for comment of several 
810 series, non-binding, draft test guidelines developed by the Office 
of Chemical Safety and Pollution Prevention (OCSPP). The test 
guidelines provide guidance on conducting testing by the public and 
companies that are subject to EPA data submission requirements under 
OCSPP's major statutory mandates.

DATES: Comments must be received on or before August 17, 2015.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2015-0276, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Melissa

[[Page 34639]]

Chun, Regulatory Coordination Staff (7101M), Office of Chemical Safety 
and Pollution Prevention, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-1605; email address: chun.melissa@epa.gov.
    For technical information contact: Stephen Tomasino, Biological and 
Economic Analysis Division (7503P), Office of Pesticide Programs, 
Environmental Protection Agency, Environmental Science Center, 701 
Mapes Road, Ft. Meade, MD 20755-5350; telephone number: (410) 305-2976; 
email address: tomasino.stephen@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. 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 other chemical substances 
for submission of data to EPA under the Toxic Substances Control Act 
(TSCA), 15 U.S.C. 2601 et seq., the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., and/or the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, the Agency has not 
attempted to describe all the specific entities that may be affected by 
this action. If you have any questions regarding the applicability of 
this action to a particular entity, consult the technical person listed 
under FOR FURTHER INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed CBI. In addition to one complete 
version of the comment that includes information claimed as CBI, a copy 
of the comment that does not contain the information claimed as CBI 
must be submitted for inclusion in the public docket. Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Electronic access to the OCSPP Test Guidelines. You may access 
the guidelines in regulations.gov at 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.

II. Background

    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 these guidance documents, the Agency uses the word 
``should.'' In these guidance documents, 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 
guidelines, 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.

III. What action is EPA taking?

    EPA is making available for comment the following 810 Series draft 
test guidelines: OCSPP Test Guideline 810.2000--General Considerations 
for Testing Antimicrobial Agents, OCSPP Test Guideline 810.2100--
Sterilants & Sporicides Recommendations for Efficacy Testing, and OCSPP 
Test Guideline 810.2200--Disinfectants for Use on Hard Surfaces--
Efficacy Data Recommendations.
    The Agency published the notice announcing the final test 
guidelines for these product performance testing guidelines for 
antimicrobial agents in the Federal Register of March 16, 2012 (77 FR 
15750) (FRL-9332-4). Since then, the Agency has received information 
from the users that these test guidelines are confusing and in some 
cases, inaccurate. The test guidelines have been re-formatted to be 
more user friendly, correct technical information, and include updates 
from policy documents published after 2012. As noted in section I.B.3 
of this notice, the public can access the guidelines in regulations.gov 
at 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.

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

    Dated: June 4, 2015.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2015-14955 Filed 6-16-15; 8:45 am]
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                                                    34638                        Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

                                                    cyanobacterial toxins in drinking water.                potential impacts on drinking water and                cylindrospermopsin. It provides
                                                    Additionally, EPA announces a support                   the potential to affect human health.                  information and a framework that PWSs
                                                    document for states and utilities to                                                                           and others (as appropriate) can consider
                                                                                                            III. What are EPA’s Health Advisories?
                                                    assist them as they consider whether                                                                           to inform their decisions on managing
                                                    and how to manage cyanobacterial                           Under the Safe Drinking Water Act,                  the risks from cyanotoxins to drinking
                                                    toxins in drinking water. The                           EPA may publish Health Advisories                      water.
                                                    recommendations in this document are                    (HAs) for contaminants that are not
                                                                                                                                                                     Dated: June 10, 2015.
                                                    intended to assist public drinking water                subject to any national primary drinking
                                                                                                                                                                   Kenneth J. Kopocis,
                                                    systems (PWSs) manage the risks from                    water regulation. 42 U.S.C. 300 g–
                                                                                                            1(b)(1)(F). EPA develops HAs to provide                Deputy Assistant Administrator, Office of
                                                    cyanobacterial toxins in drinking water,                                                                       Water.
                                                    including information and a framework                   information on the chemical and
                                                                                                            physical properties, occurrence and                    [FR Doc. 2015–14936 Filed 6–16–15; 8:45 am]
                                                    that PWSs can consider in their
                                                                                                            exposure, health effects, quantification               BILLING CODE 6560–50–P
                                                    cyanotoxin risk management efforts.
                                                    FOR FURTHER INFORMATION CONTACT: For                    of toxicological effects, other regulatory
                                                    information regarding the HAs or                        standards, analytical methods, and
                                                                                                            treatment technology for drinking water                ENVIRONMENTAL PROTECTION
                                                    HESDs: Lesley D’Anglada, Office of                                                                             AGENCY
                                                    Water, Health and Ecological Criteria                   contaminants. HAs describe
                                                    Division (4304T), Environmental                         concentrations of drinking water                       [EPA–HQ–OPP–2015–0276; FRL–9927–37]
                                                    Protection Agency, 1200 Pennsylvania                    contaminants at which adverse health
                                                                                                            effects are not anticipated to occur over              Draft Test Guidelines; Series 810—
                                                    Avenue NW., Washington, DC 20460;
                                                                                                            specific exposure durations (e.g., one-                Product Performance Test Guidelines;
                                                    telephone number: (202) 566–1125;
                                                                                                            day, ten-days, several years, and a                    Notice of Availability and Request for
                                                    email address: danglada.lesley@epa.gov.
                                                                                                            lifetime). HAs also contain a margin of                Comments
                                                    For information regarding
                                                    recommendations for cyanotoxin                          safety to address database uncertainties.              AGENCY: Environmental Protection
                                                    management in drinking water: Hannah                    HAs serve as informal technical                        Agency (EPA).
                                                    Holsinger, Office of Water, Office of                   guidance to assist federal, state and
                                                                                                                                                                   ACTION: Notice.
                                                    Ground Water and Drinking Water                         local officials, as well as managers of
                                                    (4607M), Environmental Protection                       public or community water systems in                   SUMMARY:   This notice announces the
                                                    Agency, 1200 Pennsylvania Avenue                        protecting public health when                          availability for comment of several 810
                                                    NW., Washington, DC 20460; telephone                    emergency spills or contamination                      series, non-binding, draft test guidelines
                                                    number: (202) 564–0403; email address:                  situations occur. They are not                         developed by the Office of Chemical
                                                    holsinger.hannah@epa.gov.                               regulations and should not be construed                Safety and Pollution Prevention
                                                                                                            as legally enforceable federal standards.              (OCSPP). The test guidelines provide
                                                    SUPPLEMENTARY INFORMATION:
                                                                                                            HAs may change as new information                      guidance on conducting testing by the
                                                    I. General Information                                  becomes available.                                     public and companies that are subject to
                                                    A. How can I get copies of this                         IV. Information on EPA’s Ten-Day                       EPA data submission requirements
                                                    document and other related                              Health Advisories for the                              under OCSPP’s major statutory
                                                    information?                                            Cyanobacterial Toxins,                                 mandates.
                                                      1. Electronic Access. You may access                  Cylindrospermopsin and Microcystins                    DATES: Comments must be received on
                                                    this Federal Register document                             Today, EPA is making available the                  or before August 17, 2015.
                                                    electronically from the Government                      HA values for the cyanobacterial toxins                ADDRESSES: Submit your comments,
                                                    Printing Office under the ‘‘Federal                     microcystins and cylindrospermopsin.                   identified by docket identification (ID)
                                                    Register’’ listings at FDSys (http://                   EPA recommends 0.3 micrograms per                      number EPA–HQ–OPP–2015–0276, by
                                                    www.gpo.gov/fdsys/browse/                               liter for microcystins and 0.7                         one of the following methods:
                                                    collection.action?collectionCode=FR).                   micrograms per liter for                                 • Federal eRulemaking Portal: http://
                                                    The Health Effects Support Documents                    cylindrospermopsin as levels not to be                 www.regulations.gov. Follow the online
                                                    and the Health Advisories for the                       exceeded in drinking water for bottle-                 instructions for submitting comments.
                                                    cyanobacterial toxins are available on                  fed infants and young children of pre-                 Do not submit electronically any
                                                    EPA’s Web site at http://water.epa.gov/                 school age. For school-age children                    information you consider to be
                                                    drink/standards/hascience.cfm. The                      through adults, the health advisory                    Confidential Business Information (CBI)
                                                    Recommendations for Public Water                        values for drinking water are 1.6                      or other information whose disclosure is
                                                    Systems to Manage Cyanotoxins in                        micrograms per liter for microcystins                  restricted by statute.
                                                    Drinking Water document is available                    and 3 micrograms per liter for                           • Mail: OPP Docket, Environmental
                                                    on EPA’s Web site at http://                            cylindrospermopsin. The HA values are                  Protection Agency Docket Center (EPA/
                                                    www2.epa.gov/nutrient-policy-data/                      based on exposure for ten days.                        DC), (28221T), 1200 Pennsylvania Ave.
                                                    guidelines-and-recommendations.                                                                                NW., Washington, DC 20460–0001.
                                                                                                            V. Information on EPA’s Support                          • Hand Delivery: To make special
                                                    II. What are cyanobacterial toxins and                  Document To Assist States and Utilities                arrangements for hand delivery or
                                                    how are they produced?                                  in Managing Cyanobacterial Toxins                      delivery of boxed information, please
                                                       Algae and cyanobacteria are natural                     EPA also announces the release of a                 follow the instructions at http://
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    components of fresh water; however,                     cyanotoxin management document that                    www.epa.gov/dockets/contacts.html.
                                                    under favorable conditions, they can                    is a companion to the HAs for                          Additional instructions on commenting
                                                    rapidly multiply causing ‘‘blooms.’’                    microcystins and cylindrospermopsin.                   or visiting the docket, along with more
                                                    Some cyanobacterial species can                         The document is intended to assist                     information about dockets generally, is
                                                    produce toxins (cyanotoxins) at levels                  PWSs that choose to develop system-                    available at http://www.epa.gov/
                                                    that may be of concern for human                        specific plans for evaluating their source             dockets.
                                                    health. These cyanobacterial toxins are                 waters for vulnerability to                            FOR FURTHER INFORMATION CONTACT: For
                                                    of particular concern because of their                  contamination by microcystins and                      general information contact: Melissa


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                                                                                 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices                                                  34639

                                                    Chun, Regulatory Coordination Staff                     http://www.epa.gov/dockets/                            more user friendly, correct technical
                                                    (7101M), Office of Chemical Safety and                  comments.html.                                         information, and include updates from
                                                    Pollution Prevention, Environmental                       3. Electronic access to the OCSPP Test               policy documents published after 2012.
                                                    Protection Agency, 1200 Pennsylvania                    Guidelines. You may access the                         As noted in section I.B.3 of this notice,
                                                    Ave. NW., Washington, DC 20460–0001;                    guidelines in regulations.gov at http://               the public can access the guidelines in
                                                    telephone number: (202) 564–1605;                       www.regulations.gov, grouped by series                 regulations.gov at http://
                                                    email address: chun.melissa@epa.gov.                    under docket ID numbers: EPA–HQ–                       www.regulations.gov, grouped by series
                                                       For technical information contact:                   OPPT–2009–0150 through EPA–HQ–                         under docket ID numbers: EPA–HQ–
                                                    Stephen Tomasino, Biological and                        OPPT–2009–0159, and EPA–HQ–OPPT–                       OPPT–2009–0150 through EPA–HQ–
                                                    Economic Analysis Division (7503P),                     2009–0576.                                             OPPT–2009–0159, and EPA–HQ–OPPT–
                                                    Office of Pesticide Programs,                           II. Background                                         2009–0576.
                                                    Environmental Protection Agency,                                                                                 Authority: 7 U.S.C. 136 et seq.; 15 U.S.C.
                                                                                                               The test guidelines serve as a
                                                    Environmental Science Center, 701                                                                              2601 et seq.; 21 U.S.C. 301 et seq.
                                                                                                            compendium of accepted scientific
                                                    Mapes Road, Ft. Meade, MD 20755–                                                                                 Dated: June 4, 2015.
                                                                                                            methodologies and protocols that are
                                                    5350; telephone number: (410) 305–
                                                                                                            intended to provide data to inform                     James Jones,
                                                    2976; email address: tomasino.stephen@
                                                                                                            regulatory decisions under TSCA,                       Assistant Administrator, Office of Chemical
                                                    epa.gov.                                                FIFRA, and/or FFDCA. The test                          Safety and Pollution Prevention.
                                                    SUPPLEMENTARY INFORMATION:                              guidelines provide guidance for                        [FR Doc. 2015–14955 Filed 6–16–15; 8:45 am]
                                                    I. General Information                                  conducting the test, and are also used by              BILLING CODE 6560–50–P
                                                                                                            EPA, the public, and companies that are
                                                    A. Does this action apply to me?                        subject to data submission requirements
                                                                                                            under TSCA, FIFRA, and/or FFDCA.                       FEDERAL DEPOSIT INSURANCE
                                                       This action is directed to the public
                                                                                                               As guidance documents, the test                     CORPORATION
                                                    in general. Although this action may be
                                                                                                            guidelines are not binding on either
                                                    of particular interest to those persons
                                                                                                            EPA or any outside parties, and EPA                    Agency Information Collection
                                                    who are or may be required to conduct
                                                                                                            may depart from the test guidelines                    Activities: Proposed Collection
                                                    testing of pesticides and other chemical
                                                                                                            where circumstances warrant and                        Renewals; Comment Request
                                                    substances for submission of data to
                                                                                                            without prior notice. At places in these
                                                    EPA under the Toxic Substances
                                                                                                            guidance documents, the Agency uses                    Federal Deposit Insurance Corporation
                                                    Control Act (TSCA), 15 U.S.C. 2601 et
                                                                                                            the word ‘‘should.’’ In these guidance                 (FDIC).
                                                    seq., the Federal Insecticide, Fungicide,
                                                                                                            documents, use of ‘‘should’’ with regard
                                                    and Rodenticide Act (FIFRA), 7 U.S.C.                                                                          ACTION:   Notice and request for comment.
                                                                                                            to an action means that the action is
                                                    136 et seq., and/or the Federal Food,
                                                                                                            recommended rather than mandatory.                     SUMMARY:   The FDIC, as part of its
                                                    Drug, and Cosmetic Act (FFDCA), 21
                                                                                                            The procedures contained in the test                   continuing effort to reduce paperwork
                                                    U.S.C. 346a, the Agency has not
                                                                                                            guidelines are recommended for                         and respondent burden, invites the
                                                    attempted to describe all the specific
                                                                                                            generating the data that are the subject               general public and other Federal
                                                    entities that may be affected by this
                                                                                                            of the test guidelines, but EPA                        agencies to take this opportunity to
                                                    action. If you have any questions
                                                                                                            recognizes that departures may be                      comment on the renewal of existing
                                                    regarding the applicability of this action
                                                                                                            appropriate in specific situations. You                collections of information, as required
                                                    to a particular entity, consult the
                                                                                                            may propose alternatives to the                        by the Paperwork Reduction Act of
                                                    technical person listed under FOR
                                                                                                            recommendations described in the test                  1995. On April 10, 2015, (80 FR 19318),
                                                    FURTHER INFORMATION CONTACT.
                                                                                                            guidelines, and the Agency will assess                 the FDIC requested comment for 60 days
                                                    B. What should I consider as I prepare                  them for appropriateness on a case-by-                 on a proposal to renew the following
                                                    my comments for EPA?                                    case basis.                                            collections of information: (1)
                                                       1. Submitting CBI. Do not submit this                III. What action is EPA taking?                        Recordkeeping and Confirmation
                                                    information to EPA through                                 EPA is making available for comment                 Requirements for Securities
                                                    regulations.gov or email. Clearly mark                  the following 810 Series draft test                    Transactions (3064–0028); (2)
                                                    the part or all of the information that                 guidelines: OCSPP Test Guideline                       Interagency Notice of Change in Director
                                                    you claim to be CBI. For CBI                            810.2000—General Considerations for                    or Executive Officer (3064–0097); (3)
                                                    information in a disk or CD–ROM that                    Testing Antimicrobial Agents, OCSPP                    Certification of Compliance with
                                                    you mail to EPA, mark the outside of the                Test Guideline 810.2100—Sterilants &                   Mandatory Bars to Employment (3064–
                                                    disk or CD–ROM as CBI and then                          Sporicides Recommendations for                         0121); (4) Customer Assistance (3064–
                                                    identify electronically within the disk or              Efficacy Testing, and OCSPP Test                       0134); and, (5) Notice Regarding
                                                    CD–ROM the specific information that                    Guideline 810.2200—Disinfectants for                   Assessment Credits (3064–0151). No
                                                    is claimed CBI. In addition to one                      Use on Hard Surfaces—Efficacy Data                     comments were received. The FDIC
                                                    complete version of the comment that                    Recommendations.                                       hereby gives notice of its plan to submit
                                                    includes information claimed as CBI, a                     The Agency published the notice                     to OMB a request to approve the
                                                    copy of the comment that does not                       announcing the final test guidelines for               renewal of these collections, and again
                                                    contain the information claimed as CBI                  these product performance testing                      invites comment on this renewal.
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    must be submitted for inclusion in the                  guidelines for antimicrobial agents in                 DATES: Comments must be submitted on
                                                    public docket. Information so marked                    the Federal Register of March 16, 2012                 or before July 17, 2015.
                                                    will not be disclosed except in                         (77 FR 15750) (FRL–9332–4). Since                      ADDRESSES: Interested parties are
                                                    accordance with procedures set forth in                 then, the Agency has received                          invited to submit written comments to
                                                    40 CFR part 2.                                          information from the users that these                  the FDIC by any of the following
                                                       2. Tips for preparing your comments.                 test guidelines are confusing and in                   methods:
                                                    When preparing and submitting your                      some cases, inaccurate. The test                         • http://www.fdic.gov/regulations/
                                                    comments, see the commenting tips at                    guidelines have been re-formatted to be                laws/federal/.


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Document Created: 2015-12-15 14:23:12
Document Modified: 2015-12-15 14:23:12
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.
DatesComments must be received on or before August 17, 2015.
ContactFor general information contact: Melissa Chun, Regulatory Coordination Staff (7101M), Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
FR Citation80 FR 34638 

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