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 Range		34638-34639
FR Document		2015-14955

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.

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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: [email protected].
    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: [email protected].

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]
BILLING CODE 6560-50-P

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

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments must be received on or before August 17, 2015.
Contact		For 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 Citation		80 FR 34638