83_FR_8706 83 FR 8666 - Final Test Guidelines; Series 810-Product Performance Test Guidelines; Notice of Availability

83 FR 8666 - Final Test Guidelines; Series 810-Product Performance Test Guidelines; Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 40 (February 28, 2018)

Page Range8666-8667
FR Document2018-04106

EPA is announcing the availability of the following 810 Series final test guidelines: General Considerations for Testing Public Health Antimicrobial Pesticides--Guidance for Efficacy Testing, OCSPP Test Guideline 810.2000; Sterilants, Sporicides, and Decontaminants-- Guidance for Efficacy Testing, OCSPP Test Guideline 810.2100; and Disinfectants for Use on Environmental Surfaces--Guidance for Efficacy Testing, OCSPP Test Guideline 810.2200. These test guidelines are 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 for testing that is intended to provide data to inform regulatory decisions. The test guidelines provide guidance for conducting the tests, and are also used by EPA, the public, and companies that are subject to data submission requirements under one or more statutes.

Federal Register, Volume 83 Issue 40 (Wednesday, February 28, 2018) 
[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)]
[Notices]
[Pages 8666-8667]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04106]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0276; FRL-9971-08]


Final Test Guidelines; Series 810--Product Performance Test 
Guidelines; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of the following 810 Series 
final test guidelines: General Considerations for Testing Public Health 
Antimicrobial Pesticides--Guidance for Efficacy Testing, OCSPP Test 
Guideline 810.2000; Sterilants, Sporicides, and Decontaminants--
Guidance for Efficacy Testing, OCSPP Test Guideline 810.2100; and 
Disinfectants for Use on Environmental Surfaces--Guidance for Efficacy 
Testing, OCSPP Test Guideline

[[Page 8667]]

810.2200. These test guidelines are 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 for testing that is intended to provide data to inform 
regulatory decisions. The test guidelines provide guidance for 
conducting the tests, and are also used by EPA, the public, and 
companies that are subject to data submission requirements under one or 
more statutes.

FOR FURTHER INFORMATION CONTACT: Thao Pham, Antimicrobials Division 
(7510P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: 703-308-0125; email 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA is announcing the availability of three final test guidelines: 
General Considerations for Testing Public Health Antimicrobial 
Pesticides--Guidance for Efficacy Testing, OCSPP Test Guideline 
810.2000; Sterilants, Sporicides, and Decontaminants--Guidance for 
Efficacy Testing, OCSPP Test Guideline 810.2100; and Disinfectants for 
Use on Environmental Surfaces--Guidance for Efficacy Testing, OCSPP 
Test Guideline 810.2200.
    These final test guidelines are 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 (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 for testing that is 
intended to provide data to inform regulatory decisions under TSCA, 
FIFRA, and/or FFDCA.
    The test guidelines provide guidance for conducting tests, 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 particular 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-2015-0276, 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 final test guidelines under 
Series 810, entitled ``Product Performance Test Guidelines'' and 
identified as OCSPP Test Guidelines 810.2000, 810.2100, and 810.2200. 
The OCSPP 810 Test Guideline Series addresses antimicrobial pesticide 
products with public health uses or that bear public health claims for 
which product performance (efficacy) test data are required to be 
submitted to the Agency to support registration or amended 
registration, including, but not limited to the requirements of 40 CFR 
158.2220(a)(2). These guidelines provide an update to the 2012 OCSPP 
Guidelines 810.2000, 810.2100, and 810.2200 and supersede previous 
efficacy testing guidance for sterilants, sporicides, decontaminants, 
and disinfectant products.
    All studies initiated one year after the final publication date 
should utilize the revised guidelines for testing.

B. How was this final test guideline developed?

    The updated test guidelines integrate agency policies and revised 
test methods that have been released after the 2012 publication of the 
810 guideline series. The availability of public draft test guidelines 
for public comment was announced in a June 17, 2015 Federal Register 
notice (80 FR 34638) (FRL-9927-37). The public draft test guidelines 
were placed in the EPA Docket for public access. These final test 
guidelines were reformatted for ease of navigation and reading and 
incorporate changes resulting from the public comments received in 
response to the 2015 public draft test guidelines. The Agency is also 
making available in the docket a Response to Comments document that 
summarizes changes to the 2015 draft guidelines and addresses issues 
raised in the public comment submissions.

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

    Dated: February 6, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical 
Safety and Pollution Prevention.
[FR Doc. 2018-04106 Filed 2-27-18; 8:45 am]
BILLING CODE 6560-50-P

8666 Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices the petitions. The Order explains EPA’s Business Information (CBI) or other Respondents/affected entities: The basis for denying the petitions. information whose disclosure is respondents are related to the following Dated: February 8, 2018. restricted by statute. major group Standard Industrialization Onis ‘‘Trey’’ Glenn, III, FOR FURTHER INFORMATION CONTACT: Classification (SIC) codes: 5172– James W. Caldwell, Environmental Petroleum Products and 2911– Regional Administrator, Region 4. Engineer, Compliance Division, Office Petroleum Refining. The respondents [FR Doc. 2018–04093 Filed 2–27–18; 8:45 am] of Transportation and Air Quality, Mail are related to the following major group BILLING CODE 6560–50–P NAICS codes: 324110–Petroleum Code 6405A, U.S. Environmental Protection Agency, 1200 Pennsylvania Refineries; 324199–All Other Petroleum Avenue NW, Washington, DC 20460; and Coal Products Manufacturing; ENVIRONMENTAL PROTECTION Telephone: (202) 343–9303; Fax: (202) 325110–Petrochemical Manufacturing; AGENCY 343–2802; Email address: caldwell.jim@ 325199–All Other Basic Organic [EPA–HQ–OAR–2007–0595; FRL–9974–36– epa.gov. Chemical Manufacturing; 424710– OEI] Petroleum Bulk Stations and Terminals; SUPPLEMENTARY INFORMATION: and 424720–Petroleum and Petroleum Proposed Information Collection Supporting documents, which explain Products Merchant Wholesalers (except Request; Comment Request; in detail the information that the EPA Bulk Stations and Terminals). Regulation of Fuels and Fuel will be collecting, are available in the Respondent’s obligation to respond: Additives: Detergent Gasoline public docket for this ICR. The docket Mandatory per 40 CFR 80, Subpart G. AGENCY: Environmental Protection can be viewed online at https:// Estimated number of respondents: Agency (EPA). www.regulations.gov or in person at the 1,354 (total). EPA Docket Center, WJC West, Room Frequency of response: On occasion. ACTION: Notice. 3334, 1301 Constitution Ave. NW, Total estimated burden: 220,181 SUMMARY: The Environmental Protection Washington, DC. The telephone number hours (per year). Burden is defined at 5 Agency (EPA) has submitted an for the Docket Center is 202–566–1744. CFR 1320.03(b). information collection request (ICR), For additional information about EPA’s Total estimated cost: $16,554,566.00 Regulation of Fuels and Fuel Additives: public docket, visit http://www.epa.gov/ (per year), which includes $335,040.00 Detergent Gasoline (EPA ICR No. dockets. annualized capital or operation & 1655.10, OMB Control No. 2060–0275), Abstract: Gasoline combustion results maintenance costs. to the Office of Management and Budget in the formation of engine deposits. The Changes in Estimates: There is no (OMB) for review and approval in accumulation of deposits, particularly increase of hours in the total estimated accordance with the Paperwork in the orifices of fuel injectors and on respondent burden compared with the Reduction Act. This is a proposed intake valves, typically results in ICR currently approved by OMB. The reinstatement of the ICR, which was increased emissions and reduced engine respondent universe and responses also approved through November 30, 2017. performance. As fuel injectors replaced remain the same in this collection. Public comments were previously carburetors in the 1980’s, a number of There is a decrease in cost to the requested via the Federal Register on vehicle manufacturers experienced industry of $2,281,002 per year due to October 6, 2017 during a 60-day problems with deposit formation. a correction in industry labor costs. comment period. This notice allows for Detergent additives, which had been Courtney Kerwin, an additional 30 days for public available for years to control deposits in Director, Regulatory Support Division. comments. A fuller description of the carbureted vehicles, were improved to [FR Doc. 2018–04056 Filed 2–27–18; 8:45 am] ICR is given below, including its accommodate the new technology. BILLING CODE 6560–50–P estimated burden and cost to the public. However, their use was voluntary and An agency may not conduct or sponsor there were no regulatory standards by and a person is not required to respond which to gauge their effectiveness. ENVIRONMENTAL PROTECTION to a collection of information unless it Congress recognized the importance of AGENCY displays a currently valid OMB control effective detergent additives in number. minimizing vehicle emissions, and [EPA–HQ–OPP–2015–0276; FRL–9971–08] DATES: Comments must be submitted on added Section 211(1) in the Clean Air or before March 30, 2018. Act Amendments of 1990. It required Final Test Guidelines; Series 810— gasoline to contain detergent additives, Product Performance Test Guidelines; ADDRESSES: Submit your comments, effective January 1, 1995, and provided Notice of Availability referencing Docket ID No. EPA–HQ– OAR–2007–0595, online using https:// EPA with the authority to establish AGENCY: Environmental Protection www.regulations.gov (our preferred specifications for such additives. The Agency (EPA). method), by email to a-and-r-docket@ regulations at 40 CFR 80, Subpart G ACTION: Notice. epa.gov, or by mail to: (1) EPA Docket implemented certification requirements Center, Environmental Protection for detergents and imposed a variety of SUMMARY: EPA is announcing the Agency, Mail Code 28221T, 1200 recordkeeping and reporting availability of the following 810 Series Pennsylvania Ave. NW, Washington, DC requirements for certain parties final test guidelines: General 20460, and (2) OMB via email to oria_ involved with detergents, gasoline, or Considerations for Testing Public Health post-refinery component (any gasoline Antimicrobial Pesticides—Guidance for sradovich on DSK3GMQ082PROD with NOTICES submission@omb.eop.gov. Address comments to OMB Desk Officer for EPA. blending stock or any oxygenate that is Efficacy Testing, OCSPP Test Guideline EPA’s policy is that all comments blended with gasoline subsequent to the 810.2000; Sterilants, Sporicides, and received will be included in the public gasoline refining process (PRC)). All Decontaminants—Guidance for Efficacy docket without change including any gasolines must contain certified Testing, OCSPP Test Guideline personal information provided, unless detergents, with the exception of 810.2100; and Disinfectants for Use on the comment includes profanity, threats, research, racing, and aviation gasolines. Environmental Surfaces—Guidance for information claimed to be Confidential Form Numbers: None Efficacy Testing, OCSPP Test Guideline VerDate Sep<11>2014 17:25 Feb 27, 2018 Jkt 244001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\28FEN1.SGM 28FEN1

Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices 8667 810.2200. These test guidelines are part ‘‘should’’ with regard to an action Test Guidelines 810.2000, 810.2100, and of a series of test guidelines established means that the action is recommended 810.2200. The OCSPP 810 Test by the Office of Chemical Safety and rather than mandatory. The procedures Guideline Series addresses Pollution Prevention (OCSPP) for use in contained in the test guidelines are antimicrobial pesticide products with testing pesticides and chemical recommended for generating the data public health uses or that bear public substances. The test guidelines serve as that are the subject of the particular test health claims for which product a compendium of accepted scientific guideline, but EPA recognizes that performance (efficacy) test data are methodologies and protocols for testing departures may be appropriate in required to be submitted to the Agency that is intended to provide data to specific situations. You may propose to support registration or amended inform regulatory decisions. The test alternatives to the recommendations registration, including, but not limited guidelines provide guidance for described in the test guidelines, and the to the requirements of 40 CFR conducting the tests, and are also used Agency will assess them for 158.2220(a)(2). These guidelines by EPA, the public, and companies that appropriateness on a case-by-case basis. provide an update to the 2012 OCSPP are subject to data submission II. General Information Guidelines 810.2000, 810.2100, and requirements under one or more statutes. A. Does this action apply to me? 810.2200 and supersede previous efficacy testing guidance for sterilants, FOR FURTHER INFORMATION CONTACT: This action is directed to the public sporicides, decontaminants, and Thao Pham, Antimicrobials Division in general. Although this action may be disinfectant products. (7510P), Environmental Protection of particular interest to those persons Agency, 1200 Pennsylvania Ave. NW, who are or may be required to conduct All studies initiated one year after the Washington, DC 20460–0001; telephone testing of pesticides and chemical final publication date should utilize the number: 703–308–0125; email address: substances for submission to EPA under revised guidelines for testing. pham.thao@epa.gov. TSCA, FIFRA, and/or FFDCA, the B. How was this final test guideline SUPPLEMENTARY INFORMATION: Agency has not attempted to describe all developed? the specific entities that may be affected I. Introduction by this action. The updated test guidelines integrate EPA is announcing the availability of B. How can I get copies of this document agency policies and revised test three final test guidelines: General and other related information? methods that have been released after Considerations for Testing Public Health the 2012 publication of the 810 Antimicrobial Pesticides—Guidance for 1. Docket for this document. The docket for this action, identified by guideline series. The availability of Efficacy Testing, OCSPP Test Guideline public draft test guidelines for public 810.2000; Sterilants, Sporicides, and docket identification (ID) number EPA– HQ–OPP–2015–0276, is available at comment was announced in a June 17, Decontaminants—Guidance for Efficacy 2015 Federal Register notice (80 FR Testing, OCSPP Test Guideline http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 34638) (FRL–9927–37). The public draft 810.2100; and Disinfectants for Use on Public Docket (OPP Docket) in the test guidelines were placed in the EPA Environmental Surfaces—Guidance for Environmental Protection Agency Docket for public access. These final test Efficacy Testing, OCSPP Test Guideline Docket Center (EPA/DC), West William guidelines were reformatted for ease of 810.2200. These final test guidelines are part of Jefferson Clinton Bldg., Rm. 3334, 1301 navigation and reading and incorporate a series of test guidelines established by Constitution Ave. NW, Washington, DC changes resulting from the public OCSPP for use in testing pesticides and 20460–0001. The Public Reading Room comments received in response to the chemical substances to develop data for is open from 8:30 a.m. to 4:30 p.m., 2015 public draft test guidelines. The submission to the Agency under the Monday through Friday, excluding legal Agency is also making available in the Federal Food, Drug and Cosmetic holidays. The telephone number for the docket a Response to Comments (FFDCA) section 408 (21 U.S.C. 346a), Public Reading Room is (202) 566–1744, document that summarizes changes to the Federal Insecticide, Fungicide and and the telephone number for the OPP the 2015 draft guidelines and addresses Rodenticide Act (FIFRA) (7 U.S.C. 136 Docket is (703) 305–5805. Please review issues raised in the public comment et seq.), and the Toxic Substances the visitor instructions and additional submissions. Control Act (TSCA) (15 U.S.C. 2601 et information about the docket available at http://www.epa.gov/dockets. Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. seq.). The test guidelines serve as a 2601 et seq.; 21 U.S.C. 301 et seq. compendium of accepted scientific 2. Electronic access to the OCSPP test methodologies and protocols for testing guidelines. To access OCSPP test Dated: February 6, 2018. that is intended to provide data to guidelines electronically, please go to Charlotte Bertrand, inform regulatory decisions under http://www.epa.gov/ocspp/pubs/frs/ Acting Principal Deputy Assistant TSCA, FIFRA, and/or FFDCA. home/testmeth.htm. You may also Administrator, Office of Chemical Safety and The test guidelines provide guidance access the test guidelines in http:// Pollution Prevention. for conducting tests, and are also used www.regulations.gov, grouped by series [FR Doc. 2018–04106 Filed 2–27–18; 8:45 am] by EPA, the public, and companies that under docket ID numbers: EPA–HQ– BILLING CODE 6560–50–P are subject to data submission OPPT–2009–0150 through EPA–HQ– requirements under TSCA, FIFRA, and/ OPPT–2009–0159 and EPA–HQ–OPPT– or FFDCA. As guidance documents, the 2009–0576. sradovich on DSK3GMQ082PROD with NOTICES test guidelines are not binding on either III. Overview EPA or any outside parties, and EPA may depart from the test guidelines A. What action is EPA taking? where circumstances warrant and EPA is announcing the availability of without prior notice. At places in this final test guidelines under Series 810, guidance, the Agency uses the word entitled ‘‘Product Performance Test ‘‘should.’’ In this guidance, use of Guidelines’’ and identified as OCSPP VerDate Sep<11>2014 17:25 Feb 27, 2018 Jkt 244001 PO 00000 Frm 00019 Fmt 4703 Sfmt 9990 E:\FR\FM\28FEN1.SGM 28FEN1


Document Created: 2018-02-28 03:19:52
Document Modified: 2018-02-28 03:19:52
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.
ContactThao Pham, Antimicrobials Division (7510P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 703-308-0125; email
FR Citation83 FR 8666 
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