Draft Harmonized Test Guidelines; Notice of Availability and Request for Comments, 57031-57033 [2011-23666]

Download as PDF Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices Commission’s eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission’s Public Reference Room in Washington, DC. There is an eSubscription link on the web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail FERCOnlineSupport@ferc.gov or call (866) 208–3676 (toll free). For TTY, call (202) 502–8659. Dated: September 8, 2011. Kimberly D. Bose, Secretary. [FR Doc. 2011–23640 Filed 9–14–11; 8:45 am] BILLING CODE 6717–01–P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP11–540–000] wreier-aviles on DSKGBLS3C1PROD with NOTICES Dominion Transmission, Inc.; Notice of Request Under Blanket Authorization Take notice that on August 26, 2011, Dominion Transmission, Inc. (Dominion), 701 East Cary Street, Richmond, Virginia 23219, filed in Docket No. CP11–540–000, a prior notice request pursuant to sections 157.205 and 157.208 of the Commission’s regulations under the Natural Gas Act (NGA). Dominion seeks authorization to construct, install, own, and operate certain pipeline facilities in Marshall County, West Virginia. Dominion proposes to perform these activities under its blanket certificate originally issued in Docket No. CP82– 537–000 [21 FERC ¶ 62,172 (1982)], all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may be viewed on the Web at https://www.ferc.gov using the ‘‘eLibrary’’ link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at FERCOnlineSupport@ferc.gov or call toll-free, (886) 208–3676 or TYY, (202) 502–8659. Any questions regarding this application should be directed to Brad Knisley, Regulatory and Certificates Analyst, Dominion Transmission, Inc., 701 East Cary Street, Richmond, Virginia 23219, or by calling (804) 771– 4122 (telephone) or (804) 771–4804 (fax), Brad.A.Knisley@dom.com. Any person or the Commission’s Staff may, within 60 days after the issuance VerDate Mar<15>2010 15:07 Sep 14, 2011 Jkt 223001 of the instant notice by the Commission, file pursuant to Rule 214 of the Commission’s Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission’s Regulations under the NGA (18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA. The Commission strongly encourages electronic filings of comments, protests, and interventions via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission’s Web site (https:// www.ferc.gov) under the ‘‘e-Filing’’ link. Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Dated: September 8, 2011. Kimberly D. Bose, Secretary. [FR Doc. 2011–23638 Filed 9–14–11; 8:45 am] BILLING CODE 6717–01–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2009–0681; FRL–8879–1] Draft Harmonized Test Guidelines; Notice of Availability and Request for Comments Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: EPA is announcing the availability of the draft test guidelines for Series 810—Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents, concerning specifically air, textiles, and water. DATES: Comments must be received on or before December 14, 2011. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2009–0681, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), SUMMARY: PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 57031 Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2009– 0681. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at https:// www.regulations.gov, or, if only E:\FR\FM\15SEN1.SGM 15SEN1 57032 Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. Electronic access to the harmonized test guidelines. To access the harmonized test guidelines electronically, please go to https:// www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ You may also access the harmonized test guidelines in https://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. FOR FURTHER INFORMATION CONTACT: For technical information contact: Michele Wingfield, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–6349; e-mail address: wingfield.michele@epa.gov. For general information contact: The TSCA–Hotline, ABVI–Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; e-mail address: TSCA– Hotline@epa.gov. FIFRA information contact: Communications Services Branch (7506P), Field and External Affairs Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone numbers: (703) 305–5017 and TDD: (202) 554– 0551; fax number: (703) 305–5558. SUPPLEMENTARY INFORMATION: wreier-aviles on DSKGBLS3C1PROD with NOTICES 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 chemical substances under TSCA, FFDCA, or FIFRA, 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 e-mail. Clearly mark VerDate Mar<15>2010 15:07 Sep 14, 2011 Jkt 223001 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 submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at the estimate. vi. Provide specific examples to illustrate your concerns and suggested alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. What action is EPA taking? EPA is announcing the availability of the draft test guidelines for Series 810— Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents: 1. Disinfectants and Sanitizers for Use on Fabrics and Textiles—Efficacy Data Recommendations (OCSPP Guideline 810.2400). 2. Air Sanitizers—Efficacy Data Recommendations (OCSPP Guideline 810.2500). 3. Disinfectants for Use in Water— Efficacy Data Recommendations (OCSPP Guideline 810.2600). These draft test guidelines address efficacy testing for antimicrobial agents intended to be used on hard, inanimate, environmental surfaces; in the air; and in water, and which bear label claims as PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 disinfectants and/or sanitizers. Data from these studies are used to support the labeling claims for public health related antimicrobial agents. As a guidance document, the test guidelines are not binding on either EPA or any outside parties. 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. EPA will consider alternatives to the recommendations described in the test guidelines on a case-by-case basis, after assessing whether the alternative will provide the data necessary to inform the regulatory decision that must be made. III. How were these draft test guidelines developed? The product performance guidelines for antimicrobial agents were last updated in 1982 under the ‘‘Pesticide Assessment Guidelines—Subdivision G, Product Performance.’’ Since then, the Agency has presented several issues at two separate meetings of the FIFRA SAP related to the conduct of studies for antimicrobial agents (the first meeting September 9–10, 1997, announced in the Federal Register issue of July 14, 1997 (62 FR 37584) (FRL–5731–4) and the second meeting July 17–19, 2007, announced in the Federal Register issue of March 14, 2007 (72 FR 11867) (FRL– 8118–7)). Information and recommendations regarding these two SAPs can be found at the Office of Science and Coordination’s Web site: https://www.epa.gov/scipoly/sap/ index.htm. In addition to formatting changes to incorporate the guidelines into the OCSPP test guideline 810 series, EPA has added sections that incorporate new guidelines and clarifications from other guidance documents, and comments from the regulated industry. In particular, the waiver for the submission of efficacy data for air sanitizers that contain at least 5% glycol has been rescinded. Altogether, these draft test guidelines, once final, will represent the Agency’s current recommendations for conducting studies to support antimicrobial pesticide label claims. On October 8, 2008, EPA published in the Federal Register a proposed rule entitled ‘‘Data Requirements for Antimicrobial Pesticides’’ (73 FR 59382). Proposed 40 CFR 158.2220 contains a table entitled ‘‘Antimicrobial Product Performance Data E:\FR\FM\15SEN1.SGM 15SEN1 Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices wreier-aviles on DSKGBLS3C1PROD with NOTICES Requirements,’’ which referenced under the ‘‘Guideline Number’’ column the 91 series of test guidelines. EPA’s intention is to replace the 91 series test guideline designations with the appropriate 810 series test guideline designations. Therefore, at the time of the publication of the final rule, appropriate references to the 810 series test guideline numbers and names will be incorporated into the final rule. IV. Are there any applicable voluntary consensus standards that EPA should consider? This notice of availability does not involve a proposed regulatory action that would require the Agency to consider voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104– 113, section 12(d) (15 U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA requires EPA to provide an explanation to Congress, through OMB, when the Agency decides not to use available and applicable voluntary consensus standards when NTTAA directs the Agency to do so. These test guidelines represent an Agency effort to harmonize the test guidelines within OCSPP, as well as to harmonize the OCSPP test guidelines with those of OECD. The process for developing and amending these test guidelines, which began in 1991, includes public participation and the extensive involvement of the scientific community, including peer review by SAP and the SAB and other expert scientific organizations. In the future, these test guidelines could be incorporated into regulatory actions taken by EPA under TSCA, i.e., with regard to the TSCA section 4 testing program. Although, NTTAA requirements do not specifically apply to the issuance of these particular test guidelines, EPA invites your comment on whether or not there are any voluntary consensus standards that should be considered during the development of the final test guidelines or any future regulatory action that may be taken under TSCA. Future regulatory actions under TSCA section 4 may involve notice and comment rulemaking or negotiated voluntary testing enforcement consent agreements/orders/ VerDate Mar<15>2010 15:07 Sep 14, 2011 Jkt 223001 decrees. Nevertheless, However, the Agency is interested in whether or not there are any voluntary consensus standards that EPA should consider either as part of the development of the final test guidelines themselves or in lieu of these final test guidelines when the Agency develops any future regulatory action that incorporates these test guidelines. Any comments provided will assist the Agency in complying with NTTAA by facilitating the Agency’s identification of voluntary consensus standards that should be addressed in the test guideline or considered during the development of a proposed regulatory action that incorporates any standards included in the final test guidelines. Please submit your comments as directed under ADDRESSES. List of Subjects Environmental protection, Antimicrobial agents, Chemicals, Harmonized test guidelines, Health and safety. Dated: September 7, 2011. Stephen A. Owens, Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2011–23666 Filed 9–14–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9465–2; Docket ID No. EPA–HQ–ORD– 2011–0671] Draft Toxicological Review of nButanol: In Support of Summary Information on the Integrated Risk Information System (IRIS) Environmental Protection Agency (EPA). ACTION: Notice of Public Comment Period and Listening Session; Extension. AGENCY: EPA announced a 60-day public comment period and a listening session on August 31, 2011 (76 FR 54227) for the external review draft human health assessment titled, ‘‘Toxicological Review of n-Butanol: In Support of Summary Information on the Integrated Risk Information System (IRIS)’’ (EPA/635/R–11/081A). EPA is extending the public comment period one week because of a one-week delay in the release of the Toxicological Review to the public. The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA is releasing this draft SUMMARY: PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 57033 assessment solely for the purpose of predissemination peer review under applicable information quality guidelines. This draft assessment has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. After public review and comment, an EPA contractor will convene an expert panel for independent external peer review of this draft assessment. The public comment period and external peer review meeting are separate processes that provide opportunities for all interested parties to comment on the assessment. The external peer review meeting will be scheduled at a later date and announced in the Federal Register. Public comments submitted during the public comment period will be provided to the external peer reviewers before the panel meeting and considered by EPA in the disposition of public comments. Public comments received after the public comment period closes will not be submitted to the external peer reviewers and will only be considered by EPA if time permits. The listening session will be held on October 26, 2011, during the public comment period for this draft assessment. The purpose of the listening session is to allow all interested parties to present scientific and technical comments on draft IRIS health assessments to EPA and other interested parties attending the listening session. DATES: The public comment period will be extended to end November 7, 2011. Comments should be in writing and must be received by EPA by November 7, 2011. The listening session on the draft assessment for n-Butanol will be held on October 26, 2011, beginning at 9 a.m. and ending at 4 p.m., Eastern Daylight Time or when the last presentation has been completed. To attend the listening session, interested parties should register no later than October 19, 2011, following the instructions in the August 31 Federal Register Notice (76 FR 54227). The location and instructions for entering the building can be found in the August 31, 2011, Federal Register Notice (76 FR 54227). ADDRESSES: The draft ‘‘Toxicological Review of n-Butanol: In Support of Summary Information on the Integrated Risk Information System (IRIS)’’ is available primarily via the Internet on the NCEA home page under the Recent Additions and Publications menus at https://www.epa.gov/ncea. A limited number of paper copies are available from the Information Management Team (Address: Information Management E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57031-57033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23666]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0681; FRL-8879-1]


Draft Harmonized Test Guidelines; Notice of Availability and 
Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is announcing the availability of the draft test 
guidelines for Series 810--Product Performance Test Guidelines for 
Public Health Uses of Antimicrobial Agents, concerning specifically 
air, textiles, and water.

DATES: Comments must be received on or before December 14, 2011.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2009-0681, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0681. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at https://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at https://www.regulations.gov, or, if only

[[Page 57032]]

available in hard copy, at the OPP Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 
VA. The hours of operation of this Docket Facility are from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.
    Electronic access to the harmonized test guidelines. To access the 
harmonized test guidelines electronically, please go to https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' You may 
also access the harmonized test guidelines in https://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.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Michele Wingfield, Antimicrobials Division (7510P), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-6349; e-mail 
address: wingfield.michele@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.
    FIFRA information contact: Communications Services Branch (7506P), 
Field and External Affairs Division, Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone numbers: (703) 305-5017 and TDD: 
(202) 554-0551; fax number: (703) 305-5558.

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 chemical substances under TSCA, FFDCA, 
or FIFRA, 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 e-mail. 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 submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at the estimate.
    vi. Provide specific examples to illustrate your concerns and 
suggested alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. What action is EPA taking?

    EPA is announcing the availability of the draft test guidelines for 
Series 810--Product Performance Test Guidelines for Public Health Uses 
of Antimicrobial Agents:
    1. Disinfectants and Sanitizers for Use on Fabrics and Textiles--
Efficacy Data Recommendations (OCSPP Guideline 810.2400).
    2. Air Sanitizers--Efficacy Data Recommendations (OCSPP Guideline 
810.2500).
    3. Disinfectants for Use in Water--Efficacy Data Recommendations 
(OCSPP Guideline 810.2600).
    These draft test guidelines address efficacy testing for 
antimicrobial agents intended to be used on hard, inanimate, 
environmental surfaces; in the air; and in water, and which bear label 
claims as disinfectants and/or sanitizers. Data from these studies are 
used to support the labeling claims for public health related 
antimicrobial agents.
    As a guidance document, the test guidelines are not binding on 
either EPA or any outside parties. 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. EPA will consider alternatives to the 
recommendations described in the test guidelines on a case-by-case 
basis, after assessing whether the alternative will provide the data 
necessary to inform the regulatory decision that must be made.

III. How were these draft test guidelines developed?

    The product performance guidelines for antimicrobial agents were 
last updated in 1982 under the ``Pesticide Assessment Guidelines--
Subdivision G, Product Performance.'' Since then, the Agency has 
presented several issues at two separate meetings of the FIFRA SAP 
related to the conduct of studies for antimicrobial agents (the first 
meeting September 9-10, 1997, announced in the Federal Register issue 
of July 14, 1997 (62 FR 37584) (FRL-5731-4) and the second meeting July 
17-19, 2007, announced in the Federal Register issue of March 14, 2007 
(72 FR 11867) (FRL-8118-7)). Information and recommendations regarding 
these two SAPs can be found at the Office of Science and Coordination's 
Web site: https://www.epa.gov/scipoly/sap/index.htm. In addition to 
formatting changes to incorporate the guidelines into the OCSPP test 
guideline 810 series, EPA has added sections that incorporate new 
guidelines and clarifications from other guidance documents, and 
comments from the regulated industry. In particular, the waiver for the 
submission of efficacy data for air sanitizers that contain at least 5% 
glycol has been rescinded. Altogether, these draft test guidelines, 
once final, will represent the Agency's current recommendations for 
conducting studies to support antimicrobial pesticide label claims.
    On October 8, 2008, EPA published in the Federal Register a 
proposed rule entitled ``Data Requirements for Antimicrobial 
Pesticides'' (73 FR 59382). Proposed 40 CFR 158.2220 contains a table 
entitled ``Antimicrobial Product Performance Data

[[Page 57033]]

Requirements,'' which referenced under the ``Guideline Number'' column 
the 91 series of test guidelines. EPA's intention is to replace the 91 
series test guideline designations with the appropriate 810 series test 
guideline designations. Therefore, at the time of the publication of 
the final rule, appropriate references to the 810 series test guideline 
numbers and names will be incorporated into the final rule.

IV. Are there any applicable voluntary consensus standards that EPA 
should consider?

    This notice of availability does not involve a proposed regulatory 
action that would require the Agency to consider voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use 
voluntary consensus standards in its regulatory activities unless to do 
so would be inconsistent with applicable law or otherwise impractical. 
Voluntary consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, and business 
practices) that are developed or adopted by voluntary consensus 
standards bodies. NTTAA requires EPA to provide an explanation to 
Congress, through OMB, when the Agency decides not to use available and 
applicable voluntary consensus standards when NTTAA directs the Agency 
to do so.
    These test guidelines represent an Agency effort to harmonize the 
test guidelines within OCSPP, as well as to harmonize the OCSPP test 
guidelines with those of OECD. The process for developing and amending 
these test guidelines, which began in 1991, includes public 
participation and the extensive involvement of the scientific 
community, including peer review by SAP and the SAB and other expert 
scientific organizations.
    In the future, these test guidelines could be incorporated into 
regulatory actions taken by EPA under TSCA, i.e., with regard to the 
TSCA section 4 testing program. Although, NTTAA requirements do not 
specifically apply to the issuance of these particular test guidelines, 
EPA invites your comment on whether or not there are any voluntary 
consensus standards that should be considered during the development of 
the final test guidelines or any future regulatory action that may be 
taken under TSCA. Future regulatory actions under TSCA section 4 may 
involve notice and comment rulemaking or negotiated voluntary testing 
enforcement consent agreements/orders/decrees. Nevertheless, However, 
the Agency is interested in whether or not there are any voluntary 
consensus standards that EPA should consider either as part of the 
development of the final test guidelines themselves or in lieu of these 
final test guidelines when the Agency develops any future regulatory 
action that incorporates these test guidelines. Any comments provided 
will assist the Agency in complying with NTTAA by facilitating the 
Agency's identification of voluntary consensus standards that should be 
addressed in the test guideline or considered during the development of 
a proposed regulatory action that incorporates any standards included 
in the final test guidelines. Please submit your comments as directed 
under ADDRESSES.

List of Subjects

    Environmental protection, Antimicrobial agents, Chemicals, 
Harmonized test guidelines, Health and safety.

    Dated: September 7, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2011-23666 Filed 9-14-11; 8:45 am]
BILLING CODE 6560-50-P
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