80 FR 35349 - Agency Information Collection Activities; Proposed Renewal and Comment Request; TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 118 (June 19, 2015)

Page Range		35349-35350
FR Document		2015-14946

In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled: ``TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)'' and identified by EPA ICR No. 0586.13 and OMB Control No. 2070-0054, represents the renewal of an existing ICR that is scheduled to expire on March 31, 2016. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.

Federal Register, Volume 80 Issue 118 (Friday, June 19, 2015)

[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Pages 35349-35350]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14946]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0236; FRL-9928-94]


Agency Information Collection Activities; Proposed Renewal and 
Comment Request; TSCA Section 8(a) Preliminary Assessment Information 
Rule (PAIR)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this 
document announces that EPA is planning to submit an Information 
Collection Request (ICR) to the Office of Management and Budget (OMB). 
The ICR, entitled: ``TSCA Section 8(a) Preliminary Assessment 
Information Rule (PAIR)'' and identified by EPA ICR No. 0586.13 and OMB 
Control No. 2070-0054, represents the renewal of an existing ICR that 
is scheduled to expire on March 31, 2016. Before submitting the ICR to 
OMB for review and approval, EPA is soliciting comments on specific 
aspects of the proposed information collection that is summarized in 
this document. The ICR and accompanying material are available in the 
docket for public review and comment.

DATES: Comments must be received on or before August 18, 2015.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2015-0236, 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: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 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 technical information contact: 
Mike Mattheisen, Chemical Control Division (7405 M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-3077; email address: mattheisen.mike@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), 
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses. In particular, EPA is requesting comments from 
very small businesses (those that employ less than 25) on examples of 
specific additional efforts that EPA could make to reduce the paperwork 
burden for very small businesses affected by this collection.

II. What Information Collection Activity or ICR Does this Action Apply 
to?

    Title: TSCA Section 8(a) Preliminary Assessment Information Rule 
(PAIR).
    ICR number: EPA ICR No. 0586.13.
    OMB control number: OMB Control No. 2070-0054.
    ICR status: This ICR is currently scheduled to expire on March 31, 
2016. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information, unless it displays 
a currently valid OMB control number. The OMB control numbers for EPA's 
regulations in title 40 of the Code of Federal Regulations (CFR), after 
appearing in the Federal Register when approved, are listed in 40 CFR 
part 9, are displayed either by publication in the Federal Register or 
by other appropriate means, such as on the related collection 
instrument or form, if applicable. The display of OMB control numbers 
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: Section 8(a) of the Toxic Substances Control Act (TSCA) 
authorizes EPA to promulgate rules under which manufacturers, importers 
and processors of chemical substances and mixtures must maintain 
records and submit reports to EPA. EPA has promulgated the Preliminary 
Assessment Information Rule (PAIR) under TSCA section 8(a). EPA uses 
PAIR to collect information to identify, assess and manage human health 
and environmental risks from chemical substances, mixtures and 
categories. PAIR requires chemical manufacturers and importers to 
complete a standardized reporting form to help evaluate the potential 
for adverse human health and environmental effects caused by the 
manufacture or importation of identified chemical substances, mixtures 
or categories. Chemicals identified by EPA or any other federal agency, 
for which a justifiable information need for production, use or 
exposure-related data can be satisfied by the use of the PAIR are 
proper subjects for TSCA section 8(a) PAIR rulemaking. In most 
instances the information that EPA receives from a PAIR report is 
sufficient to satisfy the information need in question. This 
information collection addresses the reporting and recordkeeping 
requirements associated with TSCA section 8(a).
    Responses to the collection of information are mandatory (see 40 
CFR parts 712, 766, and 792). Respondents

[[Page 35350]]

may claim all or part of a response confidential. EPA will disclose 
information that is covered by a claim of confidentiality only to the 
extent permitted by, and in accordance with, the procedures in TSCA 
section 14 and 40 CFR part 2.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 31.5 
hours per response. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related 
materials, provides a detailed explanation of the collection activities 
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Entities potentially affected by 
this ICR are companies that manufacture, process or import chemical 
substances, mixtures or categories.
    Estimated total number of potential respondents: 1.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 31.5 hours.
    Estimated total annual costs: $2,388. This includes an estimated 
burden cost of $2,388 and an estimated cost of $0 for capital 
investment or maintenance and operational costs.

III. Are There Changes in the Estimates from the Last Approval?

    There is a decrease of 916 hours in the total estimated respondent 
burden compared with that identified in the ICR currently approved by 
OMB. This decrease reflects additional both adjustment changes from a 
reduction in the assumed number of PAIR reports filed annually, and 
program changes resulting from mandatory electronic submissions of PAIR 
reports. In recent years (FY 2011-FY 2014), EPA has received no PAIR 
submissions and, for the purposes of this analysis, EPA assumes an 
annual rate of one submission per year. At the time OMB last renewed 
this ICR, EPA estimated an average of 33 reports from 14.8 submitters 
based on fiscal year 2006-2010 data. The ICR supporting statement 
provides a detailed analysis of the change in burden estimate. This 
change is both an adjustment and a program change.

IV. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to 
announce the submission of the ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the technical person listed under 
FOR FURTHER INFORMATION CONTACT.

    Authority: 44 U.S.C. 3501 et seq.

    Dated: June 10, 2015.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2015-14946 Filed 6-18-15; 8:45 am]
 BILLING CODE 6560-50-P

Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices 35349

2. EPA Registration Numbers: 264–824 and information you consider to be could make to reduce the paperwork
264–825. Docket ID number: EPA–HQ–OPP– Confidential Business Information (CBI) burden for very small businesses
2015–0327. Applicant: Bayer CropScience or other information whose disclosure is affected by this collection.
LP, 2 T.W. Alexander Drive, P.O. Box 12014, restricted by statute.
RTP, NC 27709. Active ingredient: II. What Information Collection
• Mail: Document Control Office
Prothioconazole. Product type: Fungicide. Activity or ICR Does this Action Apply
Proposed Use: Sorghum seed treatment. (7407M), Office of Pollution Prevention
to?
Contact: RD. and Toxics (OPPT), Environmental
3. EPA File Symbol: 89825–R. Docket ID Protection Agency, 1200 Pennsylvania Title: TSCA Section 8(a) Preliminary
number: EPA–HQ–OPP–2015–0328. Ave. NW., Washington, DC 20460–0001. Assessment Information Rule (PAIR).
Applicant: Barnacle-Blocker, LLC., 12907 • Hand Delivery: To make special ICR number: EPA ICR No. 0586.13.
Yacht Club Place, Cortez, FL 34215. Active arrangements for hand delivery or OMB control number: OMB Control
ingredient: Capsaicin. Product type: delivery of boxed information, please No. 2070–0054.
Antifoulant. Proposed Use: Boats. Contact: follow the instructions at http:// ICR status: This ICR is currently
AD. scheduled to expire on March 31, 2016.
www.epa.gov/dockets/contacts.html.
Authority: 7 U.S.C. 136 et seq. Additional instructions on An Agency may not conduct or sponsor,
commenting or visiting the docket, and a person is not required to respond
Dated: June 3, 2015. to, a collection of information, unless it
Jennifer Mclain, along with more information about
displays a currently valid OMB control
Acting, Director, Antimicrobials Division, dockets generally, is available at
number. The OMB control numbers for
Office of Pesticide Programs. http://www.epa.gov/dockets.
EPA’s regulations in title 40 of the Code
[FR Doc. 2015–15180 Filed 6–18–15; 08:45 am] FOR FURTHER INFORMATION CONTACT: For of Federal Regulations (CFR), after
BILLING CODE 6560–50–P
technical information contact: Mike appearing in the Federal Register when
Mattheisen, Chemical Control Division approved, are listed in 40 CFR part 9,
(7405 M), Office of Pollution Prevention are displayed either by publication in
ENVIRONMENTAL PROTECTION and Toxics, Environmental Protection the Federal Register or by other
AGENCY Agency, 1200 Pennsylvania Ave. NW., appropriate means, such as on the
Washington, DC 20460–0001; telephone related collection instrument or form, if
[EPA–HQ–OPPT–2015–0236; FRL–9928–94]
number: (202) 564–3077; email address: applicable. The display of OMB control
Agency Information Collection mattheisen.mike@epa.gov. numbers for certain EPA regulations is
Activities; Proposed Renewal and For general information contact: The consolidated in 40 CFR part 9.
Comment Request; TSCA Section 8(a) TSCA-Hotline, ABVI-Goodwill, 422 Abstract: Section 8(a) of the Toxic
Preliminary Assessment Information South Clinton Ave., Rochester, NY Substances Control Act (TSCA)
Rule (PAIR) 14620; telephone number: (202) 554– authorizes EPA to promulgate rules
1404; email address: TSCA-Hotline@ under which manufacturers, importers
AGENCY: Environmental Protection epa.gov. and processors of chemical substances
Agency (EPA). SUPPLEMENTARY INFORMATION: and mixtures must maintain records and
ACTION: Notice. submit reports to EPA. EPA has
I. What Information is EPA Particularly promulgated the Preliminary
SUMMARY: In compliance with the Interested in? Assessment Information Rule (PAIR)
Paperwork Reduction Act (PRA), this Pursuant to PRA section 3506(c)(2)(A) under TSCA section 8(a). EPA uses
document announces that EPA is (44 U.S.C. 3506(c)(2)(A)), EPA PAIR to collect information to identify,
planning to submit an Information specifically solicits comments and assess and manage human health and
Collection Request (ICR) to the Office of information to enable it to: environmental risks from chemical
Management and Budget (OMB). The 1. Evaluate whether the proposed substances, mixtures and categories.
ICR, entitled: ‘‘TSCA Section 8(a) collection of information is necessary PAIR requires chemical manufacturers
Preliminary Assessment Information for the proper performance of the and importers to complete a
Rule (PAIR)’’ and identified by EPA ICR functions of the Agency, including standardized reporting form to help
No. 0586.13 and OMB Control No. whether the information will have evaluate the potential for adverse
2070–0054, represents the renewal of an practical utility. human health and environmental effects
existing ICR that is scheduled to expire 2. Evaluate the accuracy of the caused by the manufacture or
on March 31, 2016. Before submitting Agency’s estimates of the burden of the importation of identified chemical
the ICR to OMB for review and proposed collection of information, substances, mixtures or categories.
approval, EPA is soliciting comments on including the validity of the Chemicals identified by EPA or any
specific aspects of the proposed methodology and assumptions used. other federal agency, for which a
information collection that is 3. Enhance the quality, utility, and justifiable information need for
summarized in this document. The ICR clarity of the information to be production, use or exposure-related data
and accompanying material are collected. can be satisfied by the use of the PAIR
available in the docket for public review 4. Minimize the burden of the are proper subjects for TSCA section
and comment. collection of information on those who 8(a) PAIR rulemaking. In most instances
DATES: Comments must be received on are to respond, including through the the information that EPA receives from
or before August 18, 2015. use of appropriate automated electronic, a PAIR report is sufficient to satisfy the
asabaliauskas on DSK5VPTVN1PROD with NOTICES

ADDRESSES: Submit your comments, mechanical, or other technological information need in question. This
identified by docket identification (ID) collection techniques or other forms of information collection addresses the
number EPA–HQ–OPPT–2015–0236, by information technology, e.g., permitting reporting and recordkeeping
one of the following methods: electronic submission of responses. In requirements associated with TSCA
• Federal eRulemaking Portal: http:// particular, EPA is requesting comments section 8(a).
www.regulations.gov. Follow the online from very small businesses (those that Responses to the collection of
instructions for submitting comments. employ less than 25) on examples of information are mandatory (see 40 CFR
Do not submit electronically any specific additional efforts that EPA parts 712, 766, and 792). Respondents

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35350 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Notices

may claim all or part of a response and approval pursuant to 5 CFR efficient screening using alternative test
confidential. EPA will disclose 1320.12. EPA will issue another Federal methods to some assays in the Tier 1
information that is covered by a claim Register document pursuant to 5 CFR battery to protect human health and the
of confidentiality only to the extent 1320.5(a)(1)(iv) to announce the environment.
permitted by, and in accordance with, submission of the ICR to OMB and the DATES: Comments must be received on
the procedures in TSCA section 14 and opportunity to submit additional or before August 18, 2015.
40 CFR part 2. comments to OMB. If you have any ADDRESSES: Submit your comments,
Burden statement: The annual public questions about this ICR or the approval identified by docket identification (ID)
reporting and recordkeeping burden for process, please contact the technical number EPA–HQ–OPPT–2015–0305, by
this collection of information is person listed under FOR FURTHER one of the following methods:
estimated to average 31.5 hours per INFORMATION CONTACT. • Federal eRulemaking Portal: http://
response. Burden is defined in 5 CFR Authority: 44 U.S.C. 3501 et seq. www.regulations.gov. Follow the online
1320.3(b). instructions for submitting comments.
The ICR, which is available in the Dated: June 10, 2015.
Do not submit electronically any
docket along with other related James Jones, information you consider to be
materials, provides a detailed Assistant Administrator, Office of Chemical Confidential Business Information (CBI)
explanation of the collection activities Safety and Pollution Prevention. or other information whose disclosure is
and the burden estimate that is only [FR Doc. 2015–14946 Filed 6–18–15; 8:45 am] restricted by statute.
briefly summarized here: BILLING CODE 6560–50–P • Mail: Document Control Office
Respondents/Affected Entities: (7407M), Office of Pollution Prevention
Entities potentially affected by this ICR and Toxics (OPPT), Environmental
are companies that manufacture, ENVIRONMENTAL PROTECTION Protection Agency, 1200 Pennsylvania
process or import chemical substances, AGENCY Ave. NW., Washington, DC 20460–0001.
mixtures or categories. [EPA–HQ–OPPT–2015–0305; FRL–9928–69] • Hand Delivery: To make special
Estimated total number of potential arrangements for hand delivery or
respondents: 1. Use of High Throughput Assays and delivery of boxed information, please
Frequency of response: On occasion. Computational Tools; Endocrine follow the instructions at http://
Estimated total average number of Disruptor Screening Program; Notice www.epa.gov/dockets/contacts.html.
responses for each respondent: 1. of Availability and Opportunity for Additional instructions on
Estimated total annual burden hours: Comment commenting or visiting the docket,
31.5 hours. along with more information about
Estimated total annual costs: $2,388. AGENCY: Environmental Protection dockets generally, is available at http://
This includes an estimated burden cost Agency (EPA). www.epa.gov/dockets.
of $2,388 and an estimated cost of $0 for ACTION: Notice. FOR FURTHER INFORMATION CONTACT: For
capital investment or maintenance and technical information contact: Jane
operational costs. SUMMARY: This document describes how
EPA is planning to incorporate an Robbins, Office of Science Coordination
III. Are There Changes in the Estimates alternative scientific approach to screen and Policy (OSCP), Office of Chemical
from the Last Approval? chemicals for their ability to interact Safety and Pollution Prevention,
with the endocrine system. This will Environmental Protection Agency, 1200
There is a decrease of 916 hours in the
improve the Agency’s ability to fulfill its Pennsylvania Ave. NW., Washington,
total estimated respondent burden
statutory mandate to screen pesticide DC 20460–0001; telephone number:
compared with that identified in the ICR
chemicals and other substances for their (202) 564–6625; email address:
currently approved by OMB. This
ability to cause adverse effects by their robbins.jane@epa.gov.
decrease reflects additional both For general information contact: The
adjustment changes from a reduction in interaction with the endocrine system.
The approach incorporates validated TSCA-Hotline, ABVI-Goodwill, 422
the assumed number of PAIR reports South Clinton Ave., Rochester, NY
filed annually, and program changes high throughput assays and a
computational model and, based on 14620; telephone number: (202) 554–
resulting from mandatory electronic 1404; email address: TSCA-Hotline@
submissions of PAIR reports. In recent current research, can serve as an
alternative for some of the current epa.gov.
years (FY 2011–FY 2014), EPA has
received no PAIR submissions and, for assays in the Endocrine Disruptor SUPPLEMENTARY INFORMATION:
the purposes of this analysis, EPA Screening Program (EDSP) Tier 1 I. General Information
assumes an annual rate of one battery. EPA has partial screening
submission per year. At the time OMB results for over 1800 chemicals that A. Does this action apply to me?
last renewed this ICR, EPA estimated an have been evaluated using high This action is directed to the public
average of 33 reports from 14.8 throughput assays and a computational in general, and may be of interest to a
submitters based on fiscal year 2006– model for the estrogen receptor wide range of stakeholders including
2010 data. The ICR supporting pathway. In the future, EPA anticipates those interested in endocrine testing of
statement provides a detailed analysis of that additional alternative methods will chemicals (including pesticides), and
the change in burden estimate. This be available for EDSP chemical the EDSP in general. Since others also
screening based on further
asabaliauskas on DSK5VPTVN1PROD with NOTICES

change is both an adjustment and a may be interested, the Agency has not
program change. advancements of high throughput assays attempted to describe all the specific
and computational models for other entities that may be affected by this
IV. What is the Next Step in the Process endocrine pathways. Use of these action.
for this ICR? alternative methods will accelerate the
EPA will consider the comments pace of screening, decrease costs, and B. What is the agency authority for
received and amend the ICR as reduce animal testing. In addition, this taking this action?
appropriate. The final ICR package will approach advances the goal of providing The EDSP is established under section
then be submitted to OMB for review sensitive, specific, quantitative, and 408(p) of the Federal Food, Drug and

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Document Created: 2018-02-22 11:10:31
Document Modified: 2018-02-22 11:10:31

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 18, 2015.
Contact		For technical information contact: Mike Mattheisen, Chemical Control Division (7405 M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
FR Citation		80 FR 35349