[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Proposed Rules]
[Pages 53369-53371]
[FR Doc No: 2011-21936]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0617; FRL-9457-1]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Adhesives and Sealants Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve State Implementation Plan (SIP)
revision submitted by the Commonwealth of Pennsylvania. The SIP
revision pertains to amendments to 25 Pennsylvania Code (Pa. Code)
Chapters 121, 129, and 130, relating to control of emissions of
volatile organic compounds (VOC) from the manufacture, sale, use, or
application of adhesives, sealants, primers, and solvents. The revision
also amends related definitions. This action is being taken under the
Clean Air Act (CAA).

DATES: Written comments must be received on or before September 26,
2011.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2011-0617 by one of the following methods:
    A. http:[sol][sol]www.regulations.gov. Follow the on-line
instructions for submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2011-0617, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID Number EPA-R03-OAR-
2011-0617. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http:[sol][sol]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
http:[sol][sol]www.regulations.gov or e-mail. The
http:[sol][sol]www.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
http:[sol][sol]www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public 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 electronic docket are listed in the
http:[sol][sol]www.regulations.gov index. Although listed in the index,
some information is not publicly available, i.e., 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 electronically in
http:[sol][sol]www.regulations.gov or in hard copy during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650

Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Pennsylvania Department of Environmental
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On January 12, 2011, the Pennsylvania
Department of Environmental Protection (PADEP) submitted a revision to
the Pennsylvania SIP. The SIP revision consists of Pennsylvania's
amendments to 25 Pa. Code Chapters 121, 129, and 130 relating to
general provisions, standards for sources, and standards for products.
The amendments are part of Pennsylvania's strategy to achieve and
maintain the 8-hour ozone national ambient air quality standard (NAAQS)
throughout the Commonwealth.
    The SIP revision consists of the following amendments:

A. Amendments to 25 Pa. Code Chapter 121--General Provisions

    The amendments to section 121.1--Definitions, add definitions for
53 new terms, including those that relate to the adhesive, sealant,
primer, and solvent product categories regulated under section 129.77
and Chapter 130, Subchapter D and amends definitions for 9 existing
terms for clarity, style, and format or to explain new product
categories.

B. Amendments to 25 Pa. Code Chapter 129--Standards for Sources of VOCs

    The revision amends section 129.51(a)--Equivalency, in order to
include adhesives, sealants, primers, and solvents covered by section
129.77, entitled ``Control of emissions from the use or application of
adhesives, sealants, primers and solvents.'' Section 129.51(a) provides
an alternative method for owners and operators of facilities to achieve
compliance with air emission limits.
    The Ozone Transport Commission (OTC) states developed a model rule
``OTC Model Rule For Adhesives and Sealants'' dated 2006 which was
based on the 1998 California Air Resources Board (CARB) reasonably
available control technology (RACT) determination. This RACT
determination applied to both the manufacture and use of adhesives,
sealants, adhesive primers, or sealant primers, in both industrial and
manufacturing facilities and in the field. California Air Districts
used this determination to develop regulations for this category. EPA
addressed this source category with a Control Techniques Guideline
(CTG) document for Miscellaneous Industrial Adhesives dated September
2008. This CTG was developed in response to section 183(e) of the CAA
requirement for EPA to study and regulate consumer and commercial
products, which is included in EPA's Report to Congress, ``Study of
Volatile Organic Compound Emissions from Consumer and Commercial
Products--Comprehensive Emissions Inventory.''
    The miscellaneous industrial adhesives category was limited to
adhesives and adhesive primers used in industrial and manufacturing
operations and did not include products applied in the field.
Therefore, the OTC model rule and state efforts in developing
individual regulations preceded EPA's CTG for this source category and
were broader in applicability.
    The new section 129.77 adds regulations that: (a) Set standards for
the application of adhesives, sealants, adhesive primers, and sealant
primers by providing options for appliers either to use a product with
a VOC content equal to or less than a specified limit or to use add-on
controls; (b) establish that owners or operators may not use or apply
at the facility an adhesive, sealant, adhesive primer, sealant primer,
surface preparation, or cleanup solvent that exceeds the VOC content
limits; (c) specify requirements for owners or operators of a facility
that uses or applies a surface preparation solvent or cleanup solvent
or removes an adhesive, sealant, adhesive primer, and sealant primer
from the parts of spray application equipment; (d) provide for an
alternative add-on control system requirement of at least 85 percent
overall control efficiency (capture and destruction), by weight; (e)
specify requirements for proper storage and disposal, work practices,
surface preparation, and cleanup solvent composition; and (f) specify
exemptions, as well as registration and product labeling requirements,
recordkeeping requirements, and test methods and compliance procedures.

C. Amendments to 25 Pa. Code Chapter 130 Subchapter D--Adhesives,
Sealants, Primers, and Solvents General Provisions

    The new 25 Pa. Code Chapter 130 Subchapter D adds regulations that:
(a) Set emission standards and VOC content limits for the sale, supply,
offer for sale, manufacture, use, or application of adhesive, sealant,
adhesive primer, and sealant primer products; (b) set emission
standards and VOC content limits for the sale, supply, offer for sale,
manufacture, use, or application sealant products applied to certain
substrates, surface preparation solvents, and cleanup solvents; (c)
establish requirements for surface preparation solvent or cleanup
solvent, removal methods, and proper storage and disposal; (d)
establish that a person may not solicit the use of a product if
application would result in a violation of the applicable VOC content
limit; (e) specify exemptions for an adhesive, sealant, adhesive
primer, or sealant primer product; and (f) specify recordkeeping
requirements, test methods, registration, and product labeling
requirements and compliance procedures.
    A detailed summary of EPA's review of and rationale for proposing
to approve this SIP revision may be found in the Technical Support
Document (TSD) for this action which is available on-line at http://www.regulations.gov, Docket number EPA-R03-OAR-2011-0617.

III. Proposed Action

    EPA is proposing to approve the Pennsylvania SIP revision amending
section 121.1 ``Definitions'' and section 129.51(a) ``Equivalency'' of
25 Pa. Code Chapter 129. EPA is also proposing to approve the
Pennsylvania SIP revisions adding section 129.77 ``Control of emissions
from the use or application of adhesives, sealants, primers, and
solvents'' of 25 Pa. Code Chapter 129 and 25 Pa. Code Chapter 130
Subchapter D ``Adhesives, Sealants, Primers, and Solvents General
Provisions.'' EPA is soliciting public comments on the issues discussed
in this document. These comments will be considered before taking final
action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);

     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, pertaining to Pennsylvania's
control of VOCs from adhesives and sealants, does not have Tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on Tribal governments or preempt Tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Ozone, Reporting
and recordkeeping requirements, Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: August 11, 2011.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2011-21936 Filed 8-25-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Notices]
[Pages 66920-66922]
[FR Doc No: 2011-27953]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC11-549-001]

Commission Information Collection Activities (FERC-549); Comment
Request; Submitted for OMB Review

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice.

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SUMMARY: In compliance with the requirements of section 3507 of the
Paperwork Reduction Act of 1995, 44 U.S.C. 3507, the Federal Energy
Regulatory Commission (Commission or FERC) has submitted the
information collection described below to the Office of Management and
Budget (OMB) for review of the information collection requirements. Any
interested person may file comments directly with OMB and should
address a copy of those comments to the Commission as explained below.
The Commission issued a Notice in the Federal Register (76 FR 46783,
08/3/2011) requesting public comments. FERC received no comments on the
FERC-549 and has made this notation in its submission to OMB.

DATES: Comments on the collection of information are due by November
28, 2011.

ADDRESSES: Address comments on the collection of information to the
Office of Management and Budget, Office of Information and Regulatory
Affairs, Attention: Federal Energy Regulatory Commission Desk Officer.
Comments to OMB should be filed electronically, c/o<EMAIL_ADDRESS>and include OMB Control Number 1902-0086 for
reference. The Desk Officer may be reached by telephone at (202) 395-
4718.
    A copy of the comments should also be sent to the Federal Energy
Regulatory Commission and should refer to Docket No. IC11-549-001.
Comments may be filed either electronically or in paper format. Those
persons filing electronically do not need to make a paper filing.
Documents filed electronically via the Internet must be prepared in an
acceptable filing format and in compliance with the Federal Energy
Regulatory Commission submission guidelines. Complete filing
instructions and acceptable filing formats are available at http://www.ferc.gov/help/submission-guide.asp. To file the document
electronically, access the Commission's Web site and click on Documents
& Filing, E-Filing (http://www.ferc.gov/docs-filing/efiling.asp), and
then follow the instructions for each screen. First time users will
have to establish a user name and password. The Commission will send an
automatic acknowledgement to the sender's email address upon receipt of
comments.
    For paper filings, the comments should be submitted to the Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street, NE., Washington, DC 20426, and should refer to Docket No. IC11-
549-001.
    Users interested in receiving automatic notification of activity in
FERC Docket Number IC11-549 may do so through eSubscription at http://www.ferc.gov/docs-filing/esubscription.asp. All comments may be viewed,
printed or downloaded remotely via the Internet through FERC's homepage
using the ``eLibrary'' link. For user assistance, contact
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION: The information collected under the
requirements of FERC-549, ``Gas Pipeline Rates: NGPA Title III and NGA
Blanket Certificate Transactions'' (OMB Control No. 1902-0086), is used
by the Commission to implement the statutory provisions of sections 311
and 312 of the Natural Gas Policy Act (NGPA) and section 7 of the
Natural Gas Act (NGA). The Commission implements these statues in 18
CFR 284.

Semi-Annual Storage Report for Interstate Pipelines \1\
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    \1\ On September 15, 2011 the Commission issued a Notice of
Proposed Rulemaking in docket no. RM11-4 proposing to delete the
semi-annual storage report for interstate and intrastate pipelines.
OMB has reviewed the proposal and is withholding final approval
until the final rule. Because the FERC-549 collection (including the
semi-annual storage report for interstate pipelines) has an
expiration date of 12/31/2011 the Commission seeking for renewal of
the collection expecting that this collection will likely be
modified by a final rule at a later date.
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    18 CFR 284.13(e) requires each interstate pipeline to file with the
Commission a report of storage activity. The Commission adopted the
existing semi-annual storage reporting requirements for interstate
pipelines in their current form in 1992 as part of Order No. 636, and
there have been only minor modifications in the semi-annual storage
reporting requirements since that date.
    Natural gas production is relatively constant throughout the year,
while many uses of natural gas, residential space heating for example,
are seasonal. Natural gas storage plays a critical role in balancing
the seasonal demand with relatively constant supply, and the data
collected in the semi-annual storage report provides important
information about natural gas pipelines' ability to affect the prices
shippers can obtain from consumers.
    Improved storage technology and the increased use of natural gas in
industry and electric generation have helped transform the storage
market since 1992. There has been a sharp increase in demand for
natural gas outside of the traditional winter months. Withdrawals and
injections, instead of occurring on a uniform annual schedule based on
heating needs, now occur dynamically year-round in response to market
forces.

Transportation by Interstate Pipelines

    In 18 CFR 284.102(e) the Commission requires interstate pipelines
to obtain proper certification in order to ship natural gas on behalf
of intrastate pipelines and local distribution

companies (LDC). This certification consists of a letter from the
intrastate pipeline or LDC authorizing the intrastate pipeline to ship
gas on its behalf. In addition, interstate pipelines must obtain from
its shippers certifications including sufficient information to verify
that their services qualify under this section.

Rates and Charges for Intrastate Pipelines

    18 CFR 284.123(b) provides that intrastate gas pipeline companies
file for Commission approval of rates for services performed in the
interstate transportation of gas. An intrastate gas pipeline company
may elect to use rates contained in one of its then effective
transportation rate schedules on file with an appropriate state
regulatory agency for intrastate service comparable to the interstate
service OR file proposed rates and supporting information showing the
rates are cost based and are fair and equitable. 150 days after the
application is filed the rate is deemed to be fair and equitable unless
the Commission either extends the time for action, institutes a
proceeding or issues an order providing for rates it deems to be fair
and equitable.
    18 CFR 284.123(e) requires that within 30 days of commencement of
new service any intrastate pipeline engaging in the transportation of
gas in interstate commerce must file a statement that includes the
interstate rates and a description of how the pipeline will engage in
the transportation services, including operating conditions. If an
intrastate gas pipeline company changes its operations or rates it must
amend the statement on file with the Commission. Such amendment is to
be filed not later than 30 days after commencement of the change
operations or change in rate election.

Code of Conduct \2\
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    \2\ These code of conduct requirements were approved by OMB
originally in FERC-916 (OMB Control No. 224, current expiration date
is 9/30/2012) because there was another package related to the FERC-
549 under review at the time. These requirements are being moved to
the FERC-549 in an effort to decrease the administrative effort
involved in renewing data collections.
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    The Commission's regulations at 18 CFR 284.288 and 284.403 provide
that applicable sellers of natural gas adhere to a code of conduct when
making gas sales in order to protect the integrity of the market.
Related to the code of conduct, the Commission imposes a record
retention requirement on applicable sellers to ``retain, for a period
of five years, all data and information upon which it billed the prices
it charged for natural gas it sold pursuant to its market based sales
certificate or the prices it reported for use in price indices.'' FERC
uses these records to monitor the jurisdictional transportation
activities and unbundled sales activities of interstate natural gas
pipelines and blanket marketing certificate holders.
    The record retention period of five years is necessary due to the
importance of records related to any investigation of possible
wrongdoing and related to assuring compliance with the codes of conduct
and the integrity of the market. The requirement is necessary to ensure
consistency with the rule prohibiting market manipulation (regulations
adopted in Order No. 670, implementing the EPAct 2005 anti-manipulation
provisions \3\) and the generally applicable five-year statute of
limitations where the Commission seeks civil penalties for violations
of the anti-manipulation rules or other rules, regulations, or orders
to which the price data may be relevant.
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    \3\ 18 CFR 1c.1 and 1c.2, 71 FR 4,244 (2006).
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    Failure to have this information available would mean the
Commission is unable to perform its regulatory functions and to monitor
and evaluate transactions and operations of interstate pipelines and
blanket marketing certificate holders.

Market-Based Rates for Storage

    In 2006 the Commission amended its regulations to establish
criteria for obtaining market-based rates for storage services offered
under 18 CFR 284.501-505. First, the Commission modified its market-
power analysis to better reflect the competitive alternatives to
storage. Second, pursuant to the Energy Policy Act of 2005, the
Commission promulgated rules to implement section 4(f) of the Natural
Gas Act, to permit underground natural gas storage service providers
that are unable to show that they lack market power to negotiate
market-based rates in circumstances where market-based rates are in the
public interest and necessary to encourage the construction of the
storage capacity in the area needing storage services, and where
customers are adequately protected. These revisions are intended to
facilitate the development of new natural gas storage capacity while
protecting customers.
    Action: The Commission is requesting a three-year extension of the
FERC-549 reporting requirements, with no changes.
    Burden Statement: The estimated annual public reporting burden is
shown in the following table:
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    \4\ The number of pipelines in eTariff that are subject to the
Natural Gas Act.
    \5\ This figure is based on the burden hours estimated in Docket
No. RM09-2 (quarterly transportation and storage reports).
    \6\ The number of respondents annually is assumed to be
approximately half of the number of interstate pipelines as
estimated under the semi-annual storage report category.
    \7\ This is an estimate for the amount of time it requires to
complete a one page document, which is what is essentially required
by this part (one page from the shippers and one page from the
intrastate or LDC, equaling an estimated 2 times a year).
    \8\ This figure is based on the number of filings under 18 CFR
part 284.123 filings over the past three years.
    \9\ This figure is based on the assumption that the effort
required to make this revision to a tariff is approximately half of
the effort required to make a baseline tariff filing (as computed in
the Final Rule in Docket No. RM01-5) .
    \10\ The estimates for this category come from the Commission's
most recent renewal pertaining to this requirement.
    \11\ The estimates for this category are the same as were
submitted to OMB when these requirements were last modified (in the
Final Rule in Docket No. RM05-23).

                                                             (1)             (2)             (3)     (1) x (2) x
                                                                                (3)
----------------------------------------------------------------------------------------------------------------
Semi-Annual Storage Reports for Interstates              \4\ 155               2          \5\ 12           3,720
 284.13(e)......................................
Transportation by Interstate Pipelines                    \6\ 75               2           \7\ 3             450
 284.102(e).....................................
Rates and Charges for Intrastate Pipelines                \8\ 67               1          \9\ 12             804
 284.123(b), (e)................................
Code of Conduct \10\ (recordkeeping) 284.288,                222               1               1             222
 403............................................
Market-Based Rates \11\284.501-505..............               2               1             350             700
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           5,846
----------------------------------------------------------------------------------------------------------------

    The total estimated annual cost burden to respondents is $339,068
(5,846 hours times $58/hour \12\).
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    \12\ The per hour figures were obtained from the Bureau of Labor
Statistics National Industry-Specific Occupational and Employment
Wage Estimates (http://www.bls.gov/oes/current/naics4_221200.htm),
and are based on the mean wage statistics for staff in the areas of
management, business and financial, legal and administrative. The
mean wage was then increased by 20% to account for benefits/
overhead.
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    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, and utilizing technology and systems for the
purposes of collecting, validating, verifying, processing, maintaining,
disclosing and providing information; (3) adjusting the existing ways
to comply with any previously applicable instructions and requirements;
(4) training personnel to respond to a collection of information; (5)
searching data sources; (6) completing and reviewing the collection of
information; and (7) transmitting or otherwise disclosing the
information.
    The estimate of cost for respondents is based upon salaries for
professional and clerical support, as well as direct and indirect
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities which benefit the whole organization rather than
any one particular function or activity.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information to be collected; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including 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.

    Dated: October 24, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-27953 Filed 10-27-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 12, 2009 (Volume 74, Number 90)]
[Rules and Regulations]
[Page 22093-22094]
[DOCID:fr12my09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0120; Airspace Docket No. 09-ACE-2]

Establishment of Class E Airspace; Rushville, NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace at Rushville, NE.
Controlled airspace is necessary to accommodate Area Navigation (RNAV)
Standard Instrument Approach Procedures (SIAPs) at Modisett Airport,
Rushville, NE. The FAA is taking this action to enhance the safety and
management of Instrument Flight Rule (IFR) operations at Modisett
Airport.

DATES: Effective Date: 0901 UTC, August 27, 2009. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd, Fort

Worth, TX 76137; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On March 2, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to establish Class E airspace at
Rushville, NE, adding controlled airspace at Modisett Airport,
Rushville, NE. (74 FR 9053, Docket No. FAA-2009-0120). Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Class E airspace designations are published in paragraph
6005 of FAA Order 7400.9S signed October 3, 2008, and effective October
31, 2008, which is incorporated by reference in 14 CFR Part 71.1. The
Class E airspace designations listed in this document will be published
subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by establishing Class E airspace at Rushville, NE, adding
controlled airspace at Modisett Airport, Rushville, NE, for the safety
and management of IFR aircraft operations.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106, describes the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it adds controlled
airspace at Modisett Airport, Rushville, NE.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface

* * * * *

ACE NE E5 Rushville, NE [New]

Rushville, Modisett Airport, NE
(Lat. 42[deg]44'12'' N., long. 102[deg]26'40'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.3-mile radius of Modisett Airport.
* * * * *

    Issued in Fort Worth, TX, on April 24, 2009.
Roger M. Trevino,
Acting Manager, Operations Support Group, Central Service Center.
[FR Doc. E9-10989 Filed 5-11-09; 8:45 am]

BILLING CODE 4910-13-P


Large
                                     0.030
                                      270
                                      140

                                Incidental Oral

                                     0.028
                                      280

                                   67517-82:
                                      Cat
                                     Adult
                                    Dermal
                                      130
                                    Small
                                    0.0053
                                     1,500
                                       X

                                      310
                                    Medium
                                    0.0076
                                     1,100

                                      460
                                     Large
                                    0.0071
                                     1,100

                                   Children
                                    1 < 2
                                    Dermal
                                      130
                                    Small
                                     0.014
                                      590
                                      300

                                Incidental Oral

                                     0.013
                                      610

                                    Dermal
                                      310
                                    Medium
                                     0.020
                                      410
                                      210

                                Incidental Oral

                                     0.019
                                      430

                                    Dermal
                                      460
                                     Large
                                     0.018
                                      440
                                      220

                                Incidental Oral

                                     0.018
                                      450

                              Pump/Trigger Spray
                              2596-126, 140: Cat
                                   (Trigger)
                                     Adult
                                    Dermal
                                      250
                                    Small
                                    0.0065
                                     1,200
                                       X

                                      350

                                     Large
                                    0.0034
                                     2,300

                                   Children
                                    1 < 2
                                    Dermal
                                      250
                                    Small
                                     0.017
                                      480
                                      440

                                Incidental Oral

                                    0.0017
                                     4,700

                                    Dermal
                                      350

                                     Large
                                    0.0087
                                      920
                                      830

                                Incidental Oral

                                    0.00090
                                     8,900

                                 2596-140: Cat
                                    (Pump)
                                     Adult
                                    Dermal
                                      51
                                    Small
                                    0.0013
                                     6,000
                                       X

                                      71
                                     Large
                                    0.00070
                                    12,000

                                   Children
                                    1 < 2
                                    Dermal
                                      51
                                    Small
                                    0.0034
                                     2,400
                                     2,200

                                Incidental Oral

                                    0.00035
                                    23,000

                                    Dermal
                                      71
                                     Large
                                    0.0018
                                     4,500
                                     4,100

                                Incidental Oral

                                    0.00018
                                    43,000

                                2596-125, -140:
                                      Dog
                                   (Trigger)
                                     Adult
                                    Dermal
                                      350
                                    Small
                                    0.0045
                                     1,800
                                       X

                                      400
                                    Medium
                                    0.0022
                                     3,600

                                      700
                                     Large
                                    0.0025
                                     3,200

                                   Children
                                    1 < 2
                                    Dermal
                                      350
                                    Small
                                     0.012
                                      690
                                      620

                                Incidental Oral

                                    0.0012
                                     6,600

                                    Dermal
                                      400
                                    Medium
                                    0.0057
                                     1,400
                                     1,300

                                Incidental Oral

                                    0.00059
                                    14,000

                                    Dermal
                                      700
                                     Large
                                    0.0063
                                     1,300
                                     1,200

                                Incidental Oral

                                    0.00066
                                    12,000

1	Based on registered TCVP pet products as detailed in Table 4.0.
2	Dose (mg/kg/day) equations provided in Appendix A.
3	MOE = PoD (8.0 mg/kg/day) / Dose (mg/kg/day).
4  Total MOE = 1 / (1 / Dermal MOE) + (1 / Incidental Oral MOE), where applicable.

Residential Post-application Cancer Exposure and Risk Estimate Equations
As was done for residential handlers, post-application cancer risk estimates for adults were calculated using a linear low-dose extrapolation approach in which a LADD is first calculated and then compared with a Q1* that has been calculated for TCVP based on dose response data in the appropriate toxicology study (Q1* = 1.83 x 10[-3] (mg/kg/day)[-1]).  The algorithms used to estimate the LADD and cancer risk for residential post-application exposure can be found in Appendix A.

It should be noted that in the past, cancer risk assessments have assumed that children are no more sensitive than adults to carcinogens (i.e., no adjustment was made to children's exposure estimates in calculating a cumulative lifetime exposure).  More recently, the Agency's "Guidelines for Carcinogen Risk Assessment" (USEPA, 2005) and "Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens" (USEPA, 2005) proposed age-dependent adjustment factors to be applied to children's exposure.  These age-dependent factors are applied only to carcinogens shown to have a mutagenic mode of action.  In general, most carcinogenic pesticides have not been shown to act through a mutagenic mode of action, and thus separate assessment of children and adults is not warranted.  Any pesticide found to be a carcinogen acting through a mutagenic mode of action should be dealt with on a case by case basis, and such an assessment should follow the Agency's 2005 guidance.  The mutagenicity database for TCVP suggests that this chemical is not mutagenic in both the gene mutation assay and primary rat hepatocyte unscheduled DNA synthesis assay and, therefore, only adult cancer risk estimates have been estimated.

Days per Year of Exposure:
For purpose of estimating adult dermal cancer risks, exposure was assumed for 180 of 365 total days per year.  This factor is used as a health protective estimate of the number of days that an individual could be exposed to a treated animal per year of product use.  The recommendation of 6 months exposure is conservative, particularly when paired with the assumption that this exposure duration is repeated for 50 years during an adult's lifetime.

Years per Lifetime of Exposure:
It is assumed that adults would be exposed for 50 years out of a 78 year lifespan.  This factor is routinely used as a conservative estimate of the number of years an individual could continually use a single pesticide product.

Lifetime Expectancy: Life expectancy values are from the Exposure Factors Handbook 2011 Edition Table 18-1 (U.S. EPA, 2011).  The table shows that the overall life expectancy is 78 years based on life expectancy data from 2007.  In 2007, the average life expectancy for males was 75 years and 80 years for females.  Based on the available data, the recommended value for use in cancer risk assessments is 78 years.

Summary of Residential Post-application Cancer Exposure and Risk Estimates
Adult residential post-application dermal cancer risk estimates range from 10[-8] to 10[-6] (detailed below in Table 5.2.3).

Table 5.2.3.   Residential Post-Application Cancer Exposure and Risk Estimates from TCVP Pet Products
                                  Animal Type
                                  Animal Size
                                   Lifestage
                                   LADD[1,2]
                            Cancer Risk Estimate[3]
                                    Collar
                                 2596-49: Cat
                                     Small
                                     Adult
                                    2.2E-04
                                    4.0E-07

                                    Medium

                                    1.3E-04
                                    2.4E-07

                                     Large

                                    8.1E-05
                                    1.5E-07
                                2596-50,62: Dog
                                     Small

                                    1.8E-04
                                    3.3E-07

                                     Large

                                    8.4E-05
                                    1.5E-07
                                 2596-83: Cat
                                     Small

                                    2.3E-04
                                    4.2E-07

                                     Large

                                    1.8E-04
                                    3.3E-07
                                 2596-139: Cat
                                     Small

                                    1.9E-04
                                    3.5E-07

                                    Medium

                                    1.2E-04
                                    2.1E-07

                                     Large

                                    7.2E-05
                                    1.3E-07
                                11556-164: Dog
                                     Small

                                    2.2E-04
                                    4.0E-07

                                    Medium

                                    9.3E-05
                                    1.7E-07

                                     Large

                                    5.9E-05
                                    1.1E-07
                                11556-165: Cat
                                     Small

                                    2.7E-04
                                    5.0E-07

                                    Medium

                                    1.6E-04
                                    3.0E-07

                                     Large

                                    1.0E-04
                                    1.9E-07
                                 2596-84: Dog
                                     Small

                                    1.8E-04
                                    3.3E-07

                                     Large

                                    8.4E-05
                                    1.5E-07
                                 2596-139: Dog
                                     Small

                                    4.8E-04
                                    8.8E-07

                                    Medium

                                    2.1E-04
                                    3.8E-07

                                     Large

                                    1.3E-04
                                    2.4E-07
                                 2596-63: Cat
                                     Small

                                    2.9E-04
                                    5.3E-07

                                     Large

                                    1.2E-04
                                    2.2E-07
                                  Dust/Powder
                                47000-123: Dog
                                     Small
                                     Adult
                                    5.1E-04
                                    9.3E-07

                                    Medium

                                    5.5E-04
                                    1.0E-06

                                     Large

                                    5.6E-04
                                    1.0E-06
                                47000-123: Cat
                                     Small

                                    2.5E-04
                                    4.7E-07

                                    Medium

                                    3.7E-04
                                    6.7E-07

                                     Large

                                    3.4E-04
                                    6.3E-07
                                 2596-78: Cat
                                     Small

                                    1.7E-03
                                    3.1E-06

                                     Large

                                    1.1E-03
                                    1.9E-06
                                 2596-79: Dog
                                     Small

                                    1.4E-03
                                    2.6E-06

                                    Medium

                                    1.2E-03
                                    2.2E-06

                                     Large

                                    9.6E-04
                                    1.8E-06
                                 67517-82: Dog
                                     Small

                                    1.5E-03
                                    2.8E-06

                                    Medium

                                    1.6E-03
                                    3.0E-06

                                     Large

                                    1.7E-03
                                    3.1E-06
                                 67517-82: Cat
                                     Small

                                    7.6E-04
                                    1.4E-06

                                    Medium

                                    1.1E-03
                                    2.0E-06

                                     Large

                                    1.0E-03
                                    1.9E-06
                              Pump/Trigger Spray
                              2596-126, 140: Cat
                                   (Trigger)
                                     Small
                                     Adult
                                    4.6E-04
                                    8.3E-07

                                     Large

                                    2.4E-04
                                    4.4E-07
                                 2596-140: Cat
                                    (Pump)
                                     Small

                                    9.3E-05
                                    1.7E-07

                                     Large

                                    4.9E-05
                                    8.9E-08
                              2596-125, -140: Dog
                                   (Trigger)
                                     Small

                                    3.2E-04
                                    5.8E-07

                                    Medium

                                    1.6E-04
                                    2.9E-07

                                     Large

                                    1.7E-04
                                    3.2E-07
1	Total Lifetime Average Daily Dose (mg/kg/day) = Dermal LADD (mg/kg/day) + Inhalation LADD (mg/kg/day).
2  Dermal and Inhalation LADD equations provided in Appendix A.
3	Cancer risk estimates = Total LADD x Q1*, where Q1* = 1.83 x 10-3 (mg/kg/day)-1

	5.3 	Residential Risk Characterization

The evaluation of the potential residential post-application health risks from exposures to cats/dogs treated with TCVP pet products is conservative.  The risk estimates calculated are based upon protective assumptions of TCVP hazard, product application rates, durations of exposure, and contact with the treated animal, and they make use of the best available post-application exposure data.

Application Rate:  The application rates used in the assessment of pet products represent the maximum amount of TCVP that could be applied by weight of the treated animal (small, medium, and large) for TCVP collars, dusts/powders, and pump/trigger sprays.

For TCVP collars, the applicator is directed to cut off and dispose of any excess length once the product is fit and buckled into place.  As described in the Treated Pet SOP, because the exact length cannot be determined, the corresponding TCVP loss cannot be quantified and, therefore, exposure is assessed assuming the full collar length.  While this approach may result in an overestimate of collar application rate, it ensures protection of users who may contact dogs wearing an uncut TCVP collar.

For TCVP dusts/powders, all products identify a specific amount to use per animal weight that allows for determination of the maximum application rate.  For TCVP pump/trigger sprays, all registered products direct the user to apply a specific number of "strokes" per animal size.  In order to determine the amount of ai applied per treatment as specified by number of strokes, HED requested additional information from the product registrant.  Hartz Mountain Corporation provided information regarding the volume of product released per stroke for pump and trigger spray products; 0.19 and 0.93 grams, respectively.  Only trigger spray products are registered for dogs; however, both pump and trigger spray products are registered for cats.  Additionally, per request of HED, in March 2014 Hartz Mountain Corporation amended the master label of EPA Reg. No. 2596-140 to recommend a number of strokes per animal size.  Previously, a number of strokes per cat/dog was not recommended.  The maximum number was considered in the risk assessment for cats and dogs and based on animal size.

Exposure Data:  It is HED policy to use the best available data to assess exposure. Where chemical- or formulation-specific exposure data were available, these data were used to conduct the assessment of residential handler and post-application exposures or integrated with other data as appropriate.  The exposure estimates based on the use of these data are the most accurate representation of exposures anticipated from use of TCVP pet products and are not expected to underestimate residential risks.

All residential handler exposure estimates are based on the values recommended in the 2012 SOPs for Residential Exposure Assessment (SOPs).  For the application of TCVP dust/powder formulation exposure scenario, chemical-specific exposure monitoring data are available (MRID 45519601).  These data were previously reviewed by the Agency and determined to be acceptable for use in risk assessment.  In fact, these data have been incorporated into the calculation of the unit exposure value associated with this scenario in the 2012 Residential SOPs.  A carbaryl dust/powder exposure study is also included in the SOP unit exposure recommendation for the dust/powder exposure scenario as described in the Residential SOPs.  For purpose of the residential handler dust/powder assessment, only the TCVP unit exposure data were used.  For further information regarding how the exposure estimates were determined, please refer to the 2012 Residential SOPs where the process is explained in detail.

For the assessment of residential post-application exposures from registered TCVP products, surrogate and chemical-specific transferable residue transfer studies were used which are believed to best represent the potential exposures from TCVP use.  These residue data were collected from treated dogs after treatment with 1) TCVP aerosol, powders, and pump spray formulations (MRID 45485501) and 2) a pet collar containing the active ingredient propoxur (MRID 48589901).  HED previously completed a review of the TCVP aerosol, powder, and pump spray formulation residue transfer study for (MRID 45485501) in 2001.  That study was reevaluated based on current standards of conduct for pet residue transfer studies.  This reevaluation of the TCVP transferable residue study resulted in a number of changes from the 2001 review.  These differences are illustrated in Table 5.2.1 of this document.

The 2012 Residential SOPs: Treated Pets recommends that the fraction of applied residues which come off of a companion animal on the day of application (i.e., Day 0) should serve as the basis for assessment of post-application exposures.  This input is defined as fraction application rate (FAR) in the 2012 SOPs.  The day of application percent residue transfer values resulting from the above referenced studies used for exposure/risk quantification are as follows:  pet collars, 0.072% (arithmetic mean); dusts/powders, 0.048% (maximum observed); and pump/trigger sprays, 0.81% (maximum observed).

The TCVP powder and pump spray post-application exposure study was not conducted in a manner reflective of current standards that require a defined stroking procedure and greater number of petting simulations.  That is, the pet (cat/dog) should be stroked in a single motion with the grain of the fur starting with both sides (along the ribcage) of the animal and followed by the same motion along the back (dorsally) from the base of the neck to the tail.  The two sides and back, in this order, account for one petting simulation.  A total of 20 petting simulations (or 60 stroking motions) are currently required.  In the TCVP post-application exposure study, the dogs were stroked only one side of treated dog's back from head to rump five times.  It is also notable that the dogs were stroked with a bare hand, rather than with the currently required transferable collection method, cotton gloves worn over a mannequin hand.  Transferable residues were collected for analysis in the TCVP post-application exposure study from the bare hand using a methanol wipe.  In the current method, the cotton gloves are removed from the mannequin hand for analysis.  The mannequin hand is not analyzed, but acts only as a residue collection tool to avoid direct contact with the treated animal.  Despite these differences, the TCVP powder and pump spray post-application exposure study was reflective of current policy regarding pet residue transfer studies at the time that it was conducted.

For the reasons described in Section 5.2 of this document, HED used the maximum observed percent residue transfer on the day of product application (Day 0), as opposed to the average, for both formulations for exposure/risk quantification.  This approach results in residue transfer for pump/trigger sprays comparable to the arithmetic mean percent residue transfer observed from the analysis of all liquid formulated product data sets presented in the 2012 Residential SOPs; 0.81% and 0.96%, respectively.  The TCVP dust/powder study is the only data available for this pet product formulation and, thus, HED has no basis of comparison; however, the data are acceptable for risk quantitation and are the best available for the product type.

No exposure data are available for assessment of post-application exposures from the use of TCVP pet collars.  Two post-application exposure studies have been submitted to the Agency in support of residential pet collar uses, the aforementioned propoxur pet collar study and a recently submitted deltamethrin pet collar residue transfer study (MRID 49350101).   Both studies were conducted in a manner consistent with current standards and are recommended for use in risk quantitation.  The propoxur pet collar study resulted in mean percent residue transfer on Day 0 in excess of that of the deltamethrin study; 0.072% and 0.003%, respectively.  The more conservative mean percent residue transfer resulting from the propoxur study was selected for use as a surrogate for estimation of TCVP post-application risks.

In comparison to other formulations used for pet pest control (e.g., dusts, spot-ons, sprays), the pet collar formulation is unique and results in considerably lower percent residue transfer values.  When other pet product formulations are applied to a treated pet, it can be reasonably assumed that the entire amount of that applied (i.e., the application rate) is available on the hair coat of the animal for transfer to the exposed individual.  For example, the labeled amount of the TCVP pump/trigger spray product can be used directly in the assessment of exposure/risk because it is assumed this amount is available on the surface for contact.  Pet collar formulations operate by slowly releasing the ai from the collar medium, making them efficacious for pest treatment over longer periods of time.  Due to this activity, it can be difficult for the risk assessor to determine the amount which is initially available on the animal because the majority is retained within the collar.  Accordingly, the propoxur and deltamethrin pet collar study results in residue transfer much less than that from other, liquid formulated products.

For residential handler exposure assessment for TCVP collar products, exposure data for spot-on applications was used as a surrogate to estimate handler exposures.  For the reasons described in the preceding paragraph, the use of the spot-on applicator exposure data is highly conservative.

For purpose of quantification of estimated TCVP post-application cancer exposures/risks, HED used the mean percent residue transfer of all days sampled in the propoxur collar and TCVP dust/powder and pump spray studies.  For the TCVP collar, HED used an average FAR (of 28 days sampling in the propoxur collar study) of 0.013% to represent 180 days exposure per year.  Due to the reasons described above with use of the TCVP dust/powder and pump spray exposure data, HED used an average of the maximum observed percent residue transfer for each day tested for calculation of cancer exposures/risks resulting in an FAR of 0.022% and 0.18% for dusts/powders and pump sprays, respectively.

While the use of the maximum observed percent residue transfer on Day 0 is not typically undertaken for non-cancer or cancer residential exposure assessment, it allows for use data best representative of the exposure potential from TVCP pet products while ensuring a conservative, health protective assessment of residential risks.

Pet Contact:  For the purpose of determining exposure to treated pets, the 2012 Residential SOPs make use of transfer coefficients (TCs).  TC is an exposure rate for a selected activity which involves contact with a source, such as children playing with treated pets or on treated turf.  The TC concept is a long-standing established approach used to estimate residential, as well as occupational exposures, and is the basis for the Agency's post-application exposure guidelines.  A TC is derived by taking the ratio of study volunteer dermal exposure per unit time (mg/hr), and the concurrent measure of residue transfer.  Ideally, dermal exposure is based on an activities representative of the use pattern and residue transfer is determined by use of an established method specific to the use pattern.  For pet exposures, TCs can be defined as animal surface area contact per unit time (cm[2]/hr).

Currently, there is no exposure study available using representative, or typical adult and child activities with pets and a concurrent transferable residue (TR) measure.  In the absence of direct exposure data for residential activities with pets, the Agency concluded that studies conducted to monitor pet grooming activities are likely to result in a highly protective estimate of pet contact relative to contact associated with petting, hugging, or sleeping with a pesticide-treated pet. These data were gathered while human volunteers applied dust/powders and shampoo products to various dogs of differing sizes and fur lengths.  Since these individuals extensively handled the dogs, it is expected that their resulting exposures are higher than would be reasonably anticipated from routine contact with treated pets.  The volunteers in the shampoo study, who were professional groomers, shampooed 8 dogs for 5 minutes each, rinsed, and lifted them to counters for drying and combing resulting in very high exposures.  In the dust study, volunteers applied dust via shaker can to 8 dogs each and then rubbed the dusts into the dogs' coats.  The applicator studies were not conducted in a manner which measured TR, or active ingredient per surface area. Therefore, the residue available on the animal for transfer was predicted by multiplying the arithmetic mean fraction of application rate from the analysis of all liquid formulated product data sets presented in the 2012 Residential SOPs, 0.96%.  This approach has the effect of increasing TC estimates, thus resulting in TC values which are more protective of human health.  Furthermore, the selection of the mean value, in lieu of the screening level FAR value, 2%, further increases the TC estimates with use of the dust and shampoo studies.

Exposure Time:  The exposure time (ET) assumption used to assess residential post-application exposure to TCVP pet products is derived from a study which sought to evaluate the times that individuals spend performing different activities around the home.  Based upon the 2012 Residential SOPs: Treated Pet SOP, the point estimates recommended for adult and child ET with pets are 0.77 and 1 hours, respectively.  In the study, animal care is defined as "care of household pets including activities with pets, playing with the dog, walking the dog and caring for pets of relatives, and friends."  The data identified the time spent with an animal while performing household activities as recorded in 24 hour diaries by study volunteers.  While the activities defined do not necessarily represent the time volunteers were actively engaged in constant contact with the animal as is implicit in the post-application dermal and incidental oral algorithms, the data are the most accurate representation of time spent with pets available and, therefore, it is assumed that contact is continual throughout the timed activity.  HED assumes the ET value reflects a reasonable high end estimate of time spent in contact with a dog treated with TCVP pet products.

When use of the study data are coupled with high end assumptions of pet contact, the result is an exposure assessment that inherently implies vigorous, continual contact for the entire duration of contact.  While it is possible that an adult or child may be in close contact with a pet intermittently throughout the day, they would not be actively engaged in the highly vigorous contact implied by use of the TCs based on the applicator exposure data for the full exposure duration assumed.  Further, it is possible that adults or children may be exposed from sleeping with a treated pet; however, they are not actively engaged in a high level of contact, or the repeated mouthing behaviors exhibited by children during waking hours, which are inherently assumed in the assessment conducted.

Hazard:  The toxicology database for TCVP is complete and adequate to support the residential assessment from TCVP pet product use.  For TCVP, AChE inhibition is the most sensitive endpoint in the toxicology database in multiple species, durations, lifestages, and routes.  TCVP has low acute (lethality) toxicity by the oral, dermal, and inhalation routes of exposure.  It is classified as a Group C possible human carcinogen by the Agency with a linear low-dose approach for quantification of risk using the oral slope factor (Q1*) of 1.83 x 10[-3] (mg/kg/day)[-1].  TCVP is not mutagenic and immunotoxicity was not observed at levels that exceed the limit dose.  The FQPA SF was reduced to 1X since there is no evidence of sensitivity of the young animal in the pre- and post-natal studies compared to the adult, and there are no data gaps.

Consistent with risk assessments for other AChE-inhibiting compounds, HED conducted a BMD analysis for TCVP using a benchmark response (BMR) level of 10%, and has thus calculated BMD10 and BMDL10 values.  The use of the 10% BMR is derived from a combination of statistical and biological considerations.  A power analysis was conducted by the Office of Research and Development (ORD) on over 100 brain AChE datasets across more than 25 OPs as part of the OP cumulative risk assessment (CRA) (USEPA, 2002).  This analysis demonstrated that 10% is a level that can be reliably measured in the majority of rat toxicity studies.  In addition, the 10% level is generally at or near the limit of sensitivity for discerning a statistically significant decrease in ChE activity in the brain compartment and is a response level close to the background brain ChE level.  With respect to biological considerations, a change in 10% brain AChE inhibition is protective for downstream clinical signs and apical neurotoxic outcomes.  Based on a robust BMD analysis evaluating a broad representation of the TCVP toxicity database, points of departure were selected for the assessment of the major residential routes of exposure; dermal (handler and post-application), incidental oral (post-application only), and inhalation (handler only).

For the dermal risk assessment, a steady state PoD was selected from the subchronic oral toxicity study in rats.  Since an oral study was selected, a DAF of 9.57% was used for the route-to-route extrapolation. The DAF is based on the results of a dermal penetration study in rats. The use of the rat dermal absorption data is considered conservative because rats tend to have more permeable skin that humans (3  -  10X).  Therefore, the use of the rat DAF based on the rat dermal penetration study likely leads to an overestimation of residential dermal exposures.

Indirect Incidental Oral Exposures: An assessment of indirect incidental oral exposures resulting from children putting objects or other toys in their mouth that potentially have residue from contact with treated pets (i.e., object-to-mouth exposures) was not conducted.  The 2012 residential SOPs state that hand-to-mouth and object-to-mouth incidental oral exposures assessments should be conducted for treatments to indoor environments and lawns/turf only.  For these exposure scenarios, children's hand-to-mouth exposures are expected from direct contact with treated surfaces (i.e., treated turf and carpets/hard floors) and object-to-mouth exposures are expected due to the potential for secondary exposures from mouthing objects that may have been in contact with the treated surface.  With use of the methods described in the indoor environments and lawn/turf SOPs, the quantification of hand-to-mouth exposures following direct contact with the treated surface always results in exposures of a greater magnitude and, as a result, a more health protective assessment of risk (i.e., a lower MOE) than from indirect object-to-mouth exposures.

When the dermal and incidental oral exposure routes share a common toxicological endpoint, as is the case for TCVP, risk estimates are combined for these routes.  The incidental oral exposure scenarios (i.e., hand-to-mouth and object-to-mouth) are considered inter-related and it is likely that they occur interspersed amongst each other across time.  Accordingly, choosing the highest of the incidental oral exposure scenarios is protective of both.  Further, combining both of the incidental oral exposure scenarios with the dermal exposure scenario would be unrealistic because of the highly conservative nature of each individual assessment.  Therefore, the hand-to-mouth exposure scenario, which has the highest estimated incidental oral risk, is combined with the dermal post-application exposure and is considered a protective estimate of children's exposures following pesticide usage.  This approach is consistent with that used for assessment of post-application exposures from TCVP pet product usage.

	5.4	Residential Risk Estimates for Use in Aggregate Assessment

Tables 5.1.1, 5.2.2 and 5.2.3 reflect the residential risk estimates that are recommended for use in the aggregate assessment that will be conducted as part of the Preliminary Risk Assessment during Registration Review for TCVP.
 The recommended residential exposure for use in the adult aggregate non-cancer risk assessment is combined (dermal and inhalation) exposures from applications to large dogs with a dust/powder product (EPA Reg. No. 65717-82).
 The recommended residential exposure for use in the children 1<2 years old non-cancer aggregate assessment is combined (dermal and hand-to-mouth exposures) from post-application exposure to either small cats or large dogs from EPA Reg. Nos. 2596-78 and 67517-82, respectively.
 The recommended residential exposure for use in the adult aggregate cancer assessment is dermal exposure from the post-application exposure to large dogs from EPA Reg. No. 67517-82 (dose is 1.7E-03 mg/kg/day).

Table 5.4.  Recommendations for the Residential Exposures for the TCVP Aggregate Risk Assessment[1]
                                   Lifestage
                                  (Scenario)
                               Dose (mg/kg/day)
                                Risk Estimates

                                    Dermal
                                  Inhalation
                                     Oral
                                   Total[2]
                                    Dermal
                                  Inhalation
                                     Oral
                                 Total MOE[3]
                                    ARI[4]
                              Residential Handler
                                     Adult
                                     0.018
                                    0.00035
                                      N/A
                                     0.018
                                      440
                                     4,700
                                      N/A
                                      N/A
                                      4.2
                         Residential Post-application
                                     Child
                                     0.030
                                      N/A
                                     0.029
                                     0.059
                                      270
                                      N/A
                                      280
                                      140
                                      N/A
                                Cancer Exposure
                                     Adult
                                    1.7E-03
                                      N/A
                                      N/A
                                    1.7E-03
                                      N/A
                                      N/A
                                      N/A
                                      N/A
                                      N/A
1 Bolded worst-case risk estimates should contribute to the residential exposure portion of the aggregate assessment.
2 Total Dose (mg/kg/day) = Dermal Dose + Inhalation Dose + Incidental Oral Dose (where applicable).
3 Total MOE = 1 / (1 / Dermal MOE) + (1 / Incidental Oral MOE).
4 ARI = 1/ [(Dermal LOC (100) / Dermal MOE) + (Inhalation LOC (30) / Inhalation MOE)].

	5.5	Spray Drift

This assessment has not been conducted for the TCVP pet use products that are unlikely to result in spray drift.  Further, spray drift is not anticipated from the occupational use of TCVP for direct application to livestock or livestock premises.

	5.6	Residential Bystander Post-Application Inhalation Exposure

Residential post-application inhalation exposure is expected to be negligible from TCVP pet products and, thus, a quantitative assessment was not performed.  Per the Residential SOPs, the combination of low vapor pressure (2.6 x10[-7] mmHg at 25°C) and the small amounts of pesticide applied to pets is expected to result in negligible levels of chemical in the air, and therefore negligible inhalation exposures.

Appendix A:  Algorithms Used to Calculate Residential Non-Cancer and Cancer Risk Estimates

Dermal and Inhalation Handler Exposure Algorithm

Daily dermal and inhalation exposure (mg/day) for residential pesticide handlers, for a given formulation-application method combination, is estimated by multiplying the formulation-application method-specific unit exposure by an estimate of the amount of active ingredient handled in a day, using the equation below:

                                E = UE * AR * A

where:

E = exposure (mg/day);
UE = unit exposure (mg/lb ai);
AR = application rate (e.g., lb ai/ft[2], lb ai/gal); and
A = number of animals treated per day.

Post-application Dermal Exposure Algorithm

The following method is used to calculate dermal exposures that are attributable to an adult or child contacting a treated companion pet:

	E = TC * TR * ET

where:

      E	   = exposure (mg/day);
      TC	= transfer coefficient (cm[2]/hr);
      TR	= transferable residue (mg/cm[2]); and
      ET	= exposure time (hours/day).

	TR= AR * FARSA

where:

      TR	= transferable residue (mg/cm[2]);
      AR	= application rate or amount applied to animal (mg);
      FAR	= fraction of the application rate available as transferable residue; and
      SA	= surface area of the pet (cm[2]).

Absorbed dermal dose, normalized to body weight, is calculated as:

	D = E * AF 	BW

where:
      D	= dose (mg/kg-day);
      E	= exposure (mg/day);
      AF	= absorption factor (dermal); and
      BW	= body weight (kg).

Table A.1.  Treated Pets  -  Inputs for Residential Post-application Dermal Exposure
                              Algorithm Notation
                                Exposure Factor
                                     Units
                                Point Estimates
                                      AR
                               Application rate
                                     (mg)
                            Unique for each product
                                      SA
                            Surface Area of Animal
                                    (cm[2])
                                Small Cat, Dog
                                 Cat  -  1,500
                                 Dog  -  3,000

                                Medium Cat, Dog
                                 Cat  -  2,500
                                 Dog  -  7,000

                               Large Cat, Dog
                                 Cat  -  4,000
                                Dog  -  11,000
                                      FAR
                    Fraction of AR Available for Transfer
                         (recommended point estimate)
                                  Non-Cancer
                       Collar (Propoxur Study): 0.00072
                          Dust/Powder (TCVP): 0.00048
                           Pump Spray (TCVP): 0.0081

                                    Cancer
                       Collar (Propoxur Study): 0.00013
                          Dust/Powder (TCVP): 0.00022
                           Pump Spray (TCVP): 0.0018
                                      TC
                       Transfer Coefficient  -  Liquids
                                   (cm2/hr)
                                     Adult
                                     5,200

                          Children 1 < 2 years old
                                     1,400

                        Transfer Coefficient  -  Solids
                                   (cm2/hr)
                                     Adult
                                    140,000

                          Children 1 < 2 years old
                                    38,000
                                      ET
                                 Exposure Time
                                (hours per day)
                                     Adult
                                     0.77

                          Children 1 < 2 years old
                                      1.0
                                      BW
                                  Body weight
                                     (kg)
                                     Adult
                                      80

                          Children 1 < 2 years old
                                      11

Post-application Hand-to-Mouth Exposure Algorithm

Exposure from hand-to-mouth activity is calculated as follows (based on algorithm utilized in SHEDS-Multimedia):

	E = [HR * (FM * SAH ) * (ET * N_Replen) * (1- (1- SE) (Freq_HtM/N-Replen))]

where:

      E	= exposure (mg/day);
      HR	= hand residue loading (mg/cm[2]);
      SAH	= surface area of one child hand (cm[2]);
      FM	= fraction hand surface area mouthed /event (fraction/event);
      ET	= exposure time (hr/day);
      N_Replen  	= number of replenishment intervals per hour (intervals/hour);
      SE	= saliva extraction factor (i.e., mouthing removal efficiency); and
      Freq_HtM   	= number of hand-to-mouth contacts events per hour (events/hour).

and

	HR = E * Faihands
	          2 * SAH
where:
      HR	= hand residue loading (mg/cm[2]);
      E		= dermal exposure (mg);
      Faihands	= fraction of a.i. on hands compared to total residue from dermal transfer coefficient study (unitless); and
      SAH		= surface area of one child hand (cm[2]).

Oral dose, normalized to body weight, is calculated as:

	D = E
	         BW
where:
      D	= dose (mg/kg-day);
      E	= exposure (mg/day); and
      BW	= body weight (kg).

Table A.2.  Treated Pets  -  Inputs for Residential Post-application Hand-to-Mouth Exposure
                              Algorithm Notation
                                Exposure Factor
                                    (units)
                               Point Estimate(s)
                                   Fai hands
    Fraction of a.i. on hands from transfer coefficient studies (unitless)
                                 Solid = 0.37
                                Liquid = 0.040
                                      FM
          Fraction hand surface area mouthed /event (fraction/event)
                                     0.13
                                   N_Replen
                       Replenishment intervals per hour
                                (intervals/hr)
                                       4
                                      ET
                                 Exposure time
                                  (hours/day)
                          Children 1 < 2 years old
                                      1.0
                                      SE
                           Saliva extraction factor
                                     0.48
                                   Freq_HtM
                         Hand-to-mouth events per hour
                                  (events/hr)
                          Children 1 < 2 years old
                                      20
                                      SAH
                    Typical surface area of one child hand
                                    (cm[2])
                          Children 1 < 2 years old
                                      150
                                      BW
                                  Body Weight
                                     (kg)
                          Children 1 < 2 years old
                                      11

Cancer Exposure Algorithm

Exposure/Dose Amortization:

An accurate estimate of exposure over the course of weeks, years or a lifetime is difficult to predict as exposure likely differs from one day to the next due to product-specific application regimens, residue dissipation, human behavior and activity patterns, and the extent to which an individual's exposure varies due to behavior changes.  Approaches for amortizing dose over various exposure durations are explained in more detail in Section 1.3 of the 2012 Residential SOPs; however an example would be amortization of an individual's daily dose over their lifetime necessary for calculating exposures for cancer risk assessments.  This amortized dose is known as the lifetime average daily dose (LADD) and it can be calculated as follows:

			 LADD =        D * EF * ET
					  AT * CF

where:

      LADD	 = lifetime average daily dose (dermal + inhalation, mg/kg-day);
      D	 = dose (mg/kg-day);
      EF	 = exposure frequency (i.e., frequency of product use) (days/year);
      ET	 = exposure time (years);
      AT	 = averaging time (i.e., life expectancy) (years); and
      CF	 = conversion factor (365 days/year).

Table A.3.  Treated Pets  -  Inputs for Cancer Exposure/Risk
                              Algorithm Notation
                                Exposure Factor
                                    (units)
                               Point Estimate(s)
                                      EF
                        Exposure Frequency (days/year)
Handlers: Collars, 4;  Dusts/Powders and Pump/Trigger Sprays, 6

Post-application (all formulations): 180
                                      ET
                             Exposure Time (years)
                                      50
                                      AT
                            Averaging Time (years)
                                      78
                                      CF
                         Conversion Factor (days/year)
                                      365

Appendix B:  Summary of OPP's ChE Policy & Use of BMD Modeling

OPP's ChE policy (USEPA, 2000) describes the manner in which ChE data are used in human health risk assessment.  The following text provides a brief summary of that document to provide context to points of departure selected.

AChE can be inhibited in the central or peripheral nervous tissue.  Measurements of AChE or cholinesterase (ChE) inhibition in peripheral tissues (e.g., liver, diaphragm, heart, lung etc.) are rare.  As such, experimental laboratory studies generally measure brain (central) and blood (plasma and red blood cell [RBC]) ChE.  Blood measures do not represent the target tissue, per se, but are instead used as surrogate measures for peripheral toxicity in studies with laboratory animals or for peripheral and/or central toxicity in humans.  In addition, RBC measures represent AChE, whereas plasma measures are predominately butyryl-ChE (BuChE).  Thus, RBC AChE data may provide a better representation of the inhibition in target tissues.  As part of the dose response assessment, evaluations of neurobehavior and clinical signs are performed to consider the dose response linkage between AChE inhibition and apical outcomes.

Refinements to OPP's use of ChE data have come in the implementation of BMD approaches in dose response assessment.  Beginning with the OP cumulative risk assessment (CRA), OPP has increased its use of BMD modeling to derive PoDs for AChE inhibiting compounds.  Most often the decreasing exponential empirical model has been used.

OPP does not have a defined benchmark response (BMR) for OPs.  However, the 10% level has been used in the majority of dose response analyses conducted to date.  This 10% level represents a 10% reduction in AChE activity (i.e., inhibition) compared to background (i.e., controls).  Specifically, the BMD10 is the estimated dose where ChE is inhibited by 10% compared to background.  The BMDL10 is the lower confidence bound on the BMD10.

The use of the 10% BMR is derived from a combination of statistical and biological considerations.  A power analysis was conducted by the ORD on over 100 brain AChE datasets across more than 25 OPs as part of the OP CRA (USEPA, 2002).  This analysis demonstrated that 10% is a level that can be reliably measured in the majority of rat toxicity studies.  In addition, the 10% level is generally at or near the limit of sensitivity for discerning a statistically significant decrease in ChE activity in the brain compartment and is a response level close to the background brain ChE level.  With respect to biological considerations, a change in 10% brain AChE inhibition is protective for downstream clinical signs and apical neurotoxic outcomes.  RBC AChE inhibition data tend to be more variable than brain AChE data.  OPP begins its BMD analyses using the 10% BMR for RBC AChE inhibition. However, BMRs up to 20% could be considered on a case by case basis, as long as such PoDs are protective for brain AChE inhibition, potential peripheral inhibition, and clinical signs of neurotoxicity.

Appendix C:  Results for BMD/BMDL modeling for TCVP

BMD analyses were performed with EPA's Benchmark Dose Software (Version 2.4) using an exponential model for continuous data.  The Hill model was also performed for some data sets, but did not result in the best fit for the data.  The data selected for evaluation consisted of decreased brain and red blood cell (RBC) cholinesterase (ChE) activities.  Data were analyzed from a 21-day oral toxicity study (MRID 45570601), a 13-week subchronic oral toxicity study (MRID 43371201), and a 2 year chronic oral toxicity study (MRID 42980901); a gestational comparative cholinesterase assay (CCA; MRID 48291101); and a 28-day inhalation toxicity study (MRID 48803501).  All data from these studies were considered; however, some data were not amenable to BMD analysis.

OPP has used the exponential model for modeling AChE activity for the OP and N-methyl carbamate cumulative risk assessments and with multiple single chemical risk assessments of ChE-inhibiting pesticides.  Model runs for ChE activity were conducted with an appropriate benchmark response level (10%).  As such the BMD10 (estimated dose to result in 10% change from background levels) and BMDL10 (the lower 95% confidence level on the BMD10) are provided in the output.  Statistical (e.g., goodness of fit values) and graphical results were used in model evaluation.

The results of the repeated oral and inhalation dosing BMD analyses are summarized below in Table C.1.  Good model fit (p>0.1) was obtained for the majority of the analyses, with any exceptions being noted.

For exposure to repeated doses the BMDL10 for ChE inhibition in the adult female RBCs were similar in the 13-week subchronic study and the 21-day oral toxicity study (8.0 mg/kg/day vs 6.7 mg/kg/day, respectively).  Although data from the shorter duration study resulted in a slightly lower BMDL, visual examination of the modeled data provided greater confidence in the 13-week study.  For inhalation exposure, the adult male was about twice as sensitive as the adult female (0.023 mg/L in males vs 0.050 mg/L in females).

Table C.1.  Results of BMD Exponential Modeling for Brain and RBC ChE Data on TCVP, Repeated Oral Dosing Studies in Rats, Ranging in Duration from 21 days to 2 years.

TCVP Study

                                    Age/Sex

                                  Compartment
                                  BMD Results

                                     BMD10
                                    BMDL10
MRID 43371201
13W Oral  -  13 Weeks
                                  Adult Male
                                     Brain
                   No dose response (analysis not performed)

                                 Adult Female
                                     Brain
                               No dose response

                                  Adult Male
                                      RBC
                                61.6 mg/kg/day
                                26.3 mg/kg/day

                                 Adult Female
                                      RBC
                                10.5 mg/kg/day
                                 8.0 mg/kg/day
MRID 42980901
Chronic Oral Tox  -  364, 539, and 721 Days
                                 Adult Female
                                      RBC
        No dose-response effect was observed at 364,  539, or 721 days
MRID 45570601
21D Oral Tox  -  21 Days
                                 Adult Female
                                     Brain
                                14.7 mg/kg/day
                                12.2 mg/kg/day

                                      RBC
                                 9.9 mg/kg/day
                                 6.7 mg/kg/day
MRID 48803501
28D Inhalation  -  28 Days
                                  Adult Male
                                      RBC
                                  0.122 mg/L
                                  0.023 mg/L

                                 Adult Female
                                      RBC
                                  0.394 mg/L
                                  0.050 mg/L