U. S. Environmental Protection Agency Meeting Summary July 2, 2003 PFOA ECA Monitoring Technical Workgroup Meeting Summary, 6/ 23/ 03 56 participants; Attendance list in docket at OPPT 2003 0012 0126.

The meeting included three sections: I. Presentations on the scope of all industry LOI environmental sampling and monitoring commitments. II. Discussion/ Questions III. Identification of workgroup next steps; determination of workgroup assignments for workgroup and plenary meetings on July 9 and 10, 2003.

I. LOI Commitments  Summary of Industry Presentations The presentations on industry LOI commitments for monitoring included APFO ( ammonium perfluorooctanoate) user sites, APFO manufacturing sites, dispersion processor sites, telomer manufacturing sites, and telomer use sites. The slide presentations are available in the docket at OPPT 2003 0012 0126.

APFO User Sites The FMG presentation described their LOI monitoring commitments at APFO user sites with respect to water monitoring and air modeling for 3 pre determined sites ( DuPont Washington Works, Parkersburg, WV and the Daikin and Dyneon/ 3M plants, Decatur, AL), utilizing a phased approach where continued actions would be determined by results of the first phase. FMG reported that monitoring studies were underway at the Daikin and Dyneon/ 3M sites, and that interim reports for the Dyneon/ 3M plant are projected for September 15, 2003. FMG indicated that reports from the DuPont site have already been submitted.

FMG noted that the monitoring commitments were based on the terms contained in the multimedia consent order for the Washington Works plant signed by DuPont in November 2001. Pursuant to that order, the C8 Assessment of Toxicity Team ( CATT) was formed to determine risk based human health protective screening levels in air, water, and soil, to provide health risk information to the public, and to determine ecological health protective screening level in surface water. The CATT team determined screening levels of 150 ppb for water, 240 ppm for soil, 1 µ g/ m3 for air, and an Aquatic Life Advisory Concentration level of 1,360 ppb.

A Groundwater Investigation Steering Team ( GIST) was also formed to assess the presence and extent in drinking water, groundwater, and surface water. The scope of this team included the Washington Works as well as 3 nearby landfills.

Water monitoring included surface water at rivers and creeks upstream and downstream as well as on site, plant outfalls, and groundwater under existing sites. The CATT screening levels were used to assess results of site studies and to determine if additional action was necessary. The sampling included studies of wells in a 1 mile radius and a 2 mile radius around the Washington U. S. Environmental Protection Agency Meeting Summary July 2, 2003 2 Works, WV site. FMG reported that the results of testing were well below the CATT levels and that samples at the 2 mile radius showed decreased concentrations compared to the 1 mile radius.

Air modeling was conducted according to the Industrial Source Complex Short Term Model ( ISCST3 ) model. A site specific model was used. The procedure included EPA's Guideline on Air Quality Models 40 CFR Part 51. Certain site specific information was used as the model input, including a measured emission rate of APFO; the stack location, height, and diameter; gas exit temperature; gas flow rate ( exit velocity); and detailed plant layout/ plot plan. Air modeling data was provided for 2000, 2002 and projected values for 2003 were generated for both WV and Ohio from the Washington Works facility.

FMG indicated that ongoing water monitoring will be conducted at the Washington Works plant and 3 landfills in WV, monthly at plant outfalls and quarterly at monitoring wells. These requirements are being integrated into permits for each facility. Monitoring at public water systems of the Little Hocking Water Association, Tuppers Plains Chester Water District, and Lubeck are sampled quarterly. Off site residential wells will be sampled. GIST is developing a plan to conduct periodic monitoring of locations in both WV and OH.

FMG maintained that key lessons learned to date indicate that air modeling may help predict locations of higher ground water concentrations; that because of low surface water concentrations and low bioconcentration factors, fish testing is not justified; and that soil sampling is unnecessary because the data indicate that the tendency for adsorption onto soils is very low.

APFO Manufacturing Sites FMG noted that there is only one plant in the United States currently manufacturing APFO   the new DuPont facility in Fayetteville, NC   and that 3M is continuing to monitor its discontinued manufacturing sites in Cottage Grove, MN and Decatur, AL.

The 3M monitoring plan includes site description, ground water, and plant effluent at the Cottage Grove site; and site description, ground water, plant effluent, and environmental sampling ( surface water, sediments, and fish) at the Decatur site. A summary table was presented detailing the monitoring activity and reporting deadlines for the next 5 years at both facilities.

FMG presented further monitoring commitments for APFO manufacturing which included prestartup water testing, air dispersion modeling predictions and ongoing annual monitoring at the DuPont Fayetteville, NC facility. Emissions would include APFO plus APFO acid fluoride, emissions at capacity rates, and scrubber efficiency validated via stack testing currently underway. U. S. Environmental Protection Agency Meeting Summary July 2, 2003 3 FMG indicated that it considers air modeling to be preferable to monitoring because airborne monitoring is not practical or time efficient. FMG indicated that monitoring is slow due to low aerial concentrations, that concentrations fluctuate with time and manufacturing activity, and that detection methods are not sensitive enough for real time monitoring. FMG reported that the model correlates with surface exposure in WV.

APFO Dispersion Processor Sites FMG presented information on its Dispersion Processors Mass Balance ( DPMB), which is intended to account for the amount of APFO fluoropolymer in various compartments in industry as either being recycled, destroyed, emitted, or contained in downstream products ( commercial products in dry powder, pellets and dispersion forms). Dispersions make up a significant fraction of APFO use. Almost all remaining material ( 75%) is accounted for by recycle, destruction, air and water emissions and landfill.

FMG defined a dispersion as a water/ polymer mixture of 10e7 molecular weight polymers that do not easily dissolve in water. These aqueous dispersions are formulated into coatings that are applied to the surface of other products. There is a small amount of APFO present in the liquid dispersion as sold by the fluoropolymer manufacturers.

FMG reported that the plan for the dispersion processors mass balance includes a process description questionnaire, use and consumption data, application descriptions, and the use of validated sampling and analytical methods. Because processors are typically small companies with highly proprietary systems, a third party environmental consultant will conduct and complete the questionnaires, collect samples of process emissions ( water/ air), collect samples of input raw materials, and oversee analysis by a qualified outside laboratory. FMG indicated that data will be reported only in the aggregate by market segments to protect proprietary process and product information. FMG indicated that the laboratory has been selected and a contract is in preparation, a statement of work for the third party environmental consultant is in draft form, and the report to EPA is targeted by the end of 2003.

Telomer Sites The TRP reported that monitoring at telomer manufacturing sites will take place at the Washington Works and the Chambers Works sites. Rather than monitoring at facilities that process or use telomer based polymer products to treat paper, carpet, and textile products, however, the TRP indicated that it would use a mill pilot study to characterize emissions from processes and plants typical of each market, and that it would not commit to further testing until the results of the mill study were understood. The mill pilot study is expected to be conducted from September to the end of 2003. U. S. Environmental Protection Agency Meeting Summary July 2, 2003 4 TRP indicated that another part of the LOI commitment includes release and exposure assessments adjacent to telomer manufacturers and customer use facilities, and that an action plan needs to be developed to investigate the potential for PFOA release and exposure in US manufacturing. TRP stated that release estimates and analytical method development are underway.

The TRP noted that, at the June 6, 2003 meeting, it had proposed inclusion of the 8 2 telomer alcohol in its LOI commitments, and clarified that TRP intended to add the alcohol to the mill work and develop a valid method for alcohol analysis.

II. Discussion/ Questions:

Interested parties raised a number of questions following the industry presentations. With respect to the absence of proposals to sample soil at APFO user sites, parties questioned the conclusion that there was a low adsorption of PFOA to soil.

Concerning the dispersion processor mass balance project, parties asked whether the survey would identify downstream controls in use, including scrubbers, incinerators, and the like; FMG responded that they would be included. FMG reported that no raw data from the survey would be submitted to anyone because of confidentiality issues with the processors and antitrust and FTC prohibitions on revealing proprietary information. FMG indicated that only the third party contractor would have access to the raw data. FMG stated that there are only about 15 to 17 facilities included in their matrix, and that there may be only 2 to 3 facilities in any given cell, making it difficult for the contractor even to report aggregated data without revealing proprietary information. They noted that for some companies, fluoropolymer processing is only a small part of their overall business, and that some processors are " job shops," not dedicated production facilities. EPA expressed concern that in the absence of receiving the raw data, it would not be able to assess the information being provided.

In response to questions about monitoring at telomer manufacturing sites and about the components of the pilot mill study to characterize telomer processing and use facilities, TRP clarified that all of the telomer chemical products included in the testing are polymers, acrylates and methacrylates, in aqueous dispersions. TRP responded to comments concerning the ideal nature of the mill pilot study by observing that the study will utilize lab scale equipment known to replicate real life production processes. TRP noted that, if real manufacturing facilities were used, it would be impossible to distinguish whether any PFOA found on site was being derived from telomers or could be attributed to past use of other products with inherent PFOA contamination. TRP stated that using the mill study would allow for controls in order to determine a mass balance and to definitively determine the source of any PFOA found. TRP indicated that the lab scale equipment was used throughout the mill industries as an accepted study technique. U. S. Environmental Protection Agency Meeting Summary July 2, 2003 5 Responding to questions about whether the telomer application processes were similar for all three of the market segments TRP proposed to study, TRP indicated that telomer applications take place using dedicated pieces of equipment that apply the products in the same order at the same time in the process. TRP clarified that it would conduct mill studies for each of the three market segments, using only the most common application method, immersion.

Asked how the evaluation of groundwater would be conducted in a mill study, TRP responded that the primary potential route to groundwater through the mill is the aqueous bath going down the drain, and the mill study would measure how much was taken up by the coated products and average how much went down the drain. Questioned on how air releases would be evaluated in a mill study, and how releases and exposures could be mapped, TRP answered that the mill study would look first for pathways to the various environmental compartments, rather than analyzing for the presence of PFOA or PFOA precursors in those compartments with no indication that the process could result in there release to those media. Parties indicated concerns with the adequacy of the mill pilot study approach, including whether this small scale process would allow for the detection of low concentration materials, and questioned the TRP's decision to determine whether or not to perform higher tier testing on the findings of the mill study.

Parties raised several issues with respect to the adequacy of the monitoring programs described by industry, noting that the monitoring at the Washington Works plant did not include data elements that appeared in the EPA Preliminary Framework document, such as sediments and biota. Parties also questioned why other manufacturing sites were not included in the sampling and monitoring programs. The use in the monitoring program of the screening levels set by the WV CATT process was questioned. Parties expressed concern that the use being proposed for the levels was not appropriate, and that the levels themselves were not determined in an open, public process and exceeded internal control levels previously set by DuPont. Parties also raised the question of doing market basket sampling of food products and of doing targeted human blood sampling in the vicinity of facilities. EPA noted that blood sampling would be beyond the scope of this ECA process, as announced in the Federal Register notice, and indicated that EPA has approached CDC to request the inclusion of PFOA and other perfluorinated chemicals in the National Health and Nutrition Examination Survey ( NHANES). Industry observed that a previous market basket survey had identified PFOA in very few of the samples collected, and that it did not believe that additional food sampling would be warranted on the basis of those earlier results.

When asked why the monitoring program relied on air modeling rather than air monitoring, the industry responded that monitoring outside the plant was not feasible because there is no validated method able to detect the diluted air concentrations that might exist in a community. The industry clarified that the air modeling method did employ measured emission data points at plant stacks to inform the calculation of modeled air estimates in the community. Other parties expressed their belief that air measurement methodologies could be developed and used to allow U. S. Environmental Protection Agency Meeting Summary July 2, 2003 6 for air monitoring in communities, and questioned the absence of air model validation for the WV modeling used as the basis of the LOI commitment.

Parties asked whether the soil could be acting as a sink for previously released PFOA and other perfluorinated compounds. Questions were also raised about whether the surfactant properties and uses of PFOA might speed the movement of other chemicals through the aquifer. Parties also asked whether testing for the presence of other perfluorinated compounds should be done, not just PFOA.

III. Next Steps A: Review of LOI information by all workgroup participants. Clarification questions on the LOI presentations are due to Mary Dominiak by COB on 6/ 27. B: Summary of Workgroup meeting to be distributed in one week. C: Participants to submit questions, comments, and major topics to discuss at the next workgroup meeting to Mary Dominiak by COB on 7/ 7. D: List of questions proposed for workgroup meeting to be e mailed to participants on 7/ 8 or available in hard copy at the meeting on 7/ 9. E: Be considering workgroup spokesperson for plenary meeting on 7/ 10.


[Federal Register Volume 78, Number 16 (Thursday, January 24, 2013)]
[Proposed Rules]
[Pages 5151-5152]
[FR Doc No: 2013-01357]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-1247; Airspace Docket No. 12-ANM-27]

Proposed Amendment of Class E Airspace; Omak, WA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Omak
Airport, Omak, WA. Decommissioning of the Nondirectional Radio Beacon
(NDB) has made this action necessary for the safety and management of
Instrument Flight Rules (IFR) operations at the airport.

DATES: Comments must be received on or before March 11, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2012-
1247; Airspace Docket No. 12-ANM-27, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2012-1247 and Airspace Docket No. 12-ANM-27) and be submitted in
triplicate to the Docket Management System (see ``ADDRESSES'' section
for address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2012-1247 and Airspace Docket No. 12-ANM-27''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ``ADDRESSES'' section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by amending Class E airspace extending
upward from 700 feet above the surface and 1,200 feet above the surface
at Omak Airport, Omak, WA. The Omak NDB navigation aid is being
decommissioned and, therefore, removed from the legal description. The
size and shape of the airspace will remain the same by using the
Airport Reference Point in describing the airspace. This action would
enhance the safety and management of aircraft operations at Omak
Airport, Omak, WA.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9W, dated August 8, 2012, and effective September 15,
2012, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed 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 this proposed rule, when
promulgated, would 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 for 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 the 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 would amend controlled airspace at Omak Airport, Omak,
WA.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 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 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012 is amended as follows:

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

* * * * *

ANM WAE5 Omak, WA [Amended]

Omak Airport, WA
    (Lat. 48[deg]27'52'' N., long. 119[deg]31'05'' W.)

    That airspace extending upward from 700 feet above the surface
within a 4.3-mile radius of the Omak Airport, and within 1.8 miles
each side of the 177[deg] bearing of the Omak Airport extending from
the 4.3-mile radius to 7.5 miles south of the airport; that airspace
extending upward from 1,200 feet above the surface within 6.1 miles
east and 8.7 miles west of the 177[deg] and 357[deg] bearings of the
Omak Airport extending from 6.5 miles north to 17.9 miles south of
the airport; that airspace extending upward from 4,500 feet MSL
beginning at lat. 48[deg]00'00'' N., long. 118[deg]36'04'' W.; to
lat. 47[deg]45'00'' N., long. 118[deg]36'04'' W.; to lat.
47[deg]45'00'' N., long. 120[deg]00'04'' W.; to lat. 48[deg]00'00''
N., long. 120[deg]00'04'' W.; to lat. 48[deg]00'00'' N., long.
119[deg]35'04'' W.; to lat. 48[deg]09'37'' N., long. 119[deg]36'05''
W.; to lat. 48[deg]10'00'' N., long. 119[deg]23'04'' W.; to lat.
48[deg]00'00'' N., long. 119[deg]22'24'' W., thence to the point of
origin; that airspace extending upward from 8,500 feet MSL bounded
on the north by the U.S./Canadian border, on the east by long.
119[deg]00'04'' W., on the south by lat. 47[deg]59'59'' N., and on
the west by a line from lat. 47[deg]59'59'' N., long.
120[deg]30'04'' W.; to lat. 49[deg]00'00'' N., long. 120[deg]00'04''
W.

    Issued in Seattle, Washington, on December 6, 2012.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-01357 Filed 1-23-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 13, 2005 (Volume 70, Number 197)]
[Notices]
[Page 59744]
[DOCID:fr13oc05-86]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-690-000]

Transcontinental Gas Pipe Line Corporation; Notice of Annual
Surcharge Refund

October 5, 2005.

    Take notice that on September 29, 2005, Transcontinental Gas Pipe
Line Corporation (Transco) filed its report of Great Plains Surcharge
refunds for the period November 1, 2003 through March 31, 2004.
    Transco states that its filing complies with the Great Plains
Refund Provisions in section 39 of the general terms and conditions of
Transco's FERC Gas Tariff.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time October 13, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5629 Filed 10-12-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Page 41530]
[FR Doc No: 2021-16403]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-348, OMB Control No. 3235-0394]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 15g-5

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 15g-5--Disclosure of
Compensation to Associated Persons in Connection with Penny Stock
Transactions--(17 CFR 240.15g-5) under the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.). The Commission plans to submit this
existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Rule 15g-5 requires brokers and dealers to disclose to customers
the amount of compensation to be received by their sales agents in
connection with penny stock transactions. The purpose of the rule is to
increase the level of disclosure to investors concerning penny stocks
generally and specific penny stock transactions.
    The Commission estimates that approximately 178 broker-dealers will
spend an average of approximately 87 hours annually to comply with the
rule. Thus, the total time burden is approximately 15,486 hours per
year.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: July 28, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-16403 Filed 7-30-21; 8:45 am]
BILLING CODE 8011-01-P


1 Risk Assessment Overview  or

A Risk Assessment is Not a Number Michael S. Metzger HED Risk Assessment Training and Certification Program 2 Objectives  To Understand:

° The risk assessment paradigm ° Required toxicity studies ° Route/ duration effects on toxicity ° Standard HED risk assessments ° Endpoint selection ° Dietary assessment ° Occupational/ residential assessment 3 Objectives   To Understand:

° Drinking water assessments ° Aggregate assessment ° Cumulative assessment ° A risk assessment is not a number! 4 The Risk Assessment Paradigm:

The " Red Book"

Hazard Identification Dose Response Assessment Exposure Assessment Risk Characterization * From the National Research Council's Risk Assessment in the Federal Government: Managing the Process, 1983. http:// books. nap. edu/ books/ 030904894X/ html/ 1. html 5 Hazard Assessment: Typically Required Guideline Studies ° Acute toxicity battery ° Subchronic oral toxicity study in rats ° Subchronic dermal toxicity study in rats and rabbits ° Subchronic inhalation toxicity study in rats ° Developmental toxicity studies in rats and rabbits ° 2 Generation reproduction study in rats 6 Hazard Assessment: Required Studies ° Chronic / carcinogenicity studies in rats, dogs,

and mice ° Acute ( ACN) and subchronic ( SCN) neurotoxicity studies in rats ° Delayed neurotoxicity study in hens ° Mutagenicity testing battery ( in vitro)

° Developmental neurotoxicity study ( DNT) in rats ° Dermal absorption study ° Rat metabolism study 7 Hazard Characterization ° Important toxicological effects observed including developmental / fetal, reproductive, endocrine,

carcinogenic, and other effects ° Any critical exposure periods and routes ° Metabolism and potential for bioaccumulation ° Quality of the data and uncertainties ° Studies which provide conflicting results, and why a particular study might be deemed to be the most appropriate to rely on 8 Hazard Characterization ° Toxicity data available for related chemicals ° Pertinence of the toxicity observed to humans ° Availability of epidemiological data which supports or does not support other hazard information ° Adverse effects on wildlife that may be pertinent to human health risk assessment ° Toxic mode of action information ° Confidence in the conclusions, alternative conclusions which could be drawn, significant data gaps, and highlights of major assumptions 9 Hazard Characterization ° Each characterization factor describes our confidence in the hazard assessment, and therefore our confidence in the risk assessment  without transparent, clear, consistent,

and reasonable characterization, the assessment has little meaning A risk assessment is not a number! 10 Dose Response Assessment and Endpoint Selection ° Provides a quantitative description of the hazard potential which can be used to assess the concern for effects to people who may be exposed. 11 Dose response Assessment and Endpoint Selection: Definitions ° Endpoint: Toxic Effect upon which the risk assessment is based ° Lowest Observed Adverse Effect Level ( LOAEL): Lowest dose from a study at which adverse toxic effects were observed ° No Observed Adverse Effects Level ( NOAEL): The dose below the LOAEL at which no adverse toxic effects are observed ° Point of Departure ( POD): Any dose level used to quantify risk ( generic) 12 * NOAEL / LOAEL Dose Spacing ° NOAEL / LOAEL dose spacing usually ranges between 2X and 10X.

° True NOAEL will be somewhere between the NOAEL and LOAEL Will always lead to a conservative ( protective) hazard estimate A risk assessment is not a number! 13 Dose response Assessment and Endpoint Selection: Adverse LOAEL = Lowest Observed Adverse Effect Level LOEL = Lowest Observed Effect Level ° Effects are of concern only if they are " adverse" = " harmful"

Very minimal or adaptive effects may not be considered adverse, so would not be suitable endpoints for risk assessment 14 Dose response Assessment and Endpoint Selection: Dose " All substances are poisons; there is none which is not a poison. The right dose differentiates a poison from a remedy."

Paracelsus ( 1493 1541)

° Lower dose   lower toxicity ° Higher dose   Higher toxicity ° No exposure   No risk 15 Hazard Assessment: Hazard vs. Risk ° Hazard = toxicity ° Risk = toxicity x exposure 16 Dose response Assessment and Endpoint Selection: Duration Longer duration exposure   more severe toxicity   toxicity seen at lower doses Range of potential exposure durations must be considered in risk assessments   One dose to lifetime 17 Dose response Assessment and Endpoint Selection: Route ° 3 major routes: oral, dermal, inhalation ° Toxic effects seen   and severity of toxic effects can vary by route ° Of particular concern for portal of entry effects ° Must assure that route of dosing in animal study matches human exposure route   or characterize any mismatch 18 Dose response Assessment and Endpoint Selection Endpoints selected for risk assessment must be the most sensitive endpoint for each population, and relevant to humans.

° Most sensitive ( protective)   Most protective POD ( e. g. lowest NOAEL, highest q*)

° Relevant   Toxicity seen in animal studies could also occur in humans 19 Dose response Assessment and Endpoint Selection: Exposure Scenarios ° Dietary ° Oral food and water ( all ages)

° Residential ° Incidental oral ingestion ( children, adult swimmers)

° Dermal exposure ( all ages)

° Inhalation exposure ( adults, children indoors)

° Occupational ° Dermal and inhalation exposure ( adults) 20 Major Risk Assessments Chemical specific Cancer 6 months  lifetime Chronic 1 6 months Intermediate term ( IT) 1 30 days Short term ( ST) 1 day Acute Duration of Continuous Exposure Assessment 21 Major Risk Assessments:

" Continuous" Exposure " Continuous Exposure"

Exposure sufficiently often that cumulative toxicity from the chemical is expected to occur  or

Exposure sufficiently often that recovery from the toxic effects is unlikely to occur between doses 22 Major Risk Assessments: Acute ° One day dietary ( oral) exposure ° Food and water ° One day occupational or residential assessments ( oral, dermal, and inhalation)

° Used to refine ST assessments 23 Major Risk Assessments: Acute Endpoints typically used:

° Developmental ( teratogenic) effects ° Applicable to females of child bearing age only ° Neurotoxicity ° Applicable to everyone 24 Major Risk Assessments: Acute 1 Reproduction, rat < 1 Subchronic, mouse < 1 Chronic, monkey < 1 Chronic, rat < 1 Developmental, mouse < 1 Developmental neurotoxicity, rat 1 Subchronic neurotoxicity, rat 1 Subchronic, rat 4 Special studies 7 Subchronic, dog 22 Developmental, rabbit 30 Developmental, rat 30 Acute neurotoxicity, rat Approximate Percent of time used Study Type 25 Major Risk Assessments: Short Term ( ST)

° Duration: 1 30 days continuous exposure ° Scenarios:

° Single source occupational and residential assessments ° When residential assessments are needed,

aggregate assessments for food, water and residential ° Routes: Oral, dermal, and inhalation 26 Major Risk Assessments: Short Term ( ST)  Typical Endpoints Incidental oral ( children, adult swimmers)

° Maternal effects from developmental studies ( 14 days dosing)

° Neurotoxicity and other effects from subchronic studies Fetal developmental effects not appropriate for children 27 Major Risk Assessments: Short Term ( ST)  Typical Endpoints Dermal ° Toxicity seen in 21 day dermal toxicity study   Dermal studies not always available   Only a limited range of endpoints is measured in 21 day dermal studies 28 Major Risk Assessments: Short Term ( ST)  Typical Endpoints Dermal ° From oral studies:

° Developmental endpoints ( adult females only)

° Same as incidental oral ( adults and children)

  Must be corrected for % dermal absorption 29 Major Risk Assessments: Short Term ( ST)  Typical Endpoints Inhalation ° Toxicity seen in 28 or 90 day inhalation studies   Inhalation studies not always available   Only a limited range of endpoints is measured in most inhalation studies 30 Major Risk Assessments: Short Term ( ST)  Typical Endpoints Inhalation ° From oral studies:

° Developmental endpoints ( female adults only)

° Same as incidental oral ( adults and children)

  Must be corrected for % inhalation absorption 31 Major Risk Assessments:

Intermediate Term ( IT)

° Duration: 1 6 months continuous exposure ° Scenarios:

° Single source occupational and residential assessments ° Aggregate assessments for food, water and residential ° Routes: Oral, dermal, and inhalation 32 Major Risk Assessments: Intermediate Term ( IT)  Typical Endpoints Incidental oral ( children, adult swimmers)

° Toxic effects from subchronic or chronic studies 33 Major Risk Assessments: Intermediate Term ( IT)  Typical Endpoints Dermal ° Toxicity effects from 21 day dermal studies ° Matches exposure route ° Toxic effects from subchronic and chronic oral studies ° Matches exposure duration ° Developmental ° If most sensitive  Must determine whether using route specific or duration appropriate study is best for each chemical 34 Major Risk Assessments: Intermediate Term ( IT)  Typical Endpoints Inhalation ° Toxic effects from 90 day inhalation study ° Correct route and duration ° Toxic effects from subchronic and chronic oral studies ° Matches exposure duration ° Developmental ° If most sensitive 35 Major Risk Assessments: Chronic ° Long term dietary ( oral) exposure ° Food and water ° Long term occupational assessments ° dermal and inhalation ° Long term residential assessments ° inhalation 36 Major Risk Assessments:

Chronic   Typical Endpoints Oral and Dermal ° Toxic effects from chronic studies ° Reproductive effects   % dermal absorption correction required for dermal 37 Major Risk Assessments: Chronic   Typical Studies Used for cPAD 1 Special studies < 1 Developmental, rabbit < 1 Subchronic, mouse < 1 Subchronic, rabbit < 1 Developmental, rat < 1 Acute neurotoxicity, rat 1 Chronic, monkey 5 Subchronic, rat 5 Chronic, mouse 6 Subchronic, dog 7 Reproduction, rat 36 Chronic, rat 36 Chronic, dog Approximate Percent of time used Study Type 38 Major Risk Assessments:

Chronic   Typical Endpoints Inhalation ° Toxic effects seen in 90 day inhalation study ° Toxic effects from chronic and reproduction studies ( corrected for % inhalation absorption) 39 Major Risk Assessments: Cancer ° Non threshold ( default)

° Any exposure leads to some probability of risk ° Regulated with a q 1 *

° Threshold ( only when Mode of Toxic Action is known)

° Risk only when exposure exceeds threshold ° Regulated with an MOE, RfD, or PAD 2 major types: 40 Expressing Risk Risks in OPP are generally expressed in the following ways:

° % Reference Dose (% RfD)

° % Population Adjusted Dose (% PAD)

° Margin of Exposure ( MOE)

° Cancer Probability Units used in all assessments are mg/ kg body weight/ day 41 Expressing Risk: % Reference Dose (% RfD)

Used to express risks in acute ( aRfD) and chronic ( cRfD) dietary assessments RfD = Point of Departure ( e. g. NOAEL)

Uncertainty Factors ( except Special FQPA)

% RfD = exposure x 100 RfD  Because the Special FQPA SF must be applied in HED assessments, the RfD is now used in OPP primarily in calculating a Population Adjusted Dose ( PAD) 42 Expressing Risk: % Population Adjusted Dose (% PAD)

Used to express risks in acute ( aPAD) and chronic ( cPAD) dietary assessments PAD = Point of Departure ( e. g. NOAEL)

Uncertainty Factors ( inc. Special FQPA)

% PAD = exposure x 100 PAD 43 Expressing Risk: Margin of Exposure ( MOE)

Used to express risk for ORE assessments,

any aggregate assessment which includes an ORE component, and some cancer risks ° MOE = Point of Departure ( e. g. NOAEL)

exposure 44 Expressing Risk: RfD/ PAD vs. MOE RfD/ PAD Risk = exposure POD  As exposure increases,

% RfD/% PAD increases MOE Risk = POD Exposure  As exposure increases,

MOE decreases 45 Expressing Risk: Cancer Probability Used to express cancer risks when a nonthreshold mechanism is assumed ( q 1 *)

° q 1 * = a measure of dose response seen in cancer studies ° Risk = q 1 * x exposure 46 Dermal Absorption ° " Route to route extrapolation"   oral to dermal ° Use of an endpoint from an oral study for dermal risk assessment ° Must correct dermal exposure to account for less than 100% of the pesticide being absorbed through the skin into the body Multiply dermal exposure x % dermal absorption ( expressed as a fraction) 47 Inhalation Absorption ° " Route to route extrapolation"   oral to inhalation ° Math is identical to that used for dermal absorption ° However, since always assume 100%

inhalation absorption, use of an oral endpoint is mathematically the same as using an inhalation endpoint 48 Uncertainty and Safety Factors ° " One of several, generally 10 fold factors,

used in operationally deriving the RfD and RfC from experimental data"

( http:// www. epa. gov/ iris/ gloss8. htm)

° Intraspecies   variability among humans ° Interspecies   extrapolating animal data to humans ° Extrapolating from less than lifetime to lifetime exposures ° LOAEL to NOAEL ° Incomplete data base 49 Uncertainty and Safety Factors ° Generally 10X unless:

° A smaller factor can be shown to be protective, or ° A larger factor is clearly needed ° Maximum = 3000 50 Uncertainty Factors RfD FQPA SFs Population Adjusted D os e ( PAD)

Traditional U Fs Intraspecies Factor In tersp ecies Factor LOAEL to NOAEL Subchronic to C hronic In com ple te to C om p lete Database Special FQPA Concerns Modifying Factor Specia l FQPA Safety Factor Concerns:

° Residual concerns w ith respect to e xposure data ° Residual concern for p re and pos tnatal toxic ity Areas o f o verlap w ith T raditional UFs which d eal with d ata problems 51 Special FQPA Safety Factor Used when:

° There is concern that the NOAEL used in the risk assessment may cause risks to be underestimated because of:

° Poor dose response ° Small difference between NOAEL and LOAEL ° Concern that exposure may be underestimated 52 Uncertainty Factors What if:

° No interspecies differences ° Minimal intra species variability  Risk estimates will significantly exaggerate real risks!

A risk assessment is not a number! 53 Exposure Assessment: Chemistry and Dietary Exposure Assessment Three major Areas:

° Product Chemistry ° Residue Chemistry ° Dietary Exposure Assessment 54 Product Chemistry ° Manufacturing and Impurities ° Identifies important contaminants in pesticide products which could be of risk concern ° Physical / chemical property data ° Water solubility ° Octanol water partition coefficient ° Vapor pressure 55 Residue Chemistry Major areas include:

° Metabolism ( plant and livestock)

° Residue analytical methods ° Residue Field Trials ° Rotational crop studies ° Livestock feeding studies ° Food processing studies ° Residue monitoring studies 56 Metabolism in Plants and Livestock Nature of the Residue ( NOR) studies ° Purpose: Used to identify metabolites or degradates which might occur in foods as a result of the pesticide use, specifically:

° Which metabolites must be included in dietary risk assessment ° Which metabolites must be included in tolerance expression 57 Metabolism in Plants and Livestock Study design:

° Radiolabel the pesticide ° Apply to plant or livestock ( in feed or directly)

consistent with how pesticide will be used ° Harvest crop or livestock consistent with how pesticide will be used ° Identify and quantify radioactive products in foods 58 Metabolism in Plants and Livestock ° Include metabolites in risk assessment if:

° They are likely to be of risk concern ( i. e., both toxic and likely to result in significant exposure)

° Separate assessments may be required for metabolites likely to have significant toxicity which is different from parent compound ° Include metabolites in tolerance expression if:

° They are present in significant amounts and will be a good measure of misuse of pesticide 59 Residue Analytical Methods Designed for 3 purposes:

° Data collection in field trials ( less validation required)

° Tolerance enforcement ( ease of use and robustness are important; may be MRMs)

° Monitoring: Multi Residue Methods ( MRMs) for use in generating monitoring data for dietary risk assessment ( measure many pesticides in one analysis) 60 Residue Field Trials ° Purpose: To quantify residues in crops under a range of field conditions ° While typically 1 3 plant metabolism studies would be required to represent all crops for a chemical, 3 20 field trials will be required for each crop. 61 Residue Field Trials Study design:

° Prepare representative formulated products ° Apply each product to the crops in the field per label directions ( generally 3 20 diverse fields for each formulation)

° Harvest the plants per label directions ° Measure residues ( those required for both the tolerance and risk assessment) in all plant parts used for food or feed 62 Rotational Crop Studies ° A rotational crop is one which is planted in a field following harvest of the primary crop.

° Rotational crops can contain residues resulting from pesticide applications made to the primary crop ° Both confined ( radiolabeled) and field ( cold)

rotational crop studies may be required to identify and measure these residues 63 Livestock Feeding Studies ° Purpose: To quantify residues in meat, milk,

poultry and eggs resulting from livestock consumption of treated feed, or direct application to livestock ° While 1 livestock metabolism study is required for each type of livestock ( typically chickens and ruminants), several feeding studies are required for each 64 Livestock Feeding Studies Study design:

° Apply formulated pesticide to livestock either directly or in feed, in a manner similar to which the livestock will actually be exposed ( multiple animals)

° Analyze samples of meat, milk, poultry, and eggs for residues ( both those required for risk assessment and tolerance enforcement) 65 Food Processing Studies ° Purpose: To estimate a processing factor which describes the concentration or reduction in residue level going from the raw to processed commodity ° Required for all major processed foods 66 Food Processing Studies Study design:

° Obtain sample of raw commodity containing residues, measure residues ° Process using methods simulating commercial processing methods ° Measure residues in processed foods Processing Factor ( PF) = Residue in proc. Food Residue in raw food 67 Residue Monitoring Studies ° Not generally required, but frequently used in risk assessment ° Purposes:

° Enforcement ( targeted, less useful for risk assessment)

° Risk assessment ° Usually generated by government agencies and pesticide registrants 68 Residue Monitoring Studies ° Samples collected at various points in commerce ° Farm gate, warehouses and food distribution points,

grocery stores ° Sample collection closer to consumer  More accurate risk estimates ° Monitoring data most frequently used:

° USDA PDP data ° FDA Surveillance Monitoring ° Registrant generated special studies 69 Dietary Exposure Assessment ° Two components ° Food residues ° Food consumption 70 Dietary Exposure: Food Residues ° Residue estimates obtained from ° Field trials ( plants)

° Livestock feeding studies ( MMPE)

° Monitoring data ( various foods)

° Processing factors ( factors used in combination with field trial or monitoring data) 71 Dietary Exposure: Food Consumption ° Food consumption data obtained from the USDA's Continuing Survey of Food Intake by Individuals ( CSFII)( 1994 96,

1998 supplemental data)

° Consumption data may be grouped by various factors including age, sex,

region, ethnicity, others 72 Dietary Exposure: Food Consumption ° CSFII Survey data represent 2 nonconsecutive days for each respondent ° Used to calculate long term averages for each population subgroup ° Longitudinal ( long term) consumption data for individuals not available 73 Dietary Exposure: Calculations Exposure = Residue x Consumption Body Weight mg pest = mg pest x g food x kg food x 1 kgbw day kg food day 1000 g food kgbw Correction factor 74 Dietary Risk: Calculations Risk (% PAD) = Exposure x 100 PAD ° Equation applies to both acute and chronic dietary risk assessments 75 Dietary Risk: Acute Acute Dietary Risk:

  Risk resulting from 1 day dietary exposure ° Residue level, food consumption, and endpoint all must represent 1 day exposure or dosing 76 Acute Dietary Risks:

Two Assessment Methods ° Deterministic   less refined ( lower tier)

° Entire range of food consumption with only single, high end residue estimate ° Screening level, high end risk estimate ° Probabilistic   more refined ( higher tier)

° Entire range of both food consumption and residue levels ° More accurate risk estimate 77 Acute Dietary Risk Assessment ° Outputs for both deterministic and probabilistic assessments include exposure and risk estimates for different exposure percentiles for each population ° Deterministic assessments: Regulatory target is risk associated with 95th percentile exposure ° Probabilistic assessment: Regulate target is risk associated with 99.9th percentile exposure 78 Acute Dietary Risk Assessment:

Percentiles Everyone 95' th percentile 99.9' th percentile 79 Chronic Dietary Risk Assessment ° Risks resulting from 6 months to lifetime exposure ° Residue levels, food consumption: must be average values ° Only deterministic assessments are done since longitudinal consumption data are not available ° Output: Average exposure and risk for each population subgroup 80 Dietary Risk Assessment: Models Two models routinely used:

° Dietary Exposure Evaluation Model  Food Commodity Intake Database ( DEEM FCID)

° Models entire range of single day exposures or population averages ° Lifeline ° Models longitudinal exposures to individuals ( single day, seasonal, and lifetime) 81 Dietary Risk Characterization What factors determine how closely the risk estimates approximate real population risks?

 Estimated risks can differ by orders of magnitude when different data or methods are used. 82 Dietary Risk Characterization ° Were field trial or monitoring data used for risk drivers ( foods with highest risks)? Source of monitoring data?

° Were residues detectable or based on limits of detection?

° Were residues surface of systemic?

° What processing data were used ( commercial/ washing/ cooking/ peeling, or highend defaults)? 83 Dietary Risk Characterization ° Were high end or a distribution of residues used?

° Are residues primarily parent or more/ less toxic metabolites?

° Was percent crop treated used? 84 Dietary Risk Characterization:

Example Assume risk at 99.9' th percentile exposure = 125%

aPAD Does this mean that 0.1% of the population will get sick from exposure to pesticide residues? 85 Dietary Risk Characterization:

Example More potential concern exists if:

° Monitoring data rather than FT or feeding study data used ° A distributional rather than deterministic assessment was done ° Refined processing, cooking, washing or other data were used NO!

It means that our regulatory target has been exceeded.

 Even with the most refined exposure data, hazard conservatisms lead to protective assessments. 86 Dietary Risk Characterization:

Example Does this mean that we're never concerned with risks at 125% aPAD?

No!

It means that:

° Our regulatory target, designed to be protective in virtually all situations, has been exceeded ° We must consider the elements of the hazard and exposure characterizations to determine our degree of concern 87 Occupational and Residential Exposure ° Occupational  job related exposures ° Handler: Mix, load and apply pesticide ( agricultural, professional residential,

others)

° Post application: Reentry after application ( e. g., pickers, thinners)

° Dermal and inhalation routes 88 ° Residential  non job related exposures ° Handler: Mix, load, and apply by homeowner ° Post application: Reentry after application ( e. g., playing on lawns,

playing golf, rolling on rug)

° Dermal, inhalation, and oral routes Occupational and Residential Exposure 89 Occupational Handlers ° Application Rate: Label or usage information ( lbs. A. I./ A)

° Acres treated: Standard values from data and surveys ° Unit exposure: exposure per pound of active ingredient handled from the Pesticide Handlers Exposure Database ( PHED)

Three Major Inputs: 90 Pesticide Handlers Exposure Database ( PHED)

° PHED aggregates data for different chemicals into scenarios representative of each activity /

formulation type / PPE / etc  unit exposures ° e. g., mix/ load dry flowables, apply granules  Concept: Handler exposure is less dependent on chemical structure, more dependent on the physical processes of mixing and loading, the type of formulation, Personal Protective Equipment ( PPE),

packaging, application equipment, etc. 91 Occupational Handlers:

Calculations exposure = unit x app x acres x 1 exposure rate day BW mg = mg x lbs a. i. x A x 1 kgbw day lb a. i applied A day kgBW ° Correction may be needed for % dermal absorption 92 Occupational Post Application Workers Three major inputs:

° Dislodgable Foliar Residue ( DFR): Residue on foliage which can rub off onto worker's skin ° Transfer Coefficient ( TC): Measure of contact with foliage while performing a specific activity ° Time spent working 93 Occupational Post Application Workers ° The amount of contact with foliage while working ( TC) is not dependent on the chemical structure, but depends on the type of work, and the type and growth stage of the crop  a table of standard TCs is available for specific activities and crop types/ growth stages ° Over 4000 activity/ growth stage combinations ° The amount of residue which can rub off onto skin ( DFR) is chemical specific  DFRs must be generated for each chemical Concept: 94 Occupational Post Application:

Calculations Exposure = DFR x TC x hours x correction x 1 factor BW mg = ug x cm 2 x hours x mg x 1 Kgbw day cm 2 hour day 1000 ug kgbw ° DFRs decline over time  exposure declines over time: Used to establish reentry intervals ( REIs) 95 Residential Risk Assessments

Standard Operating Procedures for Residential Exposure Assessment (" Residential SOPs")

  Residential lawns   Gardens ( vegetable,

ornamental)

  Trees ( fruit, nut,

ornamental)

  Swimming pools   Painting / wood preserv.

  Fogging   Crack and crevice tx   Pet uses   Detergents/ hand soap   Impregnated mat.

  Termiticides   Indoor inhalation   Rodenticides   U pick 96 Occupational and Residential Exposure ° All data conditionally required ° 40 CFR 180.390, 180.440 ° May change in next revision of Part 158 ° Less robust data than for dietary exposure ° Much of data is not chemical specific, so generated by task forces 97 Occupational and Residential Exposure: Task Forces ° ARTF ( Agricultural Reentry TF):

° Occupational TCs ° ORETF ( Outdoor Residential Exposure TF):

° Lawn use exposure data ° NDETF ( Non dietary Exposure TF):

° Indoor exposure and residue data ° REJV ( Residential Exposure Joint Venture):

° Use and usage information ° AHETF ( Agricultural Handlers Exposure TF):

° PHED replacement data 98 Occupational and Residential Exposure: Data Call Ins ( DCIs)

° 1984: Field worker DCI ° 1995: Generic Post app DCI ( TCs)

° No generic request for DFR data ° 1995: Lawn uses DCI ( TCs, activity pattern, etc.)

° Handlers   No DCI ever issued 99 Drinking Water ° Two sources:

° Surface water: lakes, reservoirs, rivers ° Ground water: underground sources 100 Surface Water ( SW) Sources of Drinking Water: Monitoring ° Preferred data source  directly measures what people could be exposed to ° Rarely sufficient because of inadequate sampling, particularly for acute assessments ° Geographical representation ° Frequency of sampling ° NAWQA, STORET, registrant generated studies 101 Surface Water ( SW) Sources of Drinking Water: Models ° Used for most risk assessments ° Input: phys/ chem properties, 1/ 2 lives ° Tier 1: FQPA Index Reservoir Screening Tool ( FIRST)

° high end values for DWLOC calculations ° Tier 2: Pesticide Root Zone Model  Exposure Analysis Modeling System ( PRZM EXAMS)

° high end values for DWLOC calculations ° direct use in distributional and chronic assessments 102 Ground Water ( GW) Sources Of Drinking Water: Monitoring ° Useful for risk assessment more often than SW monitoring ° Prospective GW monitoring studies ° controlled studies at vulnerable sites ° National Water Quality Assessment ( NAWQA) program, STORET 103 Ground Water Sources of Drinking Water: Models ° Model ( SCIGROW)

° Often used for risk assessment ° Screening Concentration In GROund Water ( SCIGROW)

° Input: p chem properties, 1/ 2 lives,

chemicalspecific data ° regression model ° Can be used in DWLOC calculations, or directly as a single input value 104 Aggregate Exposure / Risk Assessment FQPA defines " safe" as:

" there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposure and all other exposure for which there is reliable information." 105 Aggregate Exposure / Risk Assessment Aggregate typically includes:

° Food ° Drinking water ° Other non occupational exposures ( e. g.

residential, playing golf)

Oral, dermal, and inhalation routes 106 Five Standard Aggregate Durations / Scenarios:

° Acute (< 1 day)

  usually dietary food and DW, occasionally includes refined residential exposures ° Short ( 1 30 days) and Int. term ( 1 6 months)

  food, DW, residential  only done when residential scenarios exist ° Chronic ( 6 months  lifetime)

  usually dietary food and DW, occasionally includes residential exposures ° Cancer:

  food, DW, residential 107 Aggregate Risk Calculations:

Population Adjusted Doses ° Used when only dietary ( oral) components are included:

% PAD agg = % PAD food + % PAD DW 108 Aggregate Risk Calculations:

MOE Approach ° Used when residential scenarios are included, and target MOEs are the same for all routes of exposure ( or for cancer assessment using MOE approach)

MOE agg = 1 1 + 1 + 1 MOE oral MOE derm MOE inhal 109 Aggregate Risk Calculations:

ARI Approach ° Aggregate Risk Index ( ARI): Used when residential scenarios are included, and target MOEs are NOT the same for all routes of exposure ARI = MOE Target MOE ARI agg = 1 1 + 1 + 1 ARI oral ARI derm ARI inhal 110 Aggregate Risk Calculations:

Cancer ( q1*) Assessment ° When cancer is quantified using a q 1 *,

aggregate by adding the cancer risk probabilities for all scenarios ° When using a q 1 *, risks quantified for general population only 111 Cumulative Risk ° Combined aggregate risks from all chemicals which have a common mode of action  or

° Combined risks from food, drinking water, and residential exposure, for all pesticides which have common toxic effects produced in the same way 112 Risk Characterization /

Risk Management ° Risk management is the decision making process involving considerations of political,

social, economic and engineering factors with relevant risk assessments relating to a potential hazard so as to develop, analyze and compare regulatory options and to select the optimal regulatory response for safety from that hazard.

° A major purpose of risk assessment is to inform risk management decisions 113 The Risk Characterization Handbook ° Transparency ° Clarity ° Consistency ° Reasonableness ° http:// www. epa. gov/ osp/ spc/ rchandbk. pdf 114 Risk Characterization: Transparency ° Clearly understood assumptions and extrapolations, impact on risk assessment ° Use of modeled vs. measured data, data gaps ° Confidence in major conclusions ° Uncertainties 115 Risk Characterization: Clarity The final product should:

° Be as brief as possible ° Use plain language ° Be understandable to the target audience 116 Risk Characterization: Consistency ° Follow statutory requirements ° Follow Agency guidance and policies ° Puts the risk assessment in context with other assessments Necessary in a regulatory context to assure a level playing field 117 Risk Characterization: Reasonableness ° Is deemed to be sound by interested parties,

using generally accepted scientific knowledge ° Based on best available science ° Provides plausible alternative estimates of risk ° Consistent with common sense 118 HED Risk Assessment Training and Certification Program Thanks for Coming


[Federal Register Volume 77, Number 68 (Monday, April 9, 2012)]
[Notices]
[Pages 21145-21146]
[FR Doc No: 2012-8453]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending March 3, 2012

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2012-0032.
    Date Filed: March 3, 2012.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: March 23, 2012.
    Description: Application of All Nippon Airways Co., Ltd. (``ANA'')
requesting an exemption and an amended foreign air carrier permit ANA
to operate the following services: (i) Scheduled foreign air
transportation of persons, property, and mail (separately or in
combination) from points behind Japan via Japan and intermediate points
to a point or points in the United States and beyond; (ii) charter
foreign air transportation of persons, property, and

mail (separately or in combination) between any point or points in
Japan and any point or points in the United States and between any
point or points in the United States and any point or points in any
third country; and, (iii) other charters.

Renee V. Wright,
 Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2012-8453 Filed 4-6-12; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Page 76377]
[FR Doc No: 2016-26474]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4285-DR; Docket ID FEMA-2016-0001]

North Carolina; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Carolina (FEMA-4285-DR), dated October 10, 2016,
and related determinations.

DATES: Effective Date: October 17, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Carolina is hereby amended to include the
following area among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of October 10, 2016.

    Craven County for Individual Assistance (already designated for
assistance for debris removal and emergency protective measures
[Categories A and B], including direct federal assistance, under the
Public Assistance program).

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-26474 Filed 11-1-16; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Pages 10752-10753]
[FR Doc No: 2012-4168]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0129]

Agency Information Collection Activities; Proposed Collection;
Comment Request; General Licensing Provisions; Section 351(k)
Biosimilar Applications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of February 15, 2012 (77 FR
8880). The document announced an opportunity for public comment on the
proposed collection of certain information by the Agency. The document
was published with an incorrect docket number. This document corrects
that error.

FOR FURTHER INFORMATION CONTACT:  Joyce Strong, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3208,

Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In FR Doc. 2012-3548, appearing on page
8880, in the Federal Register of Wednesday, February 15, 2012, the
following correction is made:
    On page 8880, in the second column, in the Docket No. heading,
``[Docket No. FDA-2012-N-1029]'' is corrected to read ``[Docket No.
FDA-2012-N-0129]''.

    Dated: February 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4168 Filed 2-22-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Notices]
[Pages 10535-10537]
[FR Doc No: 2010-4785]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61614; File No. SR-NYSEAmex-2010-17]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Amex LLC as Modified by
Amendment No. 1 Thereto Clarifying the Implementation Date of the
Amendments to NYSE Amex Equities Rule 123C To Modify the Procedures for
Its Closing Process and Make Conforming Changes to NYSE Amex Equities
Rules 13 and 15

March 1, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 25, 2010, NYSE Amex LLC (the ``Exchange'' or ``NYSE
Amex'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. On March 1,
2010, the Exchange filed Amendment No. 1 to the proposed rule change.
The Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to clarify the implementation date of the
amendments to NYSE Amex Equities Rule 123C (Market On The Close Policy
And Expiration Procedures) to modify the procedures for its closing
process; and make conforming changes to NYSE Amex Equities Rules 13
(``Definitions of Orders'') and 15 (``Pre-Opening Indications''). The
text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room, and http://www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NYSE Amex LLC (``NYSE Amex'' or the ``Exchange'') submits this
filing to clarify the implementation date of amendments to NYSE Amex
Equities Rule 123C (Market On The Close Policy And Expiration
Procedures) to modify the procedures for its closing process; and make
conforming changes to NYSE Amex Equities Rules 13 (``Definitions of
Orders'') and 15 (``Pre-Opening Indications'') approved by the
Securities and Exchange Commission on December 23, 2009 (``Close \3\
Modifications'').\4\
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    \3\ Included in these amendments were conforming changes related
to the information disseminated prior to the opening transaction are
also proposed in this filing.
    \4\ See Securities Exchange Release No. 61244 (December 28,
2009), 75 FR 479 (January 5, 2010) (SR-NYSEAmex-2009-81).
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    The Exchange notes that similar changes are proposed to the rules
of its affiliate, New York Stock Exchange LLC (``NYSE'').\5\
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    \5\ See SR-NYSE-2010-12.
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Background
    In 2009, NYSE Amex implemented changes designed to streamline and
improve the efficiency of its closing process, which included
establishing a single print for the closing transactions, activating
systemic compliance filters for market at-the-close (``MOC'') and limit
at-the-close (``LOC'') orders and enhancing the transparency of its
informational data feed for imbalances by including d-Quotes \6\ and
all other e-Quotes \7\ containing pegging instructions eligible to
participate in the closing transaction in the NYSE Amex Order Imbalance
Information datafeed.\8\
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    \6\ See definition of d-Quotes NYSE Amex Equities Rule 70,
Supplementary Material .25.
    \7\ See definition of e-Quotes NYSE Amex Equities Rule 70(a).
    \8\ See Securities Exchange Release No. 59360 (February 4,
2009), 74 FR 6936 (February 11, 2009) (SR-NYSEALTR-2009-06)
(Establishing a single print for the closing transaction). See also,
Securities Exchange Release No. 60151 (June 19, 2009), 74 FR 30653
(June 29,2009) (SR-NYSEAmex-2009-29) (Inclusion of d-Quotes and all
other e-Quotes containing pegging instructions eligible to
participate in the closing transaction NYSE Amex Order Imbalance
Information datafeed).
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    In addition, on December 23, 2009, the SEC approved the Exchanges
filing to implement Close Modifications designed to further streamline
the closing process, enhance transparency on the close and allow for
greater customer participation when there is an imbalance in a security
prior to the closing transaction. Pursuant to the Close Modifications,
NYSE Amex amended NYSE Amex Equities Rule 123C to: (i) Extend the time
for the entry of MOC/LOC orders \9\ from 3:40 p.m. to 3:45 p.m.; (ii)
amend the procedures for the entry of MOC/LOC orders in response to
imbalance publications and regulatory trading halts; (iii) change to
the cancellation time for MOC/LOC orders to 3:58 p.m.; (iv) require
only one mandatory imbalance publication; (v) rescind the provisions
governing Expiration Friday Auxiliary Procedures for the Opening and
Due Diligence Requirements; (vi) modify the dissemination of Order
Imbalance Information pursuant to NYSE Amex Equities Rule 123C(6) to
commence at 3:45 p.m.; (vii) include additional information in both the
pre-opening and pre-closing Order Imbalance Information data feeds;
(viii) amend NYSE Amex Equities Rule 13 to create a conditional-
instruction limit order type called the Closing Offset Order (``CO
order''), which may only be used to offset an existing imbalance of
orders on the close; (ix) delete the ``At the Close'' order type from
NYSE Amex Equities Rule 13 and replace it with the specific definitions
of MOC/LOC orders; and (x) codify the hierarchy of allocation of
interest in the closing transaction in NYSE Amex Equities Rule 123(C).
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    \9\ In the NYSE Amex Equities Rules and for the purposes of this
discussion, the terms ``market-on-close'' and ``limit-on-close'' are
used interchangeably with ``market-at-the-close'' and ``limit-at-
the-close''.
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Implementation of Closing Modifications
    The Exchange has not made operative the amendments described above.
Based on feedback from the member firm community, NYSE Amex has delayed
the implementation of the Closing Modifications to March 1, 2010. The
Exchange believes that commencing operation of the Closing
Modifications on March 1, 2010, will provide participants with
additional time to ensure that member firms community will be
systemically ready for to comply with the new provisions of the Rule.
    The Exchange anticipates that the Close Modifications will be
operative in all securities effective March 1, 2010; however, should
conditions arise to delay the implementation of the Close
Modifications, the Exchange will provide information to its
constituents about changes to the start date via its Trader Update
Notices that are sent via e-mail to subscribers and posted on the
Exchange's Web site.
Deletion of Erroneously Included Text
    The Exchange further proposes to delete NYSE Amex Equities Rule
123C(5)(d). Specifically, NYSE Amex Equities Rule 123C(5)(d) is
duplicative rule text. It addresses the publication of the Order
Imbalance Information data feed in the event of an early close. NYSE
Amex Equities Rule 123C(5)(d) is the exact same language as NYSE Amex
Equities Rule 123C(6)(a)(v) (``Publication of Order Imbalance
Information Data Feed''). The paragraph was inadvertently copied into
the wrong section and should therefore be deleted.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \10\ that an Exchange have rules that
are designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest. The instant proposal is in keeping
with these principles in that it provides transparency to market
participants by explaining the anticipated operation date of the Close
Modifications and the locations where market participants.
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    \10\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.\13\
However, pursuant to Rule 19b4(f)(6)(iii), the Commission may designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange requested that the
Commission waive the 30-day operative delay, as specified in Rule 19b-
4(f)(6)(iii),\14\ which would make the rule change operative
immediately. The Exchange believes that waiver of the operative delay
is appropriate because the proposed rule change is merely a
clarification of the operative date of previously approved amendments
to the Exchange's rules.
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    \13\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires the self-regulatory organization to give the
Commission notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. NYSE Amex has satisfied this requirement.
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because it merely clarifies the operative date of a previously approved
rule change. Accordingly, the Commission designates the proposed rule
change, as amended, as operative upon filing with the Commission.\15\
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    \15\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.\16\
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    \16\ 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2010-17 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEAmex-2010-17. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEAmex-2010-17 and should be submitted on or before
March 29, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-4785 Filed 3-5-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Notices]
[Page 4290]
[FR Doc No: 2012-1732]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF09-11-000]

TransCanada Alaska Company, LLC; Notice of Public Scoping Meeting
for the Planned Alaska Pipeline Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) hereby announces a public scoping meeting in Anchorage,
Alaska, for the planned Alaska Pipeline Project (APP). The meeting will
take place at:

------------------------------------------------------------------------
               Date and time                          Location
------------------------------------------------------------------------
Monday, February 13, 2012, 7 p.m.           Dena'ina Center, Kahtu Room,
                                             600 West 7th Avenue,
                                             Anchorage, AK 99501.
------------------------------------------------------------------------

    This meeting was previously cancelled on January 4, 2012, because
TransCanada Alaska Company, LLC (TC Alaska) had not filed its draft
Resource Reports, which we deemed necessary to properly evaluate and
comment on this unique and complex project. On January 13, 2012, TC
Alaska filed its draft Resource Reports, thereby allowing us to
reschedule this scoping meeting.
    More information about the Commission's environmental impact
statement, the APP, and how to file comments is available in the Notice
of Intent to Prepare an Environmental Impact Statement for the Planned
Alaska Pipeline Project and Request for Comments on Environmental
Issues (NOI), issued on August 1, 2011. The NOI describes the scoping
process that is underway seeking public participation in the
environmental review of this planned project. Please note that the
scoping period for the APP will close on February 27, 2012.

    Dated: January 20, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-1732 Filed 1-26-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Notices]
[Pages 20252-20253]
[FR Doc No: 2014-08004]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[OMB Control No. 3235-0049, SEC File No. 270-39]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form ADV.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget
(``OMB'') a request for extension of the previously approved collection
of information discussed below.
    The title for the collection of information is ``Form ADV'' (17 CFR
279.1). Form ADV is the investment adviser registration form and exempt
reporting adviser reporting form filed electronically with the
Commission pursuant to rules 203-1 (17 CFR 275.203-1), 204-1 (17 CFR
275.204-1) and 204-4 (17 CFR 275.204-4) under the Investment Advisers
Act of 1940 (15 U.S.C. 80b-1 et seq.) by advisers registered with the
Commission or applying for registration with the Commission or by
exempt reporting advisers filing reports with the Commission. The
information collected takes the form of disclosures to the adviser's
clients and potential clients. The purpose of this collection of
information is to provide advisory clients, prospective clients, and
the Commission with information about the adviser, its business, its
conflicts of interest and personnel. Clients use certain of the
information to determine whether to hire or retain an adviser.
    The information collected provides the Commission with knowledge
about the adviser, its business, its conflicts of interest and
personnel. The Commission uses the information to determine eligibility
for registration with the Commission and to manage its regulatory,
examination, and enforcement programs.
    Respondents to the collection of information are investment
advisers registered with the Commission or applying for registration
with the Commission or exempt reporting advisers filing reports with
the Commission. The Commission estimates that the total annual
reporting and recordkeeping burden of the collection of information for
each respondent is 11.42 hours.
    This collection of information is found at 17 CFR 279.1 and it is
mandatory.
    The information collected pursuant to Form ADV are filings with the
Commission. These disclosures are not kept confidential and must be
preserved until at least three years after termination of the
enterprise.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information

unless it displays a currently valid OMB control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Chief Information Officer,
Securities and Exchange Commission, c[sol]o Remi Pavlik-Simon, 100 F
Street NE., Washington, DC 20549 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: April 4, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-08004 Filed 4-10-14; 8:45 am]
BILLING CODE 8011-01-P