[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44475-44476]
[FR Doc No: 2017-20221]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-558, OMB Control No. 3235-0617]

Submission for OMB Review; Comment Request

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

Extension:
    Rule 433

    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 this request for extension of the previously approved
collection of information discussed below.

    Rule 433 (17 CFR 230.433) governs the use and filing of free
writing prospectuses under the Securities Act of 1933 (15 U.S.C. 77a et
seq.). The purpose of Rule 433 is to reduce the restrictions on
communications that an issuer can make to investors during a registered
offering of its securities, while maintaining important investor
protections. A free writing prospectus meeting the conditions of Rule
433(d)(1) must be filed with the Commission and is publicly available.
We estimate that it takes approximately 1.28 burden hours per response
to prepare a free writing prospectus and that the information is filed
by 2,906 respondents approximately 5.4026 times per year for a total of
15,700 responses. We estimate that 25% of the 1.28 burden hours per
response (0.32 hours) is prepared by the issuer for total annual
reporting burden of approximately 5,024 hours (0.32 hours x 15,700
responses).
    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 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) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/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: September 19, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-20221 Filed 9-21-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41730-41732]
[FR Doc No: 2022-14931]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0049]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Under the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by August 12, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0732. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St. North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Reporting Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic
Act

OMB Control Number 0910-0732--Extension

    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act), enacted on June 22, 2009, amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and provided FDA with
the authority to regulate the manufacture, marketing, and distribution
of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and
smokeless tobacco products to protect the public health and to reduce
tobacco use by minors. The Tobacco Control Act also gave FDA the
authority to issue regulations deeming other products that meet the
statutory definition of a tobacco product to be subject to chapter IX
of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).
    In accordance with that authority, on May 10, 2016, FDA issued a
final rule deeming all products that meet the statutory definition of
tobacco product, except accessories of newly deemed tobacco products,
to be subject to FDA's tobacco product authority (final deeming rule)
(81 FR 28974).
    Chapter IX of the FD&C Act now applies to newly regulated products,
including sections 904(a)(3) and (c)(1) (21 U.S.C. 387d(a)(3) and
(c)(1)). Section 904(a)(3) of the FD&C Act requires the submission of
an initial report from each tobacco product manufacturer or importer,
or agents thereof, listing all constituents, including smoke
constituents as applicable, identified as a harmful and potentially
harmful constituent (HPHC) to health by FDA. Reports must be by brand
and by quantity in each brand and subbrand. We note that for
cigarettes, smokeless tobacco, cigarette filler, and RYO tobacco
products, this initial reporting was completed in 2012.
    Section 904(c)(1) of the FD&C Act provides that manufacturers of
tobacco products not on the market as of June 22, 2009, must also
provide the information reportable under section 904(a)(3) of the FD&C
Act at least 90 days prior to introducing the product into interstate
commerce.
    FDA has taken several steps to identify HPHCs to be reported under
section 904 of the FD&C Act, including issuing a guidance discussing
FDA's current thinking on the meaning of the term ``harmful and
potentially harmful constituent'' in the context of implementing the
HPHC list requirement under section 904(e) of the FD&C Act (76 FR 5387,
January 31, 2011, revised guidance issued August 2016). The guidance is
available on the internet at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmful-and-potentially-harmful-constituents-tobacco-products-used-section-904e-federal-food-drug. The current established list of HPHCs also is available on the
internet at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list (77 FR 20034, April 3, 2012).
    The purpose of the information collection is to collect statutorily
mandated information regarding HPHCs in certain tobacco products and
tobacco smoke, by brand and by quantity in each brand and subbrand.
    To facilitate the submission of HPHC information, Forms FDA 3787a-
j, for cigarettes, smokeless tobacco products, and RYO tobacco
products, respectively, in both paper and electronic formats, are
available. Additionally, FDA is developing forms to facilitate the
submission of HPHC information for the deemed tobacco products. We
intend to model these forms on the current HPHC reporting forms (i.e.,
Forms FDA 3787a-j). A proposed information collection for deemed
products will be published in a separate Federal Register notice, and
we will solicit comments on that collection at that time.
    Manufacturers or importers, or their agents, may submit HPHC
information either electronically or in paper format. The FDA
eSubmitter tool, available at https://www.fda.gov/industry/fda-

esubmitter/using-esubmitter-prepare-tobacco-product-submissions,
provides electronic forms to streamline the data entry and submission
process for reporting HPHCs for cigarettes, smokeless tobacco products,
and RYO tobacco products. Users of eSubmitter may populate an FDA-
created Excel file and import data into eSubmitter. Whether respondents
decide to submit reports electronically or on paper, each form provides
instructions for completing and submitting HPHC information to FDA. The
forms contain fields for company information, product information, and
HPHC information.
    In the Federal Register of February 7, 2022 (87 FR 6869), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We have adjusted estimates in the number of respondents and
responses per respondent from the 60-day Federal Register notice to
better align with previous assessments that utilized the number of
entities. The number of respondents now reflects the estimated number
of cigarettes, RYO, and smokeless tobacco product manufacturers,
importers, or their agents. The burden totals were unchanged from the
60-day notice.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual   Average burden     Total hours
                                  respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
                                    Reporting for Section 904(c)(1) Products
----------------------------------------------------------------------------------------------------------------
      1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
Cigarette.....................              48            7.92             380            1.82               692
RYO...........................              43            0.44              19            0.43                 8
Smokeless.....................              34            0.74              25            0.63                16
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ..............               716
----------------------------------------------------------------------------------------------------------------
                                    2. Testing of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler and RYO......              43            0.44              19            9.42               179
Smokeless.....................              34            0.74              25           12.06               302
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ..............               481
----------------------------------------------------------------------------------------------------------------
                                3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: ISO Regimen........              48            7.92             380           23.64             8,983
Cigarette: Health Canada                    48            7.92             380           23.64             8,983
 Regimen......................
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ..............            17,996
                               ---------------------------------------------------------------------------------
        Total Section           ..............  ..............  ..............  ..............            19,193
         904(c)(1) Reporting
         Burden Hours.........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate for this collection of information includes the
time it will take to read the instructions, test the products, and
prepare the HPHC report. In arriving at this burden estimate, FDA
estimated the number of tobacco products to be reported under the
requirements of section 904(c)(1) of the FD&C Act annually to FDA.
    Section 1 of Table 1 estimates that 125 respondents (48 cigarette,
43 RYO, and 34 smokeless tobacco product manufacturers, importers, or
their agents) will submit 424 HPHC reports annually. Each respondent
must report their product information to FDA under section 904(c)(1) of
the FD&C Act at least 90 days prior to delivery for introduction into
interstate commerce for all new products. We have adjusted information
in the number of respondents and responses per respondent from the 60-
day Federal Register notice to better align with previous assessments.
The number of respondents now reflects the estimated number of
cigarettes, RYO, and smokeless tobacco product manufacturers,
importers, or their agents. This section addresses the time required to
report their company information to FDA using the electronic portal or
paper forms.
    The company information reported includes company name; mailing
address; telephone and fax numbers; FDA Establishment Identifier
number; Data Universal Numbering System number; and point of contact
name, mailing address, and telephone and fax numbers, as applicable. It
also addresses the time required for manufacturers and importers to
report their product information by entering certain testing
information into the electronic or paper forms.
    The product information includes brand and subbrand name; unique
product identification number; type of product identification number;
product category and subcategory; and mean weight and standard
deviation of tobacco in product.
    We estimate that the burden to enter both the company and product
information is no more than 1.82 hours per response for cigarettes,
0.43 hours per response for RYO, and 0.63 hours per response for
smokeless tobacco products regardless of whether the paper or
electronic Form FDA series 3787 is used. The time to report per tobacco
product types varies because the number of HPHCs varies by tobacco
product category. The total hours estimated for this section is 716.
    The estimated total annual responses under section 904(c)(1) are
based on FDA's experience and the past 4 years of tobacco products
receiving marketing authorizations from FDA, and the requirements to
submit HPHC data

under this provision of the FD&C Act for statutorily regulated
products.
    Section 2 of Table 1 estimates that 77 respondents (43 cigarette
filler and RYO tobacco and 34 smokeless manufacturers, importers, or
their agents) will test quantities of HPHCs in an average of 44
products annually. This section addresses the time required for
manufacturers and importers (or their agents) who must test HPHC
quantities in products. The burden estimates include the burden to test
the tobacco products, draft testing reports, and submit the report to
FDA. The total expected burden for this section is 481 hours.
    Section 3 of Table 1 addresses the time required for manufacturers
and importers to test quantities for HPHCs in cigarette smoke. The
burden estimates include: the burden to test the number of replicate
measurements; test date range; manufacture date range; extraction
method; separation method; detection method; and mean quantity and
standard deviation of HPHCs and includes the burden to test the tobacco
products, draft testing reports, and submit the report to FDA. The
annual burden reflects our estimate of the time it takes to test the
tobacco products (i.e., carry out laboratory work). The burden estimate
assumes that manufacturers and importers report HPHC quantities in
cigarette mainstream smoke according to both the ISO and Health Canada
smoking regimens. The total expected burden is 17,996 hours for this
section.
    The total estimated burden for this information collection is
expected to be 19,193 hours and 424 annual responses. Our estimated
burden for the information collection reflects an overall increase of
354 annual responses and a corresponding increase of 16,677 hours. We
attribute this adjustment to updated methodology in which the current
estimates are derived from historical statutory tobacco product
applications submitted and authorized by FDA in the past 4 years as:
(1) manufacturers and importers (or their agents) of authorized
products are required to submit HPHC reports at least 90 days prior to
delivery for introduction into interstate commerce for all new
products; and (2) initial reporting under section 904(a)(3) of the FD&C
Act for statutory products was completed in 2012.

    Dated: July 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14931 Filed 7-12-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42903-42904]
[FR Doc No: 2018-18305]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3030]

Site Visit Training Program for Office of Pharmaceutical Quality
Staff; Information Available to Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Center for Drug Evaluation and Research (CDER) in the Food
and Drug Administration (FDA) is announcing the Fiscal Year 2019 CDER
Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site
Visit Program. The purpose of this document is to invite pharmaceutical
companies interested in participating in this program to submit a site
visit proposal to CDER's OPQ.

DATES: Submit either an electronic or written proposal to participate
in this program by November 23, 2018. See section IV of this document
for information on what to include in such proposals.

FOR FURTHER INFORMATION CONTACT: Janet Wilson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4642, Silver Spring, MD 20993-0002, 240-
402-3969, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    A critical part of the commitment by CDER to make safe and
effective high-quality drugs available to the American public is
gaining an understanding of all aspects of a drug's development and
commercial life cycle, including the variety of drug manufacturing
operations. To support this commitment, CDER has initiated various
training and development programs including the FY2019 Experiential
Learning Site Visit program. This site visit program is designed to
offer experiential and firsthand learning opportunities that will
provide OPQ staff with a better understanding of the pharmaceutical
industry and its operations, as well as the challenges that impact a
drug's developmental program and commercial life cycle. The goal of
these visits is to enhance OPQ staff exposure to the drug development
and manufacturing processes in industry; therefore, a tour of
pharmaceutical company facilities, including manufacturing and
laboratory operations, is an integral part of the experience.

II. The Site Visit Program

    In this site visit program, groups on average of 15 to 20 OPQ
staff--who have experience in a variety of backgrounds, including
science, medicine, statistics, manufacturing, engineering, testing, and
project management--will observe operations of commercial
manufacturing, pilot plants (if applicable), and testing over a 1- to
2-day period. To facilitate the learning process for OPQ staff,
overview presentations by industry related to drug development,
manufacturing and testing may be included.
    OPQ encourages companies engaging in the development and
manufacturing of both active pharmaceutical ingredients (small and
large molecules) and drug products to respond. Please note that this
site visit program is not intended to supplement or replace a
regulatory inspection, e.g., a preapproval inspection, prelicense
inspection, or a surveillance inspection.

    OPQ staff participating in this program will benefit by gaining a
better understanding of current industry practices, processes, and
procedures. Participating sites will have an opportunity to showcase
their technologies and their actual manufacturing and testing
facilities.
    Although observation of all aspects of drug development and
production would be beneficial to OPQ staff, OPQ has identified a
number of areas of particular interest to its staff. The following list
identifies some examples of these areas but is not intended to be
exhaustive, mutually exclusive, or to limit industry response:

 Drug products
[cir] Solutions, suspensions, emulsions, and semisolids
[cir] Modified- and immediate-release formulations
[cir] Drug-device combination products (e.g., inhalation products,
transdermal systems, implants intended for drug delivery, and prefilled
syringes)
 Active pharmaceutical ingredients manufactured by
[cir] Chemical synthesis
[cir] Fermentation
[cir] Biotechnology
 Design, development, manufacturing and controls
[cir] Engineering controls for aseptic processes
[cir] Novel delivery technologies
[cir] Hot melt extrusion
[cir] Soft-gel encapsulation
[cir] Lyophilization
[cir] Blow-Fill-Seal and isolators
[cir] Spray-drying
[cir] Process analytical technology, measurement systems, and real-time
release testing
 Emerging technologies
[cir] Continuous manufacturing
[cir] 3-dimensional printing
[cir] Nanotechnology

III. Site Selection

    Selection of potential facilities will be based on the priorities
developed for OPQ staff training, the facility's current compliance
status with FDA, and in consultation with the appropriate FDA district
office. All travel expenses associated with this program will be the
responsibility of OPQ; therefore, selection will be based on the
availability of funds and resources for the fiscal year. OPQ will not
provide financial compensation to the pharmaceutical site as part of
this program.

IV. Proposals for Participation

    Companies interested in offering a site visit or learning more
about this site visit program should respond by submitting a proposal
directly to Janet Wilson (see DATES and FOR FURTHER INFORMATION CONTACT
sections of this document for more information). To aid in OPQ's site
selection and planning, your proposal should include the information
below:
     A contact person,
     Site visit location(s),
     Facility Establishment Identifier and Data Universal
Numbering System numbers, as applicable,
     Maximum number of FDA staff that can be accommodated
during a site visit (maximum of 20),
     A proposed agenda outlining the learning objectives and
associated activities for the site visit,
     Maximum number of site visits (no more than 2) that your
site would be willing to host by the close of the government fiscal
year, September 30, 2019, and
     Proposed dates for each site visit (i.e. month and week).
    Please note that the requested proposed agenda will be reviewed to
determine the educational benefit to OPQ in conducting the visit, and
selected sites may be asked to refine the agenda to maximize the
educational benefit. After a site is selected, OPQ will communicate
with the contact person for the site to determine the actual dates for
the visit.
    Proposals submitted without this minimum information will not be
considered. Based on response rate and type of responses, OPQ may or
may not consider alternative pathways to meeting our training goals.

    Dated: August 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18305 Filed 8-23-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 8, 2009 (Volume 74, Number 108)]
[Notices]
[Page 27133-27134]
[DOCID:fr08jn09-38]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13365-000]

City of Angoon; Notice of Preliminary Permit Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

June 1, 2009.
    On February 5, 2009 and supplemented on May 14, 2009, the City of
Angoon filed an application for a preliminary permit, pursuant to
section 4(f) of the Federal Power Act, proposing to study the
feasibility of the Scenery Lake Hydroelectric Project located on
Scenery Lake and Scenery Creek, near the town of Petersburg, Alaska.
The project would be located within the Tongass National Forest, with a
portion of the transmission line crossing the state of Alaska and city
of Petersburg's lands. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of: (1) A 120-foot-high concrete
arch dam with spillway impounding Scenery Lake having a surface area of
520 to 820 acres and a storage capacity of 58,000 to 80,000 acre-feet;
(2) a lake tap or siphon with fish screen; (3) a 13,000-foot-long by 8-
foot-diameter power conduit; (4) a powerhouse containing two to four
new generating units having an installed capacity of 40 megawatts; (5)
a proposed 29-mile-long, 69- and 138-kilovolt transmission line; and
(6) appurtenant facilities. The proposed Scenery Lake Project would
have an average annual generation of 80 gigawatt-hours.
    Applicant Contact: Albert Howard, Mayor, City of Angoon, P.O. Box
189, Angoon, AK 99820; phone:<PHONE_NUMBER>.
    FERC Contact: Gina Krump,<PHONE_NUMBER><EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications

(without notices of intent), or notices of intent to file competing
applications: 60 days from the issuance of this notice. Comments,
motions to intervene, notices of intent, and competing applications may
be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project, including a copy of
the application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13365) in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-13237 Filed 6-5-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 7, 2005 (Volume 70, Number 214)]
[Notices]
[Page 67525-67527]
[DOCID:fr07no05-114]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52705; File No. SR-NASD-2004-013

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Order Granting Approval to Proposed Rule Change and
Amendments Nos. 1 and 2 Thereto, and Notice of Filing and Order
Granting Accelerated Approval To Amendment No. 3, To Amend NASD Rules
for Mediation Proceedings

October 31, 2005.

I. Introduction

    On January 23, 2004, the National Association of Securities
Dealers, Inc. (``NASD''), through its wholly-owned subsidiary, NASD
Dispute Resolution, Inc., filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to simplify the language of the
mediation portion of the NASD Code of Arbitration Procedure (``Code'')
and to reorganize those provisions into a separate code for mediations
(``Mediation Code'').\3\

Amendments Nos. 1 and 2 were filed on January 3, 2005 and April 8,
2005, respectively.\4\ Notice of filing of the proposed rule change and
Amendments Nos. 1 and 2 were published for comment on June 23, 2005.\5\
The Commission received one comment letter on the proposal.\6\ NASD has
filed Amendment No. 3 to change the numbering of the proposed Mediation
Code and to make other non-substantive revisions, in order to
facilitate approval of the proposed rule change \7\ prior to the
approval of the two other rule filings relating to the revision and
reorganization of the Code. This order approves the proposed rule
change and Amendments Nos. 1 and 2 thereto, and issues notice of and
grants accelerated approval to Amendment No. 3.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ As explained in more detail below, the proposed Mediation
Code is one of three NASD rule proposals that, taken together, would
simplify the language of and reorganize the Code. See also
Securities Exchange Act Rel. No. 51856 (June 15, 2005); 70 FR 36442
(June 23, 2005) (proposing to revise and create a separate code for
NASD arbitration rules pertaining to customer disputes (``Customer
Code'')); Securities Exchange Act Rel. No. 51857 (June 15, 2005); 70
FR 36430 (June 23, 2005) (proposing to revise and create a separate
code for NASD arbitration rules pertaining to industry disputes
(``Industry Code'')).
    \4\ Amendment No. 1 deleted a provision that was inadvertently
included in the initial rule filing. This provision pertained to a
mediator's disqualification as an expert in any pending or future
proceeding related to the subject matter of the mediation, and the
unavailability of the mediator's documents in such a proceeding.
Amendment No. 2 made certain conforming changes also proposed in the
other rule filings relating to the revision and reorganization of
the Code. Specifically, it added references in the definitions rule
to NASD's By-laws and clarified the definition of ``quorum'' for
purposes of meetings of the National Arbitration and Mediation
Committee, consistent with the Plan of Allocation and Delegation of
Functions by NASD to Subsidiaries.
    \5\ See Securities Exchange Act Rel. No. 51855 (June 15, 2005);
70 FR 36440 (June 23, 2005).
    \6\ See letter to Jonathan G. Katz, Secretary, Commission, from
Pace Investor Rights Project, by Jill I. Gross and Barbara Black,
dated July 14, 2005 (``Pace Letter'').
    \7\ NASD has requested accelerated approval for Amendment No. 3.
Telephone Conversation with Mignon McLemore, Assistant Chief
Counsel, NASD Dispute Resolution, Inc. (Oct. 19, 2005).
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

A. Description of the Proposed Rule Change

    This rule filing is part of a comprehensive plan to simplify and
reorganize NASD's dispute resolution rules. NASD has proposed to
rewrite the Code using plain English, in accordance with the
Commission's plain English guidelines. In addition, it has proposed to
reorganize the Code in a more logical, user-friendly way by, among
other things, creating two separate codes for customer and industry
arbitrations, and one for mediations. Once approved, the three new
codes will replace the current NASD Code in its entirety.
    Although NASD is proposing to implement several substantive rule
changes to its arbitration rules, as described in the Customer Code and
Industry Code rule filings,\8\ NASD believes it has not proposed any
substantive changes to the current rules governing mediations, apart
from adding a definitions rule. The text of the proposed Mediation
Code, including the technical changes proposed in Amendment No. 3, is
available on the NASD Web site at http://www.nasd.com/ web/

idcplg?IdcService= SS--GET--PAGE&ssDocName= NASDW--
009003&ssSourceNodeId= 801.
---------------------------------------------------------------------------

    \8\ See supra note 3.
---------------------------------------------------------------------------

1. Reorganization
    NASD believes that maintaining three separate codes will make it
easier for parties to find the rules that apply to their disputes. NASD
will maintain electronic versions of each code on its Web site, http://www.nasd.com
, and will make paper copies available upon request.

    In keeping with the current NASD rule numbering system, each of the
three codes will be numbered in the thousands, and major sections will
be numbered in the hundreds. Individual rules within those sections
will be numbered in the tens (or ones, if necessary). The current
method for numbering and lettering paragraphs within individual rules
will remain unchanged. The Customer Code will use the Rule 12000
series, the Industry Code will use the Rule 13000 series, and the
Mediation Code ultimately will use the Rule 14000 series, all of which
are currently unused. NASD intends to reserve the Rule 10000 series,
which is currently used for NASD's dispute resolution rules, for future
use.
2. Proposed Definitions Rule
    The Mediation Code will include a comprehensive definitions rule
that will define terms used throughout the Mediation Code. NASD
believes that this rule will provide useful clarification for parties
and mediators.
3. No Substantive Changes
    NASD believes that, with the exception of adding a definitions
rule, the Mediation Code will not include any substantive changes to
NASD's current rules governing mediations.

B. Amendment No. 3

    Originally, NASD anticipated that the proposed Mediation Code would
be approved at the same time as the Customer Code and Industry Code.
Therefore, NASD proposed numbering the Mediation Code using the 14000
series. However, in order to facilitate approving the proposed
Mediation Code before the Customer Code and Industry Code, NASD
proposes in Amendment No. 3 to change its numbering and to make other
non-substantive changes, such that it is consistent with the current
Code. NASD intends to propose to renumber the approved Mediation Code
as the 14000 series when the Customer Code and Industry Code are
approved and become effective.
    Specifically, the changes proposed in Amendment No. 3 are as
follows:
     The current NASD mediation rules, current Rules 10401-
10407 of the Code, would be deleted in their entirety. They would be
replaced by Rules 14100-14109 of the proposed Mediation Code, which
would be renumbered as Rules 10401-10410, to remain consistent with the
numbering in the current Code. NASD intends to propose to renumber the
Mediation Code in the NASD Manual as the 14000 Series when the Customer
Code and Industry Code are approved by the Commission.\9\
---------------------------------------------------------------------------

    \9\ The Commission notes that approval of the proposed Mediation
Code does not predispose the Commission to approving the proposed
rule changes relating to the Customer Code or Industry Code.
---------------------------------------------------------------------------

     Proposed Rule 10401(g) of the Mediation Code defines
``NASD Customer Code.'' This paragraph would be reserved until the
Customer Code is approved. NASD intends to propose to reinsert the
definition into the Mediation Code at that time.
     Proposed Rule 10401(h) of the Mediation Code defines
``NASD Industry Code.'' This paragraph would be reserved until the
Industry Code is approved. NASD intends to propose to reinsert the
definition into the Mediation Code at that time.
     In proposed Rule 10405(b), the phrase ``NASD Code of
Arbitration Procedure'' would replace ``NASD Customer Code'' or ``NASD
Industry Code.'' NASD intends to propose to reinsert those terms when
the Customer Code and Industry Code are approved.
     In proposed Rule 10406(b), the term ``adjournment'' would
replace the term ``postponement,'' consistent with the current Code.
NASD intends to propose to change the term back to ``postponement''
when the Customer Code and Industry Code are approved.
     In proposed Rule 10407(c), references to ``Rule 10312(a),
(b), and (c) of the NASD Code of Arbitration Procedure'' would replace
references to ``NASD Customer Code Rule 12408'' or ``NASD Industry Code
Rule 13408.'' NASD intends to propose to change the reference back to
``NASD Customer Code Rule 12408'' or ``NASD Industry Code Rule 13408,''
as appropriate, when the Customer and Industry Codes are

approved. These cross references pertain to disclosures mediators are
required to make in connection with interests, relationships, or
circumstances which might influence their objectivity and impartiality.

C. Comment Summary

    The Commission received one comment letter on the proposed
Mediation Code, in which the Pace Investor Rights Project endorsed the
proposed rule change because it preserves the existing NASD mediation
system, while allowing individual investors to better understand the
mediation rules through plain English.\10\ Pace generally supports the
mediation of securities disputes and cites Professor Jill Gross for her
conclusion in a forthcoming article that mediation is fair to the
individual investor because it maximizes party control over the process
and offers procedural justice at relatively low cost, among other
things.\11\
---------------------------------------------------------------------------

    \10\ Pace Letter.
    \11\ Id.
---------------------------------------------------------------------------

III. Discussion and Findings

    After careful consideration, the Commission finds that the proposed
rule change, as amended, is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities association \12\ and, in particular, the requirements of
Section 15A of the Act \13\ and the rules and regulations thereunder.
The Commission finds that the proposed rule change, as amended, is
consistent with Section 15A(b)(6) of the Act,\14\ which requires, among
other things, that the rules of an association be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, and, in general, to protect investors
and the public interest.\15\ The Commission believes that proposed rule
change, as amended, accomplishes these goals by improving the
readability, accessibility, and therefore usability of procedures that
establish an alternative, voluntary, and potentially low-cost forum for
dispute resolution in the securities industry.
---------------------------------------------------------------------------

    \12\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78o-3.
    \14\ 15 U.S.C. 78o-3(b)(6).
    \15\ Id.
---------------------------------------------------------------------------

    The Commission believes that there is good cause for approving
Amendment No. 3 prior to the 30th day after publication in the Federal
Register. The proposed rule change and Amendments Nos. 1 and 2 thereto
previously have been published for comment and have been available on
NASD's Web site since their filing with the Commission. Amendment No. 3
proposes non-substantive, technical changes to the proposed rule
change, consistent with the current Code, in order to facilitate
approval of the proposed Mediation Code. Accelerated approval of
Amendment No. 3 will allow parties to more quickly utilize the
reorganized and revised Mediation Code. Based on the above, the
Commission finds good cause, consistent with Section 15A(b)(6) and
Section 19(b)(2) of the Act, for approving Amendment No. 3 prior to the
30th day after the date of publication of notice of filing thereof in
the Federal Register.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning Amendment No. 3, including whether it 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-NASD-2004-013 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number SR-NASD-2004-013. The
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 inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing will also be available
for inspection and copying at the principal office of NASD. 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 SR-2004-013 and should be submitted on or
before November 28, 2005.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority, 17 CFR 200.30-3(a)(12).
Jonathan G. Katz,
Secretary.
[FR Doc. E5-6140 Filed 11-4-05; 8:45 am]

BILLING CODE 8010-01-P


723 02:16:10.140 --> 02:16:18.600 Amanda Kohler: There is, you know the if you look at the manifest form the certifications the acknowledgement of receipt is very specific to the person that.

724 02:16:19.080 --> 02:16:28.140 Amanda Kohler: was involved in the preparation of the shipment, for example, so, so we are at this point, you know uncomfortable with the idea of just having some other person who's not even.

725 02:16:28.560 --> 02:16:34.500 Amanda Kohler: Aware of light of the packaging and you know it's not kind of physically near the shipment signing so.

726 02:16:34.920 --> 02:16:44.400 Amanda Kohler: In other words, were uncomfortable just having a site manager sign all the manifests so scenario for kind of brings these two together and has the electronic signature captured in some manner.

727 02:16:44.880 --> 02:16:55.710 Amanda Kohler: By the hazardous waste, companies and then having that information transmitted by the site manager to our system through that unique ID and key.

728 02:17:10.590 --> 02:17:11.670 Tess Fields: Thank you very much, Nick.

729 02:17:12.090 --> 02:17:13.290 Nick Taglianetti: Thank you very much.

730 02:17:19.410 --> 02:17:25.500 Tess Fields: And I would, encourage you again if you'd like to flesh out your thoughts more to submit a written comments or docket.

731 02:17:26.880 --> 02:17:27.510 Tess Fields: um.

732 02:17:28.770 --> 02:17:30.090 Tess Fields: Does anyone else have.

733 02:17:32.880 --> 02:17:38.160 Tess Fields: comments or questions or feedback, based on what we've discussed her these discussion questions.

734 02:18:01.980 --> 02:18:04.980 Tess Fields: we're ready to move on to our Q&A section.

735 02:18:09.120 --> 02:18:17.160 Tess Fields: Okay, so I'll hand it back over to Brian to walk through the various questions that have been put in our Q&A box.

736 02:18:18.540 --> 02:18:21.270 Bryan Groce: Thanks this so we don't have very many.

737 02:18:25.230 --> 02:18:26.700 Bryan Groce: Questions here.

738 02:18:28.230 --> 02:18:33.660 Bryan Groce: So, I'm just going to read through, I just want to remind folks this isn't the only opportunity for.

739 02:18:34.170 --> 02:18:46.590 Bryan Groce: People to comment you can submit your questions or comments to our docket following this meeting you have up to I believe December 30 to do so, so just want to reiterate that point, so the first.

740 02:18:47.610 --> 02:18:58.110 Bryan Groce: At least more of a comment, it says here that slide 50 presumes that Internet works across the nation it on that's not true and parts of the country.

741 02:18:59.400 --> 02:19:04.110 Bryan Groce: they're doing there may be some poor signal connection so not everyone necessarily would have.

742 02:19:06.480 --> 02:19:16.500 Bryan Groce: The access for you manifest us so based on this is a question that that we've been I guess sort of analyzing over the past.

743 02:19:17.790 --> 02:19:30.990 Bryan Groce: few months to a year and based on our IT team's analysis, I believe, and you guys can correct me if I am wrong here that roughly 98 of all generators.

744 02:19:32.190 --> 02:19:35.730 Bryan Groce: That are active RCRA info have.

745 02:19:36.870 --> 02:19:39.450 Bryan Groce: At least some type of Internet connection.

746 02:19:40.740 --> 02:19:51.960 Bryan Groce: And I don't know if, you guys want to explain that further and sort of explain what type they have, sort of a very basic type, not the high end, perhaps, but it's worth noting here.

747 02:19:53.460 --> 02:20:05.160 Stephen Donnelly: yeah so, I'll say this, I think, William did the we this has come up a few times, so we have a couple hundred thousand generators in the United States with EPA I think it's around 250 to 300,000.

748 02:20:05.730 --> 02:20:17.190 Stephen Donnelly: And so, 98% of those are GEO coding and eligible for an analysis of Internet coverage so of those of those 98% that we could.

749 02:20:18.630 --> 02:20:20.610 Stephen Donnelly: figure out where they are that are active.

750 02:20:22.830 --> 02:20:33.360 Stephen Donnelly: hundred percent have at least one business grade broadband so that includes satellite cell LTE offerings and.

751 02:20:34.680 --> 02:20:52.170 Stephen Donnelly: And then 99.9% of those sites that we could figure out where they are active sites where you figure out where they are 99.99% at least one traditional terrestrial broadband so that's a that's as you know sort of consumer.

752 02:20:53.550 --> 02:20:59.490 Stephen Donnelly: files or verizon a business cable modem option so.

753 02:21:00.990 --> 02:21:18.870 Stephen Donnelly: As far as far as far as this analysis will take us the generators, for the most part, are for are essentially they have Internet come now, the question is they, you know, was the manifest once that waste hits a.

754 02:21:20.010 --> 02:21:26.310 Stephen Donnelly: Was that way cicerone the drivers in you know the driver is in the hinterlands and there's no cell coverage so nothing.

755 02:21:27.300 --> 02:21:41.220 Stephen Donnelly: However, about where the ways is being picked up and where it's being where it's being dropped off, we found that they have Internet company you're able to go able to connect now if.

756 02:21:42.720 --> 02:21:48.990 Stephen Donnelly: The I think one of the reasons we're having this discussion and conversation, is that there are a lot of people with Internet coverage that.

757 02:21:49.050 --> 02:22:00.060 Stephen Donnelly: aren't doing electronic benefits I don't think the lack of Internet coverage is what's keeping the electronic numbers for being so low, however, we would like to put to bed, the notion that elect it's.

758 02:22:00.870 --> 02:22:12.720 Stephen Donnelly: it's generators that having Internet access, that is driving down the numbers and that will keep us from pushing this forward so we are we're coming to get you everyone's online all the time.

759 02:22:13.890 --> 02:22:32.850 Amanda Kohler: also add to that you know, in the event that you know online access goes down for a storm, or you know other reason temporarily we'd be interested in thoughts about adopting policy where you collect the signature perhaps at the hazardous waste companies.

760 02:22:33.930 --> 02:22:42.060 Amanda Kohler: side, but as long as you transmit to EPA, you know once access is established, or at least before the next.

761 02:22:43.080 --> 02:22:49.830 Amanda Kohler: Signature point you know would that be okay, and then that kind of that kind of handles a lot of the offline issues we think.

762 02:22:55.380 --> 02:22:56.340 Bryan Groce: Okay I'm.

763 02:22:57.660 --> 02:23:02.940 Bryan Groce: David, could you scroll up to slide 52 please.

764 02:23:05.370 --> 02:23:07.740 Bryan Groce: So, there's a comment that in terms of.

765 02:23:10.290 --> 02:23:10.710 Bryan Groce: Our.

766 02:23:11.850 --> 02:23:16.110 Bryan Groce: characterization of what the regulation says regarding.

767 02:23:18.270 --> 02:23:19.590 Bryan Groce: Maybe it's the next slide down.

768 02:23:21.690 --> 02:23:22.860 Bryan Groce: The word only was added.

769 02:23:24.180 --> 02:23:37.980 Bryan Groce: To the regulation referenced on the slide just want to make this one, to mention that that the commoner is correct and we will correct that slide for our next our next meeting on November 3.

770 02:23:38.400 --> 02:23:44.010 Amanda Kohler: Well, I actually have a thought on that so so correct for the main takeaways that.

771 02:23:44.250 --> 02:23:45.270 Bryan Groce: For the REG yes.

772 02:23:45.960 --> 02:24:03.450 Amanda Kohler: Right, so this is our takeaway so certainly these are you know early stages, and we encourage everyone to submit comments to the docket regarding our early findings on the requirements, but if David if you can flip up to the actual rank language.

773 02:24:05.010 --> 02:24:09.120 Amanda Kohler: I think it's 262 so right here, right here yeah, I think it's this one.

774 02:24:10.320 --> 02:24:13.470 Bryan Groce: It says it's in (a)(2).

775 02:24:13.920 --> 02:24:22.620 Amanda Kohler: Right okay so here's the actual REG language transmitted to the other person by submission to the system in our takeaway slide we said holy this is.

776 02:24:23.280 --> 02:24:35.250 Amanda Kohler: Great that's you know, so we haven't right in the regs that's our interpretation of it now, I think this commoner was you know, pointing out a nuance that we have, we have not covered, which is the hybrid so the hybrid manifests.

777 02:24:36.360 --> 02:24:43.170 Amanda Kohler: The generator science on paper and they're not conducting electronic manifest and so, in that case, if the generators are registered.

778 02:24:44.370 --> 02:24:46.740 Amanda Kohler: You know the TSDFs to send back.

779 02:24:46.740 --> 02:24:59.220 Amanda Kohler: certificate in hard copy to the generator I would say so that's an important nuance however hybrid manifest we have already provisions for those in or regulation, so I.

780 02:25:00.000 --> 02:25:15.090 Amanda Kohler: I applaud the comment because I brought out the REG so thank you for making me go to the regs here but um, but it is in that same section I think 262 24 and so it's already built in, so the So the question here is if we wanted to consider something other than a two.

781 02:25:16.290 --> 02:25:28.530 Amanda Kohler: Would we have to then do another red change  which we could you know that's something that we could consider as a program, but it would be, I think, at this point, early stages, a red change needed for that scenario.

782 02:25:30.480 --> 02:25:33.780 Amanda Kohler: So, I hope I hope that's a broader answer there.

783 02:25:36.210 --> 02:25:44.460 Stephen Donnelly: yeah, there are a wise, that is, a lot of ins and outs of the regs and there's a lot of grading material in the appendix, so we hope we.

784 02:25:45.150 --> 02:25:55.440 Stephen Donnelly: You know, as we go through this there's a lot of we've done a lot of homework but we are by no means shutting the door on any option or any proposal, we want to hear.

785 02:25:56.070 --> 02:26:04.890 Stephen Donnelly: And we want to hear you know, we want to hear stuff that can be defended through the statute of the regs and we don't want to hear anything great well, maybe I want to hear some.

786 02:26:05.340 --> 02:26:13.320 Stephen Donnelly: crazy proposals, but for the most part we we've given the information that we've been using to draw these assumptions are the information.

787 02:26:13.620 --> 02:26:22.980 Stephen Donnelly: That you have access to so we're all no one's hiding the ball on anything there's no secret there's no secret signature guidance, that we have that we're not sharing.

788 02:26:23.940 --> 02:26:31.080 Tess Fields: So, the commenter actually raised their hands to respond so I'm going to unmute them.

789 02:26:32.280 --> 02:26:33.540 Tess Fields: Now please go ahead.

790 02:26:34.650 --> 02:26:35.850 Noa Klein: Good morning, can you guys hear me.

791 02:26:36.540 --> 02:26:37.140 Stephen Donnelly: Yes, Hello.

792 02:26:37.410 --> 02:27:02.100 Noa Klein: Okay, so Hello I'm sorry I kept pressing enter I sent in three things that were really all part of the same thing and the main point that I really wanted to make is that I don't think that 40 CFR section 260 2.24 is imposing any requirement about transmitting.

793 02:27:03.960 --> 02:27:12.660 Noa Klein: A manifest to any party by submitting it to the system it's just saying that where there is an existing requirements somewhere else in the rules.

794 02:27:13.080 --> 02:27:27.240 Noa Klein: For any party to give provide send forward or return a copy of a manifest that that requirement can be met by the manifest being transmitted to that other party by submission to the e-manifest system.

795 02:27:28.950 --> 02:27:39.270 Noa Klein: And I think that that's important because, when you look at Option three I think it's actually it does better compared to.

796 02:27:41.100 --> 02:27:45.060 Noa Klein: The current regulations, then it's made out to look.

797 02:27:46.350 --> 02:27:52.290 Noa Klein: I'm not trying to endorse that option I'm just saying that it's extremely important.

798 02:27:53.370 --> 02:27:54.570 Noa Klein: Not to.

799 02:27:56.250 --> 02:28:08.220 Noa Klein: think that there's something required that's not really required if you're evaluating whether you have to make new rules as an important part of how good is this option or not, does that make sense.

800 02:28:09.000 --> 02:28:27.270 Amanda Kohler: yeah, absolutely and appreciate your thoughts on this, you know I just wrote reiterate yeah, this is a user early times for these concepts and so this is our early leaning on how the requirements would fit so we appreciate, you know different perspectives and no I hope you.

801 02:28:29.160 --> 02:28:38.100 Amanda Kohler: You know plan on submitting written comments, because I think those will be really helpful to consider in determining what we actually bring back to the Advisory Board on our requirements here.

802 02:28:39.480 --> 02:28:47.490 Noa Klein: yeah, I can definitely submit the same thing as a written comment if that's helpful for you guys and you know I always have opinions, so thank you for all your word.

803 02:28:47.640 --> 02:28:48.300 Amanda Kohler: Thank you.

804 02:28:49.410 --> 02:28:49.890 Bryan Groce: know.

805 02:28:54.120 --> 02:28:54.750 Bryan Groce: Okay, so.

806 02:28:56.220 --> 02:28:58.830 Bryan Groce: This is more of a comment, I guess, it is a question, but.

807 02:29:01.050 --> 02:29:04.950 Bryan Groce: The person that the individuals asking is, is there a way to download these documents, slides.

808 02:29:06.210 --> 02:29:13.770 Bryan Groce: That we presented here today as we mentioned earlier that the presentation slides are available in the docket and.

809 02:29:14.790 --> 02:29:24.000 Bryan Groce: I think in the following slides will have a summary and in terms of what the docket number is and where you can go to get the slide presentations and where you can submit your comments.

810 02:29:24.960 --> 02:29:38.310 Stephen Donnelly: gather the docket as well as our github site, as we have the stuff going up there as well, so the docket will have everything, including the video that we shared earlier, so the keep your eyes on the docket.

811 02:29:40.260 --> 02:29:41.310 lot of fun stuff going on there.

812 02:29:42.570 --> 02:29:42.990 Bryan Groce: Thanks. the.

813 02:29:44.250 --> 02:29:53.430 Bryan Groce: next question is the quick sign option considered a valid and  cost effective signature and you know, based on the.

814 02:29:54.990 --> 02:30:01.980 Bryan Groce: Current adoption rate I guess the answer at this point is, we just don't know at this time, if that's perhaps something.

815 02:30:02.430 --> 02:30:21.060 Bryan Groce: that's certainly it's valid in our in our estimation, but cost effective that's something that I guess requires further evaluation and not sure if the current central methods are prohibiting individuals from to sending any manifest but that's something we certainly have to.

816 02:30:22.290 --> 02:30:23.190 Bryan Groce: evaluate further.

817 02:30:28.800 --> 02:30:30.720 Bryan Groce: Okay let's see here so.

818 02:30:32.370 --> 02:30:33.420 Bryan Groce: The question.

819 02:30:34.710 --> 02:30:43.380 Bryan Groce: Can the signature process be similar to system-to- systems UPS or FedEx or retail stores developed that seemed to be a robust system.

820 02:30:45.300 --> 02:30:50.280 Bryan Groce: thanks for the comment and that's again that's something that we certainly can pursue.

821 02:30:52.740 --> 02:31:01.440 Bryan Groce: Alternative electronic formats and electronic signatures is something we certainly can evaluate and see if that's a viable option for your signatures.

822 02:31:02.130 --> 02:31:17.940 Amanda Kohler: yeah, similar to that I think scenario for and maybe even three you know what an individual company may choose to adopt, whether you know they're in the in-house system that they have now, or if they want to adopt something like ups or another signature.

823 02:31:20.220 --> 02:31:26.040 Amanda Kohler: Application software that's off the shelf that would all be part of scenario, three and four, I think right Steve.

824 02:31:33.210 --> 02:31:50.040 Bryan Groce: I think that's for the most part that's all I have in the Q&A box madness misspoke previously it's we didn't use the chat the chat is not activated for the question session but we're using the Q&A box, so wanted to be clear on that.

825 02:31:51.870 --> 02:31:52.260 Thanks.

826 02:32:24.930 --> 02:32:25.920 Tess Fields: So, I think.

827 02:32:27.000 --> 02:32:39.060 Tess Fields: Our next session or section is open discussion next slide David just about a final call for if anybody has any thoughts on.

828 02:32:40.980 --> 02:32:45.660 Tess Fields: Anything with presented today or comments or suggestions on things that they think.

829 02:32:47.490 --> 02:32:55.020 Tess Fields: You know, might be helpful or think that we should consider, so this is just a final opening of the floor if anybody would like to.

830 02:32:56.340 --> 02:32:56.970 Tess Fields: raise their hand.

831 02:33:05.730 --> 02:33:11.520 Tess Fields: No just wait two minutes in silence, if necessary, but then next slide will be about.

832 02:33:12.720 --> 02:33:15.120 Tess Fields: Submitting things to the docket and how to contact us.

833 02:34:32.790 --> 02:34:37.650 Tess Fields: Oh, David has raised his hand, so please feel free to unmute yourself David.

834 02:34:40.020 --> 02:34:40.410 David Comen: kind of.

835 02:34:42.420 --> 02:34:48.960 David Comen: kind of have a question on EPA's  thoughts of called targets for who.

836 02:34:50.160 --> 02:35:13.440 David Comen: Who in the regulated world or third party with do some of these options I work a lot with generators transporters and a little bit with TSDFs and looking at these the ability of a generator to implement I think any of these, as is almost homeless, Neil.

837 02:35:14.490 --> 02:35:18.210 David Comen: Maybe some transporters, but again, not very many of them.

838 02:35:19.350 --> 02:35:27.690 David Comen: And they're, these are the folks that are doing, most of the signatures, so I guess kind of looking for maybe some feedback on.

839 02:35:28.890 --> 02:35:35.910 David Comen: Who out here in a called an electron world would be designing and implementing these systems.

840 02:35:42.450 --> 02:35:49.500 Tess Fields: Thank you for that comment and question. Steve or Amanda or anyone on the team to address that.

841 02:35:56.610 --> 02:35:59.970 Stephen Donnelly: yeah, Thank you, thank you very much for that question, and that is a.

842 02:36:00.570 --> 02:36:12.810 Stephen Donnelly: that's one of the sort of the main considerations, we have when people you know mentioned, you know you're we're not just making a system just for FedEx or the post office we're making something for.

843 02:36:13.890 --> 02:36:19.200 Stephen Donnelly: 10 thousand of different companies and thousands of different individuals to use and.

844 02:36:20.760 --> 02:36:30.120 Stephen Donnelly: that's the that's the that's one of the primary drivers for why we're having this conversation, and you know how we how we built our system is essentially you know we have.

845 02:36:31.470 --> 02:36:37.050 Stephen Donnelly: we're sort of agnostic when it comes to how you're you know what you're using to send us the data.

846 02:36:38.550 --> 02:36:54.120 Stephen Donnelly: If the question is your and we have our structured data in the API's now the next step is how you're going to be sending us the how you could potentially send us the signature information because we understand we're not we're not so.

847 02:36:55.230 --> 02:37:07.260 Stephen Donnelly: or not so naive as a think that well, we could we could you know, having everybody operating the system, as is going to get us to 100% electronic manifest.

848 02:37:07.680 --> 02:37:17.670 Stephen Donnelly: So, what we're looking at now, especially with the options, you know, three and four is, as we have 85% of those 6 million manifests that come through.

849 02:37:18.390 --> 02:37:32.370 Stephen Donnelly: Through  data services, what can we do to move it along so those  manifest coming in through data services are also including signature information that meets that.

850 02:37:33.690 --> 02:37:35.070 Stephen Donnelly: meets those are the five.

851 02:37:36.450 --> 02:37:38.130 Stephen Donnelly: The five the five rules.

852 02:37:39.150 --> 02:37:48.270 Stephen Donnelly: And also, is cost effective impractical for the industry system so that's what we're that's what we're looking on in moving ahead and I understand there's a lot of.

853 02:37:48.720 --> 02:37:58.500 Stephen Donnelly: there's a lot of questions about you know, especially when it comes to the transporters how to how to bring those in and that's a that's an issue and we will you know.

854 02:37:59.340 --> 02:38:06.630 Stephen Donnelly: we're three years or three years into this and we're going to be around for a lot longer so that's something that we're going to move towards so we don't really have an answer.

855 02:38:07.290 --> 02:38:15.930 Stephen Donnelly: Other than our application is agnostic to it comes with how the data is coming what we want to do is sort of continue to.

856 02:38:16.800 --> 02:38:29.910 Stephen Donnelly: use that successful base accessible format we've got what we got 85% of that data coming in through services to bring in the signature information for that generator and transport and we don't think it's going to be.

857 02:38:30.990 --> 02:38:35.580 Stephen Donnelly: we're not exactly moving things up and you know, this is not impossible it's good it is.

858 02:38:36.630 --> 02:38:45.210 Stephen Donnelly: It is slow, it is it slow and you know sort of plotting work, but that is what we're here for.

859 02:39:01.680 --> 02:39:11.190 Stephen Donnelly: And then yeah so, I have a throwback a question to you, David is that um what, in your experience is.

860 02:39:13.020 --> 02:39:27.720 Stephen Donnelly: Leading you to believe that the generator and transporter ability to implement these options would not exist, particularly option options, where they're sending up knowing the say the name the name of a driver.

861 02:39:30.570 --> 02:39:31.950 David Comen: Well, I guess, and.

862 02:39:33.300 --> 02:39:49.110 David Comen: I have to confess I am completely out of my league when we're talking about the electronic aspects of this so that may be part of my limitation, but I'm dealing with I'm a truck driver sitting at the generator site.

863 02:39:50.970 --> 02:39:51.840 David Comen: And I've got a.

864 02:39:52.950 --> 02:39:59.460 David Comen: I've got a phone in my hand and I'm trying to figure out how to get to where I need to get to make a signature.

865 02:40:00.510 --> 02:40:12.030 David Comen: And drivers are in short supply, now, and I have somebody spends five minutes doing that and they throw the phone against the wall and go to work for another company then whole hazardous waste.

866 02:40:13.140 --> 02:40:22.710 David Comen: So I've got a little bit of a you know how do I facilitate for that individual and I guess part of my question and just my understanding is.

867 02:40:24.060 --> 02:40:34.530 David Comen: is, for example, if you have a transporter with 100 drivers do you think that they would have the resources to create an interface system.

868 02:40:35.910 --> 02:40:40.530 David Comen: Where their drivers to be able to do something easier, are you kind of looking for.

869 02:40:41.700 --> 02:40:55.350 David Comen: Third party to create a system that is funded by the menu by people that use it or funded by EPA, or you know kind of where does that that go.

870 02:40:56.370 --> 02:41:10.830 David Comen: tell you what my mental picture of something that works is a handheld device to just like what ups and FedEx use when they walk up to my door and they scan a package and an instruction to do something, and they do it and it's.

871 02:41:12.270 --> 02:41:13.590 David Comen: it's done very quickly.

872 02:41:14.880 --> 02:41:22.380 David Comen: So, if some kind of barcode or tracking number, which obviously we've got manifest numbers available is unique tracking number.

873 02:41:22.950 --> 02:41:30.720 David Comen: So, I'm kind of looking at something that says the driver walks in and gets handed a printed copy of the manifest that in each store is.

874 02:41:31.560 --> 02:41:43.500 David Comen: The shipping paper and he scans a barcode or a qr code up in the corner and it says there should be a tanker truck with 5000 gallons of ketone in it, and if this is right.

875 02:41:44.700 --> 02:41:48.180 David Comen: punch here and you've signed this is the transporter.

876 02:41:55.110 --> 02:41:55.410 David Comen: And that's.

877 02:41:56.160 --> 02:41:58.950 Stephen Donnelly: A that's very that is really very helpful.

878 02:42:02.700 --> 02:42:09.150 Amanda Kohler: And again, I'll point out, I don't think that's different necessarily from scenario for in that the.

879 02:42:09.570 --> 02:42:13.380 Amanda Kohler: companies can decide how they want to capture electronic signatures.

880 02:42:13.980 --> 02:42:18.960 Amanda Kohler: And then the trends middle would just be through the state on site ID manager site manager sorry.

881 02:42:20.700 --> 02:42:36.630 Amanda Kohler: So, it's um there's a lot of different ways to capture electronic signatures and that's why we took the time with  tests here to describe the hallmarks of the legal and enforceable electronic signatures, because a lot of different formats can count as electronic signatures.

882 02:42:45.150 --> 02:42:54.510 Amanda Kohler: And so, I think it would be helpful to is if there is something that we are not comfortable entertaining That would be good to know from the users from the stakeholders and so.

883 02:42:55.680 --> 02:42:57.600 Amanda Kohler: You know, certainly in your written comments.

884 02:42:59.550 --> 02:43:01.800 Amanda Kohler: This would be a good issue to discuss.

885 02:43:26.910 --> 02:43:27.060 well.

886 02:43:37.530 --> 02:43:41.730 Tess Fields: Okay Thank you everyone who has given us feedback.

887 02:43:42.870 --> 02:43:44.490 Tess Fields: Does anyone else have.

888 02:43:47.340 --> 02:43:51.420 Tess Fields: remaining questions or comments that they would like for us.

889 02:43:52.710 --> 02:43:58.620 Tess Fields: And if not, we'll move on to our how to stay involved after this meeting slide.

890 02:44:08.400 --> 02:44:10.080 Tess Fields: hi David, I think you can take it away.

891 02:44:17.880 --> 02:44:29.730 Stephen Donnelly: Alright, thanks Tess alright, so this remind you that the Federal Register notice is open and available for public comment until December 30, 2021, so.

892 02:44:30.870 --> 02:44:31.320 Stephen Donnelly: Now as.

893 02:44:32.340 --> 02:44:39.690 Stephen Donnelly: we've kept us over for a while, because we want your feedback, we want your comments and we also have are supplementary materials.

894 02:44:40.560 --> 02:44:48.930 Stephen Donnelly: They will be available and regulations.gov under docket number 2021 dash 0608.

895 02:44:49.440 --> 02:44:58.080 Stephen Donnelly: It takes a few days for materials to go from us requesting the be posted the docket to when they actually get in the docket so there might be a lifetime.

896 02:44:58.410 --> 02:45:06.330 Stephen Donnelly: Especially as we get the meeting recording and we get the transcript uploaded but then we looked at having actual material was putting the.

897 02:45:06.990 --> 02:45:16.590 Stephen Donnelly: via the example json uploaded as soon as possible and just remind you that we're going to be using this information from today's public meeting to inform.

898 02:45:17.550 --> 02:45:34.200 Stephen Donnelly: options for consideration by the manifest Advisory Board, so you if you if you want to participate in that please stay tuned and stay in contact with the manifest and we will have information, other than we plan on having a meeting in 2022 and we do encourage you to.

899 02:45:35.550 --> 02:45:38.640 Stephen Donnelly: Stay can't stay in contact, we have our next slide with.

900 02:45:39.720 --> 02:45:40.020 Stephen Donnelly: me.

901 02:45:41.040 --> 02:45:41.550 Stephen Donnelly: not there yet.

902 02:45:43.110 --> 02:45:59.700 Stephen Donnelly: right here yeah perfect and we also have ways to stay, we have a low volume listservs for program updates and developers, we have our website that is updated a lot, especially our FAQs and we also have our github repository where we put all of our software development.

903 02:46:02.430 --> 02:46:18.330 Stephen Donnelly: materials, as well as what up top help desk and then we didn't talk about generator read registration or and user registration, but that is always on our mind, so if you are a generator and you are not registered or you know, a generator that registered.

904 02:46:19.530 --> 02:46:29.850 Stephen Donnelly: Please let them know we have information on our website if they get stuck we have a help desk that can help them find their site and request site manager access or whatever access they'd like so please.

905 02:46:30.540 --> 02:46:36.660 Stephen Donnelly: If you are a generator and you're not registered please register and let this what this.

906 02:46:37.620 --> 02:46:42.450 Stephen Donnelly: What the world know that the manifest program once generators and transports register so.

907 02:46:42.750 --> 02:46:55.260 Stephen Donnelly: We can get some more electronic manifesting get you out into the fold for a lot of other requests dumpling biennial report or updating your site ID form there's a lot of great stuff to do once you're inside of the application.

908 02:46:56.940 --> 02:47:03.930 Stephen Donnelly: Alright, so I want to say thank you all for attending members of the public guards generators and transporters or brokers overseeing facilities.

909 02:47:04.620 --> 02:47:12.300 Stephen Donnelly: Members of academia other stakeholders, for the EPA and states, and I want to give a big thank you to the EPA manifest team.

910 02:47:12.660 --> 02:47:21.240 Stephen Donnelly: Particularly for marshaling this and put this all together a big thanks to a medical or Thank you Amanda thanks to our new members of the team and, thanks to our.

911 02:47:21.540 --> 02:47:35.070 Stephen Donnelly: Our seasoned veterans of the team, and we will end this webinar and we will be in touch with you all very soon, we have another meeting next week and have a great day and a safe and.

912 02:47:36.330 --> 02:47:37.440 Stephen Donnelly: happy Wednesday.


(iii) If you elect to monitor the inlet water feed line for a once-
through heat exchange system as provided in paragraph (a)(2)(ii) of
this section, you must monitor the inlet water feed line at least
quarterly.
    (b) A heat exchange system is exempt from the monitoring
requirements in paragraph (a) of this section if it meets any one of
the criteria in paragraphs (b)(1) through (3) of this section.
    (1) All heat exchangers that are in regulated material service
within the heat exchange system operate with the minimum pressure on
the cooling water side at least 35 kilopascals greater than the maximum
pressure on the process side.
    (2) The heat exchange system does not contain any heat exchangers
that are in regulated material service, as defined in this subpart or
as defined in the referencing subpart, as applicable.
    (3) The heat exchange system has a maximum cooling water flow rate
of 10 gallons per minute or less.
    (c) Unless otherwise specified by the referencing subpart, the leak
action level is either a total strippable hydrocarbon concentration (as
methane) in the stripping gas of 3.1 ppmv or a total strippable
hydrocarbon concentration in the cooling water of 40 ppbw. A leak is
defined as described in paragraph (c)(1) or (c)(2) of this section, as
applicable.
    (1) For once-through heat exchange systems for which you monitor
the inlet water feed as described in paragraph (a)(2)(ii) of this
section, a leak is detected if the difference in the measurement value
of the sample taken from a location specified in paragraph (a)(2)(i) of
this section and the measurement value of the corresponding sample
taken from the location specified in paragraph (a)(2)(ii) of this
section equals or exceeds the leak action level.
    (2) For all other heat exchange systems, a leak is detected if a
measurement value taken according to the requirements in paragraph (a)
of this section equals or exceeds the leak action level.
    (d) If a leak is detected pursuant to the monitoring provisions of
paragraph (a), you must repair the leak to reduce the measured
concentration to below the applicable action level as soon as
practicable, but no later than 45 days after identifying the leak,
except as specified in paragraphs (e) and (f) of this section. Repair
includes re-monitoring as specified in paragraph (a) of this section to
verify that the measured concentration is below the applicable action
level. Actions that you can take to achieve repair include, but are not
limited to:
    (1) Physical modifications to the leaking heat exchanger, such as
welding the leak or replacing a tube;
    (2) Blocking the leaking tube within the heat exchanger;
    (3) Changing the pressure so that water flows into the process
fluid;
    (4) Replacing the heat exchanger or heat exchanger bundle; or
    (5) Isolating, bypassing, or otherwise removing the leaking heat
exchanger from service until it is otherwise repaired.
    (e) If you detect a leak when monitoring a cooling tower return
line or heat exchanger exit line under paragraph (a) of this section,
you may conduct additional monitoring following the requirements in
paragraph (a) of this section to further isolate each heat exchanger or
group of heat exchangers in regulated material service within the heat
exchange system for which the leak was detected. If you do not detect
any leaks when conducting additional monitoring for each heat exchanger
or group of heat exchangers in regulated material service, the heat
exchange system is excluded from the repair requirements in paragraph
(d) of this section.
    (f) Unless otherwise specified by the referencing subpart, the
delay of repair action level is defined as either a total strippable
hydrocarbon concentration (as methane) in the stripping gas of 62 ppmv
or a total strippable hydrocarbon concentration in the cooling water of
800 ppbw. If the repair action level is exceeded as specified under the
referencing subpart or this paragraph, and unless specified otherwise
in the referencing subpart, you may delay the repair of a leaking heat
exchanger when

one of the conditions in paragraphs (f)(1) or (f)(2) of this section is
met. You must determine if a delay of repair is necessary as soon as
practicable, but no later than 45 days after first identifying the
leak.
    (1) If the repair is technically infeasible without a shutdown and
the total strippable hydrocarbon concentration is initially and remains
less than the delay of repair action level for all monitoring periods
during the delay of repair, you may delay repair until the next
scheduled shutdown of the heat exchange system. If, during subsequent
monitoring, the total strippable hydrocarbon concentration is equal to
or greater than the delay of repair action level, you must repair the
leak within 30 days of the monitoring event in which the total
strippable hydrocarbon was equal to or exceeded the delay of repair
action level.
    (2) If the necessary equipment, parts, or personnel are not
available and the total strippable hydrocarbon concentration (as
methane) is initially and remains less than the delay of repair action
level for all monitoring periods during the delay of repair, you may
delay the repair for a maximum of 120 calendar days from the day the
leak was first identified. You must demonstrate that the necessary
equipment, parts, or personnel were not available. If, during
subsequent monthly monitoring, the total strippable hydrocarbon
concentration is equal to or greater than the delay of repair action
level, you must repair the leak within 30 days of the monitoring event
in which the leak was equal to or exceeded the total strippable
hydrocarbon delay of repair action level.
    (g) Unless otherwise specified in the referencing subpart, to delay
the repair under paragraph (f) of this section, you must record the
information in paragraphs (g)(1) through (4) of this section.
    (1) The reason(s) for delaying repair.
    (2) A schedule for completing the repair as soon as practical.
    (3) The date and concentration of the leak as first identified and
the results of all subsequent monitoring events during the delay of
repair.
    (4) An estimate of the potential emissions from the leaking heat
exchange system following the procedures in paragraphs (f)(4)(i) and
(ii) of this section.
    (i) Determine the total strippable hydrocarbon concentration in the
cooling water, in ppbw, using equation 7-1 from ``Air Stripping Method
(Modified El Paso Method) for Determination of Volatile Organic
Compound Emissions from Water Sources,'' Revision Number One, dated
January 2003, Sampling Procedures Manual, Appendix P: Cooling Tower
Monitoring, prepared by Texas Commission on Environmental Quality,
January 31, 2003 (incorporated by reference--see Sec.  65.265).
    (ii) Calculate the emissions for the leaking heat exchange system
by multiplying the hydrocarbon concentration in the cooling water,
ppbw, by the flow rate of the cooling water at the selected monitoring
location and by the expected duration of the delay. The flow rate may
be based on direct measurement, pump curves, heat balance calculations
or other engineering methods.

Notifications, Reports and Records

Sec.  65.615  What notifications must I submit and when?

    If the referencing subpart requires that a notification of
compliance status be filed, then, at a minimum, you must include the
information specified in paragraphs (a) and (b) of this section in the
notification of compliance status. The notification of compliance
status shall be transmitted to the EPA's Central Data Exchange by using
either electronic reporting software available from the EPA or in an
electronic file format specified by the EPA. The notification of
compliance status shall also be submitted to the delegated authority in
the form and/or format specified by the delegated authority. The
notification of compliance status must be signed by the responsible
official who shall certify its accuracy, attesting to whether the
source has complied with the relevant standard.
    (a) The information specified in the referencing subpart.
    (b) Identification of the heat exchange systems that are subject to
the requirements of the referencing subpart.

Sec.  65.620  What reports must I submit and when?

    Unless otherwise specified in the referencing subpart, you must
report the information specified in paragraphs (a) through (f) of this
section, as applicable, in the periodic report specified in the
referencing subpart.
    (a) The number of heat exchange systems in regulated material
service.
    (b) The number of heat exchange systems in regulated material
service found to be leaking.
    (c) A summary of the monitoring data that indicate a leak,
including the number of leaks determined to be equal to or greater than
the leak definitions specified in the referencing subpart.
    (d) If applicable, the date a leak was identified, the date the
source of the leak was identified and the date of repair.
    (e) If applicable, a summary of each delayed repair, including the
original date and reason for the delay and the date of repair, if
repaired during the reporting period.
    (f) If applicable, an estimate of total strippable hydrocarbon
emissions for each delayed repair over the reporting period.

Sec.  65.625  What records must I keep?

    Unless otherwise specified in the referencing subpart, for a heat
exchange system subject to the requirements of this subpart, you must
keep the records specified in paragraphs (a) through (f) of this
section and you must retain these records for 5 years.
    (a) Identification of all heat exchangers at the facility and the
measured or estimated average annual regulated material concentration
of process fluid or intervening cooling fluid processed in each heat
exchanger.
    (b) Identification of all heat exchange systems that are in
regulated material service. For each heat exchange system that is
subject to this subpart, you must include identification of all heat
exchangers within each heat exchange system, identification of the
individual heat exchangers in regulated material service within each
heat exchange system and for closed-loop recirculation systems, the
cooling tower included in each heat exchange system.
    (c) Identification of all heat exchange systems that are exempt
from the monitoring requirements according to the provisions in Sec.
65.610(b) and the provision under which the heat exchange system is
exempt.
    (d) Results of the following monitoring data for each monitoring
event:
    (1) Date/time of event.
    (2) Heat exchange exit line flow or cooling tower return line flow
at the sampling location, gallons/minute.
    (3) Monitoring method employed.
    (4) If the ``Air Stripping Method (Modified El Paso Method) for
Determination of Volatile Organic Compound Emissions from Water
Sources'' Revision Number One, dated January 2003, Sampling Procedures
Manual, Appendix P: Cooling Tower Monitoring, prepared by Texas
Commission on Environmental Quality, January 31, 2003 (incorporated by
reference--see Sec.  65.265) is used according to Sec.
65.610(a)(3)(i):
    (i) Barometric pressure.
    (ii) El Paso air stripping apparatus water flow milliliter/minute
(ml/min) and air flow, ml/min, and air temperature, [deg]Celsius.

    (iii) FID reading (ppmv).
    (iv) Length of sampling period.
    (v) Sample volume.
    (vi) Calibration information identified in Section 5.4.2 of the
``Air Stripping Method (Modified El Paso Method) for Determination of
Volatile Organic Compound Emissions from Water Sources'' Revision
Number One, dated January 2003, Sampling Procedures Manual, Appendix P:
Cooling Tower Monitoring, prepared by Texas Commission on Environmental
Quality, January 31, 2003 (incorporated by reference--see Sec.
65.265).
    (5) If SW-846 Methods 5030B and 8260C or ASTM Method D5790-95 is
used according to Sec.  65.610(a)(3)(ii):
    (i) The type of detector used.
    (ii) The list of target analytes.
    (iii) The measured cooling water concentration for each of target
analyte (ppbw).
    (iv) The method detection limit for each analyte.
    (v) Calibration and surrogate recovery information identified in
the corresponding method.
    (6) If an alternative method is used according to Sec.
65.610(a)(3)(iii):
    (i) Specific citation for the test method used.
    (ii) Analysis technique.
    (iii) The list of target analytes.
    (iv) The measured cooling water concentration for each of target
analyte (ppbw).
    (v) Calibration and surrogate recovery information identified in
test method used.
    (vi) Other records regarding the monitoring method or results as
specified in the referencing subpart.
    (e) The date when a leak was identified and the date when the heat
exchanger was repaired or taken out of service.
    (f) If a repair is delayed, the reason for the delay, the schedule
for completing the repair and the estimate of potential emissions for
the delay of repair.

Other Requirements and Information

Sec.  65.630  What parts of the General Provisions apply to me?

    The General Provisions applicable to the referencing subpart apply
to this subpart as specified in the referencing subpart. The provisions
of subpart H of this part (General Provisions--Uniform Standards) also
apply to this subpart. The provisions of subpart A of this part
(General Provisions--Consolidated Federal Air Rule) do not apply to
this subpart.

Sec.  65.635  Who implements and enforces this subpart?

    (a) This subpart can be implemented and enforced by the U.S.
Environmental Protection Agency (EPA). If the EPA Administrator has
delegated authority to a state, local or tribal agency, then that
agency has the authority to implement and enforce this subpart. Contact
the applicable EPA Regional Office to find out if this subpart is
delegated to a state, local or tribal agency.
    (b) In delegating implementation and enforcement authority of this
subpart to a state, local or tribal agency under 40 CFR part 63,
subpart E, the authorities contained in paragraphs (b)(1) through (4)
of this section are retained by the EPA Administrator and are not
transferred to the state, local or tribal agency.
    (1) Approval of alternatives to the requirements in Sec.  65.610,
under Sec.  63.6(g).
    (2) Approval of major changes to test methods under Sec.
63.7(e)(2)(ii) and (f) and as defined in Sec.  63.90 and as required in
this subpart.
    (3) Approval of major changes to monitoring under Sec.  63.8(f) and
as defined in Sec.  63.90 and as required in this subpart.
    (4) Approval of major changes to recordkeeping and reporting under
Sec.  63.10(f) and as defined in Sec.  63.90 and as required in this
subpart.

Sec.  65.640  What definitions apply to this subpart?

    All terms used in this subpart shall have the meaning given them in
the Clean Air Act and in this section.
    Cooling tower means a heat removal device used to remove the heat
absorbed in circulating cooling water systems by transferring the heat
to the atmosphere using natural or mechanical draft.
    Cooling tower return line means the main water trunk lines at the
inlet to the cooling tower before exposure to the atmosphere.
    Heat exchange system means a device or collection of devices used
to transfer heat from process fluids to water without intentional
direct contact of the process fluid with the water (i.e., non-contact
heat exchanger) and to transport and/or cool the water in a closed-loop
recirculation system (cooling tower system) or a once-through system
(e.g., river or pond water). For closed-loop recirculation systems, the
heat exchange system consists of a cooling tower, all heat exchangers
that are serviced by that cooling tower and all water lines to and from
the heat exchanger(s). For once-through systems, the heat exchange
system consists of one or more heat exchangers servicing an individual
process unit and all water lines to and from the heat exchanger(s).
Intentional direct contact with process fluids results in the formation
of a wastewater.
    Heat exchanger exit line means the cooling water line from the exit
of one or more heat exchangers (where cooling water leaves the heat
exchangers) to either the entrance of the cooling tower return line or
prior to exposure to the atmosphere or mixing with non-cooling water
streams, in, as an example, a once-through cooling system, whichever
occurs first.
    In regulated material service means, unless specified otherwise in
the referencing subpart, a heat exchanger that either contains or
contacts a fluid (liquid or gas) that is at least 5 percent by weight
of regulated material (as defined in the referencing subpart) as
determined according to the provisions of Sec.  65.270 of this part.

[FR Doc. 2011-31530 Filed 1-5-12; 8:45 am]
BILLING CODE 6560-50-P