0.0

                                                                              0

                                                                             $0

Underground Natural Gas Storage reporters

                                                                            0.0

                                                                              0

                                                                             $0

LNG Import and Export Equipment reporters

                                                                            0.0

                                                                              0

                                                                             $0

Natural Gas Distribution reporters

                                                                            0.0

                                                                              0

                                                                             $0

LNG Storage reporters

                                                                            0.0

                                                                              0

                                                                             $0

Equipment Leak surveys--infrared laser beam illuminated instrument [57]

Onshore Natural Gas Processing reporters

                                                                            0.0

                                                                              0

                                                                             $0

Onshore Natural Gas Transmission Compression reporters

                                                                            0.0

                                                                              0

                                                                             $0

Underground Natural Gas Storage reporters

                                                                            0.0

                                                                              0

                                                                             $0

LNG Import and Export Equipment reporters

                                                                            0.0

                                                                              0

                                                                             $0

Natural Gas Distribution reporters

                                                                            0.0

                                                                              0

                                                                             $0

LNG Storage reporters

                                                                            0.0

                                                                              0

                                                                             $0

Equipment Leak surveys--optical gas imaging instrument [57]

Onshore Natural Gas Processing reporters

                                                                            0.0

                                                                              0

                                                                             $0

Onshore Natural Gas Transmission Compression reporters

                                                                            0.0

                                                                              0

                                                                             $0

Underground Natural Gas Storage reporters

                                                                            0.0

                                                                              0

                                                                             $0

LNG Import and Export Equipment reporters

                                                                            0.0

                                                                              0

                                                                             $0

Natural Gas Distribution reporters

                                                                            0.0

                                                                              0

                                                                             $0

LNG Storage reporters

                                                                            0.0

                                                                              0

                                                                             $0

Acid gas removal units, glycol dehydrators or storage tanks--simulation software [77]

Onshore Natural Gas Processing reporters

                                                                            1.0

                                                                            270

                                                                        $32,925

Onshore Petroleum and Natural Gas Production existing reporters

                                                                            1.0

                                                                            289

                                                                        $35,242

Onshore Petroleum and Natural Gas Production new reporters

                                                                            1.0

                                                                             50

                                                                         $6,097

Onshore Petroleum and Natural Gas Gathering and Boosting reporters

                                                                            1.0

                                                                            200

                                                                        $24,389

Transmission storage tanks--flow meter

Onshore Natural Gas Transmission Compression reporters [7][4,][7][5]

                                                                            1.0

                                                                            250

                                                                       $146,334

Transmission storage tanks--acoustic leak detection device

Onshore Natural Gas Transmission Compression reporters [57]

                                                                            0.0

                                                                              0

                                                                             $0

Transmission storage tanks--optical gas imaging instrument

Onshore Natural Gas Transmission Compression reporters [57]

                                                                            0.0

                                                                              0

                                                                             $0

Transmission storage tanks--high volume sampler

Onshore Natural Gas Transmission Compression reporters [57]

                                                                            0.0

                                                                              0

                                                                             $0

Transmission storage tanks--calibrated bag

Onshore Natural Gas Transmission Compression reporters [57]

                                                                            0.0

                                                                              0

                                                                             $0

Gas well completions and workovers with hydraulic fracturing--flow meter

Onshore Petroleum and Natural Gas Production existing reporters [57]

                                                                            0.0

                                                                              0

                                                                             $0

Oil well completions and workovers with hydraulic fracturing--flow meter

Onshore Petroleum and Natural Gas Production existing reporters [7][4][,7][5]

                                                                            1.0

                                                                            246

                                                                       $143,993

Onshore Petroleum and Natural Gas Production new reporters [7][4,75]

                                                                            1.0

                                                                             50

                                                                        $29,267

Well venting for liquids unloading--flow meter

Onshore Petroleum and Natural Gas Production existing reporters [57]

                                                                            0.0

                                                                              0

                                                                             $0

Onshore Petroleum and Natural Gas Production new reporters [57]

                                                                            0.0

                                                                              0

                                                                             $0

                                 YEAR 2 COSTS

TOTAL ANNUAL LABOR BURDEN AND COST
                                                                     219,489.0
                                                                       3,115.7
                                                                       8,133.7
                                                                       4,066.9
                                                                    $23,428,327

                                                                     234,805.3

TOTAL ANNUALIZED CAPITAL COST

                                                                     $1,255,281
TOTAL ANNUAL LABOR COST

                                                                    $23,428,327
TOTAL ANNUAL O&M COSTS

                                                                     $7,453,100
TOTAL ANNUAL COSTS (Labor, O&M, and annualized capital)

                                                                    $32,136,708

Appendix E-3. Detailed Unit Burden and Costs for Petroleum and Natural Gas Systems (Subpart W) -- Year 3
                                    Year 3

                                                      (A)  Hours per Occurrence
                                                  (B)  Occurrences/ Respondent/
                                                                           Year
                                                   (C)  Hours/ Respondent/Year
                                                                        (A x B)
                                                             (D)  Respondents/
                                                                           Year
                                                           (E)  Engineer Hours/
                                                                          Year
                                                                        (C x D)
                                                              Technician Hours/
                                                                           Year
                                                          Middle Manager Hours/
                                                                           Year
                                                      (F) Senior Manager Hours/
                                                                           Year
                                                                (H)  Cost/ Year
1. APPLICATIONS (Not Applicable)

2. SURVEY AND STUDIES (Not Applicable)

3.  ACQUISITION, INSTALLATION, AND UTILIZATION OF TECHNOLOGY AND SYSTEMS

4. REPORT REQUIREMENTS

A1. Read Rule, Instructions, Guidance Documents for Subpart W

Onshore Natural Gas Processing reporters [1,2]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                            470
                                                                       2,350.0
                                                                           -
                                                                         235.0
                                                                         117.5
                                                                       $276,260

Onshore Natural Gas Transmission Compression reporters [1,2]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                            488
                                                                       2,440.0
                                                                           -
                                                                         244.0
                                                                         122.0
                                                                       $286,840

Underground Natural Gas Storage reporters [1,2]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                             50
                                                                         250.0
                                                                           -
                                                                          25.0
                                                                          12.5
                                                                        $29,389

LNG Import and Export Equipment reporters [1,2]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                              7
                                                                          35.0
                                                                           -
                                                                           3.5
                                                                           1.8
                                                                         $4,115

Onshore Petroleum and Natural Gas Production existing reporters [1,2]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                            550
                                                                       2,750.0
                                                                           -
                                                                         275.0
                                                                         137.5
                                                                       $323,283

Onshore Petroleum and Natural Gas Production new reporters [1,2,3]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                             50
                                                                         250.0

                                                                          25.0
                                                                          12.5
                                                                        $29,389

Natural Gas Distribution reporters [1,2]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                            177
                                                                         885.0
                                                                           -
                                                                          88.5
                                                                          44.3
                                                                       $104,038

LNG Storage reporters [1,2]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                              4
                                                                          20.0
                                                                           -
                                                                           2.0
                                                                           1.0
                                                                         $2,351

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [1,2,4]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                            200
                                                                       1,000.0

                                                                         100.0
                                                                          50.0
                                                                       $117,558

Natural Gas Transmission Pipeline reporters [1,2,4]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                            183
                                                                         915.0

                                                                          91.5
                                                                          45.8
                                                                       $107,565

Offshore Petroleum and Natural Gas Production reporters [2,5]
                                                                           1.00
                                                                              1
                                                                           1.00
                                                                            126
                                                                         126.0
                                                                           -
                                                                          12.6
                                                                           6.3
                                                                        $14,812

A2. Read Rule, Instructions, Guidance Documents for Subpart A [6]
                                                                           5.00
                                                                              1
                                                                           5.00
                                                                          2,305
                                                                      11,525.0
                                                                           -
                                                                       1,152.5
                                                                         576.3
                                                                     $1,354,850

B. Required Activities

Acid Gas Removal Units

Gather CEMS data for e-GGRT reporting (M1)

Onshore Natural Gas Processing reporters [2,7][,8]
                                                                           1.00
                                                                            1.7
                                                                           1.67
                                                                              6
                                                                          10.0

                                                                           $992

Onshore Petroleum and Natural Gas Production existing reporters [2,7][,10]
                                                                           1.00
                                                                            1.0
                                                                           1.00
                                                                              0

                                                                             $0

Onshore Petroleum and Natural Gas Production new reporters [2,7][,11]
                                                                           1.00
                                                                            1.0
                                                                           1.00
                                                                              0

                                                                             $0

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [2.7][,11]
                                                                           1.00
                                                                            1.0
                                                                           1.00
                                                                              0

                                                                             $0

Conduct quarterly gas sampling (M2)

Onshore Natural Gas Processing reporters [12,13,14]
                                                                           0.67
                                                                            1.3
                                                                           0.87
                                                                             64
                                                                          55.5

                                                                           5.5
                                                                           2.8
                                                                         $6,521

Onshore Petroleum and Natural Gas Production existing reporters [12,13]
                                                                           0.67
                                                                            1.0
                                                                           0.67
                                                                              6
                                                                           4.0

                                                                           0.4
                                                                           0.2
                                                                           $470

Onshore Petroleum and Natural Gas Production new reporters [11,12]
                                                                           0.67
                                                                            0.0
                                                                           0.00
                                                                              0

                                                                             $0

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [11,12]
                                                                           0.67
                                                                            0.0
                                                                           0.00
                                                                              0

                                                                             $0

Perform engineering calculation (M3)

Onshore Natural Gas Processing reporters [13,15]
                                                                           0.53
                                                                            1.4
                                                                           0.75
                                                                            112
                                                                          83.6

                                                                           8.4
                                                                           4.2
                                                                         $9,831

Onshore Petroleum and Natural Gas Production existing reporters [13,15]
                                                                           0.53
                                                                            1.0
                                                                           0.53
                                                                              9
                                                                           4.8

                                                                           0.5
                                                                           0.2
                                                                           $564

Onshore Petroleum and Natural Gas Production new reporters [11,15]
                                                                           0.53
                                                                            0.0
                                                                           0.00
                                                                              0

                                                                             $0

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [11,15]
                                                                           0.53
                                                                            0.0
                                                                           0.00
                                                                              0

                                                                             $0

Perform simulation run (M4)

Onshore Natural Gas Processing reporters [13,15]
                                                                           0.17
                                                                            1.5
                                                                           0.25
                                                                             48
                                                                          12.0

                                                                           1.2
                                                                           0.6
                                                                         $1,411

Onshore Petroleum and Natural Gas Production existing reporters [13,15]
                                                                           0.17
                                                                            1.9
                                                                           0.32
                                                                             15
                                                                           4.8

                                                                           0.5
                                                                           0.2
                                                                           $558

Onshore Petroleum and Natural Gas Production new reporters [11,15,16]
                                                                           0.17
                                                                            2.0
                                                                           0.33
                                                                             50
                                                                          16.7

                                                                           1.7
                                                                           0.8
                                                                         $1,959

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [11,15,17]
                                                                           0.17
                                                                            2.0
                                                                           0.33
                                                                            200
                                                                          66.7

                                                                           6.7
                                                                           3.3
                                                                         $7,837

Equipment Leaks

Conduct Leak Detection Surveys

Onshore Natural Gas Processing reporters [18]
                                                                           4.00
                                                                              1
                                                                           4.00
                                                                            418
                                                                       1,672.0

                                                                       $165,829

Onshore Natural Gas Transmission Compression reporters [18]
                                                                           4.00
                                                                              1
                                                                           4.00
                                                                            480
                                                                       1,920.0

                                                                       $190,426

Underground Natural Gas Storage reporters [18]
                                                                           4.00
                                                                              1
                                                                           4.00
                                                                             45
                                                                         180.0

                                                                        $17,852

LNG Import and Export Equipment reporters [18]
                                                                           4.00
                                                                              1
                                                                           4.00
                                                                              7
                                                                          28.0

                                                                         $2,777

Natural Gas Distribution reporters [18]
                                                                           4.00
                                                                              1
                                                                           4.00
                                                                            103
                                                                         412.0

                                                                        $40,862

LNG Storage reporters [18]
                                                                           4.00
                                                                              1
                                                                           4.00
                                                                              3
                                                                          12.0

                                                                         $1,190

Determine emissions using population counts

Onshore Petroleum and Natural Gas Production existing reporters [19,20]
                                                                           0.45
                                                                              1
                                                                           0.45
                                                                            503

                                                                         226.4

                                                                        $11,960

Onshore Petroleum and Natural Gas Production new reporters [19]
                                                                           4.50
                                                                              1
                                                                           4.50
                                                                              0

                                                                             -

                                                                             $0

Onshore Petroleum and Natural Gas Production new reporters [19,20]
                                                                           0.45
                                                                              1
                                                                           0.45
                                                                             50

                                                            22.5

                                                                         $1,189

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [19]
                                                                           4.50
                                                                              1
                                                                           4.50
                                                                              0

                                                                              -

                                                                             $0

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [19,20]
                                                                           0.45
                                                                              1
                                                                           0.45
                                                                            200

                                                              90

                                                                         $4,756

Blowdown Vent Stacks

Calculate emissions

Onshore Natural Gas Processing reporters [13, 15]
                                                                           0.13
                                                                            8.2
                                                                           1.09
                                                                             90
                                                                          98.4

                                                                           9.8
                                                                           4.9
                                                                        $11,568

Onshore Natural Gas Transmission Compression reporters [13, 15]
                                                                           0.13
                                                                            7.7
                                                                           1.03
                                                                            202
                                                                         207.4

                                                                          20.7
                                                                          10.4
                                                                        $24,380

LNG Import and Export Equipment reporters [13, 15]
                                                                           0.13
                                                                            9.0
                                                                           1.20
                                                                              3
                                                                           3.6

                                                                           0.4
                                                                           0.2
                                                                           $423

Natural Gas Transmission Pipeline reporters [15,20]
                                                                           0.13
                                                                             15
                                                                           2.00
                                                                            183
                                                                         366.0

                                                                          36.6
                                                                          18.3
                                                                        $43,026

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [15,20]
                                                                           0.13
                                                                            8.0
                                                                           1.07
                                                                            200
                                                                         213.3

                                                                          21.3
                                                                          10.7
                                                                        $25,079

Centrifugal Compressors

Measure volumetric emissions from centrifugal compressors

Onshore Natural Gas Processing reporters [13,21,22]
                                                                           0.50
                                                                            3.1
                                                                           1.55
                                                                            153
                                                                         237.2

                                                                        $23,521

Onshore Natural Gas Transmission Compression reporters [13,21,23]
                                                                           0.50
                                                                            2.4
                                                                           1.20
                                                                            343
                                                                         411.6

                                                                        $40,822

Underground Natural Gas Storage reporters [13,21,24]
                                                                           0.50
                                                                            3.5
                                                                           1.75
                                                                             10
                                                                          17.5

                                                                         $1,736

LNG Import and Export Equipment reporters [13,21,25]
                                                                           0.50
                                                                            3.2
                                                                           1.60
                                                                              3
                                                                           5.4

                                                                           $476

LNG Storage reporters [13,21,27]
                                                                           0.50
                                                                            1.9
                                                                           0.95
                                                                              1
                                                                           1.0

                                                                            $94

Calculate facility-wide emission factor and calculate mass emissions

Onshore Natural Gas Processing reporters [13,21,22]
                                                                           0.17
                                                                            3.1
                                                                           0.52
                                                                            153
                                                                          79.1

                                                                           7.9
                                                                           4.0
                                                                         $9,293

Onshore Natural Gas Transmission Compression reporters [13,21,23]
                                                                           0.17
                                                                            2.4
                                                                           0.40
                                                                            343
                                                                         137.2

                                                                          13.7
                                                                           6.9
                                                                        $16,129

Underground Natural Gas Storage reporters [13,21,24]
                                                                           0.17
                                                                            3.5
                                                                           0.58
                                                                             10
                                                                           5.8

                                                                           0.6
                                                                           0.3
                                                                           $686

LNG Import and Export Equipment reporters [13,21,25]
                                                                           0.17
                                                                            3.2
                                                                           0.53
                                                                              3
                                                                           1.6

                                                                           0.2
                                                                           0.1
                                                                           $188

LNG Storage reporters [13,21,27]
                                                                           0.17
                                                                            1.9
                                                                           0.32
                                                                              1
                                                                           0.3

                                                                           0.0
                                                                           0.0
                                                                            $37

Determine count and calculate emissions using emission factor

Onshore Petroleum and Natural Gas Production existing reporters [28]
                                                                           0.10
                                                                            1.0
                                                                           0.10
                                                                            207

                                                                          20.7

                                                                         $1,094

Onshore Petroleum and Natural Gas Production new reporters [28]
                                                                           1.00
                                                                            1.0
                                                                           1.00
                                                                              0

                                                                             -

                                                                             $0

Onshore Petroleum and Natural Gas Production new reporters [28]
                                                                           0.10
                                                                            1.0
                                                                           0.10
                                                                             50

                                                                        0.50

                                                                           $264

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [28]
                                                                           1.00
                                                                            1.0
                                                                           1.00
                                                                              0

                                                                             -

                                                                             $0

Onshore Petroleum and Natural Gas Gathering and Boosting reporters [28]
                                                                           0.10
                                                                            1.0
                                                                           0.10
                                                                            200

                                                                        20.0

                                                                         $1,057

Reciprocating Compressors

Measure volumetric emissions from reciprocating compressors

Onshore Natural Gas Processing reporters [13,21,29]
                                                                           0.50
                                                                            7.5
                                                                           3.75
                                                                            347

                                                                       1,301.3

                                                                        $68,758

Onshore Natural Gas Transmission Compression reporters [13,21,30]
                                                                           0.50
                                                                            6.8
                                                                           3.40
                                                                            314

                                                                       1,067.6

                                                                        $56,412

Underground Natural Gas Storage reporters [13,21,31]
                                                                           0.50
                                                                            6.5
                                                                           3.25
                                                                             53

                                                                         172.3

                                                                         $9,102

LNG Import and Export Equipment reporters [13,21,32]
                                                                           0.50
                                                                            3.6
                                                                           1.80
                                                                              6

                                                                          10.8

                                                                           $571


[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Proposed Rules]
[Pages 75349-75351]
[FR Doc No: 2016-26245]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 112, 117, and 507

[Docket No. FDA-2016-D-2841]

Describing a Hazard That Needs Control in Documents Accompanying
the Food, as Required by Four Rules Implementing the FDA Food Safety
Modernization Act: Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a draft guidance for industry entitled
``Describing a Hazard That Needs Control in Documents Accompanying the
Food, as Required by Four Rules Implementing the FDA Food Safety
Modernization Act: Guidance for Industry.'' This draft guidance
explains our current thinking on disclosure statements made by an
entity, in documents accompanying food, that certain hazards have not
been controlled by that entity as required by certain provisions in
four final rules. This document describes our current thinking on how
to describe the hazard under each of the four rules and which documents
we consider to be ``documents of the trade'' for the purpose of
disclosure statements.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on this draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by
May 1, 2017. Submit either electronic or written comments on the
proposed collection of information by May 1, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a

third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2841 for ``Describing a Hazard That Needs Control in
Documents Accompanying the Food, as Required by Four Rules Implementing
the FDA Food Safety Modernization Act: Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug
Administration (HFS-300), 5001 Campus Drive, College Park, MD 20740.
Send two self-addressed adhesive labels to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:  With regard to this draft guidance:
For questions regarding this draft guidance as it relates to our
regulation entitled ``Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Human Food,'' contact
Jenny Scott, Center for Food Safety and Applied Nutrition, (HFS-300),
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-2166.
    For questions regarding this draft guidance as it relates to our
regulation entitled ``Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Food for Animals,''
contact Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-
402-6246.
    For questions regarding this draft guidance as it relates to our
regulation entitled ``Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption,'' contact Samir Assar,
Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.
    For questions regarding this draft guidance as it relates to our
regulation entitled ``Foreign Supplier Verification Programs (FSVP) for
Importers of Food for Humans and Animals,'' contact Rebecca Buckner,
Office of Food and Veterinary Medicine, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``Describing a Hazard That Needs Control in Documents
Accompanying the Food, as Required by Four Rules Implementing the FDA
Food Safety Modernization Act: Guidance for Industry.'' We are issuing
the draft guidance consistent with FDA's good guidance practices
regulation (21 CFR 10.115). The draft guidance, when finalized, will
represent the current thinking of FDA on this topic. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. You can use an alternate approach if it satisfies
the requirements of the applicable statutes and regulations.
    The draft guidance relates to four of the seven foundational rules
that we have established in Title 21 of the Code of Federal Regulations
(21 CFR) as part of our implementation of the FDA Food Safety
Modernization Act (FSMA) (Pub. L. 111-353). Table 1 lists these four
rules. Each of these rules includes ``customer provisions'' as
specified in table 1.

                    Table 1--The Four Foundational FSMA Rules Relevant to the Draft Guidance
----------------------------------------------------------------------------------------------------------------
   Title and abbreviations for the
       purpose of this document        Regulatory codification  ``Customer provisions''        Publication
----------------------------------------------------------------------------------------------------------------
Current Good Manufacturing Practice,   21 CFR part 117........  21 CFR 117.136(a)(2),    80 FR 55908, September
 Hazard Analysis, and Risk-Based                                 (3), and (4).            17, 2015.
 Preventive Controls for Human Food
 (part 117).

Current Good Manufacturing Practice,   21 CFR part 507........  21 CFR 507.36(a)(2),     80 FR 56170, September
 Hazard Analysis, and Risk-Based                                 (3), and (4).            17, 2015.
 Preventive Controls for Food for
 Animals (part 507).
Standards for the Growing,             21 CFR part 112........  21 CFR 112.2(b)........  80 FR 74354, November
 Harvesting, Packing, and Holding of                                                      27, 2015.
 Produce for Human Consumption
 (produce safety regulation).
Foreign Supplier Verification          21 CFR part 1, subpart   21 CFR 1.507(a)(2)(i),   80 FR 74226, November
 Programs (FSVP) for Importers of       L.                       (a)(3)(i), and           27, 2015.
 Food for Humans and Animals (FSVP                               (a)(4)(i).
 regulation).
----------------------------------------------------------------------------------------------------------------

    The ``customer provisions'' of part 117 and part 507 each include a
requirement for a ``disclosure statement'' in which a manufacturer/
processor must disclose, in documents accompanying the food, in
accordance with the practice of the trade, that the food is ``not
processed to control [identified hazard]'' in certain circumstances.
Likewise, the ``customer provisions'' of the FSVP regulation include a
requirement for a ``disclosure statement'' in which an importer must
disclose, in documents accompanying the food, in accordance with the
practice of the trade, that the food is ``not processed to control
[identified hazard]'' in certain circumstances. The ``customer
provisions'' of the produce safety regulation relate to an exemption
from that regulation that includes a requirement for a ``disclosure
statement'' in which a farm must disclose, in documents accompanying
the food, in accordance with the practice of the trade, that the food
is ``not processed to adequately reduce the presence of microorganisms
of public health significance.''
    The draft guidance responds to industry questions regarding these
requirements for a disclosure statement. On March 23, 2016, FDA met
with a food trade association at their request to listen to concerns
regarding the customer provisions of part 117 (Ref. 1), including
concerns regarding the disclosure statement in part 117. At the
meeting, the trade association expressed concern about providing a
disclosure statement when multiple hazards may be present, including
chemical hazards (such as mycotoxins) and physical hazards (such as
stones in raw agricultural commodities), as well as for multiple
biological hazards (such as microbial pathogens). The trade association
also asked us to allow a variety of types of documents that accompany
the food to have the disclosure statement (e.g., contractual
agreements, Web sites referenced on labels and in contracts, labels,
letters of guarantee, shipment-specific certificates of analysis,
shipping documents, specifications, and terms and conditions).
    The trade association focused its discussion on the requirements of
part 117, but noted that it had parallel concerns for the analogous
provisions of part 507 and the FSVP regulation (Ref. 1). Although the
trade association did not express concern with the disclosure statement
in the produce safety regulation, we believe it will be helpful to
businesses subject to the produce safety regulation, to include our
current thinking on the disclosure statement in all four rules that
have requirements for a disclosure statement, not just the three rules
mentioned by the trade association.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 117 have been approved under
OMB control number 0910-0751. The collections of information in 21 CFR
part 507 have been approved under OMB control number 0910-0789. The
collections of information in 21 CFR part 112 have been approved under
OMB control number 0910-0816. The collections of information in 21 CFR
part 1, subpart L have been approved under OMB control number 0910-
0752.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

IV. References

    The following references are on display in the Division of Dockets
Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are
available for viewing by interested persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also available electronically at http://www.regulations.gov.

1. Grocery Manufacturers Association, ``21 CFR 117.136. Industry
Impacts from Disclosure and Written Assurance Requirements,'' 2016.

    Dated: October 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26245 Filed 10-28-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Notices]
[Page 36200-36202]
[DOCID:fr22jy09-65]

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

ENVIRONMENTAL PROTECTION AGENCY

EPA-HQ-OPP-2009-0484; FRL-8425-8]

Notice of Receipt of Several Pesticide Petitions Filed for
Residues of Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the Agency's receipt of several initial
filings of pesticide petitions proposing the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before August 21, 2009.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number and the pesticide petition number (PP) for
the petition of interest as shown in the body of this document, by one
of the following methods:

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

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Biopesticides and Pollution Prevention Division (7511P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have a typical or disproportionately high and adverse
human health impacts or environmental effects from exposure to the
pesticides discussed in this document, compared to the general
population.

II. What Action is the Agency Taking?

     EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C. 346a, proposing the establishment
or modification of regulations in 40 CFR part 174 or part 180 for
residues of pesticide chemicals in or on various food commodities. EPA
has determined that the pesticide petitions described in this notice
contain the data or information prescribed in FFDCA section 408(d)(2);
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the pesticide
petitions. Additional data may be needed before EPA can make a final
determination on these pesticide petitions.
     Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that is the subject of this notice, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://
www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerance Exemptions

    1. PP 7E7188. (EPA-HQ-OPP-2009-0407). Sellew and Associates LLC.,
84 Shadybrook Lane, Carlisle, MA 01741, proposes to establish an
exemption from the requirement of a tolerance for residues of the
microbial pesticide, Trichoderma hamatum Isolate 382, in or on all food
commodities. The petitioner believes no analytical method is needed
because Sellew and Associates LLC., is proposing to establish an
exemption from the requirement of a tolerance without numerical
limitation. For this reason an analytical method for detecting and
measuring levels of the pesticide residue is considered unnecessary.
Contact: Ann Sibold,<PHONE_NUMBER><EMAIL_ADDRESS>    2. PP 9F7558. (EPA-HQ-OPP-2009-0440). Technology Sciences Group
Inc., 1150 18th St., NW., Suite 1000, Washington, DC 20036, acting on
behalf of Biomor Israel Ltd., PO Box 81, Qatzrin 12900, ISRAEL,
proposes to establish an exemption from the requirement of a tolerance
for residues of the biochemical pesticide, Tea Tree Oil, in or on all
food commodities. The petitioner believes no analytical method is
needed because Biomor Israel Ltd., is proposing to establish an
exemption from the requirement of a tolerance without numerical
limitation. For this reason an analytical method for detecting and
measuring levels of the pesticide residue is considered unnecessary.
Contact: Raderrio Wilkins,<PHONE_NUMBER><EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: July 15, 2009.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

[FR Doc. E9-17401 Filed 7-21-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Page 62831]
[FR Doc No: 2023-19790]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-325, OMB Control No. 3235-0385]

Proposed Collection; Comment Request; Extension: Rule 15g-9

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

    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-9 (17 CFR 240.15g-9)
(the ``Rule''), under the Securities Exchange Act of 1934 (15 U.S. C.
78a et seq.) (the ``Exchange Act''). The Commission plans to submit
this existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Section 15(c)(2) of the Exchange Act (15 U.S.C. authorizes the
Commission to promulgate rules that prescribe means reasonably designed
to prevent fraudulent, deceptive, or manipulative practices in
connection with over-the-counter (``OTC'') securities transactions.
Pursuant to this authority, the Commission in 1989 adopted Rule 15c2-6,
which was subsequently redesignated as Rule 15g-9, 17 CFR 240.15g-9.
The Rule requires broker-dealers to produce a written suitability
determination for, and to obtain a written customer agreement to,
certain recommended transactions in penny stocks that are not
registered on a national securities exchange, and whose issuers do not
meet certain minimum financial standards. The Rule is intended to
prevent the indiscriminate use by broker-dealers of fraudulent, high
pressure telephone sales campaigns to sell penny stocks to
unsophisticated customers.
    The Commission staff estimates that approximately five percent of
registered broker-dealers, or 175 broker-dealers,\1\ are subject to the
Rule (5% x approximately 3,497 registered broker-dealers = 175 broker-
dealers). As indicated above, the burden of the Rule on a respondent
varies widely depending on the frequency with which new customers are
solicited. On average, for all respondents, the staff has estimated
that respondents process three new customers per week, or approximately
156 new customers requiring suitability determinations per year. We
also estimate that a broker-dealer would take approximately one-half
hour per new customer in obtaining, reviewing, and processing
(including transmitting to the customer) the information required by
Rule 15g-9, and each respondent would consequently spend 78 hours
annually (156 new customers x .5 hours) obtaining the information
required in the Rule. This would result in 27,300 annual responses per
year for all respondents (175 respondents x 156 new customer
suitability determinations per year). We determined, based on the
estimate of 175 broker-dealer respondents, that the annual hour burden
of Rule 15g-9 is 13,650 hours (175 respondents x 78 hours).
---------------------------------------------------------------------------

    \1\ As of July 1, 2023, there are 3,497 registered broker-
dealers. 5% of 3,497 is 174.85, rounded up to 175.
---------------------------------------------------------------------------

    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 by
November 13, 2023.
    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.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549, or send an email to:
[email protected].

    Dated: September 8, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-19790 Filed 9-12-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Pages 6205-6207]
[FR Doc No: 2018-02924]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0044]

Merchant Marine Personnel Advisory Committee

AGENCY: U.S. Coast Guard, Department of Homeland Security.

ACTION: Notice of Federal Advisory Committee meeting.

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

SUMMARY: The Merchant Marine Personnel Advisory Committee and its
Working Groups will meet to discuss various issues related to the
training and fitness of merchant marine personnel. The meetings will be
open to the public.

DATES: The Merchant Marine Personnel Advisory Committee and its Working
Groups are scheduled to meet on Tuesday, March 20, 2018 and on
Wednesday March 21, 2018, from 8:00 a.m. until 5:30 p.m., and the full
Committee is scheduled to meet on Thursday, March 22, 2018, from 8:00
a.m. until 5:30 p.m. Please note that these meetings may adjourn early
if the Committee has completed its business.

ADDRESSES: The meetings will be held at the U.S. Coast Guard's Eighth
Coast Guard District, Hale Boggs Federal Building, 500 Poydras St., New
Orleans, LA 70130 in Room B106.
    Pre-registration Information: Pre-registration is not required for
access. All attendees will be required to provide a REAL ID Act-
compliant government-issued picture identification card in order to
gain admittance to the building. For more information on REAL ID and to
check the compliance status of your state/territory, please see https://www.dhs.gov/real-id and https://www.dhs.gov/real-id-public-faqs.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the Alternate Designated Federal Officer as soon as possible using the
contact information provided in the FOR FURTHER INFORMATION CONTACT
section of this notice.
    Instructions: You are free to submit comments at any time,
including orally at the meetings, but if you want Committee members to
review your comment before the meetings, please submit your comments no
later than March 19, 2018. We are particularly interested in comments
on the issues in the ``Agenda'' section below. You must include
``Department of Homeland Security'' and the docket number USCG-2018-
0044. Written comments may also be submitted using the Federal
eRulemaking Portal at http://www.regulations.gov. If you encounter
technical difficulties with comments submission, contact the individual
listed in the FOR FURTHER INFORMATION CONTACT section below. Comments
received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review the Privacy and Security Notice for the Federal Docket
Management System at https://www.regulations.gov/privacyNotice.
    Docket Search: For access to the docket to read documents or
comments related to this notice, go to http://www.regulations.gov, type
USCG-2018-0044 in the ``Search'' box, press Enter, and then click on
the item you wish to view.

FOR FURTHER INFORMATION CONTACT: Mr. Davis Breyer, Alternate Designated
Federal Officer of the Merchant Marine Personnel Advisory Committee,
2703 Martin Luther King Jr. Ave. SE, Stop 7509, Washington, DC 20593-
7509, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER> or
[email protected].

SUPPLEMENTARY INFORMATION: Notice of this meeting is given pursuant to
the Federal Advisory Committee Act, Title 5 United States Code
Appendix.
    The Merchant Marine Personnel Advisory Committee was established
under authority of section 310 of the Howard Coble Coast Guard and
Maritime Transportation Act of 2014, codified at Title 46, United
States Code, section 8108, and chartered under the provisions of the
Federal Advisory Committee Act, (Title 5, United States Code,
Appendix). The Committee acts solely in an advisory capacity to the
Secretary of the Department of Homeland Security through the Commandant
of the U.S. Coast Guard on matters relating to personnel in the United
States merchant marine, including training, qualifications,
certification, documentation, and fitness standards and other matters
as assigned by the Commandant. The Committee shall also review and
comment on proposed U.S. Coast Guard regulations and policies relating
to personnel in the United States merchant marine, including training,
qualifications, certification, documentation, and fitness standards;
may be given special assignments by the Secretary and may conduct
studies, inquiries, workshops, and fact finding in consultation with
individuals and groups in the private sector and with State or local
governments; and shall advise, consult with, and make recommendations
reflecting its independent judgment to the Secretary.

Agenda

Day 1

    The agenda for the March 20, 2018, meeting is as follows:
    (1) The Committee will facilitate, under Task Statement 101,
Provide feedback and avenues to further enhance open communication
between external stakeholders and the U.S. Coast Guard's mariner
credentialing program regarding all aspects of the program, the U.S.
Coast Guard Authorization Act of 2015, section 315 requirement that the
``Coast Guard Performance Technology Center--
    (A) prioritizes the review of examinations required for merchant
mariner credentials; and
    (B) not later than 3 years after the date of enactment of the U.S.
Coast Guard Authorization Act of 2015, completes a formal review,
including an appropriate analysis, of the topics and testing
methodology employed by the National Maritime Center for merchant
seamen licensing.''
    This task is available for viewing at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/merpac.
    (2) The Performance Technology Center has been actively collecting
data from the stakeholders on issues related to the examination
process. The team has been working with U.S. Coast Guard personnel;
U.S. Coast Guard approved training providers, and other federal
agencies and private organizations that conduct examinations. As part
of the data collection process the U.S. Coast Guard will be seeking
active input from all facets of maritime industry in this important
initiative on March 20, 2018, as follows:
    (3) At 8:00 a.m. the members of the Merchant Marine Personnel
Advisory Committee and the attending public will meet in an informal
discussion group in order to provide insight on maritime labor's
experience with the merchant mariner credentialing examination system
and process to the Performance Technology Center. All other Committee
members and members of the public are also welcome to participate.
    (4) At 10:30 a.m. the members of the Merchant Marine Personnel
Advisory Committee and the attending public will meet in an informal
discussion group in order to provide insight on shipowners' experience
with the merchant mariner credentialing examination system and process
to the Performance Technology Center. All other Committee members and
members of the public are also welcome to participate.
    (5) At 2:00 p.m. the members of the Merchant Marine Personnel
Advisory Committee and the attending public will meet in an informal
discussion group in order to provide insight on maritime training
providers' experience with the merchant mariner credentialing
examination system and process to the Performance Technology Center.
All other Committee members and members of the public are also welcome
to participate.
    The U.S. Coast Guard Performance Technology Center website is
http://www.forcecom.uscg.mil/Our-Organization/FORCECOM-DIVISIONS/Training/Training-Branches/FC-Tptc/.
    (6) Adjournment of meeting.

Day 2

    The agenda for the March 21, 2018, meeting is as follows:
    (1) The full Committee will meet briefly to discuss the Working
Groups' business/task statements, which are listed under paragraph
2(a)-(h) below.
    (2) Working Groups will separately address the following task
statements which are available for viewing at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/merpac:
    (a) Task Statement 87, Review of policy documents providing
guidance on the implementation of the December 24, 2013, International
Convention on Standards of Training, Certification and Watchkeeping for
Seafarers rulemaking;
    (b) Task Statement 89, Review and update of the International
Maritime Organization's Maritime Safety Committee Circular MSC/
Circ.1014 Guidelines on fatigue mitigation and management
    (c) Task Statement 90, Review of International Maritime
Organization's Model Courses Being Validated by the International
Maritime Organization's Subcommittee on Human Element, Training and
Watchkeeping
    (d) Task Statement 96, Review and comment on the course and program
approval requirements including 46 CFR 10.402, 10.403, 10.407 and
Navigation and Vessel Inspection Circular 03-14 guidelines for approval
of training courses and programs;
    (e) Task Statement 98, Continue the progress made by the military
services towards meeting the goals on the use of Military Education,
Training and Assessment for STCW and National Mariner Endorsements as
identified in the Howard Coble Coast Guard and Maritime Transportation
Act of 2014 and subsequent legislation;
    (f) Task Statement 101, Provide feedback and avenues to further
enhance open communication between external stakeholders and the U.S.
Coast Guard's mariner credentialing program regarding all aspects of
the program;
    (g) Task Statement 102, Consider and make recommendations regarding
the current requirement for a U.S. Merchant Mariner to read and write
using English;
    (h) Task Statement 103, Input to Support Regulatory Reform of Coast
Guard Regulations--Executive Orders 13771 and 13783.
    (3) Public comment period.
    (4) Reports of Working Groups. At the end of the day, the Working
Groups will report to the full Committee on what was accomplished in
their meetings. The full Committee will not take action on these
reports on this date. Any

official action taken as a result of these Working Group meetings will
be taken on day three of the meeting.
    (5) Adjournment of meeting.

Day 3

    The agenda for the March 22, 2018, full Committee meeting is as
follows:
    (1) Introduction.
    (2) Swearing in of newly appointed Committee members.
    (3) Remarks from U.S. Coast Guard Leadership.
    (4) Designated Federal Officer announcements.
    (5) Roll call of Committee members and determination of a quorum.
    (6) Reports from the following Working Groups:
    (a) Task Statement 87, Review of policy documents providing
guidance on the implementation of the December 24, 2013, International
Convention on Standards of Training, Certification and Watchkeeping for
Seafarers rulemaking;
    (b) Task Statement 89, Review and update of the International
Maritime Organization's Maritime Safety Committee Circular MSC/Circ.
1014 Guidelines on fatigue mitigation and management
    (c) Task Statement 90, Review of International Maritime
Organization's Model Courses Being Validated by the International
Maritime Organization's Subcommittee on Human Element, Training and
Watchkeeping
    (d) Task Statement 96, Review and comment on the course and program
approval requirements including 46 CFR 10.402, 10.403, 10.407 and
Navigation and Vessel Inspection Circular 03-14 guidelines for approval
of training courses and programs;
    (e) Task Statement 98, Continue the progress made by the military
services towards meeting the goals on the use of Military Education,
Training and Assessment for STCW and National Mariner Endorsements as
identified in the Howard Coble Coast Guard and Maritime Transportation
Act of 2014 and subsequent legislation;
    (f) Task Statement 101, Provide feedback and avenues to further
enhance open communication between external stakeholders and the Coast
Guard's mariner credentialing program regarding all aspects of the
program;
    (g) Task Statement 102, Consider and make recommendations regarding
the current requirement for a U.S. Merchant Mariner to read and write
using English;
    (h) Task Statement 103, Input to Support Regulatory Reform of Coast
Guard Regulations--Executive Orders 13771 and 13783.
    (7) New Business regarding an addendum to Task Statement 101
regarding the cancellation of Medical Certificates.
    (8) Other items for discussion:
    (a) Report on the Mariner Credentialing Program;
    (b) Report on National Maritime Center activities from the National
Maritime Center Commanding Officer;
    (c) Briefings about other on-going U.S. Coast Guard projects
related to personnel in the U.S. merchant marine.
    (9) Public comment period.
    (10) Discussion of Working Group recommendations.
    The Committee will review the information presented on each issue,
deliberate on any recommendations presented by the Working Groups,
approve/formulate recommendations and close any completed tasks.
Official action on these recommendations may be taken on this date.
    (11) Closing remarks/plans for next meeting.
    (12) Adjournment of meeting.
    A public comment period will be held during each Working Group and
full Committee meeting concerning matters being discussed.
    A copy of all meeting documentation will be available at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/merpac no later than March 19, 2018. Alternatively, you may
contact Mr. Davis Breyer as noted in the FOR FURTHER INFORMATION
section above.
    Public comments will be limited to three minutes per speaker.
Please note that the public comment periods will end following the last
call for comments. Please contact Mr. Davis Breyer, listed in the FOR
FURTHER INFORMATION CONTACT section, to register as a speaker.
    A public comment period will be held during each Working Group and
full Committee meeting concerning matters being discussed.
    Please note that the meeting may adjourn early if the work is
completed.

    Dated: February 8, 2018.
Jeffrey G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2018-02924 Filed 2-12-18; 8:45 am]
 BILLING CODE 9110-04-P


Federal EPA Hearings March 8th 2006 Dr. David Pepper   People   Particulates   The Precautionary Principle Asthma in Fresno Children Asthma in Fresno Children Fresno Unified School District 0 1000 2000 3000 4000 5000 6000 7000 1982

83 1983

84 1984

85 1985

86 1986

87 1987

88 1988

89 1989

90 1990

91 1991

92 1992

93 1993

94 1994

95 1995

96 1996

97 1997

98 1999 Academic Year of Report Number of Cases Asthma f Asthma Rx ADHD f ADHD Rx Migraine f Migraine Rx Asthma in Elementary School Children prevalence by family income level 0 5 10 15 20 25 30 35 Alameda Sacramento Merced Fresno Tulare Kern Los Angeles Riverside San Diego county %

asthma diagnosed Income > $ 40,000/ yr ( above 200% FPL)

Income < $ 40,000/ yr ( below 200% FPL)

CHIS, 2001 Childhood Asthma and Income Childhood Asthma and Income Is Ozone the Real Culprit? PM2.5 Average Concentration 6 7 8 9 10 11 12 1 2 3 4 5 Month 0 1 2 3 4 5 6 7 8 Admissions/

8 Asthma Admissions/ 8 Carbon Monoxide x 2 Asthma at Fresno, 1999  2001 1 8 15 22 29 6 13 20 27 3 10 17 24 31 7 14 21 28 5 12 19 26 2 9 16 23 30 7 14 21 28 4 11 18 25 1 8 15 22 1 8 15 22 29 5 12 19 26 3 10 17 24 31 June July August Sept. Oct. Nov. Dec. Jan. Feb. March April M 0 10 20 30 40 50 60 70 80 90 Micrograms/

m3 Fine ( PM2.5) Aerosols at Fresno, CA,

2002 EPA 24 hr standard EPA Annual standard Combining Air Pollution and Health Dr. Tom Cahill UCD Particle Scientist Dr. David Pepper Fresno Hospital Admits for Asthma Asthma Hospitalizations among children 0 14, 1998 2000 Source: OSHPD Asthma ER visits by children Kaiser Permanente & Medi Cal Alameda County, 2001 Asthma Maintenance med fills for children Kaiser Permanente & Medi Cal Alameda County, 2001 Smoke Plumes in LA Basin Why Clean Air ???

Thank you  .. theairdoctor@ gmail. com Federal EPA Hearings March 8th 2006 Recommendations Dr. David Pepper   PM 2.5   Annual Limit of 12 ug   Daily peak of 25ug   Do NOT exempt Ag or Mining   Coarse Limit of 25ug Edison Average Income ( in thousands)

School School " Wealth Wealth" and Asthma Rates and Asthma Rates EHS Average Income ( in thousands)