[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25435-25436]
[FR Doc No: 2013-10317]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9807-2]

Draft National Pollutant Discharge Elimination System (NPDES)
General Permit for Municipal Separate Storm Sewer Systems in the Middle
Rio Grande Watershed in New Mexico (NMR04A000)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed permit issuance and notice of public
meetings, and public hearing.

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

SUMMARY: EPA Region 6 Water Quality Protection Division, today is
proposing for public comment the issuance of a National Pollutant
Discharge Elimination System (NPDES) general permit for storm water
discharges from municipal separate storm sewer systems (MS4s) located
in the Middle Rio Grande Watershed in the State of New Mexico. This
proposed permit offers discharge authorization to regulated MS4s within
the boundaries of the Bureau of the Census-designated 2000 and 2010
Albuquerque Urbanized Areas and any other MS4s in the watershed
designated by the Director as needing a MS4 permit. This permit is
intended to replace both the individual NPDES Permit NMS000101 issued
on January 31, 2012, and the expired general permits NMR040000 and
NMR04000I for dischargers in this watershed area. The Director is also
providing notice of public meetings and a public hearing to be held
regarding today's proposed general permit.

DATES: Comments must be submitted in writing to EPA on or before July
1, 2013.
    Proposed Documents: The proposed general permit and fact sheet
which sets forth principal facts and the significant factual, legal,
and policy questions considered in the development of the proposed
general permit, may be obtained via the Internet at http://epa.gov/region6/water/npdes/sw/ms4/index.htm.
    To obtain hard copies of these documents or any other information
in the administrative record, please contact Ms. Diane Smith using the
contact information provided below.

How do I comment on this proposal?

    Comment Submittals: Submit your comments, by one of the following
methods:
     Email<EMAIL_ADDRESS>     Mail: Ms. Diane Smith, U.S. Environmental Protection
Agency, Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733.
    Administrative Record: The proposed general permit and other
related documents in the administrative record are on file and may be
inspected any time between 8:00 a.m. and 4:30 p.m., Monday through
Friday, excluding legal holidays, at the addresses listed for
submission of comments. It is recommended that you write or call to the
contact above for an appointment, so the record(s) will be available at
your convenience.
    Public Meetings and Public Hearing: EPA will be holding two
informal public meetings and one public hearing in the Albuquerque
metropolitan area. The public meetings will include a presentation on
the proposed general permit and a question and answer session. Written,
but not oral, comments for the official permit record will be accepted
at the public meetings. Written and oral comments for the official
permit record will be accepted at the public hearing. Public notice of
these meetings and the public hearing was provided in the Albuquerque
Journal on Saturday, April 13, 2013.
    Meeting and Hearing: EXPO New Mexico, African American Performing
Art Center (AAPAC) Auditorium, 300 San Pedro Dr. NE., Albuquerque, NM
87108.
    Time: Public Meeting from 6:00 p.m.; Public Hearing from 7:30 p.m.
    Date: May 14, 2013.
    Meeting Only: USDA Building, First Floor Conference Room, 6200
Jefferson St. NE., Albuquerque, NM 87109.
    Time: Public Meeting at 1:00 p.m.
    Date: May 15, 2013.

FOR FURTHER INFORMATION CONTACT: Ms. Diane Smith, U.S. Environmental
Protection Agency, Region 6, 1445 Ross Avenue, Dallas, Texas 75202-
2733. Telephone:<PHONE_NUMBER>. Email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: A. General Information--This permit
authorizes stormwater discharges to waters of the United States from
MS4s within the Middle Rio Grande Watershed provided the MS4 is located
fully or partially within the corporate boundary of the City of
Albuquerque; is located fully or partially within an urbanized area as
determined by the 2000 and 2010 Decennial Census; is designated as a
regulated MS4 pursuant to 40 CFR 122.32; or this permit may also
authorize an operator of a MS4 covered by this permit for discharges
from areas of a regulated small MS4 located outside an Urbanized Areas
or areas designated by the Director provided the permittee complies
with all permit conditions in all areas covered under the permit. Maps
of 2010 Census urbanized areas are available online at: http://cfpub.epa.gov/npdes/stormwater/urbanmaps.cfm.
    B. Statutory and Regulatory History--The overall intent of the
permit conditions is to support the statutory goals of Section 101 of
the Clean Water Act (CWA) to restore and maintain the chemical,
physical and biological integrity for the Nation's waters. The 1987
Water Quality Act (WQA) amended the CWA by adding section 402(p) which
requires that NPDES permits be issued for various categories of storm
water discharges. Section 402(p)(2) requires permits for five
categories of storm water discharges, commonly referred to as Phase I
of the NPDES Storm Water Program. Included in Phase I are discharges
from large municipal separate storm sewer systems (MS4s) (systems
serving a population of 250,000 or more). Phase I regulations published
November 16, 1990 (55 FR 47990) addressed discharges from large MS4s
including city of Albuquerque MS4, which includes all MS4s located
within the corporate boundary of the city of Albuquerque.
    Section 402(p)(6) of the CWA requires permitting for certain
additional storm water discharges (Phase II of the storm water program)
to protect water quality. EPA promulgated final Phase II storm water
regulations on December 8, 1999 (64 FR 68722). These regulations set
forth the additional categories of discharges to be permitted and the
requirements of the program. The additional discharges to be permitted
included small MS4s located in Urbanized Areas designated by the Bureau
of the Census and those designated by the Director on a case-by-case
basis to protect water quality. This proposed permit would combine
coverage for both Phase I and Phase II regulated MS4s in the
Albuquerque area into a single general permit.
    The discharge control conditions established by this permit are
based on Section 402(p)(3)(B) of the Act which mandates that a permit
for discharges from both Phase I and II MS4s must effectively prohibit
the discharge of non-stormwater to the MS4 and require controls to
reduce pollutants in discharges from the MS4 to the maximum extent
practicable (MEP) including management practices,

control techniques and system design and engineering methods, and such
other provisions as the Administrator deems appropriate for the control
of pollutants. MS4 permits requiring implementation of Best Management
Practices (BMPs) addressing the Six Minimum Control Measures at 40 CFR
122.34(b) are generally deemed to be an appropriate means of meeting
the MEP standard. Protection of water quality and compliance with Total
Maximum Daily Loads (TMDLs) are addressed through the CWA
402(p)(3)(B)(iii) authority for ``other such provisions as the
Administrator deems appropriate for the control of pollutants.''
    Paperwork Reduction Act: The information collection required by
this permit will reduce paperwork significantly by implementation of
electronic reporting requirements. EPA is working on an electronic
notice of intent (eNOI) system so applicants will file their NOIs
online. EPA estimates that it takes 10 to 15 minutes to fill up all
information required by eNOI for each lease block. And it takes much
less time to add, delete, or modify eNOI. EPA will also incorporate an
electronic discharge monitoring report (NetDMR) requirement in the
permit. The time for NetDMR preparation will be much less than that for
paper DMR. The electronic filing systems will also significantly reduce
the mailing cost.
    Regulatory Flexibility Act: The Regulatory Flexibility Act, 5
U.S.C. 601 et seq, requires that EPA prepare a regulatory flexibility
analysis for regulations that have a significant impact on a
substantial number of small entities. As indicated below, the permit
reissuance proposed today is not a ``rule'' subject to the Regulatory
Flexibility Act.

    Dated: April 18, 2013.
Stacey Dwyer,
Acting Director, Water Quality Protection Division, EPA Region 6.
[FR Doc. 2013-10317 Filed 4-30-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Proposed Rules]
[Pages 15160-15162]
[FR Doc No: 2019-07426]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0207; Product Identifier 2019-NE-02-AD]
RIN 2120-AA64

Airworthiness Directives; Safran Aerosystems Life Jackets

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Safran Aerosystems (formerly Zodiac Aerospace Services) life
jackets. This proposed AD was prompted by reports of defective welding
on certain life jackets around the inflation system. This proposed AD
would require removal and replacement of the affected life jackets. We
are proposing this AD to address the unsafe condition on these
products.

DATES: We must receive comments on this proposed AD by May 30, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12 140, 1200 New
Jersey Avenue SE, Washington, DC, 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Zodiac
Aerospace Services, 61 Rue Pierre Curie, CS20001, 78370 Plaisir Cedex,
France; phone: + 33 1 61 34 23 23; fax: + 33 1 61 34 21 13; email:
[email protected]; internet: http://tpi.services.zodiacaerospace.com. You may view this service information
at the FAA, Engine and Propeller Standards Branch, 1200 District
Avenue, Burlington, MA, 01803. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0207; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the mandatory continuing airworthiness information (MCAI),
the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Erin King, Aerospace Engineer, Boston
ACO Branch, FAA, 1200 District Avenue, Burlington, MA, 01803; phone
781-238-7655; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0207;
Product Identifier 2019-NE-02-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA AD 2019-0010, dated January 23, 2019 (referred to after
this as ``the MCAI''), to address the unsafe condition on these
products. The MCAI states:

    Defective welding around the inflation system has been
reportedly found on certain

life jackets on the production line. Subsequent investigation
results identified a batch of life jackets which might be affected
by this manufacturing defect.
    This condition, if not corrected, could lead to inability of the
life jacket to perform its intended function, possible resulting in
injury to the user of that life jacket.
    To address this potential unsafe condition, Safran Aerosystems
issued the SB, providing the list of affected parts, and the repair
SB, providing instructions to repair affected parts.
    For the reason described above, this [EASA] AD requires
replacement of affected life jackets, and allows their
(re)installation on an aircraft only after having being repaired.

    You may obtain further information by examining the MCAI in the AD
docket on the internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2019-0207.

Related Service Information Under 1 CFR Part 51

    We reviewed Zodiac Aerospace Services Service Bulletin (SB) 25-65-
33, Revision 01, dated January 8, 2019, and Zodiac Aerospace Services
SB 25-65-34, Original Issue, dated January 8, 2019. Zodiac Aerospace
Services SB 25-65-33 describes procedures for identifying the affected
life jackets by part number and serial number. Zodiac Aerospace
Services SB 25-65-34 describes procedures for repairing the affected
life jackets. This service information is reasonably available because
the interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by EASA, and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are proposing this AD because we evaluated all the relevant
information provided by EASA and determined the unsafe condition
described previously is likely to exist or develop in other products of
the same type design.

Proposed AD Requirements

    This proposed AD would require removal and replacement of the
affected life jackets.

Costs of Compliance

    We estimate that this proposed AD affects an unknown number of life
jackets installed on, but not limited to, ATR-GIE Avions de Transport
Regional ATR 42 and ATR 72, Airbus A318/A319/A320/A321, Airbus A330,
Airbus A340, Airbus A350, and Airbus A380 airplanes of U.S. registry.
Operators have the option to replace or repair the affected life
jackets. We have no way of determining the number of life jackets that
might be replaced or repaired.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Inspect life jacket........................  0.1 work-hours x $85 per hour =                  $0           $8.50
                                              $8.50.
Replace life jacket........................  0.5 work-hours x $85 per hour =                  96          138.50
                                              $42.50.
Repair life jacket.........................  0.5 work-hours x $85 per hour =                   0           42.50
                                              $42.50.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Safran Aerosystems (formerly Zodiac Aerospace Services): Docket No.
FAA-2019-0207; Product Identifier 2019-NE-02-AD.

(a) Comments Due Date

    We must receive comments by May 30, 2019.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to Safran Aerosystems life jackets with part
number (P/N) 210225-2, P/N 216200-0, or P/N 216203-0, and with a
serial number listed in Table 1 of Zodiac Aerospace Services Service
Bulletin (SB) 25-65-33, Revision 01, dated January 8, 2019, that are
not marked with ``Mod.per SB 25-65-34'' in the identification area.
    (2) These appliances are installed on, but not limited to, ATR-
GIE Avions de Transport Regional ATR 42 and ATR 72, Airbus A318/
A319/A320/A321, Airbus A330, Airbus A340, Airbus A350, and Airbus
A380 airplanes.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2561, Life Jacket.

(e) Unsafe Condition

    This AD was prompted by reports of defective welding on certain
life jackets around the inflation system. We are issuing this AD to
prevent failure of the life jacket. The unsafe condition, if not
addressed, could result in injury to the wearer of the life jacket.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Within six months after the effective date of this AD, remove
each affected life jacket from the airplane and, before further
flight, replace the life jacket with a life jacket eligible for
installation.

(h) Installation Prohibition

    After the effective date of this AD, do not install on any
airplane an affected life jacket unless it has been repaired and
marked to indicate compliance with such repair in accordance with
Zodiac Aerospace Services SB 25-65-34, Original Issue, dated January
8, 2019, or a method approved by the FAA.

(i) Definition

    A life jacket eligible for installation is a new life jacket or
a life jacket repaired in accordance with Zodiac Aerospace Services
SB 25-65-34, Original Issue, dated January 8, 2019, or by a method
approved by the FAA.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the ACO Branch, send it to the attention of the person
identified in paragraph (k)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Erin King,
Aerospace Engineer, Boston ACO Branch, FAA, 1200 District Avenue,
Burlington, MA, 01803; phone<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].
    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2019-0010, dated January 23, 2019, for more information. You may
examine the EASA AD in the AD docket on the internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2019-0207.
    (3) For service information identified in this AD, contact
Zodiac Aerospace Services, 61 Rue Pierre Curie, CS20001, 78370
Plaisir Cedex, France; phone: + 33 1 61 34 23 23; fax: + 33 1 61 34
21 13; email: [email protected]; internet:
http://tpi.services.zodiacaerospace.com. You may view this
referenced service information at the FAA, Engine and Propeller
Standards Branch, 1200 District Avenue, Burlington, MA, 01803. For
information on the availability of this material at the FAA, call
781-238-7759.

    Issued in Burlington, Massachusetts, on April 10, 2019.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2019-07426 Filed 4-12-19; 8:45 am]
 BILLING CODE 4910-13-P


Assessing the Effect of Five Gasoline Properties on Exhaust Emissions from Light-Duty Vehicles certified to Tier-2 Standards

                       Analysis of Data from EPA Phase 3

                                (EPAct/V2/E-89)

                                 Appendix  P.3

                         Model Fitting Information for
                             1,3-Butadiene (Bag 1)

This appendix suFMarizes model fitting for Bag-1 1,3-Butadiene.  Model-fitting techniques and approaches suFMarized in Section 8.7.  Features of the data and modeling for this compound are listed below.
Fuel-parameter matrix:	REDUCED
Media contamination:	NO
No. measurements:	62
No. censored values:	0
Modeling approach:	MIXED MODEL
Estimated Dependent Variable model:	NO

Models fit for 1,3-Butadiene (Bag 1)
Model term
                                   Notation
                                     Model

                          Full Model (Linear Effects)
FM1[1]
FM2
FM3
Null Model[2]
                                     etOH
Ze
                                      ●
                                      ●
                                      ●
                                      ●
                                      x
                                     Arom
Za
                                      ●
                                      ●
                                      x

                                      T50
Z5
                                      ●
                                      ●
                                      ●
                                      x

                                      T90
Z9
                                      ●
                                      x

[1] Denotes "Full minus 1," etc.
[2] Model fit with intercept only.

 Fitting history for 1,3-Butadiene (Bag 1)  -  with "FM3" selected as best fit model.
                                Fit Parameters

                             Test with respect to
                                   Benchmark

                             Test with respect to
                                Previous Model
Model
p
-2lnL
BIC[1]

                                                                        Dev.[1]
                                                                              d
                                                                    Pr>χ[2]

                                                                           Dev.
                                                                              d
                                                                    Pr>χ[2]
Linear Effects
5
                                                                          21.82
                                                                          33.08

FM1
4
                                                                          22.07
                                                                          31.73

                                                                         0.2556
                                                                              1
                                                                           0.61

FM2
3
                                                                          22.61
                                                                          30.66

                                                                         0.7939
                                                                              1
                                                                           0.37

	0.5383
                                                                              1
                                                                           0.46
FM3
2
                                                                          23.66
                                                                          30.10

                                                                         1.8468
                                                                              1
                                                                           0.17

                                                                         1.0529
                                                                              1
                                                                           0.30
Null Model
1
                                                                          39.80
                                                                          44.63

                                                                          17.98
                                                                              1
                                                                        0.00002

                                                                        16.1328
                                                                              1
                                                                         0.0001
[1] A lower value indicates a better fit.

[1] The deviation is the difference in
the -2loglik statistics for the
nested and reference models,
respectively, per Equation 14.

 Coefficients and Type-III Tests of Effect for the Full and Best-Fit Models  -  1,3-Butadiene (Bag 1).
Effect

                                  Full Model

                             Best-Fit Model (FM3)

Estimate
Std.Err.
d.f.
t-value
Pr>t

Estimate
Std.Err.
d.f.
t-value
Pr>t
Intercept

                                                                        -5.9175
                                                                         0.1131
                                                                           5.02
                                                                         -50.97
                                                                     0.00000005

                                                                        -5.9175
                                                                         0.1159
                                                                           5.02
                                                                         -51.04
                                                                      0.0000005
Ze

                                                                        -0.1210
                                                                        0.03986
                                                                          57.04
                                                                          -3.04
                                                                         0.0036

                                                                        -0.1273
                                                                        0.03851
                                                                          57.05
                                                                          -3.30
                                                                         0.0017
Za

                                                                       -0.02730
                                                                        0.03496
                                                                          57.06
                                                                          -0.78
                                                                           0.44

Z5

                                                                         0.0441
                                                                        0.03887
                                                                          57.04
                                                                           1.14
                                                                           0.26

                                                                         003968
                                                                        0.03851
                                                                          57.04
                                                                           1.03
                                                                           0.31
Z9

                                                                       -0.01715
                                                                        0.03389
                                                                          57.10
                                                                          -0.51
                                                                           0.61

                                                                        0.06188

                                                                        0.06161

                                                                        0.06801

                                                                        0.06898


Developing FACDQ Recommendations around Data Quality Objectives

November 20, 2006

Introduction

At its November 1, 2006 meeting, the Policy Work Group agreed to step
back from efforts to reach consensus on Measurement Quality Objectives
(MQOs) and to focus first on reaching consensus on broader data quality
objectives (DQOs) for various detection and quantitation uses.

The Policy Work Group tasked a subgroup (Jim Pletl, Mary Smith, Brian
Englert, Tom Mugan, Nan Thomey, Michael Murray, and John Phillips) with
developing a product to stimulate discussion at the committee’s
December meeting.  The subgroup developed two sets of questions related
to these issues:  fundamental questions related to data quality
objectives and specific questions related to the FACDQ’s
recommendations.

On November 17, the Policy Work Group agreed that the questions posed in
this document are significant and need to be addressed.  The Policy Work
Group agreed to ask all members of the FACDQ to prepare and send their
responses to the questions to the facilitation team by Thursday,
November 30.  The facilitators will compile the responses so they can be
arrayed for discussion at the December 6-8 FACDQ meeting.  Where members
have already submitted responses, they are included in italics.

Definitions

Data Quality Objectives

DQOs are qualitative and quantitative statements that clarify the
purpose of a study, define the most appropriate type of information to
collect, determine the most appropriate conditions from which to collect
that information, and specify tolerable levels of potential decision
errors.  The DQO Process is a series of steps applied to decision-making
(e.g., compliance/non-compliance with a standard) and estimation (e.g.,
ascertaining the mean concentration level of a contaminant).  This
definition is taken from “Guidance on Systematic Planning Using the
Data Quality Objectives Process,” EPA QA/G-4, Office of Environmental
Information EPA/2401/B-06/001 Feb. 2006 (available at
http://www.epa.gov/QUALITY/qs-docs/g4-final.pdf).

Measurement Quality Objectives

Measurement Quality Objectives are defined as qualitative and
quantitative statements of the overall level of uncertainty that a
decision maker is willing to accept in results or decisions derived from
measurements.

Together, MQOs and DQOs provide the statistical framework for planning
and managing measurement plans consistent with the data user’s needs.
(Glossary of Terms, FACDQ 07/05/06)

Fundamental Questions

A.  Should FACDQ make recommendations regarding how to take Data Quality
Objectives into consideration for decision-making?

Yes/No and Why ?

Yes, the FACDQ "Uses in the Clean Water Act program" portion of our
charter specifically ties to setting DQOs.

Maybe, because it relates to the Uses process.

B.  What Data Quality Objectives should be considered by the FACDQ for
recommendations?

What are they? (e.g., specific MQO values or ranges, uncertainty,
representativeness, matrix effects, etc.)

1.   Several of the DQO Process steps as defined in the EPA QA/G4
guidance document.

Introduction, section 0.9 page 11, "Categories of intended uses for
environmental data"

Step One, section 1.2 page 17, "How do you identify the type of intended
use for the study data?"

Step Two, section 2.2 page 22, "Decision and Estimation Problems"

Step Three, section 3.2 pages 27-28, "Availability of appropriate
sampling and analysis methods."

Step Five, pages 39-43, specifically page 41, "How are measurement
detection limits important to selecting an action level?"

Step Six, pages 45-70, specifically page 46, "False Positives, False
Negatives, Uncertainty" also Figs. 7, 8 & 9 and "Types of Intervals"

C.  What are the decisions around which FACDQ should provide advice or
recommendations on goals for DQOs?

List decisions.

Generally speaking EPA guidance document QA/G4 does a fine job
discussing the DQO process, but the FACDQ could provide advice and/or
recommendations specifically regarding Step Six i.e. knowing or
determining False Negative error rate, False Positive error rate, and
Uncertainty (Precision, Bias and Data Comparability)

D.  Should there be goals for analytical methods?

Yes/No

Yes, but it may be Use dependent.

I think of methods as having data quality characteristics associated
with them, including an implied assumption that they are used
competently with properly functioning equipment.  Data quality
objectives are established based on the use of the data in
decision-making.  The characteristics of the method are then evaluated
to select a method that has the appropriate characteristics.

E.  If so, what are those goals?

List goals.

False Positive error rate

False Negative error rate

Method Precision at QL

Method Bias at QL

Data Comparability between labs

Policy Work Group Specific Questions

What DQOs are applicable to the different identified uses?

I would restate this question, "What MQOs are needed to allow for the
DQOs for different identified uses to be met?"  (MQOs - False Positive
error rate, False Negative error rate, Method Precision at QL, Method
Bias at QL, and Data Comparability between labs).

I think there may be different DQOs within a single use depending on the
relationship between the WQBEL and the concentration of the analyte in
the sample.

What are the goals for method performance?

Must answer the prior question first.

How do we account for uncertainty in methods (e.g. sampling, testing)?

We don't need to "account for uncertainty" that should be part of the
DQO process.  We just need to know how to measure uncertainty.

I don’t think there is agreement on how uncertainty is to be measured
and reported.

Does bias have to be taken into consideration in the decision process?

Yes, it is a component of Uncertainty

Can representative data be defined?  What about a robust reasonable
potential process?

This is part of the DQO process.

Should error rates be considered for different uses?

Do you mean FP and FN error rates?  See response to item 1.

Change question to: Should different error rates be considered for
different uses?  Comment: Probably.

What is an acceptable level of decision error, taking into account MQOs
and uncertainty?

Part of the DQO process.

Is it the same in all instances?

If data do not meet specified accuracy, how should they be used (should
data be ignored or should the uncertainty be factored in)?

Must meet specified accuracy or must factor it in as part of the DQO
process.

This should be stated in DQOs and depends on the relationship between
the WQBEL and the concentration of the analyte in the sample.

How do we account for MQOs in reference matrices and in real world
matrices?

Some comparison is needed between the reference matrix performance used
for daily method QC and the real world matrix to determine the
variability or uncertainty added to the method due to sample matrix
effects.

If matrix effects create a huge percent range in testing results, then
do we recommend matrix specific spikes?

Sample matrix must be evaluated at some frequency, as determined by
DQOs.

If MQOs are set, how do you verify that those MQOs are achieved?

On-going QC including: Blanks, FNQS, LCS/LCSD, MS/MSD, also other method
QC performance controls such as calibrations, internal standards and
surrogates.

If MQOs are set, what should be done with those numbers?

Compare them to the methods and various DQO needs.

If we agree to set MQOs, should they be goals or specific requirements?

MQOs are "Objectives."  This means they are the targets which need to be
achieved for a successful outcome of the project.  If you miss the
target you will not bag the trophy.  MQOs may not be specific
requirements, but if they are not achieved the data may need to be
qualified and it may impact both data usability and completeness.

14.  What MQOs, if any, at this time, do you want the FACDQ to recommend
to EPA?

	List responses to the following.

False Positives

Recommended Value(s)

Ramifications

Discussions

False Negatives

Recommended Value(s)

Ramifications

Discussions

Accuracy

Recommended Value(s)

Ramifications

Discussions

Precision

Recommended Value(s)

Ramifications

Discussions

11/20/2006

Draft for Discussion

Document # FACDQ6-07

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Federal Advisory Committee on Detection and Quantitation Approaches and

Uses In Clean Water Act Programs

Policy Work Group

Draft Recommendations Around DQOs