[Federal Register Volume 82, Number 234 (Thursday, December 7, 2017)]
[Proposed Rules]
[Pages 57689-57694]
[FR Doc No: 2017-26291]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2015-0824; FRL-9971-63-Region 5]

Air Plan Approval; Ohio; Infrastructure SIP Requirements for the
2012 PM2.5 NAAQS; Multistate Transport

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve elements of the State Implementation Plan (SIP) submission from
Ohio regarding the infrastructure requirements of section 110 of the
Clean Air Act (CAA) for the 2012 annual fine particulate matter
(PM2.5) National Ambient Air Quality Standard (NAAQS or
standard). The infrastructure requirements are designed to ensure that
the structural components of each state's air quality management
program are adequate to meet the state's responsibilities under the
CAA. This action pertains specifically to infrastructure requirements
concerning interstate transport provisions.

DATES: Comments must be received on or before January 8, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0824 at http://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the Web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Anthony Maietta, Environmental
Protection Specialist, Control Strategies Section, Air Programs Branch
(AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background of this SIP submission?
II. What guidance is EPA using to evaluate this SIP submission?
III. EPA's Review
IV. What action is EPA taking?
V. Statutory and Executive Order Reviews

I. What is the background of this SIP submission?

    This rulemaking addresses a submission from the Ohio Environmental
Protection Agency (OEPA), describing its infrastructure SIP for the
2012 annual PM2.5 NAAQS, dated December 4, 2015.
Specifically, this rulemaking addresses the portion of the submission
dealing with interstate pollution transport under CAA section
110(a)(2)(D)(i), otherwise known as the ``good neighbor'' provision.
The requirement for states to make a SIP submission of this type arises
from section 110(a)(1) of the CAA. Pursuant to section 110(a)(1),
states must submit ``within 3 years (or such shorter period as the
Administrator may prescribe) after the promulgation of a national
primary ambient air quality standard (or any revision thereof),'' a
plan that provides for the ``implementation, maintenance, and
enforcement'' of such NAAQS. The statute directly imposes on states the
duty to make these SIP submissions, and the requirement to make the
submissions is not conditioned upon EPA's taking any action other than
promulgating a new or revised NAAQS. Section 110(a)(2) includes a list
of specific elements that ``[e]ach such plan'' submission must address.
EPA commonly refers to such state plans as ``infrastructure SIPs.''

II. What guidance is EPA using to evaluate this SIP submission?

    EPA highlighted the statutory requirement to submit infrastructure
SIPs within 3 years of promulgation of a new NAAQS in a October 2,
2007, guidance document entitled ``Guidance on SIP Elements Required
Under Sections 110(a)(1) and (2) for the 1997 8-hour Ozone and
PM2.5 National Ambient Air Quality Standards'' (2007
guidance). EPA has issued additional guidance documents and memoranda,
including a September 13, 2013, guidance document titled ``Guidance on
Infrastructure State Implementation Plan (SIP) Elements under Clean Air
Act Sections 110(a)(1) and 110(a)(2)'' (2013 guidance).
    The most recent relevant document was a memorandum published on
March 17, 2016, titled ``Information on the Interstate Transport ``Good
Neighbor'' Provision for the 2012 Fine Particulate Matter National
Ambient Air Quality Standards under Clean Air Act Section
110(a)(2)(D)(i)(I)'' (2016 memorandum). The 2016 memorandum describes
EPA's past approach to addressing interstate transport, and provides
EPA's general review of relevant modeling data and air quality
projections as they relate to the 2012 annual PM2.5 NAAQS.
The 2016 memorandum provides information relevant to EPA Regional
office review of the CAA section 110(a)(2)(D)(i)(I) ``good neighbor''
provision in infrastructure SIPs with respect to the 2012 annual
PM2.5 NAAQS. This rulemaking considers information provided
in that memorandum.
    The 2016 memorandum provides states and EPA Regional offices with
future year annual PM2.5 design values for monitors in the
United States based on quality assured and certified ambient monitoring
data and air quality modeling. The memorandum further describes how
these projected potential design values can be used to help determine
which monitors should be further evaluated to potentially address
whether emissions from other states significantly contribute to
nonattainment or interfere with maintenance of the 2012 annual
PM2.5 NAAQS at those sites. The 2016 memorandum explained
that the pertinent year for evaluating air quality for purposes of
addressing interstate transport for the 2012 PM2.5 NAAQS is
2021, the attainment deadline for 2012 PM2.5 NAAQS
nonattainment areas classified as Moderate. Accordingly, because the
available data included 2017 and 2025 projected average and maximum
PM2.5 design values

calculated through the CAMx photochemical model, the memorandum
suggests approaches states might use to interpolate PM2.5
values at sites in 2021.
    For all but one monitor site in the eastern United States, the
modeling data showed that monitors were expected to both attain and
maintain the 2012 PM2.5 NAAQS in both 2017 and 2025. The
modeling results provided in the 2016 memorandum show that out of seven
PM2.5 monitors located in Allegheny County, Pennsylvania,
one monitor is expected to be above the 2012 annual PM2.5
NAAQS in 2017. Further, that monitor (ID number 420030064) is projected
to be above the NAAQS only under the model's maximum projected
conditions (used in EPA's interstate transport framework to identify
maintenance receptors), and is projected to both attain and maintain
the NAAQS (along with all Allegheny County monitors) in 2025. The
memorandum therefore indicates that under such a condition (where EPA's
photochemical modeling indicates an area will maintain the 2012 annual
PM2.5 NAAQS in 2025 but not attain in 2017) further analysis
of the site should be performed to determine if the site may be a
nonattainment or maintenance receptor in 2021 (the attainment deadline
for moderate PM2.5 areas). The memorandum also indicates
that for certain states with incomplete ambient monitoring data,
additional information including the latest available data, should be
analyzed to determine whether there are potential downwind air quality
problems that may be impacted by transported emissions. This rulemaking
considers these analyses from Ohio, as well as additional analysis
conducted by EPA during review of its submittal.

III. EPA's Review

    This rulemaking proposes action on the portion of Ohio's December
4, 2015, SIP submission addressing the good neighbor provision
requirements of CAA Section 110(a)(2)(D)(i). State plans must address
four requirements of the good neighbor provisions (commonly referred to
as ``prongs''), including:

--Prohibiting any source or other type of emissions activity in one
state from contributing significantly to nonattainment of the NAAQS in
another state (prong one);
--Prohibiting any source or other type of emissions activity in one
state from interfering with maintenance of the NAAQS in another state
(prong two);
--Prohibiting any source or other type of emissions activity in one
state from interfering with measures required to prevent significant
deterioration (PSD) of air quality in another state (prong three); and
--Protecting visibility in another state (prong four).

    This rulemaking is evaluating the December 4, 2015 submission,
specific to prongs one and two of Ohio's interstate transport
provisions in its PM2.5 infrastructure SIP. Prongs three and
four will be evaluated in a separate rulemaking.
    EPA has developed a consistent framework for addressing the prong
one and two interstate transport requirements with respect to the
PM2.5 NAAQS in several previous Federal rulemakings. The
four basic steps of that framework include: (1) Identifying downwind
receptors that are expected to have problems attaining or maintaining
the NAAQS; (2) identifying which upwind states contribute to these
identified problems in amounts sufficient to warrant further review and
analysis; (3) for states identified as contributing to downwind air
quality problems, identifying upwind emissions reductions necessary to
prevent an upwind state from significantly contributing to
nonattainment or interfering with maintenance of the NAAQS downwind;
and (4) for states that are found to have emissions that significantly
contribute to nonattainment or interfere with maintenance of the NAAQS
downwind, reducing the identified upwind emissions through adoption of
permanent and enforceable measures. This framework was most recently
applied with respect to PM2.5 in the Cross-State Air
Pollution Rule (CSAPR), designed to address both the 1997 and 2006
PM2.5 standards, as well as the 1997 ozone standard.
    Ohio's December 4, 2015, submission indicates that the Ohio SIP
contains the following major programs related to the interstate
transport of pollution: Ohio Administrative Code (OAC) Chapters 3745-16
(Stack Height Requirements); 3745-103 (Acid Rain Permits and
Compliance); 3745-14 (Nitrogen Oxides--Budget Trading Program); and
3745-109 (Clean Air Interstate Rule). Ohio also indicates that sources
in the state are complying with CSAPR. In addition, Ohio has responded
to requests by the States of Indiana and West Virginia, implementing
revisions to OAC 3724-18 (Hamilton County and Jefferson County) to
alleviate modeled violations due, in part, to sources in Ohio.
    Ohio's submittal also contains a technical analysis of its
interstate transport of pollution relative to the 2012 annual
PM2.5 NAAQS prepared in October 2015. The technical analysis
studied Ohio sources' contribution to monitored PM2.5 air
quality values in other states, and evaluated downwind areas which were
most influenced by Ohio sources, and whether Ohio would need to take
further steps to decrease its emissions (and therefore contribution) to
those areas. Ohio's technical analysis considers CSAPR rule
implementation, a review of then-current air quality design values, and
other factors such as meteorology and state-wide emissions inventories.
Through its technical analysis, Ohio determined that at the time of
EPA's analysis of its CSAPR rule,\1\ sources in Ohio were projected to
contribute more than the 1% screening threshold toward PM2.5
air quality at certain receptors PM2.5 air quality problems
in Alabama, Georgia, Illinois, Indiana, Iowa, Kentucky, New York,
Pennsylvania, and West Virginia. Ohio then used that information to
evaluate the distance and geography of the downwind states potentially
impacted by Ohio emissions. Ohio also examined the most recent air
quality in those downwind states. (Based on distance and topographical
considerations, Ohio's analysis did not focus on potential contribution
to areas not attaining the 2012 annual PM2.5 NAAQS based on
2012-2014 monitor data in Alaska, California, Idaho, Nevada or Hawaii.)
---------------------------------------------------------------------------

    \1\ Contained in the TSD for EPA's CSAPR rule (76 FR 48208).
EPA's technical analysis included modeled emissions and air quality
for 2012.
---------------------------------------------------------------------------

    Ohio completed its technical analysis before March 17, 2016, when,
as discussed earlier, EPA released updated modeling projections for
2017 and 2025 annual PM2.5 design values meant to assist
states in implementation of their 2012 PM2.5 NAAQS
interstate transport SIPs. As discussed later, however, EPA's review of
Ohio's submittal nevertheless concludes that the March 17, 2016,
updated modeling projections data corroborate the findings of Ohio's
technical analysis. In addition, certified annual PM2.5
design values recorded since Ohio's submittal further confirm Ohio's
technical analysis.
    By looking at 2012-2014 annual PM2.5 design values,
CSAPR-modeled design values, emissions inventory data, and other
factors, Ohio's technical analysis shows that monitored air quality
values in states Ohio potentially contributes to have trended downward
and were in most cases were already lower than the 2012
PM2.5 NAAQS based on 2012-2014 air quality data (the newest
data available at the time of Ohio's technical analysis and submittal).
Table 1 shows

ambient monitoring data for the downwind states that Ohio identified as
areas that could be affected by its emissions. The table contains
county level annual average PM2.5 design value data for
2012-2014. In addition, data used for EPA's expanded review of
PM2.5 design values that includes design values for 2009-
2011, 2010-2012, 2011-2013, 2013-2015, and 2014-2016 is included in the
technical support document (TSD) in the docket, ``[Technical Support
Document for Docket #EPA-R05-OAR-2015-0824].'' The TSD for this action
also looks at air quality trends in Illinois and Pennsylvania, areas
that required further review because of either missing data or
monitored values recently near or above the NAAQS, by showing the
areas' 2012-2014, 2013-2015, and 2014-2016 design values as well as
yearly annual means from 2014 through 2016 for certain counties based
on AQS data. EPA's expanded review, as discussed throughout this
action, supports Ohio's conclusions drawn from the data shown in Table
1.

  Table 1--Monitored PM2.5 Air Quality in Counties That Ohio Potentially Contributes One Percent or More Toward
                                              PM2.5 Concentrations
----------------------------------------------------------------------------------------------------------------
                                                                     2012-2014       2013-2015       2014-2016
                                                                   Annual PM2.5    Annual PM2.5    Annual PM2.5
               State                            County            DV ([micro]g/m  DV ([micro]g/m  DV ([micro]g/m
                                                                       \3\)            \3\)            \3\)

----------------------------------------------------------------------------------------------------------------
Alabama............................  Jefferson..................            11.3              11            11.2
Alabama............................  Russell....................            10.7              10             9.7
Alabama............................  Pulaski....................            11.7            10.7            10.3
Georgia............................  Bibb.......................            10.9            10.2            10.1
Georgia............................  Clayton....................            10.3              10             9.9
Georgia............................  Floyd......................            10.3             9.9             9.9
Georgia............................  Fulton.....................              11            10.5            10.4
Georgia............................  Muscogee...................            10.2             9.6             9.6
Georgia............................  Wilkinson..................            10.6              10             9.9
Illinois...........................  Champaign..................             N/A             N/A             N/A
Illinois...........................  Cook.......................             N/A             N/A             N/A
Illinois...........................  Macon......................             N/A             N/A             N/A
Illinois...........................  Madison....................             N/A             N/A             N/A
Illinois...........................  Saint Clair................             N/A             N/A             N/A
Indiana............................  Clark......................            11.8            11.4            10.6
Indiana............................  Dubois.....................            10.9            10.6             9.8
Indiana............................  Lake.......................            11.5              11            10.1
Indiana............................  Madison....................             9.8             9.6               9
Indiana............................  Marion.....................            11.8            11.7            11.4
Indiana............................  Spencer....................            10.5            10.1             9.5
Indiana............................  Vanderburgh................            10.9            10.7            10.1
Indiana............................  Vigo.......................            10.6            10.3             9.7
Iowa...............................  Muscatine..................            10.8            10.4             9.4
Kentucky...........................  Bullitt....................  ..............  ..............  ..............
New York...........................  Bronx......................            10.3             9.4               9
Pennsylvania.......................  Allegheny..................              13            12.6            12.8
Pennsylvania.......................  Beaver.....................            11.3            10.8            10.1
Pennsylvania.......................  Cambria....................            11.6            11.7            10.7
Pennsylvania.......................  Chester....................             9.9              10             9.6
Pennsylvania.......................  Delaware...................            12.3            11.6            11.5
Pennsylvania.......................  Lancaster..................            11.6            11.2            12.8
Pennsylvania.......................  Lebanon....................            12.7            11.7            11.2
Pennsylvania.......................  Northampton................            10.5              10             9.3
Pennsylvania.......................  Westmoreland...............            10.1             9.8             8.7
West Virginia......................  Brooke.....................            11.1            11.2            10.5
West Virginia......................  Marshall...................            11.1            10.7            10.2
Texas..............................  El Paso....................              11             9.9             9.4
Wisconsin..........................  Eau Claire.................             7.9             7.5             7.1
----------------------------------------------------------------------------------------------------------------
* Value does not contain a complete year's worth of data.

    In all areas where three years of certified data exist to determine
annual PM2.5 design values for 2012-2014, only three
counties in Pennsylvania recorded values above the NAAQS: Allegheny,
Delaware, and Lebanon counties (which will be discussed in detail
below). Because of errors in protocol made during the recording and/or
analysis of PM2.5 air quality monitors in several states
(for example, improper maintenance of an air quality monitor or not
following proper laboratory analysis procedures), the data from those
monitors could not be quality assured or certified for use in
determining those areas' PM2.5 design values. These data
quality and certification issues were identified by EPA to have
occurred between 2012 and 2015. Therefore, those states had missing
annual PM2.5 design values for certain three-year periods.
The PM2.5 monitoring data for the State of Illinois (the
only state with data quality issues Ohio identified as contributing to)
for all of 2012, 2013, and until July 2014 suffered from data quality/
completion issues and therefore no current annual PM2.5
design values exist for Illinois. By making corrections in protocol at
laboratories that review PM2.5 air monitor samples (for
example, maintaining the laboratory's air temperature to within
specified limits so as not to cause errors in PM sample analysis) and
by rectifying other

deficiencies identified by EPA, we have determined that these quality
control issues have been fully resolved for Illinois (and all states
referenced in this analysis). While Illinois has resolved its quality
control issues, it has still not recorded three full years of certified
data to be able to determine annual PM2.5 design values for
its counties.
    EPA considered available data from monitors in Illinois for its
analysis of Ohio's submittal. As noted, there is only partial year
Illinois data for 2014. However, our review looks at the most recent
valid data available, which are Illinois' recorded 2015-2016 annual
average mean values for monitors in each county, to determine whether
data and downward trends demonstrated in other states in Ohio's
technical analysis are also demonstrated in Illinois. As discussed
below, generally the data show a steady decline in annual
PM2.5 concentrations across all sites in Illinois, with most
counties' 2016 annual means well below the NAAQS. Table 2 shows the
annual mean PM2.5 values for 2015 and 2016.

        Table 2--Annual Mean PM2.5 Values for Illinois, 2015-2016
------------------------------------------------------------------------
                                            2015 PM2.5      2016 PM2.5
                                            Annual mean     Annual mean
                 County                     ([micro]g/m     ([micro]g/m
                                               \3\)            \3\)
------------------------------------------------------------------------
Champaign...............................             8.6             7.6
Cook....................................            12.5             9.4
DuPage..................................               9             7.8
Hamilton................................             8.2             7.8
Jersey..................................             7.7           * 7.9
Kane....................................             8.9               8
Macon...................................             8.7             7.8
Madison.................................            10.4             9.1
McHenry.................................             9.9             7.3
McLean..................................             7.6             7.6
Peoria..................................             8.6             7.6
Randolph................................             7.9               8
Rock Island.............................             9.1             7.2
Sangamon................................             8.2             7.7
Saint Clair.............................            10.7              10
Will....................................             9.1             7.8
Winnebago...............................             9.1             7.8
------------------------------------------------------------------------
* Value does not contain a complete year's worth of data.

    Based upon our expanded review of these data to include valid
PM2.5 design values for the years 2009-2011, 2010-2012, and
2011-2013 (located in the TSD) and despite not having three complete
recent years of certified, quality-assured monitoring data or annual
PM2.5 design values--Illinois' air quality trends reflect
what is shown across the nation: a general downward trend in ambient
air concentrations, including at sites in the states that Ohio analyzed
in its submittal. Only three Illinois counties reported 2010-2012
annual PM2.5 design values above the NAAQS: Cook, Madison,
and Saint Clair counties. In Cook County, the 2010-2012 design value
(which is the latest certified design value for the county), was 12.7
[micro]g/m\3\, and despite a slight rise in 2015, the annual mean
values have trended downward. Cook County's annual mean for that year
was 9.4 [micro]g/m\3\, representing a significant decline in monitored
ambient PM2.5. For Madison County, the 2010-2012
PM2.5 design value was 13.5 [micro]g/m\3\, and the 2014-2016
annual means show a trend downward from 12.9 [micro]g/m\3\ to 9.1
[micro]g/m\3\, a clear and continuous downward trend. For Saint Clair
County, the 2010-2012 PM2.5 design value was 12.2 [micro]g/
m\3\, and the 2014-2016 annual means show a clear and continuous
downward trend from 10.9 [micro]g/m\3\ to 10 [micro]g/m\3\. All other
counties in Illinois were below the NAAQS, based both on their 2010-
2012 PM2.5 design values and their recorded 2014-2016 annual
mean concentrations. Therefore, EPA expects that all counties in
Illinois will attain and maintain the PM2.5 NAAQS without
the need for additional PM2.5 reductions in Ohio.
    Ohio found, and our review confirmed, that despite the fact that
Ohio emissions potentially contribute to areas' monitored
PM2.5 air quality, all but two areas in Pennsylvania
(Allegheny and Delaware counties) were attaining the 2012 annual
PM2.5 NAAQS based on 2012-2014 data. A review of 2013-2015
design values shows that all areas except for Allegheny County have
attained the NAAQS. Our review also considers 2014-2016 design values,
which show only Allegheny and Lancaster counties not meeting the NAAQS.
    Ohio's technical analysis focused on its contribution to Allegheny
County because, in addition to being the closest county with monitored
PM2.5 air quality above the NAAQS, it has the highest design
values for the 2012 annual PM2.5 NAAQS in all of the
counties in Ohio's technical review. Ohio's technical review also
looked at its impact on PM2.5 air quality in Delaware,
Lancaster, and Lebanon counties in Pennsylvania and while its
contribution to these areas was less than for Allegheny, Ohio
identified these counties as ones it may contribute to based on the
2012 CSAPR modeling.
    EPA's review looked further into more recent and current
PM2.5 monitor data in those counties. In Delaware and
Lebanon counties, not only do the most recent PM2.5 monitor
data show these counties are attaining the PM2.5 NAAQS,
EPA's PM2.5 modeling data for 2017 and 2025 do not indicate
any nonattainment or maintenance issues in these counties. There is a
clear downward trend in PM2.5 values in these counties. For
Lancaster County, despite having a 2014-2016 design value that exceeds
the NAAQS, there is a clear downward trend in the monitored
PM2.5 air quality data that supports EPA's PM2.5
modeling that shows no nonattainment or maintenance problems for this
county by 2021.
    The modeling information contained in EPA's March 17, 2016
memorandum shows that one monitor in Alleghany County, PA (the Liberty
monitor, 420030064) may have a maintenance issue in 2017, but is
projected to both attain and maintain the NAAQS by 2025. A linear
interpolation of the

modeled design values to 2021 shows that the monitor is likely to both
attain and maintain the standard by 2021. Emissions and air quality
data trends help to corroborate this interpolation.
    Over the last decade, local and regional emissions reductions of
primary PM2.5, sulfur dioxide (SO2), and nitrogen
oxide (NOX), have led to large reductions in annual
PM2.5 design values in Allegheny County, Pennsylvania. In
2007, all of Allegheny County's PM2.5 monitors exceeded the
level of the 2012 NAAQS (the 2005-2007 annual average design values
ranged from 12.9-19.8 [micro]g/m\3\, as shown in Table 3). The 2014-
2016 annual average PM2.5 design values now show that only
one monitor (Liberty, at 12.8 [micro]g/m\3\) exceeds the health-based
annual PM2.5 NAAQS of 12.0 [micro]g/m\3\.
[GRAPHIC] [TIFF OMITTED] TP07DE17.000

    The Liberty monitor is already close to attaining the NAAQS, and
expected emissions reductions in the next four years will lead to
additional reductions in measured PM2.5 concentrations.
There are both local and regional components to the measured
PM2.5 levels in Allegheny County and the greater Pittsburgh
area. Previous CSAPR modeling showed that regional emissions from
upwind states, particularly SO2 and NOX
emissions, contribute to PM2.5 nonattainment at the Liberty
monitor. In recent years, large SO2 and NOX
reductions from power plants have occurred in Pennsylvania and states
upwind from the Greater Pittsburgh region. Ohio's submittal indicates
that Pennsylvania's energy sector emissions of SO2 will have
decreased 166,000 tons between 2015-2017 as a result of CSAPR
implementation. This is due to both the installation of emissions
controls and retirements of electric generating units (EGUs) [see the
TSD for more details]. Projected power plant closures and additional
emissions controls in Pennsylvania and upwind states will help further
reduce both direct PM2.5 and PM2.5 precursors.
Regional emission reductions will continue to occur from current on-
the-books Federal and state regulations such as the Federal on-road and
non-road vehicle programs, and various rules for major stationary
emissions sources.
    In addition to regional emissions reductions and plant closures,
additional local reductions to both direct PM2.5 and
SO2 emissions are expected to occur and should also
contribute to further declines in Allegheny County's PM2.5
monitor concentrations. For example, significant SO2
reductions have recently occurred at US Steel's integrated steel mill
facilities in southern Allegheny County as part of a 1-hr
SO2 NAAQS SIP.\2\ Reductions are largely due to declining
sulfur content in the Clairton Coke Work's coke oven gas (COG). Because
this COG is burned at US Steel's Clairton Coke Works, Irvin Mill, and
Edgar Thompson Steel Mill, these reductions in sulfur content should
contribute to much lower PM2.5 precursor emissions in the
immediate future. The Allegheny SO2 SIP also projects lower
SO2 emissions resulting from vehicle fuel standards,
reductions in general emissions due to declining population in the
Greater Pittsburgh region and several shutdowns of significant sources
of emissions in Allegheny County.
---------------------------------------------------------------------------

    \2\ http://www.achd.net/air/publichearing2017/SO2_2010_NAAQS_SIP_5-1-2017.pdf.
---------------------------------------------------------------------------

    EPA modeling projections, the recent downward trend in local and
upwind emissions reductions, the expected continued downward trend in
emissions between 2017 and 2021, and the downward trend in monitored
PM2.5 concentrations all indicate that the Liberty monitor
will attain and be able to maintain the 2012 annual PM2.5
NAAQS by 2021.
    In addition to local reductions projected to occur in Pennsylvania
discussed above, Ohio indicated that its own state-wide SO2
emissions from the energy generation sector will have decreased by
148,000 tons, or about 50 percent of its 2014 emissions, between 2015
and 2017 as a result of CSAPR implementation across Ohio. Thus, the
submittal shows that because of reductions from CSAPR implementation in
Ohio and across the CSAPR states, emissions have trended downward
nearly universally among PM2.5 air quality monitors. This
trend is reinforced by looking at air quality data since Ohio's
submittal, and by data in EPA's March 17, 2016, Memorandum.
    The conclusions of Ohio's analysis are consistent with EPA's March
17, 2016, Memorandum. All areas that Ohio sources potentially
contribute to are expected to attain and maintain the 2012
PM2.5 NAAQS by 2021. Ohio's analysis shows that through
permanent and enforceable measures currently contained in its SIP,
implementation of CSAPR from 2015-2017 and beyond, and other emissions
reductions occurring in Ohio and in other states, monitored
PM2.5 air quality in all identified areas that Ohio sources
may impact will continue to improve, and that no further measures are
necessary to satisfy Ohio's responsibilities under CAA section
110(a)(2)(D)(i)(I). Therefore, EPA is proposing that prongs one and two
of the interstate pollution transport element of Ohio's infrastructure
SIP are approvable.

IV. What action is EPA taking?

    EPA is proposing to approve a portion of Ohio's December 4, 2015,
submission certifying that the current Ohio SIP is sufficient to meet
the required infrastructure requirements under CAA section
110(a)(2)(D)(i)(I), specifically prongs one and two, as set forth
above. EPA is requesting comments on the proposed approval.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: November 17, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2017-26291 Filed 12-6-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9336-9337]
[FR Doc No: 2019-04773]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2018-0765; FRL-9990-79-OLEM]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping and Reporting--Solid Waste Disposal
Facilities and Practices

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA or Agency) is
planning to submit an information collection request (ICR),
Recordkeeping and Reporting--Solid Waste Disposal Facilities and
Practices, (EPA ICR No. 1381.12, OMB Control No. 2050-0122) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act (PRA). Before doing so, EPA
is soliciting public comments on specific aspects of the proposed
information collection as described below. This is a proposed extension
of the existing ICR, which is currently approved through August 19,
2019. A person is not required to respond to, nor an Agency may conduct
or sponsor a collection of information, unless it displays a currently
valid OMB control number.

DATES: Comments must be submitted on or before May 13, 2019.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-
2018-0765, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Craig Dufficy, Materials Recovery and
Waste Management Division, Office of Resource Conservation and
Recovery, Mail Code 5304P, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (703)
308-9037; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents detailing the
information that the EPA will be collecting are available in the public
docket for this ICR. The docket can be viewed online at:
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are required to respond,
including through the use of appropriate automated electronic,
mechanical, or other technological collection techniques or other forms
of information technology, e.g., permitting electronic submission of
responses. EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval. At that time, EPA will issue another Federal
Register notice to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB.
    Abstract: To effectively implement and enforce final changes to 40
CFR part 258 on a State level, owners/operators of municipal solid
waste landfills must comply with the final reporting and recordkeeping
requirements. Respondents include owners or operators of new municipal
solid waste

landfills (MSWLFs), existing MSWLFs, and lateral expansions of existing
MSWLFs. The respondents, in complying with 40 CFR part 258, are
required to record information in the facility operating record,
pursuant to Sec.  258.29, as it becomes available. The operating record
must be supplied to the State, as requested, until the end of the post-
closure care period of the MSWLF. The information collected will be
used by the State Director to confirm owner or operator compliance with
the regulations under Part 258. These owners or operators could include
State, Tribal, and local governments, and private waste management
companies.
    Form Numbers: None.
    Respondents/affected entities: Business or other for-profit, as
well as State, Local, and Tribal governments.
    Respondent's obligation to respond: Mandatory, see 40 CFR part
258.29.
    Estimated number of respondents: 3,800.
    Frequency of response: On occasion.
    Total estimated burden: 204,868 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $2,211,000 (per year), includes $1,831,000
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is increase of 60 hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB. This increase is due to the higher number of states adopting the
Research, Development and Demonstration (RD&D) Permits section (40 CFR
258.4) since the last ICR update.

    Dated: March 4, 2019.
Kathleen Salyer,
Acting Director, Office of Resource Conservation and Recovery.
[FR Doc. 2019-04773 Filed 3-13-19; 8:45 am]
 BILLING CODE 6560-50-P


<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="Microsoft Word - 005_Nestle.Section C - Analytical Data Regarding the Substance.doc">
<META name="creation-date" content="08/12/2009 01:54:26 ">
<TITLE>Microsoft Word - 005_Nestle.Section C - Analytical Data Regarding the Substance.doc</TITLE>

Section C:
ANALYTICAL DATA REGARDING THE SUBSTANCE
SECTION CONTENTS
Page
Introduction............................................................................................................................2
Analytical Attributes of the Substance ..................................................................................3
Protein................................................................................................................................4
Process ...............................................................................................................................5
Finished Product Characteristics........................................................................................6
Preclinical Indicators of Functionality...............................................................................8
Clinical Evidence of Functionality ..................................................................................11
Section Appendices..............................................................................................................12
Appendix C-I:  21 CFR 184.1979c - Whey Protein Concentrate
Appendix C-II:  TNBS Method for Alpha amino-Nitrogen/Total Nitrogen
Appendix C-III:  2006 Directive of the Commission of European Communities
on infant formulae and follow-on formulae
Appendix C-IV:  BLG ELISA Method
Appendix C-V:  Molecular Weight Graphs
Appendix C-VI:  Method for Peptide Profiling by SE-HPLC
Appendix C-VII:  Method for SDS-PAGE
Appendix C- VIII:  Preclinical Indicators Graphs

2
Introduction
Section 101.70(f) provides that a health claim petition should contain analytical data that
show the amount of the substance that is present “in representative foods that would be
candidates to bear the claim” and that such data “should be obtained from the representative
samples using methods from the Association of Official Analytical Chemists (AOAC), where
available.”  The section goes on to provide that if no AOAC method is available, the petition
must contain the assay method used and data establishing the validity of the method for assaying
the substance in food.
Although critical to both establishing and policing many health claims, the analytical data
requirement in the context of this Petition is somewhat anomalous in light of the fact that only
one food, infant formula, is at issue – and the amount of protein in that food is restricted within a
statutorily prescribed range (1.8 – 4.5 g/100 kcal).  In practice, this range is further narrowed by
the downward trend in current recommendations from the expert medical community.  The 1998
recommendations from an expert panel under the auspices of the Life Sciences Research
Organization were for no more than 3.4 g/100 kcal, and the international CODEX Alimentarius
“Standard for Infant Formulas and Formulas for Special Medical Purposes Intended for Infants”
(revised in 2007) allows a maximum of only 3.0 g/100 kcal.
More relevant to the claim in question is the need to assure that any 100% whey-protein
partially hydrolyzed infant formula (PHF-W), for which such a claim may be made, is consistent
with the analytical attributes of the PHF-W used in the clinical studies that support this proposed
claim. The following section discusses all those analytical attributes, as well as describing the
analytical method relied upon by Nestlé to determine the precise amount of protein.

3
Analytical Attributes of the Substance
As discussed in Section B: Summary and Systematic Evaluation of Scientific Data, a
large body of evidence supports the proposed claim regarding the link between infants’ diets
containing 100% whey-protein partially hydrolyzed infant formula and a reduction in the risk of
atopic dermatitis.  Should FDA authorize a health claim regarding this link, it goes without
saying that only formulas for which the extensive information required by FDA has been
submitted to establish their adequacy to substitute for breastmilk – and for which the agency has
thoroughly reviewed that information and found it sufficient – would be eligible to make the
claim. It is also essential that the claim be applied only to formulas that comprise the studied
substance.  The main purpose of this section of the Petition is to characterize this substance in
such a way that FDA, and manufacturers who wish to make use of such a claim, may determine
whether a given product comprises the eligible substance.
It should be noted, first of all, that all hydrolyzed formulas are not the same.  For
example, a considerable amount of data support the use of extensively hydrolyzed cow’s milk
protein in formulas (EHF) to reduce the risk of allergic disease, in addition to the therapeutic use
for which they were designed.  And, although the body of evidence on EHF for use in primary
prevention is smaller than that collected on PHF-W, EHF are already considered useful by the
medical community in reducing the risk of allergic disease in those infants identified as being at
“high risk”, based on their family history of atopic disease.  EHF formulas are, however,
“exempt” or “specialty” infant formulas, designed for use by infants having a diagnosed allergy
to cow’s milk.  As such, they are not intended for use in the general/healthy infant population –
and the much greater expense of these formulas, in addition to their lack of palatability, further
limits their use in the general population.  Since FDA-authorized health claims are intended for

4
the general population, this Petition is not intended to cover extensively hydrolyzed cow’s milk
protein in infant formulas.
Partially hydrolyzed casein/whey protein blends in infant formula (PHF-C/W) have also
been studied for use in primary prevention (Szajewska 2004, Han 2003, Oldaeus 1997).
However, only one study to date has shown a statistically significant effect on allergy prevention
(Han 2003), and the interpretation of these results is limited by the study’s short-term follow-up
(6 months).  Consequently, this Petition is not intended to cover partially hydrolyzed
casein/whey protein blends in infant formulas.
Of the total of 12 study cohorts in which data on PHF-W in atopic dermatitis prevention
have been collected, only one (Chirico 1997) used a PHF-W from another manufacturer.  All
other studies of PHF-W used Nestlé formulations.  In spite of slight variations over the years in
levels and sources of protein, processing conditions, etc., these formulations have consistently
been shown to reduce the risk of atopic dermatitis.  Thus, Nestlé proposes that the characteristics
of the substance eligible to carry the proposed claim be defined in terms of the functional
substance common to all of the Nestlé PHF-W formulations tested – i.e., a 100% whey-protein
partially hydrolyzed infant formula that is characterized by meeting all of the technical criteria
detailed in the following pages.  These criteria are discussed in order of their ease of use in
eliminating products that are not sufficiently similar to the studied formulas to justify their
carrying the proposed claim.
Protein
The first criterion for identifying an eligible infant formula product should be a
determination of the type of protein used.  The protein component in an eligible formula would

5
consist of 100% Whey Protein in accordance with the description of "Whey protein concentrate"
at 21CFR 184.1979c (attached at Appendix C-I), which may or may not be further isolated (e.g.,
to reduce mineral or lactose content) and which may or may not be fortified with additional
amino acids.  The analytical method relied upon by Nestlé to determine the amount of protein
(via total nitrogen) is equivalent to AOAC method #991.21.  However, as noted above, the
amount of protein in infant formula is already sufficiently constrained by statute and by current
medical recommendations.  What is important from the point of view of determining eligibility
for the proposed claim is that only protein in compliance with the 21CFR 184.1979c definition
be used in the manufacture of the formula. If this criterion were not met in a given product, there
would be no basis for associating that product with the clinical substantiation for this claim, and
so no additional criteria would need to be considered.
Process
Any further examination of potential eligibility should focus on the hydrolysis process.
The protein in the studied formulas was hydrolyzed by a process that includes hydrolysis of the
whey protein described above with a proteolytic enzyme to provide a first enzymatic
hydrolysate; heating the first hydrolysate for 3 to 10 minutes at a temperature of 80 degrees C to
100 degrees C at pH 6 to 8 to denature proteins remaining intact after the first hydrolysis;
cooling the heated first hydrolysate to a temperature of 40 degrees C to 60 degrees C; subjecting
the cooled first hydrolysate to hydrolysis with a proteolytic enzyme to hydrolyze the intact
denatured proteins in the first hydrolysate for providing a second hydrolysate significantly
reduced in allergens of protein origin; and then heating the second hydrolysate to thermally

6
inactivate the enzyme for providing a hydrolysate product significantly reduced in allergenic
potential.
1
Finished Product Characteristics
Only if a product met the first two criteria for eligibility, would it be necessary to go on
to confirm their similarity to the studied formulas through analysis of the end product of the
formula’s manufacture.  The typical end product resulting from this process can be described as
falling within the following ranges on the following indicators of appropriate hydrolysis:
NPN/TN %: Non-Protein Nitrogen over Total Nitrogen is widely used as a measure of
soluble protein created by enzyme hydrolysis.  In the 100% whey-protein partially hydrolyzed
infant formulas (PHF-W) used in the clinical trials discussed in this Petition, NPN/TN typically
ranges between 71 – 93%.  The analytical method used to measure NPN is equivalent to AOAC
method #991.20.  TN is determined by the method referred to above for the measurement of total
protein.
Alpha amino-N/TN %:  Alpha amino-Nitrogen over Total Nitrogen is another ratio widely
used as a measure of what is commonly referred to as “degree of hydrolysis”.  As late as 1990,
Nestlé shared with FDA its observations that its Good Start infant formula was 17.5%
hydrolyzed.  Similarly, a European patent owned by Nestlé (filed in 1996) describes the Nestlé
PHF-W formulations as 15-19% hydrolyzed.  The values seen currently in these formulas are
typically between 9 – 14 %.  The difference between the earlier values and the current ones is
due to the fact that the earlier values were measured by the “ninhydrin” method.  This same
degree of hydrolysis, as currently measured by Nestlé worldwide using the newer TNBS method,
1
This process description is adapted from Claim 1 of United States Patent Number 5,039,532 dated August 13,
1991, which expired in 2008.

7
results in a lower numerical range.  The TNBS method for measuring Alpha amino-Nitrogen
over Total Nitrogen may be found under Appendix C-II.
2
It should be noted here that, according
to the European patent, in order to induce “oral tolerance” – which is theorized to be the
mechanism by which the Nestlé PHF-W formulations reduce the risk of atopic dermatitis – it is
as important for the degree of hydrolysis not to be too high, as it is for it not to be too low.
BLG:  Nestlé tests Beta-lactoglobulin (BLG) on a regular basis, using the ELISA method,
as an indicator of total immunoreactive material. BLG constitutes somewhere between 30% -
50% of the total immunoreactive material in whey.  Thus a BLG level below 3 mg/g protein,
which is typical of the Nestlé PHF-W formulations, indicates that the product has no more than
1% immunoreactive protein.  Such a level is consistent with Annex IV of European Commission
Directive 2006/141/EC of 22 December 2006 on Infant Formulae and Follow-On Formulae
(attached at Appendix C-III, see item 2.1), which sets forth certain conditions for an infant
formula claiming to reduce the risk of allergy to milk proteins.  The second listed condition (item
(b)) is that the maximum for immunoreactive protein would be 1% of nitrogen containing
substances in the formula.
3
That is equivalent to a total of 10 mg of immunoreactive protein (as
BLG) per g nitrogen containing substance (as protein).  The analytical method Nestlé uses to
measure BLG may be found under Appendix C-IV.
Molecular Weight & Peptide Profile:  The median molecular weight of 100% whey-
protein partially hydrolyzed infant formulas (PHF-W) is typically between 1000 – 1350 Daltons.
2
The method for TN in this Nestlé laboratory instruction is referenced as LI-00.556-2, which is equivalent to AOAC
991.21
3
The second criterion requires that the product label indicate that it is not intended for use in infants allergic to
cow’s milk unless the product has been clinically proven to be tolerated by 90% of such infants.  This level of
tolerance is roughly equivalent to the AAP criterion for use of the term “hypoallergenic”.  Accordingly, any product
meeting the substance definition for this claim must be labeled as not for use in infants allergic to cow’s milk.  The
final two criteria are discussed below.

8
Attached at Appendix C-V is a graphic illustration of how PHF-W compare on this parameter
with a standard intact cow’s milk formula.  Also under Appendix C-V is a typical mean
molecular weight distribution for these PHF-W. 50% or more of the peptides have a mean
molecular weight of less than 1,500 daltons, and less than 5% of the peptides greater than 5,000
daltons.  Nestlé’s method for peptide profiling by size exclusion chromatography is enclosed at
Appendix C-VI.
Release Criteria: While the above criteria are useful in determining the general
similarity to the studied formulas, only one specific release criterion has been deemed reliable
enough to remain in effect, both globally and from the time these formulas were introduced,
among the Nestlé PHF-W demonstrated as effective in the clinical trials described in Section B:
Summary and Systematic Evaluation of Scientific Data.  This criterion requires performance
consistent with a control on a test of hydrolysis called SDS-Polyacrylamide Gel Electrophoresis
(SDS-PAGE).  This test requires a semi-quantitative visual comparison, not subject to numerical
description.  The analytical method for this test may be found under Appendix C-VII.
Preclinical Indicators of Functionality
Even where a potentially eligible formula has met all the preceding criteria, the agency
may wish to further ensure its protective effect against allergic disease through the use of some
indicator of clinical functionality.  Nestlé has found the following preclinical testing methods
useful in this regard.
As mentioned in the section above on BLG, the protein hydrolysis process used in
manufacturing PHF-W significantly reduces the immunoreactive protein content (>99%
compared to intact protein) without eliminating it completely.  And, in addition to the BLG

9
testing described above, the residual BLG-specific allergenicity has also been determined
functionally by tritiated serotonin (3H serotonin) release assay.
The level of BLG-specific IgE mediated allergenicity of PHF-W has been determined by
evaluating the capacity of this formula to trigger the release of serotonin (an allergic mediator)
from sensitized mast cells. To test this, peritoneal mast cells from normal rats were labeled with
3H serotonin and sensitized passively in vitro with a pool of rat sera containing specific IgE anti-
BLG. Then, 3H serotonin release was triggered with increasing concentrations of bovine BLG
(as a standard) or with PHF-W or intact cows’ milk protein infant formula (CMF).  The dose-
dependent response in 3H serotonin release (shown in Fig. I at Appendix C-VIII) has been
previously documented.  Significantly more PHF-W is required, on a protein equivalent basis, to
trigger similar amounts of 3H serotonin compared to CMF (Fritsché 1997).  The residual BLG-
specific allergenicity calculated based on this functional assay is 0.39% to 0.5% of that found in
CMF.  These values are consistent with the corresponding values of BLG as determined by the
ELISA method.
Using a similar animal model, consumption of PHF-W have also been demonstrated to
induce suppression of IgE antibody as well as suppression of mast cell serotonin release, as
indicators of allergic response. In other words, intake of PHF-W leads to immunomodulatory
mechanisms, which can decrease the allergic response to cow milk proteins (such as BLG) by
inducing immunologic “tolerance” to these proteins.
In these experiments, rats were orally fed either PHF-W or water (as placebo) as part of
their diet for a period of time.  Then they were sensitized, by subcutaneous administration, with
BLG, or with ovalbumin (a different unrelated protein, to assess the specificity of any

10
immunomodulation associated to the oral intake of PHF-W).  Two weeks later, specific IgE and
IgG to BLG and ovalbumin were determined by ELISA.  Fig. II (also at Appendix C-VIII) shows
that preventive oral administration of PHF-W suppresses production of anti-BLG IgE and IgG in
animals that were sensitized to BLG by injection.  Specific serum IgE and IgG antibody
production was suppressed by a factor of at least 25 (2 log5 ELISA antibody titers) compared to
IgE secretion in the control rats that were fed placebo (water) (Fritsché 1990).  In contrast,
antibody responses to ovalbumin remained unchanged when compared to the control group given
water, indicating that the suppressive, or “tolerizing” mechanism is antigen specific.
Using the same animal model, suppression of in vitro mast cell serotonin secretion has
also been studied as another way to evaluate the tolerizing capacity of PHF-W (Fritsché 1997).
Normal peritoneal mast cells were labeled with 3H serotonin and passively sensitized with the
sera of rats that had orally consumed PHF-W or water.  Then, 3H serotonin release was triggered
using increasing amounts of BLG. As expected, the mast cells from rats given water show a
dose-dependent curve of serotonin release when exposed to increasing amounts of BLG,
consistent with an allergic response.  On the other hand, the serotonin release from mast cells
sensitized with sera from rats fed PHF-W was completely blunted (see Fig. III, Appendix C-
VIII).
In summary, PHF-W not only has reduced antigenicity, as demonstrated by a reduction in
immunoreactive protein content; but in in vivo animal experiments, PHF-W leads to functional
suppression of allergic response as measured by lower IgE antibody production and suppression
of release of allergic reaction mediator (serotonin) from mast cells.  These studies suggest that
the consumption of PHF-W not only decreases the chances of allergic reaction by providing a

11
lower antigenic load, but potentially also by promoting immunologic tolerance to cow’s milk
antigens.
This data satisfies the fourth criterion (item (d)) under the EC Directive described earlier
for formulas that claim to reduce the risk of allergy to milk proteins: “the formulae administered
orally must not induce sensitization, in animals, to the intact proteins from which the infant
formulae are manufactured.”
Clinical Evidence of Functionality
The first and most important criterion (item (a)) under the EC Directive is that “Objective
and scientifically verified data as proof to the claimed properties must be available.”  By analogy
to the EC format, any product making this claim would – at a minimum – have to be shown by
“objective and scientifically verified data” to meet all of the technical characteristics described in
this Section C: Analytical Data Regarding the Substance.  In most cases, that data would
demonstrate that the formula in question was equivalent to the formulas used in the body of
scientific evidence described in Section B: Summary and Systematic Evaluation of Scientific
Data.  Since a U.S. health claim (qualified or not) must rely directly on a body of clinical
evidence such as this, the best and most direct evidence of eligibility to make this claim would,
of course, be accumulated data from several clinical trials using the potentially eligible formula -
- just as have been presented in Section B for the Nestlé PHF-W formulations described here in
Section C.

12
SECTION APPENDICES