Arizona, south New Mexico and east/southeast Texas.

July 06, 2001

On July 06, 2001, 4 sites were classified as worst dust days. At
Colombia River Gorge (CORI) the LWD to Total measured dust ratio was
40.5%. However, back trajectories did not show sustained high winds over
moderately (or highly) erodible terrain. Thus, CORI was assigned to a
windblown event.  At Bandalier (BAND) the LWD to total measured dust
ratio was ~ 6% and trajectories showed some high winds over moderately
erodible terrain. BAND was associated with windblown event .  The
information available for Nearby San Pedro (SAPE) And Gila (GICL) did
not provide any indication of the event that may have caused a worst
dust day there.).

April 03, 2003

Great Sand Dunes (GRSA), Weminuche Wilderness (WEMI), and Rocky Mountain
(ROMO) had worst dust days on April 03, 2003. For all three sites, the
event was flagged as a regional scale event since the same general flow
pattern caused all three sites to have worst dust days.

Review comment:  The Assessment of the Principal Causes of
Dust-Resultant Haze at IMPROVE Sites in the Western United States
provides a reasonable basis for the attribution of transcontinental
transport form Asia.  The techniques employed were relatively more
successful for spring events (10% of events could not be determined)
than fall (19%), winter (28%) and summer events (32%).

WRAP BART modeling

The Clean Air Act establishes the national goal of eliminating man-made
visibility impairment from all Class I areas. As a part of the plan for
achieving this goal Section 169A(b)(2)(A) of the act requires certain
major stationary sources in existence between 1962 and 1977 to be
reviewed for BART.  Pursuant to federal regulations, states have the
option of exempting a BART-eligible source from the BART requirements
based on dispersion modeling demonstrating that the source cannot
reasonably be anticipated to cause or contribute to visibility
impairment in a Class I area. According to 40 CFR Part 51, Appendix Y, a
BART eligible source is considered to “contribute” to visibility
impairment in a Class I area if the modeled 98th percentile change in
deciviews is equal to or greater than the “contribution threshold.”
Any BART-eligible source determined to cause or contribute to visibility
impairment in any Class I area is subject to BART. The EPA BART
Guidelines recommend a contribution threshold of 0.5 change in deciview
be used, although States have the option to establish alternative
thresholds.

To determine whether a source exceeds the BART contribution threshold,
EPA recommends use of the CALMET/CALPUFF modeling system; the main
components of this modeling system are CALMET (a diagnostic
three-dimensional meteorological model), CALPUFF (an air quality
dispersion model), and CALPOST (a post-processing package). Six WRAP
States (Arizona, Montana, New Mexico, Nevada, South Dakota, and Utah)
requested that the WRAP regional modeling center perform BART exemption
screening modeling to help determine whether potential BART-eligible
sources in their states contribute significantly to visibility
impairment at a Class I area. In response WRAP conducted a modeling
analysis and provided spreadsheets of Calpuff modeled 24-hour average
change in deciview from each potential BART-eligible source and each
Class I area. That CALMET/CALPUFF modeling effort is described on the
RMC and WRAP websites.  Note that in several of these States the WRAP
modeling discussed below provided a foundation for more refined or
supplemental BART–exemption modeling conducted by the individual
States. A description and evaluation of these additional modeling
analyses is contained in the individual Regional Haze SIPs submitted by
each State.

Overview of WRAP Modeling Approach

To conduct the modeling, WRAP followed the EPA BART guidelines (U.S.
EPA, 2005) and the applicable CALMET/CALPUFF modeling guidance (e.g.,
IWAQM, 1998; FLAG, 2000; EPA, 2003c) in effect at the time the analysis
was conducted. This included EPA’s March 16, 2006, memorandum
“Dispersion Coefficients for Regulatory Air Quality Modeling in
CALPUFF” (Atkinson and Fox, 2006). This memo was written by the EPA
Office of Air Quality and Planning Standards (OAQPS) Model Clearinghouse
Director in response to questions from EPA Region 4 on what constitutes
the regulatory version of CALPUFF and recommended CALPUFF options for
BART modeling in their region. The memo’s modeling recommendations are
followed in WRAP’s protocol for conducting the modeling, except as
noted below. Using the procedures in the modeling protocol, WRAP
conducted initial subject-to-BART screening analysis modeling to
determine which sources contribute significantly to visibility
impairment at Class I areas. WRAP then provided the modeling results to
the affected states, and the states used those results, in conjunction
other information, to determine whether or not the individual
BART-eligible source will be subject to BART control requirements. For
some parameters WRAP modeled multiple scenarios and deferred to the
States to select which modeled parameter is most appropriate. For
example WRAP modeled background visibility conditions corresponding to
both the 20% best visibility days and annual average visibility days.
EPA guidance allows States to select either characterization of
background conditions for their BART modeling. WRAP also provided
modeling results showing the highest 24 average change in visibility and
the 8th highest (98th percentile) predicted change. States may utilize
the maximum result if a conservative screening analysis is deemed
appropriate. The Regional Haze SIPs submitted by each State should be
reviewed to determine which of the WRAP BART modeling options was
selected for use by the State.

Model Selection and Applicability

Relevant guidance (IWAQM, 1998; FLAG 2000; EPA, 2003) states that the
CALPUFF model is generally applicable at distances from 50 km to at
least 200-300 km downwind of a source. Given the large number of Class I
areas in the West, most BART-eligible stationary sources modeled by WRAP
were located within 300 km of at least one Class I area. In some cases
where the transport distance to the nearest Class I area exceeded 300 km
the States, in consultation with EPA and the FLM’s, have conducted
supplemental analysis for their regional haze BART submittals.

The WRAP modeling was conducted using CALPUFF version 6.0. At the time
of the analysis the Calpuff regulatory version was v 5.711, however
discussions with the Federal Land Managers (FLMs) and others revealed
that this version of the model contained software bugs and that a newer
version should be used. EPA’s regulatory version has subsequently been
revised to version 5.8 which should be used in new regulatory
applications. Calpuff version 6.0 (and version 5.711) is considered
obsolete; however, it was considered appropriate at the time of the
analysis and is therefore acceptable for use in State regional haze
plans that have relied on WRAPs modeling.

Modeling Domain and Meteorology Inputs

The WRAP RMC developed a set of CALMET/CALPUFF modeling domains in the
contiguous U.S. that focus on the following states and nearby Class I
areas: Arizona, Montana, New Mexico, Nevada, South Dakota, and Utah.  In
addition, there is an Alaska CALMET/CALPUFF modeling domain.  The
dimensions of the domain were selected to include the State of interest,
plus Class I areas in nearby states, and to provide a sufficient buffer
between the Class I areas and the domain boundaries (e.g., 50 km) to
assure that CALPUFF puffs are not eliminated that may temporarily leave
the domain and later reemerge and cause visibility impacts at a Class I
area. WRAP applied CALPUFF/CALMET for each of these domains. For the
five continental-U.S. domains, WRAP used a 4-km grid and 11 vertical
layers with a Lambert conformal conic (LCC) map projection identical to
that used for the WRAP MM5 and CMAQ modeling (see Section 1.3 of the
WRAP 2002 MPE report. The CALMET modeling for these five states used MM5
meteorological data at 36-km resolution and terrain and land use data at
4-km resolution, along with surface meteorological and precipitation
observations. For the WRAP Alaska CALMET/CALPUFF modeling, a 2-km grid
was used, along with 15-km-resolution MM5 data, surface meteorological
and precipitation data, and 1-km-resolution land use and terrain data.
For CALMET modeling for the continental-U.S. states, WRAP used MM5
meteorology data for the years 2001, 2002 and 2003. EPA recommends
performing three years of CALMET/CALPUFF modeling when using MM5 data,
and 2001 through 2003 were the most recent three years with MM5 data
available at the time this modeling was initiated. For Alaska CALMET
modeling, WRAP used one year of data (2002) because only one year of
historical MM5 modeling is available.

Note that although surface meteorological and precipitation observations
were used as input to CALMET, upper-air meteorological observations were
not. EPA and the FLMs generally recommend both surface and upper air
information be blended into the CALMET modeling, although in some
applications they may be redundant to the MM5 data which already
includes the upper air data.

Emissions Input

According to the EPA BART Guidelines: “The emissions estimates used in
the models are intended to reflect steady-state operating conditions
during periods of high capacity utilization. We do not generally
recommend that emissions reflecting periods of start-up, shutdown, and
malfunction be used, as such emission rates could produce higher than
normal effects than would be typical of most facilities. We recommend
that States use the 24 hour average actual emission rate from the
highest emitting day of the meteorological period modeled, unless this
rate reflects periods start-up, shutdown, or malfunction.” (EPA,
2005).

As a first approach to identify BART eligible sources and the
appropriate modeling emission rates, WRAP used SCC-based BART
eligibility criteria and information provided by ERG, Inc., in their
report “Identification of BART-eligible Sources in the WRAP Region”
(ERG, 2006). WRAP then provided spreadsheets with this information to
the states and tribes for comment. The States/Tribes reviewed this
information along with NSR permitting and other records and determined
which sources are BART eligible. Sources determined to be BART eligible
were then generally modeled using emission estimates based on the
maximum 24 hour emission rates during the 2001-2003 meteorological
period modeled. In-stack continuous emission monitoring (CEM) data were
used where available. For sources where CEM data were not available
permitted allowable or calculated AP-42 emission rates were used. For
source specific emissions information the individual State regional haze
SIP should be consulted.

Calpuff/Calmet Model Settings

The CALMET and CALPUFF model settings used by WRAP complied with EPA’s
recommendations for regulatory application of the CALPUFF modeling
system in effect at the time of the analysis, except as noted below:

The maximum allowable mixing height (Z1MAX) for the WRAP CALMET modeling
was 4,500 m AGL, versus the EPA regulatory default of 3,000 m AGL.
Vertical temperature soundings indicate higher summertime mixing heights
are appropriate in many areas of the intermountain west.

The EPA default assumes no MM5 data will be used (IPROG=0). In the RMC
BART screening analysis, MM5 data were used as an initial-guess field
(IPROG=14).

The EPA default assumes values for IEXTRP (-4) and RMIN2 (4) that are
incompatible with each other in some of the applications and therefore
used values of 1 and 4, respectively. WRAP used the hourly 36-km MM5
data to define the upper-level winds, thus the extrapolation of the
surface wind data aloft as recommended by EPA (IEXTRP= -4) was not
needed.

WRAP set IAVET to 0 to turn off spatial averaging of the temperature
interpolation, since the MM5 temperatures are already fairly smooth.

The beginning and ending water land use categories were changed to 51
and 55, respectively, rather than using the EPA default (999) that
assumes no water land use categories.

Model Evaluation

The CALMET meteorological fields were spot-checked for reasonableness
using visualization and animation tools, but no comprehensive evaluation
was undertaken. The main inputs to CALMET are the hourly 36-km MM5 data
(15-km MM5 data for Alaska), surface meteorological and precipitation
measurements, terrain data, and land use data. The 36-km MM5 fields were
evaluated previously (McNally, 2003; Kemball-Cook et al., 2005; Baker,
2004a,b), and the terrain and land use inputs were evaluated by
comparing spatial plots of the inputs against topographic and land use
maps. The Alaska 15-km MM5 data were also evaluated (Kemball-Cook et
al., 2005). EPA has reviewed the WRAP CALMET fields for the 6 modeling
domains and found them adequate for use by States initially in BART
Calpuff modeling applications. Several States have modified the WRAP
CALMET analysis to account for site specific issues such as nearby
terrain features in their BART modeling.  The individual State regional
haze plans provide details on these modifications.

Calpuff has been evaluated nationally by EPA and is considered
appropriate for long range transport applications and no site specific
performance evaluations were performed.

Review Comment (summary of EPA comments on WRAP BART Modeling):  WRAP
conducted initial subject-to-BART screening analysis modeling for six
western States to determine which sources contribute significantly to
visibility impairment in Class I areas. The overall approach followed
EPA guidance and modeling procedures in effect at the time of the
analysis and is therefore acceptable for use in the current regional
haze plans. In several of these States the WRAP modeling provided a
foundation for more refined or supplemental BART–exemption modeling
conducted by the individual States. A description and evaluation of
these additional modeling analyses is contained in the individual
Regional Haze SIPs submitted by each State.

Conclusions

The technical work of the WRAP was consistent with the best practices
and science at the time it was performed. It is appropriate for the
western states to use it as the basis for complying with the
requirements of the Regional Haze Rule.

The EPA’s evaluation of the WRAPs work is summarized below, organized
by topic area.

A. Baseline Visibility Conditions

The WRAP followed EPA guidance in developing the baseline visibility
conditions for the Class I areas in their region. They appropriately
extended EPA-recommended methods in some cases in order to ensure a
sufficiently large data set for determining baseline conditions.

B. Natural Visibility Conditions

WRAP used a refined method to estimate natural visibility conditions.
The states are able to do this under the rule. WRAP’s method matches
EPA’s general approach, but is more refined and statistically
sophisticated than the default EPA procedure.

C. Source Contribution to Haze

PM Source Apportionment Technology Analysis:  The PSAT analysis provides
useful qualitative information about source contributions to visibility
impairment. It is appropriate for states to consider the results of this
analyses in their reasonable progress demonstrations.

Weighted Emissions Potential Analysis:  The Weighted Emissions Potential
analysis is a simple integration of emissions and wind data. It is
potentially useful as a screening tool, but has a number of limitations.
It should be used only in conjunction with other methods.

Organic Aerosol Tracer Analysis:  The organic aerosol tracer analysis
made a good case for the fact that there is a significant amount of
uncontrollable, organic aerosols contributing to haze in the West.
However, further analysis would be required in order to use this
knowledge to change assumptions about natural conditions or to make the
case that it is unreasonable to further control anthropogenic organic
aerosols.

Positive Matrix Factorization analysis:  The positive matrix
factorization analysis is useful for identifying source categories
impacting class one areas as long as those source categories were
evaluated in the analysis.

Causes of Dust Analysis:  The Causes of Dust Analysis provides a
reasonable account of transcontinental transport of dust. The techniques
were more successful for spring events than other times of the year. If
a particular Class I area is significantly impacted by coarse mass, this
analysis could be useful it characterizing the extent to which those
coarse mass impacts are controllable by the state.

D. Reasonable Progress Goals.

The reasonable progress goals are based on the WRAP’s projection of
visibility impairment at Class I areas in 2018. This projection is
derived from the results of the visibility modeling. The visibility
modeling depends on the meteorological modeling and the emissions
inventory.

Emissions Inventory:  The emissions inventory was completed in
accordance with EPA guidance and the final versions of the 2002 and 2018
inventories were complete, recent and accurate. The inventories should
be adequate for all of the Class I areas covered by the WRAP analysis.

Meteorological Modeling:  The meteorological model and methodology used
by WRAP was state-of-the-science at the time the modeling was conducted.
The performance of the model was adequate for use in developing the
reasonable progress goals. For future modeling, additional attention
should be paid to performance in the desert southwest. The performance
of the model could be further improved for this area.

Visibility Modeling:  The visibility model and methodology used by WRAP
was state-of-the-science at the time the modeling was conducted. The
performance of the model was adequate for use in developing the
reasonable progress goals. For future modeling, the performance should
be analyzed at the geographic sub-region level. Evaluating performance
over such a large area can mask performance problems at particular Class
1 areas. Any sub-region performance analysis should examine the effects
of any remaining performance concerns with the meteorological modeling.
Given the the broad geographic scope in the emissions inventories and of
the model performance analysis, a more detailed analysis of the model
performance and relevant emissions inventory source categories may be
required for some Class I areas.

Appendix: Accessing WRAP Technical Products

The following text in italics is the executive summary of a document
created by WRAP titled “TSS Roadmap and Users Guide”.  The WRAP
Technical Support System (TSS) is publically accessible over the
internet and is the primary method WRAP uses to convey technical
products to State and Tribes in support of their RH SIP development
efforts.

The Western Regional Air Partnership‘s (WRAP) Technical Support System
(TSS) is intended to present and disseminate technical regional haze
planning results for the 116 Class I areas in the WRAP region on an
ongoing basis, identify associated technical data and analysis products
and resources, and describe how these data and results were derived and
relate to one another.  The TSS presents air quality indicators for
regional haze using a “weight-of-evidence” approach as suggested in
EPA guidance – monitoring, emissions, source apportionment, and
visibility modeling results.  The TSS data displays and analysis results
are formatted to comply with the metrics and specific requirements in
the EPA Regional Haze Rule (RHR) and are being used by states and EPA
regional offices in the WRAP region, in the technical support documents
for State or Federal Implementation Plans (SIPs and FIPs) required for
each Class I areas under the RHR.  The methodologies for technical data
collection and processing, quality assurance and control, and analysis
activities are documented on the TSS.

Much of the data and regional analysis results on the TSS are also
suitable, and have been used for other air quality analysis and planning
purposes, because they were developed at the direction of, and through
the collaborative committee and workgroup efforts within the WRAP
organization.  A significant amount of more detailed data and/or
analysis results also exist in data support systems (VIEWS. EDMS, FETS)
or separate projects (RMC, CoHA), all of which support the TSS summary
data developed to support RHR air quality planning.  These systems or
projects are listed, described, and linked to on the Projects section of
the TSS.  Also, many related reports for specific source sectors,
analysis of regional impacts to Class I areas, and control strategy
analyses are found under individual Committees, Forums, and Workgroups
on the WRAP website – access to these results are generally not found
on the TSS due to their geographic- and/or source-specific nature, and
may be applied by the appropriate regulatory jurisdiction for RHR
planning as that agency wishes.  This version of the WRAP website moved
into archive status in early 2010, but the links will remain accessible.

On the TSS under the “Home” section, links to administrative and
reference information are provided to assure feedback to keep the TSS
current.  Under the “Resources” section, descriptions,
documentation, and access to tools and data are provided, for the Haze
Planning, Monitoring, Emissions, Modeling, and Apportionment results
required in a State or Federal Implementation Plan under the Regional
Haze Rule, as well as the subsequent implementation of those plans.

Required Technical Elements on TSS for Regional Haze Implementation
Plans

Monitored baseline visibility conditions (2000-04) for each Class I
area, plus subsequent data

Natural conditions estimates for each Class I area (2064 target)

Uniform glide slope for each Class I area

Baseline emissions (2000-2004)

Projected 2018 emissions

Source apportionment at each Class I area for 2000-04 baseline and 2018
projections

Projected 2018 visibility conditions at each Class I area

The “Projects” section of the TSS provides brief descriptions of the
data systems and projects, and links to the more detailed and voluminous
results found in each system or project.  Finally, the “Partners”
section provides links to the team behind the TSS, including
descriptions of their expertise and experience.

All data visualization and analysis tools on the TSS have integrated
access to “Help” for the user, via the master TSS “Getting
Started” document, an HTML page.  The Monitoring, Emissions, Modeling,
and Source Apportionment subsections contain detailed “Methods”
descriptions, identifying how datasets and analysis tools were prepared
and how they are used on the TSS.

  HYPERLINK "http://www.epa.gov/air/caa/" http://www.epa.gov/air/caa/

  HYPERLINK "http://www.epa.gov/air/visibility/regional.html" \l
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http://www.epa.gov/air/visibility/regional.html#thefive#thefive

  HYPERLINK
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 EPA, 2003, Guidance for Tracking Progress Under the Regional Haze Rule,
EPA-454/B-03-004, September 2003, EPA OAQPS; web page:  HYPERLINK
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http://www.epa.gov/ttn/oarpg/t1pgm.html

direct link:  HYPERLINK
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http://www.epa.gov/ttn/oarpg/t1/memoranda/rh_tpurhr_gd.pdf

 EPA, 2003, Guidance for Estimating Natural Visibility Conditions Under
the Regional Haze Program, EPA-454/B-03-005, September 2003, EPA OAQPS;
web page:  HYPERLINK "http://www.epa.gov/ttn/oarpg/t1pgm.html"
http://www.epa.gov/ttn/oarpg/t1pgm.html

direct link:  HYPERLINK
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direct link:  HYPERLINK
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http://vista.cira.colostate.edu/improve/Publications/NewsLetters/IMPNews
4thQtr2005.pdf

 "WRAP IMPROVE Data Substitutions", April 3, 2007;

web page:  HYPERLINK
"http://vista.cira.colostate.edu/TSS/Results/Monitoring.aspx"
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 "Natural Haze Levels II: Application of the New IMPROVE Algorithm to
Natural Species Concentrations Estimates; Final Report by the Natural
Haze Levels II Committee to the RPO Monitoring/Data Analysis Workgroup",
presentation at WRAP Attribution of Haze Workgroup Meeting, July 26-27,
2006, Denver, CO. web page:  HYPERLINK
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ature.htm"
http://vista.cira.colostate.edu/improve/Publications/GrayLit/gray_litera
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lCondII/naturalhazelevelsIIreport.ppt"
http://vista.cira.colostate.edu/improve/Publications/GrayLit/029_Natural
CondII/naturalhazelevelsIIreport.ppt

 EPA’s MOBILE6 model is available at  HYPERLINK
"http://www.epa.gov/OMSWWW/m6.htm" http://www.epa.gov/OMSWWW/m6.htm .

 The final version of NONROAD (NONROAD2005, available at  HYPERLINK
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http://www.epa.gov/otaq/nonrdmdl.htm ) was released after the work in
this project was completed.

 National Mobile Inventory Model is available at  HYPERLINK
"http://www.epa.gov/OMSWWW/nmim.htm" http://www.epa.gov/OMSWWW/nmim.htm
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 Pollack, A.K., R. Chi, C. Lindhjem, C. Tran, P. Chandraker., P.
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 “Emissions Modeling” at
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 Prb18b specification at
http://pah.cert.ucr.edu/aqm/308/spec_sheets/SpecSheet_PRP18b_Aug11_2009f
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 Kemball-Cook, S., Y. Jia, C. Emery, R. Morris, Z. Wang and G. Tonnesen.
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 A list of the run segments and their date/time durations is provided at
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http://pah.cert.ucr.edu/aqm/308/2002met/mm5/2002_MM5_dateskey_UCR.xls

  HYPERLINK
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oc"
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c

  HYPERLINK "http://www.cmascenter.org/" http://www.cmascenter.org/

  HYPERLINK
"http://pah.cert.ucr.edu/aqm/308/reports/final/2002_MPE_report_main_body
_FINAL.pdf"
http://pah.cert.ucr.edu/aqm/308/reports/final/2002_MPE_report_main_body_
FINAL.pdf

 U.S. EPA. 2001. “Guidance for Demonstrating Attainment of Air Quality
Goals for PM2.5 and Regional Haze”, Draft Report, U.S. Environmental
Protection Agency, Research Triangle Park, NC.

 U.S. EPA. 2003a. “Guidance for Estimating Natural Visibility
Conditions under the Regional Haze Rule.” EPA-454/B-03-005. September
2003

 U.S. EPA. 2006. Guidance on the Use of Models and Other Analyses for
Demonstrating Attainment of Air Quality Goals for Ozone, Pm2.5, and
Regional Haze – Draft 3.2. U.S. Environmental Protection Agency,
Office of Air Quality and Planning Standards, Research Triangle Park,
North Carolina. September. ( HYPERLINK
"http://www.epa.gov/scram001/guidance/guide/draft_final-pm-O3-RH.pdf"
http://www.epa.gov/scram001/guidance/guide/draft_final-pm-O3-RH.pdf ).

 U.S. EPA. 2003b. “Guidance for Tracking Progress under the Regional
Haze Rule.” U.S. EPA, EPA-454/B-03-004. September 2003.

 ENVIRON. 2006. “User’s Guide – Comprehensive Air-quality Model
with extensions, Version 4.30.” ENVIRON International Corporation,
Novato, California. (available at  HYPERLINK "http://www.camx.com"
http://www.camx.com ).

 http://vista.cira.colostate.edu/docs/wrap/attribution/PSATMethods.doc

 available at  HYPERLINK
"http://vista.cira.colostate.edu/TSS/Results/SA.aspx"
http://vista.cira.colostate.edu/TSS/Results/SA.aspx

 Morris, R.E., G.Y., C.E., G.W., B.K. 2005. “Recent Advances in
One-Atmospheric Modeling Using the Comprehensive Air-quality Model with
Extensions.” Presented at the 98th Annual Air and Waste Management
Conference, Minneapolis, MN. June.

 Yarwood, G., R.E. Morris, G. Wilson. 2004. “Particulate Matter Source
Apportionment Technology (PSAT) in the CAMx Photochemical Grid Model."
Presented at the ITM 27th NATO Conference- Banff Centre, Canada,
October.

  HYPERLINK
"http://vista.cira.colostate.edu/docs/wrap/attribution/WEPMethods.doc"
http://vista.cira.colostate.edu/docs/wrap/attribution/WEPMethods.doc

  HYPERLINK "http://pah.cert.ucr.edu/aqm/308/"
http://pah.cert.ucr.edu/aqm/308/

  HYPERLINK "http://coha.dri.edu/index.html"
http://coha.dri.edu/index.html

 Further information regarding the Organic Aerosol Tracer analysis
technique can be found in the TSS document   HYPERLINK
"http://pah.cert.ucr.edu/aqm/308/reports/final/2006/WRAP-RMC_2006_report
_FINAL.pdf"
http://pah.cert.ucr.edu/aqm/308/reports/final/2006/WRAP-RMC_2006_report_
FINAL.pdf , page 73.

 Further information regarding the PMF analysis can be found on the CoHA
web site  HYPERLINK
"http://www.coha.dri.edu/web/general/tools_PMFModeling.html"
http://www.coha.dri.edu/web/general/tools_PMFModeling.html .

 Further information regarding the Causes of Dust analysis can be found
on the CoHA web site  HYPERLINK
"http://www.coha.dri.edu/dust/index.html"
http://www.coha.dri.edu/dust/index.html .

 Cheng, TT, Lu, DR, Wang, GC, Xu, YF. Chemical characteristics of Asian
dust aerosol from Hunshan Dake sandland in Northern China. Atmospheric
Environment, 2005. 2903-2911

 Park, SU, Chang, LS, Lee, EH. Direct radiative forcing due to aerosols
in East Asia during a Hwangsa(Asian dust) event observed on 19-23 March
2002 in Korea. Atmospheric Environment, 2005, 2593-2606

 Zhang, RJ, Arimoto, R, An, JL, Yabuki, S, Sun, JH. Ground observations
of a strong dust storm in Beijing in March 2002. Journal of Geophysical
Research, 2005, D18S06

 Darmenova, K, Sokolik, IN, Darmenov, A. Characterization of east Asian
dust outbreaks in the spring of 2001 using ground-based and satellite
data. Journal of Geophysical Research, 2005 D02204

 Perry KD, Cahill TA, Eldred RA, Dutcher DD, Gill T, 1997, Long-range
transport of North African dust to the eastern United States Journal of
Geophysical Research 102 (D10): 11225-11238

 VanCuren RA, Cahill TA Title: Asian aerosols in North America:
Frequency and concentration of fine dust. Journal of Geophysical
Research 107 (D24): Art. No. 4804 DEC 28 2002

  HYPERLINK "http://pah.cert.ucr.edu/aqm/308/bart.shtml"
http://pah.cert.ucr.edu/aqm/308/bart.shtml

  HYPERLINK
"http://pah.cert.ucr.edu/aqm/308/reports/final/2006/WRAP-RMC_2006_report
_FINAL.pdf"
http://pah.cert.ucr.edu/aqm/308/reports/final/2006/WRAP-RMC_2006_report_
FINAL.pdf

  HYPERLINK
"http://pah.cert.ucr.edu/aqm/308/bart/WRAP_RMC_BART_Protocol_Aug15_2006.
pdf"
http://pah.cert.ucr.edu/aqm/308/bart/WRAP_RMC_BART_Protocol_Aug15_2006.p
df

 Interagency Workgroup on Air Quality Modeling (IWAQM) Phase 2 Summary
Report and Recommendations for Modeling Long Range Transport Impacts
(EPA-454/R-98-019)

  HYPERLINK "http://www.nature.nps.gov/air/Pubs/pdf/flag/FlagFinal.pdf"
http://www.nature.nps.gov/air/Pubs/pdf/flag/FlagFinal.pdf

 EPA. 2003. “Revisions to the Guideline on Air Quality Models:
Adoption of a Preferred Long Range Transport Model and Other
Resources”; Final Rule. Fed. Reg./Vol. 68, No. 72/Tuesday April 15,
2003/Rules and Regulations. 40 CFR51.

  HYPERLINK "http://pah.cert.ucr.edu/aqm/308/docs.shtml"
http://pah.cert.ucr.edu/aqm/308/docs.shtml

 EPA. 2005. “Regional Haze Regulations and Guidelines for Best
Available Technology (BART) Determinations”. Fed. Reg./Vol. 70, No.
128/Wed. July 6, 2005, Rules and Regulations, pp. 39104-39172. 40 CFR
Part 51, FRL-7925-9, RIN AJ31.

 ERG, Inc., 2006: Identification of BART-eligible Sources in the WRAP
Region, Draft Report. Prepared for the Western Regional Air Partnership
by ERG, Inc., Sacramento, CA. April 4, 2006

 McNally, D.E. 2003. Annual Application of MM5 for Calendar Year 2001.
Prepared for U.S. EPA, Office of Air Quality and Planning Standards.
Prepared by Alpine Geophysics, Arvada, CO.

 Kemball-Cook, S., Y. Jia, C. Emery and R. Morris. 2005. Alaska MM5
Modeling for the 2002 Annual Period to Support Visibility Modeling.
Western Regional Air Partnership, Regional Modeling Center.

 Baker, K. 2004a. Summer MM5 Performance. Midwest Regional Planning
Organization.

 Baker, K. 2004b. Monthly Rainfall Evaluation. Midwest regional Planning
Organization.

  HYPERLINK "http://www.wrapair2.org/" http://www.wrapair2.org/

  HYPERLINK "http://vista.cira.colostate.edu/tss/"
http://vista.cira.colostate.edu/tss/

  HYPERLINK "http://www.wrapair.org/RH_Rule_P51/index.html"
http://www.wrapair.org/RH_Rule_P51/index.html

  HYPERLINK "http://views.cira.colostate.edu/web/"
http://views.cira.colostate.edu/web/

  HYPERLINK "http://www.wrapedms.org/" http://www.wrapedms.org/

  HYPERLINK "http://www.wrapfets.org/" http://www.wrapfets.org/

  HYPERLINK "http://pah.cert.ucr.edu/aqm/308/"
http://pah.cert.ucr.edu/aqm/308/

  HYPERLINK "http://www.coha.dri.edu/" http://www.coha.dri.edu/

**** DRAFT 10/4/2010 ****

 PAGE

 PAGE   58

**** DRAFT ****


[Federal Register Volume 88, Number 125 (Friday, June 30, 2023)]
[Notices]
[Pages 42375-42376]
[FR Doc No: 2023-13884]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1096]

Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for
Treatment; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Chronic
Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.'' The
purpose of this guidance is to assist sponsors in the development of
drugs or biological products for the treatment of chronic
rhinosinusitis with nasal polyps (CRSwNP). Specifically, this guidance
addresses FDA's current thinking regarding trial population and design,
effectiveness, statistical analysis, and safety for drugs being
developed for the treatment of CRSwNP. This guidance finalizes the
draft guidance of the same title issued on December 10, 2021.

DATES: The announcement of the guidance is published in the Federal
Register on June 30, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-1096 for ``Chronic Rhinosinusitis With Nasal Polyps:
Developing Drugs for Treatment.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Rekha Jhamnani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3395, Silver Spring, MD 20993-0002, 301-
796-5636; or Diane Maloney, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs
for Treatment.'' The guidance provides recommendations for sponsors
developing products for the treatment of CRSwNP. Specifically, this
guidance represents FDA's current thinking regarding trial population
and design, effectiveness, statistical analysis, and safety for drugs
being developed for the treatment of CRSwNP. This guidance does not
address the clinical development of drugs for the treatment

of chronic rhinosinusitis without nasal polyps or allergic fungal
rhinosinusitis.
    This guidance finalizes the draft guidance of the same title issued
on December 10, 2021 (86 FR 70505). FDA considered comments received on
the draft guidance in this finalized guidance. Chronic rhinosinusitis
is characterized by inflammation of the nasal mucosa and paranasal
sinuses and can be further divided into chronic rhinosinusitis with and
without nasal polyps. Nasal polyps are inflammatory hyperplastic
growths that protrude into the nasal passages. Symptoms of CRSwNP
include nasal congestion, nasal discharge, facial pain or pressure, and
loss of smell. Nasal polyps have associated morbidity that can have
substantial impact on day-to-day functioning. Because of differences in
natural history and treatment between chronic rhinosinusitis with and
without nasal polyps, this guidance specifically addresses aspects of
trial design, safety and efficacy assessment for CRSwNP. Changes from
the draft to the final guidance include considerations for efficacy
assessments for CRSwNP.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Chronic Rhinosinusitis With Nasal Polyps:
Developing Drugs for Treatment.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information contained in 21 CFR part 312 relating to investigational
new drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 relating to new
drug applications have been approved under OMB control number 0910-
0001. The collections of information contained in 21 CFR part 601
relating to biologics license applications have been approved under OMB
control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13884 Filed 6-29-23; 8:45 am]
BILLING CODE 4164-01-P


5
                                                                              0
                                                                              0
2016
                                                                              0
                                                                           21.7
                                                                           0.32
                                                                              0
                                                                              5
                                                                              0
                                                                              0
2017
                                                                              0
                                                                           21.7
                                                                           0.26
                                                                              0
                                                                              5
                                                                              0
                                                                              0
2018
                                                                              0
                                                                           21.7
                                                                           0.21
                                                                              0
                                                                              5
                                                                              0
                                                                              0
2019
                                                                              0
                                                                           21.7
                                                                           0.16
                                                                              0
                                                                              5
                                                                              0
                                                                              0
2020
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                              8
                                                                              0
                                                                              0
2021
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                            7.5
                                                                              0
                                                                              0
2022
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                            6.6
                                                                              0
                                                                              0
2023
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                            5.8
                                                                              0
                                                                              0
2024
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                              5
                                                                              0
                                                                              0
2025
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                            4.2
                                                                              0
                                                                              0
2026
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                            3.3
                                                                              0
                                                                              0
2027
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                            2.5
                                                                              0
                                                                              0
2028
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                            1.6
                                                                              0
                                                                              0
2029
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                            0.8
                                                                              0
                                                                              0
2030
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                              0

                     Calendar-Year HCFC Consumption Allowances
                                Control Period
                             Percent of HCFC-141b
                              Percent of HCFC-22
                             Percent of HCFC-142b
                              Percent of HCFC-123
                              Percent of HCFC-124
                             Percent of HCFC-225ca
                             Percent of HCFC-225cb
2003
                                                                              0
                                                                            100
                                                                            100
                                                                            -
                                                                            -
                                                                            -
                                                                            -
2004
                                                                              0
                                                                            100
                                                                            100
                                                                            -
                                                                            -
                                                                            -
                                                                            -
2005
                                                                              0
                                                                            100
                                                                            100
                                                                            -
                                                                            -
                                                                            -
                                                                            -
2006
                                                                              0
                                                                            100
                                                                            100
                                                                            -
                                                                            -
                                                                            -
                                                                            -
2007
                                                                              0
                                                                            100
                                                                            100
                                                                            -
                                                                            -
                                                                            -
                                                                            -
2008
                                                                              0
                                                                            100
                                                                            100
                                                                            -
                                                                            -
                                                                            -
                                                                            -
2009
                                                                              0
                                                                            100
                                                                            100
                                                                            -
                                                                            -
                                                                            -
                                                                            -
2010
                                                                              0
                                                                           41.9
                                                                           0.47
                                                                            125
                                                                            125
                                                                            125
                                                                            125
2011
                                                                              0
                                                                             32
                                                                            4.9
                                                                            125
                                                                            125
                                                                            125
                                                                            125
2012
                                                                              0
                                                                           17.7
                                                                            4.9
                                                                            125
                                                                            125
                                                                            125
                                                                            125
2013
                                                                              0
                                                                             18
                                                                            4.9
                                                                            125
                                                                            125
                                                                            125
                                                                            125
2014
                                                                              0
                                                                           14.2
                                                                            4.9
                                                                            125
                                                                            125
                                                                            125
                                                                            125
2015
                                                                              0
                                                                              7
                                                                            1.7
                                                                            100
                                                                            8.3
                                                                              0
                                                                              0
2016
                                                                              0
                                                                            5.6
                                                                            1.5
                                                                            100
                                                                            8.3
                                                                              0
                                                                              0
2017
                                                                              0
                                                                            4.2
                                                                            1.2
                                                                            100
                                                                            8.3
                                                                              0
                                                                              0
2018
                                                                              0
                                                                            2.8
                                                                              1
                                                                            100
                                                                            8.3
                                                                              0
                                                                              0
2019
                                                                              0
                                                                            1.4
                                                                            0.7
                                                                            100
                                                                            8.3
                                                                              0
                                                                              0
2020
                                                                              0
                                                                              0
                                                                              0
                                                                           32.3
                                                                              8
                                                                              0
                                                                              0
2021
                                                                              0
                                                                              0
                                                                              0
                                                                           29.0
                                                                            7.5
                                                                              0
                                                                              0
2022
                                                                              0
                                                                              0
                                                                              0
                                                                           25.8
                                                                            6.6
                                                                              0
                                                                              0
2023
                                                                              0
                                                                              0
                                                                              0
                                                                           22.6
                                                                            5.8
                                                                              0
                                                                              0
2024
                                                                              0
                                                                              0
                                                                              0
                                                                           19.4
                                                                              5
                                                                              0
                                                                              0
2025
                                                                              0
                                                                              0
                                                                              0
                                                                           16.1
                                                                            4.2
                                                                              0
                                                                              0
2026
                                                                              0
                                                                              0
                                                                              0
                                                                           12.9
                                                                            3.3
                                                                              0
                                                                              0
2027
                                                                              0
                                                                              0
                                                                              0
                                                                            9.7
                                                                            2.5
                                                                              0
                                                                              0
2028
                                                                              0
                                                                              0
                                                                              0
                                                                            6.5
                                                                            1.6
                                                                              0
                                                                              0
2029
                                                                              0
                                                                              0
                                                                              0
                                                                            3.2
                                                                            0.8
                                                                              0
                                                                              0
2030
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                              0
                                                                              0
      * * *
      (e)(1) Effective January 1, 2020, no person may produce HCFC-22 or HCFC-142b for any purpose other than for use in a process resulting in their transformation or their destruction, for export under §82.18(a) using unexpended Article 5 allowances, or for exemptions permitted in §82.15(f). Effective January 1, 2020, no person may import HCFC-22 or HCFC-142b for any purpose other than for use in a process resulting in their transformation or their destruction, or for exemptions permitted in §82.15(f).
      (2) Effective January 1, 2020, no person may produce HCFC-123 for any purpose other than for use in a process resulting in its transformation or its destruction, for use as a refrigerant in equipment manufactured before January 1, 2020, for export under §82.18(a) using unexpended Article 5 allowances, or for exemptions permitted in §82.15(f). Effective January 1, 2020, no person may import HCFC-123 for any purpose other than for use in a process resulting in its transformation or its destruction, for use as a refrigerant in equipment manufactured before January 1, 2020, for use as a fire suppression streaming agent in equipment manufactured before January 1, 2020 listed as acceptable for use or acceptable subject to narrowed use limits for nonresidential applications, or for exemptions permitted in §82.15(f).
* * * * *

11. Amend section 82.23 by
a. removing and reserving paragraph (a)(i)(F); and
b. adding paragraph (b)(1)(i).
Revisions to read as follows:
§82.23 Transfers of allowances of class II controlled substances.
	(a) * * *
	(i) * * *
      (F) [Reserved]
* * * * *
	(b) * * *
	(1) * * *
      (i) Effective January 1, 2020, a person (transferor) may only convert allowances for one class II controlled substance for which EPA has issued allowances under §82.16 to another class II controlled substance for which EPA has issued allowances under §82.16.
* * * * *

13. Amend section §82.24 by:
a. revising paragraphs (a)(1); (b)(2)(iv); (c)(3)(i)-(iii), (vi), (viii)-(xiii); (c)(4)(i)(A); (c)(4)(vii); and (d)(1);
b. removing and reserving paragraphs (b)(1)(iv), (ix), and (xi); (b)(2)(xii) and (xiv); (c)(1)(vi) and (xi); (c)(2)(xvi); (c)(4)(v); (c)(4)(vii); (d)(2); and (g);
c. adding paragraphs (c)(6)-(10).
Revisions to read as follows:
§82.24   Recordkeeping and reporting requirements for class II controlled substances.
      (a) * * *
      (1) Reports required by this section must be submitted to the Administrator within 45 days of the end of the applicable reporting period, unless otherwise specified. Effective April 1, 2020, reports that are available for submission through the Central Data Exchange must be submitted electronically through that tool.
* * * * *
      (b) * * *
      (1) * * *
      (iv) [Reserved]
      * * *
      (ix) [Reserved]
      * * *
      (xi) [Reserved]
      (2) * * *
      (iv) Dated records of the quantity (in kilograms) of class II controlled substances produced with Article 5 allowances;
      * * *
	(xii) [Reserved]
      * * *
      (xiv) [Reserved]
* * * * *
      (c) * * *
      (1) * * *
      (vi) [Reserved]
      * * *
      (xi) [Reserved]
      (2) * * *
      (xvi) [Reserved]
      (3) * * *
      (i) The name, commodity code and quantity (in kilograms) of the used class II controlled substance to be imported;
      (ii) The name and address of the importer, the importer ID number, the contact person, email address, and phone number;
      (iii) Name, address, contact person, email address, and phone number of all previous source facilities from which the used class II controlled substance was recovered;
      * * *
      (vi) Name, address, contact person, email address, and phone number of the exporter and of all persons to whom the material was transferred or sold after it was recovered from the source facility;
      * * *
      (viii) A description of the intended use of the used class II controlled substance, and, when possible, the name, address, contact person, email address, and phone number of the ultimate purchaser in the United States;
      (ix) The name, address, contact person, email address, and phone number of the U.S. reclamation facility, where applicable;
      (x) If someone at the source facility recovered the class II controlled substance from the equipment, the name, email address, and phone number of that person;
      (xi) If the imported class II controlled substance was reclaimed in a foreign Party, the name, address, contact person, email address, and phone number of any or all foreign reclamation facility(ies) responsible for reclaiming the cited shipment;
      (xii) An English translation of an export license, or application for an export license, from the appropriate government agency in the country of export and, if recovered in another country, the export license from the appropriate government agency in that country, and quantity authorized for export in kilograms on the export license(s);
      (xiii) If the imported used class II controlled substance is intended to be sold as a refrigerant in the U.S., the name, address, and email address of the EPA-certified U.S. reclaimer who will bring the material to the standard required under subpart F of this part, if not already reclaimed to those specifications.
      (4) * * *
      (i) * * *
      (A) If the Administrator determines that the information is insufficient, that is, if the petition lacks or appears to lack any of the information required under paragraph (c)(3) of this section or other information that may be requested during the review of the petition necessary to verify that the controlled substance is used;
* * * * *
      (vii) A person receiving the non-objection notice is permitted to import the individual shipment only within one year of the date stamped on the non-objection notice.
* * * * *
      (6) Certification of Intent to Import for Destruction. For each individual shipment of a class II controlled substance imported with the intent to destroy that substance, an importer must submit electronically to the Administrator, at least 30 working days before the shipment is to leave the foreign port of export, the following information:
      (i) Name, commodity code, and quantity in kilograms of each controlled substance to be imported,
      (ii) Name and address of the importer, the importer ID number, and the contact person's name, email address, and phone number;
      (iii) The U.S. port of entry for the import, the expected date of shipment and the vessel transporting the chemical. If at the time of submitting the certification of intent to import for destruction the importer does not know the U.S. port of entry, the expected date of shipment and the vessel transporting the chemical, and the importer receives a non-objection notice for the individual shipment in the petition, the importer is required to notify the Administrator of this information prior to the U.S. entry of the individual shipment;
      (iv) Name, address, contact person, email address, and phone number of the responsible party at the destruction facility;
      (v) An English translation of an export license, or application for an export license, from the appropriate government agency in the country of export, and quantity authorized for export in kilograms on the export license(s);
      (vi) A certification of accuracy of the information submitted in the certification.
      (7) For each individual shipment of a class II controlled substance imported with the intent to destroy that substance, an importer must submit to the Administrator a copy of the destruction verification within 30 days after destruction of the controlled substance(s).
      (8) (i) Starting on the first working day following receipt by the Administrator of a certification of intent to import a class II controlled substance for destruction, the Administrator will initiate a review of the information submitted under paragraph (c)(6) of this section and take action within 30 working days to issue either an objection-notice or a non-objection notice for the individual shipment to the person who submitted the certification of intent to import the class II controlled substance for destruction.
      (ii) The Administrator may issue an objection notice if the petition lacks or appears to lack any of the information required under this subparagraph or for the reasons listed in §82.24(c)(4)(i)(B)-(E).
      (iii) In cases where the Administrator does not object to the petition, the Administrator will issue a non-objection notice.
      (iv) To pass the approved class II controlled substances through U.S. Customs, the non-objection notice issued by EPA must accompany the shipment through U.S. Customs.
      (v) If for some reason, following EPA's issuance of a non-objection notice, new information is brought to EPA's attention which shows that the non-objection notice was issued based on false information, then EPA has the right to:
      (A) Revoke the non-objection notice;
      (B) Pursue all means to ensure that the class II controlled substance is not imported into the U.S.; and
      (C) Take appropriate enforcement actions.
      (9) A person receiving the non-objection notice is permitted to import the individual shipment only within one year of the date stamped on the non-objection notice.
      (10) A person receiving a non-objection notice from the Administrator for a certification of intent to import class II controlled substances for destruction must maintain the following records:
      (i) a copy of the certificate of intent to import for destruction;
      (ii) the EPA non-objection notice;
      (iii) a copy of the export license or export license application;
      (iv) U.S. Customs entry documents for the import that must include one of the commodity codes from Appendix K to this subpart;
      (v) the date, amount, and type of controlled substance sent for destruction, per shipment;
      (vi) an invoice from the destruction facility verifying the shipment was received; and
	(vii) a copy of the destruction verification from the destruction facility.
	(d) * * *
	(1) Reporting -- Exporters. For any exports of class II controlled substances not reported under paragraph (b)(2) of this section (reporting for producers of class II controlled substances), each exporter who exported a class II controlled substance must submit to the Administrator the following information within 30 days after the end of each quarter in which the unreported exports left the U.S.:
* * * * *
      (2) [Reserved]
* * * * *
	(g) [Reserved]

13. Revise Appendix K to read as follows:
Appendix K To Subpart A Of Part 82 -- Commodity Codes From the Harmonized Tariff Schedule for Controlled Substances and Used Controlled Substances
                     Description of commodity or chemical
                Commodity code from harmonized tariff schedule
Class II:

HCFC-22 (Chlorodifluoromethane)
                                                                   2903.71.0000
HCFC-123 (Dichlorotrifluoroethane)
                                                                   2903.72.0020
HCFC-124 (Monochlorotetrafluoroethane)
                                                                   2903.79.1000
HCFC-141b (Dichlorofluoroethane)
                                                                   2903.73.0000
HCFC-142b (Chlorodifluoroethane)
                                                                   2903.74.0000
HCFC-225ca, HCFC-225cb (Dichloropentafluoropropanes)
                                                                   2903.75.0000
HCFC-21, HCFC-31, HCFC-133, and other HCFCs
                                                                   2903.79.9070
HCFC Mixtures (R-401A, R-402A, etc.)
                                                                   3824.74.0000
Class I:

CFC-11 (Trichlorofluoromethane)
                                                                   2903.77.0010
CFC-12 (Dichlorodifluoromethane)
                                                                   2903.77.0050
CFC-113 (Trichlorotrifluoroethane)
                                                                   2903.77.0020
CFC-114 (Dichlorotetrafluoroethane)
                                                                   2903.77.0030
CFC-115 (Monochloropentafluoroethane)
                                                                   2903.77.0040
    CFC-13, CFC-111, CFC-112, CFC-211, CFC-212, CFC-213, CFC-214, CFC-215, CFC-216, CFC-217, and other CFCs
                                                                   2903.77.0080
CFC Mixtures (R-500, R-502, etc.)
                                                                   3824.71.0100
Carbon Tetrachloride
                                                                   2903.14.0000
Halon 1301 (Bromotrifluoromethane)
                                                                   2903.76.0010
Halon, other
                                                                   2903.76.0050
Methyl Bromide
                                                                   2903.39.1520
Methyl Chloroform
                                                                   2903.19.6010

14. Amend section 82.62 by adding a definition for "polyurethane foam systems."
§82.62   Definitions.
* * * * *
Polyurethane Foam System means an item consisting of two transfer pumps that deliver ingredients (polyisocyanate or isocyanate from one side and a mixture including the blowing agent, catalysts, flame retardants, and/or stabilizers from the other side) to a metering/mixing device which allows the components to be delivered in the appropriate proportions.
* * * * *

15. Amend 82.66 by:
a. revising paragraphs (d)(vi) and (e), and
b. adding paragraph (f).
Revisions to read as follows:
§82.66 Nonessential Class I products and exceptions.
* * * * *
      (vi) Document preservation sprays which contain CFC-113 as a solvent, but which contain no other CFCs, and/or document preservation sprays which contain CFC-12 as a propellant, but which contain no other CFCs, and which are used solely on thick books, books with coated or dense paper and tightly bound documents;
      (e) Any air-conditioning or refrigeration appliance as defined in CAA 601(l) that contains a Class I substance used as a refrigerant; and
      (f) Any polyurethane foam system that contains any CFC.

16. Amend section 82.104 by revising paragraphs (c) and (h) to read as follows:
§82.104 Definitions.
* * * * *
      (c) Completely destroy means to cause the destruction of a controlled substance by one of the destruction processes approved by the Parties and listed in §82.3 of subpart A at a demonstrable destruction efficiency of 98 percent or more or a greater destruction efficiency if required under other applicable federal regulations.
      * * *
      (h) Destruction means the expiration of a controlled substance to the destruction efficiency actually achieved, unless considered completely destroyed as defined in this section. Such destruction might result in a commercially useful end product but such usefulness would be secondary to the act of destruction. Destruction must be achieved using one of the controlled processes approved by the Parties and listed in the definition of destruction in §82.3 of subpart A.
* * * * *

17. Amend section 82.106 by adding paragraph (a)(i) to read as follows:
* * * * *
      (i) Effective January 1, 2020, each container of fire suppression agent containing HCFC-123 produced or imported after that date shall bear the following warning statement, meeting the requirements of this subpart for placement and form;
      WARNING: Contains [insert name of substance], a substance which harms public health and environment by destroying ozone in the upper atmosphere. Do not use to service equipment manufactured on or after January 1, 2020.
* * * * *

18. Amend section 82.270 by revising paragraph (e) to read as follows:
§82.270 Prohibitions.
* * * * *
      (e) Effective April 6, 1998, no person shall dispose of halon except by sending it for recycling to a recycler operating in accordance with NFPA 10 and NFPA 12A standards, or by arranging for its destruction using one of the controlled processes approved by the Parties and listed in the definition of destruction in §82.3 of subpart A.
* * * * *