CALPUFF ANALYSIS IN SUPPORT OF THE JUNE 2005 CHANGES TO THE REGIONAL HAZE RULE June 15, 2005 1 The following is in support of the June 2005 revisions to the Regional Haze Rule ( RHR) and the Guidelines for Best Available Retrofit Technology ( BART) Determinations under the regional haze rule. The report documents a portion of the work involving the exercise of the CALPUFF dispersion model for assessing visibility impairment associated with proto typical BART eligible coal fired EGUs and industrial boilers. The procedures used to set up these analyses, the numerous intermediate steps, and the modeling results were shared and discussed with EPA staff involved in revising the regional haze rule over a period of eighteen months or more.

Background To reduce haze, and to meet the requirements of the Clean Air Act, EPA in April 1999 issued a regional haze rule aimed at protecting visibility in 156 federal areas. The rule seeks to reduce the visibility impairment caused by many sources over a wide area. EPA's previous visibility regulation, issued in 1980, addressed only local visibility impairment from local sources. Soon after the regional haze rule was finalized, several parties filed petitions challenging the rule with the U. S. Court of Appeals for the D. C. Circuit. Because regional haze is a problem caused by multiple sources over a wide area, EPA's rule required that states ( in determining BART requirements) assess visibility impairment on a cumulative basis using a regional air quality model;

i. e., as opposed to assessing visibility impairment on a source by source basis. In May 2002, the court ruled that EPA's approach to BART was not acceptable; specifically, the court maintained that the approach infringed on States' discretion by not providing an option for States to make BART determinations on an individual, source by source basis. Consequently, the court vacated portions of the regional haze rule related to BART and remanded to EPA for appropriate actions.

Use of CALPUFF for Regional Haze One of the first challenges encountered in responding to the court's remand involved the applicability of the CALPUFF dispersion model; currently, CALPUFF is the only dispersion model with capability for estimating secondarily formed particulates ( a critical ingredient in the 2 regional haze problem). The challenge we encountered is that CALPUFF, has not yet been fully tested for secondary formation and thus is not fully approved for regulatory applications such as PSD and NAAQS attainment demonstrations ( i. e., it is approved for primary particulates, but not for secondarily formed particulates). Our justification for using CALPUFF for BART is that,

unlike PSD and NAAQS, the BART modeling results do not, by themselves, determine the regulatory consequences. We believe that CALPUFF is based on sufficiently sound technical grounds to support assessments of relative impacts among BART eligible sources for the purposes of guiding more refined analyses and to help inform regulatory decisions that are based on a cumulative weight of evidence, such as the statutorily defined factors for consideration in assessing BART for regional haze.

The BART Process The BART process consists of the following:

1. Identify, in accordance with CAA Section 169A( b)( 2), whether a source is "

BARTeligible based on its source category, when it was put in service, and its emissions of one or more " visibility impairing" air pollutants including, gaseous precursors to visibilityimpairing particulate matter.

2. Determine whether a BART eligible source is " subject to BART" ( for any visibilityimpairing pollutant), based on an estimate of the source's impact on visibility.

3. Determine BART for the source by evaluating control options and selecting the " best"

alternative, taking into consideration:

! The costs of compliance,

! The energy and non air quality environmental impacts of compliance, 3 ! Any existing pollution control technology in use at the source,

! The remaining useful life of the source, and ! The degree of improvement in visibility that may reasonably be anticipated to result from the use of BART.

Our support to the BART process is focused on step 2, determining whether a BART eligible source is subject to BART based on an estimate of its' impact on visibility. Our approach to this task involved : ( 1) selection of sources to analyze, ( 2) creation of modeling domains to provide separate analyses for eastern and western locations, and ( 3) use of a range of emission rates to bracket analyses of most interest/ use to decision making for the BART rule. In the process of selecting sources for analyses we ended up constructing proto typical sources to represent two important categories in of the universe of BART eligible sources: coal fired boilers used to power electrical generating units ( EGUs) and coal fired industrial boilers. This process resulted in a total of 23 scenarios for analysis. Source characteristics and emission rates for the 23 scenarios are given in Table 1. The source characteristics are median values based on representative samples of BART eligible units. The emission rates were selected to address various questions related to the implementation of the BART requirement. It should be noted that although the emission rates are given in units of tons per year, there is no presumption that the values are actual or allowable. 4 Table 1 Emission rates and source parameters used in CALPUFF modeling for BART Eligible coal fired boilers Emission rates ( tpy) Run # Source ID Hgt Elev Diam Vel Temp SO2 NOx PM25 Domain ( m) ( m) ( m) ( m/ s) ( K)

1 EGU_ E# 1 100 200 8.0 27.0 400 10000 3500 50 Eastern 2 EGU_ W# 2 100 200 8.0 27.0 400 10000 6250 50 Western 3 EGU_ E# 3 100 200 8.0 27.0 400 5000 3500 50 Eastern 4 EGU_ W# 4 100 200 8.0 27.0 400 5000 6250 50 Western 5 EGU_ E# 5 100 200 8.0 27.0 400 1000 3500 50 Eastern 6 EGU_ W# 6 100 200 8.0 27.0 400 1000 6250 50 Western 7 EGU_ E# 7 100 200 8.0 27.0 400 1000 350 50 Eastern 8 EGU_ W# 8 100 200 8.0 27.0 400 1000 625 50 Western 9 EGU_ E# 9 100 200 8.0 27.0 400 30000 10000 50 Eastern 10 EGU_ E# 10 100 200 8.0 27.0 400 3000 10000 50 Eastern 11 EGU_ E# 11 100 200 8.0 27.0 400 3000 1000 50 Eastern 12 IB_ E# 12 55 200 2.6 11.4 414 7000 1400 20 Eastern 13 IB_ W# 13 55 200 2.6 11.4 414 7000 1400 20 Western 14 IB_ E# 14 55 200 2.6 11.4 414 900 1400 20 Eastern 15 IB_ W# 15 55 200 2.6 11.4 414 900 1400 20 Western 16 IB_ E# 16 55 200 2.6 11.4 414 900 300 20 Eastern 17 IB_ W# 17 55 200 2.6 11.4 414 900 300 20 Western 18 IB_ E# 18 55 200 2.6 11.4 414 0 1000 20 Eastern 19 IB_ E# 19 55 200 2.6 11.4 414 0 500 20 Eastern 20 IB_ W# 20 55 200 2.6 11.4 414 0 1000 20 Western 21 IB_ W# 21 55 200 2.6 11.4 414 0 500 20 Western 22 IB_ E# 22 55 200 3.1 11.4 478 7000 1400 20 Eastern 23 IB_ W# 23 55 200 3.1 11.4 478 7000 1400 20 Western Key to Source ID EGU Electrial Generating Unit IB Industrial Boiler _ E indicates the Eastern domain _ W indicates the Western domain # nn indicates the run number 1 Revision to the Guideline on Air Quality Models: Adoption of a Preferred Long Range Transport Model and Other Revisions; Final Rule, Federal Register/ Vol. 68, No. 72 / April 15, 2003 5 CALPUFF CALPUFF is an advanced meteorological and air quality modeling system recommended by the U. S. EPA as the preferred tool for evaluating impacts associated with the long range transport of primary pollutants. It was promulgated for regulatory use in specific circumstances in the Guideline on Air Quality Models, Appendix W to 40 CFR Part 511. CALPUFF is recommended by the Inter Agency Workgroup on Air Quality Models ( IWAQM) for use in evaluating impacts on visibility in the 156 Federal Class I areas. The modeling system consists of three main components: CALMET ( a diagnostic 3 dimensional meteorological model), CALPUFF ( an air quality dispersion model), and CALPOST ( a postprocessing package).

With few exceptions we have used the default CALPUFF settings as recommended in the IWAQM Phase II report. Our setups ( selections of model options and switch settings) for the three CALPUFF modules ( CALMET, CALPUFF, and CALPOST) are documented in the example command file input images provided in appendix A. Complete documentation on our use of CALPUFF for BART is included on a DVD which is being provided to the docket for the June 2005 changes to the regional haze rule. In the following we highlight portions of this material.

As mentioned previously, we created two modeling domains ( east and west) for use in evaluating the potential effects of our proto typical BART eligible sources The two domains are identical in terms of the overall size ( dimensions) and grid spacing. Each domain is a 600 x 600 km square sectioned into 75 x 75 horizontal grid cells and 10 vertical layers; the horizontal grid spacing is 8 km., vertical levels are located at 20,50,75, 100, 250, 500, 750, 1000, 2000, and 3000 m.

The location of the domain determines which meteorological stations will be used in CALMET to build the three dimensional wind fields used in CALPUFF. The Eastern domain is centered over 6 West Virginia and uses meteorological data for 5 upper air stations and 22 surface stations ( see Table A 2). The Western domain is centered over Denver and uses meteorological data for 3 upper air stations and 12 surface stations ( see Table A 1). Meteorological data for the five year period 1986 1990 were used for both domains.

The CALPUFF modeling domain is a subset of the CALMET domain. For both domains we employ a 5 grid cell ( 40 km) buffer to guard against edge effects at the boundaries; this results in a 520 km x 520 km CALPUFF domain. The proto typical source to be evaluated is placed at the center of the domain. Receptors for use in modeling were placed in concentric rings located every 25 km to a maximum range of 250 km; receptors were located every 10 degrees along each ring. Other than the meteorology there are no other domain specific factors in our CALPUFF modeling. Both domains were modeled in a flat terrain mode using a common source/ receptor base elevation of 200 m. In addition, there is no presumption regarding the location of Class I areas in our CALPUFF analyses. The unstated presumption, in the use of our results for BART,

is that all receptors are located in Class I areas.

Background Ozone  The IWAQM recommended default for ozone is 80 ppb. The results presented here are based on CALPUFF estimates using a background concentration of 50 ppb.

The lower value better characterizes the more recent data for the National Park Service monitoring sites.

Background Ammonia  The IWAQM recommended default for forested locations, 0.5 ppb, was used for the eastern domain. The IWAQM recommended value for arid locations, 1.0 ppb, was used for the western domain.

Metric for Tracking Progress Under the RHR According to the Regional Haze Rule, baseline visibility conditions, progress goals, and changes 7 ) 10 / ln( 10 ext b HI =

( )   dv b b ext m ext = + 10 1 0 ln _ _ in natural visibility conditions must be expressed in terms of deciview ( dv) units. The deciview is a unit of measurement of haze, implemented in a haze index ( HI) that is derived from calculated light extinction, and that is designed so that uniform changes in haziness correspond approximately to uniform incremental changes in perception, across the entire range of conditions,

from pristine to highly impaired. The HI is expressed by the following formula:

Here, a reference extinction coefficient of 10 ( Mm 1) in the denominator of the log corresponds to a ` pristine' environment and a haze index ( deciview) of zero. Because visibility impairment is a relative quantity, the estimated ( i. e., modeled) extinction for a particular source is not sufficient by itself to quantify the perceived effects on visibility of that source. This is because a given source impact ( extinction) that may go unnoticed when viewed against a hazy background may be acutely apparent when viewed against a pristine background. A fractional measure, made up of the modeled extinction coefficient ( b ext m) and a background extinction coefficient ( b ext 0), is needed to assess changes in visibility. Two such measures are computed and reported in CALPOST, the fractional ( percent) change in extinction and the change in the haze index (

deltadeciview

EPA tracks progress under the regional haze program using a metric for natural visibility conditions ( i. e., the goal of the regional haze program). This term is significant in and of itself to the extent that it has its own guidance document. The following is from EPA's guidance for estimating natural visibility conditions under the regional haze rule.

" The term natural visibility conditions represents the ultimate goal of the regional haze program, 8 consistent with the national visibility goal set forth in section 169A of the Clean Air Act ( CAA).

The national visibility goal is to remedy existing and prevent future human caused impairment of visibility in mandatory Federal Class I areas. Regional haze strategies are to make reasonable progress towards this goal.... estimates of natural visibility conditions should reflect contemporary conditions and land use patterns. That is, estimates should attempt to calculate the degree of visibility impairment that exists today, given current vegetative landscapes, when human emissions contributions are removed..... The 1991 peer reviewed report of the National Acid Precipitation Assessment Program( NAPAP) provides annual average estimates of natural concentrations for these six main components of PM for the eastern and western regions of the country. By applying assumptions for average extinction efficiencies for each PM component and for the effect of humidity, the NAPAP report also included estimates of natural visibility conditions on an annual average basis. With minor adjustments, these estimates provide the starting point for calculating natural visibility conditions in the mandatory Federal Class I areas The approach to estimating natural conditions presented in the NAPAP report defines two separate regions of the United States: ( 1) the East, which consists of all the States east of the Mississippi River, and up to one tier of States west of the Mississippi; and ( 2) the West , including the desert/ mountain regions of the Mountain and Pacific time zones. Geographically, these two subregions show strong differences in haze sources, vegetation, relative humidity, and regional haze levels. .... Table 2 1 presents the default estimated natural concentrations of the particulate species for the East and the West along with estimates of the dry extinction efficiencies for each species. These concentration estimates are used with the respective estimates of the dry extinction efficiencies to establish the light extinction attributed to natural sources in the East and West."

Natural Visibility Conditions Used with CALPUFF Domains With the information provided in EPA's guidance for estimating natural visibility, and with f( rh)

values specific to the East and West, ( also provided in the natural visibility guidance document)

we have the necessary information for calculating annual average natural visibility conditions for 9 the eastern and western CALPUFF modeling domains. The annual average natural extinction values for the eastern and western domains are 21.2 and 15.7 ( 1/ Mm), respectively; these values correspond to haze index values of 7 .5 and 4.5 deciviews, respectively.

RESULTS Visibility results for the 23 scenarios are given in Appendix B. For each scenario there is a table giving the number of days ( in the indicated year) that a given delta dv threshold ( 0.1, 0.5, and 1.0)

was exceeded at three distances ( 50, 100, and 200 km). A second table gives the ten highest delta dv values for each year ( 1986 1990) for the same three distances ( 50, 100, and 200 km). In the top ten tables, a 99th percentile is approximately equivalent to a value midway between the values for ranks 3 and 4. Similarly, a 98th percentile is approximately equivalent to the value associated with a rank of 7.

Caution to Readers Readers of this document are cautioned that it is not intended to provide guidance or recommendations on how to run CALPUFF for BART. By their very nature, illustrative modeling analyses using proto typical sources ( as described herein) necessitate a degree of creativity that would not generally be appropriate in a regulatory application. For example, a State will be modeling a real source and will know the direction and distance to the nearest Class I area; one would not expect a State to treat the entire modeling domain as a Class I area as was done in the illustrative analyses described here. Although our procedures included the use of default model options and switch settings, one should not view this as either precluding other procedures or providing guarantees that using these procedures will result in actions that are fully approvable.


Boilers -- Major Source and Area sources - Deadlines Jim Eddinger

                                                Thursday, June 07, 2012 01:58PM

From:

To: Higgins, Cortney                                                                                Cc: RobertJ Wayland, Peter Tsirigotis, Susmita Dubey, Jonathan Averback, Mary Johnson

Cortney,

As you requested in you call today, attached is a one-pager listing the various deadlines of the March 2011 final boiler rules, along with the NAA dates and actions.

(See attached file: Deadlines for Boiler.docx)

Jim _______________ James A. Eddinger Energy Strategies Group Sector Policies and Programs Division 919-541-5426

Deadlines for Boiler.docx


[Federal Register Volume 85, Number 111 (Tuesday, June 9, 2020)]
[Notices]
[Pages 35305-35306]
[FR Doc No: 2020-12473]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-116-000]

Texas Gas Transmission, LLC; Notice of Request for Extension of
Time

    Take notice that on May 26, 2020, Texas Gas Transmission, LLC
(Texas Gas) requested that the Federal Energy Regulatory Commission
(Commission) grant an extension of time, until June 26, 2021, to
abandon the North Lake Pagie/Bay Junop-Bay Round Project (Project)
located in Terrebonne Parish, Louisiana authorized on June 26, 2018.
    Texas Gas was initially required to abandon the Project by June 26,
2019. On June 10, 2019, the Commission extended this deadline through
June 26, 2020 to accommodate ongoing landowner negotiations and to
obtain the necessary environmental permits for the Project, per Texas
Gas's request. Texas Gas now requests for an additional year to
complete abandonment activities by June 26, 2021. Texas Gas states that
landowner negotiations are ongoing and that it continues to work on
obtaining a Coastal Use Permit prior to commencing the Project.
Accordingly, Texas Gas believes landowner negotiations and the
obtainment of a Coastal Use Permit are imminent.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on Texas Gas request for
an extension of time may do so. No reply comments or answers will be
considered. If you wish to obtain legal status by becoming a party to
the proceedings for this request, you should, on or before the comment
date stated below, file a motion to intervene in accordance with the
requirements of the Commission's Rules of Practice and Procedure (18
CFR 385.214 or 385.211) and the Regulations under the Natural Gas Act
(18 CFR 157.10).\1\
---------------------------------------------------------------------------

    \1\ Only motions to intervene from entities that were party to
the underlying proceeding will be accepted. Algonquin Gas
Transmission, LLC, 170 FERC ] 61,144, at P 39 (2020).
---------------------------------------------------------------------------

    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\2\ the
Commission will aim to

issue an order acting on the request within 45 days.\3\ The Commission
will address all arguments relating to whether the applicant has
demonstrated there is good cause to grant the extension.\4\ The
Commission will not consider arguments that re-litigate the issuance of
the certificate order, including whether the Commission properly found
the project to be in the public convenience and necessity and whether
the Commission's environmental analysis for the certificate complied
with the National Environmental Policy Act.\5\ At the time a pipeline
requests an extension of time, orders on certificates of public
convenience and necessity are final and the Commission will not re-
litigate their issuance.\6\ The OEP Director, or his or her designee,
will act on all of those extension requests that are uncontested.
---------------------------------------------------------------------------

    \2\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2019).
    \3\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \4\ Id. at P 40.
    \5\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \6\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and three copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on June 16, 2020.

    Dated: June 1, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-12473 Filed 6-8-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Notices]
[Page 76800]
[DOCID:fr28de05-90]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. OR06-2-000; IS06-70-000; IS06-63-000; IS06-71-000; IS06-
66-000; IS06-47-000]

Anadarko Petroleum Corporation, Tesoro Corporation, and Tesoro
Alaska Company v. TAPS Carriers, BP Pipelines (Alaska) Inc.,
ConocoPhillips, Transportation Alaska, Inc., ExxonMobil Pipeline
Company, Koch Alaska Pipeline Company LLC, Unocal Pipeline Company;
Notice of Complaint

December 19, 2005.
    Take notice that on December 14, 2005, Anadarko Petroleum
Corporation, Tesoro Corporation, and Tesoro Alaska Company
(collectively, Anadarko/Tesoro) filed a protest, complaint, motion to
intervene, motion to consolidate, and request for hearing and other
relief, against BP Pipelines (Alaska) Inc., ConocoPhillips
Transportation Alaska, Inc., ExxonMobil Pipeline Company, Koch Alaska
Pipeline Company LLC, and Unocal Pipeline Company (collectively, TAPS
Carriers), pursuant to Rules 206, 211, 212, and 214 of the Commission's
Rules of Practice and Procedures and sections 8, 9, 13, 15, and 16 of
the Interstate Commerce Act , and the Commission's oil pipeline
regulations at 18 CFR 343. Anadarko/Tesoro allege that the rates filed
by TAPS Carriers for oil transportation on the TAPS are unjust,
unreasonable, and unduly discriminatory under the ICA, and the
Commission should suspend those rates, declare those rates subject to
refund, initiate hearing procedures, establish just and reasonable
rates as required by the ICA, and grant Anadarko/Tesoro refunds,
reparations, damages (with interest), and other appropriate relief.
Anadarko/Tesoro request that the Commission consolidate this protest
and complaint with the ongoing proceedings concerning the TAPS
Carriers' rates in Docket Nos. IS05-82 et al.
    Anadaro/Tesoro states that copies of the complaint were served on
the designated contacts for BP Pipelines (Alaska), Inc. ConocoPhillips
Transportation Alaska, Inc., ExxonMobile Pipeline Compnay, Koch Alaska
Pipeline Company LLC., and Unocal Pipeline Company as listed in the
individual company tariff filings, as well as on all persons on the
official Commission service list.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on January 3, 2006.

 Magalie R. Salas,
Secretary.
 [FR Doc. E5-7920 Filed 12-27-05; 8:45 am]

BILLING CODE 6717-01-P


<COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE  (7/1/2006)>

<EPA Registration Division contact: Shaja R. Brothers,<PHONE_NUMBER>>

INSTRUCTIONS:

<Interregional Research Project Number 4 (IR-4) >

<PP 7E7300>

<	EPA has received a pesticide petition (PP) 7E7300 from Interregional
Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W,
Princeton, NJ 05840 proposing, pursuant to section 408(d) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR
part 180. <by establishing tolerances for residues of propiconazole,
1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]
methyl]-1H-1,2,4-triazole and its metabolites determined as
2,4,-dichlorobenzoic acid and expressed as parent compound in or on the
following commodities:  beet, garden, roots at 0.6 parts per million
(ppm); parsley, leaves at 13 ppm, parsley, dried leaves at 60 ppm,
coriander, fresh at 13 ppm, vegetable, leaves of root and tuber, group
at 8.0 ppm, pineapple (post harvest) at 0.9 ppm, and turnip, roots at
0.2 ppm.  EPA has determined that the petition contains data or
information regarding the elements set forth in section 408 (d)(2) of
the FDDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
petition. Additional data may be needed before EPA rules on the
petition.>

>

<A. Residue Chemistry>

<1. Plant metabolism. The metabolism of propiconazole as well as the
nature of the residues is adequately understood for purposes of the
tolerances.  Plant metabolism has been evaluated in five diverse crops,
wheat, grapes, celery, peanuts and carrots which should serve to define
the similar metabolism of propiconazole in a wide range of crops.  The
plant metabolism pathway for propiconazole is well understood.  Parent
metabolite CGA-64250 is the major compound found in crops.  Comparison
of the metabolism of propiconazole in different plant species shows that
the differences between the respective metabolic pathways to be
quantitative in nature. >

<	2. Analytical method. The metabolism data in plants and animals
suggest that analytical methods to detect either the phenyl or the
triazole ring would be appropriate for the measurement of residues.
However, because of the natural occurrence of compounds that interfere
with the measurement of triazoles, methods designed to detect this
moiety have been proven unreliable and unacceptable.  Conversely,
conversion of phenyl moiety to 2,4-dichlorobenzoic acid (DCBA) has
proven to be satisfactory for all agricultural products analyzed to
date.  Analytical methods AG-626 and AG-454A were developed for the
determination of residues of propiconazole and its metabolites
containing the DCBA moiety.   Analytical method AG-626 has been accepted
and published by EPA as the tolerance enforcement method for crops.  The
limit of quantitation (LOQ) for the method is 0.05 ppm.

	3. Magnitude of residues. The limit of quantitation of (LOQ) for the
method in all matrices were 0.05 ppm.>

<

	i.  Garden beet.  Five beet trials (5) were conducted in Oregon, New
York, Wisconsin, Michigan, and Texas, representing NAFTA growing regions
1, 5, 6, and 12.  The number of trials and geographic representation are
adequate for garden beet.   In each trial, four applications of Tilt 3.6
EC at a rate of approximately 0.169 lb ai/A each were made, for a total
of approximately 0.676 lb ai/A.  Applications were made 10 to 15 days
apart and timed so that mature beets could be collected 14 to 16 days
after the final application.  Samples were analyzed using a procedure
adapted from the Novartis Crop Protection, Inc., method AG-626,
“Determination of Total Residues of Propiconazole in Crops as 2,
4-Dichlorobenzoic Acid Methyl Ester by Capillary Gas Chromatography”.
Modifications were made to improve the performance of the method.
Maximum propiconazole residues were 4.3 ppm in tops samples.  Residues
were significantly lower in root samples, with a maximum residue of 0.27
ppm.

	ii. Turnip.   HYPERLINK  \l "_Appendix_1_FIELD" Six field trials  were
conducted for this study during the 1997 to 1998 growing season, one
each in New Jersey (  HYPERLINK  \l "_Table_B.1.3:__Trial numbers and
geo"  EPA Region 2 ), Tennessee (Region 2), Georgia (Region 2), Texas
(Region 6), Ohio (Region 5), and California (Region 10).  The number
of field trials is in accordance with OPPTS Guideline 860.1500.  In each
trial, at least four foliar applications of Tilt 3.6EC at a rate of
approximately 0.169 lb ai/A each were applied, for a total of
approximately 0.676 lb ai/A.  The applications were made 9 to 16 days
apart, and timed so that mature turnip tops and roots could be collected
approximately 14days following the last application.   HYPERLINK  \l
"_Appendix_2_Analytical_Summary Repor" Samples were analyzed  for
residues of propiconazole and its metabolites contaning the DCBA moiety
using Novartis method AG-626.  Modifications were made to improve the
performance of the method.  Maximum residues in turnip tops were 4.29
ppm.  No residues were observed in root samples above the lowest level
of method validation (0.2 ppm).  >

	iii. Parsley.  Four residue field trials were conducted in Texas,
California, and New Jersey.  A total of approximately 0.45 lb ai/A was
applied to the treated plots in four foliar applications of Tilt 3.6EC
at a rate of approximately 0.1125 lb ai/A each.  Mature fresh and dried
parsley was collected approximately 14 days after the final application.

 HYPERLINK  \l "_Appendix_2_Analytical_Summary Repor" Samples were
analyzed  for residues of propiconazole and its metabolites containing
the DCBA moiety using Novartis method AG-626.  Maximum propiconazole
residues were 6.5 ppm in fresh samples.  Residues were concentrated in
dried samples, with a maximum residue of 21 ppm

	iv. Pineapple (post- harvest).  Three residue field trials were
conducted in Hawaii (EPA Region 13). The geographic representation of
field trials is in accordance with OPPTS Guideline 860.1500.  Pineapples
were dipped in a solution of Tilt 3.6EC at approximately 0.125 lb ai/100
gal water.   Three different post-harvest treatments with Tilt 3.6E were
examined. The treatment solutions contained either: 1) no adjuvant, 2)
fruit wax at approximately 1 gal/8 gal water, or 3) fruit oil at
approximately 10 gal/100 gal water.  Following treatment, the
pineapples were allowed to dry and the crowns were removed.  Samples of
the fruit treated with Tilt 3.6E and wax were processed into edible
fresh pulp, peel, beverage juice, and process residue samples.

The method for sample analysis was derived from both the Ciba-Geigy
Corporation method AG-454B, “Determination of Total Residues of
Propiconazole in Crops as 2,4-Dichlorobenzoic Acid by Capillary Gas
Chromatography” and the Novartis Crop Protection, Inc., method AG-626,
“Determination of Total Residues of Propiconazole in Crops as
2,4-Dichlorobenzoic Acid Methyl Ester by Capillary Gas
Chromatography.”   Modifications were made to improve the performance
of the method.

The maximum residue observed in pineapple fruit samples dipped in Tilt
3.6E alone was 4.1 ppm.  Addition of wax and oil decreased the residues
by more than 75% to a maximum residue of 0.82 ppm.  Residues in peel
samples were 0.35 ppm, while residues detected in process residue
samples were slightly higher at 0.67 ppm.  Residues in edible fresh
pulp and beverage juice samples were less than the lowest level of
method validation of 0.05 ppm.

<B. Toxicological Profile>

<1. Acute toxicity.  Propiconazole exhibits low toxicity.  Data
indicated the following:  a rat acute oral LD50 of 1,517
milligrams/kilograms (mg/kg); a rabbit acute dermal LD50 >6,000 mg/kg; a
rat inhalation LC50 >5.8 mg/liter air; minimal skin and slight eye
irritation; and nonsensitization>.

<2. Genotoxicty. Propiconazole exhibits low toxicity.  Data indicated
the following:  a rat acute oral LD50 of 1,517 milligrams/kilograms
(mg/kg); a rabbit acute dermal LD50 >6,000 mg/kg; a rat inhalation LC50
>5.8 mg/liter air; minimal skin and slight eye irritation; and
nonsensitization.>

<3. Reproductive and developmental toxicity.  In an oral teratology
study in the rabbit, a maternal no observed adverse effect level (NOAEL)
of 30 mg/kg was based on reduced food intake but without any
fetotoxicity even at the top dose of 180 mg/kg.  In an oral teratology
study in the rabbit, a maternal NOAEL of 100 mg/kg was based on
reductions in body weight gain and food consumption and a fetal NOAEL of
250 mg/kg was based on increased skeletal variations at 400 mg/kg.  In
an oral teratology study in the rat, a maternal and fetal NOAEL of 100
mg/kg was based on decreased survival, body weight gain, and food
consumption in the dams and delayed ossification in the fetuses at 300
mg/kg.  In a second teratology study in the rat, a maternal and fetal
NOAEL of 30 mg/kg was based on reductions in body weight gain and food
consumption in the dams and delayed development in the fetuses at 90 and
360/300 mg/kg.  A supplemental teratology study in the rat involving
eight times as many animals per group as usually required showed no
teratogenic potential for the compound.  A 2-generation reproduction
study in the rat showed excessive toxicity at 5,000 ppm without any
teratogenic effects.  A 2-generation reproduction study in the rat
showed no effects on reproductive or fetal parameters at any dose level.
 Postnatal growth and survival were affected at the top dose of 2,500
ppm, and parental toxicity was also evident.  The NOAEL for development
toxicity is 500 ppm.>

<4. Subchronic toxicity.  In a 21-day dermal study in the rabbit, a
NOAEL of 200 mg/kg was based on clinical signs of systemic toxicity.  In
a 28-day oral toxicity study in the rat, a NOAEL of 50 mg/kg was based
on increased liver weight. In a subchronic feeding study in the mouse, a
NOAEL of 20 ppm (3 mg/kg) was based on liver pathologic changes. In a 13
week feeding study in the male mouse, a NOAEL of 20 ppm (3 mg/kg) was
based on liver pathologic changes.  In a 90 day feeding study in rats,
the NOAEL was 240 ppm (24 mg/kg) based on a reduction in body weight
gain. In a 90 day feeding study in dogs, the NOAEL was 250 ppm (6.25
mg/kg) based on reduced food intake and stomach histologic changes.>

<5. Chronic toxicity.  In a 12-month feeding study in the dog, a NOAEL
of 50 ppm (1.25 mg/kg) was based on stomach histologic changes.  In a 24
month oncogenicity feeding study in the mouse, the NOAEL was 100 ppm (15
mg/kg).  The MTD was exceeded at 2,500 ppm in males based on decreased
survival and body weight. Increased incidence of liver tumor was seen in
these males but no evidence of carcinogenicity was seen at the next
lower dose of 500 ppm in either sex.  In a 24 month chronic
feeding/oncogenicity study in the rat, a NOAEL of 100 ppm (5 mg/kg) was
based on body weight and blood chemistry.  The MTD was 2,500 ppm based
on reduction in body weight gain and no evidence of oncogenicity was
seen.  Based on the available chronic toxicity data, Syngenta believes
the Reference dose (RfD) for propiconazole is 0.0125 mg/kg/day.  This
RfD is based on a 1 year feeding study in dogs with a NOAEL of 1.25
mg/kg/day (50 ppm) and an uncertainly factor of 100.  No additional
modifying factor for the nature of effects was judged to be necessary as
stomach mucous hyperemia was the most sensitive indicator of toxicity in
that study.

Using the Guidelines for Carcinogenic Risk Assessment published on
September 24, 1986 (51 FR 33992), the USEPA has classified propiconazole
in group C for carcinogenicity (evidence of possible carcinogenicity for
humans).  The compound was tested in 24 month studies with both rats and
mice.  The only evidence of carcinogenicity was an increase in liver
tumor incidence in male mice at a dose level that exceeded the maximum
tolerated dose (MTD).  Dosage levels in the rat study were appropriate
for identifying a cancer risk.  The Cancer Peer Review Committee
recommended the RfD approach for quantitation of human risk.  Therefore,
the RfD is deemed protective of all chronic human health effects,
including cancer.  >

<	6. Animal metabolism. Metabolism in animals is similar to plant
metabolism. In animals both the rat and the goat rapidly metabolize and
excrete propiconazole.  Neither animal retains significant amounts of
propiconazole or its metabolites in tissues.  Significant quantities of
parent or metabolites do not appear in goat’s milk.  Similar
metabolites are produced by both species, and unconjugated (phase I)
metabolites are similar in plants and animals.  The metabolism profile
supports the use of an analytical enforcement method that accounts for
combined residues of propiconazole and its metabolites that contain the
2,4-dichlorobenzoic acid (DCBA) moiety.

>

<7. Metabolite toxicology.  There are no metabolites of concerned based
on a differential metabolism between plants and animals.>

<8. Endocrine disruption. Developmental toxicity studies in rats and
rabbits and reproduction studies in rats gave no indication that
propiconazole might have any effects on endocrine function related to
development and reproduction.  The subchronic and chronic studies also
showed no evidence of a long–term effect related to the endocrine
system.  Further, due to the moderate rate of degradation of the
product, there is no risk that propiconazole may accumulate in the
environment.  In animals, propiconazole is quickly excreted and has no
tendency for accumulation in the body.  Based on these results, it is
very likely that propiconazole has no potential to interfere
specifically with the endocrine system.>

<C. Aggregate Exposure>

<	1. Dietary exposure. Tier I acute and chronic dietary exposure
evaluations were completed for propiconazole using the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCIDTM, version 2.14) from Exponent.  Propiconazole is currently
registered on the following crops: alfalfa (inadvertent), bananas,
barley, sugar beets, berries (Crop Group 13), carrots, corn (field,
sweet and popcorn), cranberries (Section 24c), stone fruits (Crop Group
12), grasses, leaf petioles (Crop Subgroup 4B), mushrooms, tree nuts
(Crop Group 14), oats, onions (bulb and green), peanuts, peppermint,
pineapples (seed piece treatment), pistachios, rice, rye, sorghum,
soybeans, spearmint, strawberries, wheat and wild rice (Section 24c).
Propiconazole is proposed for use in or on garden beets, parsley,
pineapples (post-harvest treatment), turnips and leaves of root and
tuber vegetables (Crop Group 2).  These exposure assessments include all
current and proposed propiconazole tolerances.  Percent of crop treated
values were conservatively estimated to be 100% for all uses and default
processing factors from DEEM™ (version 7.87) were used for processed
commodities.>

Food.   Acute Risk.  The acute dietary (food only) risk assessment was
performed for all population subgroups with an acute reference dose of
0.3 mg/kg-bw/day based on an acute no observable adverse effect level
(NOAEL) of 30 mg/kg-bw/day from an acute neurotoxicity study in rats and
an uncertainly factor of 100X.  The 100X safety factor included intra-
and inter-species variations.  No additional FQPA safety factor was
applied.  For the purpose of the aggregate risk assessment, the exposure
value was expressed in terms of margin of exposure (MOE), which was
calculated by dividing the NOAEL by the exposure for each population
subgroup.  In addition, exposure was expressed as a percent of the acute
reference dose (%aRfD).  Acute exposure to the U.S. population resulted
in a MOE of 1,699 (5.9% of the acute RfD of 0.3 mg/kg-bw/day).  Acute
exposure to the most sensitive subpopulation (children 1-2 years old)
resulted in a MOE of 826 (12.1% of the acute RfD of 0.3 mg/kg-bw/day).
Since the benchmark MOE for this assessment is 100 and since EPA
generally has no concern for exposures below 100% of the RfD, Syngenta
believes that there is a reasonable certainty that no harm will result
from acute dietary (food) exposure to residues arising from the current
and proposed uses for propiconazole.

Chronic Risk.  The chronic dietary (food only) risk assessment was
performed for all population subgroups with a chronic reference dose of
0.1 mg/kg-bw/day based on a 24-month oncogenicity study in mice with a
NOAEL of 10 mg/kg-bw/day and an uncertainly factor of 100X.  The 100X
safety factor included intra- and interspecies variations.  No
additional FQPA safety factor was applied.  For the purpose of the
aggregate risk assessment, the exposure values were expressed in terms
of margin of exposure (MOE), which was calculated by dividing the NOAEL
by the exposure for each population subgroup.  In addition, exposure was
expressed as a percent of the reference dose (%RfD).  Chronic exposure
to the U.S. population resulted in a MOE of 1,771 (5.6% of the chronic
RfD of 0.1 mg/kg-bw/day).  Chronic exposure to the most exposed
sub-population (children 1-2 years old) resulted in a MOE of 710 (14.1%
of the chronic RfD of 0.1 mg/kg-bw/day).  Since the benchmark MOE for
this assessment is 100 and since EPA generally has no concern for
exposures below 100% of the RfD, Syngenta believes that there is a
reasonable certainty that no harm will result from chronic dietary (food
only) exposure to residues arising from all current, pending and
proposed uses for propiconazole.

Cancer Risk.  A quantitative risk assessment using a cancer endpoint was
not performed.  The chronic risk assessment is adequately protective for
cancer risk as well as other chronic effects.

nd chronic) were used in the DEEM-FCID™ analysis to estimate the
dietary exposure from drinking water.

Acute Exposure from Drinking Water.  The acute drinking water estimate
from turf uses (55.8 ppb) was incorporated directly into the dietary
exposure assessment along with the food exposure.  Acute dietary (food
and water) exposure to the U.S. population resulted in a MOE of 1,552
(6.4% of the acute RfD of 0.3 mg/kg/day).  The most exposed
sub-population was all infants (<1 year old) with a MOE of 765 (13.1% of
the acute RfD).  Based on these results, there is no concern for acute
risk from either surface or ground water from all current, pending and
proposed uses of propiconazole.

Chronic Exposure from Drinking Water.  The chronic drinking water
estimate from turf uses (21.6 ppb) was incorporated directly into the
dietary exposure assessment along with the food exposure.  Chronic
dietary (food and water) exposure to the U.S. population resulted in a
MOE of 1,639 (6.1% of the chronic RfD of 0.1 mg/kg/day).  The most
exposed sub-population was children (1-2 years old) with a MOE of 678
(14.8% of the chronic RfD).  Based on these results, there is no concern
for chronic risk from either surface or ground water from all current,
pending and proposed uses of propiconazole.

>

<	2. Non-dietary exposure. Short-term and intermediate-term risk
exposure assessments were conducted for non-dietary uses of
propiconazole since it is currently registered for residential use on
turf and for antimicrobial uses (paint and lumber).  Adult turf use
scenarios included dermal exposure for residential handlers (short-term
only) and dermal exposure from post-application scenarios (short-term
only).  For children, short-term risk assessment scenarios were run for
turf use and antimicrobial uses on lumber.  Intermediate-term risk
assessments were also run for children playing on propiconazole-treated
structures such as decks and/or play sets.  The short-term and
intermediate-term scenarios for children included both dermal exposure
and incidental oral exposure via hand to mouth and object to mouth.  The
short-term oral and dermal endpoint was 30 mg/kg/day.  The
intermediate-term oral and dermal endpoint was 10 mg/kg/day.  The
worst-case adult turf use scenario (post-application, general high
contact activities) provided a short-term MOE of 350 which is above the
EPA’s level of concern.  For post-application exposures to treated
lawns, the worst-case combined short-term MOE for children was 170 based
on dermal and non-dietary oral exposure.  For dermal and incidental oral
exposure of children playing on propiconazole-treated structures, the
combined intermediate-term MOE for children was 140.  Since the EPA’s
benchmark MOE for propiconazole is 100, the residential exposure for
both adults and children do not exceed EPA’s level of concern.

>

<D. Cumulative Effects>

<	Cumulative Exposure to Substances With a Common Mechanism of Toxicity.
 Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity”.  Propiconazole is a member of the
triazole-containing class of pesticides.  Although conazoles act
similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there
is not necessarily a relationship between this pesticidal activity and
their mechanism of toxicity in mammals.  Structural similarities do not
constitute a common mechanism of toxicity.  There is currently no
evidence to indicate that conazoles share common mechanisms of toxicity
and the EPA is not following a cumulative risk approach based on a
common mechanism of toxicity for the conazoles.>

<E. Safety Determination>

<	1. U.S. population. Using the conservative assumptions described
above, and based on the completeness and reliability of the toxicity
data, the acute aggregate (food plus water) exposure calculation for all
current, pending and proposed uses of propiconazole provided a MOE of
1,552 for the U.S. population.  The chronic aggregate exposure analysis
(food and water) showed that exposure from all current and proposed
propiconazole uses resulted in a MOE of 1,639 for the U.S. population.
For short-term exposures, the chronic dietary (food and water) exposure
was aggregated with the residential exposure resulting in a short-term
aggregate MOE of 327 for the U.S. population.  An intermediate-term
aggregate exposure analysis (food, water and residential) was not
required for adults for residential uses of propiconazole.  Since the
worst case aggregate MOE of 327 (short-term risk) exceeds the benchmark
MOE of 100, Syngenta believes that there is a reasonable certainty that
no harm will occur to the U.S. Population from aggregate exposures
arising from all current and proposed uses for propiconazole.>

<	2. Infants and children. Using the conservative assumptions described
in the exposure section above, and based on the completeness and
reliability of the toxicity data, the acute aggregate (food plus water)
exposure calculation for all current, pending and proposed uses of
propiconazole provided a MOE of 765 for all infants <1 year old (the
most sensitive population subgroup).  The chronic aggregate exposure
analysis (food and water) showed that exposure from all current, pending
and proposed propiconazole uses resulted in a MOE of 678 for the most
sensitive population subgroup (children 1-2 years old).  A short-term
aggregate exposure analysis (food, water and residential) was determined
for small children since they represent the worst-case scenario with
both dietary (food and water) exposure and two routes of non-dietary
exposure (dermal and incidental oral) from turf residues.  For
short-term exposures, the chronic dietary (food and water) exposure was
aggregated with the residential exposure resulting in a short-term
aggregate MOE of 157 for children 1-2 years old.  An intermediate-term
aggregate exposure analysis (food, water and residential) was determined
to account for potential residues from decks and/or playsets made with
lumber treated with propiconazole (antimicrobial use).  For
intermediate-term exposures, the chronic dietary (food and water)
exposure was aggregated with the residential exposure resulting in a
short-term aggregate MOE of 116 for children 1-2 years old  Since the
worst case aggregate MOE of 116 (intermediate-term risk) exceeds the
benchmark MOE of 100, Syngenta believes that there is a reasonable
certainty that no harm will occur to infants and children from aggregate
exposure to residues arising from all current and proposed uses of
propiconazole, including anticipated dietary exposure from food, water
and all other types of non-occupational exposures.>

<F. International Tolerances>

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᐀expression includes all metabolites determined as
2,4-dichloro-benzoic acid.  In conjunction with the reregistration
process EPA intends to revise the tolerance expression to propiconazole
per se.  To the extent possible, for the present petitions, U.S.
tolerances have been numerically harmonized with Codex, Canadian and
Mexican MRLs; however, differences in use patterns and the supporting
residue data have precluded reducing many tolerances.  A summary of
Codex MRLs, Canadian MRLs and Mexican tolerances and the corresponding
U.S. tolerances for propiconazole is discusses at   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov  Docket No.
EPA-HQ-OPP-2006-0347-0004; pages 53-54.>


Meeting Summary

EPA/Arch Chemical/Dow Chemical/Steptoe & Johnson

October 6, 2010, 2:00 PM to 3:00 PM

Room S-7100, 2777 S. Crystal Drive, Arlington, VA 22202

Participants

Dow Chemical, Arch Chemical and Steptoe & Johnson Registrants: Joanne
Ryder, Nick Skoulis, George Hazleton, Gary Schifilliti, Elizabeth Brown,
Judy Hauswirth, Seth Goldberg

EPA: Stephen Dapson, A. Najm Shamim, Steven Malish, PV Shah, Yintak Woo,
Jonathan Chen, Nader Elkassabany, Tim McMahon, Mark Hartman, Lance
Wormell, Mary Manibusan, Rebecca von dem Hagen

Summary

On Wednesday, October 6, 2010, AD hosted a meeting with
1,2-Benzisoththiazolin-3-one (BIT) registrants Arch Chemical and Dow
Chemical.  The registrants requested this meeting to discuss the
Agency’s preliminary response to waiver requests for the chronic
toxicity and carcinogenicity studies required through the March 2008
post-RED DCI.  During the meeting, the registrants presented an overview
of BIT, information on isothiazolinone biocides and presented their
argument that the required BIT data should be bridged from existing data
on other isothiazolinone biocides (OIT, DCOIT, CMIT/MIT, and MIT).  The
registrants also questioned the need for additional studies noted in the
July 2010 memo.

Next Steps

The Agency requested more information on (1) the impact of radioactivity
in the repeated dose metabolic study on the thyroid and (2) the
radiolabeling of the Benzene ring in metabolism studies.  The receipt of
this additional information will enable the Agency to make a decision on
the waiver requests.

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