[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74669-74670]
[FR Doc No: 2012-30308]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Draft and Revised Draft Guidances for Industry Describing
Product-Specific Bioequivalence Recommendations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
June 11, 2010, FDA announced the availability of a guidance for
industry entitled ``Bioequivalence Recommendations for Specific
Products,'' which explained the process that would be used to make
product-specific BE recommendations available to the public on FDA's
Web site. The BE recommendations identified in this notice were
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
these draft and revised draft guidances before it begins work on the
final versions of the guidances, submit either electronic or written
comments on the draft and revised draft product-specific BE
recommendations listed in this notice by February 15, 2013.

ADDRESSES: Submit written requests for single copies of the individual
BE guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, 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access to the draft guidance recommendations.
    Submit electronic comments on the draft product-specific BE
recommendations to http://www.regulations.gov. Submit written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kris Andr[eacute], Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as
a means to develop and disseminate product-specific BE recommendations
and provide a meaningful opportunity for the public to consider and
comment on those recommendations. Under that process, draft
recommendations are posted on FDA's Web site and announced periodically
in the Federal Register. The public is encouraged to submit comments on
those recommendations within 60 days of their announcement in the
Federal Register. FDA considers any comments received and either
publishes final recommendations or publishes revised draft
recommendations for comment. Recommendations were last announced in the
Federal Register of September 14, 2012 (77 FR 56851). This notice
announces draft product-specific recommendations, either new or
revised, that are being posted on FDA's Web site concurrently with
publication of this notice.

II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing new draft product-specific BE recommendations for
drug products containing the following active ingredients:

A
    Abiraterone acetate
    Albendazole
    Amlodipine besylate, hydrochlorothiazide, and olmesartan
medoxomil
C
    Clindamycin phosphate; tretinoin
    Clorazepate dipotassium
F
    Ferumoxytol
G
    Gabapentin
P
    Piroxicam
S
    Sodium Phosphate, dibasic, anhydrous; sodium phosphate,
monobasic, monohydrate

U
    Ulipristal acetate
W
    Warfarin sodium

III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing revised draft product-specific BE recommendations
for drug products containing the following active ingredients:

D
    Desmopressin acetate
    Diflunisal
    Dipyridamole
H
    Hydrochlorothiazide; lisinopril
    Hydrochlorothiazide; losartan potassium
L
    Liothyronine sodium
P
    Phenoxybenzamine hydrochloride
Q
    Quinine sulfate
R
    Risedronate sodium
T
    Tacrolimus
    Thalidomide
    Tinidazole

    For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, please go to
http://www.regulations.gov and enter docket number FDA-2007-D-0369.
    These draft and revised draft guidances are being issued consistent
with FDA's good guidance practices regulation (21 CFR 10.115). These
guidances represent the Agency's current thinking on product-specific
design of BE studies to support ANDAs. They do not create or confer any
rights for or on any person and do not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments on any of the
specific BE recommendations posted on FDA's Web site to http://www.regulations.gov. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. The guidances, notices, and received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30308 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: May 31, 2007 (Volume 72, Number 104)]
[Notices]
[Page 30362]
[DOCID:fr31my07-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-384-000]

Georgia-Pacific LLC (Formerly Georgia-Pacific Corporation);
Notice of Application

May 23, 2007.
    Take notice that on May 18, 2007, pursuant to section 7(b) of the
Natural Gas Act (NGA) and 18 C.F.R. Part 157 of the regulations of the
Commission, Georgia-Pacific LLC (GP) filed with the Commission an
Abbreviated Application of Georgia-Pacific LLC To Amend Its Part 157
Certificate.
    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. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    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 June 7, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-10429 Filed 5-30-07; 8:45 am]

BILLING CODE 6717-01-P


Date Modified: By: Data Sources: Description:

The original version of be used to reveal CBI. been replaced with dum have been added to illu facility. Any observed values. It should also 5/ 25/ 2006 Abt Associates Inc. IPM_ BoilerLevelDataToABT. xls Generates steam plant type and steam capacity for Phase III facilities modeled by the IPM of this file contains, or is linked to a file that contains, confidential business information ( CBI), or information th BI. As a result, the values for any variables determined by EPA to be CBI, or that could be used to reveal CBI, ummy values. Such variables have been marked with light orange highlight. It should be noted that the dumm illustrate how the spreadsheets work; they may not always be consistent with other data provided for the same ed patterns of the dummy values is for illustration purposes only and has no significance with respect to the orig o be noted that any information that uses the dummy values will not show the true results of EPA's analysis. that could BI, have mmy values e model original Sum of Capacity MW PlantType Plant ID Biomass Coal Steam Combined Cycle Geothermal Hydro 51 650 127 676 130 1,100 136 1,250 298 1,440 371 462 43 465 156 469 723 525 446 527 100 603 889 1,751 897 176 972 992 15 1060 1250 539 1252 236 1291 1353 1,060 1372 36 1564 1594 1682 105 1771 26 1832 156 1859 24 1880 22 1918 47 1973 2018 21 2051 2078 2451 1,614 2502 2517 2716 176 2914 27 2942 16 2953 2964 2965 3118 1,700 3122 1,884 3136 1,700 3179 1,500 3287 252 3334 3438 3439 3442 3455 3464 3493 3644 175 3648 3775 690 3845 1,340 3943 1,107 3948 1,600 4005 4162 700 4940 4941 2,250 6002 2,680 6009 1,659 6018 600 6021 1,264 6031 600 6041 800 6071 435 6089 44 6090 2,295 6137 500 6170 1,200 6238 22 6246 838 6249 1,080 6250 745 6254 714 6264 1,300 6462 6639 450 6641 1,678 6772 408 6823 416 7213 882 8066 2,080 8069 845 8073 493 8222 421 9864 3 10043 200 10151 84 10354 36 10464 44 10567 44 10766 14 10773 57 50884 50885 50888 102 50951 50 50974 82 50976 294 52007 122 54035 167 54304 199 54689 41 54755 52 Grand Total 36 51,988 1,502 41 3 Biomass Coal Steam Combined CyclGeothermal Hydro Non Fossil Waste Nuclear O/ G Steam Turbine Grand Total Max Generation ( MW) 650 114 650 676 113 676 1,100 112 1,100 1,250 111 1,250 1,440 110 1,440 1,112 1,112 109 1,112 43 108 43 156 107 156 6 729 106 723 446 105 446 100 104 100 550 550 103 550 1,751 102 1,751 10 186 101 176 26 5 31 100 26 4 19 99 15 520 520 98 520 26 565 97 539 39 275 96 236 10 31 41 95 31 1,060 94 1,060 2 38 93 36 151 17 168 92 151 13 13 91 13 26 131 90 105 26 89 26 156 88 156 4 28 87 24 4 26 86 22 47 85 47 24 13 37 84 24 7 29 83 21 207 207 82 207 73 73 81 73 1,614 80 1,614 163 163 79 163 467 16 483 78 467 138 314 77 176 18 45 76 27 11 27 75 16 497 64 561 74 497 475 2 477 73 475 415 8 423 72 415 11 1,711 71 1,700 1,884 70 1,884 11 1,711 69 1,700 1,500 68 1,500 252 67 252 61 61 66 61 182 182 65 182 180 180 64 180 208 47 255 63 208 327 327 62 327 406 354 760 61 406 80 80 60 80 175 59 175 235 235 58 235 690 57 690 1,340 56 1,340 1,107 55 1,107 1,600 54 1,600 29 142 171 53 142 700 52 700 916 3 919 51 916 2,250 50 2,250 2,680 49 2,680 1,659 48 1,659 600 47 600 1,264 46 1,264 18 618 45 600 800 44 800 435 43 435 44 42 44 2,295 41 2,295 80 580 40 500 2 1,202 39 1,200 22 44 38 22 838 37 838 1,080 36 1,080 745 35 745 714 34 714 1,300 33 1,300 980 980 32 980 450 31 450 1,678 30 1,678 408 29 408 416 28 416 882 27 882 2,080 26 2,080 845 25 845 493 24 493 421 23 421 23 25 22 23 200 21 200 84 20 84 36 19 36 44 18 44 44 17 44 14 16 14 57 15 57 65 65 14 65 12 12 13 12 102 12 102 50 11 50 82 10 82 294 9 294 122 8 122 167 7 167 199 6 199 41 5 41 52 4 52 77 2,612 5,785 1,073 63,117 3 2 Non Fossil WaNuclear O/ G Steam Turbine Grand Total 1 Plant Type Max Steam Generation ( MW) Plant Type  Steam Total Steam Capacity ( MW) Coal Steam 650 Coal Steam 650 Coal Steam 676 Coal Steam 676 Coal Steam 1,100 Coal Steam 1,100 Coal Steam 1,250 Coal Steam 1,250 Coal Steam 1,440 Coal Steam 1,440 Nuclear 1,112 Nuclear 1,112 Coal Steam 43 Coal Steam 43 Coal Steam 156 Coal Steam 156 Coal Steam 723 Coal Steam 723 Coal Steam 446 Coal Steam 446 Coal Steam 100 Coal Steam 100 O/ G Steam 550 O/ G Steam 550 Coal Steam 1,751 Coal Steam 1,751 Coal Steam 176 Coal Steam 176 O/ G Steam 26 O/ G Steam 26 Coal Steam 15 Coal Steam 19 Nuclear 520 Nuclear 520 Coal Steam 539 Coal Steam 565 Coal Steam 236 Coal Steam 236 Turbine 10 O/ G Steam 10 Coal Steam 1,060 Coal Steam 1,060 Coal Steam 36 Coal Steam 36 O/ G Steam 151 O/ G Steam 151 O/ G Steam 13 O/ G Steam 13 Combined Cycle 105 Combined Cycle 131 Coal Steam 26 Coal Steam 26 Coal Steam 156 Coal Steam 156 Coal Steam 24 Coal Steam 28 Combined Cycle 22 Combined Cycle 22 Coal Steam 47 Coal Steam 47 O/ G Steam 24 O/ G Steam 24 Coal Steam 21 Coal Steam 29 O/ G Steam 207 O/ G Steam 207 O/ G Steam 73 O/ G Steam 73 Coal Steam 1,614 Coal Steam 1,614 O/ G Steam 163 O/ G Steam 163 O/ G Steam 467 O/ G Steam 467 Coal Steam 176 Coal Steam 176 Coal Steam 27 Coal Steam 27 Coal Steam 16 Coal Steam 16 O/ G Steam 497 O/ G Steam 497 O/ G Steam 475 O/ G Steam 475 O/ G Steam 415 O/ G Steam 415 Coal Steam 1,700 Coal Steam 1,700 Coal Steam 1,884 Coal Steam 1,884 Coal Steam 1,700 Coal Steam 1,700 Coal Steam 1,500 Coal Steam 1,500 Coal Steam 252 Coal Steam 252 O/ G Steam 61 O/ G Steam 61 O/ G Steam 182 O/ G Steam 182 O/ G Steam 180 O/ G Steam 180 O/ G Steam 208 O/ G Steam 208 O/ G Steam 327 O/ G Steam 327 O/ G Steam 406 O/ G Steam 406 O/ G Steam 80 O/ G Steam 80 Coal Steam 175 Coal Steam 175 O/ G Steam 235 O/ G Steam 235 Coal Steam 690 Coal Steam 690 Coal Steam 1,340 Coal Steam 1,340 Coal Steam 1,107 Coal Steam 1,107 Coal Steam 1,600 Coal Steam 1,600 Turbine 29 O/ G Steam 29 Coal Steam 700 Coal Steam 700 O/ G Steam 916 O/ G Steam 916 Coal Steam 2,250 Coal Steam 2,250 Coal Steam 2,680 Coal Steam 2,680 Coal Steam 1,659 Coal Steam 1,659 Coal Steam 600 Coal Steam 600 Coal Steam 1,264 Coal Steam 1,264 Coal Steam 600 Coal Steam 600 Coal Steam 800 Coal Steam 800 Coal Steam 435 Coal Steam 435 Coal Steam 44 Coal Steam 44 Coal Steam 2,295 Coal Steam 2,295 Coal Steam 500 Coal Steam 500 Coal Steam 1,200 Coal Steam 1,200 Coal Steam 22 Coal Steam 22 Combined Cycle 838 Combined Cycle 838 Coal Steam 1,080 Coal Steam 1,080 Coal Steam 745 Coal Steam 745 Coal Steam 714 Coal Steam 714 Coal Steam 1,300 Coal Steam 1,300 Nuclear 980 Nuclear 980 Coal Steam 450 Coal Steam 450 Coal Steam 1,678 Coal Steam 1,678 Coal Steam 408 Coal Steam 408 Coal Steam 416 Coal Steam 416 Coal Steam 882 Coal Steam 882 Coal Steam 2,080 Coal Steam 2,080 Coal Steam 845 Coal Steam 845 Combined Cycle 493 Combined Cycle 493 Coal Steam 421 Coal Steam 421 O/ G Steam 23 O/ G Steam 23 Coal Steam 200 Coal Steam 200 Coal Steam 84 Coal Steam 84 Biomass 36 Biomass 36 Coal Steam 44 Coal Steam 44 Combined Cycle 44 Combined Cycle 44 Coal Steam 14 Coal Steam 14 Coal Steam 57 Coal Steam 57 Non Fossil Waste 65 Non Fossil Waste 65 Non Fossil Waste 12 Non Fossil Waste 12 Coal Steam 102 Coal Steam 102 Coal Steam 50 Coal Steam 50 Coal Steam 82 Coal Steam 82 Coal Steam 294 Coal Steam 294 Coal Steam 122 Coal Steam 122 Coal Steam 167 Coal Steam 167 Coal Steam 199 Coal Steam 199 Geothermal 41 Geothermal 41 Coal Steam 52 Coal Steam 52 Unique Id Plant ID Unit ID Plant Name 51_ B_ 1 51 1 DOLET HILLS 127_ B_ 1 127 1 OKLAUNION 130_ B_ 1 130 1 CROSS 130_ B_ 2 130 2 CROSS 136_ B_ 1 136 1 SEMINOLE 136_ B_ 2 136 2 SEMINOLE 298_ B_ LIM1 298 LIM1 LIMESTONE 298_ B_ LIM2 298 LIM2 LIMESTONE 371_ B_ 1N 371 1N WNP 2 NUCLEAR 462_ B_ 55 462 55 W N CLARK 462_ B_ 59 462 59 W N CLARK 465_ B_ 3 465 3 ARAPAHOE 465_ B_ 4 465 4 ARAPAHOE 469_ B_ 1 469 1 CHEROKEE 469_ B_ 2 469 2 CHEROKEE 469_ B_ 3 469 3 CHEROKEE 469_ B_ 4 469 4 CHEROKEE 469_ G_ IC1 469 IC1 Cherokee 469_ G_ IC2 469 IC2 Cherokee 525_ B_ H1 525 H1 HAYDEN 525_ B_ H2 525 H2 HAYDEN 527_ B_ 1 527 1 NUCLA 603_ B_ 15 603 15 BENNING 603_ B_ 16 603 16 BENNING 889_ B_ 1 889 1 BALDWIN 889_ B_ 2 889 2 BALDWIN 889_ B_ 3 889 3 BALDWIN 897_ B_ 1 897 1 VERMILION 897_ B_ 2 897 2 VERMILION 897_ G_ GT1 897 GT1 Vermilion 972_ B_ 4 972 4 WINNETKA 972_ B_ 5 972 5 WINNETKA 972_ B_ 6 972 6 WINNETKA 972_ B_ 7 972 7 WINNETKA 972_ G_ 8 972 8 Winnetka 972_ B_ 8 972 8 WINNETKA 972_ G_ 9 972 9 Winnetka 992_ B_ 11 992 11 PERRY K 992_ B_ 12 992 12 PERRY K 992_ B_ 13 992 13 PERRY K 992_ B_ 14 992 14 PERRY K 992_ B_ 15 992 15 PERRY K 992_ B_ 16 992 16 PERRY K 992_ B_ 17 992 17 PERRY K 992_ B_ 18 992 18 PERRY K 992_ G_ HS 992 HS Perry K 1060_ B_ 1 1060 1 DUANE ARNOLD NUCLEAR 1250_ B_ 2 1250 2 LAWRENCE 1250_ B_ 3 1250 3 LAWRENCE 1250_ B_ 4 1250 4 LAWRENCE 1250_ B_ 5 1250 5 LAWRENCE 1252_ G_ 1 1252 1 Tecumseh EC 1252_ B_ 10 1252 10 TECUMSEH 1252_ G_ 2 1252 2 Tecumseh EC 1252_ B_ 9 1252 9 TECUMSEH 1291_ G_ 1 1291 1 Iola 1291_ G_ 10 1291 10 Iola 1291_ G_ 11 1291 11 Iola 1291_ G_ 12 1291 12 Iola 1291_ G_ 13 1291 13 Iola 1291_ B_ 15552 1291 15552 IOLA 1291_ B_ 19505 1291 19505 IOLA 1291_ G_ 2 1291 2 Iola 1291_ G_ 6 1291 6 Iola 1291_ G_ 7 1291 7 Iola 1291_ G_ 8 1291 8 Iola 1291_ G_ 9 1291 9 Iola 1353_ B_ BSU1 1353 BSU1 BIG SANDY 1353_ B_ BSU2 1353 BSU2 BIG SANDY 1372_ G_ 1 1372 1 Henderson I 1372_ G_ 2 1372 2 Henderson I 1372_ B_ 5 1372 5 HENDERSON I 1372_ B_ 6 1372 6 HENDERSON I 1564_ G_ 10 1564 10 Vienna 1564_ B_ 8 1564 8 VIENNA 1594_ B_ 11 1594 11 BLACKSTONE STREET 1594_ B_ 12 1594 12 BLACKSTONE STREET 1594_ B_ 5 1594 5 BLACKSTONE STREET 1594_ B_ 6 1594 6 BLACKSTONE STREET 1682_ B_ 8 1682 8 CLEARY FLOOD 1682_ B_ 9 1682 9 CLEARY FLOOD 1682_ G_ 9A 1682 9A Cleary Flood 1771_ B_ 1 1771 1 ESCANABA 1771_ B_ 2 1771 2 ESCANABA 1832_ B_ 1 1832 1 ERICKSON 1859_ B_ 1 1859 1 BAYSIDE 1859_ B_ 2 1859 2 BAYSIDE 1859_ B_ 3 1859 3 BAYSIDE 1859_ B_ 4 1859 4 BAYSIDE 1880_ G_ 5 1880 5 Claude Vandyke 1880_ G_ 6 1880 6 Claude Vandyke 1880_ G_ 7 1880 7 Claude Vandyke 1918_ B_ 4 1918 4 MINNESOTA VALLEY 1973_ B_ 1 1973 1 FAIRMONT 1973_ B_ 2 1973 2 FAIRMONT 1973_ B_ 3 1973 3 FAIRMONT 1973_ B_ 4 1973 4 FAIRMONT 1973_ G_ 6 1973 6 Fairmont 1973_ G_ 7 1973 7 Fairmont 2018_ B_ 10 2018 10 VIRGINIA 2018_ B_ 7 2018 7 VIRGINIA 2018_ B_ 8 2018 8 VIRGINIA 2018_ B_ 9 2018 9 VIRGINIA 2051_ B_ 1 2051 1 DELTA 2051_ B_ 2 2051 2 DELTA 2078_ G_ 7 2078 7 Grand Avenue 2078_ G_ 9 2078 9 Grand Avenue 2451_ B_ 1 2451 1 SAN JUAN 2451_ B_ 2 2451 2 SAN JUAN 2451_ B_ 3 2451 3 SAN JUAN 2451_ B_ 4 2451 4 SAN JUAN 2502_ B_ 61 2502 61 WATERSIDE 2502_ B_ 62 2502 62 WATERSIDE 2502_ B_ 80 2502 80 WATERSIDE 2502_ B_ 90 2502 90 WATERSIDE 2517_ B_ 1 2517 1 PORT JEFFERSON 2517_ B_ 2 2517 2 PORT JEFFERSON 2517_ B_ 3 2517 3 PORT JEFFERSON 2517_ B_ 4 2517 4 PORT JEFFERSON 2517_ G_ GT1 2517 GT1 Port Jefferson 2716_ B_ 1 2716 1 W H WEATHERSPOON 2716_ B_ 2 2716 2 W H WEATHERSPOON 2716_ B_ 3 2716 3 W H WEATHERSPOON 2716_ G_ GT1 2716 GT1 W H Weatherspoon 2716_ G_ GT2 2716 GT2 W H Weatherspoon 2716_ G_ GT3 2716 GT3 W H Weatherspoon 2716_ G_ GT4 2716 GT4 W H Weatherspoon 2914_ G_ 2 2914 2 Dover 2914_ G_ 3 2914 3 Dover 2914_ B_ 4 2914 4 DOVER 2914_ G_ 5 2914 5 Dover 2914_ G_ 6 2914 6 Dover 2942_ B_ 5 2942 5 ST MARYS 2942_ B_ 6 2942 6 ST MARYS 2942_ G_ AUX 2942 AUX St Marys 2942_ G_ GT1 2942 GT1 St Marys 2953_ B_ 1 2953 1 MUSTANG 2953_ B_ 2 2953 2 MUSTANG 2953_ B_ 3 2953 3 MUSTANG 2953_ B_ 4 2953 4 MUSTANG 2953_ G_ 5A 2953 5A Mustang 2953_ G_ 5B 2953 5B Mustang 2964_ B_ 8002 2964 8002 SOUTHWESTERN 2964_ B_ 8003 2964 8003 SOUTHWESTERN 2964_ B_ 801N 2964 801N SOUTHWESTERN 2964_ B_ 801S 2964 801S SOUTHWESTERN 2964_ G_ IC1 2964 IC1 Southwestern 2965_ B_ 1402 2965 1402 TULSA 2965_ B_ 1403 2965 1403 TULSA 2965_ B_ 1404 2965 1404 TULSA 2965_ G_ IC1 2965 IC1 Tulsa 3118_ B_ 1 3118 1 CONEMAUGH 3118_ B_ 2 3118 2 CONEMAUGH 3118_ G_ A 3118 A Conemaugh 3118_ G_ B 3118 B Conemaugh 3118_ G_ C 3118 C Conemaugh 3118_ G_ D 3118 D Conemaugh 3122_ B_ 1 3122 1 HOMER CITY 3122_ B_ 2 3122 2 HOMER CITY 3122_ B_ 3 3122 3 HOMER CITY 3136_ B_ 1 3136 1 KEYSTONE 3136_ B_ 2 3136 2 KEYSTONE 3136_ G_ 3 3136 3 Keystone 3136_ G_ 4 3136 4 Keystone 3136_ G_ 5 3136 5 Keystone 3136_ G_ 6 3136 6 Keystone 3179_ B_ 1 3179 1 HATFIELD'S FERRY 3179_ B_ 2 3179 2 HATFIELD'S FERRY 3179_ B_ 3 3179 3 HATFIELD'S FERRY 3287_ B_ MCM1 3287 MCM1 MCMEEKIN 3287_ B_ MCM2 3287 MCM2 MCMEEKIN 3334_ B_ 11 3334 11 PATHFINDER 3334_ B_ 12 3334 12 PATHFINDER 3334_ B_ 13 3334 13 PATHFINDER 3438_ B_ 1 3438 1 J L BATES 3438_ B_ 2 3438 2 J L BATES 3439_ B_ 1 3439 1 LAREDO 3439_ B_ 2 3439 2 LAREDO 3439_ B_ 3 3439 3 LAREDO 3442_ B_ 5 3442 5 LA PALMA 3442_ B_ 6 3442 6 LA PALMA 3442_ G_ 7 3442 7 La Palma 3442_ B_ 7 3442 7 LA PALMA 3455_ B_ 1 3455 1 PARKDALE 3455_ B_ 2 3455 2 PARKDALE 3455_ B_ 3 3455 3 PARKDALE 3464_ G_ 73 3464 73 Greens Bayou 3464_ G_ 74 3464 74 Greens Bayou 3464_ G_ 81 3464 81 Greens Bayou 3464_ G_ 82 3464 82 Greens Bayou 3464_ G_ 83 3464 83 Greens Bayou 3464_ G_ 84 3464 84 Greens Bayou 3464_ B_ GBY5 3464 GBY5 GREENS BAYOU 3493_ B_ 4 3493 4 NORTH MAIN 3644_ B_ 1 3644 1 CARBON 3644_ B_ 2 3644 2 CARBON 3648_ B_ 1 3648 1 GADSBY 3648_ B_ 2 3648 2 GADSBY 3648_ B_ 3 3648 3 GADSBY 3775_ B_ 1 3775 1 CLINCH RIVER 3775_ B_ 2 3775 2 CLINCH RIVER 3775_ B_ 3 3775 3 CLINCH RIVER 3845_ B_ BW21 3845 BW21 CENTRALIA 3845_ B_ BW22 3845 BW22 CENTRALIA 3943_ B_ 1 3943 1 FORT MARTIN 3943_ B_ 2 3943 2 FORT MARTIN 3948_ B_ 1 3948 1 MITCHELL 3948_ B_ 2 3948 2 MITCHELL 4005_ B_ 1 4005 1 FRENCH ISLAND 4005_ B_ 2 4005 2 FRENCH ISLAND 4005_ G_ 3 4005 3 French Island 4005_ G_ 4 4005 4 French Island 4162_ B_ 1 4162 1 NAUGHTON 4162_ B_ 2 4162 2 NAUGHTON 4162_ B_ 3 4162 3 NAUGHTON 4940_ B_ 1501 4940 1501 RIVERSIDE 4940_ B_ 1502 4940 1502 RIVERSIDE 4940_ G_ IC1 4940 IC1 Riverside 4941_ B_ 1 4941 1 NAVAJO 4941_ B_ 2 4941 2 NAVAJO 4941_ B_ 3 4941 3 NAVAJO 6002_ B_ 1 6002 1 JAMES H MILLER JR 6002_ B_ 2 6002 2 JAMES H MILLER JR 6002_ B_ 3 6002 3 JAMES H MILLER JR 6002_ B_ 4 6002 4 JAMES H MILLER JR 6009_ B_ 1 6009 1 WHITE BLUFF 6009_ B_ 2 6009 2 WHITE BLUFF 6018_ B_ 2 6018 2 EAST BEND 6021_ B_ C1 6021 C1 CRAIG 6021_ B_ C2 6021 C2 CRAIG 6021_ B_ C3 6021 C3 CRAIG 6031_ B_ 2 6031 2 KILLEN STATION 6031_ G_ GT1 6031 GT1 Killen Station 6041_ B_ 1 6041 1 H L SPURLOCK 6041_ B_ 2 6041 2 H L SPURLOCK 6071_ B_ 1 6071 1 TRIMBLE COUNTY 6089_ B_ B1 6089 B1 LEWIS & CLARK 6090_ B_ 1 6090 1 SHERBURNE COUNTY 6090_ B_ 2 6090 2 SHERBURNE COUNTY 6090_ B_ 3 6090 3 SHERBURNE COUNTY 6137_ B_ 1 6137 1 A B BROWN 6137_ B_ 2 6137 2 A B BROWN 6137_ G_ 4 6137 4 A B Brown 6170_ B_ 1 6170 1 PLEASANT PRAIRIE 6170_ B_ 2 6170 2 PLEASANT PRAIRIE 6170_ G_ 3 6170 3 Pleasant Prairie 6238_ B_ 1A 6238 1A PEARL STATION 6238_ G_ GT1 6238 GT1 Pearl Station 6246_ G_ 1GT1 6246 1GT1 Putnam 6246_ G_ 1GT2 6246 1GT2 Putnam 6246_ G_ 2GT1 6246 2GT1 Putnam 6246_ G_ 2GT2 6246 2GT2 Putnam 6246_ B_ HRSG11 6246 HRSG11 PUTNAM 6246_ B_ HRSG12 6246 HRSG12 PUTNAM 6246_ B_ HRSG21 6246 HRSG21 PUTNAM 6246_ B_ HRSG22 6246 HRSG22 PUTNAM 6249_ B_ 1 6249 1 WINYAH 6249_ B_ 2 6249 2 WINYAH 6249_ B_ 3 6249 3 WINYAH 6249_ B_ 4 6249 4 WINYAH 6250_ B_ 1A 6250 1A MAYO 6250_ B_ 1B 6250 1B MAYO 6254_ B_ 1 6254 1 OTTUMWA 6264_ B_ 1 6264 1 MOUNTAINEER 6462_ B_ 1N 6462 1N RIVER BEND NUCLEAR 6639_ B_ G1 6639 G1 R D GREEN 6639_ B_ G2 6639 G2 R D GREEN 6641_ B_ 1 6641 1 INDEPENDENCE 6641_ B_ 2 6641 2 INDEPENDENCE 6772_ B_ 1 6772 1 HUGO 6823_ B_ W1 6823 W1 D B WILSON 7213_ B_ 1 7213 1 CLOVER 7213_ B_ 2 7213 2 CLOVER 8066_ B_ BW71 8066 BW71 JIM BRIDGER 8066_ B_ BW72 8066 BW72 JIM BRIDGER 8066_ B_ BW73 8066 BW73 JIM BRIDGER 8066_ B_ BW74 8066 BW74 JIM BRIDGER 8069_ B_ 1 8069 1 HUNTINGTON 8069_ B_ 2 8069 2 HUNTINGTON 8073_ G_ 1 8073 1 Beaver 8073_ G_ 2 8073 2 Beaver 8073_ G_ 3 8073 3 Beaver 8073_ G_ 4 8073 4 Beaver 8073_ G_ 5 8073 5 Beaver 8073_ G_ 6 8073 6 Beaver 8073_ G_ 7 8073 7 Beaver 8222_ B_ B1 8222 B1 COYOTE 9864_ G_ 1 9864 1 Cabot Holyoke 9864_ G_ 2 9864 2 Cabot Holyoke 9864_ G_ 3 9864 3 Cabot Holyoke 9864_ G_ 4 9864 4 Cabot Holyoke 9864_ B_ 5 9864 5 CABOT HOLYOKE 9864_ B_ 6 9864 6 CABOT HOLYOKE 10043_ G_ GEN1 10043 GEN1 Logan Generating Plant 10151_ G_ GEN1 10151 GEN1 Grant Town Power Plant 10354_ G_ GEN1 10354 GEN1 Beaver Livermore Falls 10464_ G_ GEN1 10464 GEN1 Fort Drum H T W Cogeneration Facility 10567_ G_ GTG 10567 GTG Dexter Cogeneration Facility 10567_ G_ STG 10567 STG Dexter Cogeneration Facility 10766_ G_ GEN1 10766 GEN1 Indeck West Enfield Energy Center 10773_ G_ GEN1 10773 GEN1 LG& E Westmoreland Altavista 50884_ G_ GEN1 50884 GEN1 Pinellas County Resource Recovery 50884_ G_ GEN2 50884 GEN2 Pinellas County Resource Recovery 50885_ G_ GEN1 50885 GEN1 Wheelabrator Gloucester Company L P 50888_ G_ GEN1 50888 GEN1 Northhampton Generating Company L P 50951_ G_ GEN1 50951 GEN1 Sunnyside Cogeneration Associates 50974_ G_ GEN1 50974 GEN1 Scrubgrass Generating Company L P 50976_ G_ GEN1 50976 GEN1 Indiantown Cogeneration Facility 52007_ G_ GEN1 52007 GEN1 Mecklenburg Cogeneration Facility 52007_ G_ GEN2 52007 GEN2 Mecklenburg Cogeneration Facility 54035_ G_ GEN1 54035 GEN1 Westmoreland LG& E Partners Roanoke Valley 1 54304_ G_ 1 54304 1 SEI Birchwood Power Facility 54689_ G_ 1 54689 1 Heber Geothermal Company 54755_ G_ GEN2 54755 GEN2 Westmoreland LG& E Partners Roanoke Valley II NERC Region Capacity MW PlantType SPP 650 Coal Steam ERCOT 676 Coal Steam SERC 560 Coal Steam SERC 540 Coal Steam FRCC 625 Coal Steam FRCC 625 Coal Steam ERCOT 720 Coal Steam ERCOT 720 Coal Steam WSCC 1112 Nuclear WSCC 19 Coal Steam WSCC 24 Coal Steam WSCC 45 Coal Steam WSCC 111 Coal Steam WSCC 107 Coal Steam WSCC 106 Coal Steam WSCC 158 Coal Steam WSCC 352 Coal Steam WSCC 2.75 Turbine WSCC 2.75 Turbine WSCC 184 Coal Steam WSCC 262 Coal Steam WSCC 100 Coal Steam MAAC 275 O/ G Steam MAAC 275 O/ G Steam MAIN 575 Coal Steam MAIN 581 Coal Steam MAIN 595 Coal Steam MAIN 74 Coal Steam MAIN 102 Coal Steam MAIN 10 Turbine MAIN 5.24 O/ G Steam MAIN 5.24 O/ G Steam MAIN 5.24 O/ G Steam MAIN 5.24 O/ G Steam MAIN 2.410000086 Turbine MAIN 5.24 O/ G Steam MAIN 2.410000086 Turbine ECAR 2 Coal Steam ECAR 2 Coal Steam ECAR 2 Coal Steam ECAR 2 Coal Steam ECAR 2 Coal Steam ECAR 2 Coal Steam ECAR 2 O/ G Steam ECAR 2 O/ G Steam ECAR 3 Coal Steam MAPP 520 Nuclear SPP 26 O/ G Steam SPP 56 Coal Steam SPP 113 Coal Steam SPP 370 Coal Steam SPP 19 Turbine SPP 148 Coal Steam SPP 20 Turbine SPP 88 Coal Steam SPP 5.05 Turbine SPP 2.910000086 Turbine SPP 2.191999912 Turbine SPP 2.022000074 Turbine SPP 2.065000057 Turbine SPP 4.385 O/ G Steam SPP 5.349999905 O/ G Steam SPP 5.05 Turbine SPP 2.95 Turbine SPP 2.900000095 Turbine SPP 2.970000029 Turbine SPP 2.974999905 Turbine ECAR 260 Coal Steam ECAR 800 Coal Steam ECAR 1 Turbine ECAR 1 Turbine ECAR 10 Coal Steam ECAR 26 Coal Steam MAAC 17 Turbine MAAC 151 O/ G Steam NPCC 3.325 O/ G Steam NPCC 3.325 O/ G Steam NPCC 3.325 O/ G Steam NPCC 3.325 O/ G Steam NPCC 26 O/ G Steam NPCC 87 Combined Cycle NPCC 18 Combined Cycle MAIN 13.08300018 Coal Steam MAIN 13.17399979 Coal Steam ECAR 155.75 Coal Steam ECAR 4.216666667 Coal Steam ECAR 4.216666667 Coal Steam ECAR 4.216666667 O/ G Steam ECAR 15.125 Coal Steam ECAR 3 Turbine ECAR 22 Combined Cycle ECAR 1 Turbine MAPP 47 Coal Steam MAPP 5.961 O/ G Steam MAPP 5.961 O/ G Steam MAPP 5.961 O/ G Steam MAPP 5.961 O/ G Steam MAPP 6.743999958 Turbine MAPP 6.546000004 Turbine MAPP 7.125 O/ G Steam MAPP 7.125 Coal Steam MAPP 7.125 Coal Steam MAPP 7.125 Coal Steam SERC 104 O/ G Steam SERC 103 O/ G Steam SPP 36 O/ G Steam SPP 37 O/ G Steam WSCC 316 Coal Steam WSCC 312 Coal Steam WSCC 488 Coal Steam WSCC 498 Coal Steam NPCC 35.01861131 O/ G Steam NPCC 33.98138869 O/ G Steam NPCC 47 O/ G Steam NPCC 47 O/ G Steam NPCC 42.284 O/ G Steam NPCC 42.284 O/ G Steam NPCC 191 O/ G Steam NPCC 191 O/ G Steam NPCC 16 Turbine SERC 49 Coal Steam SERC 49 Coal Steam SERC 78 Coal Steam SERC 35 Turbine SERC 35 Turbine SERC 34 Turbine SERC 34 Turbine ECAR 4 Coal Steam ECAR 8 Coal Steam ECAR 15.19999981 Coal Steam ECAR 2.4 Turbine ECAR 15.3 Turbine ECAR 5.8 Coal Steam ECAR 10 Coal Steam ECAR 0.75 Turbine ECAR 10.4 Turbine SPP 58 O/ G Steam SPP 57 O/ G Steam SPP 122 O/ G Steam SPP 260 O/ G Steam SPP 32 Turbine SPP 32 Turbine SPP 80 O/ G Steam SPP 315 O/ G Steam SPP 40 O/ G Steam SPP 40 O/ G Steam SPP 2 Turbine SPP 165 O/ G Steam SPP 85 O/ G Steam SPP 165 O/ G Steam SPP 8.25 Turbine MAAC 850 Coal Steam MAAC 850 Coal Steam MAAC 2.7 Turbine MAAC 2.7 Turbine MAAC 2.7 Turbine MAAC 2.7 Turbine MAAC 620 Coal Steam MAAC 614 Coal Steam MAAC 650 Coal Steam MAAC 850 Coal Steam MAAC 850 Coal Steam MAAC 2.7 Turbine MAAC 2.7 Turbine MAAC 2.7 Turbine MAAC 2.7 Turbine ECAR 500 Coal Steam ECAR 500 Coal Steam ECAR 500 Coal Steam SERC 126 Coal Steam SERC 126 Coal Steam MAPP 42.83201218 O/ G Steam MAPP 9.083994865 O/ G Steam MAPP 9.083994865 O/ G Steam ERCOT 72 O/ G Steam ERCOT 110 O/ G Steam ERCOT 35 O/ G Steam ERCOT 34 O/ G Steam ERCOT 111 O/ G Steam ERCOT 25 O/ G Steam ERCOT 25 O/ G Steam ERCOT 47 Turbine ERCOT 158 O/ G Steam ERCOT 87 O/ G Steam ERCOT 115 O/ G Steam ERCOT 125 O/ G Steam ERCOT 54 Turbine ERCOT 54 Turbine ERCOT 54 Turbine ERCOT 64 Turbine ERCOT 64 Turbine ERCOT 64 Turbine ERCOT 406 O/ G Steam ERCOT 80 O/ G Steam WSCC 70 Coal Steam WSCC 105 Coal Steam WSCC 60 O/ G Steam WSCC 75 O/ G Steam WSCC 100 O/ G Steam ECAR 230 Coal Steam ECAR 230 Coal Steam ECAR 230 Coal Steam WSCC 670 Coal Steam WSCC 670 Coal Steam ECAR 552 Coal Steam ECAR 555 Coal Steam ECAR 800 Coal Steam ECAR 800 Coal Steam MAPP 14.5 O/ G Steam MAPP 14.5 O/ G Steam MAPP 71 Turbine MAPP 71 Turbine WSCC 160 Coal Steam WSCC 210 Coal Steam WSCC 330 Coal Steam SPP 457 O/ G Steam SPP 459 O/ G Steam SPP 3 Turbine WSCC 750 Coal Steam WSCC 750 Coal Steam WSCC 750 Coal Steam SERC 670 Coal Steam SERC 669 Coal Steam SERC 675 Coal Steam SERC 666 Coal Steam SERC 815 Coal Steam SERC 844 Coal Steam ECAR 600 Coal Steam WSCC 428 Coal Steam WSCC 428 Coal Steam WSCC 408 Coal Steam ECAR 600 Coal Steam ECAR 18 Turbine ECAR 300 Coal Steam ECAR 500 Coal Steam ECAR 434.75 Coal Steam MAPP 43.79999924 Coal Steam MAPP 712 Coal Steam MAPP 712 Coal Steam MAPP 871 Coal Steam ECAR 250 Coal Steam ECAR 250 Coal Steam ECAR 80 Turbine MAIN 600 Coal Steam MAIN 600 Coal Steam MAIN 2 Turbine MAIN 22 Coal Steam MAIN 22 Turbine FRCC 85 Combined Cycle FRCC 85 Combined Cycle FRCC 85 Combined Cycle FRCC 85 Combined Cycle FRCC 124.5 Combined Cycle FRCC 124.5 Combined Cycle FRCC 124.5 Combined Cycle FRCC 124.5 Combined Cycle SERC 270 Coal Steam SERC 270 Coal Steam SERC 270 Coal Steam SERC 270 Coal Steam SERC 372.4999695 Coal Steam SERC 372.5 Coal Steam MAPP 714 Coal Steam ECAR 1300 Coal Steam SERC 980 Nuclear ECAR 228.9039272 Coal Steam ECAR 220.9765185 Coal Steam SERC 836 Coal Steam SERC 842 Coal Steam SPP 408 Coal Steam ECAR 416.0636248 Coal Steam SERC 441 Coal Steam SERC 441 Coal Steam WSCC 520 Coal Steam WSCC 520 Coal Steam WSCC 520 Coal Steam WSCC 520 Coal Steam WSCC 420 Coal Steam WSCC 425 Coal Steam WSCC 58.66600037 Combined Cycle WSCC 58.66600037 Combined Cycle WSCC 58.66600037 Combined Cycle WSCC 58.66600037 Combined Cycle WSCC 58.66600037 Combined Cycle WSCC 58.66600037 Combined Cycle WSCC 141 Combined Cycle MAPP 421 Coal Steam NPCC 0.800000012 Hydro NPCC 0.800000012 Hydro NPCC 0.400000006 Hydro NPCC 0.600000024 Hydro NPCC 11.4 O/ G Steam NPCC 11.4 O/ G Steam MAAC 200.4784604 Coal Steam ECAR 83.75743853 Coal Steam NPCC 36.25127717 Biomass NPCC 44.20102347 Coal Steam NPCC 31.62104547 Combined Cycle NPCC 12.64841819 Combined Cycle NPCC 13.85517151 Coal Steam SERC 57.09003249 Coal Steam FRCC 42.78971368 Non Fossil Waste FRCC 22.02765055 Non Fossil Waste MAAC 11.94179943 Non Fossil Waste MAAC 101.9775928 Coal Steam WSCC 50.27646844 Coal Steam MAAC 82.35942095 Coal Steam FRCC 293.8449981 Coal Steam SERC 61.06118241 Coal Steam SERC 61.06118241 Coal Steam SERC 167.4661757 Coal Steam SERC 198.7176957 Coal Steam WSCC 41.27993427 Geothermal SERC 52.49133012 Coal Steam Phase III Facilities not included in the EPA Base Case 2002 PLNTCODE PLNTNAME 1243 Neosho 50907 Oswego County Energy Recovery Reason for exclusion generators 1 & 2 were retired and the boiler attached to generator 3 has an OS status flag On site generator


CASE STUDY D This example illustrates how to report: 1. a hydrate of a chemical substance; 2. inorganic chemical substances ( partial exemption for 2006 reporting year); 3. TSCA exempt use ( as a pesticide).

Scenario: Company D produces 800,000 lbs/ yr of copper sulfate pentahydrate ( CuSO 4 · 5H 2 O) crystals at 93% purity. 70% of the production volume is used for metal electroplating and 30% is used as pesticides. This site employs 60 workers in the manufacturing area.

Key Points: This material is a hydrate, therefore only the weight fraction of the non hydrated form of copper sulfate ( CuSO 4) ( CAS# 7758 98 7) should be reported. To determine the weight fraction, multiply the production volume of the copper sulfate pentahydrate by the molecular weight of copper sulfate ( CuSO 4) divided by the molecular weight of the copper sulfate pentrahydrate ( CuSO 4 · 5H 2 O). The molecular weight of CuSO 4 is 159.6 lbs/ lb · mole and the molecular weight of CuSO 4 · 5H 2 O is 249.7 lbs/ lb · mole. Calculation:

800,000 lbs CuSO 4 5H 2 O yr 159.6 lbs / lb mole CuSO 4 249.7 lbs / lb mole CuSO 4 5H 2 O 511,386 lbs CuSO 4 / yr   ×

    =

The manufacture and use of pesticides is exempt from TSCA regulations, therefore the portion of the production volume used in pesticides does not need to be reported for Part III. Additionally, copper sulfate is an inorganic substance. For the 2006 reporting year, inorganic substances are partially exempt, so only Parts I and II need to be reported. Company D produces 800,000 lbs. of copper sulfate pentahydrate crystals ( 511,386 lbs. CuSO4) at 93% purity 560,000 lbs. of copper sulfate pentahydrate ( 357,970 lbs. CuSO4) is used for metal electroplating. 240,000 lbs. of copper sulfate pentahydrate ( 153,416 lbs. CuSO4) is used as a pesticide. ( Exempt) MANUFACTURING INDUSTRIAL PROCESSING AND USE CASE STUDY D  Flow Diagram Completing the Form: Part II.  Manufacturing Information Block Block Title Report Basis/ Rationale 1.1 Chemical ID Number 7758 98 7 CAS Number 1.2 ID Code C Code for CAS Number 1.3 Chemical Name Copper ( II) sulfate Chemical Abstracts Index/ Preferred name 2.3 Site limited N Copper sulfate is distributed off site for commercial purposes.

2.4 Activity M Copper sulfate is manufactured and not imported.

2.5 Production Volume ( lbs) 357,970 Calculated amount of anhydrous copper sulfate produced for non pesticidal uses. 511,386 lbs x 70% PV = 357,970 lbs.

2.7 Number of Workers W4 At least 50 but fewer than 100. Company D estimates 60 workers exposed during the manufacturing process, mostly due to cleaning, sampling, handling, and transfer operations.

2.8 Maximum Concentration M5 Greater than 90% by weight. The maximum concentration leaving the site is 93%.

2.10 Physical Form Percent of PV a. Large crystals; b. 100 100% of the product is produced as large crystals.

Part III  Section I. Industrial Processing and Use Information 4. Check the " N/ A" box in the upper right hand corner.

Part III  Section II. Commercial and Consumer End Use Exposure Related Data 5. Check the " N/ A" box in the upper right hand corner. DRAFT: Appendix G Case Studies Form U  CASE STUDY D Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION I. CHEMICAL IDENTIFICATION CBI*

1.1 Chemical Identifying Number 7758 98 7 1.2 ID Code C 1.3 Chemical Name Copper ( II) Sulfate SECTION II. MANUFACTURING INFORMATION 2.1 Company Information CBI 2.2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2.3 Site Limited ( Y/ N) N CBI 2.9 Dry Powder 2.4 Activity ( M, I or both) M CBI 2.10 Pellets or Large Crystals

100 2.5 Production Volume ( LB) 357,970 CBI 2.11 Water or Solvent Wet Solid 2.6 Production Volume Range CBI 2.12 Other Solid 2.7 Number of Workers ( code) W4 CBI 2.13 Gas or Vapor 2.8 Maximum Concentration ( code) M5 CBI 2.14 Liquid PART III. PROCESSING AND USE INFORMATION Complete Part III, Section I and II only if the production volume noted in Part II, Section II, Block 2.5 is greater than or equal to 3,000,000 lb/ year SECTION I. INDUSTRIAL PROCESSING AND USE DATA N/ A

a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 SECTION II. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A

a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 * Substantiation required for CBI claims on chemical identity and plant site identity. REPORT NUMBER DRAFT: Appendix G Case Studies CASE STUDY E This example illustrates how to report: 6. a chemical listed on the " partially exempt chemical substances" list.

Scenario: Company E produces 500,000 lbs/ yr of a benzene, mono C14 16 alkyl derivs. ( 129813 60 1) liquid solution at concentrations up to 95%. Company E distributes 500,000 lbs to twelve companies for formulation into laundry detergents. These detergents are intended for use by approximately 200 commercial companies. Company E has two production lines on this site that produce benzene, mono C14 16 alkyl derivs. Each line employs 20 workers to operate and maintain equipment during manufacturing operations, including sampling, handling, and equipment cleaning.

Key Points: Benzene, mono C14 16 alkyl derivs. is partially exempt from reporting ( see 40 CFR 710.46( b)( 2)( iv) and Appendix E), therefore only Sections I and II need to be completed. The processing and use information in Section III does not need to be completed.

Completing the Form: Part II.  Manufacturing Information Block Block Title Report Basis/ Rationale 1.1 Chemical ID Number 129813 60 1 CAS Number 1.2 ID Code C Code for CAS Number 1.3 Chemical Name Benzene, mono C14 16 alkyl derivs. Chemical Abstracts Index/ Preferred name 2.3 Site limited N Benzene, mono C14 16 alkyl derivs. is distributed off site.

2.4 Activity M Benzene, mono C14 16 alkyl derivs. is manufactured and not imported.

2.5 Production Volume ( lbs) 500,000 Reported to amount reasonably obtainable.

2.7 Number of Workers W2 At least 25 but fewer than 50. Company E estimates 40 workers exposed ( 20 workers per line x 2 lines = 40 workers).

2.8 Maximum Concentration M5 Greater than 90% by weight. The maximum concentration leaving the site is 95%.

2.14 Physical Form Percent of PV a. Liquid; b. 100 100% of the product is produced as liquid formulations and mixtures.

Part III  Section I. Industrial Processing and Use Information 7. Check the " N/ A" box in the upper right hand corner. DRAFT: Appendix G Case Studies Part III  Section II. Commercial and Consumer End Use Exposure Related Data 8. Check the " N/ A" box in the upper right hand corner. DRAFT: Appendix G Case Studies Form U  CASE STUDY E Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION I. CHEMICAL IDENTIFICATION CBI*

1.1 Chemical Identifying Number 129813 60 1 1.2 ID Code C 1.3 Chemical Name Benzene, Mono C14 16 Alkyl Derivs.

SECTION II. MANUFACTURING INFORMATION 2.1 Company Information CBI 2.2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2.3 Site Limited ( Y/ N) N CBI 2.9 Dry Powder 2.4 Activity ( M, I or both) M CBI 2.10 Pellets or Large Crystals 2.5 Production Volume ( LB) 500,000 CBI 2.11 Water or Solvent Wet Solid 2.6 Production Volume Range CBI 2.12 Other Solid 2.7 Number of Workers ( code) W2 CBI 2.13 Gas or Vapor 2.8 Maximum Concentration ( code) M5 CBI 2.14 Liquid

100 PART III. PROCESSING AND USE INFORMATION Complete Part III, Section I and II only if the production volume noted in Part II, Section II, Block 2.5 is greater than or equal to 3,000,000 lb/ year SECTION I. INDUSTRIAL PROCESSING AND USE DATA N/ A

a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 SECTION II. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A

a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 * Substantiation required for CBI claims on chemical identity and plant site identity. REPORT NUMBER DRAFT: Appendix G Case Studies CASE STUDY F This example illustrates how to report: 9. when two different physical forms are manufactured; 10. the use in a children's product; 11. Children's Product Use as " not readily obtainable"; when the sum of the percent production volume is greater than 100%.

Scenario: At one site, Company F manufacturers a total of 800,000 lb/ yr of C. I. Pigment Yellow 100 ( CAS# 12225 21 7) in both powdered and liquid forms. Company F manufactures and sells 300,000 lb/ yr of powdered C. I. Pigment Yellow 100 ( 100% concentration) to 6 sites that incorporate it into plastic pellets at less than 1% concentration. These pellets are then molded into plastic articles which are sold to consumers. The remaining 500,000 pounds of C. I. Pigment Yellow 100 is sold as a liquid at concentrations between 1% and 30% as a coloring agent to approximately 50 paint manufacturers. The paint manufacturers then sell 60% of this paint ( 300,000 lbs.) directly to the consumer and the other 40% to about 10 toy manufacturers that paint wooden toys ( 200,000 lbs.). The furniture and toys are then sold to consumers, including children.

Company F employs 25 workers to manufacture C. I. Pigment Yellow 100 as a powder and an additional 20 workers to manufacture the liquid formulations. Company F estimates that 5 workers are exposed to C. I. Pigment Yellow 100 at each plastic manufacturing site and 5 workers are exposed at each paint manufacturing site. Company F estimates 5 workers are exposed at to C. I. Pigment Yellow 100 at each wooden toy manufacturer site. DRAFT: Appendix G Case Studies 500,000 lbs. of CI Pigment Yellow 100 is sold to 50 paint manufacturers as a coloring agent and is blended into paint formulations at concentrations of 1 30%. ( Block 1.2) 300,000 lbs. of CI Pigment Yellow 100 sold to 6 sites that incorporate it into plastic pellets.

( Block 1.1)

300,000 lbs. is sold directly to the consumer as a component in paint. ( Block 2.2) 200,000 lbs. is sold to 10 toy manufacturers for painting wooden toys. ( Block 2.3) MANUFACTURING COMMERICAL AND CONSUMER END USE Company F produces 500,000 lbs. of powdered CI Pigment Yellow in liquid solution at 1  30% concentration. Company F produces 300,000 lbs. of powdered CI Pigment Yellow 100 at 100% concentration.

Plastic pellets containing CI Pigment Yellow 100 are molded into articles. ( Block 2.1) INDUSTRIAL PROCESSING AND USE CASE STUDY F  Flow Diagram DRAFT: Appendix G Case Studies Completing the Form: Part II.  Manufacturing Information Block Block Title Report Basis/ Rationale 1.1 Chemical ID Number 12225 21 7 CAS Number 1.2 ID Code C Code for CAS Number 1.3 Chemical Name C. I. Pigment Yellow 100 Chemical Abstracts Index/ Preferred name 2.3 Site limited N C. I. Pigment Yellow 100 is distributed off site for commercial purposes.

2.4 Activity M C. I. Pigment Yellow 100 is manufactured and not imported.

2.5 Production Volume ( lbs) 800,000 Reported to amount reasonably obtainable.

2.7 Number of Workers W3 At least 25 but fewer than 50. Company F employs 45 workers to produce C. I. Pigment Yellow 100 ( 25 for powder form and 20 for liquid form).

2.8 Maximum Concentration M5 Greater than 90% by weight. The maximum concentration leaving the site is 100%.

2.9 Physical Form Percent of PV a. Powder; b. 40 300,000 of the total 800,000 pounds ( 37.5%) of product is produced as a powder. Round up to 40%.

2.14 Physical Form Percent of PV a. Liquid; b. 60 500,000 of the total 800,000 pounds ( 62.5%) of product is produced as a liquid. Round down to 60%. DRAFT: Appendix G Case Studies Part III  Section I. Industrial Processing and Use Information Block Block Title Report Basis/ Rationale 1.1 Type of Process or Use PA Incorporation into an article. This accounts for the powder form being incorporated into plastic pellets.

NAICS 32619 Other plastics product manufacturing.

IFC U08 Coloring agents, pigments.

Percent PV 40 37.5% of the production volume is used for this use. Round up to 40%.

Number of Sites S1 Less than 10. Company F has 6 customer sites.

Number of Workers W3 At least 25 but fewer than 50. Company B estimates 5 exposed workers for each of 6 processing sites. 5 workers per site x 6 sites = 30 workers.

1.2 Type of Process or Use PF Incorporation into formulations and mixtures.

NAICS 32551 Paint and coating manufacturing.

IFC U08 Coloring agents, pigments.

Percent PV 60 62.5% of the production volume is used for this use. Round down to 60%.

Number of Sites S3 From 26 to 100. Company F estimates 50 paint manufacturers use their product.

Number of Workers W5 At least 100 but fewer than 500. Company F estimates 5 exposed workers per site for 50 processing sites = 250 of workers.

Part III  Section II. Commercial and Consumer End Use Exposure Related Data Block Block Title Report Basis/ Rationale 2.1 Commercial and Consumer Product Category C15 Rubber and plastics products.

Use in Children's Product ? Information not readily obtainable.

Percent PV 40 40% of C. I. Pigment Yellow 100 manufactured by Company F is used in polymers/ plastics.

Maximum Concentration M1 Less than 1% by weight. DRAFT: Appendix G Case Studies Block Block Title Report Basis/ Rationale 2.2 Commercial and Consumer Product Category C12 Paints and coatings.

Use in Children's Product N Paints sold directly to consumer are not expected to be used by children.

Percent PV 40 37.5% of C. I. Pigment Yellow 100 manufactured by Company F is used in paint. Round up to 40%.

Maximum Concentration M2 From 1% to 30% by weight. The maximum concentration used in formulations is 30%.

2.3 Commercial and Consumer Product Category C18 Wood and wood furniture.

Use in Children's Product Y Wooden toys are expected to be used by children.

Percent PV 30 25% of PV ( 200,000 lbs.) is used in paint for wooden toys. Round up to 30%.

Maximum Concentration M2 From 1% to 30% by weight. The maximum concentration used in formulations is 30%. DRAFT: Appendix G Case Studies Form U  CASE STUDY F Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION I. CHEMICAL IDENTIFICATION CBI*

1.1 Chemical Identifying Number 12225 21 7 1.2 ID Code C 1.3 Chemical Name C. I. Pigment Yellow 100 SECTION II. MANUFACTURING INFORMATION 2.1 Company Information CBI 2.2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2.3 Site Limited ( Y/ N) N CBI 2.9 Dry Powder

40 2.4 Activity ( M, I or both) M CBI 2.10 Pellets or Large Crystals 2.5 Production Volume ( LB) 800,000 CBI 2.11 Water or Solvent Wet Solid 2.6 Production Volume Range CBI 2.12 Other Solid 2.7 Number of Workers ( code) W3 CBI 2.13 Gas or Vapor 2.8 Maximum Concentration ( code) M5 CBI 2.14 Liquid

60 PART III. PROCESSING AND USE INFORMATION Complete Part III, Section I and II only if the production volume noted in Part II, Section II, Block 2.5 is greater than or equal to 3,000,000 lb/ year SECTION I. INDUSTRIAL PROCESSING AND USE DATA N/ A a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 1.1 PA 32619 U08 40 51 W3 1.2 PF 32551 U08 60 53 W5 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 SECTION II. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 2.1 C15 ? 40 M1 2.2 C12 N 40 M2 2.3 C18 Y 30 M2 2.4 2.5 2.6 2.7 2.8 2.9 2.10 * Substantiation required for CBI claims on chemical identity and plant site identity. REPORT NUMBER DRAFT: Appendix G Case Studies CASE STUDY G This example illustrates how to report: 12. a chemical substance that is both manufactured and imported at the same site; 13. multiple Types of Process or Use codes; ° multiple NAICS codes ° multiple IFC codes; ° when the sum of the percent production volume for Industrial Processing is greater than 100%; ° TSCA exempt use ( as a pesticide)

Scenario: Company G produced 19,000,000 pounds of xylene, mixed isomers ( CAS# 1330 20 7) ( referred to as xylene throughout this case study) and imported an additional 1,000,000 pounds during the same reporting year to the same site. The xylene is manufactured at 100% concentration. Company G estimates 8 exposed workers during the manufacture of xylene for sampling and maintenance, in addition to 6 exposed workers during the drumming of product.

Company G distributes 4,000,000 pounds of xylene directly to 3 chemical manufacturing facilities at 100% concentration to be used as a chemical reactant. The remaining 16,000,000 pounds of xylene is shipped to 15 different distributors for formulation of products. The distributors formulate 4,000,000 pounds of xylene and sell it as a metal degreaser at 95% concentration to 200 hardware manufacturers. The formulator dilutes the remaining 12,000,000 pounds such that xylene is present at a concentration ranging between 0.5% and 95% and places the final product into smaller containers. Of the 12,000,000 pounds of xylene that is processed, 6,000,000 pounds is used in automotive care products ( 35% max. conc.) used both commercially and by consumers. 3,200,000 pounds will be used in paint formulations ( 15% max. conc.) which are then sold for commercial and consumer applications. 2,200,000 pounds is formulated into pesticides ( 10% max conc.) which is then sold for commercial use. 400,000 pounds is sold for formulation of a wood preservative ( 20% conc.) to be used on furniture for residential use. 200,000 pounds is sold as a component of solvents on the consumer market ( 95% max conc.).

Key Points: Pesticides are exempt from regulation under TSCA, therefore the use of xylene for the preparation of a commercial pesticide formulation does not need to be included in Form U. The 200,000 lbs. of xylene used as a component of solvents sold to consumers should not be reported in Part III because it is less than 5% of the total production volume and less than the 300,000 pounds threshold. The percent production volumes for use as wood preservatives and paint used by consumers should be reported to the nearest percentage point because it is less than 5% of the production volume and totals 300,000 lbs. or more. DRAFT: Appendix G Case Studies 19,000,000 lbs. xylene produced by Company A at 100% concentration 16,000,000 lbs. shipped to 15 different formulators for formulation and packaging at 0.5%  95%. ( Block 1.2) 4,000,000 lbs. shipped directly to 3 chemical manufactures at 100% concentration for use as a chemical reactant. ( Block 1.1)

Paint sold for commercial and consumer applications. ( Block 2.2) Pesticides sold for commercial and consumer applications. ( Exempt) MANUFACTURING INDUSTRIAL PROCESSING AND USE COMMERICAL AND CONSUMER END USE 1,000,000 lbs. xylene imported by Company A at 100% concentration 4,000,000 lbs. used at 95% concentration as a metal degreaser at 200 hardware manufacturers. ( Block 1.3)

400,000 lbs. sold as a component in wood preservatives at 20% maximum concentration. ( Block 1.5) 2,200,000 lbs. reformulated into pesticides at 10% concentration.

( Exempt)

3,200,000 lbs. reformulated into paint 15% maximum concentration. ( Block 1.4)

6,000,000 lbs. used as a component in automotive care products at 35% maximum concentration. ( Block 2.1) 200,000 lbs. used as a component of solvents sold to consumers at 95% maximum concentration. ( Exempt: Less than 300,000 lbs. and 5% PV) Company A reports 20,000,000 lb. manufactured at 100% concentration.

Applied to residential furniture.

( Block 2.3) CASE STUDY G  Flow Diagram DRAFT: Appendix G Case Studies Completing the Form: Part II  Manufacturing Information Block Block Title Report Basis/ Rationale 1.1 Chemical ID Number 1330 20 7 CAS Number 1.2 ID Code C Code for CAS Number 1.3 Chemical Name Xylene, mixed isomer Chemical Abstracts Index/ Preferred name 2.3 Site limited N Xylene is distributed off site for commercial purposes.

2.4 Activity B Xylene is both manufactured and imported.

2.5 Production Volume ( lbs) 20,000,000 Combined manufacture and import volumes.

2.7 Number of Workers W2 At least 10 but fewer than 25. Company G reports 14 workers are exposed during the manufacture of xylene.

2.8 Maximum Concentration M5 Greater than 90% by weight. The maximum concentration leaving the site is 100%.

2.14 Physical Form Percent of PV a. Liquid; b. 100 100% of the product is manufactured in liquid form. DRAFT: Appendix G Case Studies Part III  Section I. Industrial Processing and Use Information.

Block Block Title Report Basis/ Rationale 1.1 Type of Process or Use PC Processing as a reactant.

NAICS 32519 Other basic organic chemical manufacturing.

IFC U16 Intermediates.

Percent PV 20 20% PV ( 4,000,000 lbs) is distributed directly to 3 chemical manufacturers. 4,000,000 lbs. / 20,000,000 lbs. total = 20%.

Number of Sites S1 Less than 10 sites.

Number of Workers W2 At least 10 but fewer than 25. Company B estimates 4 exposed workers for each of 3 industrial sites. 4 workers per site x 3 sites = 12 workers.

1.2 Type of Process or Use PF Incorporation into formulations and mixtures.

NAICS 32519 Other basic organic chemical manufacturing.

IFC U27 Solvents ( for cleaning or degreasing).

Percent PV 80 80% PV ( 16,000,000 lbs.) is repackaged.

Number of Sites S2 From 10 to 25. Company G distributes xylene to 15 distributor/ repackaging centers.

Number of Workers W4 At least 50 but fewer than 100. Company F estimates 6 exposed workers per site x 15 sites = 90 workers.

1.3 Type of Process or Use U Industrial grade solvent. Used as a metal degreaser.

NAICS 33251 Hardware manufacturing.

IFC U27 Solvents ( for cleaning or degreasing).

Percent PV 20 20% PV ( 4,000,000 lbs) is distributed from distribution/ repackaging centers to 200 hardware manufacturers for use as a metal degreaser.

Number of Sites S4 From 101 to 250. 200 hardware manufacturers use xylene as a metal degreaser.

Number of Workers W6 At least 500 but fewer than 1000. Company B estimates 3 exposed workers for each of 200 sites. 3 workers per site x 200 sites = 600 workers. DRAFT: Appendix G Case Studies Block Block Title Report Basis/ Rationale 1.4 Type of Process or Use PF Incorporation into formulations and mixtures.

NAICS 32551 Paint and coating manufacturing.

IFC U28 Solvents ( which become part of product formulation or mixture).

Percent PV 20 16% PV of xylene ( 3,200,000 lbs.) is used in paint formulations. Round to 20%.

Number of Sites Company G has determined that this information is not readily obtainable.

Number of Workers Company G has determined that this information is not readily obtainable.

1.5 Type of Process or Use PF Incorporation into formulations and mixtures.

NAICS 32111 Sawmills and wood preservation.

IFC U28 Solvents ( which become part of product formulation or mixture).

Percent PV 2 2% PV ( 400,000 lbs.) of xylene is used as a component in wood preservatives. This percentage is rounded to the nearest percentage point because it is less than 5% and volume is 300,000 lbs. or greater.

Number of Sites Company G has determined that this information is not readily obtainable.

Number of Workers Company G has determined that this information is not readily obtainable.

Part III  Section II. Commercial and Consumer End Use Exposure Related Data Block Block Title Report Basis/ Rationale 2.1 Commercial and Consumer Product Category C03 Automotive care products.

Use in Children's Product N Not expected to be used by children.

Percent PV 30 30% PV ( 6,000,000 lbs.) is used in the formulation of automotive care products.

Maximum Concentration M3 From 31% to 60% by weight. The maximum concentration used in formulations is 35%. DRAFT: Appendix G Case Studies Block Block Title Report Basis/ Rationale 2.2 Commercial and Consumer Product Category C12 Paints and coatings ( commercial use).

Use in Children's Product N Not expected to be used by children.

Percent PV 20 16% PV ( 3,200,000 lbs.) is used in paints for commercial use. Round up to 20%.

Maximum Concentration M2 From 1% to 30% by weight. The maximum concentration used in formulations is 15%.

2.3 Commercial and Consumer Product Category C18 Wood and wood furniture.

Use in Children's Product N Not expected to be used by children.

Percent PV 2 2% PV ( 400,000 lbs. ) of xylene is used as a component in wood preservatives. Since this percentage is less than 5% and totals 300,000 pounds or greater, round to the nearest percentage point ( 2%).

Maximum Concentration M2 From 1% to 30% by weight. The maximum concentration used in formulations is 20%. DRAFT: Appendix G Case Studies Form U  CASE STUDY G Page ___ of ___

PART II. MANUFACTURING INFORMATION SECTION I. CHEMICAL IDENTIFICATION CBI*

1.1 Chemical Identifying Number 1330 20 7 1.2 ID Code C 1.3 Chemical Name Xylene, Mixed Isomers SECTION II. MANUFACTURING INFORMATION 2.1 Company Information CBI 2.2 Plant Site Identity* CBI a. Physical Form b. Percent of Production Volume in Each Physical Form Check All That Apply CBI Percent CBI 2.3 Site Limited ( Y/ N) N CBI 2.9 Dry Powder 2.4 Activity ( M, I or both) B CBI 2.10 Pellets or Large Crystals 2.5 Production Volume ( LB) 20,000,000 CBI 2.11 Water or Solvent Wet Solid 2.6 Production Volume Range CBI 2.12 Other Solid 2.7 Number of Workers ( code) W2 CBI 2.13 Gas or Vapor 2.8 Maximum Concentration ( code) M5 CBI 2.14 Liquid

100 PART III. PROCESSING AND USE INFORMATION Complete Part III, Section I and II only if the production volume noted in Part II, Section II, Block 2.5 is greater than or equal to 3,000,000 lb/ year SECTION I. INDUSTRIAL PROCESSING AND USE DATA N/ A a. Type of Process or Use b. ( 5 digit) NAICS c. Industrial Function Category d. % Production Volume e. Number of Sites f. Number of Workers Code CBI Code CBI Code CBI Code CBI Code CBI Code CBI 1.1 PC 32519 U16 20 S1 W2 1.2 PF 32519 U27 80 S2 W4 1.3 U 33251 U27 20 S4 W6 1.4 PF 32551 U28 20 1.5 PF 32111 U28 2 1.6 1.7 1.8 1.9 1.10 SECTION II. COMMERCIAL & CONSUMER END USE EXPOSURE RELATED DATA N/ A a. Commercial and Consumer Product Category b. Use in Children's Product c. Percent Production Volume associated with each category d. Maximum Concentration associated with each category Code CBI Y/ N/? CBI Percent CBI Code CBI 2.1 C03 N 30 M3 2.2 C12 N 20 M2 2.3 C18 N 2 M2 2.4 2.5 2.6 2.7 2.8 2.9 2.10 * Substantiation required for CBI claims on chemical identity and plant site identity. REPORT NUMBER


19203 Federal Register / Vol. 68, No. 75 / Friday, April 18, 2003 / Notices electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

C. What Should I Consider When I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the collection activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

D. What Information Is EPA Particularly Interested in?

Pursuant to section 3506( c)( 2)( A) of the PRA, EPA specifically solicits comments and information to enable it to: 1. Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility. 2. Evaluate the accuracy of the Agency's estimates of the burdens of the proposed collections of information. 3. Enhance the quality, utility, and clarity of the information to be collected. 4. Minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated or electronic collection technologies or other forms of information technology, e. g., permitting electronic submission of responses.

IV. What Information Collection Activity or ICR Does This Action Apply to?

EPA is seeking comments on the following ICR: Title: Compliance Requirement for Child Resistant Packaging. ICR numbers: EPA ICR No. 0616.08, OMB Control No. 2070   0052. ICR status: This ICR is a renewal of an existing ICR that is currently approved by OMB and is due to expire January 31, 2004. Abstract: This information collection program is designed to provide EPA with assurances that the packaging of pesticide products sold and distributed to the general public in the United States meets standards set forth by the Agency pursuant to FIFRA. Registrants must certify to the Agency that the packaging or device meets these standards. Responses to this collection are required in order to obtain pesticide registration. The authority for this information collection is pursuant to section 25 ( c)( 3) of FIFRA. Compliance regulations are contained in title 40 of the Code of Federal Regulations ( CFR) part 157. CBI submitted to EPA in response to this information collection is protected from disclosure under FIFRA section 10.

V. What Are EPA's Burden and Cost Estimates for This ICR?

Under the PRA, `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The ICR provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this ICR is estimated to be 853.4 hours. The following is a summary of the estimates taken From the ICR: Respondents/ affected entities: Pesticide registrants who sell and distribute pesticide products to the general public in the United States. Estimated total number of potential respondents: 502. Frequency of response: Per event. Estimated total/ average number of responses for each respondent: 1. Estimated total annual burden hours: 853.4. Estimated total annual burden costs: $ 58,232.00.

VI. Are There Changes in the Estimates From the Last Approval? Total respondent costs associated with this program rose from $ 55,019.20 to $ 58,232.00. Total Agency costs rose from $ 213,751.60 to $ 245,176.80. Changes to total costs associated with this program are due to the increase in labor rates, reflecting the most current estimates.

VII. What Is the Next Step in the Process for This ICR? EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5( a)( 1)( iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects Environmental protection, Reporting and recordkeeping requirements.

Dated: April 9, 2003. Susan B. Hazen, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances.

[ FR Doc. 03   9485 Filed 4   17   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2003   0017; FRL   7303   3]

Voluntary Cover Sheet for TSCA Submissions; Request for Comment on Renewal of Information Collection Activities AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( PRA), EPA is seeking public comment on the following Information Collection Request ( ICR): Voluntary Cover Sheet for TSCA Submissions, ( EPA ICR No. 1780.03, OMB Control No. 2070   0156). This ICR involves a collection activity that is currently approved and scheduled to expire on February 29, 2004. The use of this information collection will enable the Agency more VerDate Jan< 31> 2003 16: 31 Apr 17, 2003 Jkt 200001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 18APN1. SGM 18APN1 OPPT 2003 0017 0001 RECEIVED OPPT NCIC 2003 APR 18 7: 16AM 19204 Federal Register / Vol. 68, No. 75 / Friday, April 18, 2003 / Notices easily to collect, identify, process, store, retrieve, and disseminate information on health and environmental risks associated with toxic chemicals. Before submitting this ICR to the Office of Management and Budget ( OMB) for review and approval under the PRA, EPA is soliciting comments on specific aspects of the collection. DATES: Written comments, identified by the docket ID number OPPT   2003   0017, must be received on or before June 17, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Director, Environmental Assistance Division ( 7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 554   1404; e mail address: TSCAHotline epa. gov. For technical information contact: Ron Carlson, Information Management Division ( 7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 564   8631; fax number: ( 202) 564   7480; email address: carlson. ron@ epa. gov. SUPPLEMENTARY INFORMATION:

I. General Information A. Does This Action Apply to Me? You may be potentially affected by this action if you manufacture, process, use, import, or distribute in commerce chemical substances that are subject to reporting requirements under sections 4, 8( d), or 8( e) of the Toxic Substances Control Act ( TSCA). Potentially affected entities may include, but are not limited to:   Petroleum and Coal Products Manufacturing ( NAICS 324), e. g., Petroleum Refineries, Petroleum Lubricating Oil and Grease Manufacturing, Asphalt Paving, Roofing and Saturated Materials Manufacturing, and Other Petroleum and Coal Products Manufacturing.   Chemical Manufacturing ( NAICS 325), e. g., Basic Chemical Manufacturing, Synthetic Dye and Pigment Manufacturing, Inorganic Dye and Pigment Manufacturing, Paint and Coating Manufacturing, and Adhesive Manufacturing.   Petroleum and Petroleum Products Wholesalers ( NAICS 42272), e. g., Petroleum and Petroleum Products Wholesalers ( except Bulk Stations and Terminals). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of This Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT   2003   0017. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102 Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is ( 202) 566   1744 and the telephone number for the OPPT Docket, which is located in the EPA Docket Center, is ( 202) 566   0280. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit the Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper VerDate Jan< 31> 2003 16: 31 Apr 17, 2003 Jkt 200001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 18APN1. SGM 18APN1 19205 Federal Register / Vol. 68, No. 75 / Friday, April 18, 2003 / Notices receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPPT   2003   0017. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to oppt. ncic@ epa. gov, Attention: Docket ID Number OPPT   2003   0017. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your email address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Document Control Office ( 7407M), Office of Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. By hand delivery or courier. Deliver your comments to: OPPT Document Control Office ( DCO) in EPA East Building Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT   2003   0017. The DCO is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is ( 202) 564   8930.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider When I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the collection activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

F. What Information Is EPA Particularly Interested in?

Pursuant to section 3506( c)( 2)( A) of the PRA, EPA specifically solicits comments and information to enable it to: 1. Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility. 2. Evaluate the accuracy of the Agency's estimates of the burdens of the proposed collections of information. 3. Enhance the quality, utility, and clarity of the information to be collected. 4. Minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated or electronic collection technologies or other forms of information technology, e. g., permitting electronic submission of responses.

II. What Information Collection Activity or ICR Does This Action Apply to?

EPA is seeking comments on the following ICR: Title: Voluntary Cover Sheet for TSCA Submissions. ICR numbers: EPA ICR No. 1780.03, OMB Control No. 2070   0156. ICR status: This ICR is currently scheduled to expire on February 29, 2004.

VerDate Jan< 31> 2003 16: 31 Apr 17, 2003 Jkt 200001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 18APN1. SGM 18APN1 19206 Federal Register / Vol. 68, No. 75 / Friday, April 18, 2003 / Notices An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that is subject to approval under PRA, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. Abstract: TSCA requires industry to submit information and studies for existing chemical substances under sections 4, 6, and 8. Under normal reporting conditions, EPA receives thousands of submissions each year; each submission represents on average three studies. In addition, specific data call ins can be imposed on industry. As a follow up to industry experience with a 1994 TSCA data call in, the Chemical Manufacturers Association ( CMA, now known as the American Chemistry Council ( ACC)), the Specialty Organics Chemical Manufacturers Association ( SOCMA), and the Chemical Industry Data Exchange ( CIDX), in cooperation with EPA, took an interest in pursuing electronic transfer of TSCA summary data and of full submissions to EPA. In particular, ACC developed a standardized cover sheet for voluntary use by industry as a first step to an electronic future and to begin familiarizing companies with standard requirements and concepts of electronic transfer. This form is designed for voluntary use as a cover sheet for submissions of information under TSCA sections 4, 8( d), and 8( e). The cover sheet facilitates submission of information by displaying certain basic data elements, permitting EPA more easily to identify, log, track, distribute, review and index submissions, and to make information publicly available more rapidly and at reduced cost, to the mutual benefit of both the respondents and EPA. Responses to the collection of information are voluntary. Respondents may claim all or part of a notice CBI. EPA will disclose information that is covered by a CBI claim only to the extent permitted by, and in accordance with, the procedures in 40 CFR part 2.

III. What Are EPA's Burden and Cost Estimates for This ICR? Under the PRA, `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The ICR provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this collection of information is estimated to average 0.5 hours per response. The following is a summary of the estimates taken from the ICR: Respondents/ affected entities: 964. Estimated total number of potential respondents: Unknown. Frequency of response: On occasion. Estimated average number of responses for each respondent: 19. Estimated total annual burden hours: 9,136 hours. Estimated total annual burden costs: $ 703,435.

IV. Are There Changes in the Estimates From the Last Approval?

There is an increase of 8,221 hours ( from 915 hours to 9,136 hours) in the total estimated respondent burden compared with that identified in the information collection request most recently approved by OMB. This change reflects a net increase in the estimated number of submissions under TSCA sections 4, 8( d), and 8( e) for which the Voluntary TSCA Cover Sheet could be used, in particular a substantial increase in the estimated number of TSCA section 4 submissions. Since the use of the Voluntary TSCA Cover Sheet is a direct reflection of the number of submissions received under TSCA sections 4, 8( d), and 8( e), any change in the estimated numbers of submissions under those requirements will result in a parallel change in the burden hours associated with this information collection. This increase represents an adjustment.

V. What Is the Next Step in the Process for This ICR?

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5( a)( 1)( iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects Environmental protection, Reporting and recordkeeping requirements.

Dated: April 9, 2003. Susan B. Hazen, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances.

[ FR Doc. 03   9624 Filed 4   17   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ ER   FRL   6639   4]

Environmental Impact Statements; Notice of Availability Responsible Agency: Office of Federal Activities, General Information ( 202) 564   7167 or http:// epa. gov/ complianc/ nepa/. Weekly receipt of Environmental Impact Statements filed April 7, 2003, through April 11, 2003, pursuant to 40 CFR 1506.9. EIS No. 030163, Draft EIS, SFW, CA, Programmatic EIS   San Francisco Estuary Invasive Spartina Project, Spartina Control Program to Preserve and Restore Ecological Integrity of the Estuary's Intertidal Habitats, Alameda, Contra Costa, Marin, Napa, San Francisco, San Mateo, CA, comment period ends: June 2, 2003, contact: Mark Littlefield ( 916) 414   6581. This document is available on the Internet at: http:// sacramento. fws. gov. EIS No. 030164, Final Supplement, COE, FL, PCS Phosphate   White Springs Mine Continuation Mining Operations, Proposes to Discharge Dredged/ Fill Material into 1,858 Acres of Jurisdictional Wetlands, Applications of `` Life of Mine'' Permits, Hamilton County, FL, wait period ends: May 19, 2003, contact: Richard Legere ( 352) 331   0732. EIS No. 030165, Final EIS, COE, ND, Devils Lake Basin North Dakota Study, the Reduction of Flood Damages Related to the Rising Lake Levels and the Flood Prone Areas Around Devils Lake and to Reduce the Potential for Natural Overflow Event, Sheyenne River and Red River of the North, ND, wait period ends:

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