GDCI Forms A-C

GDCI forms A-C_example.pdf

Pesticides Data Call In Program

GDCI Forms A-C

OMB: 2070-0174

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Page 1

United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE

OMB Approval 2070-0174
EPA FORM 6300-4

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address

3. Date and Type of DCI and Number

2. Case # and Name
3080 - Iodine
Chemical # and Name: 046905
Iodine

4. EPA Product
Registration

5. I wish to cancel
this product
registration
voluntarily

6. Generic Data
6a. I am claiming a Generic Data
Exemption because I obtain the
active ingredient from the source
EPA registration number listed
below.

18-Jan-2017
GENERIC
ID # GDCI-046905-1444

7. Product Specific Data
6b. I agree to satisfy Generic Data
Requirements as indicated on the
attached form entitled
"Requirements Status and
Registrant's Response."

7a. My product is an MUP and I
agree to satisfy the MUP
requirement on the attached form
entitled "Requirements Status and
Registrant's Response."

8. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
Initial to indicate certification as to information on this page
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
(full text of certification is on page one).
Signature and Title of Company's Authorized Representative ______________________________________________________
10. Name of Company

Date

7b. My product is an EUP and I
agree to satisfy the EUP
requirement on the attached form
entitled "Requirements Status and
Registrant's Response."

9. Date

11. Phone Number

Page

United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

1 of

OMB Approval 2070-0174
EPA FORM 6300-3

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.
1. Company Name and Address

4. Guideline
Requirement
Number

2. Case # and Name

3. Date and Type of DCI and Number

3080 - Iodine
Chemical # and Name: 046905
Iodine

18-Jan-2017
GENERIC
ID # GDCI-046905-1444

P
R
O
T
O
C
O
L

5. Study Title

Progress
Reports

6. Use
Pattern

7. Test
Substance

8. Time
Frame
(Months)

Applicator Exposure Data Requirements (Conventional
Chemical)
875.1400

Inhalation exposure--indoor

(3, 5, 20)

Z,U,V,Y,R,S,T,W,X

TGAI

Nontarget Plant Protection Data Requirements (Conventional
Chemical)
850.4225

Seedling emergence, Tier II

(6, 9, 17, 18,
21)

Z,U,V,Y,R,S,T,W,X

TEP

850.4400

Aquatic Plant Toxicity Using Lemna spp

(6, 9, 16, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

(5, 19, 23,
24)

Z,U,V,Y,R,S,T,W,X

TGAI

(4, 9, 21)

Z,U,V,Y,R,S,T,W,X

TEP

Post-Application Exposure Data Requirements (Conventional
Chemical)
875.2300

Indoor surface residue dissipation
Terrestrial and Aquatic Nontarget Organisms Data
Requirements (Conventional Chemical)

850.1010

Aquatic invertebrate acute toxicity, test, freshwater
daphnids

10. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

11. Date

Signature and Title of Company's Authorized Representative _________________________________________________________________
Initial to indicate certification as to information on this page (full text of certification is on page one)
12. Name of Company

13. Phone Number

9. Registrant
Response

Page

United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

2 of

OMB Approval 2070-0174
EPA FORM 6300-3

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.
1. Company Name and Address

4. Guideline
Requirement
Number

2. Case # and Name

3. Date and Type of DCI and Number

3080 - Iodine
Chemical # and Name: 046905
Iodine

18-Jan-2017
GENERIC
ID # GDCI-046905-1444

P
R
O
T
O
C
O
L

5. Study Title

Progress
Reports

6. Use
Pattern

7. Test
Substance

8. Time
Frame
(Months)

Terrestrial and Aquatic Nontarget Organisms Data
Requirements (Conventional Chemical)
(1, 6, 9, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

(6, 9, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

(2, 6, 9, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

Fish acute toxicity test, freshwater and marine

(4, 9, 21)

Z,U,V,Y,R,S,T,W,X

TEP

850.1300

Daphnid chronic toxicity test

(6, 9, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

850.1400

Fish early-life stage toxicity test

(6, 9, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

(3, 5, 22, 24)

Z,U,V,Y,R,S,T,W,X

TGAI

850.1025

Oyster acute toxicity test (shell deposition)

850.1035

Mysid acute toxicity test

850.1055

Bivalve acute toxicity test (embryo larval)

850.1075

Toxicology Data Requirements (Conventional Chemical)
870.3465

90-day inhalation toxicity

9. Registrant
Response

Page

United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

3 of

OMB Approval 2070-0174
EPA FORM 6300-3

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.
1. Company Name and Address

4. Guideline
Requirement
Number

2. Case # and Name

3. Date and Type of DCI and Number

3080 - Iodine
Chemical # and Name: 046905
Iodine

18-Jan-2017
GENERIC
ID # GDCI-046905-1444

P
R
O
T
O
C
O
L

5. Study Title

Progress
Reports

6. Use
Pattern

7. Test
Substance

8. Time
Frame
(Months)

835.3110

Ready biodegradability

(4, 15, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

835.3220

Porous pot test

(4, 14, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

835.3240

Simulation Test-Aerobic Sewage Treatment-Activated
Sludge

(4, 13, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

835.3280

Simulation Tests to Assess the Biodegradability of
Chemicals

(4, 12, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

850.3300

Modified Activated Sludge, Respiration Inhibition Test

(4, 9, 11, 21)

Z,U,V,Y,R,S,T,W,X

TGAI

850.4500

Algal Toxicity

(6, 8, 9, 10,
21)

Z,U,V,Y,R,S,T,W,X

TGAI

850.4550

Cyanobacteria (Anabaena flos-aquae) Toxicity

(6, 8, 9, 10,
21)

Z,U,V,Y,R,S,T,W,X

TGAI

SS-1240

Leaching Study: Paint, Stain, And Coatings

(7, 9, 24)

Z,U,V,Y,R,S,T,W,X

TGAI

Date

9. Registrant
Response

Page:

United States Environmental Protection Agency
Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name:
DCI Number:

3080 - Iodine
GDCI-046905-1444

Key: [Degr] = Degradate; [d-EP] = diluted End-use product; [EP] = End-use product; [MET] = Plant metabolite; [MP] = Manufacturing-use product; [PAI] = Pure Active Ingredient; [PAIRA] =
Pure active ingredient radio-labelled; [RAMET] = Radio-labeled plant metabolite; [ROC] = Residue of Concern; [TEP] = Typical end-use product; [TGAI] = Technical grade of the active
ingredient; [TW] = Treated wood
Use Categories Key:
R - Agricultural premises and equipment
S - Food handling/storage establishments premises
and equipment
T - Commercial, institutional and industrial premises
and equipment
U - Residential and public access premises
V - Medical premises and equipment
W - Human drinking water systems
X - Materials preservatives
Y - Industrial processes and water systems once through
Z - Industrial processes and water systems - not
once through
Footnotes: The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form.
These footnotes apply in addition to any test notes included in 40 CFR Part 158 with respect to the particular data requirement.
1

This study can be substituted for GLN 850.1055, Bivalve embryo larval toxicity test.

This study can be subsituted for GLN 850.1025, Oyster shell deposition.

The inhalation exposure scenarios include open pouring of liquids and wettable powder for material preservation, low pressure hand wand, high pressure handwand, trigger sprayer, mop and
wipe application, and airless sprayer application of preserved paints.

Testing must be completed with the iodophors.

Testing must be completed with iodine.

Testing must be completed with both iodine and the iodophors.

Test substance is TGAI: polystyrene divinyl benzene quaternary ammonium
anion exchange resiniodine complex.

One Tier II (dose response) study, conducted with Selenastrum capricornutum, is required if the results of this study exhibit detrimental effects (EC50 less than 1.0 ppm or mg/L), then additional
Tier II (dose response) studies will be required on three species (Anabaena flos-aquae, Navicula pelliculosa, and Skeletonema costatum).

Iodophor molecule data are needed if there is a likelihood for exposure to the carrier in aquatic systems. The agency has limited data on the carrier portion of these molecules. If it can be shown
that there is no aquatic exposure, ecotoxicity data will not be necessary for the iodophors.

Page:

United States Environmental Protection Agency
Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name:
DCI Number:

3080 - Iodine
GDCI-046905-1444

In a Federal Register Notice dated June 27, 2012, EPA split the Public Draft OPPTS 850.5400 test guideline into two test guidelines: OCSPP 850.4500 and OCSPP 850.4550. See "Final Test
Guidelines; OCSPP 850 Series; Notice of Availability" 77 FR 38282, June 27, 2012. https://www.regulations.gov/document?D=EPA-HQ-OPPT-2009-0154-0028.

EPA published draft guidance under guideline 850.6800 and has since published final guidance for this study under guideline 850.3300: http://www.regulations.gov/#!documentDetail;D=EPA-HQOPPT-2009-0154-0021.
OECD Test Guideline 209 can also be used as guidance for this study, available online at http://www.oecd-ilibrary.org/content/book/9789264070080-en. The results of the Activated Sludge
Respiration Inhibition Test (ASRI), GLN 850.3300, will determine which of the four biodegradation tests is/are required. If the ASRI test EC50 is less than or equal to 20 mg/L, then either the (i)
Biodegradation in Activated Sludge Study, GLN 835.3280 or (ii) Simulation Test - Aerobic Sewage Treatment: A. Activated Sludge Units, GLN 835.3240, or (iii) the Porous Pot Test, GLN 835.3220
is required. If the ASRI test EC50 is greater than 20 mg/L, then the registrant must conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge, or b) Simulation Test Aerobic Sewage Treatment: A. Activated Sludge Units, or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing is required. If, however,
the antimicrobial fails the Ready Biodegradability study, then the (i) Biodegradation in Activated Sludge, or (ii) Simulation Test - Aerobic Sewage Treatment: A. Activated Sludge Units, or (iii) the
Porous Pot study is required.

EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0036. The biodegradation study required is based on results of an
Activated Sludge Respiration Inhibition test.

EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0034. The biodegradation study required is based on results of an
Activated Sludge Respiration Inhibition test.

EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0024. The biodegradation study required is based on results of an
Activated Sludge Respiration Inhibition test.

EPA has a published final guideline for this study: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0017. The biodegradation study required is based on results of an
Activated Sludge Respiration Inhibition test.

Data is required if the aquatic (algal) plant growth Tier II study with Selenastrum capricornutum demonstrates detrimental effects at less than 1.0 ppm (mg/L).

Data are required only if the risk quotient from any aquatic plant growth Tier II test exceeds a level of concern for aquatic plants.

Data are required on rice. Data re not required on other species of terrestrial plants.

Data are required for the following use: household floor sanitizers.

Data are required for all use patterns which have the potential to result in human inhalation exposures.

Data are required for all use patterns which have the potential to result in contamination of surface water.

An inhalation absorption study is required for all use patterns which have the potential to result in human inhalation exposures.

A waiver may be requested for all applications if a residue screening level default at 100% of the application rate does not trigger risk concerns.

A protocol must be approved by the Agency prior to the initiation of the study.

Page:

OMB Approval 2070-0174

United States Environmental Protection Agency
Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name:
DCI Number:
Co. Nr.

Company Name

875

DIVERSEY, INC.

39444

KATADYN PRODUKTE

4959

Agent For Company

3080 - Iodine
GDCI-046905-1444

Address

City

State

ZIP

8310 16TH STREET, MS 707

STURTEVANT

53177

8203 WEST 20TH STREET, SUITE A

GREELEY

806344696

WEST AGRO INC

11100 N. CONGRESS AVE.

KANSAS CITY

64153

46183

SAFEWAY INDUSTRIES, INC.

840 WALWORTH STREET

WALWORTH

531849515

91282

CLARION WATER, LLC

3530 W. GARRY AVENUE

SANTA ANA

92704

8405

WEBCO CHEMICAL CORP

420 WEST MAIN ST

DUDLEY

01571

66171

PRESERVE INTERNATIONAL

P.O. Box 17003

RENO

89511

1677

ECOLAB, INC.

370 NORTH WABASHA STREET

ST. PAUL

55102

59454

PUROLITE CO, THE

12510 PROSPERITY DRIVE, SUITE 160

SILVER SPRING

20904

84890

PURELABS, LLC

P.O. Box 8050

MADISON

53708

74473

WATER SECURITY CORPORATION

1455 KLEPPE LANE

SPARKS

89431

35917

HYBRID TECHNOLOGIES CORPORATION

8203 WEST 20TH STREET, SUITE A

GREELEY

806344696

50233

POLAR EQUIPMENT INC

12881 FOOTHILL LANE

SARATOGA

95070

74245

MRLB INTERNATIONAL, INC.

2450 COLLEGE WAY

FERGUS FALLS

56537

84020

PROEDGE DENTAL PRODUCTS

201 W. VAN BUREN STREET

COLUMBIA CITY

46725

LEWIS & HARRISON, LLC

DELTA ANALYTICAL CORP

REGWEST COMPANY, LLC

SRC SCIENTIFIC & REGULATORY
CONSULTANTS, INC

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File Modified	2018-06-28
File Created	2017-01-18