Initial to indicate certification as to information on this page

(full text of certification is on page one).

Date

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.

2. Case # and Name 3. Date and Type of DCI and Number

4. EPA Product 

Registration

5. I wish to cancel 

this product 

registration 

voluntarily

6. Generic Data 7. Product Specific Data

6a. I am claiming a Generic Data 

Exemption because I obtain the 

active ingredient from the source 

EPA registration number listed 

below.

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."

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."

OMB Approval 2070-0174

EPA FORM 6300-4

1. Company Name and Address

NUFARM LIMITED

4020 AERIAL CENTER PKWY., STE 101

MORRISVILLE, NC 27560 

N/A - Myclobutanil

Chemical # and Name: 128857

Myclobutanil

14-Apr-2016

GENERIC

ID # GDCI-128857-1536

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page 1 of 1

35935-99

8. 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.

Signature and Title of Company's Authorized Representative ______________________________________________________

10. Name of Company

N/A N/A

9. Date

11. Phone Number 
Initial to indicate certification as to information on this page

(full text of certification is on page one).

Date

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.

2. Case # and Name 3. Date and Type of DCI and Number

4. EPA Product 

Registration

5. I wish to cancel 

this product 

registration 

voluntarily

6. Generic Data 7. Product Specific Data

6a. I am claiming a Generic Data 

Exemption because I obtain the 

active ingredient from the source 

EPA registration number listed 

below.

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."

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."

OMB Approval 2070-0174

EPA FORM 6300-4

1. Company Name and Address

ALBAUGH, LLC

P.O. Box 2127

VALDOSTA, GA 316042127

N/A - Myclobutanil

Chemical # and Name: 128857

Myclobutanil

14-Apr-2016

GENERIC

ID # GDCI-128857-1536

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page 1 of 1

42750-142

8. 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.

Signature and Title of Company's Authorized Representative ______________________________________________________

10. Name of Company

N/A N/A

9. Date

11. Phone Number 
Initial to indicate certification as to information on this page

(full text of certification is on page one).

Date

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.

2. Case # and Name 3. Date and Type of DCI and Number

4. EPA Product 

Registration

5. I wish to cancel 

this product 

registration 

voluntarily

6. Generic Data 7. Product Specific Data

6a. I am claiming a Generic Data 

Exemption because I obtain the 

active ingredient from the source 

EPA registration number listed 

below.

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."

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."

OMB Approval 2070-0174

EPA FORM 6300-4

1. Company Name and Address

DOW AGROSCIENCES LLC

9330 ZIONSVILLE RD 308/2E

INDIANAPOLIS, IN 462681054

N/A - Myclobutanil

Chemical # and Name: 128857

Myclobutanil

14-Apr-2016

GENERIC

ID # GDCI-128857-1536

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page 1 of 1

62719-407

8. 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.

Signature and Title of Company's Authorized Representative ______________________________________________________

10. Name of Company

N/A N/A

9. Date

11. Phone Number 
Initial to indicate certification as to information on this page (full text of certification is on page one) 

13. Phone Number

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.

12. Name of Company

11. Date

OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

Signature and Title of Company's Authorized Representative _________________________________________________________________

NUFARM LIMITED

4020 AERIAL CENTER PKWY., STE 101

MORRISVILLE, NC 27560 

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

850.4100

850.4150

850.4400

850.1075

850.2100

850.3040

850.4500

Seedling Emergence and Seedling Growth

Vegetative Vigor

Aquatic Plant Toxicity Using Lemna spp

Fish acute toxicity test, freshwater and marine

Avian acute oral toxicity test

Field testing for pollinators

Algal Toxicity

N/A - Myclobutanil

Chemical # and Name: 128857

Myclobutanil

14-Apr-2016

GENERIC

ID # GDCI-128857-1536

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

TEP

TEP

TEP

TGAI

TGAI

TEP

TEP

12

12

12

12

12

24

12

Page 1 of 

(3, 6, 14)

(7)

N

N

N

N

N

Y

N

2
OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

NUFARM LIMITED

4020 AERIAL CENTER PKWY., STE 101

MORRISVILLE, NC 27560 

850.4550

SS-1113

SS-1311

SS-1312

SS-1313

SS-1314

SS-1315

Cyanobacteria (Anabaena flos-aquae) Toxicity

Residue Analysis of Nectar and Pollen in Flowering 

Crops

Honey bee adult acute oral toxicity

Honey bee larvae acute oral toxicity

Honey bee adult chronic oral toxicity

Honey bee larvae chronic oral toxicity

Semi-field testing for pollinators 

N/A - Myclobutanil

Chemical # and Name: 128857

Myclobutanil

14-Apr-2016

GENERIC

ID # GDCI-128857-1536

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

TEP

TEP

TGAI

TGAI

TGAI

TGAI

TEP

12

24

12

12

12

12

24

Page 2 of 

(7)

(1, 4, 14)

(5)

(10)

(8)

(9, 11, 14)

(2, 12, 13, 

14)

N

Y

N

N

N

Y

Y

2
13. Phone Number

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.

12. Name of Company

11. Date

OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

Signature and Title of Company's Authorized Representative _________________________________________________________________

ALBAUGH, LLC

P.O. Box 2127

VALDOSTA, GA 316042127

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

850.4100

850.4150

850.4400

850.1075

850.2100

850.3040

850.4500

Seedling Emergence and Seedling Growth

Vegetative Vigor

Aquatic Plant Toxicity Using Lemna spp

Fish acute toxicity test, freshwater and marine

Avian acute oral toxicity test

Field testing for pollinators

Algal Toxicity

N/A - Myclobutanil

Chemical # and Name: 128857

Myclobutanil

14-Apr-2016

GENERIC

ID # GDCI-128857-1536

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

TEP

TEP

TEP

TGAI

TGAI

TEP

TEP

12

12

12

12

12

24

12

Page 1 of 

(3, 6, 14)

(7)

N

N

N

N

N

Y

N

2
OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

ALBAUGH, LLC

P.O. Box 2127

VALDOSTA, GA 316042127

850.4550

SS-1113

SS-1311

SS-1312

SS-1313

SS-1314

SS-1315

Cyanobacteria (Anabaena flos-aquae) Toxicity

Residue Analysis of Nectar and Pollen in Flowering 

Crops

Honey bee adult acute oral toxicity

Honey bee larvae acute oral toxicity

Honey bee adult chronic oral toxicity

Honey bee larvae chronic oral toxicity

Semi-field testing for pollinators 

N/A - Myclobutanil

Chemical # and Name: 128857

Myclobutanil

14-Apr-2016

GENERIC

ID # GDCI-128857-1536

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

TEP

TEP

TGAI

TGAI

TGAI

TGAI

TEP

12

24

12

12

12

12

24

Page 2 of 

(7)

(1, 4, 14)

(5)

(10)

(8)

(9, 11, 14)

(2, 12, 13, 

14)

N

Y

N

N

N

Y

Y

2
13. Phone Number

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.

12. Name of Company

11. Date

OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

Signature and Title of Company's Authorized Representative _________________________________________________________________

DOW AGROSCIENCES LLC

9330 ZIONSVILLE RD 308/2E

INDIANAPOLIS, IN 462681054

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

850.4100

850.4150

850.4400

850.1075

850.2100

850.3040

850.4500

Seedling Emergence and Seedling Growth

Vegetative Vigor

Aquatic Plant Toxicity Using Lemna spp

Fish acute toxicity test, freshwater and marine

Avian acute oral toxicity test

Field testing for pollinators

Algal Toxicity

N/A - Myclobutanil

Chemical # and Name: 128857

Myclobutanil

14-Apr-2016

GENERIC

ID # GDCI-128857-1536

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

TEP

TEP

TEP

TGAI

TGAI

TEP

TEP

12

12

12

12

12

24

12

Page 1 of 

(3, 6, 14)

(7)

N

N

N

N

N

Y

N

2
Date

OMB Approval 2070-0174 

EPA FORM 6300-3

United States Environmental Protection Agency 

Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE

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.

4. Guideline

Requirement

Number

5. Study Title Progress 

Reports

1 2 3

6. Use 

Pattern

7. Test 

Substance

8. Time

Frame 

(Months)

9. Registrant

Response

P

R

O

T

O

C

O

L

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number

DOW AGROSCIENCES LLC

9330 ZIONSVILLE RD 308/2E

INDIANAPOLIS, IN 462681054

850.4550

SS-1113

SS-1311

SS-1312

SS-1313

SS-1314

SS-1315

Cyanobacteria (Anabaena flos-aquae) Toxicity

Residue Analysis of Nectar and Pollen in Flowering 

Crops

Honey bee adult acute oral toxicity

Honey bee larvae acute oral toxicity

Honey bee adult chronic oral toxicity

Honey bee larvae chronic oral toxicity

Semi-field testing for pollinators 

N/A - Myclobutanil

Chemical # and Name: 128857

Myclobutanil

14-Apr-2016

GENERIC

ID # GDCI-128857-1536

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

J,I,C,Q,B,A

TEP

TEP

TGAI

TGAI

TGAI

TGAI

TEP

12

24

12

12

12

12

24

Page 2 of 

(7)

(1, 4, 14)

(5)

(10)

(8)

(9, 11, 14)

(2, 12, 13, 

14)

N

Y

N

N

N

Y

Y

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Myclobutanil

GDCI-128857-1536

1

2

3

4

5

6

7

8

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

The need for measures of residues in pollen/nectar will be determined based upon lower tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment.

The need for a semi-field test for pollinators (i.e., either a field-feeding test or a tunnel test) will be determined based upon the results of lower-tiered tests and/or other lines of evidence, and the

need for a refined pollinator risk assessment.

The need for a field test for pollinators will be determined based upon lower-tiered tests and/or other lines of data and the need for a refined pollinator risk assessment.

The following elements should be considered when developing study protocol(s) for the monitoring of residues in pollen/nectar. (1) Consideration of the range of application methods and 

environmental conditions (e.g., soil and hydric regimes) that the target crop(s) may be under. (2) Consideration of the attractiveness of the selected crop to pollinators (3) Consideration of a 

collection schedule sufficient to allow for an understanding of the character of residues, in the pollen/nectar and/or plant tissues, over time. (4) Consideration of data sufficient to determine 

whether residues of the active ingredient and/or degradation product(s) accumulates in soil and is/are bioavailable for plant to uptake in a following planting, and therefore result in potential 

exposure to pollinators. (5) Consideration of the market proportion of the selected target crop(s).

See the OECD 213: OECD Guidelines for the Testing of Chemicals. Honeybees, Acute Oral Toxicity Test. 213. http://www.oecd-ilibrary.org/environment/test-no-213-honeybees-acute-oraltoxicity-test_9789264070165-en

See information and guidance identified in the EPA documents, (i) USEPA. 2012. White Paper in Support of the Proposed Risk Assessment Process for Bees. Submitted to the FIFRA Scientific 

Advisory Panel for Review and Comment September 11 - 14, 2012. Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs Environmental Fate and Effects Division, 

Environmentally Protection Agency, Washington, DC; Environmental Assessment Directorate, Pest Management Regulatory Agency, California Department of Pesticide Regulation. June 19, 2014. 

http://www2.epa.gov/sites/production/files/2014-06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf and USEPA. 2012c. "Field Testing for Pollinators." Ecological Effects Test 

Guidance OCSPP 850.3030. EPA 712-C-017. Web. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0018.

Results for studies conducted for (i) the freshwater green alga, Selenastrum capricornutum, (ii) the freshwater diatom, Navicula pelliculosa, (iii) the marine diatom, Skeletonema costatum, and 

(iv) the cyanobacteria species Anabaena flos-aquae, must be submitted to satisfy this requirement. Final 850 guidelines for the algal testing were posted in June 2012. The Public Draft OPPTS 

850.5400 Algal Toxicity guideline was split into two separate guidelines and renumbered with the cyanobacteria species separated into OCSPP 850.4550 and the other three species under 

OCSPP 850.4500.

OECD has not yet finalized test guidelines for chronic studies, and efforts are underway to develop standardized guidelines for assessing the effects from chronic exposure to adult and larvae 

in the laboratory. Discussion of the study design elements for the 10-day adult toxicity test can be found in Appendix O of the European Food Safety Authority (EFSA) guidance document: 

EFSA. Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees. EFSA Jounral 2013; 11(7):3295, 266 pp. doi: 

Case # and Name:

DCI Number:

Page: 1 of

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.

Use Categories Key:

A - Terrestrial food crop

B - Terrestrial feed crop

C - Terrestrial nonfood crop

I - Greenhouse nonfood crop

J - Forestry use

Q - Residential outdoor use

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Myclobutanil

GDCI-128857-1536

9

10

11

12

13

14

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

10.2903/j.efsa.2013.3295.

OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft guidance is being developed, see OECD Draft Guidance Document Honey Bee (Apis mellifera) 

Larval Toxicity Test, Repeated Exposure, http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.pdf

OECD Test Guideline 237 may be used to develop a protocol for this study (OECD. 2013 Guidelines for Testing Chemicals. Honey bee (Apis mellifera) larval toxicity test, single exposure.) See: 

http://www.oecd-ilibrary.org/environment/test-no-237-honey-bee-apis-mellifera-larval-toxicity-test-single-exposure_9789264203723-en.

In some cases, information pertaining to acute toxicity to honey bee larvae may be obtained with the chronic honey bee larvae test thereby negating the need for separate acute and chronic 

larval toxicity tests.

Formal guidelines for semi-field tests do not yet exist; however, information that can help guide the development of either a semi-field tunnel test protocol can be found at OECD 75, see: OECD. 

2007. Series on Testing and Assessment Number 75. Guidance document on the honey bee (Apis mellifera L.) brood test under semi-field conditions. Environmental Directorate Joint Meeting of 

the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. ENV/JM/MONO(2007)22. August 31, 2007. 

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2007)22&doclanguage=en.

For field-feeding studies see the following: Oomen et al. 1992: Oomen, P. A. A. DeRuijter and J. Van der Steen. 1992. Method for honey bee brood feeding tests with insect growth-regulating 

insecticides. Bul OEPP/EPPO Bulletin 22: 613-616.

A study protocol must be submitted to, and reviewed by EPA, prior to study initiation.

Case # and Name:

DCI Number:

Page: 2 of 2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Myclobutanil

GDCI-128857-1536

1

2

3

4

5

6

7

8

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

The need for measures of residues in pollen/nectar will be determined based upon lower tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment.

The need for a semi-field test for pollinators (i.e., either a field-feeding test or a tunnel test) will be determined based upon the results of lower-tiered tests and/or other lines of evidence, and the

need for a refined pollinator risk assessment.

The need for a field test for pollinators will be determined based upon lower-tiered tests and/or other lines of data and the need for a refined pollinator risk assessment.

The following elements should be considered when developing study protocol(s) for the monitoring of residues in pollen/nectar. (1) Consideration of the range of application methods and 

environmental conditions (e.g., soil and hydric regimes) that the target crop(s) may be under. (2) Consideration of the attractiveness of the selected crop to pollinators (3) Consideration of a 

collection schedule sufficient to allow for an understanding of the character of residues, in the pollen/nectar and/or plant tissues, over time. (4) Consideration of data sufficient to determine 

whether residues of the active ingredient and/or degradation product(s) accumulates in soil and is/are bioavailable for plant to uptake in a following planting, and therefore result in potential 

exposure to pollinators. (5) Consideration of the market proportion of the selected target crop(s).

See the OECD 213: OECD Guidelines for the Testing of Chemicals. Honeybees, Acute Oral Toxicity Test. 213. http://www.oecd-ilibrary.org/environment/test-no-213-honeybees-acute-oraltoxicity-test_9789264070165-en

See information and guidance identified in the EPA documents, (i) USEPA. 2012. White Paper in Support of the Proposed Risk Assessment Process for Bees. Submitted to the FIFRA Scientific 

Advisory Panel for Review and Comment September 11 - 14, 2012. Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs Environmental Fate and Effects Division, 

Environmentally Protection Agency, Washington, DC; Environmental Assessment Directorate, Pest Management Regulatory Agency, California Department of Pesticide Regulation. June 19, 2014. 

http://www2.epa.gov/sites/production/files/2014-06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf and USEPA. 2012c. "Field Testing for Pollinators." Ecological Effects Test 

Guidance OCSPP 850.3030. EPA 712-C-017. Web. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0018.

Results for studies conducted for (i) the freshwater green alga, Selenastrum capricornutum, (ii) the freshwater diatom, Navicula pelliculosa, (iii) the marine diatom, Skeletonema costatum, and 

(iv) the cyanobacteria species Anabaena flos-aquae, must be submitted to satisfy this requirement. Final 850 guidelines for the algal testing were posted in June 2012. The Public Draft OPPTS 

850.5400 Algal Toxicity guideline was split into two separate guidelines and renumbered with the cyanobacteria species separated into OCSPP 850.4550 and the other three species under 

OCSPP 850.4500.

OECD has not yet finalized test guidelines for chronic studies, and efforts are underway to develop standardized guidelines for assessing the effects from chronic exposure to adult and larvae 

in the laboratory. Discussion of the study design elements for the 10-day adult toxicity test can be found in Appendix O of the European Food Safety Authority (EFSA) guidance document: 

EFSA. Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees. EFSA Jounral 2013; 11(7):3295, 266 pp. doi: 

Case # and Name:

DCI Number:

Page: 1 of

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.

Use Categories Key:

A - Terrestrial food crop

B - Terrestrial feed crop

C - Terrestrial nonfood crop

I - Greenhouse nonfood crop

J - Forestry use

Q - Residential outdoor use

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Myclobutanil

GDCI-128857-1536

9

10

11

12

13

14

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

10.2903/j.efsa.2013.3295.

OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft guidance is being developed, see OECD Draft Guidance Document Honey Bee (Apis mellifera) 

Larval Toxicity Test, Repeated Exposure, http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.pdf

OECD Test Guideline 237 may be used to develop a protocol for this study (OECD. 2013 Guidelines for Testing Chemicals. Honey bee (Apis mellifera) larval toxicity test, single exposure.) See: 

http://www.oecd-ilibrary.org/environment/test-no-237-honey-bee-apis-mellifera-larval-toxicity-test-single-exposure_9789264203723-en.

In some cases, information pertaining to acute toxicity to honey bee larvae may be obtained with the chronic honey bee larvae test thereby negating the need for separate acute and chronic 

larval toxicity tests.

Formal guidelines for semi-field tests do not yet exist; however, information that can help guide the development of either a semi-field tunnel test protocol can be found at OECD 75, see: OECD. 

2007. Series on Testing and Assessment Number 75. Guidance document on the honey bee (Apis mellifera L.) brood test under semi-field conditions. Environmental Directorate Joint Meeting of 

the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. ENV/JM/MONO(2007)22. August 31, 2007. 

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2007)22&doclanguage=en.

For field-feeding studies see the following: Oomen et al. 1992: Oomen, P. A. A. DeRuijter and J. Van der Steen. 1992. Method for honey bee brood feeding tests with insect growth-regulating 

insecticides. Bul OEPP/EPPO Bulletin 22: 613-616.

A study protocol must be submitted to, and reviewed by EPA, prior to study initiation.

Case # and Name:

DCI Number:

Page: 2 of 2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Myclobutanil

GDCI-128857-1536

1

2

3

4

5

6

7

8

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

The need for measures of residues in pollen/nectar will be determined based upon lower tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment.

The need for a semi-field test for pollinators (i.e., either a field-feeding test or a tunnel test) will be determined based upon the results of lower-tiered tests and/or other lines of evidence, and the

need for a refined pollinator risk assessment.

The need for a field test for pollinators will be determined based upon lower-tiered tests and/or other lines of data and the need for a refined pollinator risk assessment.

The following elements should be considered when developing study protocol(s) for the monitoring of residues in pollen/nectar. (1) Consideration of the range of application methods and 

environmental conditions (e.g., soil and hydric regimes) that the target crop(s) may be under. (2) Consideration of the attractiveness of the selected crop to pollinators (3) Consideration of a 

collection schedule sufficient to allow for an understanding of the character of residues, in the pollen/nectar and/or plant tissues, over time. (4) Consideration of data sufficient to determine 

whether residues of the active ingredient and/or degradation product(s) accumulates in soil and is/are bioavailable for plant to uptake in a following planting, and therefore result in potential 

exposure to pollinators. (5) Consideration of the market proportion of the selected target crop(s).

See the OECD 213: OECD Guidelines for the Testing of Chemicals. Honeybees, Acute Oral Toxicity Test. 213. http://www.oecd-ilibrary.org/environment/test-no-213-honeybees-acute-oraltoxicity-test_9789264070165-en

See information and guidance identified in the EPA documents, (i) USEPA. 2012. White Paper in Support of the Proposed Risk Assessment Process for Bees. Submitted to the FIFRA Scientific 

Advisory Panel for Review and Comment September 11 - 14, 2012. Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs Environmental Fate and Effects Division, 

Environmentally Protection Agency, Washington, DC; Environmental Assessment Directorate, Pest Management Regulatory Agency, California Department of Pesticide Regulation. June 19, 2014. 

http://www2.epa.gov/sites/production/files/2014-06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf and USEPA. 2012c. "Field Testing for Pollinators." Ecological Effects Test 

Guidance OCSPP 850.3030. EPA 712-C-017. Web. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0018.

Results for studies conducted for (i) the freshwater green alga, Selenastrum capricornutum, (ii) the freshwater diatom, Navicula pelliculosa, (iii) the marine diatom, Skeletonema costatum, and 

(iv) the cyanobacteria species Anabaena flos-aquae, must be submitted to satisfy this requirement. Final 850 guidelines for the algal testing were posted in June 2012. The Public Draft OPPTS 

850.5400 Algal Toxicity guideline was split into two separate guidelines and renumbered with the cyanobacteria species separated into OCSPP 850.4550 and the other three species under 

OCSPP 850.4500.

OECD has not yet finalized test guidelines for chronic studies, and efforts are underway to develop standardized guidelines for assessing the effects from chronic exposure to adult and larvae 

in the laboratory. Discussion of the study design elements for the 10-day adult toxicity test can be found in Appendix O of the European Food Safety Authority (EFSA) guidance document: 

EFSA. Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees. EFSA Jounral 2013; 11(7):3295, 266 pp. doi: 

Case # and Name:

DCI Number:

Page: 1 of

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.

Use Categories Key:

A - Terrestrial food crop

B - Terrestrial feed crop

C - Terrestrial nonfood crop

I - Greenhouse nonfood crop

J - Forestry use

Q - Residential outdoor use

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Myclobutanil

GDCI-128857-1536

9

10

11

12

13

14

Key: Residue of Concern = Residue of Concern; TEP = Typical End Use Product [TEP]; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI/PAIRA = Technical Grade of the Active Ingredient or Pure Active 

Ingredient, Radio Labelled; TGAI, TEP = Technical Grade of the Active Ingredient or Technical End-Use Product; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient

10.2903/j.efsa.2013.3295.

OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft guidance is being developed, see OECD Draft Guidance Document Honey Bee (Apis mellifera) 

Larval Toxicity Test, Repeated Exposure, http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.pdf

OECD Test Guideline 237 may be used to develop a protocol for this study (OECD. 2013 Guidelines for Testing Chemicals. Honey bee (Apis mellifera) larval toxicity test, single exposure.) See: 

http://www.oecd-ilibrary.org/environment/test-no-237-honey-bee-apis-mellifera-larval-toxicity-test-single-exposure_9789264203723-en.

In some cases, information pertaining to acute toxicity to honey bee larvae may be obtained with the chronic honey bee larvae test thereby negating the need for separate acute and chronic 

larval toxicity tests.

Formal guidelines for semi-field tests do not yet exist; however, information that can help guide the development of either a semi-field tunnel test protocol can be found at OECD 75, see: OECD. 

2007. Series on Testing and Assessment Number 75. Guidance document on the honey bee (Apis mellifera L.) brood test under semi-field conditions. Environmental Directorate Joint Meeting of 

the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. ENV/JM/MONO(2007)22. August 31, 2007. 

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2007)22&doclanguage=en.

For field-feeding studies see the following: Oomen et al. 1992: Oomen, P. A. A. DeRuijter and J. Van der Steen. 1992. Method for honey bee brood feeding tests with insect growth-regulating 

insecticides. Bul OEPP/EPPO Bulletin 22: 613-616.

A study protocol must be submitted to, and reviewed by EPA, prior to study initiation.

Case # and Name:

DCI Number:

Page: 2 of 2
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Myclobutanil

Page: 1 of 1

62719

35935

42750

DOW AGROSCIENCES LLC

NUFARM LIMITED

ALBAUGH, LLC

Co. Nr. Company Name Agent For Company

NUFARM LIMITED

9330 ZIONSVILLE RD 308/2E

4020 AERIAL CENTER PKWY., STE 101

P.O. Box 2127

Address City ZIP

INDIANAPOLIS

MORRISVILLE

VALDOSTA

462681054

27560 

316042127

OMB Approval 2070-0174

State

IN

NC

GA

 DCI Number: GDCI-128857-1536
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Myclobutanil

Page: 1 of 1

62719

35935

42750

DOW AGROSCIENCES LLC

NUFARM LIMITED

ALBAUGH, LLC

Co. Nr. Company Name Agent For Company

NUFARM LIMITED

9330 ZIONSVILLE RD 308/2E

4020 AERIAL CENTER PKWY., STE 101

P.O. Box 2127

Address City ZIP

INDIANAPOLIS

MORRISVILLE

VALDOSTA

462681054

27560 

316042127

OMB Approval 2070-0174

State

IN

NC

GA

 DCI Number: GDCI-128857-1536
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Myclobutanil

Page: 1 of 1

62719

35935

42750

DOW AGROSCIENCES LLC

NUFARM LIMITED

ALBAUGH, LLC

Co. Nr. Company Name Agent For Company

NUFARM LIMITED

9330 ZIONSVILLE RD 308/2E

4020 AERIAL CENTER PKWY., STE 101

P.O. Box 2127

Address City ZIP

INDIANAPOLIS

MORRISVILLE

VALDOSTA

462681054

27560 

316042127

OMB Approval 2070-0174

State

IN

NC

GA

 DCI Number: GDCI-128857-1536