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 - Fluroxypyr 1-methylheptyl ester

Chemical # and Name: 128968

Fluroxypyr 1-methylheptyl ester

01-Mar-2016

GENERIC

ID # GDCI-128968-1498

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page 1 of 1

62719-285

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

NUFARM LIMITED

4020 AERIAL CENTER PKWY., STE 101

MORRISVILLE, NC 27560 

N/A - Fluroxypyr 1-methylheptyl ester

Chemical # and Name: 128968

Fluroxypyr 1-methylheptyl ester

01-Mar-2016

GENERIC

ID # GDCI-128968-1498

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page 1 of 1

35935-53

35935-74

35935-77

35935-90

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

N/A

N/A

N/A

N/A

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 _________________________________________________________________

DOW AGROSCIENCES LLC

9330 ZIONSVILLE RD 308/2E

INDIANAPOLIS, IN 462681054

835.6100

850.3040

850.4100

850.4150

850.4500

SS-1113

SS-1237

SS-1311

SS-1312

Terrestrial field dissipation

Field testing for pollinators

Seedling Emergence and Seedling Growth

Vegetative Vigor

Algal Toxicity

Residue Analysis of Nectar and Pollen in Flowering 

Crops

Dissipation Study in Compost

Honey bee adult acute oral toxicity

Honey bee larvae acute oral toxicity

N/A - Fluroxypyr 1-methylheptyl ester

Chemical # and Name: 128968

Fluroxypyr 1-methylheptyl ester

01-Mar-2016

GENERIC

ID # GDCI-128968-1498

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

TGAI

TEP

TGAI

TGAI

TGAI

TEP

TEP

TGAI

TGAI

12

24

12

12

12

24

12

12

12

Page 1 of 

(8)

(6, 7, 9)

(9)

(9)

(9)

(9, 11, 14)

(10, 12, 13, 

15)

(2, 9)

(5, 9)

N

Y

N

N

N

Y

Y

Y

Y

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

DOW AGROSCIENCES LLC

9330 ZIONSVILLE RD 308/2E

INDIANAPOLIS, IN 462681054

SS-1313

SS-1314

SS-1315

Honey bee adult chronic oral toxicity

Honey bee larvae chronic oral toxicity

Semi-field testing for pollinators 

N/A - Fluroxypyr 1-methylheptyl ester

Chemical # and Name: 128968

Fluroxypyr 1-methylheptyl ester

01-Mar-2016

GENERIC

ID # GDCI-128968-1498

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

TGAI

TGAI

TGAI

12

12

24

Page 2 of 

(3, 9)

(4, 9)

(1, 9)

Y

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 _________________________________________________________________

NUFARM LIMITED

4020 AERIAL CENTER PKWY., STE 101

MORRISVILLE, NC 27560 

835.6100

850.3040

850.4100

850.4150

850.4500

SS-1113

SS-1237

SS-1311

SS-1312

Terrestrial field dissipation

Field testing for pollinators

Seedling Emergence and Seedling Growth

Vegetative Vigor

Algal Toxicity

Residue Analysis of Nectar and Pollen in Flowering 

Crops

Dissipation Study in Compost

Honey bee adult acute oral toxicity

Honey bee larvae acute oral toxicity

N/A - Fluroxypyr 1-methylheptyl ester

Chemical # and Name: 128968

Fluroxypyr 1-methylheptyl ester

01-Mar-2016

GENERIC

ID # GDCI-128968-1498

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

TGAI

TEP

TGAI

TGAI

TGAI

TEP

TEP

TGAI

TGAI

12

24

12

12

12

24

12

12

12

Page 1 of 

(8)

(6, 7, 9)

(9)

(9)

(9)

(9, 11, 14)

(10, 12, 13, 

15)

(2, 9)

(5, 9)

N

Y

N

N

N

Y

Y

Y

Y

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

NUFARM LIMITED

4020 AERIAL CENTER PKWY., STE 101

MORRISVILLE, NC 27560 

SS-1313

SS-1314

SS-1315

Honey bee adult chronic oral toxicity

Honey bee larvae chronic oral toxicity

Semi-field testing for pollinators 

N/A - Fluroxypyr 1-methylheptyl ester

Chemical # and Name: 128968

Fluroxypyr 1-methylheptyl ester

01-Mar-2016

GENERIC

ID # GDCI-128968-1498

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

J,DD,T,S,I,H,G,F,E,R

TGAI

TGAI

TGAI

12

12

24

Page 2 of 

(3, 9)

(4, 9)

(1, 9)

Y

Y

Y

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Fluroxypyr 1-methylheptyl ester

GDCI-128968-1498

1

2

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

o 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 lower-tiered tests and/or other lines of evidence, and the need for a 

refined pollinator risk assessment.

o 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. 31-Aug-2007. 

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

o For field-feeding studies see: 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.

o See also the guidance identified in the EPA document, Guidance Implementation of Exposure and Effects Testing for Assessing Risks to Bees, Appendix 2. 

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

o See the OECD 213: OECD Guidelines for the Testing of Chemicals. Honeybees, Acute Oral Toxicity Test. 213. http://lysander.sourceoecd.org/vl=5988235/cl=12/nw=1/rpsv/cgibin/fulltextew.pl?prpsv=/ij/oecdjournals/1607310x/v1n2/s14/p1.idx

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:

E - Aquatic nonfood outdoor use

F - Aquatic nonfood industrial use

G - Aquatic non-food residential

H - Greenhouse food crop

I - Greenhouse nonfood crop

J - Forestry use

R - Agricultural premises and equipment

S - Food handling/storage establishments premises

and equipment

T - Commercial, institutional and industrial premises

and equipment

DD - Aquatic areas

3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Fluroxypyr 1-methylheptyl ester

GDCI-128968-1498

3

4

5

6

7

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

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

o 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 Journal 2013;11(7):3295, 266 pp. doi:10.2903/j.efsa.2013.3295. 

Available online at: http://www.efsa.europa.eu/en/efsajournal/doc/3295.pdf

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

o OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft guidance has is being developed, see OECD 2013b. 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

o 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.

o See also the guidance identified in the EPA document, Guidance Implementation of Exposure and Effects Testing for Assessing Risks to Bees, Appendix 1.

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

o 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 

o 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. 

 

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

The need for this test is contingent upon results of lower tier pollinator tests. Protocol is required for this test.

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. 

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, 

Environmental Protection Agency, Washington DC; Environmental Assessment Directorate, Pest Management Regulatory Agency, Health Canada, Ottawa, CN; California Department of Pesticide 

Regulation http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2012-0543-0004; (ii) 2014 Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs United States 

Environmental Protection Agency, Health Canada 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, (iii) EPAs Guidance Implementation of Exposure and Effects Testing 

for Assessing Risks to Bees, Appendix 3. 

USEPA. 2012c. "Field Testing for Pollinators." Ecological Effects Test Guidelines OCSPP 850.3040. EPA 712-C-017. Web. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-

0154-0018 

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

Case # and Name:

DCI Number:

Page: 2 of 3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Fluroxypyr 1-methylheptyl ester

GDCI-128968-1498

8

9

10

11

12

13

14

15

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 ILV for fluroxypyr-MHE must include both the degradate fluroxypyr acid and the MHE.

-As referenced in the problem formulation as well as in the EFED response to comments, studies should be conducted for: 

1. Environmental Chemistry Analytical Method for Soil and Associated Independent Laboratory Validation, 

2. Environmental Chemistry Analytical Method in Water and Associated Laboratory Validation.

Test is for MHE only.

Study is for both fluroxypyr-MHE and the degradate fluroxypyr acid.

Measurements of residues in the pollen/nectar are needed based upon lower-tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment.

A study protocol must be submitted to, and reviewed by EPA, prior to study initiation. The following elements should be considered when developing study protocol(s) for the monitoring of

residues in pollen/nectar.

Consideration of the range of application methods and environmental conditions (e.g., soil and hydric regimes) that the target crop(s) may be under.

Consideration of the attractiveness of the selected crop to pollinators

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.

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.

Consideration of the market proportion of the selected target crop(s).

Compost must be derived from clippings of turf grass treated with fluroxypyr-MHE. Fluroxypyr must be applied to the turf as a TEP, with typical application methods at the maximum application 

rate of 0.72 lb a.i/A. The composting methods should represent typical use methods for commercial or municipal processing of grass-based compost.

The study should measure the concentration of fluroxypyr-MHE, fluroxypyr acid and major degradation products over time and establish dissipation half-lives for fluroxypyr-MHE and fluroxypyr 

acid.

Additional data are needed to address deficiencies of the previously submitted study. See the EPA document Problem Formulation and the Drinking Water Exposure Assessment for ecological 

risks and details of these deficiencies.

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

A protocol must be submitted and approved by the Agency prior to the study.

Case # and Name:

DCI Number:

Page: 3 of 3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Fluroxypyr 1-methylheptyl ester

GDCI-128968-1498

1

2

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

o 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 lower-tiered tests and/or other lines of evidence, and the need for a 

refined pollinator risk assessment.

o 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. 31-Aug-2007. 

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

o For field-feeding studies see: 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.

o See also the guidance identified in the EPA document, Guidance Implementation of Exposure and Effects Testing for Assessing Risks to Bees, Appendix 2. 

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

o See the OECD 213: OECD Guidelines for the Testing of Chemicals. Honeybees, Acute Oral Toxicity Test. 213. http://lysander.sourceoecd.org/vl=5988235/cl=12/nw=1/rpsv/cgibin/fulltextew.pl?prpsv=/ij/oecdjournals/1607310x/v1n2/s14/p1.idx

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:

E - Aquatic nonfood outdoor use

F - Aquatic nonfood industrial use

G - Aquatic non-food residential

H - Greenhouse food crop

I - Greenhouse nonfood crop

J - Forestry use

R - Agricultural premises and equipment

S - Food handling/storage establishments premises

and equipment

T - Commercial, institutional and industrial premises

and equipment

DD - Aquatic areas

3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Fluroxypyr 1-methylheptyl ester

GDCI-128968-1498

3

4

5

6

7

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

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

o 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 Journal 2013;11(7):3295, 266 pp. doi:10.2903/j.efsa.2013.3295. 

Available online at: http://www.efsa.europa.eu/en/efsajournal/doc/3295.pdf

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

o OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft guidance has is being developed, see OECD 2013b. 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

o 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.

o See also the guidance identified in the EPA document, Guidance Implementation of Exposure and Effects Testing for Assessing Risks to Bees, Appendix 1.

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

o 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 

o 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. 

 

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

The need for this test is contingent upon results of lower tier pollinator tests. Protocol is required for this test.

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. 

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, 

Environmental Protection Agency, Washington DC; Environmental Assessment Directorate, Pest Management Regulatory Agency, Health Canada, Ottawa, CN; California Department of Pesticide 

Regulation http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2012-0543-0004; (ii) 2014 Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs United States 

Environmental Protection Agency, Health Canada 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, (iii) EPAs Guidance Implementation of Exposure and Effects Testing 

for Assessing Risks to Bees, Appendix 3. 

USEPA. 2012c. "Field Testing for Pollinators." Ecological Effects Test Guidelines OCSPP 850.3040. EPA 712-C-017. Web. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-

0154-0018 

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

Case # and Name:

DCI Number:

Page: 2 of 3
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

N/A - Fluroxypyr 1-methylheptyl ester

GDCI-128968-1498

8

9

10

11

12

13

14

15

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 ILV for fluroxypyr-MHE must include both the degradate fluroxypyr acid and the MHE.

-As referenced in the problem formulation as well as in the EFED response to comments, studies should be conducted for: 

1. Environmental Chemistry Analytical Method for Soil and Associated Independent Laboratory Validation, 

2. Environmental Chemistry Analytical Method in Water and Associated Laboratory Validation.

Test is for MHE only.

Study is for both fluroxypyr-MHE and the degradate fluroxypyr acid.

Measurements of residues in the pollen/nectar are needed based upon lower-tiered tests and/or other lines of evidence, and the need for a refined pollinator risk assessment.

A study protocol must be submitted to, and reviewed by EPA, prior to study initiation. The following elements should be considered when developing study protocol(s) for the monitoring of

residues in pollen/nectar.

Consideration of the range of application methods and environmental conditions (e.g., soil and hydric regimes) that the target crop(s) may be under.

Consideration of the attractiveness of the selected crop to pollinators

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.

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.

Consideration of the market proportion of the selected target crop(s).

Compost must be derived from clippings of turf grass treated with fluroxypyr-MHE. Fluroxypyr must be applied to the turf as a TEP, with typical application methods at the maximum application 

rate of 0.72 lb a.i/A. The composting methods should represent typical use methods for commercial or municipal processing of grass-based compost.

The study should measure the concentration of fluroxypyr-MHE, fluroxypyr acid and major degradation products over time and establish dissipation half-lives for fluroxypyr-MHE and fluroxypyr 

acid.

Additional data are needed to address deficiencies of the previously submitted study. See the EPA document Problem Formulation and the Drinking Water Exposure Assessment for ecological 

risks and details of these deficiencies.

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

A protocol must be submitted and approved by the Agency prior to the study.

Case # and Name:

DCI Number:

Page: 3 of 3
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Fluroxypyr 1-methylheptyl ester

Page: 1 of 1

62719

35935

DOW AGROSCIENCES LLC

NUFARM LIMITED

Co. Nr. Company Name Agent For Company

NUFARM LIMITED

9330 ZIONSVILLE RD 308/2E

4020 AERIAL CENTER PKWY., STE 101

Address City ZIP

INDIANAPOLIS

MORRISVILLE

462681054

27560 

OMB Approval 2070-0174

State

IN

NC

 DCI Number: GDCI-128968-1498
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: N/A - Fluroxypyr 1-methylheptyl ester

Page: 1 of 1

62719

35935

DOW AGROSCIENCES LLC

NUFARM LIMITED

Co. Nr. Company Name Agent For Company

NUFARM LIMITED

9330 ZIONSVILLE RD 308/2E

4020 AERIAL CENTER PKWY., STE 101

Address City ZIP

INDIANAPOLIS

MORRISVILLE

462681054

27560 

OMB Approval 2070-0174

State

IN

NC

 DCI Number: GDCI-128968-1498