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

1. Company Name and Address

 

0234 - Amitraz

Chemical # and Name: 106201

Amitraz

18-Nov-2011

GENERIC

ID # GDCI-106201-1053

United States Environmental Protection Agency

Washington, D.C. 20460

DATA CALL-IN RESPONSE

Page of 1 1

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

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 _________________________________________________________________

 

Environmental Fate Data Requirements (Conventional 

Chemical)

Nontarget Plant Protection Data Requirements (Conventional 

Chemical)

Terrestrial and Aquatic Nontarget Organisms Data 

Requirements (Conventional Chemical)

835.1230

850.4100

850.4150

850.5400

850.2100

Sediment and soil absorption/desorption for parent 

and degradates

Terrestrial Plant Toxicity (Seedling Emergence)

Terrestrial plant toxicity, Tier 1 (vegetative vigor)

Algal toxicity, Tiers 1 and II

Avian acute oral toxicity test

0234 - Amitraz

Chemical # and Name: 106201

Amitraz

18-Nov-2011

GENERIC

ID # GDCI-106201-1053

U,R

U,R

U,R

U,R

U,R

PAIRA; TGAI

TEP

TEP

TEP; TGAI

TEP; TGAI

12

12

12

12

12

Page 1 of 

(5)

(7, 10, 13)

(6, 10, 13)

(11, 13)

(12)

N

N

N

N

Y

2
Date

OMB Approval 2070-0174

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

 

Toxicology Data Requirements (Conventional Chemical)

870.3100

870.3150

870.3250

870.3465

870.3700

870.6200

870.6300

870.7800

90-Day oral toxicity in rodents

90-day oral toxicity in nonrodents

90-day dermal toxicity

90-day inhalation toxicity

Prenatal developmental toxicity study

Neurotoxicity screening battery

Developmental neurotoxicity study

Immunotoxicity

0234 - Amitraz

Chemical # and Name: 106201

Amitraz

18-Nov-2011

GENERIC

ID # GDCI-106201-1053

U,R

U,R

U,R

U,R

U,R

U,R

U,R

U,R

TGAI

TGAI

TGAI/TGAI & EP

TGAI

TGAI

TGAI

TGAI

TGAI

12

12

24

24

24

24

48

12

Page 2 of 

(1)

(9, 12)

(8, 12)

(12)

(3, 4, 12)

(3, 12)

(2, 12)

N

N

Y

Y

Y

Y

Y

Y

2
United States Environmental Protection Agency 

Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

0234 - Amitraz

GDCI-106201-1053

1

2

3

4

5

6

7

8

9

10

11

12

13

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

This study may be combined with the sub-chronic neurotoxicity study, 870.6200.

The successful completion of a modified one-generation reproduction study (GLN 37.3800), which includes pertinent measurements for developmental, neurotoxicity and possible immunotoxicity

parameters may satisfy neurotoxicity, reproduction and immunotoxicity data requirements.

The previously required modified one-generation reproduction study (GLN 370.3800), which includes pertinent measurements for developmental, neurotoxicity and possible immunotoxicity 

parameters may be used to satisfy neurotoxicity, reproduction and immunotoxicity data requirements. If these components of the study are acceptable.

The Agency is requesting an acute and subchronic neurotoxicity study only. The acute neurotoxicity will be used detect possible effects resulting from a single exposure. The sub-chronic 

neurotoxicity study is needed to detect possible effects resulting from repeated or long-term exposures.

The 835.1230 test guideline requires an adsorption and desorption study using batch equilibrium method for the active ingredient, however since the active ingredient undergoes rapid hydrolysis

forming BTS 27271 and BTS 27919; it is prudent to request the batch equilibrium study for those amitraz degradates of concern to fully characterize the potential mobility of the major 

transformation products. Hence, the data requirement is for the 2 degradates only and not for the parent.

Refer to public draft guideline 850.4250 for guidance on Tier II vegetative vigor testing.

Refer to public draft guideline 850.4225 for guidance on Tier II seedling emergence testing. 

Instead of conducting the inhalation study for 90-days, the Agency only needs a 28-day inhalation study because only short- and intermediate-term (but not long-term) exposure to workers is 

expected based on amitraz's use pattern.

Information acquired from this 90-day dermal toxicity study will satisfy the need for the 28-day dermal toxicity data.

Data are required for six species of dicots from at least four families, one species of which is soybean (Glycine max). Data are required for four species of monocots from at least two families,

one species which is corn (Zea mays). At least one of either the monocot or dicot species must be a root crop.

Data are required for a freshwater green alga species, a freshwater diatom species, a marine diatom species, and a cyanobacterium (formerly known as blue-green algae).

A protocol should be submitted to the Agency for review within 90 days of receipt of the amitraz registration review generic data call-in.

A Tier II study is required. A Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct

and submission of a Tier II study as well. The purpose of a Tier II study is to establish both a definitive No Observed Adverse Effect Concentration (NOAEC), or alternatively, a concentration at 

which there is a 5% observed inhibition effect (IC05), to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC25 

(concentration at which there is a 25% observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a Tier I study and neither a definitive 

NOAEC nor a definitive IC05 value is available, then the Agency may have to presume in its effects determination, that Amitraz "may affect" and is "likely to adversely affect" listed plant species.

Case # and Name:

DCI Number:

Page: 1 of 1

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:

R - Agricultural premises and equipment

U - Residential and public access premises
United States Environmental Protection Agency 

Washington, D.C. 20460

LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE

Case # and Name: 0234 - Amitraz

Page: 1 of 1

54382

65331

80490

85904

INTERVET INC

MERIAL LIMITED

FORT DODGE ANIMAL HEALTH

ARYSTA LIFESCIENCE AMERICA INC.

Co. Nr. Company Name Agent For Company

PFIZER, INC.

556 MORRIS AVENUE, S5-2145A

3239 SATELLITE BLVD, BLDG 500, OFFICE 113

7000 PORTAGE RD., KZO 300-403 SW

1450 BROADWAY, 20TH FLOOR

Address City ZIP

SUMMIT

DULUTH

KALAMAZOO

NEW YORK

07901 

300964640

49001 

10018 

OMB Approval 2070-0174

State

NJ

GA

MI

NY

 DCI Number: GDCI-106201-1053
LINKS TO FORMS:

The pesticide registration forms that are listed below can be found at:

http://www.epa.gov/opprd001/forms/

Link to Confidential Statement of Formula and Instructions (Form # 8570-4)

http://www.epa.gov/opprd001/forms/8570-4.pdf

Certification of Attempt to Enter Into an Agreement With Registrants for 

Development of Data (Form # 8570-32)

http://www.epa.gov/opprd001/forms/8570-32.pdf

Certification With Respect to Citation of Data (Form # 8570-34)

http://www.epa.gov/opprd001/forms/8570-34.pdf