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 1 Page of 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 NumberInitial 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



### 2 3 1 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 1 of Page

(5)

(7, 10, 13) (6, 10, 13) (11, 13)

(12) N

N N N

Y 2Date 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



### 2 3 1 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 2 of Page

(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: 1 Page: 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 0234 - Amitraz Case # and Name: 1 Page: 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 C onfidential Statement of Formula and Instructions (Form # 8570 -4 

# ) http://www.epa.gov/opprd001/forms/8570 - 4.pdf C ertification 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
C ertification With Respect to Citation of Data (Form # 8570 - 34 

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