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



### 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 _________________________________________________________________ MCLAUGHLIN GORMLEY KING COMPANY 8810 TENTH AVE NORTH MINNEAPOLIS, MN 554274319

Environmental Fate Data Requirements (Conventional Chemical)
Terrestrial and Aquatic Nontarget Organisms Data Requirements (Conventional Chemical) 835.6100

850.1010 850.1025

835.1230 835.1240 835.2120 Terrestrial field dissipation

Aquatic invertebrate acute toxicity, test, freshwater daphnids Oyster acute toxicity test (shell deposition)

Sediment and soil absorption/desorption for parent and degradates Soil column leaching Hydrolysis of parent and degradates as a function of pH at 25 C 3128 - Sabadilla alkaloids Chemical # and Name: 002201 Sabadilla alkaloids GENERIC ID # GDCI-002201-1577

B,A

B,A B,A

B,A B,A B,A TEP

TGAI TGAI

COMMENT COMMENT COMMENT 12

12 12

12 12 12 1 of Page

(31, 39)

(38, 41) (3)

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N N

N N N 7OMB 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



### 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 MCLAUGHLIN GORMLEY KING COMPANY 8810 TENTH AVE NORTH MINNEAPOLIS, MN 554274319

835.2240 835.2410 835.4100 835.4300 835.4400 850.1035 850.1075 850.1300 850.1350 Direct photolysis rate of parent and degradates in

water Photodegradation of parent and degradates in soil Aerobic soil metabolism Aerobic aquatic metabolism Anaerobic aquatic metabolism Mysid acute toxicity test Fish acute toxicity test, freshwater and marine Daphnid chronic toxicity test Mysid chronic toxicity test 3128 - Sabadilla alkaloids Chemical # and Name: 002201 Sabadilla alkaloids GENERIC ID # GDCI-002201-1577

B,A B,A B,A B,A B,A B,A B,A B,A B,A COMMENT COMMENT COMMENT COMMENT COMMENT TGAI TGAI TGAI TGAI 12 12 24 24 12 12 12 12 12 2 of Page

(28) (28) (11) (11) (28) (6) (13) (24) (7) N N N N N N N N N 7OMB 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



### 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 MCLAUGHLIN GORMLEY KING COMPANY 8810 TENTH AVE NORTH MINNEAPOLIS, MN 554274319

850.1400 850.1730 850.1735 850.1740 850.2100 850.2200 850.2300 850.3040 850.4100 850.4150 Fish early-life stage toxicity test

Fish BCF Whole sediment: acute freshwater invertebrates Whole sediment: acute marine invertebrates Avian acute oral toxicity test Avian dietary toxicity test Avian reproduction test Field testing for pollinators Seedling Emergence and Seedling Growth Vegetative Vigor 3128 - Sabadilla alkaloids Chemical # and Name: 002201 Sabadilla alkaloids GENERIC ID # GDCI-002201-1577

B,A B,A B,A B,A B,A B,A B,A B,A B,A B,A TGAI COMMENT TGAI TGAI TGAI TGAI TGAI TEP TEP TEP 12 12 12 12 12 12 24 24 12 12 3 of Page

(12) (28) (2, 37) (4, 36) (14) (5) (15) (1, 23) (27) (9) N N N N N N N N N N 7OMB 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



### 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 MCLAUGHLIN GORMLEY KING COMPANY 8810 TENTH AVE NORTH MINNEAPOLIS, MN 554274319

850.4400 850.4500 850.4550 850.6100 860.1100 860.1300 860.1340 860.1360 860.1380 Aquatic Plant Toxicity Using Lemna spp

Algal Toxicity Cyanobacteria (Anabaena flos-aquae) Toxicity Environmental Chemistry Methods and Associated Independent Laboratory Validation Chemical identity Nature of the residue - plants, livestock Residue analytical method Multiresidue method Storage stability data 3128 - Sabadilla alkaloids Chemical # and Name: 002201 Sabadilla alkaloids GENERIC ID # GDCI-002201-1577

B,A B,A B,A B,A B,A B,A B,A B,A B,A TGAI TGAI TGAI TGAI TGAI TGAI Residue of Concern Residue of Concern Residue of Concern 12 12 12 24 6 24 24 24 24 4 of Page

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(21) N N N N N N N N N 7OMB 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



### 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 MCLAUGHLIN GORMLEY KING COMPANY 8810 TENTH AVE NORTH MINNEAPOLIS, MN 554274319

860.1480 860.1500 860.1520 860.1650 860.1850 860.1900 870.3150 870.3200 870.3465 870.3700 Meat/milk/poultry/eggs

Crop field trials (CROP, IRRIGATED) Processed food/feed (CITRUS) Submittal of analytical reference standards Confined accumulation in rotational crops Field accumulation in rotational crops 90-day oral toxicity in nonrodents 21/28-day dermal toxicity 90-day inhalation toxicity Prenatal developmental toxicity study 3128 - Sabadilla alkaloids Chemical # and Name: 002201 Sabadilla alkaloids GENERIC ID # GDCI-002201-1577

B,A B,A B,A B,A B,A B,A B,A B,A B,A B,A TGAI TEP TEP TGAI TEP TEP TGAI TGAI TGAI TGAI 24 24 24 12 24 24 24 24 24 24 5 of Page

(43) N N N N N N N N N N 7OMB 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



### 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 MCLAUGHLIN GORMLEY KING COMPANY 8810 TENTH AVE NORTH MINNEAPOLIS, MN 554274319

870.3800 870.4200 870.6200 870.7485 870.7800 875.2000 875.2100 SS-1256 SS-1257 Reproduction and fertility effects

Carcinogenicity Neurotoxicity screening battery Metabolism and pharmacokinetics Immunotoxicity Background for postapplication exposure monitoring test guidelines Foliar dislodgeable residue dissipation Acute oral toxicity--honeybee adult Acute oral toxicity--honeybee larvae 3128 - Sabadilla alkaloids Chemical # and Name: 002201 Sabadilla alkaloids GENERIC ID # GDCI-002201-1577

B,A B,A B,A B,A B,A B,A B,A B,A B,A TGAI TGAI TGAI TGAI TGAI TGAI TGAI TGAI TGAI 48 48 12 24 12 24 24 12 12 6 of Page

(20) (42)

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N N N N N N Y Y 7Date 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



### 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 MCLAUGHLIN GORMLEY KING COMPANY 8810 TENTH AVE NORTH MINNEAPOLIS, MN 554274319

SS-1315 SS-1344 SS-1346 SS-1353 SS-WholeSedIn Semi-field testing for pollinators

Chronic Oral Toxicity - Larval Honeybee Chronic Oral Toxicity - Adult Honeybee Residues in pollen and nectar Whole sediment: Chronic invertebrates (freshwater & marine) 3128 - Sabadilla alkaloids Chemical # and Name: 002201 Sabadilla alkaloids GENERIC ID # GDCI-002201-1577

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(22, 44) (34, 44) (30, 33, 44) (10, 35, 44) (18, 29, 44) Y

Y Y Y Y 7

### United States Environmental Protection Agency Washington, D.C. 20460 FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS 3128 - Sabadilla alkaloids GDCI-002201-1577

1 2 3 4 5 6 7 8 9 10 11 12

13 14 15 16 17 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

Tier III: Test material is Sabadilla alkaloids TEP. Tier II: Test with Sabadilla alkaloids; this study will be needed if KOC values are analytically confirmed to be consistent with those predicted by EPISuite. Tier II: Test with Sabadilla alkaloids; the need for these data will be determined based on the results from the (Tier I) testing under OCSPP Guideline #850.1300. Preferred test species is eastern oyster. Tier II: Test with Sabadilla alkaloids. This study will be needed if KOC values are analytically confirmed to be consistent with those predicted by EPISuite. The requirement is for a 10-day subchronic study. Tier II: Test substance is Sabadilla alkaloids. Bobwhite quail and mallard duck are the preferred test species. The need for Tier II data is dependent on the results of Tier I testing (OCSPP Guideline 850.2100 Avian Acute Oral Toxicity with bobwhite quail and OCSPP Guideline 850.2300 Avian Reproduction with bobwhite quail). Tier II: Test material is Sabadilla alkaloids. The need for these data is pending based on the results of the Tier I test (OCSPP Guideline 850.1300). Mysid shrimp is the preferred test species. Tier II: Test with Sabadilla alkaloids. The need for Tier II data is dependent on the results of the Tier I testing under OCSPP Guideline #850.1300. Tier II: Test substance is sabadilla alkaloids; test species is Anabaena flos-aquae. The need for Tier II testing is dependent on the results of Tier I testing under OCSPP Guidelines 850.4400 Aquatic Vascular Plant Toxicity Test with Lemna spp., and 850.4500 Algal Toxicity with Pseudokirchneriella subcapitata. Tier II: Test substance is Sabadilla alkaloids TEP. The need for Tier II testing is dependent on the results of testing under OCSPP Guideline 850.4100. Tier II: Test material is Sabadilla alkaloids. Tier I: Test with veratridine; Tier II:Test with cevadine. The need for Tier II testing is dependent on the results of Tier I testing under this guideline. Tier I: Test with Sabadilla alkaloids, freshwater fish, cold water species. Tier II: Test with Sabadilla alkaloids, freshwater fish, warm water species, and estuarine/marine species. The need for the Tier II studies is dependent on the results of the Tier 1 study for this guideline (OCSPP 850.1400). Tier I: Test with Sabadilla alkaloids, 1 freshwater fish (cold water species) Tier II: Test with Sabadilla alkaloids, 1 freshwater fish (warm water species) and 1 estuarine/marine species. The need for Tier II testing is dependent on the results of Tier I testing under this guideline. Tier I: Test substance is Sabadilla alkaloids; the preferred test species is bobwhite quail. Tier II: Test substance is Sabadilla alkaloids; the preferred test species are mallard duck and a passerine species. The need for the Tier II data is dependent on the results of the Tier I study under this Guideline. Tier I: Test substance is Sabadilla alkaloids; bobwhite quail is the preferred test species. Tier II: Test substance is Sabadilla alkaloids; mallard duck is the preferred test species. The need for Tier II data is dependent on the results of Tier I testing (OCSPP Guidelines 850.2100 Avian Acute Oral Toxicity with bobwhite quail, and 850.2300 Avian Reproduction with bobwhite quail). Tier I: Test material is veratridine; Tier II: Test material is cevadine. The need for Tier II testing is dependent on the results of Tier I testing under this guideline. Tier I testing: Test material is sabadilla alkaloids; test species is Pseudokirchneriella subcapitata. Tier II testing: Test material is sabadilla alkaloids; test species are Skeletonema costatum and Case # and Name: DCI Number: 1 Page: 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 4

### United States Environmental Protection Agency Washington, D.C. 20460 FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS 3128 - Sabadilla alkaloids GDCI-002201-1577

18 19 20 21 22

23 24 25 26 27 28 29 30 31 32

33 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

Navicula pelliculosa. The need for Tier II testing is dependent on the results of the Tier I studies under OCSPP Guidelines 850.4400 Aquatic Vascular Plant Toxicity Test with Lemna spp., and 850.4500 Algal Toxicity with Pseudokirchneriella subcapitata This DCI includes both Tier I and Tier II components for some environmental fate and ecological toxicity data requirements. For this study and all others with higher tier components, the need for the higher tier data will be determined based on the results of the lower tier testing. The test substance is veratridine. The preferred test species is rat. The preferred test species for plants are selected to represent the registered use sites. The registrant should meet with the Agency to discuss test species prior to initiating the study. The preferred test species in livestock are lactating goat and laying hen. The need for a field or 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--Sabadilla Tier II Data Requirement. 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. 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. The need for a field or a semi-field test for pollinators (i.e., either a field-feeding test or a tunnel test) will be determined based upon lower-tiered pollinator tests and/or other lines of evidence, and the need for a refined pollinator risk assessment. Test with Sabadilla alkaloids Test substance is veratridine. Test substance is Sabadilla alkaloids. Test substance is Sabadilla alkaloids TEP. Test material is veratridine. Test material is sabadilla alkaloids for this Tier II study. Test organism should be the most sensitive species identified from the subchronic studies (850.1735 and 850.1740). Test material is Sabadilla alkaloids. Test material is Sabadilla alkaloids TEP.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 A study protocol must be submitted to, and reviewed by EPA, prior to study initiation. 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. Case # and Name: DCI Number: 2 Page: of 4

### United States Environmental Protection Agency Washington, D.C. 20460 FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS 3128 - Sabadilla alkaloids GDCI-002201-1577

34

35

36 37 38

39 40 41 42 43 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

doi:10.2903/j.efsa.2013.3295. Available online at: http://www.efsa.europa.eu/en/efsajournal/doc/3295.pdf. A study protocol must be submitted to, and reviewed by EPA, prior to study initiation. OECD has not yet finalized test guidelines for chronic studies with honey bee larvae. OECD draft guidance 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. 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. 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. The following elements should be considered when developing study protocol(s) for the monitoring of residues in pollen/nectar. The range of application methods and environmental conditions (e.g., soil and hydric regimes) that the target crop(s) may be under. The attractiveness of the selected crop to pollinators A collection schedule sufficient to allow for an understanding of the character of residues, in the pollen/nectar and/or plant tissues, over time. Whether residues of the active ingredient and/or degradation product(s) accumulate in soil and are bioavailable for plant to uptake in a following planting, and could result in potential exposure to pollinators. Market proportion of the selected target crop(s). 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. A study protocol must be submitted to, and reviewed by EPA, prior to study initiation. Leptocheirus plumulosus is the preferred test species. This requirement is for a sub-chronic test. Hyalella Azteca and Chironomus dilutes are the preferred test species. This requirement is for a 10-day subchronic test. For all studies in which the test material is the sabadilla alkaloids TGAI, TGAI refers to a mixture of sabadilla alkaloids that would be representative of the active ingredient found in the registered product. It has been reported that there is significant variation in the concentrations of individual components of the active ingredient in the finished product. All studies to be conducted with sabadilla alkaloid TGAI should conducted with material containing the same relative proportions of veratridine, cevadine, sabadinine, and sabadine in the mixture. Analytical confirmation of the concentration of each component (veratridine, cevadine, sabadinine, and sabadine) and confirmatory analysis that demonstrates that the sabadilla alkaloids TGAI used for testing is representative of the composition of sabadilla alkaloids contained in Veratran D for all studies using TGAI as the test material. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. The environmental chemistry methods must include a statement of no data confidentiality claims, i.e., the study results will not be considered to be CBI. ECM and ILV are needed for both soil and water. Daphnia magna is preferred test species. Carcinogenicity testing in the mouse and Combined Chronic/Carcinogenicity testing in the rat Based on estimates of the magnitude and duration of human exposure, studies of shorter duration, i.e., 21- or 28-days, may be sufficient to satisfy this requirement. Registrant should consult with the Agency prior to initiation to determine whether studies of shorter duration would satisfy the requirement in this case. Case # and Name: DCI Number: 3 Page: of 4

### United States Environmental Protection Agency Washington, D.C. 20460 FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS 3128 - Sabadilla alkaloids GDCI-002201-1577

44 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

A study protocol must be submitted to, and reviewed by EPA, prior to study initiation. Case # and Name: DCI Number: 4 Page: of 4