Document ID: EPA-HQ-OPP-2005-0125-0535
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-02-22T05:00Z

SEQ CHAPTER \h \r 1 Appendix B.  Table of Generic Data Requirements
and Studies Used to Make the Reregistration Decision for Metam-sodium,
Metam-potassium, and MITC (PC 039003, 039002, 068103)

GUIDE TO APPENDIX B

	Appendix B contains a listing of data requirements which support the
reregistration for active ingredients within the case covered by this
RED.  It contains generic data requirements that apply to metam-sodium,
metam-potassium, and MITC in all products, including data requirements
for which a “typical formulation” is the test substance.

The data table is organized in the following formats:

Data requirement (Column 1).  The data requirements are listed in the
order in which they appear in 40 CFR 158.  The reference numbers
accompanying each test refer to the test protocols set in the Pesticide
Assessment Guidance, which is available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161.  (703)
487-4650.

Use Pattern (Column 2).  This column indicates the use patterns for
which the data requirements apply.  The following letter designations
are used for the given use patterns.

Terrestrial food

Terrestrial feed

Terrestrial non-food

Aquatic food

Aquatic non-food outdoor

Aquatic non-food industrial

Aquatic non-food residential

Greenhouse food

Greenhouse non-food

Forestry

Residential

Indoor food

  Indoor non-food

  Indoor medical

  Indoor residential

X .   Materials preservatives

Y.    Industrial processes and    water systems-once through

Z.    Industrial processes and water  systems-not once through

BB. Wood preservatives

FF.  High Exposure Antimicrobial

GG. Low Exposure Antimicrobial



3.  Bibliographic Citation (Column 3).  If the Agency has acceptable
data in its files, this column lists the identifying number of each
study.  This normally is the Master Record Identification (MRID) number,
but may be a “GS” number is no MRID number has been assigned.  Refer
to the Bibliography appendix for a complete citation of the study.

 

Data Requirement	Use Patterns	Citations

New Guideline Number	Old Guideline Number	Description

PRODUCT CHEMISTRY

830.1600	61-2A	Description of materials used to produce the product	ALL
41241601, 44453602, 00162081, 44459101, 43953901

830.1620	61-2B	Description of production process	ALL	41241601, 44453602,
00162081, 44459101, 43953901

830.1670	61-2B	Formation of Impurities	ALL	41241601, 44453602, 00162081,
43953901

830.1700	62-1	Preliminary Analysis	ALL	41241602, 44453603, 00162080

830.6302	63-2	Color	ALL	41241603, 41286003, 00162079, 45919401

830.6303	63-3	Physical State	ALL	41241603, 41286003, 43457708, 00162079,
45919401

830.6304

	63-4	Odor	ALL	41241603, 41286003, 43457708, 00162079, 45919401

830.6313	63-13	Stability to normal and elevated temperatures, metals,
and metal ions	ALL	41241603, 41286003, 00162079

830.7000	63-12	pH	ALL	41241603, 41286003, 43457708, 00162079

830.7050	None	UV/Visible Absorption	ALL	45919401, 45919401, DATA GAP

830.7200

Melting Point/melting range	ALL	45919401

830.7220	63-6	Boiling Point/boiling range	ALL	41241603, 41286003,
45919401 

830.7300	63-7	Density	ALL	41241603, 41286003, 43457708, 00162079,
45919401

830.7370	63-10	Dissociation Constants in Water	ALL	41241603, 41286003,
45919404, 

830.7550	63-11	Partition coefficient, shake flask method	ALL	41241603,
41286003, 45919401

830.7840	63-8	Water solubility: column elution method; shake flask
method	ALL	41241603, 41286003, 45919401, 45919403

830.7950

	63-9	Vapor Pressure	ALL	41241603, 41286003, 45919401

ECOLOGICAL EFFECTS

850.1010	72-2   	Acute Toxicity to Freshwater Invertebrates	ALL
41106203, 40098001, 42680601, 41819302, 45919419

850.1025	72-3B	Estuarine/Marine Toxicity – Mollusk	ALL	42632201, DATA
GAP

850.1035	72-3C	Estuarine/Marine Toxicity – Shrimp	ALL	42476301,
43457708, DATA GAP

850.1075	72-1A	Fish Acute Toxicity Bluegill	ALL	42363201, 44523412 ,
DATA GAP

850.1075	72-1B	Fish Acute Toxicity – Rainbow Trout	ALL	42363202,
44523413, 45919420

850.1075	72-3A	Estuarine/Marine Toxicity – Fish	ALL	42436301, DATA GAP

850.1300

Aquatic Invertebrate Lifecycle (Freshwater)	ALL	45634001

850.2100	71-1A	Avian Acute Oral Toxicity – Mallard 	ALL	41476402

850.2200	71-2a,b	Avian Dietary	ALL	41476403, 42914001, 00022923, 

42914002, 41476401, 00022923

850.2300

Avian Reproduction	ALL	DATA GAP

850.3020	141-1

	Honey bee acute contact LD50	ALL	00018842, DATA GAP

850.4225	122-1(a)	Seedling Emergence, Tier II	ALL	DATA GAP

850.4250	122-1(b)	Vegetative Vigor, Tier II	ALL	45919421, 45919422,
45919416, 44588903, DATA GAP

850.5400	122-2B	Aquatic Plant Growth, Tier II	ALL	DATA GAP

RESIDUE CHEMISTRY

860.1300

Nature of the Residue - Plants	C, I	41137101 41137102

41137103 436326024

92097021

860.1340

Residue Analytical Method - Plants	C, I	41142502 41631102

41631104 436326014

92098034

860.1360

Multiresidue Method	C, I	41631103

860.1500

Crop Field Trials	C, I	40951601 40951602

40951603 40951606

40951607 40951608

40951609 41097001 41097002 41097003

41142501 41142502

41142503 41218101

41218102 41218103

41218104 92098035

92098036 92098037

92098038 92098039

92098040 92098041

92098042 92098043

92098044 92098045

92098046 92098047

92098048 92098049

92098050 92098051

92098052 92098053

92098054 92098055, 45703705 43703706 43703707 45123901

TOXICOLOGY

870.1100	81-1	Acute Oral Toxicity - Rat	ALL	41277002, 00162331

870.1200	81-2	Acute Dermal Toxicity – Rat	ALL	41277003, 00162330,
42442501

870.1300	81-3	Acute Inhalation Toxicity – Rat 	ALL	41277004, 00162327,
42365605

870.2400	81-4	Primary Eye Irritation  - Rabbit	ALL	44400401, 41277005,
00162328

870.2500	81-5	Primary Skin Irritation – Rabbit 	ALL	41277006, 00162329

870.2600	81-6	Dermal Sensitization	ALL	41277007

870.3200	82-2	21-Day Dermal – Rabbit/Rat	ALL

	870.3100

Subchronic Feeding – Rat/Mouse 	ALL	41865502, 42117302, 42117301

870.3150

Subchronic Feeding – Dog 	ALL

	870.3465	82-5	90- Day Inhalation Toxicity – Rat/Mouse	ALL	00162041,
43514802, 00162041

870.3700	83-3A	Developmental Toxicity – Rat	ALL	41577101, DATA GAP

870.3800	83-4	Reproduction and Developmental Effects	ALL	DATA GAP

870.4100	83-1B	Chronic Feeding Toxicity Study - Dog	ALL	43275801

870.4200	83-2	Carcinogenicity – Mouse/Rat	ALL	47067501, 43275802, DATA
GAP

870.5100	84-2	Bacterial Reverse Mutation Test (Ames Assay)	ALL	40305602,
305603

870.5375	84-2	Chromosomal Aberration in Chinese Hamster Ovary	ALL
40305605

870.5395	84-2	Unscheduled DNA Synthesis – Rat 	ALL	40305601, DATA GAP

870.5700	84-2	In vitro mammalian gene mutation test	ALL	40305604

870.6200a	81-8   	Acute neurotoxicity screen study in rats,
Inhalation Acute Neurotoxicity	ALL	43465302, 42977801,

42977802, DATA GAP

870.7800	85-7	Immunotoxicity	ALL	DATA GAP

ENVIRONMENTAL FATE

835.1230	163-1	Soil Adsorption	ALL	00152844

835.1240	163-1	Leaching/Adsorption/Desorption	ALL	47010302

835.8100	163-3	Field Volatility	ALL	47066501, 45703701, 45703702,
46969601, 47572201, 47131601, 47314301, 45703708, 45703704, 42659901,
46379201, 47770001, 48011601, 48005901, 47956901, 48115101, 47813901,
47956701, DATA GAP

835.2120	161-1	Hydrolysis	ALL	41631101, 00158162

835.2240	161-2	Photodegradation - Water	ALL	41517701

835.2410	161-3	Photodegradation - Soil	ALL	42978701

835.4100	162-1	Aerobic Soil Metabolism	ALL	40198502

835.4400	162-3	Anaerobic Aquatic Metabolism	ALL	43596501

835.6100	164-1	Terrestrial Field Dissipation	ALL	41514402, 41798601

OCCUPATIONAL AND RESIDENTIAL EXPOSURE

875.1100

Dermal Exposure – Outdoor	F	DATA GAP

875.1200	233	Dermal Exposure – Indoor	X, Y, Z, BB, FF, GG	DATA GAP

875.1300	232	Inhalation Exposure – Outdoor (Applicator)	X, Y, Z, BB,
FF, GG	42968401, 45123902, 45703703, 

875.1400	234	Inhalation Exposure – Indoor	X, Y, Z, BB, FF, GG	DATA GAP

875.1600	235	Application exposure monitoring data reporting	X, Y, Z, BB,
FF, GG	DATA GAP

875.1700	236	Product Use Information	X, Y, Z, BB, FF, GG	DATA GAP

875.2500	133-4	Inhalation Exposure – Outdoor (Post-Application)	X, Y,
Z, BB, FF, GG	42968402, 45703703, DATA GAP

875.2700	235	Product Use Information	X, Y, Z, BB, FF, GG	DATA GAP

875.2800	133-1	Description of Human Activity	X, Y, Z, BB, FF, GG	DATA
GAP

875.2900	134	Data Reporting and Calculations	X, Y, Z, BB, FF, GG	DATA
GAP

Special 	NA	Fumigant Buffer Zone Posting Signs	C, I	DATA GAP

Special 	NA	Training for Applicators Supervising Fumigations	C, I	DATA
GAP

Special	NA	Training Material for Handlers	C, I	DATA GAP