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Temephos RED Appendices

RED Contents | Team | Terms & Abbreviations | Fact Sheet

Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION

Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES USED TO MAKE THE REREGISTRATION DECISION

Appendix C. TECHNICAL SUPPORT DOCUMENTS

Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE SUPPORTING THE REREGISTRATION DECISION (BIBLIOGRAPHY)

Appendix E. GENERIC DATA CALL-IN

Appendix F. PRODUCT SPECIFIC DATA CALL-IN

Appendix G. EPA'S BATCHING OF TEMEPHOS PRODUCTS FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION

Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN

Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND ELECTRONICALLY AVAILABLE FORMS

Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION

TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION

Sites

Pests

Formulation Type & Max Rate

Application Intervals

Non-potable water (stagnant, saline and temporary water bodies)

Waters high in organic content

Highly polluted water

Moist areas

Woodland pools

Shallow ponds

Edges of lakes

Swamps

Marshes

Tidal waters

Intertidal zones

Catch basins

Mosquito-larvae

Midge-larvae

Gnat-larvae

Punkie-larvae

Sandfly-larvae

Granular Products:

0.5 lbs/ai/A

Emulsifiable Concentrate:

1.5 fl. oz./A (0.0469 lbs/ai/A)

7 Days1

Spot Treatment to Lakes

Midge-larvae

Granular Products:

0.5 lbs/ai/A

Emulsifiable Concentrate:

1.5 fl. oz./A (0.0469 lbs/ai/A)

7 Days1

Tire Piles

Mosquito-larvae

Granular Products for tires:

0.05 lbs/ai/100 sq. ft.

7 Days1

1 Unless monitoring indicates that larval populations have reestablished, or weather, or flooding conditions have rendered initial treatments ineffective.

Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES USED TO MAKE THE REREGISTRATION DECISION

GUIDE TO APPENDIX B.

Appendix B. contains 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 in all products, including data requirements for which a "typical formulation" is the test substance.

The data table is organized in the following formats:

1. Data Requirement (Column 1, 2, & 3). The data requirements are listed in the order of Old Guideline Number. The reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidance, which are available from the National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.

2. Use Pattern (Column 4). This column indicates the use patterns for which the data requirements apply. The following letter designations are used for the given use patterns.

A. Terrestrial food

B. Terrestrial feed

C. Terrestrial non-food

D. Aquatic food

E. Aquatic non-food outdoor

F. Aquatic non-food industrial

G. Aquatic non-food residential

H. Greenhouse food

I. Greenhouse non-food

J. Forestry

K. Residential

L. Indoor food

M. Indoor non-food

N. Indoor medical

O. Indoor residential

3. Bibliographic Citation (Column 5). If the Agency has acceptable data in its files, this column list the identify number of each study. This normally is the Master Record Identification (MRID) number, but may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography, Appendix B. for a complete citation of the study.

Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES USED TO MAKE THE REREGISTRATION DECISION

Old Guideline Number

New Guideline Number

Requirement

Use Pattern

Citations

Ecological Effects

71-1 (a)

850.2100

Avian acute oral toxicity - quail

E

00157841, 00001357, 00001354

71-2 (a)

850.2200

Avian dietary toxicity - quail

E

00022923

71-2 (b)

850.2200

Avian dietary - mallard

E

00022923

72-1 (a)

850.1075

Fish toxicity - bluegill

E

40098001, McCann(USDA), 1971

72-1 (b)

850.1075

Fish toxicity - bluegill/TEP-G

E

40098001, McCann(USDA), 1971

72-1 (c)

850.1075

Fish toxicity - rainbow trout

E

40098001, McCann(USDA), 1971

72-1 (d)

850.1075

Fish toxicity - rainbow trout/TEP

E

00001337

72-2 (a)

850.1010

Invertebrate toxicity - stonefly

E

40098001

72-2 (a)

850.1010

Invertebrate toxicity - scud

E

40098001

72-2 (b)

850.1010

Invertebrate toxicity / TEP-G Daphnid

E

05002680, McCann(USDA), 1975

72-2 (b)

850.1010

Invertebrate toxicity / TEP-EC Daphnid

E

00158327, 00001354, 00001357

72-3 (a)

850.1075

Estuarine/Marine toxicity - fish

E

Data Gap

72-3 (b)

850.1055

Estuarine/Marine toxicity - mollusk

E

40098001, 00161091

72-3 (e)

850.1055

Estuarine/Marine toxicity - mollusk/TEP-EC

E

40098001

72-3 (f)

850.1045

Estuarine/Marine toxicity - shrimp/TEP-EC, pink shrimp Penaeus duorum

E

00161090, 00001357

72-6

850.1730

Aquatic organisms accumulation

E

00158327, 00165027

81-1

870.1100

Mammalian

E

00001354, 00001365, 00001368

Toxicology Effects

81-7

870.6100

Acute delayed neurotoxicity - hen

E

Data Gap

81-8

870.6200

Neurotoxicity screening battery - Acute - rat

E

Data Gap

82-1

870.3100

90 day subchronic feeding study in rats

E

00001239

82-1 (a)

870.3100

90 day feeding study in rats - short term dermal

E

00001239

82-1 (a)

870.3100

90 day feeding study in rats - long term dermal

E

00001239

82-2

870.3200

21-day dermal - rat

E

Data Gap

82-5 (b)

870.6100

90-day neurotoxicity - rat

E

Data Gap

83-3 (a)

870.3700

Teratogenicity - rat (STUDY IS RESERVED)

E

Data Gap

83-5

870.4300

Combined chronic toxicity - carcinogenicity study in rats

E

00001385, 00001386

85-3

870.7600

Dermal absorption

E

00101659, 00101660

231

875.1100

Estimation of dermal exposure - outdoor

E

Data Gap

232

875.1300

Estimation of inhalation exposure - outdoor

E

Data Gap

Residue Chemistry

61-1

830.1550

Product identity and composition

E

00001216, 00003268

61-2 (a)

830.1600

Description of materials used to produce the product

E

00001278, GS0006001, GS0006002

61-2 (b)

830.1620

Description of the production process

E

00001278, GS0006001, GS0006002

63-2

830.6302

Color

E

00001379

63-3

830.6303

Physical state

E

00001379

63-5

830.7200

Melting point/melting range

E

00001379

63-7

830.7300

Density/relative density/bulk density

E

00001379

63-8

830.7840

Water solubility: column elution method, shake flask method

E

00001379

63-13

830.6313

Stability to normal and elevated temperatures, metals, and metal ions

E

00001379

n/a

830.1800

Enforcement analytical method

E

05000638

Appendix C. TECHNICAL SUPPORT DOCUMENTS

This Reregistration Eligibility Document is supported by documents that are presently maintained in the OPP docket. The OPP docket is located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday, excluding legal holidays from 8:30 am to 4 pm. All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the Internet. See https://www.epa.gov/pesticides/reregistration/status.htm or https://www.epa.gov/pesticides/.

To obtain a copy of the RED document, please contact either the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200 Pennsylvania Avenue NW, Washington, DC 20460, telephone 703-305-5805 or EPA's National Service Center for Environmental Publications (EPA/NSCEP), PO Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 301-604-3408. Following the comment period, the temephos RED document also will be available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-605-6000.

For more information about EPA's pesticide reregistration program, the temephos RED, or reregistration of individual products containing temephos, please contact the Special Review and Reregistration Division (7508C), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.

Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE SUPPORTING THE REREGISTRATION DECISION (BIBLIOGRAPHY)

GUIDE TO APPENDIX D.

1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration Eligibility Document. Primary sources for studies in this bibliography have been the body of data submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections from other sources including the published literature, in those instances where they have been considered, are included.

2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of published materials, this corresponds closely to an article. In the case of unpublished materials submitted to the Agency, the Agency has sought to identify documents at a level parallel to the published article from within the typically larger volumes in which they were submitted. The resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for purposes of review and can be described with a conventional bibliographic citation. The Agency has also attempted to unite basic documents and commentaries upon them, treating them as a single study.

3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by Master Record Identifier, or "MRID" number. This number is unique to the citation, and should be used whenever a specific reference is required. It is not related to the six-digit "Accession Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the bibliography late in the review may be preceded by a nine character temporary identifier. These entries are listed after all MRID entries. This temporary identifying number is also to be used whenever specific reference is needed.

4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a citation containing standard elements followed, in the case of material submitted to EPA, by a description of the earliest known submission. Bibliographic conventions used reflect the standard of the American National Standards Institute (ANSI), expanded to provide for certain special needs.

a Author. Whenever the author could confidently be identified, the Agency has chosen to show a personal author. When no individual was identified, the Agency has shown an identifiable laboratory or testing facility as the author. When no author or laboratory could be identified, the Agency has shown the first submitter as the author.

b. Document date. The date of the study is taken directly from the document. When the date is followed by a question mark, the bibliographer has deduced the date from the evidence contained in the document. When the date appears as (1999), the Agency was unable to determine or estimate the date of the document.

c. Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance a document title. Any such editorial insertions are contained between square brackets.

d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses include (in addition to any self-explanatory text) the following elements describing the earliest known submission:

(1) Submission date. The date of the earliest known submission appears immediately following the word "received."

(2) Administrative number. The next element immediately following the word "under" is the registration number, experimental use permit number, petition number, or other administrative number associated with the earliest known submission.

(3) Submitter. The third element is the submitter. When authorship is defaulted to the submitter, this element is omitted.

(4) Volume Identification (Accession Numbers). The final element in the trailing parentheses identifies the EPA accession number of the volume in which the original submission of the study appears. The six-digit accession number follows the symbol "CDL," which stands for "Company Data Library." This accession number is in turn followed by an alphabetic suffix which shows the relative position of the study within the volume.

Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE SUPPORTING THE REREGISTRATION DECISION (BIBLIOGRAPHY)

MRID # BIBLIOGRAPHY

00001216 American Cyanamid Company (1974) Description of Processing Procedure: [Temephos]. (Unpublished study received Mar 6, 1974 under 241-234; CDL:026901-D).

00001239 Levinskas, G.J. (1965) Report on CL 52,160: Ninety-Day Feeding to Albino Rats: Report No. 65-18. Method dated Mar 9, 1965 entitled: Modified Michel Method for Assay of Cholinesterase Activity. (Unpublished study received May 27, 1965 under 241-132; submitted by American Cyanamid Co., Princeton, N.J.; CDL:001791-R).

00001278 American Cyanamid Company (1975?) The Specification for Raw Materials used in the Manufacture of Abate® (Unpublished study received Nov 19, 1975 under 241-246; CDL:224604-C).

00001337 Kennedy H.D. (1970) Acute Toxicity of Pesticides to Fish: [Temephos]: Annual Progress Report: 1970. (Unpublished study received Nov 26, 1971 under 241-132; prepared by U.S. Fish and Wildlife Service, Fish-Pesticide Research Laboratory, submitted by U.S. Cyanamid Co., Princeton, N.J.; CDL:129448-AG).

00001354 American Cyanamid Company (1966?) Toxicity Data: Phosphorothioic Acid, O,O,O',O' Tetramethyl O,O' Thiodi-p-Phenylene Ester (Crystalline) [and Abate® Mosquito Larvicide]. (Unpublished study received Feb 3, 1967 under 7G0566; CDL:090712-A).

00001357 Morici, I.J.; Levinskas, G.J. (1965) CL 43,913 and CL 52,160: Seven-Day Repeated Feeding to Young Coturnix Quail: No. 65-44. (Unpublished study received Feb 3, 1967 under C7G0566; submitted by American Cyanamid Co., Princeton, N.J.; CDL:090712-O).

00001365 McNerney, J.M.; Levinskas, G.J. (1967) Abate® Mosquito Larvicide Single Oral Dose Toxicity to Rats and Joint Toxic Action with Other Pesticides: Report nos. 67-45 and 67-169. (Unpublished study received Jul 17, 1967 under 7G0566; submitted by American Cyanamid Co., Princeton, N.J.; CDL: 090713-B).

00001368 Gaines, T.B.; Kimbrough, R.; Laws, E.R., Jr. (1967) Toxicology of Abate® in laboratory animals. Archives of Environmental Health 14(?/Feb): 283-288. (Also unpublished submission received Jul 17, 1967 under 7G0566; submitted by American Cyanamid Co., Princeton, N.J.; CDL:090713-I).

00001379 American Cyanamid Company (1972?) [Chemical and Physical Properties of Abate® Manufacturing Concentrate Insecticide and Formulations]. (Unpublished study received Jan 12, 1972 under 2270-554; CDL:025308-A).

00001385 Shaffer, C.B. (1978) Addendum to Report of Two-Year Chronic Toxicity and Carcinogenesis Study of Temephos in the Rat. (Unpublished study received Apr 4, 1978 under 241-220; submitted by American Cyanamid Co., Princeton, N.J.; CDL:233402-A).

00001386 Underwood, P.C. (1977) Two-Year Chronic Toxicity and Carcinogenesis Study of Temephos in the Rat: Report No. 7354. (Unpublished study received Apr 4, 1978 under 241-220; prepared by Pharmacopathics Research Laboratories, Inc.; submitted by American Cyanamid Co., Princeton, N.J.; CDL:233402-B; 235935).

00003268 American Cyanamid Company (19??) Chemical and Physical Properties of Biothion Insecticide. (Unpublished study received Apr 7, 1971 under 1F1156; CDL:093476-E).

00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of Environmental Pollutants to Birds: Special Scientific Report--Wildlife No. 191. (U.S. Dept. of the Interior, Fish and Wildlife Service, Patuxent Wildlife Research Center; unpublished report).

00101659 Beliles, R.; Makris, S. (1978) Final Report: Teratology Study in Rabbits: LBI Project No. 20740-B. (Unpublished study received May 14, 1982 under 241-220; prepared by Litton Bionetics, Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL:247537-K).

00101660 Tesh, J.; Ross, F.; Earthy, M. (1977) Abate®: Effects of Topical Application upon Pregnancy in the Rabbit: LSR Report No. 77/CY14/314. (Unpublished study received May 14, 1982 under 241- 220; prepared by Life Science Research, Eng., submitted by American Cyanamid Co., Princeton, NJ; CDL:247537-L).

00029530 McCann, J.A. (1971) [Abate® 2-G (Powder): Toxicity to Bluegill]: Test No. 352. (U.S. Agricultural Research Service, Pesticides Regulation Div., Animal Biology Laboratory, unpublished report).

00029533 McCann, J.A. (1971) [Abate® 4E: Toxicity to Bluegill]: Test No. 357. (U.S. Agricultural Research Service, Pesticides Regulation Div., Animal Biology Laboratory, unpublished report).

00029534 McCann, J.A. (1971) [Abate® 4-E: Toxicity to Rainbow Trout]: Test No. 414. (U.S. Agricultural Research Service, Pesticides Regulation Div., Animal Biology Laboratory, unpublished report).

00029532 McCann, J.A. (1971) [Abate® 4E: Toxicity to Rainbow Trout]: Test No. 408. (U.S. Agricultural Research Service, Pesticides Regulation Div., Animal Biology Laboratory, unpublished report).

00052129 McCann, J.A.; Pitcher, F.G. (1975) Riverdale 5%: Toxicity to Daphnia magna: Test No. 840. (U.S. Environmental Protection Agency, Chemical & Biological Investigations Branch, TSD, un- published study).

00052130 McCann, J.A.; Pitcher, F.G. (1975) Riverside 5%: Toxicity to Daphnia magna: Test No. 836. (U.S. Environmental Protection Agency, Chemical & Biological Investigations Branch, TSD, un-published study).

00157841 Fletcher, D. (1986) Acute Oral Toxicity Study with Temephos Technical in Bobwhite Quail: Study No. 85 QD 64. Unpublished study prepared by Bio-Life Associates, Ltd. 29 p.

00158327 Forbis, A.;Frazier, S. (1986) Acute Toxicity of Abate® 4E to Daphnia magna: Static Acute Toxicity Report #34343. Unpublished study prepared by Analytical Biochemistry Labs., Inc. 43 p.

00161090 Dose, E. (1986) Acute Toxicity of Abate® 4E to the Pink Shrimp (Penaeus duorarum) under Flow-through Conditions: Toxicity Test Report: ESE No. 86-315-0200-2130: Cyanamid Protocol No. 981-86-115. Unpublished study prepared by Environmental Science and Engineering, Inc. 35 p.

00161091 Dose, E. (1986) Acute Toxicity of Abate® 4-E Insecticide on Shell Growth of the Eastern Oyster (Crassostrea virginica): Toxicity Test Report: ESE No. 86-315-0100-2130: Cyanamid Protocol No. 981-86-117. Unpublished study prepared by Environmental Science and Engineering, Inc. 37 p.

00165027 Fung, C. (1986) Abate® Insecticide, Temephos (CL 52,160): Metabolic Fate of Abate® Insecticide in Bluegill Sunfish (Lepomis macrochirus): Project No. 0112: Report No. PD-M Volume 23-37. Unpublished study prepared by American Cyanamid Co. 21 p.

05000638 Pasarela, N.R.; Orloski, E.J. (1973) Abate® insecticide. Pages 119-146, In Analytical Methods for Pesticides and Plant Growth Regulators. Edited by G. Zweig. Vol. VII. Thin-layer and Liquid Chromatography. Pesticides of International Importance. Edited by J. Sherma and G. Zweig. New York: Academic Press.

05002680 Umino, T.; Suzuki, T. (1969) [Effect of two new insecticides, Abate® and Dursban, on larvae and adults of mosquitos.] Eisei Dobutsu. [Sanitary Zoology.] 20(2):95-99.

40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and Data Base for 410 Chemicals and 66 Species of Freshwater Animals. US Fish & Wildlife Service, Resource Publication 160. 579p.

GS0006001 American Cyanamid Company (1978) Abate® Technical Insecticide. (Letter from J. Robt Gray to Marilyn Mautz, Registration Division, EPA under 241-220; submitted by American Cyanamid Co., Princeton, N.J.

GS0006002 Zee, K.T. (1971) Method Trail for Abate® and Abate® Sulfoxide on Cotton Seed (Unpublished study received 1971 under )F0913).

Note: Lee County Mosquito Control District in Fort Myers, FL submitted additional studies that were of significant help for the Agency in characterizing the risks of temephos although they were not guideline studies and are not included in this bibliography. Reviews of these studies are available in the public docket.

Appendix E. GENERIC DATA CALL-IN

See attached table for a list of generic data requirements. Note that a complete Data Call-In (DCI), with all pertinent instructions, is being sent to registrants under separate cover.

Appendix F. PRODUCT SPECIFIC DATA CALL-IN

See attached table for a list of product-specific data requirements. Note that a complete Product Specific Data Call-In (PDCI), with all pertinent instructions, is being sent to registrants under separate cover.

Appendix G. EPA'S BATCHING OF TEMEPHOS PRODUCTS FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION

In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data requirements for reregistration of products containing TEMEPHOS as the active ingredient, the Agency has batched products which can be considered similar for purposes of acute toxicity. Factors considered in the sorting process include each product's active and inert ingredients (identity, percent composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since some products within a batch may not be considered chemically similar or have identical use patterns.

Using available information, batching has been accomplished by the process described in the preceding paragraph. Not-with-standing the batching process, the Agency reserves the right to require, at any time, acute toxicity data for an individual product should the need arise.

Registrants of products within a batch may choose to cooperatively generate, submit or cite a single battery of six acute toxicological studies to represent all the products within that batch. It is the registrants' option to participate in the process with all other registrants, only some of the other registrants, or only their own products within a batch, or to generate all the required acute toxicological studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she must use one of the products within the batch as the test material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the data base is complete and valid by today's standards (see acceptance criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not been significantly altered since submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data is referenced, registrants must clearly identify the test material by EPA Registration Number. If more than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the formulation actually tested by identifying the corresponding CSF.

In deciding how to meet the product specific data requirements, registrants must follow the directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice contains two response forms which are to be completed and submitted to the Agency within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data requirements for each product. The second form, "Requirements Status and Registrant's Response," lists the product specific data required for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend on someone else to do so. If a registrant supplies the data to support a batch of products, he/she must select one of the following options: Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies.

Twenty two products were found which contain temephos as the active ingredient. These products have been placed into seven batches and a "no batch" category in accordance with the active and inert ingredients and type of formulation. The following bridging strategies may be employed:

NOTE: The technical acute toxicity values included in this document are for informational purposes only. The data supporting these values may or may not meet the current acceptance criteria.

Appendix G. EPA'S BATCHING OF TEMEPHOS PRODUCTS FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION

Batch

EPA Reg. No.

% Active Ingredient

Formulation Type

1

8329-56

Temephos...90.0%

liquid/emulsifiable concentrate

Batch

EPA Reg. No.

% Active Ingredient

Formulation Type

2

66733-9

Temephos...45.1%

liquid/emulsifiable concentrate

769-678

Temephos...43.0%

solid/granular

48273-10

Temephos...43.0%

solid/granular

228-122

Temephos...43.0%

solid/granular

Batch

EPA Reg. No.

% Active Ingredient

Formulation Type

3

8329-15

Temephos...5.0%

solid/granular
 

8329-30

Temephos...5.0%

solid/granular
 

769-722

Temephos...5.0%

solid/granular

Batch

EPA Reg. No.

% Active Ingredient

Formulation Type

3A

8329-59

Temephos...5.0%

solid/granular
 

228-118

Temephos...5.0%

solid/granular

Batch

EPA Reg. No.

% Active Ingredient

Formulation Type

4

769-725

Temephos...2.0%

solid/granular
 

769-723

Temephos...1.0%

solid/granular
 

8329-57

Temephos...1.0%

solid/granular
 

8329-17

Temephos...1.0%

solid/granular
 

48273-9

Temephos...1.0%

solid/granular

Batch

EPA Reg. No.

% Active Ingredient

Formulation Type

5

8329-58

Temephos...2.0%

solid/granular
 

8329-16

Temephos...2.0%

solid/granular
 

769-724

Temephos...1.0%

solid/granular
 

228-121

Temephos...2.0%

solid/granular

Batch

EPA Reg. No.

% Active Ingredient

Formulation Type

6

66733-11

Temephos...2.0%

solid/granular

66733-10

Temephos...1.0%

solid/granular

228-107

Temephos...1.0%

solid/granular

Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN

See attached table for a list of registrants sent the DCI and PDCI. Note that a complete Data Call-In (DCI) and Product Specific Data Call-In (PDCI), with all pertinent instructions, is being sent to registrants under separate cover.

Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND ELECTRONICALLY AVAILABLE FORMS

Pesticide Registration Forms are available at the following EPA Internet site:

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

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)

Instructions

1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on your computer then printed.)

2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.

3. Mail the forms, along with any additional documents necessary to comply with EPA regulations covering your request, to the address below for the Document Processing Desk.

DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive Information.'

If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or by e-mail at williams.nicole@epamail.epa.gov.

The following Agency Pesticide Registration Forms are currently available via the Internet at the following locations:

8570-1

Application for Pesticide Registration/Amendment

https://www.epa.gov/opprd001/forms/8570-1.pdf

8570-4

Confidential Statement of Formula

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

8570-5

Notice of Supplemental Registration of Distribution of a Registered Pesticide Product

https://www.epa.gov/opprd001/forms/8570-5.pdf

8570-17

Application for an Experimental Use Permit

https://www.epa.gov/opprd001/forms/8570-17.pdf

8570-25

Application for/Notification of State Registration of a Pesticide To Meet a Special Local Need

https://www.epa.gov/opprd001/forms/8570-25.pdf

8570-27

Formulator's Exemption Statement

https://www.epa.gov/opprd001/forms/8570-27.pdf

8570-28

Certification of Compliance with Data Gap Procedures

https://www.epa.gov/opprd001/forms/8570-28.pdf

8570-30

Pesticide Registration Maintenance Fee Filing

https://www.epa.gov/opprd001/forms/8570-30.pdf

8570-32

Certification of Attempt to Enter into an Agreement with other Registrants for Development of Data

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

8570-34

Certification with Respect to Citations of Data (in PR Notice 98-5)

https://www.epa.gov/pesticides/PR_Notices/pr98-5.pdf

8570-35

Data Matrix (in PR Notice 98-5)

https://www.epa.gov/pesticides/PR_Notices/pr98-5.pdf

8570-36

Summary of the Physical/Chemical Properties (in PR Notice 98-1)

https://www.epa.gov/pesticides/PR_Notices/pr98-1.pdf

8570-37

Self-Certification Statement for the Physical/Chemical Properties (in PR Notice 98-1)

https://www.epa.gov/pesticides/PR_Notices/pr98-1.pdf

Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/

Dear Registrant:

For your convenience, we have assembled an online registration kit which contains the following pertinent forms and information needed to register a pesticide product with the U.S. Environmental Protection Agency's Office of Pesticide Programs (OPP):

1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.

2. Pesticide Registration (PR) Notices

a. 83-3 Label Improvement Program--Storage and Disposal Statements

b. 84-1 Clarification of Label Improvement Program

c. 86-5 Standard Format for Data Submitted under FIFRA

d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems (Chemigation)

e. 87-6 Inert Ingredients in Pesticide Products Policy Statement

f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement

g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments

h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in PDF format and requires the Acrobat reader.)

Other PR Notices can be found at https://www.epa.gov/pesticides/PR_Notices

3. Pesticide Product Registration Application Forms (These forms are in PDF format and will require the Acrobat reader.)

a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment

b. EPA Form No. 8570-4, Confidential Statement of Formula

c. EPA Form No. 8570-27, Formulator's Exemption Statement

d. EPA Form No. 8570-34, Certification with Respect to Citations of Data

e. EPA Form No. 8570-35, Data Matrix

4. General Pesticide Information (Some of these forms are in PDF format and will require the Acrobat reader.)

a. Registration Division Personnel Contact List

d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF format)

e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)

f.. 40 CFR Part 158, Data Requirements for Registration (PDF format)

g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)

Before submitting your application for registration, you may wish to consult some additional sources of information. These include:

1. The Office of Pesticide Programs' Web Site

2. The booklet "General Information on Applying for Registration of Pesticides in the United States", PB92-221811, available through the National Technical Information Service (NTIS) at the following address:

National Technical Information Service (NTIS)

5285 Port Royal Road

Springfield, VA 22161

The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the process of updating this booklet to reflect the changes in the registration program resulting from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We anticipate that this publication will become available during the Fall of 1998.

3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for Environmental and Regulatory Information Systems. This service does charge a fee for subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or through their Web site.

4. The National Pesticide Telecommunications Network (NPTN) can provide information on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at (800) 858-7378 or through their Web site: ace.orst.edu/info/nptn.

The Agency will return a notice of receipt of an application for registration or amended registration, experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his submission a stamped, self-addressed postcard. The postcard must contain the following entries to be completed by OPP:

Date of receipt

EPA identifying number

Product Manager assignment

Other identifying information may be included by the applicant to link the acknowledgment of receipt to the specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying File Symbol or petition number for the new submission. The identifying number should be used whenever you contact the Agency concerning an application for registration, experimental use permit, or tolerance petition.

To assist us in ensuring that all data you have submitted for the chemical are properly coded and assigned to your company, please include a list of all synonyms, common and trade names, company experimental codes, and other names which identify the chemical (including "blind" codes used when a sample was submitted for testing by commercial or academic facilities). Please provide a CAS number if one has been assigned.

1. The 21-day dermal toxicity study in the rat with interim ChE measurements would be used to address three guidelines-"Neurotoxicity Screening Battery-Acute" (870.6200 / 81-8), "21-Day Dermal" (82-2), and "90-Day Neurotoxicity" (82-5 (b)).

2. The developmental (teratogenicity) study in a second species may be required depending on the outcome of the 21-day dermal study. Because temephos has no food uses, this study may be waived if data demonstrate low potential for exposure.

3. PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.

4. PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.

pesticides/reregistration/REDs/temephosappend.htm

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