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GUIDE TO APPENDIX C
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.
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unpublished materials submitted to the Agency, the Agency has sought to identify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.
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.
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 labora'tory or testing facility as the
author. When no author or laboratory could be identified, the Agency has
shown the first submitter as the author.
131
-------
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 (19??), the Agency was unable to determine or estimate the date
of the document. ,
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.
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. .
132
-------
BIBLIOGRAPHY
MRID
CITATION
00005918 Hegdal, P.L.; Gatz, T.A.; (1977) Hazards to Pheasants and Cottontail
Rabbits Associated with Zinc phosphide Baiting for Microtine Rodents in
Orchards. (Unpublished study received Jan 31, 1978 under 12455-17;
prepared by U.S. Fish and wildlife Service, Denver Wildlife Research
Center, submitted by Bell Laboratories, Madison, Wis.; CDL:232996-A)
00005921 Hawaii. Department of Agriculture (1970?) Preparation of Pure Phosphine
Gas and Notes on the Analysis of Phosphine in Closed Systems. Undated
method. (Unpublished study received Mar 3, 1971 under OF0890;
CDL:093187-D)
00005922 Robinson, W.H.; Hilton, H;W.; Mee, J.; Uyehara, G. (1968) Methodology:
Determination of Phosphine Residues in Sugarcane and Related Sugar
Products from the Use of Zinc phosphide. Includes undated method.
(Unpublished study received Sep 25, 1969 under OF0890; prepared by U.S.
Fish and Wildlife Service, Denver Wildlife Research Center, Section of
Chemical Research and Analytical Activities in cooperation with Hawaiian
Sugar Planters' Association, Experiment Station, submitted by Hawaii,
Dept. of Agriculture, Honolulu, Hawaii; CDL:093187-F)
00005923 Hawaii. Department of Agriculture (1969) Laboratory Evaluation of Zinc
phosphide Toxicity and Bait Formulations. (Unpublished study received Sep
25, 1969 under OF0890; CDL:093187-H) -
00005924 Hawaii, Department of Agriculture (1966?) Physical and Chemical
Properties of Technical Zinc phosphide. Summary of studies 093187-V and
093187-Z through 093187-AB. (Unpublished study received Sep 25, 1969,
under OF0890; CDL:093187-I)
00005925 Hawaii. Department of Agriculture (19??) Residue Reduction in Phosphine
and Zinc phosphide. (Unpublished study received Sep 25, 1969 under
OF0890; CDL:093187-J)
00005926 U.S. Fish and Wildlife Service, Denver Wildlife Research Center (1969)
Rate of Hydrolysis of Zinc phosphide. (Unpublished study including
comments by W.H. Robinson, received Sep 25, 1969 under OF0890;
submitted by Hawaii, Dept. of Agriculture, Honolulu, Hawaii;
CDL:093187-K)
133
-------
BIBLIOGRAPHY
MRID
CITATION
00005927 National Pest Control Association (1967) Technical Release: Zinc
phosphide: No. 17-67. (Unpublished study received Sep 25, 1969 under
OF0890; submitted by Hawaii, Dept. of Agriculture, Honolulu, Hawaii;
CDL:093187-M)
00005928 Association of American Pesticide Control Officials, Incorporated (1966)
Pesticide Chemicals Official Compendium, (pp. 1242-1243 only; available
from: The Treasurer, Robert H. Guntert, Director, Control Div., Kansas
State Board of Agriculture, 1032-S State Office Building, Topeka, Ks
66606; unpublished study received Sep 25, 1969 under OF0890; submitted
by Hawaii, Dept. of Agriculture, Honolulu, Hawaii; CDL:093187-O)
00005929 Van Wazer, J.R. (1958) Elemental phosphorus and the metal phosphides.
Pages 122-177,InPhosphorus and Its Compounds: Volume I. By author.
New York: N.Y. Interscience Publishers. (Also In unpublished submission
received Sep 25, 1969 under OF0890; submitted by Hawaii, Dept. of
Agriculture, Honolulu, Hawaii; CDL:093187-P)
00005930 Van Wazer, J.R. (1958) Hydrides, halides, and pseudohalides of phosphorus
and their organic derivatives. Pages 179-219,In Phosphorus and Its
Compounds: Volume 1. By author. New York: N.Y. Interscience
Publishers. (Also In unpublished submission received Sep 25, 1969 under .
OF0890; submitted by Hawaii, Dept. of Agriculture, Honolulu, Hawaii;
CDL:093187-Q)
00005931 Hilton, H.W. (1966) Pesticides and food additives in sugarcane and sugar
products. Pages l-30,InResidue Reviews: Volume 15. Edited by F.A.
Gunther. New York: Springer-Verlag. (Alsoln unpublished submission
received Sep 25, 1969 under OF0890; .submitted by Hawaii, Dept. of
Agriculture, Honolulu, Hawaii; CDL:093187-R)
00005932 U.S. Fish and Wildlife Service (1959) Characteristics of Common
Rodenticides. Rev. Washington, D.C.: U.S. Dept. of Interior. (Wildlife
leaflet 337; alsolnunpublished submission received Sep 25, 1969 under
OF0890; submitted by Hawaii, Dept. of Agriculture, Honolulu, Hawaii;
CDL:093187-S)
134
-------
BIBLIOGRAPHY
MRID
CITATION
00005933 Syracuse, M.G. (1965?) Zinc phosphide: Phbsphine. (Unpublished study
received Sep 25, 1969 under OF0890; submitted by Hawaii, Dept. of
Agriculture, Honolulu, Hawaii; CDL:093187-T)
00005936 Robison, W.H. (1969) Determination of Phosphine Residue from Sugar
Cane. Method dated Jul 24, 1969. (Unpublished study received Sep 25,
1969 under OF0890; prepared by U.S. Fish and Wildlife Service, Denver
' Wildlife Research Center, submitted by Hawaii, Dept. of Agriculture,
Honolulu, Hawaii; CDL:093187-X) ' } .
00005938 Hayne, D.W. (1951) Zinc phosphide: Its toxicity to pheasants and effect of.
weathering upon its toxicity to mice: Michigan Agricultural Experiment
Station Quarterly Bulletin 33(4):412-425. (Alsoln unpublished submission
received Sep 25, 1969.under OF0890; submitted by Hawaii, Dept. of
Agriculture, Honolulu, Hawaii; CDL:093187-AA)
00005939 Elmore, J.W.; Roth, F.J. (1943) Analysis and stability of Zinc phosphide.
Journal of the Association of Official Agricultural Chemists
XXVI(4):559-564. (Alsoln unpublished submission received Sep 25, 1969
under OF0890; submitted by Hawaii, Dept. of Agriculture, Honolulu,
Hawaii; CDL:093187-AB)
00005940 Hawaii. Department of Agriculture (1965?) Residue Data for Zinc phosphide
and Phosphine. (Unpublished study received Sep 25, 1969 under OF0890;
CDL:093187-AD)
00005941 National Pest Control Association (1968).Technical Release: Research
Report on the Stability of Zinc phosphide: No. 14-68. (Unpublished study
received Sep 25, 1969 under OF0890; submitted by Hawaii, Dept. of
Agriculture, Honolulu, Hawaii; CDL: 093187-AE)
00005947 Hawaii. Department of Agriculture (1967) Toxicity of Zinc phosphide.
(Unpublished study received Mar 3, 1971 under OF0890; prepared in
cooperation with U.S. Fish and Wildlife Service, Denver Wildlife Research
" Center; CDL:093186-E)
00005948 Robison, W.H. (1969) Results of Residue Analysis of Sugarcane for
Phosphine. (Unpublished study received Mar 3, .1971 under OF0890;
135
-------
BIBLIOGRAPHY
MRID
CITATION
prepared by U.S. Fish and Wildlife Service, submitted by Hawaii, Dept. of
Agriculture, Honolulu, Hawaii; CDL:093186-G)
00005949 Hawaii. Department of Agriculture (1969) Studies with Radioactive
Phosphine-Has3->32P. (Unpublished study received Mar 3, 1971 under
OF0890; CDL:093186-H)
00005950 U.S. Fish and Wildlife Service (1972) Control of Black-Tailed Prairie Dogs
in the Western United States: Problem Analysis. Summary of studies
091945-D through 091945-R. (Unpublished study received Apr 15, 1974
under 4F1494; submitted by U.S. Dept. of Interior, Fish and Wildlife
Service, Washington, D.C.; CDL:091945-A)
00005951 U.S. Fish and Wildlife Service (1952?) Laboratory Evaluations of Zinc
phosphide. (Unpublished study received Apr 15, 1974 under 4F1494;
submitted by U.S. Dept. of Interior, Fish and Wildlife Service, Washington,
D.C.; CDL:091945-B)
00005952 U.S. Fish and Wildlife Service (1973) Field Evaluations of Zinc phosphide.
(Unpublished study received Apr 15, 1974 under 4F1494; submitted by U.S.
Dept. of Interior, Fish and Wildlife Service, Washington, D.C.;
CDL:091945-C)
00005962 U.S. Fish and Wildlife Service (1974) Black-Tailed Prairie Dog: Occurence
and Range. (Unpublished study received on unknown date under 4F1494;
submitted by U.S. Dept. of Interior, Fish and Wildlife Service, Washington,
D.C.; CDL:093969-A)
00005965 Lewis, J.C.; Hassien, F. (1973) Status of Prairie Dogs and Surveys for
Black-Footed Ferrets in Oklahoma. (Unpublished study received on
unknown date under 4F1494; prepared by Oklahoma, Cooperative Wildlife
Research Unit, submitted by U.S. Dept. of Interior, Fish and Wildlife
Service, Washington, D.C.; CDL: 093969-H)
00005968 Scheelhaase, C.G. (1972) Status of the Prairie Dog in Saskatchewan.
(Unpublished study received on unknown date under 4F1494; prepared by
Saskatchewan, Dept. of Natural Resources, submitted by U.S. Dept. of
Interior, Fish and Wildlife Service, Washington, D.C.; CDL:093969-M)
136
-------
BIBLIOGRAPHY
MRID
CITATION
00005969 Van Ballenberghe, V.; Berryman, J.H.; Johnson, N.G. (1973) Ferret and
Prarie Dog Programs on Public Lands. (Unpublished study received on
unknown date under 4F1494; prepared by Div. of Wildlife Services, Branch
of Animal Damage Control, in cooperation with South Dakota State Univ.,
submitted by U.S. Dept. of Interior, Fish and Wildlife Service, Washington,
D.C.; CDL: 093969-N)
00005970 Robinson, L.D. (1969?) Black-Footed Ferret and Prairie Dog Programs on
Forest Service Administered Lands. (Unpublished study received on
unknown date under 4F1494; prepared by U.S. Forest Service, Nebraska
National Forest, submitted by U.S. Dept. of Interior, Fish and Wildlife
Service, Washington, D.C.; CDL: 093969-O) , . .
( - ' t _
00005999 Stephenson, J.B.P. (1967) Zinc phosphide poisoning. Archives of
Environmental Health 15(?/Jul):83-88. (Also In unpublished submission ,
received Apr 23, 1976 under 6704-78; submitted .by U.S. Dept. of Interior,
Fish and Wildlife Service, Washington, D.C.; CDL:224029-B)
00006025 U.S..Fish and Wildlife Service (1977) A Zinc phosphide Dietary LC50
Study against Bobwhite Quail and Mallard Ducks. (Unpublished study
- received Jul 15, 1977 under 6704-78; submitted by U.S. Dept. of Interior,
' Fish and Wildlife Service, Washington, D.C.; CDL:230884-A)
•' - ' . • . • ' \ • • . •
00006028 Piccirillo, V.J. (1977) Final Report: Acute Eye Irritation Potential Study in
Rabbits: Project No. 419-134. (Unpublished study received Apr 12, 1977
under 6704-78; prepared by Hazleton Laboratories America, Inc., submitted
. . • / by U.S. Dept. of Interior, Fish and Wildlife Service, Washington, D.C.;
CDL:229306-B) ,
00006029 Piccirillo, V.J. (1977) Final Report: Primary Skin Irritation Study in
Rabbits: Project No. 419-134. (Unpublished study received Apr 12, 1977
under 6704-78; prepared by Hazleton Laboratories America, Inc., submitted
by U.S. Dept. of Interior, Fish and Wildlife Service, Washington, D.C.;
CDL-229306-C)
137
-------
BIBLIOGRAPHY
MRID
CITATION
\
00006030 Piccirillo, V.J. (1977) Final Report: Acute Dermal Toxicity Study in
Rabbits: Project No. 419-134. (Unpublished study received Apr 12, 1977
under 6704-78; prepared by Hazleton Laboratories America, Inc., submitted
by U.S. Dept. of Interior, Fish and Wildlife Service, Washington, D.C.;
CDL:229306-D)
00006031 Matschke, G.H. (1978) A Zinc phosphide Dietary LC50 Study against
Bobwhite Quail. (Unpublished study received Mar 28, 1978 under 6704-78;
submitted by U.S. Dept. of Interior, Fish and Wildlife Service, Washington,
D.C.; CDL:233339-A)
00006032 Matschke, G.H.; Higgins, W.H. (1978) Adult Bobwhite Quail LD50 and 95
Percent Confidence Limits. (Unpublished study received Mar 15, 1978
under 6704-78; submitted by U.S. Dept. of Interior, Fish and Wildlife
Service, Washington, D.C.; CDL:233244-A)
00006033 Matschke, G.H.; Higgins, W.H. (1978) Adult Mallard Duck LD50 and 95
Percent Confidence Limits. (Unpublished study received Mar 15, 1978
under 6704-78; submitted by U.S. Dept. of Interior, Fish and Wildlife
Service, Washington, D.C.; CDL:233243-A)
00006044 Lisk, D.J.; Smith, W.G.; Gutenmann, W. (1973) Phosphine Residues in
Grapes Resulting from Vineyard Treatment with Zinc phosphide.
(Unpublished study including letter dated Jul 11, 1974 from D.J. Lisk to
Richard Guest, received Sep 20, 1974 under 5E1551; prepared by Cornell
Univ., Food Science Dept., Pesticide Residue Laboratory; submitted by
Interregional Research Project No. 4, New Brunswick, N.J.;
CDL:094602-C)
00006045 Dewey, I.E. (1974) 2% Zinc phosphide-Treated Cracked Corn for Mouse
Control in Vineyards. (Unpublished study including letter dated Oct 18,
1972 from I.E. Dewey to Charlie C. Compton, received Sep 20, 1974 under
5E1551; prepared by Cornell Univ., Cooperative Extension,
Chemicals-Pesticides Programs, submitted by Interregional Research Project
No. 4, New Brunswick, N.J.; CDL: 094602-D)
138
-------
BIBLIOGRAPHY
MRID
CITATION
00006047
00006058
00019919
00029247
00068028
00082533
00082535
Hilton, H.W.; Pank, L.F.; Teshima, A.H. (1972) Progress Report on Two
Years of Rat Control with Zinc phosphide Bait. (Technical supplement to
.insect and rat control report 24; unpublished study received Apr 16, 1973
under 10646-1; submitted by Hawaii, Dept. of Agriculture, Honolulu,
Hawaii; CDL:005036-B)
Hilton, H.W.; Robison, W.H.; Teshima, A.H. (1971) Fate of Zinc
Phosphide and Phosphine in or near Sugarcane Fields. Includes undated
method. (Unpublished study including 22 letters dated Jul 19, 1968 from
H.W. Hilton to Plantation Agriculturalists, received Mar 3, 1971 under
OF0890; prepared by Hawaiian Sugar Planters' Association in cooperation
with U.S. Dept. of Interior, Denver Wildlife Research Center, submitted by
Hawaii, Dept. of Agriculture, Honolulu, Hawaii; CDL:093187-A)
Hawaii. Department of Agriculture (1963) Zinc Phosphide-Data Sheet No.
809. (Unpublished study received Sep 25, 1969 under OF0890;
CDL:093187-L)
Piccirillo, V.J. (1977) Final Report: Acute Eye Irritation Potential Study in
Rabbits: Project No. 419-134. (Unpublished study received Jan 7, 1980
under 12455-24; prepared by Hazleton Laboratories America, Inc.,
submitted by Bell Laboratories, Madison, Wis.; CDL:241618-C)
Hilton, H.W.; Robison, W.H. (1972) Fate of zinc phosphide and phosphine
in the soil-water environment. Journal of Agricultural and Food Chemistry
20(6): 1209-1214. (Also In unpublished submission received May 8, 1981
under HI 80/9; submitted by state of Hawaii for an unknown registrant;
CDL-.245041-C)
Hooker Chemical Company (1963) Zinc Phosphide: Data Sheet No. 809.
(Unpublished study received May 10, 1974 under 4F1494; submitted by
U.S. Fish and Wildlife Service, Washington, D.C.; CDL: 093967-E)
National Pest Control Association (1967) Zinc Phosphide. Elizabeth, N.J.:
NPCA. (Technical release no. 17-67; alsolnunpublished submission
received May 10, 1974 under 4F1494; submitted by U.S. Fish and Wildlife
Service, Washington, D. C.; CDL: 093967-H)
139
-------
BIBLIOGRAPHY
MRID
CITATION
00082538 Syracuse, M.G. (1965) Zinc Phosphide (Phosphine). (Unpublished study
received May 10, 1974 under 4F1494; submitted by U.S. Fish and Wildlife
Service, Washington, D.C.; CDL:093967-L)
00082540 Brock, E.M. (1965) Toxicological feeding trials to evaluate the hazard of
secondary poisoning to gopher snakes (Pituophincatenifer). Copeia
2:244-245. (Also In unpublished submission received May 10, 1974 under
4F1494; submitted by U.S. Fish and Wildlife Service, Washington, D.C.;
CDL:093967-N)
00082541 Chitty, D., ed. (1954) Control of Rats and Mice: Volume 1. ?: Oxford
Univ. Press. (Pages 102,106-108 only; alsolnunpublished submission
received May 10, 1974 under 4F1494; submitted by U.S. Fish and Wildlife
Service, Washington, D.C.; CDL: 093967-O)
00082542 Doty, R.E. (1945) Rat control on Hawaiian sugar-cane plantations. Hawaiian
Planters' Record 49(2):71-239; Taken from: Chemical Abstracts
40:1276-1277. (Also In unpublished submission received May 10, 1974
under 4F1494; submitted by U.S. Fish and Wildlife Service, Washington,
D.C.; CDL:093967-P) '
00082550 Schoof, H.F. (1970) Zinc phosphide as a rodenticide. Pest Control
?(May):38,42-44. (Also In unpublished submission received May 10, 1974
under 4F1494; submitted by U.S. Fish and Wildlife Service, Washington,
D.C.; CDL:093967-AC)
00082553 Hilton, H.W.; Robison, W.H.; Teshima, A.H.; et al. (1972) Zinc phosphide
as a rodenticide for rats in Hawaiian sugarcane. Pages
561-570,InProceedings, 14th Congress, International Society of Sugar Cane
Technologists; Nov 1971, New Orleans, Louisiana. By? N.P.
(Alsolnunpublished submission received May 10, 1974 under 4F1494;
submitted by U.S. Fish and Wildlife Service, Washington, D.C.;
CDL:093967-AP)
140
-------
BIBLIOGRAPHY
MRID
CITATION
00085366 Ashton, A.D.; Jackson, W.B. (1981) Letter sent to George Miller dated Jul
27, 1981: Acute oral LD50 testing with zinc phosphide (4966-78-C):
Preliminary draft. (Unpublished study receive'd Aug 11, 1981 under 935-28;
prepared by Bowling Green State Univ., Center for Environmental Research
and Services, submitted by Hooker Chemical & Plastics Corp., Niagara
Falls, N.Y.;'CDL:245763-C)
00151407 Hill, E.; Carpenter, J. (1982) Responses of Siberian ferrets to secondary
zinc phosphide poisoning. J. Wildl. Manage.-46(3): 678-685.
05007610 Okuno, I.; Wilson, R.A.; White, R.E. (1975) Determination of zinc
phosphide in range vegetation by gas chromatography. Bulletin of
Environmental Contamination and Toxicology 13(4);392-396.
05007787 Hilton, H.W.; Mee, J.M.L. (1972) Studies with radioactive
; phosphine-->32P in sugarcane. Journal of Agricultural and Food Chemistry
20(2):334-336.
40962501 Markle, G. (1988) Zinc Phosphide Magnitude of Residue on Artichoke: IR-4
PR 1765. Unpublished compilation prepared by Univ. of California, Davis,
IR-4 Western Region Analytical Laboratory. 23 p.
41035001 Biehn, W. (1989) Zinc Phosphide: .Magnitude of Residue on Sugar Beet:
Project ID: IR-4 PR No. 1734. Unpublished study prepared by IR-4
Western Region Analytical Laboratory. 26, p.
41507401 Matschke, G.; Andrews, K. (1990) Zinc Phosphide: Black-Tailed Prairie
Dog—Domestics Ferret Secondary Poisoning Study: Lab Project Number:
902:1 -33. Unpublished study prepared by Denver Wildlife Research Center,
80 p.
42306201 Johnson, G. (1992) Primary and Secondary Hazards of Zinc Phosphide to
Nontarget Wildlife: A Review of the Literature: Lab Project Number:
QA-245. Unpublished study prepared by Western Ecosystems Technology,
Inc. 67 p.
141
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BIBLIOGRAPHY
MRID
CITATION
42986201 Asar, N. (1991) Zinc Phosphide Technical-(Ratol): Product Chemistry: Lab
Project Number: A: ZNP: 1: 91. Unpublished study prepared by United
Phosphorus Limited. 23 p.
42986202 Asar, N. (1991) Product Chemistry on Zinc Phosphide--Ratol: Physical and
Chemical Characteristics: Lab Project Number: UPL: EPA: ZNP: 91.
Unpublished study prepared by United Phosphorus Limited. 10 p.
42987301 San, R.; Wyman, M. (1993) Zinc Phosphide (Technical):
Salmonella/Mammalian-Microsome Plate Incorporation Mutagenicity Assay
(Ames Test): (Final Report): Lab Project Number: TD102.501: QA-273:
SPGT501. Unpublished study prepared by Microbiological Associates, Inc.
40 p.
42987302 Bigger, C.; Clarke, J. (1993) Zinc Phosphide (Technical): L5178Y
TK+/-Mouse Lymphoma Mutagenesis Assay: (Final Report): Lab Project
Number: TD102.701: QA-274: SPGT701. Unpublished study prepared by
Microbiological Associates, Inc. 36 p.
42987303 Putman, D.; Curry, P. (1993) Zinc Phosphide (Technical): Micronucleus
Cytogenetic Assay in Mice: (Final Report): Lab Project Number:
TD102.122: QA-275: SPGT122. Unpublished study prepared by
Microbiological Associates, Inc. 28 p.
43083501 Henwood, S. (1994) Developmental Toxicity Study with Zinc Phosphide in
Rats: Final Report: Lab Project Number: HWI 6451-100: QA-272.
Unpublished study prepared by Hazleton Wisconsin, Inc. 224 p.
43125501 Riekena, C. (1994) Series 61: Product Identity and Composition of
Technical Zinc Phosphide: Lab Project Number: BEL/0294/C140.
Unpublished study prepared by Bell Lab., Inc. 10 p.
43125502 Riekena, C. (1994) Series 62: Analysis and Certification of Product
Ingredients of Technical Zinc Phosphide: Lab Project Number:
BEL/0294/C140. Unpublished study prepared by Bell Lab., Inc. 30 p.
142'
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BIBLIOGRAPHY
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CITATION
43284301 Schaefer, G. (1994) Acute Neurotoxicity Study with Zinc Phosphide in Rats:
Lab Project Number: IRDG: 711/002., Unpublished study prepared by
IRDC. 742 p. -
43436601 Siglin, J. (1994) A 9.1 -Day Oral Toxicity Study in Rats with Zinc Phosphate
Technical: Final Report: Lab Project Numbers: 3294.1: QA-276: DWRC
QA-276. Unpublished study prepared by Springborn Labs, Inc. 528 p.
/ ~ , • -
43452401 Asar, N. (1994) Zinc Phosphide Technical--(Ratol): Product Chemistry: Lab
Project Number: A/ZNP/2/94. Unpublished study prepared by United
Phosphorus Ltd. 10 p.
43452402 Asar, N. (1994) Product Chemistry on Zinc Phosphide-Ratol: Lab Project
Number: UPL/EPA/ZNP/94. Unpublished study prepared by United
Phosphorus Ltd. 11 p.
43466302 Timm, R. (1994) Zinc Phosphide Technical: Environmental Fate--A Review
of the Literature. Unpublished study prepared by Denver Wildlife Research
Center. 38 p.
43466303 Timm, R. (1994) Zinc Phosphide Technical: Environmental Fate~A Review
of the Literature. Unpublished study prepared by Denver Wildlife Research
Center. 19 p.
43549801 Asar, N. (1994) Product Chemistry on Zinc Phosphide--(RATOL): Lab
Project Number; UPL:EPA:ZNP:1994. Unpublished study prepared by
United Phosphorus Ltd. 14 p.
43586602 Ramey, C.; Sterner, R.; Wolff, J.; et al. (1995) Observed Nontarget
Hazards to Ring-Necked Pheasants and California Quail of Broadcasting a
, 2 % Zinc Phosphide Oat Groats Bait for Control of Gray-Tailed Voles in
(QA-332): Lab Project Numbers: QA-332: 332. Unpublished study prepared
by Denver Wildlife Research Center. 515 p.
43903801 Schaefer, G. (1995) 13-Week Subchronic Neurotoxicity Study in Rats: Zinc
Phosphide Technical: Lab Project Number: 711-003: QA-396. Unpublished
study prepared by International Research and Development Corp. 800 p.
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CITATION
43903802
43932901
Schaefer, G. (1995) 13-Week Subchronic Neurotoxicity Study in Rats: Zinc
Phosphide Technical: Lab Project Number: 711-004: QA-396. Unpublished
stu.dy prepared by International Research and Development Corp. 551 p.
Leppert, B. (1996) Magnitude of Zinc Phosphide Residues in No-Till Corn:
Final Report: Lab Project Number: DWRC QA-428: SARS-95-60.
Unpublished study prepared by Stewart Agricultural Research Services, Inc
and USD A APHIS. 222 p.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
••'."' WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice^ the Data.Call-In Chemical
Status Sheet, to submit certain data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued
registration of your product(s) containing this active ingredient. Within 90 jlays after you
receive this Notice you must respond as set forth in Section III below. Your response must
state:
1 .N How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice
and in Attachment 3 (for both generic and product specific data), the
Requirements Status and Registrant's Response Form, (see section III-B); or
3. Why you believe EPA should not require your submission of data in the
manner specified by this Notice (see section III-D),
If you do not respond to this Notice, or if you do not satisfy EPA that you will
comply with its requirements or should be exempt or excused from doing so, then the
registration of your product(s) subject to this Notice will be subject to suspension. We have
provided a list of all of your products subject to this Notice in Attachment 2. All products
are listed on both the generic and product specific Data Call-In Response Fdrms. Also
included is a list of all registrants who were sent this Notice (Attachment 5).
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The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide,
Fungicide and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).
Collection of this information is authorized under the Paperwork Reduction Act by OMB
Approval No. 2070-0107 and 2070-0057 (expiration date 3-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The
Attachments contain specific chemical information and instructions. The six sections of the
Notice are:
Section I
Section II
Section III
Section IV
Section V
Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this Notice
Registrants' Obligation to Report Possible Unreasonable Adverse
Effects
Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In Response Forms
with Instructions (Form A)
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions (Form B)
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Citation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated
the data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the
continued use of products containing this active ingredient(s). You have been sent this
Notice because you "have product(s) containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
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The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements). Depending.on the results of the studies required in this Notice, additional
studies/testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in the Requirements Status and Registrant's Response Forms (Attachment 3)
within the timeframes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, VA. 22161
(Telephone number: 703-605-6000).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they, should be modified as appropriate so that
the data generated by the study will satisfy the requirements of 40 CFR § 158. Normally,
the Agency will not extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable standards. The OECD protocols
are available from OECD, 2001 L Street, N.W., Washington, D.C. 20036 (Telephone
number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY '
Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous Data Call-In(s), or any other agreements entered
into with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.
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SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to
this Notice. The type of Data Call-In you must comply with (Generic or Product Specific)
is specified in item number 3 on the four Data Call-In forms (Attachments 2 and 3).
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this
. Notice. Failure to adequately respond to this Notice within 90 days of your receipt will be
a basis for issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and
other bases for issuance of NOIS due to failure to comply with this Notice are presented in
Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to
satisfy the generic data requirements imposed by this Notice or (e) request a data
waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the generic data requirements of
this Notice is contained, in Section III-C. A discussion of options relating to requests for
data waivers is contained in Section III-D.
Two forms apply to generic data requirements, one or both of which must be used
in responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response
Form, (contained in Attachments 2 and 3, respectively).
The Data Call-In Response Forms must be submitted as part of every response to
this Notice. The Requirements Status and Registrant's Response Forms also must be
submitted if you do not qualify for a Generic Data Exemption or are not requesting
voluntary cancellation of your registration(s). Please note that the company's authorized
representative is required to sign the first page of both Data Call-In Response Forms and
the Requirements Status and Registrant's Response Forms (if this form is required) and
initial any subsequent pages. The forms contain separate detailed instructions on the
response options. Do not alter the printed material. If you have questions or need
assistance in preparing your response, call or write the contact person(s) identified in
Attachment 1.
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a. Voluntary Cancellation - .
You may avoid the requirements of this Notice by requesting voluntary cancellation
of your product(s) containing the active ingredient that is the subject of this Notice. If you
wish to voluntarily cancel your product, you must submit completed Generic and Product
Specific Data Call-In Response Forms (Attachment 2), indicating your election of this
option. Voluntary Cancellation is item number 5 on both Data Call-In Response Form(s). If
you choose this option, these are the only forms that you are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of
your product after the effective date of cancellation must be in accordance with the
Existing Stocks provisions of this Notice, which are contained in Section IV-C.
b.
Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your
product to which the requirements apply. If you wish to amend your registration to delete
uses, you must submit the Requirements Status and Registrant's Response Form
(Attachment 3), a completed application for amendment, a copy of your proposed amended
labeling, and all other information required for processing the application. Use deletion is
option number 7 under item 9 in the instructions for the Requirements Status and
Registrant's Response Forms. You must also Complete a Data Call-In Response Form by
signing the certification, item number 8. Application forms for amending registrations
may be obtained from the Registration Support Branch, Registration Division, Office of
Pesticide Programs, EPA, by calling (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to specific
data requirements, further sale, distribution, or use of your product after one year from the
due date of your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit'or cite generic data concerning an active ingredient
if the active ingredient in the product is derived exclusively from purchased, registered
pesticide products containing the active ingredient. EPA has concluded, as an exercise of
its discretion, that it normally will not suspend the registration of a product which would
qualify and continue to qualify for the generic data exemption in section 3(c)(2)(D) of
FIFRA. To qualify, all of the following requirements must be met:
(i). The active ingredient in your registered product must be present solely because
of incorporation of another registered product which contains the subject active
ingredient and is purchased from a source not connected with you;
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(ii). Every registrant who is the ultimate source of the active ingredient in your
product subject to this DCI must be in compliance with the requirements of this
Notice and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential
Statement of Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form, Attachment 2 and all supporting documentation. The Generic Data
Exemption is item number 6a on the Data Call-In Response Form. If you claim a generic
data exemption you are not required to complete the Requirements Status and Registrant's
Response Form. Generic Data Exemption cannot be selected as an option for responding to
product specific data requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other
persons to provide the Agency with the required data. If the registrant(s) who have
committed to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Data Call-in Notice, the Agency will
consider that both they and you are not compliance and will normally initiate proceedings
to suspend the registrations of both your and their product(s), unless you commit to submit
and do submit the required data within the specified time. In such cases the Agency
generally will not grant a time extension for submitting the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section III-C.l. of this Notice and comprise options
1 through 6 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form and item 6b on the Data Call-In Response Form. If you choose item 6b
(agree to satisfy the generic data requirements), you must submit the Data Call-In
Response Form and the Requirements Status and Registrant's Response Form as well as
any other information/data pertaining to the option chosen to address the data requirement.
Your response must be on the forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section III-D.l. of this Notice and are
covered by options 8 and 9 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit both
forms as well as any other information/data pertaining to the option chosen to address the
data requirement.
2. Product Specific Data Requirements
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The options for responding to this Notice for product specific data are: (a)
voluntary cancellation, (b) agree to satisfy the product specific data requirements imposed
by this Notice or (c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C. 2. A discussion of
options relating to requests for data waivers is contained in Section III-D.2.
Two forms apply to the product specific data requirements one or both of which
must be used in responding to the Agency, depending upon your .response. These forms
are the Data-Call-in Response Form, and the Requirements Status and Registrant's
Response Form, for product specific data (contained in Attachments 2 and 3, respectively)..
The Data Call-in Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form
also must be submitted for each product listed on the Data Call-In Response Form unless
the voluntary cancellation option is selected. Please note that the company's authorized
representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial
any subsequent pages. The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person(s) identified in Attachment 1.
a. Voluntary Cancellation '
You may avoid the requirements,of this Notice by requesting voluntary cancellation
of your product(s) containing the active ingredient that is the subject of this Notice. If you
wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item
number 5 on both the Generic and Product Specific Data Call-In Response Forms. If you
choose this option, you must complete both Data Call-In response forms. These are; the
only forms that you are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of ,
your product after the effective date of cancellation must be in accordance with the
Existing Stocks provisions of this Notice which are contained in Section IV-C.
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b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements
of this Notice. These options are discussed in Section III-C..of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements
Status and Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the
product specific data requirements for an MUP or EUP as applicable) on the product
specific Data Call-In Response Form. Note that the options available for addressing
product specific data requirements differ slightly from those options for fulfilling generic
data requirements. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements. It is important to ensure that you
are using the correct forms and instructions when completing your response to the
Reregistration Eligibility Decision document.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice
and are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose this option, you must submit the Data Call-In
Response Form and the Requirements Status and Registrant's Response Form as well as
any other information/data pertaining to the option chosen to address the data requirement.
Your response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1.
Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be
entered under item number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response Form. These six options are
listed immediately below with information in parentheses to guide you to additional
instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
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(4) I am submitting an existing study that has not been submitted previously to
the Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable Or an
existing study .that has been submitted but not reviewed by the Agency
(Citing an Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency
guidelines and with other Agency requirements as referenced herein and in the
attachments. All data generated and submitted must comply with the Good Laboratory
.Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
Assessment Guidelines (PAG) and be in conformance with the requirements of PR Notice
86-5. In addition, certain studies require Agency approval of test protocols in advance of
study initiation. Those studies for which a protocol must be submitted have been identified
in the Requirements Status and Registrant's Response Form and/or footnotes to the form.
If you wish to use a protocol which differs from the options discussed in Section II-C of
this Notice, you must submit a detailed description of the proposed protocol and your
reason for wishing to use it. The Agency may choose to reject a protocol not specified in
Section II-C. If the Agency rejects your protocol you will be notified in writing, however,
you should be aware that rejection of a proposed protocol will not be a basis for extending
the deadline for submission of data. . ,
A progress report must be submitted for each study within 90 days from the date
you are required to commit to generate or undertake some other means to address that
study requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study. This 90-day progress report must include the date the study was or
will be initiated and, for studies to be started within 12 months of commitment, the name
and address of the laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the
other information specified in the preceding paragraph, at a minimum, a brief description
of current activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the
registrant. If the data are not submitted by the deadline, each registrant is subject to receipt
of a Notice of Intent to Suspend the affected registration(s).
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If you cannot submit the data/reports to the Agency in the time required by this
Notice and intend to seek additional time to meet the requirements(s), you must submit a
request to the Agency which includes: (1) a detailed description of the expected difficulty
and (2) a proposed schedule including alternative dates for meeting such requirements on a
step-by-step basis. You must explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While EPA is considering your
request, the original deadline remains. The Agency will respond to your request in writing.
If EPA does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the expectation or
control of the registrant. Extensions will not be given in submitting the 90-day responses.
Extensions will not be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it is submitted at or after
the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the
required data but will not be submitting the data yourself, you must provide the name of
the registrant who will be submitting the data. You must also provide EPA with
documentary evidence that an agreement has been formed. Such evidence may be your
letter offering to join in an agreement and the other registrant's acceptance of your offer,
or a written statement by the parties that an agreement exists. The agreement to produce
the data need not specify all of the terms of the final arrangement between the parties or
the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot
resolve the terms of the agreement they may resolve their differences through binding
arbitration.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend
an existing agreement to meet the requirements of this Notice and have been unsuccessful,
you may request EPA (by selecting this option) to exercise its discretion not to suspend
your registration(s), although you did not comply with the data submission requirements of
this Notice. EPA has determined that as a general policy, absent other relevant
considerations, it will not suspend the registration of a product of a registrant who has in
good faith sought and continues to seek to enter into a joint data development/cost sharing
program, but the other registrant(s) developing the data has refused to accept the offer. To
qualify for this option, you must submit documentation to the Agency proving that you
have made an offer to another registrant (who has an obligation to submit data) to share in
the burden of developing that data. You must also submit to the Agency a completed EPA
Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 6. In addition, you must demonstrate that the other registrant to whom the
offer was made has not accepted your offer to enter into a cost-sharing agreement by
including a copy of your offer and proof of the other registrant's receipt of that offer (such
as a certified mail receipt). Your offer must, in addition to anything else, offer to share in
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the burden of producing the data upon terms to be agreed to or, failing agreement, to be
bound by binding arbitration as provided by FlFRA section 3(c)(2)(B)(iii) and must not
qualify this offer. The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-In Response
Form and a Requirements Status and Registrant's Response Form committing to develop
and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burden of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice. If the
other registrant fails to develop the data or for some other reason is subject to suspension,
your registration as well as that of the other registrant normally will be subject to initiation
of suspension proceedings, unless you commit to submit, and do submit, the required data
in the specified time frame. In such cases, the Agency generally will not grant a time
extension for submitting the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance .of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable,
the Agency will require you to comply with this Notice, normally without an extension of
the required date of submission. The Agency may determine at any time that a study is not
valid and needs to be repeated. ,
To meet the requirements of the DCI Notice for submitting an existing study, all of
the following three criteria must be clearly met:
a.
You must certify at the time that the existing study is submitted that the raw
data and specimens from the study are available for audit and review and you
must identify where they are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
Part 160. As stated in 40 CFR 160.3, Raw data means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for
the reconstruction and evaluation of the report of that study. In the event that
exact transcripts of raw data have been prepared (e.g., tapes which have
been transcribed verbatim, dated, and verified accurate by signature), the
exact copy or exact transcript may be substituted for the original source as
raw data. 'Raw data1 may include photographs,,microfilm or microfiche
copies, computer printouts, magnetic media, including dictated observations,
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b.
c.
and recorded data from automated instruments." The term "specimens",
according to 40 CFR 160.3, means "any material derived from a test system
for examination or analysis."
Health and safety studies completed after May 1984 must also contain all
GLP-required quality assurance and quality control information pursuant to
the requirements of 40 CFR Part 160. Registrants also must certify at the
time of submission of the existing study that such GLP information is
available for post May 1984 studies by including an appropriate statement on
or attached to the study signed by an authorized official or representative of
the registrant.
You must certify that each study fulfills the acceptance criteria for the
Guideline relevant to the study provided in the FIFRA Accelerated
Reregistration Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or meets
. the purpose of the PAG (both documents available from NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the
PAG are met by the study, clearly articulate the rationale why you believe
the study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and
that necessary raw data usually are not available for such studies.
If you submit an existing study, you must certify that the study meets all
requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were
addressed in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding
unreasonable adverse effects, you must notify the Agency of such a study. If such a study
is'in the Agency's files, you need only cite it along with the notification. If not in the
Agency's files, you must submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study
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If a study has been classified as partially acceptable and upgradeable, you may
submit data to upgrade that study. The Agency will review the data submitted and
determine if the requirement is satisfied. If the Agency decides the requirement is not
satisfied, you may still be required to submit new data normally without any time
extension. Deficient, but upgradeable studies will normally be classified as supplemental.
However, it is important to note that not all studies classified as supplemental are
upgradeable. If you have questions regarding the classification of a study or whether a
' study may be upgraded, call or write the contact person listed in Attachment 1. If you
submit data to upgrade an existing study you must satisfy or supply information to correct
all deficiencies in the study identified by EPA. You must provide a clearly articulated
rationale of how the deficiencies have been remedied or corrected and why the study
should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance
with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to
upgrade a study., but has not yet been reviewed by the Agency. You must provide the
MRID number of the data submission as well as the MRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply
to all data submissions intended to upgrade studies. Additionally, your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with
each of those criteria, as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies
If you choose to .cite a.study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable, or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have
been classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the
classification would be "acceptable." With respect to any studies for which you wish to
select this option, you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification
of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-34, Certification with Respect to Citation of
Data and EPA Form 8570-35 Data Matrix.
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2. Product Specific Data
If you acknowledge on the product specific Data Call-in Response Form that you
agree to satisfy the product specific data requirements (i.e. you select option 7a or 7b),
then you must select one of the six options on the Requirements Status,and Registrant's
Response Form related to data production for each data requirement. Your option selection
should be entered under item number 9, "Registrant Response." The six options related to
data production are the first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response Form. These six options are
listed immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time-frame (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to
the Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study)
Option 1. Developing Data — The requirements for developing product specific data are
the same as those described for generic data (see Section III.C.I, Option 1) except that
normally no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data ~ If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
IH.C.1, Option 2). However, registrants may only choose this option for acute toxicity
data and certain efficacy data and only if EPA has indicated in the attached data tables that
your product and at least one other product are similar for purposes of depending on the
same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which.data will be submitted must be
noted in the agreement to cost share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development --The same requirements for
generic data (Section III.C.I., Option 3) apply to this option. This option only applies to
acute toxicity and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study - The same requirements described for generic
data (see Section III.C.l., Option 4) apply to this option for product specific data.
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Option 5. Upgrading a Study — The same requirements described for generic data (see
Section ni.C.l., Option 5) apply to this option for product specific data;
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section III.C. 1., Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (III.C.I.), as appropriate. .
II-I-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your belief
that the data requirement(s) are not appropriate for your product.
a.
Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response
Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of
requiring data for low volume/minor use pesticides. In implementing this provision,
EPA considers low volume pesticides to be only those active ingredients whose total
production volume for all pesticide registrants is small. In determining whether to
grant a low volume, minor use waiver, the Agency will consider the extent, pattern
and volume of use, the economic incentive to conduct the testing, the importance of
the pesticide, and the exposure and risk from use of the pesticide. If an active
ingredient is used for both high volume and low volume uses, a low volume
exemption will not be approved. If all uses of an active ingredient are low volume
and the combined volumes for all uses are also low, then an exemption may be
granted, depending on review of other information outlined below. An exemption
will not be granted if any registrant of the active ingredient elects to conduct the
testing. Any registrant receiving a low volume/minor use waiver must remain
within the sales figures in their forecast supporting the waiver request in order to
remain qualified for such waiver. If granted a waiver, a registrant will be required,
- as a condition of the waiver, to submit annual sales reports. The Agency will
respond to requests for waivers in writing. ;
To apply for a low volume/minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this
Notice:
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(i). Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, include
foreign sales for those products that are not registered in this country but are
applied to sugar (cane or beet), coffee, bananas, cocoa, and other such crops'.
Present the above information by year for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each
of the past five years.
(iii) Total direct production cost of product(s) containing the active
ingredient by year for the past five years. Include information on raw material cost,
direct labor cost, advertising, sales and marketing, and any other significant costs
listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient by year for the
past five years. Exclude all non-recurring costs that were directly related to the
active ingredient, such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the
type of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of
these data requirements.
(vi) A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data requirement and
associated test) of conducting the testing needed to fulfill each of these data
requirements.
(vii) For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient, direct production costs of
product(s) containing the active ingredient (following the parameters in item 2
above), indirect production costs of product(s) containing the active ingredient
(following the parameters in item 3 above), and costs of data development
pertaining to the active ingredient.
(viii) A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, providing information
that is as quantitative as possible. If you do not have quantitative data upon which to
base your estimates, then present the reasoning used to derive your estimates. To
assist the Agency in determining the degree of importance of the active ingredient in
terms of its benefits, you should provide information on any of the following
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faqtors, as applicable to your product(s): (a) documentation of the usefulness of the .
active ingredient in Integrated Pest Management, (b) description of the beneficial
impacts on the environment of use of the active ingredient, as opposed to its
registered alternatives, (c) information on the breakdown of the active ingredient
after use and on its persistence in the environment, and (d) description of its
usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a
determination regarding a request for a low volume/minor use waiver will result in
denial of the request for a waiver. ,
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's
Response Form. This option may be used if you believe that a particular data
requirement should not apply because the requirement is inappropriate. You must
submit a rationale explaining why you believe the data requirements should not
apply. You also must submit the current label(s) of your product(s) and, if a current
copy of your Confidential Statement of Formula is not already on file you must
submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
product(s), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your product(s), you
must choose a method of meeting the requirements of this Notice within the time
frame provided by this Notice. Within 30 days of your receipt of the Agency's
written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the format required by
PR Notice 86-5). This will be the only opportunity to state the reasons or provide
information in support of your request. If the Agency approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA.
If the Agency denies your waiver request, you must choose an option for meeting
the data requirements of this Notice within 30 days of the receipt of the Agency's
decision. You must indicate and submit the option chosen on the product specific
Requirements Status and Registrant's Response Form. Product specific data
requirements for product chemistry, acute toxicity and efficacy (where appropriate)
are required for all products and the Agency would grant a waiver only under
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extraordinary circumstances. You should also be aware that submitting a waiver
request will not automatically extend the due date for the study in question. Waiver
requests submitted without adequate supporting rationale will be denied and the
original due date will remain in force.
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
NOTICE ~ "
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a
Notice of Intent to Suspend include, but are not limited to, the following:
1.
6.
7.
8.
Failure to respond as required by this Notice within 90 days of your receipt
of this Notice.
Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
Failure to submit on the required schedule acceptable data as required by this
Notice.
Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required action
or information pertaining to submission or citation of existing studies or
offers, arrangements, or arbitration on the sharing of costs or the formation
of Task Forces, failure to comply with the terms of an agreement or
arbitration concerning joint data development or failure to comply with any
terms of a data waiver).
Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
Withdrawal of an offer to share in the cost of developing required data.
Failure of the registrant to whom you have tendered an offer to share in the
cost of developing data and provided proof of the registrant's receipt of such
offer or failure of a registrant on whom you rely for a generic data
exemption either to:
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9.
a. Inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response Form.
b. Fulfill the commitment to develop and submit the data as required by this
Notice; or
c. Otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame. •
Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice. '
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE ~~~"~—
The Agency may determine that a study (even if submitted within the required time)
is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The
grounds for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-In Notice or~other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of required studies. Such
requirements include, but are not limited to, those relating to test material, test
procedures, selection of species, number of animals, sex and distribution of
animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2) EPA .requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting
(or raw) data, including, but not limited to, requirements referenced or included in
this Notice or contained in PR 86-5. All studies must be submitted in the form of a
final report; a preliminary report will not be considered to fulfill the submission
requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or cancelled if doing so
would be consistent with the purposes of the Act.
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The Agency has 'determined that such disposition by registrants of existing .stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding generally
would not be consistent with the Act's purposes. Accordingly,.the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You also must explain why an "existing
stocks" provision is necessary, including a statement of the quantity of existing stocks and
your estimate of the time required for their sale, distribution, and use. Unless you meet
this burden, the Agency will not consider any request pertaining to the continued sale,
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will have,
under most circumstances, one year from the date your 90 day response to this Notice is
due, to sell, distribute, or use existing stocks. Normally, the Agency will allow persons
other than the registrant such as independent distributors, retailers and end users to sell,
distribute or use such existing stocks until the stocks are exhausted. Any sale, distribution
or use of stocks of voluntarily cancelled products containing an active ingredient for which
the Agency has particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the agency granting any additional time to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was due,
unless you demonstrate to the Agency that you are in full compliance with all Agency
requirements, including the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3-year study is scheduled to be
submitted, all progress reports and other information necessary to establish that you have
been conducting the study in an acceptable and good faith manner must have been
submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V.
REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding
unreasonable adverse effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the Agency of any factual
information they have, from whatever source, including but not limited to interim or
preliminary results of studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products are registered by the
Agency.
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SECTION VI.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
• this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical
Status Sheet.
All responses to this Notice must include completed Data Call-In Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and product specific data) and any other documents
required by this Notice, and should be submitted to the contact person(s) identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen,
only the Generic and Product Specific Data Call-In Response Forms need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice. .
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In Response Forms
with Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5-, List of Registrants Receiving This Notice
6 - Confidential Statement of Formula, Cost Share and Data Citation Forms
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ZINC PHOSPHIDE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Zinc phosphide.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Zinc phosphide. This attachment is to be used in conjunction with (1) the Product Specific
Data Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3)
the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-
Use Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DC! (Attachment
6) and (7) the Cost Share and Data Citation Forms in replying to this Zinc phosphide Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Zinc phosphide
are contained in the Requirements Status and Registrant's Response, Attachment 3. The
Agency has concluded that additional data on Zinc phosphide are needed for specific products.
These data are required to be submitted to the Agency within the time frame listed. These
data are needed to fully complete the reregistration of all eligible Zinc phosphide products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Frank Rubis at (703) 308-8184.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Frank Rubis
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Zinc phosphide
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ZINC PHOSPHIDE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Zinc phosphide.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of Zinc
phosphide. This attachment is to be used in conjunction with (1) the Generic Data Call-in
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Citation Forms in replying to this Zinc phosphide Generic Data Call In (Attachment F).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for Zinc
phosphide are contained in the Requirements Status and Registrant's Response, Attachment
C. The Agency has concluded that additional product chemistry data on Zinc phosphide are
needed. These data are needed to fully complete the reregistration of all eligible Zinc
phosphide products..
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Dana Lateulere at (703) 308-8044.
All responses to this Notice for the generic data requirements should be submitted to:
Susan Jennings, Chemical Review Manager
Reregistration Branch 3
Special Review and Registration Division (H7508W)
Office of Pesticiafide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Zinc phosphide
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Instructions For Completing The "Data Call-In Response Forms" For The Generic
And Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response
Forms" and are to be used by registrants to respond to generic and product specific Data
Call-ins as part of EPA's Reregistratioh Program under the Federal Insecticide, Fungicide,
and Rodenticide Act. If you are an end-use product registrant only and have been sent
this DCI letter as part of a RED document you have been sent just the product specific
"Data Call-In Response Forms." Only registrants responsible for generic data have been
sent the generic data response form. The type of Data Call-In (generic or product
specific) is indicated in item number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling
out the forms.
EPA has developed these forms individually for each registrant, and has preprinted these
forms with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed
by the registrant as appropriate. Items 8 through 11 must be completed by the registrant
before .submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to
Chief, Information Policy Branch, Mail Code 2137, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, D.C. 20460; and to the Office of Management
and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR "COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
.Item 3. ON BOTH FORMS: This item identifies the type of Data Call-In. The
date of issuance is date stamped.
Item 4. ON BOTH FORMS: This item identifies the EPA product registrations
relevant to the data call-in. Please note that you are also responsible for
informing the Agency of your response regarding any product that you
believe may be covered by this Data Call-In but that is not listed by the
Agency in Item 4. You must bring any such apparent omission to the
Agency's attention within the period required for submission of this response
form.
Item 5. ON BOTH FORMS: Check this item for each product registration you wish
to cancel voluntarily. If a registration number is listed for a product for
which you previously requested voluntary cancellation, indicate in Item 5 the
date of that request. Since this Data Call-In requires both generic and
product specific data, you must complete item 5 on both Data Call-In
response forms. You do not need to complete any item on the Requirements
Status and Registrant's Response Forms.
i
Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is
for generic data as indicated in Item 3 and you are eligible for a Generic
Data Exemption for the chemical listed in Item 2 and used in the subject
product. By electing this exemption, you agree to the terms and conditions
of a Generic Data Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you may complete this item
for all products listed on this form. If, however, you produce the active
ingredient yourself, or use any unregistered product (regardless of the fact
170
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that some of your sources are registered), you may not claim a Generic Data
Exemption and you may not select this item.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 6b. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is
for generic data as indicated in Item 3 and if you are agreeing to satisfy the
generic data requirements of this Data Call-In. Attach the Requirements
Status and Registrant's Response Form that indicates how you will satisfy
those requirements.
'";
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item 7a. ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing
use product (MUP) for .which you wish to maintain registration, you must
agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish "to maintain registration,
you must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's)
if your product is identical to another product and you qualify for a data
exemption. You must provide the EPA registration numbers of your
source(s); do not complete the Requirements Status and Registrant's
Response form. Examples of such products include repackaged products arid
Special Local Needs (Section 24c) products which are identical to federally
registered products.
If you are requesting a data waiver, answer "yes" here; in addition, on the
"Requirements Status and Registrant's Response" form under Item 9, you
must respond with option 7 (Waiver Request) for each study for which you
are requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
171
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INSTRUCTIONS FOR" COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 8. ON BOTH FORMS: This certification statement must be signed by an
authorized representative of your company and the person signing must
include his/her title. Additional pages used in your response must be
initialled and dated in the space provided for the certification.
Item 9. ON BOTH FORMS: Enter the date of signature.
Item 10, ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. ON BOTH FORMS: Enter the phone number of your company contact.
Note;
You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you may
wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
Instructions For Completing The "Requirements Status and Registrant's Response
Forms" For The Generic and Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status
and Registrant's Response Forms" and are to be used by registrants to respond to generic
and product specific Data Call-in's as part of EPA's reregistration program under the
Federal Insecticide, Fungicide, and Rodenticide Act. If you are an end-use product
registrant only and have been sent this DCI letter as part of a RED document you have
been sent just the product specific "Requirements Status and Registrant's Response
Forms." Only registrants responsible for generic data have been sent the generic data
response forms. The type of Data Call-In (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both product specific and generic data,
instructions for completing the forms differ slightly. Specifically, options for satisfying
product specific data requirements do not include (1) deletion of uses or (2) request for a
low volume/minor use waiver. Please read these instructions carefully before filling out
the forms.
172
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EPA has developed these forms individually for each registrant, and has preprinted
these forms to include certain information unique to this chemical. DO NOT use these
Jforms for any other active ingredient.
Items 1 through 8 have been preprinted oh the form. Item 9 must be completed by
the registrant as appropriate. Items 10 through 13 must be completed by the registrant
before submitting a response to the Agency. - • .
The public reporting burden for this collection of information is estimated to :
average 30 minutes per response, including time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments .regarding the burden estimate or
any other aspect of this.collection of information, including suggestions for reducing this
burden, to Chief, Information Policy Branch, Mail Code 2136, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and to the Office of
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C.
20503.
173
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176
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number,
case name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
case number, case name, and the EPA Registration Number of the product
for which the Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-In. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
type of Data Call-in. The date of issuance is also date stamped. Note the
unique identifier number (ID#) assigned by the Agency. This ID number "
must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number.of
studies required. These guidelines, in addition to the requirements specified
in the Data Call-in Notice, govern the conduct of the required studies. Note
that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpartc.
Item 5. ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1,2, or 3-year
progress reports are required to be submitted in connection with the study.
- As noted in Section III of the Data Call-in Notice, 90-day progress reports
are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and Registrant's
Response Form.
177
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 6. ON BOTH FORMS: This item identifies the code associated with the use
pattern of the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use
sites and/or pests indicated. A brief description of each code follows:
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 crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
Item 7. ON BOTH FORMS: This item identifies the code assigned to the substance
that must be used for testing. A brief description of each code follows:
EUP
•MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
178
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Item 8.
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA.
TGAI/TEP
MET
IMP
DEGR
*
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient .
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product .
Metabolites
Impurities
Degradates
See: guideline comment
This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of
your receipt of the Data Call-In notice.
ON THE PRODUCT SPECIFIC DATA FORM: The due date for
submission of product specific studies begins from the date stamped on the
letter transmitting the Reregistration Eligibility Decision document, and not
from the date of receipt. However, your response to the Data Call-In itself
is due 90 days from the date of receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to
show how you intend to comply with each data requirement. Brief
descriptions of each code follow. The Data Call-In Notice contains a fuller
description of each of these options.
Option 1. ON BOTH FORMS: (Developing Data) I will conduct a new study
and submit it within the time frames specified in item 8 above. By
indicating that I have chosen this option, I certify that I will comply
with all the requirements pertaining to the conditions for submittal of
this study as outlined in the Data Call-In Notice and that I will
provide the protocols and progress reports required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Share) I have entered into
an agreement with one or more registrants to develop data jointly. By
indicating that I have chosen this option, I certify that I will comply
with all the requirements pertaining to sharing in the cost of
developing data as outlined in the Data Call-In Notice.
179
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However, for Product Specific Data, I understand that this
option is available for acute toxicity or certain efficacy data ONLY if
the Agency indicates in an attachment to this notice that my product is
similar enough to another product to qualify for this option. I certify
that another party in the agreement is committing to submit or provide
the required data; if the required study is not submitted on time, my
product may .be subject to suspension.
Option 3. ON BOTH FORMS: (Offer to Cost Share) I have made an offer to
enter into an agreement with one or more registrants to develop data
jointly. I am also submitting a completed "Certification of offer to
Cost Share in the Development of Data" form. I am submitting
evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I ,am
including a copy of my offer and proof of the other registrant's
receipt of that offer. I am identifying the party which is committing
to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. I
, understand that other terms under Option 3 in the Data Call-In Notice
apply as well.
However, for Product Specific Data, I understand that this
option is available only for acute toxicity or certain efficacy data and
only if the Agency indicates in an attachment to this Data Call-In
Notice that my product is similar enough to another product to qualify
for this option.
' ' ! i
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will submit an
existing study by the specified due date that has never before been
submitted to EPA. By indicating that I have chosen this option, I
certify that this study meets all the requirements pertaining to the
conditions for submittal of existing data outlined in the Data Call-In
Notice and I have attached the needed supporting information along
with this response.
Options. ON BOTH FORMS: (Upgrading a Study) I will submit by the
specified due date, or will cite data to upgrade a study that EPA has
classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all
the requirements pertaining to the conditions for submitting or citing
existing data to upgrade a study described in the Data Call-In Notice.
I am indicating on attached correspondence the Master Record
Identification Nuriiber (MRID) that EPA has assigned to the data that
I am citing as well as the MRID of the study I am attempting to
upgrade.
180
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Option 6. ON BOTH FORMS: (Citing a Study) I am citing an existing study
that has been previously classified by EPA as acceptable, core, core
minimum, or a study that has not yet been reviewed by the Agency. If
reviewed, I am providing the. Agency's classification of the study.
However, for Product Specific Data, I am citing another
registrant's study. I understand that this option is available ONLY
for acute toxicity or certain efficacy data and ONLY if the cited study
was conducted o'n my product, an identical product or a product
which the Agency has "grouped" with one or more other products for
purposes of depending on the same data. I may also choose this option
if I am citing my own data. In either case, I will provide the MRID or
Accession number (s). If I cite another registrant's data, I will
submit a completed "Certification With Respect To Data Citation
Requirements" form.
FOR THE GENERIC DATA FORM ONLY: The following three options
(Numbers 7, 8, and 9) are responses that apply only to the "Requirements
Status and Registrant's Response Form" for generic data.
Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In
Notice and I request a low-volume minor use waiver of the data
requirement. I am attaching a detailed justification to support this
waiver request including, among other things, all information
required to support the request. I understand that, unless modified by
the Agency in writing, the data requirement as stated in the Notice
governs.
Option 9. (Request for Waiver of Data) I have read the statements concerning
data waivers other than lowvolume minor-use data waivers in the Data
Call-In Notice and I request a waiver of the data requirement. I am
attaching a rationale explaining why I believe the data requirements
,do not apply. I am also submitting a copy of my current labels. (You
must also submit a copy of your Confidential Statement of Formula if
not already on file with EPA). I understand that, unless modified by
the Agency in writing, the data requirement as stated in the Notice
governs. .
181
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FOR PRODUCT SPECIFIC DATA: The following option (number 7) is a
response that applies to the "Requirements Status and Registrant's Response
Form" for product specific data.
Option 7. (Waiver Request) I request a waiver for this study because it is
inappropriate for my product. I am attaching a complete justification
for this request, including technical reasons, data and references to
relevant EPA regulations, guidelines or policies. [Note: any
supplemental data must be submitted in the format required by P.R.
Notice 86-5]. I understand that this is my only opportunity to state the
reasons or provide information in support of my request. If the
Agency approves my waiver request, I will not be required to supply
the data pursuant to Section 3(c) (2) (B) of FIFRA. If the Agency
denies my waiver request, I must choose a method of meeting the data
requirements of this Notice by the due date stated by this Notice. In
this case, I must, within 30 days-of my receipt of the Agency's
written decision, submit a revised "Requirements Status" form
specifying the option chosen. I also understand that the deadline for
submission of data as specified by the original Data Call-In notice
will not change.
Item 10. ON BOTH FORMS: This iteih must be signed by an authorized
representative of your company. The person signing must include his/her
title, and must initial and date all other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
NOTE:
You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example, you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
182
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194
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EPA'S BATCHING OF PRODUCTS CONTAINING ZINC PHOSPHIDE AS THE
ACTIVE INGREDIENT 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 the active ,
ingredient zinc phosphide, the Agency has batched products which can be considered similar
.in terms of acute toxicity. Factors considered in the sorting process include each product's
active and inert ingredients (identity, percent composition and biological activity), product
: form (liquid, paste, solid, etc.), and labeling (e.g., signal word, precautionary labeling, etc.).
Using available information, batching has been accomplished by the process described in -
the preceding paragraph. Notwithstanding 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 lexicological 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 lexicological 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
t 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. TRB must approve any new formulations (that were
presented to the Agency after the publication of the RED) before data derived from them can
be used to cover other products in a batch. 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
195
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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.
Table 1 displays the batches for the active ingredient zinc phosphide.
Table 1,
Batch
1
2
3
4
5
Registration
Number
769-741
61282-3
769-656
769-743
4221-11
12455-24
61282-13
769-756
56228-6
1 56228-9
ID91001800
TX95000200
7173-197
12455-16
4-152
Percent Active Ingredient
zinc phosphide ... 94%
zinc phosphide ...93%
zinc phosphide ...80%
zinc phosphide ...80%
zinc phosphide ... 80%
zinc phosphide ... 80%
zinc phosphide ...82%
zinc phosphide ...62%
zinc phosphide ...63.2%
zinc phosphide ...63.2%
zinc phosphide ... 63.2%
zinc phosphide ... 63.2%
zinc phosphide ...10.3%
zinc phosphide ...10.0%
zinc phosphide ...2%
Form
powder
powder
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
196
-------
4-285
30-25
192-204
192-205
322-8
358-165
814-9
2393-185
2393-521
. 2393-522
4271-16
5887-179
, 7122-124
7173-195
12455-17
'12455-18
12455-30
12455-59
12455-85
13808-6
36029-10
36029-12
36029-13
zinc phosphide ...2%
zinc phosphide ... 2%
zinc phosphide ... 2%
zinc phosphide " ...2%
zinc phosphide ... 2%
zinc phosphide ... 2%
zinc phosphide ...2%
zinc phosphide ... 2%
zinc phosphide ... 2%
zinc phosphide ...2%
zinc phosphide ... 1.82%
zinc phosphide ... 2%
zinc phosphide -...2%
zinc phosphide ...1.88%
zinc phosphide ... 2%
zinc phosphide . ...2%
zinc phosphide - ... 2%
zinc phosphide • ...2%
zinc phosphide ... 2%
zinc phosphide . ...2%
zinc phosphide ...2%
zinc phosphide ...2%
zinc phosphide ... 2%
solid
solid
solid'
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
197
-------
56228-3
56228-14
61282-14
61282-20
CA89002600
CA89002700
HI96000700
IL97000100
IN83000300
KS97000100
KY96000500
MO96001400
MT89000900
MT95000300
NE97000100
OH85000100
OR95002100
TX95000200
VT90000200
WA9 1000300
WA9 100 1800
WA95002200
WY92000200
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide.
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
zinc phosphide
... 1.82%
... 2%
... 2%
... 2%
... 1%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
... 2%
• ...2%
'... 2%
... 2%
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
solid
198
-------
WY92000300 zinc phosphide
... 2%
solid
There was no "No Batch" group for this RED.
199
-------
The following is a list of available documents for Zinc phosphide that my further assist
you in responding to this Reregistration Eligibility Decision document. These documents may
be obtained by the following methods:
Electronic •
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the internet using WWW
(World Wide Web) at www.epa.gov/REDs.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
\
4. A copy of the fact sheet for zinc phosphide.
The following documents are part of the Administrative Record for Zinc phosphide and
may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person listed
on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may
be obtained by contacting the person listed on the Chemical Status Sheet of this RED
document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
200
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible
party must be provided. . , .
• . - - - v " • i •
d. All applicable information which is on the product specific data submission
must also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids. •
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
.registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all'actives and inerts and
all common names for the trade names must be reported.
i. For the'active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14-b. for the active ingredients must
represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
201
-------
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (G.SF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a.
b.
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d. All applicable information which is on the product specific data submission
must also be reported on the CSF.
All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
The Chemical Abstracts Service (CAS) Numbers for all .actives and inerts and
all common names for the trade names must be reported.
For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
All the items under column 13.b. must total 100 percent.
All items under columns 14.a. and 14.b. for the active ingredients must
represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n.
When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
203
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\
United States Environmental Protection Agency
Washington, D.C. 20460
Certification of Offer to Cost
Share in the Development of Data
Form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
Public reporting burden for this collection of information is estimated to average 15 minutes per response,
ncluding time for reviewing instructions, searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information. Send comments regarding the burden
estimate or any other aspect of this collection of information, including suggestions for reducing this burden to, .
Chief Information Policy Branch, PM-233, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC
20460; and to the Office of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC
20503.
Please fill in blanks below:
Company Name
Company Number
'roduct Name
EPA Reg. No.
Certify that:
Wly company is willing to develop and submit the data required by EPA under the authority of the Federal
nsecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to
»nter into an agreement with one or more registrants to develop jointly or share in the cost of developin"
a.
i/ly firm has offered in writing to enter into such an agreement. That offer was irrevocable and included
m an offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on
all terms could not be reached otherwise. This offer was made to the following firms on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that \ have made
on this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false
or misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Mame and Title (Please Type or Print)
orm 8570-32 (5/91) Replaces EPA form 8580 which is obselete
Form Approved OMB No. 2070-0060
207
-------
208
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
aperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1,25 hours per response for
registration and 0.25 hours per response for reregistration and spe'cial review activities, including time for reading the instructions and completing the
necessary forms. Send comments regarding burden estimate or any'other aspect of this collection of information, including suggestions for reducing th
burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S W Washington DC
20460. ' . .
Do not send the completed form to this address.
Certification with Respect to Citation of Data
Applicant's/Registrant's Name, Address, and Telephone Number
EPA Registration Number/File Symbol
Active Ingredient(s) and/or representative test compourid(s)
Date
General Use Pattern(s) (list all those claimed for this product using 40 CFR Part 158),
Product Name
NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not neec
to submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27).
D
I am responding to a Data-Call-in Notice, and have included with this form.a list of companies sent offers of compensation (the Data Matrix forn
should be used for this purpose). -
SECTION I: METHOD OF DATA SUPPORT (Check one method only)
. I am using the cite-all method of support, and have included with this
form a list of companies sent offers of compensation (the Data Matrix
form should be used for this purpose).
I am using the selective method of support (or cite-all option
under the selective method), and have included with this form
a completed list of data requirements (the Data Matrix form
must be used).
SECTION II: GENERAL OFFER TO PAY
[Required if using the cite-all method or when using the cite-all option under tne selective method to satisfy one or more data requirements]
I | I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.
SECTION III: CERTIFICATION
I certify that this application for registration, this form for reregistration, or this Data-Call-in response is supported by all data submitted or
cited in the application for registration, the form for reregistration, or the Data-Call-in response. In addition, if the cite-all option or cite-all option under
the selective method is indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects of
this product or an identical or substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be
required to be submitted under the data requirements in effect on the date of approval of this application if the application sought the initial registration o
a product of identical or similar composition and uses .
I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the originaldata submitter or that I hav
obtained the written permission of the original data submitter to cite that study. '
I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am the original
data submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility
for compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study
and have offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2)(B)'of FIFRA; and (ii).to commence negotiations to
determine the amount and terms of compensation, if any, to be paid for the use of the study.
I certify tha't in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery
in accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should I fail to
produce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my
product in conformity with FIFRA. , , .
I certify that the statements I have made on this form and all attachments to it are true, accurate, and complete. I acknowledge that
any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.
^nature ~
Date
Typed or Printed Name and Title .
Jf\ rorm H3/U-J4 (9-9/) tiectronic and Paper versions available. Submit only Paper version.
209
-------
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INSTRUCTION? 1 DATA MATRIX
jenfify afl data submitted orded and all submitters from whom permissk «s been received or to whom offers to pay hav
Irix (photocopy and attach additional pages as necessary). Complete all columns; omission of essential information will de
[erthe dale, Applicant's/Registrant's name, EPA Registration Number or application file symbol of the product, ingredie
sation Form entitled "Certification with Respect to Citation of Data" and the Data Matrix will be publicly available, except fo
MRID Number columns after the registration/reregistration of this product has been granted or once this form is received in
the Guideline Reference Number, Guideline Study Nameand MRID Number columns is available through the Freedom c
ber.
fy the active ingredient(s) in this product for which dta are cited. The active ingredient(s) are to be identified by entering the i
for each separate active ingredient for which data are cited. If bridging data from a related chemical or representative test
ntative test compound including the EPA Registration Number/File Symbol if appropriate.
i-all method is used for all data supporting this particulaingredient, enter "CITE-ALL" in the Guideline Reference Number
he cite-all method is used for a particular Guideline Reference Number enter "CITE-ALL" in the MRID Number column on 1
;r all submitters to whom offers to pay have been sent on subsquent lines. [Note: if the selective method of support is used z
idividual Guideline Reference Number, Guideline Study Name, and MRID Number columns must still be completedtDthei
rence Number: Enter on separate lines in numerical order the Guideline Reference Numbers from 40 CFR Pa
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istration for this ingredient.
Name: For each Guideline Reference Number cited, enter the corresponding Guideline Study Name.
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or each individual study cited ireupport of a Guideline Reference Number and Guideline Study Name, enter the Master Rec
nt Management System (PDMS). Enter oty one MRID Number on each line. Note that more than one MRID Number may t
y a study required to maintain a regitration/reregistration is not associated with a Guideline Reference Number and Guidelin
i study(ies).
Ithe most recent Data Submitters List, identify the Original Data Submitter with their current address for each study cited.
be used. Clearly explain any variations (alternate addresses, data owners not on the Data Submitters List, etc.) in footn
ie of the following codes for each study cited, as appropriate:
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