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4,
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unpublished materials submitted to the Agency, the Agency has sought to identify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 citationrand 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 aftej 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 laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b.
Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document. . .
75
-------
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.
* . '
f
(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.
76
-------
BIBLIOGRAPHY
MRID
CITATION
00035896
00035997
00035998
00037279
00045294
00045295
00054672
00083155'
Wiedmann, J.L.;.Pensyl, J. (1975) Proposed Regulatory Method for CIPC
Residue (CIPC + Metabolite III): BR 1 971 8 . Method dated May 2, 1 975 . .
(Unpublished study received May 8, 1975 under 4F 1429; submitted by PPG
Industries, Inc., Barberton, Ohio; CDL: 0938 11 -D)
Ecke, G.G. (1976) Qualitative Investigation of CIPC Metabolites in Bluegill
Sunfish: Final Report: BR 203 15 A, (Unpublished study received Sep 21, 1976
under 748-161; submitted by PPG Industries, Inc., Barberton Ohio;
CDL:095292^E) ?
.S. (1976) Report: Bluegill Sunfish, Tissue Residue Levels following
Exposure to 14C-CIPC: Laboratory No. 6E-1 100A. (Unpublished study
received Sep 21, 1976, under 748-161; prepared by Cannon Laboratories, Inc.,
submitted by PPG Industries, Inc., Barberton, Ohio; CDL:095292-F)
Reinert, H.K.; Parke, G.SiE. (1975) Report: Static-96-Hour Toxicity Study of
PPG Industries, Incorporated Sample CIPC Technical in Bluegill Sunfish and
Rainbow Trout: Laboratory No. 5E-8034. (Unpublished study received Sep 21,
1976 under 748-161; prepared by Cannon Laboratories, Inc,, submitted by PPG
Industries, Inc., Barberton, Ohio; CDL:Q95292-AA)
v . .,,'.,, ......
PPG Industries, Incorporated (1969) General Analytical Method for
Determining CIPC Residues in Crops Designated in the Summary Table as
Being Analyzed by MF (Ext.). (Unpublished study received Dec 3 1, 1970
under IF1 119; CDL:093430-D) ' ;
PPG Industries, Incorporated (1968) General Analytical Method for
Determining CIPC Residues in Crops Designated in the Summary Table as=
Being Analyzed by the MF (TCH-Dist) Method. (Unpublished study received
Dec 31, 1970 under 1F1 1 19; CDL:093430-E)
Dave, B. (1977) Residue Data of CIPC on Potatoes, (Unpublished study
received.Aug 26, 1977 under 4581 -EX-30; submitted by Pennwalt Corp
Philadelphia, Pa.; CDL:23 183 1-T)
Gard, L.K (1 959) Determination of isopropyl~N~-(3-chlorophenyl) carbarhate
residues, in potatoes treated for sprout inhibition. Journal of Agricultural and
Food Chemistry, 7(5):339-34 1 . (Also~In'~unpublished submission received
Dec 1, 1959 under PP0234; submitted by Columbia-Southern Chemical Corp
:Pittsburgh, Pa.; CDL.-090262-G)
77
-------
BIBLIOGRAPHY
MRID
CITATION
00093915
00093921
00114695
00114700
00114701
00114710
00114715
00114718
00114729
Ross, D.B.; Roberts, N.L.; Phillips, C.N.K.; et-al. (1980) The Acute Oral
Toxicity (LD50) and the Neurotoxic Effects of CIPC on the Domestic Hen:
PPG 4 NT/80188. (Unpublished study received Jan 25, 1982 under 748-161;
prepared by Huntingdon Research Centre, England, submitted by PPG
Industries, Inc., Barberton, Ohio; CDL:246648-A)
Rodwell, D.E.; Krabbe, R.; Werchowski, K.M. (1981) A Teratology Study in
Rats with CIPC: WIL-81107. (Unpublished study received Jan 25, 1982 under
748-161; prepared by WIL Research Laboratories, Inc., submitted by PPG
Industries, Inc., Barberton, Ohio; CDL:246650-A)
Fredenburg, R. (1960) Letter sent to E. Plant dated Nov 8, 1960: Emulsifiable '
sprout nip: Chloro-IPC. (Unpublished study received Feb 14, 1961 under
748-182; submitted by PPG Industries, Inc., Barberton, OH; CDL:024269-B)
Kennedy, G.; Jenkins, D. (1970) Report to PPG Industries, Inc.: Distribution of
CIPC in Milk and Tissues of a Lactating Cow: ffiT No. J8629A. (Unpublished
study received on unknown date under IF 1119; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by PPG Industries, Inc., Barberton, OH;
CDL:090892-I) . '
Kennedy, G. (1970) Report to PPG Industries, Inc.: Tissue and Egg Residue
Study of CIPC in White Leghorn Chickens: TBT No, J8630A, (Unpublished
study received on'unknown date under IF 1119; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by PPG Industries, Inc., Barberton, OH;
CDL:090892-J) '" .
A .
Pittsburgh Plate Glass (1967) Study: CIPC Residue on Selected Crops.
(Compilation; unpublished study received Aug.23, 1967 under 8F0690;
CDL:091198-A)
PPG Industries, Inc. (1972) Petition of PPG Industries, Inc. Pursuant to Section
408 (d)(l) of the Federal Food, Drug and Cosmetic Act with Respect to-the
Pesticide Chemical Chlorpropham. (Compilation; unpublished study received
Jun 1, 1972 under 2F1276; CDL:092107-A)
Columbia-Southern Chemical Corp. (1960) Analyses for Residues of CIPC and
Other Chemicals in Potatoes. (Compilation; unpublished study received on
unknown date under PP0234; CDL: 092511-A)
Ecke, G.; Pensyl, J. (1978) Hydrolysis of Isopropyl 3-Chlorocarbanilate
(CIPC): BR 20955. (Unpublished study received Feb 3, 1978 under 748-161;
submitted by PPG Industries, Inc., Barberton, OH; CDL:096789-B)
78
-------
BIBLIOGRAPHY
MRID
CITATION
0011473,9
00114741
00114747
00114750
00114751
00114777
00114785
00114794
00114795
00115388
00126733
PPG Industries, Inc. (1974) Analyses for Residues of CIPC Chemicals in
Various Products |. (Compilation; unpublished study received on unknown
date under 4F1429; CDL:098173-A)
Columbia Southern Chemical Corp. (1960) Analyses for Residues of CIPC
Chemicals in Potatoes. (Compilation; unpublished study received on unknown
date under PP0234; CDL:098745-A)
PPG Industries, Inc. (1961) Analyses for Residues of CIPC in Potatoes.
(Compilation; unpublished study received Mar 17, 1961 under, unknown
admin, rio.; CDL: 120933-A) ' .
Food Machinery and Chemical Corp. (1956) Sprout Control in Irish Potatoes.
(Unpublished study received on unknown date under unknown admin no "
CDL:120940-A) ''
Gard, L. (1957?) Determination of..: (CIPC) Residues in Potatoes Treated for
Sprout Inhibition. (Unpublished study received Nov 24, 1958 under unknown
admin, no.; submitted by PPG Industries, Inc., Barberton, OH; CDL: 120941-A)
Agchem (1978) Analyses for Residues of CIPC in Potatoes. (Compilation;
unpublished study received Aug 14, 1978 under 4581-EX30; CDL:234638-A)
Agchem (1978) Residue Data of dPCon Potatoes. (Compilation; unpublished
study received Nov 21, 1978 under 4581-338; CDL: 235995-G)
PPG Industries, Inc. (1979) Analyses for Residues of Furloe 124 and Other
Herbicides in Various Products.-.(Compilation; unpublished study received Jun
13, 1979 under 748-220; CDL:238627-A)
PPG Industries, Inc. (1979) Summary of 1978-1979 Tests Using Decco Brand
CIPC-AR under EPA Permit #4581-EUP-30. -(Compilation; unpublished study
received Jul 18, 1979 under 4581-EX-30; CDL: 238857-A)
PPG Industries, Inc. (1967) CIPC: Residues in Milk and Qther Subjects
(Compilation; unpublished study received on unknown date under IF 1120' -
CDL:090894-A) ' (
Haworth, S.; Lawlor, T.; Burke, J.; et al. (l'983),Salmonella/Mammalian-
microsome Plate Incorporation Mutagenicity Assay (Ames Test): PPG-134':
Study No, T1888.501. (Unpublished study received Apr 11, 1983 under
748-233; prepared by Microbiological Assoc., submitted by PPG Industries
Inc., Barberton, OH; CDL: 249883-A) '
79
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BIBLIOGRAPHY
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Haworth, S.; Lawlor, T.; Burke, J.; et af. (1983) Salmonella/Mammalian-
microsome Plate Incorporation Mutagenicity Assay (Ames Test): PPG-154:
Study No. T1889.501. (Unpublished study received Apr 11, 1983 under
748-233; prepared by Microbiological Assoc., submitted by PPG Industries,
Inc., Barberton, OH; CDL: 249883-B)
Schroeder, R.; Daly, I.; Hogan, G.; et al. (1983) A Two Generation
Reproduction Study in Rats with CIPC: Proj ect No. 81 -25 73. Final rept.
(Unpublished study received Jul 19, 1983 under 748161; prepared by
Bio/dynamics, Inc., submitted by PPG Industries, Inc., Bareberton OH
CDL:250764-A; 250765; 250766)
Kirby, P.; Pizzarello, R.; Rogers, A.; et al. (1983) L5178Y/TK+/Mouse
Lymphoma Mutagenesis Assay: ... Test Article CIPC, Isopropyl
3-Chlorocarbanilate: Study no. Tl 890.701. (Unpublished study received Jul
26, 1983 under 748-161; prepared by Microbiological Assoc., submitted by
PPG Industries, Inc., Barberton, OH; CDL:250808-A)
James, P.; Billington, R.; Clark, R.; et al. (1983) A study of the Effect of CIPC
on Pregancy of the Rabbit: HRC Report No. PPG 5&7/S328. (Unpublished
study received Jul 26, 1983 under 748161; prepared by Huntingdon Research
Centre, Eng., submitted by PPG Industries, Inc., Barberton, OH
CDL:250809-C)
Bowman, J. (1987) Acute Toxicity of Chlorpropham (CIPC Technical) to
Bluegill Sunfish (Lepomis macrochirus): Fijial Report #35418. Unpublished
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Bowman, J. (1987) Acute Toxi city of Chlorpropham (CIPC Technical) to
Rainbow Trout (Salmo gairdneri): Final Report #35419. Unpublished study
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Dougherty, K. (1989) The Acute Oral Toxicity of Chlorpropham Technical
(SX-1817) in Adult Male and Female Rats: Project ID: CEHC 2993; S-3173.
Unpublished study prepared by Chevron Environmental Health Center Inc 36
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Dougherty, K. (1989) The Acute Dermal Toxicity of ChlorprophamTechnical
(SX-1817) in Adult Male and Female Rabbits: Project ID: CEHC 2994;
S-3174. Unpublished study prepared by Chevron Environmental Health
Center, Inc. 14 p. .
80
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BIBLIOGRAPHY
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Dougherty, K, (1989) The Acute Eye Irritation Potential of Chlorpropham
Technical (SX-1 817) in Adult Albino Rabbits: Project ID: CEHC 2995;
S-3 1 75, Unpublished study prepared by Chevron Environmental Health'
Center. 16 p. ,
k, ' '..' '
Dougherty, K. (198 9) The Four-Hour Skin Irritation Potential of Chlorpropham
Technical (SX-1817) in Adult Albino Rabbits: Project ID: CEHC 2996;
S-3 1 76. Unpublished study prepared by "Chevron Environmental Health
Center, Inc. 17 p.
Dougherty, K, (1989) Modified Buehler Test for the Skin Sensitization
Potential of Chlorpropham Technical: Project ID: CEHC 2997; S-3 177.-
Uhpublished study prepared by Chevron Environmental Health Center, Inc 47
' " ' '"" ' " " ' ' '
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41763401
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41845501
,41846701
41863101
Krohmer, R. (1990) Primary Ocular Irritation Evaluation of Chlorpropham in
Rabbits: Lab Project Number: 393E-303-912-89. Unpublished study prepared
by T.P.S., Inc. 28 p. . . ,
Krohmer, R. (1990) Evaluation of the Dermal Sensitization Potential of
Chlorpropham in Guinea Pigs: Lab Project No: 393B-201-215-89. Unpublished
study prepared by T.P.S., Inc. 41 p..
Krohmer, R. (1990) Primary Dermal Irritation Evaluation of Chlorpropham in
Rabbits: Lab Project Number: 393D-302.211-89. Unpublished study prepared
by T.P.S., Inc. .27. p, ' . -
.... ... .j ซ... ... . ... .. ..
Krohmer, R. (1990) Acute Oral Toxicity Evaluation of Chlorpropham in Rats
Lab Project Number: 393A-1017010-89. Unpublished study prepared by
T.P.S.,inc. 39 p. . . '
Poiley, J. (1991) In vitro Transformation Assay of Chlorpropham Using Syrian
Hamster Cells: Lab Project Number: HLA A2276-0485R. Unpublished study
prepared by Hazleton Labs America, Inc. 87 p.
Miirli, H. (1 99 1 ) Mutagenicity Test on Chlorpropham in an in vitro
Cytogenetic Assay Measuring Chromosomal Aberration Frequencies Chinese
Hamster Ovary (CHO) Cells: Final Report: Lab Project No: 12276-0-437.
Unpublished study prepared by Hazleton Laboratories America, Inc. 60 p.
Wedig, J. (1990) 90 Day Subchronic Toxicity Evaluation of Chlorpropham in
the Rat: Lab Project Number: 3 93 G-l 02-034-89. Unpublished study prepared
byT.P.S., Inc. 401 p. ^ . > *- r
81
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BIBLIOGRAPHY
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899301 Krohmer, R. (1990) 90 Day Subchronic Toxicity Evaluation of Chlorpropham
in thfe Mouse: Lab Project Number: 393H-001-034-89. Unpublished study
prepared by T.P.S., Inc. 427 p.
41899901 Krohmer, R. (1990) 21 Day Dermal Toxicity Evaluation of Chlorpropham in
Rabbits: Lab Project Number: 393F-304-231-89. Unpublished Study prepared
by T.P.S., Inc. 168 p.
42006901 Robinson, R.; Liu, D. (1991) Metabolism of 14-Carbon Chlorpropham in Rats:
Definitive FIFRA Study, Metabolism Analysis and Quantisation; Final Report:
Lab Project Number: XBL90051: RPT0058. Unpublished study prepared by
Xenobiotic Labs, Inc. and Biological Test Center. 615 p.
42058903 Wartanessian, S. (1991) Physical and Chemical Chatacteristics of
Chlorpropham: Lab Project Number: CIPC B6101-R/89. Unpublished study
prepared by Atochem North America, Inc. 20 p.
42085601 Kim-Kang, H. (1991) Metabolism of Carbon fourteen Chlorpropham in Stored
Potatoes: Nature of the Residue in Potatoes: Lab Project Number: XBL 89070:
RPT0066. Unpublished study prepared by XenoBiotic Laboratories, Inc. 167
P- .
42112201 Wu, D. (1991) Metabolism of Carbon 14-Chlorpropham in Lactating Goats:
Metabolite Analysis and Quantisation in Milk and Tissues: Final Report: Lab
Project Number: XBL 9.0055: RPT0061. Unpublished study prepared by
XenoBiotic Laboratories, Inc. 231 p.
42123101 Moller, G. (1991) Analytical Method for Magnitude of Residues in Stored
Potatoes from Postharvest Treatments of Chlorpropham: Final Report: LAb
Project Number: 91CIPC01. Unpublished study prepared by Univ. of Idaho
Analytical Lab, Holm Research Ctr. 87 p.
42130401 Wu, D. (1991) Metabolism of Carbon 14-Chlorpropham in Laying Hens:
Metabolite Analysis and Quantisation in Eggs and Tissues: Lab Project
Number: XBL 90053: RPT0073. Unpublished study prepared XenoBiotic
Labs, Inc. 228 p.
I
42183701 Wise, J. (1988) Chlorpropham Physical and Chemical Properties. Unpublished
study prepared by MTM Agrochemicals Ltd. 18 p.
42183702 Wise, J. (1988) Chlorpropham Preliminary Analysis. Unpublished study
prepared by MTM Agrochemicals Ltd. 22 p.
82
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42653401
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Formation of Impurities, Unpublished study prepared by MTM Agrochemicals
Ltd. 27 p. ; / : ;"/ "..-."-1-".; '"' " -- .-V"-'"":.. ;. ' .<
Wedig, J. (1992) One Year Chronic Study of Chlorpropham in Dogs: Lab
Project Number: 393 J-502-640-89. Unpublished study prepared by T P S Inc
897 p. ' ,
Campbell, S.; Lynn, P. (1992) Chlorpropham (CIPC): A Dietary LC50 Study
with the Northern Bobwhite: Lab Project Number: 292-101. Unpublished
study prepared by Wildlife International Ltd. 39 p ,
Sved,'D.; Murhy, D ; Swigert/J. (1992);Ghlorprbpham (CIPC): A 48-hour
Static Acute Toxicity test with the Cladoceran (Daphnia magna): Final Report:
Lab Project Number: 292A-101B. Unpublished study prepared by Wildlife Int'l
Ltd. 43 p. ' . ; ;
Botta, J. (1992) 18 Month Oncogenicity Evaluation of Chlorpropham in the
Mouse: Lab Project Number: 393K-002-050-89. Unpublished study prepared -
by T.P.S., Inc. 1873 p. ^ ^^
Wulf, L. (1992) Final Report: Chlorpropham and 3-Chloroaniline Residue
Study on Potatoes, Potato Skins, Potato Chips and Potato Granules After
Post-Harvest Fumigation: Lab Project Number: 92-001. Unpublished study
prepared by Hibbs Analytical Laboratories, Inc. 51 p.
Wartariessian, S. (1992) Product Identity and Composition of Chlorpropham:
Lab Project Number: CIPC/92 HCDG, Unpublished study prepared by Elf
Atohem North America, DECCO. 49 p.
Kleinkopf, G.; Thomson, C. (1992) In-life Phase Study: Magnitude of Residues
in Stored Potatoes from Postharvest Treatments of Chlorpropham: Lab Project
Number: 92CIPC02, Unpublished study prepared by University of Idaho. 151
p. .-.. ' ' ,. .-':_. .; ' -, ' " .. . ..- - -. _ . . , ,
Walker, G.; Goodrick, B.; Haws, R.; et al. (1993) Analytical Method for
Magnitude of Residues in Stored Potatoes from Postharvest Treatments of
Chlorpropham: An Addendum: Lab Proj ect Number: 92CIPC01. Unpublished ^
study prepared by University of Idaho... 323 p.
83
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42653601
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42660101
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42741101
Gooflrick, B.; Haws, R.; Walker, G.; et al. (1993) Magnitude of the Residues of
Chlorpropham and Major Metabolites in or on Stored Potatoes Intended for the
Fresh Market: Lab Project Number: 92CIPC04. Unpublished study prepared
by University of Idaho. 193 p.
Goodrick, B.; Haws, R.; Walker, G.; et al. (1993) Magnitude of the Residues of
Chlorpropham and Major Metabolites in or on Stored Potatoes Intended for
Processing into Potato Chips: Lab Project Number: 92CIPC06. Unpublished
study prepared by University of Idaho. 181 p.
Goodrick, B.; Haws, R.; Walker, G.; et al. (1993) Magnitude of the Residues of
Chlorpropham and Major Metabolites in or on Stored Potatoes Intended for
Processing into Frozen or Dehydrated Products: Lab Project Number:
92CIPC05. Unpublished study prepared by University of Idaho. 181 p.
Haws, R.; Goodrick, B.; Walker, G.; et al. (1993) Determination of Storage
Stability of Field-Incurred Residues of Chlorpropham and Metabolites of
Concern in or on Fresh, Stored and Processed Potatoes: Lab Project Number:
92CIPC08. Unpublished study prepared by University of Idaho. 81 p.
Wojcieok, B. (1993) Chlorpropham: Density: Lab Project Number
4293-92-0142-AS: 4293-92-0412-AS-001. Unpublished study prepared by
Ricerca, Inc. 21 p.
Wojcieck, B. (1993) Chlorpropham: Oxidation-Reduction: Lab Project
Number: 4293-92-0418-AS: 4293-92-0418-AS-001. Unpublished study
prepared by Ricerca, Inc. 30 p. * '
Wojcieck, B. (1993) Chlorpropham-Color, Physical State, Odor, Melting
Point, Density, PH, Oxidation-Reduction, Impact Explodability: Lab Project
Number: 4075-92-0471-AS. Unpublished study prepared by Ricerca Inc 54
p.
Hambrick, A. (1993) Chlorpropham^-Dissociation Constant: Lab Project
Number: 4075-92-0446-AS-001: 4075-92-0446-AS. Unpublished study
prepared by Ricerca, Inc. 53 p. ,
Malone, S. (1993) Chlorpropham-Stability: Lab Project Number
4075-92-0477-AS: 4075-92-0477-AS-001. Unpublished study prepared by
Ricerca, Inc. 55 p.
84
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42744301
Hambrick, A. (1993) Chlorprophamr-Dissociation Constant: Lab Project
Number: 4293 -92-04 15 -AS. Unpublished study prepared by Ricerca, Inc 53
' '' ' ' '
42752201
42754301
42754401
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42772401
42778901
42796301
42807401.
42817301
. . - .-- -
, Wise, J. (1992) Response to EPA's Data Review of July 1, 1992: Product
Chemistry: Chloro IPC Technical (Chlorpropham). Unpublished study prepared
by John Wise & Associates, Ltd 12 P; : ' '
Lorence, P. (1993) Chlorpropham-Solubility: Lab Project Number
4075,92-0450- AS : 4075-92-0450- AS-001 : Unpublished study prepared by
Ricerca, Inc. 55 p.
Lorence, P. (1993) Chloipropham-OctanolAVater Partition Coefficient: Lab
Project Number: 4075-92-0448-AS: 4075-92-0448-AS-001. Unpublished
study prepared by Ricerca, Inc. 56 p. -.'. '
Botta, J. (1993) 24 Month Combined Oncogenicity/Toxicity Evaluation of
Chlorpropham in Rats: Final Report: Lab Project Number: 393L-103-055-89.
Unpublished study prepared by T.P.S., Inc. 3327 p. -
Lorence, P. (1 993) Chlorpropham-Vapor Pressure: Lab Project Number
4075-92-0449- AS: 4075-92-0449-AS-001. Unpublished study prepared by
Ricerca, Inc. 71 p.
. Boggess, K. (1 993) Validation of a Method for the Determination of
Chlorpropham (CIPC) arid Other Target Analytes from Potato Matrices: Lab
Project Number: 3304-F. Unpublished stud*y prepared by Midwest Research,
Institute. 60 p.
Wise, J. (1 993) Chlorpropham-Product Chemistry Preliminary Analysis,
Certification Limits and Enforcement Analytical Method: Lab Project Number
4075-92-045 l.AS-001: 4075-92-045 1-AS: 4075-92-0486-AS. Unpublished
study prepared by John Wise & Associates, Ltd. and Ricerca, Inc. 275 p.
. - ' ' - - "" - . :' ' f . , ' "'.
Sweetapple, G,(1993) Chlorpropham: Thermal andlmpact Explodability: Lab
Project Number: 4293 -92-041 9- AS-00 1 : 4293 -92-04 19-AS. .Unpublished
study prepared by Ricerca, Inc. 30 p. - v
Sweetapple, G. (1993) Chlorpropham-Corrosion Characteristics: Lab Project "
Number: 4075-92-Q472-AS : 4075-92-0472-AS-OO 1 . Unpublished study
prepared by Ricerca, Inc. 32 p.
85
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BIBLIOGRAPHY
MRID
CITATION
42822602 Lorence, P. (1993) Chlorpropham-Preliminary Analysis: Lab Project Number:
4293-92-0410-AS: 4293-92-0410-AS-001. Unpublished study prepared by
Ricerca, Inc. 71 p.
42823001 Lorence, P. (1993) Chlorpropham-Storage Stability (90-Day Accelerated): Lab
Project Number: 4075-93-0048-AS-001: 4075-93-0048-AS. Unpublished
study prepared by Ricerca, Inc. 48 p.
<"
42855101 Lorence, P. (1993) Chlorpropham-Octanol/Water Partition Coefficient: Lab
Project Number: 4293-92-0416-AS: 4293-92-0416-AS-001. Unpublished
study prepared by Ricerca, Inc. 52 p.
42855102 Malone, S. (1993) Chlorpropham-Stability: Lab Project Number:
4293-92-0417-AS: 4293-92-0417-AS-001. Unpublished study prepared by
Ricerca, Inc. 54 p.
42864501 Lorence, P. (1993) Chlorpropham-Methods Validation: Lab Project Number:
4293-92-0411-AS-001: 4293-92-0411-AS. Unpublished study prepared by
Ricerca, Inc. 55 p.
42864502 Lorence, P. (1993) Chiorpropham-Vapor Pressure: Lab Project Number:
4293-92-0414-AS-001: 4293-92-0414-AS. Unpublished study prepared by
Ricerca, Inc. 71 p.
42873601 Szollosi, B. (1993) Chlprpropham--Preliminary Analysis: Report Amendment:
Lab Project Number: 429,3-92-0410-AS-OOJ.. Unpublished study prepared by
Ricerca, Inc. 10 p.
42915101 Wise, J. (1993) Response to EPA's Review of July 22, 1993 MRID No:
42796301: (Chloro IPC Technical Product Chemistry). Unpublished study
* prepared by John Wise & Associates, Ltd. 17 p.
42958301 Haws, R.; Goodrick, B.; Walker, G.; et al. (1993) Addendum 1 to Report
92CIPC08: Determination of Storage Stability of Field-Incurred Residues of
Chlorpropham and Metabolites of Concern in or on Fresh, Stored and
Processed Potatoes: Lab Project Number: 92CIPC08. Unpublished study
prepared by Univ. of Idaho Analytical Lab. 91 p.
42966001 Sweetapple, G. (1993) ChlorprophamCorrosion Characteristics: Lab Project
Number: 4293-92-0420-AS-001. Unpublished study prepared by Rieerca, Inc.
31 p. ;
,86
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MRID
BIBLIOGRAPHY
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43053601
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Goodrick, B.; Haws, R.; Moller, G. (1993) Determination of Storage Stability
of Fortified Residues of Chlorprophafn and Metabolites of Concern in/on
Fresh, Stored, and Processed Potatoes: Lab Project Number: 93C.IPC02
Unpublished study prepared by University of Idaho Analytical Lab. 273 p.
Dewitt, R.; Lorence, P: (1994) Chlorpropham: Storage Stability (1-Year
Ambient): Lab Project Number: 4075/92/0447/AS: 4075/927 0447/AS/OOl.
Unpublished study prepared by Ricerea, Inc. 46 p.
87
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\
UNITED STATES ENVIRONMENTAL PROTECTfON AGENCr
' . ' ; WASHINGTON, D.C. '' 2O46O '
GENERiejDATA CALL-IN NOTICE
ortict or
' PBEVUmON, P6MIC1DM
AMD TOXIC AUMTA1O4
CERTIFIED MAIL
.Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 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(s). Within 90 days after you receive this Notice you must
respond as set.forth in Section III below: Your response must state:
1.
2.
3.
how you will comply with the requirements set forth in this. Notice and its Attachments
1 through 4; or,
why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Reeistrant'sJlesponse Form, (see section III-B)-
or, , " . ..'..''.. ., -.' ' . " . ... , , ; '";
why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section III-D). N
If you do not respond to this Notice, or ifyou 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. Data Call-in Response Form as well as a
list of all registrants who were sent this Notice (Attachment 4).
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
-89
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information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 3-31-96)
This Notice is divided into six sections and five 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 n
Section m
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:
Attachment 1 -
Attachment 2 >
Attachments -
Attachment 4 -
Data Call-In Chemical Status Sheet
Data Call-In Response Form
Requirements Status And Registrant's Response Form
List Of All Registrants Sent This Data Call-In Notice
SECTION! 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 ingredients). You have been sent this Notice because you
have product(s) containing the subject active ingredient(s).
SECTION H. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in Attachment 3. Requirements
Status and Registrant's Response Form. Depending on the results of the studies required
in this Notice, additional testing may be required.
90
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B: SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form, within
the time frames provided.
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 (tel-
703-487-4650)..
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 ง
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 ง 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 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 160.3(a)(6)].
D REGISTRANTS RECEIVING PREVIOUS SECTION 3ft
ISSUED BY THE AGENCY '
NOTICES
Unless otherwise noted herein, this Data Gall-fa does not in any wav supersede nr
change the requirements of any previous Data Call-InfsV 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. , .
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTTCF.
A. SCHEDULE FOR RESPONDING TO THE AGENCY
.9.1
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The appropriate responses initially required by this Notice 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.
B.' OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose 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 data requirements of this
Notice is contained in Section ffl-C. A discussion of options relating to requests for data
waivers is contained in Section ffl-D.
i
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form (Attachment 2) and the Requirements Status and Registrant's
Response Form (Attachment 3). The Data Call-In Response Form must be submitted as
part of every response to this Notice. 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 identified in Attachment 1.
1 - Voluntary Cancellation - You may avoid the requirements of this Notice
by requesting voluntary cancellation of your product(s) containing the active
ingredient(s) 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 the Data Call-In Response Form. If you choose this option, this is the only form
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.
92
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2- Use Deletion - You may avoid the requirementsof 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, 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 on the Requirements
, Status and Registrant's Response Form. You must also complete a Data Gall-In
Response Form bv signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (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, must bear an amended label.
3- 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(s) if the active ingredients) in the
product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). JEPA 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:
a. The active ingredients) in your registered product must be present
solelv. because of .incorporation of another registered product which
contains the subject-active ingredient(s) and is purchased from a source not
connected with you; and,
b. everv^ registrant who is trie ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. 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; Attar.hmRnt 9 and all supporting documentation.
The Generic Data Exemption is item number 6a on the Data Call-In Response
Forni. 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 product specific data.
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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 the requirements or are no longer in compliance with this
Data 'Call-In Notice, the Agency will consider that both they and you are not in
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.
4. Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the data requirements of this Notice. These options are
discussed in Section HI-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and option 6b and 7 on the
Data Call-In Response Form. If you choose option 6b or 7, you must submit both
forms as well as any other information/data pertaining to the option chosen to
address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D of
this Notice and are covered by options 8 and 9 on 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
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), 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, "RegistrantResponse." 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),
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4.
6.
I am submitting an existing study that has not been submitted previously
to the Agency by anyone (Submitting an Existing Study),
I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
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 deadlines 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 GFR Part 160), be conducted according to the
Pesticide Assessment Guidelines (PAG), and be in conforaiance 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 anH/nr footnotes to the form. If you wish to use a
protocol which differs from the options discussed in Section H-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 H-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! A 90-day progress report must be
submitted for all studies. 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
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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
Forni 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).
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 requirefnent(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 ah 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
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discretion not to suspend your registration's), although you do not comply with
the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will hot 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
registrants) developing the data has refused to accept your 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. .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 the burden of producing, the data
upon terms to be agreed or failing agreement to be bound by binding arbitration
as provided by FIFRA 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.
E2SS- 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 burdens 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 subjectito suspension, your registration as well as that of the other
registrant will normally he 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
thedata. - , ; ...-.'!..-,..:.. s ...'...,.-. . .'..:/-'","'.
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 Jhat the study is not
acceptable, the Agency will require you to comply with this Notice, normally
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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 CFRPart 160. As stated in 40 CFR 160.3(7)" 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 data
may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded
data from automated instruments." The term "specimens", according to 40
CFR 160.3(7), means "any material derived from a test system for
examination or analysis "
b. 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 GFR Part 160. Registrants must also
certify at the time of submitting 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.
c. 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 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
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believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It lias been the Agency's experience that
* studies completed prior to January 1970 rarely satisfied the purpose of the
PAG and that necessary raw, data are usually not available for such studies.
If you submit an existing study, you must certify that the study '
irieets 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
.w,hich 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 hot in the Agency's files, you
must submit a summary and copies as required by PR Notice 86-5.' :
Option 5. Upgrading aStudy -
If a study has been classified as partially acceptable and upgradeable you
may submit data to upgrade that study. The Agenpy 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
c assified 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 theMRID 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.
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This option should also 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 8570-31, Certification with
Respect to Data Compensation Requirements. .
D. . REQUESTS FOR DATA WAIVERS -
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 inapplicable and do not apply to your product.
1- Low Volume/Minor Use Waiver ~ Option 8 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 as low volume
pesticides only those active ingredient(s) 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(s) is used
' ! (
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for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) 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(s) 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 fpr a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-dav
response to ttos Notice: ;
a. Total company sales (pounds and'dollars) of all registered
, produces) containing the active ingredient(s); If applicable to the active
mgredient(s), 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.^ '.,..',.
b. Provide an estimate of the sales (pounds and dollars) of the active
mgredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product(s) containing the active
mgredient(s) 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.
- d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s)
by year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. 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
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f. 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.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of produces)
containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active
ingredients) to users. Discuss the use patterns and the effectiveness of the
active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon whicfrto 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(s) in terms
, of its benefits, you should provide information on any of the following
factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts
on the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) 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. ' ;
*
2. Request for Waiver of Data Option 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 corresponding use is no
longer registered or the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You must
also 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. , .. ,
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You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of. this Notice do not apply to your
product(s), you will not be required to, supply the data pursuant to section
3fc)(2)(B). If EPA determines that the data are required for vour product s)1 yon
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 thp nptirm
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTTrF
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:
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
a study as required by this Notice.
1.
on
5.
6.
7.
Failure to submit on the required schedule acceptable data as required bv
this Notice. ' , , J'
' '' "-.''*..-
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. .
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8. 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:
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: or,
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.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
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 Daja 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
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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. :; "
C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
_ EPA has statutory authority to permit continued sale, distribution and use of
existingstocks of apesticide product which has been suspended or cancelled if doing so
Rodenticide 8*6111 Whh ^ PUrPฐSeS ฐf the Fedqral ^s^cide, Fungicide, and
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 would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
produces) 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 must also explain why an
existing stocks" provisions 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.
XT*- ; 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 tSe stocks are exhausted Any sale
distribution^ or use of stocks of voluntarily cancelled products containing an active
ingredient(sKor which the Agency has particular risk concerns will be determined on
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 Agencv
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
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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.
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 listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form (Attachment 2) and
a completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-in Response Form 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 Rossi, Division Director
Special Review
and Reregistration Division
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Chlorpropham DATA CALL-IN CHEMICAL STATUS:SHEET ,
INTRODUCTION ' : s /
You have been sent this Generic Data. Call-In Notice because you have product(s)
containing Chlorpropham.
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 Chlorpropham.
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 Compensation
Forms in replying to this Chlorpropham Generic Data Callln (Attachment F). Instructions and
guidance accompany each form..
,_ f , , . ' ''--. "' "'."'' " "'"
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for
Chlorpropham are contained in the Requirements Status and Registrant's Response. Attachment
C. The Agency has concluded that additional product chemistry data on Chlbrpropham are
needed. These data are needed to fully complete the reregistration of all eligible Chlorpropham
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 Margery Exton at (703) 308-8024.
All responsades to this Notice for the generic data sequirements should be submitted to:
. Margery Exton, Chemical Review Manager
Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticiafde Programs
U.S. Environmental Protection Agency ' ;
Washington, D.C. 20460 ' -
RE: Chlorpropham . -
107
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SPECIFIC INSTRUCTIONS FOR THE GENERIC tiATA CALL-IN RESPONSE FORM
This Form is designed tp be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this, form each time you are responding to a data call-in for which EPA
has sent you the form .entitled "Requirements Status and Registrant's Response."
Items 1-4 will 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,
j .'.""- - -
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 suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, 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, DC 20503. " '
INSTRUCTIONS
Iteni 1.
Item 2.
. Item 3.
Item 4.
Item 5.
This item identifies your company name, number and address.
This 'item identifies the ease number, ease name, EPA chemical number
and chemical name. . '
This item identifies the date and type of data call-in.
.'.- ' . .- . '.. '
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.
Cheek 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. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled. ,
109
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Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if 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
that some of your sources are registered), you may not claim ,a Generic
Data Exemption and you may not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in 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.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form that indicates
how you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP)
as indicated in Item 3 and if your product is an end use product for which
you agree to supply product-specific data. Attach the Requirements Status
and Registrant's Response Form that indicates how you will satisfy those
requirements.
Item 8. 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. Enter the date of signature.
110
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Item 10. Enter the name of the person EPA should contact with questions regarding
your response. . '_ -
Item 11:..- Enter the phone number of your company contact. .
111
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data , ,
'This form is designed to be used for registrants to'respond to call-in- for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data5 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. These instructions are .for completion of generic data
requirements. . . ,- '
EPA has developed this form individually for each data call-in addressed to each registrant, and
has preprinted mis form with a number of items, DO NOT use this form for any other active
ingredient. -
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly. ~
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 .suggesting for reducing this burden, to Chief, Information Policy Branch,
PM-223, 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. -,. ..-.-.' -
INSTRUCTIONS * ^
Item 1. This item identifies your company name, number, and address.
Item2. This item identifies the case number, case name, EPA chemical number and
chemical name. '
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
113
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Item 5.
Item 6.
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.
This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
O.
Terrestrial food
Terrestrial feed
Terrestrial non-food ,
Aquatic food
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
Indoor non-food
Indoor medical
Indoor residential
Item 7.
This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP
MP
MP/TGAI
PAI
PAI/M
PAtyPAIRA
PAIRA
PAIRA/M
PAIRA/PM
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade
Active Ingredient
Pure Active Ingredient .
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure Active Ingredient
Radiolabelled . *
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
114
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TEP
TEP_*
TEP/MET
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TGAI/PAIRA
TGAI ,
TGAI/TEP
TGAI/PAI
MET
IMP
DEGR
./
*See: guideline comment
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified ' .
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient
i and Metabolites
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled ;
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Typical
End-Use Product
Technical Grade Active Ingredient or Pure Active
Ingredient
Metabolites
Impurities
Degradates
Item 8.
Item 9.
This item identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-In Notice.
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.
1.
(Developing Data) Twill 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 protocol and progress,reports required in
item 5 above. _ .
(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: .-.' ' : ..'.-' . . . ' /".'
(Offer/to Cost Share) I have made anjoffer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offerto Cost Share in the Development of Data"
115
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9.
that describes this offer/agreement. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
making an offer to share in the cost of developing data as outlined in the
Data Call-In Notice.
(Submitting Existing Data) I am submitting an existing study 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.
(Upgrading a Study) I am submitting or citing 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
Number (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.
(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. I am providing the Agency's
classification of the study.
(Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
(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.
(Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other things,
all information required to support the request. I understand that, unless
116
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modified by the Agency in writing, the data requirement as stated in the
Notice governs. , '
Item 10. This item 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. Enter the date of signature. .
Item 12. Enter the name of the person EPA should contact with questions regarding your
response :
Item 13. Enter the phone number of your company contact.
117
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V
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C . 2046O
onict or
pBsvnno*.
ADD TOJUC
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 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific 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 9t) days after you receive this Notice
you must respond as set forth in Section IE below. Your response must state:
1 .
2.
3.
How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or .
Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3 , , Requirements Status and Registrant's Response Form, (see
section IH-B); or
Why you believe EPA should n9t require your submission of product specific
data in the manner specified by this Notice (see section in-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
127
-------
your produces) 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. Data Call-in Response Form as well
as a list of all registrants who were sent this Notice (Attachment 6).
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 03-31-96). ' '
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 - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section HI- Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects . .
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 -
2 -
3 -
4 -
5 -
6 -
Data Call-In Chemical Status Sheet -
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms
SECTION! WHY YOU ARE RECEIVING THIS NOTTCF.
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional'
generic data requirements are being imposed. You have been sent this Notice because you have
produces) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
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The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional 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
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
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 Ae National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va22161 (tel: 703-487-4650)., ,
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 ง 1 58.70). 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 ง 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 [40ปCFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3 (c)(2VB} 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-InCs"). or anv 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,
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE ,
III- A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific date must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
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adequately respond to this Notice within 90 days of yo'ur 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.
HI-B. OPTIONS FOR RESPONDING TO THE AGENCY
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 chose 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 HI-C. A discussion of options
relating to requests for data waivers is contained in Section ffl-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-In Response Form, and the Requirements Status and Registrant's Response Form
Attachment 2 and Attachment 3. 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 must be submitted for each product listed on the Data Call-in Response Form
unless the voluntary cancellation option is selected or unless the product is identical to another
(refer to the instructions for completing the Data Call-in Response Form in Attachment 2).
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.
* 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 the Data Call-in Response Form If you choose this option, this is the only form
that you are required to complete.
If you chose 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.
2- 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 HI-C of this Notice and comprise options 1 through 6 on the
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Requirements Status and Registrant's Response Form and item numbers 7a^and 7b on the Data
Call-In Response Form. Deletion of a use(s) and the low volume/minor .use option are not valid
options for fulfilling product specific data requirements. : ' . ".. , ' - '..,'.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section HE-D of this Notice and are covered by option 7 on 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 inforrnation/data pertaining to the option chosen to address the
data requirement. , ; .
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
- ' . ' ' -- . ' _ . - ' \ - ' .' .
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the,
product specific data requirements (i.e. you select:item number 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: .
-' ' ' ' ' . ' ' . ,.,.- ^ . : ^ . . - - .- - ^ , . r' -""'" \ ป.'_'.
(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) ' ' '_ '
" - ' -.::' N " '
Option 1. Developing Data If you choose to develop the required data it must be in
conformance with Agency deadlines 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.
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. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data" are not
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submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
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 *bn 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 ~ 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 registratibn 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. 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 ~ This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. 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 do 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 your 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 7. In addition, you must demonstrate that the other registrant to whom the offer was
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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 the burden of producing
the data upon terms to be agreed or failing agreement to-be bound by binding arbitration as
provided by FDFRA 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 burdens 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 will normally 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; . '.','''."" '-'. v - " '. " "'.'.''% ''.'; .
.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 CFRPart
160: As stated in 40 CFR 160.3(j) " 'raw data1 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 data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from automated
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instruments." The term "specimens", according to 40 CFR 160.3(k), means "any
material derived from a test system for examination or analysis."
b. 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 must also certify at the time of
submitting 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
c. 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
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 are usually 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 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 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 - 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
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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. x
This option should also 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 pf 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 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.
* . ,'...., . - s. ... , '
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31-. Certification with Respect to Data
Compensation Requirements. .
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, as appropriate
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for produpt 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 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 extraordinary circumstances. You should also be aware that
. ' ' - , " . . ."-". '135 " ' .'.' : " "" '-""
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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.
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. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. 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.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. 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).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section IH-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. 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:
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:
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b.
fulfill the commitment to develop and submit the data as.required by this
Notice; or .'.>.'"'' ..'. ' '.' ":' ' ' .- ' '.'...'..
9:
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
ofany.changes.requiredby 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. ,
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 would generally 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
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clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also 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 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.
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 ' .
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and.a completed
Requirements Status and Registrant's Response Form:(.Attachment 2 anH Attadhmpnt ^ fXr
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 Data Call-In Response Form need be submitted *
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
1 -
2 -
' 3 -
4 -
-5,. -
6 -
Data Call-in Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form .
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CHLORPROPHAM DATA CALL-IN CHEMICAL STATUS SHEET -
INTRODUCTION , .
You have been sent this Product Specific Data Call-in Notice because you have product(s)
containing Chiorpropham. ;, ".'.'..
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
Chlorpropham, 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 DCI (Attachment 6)" and
(7) the Cost Share and Data Compensation Forms in replying to this Chlorpropham Product
Specific Data CalWn (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Chlorpropham are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on Chlorpropham 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 Chlorpropham 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 JeamHolmes at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be
submittedto: _ , , ,
Jean Holmes "
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: Chlorpropham
141:
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., INSTRUCTIpNS EOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
, Item 1-4. , Already completed by EPA. '
ItemS.
Item 6.
Item 7a.
If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice
and you will not have to complete any other forms. Further sale and distribution
of your product after the effective date of cancellation must be in accordance with
the Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data
exemption, you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this
form, provide the EPA registration numbers of your source(s); you would riot
complete the "Requirements Status and Registrant's Response" form. Examples
of such products include repackaged products and Special Local Needs (Section
24c) products which are identical to federally registered products.
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." 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.
See Item 6 with regard to Identical products and data exemptions. -
Items 8-11. Self-explanatory.
NOTE:
You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. Forexample, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct
143
-------
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3
Item 4.
ItemS.
Item 6.
Item 7.
Item 8:
Item 9.
Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 iij product chemistry are now listed under 40 CFR
158.155 through 158.180, SubpartC.
The study title associated with the guideline referenqe number is identified.
The use pattern(s) of .the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements, all
use patterns are covered by the data requirements. In the case of efficacy data, the
required studies only pertain to products which have the use sites,and/or pests
indicated.
The substance to be tested is identified by EPA. For product specific-data, the,
product as formulated for sale and distribution is the test substance, except in rare
cases.
The due date for submission of each study is identified. It is normally based on
8 months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary. , ,
Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this
table. Fuller descriptions of each option are contained in the Data Call-In Notice.
I will generate and submit data by the specified due date (Developing Data). 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. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand
that this option is available only for acute toxicity or certain efficacy data: and only
145
-------
if EPA 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. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29)
and (2) two completed and signed copies of the Confidential Statement of
Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA 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 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 also submitting a
completed "Certification of Offer to Cost Share in the Development Data"
form. 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 (Section ffl-C.l.) apply as well. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA
Form 8570-4).
4. By the specified due date, I will submit an existing study that, has not been
submitted previously to the Agency by anyone (Submitting an Existing Study).
I certify that this study will meet all the requirements for submittal of existing data
outlined in Option 4 in the Data Call-In Notic* (Section III-C. 1.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along, with this response. I also certify
that I have determined that this study will fill the data requirement for which I
have indicated this choice. By the specified due date, I will also submit a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) to show what data compensation
option I have chosen. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I
will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
146
-------
7.
Accession number of the study at the due date. I understand that the conditions
for this option outlined Option 5 in the Data Call-In Notice (Section III-C.l.)
apply. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies, of the
Confidential Statement of Formula (EPA Form 8570-4).
By the specified due date, I will cite, an existing study that the Agency ha:,
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand -[that this option is available only for acute toxiciry
or certain efficacy data and only if the cited study was conducted on my product,
an identical product or a product which EPA 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) for the cited data on a "Product Specific Data Report"form
or in a similar format. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
I request a waiver for this study because it is inappropriate for my product
(Waiver Request). 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
and Registrant's Response" Form indicating 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. By the specified due date, I will also submit: (1) a
completed "Certification, With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE:
You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
147
-------
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
148
-------
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In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxi.city data requirements for reregistration of products containing the active ingredient
chlorpropham (Isopropyl Nr(3-chlorbphenyl) carbamate), the Agency has batched products
that 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), type of formulation (e.g,, liquid, Avertable powder, .aerosol, granular, etc.),
and labeling (e.g., signal word,, use classification, precautionary labeling, etc.). Note that the'
Agency is not describing batched products as "substantially similar" since some products
within a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the
right to require, at any time, acute toxieity date for an individual product should the need
arise/..;.. " ' . ' , ...''..: .'.,.,........-.., , ." ..-. .' ' > ;..
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batchy or to general all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxieity data, he/she
may do so if the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by the Agency to be similar for acute toxieity,
and the formulation has not been significantly, altered since submission and acceptance of the
acute toxieity data. Regardless of .whether new data is generated or existing data is
,. referenced, registrants must clearly identify the test material by it's EPA Registration Number.
If more than one confidential statement of formulation (CSF) exists for a product, the
registrant must indicate the formulation actually tested by identifying the corresponding CSF.
: .''-.- ',- ".,...ซ. ' ; ' ' '.. .'
In deciding how to meet the product specific data requirement, registrants must follow
the directions given in the Data Call-in Notice and its attachments appended^ the RED. The
DCI Notice contains two response forms that 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 toxieity 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
.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, thexchoices are Options 1,4,5, or 6.
However, a registrant should know that choosing not to participate in a batch does not
155
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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 chlorpropham.
Table X
Batch
1
2
3
4
EPA Reg, No,
2749-102
2749-117
2792-67
2749-70
34704-613 .
CA93000800
DC90000100
DE91000100
MD91000800 .
NJ91001200
OR91001200
VA91000400
2749-264
2792-41
ND82002100
OR85004700
WA82006500
34704-614
65726-1
WA82007600
WA92004100 '
Active Ingredient
" > /
chlorpropham ...98.0%
chlorpropham ...98.0%
chlorpropham ...98.0%
chlorpropham ...36.0%
chlorpropham ...36.0%
chlorpropham ...36.0%
chlorpropham ...36.0%
chlorpropham ...36.0%
chlorpropham ...36.0%
chlorpropham ...36.0%
chlorpropham ...36.0%
chlorpropham ...36.0%
chlorpropham ...46.5%
chlorprophanr...49.65%
chlorpropffam ...46.5%
chlorpropham ...46.5%
chlorpropham ...46.5%
chlorpropham ...78.5%
chlorpropham ...78.6%
chlorpropham ...78.5%
chlorpropham ...78.5%
Formulation
TซJ0
solid
solid
solid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
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Table 2 lists the product the Agency was unable to batch; These products were either
considered not to be similar to other products for purposes of acute toxicity or the Agency
lacked sufficient information for decision malting. The registrants of these products are
responsible for meeting the acute toxicity data requirements for these products.
Table 2
J,
EPARes*N0.
2792-40
34704-612 . ,
ND85000900 ,. '
Active Ingredient
chlorpropham...25%
chlorpropham...46%
chlorpropham. . . 78.4 1 %
Formulation Type
liquid
liquid
liquid
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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.
V
c. The CSF must be signed, dated and the telephone number of the responsible
party must be provided.
d. All applicable information which is on the product specific data submission
must also he 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.
158
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n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation, ' .. ,
-.1 159'
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161
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&EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-01 OS
" 2070-0057
Approval Expires 3-31-96
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, PM-223. U.S. Environmental Protection Agency, 401 M St.. S.WV 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 .
Product Nume ,
Company Number
EPA Reg. No.
j Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide.and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of develooina
data.. ' . ";."' ~"..-. .:" -
My firm has offered in writing to enter into such an agreement.; That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) 6f FJFRA if final agreement on all
terms could not be reached otherwise. This .offer was made to the following firm(s) on the following
date(s): , .
Nam* of Flrm(ป)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are tiue, 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'* Authorized Rapre**ntatlve
Date
Nam* and Title (Plea*e Type or Print)
EPA Form 8570-32 (5/91) Replaces KV.\ Form 8580, which is obsolete
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions,,search ing 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 cpllection 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 . '-'-:-'':
Product Name . -
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal insecticide, Fungicide and Rodenticide Act
[FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study. .
2. That for each study cited in support of registration or reregistration under FIFRAthat is NOT an exclusive use study, I am the
ariginal data submitter; or I have obtained the written permission of the original data submitter, or I have notified in writing the
:ompany(ies) that submitted data I have cited and have offered.to: (a) Pay compensation for those data in accordance with sections
3(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
equirement of FIFRA and the amount of compensation due, if any. The companies I have notified are (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or.indicated on the attached
'Requirements Status and Registrants'Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
eregistration under FIFRA. :
Signature ' / " ...
Date
Jams and Title (Please Type or Print).
3ENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
eregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
ignature , , ' ' ' .
Date
lame and Title (Please Type or Print)
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1 The Following is a list of available documents for Chlorpropham that my further assist
you in responding .-to this.Reregi strati on Eligibility ;;bebisipn'document. These documents
may be obtained by the following methods: -v ', "
Electronic ' :
File format:: Portable Document Format .(.PDF) Requires Adobeฎ Acrobat or compatible ,
readen Electronic copies can be downloaded from the Pesticide Special-
Review and Reregistration Information System at 703-308-7224. They also are
, ' available on the Internet on EPA's gopher server, GOPHER.EPA GOV, or
using ftp on FTP.EPA.GOV, or using WWW (World Wide W;eb) on
.WWW.EPA.GOV., or contact Jean Holmes at (703)-308-8008. ,
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 Chlorpropham.
! The,following documents are part of the Administrative Record for Chlorpropham and
may included in the EPA's -Office of Pesticide Programs Public Docket Copies of these
documents are not available electronically, but may be obtairied by contacting the person
listed on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters, , -
_ ....
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