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-------
APPENDIX C
Chlorinated Isocyanurates Bibliography
Citations Considered to be Part of the Data Base Supporting
the Reregistration of the Chlorinated Isocyanurates
-------
-------
GUIDE TO APPENDIX C
CONTENT 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, will be 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unpublished materials submitted to the Agency the Agency has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 attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by Master Record Identifier," or MRID
number. This number is unique to the citation, and should
be used at any time specific reference is required. It is
not related to the six-digit "Accession Number" which has
been used to identify volumes of submitted studies; see
paragraph 4(d)(4) below for further explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all MRID entries. This
temporary identifier 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
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the Agency could confidently identify
one, 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
author. As a last resort, the Agency has shown the
first submitter as author.
-------
b. Document date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark the bibliographer deduced the date
from evidence in the document. When the date appears
as (19??), the Agency was unable to determine or
estimate the date of the document.
c. Title. In some cases, it has been:necessary for Agency
bibliographers to create or enhance a document title.
Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to" any self-explanatory text) the
following elements describing the earliest known
submission:
(1) Submission date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." 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," standing 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.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
-------
APPENDIX C
Chlorinated Isocyanurates Bibliography
_ _ citation
00019383 LeBlanc, G.A. (1976) Trichloro-s-triazinetrione: Acute
Toxicity of ACL-85 to "Daphnia_magna '#.
(Unpublished study received Aug 10, 1977 under
230-50; prepared by EG&G, Bionomics for Monsanto
Co., submitted by FMC Corp., Industrial Chemical
Group, Philadelphia, Pa.; CDL: 231918-H)
00026193 McCann, J.A. ; Pitcher, F.G. (1973) $Camp Rapid Algae
Cure: Toxicity to RainBow Trout/: Test No. 555.
(U.S. Environmental Protection Agency, Pesticides
Regulation Div. , Agricultural Research Center,
Animal Biology Laboratory, unpublished report) .
00026195 McCann, J.A. ; Pitcher, F.G. (1973) $Spot-Out: Toxicity
to Rainbow Trout/: Test NO. 583. (US Environmental
Protection Agency, Pesticides Regulation Div.,
Agricultural Research Center, Animal Biology
Laboratory, Unpublished report.)
00056478 Hu, H.C. (1981) Hydrolysis Study of Aqueous Sodium
Salt Solutions of 2 , 4 , 6-Trihydroxy-l, 3 , 5-triazine.
(Unpublished study received Jan 26, 1981 under
unknown admin, no.; prepared by FMC CORP.,
submitted by Monsanto Co., Washington, DC; CDL
244259-A)
00063477 Rajasekaran, D. ; Biava, C.; Thorstenson, J.H.; et al.
(1981) 13-week Toxicity Study in Rats: IRDC No.
167-151. (Unpublished study received Apr 9, 1981
under unknown Admin. No.; prepared by California,
San Francisco Medical Center, submitted by
Monsanto Co., Washington, DC,; CDL: 244797-A)
00091031 Sharraa, R. (1981) An Evaluation of the Mutagenic
Potential of Sodium Cyanurate Using the in-vivo
Rat Bone Marrow Cytogenetic Assay: SRI Project
LSC-2923, Task 2; Monsanto Study No. SR-80-522.
Final rept. (Unpublished study received Jan 4,
1982 under 524-107; prepared by SRI International,
submitted by Monsanto Co., Washington, D.C.
CDL:246547-A)
-------
APPENDIX C
Chlorinated Isocyanurates Bibliography
MRIP
Citation
00094882 Stewart, B.E. (1981) An Evaluation of the Effect of
Monosodium Cyanurate on Sister Chromatid Exchange
Frequencies in Cultured Chinese Hamster Ovary
Cells: SRI Project LSC-2923,!Task 1. Final rept.
(Unpublished study received Feb 17, 1982 under
1528-984; prepared by SRI International, submitted
by Oli'n Corp., Stanford, Conn. , CDL: 246826-A)
00094883 Kirby, P.E.; Pizzarello, R.F.; Brauninger, R.M.; et
al. (1981) Evaluation Test Article Cyanuric Acid
(Sodium Salt) (MRI #582) for Mutagenic Potential
Employing the L5178Y TK+/- MUtagenesis Assay:
Study No. 013-312-582-7. (Unpublished study
received Feb. 17, 1982 under 1258-984; prepared by
EG&G Mason Research Institute, submitted by Olin
Corp., Stanford Conn,; CDL: 246826-B)
00105168 Schardein, J.; Laughlin, K.; Blair, M. (1982)
Teratology Study in the Rat with Monosodium
Cyanurate: 167-159. (Unpublished study received
June 11, 1982 under unknown admin, no.; prepared
by International Research and Development Corp.,
submitted by Monsanto Co., Washington, DC; CDL:
247700-A)
00124782 Serota, D.; Fezio, W,; Hepner, K.; et al. (1982)
Thirteen-week Toxicity Study in Mice: Monsodium
Cyanurate: Project No. 2169-100. Final rept.
(Unpublished study received Jan 6, 1983 under 524-
107; prepared by Hazleton Laboratories America,
Inc., submitted by Monsanto Co., Washington, DC;
CDL: 249192-A)
00126361 Monsanto Co. (1983) Two Year Oncbgenicity Study in
Mice: $Cyanurate/. (Unpublished study received
Feb. 17, 1983 under 524-107; CDL:249688-B)
00126362 Blair, M.; Jefferson, N.; Geil, R. (1982) Chronic
Toxicity and Oncogenicity Study in Rats: $S-
Triazinetriol/: 167-157. (Unpublished study
received Feb 17, 1983 under 524-107; prepared by
International Research and Development Corp.,
submitted by Monsanto Co., Washington, DC; CDL
249688-C) . \
-------
APPENDIX C
Chlorinated Isocyanurates Bibliography
Citation
00128287
00131014
00132426
00132427
00132510
00132603
Chadwick, M. / Hayes, D.; McComish, M. ; et al. (1982)
Disposition and Metabolism of 14C- labeled Sodium
Cyanurate in Dog: C-86329. (Unpublished study
received Apr. 29, 1983 under 524-107; prepared by
Arthur D. Little, Inc., submitted by Monsanto Co.,
Washington. DC; CDL; 250097-A)
Chadwick, M, ; Hayes, D. ; Branfman, A.; et al. (1983)
Disposition and Metabolism of 14C-labeled Sodium
Cyanurate in Rat: C-86329. Rev. (Unpublished
study received Aug 29, 1983 under 524-107;
prepared by Arthur D. Little, Inc., submitted by
Monsanto Co., Washington, DC; CDL: 251124-A)
Fink, R. (1975) Eight-day Dietary LC50--Mallard Duck:
ACL 85: Trichloro-s-triazinetrione: Project No.
139-113. Final rept. (Unpublished study received
Oct 12, 1983 under 230-47; prepared by Truslow
Farms, Inc., submitted by FMC Corp., Philadelphia
PA; CDL 251626-E)
Fink, R. (1975) Eight-day Dietary LC50~Bobwhite Quail:
ACL 85: Trichloro-s-triazinetrione Project No.
139-112. Final rept. (Unpublished study received
Oct 12, 1983 under 230-47; prepared by Truslow
Farms, Inc., submitted by FMC Corp., Philadelphia,
PA; CDL: 251626-F)
Consultox Laboratories, Ltd. (1974) Monosodium
Cyanurate Teratogenicity Study in the Rabbit: CL
73: 101: 899. (Unpublished study received Oct 12,
1983 under 230-47; submitted by FMC Corp.,
Philadelphia, PA; CDL: 251642-A)
Fink, R. (1976) Acute Oral LD50~Mallard Duck: ACL-85:
Trichloro-s-triazinetrione: Project NO. 139-120.
Final rept. (Unpublished study received Oct 12,
1983 under 230-47; prepared by Wildlife
International, Ltd., submitted by FMC Corp.,
Philadelphia, PA; CDL: 251626-G)
-------
APPENDIX C ;
Chlorinated Isocyanurates Bibliography
HRID Citation
00144301 Beavers, J. (1984) A Dietary LC50 Study in the Mallard
with Trichloroisocyanurate Acid: Final Report:
Wildlife International Ltd. Project No. 201-105.
Unpublished study prepared by Wildlife
International Ltd. 14 p.
00144302 Beavers, J. (1984) A Dietary LC50 Study in the Bobwhite
with Trichloroisocyanurate Acid Final Report:
wildlife International Ltd. Project No: 201-104.
Unpublished study prepared by Wildlife
International Ltd- 14 p.
00150286 Schardein, J. (1985) Three Generation Reproduction
Study in Rats with Sodium Salt of Cyanuric Acid
(S-Triazinetriol): Final Report: Study No. 497-
001. Unpublished study prepared by International
Research and Development Corp. 981 p.
00150962 Robaidek, E. (1985) Avian Single-dose Oral LC50 (in)
Bob White Quail (Colinus virginianus):
{Trichloroisocyanuric Acid}: Final Report: Study
No. 6026-435. Unpublished study prepared by
Hazelton Laboratories America, Inc. -26 p.
00150963 Robaidek, E. (1984) Avian Dietary LC50 {in} Mallard
Duck (Anasplatyrhynchos): {Trichloroisocyanuric
Acid}: Final Report: Study NO. 6026-449.
Unpublished study prepared by Hazleton
Laboratories America, Inc. 15 p.
00150964 Robaidek, E. (1984) Avian Dietary LC50 (in) Bob Quail
(Colinus virginianus): {Trichloroisocyanuric
Acid}: Final Report Study No. 6026-425.
Unpublished study prepared by Hazleton
Laboratories America, Inc. 12 p.
00150965 Barrows, B. (1984) The Acute Toxicity Of TCCA/G
(Trichlorocyanuric Acid) to the Bluegill Sunfish,
Lepomis macreochirus, in a Static Test System:
Biospheric Project No. 84E/058BG. Unpublished
study prepared by Biospherics, Inc. 11 p.
-------
APPENDIX C
Chlorinated Isocyanurates Bibliography
MRID Citation
00150966 Barrow, B. (1985) The Acute Toxicity of
Trichlorocyanuric Acid (TCCA/G) to the Rainbow
Trout, Salmo gairdneri, in a Static Test System:
Biospheric Project No. 84E-058RT. Unpublished
study prepared by Biospheric, Inc. 11 p.
00150967 Barrows, B. (1985) The Static Acute Toxicity of TCCA/G
(Trichlorocyanuric Acid) to the Water Flea,
Daphnia magna Straus: Biospherics Project No.
84E-058DM. Unpublished study prepared by
Biospherics, Inc.11 p.
00154329 Surprenant, D., Hoberg, J. (1984) Acute Toxicity of
Trichloroisocyanurate to the Daphnids (Daphnia
nagma): Report BW-84-10-1668. Unpublished study
prepared by Springborn Bionomics, Inc. 13 p.
40046502 Richter, J. (1986) Product Chemistry Study:
Trichloro-S-Triazinetrione. Unpublished study
prepared by IMI - Institute for Research and
Development Ltd. and Fertilizers & Chemicals Ltd.
25 p.
40046503 Richter, J. (1986) Product chemistry Study:
Trichloro-S-Triazinetrione. Unpublished study
prepared by IMI - Institute for Research and
Development Ltd. and Fertilizers & Chemicals Ltd.
36 p.
40200401 Richter, J. (1986) Product Chemistry Study:
Trichloro-S-Triazinetrione: Supplement: Lab
Project: 3307/R4-1577. Unpublished compilation
prepared by Fertilizers & Chemicals Ltd. in
cooperation with IMI—Institute for Research &
Development, Ltd. 7 p.
40046502 Richter, J. (1986) Product Chemistry Study:
Trichloro-S-Triazinetrione. Unpublished study
prepared by IMI - Institute for Research and
Development Ltd. and Fertilizers & Chemicals Ltd.
25 p.
-------
MRID
APPENDIX C
Chlorinated Isocyanurates Bibliography
Citation
40046503 Richter, J. (1986) Product Chemistry Study:
Trichloro-S-Triazinetrione. Unpublished study
prepared by IMI - Institute for:Research and
Development Ltd. and Fertilizers & Chemicals Ltd.
36 p.
40200401 Richter, J. (1986) Product Chemistry Study:
Trichloro-S-Triazinetrione: Supplement: Lab
Project: 3307/R4-1577. Unpublished compilation
prepared by Fertilizers & Chemicals Ltd. in
cooperation with IMI—Institute for Research &
Development, Ltd. 7 p.
40046502 Richter, J. (1986) Product Chemistry Study:
Trichloro-S-Triazinetrione. Unpublished study prepared by IMI -
Institute for Research and Development Ltd. and Fertilizers &
Chemicals Ltd. 25 p.
40046503 Richter, J. (1986) Product Chemistry Study:
Trichloro-S-Triazinetrione. Unpublished study
prepared by IMI - Institute for Research and
Development Ltd. and Fertilizers & Chemicals Ltd.
36 p.
40200401 Richter, J. (1986) Product Chemistry Study:
Trichloro-S-Triazinetrione: Supplement: Lab
Project: 3307/R4-1577. Unpublished compilation
prepared by Fertilizers & Chemicals Ltd. in
cooperation with IMI—Institute for Research &
Development, Ltd. 7 p.
40351801 US Environmental Protection Agency (1984) Ambient Water
Quality Criteria for Chlorine - 1984. Office of
Water Regulations and Standards, Criteria and
Standards.Div. Available from NTIS, PB85-2274-
429.
-------
APPENDIX C
Chlorinated Isocyanurates Bibliography
MRID Citation
40414401 Doshida, A. (1987) Trichloroisocyanuric Acid—Product
Chemistry ...Product Identity and Composition:
Laboratory Project ID: 001/87. Unpublished
compilation prepared by Nippon Soda Co., Ltd. 43p.
40414402 Doshida, A. (1987) Trichloroisocyanuric Acid—Product
Chemistry ...Analysis and Certification of Product
Ingredients: Laboratory Project ID; 002/87.
Unpublished compilation prepared by Nippon Soda
Co., Ltd. 138 p.
40414403 Doshida, A. (1987) Trichloroisocyanuric Acid—Product
Chemistry ...Physical and Chemical
Characteristics: Laboratory Project ID: 003/87.
Unpublished compilation prepared by Nippon Soda
Co., Ltd. 95 p.
40802401 Todhunter,. J. (1988) Product Analysis Data and
Certification of Limits for Cdf Chimie's Oniachlor
90, Oniachlor 60, Oniachlor EC TICA Granular and
SDIC Granular: Project ID. CDF/PRODANAL.SUB.
Unpublished study prepared by Todhunter, Mandava,
and Assoc. 46 p.
40829001 Olin Corp. (1988) Description of Manufacturing
Processes; discussion of Composition and
Certification for: i. Trichloro-s-triazinetrione;
sodium dichloro-s-triazinetrione; sodium
dichloro-s-triazinetrione dihydrate. Unpublished
study. 15 p.
40879501 Nelson, G. (1988) Product Chemistry: ACL 90 Plus
Chlorinating Composition: Laboratory Project ID
MSL-8173. Unpublished study prepared by Monsanto
Co. 131 p.
40898501 Nelson, G. (1988) Product Chemistry: ACL 60 Chlorinating
Composition: Project ID: MSL-8201. Unpublished
study prepared by Monsanto Co. 58 p.
-------
APPENDIX C
Chlorinated isocyanurates Bibliography
MRID Citation
40898601 Nelson, G. (1988) Product Chemistry: ACL 56 Chlorinating
Composition: Project ID: MSL-8202. Unpublished
study prepared by Monsanto Co. '150 p.
40927401 Nelson, G. (1988) Product Chemistry: ACL 59 Chlorinating
Composition: Laboratory Project;ID MSL-8215.
Unpublished study prepared by Mbnsanto Co. 160 p.
40933103 Mandava, N.; Todhunter, J. (1988) Hi-Lite 60P ...:
Product Chemistry: Physical and!Chemical
Characteristics and Other Requirements.
Unpublished study prepared by Nissan Chemical
Industries Ltd. 27 p.
40933104 Mandava, N.; Todhunter, J. (1988) Hi-Lite 90P ...:
Product Chemistry: Product Identity and
Composition. Unpublished study prepared by Nissan
Chemical Industries, Ltd. 32 p.
40933107 Mandaya, N.; Todhunter, J. (1988) Hi-Lite 90G ...:
Product Chemistry: Product Identity and
Composition. Unpublished study prepared by Nissan
Chemical Industries, Ltd. 32 p.
40933112 Mandava, N.; Todhunter, J. (1988) Hi-Lite 60G ...:
Product Chemistry: Physical and Chemical
Characteristics and Other Requirements.
Unpublished study prepared by Nissan Chemical
Industries Ltd. 27 p. \
40933115 Mandava, N.; Todhunter, J. (1988) Nissan D.C.C.Na.
Granular ...: Product Chemistry: Physical and
Chemical characteristics and Other Requirements.
Unpublished study prepared by Nissan Chemical
Industries, Ltd. 27 p.
40933116 Mandava, N.; Todhunter, J. (1988) Nissan T.C.C.A.
Granular ...: Product Chemistry: Product Identity
and Composition. Unpublished study prepared by
Nissan Chemical Industries, Ltd. 32 p.
10
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APPENDIX C
Chlorinated Isocyanurates Bibliography
Citation
40992403 Richter, J. (1989) [Product Chemistry]: '' <
Trichloro-s-triazinetrione Tablets: Laboratory '.-';,;
Project: 1988-12. Unpublished study prepared by,1'
Fertilizers & Chemicals Ltd. 25 p. • • v -
41010602 Three-V Chemical Corp. (1989) Product Specific Data: "-
Analysis and Certification of Product Ingredients?
Oxidan TCA. Unpublished compilation. 11 p,
41010702 Three-V Chemical Corp. (1989) Oxidan: Analysis and
Certification of Product Ingredients. Unpublished
study. 10 p. ;
41044301 Quintini, M. (1989) Trichloro-s-triazinetrione: Product
Specific Data: Laboratory Project ID: API 101-88.
Unpublished study prepared by Apital Produzioni
Industrial! S.p.A. 4 p. /
41044401 Quintini, M. (1989) sodium Dichloro-s-triazinetrione: ; ,
Product Specific Data: API 102=88. Unpublished
study prepared by Apital Produzibni Industrial!
S.p.A. 3 p.
41044402 Quintini, M. (1988) Sodium Dichloro-s-triazinetrione:
Product Chemistry: Laboratory Project ID API
102-88. Unpublished study prepared by Apital
Produzioni Industrial! S.p.A. 3 p.
41044501 Quintini, M. (1989) sodium Dichloro-s-triazinetrione
Dihydrate: Product Specific Data: Laboratory
Project ID API 103-88. Unpublished study prepared
by Apital Produzioni Industrial! S.p.A. 3 p.
41044502 Quintini, M. (1988) Sodium Dichloro-s-triazinetrione
Dihydrate: Generic Data: Product Chemistry:
Laboratory Project ID API 103-88. Unpublished
study prepared by Apital Produzioni Industrial!
S.p.A. 3 p.
11
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APPENDIX C
Chlorinated isocyanurates Bibliography
MRID Citation
41054103 Mandava, N.; Todhunter, J. (1989) Nissan D.C.C.Na.
Dihydrate Granular: Product Chemistry: Physical
and chemical Characteristics and Other
Requirements. Unpublished study prepared by
Nissan Chemical Industries, Ltd. 130 p.
41072201 Doshida, A. (1987) Sodium dichloroisocyanurate
dihydrate—Product Chemistry (Sodium
dichloro-s-triazinetrione dihydrate): Product
Identity and Composition: Project ID: Nisso/Chiba
No. 011/87. Unpublished study prepared by Nippon
Soda Co. , Ltd. .22 p.
41072203 Doshida, A. (1987) Sodium dichloroisocyanurate
Dihydrate—Product Chemistry (Sodium.
Dichloro-s-triazinetrione Dihydrate): Physical and
Chemical Characteristics: Project ID: Nisso/Chiba
No. 013/87. Unpublished study prepared by Nippon
Soda Co., Ltd. 93 p.
41119301 Shikoku Chemicals Corp. (1989) Analysis and
Certification of Product Ingredients: Neo-Chlor
90: Shikoku-1989-3. Unpublished study prepared by
Shikoku Chemicals Corp. 11 p.
41513601 Skirkanich, N. (1990) Product Chemistry: Thrifty
Granular, Thrifty Black Algaecide, Thrifty Sticks,
Thrifty 1" Tablets and Thrifty 3" Tablets.
Unpublished study prepared by Olin Corp. Research
canter. 26 p.
12
-------
APPENDIX D
List of Available Related Documents
-------
-------
Th« following is a list of available documents related to
the chlorinated isocyanurates. Its purpose is to provide a path
to more detailed information if it is needed. These accompanying
documents are part of the Administrative Record for the
chlorinated isocyanurates and are included in the EPA's Office of
Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Chlorinated Isocyanurate RED Fact Sheet
4. PR Notice 91-2 (included in this RED) pertains to the
Label Ingredient Statement
Federal publications on the chlorinated isocyanurates are
available and may be purchased from the National Technical
Information Service (NTIS) 5285 Port Royal Road, Springfield, VA
22161. (Phone #: (703) 487-4650.
. 1. Guidance for the Reregistration of Pesticide Products
Containing Chlorinated Isocyanurates as the Active
Ingredient (The 1988 Registration Standard):
NTIS Stock No. PB88-220660.
2. "Compendium of Acceptable Uses" (The use index for" the
1988 Registration Standard) NTIS'Stock No. PB89-122147.
-------
-------
UNfTtD STAT18 ENV1RONMIMTAL
WASHNOTOM, O.C.
PA MOT1C1 91-2
*« stews *«aroac
NOTICE TO MANUFACTURERS, PRODUCERS,
AMD REGISTRANTS OF PESTICIDES
ATTEKTIOM: R.giatration of
I. PURPOSE:
.i2E5H«*<«> ' «• «»*« t.rm i,
th« Agency has
aec«ptabl«
product.
II • BACKGROUND
.
!? S? noainal concentration •• th* only 4cc.pt ab la
or th« uount of aetiv* i«grodi«nt in th« product!
U»t«d in th«
l« r«fl«cting
40 CF* 13«.10(9)(3). Th« certified
n™,. *. ctiv« i«9r«di««t ar« int«nd«d to
153^73* wjT * manufacturing practice variations 40 CFR
Pnntta of s~ctt rt f
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2.
The upper and lower certified liaits, which must be proposed in
connection with a product's registration, represent the amounts of
an ingredient that may legally be present 40 CFR 153.175. The lower
certified liait is used as the enforceable lover limit for the
product coaposition according to FIFRA section 12(a)(l)(C), while
the noainal concentration appearing on the label would be the
routinely achieved concentration used for calculation of dosages
and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual product
composition because; the noainal concentration would be the amount
of active ingredient typically found in the product.
It is important for registrants to not* that certified liaits
for active ingredients are not considered to be trade secret
information under FIFRA section 10(b). In this respect the
certified liait* will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing on
th« label may not represent the enforceable coaposition for
purpose* of section 12(a)(l)(C).
ZZZ. RZQCXMHBITS
As described below under Unit V. • CQNfUAJiCl SOaOOll," all
currently registered products as well as all applications for new
registration must: comply with this Notice by specifying the nominal
concentration expressed as a percentage by weight as the label
claim in the ingredient(s) statement and equivalence statements if
applicable (e.g., elemental arsenic, metallic sine, salt of an
acid). In addition, the requirement for performing sample analyses
of five or more representative samples must be fulfilled. Copies of
the raw analytical data must be submitted with the noainal
ingredient label claim. Further information about the analysis
requirement say ba found in the 40 cm 131.170. All products are
required to provide certified liaits for each active, inert
ingredient, imparities of toxicological •ignificancaU.e., upper
liait(a) only) and on a case by casa basis as specified by EPA.
Tbasa limits* are to ba set baaed oa representative sampling and
chemical analysis(i.a., quality control) of the product.
Tho format of the ingredient statement oust conform to 40 CFR
ISC-Labaling Requirements For Pesticides and Devices.
After July 1. 1»»T, all peaticids> ingredient statements aust
ba changed to noainal concentration.
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tV. PROOCCTS THAT RfQOIM ITflCXCt DATA
AH paaticidas ar« i?«quir«d to be afficacioua. Tharafora
the eartifiad lovar liaits may not be iowar than tha minimum
lavai to acaiava •Cficacy. This is axtraaaly important Cor
products which ara intandad to control pasts which threaten tha
pualic haalth, a.g., cartain antimicrobial and rodantieida
products. Rafar to 40 cm isa.so.
In thosa casas whara «fficacy liaits hava baan «stablishad,
tha Aqancy will not sceapt careifiad lovar liaits which ara balow
laval for tha shalf lifa o« tha product.
". COMPLXANCZ SCHZOCLE
As dascribad aarliar, tha purposa of this Hotica is to aaka
tha raqistration procass aora uniform and aora aanaqiabla Cor
both tha agancy and tha raqulatad covaunity. it is tha Agancy's
intantion to iaplaaant tha raquiraaants of this notica as
saoothly as possibla so as not to disrupt or dalay tha Aqancy's
high priority programs, i.a., raragistration, naw chaaical, or
fast track (7IFKA saction 3(c)(3)(8). Thar a fora,
applicants/ragistrants ara axpactad to comply with th«
raquiramants of this Notica as Collovst
(1) Baginnirxj July i, 19«1, all nav
ragistrations aufeaittad to tha
ar« to comply with th« raqulraa^nta of this
Mocica.
(2) Roqistrants having products aubjace to
raraqistration undar rXTKA section 4 (a) arm to
comply with th« rmqair«m«nt« of this Hotica whan
•pacific products ar« callad in by th« Mancy
undor Phas« v of th« Raraqistration trepan.
(3) All othsr products/ applications) that arm
nee subjace to (1) and (2) above will hava until
July l, 19»7, to comply with this Monica.
Such applications) should notsj •Conversion
to Vominal Concantration* on the application
font. These types of- amendments will no« be
handled as "Fast Track* applications but
will be handled as routine requests.
ZVfOWUTZOM
Contsce Tyrone) Aiken for information or qoestions concaming
this nOtiCS) Ott (703) 537-5024.
>
^- '
Anne) t. Lindsay, Oirestor
Registration Division (H-7305
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APPENDIX E
Pesticide Reregistration Handbook
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Unftad States Office of Octobar 1991
Environmental Protection Pesticide Programs
Agency _,
v>EPA Pesticide
Reregistration
Handbook
How to Respond to
the Reregistration
Eligibility Document
(RED)
Printed c"
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PESTICIDE REREGISTRATION HANDBOOK
HOW TO RESPOND TO THE
REREGISTRATION ELIGIBILITY DOCUMENT (RED)
OFFICE OF PESTICIDE PROGRAMS
ENVIRONMENTAL PROTECTION AGENCY
OCTOBER 1991
Printed on
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PRODUCT REREGISTRATION HANDBOOK
TABLE OF CONTENTS
I. Introduction
A. Purpose and Content 1
B. Reregistration Eligibility Document 1
C. Reregistration Process 1
II. Instructions for Responding
A. How and When to Respond 2
B. When No Response Is Needed "5
B. Where to Respond 6
III. Submission of Data and Labels/Labeling
A. Generic Data 6
B. Product Specific Data 7
1. Product Chemistry 7
2. Acute Toxicity 8
3. Product Performance 9
C. Labels/Labeling 10
Appendix
A. Confidential. Statement of Formula and Instructions
B. Label Contents
C. Sample Label Formats—General Use & Restricted Use
D. Label Regulations (40 CFR 156.10)
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PESTICIDE REREQISTRATION HANDBOOK
I. INTRODUCTION
A. Purpose and Content of this Handbook
This Handbook provides instructions to registrants on how to
respond to the Reregistration Eligibility Document (hereafter
referred to as the "RED") and how to reregister products.
Section I is this introduction.
Section II contains step-by-step instructions which must be
followed by registrants responding to the RED.
Section III provides additional instructions on the format,
content and other aspects of generic data, product specific data
and labels/labeling which may be required to be submitted.
Detailed instructions are in the Appendix.
B- The Rereaistration Eligibility Document fREDl
Under Section 4 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), as amended in 1988, EPA is required to
reregister pesticides that were first registered before November 1,
1984. The RED describes in detail the subject chemical, its uses
and its regulatory history; describes EPA's decision concerning the
eligibility of the uses of the chemical for reregistration; and
explains the scientific and regulatory bases for this decision.
EPA's reviews1 of the data by scientific discipline are available
upon request. Appendices to the RED contain: (1) a Data Dall-In
Notice which requires submission of generic and product specific
data and which gives directions for responding, (2) a listing of
existing studies that satisfy generic data requirements and (3) a
bibliography of the generic studies EPA has reviewed.
C. The Rerecriatration Process
Reregistration involves a thorough review of the scientific
data base underlying a pesticide's registration. The purpose of
EPA's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide, to determine whether
the data base is substantially complete or there is need for
additional generic data, and to determine whether the pesticide is
eligible for reregistration. This decision is issued as the RED.
EPA's science reviews and information on the registered
uses considered for EPA's analyses may be obtained from: EPA,
Freedom of Information, 401 M St., S.W., Washington, D.C. 20460.
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If the RED declares that some or all uses of the chemical are
eligible for reregistration, affected registrants must first
respond within 90 days of receipt to the data call-in portion of
the RED. Within 8 months of receiving the RED, registrants must
submit or cite any data and labels/labeling . required for each
product. EPA has until 14 months after the RED is issued (i.e.,
6 months after the registrants' 8 month deadline) to review the
submission for each product and decide whether. to reregister it
based on the following criteria:
—whether all of the product specific data and labels/labeling
are acceptable,
—whether all of the uses on the label/labeling are eligible,
—whether all of the active ingredients in the product are
eligible, and
—if no List 1 toxic inert ingredient is contained in the
product (a List 1 inert is permitted only if all data
for it have been submitted and EPA determines
that the inert does not pose any unreasonable adverse
effects in that product). ,
Products which meet all of these criteria will be
reregistered. Products which do not meet,all of these criteria,
but which have acceptable product specific data and labeling, will
be processed as amendments in order to implement label changes
required by th« RED..
II. INSTRUCTIONS FOR RESPONDING
A. How and When to Respond
This section provides directions for submitting timely and
adequate responses necessary to reregister products containing the
active ingredient covered by the RED. Registrants must follow
these steps exactly to avoid suspension of their products. All
products containing the active ingredient in the RED (i.e.,
manufacturing use products/ end use products and special local need
(SLH or Section 24o) registrations] are subject to the requirements
of the RED. figure 1 summarizes how and when to respond to the
RED. A step-by-step explanation follows.
Step 1. Ara Expedited Label Changes Required?. In some
instances, EPA may conclude that certain changes to product
labels/labeling must be implemented rapidly. If the RED requires
expedited label/labeling changes, registrants must submit the items
below by the deadline specified in the RED. If expedited label
changes are not required, go to Step 2.
a. Application for Registration (EPA Form 8570-1) . Complete
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and sign the form. in Section II, insert the phrase "Expedited
Amendment in Response to the Reregistration Eligibility Document
for (insert ease name for chemical)." Applications for expedited
label changes will be processed as applications for amended
registration. Use only an original application form with a red
identifier number in the upper right-hand corner.
b. Five (5) copies of revised draft label and labeling.
Refer to the RED for label/labeling changes and follow the
instructions in Section III.C. and the Appendix of this Handbook
for revising the label and labeling for each product.
Step 2. Are data required? If the RED requires generic or
product specific data, you must follow the directions in the data
call-in notice in the RED. All registrants must respond for all
products within 90 days of receipt? products for which an adequate
response is not received on time will be subject to suspension. No
tjme extensions will be given for responding within 90 dava.
3- Are Uses of a Pesticide Eligible for Rereaistratign?
If any uses of the active ingredient (s) covered by the RED are
eligible for reregistration, follow these instructions. If no. uses
are eligible, no. further response may be needed (see page 5).
EPA's decision on the eligibility of each of the uses of the
active ingredient (s) is presented in the RED. If anv uses of a
chemical are eligible for reregistration, registrants for
manufacturing-use products (MPs), end-use products (EPS) and
special local needs registrations (SLNs), must submit the items
below for each product within 8 months of the date of issuance of
the RED:
a. Application for Reregistration (use EPA Form 8570-1).
Complete and sign the form. In Section II of that form, check the
box "Other" and insert the phrase "Application for Reregistration."
Use only an original application form with a red identifier number
in the upper right-hand corner.
(S) copies of revised draft label and labeling.
Refer to the RED for labeling changes specific to the active
ingredient, follow the instructions in Section III.C. of this
Handbook and refer to the Appendix of this Handbook for guidance on
current requirements for labels and labeling. If there are
ineligible uses on the label or labeling, you may delete such uses
and avoid all requirements and consequences which may be associated
with ineligible uses (e.g, generic data requirements, cancellation,
suspension, etc.). If you delete certain uses now and those uses
become eligible for reregistration later, you must submit an
amendment application to add those uses back to the label.
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FIOURB 1. HOW AND WHEN TO RESPOND TO THE IREREGISTRATION
ELIGIBILITY DOCUMENT (RED) POR MANUFACTURING USB
PRODUCTS (MPS)/ END-USE PRODUCTS (EPS) and SPECIAL
LOCAL NEEDS REGISTRATIONS (SLNs).
STEP l: Are expedited label revisions required?
Yes
Submit application
and labels on
expedited schedule
specified in RED.
STEP 2: Are data required?
Yes
Submit forms within
90 days for generic
and product specific
data.
No
No
STEP 3:
•^•^^
Are any of the uses on the label
eligible for reregistration?
Yes
Are any uses on the label
ineligible for reregistration?
Yes
Do you wish to
delete ineligible
uses from label?
.Yes
No
For each HP & EP
& SLH (240) submit
application within
8 month*. If
the submission
is acceptable,
the label will be
stamped accepted
as an amendment.
No reregistration
will be issued.
for each HP t EP
6 SLN (24o) submit
application within
8 months. If
the submission
is acceptable,
the label will be
stamped accepted
and a notice of
reregistration
will be issued.
No further response
necessaxy. Await
the outcome of
EPA's review.
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c. Product specific Data. You must follow the instructions
in the Data Call-in Notice in the RED and in Section ill of this
Handbook. Responses to the data call in are due within 90 days of
receipt of the RED and submission or citation of data is due within
8 months of the issuance of the RED.
d. Two (2) copies of the current Confidential.statement of
Formula (EPA Form 8570-4, revised February 85). Two completed and
signed CSF forma must be submitted for the basic formulation and
for each alternate formulation, if CSFS are not provided for the'
alternate formulas, they will not be reregistered and will no
longer be acceptable. The Appendix of this Handbook has specific
instructions for completing the CSF form.
e. Certification With Respect to Citation of Data (EPA Form
8570-31). This form must be completed, signed and submitted for
each product to assure that the data compensation provisions of
FIFRA are met.
B. When No Response is Needed
If no uses of a pesticide are eligible for reregistration, it
is unlikely that you will be required to submit product specific
data or labeling. Uses of an active ingredient may be declared
ineligible for reregistration for two possible reasons:
—Available data indicate that one or more of the criteria for
an in-depth special review have been metj
—Additional generic data are required.
In the first instance, if the active ingredient is placed into
special review, reregistration activities associated with those
uses of the chemical are stopped until EPA makes a final
determination. At that time, EPA will indicate which uses may be
eligible for reregistration and which uses are to be cancelled. If
some or all of the previously ineligible uses become eligible for
reregistration, EPA will start the reregistration process for
products containing only eligible uses.
In the second instance, based upon the review of studies for
an active ingredient during reregistration, additional generic data
(e.g., second- or third-tier studies) may be needed (see the RED).
In such cases, the chemical's uses will not be eligible for
reregistration until the additional generic data have been
submitted to and reviewed and found acceptable by EPA. If the data
are reviewed and found to be acceptable, EPA will indicate which
uses will be eligible for reregistration and will initiate
reregistration of products containing previously ineligible uses.
If the data are not submitted, products containing the active
ingredient may be suspended.
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C. Where to Respond
By U.S. Mail:
Document Processing Desk (insert distribution coda)
Office of Pesticide Programs (H7504C)
Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001
By express mail or by hand delivery:
t
Document Processing Desk (insert distribution code)
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
These mailing .addresses and the following distribution codes
must be used to assure the timely receipt and processing of your
submissions. Not using them may significantly delay the handling
of your submissions:
RED-SRRD-Jope (where xxx is the case code given on the front of
the RED)—use this distribution code for all responses pertaining
to or containing generic data. Such responses include the 90-day
response forms for generic data or hard copies of generic data.
RED-RD-PMxx (where xx is the Product Manager team number)—
use this distribution code for all responses pertaining to or
containing product specific data or labeling. Such responses would
include expedited labeling amendments, 90-day responses to product
specific data requirements, hard copies of product specific data
and applications for reregistration.
III. SUBMISSION OF DATA AND LABELS/LABELING
This section provides additional instructions concerning
responses required for generic data, product specific data and
labels/labeling.
A. Generic Data
During EPA's evaluation of an active ingredient for
reregistration, additional generic data requirements may be
identified that registrants must fulfill. In some instances these
data requirements would have to be satisfied before an active
ingredient or some of its uses could be declared eligible for
reregistration. In other cases, these new data requirements would
not affect the eligibility of the active ingredient, but would be
necessary to confirm EPA's assessment of that chemical.
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Any new data requirements and how they affect reregistration
eligibility of a chemical are discussed in the RED. If new generic
data requirements are imposed in a Data Dall-ln Notice in the RED,
registrants must respond as described in that Notice. The RED also
contains instructions for completing these forms, a citation of
EPA's legal authority for requiring the new data, a listing of
options available to registrants for satisfying the data
requirements and the name of the contact person for inquiries.
B. Product Specific
Product specific data may be required for the reregistration
of each pesticide product in three areas—product chemistry, acute
toxicity and efficacy.
1- Product Chemistry
Following are instructions for submitting product-specific
data and a discussion of EPA's policy on inert ingredients.
a. Data
All data requirements for MPs, EPs and SLNs (24c's) are
specified in the Data Call-in Notice in the RED. In addition:
— If you cite data from another identical, registered
product, you must identify the EPA registration number of that
product .
--If the product-specific data submitted or cited do not
pertain to an identical formulation to the product submitted for
reregistration., then new product-specific data are required to be
submitted by the deadline specified in the Data Call-in Notice.
The only exception is for products which EPA "groups" together a
being similar enough to depend on the same data. Such groupings
are discussed in the appendix to the RED (for acute toxicity
purposes, for example), if it was feasible to do so.
b. Inert Ingredient?
EPA has implemented a strategy for regulating inert
ingredients which affects the reregistration of pesticide products.
This strategy, issued on April 22, 1987 (52 FR 13305-13309) and
updated on November 22, 1989 (54 FR 48314-48316), adopted certain
policies designed to reduce the potential for adverse effects from
pesticide products containing intentionally added inert
ingredients. EPA divided the known inert ingredients into four
categories:
— Inerts of toxicological concern (List 1) for which available
data demonstrate toxic effects of concern (includes about 50
chemicals) .
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—Potentially toxic inerts (List 2) for which only limited
data are available, but such data or the chemical structure suggest
the potential for toxicity (includes about 60 chemicals).
—Inerts of unknown toxicity (List ;3) for which no data or
bases for suspecting toxic effects are available (includes up to
2,000 chemicals).
--Inerts of minimal concern (List 4) which are generally
regarded as innocuous (includes about 290 chemicals).
When a RED is issued and any uses of an active ingredient are
declared eligible for reregistration, all products containing that
active ingredient .will be subject to reregistration. EPA will, as
part of the reregistration review, examine the inert ingredients of
each product prior to reregistration to ensure that they do not
present unreasonable risks. In reviewing the product chemistry
data, EPA will identify List 1 inerts. EPA will continue to
encourage registrants to eliminate any List 1 inerts present.
Reregistration of products containing only List 2, 3 or 4 inerts
will be unaffected by the inerts strategy.
Consistent with the strategy on inerts, a product containing
a List 1 inert ingredient will not be reregistered until a full
risk assessment of the product has been conducted, based on the
data called in for that inert ingredient. However, the existing
registration of a product containing a List 1 inert will remain
valid as long as the product bears the required label warning and
is in compliance with any outstanding DC1, or other activity under
the inerts strategy.
Any product containing a List 2, 3 or 4 inert max b«
reregistered if it meets all other requirements for reregistration.
As the inerts strategy is implemented and data for the List 2 and
3 inerts are reviewed, EPA may move these inerts to the other
Lists. If an inert were moved to List l, products containing that
inert would become ineligible for reregistration. Inert
ingredients must also meet normal registration and tolerance
requirements, as applicable.
2. Acute Toxicitv
The data call-in notice in the RED specifies the acute
toxicity data required for reregistration of each MP or EP. It
indicates whether any of the standard tests have been waived and,
if so, why.
If feasible, EPA will "batch" products that are similar with
respect to their acute toxicity so that one set of tests can
support reregistration of each baatch of products. This approach
will impose the least amount of testing - necessary to adequately
support the registration and labeling for pesticide products. T*e
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main benefits of this approach are to minimize the need for animal
testing, reduce the expense to registrants to generate the tests
and decrease the resources EPA must spend on reviewing data.
Registrants may contact other registrants with products in the same
"batch" to decide whether to provide or depend on one set of data;
alternatively, registrants may choose to conduct their own studies.
3. Product Performance
Consult the Data Call-in section of the RED to determine
whether Product Performance data are required.for your product.
Product performance (efficacy) data are generated in studies
designed to document how candidate pesticide formulations perform
as pest control agents. These data include tests run to determine
whether a formulation is lethal to certain pest species, to
document the effectiveness of the formulation in controlling pest
species in actual use situations, and to determine whether certain
claims beyond mere control of a pest (e.g., "six-month residual
effect," "kills Warfarin resistant house mice," -etc.) are
justified.
EPA has standard protocols for certain efficacy tests. In
general, standard methods have been developed for tests needed to
substantiate claims that have been made frequently for pesticide
products. As the scope of potential pesticidal claims is extremely
broad, the Agency does not have standard methods for tests needed
to substantiate many pesticide claims, especially those that are
uncommon. The Product Performance Guidelines, Subdivision G, offer
general guidance for developing protocols for efficacy testing.
Proposed protocols should be submitted to EPA for review before
tests are initiated.
a. Efficacy Data Submission Waiver Policy
FIFRA gives the Administrator of EPA authority "to waive data
requirements pertaining to efficacy" but does not require that
efficacy data requirements be waived for any class of pesticide
product registered under Section 3 of the Act. As a matter of
policy, EPA does not require submission of efficacy data to support
many types of pesticidal claims but does require submission of such
data for certain types of claims. As noted in 40 CFR 158.640, this
waiver applies to the submission of efficacy data rather than to
the generation of efficacy data. EPA expects each registrant to
"ensure through testing that his products are efficacious when used
in accordance with commonly accepted pest control practices."
This general policy notwithstanding, EPA may, at any time,
require a registrant to submit efficacy data to support any claim
made for a product. EPA also may require that certain claims of
effectiveness be established before a Section 3 registration is
granted.
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10
b. Claims and Products for Which Efficacy Data Generally
Are Required
Submission of efficacy data at reregistration typically is
required for the following types of products:
1. products claimed to control microorganisms that
pose potential threats to public health;
2. products claimed to control vertebrate pests that
may directly or indirectly transmit diseases to
humans;
3. potentially very hazardous products for which EPA
determines that it is necessary to conduct a "risk-
benefits" analysis;
4. products of types for which EPA has reasons (e.g.,
consumer complaints, unlikely claims, unusual use
patterns, etc.) to question claims; and
C. Labels and Labeling
To remain in compliance with FIFRA, the label and labeling of
each product must be revised to meet the requirements for
reregistration as described below. "Labeling" includes the
container label and-any written, printed or graphic matter that
accompanies the pesticide in U.S. commerce at any time (such as
technical bulletins, collateral labeling, etc.). Applications for
new uses or labeling changes that do not pertain to reregistration
must be filed separately from the application for reregistration
described in Step 3 earlier. Changes to labeling which must be
made for reregistration include, but are not limited to:
i
1. Labeling changes specified in the RED. Such changes may
include statements, on RESTRICTED USE, groundwater hazards,
protective clothing/equipment, endangered species, environmental
hazards, etc.
2. The format and content of labeling as described in 40 CFR
156.10. When further acute testing is needed, the currently
accepted precautionary statements will usually be retained until
testing is completed and the data are reviewed.
3. Labeling changes required by Pesticide Regulatory (PR)
Notices, regulations, regulatory decisions and policies issued by
EPA which are relevant to the pesticide. Your product's labeling
must reflect any applicable requirements which are in effect at the
time the RED is issued. Some existing notices are referred to in
Section B. of the Appendix.
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APPENDIX
A. Confidential Statement of Formula and Instructions
B. Instructions for Label Contents
C. Sample Label Formats—General Use & Restricted Use
D. Label Regulations- (40 CFR 156.10)
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instruction? for Completing tha Confidential Statement of
The Confidential Statement of Formula (CSF)' Form 8570-4 must
be used. Two legible, signed copies of the form are required.
Following are basic instructions:
a. All the blocks on the form must be filled in and answered
completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of
the responsible party must be provided.
d. All applicable information which is on the product-
specific data submission must also be reported on .the CSF.
e. All weights reported under item 7 must be in pounds per
gallon for liquids and pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame
extension in inches.
g. For all active ingredients, the EPA Registration Numbers
for the currently registered source products must be reported under
column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all
actives and inerts and all common names for the trade names must be
reported.
i. For the active ingredients, the percent purity of the
source products must be reported under column ; 10 and must be
exactly the same as on the source product's label.
in
1. All the weights in columns 13. a. and 13. b. must be
nounds, kilograms, or grams. In no case will volumes be accepted.
D^not Sx English1 .aid metric system units (i.e.,. pounds and
kilograms) .
Jc. All the; items under column 13. b. must total 100 percent.
1. All item* under columns 14^a. and 14. b. for the active
ingredients must represent pure active form.
m. The upper and lower certified limits for all active and
inert ingredients must follow the 40 CFR 158.175 Jjfajf^fJJ- ejj
explanation must b« provided if the proposed limits are different
than standard certified limits.
n. When new CSFs are submitted and approved, all previous. /
submitted CSFs become- obsolete for that specific formulation.
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B. INSTRUCTIONS FOR TABEL CONTENTS
40 CFR 156.10 and Pesticide Regulatory (P.R.) Notices require
fJSf, TH. tngi statements appear at certain locations on
aDeJ. . Tne a«mn I a 1 a Vial ^^.»-.4._ i_» a-._^_«
Item 1. PRODUCT NAME - The name, brand or trademark is required to
*® 3OCat*? °n th,G fr°nt pane1' Preferably centered .in the upper
pa • £ ^he Pane;!-' The name °f a product will not be accepted if
it is false or misleading. [40 CFR I56.10(b)]
Item 2. COMPANY NAME AND ADDRESS - The name and address of the
producer, registrant or person for whom the product is produced are
required on the label and should be located at the bottom of the
front panel or at the end of the label text. [40 CFR I56.10(c)]
Item 3. NET CONTENTS - A net contents statement is required on all
labels or on the container of the pesticide. The. preferred
location is the bottom of the front panel immediately above the
company name and address, or at the end of the label text. The net
contents must be expressed in the largest suitable unit, e.g. "i
pound 10 ounces" rather than "26 ounces." in addition to English
'?« fA,I\ contents may be expressed in metric units. [40 CFR
156 . 10 (d) ]
Item 4 . EPA REGISTRATION NUMBER - The registration number assigned
to the pesticide product must appear on the label, preceded by the
phrase "EPA Registration No.," or "EPA Reg. No." The registration
number must be set in type of a size and style similar to other
-P*art of *he label on wnich it appears and must run
* ^f re9istration number and the required
phrase must not appear in such a manner as to suggest
» the
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number
£S?S! tJ y ^* £hrase "EPA Est-" i« the final establishment at
which the product was produced, and may appear in any suitable
location on the label or immediate container. It must also appear
°n* J?fi ^raPPer or outside container of the package if the EPA
establishment number on the immediate container cannot De clearly
read through such wrapper or container. [40 CFR I56.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
^^l7/^1^ °n tha front pane1' The ingredients statement
must contain the name and percentage by weight of each active
ingredient and the total percentage by weight .of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. it
must not be placed in the body of other text. [40 CFR 156. 10 (g) ]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural
-------
formulations, the pounds per gallon of active ingredient must be
indicated on the label. [40 CFR 156.10(h)(iv)]
Item 6C. NAMES TO BE USED IN INGREDIENT STATEMENT - The acceptable
common name, if there is one, shall be used, followed by the
chemical name. If no common name has been established, the
chemical name alone shall be used. Chemicals related to the active
ingredient are allowed to be listed only if efficacy data
supporting such claims are submitted or referenced. If such data
are provided, the related chemicals must be listed separately and
not as a portion of the active ingredient.
Item 6D. INERT INGREDIENTS RECLASSIFIED AS ACTIVE INGREDIENTS - If
EPA has reclassified chemicals from inert ingredient status to
active ingredient status, registrants of affected products must
change the ingredient statement accordingly (See 52 FR 13307-8,
April 22, 1987). If such pesticides have food uses, tolerances
must either be established for such uses, or an exemption from the
requirement for tolerances must be obtained.
Item 6E. NOMINAL CONCENTRATION - The amount of active ingredient
declared in the ingredient statement must be the nominal
concentration of the product as defined in 40 CFR 158.153(i) and
described in P.R. Notice 91-2.
Item 7. WARNINGS AND PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label on
Front Panel
in square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word
Minimum Type Size
All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement "Keep Out
of Reach of Children" must be located on the front panel above the
signal word except where contact with children during distribution
or use is unlikely. [40 CFR I56.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the child
hazard warning statement. [40 CFR 156.10(10(1) (i) ]•
-------
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the label in
red on a background of distinctly contrasting color and the skull
and crossbones shall appear in immediate proximity to the word
POISON. [40 CFR 156.10(h)(1)(i)].
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the label
of pesticide products in toxicity Categories I, II, and III. [40
CFR 156.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "see Side (or Back)
Panel for Additional Precautionary Statements" is required on the
front panel for all products, unless all required precautionary
statements appear on the front panel. [40 CFR I56.l0(h)(1)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary
statements listed below must appear together on the label under the
heading "PRECAUTIONARY STATEMENTS." The preferred location is at
the top of the side or back panel preceding the directions for use,
and it is preferred that these statements be surrounded by a block
outline. Each of the three hazard warning statements must be
headed by the appropriate hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a hazard
exists to humans or domestic animals, precautionary statements are
required indicating the particular hazard, the route(s) of exposure
and the precautions to be taken to avoid accident, injury or
damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to non-
target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential accident,
injury, or damage. [40 CFR 156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY Precautionary
statements relating to flammability of a product are required to
appear on the label if it meets the criteria in the PHYS/CHEM
Labeling Appendix. The requirement is based on the results of the
flashpoint determinations and flame extension tests required to be
submitted for all products. These statements are to be located in
the side/back panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that no signal word
is used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3 (d) requires
that all pesticide formulations/uses be classified for either
general or restricted use. Products classified for restricted use
may be limited to use by certified applicators or persons under
their direct supervision (or may be subject to other restrictions
that may be imposed by regulation) . If your product has been
classified for restricted use, then these requirements apply:
-------
1. All~u»e« restricted. The following statements must be placed
in a black box at the top of the front panel of the label and
labeling:
a. The statement "Restricted Use Pesticide" must appear at
the top of the.front panel of the label. The statement
must be set in type of the same minimum size as required
for human hazard signal word [see table in 40 CFR
156.10(h)(1)(iv) ]. No statements of any kind may appear
above this RUP statement.
b. The reason.for the the restricted use classification must
appear below the RUP statement. The RED will prescribe
this statement.
c. A summary statement of the terms of restriction must
appear directly below this reason statement on the front
panel. If use is restricted to' certified applicators,
the following statement is required: "For retail sale to
and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered
by the Certified Applicator's Certification." The RED
will specify what statement must be used.
2. Some but not all uses restricted. If the RED states that some
uses are classified for restricted use, and some are
unclassified, several courses of action are available:
a. You may label the product for Restricted use. If you do
so, you may include on the label uses that are
unrestricted, but you may not distinguish them on the
label as being unrestricted.
b. You may delete all restricted uses from your label and
submit draft labeling bearing only unrestricted uses.
c. You may "split" your registration, i.e., register two
separata products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
label*. Both applications should be submitted
simultaneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the misuse
statement, "It is a violation of Federal law to use this product in
a manner inconsistent with its labeling." This statement appears
at the beginning of the directions for use, directly beneath the
heading of that section.
Item 10A. REENTRY STATEMENT - If a restricted entry interval (RED
has been established by the Agency, it must be included on tr.e
label. Additional worker protection statements may be required .n
-------
accordance'with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are required to
bear storage and disposal statements. These statements are
developed for specific containers, sizes, and chemical content.
These instructions must be grouped and appear under the heading
"Storage and Disposal" in the directions for use. This heading
must be set in the same type sizes as required for the child hazard
warning. Refer to P.R. Notices 83-3 and 84-1 to determine the
storage and disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be stated
in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment. [40 CFR 156.10(i)(2)]
COLLATERAL LABELING .
Bulletins, leaflets, circulars, brochures, data sheets, flyers, or
other written or graphic printed matter which is referred to on the
label or which is to accompany the product are termed collateral
labeling. Such labeling may not bear claims or representations
that differ in substance from those accepted in connection with
registration of the product. Collateral labeling must be made part
of the response to the RED and submitted for review.
-------
-------
LABEL FORMAT FOR UNCLASSIFIED PRODUCTS
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-------
LABEL FORMAT FOR PRODUCTS CLASSIFIED FOR RESTRICTED L'CE
i
orfii.
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-------
Environmental ProtectIon Agency
submitter has asserted a confidential
business information claim concerning
the material).
(5) A copy of each document, propos-
^ Or other item of written material
concerning the Registration Standard
provided by the Agency to any person
or party outside of government
(within 15 working days after the item
is made available to such person or
party).
(6) A copy of the Registration Stand-
ard:
(7) With respect to a Registration
Standard for which the Agency has
determined that a substantially com-
plete chronic health and teratology
data base exists, a copy of the FEDERAL
REGISTER notice concerning availabil-
ity of a proposed Registration Stand-
ard, and a copy of each comment re-
ceived in response to that notice
(within 10 working days after receipt
by the Agency, or 15 working days if
the submitter has asserted a confiden-
tial business information claim con-
cerning the material).
(8) A copy of the FEDERAL REGISTER
notice announcing the issuance of the
Registration Standard (within 10
working days after the publication of
the notice).
(c) Index of the docket. The Agency
will establish and keep current an
index to the docket for each Registra-
tion Standard. The index will include,
but is not limited to:
(1) A list of each meeting between
the Agency and any person or party
outside of government, containing the
date and subject of the meeting, the
names of participants and the name of
the person requesting the meeting.
(2) A list of each document in the
docket by title, source or recipients),
and the date the document was re-
ceived or provided by the Agency.
(d) Availability of docket and indi-
ces. (1) The Agency will make avail-
able to the public for inspection and
copying the docket and index for any
Registration Standard,
(2) The Agency will establish and
maintain a mailing list of persons who
have specifically requested that they
receive Indices for Registration Stand-
ard dockets. On a quarterly basis, EPA
will distribute the indices of new mate-
rials placed in the public docket to
§ 154.10
these persons. Annually, E ""A will re-
quire that persons on the list renew
their requests for inclusion on the list.
(3) The Agency will issue annually in
the FEDERAL REGISTER (in conjunction
with the annual schedule notice speci-
fied in S 155.25) a notice announcing
the availability of docket indices.
(4) Each FEDERAL REGISTER notice of
availability of a Registration Standard
will announce the availability of the
docket index for that Standard.
§ 155.34 Notice of availability.
(a) The Agency will issue in the FED-
ERAL REGISTER a notice announcing the
issuance and availability of Registra-
tion Standard which:
(1) Concerns a previously unregis-
tered active ingredient; or
(2) Concerns a previously registered
active ingredient, and the Registration
Standard states that registrants will
be required (under FIFRA section
3(c)(2)(B)) to submit chronic health
(including, but not limited to, chronic
feeding, oncogenicity and reproduc-
tion) or teratology studies.
(b) Interested persons ma"y submit
comments concerning any Registra-
tion Standard described by paragraph
(a) of this section at any time.
(c) The Agency will issue in the FED-
ERAL REGISTER a notice announcing the
availability of, and providing opportu-
nity for comment on, each proposed
Registration Standard which concerns
a previously registered active ingredi-
ent for which the Agency has deter-
mined that a substantially complete
chronic health and teratology data
base exists. Following the comment
period and issuance of the Registra-
tion Standard, the Agency will issue in
the FEDERAL REGISTER a notice of avail-
ability of the Registration Standard.
PART 156»LABEUNO REQUIRE-
MENTS FOR PESTICIDES AND DE-
VICES
AUTHORITY: 7 U.S.C. l36-136y.
§ 154.10 Labeling requirements.
(a) General—(1) Content* of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
75
-------
§156.10
lations in this Part. The contents of a
label must show clearly and promi-
nently" the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(iii) The net contents as prescribed
in paragraph (d) of this section;
Civ) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An Ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(vlil) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classiflcation(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousnes* (a» compared with
other word*, statements, designs, or
graphic matter on the labeling) and
expressed in such terms-as to render it
likely to be read and understood by
the ordinary individual under custom*
-ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B> Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to 6« used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
40 CFR Ch. I (7-1-89 Edition)
other-language versions of the label.
ing.
(4) Placement of Label—
-------
Environmental Protection Agoncy
(U, A false or misleading statement
concerning, the effectiveness of the
product as a pesticide or device;
(j]D A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) Ii the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, i.e., "1 pound 10 ounces" rather
than "26 ounces."
(S) In addition to the required uniti
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum is not permit-
ted. In no case shall the average con-
77
-------
§156.10
tent of the packages In a shipment fall
&. _«.^ +VA *+*t«/4 *v*»rAJ?C contfCilw.
DC10W vne sv»tca * v* *•*-• ntirn&tfr.
(e) Product registration num^e^
The registration number "f1*^ of
the P^tlcldewprodu^ .t the
K i w "
preceded by the P«g" "^-PA Reg.
^£ It Th£ Registration number
the required Identifying phrase
not SSear in such a manner as
ouggest or imply recommendation
o? endorsement of the product by the
(fT Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number • on the immediate
container cannot be clearly read
through such wrapper or container.
Cg> Ingredient statement—U) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active Ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement
(i) The ingredient statement is nor-
mally required on the front panel of
40 CFt Ch. I (7-1-89 Edition)
tn« label. If there Is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it Impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(11) The text of the Ingredient state-
ment must run parallel with other
text on the panel on which It appears,
and must be clearly distinguishable
from and must not be placed In the
body of other text.
(3) Names to be used in ingredient
statement The name used for each in-
gredient shall be the accepted
common name, if there is one, fol-
lowed by the chemical name. The
common name may be used alone only
if it Is well known. If no common name .
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of section 25(c)(6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
78
-------
|j|VJronm«nt«l Prot««t!«n Agency
/n In cases where it la determined
h»t a pesticide -formulation changes
h«mical composition significantly,
fhe product must bear the following
tatement in a prominent position on
"
Not
or use
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredients ) to be listed in the
ingredient statement If he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warning and precautionary
statements. Required warnings and
precautionary statements concerning
§ 154.10
the general areas of toxicologies!
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxlcity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
rtazvti indicators
Oral LDt*
inhalation LC«.
Eye affects
Stan effect*. .
Toncrty catagone*
I
Up to and including SO
mg/kg.
Up to and mcKong .2
mg/uter.
Up to and including 200
mg/kg.
Corrowve: eomeal
opacity not reversbf*
witnn 7 day*.
Corrouve
II [ HI | IV
From 50 mru 500 mg/kg..
From .2 mru 2 mg/Mer
From 200 mru 2000
day*; rritaoon .
peraietlng for 7 day*.
Saver* irritation at 72
hour*.
From 500 thru 5000 mg/
kg.
From 2. mnj 20 mg/liter...
From 2.000 thru 20,000....
No eomeal opacity:
irritation raver**!*
wrtUMii 7 day*.
Mooerate irritation at 72
nour*.
Greater man
Greater man
Greater man
72 hour*.
5000 mg/
20 mg/liter.
20,000.
mtafloo at
(i) Human hazard signal word—
-------
§156.10
it is approved for use on infanta
or small children, may the Administra-
tor waive this requirement.
(Ill) Statement of practical treat-
ment- e^a^a^aA a^^*a^aa*a^k««A f^ •weut^b^ad
irrDim pvnvi Mswnivre ov prvcacew
gum*].
U^_. t^gt fe^had kt g^^^^a^B.^^ut PUiJkA^aMA
MMy OV IW H WBWWJ linna»J»JO
trough «e aUnJ. Oo not breath* vapor* Cduat or
•pray nMl. Do not gat in eyea, on akin, or on
doting. CApproprlaliiftratiid rtaiarnenta reoured.].
IV.
akin]. Avoid bfaatHnq vapor* Cduat or apray miatl
Avoid contact wNh Hdn Ceyee or donng]. CAppro-
priaM fttt aid atatamant raqured.].
No precautionary ataMrnants raojund.] ..........................
Corroeive. eauaaa ay* and akin damage Cor dun
irritation]. Do not gat in eyea. on skin, or on
dotting. Wear goggle* or lace anMd and rubber
gtovaa wnan nandfcig. HamvM or fatal if *nr*Ho««d.
CAppropnata
proprtala flrat akt statement ieojuired*j
Avoid contact w*tt eWn, aye* or dotting. In C«M o<
contact immediately flueh aye* or aWn witt plenty at
Get medical attention H irritation penata.
iment* required.]
CNopi
80
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j^o
Pro««««on Agency
environmental hazards. Where a
(U * exists to non target organisms
__ humans and domestic ani-
'^ecautionary statements are re-
stating the nature of the
and the appropriate precau-
to avoid potential accident,
f iury or d*131**6- Examples of the
risard statements and the circum-
tances under which they are required
(A) If * pesticide intended for out-
door use contains an active ingredient
Irith a mammalian acute oral LDH of
Too or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC» of 1 ppm or less,
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LDM of 100
or less, or a subacute dietary
LC.. of 500 ppm or less, tht statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(iii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Fla*n point
Requred text
(A) PMf SSURIZEO COMTAINCRS
Flasn pom at or below 20* F: if mere » a flashback at
any valve openng.
Flash pant above 20* F and not over 80* F or H the
flam* extension is more than 18 in long at a distance
of 6 in from the flam*.
Al other pressurized container! —
Extremely flammable. Content* under pressure. Keep away from
fire, spark*, and,heated surfaces. Do not puncture or incinerate
container. Exposure to" temperature* tbove 130* F may cause
bursting.
Flammable. Contents under presaur*. Keep away from heat
spark*, and open flame. Do not puncture or inenerate container.
Exposure to temperature* tbove 130* F may caua* burnng.
Contents under pressure. Oe not UM or store near heat or open
dame. Do not puncture or incnerat* comamar. Exposure to
temperature* above, 130* F may cause bursting.
(B) NONtWfUUMIZCD CONTAIN***}
At or bdow 20* F
Above 20* F and not over 80* F..
Above W F and not over 1 SO*
Extremely flammable. Keep away from fire, spark*, and heated
surface*.
Flammatt*). Keep away from heat and open Itena.
Do not UM or store near heat or open flame.
(i) Direction* for tfie- General
requirements—
-------
§156.10
(B) The .label bears a reference to
the directions for use In accompanying
leaflet* or circulars, such as "See di-
rections in the enclosed circular:" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(iil) Exceptions to requirement for
direction for use— The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale Is limited
to physicians, veterinarians, or drug-
gists, provided that:
U) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3> The product I* also a drug and
regulated under the provisions of the
Federal Food, Drue and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators In preparing
pesticides for sale to the public, pro-
vided that:
U) There is information readily
available to the formulators on the
composition, toxicity, methods of use.
applicable restrictions or limitations.
40 CFR PU I (7.1-89 Edition)
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product Is intended for use only in
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
(3) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use";
(i) The statement of use classifica-
tion as prescribed in paragraph (j) of
this section immediately under the
heading "Directions for Use."
(ii) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(ill) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application. In-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vli) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum size*
as required for the child hazard warn-
ing. (See Table in i 162.10(h)(l)(lv»
82
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j
Protection Agoney
limitations or restrictions on
c* required to prevent unreasonable
iSerse effects, such as:
(A) Required intervals between ap-
lication and harvest of food or feed
cr(°B> Rotational crop restrictions.
,£) Warnings as required against use
certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
(E) P°r restricted use pesticides, a
statement that the pesticide may be
aoptied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
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APPENDIX F
Generic Data Call-In
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Jj WASHINGTON, D.C. 20460
MAY 7 1993
DATA CALL-IN NOTICE
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain data as noted herein to the U.S.
Environmental Protection Agency (EPA, the Agency). These data
are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days
after you receive this Notice you must respond as set forth in
Section III below. Your response must state:
l. how you will comply with the requirements set forth in
this Notice and its Attachments A through F; or
2. why you believe you are exempt from the requirements
listed in this Notice and in Attachment C, Requirementa
Status and Registrant's Response Form, (see section
III-B); or
3. why you believe EPA should not require your submission
of data in the manner specified by this Notice (see
section III-D).
If you do not respond to this Notice, or if you do not
satisfy EPA that you will comply with its requirements or should
be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension.
We have provided a list of all of your products subject to this
Notice in Attachment B, Data Call-In Response Form, as well as a
list of all registrants who were sent this Notice (Attachment D).
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 (expiration date 12-31-92) .
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This Notice i3 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 II - Data Required By This Notice
Section III - 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: :
Attachment A - Data Call-In Chemical Status Sheet
Attachment B - Data Call-In Response Form
Attachment C - Requirements Status And Registrant's Response
Form
Attachment D - List Of All Registrants Sent This Data
Call-In Notice
Attachment E - EPA Acceptance Criteria
Attachment F -' Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for; this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. This reevaluation
identified additional•data necessary to assess the health and
safety of the continued use of products containing this active
ingredient. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA KBOVIRBP
i
The data required by this Notice are specified in
Attachment C, Requirements Status and Registrant's Response Form.
Depending on the results of the studies required in this Notice,
additional testing may be required.
1I-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the
data requirements specified in Attachment C, Requirements Status
and Registrant's Response Form, within the timeframes provided.
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II-C. TESTING
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.
Thes.e EPA Guidelines are available from the National Technical
Information Service (NTIS) , Attn: Order Desk, 5285 Port Royal Road
Springfield, Va 221S1 (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 § 158.70). When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements
of 40 CFR § 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N W
Washington, D.C. 20006. * "
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) ].
I3:-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3 (eU21 fBl NOTICES
ISSUED BY THE AGENCY •• »-••«*•«. «»vi i«u-v»f «v«*vw
Unless otherwise noted herein, thia Data oii-Tg dpea_..not in
any way supersede or change the requirement « of anv previous Data
Call - In (S) , or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent
to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTIC^
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
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.
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III-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 III-C. A discussion of options
relating to requests for data waivers is contained in Section III-
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
Zojon, Attachment B and the Requirements Status and Registrant's
Response Form. Attachment C. 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 A.
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
provision* of this Notice which are contained in Section IV-C.
2. Use Deletion - You may avoid the requirements of this
Notice by eliminating the uses of your product to which the
requirements apply. If you wish to amend your registration to
delete uses, you must submit the Requirements Status and
Registrftyfe'* 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
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Response F9CT. You must also complete a Ba£aCall-ln
by signing the certification, iteS number 8
om^
.557?2126 S^aency Response Branch, Registration Division, (703)
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 pata Exemption - Under section 3(c)(2)(D) of
FIFRA, an applicant for registration of a product is exempt from
the requirement to submit or cite generic data concerning an active
ingredient if the active ingredient in the product isderived
exclusively from purchased, registered pesticide products
containing the active ingredient. EPA has concluded, as an
exercise of its discretion, that it normally will not suspend the
ji0n.£f a Pro?ucS which would qualify and continue to
J°r the9eneri<= ^ta exemption in section 3(c) (2) (D) of
TO qualify, all of the following requirements must be met:
a. The active ingredient in your registered product must be
present solely because of incorporation of another
registered product which contains the subject active
ingredient and is purchased from a source not connected
With you; ""<=<- weu
b. Every registrant who is the ultimate source of the active
ingredient in your product subject to this DCI must be in
compliance with the requirements of this Notice and must
remain in compliance; and
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. Attachment B and all
supporting documentation. The Generic Data Exemption ia item •
number 6a on the Data Call-in Reanonss Pn™. If you claim a
generic data exemption you are not required to complete the
RsgAlirementa Status and Registrant' a Response Por^. Generic Data
Exemption cannot be selected as an option for product specific
CL2LC3L •
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
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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 Q^ ^ia Notice There are
various options available to satisfy the data requirements of this
Notice. These options are discussed in Section III-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 Pfltft
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 Real at rant ' a 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.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NQTICB
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 Recriptr?nt ' a Response ! Form related to data
production for each data requirement. Your option selection should
be entered under item number 9, "Registrant Response." The six
options related to data production are the first six options
discussed under item 9 in the instructions for completing the
Requirements Status and Registrant's Response Form These six
options are listed immediately below with information in
parentheses to guide registrants to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified
timefram* (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 BPA 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)
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Potion 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. In addition,
certain studies require Agency approval of test protocols in
advance of study initiation. Those studies for which a protocol
must be submitted have been identified in the Requirements Status
and Registrant's Response Form and/or footnotes to the form. If
you wish to use a protocol which differs from the options discussed
in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing to
use it. The Agency may'choose to reject a protocol not specified
in Section II-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of
a proposed protocol will not be a basis for extending the deadline
for submission of data.
A progress report must be submitted for each study within 90
.days from the date you are required to commit to generate or
undertake some other means to address that study requirement, such
as making an offer to cost share or agreeing to share in the cost
of developing that study. 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 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-JSegistrant's
Response Form are the time frames that the Agency is allowing for
the submission of completed study reports or protocols. The noted
deadlines run from the date of the receipt of this Notice by the
registrant. If the data are not submitted by the deadline, each
registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
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
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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 £0-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 Coat 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 Coat of Data Development -- If
you have made an offer to pay in an attempt to enter into an
agreement or amend an existing agreement to meet the requirements
of this Notice and have been unsuccessful, you may request EPA (by
selecting this option) to exercise its discretion not to suspend
your registration(s), although you 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 BPA Form
8570-32, Certification of Offer to Cost Share in the Development of
Data, Attachment E. In addition, you must demonstrate that the
other registrant to whom the offer was made has not accepted your
offer to enter into a costsharing agreement by including a copy of
your offer and proof of the other registrant's receipt of that
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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
b
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of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by
signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data1
may include photographs, microfilm or microfiche copies,
computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments.11
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 EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the
manner in which all Agency comments, concerns, or issues were
addressed in the final protocol and study, i
If you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
10
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contain factual information regarding unreasonable adverse effects
you must notify the Agency of such a study. If such stSSy 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 A. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA
Your submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a
study classified as .unacceptable and determined by the Agency as
not capable of being upgraded.
This option 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 beincr
upgraded. * 3
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 stTidi«ff -- 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
11
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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.
III-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
ingredients whose total production volume for all pesticide
registrants is small. In determining.whether to grant a low
volume, minor use waiver the Agency will consider the extent,
pattern and volume of use, the economic incentive to conduct the
testing, the importance of the pesticide, and the exposure and risk
from use of the pesticide. If an active ingredient is used for
both high volume and low volume uses, a low volume exemption will
not be approved. If all uses of an active ingredient are low
volume and the combined volumes for all uses are also low, then an
exemption may be granted, depending on review of other information
outlined below. An exemption will not be granted if any registrant
of the active ingredient elects to conduct the testing. Any
registrant receivincr 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, aa a condition of the
waiver, to submit annual sales reports. The Agency will respond to
requests for waiver* in writing.
To apply for a low volume, minor use waiver, you must submit
the following information, as applicable to your product(s), as
part of your 90-day response to this Notice:
a. (i). Total company sales (pounds and dollars) of all
registered product(s) containing the active ingredient.
If applicable to the active ingredient, include foreign
sales for those products that are not registered in this
country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above
information by year for each of the past five years.
12
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(ii). Provide an estimate of the sales (pounds and
dollars) Of the active ingredient for each major use
site. Present the above information by year for each of
the past five years.
b. Total direct production cost of product(s) containing the
active ingredient by year for the past five years.
Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other
significant costs listed separately.
c. Total indirect production cost (e.g. plant overhead,
amortized plant and equipment) charged to product(s)
containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were
directly related to the active ingredient, such as costs
of initial registration and any data development.
d. (i). 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
onducting the testing needed to fulfill each of
these data requirements.
(ii). 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
associate'd test) of conducting the testing needed to
fulfill each of these data requirements.
e. For each of the next ten years, a year-by-year fore- cast
of company sales (pounds and dollars) of the active
ingredient, direct production costs of product(s)
containing the active ingredient (following the
parameters in item 2 above), indirect production costs of
product(s) containing the active ingredient (following
the parameters in item 3 above), and costs of data
development pertaining to the active ingredient.
f. A description of the importance and unique benefits of
the active ingredient to users. Discuss the use patterns
and the effectiveness of the active ingredient relative
to registered alternative chemicals and non-chemical
control strategies. Focus on benefits unique to the
active ingredient, providing information that is as
quantitative as possible. If you do not have
quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To
assist the Agency in determining the degree of importance
of the active ingredient in terms of its benefits, you
should provide information on any of the following
13
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factors, as applicable to your product (s): (a)
documentation of the usefulness of the active ingredient
in Integrated Pest Management, (b) description of the
beneficial impacts on the environment of use of the
active ingredient, as opposed to its registered
alternatives, (c) information on the breakdown of the
active ingredient after use and on its persistence in the
environment, and (d) description of its usefulness
against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to
make a determination regarding a request for a low volume/minor use
waiver will result in denial of the request for a waiver.
2. Request for- Waiver of Data -- Option 9 on the Reguirementa
status and Registrant-- '« Regponae 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.
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 3(c) (2) (B) . Iff SPA determines that
the data ar^> -required for your product (s) .you must choose a mechoa
of meeting the reauirgmentg of fchia Noticft within the time. frame
r£*wTfted bv thin Notice. Within 30 days of your receipt of the
BSSffS Sri"" decision, you must submit a revised Requirements
fifcatua and Registrant •« Response Form indicating the option chosen.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS MQTICB
IV-A NOTICE OP TNTBNT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products
subject to thia 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
Swuuiee of a Notice of Intent to Suspend include, but are not
limited to, the following:
14
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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 III-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 Reaponae Form
and a Requirements Status and Registrant Va_jReapQn8^_JgLoJcnu
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.
15
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
PNACCBPTABLE
The Agency may determine that a study (even if submitted
within the required time) is unacceptable and constitutes a basis
for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of
the following:
1. EPA requirements specified in the Data Call-In Notice or
other documents incorporated by reference (including, as
applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of
required studies. Such requirements include, but are not
limited to, those relating to test material, test procedures,
selection of species, number of animals, sex and distribution
of animals, dose and effect levels to be tested or attained,
duration of test, and, as applicable, Good Laboratory
Practices.
2. EPA requirements regarding the submission of protocols,
including the incorporation of any changes required by the
Agency following review.
3. EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of
results, and the adequacy of any required supporting (or raw)
data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR 86-5. All
studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the
submission requirement.
i
IV-C EXISTING STOCKS OP 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
clearly demonstrating to EPA that granting such permission would be
consistent with the Act. You must also explain why an "existing
16
-------
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
listed in Attachment A, the Data Call-In Chemical Status Sheet.
17
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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 (Attachment B) and a
completed Requirements Status and Registrant's Response Form
(Attachment C) and any other documents required by this Notice, and
should be submitted to the contact person identified in Attachment
A. 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,
A
B
C
D
B
P
Daniel M. Barolo, Director
Special Review and |
Reregistration Division
Attachments
Data Call-in Chemical Status Sheet
Data Call-in Response Form
Requirements Status and Registrants
Response Form
List of Registrants Receiving This Notice
EPA Acceptance Criteria
Cost Share and Data Compensation Forms
18
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ATTACHMENT A
Chemical Status Sheet
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ATTACHMENT A
CHLORINATED ISOCYANURATES: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call -In Notice because
you have product (s) containing technical chlorinated isocyanurates
Generic Data Call-in Chemical Status Sheet, contains an
overview of the data required by this notice, and point of contact
for inquires pertaining to the reregistration of the chlorinated
isocyanurates. 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 B) , (3) The Requirements Status and
Registrant's Response form (Attachment C) , (4) a list of
registrants subject to this DCI and List of Products Subject to
this generic DCI (Attachment D) , (5) the EPA Acceptance Criteria
(Attachment E) , and (6) the Cost Share and Data Compensation Forms
in replying to this chlorinated isocyanurate Generic Data Call -In
(Attachment F) . Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the
generic database for the chlorinated isocyanurates are contained in
the Requirements Status and Registrant 'a Response Form. Attachment
C. The Agency has concluded that additional product chemistry data
on certain technical/manufacturing use products are needed. These
data are needed to fully complete the reregistration of all
eligible chlorinated isocyanurate 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 Karen Samek at (703) 308-8051.
All responses to this Notice for the generic data requirements
should be submitted to:
Document Processing Desk (RED-SRRD-0569)
Office of Pesticide Programs (H7504C)
Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001
RE: Chlorinated Isocyanurates
-------
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ATTACHMENT B
Generic Data Call-in Response Forms (Form A) Plus
Instructions
-------
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SPECIFIC INSTRUCTIONS FOR
THE DATA CALL-IN RESPONSE FORM
^no J0rm is designed to be used to respond to call-ins for
generic and product specific data for the purpose of rereqisteri
o5f ?hth%Federal HInsectici^ Fungicide and SxSnticl
1f°n ea you are responding to a data
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.
oot-^ reP°rtin9 ^rden for this collection of information is
estimated to average 15 minutes per response, including time for
fJX1™^11? ^ructions, searching existing data sources, gathering
S?iS£* tain^n? *he datFa 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, B.C. 20460; and to the Office
of Management and Budget, Paperwork Reduction Project 2070-0107
Washington, D.C. 20503. uxu/,
INSTRUCTIONS : ~ - ~ - ' -- - - —
Item 1. This item identifies your company name, number and
address .
Item 2. 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 EPA product registrations
relevant to the data call-in. Please note that you are
also responsible for informing the Agency of your
response regarding any product that you believe may be
covered by this data call-in but that is not listed by
the Agency in Item 4. You must bring any such apparent
omission to the Agency's attention within the period
required for submission of this response form.
Item 5. Check this item for each product registration you wish
to cancel voluntarily, if a registration number is
listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5. the date of
that request. You do not need to complete any item on
the Requirements Status and Registrant's Response Form
for any product that is voluntarily cancelled.
-------
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
Form that indicates how you will satisfy those
requirements .
Item 7a. Check this item if this call-in is 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 fho' 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 (EOT) as indicated in Item 3 and if your
product is a end use product for which you agree to
supply product- specific data. Attach the Requirements
Sfcatug and Registrant- '« Regnonge 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.
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.
-------
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ATTACHMENT C
Requirements Status and Registrants' Response Forms
(Form B) Plus Instructions
-------
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to
call-ins 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 data, instructions for completing the forms
differ slightly. Specifically, options for satisfying product
specific data requirements do not include (1) deletion of uses or
(2) request for a low volume/minor use waiver. 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 this 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 l. This item identifies your company name, number, and
address.
Item 2. 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.
Item 5. 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.
Item 6. This item identifies the code associated with the
use pattern of the pesticide. A brief description
of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
P Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I. Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 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
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
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
Typical End-Use Product
Typical End-Use Product, Percent Active
8Ingredient Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active
Ingredient and Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure
Active Ingredient
Technical Grade Active Ingredient or Pure
Active Ingredient Radiolabelled
Technical Grade Active Ingredient or
Typical End-Use Product
Metabolites
Impurities j
Degradates
See: guideline comment
Item 8. 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.
Item 9. 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) I will conduct a new study and submit
it within the time frames specified in item 8 above.
By indicating that I have chosen this option, I certify
that I will comply with all the requirements pertaining
to the conditions for submittal of this study as
outlined in the Data Call-In Notice and that I will
provide the protocols and progress reports required in
item 5 above.
2. (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.
3. (Offer to Cost Share) I have made an offer to enter
into an agreement with one or more registrants to
develop data jointly. I am submitting a copy of the
form "Certification of Offer to Cost Share in the
Development of Data" 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.
4. (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.
5. (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.
6. (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.
7. (Deleting Uses) I am attaching an application for
amendment to my registration deleting the uses for
which the data are required.
8. (Low Volume/Minor Use Waiver Request)' I have read the
statements concerning low volume-minor use data waivers
in the Data Call-In Notice and I request a low-volume
minor use waiver of the data requirement. I am
attaching a detailed justification to support this
waiver request including, among other things, all
information required to support the request. I
understand that, unless modified by the Agency in
-------
writing, the data requirement as stated in the Notice
governs. ;
|
9. (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 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. i
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.
-------
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ATTACHMENT D
List of Registrants Subject to this Data Call-In Notice
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-------
ATTACHMENT E
EPA Acceptance Criteria
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SUBDIVISION D
Guideline . Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and
trade name, if appropriate)
2. Name, nominal concentration, and certified limits (upper and
lower) for each active ingredient and each intentionally-
added inert ingredient
3. Name and upper certified limit for each impurity or each
group of impurities present at > 0.1% by weight and for
certain toxicologically significant impurities (e.g.,
dioxins, nitrosamines) present at <0.1%
4. Purpose of each active ingredient and each intentionally-
added inert
5. Chemical name from Chemical Abstracts index of Nomenclature
and Chemical Abstracts Service (CAS) Registry Number for each
active ingredient and, if available, for each .intentionally-
added inert
6. Molecular, structural, and empirical formulas, molecular
weight or weight range, and any company assigned experimental
or internal code numbers for each active ingredient
7. Description of each beginning material in the manufacturing
process
EPA Registration Number if registered; for other
beginning materials, the following:
Name and address of manufacturer or supplier
Brand name, trade name or commercial designation
Technical specifications or data sheets by which
manufacturer or supplier describes composition,
properties or toxicity
8. Description of manufacturing process
Statement of whether batch or continuous process
Relative amounts of beginning materials and order in
which they are added
Description of equipment
Description of physical conditions (temperature,
pressure, humidity) controlled in each step and the
parameters that are maintained
Statement of whether process involves intended chemical
reactions
-------
8. (continued)
9.
Plow chart with chemical equations jfor each intended
chemical reaction |
Duration of each step of process \
Description of purification procedures '
Description of measures taken to assure quality of final
product
Discussion of formation of impurities based on established
chemical theory.addressing (1) each impurity which may be
present at ^ O.i% or was found at > 0.1% by product analyses
and (2) certain toxicologically significant impurities
(see #3)
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61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered. Items 1, 2, 3, and 5 can be satisfied
for most registered products by submission of the Certified Statement
of Formula Ingredients Page (EPA Form 8570-4} . Items 7 and 8 can be
satisfied for most technical grade active ingredients (TGAIs) by.
submission of a flow chart with chemical equations for each intended
chemical reaction. The flow chart should include complete chemical
structures and names for each reactant and product of all the
reactions.
1. Name of technical material (include product name and trade name,
if appropriate).
2. Description of each active and intentionally-added inert
ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert •
ingredient.
5. Chemical name and' Registry Number for each active and
intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
and any experimental or internal code number for each active
ingredient.
7. Description of each beginning material in the manufacturing
process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
chemical theory.
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62 Analysis and Certification of Prodiict Ingredients
ACCEPTANCE CRITERIA :
The following criteria apply to the technical grade of the active
ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of
batch process) analyzed for each active ingredient and all
impurities present at .> 0.1%
2. Degree of accountability or closure .> !ca 98%
3. Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines both fresh and stored
samples must be analyzed.]
4. Complete and detailed description of each step in analytical
method used to analyze above samples
5. Statement of precision and accuracy of analytical method
used to analyze above samples
6. Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient
7. Upper and lower certified limits proposed for each active
ingredient and intentionally added .inert along with
explanation of how the limits were determined
8. Upper certified limit proposed for each impurity present at
£ 0.1% and for certain toxicologically significant
impurities at <0.1% along with explanation of how limit
determined
9. Analytical methods to verify certified limits of each
active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally
recognized as safe by FDA) are fully described
10. Analytical methods (as discussed in #9) to verify certified
limits validated as to their precision and accuracy
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62 Analysis and Certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Number of representative samples analyzed for all active
ingredients and all impurities at .> 0.1%.
2. Degree of accountability or closure in analyses in item #1.
3. Chemical names of toxic impurities which were analyzed for
levels <0.1%.
4. Brief description(s) of analytical method(s) used to measure
active ingredients and impurities in items #1 and #3.
S. Statement of precision and accuracy of method(s) in item #4.
6. Chemical name and quantities observed (range, mean, standard
deviation) for each ingredient (actives and impurities)
analyzed in item #1.
7. Proposed upper and lower certified limits for each active
ingredient and intentionally added inert with brief explanation
of how limits were determined.
8. Proposed upper certified limit for each impurity present at
>=0.1% and certain toxicologically significant impurities at
<0.1% with brief explanation of how limits were determined.
9. Brief description of analytical method(s) used to verify
certified limits (if same methods as item #4, may reference
latter).
10. Statement of precision and accuracy of method(s) in item #9
(may reference item #5 if applicable).
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63 Physical and Chemical Characteristics .
ACCEPTANCE CRITERIA
The following criteria apply to the technical:grade of the active
ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of
Munsell color system :
63-3 Physical State '
Verbal description of physical state provided using terms
such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor •
Verbal description of odor (or lack of it) using terms
such as "garlic-like, characteristic of aromatic
compounds" :
Observed at room temperature
63-5 Melting Point
Reported in C° :
Any observed decomposition reported
63-6 Boiling Point
Reported in C°
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in
g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of
registered products may be reported in Ibs/ft or
Iba/gallon.]
-------
63-8 Solubility
Determined in distilled water and representative polar and
non-polar solvents, including those used in formulations
and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if
sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from
measurements made at higher temperature if pressure too
low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably
about 20 - 25° C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure
provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20 - 25° C
Measured following dilution or dispersion in distilled
water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
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63 Physical and Chemical Characteristics
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered. i
1. Description of color.
2. Description of physical state.
3. Description of odor.
4. Indication of melting point (in C°).
5. Indication of boiling point (in C°). :
6. Indication of density, bulk density, and specific gravity.
7. Indication of solubility. ;
8. Indication of vapor pressure.
9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH. !
12. Description of stability. !
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
81-7 Acute Neurotoxicity in the Hen
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81-1 Acute Oral Toxicity in the.Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 young adult rats/sex/group
3. Dosing, single oral may be administered; over 24 hrs.
4.* Vehicle control if other than water. :
5. Doses tested, sufficient to determine ajtoxicity category
or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all
test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals. !
Criteria marked with a * are supplemental and may not be required for
every study.
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8l-i Acute Oral Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g. solid, liquid, percent
AI in technical, end-use product, etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9. Significance of changes from the Acceptance Criteria
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA j
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 animals/sex/group
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-
450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours. '
6.* Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category
or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours
before dosing
g. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover
to retain test material and to prevent ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required for
every study.
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81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. The number of animals/sex/dose
3. Weight range of animals
4. Verification of single, dermal exposure
5. Duration of dermal exposure
6. Statement of vehicle control
7. Doses tested and results
8. Preparation of application site
9. Area of application site (percent body surface)
10. Occlusion of test material on application site
11. Individual observations on day of dosing and for at
least 14 days or until all animals appear normal (whichever is
longer).
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Product is a gas, a solid which may produce a significant
vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter
15 um or less).
3. At least 5 young adult rats/sex/group
4. Dosing, at least 4 hours by inhalation.
5. chamber air flow dynamic, at least 10 air changes/hour, at
least 19% oxygen content.
6. Chamber temperature, 22° C (±2), relative humidity 40-60%.
7. Monitor rate of air flow
8. Monitor actual concentrations of test material in breathing
zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category
or a limit dose (5 mg/L actual concentration of respirable
substance).
11. individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-3 Acute Inhalation Toxicity in the Rat
GUIDANCE FOR .SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. Statement of the inhalability of test substance
3. The number of animals/sex/dose
4. Duration of inhalation exposure
5. Number of chamber air changes/hour and the percent oxygen
content of chamber air
6. Ranges for chamber air temperature and relative humidity
7. Air flow rate
8. Analytical concentrations of test material in breathing zone
9. Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
11. Individual observations on day of dosing and for at least 14
days.
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <. 2 or >, 11.5.
3. 6 adult rabbits
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not; more than 100 mg if
a solid, paste or particulate substance!.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours. ;
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal or
21 days (whichever is shorter).
9.* individual daily observations. ;
Criteria marked with a * are supplemental and may not be required for
every study.
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81-4 Primary Eye Irritation in the Rabbit
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, cause severe dermal irritation
or has a pH of <2 or >11.5
3. Number of adult rabbits tested
4. State method of dosing, i.e., instillation into the conjunctival
sac of one eye per animal
5. Dose administered
6. Note whether solid or granular test material has been ground to
a fine dust
7. State whether eyes were washed and at what time post instillation
(not less than 24 hours)
8. State whether eyes were examined and graded for irritation before
dosing and at what periods after dosing
9. Individual daily observations afterwards, until eyes are normal
or for 21 days
10. Significance of changes from Acceptance Criteria
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive or has a
pH of <2 or > 11.5. !
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior
to dosing
7. Application site approximately 6 cm.
8. Application site covered with a gauze patch held in place
with nonirritating tape ;
9. Material removed, washed with water, without trauma to
application site I
10. Application site examined and graded for irritation at 1,
24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter). ;
11..* Individual daily observations. i
Criteria marked with a * are supplemental and may' not be required for
every study. ;
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81-5 Primary Dermal Irritation Study
GUIDANCE FOR SUMMARIZING STUDIES
1. The form^of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, has a pH <2 or >11.5, or has a
dermal LD 50 <200 mg/kg
3. Number of adult animals tested
4. Amount applied
5. Duration of dermal exposure
6. Preparation of application site (shaved or clipped at specified
time before dosing)
7. Area of application site
8. Method for occlusion of application site
9. Note removal of test material and if skin was washed with water
10. State times post application when site was graded for irritation
11. Individual observations for day of dosing and individual daily
observations thereafter
12. Significance of changes from Acceptance Criteria.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA .
dose your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3. One of the following methods is utilized;
Freund's complete adjuvant test ;
Guinea pig maximization test
Split adjuvant technique
Bushier test
Open epicutaneous test ;
Mauer optimization test
Footpad technique in guinea pig
4. Complete description of test
5,*, Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical .data
conducted within the last 6 months)
Criteria marked with a * are supplemental and may not be required for
every study.
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81-6 Dermal Sensitization in the Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. Complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria
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81-7 Acute Neurotoxicity in the Hen
ACCEPTANCE CRITERIA
|
Does your study meet the following acceptance criteria?
1. Study performed on an organophosphate cholinesterase
inhibiting compound.
2. Technical form of the active ingredient tested.
3.*, Positive control utilized.
4. Species utilized, domestic laying hen 8-14 months of age.
5. Dosing oral by gavage or capsule (dermal or inhalation
may be used).
6. An acute oral .LD is determined.
7. Dose tested equal to an acute oral LD or a limit test of
5000 mg/kg.
Dosed animals may be protected with atropine and/or 2-PAM.
Sufficient test animals so that at least 6 survive.
Negative (vehicle) control group of at least 6 hens
Positive control of at least 4 hens, (if used)
Test dose repeated if no signs of delayed neurotoxicity
observed by 21 days after dosing. :
Observation period 21 days after each dose.
Individual daily observations. :
Individual body weights.
Individual necropsy not required.
Histopathology performed on all animals. Tissue to be
fixed in sin preferably using whole animal perfusion
techniques. At least three sections of each of the
following tissues:
brain, including medulla oblongata
"spinal cord; upper cervical, mid-thoracic and
~lumbro-sacral regions
tibial nerve; proximal regions and branches
"sciatic nerve
Criteria marked with a * are supplemental and may not be required
for every study. <
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ATTACHMENT F
Cost Share and Data Compensation Forms
-------
-------
&EPA
Protection Agency
20460
United States Environmental
Washington, DC
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approred
OMB No. 2070-0107
2070-0057
Approval Expire* 3-31-t
Public reporting burden for this collection of information is estimated to averagTlS minutes per response Z^~"
tune for rev.ew.ng .nstructwns, searching existing data sources, gathering arx?maintaining thVdataWede^Tan?
^
PM 2% U?£^°ma^'^°Q ^stons for reducing this burden, to Chief, Information Policy
«fr,£Sl iii^f'ro'Ynental Protecton 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
Chemical Nam*
I Certify that:
Company Number
EPA Chemical Number
1.
3.
» ,,r, J? Support of reO'stralJon or ^registration under the Federal Insecticide, Fungicide and
Act (FIFRA) that is an exclusive use study. I am the original data submitter, or I have obtained the
wntten permission of the original data submitter to crte that study. cwumwuine
That for each study cited in support of registration or reregistratton under FIFRA that is NOT an exclusive use
study. I am the original data submitter, or I have obtained the written permission of the original data submitter or I
have notified in wnting the company(ies) that submitted data I have cited and have offered to- (a) Pay
compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
22J^!J!i?teTne W5? data are Subject to the "'"Pa"'"''™ requirement of FIFRA and the amount of
compensation due. rf any. The companies I have notified are: (check one)
I ] All companies on the data submitters' list for the active ingredient listed on this form (Cite-All
Method or Cite-All Option under the Selective Method). (Also sign the General Offer to Pav
below.) '
I ] The companies who have submitted me studies listed on the back of this former attached
sheets, or indicated on the attached -Requirements Status and Registrants' Response Form."
That I have previously complied with section 3(c)(i)(D) of FIFRA for the studies I have cited in support of
registration or reregistratton under FIFRA. «*• wn »•
Signature
Name and TUIe (Pleaae Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistratton of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D)
Date
Name and Title (Please Type or Print)
EPA Form *570-31 (4-90)
-------
r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
form Approve**
OUf Mo. 2070-0107
2070-0057
Approval EspU*« 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.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 Nam*
Chamlcal Nam*
1
Company Number
EPA Chemical Number
1 r>ftr*!f%» «hat«
My company Is willing to develp and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and RodentfckJe 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 developing
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) of FIFRA 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 Ftrm(a)
Oat* of Offer
Certification:
I certify that I am duty authorized to represent the company name 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's Authorized Reproaontatlv*
Nam* and Title (Pleaae Typo or Print)
Date
1PA Fom M7W2 (§-«1)
Replace* EPA Form a3»O-«, which la obaotat*
-------
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assigned to this product, if known.
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APPENDIX G
Product Specific Data Call-in
-------
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MAY 7 1993
DATA CALL-IN NOTICE OFFCEOF
PREVENTION, PESTCIDES
AND TOXC SUBSTANCES
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in Attachment
A of this Notice, the Data Call-in Chemical Status sheafrf to submit
certaxn 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 90 days after you
receive this Notice you must respond as set forth in Section III
below. Your response must state:
1. How you will comply with the requirements set forth in
this Notice and its Attachments A through G; or
2. Why you believe you are exempt from the requirements
listed in this Notice and in Attachment C,
Requirements Status and Registrant's Response^Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of
product specific data in the manner specified by this
Notice (see section Ill-D).
If you do not respond to this Notice, or if you do not satisfy
EPA that you will comply with its requirements or should be exempt
or excused from doing so, then the registration of your product(s)
subject to this Notice will be subject to suspension. We have
provided a list of all of your products subject to this Notice in
Attachment B, Data Call-In Response Form, as well as a list of all
registrants who were sent this Notice (Attachment F).
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 (expiration date 12-31-92).
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This Notice is divided into six sections and seven
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 II - Data Required By This Notice
Section III - 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: !
A - Data Call-In Chemical Status Sheet
B - Data Call-In Response Form
C - Requirements Status and Registrant's Response Form
D - EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Rereaistration
E - List of Registrantsfs^ sent this PCI
F - EPA Acceptance Criteria
G - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE .
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
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are
specified in Attachment C, 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 C, Requirements Status
and Registrant's Response Form, within the timeframes provided.
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II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal Road,
Springfield, Va 22161 (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 § 158.70). When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements
of 40 CFR § 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
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)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(e1L21CBI_NOTICBS
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data_C,a3JLr In does not in
anv wav supersede or change the requirements of anv previous_Jlata
Call-ln(s). or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent
to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICB.
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice
for product specific data must be submitted to the Agency within 90
days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a
basis for issuing a No.tice 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.
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III-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 choose the Voluntary
Cancellation option is presented below. A discussion of the
various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C. A
discussion of options relating to requests for data waivers is
contained in Section III-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
JEojau, and the Requirements Status and Registrant's Response Form.
Attachment B and Attachment C. The Data Callrin 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 B). 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 A.
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 choose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
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discussed in Section Ili-c of this Notice and
through 6 on the Requirement status
and 7b on the
equrement status *nH p^j,p
XLti™ nflbers 7a and 7b on the DJj^Call-ln R^ponJ ^SS5Sg-£
Deletion, of a use(s) and the low volume/minor use option are not
valid options for fulfilling product specific data requirement
Bequest for Product SpetH f Jc Data Waivera . Waivers for
Secific'data are discussed in Section lil-D S Sis Notice
C°Ver*d by °Pti°n 7 °n the R«Quir«m».nt.... Status *nH NOtlCS
> ^% Regponi5?* For™- If you choose this option/you must
iS ? ^ aS WSl1 aS any °ther informatioS/dat4 pertaining
the option chosen to address the data requirement. *"" fc*in:Ln3
I3:I-C SATISFYING THK DATA REQUIREMENTS OP THIS NOTT^B
a,,™1? voufcac|powjedge on the Data Call-in Reaprm«A Form that you
agree to satisfy the product specific data requirements (i e yoS
ontfSn^Sn1?? ?a °r-7b)' then y°U wamt ^lect one of the siS' Y
rS?i?oH ? Sh! ^eW^emg"tP Status -ami ReaifltMnt..a Regpnnga Form
fSSr?ftto data production for each data requirement. Your op?iSn
selection should be entered under item number 9, "Registrant
rstSOT data produci ar the
rn^L^ °ES °»S dfscussed un<*er item 9 in the instructions for
completing the Requirements Status and Registrant's Resmonsg For
t. immediately belo with
SSSSS5 ?J ^•9Uide fe9istrants ^ additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified
timeframe (Developing Data)
(2) I have entered into an agreement with one or more
/ox registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone (Submitting
an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and upgradeable
(Upgrading a Study)
(6) I am citing an existing study that EPA has classified as
acceptable or an existing study that has been submitted
but not reviewed by the Agency (Citing an Existing Study)
Option. 1, Developing Data -- If you choose to develop the
required data it must be in conf ormance 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
conf ormance with the requirements of PR Notice 86-5.
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The time frames in the Requirements Status and Registrant's
ResponseForm 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 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 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. Agree 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 registration number of the product for which data will be
submitted must be noted in the agreement to cost share by the
registrant selecting this option. 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 mist 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 Snare 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
pav 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 G. In addition, you must demonstrate that the other
registrant to whom .the offer was made has not accepted your offer
to enter into a costsharing 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
ESSB.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.
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.
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To meet the requirements of the DCI Notice for submitting an
existing Study, all of the following three criteria must be clearly
:
a. You must certify at the time that the existing study is
submitted that the raw data and specimens from the study are
available for audit and review and you must identify where they
are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP)
regulation, 40 CFR Part 160. As stated in 40 CFR,160.3(j)
" '[r]aw 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 data1 may include photographs,
microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recotded data from
automated instruments." The term-"specimens", according to 40
CPR 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 PIPRA 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
CPR 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.
8
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a^1,H5fm»^e,SU?^it an.existing study, you must certify that the
study meets all requirements of the criteria outlined above.
M«n °f 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
?£ Aa^,n?t1^ thS AgenCy °f SUCh a studv' 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 gfrudy -- 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 A. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA
Your submission must also specify the MRID number (s) of the study
SS S f.y°U of6 attemPtin9 to upgrade and must be in conformance with
JET iC fiOC x C€* 8 o ™ 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. y
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. J. a
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-
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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.
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
' s Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS '.
If you request a waiver for product specific data because you
believe it is inappropriate, you must attach a complete
justification for the request , including technical reasons , data
and references to relevant EPA regulations, guidelines or policies.
(Note: any supplemental data must be submitted in the format
required by PR Notice 86-5) . This will be the aaly. 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
Rfsgintr?"^'8 Response Form. Product specific data' requirements for
product chemistry, acute toxicity and efficacy (where appropriate)
are required for all products and the Agency will grant a waiver
only under extraordinary circumstances. You should also be aware
that submitting a waiver request will aat 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 OP PAILUBB TO COMPLY WITH THIS NOTICE
IV- A NOTTCS OP TMTBNT 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. i
10
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2. Failure to submit on the required schedule an acceptable
proposed or final protocol if 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 if 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* ,iFaflure to submit supportable certifications as to the
conditions of submitted studies, as required by Section III- c
of this Notice.
7. Withdrawal of an offer to share in the cost of developing
required data. * *» a
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 either to:
a. Inform EPA of intent to develop and submit the data
required by this Notice on a Data Call-XrLResponae Form and a
Requirements Status and Registrant's ReapQMg Form;
b. Fulfill the commitment to develop and submit the data as
required by this Notice; or
c. Otherwise take appropriate steps to meet the requirements
stated in this Notice, unless you commit to submit and do
submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of this
Notice.
IV-B- BASIS FOR DBTBRMTNATIQN THAT SUBMITTED STOPY Tfl
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:
11
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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 (if
applicable), including the incorporation of any changes
required by the Agency following review.
3. EPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted
in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
i
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
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 ylar 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
12 :
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distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular
risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day
response period required by this Notice will not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EPA will consider granting an existing stocks
provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that
if at_any time after a pesticide is registered a registrant has
additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency.
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 A, the Data Call-In ChemigaJLStatus Sheet.
All responses to this Notice (other than voluntary cancellation
requests) must include a completed Data Calljjn_Responae Form and a
completed Requirements Status and Registrant's ResponseForm
(Attachment B and Attachment C) and any other documents required by
this Notice, and should be submitted to the contact person(s)
identified in Attachment A. If the voluntary cancellation option is
chosen, only the Data Call-In Response Form need be submitted.
13
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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,
A
B
C
D
E
F
6
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
- Data Call-in Chemical Status Sheet
- Data Call -In Response Form
- Requirements Status and Registrant's Response Form
EPA Grouping of End-Use Products for Meeting Acute
Data Requirements for Rerediatration
of Registrants Sent This PCI
EPA Acceptance Criteria
Coat Share and Data Compensation Forms
14
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ATTACHMENT A
Chemical Status Sheet
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ATTACHMENT A
CHLORINATED ISOCYANURATES: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice
because you have product(s) containing the chlorinated
isocyanurates.
This Product Specific Data Call-In Chemical Status Sheet.
contains an overview of the data required by this notice, and point
of contact for inquires pertaining to the reregistration of the
chlorinated isocyanurates. 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 B) , (3)
The Requirements Status and Registrant's Response form (Attachment
C), (4) EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration (Attachment D); (5)
list of registrants receiving this DCI (Attachment E), (6) the EPA
Acceptance Criteria (Attachment F), and (7) the Cost Share and Data
Compensation Forms in replying to this chlorinated isocyanurate
Generic Data Call-in (Attachment G). Instructions and guidance
accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the
database for the chlorinated isocyanurates are contained in the
Requirements Status and Registrant's Response Form. Attachment C.
The Agency has concluded that additional product chemistry data and
toxicology data are needed for specific products. These data are
needed to fully complete the reregistration of all eligible
chlorinated isocyanurate products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the product specific data
requirements and procedures established by this Notice, please
contact Barbara Pringle at (703) 305-6484.
All responses to this Notice for the Product Specific data
requirements should be submitted to:
Document Processing Desk (RED/RD/PM32)
Office of Pesticide Programs (H7504C)
Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001
RE: Chlorinated Isocyanurates
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ATTACHMENT B
Product Specific Data Call-in Response Forms (Form A)
Plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING
THE DATA CALL-IN RESPONSE FORM
Product Specific Data
This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of reregistering
Acf 1CF??? ^r the Federal insecticide Fungicide and RodentfciS
call in iir-^iS- H^D^ SaCh time y°U are ^spending to a data
' '
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.
^•PU?1iCVrep0rtin9 burden for this collection of information is
estimated to average 15 minutes per response, including time for
fnrt1™^^18*^10*8' 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.
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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. 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).
Item 6. 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 (MP) or 7b (EP) on this
form, provide the EPA registration numbers of your
source(s) and complete and submit the "Generic Data
Exemption" form; you would not 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.
Item 7a. For each manufacturing use product (MP) 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 (EP) 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.
J£QT_S: 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 voluntarily cancelled this product. For these
cases, please supply all relevant details so that EPA can
ensure that its records are correct.
-------
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ATTACHMENT C
Requirements Status and Registrants' Response Forms
(Form B) Plus Instructions
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 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.
Item 4. 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 in
product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference
number is identified.
Item 6. 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.
Item 7. 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.
Item 8. The due date for submission of each study is identified.
It is normally based on 8 months after issuance of the
Reregiatration Eligibility Document unless EPA determines
that a longer time period is necessary.
Item 9. Enter only one of the following response code* 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.
1. 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.
2. 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 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
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Che required data; if the required study is not submitted
on time, my product may be subject to suspension.
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 III-C.I.) apply as well.
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
Notice (Section III-C.l.) 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 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 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 cite an existing study
that the Agency has 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 toxicity 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< If I
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cite another registrant's data, I will submit a completed
"Certification With Respect To Data Compensation
Requirements" form.
7. 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.
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 voluntarily cancelled this product. For these
cases, please supply all relevant details so that EPA can
ensure that its records are correct.
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ATTACHMENT D
EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
-------
-------
PRODUCTS FOR MEE™° ACUTE
?fit¥f
chlonnated .socyanurates, the Agency has batched products which can be considered sTmlr for
Kn^d'SrS"1^- FaCt°rS C°nSidered '" th6 S°rtin9 Pr°C6SS indude ^ch produc ' cTitand
inert ingredients ddent.ty, percent composition and biological activity), type of formulation (e a
emuls.f.ab e concentrate, aerosol, wettable powder, granular, etc.), and iabeHng (eg.,sS word use
a's'-s'Sn^r603?'0"^ 'abelin9' etC-K N°te that the A9enCV is not desc^"" batched products
or h'e idenS ^e patteTn" *"* Pr°dUCtS "**"
fro,, Batching HaS been accomP|ished usina the readily available information described above and
frequently acute toxicity data on individual end-use products has been found to be incomplete
Notwithstanding the batching process, the Agency reserves the right to require, at any time acute
toxicity data for an individual end-use product should the need arise.
°f ^'^ Pf°dUCtS within a batch mav choos8 to cooperatively generate, submit
a angle battery of s.x acute toxicological studies to represent all the products within that batch
It ,s the registrams' option to participate in the process with all other registrants, only some oHhe
other registrants, or only their own products within a batch, or to generate all he reauTed acut!
a°bSh 9h 3 ?UdieS f°r 6aCh °f the!r °Wn Pr0dUCtS' lf a reaistrant chooses fotneratTthe data for
ehnnl t , mUSt US8 °ne °f the Pr°dUCtS Within the batch as the te« material. If a reg'stran
chooses to rely upon prev.ously submitted acute toxicity data, he/she may do so provided that the
"
(S6e 3CCePtanC8 Cri«*a attached>' n
nti • V u be Sim"ar f°r acute toxicitv' and the formulation has not been
s.gmficant y altered smce submission and acceptance of the acute toxicity. data. Regardless of whether
~ ^ " referenC6d' n^m ™« dearly identify the test
In deciding how to meet the product specific data requirements, registrants must follow the
ronc ! fl'Ven '" the ?3ta Ca'Mn N°tice and its attachmems appended to the RED. T^e DC Not ce
contains two response forms which are to be completed and submitted to the Agency within 90 davs
r°flaru1™±tT5e fifSV°rm; "Dati,Cal|-|n ResP°ns«'- «ks whether the registramw^. meet the data
nTthl I / each Pf°duct- ^ second form- "Requirements Status and Registrant's Response -
A Batt«n°t h SP6
-------
purposes of acute toxicity or the Agency lacked sufficient information for decision making purposes.
Registrants of these products are responsible for meeting the acute toxicity data requirements for each
product. !
Table I.
B*tch
1
2
EPA Rog. No.
230-75
230-78
524-345
524-349
524-357
602-141
602- 182
602-293
1757-98
6284-49
7124-60
8791-53
8791-54
34S71-7
43680-9
45309-21
53254-4
230-72
524-353
624-359
524-36O
881-12
1072-17
1270-211
4313-48
4875-19
10428-18
% Dichloroitocyanuratas and any othar active
ingredients
40
40
40
40
40
65 '
65
65 I
45 i
55.6
57
40
40
54
54
57
40
•• .- ' :. ' " "
28
28
25
25
28
28
28 !
28 ;
28
28
Formulation Typa II
granular ||
granular ||
granular ||
granular
powder
powdar
powder ||
granular |j
granular
granular
granular
powdar
granular ||
powdar
powder
granular
powder
granular |
granular |
granular |
powder
powdar
granular
powder
powder
granular
. powder
-------
II Batch
3
4
EPA Reg. No.
•— — —
35495-11
40457-4
40871-6
48211-69
58880-1
230-76
524-361 '
524-362
524-363
1791-4O
4875-18
5768-12
5870-33
7546-17
8791-58
8791-59
10634*19
35495-12
37741-2
41831-6
49292- 1O
50600-4
62353-1
64864-6
524-371
524-372
524-373
875-89
875-94
875-98
% Dichloroisocyanurates and any other active
ingredients
28
23
28
28
28
25
25
25
25
25
25
25
25
30
25
25
25
25
25
25
25
25
25
26.5
34
34
34
25.8
13.8
6.9
'"•"^
Formulation Type
powder
powder
powder
-------
Batch
5
6
7
8
EPA Reg. No.
1677-141
1677-149
1706-142
4462-39
5736-17
7116-5
8540-14
9152-19
10508-6
10932-8
65020-3
5389-14
6198-5
6198-7
6198-13
524-364
524-365
524-366
524-367
8791-56
23O-74
524-368
§24-369
8791-55
1270-181
4313-49
6198-6
% Dichloroisocyanuratea and anv other activa ;
ingredients
22.25
28
18
20
17
6.8
25
16.5
'16 '
34
30 I
I
23.85 |
25
25
25 !
6 !
6
6
18
I
18
;'•••' -.-j^: • ' I
18
18
18
18
'••''.'. • ';"::.. "-:.v *:?'•' '•
5.6
- 5.6
5.6
"-'- v':. ,••:'•'•'••"-' •• ' ' '\
Formulation Type II
powder
granular
granular
powder ||
granular
granular
granular
granular
granular ||
powder ||
powder ||
granular |
powder
powder
tablet
granular
powder
granular
granular
powder
granular
powder
powder
granular
II
granular
granular
granular
-------
Batch
9
10
11
12
13
14
IS
:.-. *;.;:•:•'/;* ^v/;
16
EPA Rag. No.
1258-1160
1258-1161
1258-1165
1258-1166
1258-1159
1258-1162
1258-1163
1258-1164
3525-40
3525-53
3525-84
5185-311
9157-24
6284-30
7364-29
8791-5
8791-13
'.•'.;'- ' '' " '"' '". *'• " ' '" '•'.'• ' ':'"''
3522-18
6284-48
:;•:! ..:•::,;. . : •,••.;'••" •••:"'; .'•' '••• ''.'
5389-6
5768-14
3573-49
3573-51
•••-. -. '. .'.'.:•.: •'.••'•.'.'• •••'<::.•
1124-67
6466-12
% Dichloroisocyanurates and any othar active
ingrediants
50
50
50
50
25
25
25
25
57
57
57
64.6
60
49.1
49.1
47.5
49.1
86
87.7
?' ' - ;
6
6
" . ' ' ' ••"'.'•'
0.9
0.9
0.3
0.8
II
Formulation Typa
tablets
tablets
tablets
tablets
tablets
tablets
tablets
tablets
powder
powder
powder
granular
granular
granular
granular
granular
granular
;->:•;• ' . ,
tablet*
granular
-
granular ||
granular ||
'••'••''?:£'•" ' "•; ,•'•• II
powder |
J
powdar g
1
powdar |
powdar I
-------
Batch
17
18
19
20
21
22
23
24
EPA Rag. No.
3635-44
3640-61
65020-2
602-185
5389-10
1317-65
1677-91
833-44
48925-1
1677-53
7350-14
3635-101
3635-209
230-73
58262-1
4829-14
4329-19
4829-40
4829-50
4829-51
% Dichloroisocyanuratas and any othar active
ingredients
2.5
3.2
5.4
17.5
16.1
20.25
29
i
29
25
•
20.25 :
18
15
34
5.6
5.6
< ,• "•'
6O dichloroisocyanuraM
1 benzyl ammonium chloride
60 dichloroUocyanuraM
1 benzyl ammonium chloride
60 dichloroiiocyanurata •
1 benzyl ammonium chlorid*
64 dichloroiiocyanuraM
1 benzyl ammonium ohlorida
64 dichloroitocyanurata
1 benzyl ammonium chlorida '.
"••-•• -'. ' .,....,;.,,:.--.-.,.;. ...,,<......;;;. ..,;;.•...:.:;.•.
Formulation Type II
powder
powder
granular
powder
powder
granular
powder ||
powder I
powder ||
powder
powder
powder ||
granular
powder
powdar
tablet*
tablet*
tablet*
powdar
tablet*
.::••.••;.?'• A I
-------
Batch
25
EPA Rag. No.
524-377
524-395
524-404
5185-376
% Dichloroisocyanurates and any other activa
ingredients
96 dichloroisocyanurata
4 sodium bromida
39 dichloroisocyanurata
7 sodium bromida
89 dichloroisocyanurate
7 sodium bromida
81.S dichloroisocyanurata
1 4.6 sodium bromida
Formulation Type
granular
granular
granular
granular
Batch 26. The following batch consist of products {tablets, powder and granular formulations)
containing dichloroisocyanurates as the active ingredient in concentrations ranging from
98-100 % .
148-1167
230-50
230-57
230-60
230-63
230-69
275-78
278-50
523-313
524-105
524-108
524-325
524-335
524-338
524-379
524-381
524-383
524-385
524-388
524-389
1258-745
1258-852
1258-861
1258-886
1258-897
1258-898
1258-9O3
1258-9O7
1258-984
1258-1042
1258-1065
1258-1106
1258-1107
1258-1137
1258-1138
1258-1139
1258-1140
1258-1141
1258-1142
1258-1143
1258-1144
1258-1145
1258-1151
1258-1152
1258-1153
1258-1154
1258-1155
1258-1156
1258-1157
1258-1158
1258-1174
1317-80
1677-44
1729-93
1729-135
1729-144
2136-33
2292-96
3432-12
3432-37
3432-50
3525-41
3525-56
3525-57
4524-42
4591-71
4829-26
4829-53
4829-54
4829-60
4829-62
4829-64
4829-68
4829-69
4875-15
5185-54
5185-194
5185-226
5185-278
5185-315
5185-316
5185-319
5736-43
6199-2
6199-4
6284-3
6284-20
6284-27
6284-28
6284-42
6284-52
6809-8
7124-20
7124-31
7152-17
7152-21
7364-45
7364-60
7368-6
7368-37
7616-2
7616-47
8033-6
8544-10
8544-13
8544-20
8791-4
8791-12
8791-27
8791-31
8791-43
-------
8791-44
SS66-24
8959-38
8959-40
9157-5
9157-18
9157-23
9157-28
9157-31
9215-2
9215-8
9411-7
10079-3
10133-11
10182-10
10182-13
10182-31
10182-59
10336-3
10598-8
10897-1
10897-7
10897-9
10897-31
10932-10
11329-8
11411-1
12014-27
12014-42
12014-44
12465-51
15127-9
15127-10
15127-11
33906-1
33908-4
33906-5
33906-7
33980-2
33980-3
34571-14
35909-10
36234-3
37428-1
37982-19
37982-23
41134-1
41134-3
41134-5
41702-6
41702-12
42177-8
42177-18
42177-30
42177-57
42177-58
, 42448-3
43973-2
43973-5
45309-12
45309-46
45387-15
47033-7
48242-1
51624-3
53254-2
53254-3
53346-1
53346-2
8
-------
53346-3
53348-4
54309-14
54998-2
57787-6
57787-9
57787-16
62498-1
Table II.
^ Trichloroisocyanurates and any other active
ingredient
4829-80
4829-81
4829-82
4829-83
4829-84
4829-85
6284-43
6284-46
7124-1
7124-6
7124-37
7124-42
7124-61
7124-62
7124-63
7124-64
7124-68
7124-66
7124-67
7124-68
7124-69
83.7
83.7
63.7
63.7
63.7
63
63
63
66
68
67
70
66
66
66
66
65
65
65
65
65
able
able
table
able
tablets
able
able
granule
tablaM
tablau
tablets
tablet«
tablau
tablet*
tablet*
tablet*
tablets
-------
Batch
28
EPA Rag. No.
7152-43
7152-87
7364-42
8544-4
8791-29
12465-16
42177-68
45309-7
45309-8
45309-15
45309-2O
45309-52
1258-1187
1258-1188
1258-1189
1258-1191
4829-116
4829-117
4829-118
5185-349
5185-397
7124-15
7618-8
7618-51
8791-0
8791-61
8791-62
8791-63
8791-64
9291-6
42177-47
% Trichloroisocyanurates and any other active
ingredient
66 !
66
60 !
70
67
67 • !
67 ;
67
67
67 ;
67 i
67
78.0
78.6
78.6
78.6
78
78
78
89
86.3
81
82
82
80
70
70
80
80
63
89
Formulation Type IJ
granular ]|
tablet
tablets
granular
tablet*
tablets ||
tablets
tablets II
tablets 1
tablets • ||
tablets ||
tablets ||
I
stick
tablets
tablets
granular
tablets
tablets
tablets
tablets
tablets I
granular ||
tablets
tablets
tablets
tablets
tablets
tablet*
tablets
tablet*
_ _______ —^—j
tablet* I
10
-------
Batch
29
30
EPA Reg. No.
42177-48
42177-50
42177-52
4582-65
4582-66
4582-67
524-394
524-402
524-410
524-41 1
524-425
6284-29
% Trichioroisocyanurates and any othar active
ingredient
89
89
89
0.6
0.6
0.6
Trichloroisocyanurate 92
Sodium bromide 7
Trichloroisocyanurate 92
Sodium bromide 7
Trichloroisocyanurate 92
Sodium bromide 7
Trichloroisocyanurate 92
Sodium bromide 7
Trichloroisocyanurate 88
Sodium bromide 9.2
TricWoroisocyanurate 96
Formulation Type
tablets
tablets
stick
powder
powder
powder
tablets
tablets
tablets
tablet*
tablets
tablet*
Batch 31: The following batch consist of products (sticks, tablets and granular formulations)
containing trichloroisocyanurates as the active ingredient in concentrations ranging
from 93- 100% .
148-916
148-1279
148-1280
148-1281
230-47
230-48
230-58
230-69
230-61
230-79
230-80
230-81
230-82
230-83
230-84
230-85
230-87
524-107
524-323
524-324
524-336
524-337
524-348
524-374
524-380
524-387
524-399
524-414
524-438
1258-853
1258-855
1258-893
1258-905
1258-922
1258-992
1258-993
1258-994
1258-995
1258-996
1258-997
1258-998
1258-1059
1258-1060
1258-1061
1258-1062
1258-1075
1258-1083
1258-1133
1729-92
1729-95
1729-98
1729-99
1729-100
1729-101
1729-120
1729-138
1729^143
11
-------
1729-145
1729-14S
3432-23
3432-24
3432-35
3432-36
3432-44
3432-43
3432-51
3432-61
3525-38
3525-42
3525-72
3525-73
3525-74
3525-75
3525-76
3878-138
4591-72
4843-47
4827-77
4829-55
4829-59
4829-61
4829-63
4829-67
4829-74
4829-75
4829-86
4829-87
4829-89
4829-125
5185-10O
5185-114
5185-143
5185-144
5185-159
5185-318
5185-348
5185-351
§185-352
5185-370
5185-371
5185-379
6199-3
6199-5
6284-11
6284-12
6284-19
6284-26
6284-31
6284-32
6284-33
6284-35
6284-36
6284-37
7124-12
7124-14
7124-18
7124-22
7124-24
7124-44
7124-53
7124-70
7124-71
7124-72
7124-95
7124-99
7152-39
7364-41
7364-43
7364-44
7364-49
7364-51
7364-55
7364-57
7368-19
7368-21
7368-27
7369-61
7368-70
7616-18
7616-28
7616-50
7616-60
7619-39
8033-4
8544-11
8544-12.
8544-15
8791-2
8791-3
8791-6
8791-7
8791-11
8791-26
8791-28
8791-32
8791-33
8791-36
8791-37
8791-38
8791-42
8866-25
8959-42
9157-6
9157-17
9157-27
9157-29
9157-32
9157-35
9215-3
9215-6
9215-7
10182-11
10182-12
10182-32
10182-33
10182-42
10182-51
10182-52
10182-53
10182-54
10182-55
10336-7
10598-7
10707-37
10897-2
10897-8
10897-11
10897-16
10897-17
10897-30
11329-9
11411-3
11411-5
11411-6
11411-7
11411-8
12014-35
12014-36
12014-37
12014-39
12014-40
12014-45
12014-56
12465-36
12465-39
12465-48
12477-11
13812-3
15127-4
15300-21
27581-31
33458-15
33906-2
33906-3
33906-6
33980-1
33980-4
33980-5
33980-6
34571-12
36284-1
36284-4
36284-6
37428-3
37982-4
37982-6
41134-2
41134-4
41702-7
41702-8
41702-9
42177-17
42177-18
42177-22
42177-23
42177-24
42177-26
42177-36
42177-67
43973-3
43973-4
45309-9
45309-16
12
-------
45309-22
45309-23
45309-24
45309-27
45309-47
45309-48
45309-51
45387-13
45387-16
45387-17
45387-18
47033-8
48242-2
48242-4
48520-10
48520-11
53254-1
53254-5
53254-6
53735-2
53735-3
53735-4
53735-5
53735-6
54998-1
54998-3
54998-6
57091-1
57091-2
57787-1
57787-8
57787-12
62498-3
62498-4
62498-5
63041-1
Table III.
% Diohloroi«ocyanurate« and any other active
ingredient
Formulation Type
dichioroisocyanuratt
citric acid
36.7 dichloroitocyanurate
8.7 copper sulfate
13
-------
% Dichloroitocyanurates and any other activs
ingredient
dichloroisocyanurate
potassium iodine
Table IV shows 19 products containing trichloroisocyahurates as the active ingredient and that were
either considered not to be similar for purposes of acute toxicity or the Agency lacked sufficient
information for decision making and were not placed in any batch. Registrants of these products are
responsible for meeting the acute toxicity data requirements for each product.
Table IV.
EPA Rtfl. No.
••••••
541-173
Trichloroitocyanurate*
•Mi
10
Formulation Type
•MHI
powder
t02O-4
USS-909
4843-29
4829-94
SI 85-400
7124-2
7124-50
62
25
38.8
93.33
30
50
granular
granular
solution
tabUU
tablet*
tablet*
granular
14
-------
EPA Rag. No.
7152-33
7152-34
7152-37
7616-48
8791-1
9157-33
10147-10
15300-17
37982-22
46043-2
46043-3
Trichloroisocyanurata*
99
99
99
30.3
79
70
15
20
99
99
99
Formulation Type
tablet*
tablet*
tablets
tablet*
granular
tablet*
granular
powder
granular
tablets
tablets
15
-------
-------
ATTACHMENT E
List of All Registrant(s) Sent This Data Call-In Notice
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ATTACHMENT F
EPA Acceptance Criteria
-------
-------
SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
-------
61 Product Identity and Composition
I
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and
trade name, if appropriate)
2. Name, nominal concentration, and certified limits (upper and
lower) for each active ingredient and each intentionally-
added inert ingredient
3. Name and upper certified limit for each impurity or each
group of impurities present at > 0.1% by weight and for
certain toxicologically significant impurities (e.g.,
dioxins, nitrosamines) present at <0.1% ;
4. Purpose of each active ingredient and eachf intentionally-
added inert ; •
5. Chemical name from Chemical Abstracts index of Nomenclature
and Chemical Abstracts Service (CAS) Registry Number for each
active ingredient and, if available, for each intentionally-
added inert I
6. Molecular, structural, and empirical formulas, molecular
weight or weight range, and any company assigned experimental
or internal code numbers for each active ingredient
7. Description of each beginning material in the manufacturing
process
EPA Registration Number if registered; for other
beginning materials, the following:
Name and address of manufacturer or supplier
'_ Brand name, trade name or commercial designation
~~~~~" Technical specifications or data sheets by which
manufacturer or supplier describes composition,
properties or toxicity !
8. Description of manufacturing process
Statement of whether batch or continuous process
~~~~ Relative amounts of beginning materials and order in
which they are added
Description of equipment
Description of physical conditions (temperature,
pressure, humidity) controlled in each step and the
parameters that are maintained
Statement of whether process involves intended chemical
reactions
.J
-------
8. (continued)
Flow chart with chemical equations for each intended
chemical reaction
Duration of each step of process
Description of purification procedures
Description of measures taken to assure quality of final
product
9- Discussion of formation of impurities based on established
chemical theory addressing (1) each impurity which may be
present at > 0.1% or was found at > 0.1% by product analyses
and (2) certain toxicologically significant impurities
(see #3)
-------
61 Product Identity and composition
GUIDANCE FOR SUMMARIZING STUDIES !
The following criteria apply to the technical grade of the active
ingredient being reregistered. Items 1, 2, 3, and 5 can be
satisfied for most registered products by submission of the
Certified Statement of Formula Ingredients Page (EPA Form 8570-4).
Items 7 and 8 can be satisfied for most technical grade active
ingredients (TGAIs) by submission of a flow chart with chemical
equations for each intended chemical reaction. The flow chart
should include complete chemical structures and names for each
reactant and product.of all the reactions. j
1. Name of technical material (include product name and trade name,
if appropriate).
2. Description of each active and intentionally-added inert
ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert
ingredient. ;
5. Chemical name and Registry Number for each active and
intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
and any experimental or internal code number for each active
ingredient.
7. Description of each beginning material in the manufacturing
process.
8. Description of manufacturing process. |
9. Discussion of formation of impurities based on established
chemical theory.
-------
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of
batch process) analyzed for each active ingredient and all
impurities present at > 0.1%
2. Degree of accountability or closure > ca 98%
3. Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines' both fresh and stored
samples must be analyzed.]
4. Complete and detailed description of each step in analytical
method used to analyze above samples
5. Statement of precision and accuracy of analytical method
used to analyze above samples
6. Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient
7. Upper and lower certified limits proposed for each active
ingredient and intentionally added inert along with
explanation of how the limits were determined
8. Upper certified limit proposed for each impurity present at
> 0.1% and for certain toxicologically significant
impurities at <0.1% along with explanation of how limit
determined
9. Analytical methods to verify certified limits of each
active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally
recognized as safe by FDA) are fully described
10. Analytical methods (as discussed in #9) to verify certified
limits validated as to their precision and accuracy
-------
62 Analysis and Certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
!
I
1. Number of representative samples analyzed for all active
ingredients and all impurities at > 0.1%.
2. Degree of accountability or closure in analyses in item #1.
3. Chemical names of toxic impurities which were analyzed for
levels <0.1%. ;
4. Brief description(s) of analytical method(s) used to measure
active ingredients and impurities in items #1 and #3.
5. statement of precision and accuracy of method(s) in item #4.
6. Chemical name and quantities observed (range, mean, standard
deviation) for each ingredient (actives and impurities)
analyzed in item #1. j
7. Proposed upper and lower certified limits for each active
ingredient and intentionally added inert with brief explanation
of how limits were determined.
8. Proposed upper certified limit for each impurity present at
>=oTl% and certain toxicologically significant impurities at
<0.1% with brief explanation of how limits were determined.
i n.
9. Brief description of analytical method(s) used to verify
certified limits (if same methods as item #4, may reference
latter).
I
10. Statement of precision and accuracy of method(s) in item #9
(may reference item #5 if applicable).
-------
63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of
Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms
such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms
such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
!•-
63-5 Melting Point
Reported in Ce
Any observed decomposition reported
63-6 Boiling Point
Reported in C°
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in
g/ml ox the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of
registered products may be reported in Ibs/ft or
Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and
non-polar solvents, including those used in formulations
and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if
sparingly soluble)
-------
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from
measurements made at higher temperature if pressure too
low to measure at 25° C) •
Experimental procedure described j
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
~~~~ Temperature of measurement specified (preferably
about 20 - 25° C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure
provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20 - 25° C
' Measured following dilution or dispersion in distilled
water I
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
8
-------
63 Physical and Chemical Characteristics
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Description of color.
2. Description of physical state.
3. Description of odor.
4. Indication of melting point (in C°).
5. Indication of boiling point (in C°).
6. Indication of density, bulk density, and specific gravity.
7. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH.
12. Description of stability.
-------
SUBDIVISION F
Guideline Study Title |
81-1 Acute Oral Toxicity in the Rat ;
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study :
81-6 Dermal Sensitization in the Guinea Pig
81-7 Acute Neurotoxicity in the Hen ;
10
-------
81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 young adult rats/sex/group
3. Dosing, single oral may be administered over 24 hrs.
4.*. Vehicle control if other than water.
5- Doses tested, sufficient to determine a toxicity category
or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all
test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
11
-------
81-1 Acute Oral Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g. solid, liquid, percent
AI in technical, end-use product, etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9. Significance of changes from the Acceptance Criteria
12
-------
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
At least 5 animals/sex/group
Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-
450 gm.
Dosing, single dermal.
Dosing duration at least 24 hours.
Vehicle control, only if toxicity of vehicle is unknown.
Doses tested, sufficient to determine a toxicity category
or a limit dose (2000 ing/kg).
Application site clipped or shaved at least 24 hours
before dosing
Application site at least 10% of body surface area.
Application site covered with a porous nonirritating cover
to retain test material and to prevent ingestion.
Individual observations at least once a day.
Observation period to last at least 14 days.
Individual body weights.
Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
13
-------
I
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
|
1. The form of pesticide tested, e.g., solid,jliquid, percent AI
in technical, end-use product, etc. :
2. The number of animals/sex/dose
3. Weight range of animals
4. Verification of single, dermal exposure
5. Duration of dermal exposure
6. Statement of vehicle control
7. Doses tested and results I
8. Preparation of application site |
9. Area of application site (percent body surface)
10. Occlusion of test material on application site
11. Individual observations on day of dosing and for at
least 14 days or until all animals appear normal (whichever is
longer).
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
14
-------
81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
!• Identify material tested (technical, end-use product, etc)
2- Product is a gas, a solid which may produce a significant
vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter
15 urn or less).
3. At least 5 young adult rats/sex/group
4. Dosing, at least 4 hours by inhalation.
5- Chamber air flow dynamic, at least 10 air changes/hour, at
least 19% oxygen content.
6- Chamber temperature, 22° C (±2), relative humidity 40-60%.
7. Monitor rate of air flow
8. Monitor actual concentrations of test material in breathing
zone.
9- Monitor aerodynamic particle size for aerosols.
1°« Doses tested, sufficient to determine a toxicity category
or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
15
-------
81-3 Acute Inhalation Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. Statement of the inhalability of test substance
3. The number of animals/sex/dose
4. Duration of inhalation exposure ;
5. Number of chamber air changes/hour and the percent oxygen
content of chamber air
6. Ranges for chamber air temperature and relative humidity
7. Air flow rate
8. Analytical concentrations of test material in breathing zone
9. Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
11. Individual observations on day of dosing and for at least 14
days.
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
16
-------
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5- Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if
a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal or
21 days (whichever is shorter).
9.*. individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
17
-------
81-4 Primary Eye Irritation in the Rabbit
r
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, cause severe dermal irritation
or has a pH of <2 or >11.5
3. Number of adult rabbits tested
4. State method of dosing, i.e., instillation into the
conjunctival sac of one eye per animal
5. Dose administered >
6. Note whether solid or granular test material has been ground to
a fine dust
7. State whether eyes were washed and at what time post
Instillation (not less than 24 hours)
8. State whether eyes were examined and graded for irritation
before dosing and at what periods after dosing
9. Individual daily observations afterwards, until eyes are normal
or for 21 days
10. Significance of changes from Acceptance Criteria
18
-------
81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
I- Identify material tested (technical, end-use product, etc)
2- Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6- Application site shaved or clipped at least 24 hours prior
to dosing
7. Application site approximately 6 cm.
8' Application site covered with a gauze patch held in place
with nonirritating tape
9- Material removed, washed with water, without trauma to
application site
10 • Application site examined and graded for irritation at 1,
24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11.*, Individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
19
-------
81-5 Primary Dermal Irritation Study
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, has a pH <2 or >11.5, or has
a dermal LD 50 <200 mg/kg
3. Number of adult animals tested
4. Amount applied [
5. Duration of dermal exposure I
6. Preparation of application site (shaved or clipped at
specified time before dosing)
7. Area of application site
8. Method for occlusion of application site
9. Note removal of test material and if skin was washed with
WSltS
10. State times post application when site was graded for
11. Individual observations for day of dosing and individual
daily observations thereafter
12. Significance of changes from Acceptance Criteria.
20
-------
81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
dose your study meet the following acceptance criteria?
!• Identify material tested (technical, end-use product, etc)
2- Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3. One of the following methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig
4. Complete description of test
5.*. Reference for test.
6- Test followed essentially as described in reference
document.
7- Positive control included (may provide historical data
conducted within the last 6 months)
Criteria marked with a * are supplemental and may not be required
for every study.
21
-------
81-6 Dermal Sensitizatidn in the Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. Complete description of specific method !
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria
22
-------
81-7 Acute Neurotoxicity in the Hen
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Study performed on an organophosphate cholinesterase
inhibiting compound.
2. Technical form of the active ingredient tested.
3.*. Positive control utilized.
4. Species utilized, domestic laying hen 8-14 months of age.
5. Dosing oral by gavage or capsule (dermal or inhalation
may be used).
6. An acute oral LD is determined.
7. Dose tested equal to an acute oral LD or a limit test of
5000 mg/kg.
8.*. Dosed animals may be protected with atropine and/or 2-
PAM.
Sufficient test animals so that at least 6 survive.
Negative (vehicle) control group of at least 6 hens
Positive control of at least 4 hens, (if used)
Test dose repeated if no signs of delayed neurotoxicity
observed by 21 days after dosing.
Observation period 21 days after each dose.
Individual daily observations.
Individual body weights.
Individual necropsy not required.
Histopathology performed on all animals. Tissue to be
fixed in sin preferably using whole animal perfusion
techniques. At least three sections of each of the
following tissues:
_brain, including medulla oblongata
"spinal cord; upper cervical, mid-thoracic and
"lumbro-sacral regions
tibial nerve; proximal regions and branches
sciatic nerve
Criteria marked with a * are supplemental and may not be required
for every study.
23
-------
-------
ATTACHMENT G
Cost Share and Data Compensation Forms
-------
-------
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Fona Approved
OUt No. 2070-
Approval Explroa 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.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 Nama
Product HUM
Company Numbar
BPA R*g. No.
I Certify that:
1. For each study cited in support of registration or reregistratton 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 reregistratton under FIFRA that is NOT an exclusive use
study. I am the original data submitter, or I have obtained the written permission of the original data submitter, or I
have notified in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(c)(1)(D) and 3(c)(2)(D) of FIFRA: and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, if any. The companies I have notified are: (check one)
I ] 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)(i )(D) of FIFRA for the studies I have cited in support of
registration or reregistratton under FIFRA.
Signature
Data
Nana and Till* (Plaaaa Typo or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistratton of my products, to the extent required by FIFRA sections 3(c)(1)(D) and 3(c)(2)(D).
Signature _ .
Data
Nama and Tftla (Plaaaa Typa or Print)
EPA Form 1570-31 (4-90)
-------
r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
OVI Me. 1070-0107
2070-0057
Approval Ciplr**
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.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Pleise fill In blanks below.
Company Nam*
product Mao*
F
Company Number
EPA R»g. MO.
I Certify that:
My company is willing to develp 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 developing
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) of FIFRA 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(a)
Dal* of Offer
Cert'rffcatfon: i
I certify that I am duly authorized to represent the company name above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
SIgnalur*
Nam* and
of Company'* Authorized R*pr***ntatlv*
i
0*1*
Tltl* (Picas* Typ* or Print) ,
EPA Form §S70-32 (S-tl)
R*plao*» EPA Form 1580-6, which I* obaolct*
-------
LABEL
PRESENTED BY JERRY A. MOORE. ACTING CHIEF, EPA STANDARDS AND LABELING.
EPA'S SECTION 3 REGULA-
TIONS KEYED FOR BOTH RE-
STRICTED USE AND GENERAL
The pesticide label is the final result of the registration
and/or registration process and reflects the risks and
benefits of a given pesticide to the user. The label is not
only the primary source of information to the user, it is
also the primary tool of pesticide regulation. The label, in
a sense, is a legal document. Improvement of pesticide
labels benefits both the industry and the public.
The reregistration process provides for overall
improvement in labels. Certain of the.changes in label are
requirements, other changes-are recommendations. The
charts that follow will clearly indicate what is required
and what is preferred. It is hoped that avoidance of
all-inclusive requirements will allow flexibility in those
labels which may not fit the more standard situations.
The Section 3 Regulations require that certain statemems
must appear at certain locations on the label. The
designation of specific areas of the label for specific
information is known as format labeling. This is not a
new concept, i.e.. signal words have been required to
appear on the front panel. The application of the concept
to the entire label is new. If pesticide users know to look
at the same locations or, labels for certain kinds of
information, we should be able to better train and educate
people, thus improving the understanding of the proper
use of pesticides. We ask your cooperation in making the
format label a viable concept. We recognize the potential
conflict between marketing concepts of product identity
and the standardization which results from format
labeling. However, the primary purpose of the pesticide
label is a means of use communication and regulation.
Marketing is a secondary purpose, although a very real
purpose. Leeway for product individuality is provided in
format labels, but only with the recognition that the label
is a legal document to instruct the user on use and safety
REST°Rir-rln ""Tu ?"" * 't* leeway in the cas€ <*
RESTRICTED use labels since these products are not for
use by the general public.
The tables on the following pages outline the basic
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jize C! LUUCI
on Front Panel
in Square Inches
oignal Wora as rcequir'ed
Minimum Type Size
All Capitals
'Keep >ut of Reac-
as Required
5 and under
above 5 to 1 0
above 1 0 to 15
above 15 to 30
over 30
A point
10 point
1 2 point
14 point
1 8 point
1 2 ooint
=- 3
-BODONI BOLD 18 & 12 Pt.-
.POISON . DANGER . WARNING . CAUTION.
KEEP OUT OF REACH OF CHILDREN
Keep Oat of Reach of Children
=- 5
-BOOONI BOLD 14 & 10 Pt.-
.POISON . DANGER . WARNING . CAUTION.
KEEP OUT OF REACH OF CHILDREN
Keep Ov< •( Reach of Children
~ o
-BODONI BOLD 12 & 8 Pt.-
.POISON . DANGER . WARNING . CAUTION.
KEEP OUT OF REACH OF CHILDREN
Keep Oat of Reach of Chlldroi
-BODONI BOLD 10 & 6 Pu-
.POISON . DANGER . WARNING . CAUTION.
KCCF
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U.S. GOVERNMENT PRINTING OFFICE: 1993-515-003-87109
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