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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unpublished materials submitted to the Agency the Agency has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
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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) ]•
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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:
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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
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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.
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LABEL FORMAT FOR UNCLASSIFIED PRODUCTS
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LABEL FORMAT FOR PRODUCTS CLASSIFIED FOR RESTRICTED L'CE
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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