I
REREGISTRATIQN ELIGIBILITY DOCUMENT
SODIUM AND CALCIUM HYPOCHLORITE SALTS
LIST A
CASE 0029
FEBRUARY 1992
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
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TABLE OF CONTENTS
PAGE
GLOSSARY OF TERMS AND ABBREVIATIONS i
EXECUTIVE SUMMARY iii
I. INTRODUCTION 1
II. ACTIVE INGREDIENTS COVERED BY THE REREGISTRATION DECISION 2
DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENT 2
B. USE PROFILE 2
C. REGULATORY HISTORY 3
III. AGENCY ASSESSMENT OF ACTIVE INGREDIENT . 5
A. PRODUCT IDENTIFICATION 5
B. HUMAN HEALTH ASSESSMENT 5
1. TOXICOLOGY DATA 5
2. DIETARY EXPOSURE 6
a. RESIDUE DATA 6
b. TOLERANCE REASSESSMENT 7
3. OCCUPATIONAL AND RESIDENTIAL EXPOSURE 7
4. RISK ASSESSMENT 8
C. ENVIRONMENTAL ASSESSMENT 8
1. ECOLOGICAL EFFECTS ASSESSMENT 9
2. ENVIRONMENTAL FATE ASSESSMENT 10
IV. REREGISTRATION DECISION FOR SODIUM AND CALCIUM
HYPOCHLORITE SALTS 12
A. DETERMINATION OF ELIGIBILITY 12
B. ADDITIONAL GENERIC DATA REQUIREMENTS 13
C. LABELING REQUIREMENTS 13
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V. PRODUCT REREGISTRATION 14
A. DETERMINATION OF ELIGIBILITY 14
B. PRODUCT-SPECIFIC DATA REQUIREMENTS • 15
C. LABELING REQUIREMENTS 16
VI. APPENDICES
A, APPENDIX A - DETAILED SPECIFIC USE SITES 19
8. APPENDIX B - GENERIC DATA REQUIREMENTS FOR REREGISTRATION
OF SODIUM AND CALCIUM HYPOCHLORITES AND DATA CITATIONS
SUPPORTING REREGISTRATION
1. GUIDE TO APPENDIX B 26
2. PRODUCT IDENTIFICATION (SODIUM HYPOCHLORITE) 27
3. ECOLOGICAL EFFECTS (SODIUM HYPOCHLORIT1) 28
4. TOXICOLOGY (SODIUM HYPOCHLORITE) 29
5. ENVIRONMENTAL FATE (SODIUM HYPOCHLORITE) 30
6. PRODUCT IDENTIFICATION (CALCIUM HYPOCHLORITE) 31
7. ECOLOGICAL EFFECTS (CALCIUM HYPOCHLORITE) 32
8. TOXICOLOGY (CALCIUM HYPOCHLORITE) 33
9. ENVIRONMENTAL FATE (CALCIUM HYPOCHLORITE) 34
B. APPENDIX'C - BIBLIOGRAPHY
1. GUIDE TO APPENDIX C 36
2. BIBLIOGRAPHIC CITATIONS 38
D. APPENDIX D - PR Notice 91-2 45
E. APPENDIX E - DATA CALL-IN
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
a, i.
ARC
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HOT
K+CWHR
LC50
LD50
LOT
LEL
MP
MPI
Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Highest Dose Tested
Kernel plus Cob with Husk Removed
Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or volume
of water or feed, e.g., mg/1 or ppra.
Median lethal dose - a statistically derived single dose
that can be expected to cause death in 50% of the test
animals, when administered by the route indicated (oral,
dermal, inhalation). It is expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
Lowest Dose Tested
Lowest Effect Level
Manufacturing Use Product
Maximum Permissible Intake
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GLOSSARY OF TERMS AND ABBREVIATIONS CONT'D
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts per Million
RfD Reference Dose
RS Registration Standard
TMRC Theoretical Maximum Residue Contribution
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Executive Summary
The Environmental Protection Agency (referred to as "the
Agency") first registered sodium and calcium hypochlorites as
chlorinated inorganic disinfectants for use as sanitizers and
disinfectants of surfaces, as disinfectants of water, and as
chemicals to control microorganisms on certain foods and in certain
industrial processes. All products which contain sodium and
calcium hypochlorite as an active ingredient are eligible for
reregistration except the uses on sugar syrup and raw sugar (the
processed commodity). The uses on sugar syrup and raw sugar (the
processed commodity) for calcium hypochlorite as well as for sodium
hypochlorite are not eligible for reregistration without the
acquiring of a food additive regulation from FDA.
In February 1986, the Agency issued a registration standard
entitled "Guidance for the Reregistration of Pesticide Products
Containing As the Active Ingredient Sodium and Calcium Hypochlorite
Salts" {NTIS PB87-103222) . The Registration Standard summarized
the available data supporting the registration of sodium and
calcium hypochlorite and determined that the data base was
complete. No additional data were required for the generic data
base in the 1986 Standard. The requirements listed in the Standard
were cited only for those applicants who wanted to develop their
own supporting data rather than rely upon and offer to pay
compensation for the data cited in the Standard.
Recently, the Agency conducted a thorough review of the
scientific data base and all relevant information supporting the
reregistration of sodium and calcium hypochlorite and has
determined that the data base is complete and is sufficient to
allow the Agency to conduct a reasonable risk assessment. No
further generic data are required. The data available to the
Agency support the conclusion that the currently registered uses of
sodium and calcium hypochlorites will not result in unreasonable
adverse effects to the environment. No tolerances are required by
the Agency to support the existing uses for the registered products
because sodium hypochlorite is listed as GRAS (40 CFR 130.2) and
calcium hypochlorite is exempt for the requirement of a tolerance
under FFDCA sec. 408 (40 CFR 180.1054). It should be noted,
however, that even though sodium hypochlorite is listed as GRAS (40
CFR 180.2) and calcium hypochlorite is exempt under Section 408 of
the FFDCA from the requirements of a tolerance for use preharvest
or postharvest on raw agricultural commodities, these exemptions do
not cover the uses of sodium and calcium hypochlorite as food
additives In or on processed foods which is regulated under Section
409 of the FFDCA. The 1986 Standard required registrants to obtain
a food additive regulation for calcium hypochlorite in sugar syrup
and raw sugar (the processed commodity) from FDA within 12 months
from the date of issuance of the Standard or delete the claim from
the appropriate product labeling. Since this regulation was not
obtained, these uses must be deleted from the appropriate calcium,
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as well as sodium hypochlorite product labeling within 8 months of
the date of this document or be subject to enforcement action.
Accordingly, the Agency has determined that ' all products
containing sodium and calcium hypochlorites as the active
ingredient are eligible for reregistration except the uses on sugar
syrup and raw sugar (the processed commodity) and will be
reregistered when appropriate labeling and/or product specific data
are submitted and/or cited. Those products which contain other
active ingredients will be eligible for reregistration only when
the other active ingredients are determined to be eligible for
reregistration.
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I. INTRODOCTIOH
In 1988, the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) was amended to accelerate the
reregistration of products with active ingredients registered
prior to November 1, 1984. The amended Act provides a
schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration
process. The first four phases of the process focus on
identification of data requirements to support the
reregistration of an active ingredient and the generation and
submission of data to fulfill the requirements. The fifth
phase is a review by the U.S. Environmental Protection Agency
(referred to as "the Agency") of all data submitted to support
reregistration.
Section 4 (g) (2) (A) of FIFRA states that in Phase 5
"the Administrator shall determine whether pesticides
containing such active ingredient are eligible for
reregistration" before calling in data on products and either
reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of
the scientific data base underlying a pesticide•s
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding
the reregistration of sodium and calcium hypochlorite. The
document consists of five sections. Section I is this
introduction. Section II describes sodium and calcium
hypochlorite, its uses and regulatory history. Section III
discusses the human health and environmental assessment based
on the data available to the Agency. Section IV discusses the
reregistration decision for sodium and calcium hypochlorite
and Section V discusses product reregistration. Additional
details concerning the Agency's review of available data are
available on request.
SPA's reviews of specific reports and information on the
set of 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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i
II. ACTIVE INGREDIENT COVERED B¥ THIS REREGISTRATION DECISION
DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENT
The following active ingredients are covered by this
Reregistration Eligibility Document:
Chemical Name: Sodium Hypochlorite
CAS Number: 7681-52-9
Office of Pesticide Programs Chemical Code Number: 014703
Empirical Formula: NaOCl
Chemical Name: Calcium Hypochlorite
CAS Number: 7778-54-3
Office of Pesticide Programs Chemical Code Number: 014701
Empirical Formula: CaOCl2
B. USE PROFILE
Type of Pesticide: Chlorinated Inorganic Disinfectants
Pests Controlled: Bacteria, fungi, and slime forming
algae that are pathogenic to man and animals
Registered Use Groups: (See Appendix A for detailed
specific use sites) .
For Sodium Hvpochlorites
Terrestrial Food Crop: citrus, apples, pears,
quinces, stone fruits, cherries, nectarines,
peaches, pecans, plums/prunes, melons, cucumbers,
peppers, pimentos, tomatoes (postharvest
application/seed treatment) , brussels sprouts ,
cabbage, cauliflower, 'artichokes, lettuce, carrots,
potatoes, radishes, sweetpotatoes , asparagas,
mushrooms, onions, celery, peppers (seed treatment)
Terrestrial Feed Crop: citrus, apples, tomato«»
(postharvest application/seed treatment)
Terrestrial Non-Food
Aquatic Food Crop
Aquatic Non-Food Residential
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Aquatic Non-Food Outdoor
Aquatic Non-Food Industrial
Indoor Food
Indoor Non-Food
Indoor Residential
Indoor Medical
Residential Outdoor
For Calcium Hvpochlorite
Terrestrial Food Crop; pecans (water treatment),
pecan (postharvest application to non-stored
commodities), pimentos (seed treatment),tomatoes
(seed treatment), potatoes and sweet potatoes
(postharvest application to non-stored
commodities), mushrooms (foliar or soil treatment),
vegetables or post harvest application to
vegetables crops, fruit or post harvest application
to fruit crops, seeds (Agricultural),
Terrestrial Feed Crop: seeds (Agricultural)
Terrestrial Non-Food Crop
Aquatic Food Crop
Aquatic Non-Food Industrial
Aquatic Non-Food Residential
Aquatic Non-Food Outdoor
Indoor Food
Indoor Non-Food
Indoor Residential
Indoor Medical
Residential Outdoor
Formulation Types Registered:
For Sodium Hypoc^lgritf_; Formulation intermediate,
granular, wettable powder, emulsifiable
concentrate, soluble concentrate, solution-ready to
use.
For Calcium Hypochloritf: Formulation intermediate,
dust, granular, pelletted/tabletted, wettabl»
powder, wettable powder/dust, soluble concentrate,
solution-ready to use.
REGULATORY HISTORY
Sodium and calcium hypochlorites are well known
compounds whose chemical and toxicological properties ar*
extensively documented in published literature and
studies submitted to the Agency. In February 198«, *
Registration Standard was issued for sodium and calcius
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hypochlorite which summarized the available data
supporting their registration. The standard concluded
that no additional scientific data would be necessary to
support the registration or reregistration of products
which contain sodiua hypochlorite from 5.25% to 12.5% or
calcium hypochlorite from 65% to 70% as the only active
ingredient, provided that no inert ingredients other than
water were added and that Toxic ity Category I labeling is
used. The Registration Standard provided various options
to applicants who wanted to register or reregister sodium
or calcium hypochlorite products. The options
implemented were;
1) Option I; Reliance on available data to support
registration of toxicity category I products and
adopt the generic labeling provided by the Agency.
(This option was the "general registration"
procedure designed to reduce processing time and
costs to the Agency and registrants, while
continuing to assure human and environmental
protection. Only products containing 5.25%, 9.2%,
10%, or 12.5% sodium hypochlorite, or 65% calcium
hypochlorite as the sole active ingredients were
eligible for this option) .
2) Opt j.on I| ; Either reliance on available data to
support registration of toxicity category I
products and submit their own labeling or
development of data independently to support
registration of toxicity category I products and
submit their own specific labeling,*
3) Option Ij%; Development of product specific data
independently by registrants to support lower
toxicity categories II, III, or IV.
Manufacturing-use sodium hypochlorite and calcium
hypochlorite products were defined by the standard as
12.5% and 65%, respectively? and product chemistry and
acute toxicity data developed with these formulations
also could be used to support end-use products of the
same concentrations. The product chemistry and acute
toxicity data developed with these formulations would
also be extrapolated to support end-use concentrations of
sodium hypochlorite down to 5.25%, since they are simply
aqueous dilutions of the 12.5% manufacturing-use product.
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IZZ. AGENCY ASSESSMENT OP ACTIVE INGREDIENT
The Agency has conducted a thorough review of the
scientific data base for sodium and calcium hypochlorite.
Based on the evaluation of these data, the Agency has no
reason to change the major findings made in the 1986
document "Guidance for the Reregistration of Pesticide
Products Containing as the Active Ingredient Sodium and
Calcium Hypochlorite Salts". These findings are
summarized below:
A. PRODUCT IDENTIFICATION
In the 1986 Registration Standard, no additional data
were required on the product chemistry of sodium or
calcium hypochlorite. The product chemistry data
requirements listed in the standard were listed only for
those applicants who wished to develop their own data
rather than rely upon and offer to pay compensation for
data cited in the standard. Calcium hypochlorite is a
dull white powder with a strong odor of chlorine. It is
a strong oxidant and has a critical ignition temperature
of about 75* C. It decomposes violently above 150" C.
This chemical has a molecular weight of 142.99. Sodium
hypochlorite is produced as a greenish-yellow liquid with
the smell of chlorine. It is inherently unstable and its
decomposition is hastened principally by light, heat and
trace metals. It is moderately corrosive and specific
packaging is essential. Sodium hypochlorite is a strong
oxidizing agent. This chemical has a molecular weight of
74.44 (anhydrous). The Agency has reevaluated the
product chemistry data base and has determined that no
additional data are required for reregistration for
products that were subject to the standard.
B. HUMAN HEALTH ASSESSMENT
1. Toxicology Data Base
All current toxicological data requirements are
satisfied. No further data were required in the 1986
registration standard (provided that toxicity category I
labeling was used). The Agency has reevaluated the
scientific data base for sodium and calcium hypochlorite
and finds that the database for the purpose of human risk
assessment is complete and no additional data are
required. The available acute toxicity data are
sufficient to address the acute toxicity risk to humans
and the Agency has concluded that toxicity category I
labeling is appropriate due to sodium and calcium
hypochlorite'a known potential for causing damage to
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eyes. The Agency also concludes that no subchronic or
chronic studies are needed. This conclusion is based on
the simple chemical nature and structure of sodium and
calcium hypochlorites and their high oxidative reactivity
with organic matter which converts them readily into
sodium chloride and calcium chloride. The human health
concerns relative to these inorganic ions are veil
understood and the use of these chemicals will not add
any additional calcium or sodium chloride burden for the
users.
The Agency is aware of the potential risk concerning the
formation of trihalomethanes, especially in drinking
water, from the use of sodium and calcium hypochlorite.
The Office of Drinking Water has addressed this risk by
setting a maximum contaminant level of 100 ppb for
trihalomethanes in drinking water. The Agency believes
that this level is commensurate with an acceptable risk
determination and limits the dietary exposure to
hypochlorites.
2« Dietary Exposure
a. Residue Data
The February 1986 Guidance Document listed no residue
chemistry data requirements for calcium or sodium
hypochlorite. Under 40 CFR 180.1054, calcium
hypochlorite is exempted from the requirement of a
tolerance when used preharvest or postharvest in solution
on all raw agricultural commodities, sodium hypochlorite
is considered to be Generally Recognized As Safe (GRAS)
under 40 CFR 180.2. (The Agency intends to propose a
specific exemption from the requirement of a tolerance
for sodium hypochlorite on all raw agricultural
commodities (RAC) under FFDCA sec. 408, and to delete the
GRAS listing from 180.2). Based on this, no residue
chemistry data are required for sodium or calcium
hypochlorite under current scientific standards. There
are no minor use concerns at present and there are no
codex, Mexican, or Canadian MRL considerations with
respect to sodium or calcium hypochlorite.
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b. Tolerance Reassessment
Sodium hypochlorite is considered to be GRAS under
40 CFR 180.2. The Agency intends to propose a
specific exemption from the requirement of a
tolerance for sodium hypochlorite on all raw
agricultural commodities (RAG) under FFDCA sec.
408, and to delete the GRAS listing from 180.2. An
incidental food additive regulation allowing the
use of sodiun hypochlorite as a terminal sanitizing
rinse on food processing equipment has been
established (21 CFR 178.1010) . Also, a food
additive regulation permitting the use of sodium
hypochlorite in washing or assisting in lye peeling
of fruits and vegetables has been established (21
CFR 173.315) by the Food and Drug Administration
(FDA). No new tolerances are necessary for the
existing uses of sodium hypochlorite.
Calcium hypochlorite is exempted from the
requirement of a tolerance under FFDCA sec. 408 (40
CFR 180.1054) when used preharvest or postharvest
in solution on all raw agricultural commodities.
The Agency has reevaluated this exemption and has
determined that it is still appropriate. Also, an
incidental food additive regulation allowing the
use of calcium hypochlorite as a terminal
sanitizing rinse on food processing equipment has
been established (21 CFR 178.1010).
It should be noted, however, that even though
sodium hypochlorite is considered to be GRAS and
calcium hypochlorite is exempt under Section 408 of
the FFDCA from the requirements of a tolerance for
use preharvest or postharvest on raw agricultural
commodities, these exemptions do not cover the uses
of sodium and calcium hypochlorite as food
additives in or on processed foods, which is
regulated under Section 409 of the FFDCA. The 1986
Standard required registrants to obtain a food
additive regulation for calcium hypochlorite in
sugar syrup and raw sugar (the processed commodity)
from FDA within 12 months from the date of issuance
of the Standard or delete the claim from the
appropriate product labeling. This food additive
regulation has not been established for either
sodium or calcium hypochlorite.
3. Occupational and Residential pxposurg
The 1986 Guidance Document for sodium and calcium
hypochlorite did not require reentry or
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mixer/loader/applicator exposure monitoring data. Sodium
and calcium hypochlorite are chlorinated inorganic
disinfectants registered for use in laundry, swimming
pools, ponds, drinking water, and other water and
wastewater systems, on food and non-food contact
surfaces, and on various crops, including mushrooms
(pins), potatoes, and sweet potatoes (postharvest).
Based on current registered use patterns, the Agency has
determined that the potential for post application
exposure for sodium and calcium hypochlorite is minimal
and therefore does not meet the Agency's exposure
criteria for requirement of reentry or
mixer/loader/applicator exposure monitoring data.
Therefore, these data are not required to support the
reregistration of sodium and calcium hypochlorite.
Based on the acute toxicity of sodium and calcium
hypochlorite, label requirements for the use of
protective clothing, including safety glasses or goggles
and chemical-resistant gloves while handling end-use
products containing sodium or calcium hypochlorite as the
active ingredient remain as required in the 1986 Guidance
Document. Reentry levels for application of sodium or
calcium hypochlorite to swimming pools (3.0 ppm} and
spas/hot tubs (5.0 ppm) and reentry intervals for
spray/fog application to food and non-food contact
surfaces (2 hour reentry interval following application)
also remain as required in the 1986 Guidance Document.
4. Risk Assessment
Based on the above considerations concerning the
toxicology profile and exposure scenarios for calcium and
sodium hyj>ochlorites it can be concluded that risks from
chronic and subchronic exposure to low levels of calcium
and sodium hypochlorites are minimal and without
consequence on human health. Risks for acute exposure to
high concentrations of calcium and sodium hypochlorites
may be significant with respect to eye and skin injury
but the Agency believes that these risks are sufficiently
mitigated by adequate precautionary labeling requiring
protection of eyes and skin while using calcium and
sodium hypochlorites.
ENVIRONMENTAL ASSESSMENT
The environmental fate and ecological effects data
requirements have been satisfied for all currently
registered uses eligible for reregistration. Zn the 1986
Registration Standard, it was determined that the
available fish and wildlife data were sufficient to
characterize the acute toxicity risks to non-target
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organisms and that no subchronic or chronic data were
required. Many of these data requirements were fulfilled
by the EPA Publication Ambient Water Quality Criteria for
Chlorin^ by J. Tobler, et air U.S. EPA, June 1981. Thus,
no further environmental fate or ecological effects data
were required.
The data cited in the Standard are discussed below.
Upon reevaluation, the available data support the
conclusion that the currently registered uses of sodium
and calcium hypochlorite will not result in unreasonable
adverse effects to the environment. As discussed in the
Standard, the currently accepted uses that result in
point source discharges of effluents containing sodium
and calcium hypochlorites will continue to be regulated
through issuance of National Pollutant Discharge
Elimination System (NPDES) permits. Such permits are
tailored to a specific site or point of discharge. The
Agency has determined that the discharge amounts
permitted by the NPDES permits, which are specific to
each site, will not pose significant adverse effects on
non-target organisms.
1. Ecological Effects Assessment
There are a number of scientifically sound data
considered adequate to characterize the toxicity of the
sodium and calcium hypochlorite salts. Results from the
avian acute oral studies (MRID 00007276, 00007403, and
00007496) indicate that the sodium and calcium salts are
low in toxicity to avian wildlife. The results from the
avian subacute dietary studies (MRID 00007275, 00007273,
00007404, and 00007405} indicate that the sodium salt is
practically non-toxic to upland game birds and waterfowl.
Results from the fish acute toxicity studies (MRID
00007400, 00007495, 00008190, 00008191, and 00007401)
indicate that the hypochlorite salts are highly toxic to
freshwater fish. The acceptable studies on the acute
toxicity to freshwater invertebrates (MRID 00007279,
00007402, 00007495, and 00013313) indicate that the
hypochlorite salts are very highly toxic to freshwater
invertebrates. Although these fish and aquatic
invertebrate studies demonstrate high toxicity to sodium
and calcium hypochlorite, the Agency believes that these
risks are sufficiently mitigated by adequate
precautionary labeling and the NDPES permit requirement.
The results of these studies are listed below:
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Species
Value
Toxicitv
Upland Game acute
Birds oral
LD50 3474 mg/kg (Ca)
LD50 >2510 mg/kg (Na>
Practically
Non-toxic
Upland Game Subacute LCSO >5000 ppm (Na)
Birds and Dietary
Waterfowl
Practically
Non-toxic
Cold Water
Fish
acute LC50 0.132-1.35 ppm
toxicity (96-hr)
(hypochlorite salts)
Highly toxic
freshwater
fish
Warm Water
Fish
acute kC50 0.28-2.1 ppm
toxicity (96-hr)
(hypochlorite salts)
Highly toxic
freshwater
fish
Daphnia maana acute LC5Q 0.037-2.3 ppm Very highly
toxicity (48-hr) toxic to
(hypochlorite salts) freshwater
invertebrate
2.
Environmental Fate Assessment
The February 1986 Guidance Document listed no
environmental fate deficiencies for calcium or sodium
hypochlorite. The environmental fate data requirements
for the hypochlorite salts have been fulfilled by the
document Ambient Water Quality Criteria for Chlorine
(MRID 40911802), published by the Environmental
Protection Agency. No further environmental fate data
were required in the 1986 Guidance Document. After
reevaluating the environmental fate data base, the Agency
has determined that it will not require any additional
environmental fate data. In aqueous media, sodium
hypochlorite and calcium hypochlorite produce
hypochlorous acid, hypochlorite ions, and hydronium ions,
a reaction which is independent of the nature of the
counter cation (i.e., sodium or calcium). The amount of
hypochlorous acid, hypochlorita and hydronium ions
present in solution depends on the pH of the medium. The
data available indicate that the photolysis rate of
calcium hypochlorite in aqueous solution increases with
increasing light intensity. Calcium hypochlorite at 10
g/1 has a half-life of 10-12 months and 4 months under
diffused daylight and under diffused daylight with
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intermittent direct sunlight, respectively, Seawater has
a large capacity to consume hypochlorites. Sodium
hypochlorite is expected to show a similar behavior.
When sodium hypochlorite is added to seawater, residual
chlorine levels declined rapidly in the first hour. The
rapid initial decline was followed by a much slower and
continuous decline in residual chlorine levels. The
available data indicate that hypochlorites undergo
reaction with bromide ions in seawater to form
hypobromite. This reaction is rapid and appears to be
complete within 2.5 minutes. Although hypobromite is
acutely toxic to aquatic organisms, from a chronic
viewpoint it does not appear to be toxic because it is
highly volatile and will not persist in the aquatic
environment. (Halflife is less than 96 hrs in water).
The Agency believes that the risk of acute exposure to
aquatic organisms is sufficiently mitigated by adequate
precautionary labeling and the NDP1S permit requirement.
Although no exposure, bioaccumulation, or
volatility data are available to quantitatively assess
the potential for exposure of wildlife to the
hypochlorites, the use patterns indicate that most
exposure will occur in the aquatic environment, and that
significant amounts of hypochlorites in the terrestrial
environment will not occur.
The available data are considered sufficient to
assess the environmental fate of the hypochlorite salts
and the data support the conclusion that the-currently
registered uses of sodium and calcium hypochlorite will
not result in unreasonable adverse effects to the
environment.
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IV. REREGISTRATION DECISION FOR ACTIVE INGREDIENT
A. DETERMINATION OF ELIGIBILITY
Section 4 (g) (2) (A) of FIFRA calls for the Agency to
determine, after submission o£ relevant data concerning an
active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has
previously identified and required the submission of the
generic (i.e., active ingredient specific) data required to
support reregistration of products containing sodium or
calcium hypochlorite as an active ingredient. The Agency has
completed its review of these generic data, and has determined
that the data are sufficient to support reregistration of
products containing sodium or calcium hypochlorite. Appendix
B identifies the generic data requirements that the Agency
reviewed as part of its determination of reregistration
eligibility of sodium and calcium hypochlorites, and lists the
submitted studies that the Agency found acceptable.
The data identified in Appendix B are sufficient to allow
the Agency to conduct a reasonable risk assessment for the
registered uses of sodium and calcium hypochlorite. The data
available to the Agency support the conclusion that the
registered uses of sodium and calcium hypochlorite will not
result in unreasonable adverse effects to the environment.
The Agency has determined that all products containing sodium
and calcium hypochlorites as the active ingredient are
eligible for reregistration except the uses on sugar syrup and
raw sugar (the processed commodity). The uses on sugar syrup
and raw sugar (the processed commodity) for sodium and calcium
hypochlorite are not eligible for reregistration without the
acquiring of a food additive regulation from FDA. (See
Section III(B)(2) (b) of this document). Since this regulation
was not obtained, these uses must be deleted from the
appropriate product labeling within 8 months of the date of
this document or be subject to enforcement action. The
reregistration of particular products is addressed in section
V of this document ("Product Registration").
The Agency made its reregistration eligibility
determination based upon the target data base required for
reregistration, the current guidelines for conducting
acceptable studies to generate such data, and the data
identified in Appendix B. Although the Agency has found that
products containing sodium and calcium hypochlorite ar«
eligible for reregistration, it should be understood that the
Agency may take appropriate regfulatory action, and/or require
the submission of additional data to support reregistration of
products containing sodium or calcium hypochlorite, if n«w
information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for
12
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-
generating such data) change.
B. ADDITIONAL GENERIC DATA REQUIREMENTS
The generic data base supporting the reregistration of
products containing sodium or calcium hypochlorites has been
reviewed and determined to be complete for reregistration. No
further generic data are required.
C, LABELING REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
CONTAINING SODIUM OR CALCIUM HYPOCHLORITES
1. The labels and labeling of all products must comply with
EPA's current regulations and requirements. Follow the
instructions in the Product Reregistration Handbook with
respect to labels and labeling. Any product label which
allows both manufacturing and end use must be amended to
specify only manufacturing or end use. In this
situation, if a registrant amends his/her label, to
specify manufacturing use only and wishes to retain end
use registration, he/she must apply for a separate end-
use product registration.
2. Based on the reviews of the generic data, the following
additional label statements are required:
a. In the directions for use, the following statement
must appear:
"Formulators using this product are responsible for
obtaining EPA registration of their formulated
products.11
b. In the directions for use, the following statement
regarding acceptable use patterns must appear:
"For formulation into end-use products intended
only for (list acceptable sites!.
c. The following Environmental Hazard statement is
required for any use that results in discharge into
the aquatic environment:
"This pesticide is toxic to fish and aquatic
organisms. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries,
oceans or public waters unless this product is
specifically identified and addressed in an NPOES
permit. Do not discharge effluent containing this
product to sewer systems without previously
13
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notifying the sewage treatment plant authority.
For guidance contact your State Water Board or
Regional Office of the EPA."
d. Because of the corrosive nature of sodium and
calcium hypochlorite and the potential for severe
eye and skin damage from accidental spills of these
chemicals, EPA is requiring that the statement of
Practical Treatment appear on the front panel of
all products which have been assigned toxicity
category Z for eye and/or skin effects.
e. The "If Swallowed" statement in the statement of
practical treatment must read as follows;
"IF SWALLOWED, drink large amounts of water. DO
NOT induce vomiting. Call a physician or poison
control center immediately."
V. PRODUCT RER1GISTRATION
A. DETERMINATION OF ELIGIBILITY
Based on the reviews of the generic data for the
active ingredients, sodium and calcium hypochlorites, the
products containing this active ingredient are eligible
for reregistration. Section 4(g)(2)(b) of FIFRA calls
for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of
eligibility has been made. The Agency will review these
data when they have been submitted and/or cited and
determine whether to reregister individual products.
For products that meet the criteria of the 1986
standard and were registered or reregistered under option
I (the "general Registration" procedure) (the registrant
relied on available data to support registration of
Toxicity Category I products and adopted the generic
labeling provided by the Agency), or option II (the
registrant either relied on available data to support
registration of Toxicity Category I products and
submitted their own specific labeling or developed data
independently to support registration of toxicity
category I products and submitted their own specific
labeling) , the Agency is requiring that labels
reflecting the changes stated within this document and
C8F* be submitted within 8 months of receipt of this
document. Upon receipt and approval of revised labels
and CSFs, these products, will be reregistered under
section 4(g).
14
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For products that do not meet the criteria of the
1986 Standard, (i.e. products whose concentrations of the
a.i. fall outside the range specified by the standard for
sodium hypochlorite 5.25% - 12.5% and for calcium
hypochlorite 65% - 70%; products with intentionally added
inert ingredients other than water; and products which
are mixtures with other active ingredients), the Agency
is requiring that the registrants either submit product
specific data or cite previously submitted data to
support their registrations and submit revised labeling
and cpss within 8 months of receipt of this document
before the products will be considered for
reregistration. After reviewing these data and the
revised labels, the Agency will determine whether to
reregister each product based on whether or not it meets
the requirements in section 3(c)(5) of the Federal
Insecticide, Fungicide, and Rodenticide Act. Those
products which contain other active ingredients will be
eligible for reregistration only when the other active
ingredients are determined to be eligible Cor
reregistration.
While the Agency will continue to register sodium
and calcium hypochlorite products as discussed above
under the provisions of the February 1986 Registration
Standard, EPA does not plan to issue further amendments
to that document. Consequently, EPA will no longer
consider amendments to general registration (Series
20,000) labeling for the purpose of adding uses or
language inconsistent with that Standard. Applicants who
wish approval for such amendments must apply for a new
product registration and will be assigned a conventional
registration number upon acceptance.
B. PRODUCT SPECIFIC DATA REQUIREMENTS
The product-specific data requirements are stated in
the attached appendices. For-those products that were not
subject to the 1986 Registration Standard (which include
those products whose concentrations of the a.i. fall
outside til* range covered by the standard for sodium
hypochlorite 5.25% - 12.5% and for calcium hypochlorite
651 - 70%; those products with additional inert
ingredient* other than water, and those products which
are mixtures with other active ingredients) the
registrant is responsible for either submitting data or
citing previous data he submitted to support his
registrations. Registrants of products which were
subject to the 1986 registration standard do not need to
submit or cite data since they did so already in
complying with that standard.
15
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i
The Agency has decided to continue its current
policy of waiving the product-by-product efficacy data
requirement normally levied on sanitizers and
disinfectants for sodium and calcium hypochlorite
formulations. The Agency has concluded that the
published literature data can reasonably be extrapolated
to the full range of these products.
C. LABELING REQUIREMENTS FOR END-USE PRODUCTS
CONTAINING SODIUM OR CALCIUM HYPOCHLORITE
1. The labels and labeling of all products must comply
with EPA's current regulations and requirements.
Follow the instructions in the Product
Reregistration Handbook with respect to labels and
labeling. Any product label which allows both
manufacturing and end use must be amended to
specify only manufacturing o,g end use. In this
situation, if a registrant amends his label to
specify end-use registration and wishes to retain
manufacturing use registration, he must apply for a
separate manufacturing use product registration.
2. Because of the corrosive nature of sodium and
calcium hypochlorite and the potential for severe
eye and skin damage from accidental spills of these
chemicals, EPA is requiring that the Statement of
Practical Treatment appear on the front panel of
all products which have been assigned toxicity
category I for «y» and/or akin *ffacts.
3. The "If Swallowed" statement must read as follows:'
"IP SWALLOWED, drink large amounts of water. DO
NOT induce vomiting. Call a physician or poison
control center immediately."
4. Tha 1986 Registration Standard stated that
applicants whose product labeling contains use in
sugar syrup and raw sugar must obtain a food
additive regulation to support these uses as
required by the provisions of the Federal Food Drug
and Cosmetic Act (21 CFR 173 Subpart D -Specific
Usage Additives). Since this regulation was not
obtained, registrants whose product labeling
contains the food additive claim for calcium
hypochlorite in sugar syrup and raw sugar (the
processed commodity) must delete this claim from
the appropriate calcium, as well as sodium
hypochlorite labeling within 8 months of the date
16
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1
of this document or be subject to enforcement
action.
5. The following Environmental Hazard statement is
required for any use that results in discharge into
the aquatic environment:
"This pesticide is toxic to fish and aquatic
organisms. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries,
oceans or public waters unless this product is
specifically identified and addressed in an NPDES
permit. Do not discharge effluent containing this
product to sewer systems without previously
notifying the sewage treatment plant authority.
For guidance contact your State Water Board or
Regional Office of the EPA."
17
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i
APPENDIX A
DETAILED SPECIFIC USE SITES
FOR
SODIUM AND CALCIUM HYPOCHLORITES
-------
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CALCIUM HY1OCHLORITE (014701)
SITES (APPLICATION TYP1-IF GIVENJ
USE GROUPS
PECANS (WATER TREATMENT)
PECANS (POSTHARVEST APP TO NON-STRD COMM.)
TOMATOES (SEED TREATMENT)
POTATOES (POSTHRT. APP. TO NON-STRD COMM.)
SWEET POTATOES (POSTHRT. TO NON-STRD. CM.)
MUSHROOMS (FOLIAR OR SOIL TRT.)
PIMENTOS (SEED TREATMENT)
VEGETABLES OR POST HRT. APP TO VEG. CROPS
FRUIT OR POST HRT. APP TO FRUIT CROPS
SEEDS- AGRICULTURAL
it
SEEDS-ORNAMENTAL
SUGAR-RAW
FISH-EXCLUDING SHELLFISH
POULTRY HOUSE TRT.
POULTRY FEEDING AND WATERING EQPMT
POULTRY TRANSPORTATION VEHICLES
ANIMAL EQUIPMENT
ANIMAL EQUIPMENT
ANIMAL EQUIPMENT
ANIMAL FEEDING/WATERING EQUIPMENT
ANIMAL FEEDING/WATERING EQUIPMENT
ANIMAL FEEDING/WATERING EQUIPMENT
ANIMAL LIVING QTRS AND TRANS VEHICLES
COMMERCIAL IGG TRT
DAIRY UTIL. AND MILKING EQUIPMENT
DAIRIES
FARM PREMISES (UNSPECIFIED)
FARM OR AGRICULTURAL STRUCTURES AND EQUIP,
FOOD MARKET/STRG/DISTRIBUTION FACILITIES
BEEKEEPING EQUIPMENT
FISH HANDLING EQUIP.
FISH POND EQUIPMENT
HOUSEHOLD PREMISES
SIDING
FISH HATCHERIES AND PONDS
LOBSTER AND OYSTER PONDS
FISH/FOOD PROCESSING WATER
FRUIT/VEGETABLE PROCESSING/WASH WATER
CANNERY COOLING CANAL WATER
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FEED CROP
TERRES. NON-FOOD CROP
INDOOR FOOD
AQUATIC FOOD CROP
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR RESIDENTIAL
INDOOR NON-FOOD
INDOOR FOOD
INDOOR RESIDENTIAL
INDOOR FOOD
INDOOR NON-FOOD
INDOOR RESIDENTIAL
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
AQUATIC FOOD CROP
AQUATIC FOOD CROP
INDOOR RESIDENTIAL
OUTDOOR RESIDENTIAL
AQUATIC FOOD CROP
AQUATIC FOOD CROP
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
-------
PULP AND PAPER MILL SYSTEMS
POULTRY DRINKING WATER
SWIMMING POOL WATER
SPAS AND HOT TUBS-OUTDOOR
ANIMAL/HUMAN DRINKING WATER AND SURFACES
AIR WASHER WATER
COOLING TOWER WATER
EVAPORATIVE CONDENSER WATER
PONDS-ORNAMENTAL AND FISH
SEWAGE SYSTEMS/WASTE WATER\SEPTIC TANKS
HEAT EXCHANGER/INDUSTRIAL PROCESSING H2O
WHIRLPOOL BATH WATER
RESERVOIRS
BOATS AND SHIPS
ARTIFICAL SAND BEACHES
RECREATIONAL VEHICLES
FOOD PROCESSING EQUIP.
FOOD PROCESSING PREMISES
BAKERY PROCESSING EQUIP.
BAKERY PROCESSING PREMISES
BOTTLING PROCESSING EQUIP.
BOTTLING PREMISES
BREWERY PROCESSING EQUIP.
BREWERY PREMISES
CANNERY PROCESSING EQUIP.
CANNERY PROCESSING PREMISES
ICE CREAM PROCESSING EQUIP.
BUTTER PROCESSING EQUIP.
MILK PROCESSING EQUIP.
MILK PROCESSING PREMISES
CHEESE AGING ROOMS
CHEESE PROCESSING PREMISES
MEAT PROCESSING EQUIP.
MEAT PROCESSING PREMISES
POULTRY PROCESSING EQUIP.
POULTRY PROCESSING PREMISES
WINERY EQUIP.
WINERY PREMISES
EGG BREAKING EQUIP.
BEVERAGE PROCESSING EQUIP.
BEVERAGE PROCESSING PREMISES
FISH PROCESSING EQUIP.
AQUATIC NON-FOOD INDUS.
INDOOR FOOD
AQUATIC NON-FOOD RESID.
AQUATIC NON-FOOD RESID.
INDOOR FOOD
AQUATIC NON-FOOD INDUS.
AQUATIC NON-FOOD INDUS.
AQUATIC NON-FOOD INDUS.
AQUATIC NON-FOOD RESID.
AQUATIC NON-FOOD INDUS.
AQUATIC NON-FOOD INDUS.
AQUATIC NON-FOOD RESID.
AQUATIC FOOD CROP
AQUATIC NON-FOOD OUTDOOR
AQUATIC NON-FOOD RES
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NOW-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
EATING ESTAB./EQUIP./UTENSILS/CONTACT SURF INDOOR FOOD
EATING ESTAB. NON-FOOD CONTACT SURFACES
CGMMIRCIAL/INDUSTRIAL/STORAGE PREMISES
GROUTS/AWNINGS
LAUNDRY-HOUSEHOLD
LAUNDRY-COMMERCIAL
DOMESTIC DWELLINGS
BATHROOM PREMISES/URINALS/TOILETS
INDUSTRIAL PROCESS PLANT PREMISES
INSTITUTIONAL PREMISES
INDOOR NON-FOOD
INDOOR NON-FOOD
RESIDENTIAL OUTDOOR
INDOOR RESIDENTIAL
INDOOR NON-FOOD
INDOOR RESIDENTIAL
INDOOR RESIDENTIAL
INDOOR NON-FOOD
INDOOR NON-FOOD
20
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i
ENVIRONMENTAL INANIMATE HARD SURFACES
it
HEMODIALYSIS MACHINES
HOSPITAL PREMISES
FURNITURE-OUTDOOR
ROOFS
SHOWER CURTAIN SURFACES
TILE-CERAMIC/TILE SURFACES
SURFACES-PAINTED OR UNPAINTED/FINSD WOOD
it
HARD NONPOROUS SURFACE
ASPHALT ROOFS/ROOFS-WOOD
AUTO TOPS
WALL SUHFACES/WALL-BRICK
ti
ASBESTOS ROOFS/SHINGLES
INDOOR MEDICAL
INDOOR RESIDENTIAL
INDOOR MEDICAL
INDOOR MEDICAL
RESIDENTIAL OUTDOOR
RESIDENTIAL OUTDOOR
INDOOR NON-FOOD
INDOOR NON-FOOD
INDOOR NON-FOOD
RESIDENTIAL OUTDOOR
INDOOR NON-FOOD
INDOOR MEDICAL
INDOOR FOOD
RESIDENTIAL OUTDOOR
RESIDENTIAL OUTDOOR
INDOOR NON-FOOD
RESIDENTIAL OUTDOOR
RESIDENTIAL OUTDOOR
USE GROUP SUMMARY: TERRESTRIAL FOOD CROP, TERRESTRIAL FEED CROP,
TERRESTRIAL NON-FOOD CROP, AQUATIC FOOD CROP, AQUATIC NON-FOOD
OUTDOOR, AQUATIC NON-FOOD INDUSTRIAL, AQUATIC NON-FOOD RESIDENTIAL,
RESIDENTIAL OUTDOOR, INDOOR FOOD, INDOOR MOM-FOOD, INDOOR MEDICAL,
INDOOR RESIDENTIAL.
21
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SODIUM HYPOCHLORITE
(14703)
SIT1S {APPLICATION TYPES-IF GIVEN)
USE GROUPS
CITRUS-INC. GRAPEFRUIT, ORANGES,
11
APPLES
ii
PEARS
QUINCES
STONE FRUITS
CHERRIES
NECTARINES
PEACHES
PLUMS/PRUNES
MELONS
CUCUMBERS
PEPPERS
PIMENTOS
PECANS (POSTHARVEST APP TO NON-STRD
TOMATOES (POSTHARVEST APP./SEED TRT)
CROP "
BRUSSEL SPROUTS
CABBAGE
CAULIFLOWER
ARTICHOKES
LETTUCE
CARROTS
POTATOES
RADISHES
SWEET POTATOES
ASPARAGUS
MUSHROOMS
MUSHROOMS
ONIONS
CELERY
PEPPERS (SEED TRT)
ROSES-CUTTINGS
SUGAR-RAW
LIVESTOCK VmS/SThLLS/FEEDING/WATER EQUIP.
FISH (MEAT)
POULTRY PREMISES/FEEDING/WATERING/TRANSPOR
POULTRY (ANIMAL TREATMENT)
ANIMAL TRANSPORTATION VEHICLES/EQUIPMENT
ANIMAL TRANSPORTATION VEHICLES/EQUIPMENT
LEMONS TERRESTRIAL FOOD CROP
TERRESTRIAL FEED CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FEED CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
COMM) TERRESTRIAL FOOD
TERRESTRIAL FOOD CROP
TERRESTRIAL FEED CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
GREENHOUSE FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL FOOD CROP
TERRESTRIAL NON-FOOD C.
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR NON-FOOD
WOOD SIDING (NONSOIL CONTACT NONFUM. TREAT) OUTDOOR RESIDENTIAL
SUGARCANE JUICE
BUTTER PROCESSING EQUIPMENT
SEWAGE EFFLUENT WATER
INDOOR FOOD
INDOOR FOOD
AQUATIC NONFOOD INDUS
22
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ANIMAL CAGES/LIVING QTRS/FEEDING/WATERING
ti
PET SLEEPING QUARTERS
COMMERCIAL EGG TRT
DAIRY PREMISES/EQUIP./STORAGE/UTENSILS
FARM/AGRICULTURAL EQUIP./BARN
BEEKEEPING EQUIP.
FISH HANDLING EQUIP.
FISH POND EQUIP.
BATH MATS
HOUSEHOLD CONTENTS/PREMISES
SICKROOM EQUIP./PREMISES/UTENSILS
SIDING/WOOD SIDING
FISH HATCHERIES/PONDS
MARINE LOBSTER/OYSTER PONDS
BOTTLE WASHER WATER
BREWERY PASTEURIZER WATER
EGG/FOOD PROCESSING WATER
INDOOR NON-FOOD
INDOOR FOOD
INDOOR RESIDENTIAL
INDOOR NON-FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
AQUATIC FOOD CROP
AQUATIC FOOD CROP
INDOOR RESIDENTIAL
INDOOR RESIDENTIAL
INDOOR MEDICAL
RESIDENTIAL OUTDOOR
AQUATIC FOOD CROP
AQUATIC FOOD CROP
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
MEAT/POULTRY/FRUIT/VEGETABLE PROCESSING H2O INDOOR FOOD
INDUSTRIAL PULP AND PAPER MILL SYSTEMS
SWIMMING POOL WATER
HOT TUBS/SPAS/ARTIFICIAL SAND BEACHES
DRAINS/DRAIN PIPES
HUMAN DRINKING WATER
ANIMAL DRINKING WAT1R
COOLING TOWER/EVAPORATIVE CONDENSER WATER
IRRIGATION SUPPLY SYSTEMS
PONDS-ORNAMENTAL FISH/FOUNTAINS
SEWAGE SYSTEMS/WASTE WATER SYSTEMS
DISHWASHING MACHINE WATER
INDUSTRIAL PROCESSING WATER
IMMERSION ULTRASONIC TANK WATER
WHIRLPOOL BATH WATER
PONDS
RESERVOIRS
BOAT BOTTOMS/SHIP HULLS
TRUCKS •
FOOD PROCESSING EQUIP.
FOOD PROCESSING PLANT PREMISES
BAKERY PROCESSING EQUIP.
BAKERY PROCESSING PREMISES
BOTTLES/BOTTLING PLANT SURFACES
BREWERY PROCESS PLANT EQUIP.
BREWERY PREMISES
CANNERY PROCESS PIANT PREMISES/EQUIP.
AQUATIC NON-FOOD
AQUATIC NON-FOOD RES.
AQUATIC NON-FOOD RES.
AQUATIC NON-FOOD RES,
INDOOR FOOD
INDOOR NON-FOOD
AQUATIC NON-FOOD INDUS.
AQUATIC FOOD CROP
AQUATIC NON-FOOD RES.
AQUATIC NON-FOOD INDUS.
AQUATIC NON-FOOD RES.
AQUATIC NON-FOOD INDUS.
AQUATIC NON-FOOD INDUS.
AQUATIC NON-FOOD RES.
AQUATIC NON-FOOD OUTD.
AQUATIC FOOD CROP
AQUATIC NON-FOOD INDUS.
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
MILK TRANSPORT. VEHICLES/PROCESS PLANT/EQUIP.INDOOR FOOD
CHEESE PROCESSING EQUIP.
FRUIT PROCESSING EQUIP.
VEGETABLE PROCESSING PLANTS/EQUIP.
MEAT PACKING EQUIP./PROCESS PLANT PREMISES
POULTRY PROCESSING EQUIP./PLANT PREMISES
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
23
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WINERY PROCESSING EQUIP./PROCESS PLANT
EGG PROCESSING PLANT/EQUIPMENT
BEVERAGE PROCESSING EQUIPMENT/CASES/PLANT
FISH PROCESSING PLANT PREMISE
EATING ESTA8LISHMENT/UTENSILS/FD-CONTACT S,
FOOD HANDLING SURFACES/PREMISES/UTEN./EQUIP
FOOD MARKETS
AMBULANCES
HOSPITAL INSTRUMENTS/STAINLESS STEEL INTRUM
HOSPITAL PREMISES/LABORATORIES
VETERINARY HOSPITAL PREMISES/MATERIALS
HEMODIALYSIS MACHINES/HOSPITAL MATERIALS
BEDPANS
FLOOR MATS/FLOORS
INDUSTRIAL PREMISES/EQUIP.
LOCKER/SHOWER ROOM PREMISES
STORES
it
BEDDING-HUMAN/SHQWIR CURTAINS
LAUNDRY/EQUIP.
DIAPERS/DIAPER PAILS
ii
BATHROOM PREMISES/SHOWER STALLS/TOILETS
URINALS
CUSPIDORS
GARBAGE STORAGE PREMISES/CONTAINERS/CANS
ENVIRONMENTAL INANIMATE HARD SURFACES
ii
AIR TREATMENT-FOOD PROCESS PLANT
SURFACES
BATHHOUSE SURFACES/SHOWER SURFACES
HARD NONPOROUS SURFACES/HD POROUS SURFACES
ii
ii
ROOFS (ASfHALT AND WOOD)
WOOD SURFACES-SEASONED/UNPAINTED
FABRIC SURFACES
HUMAN CLOTHING
LAUNDRY (HOSPITAL)
LAUNDRY (COIN-OPERATED
LAUNDRY (HOUSEHOLD)
FUNITOSB (OUTDOOR)
STOVE SURFACES
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
INDOOR FOOD
.INDOOR FOOD
INDOOR FOOD
INDOOR MEDICAL
INDOOR MEDICAL
INDOOR MEDICAL
INDOOR MEDICAL
INDOOR MEDICAL
INDOOR MEDICAL
INDOOR RESIDENTIAL
INDOOR NON-FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR NON-FOOD
INDOOR RESIDENTIAL
INDOOR RESIDENTIAL
INDOOR RESIDENTIAL
INDOOR NON-FOOD
INDOOR RESIDENTIAL
INDOOR RESIDENTIAL
INDOOR MEDICAL
INDOOR RESIDENTIAL
INDOOR MEDICAL
INDOOR RESIDENTIAL
INDOOR FOOD
INDOOR NON-FOOD
INDOOR FOOD
INDOOR MEDICAL
INDOOR RESIDENTIAL
INDOOR NON-FOOD
INDOOR FOOD
INDOOR MEDICAL
RESIDENTIAL OUTDOOR
RESIDENTIAL OUTDOOR
INDOOR RESIDENTIAL
INDOOR RESIDENTIAL
INDOOR MEDICAL
INDOOR RESIDENTIAL
INDOOR RESIDENTIAL
RESIDENTIAL OUTDOOR
INDOOR RESIDENTIAL
081 GROUP SUMMARY: TERRESTRIAL FOOD CROP, TERRESTRIAL FEED
CROP, TERRESTRIAL NON-FOOD CROP, AQUATIC FOOD CROP, AQUATIC NON-
FOOD OUTDOOR, AQUATIC MOM-FOOD INDUSTRIAL, AQUATIC MOM-FOOD
RESIDENTIAL, RESIDENTIAL OUTDOOR, INDOOR FOOD, INDOOR MOM-FOOD,
INDOOR MEDICAL, INDOOR RE8IDEMTIAL.
24
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APPENDIX B
G«n«ric Bat* R«quir«m«nts for R«r«gistration
of sodiua OK Calcium Hypochlorit* and Data Citations
Supporting R«r«gistration
25
-------
-------
GUIDE TQ APPENDIX B
Appendix B contains listings of data requirements which
support the reregistration for the pesticide covered by this
Reregistration Eligibility Document.
Appendix B contains generic data requirements that apply to
the pesticide in all products, including data requirements for
which a "typical formulation" is the test substance.
The data table are generally organized according to the
following format:
1. Data Requjrrement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158. The
reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which are
available from the National Technical Information Service, 5285
Port Royal Road, Springfield, VA 22161.
2. Use Pattern (Column 2), This column indicates the use
patterns to which the data requirement applies. The following
letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
I Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
Any other designations will b« defined in a footnote to the
table.
3. lift! t
-------
APPENDIX B
DATA REQUIREMENTS FOR REREOISTRATION OF SODIUM HYPOCHLORITE
AMD DATA CITATIONS SUPPORTING REREOIBTRATION
GUIDELINE TITLJS OF
CITATION STUDY
product
61-1
*61-2a
*61-2b
62-1
chsaistiTY
Product Identity
Begin. Mat. and MFC Process
Discussion of Impurities
Preliminary Analysis
USB
PATTERNS
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
BIBLIOGRAPHIC
CITATION
00007588
00007588, 00007226, 00007269,
00025213
00007226, 00007588
00007227, 00007271, 00007588,
63-2 Color
63-3 Physical State
63-4 Odor
63-7 Density
63-12 pH
63-13 Stability
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
05011175
00007226
00007226
00007226
00007226
00007226
00007226
* These guideline numbers were previously 61-2 and 61-3, respectively.
27
-------
APPENDIX B
OBMERIC DATA REQUIREMENTS FOR REREGISTRATION OF SODIUM HYPOCHLORITE
AMD DATA CITATIONS SUPPORTING REREQISTRATION
QUIDBLINB
CITATION
TITLE OF
•TOOT
081
PATTERNS
BIBLIOGRAPHIC
CITATION
Ecological Effects!
71-la Acute avian oral - Quail
71-2a Acute avian dietary - Quail
71-2b Acute avian dietary - Duck
72-la Fish tox - Bluegill
72-ic Fish tox - Rainbow trout
72-2a Invertebrate tox
72-3a Estu/Mari Tox Fish
72-3b Estu/Mari Tox Mollusk
72-3c Estu/Mari Tox Shrinp
72-4a Early Life Stage Fish
72-4b Life cycle invertebrate
72-5 Life Cycle Fish
72-7 Field Testing - Aquatic Org
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEK
ABCDEFK
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFK
ABCDEFK
ABCDEFK
ABCDEFK
ABCDEFK
ABCDEFK
ABCDEFK
28
00007276, 00007403
00007275, 00007405
00007278, 00007404
00008190, 00007401, 40911802
00008191, 00007400, 40911802
00007279, 00007402, 000019313,
40911802
40911802
40911802
40911802
40911802
40911802
40911802
40911802
-------
APPENDIX B
QKN2AIC DATA RBQUIREMENTS FOB REREGI8TRATION OF SODIUM HYPOCHLORITE
AMD DATA CITATIONS SUPPORTING REREGI8TRATION
GUIDELINE
CITATION
TITLB OF
iTODY
081
PATTERNS
BIBLIOGRAPHIC
CITATION
Toxicology
81-1 Acute oral tox - rat
81-2
81-4
81-5
Acute dermal tox - rabbit
ABCDEFGKLMNO
ABCDEFGKLMNO
Primary eye irritation - rabbit ABCDEFGKlMNO
Priaary dermal irritation - rabbit ABCDEFGKOINO
00007540, 00020072, 00007397,
00007285, 00007274, 00007399,
00007374, 00007369
00007374, 00007369,00007285,
00007277, 00007398, 00020072,
00007540
00007374, 00007369, 00007274,
00008204, 00008206, 00007221,
00020072, 00007540
00007374, 00007369, 00007274,
00008203, 00008205, 00007221,
00020072, 00007540
29
-------
APPENDIX B
OBMB&IC DATA REQUIREMENTS FOB REREGI8TRATION OF SODIUM HYPOCHLORITE
AMD DATA CITATIONS SUPPORTING REREQI8TRATION
GUIDELINE
CITATION
TITLE Of
STUDY
USE
PATTERNS
BIBLIOGRAPHIC
CITATION
EHv i r onaent a1
161-1
161-2
162-3
162-4
164-2
165-3
Hydrolysis
Photodegradation - water
Anaerobic aquatic metab
Aerobic aquatic jnetab
Aquatic field dissipation
Accuaulation-irrig crop
ABCDEFGK
ABCDEFGK
ABCDEFG
DEFG
D1FG
DBF
40911802
05011199
40911802
40911802, 05021388
40911802
40911802
30
-------
APPENDIX B
OEMWUC DATA REQUIREMENTS FOR REREQIBTRATION OF CALCIUM HYPOCHLORITE
AMD DATA CITATIOMB SUPPORTING REREGI8TRATION
GUIDELINE
CITATION
TITLB OF
BTODY
USB
PATTERNS
BIBLIOGRAPHIC
CITATION
ABCDEFGKLMNQ
Product Cheaistry
61-1 Product Identity
*61-2a Begin. Mat. and MFC Process ABCDEFGKLMNO
*61-2b Discussion of Impurities ABCDEFGKLMNO
62-1 Preliminary Analysis
63-2 Color
63-3 Physical State
63-4 Odor
63-7 Density
63-12 pH
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
00007498
00007498, 05014892, 05012141
40929401
00007498, 05011175
00007498
00007498, 05009652
00007498
40929401
40929401
* These guideline numbers were previously 61-2 and 61-3, respectively.
-------
APPENDIX B
DATA REQUIREMENTS FOR REREOI8TRATION Of CALCIUM HYPOCHLORITE
AMD DATA CITATIONS SUPPORTING REREGI8TRATION
GUIDELINE
CITATION
TITLE 0V
•TODY
08E
PATTERNS
Ecological Effects;
71-la Acute avian oral - Quail
71-2a Acute avian dietary - Quail
71~2b Acute avian dietary - Duck
72-la Fish tox - Bluegill
72-lc Pish toK - Rainbow trout
72-2a Invertebrate tox
72-3a Estu/Mari Tox Fish
72-3b Estu/Mari Tox Mollusk
72-3c Estu/Mari Tox Shrimp
72-4a Early Life Stage Fish
72-4b Life Cycle Invertebrate
72-5 Life Cycle Fish
72-7 Field Testing - Aquatic Org
BIBLIOGRAPHIC
CITATION
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEK
ABCDEFK
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFK
ABCDEFK
ABCDEFK
ABCDEFK
ABCDEFK
ABCDEFK
ABCDEFK
32
00007496, 40230102
00007275, 00007405, 40230104
00007278, 00007404, 40230103
40911811, 40911802
00007495, 40911802
00007495, 40911802
40911802
40911802
40911802
40911802
40911802
40911802
40911802
-------
APPENDIX B
QBMBRXC OAT* REQUIREMENTS FOR REREGI8TRATION OF CALCIUM HYPOCHLORITE
AMD DATA CITATIONS SUPPORTIMG REREQIBTRATION
GUIDELINE
CITATIOM
TITLE OV
BTUDY
USB
PATTERNS
BIBLIOGRAPHIC
CITATIOM
Toxicology
81-1 Acute oral to* - rat
81-2 Acute dermal tox - rabbit
81-3 Acute Inhalation - rat
81-4 Primary eye irritation - rabbit
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
ABCDEFGKLMNO
81-5
Primary dermal irritation - rabbit ABCDEFGKLMNO
00007381, 00007580
00007381
00007560, 00007580
00007580, 00007381, 00007248, 00007249
00007580, 00007381, 00008202, 00007248
33
-------
APPENDIX B
QEN8RIC DATA REQUIREMENTS FOR REREGISTRATION OF CALCIUM HYPOCHLORITE
AND DATA CITATIONS SUPPORTING RBREGISTRATION
GUIDELINE
CITATION
Env i ronmen t a 1
161-1
161-2
162-3
162-4
164-2
165-3
TITLE OF
STUDY
Fat??
Hydrolysis
Photodegradation - water
Anaerobic aquatic metab
Aerobic aquatic metab
Aquatic field dissipation
Accuuiulation-irrig crop
USE
PATTERNS
ABCDEFGK
ABCDEFGK
ABCDEFG
DEFG
DEFG
DEF
BIBLIOGRAPHIC
CITATION
40911802
05011199
40911802
40911802,
40911802
40911802
05021388
34
-------
i
-------
I
APPENDIX C
SODIUM AND CALCIUM HYPOCHLORITE BIBLIOGRAPHY
Citations Considered to be Part of the
Data Base Supporting Reregistration
35
-------
-------
GUIDE TO APPENDIX C
1. 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.
2. UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study11. 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.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by Master Record Identifier," or MRID
number. This number is unique to the citation, and should be
used 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.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing standard
elements followed, in the case of material submitted to EPA,
by a description of the earliest known submission.
Bibliographic conventions used reflect the 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.
36
-------
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 data 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
th» 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 th* 27th, 123456-AA.
37
-------
I
OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
00007221 Sanders, B.O. (1972) Skin and Eye Irritation on 15 + 24 Germicidal
Cleaner. (Unpublished study received Aug 30, 1972 under 38-13;
prepared by Missouri Analytical Laboratories, Inc., submitted b;
Sinclair Manufacturing Co., Carson, Calif.; CDL:QOQQG4-A)
00007226 Wonder Chemical Corporation (1977) Product Chemistry Data, In-
cludes methods dated Jul 1977 entitled: Determination of avai-
lable chlorine in bleach solutions; method dated Jul 1977
entitled: Determination of excess Sodium hydroxide in bleach
solutions. (Unpublished study received Apr 25, 1978 under 193-
16? CDL:233827-A)
00007227 schultz, H. (1978) Quality Control Laboratory Reports Report
No. 9547-A. (Unpublished study received Apr 25, 1978 under 193-
16; prepared in cooperation with Dow Chemical Co., submitted by
Wonder Chemical Corp., Fairless Hills, Pa.; CDL:233827-1)
OOQ07248 Latven, A.R, (1976) Sentry (65% Available Chlorine): Toxicology
Report. (Unpublished study including letter dated May 13, 1976
froia A.R. Latven to George R, Dychdala, received May 14, 1976
under 335-188? prepared by Pharmacology Research, Inc., submit-
ted by Pennwalt Chemical Corp., Philadelphia, Pa.; CDL:227449-B
00007249 Latven, A.R. (1976) Sentry (30% Available Chlorine): Toxicology
Report. (Unpublished study including letter dated May 13, 1976
from A.R. Latven to George R. Dychdala, received May 14, 1976
under 335-188; prepared by Pharmacology Research, Inc., submit-
ted by Pennwalt Chemical Corp., Philadelphia, Pa,; CDL:227449-C
00007269 Hachik Bleach Company (1977) General Chemistry. Includes two
methods dated Jul 1977 entitled: Determination of excess Sodium
hydroxid in bleach solutions and Determination of available
chlorine in bleach solutions. (Unpublished study received May
15, 1978 under 7254-9,- CDLJ233981-A)
00007271 schultz, H. (1978) Quality Control Laboratory Report: Report No.
9547-DD. (Unpublished study received May 30, 1978 under 7254-9
prepared by Wonder Chemical Corp., submitted by Hachik Bleach
Co., Philadelphia, Pa.; CDL:235144-A)
38
-------
i
00007274 WARF Institute, Incorporated (1977) Report? Analysis for Acute
Toxicity, Primary Skin Irritation, Primary Eye Irritation: v.
Institute No. 7091487. (Unpublished study including letter
dated Nov 9, 1977 from L.M. Wise to Memo for file, received Nov
10, 1977 under 35317-1; submitted by Kuehne Chemical Co., Inc.,
Cranford, N.J. ; CDL:232206-A)
00007275 Beavers, J.B. (1978) Final Report; Eight-Day Dietary LC50—Bobwhite
Quail: Project No. 156-101. (Unpublished study received Apr 4,
1978 under 35317-1; prepared by Wildlife International, Ltd.,
submitted by Kuehne Chemical Co., Inc., Cranford, N.J.; CDL:
233388-A)
00007276 Beavers, J.B. (1978) Final Report; Acute oral LD50—Bobwhite Quail:
Project No. 156-103. (Unpublished study received Apr 4, 1978
under 35317-1; prepared by wildlife International, Ltd., submit-
ted by Kuehne Chemical Co., Inc., Cranford, N.J.; CDL:233388-B)
00007277 WARF Institute, Incorporated (1978) Report: Analysis for Acute Der-
mal Toxicity: WARF Institute No. 8021128. (Unpublished study
received Apr 28, 1978 under 35317-1; submitted by Kuehne Chemi-
cal Co., Inc., Cranford, N.J.,* CDL:233597-A)
00007278 Beavers, J.B. (1978) Final Report: Eight-Day Dietary LC50—Mallard
Duck: Project No. 156-102. (Unpublished study received Apr 28,
1978 under 35317-1; prepared by Wildlife International, Ltd.,
submitted by Kuehne Chemical Co., Inc., Cranford, N.J.* CDL:
233598-A)
00007279 Morrissey, A.E. (1978) The Acute Toxicity of Sodium hypochloriv
Solution to the Water Flea'Daphnia magna"(Straus): UCES
Proj. No. 11506-72-03. (Unpublished study received Apr 28,
1978 under 35317-1; prepared by Union Carbide Corp., submitted
by Kuehne Chemical Co., Inc., Cranford, N.J. *, CDL:233599-A)
00007285 Paa, H. (1977) Report to Allied-Chlorine: Acute Toxicity Studies
with Sodium hypochlorite Solution: 1ST No. 8530-10159. (Un-
published study received Feb 22, 1977 under 33458-5; prepared b<
Industrial Bio-Test Laboratories, Inc., submitted by Allied
Chlorine and Chemical Products, Inc., Miami, Fla.; CDL:231463-A
00007369 Paa, H» (1977) Report to Jones Chemicals, Incorporated: Acute Tox-
icity Studies with Sunny Sol 5.25% Bleach: 1ST No. 8530-10145.
(Unpublished study received Mar 23, 1977 under 1744-1; prepared
by Industrial Bio-Test Laboratories, Inc., submitted by Jones
Chemical, Inc., Caledonia, N.Y.; CDL:231821-A)
39
-------
00007374 Baker, R.G. (1976) Report to Jones Chemicals, Inc.: Acute Toxicity
Studies with Sodium hypochlorite, Sunny Sol 150: IBT No. 8530-
09248. (Unpublished study received Sep 7, 1976 under 1744-2;
prepared by Industrial Bio-Test Laboratories, Inc., submitted bj
Jones Chemicals, Inc., Caledonia, N.Y., CDL:225754-A)
00007381 Palanker, A.L. (1975) Final Report: Acute Inhalation in Rats; Acute
Oral LD 50* in Rats; Eye Irritation in Rabbits; Dermal Irrita-
tion in Rabbits; Acute Dermal Toxicity in Rabbits. (Unpublished
study received Mar 3, 1975 under 1258-161; prepared by Biometric
Testing, Inc., submitted by Olin Corp., Stamford, Conn.; CDL:
233785-A)
00007397 Babish, J.G, (1978) Report: Approximate Acute Oral Toxicity
(LD 50A) in Rats. (Unpublished study received Jan 19, 1979
under unknown admin, no.; prepared by Food and Drug Research
Laboratories, Inc., submitted by Chlorine Institute, Inc.,
New York, N.Y.; CDL:236802-B)
00007398 Babish, J.G. (1978) Report: Acute Dermal Toxicity Study in Rabbits.
(Unpublished study received Jan 19, 1979 under unknown
admin, no.; prepared by Food and Drug Research Laboratories,
Inc., submitted by Chlorine Institute, Inc., New York, N.Y.;
CDL:236802-C)
00007399 Babish, J.G. (1978) Report: Approximate Acute Oral Toxicity
(LD 50A) in Rats. (Unpublished study received Jan 19, 1979
under unknown admin, no.; prepared by Food and Drug Research
Laboratories, Inc., submitted by Chlorine Institute, Inc.,
New York, N.Y.J CDL:236802-F)
00007400 stiefel, C.; Fratus, G.j Hawes, M.; et al. (1978) Acute Toxicity
of Sodium hypochlorite to Rainbow Trout ( "Salmo gairdneri "):
Report No. BW-78-8-280. (Unpublished study received Jan 19,
1979 under unknown admin, no.; prepared by EG&G, Bionomics,
submitted by Chlorine Institute, Inc., New York, N.Y.;
CDL:236803-B)
00007401 Buccafusco, R.J.; Hawes, M.; Stiefel, C.; et al. (1978) Acute
Toxicity of Sodium hypochlorite to Bluegill ( "Lapomis machro-
"chirua ")s Report No. BW-78-7-234. (Unpublished study re-
ceived Jan 19, 1979 under unknown admin, no.; prepared by EG&G,
Bionomics, submitted by Chlorine Institute, Inc., New York,
M.Y.» CDLS236803-C)
00007402 LeBlanc, G.A.; Surprenant, D.C. (1978) Acute Toxicity of Sodium
hypochlorite to the Water Flea ( "Daphnia raagna "): Report No.
BW-78-7-206. (Unpublished study received Jan 19, 1979 under un
known admin, no.; prepared by EG&G, Bionomics, submitted by
Chlorine Institute, Inc., New York, N.Y.I CDL;236803-D)
40
-------
i
00007403 Beavers, J.B.; Fink, R.; Grimes, J.; et al. (1978) Final Repor*
Acute Oral LD50—Bobwhite Quail: Project No. 158-103. (Unpi
lished study received Jan 19, 1979 under unknown admin, no.; """"
prepared by Wildlife International, Ltd. in cooperation with
Washington College, submitted by Chlorine Institute, Inc.,
New York, N.Y.; CDL:236804-B)
00007404 Beavers, J.B.; Fink, R. ,* Grimes, J. ; et al. (1978) Final Report:
Eight-Day Dietary LC50—Mallard Duck: Project No. 158-102.
(Unpublished study received Jan 19, 1979 under unknown admin.
no.; prepared by Wildlife International, Ltd. in cooperation
with Washington College, submitted by Chlorine institute, Inc.,
New York, N.Y.; CDL:236804-C)
00007405 Beavers, J.B.; Brown, R, (1978) Final Report: Eight-Day Dietary
LC50—Bobwhite Quail: Project No. 158-101. (Unpublished study
received Jan 19, 1979 under unknown admin, no.; prepared by
Wildlife International, Ltd., submitted by Chlorine Institute,
Inc., New York, N.Y.; CDL:236804-D)
00007495 Buccafusco, R.J.; LeBlanc, G.A. (1977) Acute Toxicity of HTH to
Bluegill ( "Lepomis macrochirus" ), Rainbow Trout ( "Salmo"
gairdneri) and the Water Flea ( "Daphnia magna" ). (Unpub-
lished study including letter dated Aug 15, 1977 from S.J. Bar-
bee to R.L. Bertrand, received Sep 8, 1977 under 1258-427; pre-
pared by EG&G, Bionomics, submitted by Olin Corp., Stamford,
Conn.; CDL:231907-A)
00007496 Beavers, J.B. (1977) Final Report: Acute Oral LD50—Bobwhite c
Project No. 133-107. (Unpublished study received Sep 8, 19
under 1258-427? prepared by Wildlife Int., Ltd. in cooperation"
with Washington College and Maryland, Dept. of Agriculture, Div
of Inspection and Regulation, submitted by Olin Corp., Stamford
Conn.; CDL:2319Q7-B)
00007498 Martin, H. (1961) Guide to the chemicals Used in Crop Protection.
4th ed. By Univ. of Western Ontario, Pesticide Research Insti-
tute. ?:Canada, Dept. of Agriculture, Research Branch, (p.
27 only? Publication 1093,* also'In'unpublished submission re-
ceived Jan 26, 1965 under unknown admin, no.; submitted by Olin
Corp., Stamford, Conn.; CDL:005734-B)
00007540 New England Tasting Laboratory, Incorporated (1977) Certificate of
Analysis; Analysis for: Oral LD50, Primary Dermal Irritation,
Primary Eye Irritation, Dermal LD50. (Unpublished study re-
ceived May 9, 1977 under 1763-2? submitted by Fields Point
Chemical, Inc., Providence, R.I.; CDL:230000-A)
00007560 Lavenhar, S.R. ,* Palanker, A.L. (1975) Final Report: Acute Inhala-
tion Toxicity in Rats. (Unpublished study received May 19,
1977 under 1258-427; prepared by Biometric Testing, Inc., sub-
mitted by Olin Corp., Stamford, Conn.; CDL:230229-J)
41
-------
i
00007580 Goldhammer, R.E. (1973) Acute Inhalation in Rats: Acute Oral
LD 50A in Rats; Eye Irritation in Rabbits: Dermal Irritation in
Rabbits. (Unpublished study received Jul 2, 1973 under 1258-
971; prepared by Bio-metric Testing, Inc., submitted by Olin
Corp., Stamford, Conn.; CDL:239291-A)
00007588 Campanella, J.L. (1974) Laboratory Report: Sodium hypochlorite.
(Unpublished study received Oct 1, 1974 under 1763-2; submitted
by Fields Point Chemical, Inc., Providence, R.I.; CDL:239326-A)
00008190 Calmbacher, C.W. (1978) Acute Toxicity of Sodium hypochlorite Solu-
tion to the Bluegill Sunfish'Lepomis macrochirus'Rafinesque:
UCES Proj. No. 11506-72-01. (Unpublished study received Apr 4,
1978 under 35317-1; prepared by Union Carbide Corp., submitted
by Kuehne Chemical Co., Inc., Cranford, N.J.; CDL:233389-A)
00008191 Calabacher, C.W. (1978) Acute Toxicity of Sodium hypochlorite Solu-
tion to the Rainbow Trout,"Salmo gairdneri"Richardson: UCES
Projt, No. 11506-72-02. (Unpublished study received Apr 4,
1978 under 35317-1; prepared by Union Carbide Corp., submitted
by Kuehne Chemical Co., Inc., Cranford, M.J.; CDL:233390-A)
00008202 Baker, R.G. (1974) Report to Olin Corporation: Primary Skin Irrita-
tion Test with Mildew Rid in Albino Rabbits: IBT No. 601-05594.
(Unpublished study received Mar 3, 1975 under 1258-161; prepare*
by Industrial Bio-Test Laboratories, Inc., submitted by Olin
Corp., Stamford, Conn.; CDL:233785-B)
00008203 Babish, J.G. (1978) Report: Primary Skin Irritation Study with
Rabbits. (Unpublished study received Jan 19, 1979 under unknow:
adain. no.; prepared by Food and Drug Research Laboratories,
Inc., submitted by Chlorine Institute, Inc., New York, N.Y.;
00008204 Babish, J.G. (1978) Report: Eye Irritation Test in Rabbits with
Fluorescein. (Unpublished study received Jan 19, 1979 under
unknown admin, no.; prepared by Food and Drug Research Labora-
tories, Inc., submitted by Chlorine Institute, Inc., New York,
N.Y.? CDLI236802-E)
00008205 Babish, J.G. (1978) Report; Primary Skin Irritation study with
Rabbits. (Unpublished study received Jan 19, 1979 under unknow
admin, no.; prepared by Food and Drug Research Laboratories,
Inc., submitted by chlorine Institute, Inc., New York, N.Y.;
CDL:236802-G)
00008206 Babish, J.G. (1978) Report: Eye Irritation Tests in Rabbits with
Fluorescein. (Unpublished study received Jan 19, 1979 under
unknown adain. no.; prepared by Food and Drug Research Labo-
ratories, Inc., submitted by Chlorine Institute, Inc., New
York, N.Y.j CDLJ236802-H)
42
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00019313 LeBlanc, G.A. (1977) Acute Toxicity of Sodium hypochlorite sol'
to the Water Flea { "Daphnia magna") ; ICG/T-78-076. (Unpul _^.
lished study received Dec 7, 1978 under 230-69; prepared by "*"
EGiG, Bionomics, submitted by FMC Corp., Industrial Chemical
Group, Philadelphia, Pa,; CDL:236584-B)
00020072 Drube, R. (1978) Acute Oral Toxicity, Acute Dermal Toxicity, Pri-
mary Skin Irritation and Corrosivity, and Acute Eye Irritation
Studies of Sodium hypochlorite Solution C (Surchlor, Sur-Shock)
(Unpublished study received Jul 18, 1979 under unknown admin,
no.; prepared by Hill Top Research, Inc., submitted by Surpass
Chemical Co., Inc., Albany, N.Y.j CDL:238938-B)
00025213 whitex Company (1976) Manufacturing Procedure for Jones Chemicals,
Inc.: Sunny Sol 5.25% Bleach. (Unpublished study received Jun
13, 1977 under 40703-1; CDL:230635-A)
05009652 Mandell, H.C., Jr. (1971) A new calcium hypochlorite and a
discriminatory test. Fire Technology 7(2);157-161.
05011175 Khanna, V.B.; Sharma, S.K.? Bhattacharya, A.K. (1970) An
iodimetric method for the determination of available chlorine
in bleaching powder. Indian Journal of Applied Chemistry
33(3):199-200.
05011199 Taylor, R.L, (1917). The effect of light on solutions of bleaching
powder. J. Soc. Dyers Colourists. 33: 246-250.
05012141 Ramaswamy, S.; Kalyanam, N. (1951) Preparation of calcium
hypochlorite with 70-73 per cent available chlorine. Journ^
of Scientific and Industrial Research 108:282-287. '~~
05014892 Kukielka, J.; Kupiec, S. (1975) Metody wytwarzania podchlorynu
wapniowego_ [Methods of producing ealciua hypochlorite_]
Przemysl Chemiczny. {Chemical Industry.] 54(4):219-224.
05021388 Wong, G.T.F., and J.A. Davidson. (1977). The fate of chlorine in
sea-water. Water Research. 11 (11): 971-978.
40230102 Hinken, C.} Grimes, J.; Jaber, M. (1987) Chloryte Calcium Hypochlori
An Acute Oral Toxicity Study with the Bobwhite: Final Report:
Wildlife International Ltd.: Project No. 226-103. Unpublished st
prepared by wildlife International Ltd. 2ip.
40230103 Grine«,J.? Jaber, M. (1987) Chloryte Calciua Hypochlorite: A o*it
LC50 Study with the Mallard: Wildlife International Ltd. Proj
No.: 226-102A. Unpublished study prepared by wiidl
International Ltd. 17p.
43
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i
40230104 Hinken, C.; Grimes, J. Jaber M. (1987) Chloryte Calcium Hypochlorit*
A Dietary LC50 Study with the Bobwhite: Wildlife International Ltc
Project Ho. 226-101. Unpublished study prepared by Wildlife
International Ltd. 17p.
40911802 Tobler, J.; Cohn, W.; Jolley, R.r at al. (1981) Ambient Water
Quality Criteria for Chlorine. Unpublished study prepared by
Science Applications, Inc. 61 p.
40911811 Bass, M.; Heath, A. (1977) Toxicity of intermittent chlorination to
bluegill, lepomis maerochirus; interaction and temperature.
Bulletin of Environmental Contamination & Toxicology. 17 (4): 41<
423.
40929401 Klein, H. (1988) Product Chemistry: Product Name: HTH Extra Strengi
Duration Tablets for repackaging as a Bactericide and algaecide,
Unpublished compilation prepared by Olin Corp. lOp.
44
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i
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i
APPENDIX D
PR NOTICE 91-2
45
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
PR nevfrem *i— 9 ofFcf
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2.
The upper and lower certified limits, which must b* proposed in
connection with a product's registration, represent the amounts of
an ingredient that may legally be present 40 CFR 158,175. The lower
certified limit is used as the enforceable lover limit for the
product composition according to FIFRA section 12(a)(l)(C), while
the nominal 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 becaus* the nominal concentration would be the amount
of active ingredient typically found in the product.
It is important for registrants to note that certified limits
for active ingredients are • not considered to be trade secret
information under FIFRA section 10 (b) . In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing on
the label may not represent the enforceable composition for
purposes of section 12 (a) (1) (C) .
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SOUGOU," 3
currently registered products mm well as all applications for n^. _ -
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 zinc, 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 nominal
ingredient label claim. Further information about the analysis
requirement may b* found in the 40 CFR 158.170. All products are
required to provide certified limits for each active, inert
ingredient, impurities of toxicological significance (i.e. , upper
limit (s) only) and on a case by case basis as specified by EPA.
These. limit* are to be set based oa representative sampling and
chemical analysis ( i. e. , quality control) of the product.
The format of the ingredient statement must conform to 40 CFR
156-Labeling Requirements For Pesticides and Devices.
After July lv 1S97, ell. pesticide ingredient statements must
be changed to nominal concentration,
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lov«r limits may not be lower than the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten th»
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 158.640.
In those cases where efficacy liaits hav» been established,
the Agency will not accept certified lower liaits which are below
that level for the shelf life of'the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to nalce
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority program*, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefor*,
applicants/registrants are expected to comply with the
requirements of this Hotice as follows:
(1) Beginning July 1, 1991, all new product
registrations submitted to the Agency
are to comply with th« reguirements of this
Notice.
(2) Registrants having) products subject to
reregistration under FIFRA section 4 (a) are to
comply with the requirements of this Notice when
specific products ar* called in by the Agency
under Phase V of the Reregistration Program.
(3) All other products/applications that are
not subject to (1) and (2) above will have until
July i, 1997, to comply witn this Notice.
Such applications should note "Conversion
to nominal Concentration* on toe application
for». These types of amendments will not be
handled as "Fast Trade* applications but
will be handled as routine requests.
vi. FOX fmsmi INFORMATION
Contacts Tyrone Aiken for information or questions concerning
this notice on (703) 557-5024.
C-
Anne I. Lindsay, Director
Registration Division (H-7505
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I
v>EPA
UntttdStitM Offc»o<
Environm»ntal Protection P«»tcid» Program*
Agtney
October 1991
Pesticide
Reregistration
Handbook
How to Respond to
the Reregistration
Eligibility Document
(RED)
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PESflCIDB RERSGI3TRATIOH HANDBOOK
HOW TO RESPOND TO THE
REKEGISTRATIQN ELIGIBILITY DOCUMENT (BED)
07TICB 07 PBSTICIDI PRQORAKB
ENVIRONMBMTAL PIU3TBCTIOM AQBMCT
OCTOB1R lit!
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PRODUCT REEEQISTRATION HANDBOOK
TAILS OF CONTENTS
I. Introduction
A. Purpose and Content i
B. Reregistration Eligibility Document i
C. Rersgistration Process , i
II. Instructions for Responding
A. How and When to Respond 2
B. When No Response Is Needed s
B. Where to Respond 6
III, Submission of Data and Labels/Labeling
A. Generic Data 6
B. Product Specific Data ?
1. Product Chemistry 7
2. Acute, Toxicity 8
3. Product Performanc* 9
C. Labels/Labeling 10
Appendix
A. Confidential statement of Formula and Instructions
B. Label Contents
C. Sample Label Formats—General U»e i Restricted Use
D. Label Regulations (40 CFR 156.10)
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PESTICIDE RERESISTRATI3K EAHDSOOK
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 »RIO") and how to reregister products.
Section I is this introduction.
Section II contains step-by-step instructions which must ba
followed by registrants responding to the RED.
Section III provides additional instruction* on the format,
content and ether aspects of generic data, product specific data
and labels/labeling which may b* required to be submitted.
Detailed instructions are in the Appendix.
B. Thes Reregistration Eligibilit
Under Section 4 of th* Federal Insecticide, Fungicide and
Rodenticide Act (FIFEA) , as amended in 1988, EPA is required tc
reregister pesticides that were first registered before November 1,
1984. The RED describes in detail the subject chemical, its *
and its regulatory history; describes EPA's decision concernir
eligibility of th* uses of th* chemical for reregistration, j
explains th* scientific and regulatory bas*s for this decision.
EPA's reviews of th* data by scientific discipline are available
upon request. Appendices to th* RED contain: (1) a Data Dall-Ir
Notic* 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 th* generic studies EPA has reviewed.
C« Th«! Rereaistration Process
R*r*gistration involves a thorough review of th* scientific
data bas* underlying a pesticide'* registration. Th* purpose oi
SPA's r*vi*tr is to reassess th* potential hazards arising from thi
currently registered uses of the pesticide, to determine whethei
th* data bas* is substantially complete or there is need foi
additional g*n*ric data, and to determine wh*th*r th* pesticide is
eligibl* for reregistration. This decision is issued as the RED.
EPA's science review* and information on.th* registered
uses consider*d for EPA's analyses nay b* obtained from: EPA,
Freedom of Information, 401 M St., S.W., Washington, D.C7 20460.
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If the RED declares that some or all uses of the chemical are
eligible for reregistration, affected registrants nust 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 RID 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 the RED.
fOft 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
thes* steps exactly to avoid suspension of their products. All
products containing the motive ingredient ia the RBD [i.e.,
manufacturing use products, end use products end specie! local seed
(BUS o* flection 24o) registrations] ere subject te the requirements
of the RID. Figure l summarizes how and when to respond to the
RED. A step-by-step explanation follows.
Step 1. Are Expedited. Label, Changes Requ^refl? In some
instances, EPA nay conclude that certain changes to product
labels/labeling must be implemented rapidly. If the RBD requires
expedited label /label ing changes, registrants must submit the items
below by the deadline apacified in the RID. If expedited label
changes are not required, go to Step 2.
a. Application for Registration (EPA Fora 8570-1) . Complete
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and sign the form. In Section II, insert the phrase "Expedited
Amendment in Response to the Raregistration 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 fora 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.
Steo 2. Are data repaired? If the RED require* generic or
product specific data, you must follow the directions in the data
call-in notice ia the RED. All registrants Bust respond for all
products within 90 days of receipt; products for which an adequate
response is not received on time will b* subject to suspension. MO.
tine extensions will be given for responding within 90 days.
9ttP ?. Are Uses of a Pesticide Eligible for Rareaistration?
If any uses of the active ingredient(s) covered by the RED are
eligible for reregistration, follow these instructions. If no. uses
are eligible, as 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 any uses of a
cheaical are eligible for reregistration, registrants for
manufacturing-use products (MPs), end-use products (EPs) ar
special local needs registrations (SXJfs), must submit the iter
below for each product within B months of the date oC issuance 4
the RJSD: -
a. Application for Reregistration (use if A Torn 8570-1).
Complete and sign the fora. In Section II of that fora, check the
box "Other" and insert the phrase "Application for Reregistration."
Os* only an original application fora with a red identifier number
ia the upper right-hand corner.
b. five (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 say delete such uses
and avoid all requirements and consequences which may be associated
vita 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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BOW AND WHIM TO RESPOND TO TOT REREOISTRATION
ELIGIBILITY DOCUM2NT (MD) TOR MMTOFJICfTOIlKI USB
PRODUCTS (MIS) , END-0SB PRODUCTS (EPS) end SPECIAL
LOOM, NEEDS REGISTRATIONS (SLN»).
STEP li Are expedited label revisions required?
Yea .s No
Submit application
and labels on
expedited schedule
specified in RED.
STEP 2t
8TIP 3!
Are data required?
Yes
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c. Product Specific Data. You must follow the instructions—
is til* Data call-la Notice ia the RED aad ia section XIX of this
Handbook. Responses to the data call ia ar* du* within 90 days of
receipt of th* RED and submission or citation of data ia du* within
8 months of th* issuance of to* RED.
d. Two (2) copies of the current Confidential Statement of
Formula (EPA Form 8570-4, revised February 85). TWO completed and
signed CSF forms must be submitted for the basie formulation and
for each alternate formulation. If csFs are not provided for the"
alternate formulas, they will aot ba reregistered and will no
longer be acceptable. The Appendix of this Handbook has specific
instructions for completing the CSF fora.
e. certification with Respect to Citation of Data (EPX ?orm
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 tvo possible reasons:
--Available data indicate that on* or more of th* criteria for
an in-depth special review have been met;
—Additional generic data are required.
In th* first instance, if th* active ingredient is placed into
special review, reregistration activities associated with those
uses of th* 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 th* second instance, based upon the review of studies for
an active ingr*di*nt during reregistration, additional generic data
(e.g., second- or third-tier studies) aay be needed (see the RED) .
In such cases, th* chemical's uses will not be eligible for
reregistration until the additional generic data have been
submitted to and reviewed and found acc*ptabl« by EPA* It th* data
ar* 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 th* data ar* not submitted, products containing the active
ingredient may b* suspended.
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C. Where to Respond
By U.S. Mail:
Document Processing Desk (insert distribution cod*)
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:
Document Processing Desk (insert distribution ood*)
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
These nailing addresses and the following distribution codas
must ba usad to assura the tiaaly receipt and processing of your
submissions. Not using them may significantly delay the handling
of your submissions:
RBD-SRRD-Jonc (where rax is the case cod* given on the front of
the RID)—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.
RIO-RD-tlGnt (where aoc is the Product Manager team number)--
use this distribution code for all responses pertaining to or
containing productspecific 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/L
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.
I
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Any new data requirements and how thay affect raregistraticn
eligibility of a chemical are discussed in the RED. If new generic
data requirements are imposed in a Data Dall-In 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 Data
Product specific data may be required Cor the reregistraticn
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 retirements for MPs, IPs 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 oC tha'
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. Inerfr Ingredients
EPA has implemented a strategy for regulating inert
ingredients which affects the reregistration of pesticide products.
Thi« 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; i
--Inerts of toxicological concern (List 1} for which available
data demonstrate toxic effects of concern (includes about 50
chemicals).
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3
—Potentially toxic inerts (List 2) for which only limited
-data are available, but such data or th« 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 bas 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 DCI, or other activity under
the inerts strategy.
Any product containing a tist 2, 3 or 4 inert may be
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 1, products containing that
inert would become ineligible for reregistration. Inert
ingredients oust also meet normal registration and tolerance
requirements, a* applicable.
2. Acute Toxicitv
The data call-in notice in the RED specifies the acute
toxicity data required for reregistration of each HP or EP. it
indicates whether any of the standard tests have been waived and,
if so, why.
If feasible, EPA will "batch11 products that are similar with
respect to their acute toxicity so that one set of -tests c<*n
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. The
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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 testa 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 03ta Submission Waiver Policy
FIFRA gives the Administrator of EPA authority "to waive data
requirements pertaining to efficacy1* 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 typ** 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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b.
10
Claims and Products _{pr Which Efficacy pata Generally
Are Reeruired
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 andLabeling
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
mad* for reregistration include, but are not limited to:
1. Labeling changes specified in the RED. Such changes may
include statements on RESTRICTED USE, groundwater hazards,
protective clothing/equipment, endangered species, environmental
hazard*, 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 P«sticid» Regulatory (PR)
Notices, regulations, regulatory decisions and policies issued by
EPA which ar» relevant to the pesticide. Your product's labeling
must reflect any applicable requirements which are in effect at -he
tins the RED is issued. Some existing notices are referred to in
Section B. of th* Appendix.
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i
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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Instructions .......
F-QrmuJ.a.
Completing the Confidenta Statement of
The Confidential statement of Formula (CSF)' Form 8570-4 oust
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 aust 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 EFA 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 aust be reported under column 10 and must be
exactly the same as on the source product's label.
j. All the weights in columns 13. a. and 13. b. must be in
pounds, kilograms, or grams, in no case will volumes be accepted.
Do not. mix English* and metric system units (i.e., pounds and
kilogram*) .
k. Ml the items under column 13. b. must total 100 percent.
1. All items under columns 14. a. and 14. b. for the active
ingredients must represent pure active font.
m. The upper and lower certified limits for all active and
inert ingredients must follow the 40 CFR 158. 17S instructions. An
explanation must be provided if the proposed limits are different
than standard certified limits.
n. When new GSFs are submitted and approved, all previously
submitted CSFs become obsolete for that specific formulation.
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B. INSTRUCTIONS FOR LABEL CONTENTS
40 CFR 156.10 and Pesticide Regulatory (P,R.) Notices require
that specific labeling statements appear at certain locations on
the label. The sample label formats in Appendix C show where these
statements are to be placed.
Item 1. PRODUCT NAME - The nane, brand or trademark is required to
be located on the front panel, preferably centered in the upper
part of the panel. The name of a product will not be accepted if
it is false or misleading. [40 CFR 156.1Q(b)]
Item 2. COMPANY NAME AND ADDRESS - The name and address of the
producer, registrant or person for whoa 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 156.10(c)]
Item 3. NET CONTENTS - A net contents statement is required on all
labels or on tha container of th» pesticide. Th* preferred
location is the bottom of the front panel immediately above the
company name and address, or at the and of the label text. Th« net
contents must b* expressed in the largest suitable unit, e.g., "1
pound 10 ounces" rather than "26 ounces." In addition to English
units, net contents may be expressed in metric units. [40 CFR
156.lO(d>]
Item 4. EPA REGISTRATION NUMBER - Th* registration number assigned
to the pesticide product must appear on the label, preceded by the
phrase "SPA Registration No.," or MEPA Reg. Mo.11 The registration
number must be sat in type of a size and style similar to other
print on that part of the label on which it appears and must run
parallel to it. The registration number and the required
identifying phrase must not appear in such a manner as to suggest
or imply recommendation or endorsement of the product by the
Agency, [40 CFR 156.10(a)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is the final establishment at
which the product was produced, and aay appear in any suitable
location on the label or immediate container. It must also appear
on the wrapper or outside container of the package if the EPA
establishment number on the immediate container cannot be clearly
read through such wrapper or container. [40 CFR I56.l0(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
normally required on the front panel. The ingredients statement
must contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredient*. The preferred location is immediately below the
product name. The ingredient* 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
Item 6B. POUNDS PER GALLON STATEMENT - For liquid
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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 naae, if there is one, shall be used, followed by the
chemical name. If no common naae has been established, the
chemical name alone shall be used. Chemicals related to the active
ingredient are allowed to be listed pnj.y if efficacy data
supporting such claims are submitted or referenced. If such data
are provided, the related chemicals must be listed sepqratej.y 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
oust 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 show* 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
AJ4 capitals, ,, ,.
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
Minimum Type ?ize
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 156.I0(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 CFi I56.l0(h)(l)(i)].
-MCC
V-
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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
CFH 156.10(h)(1)(ill)]
Item 7E. REFERRAL STATEMENT - The statement "sea 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 CFH 156.LO(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. C«Q CFR I56.l0(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY Precautionary
statements relating to flammability of a product ar* 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 - FZFRA sec. 3 (d) requires
that all pesticide formulations/use* be classified for either
general or restricted use. Products classified for restricted ut»e
may be liaited 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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i
1. Ml uses 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 terns 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 th« Certified Applicator's Certification." The RED
will specify what statement oust be used,
2. some but sot 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 dc
so, you may include on the label uses that an
unrestricted, but you may not distinguish them on the
label as being unrestricted.
b. You nay 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
separate 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
labels. 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.11 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
has been established by the Agency, it must be included on the
label. Additional worker protection statements may be required in
j
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hi
accordance with PR Notice 33-2, 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 ar* 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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Prete«t!en Agency
hnjjtt«r has asserted » confidential
information claim concerning
(5) A copy of each document, propos-
.1 or other item of written material
concerntaf the R*I**tration Standard
orovided 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 ha*
determined that a substantially com-
plete chronic health and teratology
data base exists, a copy of the FEDERAL
EcctsrcR 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 FDCRAL Rsoism
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:
(!) 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 redpientCs),
and ths> date the document was re-
ceived or provided by the Agency.
Cdl AwMatMity of docfcct and indi-
ct*. <1) Tn* Agency will make avail-
able to tilt public for inspection and
copying tilt docket and Index for any
Registration Standard.
(II The Agency will establish and
*B* to submit chronic health.
(including, but not limited to, chronic
feeding, oncogeniclty and reproduc-
tion) or teratology studies.
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1154.10
* lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(1) The name, brand, or trademark
under which the product is sold as pre-
scribed In paragraph (b) of this sec-
tion;
(11) The name and address of the
producer, registrant, or person for
whom produced as prescribed In para-
graph (c) of this section;
(ill) The net contents as prescribed
in paragraph (d) of this section;
(iv) 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;
of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed In paragraph (h)
of this section:
(vlii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classifications) as pre-
scribed in paragraph 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
conspicuousness (as compared with
other words, statements, designs, or
graphic matter oa the labeling) and
expressed la such terms as to render It
likely to be read and understood by
toe ordinary individual under custom-
~ary conditions of purchase md use.
es(l< lilsl and non-p*s-
Examples of statements
presentations in ' the labeling
or
which constitute misbrandlng include:
(1) A false or *f«t1**
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Protection Agency
(jj) A f*lse or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(111) A false or misleading statement
about the value of the product for
purposes other than ss a pesticide or
device;
(iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredient* even though the
names of the other ingredients are
stated elsewhere in the labeling;
A true statement used in such a
way as to give a false or misleading Im-
pression to the purchaser;
(vtii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions:
(lx) Claims as to the safety of the
pesticide or its ingredients, including
statements such u "safe." "nonpoison-
ous," "noninjurious." "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to;
(A) "Contain! all natural Ingredi-
ents";
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1 154.10
40 C«
(7-1-tf
«?whiSTit wean end shaU run par-
* It The registration number
«?e ****** identify** phrase
not appear to such a manner s*
toguggest or Imply recommendation
or endorsement of the product by the
(f) Producing establishment* rtgto-
tration number. The producing estab-
Ilshment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear Is any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
padcace If the EPA establiihment reg-
istration number on the immediate
container cannot be clearly read
through tuch wrapper or container.
(g) Ingredient statement— 41) Gener-
al The label of each pesticide product
mutt 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-
ent*; sad if the pesticide contains ar-
senic In say form, a statement of the
percentages of total aad water-soluble
arsenic calculated as elemental ar-
senic. The active ingredient* must be
designated by the term "active ingredi-
ent*" and the Inert Ingredient* by ttte
tern "inert ingredient*," or the singu-
lar forms of these terms when appro-
priate, Bom terms sltall be in the
same type stes, be aligned to the same
margin sad be equally prominent. The
"Inert Ingredient*, none" Is
not required for pesticides which con-
tain 100 percent active ingredient*.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall net be used as a
heading for the ingredient statement.
(2) PoiiUo* of inyndient statement
(I) The Ingredient statement is nor-
mally required on the front panel of
the labeL If there is an outside COR.
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.
(U) 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) Name* 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 ease
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 25ositkHi *••
nlficantly must meet the following la-
beling requirements:
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Prelection Ag.ncy
,n in cases where it ia determined
"; 4 pesticide formulation changes
^mical composition significantly.
fhe product must bear the following
tjitement in a prominent position on
fhe label: "Not for sale or use after
(ii) The product must meet all label
Claims UP to fcne expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
ingredients) to be listed in the
dient statement if he determine*
such ingredient(s) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
§ 154.10
the general areas of toxiejlogicml
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 Toxicity 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:
I
tl
IV
Up to *nd Mfatfne SO
fl*/k»
Up to tnd noudno .2
nt/Wr.
up to trat naudng 200
""**••
From SO flwu
FnsHi J nu 2 Wf/mr..
ftwn iOO awu 2000 .,...,.
CtunwH opaeay
7(
•in
900 ff*u sooo «*t/
nnx* tun sooa
MM 20 mg/lnr..
Awn 1000 ton 20,000.,
« 72
l 20.000.
new*.
MM ar tfgN
71
(i) Human hazard signal word—
roxicity Category L All pesticide prod-
uct* meeting the criteria of Toxicity
Category I shall tear on the front
panel the signal word "Danger." In ad-
dition if th» product was assigned to
Toxicity Category I on the basis of Its
oral, inhalation or dermal toxlcity (aa
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
c color *Ty* the
crosabonca1 ffhtiTI appear in i"fti*i
proximity to the word "poison."
(B) Toxicity Cattgon II. All petti*
dde producta meeting the criteria of
Toxicity Cmteffory IX shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicitv Category III. All pesti-
cide product* meeting the criteria of
Toxicity Category ZZX shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide product! meeting the criteria of
Toxicity Category IV snail bear on the
front panel the signal word "Caution,"
(X) Cfte o/ tignal word*. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling to necessary to pre-
vent unreasonable adverse effect! on
pmn or the environment. In no case
shall more man one human hazard
signal word appear on the front panel
of alabeL
(11) Child htuard warning. Every pes-
ticide product laoel shall bear on the
front panel the statement "keep out of
reach of children." Only in* cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicant to be extremely remote,
or if the nature of the pesticide is-such-
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that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
fiil) Statement of practical treat-
m«ftl—(A) Toricity Category L A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
Ing into Toxidty Category I on the
basis of oral, inhalation or «*nuiltos>
idty. The Agency may, however,
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
meat on back panel" *»P«»r» <» **»
front panel near the word "Poison"
nad the skull and erossbones.
(B> Other toxicitv categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXiUXA) of
this section. The applicant may, how-
ever, Include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph
OwX
10
12
14
It
10
12
(2) Other rtqvind teaming and pr«.
cautionary ttatemenU. The waramgs
and precautionary statements at re.
quired below shall appear together on
the label under the general headtaf
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" 4*i«j
"Physical or Chemical Hazard."
(i) Haxard to human* and doiruutic
animals. (A) Where a hazard exists to
humans or domestic *"
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i
Protection Agency
hazard*. Where a
exist* to non target organism*
n»—-jmf human* and domestic ani-
«s<5lu artcautionary statements are re-
s&rLii stating the nature of the
and the appropriate precau-
MJ avoid potential accident,
Or damage. Examples of the
statement* and the circum-
under which they are required
§ 1M.IO
LC» of 500 ppm or less, th« statement
"This Pesticide f* Toxic to v/iidlife" is
required.
(D) II either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or m**m*^« the statement
a pesticide Intended for out-
use contain* an active ingredient
a miffim*H*r> acute oral LD«. of
r lea*, the statement "This Pesti-
I* Toxic to Wildlife" is required.
) If a pesticide intended for out-
door use contains an active ingredient
«ith a fi»h acute LCi* of 1 ppm or lest,
Restatement "This Pesticide I*Toxic
to Fish" is required.
(C) If * pesticide intended for out*
door use contains an active Ingredient
with an avlan acute oral LDM of 100
tag/kg or lest, or a subacute dietary
"This pesticide is extremely toxic to
wildlife (fish)" Is required.
Placement o/ directtoiu for
Direction* may appear on any portion
of UM label provided that they are
concpicuou* fmovgh to be rssllj read
by UM user of UM pesticide product.
Direction* for use may appear on
printed or graphic matter which ac-
companies UM pesticide provided that:
(A) If required by UM Agentey. such
printed or graphic matter is securely
attached to each package of the pestP
dde, or placed within the outside
or bar. ^
81
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Prelection Agency
(*) Any limitation* or restriction* on
«f required to prevent unreasonable
2vt 09 effects, such as:
(A3 Required intervals between ap-
olicatlon »nd harvest of food or feed
Rotational crop restriction*.
,(••) warnings as required against use
certain crops, animals, objects, or
if or adjacent to certain areas.
(D> [Reserved!
(E) For restricted use pesticides, a
statement that the pesticide may be
implied under the direct supervision of
» certified applicator who Is not phys-
ically present at the site of application
Sut nonetheless available to the
oerson 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.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
fflfj* and the environment.
()) Statement of Use Classification.
By October 22, 1979. all pesticide prod-
ucts must bear on their labels a state*
ment of use classification as described
in paragraphs (j) (1) and (2) of this
section. Any pesticide product for
which soot* uses are classified for ten*
era! use and others for restricted use
shall be separately labeled according
to the labeling standards set forth In
this subsection, and shall be marketed
as separate product* with different
registration numbers, one bearing di-
rections only for general use and
the other hearing directions for re-
stricted use(s> except that. If a product
has both lesUkted use and general
use*!). both of then HIM may appear
on a product labeled for restricted use.
Such product* shall be subject to the
proTlsiom of paragraph (JK2) of this
(1) General Urn Classification. Pesti-
dde producta bearing direction* for
used} ftaatifitit general shall be la-
beled with the exact words "General
Classification" 'miff******1? below the
heading "Directions for Use." And ref -
to the general cla
§ 154.10
considered a false or misleading state-
ment under the statutory definitions
of mlsbranding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for u«
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„ 5156.10
(B) The label bears a reference to
the direction* for use to accompanying
leaflet! or circular!, luch u "See di-
rections la the enclosed circular" and
(C) The Administrator determines
that It is not necessary for such direc-
tion* to appear on the label
(Hi) Exception* to requirement for
direction for u*«—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manuf acturint processes,
provided that:
(1) The label clearly shows that the
product is intended for use only to
manufacturing processes and specifies
the typed) of products involved.
(1) Adequate Information such as
technical data sheets or bulletins, is
available to the trade specif ying the
type of product involved and its
proper use in manufacturing process-
es;
(3) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable advene 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:
CD The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions art not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(I) The product it also a drug and
regulated under the provisions of the
Federal Pood, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the 1*¥»l*^g of pesti-
cide product* which are intended for
use only by f ormulators la preparing
pesticides for sate to the public, pro-
vided that:
(I) There is information readily
available to the formulators oa the
composition, toxidty, methods of use,
applicable restrictions or limitations.
40 CM Ch, I (7-1-4.9 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 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 Specific directions concerning
the storage and disposal of the pesti-
cide *jnA its container, meeting the re-
quirements Of 40 CPE Part 166. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard wag-
ing. (See Table in 1!«2.10(hXlXivjf
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I
APPENDIX E
DATA CALL-IN
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i
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y"!r%
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
DATA CALL-IN NOTICE
ECU 7 ft I00'
CERTIFIED MAIL TLB t ° *•"" SUBSTANCES
.._ OFFICE OF
0 ft t°"2 PESTCCES AND TOXIC
*• ° '•"
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
£h_ae£, to submit certain product specific data as noted herein to
the U.S. Environmental Protection Agency (EPA, the Agency).
These data are necessary to maintain the continued registration
of your product(s) containing this active ingredient. Within 90
days after you receive this Notice you oust 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 6; 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)j or
3. Why you believe EPA should not require your submission
of product'Specific 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 ResponseForm, 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> (2MB) • Collection of this
information is authorized under the Paperwork Reduction Act by
OMB Approval No. 2070-0107 (expiration date 12-31-92).
AMttfOft AK»«W '
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i
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 Xou 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 iffects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
A - Data Call-JnChemical StatusSheet
B - Data Call-In Response Form
C - Requirements Statusand Registrant's Response Form
D - IfPA Grouping of End-Ose Products for Meeting Acute
Toxicology Data Requirements for Rerecristration
E - EPA Acceptance Criteria
F - f^igt of Registrants Receiving Tliis Notice
Q — Cost Share and Data Compensation Forms, and Product
Specific Data Report Form
SECTION I. WHY YOD 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.
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II-B. §
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1
your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A
and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
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(a).
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
Form, and the Requirements Status and Registrant's Response form.
Attachment B and Attachment c. The Data Call-In Response Form must
be submitted as part of every response to this Notice. In
addition, one copy of the RequirementsStatus and Registrant's
Response Form must be submitted for each product listed on the
DataCall-In Response Forai 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.
I. 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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2. Satisfying the Product Specific Data Requirements of th|s
Notice. There are various options available to satisfy the product
specific data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1
through 6 on the Requirements Status and Registrant's Response Form
and item numbers 7a and 7b on the Data Call-In Response Form.
Deletion of a use(s) and the low volume/minor use option are not
valid options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for
product specific data are discussed in Section III-D of this Notice
and are covered by option 7 on the Requirements Status and
Registrant's Response Form. If you choose this option, you must
submit both forms as veil as any other information/data pertaining
to the option chosen to address the data requirement.
III-C SATISFYINGTHE DATAREQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you
agree to satisfy the product specific data requirements (i.e. you
select option 7a or 7b), then you must select one of the six
options on the Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option
selection should be entered under item number 9, "Registrant
Response." The six options related to data production are the
first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response Form.
These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions
provided in this Section. The options are:
(!) I will generate and submit data within the specified
timeframe (Developing Data)
(2) I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(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 aa 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 confonnance 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.
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The time frames in the Requirements Status and Registrant's
Response Form are the time frames that the Agency is allowing for
the submission of completed study reports. The noted deadlines run
from the date of the receipt of this Notice by the registrant. If
the data are not 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 1FA 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
nay 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 nifltfrer of the product for which data will be
submitted must be noted in the agreement to cost share by the
registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but
will not be submitting the data yourself, you must provide the name
of the registrant Mho 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.
Optipn 3. Offer to Share in the Cost of Data Development —
This option only applies to acute toxicity and certain efficacy
data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing
agreement to meet the requirements of this Notice and have been
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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. IPA 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
Forjm 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,
Option
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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
met;
a. You must certify at the time that the existing study is
submitted that the raw data and specimens from the study are
available for audit and review and you must identify where they
are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP)
regulation, 40 GFR 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 aay be substituted for the original
source as raw data. 'Raw data* may include photographs,
microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from
automated instruments." The term "specimens", according to 40
CFR 160.3(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 believe* 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.
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If you submit an existing study, you must certify that the
study meets all requirements of the criteria outlined above.
If you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. If such study is in
the Agency's files, you need only cite it along with the
notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study — If a study has been classified
as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will review the data submitted and
determine if the requirement is satisfied. If the Agency decides
the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient,
but upgradeable studies will normally be classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a
study may be upgraded, call or write the contact person listed in
Attachment A* If you submit data to upgrade an existing study you
must satisfy or supply information to correct aJU, 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 being
upgraded.
The criteria for submitting an existing study, as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies. Additionally your submission of data intended to upgrade
studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding
protocol compliance with Agency requirements.
Option 6. Citing Existing Studies — If you choose to cite a
study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable
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10
toxicology studies generally will have been classified as "core-
guideline" or "core minimum.11 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 DataCompensation
Requirements.
Registrants who select one of the above 6 options must meet all
of the requirements described in the instructions for completing
the Data Call-in Response Form and the Requirements Status and
Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you
believe it is inappropriate, you must attach a complete
justification for the request, including technical reasons, data
and references to relevant EPA regulations, guidelines or policies.
(Note: any supplemental data must be submitted in the format
required by PR Notice 86-5) . This will be the only opportunity to
state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3(c)(2)(B) of
FIFRA. If the Agency denies your waiver request, you must choose
an option for meeting the data requirements of this Notice within
30 days of the receipt of the Agency's decision. You must indicate
and submit the option chosen on the Requirements Status and
Registrant's Response Form. Product specific data requirements for
product chemistry, acute toxicity and efficacy (where appropriate)
are required for all products and the Agency will grant a waiver
only under extraordinary circumstances. You should also be aware
that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the
original due date will remain in force.
IV. CONSEQUENCES OF FAILURE TO CQHPLY WITH THIS NQTICJ5
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the following:
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11
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 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. Not ice.
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 HI-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 either to:
a. Inform EPA of intent to develop and submit the data
required by this Notice on a Data Call-In Response Form and a
Requirements Status and Registrant's Response Form;
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 DETERMINATION THAT SUBMITTED STUDY IS
The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for
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12
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 (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.
IV-C EXISTING SHOCKS 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 b«
consistent with the Act. You must also explain why an "existing
stocks" provision in 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) a» a
response to this Notice and your product is in full compliance with
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13
all Agency requirements, you will have, under most circumstances,
one year from the date your 90 day response to this Notice is due,
to sell, distribute, or use existing stocks. Normally, the Agency
will allow persons other than the registrant such as independent
distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular
risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day
response period required by .this notice will not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EPA will consider granting an existing stocks
provision.
SECTION V, REGISTRANTS* OBLIGATION TO R1PQRT POSSIBLE
DVERSE 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 t^ie 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 Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation
requests) must include a completed Data Call-In Response Form and a
completed Requirements Status and Registrant's Response Form
(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.
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14
The Office of Compliance Monitoring {OCX) of the Office of
Pesticides and Toxic Substances (OPTS), IPA, will be monitoring the
data being generated in response to this Notice.
Sincerely yours.
A
B
C
D
E
F
G
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
Data Call-in Chemical Status Sheet
DataCall~In Response Form
Requirements Status and Registrant's Response Form
EPA Grouping of End—Use Products for Meeting Acute
Toxicology Data Requirements for Rereaistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product
Specific Data Report Form
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i
ATTACHMENT A
DATA CALL-IN CHEMICAL STATUS SHEET
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ATTACHMENT A
SODIUM AND CALCIUM HYPOCHLQRITE: DATA CALL-IN CHEMICAL STATUS
SHEET
INTRODUCTION
You have been sent this Data Call-In Notice because you have
products containing sodium and calcium hypochlorite.
This attachment, the Data Call-In Chemical Status Sheet.
contains the reregistration regulatory history of
sodium and calcium hypochlorite, an overview of data required by
this notice, and point of contact for inquiries. This attachment
is to be used in conjunction with (1) the Data Call-In Notice,
(2) Attachment 8, the Data Call-In Response Form.. (3) Attachment
C, the RequirementStatus and Registrant'sResponse Form t°x
product specific data,(4) Attachment D. EPA Grouping of Snfl-y_se_
Products for Meeting Acute,Toxicology Data ..Requirements for
Rereaistrati,o^). (5) Attachment 1, gPA, Acceptance Criteria,. (6)
Attachment Ff Liptof all Registrantfsl sent this Data Ca).l-In
Noi;jqet and (7) Attachment G, the Cost Share and Data
Compensation^ Forms for product specific data, and Product
SpecJ.fJ.c Data Report Form for use in replying to this Sodium and
Calcium Hypochlorite Data Call-In. Instructions and guidance
accompany each form.
REREGISTRATION HISTORY
The Agency issued a Registration Standard entitled "Guidance
for the Registration of Pesticide Products Containing As the
Active Ingredient Sodium and Calcium Hypochlorite Salts" (NTIS
PB87-103222) in February 1§86. The registration standard
summarized the available data supporting the registration of
sodium and calcium hypochlorite and determined that the data were
substantially complete. No additional data were required for the
generic data base in the 1986 standard. The requirements listed
in the standard were cited only for those applicants who wanted
to develop their own supporting data rather than rely upon and
offer to pay compensation for the data cited in the standard.
Recently, the Agency conducted a thorough review of the
scientific data base and all relevant information supporting the
reregistration of sodium and calcium hypochlorite and has
reevaluated it* position on data needed to support the continued
registration of sodium and calcium hypochlorite.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the
database for sodium and calcium hypochlorite are listed in the
Requirements Status and Registrant's Response.. Attachment C.
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The Agency has concluded that additional data on
sodium*and calcium hypochlorite are needed in the following
areas: product specific data. The required additional data are
listed in Attachment C.
Depending on the results of the studies required in this
Notice, additional testing may be required.
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 Ruth Douglas at (703) 305-7964.
All responses to this Notice should be submitted to:
Document Processing Desk (RED/RD/PM 32)
Office of Pesticide Programs (H7505C)
Environmental Protection Agency
401 M street, s.w,
Washington, D.C. 20460
RE: Sodium and Calcium Hypochlorite
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i
ATTACHMENT B
PRODUCT SPECIFIC DATA CALL-IK RESPONSE FORM
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i
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I
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE DATA CALX.-IK RESPONSE FORK
Product Specific pat a
This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act. Fill out this form each tine you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response.1*
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.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PH-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-IK 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 vill 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 (HP) for which you
wish to maintain registration, you must agree to
satisfy the data requirements by responding "yes.11
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 "yes11 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.
HOTS; 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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Page 1 of 1
United States Environnental Protection Agency
Washington, D. C. 20460
DATA CALLr-XN RESPONSE
fttSTMCTIOHS: Haas* type or print in ink. Plaoe* road carefully MM attached instructions and supply the Intonation requested
Us* additional sheet(s) If nacestary.
1. Cospany nsM and Address I. Cos* * and MOM
0029 Na « Ca Hypochlorite
4. iM Product
R*gl*trstion
S. 1 Nl*k to
cancel Oil*
product regis-
tration votun-
tartly.
6. Generic pat*
6*. I eat claimimg a Generic
Data Exemption because 1
obtain the active ingredient
froai the sourc* EM rtgis-
t rat Ion nuab*r Us tod below.
N.A.
Mi. 1 agree to satisfy Generic
Data requirement* as indicated
on the attached fora entitled
"Requirement* Status and
Registrant's IcapanM."
N.A.
i
?. Product Specific
Fora Approved
am no. 2070-0107
on this fora.
S. Date and Type of OCI
PRODUCT SPECIFIC
ftB 78 W92
Bat*
7s. My product i* a HUP and
1 oar** to satisfy the HUP
requirement* on the attached
fora entitled "tequl resents
Status and taflstrant'e
letponte."
a. Certification
I certify thet the statisunts Mdo on this fora and all attachment* or* true, occurate, end complete.
1 Acknowledge that any knowingly fals* or •isteading sUtMtnt My bo punishable by fine, ioprisenscnt
or both under applicable law.
ffgnatur* end Title of Company's Authorized leprementatlve _
10. M*M of Cospony Contact
7b'. Ny product Is an BJP and
1 agree to satisfy the iUP
roqylrsMnts on the attached
fora entitled "lequlroMnts
Status and lejlstrant'*
••span**."
9. Bat*
11. Phone Huaber
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i
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I
ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE FORM
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i
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•I 1CZ7XC IK8TRUCTION8 ?OR COMPLETING
OT HlQtflRZXINTS fTATOfl AKD REGISTRANT » • UBSfOltSB FORM
geeifie aa
This form is designed to be used for registrants to respond
to call-in* for generic and product -specific data as part of ^
EPA's reragistration program under the Fsdsral Insecticide
Fungicide and Rodenticlde Act. Although th* fpcp is tha same for
both product specific and generic data, Instruct Jong for
completing tha forms diffar slightly. Specifically, options for
satisfying product specific data requirements do not include (1)
deletion of uses or (2) request for a low volume/minor usa
waiver. These instructions ara for completion of preduqf
specific data requirements.
EPA has davalopad this form individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of items. DO KOT usa this form for any other
activa ingredient.
I tarns 1 through S (inclusiva) will have been praprintad on
tha form. You must complete all other itlms on this form by
typing or printing legibly.
Public raporting burdan for this collection of information
is' estimated to avaraga 30 minutes par response, including tine
for reviewing instructions, searching existing data sources,
gathering and maintaining tha data naadad, and completing and
reviewing tha collection of information. Sand 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 tha Offica of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECITIC DATA
Itea 1-3 Completed by EPA. Not* the unique Identifier uuaber
assigned by EPA In It*n 3. This number atist b* used la
the transmittal doeuaent fee aay data submissions in
_response to this Data Call-In Notice.
Itea 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 nov listed under 40 CFR 158.155
through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference
number is identified.
Itea i. The use pattern(s) of the pesticide associated with the
product specific requirements 1* (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.
Itea 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.
Itea 8. The due date for submission of each study is identified.
Zt is normally based on • months after issuance of the
Reregistratiea Eligibility Document unless EPA.determines
that a longer time period is necessary.
Itaa S. Enter only one of the following response codes for ..eieii
data requirement to show how you iatead to ceaply with
the data requirements listed IB 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 Z have chosen this
option, Z certify that Z will comply with all the
requireaents pertaining to th* conditions for subaittal
of this study as outlined in the Data Call-In Notice.
2. Z hav* entered into an agreement with one or more
registrants to develop data jointly (Cost. Sharing). I
am submitting a copy of this agreement and a completed
"Certification With Respect To Data Compensation
Requirements" fora. I understand that this option is
available only for acute toxicity or certain efficar/
-------
I
data and only if EPA indicates in an attachment to this
Notice that my product i* similar enough to another
product to qualify for ithis option. I cartify that
anothar party in tha agreement is committing to submit
or provida tha required datai if tha required atudy is
; not submitted on time, my product may ba aubjact to
auspanaion.
3. 1 have made offers to ahara in tha eoat to develop data
(Offers to Cost Soars). I understand that this option
is available only for acuta toxicity or certain efficacy
data and only if EPA indicates in an attachment to this
Data Call-in Notice that ay product is similar enough to
another product to qualify for this option. I aa
subaitting evidence that f have made aa offer to anothar
registrant (vho has an obligation to submit data) to
share in the cost of that data. I an also subaitting a
completed "Certification of Offer to Coat flare ia the
Development Data1* form. I am including a copy of ay
• offer and proof of the other registrant's receipt of that
offer. Z am identifying the party which is committing
to submit or provide the required} data; if the. required
study is not submitted on time, ay product may be subject
to suspension. 1 understand that other terms under
Option 3 in the Data Call-In Notice (Section III-C.l.)
apply as veil*
; 4. By the specified due date, Z will submit an existing
study that has not been submitted previously to the
Agency by anyone (Submitting aa Existing itudy). I
certify that this study will meet all the requirements
for submittal of existing data outlined in Option 4 in
I* the Data Call-in Notice (Section III-C.l.) and vill meet
the attached acceptance, criteria (for acute toxicity and
product chemistry data). Z will attach the needed
supporting information along with this response. I also
certify that Z have determined that this study will fill
the data requirement for which Z have 'indicated this
choice.
S. By the specified due date, Z 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 Bay be upgraded and what information is
; required to do so. Z vill provide the MRID or Accession
% number of the study at the due date. Z understand that
the conditions for this option outlined Option S in the
Data Call-in Notice (Section III-C.l.) apply.
6. By the specified due date, Z will cite an existing stuiy
that the Agency has classified as acceptable or ar.
existing study that has been submitted but not revie-•«i
by tha Agency (Citing an Existing Study). Zf Z am citi.-s
-------
another registrant's study, X understand that this option
is available only for acute toxicity or certain efficacy
data and only if the cited study was conducted on ay
product, an identical product or a product which EPA has
"grouped1* with one or more other products for purposes
of depending en the sane data. X may also choose this
option if X aa citing my ovn data. Xn either case, X
will provide the KRID or Accession number(s) for the
cited data on a "Product Specific Data Report11 fora or
in a similar format. If x cite another registrant's
data, X will submit a completed "Certification wttb
Respect To Data Compensation Requirements" fora*
7. X request a waiver for this study because it is
inappropriate for ay product (Waiver Request).• I aa
attaching a complete justification for this request,
including technical reasons, data and references to
relevant IPA regulations, guidelines or policies. (Note:
any supplemental data aust be submitted in the foraat
required by P.R. Notice 86-5]. X understand that this
is ay only opportunity to state the reasons or provide
information in support of ay request. If the Agency
'' approves ay waiver request, I: will not be required to
supply the data pursuant to Section 3(c)(2){B) of FIFRA.
Xf the Agency denies ay waiver request, X aust choose a
method of meeting the data requirements of this Notice
by the due data stated by this Notice. Xn this case, I
aust, within SO days of ay receipt of the Agency's
written decision, submit a revised "Requirements Status
and Registrant's Response" Fora indicating the option
.. chosen.. X 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.
M21£: ¥ou nay provide additional information that doas 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 »o that EPA can ensure that its records are
correct.
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Page 1 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print In Ink. Please read carefully
Use additional aheet(a) if necessary.
1* ClMfMfiy IMMHI •fid Muf tltS
4. Guideline
Requirement
Muaber
61-1 "
pplgifii
61-2 (b
liliilif ill iiiSSi^l-
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Product Identity t coapoaitlonCI)
Illaacsriil-y^
production t foraulation
Discussion of foraation of (1,3)
the attached instructions and supply the information requested
2. Case f and Na*»
0029 Na & Ca Hypochlorite
EPA Reg. No.
i
PJf
11 '.
:;
Preliainary analysis (1,4)
•:
Analytical *ethod (1)
I
Physical state
Halting point {6}
Hi"
Density
10. Certification
I i
! I
1 1
1 i
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x-x:
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Report!
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ABCDEFGHIJKLMNO
;;-::;:>:'::-,.-:>-:'v \-y:'x:i;';X;::-;::>v;;^S:.:;;:"''.!"v-.::'.;;';:::'
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ABCDEFGHIJKLMNO
T. Teat
on this for*.
3. Data and
rOPW wfJpPWrtW _
am HO. 2070-0107
Approval Expires 12-31-92
Typeof OCI
PRODUCT SPECIFIC
IDf 49927-RD-1676
FEB ?8 1992
Substance
7;«f §!§;|!!
MP/TGA
118
«
:'-:¥liRP»
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illllifii;.
MP/TGAI
MP/EP
MP/TGA
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and TGAI
tlllll
MP/TGAtll
MP/EP
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and TGAI
maTI"! /ffl**»'l\ Tr-'^rvAv^S-^-i^S^iUs-:':-:',
mP/TGh£^mmmmm,
r , - v^w.v.v.'WXwJvJX'EvA
MP/TGAI
MP/EP
I certify that the statements s*da on Mils for* and all attachments arc true, accurate, and complete.
1 acknowledge that any knowingly false or Misleading atateavnt *ey
or both under applicable Ian.
Sionature and Titta of Company's Authorized Representative _
be punishable by fins, faprison*ent
.
12. Ka*B of Cowpany Contact ' . ,
and TGAI
11.
8. Tl*a
Frsa
lit
•
8 BIOS.
8 BOS.
„
I BOS.
!ii;«i»osit
8 nos.
ill
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IfllOSll'
>' mos.
ijuosll;
8 mos.
!f|||
ifinosfl!
8 BOS.
Data
9. latlstrant
Response
^i^iij;i|lllil||iftil|
»Mt*M«A Wi^At^rt
• rnone •uaoer
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Page 2 of 3
United States Environmental Protection Agency POT* Approved
Washington, D. c. 20460 «, *. tannm*
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE . , .. . M
Approval Expires 1Z-31-92
INSTRUCTIONS: Please type or print in Ink. Please read carefully
Use additional sheet(s) If necessary.
!• CoiajDeny new* and Address
»
4. Guideline
Requirement
Muter
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g^^,,,,,,,,,^.,_,.
5. Study Title
the attached instructions and supply the Information requested on this for*.
2. Case * and MOM 3. Oate and Type of DC!
0029 Na 6 Ca Hypochlorite - PRODUCT SPECIFIC
IDf 49927-RD-1676
EPA Reg. No. FEB 78 1992
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pK (9)
Oxidizing or reducing action {10}
Explodsbillty (12)
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Nfscibillty (14)
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1
-.';/ :';!•!, .
.;,.,,.;.;,_.;.•
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2
:<:;;::;:;K;:;<
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6. Us*
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFdHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
Initial to Indicate certification as to inforastlon on this page
(full text of certification is on page one).
7. Test
Substance
MP/TGAl"™'v"'""'"""
MP/TGAIiW^PiSs
* ** /.:-^^?rT^i:s«S5«:55»:::¥SS»>:¥:¥
MP
fm^Mz^mtifmtf'.
MP/EP""""^""
MP/EP
EP
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MP/EP
a. TIM
Frane
8 nos.
8 nos.
8 nos.
8 nos.
8 nos.
8 nos.
8 nos.
S'KKS^-SsssSfisSSjSvS^
8 nos.
8 nos.
f. Registrant
Response
:S:::S»;?<«S5¥*»SW«S5iKi::
"^$W3WW$M$£
:S:^i^SS?^::S^^:5^W>^:^
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Oate
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Page 3 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: PI ease type or print in Ink. Please reed carefully
Use additional sheet(s> If neceatary.
1. Co*eny MM and Ad**..
4. Guideline
Requirement
MUtef
81-6
!. Study Title
the attached Instruction* and supply the information requested
2. Case ff and Name
0029 Na & Ca Hypochlorite
EPA Reg. Ho.
Dermal sens! tixat Ion 14}
1
A
|
Progress
Report.
1
2
w?
S
,-;i;M.
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
Initial to indicate certification em to information on thl. page
(full text of certification ia on page one).
r. Teat
Substance
MP/EP
on this form.
S. Date and
Form Approved
ON8 No. 2D70-0107
Approval Expires 12-31-92
Type of DCI
PRODUCT SPECIFIC
IDf 49927-RD-1676
FEB
?B io:S-
8. Time
fraa
•
8 »os.
9. Refittrant
Response
lUittlliill
Data
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Page 1 of i
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case f and Name: 0029 Na & Ca Hypochlorite
keys W» • manufacturing-use product; EP * end-use product; provided forauletors purchase their active IngredientCs) fro* a registered source, they need not submit pr eft*
data pertaining to the purchased product. INOTE: If * product is • 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ fro*, those of the purchased and registered source, users are not subject to any data requirement! identified in the tables.]; TEP • typical end-use product;
TGAI * technical grade of the active ingredient; MI • "pure" active Ingredient; PAIHA • "pure" active Ingredient, radiotabeled.
Use Categories Key:
C - Terrestrial nonfood crop
H - Breenheuse food crop
II * Indoor nonfood
A - Terrestrial food crop
F - Aquatic nonfood Industrial
I * Residential outdoor
• - Terrestrial food feed crop
6 » Aquatic nonfood residential
L * Indoor food
0 - Aquatic food crop
I * Greenhouse nonfood crop
I - Indoor Medical
E - Aquatic nonfood outdoor
J * Forestry
0 - Indoor residential
Footnotes; mw following notes are referenced In colwn two fS. Study Title) of the •JOUIREMEim STATUS HO HEfilSTMNT'S RESPOWC fora.]
frod Cfta* - Beaut ar Otawf eel
1 •equlreMnta pertaining to product Identity, composition, analysis, end certification of Ingredients are detailed further In the following sections: *!S8.155 for
product identity and composition (61*1); •158.160, 158.142. and 158.165 for description of starting MteHals and manufacturing process (61-2); *158.167 for
discussion of formation of Impurities (61-3); *158.1TO for preliminary analysis (62*1); *1S8.175 for certification of Itarfta (62-2); and MM. 180 for enforce**!*
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit Is being sought.
S If the pesticide Is not already under full scale production and an experimental use permit is sought, a discussion of unintentional Ingredients shall be submitted to
the extent this Information Is available.
4 Required to support the registration of eadi manufacturing-use product {Including registered TGAIs) as nail as end-use products produced! by an Integrated system.
Oats on other end-use products will be required on a case-by-case basis. For pesticides In the development state, a rudimentary product analytical method and data
Mill suffice to support an experimental use permit.
S Certified limit* are not required for Inert Ingredients In products proposed for experimental use.
6 Required if technical chemical is solid at room temperature.
7 Required if technical chemical Is liquid at room temperature.
8 Required if technical chemical Is organic and non-polar.
9 Required If test substances are dlsperslble with Mater.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required If product is potentially explosive.
IS Required if product is a liquid.
14 Required If product Is an emulslfiable liquid and la to be diluted Mlth petroleum solvents.
15 Required if end-use product Is liquid and is to be used around electrical equipment.
Acute Tomle - Regular Chemical
1 Hot required if test material la a gas or highly volatile.
2 Hot required If test material Is corrosive to akin or has pH less than 2 or greater than 11.5; such a product Hill be classified aa Texlclty Category I en the basis
of potential eye and dermal. Irritation effect*.
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Page 2 of 2
United States Environmental Protection Agency
Washington, D, C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case f and Na»e: 0029 Na * Ca Hypochlorite
Footnotes (cont.): *
I Mqulrod ff th* product eamlttt of, or under conditions of utt nil I rctult In, m
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-------
i
ATTACHMENT D
EPA GROUPING OF END-USE PRODUCTS FOR MEETING
ACUTE TOXICOLOGY DATA REQUIREMENTS
FOR REREGISTRATION
-------
-------
EPA'S BATCHING OF CMCTuM HXKCHICRITE AND SODIUM HXBXHECKTIE END-USE PRODUCTS
FOR MEETING ACUTE TOXrCTK DATA REQOIHEMEmS FOR REREXHSIKAITCN
In an effort to reduce the time, resources and number of animals needed to
fulfill the acute toxicity data requirements for reregistration of end-use
products containing the active ingredient calcium hypochlarite and sodium
hvpochlorite, the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process include
each product's active and inert ingredients (identity, percent composition and
biological activity), type of formulation (e.g., emulsifiable concentrate,
aerosol, wettable powder, granular, etc.)/ and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the Agency is not
describing batched products as "substantially similar" since some products within
a batch nay not be considered chemically similar or have identical use patterns.
Batching has been accomplished using the readily available information
described above. Frequently acute toxicity data on individual end-use products
have 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.
Registrants of end-use products within a batch may choose to cooperatively
generate, submit or cite a single battery of six acute toxicological studies to
represent all the products within that batch. It is the registrants1 option to
participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a
registrant chooses to generate the data for a batch, he/she must use one of the
products within the batch as the test material. If a registrant chooses to rely
upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria
attached}, the formulation tested is considered by EPA to be similar for acute
toxicity, and the formulation has not been significantly altered since submission
and acceptance of the acute toxicity data.
In deciding how to meet the product specific data requirements, registrants
must follow the directions given in the Data Call-In Notice and its attachments
appended to the RED. The DCI Notice contains two response forms which are to be
completed and submitted to the Agency within 90 days of receipt. The first form,
"Data Call-in Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each
product, including the standard six acute toxicity tests. A registrant who
wishes to participate in a batch must decide whether he/she will provide the data
or depend on someone else to do so. If a registrant supplies the data to support
a batch of products, he/she must select one of the following options: Developing
Data (Option 1), Submitting an Existing Study (Option 4}, Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends
on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to
Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant
does not want to participate in a batch, the choices are Options 1, 4, 5 or 6.
However, a registrant should know that choosing not to participate in a batch
does not preclude other registrants in the batch from citing his/her studies and
offering to cost share (Option 3) those studies.
-------
Single active ingredient calcium hypochlorite or sodium hypochlorite
products that conform to product composition and specifications prescribed in the
Registration Standard of February 1986, titled Guidance for leregistration of
Basticide Products Containing Calcium and Sodium Hypochlorite Salts (Part I,
Section E) have not been included in the batch tables that follow. Due to the
very narrow product conpasitions described in the Registration Standard, all
products meeting one of those descriptions would be considered a batch. For
exasple, there would ordinarily have been a batch for products containing only
12.5% sodium hypochlorite and water, another for products containing only 65%
calcium hypochlorite and water, etc. In that there were literally hundreds of
products that net the criteria established in the Registration Standard, these
products have not been listed in the batch tables. Ifte batches in tables I and
II below represent those products which did not meet the specifications of the
1986 Registration Standard
Table I shows 5 batches including 28 products containing the active
ingredient calcium hypochlorite. Note that another 14 products containing the
active ingredient calcium hypochlorite 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 the products
which were not batched are responsible for meeting the acute toxicity data
requirements for each product.
lable I.
Batch
1.
2.
3.
EWl R*S. Ho.
1258-919
10663-45
10663-18
10876-2
1258-915
1258-971
1258-4
1258-1058
1258-1063
1258-106?
1258*1068
1677-145
4829-9
4829-10
4829-90
4829-110
X Calciun Hypochlortt*
2.5
5,0
5.0
2.5
35.0
35.0
50.0
55.0
50.0
50.0
55.0
50,0
50.0
50.0
50.0
50.0
Formulation Typ*
liquid
liquid
liquid
liquid
granular
tabltta
granular
tabtata
granular
tablata
granular
granular
granular
tsbltti
granular
granular
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i
Batch
4.
5.
EPA Reg. No.
1258-1111
1258-1112
1258-1114
1258-1115
125t«1116
1258-1118
1258-1119
12SS-1120
1258-978
1258-979
1258-112!
1258-1122
X Calcium Hypoehlorite
55.0
50.0
54.0
55.0
50.0
55.0
54.0
50.0
62.0
62.0
60,0
60.0
Formulation Type
tablet
tablet
granular
granular
granular
granular
granular
granular
granular
tablets
granular
granular
Table II shows 3 batches including 28 products containing the active
ingredient sodium hypochlorite. Note that another 49 products containing the
active ingredient sodium hypochlorite 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 the products
which were not batched are responsible for meeting the acute toxicity data
requirements for each product.
Table II.
Batch
1.
2.
EP* teg. No,
148-128?
44?- 1
49614-1
57125-4
148-628
1 48-1288
193-16
2686-20001
7546-3
7547-10
18723-1
X Sodium Hypochlorite
5.25
5.25
6.0
6.40
10.5
12.5
12.5
12.5
6.4
12,5
11.6
Formulation Type
liquid
Uqufd
liquid
if quid
Uqufd
Uqufd
Uqufd
Uqufd
Uqufd
Uqufd
Uqufd
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i
Setch
3.
fPA Rtg. No.
264-S12
875-41
875-111
1043*98
1190-14
1677-19
1677-139
446Z-15
5756-37
5991-2
6484-1
8616-12
8898-14
10508-3
10634-2
11741-12
35495-7
X Sodiun Hypochtsrite
3.25
3.25
3.25
3.25
3.25
3.2S
3,25
3.25
3.22
S.25
3.25
3.25
3.75
3,25
3.25
3.25
3.25
Formulation Type
wettabte powder
ponder
powder
powder
powder
powder
powder
wet table powder
wettibte powder
powder
wet table powder
granular
powder
powder
powder
powder
powder
Hie following tables show products 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 III.
EPA Res- No.
475-224
1020-5
1251-91!
1258-1110
1258-1149
1258-1150
1730-56
4829-4
5389-13
5680*5
X calcium hypochlorite
19.5
9.0
60.0
54.0
59.1
59.1
60.0
70.0
0.65
15.0
Formulation type
granular
powder
granular
tablet
tablet
tablet
liquid
granular
liquid
If quid
-------
10876-1
48482-1
48520-7
49592-1
38. 0
69,30
63.6
63,4
liquid
tsblett
granular
Table IV.
EPA R*g. Ho.
402-94
475-21i
491-206
602-168
737-58
1258-726
1S15-2
1317-86
1453-24
1677-51
1706-171
1816-5
2686-1
2792-62
3276-25
3122-21
3573-46
3640-64
4238-25
4313-75
4524-21
4587-2
5736-2
5736-9
5768-9
5813*20
5813-21
5813-23
5813*24
X sodiun hypochtorit*
0.325
2,4
0.4
3.25
0.7
3.25
5.25
8.5
S.25
6.40
8.34
3. 25
3.25
12.5
6.6
6.0
0.5
6.4
8.0
5.25
3.25
12.5
1.94
1.0
3.25
S.25
2.0
0.45
1.65
formulation type
powder
liquid
powder
crystal •
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
w*tt»bl* powder
liquid
liquid
liquid
liquid
liquid
liquid
liquid
wtttiblt powder
liquid
grmuUr
w*tt*bl* powder
wttttblt powder
liquid
liquid
liquid
liquid
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EPA Reg. No.
5813-25
5870-13
5870-17
7350-2
7726-24
9367-37
10183-6
10380-1
17004-3
17705-2
20851-4
34093-4
38623-20002
46183-1
46506-1
47230-1
57125-1
57787-4
59893-3
62207-1
X sodiun hypocMorite
0.7
3.25
1.95
3.25
6.0
10.0
3.09
5.25
5.25
5.25
10.0
10.0
10.0
6.4
0.6
2.5
5.25
10.0
4.5
5.25
Formilation type
liquid
wettable powder
granular
wettable ponder
I iqutd
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
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T
ATTACHMENT E
IPA ACCEPTANCE CRITERIA
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I
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i
SUBDIVISION D
61 Product Identity and Composition 4
62 Analysis tad Certification of Product Ingredients , 6
63 Physical and Chemical Characteristics 8
C-3
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i
Subdivision L
Guideline Ret No. 61
December 24, 1989
61 Product Identity sad Composition
ACCEPTANCE CRITERIA
Does jour study meet the following acceptance criteria?
!• — 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 lexicologically significant impurities (e.g., dioxins,
nitrosamines) present at
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Subdivision D
Guideline Ret Ho. 61
December 24, 1989
61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
Hie following criteria apply to the technical grade of the active ingredient being reregistered. Items 1,
2, 3, and 5 can be satisfied tor most registered products by submission of the Certified Statement of
Formula Ingredient* Page (EPA Form 8570-4). Items ? and 8 can be satisfied for most technical grade
active ingredients (TGAls) by submission of a Bow chart with chemical equations for each intended
chemical reaction. The flow chart should include complete chemical structure* and names for each
reactant and product of all the reactions.
Items in summary should include the items discussed IB Chapter 2 of this package and the specific items
listed below.
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 tipper limit for all impurities present at 1 0.1% and those tendcologicalry significant
impurities present at <(X1%.
4. Hie 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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i
Subdivision L
Guideline Ref. No. 62
December 24, 1989
62 Analysis tod 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 &
Does your study meet the following acceptance criteria?
t _ Five or more representative samples (batches in case of batch process) analyzed for each
active ingredient and all impurities present at j 0.1%
2. ._ Degree of accountability or closure 4 a 98%
3- _ Analyses conducted for certain trace toxic imparities at lower than 0.1% (examples,
nitrosamines in the case of products containing dinitroanilines or containing secondary or
tertiary amines/alkanolamines plus nitrites; polyhalogenated dibenzodiorins and
dibenzofurans) [Note that in the case of nitrosamines both fresh and stored samples must be
analyzed.}
*• __ Complete and detailed description of each step in analytical method used to analyze above
samples
$• __ Statement of precision and accuracy of analytical method used to analyze above samples
6. _ Identities and quantities (including mean and standard deviation) provided for each analyzed
ingredient
7. __ . Upper and lower certified limits proposed for each active ingredient and intentionally added
inert along with explanation of how the limits were determined
8- ___ Upper certified limit proposed for each impurity present at i 0.1% and for certain
lexicologically significant impurities at <0.1% along with explanation of how limit
determined
9. _ Analytical methods to verify certified limits of each active ingredient and impurities (latter
not required if exempt from requirement of tolerance or if generally recognized as safe by
FDA) are fully described
10. _ Analytical methods (as discussed in 4*9) to verify certified limits validated as to their
precision and accuracy
Criteria marked with t * are supplemental and may not be required for every study.
C-6
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Subdivision D
Guideline Ret No. 62
December 24,1989
62 Andys* and Certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active ingredient being reregistered.
*
Items in summary shook! iodode the Item* dtsrmaad in Chapter 2 of this p*dag« and the specific items
listed below.
1. Number of representative sample* analyzed for all active ingredients and ali impurities present at J>
0.1%.
2. Degree of accountability or closure in analyses la item #1.
3, Chemical names of toxic impurities which were analyzed for levels <0-1%.
4, Brief description(s) of analytical method($) used to measure active ingredients and impurities ia
items #1 and #3.
S. Statement of precision and accuracy of method(s) in item 44
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 Unit for each impurity present at >»0.1% and certain toxjcologicalty
significant impurities at <(H% 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 *S if applicable).
C-7
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Subdivision D
Guideline Ref. No. 63
December 24, 1989
63 Physical ant Chemical Ottracteristici
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the foDowinf acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
__ Any intentional coloration also reported in terms of MunseU color system
63-3 Physical State
Verbal description of physical state provided using terms such as 'solid, granular,
volatile liquid*
Based on visual inspection it about 20»2S*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
r_ 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>2S*C
Density of technical grade active ingredient reported in g/ml 91 the specific gravity of
liquids reported with reference to water at 20*C, [Note: Bu|fr density of registered
products may be reported in Ibs/ft1 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 it about 20*2S*C
___ Reported in g/lOOml (other units like ppm acceptable if sparingly soluble)
Criteria marked with a * are supplemental and may not be required for every study.
C-S
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Subdivision O
Guideline Ref. No. 63
December 24, 1989
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*Q
__ Experimental procedure described
__ Reported is 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 Ocunol/witer Panition Coefficient
Measured at about 20>2S*C
Experimentally determined and description of procedure provided (preferred method-
45 Fed. Register 77350)
__ Data lupponing reported value provided
63-12 pH
__ Measured at about 20>2S*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
Criteria marked with a • are supplemental and may not be required for every stody.
C-9
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Subdivision D
Guideline Ret No. 63
December 24, 1989
63 Physical and Chemical Characteristic*
GUIDANCE FOR SUMMARIZINO STUDIES
The following criteria apply to the technical grade of the active ingredient being reregistered.
Items in summary should include toe items discussed In Chapter 2 of this package and the specific items
listed below.
1. Description of color.
1. 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.
?. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant
10. Indication of octanol/water partition coefficient
11. Indication of pH.
11 Description of stability.
C40
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SUBDIVISION F
81-1 Acute Ortl Tosidty la Hit Hit 84
81-2 Acute Dermal Tenacity in tbe Rat, Rabbit or Guinea Pig 86
81-3 Acute Insulation Toiridiy in tbe R« 88
81-4 Primary Eye Irritation in the Rabbit 90
81-5 Primary Dermal Irritation Study 92
81-6 Dermal Seasitizauon in the Guinea Pig 94
81-7 Acute Neuroiojtfcfty in tae Hea %
82-1 Subchronjc Feeding in the Rodent and Nonrodent 98
82-2 Repeated Dose Dermal Toxjdry (21-day) in the Rat, Rabbit or Guinea P1§ 101
82-3 Repeated Dose Dermal Toridty (90-day) in the Rat, Rabbit or Guinea Pig 103
82-4 Subchronjc Inhalation Toridry (90-day) in the Rat 106
82-5 Subchrooic Neurotoridty (90-day) in tne Hen 109
83-1 Chronic Feeding in tne Rodent ane" Nonrodent ill
83-2 Oncogenidty in Rats or Mios 114
83-3 Teratology Studies 117
83-4 Reproduction 119
83-5 Chronic Feeding/Oncogenidty in the Rat 121
84-2 Muugcnidty Studies ..... , . 124
85-1 Metabolism Studia 127
C-83
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Subdivision F
Guideline Ret No. 81-1
December 24, 1989
81-1 Acme Oral Tobdty ia the Bat
ACCEPTANCE CRITERIA
Does jour study meet the toUowinf acceptance criteria?
1. Technical form of the active ingredient tested, (for reregistraiion only)
2.*— At least 5 young adult rats/jex/group
3. ___ Dosing, single oral may be administered over 24 to*.
*•*_— Vehicle control if other than water.
5- .- ^ Doses tested, sufficient to determine a tontity category or a limit dose (5000 mg/kg).
& —. Individual observations at least once a day,
?• -_- Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
S. Individual daity observations.
9.*___ Individual body weights.
10.* Gross necropsy on all
Criteria marked with a * are supplemental and may not be required for every study.
C4*
-------
i
X Subdivision F
Guideline Ret No. Sl-i
December 24, 1989
81-1 Acute Onl Toaddty in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
Items in stuastary should include the items ififr"»fi! ia Chapter 2 of this package and the specific items
listed below.
1. The form of pesticide tested, e.g. solid, liquid, percent Al in technical, etc.
2. The number of aairaals/doseAex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested »nd results
6. Individual observations on day of dosing.
7. Individual observations on day of dosing and for at least 14 days or until all animals appear normal
(whichever is longer).
8. See items 6 and 7
9. Summarization of body weights
10. Summarization of pott necropsy
11. Significance of changes from the Acceptance Criteria
C4S
-------
i
Subdivision
Guideline Ret No, 11-2
December 24, 1989
81-2 Acute Derail Tenacity io the Rat, Rabbit or Goiaea Pig
ACCEPTANCE CRITERIA
Does four stody meet the foOowiiig acceptance criteria?
1- - Technical fonn of the acthc ingredient tested, (for rerepstntioa only)
2." At least 5 animals/sex/group
3.*__ Eats 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 boats.
6.* _. Vehicle control, only if toxicity of vehicle is unknown,
?• x Doses tested, sufficient to determine a tonciiy category or a limit dose (2000 mg/kg),
8. _ Application site clipped or shaved at least 24 hours before (losing
9- —. Application site at least 10% of body surface area.
10* __ Application site covered with a porous nooimtaiing cover to retain test material and to
prevent ingestion.
H> __ Individual observations at least once • day.
12. ____ Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
13. _ Individual daily observations.
14.* Individual body weights.
IS.* Cross necropsy oa all animals.
Criteria marked with a * are supplemental and may not be required for every study.
C-86
-------
Subdivision F
Guideline Ret No, 8i-2
X December 24, 1989
81-2 Acute Dermal Tenacity in tie Rtt, Rabbit or Guinea Pig
OUTDANCE FOR SUMMARIZING STUDIES
Items in summary should indode the items discussed la Chapter 2 of this package and the specific item
listed beiow.
1. The form of pesticide tested, e.§., solid, liquid, percent AI la technical, etc
2. The number of animals/sex/dote
3. Weight range of animals
4 Verification of single, dermal exposure
5. Duration of dermal exposure
6, Statement of vehicle control
7, Doses tested aad results
8. Preparation of application site
9. Area of application lite (percent body surface)
10. Occlusion of test material OB application site
II. Individual observations on day of dosing
11 Individual observations on day of dosing and for at least 14 days or until all animals appear normal
(whichever is longer)
13. See items 11 and 12
14. Summarization of body weights
15. Summarization of gross necropsy
16. Significance of changes from Acceptance Criteria
CS7
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I
Subdivision F
Guideline Ret No. 81-3
December 24, 1989
Sl-3 Acute Inhalation Toxkaty in the Rat
ACCEPTANCE CRITERIA
Does your study meet the IbOowtng tff*p*wg criteria?
1. _ _ Technical form of the active ingredient tested, (for reregmration only)
2- _. Product is a pa, a solid which may produce a significant vapor hazard based on tenacity and
expected us* or conuini panicles of inhalable size for man (aerodynamic diameter IS 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- =r Chamber temperature, 22* C (£2*), relative humidity 40-60%.
?, __„ Monitor rate of air flow
& ____ Monitor actual concentrations of test material to breathing zone.
9. ___ Monitor aerodynamic particle size tot aerosols.
W- — . Doses tested, sufficiem to determine a toxicity catagory or a Unit dose (S mg/L aaual
concentration of respirable substance).
11* — Individual observations at least once a day.
11 ............. Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
*3- — _ ^dividual daily observations.
14.' _ Individual body weigha.
IS.* Cross necropsy on all
Criteria marked with a * are supplemental and may not be required for every study.
CSS
-------
Subdivision F
Guideline Ret No. 81-3
December 24, 1989
il-3 Acute inhalation Tcnddiy ia the Rat
GUIDANCE FOR SUMMARIZING STUDIES
Items ia summary should indude the Item dbconed la Chapter 2 of this package and the specific item
ibtetf below.
%
1, Hie fora of pesticide tested, e.§., solid, liquid, percent A! in technical, etc,
1 Statement of the infallibility of test substance
3. The number of animalsAex/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
& Analytical concentrations of test material in breathing mm
9, Results of aerosol panicle-size determination
10. Doses tested (or limit dot* of Smg/L or highest attainable)
11. Individual observations on day of dosing
12. Individual observations oa day of dosing and for at least 14 days or until all animals appear normal
(whichever is longer)
13. See items 11 and 12
14 Summarization of body weights
IS. Summarization of post necropsy
16. Significance of changes from Acceptance Criteria
C-89
-------
g
Subdivision r
Guideline Ref. No. Sl-4
December 24, 1989
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet ibe foOowiag acceptance criteria?
1. Technical form of the active Ingredient tested, (for ^registration only)
2- ___ Study not required if material is corrosive, causes severe dermal irritation or has a pH of <,
2 or £ IIJ.
3." 6 adult rabbits
4- __ Dosing, instillation into the conjunctiva! sac of one eye per animal
. 5-*___ Dose, 0.1 ml if • liquid; 0.1 ml or not more than 100 nig if a solid, paste or paniculate
substance.
6- _ Solid or granular test material ground to a fine dust
7- —_ Eyes not washed for at least 24 hours.
& :: ^ 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 snorter).
9,* A _ Individual observations for the entire day of dosing.
10.*__ Individual daily observations.
Criteria marked with a * arc supplemental and may not be required for every study.
C-90
-------
i
Subdivision F
Guideline Ref. No, 81-4
December 24, 1989
81-4 Primary Eye Irritation la the RabMt
GUIDANCE FOR SUMMARIZING STUDIES
Items ifl summary should iodade the items discussed IB Chapter 2 of this package and the specific items
listed beta*.
«
1. The form of pesticide tested, eg,, solid, liquid, percent AI in technical, etc.
2. State of material Is corrosive, cause severe dermal irritation or has s pH of <2 or >ll.S
3. Number of adult rabbits tested
4. State method of dosing. It, instillation into the conjunctiva! sac of one eye per animal
5. Dose administered
6. Note whether solid or granular test material has been ground to a fine dust
?. 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 observations for entire day of dosing
10. Individual observations for entire day of dosing and individual daily observations afterwards, until
eyes are normal or for 21 dap
11. Significance of changes from Acceptance Criteria
c-n
-------
i
Subdivisio
Guideline Ref. No. 8i~_
December 24, 1989
81-5 Primary Dermal Irritation Stidy
ACCEPTANCE CRITERIA
Does your study meet the following accepunce criteria?
I- — Technical fora of the active ingredient tested, (for reregistratioi only)
2. _ Study not required if material a corrosive or has a pH of «c 2 or j» 11.S.
3.» 6 adult animals.
4. Dosing, single dermal
5- ___ Dosing duration 4 boms.
& n- Application site shaved or clipped at least 24 hour prior to dosing.
7. Application site approximately 6 on1.
8. __ Application site covered with a gauze patch held in place with aonirritating tape
9- — Material removed, washed, with water, without trauma to application site
10- :r ^ Application site examined aad graded for irritation at 1, 24, 48 and 72 hr, then daily until
normal or 14 days (whichever is shorter).
11.* Individual observations for the entire day of dosing.
12.* _=r Individual daily observations.
Criteria marked with a * art supplemental and may not he required for every study.
C-92
-------
Subdivision F
Guideline Ret Ho. 81-5
December 24,1989
81-5 Primary Dermal Irritation Study
GUIDANCE FOR SUMMARIZING STUDIES
Items ia summary shook*, iodode the item diseased la Chapter 2 of this package tad the specific item
listed below.
1. The form of pesticide tested, eg,, solid, liquid, percent AJ in technical, etc.
2. State if material is corrosive, hai » pH <2 or >11.5, or has a dermal LD-50 <200 ing/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
1 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 entire day of dosing.
12. Individual observations for entire day of dosing and individual daily observations thereafter
13. Significance of changes from Acceptance Criteria.
C-93
-------
Subdivision i
Guideline Ret No. 814
December 24, 1989
81-6 Dermal Semitiatioa in the Guinea Kg
ACCEPTANCE CRITERIA
Does yoor study meet the following acceptance criteria?
1. Technical form of tbe active ingredient tested, (for rercgisintion only)
2. - Study not required if material it corrosive or has a pH of <. 2 or >. 11J.
3. rrr One of the following methods is utilized;
___ Freund's complete adjuvant tett
. __= Guinea pig mwimization test
||||.111JJ|| Split adjuvant tectuuque
___ Buehler test
_ Open epicutueous test
___ Mauer optimization test
___ Footpad lechaique in guinea pig
._ Other test accepted by OECD fspeclfV)
4- __ Complete description of test
S.' Reference for test.
6. _ Test followed essentially as described in reference document.
?.* Positive control included.
Criteria marked with i * are supplemental and may not be required for every study.
C-94
-------
Subdivision F
Guideline Ref. No. 81-6
December 24, 1989
81-6 Dermal Soaittntioa ia cite Guinea Ptf
GUIDANCE FOR SUMMARIZING STUDIES
Item t* summary shooid todade tie item dfaraaed ia Chapter 2 of tab packafe aad the speoflc itetm
listed betow.
1. The fora of pesticide tette4 e.f.. jolld, liquid, percent AI ia »«ehn«fft, etc
2. State if material a corrosft* or kas pH <2 or >HJ).
1. State specific method atOltei
4. Complete deiaiptjoa of spedfle method
5. Reference for the spedfle method employed
& Note adherence of the protocol to thai in the reference for the specific method utilized
7. State the positive control tested
8. Significance of chaafei 600 Acceptance Criteria
C-9S
-------
I
Guideline Ret No. 81-7
December 24, 1989
81-7 Acute Neorotontity ia tae Hea
AOCEPTANCE CRITERIA
Does yow stady meet tae following acceptance criteria?
1. ^ Study performed oa an organophosphaie cholinesterase inhibiting compound.
2. ___ Technical form of the active ingredient tested.
3.* Positive control utilized.
4. . Spedet utilized, domestic laying ben 8-14 months of age.
5. ^ Dosing oral by gavage or capsule (dermal or inhalation may be used).
& _ As *cute oral LDj» *• determined.
7- __ D°** tested equal to an acute oral LD* or a limit tat of 5000 mg/kf.
S.* Dosed aaimtls may be protected with airopme and/or 2-PAM
9- ___ Sufficient test animals so that at least 6 survive.
10. ___ Negative (vehicle) control group of at least 6 hens
II.*„„.,__, Positive control of at least 4 hens, (if used)
12. ___ Test dose repeated if no signs of delayed neuroionciry observed by 21 days after dosing.
13. Observation period 21 days after each dose.
14. ____ Individual daily observations.
13- —— Individual body weigha,
16.* Individual necropsy not required.
I7- , Histopatoology performed on ali animals. Tissue to be fixed in situ preferably using whole
animal perfusion tecaniques. At least three sections of each of toe following tissues:
brain, including medulla oblongau
spinal cord; upper cervical, mid-thoracic and lumbro-sacral regions
tibial nerve; proximal regions and branches
sciatic new
Criteria marked witfe • * an supplemental tad may not be required tot every study.
09*
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I
ATTACHMENT F
LIST OP ALL REGISTRANT(S) SENT THIS DATA CALL-IN NOTIC1
-------
-------
Companies for Cue 0029 NA t CA Hypochtoritc
Printed: 02/10/92 16:21
CO »» CO NAME
000110 MM) I SON CHEMICAL COMPANY, IttC
BOX 125
0001*8 HARCROS CHEMICALS INC.
BOX 2383
000150 ANDERSON CHEMICAL CO.
BOX 10*1
000168 CUE A I UfSrERN CHEMICAL COMPANY
008 S.U. 15TH AVE.
000193 UONDER CHEMICAL CORP
249 CANAL Mt PCNH «AR«R I NO PARK
000228 HVEMtALE CHEMICAL CO
42$ WEST 194TH ST.
000266 MILL BROTHERS CHEMICAL CO.
N. MAIM STREET
0002m MIAMI PtODUCTS t CHEMICAL COMPANY
P.O. BOX 486
000402 HILL MANUFACTURING CO., INC.
BOO JONESBORO *0 Si
000467 BARTON CHEMICAL COHPORAIION
5351 WEST 661 H STREC1
000475 BOYLE MIDWAY
1655 VALLEY m
000491 SELIG CHEMICAL INDUSTRIES THE
840 SET. 1C M SW
000550 VAN IttTERS I ROGERS, INC
801 SECOND AVE, SU11E 1600
000602 PURINA HILLS, IMC.
BOX 66812
000662 BASF CORP
BOX 13528
00074$ PPG INDUSTRIES, INC
ONE PPG HACE
000777 L I F PRODUCTS
225 SUMMIT AVENUE
000813 DPC INDUSTRIES, INC.
300 JACKSON HILL
MADISON IN
KANSAS CUT KS
LITCHfltlO HN
PORTLAND 01
FA1RLESS HILLS PA
CLENWOOO II
ORANGE CA
DAT TON OH
ATLANTA GA
CHICAGO IL
UAMIE NJ
ATLANTA GA
SUBSIDIARY Of UNIVAt
SEATTLE UA
ST LOUIS HO
RESEARCH TRIANCLE PARK NC
PRODUCT SAFETY
PITTSBURGH PA
MONTVALE NJ
HOUSTON TX
47BO
66110
S535S
97205
19010
60*25
92667
4S401
30315
60638
07474
30378
98104
63166
27709
I52T2
07645
77007
-------
SOI to JAME
000831 Aiei C. fERGUSSON, INC
SPRING Hill 01
000875 otvERSEv COUP
1532 RIDDLE AVf ,
000935 OCCIDENTAL CHEMICAL CORPORATION
DEVELOPMENT CENTEI, V 81 BOX 344
001020 MKITE PRODUCTS INC
SO VALLEY ID
001 043 CALGON VESTAL LABORATORIES
•OK 1*7
001072 IMSON BROTHERS CQNPMIT, CHEMICAL
1JS4 ENTERPRISE DRIVE
001190 J.F. DALE? INTERNATIONAL, LTD.
1200 SUITZER AVE
001258 OLIN CORPORATION
BOX 506
001270 IEP HAHOMCTUR1NC COMPMTV
•OX 201S
001317 AN FO ttANUMCIMIHC COMPANY
CLMUOOD AVE. BOX 7311
FRAIER PA
MANDOTTE MI
NIAGARA FALLS NY
•ERIELEY ME IGUIS NJ
DIVISION OF CALGON CORPORATION
ST LOUIS MO
DIVISION
001421 BETIElMCtt CHEMICAL COMPANY
4309 SOUTH MORGAN STREET
001448 BUCKMAN LABS INC
1K6 MCLEAN ItVO
0014S3 PMSCOTt J L COMPANY
16750 SOUTH VICENNES ROW
001553 MOMAR INCORPORATE!!
1830 ELLSUORTH INDUSTRIAL DRIVE
0016/2 JAWS AUSTIN COMPANY
BOX 827
001677 ECOLA8 INC.
370 VWtASNA ST. ECOLAB CENTER
001691 TRUETECH, INC
680«EUON AVENUE
001706 'HAL CO CHEMICAL CO.
ONE HAICO CENTER •
001717 DOONER I SMITH CHEMICAL CO.
374 MALBERRT SJRH1
RONEOVILLE 11
PECKS PRODUCTS DIVISION
ST LOUIS NO
CHESHIRE CT
ATLANTA GA
OAKLAND CA
0
CHICAGO IL
MEMPHIS TN
SOUTH NOUAND IL
ATLANTA GA
MARS PA
SI PAUL MN
RI VERNEAD NY
NAPERVlllE, IL
NEWARK NJ
OiVISlON OF HYSAN CORPORATION
19355
48192
14302
07922
63166
60441
63147
06410
30301
94601
60609
38108
60473
30118
16046
55102
11901
60563
07102
Page 2
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CO p CO NAME
001729 HYBR0TECH CHEMICAL CMP
•Ok 67 OECATUR GA 30031
001730 AMERICAN CYANAMID COMPANY
697 MUTE 46 CLIFTON NJ 07015
001744 JONES CMEN1CALS, INC,
M NUNSON STiEf 1 LEROf VI 14482
001757 OREU INDUSTRIAL DIVISION ASHLAND CNENICAl, INC,
•OX 2219 COLUNMJS OH 43216
001791 SAVOtlTE INC
10*48 E MARGINAL U»T SO, SEATTLE UA 9<1«
00180J CONTINENTAL CNENICAl COMPANY INC
4460 SPUING MOVE AVENUE CINCINNATI OH 45232
001816 1WCO PRODUCTS, INC. SUBSIDIARY Of PENNUALT CORPORATION
7300 WN.SA AVENUE WESTMINSTER CA 92684
0019A4 MEW SOUTH NANUFACTURING COMPANY DIVISION OF HTSAN CORPORATION
4109 SOUTH MORGAN STREET CHICAGO H 6060V
002136 NOffmN, J.L. CO., INC.
MX B6S6 ALLENTOUN PA 1810S
0022JO UAKSAU CHEMICAL COMPANY INC
AftGONNE RD BOX BS8 UARSAU IN 46S80
0024)9 APf>E*SC* CHEMICAL
290S STRICKLAND STREET JACKSONVILLE Ft 12205
002528 ERMICN PRODUCTS COMPANY-FOOD t CHEMICAL PRODUCTS
P.O. KM 55107 INDIANAPOLIS IN 46205
002686 NVmtTE CNENICAl CO.
265$ NORTH NAYFAIR ROAD NILUAUKEE ti! S3226
002792 ATOCNIM NORTH AMERICA
•OX 120 MONROVIA CA 91016
003276 A t I LABORATORIES INC
1001 GlENVOOD AVENUE NINNEAPOIIS NN 55*05
003404 NORTHRUP KING CO.
7SOO OtSON NEMORIAl HWY MINNEAPOLIS NN 55427
005432 N. JONAS i CO., INC.
4520 A/^AMS CIRCLE BOX 425 KNSALEM PA 19020
003522 1USEAUX lAbS IMC
16816 SO GRAHERCY PL. GARDENIA CA 90247
003523 U1IKEM PRODUCIS DIVISION Of OUALCO, INC.
225 PASSA1C SIREEI BOX 557 PASSAIC NJ 07055
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com
003573 THE PROCTER S GAMBLE CO.
6060 CENTER Hltl ROAO CIHCIWMn ON
003635 OXFORD CHEMICALS
PO BOX 80202 ATLANTA GA
001640 STEARNS PACKAGING CORP.
IW 3216 HWISOH Ml
003876 KT2 LABORATORIES, INC.
MM SONERTOM ROAO IMVOSf PA
00407$ JERtT IEE CHEMICAL CO.
MIX 17186 PENSACOLA fl
004166 OOMIHfOM CHEMICAL COMPANY
MM 1069 PETERSBURG V*
0042M DI«MOM) CHEN COWANT
•OX 916 LTMHMST HJ
OM313 CAKBOtl EOMPAMT
2900 W. KIMGSLET frt). GARtAW TX
004462 USC A DIVISION Of HTDRIIE CHEMICAL CO.
2655 MORTM MAYFAIR RD. MILWAUKEE VI
004524 H.8. rULLER COMPANY
J900 JACKSON St., N.E. MINNCAPOLIS NN
004587 HJIPOKT CHEMICAL COMPANY
2029 SOUTH SIM COURT MILWAUKEE Ul
004635 MASTER CHEMICAL COMPANY
642 N TILLAMOOK ST POUT LAW OX
004829 COSTAL INDUSTRIES
235 PASSA1C SHEET PASSAIC HJ
004959 WEST AGRO, INC,
11100 NORTH COMCRESS AVENUE KANSAS CITY MO
005009 PETROL ITE CORPORATION
369 MARSHALL AVENUE ST LOUIS HO
0051B5 110 LABS INC
•OX 1419 DECATUR GA
005389 KAT CHEMICAL COMPANY
BOX 18*07 GREENSBORO NC
005168 rtUBBARD HAIL INC
563 S LEONARD ST UATERWRf CT
0056BO SHEE CHEMICAL COMPANY
1385 TCHOUPITOULAS S». NEU ORLEANS LA
45224
30366
53?04
19053
52522
23804
orori
75041
53226
55421
53207
97227
07055
64153
63119
30031
27419
06708
701JO
Page 4
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CO JR CO NAME
005736 JOE D. SLONE
3630 E KENPER RD
005768 SPURRIER CHEMICAL COMPANIES INC.
MX 2812
005770 THORO PRODS COMPANY
MM 504
005813 CLOROX CO
MX 493
005870 TEXO CORP
2801 HIGHLAND AVE
005991 THEOCNiM LABORATORIES INC
7373 ROUIETT PARK DR
006243 AUTO-CHOR SYSTEM
746 POPLAR AVE
0062*4 RICHEV INDUSTRIES, INC.
•0* 928
006671 GEORGE MANN ft CO., INC.
BOX 9066
006785 P • t S CHEMICAL COMPANY, INC,
RT. 2, HIGHWAY 136 WEST 80X 20
006BJO OCTAGON PROCESS INC
S96 RIVER RD
006931 MERIT CHEMICAL INC
•ON 513
006975 CIEARUAIER DISTRIBUTORS INC
2 ROOSEVELT AVENUE
007116 U.N.X. INC.
•OX 7206
007124 ALDEN LEEDS INC
55 JACOtUS AVE.
007151 ALEXANDER CHEMICAL CORPORATION
KM 248
007267 SAVOL BLEACH COMPANY
433 P^TK AVE.
007299 (HE BRFHCO CORPORATION
U70 S. VANDEVENTER
007350 CHASKA CHEMICAL COMPANY
12502 XEW»OD AVE. SOUTH
AGENT FOB: D06OIS CHEMICALS INC
SHARMVILLE ON
WICHITA KS
ARVADA CO.
PLEASAHTON CA
CINCINNATI ON
AGENT FOR: TIME PtOOOCTS INC
TAMPA FL
MEMPHIS IN
MEDINA OH
PROVIDENCE HI
HENDERSON KY
EBGEUATE* «J
SHMON III
UOODRKKSE NY
GREENVILLE NC
SOUTH KEARNY NJ
LENONT IL
EAST HARTFORD CT
ST LOUIS NO
SAVAGE NN
45241
67201
80002
94566
4521?
33610
58105
44258
02940
42420
07020
535W
12719
27B35
07032
60439
06018
63110
5S378
-------
cojp
007364 GREAT LAKES BIOCHEMICAL CO., INC.
6120 1*51 DOUGLAS AVENUE
007366 fiROH GROUP, IMC.
2501 Ml? AVENUE
007546 U S CHEMICAL
300 H PATRICK BLVD (5JW5)
007547 WESTERN UATER HANACENENT, INC.
IMS IAHCT MK 7469
007616 CHE* LAB PRODUCTS INC
SIM E. AIRPORT DR.
007643 NU UAT PRODUCIS COMPANY
220 GARRISON MX 1508
007675 I IT* I UN CORPORATION OF AMERICA
BOX 795
007726 CHEMMRK INtERNAf HMAL
615 E. CHAPMAN
007870 MAUKINS CNEN INC
3100 E NENNEPIN AVE
007905 LABiCO INCORPORATED
BOX 300016
007*925 THE BR1TE HOUSE CO
1050 U KINZIE sr
OOM3I M1SSO AMERICA IK
220 € 42ND SI SUITE 3002
008154 K 0 K CLEANSER COMPANY
861 CANWN AVE
NIUMUKEE Ul
CUT OF COMMERCE CA
A DIVISION OF HVORIIE CHEMICAL CO.
BROTXFIEIO Wl
NO KANSAS CITY MO
ONTARIO CA
U MEMPHIS AR
BESSEMER CITY »C
ORANGE CA
MINNEAPOLIS MN
HOUSTON TX
51218
90040
51005
64116
91761
72101
28016
92666
5S413
7702J
CHICAGO IL 60622
AGENT FOR; NIPPON SODA CO LTD
NEU TORK NY 10017
COLUMBUS OH 43201
008176 HVC INC
4600 DUES M
008405 IK8CO CHEMICAL CORP
BOX 140
008S17 AMERICAN MACHINERY CORP
PO BOX 3228
CINCINNATI ON
UEBSTEt NA
ORLANDO
45246
01570
12802
008544 GPS INDUSTRIES
13280 A^Ut RO
008576 MATO CNEN CUMPANT INC
5544 OAKDAIE RO '
000571 MOBUL CORPORATION, THE DEXTER CORP.
BOX 200
CITY OF INDUSTRY CA
SMYRNA GA
91746
30082
0/B/A DEXTER UATER MANAGEMENT SYSTEMS Dt
CHAGRIN FALLS OH 44022
Page 6
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CO NR CO NAME
008616 CAVALIER CHEMICAL COMPANY INC
1901 8IH AW
00863? NITCO INC
1601 STEELE A«., SU
008740 PATTERSON IMS INC
11910 PLEASANT A«
000764 MIC CORP
P.O. MK 1708
00878t NEU SALES, INC,
$22 WIT rim STREET
000791 I-I CLOR SYSTEMS
1920 HtTU MAT DRIVE
008821 NOVEL HASH COMPANY INC
•OX 9981
00886* A*CO INDUSTRIES, INC.
4871 HO. 119TN STREET
008871 KLEW MltTE LAB, INC.
ZOO STATE STREET
008898 UITCO CORPORATION1 - $H t EA
155 I ICE BLVD.
008996 SIERRA CHEMICAL COMPANY
2U2 LARK IK CIRCLE
009009 SO WHITE CHEMICAL COMPANY
1075 PLOVER RO.
009157 OLIN CORP
350 KNOTTER OR MX 586
009161 LAIWDRf AIDS INC
333 SIARKE RO
009194 CENTRA! INDUSTRIES INC
40S1 IlKlttM AVENUE
009291 , POOL TML PRODUCTS
221 PASS*1C STREET
009306 INDUSTRIAL SANITATION CONSULTANT
P.O. KM 1037
009336 ALLEN ENGINEtRtNG AND COKSmtJCriON
BOX 613
009359 SURPASS CHEMICAL CO., INC
12S4 BKOADWAV
•ROQKLTN NY
GRAND RAPIDS Ml
DETROIT Ml
tAHELAND fL
UIUIAMMORG PA
ST. LOUIS NO
ST LOUIS MO
NILiHUKEE Ul
IROCKPORT NY
UOODCLIFF LAKE NJ
SPARKS NV
PLOVER HI
CHESHIRE CT
CARLSTADT NJ
ST. LOUIS NO
PASSAIC «J
OANVILLE CA
SERVICE THE
RUTLAND VI
ALBANY NY
11252
49507
48217
33802
16693
A3M4
63122
5322S
14420
07675
89431
54*67
06410
07072
63116
07055
94526
05701
12204
P«t« 7
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CO IH CO MAKE
009167 TMEOCHTM LABORATORIES, INC.
7373 MM.E11 PARK DRIVE
009409 SARATOGA SPECIALTIES
ISO RAILROAD AVENUE
009436 TEXTILE CHEMICAL COMPANY IKC
•OX 11788
00948$ DELTA CHEMICAL CORPORATION
2681 CANNERY AVE
009594 INTECONTINENTAL CHEMICAL CORPORATION
4660 SPRING WOVE AVENUE
009611 IISOM LABS INC
80 LESLIE ST
009616 VERTEX CHEN CMP
MX 3860
009632 ROMAN MELl I COMPANY
•OX 1312
009614 BEL AQUA POOL SUPPLY INC
KG MAIN ST
009743 SKASOL INC
40 CLEVELAND ST
009768 THATCHER COMPANY
KM 27407
009861 TECHNICAL SPECIALTIES CORPORATION
250 ARIZONA., N,E.
01008] AMERICAN DISH SERVICE
10)6 SOUTNUEST BOULEVARD
010098 LIRW'S PRODUCTS INC
1727 CARPENTER ST
010(47 IIRKO CORP08ATION
BOX $30
010182 , ICI AMERICAS INC
NEW mmrm ROAD t CONCORD PIKE
010183 HAVILAHD PRODUCTS CCMPANY
421 ANN^T Wl
010569 ANTECH CHEMICAL CCMPANY Idt
146 S MAIM ST
010380 0-PAK CMP
2H5 NCCAKTER HUT
TAMPA FL
CHEMICALS DIVISIOII
NORTHLAKE II
READING PA
MITINORE MD
CINCINNATI OH
BUffALO NY
ST. LOUIS MO
HARR1SBURG PA
NEU ROCHELLE NY
SAN FRANCISCO CA
SAL1 LAKE CITY UT
ATLANTA GA
KANSAS CITY KS
PHILADELPHIA PA
yESIMIHSTER CO
AGRICULTURAL PRODUCTS
WILMINGTON DE
GRAND RAPIDS HI
MIDDLE TON MA
NEWARK NJ
33610
60164
19612
21226
4S23Z
14211
63122
17105
10805
94105
84127
30307
66103
19146
80030
19897
49504
01949
07104
Page 8
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010*7? BOND CHEMICALS, INC.
1500 laoOKPAM RO
010500 CNEMDTHE CORP
ra tax 171
010998 WORLD INDUSTRIES INTERNATIONAL, INC.
17955 ARENTN AVE.
010613 CifSIAL CHEMICAL I PACKING CONPMT INC
6! VALLEf ST
010634 ALPHA CHEMICAL SERVICES INC
•OX 431
010650 NOHMCM CHEMICALS, INC.
57 MEADOW SI BOX 176
010663 SENfRr CHEMICAL COMPANY
1481 ROCK MOUNTAIN BLVD
010671 SPRINGFIELD HATER CONDITIONING COMPANY
SOX 1306
010876 nilNQAK PRODUCTS
7750 CASTLHMT DR
010897 HASA.1NC.
23119 ORAYTON ST.
011011 ES8RO CHEMICAL
BOX S23
011321 T-CHEN PRODUCTS OIV IHURMONO CHEMICALS
9028 DICE K.
OtUtl LESLIE'S SUINNIHG POOL SUPPLIES INC,
BOX 2108
011611 PUNA CHEMICAL COMPANY
W12-16 so. mm ST.
011736 COLONIAL CMCN1CAL COMPANY
CARRAIIZA RO-RO 3
011741 .OAVIES OW i COMPANY INC
3200 PHILLIPS AVf
012001 Ml STATE POOL SUPPLIES IttC
26 SMITH ;LACE
012014 AtV INC
N62 W22632 VILLAGE DRIV[
012465 ADVANCED IAORATOR1ES
BOX 1368
CLEVELAND OH
MACEDONIA OH
CITY Of INDUSTRY CA
IMKEFIELD MA
SKWGHTON MA
UTICA m
STONE NOUN1AIN GA
INC
INC
SPRINGFIELD MO
DIVISION or HUE LUSTRE/HOME
INDIANAPOLIS IN
SAUGUS CA
REDUDQP CITT CA
C
SANTA FE SPRINGS CA
CNATSUOR1H CA
FORT UORTH TX
V1NCENTOUN NJ
RACINE III
CAMBRIDGE MA
SUSSEX Ul
UESTHELO HA
44109
440S6
91748
01880
02072
13503
30086
65801
CARE PROOUC
462SO
91350
94064
90670
91113
76110
06088
S3403
02138
S3089
01088
-------
COJB CO NAME
015208 UNITE HOUSE CHEM I SPLY COMPANY
455 TRINITY AVENUE
014797 DEltAY CHEMICAL COMPANY, INC.
IMS SU T5TH AVE., SUITE S
015265 WAUSAU CHEMICAL COUP
MK 95J
0168*1 MOH-0-AIB t CLEAN! T CO.
US MERCER STREET
017004 PHILLIPS INDUSTRIAL PROOUCT/OHJSLEY FiElO
Al 1230 HNOLAY STREET
017705 SUPERMARKETS GENERAL CMP
301 HAIR ROAD
017816 CULLY POOL SERVICE I SUPPLY INC
2757 FOUIER SI
018533 ASHLAND CHEMICAL, INC.
BOX 2219
018723 MtOUEST POOL SUPPLY
7607 HURPHir DR BOX 526
019713 OREKEl CHEMICAL COUP ANT
•OX 9306
020474 SYRACUSE POOL CENTER
6176 S BAY *0
020642 CINOT POOLS
U S ROUTE 22
020719 HODGSON POOL SALES INC
58J1 SENECA ST
020051 PUMIEX COMPANY INC 1 HE
6714 UAYNE AVE
021139 LCP CHEMICALS AND LCP TCANSPORTATIOH
SOUTH HOOD AVE Km 4S4
024411 , HATCNICK SUPPLY CO
5260 PORT ROYAL M>
027029 CENTRAL POOL SUPPLY INC
8211 N. ,ULE AVENUE
027581 MIDLAND RESEARCH LAB., INC.
10850 MID AMERICA AVENUE
02B690 POTOMAC CHEMICAL CORPORATION
2916 ANNANDALE RD
TRENTON HJ
OELRAY KACH FL
UAUSAU HI .
•UTLER PA
LAME
CINCINNATI OH
UOODM1KE HI
FT MYERS FL
COLUMBUS OH
HIDDLETON Ul
MEMPHIS TN
CICERO NY
UATCMMG *J
ELNA HI
PEHHSAUKEN NJ
DIVISION Of HANLIN GROUP, INC,
LINDEN NJ
SPRINGFIELD ¥A
PEORIA IL
LENEXA KS
FALLS CHURCH VA
08619
SS444
5U01
16001
4S214
07095
J3901
43216
53562
38109
13039
07060
14059
081 tO
07036
22151
61615
66219
22042
Page 10
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CO HR CO NAME
029*43 TREAT-RITE tMTER LABORATORIES INC
P.O. OHM 151
029728 TWIN COUNT* GROCERS
14$ TALMADtt M>
032196 K.K. STEfl CHEMICALS INC
4313 TRMSHMID W SUITE 250
03M03 GREAT UESTEM CHEMICAL COMPAtH
M8 S.U. 15TH SfREET
033006 HUKIU CHEMICAL CORP.
7013 MICK *D
033458 Ail I tO UHVEISM. CORP.
BJ50 N.W. 93 STREE!
033593 MMZAHL CNEHlUt COMPANY
KACKEKSACK »VE t 380 ST
033871 SOUTNCMGN INC
•OX 1491
033981 K A STEEL CHENICMS INC
4333 TMNSUOtlO ROM)
03*093 SUNSHINE CHEMICAL SPECIALTIES, INC
•OX S40
034J7? ntlllNUH CKH1UI COftPOMTION
201 SUBMHW DRIW MM 1606
034428 THE CNLORANOME CORPORAItaN
PO KK 294 HIVE* M> t IEO Lit* CREEK
034741 IONICS INCatPOIAIEB
65 MOVE
034750 THE OTCHO COHPANT
MX S13
OJ4B59 UATNE CHEMICAL INC.
7114 NOMSrEW MMC
034910 U.KICH CNENICAI. INC
1111 NORTH POST MMD
OJ50B5 UNITE ROX CHEMICAL
SOUTH WjN ST. MX 287
015156 UILNER IMDUS.R1ES INC.
SOX 1265 -
03S25S BAtTIMORE LALWDRT SUPPLIES, INC.
7915 I PHILADELPHIA ftf>
NOIM1A OK
EDISON NJ
KARE CHEMICAL (HV
SCN1LIER PAtK IL
PORTLAND 0*
m,,mm
MIAMI FL
SO KEARNT NJ
DURHAM NC
SCHILLER PARK IL
PfMNSAUCEN NJ
SUFFOLK VA
BELAIMM CITr Of
UATERTOHN NA
NIOTA IN
FORT IMVNE IN
INDIANAPOLIS IN
PHILIIPS8URC «J
NARR1SONHMG VA
BALTIMORE MO
74948
08817
60176
97205
44146
33166
07032
27702
60176
08110
23434
19706
02172
37826
46804
46226
08865
22801
21ZJ7
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coUK co turn
035317 KUfMK CHEMICAL COMPANY, INC
B6 NACKENSACK AVE.
035495 CMENAX
5700 Ml fRONT AVENUE
035911 TOW AW COUNTRY POOLS
3773 E. MORGAN MHD
035934 £ * ( (US) INC
2859 PACES fEftRV ROAD, SUITE 1700
0359*9 AILAHflG POOl MAW., IMC.
40] SOUTH 3RD ST. 'Km 3727
035984 SCOTT SKINNING POOLS, IHC
RT. 47 WASHINGTON ROAD
036022 ACTION CHEMICAL CO INC
1225 S 7TH SI
0361 IS AMCHIOR CORPORATION
9120 tAlBOr AVENUE
036245 SUPERIOR CHEHICAL PRODUCT COMPANY
220 HUraARD ROAD
034288 ALSIP NURSERY
12665 SOUTH CRAUfORO
OSM04 PAZIANOS ASSOC
1338 G ST SE
0)6739 SliTOH SUPPLY CO., INC.
204 E. SAMPLE STREET
036993 fARSON SUPPLY CORPORATION
6071-73 EAST TAfT RD
037062 WECHSLER CONTRACTING CO., INC
MX 333
03743S C. t. POOL SUPPLIES INC
702 COMMERCIAL DRIVE
037557 , MRWR'S CHEMICALS. INC
MX 135
037621 AMERICAN •LEACH NFG CO
1706 POyllAND AVENUE
037655 HORNED EOUIFMENT OF FLA,, IMC
5755 POUERLINE ROAD
OJ7657 J t B POOL SUPPIT
5801 HARGA1E BLVO
SOUTH KEARNV NJ
PORTLAND OR
TPSILANTI Ml
ATLANTA GA
LANTANA FL
iwaoauRT CT
PHOENIX A2
SILVER SPRING ND
07032
97210
48197
30339
33462
06798
85034
20910
TOUKGSTOUN ON
ALSIP IL
44505
60658
ACENT FOR; NISSHO 1UA1 AMERICAN CORP
UASNtNGION DC 20003
SOUTH REND IN
NORTH SYRACUSE NT
HtMTlCELlO m
HOI IV HILl Fl
SHAPPSVILLE PA
LOUISVILLE KY
FT. LAUDEROALE FL
MARGATE Fl
46618
13212
12701
32017
16150
40203
33309
3306]
Page 12
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01?7}1 SUNCQ POOl CO., IMC.
P.O. teat 2186 ma. soi u.
037732 US POOL SERVICE
19265 H.E. (Ill COUtT
017902 ALL-PURE CHEMICAL CO
36700 S. IAH1A M> - Km 26*
018451 C1T2ENS OIL COMPANY, IMC.
377 PINE STREET
03853V IMPERIAL WE SI CHEMICAL CO.,
P.O. MM 496
038542 SUIFI CHEMICAL CO.. IMC.
•OX MO
Q3862I ROBINSON CHEMICAL CO., INC.
KM 264
038699 PAT'S POOl SERVICE. INC.
565* SHIFT MAD
038796 ADIRONDACK CHEMICAL CORP •
222 MAR&AIEI ST SOX 892
038797 NO-CLEAR POOl SERVICE, INC.
242 SOUTH REGENT STREET
038876 PAMPER POOL SERVICE, INC.
30 S.U. STH COU8T
039020 NOVICK CHEMICAL CO., INC.
705 DAVIS STREET
039189 ENVIROCHCN INC.
3U ST. PAUL'S AVENUE
019927 OAOELANO POOL CO., INC.
8680 SU 137 CT.
039924 UNIVERSAL CHEMICALS, INC.
100 HACKENSACK AVCNUE
040137 . PLEASURE INDOSIRIES CORP.
2179 HAiKN IAIN-
040702 CHEMICAL METHODS ASSOCIATES, INC.
12700 K*jU AVENUE
0*0705 IHE UNI TEX CO
155 E, IRAOY ROM
040800 EAGLE CHEMICAL CO.
125 UITMAN ROAD
MYRTLE KACH SC
MIAMI MACK FL
TRACY CA
•URIINCTON VI
ANIIOCH CA
tOCEIS AR
CAMMIOGE MD
SARASOTA fl
PIATISBURGH HY
PORT CHESTER NY
POMPANO REACH FL
SCANTON PA
JERSEY CITY NJ
MIAMI FL
SOUTH KEARNV, NJ
ST. JOSEPH NT
GARDEN GROVE CA
1C!TURNING PA
REAOtNG PA
Z9577
33162
95376
OS401
94509
72756
21613
14231
12901
10573
13060
18505
07306
33183
07032
49085
92641
16201
1960S
13
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COJfi CO NAME
040871 CNEMLAND INC.
KM 2999
0(0975 AtRO DISHUASH1HG SERVICE
3 NORTH 6IH TRAflCUAY
041209 FEDERAL REGULATORY CONSULTANTS INC
204$ N 1STH ST SUITE 108
041211 DX VENTURES, UNITED PARTNERSHIP
BOX 130410
041294 PRIMCETON POOL t PATIO SHOP, INC.
JM ALEXANDER SI.
041391 BURNS CHEMICAL SYSTEMS, INC.
3002 VENTURE COURT
041394 lEAUfV POOtS, INC.
2700 TRANSIT ROAD BOX 41?
041428 SCOTT POOL SERVICE, INC
904 li MAIN ST
041619 E.J. MILLER I SONS POOL COMPANY
RO 4 iOK 208
Ml702 STEELCRETE CO
45700 U 12 MILE »D BOX 636
W1BI1 PARK CORPORATtOi
S11 LAKE ZURICH ROAD
04183? BLUE RIBBON POOLS, INC.
US NIGHUAr 1 t CLINTON ST.
041934 GEORGE S. COYNE CHEMICAL CO. INC
3015 STATE ROAD
041971 NORTH INDUSTRIAL CHEMICALS, INC.
BOX 1904
041995 CINDERELLA INC. KPPC)
1215 S JEFFERSON ST
041997 . OIETZ POO, INC.
9S4 EAS1 GRAND RIVER
042052 BUCKNAHS POOL t SKI SHOP INC
RT 29 Rt 2 BOX 101
042086 aTRAND POOL jERVILf
RD « BOX 3003
042177 YORK CHEMICAL CORPORATION
1309 E CARPENTER FREEU/U
TURLOCC CA
95381
KANSAS CITY KS 66101
AGENT FOR: SOUTH TEXAS CHIOR1NE INC
ARLINGTON VA
DBA OX SYSTEMS COMPANY
HOUSTON TX
PRINCETON NJ
EXPORT PA
WEST SENECA NY
CAMEL IN
Ntm INSURE PA
NOVI HI
BARRINCTOH IL
LINDEN NJ
CROYDON PA
YORK PA
SAGINAW HI
UILIIAMSTON HI
PERKIONENV1LLE PA
STROUDSBURG PA
IRVING IX
22201
77219
08540
15632
14224
46032
17B44
4S37&
60010
07036
19020
17405
48601
48895
18074
18560
75062
Page 14
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042233 SAHMA POOLS lie
RT 22
042608 ED-CHEN CORP.
16 LflSOK HACf t RT. ONE
042613 INDEPENDENT CHEHiCAL CO.
MX 376
042702 PATTERSON LABORATORIES,INC.
119W PLEASANT AVE
042746 NILIE* ALDRIOGE CHEMICAL INC
4255 U »IVMSIDE ST
(HZ895 M INOUSIR1ES IMC
350 MMNT ST«ET SUITE 28
MS1W •EK-CMEN NFC. CORP,
1W DME S£
(M32OT ATLMTIC AQUATICS
P.O. BOX 417
(KJ211 LANE DISTRIIUTIHG CORP
fOOF OF CROPSET AVE
MJ216 J, I, HONBERGER CO, IMC
119 MKMD SI MM 66
(KSJ15 YAROmtE SUPPLY CO.
P.O. BOX 9427
MS410 AGRI-CHEN, INC.
•OX 607477
04J497 PRO CNEHICAIS, INC.
Ml MIME STREET
MS7S9 AKAHA CHEMICAL CO.
545 WEST MAPLET AVE.
043882 NEW IMY CHEMICAL CO.
69 HAMDEN AW.
043922 ' CHEN-MIGHT INDUSTRIES, INC.
12336 EMERSON M
044130 SUN POOLS, SUPPLIES t SERVICES,
?41 RT,,22
INC.
044281 &CREATIONAL FACTORY WAREHOUSE Of ORLANDO
6325 H. ORANGE BLOSSOM ItAll
044282 6ERALP A. JESSE
1105 MAIN ST.
UNITE HOUSE STATION NJ
EOISOH NJ
PITTSTON PA
KTROIT Nl
KANSAS CITY HO
HEU YORK NY
AtBUOUEROUE, NN
OCEAN CUT ND
MOOKLYN NY
SALUNGA PA
TRENTON NJ
ORLANDO FL
OttEN MY M
EL CAJON CA
GUANO CITY, STAIEH ISLAND NY
MIENTON Nl
GREEN BROOK NJ
ORLANDO Fl
SU1H VEIL PRODUCTS
TAYLOR PA
088*9
08817
18640
41217
64150
10280
87105
21842
11224
17538
08650
32860
$4303
92020
10 JO*
48116
08B12
32810
18517
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CO.NR CO NAME
044628 UATERSCIENCE, [DC.
175 MEISTER AVENUE
NATIONAL SAFETY ASSOCIATES, INC
(260 EAST RAINES ROW
04491? VALUE PRODUCTS, INC.
2765 SCOTT UM>,
045(59 i
KM 14867
11 IE UA1ER TECHNOLOGY
0*5225 EIVIROTECH OPERATING SEVICES
5500 HOOCHIN STREET
0*5509 AQUA CLEAR INDUSTRIES, INC.
20 KA1RHES STREET BOX 54JO
045387 SCIENTIFIC UATER SYSTEMS
BOX 52886
045447 CLEHESCO PRODUCTS CORP.
298 COX STREET
0*5458 MtECO INTERNATIONAL INC
BOK 11035
0*5655 HIGH-PO-OIIOR, INC.
BOX 410
045720 SMITH CHEMICAL CORP,
1221 THIRD STREET HE
045983 JET INC.
750 ALPHA DRIVE
0*6181 SAfEUAT INDUSTRIES, INC.
3372 N. HOI ION STREET
046270 IEMOU CHEMICAL PACKAGING INC.
935 EAST HIAIWTHA ILVB.
046372 UATER ENGINEERING SERVICES
22 EAST BUCHANAN STREET
046506 BIONOX CO., INC.
6890 E. LOW DEL MI SON
046554 REACTIVE METALS I ALLOYS CORPORATION
RI 168 ; BOX 366
0*6854 (,.*. GANNON CO., INC.
1134 POST RO.
047033 CASCADE WATER SERVICES INC.
49 •LOOMINGOAIE ROAD
SOMERVILLE NJ
HEHPRIS IN
SANTA CLARA CA
MEMPHIS TH
NAPLES Fl
ALIAHY NY
LAFAYETTE LA
ROSELLE NJ
CINCINNATI ON
CHELSEA MI
CANTON ON
CLEVELAND OH
M1LUMXEE Ul
SYRACUSE «Y
PHOENIX AZ
TUCZO Al
UEST PlIISiURG PA
UARUICK RI
HICKSVIttE W
08876
38118
95050
38114
33942
12205
70505
07203
45211
48118
44704
44143
53212
13206
85004
85715
16160
02BB7
11801
Page 16
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co p cgj*Jg
0472M ENTERPRISE CHEMICAL CO.
12700 KNOT? AVENUE
M7250 MHM iLUe POOLS Of CENTRAL HOR1DA, INC.
11J2 SOUTH PA nut* DR.
047368 NOm LABORATORIES
419 WTO STRUT
048211 INTERCOM CHEMICAL
S647 Kll AVENUE
048226 CHEMICAL POOLS
477 N COURTENAf PKUY BOX 540056
048242 (MM CHEMICAL I SUPPLY
9BJ6 CLAY DO.
048482 EES CORPORATION
12850 MURNEUDOD M
048S20 PHOENIX CHEMICAL CO
8 FAKFIELD COURT
049337 YARITILL POOL SUPPLY
J46T PENMEU RD -RT 452
049592 APPLIED METHODS ENTERPRISES INC
100 SIIMNOT BLVD
049614 CIC EHTERPRIStS
Mi Si OLDtWN PARKUAT
049927 MATE* GUARD, INC.
BOX 2226
050416 PtOCLEAN SYSTEMS IHC
4600 FLAT ROCK ROAD
OS0431 NORTH FLORIDA IMTER TREATMENT, INC.
S87-SAH HARCO AVE.
050510 AUTOTROL CORP.
5730 NORTH GLEN PMtK tOAO
050566 • UEStEY UATEt CHEMICALS
80X 490
0509S6 MR. GEORGE DTCHDALA
68 5HKUET IN
051 OH tfJARD-XITE CHEMICALS INC.
5216 CHAKENCO *
051 IBS MANN POOL CO.
313 II. MAPLE -DT30
GARDEN WOVE CA 92641
SATELLITE MACH FL 3293?
SAN JOSE CA 95125
ST. LOUIS MO 61106
MERRITT IS Fl 12954
HOUSTON IX 77080
AN ELTECH SYSTEMS CO
SUGAR LAND TX 77478
OAN8URY CT 06811
MEDIA PA 1906S
EASTCNESTER NT 10707
LEE'S SUMMIT HO 64061
WILSON K 2789)
PHILADELPHIA PA 19127
ST. AUGUSTINE FL i2084
MILWAUKEE ill 51209
MONIROSE AL 16559
AGENT FOR: SASKATOON CHEMICALS LTD
NORRISTOUN PA 1940S
SOUTH BATE CA 90280
NEU LENOX II 60451
P*fle
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CO N> CO NAHE
05135* G I S ENTERPRISES
8957 E. CENTRA AVENUE
051549 U.S. CHLORINE, INC.
5675 Mf 36TH AVE.
051790 COASTAL CHEMICAL CO.
n GEORGIA PACIFIC WAY SOX 456
052341 ML CHEMICALS, INC,
4620 N. LARKIN M.
052374 SUHIT INDUSTRIES
5702 E. CHANNEL ROAD
052483 H KREVtl UK CO., INC.
BOX
053026 B t • CNLOR1NAT10N CO.
P.O. MX 2*6
05J257 CLCAHUAIEII CHEMICAL CORP.
1575 SUNSHINE OR.
055569 CHEN WEST
8015 DEEDING AVENUE
ENTERPRISE SOLUTIONS
974 EXPLORERS COVE «!24
II CHARD'S HARDWARE
7041 TAH ST.
OS4679 CUSTOM CONTROLS t PUMPS INC
1816 ME 40TH PI
054719 CNA OF OKIO IHCORPOtATEO
1924 CLEVELAND AVE, NU
054998 CAPO INDUSTRIES, LTD.
900 NERTEl AVENUE BOX 209
05*30* (CRUDICO INC.
ym E 4TN
055*87 , B'S POOL SUPPLIES
2081 NELLMAN AVE UNIT J
05571* AQUA SPECIALISTS INC.
160 SILVER PRING RO. BOX iai
055736 (KAIRIE INDtSTRIAL CHEMICALS, INC
BOX 2?19
056005 AOUA CHEMICAL SALES t DELIVERY, INC.
1412 JOLIET RD BOX 609
CARLISLE ON
MIAMI fL
HANPTOM GA
COtflMA CA
45005
33142
30228
91722
DIVISION OF ADVANCE CHEMICAL DISTRIBUTII
CATOOSA OK 74015
NEU HAVEN CT
ALBERT CITT IA
CLEARUAIER Fl
CANOGA PARK CA
ALIAMONTE SPRINGS FL
tWLLTWOOO FL
OCALA FL
CANTON OH
BUFFALO NT
AUBURN IA
ONTARIO CA
NECNANICSBURG PA
UiLLISTON MD
LENONT IL
06S34
505 10
J4625
9130*
32701
33024
32670
44709
14206
51433
91761
17055
58802
60439
Page 18
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0LH CO HAHi
OM138 SAFE -GUARD CHEMICALS CO.
2212 1/Z (mm MICO AVENUE
AQUA SYSTEMS, INC
MM S97
056392 ULTfCH INDUSTRIES INC
•OK 1119
056452 POOL HATER PRODUCTS
17872 MITCHELL HK 17359
OSM1B AMREX CHEMICAL CMP
117 C. FREDERICK SI. BOX 642
D5AS4S CARDINAL CHEMICAL CORP,
MK 24i
056B99 Ml TITANIUM CO - SODIUM PLANT
•Oat 269
057125 THE DIAL CORPORATION
IS 101 (WHIN SCOTTSOALE ROAD
057159 NORTH COUNTRY DAIRY SUPPLY, INC
MX 26
057351 SUNBELT CHEMICALS, INC
71 HARGROVE GRADE
057425 EUGENE P. DEATRICK
101J EAST TAYLOR RUN PARKtMT
057586 KENWOOD POOLS t SPAS
85Z2 NEW FALLS ROAD
057787 NAVILAND CONSUMER PRODUCTS, INC.
1655 TURNER AVENUE, NW
DS7KM DEMY OIL IMRENOUSE OUTLET
2270 OAKLAND DRIVE
058MI MITE NAMUfACTURlMG COMPANY, INC.
1501 ST. LOUIS STREET
059074 SLACK CHEMICAL CO., INC.
MS SO. CLINTON ST
*
059151 WUCHEM CORPORATION
2900 I«.,PENN HIGHWAY BOX S369
05919B flKINC CHEMICAL CO.
BOX 1S9S I
OS92B9 LOCKUOOD LABORAIDJIIES INC.
28JO - 149TH ST
SOUTH ELMONTE CA
ARROYO GUIDE CA
MIDLAND MI
IRVINE CA
IIN6HAM10N HY
LEMONT IL
91731
93*21
48640
92713
13902
60*39
(AN OHIO CORPORATION)
NILES DM
TECHNICAL CENTER
SCOITSOALE AZ
UESTRUTLANO VT
PALM COAST Fl
8525*
05777
12H7
AGENT FOR: CONTROL CHEMICALS (PIT) LTD.
ALEXANDRIA VA 22S02
LEVIITO1M PA
GRAND RAPIDS HI
SYCAMORE IL
NEU ORLEANS LA
CARTHAGE NY
PALMER PA
ROCKFORD IL
HAMMOND IK
19054
49504
60178
70112
13619
18043
61110
46323
Page
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CO.NR
0594Z6 J. JAMES SMULLEN, IMC
SOS EAST MA I It STREET
059625 SEE 10964 CAIIF, OEPT. OF FOOD t A6RI.
1220 N ST
059715 E.S. FIREPLACE STORE, INC,
».D. fB MM 257
059693 COUSTie-GlO INTERNATIONAL, IK.
nil ONUS LAW
060211 HAMII ASSOCIATION OF NURSERYMEN
KM 29i
061428 7C-S SAFETY AND ENVIRONMENTAL CONSULTANTS
5901 WARNER AVI
061602 LAROCHE CHEMICALS INC.
MX 1011
062032 ACCU-CARE SUPPLY. INC.
1190 BROAD ST.
06220? FOX PACKAGING, INC.
SI E NARTLAND AVE
062341 FEDERAL REGULATORY CONSULTANTS, INC
204S N 151H ST SUITE 108
062495 THE EXCELEX CORPORATION
2929 STOREY LANE
062550 ENICNCN AMERICAS INC.
1211 AVENUE Of THE AMERICAS INC.
063231 MAR CREEK PRODUCT ION CO.
tax 2M
063243 NORUM.K UASTEUATER EQUIPMENT CO.
220 REPUBLIC ST.
063404 TIDEWATER INDUSTRIAL CORPORATION
MM 491
063823 MANAGEMENT CONTRACT SERVICES, INC.
BOX 5209
063824 EXSL/UITRA LABS. INC.
176? HA,10NAL AVENUE
065268 ROGERS KK SlfD CO
BOX 1.727
SALISMtT MO
SACRAMENTO CA
KITTANNIIK PA
NINWEAPOtlS MM
HONOtULU Nl
NUHTIN&TON KACN CA
•ATOH ROUGE LA
PROVIDENCE Rl
ST. PAUL m
AGENT FOR: TRINITY MANUFACTURING,
ARLIHCTON VA
DALLAS TX
AGENT FOR: SAMATEC
NEU YORK NT
UASCO CA
NOHMLX OK
GREENSBORO MD
VALDOSTA GA
HAYUARO CA
BOISE ID
INC
21B01
958U
16201
SS4B
96809
92649
70821
02905
SS11?
22201
75220
10036
93280
4485?
21639
31603
9*5*5
83?11
Records printed: 378
P*g« 20
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ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORM FORMS
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?/EPA
United State* Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
form Approved
GUI No, J070-010*
Approval Ezpirc» 12-31-92
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 flll In blanks below.
Company Nam*
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FiFRA). if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of 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):
Mama *f Flrm(»)
Daw *t Offer
Certification:
I certify that > am duly authorized to represent the company named above, and that the statements that I have made on
this form and al attachments therein am true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Compaitv'a Authorized i*pf*«antattva
Dti»
Nam* iftd TIU* (Pf*a«* Typ* or MM)
EPA Form ••7042
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?/EPA
United States Environmental Protection Agency
Washington, DC 20410
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OHI No. 2070-010«
Approval fiplrat 12-Ji-lj
Public r»poning 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 fit) in blanks below.
Company Nun*
Product Name
EPA R«g. No.
1,
I Certify that:
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.
That for each study died in support of registration or ^registration 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 wrting 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)(i)(D) and 3(c)(2}(0) of FiFRA; and (D) Commence
negotiation to determine which data are subject to the compensation requirement of FiFRA and the amount ot
compensation due, » any. The companies I have notified are:
[ ] Hie 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 previousry compied wth section 3(O(1)(0) of FIFRA kx the studies I have cted ft support of
registration or ret egisu atton under FIFRA.
SfgiMlur*
Date
Nam* me Tin* (Pt**M Typ* *r MM)
GENERAL OFFER TO PAY: I hereby ofler and agree to pay compensation to other parsons, with regard to the
registration or ^registration of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D)
Siflnatur*
Data
Nam* and Till* (Pl*aa* Typ* at Print)
EPA Form M70-11 (4-W)
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