United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-7508W)
SEP 30 1992
svEPA Reregistration
Eligibility Document
(RED)
540/RS-93-235
Sodium Hydroxide
-------
#•
-------
REREGISTRATION ELIGIBILITY DOCUMENT
SODIUM HYDROXIDE
LISTD
CASE 4065
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
-------
SODIUM HYDROXIDE REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Gabe Patrick Biological Analysis Branch
Cynthia Szymanski Biological Analysis Branch
James Sauimon Economic Analysis Branch
Fate an^
Division
Richard Lee
Harry Craven
Roy Bingham
Bemice Slutsky
Ecological Effects Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Health Effects Division
Linda Kutney
Pat Mclaughlin
Jim Yowell
William Hazel
Felecia Fort
Chemical Coordination Branch
Toxicology Branch
Occupational and Residential Exposure Branch
Reregistration Support Chemistry Branch
Reregistration Support Chemistry Branch
Registration Division
Amelia Acierto Registration Support Branch
Patricia Critchlow Registration Support Branch
Mary Waller Registration Support Branch
Eugene Wilson Fungicide-Herbicide Branch
Secial Review d
Bruce Sidwell
Carol Stangel
Richard Gebken
Accelerated Reregistration Branch
Policy, Planning and Operations Branch
Accelerated Reregistration Branch
Kennan Garvey Policy and Special Projects Staff
Office of General
Kevin Lee
Office of Cftnipl*afice Monitoring
Beverly Updike
-------
TABLE OF CONTENTS
GLOSSARY OF TERMS AND ABBREVIATIONS iv
EXECUTIVE SUMMARY vi
I. . INTRODUCTION 1
II. CASE OVERVIEW 2
A. Identification of Active Ingredient 2
B. Use Profile 2
C. Regulatory History 3
ffl. SCIENCE ASSESSMENT OF SODIUM HYDROXIDE 4
A. Chemistry Assessment 4
1. Physical Properties of Sodium Hydroxide . .- 4
2. Manufacturing Methods and Non-pesticidal Industrial Uses 5
B. Human Health Assessment 5
1. Acute Toxicity 5
2. Subchronic Toxicity 6
3. Metabolism 6
4. Chronic, Carcinogenicity Studies 6
5. Mutagenicity 6
6. Other Toxicity Information 6
7. Dietary Exposure : 6
8. Occupational and Residential Exposure 7
9. Risk Assessment 7
10. Precautionary Labeling 7
C. Environmental Fate and Ecological Effects Assessment 7
1. Ecological Effects Assessment 8
2. Precautionary Labeling 8
IV. RISK MANAGEMENT AND REREGISTRATION DECISION FOR
SODIUM HYDROXIDE 9
A. Determination of Eligibility 9
V. ACTIONS REQUIRED BY REGISTRANTS OF MANUFACTURING-USE
USE PRODUCTS 10
A. Determination of Eligibility 10
B. Additional Generic Data Requirements IQ
C. Product Specific Data Requirements 10
Labeling Requirements for End-Use Products 11
11
-------
VI. APPENDICES 12
APPENDIX A - Use Patterns Subject to Reregistration
APPENDIX B - Table of the Generic Data Requirements and Studies Used to Make
the Reregistration Decision
APPENDIX C - Citations Considered to be Part of the Data Base Supporting the
Reregistration of sodium hydroxide
APPENDIX D - List of Available Related Documents and PR Notice 91-2
APPENDDC E - Pesticide Reregistration Handbook
APPENDIX F - Generic Data Call-In
Attachment A - Chemical Status Sheet
Attachment B • Generic DCI Response Forms
(Form A) plus Instructions
Attachment C - Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
Attachment D - List of all Registrants) sent this DCI
Attachment E - Cost Share/Data Compensation Forms
APPENDDC G - Product Specific Data Call-In
Attachment A - Chemical Status Sheet
Attachment B - Product Specific DCI Response Forms
(Form A) plus Instructions
Attachment C - Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
Attachment D - List of all Registrant(s) sent this DCI
Attachment E - EPA Acceptance Criteria and PR Notice 86-5
Attachment F - Cost Share/Data Compensation Forms
iii
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FTFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
HDT Highest Dose Tested
LCM 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,
air or feed, e.g., mg/l or ppm.
LDjo 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). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
f-Tg- Lowest Effect Level
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording
and tracking studies submitted.
N/A Not Applicable
IT
-------
GLOSSARY OF TERMS AND ABBREVIATIONS (cont.)
NPDES National Pollutant Discharge Elimination System.
NOEL No Observed Effect Level. Dose level not associated with toxic effects.
OPP Office of Pesticide Programs
ppm Parts Per Million
TD Toxic Dose. The dose at which a substance produces a toxic effect
ug Micro-grams
-------
EXECUTIVE SUMMARY
This Reregistration Eligibility Document (RED) addresses pesticide uses of sodium
hydroxide. Products containing sodium hydroxide are currently registered as herbicides,
fungicides, disinfectants, sanitizers and microbicides/microbiostats (for control of slime-
forming bacteria, fungi and algae). Registered use sites include drinking water systems,
water well casings, food processing plant premises/equipment, food handling areas (in eating
establishments), commercial/institutional/industrial premises, floors and equipment,
hospitals/medical institutional premises and sewage systems. All products containing sodium
hydroxide as an active ingredient and registered for these uses are eligible for reregistration.
The U.S. Environmental Protection Agency (EPA) has conducted a review of the
scientific data bases and other relevant information supporting the reregistration of sodium
hydroxide. All applicable toxicology, human exposure, and ecological and environmental
effect data requirements have been waived for this active ingredient. The information and
data available to the Agency support the conclusion that the currently registered uses of
sodium hydroxide will not result in unreasonable adverse effects to 'human health and the
environment.
Accordingly, the Agency has determined that all products containing sodium
hydroxide as the active ingredient, are eligible for reregistration and will be reregistered
when acceptable labeling and product specific data are submitted and/or cited. Before
reregistering each product, the Agency is requiring that product specific data and revised
labeling be submitted by the registrants within eight months of the issuance of this document.
After reviewing these data, and the revised labels, the Agency will determine whether the
conditions of FIFRA 3(c)(5) have been met, that is, whether product composition and
labeling are acceptable and the product's uses will not cause unreasonable adverse effects to
humans or the environment. If these conditions are met the Agency will reregister the
product. Any end-use products containing sodium hydroxide in combination with other
active ingredients will not be reregistered until REDs are issued for all active ingredients
contained in that product.
-------
I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) was
amended to accelerate the rcregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the rercgistration process to
be completed in nine years. There are five phases to the reregistration process. The first
four phases of the process focus on the 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.
FIFRA Section 4(g)(2)(A) states that in Phase 5, "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration." 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 FEFRA.
This document presents the Agency's decision regarding the reregistration of sodium
hydroxide. The document consists of six sections. Section I is the introduction. Section n
describes sodium hydroxide, its uses, data requirements and regulatory history. Section ffl
discusses the human health and environmental assessment based on the data available to the
Agency. Section IV discusses the reregistration decision for sodium hydroxide. Section V
covers actions required by registrants of manufacturing-use and end-use products. Section VI
contains the appendices which support this Reregistration Eligibility Document. Additional
details concerning the Agency's review of applicable data are available on request.1
1EPA'S reviews of data on the set of registered uses considered for EPA's analysis may
be obtained from the OPP Public docket, Field Operations Division (H7506C), Office of
Pesticide Programs, EPA, Washington, DC 20460.
-------
H. CASE OVERVIEW
A. Identification of Active Ingredient
1. Chemical Name: Sodium Hydroxide
2. CAS Number: 1310-73-2
3. Office of Pesticide Programs Chemical Code Number: 076503
4. Empirical Formula: NaOH
B. Use Profile
1. Type of Pesticide: Herbicide; fungicide; disinfectant;
fungicide/fungistat; sanitizer; microbicide/microbistat (slime-forming bacteria,
fungi, and algae).
2. Pests Controlled: tree roots, fungi, bacteria (unspecified), and
slime-forming bacteria, fungi, and algae.
-------
UieSto
Indoor Food: Humnn
Drinking Water Sytiem*
(water well cuinf); Food
Procejiing Ptmt Premiiea
(Non-food contact); Food
ProceMing Flat
Equipment (Food
contact); Eating
EitaMiihmraU Fond
Handling Aim (Food
•ad Non-food contact).
Indoor Mon-faod*
Commercial/
faTfftyftrcHl/fjylfcMtpai
Pl'Til'liiTT fiqlllpmCQt
(Indoor).
lodoor Non-food:
• CommerciaiflniriMinnaM
nduarial Fkwn
f Aiif""!**] • 4«j*i« oAfy).
Indoor Medical:
Hospilaia/Medieal
inititutioiii preoiiKs
• (Human/Veterinary);
Hotpitab/Mcdkil
conductive Floor*.
A
Equipment
Mop,
-------
Sodium hydroxide-containing products were initially registered in 1951. The
seven currently registered products are used as herbicides, fungicides, disinfectants,
sanitizers, microbicide/microbiostats. The Food and Drug Administration, in 21 CFR
184.1763, lists sodium hydroxide as a substance generally recognized as safe (GRAS)
for use in food. The listing includes uses as a pH control agent and as a processing
aid, with no limitations other than current good manufacturing practice.
Under a memorandum of understanding issued on December 22, 1971, (36 FR
24234), FDA and the Agency defined responsibilities in the regulation of food-contact
sanitizing solutions. FDA approves, under food additive regulations, the use of
sanitizers on food-contact surfaces. The Agency defers to FDA for dietary risk
assessments. This approval includes the lexicological and dietary residue
assessments. The Agency focuses on product chemistry, efficacy and applicator risk
assessments. Sodium hydroxide containing products registered as sanitizers for food-
contact surfaces fall under this agreement. Therefore, for this reregistration
assessment of sodium hydroxide, the Agency has not conducted a risk assessment
associated with the food-contact surface sanitizer uses. Rather, the Agency defers to
FDA's assessment and clearance.
SCIENCE ASSESSMENT OF SODIUM HYDROXIDE
The Agency has reviewed the scientific data base for sodium hydroxide.
Information considered is primarily from published literature. These are cited in
Appendix C.
A. Chemistry Assessment
1. Physical Properties of Sodium Hydroxide
Sodium Hydroxide is a white, crystalline, brittle solid. For laboratory
purposes, it is ordinarily sold in the form of sticks, pellets or white flakes. It
is often called caustic soda. As this name indicates, it is a corrosive substance
and has a strong disintegrating action upon both animal and vegetable tissues.
It is extremely soluble in water and a great deal of heat is liberated during
solution. When exposed to the air, it absorbs both moisture and carbon
dioxide and is changed into sodium carbonate. Its solution has a soapy feel
and a strong cleansing action.
Sotubilization results in immediate dissociation into sodium and
hydroxide ions to the following equation: NaOH - Na+ + OH'. The pH
values of unbuffered water containing sodium hydroxide from 0.1 to 10,000
parts per million (ppm) range from 8.4 to 13.4, respectively.
-------
2. Manufacturing Methods and Non-pesticidal Industrial Uses
The primary source of sodium hydroxide is by the electrolysis of
sodium chloride solutions, which also yields chlorine as a secondary product
during manufacturing. Also sodium hydroxide may be produced by reacting
calcium hydroxide with sodium carbonate. 0> *'
Sodium hydroxide is used in many chemical industries. Its major
industrial uses are in the rayon, film and chemical industries. It is also used
by soap manufacturers, petroleum refineries, textile producers and pulp and
paper manufacturers.(1>
B. Human Health Assessment
The toxicological data base on sodium hydroxide is adequate and will support
reregistration. Sodium hydroxide is a widely-used chemical and the toxicity has been
known generally for some time.
1. Acute Toxicity
TABLE OF ACUTE TOXICTTY DATA FOR SODIUM HYDROXIDE:
TEST RESULT
Acute Oral Lethal Dose-Rabbit
Eye Irritation
Skin Irritation
Acute Dermal Toxicity
Acute Inhalation Toxicity
(mg/kg)
500
Corrosive
Corrosive
TOXICITY
CATEGORY
n
I
I
Corrosive
Sodium hydroxide is corrosive and irritating to skin, eyes and mucous
membranes °- *>. The oral lethal dose for rabbits is reported to be 500 mg/kg(!> M.
Corrosion of gastric mucosa and perforation of the stomach wall were found in
rabbits given 5 to 12 g/kg of sodium hydroxide in milk<3).
A solution of 5 percent sodium hydroxide in water produced severe necrosis
on rabbit skin when applied for 4 hours ®. The application of 50 ug of sodium
hydroxide to rabbit eyes for 24 hours caused severe irritation 0).
-------
2. Subchronic Toritity
When rats were exposed to an aerosol of 40 percent sodium hydroxide
for 30 minutes twice a week, two of 10 rats died after 3 weeks, with bronchial
ulceration and lung effects m.
3. Metabolism
Free alkalis, such as sodium hydroxide, are convened to neutral salts
by the acids in the stomach 0).
4. Chronic, Carcinogenichy Studies
In an experiment in painting sodium hydroxide on the skin of mice,
carcinogenicity was not found ®\ Mice given sodium hydroxide by mouth for
10 months, equivalent to 200 mg/kg, did not show carcinogenicity in the
digestive system (3). No adverse effects were found in rats receiving 1 mg/kg
by gavage three times a week for 93 days (3).
5. Mutagenicity
Tests with £L coli strain Sd-4 did not indicate mutagenic activity with
sodium hydroxide <3).
6. Other Toricrty Information
From observations of accidental and intentional human poisoning cases,
it has been estimated that the fatal dose of sodium hydroxide is less than 10 g
(3). In non-fatal cases of ingestion, sodium hydroxide was found to cause
severe esopnageal stricture m. Skin from human volunteers, where IN
sodium hydroxide had been applied for 15-180 minutes, showed progressive
changes from cell dissolution in the homy layer, through edema, to total
destruction of the epidermis (2).
7. Dietary Exposure
There are no direct pesticidal food uses for sodium hydroxide.
However, products containing sodium hydroxide are registered for use on
food contact surfaces and well-head casings. These applications have been
assessed by FDA memorandum of understanding discussed above in section
n. C., Regulatory History.
-------
8. Occupational and Residential Exposure
Sodium hydroxide is formulated in soluble concentrates and dry
flowables containing 1.05-98.5% sodium hydroxide combined with one or
more of the following active ingredients: copper sulfate, sodium chloride,
sodium metasilicate, sodium carbonate, trisodium phosphate, sodium
dodecylbenzenesulfonate, sodium dichloro-s-triazinetrione,
2,6-dichlorobenzonitrile, alkyl (68%C,2, 32%C14) dimethyl ethylbenzyl
ammonium chloride and alkyl (60%C14, 30%C16, 5%CIS, 5%CJ2) dimethyl
benzyl ammonium chloride. These mixtures are applied undiluted, or diluted
with water by pouring into drains or spraying water dilutions on surface sites.
9.
Risk Assessment
There is no reason to expect that all current usage of sodium
hydroxide as a pesticide, with appropriate precautions, will constitute any
unreasonable hazard from ordinary exposure.
Sodium hydroxide is corrosive and irritating to skin, eyes, and mucous
membranes and has a moderate acute oral toxicity. Based on the application
methods and formulation types for products containing sodium hydroxide, the
potential for significant eye and dermal exposure to mixers, loaders, and
applicators in commercial and institutional settings exists. However, providing
the products are used in accordance with appropriate label precautions for eye
and dermal protection, the potential worker exposure should be minimal. For
the food contact surface uses, the Agency defers to FDA and their acceptance
of risks associated with these uses.
10. Precautionary Labeling
Based on the application methods and formulation types, the potential
for significant eye and dermal exposure to mixers, loaders, and applicators in
commercial and institutional settings exists. Appropriate label precautions for
eye and skin protection are required since sodium hydroxide is corrosive.
Refer to Section V. D., Labeling Requirements for End-Use Products below
for more details.
C. Environmental Fate and Ecological Effects Assessment
There are no outstanding environmental fate data requirements for the uses
since there is sufficient information in the public literature on the fate of sodium
hydroxide in the environment. See Section m.A., Chemistry Assessment, above for
more details.
-------
The use of sodium hydroxide in sewage systems is also regulated by
state regulatory agencies, through a National Pollutant Discharge Elimination
System (NPDES) permit for environmental discharges, the Agency did not
conduct a risk assessment for this current use. Compliance with the National
pollutant Discharge Elimination System (NPDES) permit is required for sewer
treatment. In many instances, the ultimate destination of the effluent from the
sewer drain is the local sewage treatment plant. In the unlikely event that the
waste in the sewer line would have a higher pH due to the addition of sodium
hydroxide, the sewage treatment plant would be required to adjust the pH of
the total effluent to be in compliance with a NPDES permit. The Agency has
determined that bioassays on fish and aquatic invertebrates conducted under
standardized test conditions, including buffered water, would yield LCjo/ECj0
values greater than 1 ppm. Therefore, no environmental precautions
pertaining to aquatic toxicity statement would be required. No further data are
needed for product labeling for these uses.
The risk for using products containing sodium hydroxide on well-head
casings to control slime would occur at the time that the treated water is
discharged. In addition to the varied buffering capacity of different waters,
the initial pH in the well water is unpredictable. However, use instructions
require a minimum holding time period of 24 hours, during which the pH may
decrease. In addition, exposure to terrestrial organisms such as birds and
mammals to the discharged water would be expected to be small and of short
duration.
2. Precautionary Labeling
a. For manufacturing-use products and end use products for
controlling roots in sanitary sewer lines, the Agency requires a label
statement about these products' toxicity to wildlife and the requirement
for a NPDES permit prior to discharge. [Residential use is exempt
from this requirement.] Refer to Section V. D., Labeling Requirements
for End-Use Products, below for specific labeling.
b. For end-use products for use on well-head casings the Agency
requires label statements concerning wildlife toxicity and a prohibition
against contamination of water by disposal of equipment, wash-water,
or rinsate. Refer to Section V. D., Labelng Requirements for End-Use
Products, below for specific labeling.
8
-------
IV. RISK MANAGEMENT AND REREGISTRATION DECISION FOR
SODIUM HYDROXIDE
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing sodium hydroxide are eligible for rercgistration. The Agency has waived
submission of all generic data requirements except basic product identity and
chemistry. The Agency has completed its review of all available information, and has
determined that the data are sufficient to support reregistration of products containing
sodium hydroxide. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of sodium
hydroxide and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to
assess registered uses of sodium hydroxide and to determine that these uses can be
used without resulting hi unreasonable adverse effects to humans and the environment.
While the Agency lacks certain chemistry data to support the purity of each technical
source of sodium hydroxide, it has no reason to suspect any source contains impurity
of concern. Nevertheless, the Agency is requiring such data to confirm this. Refer
to Section VI., B., below for these data requirements. The Agency therefore finds
that products containing sodium hydroxide as an active ingredient are eligible for
reregistration. The reregistration of particular products is addressed in Section V of
this document
Although the Agency has found that certain products containing sodium
hydroxide are eligible for reregistration, it should be understood that the Agency may
take appropriate regulatory action, and/or require the submission of additional data to
support the registration of products containing sodium hydroxide, if new information
comes to the Agency's attention or if the data requirements for reregistration (or the
guidelines for generating such data) change.
-------
V. ACTIONS REQUIRED BY REGISTRANTS OF MANUFACTURING-USE USE
PRODUCTS
A. Determination of Eligibility
1. Based on the Agency's reviews of the generic data base for the active
ingredient sodium hydroxide, the products containing this active ingredient are eligible
for reregistration. Section 4(g)(2)(B) of FDFRA calls for the Agency to obtain any
needed product-specific data and revised product labels, 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.
B. Additional Generic Data Requirements
The generic data base supporting the reregistration of products containing
sodium hydroxide has been reviewed and determined to be sufficiently complete to
allow the Agency to reach its decision of reregistration eligibility. The following
generic data for sodium hydroxide have not been submitted and are required to
confirm the manufacturing process(es) and impurities of each technical grade source
used in registered products. These data are due to the Agency within eight months of
[start clock same as product specific data requirements]. The Agency will include its
review of these data in its decision whether to reregister individual products.
° All available technical specifications, data sheets and other documents by
which the manufacturer, producer or supplier describes the composition
information.
o A description of the manufacturing process(es) for all sources of sodium
hydroxide used in all registered products.
o A discussion of any impurities present for all technical sources of sodium
hydroxide.
^
C. Product Specific Data Requirements
The Agency is waiving all the acute toxicity data requirements for the end-use
products, because of the corrosive characteristics of the chemical, and shall rely on
the toxicity categories established for the active ingredient. To characterize the
product chemistry and efficacy of individual products, the Agency is requiring the
product-specific data requirements stated in Attachment F.
10
-------
D. Labeling Requirements for End-Use Products
The labeling of all products must comply with the Agency's current
regulations and requirements as specified in 40 CFR 156.10. Follow the instructions
in the Product Reregistration Handbook with respect to labels and labeling.
Additionally the following precautionary statements are required.
1. Precautionary Labeling
For manufacturing-use and end-use products for controlling roots in
sanitary sewer lines:
a. This pesticide is toxic to wildlife. 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 a NPDES permit. Do not discharge effluent containing this product
to sewer systems without previously notifying the sewage plant
authority. For guidance contact your State Water Board or Regional
office of the U. S. Environmental Protection Agency. [Residential use
is exempt from this requirement.]
b. For end-use products for use on well-head casings the Agency
requires label statements concerning wildlife toxicity and prohibition
against contamination of water by disposal of equipment, wash water,
or rinsate.
c. Additionally for all end-use products:
The Agency is requiring the following label statement on end-use
products to mitigate the potential for irreversible eye tissue damage:
"When using this product, wear eye goggles or safety glasses". The
Agency may impose additional product specific pre-cautions and
requirements for eye and dermal protection when product-specific data
has been submitted and reviewed and determined to be acceptable.
11
-------
VI. APPENDICES
-------
APPENDIX A - Use Patterns Subject to Reregistration
-------
"iT
x
0
•o
X
1
w
m
O
_o
O
O)
%
»
(0
(0
A
5
o
c
i
•i
IO
§
x
S
i
lit
I1!
if
3 3
I'l
1
i
l
j j j i
**J
uj
i
ii
j'
j
j
j
i
i
i
j
I
i
1
(A
2
3D/FEED U
£
1
i
o
5
mant (Food Contact)
Ul
]
1
Praclaan.
Remova, protect
food product* and
packaging materiala.
Potable water rinse.
i
z
i
z
z
i
i
i
s
*
E • S
3*1 .
1 T
|||
S "
8
1
s
I
1
j
III
Praclean.
Remova, protect
food productB and
packaging material*.
Potafala water rinae.
Z
Z
O
1
O
Z
z
i
3
i
o
S 9
E . 8
!»•§
«*•
^ ^
s •
u
m
on Labal, Sponga
i
I
j
Ul
Preclean.
Remove, protect
food product* and
packaging materials.
Potable water rinse.
J
z
d
Q.
€
Z
z
i
z
i
i
^
^ 0
« £
s
E * «
•^ ^ *c
1*1
s ?
I5l
S *
t
on Label, Sprayer
I
I
i
ILI
I
aaa Uaa Group*: Indoo
1
|
1
Praclean. i
Remove, protect II
food product* and II
packaging material*. II
Potabia water rinse. ||
Z
z
u
i
z
Z
o
0
S.
I
> 9
E • 8
* "5 TS
E * 8
a. "o •£
s'i
^ —
1;!
0 J>
§
1
i.
w
s
^
£
*
1
u.
i
1
o
«
5
S
£
i
1
a
j
•2
-------
"o
X
E
1
«
S
10
0
"3
i2
O
o»
S
I
in
5
X
5
i
14
11 !
1
]H i
111
jii ^
J
••1
11
•t
1
Ii
j
J
1
,
1
,
1
i
Praclaan.
Remove, protect
food products and
packaging materials.
Potable watar rinee.
•
I
z
z
o
1
i
i
i
1 64 ppm by
Vol.
(disinfect)
£ -s
ill
s *
s
i
1
s
1
1
i
s
8
E
*
Preclean.
Remove, protect
food product* and
packaging malarial*.
Potabia watar rinse.
Z
3
8
8-
i
z
d
i
i
i
i
164 ppm by
Vol.
(disinfect)
S ?
ii!
* i
$
f .
&
}
§
|
t!
|
E
£
I
•i
5
8
a
u
|
1
•B
1
fl
iS
?
1
Precleen.
Remove, protect
food products and
packaging material*.
Potable watar rime.
•
z
i
i •
z
u
1
d
i
I
1 64 ppm by
Vol.
(disinfect)
> _
•o 1"
o i
8
1
|
§
I
|
t
w
Preclean. 1
Remove, protect 1
food product* and II
packaging matariaJ*. II
Potabia water rinee. |]
Z
Z
o
Z
J
0.
i
8
o
1 64 ppm by
Vol.
(disinfect)
* ?
3
i
1
1
§
i
^
I
s
s
r
"
Preclaan.
Remove, protect
food product* and
packaging material*.
Potabia watar rinaa.
Z
Z
8
S-
z
z
1
u
i
o
8
2-
z
1 64 ppm by
Vol.
(diiinfect)
S
-------
5
i
•o
.2
09
3
to
in
U
"3
I
i'i
in
sill
sm
a-S » i
* o £ *
5 s ft •
S a « 3
III!
i
s I
1
«nJ
11 ? i
B *| ?*
: s ii^
•§ i-o.s-8
« e X o S
l£°ZZ
1 ?
Praclaan.
Ramova, pr
• 2 'c
2 I S
3 E S
^gS
I"
III
i
s *
u a E -c
IIU
a- ?S
Pracl
Ram
food
pack
Potabi
i
i
i
Dri
Pump tha fjrat
after traatman
wasta.
apac.
Related Su
on Label
1 s
ill
s -
1
i
A •£
c • ^
||^
**> •=
i
s *
Sp
-------
0
S
3
E
m
o
o
I
1
i(
l]
II
i'!
i
i
»
11
II
j
I
1
Ui
*
i
ine
in
e
£
-
I
l-l
Ml
: I
1
i
* 3
S i
by
a)
ppm
66
Vol
(••ni
?
Vol.
ntoct)
1
o
I
I
66 ppm by
Vol.
(MritiZO)
i
l
64 ppm by
Vol.
(dirinfect)
66 pom by
Vot.
(Mnitiz*)
64 ppm by
Vol.
(diunfaetl
1
0
1
1 «
H
S 2
by
a)
Vol.
Scrub
64 p
Vo
(disin
t. Not on
-------
O
1
2
E
o
75
n i
il ,
!
-------
s
i
•o
ID
O
a
j
s!
ti
In
i
i
I{.
i
1
I
I
1
••j
Hi
i
i
u>
1
I*
i
Ib Al per
apac.
I
i Hills
i
i
Doaa cannot
be calculated
i
Doae cannot
be calculated
s
!
«
$
i
1
o
£
n
a
*3
f.
II!
ii
i
! <
I « <
iiU
ill
Z u. 1C
'i
&
I
D
-------
APPENDIX B
Table of the Generic Data Requirements and
Studies Used to Make the Reregistration Decision
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for sodium
hydroxide covered by this Reregistration Eligibility document. It contains generic data requirements that
apply to sodium hydroxide in all products, including data requirements for which a "typical formulation" i
the test substance.
The data table is organized in the following format:
1. Data Requirement (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 se
in the Pesticide assessment Guidelines, which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2: Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical.
O Indoor residential
3, Bibliographic frfot""1 (Column 3). If the Agency has acceptable data in its files, this colum
lists the identifying number of each study. This normally is the Master Record Identification (MRID)
number, but may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography
appendix for a complete citation of the study.
-------
K2
1!
fife
iu
$•$5-33
555555
>'.
X al
8 *e
g &§5
QC
1
I
T3
«9
I
VI
i
I
I
1
&
QO
W"i
I
g
U
?
1
"S
»
i
-------
B
.5
ao
I
i
-------
APPENDIX C
Citations Considered to be Part of the Data Base Supporting the
Reregistration of Sodium Hydroxide
-------
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregistration Eligibility Document. Primary sources for studies in this bibliography
have been the body of data submitted to EPA and its predecessor agencies in support of past
regulatory decisions. Selections from other sources including the published literature, in
those instances where they have been considered, are included.
2.UNTTS OF ENTRY. The unit of entry in this bibliography is called a "study." In the
case of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single subject),
can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
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 whenever a specific reference is required. It is not
related to the six-digit "Accession Number" that has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. Besides the Master Record Identifier (MRID), each entry has a
citation containing standard elements followed, by material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect
the standard of the American National Standards Institute (ANSI), expanded to
provide special needs.
a. Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no author
or laboratory could be identified, the Agency has shown the first submitter as the
author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced the date
from the evidence contained in the document. When the date appears as (19??), the
Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or tnhancf 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:
Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the earliest
known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit accession
number follows the symbol "CDL", which stands for "Company Data
Library." This accession number is in turn followed by an alphabetic suffix,
which shows the relative position of the study within the volume.
BIBLIOGRAPHY
(1) Sax, N. I., and Lewis, R. J. SR, 1989. Dangerous Properties of Industrial
Materials, 7th Edition. Van Nostrand Reinhold, New York.
(2) Clayton, G. D., and Clayton, F. E., eds., 1982. Patty's Industrial Hygiene and
Toxicology, 3rd. Revised Edition. Wiley Interscience, NY.
(3) FASEB, 1976. "Evaluation of the Health Aspects of Sodium Hydroxide and
Potassium Hydroxide as Food Ingredients." SCOGS-85.
(4) Windholz, M., Budavari, S., Blumetti, R., and Otterbein, E., Eds., 1983. "The
Merck Index." Merck & Co., Inc.
-------
APPENDIX D
List of Available Related Documents and PR Notice 91-2
-------
UNTTID STATIS ENVIRONMINTAL PROTECTION AOJNCY
WASMNOTON, D.C.
Ml mOTTCB SI* 9 OffClOP
********* »* • MCTCBCiAIBTI
WMTANCtS
NOTICE TO MANUFACTURERS, PRODUCERS, FORMBLATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
Z. PURPOSE:
Tha purpose of this notica la to clarify tha Of flea • of
Pesticide Program'* policy with respsct to the stateaent of
percentages in a pesticide's label's ingradiant statement.
Specifically, the anount (parcant by vaigbt) of ingradiant(a)
apacifiad in tha ingradiant atataaant en tha labal Bust ba atatad
a» tha noainal concantration of such ingradiant (a), aa that tarm is
dafinad la 40 cm 151.153 (i). Accordingly, tha Agancy has
aatAbliahad tha noainal concantration as tha only accaptabla labal
claia for tha aaeunt of activa ingradiant in tha product.
.XX. BACKGROUND
For seas tiaa tha Agancy has accaptad two dif f arant aathods of
identifying on tha latoal what parcantaga is claiaad for tha
ingredient (s) contained in a peaticida. SOBS applicants claiaed a
parcantags which raprasantad * level between tha uppsr snd tha
lowar certified liaita. . This was referred to aa tha noainal
concentration. Other applicants, claiaed tha lowar liait as tha
percentage of tha ingredient (a) that would be expected to be
present la their product at the end of the product *s shelf-life.
Unfortunately, this Isd to a groat deal of confusion aaong the
regulated industry, the regulators, and the conauaers as to exactly
how auca of a given ingredient was in a given product. The Agency
has established tha noainal eoncantrstion as tha only acceptable
labal clai» for tha aaount of activa Ingredient in tha product.
Current regulations require that tha percentage listed in tha
activa ingredient stateaent be as precise as possible reflecting
good manufacturing practices 40 CFR 156.10(g) (9). Tha certified
linits required for aach activa ingredient ara intended to
sneoapass any such "good manufacturing practice" variations 40 CFR
15«.175(c)(3).
-------
2.
The upper and lover certified liaita, which muat be proposed in
connection with a product'* regiatration, repreaent the amounta of
an ingredient that may legally ba praaant 40 CFR 158.175. The lever
certified limit ia uaed aa the enforceable lover limit for the
product coapoaition according to FZFRA aection 12(a)(l)(C), while
the nominal concentration appearing on the label vould be the
routinely achieved concentration uaed for calculation of deaagea
and dilution*.
The noainal concentration vould in fact atate the greateat
degree of accuracy that ia warranted with reapect to actual product
coapoaition beeauae the noainal concentration veuld be the amount
of active ingredient typically found in the product.
It ia important for regiatranta to note that certified limite
for active ingredienta are not conaidered to be trade aecret,
information under FZFRA aection 10(b). Zn thia reapect the
certified limita will be routinely provided by IPX to Statea -for
enforceaent purpoaea, aince the noainal concentration appearing on
the label aay not repreaent the enforceable coapeaition for
purpoaea of aection l2(a)(l)(C).
ZZZ. REQUIREMENTS
Aa deacribed below under Unit V. • CQMPLXAHCB SCKttOtt,* all*
currently regiatared produeta aa vail aa all application* for new
regiatration auat comply with thia Hotica by apecifying the noainal
concentration expreaaed aa a percentage by weight aa the label
claim in the ingredient (a) atataaent and equivalence atatamenta if
applicable (e.g., eleaental areanie, aetallie ainc, aalt of an*
acid). Zn addition* the requirement for performing aample analyaea
of five or aore rapreaentative aaaplea auat be fulfilled. Cepiea of
the raw analytical data auat be aubaitted with the noainal
ingredient label elaia. Further information about the analyaia
requirement may be found in the 40 CFR 13*. 170. All product* are
required to provide certified limit* for each active, inert
Ingredient, iapurltiea of toxicologieal *ignificanca(i.«.f upper
liait (a) only) and en a caae by caaa baaia a* apecified by IPA.
Thea* limit* are to be *et baaed on repreaentative aampling and
chemical analyaia(i.e., quality control) of the product.
••
The format of the ingredient *tatement muat conform] to 40 CFR
156-Labeling Xaquiraaant* For Peaticide* and Devicea.
After July 1, 1997, all peaticide ingr%di*nt atatemanta muat
be changed to nominal concentration*
-------
.3
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are reguired to be efficacious. Therefore,
the certified lover limits may not be lover then the minimum
level to achieve efficacy. This is extremely important for
products vhich are intended to control peats vhich thraeten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 151.640.
In those cases vhere efficacy limits have been established,
the Agency vill not accept certified lover limits vhich ara belov
that level for the shelf life of'the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
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 reguirements of this notice as
smoothly as possible so es not to disrupt or delay the Agency's
high priority programs, i.e., roregistration, nev chemical, or
fast track (FIFRA section 9(c)(3)(B). Therefore,
applicants/registrants ara expected to coaply vith tha
requirements of this Notice as follovat
(1) Beginning July 1, 1991, all nav product
registrations submitted to tha Agency
ara to coaply vith the reguirements of this
Notica.
(2) Registrants having products subject to
reregistration under FIFRA section 4 (a) ara to
coaply vith the reguirements of this Notiea vhen
specific products ara called in by tha Agency
under Phase V of tha Reregistration Program.
(3) All other products/applications that ara
not subject to (1) and (2) above vill hava until
July 1, 1997, to comply vita this Notiea.
Such applieationa should note ^Conversion
to Nominal Concentration" on tha application
fox*. These types of amendments vill not be
handled as 'Fast Track* applieationa but
vill be handled as routine regueats.
VI. FOX FUKKEX DfFORKATION
Contact Tyrone Aikan for information or questions concerning
this notice on (703) 337-3024.
Anna I. Lindsay, Director
Registration Division (H-7303
-------
List of Available Related Documents
The following is a list of available documents related to sodium hydroxide. Its
purpose is to provide a path to more detailed information if it is needed. These
accompanying documents are part of the Administrative Record for sodium hydroxide and
are included in the EPA's Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Sodium hydroxide RED Fact Sheet
4. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
-------
APPENDIX E
Pesticide Reregistration Handbook
-------
APPENDIX F
Generic Data Call-In
-------
Attachment A
Chemical Status Sheet
-------
SODIUM HYDROXIDE: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s) containing
sodium hydroxide.
This Generic Pflfa fall-In Chemical States Sheet, contains an overview of data required by
this notice, and point of contact for inquiries pertaining to the reregistration of sodium
hydroxide. This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment B), (3) the Requirements
Status and Registrant's Form (Attachment C), (4) a list of registrants receiving this DO
(Attachment D), (5) the EPA Acceptance Criteria (Attachment E), and (6) the Cost Share and
Data Compensation Forms in replying to this Sodium Hydroxide Generic Data Call-In
(Attachment F). Instructions and guidance accompany each form.
DATA
By THIS NOTICE
The additional data requirements needed to complete the generic database for sodium
hydroxide are contained in the Requirements Status and Registrant's. 'Response. Attachment
C. The Agency has concluded that additional product chemistry data on sodium hydroxide
are needed. These data are needed to fully complete the reregistration of all products
containing sodium hydroxide.
INQUIRIES ANP RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures established
by this Notice, please contact Richard Gebken at (703) 308-8591. .
All responses to this Notice for the generic data requirements should be submitted to:
Richard J. Gebken, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: SODIUM HYDROXIDE
-------
Attachment B
Generic DCI Response Forms (Form A) plus Instructions
-------
c
o
•H
O O
Ss
oi „
IS
•H rf
«« I
*0 A
2
4J
0
+J
W
•d
o>
43
•H
D
IS
t S
|i
Crt tl
= s
S
•s
I u
i" M
M>
i w
I o
0
14
4J
to
to
0)
(0
0)
Ifl
o
'.I1
* ifl •= 5
1
o
-*
*€
1S
1«
SS
'"'S
*fi
i
O
o
in
!i
1?
!i
i| :
«"S- ^
«l s
S S Ii i
fi i|l I
-------
••
O
t-i
«
0
19
R.
I
i
o m
_ 5 £
I S I
O O UJ
K • "m
* S S
S. i 1
o
c
0
*
c
al Protectioi
.C. 20460
RESPONSE
•P Q g
i c 2
° -8 d
H &• y
*? C
|| g
(0 * *§
(0
CO
*o
•H
B
£
•2
•S
£
S
1
}
4*
I
S
JC
£
1
w
^
1
+*
I
«;
•
I
15
*fc
5
1
U
&
a
.M
TRUCTIOMS: please type or print In im
additional sheet(s) If necessary
M •
23
„
S
*
^ U
"5 S
• §
S o
^
o.
o
u
w
0
to
<0 **J
XI 0
VO
rH in
< « and Name
65 Minera
lical » and Name 07
!um hydroxide
3° ll
U ~ U M
IM
.
H
.^ O
^•2
i^.H
Company name and Address 007'
KING OF ALL MANUFACTUR
2601 DAVISON RD
FLINT MI, 48506
«
£
o
*••
!
1
^
3
1
«
| |.
!i«Is
!il|t
Z^ S* a
y s • v a!
o o ?^^ •
xjsifi
• S*|fj|
K- b<»Ma(
C • Bl
*l!h
j|il!
5 O C S ^«
1. *. |— jj •
^Illli
* B o ** •»
r» >» b<^ in ae
°"8
*z *< «
e u?
^» '* w
M •} 8 M tt
6b. 1 agree to satl
Data requirements <
on the attached foi
"Requirements Stati
Registrant's ftespoi
» l.i
g-|'|5
!? t-s
•^ ^ **
- Is.
il^il
•ttl]
• *» *< 9 •
• • J} b !•
•oo o>» *>
s.|s
• v'fl « —
c 8 • i-
• * i «- a
in o o>« **
*I
-'-
CO
1
^
I
o
•
. 1"
"i
"S.«
RT
rue, accurate, and c<
ishable by fine, Impi
** §
ll,
a
P
«c **
gg £
?I 5
— - ** «v
"» I
I-? S
i! 1
O M at
~«* 1
— • «_ M
Certification
ertify that the statements made on th
cknouledge that any knowingly false o
both under applicable law.
nature and Title of Company's Author!
U • O)
« * 5
b
1
*
1
^
Name of Conpany Contact
o
-------
D
*
£
I
u
01
*
g
o
l»
,1
« I 2
(0
0)
e
9
1
I
5
i
ll
!
g
IS
1 ^
S
I
(D
(0
•»*-- -
g 5II 5
Z S«b -D
• f mtt c
u **"v "B •
£ >— S «
— — O VI
-------
«
D
is
u
O
0 N
.2 w
g|
"> -H
M
to ^
IB
W
•o
0)
D
I
i
I
1
1
= i
^•5
I. C
o
II
I!
il
il
ii
s
•s
I H
S w
2 o
J
•P
a
a
«n
So .
H Ifl
it! r-
14 O
tt '«
C f
a ™S
o
^
!H w -
|°5
?w &
n
«
*|si;
(Hill
-JcP-2
IS-
J!ii;
-S8ES8
4-1 o f 5
IJMS
-:ns
• w CD
4 • e £ «
Zo 5 i «
•*
•Hi
ss
O)
A
«
*
"i
IS
** 5
"J!
| 2
cS
k ** C ** M
s slf |
a _ ~ o w
-------
V
O
^H
*J
8S |
l« 1
* S
H -3
• £
« *
*J
I
Sta
!
i
i
= s
h. j
II
i
I o
•B Aj
I 3
§
h
n
0)
10
ffj n
£ o
vo
•H m
o
o
to
\o
OH
I* "* s
tf in p
IH iHffa
% "i-
"*5S Si
-SeffS
— er —
*•*! 8_ »
• ••*• • Q.
"?-p«8
S|l.«
j,5s?.-
-i-is
??•££
-fc5a«
»i;h
IcZSi-
•~^||
TJ|. «|
•!:i§
"22S«
££*££>
.
!i
|j
|1
!r
;i i
Ii i
O • oc
:^ i
U I
X
k
• «.=
.COO. M
** =
S 5
r=!s 2
a s** |
• ——• O M
-------
o
H
SL
cH
i!
* »
O ill
o S
* s
11
°
« to
to 5
u *
4*
(0
4J
CO
1
S
ii
i
i!
to
w
(0 n
A 0
tfl
0)
I
l
!
i :
S i
o w
0 *P
N M
55
**
ft^ii.
D • *• w •
,5*i«
L-lH
O C *•
"*
•J
•>**•«*'
«*•;»
III
*!«•
JJ g. 2
zs
o
o
o
H
M
i*
i
•- * «
B a —
o *^
if i
il !
:• i
^•1. N
s° •:
S- I
I4 *
!! I
|I^ I
rl^
* 8 u
•£•!• ~
••* I s
<•- x—
-------
(who, with respect to the incorporated product, are in compliance with this and any other
outstanding Data Call-In Notice), and incorporate that product into all your products, you
may complete this item for all products listed on this form. If, however, you produce the
active ingredient yourself, or use any unregistered product (regardless of the fact that some
of your sources are registered), you may not claim a Generic Data Exemption and you may
not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated in Item 3 and
if you are agreeing to satisfy the generic data requirements of this data call-in. Attach the
Requirements States and Registrant's Response Form, that indicates how you will satisfy
those requirements.
Item 7a. Check this item if this call-in is a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing use product for
which you agree to supply product-specific data. Attach the Requirements Status and
Registrants' Response Form that indicates how you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP) as
indicated in Item 3 and if your product is a end use product for which you agree to supply
product-specific data. Attach the Requirements Status and Reqistrant's Response Form that
indicates how you will satisfy those requirements.
Item 8. This certification statement must be signed by an authorized representative of your
company and the person signing must include his/her title. Additional pages used in your
response must be initialled and dated in the space provided for the certification.
Item 9. Enter the date of signature.
Item 10. Enter die name of the person EPA should contact with questions regarding your
response.
Item 11. Enter the phone number of your company contact.
-------
Attachment C
Product Specific Requirement Status and Registrants' Response Forms
(Form B) plus Instructions and PR Notice 86-5
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WAJHIN6TON. O-C. 204*0
JUL29
PR
•*-«
•rrtcf
- INDEX -
A. Organisation of the Submittal Package ........ 3
B. Transmittal Document ................ 4
C. individual Studies 4
C.I Special Considerations for Identifying Studies. . 5
D. Organisation of each Study Volume . . . 6
D.I studv Tin- »•—
1?
11
17
Whan a single study is extremely long, binding it in multiple
volumes is permissible so long as th* entire 4tu4y in pa^inaf}^
..-; * £ir.vi« misi.'i**t ana «awn volume is plainly identified by the
study title and its position in the nulti*volune sequence.
C.I Special Considerations for Identifying studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety studies. Several Guidelines require testing for
safety in more than one species. In th«**. ««•* ••«•*« *•»•«•«-•
-------
D.2. Statement* of Data Confidentiality Claims Under FIFRA SlO(d)U).
Each submitted study must be accompanied by one of the two
alternative forms of the Statement of Data Confidentiality Claims
specified in the proposed regulation in $158.33 (b) and (e).
(See Attachment 3) These statements apply only to claims of data
confidentiality based on FIFRA SlCMdMl) (ATTTB), or (C). Use
the appropriate alternative fora of the statement either to
assert a claim of $10(d)(l) data confidentiality <«158.33(b))
or to waive such a claim ($158.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with petitions
for tolerances or emergency exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
If the claift is made that a study includes confidential busi-
ness information as defined by the criteria of FIFRA $10(d)(lUA),
(B), or (C) (as described in D.2. above) all such information must
be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so
isolated must be identified by a reference number cited within the •
•body of the study at the point from which the passage was excised
(See Attachment 5).
The Confidential Attachment to a study must be identified by a
coyer sheet fully identifying the parent study, and must be clearly
marked 'Confidential Attachment.* An appropriately annotated
photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the
body of the study, beginning with page 1 of X on the title page.
Each passage confined to the Confidential Attachment must be assoc-
iated with a specific cross reference to the page(s) in the main
body of the study on which it is cited, and with a reference to the
applicable passage(s) of FIFRA $10(d)(l) on which the confidentiality
claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4}
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA S10(d)
(1HA), (B), or (C), the following provisions applyi
* The specific information to which the claim applies must be
clearly marked in the body of the study as'subject to a
claim of confidentiality.
- A Supplemental statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
* The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include tne typed name
and title of the official who signed it.
8
-------
t'.S Crrd Laf--.ratr>ry Practice Compliance Statement
This statement it required if the study contains laboratory
work subject to CLP requirements specified in 40 CPR 160. Sam-
ples of these statements are shown in Attachment 6*
E. Reference to Previously Submitted Data
00 NOT RESUBXIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the NRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies should not be included in the transmit-
tal document* but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must-be on uniform
8 1/2 by 11 inch white paper, printed on one side only in black
ink, with high contrast and good resolution. Bindings for indi-
vidual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the. following pointst
o Do not include frayed or torn pages.
o Do not include carbon copies, or copies in other than
black ink.
o Make sure that photocopies are clear, complete, and fully
readable.
o Do not include oversize computer printouts or fold-out pages.
e Do not bind any documents with glue or binding tapes.
o Make cure that all pages of each study, including any attach-
ments or appendices, are present and in correct sequence.
Number of Copies Required - All submittal*packages except
£
those associated with a Registration Standard or Special Review
(see Part C below) must be provided in three complete, identical
copies. (The proposed regulations specified two copies; three
are now being required .'to expedite and reduce the cost of proces-
sing data into the OPP Pesticide Document Management System and
getting it into review.)
-------
C* Special Requirements for Submitting Datato the Docket
Data submittal packages associated witn a fc*gi»tration Scan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been""exeised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
o Remove the 'Supplemental Statement of Data Confidentiality
Claims'.
o Remove the 'Confidential Attachment*.
o Excise from the body of the study any information you claim
as confidential, even if it does not fall within the scope
of FIFRA $10(d)(l)(A), (B), or (C). Do not close up or
paraphrase text remaining after this excision.
.o Mark the fourth copy plainly on both its cover and its title
page with the phrase "Public Docket Material - contains no
information claimed as confidential".
V. For Further t •> format ion
For further information contact William C. Grosse, Chief,
Information Services Branch, Program Management and Support
Division, (703-557-2613).
ames W, Akerman
cting Director,
Registration Division
Attachment 1.
Attachment 2.
Attachment 3,
Attachment 4.
Attachment 5.
Attachment 6.
Attachment 7.
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Subaittal Packages and studies
10
-------
ATTACHMENT 1.
CLEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
!• Name and address of submitter (or all joint submitters**)
fSmith Chemical Corporation Jones Chemical Company
1234 west Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
*Smith Chemical Corp. will act as sole agent for all submitters.
2. Regulatory action in support ct which this package is submitted
Use the EPA identification number (e.g. 359-EUP-67) if you
know it Otherwise describe the type of request (e.g. experi-
mental use permit, data call-in - of xx-xx-xx date).
• »
3. Transmittal date
4. List of submitted studies
vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers,, and so forth.
vol 2. Title of first study in the submittal (Guideline No.)
•
• «
^ •
Vol n. Title of nth study in the submittal (Guideline No.)
* Applicants commonly provide this information in a trans-
mittal letter. This remains an acceptable practice so
long as all four elements are included.
•* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter con-
cerning data compensation or subsequent use or release
of tKe data.
Company Officials
Company Names
Company Contacts
Name
Signature
Name
Phone
11
-------
ATTACHMENT 2.
SAMPLE STUDY TITLE PACE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John c. Devis
Study Completed On
January 5* 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
• ,
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages fn the study)
-------
JCTWMBCr 3.
STATWDJTS Of MIA CONFIDENTIALm CLAMS
- 1. No claim of confidentiality under riFFA SlD(d)(l)(A),(B), or (C)
SIM-WENT OF NO DATA COKFIIfNTIALm CLAIMS
No claire of confidentiality ia made for any information contained in this st-jrty
on the basis of its filling within the scope of FIFRA flO(d)(l)(A), (B), or (C).
Oanpany
Company Agents
Typed N»ne
Titla
Gates
Signature
2. Claim of confidentiality undar FIFPA $10(d)(l)(A>, (B), or (C).
OP QKEA OOMriDD«riALm CLAIMS
*•*••
Information clainad confidential on tha basis of its falling within tha scope
of FIFRA $10(d)(l)(A), (B), or (C) has baan ranovwd to « confidential appendix,
and is cited by cross-reference ruifcer in tha body of the study.
Conpanyt
Ccnpany Agent*
Typed
Title
Date:
Signature
NOIEi Applicants for permanent or temporary tolerances should note that it
is on policy that no permanent tolerance, temporary tolerance, or request for
an emergency exanption incorporatir^ an analytical method, can be approved
unless the applicant waives all claims of confidentiality for the analytical
method. These analytical nethods are published in the FDA Festicide Analyt-
ical Methods Manual* and therefore cannot be claimed as confidential. OPP
implements this policy by returning submitted analytical mthods, for tfcich
which confidentiality elatas have been naua, to the submitter* to obtain
the confidentiality waiver before they can be processed.
-------
ATTACHMENT 4.
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
for any portion of a submitted study that it not described
by FIFRA SlO(dHlHA), (B), or (C), but for which you claim
confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claiast
o Identify specifically by page and line number(si each
portion of the study for which you claim confidentiality.
*o Cite the reasons why the cited passage qualifies for
confidential treatment.
o indicate the length of tine--until a specific date or
event* or permanently--for which the information should
be treated as confidential.
o Identify the measures taken to guard against undesired
disclosure of this information.
o Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
o Enclose copies of any pertinent determinations of confi-
dentiality made by EPA, other Federal agencies, or courts
concerning this information.
•
p If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why they
should be viewed as substantial.
o If you assert that the information is voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
14
-------
5.
EXAMPLES OP SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1 (Confidential word or phrase that has bMn deleted froti the study)
CROSS REFERENCE NUMBER 1
TED IGRDS OR PHRASE i
this erots reference number it used in the study
in place of the following words or phrase at the
indicated volume and page references.
Ethvlene Glvcol
REASON
6 14
26 25
100 19
Identity of Inert Ingredient
Example 2 (Confidential paraoraph(s) that have been deleted from the study)
OOSS.ICFERDCE NUMBER
DELEBD'»EAGRAPH(S) t
This cross reference runber is used in the study
in place of the following paragraph(s) at the
indicated volune and page references.
Reproduce the deleted paragraph(s) here
PAflE-JIMES REASON FOR TOE DELETION FIFRA REFERENCE
20 4-T7 Description of the quality control process SlO(d)UHC)
3 {Confidential paces that have been deleted from the study)
NUMBER 7 Ihis cross reference nunber noted on a place-holder
page is used in place of the following whole pages
at the indicated volume and page references.
DELggDHCE(8y» are attached innediately behind this page.
REASON FOR THE DELCTICM
Description of product manufacturing process
HFRA REFERENCE
flO(d)UMA)
IS
-------
ATTACH"r>T 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1,
This study meets the requirements for 40 CFR Part 160
Submitter •
.. Sponsor . •
Study Director
Example 2.
This study does not meet the requirements of 4C CPR
Part 160* and differs in the following wayss
1.
2.
3.
Submitter
Sponsor
Study Director
Example 3*
The submitter of this study was neither the sponsor of this
study nor conducted it* and does not know whether it has
been conducted in accordance with 40 CFR Part 160.
Submitter '
16
-------
ATTACHMENT 7.
FORMAT OP THE SUBMITTAL PACKAGE
Trsnamittal Document.
LEGEND
-*^
Administrative Materials
(e.g., Method of Support Statement, etc.)
Other Materials about the submittal
-------
H
«H
O
i-l
g
ID
On
*?
° 2
5 5
I* i
*; i
ig i
c §
« o
< a
c S
al Protect!
.C. 20460
EQISTRANT'B
^j f\ £K
e °
O u
M "& a
1-S |
rt J3 ^
Ql i^
W i* ^
a
4J H
(0 52
i i
i i
i
m
2
*<
E
}
i
£
1
£
&
y
i
1
1
I
•*
•
i
^*
y
£
•
it
I
S
5
^
i
i|
w ?
ft **
M
ll
I!
ii
*
o
*£ S
•< M
• C3
,
w
C
o
(0 * andMaM
65 Mineral
nical « and Nana '
iui hydroxide
S ° J TJ
rg
0
O
in
o
Q
O
in
as CM
o 10
M O
11 &
!!si
Ills
*
i
— S
fl!3
•
>- 1
«&
s
£
^2
sj
m
2.
6 *•
MO ^
u F
.~» ^..^
|
M*
8-
Hi
•«oex
,
'
.
'
«
01 01 Q
§O Q
e e
P«C*W
«-»*•+!-(
_
III
i-t i-TH
rtj flj (8
•^
4'
a **
di
5
ill
* * *
H**rT
H t-t H
^0 .^A ^ft
j
«
^
.«
ft «
« i
l|
'A
j.2.
w X
I"
«|
• i $
^^ 1
KTJ S
el 1
en «
•! ?
|l !
1 1
I^JS *
• B u ^
iliil
5 „«• * *•
a « * k v
w <*"» £
t. — Of 3
tf ** C ** +*
" go* |
k
2
_
C
£
*
n
|
&
*s
rj
-------
H
«M
O
^j
^1
0
§
&
>i
g
C
0
D»
< a
» 0 §
0 ID Q
** «* 8
2 s 1
& N g
•
Is ° H
I- 1
g - S
I C 0
S° 1
•HE1 8
^ -H a!
«« g
(R
" a «
0zg
4J S
to 5
JB
•o R
5 .
•H *
c
D
g1
0
h 0
x> «n
CO -H
x
- O
U I*
S S
5 *
H §
10 t-H
fclS
I C-a W
12?
* :s s
* w 8 •• to i.
ill «l *
1!" -S8 2g 1
4*O -O 14 SO 14
-.(04J 0 Q, S 45
i2*J- M »o a
i M
"5^ .SS .
ij«e ^tjsss s
00A .!•> a Oh TJ
H 13 U (H QtJS *H 0
T|-H 0 « 3 0+* S -H
0«jA C *» 0 CT J3 IB «H <8 "O
0 JJ ID xl rS
> *> PH*^ W15 . "
H.n ««w c o-o 0
f»«> g o o-rt-H 0 .S
ISi2B Ti--'H'Q
W H CC'O-H-H +>
[ • iH J5O0hkl ID
0CO 10 0-Hr-J 30 3
•o m o 0 *j H ES i
ID rH-H JJ Q, O 0
fc C «H i4 0 T> 0>
U CC JC 0h4>J3 Q) •
fa O £UC4>0 -H ^.
•-400 4J tfl 0 A 4J h
•H* 0 0 0 rH 3-0
C T3 3 0 C+> 3 D ffl
£0£ 4J-O O 0
*» e TJ o « 3 «w«
06 T3 BJ J5-O O U
0 C-
O *H «H I0.0.C kl C
3 TJ 3 Ll 4J ,0 C.C * "
^Mh 00 o+J oeo
•H 0 O -H J3 C-H 4) in
W43 X -P (0 4Jftf
E O 0 AUfiLOC Cb
04JA B-H-na^ 00
O*^ d) ft fj o jj «*j ^
0 C J3 tfl 545 5
C-H "O XI C 0 (0 j« «W 43 ft fl C
CO O ki 0 x» g S
0 O .-. 0 J3 O C
O b< ^"O x) x> O O «.
C*tO x>fio 45|v
3 O •HOl7<0xi xl vo
5^^ ^0^sg . a-
2-S5 ^ 0 >t> I04JO CcO
IF^^r? *O«H a co vo o in
•- rt"^2y -H4JH-O-HH IHH
• locgc ^>UH |3o
ID 2"
•• w cT
A A
'U> «0
-------
e "H S
1*4 U^ B'
•* (0 ^^
W X
Q> * 0
jj |«
0 as
*§ 1
V O
•H O
§ 1
1
i
s
|
s
1
1
i
^
t~*
I
id Instructiont
i
8
1
-
i
i
z
i
13
*i
fe «
^rf
1*
il
— «•>
ii
II
*
Is
»- M
"8 S
lo
w
f
(0 (*>
Q S
10 in
o
and Naw
Mineral
il ff and Haw
hydroxide
:|{j
~
N
*^ .
O ^
O
H
£
rg^S
Sas in
d000
ifaSa
H£
1 SB OH
a
**
I
!|
— *
«i
l|
K!
is
IO
w **
II"
-— >-W_TT-
.
|
in
i|
!i
•*0
|8
si $
"c * *
•5 ? S
11 i
i* i
I? \
*h I
44 «rf
a xjb «^-
4^ C IB O
M 8 U
i *ii s
llfl 1
U (• iM O IP
tt U J3 C
|
|
£
si
1
s
I
*»•
o
CM
-------
I
+> n
0O 0tt|
td P *<*•
•0 M so
00* a
M _ no
O4J-5 0
* Oh
«M ar-H
0 0)4J 3
c*» o o«
g--s
O 09
H « .
««w c o-o
o O-H-H 0
-H
0 -p H a o
** ao 0
•H h 0 «O
0 M4JJ3
J3 O C*» 0
4J CO O A
0 O C
0,o CJB
IB 0 O 4J
•^fi C-H
fc 4J O4J0*J
*J CIM C
C 0-H «o 0 -H i-l
« U»H 10 •
-------
«"4
o
I
a> S
£ *
2s
1"
§ c
c 2
H •§
to
United
I
x
I
INSTRUCTIONS:
Use additional
o
1
a
a m
« o
ni u^
-------
«H C O
O-H-H
o 0 c a*>
4J-O O O
•O O 0 3
o
•HX C-H
04J
0 -H-H 0
4>.J34* W
o ao c
•P h U
•H O O»04J
0 O iH 10
0-H C 3 C CO
x 0-H o o m
t» ^-^»
-------
V
0
&
!
•o
a
g
2
I
g
I
i
i
I
ii
il
R •
= 5
2
n n
0) o
ta vo
A in
•Or*.
o
S C -o 2
i^?l
o>
N
A
O
O
-i
t£
m
E
§
s >,
*,
w'c* PI
355
*-^e^- 1-
ffl «3 «J
1"* 5
ill
H « CM
1 1 1
•H Hr-4
i
!?!l
Sf e Q. *•
^ -*» c
£ S... -g
Ji 5f I 1
S >JS .
-------
-3*.''. ifeaSSi.M'.w.- frsSiwsrr-.
.,.-. r.. .-•-
H
>,
£ £ S +» B ^
B 0 J5 C 0
g g-M 0 0 0« 13
60 -HO fcfc 0
*» O «O U a LI S
nJS43 Sft So t
a«j rg> -* |
S «H tJ -H-H OX >4
*-0«H V44*4i£
•H > 090 n
*•*> O >*JX 0-0 0
ecu -H ov-S o w
0 0 a 4* 0 Ob TJ
SS M o«Ma«^ »
Si5 015II1 S
18 2 IS«S 1
H rt h 0 0 0 tt «
m< 0 cr»x 0-H 0 0 JJ ~4
> 4J H 0 .
H . B 0 00 J3 4J «M
0 4J 00 C %~
OO 0-O0TJ TJ
H^ 0 o a 3 STJ
f*l S3I1I is
0 0 M-PTJIO -»
^s* ttrslZ as
g If S«§at! •.
•PB^, >OO09 M^.
^21 i6CX 0*>
[P h 00o£ 3 eo
Hq?0 -^JSC-H ^J5
I '
i ,!
g
J »•
s 1
j «
Q£,T>S4J 0 0*
C009 4^M O ^4|x
DO *HOO>04J JJ «9
'JTJ*-' *J C«W C 0H
J 0 C 0*H«M 0 • fi .
i^5>, ^3)i«^§ is
^is -^cjs-si £J3
<4t^M0 0 iH C 3 C CO 0(^
:90tn £0^00" f£
H(W«W< ^, »^^» OH £5
0 J
* • M (M
_ *^l
4 JL '
: " H
> to (o
-------
IH
O
t
•
1 !
I i ^
S 0 ?
is !
^ M
0) 3
1 S
4J ?
O o B*
?j NO S
O o S
* *! s
*"' o S
S » fi
§| *
"> .5 |5
C £ *C
M *?? ^^
•*• 10 '^
o * a
** 8
to S
•g Z
s i
I 1
»
i
s
•s
V
1
s
•^
1
i
1
1
if
5
H
1
s
|
3
1
•
V
S
:
1 1
^
K
s'5
*• •
il
ii
ii
0
lo
~Z w
|o
*
w
r
M
ton
0o
Q NO
« in
.or*
o
*3
H •
^ S * 4i
1 ac ^ ^
i- 5*
% in 5 |
VB "5 ™
jsll
*
N
M
0
o
o
oo
o
CO
. .8$
Suaas
,HQM
|§H<
[•«*
*
4*
• 41
!!
§
•Ilk
-8
si
^•1
,
s *
2
«UCXJ
w
t-
^
*
"*
II
ii
1li
• 6 9
f '
^
<> <>
vr>
> V
^
a ui a
iii
« W N
Hf-HH
i/
p^
V
a||
4
-
*
rH »-» H
"•aS"
H f» CJ
111
H H H
to v NO
^
I
^
* i
l"
H
^:-
.2
»•*-
** «*-
i£
S—
ll
** c
•i
F
^i
•S" $
-5 1
^ • 2
;? i
ET! S
il 1
i" !
I- *
|t \
Ii ?
ifil
fl« i
Ir| •
V +>— —
Sf « Q. w
*
-------
10 •
«iO C J3
o
•H O
*»
C ffl-rt «W
« >«O BJ4J O
•O-H 3 ffl vo
«•-< C 3 ceo
o oirt
""-» U H
-------
O
H
g
&
Sn
| j
ill
Is-
* S i
!i 1
o S
§ o
0> A
< n
§ S
. _i «&
unental Protectj
n, D.C. 20460
ND REGISTRANT'S
S o m
8 ** a
"£ c g
C jj *C
W (5 Sj
(0 ^*
QJ ^ 0£
ii M
5 §
ca 5
% >
S 8
S
1^
i
5
•8
1
S
w
1
i
X
ft
§•
9
I
1
|
*•
£
|
s
2
I
.
\c,
' ,
V
•• \
4
»''•«•
ma a
,*
«>*«
H *4 «-l
'-*
-
*
333
-
^
H iHH
HHH
(0 TO w
'
*
-
-
.
f j
' if
^
ts
**
* 4V
S*^
:i|
III
* * *
-
...^
* > i
d0^0 ^O
s
a
* r
.«
* i
* i
II
s are true, accurate, and
be punishable by fine, 1
i!
ii
5 j $
« —
^M ^ V
— « *
;? i
• *B S
el r
e^i «
5! 1
jl!
1^ ?
«£ « u
S|1 t
• So
«*-- -
1 iji !
U *W Jat O 9
4(
-------
I
"O
90$
(D O
-H-H
h
n
H
J3 O C+> 0
-PUG ja
0 O C
013 « «O
O ffl 3
3 0 C4J 3
•OX O O O
0+J-H 3J-
h *>TJ U
a —H o
VO h<^
o 0 c a-p
4JTJ 0 0
•O O 0 3
•q a fo
0 04J O
CO 0£ t4
3 n*i »o GJC
00 Q4*
•H J3 C-H
Vi+J OJJ«H
0 -H-H O
4t-JS4i 10
o ao c
10 O-H
c 0 a
•HIJ 0 o
JS Q,
i
s
01
0 •
•H —»
*J TJ BJ+J O
•0-H 3 Q «O
o in
* OH CO •
0H c 3 Ceo
0 «H o o in
h^» OH
I
H
to
I
H
VO
-------
Is
>,
u
c
I
o
•H
Is
n
S -
1 g
!>••-( •*
5!s
«s*
HD
J X
AQ3
«mu
X
llV'A
OT6
39Y
1!
Guideline
ulremnt
ber
Q) (0 O
CN f» CM
333
•H r-T-H
*,« *
H W
^i
s?
li
*6 ^
f O *^
«>.s «.
M c • o
"«« .
ii ** ^ •«
Sf. i CL •*
*
-------
:
O
••J
1^
or
&
r-
O
D»
* 9
£ I
o
•H
•P i
SJ 0 a
o us £
• _» ^" ^
Ml
M O H
l«
i - i
§ i i
If 1
> 5 «
«•§ I
"I «
* I
2 §
to 5
•o §
01 w
3 *
e
9
I
1
1
d»
2 «
.P TJ
10 ,
5 *
- §
0 «-H
.8 IS
II?"
*as *
1 * «•» ,
* -=o !
* « g w :
«« -sin <
•> o 8 t*. i
5-*fio t
1
.
** JQ o
jgo S 5
** »» >.
*> c o *» a 21
a «« co
g i*1 « o ogJ -d
SO ^p hG o
1 4J O 'dh 9O' Li
U04J pa iw 4J
|H -P it DO 9
gw^ g,g, 85 §.
S-H-O -H-H 0 >• £
P* * Tj Jj 4* 4* ^
1 -H > O 3 0 n
U> 4J 0 > *i S 0 -0 0
le c h ^ oS-d o
looa *> 0 ou sgoBp-H
Oi O 0 «d S 14 4J
cua 0 AC c
Hi-J MOUOB 0
_ < 0 o»x 0 -H 0 «d
9 . 4> V4J 4J H 0 •
H . B 0 IH C U -«-H 4J ao o
Sg5 oUi^18 S .
*es sse4'^ ^^
0 4* 0 U C 45C-
oo o« (0 ^.
EH O lj Qi —H O iH TJ
•P "d -d TJ S -* H 2.
Iff Sll&« «.
*) B *dUO3 «H »->
««2§ 'g'a.il'o' °S
O-H-H B ffl J3 Lt C
s-d stjS^a om
C O1 0 0O -H in
o o a a «w o +>H
t n . H >,o c5 0 .
PL| 1C Q) O*3 O CO
•H o o . -HJ: C-H ^ 5
n J= £ 4J (0 x> ft
8'5J8 §^^a§ §&
O 0 JO Li S «H «H •- •
d>^H 0 » U 04J -HO
V B J3 O O-H 5
5?^ ^^«08 ?^
g§* ,-§54J 8 § -
c0to i7So -SrT
DO -H O O»0>4J 4J VO
H«d^ 4J C-H«W 0 • I .
JS3& fS*"** ss
^*i 1 2 •*H4Jt-l'd^H «> s
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in
Item 3. This number must be used in the transmittal document for any
data submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required
studies. Note that series 61 and 62 in product chemistry are now listed under
40 CFR 158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattera(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements,
all use patterns are covered by the data requirements. In the case of efficacy
data, the required studies only pertain to products which have the use sites
and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in
rare cases.
Item 8. The due date for submission of each study is identified. It is normally based
on 8 months after issuance of the Reregistration Eligibility Document
unless EPA determines that a longer time period is necessary.
Item 9. Enter onlv one of the following response codes for each data requirement
to show how you intend to comply with the data requirements listed in this
table. Fuller descriptions of each option are contained in the Data Call-In
Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to the conditions for submittai of this study as
outlined in the Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharinf). I am submitting a copy of this agreement. I
understand that this option is available only for acute toxicity or certain
efficacy data and only if EPA indicates in an attachment to this Notice that my
product is similar enough to another product to qualify for this option. I
certify that another party in the agreement is committing to submit or provide
the required data; if the required study is not submitted on tune, my product
may be subject to suspension.
-------
3. I have made offers to share in the cost to develop data (Offers to Cost
Share). I understand that this option is available only for acute toxicity or
certain efficacy data and only if EPA indicates in an attachment to this Data
Call-In Notice that my product is similar enough to another product to qualify
for this option. I am submitting evidence that I have made an offer to
another registrant (who has an obligation to submit data) to share in the cost of
that data. I am also submitting a completed "Certification of Offer to Cost
Share in the Development Data" form. I am including a copy of my offer
and proof of the other registrant's receipt of that offer. I am identifying the
party which is committing to submit or provide the required data; if the
required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-In
Notice (Section m-C.l.) apply as well.
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing
Study). I certify that this study will meet all the requirements for submittal of
existing data outlined in Option 4 in the Data Call-in Notice (Section FH-C. 1.)
and will meet the attached acceptance criteria (for acute toxicity and product
chemistry data). I will attach the needed supporting information along with
this response. I also certify that I have determined that this study will fill the
data requirement for which I have indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgradable (Upgrading a
Study). I will submit evidence of the Agency's review indicating that the
study may be upgraded and what information is required to do so. I will
provide the MWD or Accession number of the study at the due date. I
understand that the conditions for this option outlined Option 5 in the Data
Call-In Notice (Section m-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute
toxicity or certain efficacy data and only if the cited study was conducted on
my product, an identical product or a product which EPA has "grouped" with
one or more other products for purposes of depending on the same data. I
may also choose this option if I am citing my own data. In either case, I will
provide the MHO) or Accession numbers) for the cited data on a "Product
Specific Data Report* form or in a similar format. If I cite another
registrant's data, I will submit a completed "Certification With Respect To
Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am Attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my
-------
request. If the Agency approves my waiver request, I will not be required to
supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies
my waiver request, I must choose a method of meeting the data requirements
of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a
revised "Requirements Status and Registrant's Response" Form indicating the
option chosen. I also understand that the deadline for submission of data as
specified by the original data call-in notice will not change.
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to
report that your product has already been transferred to another company or
that you have already voluntarily canceled this product. For these cases,
please supply all relevant details so that EPA can ensure that its records are
correct.
-------
Attachment D
List of all Registrants) sent this DCI
-------
§
•H
O
e
H
a
a
a
o
M
o>
to
to
jj
c
a
I*
4J
u
•H
O
(0
o
1-1
fli *rt
g fi
. §
a ..-H
h I'D
a) 5 o
i c « w
1-1
in S *
«o i in
o c t-
"'S
*"* S 8
2 jf 8 «(D
^^^0
3P 1* 3F «
i i 1 i i
li
SS 5
» 2 * S 5
» I s s i
>
5 ^
g
~ S 5 11 3
§§8000
-------
Attachment E
Cost Share/Data Compensation Forms
-------
APPENDIX G
Product Specific Data Call-In
-------
Attachment A
Chemical Status Sheet
-------
SODIUM HYDROXIDE: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION '•
You have been sent this Data Call-In Notice because you have
products containing sodium hydroxide.
This attachment, the Data Call-in Chemical Status Sheet, contains
a point of contact for inquiries. This attachment is to be used in
conjunction with (1) the Data Call-in Notice. (2) Attachment B, the
Data Call-In ResponseForm. (3) Attachment C, the Requirement
Status and Registrant's Response Formfor product specific data,
(4) Attachment D, EPA Grouping of End-Use Products for Meeting
Acute Toxicology Data Requirements for Reregist ration, (5)
Attachment E, EPA Acceptance Criteria. (6) Attachment F, List of
All Registrant (B) sent this Data Call-In Notice, and (7) Attachment
G, the Cost Share and Data Compensation Forms for product specific
data, and Product Specific Data Report Form for use in replying to
this sodium hydroxide Data Call-In. Instructions and guidance
accompany each form.
•
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the
database for sodium hydroxide are listed in the Requirements Status
and Registrant's Response Formf Attachment C.
The Agency has concluded that product specific data are needed for
sodium hydroxide. 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 the Registration Division Product Manager 23 (PM 23) who is
assigned to the product, Joanne Miller at (703) 305-7830. All
responses to this Notice should be submitted to:
Document Processing Desk (RED/RD/PM-32)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: Sodium Hydroxide
-------
If you have any questions regarding the generic data
requirements and procedures established by this Notice, please
contact Richard J. Gebken at (703) 308-8591. All responses to this
Notice should be submitted to:
Chemical Review Manager Richard J. Gebken
Accelerated Reregistration Branch (H7508W)
Special Review and Reregistration Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: Sodium Hydroxide
-------
Attachment B
Product Specific DCI Response Forms
(Form A) plus Instructions
-------
«M
0
s
8g «
*$ S
o o
£ss
30 g
*°a
10
to
•3
O
4*
i
!
I
i
II
il
«^
i
ii
in
i 8
0*
w
g
o
sg*
1
a
o
a
to n
A o .
•H in
id r*
tj ^3
^I
a!i
s s
and Haw
l f
Ca
45
lca
ua
se
06
Chml
Sodlu
o
o
O
0
in
o
H
w w
!O S
o 2
*8Hi
IX X
a am 3
^
1
iiW
«*
• • •
in u &*>*<
.
1
O
o
in
1
j
6-
s'l
I*
X —
fl
fe
il
^i
« 8
•|
ll I
I!
I!
iHl
Iri*
8. Cert if (cat 1
i certify that
I acknowledge
or both under
Signature and
I
1
-------
0
0
070-0107
expires 12-
-
1 1
0
*
O
•H
Prote
2046
0
E
(0
,C.
RES
If
^^ UQ -^*
m S 3
0
CO
•o
0
e
p
i
!
i
•^
i
i
i
ii
il
ii
ii
u
H
fe
_ H
:«
^. w
I
•I
*«
2
w
0
B
fl n
£ o
SO
iH in
££
ci
•H 5 J(
S!I
«« 8 8
«O -s .?
Nas»
r-l
O!
of
as »
sij
tiSJi
Jtf?I
|i!il
!Sir*'
-I*
Ii
!!1!
s
"SgSg
!|M
:!!|:
3-f B C
_?•!!
.ffli
-- l,i
•§
»*!
£S
a
CO
N
t
i
!| |
i
e
S-
I
Iri
gm!
6 *• • •-
7 S.i. «
5*f| *
--i5 2
r^ls I
-------
1
s
0 M
_2 w
H
I
IU
»g a
e •*
*>
§
I
I
u
M
U.
- M
a o
5 w
o A
«W
i
2g
a
I"
10
o
U)
in
Case § and New
4065 M
Chealcal * and
Sodlus hydroxide
i
$
' f
e> e'-
£li?i
fill
£ m C
•
4! l.s
"a e v w t>
•-«gi
•t«il
IU C V O
"alls
SSiit
.ii
n
M
n
«*<*>
i*
v *
4
• H.
i^ 1
!
-------
-------
i;
a "B.
o
0 M
*£ so
1-7
Hi
fc » S?
m * Q
v9 *^C ^^
4J
5
CO
•§
§
!
I
I
I
*rf
V **
II
il
ii
ii
U
« o
a
a
o
a
0 CO
Ja o
\o
•H «
ia r*
l*«
|"ij
? :i
*« S i
Jill
o
o>
0k
o
o
3
to
g
oz
u
[OH I
h« ID
H i-l I
5
2
§
^ficf
2 '^ "
'
^ l.i
o
O)
t
«*<•-
!}
if
. i
fl
il $
em and a
•leading
1
!*
n *
— *
» I
••* H JC
4* E *•
«*
-------
S
S
*
i
Q>
o
|S8
2s I
£" S
a
C
.!
-< go
sis
M | S
W
I
§
|
I
1
is
* «•
||
Ii
ii
ii
«o
$9
4)
n
£ O
vc
H IA
25
8 I
5l|«
S 8
I
,« 8 •
g -1
££
M
i,
!MI
|S55*
s sir's-.
s-.ls *g
^ll!
ft-.
O
O
n
1
!l I
:^ i
IS £
M
IH!
11» i
i i
L. M ! E ^ **
• H; i
e — — 5 «
!
1
-------
2
070-0107
Expires
n
?
t!0
S8
1°?
§
I
*
i
s
1
I
1
i
*
si
I!
!!
•• •
«• Z
i!
i!
u
M
EM
„. H
S U
0 w
*&
!
n
o
0)
n
n o
A O
Ift
iai«
i ;!
:s|i
i^ii
1
-rt
WSB
«
s
li
a
m
V*
.-!
e true,
punisha
11
M
!i:
it i
8. Certified
1 certify tha
1 aM»KflOlllOO9ft
or both under
Signat
-------
INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose
this option, you will not have to provide the data required by the Data Call-In
Notice and you will not have to complete any other forms. Further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provision of the Data Call-In Notice
(Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data
exemption, you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on
this form, provide the EPA registration numbers of your sources); 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 (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding
"yes,"
Item 7b. For each end use product (EUP) for which you wish to maintain registration,
you must agree to satisfy the data requirements by responding "yes." If you
are requesting a data waiver, answer "yes" here; in addition, on the
"Requirements Status and Registrant's Response" form under Item 9, you must
respond with Option 7 (Waiver Request) for each study for which you are
requesting a waiver. See Item 6 with regard to identical products and data
exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to
report that your product has already been transferred to another company or
mat you have already voluntarily canceled this product. For these cases,
please supply all relevant details so that EPA can ensure that its records are
correct.
-------
Attachment C
Requirements Status and Registrants* Response Forms
(Form B) plus Instructions
-------
if'
'-* •*
N
IM
O
f
IJ
i *
i *
i 1
e I
w
S
§
•H
4*0
O <0
«*•
4*0
8"
£
3?
Hm frc
»| W
« g
to
g
?!
w
1^1
o
H OV
fr.0
« M n
SO (M
M I
4>
IN
n
o>
n i
2 S
in
in
in
§
H
IS u
?p p
s
*•
i£
5 »•
|K^ : • :^:« ' • :^>« -• • ^'i^' •
ilQ' OH :iW OJ TO" GO -tO (0
& • :**>.. SlK'S • SSS
•:•: uk -;ij«-- :•••••:•- ; .A .,-:•:-:•
s 10 slu ;-*jSJ Q •&;?
S* O iO • H|5S O j^is
|co Hi Illeo lilco Hfeo |o a p.:; > „
fti ~ fti Ai CU & 04 (It .. 0«
W WWWttWWMHW
OO
:;::^ |^j
ii ^D "^3 '•
>> ^j "LJ •
Is a:
"O O
fc CM
61 £}
|Q&
;C3 03
O OOOOOOOOO
ig;
:5W:
! &£ M K 'S^ :K -M w &M
i *P3' ^3 -"O ^5 ^5 ^3 -^3 ^3
I H H 1-1 M :H H H H
a a- a a as s a ac
o u o o o o o o
. j fo b frrfr* fa tn fci Ui
:;M M M &] u ja U U U
SQQQQQQQD
oo
OQ flQ
oyo
03 CQ £0
ll|;^ m \
iti !^*
ltl«:^g:
I84i--^i?
itasiB&Aii
li^^^iii^i
; t&
c
*
* I ;:l
^HH'
SWAO
fH1
sivo:
«j- tn « r«
i 1 t l 1 1 1 I
P
* *
il
+* w
'* i
*! 1
sl i
Mde
ly f
o
I
o ~ k JT
«- —— 5 «>
-------
Ci
.o
CM
*
IM
I !
S
H
| £
I n
" o
v>
CM
£
•—i
3d
§ .
II
ex <.
BJ
"^ g
10
41
CO
1
4*
•H
II
H
ii
U
W O\
~ H r»
1^8
I
a
a
g
9 ffl U £t3 U jU
O CQ £0 CO CQCQflQCOCQfQCQCQCQlO
v
»
I!
0
-------
!
£
» a»
i i
ii
i
«
o> w
W
•s
i
i
ii
D.
>. •
ii
ii
ii
OH
H H
b n
to-05
W I
1
CO
§
in
i
ni
o
as
H
g^
RO
SO
o
in
a; o M
W VO J
« CMfc
1
85
ii
deline
4. Gu
Requl
Nurtw
:J
• « • »
CO CO
CO COCOOCOGOCOCOCOCO
M H
I
A
H
SS S
UU MHUUHMU
------ 1<-
oo
gg
gg
^
o oooooooo
HUMHMMMH
' sea: as aeac
otso
fib fiu fib
o o o o o
FBJ ^^ ^^ C^ &^
MHHtdCdHUUU
O QQ QOQQQQQ
o ooooooooy
Bl D3 OQ DQ flQ 03 03 OQ
CQ
I w
8 i I - ^
I s« g * , . ,
• *
i=. -- . *
1*1 .* -
* S ft '•• ** «* *<
•I':-** 5 6^^-^- 5>~||
1 - • « ££238-.,**
-«
4^
H w
Ii
I
t-t
VO
H w n
l i i
,
« n ^ in to r»
i i i t i l
n n «n n r> r>
I
** S
if i
il f
Is I
F!
I*J5 S
2fH
j«ni
** *«
nil i
uf §
.Hi!
1
-------
(N
O
r*
O
Ck
o •
5 |
i t
4> O
O V)
•PO
0«
£ *
o
, 4
|0
0 -
u a H
« to
ft)
*>
a
•P
1
S
1
I
i
II
II
ii
Ii
OH
EH
f>
, H C4
!
tt CO
a n
0 *•
A r*
2
D>
S
tO
O
* > H
!Sgs
N»N
&M «) »J
tac
• *
•* «
10 10 .10 0) 85 IS >tt
£0 00 tD CO COXOCOAOCOCOCDOCO tEO
tO 10 .IB tO •.-....-. t) .10
iiii
HWHWH1-IHW
x xaca x ts atcsa
U« UM HliI
a a
S cES
g
o
«a O«H
i i i
tO C"0 TO '
H«HH«-IH«-IHHraO9
I I I 1 I t I J I J
on on th
inf
one)
si
Is
Ig
ts
il
4* **
»s
-------
-
I!
cr <
H to H
(0 U
O 3:
Q) SO
<0
U
1
I
IZ
-I
51
ii
UM
„ H «
. W I
I
to
*
to
0)
to
2
§
1
i
fM
in
? S
• ft
n
I
n
CO
s
o>
S
5
1
|«
*H
BID , Q CQtflfflOJWtilMOffl
OO O O O O O O O O
E B , H B B E B B fi E
,' » ' ^ *
COW J CO , CO GO CO CO CO CO CO :CO CO
H H H M M W M
K :^ H H ,-^ IScpi- c
I'" H ;?'lW W W W W « H H W
po
gg
u u
QQ
^^
«
o ooooooooo
j
H-H-HtH-H
acjcastcsExacx
M MMM&1[ilft3:|a&3Cl3
S SSSSSSoSS
O " t) O O O U -U ;O -O O
it! '*
(L S « c *>
11 i 5 v
-------
CM
O
CM
UCM
H H
fa f)
H
IB"
Ǥo
tt m
fl> I
(0 CM
id
A
H
GO
•
m tn
i!
CO
O
*ft °
J!l!
tn
o
in
-i
si
"
» CO
ii§
eo««weowco»cp«o
fit Oi Ai CU (W 0< A* Ai .P<
£.S£E»SSSS
0 00 OOOOOOOOOO
O O O O OOOOOV5
^b Eb Eb L^rf < Eb ^b L^ fb C*W Cb
HUH 64
OQQ
' O O O
WWWWWWWWWW
QQQODOQOQO
O O U O O O U O
.11
fill
1*1
-
•
W
«
*
TT
VO «
ll
HrHH«>iHi^H<-IOt
-------
i
£
§
•H
+J O
o to
•P O
?*"
*«5
iH
IB •
go
0) »
i§
Cfi
W M
as
5
to
U n
I
CM
s
1
1
IL
!!J
m to
1*1
t«M.
Sss KC% '--s-t.. ^ • -*<•- S^-4
i":-:-:-: ;-..-.-.* :-:-.-. -->-.:. •••-..-••. >.,:••:>
^;.5 • '-:ys «>.'.»' ••-*« »;:---»; «y« •
$&»•?
': O O O O
||i;,g;e|i;i£ ^
|i|«o || |«p g-eo p'-co |cr«o ii^eo
I» -H H H
I :••,•:-:•:• '£••• '^** ' _tf
i1&8; i~«. «• .*»'
:gg.: m
m&m S*;HP.: i?r
li-dll'dll if'-eii
s«O ?wa •
leaei
:->-.;. :-**',-
:>::: ATifc
jfljiirtii pji§i
i S-S:iiS ja^i ;«.:-. *:«
;,::;,,;o, sin, ft, o, arc. w
W W W W W W H H W
000000000
^:^*^r_ ________
i»si:H ;,-.:XH H ,H H H H H iH ;H
:"*;O :i;i9 O O O O X5 O O O
[L| :.:.:;:i:(L| (L| (L| fe [L| (L| .(bt fa (L|
i :•:. -:••
W:--'';''::M *VI M
.-:-::::':'• *2? '^^ *^r
.tO '•',-f.tO (Q 0 CQ 00 CQ CQ CQ CQ
•;<:-:-< «" " "
-r^fc -','':;l, *% ';' : *"»-'*^ V
i*y -;•:-:,.: K» ^^ •• •«« 1. . .
«; - - :::::.;p. •;>•;:;••:;• «. • *• •
£ .'i^1 •:#;- :?'V. :;''?' ''' '•
W
!
J
• ^ X'
Ji
*< «
11
;--f?
'***<£•
gst-v r^-
iaigi *s
;236'
'*• -^Ct
1 ;•«. i .-•
Illlx:
IallM.lt li liii s
;SH iH
; »0 SO -
' :-.:::>:-'.' ::r-:;:-:-: •
•f!>* «." ,<:.. •: - i
?j«-i:« n « n * in ?
I II i
i f^ r> -f) fi i
il
SxS
211?
— 4)
J*I1!
-------
W
0
CM
I
* i
! s
C» ft
o
Ho ?
^ g
r
u
H
3d
C O <
»4<& W
•H C P
>-H ft
cr S
3
W
•O
8
•H
e
•K
£
I
fe
rs
!l
H
ii
U n
M H
fan
- H CM
«So
* ft* 05
!
^
7
o>
18
*J O
V 2
t
in
w
•
H
9404
* 5
w 01 S
EH P>CQ
I
fi
•
•8
I1
'»•
tt tO 10 ID U fO 10 10 ID fO 10 W iO
CPCO«CO, COW «« «» »«> 80 W
1-4 H
^CU £M CM Iki Ot lk« CM HU 0< CU
W WWWWttWWWW
O O O
Q QOO.P
&K&K
S H *3 H
Q QQQ
S<<2 S<
O O
b *o b *a>a *?^ *a
M M H « H iH H *4 W M
aasaa waasa a
U -p p :p.;O O O O P -O-
^b ^^b''' B^^ "^h ' Gb *fib bi -^b ^b ^b''
§§§§S§§§§^
i u O O UiO
5 5 S 512
144; 4 «•«; <;
jl
ii
g
«->
X
"
i!
t
OH
1111
<^ f)
to u> n> to ;
Nft •»«> »Ot* <0<
«Ht-IH-H«HiHrH«
I t I I I I I 1 I I
K
gg
ii
n
e *•
-g
L
-------
M
1 !
1
* i
! i
f
v
i
10 •
r.
f!
•H R
>*H
£<§
10
4*
RJ
(0
0
B
i^
ii
«. H N
4t
O
D
n
2
S
in
o
CM
O
£
I
H
CO
O
co
a«
~ OKI
§ OO*
fc-Z in t->
«S
H H
o
fw
n o
~J
co
nnniAiocOBiton
o o o o o o o
CO fO CO 40 CO CO CO CO CO
; « :;.g /g;' I
f: 1 :Si'I:- is*.
;/ CM CM ' Pi CM £M CM CM CM £M "pi
W W W WW6JWWWHHW
* "g
oo
H
t > ,i i
H «-« '• 'r-i sen
1 1 l t 1
n n r>
P
U
if
$
i
i!
i^Ili
*
«rf g **
Js •• •- O
-------
&
ii
ii
ii
0 H
Q) I
ID O
BJ O
A o\
«
h O
0) Z
a m
£
in to to . to 'to to to to to IB 10 to ..to
; Q Q O • O 0 O O O O :;O
EEEEEEE6EE
.GO Ct>:CO COtDGOCOCOflDCO£OCOtD
U fid 'U JU U W W W W :M'
< g< £j g« g« gj pj g« £< Oj gi
cu as g ac a as as aa a as
oooo oooooooppo
JH H W H
HMMM
KtCX
M
O Q O O
. Jf =.''. j^ ,.fiA O >• PJ «;-.;: »O 5^ ktlV
i • ""A' » V.-S »• :»• ^ IJ-S.::.: ^ sw« ;••-
• +* ...:.-.; ; W -•-:•,-::-: *^ .-^ ^ ••;•.::-•'.:: \* .** '•?**•
-•-.•:•- .-.-. • •:,•. .- •-•••.••-,- •:-_ ,.-. .• •_>..
i i:
S<-:- _ yf.
?%{ c:
;.i
12
';J»».: O
siisi W
m t
C>.£
t^^si
*«
I
•
5
S
g
s
ss
u
II U
II
ll
8I
-------
•4
o
1
i I
! *
1 I
I? a
i I
II
f4 C
w
United
£
S
7
I
X
!
II
ii
ii
in
UH
2n
CM
H 1
O
tt
10 I
0) O
to o
10 f»
A O
10 •
M O
ID
H
t
CO
S
6
•JH
< to
20
< - CO COCOCOCOCOCOCOCOCO
2
t-l MHM
oo
oooooooo
t-> 1%^ >s n »D rj fj >3 "»a ;^>
; H ,vSH H H H H H H W H
ri
O 'O.O
'ft^ :ftL -fc.
, w iiiiuUHwwwwwtdww
^v.;:O .O :%Q :'-:^O O O O Q O Q Q Q
Bl=l'
.-
fe 1
•
£•.;:*« ?..;.,. K4' W'K- m:
•~':'** ^x' «'• ^- ^v
«s :> «-t n r» w m «» in »0 r>
I ; I I I.I II I :l I
tH' .;:"N N N f> t*l ft f> f% M
l«
Si
If
1-
**
II
I
on thi
lM or
iz
Ii!
Ill f
-• *
Itll
*• *• 9
fc z
U i-
o —_ ^ —
-------
tl
- *>
ii
ii
in
OH
fc CM
H I
O O
o
o
ra
S
i
o
o
B
,
1-H
in
H
!
<« 0.
itO«-OtJO.
•'>:•• » ;:';':*'" * :
0) 10 ID ;
I ?tfl O Slfl tfl .^fiQ tO : w CQ *t0
I *O O --O - O ':O' O ' O O ^-O
: eo W;00 iffCO W CO 90,CO wjO ijBO:co i6:
.•Oil
:g»i*
CO •:•'"'•>:"•:
oiifo*
*ffis?^"
g«>«>
o o p o
o.o op p p p
.OOOO -:' •'• • O O O O O O O O O O
(D (i< h h ^}ls< fLibftibkbblMbifa
« H«H :::::U WUWWWWWtaW
:* Q Q Q O Q Q O Q Q O
OOOUUO
60 "CQ CQ -fit)' CQ £&
-:•: -•;•:• _ ».-: .- ._ • -:•:•;-,-. ^ :T_^.
i?£R£l;c£:|
«6"Ot « H
I I I I i
it ft fi n ;
10 VO U> VO r
I I*
I I i-1, I
r> c*> ci c*>
ii
I
6
S
s
i§
I*
eg
t«
82
|1
Is
It
e *•
:i
ll
-------
II
!i
&
I
H
§ ^
•H CO
4J O »
OVO "
0) •«•
•P O
O C4
fl •
^O
0)
Se
I
Sf
S*
4J
flj
4J
CO
! 1
§
5
S
I
I
I
!
1
*>
Ii
ii
UH
H n
ws
63
Sx~
° o« H
£
S
» in
to t
0) <•
10 40
to n
2 o
l| ^
•B §^
in
w
i
KD
O)
C «_i Crf fwi
Ot
£«.
•**• C
41
HI
• 4
m to
CO CO
CO {fl (0 *iO CO ^Ifl 69 (Q CO
iiiiiiii0
w'y-.1-
K:
8>&
Its ;N:
'"lifctt;
H H -H H H H
• iiS: £*£ Mil *".> !•;••*'. >£$
iiifi ili*«B «•; SB ' tJ 13' %&*o
;g;:C; illlB
••«»•: ^«
•: -:S:S;S «:.::;S
afucud, o-
WW MM W
v:::::-:':- ^ :-.-y-.:x i
gffigi E ii:.:-;;: I
ii?l ijs&s SSi?
«*S«. ji:::»:«. St^/
o o
^«S.
•*!•.*} t-t
:.v:.»H H
^88 «-
::yP P..
x:V'-b &E4
::^V;:H H
"S-Q Q
::MU O
siteo ffl
^;.ii<<<-
©00000
:::':?'i:'D
ss;iC):
:•.-.-:'•:: ?J1 •,
•rv" '•!.- BQ
UUUUUUblU
QoSSSSSS
00 ;•;;; c ";«.i :#.^ :-».. ^'i-
git's If WiS-llii:
^lll^ri'sll"!!^
«• ¥' s -S. -5:5 • ^::;:^ 5 ^' ^-:^ ^
*-''
I : 1
I-C rt
-s
1
-------
o
rt
I
O H
ST;iw »& ;*i;
:---;-;:- - -;-:•:-:•:-; I'A-':-:- •:-' >:-'•' :•:-:•--:•:•
;?S*: ssa sss; s-;»: ss-s
S 111 li Ul:.: 1§
tfi'"' f\ -ft""'-' /
|jq m |£|:gCJ U U |L| U :
tlllll
p po moo o oo o o oo p
w u .
£) O> Q'Q :;vi-::i-
W W W W W W W W:WW
;•!'•
&
X. ^
*« '!K::
8.1!
^: fc iii-
f;S5i:
*_
••* £ :;«: :?B
IS *$£»!»
:>. K ::^-: • -—
••P- B .:-*«-- 5 o
••f £ :-'-•: %. :-«^
*~ * ^ :'TT >. *± i"^*"
g
ii
mt
II
: >>:--r
. :^K ff sS' ¥;S:;: 5 tg
j ??; ? ;;^?; >• j^i g IT
j»'' i^ :^X~': «^ :>*#
6 8 i£ 8 -:-%
0;i£ ^::S 5:X U S
$?* iS:« P'ieo iii-o W.
H MiH irl H ¥4.i-l tH H
-------
INSTRUCTIONS FOR COMPLETING THE 'REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in
Item 3. This number must be used in the transmittal document for any
data submissions in response to this Data Call-In Notice. '
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern Use conduct of the required
studies. Note that series 61 and 62 in product chemistry are now listed under
40 CFR 158.155 through 158.180, Subpart C.
Item 5: The study tide associated with the guideline reference number is identified.
Item 6. The use pattera(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements,
all use patterns are covered by the data requirements. In the case of efficacy
data, the required studies only pertain to products which have the use sites
and/or pests indicated
Item?. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in
rare cases.
Item 8. The due date for submission of each study is identified. It is normally based
on 8 months after issuance of the Rengistration Eligibility Document
unless EPA determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement
to show how you intend to comply with the data requirements listed in this
table. Fuller descriptions of each option are contained in the Data Call-In
Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to the ffffpditiony for submittal of **»<« study as
outlined in the Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I
understand that this option is available only for acute toxicity or certain
efficacy 4N.f* and on|y if EPA indicitff in an attachment to ***** Notice ***** my
product is similar enough to another product to qualify lor mis option. I
certify that another party in the agreement is committing to sutroH or provide
the required data; if me required study is not submitted on time, my product
may be subject to suspmikm
-------
I have made offers to share in the cost to develop data (Offers to Cost
Share). I understand that this option is available only for acute toxicity or
certain efficacy data and only If EPA indicates in an attachment to this Data
Call-In Notice that my product is similar enough to another product to qualify
for this option. I am submitting evidence that I have made an offer to
another registrant (who has an obligation to submit data) to share in the cost of
that data. 1 am also submitting a completed "Certification of Offer to Cost
Share in the Development Data* form. I am including a copy of my offer
and proof of the other registrant's receipt of that offer. I am identifying the
party which is committing to submit or provide the required data; if the
required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-in
Notice (Section m-C.l.) apply as well.
By the specified due date, I will submit an existing study that has not been .
submitted previously to the Agency by anyone (Submitting an Existing
Study). I certify that this study will meet all the requirements for submittal of
existing data outlined in Option 4 in the Data Call-In Notice (Section IH-C. 1.)
and will meet the attached acceptance criteria (for acute toxicity and product
chemistry data). I will attach the needed supporting information along with
this response. I also certify that I have determined that this study will fill the
data requirement for which I have indicated this choice.
By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgradable (Upgrading a
Study). I will submit evidence of the Agency's review indicating that the
study may be upgraded and what information is required to do so. I will
provide the MRTJD or Accession number of the study at the due date. I
understand that the conditions for this option outlined Option 5 in the Data
Call-In Notice (Section m-C. 1.) apply.
By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute
toxicity or certain efficacy *fa*» and only if the cited study was conducted on
my product, an identical product or a product which EPA has "grouped* with
one or more other products for purposes of depending on the same data. I
may also choose this option if I am citing my own data. In either case, I will
provide the MRID or Accession numberis) for the cited data on a "Product
Specific Data Report" form or in a similar format. If I cite another
registrant's data, I will submit a completed "Certification With Respect To
Data
Requirements* form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I IF* ft*«ghfap a complete Justification for thit request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand mat mis is my only
opportunity to state the reasons or provide information in support of my
-------
. request. If the Agency approves my waiver request, I will oat be required to
supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies
my waiver request, I must choose a method of meeting the data requirements
of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a
revised "Requirements Status and Registrant's Response" Form indicating the
option chosen. I also understand that the deadline for submission of data as
specified by the original data call-in notice will not change.
Items 10-13. Self-explanatory.
NOTEt You may provide additional information mat does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to
. report mat your product has already been transferred to another company or'
that you have already voluntarily canceled this product. For these cases,
please supply all relevant details so that EPA can ensure mat its records are
correct.
-------
Attachment D
List of all Registrants) sent this DCI
-------
8
£
H
C
10
to
IS
•*•!
J
Ij fll
•P -O
IQ *^4
, §
a b
o "O
to >•
w
in 5 \o
o O
» vo-g
So J
« u
§<
•
5
Q
«
3!
5 1 -
i§i
S
S
S
5 R > 5 85
S S i 5 8 5
» § 5
*
I
i
i
- •
s s 2 5?
«-• •-* ac *
z in o
g »-• 5 °
nl N
•*•
o <*
S S
f^ tO
-------
EPA'S BATCHING OF SODIUM HYDROXIDE END-USE PRODUCTS FOR
MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
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 sodium hydroxide, 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 may not be considered chemically similar or have identical use patterns.
Batching has been accomplished using the readily available information described above,
and frequently acute toxicity data on individual end-use products has been found to be
incomplete. Notwithstanding the batching process, the Agency reserves the right to require, at
any time, acute toxicity data for an individual end-use product should the need arise.
Registrants of end-use products within a batch may choose to generate cooperatively,
submit or cite a single battery of six acute toxicological studies to represent all the products
within that batch. It is the registrants' option to participate in the process with all other
registrants, only some of the other registrants, or only their products within a batch, or to
generate all the required acute toxicological studies for each of their products. If a registrant
chooses to generate the data for a batch, they 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,
they 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. Regardless of whether new data is generated or existing data is
referenced, registrants must clearly identify the test material by EPA Registration Number.
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
DO 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 they will provide the data or depend on someone else to do so. If a
registrant supplies the data to support a batch of products, they 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, they 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 their studies
and offering to cost share (Option 3) those studies.
Table I. All products containing sodium hydroxide were batched together. It was felt that the
high percentage of sodium hydroxide was the major factor in determining the toxicity and
-------
irritation potential of these products, and all these products would have a comparable toxicity
and irritation profile.
EPA REG. NO.
500-22
7742-8
8132-3
9902-1
9429-2
10700-2
11364-5
% of Sodium Hydroxide & Other Active
Ingredients
98.50% - Sodium Hydroxide
80.00% - Sodium Hydroxide
20.00% - Sodium Chloride
85.69% - Sodium Hydroxide
0.30% - Copper Sulfate
98.00% - Sodium Hydroxide
2.00% - Copper Sulfate
70.00% - Sodium Hydroxide
15.00% - Sodium Metuilicate
85.00% - Sodium Hydroxide
0.30% - Copper Sulfate
56.00% - Sodium Hydroxide
0.50% - Dtchlobeoil
Formulation Type
Granular
Granular
Granular
Granular
Granular
Granular
Granular
-------
Attachment E
EPA Acceptance Criteria
-------
81-3 Acute Inhalation Toxicity in. the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. Statement of the inhalability of test substance
3. The number of animals/sex/dose
4. Duration of inhalation exposure
5. Number of chamber air changes/hour and the percent oxygen
content of chamber air
6. Ranges for chamber air temperature and relative humidity
7. Air flow rate
8. Analytical concentrations of test material in breathing zone
9. Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
11. Individual -observations on day of dosing and for at least 14
days.
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
-------
81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
l. Identify material tested (technical, end-use product, etc)
2. Product is a gas, a solid which may produce a significant
vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter
15 urn or less).
3. At least 5 young adult rats/sex/group
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at
least 19% oxygen content.
6. Chamber temperature, 22° C (±2), relative humidity 40-60%.
7. Monitor rate of air flow
8. Monitor actual concentrations of test material in breathing
zone.
9.- Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category
or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days-
13. Individual body weights.
14. Gross necropsy on all animals.
-------
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. The number of animals/sex/dose
3. Weight range of animals
4. Verification of single, dermal exposure
5. Duration of dermal exposure
6. Statement of vehicle control
7. Doses tested and results
8. Preparation of application site
9. Area of application site (percent body surface)
10. Occlusion of test material on application site
11. Individual observations on day of dosing and for at
least 14 days or until all animals appear normal (whichever is
longer).
.12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
-------
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 animals/sex/group
3.± Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-
450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.*. Vehicle control, only if toxicity of vehicle is unknown.
.7. Doses tested, sufficient to determine a toxicity category
or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours
before dosing
9. Application site at least 10% of body "surface area.
10. Application site covered with a porous nonirritating cover
to retain test material and to prevent ingestion.
11. individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-1 Acute Oral Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g. solid, liquid, percent
AI in technical, end-use product, etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9. Significance of changes from the Acceptance Criteria
-------
81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 young adult rats/sex/group
3. Dosing, single oral may be administered over 24 hrs.
4.*. Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category
or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all
test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit.
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
81-7 Acute Neurotoxicity in the Hen
-------
63 Physical and Chemical Characteristics
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Description of color.
2. Description of physical state.
3. Description of odor.
4. Indication of melting point (in C°).
5. Indication of boiling point (in C°>.
6. Indication of density, bulk density, and specific gravity.
7. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
.11. Indication of PH.
12. Description of stability.
-------
63-8 Solubility
Determined in distilled water and representative polar and
non-polar solvents, including those used in formulations
and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if
sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from
measurements made at higher temperature if pressure too
low to measure at 25° C)
Experimental procedure described
Reported in mm Kg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably
about 20 - 25° C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25" C
Experimentally determined and description of procedure
provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20 - 25° C
Measured following dilution or dispersion in distilled
water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
-------
63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of
Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms
such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms
such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in C"
Any observed decomposition reported
63-6 Boiling Point
Reported in C°
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in
g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk, density of
registered products may be reported in Ibs/ft or
Ibs/gallon.]
-------
62 Analysis and Certification of Product ingredients
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Number of representative samples analyzed for all active
ingredients and all impurities at > 0.1%.
2. Degree of accountability or closure in analyses in item #1.
3. Chemical names of toxic impurities which were analyzed for
levels <0.1%.
4. Brief description(s) of analytical method(s) used to measure
active ingredients and impurities in items #1 and #3.
5. Statement of precision and accuracy of method{s) in item #4.
6. Chemical name and quantities observed (range, mean, standard
deviation) for each ingredient (actives and impurities)
analyzed in item #1.
7. Proposed upper and lower certified limits for each active.
ingredient and intentionally added inert with brief explanation
of how limits were determined.
8. Proposed upper certified limit for each impurity present at.
>=0.1% and certain .toxicologically significant impurities at
<0.1% with brief explanation of how limits were determined.
9. Brief description of analytical method(s) used to verify
certified limits (if same methods as item #4, may reference
latter).
10. Statement of precision and accuracy of method(s) in item #9
(may reference item #5 if applicable).
-------
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
l. Five or more representative samples (batches in case of
batch process) analyzed for each active ingredient and all
impurities present at > 0.1%
2. Degree of accountability or closure .> ca 98%
3. Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
. or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines both fresh and stored
.samples must be analyzed.]
4. Complete and detailed description of each step in analytical
method used to analyze above samples
5. Statement of precision and accuracy of analytical method
used to analyze above samples
6. Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient
7. Upper and lower certified limits proposed for each active
ingredient and intentionally added inert along with
explanation of how the limits were determined
8. Upper certified limit proposed for each impurity present at
> 0.1% and for certain toxicologically significant
impurities at <0.l% along with explanation of how limit
determined
9. Analytical methods to verify certified limits of each
active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally
recognized as safe by FDA) are fully described
10. Analytical methods (as discussed in #9) to verify certified
limits validated as to their precision and accuracy
-------
61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered. Items 1, 2, 3, and 5 can be
satisfied for most registered products by submission of the
Certified Statement of Formula Ingredients Page (EPA Form 8570-4).
Items 7 and 8 can be satisfied for most technical grade active
ingredients (TGAIs) by submission of a flow chart with chemical
equations for each intended chemical reaction. The flow chart
should include complete chemical structures and names for each
reactant and product of all the reactions.
1. Name of technical material (include product name and trade name,
if appropriate).
2. Description of each active and intentionally-added inert
ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert
ingredient.
5. Chemical name and Registry Number for each active and
intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
and any experimental or internal code number for each active
ingredient.
7. Description of each beginning material in the manufacturing
process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
chemical theory.
-------
8. (continued)
9.
Flow chart with chemical equations for each intended
chemical reaction
Duration of each step of process
Description of purification procedures
Description of measures taken to assure quality of final
product
Discussion of formation of impurities based on established
chemical theory addressing (1) each impurity which may be
present at >. 0.1% or was found at .> 0.1% by product analyses
and (2) certain toxicologically significant impurities
(see #3)
-------
61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
l. 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 2. 0.1% by weight and for
certain toxicologically significant impurities (e.g.,
dioxins, nitrosamines) present at <0.1%
4. Purpose of each active ingredient and each intentionally-
added inert
5. Chemical name from Chemical. Abstracts index of Nomenclature
and Chemical Abstracts Service (CAS) Registry Number for each
active ingredient and, if available, for each intentionally-
added inert
6. Molecular, structural, and empirical formulas, molecular
weight or weight range, and any company assigned experimental
or internal code numbers for each active ingredient
7. Description of each beginning material in the manufacturing
process
EPA Registration Number if registered; for other
beginning materials, the following:
Name and address of manufacturer or supplier
Brand name, trade name or commercial designation
Technical specifications or data sheets by which
manufacturer or supplier describes composition,
properties or. toxicity
8. Description of manufacturing process
Statement of whether batch or continuous process
Relative amounts of beginning materials and order in
which they are added
Description of equipment
Description of physical conditions (temperature,
pressure, humidity) controlled in each step and the
parameters that are maintained
Statement of whether process involves intended chemical
reactions
-------
SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
-------
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2.'
3.
5..
6.
7.'
8.'
9.*
Identify material tested (technical, end-use product, etc)
Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <. 2 or > 11.5.
6 adult rabbits
Dosing, instillation into the conjunctival sac of one eye
per animal.
Dose, 0.1 ml if a liquid;.0.1 ml or not more than 100 mg if
a solid, paste or particulate substance.
Solid or granular test material ground to a fine dust.
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 shorter).
individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-4 Primary Eye Irritation in the Rabbit
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, cause severe dermal irritation
or has a pH of <2 or >11.5
3. Number of adult rabbits tested
4. State method of dosing, i.e., instillation into the
conjunctival sac of one eye per animal
5. Dose administered•
6. Note whether solid or granular test material has been ground to
a fine dust
.7. State whether eyes were washed and at what time post
instillation (not less than 24 hours)
8. State whether eyes were examined and graded for irritation
before dosing and at what periods after dosing
9. Individual daily observations afterwards, until eyes are normal
or for 21 days
10. Significance of changes from Acceptance Criteria
-------
81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1,
2.
3.
4,
5,
6.
7.
8.
10.
11. *
Identify material tested (technical, end-use product, etc)
Study not required if material is corrosive or has a
pH of <2 or > 11.5.
6 adult animals.
Dosing, single dermal.
Dosing duration 4 hours.
Application site shaved or clipped at least 24 hours prior
to dosing
Application site approximately 6 cm.
Application site covered with a gauze patch held in place
with nonirritating tape
Material removed, washed with water, without trauma to
application site
Application site examined and graded for irritation at 1,
24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
Individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-5 Primary Dermal Irritation Study
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2, State if material is corrosive, has a pH <2 or >11.5, or has a
dermal LD 50 <200 mg/kg
3. Number of adult animals tested
4. Amount applied
5. Duration of dermal exposure
6. Preparation of application site (shaved or clipped at specified
time before dosing)
7. Area of application site
8. Method for occlusion of application site
9. Note removal of test material and if skin was washed with water
10. State times post application when site was graded for
irritation
11. Individual observations for day of dosing and individual
daily observations thereafter
12. Significance of changes from Acceptance Criteria.
-------
81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3. One of the following methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous .test
' Mauer optimization test
Footpad technique in guinea pig
4. Complete description of test
5.1 ._ Reference for test.
6. Test followed essentially as described in reference
• document.
7. Positive control included {may provide historical data
conducted within the last 6 months)
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-6 Dermal Sensitization in the Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. Complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria
-------
81-7 Acute Neurotoxicity in the Hen
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
3-1.
4._
5,
6.
7.
.8 *
Study performed on an organophosphate cholinesterase
inhibiting compound.
Technical form of the active ingredient tested.
Positive control utilized.
Species utilized, domestic laying hen 8-14 months of age,
Dosing oral by gavage or capsule (dermal or inhalation
may be used).
An acute oral *LD is determined.
Dose tested equal to an acute oral LD or a limit test of
5000 mg/kg.
Dosed animals may be protected with atropine and/or 2-
PAM.
Sufficient test animals so that at least 6 survive.
Negative (vehicle) control group of at least 6 hens
Positive control of at least 4 hens, (if used)
Test dose repeated if no signs of delayed neurotoxicity
observed by 21 days after dosing.
Observation period 21 days after each dose.
Individual daily observations.
Individual body weights.
Individual necropsy not required.
Histopathology performed on all animals. Tissue to be
fixed in sin preferably using whole animal perfusion
techniques. At least three sections of each of the
following tissues:
brain, including medulla oblongata
spinal cord; upper cervical, mid-thoracic and
lumbro-sacral regions
tibial nerve; proximal regions and branches
sciatic nerve
Criteria marked with a * are supplemental and may not be required
for every study.
-------
Attachment F
Cost Share/Data Compensation Forms
------- |