United States Office of Prevention, Pesticides EPA-738-F-92-OG7
Environmental Protection And Toxic Substances August 1992
Agency (H-7508W)
f/EPA R.E.D. FACTS
Zinc Salts
Pesticide ah pesticides sold or used in the United States must be registered by
Reregistration EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be ^registered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Document, or RED. This
feet sheet summarizes the information in the RED for zinc salts.
Use Profile Zinc salts include three pesticide active ingredients: zinc
chloride, zinc oxide, and zinc sulfate monohydrate (or zinc sulfate). Zinc
salts are used as herbicides to control the growth of moss on structures,
walkways, patios and towns in rainy areas, primarily in the Northwestern
U.S. Zinc oxide also is an industrial preservative, incorporated into carpet
fibers to inhibit bacterial and fungal spoilage, and a bacteriostat, applied as
a pressure treatment to preserve cut lumber. Other, more significant, non-
pesticidal uses of zinc salts in the U.S. include use in fertilizers, animal
feed, dry cell batteries, and as galvanizers.
Zinc Is an dement necessary to all forms of life. It is a normal part
of metabolism in all living organisms. Zinc is widely distributed in plants,
animals and soils, and is normally present in food.
Regulatory Pesticide products containing zinc salts were first registered in the
History U.S. in 1973. At present, 10 such products are registered. Nine of these
products contain zinc salts as their only active ingredient; one also contains
another active ingredient.
-------
Human Health Not all the toxicity data usually required for pesticide reregistration
Assessment were necessary to assess the human health risks of the zinc salts because
much of this information was available in scientific literature available to
the general public.
Toxicity
Zinc chloride is corrosive to the eyes and skin. It has been placed in
Toxicity Category I (indicating the highest degree of toxicity) for these
effects. Zinc sulfate also has been placed in Toxicity Category I because it
can cause severe eye irritation. Zinc oxide is of relatively low acute
toxicity.
There was no evidence of toxicity in a subchronic feeding study in
which humans were fed zinc sulfate each day for up to three months.
Regarding effects on metabolism, zinc is an essential element in
human nutrition and is part of the nutrition of all plants and animals. It is
an essential component of several enzymes involved in human metabolism,
and is present in every cell. In laboratory feeding studies, most of the zinc
eaten by test animals was excreted. Ingesting large amounts of zinc salts
does cause changes in metabolism; however, people usually are not
exposed to such large amounts of zinc through the diet.
Concerning chronic toxicity, when laboratory rats and dogs were fed
large doses of zinc sulfate, changes in blood composition were observed.
Similarly, pregnant rats fed high doses of zinc oxide had increased
stillbirths, and effects on the growth of their young were observed. Some
mutagenicity studies using line oxide and zinc chloride showed positive
results.
Dietary Exposure
Zinc salts as pesticides have no food uses. The Food and Drug
Administration lists zinc salts as "generally recognized as safe" for use in
food as dietary supplements and as nutrients.
Occupational and Residential Exposure
Although there is the potential for significant eye, inhalation and
dermal exposure among mixers, loaders and applicators of zinc salt
products, EPA finds no reason to expect that reasonable use of these
pesticides will constitute any hazard beyond ordinary exposure to zinc
salts. The Agency believes that the use of these pesticides does not
represent an unreasonable hazard to these workers. Zinc salt labels must
continue to reflect any eye or skin hazards, and must continue to
recommend appropriate protective equipment including' protective eyewear,
long-sleeved shirts and long-legged pants, rubber gloyes, and boots.
2
-------
Human Risk Assessment
EPA has no reason to expect that appropriate use of pesticide
products containing zinc salts will constitute any hazard beyond that
presented by ordinary exposure to zinc from non-pesticidal sources.
Although some positive mutagenicity studies have been reported, there is
no indication that such effects result in normal living organisms from
everyday exposure. The Agency has no significant exposure concerns
other than those addressed by existing label precautions for eye and skin
protection of mixers, loaders and applicators.
Environmental Environmental Fata
Assessment Any toxicity associated with zinc can be attributed to the presence of
"free" zinc, and not to total zinc concentration. When zinc salt pesticides
are used outdoors, the zinc in these products binds to and is immobilized in
soil. Use of these products, therefore, does not significantly increase the
amount of "free" zinc in the environment.
Ecological Effects
Zinc is relatively non-toxic to bird populations and is used as a feed
additive for animals. Considering the limited, outdoor use patterns of the
zinc salts, and considering that relatively small amounts are used, it is
unlikely that toxic amounts of zinc will be available to birds or other non-
target animal and insect populations. Although some studies show that zinc
may be highly toxic to aquatic organisms, other studies do not. The
assessment of the risk posed to aquatic organisms resulting from the
industrial preservative {carpet fiber) use is under the purview of the
Agency's Office of Water. Therefore, EPA finds that the zinc salts
products as registered pose no unreasonable risk to the environment.
Environmental Assessment
EPA has concluded that adding zinc to the environment through use
of currently registered pesticides that contain zinc salts will not result in a
significant increase in "free" zinc. Further, little exposure to non-target
species is expected, due to the small-scale outdoor use of these products.
EPA finds that the registered zinc salt pesticides pose no unreasonable risk
to the environment.
Additional Data EPA is requiring additional generic studies on physical chemistry as
Required confirmatory data. In addition, product-specific studies on product
chemistry and acute toxicology must be submitted prior to reregistration.
3
-------
Product Labeling
Changes Required
Regulatory
Conclusion
For More
Information
The labels of the zinc salt products must comply with EPA's current
pesticide labeling requirements. In addition, the industrial preservative
product must bear the following ecotoxicity statement:
"This pesticide is toxic to fish and aquatic invertebrates. Do not
discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or public waters unless this product is specifically
identified and addressed in an NPDES permit. Do not discharge this
product into sewer systems without previously notifying the sewage
treatment plant authority. For guidance, contact your State V&ter
Board or Regional Office of U.S. EPA."
• The registered pesticidal uses of zinc salts are not likely to cause
unreasonable adverse effects in people or the environment, and are eligible
for reregistration.
• Registered products containing one of the zinc salts as the sole
active ingredient will be reregistered once EPA receives and accepts
confirmatory generic data, product-specific data and amended labeling.
• The registered product containing one of the zinc salts as well as
another active ingredient will be reregistered once EPA receives and
accepts confirmatory generic data, product-specific data and amended
labeling, and once EPA completes an eligibility decision on the other active
ingredient,
EPA is requesting public comments on the Reregistration Eligibility
Document (RED) for zinc salts during a 60-day time period, as announced
in a Notice of Availability published in the Federal Register. To obtain a
copy of the RED or to submit written comments, please contact the Public
Response and Program Resources Branch, Field Operations Division
-------
United States Office of Prevention, Pesticides
Environmental Protection And Toxic Substances September 1392
Agency (H-7508W!
oEPA Reregistration
Eligibility Document
(RED)
Zinc Salts
-------
ZINC SALTS REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Jim Saulmon Biological Analysis Branch
Eric Maurer Economic Analysis Branch
Environmental Fate and Effects Division
Katherine Valente Ecological Effects Branch
Sylvia Termes Environmental Fate and Groundwater Branch
Jean Holmes Science Analysis and Coordination Staff
Health Effects Division
Linda Kutney
Pat McLaughlin ¦
Jim Yoweil
Registration Division
Sami Malak
Olga Odiott
Mary Matter
Joanne Miller
Chemical Coordination Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Registration Support Branch
Registration Support branch
Herbicide Fungicide Branch
Herbicide Fungicide Branch
Special Review and Reregistration Division
Bruce Sidwell Accelerated Reregistration Branch
Mark Wilhite Accelerated Reregistration Branch
Policy and Special Projects Staff
Jean Frane Analyst
Office of General Counsel
Jim Curtin Attorney
Office of Compliance Monitoring
Beverly Updike
-------
TABLE OF CONTENTS
EXECUTIVE SUMMARY
I. INTRODUCTION
n. CASE OVERVIEW
A. CHEMICAL OVERVIEW 3
B. USE PROFILE 4
C. REGULATORY HISTORY 5
in. SCIENCE ASSESSMENT OF ZINC SALTS
A. PRODUCT CHEMISTRY ASSESSMENT 6
' B. HUMAN HEALTH ASSESSMENT 6
1. Hazard Assessment
, a. Acute and Subchronic Toxicity 6
b. Chronic Toxicity and Carcinogenicity 8
c. Other Toxicological Effects 9
2- Exposure Assessment
a. Dietary Exposure 10
b. Occupational and Residential Exposure 11
3. Risk Assessment
C. ENVIRONMENTAL ASSESSMENT 11
1. Environmental Fate
a. Environmental Fate and Transport 11
b. Environmental Fate Assessment 12
2. Ecological Effects
a. Ecological Hazard 12
b. Ecological Effects Risk Assessment 13
i
-------
IV. RISK MANAGEMENT AND REREGISTRATION DECISION FOR ZINC
SALTS
A. DETERMINATION OF ELIGIBILITY 14
B. REGULATORY POSITION 15
V. ACTIONS REQUIRED BY REGISTRANTS
A. ADDITIONAL GENERIC DATA REQUIREMENTS 15
B. PRODUCT SPECIFIC DATA REQUIREMENTS 15
C. LABELING REQUIREMENTS 16
VI. APPENDICES
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 Zinc Salts
APPENDIX D - List of Available Related Documents
APPENDIX 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 Registrant(s) sent this DCI
Attachment E - Cost Share/Data Compensation Forms
ii
-------
APPENDIX 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 - EPA Grouping of End Use Products for meeting Acute
Toxicology Data Requirements.
Attachment E - EPA Acceptance Criteria
Attachment F - List of all Registrant(s) sent this DCI
Attachment G - 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
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
HDT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of water or
feed, e.g., mg/1 or ppm.
LDJ0 Median Lethal Dose. A statistically derived single dose that can be expected
to cause death in 50% of the test animals when administered by the route
indicated (oral, dermal, inhalation). It is expressed as a weight of substance
per unit weight of animal, e.g., mg/kg.
Ldlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
MP Manufacturing-Use Product
Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
Not Applicable
NPDES National Pollutant Discharge Elimination System.
iv
MRID
N/A
-------
GLOSSARY OF TERMS AND ABBREVIATIONS (cont.)
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
ppm Parts Per Million
TD Toxic Dose, The dose at which a substance produces a toxic effect
TC Toxic Concentration. The dose at which a substance produces a toxic effect
v
-------
EXECUTIVE SUMMARY
The active ingredients covered in this document include zinc chloride, zinc oxide and
zinc sulfate monohydrate (hereafter referred to as zinc sulfate). Products containing these
active ingredients are used as herbicides, fungicides and bacteriostats for the control of moss,
mildew and fungi on structures and adjacent outdoor areas, in carpet, and in pressure treated
lumber. This Reregistration Eligibility Document (RED) addresses the eligibility for
reregistration of products containing these active ingredients for the above mentioned use
sites only.
Formulations for zinc oxide include an end use industrial preservative for
incorporation into nylon carpet fibers to inhibit bacterial and fungal spoilage, a powder for
control of moss growth on walkways, patios and ornamental lawn use; a metal strip attached
to roofs where it releases soluble oxide which inhibits moss growth; and an ingredient for
pressure treatment of lumber. Zinc chloride is formulated as a solution or soluble concentrate
for application to walkways and patios for control of moss. Zinc sulfate is formulated as a
soluble concentrate also for control of moss on and around buildings.
¦ The U.S. EPA (hereafter referred to as "the Agency") has determined that the uses of
these three active ingredients as they are currently registered will not cause unreasonable risk
to humans or the environment. Therefore the zinc salts are eligible for reregistration. The
Agency is requiring additional studies on physical chemistry as confirmatory data and for
purposes of labeling to complete the generic data base.
Before reregistering the products containing these zinc salts, the Agency is requiring
that product specific data and revised labeling be submitted within eight months of the
issuance of this document. These data include product chemistry and acute toxicology
testing. After reviewing these data and any revised labels and finding them acceptable, the
Agency will reregister a product based on whether or not that product meets the requirements
in Section 3(c)(5) of FIFRA.
1
-------
I. INTRODUCTION
Irs 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the registration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to
be completed in nine years. There are five phases to the re registration process. The first
four phases of the process focus on identification of data requirements to support the
reregistration of an active ingredient and the generation and submission of data to fulfill the
requirements. The fifth phase is a review by the U.S. Environmental Protection Agency
{referred to as "the Agency") of all data submitted to support reregistration.
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 FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility
of the registered uses of zinc chloride, zinc oxide and zinc sulfate. The document consists of
six sections. Section I is the introduction. Section II describes these zinc salts, their uses,
data requirements and regulatory history. Section III discusses the human health and
environmental assessment based on the data available to the Agency. Section IV presents the
reregistration decision for zinc salts. Section V discusses the reregistration requirements for
zinc salts. Finally, Section VI is the Appendices which support this Reregistration Eligibility
Document. Additional details concerning the Agency's review of applicable data are
available on request.1
1 EPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OFP Public Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, DC 20460,
2
-------
IL CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Reregistration Eligibility Document:
o Common Name: Butter of zinc
Chemical Name: Zinc chloride
CAS Registry Number: 7646-85-7
Office of Pesticide Programs Chemical Code: 087801
Empirical Formula: ZnCl2
o Common Name: Flowers of zinc; philosopher's wool; zincite (mineral); zinc white
Chemical Name: Zinc oxide
CAS Registry Number: 1314-13-2
Office of Pesticide Programs Chemical Code: 088502
Empirical Formula: ZnO
o Common Name: Dried zinc sulfate
Chemical Name: Zinc sulfate monohydrate
CAS Registry Number: 7446-19-7
Office of Pesticide Programs Chemical Code: 527200
Empirical Formula: ZnS04 H20
3
-------
B. Use Profile
The following is information on the current registered uses with an overview of use sites and
application methods. A detailed table of these uses of zinc chloride, zinc oxide and zinc
sulfate is in Appendix A.
For zinc chloride:
Type of Pesticide; Herbicide and preservative
Use Sites: Terrestrial non-food, Outdoor residential
Target Pests: Moss, fungi
Formulation Types
Registered: Soluble concentrate - 6.2% zinc chloride
Ready to use liquid -26% zinc chloride
Method and Rates
of Application: Equipment - Hose-end sprayer; non-aerosol pump; tank type
sprayer, sprinkler can.
Method and Rate - Apply (sprinkle or spray) 3 gallons per 100
sq.ft.
Timing - When needed.
For zinc oxide:
Type of Pesticide: Fungicide, herbicide, bacteriostat
Use Sites: Terrestrial non-food, outdoor residential, indoor non-food
Target Pests; Moss, fungi, bacteria
Formulation Types
Registered: Wettable powder- 20.76% zinc oxide;
Metal strip- 99.1% zinc
Powder- 99% zinc oxide (formulation intermediate)
Powder-99.4% zinc oxide (industrial preservative)
Method and Rate
of Application: Equipment - sprinkler can (for wettable powder); galvanized
nails (for metal strip)
4
-------
Method and Rate - Dissolve 1 lb. in 5 gallons of water. For
metal strip, apply along all roof peaks using galvanized or
aluminum nails.
Timing - When needed.
For zinc sulfate:
Type of Pesticide:
Use Sites:
Target Pest:
Formulation Types
Registered:
Method and Rates
of Application:
Herbicide
Terrestrial non-food, Residential outdoor
Moss
Wettable powder- 99% zinc sulfate monohydrate
Equipment - Apply by hand or use sprinkling can or pump-type
sprayer.
Method and Rate - Apply as a powder along the ridge of the
roof; dissolve in 5-10 gallons of water to cover 600 sq, ft. for
gravel or paved surfaces.
Timing - When needed.
C. Regulatory History
Pesticidal products containing zinc salts were first registered in the United States in
1973. The uses include moss control in areas where moss growth is profuse due to high
precipitation rates, primarily in the Northwestern U.S. Zinc oxide is also incorporated into
carpet fibers as a bacteriostatic and fungistatic agent and as an ingredient in a solution for
pressure treatment of wood.
The major use of zinc salts in the United States is non-pesticidal, as a fertilizer
micronutrient. Other uses include as an electrolyte in dry cell batteries, as an animal feed
additive, as a galvanizer and as an emulsion-breaker.
HI. SCIENCE ASSESSMENT OF ZINC SALTS
The Agency has conducted a thorough review of the scientific data base for zinc salts
for the purposes of determining the reregistation eligibility of these pesticides. These
finding are summarized below. The complete references cited in the text are in the
Bibliography (Appendix C).
5
-------
A.
Physical Chemistry Assessment
Zinc chloride is a clear, very deliquescent salt. It has a boiling point of
260°C and at room temperature it is completely soluble in water. The vapor pressure
is 1.5 mmHg and the pH is 5.4. Outstanding generic physical chemistry data
requirements are listed in Section V,
Zinc oxide is an odorless white or yellowish-white powder. It has a melting
point of 2010°C and its density is 0.481 gm/cmJ. It is relatively insoluble in water,
has a pH of 7.37 and is stable.
Zinc sulfate monohydrate is an odorless white solid. It has a melting point of
6Q0°C and a density of 1.121 gm/emJ. It is soluble in water up to 35% and is stable.
Additional physical chemistry data requirements are listed in Section V
Zinc metal is an odorless bluish-white lustrous solid. It has a melting point of
419°C and a density of 7.169 gm/cm5. It is insoluble and has a low stability in the
natural environment, easily forming the solid phases ZnO, Zn(OH), and Zn.O, and
soluble zinc ions.
B. HUMAN HEALTH ASSESSMENT
1. Toxicology - Data Base
The toxicological data base on zinc oxide, zinc chloride, and zinc
sulfate is adequate and will support reregistration eligibility.
a. Acute Toxicity
Zinc oxide:
ACUTE TOXICITY VALUES
TEST
RESULT (mg/kg)
TOXICITY 1
CATEGORY :i
Oral LD50~rat
>5000
'i
iv ;j
Dermal LD50—rabbit
>5000
hi i
Eye effects—rabbit
mild irritant
hi ,
Skin effects-rabbit
non-irritant
IV J
6
-------
The TDlo was reported as 6846 mg/kg in an oral test in rats (1).
An oral LD50 in mice was reported as >7950 mg/kg (2). One report
states that 500 mg applied for 24 hours produced mild irritation on skin
or eyes of rabbits. A TClo reported for human inhalation was 600
mg/m3 of zinc oxide (1).
Zinc chloride:
acute toxicity values
TEST
RESULT (mg/kg)
TOXICITY
CATEGORY
Oral LD50—rat
350
II
Inhalation LClo-human
4800 mg/m3/30mm
III
Eye effects
Corrosive
I
Skin effects
Corrosive
I
Acute oral tests found the LD50 was 350 mg/kg in rats and in
mice, and 200 mg/kg in guinea pigs (1). The human TClo for
inhalation has been reported as 4800 mg/m3/30 minutes (1),
Zinc sulfate:
ACUTE TOXICITY VALUES
TEST
RESULT (mg/kg)
TOXICITY
CATEGORY
Oral LD50--rat
>2949
III
Eye effects—rabbit
severe irritation
I
Skin effects
very slight irritation
IV
Acute oral tests found the LDlo was 333 mg/kg in rats and 2000
mg/kg in rabbits; the LD50 was >2949 mg/kg in rats and 1891
mg/kg in mice (1, 2). Another acute oral study found the LD50
was 1374 mg/kg in rats (3). The oral TDlo for humans is
reported to be 45 mg/kg/7 days (continuous), 106 mg/kg, and
180 mg/kg/6 weeks (intermittent) (1, 2). A dermal irritation
study in rabbits with 99% zinc sulfate found very slight
irritation. In one study, severe irritation was found when 0.09g
of 99% zinc sulfate was applied to rabbit eyes. In another study,
7
-------
the application of 420 ug zinc sulfate to the rabbit eye found
moderate irritation (1).
b. Subchronic Toxicity
There was no evidence of toxicity in humans fed 10 mg/kg/day
of zinc sulfate for up to 3 months (3).
c. Metabolism
Zinc is an essential element in human nutrition and is involved
in the nutrition of all plants and animals. It is an integral component of
several metalloenzymes in various metabolic systems and is present in
every cell (3). In test animals, 8-10 percent of ingested zinc was
absorbed in the intestine and the rest excreted in the feces (3).
Ingestion of large amounts of zinc salts induces a variety of
metabolic changes, with inhibition of some enzymes, effects on
excretion, and a reduction in size and hemoglobin content of red blood
cells (microcytic hypochromic anemia) (3).
It has been calculated that the consumption of zinc salts added to
food may be 0.50 mg of elemental zinc per person per day and the
intake of zinc occurring naturally in food may be 5 to 22 mg per day
(3).
d. Chronic Toxicity, Carcinogenicity
In some long-term studies, extending for one year and over
three generations of rats, zinc chloride, oxide, and sulfate showed no
effects at levels up to 0.25 percent of the diet (3). In other studies,
zinc sulfate caused hematological changes in rats and dogs fed about
100 ppm in the diet (3).
No evidence of carcinogenicity was found in feeding zinc oxide
(at 34.4 mg zinc per day) to rats for 29 weeks. Carcinogenicity has
been reported in mice given zinc chloride in drinking water, but the
reports were not complete and controls were not used consistently. In
another report, mice given up to 5.000 ppm of zinc as zinc sulfate in
drinking water showed no evidence of carcinogenicity and no
differences between treated and control groups (3).
8
-------
e. Reproductive and Developmental Toxicity
When 6846 mg/kg of zinc oxide was given to pregnant rats on
days 1-22 of pregnancy, there were increased stillbirths and effects on
growth of the young (2),
When rats were given 333 mg/kg zinc sulfate orally on days 1-
18 of pregnancy, there was post-implantation mortality (2). Teratologic
studies with oral zinc sulfate in three species of animals were negative
for effects on pregnancy, maternal or fetal survival, or abnormalities.
In these studies mice were given up to 30 mg/kg day for days 6-15 of
gestation, rats were given up to 42.5 mg/kg/day for days 6-15 of
gestation, and hamsters were given up to 88 mg/kg/day for days 6-10
of gestation (3),
f. Mutagenicity
Positive results with zinc oxide have been reported in some
studies. DNA damage in Escherichia coii occurred at 3000 ppm, and
unscheduled DNA synthesis occurred in guinea pigs after exposure to
5300 ug/mV3 hours/6 days in an inhalation study (1, 2).
Positive results with zinc chloride also have been reported in
several studies. Mutagenic effects were seen at 90 mmol/L in a
microsomal mutagenicity assay with Salmonella ryphimurium.
Unscheduled DNA synthesis in human lymphocytes occurred at 180
umol/L and at 360 umol/L. DNA inhibition was seen in human
lymphocytes. In cytogenetic analyses, effects were seen in mice treated
orally with 18 g/kg for 30 days and in human lymphocytes treated with
300 umol/L. Effects also were seen in a host-mediated assay with mice
and Salmonella ryphimurium at 6 mg/kg and at 180 umol/L in an
oncogenic transformation assay using hamster embryos (1).
Positive results have been seen with zinc sulfate in some studies,
including a Drosophila melanogaster sex chromosome assay with an
oral 5mmol/L dose and a mutation assay with Saccharomyces cerevisiae
at 100 mmol/L. DNA inhibition was seen in human He La cells at 1
umol/L/4 hours and oncogenic transformation occurred at 200 umol/L
with hamster embryo (1,2).
9
-------
2. Dietary Exposure
There are no pestieidal food uses for zinc. Zinc is widely
distributed in plants, animals and food, and is a normal part of
metabolism in all living organisms.
The Food and Drug Administration lists these zinc salts as
generally recognized as safe for use in food as dietary supplements and
as nutrients: zinc oxide in 21 CFR 182,5991 and 182.8991, zinc
chloride in 21 CFR 182.5985 and 182.8995, and zinc sulfate in 21
CFR 182.5997 and 182.8997.
3. Occupational and Residential Exposure
The toxieologieal data base on these zinc salts is adequate and will
support reregistration. Therefore, no new exposure data are necessary.
Based on the application methods (specified and implied) and the
formulation types, the potential for significant eye, inhalation and
dermal exposure to concentrated solutions or dusts exists for mixers,
loaders, and applicators. Accordingly, the zinc salt labels must
consistently reflect any potential eye and skin hazard (Danger, Warning
or Caution Signal Words) and recommend appropriate protective
equipment (protective eyeware [goggles or face shield], long sleeved
shirts and long-legged pants, waterproof gloves, shoes and socks).
However, there is no reason to expect reasonable pesticide usage to
constitute any hazard beyond ordinary nan-pestieidal exposure to zinc
salts if label directions are followed, and the Agency believes that the
uses of these products do not represent an unreasonable hazard to
workers.
4, Risk Assessment
The toxieologieal data on these zinc salts in public literature are
adequate for assessing risk to humans. Accordingly, additional studies
are not required for the reregistration of present uses of these salts.
Although some positive mutagenicity studies have been reported, there
is no indication of mutagenic effects in normal living organisms from
everyday exposure. Living organisms have long been exposed to the
components of these zinc salts without such exposure being attributed to
10
-------
mutagenicity. Zinc is widely distributed in plants, animals and soils and
is normally present in food. Zinc is a normal part of metabolism in all
living organisms. These zinc salts are also added ingredients in foods.
There is no reason to expect appropriate pesticide usage to
constitute any hazard beyond ordinary exposure from non-pesticidal
sources. There are no significant exposure concerns other than those
addressed by appropriate label precautions for eye and dermal
protection for the mixers, loaders, and applicators. Refer to section V
for product labeling requirements.
Environmental Assessment
1. Environmental Fate
The Agency is relying on data available in the scientific
literature to assess the environmental fate and transport of zinc salts as
used in pesticidal compounds. No data were submitted by registrants.
a.. Environmental Fate and-Transport
Zinc chloride and zinc sulfate are very soluble in water;
zinc oxide is relatively insoluble. The dissolution of zinc
compounds in water results in the formation of various species
of zinc ions which, in the absence of complex ing or chelating
agents, is dependent on pH. Zinc oxide is less soluble than zinc
chloride or zinc sulfate, but dissolves in more acidic media to
form ZnOH+ and [Zn(H20)6]J+ . In a more basic pH, zinc oxide
dissolves to form [Zn(OH),]' and [Zn(OH)4]2. In natural waters
(both freshwater and seawater), identification of which species
of zinc ion is present is difficult due to the presence of organic
and inorganic natural complexing agents.
Based on calculations using equilibrium constants and in
the absence of organic complexing agents, [Zn(H20)6}]2+»
ZnOH+ and Zn(OH)2 are the predominant species in freshwater.
Zn-chloro complexes may also be present in seawater.
The availability of zinc to plants and other organisms in
soil decreases with increased soil pH. Several components of
soil (clay minerals, mineral oxides and hydroxides, carbonates
and organic matter) can absorb zinc (predominantly as ZnOH').
Zinc therefore can be considered as relatively immobile in most
11
-------
b. Environmental Fate Assessment
Zinc is necessary to alt forms of life and any toxicity
associated with zinc can be attributed to the presence of "free"
zinc and not to total zinc concentration. The Agency has
concluded that the addition of zinc to the environment in the
form of zinc salts used as pesticides will not result in a
significant increase in "free" zinc. This conclusion is based on
indications that "free" zinc is immobilized by various organic
and inorganic substances and by formation of insoluble phases,
thereby making it less bioavailable. Therefore, the terrestrial use
of the pesticidal products containing the zinc salts covered in
this document is not likely to result in the movement of "free"
zinc in soils, and there are no additional environmental fate data
required for the reregistration of the zinc salts.
2. Ecological Effects
Ecological effects data have been submitted for zinc oxide only.
Published information also was used by the Agency to assess the risk
posed by the use of pesticides containing zinc to non-target organisms.
a. Ecological Hazard
1. Ecological Effects Data
Avian toxicity studies were submitted by registrants.
Since most of the applied zinc salts will transform (or become
immobile in soil) to zinc oxide/hydroxide, and since the use of
these products is on a relatively low volume basis, the avian
studies for zinc oxide are sufficient for the other active
ingredients. An acute oral toxicity study in bobwhite quail
provided an LDS0 of 606 mg/kg. In an acute dietary study in
bobwhite quail, the LCj0 was greater than 5000 ppm. These
studies provide sufficient information to classify the acute
toxicity of zinc salts as slightly to practically non-toxic to birds.
Published studies show that coturnix quail fed a diet containing
1.5% zinc oxide had reproductive effects (4). Mallards fed a
diet of 3,000-12,000 ppm zinc showed decreased feed
consumption and body weight (5) and laying hens showed
decreased egg production, shell strength and hatchability on a
diet containing 20,000 ppm zinc (6).
12
-------
b. Environmental Fate Assessment
Zinc is necessary to all forms of life and any toxicity
associated with zinc can be attributed to the presence of "free"
zinc and not to total zinc concentration. The Agency has
concluded that the addition of zinc to the environment in the
form of zinc salts used as pesticides will not result in a
significant increase in "free" zinc. This conclusion is based on
indications that "free" zinc is immobilized by various organic
and inorganic substances and by formation of insoluble phases,
thereby-making it less bioavailable (). Therefore, the terrestrial
use of the pesticidal products containing the zinc salts covered in
this document is not likely to result in the movement of "free"
zinc in soils, and there are no additional environmental fate data
required for the reregistration of the zinc salts.
2. Ecological Effects
Ecological effects data have been submitted for zinc oxide only.
Published information also was used by the Agency to assess the risk
posed by the use of pesticides containing zinc to non-target organisms.
a. Ecological Hazard
1. Ecological Effects Data
Avian toxicity studies were submitted by registrants.
Since most of the applied zinc salts will transform (or become
immobile in soil) to zinc oxide/hydroxide, and since the use of
these products is on a relatively low volume basis, the avian
studies for zinc oxide are sufficient for the other active
ingredients. An acute oral toxicity study in bobwhite quail
provided an LDS0 of 606 mg/kg. In an acute dietary study in
bobwhite quail, the LC50 was greater than 5000 ppm. These
studies provide sufficient information to classify the acute
toxicity of zinc salts as slightly to practically non-toxic to birds.
Published studies show that coturnix quail fed a diet containing
1.5% zinc oxide had reproductive effects (4). Mallards fed a
diet of 3,000-12,000 ppm zinc showed decreased feed
consumption and body weight (5) and laying hens showed
decreased egg production, shell strength and hatchability on a
diet containing 20,000 ppm zinc (6).
Studies submitted to the Agency, as well as published
12
-------
literature, were used to assess the toxicity of these zinc salts to
non-target organisms in aquatic or estuarine ecosystems;
however, the results were highly variable. The LCW for bluegiil
sunfish was greater than 320 ppm but was 1.1 ppm in rainbow
trout in studies submitted to the Agency, while the 96 hr LCS0
reported in the literature ranged from 1.2-17.9 ppm for
freshwater fish (7,8)- Acute toxicity in Daphnia magna was
greater than 1000 ppm (i.e. practically non-toxic) in a study
submitted to the Agency. Data from the literature were variable,
indicating that zinc may be highly toxic to freshwater
invertebrates (9). However, in two published studies, the 96 hr
LCjo values ranged from 0.25-18,4 ppm in freshwater
invertebrates (7,8). In conclusion, although the data showed
extreme variability of results, at least two of the studies
indicated that zinc oxide may be highly toxic to both freshwater
fish and freshwater invertebrates.
b. Ecological Effects Risk Assessment
Zinc is relatively non-toxic to avian populations
and is used as a feed additive for animals. Given the use
patterns and frequency of application of pesticidal
products containing these zinc salts, it is unlikely that
zinc would be available in toxic amounts to avian or
other non-target animal and insect populations in
terrestrial environments as a result of their use. Although
zinc may be toxic to aquatic organisms in some
environments, based on the environmental fate
assessment, aquatic exposure resulting from the use of
these products is expected to be negligible. Therefore,
the Agency has determined that these products, as they
are currently registered, pose no unreasonable risk to the
environment.
The textile industrial preservative use of zinc
oxide results in indirect discharge of effluent containing
zinc into natural waters. An assessment of the risk posed
to aquatic organisms resulting from this route of
exposure is under the purview of the Agency's Office of
Water and will not be covered in this document.
Although the aquatic toxicity studies showed variability
in results, they are adequate to determine the appropriate
label statements for this industrial preservative. The
required label precaution statement is included in section
V.
13
-------
IV. RISK MANAGEMENT AND REREGISTRATION DECISION FOR ZINC SALTS
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 the active ingredient are eligible for reregistration. The Agency has
completed its review of data from the open literature and generic data submitted by
registrants, and has determined that the data are sufficient to support reregistration of
products containing zinc salts. Appendix B identifies the generic data that the Agency
reviewed as part of its determination of reregistration eligibility of zinc salts, and lists
the submitted studies that the Agency found acceptable.
The data identified in Appendix 8 were sufficient to allow the Agency to
assess registered uses of zinc salts and to determine that these uses can be used
without resulting in unreasonable adverse effects to humans and the environment.
The Agency therefore finds that products containing zinc salts as an active ingredient
are eligible for reregistration. The reregistration of particular products is addressed in
Section V of this document.
The Agency made its reregistration eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data and the data identified in Appendix B.
Although the Agency has found that current products containing zinc salts 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 zinc salts, if new information comes to the
Agency's attention or if the data requirements for reregistration (or the guidelines for
generating such data) change.
The following is a summary of the regulatory positions and rationales for zinc
salts. Where labeling revisions axe imposed, specific language is set forth in Section
V of this document.
Eligibility pggigipn
The Agency has sufficient information on the human health effects of zinc salts
and on its potential for causing effects in fish and wildlife and the environment when
used to control moss and fiingus growth in outdoor residential areas, on structures, in
pressure-treated lumber and incorporated into fibers used in carpet. The Agency
concludes that products containing zinc salts for these uses are eligible for
reregistration. Only certain generic physical chemistry data studies on zinc salts still
are needed as confirmatory information. The Agency has determined that zinc salt
containing products, labeial and used as specified in this Reregistration Eligibility
14
-------
Document, will not pose unreasonable risks or adverse effects to humans or the
environment.
Eligible and Ineligible Uses
The Agency has determined that all registered uses are eligible for
reregistration at this time.
B. Regulatory Position
Tolerances and Action Levels
There are no registered food uses or tolerances for products containing zinc
salts as an active ingredient.
V. ACTIONS REQUIRED BY REGISTRANTS
This section is designed to assist the registrant by providing data requirements and
responses necessary for the reregistration of manufacturing-use and end-use products.
A. Additional Generic Data Requirements
The generic data base supporting the reregistration of zinc salt-containing
products has been reviewed and determined to be substantially complete. Although
some of the generic product chemistry data requirements are acceptable, additional
data are required as confirmatory. These are part of the generic Data Call-in. These
generic data requirements are listed in Appendix F.
B. Product specific data requirements
1. Additional Product-Specific Data Requirements
Based on the reviews of the generic data for zinc salts, the products containing
zinc salts are eligible for reregistration. Section 4(g)(2)(B) of FIFRA calls for the
Agency to obtain any needed product-specific data regarding the pesticide after a
determination of eligibility has been made. The product specific data requirements
are listed in Appendix G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix G; Attachment E) and if not, commit to
conduct new studies. If the registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for
each product.
15
-------
C. Labeling Requirements for Manufacturing and End-Use Products
End-Use Products
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10. Labels must
consistently reflect any potential eye and skin hazard (Danger, Warning or Caution
Signal Words) and recommend appropriate protective equipment (protective eyeware
[goggles or face shield], long sleeved shirts and long-legged pants, waterproof gloves,
shoes and socks). Please follow the instructions in the Pesticide Reregistration
Handbook with respect to labels and labeling.
Manufacturing use (Includes Industrial Preservatives)
In addition to the above requirements for end-use products, labels and labeling
of all manufacturing use products must contain the following statement:
"This pesticide is toxic to fish and aquatic invertebrates. Do not discharge
effluent containing this product into lakes, streams, ponds, estuaries, oceans or public
waters unless this product is specifically identified and addressed in an NPDES
permit. Do not discharge this product into sewer systems without previously notifying
the sewage treatment plant authority. For guidance, contact your State Water Board or
Regional Office of U.S. EPA."
16
-------
APPENDIX A
Table of Zinc Salts Use Patterns
Subject to Reregistration
-------
Zinc oxide
SiTi Typ*. App*itmtian lining Apfiin^t*ot>
R«f«
Mnemmi
A$f*6atnjn Kai*
Mwn. f Appc
Max. t
Aft** #
Mm i^it
Min Inlwvcl
HaMt-tfMft A+yw.
M«.«
RaatrHilftd
tonrval
igi
U»« iwumm
¦too Mi
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED USES
TEXTILES/TEXTILE FiBERS/CGRDAGf (nylon carpal fiber}
USE GROUP: INDOOR NON-FOOD
Industrial preservative treatment; not on
label; during mnnufacturs.
FNI/S
na
500 pprn Al
by wt.
not
spacifiad
not spec
not spec
not spec
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES USE GROUPIS): OUTDOOR RESIDENTIAL
Dust, shaker can, when needed
WP/D
na
0.4152 lb
Al/JK sq.ft.
no!
specified
not spec
not spec
not spec
Strip treatment, by hand, when neoded
Impr
na
not specified
nol
specified
not spec
not spec
not spec
Sprinkla, watering can, whan needed
WP/D
na
0-4152 lb
AI/1K sq.tt.
not
specified
not spec
not spec
not spec
NON AGRICULTURAL OUTDOOR BUILDINGS/STRUCTURES
US£ GROUP(S): TERRESTRIAL WON FOOD CROP
Dust, shaker can, whan needed
WP/D
na
0.4152 lb
AI/1K sq.ft.
nolspec
not spec
not spec
not spec
Sprinkle, watering can, when neoded
WP/D
na
0.4152 lb
AI/1 K sq.ft.
not spec
not spec
not spec
not spec
NON-AGRICULTURAL RIGHTS-OF-WAY/f-ENCEROWS/HEOGEKOWS USE GROUPSS): TERRESTRIAL NON-FOOD CROP
Dust, shaker can, when needed
WP/D
na
0.41S2 lb
AW IK sq.fl
not spec
not spec:
not spec
not spec
Sprinkle, watering can, when needed
WP/D
na
.4152 lb
AI/1K sq.ft.
nol spec
not spec
not spec
nut spec
PATHS/PATIOS USE GfiOUP(S): TERRESTRIAL NON-FOOD
+ OUTDOOR RESIDENTIAL
Oust, shaker can, when needed
WP/D
na
0.4152 lb
AI/1 K sq.ft.
not spec
not bp«c
not spec
i Hit spec
-------
Zinc oxide
snt Apf)lic*li(jil Tvpf, Affibcaltw
Uininun
All*
Apifliciiun Alia
Mix. t Ap|M
Ma- 1
V
Ut«. Hii<
Min k *«•*«!
Aw*. ^
Mi* H*t*
Hwtiitiwl
Liriiy
Mwil
lD*vl
lAt 1 MlilAhurU
¦Jtu ¦
Ab4M*v>4lLHMl
A|U«,l|
(ki«|lLiiA-*d
Sprinkle, watering can, whan needed
WP/D
na
0.4152 lb
AI/1K sq ft.
not spec
not spec
not spec
no spec
PAVED AREAS [PRIVATE ROADS/SIDEWALKS) USE GROUP(S): TERRESTRIAL NON-FOOD + OUTDOOR RESIDENTIAL
Dust, shaker can, when needed
WP/D
na
0.4152 lb
AI/1K sq.ft.
not spec
not spec
not spec
not spec
Sprinkle, Watering can, when needed
WP/D
na
0.4152 lb
AI/1 K sq.ft.
not spec
not spec
not spec
not spec
ORNAMENTAL LAWNS AND TURF USE GROUP(S): OUTDOOR RESIDENTIAL
Dust, shaker can, when needed
WP/D
na
0.4152 ib
AI/1 K sq.ft.
not spec
not spec
not spec
not spec
Sprinkle, watering can, whan needed
WP/D
na
0.4152 Ib
AI/1 K sq.lt.
not spec
not spec
not spec
not spec
Abbreviations used
Header: form - formulation; max. # app, = maximum number of applications;
Form: FNI/S =¦ Form Not Identilied/Solid WP7D - Wettable Powder/Dust; Impr - Impregnated Material;
Rate: na = not applicable
Limitations: Do not discharge effluent containing this pesticide into sewage without notifying the sewage treatment plant authority.
(524-354} Do not discharge effluent containing this pesticide into lakes, streams, ponds, estuaries, oceans, or public water. INPDES License restriction J
Zinc chloride
SJTE lyp*, AppkcaUun Timr^, AfflktlW h>fim*nt
Mifkn^m Apfilicalion
ft
Mnonwm.
ApphcaOtxi Hti«
Mn t *+*>•
Ma- t
Av,h, $
Mia HiI«
Mir, b-sluH vo-l
JhlwiMi (E^1
IlkCl
Lurlm,
r
0.
AfcJ>j*Av('! CdkllUlClJ
not
not spec
not spec
^[irfiy. nwri hir-r h j ^(tl pump. >vh<;n n:-r*JcJ
. M-.
r,('l
nut
r II I
run spnt:
llul l;<;
-------
Zinc chloride
SfTt Tfl», Application l]niing, Afflitlliw
'turn A^cMon
Af*jJw«twn Raia
Mm. kilwval
A44M
M»*. R*i*
MAh 1*4 Nuit
spray, tank-type sprays whan needed
SC/L
dose cannot
be calculated
sprinkle, sprinkler can, when needed
SC/L
dose cannot
be calculated
not
specified
not
specified
not spec
not spec
, not
specified
not
specified
not spec
not spec
NON-AGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS USE GROUP{S|: TERRESTRIAL NON-FOOD CROP
spray, non-aerosol pump, when noadad
L/RTU
not specified II not spec
not spec
not spec
not spec
PATHS/PATIOS USE GROUP1SJ: OUTDOOR RESIDENTIAL
spray, hose-end sprayer, when needed
SC/L
dose cannot
be calculated
not
specified
not spec
not spec
not spue
spray, non-aerosol pump, whan needed
L/RTU
dose cannot
be calculated
not
specified
not spec
not spec
not spec
spray, tank-type sprayer, when needed
SC/L
dose cannot
be calculated
not spec
not spec
not spec
not spec
PAVED AREAS (PRIVATE ROAD/SIDEWALKS) USE GROUPfS): OUTDOOR RESIDENTIAL
spray, hose-end sprayer, when needed
SC/L
dose cannot
be calculated
not spec
not spec
not spec
not spec
spray, non-aerosol pump, when needed
L/RTU
dose cannot
be calculated
not spec
not spec
not spec
not spec
spray, tank-type sprayer, when needed
SC/L
dose cannot
be calculated
not spec
noi spec
not spec
not *jpno
sprinkle, sprinkler-can, when needed
SC/L
dose cannot
be calculated
not spec
not spec
not spec
not spec
Abbreviations used
Header: form = formulation; not spec = not specified
Form: SC/L = Soluble Concentraie/Liquid; L/RTU ^ Liquid/Ready to Use;
Rate: ria - not applicable;
-------
Zinc sulfate monohydrate
Sflfc Anpbc«(ian Typo, Appiisabon i^ufMpini
Fait
Minimum
ft»r*
AptAcafaiwi ft«i«
Mux t
Ma* I
***>¦• 9
Mra« K»t#
Mill Hews!
felt***., A*,* |)
Mm fi»«*
bilry
bir*tv»J
liwejrg^
lO»v»fr
ANuwwii
USES ELIGIBLE FOR REREGISTRATtON
NONFOOD/NONFEED USES
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES USE GROUP(S): OUTDOOR RESIDENTIAL
Spray, hydraulic sprayer, whan needed
WP/D
na
KS lb /IK
sq.1t
nolspec
nor spec
not spac
not spec
Spray, sprinkler can, when needed
WP/D
na
same
not spac
not spec
rtot spec
not spec
spray, tank type sprayer, when needed
WP/D
na
same
not spec
not spec
not spac
not spec
Sprinkle, package applicator, when
needed
WP/D
na
same
not spec
nol spec
not spec
not spec
PATHS/PATIOS (PRIVATE ROADS/SIDEWALKS) USE GROUP(SS: TERRESTRIAL WON FOOD + OUTDOOR RESIDENTIAL
Spray, hydraulic sprayer, whan needed
WP/D
na
same
not spas
not spec
not spec
no? spec
spray, sprinkler can, when needed
WP/D
na
same
not spec
not spec
not spec
not spec;
Spray, tank-type sprayer, when needed
WP/D
na
same
nolspec
not spec
not spec
not spec
Sprinkle, package applicator, whan
needed
WP/D
na
same
not spec
not spec
not spec
not spec
PAVED AREAS (PRIVATE ROADS/SIDEWALKS) USE GRQUP(S): OUTDOOR RESIDENTIAL
Spray, sprinkler can, when needed
WP/D
na
same
not spec
not spec
not spec
not spec
Spray, tank-type, when needed
WP/D
na
same
not spec
not spec
not spec
not spec
Sprinkle, package applicator, when
needed
WP/D
na
same
not spec
not spec
not spec
not spec
Spray, hydraulic sprayer, when needed
WP/D
na
same
not spec
not spec
not spec
nol spec
. k bh re vi aliens used
Header: not spec = not specified;
Form: WP/Q = Wettable Powder/Dust;
Rate: Zinc standardized dose = 1 8 lb/1 K sq.ft represents tha available metallic zinc, however, it is neither active inyrK.lieur aai product; na = ir.» spprieuijb;
-------
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 the
zinc salts covered by this Reregistration Eligibility document. It contains generic data
requirements that apply to zinc salts in all products, including data requirements for which a
"typical formulation" is 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 set 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 citation (Column 3). If the Agency has acceptable data in its files, this
column 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.
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Zinc Salts
Requirement Use Pattern Citation
ZINC CHLORIDE
§158.120
61-1
Product Chemistry
Chemical Identity
All
41758802
61-2
Beginning Materials and
Manufacturing Process
All
41758802
61-2
Formulation of Impurities
All
41758802
62-2
Certification of Limits
Ail
DATA GAP
62-3
Analytical Methods
Ail
DATA GAP
63-2
Color
All
41758802
63-3
Physical State
All
41758802
63-4
Odor
Ail
41758802
63-6
Boiling Point
Ail
41758802
63-7
Density
All
42261001
63-8
Solubility
All
41758801
63-10
Dissociation Constant
Ali
41758801
63-12
pH
All
DATA GAP
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Zinc Salts
Requirement Use Pattern Citation
§158,130 Environmental Fate
All environmental fate data requirements have been waived,
§158.135 Toxicology
All data toxicity data requirements have been waived.
§158.145 Ecological Effects
All ecological effects data requirements have been waived.
ZINC OXIDE4
All 41777901,41672401
41673701, 42126501
All 41777901,41672401
41673701, 42126501
§158.120 Product Chemistry
61-1 Chemical Identity
,61-2 Beginning Materials and
" Manufacturing Process
'Although there are no data gaps listed for zinc oxide, there are some confirmatory data requirements for individual registrants.
These are addressed in the generic data call in as appropriate.
-------
APPENDIX B
Data Supporting Guideline Requirements for the Registration of Zinc Salts
Requirement
Use Pattern
Citalion
61-2 Formulation of Impurities
62-3 Analytical Methods
All
41777901, 41672401
41673701, 42126501
41777902, 42126502
63-2 Color
41777903, 41672401
41673701, 42126503
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-7 Density
63-8 Solubility
63-10 Dissociation Constant
63-12 pH
All
All
All
All
All
All
41777903, 41672401,
41673701, 42126503
41777903, 41672401
41673701, 42126503
41777903, 41672401
41673701, 42126503
41777903,41672401
41673701, 42126503
41777903, 41672401
41673701, 42126503
41777903
41777903, 42126503
-------
APPENDIX B
Data Supporting Guideline Requirements for the Re registration of Zinc Salts
Requirement
Use Pattern
Citation
§158.130 Environmental Fate
All environmental fate data requirements have been waived. Refer to section III.C.
§158.135 Toxicology
81-1 Acute oral toxicity All
81-2 Acute dermal toxicity All
81-3 Acute inhalation All
81-4 Primary eye irritation AH
81-5 Primary dermal irritation All
81-6 Dermal sensitization All
84-2 Structural Chromosomal Aberration All
84-4 Other Genotoxic Effects All
§158.145 Ecological Effects
71-1 Acute Avian Oral Toxicity - Quail/Duck All
71-2 Avian Dietary Toxicity - Quail/Duck All
72-1 Freshwater Fish Toxicity Bluegill/Trout All
147624
147625
WAIVED
147627
147626
WAIVED
WAIVED
WAIVED
155226
155225
155224, 155228
-------
APPENDIX R
Data Supporting Guideline Requirements for the Registration of Zinc Salts
Requirement Use Pattern ; Citation
72-2
Freshwater Invertebrate Toxicity
All
155227
§158.
61-1
120 Product Chemistry
Chemical Identity
ZINC SULFATE MONOHYDRATE
All
42233802
61-2
Beginning Materials and
Manufacturing Process
All
41758802
61-2
Formulation of Impurities
All
41758802
62-1
Preliminary Analysis
All
DATA GAP
62-2
Certification of Limits
All
DATA GAP
62-3
Analytical Methods
All
DATA GAP
63-2
Color
All
41758802
63-3
Physical State
All
41758802
63-4
Odor
All
41758802
63-6
Boiling Point
All
41758802
63-7
Density
All
42261001
-------
APPENDIX B
Data Supporting Guideline Requirements for the Registration of Zinc Salts
Requirement
Use Pattern
Citation
63-8 Solubility
63-10 Dissociation Constant
63-12 pH
§158.130 Environmental Fate
All environmental fate data requirements have been waived,
§158.135 Toxicology
All data toxicity data requirements have been waived.
§158.145 Ecological Effects
All ecological effects data requirements have been waived.
All
All
All
41758801
41758801
42261001
-------
APPENDIX C
ZINC SALTS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting the Reregistration of Zinc Salts
-------
GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY, This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included,
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY, In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the first
submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced the
date from the evidence contained in the document. When the date appears as
(19??), the Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
-------
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission;
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the submitter. 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.
-------
VfRID
APPENDIX C
ZINC SALTS BIBLIOGRAPHY
CITATION
00155224 McAllister, W.; Bowman, J.; Cohle, P, (1985) Acute Toxicity of Zinc Oxide to
Bluegill Sunfish {Lepomis macrochirus)'.Static Acute Toxicity Report No.
AB-85-134 prepared by Analytical Bio-chemistry Laboratories Inc.
00155225 Beavers, J,; (1985) Zinc Oxide; A Dietary LC}„ Study with the Bobwhite: Final
Report Project No. 139-224. Unpublished study prepared by Wildlife
International Ltd.
00155226 Beavers, J, (1985) Zinc Oxide: An Acute Oral Toxicity Study with the Bobwhite;
Final report Project No. 139-224. Unpublished study prepared by Wildlife
International Ltd.
00155227 Forbis, A.; Georgie, L.; Burgess, D. (1985) Acute Toxicity of Zinc Oxide to
Daphnia magna: Static Acute Toxicity Report No. 33229. Unpublished
Monsanto Study No. AB-85-136 prepared by Analytical Bio-Chemistry
Laboratories, Inc.
00155228 McAllister, W.; Bowman, J.; Cohle, P. (1985) Acute Toxicity of Zinc oxide to
Rainbow Trout (Satmo gairdneriy. Static Acute Toxicity Report No.
33228. Unpublished Monsanto Study no. AB-85-135 prepared by
Analytical Bio-Chemistry Laboratories Inc.
41672401 Waltz, D. (1990) Product Chemistry of Zinc Oxide. Unpublished study prepared
by David Waltz Imports.
41758801 Klettke, M.; (1991) Product Chemistry; Zinc Chloride. Unpublished study
prepared by Chas. H. Lily Corp.
41758802 Klettke, M.; (1991) Product Chemistry: Zinc Chloride, Unpublished study
prepared by Chas. H. Lily Corp.
41777901 Geiselman, S. (1991) Phase 3 Submission of Zinc Oxide: Product Identity and
Composition. Unpublished study prepared by Monsanto Corp.
41777902 Geiselman, S. (1991) Phase 3 Submission of Zinc Oxide: Analysis and
Certification of Product Ingredients. Unpublished study prepared by
Monsanto Corp,
41777903 Geiselman, S. (1991) Phase 3 Submssion of Zinc Oxide; Physical and Chemical
Characteristics. Unpublished study prepared by Monsanto Corp,
-------
APPENDIX C
zinc: salts bibliography
MRID
CITATION
42126501 Palmer, E. (1991) Product Chemistry Studies for Zinc Oxide. Unpublished study-
prepared by American Chemet Corp.
42126502 Palmer, E, (1991) Product Chemistry Studies for Zinc Oxide, Unpublished study
prepared by American Chemet Corp.
42126503 Palmer, E. (1991) Product Chemistry Studies for Zinc Oxide. Unpublished study
prepared by American Chemet Corp.
42233803 Glaza, S. (1988) Primary Eye irritation Study of Zinc Sulfate Monohydrate in
Rabbits. Lab project No. HLA 80200644. Unpublished study prepared by
Hazelton Labs. America, Inc.
42233804 Giaza, S. (1988) Primary Dermal Irritation Study of Zinc Sulfate Monohydrate
in Rabbits. Lab Project No. HLA 80200645. Unpublished study prepared
by Hazelton Labs. America, Inc.
42252501 Mischkot, J. (1991) Physical and Chemical properties of Zinc Sulfate
Monohydrate, Unpublished study prepared by Retta Mfg., Inc.
The following are sources from the open literature cited in this document:
(1) Sax, N.; Lewis, R. (1989) Dangerous Properties of Industrial Materials. 7th
Edition. Van Nostrand Reir.hold. New York.
(2) NIOSH (1987) Registry of Toxic Effects of Chemical Substances. Washington, DC.
(3) FASEB, 1973. "Evaluation of the Health Aspects of Certain Zinc Salts as Food
Ingredients." SCOGS-21.
(4) Hussein, A.; Cantor, A.; Johnson, T. (1988) Use of High Levels of Dietary Aluminum
and Zinc for Induction Pauses in Egg Production in Japanese Quail. Poultry
Science 67:1157-65.
(5) Gasaway, W.; Buss S. (1972) Zinc Toxicity in the Mallard Duck. Journal of Wildlife
Management 36(4): 1107-1117.
(6) Palafox, A.; Ho-A, E. (1980) Effect of Zinc Toxicity in Laying White Leghorn Pullets
and Hens. Poultry Science 59:2024-28.
-------
(7) United States Environmental Protection Agency (1987) Ambient Water Quality Criteria
for Zinc-1987. Office of Water Regulations and Standards, Criteria and Standards
Division. Washington, DC
(8) Hudson, R.; Tucker, R. ; Haegele, M, (1984) Handbook of Toxicity of Pesticides to
Wildlife. 2nd ed. United Satates Fish and Wildlife Service, Resource Publication
No. 153, Washington, DC.
(9) United States Atomic Energy, (1973') Toxicity of Power Plant Chemicals to Aquatic Lite.
Compiled by C. Becker and T, Thatcher, Battelle Inc. Richland, WA.
19
-------
APPENDIX D
List of Available Related Documents
The following is a list of available documents related to zinc salts. 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 zinc salts 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. Zinc salts RED Fact Sheet
4. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
2
PR NOTICE 91-2
OFFICE OF
FESTCXESANOTOUC
SUBSTANCES
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS
AND REGISTRANTS OF PESTICIDES
*
ATTENTION: Persons Responsible for Federal Registration of
SUBJECTj Accuracy of Stated Percentages for Ingredients
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient (s), as that term is
defined in 40 CFR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable label
claim for the amount of active ingredient in the product,
II. BACKGROUND
For some time the Agency has accepted two different methods of
identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the. nominal
concentration. Other applicants claimed the lower Unit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the.regulators, and the consumers as to exactly
how much of a given ingredient was in a given product. The Agency
has established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
Current regulations require that the percentage listed in the
active ingredient statement be as precise as possible reflecting
good manufacturing practices 40 CFR 156.10(g)(5). The certified
limits- required for each active ingredient are intended to
encompass any such "good manufacturing practice11 variations 40 CFR
158.175(c)(3).
Pesticide Products
Statement
printed on Recyvtod Paper
-------
The tipper and lower certified limits, which must be proposed in
connection with a product's registration, represent the amounts of
an ingredient that may legally be present 40 CFR 158.175. The lower
certified limit is used as the enforceable lower limit for the
product composition according to FIFRA section 12(a)(l)(C), while
the nominal concentration appearing on the label would be the
routinely achieved concentration used for calculation of dosages
and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual product
composition because the nominal concentration would be the amount
of active ingredient typically found in the product.
It is important for registrants to note that certified limits
for active ingredients are not considered to be trade secret
information under FIFRA section 10(b)• In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing on
the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
11X« KilWUllv£*rlrifi la>
As described below under Unit V. " COMPLIANCE SCHUWI^," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the nominal
concentration expressed as a percentage by weight as the label
claim in the ingredient(s) statement and equivalence statements if
applicable (e.g., elemental arsenic, metallic zinc, salt of an
acid). In addition, the requirement for performing sample analyses
of five or more representative samples must be fulfilled. Copies of
.the raw analytical data must be submitted with the nominal
ingredient label claim. Further information about the analysis
requirement may be found in the 40 CFR 158.170. All products are
required to provide certified limits for each active, inert
ingredient, impurities of toxicological significance(i.e., upper
limit(s) only), and on a case by case basis as specified by EPA.
These limits are to be set based on representative sampling and
chemical analysis(i.e., quality control) of the product.
The format-of the ingredient statement must conform to 40 CFR
156-Labeling Requirements For Pesticides and Devices.
After July l, 1997, all pesticide ingredient statements Bust
l»a changed to nominal concentration.
-------
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lover then the minimum
lev«l to achieve efficacy. This is extremely important for
products vhich are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 158.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to 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 requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reragistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product
registrations submitted to the Agency
are to comply with the requirements of this
Notice.
(2) Registrants having products subject to
reregistration under FIFRA section 4(a) are to
comply with the requirements of this Notice when
specific products are celled in by the Agency
under Phase V of the Reregistration Program.
(3) All other products/applications that are
not subject to (1) and (2) above will have until
July l, 1997, to comply with this Notice.
Such applications should note "Conversion
to Nominal concentration" on the application
form. These types of amendments will not be
handled as "Fast Track" applications but
will be handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 557-5024.
Registration Division (H-7505
-------
APPENDIX F
Generic Data Call-in
-------
-1'
A "j UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
; } WASHINGTON, B.C. 2C460
\ jr
* ;« •**
DATA CALL-IN NOTICE
*p; rs
C5RTIFIS5 Miftll* pest.cdcsano'c.1
SwaSTASCeS
Dear Sir or Madam;
'This Notice requires you and other registrants of pesticide
products containing the active ingredient idantifiad in
Attachment A of this Notice, the Data Call-In Chemical statu*
Sheet, to submit certain data as noted herein to the U.S.
Environmental Protection Agency (EPA, the Agency)» These data
are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days
after you receive this Notice you must respond as set forth in
Section III below, your response must stata:
1. how you will comply with ths requirements set forth in
this Notice and its Attachments A through S; or
2. why you believe you are exempt froa the requirements
listed in tills Notice and in Attachment c, Requirements
Statue and Registrant's Response Fott, (see section
111-8)1 or
3. why you believe EPA should not require your submission
of dat* ilk the manner specified by this Notice (see
section. XZX-D).
If you da not; respond to this Notice, or it you do not
satisfy XV* that you will comply with its requirements or should
be exempt or excused fro* doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension.
We hav* provided a list of all of your products subject to this
Notice In Attachment ® ® well as a
list of *11. registrants who were sent thi» Notice (Attachment D).
The authority for this Notice is section 3 (c) (2) (B) of the
Federal Insecticide, Fungicide and Rodenticids Act as amended
(FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorised under the Paperwork Reduction Act by
rna Approval NO. 2070-0107 (expiration date 12-31-92).
*i«M«ftMcy»"awr
-------
2
This Notice is divided into six sections and five
Attachments* The Notice itself contains information and
instructions applicable to all Data Call-in Notices. The'
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section I - why You Are Receiving This Notice
Section IX - Data Required Sy This Notice
Section III - Compliance With Requirements Of This
Notice
Section IV - Consequences Of Failure To comply With
This Notice
Section V - Registrants* Obligation To Report
Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachs*int A - Sate Call-In Chemical Status Sheet
Attachment B - Data call-in Response Form
Attachment C - Requirements Status And Registrant's Response
Fern
Attachment D - List of All Registrants sent This Data
Call-in Notice
Attachment E - Cost Share And Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. This reevaluation
identified additional data necessary to assess the health and
safety of the continued use of products containing this active
ingredient. You have been sent this Notice because you have
product(a) containing the subject active ingredient.
SECTION XI. DATA REQUIRED BY THIS NOTICE
H~A» jQAX&iJB2S3ZX2ED
The data required by this Notice are specified in
Attachment c, K«nilriitnf Statui and Rtqlitran*'» Rtiponat rprm-
Depending en the results of the studies required in this Notice,
additional testing aay be required.
II-®. samaatx rem atnanssioN or data
Yon are required to submit the data or otherwise satisfy the
date requirements specified in Attachment C, Beoulremants Status
and wm*nonmm Form, within the timeframes provided.
-------
Il-c. TESTING PROTOCOL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal Road,
Springfield, Va 22161 (tel; 703-487-4650).
Protocols approved by the organization for Economic
Cooperation and Development (OECD) are also acceptable if the OECD-
recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CPS $ 158.70). When
using the OECO protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements
of 40 era f 158. normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.w.,
Washington, D.C. 20006*
All new studies and proposed protocols submitted in response
to this Data Call-In notice must be in accordance with Good
Laboratory Practices [40 CFR Part 160.3(a)(6)].
XI-D. REGISTRANTS RECBIVIW PREVIOUS SSCTIOff NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, thll Qata Call-in fl9tl in
anv wav supersede or change the requirements of anv previous Data
Call-infsi. or any other agreements entered into with the Agency
pertaining to sucti prior Notice. Registrants must comply with the
requirements et all Notices to avoid issuance of a Notice of Intent
to Suspend their affected products*
SECTION Iir. eanOT.Tmeg agoonmrnrog of this notice
IX*-*. warn rasgowpiirc to the agency
Th» appropriate responses initially required by this Notice
must to* submitted to the Agency within 90 days after your receipt
of this Notic*. failure to adequately respond; ta this Notice
within to day* of your receipt will be a basis for issuing a Notice
of intent to suspend (H0ZS) afftctinf your products. This and other
bases for issuance of HOIS due to failure to coaply with this
Notice are presented in Section IV-A and IV-B,
-------
4
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary
cancellation, 2) delete use(s), (3) claim generic data exemption,
(4) agree to satisfy the data requirements imposed by this Notice
or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary
Cancellation option, the Delete Use(s) option or the Generic Data
Exemption option is presented below. A discussion of the various
¦options available for satisfying the data requirements of this
Notice is contained in Section III-C. A discussion of options
relating to requests for data waivers is contained in
Section III-D.
There are two forms that accompany this Notice of which,
depending upon your response, on* or both must be used in your
response to the Agency. These forms are the Data-Call-in Response
-Fora. Attachment B and the Requirements Status and Registrant's
Response Form. Attachment C. The Data Call-in Response Form must be
submitted as part of every response to this Notice. Pleas* note
that the company's authorized representative is required to sign
the first page of the Data Call-in Response Form and Retirements
, Status and Registrant's Response Form (if this form is required}
and initial any subsequent pages. The forms contain separate
detailed instructions on the response options. Do not alter the
printed material. If you have questions or need assistance in
preparing your response, call or write the contact person
identified in Attachment A.
1. Voluntary Cancellation - You may avoid the requirements of
this Notice by requesting voluntary cancellation of your product(s;
containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancal your product, you must
submit a completed Data Call-In Reaeonae Fern, indicating your
election of this option. Voluntary cancellation is item number 5
on th« Data Call-in Besponsa Farm, if you choos» this option, this
is the only form that you ara required to complete.
If you chos* to voluntarily cancal your product, further sale
and distribution of your product aftar tha effective data of
cancellation must ba in accordance with the Existing- Stocks
provisions of this Notice which are contained in Section IV-C.
2* umm PalatIon - you may avoid the requirements of thi*
Notice by eliminating the uses of your product, to which the
requirements apply. If you wish to amend your registration to
delate use*, yea nut submit the Requirements Status and
weapons* Form, a completed application for amendment,
a copy of your proposed amended labeling, and all other information
required for processing the application. Use deletion is option
number 7 on the naauirenant* statu* and Raqlstranf a Response Fop.
You aust also complete a Data Call-in Beaaonee Form by signing tha
certification, item number 8. Application forms for amending
-------
5
registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 517-2126.
If you choose to delete the use(s)•subject to this Notice or
uses subject to specific data requirements, further sale,
distribution, or us* of your product after one year from the due
date of your so day response, must bear an amended label.
3- Generic Data Exemption - Under section 3(c)(2)(D) of
FXFBA, an applicant for registration of a product is exempt froa
the requirement to submit or cite generic data concerning an active
ingredient if the active ingredient in the product is derived
exclusively froa purchased, registered pesticide products
containing the active ingredient. EPA has concluded, as an
exercise of its discretion, that it normally will not suspend the
registration of a product which would qualify and continue to
qualify for the generic data exemption in section 3(c)(2)(D) of
rxntA. To qualify, all of the following requirements must be met;
->3
a. Th« active ingredient in your registered product must be
present «olelv because of incorporation of another
registered product which contains the subject active
ingredient and is purchased from a source not connected
witls you;
b. every registrant who is the ultimata source of the active
ingredient in your product subject to this DC! must be in
compliance with the requirements of this Notice and must
remain in compliance> and
c. You must have provided to EPA. an accurate and current
"Confidential Statement of Formula" for each of your
products to which this Notice applies.
I
To apply for the generic Date exemption you must submit a
completed Data Call-In Response Form, Attachment 1 and all
supporting documentation. The Generic Data Exemption is item
number Ca oa the Pete call-In Response Fora. If you claim a
generic data exemption you are not required to complete the
Beaulg—Mrta atltui tna KMlitrmt't BifMIW rqra» Generic Data
Exemption cannot be selected as an option lor product specific
data*
Zf yon ar* granted a Genaric Data txeaption, yots raly on the
efforts of other* persona to provide the Agency with, the required
data* If'*he registrant(s) who have committed to -generate and
submit the- required data fail to take appropriate steps to meet the
rtquir«MHts or ar* i» longer in. compliance with this Data call-in
Notice, ths Agency will considar that both they and yon ire not in
compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit
to submit and do submit the require* data within the specified
tias. In such cases the Agency generally will not grant a time
extension for subaitting the data.
-------
6
4. Satisfying the Data Requirements of this Notice There are
various options available to satisfy the data requirements of this
Notice. Tftase options are discussed in Section Ill-c of this
notice and comprise option# 1 through 6 on the Requirements status
and Registrant's Hassans* Farm and option 6b and 7 on the Data
Call-in Re.scons« gora. If you choose option fib or 7, you must
submit both forms as well as any other information/data pertaining
to the option chosen to address the data requirement.
5. Reguest far Pata Waivers, oata waivers are discussed in
Section III-D of this Notice and are covered by options 8 and 9 on
the Requirements Status and Registrant's Beanann Form. If you
choose one of these options, you must submit both forms as well as
any other information/data pertaining to the option chosen to
address the data requirement.
III-C SATTSrVTMG THE DATA RSQUIREMEMTS OF THIS NOTICE
If you acknowledge on the Pata Call-in Response Form that you
agree to satisfy the data requirements (i.e. you select option 6b•
and/or 7), then you must select one of the six options on the
Itauirmimti Statue and Registrant's Response Farm related to data
production for each data requirement. Your option selection should
be entered under item number 9, "Registrant Response." The six
options related to data production are the first six options
discussed under item 9 in the instructions for completing the
Reauigeaants Status and Registrant's Response Form. These six
options are listed immediately below- with information in
parentheses to guide registrants to additional instructions
provided in this section. The options are:
(1) I will generate and submit data within the specified
timeframe (Developing Data)
(2) I have entered Into an agreement with one or more
registrants to develop date jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost
Share)
(4) Z mm submitting an existing study that has not been
submitted previously to the Agency by anyone
(Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study
elassifisd by EPA as partially acceptable and
upgradeeble (Upgrading a Study)
(6) Z aa citing an existing study that EPA ham
classified as acceptable or an existing study that
has been submitted but not reviewed by the Agency
(Citing an Existing Study)
-------
option 1. Developing Data — If you choose to develop the
required data it must be in conformance with Agency deadlines and
with other Agency requirements as referenced herein and in .the
attachments. All data generated and submitted must comply with the
Good Laboratory Practice (GLP) rule (40 CFR part ISO), be conducted
according to the Pesticide Assessment Guidelines (PAG), and be in
conformance with the requirements of Pi Notice 16-5. In addition,
certain studies require Agency approval of test protocols in
advance of study initiation. Those studies.for which a protocol
must be submitted have been identified in the Requirements status
and Registrant's Response Form and/or footnotes to the form. If
you wish to use a protocol which differs from the options discussed
in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing to
use it. The Agency may choose to reject a protocol not specified
in Section II-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of
a proposed protocol will not be a basis for extending the deadline
' for submission of data.
A progress report must be submitted for each study within 90
days from the date you are required to commit to generate- or
undertake some other means to address that study requirement, such
as making an offer to cost share or agreeing to share in the cost
of developing that study, k 90-day progress report must be
submitted for all studies. This 90-day progress report must
include the date the study was or will be initiated and, for
studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be
conducting the study.
In addition, if the tins frame for submission of a final
report is nor* than 1 ysar, interim reports must be submitted at 12
month intervals from the data you are required to commit to
generate or otherwise address the requirement tor the study.
In addition to the other information specified in the preceding
paragraph, at e minimum, e brief description of current activity on
and the status ©f the study Bust be included, as veil as a full
description of any problems encountered since the last progress
report.
Th* tia* frames in the Requirements Statue and Registrant's
Bnpome worm are. the time fremes that the Agency is allowing for
the submission of completed study reports or protocols. The noted
deadlines mir fro* the date of the receipt of tbis Notice by the
registrants 12 the data are not submitted toy the deadline, each
registrant, is subject to receipt of a notice of Intent to Suspend
the affected registration(s).
if you cannot submit the data/reports to th« Agency In the
time required by this Notice and intend to seek, additional time to
meet the reqpirements(s), you Bust submit a request to the Agency
which includest (1) m detailed description of the expected
difficulty and (2| a proposed schedule including alternative dates
-------
for meeting such requirements on a step-by-step basis. ¥ou must
explain any technical or laboratory difficulties and provide
documentation from the laboratory performing" the testing. While
EPA is considering your request, the original deadline remains.
The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally,
extensions can be requested only in cases of extraordinary testing
problems beyond the expectation or control of the registrant.
Extensions will not be given in submitting the 90-day responses.
Extensions will not be considered if the request for extension is
not made in a timely fashion? in no event shall an extension
request be considered if it is submitted at or after the lapse of
the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data — if
you choose to enter into an agreement to share in the cost of
producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be
submitting the data. You muet also provide EPh with documentary
evidence that an agreement has been formed. Such evidence may be
your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or e written statement by
the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement
between the parties or the mechanism to resolve the terms. Sect?'^
3(c)(2)(B) provides that if the parties cannot resolve the term?
the agreement they may resolve their differences through binding
arbitration.
Option 3. Offer to Share in the Cost of Data Development — If
you have made an offer to pay in an attempt to enter into an
agreement or amend an existing agreement to meet the requirements
of this Notice and have been unsuccessful, you may request EFA (by
selecting this option) to exercise its discretion not to suspend
your registration(s), although you do not comply with the data
submission requirements of this Notice. EPA has determined that as
a general policy, absent other relevant considerations, it will not
suspend the registration of a product of a registrant who has in
good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s)
developing tha data has refused to accept your offer. To qualify
for this option, you must submit documentation to the Agency
previa? that you have mad* an offer to another registrant (who has
an obligation, to submit data) to share in tha burden of developing
that data* You must also submit to tha Agency a completed EPA Form
8570-32, Certification of Offer to Coat Share in tha Development of
Data, Attachnant X. In addition, you auat daaonitrata that tha
other registrant to idiom tha offer vaa made haa not accepted your
offer to enter into a coataharing agreement by including a copy of
your of far and proof of tha other registrant** racaipt of that
offer (such as a certified mail racaipt). Your offer must, in
addition to anything else, offer to share in tha burden of
producing tha data upon terms to ba agreed or failing agreement to
ba bound by binding arbitration as provided by FIFRA section
-------
3 Cc)(2)(B)(iii) and must not qualify this offer. The other
registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a
pat^ gail-ln p?$pgpse FQCTO and a Requirements Status and
Registrant's Response Form committing to develop and submit the
data required by this Notice,
In order for you to avoid suspension under this option, you
may not withdraw your offer to share in the burdens of developing
the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject to
initiation of suspension proceedings, unless you commit to submit,
and do submit the required data in the specified time frame, in
such cases, the Agency generally will not grant a time extension
for submitting the data.
OBtien 4. Submitting an Existing Study — If you choose to
submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this
Notice. You may only submit a study that has not been previously
submitted to the Agency or previously cited by anyone. Existing
studies are studies which predate issuance of this Notice. Do not
use this option if you are submitting data to upgrade a study. (See
Option 5).
You should be aware that if the Agency determines that the
study is not acceptable, the Agency will require you to comply with
this Hotice, normally without an extension of the required date of
submission. The Agency may determine at any time that a study is
not valid and needs to be repeated.
To meet the requirements of the OCX Notice for submitting an
existing study, all of the fallowing three criteria must be clearly
met a
a. Yens must certify at the time that the existing study is
submitted that, the raw data and specimens from the study are
available for audit and review and you must identify where
the|f arm available. This must be dona in accordance with
the requirements of the Good Laboratory Practice (GLP)
regulation, 40 CTR Part 160. As stated in 40 cm 160.3(ji
• •[r]aw data* means any laboratory worksheets, records,
memoranda*. note*, or exact copies thereof, that are the result
of original observations and activities of a study and are
necessary for the reconstruction and evaluation of the report
of that study. Za the event that exact transcripts of raw
data have been prepared (e.g.r tapes which have been
transcribed verbatim, dated, and verified accurate by
signature) , the exact copy or exact transcript say be
substituted for the original source as raw data. •Raw data*
¦ay include photographs, microfilm or microfiche copies,
-------
10
computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFB 160.3(k), means "any
material derived from a test system for examination or
analysis,11
b. Health and safety studies completed after May 1984 must
also contain all GLP-reguired quality assurance and quality
control information, pursuant to the requirements of 4 0 cfr
Part 160, Registrants must also certify at the tine of
submitting the existing study that such GLP information is
available for post-May 1984 studies by including an
appropriate statement on or attached to the study signed by an
authorized official or representative of the registrant.
e.. You must certify that each study fulfills the acceptance
criteria for the Guideline relevant to the study provided in
the FIFRA Accelerated Reregistration Fhase 3 Technical
Guidance and that the study has been conducted according to
the Pesticide Assessment Guidelines {PAG) or meets the purpose
of the PAG (both available iron NTISJ. A study not conducted
according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is
referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols. Zf you wish to submit the
study, you must. In addition to certifying that the purpose
of the PAG are met by the study, clearly articulate the
rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data.
Zt has b«en the Agency's experience that studies completed
prior to January 1970 rarsly satisfied the purpose of the PAG
and that necessary raw data are usually not available for such
studies.
If you submit an existing study, you must certify that the
study meets all requirements of the criteria outlined above.
If EPA haa previously reviewed a protocol for a study you are
submitting^ yen Bust identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the
maimer in. vhidt ell Agency comments, concerns, or issues were
addressed in th* final protocol and study.
If yourkaoir of a study pertaining to any requirement in this
Notice wtticH does not meet the criteria outlined above but does
contain factual intonation regarding unreasonable adverse effects,
you sust notify the Agency of such a study. Zf such study is in
thm Agency*• files, you need only cits it along with the
notification* It not in the Agency's files, you must submit a
summary and copies as required by PR Notice $6-5.
-------
11
option 5. upgrading a Study — If a study has been classified
as partially acceptable and upgrateable, you-nay submit data to
upgrade that study. The Agency will review the data submitted and
determine if the requirement is satisfied. Iff the Agency decides
the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient,
but upgradeable studies will normally be classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a
study nay be upgraded, call or write the contact person listed in
Attachment A. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by E?A. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected end why the study should be rated as acceptable to EPA.
Your submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.
Co not submit additional data for the purpose of upgrading a -
study classified as unacceptable and determined by the Agency as
not capable of being upgraded.
This option should also be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by tha Agency. You must provide tha MRID number of the
data submission aa wall aa tha MRID number of tha study being
upgraded.
Tha criteria for submitting an existing study, aa specified in
Option 4 above, apply to all data submissions intended to upgrade
studies. Additionally your submission of data intended to upgrade
studies must ba accompanied by a certification that you comply with
each of those criteria aa vail as k certification regarding
protocol compliance with Agency requirements.
Option a. citing Existing studlea — If you choose to cite a
study that lias bean previously submitted to SPA, that, study must
have been previously classified by SPA as acceptable or it must be
a study which ha* not yet been reviewed by the Agency. Acceptable
toxicology studies, generally trill have bee* classified as "core-
guideline^ or- "core minimum." For ecological effects- studies, the
classification generally would be s rating'o£ "core.* for all
other disciplines tha classification would be "acceptable." with
respect to any* studies for which you wis* ta select this option you
must provide the KR2D number of th* study you are citing and, if
the study bis- been reviewed by the Agency, you must provide the
Agancy's classification of tha study.
If you are citing a study of which you are not tha original
data submitter, yoa aust submit a completed copy of SPA For*
8570-31, e«rfclfleetlow with Respect to Data Compensation
aeoulrements.
-------
12
III-D REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice.
The first is a request for a low volume/minor use waiver an; the
second is a waiver request based on your belief that the data
requirement(s) are inapplicable and do not apply to your product.
1- Low Volume/Minor Use Waiver — Option 8 on the Requirements
Status and Registrant's Response Form. Section 3(C)(2)(A) of FIFRA
requires EPA to consider the appropriateness of requiring data for
low volume, minor use pesticides. In implementing this provision
EPA considers as low volume pesticides only those active
ingredients whose total production volume for all pesticide
registrants is small. In determining whether to grant a low
volume, minor use waiver the Agency will consider the extent,
pattern and volume of use, the economic incentive to conduct the
testing, the importance of the pesticide, and the exposure and risk
from use of the pesticide. If an active ingredient, is used for
both high volume and low volume uses, a low volume exemption will
not be approved. If all uses of an active ingredient are low
volume and the combined volumes for all uses are also low, then an
exemption may be granted, depending on review of other information
. outlined below. Ail exemption will not be granted if any registrant
of the active ingredient elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain
within the sales figures in their forecast supporting the waives
request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the
waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for 8 low volume, minor use waiver, you must sub-nit
the following information, as applicable to your product
-------
13
b. Total direct production cost of product(s) containing
the active ingredient by year for the past five years.
Include information on raw material cost, direct
labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
c. Total indirect production cost (e.g. plant overhead,
aaorti2ed plant and equipment) charged to product(s)
containing the active ingredient by year for the past
five years-. Exclude all non-recurring coats that were
directly related to the active ingredient, such as
cost* of initial registration and any data development.
d(i). A list of each data requirement for which you seek
a waiver. Indicate the type of waiver sought and
the estimated cost to you (listed separately for
each data requirement and associated test) of
conducting the testing needed to fulfill each of
these data requirements.
ii. A list of each data requirement for which you are not
seeking any waiver and the estimated cost to you
(listed separately for each data requirement and
associated test) of conducting the testing needed to
fulfill each of these data requirements.
e. For eaclt of the next ten years, a year-by-year fore-
cast of company sales (pounds and dollars) of the
active ingredient, direct production costs of product(s)
containing the active ingredient (following the
parameters in item 2 above), indirect production
costs of product(s) containing the active ingredient
(following the parameters in item 3 above), and
costs of data development pertaining to the active
ingredient*.
f . A description of the importance and unique benefits of
the ective ingredient to users. Discuss the us*
pattern* end the effectiveness of the- ective ingredient
relative to registered alternative chemicele end.
non-chemical control strategies. focus on benefits
uniqu* ta the ective ingredient, providing information
that, is es quantitative as possible. If you da not
have-quantitative data upon which to base your estimates,
then present the reasoning used to derive your estimates.
To assist the Agency in determining the degree of
importance of the active ingredient in terms of its
benefits, you should provide information on any of
the. following factors, as applicable to your product(s)i
(a) dociaontation of the usefulness of the active
ingredient in Integrated Pest Management, (b) description
of the - beneficial impacts on the environment of use
of the active ingredient, a» opposed t» it* registered
-------
14
alternatives, (c) information on the breakdown of the
active ingredient after use and on its persistence in
the environment, and (d) description of its usefulness
against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to
sake a determination regarding a request for a low volume/minor use
waiver will result in denial of the request for a waiver.
2. Request for Waiver af Date — Option § on the Requirements
Status and Registrant's Response Form, This option may be used if
you believe that a particular data requirement should not apply
because the corresponding use is no longer registered or the
requirement Is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply.
You must also submit the current label(s) of your product(s) and,
if a current copy of your Confidential Statement of Formula is not
already on file you sust submit a current copy.
You will be informed of the Agency's decision in writing. If
the Agency determines that the data requirements of this Notice do
not apply to your product(a), you will not be required to supply
the data pursuant to section 3(c)(2)(B). If EPA determines that
, the data ire required for your productfsK vou must choose a method
of meeting the requirements of this Notice within the tine ftant
provided bv this Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised Requirement:
status and Registrant's Response Form indicating the option chose.
IV. . CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE" ~
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with ths requirements of this Data Call-in Notice, pursuant to
FIFRA taction 3(e)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the- following:
1. Failure to respond as required by this Notice within 90
day* of your receipt of this Notice* .
2. Failure to submit on the required schedule an acceptable
proposed or final protocol when such is required to be
submitted, to the Agency for review.
3. Failure to submit on the required schedule an adequate
progress report on e study as required by this Notice.
4. Failure to subait on the required schedule acceptable
date mm required by this Notice.
-------
15
5. Failure to take a required action or submit adequate
information pertaining to any option chosen to address the
data requirements (e.g., any required action or information
pertaining to submission or citation of existing studies or
offers, arrangements, or arbitration on the sharing of costs
or the formation of TasJc Forces, failure to comply with the
terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data
waiver),
6. Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section iii-c
of this Notice.
7. withdrawal of an offer to share in the cost of developing
required data.
8. Failure of the registrant to whoa you have tendered an
offer to share in the cost of developing data and provided
proof of the registrant's receipt of such offer or failure of
a registrant on whom you rely for a generic data exemption
either to: m
a. inform EFA of intent to develop and submit the data
required by this Notice on a Data Call-in Response Form and
a Requirements Status and Registrant's Response Form?
b. fulfill the commitment to develop and submit the data as
required by this Notice} or
c. otherwise taks appropriate steps to meet the
requirements stated in tills Notice,
unless you commit to submit and do submit ths required
the specified time frame.
9. Failure to talis any required or appropriate steps,
mentioned, above, at any time following the issusncs of
Notice.
IV-B^ BAST* wem PfTHamiATTOW THAT SUBMITTED STUDY TS
OmCCTPTAlI*
Til* Agency may determine that s study (even if submitted
within ths required time} is unacceptable and constitutes e basis
for issuance of a Notice of Xntsnt to suspend* The grounds for
suspension include, but are not limited, to, failure to meet any of
the following:
data in
not
this
-------
16
X. EPA requirements specified in the Data call-In Notice or
other documents incorporated by reference (including, as
applicable, CPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of
required studies. Such requirements include, but are not
limited to, those relating to test material, test procedures,
selection of species, number of animals, sex and distribution
of animals, dose and effect levels to be tested or attained,
duration of test, and, as applicable. Good Laboratory
Practices.
2. CPA requirements regarding the submission of protocols,
including the incorporation of any changes required by the
Agency following review.
3. EPA requirements regarding the reporting of data,
including the manner Qf reporting, the completeness of
results, and the adequacy of any required supporting (or raw)
data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR 86-5. All
studies must be submitted in the form of a final report,' a
preliminary report will not be considered to fulfill the
submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OH CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale,
distribution and use of existing stocks of e pesticide product
which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants
of existing stocks for a suspended registration when a section
3(c)(2)
-------
17
circumstances, one yaar from tha date your 90 day response to this
Notice is due, to sail, distribute, or use existing stocks.
Normally, tha Agency will allow parsons othar than tha registrant
such as independent distributors, ratailars and and usars to sail,
distribute or use such existing stocks until tha stocks are
exhausted. Any sala, distribution or usa of stocks of voluntarily
cancelled products containing an activa ingredient for which tha
Agency has particular risk concama will ba determined on case-by-
casa basis.
Requests for voluntary cancellation received after the 90 day
response period required by this Notice will not result in the
Agency granting any additional tine to sell, distribute, or usa
existing stocks beyond a year from tha data tha 90 day response was
due unless you demonstrate to the Agancy that you are in full
compliance with all Agancy requirements, including tha requirements
of this Notice. For example, • if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and goodi faith manner must have been submitted to the
Agency, before EPA will consider granting an existing stocks
provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(3) states
that if at any time after a pesticide is registered a registrant
has additional factual information ragarding unreasonable adverse
effects on the environment by tha peeticide, tha ragistrant shall
submit tha information to tha Agancy. Registrants must notify the
Agancy of any factual information they have, from whatever aource,
including but net limited to interia or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues ae long as the products
are registered by the Agency.'
SICTXOK vr. nam*** Aim responses to this notice
If yotK have- any questions regarding the requirements and
procedure*established by this Notice, call the contact person
listed, in Attachment Af the Pat* Call-in Cheialeal Statue Sheet.
All response* to this Notice (other than voluntary
cancellation requests and generic data exemption claias) must
includa a completed Beta cell-Tn Response Warm (Attachment B) and a
completed —alga—nto Status and Registrant'a Response Form
(Attachment C) ud any othar docuaanti raquirad by this notice, and
should be submitted to the contact person Identified in Attachment
A. Sf tha voluntary cancellation or generic data exemption option
is chosen# only tha Data caii-m Response form need ba submitted.
-------
18
The office of Compliance Monitoring (OCM) of the Office of
Pesticides and Toxic Substances (OPTS), EPA* wij.1 be monitoring the
data being generated in response to this Notice.
Sincerely,
Daniel M. Barolo, Director
Special Review and
Raregistration Division
Attachments
A - Data Call-in Chemical Status Sheet
B - Data Call-In Response For*
C " Reouirements Status and Registrants
Rfggon»t Fora
D - List of Registrants Receiving This Wotlea
E - Cost Share and Data Comaeneatlon Forms
-------
ATTACHMENT A
CHEMICAL STATUS SHEET
-------
ZINC SALTS: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing zinc chloride or zinc sulfate.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of zinc salts.
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 DCI (Attachment D),
(5) the EPA Acceptance Criteria (Attachment E), and (6) the Cost Share and Data Compensation
Forms in replying to this Zinc Salts Generic Data Call-In (Attachment F). Instructions and
guidance accompany each form.
DATA REQUIRED BY THIS NOTICE .
The additional data requirements needed to complete the generic database for zinc salts
are contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional product chemistry data on zinc chloride, zinc sulfate and zinc oxide
are needed. These data are needed to fully complete the reregistration of all eligible zinc salts
products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Mark Wilhite at (703) 308-8586.
All responses to this Notice for the generic data requirements should be submitted to:
Mark Wilhite, 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: ZINC SALTS
-------
ATTACHMENT B
GENERIC DATA CALL-IN RESPONSE FORMS (Form A)
PLUS INSTRUCTIONS
-------
SPECIFIC INSTRUCTIONS FOR
THE DATA CALL-IN RESPONSE FORM
This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering _ asticides under the Federal Insecticide Fungicide
and Rodenticide Act. Fill out this form each time you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response."
Items 1 -4 will have been preprinted on the form. Items 5
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-22 3, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.c. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and
address.
Item 2. This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations
relevant to the data call-in. Please note that you are
also responsible for informing the Agency of your
response regarding any product that you believe may be
covered by this data call-in but that is not listed by
the Agency in Item 4. You must bring any such apparent
omission to the Agency's attention within the period
required for submission of this response form.
Item 5. Check this item for each product registration you wish
to cancel voluntarily. If a registration number is
listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on
-------
2
the Requirements Status and Registrant's Response Form
for any product that is voluntarily cancelled.
Item 6a. Check this item if this data call-in is for generic
data as indicated in Item 3 and if you are eligible for
a Generic Data Exemption for the chemical listed in
Item 2 and used in the subject product. By electing
this exemption, you agree to the terms and conditions
of a Generic Data Exemption as explained in the Data
Call-in Notice,
If you are eligible for or claim a Generic Data
Exemption, enter the EPA registration Number of each
registered source of that active ingredient that you
use in your product.
Typically, if you purchase an EPA-registered product
from one or more other producers (who, with respect to
the incorporated product, are in compliance with this
and any other outstanding Data Call-in Notice), and
incorporate that product into all your products, you
may complete this item for all products listed on this
form. If, however, you produce the active ingredient
yourself, or use any unregistered product (regardless
of the fact that some of your sources are registered),
you may not claim a Generic Data Exemption and you may
not select this item.
Check this Item if the data call-in is a generic data
call-in as indicated in Item 3 and if you are agreeing
to satisfy the generic data requirements of this data
call-in. Attach the Requirements Status and
Registrant's Response Form that indicates how you will
satisfy those requirements.
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.
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 Registrant's Response Form that
indicates how you will satisfy those requirements.
This certification statement must be signed by an
authorized representative of your company and the
Item 6b.
.Item 7a.
Item 7b,
Item 8.
-------
3
person signing must include his/her title. Additional
pages used in your response must be initialled and
dated in the space provided for the certification.
Item 9- Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. Enter the phone number of your company contact.
-------
United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE
Pag
of 1
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink.
Use additional sheet(s) if necessary
Please rend carefully the attached instructions and supply the information requested on this form.
1, Company name and Address 058509
DAVID A. WALTZ IMPORTS
D/B/A MENZIES SHEET METAL
13903 S.E. X4TH ST
—VENCorrvFR ha,
2. Case # and Name
4099 Zinc salts
Chemical # and Name 088502
Zinc oxide
3. Date and Type of DCI
GENERIC
4. EPA Product
Registration
5, I wish to
cancel this
product regis-
tration volun-
tary ly
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration nutiber listed below.
6b. ! agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7, Product Specific Data
7a. My product is an HUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. Hy product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
58509-1
8. Certification
] certify that the statements made on this form and all attachments are true, accurate, and complete.
] acknowledge that any knowingly false or misleading statement may be punishable by fine, inprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9, Date
10. None of Company Contact
11. Phone Hunter
-------
Fag*. x of 1
United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions arid supply the information requested on this form.
Use additional sheet
-------
Pag. . of 1
United States Environmental Protection Agency
Washington, D.C. 20460
DfcTA CALL-IN RESPONSE
form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary
1. Company name and Address 050019
JAMES W. NIELSEN
BOX 6669
BROOKINGS OR, 97415
(
2. Case # and Name
4099 Zinc salts
Chemical # and Name 088502
Zinc oxide
3. Date and Type of DCI
GENERIC
4. EPA Product
Registration
5. 1 wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
7, Product Specific Data
6a. 1 am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
fib. I agree to satisfy generic
Data requirements as indicated
an the attached form entitled
"Requirements Status and
Registrant's Response."
7m. By product is an MUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an IUP and
I agree to satisfy the EUP
requirements m the attached
form entitled "Requirements
Status and Registrant's
Response."
50019-1
8. Certification
I certify that the statements made ©r» this form and alt attachments arm true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
. 9. Date
10. Name of Company Contact
11. Phone Number
-------
Pac, of 1
United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS; Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet
-------
Pag. .l of 1
United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE
Form Approved
0MB Ho. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary
1. Company name and Address 000802
CHAS H. LILLY CO.
7737 N.E. KILLINGSWORTH
PORTLAND OR, 97218
2. Case # and Name
4099 Zinc salts
Chemical # and Name 087801
Zinc chloride
3. Date and Type of DCI
GENERIC
4. EPA Product
Registration
5. I wish to
cancel this
product regis-
trat ion volun-
tar i ly
6. Generic Data
7. Product Specific Data
6a. t ant claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration nunber listed below.
6b. t agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is an HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. Hy product is an EUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
802-508
802-553
8. Certification
I certify that the statements made on this form and alt attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10. Name of Company Contact
51. Phone Number
-------
Faqv of 1
United States Environmental Protection Agency
Washington, D.c. 20460
DATA CALL-IN RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary
1. Company name and Address 000802
CHAS H. LILLY CO.
773 7 N.E. KILLINGS WORTH
PORTLAND OR, 97218
2. Case # and Maine
4099 Zinc salts
Chemical # and Name 527200
Zinc Sulfate Konchydrate
3. Date and Type of DC 1
GENERIC
4. EPA Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
7. Product Specific Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. 1 agree to satisfy Seneric
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is an HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b, My product is an EUP snd
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
802-591
8. Certification
1 certify that the statements made on this form and att attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10. Name of Company Contact
11. Phone Number
-------
ATTACHMENT C
GENERIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
FORMS (Form B) PLUS INSTRUCTIONS
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for
both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1)
deletion of uses or (2) request for a low volume/minor use
waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of items. DO NOT use this form for any other
active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on
the form. You must complete all other- items on this form by
typing or printing legibly.
Public reporting burden for this collection of information
is estimated to average 3 0 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223 , U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and. Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
2
INSTRUCTIONS
Item l. This item identifies your company name, number, and
address.
Item 2, This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of
studies required to support the product(s) being
reregistered. These guidelines, in addition to
requirements specified in the Data Call-in Notice,
govern the conduct of the required studies.
Item 5. This item identifies the study title associated with
the guideline reference number and whether protocols
and 1, 2, or 3-year progress, reports are required to be
submitted in connection with the study. As noted in
Section III of the Data Call-in Notice, 90-day progress
reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached
information relevant to this guideline reference number
to the Requirements Status and Registrant's Response
Form.
Item 6. This item identifies the code associated with the use
pattern of the pesticide. A brief description of each
code follows:
A
Terrestrial food
B
Terrestrial feed
C
Terrestrial non-food
D
Aquatic food
E
Aquatic non-food outdoor
F
Aquatic non-food industrial
G
Aquatic non-food residential
H
Greenhouse food
I
Greenhouse non-food crop
J
Forestry
K
Residential
L
Indoor food
M
Indoor non-food
N
Indoor medical
0
Indoor residential
-------
3
Item 7. This item identifies the code assigned to the substance
that must be used for testing. A brief description of
each code follows:
EP
End-Use Product
MP
Manufacturing-Use Product
MP/TGAI
Manufacturing-Use Product and Technical
Grade Active Ingredient
PAI
Pure Active Ingredient
PAI/M
Pure Active Ingredient and Metabolites
PAI/PAIRA
Pure Active Ingredient or Pure Active
Ingredient Radiolabelled
PAIRA
Pure Active Ingredient Radiolabelled
PAIRA/M
Pure Active Ingredient Radiolabelled and
Metabolites
PAIRA/PM
Pure Active Ingredient Radiolabelled and
Plant Metabolites
TEP
Typical End-Use Product
TEP %
Typical End-Use Product, Percent Active
Ingredient Specified
TEP/MET
Typical End-Use Product and Metabolites
TEP/PAI/M
Typical End-Use Product or Pure Active
Ingredient and Metabolites
TGAI
Technical Grade Active Ingredient
TGAI/PAI
Technical Grade Active Ingredient or
Pure Active Ingredient
TGAI/PAIRA
Technical Grade Active Ingredient or
Pure Active Ingredient Radiolabelled
TGAI/TEP
Technical Grade Active Ingredient or
Typical End-Use Product
MET
Metabolites
IMP
Impurities
DEGR
Degradates
*
See: guideline comment
Item 8. This item identifies the time frame allowed for
submission of the study or protocol identified in
item 2. The time frame runs from the date of your
receipt of the Data Call—In Notice.
Item 9. Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement.
Brief descriptions of each code follow. The Data Call-
in Notice contains a fuller description of each of
these options.
1. (Developing Data) I will conduct a new study and
submit it within the time frames specified in item
8 above. By indicating that I have chosen this
option, I certify that I will comply with all the
-------
4
requirements pertaining to the conditions for
submittal of this study as outlined in the Data
Call-in Notice and that I will provide the
protocols and progress reports required in item 5
above.
2. (Agreement to Cost Share) I have entered into an
agreement with one or more registrants to develop
data jointly. By indicating that I have chosen
this option, I certify that I will comply with all
the requirements pertaining to sharing in the cost
of developing data as outlined in the Data Call-In
Notice.
3. (Offer to Cost Share) I have made an offer to
enter into an agreement with one or more
registrants to develop data jointly. I am
submitting a copy of the form "Certification of
Offer to Cost Share in the Development of Data"
that describes this offer/agreement. By
indicating that I have chosen this option, I
certify that I will comply with all the
requirements pertaining to making an offer to
share in the cost of developing data as outlined
in the Data Call-in Notice,
4. (Submitting Existing Data) I am submitting an
existing study that has never before been
submitted to EPA, By indicating that I have
chosen this option, I certify that this study
meets all the requirements pertaining to the
conditions for submittal of existing data outlined
in the Data Call-in Notice and I have attached the
needed supporting information along with this
response,
5. (Upgrading a Study) I am submitting or citing data
to upgrade- a study that EPA has classified as
partially acceptable and potentially upgradeable.
By indicating that I have chosen this option, I
certify that I have met all the requirements
pertaining to the conditions for submitting or
citing existing data to upgrade a study described
in the Data Call-in Notice. I am indicating on
attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned
to the data that I am citing as well as the MRID
of the study I am attempting to upgrade.
6. (citing a Study) I am citing an existing study
that has been previously classified by EPA as
acceptable, core, core minimum, or a study that
-------
5
has not yet been reviewed by the Agency. I am
providing the Agency's classification of the
study.
7. (Deleting Uses) I am attaching an application for
amendment to my registration deleting the uses for
which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read
the statements concerning low volume-minor use
data waivers in the Data Call-in Notice and I
request a low-volume minor use waiver of the data
requirement. I am attaching a detailed
justification to support this waiver request
including, among other things, all information
required to support the request. I understand
that, unless modified by the Agency in writing,
the data requirement as stated in the Notice
governs.
9. (Request for Waiver of Data) 1 have read the
statements concerning data waivers other than low-
volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data
requirement. I am attaching an identification of
the basis for this waiver and a detailed
justification to support this waiver request. The
justification includes, among other things, all
information required to support the request. I
understand that, unless modified by the Agency in
writing, the data requirement as stated in the
Notice governs.
Item 10. This item must be signed by an authorized
representative of your company. The person signing
must include his/her title, and must initial and date
all other pages of this form.
Item 11. Enter the date of signature.
Item 12, Enter the name of the person EPA should contact with
questions regarding your response.
Item 13, Enter the phone number of your company contact.
-------
pfc
1 of 1
United States Environmental Protection Agency-
Washington, D.C. 2 04 60
REQUIREMENTS STATUS MID REGISTRANT'8 RESPONSE
Form Approved
OHB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the Information requested on this form.
Use additional sheet(s)
i f necessary
1. Company name and Address 003098
2.
Case # and Name
3. Date and Type of DC1
BAXTER J H
COMPANY
4099 Zinc salts
GENERIC
1700 S EL CAMXNQ REAL
Chemical #
and Name 088502
SAN MATEO CA 94402
1
Zinc
oxide
4. Guideline
Requi rement
Number
5. Study Title
j
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
1
2
3
61-1
Chemical Identity
all
TGAI
12
mos,
61-2(a)
Begin, mat. & ntrfg. proc
all
TGAI
12
mos.
61-2(b)
Discussion of Impurities
all
TGAI
12
mos.
62-1
Preliminary Analysis
all
Ttai
12
ittOS *
62-2
Certification of limits
all
TGAI
12
mos.
62-3
Analytical Method
all
TGAI
12
mos.
63-2
Color
all
TGAI
12
mos.
63-3
Physical State
all
TGAI
12
mos.
63-4
Odor
all
TGAI
12
mos.
63-5
Halting Point
all
TGAI
12
moi»
63-6
Boiling Point
all
TGAI
12
mos.
63-7
Density
all
TGAI
:12
mos.
63-8
Solubi lity
all
TGAI
12
iito s.
63-9
Vapor Pressure
all
T«I
12
•: iti&Su
63-13
Stability
all
TGAI
12
mos.
10. Certification
11. Date
I certify that the statements made on this form and nil attachmentb are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
signature and Title of Company's Authorized Representative
12. Name of Company Contact
13. Phone Number
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission Pg'
"onpany Munber / Name BAXTER J H & COMPANY
03098 / Address SAN MATEO, CA
Chemical Number / Hame
088502 Zinc oxide
Case Muraber / EPA Manager Use Pattern
4099 Mark Wilhite C
REGISTRANT'S
GDLN # DESCRIPTION COMPLIANCE/MRID EPA DECISION
61-1 Chemical Identity
Comments: This guideline appears as a data gap for another
registrant, it does not apply to you.
61-1 Chemical Identity 42126501
61-2(a) Begin, mat. & mnfg. proc
Comments: See comments for guideline 61-1.
Pending
1-2(aj Begin, mat, & mnfg. proc 42126501
61-2(b) Discussion of Impurities
Comments: See comments for guideline 61-1,
•Pending
61-2(b) Discussion of Impurities 42126501 Pending
62-1- .-preliminary Analysis---
Comments: You must provide analysis of five production samples
showing upper, lower and nominal concentrations, in
accordance with PR-Notice 91-2, and the upper limits
of all impurities. A confidential statement of
formula must also be submitted.
62-1 ®relimi:iil^i:y ¦¦ ¦ 42126502 Pending
62-2- ¦¦ ¦ T*Ctrtiffcatioifrii:"limits-. . Data Gap
62-2 '¦ .Certif icat:i:dn"v'of:;;i,iails:^::-;:-"--------:-;":42126502---:- Pending
62-3 Analytical Method Data Gap
Comments: The anlytical method required must be validated and
sample chromatograms must be submitted.
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission Pg* 2
r —
^emical/Case Number
Company Number / Name
38502 / 4099
003 098 BAXTER
J H & COMPANY
REGISTRANT'S
GDLN # DESCRIPTION
COMPLIANCE/MRID
EPA DECISION
62-3 Analytical Method 4212 6502 Pending
63-2 Color
Comments: See comments for guideline 61-1.
63-2 Color 42126503 Pending
63-3 Physical State
Comments: See comments for guideline 61-1.
63-3 Physical State 42126503 Pending
-4 odor
Comments: See comments for guideline 61-1.
63-4 Odor 42126503 Pending
63-5 Melting Points,::.-:,\'¦¦¦
Comments: See comments for guideline 61-1.
63-6 Boiling Point
Comments: See comments for guideline 61-1.
63-6
63:^7
Boiiing Point
Density .-j:.
42126503
Pending
Data Gap
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission
Pg. 3
^emical/Case Number
;88502 / 4099
Company Number / Name
003 098 BAXTER J H & COMPANY
GDLN # DESCRIPTION
REGISTRANT'S
COMPLIANCE/MRID
EPA DECISION
Comments: You did not identify the unit expressed for bulk
density in your submission.
63-7 Density
63-8 Solubility
Comments:
42126503
See comments for guideline 61-1.
Pending
63-8 Solubility 42126503
63-9 Vapor Pressure
Comments: See comments for guideline 61-1,
Pending
63-13 Stability
Comments: See comments for guideline 61-1.
160-5 Chemical identity 41777901 Pending
171-2 Chemical identity 41777901 Pending
-------
Pav 1 of 1
United States Environmental Protection Agency-
Form Approved
Washington,
D.
2. 20460
OHB No. 2070-0107
REQUIREMENTS STATUS
AND REGISTRANT'S RESPONSE
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print Irs ink. Please read carefully the attached instructions arid supply the information requested on this form.
Use additional sheet(s)
if necessary
1. Company name and Address 050019
2.
Case # and name
3. Date and Type of DC!
JAMES W. NIELSEN
4099 Zinc salts
GENERIC
BOX 6669
Chemical #
and Name 088502
BROOKINGS OR 97415
Zinc
oxide
4. Guideline
5. Study Title
1
Progress
6. Use
7. Test
8.
Time
9, Registrant
Requi rement
I
Reports
Pattern
Substance
Frame
Response
Number
X
P
1
2
3
61-1
Chemical Identity
all
TGAI
12
IROS •
61-2(a)
Begin, mat. & mnfg. proc
all
T6AI
12
mos.
61-2(to)
Discussion of Impurities
all
TGAI
12
HIOS *
62-1
Preliminary Analysis
all
TGAI
12
mos.
62-2
Certification of limits
all
TGAI
12
BIOS.
62-3
Analytical Method
all
TGAI
12
¦ mos.
63-2
Color
all
1GA!
12
rtos
63-3
Physical State
ill ¦
TGAI
12
mos.
63-4
Odor
all
TGAI
12
mos
63-5
Melting Point
all
ffflll •:
12
: mos
63—6
ioiling Point
all
TGAI
12
mos.
63-7
Density
all
TGAI •'
12
mos» • ¦ •
63-8
Solubility
all
TGAI
12
mos.
63-9
Vapor Pressure
all
TGAI
ii-
mos.
63-13
Stability
all
TGAI
12
mos.
10. Certification
11.
Date
I certify that the statements made on this form and alt attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature arid Title of Company's Authorized Representative
12, Name of Company Contact
13.
'hone Number
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission
ompany Number / Name JAMES W. NIELSEN
J50019 /Address BROOKINGS, OR
Chemical Number / Name
088502 Zinc oxide
Case Number
4099
/ EPA Manager
Mark Wilhite
Use Pattern
K
GDLN #
DESCRIPTION
REGISTRANT'S
COMPLIANCE/MRID
EPA
DECISION
61-1
Chemical Identity
Data
Gap
61-2(a)
Begin, mat. .& mnfg. proc
Data
Gap
61-2(b)
Discussion of Impurities
Data
Gap
62-1
Preliminary Analysis
Data
Gap
62-2
Certification of limits
Data
Gap
62-3
Analytical Method
Data
Gap
3-2
Color
Comments: See comments for
guideline 61-1. ,
63-3
Physical State
Data
Gap
63-4
Odor
Data
Gap
63-5
Melting Point
Data
Gap
63-6
Boiling Point
Data
Gap
63-7
Density
Data
Gap
63-8
Solubility
Data
Gap
63-9
Vapor Pressure
Data
Gap
63-13
Stability
Data
Gap
-------
Fat)c 1 of 1
United States Environmental Protection Agency
Form Approved
Washington,
D.
C, 20460
0MB NO. 2070-0107'
REQUIREMENTS STATUS
AND REGISTRANT'8 RISPOHSS
Approval Expires 12*31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s)
if necessary
1. Ccmpany name and Address 055500
2.
Case # and Name
3. Date and Type of DCI
WESPAC ENTERPRISES INC
4099 Zinc salts
GENERIC
2415 S 200TH ST BOX 46337
Chemical #
and Name 088502
SEATTLE WA 9814 6
Zinc
oxide
4. Guideline
Requirement
Number
5. Study Title
a
Progress
leports
6, Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
5
1
2
3
61-1
Chemical Identity
all
TGAI
12
mos.
61-2(a)
Begin, mat. & mnfg. proc
all
TfiAt
12
mac
ulyS •
61-2(b)
Discussion of Impurities
all
TGAI
12
mos.
62-1
Preliminary Analysis
all
T6AI '
'12'
-&&&. .*
62-2
Certification of limits
all
TGAI
12
mos.
62-3
Analytical Method
all
TGAl
12
mos.
63-2
Color
all
TCAI
12
mos.
63-3
Physical State
all
TGAI
12
mos.
63-4
Odor
all
TGAl
12
mos.
63-5
Melting Point
all
tm ¦
12
63-6
BoiLing Point
all
THAI
12
mos.
63-7
Densi ty
all'
TGAI
12"
63-8
Solubi I ity
all
TSAI
12
mos.
63-9
Vapor Pressure
all
TGAl '''
m
-r
63-13
Stabi I i ty
all
TGAI
12
mos.
10. Certification
11.
Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
! acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable Ian.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
13.
Phone Number
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission
-ompany Number / Name WESPAC ENTERPRISES
555 00 / Address SEATTLE, WA
INC.
ChemicaL Number / Name
088502 Zinc oxide
Case Number
4099
/ EPA Manager Use Pattern
Mark wilhite K
GDLN #
DESCRIPTION
REGISTRANT'S
COMPLIANCE/MRID
EPA
DECISION
61-1
Chemical Identity
Data
Gap
61-2(a)
Begin, mat, & mnfg. proc
Data
Gap
61-2(b)
Discussion of Impurities
Data
Gap
62—,1
Preliminary Analysis
Data
Gap
62-2
Certification of limits
Data
Gap
62-3
Analytical Method
Data
Gap
"3-2
Color
Data
Gap
^3-3
Physical State
Data
Gap
63-4
Odor
Data
Gap
63-5
Melting Point
Data
Gap
63-6
Boiling Point
Data
Gap
63-7
Density
Data
Gap
63-8
Solubility
Data
Gap
63-9
Vapor Pressure
Data
Gap
63-13
stability
Data
Gap
-------
Pa 1 of 1
United States Environmental Protection Agency-
Form Approved
Washington,
D.
C. 20460
OMB No. 2070-0107
REQUIREMENTS STATUS
AND REGISTRANT'S RESPONSE
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
on this form.
Use additional sheet(s)
if necessary
1. Company name and Address 058509
2.
Case
fit and Name
3. Date and Type of DC!
DAVID A, WALTZ IMPORTS
4099 Zinc salts
GENERIC
B/B/A M1NZIES SHEET METAL
Chemical # and Name 088502
13903 S.E. 14TH ST
Zinc
oxide
VANCOtlVFP WA 9R6R4
4, Guideline
Requirement
Number
5. Study Title
j
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
|
1
2
3
61-1
Chemical identity
all
TCAI
12
mos.
61-2(a)
Begin, mat. & nrtfg. proc
all
mi
12
mosi.
61-2(b^
Discussion of Impurities
all
TGAl
12
mos.
62-1
Preliminary Analysis
all'-'
tgai
12
mds.i:
62-2
Certification of limits
all
TGAl
12
mos.
62-3
Analytical Method
all
TGAl
12
63-2
Color
all
TGAl
12
mos.
63-3
Physical State
all
TGAl
12J
i' mos.
63-4
Odor
all
TGAl
12
mos.
63-5
Melting Point
all
T6A1
12
•• 'iadi.
63-6
Boi I ing Point
all
TGAl
12
mos.
63-7
Dens ity
all
TCAI
12
mos
63-8
Solubility
all
TGAl
12
mos.
63-9
Vapor Pressure
all
TCAI
12
ttos.";«! -
63-13
Stability
all
TGAl
12
mos.
10, Certification
11. Date
1 certify that the statements made on this form and all attachment* are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
13. Phone Nunber
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission p:
Company Nunber / Name DAVID A. WALTZ IMPORTS
58 509 / Address VANCOUVER, WA
Chemical Number / Name
088502 Zinc oxide
Case Number / EPA Manager Use Pattern
4099 Mark Wilhite K
REGISTRANT'S
GDLN # DESCRIPTION COMPLIANCE/MRID EPA DECISION
61-1 Chemical Identity
Comments; This guideline appears as a data gap for another
registrant. It does not apply to you,
61-1 Chemical Identity 41672401 Pending
61-2(a) Begin, mat. & mnfg. proc
Comments: See comments for guideline 61-1.
61-2(a) Begin, mat. & mnfg, proc 41672401 Pending
61-2(b) Discussion of Impurities
Comments5 See comments for guideline 61-1.
61-2(b) Discussxbn of Impurities 41672401 Pending
62-1 Preliminary Analysis Data Gap
62-2 Certification of. limits ¦ Data Gap.
62-2 Certi f i catio n of limits 41672401 Pending
62-3 Analytical Method Data Gap
62-3 ¦ .Anaiytical:--::-'Method: .. -.41672401 Pending,
63-2 'CoIbiM-
Comments: See comments for guideline 61-1.
o3-2
Color
41672401
Pending
-------
U.S. environmental Protection Agency
Response to Phase 3 Submission Pg* 2
I
•"hemioil/Cuss Number
Company Number / Name
88502 / 4099
058509 DAVID A.
WALTZ IMPORTS
REGISTRANT'S
GDLN # DESCRIPTION
COMPLIANCE/MRID
EPA DECISION
63-3 Physical State
Comments; See comments for guideline 61-1.
63-3 Physical State 41672401 Pending
63-4 Odor
Comments: See comments for guideline 61-1.
63-4 Odor 41672401 Pending
63-5 Melting Point
Comments; See comments for guideline 61-1.
63-5 Melting Point ^ 41672401 Pending
63-6 Boiling Point
Comments; See comments for guideline 61-1,
63-6 Boiling Point 41672401 Pending
63-7 Density 41672401 Pending
63-8
Comments: See comments for guideline 61-1.
63-8
63-9
Solubility
'¦Wtpor. Pressure
41672401
-Fending
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission
'"hemicat/Case Number
Company Number / Name
88502 / 4099
058509 DAVID A.
WALTZ IMPORTS
REGISTRANT'S
GDLN # DESCRIPTION
COMPLIANCE/MRID
EPA DECISION
Comments: See comments for guideline 61-1.
63-9 Vapor Pressure 41672401 Pending
63-10 Dissociation constant- 41672401 Pending
63-13 Stability
Comments: See comments for guideline 61-1.
63-13
Stability
4167-2401
Pending
-------
Pa 1 of l
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
OMB No, 2070-0107
approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the Information requested on this form.
Use additional sheet(s) if necessary
1. Company name and Address 000802
CHAS H. LILLY CO.
7737 N.E. KILLINGSWORTH
PORTLAND OR 97218
2. Case # and Name
4099 Zinc salts
Chemical # and Name 087801
Zinc chloride
3, Date and Type of DCI
GENERIC
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission
"ompany Nunber
/ Name
CHAS H. LILLY CO.
00802
/ Address
PORTLAND,
OR
Chemical Number
/ Name
087801
Zinc
chloride
Case Number
/ EPA Manager
Use Pattern
4099
Mark
Wilhite
CK
REGISTRANT'S
GDLN # DESCRIPTION COMPLIANCE/MRID EPA DECISION
61-1
Chemical Identity
417588G2
Pending
61-2(a)
Begin, mat. & mnfg. proc
41758802
Pending
61-2(b)
Discussion of Impurities
41758802
Pending
62-1
Preliminary Analysis
42261001
Pending
62-2
Certification of limits
Data Gap
62-2
Certification of limits
41758802
Pending
*"?-3
Analytical Method
Data Gap
Comments: The material you submitted for this guideline does
not address the requirement. The analytical procedure
you described does not apply to zinc chloride.
62-3
Analytical Method
41758802
Pending
63-2
Color
41758802
Pending
63-3
Physical State
41758802
Pending
63-4
Odor
41758 801
Pending
63-5
Melting Point
41758802
Pending
63-6
Boi1ing Point
41758802
Pending
63-7
Density
41758802
Pending
63-8
Solubility . .
41758802
Pending
63-9
Vapor Pressure
41758802
Pending
-v-IO
Dissociation Constant
41758802
Pending
o3 —12
pH
Data Gap
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission
Pg. 2
Chemical/Case Number
87801 / 4099
Company Number / Name
000802 CHAS H,
LILLY CO,
GDLN # DESCRIPTION
REGISTRANT'S
CGMPLIANCE/MRID
EPA DECISION
Comments: You reported two widely different values for pH in
two physical chemistry data submissions. You must
provide the correct value and explain the
discrepancy.
63-12 pH 41758801 Pending
63-13 Stability' 41758801 Pending
-------
P& 1 o f 2
United States Environmental Protection Agency-
Form Approved
Washington,
D.
Z. 20460
0MB Mo. 2070-0107
REQUIREMENTS STATUS
AND REGISTRANT'8 RESPONSE
Approval Expires 12-31*92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
on this form.
Use additional sheet(s)
if necessary
1. Company name and Address 000802
2.
Case # and Name
3. Date and Type of DO
CHAS H. LILLY CO.
4099 Zinc salts
GENERIC
7737 N.E. KILLINGSWORTH
Chemical # and name 527200
PORTLAND OR
1
97218
Zine Sulfate Monohydrate
4. Guideline
Requirement
Number
5. Study Title
j
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
P
1
2
3
61-1
Chemical Identity
all
TGAI
12
ItlOS *
61-2(a)
Begin, mat, & mrrfg. proc
all
TGAI
12
mos.
61-2(b)
Discussion of Impurities
all
TGAI
12
mos.
62-1
Preliminary Analysis
all
TGAI
12
mds.
62-2
Certification of limits
all
TGAI
12
mos.
62-3
Analytical Method
all
TGAI
12
mos.
63-2
Color
all
TGAI
12
BIOS,.
63-3
Physical State
all
TGAI
12
mos.
63-4
Odor
all
TGAI
12
mos,
63-5
Melting Point
all
TGAI
12
mos.
63-6
Boiling Point
all
TGAI
12
mos.
63-7
Density
all
TGAI
"l2;
- mos.
63-8
SolubiIi ty
all
TGAI
12
mos.
63-9
Vapor Pressure
all
TGAI '
12
63-10
Dissociation Constant
all
TGAI
12
mos.
63-12
PH
all
TGAI
12
mos.
63-13
StabiIi ty
all
TGAI
12
mos.
10. Certification
11. Date
I certify that the statements made on this form and nil attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
13, Phone Number
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission p<
| Company Number / Name CHAS H. LILL¥ CO,
00802 / Address Portland, OR
Chemical Hunter / Name
527200 Zinc sulfate monohydrate
Case Number / EPA Manager Use Pattern
4 099 Mark Wilhite CK
REGISTRANT'S
GDLN # DESCRIPTION COMPLIANCE/MRID EPA DECISION
61-1 Chemical- Identity'' Data Gap
61-2 (a) Begin, mat". & mnf g. proc Data Gap
61-2(b) Discussion of Impurities Data Gap
62-1 Preliminary Analysis Data Gap
62-2 Certification'-'of limits - Data Gap
62-3 Analytical Method Data Gap
63-2 Color Data Gap
j-3 Phyiical Stated-- Data Gap
63-4 Odor Data Gap
63-5 Melting Point Data Gap
63-6 Boiling Point Data Gap
63-7 Density Data Gap
63-8' Solubility Data Gap
63-9 Vapor Pressure.-,^-'- Data Gap
63-10 Dissociatiata Gap
63-13 Stability Data Gap
-------
Pa 1 of 2
United States Environmental Protection Agency
Form Approved
Washington,
D.C. 20460
0MB No. 2070-0107
REQUIREMENTS STATUS
AND REGISTRANT'S RESPONSE
Approval Expires 12-31-92
INSTRUCT IOMS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s)
if necessary
1. Company name and Address
z.
Case # and Name
3. Date and Type of DC!
Retta Mfg., Inc.
4099 Zinc salts
GENERIC
Box 2 3 06
97402
Chemical #
and Kane 527200
E-igone, OR
Zinc Sulfate Morahydrate
4. Guideline
5. Study Title
I
Progress
6. Use
7. Test
6.
Time
9. Registrant
Requirement
I
Reports
Pattern
Substance
Frame
Response
Number
V
2
1
2
3
61-1
Chemical Identity
all
TGAI
12
mos.
61—2 (S)
Begin, mat. & mrtfg. proc
all
TfiAI
12
lttoi-i •
61-2(b)
Discussion of Impurities
all
TGAI
12
mos.
62-1
Preliminary Analysis
all-
TGAI
12
moMi
62-2
Certification of limits
all
TGAI
12
mos.
62-3
Analytical Method
all
TGAI
12
mos
63-2
Color
all
TGAI
12
mos.
63-3
Physical State
ail
TGAI
12
mos.
63-4
Odor
all
TGAI
12
MOS.
63-5
Netting Point
ill
TGAI
12
mos. >
63-6
Boiling Point
all
TGAI
12
mos.
63-7
Oensity
lill
TtGAI'-
12
mos.
63-8
SoLubiIity
all
TGAI
12
mos.
63-9
Vapor Pressure
all
Tilt
12
:''-3iiss *¦
63-10
Dissociation Constant
all
TGAI
12
mos.
63-12
pH
all
TGAI
12
mos.
63-13
StabiIity
all
TGAI
12
mos.
10, Certification
11.
Date
1 certify that the statements made on this for* and all attachments are true, accurate, and complete.
1 acknowledge that any knoHingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12, Name of Company Contact
13.
Phone Number
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission ?g'
Company Nunber
J10 699
/ Name RETTA MFG. , INC.
/ Address EUGENE, OR
Chemical Number
527200
/ Name
Zinc sulfate monohydrate
Case Number
4099
/ EPA Manager Use Pattern
Mark Wilhite K
GDLN # DESCRIPTION
REGISTRANT'S
COMPLIANCE/MRID
EPA DECISION
61-1 Chemical Identity
Comments: This guideline appears as a data gap for another
registrant. It does not apply to you.
61-1 Chemical Identity 42233801 Pending
61-2(a) Begin, mat. & mrifg. proc
Comments: See comments for guideline 61-1.
L-2(a) Begin, mat. & mnfg. proc 42233801 Pending
61-2(b) Discussion of Impurities
Comments: See comments for guideline 61-1.
61-2(b) Discussion of Impurities 42233801 Pending
62-1 Preliminary Analysis Data Gap
Comments: In the sample analysis you submitted, you did not
account for the monohydrate. You must either
calculate the amount of all fractions or submit a new
method.
62-2 Certification of limits Data Gap
Comments: You must submit the upper, lower and nominal
concentrations of zinc sulfate monohydrate as well as
the upper and lower limit of each impurity of
toxicological concern.
:-2 Certification of limits 42233802 Pending
62-3 Analytical Method Data Gap
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission
Pg.
[—
"hefnica l/Case Nunber
Company Number / Maine
27200 / 4099
010699 RETTA
MFG., INC.
REGISTRANT'S
GDLN # DESCRIPTION
COMPLIANCE/MRID
EPA DECISION
Comments: In the analysis you submitted the water content was
not accounted for. You must revise this data
submission using another analysis or submit a new
method.
62-3 Analytical Method: 422 3 3802
63-2: Color
Comments: See comments for guideline 61-1.
Pending
63-2 Color ¦ 42252501
*3-3 Physical Stated-
Comments: See comments for guideline 61-1.
Pending
63-3 Physical Stated.-:" . 42252501 Pending
63-4 Odor
Comments: See comments for guideline 61-1.
63-4 Odor 42252501 Pending
63-5- Melting Point..
Comments: See comments for guideline 61-1.
63--S-
63-6
Melting Point
Boili rip; Po int
42252501
Pending
-------
U.S. Environmental Protection Agency
Response to Phase 3 submission
Pg.
3
Chemical/Case Number
27200 / 4099
Company Number / Name
010699 RETTA MFG., INC.
GDLN # DESCRIPTION
REGISTRANT'S
COMPLIANCE/MRIB
EPA DECISION
Comments: See comments for guideline 61-1.
63-6 Boiling Point 42252501 Pending
63-7 Density
Comments: See comments for guideline 61-1.
63-7 Density - 42252501 Pending
63-8 Solubility
Comments: See comments for guideline 61-1.
63-8 Solubility 42252501 • Pending
63-9 Vapor Pressure
Comments: See comments for guideline 61-1.
63-9 Vapor Prfeistiife ' 42252501 Pending
63-10 •• Dissociation:;:coril€EhE;::
Comments: See comments for guideline 61-1.
63-10
63-13
Dissociation Constant 42252501
Stability
Comments; See comments for guideline 61-1.
Pending
-------
U.S. Environmental Protection Agency
Response to Phase 3 Submission
1
"henti cat/Case Nunber
Company Number / Name
J27200 / 4099
010699 RETTA
MFG., INC.
REGISTRANT'S
GDLN # DESCRIPTION
COMPLIANCE/MRID
EPA DECISION
63-13
81-4
81-5
Stability-
Primary eye irration-rabbit
Primary derma l^i'frlfcat ion
42252501
42233803
42233804
Pending
Pending
Pending
-------
ATTACHMENT D
LIST OF ALL REGISTRANT(S) SENT THIS DCI
-------
List of All Registrants Sent This Data Call-in Notice
Case # and Name
4099 Zinc salts
Chemical M and Name
088502 Zinc oxide
Company Number Company Name Additional Name Address City 1 Stite Zip
003098 BAXTER J H R COMPANY 1700 S II CAHIN0 REAL SAN MATEO CA 94*02
050019 JAMES W. NIELSEN BOX 6669 BROOKINGS OR 97415
055500 WESPAC ENTERPRISES IMC 2415 S 200TH.ST BOX.46337 _ SEATTLS MA 98146 ,
058509 DAVID A. WALTZ IMPORTS D/B/A NENZIES SHEET KETAL 13903 S.F. UTH ST VANCOUVER WA 98684
-------
List of All Registrants Sent - ..is Data Call-in Not:ice
Case # and Name
4099 Zinc salts
Chemical # and Name
087801 Zinc chloride
Company Number Company Name Additional Name Address City & State Zip
000802 CHAS H. LILLY CO. 7737 N.E. KILLINGSWORTH PORTLAND OR 97218
-------
List of All Registrants Sent Data Call-in Notice
Case U and Name
4099 Zinc salts
Chemical # and Name
527200 Zinc sulfate monohydrate
Company Hunter Conpany Name
Additional Name
000802 CHAS H. LILLY CO.
10699 Retta Mfg.,Inc.
Address
City t State
lip
7737 H.E. KIIUHGSH0RTH
PORTLAND OR
97218
Box 2306
Eugene, OR
97402
-------
ATTACHMENT E
COST SHARE/DATA COMPENSATION FORMS
-------
f/EPA
United Stilts Environmental
Washington, DC
CERTIFICATION WITH
DATA COMPENSATION
Protection Agency
20460
RESPECT TO
REQUIREMENTS
Perm Approvtd
OUS No. 2070-01 ss
Appnvtl Eipir** l2.3t.Bl
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
lime tor reviewing instfusions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, Including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St.. S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please nil in blanks below.
GenpMy Nm»
Produce Name
EPA Rag. No.
1 Certify that:
1. For each study cited in support of registration or ^registration under the Federal Insecticide. Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study. 1 am the original data submitter, or 1 have obtained the
written permission of the original data submitter to cite that study.
2. That for each study died in support of registration or ^registration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or t
have notified in writing the oompany(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(c)(i)(0) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to (he compensation requirement of FIFRA and the amount of
compensation due, M any. The companies i have notified are:
I ] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants* Response Form,"
3. That f have previously complied with section 3(e)(1)(D) of FIFRA tor the studies I have sued in support of
registration or reregistration under FIFRA.
Signature
t
Oste
Nan* and Till# {Pins* Type w Print)
GENERAL OFFER TO PAY: t hereby offer and agree to pay compensation to other persons, wth regard to the
registration or reregistration of my products, to the extent required by FIFRA sections 3(e)(1)(D) and 3(c)(2)(D).
CPA SS7S-S1 (440)
-------
United States Invlronmental Protection Agency
A POA Washington, DC 20460
CERTIFICATION OF OFFER TO COST
IbI fm SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OHS No. 207(M)1Q«
Approval Esplraa li-si-si
Pubrc reporting burden for this collection of information it estimated to average 15 minutes per response, teuding
time tor reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions tor reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20480; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, IX 20503.
Pleas* fltf In blanks below.
Company Nam*
Product Maae
EPA leg. No.
1 Cartify that:
My company is willing to develop and submit the data required by EPA undtr the authority of the Federal
Insecticide. Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data
My firm has offered tn writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B){liI) of FIFRA If final agreement on all
terms eouid not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Nsm •( ffrm(t)
i
bate ef Offer
1 certify that lam duly autNjrtzed to represent the company named stevt, and that the statements that I have made on
Uftfofmindiii attachmtnti thinin am taw, accural*, and compJtti. 1 acknowitdgi that any knowingly fain or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
|tl|MttM •( Company'! AuiJwrfsetf RtprMMiailva
Data
Mum ani till* (?!•••• Type * Print)
SPA form II70-J2
-------
APPENDIX G
Product Specific Data Call-in
-------
(mj
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 30460
DATA CALL-IN NOTICE
CERTIFIED MATT,
OFFICE OF
pcamcoei *» toxic
•UUTANCiS
Dear Sir or Madam i
Tirs Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-in Chemical Status
Sheet, to submit certain product specific data as noted herein to
the U.S. Environmental Protection Agency (EPA, the Agency).
These data are necessary to maintain the continued registration
of your product(s) containing this active ingredient. Within 90
days after you receive this Notice you must respond as set forth
in Section III below. Your response must state:
1. How you will comply with the requirements set forth in
this Notice and its Attachments A through G; or
2. Why you believe you are exempt from the requirements
listed in this Notice and in Attachment c,
Requirements Statue and Registrant's Response Form, (see
section III-B)i or
3. Why you believe EPA should net require your submission
of product specific data in the manner specified by this
Notice (see section 111-0}.
If you do not respond to this Notice, or if you do not
satisfy EPA that you will comply with its requirements or should
be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension.
Wt havt provided a list of all of your products subject to this
Notice in Attachment B, Data Call-in s«iBon«t Form, as well as a
list of all registrants who were sent this Notice (Attachaent T).
The authority for this Notice is section 3(c)(2)(B) of the
Federal Insecticide, Fungicide and Rodenticide Act as amended
(FIFRA), 7 U.S.C. section I36a(c)(2)(B). collection of this
information is authorized under the Paperwork Reduction Act by
0MB Approval No, 2070-0107 (expiration date 12-31-92).
-------
2
This Notice is divided into six sections and seven
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-In Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are*
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section XII - Compliance With Requirements Of This
Notice
Section IV - Consequences Of Failure To comply With
This Notice
Section V - Registrants' Obligation To Report
Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
a - pata.callrln cfteaical Status Sheet
b - Pats Call-In Respcnse fcra
c - Represents States and Registrant's Response Fcra
D - EPA grouping of Bnd«Use Products for Meeting Acute
Toxicology Data Requirements for Registration
£ - SPA acceptance Criteria
f - Ust vt Registrants Receiving Tftlg.Hctlc*
s - ccst Share and Pata Ccgpensatlcn rcrag, ana Product
Specific Pata Repcrt Fcrro
SECTION I. YQg.ARS BSCKVIPg THIS PCTICS
The Agency* has reviewed existing data for this active
ingredient end reevaluated the data needed'to support continued
registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product
specific data. No additional generic data requirements are being
imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION XX. PATA REQUIRED BY THIS NOTICE
xi-A. flKSh RJSQV1RSP
The product specific data rsquirsd by this Notice are
specified in AttiChaent C, Requirements Status and Raalstrant'a
BWOn*t Fora- Depending on the result* of the studies required in
this Notice, additional, testing say be required.
-------
3
XI-B. SCHEDULE FOR SUBMISSION OF DATA
You art required to submit the data or otherwise satisfy the
data requirements specified in Attachment C, Requirements status
and Registrant's Response Warm, within the timeframes provided.
II-C. testing protocol
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established.
These SPA Guidelines are available from the National Technical
Information Service (NTIS), Attn: order Desk, S285 Port Royal Road,
Springfield, Va 23161 (tel: 703-487-4650),
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the OECD-
recomaended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR S 156.70). When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study vill satisfy the requirements
of 40 CFR S 158. Normally, the Agency will not extend deadlines
for complying vith data requirements when the studies were not
conducted in accordance vith acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
All new studies and proposed protocols submitted in response
to this Data Call-In Notice must be in accordance vith Good
Laboratory Practices (40 CFR Part 160.3(a)(6)].
XI-D- REGISTRANTS RECEIVING PREVIOUS SECTION 3feW2HB1 NOTICES
. ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data call-in does not In
anv way supersede or chance the remiireaents of anv previous Data
Call-infs^. or any*other agreements entered into vith the Agency
pertaining to such prior notice. Registrants wist coaply with the
requirements of all Notices to avoid issuance of a Notice of Intent
to Suspend their effected products.
SECTION III. CQMPUAKCE WITH REQUIREMENTS OF TOTS NOTICE
IXI-A. SCHEDPU FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice
for product specific data must be submitted to the Agency within 90
days after your receipt of this Notlee. Failure to adequately
respond to this Notice within 90 days of your receipt will be a
basis for issuing a Notice of Intent to Suspend (N0IS) affecting
-------
A
your products. This and other bases for issuance of HOIS due to
failure to comply with this Notice are presented in Section iv-a
and XV-B.
"*-»• OPTIONS rPR BBSPOEPIPg TO „m, MBttg
The options for responding to this Notice for product specific
data are: (a) voluntary cancellation, (b) agree to satisfy the
product specific data requirements imposed by this Notice or (c)
request a data waiver(s).
A discussion of how to respond if you choose the Voluntary
Cancellation option is presented below. A discussion of the
~ various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C. A
discussion of options relating to requests for data waivers is
contained in Section III-D.
There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency. These forms are the Qata-Call-In FCSgCTSS
lam* and the Rgquirmnts Status and Rgqlstirant'g Btsggns?fow.
Attachment B and Attachment C. The Data Call-In Response Form must
be submitted as part of every response to this Notice. In
addition, one copy of the Btwigmntff status an4 Registrant !.s
Response Form must be submitted for each product listed on the
pfrta Call-In ftespgnse FCglft unless the voluntary cancellation option
is selected or unless the product is identical to another (refer to
the instructions for completing the Pita Call-In RfSPOnst Form in
Attachment B). Please note that the company's authorized
representative is required to sign the first page of the Data Call-
in Response Form and Retirements Status and Registrant's Response
Form (if this form is required) and initial any subsequent pages.
The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions
or need assistance in preparing your response, call or write the
contact person(s} identified in Attachment A.
2. ypmntary Cangtllatlen - You may avoid the requirements of
this Notice by requesting voluntary cancellation of your product(s)
containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must
submit a completed Data Call-In Response Form, indicating your
election of this option, voluntary cancellation is itaa number 5
on th« Data Call-In laieonit Form. If you choose this option, this
is the only form that you are required to complete.
If you choose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
cancellation must be in accordance with the Existing stocks
provisions of this Notice which are contained in Section XV-C.
-------
2. Satisfying the Product Specific Data Reoulaments of this
Notice. There are various option* available to satisfy the product
specific data requirements of this notice. These options are
discussed in Section IIX-C of this notice and comprise options 1
through 6 on the Riq\ilri»cnti Statm and BtfllgtranV* Rtgpgnat Tarn
and item numbers 7a and 7b on the Data Call-in Response Form.
Deletion of a use(s) and the low volume/minor use option are not
valid options for fulfilling product specific data requirements.
3* Bequest for Product Specific Data Waivers. Waivers for
product specific data are discussed in Seetion Ill-D of this Notice
and are covered by option 7 on the BfOTlrwntf .Statu*,
BtqjStranVa Rtggpnff Tvm* If you choose this option, you must
submit both forms as veil as any other information/data pertaining
to., the option chosen to address the data requirement.
iir-e sATSsmyg the data RiogiKEKarrs or this notice
If you acknowledge on the Pata Call-in Kwgllft For* that you
agree to satisfy the product specific data requirements (i.e. you
select option 7a or 7b), then you must select one of the six
options on the Riottirtatnti Statug and Registrant's Rtspgng* Form
related to data production for each data requirement. Your option
selection should be entered under item number 9, "Registrant
Response." The six options related to data production are the
first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response Form.
These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions
provided in this Seetion. The options are:
(1) Z will generate and submit data within the specified
timeframe (Developing Data)
(2) I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing}
(3) I have made offers to cost-share (Offers to Cost Share)
(4) Z am submitting an existing study that has not been
submitted previously to the Agency by anyone (Submitting
an Existing Study)
(5) I aa submitting or citing data to upgrade a study
classified by EPA as partially acceptable and upgradeable
(Upgrading a Study)
(6) I am citing an existing study that EPA his classified as
acceptable or AS existing Study that has been submitted
but not reviewed by the Agency (Citing an Existing Study)
Option l. Developing Data — If you choose to develop the
required data it must be in conformance with Agency deadlines and
with other Agency requirements as referenced herein and in the
attachments. All data generated and submitted must comply with the
Good Laboratory Practice (CLP) rule (40 em Part 160), be conducted
according to the Pesticide Assessment Guidelines (PAG), and be in
conformance with the requirements of PR Notice 86-5.
-------
6
The time frames in the SEafcttt 6Hfl RfgigttWt'.f
Response Form are the time frames that the Agency is allowing for
the submission of completed study reports. The noted deadlines run
from the date of the receipt of this Notice by the registrant. If
the data are not submitted by the deadline, each registrant is
subject to receipt of a Notice of Intent to Suspend the affected
registration(s).
If you cannot submit the data/reports to the Agency in the time
required by this Notice and intend to seek additional tiae to meet
the requirements (s), you must submit a request to the Agency which
includes: (1) a detailed description of the expected difficulty and
(2) a proposed schedule including alternative dates for meeting
such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from
the laboratory performing the testing. While EPA is considering
your request, the original deadline remains. The Agency will
respond to your request in writing. If EPA does not grant your
request, the original deadline remains. ' Normally, extensions can
be requested only in cases of extraordinary testing problems beyond
the expectation or control of the registrant. Extensions will not
be given in submitting the 90-day responses. Extensions will not
be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.
Option 2. Aaree to Share in Cost to Develop Data —Registrants
nay only choose this option for acute toxicity data and certain
efficacy data and only if EPA has indicated in the attached data
tables that your produet and at least one other product are similar
for purposes of depending on the same data. If this is the case,
data may be generated for just one of the products in the group.
The registration number of the product for which data will be
submitted must be noted in the agreement to cost share by the
registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but
will not be submitting the data yourself, you must provide the name
of the registrant vho will be submitting the data. You must also
provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a
written statement by the parties that an agreement exists. The
agreement to produce the data need not specify all of the terms of
the final arrangement between the parties or the mechanism to
resolve the terms. Section 3(c)(2)(8) providai that if tht partias
cannot rasolva the tans of the agreement they nay resolve their
differences through binding arbitration.
Option 3. ottmr to Share in the Cost of Data Development —
This option only applias to acute toxicity and certain efficacy
data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing
agreement to meet the requirements of this Notice and have been
-------
1
7
unsuccessful, you may request EPA (by selecting this option) to
exercise its discrstion not to suspend your registration(s),
although you do not comply with the data submission requirements of
this Notice. EPA has determined that as a general policy, absent
other relevant considerations, it vill not suspend the registration
of a produet of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data
has refused to accept your offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made
an offer to another registrant (who has an obligation to submit
data) to share in the burden of developing that data. You must
also submit to the Agency a completed SPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data,
Attachment 6. In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer
to enter into a costsharing agreement by including a copy of your
offer.and proof of the ether registrant's receipt of that offer
(such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the.
data upon terms to be agreed or failing agreement to be bound by
binding arbitration as provided by FZFRA section 3(c)(2)(1)(iii)
and must net qualify this offer. The other registrant must also
inform SPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data Call-in Response
£213 »nd a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may
not withdraw your offer to share in the burdens of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice. Zf the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject to
initiation of suspension proceedings, unless you commit to submit,
and do submit the required data in the specified time frame, in
such cases, the Agency generally will not grant e time extension
for submitting the data.
Option 4. Submitting an Existing Study If you choose to
submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this
Notice. You say only submit ft study that has not bean previously
submitted to the Agency or previously cited by anyone. Existing
studies are studies which predate issuance of this Notice. Do not
use this option if you are submitting data to upgrade e study. (See
Option 5).
You should be aware that if the Agency determines that the
study is not acceptable, the Agency will require you to comply with
this Notice, normally without an extension of the required date of
submission. The Agency may determine at any time that a study is
not valid and needs to be repeated.
-------
8
To meet the requirements of the DCI Notice for submitting an
existing study, all of the following three criteria must be clearly
8£&:
a. You must certify at the time that the existing study is
submitted that the raw data and specimens from the study are
available for audit and review and you must identify where they
are available. This must be done in accordance vith
the requirements of the Good Laboratory Practice (GLP)
regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(j)
* •[rjaw data1 means any laboratory worksheets, records,
¦ memoranda, notes, or exact copies thereof, that are the result
of original observations and activities of a study and are
' necessary for the reconstruction and evaluation of the report
of that study. In the event that exact transcripts of raw data
- have been prepared (e.g., tapes which have been transcribed
¦ verbatim, dated, and verified accurate by signature), the exact
copy or exact transcript may be substituted for the original
source as raw data. 'Raw data' may include photographs,
microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from
automated instruments.*1 The term "specimens'*r according to 40
CFR 160.3(k), means "any material derived from a test system
for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the
existing study that such GLP information is available for post-
May 19i4 studies by including an appropriate statement on or
attached to the study signed by an authorized official or
representative of the registrant.
c. You must certify that each study fulfills the acceptance
criteria for the Guideline relevant to the study provided in/^^,^,^
the FX7RH Accelerated Reregistration Phase 3 Technical Guidance A
and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of
the PAG (both available from KTIS). A study not conducted
according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly
seats the purpose of the PAG. The registrant is referred to 40
CFR 1S8.70 which states the Agency's policy regarding
ecceptable protocols. Zf you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you
believe the study meets the purpoee of the PAG, including
copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
-------
9
If you submit an existing study, you must certify that the
study seats all requirements of the criteria outlined atoova.
If you know of a study pertaining to any requirement in this
Notice which does not aeet the criteria outlinad above but does
contain factual information regarding unreasonable adverse effects,
you aust notify tlie Agency of such a study. If such study is in
the Agency*s files, you need only cite it along with the
notification. If not in the Agency's files, you aust subait a
summary and copies as required by PR Notice 86-5.
, Option 5. Upgrading a Study — if a study has been classified
as partially acceptable and upgradeable, you say subait data to
upgrade that study. The Agency will reviev the data submitted and
determine if the requirement is satisfied. If the Agency decides
the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient,
but upgradeable studies will normally be classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a
study may be upgraded, call or write the contact person listed in
Attachment A« If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA.
Your submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and aust be in conformance with
PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a
study classified as unacceptable and determined by the Agency as
not capable of being upgraded.
This option should also be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency, you aust provide the KRID number of the
data submission as wall as tha KRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in
option 4 above, apply to all data submissions intendad to upgrade
studias. Additionally your submission of data intended to upgrade
studies aust ba accompanied by a certification that you eemply with
each of those criteria as well as a certification regarding
protocol compliance with Agency requirements.
Option ft citing Exi»tinq Stldi« — If you choose to cite a
study that has been previously submitted to EPA, that study must
.lave been previously classified by SPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable
-------
10
toxicology studies generally will have been classified as "core-
guideline* or "core minimum." For all other disciplines the
classification would be "acceptable.** ' with respect to any studies
for which you wish to select this option you must provide the MRID
number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original
data submitter, you must submit a completed copy of EPA Form
8570-31, Certification with Raapget to Data Compensation
Requirement".
¦¦ Registrants who select one of the above 6 options must meet all
of the requirements described in the instructions for completing
th« Data. Call-in Response Form and the Keqvlrfffgntfi
Registrant's Response Form, as appropriate.
I-^I—D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you
believe it is inappropriate, you must attach a complete
justification for the request, including technical reasons, data
and references to relevant EPA regulations, guidelines or policies.
(Note: any supplemental data must be submitted in the format
required by PR Notice 86-5). This will be the only opportunity to
-state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will net
be required to supply the data pursuant to section 3(c)(2)(&} of
FZFRA. If the Agency denies your waiver request, you must choose
an option for meeting the data requirements of this Notice within
30 days of the receipt of the Agency's decision. You must indicate
and submit the option chosen on the Reouirewents status and
Registrant's Response Form. Product specific data requirements for
product chemistry, acute toxicity and efficacy (where appropriate)
are required for all products and the Agency will grant a waiver
only under extraordinary circumstances. You should also be aware
that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the
original due date will remain In force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
XV-A MM 0? ivmn to suspend
The Agency nay issue a Notice of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the following:
-------
11
1. Failure to respond as required by this notice within so
days of your receipt of this Notice.
2. Failure to submit on the required schedule an acceptable
proposed or final protocol if such is required to be submitted
to the Agency for review.
3. Failure to subait on the required schedule an adequate
progress report en a study if required by this Notice.
4. Failure to submit on the required schedule acceptable
data as required by this Notice.
5. Failure to take a required action or submit adequate
information pertaining to any option chosen to address the data
requirements (e.g., any required action or information
pertaining to submission or citation of existing studies or
' offers, arrangements, or arbitration on the sharing of costs or
the formation of Task Forces, failure to comply with the terms
of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data
waiver).
C. Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section XII-C
of this Notice.
7. Withdrawal of an offer to share in the cost of developing
• required data.
S. Failure of the registrant to whom you have tendered an offer
to share in the cost of developing data and provided proof of
the registrant's receipt of such offer either to:
a. Inform SPA of intent to develop and submit the data
required by this Notice on a Data Call-in Response Form and a
Rtwlrtitnta Statui and Rtqigtrant'i Rsgpsnat Formi
b. Fulfill the commitment to develop and submit the data as
required by this Notice; or
* c. Otherwise take appropriate steps to meet the requirements
stated in this Notice, unless you commit to submit and do
submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of this
Notice.
xv-b. basis tm vvmrnmnw thatsyraimp sttoy is.
WAcamra
The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for
-------
12
lssuanc« of a Notice of Intent to Suspend. The grounds for
suspension include, but'are not limited to, failure to meet any of
the following:
1* EPA requirement* specified in the Data Call-In Notice or
other documents incorporated by reference (including, as
applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required
studies. Such requirements include, but are not limited to,
, those relating to test .material, test procedures, selection of
species, number of animals, sex and distribution of animals,
dose and effect levels to be tested or attained, duration of
. test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols (if
- applicable), including the incorporation of any changes
required by the Agency following review.
?
3. SPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted
in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
xv-c EXISTS?"? ST9CTS Qf §V§?EWED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale,
distribution and use of existing stocks of a pesticide product
which has been suspended or cancelled if doing, so would be
' consistent with the purposes of the Act. •
me Agency has determined that such disposition by registrants
of existing stocks for a suspended registration when a section
3(c)(2)(B) data requ est is outstanding would generally not be
consistent with ttop Act's purposes. Accordingly, the Agency
anticipates granting registrants permission to sell, distribute, or
use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks
of your product(s) which may fas suspended for failure to comply
with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be
consistent with the Act. You must also explain why an "existing
stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required
for their sale, distribution, and use. Unless you meet this burden
the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after
suspension.
If you request a voluntary cancellation of your product(s) af r
response to this notice and your product is in full compliance with
-------
13
All Agency requirements, you will have, under most circumstances,
on* year from the data your 90 day response to this "Notice is due,
to sail, distribute, or us* existing stocks. Normally, tha Agency
will allow persons other than the registrant such as independent
distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks ere exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular
risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day
response period required by .this Notice will not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year froa the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before SFA will consider granting an existing stocks
provision.
SECTION V. BISISTWrS' PBHCATIPP TO REPORT F05SIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FZFRA section 6(a)(2) states that
if at any time after a pesticide is registered a registrant has
additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, tha registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency.
SECTION VI. INOPIRIES AND RESPONSES TO THIS MQfrTffl
Zf you have any questions regarding the requirements and
procedures established by this Notice, call the contact person(s)
listed in Attachment A, the Data Call-in Chemical Status Sheet.
Ail responses to this Notice (other than voluntary cancellation
requests) must include a completed Data Call-in Rfgpgngf fQIM «*d «
completed Requirements Status and Registrant's Response Form
{Attachment S and Attachment C) and any other documents required by
this Notice, and should be submitted to the contact person(s)
Identified in Attachment A. Zf the voluntary cancellation option is
chosen, only the Data Call-In Response Form need be submitted.
-------
14
The Office of Coapliance Monitoring (OCM) of the Office of
Pesticides and Toxic Substances (OPTS), SPA, will be monitoring the
data being generated in response to this notice.
A - Beta Call-in Cheaical Status Sheet
» - Data Call-In Response Form
c - BtqBigfflfflfri gtfttig and BtqigtranVg Rtgpong* Eerm
D - EPA Grouping of End-Use Products for Meeting Acute
Toxicology Pat-a Rtouirtatntg for RfEftgiBtratlon
s - EPA Acctptangc crittrla
r - hist Qt Rtgjgtrantg Rscfiyinq Thlg Fotic*
G - Cost Share and Data Compensation Forms, and Product
Sgtoific Pata Rtport form
Sincerely yours
Daniel H. Barolo, Director
. Special Review and
Reregistration Division
Attachments
-------
ATTACHMENT A
ZINC SALTS: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing zinc salts.
This Product Specific Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of zinc
salts. This attachment is to be used in conjunction with (I) the Product Specific Data Call-in
Notice, (2) the Product Specific Data Call-in Response Form (Attachment B), (3) the
Requirements Status and Registrant's Form (Attachment C), (4) EPA's Grouping of End Use
Products for Meeting Acute Toxicology Data Requirement (Attachment D), (5) the EPA
Acceptance Criteria (Attachment E), (6) a list of registrants receiving this DCI (Attachment F)
and (7) the Cost Share and Data Compensation Forms in replying to this zinc salts Product
Specific Data Call-in. (Attachment G). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for zinc salts are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional data on zinc salts are needed for specific products. These data are
required to be submitted to the Agency within the timeframe listed. These data are needed to
fully complete the reregistration of all eligible zinc salts products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of zinc salts, please contact
Mark Wilhite at (703) 308-8086.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Joanne Miller (703) 305-7830.
-------
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Joanne Miller, Product Manager Team 23
Herbicide/Fungicide Branch
Registration Division (R7505C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: ZINC SALTS
-------
ATTACHMENT B
PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
PLUS INSTRUCTIONS
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE DATA CALL-IN RESPONSE FORM
Product specific Data
This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act, Fill out this form each time you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form. Items 1
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
INSTRUCTIONS 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 (HP)
or 7b (EP) on this form, provide the EPA registration
numbers of your source(s) and complete and submit the
"Generic Data Exemption" form; you would not complete
the "Requirements Status and Registrant's Response"
form. Examples of such products include repackaged
products and Special Local Needs (Section 24c) products
which are identical to federally registered products.
Item 7a. For each manufacturing use product (MP) for which you
wish to maintain registration, you must agree to
satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EP) for which you wish to
maintain registration, you must agree to satisfy the
data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in
addition, on the "Requirements Status and Registrant's
Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you
are requesting a waiver. See Item 6 with regard to
identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not
fit on this form in a signed letter that accompanies
this form. For example, you may wish to report that
your product has already been transferred to another
company or that you have already voluntarily cancelled
this product. For these cases, please supply all
relevant details so that EPA can ensure that its
records are correct.
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM
Product Specific Data
This form is designed to be used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act, Although the form is the same for
both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1)
deletion of uses or (2) request for a low volume/minor use
waiver. These instructions are for completion of product
specific data requirements.
EPA has developed this form individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of items. DO NOT use this form for any other
active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on
-he form. You must complete all other items on this form by
typing or printing legibly.
Public reporting burden for this collection of information
is estimated to average 3 0 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-22 3, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
Page X of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print iri ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
OMB Do. 2070-0107
Approval Expires 12-31*92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sbeet(s> if necessary.
1. Caipany name and Address
DAVID A. WALTZ IMPORTS
D/B/A MENZIES SHEET METAL
13903 S.E. 14TH ST
VANCOUVER WA. 98684
2. Case 0 and Name
4099 line salts
3. Date and Type of DCt
PRODUCT SPECIFIC
4. EPA Product
Registration
5. i wish to
cancel thin
product regis-
tration volun-
tarily.
6. Generic Data
7, Product Specific Data
4a. I am claining a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration router listed below.
6b. I agree to satisfy Generic
Oata requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
?a. My product i» a HUP and
I agree to satisfy the HUP
requirements on the attached
font entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
58509-1
N.A.
N.A.
8. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Conoanv's Authorized Representative
9. Date
10. Name of Company Contact
It. Phone Nuriwr
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. c. 20460
DATA CALL-IN RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
IiSTRUCTIONS; Please type or print in Ink. Please read carefully the attached instructions and supply the information respiented on this torn.
Use additional sheet(s) if necessary.
1. Company name and Address
CANADIAN ROOFING PRODUCTS
5555 SALISH RD
BLAINE WA 98250
2. Case # and Name
4099 Zinc salts
3, Bate and Type of DC1
PRODUCT SPECIFIC
4. EPA Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tari ly.
6. Generic Data
7. Product Specific Data
6a. 1 am claiming a Generic
Date Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is a HUP and
I agree to satisfy the (UP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. Wy product is an EUP and
I agree to satisfy the EOP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
58494-1
N. A.
N. A.
8. Certification
1 certify that the statements made on this form and alt attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10. Name of Company Contact
11. Phone Number
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address
WESPAC ENTERPRISES INC
2415 S 200TH ST BOX 46337
SEATTLE WA 9814 6
2, Case # and Name
4099 Zinc salts
3. Date and Type of DC I
PRODUCT SPECIFIC
4. EPA Product
R eg i s t r a t i ofi
5. I wish to
cancet this
product regis-
trati on volun-
tary t y.
6. Generic Data
7. Product Specific Data
6a. I am claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. 1 agree to satisfy Generic
Oats requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is a MUP and
] agree to satisfy the HUP
requi remerits on the attached
form entitled "Requirements
Status and Registrant's
Response,"
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
55500-1
N. A.
N, A,
¦
8. Certification
1 certify that the statements made on this form and all attachments are true, accurate, and complete,
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisorment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10, Name of Company Contact
11. Phone Number
-------
Page 1 of l
United States Environmental Protection Agency-
Washington, D. C. 20460
DATA CALL-IN RESPONSE
form Approved
QNB No. 2070-0107
Approval Expires 12*31-92
INSTRUCTIONS: Please type or print in ink. Please read corefully the attached instructions arid supply the information requested on this for*.
Use additional sheet (s) if necessary.
1. Conpany name and Address
BAXTER J 1 & COMPANY
1700 S EL C AMI NO REAL
SAN MATEO CA 94402
2, Case # and Name
4099 Zinc salts
5. Date and Type of DCl
PRODUCT SPECIFIC
4. EPA Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily.
6, Generic Data
?. Product Specific Data
6a, I m claiming a Generic
Data Exenption because I
obtain the active ingredient
from the source EPA regis-
tration nunber listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a, My product fs a MP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b, tty product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
3098-18
N.A.
N.A.
8, Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete,
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisoranerrt
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10, Same of Company Contact
11. Phone timber
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
OHB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached Instructions and supply the information requested on this form.
Use additional sheets) if necessary.
1. Company name and Address
CHAS H. LILLY CO.
7737 N.E. KILLINGSWORTH
PORTLAND 01 97218
2. Case # and Name
4099 Zinc salts
3. Date and Type of DCl
PRODUCT SPECIFIC
4. EPA Product
Registration
5. 1 wish to
cancel this
product regis-
tration volun-
tarily.
6, Generic Data
7. Product Specific Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-,
tration rwriber listed below.
6b, I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. Hy product is an EUP and
I agree to satisfy the EUP
requirements on the attached
fori# entitled "Requirements
Status and Registrant's
Response."
802-591
N.A.
N.A.
8, Certification
1 certify that the statements made on this form ard all attachments are true, accurate, and conplete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10. Name of Company Contact
11, Phone Nuilser
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
0KB No. 2070-0107
Approval Expire® 12-31-92
INSTRUCTIONS; Please type or print in ink, Please read carefully the attached Instructions and supply the Information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address
CHAS H. LILLY CO.
77 3 7 N.E. KILLINGSWORTH
PORTLAND 01 97218
2. Case # and Name
4099 Zinc salts
3. Date and Type of DC1
PRODUCT SPECIFIC
4. EPA Product
Registration
5. 1 wish to
cancel this
product regis-
tration yoHun-
ter i ly.
6. Generic Data
?. Product Specific Data
6b. ! am ctaimimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration mmtoer listed below.
6b. 1 agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
1 agree to satisfy the EUP
requi rements on the attached
form entitled "Requirements
Status and Registrant's
Response."
802-553
N. A.
N» A.
8, Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete,
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
tO. Name of Company Contact
11. Phone Nwfcer
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
0MB No. Z070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Pleas* read carefully the attached instructions and supply the information requested on this form.
Use additional sheetCs) ff necessary.
1. Company name and Address
CHAS H. LILLY CO.
7737 N.E. KILLINGSWORTH
PORTLAND OR 97218
2. Case # and Name
4099 Zinc salts
3, Date arid Type of DCI
PRODUCT SPECIFIC
4. EPA Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tary ly.
6. Generic Data
7. Product Specific Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7a. My product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
802-508
N. A.
N. A.
8. Certification
I certify that the statements made on this form and all attachments are true, accurate, and cooplete.
t acknowledge that any knowingly false of misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10. Name of Company Contact
11. Phone number
-------
Page 1 of 1
United states Environmental Protection Agency
Washington, D. C, 20460
DATA CAT.L-IN RESPONSE
Form Approved
0MB No. 2070-010?
Approval Expires 12-31-91
INSTRUCTIONS; Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet ff necessary.
1. Company name and Address
MONSANTO CO.
700 14TH STREET, N.W. SUITE 1100
WASHINGTON DC 20005
2, Case i and Name
4099 Zinc salts
3. Oat# and type of DEI
PRODUCT SPECIFIC
4, EPA Product
Registration
5. 1 wish to
cancel this
product regis-
tration volun-
tari ly.
6. Generic Data
7. Product Specific Data
6a. I a* claimimg a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b, I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7m. My product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
524-354
N.A.
N.A.
•
8. Certification
1 certify that the statements made on this form and all attachments are true, accurate, and complete,
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisorment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10. Name of Company Contact
11. Phone Nunber
-------
Page 1 of 1
United States Environmental Protection Agency-
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
0KB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please rend carefully the attached instructions and supply the information requested on this form.
Use additional shect(s) ff necessary.
1. Company name and Acid res s
JAMES W. NIELSEN
BOX 6669
BROOKINGS OR 97415
2. Case # and Name
4099 Zinc salts
3. Date and Type of DCI
PRODUCT SPECIFIC
4. EPA Product
Registration
5. 1 wish to
cancei this
product regis-
tration votun-
tarily.
6. Generic Data
7. Product Specific Data
6a. i am claiming a Generic
Data Exemption because I
obtain the active ingredient
from tha source EPA regis- -
tration number Listed below.
6b, I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status arid
Registrant's Response."
7a. Ky product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response,"
7b. My predict is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requfrements
Status and Registrant's
Response."
50019-1
N.A.
N.A.
8. Certification
I certify that the statements made on this form and atl attachments are true, accurate, and confjtete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, iwprisonment
or both under applicable law.
Signature and Title of Conpany's Authorized Representative
9. Date
10. Name of Company Contact
11. Phone Number
-------
ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
FORMS (Form B) PLUS INSTRUCTIONS
AND
PR NOTICE 86-5
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM
Product Specific Data
This form is designed to be used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA's rcrcgistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for
both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1)
deletion of uses or (2) request for a low volume/minor use
waiver. These instructions are for completion of product
specific data requirements.
EPA has developed this form individually for each data call-
in, addressed to each registrant, and has preprinted this form
with a number of items. DO NOT use this form for any other
active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on
the form. You must complete all.other items on this form by
typing or printing legibly.
Public reporting burden for this collection of information
is estimated to average 3 0 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C, 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
Page 1 of
United States Environmental Protection Agency
Washington, D. C. 2 0460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
0MB Ho. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply *he information requested on this form.
Use additional sheetts) if necessary.
1. Company name and Address
JAMES W. NIELSEN
BOX 6669
BROOKINGS OR 97415
4. Guideline
Requi rement
Number
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-7
63-12
63-14
5. Study Title
Prod Chew - Regular Chemical
Product identity & composition^)
Descrip of starting materials,(1,2)
production & formulation
proc
Discussion of formation of (1,3)
inpurities
Preliminary analysis (1,4)
Certification of limits 0,5);
Analytical method (1)
Color
Physical state
Odor
Density
pH " (9) '
Oxidizing or reducing action (10)
2. Case # and Name
4099 Zinc salts
EPA Reg. No. 50019-1
Progress
Reports
6. Use
Pattern
ABODE FGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKUINO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
Substance
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 50019-RD-2379
8. Time
Frame
8
mos.
8
IQOS.
8
mos.
8
mos.
8
mos.
8
mos.
8
mos.
8
mos.
8
mos >:
8
mos.
8
mos.
8
mos.
9. Registrant
Response
10. Certification
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, inprisorraent
or both under applicable law.
Signature and Title of Conpeny's Authorized Representative ,
11. Date
12. Name of Company Contact
13. Phone Number
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS; Pleas# type or print In Ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
Form Approved
0MB No. 2070-0107
Approval Expires 11*31-92
1. Company rtaroe and Address
JAMES W. NIELSEN
BOX 6669
BROOKINGS OR 97415
Case # and Name
4099 Zinc salts
IPA Reg. No. 50019-1
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 50019-RD-2379
4. guideline
Requirement
Nuifeer
5. Study Title
Progress
deports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Resistrant
Response
63-15
63-16
63-17
63-18
63-19
63-20
63-21
81-1
81-2
81-3
81-4
81-5
Flanrnability (11)
ExplodabiI i ty (12)
Storage stabiIity
Viscosity (13)
Miseibility (14)
Corrosion characteristics
Dielectric breakdown voltage (15)
Acute Toxic - RtreutBrChewical
-Acute oral" tdklfelty-fat {1,36,373
Acute dermal (1,2,37)
toxicity-rabbit/rat
Acute inhalation toxicity-rat (3)
Primary eye irritation-rabbit (2)
Primary dermal irritation (1,21
Dermal sensitization (4)
ABCDEFGH1JKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHUKtMNO
ABClMFSHlJKIjDfQ
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABGDEfGHItKtlINO
MP/EP
MP/EP
MP/EP
MP/IP
MP/EP
MP/EP
EF
MI?JEP
MP/EP
MP/EP
MP/EP
MP/EP
MP/IP
Initial to indicate certification is to information on this put#
(full text of certification is on page or*).
Date
8 mos.
8 mos.
8 mos.
8 mos,
8 mos.
8;mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 hips.
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Key: HP = manufacturing-use product; EP = end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the proAict does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.!; TEP = typical end-use product;
TGAI = technical grade of the active ingredient; PA I = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop 1 - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N • Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in colum two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Chen - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and composition (61-1); *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of inpurities (61-J); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 Required to support the registration of each manufacturing-use product (including registered TGAls) as well as end-use products produced by an Integrated system.
Data on other end-use prodjcts m il be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive,
13 Required if product is a liquid.
14 Required if product is an emulsifiabie liquid and is to be diluted with petroleun solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Chenical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the product consists of, or uider Conditions of u. e will result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, siiichronic, and/or chronic) is required for organophospates, and may be required for other cholinesterase inhibitors and other pesticides
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name; 4099 Zinc salts
Footnotes (cont.):
which have demonstrated a potential to adversely affect the visual system, Registrants should consult with the agency for development of protocol# and methodology
prior to initiation of studies,
37 Testing of tfie EP dilution is required if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.1713(b) or the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D, C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expire# 12-31-92
I INSTRUCTIONS: Pleas® type or print in ink. Please read carefully the attached instructions and supply the Information requested on this form.
Use additional sheet{s} if necessary.
1. Company name and Address
MONSANTO CO.
700 14TH STREET, N.W.
WASHINGTON DC 20005
SUITE 1100
Case # and Name
4099 Zinc salts
EPA Reg. No. 524-354
3. Date and Type .of DC I
PRODUCT SPECIFIC
ID# 524-RD-2377
4, Guide!ino
5. Study Title
T~
R
Progress
6. Use
7. Test
8. Time
9, Registrant
Requi rement
|
Reports
Pattern
Substance
Frame
Response
Munber
L
1
2
3
Prod Chea - Regular Ghcwical
61-1
Product identity t compositionCl)
ABCDEFGHIJ KLMN O
MF/1P
1 BOS.
61-2(a)
Oescrip of starting n*»tefialsr(1»<>5
ABCDEfSHIJRLtlNO
MP/EP T'-;
Ef ¦'iqjpl'f
production & formulation
proc
61-2(b)
Discussion of formation of (1,3)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
impurities
62-1
Preliminary analysis (1,4)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
62-2
Certification of limits;" <1,5)
ABCD1FGHIJKLMNO
HP/EP
r
62-3
Analytical method (1)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-2
Color
ABCDEFGHIJKLMNO
MP/EP
8
63-3
Physical state
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-4
Odor .
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-7
Density
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-12
pH (9)
ABCDEF6HIJiffiBfG
MP/EP
8 mos.
63-14
Qxidlling or reducing action (10)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
10. Certification
11. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete,
t acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12, Name of Company Contact
13. Phone Number
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address
MONSANTO CO.
700 14TH STREET,
N.W. SUITE 1100
WASHINGTON DC 20005
2. Case # and Name
4099 Zinc salts
EPA Reg, No. 524-354
5. Date and Type of DC1
PRODUCT SPECIFIC
ID# 524-RD-2377
4. Guideline
Requi rement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
63-15
63-16
63-17"
63-18
63-19
63-20
63-21
Flimnabillty
Explodability
Storage Stability ''
Viscosity
Hiscibility
Corrosion characteristics
Dielectric breakdown voltage
Acute Tmtie ^ Regular Ctwical
(11)
(12)
(13)
(14)
£15)
81-
81-
81-3
81-4
81-5
81-6
Atyte oral toxicity-rat (1,36,37)
Acute dermal (1,2,37)
toxic! ty-rabbi t/rat
Acute inhalation toxicity-rat (3)
Primary eye ii-fiitBtfon-rabbit (2)
Primary dermal irritation <1,2)
Dermal Mnsltfiatftri (4)
ABCDEFGHIJKLMNO
ABCDE FGHIJKLMNO
ASCDEFGHUKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKJJlifO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/1P
MP/EP
MP/EP
MP/EP
EP ?"¦
MP/EP
MP/EP
MP/EP
MP/IP
8 mos.
8 won I
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
,8::|i0i*
Initial to indicate certification as to information on this paf«
(full text of certification Is on page one).
Date
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Key: HP = manufacturing-use product; EP = end-use product; provided formula tors purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product. [NOTE: If a product is a 100 percent repackage of another registered proAtct that is purchased, and any use for the product does
not differ front those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TGAI = technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop t - Greenhouse nonfood crop J - forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two <5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Che* - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and composition (61-1); *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process Mill suffice if the pesticide is not already under full scale prockiction and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shell be submitted to
the extent this information is available.
4 Required to support the registration of each manufacturing-use product (including registered TGAIs) as well as end-use products produced by an integrated system.
Data on other end-use products will be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test substances are dispersibte with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Clinical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category 1 on the basis
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of use will result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is required for organophospates, and may be required for other cholinesterase inhibitors and other pesticides
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 2 0460
FOOTNOTES AMD KEY DEPUTATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Footnotes (cont.):
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with th# agency for development of protocols mil methodology
prior to initiation of studies.
37 Testing of the EP dilution is retired if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.170(b) or the criteria for initiation of special review specified in 40 CFR 154.7 (a}(1).
-------
Page 1 of 2
United states Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested cm this form.
Use additional sheet(s) If necessary.
1. Company name and Addr«sg
CHAS H. LILLY CO.
7737 N. IJ. K1LLINGSWORTH
PORTLAND OR 97218
2. Case § and Name
4099 iinc salts
EPA Reg. No. 802-508
, Bate and Type of DEI
PRODUCT SPECIFIC
ID# 802-RD-2341
4, Guideline
Requirement
Number
5. Study Title
Progress
Reports
6, Use
Pattern
7. Test
Substance
8. Time
Frame
9. Resistrant
Response
61-1
61-2(a)
61-2(b)
-1
-2
¦3
62-
62-
62-
63-2
63-3
63-4
63-7
63-12
63-14
Prod Chew - tegular Ctwicul
Product identity I CMposftlon(t)
Descrip of starting materials,(t,2)
production & formulation
• proc
Discussion of formation of (1,3)
impurities .
Preliminary analysis (1,4)
Certification df limits (1,5)
Analytical method (1)
Color
Physical state
Odor
Density
pH (9) J
Oxidizing or reducing action (10)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/EP
MP/EP
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKIMNO
MP/EP
ABCDEFGHIJKLMNO
ABCDEFGHIJKMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 SOS .
8 mos.
S mos.
8 mos.
8 mos.
8 mos.
10. Certification
I certify that the statements made on this form and alt attachments are true, accurate, and complete,
t acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable Ian.
Signature and Title of Company's Authorized Representative
12. Man* of Company Contact
11. Date
13. Phone Number
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
0MB Mo. 2070-0107
Approval Expires 12-31-9i:
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information revested on this form.
Use additional sheet(s) if necessary.
1. Coirpany name and Address
CHAS H. LILLY CO.
7737 N.E. KILLINGSWORTH
PORTLAND OR 97218
4. Guideline
Requi rement
Number
2. Case if and Name
4099 Zinc salts
EPA Reg. No. 802-508
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
3. Date and Type of DC!
PRODUCT SPECIFIC
ID# 802-RD-2341
8. Time
Frame
9. Registrant
Response
63-15
63-16
63-17
63-18
63-19
63-20
63-21
81-1
81-2
81-3
81-4
81-5
81-6
FlammabUity (11)
Explodability (12)
Storage stability
Viscosity (13)
Niscibility (14)
Corrosion characteristics
Dielectric breakdown voltage: (15)
Acuta Toxic - Regular Chfical
Acute oral toxicity-rat (1,36,37)
Acute dermal (1,2,37)
toxictty-rebbi t/rat
Acute inhalation toxicity-rat (3)
Primary eye irri tatipnrrahbit: (2)
Primary dermal irritation (1,2)
Dermal sensitization (4)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDE FGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDE FGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
EP
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDE FGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
8
8
8
8
8
8
8
flips,
mos.
mos.
mos.
mos.
mos.
mos.
8 mos.
8 mos,
8 mos,
8 mos
8 mos
a mos
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Date
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Key: MP = manufacturirifl-use product; IP = end-use product; provided femulators purchase their active ingredlent(s) from a registered source, they need not submit or cite
data pertaini r>g to the purchased product. MOTE; If a product Is a 100 percent repackage of another registered product that is purchased, and any use for the prockct does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TIP = typical end-use product!
TGAt = technical grade of the active ingredient; PA1 = "pure" active ingredient; PAIR* = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
f - Aquatic nonfood Industrial C - Aquatic nonfood residential K - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in cotimn two (5. Study Title} of the REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE form.}
Prod Chew - Regular Chemical
1 Requirements pertaining to product identity, cempMition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and cotrposition {61-1); *158,160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); *158,16? for
discussion of formation of impurities (61-3); *118.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production and an experii&ental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 Required to support the registration of each manufacturing-use product (including registered TGAIs) as welt as end-use products produced by an integrated system.
Data on other end-use products will be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an enrulsifiable liquid and is to be diluted with petroleun solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Chemical
1 Not retired if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product wilt be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the prodiet consists of, or under conditions of use nil! result in, an inhalable material (e. g., gas, volatile substances, or aerosol /particulate).
4 Required in I ess repeated dermal exposure does not occur under conditions of use,
36 Special testing (acute, subehronie, and/or chronic) is required for organophospates, and may be required for other chol inesterase inhibitors and other pesticides
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. c. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Nane: 4099 Zinc salts
Footnotes (cont. ) :
which have demonstrated a potential to adversely affect the visual system. Resist rants should consult with the agency for development of protocols and methodology
prior to initiation of studies.
3? Testing of the EP dilution Is required if it can be reasonably anticipated that the results of such testing May meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.170(b) or the criteria for initiation of special review specified in 40 CfR 154,7 (a)(1).
-------
Page 1 of 2
United States
Environmental
Protection Agency
Form Approved
Washington,
D. C. 20460
0MB No. 2070-010?
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached Instructions and supply the information requested on this form.
Use additional sheet(i)
t f necessary.
1, Company name and iddres*
2.
Case # and name
3. Date and Type of DCJ
CHAS H. LILLY CO.
4099
Zinc
salts
PRODUCT SPECIFIC
7737 N.E. KILLINGS WORTH
ID# 802-RD—2342
PORTLAND OR
97218
EPA Reg.
NO. 802-553
4. Guideline
5. Study Title
r
R
Progress
6, Use
7. Test
8. Time
9. Registrant
Requi rement
Reports
Pattern
Substance
Frame
Response
Number
L
1
2
3
Prod Chea - Reoular Cheatcal
61-1
Product identity i eemposftionO)
ABCDE FGHIJKLMNO
MP/EP
8 mos.
61-2(a)
Descrip of starting materials,(1,2)
ABC0EFGHIJKUWO
MP/EP
8 mos.
production & formulation
proc
61-2(b)
Discussion of formation of
(1,3)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
impurities.
62-1
Preliminary analysis
(1,4)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
62-2
Certification of limits
(1,5)
ABCDEFGHIJKUfNO
MP/EP
8 mos.
62-3
Analytical method
(1)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-2
:¦ Color
ABCDEFGHIJKUfflre
MP/EP
8 mos.
63-3
Physical state
ABCDIFGHIJKLMNO
MP/EP
8 mos.
63-4
Odor
ABCDIFGHIJKLMMQ
MP/EP
8 mos.
63-7
Density
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-12 :'V'
P« .
i: na
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-14
Oxid!2ing or reducing action (10)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
10. Certification
11.
Date
I certify that the statements made on this form and all attachments are true.
accurate.
and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable
law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
IS.
Phone Nuitier
-------
Page 2 of 2
United States Environmental Protection Agency-
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS; Pleas* type or print in ink. Please read carefulty the attached instructions and supply the information requested on thia form.
Use additional sheet(s) if necessary.
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
1. Company name and Address
CHAS H. LILLY CO.
7737 N.E. KILLINGSWORTH
PORTLAND *OR 97218
Case # and Nome
4099 Zinc salts
EPA Reg. No. 802-553
3. Date and Type of DC1
PRODUCT SPECIFIC
ID# 802-RD-2342
4. Guideline
Requi rement
Number
5. Study Title
Prepress
Reports
6. Use
Pattern
7. Test
Substance
8, Tin
Frame
9. Registrant
Response
'63-15
63-16
.63-1?
63-18
63-19
63-20
63-21
81-
81-
81-3
81-4
81-5
81-6
Flanrabi I i ty : £ 1 <11)
Explodability (12J
Storat*-stabiMt'jf'
Viscosity (13)
Niscibitity (14)
Corrosion characteristics
Dielectric br«6ikiioi(rt voltage (15)
Acut#' Tflkicl""-: Rewlir Chficol ^
' '¦ Acute or® i . tax i ci ty? tja* ;:;:i " (1 37)
Acute dermal (1,2,37)
toxicity-rabbit/rat "
Acute inhalation toxicity-rat (3)
Primary eye irritation-rabbit (2)
Primary dermal irritation (1,2)
Dermalii'lton ' (4)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFCTI^IOEIINO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDBIGBIJKlJiNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
EP
MP/EP
MP/EP
MP/EP
HP/EP
MP/EP
MP/EP
8 mos.
81 mos.
8 mos.
8 mos.
8 mos.
8 AOS.
8 mos.
8 mos
8 mos
8 mos.
8 lies-;
Initial to indicate certification as to information on this page
(fylt text of certification is on page ana).
Date
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Key: HP = rmnufacturing-use product; EP * end-use product; provided femulators purchase their active ingredient(«) from a registered source, they need riot siimft or cite
data pertaining to the purchased product. [NOTE: If a product is a 100 percent repackage of another registered prwfciet that is purchased, and any use for the prockict does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.I; TIP » typical end-use procfcxt;
TGAI = technical grade of the active ingredient; PA I ¦ "pure" active ingredient; PAIR* = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F * Aquatic nonfood Industrial 6 - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - indoor food M - Indoor nonfood N - Indoor Medical 0 * Indoor residential
Footnotes: [The following notes are referenced in column two <5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod CMs» - Regular Cheni cat
1 Retirements pertaining to product identity, composition, analysis, and certification of ingredients ere detailed further in the following sections; *158.151 for
product identity and composition (41-1); *158.160, 158.162, and 158.165 for description of starting materials and manufaeturing process C61-2); *158.16? for
discussion of format ion of impurities <61-3); *118.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be siixnitted to
the extent this information is available,
4 Required to support the registration of each manufacturing-use product (including registered TCAIs) as well as end-use products produced by an integrated system.
Data on other end-use proAicts Mill be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test sutatanees are dlspersible with water,
10 Required if product contains an ©xidiiing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
K Required if product is an emulsifiable liquid ard is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Choaical
1 Not required if test material is a gas or highly volatile.
2 Not retired if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of use will result in, an inhalable material (e. g», gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of un,
36 Special testing (acute, subchronlc, and/or chronic) is required for organophospates, and may be required for other eholinesterase inhibitors and other pesticides
-------
Page 2 of 2
United states Environmental Protection Agency
Washington, D. C- 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 line salts
Footnotes (cont.):
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to initiation of studies.
37 Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing nay meet the criteria for restriction to use by certified
applicators specified ir» 40 CFR 152.170(b) or the criteria for initiation of tpeeial review specified in 40 CFR 154.7 (aKI).
-------
Page 1 of 2
United states Environmental Protection Agency
Washington, D, C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) If necessary.
1. Company name and Address
CHAS H. LILLY CO.
7737 N.E. KILLINGSWORTH
PORTLAND OR 97218
Case # and Name
4099 Zinc salts
EPA Reg. No. 802-591
3. Date and Type of DC!
PRODUCT SPECIFIC
ID# 802-RD-2375
4. Guideline
5. Study Titte
T-
R
Q
Progress
6. Use
7. Test
8. Time
9. Registrant
Requi rement
I
Reports
Pattern
Substance
Frame
Response
Number
8
L
1
2
3
Prod Chea - Xenular Cheaieal
61-1
Product identity & composttion<1)
ABODEFGHIJKIMNO
MP/EP
8
mos.
61-2(a)
ttescrlp of startiris :
ABCDEFGHIJKLMNO
. 8
mos.
production & formulation
proc'
61-2(b)
Discussion of formation of
(1,3)
ABCDEFGHIJKLMNO
MP/EP
. 8
mos.
impurities
62-1
Preliminary analysis
<1,4)
ABCDEFGHIJKMNO
MP/EP
8
mos.
62-2
Certification of limits
<1,5)
ABCMFGHIJKIMtld
MP/EP ill
mos.
62-3
Analytical method
<1)
ABCDEFGHIJKUfNO
MP/EP
8
mos.
63-2 :
Color
AKMiwiJioiiMfi
MP/EP
8
mos.
63-3
Physical state
ABCDEFGHIJKUINQ
MP/EP
8
mos.
63-4 •
Odor
ABC D1FGHIJ KIMNO
MP/EP
8
BOS.
63-7
Density
ABCDEFGHIJKIMNO
MP/EP
8
mos.
63-12
PK ;
:&w
ABCDEFGHIJK1MNO
MP/EP
8
mos*
63-14
Oxidizing or reducing action
(10)
ABCDEFGHIJKMNO
MP/EP
8
mos.
10. Certification
11. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete,
t acknowledge thBt any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
13. Phone Nuifaer
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in Ink. PIesse read carefully the attached instructions and supply the Information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address
CHAS H. LILLY CO.
7737 N.E. KILLINGSWORTH
PORTLAND OR 97218
3, Case # and Name
4099 Zinc salts
EPA Reg. No. 802-591
3. Date and Type of DC1
PRODUCT SPECIFIC
ID# 802-RD-2375
4. Cuideline
Requi rement
Nunber
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
63-15
63-16
63-17.
63-18
63-19
63-20
63-21
81-
81-
81-3
81-4
81-5
81-6
Flantnabi I ity til)
Explodability (12)
Storage stability
Viscosity (13)
Kiseibility (14)
Corrosion characteristics
Dielectric braikctewrt Voltage (15)
toite Twdc - Regular Clerical ,
Acute oPal' toxicity-rat s/j; -if
Acute dermal (1,2,37)
toxicity-rabbit/ftst :
Acute inhalation toxicity-rat (3)
Primary eye irritation-rabbit (2)
Primary dermal irritation (1,2)
Dermal iewitfiatllri1: '• (4)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEiGHltlOSMNO
ABGDEFGHIJKtilfflld
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIjKLMNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
:.a:i
8
8
8
mos.
nos.
mos.
mos.
mos.
mos.
mos.
nos.
mos.
8 mos.
8 mos.
8 mos.
Initial to indicate certification as to information on this page
(full text of certification is on pege one).
Date
-------
Page I of 2
United states Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Naae: 4099 Zinc salts
Key; MP = manufacturing-use product; EP = end-use product; provided! formula tors purchase their active ingredient(s) from ¦ registered source, they need not submit or cite
data pertaining to the purchased product, [MOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TIP = typical end-use product;
TCAI = technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop t - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in colum two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE fori.]
Prod Choi - Regular Chemical
1 Requirements pertaining to product identity, conposition, analysis, and certification of ingredients are detailed further in the following auctions; *158.155 for
product identity and composition C61-1); *158.16#, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of impurities C61-3); *158.170 for preliminary analysis C6Z-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the protection process will suffice if the pesticide it not already tinder full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale prockjction and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 Required to support the registration of each manufacturing-use proAict (including registered TGAls) as well as end-use products produced by an integrated system.
Data on other end-use proebcts will be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if teat substances are dispersible uith Hater.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains conixistible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an etnulsifiable liquid and is to be diluted with petroled* solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Chemical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of use will result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, arid/or chronic) is required for organephospates, and may be required for other cholinesterase inhibitors and other pesticides
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AMD KEY DEFIMATIONS FOR GOIDEUHE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Footnotes (confc.):
which have demonstrated a potential to adversely affect th# visuaL tysta*. Registrants should consult with the afency for development of protocols are! methodology
prior to initiation of studies.
37 Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing i*Y the criteria for restriction to use by certified
appl icators specified in 40 CF8 152.170(b) or the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
0MB No. 2070*0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Conpany name and Address
BAXTER J H & COMPANY
1700 S EL CAMINO REAL
SAN MATEO CA 94402
2. Case # and Name
4099 Zinc salts
EPA Reg, No. 3098-18
5. Date and Type of DCI
PRODUCT SPECIFIC
ID# 3098-RD-2378
4, Guideline
Requi rement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7, Test
Substance
B. Time
Frame
9. Registrant
Response
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2.
63-3
63-4 w
63-7
63-1#'
63-14
Prod Chew - Regular Chewicnl
Product identity t composition 1)
Descrip of starting iMiriSli,iH,21
production & formulation
••• •: proc
Discussion of formation of (1,3)
iipuHties v,
Preliminary analysis (1,4)
Cert if icatiofi'if {1,5)
Analytical method C1>
Color
Physical state
Odor
Density
pH (9>
Oxidiiing or reducing action CIO)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDIFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDIFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
kp/e£;
MP/EP
MP/EP
MP/EP
MP/EP
MP/IP
8
8
mos.
nos,
8 mos,
8
8
8
8
8
8
8
8
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
10. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company Contact
13. Phone Nmiier
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
OHB Mo. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Pleas* read carefully the attached instructions and supply the information requested Oft this form.
Use additional sheetCs) if necessary.
1. Company mmm and Address
BAXTER J H & COMPANY
1700 S EL CAMINO REAL
SAN MATEO CA 94402
2. Case # and None
4099 Zinc salts
EPA Reg. No. 3098-18
, Date and Type of DC1
PRODUCT SPECIFIC
ID# 3098-RD-2378
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Tin
Fra»e
9, Registrant
Response
63-OT
63-16
63-17
63-18
63-19
63-20
63-21
81-1
81-2
81-3
81-4
81-5
81-6
' F tsftmabi I < t y
Exptodability
, Storage staMlitf
Viscosity
Miscibility
Corrosion characteristics
: Dielectric breakdown-volt age
Acute Toxic - Regular Ctwical
{in
(12)
C13)
CHI
dsp
Acute oral toxfcity-ret C 1,34,37)
Acute dermal <1,2,37)
toxi elty-rabbitf/Kit:;::;:j •
Acute inhalation toxicity-rat (J)
Primary eye irritation-rabbit (2)
Primary dermal irritation (1,2)
Dermal sensitization (4>
ABCDEFGHiJKLKIiO
ABCDEFCTIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
'ABCDIFGKIlTKiliNO:
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
abcdefghijkiMo
ABGDEltmiJlLMNO
MP/EP
MP/EP
MP/EP
MP/EP
EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
Initial to indicate certification as to information en this page
Cfull text of certification is on page one).
Date
8
8
BIOS,
mos.
:
mos.
mos.
mos.
woe.
mos.
8 mos.
8 mos.
8 BIOS.
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Key: MP * manufacturing-use product; EP * end-use product; provided formulators purchase their active ingredient(8) from a registered source, they need not submit or cite
data pertaining to the purchased product. [NOTE: If a product Is a 100 percent repackage of another registered product that is purchased, and any use for the prockict does
not differ from these of the purchased and registered source, users are not subject to any data requirements identified in the tobies.J; TEP = typical end-use proAJCt;
TGAI * technical grade of the active ingredient; PAI = "pure" active ingredient; PAIR* = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop 0 - Aquatic food crop I - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food N - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.!
Prod Cheat - Regular Chearical
1 Requirements pertaining to product identity, cof(position, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and composition (61-1); *158,160, 158,142, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of impurities (61-3); #158.170 for preliminary analysis C62-1); *158.175 for certification of limits <62-2); arid *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the protection process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale protection and an experimental use permit is sought, a discussion of unintentional ingredients shall be siisnitted to
the extent this information is available.
4 Require*! to seaport the registration of each manufacturing-use product (including registered TGAIs) as well as end-use products produced by an Integrated system.
Data on other end-use proAicts will be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
Mill suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use,
9 Required if test substances are dispersible with water,
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an emulsiffable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular CheNical
1 Not required If test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of usr will result In, an irihalable material (a. gas, volatile substances, or aerosol/partieulate).
4 Required unless repeated dermal exposure does not occur wider conditions of usa.
36 Special testing (acute, siixshronic, and/or chronic) is required for organophespates, and may be required for other cholincsterase inhibitors and other pesticides
-------
Page 2 of 2
United States Environmental Protection Agency-
Washington, D. C. 20460
FOOTNOTES AMD KEY DEFIMATIONS FOR GUIDEUHE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Footnotes (cont.):
which have demonstrated a potential to adversely affect the visual system, l«fl 1st rants should consult with the agency for development of protocols and methodology
prior to Initiation of studies,
37 Testing of the EP dilution is retired if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.170(b) or the criteria for initiation of special review specified in 40 CFt 154.7 (aHO-
-------
Page 1 of 2
United States Environmental
Protection Agency
Form Approved
Washington,
D. C
. 20460
0MB No. 2070-0107
REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE
Approval Expires 12-31-%
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet
-------
Page 2 of 2
United States Environmental
Protection Agency
Form Approved
Washington,
D. C. 20460
0MB Ho. 2070-0107
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the
attached instructions and supply ttie information requested
on this form.
Use additional sheet(s)
if necessary.
1. Company name and Address
2.
Case # and Name
3. Date and Type of OCI
WESPAC ENTERPRISES INC
4099
Zinc
salts
PRODUCT SPECIFIC
2415 S 2 0 0TH
ST BOX 4 6337
ID# 5550 0—RD
-2380
SEATTLE WA 98146
EPA Reg.
No. 55500-1
U. Guideline
5. Study Title
R
0
Progress
6. Use
7. Test
8. Time
9. Registrant
Requirement
T
0
Reports
Pattern
Substance
Frame
Response
Number
C
0
L
1
2
3
63-15
F Istnnabi I i ty (11)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-16
Explodabi I ity (12)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-17
Storage stabi I i ty
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-18
Viscosity (13)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-19
Miscibility (K)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-20
Corrosion characteristics
ABCDEFGHIJKLMNO
MP/EP
8 mos.
63-21
Dielectric breakdown voltage (15)
ABCDEFGHIJKLMNO
EP
8 mos.
Acute Toxic - Regular Chetnicsl
81-1
Acute oral toxicity-rat (1,36,37)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
81-2
Acute dermal (1,3,37)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
toxicity-rabbi t/rat
81-3
Acute inhalation toxicity-rat (3)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
81-4
Primary eye irritation-rabbit (2)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
81-5
Pr imary dermal irritation (1,2)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
81-6
Dermal sensitization (4)
ABCDEFGHIJKLMNO
MP/EP
8 mos.
Initial to indicate certification as to information on this page
Date
(full text of certification is on page one).
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
INSTRUCT IONS: Please type or print in Ink. Please read careful ly the attached instruct!or* and supply the information requested on thf* for*.
Use additional sheet (s) if necessary.
1. Conpany name and Address
CANADIAN ROOFING PRODUCTS
5555 SALISH RD
BLAINE WA 98250
2. Case i and Name
4099 Zinc salts
EPA Reg, No. 58494-1
3. Date and Type of DC1
PRODUCT SPECIFIC
ID# 58494—RD-2381
4. Guideline
Requi rement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Tin
Frame
9. Res I st rant
Response
61-
61-
1
2 (a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4:::::;
63-7
63-12
63-14
Prod Chew - Regular Chemical
Product identity £ conf*»«itionC1)
Peter
production & formulation
proc
Discussion of formation of (1,3)
inpurities
Preliminary analysis <1,4)
p Ctiiififeation of limits (1,5)
Analytical method CI)
:: Color
Physical state
Odor
Density
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
Oxidizing or reducing action
(io>
ABCDEFGHIJKIJINO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
iBCDEFGHiiiiiiiiJi
ABCDlliHijKLMNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MSpP
MP/EP
8 DOS.
8 BOS.
8 DOS.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 SOS.
10. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete,
I acknowledge that any knowingly false or misleading statement my be punishable by fine, inprisorment
or both under applicable taw.
Signature and Title of Company's Authorized Representative
11. Date
12. dame of Company Contact
13. Phone Matier
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
0MB No. 2070-0107
Approval Expires 12-31-92
IHSTRUCTIOMS: Please type or print in ink. Pleas* read carefully the attached instructions arid supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Conpany name and Address
CANADIAN ROOFING PRODUCTS
5555 SALISH RD
BLAINE WA 98250
2. Case # and Name
4099 Zinc salts
EPA Reg. No. 58494-1
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 58494-RD—2381
4. Guideline
Requirement
Number
5. Study Title
Progress
Report#
A, Use
Pattern
7. Test
Substance
8, Time
Frame
9. Registrant
Response
<53-15
63-16
63*17*
63-18
63-19
63-20
'63*21^'
81-1
81-2
81-3
81-4 s
81-5"
f lamnabi I i ty
Explodsbili ty
'¦ stab! lity
Viscosity
. MiscfbUity ¦:
Corrosion characteristics
^¦DitttdtH'ics breakdown voI tag#
(12)
(13)
(14)
(15)
ABCDIFGHIJKLMNO
ABCimfGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
*
Acute dermal <1,2,37)
toxicity-rabbit/rat
Acute inhalation toxicity-rat (3)
Primary ey» Irritation-rabbit (2)
Primary dermal irritation (1,2)
Dermal sensitization (4>
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHUKIMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKIUNO
ABCDEFGHIJKLMNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
8 BIOS.
8 mos.
8 mos.
8 mos,
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Initial to indicate certification as to information on this page
{full text of certification is on page one).
Date
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 2 0460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Key: HP = Manufacturing-use product; EP = end-use product; provided formula tors purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP ¦ typical end-use product;
TGAI = technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled,
llse Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J * Forestry
(C - Residential outdoor I - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Chea - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and composition (61-1); *158.160, 158.162, and 158.165 for description of starting Materials and manufacturing process (61-2); *158.167 for
discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale procfcxtion and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 Required to si^jport the registration of each manufacturing-use product (including registered TGAls) as well as end-use products produced by an integrated system.
Data on other end-use proAicts will be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
will suffice to seaport an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidiiing or reducing agent.
11 Required if product contains combustible liquids,
12 Required if prodlict is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an emulsifiable liquid and is to be diluted with petroleun soLvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Chemical
1 Not required if test material is a gas or highLy volatile.
2 Not required if test material is corrosive to skin or has pH Less than 2 or greater than 11.5; such a product Hill be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the procfcict consists of, or under conditions of use will result in, an InhaLable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is required for organophospates, and may be required for other cholinesterase inhibitors and other pesticides
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C, 20460
FOOTNOTES AND KEY DEFIMATIONS FOE GUIDELINE REQUIREMENTS
Case f and Naae: 4099 Zinc salts
Footnotes (cont.):
which hove demonstrated a potential to adversely affect the visual system. Registrants should consult with the afeney for development of protocols and methodology
prior to initiation of studies,
3? Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing may me«t the criteria for restriction to uh by certified
applicators specified in W CFR l52.170Cb) or the criteria for initiation of special revie* specified in 40 CFR 154,7
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
0MB Ho. 2070 0107
Approval Expires 12-31-92
INSTRUCTIONS: Pleas# type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet!8) if necessary.
1. Company name and Address
DAVID A. WALTZ IMPORTS
D/B/A MENZIES SHEET METAL
13903 S.E. 14TH ST
VANCOUVER WA 98684
2. Case # and Name
4099 Zinc salts
EPA Reg. No. 58509-1
3. Date and Type of DC)
PRODUCT SPECIFIC
ID# 58509-RD-2382
4. Guideline
Requirement
Nunber
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Tim
Frame
9. Registrant
Response
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-7
63-12
63-14
Prod Ctien - Regular chemical
Product identity & composition(l)
DescHp of starting materials,(1,2)
production & formulation
proc
Discussion of formation of (1,3)
inpuri ties
Preliminary analysts (1,4)
Certification of limits (1,5)
Analytical method (1)
Color
Physical state
Odor
Densi ty
pH (9)
Oxidizing or reducing action (10)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKIMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJK1MNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
8 itios,
8 DOS,
8 los.
8 mos.
8 mos.
8 jii O s«
8 mos.
8,mos,
8 mos.
8 mos.
8 mos.
8 mos.
10. Certification
I certify that the statements made on this form and all attachments are true, iceurate, and complete.
1 acknowledge that any knowingly false or mis leading statement may be punishable by fine, i imprisonment
or both under applicable Ian.
Signature and Title of Conoany's Authorized Representative
11. Date
12. Name of Ccwpany Contact
15. Phone Nufnber
-------
United States Environmental Protection Agency
¦Washington, D. C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
Page 2 of 2
Form Approved
0MB No. 2070-0107
Approval fjspires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions end supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address
DAVID A. WALTZ IMPORTS
D/B/A MEN ZI IS SHEET METAL
13903 S.E. 14TH ST
VANCOUVER WA 98684
Case # and Name
4099 Zinc salts
EPA Reg, No. 58509-1
3. Date and Type of DC I
PRODUCT SPECIFIC
ID# 58509-RP-2382
4. Guideline
Requirement
Nunber
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
63-15
63-16
63-17
63-18
63-19
63-20
63-21
81-1
81-2
81-3
81-4
81-5
81-6
em
(12)
f lammabiIi ty
Explodability
Storage stability
Viscosity
Kiscibility
Corrosion characteristics
Dielectric breakdown voltage (15)
(13)
(14)
Heme Twig - Regular Oaiiwl
Acute oral toxicity-rut <1,36,37)
Acute dermal (1,2,37)
toxicity-rabbit/rat
Acute inhalation toxicity-rat (3)
Primary mym irritation-rabbit (2)
Primary derail irritation (1,2)
Dermal sensitization (4)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKUWO
ABCDEFGHIJKIMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKIMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/1P
MP/EP
MP/EP
MP/EP
MP/EP
EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
8 mos.
8 mos,
8 mos.
8 mos.
8 mos,
8 mos.
8 mps.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Date
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Keys HP * manufacturing-use product; EP « end-use product; provided fermulawrs purchase their active IngredlentCs) from a regfatered source, they used not * limit or cite
data pertaining to the purchased product.[NOTEs If a product is • 100 percent repackage of another registered product that is purchased, sod any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP » typical end-i»e product;
TGAI = technical, grade of the active ingredient; PAl * "pure" active ingredient; PAIR* = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop 8 - Terrestrial food feed crop C - Terrestrial nonfood crop D ¦ Aquatic food crop I - Aquatic nonfood outdoor
F « Aquatic nonfood Industrial 0 - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J ¦ Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced fn column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.l
Prod Chen • Regular Cheaical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detaited further in the following sections; *158.155 for
product identity and conposition (61-1); *158.160, 158.162, end 156.165 for description of starting materials and manufacturing process (61-2); *150.167 for
discussion of formation of injjurities (61*3); *158.170 for preliminary analysis (62-1); *158.175 for certification of timits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit ii being sought.
3 If the pesticide is riot already under full scale production and an experimental use permit is sought, • discussion of unintentional Ingredients shall be submitted to
the extent this information Is available.
U Required to support the registration of each manufacturing-use product (including registered TGAls) as well as end-use products produced by an integrated system.
Data on other end-use products Hill be required on a case-by-case basis, for pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
? Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an emutsi f ioble liquid and is to be diluted with petroleun solvents.
15 Required if end-use product Is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Oieaical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified at Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of use Mill result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is requi.ed for organophospates, and may be required for other chotinesterase inhibitors and other pesticides
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFIHATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Footnotes (cant.):
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to initiation of studies.
3?" Testing of the IP dilution is required if it can be reasonably anticipated that the results of such testing my meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.170{b) or the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).
-------
. • Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions acid supply the information requested on this form.
Use additional sheetCs) if necessary.
Fern Approved
0MB Mo. 2070-010?
Approval Expires 12-31-92
1. Company name and Address
RETTA MFG., INC.
BOX 2306
EUGENE OR 97402
2, Case § and Name
4099 Zinc salts
EPA Reg. No. 10699-1
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 10699-RD-2376
4. Guideline
ftequi rement
Wurrtoer
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Tine
Fr
9, Registrant
Response
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-7
63-12
63-14
Prod Chew - R«*gular Chemical
Product identity & composition(l)
Descrip of starting materials,(1,2)
production & formulation
proc
Discussion of formation of (1,3)
inpurfties
Preliminary analysis (1,4)
Certification of limits <1,5)
Analytical method <1)
Color
Physical state
Odor
Density
P« (9)
Oxidizing or reducing action (10)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/EP
MP/IP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
8 mos,
3 nos.
8 nos,
3 inos.
8 BOS.
8 BIOS.
8 sos ¦
8 nos.
8 mos.
8 raos.
8 mos.
8 mos.
10. Certification
J certify that the statements made on this form and all attachments are true, accurate, and complete,
t acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
11. Date
12. tame of Company Contact
13. Phone Ntmber
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
Form Approved
0M8 No, 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink.
Use additional sheet(s) if necessary.
Please read carefully the attached instructions and supply the information requested on this form.
1. Company name and Address
RETTA MFG. , INC.
2306
OR 97402
2. Case # and Name
4099 Zinc salts
EPA Reg. No. 10699-1
3. Date and Type of OCI
PRODUCT SPECIFIC
ID# 10699-RD-2376
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. time
Frame
9. Registrant
Response
63-15
63-16
63-17
63-18
63-19
63-20
63-21
81-1
81-2
81-3
81-4
81-5
81-6
Flanraability {11}
Explodabi 1 ity (12)
Storage stabi I i ty
Viscosity (13)
Mi sctbili • y {14)
Corrosion characteristics
dielectric breakdown voltage (15)
Acute Toxic - Regular dwical
Acute oral toxicity-rat <1,36,37)
Acute dermal (1,2,37)
tox i c i ty- r abb i t / rat
Acute inhalation toxicity-rat (3)
Primary eye irri tat ion-rabbit (2)
Primary dermal irritation (1,2)
Hernial sensitization (4)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNQ
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
IP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
8 BIOS.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 BIOS.
8 mos.
8 mos.
•
8 mos.
8 mos .
8 mos.
8 mos,
Initial to indicate certification as to information on this pege
(full text of certification is on page one).
Date
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4099 Zinc salts
Key: HP = manufacturing-use product; EP = end-use product; provided formula tors purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product. [NOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TGAI - technical grade of the active ingredient; PA I = "pure" active ingredient; PAIR* = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop 0 - Aquatic food crop E - Aquatic nonfood outdoor
f - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food H - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in cotwm two (5. Study Title) of the REQUIREMENTS STATUS ANO REGISTRANT'S RESPONSE form.]
Prod CheM - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and conposition (61-1); *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 Required to support the registration of each manufacturing-use product (including registered TGAIs) as well as end-use products produced by an integrated system.
Data on other end-use products will be required on a case-by-case basis, for pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains confcustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Chemical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or.has pH les- than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of use will result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is required for organoptiospates, and may be required for other cholinesterBSe inhibitors and other pesticides
-------
Page 2 of .2
United states Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AMD KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Naite: 4099 Zinc salts
Footnotes (confc.J:
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to initiation of studies,
37 Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing way meet the criteria for restriction to use by certified
applicators specified in 40 CFR 15Z.1?0(b) or the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20440
JUL 2 91986
PR NOTICE 86-5
NOTICE TO PRODUCERS, FORKULATORS, DISTRIBUTORS
' AND REGISTRANTS
Attention: Persona responsible for Federal registration of
pesticides.
Subject: standard format for data submitted under the Federal
Insecticide# Fungicide, and Rodenticide Act (FIFRA)
and certain provisions of the Federal Food, Drug,
and Cosmetic Act (FFDCA),
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This notice also
provides additional guidance about, and illustrations of, the
required formats,
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining pesticide
registrations, experimental use permits, tolerances, and related
approvals under certain provisions of FIF1A and FFDCA. These
data are defined in FIFRA S10(d)C1). This Notice does not apply
to commercial, financial, or production information, which are,
and must continue to be, submitted differently under separate
cover.
III. Effective Pate
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the submitter
for necessary revision,
IV. Background
On September 26, 1914, EPA published proposed regulations
in the federal Register (49 PR 37956) which include Requirements
for Data Submission (40 CPR $158.32), and Procedures for Claima
of Confidentiality of Data (40 CFR 1158,33). These regulations
(Sz)
4i mail
l
-------
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must_be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confident iality'are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final, Adequate lead time is
being provided for submitters to comply with the new requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address
the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how
the study objectives, protocol, observations, findings, and
conclusions are organized and presented within the study report.
The data reporting guidance will be compatible with submittal
format requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA S3. The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages* As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein,
OPP has also established a public docket which imposes dead-
lines for inserting into the docket documents submitted in con-
nection with Special Reviews and Registration Standards (see
40 CPR §154.15 and J1SS.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this requirement.
for several years, Off has required that each application for
registration or other aetion include a list of all applicable
data requirements and an indication of how each is satisfied—the
statement of the method of support for the application. Typically,
many requirements art satisfied by reference to data previously
submitted—either by the applicant or by another party. That re-
quirement is not altered by this notice, which applies only to
data submitted with an application.
VI. format Requirements
A more detailed discussion of these format requirements
follows the index on the next page, and samples of aome of the
requirements are attached. Except for the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered# these samples
are illustrative. As long as the required information is included
and clearly identifiable, the form of the samples may be altered
to reflect the submitter's preference.
2
-------
- INDEX -
Text Example
Page Page
A. organization of the Submittal Package 3 17
B. Transmittal Document 4 n
C. Individual Studies .... ........ 4
C.l Special Considerations for Identifying Studies, . 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
D.2 Statement of Data Confidentiality Claims
(based on FIFRA S10(d)(1)) ........... a 13
D.3 Confidential Attachment 8 15
D.4 Supplemental statement of Data Confidentiality
Claims tother than those based on FIFRA flOCdHDl 8 14
D.5 Good Laboratory Practice Compliance Statement . . § 16
E. Reference to Previously Submitted Data ....... 9
F. Physical Format Requirements « number of Copies ... 9
G. Special Requirements for Submitting Data to the Docket 10
**************
A. Organization of Submittal Package
A 'submittal package' consists of all studies submitted at
the same time Cor review in support of a single regulatory action,
along with a transmittal document and other related administrative
material (e.g. the method o£ support statement, EPA Forms 8S70-1,
8570-4# 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Bach study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasise, or otherwise comment to help
product Managers end reviewers better understand the submittal.
- If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
-------
B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--i.e., a registration application,
petition, experimental use permit (EUP), S3(cH2)(Bf data call-in,
S6ta) (2) submittal, or a special review; the transmittal date?
and a list of all individual studies included in the package in
the order of their appearance, showing (usually by Guideline
reference number) the data requirements> addressed by each one.
The EPA-ass igned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be
included in the transmittal document as well, if it is known to
the submitter. See Attachment 1 for an example of an acceptable
transmittal document.
The list of Included studies in the transmittal of a data
submittal package supporting a registration application should
be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CF1 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C».... of the petition or application, as defined in 40 CFR
180.7 and 158. 125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
when a submittal package supports a tolerance petition and
an application for a registration or an EUP# list the petition
studies first, then the balance of the studies. Within these
two groups of studies follow the instructions above.
C. individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C«l. Bach study included in a submittal package
must be bound as a separate entity. (See comments on binding
studies on page 9.}
Each study must be consecutively paginated, beginning from
the title page as page I. The total number of pages in the com-
plete study must be shown on the study title pag«. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study
on each page (ie., 1 of 250, 2 of 250, ..«250 of 250).
- Include a company name or mark and study number on each
page of the study, e.g.. Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
4
-------
When a single study is extremely long, binding it in multiple
volumes is permissible so long as the entire study is paginated
in a single series, and each volume is plainly identified by the
study title and its position in the multi-volume sequence.
C.1 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 these cases each species
¦tested should be reported as a separate study, and bound
separately*
Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity testa, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study#
b. Product Chemistry Studies. All product' chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted In support of a techni-
cal product, other manufacturing-use product# an experimental
use permit, an import tolerance petition, or an end-use prod-
uct produced from unregistered source ingredients, should be
bound as a single study for each Guideline series (61, 62,
and 63) for conventional pesticides, or for the equivalent
subject range for biorational pesticides. The first of the
three studies in a complete product chemistry submittal for
a biochemical pesticide would cover Guidelines 151-10, 151-11,
and 151-12i the second would cover Guidelines 151-13, 151-15,
and 151-16; the third would cover Guideline 151-1?. The
first study lor a microbial pesticide would cover Guidelines
151-20, 151-21, end 151-22; the second would cover Guidelines
151-23 and 151-25* the third would cover Guideline 151*26.
Note particularly that product chemistry studies are
likely to contain Confidential Business information as defined
in FIFRA 510(d)(1)(A), (B), or (C), and if so must be handled
as described in section D.3. of this notice*
5
-------
c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a
level below that of the Guideline coda. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a
single study and bound separately for each analytical method,
each report of the nature of the residue in a single crop or
animal species, and for each report of the magnitude of resi-
dues resulting from treatment of a single crop or from proces-
sing a single crop. When more than one commodity is derived
from a single crop (such- as beet tops and beet roots) residue
data on all such commodities should be reported as a single
study, when multiple field trials are associated with a
single crop, all such trials should be reported as a single
study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed 'example1 cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Goo<1
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
When Required Example
Always Page 12
One of the two alternative Page 13
forma of this statement
is always required.
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain toxicology studies. (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If ClI is claimed under FIFRA
110(d)(&)» or (C)
If CBI is claimed under FIFRA Page IS
410(d)(1)(A),
-------
D. I Title Page
A title page is a 1 way s required for ^ ach subnifcfced study ,
published or unpublished, The title page mus t always be freely
re leasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable tii:le page is on page 12 of this
notice. The following information must appear on the title
pages
a. Study title. The study title should be as descriptive as
possible. It mjst clearly identify the subs tance{s) tested and
correspond to the name of the data requirement as it appears
in -the Guidelines.
b. Data requirement addressee. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study,
c. Author(s). Cite only individuals with primary intellectual
responsibility for the content of the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include m single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports
work done by one or more laboratories, Include on the title page
the name and address of the performing laboratory or laboratories,
and the laboratory's internal project number(s) for the work.
Clearly distinguish the laboratory's project identifier from any
other reference numbers provided by the study sponsor or submitter,
f. Supplemental Submissions, tf the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier study,
include on the title page elements a. through d. for the previously
submitted study, along with the EPA Naster Record Identifier (MEID)
or Accession number of the earlier study if you know these numbers.
(Supplements submitted In the same submittal package as the primary
study should be appended to and bound with the primary study. Do
not include supplements to more than one study under a single
title page).
g. Facts of Publication. If the study is a reprint of a pub-
lished document, identify on the title page all relevant facts
of publication, such is the journal titU, volun»«, issue, inclusive
page numbers, and publication date.
1
-------
D.2. Statements of Data Cotif ident ial i ty Claims Under FIF?A 510(d)(1),
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 SlSfl.33 (b) and (c).
(See Attachment 3) These statements apply only to claims of data
confidentiality based on pifra $10(d)(ihas , (b>, or (O. use
the appropriate alternative form of the statement either to
assert a claim of S10(d)(1> data confidentiality (S15B,33(b))
or to waive such a claim (SISd.33(c)). In either case, the
statement mast 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 NOTS Pg 13).
0,3. Confidential Attachment
If the claim is made that a study includes confidential busi-
ness information as defined by the criteria of FIFRA flQ(d)(l){A),
(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 mast 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
cover 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 S10(d)(l) on which the confidentiality
claim is based.
D.4* Supplemental statement of Data Confidentiality Claires (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)
(l)(A)t (B), or (C)« the following provisions applyi
- The specific information to which the claim applies mast be
clearly narked in the body of the study as subject to *
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 the typed name
and title of the official who signed it.
8
-------
D.5 Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirement# specified in 40 CFR 160, Sam-
pies of these statements are shown in Attachment 6.
£. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY SEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID 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
i'rtk, 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 points:
o Do not include frayed or torn pages.
o Do not include carbon copies, or copies in other than
black ink,
o Hake sure that photocopies are clear, complete, and fully
readable,
o Do not include oversize coeiputer printouts or fold-out pages.
o do not bind any documents with glue or binding tapes.
o Make sure that all pages of aach study, including any attach-
menta or appendices, are preaent and in correct sequence.
N-amber of Coplea Required - All aubniittal packagaa excapt
those associated with a Registration Standard or Special Review
(see part G below) bus* be provide* in three coapleta, identical
copies. (The proposed regulations apecifiad two copiaai thraa
are now being raquirad to expedite and reduce the coat of procea-
aing data into the OPP Pesticide Document Management Systea and
getting it into review.)
9
-------
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of conf ident i ality are made Cor 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
Claims1.
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 510(d)(1)(A), (B), or (CI. 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 Information
For further information contact William C. Grosse, Chief,
Information services Branch. Program Management and Support
Division, (703-557-2613).
u)
! u«mes W. Akerman
/Acting 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
Stattmtnta of Data confidentiality Claims
Supplemental Statement of Data Confidentiality Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
10
-------
ATTACHMENT 1.
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1• Name and address of submitter (or all joint submitters**)
'"Smith Chemical corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
tSmith Chemical Corp. will act as sole agent foe all submitters,
2. Regulatory action in support c£ 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 the data.
Company Officials ____ .
Name Signature
Company Names
Company Contacts ,
Name Phone
11
-------
ATTACHMENT 2.
SAMPLE STUDY TITLE PAGE FOR A NiWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5* 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Pag* 1 of X
(X Is eh* total number of pages in the study)
It
-------
ATTACHMENT 3.
STATEMENTS OF CM* CONFIDENTIALITY CLAIMS
1. Pto claim of confidentiality under FIFRA 510(d)(1)(A),(B), or (C)
STATEMENT OF NO DATA CONFirCKTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this stjdy
on the basis of it3 falling within the scorns of FIFRA 510(d)(1)(A), (B)» or (C).
Company
C&rnpany Agents Typed Harae Date;
Title Signature
2. Claim of confidentiality under FIFRA 510(d)(1)(A), (B), or (C).
STATEMENT OP DATA OONFIDBJTIALnY CLAIMS
Infonnation claimed confidential on the basis of Its Calling within the scope
of FIFRA 110(d)(1)(A), (B) # or (C) has been rcooved to a confidential appendix,
and is cited by cross-reference rurfcer in the body of the stady.
Canpany:
Ganpany Agent)
Title
Typed mm
D»te:
Signature
mmt Applicants for pensanent or terqporary tolerances should note that it
is OPP policy that no peeraansnt tolerance, t«nporary tolsranoe, or request fcr
an *nsrgency axsnption inoocporating an analytical method, can bs approved
unless the applicant waives all claims of conf identiality for ths analytical
Method, Them analytical Methods are published in the FDA Pesticide Analyt-
ical Methods Marual, ami therefore cannot be elated as oonfidtntial, OPP
iflplsnents this policy by returning submitted analytical «sthods, for %iiich
*hidi confidentiality elate have bean mads, to tha stfmitter, to obtain
ths confidentiality waiver before they can bs possessed.
13
-------
ATTACHMENT 4.
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA 510(d)(1)(A), (6), or (C5» but for which you claim
confidential treatment on another basis, the following informa-
tion roust be included within a Supplemental statement of Data
Confidentiality Claims:
o identify specifically by page and line number(s) 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 time—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 SPA, other Federal agencies, or courts
concerning this information.
o 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
-------
«TAOWENT 5.
EXAMPLES OF SEVERAL CONFICENT IAL ATTACHMENTS
Scanple 1 (Confidential wort or phrase that has been deleted Cran the study)
CROSS reference nuhber 1_ This cross reference amber is used in the stjdy J
in place of the following words or phrase at the j
indicated volune and page references. j
DELETED WORDS OR PHRASE s Ethylene Glycol |
BMSE LINE REASON FOR THE DELETION FIFRA REFERENCE |
6 14 Identity of Inert Ingredient 510(d)UHC)
28 25
100 19
Exanple 2 (Confidential paraqraph(s) that have been deleted frcra the study)
CROSS .SEFERSCE NUMBER
(S)i
111 is cross reference mmber is used in the study
in place of the following paragraphs) at the
indicated volum and page references.
(
PAGE:.
20.* *-J7
Reproduce the deleted paragraph(s) here
REASON FOR TOE DELETION
Ascription of the quality control process
)
FIFRA REFERENCE
SlQ(dXlHC)
Btanpie 3 *<3pnfidential pages that have been deleted fran the study)
CROSS JBRBBSNCE NUMBER 7 Ihis cross reference rmtme noted on a place-holder [
page is used in place of the following whole pages
at the indicated volune and page references,
DELEgp TWCEtSTi are attached ianediately behind this page,
asmm reascw for ihs dcletich nrm rsterbce
39-41 Description of product marufacturing process 110(d)(1)(A)
15
-------
ATTACHMENT 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 40 CFR
Part 160, and differs in the following ways:
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 ?.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document.
Belated Administrative Materials
(e.g., Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
studies, submitted as unique
physical entities, according
to the format below.
FORMAT OF SUBMITTED STUDIES
LEGEND
Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendleas to the study.
Title Pag* of the Confidential
Attachment.
Confidential Attachment.
—« Supplemental Statement
j. —-— of Confidentiality Claims.
| * When flagging requirements
are finalized.
- -1
Documents which must lie submitted as
appropriate to meet established requirements.
I
-J
Documents submitted at submitter's option.
17
-------
-------
ATTACHMENT D
EPA GROUPING OF END-USE PRODUCTS FOR MEETING
DATA REQUIREMENTS FOR REREGISTRATION
-------
EPA'S BATCHING TO FULFILL ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
OF PRODUCTS CONTAINING THE FOLLOWING ZINC SALTS: ZINC OXIDE, ZINC CHLORIDE AND
ZINC SULFATE
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for rereglstration of products containing the active Ingredients zinc oxide, zinc chloride
and zinc sulfate, 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 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 product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicologic^! studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other registrants,
or only their own products within a batch, or to generate all the required acute toxicological studies for
each of their own products. If a registrant chooses to generate the data for a batch, he/she must use one
of the products within the batch as the test material. If a registrant chooses to rely upon previously
submitted acute toxicity data, he/she may do so provided that the data base is complete and valid by
today's standards (see acceptance criteria attached), the formulation tested is considered by EPA to be
similar for acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED, The OCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days of
receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response," lists
the product specific data required for each product, including the standard six acute toxicity tests. A
registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend
on someone else to do so. If a registrant supplies the data to support a batch of products, he/she must
select one of the following options: Developing Data (Option 1), Submitting an Existing Study (Option 4),
Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on
another's data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6), If a registrant does not want to participate in a batch, the choices are
Options 1, 4,5 or e. However, a registrant should know that choosing not to participate in a batch does
not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option
3) those studies.
Some products were excluded from the batching process. Products which were not included in
the following batches were either considered not to be similar for purposes of acute toxicity or the Agency
lacked sufficient information for decision making purposes. Registrants of products which were not
batched are responsible for meeting the acute toxicity data requirements for each product.
-------
Table I.
Batch
EPA Rag. Mo.
% Zinc oxide
Formication type
1
524-354
99.4
powder
3096-18
99.0
powder
55500-1
99.9
strips
58494-1
99.0
strips
58509-1
99.0
strips
Table II.
Botch
EPA Reg. No.
% Zinc sulfate
Formulation type
2
802-591
99.0
granular
10699-1
99.0
dust
The following table show products that were either considered not to be similar for purposes of acute
toxicity or the Agency lacked sufficient information for decision making and were not batched. Registrants
of these products are responsible for meeting the acute toxicity data requirements for each product.
Table III.
EPA Reg, No.
* % Zinc oxide or
zinc chloride
Formulation iype
802-508
29.6 Zinc chloride
liquid
602-553
6.2 Zinc chloride
liquid
50019-1
20.76 Zinc oxide
2.35 Copper
powder
* expressed as metallic equiva
lent
-------
ATTACHMENT E
EPA ACCEPTANCE CRITERIA
-------
SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
-------
61 Product Identity and Composition
ACCEPTANCE CRITERIA
your study meet the following acceptance criteria?
Name of technical material tested (include product name and
trade name, if appropriate)
Name, nominal concentration, and certified limits (upper and
lower) for each active ingredient and each intentionally-
added inert ingredient
Name and upper certified limit for each impurity or each
group of impurities present at > 0.1% by weight and for
certain toxicologically significant impurities (e.g.,
dioxins, nitrosamines) present at <0.1%
Purpose of each active ingredient and each intentionally-
added inert
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
Molecular, structural, and empirical formulas, molecular
weight or weight range, and any company assigned experimental
or internal code numbers for each active ingredient
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
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 (tarxerscure,
pressure, humidity) controlled in each step and the
parameters that are maintained
Statement of whether process involves intended chemical
reactions
-------
8. (continued)
Flow chart with chemical equations for each intended
chemical reaction
Duration of each step of process
Description of purification procedures
Description of measures taken to assure quality of final
product
9. Discussion of formation of impurities based on established
chemical theory addressing (1) each impurity which may be
present at > 0.1% or was found at > 0.1% by product analyses
and (2) certain toxicologically significant impurities
(see #3)
-------
61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered. Items 1, 2, 3, and 5 can be
satisfied for most registered products by submission of the
Certified Statement of Formula Ingredients Page (EPA Form 8570-4).
Items 7 and 8 can be satisfied for most technical grade active
ingredients (TGAIs) by submission of a flow chart with chemical
equations for each intended chemical reaction. The flow chart
should include complete chemical structures and names for each
reactant and product of all the reactions.
1. Name of technical material (include product name and trade name,
if appropriate).
2. Description of each active and intentionally-added inert
ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert
ingredient.
5. Chemical name and Registry Number for each active and
intentionally-added inert ingredient (if available),
6. Molecular, structural, and empirical formulas, molecular weight,
and any experimental or internal code number for each active
ingredient.
7. Description of each beginning material in the manufacturing
process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
chemical theory.
-------
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1 . Five or more representative samples (batches in case of
batch process) analyzed for each active ingredient and all
. impurities present at > 0.1%
2 . Degree of accountability or closure > ca 98%
3 . Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites;
polyhalo^enated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines both fresh and stored
samples must be analyzed.]
4 . Complete and detailed description of each step in analytical
method used to analyze above samples
5 . Statement of precision and accuracy of analytical method
used to analyze above samples
6 . Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient
7 . Upper and lower certified limits proposed for each active
ingredient and intentionally added inert along with
explanation of how the limits were determined
8 . Upper certified limit proposed for each impurity present at
> 0.1% and for certain toxicologically significant
impurities at <0.1% along with explanation of how limit
determined
9 . Analytical methods to verify certified limits of each
active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally
recognized as safe by FDA) are fully described
10. .^.nalvVlcril r--thcds {as discussed 1", to vsrif'* isd
limits validated as to their precision and accuracy
-------
62 Analysis and Certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDISS
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 r.ethed(s) in item #9
.ii'crar.va xtsi #5 if app_ i jao-^d, .
-------
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 2 0-25° C
Density of technical grade active ingredient reported in
g/ml or the specific gravity cf liquids reported with
reference to water at 20° C. [Note: Bulk densjty of
registered products may be reported in lbs/ft or
lbs/gallon.]
-------
63-8 Solubility
Determined in distilled water and representative polar and
non-polar solvents, including those used in formulations
and analytical methods for the pesticide
Measured at about 20-25® C
Reported in g/100 ml (other units like ppm acceptable if
sparingly soluble)
63-9 Vapor Pressure
Measured at 25® C (or calculated by extrapolation from
measurements made at higher temperature if pressure too
low to measure at 25® c)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably
about 20 - 25° C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure
provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20 - 25° C
Measured following dilution or dispersion in distilled
water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
-------
63 Physical and Chemical Characteristics
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Description of color.
2. Description of physical state.
3. Description of odor.
4.. Indication of melting point (in C°).
5. Indication of boiling point (in C°).
6. Indication of density, bulk density, and specific gravity.
7. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant..
10. Indication of octanol/water partition coefficient.
11. Indication of PH.
12. Description of stability.
-------
SUBDIVISION F
Guideline Study Title
81-1. Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
81-7 Acute Neurotoxicity in the Hen
-------
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.
-------
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
-------
81-2 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 . Jit 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.
-------
81-2 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
-------
81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 . Identify material tested (technical, end-use product, etc)
2 . Product is a gas, a solid which may produce a significant
vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter
15 um or less).
3 . At least 5 young adult rats/sex/group
4 . Dosing, at least 4 hours by inhalation.
5 . Chamber air flow dynamic, at least 10 air changes/hour, at
least 19% oxygen content.
6 . Chamber temperature, 22° C (±2), relative humidity 40-60%.
7 . Monitor rate of air flow
8 . Monitor actual concentrations of test material in breathing
zone.
9 . Monitor aerodynamic particle size for aerosols.
10 . Doses tested, sufficient to determine a toxicity category
or a limit dose (5 mg/L actual concentration of respirable
substance).
11 . Individual observations at least once a day.
12 . Observation period to last at least 14 days.
13 . Individual body weights.
14 . Gross necropsy on all animals.
-------
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
-------
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 . Identify material tested (technical, end-use product, etc)
2 . Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3 . 6 adult rabbits
4 . Dosing, instillation into the conjunctival sac of one eye
per animal.
5 . Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if
a solid, paste or particulate substance.
6. Solid or granular test material, ground to a fine dust.
7 . Eyes not washed for at least 24 hours.
8 . Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal or
21 days (whichever is shorter).
9.* , individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-4 Primary lye 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.S
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 . Identify material tested (technical, end-use product, etc)
2 . Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3 . 6 adult animals.
4 . Dosing, single dermal.
5 . Dosing duration 4 hours.
6 . Application site shaved or clipped at least 24 hours prior
to dosing
7 . Application site approximately 6 cm.
8 . Application site covered with a gauze patch held in place
with nonirritating tape
9 . Material removed, washed with water, without trauma to
application site
10 . Application site examined and graded for irritation at 1,
24, 48 and 72 hr, then daily until normal or 14 days
{whichever is shorter).
11. * Individual daily observations.
Criteria marked with a * are supplemental and nay 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
dose your study meet the following acceptance criteria?
1 . Identify material tested (technical, end-use product, etc)
2 . ^ Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3 . One of the following methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig
4 . Complete description of test
5. * Reference for test.
6 . Test followed essentially as described in reference
document.
7 . Positive control included (may provide historical data
conducted within the last 6 months)
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-6 Dermal Sensitization in the Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
State if material is corrosive or has pH <2 or >11.5.
State specific method utilized
Complete description of specific method
Reference for the specific method employed
Note adherence of the protocol to that in the reference for
the specific method utilized
State the positive control tested
Significance of changes from Acceptance Criteria
-------
81-7 Acute Neurotoxicity in the Hen
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1 . Study performed on an organophosphate cholinesterase
inhibiting compound.
2 . Technical form of the active ingredient tested.
3. ± Positive control utilized.
4 . Species utilized, domestic laying hen 8-14 months of age,
5 . Dosing oral by gavage or capsule (dermal or inhalation
may be used).
6 . An acute oral LD is determined.
7 . Dose tested equal to an acute oral LD or a limit test of
5000 mg/kg.
8.1 Dosed animals may be protected with atropine and/or 2-
PAM.
9. Sufficient test animals so that at least 6 survive,
10 . Negative (vehicle) control group of at least 6 hens
11. * Positive control of at least 4 hens, (if used)
12 . Test dose repeated if no signs of delayed neurotoxicity
observed by 21 days after dosing.
13 . Observation period 21 days after each dose.
14 . Individual daily observations.
15 . Individual body weights.
16 . Individual necropsy not required.
17 . 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
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
-------
Page 1 of 1
United States Environmental Protection Agency
Washington,
D.
C. 20460
LIST
OF ALL REGISTRANTS SENT
THIS DATA CALL-IN
NOTICE
Case f and Nane:
4099 line salts
Co. Nr.
Company Name
Additional Name
Address
City & :;tate
Zip
000524
MONSANTO CO.
700 14TH STREET, N.W. SUITE
1100 WASHINGTON OC
20005
000002
CHAS H. LILLY CO.
7737 N.E. KILLIHGSWORTH
PORTLAND OR
97218
003098
BAXTER J Hi COMPANY
1700 S EL CAMIMO REAL
SAN MATEO CA
94402
OS0019
JAMES W. NIELSEN
BOX 6669
BROOKINGS O*
97415
0S5S00
WESPAC ENTERPRISES IDC
2415 S 200TH ST BOX 46337
SEATTLE MA
98146
0S8494
CANADIAN ROOFING PRODUCTS
5555 SAL 1SK RD
BLAINE WA
98250
058509
DAVID A. WALTZ IMPORTS
D/B/A HEN2IES SHEET METAL
13903 S.E. 14TH ST
VANCOUVER UA
96684
»
-------
ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORMS
-------
US E.-v'rorr-».-'u cfl Agercy
'AW^, DC 2060
J^CPA Product Specific
w Data Reocrt
*t$;stri;ian ror j£?A Nyma«r
t
i
i
"srm Acprcved
CV3 rX'Z-Xl-
ExC'"tt " %3C~55
Begiffttion
Guideline No.
Nam# of Teat
Teiting not
required 'ar my
product lifted
above
fC**c* Se'ow>
I am complying *itr>
Data a»c..ir»m#f.-i sv.
(Fo» EPA
Only)
*ce#«icn
"urst/t
»u-a-ta
| Su an rang Dtta
Citing MR ;D No. I f*tac^j
i fC.^eci smow)
Sec. 15a. 120
Product
Chemistry
01-1
ider.trty Of Ingredient*
81-8 fa^
Statement Of composition
i'-2 (b)
Oienuaaion 0* formation ingredient!
#2-1
Preliminary artalytia
I I
82*2
CerWeation of limits
I I
82-3
Analytical method* for enforcement limitt
I I
#3-2
Color
I
!
Mys»eai state
I
«3-4
Odor
#3-5
Melting point
83-8
Soiling {Mint
#3-7
Oenwy. talk-denaity, or specific gravity
934
Solubility
53-9
Vaoor pressure
¦ J.10
Oitaociation constant
i
#3-11
Octanai/water partition coefficient
S3*t2
pH
83-13
Stability
83-14
Oxidizing/reducing reaction
83-15
flamma&iiity
63.1#
S*ciodability
83-1?
Storage ttaSility
. S3-1»
VlieoaMy
83-19
MiteiOifitV
83-20
Corrosion Oaraetaristies
83-21
Dielectric breakdown voltage
StC 1S8.135
lexicology
n-1
Acute oral m*ic*ty, rat
¦i-a
Acute dermal toxicity, risttt/r*C/g.plg
H4
Acute mftalation toaioty. fit
¦1-*
Primary eye irritation, rabOit
«1-S
Wmaiy diffli Mtanon
#14
Dermal tanaMiaflaft
Certification
I cerufy that the statements I have made on this form and all attachments thereto are
• true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
Typtd Nunc and Tit*
Signature
~
Oat*
.PA form tSMO-* {Km. S-M) Prewoua eCitwi » 96M«t*.
-------
United Siatts Environmental Protection Agency
A 1™A Washington, DC 20480
nrKtt CERTIFICATION OF OFFER TO COST
Mil I 1 SHARE IN THE DEVELOPMENT OF DATA
Porn Approvtd
QUB Ne. 2070-010t
Apprtvml tiplrt*
Public reporting bunJ«n for this collection of information is estimated to av«rag« 15 minutes per response, including
tiro# 'or reviewing instructors, Marching Misting data sources. gathering and maintaining the data needed, and
completing and reviewing the collection of information. Sand oommants regarding the burden astimata or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to tn« Oflice
of Management and Budget, Paperwortc Reduction Project (2070-0106), Washington, OC 20503.
Pfeeee fill In blenka below.
Cwnpany Nan*
Produce Man*
EPA Reg. No.
I Certify that:
My company ta willing to davtlop and submit the data required by EPA under tha authority of tha Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my oompany would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered In writing to enter into sued an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(9)(iii} of FIFRA if final agreement on all
terns could not be reached otherwise. This offer was made to the following firm(s) on the following
date(i):
Mad* •( Finnfe)
1
Data at Offtr
lion:
I»n^th«limdufy»uthorc#
------- |