&EPA
......onnwnttl Protection
AgMicy
PMtlctdM and Toxic Sutattnott
WMhington DC 20460
540/RS-89-023
PMtteMM
December 1988
Guidance for the
Reregistration of
Pesticide Products
Containing
Bacillus thuringiensis
as the Active Ingredient
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OMB Control No. 2070-0057
Expires November 1989
REGISTRATION STANDARD
FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
Bacillus thuringiensis
AS THE ACTIVE INGREDIENT
CASE NUMBER 0247
OPP Chemical Codes: 006401, 006402, 006403,
006405, and 128946
DECEMBER 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Microbial Pesticide Covered by this Standard 3
A. Description of Microbial Pesticide 3
B. Use Profile . 4
III. Agency Assessment 8
A. Identity of the Active Ingredient 9
B. Mode of Activity 10
C. Human/Mammalian Health Effects 10
D. Ecological Characteristics 11
E. Tolerance Reassessment 12
IV. Regulatory Position and Rationale 14
A. Regulatory Positions 14
B. Criteria for Registration 19
C. Acceptable Ranges and Limits 19
D. Required Labeling 19
V. Products Subject to this Standard 23
VI. Requirement for Submittal of Generic Data 25
A. What are generic data? 25
B. Who must submit generic data? 25
C. What generic data must be submitted? 26
D. How to comply with DCI requirements 27
E. Registrant Requests Regarding Data
Requirements and Agency Responses 29
F- Test Protocols and Standards 29
G. Procedures for requesting a change in protocol . . 30
H. Procedures for requesting extensions of time
I. Data Format and Reporting Requirements 30
J. Existing stocks provisions upon suspension or
cancellation 30
VII. Requirement for Submittal of Product-Specific Data . . 31
VIII. Requirement for Submittal of Revised Labeling 31
IX. instructions for Submittal 32
A. Manufacturing use products (sole active) 32
B. Manufacturing use products (multiple active) ... 33
C. End use products (sole active) 34
D. End use products (multiple active) 34
E. Intrastate products 35
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APPENDICES
I. DATA APPENDICES
Guide to Tables 37
Table A 40
Table B 40
Table C 49
II. LABELING APPENDICES
Summary of label requirements and table .... 50
40 CFR 156.10 Labeling Requirements 59
Physical/Chemical Hazards Labeling Statements . 64
Storage Instructions 65
Pesticide Disposal Instructions 66
Container Disposal Instructions 67
III. FORMS APPENDICES
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet . 68
EPA Form 8580-3 Generic Data Exemption Statement . 69
EPA Form 8580-4 Product Specific Data Report ... 70
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data 71
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
ARC Anticipated Residue Contribution
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
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.
LD50 Median lethal dose - a statistically derived single dose
than can be expected to cause death in 50% of the test
animals, when administered by the route indicated
(oral, dermal, inhalation). It is usually expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
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PADI Provisional Acceptable Daily Intake
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
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I. INTRODUCTION
EPA has established the Registration Standards program in
order to provide an orderly mechanism by which pesticide products
containing the same active ingredient can be reviewed and
standards set for compliance with FIFRA. The standards are
applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling into
compliance with FIFRA, as instructed by this Standard.
The Registration Standards program 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" criteria of
FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been required
when the product was initially registered or may be needed to
replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product is
not misbranded and that the labeling is adequate to protect man
and the environment.
The detailed scientific review, which is not contained in
this document, but is available upon request1, focuses on the
pesticide active ingredient. The scientific review primarily
discusses the Agency's evaluation of and conclusions from
available data in its files pertaining to the pesticide active
ingredient. However, during the review of these data the Agency
is also looking for potential hazards that may be associated with
the end use products that contain the active ingredient. The
Agency will apply the provisions of this Registration Standard to
end use products if necessary to protect man and the
environment.
EPA's reassessment results in the development of a
scientific reviews and Compendium of Acceptable Uses
may be obtained from the OPP Public Docket, Field Operations Division,
by calling (703) 557-2805 or by writing EPA, Public Information Branch, FOD,
401 M Street, S.W., Washington, DC 20460.
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regulatory position, contained in this Registration Standard, on
the pesticide and each of its registered uses. See Section IV-
Regulatory Position and Rationale. Based on its regulatory
position, the Agency may prescribe a variety of steps to be taken
by registrants to maintain their registrations in compliance with
FIFRA. These steps may include:
1. Submittal of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in the
issuance of a Notice of Intent to Cancel or a Notice of Intent to
Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the pesticide.
If the Agency determines that the risks of the pesticide's use
outweigh the benefits of use, the Agency may propose additional
regulatory actions, such as cancellation of uses of the pesticide
which have been determined to cause unreasonable adverse effects
on the environment.
EPA has authority under the Data Call-In (DCI) provisions of
FIFRA sec. 3(c)(2)(B) to require that registrants submit data to
answer our questions regarding the chemical, toxicological, and
environmental characteristics and fate of a pesticide. This
Registration Standard lists the data EPA believes are necessary
to resolve our concerns about this pesticide. These data are
listed in the Tables A, B, and C in Appendix I. Failure to comply
with the DCI requirements enumerated in this Registration
Standard may result in issuance by EPA of a Notice of Intent to
Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they become
aware of such information. Registrants must notify
the Agency of any information, including interim or preliminary
results of studies, if that information suggests possible adverse
effects on man or the environment. This requirement is
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independent of the specific time requirements imposed by EPA for
submittal of completed studies called in by the Agency and
continues as long as the products are registered under FIFRA.
II,
MICROBIAL PESTICIDES COVERED BY THIS STANDARD
A. DESCRIPTION OF MICROBIAL PESTICIDES
This Standard covers microbial pesticides containing the
microorganism Bacillus thuringiensis as described in Volume 2 of
Beraev's Manual of Systematic Bacteriology. 1986 edition, and in
section IV.A. of this Registration Standard.
Identifying nomenclature and codes of currently registered
subspecies are shown below. (Although the Agency and industry
have used the term "variety" in the past, the correct taxonomic
designation is "subspecies.")
Microbial Pesticide Name: Bacillus thurinoiensis (all
OPP Chemical Code: 006401 subspecies)
Microbial Pesticide Name: Bacillus thuringiensis subsp.
OPP Chemical Code: 006401 israelensis
Microbial Pesticide Name:
OPP Chemical Code: 006402
Microbial Pesticide Name:
OPP Chemical Code:006403
Microbial Pesticide Name:
OPP Chemical Code: 128946
Microbial Pesticide Name:
OPP Chemical Code: 006405
Bacillus thuringiensis subsp.
kurstaki
Bacillus thuringiensis subsp.
aizawai
Bacillus thuringiensis subsp.
san diego
Bacillus thuringiensis subsp.
tenebrionis
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B. USE PROFILE
Type of Pesticide: Microbial
Mode of Action: Insect toxicity
Target Pests:
Bacillus thurinoiensis subsp.
israelensis;
mosquito (larvae), fungus gnats (larvae),
and black flies (larvae);
B_.t. subsp. aizavai; Greater wax moth
(larvae);
B.t. subsp. kurstaki; Lepidopterous larvae
l.t. subsp. san diecro; Colorado potato beetle
(larvae) and elm leaf beetle (larvae and
adults)
Registered Uses:
B.t. subsp. israelensis:
MPs - 4
EPs - 30
24(c)s - 1
Terrestrial food crop use on
pastures;
Aquatic food crop use on rice;
Aquatic nonfood crop use on brackish
water, mangrove swamps, salt marshes,
tidal water, drainage systems,
irrigation systems, flood water areas,
woodland pools, standing water,
polluted water, sewage waste
lagoons, ponds, lakes, and
streams;
Greenhouse nonfood crop use on orna-
mental plants;
Domestic outdoor use on standing water
around the dwellings.
B.t. subsp. aizawai;
EPs - 1
B.t. subsp. kurstaki:
MPs - 7
EPs - 161
24(c)s - 56
Indoor use on empty honeycombs,
Terrestrial food crop uses on
cotton, corn, soybeans,
sorghum (grain crop), small
grains, hops, fruits (banana,
blueberry, caneberries,
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cranberry, currant, citrus fruits,
grapes, kiwi fruit, pome fruits, stone
fruits, small fruits, strawberry,
tropical fruits, vegetables
(artichoke, asparagus, avocado, beans,
beets, carrots, celery, cole crops,
cucumber, dandelion, eggplant, endive,
lentils, lettuce, melons, okra,
onions, parsley, parsnip, peas,
pepper, potato, pumpkin, radish,
rutabaga, safflower, spinach, squash,
sugar beets, sugar maple, sunflower,
sweet potato, Swiss chard, ti,
tomato, watercress, watermelon), nuts
(nut crops, nut trees, peanut, walnut),
flavoring and spice crops, garlic,
horseradish, mint, salisfy, and forage
crops, alfalfa, hayage, pastures and
rangelands;
Terrestrial nonfood crop uses on
tobacco, ornamental flowering and
herbaceous plants, ornamental and/or
shade trees, and ornamental turf;
Aquatic food crop use on rice and wild
rice;
Greenhouse food crop uses on beans,
beets, carrots, celery, cole crops,
cucumber, eggplant, endive, flavoring
and spice crops, garlic, lentils,
lettuce, melons, onions, parsley,
peas, peppers, potato, radish,
spinach, squash, sweet potato,
strawberry, tomato.
Greenhouse nonfood crop uses on
agricultural research crops and
ornamental flowering, herbaceous
and woody plants;
Forestry uses on forest trees;
Indoor uses on stored birdseed; herbs,
spices, and condiments; grain crops;
peanuts; agricultural and oil seeds;
soybeans, sunflower, and tobacco
(including flue-cured).
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fi.t. subsp. san dieao:
EPs - 1
£.£• subsp. tenebrionis!
EPs - 1
Terrestrial food crop uses on egg-
plant, potato and tomato;
Terrestrial nonfood crop uses on elm
trees.
Terrestrial food crop use on
potatoes.
Methods of Application: Hand sprayer; water treatment by
aerial or ground equipment; soil
application by drip or overhead
irrigation systems; foliar application
by aerial, conventional ground or
hand-held equipment and
center-pivot irrigation systems;
sprayer or sprinkler cans.
Rates of Application:
fi.t. subsp. israelensis:
Terrestrial food crop - 0.14 to 1.82
billion AA*IU*/A
Aquatic food crop -
0.14 to 1.82 billion AA IU/A
Aquatic nonfood crop - 0.14 to 2.54
billion AA IU/A
0.001 to 0.04 billion AA IU/100 sq ft
3,785 to 409,600 AA lU/gal treated
water
Greenhouse nonfood crop-0.31 to 2.42
billion AA IU/100 gal
Domestic outdoor - 0.001 to 0.004
billion AA IU/100 sq ft
JJ.t. subsp. kurstaki;
Terrestrial food crop - 0.73 to 29.04
billion IU*/A
Terrestrial nonfood crop-0.125 to
24.0 billion IU/A
1.67 to 4.06 billion IU/5,000 sq ft
Greenhouse food crop - 0.10 to 1.01
billion IU/2,500 sq ft
Greenhouse nonfood crop-0.20 to 0.3
billion IU/2,500 sq ft
Forestry - 0.125 to 24.0 billion IU/A
Indoor - 7.26 to 27.25 billion
IU/1,000 sq ft
27.23 to 65.6 billion IU/1,000
bushels
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Formulations;
JJ.£. subsp. aizawai;
Indoor - 0.003 billion GM* IU/frame
fi.t. subsp. san dieoo;
Terrestrial food crop - 44.5 to 133.5
billion CBP*IU/A
Terrestrial nonfood crop-89 to 178
billion CPB IU/100 gal
fi.£. subsp. tenebrionis;
Terrestrial food crop - 12.6 to 18
billion tenebrionis units/A
Technicals, formulation intermediate, dusts,
granular, pelleted/tablet, wettable powder,
emulsifiable concentrate, flowable concentrate,
ready-to-use, and pressurized liquid.
Basic Producers: Bacillus thurinqiensis subsp. israelensis
- Abbott Laboratories, Chicago, IL
- Duphar B.V., Weesp, Holland
- Novo Industri AS, Copenhagen, Denmark
- Zoecon Corporation, A Sandoz Company
Dallas, Texas
Bacillus thurinqiensis subsp. kurstaki
- Abbott Laboratories, Chicago, IL
- Duphar B.V., Weesp, Holland
- Novo Industri AS, Copenhagen, Denmark
- Sandoz Crop Protection Corp.,
Des Plaines, IL
- Ecogen, Inc., Langhorne, PA
Bacillus thurinqiensis subsp. aizawai
- Sandoz Crop Protection Corp.,
Des Plaines, IL
Bacillus thurinqiensis subsp. san dieqo
- Mycogen Corporation, San Diego, CA
Bacillus thurinqiensis subsp. tenebrionis
- Sandoz Crop Protection Corp.,
Des Plaines, IL
Year of Intitial
Registration:
1961
* AA - Aedes aeqypti
IU « International Units
GM = Galleria mellonella
CPB = Colorado potato beetle
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III. AGENCY ASSESSMENT
The Agency reviewed and evaluated available data, including
both data submitted to the Agency in support of registration of
£• thurinoiens^s as an active ingredient and data from the
published literature. This information served as the
basis for issuance of a draft Registration Standard in 1986.
On October 10, 1986, the Agency informed the public regarding the
availability of the draft Registration Standard for comment in
the FEDERAL REGISTER, 51 FR 37488. In the comment period of two
months, five commenters responded to the Agency. All comments
have been taken into consideration in the issuance of this final
Registration Standard. The specific comments, as well as the
Agency's responses, are present in the public docket assigned to
this Registration Standard.
In the 1986 draft Registration Standard, the Agency
concluded that adequate data were available to assess the
toxicological and other biological effects of B.. thuringiensis
on mammals, that no data gaps existed in the toxicology data
base, and that there were no substantial human or environmental
safety concerns except for certain endangered lepidopteran insect
species. Although substantial gaps were found to exist in the
ecological effects data base, there were no substantive concerns
regarding unreasonable adverse effects of B.. thuringiensis for
the registered products. Therefore, the Agency concluded that
the use of B. thuringiensis products could be continued, and that
products could be used as registered, with only minor
precautionary labeling changes and additional nontarget organism
data being required.
Since the issuance of the 1986 draft Registration Standard,
the Agency has revised the Pesticide Assessment Guidelines
Subdivision M, reassessed endangered species hazard, and
reviewed additional data on B. thuringiensis. The Agency has
also more keenly focused on product identity; i.e., strain-to-
strain variability within subspecies designations. Current
methods applicable to strain identification have advanced
considerably since the initial B.. thuringiensis registration
(1961). As with conventional chemical products, it is essential
to know product identity so that the applicability of test
results, i.e. toxicity testing and host range, can be related to
specific products. A major focus of this Registration Standard
is to obtain state-of-the-art identification data on B..
thurincriensis strains. Each registered strain must be placed in
a recognized culture collection and is subject to the data
requirements of this Standard.
Although the data submitted to the Agency since 1986 show
rodent and nontarget organism effects, these data do not change
the assessment of the draft 1986 Registration Standard
that there is no evidence of any substantial human or
environmental safety concerns related to current uses of B_.
thuringiensis.
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A. Identity of the "Active Ingredient" (Strain/Subspecies)
Currently, the Agency groups B_. thurinaiensis active
ingredients according to the subspecies designation of the strain
(i.e., all strains of one subspecies are one active ingredient).
There were 3 active ingredients registered prior to the 1986
draft Registration Standard (subspecies kurstaki. israelensis.
and aizawai) and two more have been registered since then
(subspecies san diego and tenebrionis).
Taxonomic classification of subspecies (and therefore
designation of active ingredient) is based almost entirely upon
flagellar antigen serotyping. Serotype designation is not
necessarily indicative of pesticidal activity. Therefore, the
current system classifies active ingredients in a manner that
does not necessarily have a bearing on the actual active
ingredient (e.g., insecticidal toxins). In fact, delta endotoxin
genes are resident on plasmids and can be transferred among JJ.
thurinqiensis strains, potentially changing toxin production
without changing the flagellar antigen serotype.
Therefore, the Agency no longer recognizes flagellar antigen
serotyping as sufficient by itself to classify strains for
pesticide regulatory purposes. Instead, the Agency will classify
strains based on the identification data required by this
Registration Standard, including biochemical and morphological
data, flagellar antigen serotype analysis, strain history,
antibiotic resistance patterns, description of the insecticidal
toxins produced, plasmid profiles, morphological description of
crystalline proteins, bioassays for insect host range, and the
mouse intraperitoneal toxicity/pathogenicity screen.
Strain variability is a phenomenon that further complicates
the regulation of B. thurinqiensis products and the use of data
derived from the testing of one strain to support conclusions
drawn concerning another strain. The Agency defines a B_.
thurinqiensis strain as being made up of descendants of a single
isolate in pure culture that are essentially the same as the
original isolate with respect to the characterization data being
required by this Registration Standard. Strains originally
registered with the Agency have, in all probability, become
modified or been replaced so that it is possible that data
supporting the registration of the original strain may not be
sufficient to support the strain currently in the registered
pesticide product. The Agency will use the characterization
data, further described in the Regulatory Position and Rationale
and in the Data Tables, to more accurately reclassify the
different strains of B.. thurinqiensis into distinct active
ingredients.
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B. Mode of Activity
B. thurinaiensis's pesticidal effects are attributable
primarily to protein toxins. The best known of these are the
lepidopteran and dipteran active PI or delta endotoxin and the
dipteran active P2 endotoxin. These protoxins are apparently
solubilized in the alkaline midgut of the lepidopteran and
dipteran larvae. The protoxin is then enzymatically digested to
the active toxin which damages the midgut lining and allows
midgut material to diffuse into the hemolymph with consequent
elevated pH and paralysis of the insect.
B. thurincriensis strains also produce toxins that are
active against other insects. However, the presence of these
toxins in B. thuringiensis pesticide products is not fully known.
Therefore, this Standard requires the submission of data to
determine the presence of these toxins.
C. Human/Mammalian Health Effects
B. thuringiensis was one of the first insect pathogens
registered in the United States and was required to undergo
what, at the time, was a rigorous toxicity/infectivity
evaluation. Much of the original testing for B. thurinaiensis
was based on the testing requirements for conventional chemical
pesticides. In 1986 when the draft Registration Standard was
issued, there were no significant human health concerns and
no mammalian toxicity/ infectivity data gaps for B.
thurinaiensis. Many studies conducted prior to the issuance of
the 1986 draft were conducted using several routes of
administration in rats, mice, rabbits, and guinea pigs.
These data indicate that if there are any deleterious effects
caused by the use of products containing B. thurinaiensis. they
are very minimal. Most of the data are on B. thuringiensis
subspecies kurstaki and israelensis. These studies were
conducted before EPA issued-testing-guidelines—and hence
lack__unif ormity_in -reporting-of-dose—levels— (e. g-*—#-
spores/animal-, -grams- of- spores/t Ddy-weightr-or-gramsyof
spores/animal). Thus, a comparative assessment is impossible.
Data submitted subsequent to the 1986 draft Registration
Standard shows acute toxicity when very high levels of certain
B. thurinaiensis strains are administered to test rodents via
the pulmonary/and or intravenous routes. The Agency is uncertain
whether the adverse effects observed in rodents after
acute pulmonary exposure or acute intravenous exposure to
high levels of B. thurinaiensis are relevant to other larger
mammals including humans. When the data required by this
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Registration Standard are received and reviewed, the Agency
should be able to better assess risks to human health from
registered strains of B. thurinaiensis and to determine the
applicability of these data to each registered strain. In order
to determine the significance of the effects observed at high
dose levels in rodents, the Agency currently is investigating
(via cooperative agreement with IIT Research Institute)
nonspecific toxic effects related to particle size, particle
number, and to differential toxicities related to pulmonary and
intravenous exposures.
The Agency has received no reports of adverse pulmonary or
intravenous effects in exposed humans related to current uses of
B.. thurinaiensis.
D* Ecological Characteristics
Prior to the 1986 draft Registration Standard, the
Agency reviewed numerous ecological effect studies submitted in
support of the registration of £. thuringiensis products, as well
as studies in the open literature, to assess the potential risks
to nontarget organisms posed by the registered uses of B..
thurinoiensis. In general, the data indicated no adverse effects
on nontarget insects, birds, and mammals. The applicability of
these data will be determined once the characterization data are
submitted on each registered strain.
1. Aquatic Organisms - Data Submitted Prior to the 1986
Draft Registration Standard
Few toxic effects have been reported in studies on
B. thuringiensis exposure to aguatic species. A study conducted
with an end use product containing 3.2% £. thurinoiensis
subspecies kurstaki. with a potency of 16,000 lUs per milligram
of product, suggests possible toxicity to mussels and brine
shrimp. This was a static tank test in which the test organism
were subjected to various doses of this product for 96 hours.
The highest dose tested with mussels (400 ppm) showed 28 percent
mortality; the highest dose tested with brine shrimp showed 90
percent mortality.. The LCso for shrimp was calculated at 85 mg/L
(85 ppm). However, it could not be determined whether the
reported mortalities were the results of toxic effects of the
microbial pesticide or due to other factors. Hence, the data are
considered inconclusive.
2. Invertebrates - Data Submitted Prior to the 1986 Draft
Registration Standard
Studies of populations of nontarget terrestrial
invertebrate organisms following applications of B..
thurinaiensis to fields have not revealed significant adverse
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effects on nontarget invertebrates. In field tests in Nova
Scotia, where fi. thurinaiensis was the only insecticide applied
to an apple orchard over a 4-year period, population levels of
Lepidopteran target insects were reduced, but there was no
reported effect on beneficial predacious insects.
High concentrations of fi. thurinaiensis subspecies
kurstaki spores have been found to be toxic to bees and
earthworms; however, toxicity only occurred at concentrations
greater than those expected with normal pesticide application.
3. Data Submitted After the 1986 Draft Registration
Standard
Since the 1986 draft Registration Standard was written,
data have been submitted which show acute toxicity in birds (178
ppm LD50 and 1 ppm NOEL) and suggest adverse effects in
freshwater fish, plants, aquatic invertebrates, and rare
beneficial insects. The contribution of inert ingredients to
toxicity as well as the relevance to environmental risk of routes
of exposure and dose levels used in testing have yet to be
determined. Therefore, whether these results show hazard to
nontarget organisms in the environment cannot be determined until
additional data are submitted.
4. Endangered Species
Risk to federally listed endangered species cannot
be fully.determined at this time. However, the U.S. Fish and
Wildlife Service (FWS) has determined (1987) that certain uses of
the subspecies kurstaki jeopardize the continued existence of the
Kern primrose sphinx moth, Lange's metalmark butterfly, Smith's
blue butterfly, El Segundo blue butterfly, Oregon silverspot
butterfly, San Bruno elfin butterfly, Lotis blue butterfly, and
the Schaus swallowtail butterfly. An earlier consultation
(1984) with FWS addressing rangeland/pastureland pesticide use
found that B_. thuringiensis (subspecies not specified)
jeopardize the existence of the Kern Primrose Sphinx moth, Delta
Green Ground Beetle, and the Valley Elderberry Longhorn Beetle.
As some B. thuringiensis products have activity against
dipterans, these prpducts could effect any endangered dipterans
that may be listed in the future.
5. Tolerance Reassessment
An exemption from the requirement of a tolerance has
been established for the viable spores of £. thuringiensis on
raw agricultural commodities (RACs) under the provisions of 40
CFR 180.1011. The Agency has determined that all products and
uses covered by this Registration Standard must abide by the
provisions of the tolerance exemption, including nonfood use
products. The tolerance exemption regulation requires that the
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microbial insecticide for which exemption from the requirement
of a tolerance is established shall have the following
specifications:
a. The microorganism shall be an authentic strain of B..
thurinqiensis Berliner conforming to the morphological and
biochemical characteristics of fi. thurinqiensis as described in
Berqev's Manual Of Determinative Bacteriology. Eighth Edition.
b. Spore preparations of fi. thurinqiensis shall be
produced by pure culture fermentation procedures with adequate
control measures during production to detect any changes from the
characteristics of the parent strain or contamination by other
microorganisms.
c. Each lot of spore preparation, prior to the
addition of other materials, shall be tested by subcutaneous
injection of at least 1 million spores into each of five
laboratory test mice weighing 17 to 23 g. Such tests shall show
no evidence of infection or injury in the test animals when
observed for 7 days following injection.
d. Spore preparations shall be free of B.. thurinqiensis
beta-exotoxin when tested with the fly larvae toxicity test
("Microbial Control of Insects and Mites," R.P.M. Bond et al., p
280 ff., 1971). This specification can be satisfied either by
determining that each master seed lot brought into production is
a B. thurinqiensis strain which does not produce beta-exotoxin
under standard manufacturing conditions or by periodically
determining that beta-exotoxin synthesized during spore
production is eliminated by the subsequent spore-harvesting
procedure.
The exemption from the requirement of a tolerance is
established under 40 CFR 180.1011 for residues of the microbial
insecticide B. thurinqiensis in or on beeswax and honey, and all
other RACs when B. thurinqiensis is applied either to growing
crops, or when applied after harvest, in accordance with good
agricultural practices.
The 40 CFR 180,1011 tolerance exemption for B,. thurinqiensis
is currently being reevaluated by the Agency. This reevaluation
will continue as data submitted in response to the Registration
Standard are reviewed. Areas which the Agency wishes to address
in this reevaluation include the scope of the exemption (e.g.
whether asporogenic strains should be included), quality
assurance measures, limits or restriction on the presence of
beta-exotoxin and whether or not the mouse subcutaneous test
should be replaced with a mouse intraperitoneal test.
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The 40 CFR 180.1001 (c) inert tolerance exemption for JJ.
thurinqienaSg fermentation solids and/or solubles is also
currently being reevaluated by the Agency as product analysis
data are submitted in response to the Registration Standard.
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
1. The Agency is requiring a specific set of tests designed to
better characterize registered strains of Bacillus
thurinqiensis. The Agency defines a B.. thurinqiensis strain
as being made up of descendants of a single isolate in pure
culture which are essentially the same as the original
isolate when characterized by the data being required by
this Registration Standard. The Agency will use these data
to reclassify registered strains into groups of strains with
similar characteristics. These new groupings, based upon
the characterization data required by this Registration
Standard, will form the basis for active ingredient
designation of B. thurinaiensis products.
Rationale - The Agency's current practice of grouping B.
thuringiensis active ingredients by subspecies is not suffi-
ciently specific to insure that all products within a group
have substantially similar pesticidal characteristics. The
taxonomic subspecies (Although the Agency and industry have
used the term "variety" in the past, the correct taxonomic
designation is "subspecies.") designation for JJ.
thuringiensis is based largely upon the flagellar antigen
serotyping of the subject strain. Many insecticidal toxin-
producing genes are resident in plasmids and, therefore,
may be exchanged between different subspecies of B.
thurinqiensis as well as certain other Gram-positive bac-
teria and may not alter the flagellar antigens. Because
changes in activity and host range may not be reflected by
changes in the flagellar antigens, flagellar serotyping
is an inadequate method in and of itself for regulatory
purposes.
2. The following nine characterization data are required for each
B.. thurinqiensis strain currently registered. Refer to
Appendix I, Tables A and B for further information.
a. Standard biochemical and morphological testing for JJ.
thurinqiensis. as specified in the 1986 edition of
Sergey's Manual of Systematic Bacteriology and
subsequent additions.
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b. Flagellar antigen serotype analysis, as described by de
Barjac.
c. History of the strain.
d. Standard, Gram-positive, antibiotic susceptibility
patterns.
e. Description of insecticidal toxins produced.
f. Plasmid profiles.
g. Morphological description of crystalline proteins.
h. Bioassays for insect host range.
i. Mouse intraperitoneal toxicity/pathogenicity screen.
Rationale - The flagellar antigen serotype designation of de
Barjac is not adequate by itself to clearly identify and
group different B. thuringiensis strains for regulatory
purposes. The above characterization data will allow the
Agency to better classify the strains of B. thurinaiensis
that are present in registered products. In addition, these
data will provide the Agency with information to allow for a
more accurate determination of whether or not data can be
shared between closely related strains of £. thuringiensis.
3. Each distinct strain, including each strain within a
subspecies, is subject to all the data requirements ap-
plicable to the use pattern(s) of that strain. In order to
utilize data submitted to the Agency
prior to the issuance of this Registration Standard,
registrants must show that the strain used in testing
is substantially similar to the strain present in the
product currently.
Rationale - Due to the current Agency grouping of £.
thuringiensis by subspecies and the variability of strains
within a subspecies, data supporting one strain within a
subspecies may not be adequate to support another strain in
the same subspecies.
4. Each registrant must establish the number of B.. thurinoien-
sis strains present in their product based upon the charac-
terization data detailed in the paragraph 2 above. If more
than one strain is present, then each strain will be subject
to the requirements set forth in this Registration Standard.
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Rationale - Testing performed on one of the £. thuringiensis
strains present in a particular product may not adequately
describe the properties of any other B. thurinaiensis strain
present.
5. A pure culture of each B. thurinaiensis strain to be
registered is to be deposited in a recognized national or
international culture collection. Within 12 months, each
registrant must identify for the Agency which culture
collection has been chosen as a strain depository. Also,
batch-to-batch genetic variation is to be minimized
by use of seed derived from aliquots of a large initial
batch of the strain on which the mammalian and environmental
studies were conducted. Registrants should periodically
test subsequent aliquot producing batches, grown from an
aliquot of the original aliquot producing batch, to assure
that strain variation has not taken place. Such variation
would include change in host range, quantity (unrelated to
culture conditions) and types of toxins produced, etc.
Rationale - The above requirement will help assure that B.
thurincriensis strains in commerce do not change over time
or, if they do, that the Agency has adequate data to
characterize any such change.
6. Based upon data submitted in response to this Registration
Standard, the Agency intends to reevaluate the current
tolerance exemption for B. thuringiensis in Section 180.1011
of Title 40 of the Code of Federal Regulations (40 CFR
180.1011) and the inert tolerance exemption for B. thurin-
giensis fermentation solids and/or solubles in 40 CFR
180.1001(c)
Rationale - Questions regarding potential hazards (such as
possible human pathogen or toxin contaminants) cannot be
reevaluated until data required by the Standard have been
submitted and reviewed.
~J__. The batch^to-r-batch-tes-ting—requirements-currently set forth
for food—use-B«-^thurinaiens-is products^ in-40—CFR 180.1011,
will be required of nonfood use B. thuringiensis products,
such as those intended for forestry use.
Rationale - Analysis for production batch contaminating
microorganisms and their metabolites is not currently
required of nonfood use products, such as those used in
forestry programs. In order to assure public and applicator
safety, the Agency believes such testing requirements need
to be imposed on all B. thurinqiensis products.
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8. The amount of active ingredient must be determined by a
specific and quantitative assay for the insecticidal toxins
present in the product and be expressed as a percentage of
the total product weight. The Agency hereby rescinds PR
Notice 71-6, which set the requirement for determining
percent active ingredient based on the potency of the spore
preparation.
Rationale - The toxins that B_. thurinaiensis produces are
the primary factor contributing to insect toxicity- The
percent of active ingredient is thus best quantified by
determining the amount of these toxins present in the
product.
9. This standard will cover all naturally occurring strains
of B. thurinaiensis as well as those strains that have
been altered via plasmid curing and/or intraspecies
transconjugation. Strains altered in a manner other than
described here will be registered on a case by case basis in
accordance with the Agency's evolving policies and
procedures. Organisms other than J3. thurinaiensis that
have been engineered to contain genes from B. thurinaiensis
will not be covered by this Registration Standard.
Rationale - The Agency considers such genetically engineered
pesticidal products to have the potential to be sufficiently
different to warrant testing and risk assessment on a case-
by-case basis.
10. The Agency is not requiring data on ground water.
Rationale - There is no evidence that B. thurinaiensis poses
a health risk via the oral route of exposure. Hence, there
is no evidence to raise a ground water concern.
Furthermore, B.. thurinaiensis exists in the soil under
natural conditions throughout the world.
11. Risk to federally listed endangered species from the use of
B_. thuringiensis cannot be fully determined at this time.
However, the U.S. Fish and Wildlife Service (FWS) has
determined (1987) that certain uses of the subspecies
kurstaki may jeopardize the continued existence of the Kern
primrose sphinx moth, Lange's metalmark butterfly, Oregon
silverspot butterfly, Mission blue butterfly, San Bruno
elfin butterfly, Lotis blue butterfly, and the Schaus
swallowtail butterfly. In addition, a 1984 Biological
Opinion from the Fish and Wildlife Service on potential
threats to endangered species from pesticides used on range
and pastureland declares that ]5. thurinaiensis (subspecies
17
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unspecified) jeopardize the continued existance of of the
Kern Primrose Sphinx moth, Delta Green Ground Beetle, and
the Valley Elderberry Longhorn Beetle.
EPA is developing a program to reduce or eliminate exposure
to endangered species to a point where pesticide use does
not result in jeopardy, and will issue notice of any
necessary labeling revisions when the program is developed.
As explained below, labeling requirements issued in PR
Notices 87-4 and 87-5 have been withdrawn pending re-
issuance.
Pending the receipt of data required by this Registration
Standard, the Agency will reinitiate consultation with FWS
regarding the all registered subspecies of B.
thurinaiensis in regard to endangered species hazard. (This
consultation will also clarify which endangered insects may
be jeopardized by specific strains of B. thurinaiensis.)
No additional labeling is being required at this time.
Rationale - Until the characterization data required by
this Registration Standard are received and reviewed by the
Agency, the presence of atypical insecticidal toxins present
in B. thurincriensis subspecies cannot be determined, i.e. a
coleopteran active toxin present in a kurstaki strain. Data
to be called in by this Standard will enable us to better
define the nontarget host range of B. thurinaiensis
subspecies registered. At that time, the Agency will submit
a request to the Fish and Wildlife Service for a revised
Biological Opinion on B_. thurinaiensis subspecies.
In May 1987, EPA issued PR Notices 87-4 and 87-5
in response to FWS findings that certain pesticides,
including Bacillus thurinaiensis jeopardized the continued
existance of endangered species. These PR Notices directed
registrants to add labeling to their products which referred
users to additional-information that, in turny-explained
limitations on-use-of—the-pesticide within—the range—of-
j eopardized endangered- species.—Subsequent -to issuance of
these PR Notices, EPA identified a number of significant
technical errors and inconsistencies in the information to
which users would have been referred. Therefore, on
January 26, 1988 the Agency issued PR Notice 88-1 which
withdrew PR Notices 87-4 and 87-5 pending the development
of a more focused program to protect endangered species.
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EPA is working to correct these errors prior to
requiring labeling to protect endangered species. When that
program is fully developed, notice of any labeling necessary
to protect endangered species will be issued.
12. The Agency will not place fi. thurinoiensis into Special
Review at this time.
Rationale - Based on the data available to the Agency, £.
thurinaiensis does not meet or exceed any of the risk
criteria specified in 40 CFR 154.7 for Special Review.
13. The Agency will not restrict the use of B_. thurinaiensis
products to certified applicators.
Rationale - There is no indication that B.. thurinqiensis
meets the criteria for restricted use at this time.
14. The characterization data of the product analysis data
requirements will be given priority review.
Rationale - The characterization data are necessary to
determine the applicability of all other data submitted to
support the registration of subject strains.
15. The Agency is not requiring a reentry interval for B.
thurinqiensis.
Rationale - There are no reported toxicological
effects under current use patterns that warrent
establishment of a reentry interval at this time. This
issue will be reevaluated after receipt of the data
requested in this Registration Standard.
16. The Agency will not at this time require protective
clothing for all B. thurinqiensis products.
Rationale - The issue of requirements for protective
clothing will be considered as a generic issue for all
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microbial pesticides and will be addressed at a later date.
17. End-use product storage stability data will be required
specifically to determine the presence or absence of beta-
exotoxin.
Rationale - The Agency is concerned that beta-exotoxin may
be formed in some end use products subsequent to formulation
and that the provisions of 40 CFR 180.1011 may not
adequately prevent the presence of beta-exotoxin in food
use B. thurinaiensis pesticide products.
18. Continuation of Registration - While data gaps are being
filled, currently registered manufacturing-use products and
end-use products containing B. thuringiensis as the active
ingredient may be sold, distributed, formulated, and used,
subject to the terms and conditions specified in this
Standard. Registrants must provide, or agree to develop,
additional data, as specified in the Data Appendices, in
order to avoid suspension of existing registrations.
Rationale - Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) , the Agency may choose not to cancel
or withhold registration if data are missing or are inade-
quate (see FIFRA sections 3(c)(2)(B) and 3(c)(7)). Issuance
of this Standard provides a mechanism for obtaining
necessary data. These data will be reviewed and evaluated,
after which the Agency will determine if additional
regulatory actions are necessary.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain B. thuringiensis. bear required labeling, and
conform to the product composition, acute toxicity limits, and
use pattern requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain B. thuringiensis.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and inert
ingredients which are present in products, as well as impurities
found at greater than 0.1% for chemicals.
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2. Acute Toxicity Limits
The Agency will consider registration of technical grade and
manufacturing-use products containing fi. thurinaiensis provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each product
is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products must be labeled for formulation into end-use products
only for the sites/uses listed in the EPA Compendium of
Acceptable Uses.
D. LABELING
In order to remain in compliance with FIFRA, products must
bear appropriate labeling as specified in 40 CFR 156.10 and this
Standard, or must be revised to conform to those specifications.
Appendix II contains information on label requirements.
No pesticide product containing B. thurinqiensis may be
released for shipment by the registrant after December 30, 1990
unless the product bears an amended label which complies with the
requirements of this Standard.
No pesticide product containing fi. thurinqiensis may be
distributed or sold after December 30, 1991 unless the product
bears an amended label which complies with the requirements of
this Standard.
The Agency is permitting a 2 and 3 year compliance timeframe
for labeling to allow for the submisssion and evaluation of the
characterization data and analytical methodology on which
labeling depends. The following specific information must
appear on the labeling in order for products to remain in
compliance with FIFRA:
1. Ingredient Statement
Under the general labeling requirements of 40
CFR 156.10, every registered pesticide must
have an ingredient statement on its approved
label listing the active ingredient(s) and the
corresponding percentages of each active
ingredient so declared. Pesticide Registration
(PR) Notice 71-6, dated April 9, 1971, required all
preparations of Bt registered by the Agency to
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declare active ingredient percentage based upon
units of potency. The Agency is rescinding PR
Notice 71-6 and is requiring that active ingredient
declarations be based upon percent by weight of
insecticidal toxin(s) present determined by
analytical methods. Strain variety, as well as
percent active ingredient declared for each order of
insects affected must appear on the label.
Although the Agency is rescinding PR Notice
71-6, potency units may still appear on the
label at the registrant's option. In cases where
registrants include potency, potency should appear
below the ingredient statement and be followed by
the statement "Potency units should not be used to
adjust use rates beyond those specified
in the Directions for Use section."
A sample ingredient statement is listed below.
Active Ingredients:
Bacillus thuringiensis subspecies kurstaki
Lepidopteran active toxin(s) ... 2%
Coleopteran active toxin(s) ... 1%
Dipteran active toxin(s) .... 1%
Inert Ingredients: 96%
Potency: 50,000 International Units per
milligram of product or
billion International Units
per pound/quart of this product.
Potency units should not be
used to adjust use rates beyond
those specified in the
Directions for Use section.
2. Use Pattern Statements
All manufacturing-use products must state that they
are intended for formulation into end-use products for acceptable
use patterns. Labeling must specify sites, which are listed in
the EPA Compendium of Acceptable Uses. However, no use may be
included on the label where the registrant fails to agree to
comply with the data requirements in TABLE A for that use
pattern.
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3. Environmental Hazard Statements
The following revised environmental hazard
statement must appear on all MP labels:
Do not discharge effluent containing this
product into lakes, streams, ponds,
estuaries, oceans, or public water unless
this product is specifically identified
and addressed in an NPDES permit. Do not
discharge effluent containing this product
to sewer systems without previously
notifying the sewage treatment plant
authority. For guidance, contact your
State Water Board or Regional Office of
the EPA.
The following environmental hazard statement
must appear on EP labels:
Outdoor Use
Do not contaminate water when disposing of
equipment washwaters.
In addition, EPs that have the following
outdoor uses must bear the corresponding labeling
below:
Forestry Use
Do not apply directly to water or wetlands
(swamps, bogs, marshes, and potholes). Aerial
application-over such sites is permissible only~when
they are not-visible from above the-tree canopy.—Do
not contaminate water when disposing of-equipment
washwaters.
Direct Water Application
Do not apply directly to treated, finished
drinking water reservoirs or drinking water
receptacles.
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Uses Other Than Forestry and Direct
Water Application
Do not apply directly to water or wetlands
(swamps, bogs, marshes, and potholes). Do
not contaminate water when disposing of
equipment washwaters.
V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submittal or changes in composition, labeling or
packaging of the product. The applicable requirements depend on
whether the product is a manufacturing or end use product and
whether the pesticide is the sole active ingredient or one of
multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as the
sole active ingredient are subject to:
1. -The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
2Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to Tables in
that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registration
Standard. Table B lists product-Specific data applicable to
manufacturing-use products. The data in Tables A and B need not
be submitted by an end-use producer who is eligible for the
generic data exemption for that active ingredient.
Table C lists product-specific data applicable to end-use
products. The Agency has decided that, in most cases, it will
not require the submittal of product-specific data for end-use
products at this time. Therefore, most Registration Standards do
not contain a Table C.
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3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with reregistration.
B. Manufacturing use products containing this pesticide as one
of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the sole active
ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the end use
product.
2. If eligible for the generic data exemption3, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data requirements
listed in Table C.
3If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you are
eligible for the generic data exemption for generic data
concerning that active ingredient (Table A) and product-specific
data for the registered manufacturing use product you purchase
(Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient, or
acquire your active ingredient from a firm with ownership in
common with yours, you individually lose the exemption and become
subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end-use
producers lose the exemption, and become subject to the data
requirements in Table A.
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4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of multiple
active ingredients are subject to:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the data
requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice issued
under the authority of FIFRA sec. 3(c)(2)(B). It refers to the
data listed in Table A, which are required to be submitted by
registrants to maintain in effect the regis-tration of products
containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation" of
a product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having
that formulation type. These are classed as generic data, and
are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed in
this Registration Standard.
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require a registrant who qualifies for the femulator's exemption
(FIFRA sec. 3(c)(2)(D) and 40 CFR 152.85) to submit generic data
in response to a DCI notice if the registrant who supplies the
active ingredient in his product is complying with the data
request.
If you are granted a generic data exemption, you rely on the
efforts of other persons to provide the Agency with the required
data, if the registrants who have committed to generate and
submit the required data fail to take appropriate steps to meet
the requirements or are no longer in compliance with this data
requirements notice, the Agency will consider that both they and
you are not in compliance and will normally initiate proceedings
to suspend the registrations of both your product(s) and their
product(s) unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
If you are not now eligible for a generic data exemption,
you may qualify for one if you change your source of supply to a
registered source that does not share ownership in common with
your firm. If you choose to change sources of supply, the
Confidential Statement of Formula must identify the new source(s)
and you must submit a Generic Data Exemption Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not yet
been submitted, any new registration will be conditioned upon the
new registrant's submittal or citation of the required data not
later than the date upon which current registrants of similar
products are required to provide such data. See FIFRA sec.
3(c)(7)(A). If you thereafter fail to comply with the condition
of that registration to provide data, the registration may be
cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed to
evaluate current uses of all products containing this active
ingredient, the uses for which such data are required, and the
dates by which the data must be submitted to the Agency.
D. How to comply with DCI requirements.
Within 90 days of your receipt of this Registration
27
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Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form you
must state which of the following six methods you will use to
comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been formed
which allows you to rely upon the data to be submitted. Such
evidence may be: (1) your letter offering to join in an
agreement and the other registrant's acceptance of your offer,
(2) a written statement by the parties that an agreement exists,
or (3) a written statement by the person who will be submitting
the data that you may rely upon its submittal. The Agency will
also require adequate assurance that the person whom you state
will provide the data is taking appropriate steps to secure it.
The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or a mechanism
to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data Submitter
Number, as part of your 90-day response. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative of
the consortium, with whom EPA will correspond concerning the
data;
c. Identity of the Registration Standard containing the data
requirement;
d. A list of the products affected (from all members of the
consortium); and
e. Identification of the specific data that the consortium
will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to jointly
develop data, but no other registrant has accepted your offer.
You request that EPA not suspend your registration for non-
compliance with the DCI. EPA has determined that, as a general
policy, it will not suspend the registration of a product when
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the registrant has in good faith sought and continues to seek to
enter into a data development/ cost sharing program, but the other
registrants developing the data have refused to accept its offer.
[If your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
a. File with EPA a completed "Certification of Attempt to
Enter into an Agreement with other Registrants for Develop-ment
of Data" (EPA Form 8580-6, enclosed).
b. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must, at a
minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement to be
bound by binding arbitration as provided by FIFRA sec.
3(c) (2)(B) (iii).
The remainder of your offer may not in any way attempt to limit
this commitment. If the other registrant to whom your offer is
made does not accept your offer, and if the other registrant
informs us on a DCI Summary Sheet that he will develop and submit
the data required under the DCI, then you may qualify for this
option. In order for you to avoid suspension under this method,
you may not later withdraw or limit your offer to share in the
burden of developing the data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be 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 submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
4. You request a waiver of the data requirement. If you
believe that a data requirement does not (or should not) apply to
your product or its uses, you must provide EPA with a statement
of the reasons why you believe this is so. Your statement must
address the specific composition or use factors that lead you to
believe that a requirement does not apply. Since the Agency has
carefully considered the composition and uses of pesticide
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products in determining that a data require-ment applies, EPA
does not anticipate that many waivers will be granted. A request
for waiver does not extend the time-frames for developing
required data, and if your waiver request is denied, your
registration may be suspended if you fail to submit the data.
The Agency will respond in writing to your request for a waiver.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required to
submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
£• Registrant Requests Regarding Data Requirements and Agency
Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing. The
original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting the
requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted in
accordance with test standards outlined in the revised Pesticide
Assessment Guidelines Subdivision M, unless other protocol or
standards are approved for use by the Agency in writing. All
testing must be conducted in accordance with applicable Good
Laboratory Practices regulations in 40 CFR Part 160.
The revised Pesticide Assessment Guidelines Subdivision M,
which is referenced in the Data Tables, will shortly be available
at the National Technical Information Service (NTIS), Attn: Order
Desk, 5285 Port Royal Road, Springfield, VA 22161 (tel:
703-487-4650). In. the interim, copies may be obtained from the
Public Information Branch of the Field Operations Division (TS-
787C) within OPP-
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 (Part 158.70). Please
note, however, that certain OECD standards (such as test
duration, selection of test species, and degradate
identification which are environmental fate requirements) are
30
-------
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be be
modified as appropriate so that the data generated by the study
will satisfy the requirements of Part 158. Normally, the Agency
will not extend deadlines for complying with data requirements
when the studies were not conducted in accord with acceptable
standards. The OECD protocols are available from OECD, 1750
Pennsylvania Avenue, N.W., Washington, D.C. 20006.
G. - Procedures for requesting a change in test protocol
If you will generate the required data and plan to use test
procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submittal of the data,
nor will extensions generally be given to conduct studies due to
submittal of inappropriate protocols. The Agency will respond in
writing to your request for protocol approval or change.
H. Procedures for requesting extensions of time
If you think that you will need more time to generate the
data than is allowed by EPA's schedule, you may submit a request
for an extension of time.
EPA will view failure to request an extension before the
data submittal response deadline as a waiver of any future claim
that there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline for
submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you have
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity or
adequacy of funding, since the Agency believes that with proper
planning these can be overcome. The Agency will respond in
writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data, including
31
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the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including, but
n°t limited to, requirements referenced or included in this
Notice or contained in PR Notice 86-5 (issued July 29, 1986).
All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the
submittal requirement.
J« Existing stocks provision upon suspension or cancellation
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision for the registrant
is not consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances. If you
believe that your product will be suspended or cancelled and that
an existing stocks provision should be granted, you have the
burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of 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 or
distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing using
a specific formulated product, and, unlike generic data,
generally support only the registration of that product. All such
data must be submitted by the dates specified in this
Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data are
listed in Table C. As noted earlier, the Agency has decided that
it will not routinely require product-specific data for end use
products at this time. Therefore, Table C may not be contained
in this Registration Standard; if there is no Table C, you are
not required to submit the data at this time.
32
-------
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data) or
VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product and
its uses. General labeling requirements are set out in 40 CFR
156.10 (see Appendix II - LABELING and SUMMARY). In addition,
labeling language specific to products containing this pesticide
is specified in Section IV.D of this Registration Standard.
Responses to this Registration Standard must include draft
labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage in 8-1/2 x
11 files. Draft labeling must indicate the intended colors of
the final label, clear indication of the front panel of the
label, and the intended type sizes of the text.
If you fail to submit revised labeling as required, which
complies with 40 CFR 156.10 and the specific instructions in
Section IV.D., EPA may seek to cancel the registration of your
product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: Bacillus thuringiensis Registration Standard
33
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A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you must
submit for each product subject to this Registration standard:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1), with appropriate attachments.
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 12 months from receipt of this document you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of anv required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed
course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic Data Exemption Statement (EPA Form 8580-3)7
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary Sheet, with
appropriate attachments (EPA Form 8580-1).
b." Confidential Statement of Formula (EPA Form 8570-4)
34
-------
2. Within 12 months of receipt of this document, you must
submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit all generic data, unless you are eligible for the generic
data exemption. If for any reason any test is delayed or aborted
so that the schedule cannot be met, immediately notify the Agency
of the problem, the reasons for the problem, and your proposed
course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B) Summary Sheet,
with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 12 months from receipt of this document you must
submit:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed
course of action.
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
1. Within 90 days from receipt of this document, you must
submit:
35
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a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B) Summary Sheet,
with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 12 months from the receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed
course of action.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted by
that date, no product may be released for shipment by the
producer after July 31, 1988.
36
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I. DATA APPENDICES
-------
TGUIDE-1
GUIDE TO
Tables A, B, and C contain listings of data requirements for
the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to the
pesticide in all products, including data requirements for
which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that apply
only to a manufacturing use product.
Table C contains product-specific data requirements that apply
only to an end use product.
The data tables are generally organized according to 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 out in the revised Pesticide Assessment Guidelines
Subdivision M, which will shortly be available from the National
Technical Information Service, 5285 Prot Royal Road, Springfield,
VA 22161. In the interim, copies may be obtained from the
Public information Branch of the Field Operations Division (TS-
787C) within OPP.
2. Test Substance (Column 2) .This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B « Terrestrial, non-food
C = Aquatic, food
D - Aquatic, non-food
E = Greenhouse, food
37
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TGUIDE-2
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the
table.
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
- EPA has data in its files that completely satisfy this
data requirement. These data may be cited by other
registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data do
not fully satisfy the data requirement. In some cases, the
Agency may possess data on one of two required species or may
possess data on one test substance but not all. The term may
also indicate that the data available to EPA are incomplete.
In this case, when the data are clarified, or additional
details of the testing submitted by the original data
submitter, the data may be determined to be acceptable. If
this is the case, a footnote to the table will usually say
so.
NO - EPA either possesses no data which are sufficient to
fulfill the data requirement, or the data which EPA does
possess are flawed scientifically in a manner that cannot be
remedied by clarification or additional information.
5. Bibliographic citation (Column 5). 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 Appendices
for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This column
indicates whether the data must be submitted to the Agency. If
column 3 indicates that the Agency already has data, this column
will usually indicate NO. If column e indicates that the Agency
has only partial data or no data, this column will usually
indicate YES. In some cases, even though the Agency does not
38
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TGUIDE-3
have the data, EPA will not require its submission because of
the unique characteristics of the chemical; because data on
another chemical can be used to fulfill the data requirement; or
because the data requirement has been waived or reserved. Any
such unusual situations will be explained in a footnote to the
table.
7. Timeframe for submission (Column 7). If column t requires
that data be submitted, this column indicates when the data are
to be submitted, based on the issuance date of the Registration
Standard. The timeframes are generally those established either
as a result of a previous Data Call-In letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
39
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TABLES A AND B
GENERIC AND MANUFACTURING USE PRODUCT DATA REQUIREMENTS FOR BACILLUS THURINGIENSIS
Guideline Citations and
Name of Tests Test I/ Use
For Microbial Pesticides Substance Patterns
§158.170(a)
151A-10
151 A- 11
151A-12
151A-13
151A-15
151A-15
151A-16
151A-17
__
Product Analysis for Microbial Pesticides
Product Identity TGAI/MP All
Manufacturing process " "
Discussion of formation of " "
unintentional ingredients
Analysis of samples " "
Certification of limits MP "
Analytical methods " "
Physical and Chemical Properties:
Color TGAI/MP "
Physical state " "
Odor
Density or specific gravity " "
pH
Stability TGAI "
Storage stability TGAI/MP "
Viscosity MP "
Miscibility
Corrosion characteristics " "
Submit tal of sample TGAI "
Special Testing TGAI "
Does 2/ Biblio- 2/ Must Additional Timeframe
EPA Have
Data?
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
graphic
Citation
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Data be 2/
Submitted?
Yes 3/
Yes
Yes 4/
Yes 5/
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes 6/
Yes 7/
Yes 8/
Yes 9/
Yes 10/
Yes ll/
for
Submissioi
12 months
12 months
12 months
12 months
12 months
12 months
12 months
12 months
12 months
12 months
12 months
12 months
15 months
12 months
12 months
15 months
12 months
N/A 10/
40
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JY A separate study must be conducted on each test substance identified.
_2/ Although product analysis data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and
previously submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
^/ To more adequately identify each strain in each test substance, the following characterization data are particular!
important aspects of 151A-10. Data is to be developed on each B. thuringiensis strain present in the TCAI, except
in the case of 3(h) and 3(i) for which the TGAI is the preferable test substance. References are provided
as examples of appropriate procedures; it is possible that other validated procedures would be appropriate also.
a.) Standard biochemical and morphological testing for Bt as specified in the Volume 2 of Sergey's Manual
of Systematic Bacteriology, 1986 and subsequent editions. Care should be taken to follow media preparation
and testing procedures exactly as they appear in Sergey's Manual of Systematic Bacteriology so
that testing is reproducible.
b.) Flagellar antigen serotyping as described by de Barjac in the following references.
- de Barjac, H. (1981) Identification of H-serotypes of Bacillus thuringiensis, pp. 35-43. In H.W. Burges (ed.)
Microbial control of pest and plant diseases, 1970-1980. Academic Press, London.
- de Barjac, H.; Bonnefor, A (1973) Classification of Bacillus thuringiensis. Entomophaga 18:5-17.
c.) History of the strain including the following.
1. Previous codes or synonyms used to describe the strain.
2. How long the strain has been used in the subject pesticide product.
3. Description of any known changes to have occurred to the strain, i.e., changes that fall under any
of the other characterization data. Intentional strain improvements are to be noted.
4. Storage history of the strain including media used to store and grow the strain.
d.) Standard Gram-positive antibiotic sensitivity patterns using the Kirby-Bauer disc diffusion
method as decribed in the American Society for Microbiology's Manual of Clinical Microbiology.
e.) Insecticidal toxins produced.
f.) Plasmid profiles performed according to the following reference.
- Gonzalez, J.M., Jr.; Carlton, B.C. (1980) Patterns of plasmid DNA in crystalliferous and acrystalliferous
strains of Bacillus thuringiensis. Plasmid 3:92-98.
-------
g.) Description of crystalline proteins.
h.) Data showing which of the following insect orders are affected by the strain.
1) Lepidoptera;
2) Diptera;
3) Hymenoptera;
4) Coleoptera;
5) Orthoptera; and
6) Trichoptera.
i.) A screen for evaluating the pathogenicity and toxicity of the technical grade of the active
ingredient of each currently registered strain of B. thuringiensis is to be done. In general, for the
screen, mice (5 male and 5 females/dose level) are to be injected with a technical grade preparation of
active ingredient containing 106, 107, and 108 units of each B. thuringiensis strain present.
All animals are to be observed frequently during the first day of dosing, and then daily for at least 6
additional days. Animal mortality and time of. death after dosing, and nature, time of onset, and time to
disappearance of all clinical signs of toxicity and illness are to be recorded.
These data are required for each strain in the technical product. Each time a strain is replaced,
modified, or a variant selected, the Agency must be notified via an application for formulation amendment.
At a minimum, the characterization data must be submitted for modified strains or selected variants.
Unplannned variation is to be minimized by use of seed derived from aliquots of a large initial batch of
the strain on which the human and environmental studies were conducted. Registrants should periodically test
subsequent aliquot producing batches, grown from an aliquot of the original aliquot producing batch, to assure that
strain variation has not taken place. Such variation would include change in host range, quantity (unrelated to
culture conditions) and types of toxins produced, etc.
4/ This discussion should include the potential for alteration of the active strain(s) during fermentation or seed
~~ aliquot production via such processes as transconjugation by contaminating B. thuringiensis strains (perhaps present
as carry-over from an earlier batch) or other species. If the potential exists, a quality control step should be
introduced to monitor such changes.
42
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V The insecticidal toxins produced by each strain are to be quantified via an analytical method
such as SDS-polyacrylamide gel electrophoresis (SDS-PAGE), enzyme-linked immunosorbent assay (ELISA), or
high pressure liquid chromatography (HPLC) for the purpose of reporting percent active ingredient on the CSF
and the label.
6/ The storage stability study must include, but not be limited to, the detection of beta-exotoxin during storage of th
MP.
7/ Required for liquid formulations only.
8/ Required for emulsiftable liquid formulations only.
¥/ Required only when packaged in metal, plastic, or -paper containers.
10/ A pure culture of each strain currently marketed (or soon to be marketed) must be deposited in a recognized culture
collection. If a strain is modified, it will be considered a new strain and must be redeposited. Registrants will
be notified in the event an Agency-approved/operated culture collection is selected for deposit of strains.
Registrants are required to submit verification of which culture collection the strain is deposited in.
ll/ Each production batch of the TGAI must be screened for the presence of pathogenic organisms using acceptable
microbiological techniques. In addition, all other requirements of 40 CFR 180.1011 are to be performed on each
production batch of the TGAI for all B. thuringiensis products, nonfood uses as well as food uses.
These data are not to be submitted to the Agency, but must be made available to the Agency upon
request. Registrants must notify the Agency of the presence of human pathogens immediately upon
discovery under Section 6(a)(2) of FIFRA. Approval must be granted by the Agency before pathogen contaminated
batches may be marketed.
43
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TABLE A
GENERIC DATA REQUIREMENTS FOR BACILLUS THURINGIENSIS
Guideline Citations and
Name of Tests Test
For Microbial Pesticides Substance
Must Additional Timeframe
Use Does EPA I/ Bibliographic 2/ Data be for
Patterns Have Data? Citation Submitted? Submission
§158.170(c) Toxiocology 3/
152A-10 Acute oral tox/path
152A-12 Acute pulmonary
tox/path
152A-13 Acute intravenous
tox/path
152A-15 Hypersensitivity
incidents
TGAI
1GAI
TGAI
All
Yes
Yes
Yes
Yes
12 months 4/
12 months 4/
12 months 4/
12 months 4/
I/ Until the Agency can determine that the strain of Bacillus thuringiensis used in testing is
sufficiently similar to the strain currently used in the registered pesticide product, the
Agency reserves judgement on whether or not data on file is acceptable.
2/ Bibliographic citations are reserved until studies are confirmed as acceptable.
2/ EPA has revised its data requirements for toxicology testing for microbial pesticides to reflect the scientific
advances made in testing methodology, to focus more clearly on the microbial component of the product,
and to reflect EPA's experience in regulating these microbial pesticides.
4/ The data that are required must be submitted within the timeframe indicated in the data table. However, if
a company wishes to share data between different strains or wishes to utilize data already submitted to the
Agency, then the timeframe for submissions will begin once the Agency has determined whether sharing of data
is warranted or whether testing performed prior to this Registration Standard was done on strains similar
enough to strains currently in registered pesticide products.
AA
-------
GENERIC DATA REQUIREMENTS FOR BACILLUS .THURINGIQJSIS
Guideline Citations and
Name of Tests Test Use I/
For Microbial Pesticides Substance Patterns
Does EPA 2/
Have Data?
Bibliographic 3/
Citation
Must Additional
Data be
Submitted?
§158.170(d) Nontarget Organisms; For Microbial Pesticides
Avian and Mammalian Testing
154A-16 Avian oral
154A-17 Avian respiratory
pathogenicity
154A-18 Wild mammal
154A-25 Terrestrial wildlife
& aquatic organism
154A-26 Avian pathogenicity/
reproduction test
154A-33 Simulated & actual
field tests-
birds & mammals
Aquatic Organism Testing
154A-19 Freshwater fish
154A-20 Freshwater aquatic
invertebrate
154A-21 Estuarine & marine
animal
TGAI A/B/C/D/G/H
Yes
Yes
No
Reserved 4/
Reserved 4/
No
TGAI A/B/C/D/G/H
Yes
Yes
Yes
Timeframe
for
Submissior
12 months
12 months
12 months
12 months
15 months
I/ Because of the minimal exposure on nontarget species to Bacillus thuringiensis via Indoor and
Greenhouse use patterns, the Agency has determined that nontarget organism testing for these use patterns is not
required.
2/ Until the Agency can determine that the strain of B. thuringiensis used in testing is sufficiently
similar to the strain currently used in the registered pesticide product, the Agency reserves judgement on
whether or not data on file is acceptable
3/ Bibliographic citations are reserved until studies are confirmed as acceptable.
\/ Requirement reserved pending results of Tier I testing.
5/ The data that are required must be submitted within the timeframe indicated in the data table. However, if
~ a company wishes to share data between different strains or wishes to utilize data already submitted to the
Agency, then the timeframe for submissions will begin once the Agency has determined whether sharing of data
is warranted or whether testing performed prior to this Registration Standard was done on strains similar
enough to strains currently in registered pesticide products.
BEST AVAILABLE COPY
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TABLE A
GENERIC DATA REQUIREMENTS FOR BACILLUS THURINGIENSIS
Guideline Citations and
Name of Tests Test Use _!/
For Microbial Pesticides Substance Patterns
Does EPA 2/
Have Data?
Must Additional Timeframe
Bibliographic 3/ Data be for
Citation Submitted? Submission
§158.170(d) Nontarget Organisms: For Microbial Pesticides cont'd
A/B/C/D/G/H
Aquatic Organism Testing cont'd
154A-25 Terrestrial wildlife TCAI
& aquatic organism
154A-27 Definitive aquatic "
animal
154A-28 Aquatic embryo & life "
cycle
154A-29 Aquatic ecosystem
154A-34 Simulated & actual
field tests-
aquatic organisms
n
TEP
Reserved 4/
Reserved 4/
Reserved 4/
Reserved 4/
Reserved t/
Nontarget Plant Testing
154A-22 Plant studies
Nontarget Insect Testing
154A-23 Nontarget insects
154A-24 Honeybee testing
TEP
TGAI
n
Yes
Yes
Yes
12 months V
12 months 5/
12 months 5/
I/ Because of the minimal exposure on nontarget species to B. t^ringj.ensis via Indoor and Greenhouse
use patterns, the Agency has determined that nontarget organism testing for these use patterns is not required.
2/ Until the Agency can determine that the strain of B. thuringiensis used in testing is sufficiently similar to the
~~ strain currently used in the registered pesticide product, the Agency reserves judgement on whether or not data on
file is acceptable.
3/ Bibliographic citations are reserved until studies are confirmed as acceptable.
V Requirement reserved pending results of Tier I testing.
5/ The data that are required must be submitted within the timeframe indicated in the data table. However, if
~ a company wishes to share data between different strains or wishes to utilize data already submitted to the
Agency, then the timeframe for submissions will begin once the Agency has determined whether sharing of data
is warranted or whether testing performed prior to this Registration Standard was done on strains
similar enough to strains currently in registered pesticide products.
46
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TABLE A
GENERIC DATA REQUIREMENTS FCR BACILLUS THURINGIENSIS
Guideline Citations and
Name of Tests
For Microbial Pesticides
Test
Substance
Use
Patterns
Does Biblio-
EPA Have graphic
Data? Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submissioi
§158.170(b) Microbial Pesticide Residue Analysis I/ Reserved I/
I/ Residue data requirements apply when Tier II or Tier III toxicology data are triggered by
the acute oral, acute pulmonary, or acute intravenous studies as required in the Toxicology Table A of this
Registration Standard. See the revised Subdivision M for details concerning what results trigger
Tier II or Tier III testing.
47
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TABLE A
GENERIC DATA REQUIREMENTS FOR BACILLUS THURINGIENSIS
Guideline Citations and Does Biblio- Must Additional Timefrarm
Name of Tests Test Use EPA Have graphic Data be for
For Microbial Pesticides Substance Patterns Data? Citation Submitted? Submissic
§158.170(d) Environmental Fate for Microbial Pesticides I/ Reserved I/
I/ Environmental Fate data requirements apply when Tier II or Tier III testing is triggered by
the results of Tier I testing required in the Nontarget Organism Table A of this Registration Standard. See
revised Pesticide Assessment Guidelines Subdivision M for details concerning what results trigger Tier II or Tier II!
testing.
48
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TABLE C
END USE PRODUCT DATA REQUIREMENTS FOR BACILLUS THURlNGIBjSI^gl
Guideline Citations and
Name of Tests
For Microbial Pesticides
Test
Substance
Use
Patterns
Does
EPA Have
Data?
Biblio-
graphic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.170(a) Product Analysis for Hicrobial Pesticidesl
151A-26 Physical and Chemical Properties:
Storage stability EP ALL NO N/A Yes 2/ 15 months
I/ Those end use products that do not use a manufacturing use product in their formulation must be supported by the
product chemistry data requirements listed in Tables A and B.
2/ A storage stability study determining concentrations of beta-exotoxin must be determined in each EP
immediately prior to packaging and 6 months later (unless a sooner or later interval can be demonstrated to be a
more typical storage period). The fly larva bioassay as well as a specific confirmatory method, such as HPLC, must
both be used for analysis. The Agency suspects that beta-exotoxin may be formed in certain end-use
products subsequent to formulation.
49
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II. LABELING APPENDICES
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item i. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will not
be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address of
the registrant or distributor is required on the label. The
name and address should preferably be located at the bottom of
the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is required
on all labels or on the container of the pesticide. The
preferred location is the bottom of the front panel immediately
above the company name and address, or at the end of the label
test. The net contents must be expressed in the largest
suitable unit, e.g., "1 pound 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number
and the required identifying phrase must not appear in such a
manner as to suggest or imply recommendation or endorsement of
the product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final
establishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of the
package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or
container. [40 CFR 156.10(f)]
50
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SUMMARY-2
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR
156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The Statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.
[40 CFR 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement.
[40CFR 156.10(h)(1)(1)].
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the label
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word POISON.
[40 CFR 156.10(h)(1)(i)].
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A Statement Of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. [40 CFR I56.l0(h)(l)(iii)]
-------
SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 156.10(h)(l)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that
these statements be surrounded by a block outline. Each of the
three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h)(2)(ii) ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on
the results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is used
in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA see. 3(d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
52
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SUMMARY-4
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. if they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During the
Agency's review of your application, your proposed
classification determination will be evaluated in accordance
with the provisions of 40 CFR 162.11(c). You will be notified
of the Agency's classification decision.
Classification Labeling Reqnirements
If your product has been classified for restricted use, the
following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 156.10(h)(1)(iv).
b. Directly below this statement on the front
panel, a summary statement of the terms of
restriction must appear (including the reasons for
restriction if specified in Section I). If use is
restricted to certified applicators, the following
statement is required: "For retail sale to and use
only by Certified Applicators or persons under
their direct supervision and only for those uses
covered by the Certified Applicator's
Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified for
restricted use, and some are unclassified, several courses of
action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses
that are unrestricted, but you may not distinguish
them on the label as being unrestricted.
53
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SUMMARY-5
b. You may delete all restricted uses from your
label and submit draft labeling bearing only
unrestricted uses.
c. You may "split" your registration, i.e.,
register two separate products with identical
formulations, one bearing only unrestricted uses,
and the other bearing restricted uses. To do so,
submit two applications for reregistration, each
containing all forms and necessary labels. Both
applications should be submitted simultaneously.
Note that the products will be assigned separate
registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling." This
statement appears at the beginning of the directions for use,
directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the
label. Additional worker protection statements may be required
in accordance with PR Notice 83-2, March 29. 1983.
54
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SUMMARY-6
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the
directions for use. This heading must be set in the same type
sizes as required for the child hazard warning. Refer to
Appendix II, STOR, PEST/DIS, and CONT/DIS to determine the
storage and disposal instructions appropriate for your
products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue or to supervise the use of the
pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. [40
CFR 156.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and
submitted for review.
55
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SUMMARY-7
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
7ARFT, ELFMEWT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON T.ARFT,.
PREFERRED
Center front
nanel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel
immediately
before or
following
Rea. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
-
Immediately
below child
hazard
wamincf
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . . ,"
"Distributed by . . . ." etc.
May be in metric units in addition to
U.S. units.
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
56
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SUMMARY-8
TARET.TM1 REQUIREMENTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
7C
7D
7E
8
8A
8B
LABEL FT.FWFMT
Skull & cross-
bones and word
POISCN (in red)
-
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Envi ronmental
hazards
APPLICABILITY
OF REOJIREMEMT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicitv
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front canel
All products
All products
in Categories
I, II, and III
—
All products
PLACEMENT
REOJIRED
Front panel
Category I;
Front panel
unless refer-
ral statement
is used.
Others;
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
1
ON LABEL
PREFERRED
Both in close
proximity to
signal word
Front panel
for all
Top or side
of back panel
preceding
directions
for use
Same as above
- -
Same as above
COMMENTS
Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where aoolicable.
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SUMMARY-9
LABELING REQUIREMENTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
8C
9A
9B
10A
10B
TARFT. TTT.FMPWT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
IOC Directions
! for use
i APPLICABILITY
! OF REQUIREMENT
JAI1 pressurized
j products, others
{with flash
! points under
!l50QF
JA11 restricted
j products
i
i
JMl products
i
i
i
i
i
i
JPR Notice 83-2
jor as determined
bv the Aoencv
'All products
i
i
i
i
i
i
i
i
i
JAI1 products
i
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFFpRFn
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
, .._.
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
sional word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
58
-------
Cffi.
•Ml l.nhrllnR i
(a I Grnfrnl-tl) Conlrnlt of Ilif
hi-nr .1 l.ilirl riiiil.tlnliilt HIP Illinium
Hun .'.(iiTlllnl l»v the Act nml ltii< rri:n-
Hllini^ In I tils r.irl. 'I'lir rnnlcnl.i nl .1
l.ihi-l MII»| show rlrnily nml promt-
iii-Mily ihr lf)llowlii«:
ill I hi* ii.-imr. Inniul. or Irnilrmnrk
iimlrr which the product la sold a* |>rc-
-------
lion:
in par.iKr.iph (bi of this sec-
ui) The name anil address of (he
produriT. registrant, or person for
whom produced as prescribed in para-
graph (el o( this seel ion:
i tii> The net contents as prescribed
in paragraph (dl of this section;
i iv i The . product rcgisl ration
number as prescribed in paragraph a pesticide or a device declared
siibiecl lo the Act pursuant to
| 162.15. Is mlsbranded II Its labeling is
false or misleading In any particular
Including both pcsilcld.il and non pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute mishrandmg include:
til A false or misleading statement
concerning the composition ol the
product:
till A false or misleading statement
concerning the ellcclncncss of the
pioduct as a pesticide or deuce:
tilll A false or misleading statement
about the value ol I he product lor
pnrpo-.cs other than as a pesticide or
lll-VICf.
i iv i A lalse or misleading comparison
uilh other pesticides or devices:
«vt Any statement directly or Indl-
rrcilv implying that the pesticide or
dev ice Is recommended or endorsed by
any agency ul the Federal Govern-
ment ;
tvli The name of a pesticide which •
contains two or more principal active
initrciliritis If the name suggests one
or more lint not all such principal
ad It e ingredients even though (he
names of the other Ingredients are
Staled elsewhere in the labeling:
lull A true statement used in such a
»ay as lo give a false or misleading im-
pression lo the purchaser:
Ivilli Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
lixl Claims as lo the salcty of the
pesticide or its ingredients, including
statements such as "safe." '•nonpoisoii-
ous." "noiiinliirious." "harmless" or
"nonioxic lo humans and pels" with
or without such a qualifying phrase as
"when used as directed": and
txi Non numerical and /or compara-
tive statements on the safely of the
product, including but not limited lo:
lAl "Contains all natural ingredi-
ents";
till "Among the least toxic chemi-
cals known"
ICI "Pollullon approved"
161 Final pnnfcd labeling. (II Except
as provided In paragraph I a it 6 It III of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
dralt label lexis have been provision-
ally accepted by the Agency.
till Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
, tbl Name, brand, or trailemitrk. (I)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on the front panel ol the
label. ' -
(21 No name, brand, or trader i
may appear on the label which:
(ii Is false or misleading, or
till lias not been approved by
Administrator through registration n
supplemental registration as an i
lional name pursuant to 1 162 6(h)
(ci Name and address of prodi
regislranl. or person for whom
duced. An unqualified name and
dress given on the label shall be
sidered as the name and address of
producer. If the registrant's name ,
pears oil the label and the regisl rat b
not the producer, or if the name of Hi
person for whom the pesticide w.i
produced appears on the label, it inns
be qualified by appropriate wordin
such as "Packed for * * *." "Dislrihul
ed by • * V or "Sold by to sho
I hat the name Is not that of the prij
ducer.
(dl Net weight or measure of con
tents. (II The net weight or measur
of content shall be exclusive of wrap
pers or other materials and shall b
the average content unless explicit)
slated as a minimum quantity.
(21 If the pesticide is a liquid. Ih
net content statement shall be u
terms of liquid measure at 68* F<20'('
and shall be expressed in convention.!
American units of fluid ounces, pints
quarts, and gallons.
(31 If the pesticide Is solid or semi
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be In terms iu
weight expressed as avolrdupoll
pounds and ounces. 4
Ml In all cases, net content shall tie'
stated In terms of the largest suitable
units. I.e., "I pound 10 ounces" rather
than "26 ounces."
(51 In addition lo the required units
specified, net content may be ex
pressed in metric units.
(6) Variation above minimum co
tent or around an average Is permiss
ble only lo the extent that It repn
sents deviation unavoidable In good
manufacturing practice. Variation
below a staled minimum Is not permit
led. In no case shall the average con-
tent of the packages In a shipment full
below the slated average content.
(el Product registration number.
The registration number assigned I
the pesticide product at the time '
BEST AVAILABLE COPY
-------
roKisI ration shall appear on I he label.
preceded by the phra.se "EPA llegis-
Iratiiin No.." or the phrase "EPA Reg.
No." The registration number shall be
set In type of a size and style similar to
other print on that part of the label
on which il appears ami shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear In such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
ill Producing esfaofishmrnfj rrp<»-
IMI/IOH mi in her. The producing estab-
lishment rci: 1st rat ion number preced-
ed by the phrase "KPA Ksl.". nl the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
paitkaue if the EPA establishment reg-
isiiaiHin number pn the immediate
rout .imer cannot be clearly read
through such wrapper or container.
IK) Ingredient statement—(I) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percent axe by weight of
eh active ingredient. ||lc total per-
n-iiiace by weiKhi of .ill inert ingrcdl-
enls: and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active Ingredi-
ents" and the inert Ingredients by the
term "Inert ingredients." or the singu-
lar forms of these terms when appro-
priate. Ilolh terms'shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" Is
not required for pesticides which con-
tain 100 percent active Ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
lerm "analysis" shall not be used as a
heading for the ingredient statement.
12) Post/ion o/ ingredient statement.
'•> The ingredient statement Is nor-
mally required on the front panel of
I lie label. If there Is an outside con-
tainer or wrapper through which the
iiiRredirnt statement cannot be clearly
ri'"d. Ilu> ingredient statement must
appear on such outside container
or wrapper. If the size or form of the
package makes II impracticable to
place the Ingredient statement on the
front panel of the label, permission
may be granted lor the ingredient
statement to appear elsewhere.
(Ill The text of the ingredient state-
ment must run parallel with other
te.xl on the panel on which it appears.
and must be clearly diNitnguish.thle
from and must not be placed in the
body of other text.
431 Names to bt used in inornlient
statement. The name used for earh In-
gredient shall be the aireplcd
common name, if there 1% one. lol
lowed by the chemical name The
common name may be used alone only
If it is well known. If no common name
, has been established, the chemical
name alone shall be used. In no case
will the use of a iradrm.uk or propne
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of section -'5».
HI Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight lo-vteiKhl.
The sum of percentages of the art lie
and the inert Ingredients shall br 100.
Percentages shall not be expressed bv
a range of values such as "22 2V..' If
the uses of the pesticide product are
expressed as weight of acme ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide lnrniiil.ilinn
shall also appear in the mgiedienl
statement.
151 Accuracy o/ tinted percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the taluc staled for
each active ingredient shall be the
lowest percentage which may be
present.
(til Deterioration Pesticide;! which
change In chemical composition sig-
nificantly must meet the following la-
beling requirements:
ill In cases where It Is determined
that a pesticide formulation changes
chemical composition significantly.
the pimliict must bear the following
statement In a prominent position on
Hie label: "Not for sale or use after
Idatel
IIII The product must meet all label
claims up to the expiration time indi-
cated on the label.
Ill Inert ingredients. The Adminis-
trator may requite the name of any
Inert liiKredlenllsl lo be listed In the
Ingredient statement tf he determines
that such Ingredlcnlisl may pose a
hazard to man or the environment.
(hi Wiirntnqs and precautionary
statements Required warnings ami
precautionary statements concerning
the general areas oi lo.xlcoloi:n"il
h.i/ard including hazard lo children.
cnviionmenlal hazaid. and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below.
(II Acquired front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
Is determined by the Toxicily Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
ha/.nrd shown by any of the Indicators
in the table below:
I
OaMO..
MtaiahonlC.
I Fiom M IMv MO mpt* Fiom MO tin, MOO »«,/ ' Gwatt* man MOO wo,/
I '• ! "•
I Fiom 2 inni 2 mq'Mw . Fiom 2 Hm 2O mqiuti . C>*aw> man 20 nqiUat
' Up 10 i"d
-------
slalcinenl of prnrlir.il treatment (first
iiiil or iilhcri shall appear on the front
panel of the label of .ill pesticides fall-
ing into ToxirHy Category I on the
h.i.sis of or.il. inhalation or dermal lox-
Irily. The Agency may. however,
pi-unit reasonable variations In the
placement of the statement nt practi-
cal treatment is some reference snrli
as "See siatcntcnt of prarllcal treat-
ment on bark panel" appears on the
linnl panel near I lie wnnl "Poison"
aii*l HII- skull aiul crnsshoiies.
lM» Dlhi-r tntn-tlti cnlranries. Tlie
statement tif practical treatment Is not
iciinircd mi |In- Iriinl panel except as
ilcsci ll.rtl in p;ii :ii:i :i|>lt I h » I HIIIM A) of
tins section. Tin- applicant may. how-
ctcr. incluile such :i (mm panel state-
ment at Ins option. Statements of
practical treatment are. however. re-
qiiued elsewhere on I he label In
accord \\ilh parai:iapli (I|H2) of this
MMimii if they do not appear on the
fiiinl panel.
d\» riarfinrnt" nnil prominence. All
(lie r-ipnre front panel warning stale-
nicnl.i shall he itronpeil together on
ihe label, ami shall appear \tilh stitll-
riciil prominence relative to other
limit panel text anM .nhMhon. o> dttnul WMily
Siia ol labri html p.tnH m taunt
•nclirt
1 And imrtf*
AKn.f S In 10
Abo.a 10 10 II
Abo.* 15 lo M
o»« m
<*ntn til
cAO'iatt
*»ftl rul
• nl >»im ai
cniWirn
10 '
*• i
10
• 7
t2) Other irtjtntrti tiarninos nnil r»'-
rnHlioimrt/ triirrmenM. 'I IIP •.\aininrs
and piccautimiai v statement; as re-
quired helinv shall appear foi;cihrr on
the label under the r;eiier.i| heading
••Piccaullonaiv .Statements • .iIM|
under appiopriaie siil>lir:iilini:s ol
"lla/.ard to Humans and Domestic Ani-
mals." ••F;mironmenial Hazard" and
-Physical or Chemical Hazard •
(IV Uninnt In Humans iintt domestic
animals. «AI Where a ha/ard exists to
humans or domestic animals, precau-
tionary statements are requited null
cnlini! the paiticiilar ha/anl. the
routetsl ol exposure and the precau-
tions lo be taken to a\i>ul arridem.
In Miry or damaite. 'I'he precautionary
paraitraph shall he immediately pie-
ceded by ihe appropriate ha/.ard sicnal
word.
(Ill Ihe follouini! table depicts t«pi-
ca! precautionary statements. These
statements must be modilted or ex-
panded lo reflect specific hazards.
Sk« •urn r»m>n« i<«tnKji m I»IM 4 <»>>o~m
OVtftf | I | Aup*OfVi.tlv t^fl J4 »IW^n^nl imiMpfl |
tr»niM|n rha %im| Or> not b>*aiho vapoft Io\i9l of I on ^ftm o» on C*OMM^ Httmitri 4 i*jiiioAMt tAo
»u>», mill On not 9rl m r,n on MM of on j
M.Kf l,tf 4 nw
I comaci
IX'IIP l«^
INo p*«c.luMmafy ^Uletnemt
Idufl O>
m
in cxia ot
! Cnnllcl •nfliftMIrl* Itutn f>»Vf Of tkm *
i •»«!•€ G#l nn^ca* .tiienfcon 4 .ftfaiHin
lilt f«i iM>ii»ie>ii*(i/ htiznnls. Where a quiied slalliiR Ihe naluie 0| Ihe
li.i/anl exists lo nun taii:el organisms ha/.aid and the appmiiriale pircau-
'•xcliidini; liiiiiians and domestie ani- lions to a«oid potential accident.
Minis, piecaiilionary statements are re- liinuy or damage. Examiiles ol the
hazard statements and the circum-
stances under which they are required
follow:
•' 1.1 *<•>• K • Kainoac* al | f •
i«« MM>I«. and i« Oa not uaa o> t*»a nan i
••m* Oa not pvnciwa a> Wmatalo u»«a«M».
ian»« aUi»a IV F may cau*a butkng.
(•I Honmt ttmmto CdHiaMtm
M o> own. 70- f .
TO' r ami not OM>
Abort •»' f an* not ox»
Oa not ino oi *»>• no* haal ot opon Ran*
DlrecMon* for f/ie-tl) Cltntrat
rrquirrmenfi— The Administrator determines
that It Is not necessary for such direc-
tions lo appear on the label. "> '
(III) Exceptions to requirement fof
direction for iue-(A) Detailed dlrec
-------
lions Int use in.iv bo omitted from la-
beling of P«'st iridi-s which are intended
lor use only by manufacturers of prod-
ucts ollHT than pesticide products in
their regular manufacturing processes.
provided that:
if) The label clearly shows that the
product is intended for use only In
ni.iriiifart urine processes and specifies
the typeis) nf products Involved.
I?) Adequate Information such as
technical data sheets or bulletins. Is
axailable to the trade specifying the
type of product involved and IU
proper use In manufacturing process-
es.
The product will not come into
(lie hands of the general public except
alter incorporation into finished prod-
ucts: and
The target pestts) associated
with each site.
(vi The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and typeist of application ap-
paratus or equipment required.
(vii) The frequency and tuning of ap-
plic.Tiions necessary lo obtain effective
results without causing unreasonable
adverse elfects on the environment.
(viiil Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFIl Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165 These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type nf the same minimum sl7.es
as required for the child hazard warn-
ing. (See Table in 4 162 lOdiH I Mivi)
(x) Any limit at ions or restrictions on
use required lo prevent unreasonable.
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops
(ID Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
In or adtacent to certain areas.
(D) (Reserved!
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who Is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s). bolh of these uses may appear
on a product labeled for restricted use.
Such products shall be subject lo the
provisions of | 162.101JM 2).
(I) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words 'General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
Of mlsbrandlng.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
siflcation on the front panel
scribed below:
(I) Front panel statement of rt
fit use classification. (A) At the
the front panel of the label, set I
of the same minimum sizes as re
for human hazard signal word:
table In § 162 10( I Klv». and ai
Ing with sufficient prominence r«:
to other text and graphic mater s
the front panel to make it unllk
be overlooked under customary <:
lions of purchase and use. the •
menl "Restricted Use Pesticide" .
appear.
(B) Directly below this statement <
the front panel, a summary stalemei
of the terms of restriction Imposed
a precondition to registration sh;
appear. If use is restricted to certlfh
applicators, the following statement
required: "For retail sale to and u.<
only by Certified Applicators or pe
sons under their direct supervision an
only for those uses covered by the Cei
tilled Applicator's certification." I
however, other regulatory restrictlor
arc imposed, the Administrator wl
define the appropriate wording for th
terms of restriction by regulation
(k) Advertising. (ReservedI
140 PR 28268. July 3. 1975: 40 PR 37319
AUR. I. 1975: 40 PR 36571. AUR. 21. 1975.
amended at 43 PR 5786. Feb. 9. 19781
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PHYSICAL-CHEMICAL
Criteria
I. pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable, keep away
from heat and open flame,
Do not use or store near
heat and open flame.
None required.
64
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of the
label under the heading STORAGE AND DISPOSAL. Products intended
solely for domestic use need not include the heading "STORAGE AND
DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure while
opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
65
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
l. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or feed
by storage or disposal."
2. Except those products intended solely for domestic use, the
labels of all products that contain active ingredients that are
Acute Hazardous Wastes or are assigned to Toxicity Category I on
the basis of oral or dermal toxicity, or Toxicity Category I or
II on the basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions, contact
your State Pesticide or Environmental control Agency or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart G for a hazardous waste must bear the following pesticide
disposal' statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your state
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original container
in several layers of newspaper and discard in trash."
66
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container dii.
instructions appropriate to the type of container.
1- Domestic use products must bear one of the follo».
container disposal statements:
Container Type
Statement
(Non-aerosol products [Do not reuse container (bottle, can, jar).
!(bottles, cans, iars)!Rinse thoroughly before discarding in trash.
!Non-aerosol products
!(bags)
JDo not reuse bag.
Discard bag in trash.
[Aerosol products
[Replace cap and discard containers in
!trash. Do not incinerate or puncture.
2.
All other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
'Triple rinse (or equivalent). Then offer
J f or recycling or reconditioning, or puncture
jand dispose of in a sanitary landfill, or by
j other procedures approved by state and local
[authorities.
[Triple rinse (or equivalent). Then offer
[for recycling or reconditioning, or puncture
[and dispose of in a sanitary landfill, or
[incineration, or, if allowed by state and
[local authorities, by burning. If burned,
Istay out of smoke.
[Triple rinse (or equivalent). Then dispose
[of in a sanitary landfill or by other
[approved state and local procedures.
[Completely empty liner by shaking and
[tapping sides and bottom to loosen clinging
[particles. Empty residue into application
[equipment. Then dispose of liner in a
[sanitary landfill or by incineration if
[allowed by state and local authorities.
[If drum is contaminated and cannot be
[reused^-/, dispose of in the same manner.
[Completely empty bag into application
[equipment. Then dispose of empty bag in
[a sanitary landfill or by incineration,
',or, if allowed by State and local
[authorities, by burning. If burned, stay
[out of smoke.
[Return empty cylinder for reuse (or
[similar wordina).
I *" J • _-_-- ~mr — -~! I ^ ,».-.. ^ J -fr T. V «. ^^J»^l f T
V Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
67
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III. FORMS APPENDICES
-------
EPA Form 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3ICH2H6I SUMMARY SHEET
E'A REClSTftATiO* NO
'ROOUCT NAME
APPLICANT $ NAME
OATC GUIDANCE DOCUMENT ISSUED
With ruetct to tt>« rtguirtmtnt to mibmil "|t«»fie"" fit* mtpOMO* bt tM FIFHA OKtion 3(C)(2)(6I nettM conuintd m |h« rtfcfcncrd
Guidinci Document. I «m mponding in itit following mtnntr:
O I. I will lubmrt 0ITI in • timttf minntr to •liftf the fellewin| rtquifimfntt H ff>« tttl pree«tfum I will «• flt».r« * (ollowing dm
nquinmtnti Thi ttm. mfl «nT riQuirtd preiecod. will b« lubminid l« EPA by:
NAME OF OTME<* REGISTRANT ~~~~~~
Attach list of data requirements
. I »neiOB i tempiittd "Ctnifejjion of Animpi to Emir Into *n Agrnmint with Otttir Rtt>nrinu for Dr»iiepnyM el Oiu" with
rupic: to tn« following dm nqu'rtmmtt:
O 4. I rtQuet tnit yew imtnd my rtjirtrnion by 0°*«il«0lf to cpliMnti for ntw preeutu):
C S. I nguOT volumvy cinttllttien of thi rtginntien of thii produa (Thu option it nei tvtUioU B ipplcjnu for iw* prodgcu.1
AUTHORIZED REPMCSCNTATlVE
SIGNATURE
DATE
68
BEST AVAILABLE COPY
-------
OMB Approval No. 2070-00-
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I nave read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the product
contains the active ingredient solely as the result of the incorporation into the product
of another product which contains that active ingredient, which is registered under FIFRA
Section 3, and which is purchased by us from another producer.
(3) An accurate Confidental Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company name,
registration number, and product name, the source of the subject active ingredient in my
firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source (s) of the above named active ingredient in my product (s) is/are
and their registration number (s) is/are .
My firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of roy firm, that if at any time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings made
in this Statement, my firm's product's registration may be suspended under FIFRA Section
3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant(s) who have committed to generate and submit the
required data fail to take appropriate steps to meet requirements or are no longer in
compliance with this Notice's data requirements, the Agency will consider that both they
and my firm are not in compliance and will normally initiate proceedings to suspend the
registrations of my firm's product (s) and their product (s), unless my firm commits to
submit and submits the required data in the specified time frame. I understand that, in
such cases, the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:.
(Signature
Dated:
(Typed)
EPA Form 8570-J
69
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SEPA
-
Registration
Guideline No.
Sec. 158.120
Product
Chemistry
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-9
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
Toxicology
81-1
81-2
81-3
81-4
81-5
81-6
US Environmental Protection Agency Registration Standard for.
Washington, DC 20460
Product Specific
Data Reoort
Name of Test
Identity of Ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-density, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
PH
Stability
Oxidizing/reducing reaction
Rammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toxicity, rat
Acute dermal toxicity, rabbit
Acute inhalation toxicity, rat
Primary eye irritation, rabbit
Primary dermal irritation
Dermal sensitization
Testing not
required for my
product listed
above
(Check below)
EPA Registration Number
I am complying with
Data Requirements by -
Citing MR ID No.
Submitting Data
(Attached)
(Check below)
Form Approved
OMB #20704057
Expires 11-30-89
(For EPA Use
Only)
Accession
numbers
assiqned
Certification
I certify 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 f ne or imprisonment or both under applicable law.
Typed Name and Title
Signature
Date
EPA Form 8580-4 (Rev. 5-88) previous edition is obsolete.
70
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EPA Form 8580-6
OMB Approval NO. 2070-0057
Expires 11/30/89
(To qu»//f>.
fourHimt)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I wn duly •utnorized to represent the following firmdl who are tubpct to the require-
ment* of • Notice under FIFRA Section 3le)(2)(BI conuined in • Guidmo* Document
10 tubmit d*u concerning the •ctivc ingredient:
GUIDANCE OOCUMCMT CATC
ACTIVE IMGMEDIEMT
NAME Of PIMM
EPA COMPANY NUMBER
(Thii firm or group
(
DATE DUE
1
2. My firm « willin
into «n •ere«n>«i
itami or tliu:
BJED EPA 540./BS-89-023
Guidance for the reregistration of"
wood preservative pesticide prod--
ducts contaiJiing chromated and no
chromated arsenicals as the activr
ingredient, EFA case number 0647.
Due ehne Moode.
- neoeiMry. Howr»«r. my firm would Of tier to cnur
*re in tfM oott of dcvtloping. the following required
3. My firm KM 0fler»|
Mund by «n «rtftrj
to tfil following firJ
U.S. ENVIRONMENTAL PROTECTION AGENCY
Office of Pollution Prevention & Toxics (OPPT)
OPPT Library (7407)
401 M Street, SW
Washington, DC 20460
(202) 260-3944
ltd. TUt eff*> ««im«oe«bl« md indudttf *n o«tr w b«
•rmi could not 5* rwch«d otft«OM«. Th« offtf «MI m«d«
DATE
Howev«f. none of thow firm(i) tcc*pt*d my offer.
4. My firm rtqu«ti ttun EPA not tutp«nd tht r*giftr«tion(i) of my firm'* productd). if «ny of the firm* n*m«d in ptrioraph (3) •bovc
fwvt «ort«d to tubmit Cn« d*U lifted in p*-»gr«ph (2) •6o«« in «ooord«not with tnc Notioi. I wndtnund EPA will promptly inform
RM wfxtntr my firm must Mbmit d*t» to tvokf aiip«n«on of iti regmr«tion(t| under FlFRA Section 3(c)(2)(B). (Thit nnemem
do« not «pp(y to ipplictnu for new products.) I givt EPA pwmiuion to dudoM thii ttttement upon njqutn.
TTPCO NAME
DATE
71
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