GUIDANCE FOP THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
HELIOTHIS ZEA NPV
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
03 JUL 1234
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TEAM MEMBERS
TIMOTHY A. GARDNER RD
WILLIE NELSON RD
FRED BETZ SIS
JOHN JORDAN EAB
LIN VLIER EAB/BUD
BOB STORHERR RGB
GEORGE BEUSCH RGB .
JOHN CHEN TOX
LIZ ZUCKER EEB
DAVID BRASSARD SSB/BUD
MARK DOW ' SSB/BUD
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TABLE OF CONTENTS
PAGF
Introduction 1
I. Regulatory Position d
II. Requirement for Submission of Generic Data 17
III. Requirement for Submission of Product-Specific
Data 33
IV. Submission of Revised Labeling and Packaging
Information 34
A. Label Contents 34
1 . Product Name 34
2. Company Name and Address 34
3. Net Contents 34
4. Product Registration Number 35
5. Producing Establishment
Registration Number 35
6A Ingredient Statement 35
6B Pounds Per Gallon Statement 35
7. Front Panel Precautionary Statements 35
7A Child Hazard Warning Statements 36
7B Signal Word 36
7C Skull and Crossbones and Word Poison 36
7D Statement of Practical Treatment 36
7E Referral Statement 36
8. Side/Back Panel Precautionary Labeling 36
8A Hazard to Humans and Domestic Animals 37
8B Environmental Hazard 37
8C Physical or Chemical Hazard 37
9 Misuse Statement 38
10A Storage and Disposal Block 38
10B Directions for Use . ^ 38
B. Collateral Information 38
V. Instructions for Submission 39
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APPENDICES
I Bibliography
II FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8530-1
III Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6
IV Product Specific Data Report (End-Use Products)
EPA Form 8580-4
V-l 40. CFR §162.10 Labeling Requirements
V-2 Table of Labeling Requirements and Sample Labels
V-3 Physical/Chemical Hazards Labeling- Statement
V-4 Storage and Disposal Statements
11
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g)), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible. Each
registrant of a manufacturing-use product of the active
ingredient that wishes to continue to sell or distribute that
product must apply for reregistration.
To fulfill this Congressional mandate, we have established
the Registration Standards program which will review all
pesticide active ingredients first registered before January
1, 1977. These pesticides will be reviewed in use clusters
which are prioritized on the basis of a ranking scheme giving
preference to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product was
initially registered or studies that are now considered
insufficient. Our reassessment results in the development of
a regulatory position, contained in this document, on each
pesticide and its uses. The regulatory position may require
the registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limita-
tions, or other requirements designed to assure that proper
use of the pesticide poses no potential adverse effects to
human health or the environment.
The scientific review, which is not contained herein
but is available upon request, concentrates on the technical .
grade of the active ingredient and identifies missing generic
data. However, during the review of these data we are also
looking for potential hazards that may be associated with
the formulated (end-use) products that contain the active
ingredient. If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that certain registrants submit generic data that will answer
our questions regarding the hazard that may result from the
intended use of the pesticide under review. Further, §3(c)
(2)(B) provides that these data are to be submitted by those
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registrants who do not qualify for the forrnulator' s exemption
[FIFRA §3(c)(2)(D)]. Normally, this means that the registrants
who are responsible for filling the data gaps are the
manufacturing-use producers (basic suppliers of the active
ingredient). However, end-use producers will not qualify for
the formulator's exemption if the source of their active
ingredient: (1) is not registered with EPA, and/or (2) is
produced by the registrant's firm, or a firm which has
ownership in common with the registrant's firm. These end-
use producers can qualify for the formulator's exemption if
they change their source of supply to a registered source,
provided the source does not share ownership in common with
the registrant's firm. If the end-use product registrant
decides to switch sources, a new Confidential Statement of
Formula, EPA Form 8570-4, must be submitted to the appropriate
Product Manager within 90 days of receipt of this Guidance '
Document. The chart on the following page shows what is
generally required of those who do and do not qualify for the
formulator's exemption in the Registration Standards program.
If you decide to request to the Agency to discontinue the
registration of any of your products subject to the require-
ments of this document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt of
this document, that you wish to voluntarily cancel the registra-
tion^). If you decide to maintain your product registration(s)
you must provide the information described in the following
pages within the t'ime outlined. EPA will issue a notice of
intent to cancel or suspend the registration of any currently
registered product if you fail to comply with the requirements
set forth in this document.
Registrants are reminded that §6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible unreasonable adverse
effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S;
MAINTAIN
REQUIRED TO
REGISTRATION
Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active
Products*
Ingredient
To continue registration,
labeling, packaging and data
requirements must be satisfied
in accordance with this
document.
B. Multiple Active
Products
Ingredient
Generic data, as described in
this document will be required
to continue the registration
of the active ingredient under
review and some labeling pre-
cautions may also be required.
II. Products That Do Qualify For Only when additional restric-
The Formulator1s Exemption tions or labeling are needed to
protect man or the envrionment
will these products be subject
to the requirments of this
document. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label
Improvement Program and
special intent to cancel
notice.
* Registrants of End-use products that also produce a manufacturing-use
product'must fulfill the requirements specified in this document for
manufacturing-use product(s). Such end-use products will be subject to
the labeling changes required for products in "II" above.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
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I. REGULATORY POSITION
A. Introduction
This guidance document describes the Agency's current regula-
tory position regarding continued registration of manufacturing
use products (MPs) and end-use products (EPs) containing the
insecticide Heliothis zea NPV. The Agency's position is
based on an evaluation of all registered products with Nuclear
Polyhedrosis Virus of Heliothis zea as the sole active
ingredient. This document considers known microbial and
toxicological properties of this viral agent as well as
established exemptions from the requirements of tolerances on
all raw agricultural commodities, food and feed,and provisions
for quality control, including identification. From these
considerations the Agency sets forth the data and labeling
requirements that must be met by registrant and applicants
of Heliothis zea NPV products in order for the products to
be registered or reregistered under this document. To be
registrable under this document, MPs and EPs must list Nuclear
Polyhedrosis Virus of Heliothis Zea as the sole active
ingredient. The tables accompanying this document list the
data gaps which must be satisfied through submission of
additional information. Future MPs and EPs which differ
appreciably from those described in this document may require
that amendments be made to the document to reflect the
differences.
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B. Description of Chemical and Use Profile
Heliothis zea NPV is a double stranded polyhedral DNA virus
that is enclosed in a nucleocapsid in the polyhedrosis inclusion
body of Heliothis zea NPV. Its molecular weight is estimated
to be 30 x 106 to 90 x 106 daltons.
C.A.S. #2401-948-01 Shaughnessy #107301.
This viral agent is produced in the United States solely by
Sandoz, a subsidiary of Zoecon, Inc.
There are no federally registered MPs containing Heliothis
zea NPV. There is one federally registered EP which contains
Heliothis zea NPV as the sole active ingredient. It is
commercially formulated into a 0.4% wettable powder containing
a minimum of 4 billion polyhedral inclusion bodies per gram
of product.
Polyhedral Inclusion Bodies (PIB) of Heliothis Nuclear
Polyhedrosis Virus is also an accepted common name for Nuclear
Polyhedrosis Virus of Heliothis zea. The trade names and other
names include Biotrol VHZ, which was distributed by Nutrilite
Products, Inc. and Thompson-Hayward Chemical Company, and which
International Mineral and Chemical Corporation distributed
as Viron/H. International Mineral Company sold this product
to Sandoz, Inc. Nutrilite Products and Thompson-Hayward Chemical
Company no longer have registrations. Only Sandoz, Inc. with
its subsidiary Zoecon Corporation produce and distribute
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nuclear polyhedrosis virus of Heliothis zea, which they do
under the trade name of Elcar.
The inclusion bodies of Heliothis zea NPV are refractile,
crystal-like, and polyhedral shaped. Their average diameter is
about 0.86 microns; the diameter ranges in size from about 0.39
to 1.62 microns. The average dimensions of the virions after
release by alkaline extraction from inclusion bodies are 190 by
32 millimicrons. Occluded rods average about 320 by 90
millimicrons. Each inclusion body contains an average of 26
virions; the range is 17 to 54 virions.
The uses include all preharvest applications to raw agricul-
tural commodities at no preharvest interval through 0.001
pound per acre for foliar application. The specific crops
that the current registration lists are: beans, corn, cotton,
lettuce, peanuts, sorghum, soybeans, strawberry, tobacco and
tomato. There is only one regular registration and only one
24 (c) registration,both are by Sandoz Inc., a subsidiary of
Zoecon Industries.
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C. Regulatory Position
Based on a review and evaluation of all available data and
other relevant information on NPV of Heliothis zea, the
Agency has made the following determinations:
1. MPs and EPs containing Nuclear Polyhedrosis Virus of
Heliothis zea may be registered for sale, distribution
and use, subject to the terms and conditions specified
in this Standard.
2. Available data do not show that any of the risk criteria
listed in Section 162.11(a) of Title 40 of the U.S. Code of
Federal Regulations have been met or exceeded for the uses
of NPV of Heliothis zea specified in this Standard. How-
ever, gaps in the data base prevent the completion of the
Agency's risk assessment of this viral agent.
3. Because inclusion bodies of the virus are ubiquitous in
nature and are adsorbed on soil particles, very little
movement in soil is indicated, therefore groundwater is
not expected to be contaminated by infiltration of virus
particles through the soil profile.
4. There are no acceptable infectivity/pathogenicity data
available to assess the potential hazards to nontarget
terrestrial and aquatic wildlife from use of the Heliothis
NPV on crops. To address
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the hazards, the Agency requires results from six Tier
I non-target organism tests as noted in Table A.
5. Registrants must provide or agree to develop additional
data, as specified in the tables in this guidance document,
to maintain existing registrations or to obtain new regis-
trations of substantially similar products.
6. The quality control testing procedures as previously
stated must also be provided to maintain existing regis-
trations or new registrations, and exemptions from the
requirements ..of a tolerance.
D. Regulatory Rationale
The Agency has reviewed the available data concerning product
analysis, environmental, toxicology and ecological effects.
The Agency has determined that registration of nuclear polyhe-
drosis virus of Heliothis zea should continue.
An exemption for the requirement of a tolerance was granted
for residues in or on all raw agricultural commodities
including: corn, cottonseed, beens, lettuce, okra, peppers,
sorghum, soybeans, strawberries, tobacco and tomatoes.
Since the current micribial/biochemical guidelines were not
available at the time of the original registration,tests done
on NPV of Heliothis zea were similar to those conducted for.
conventional pesticides, and some were the same as those
\
currently required for viral pesticides.
These studies included:
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a. Intravenous, Intraperitoneal, Intracsrebral,
and Subcutaneous Injections
b. An In Vitro Tissue Culture Studies
c. A Chronic Feeding Study
d. A Teratogenicity Study
e. An Oncogenicity Study
f. A Rhesus Monkey Study
g. A Human Feeding Study -
There were no deleterious effects indicated by any of these
tests. The Human Feeding Study examination gave no suggestion
of viral inflammation,infection allergy or side effects to the
human volunteers.
Health Monitoring of Workers Associated with Heliothis NPV
Production
There were no observable deleterious effects indicated by any
of the many different Health Monitoring tests run on various
employees of several different companies at over a period of
as much as 4 1/2 years.
Serological studies were done for the detection of antibodies
specific to Heliothis zea of Nuclear Polyhedrosis Virus in
human serum by hemagglutination-inhibition neither clinical
symptomotogy,nor mmune response indicated subclinical infection
of Heliothis zea NPV appears to have had no observable adverse
effects on the general health of employees in handling the
viral product.
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In summary,/the Agency has concluded that it can continue the
registration'for this viral agent for the following reasons:
Adequate data are available to assess the acute oral,
inhalation and dermal toxicological and other biolog-
ical effects of this viral agent on humans.! £
2. The review and evaluation of the available data and
other information does not raise prudent concerns of
unreasonable adverse effects*jof Heliothis zea , as
registered. It has been concluded that this product
may be used, as presently registered and labeled ,and
that this product does not warrant additional regula-
tory action at this time.
3. Under FIFRA, the Agency cannot cancel or withhold
registration merely for the lack of certain data (See
sections 3(c)(2)(B) and 3(c)(7 ) of FIFRA). Rather,
issuance of this standard provides a mechanism for
identifying data needs. These data will be reviewed
and evaluated when they are received and the Agency
will determine at that time whether they will affect
the registration(s) of NPV of Heliothis zea.
E. Criteria for Registration Under This Standard
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This guidance document covers all manufacturing-use and end-use
products that contain Nuclear polyhedrosis virus of Heliothis ,'
zea as the sole active ingredient. Registrants and applicants
for registration of such products must comply with all terms
and conditions described herein. This includes making a commit-
ment to fill data gaps on a schedule specified by the Agency.
Also, registrants and applicants for registration must follow
the instructions contained in the document and complete and
i
submit the appropriate forms within the specified time frame. ',
F. Acceptable Ranges and Limits
1. Product Composition Standards
To be fully covered under this document, MPs and EPs
must contain Nuclear Polyhedrosis Virus of Heliothis
zea as the sole active ingredient. Each product- '
formulation proposed for registration must be fully
described as indicated in the data tables with the
appropriate certification of limits.
2. Acute Toxicity Limits
The Agency will consider for registration any MPs and
EPs provided the product is supported by toxicity, :
infectivity and pathogenicity data and the labeling
for the product bears appropriate precautionary state-
ments for microbial pesticides.
3. Use Patterns
To be registered under this document, end-use products
containing Nuclear polyhedrosis virus of Heliothis zea
must be labeled for use on all raw agricultural
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commodities as specified in 40 CFR §180.1027 and MPs
must be labeled to allow for formulation into SPs
which are intended for use on EPA accepted uses. The
attached index entry lists all registered uses, as well
as approved maximum application rates and frequencies.
Terrestrial Food/Feed Use
Beans, corn, cotton, lettuce, okra, peanuts, peppers,
sorghum, soybeans, strawberry, and tomatoes.
Terrestrial Non-Food
Tobacco
G. Required Labeling
All MPs and EPs containing Nuclear polyhedrosis virus of
Heliothis zea must bear appropriate labeling as specified in
40 CFR 162.10, in addition to the following specific labeling
requirements.
1. Labeling Requirements for Manufacturing-Use Products
a. Ingredient Statement
The ingredient statment for MPs must list the
active ingredient as:
Nuclear Polyhedrosis Virus of Heliothis zea xx%
and contains 4 billion PIB's/gram.
b. Use Pattern Statement
All MPs must state that they are intended only for
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c.
formulation into end-use products for any of the use
patterns listed below. A limiting factor will be the
data that support each use pattern. No use may be
included on the label where the registrant fails to
agree to comply with the data requirements in either
TABLE A or TABLE B for that use pattern.
iEnvironmental Hazard Statement
The statement, "Do not discharge effluent containing
this product directly into lakes,streams ponds,
estuaries, oceans or public waters unless this
product is specifically identified and addressed in
an NPDES permit. Do not discharge effluent containing
this product to sewer systems without previously
notifying the sewage treatment plant authority. For
guidance, contact your State Water Board or Regional
Office of the Environment Protection Agency."
2. Labeling Requirements for End-Use Products
a• Ingredient Statement
The ingredient statement for EPs must list the
active ingredient as: Nuclear Polyhedrosis Virus
of Heliothis zea xx%. Contain 4 billion
PIB1s/gram.
b. Environmental Hazard Statement
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Do not apply directly to water or wetlands. Do not
contaminate water by cleaning of equipment or dis-
posal of waste.
•
H. Tolerance Reassessment
An exemption from the requirement of a tolerance has been
established for Nuclear polyhedrosis virus of Heliothis zea
on all raw agricultural commodities under 40 CFR §180.1027.
(a) For the purposes of this section the viral
insecticide must be produced with an unaltered and
unadulterated linoculum of Heliothis zea nuclear
polyhedrosis virus. The integrity of the seed
virus must be assured by periodic checks, with
the latest methods as .indicated by this Standard.
(b) Each lot of active ingredient of the viral
insecticide shall have the following specifications:
(1) The level of extraneous bacterial
contamination of the final unformulated viral
insecticide will not exceed 10^ colonies per
gram as determined by an aerobic plate count
on trypticase soy agar.
(2) Pathogens, e.g., Salmonella, Shigella, or
Vibrio must be absent.
(3) Safety to mice as determined by standardized
intraperitoneal injections and and a standardized
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21-day feeding study must be demonstrated.
(4) Integrity of the viral product as determined
by the most sensitive and standardized serological
test must be demonstrated.
(c) Exemptions from the requirement of a tolerance
are established for the residues of the microbial
insecticide nuclear polyhedrosis virus of Heliothis
zea, as specified in paragraphs (a) and (b) of this
section, in or on all raw agricultural commodities
including: corn, cottonseed, beans, lettuce, okra,
peppers, sorghum, soybeans, tobacco, and tomatoes.
A wide variety of toxicity studies have been used in support
of this exemption from .the requirement of a tolerance. These
data included:
a. A chronic feeding study:
No toxicological effects were associated with ingestion
of the Nuclear Polyhedrosis Virus of Heliothis zea from
the test animals.
b. A teratology study:
There were no significant differences in the maternal
body weight gain, and the mean fetal weight found
between the treated and control groups.
c. An oncogenicity study:
Negative oncogenic effects were observed at the level
tested.
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d. Rhesus monkey study:
No viral infectivity of H_. zea NPV was found in
the lymph node tissues and blood samples of the
treated monkeys. In addition, body temperature
and blood chemistry values from the treated monkeys
were normal.
e. Human feeding study:
This examination gave no suggestion of viral
inflammation, allergy or side effects to the
human volunteers .
f. Health Monitoring of Workers Associated with Heli-
othis NPV Production:
Heliothis zea NPV appeared to be without observable
effect to the general health of employees in hand-
ling the viral product.
Conclusion: Judging from the data reviewed to date there
appears to be few adverse effects to man or the environ-
ment resulting from use of this viral pesticide, NPV of
Heliothis zea.
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II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the document is 'a Notice issued under
the authority of FIFRA Section 3(c)(2)(B) and describes,
in table format, the data required for maintaining the
registrability of each product. Additionally, a
bibliography (Appendix II-1) is included that identifies
these data considered as part of the data base supporting
this standard. EPA has determined that additional
generic, data described in this Notice must be submitted
to EPA for evaluation in order to maintain in effect
the registration(s) of your product(s) identified in an
attachment to the cover letter accompanying this'
document. As required by FIFRA Section 3(c)(2)(B),
you are required to take appropriate steps to comply
with this Notice.
EPA may suspend the registration of each of those
products unless, within the specified time, you have
informed EPA how you will satisfy the requirements of
this Notice. Any such suspension will remain in effect
until you have complied with the terms of this Notice.
B. What Generic Data I/ Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must
be submitted. The required data must be submitted and
any necessary studies must be conducted in accordance
with EPA-approved protocols, the Pesticide Registration
Guidelines £/, or data collected under the approved
protocols of the Organization for Economic Cooperation
and Development (OECD). If you wish not to develop
data which are necessary to support the registration or
reregistration of certain uses appearing in your
labeling, you may delete those uses at the time you
submit your revised labeling.
!_/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation
of the risks of all products containing that ingredient (or all
such products having a certain use pattern), regardless of any
such product's unique composition or use. Product-specific
data relate only to the properties or effects of a product with
a particular composition (or a group of products with closely
similar composition).
2_/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982, in 47 Federal Register 53192.
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All Tier I ecological effects data must be done on the
technical grade material unless there is an acceptable
rationale as to why it should not be done.
Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that
type for each major formulation category (e.g.,
emulsifiable concentrates, wettable powders, granulars,
etc.). These are classified as generic data and when
needed are specified in Table A. EPA may possess data
on certain "typical formulations" but not others.
Note; The "typical formulation" data should not be
confused with product-specific data (Table P) which are
required on each formulation. Product-specific data
are further explained in Chapter IV of this document.
C. Options Available for Complying With Requirements to
Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-2] for each of your products. On that form you must
state which of the following methods you will use to comply
with the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly develop
(or share in the cost of developing) the data. If
you elect this option, you must notify EPA which
registrant(s) are parties to the agreement.
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3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix II-3).V
4. Request that EPA amend your registration by deleting :i
the uses for which the data are needed. (This option
is not available to applicants for new products.)
5. Request voluntary cancellation of the registration(s) of
your products for which the data are needed. (This
option is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology;
and Extensions of Time i
i
EPA recognizes that you may disagree with its conclusions
regarding the appropriate ways to develop the required
data or how quickly the data must be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
V FIFRA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mech'anism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop jointly.
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing
could increase costs, tie up testing facilities, and subject an
unnecessarily large number of animals to testing.
As noted earlier, EPA has discretion not suspend the
registration of a product when a registrant fails to submit
data required under FIFRA Section 3(c)(2)(B). EPA has concluded
that it is appropriate to exercise its discretion not to suspend
in ways which will discourage duplicative testing. Accordingly,
if (1) a registrant has informed EPA of the intent to develop
and submit data required by this Notice; and (2) a second reg-
istrant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under
FIFRA Section 3(c)(2)(B)(iii)]; and (3) the first registrant
has declined to agree to enter into a cost-sharing agreement,
EPA will not suspend the second firm's registration. While the
first firm is not required to agree to jointly develop data,
EPA is not required to force the second firm to engage in
economically inefficient duplicative testing in order to
maintain its registration.
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contained in the reports of the Expert Groups to the Chem-
ical Groups, Organization for Economic Cooperation and
Development (OECD) Chemicals Testing Programme, you must
submit the protocol for Agency review prior to the initia-
tion of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product Manager.
The extension request should state the reasons why you con-
clude that an extension is appropriate. While EPA considers
considers your request, you must strive to meet the dead-
line for submitting the required data.
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TABLE A
GENERIC DATA REQUIREMENTS FDR NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS ZEA
S158.16!
151-10,
151-11,
151-12,
151-13,
151-15,
151-16
151-17,
S158.165 MICROBIAL PESTICIDE DATA REQUIREMENTS
Guideline Citation and
Name of Test
5 Product Analysis for
Microbial Agents
20 Product identity
21 Manufacturing process
22 Discussion of formation of
unintentional ingredients
23 Analysis of samples
25 Certification of inerts
Analytical methods
26 Physical and chemical properties:
Color
Odor
Density or
Test!/
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Guidelines Are Data Footnote
Status Required? 2/3/ Number
Yes No
R [X~] [ 1
R [X~] f~l
R [jTi r~i
tX~] f~l
[xj O
R fX~] [ 1
R [XJ [~1
R fX~l [ 1
R rx i r i
R [X ] f 1
Specific
Gravity
Corrosion
Characteristics
TGAI
fX 1
Key: R = Required data; CR = Conditionally required data; TGAI = Technical grade of the active ingredient.
MP=Manufacturing use product; EP= End-use product, ( TGAI=MP==EP )
I/ All data must be submitted on all of the above required tests no later than August 1986 .
2/ Data maybe referenced or cited, if previously submitted.
3/ Updated product analysis (identification) are required for this Standard to maintain the tolerance
exemption and for the registration or reregistration of the product.
-------
-22-
TABLE A
GENERIC DATA REQUIREMENTS FDR NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS 7,EA
§158.165 MICROBIAL PESTICIDE DATA REQUIREMENTS
Guideline Citation and
Name of Test
Test1/
Substance
Guidelines
Status
Are Data
Required?
Yes No
S158.165 Product Analysis for
Microbial Agents
(continued)
151-18, 27 Submittal of samples
TGAI/EP
[Rl
[X ] [ "]
Footnote
Number
I/ There are no currently establish TGAI,MP or EP each equals each other (TGAI = MP= EP ),
hence the purist grade of the product is what normally would be considered technical and tests should
technical and tests should be performed on it.
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-23-
TABLE A
GENERIC DATA REQUIREMENTS FDR NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS ZEA
Must Additional
Microbial Pesticides-Residue Does EPA Have Data Data Re Submitter!
Data Requirement For To Satisfy This Bibliographic Under FIFPA Section Footnote
Microbial Agents Composition Requirement? Citation 3(c) (2) (B)? !!ilui1[l!?er__.
§158.165 Microbial Agents Residue Chemistry N/A N/A N/A _ _ 1
_!/ Residue data requirements shall apply to microbial pest products when Tier II or Tier III toxicology are required as
specified in Toxicology table A for microbial agents. Reference C Table - Sections 158.50 and 15R.100, Federal
Register Vol. 47, No. 227, Wednesday, November 24, 1982, Proposed Rules, which indicates which test would trigger
residue data requirments.
-------
-24-
TABLE A
GENERIC DATA REQUIREMENTS TOR NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS ZEA
Microbial Pesticide Does EPA Have Data
Toxicology Data To Satisfy This
Requirements And The Use Requirement? (Yes,
Substances To Be Tested Composition Pattern No or Partially)
5158.165 Toxicology:
Microbial agents
Acute oral
Tier 1 :
152-30 Acute oral EP/MP/TGAI A,B Yes*
152-31 Acute dermal EP/MP/TGAI A,B Yes *
152-32 Acute inhalation EP/MP/TGAI A,B Yes *
152-33 I.V., I.V., I.P
injection . TGAI/EP A,B Yes *
152-34 Primary dermal MP/EP A,B Yes *
152-35 Primary eye MP/EP A,B No
152-36 Hypersensitivity study MP/EP A,B Yes *
Must Additions
Data Be Subnr
Bibliographic Under FIFRA
Citation 3(c)(2)(B)?
00067550 No
00091306
0008222.1 No
00081441
00081440 No1/
00075283
00089268
00065851
00081436 No2/
00081439
00082220
00062591
00089268
00065851
00075283 No
Yes
00081450 No3/
00082223
00062582
-------
GENERIC DATA REQUIREMENTS
-25-
TARLE A
FOR NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS ZEA
Microbial Pesticide Does FPA Have Data Must Additional
Toxicology Data To Satisfy This Data Re Submitted
Requirements And The Use Requirement? (Yes, Bibliographic Under FIFRA Section
Substances To Re Tested Composition Pattern No or Partially) Citation 3(c)(2)(B)?
$158.165 Toxicology:
Microbial agents
(continued)
152-37 Hypersensitivity-
Human MP/EP A,B Yes
152-38 Cellular immune
response TGAI/EP A,B No
152-39 Tissue Culture TGAI/EP A,B Partially
Tier II:
Acute oral MP A,B No
Acute inhalation MP A,B No
Subchronic oral TGAI A,B No
Acute I. P., I.C TGAI A,B No
Primary dermal TGAI A,B No
Primary eye TGAI A,B No
Cellular irmiune response TGAI A,B No
Teratogenicity TGAI A,B Yes
00065898*
00070481*
00081449*
00082091*
00101026*
00081442*
00067552*
00101020*
00101041*
00101040*
00101029*
00062583*
00065851*
No3/
No3/
No4/
N/A5/
N/A6/
N/A7/
N/AR/
N/A^/
N/AW
N/AlV .
NOW
-------
-26-
TABLE A
GENERIC DATA REQUIREMENTS FOR NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS ZEA
Microbial Pesticide
Toxicology Data
Requirement And The
Substances To Be Tested Composition
§158.165 Toxicology:
Microbial agents
(continued)
Virulence enhancement TGAI
mammalian mutagenicity TGAI
Tier III:
Chronic feeding TGAI
Oncogenicity TGAI
Does EPA Have Data Must Additional
To Satisfy This Data Re Suhn.it. te
Use Requirement? (Yes, Bibliographic Under FIFRA Sect
Pattern No or Partially) Citation 3(c)(2)(B)?
A,B No N/A13/
A,B No N/A-1-4/
A,B Yes 00081436* No15/
00089268*
' 00081438*
00075280*
00081437*
00089265*
00101003*
00101036*
00070480*
00082090*
A,B Yes 00065851* Nol6/
00062581*
00065900*
00101018*
00062580*
00062579*
00047589*
00101028*
Mutagenicity
Teratogenicity
TGAI
THAI
APB
A,B
No
N/A
N/A
-------
-27-
TABLE A
GENERIC DATA REQUIREMENTS FDR NUCLEAR POLYHEDROSIS VIRUS OF HELICTHIS ZEft
Microbial Pesticide
Toxicology Data
Requirement And The
Substances To Be Tested
Composition
Does EPA Have Data
) To Satisfy This
Use Requirement? (Yes, Bibliographic
Pattern No or Partially) Citation
Must Additional
Data Re Submitted
Under FIFRA Section
3(c)(2)(R)?
Footnotes
Number
Si58.165 Toxicology:
Microbial agents
(continued)
ADDITIONAL TOXICOLOGY STUDIES:
(Data Not Required)
Human Feeding Study
TGAI
A,B
Yes
00062588*
00044040*
00075281*
00081461*
00070487*
No
Rhesus Monkey Study
TGAI
A,B
Yes
00090423*
No
(Footnotes)
(1) Required if 20 percent or more of the aerodynamic equivalent of the product (as registered or under conditions of
use) is composed of particulates under 10 microns in diameter.
(2) Data required for products as follows: (i) intravenous ("IV") infectivity study for viral agents; (ii) intra-
cerebral ("1C") infectivity study for viral agents.
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-28-
TARLE A
GENERIC DATA REpUIREMEMTS FDR NUCLEAR POLYHEDROSI5 VIRUS OF HELIOTHIS ZEA
Microbial Pesticide Does EPA Have Data Must Additional
Toxicology Data To Satisfy This Data Re Submitter!
Requirement And The Use Requirement? (Yes, Bibliographic Under FIFRA Section
Substances To Be Tested Composition Pattern No or Partially) Citation 3(c)(2)(R)?
(Footnotes continued)
(3) Required if commonly recognized use practices will result in repeated human contact by inhalation or dermal routes.
(4) Data required for products whose active ingredient is a virus.
(5) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus) is observed
in the test animals treated in the Tier 1 acute oral infectivity tests.
(6) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus) is observed
in the test animals treated in the comparable Tier I acute inhalation tests.
(7) Required if marked edema or broad erythema was observed in the Tier I dermal irritation study.
(8) Required if severe ocular lesions are observed in the Tier I primary eye irritation study.
(9) Required if results of the Tier I cellular immune response test indicate abnormalities.
(10) Required when Tier I test on viral agents shows replication of the virus in mammalian hosts and significant damage
to mammalian cells.
(11) Required if any of the following criteria are met: (i) Acute infectivity tests are positive in Tier I studies:
(ii) Adverse cellular effects are observed in cellular immune response studies; or (iii) Positive results are
obtained in tissue culture tests with viral agents.
(12) Required when the potential for chronic adverse effects (e.g., replication or persistence of viral or subviral
constituents) are demonstrated by any of the Tier II tests (except primary dermal, primary ocular, and mammalian
mutagencity tests).
(13) Required when the potential for oncogenic effects is indicated (e.g., adverse cellular effects due to presence,
replication, or persistence of viral or subviral constituents, or mutagenic effects) by any of the Tier II tests
except the primary dermal and primary ocular studies.
*A11 data was submitted by or purchased by SANDOZ, INC. whose subsidiary ZOECON, INDUSTRIES now controls
the only registered product containing this active ingredient.
-------
-29-
TAPLR A
GENERIC DATA REQUIREMENTS FDR NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS ZEA
Microbial Pesticide
Toxicology Data
Requirement And The
Substances To Be Tested
Composition
Use
Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Re Submitted
Under FIFRA Section
3(c)(2)(B)?
(Footnotes continued)
(14) Required when the potential for mutagenic effects is indicated (e.g., adverse cellular effects due to presence,
replication, or persistence of viral or subviral constituents) by any of the Tier II tests except primary dermal
or primary ocular studies.
(15) Required when the potential for teratogenic effects is expected based on the presence or persistence of fungi,
viruses in mammalian species as a result of testing performed in Tier II, except primary dermal and primary ocular
studies.
(16) Data submitted in support of registering NPV of Heliothis zea was by conventional data requirements for registration
as the "biorational guidelines" had not been promulgated (1975). Now these data are not needed.
(17) Required when the potential for mutagenic effects is indicated (e.g., adverse cellular effects due to presence,
replication, or persistence of viral or subviral constituents) by any of the Tier II, except primary dermal or
primary ocular studies.
(18) Required when the potential for teratogenic effects is expected based on the presence or persistence of viruses
in mammalian species as a result of testing performed in Tier II, except primary
dermal and primary ocular studies.
(19) These data are not required for this active ingredient (NPV of Heliothis zea).
-------
-30-
TABLE A
GENERIC DATA REQUIREMENTS FDR NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS ZEA
Does EPA Have Data Must Additional
To Satisfy This Data Re Submitted
Microbial Pesticide Use Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirements CompositionV Pattern^/ No or Partially) Citation 3(c)(2)(B)
§158.165 Nontarget organisms
and environmental
expression: Microbial agents
Tier I:
154-16
154-17
154-18
154-19
.1.54-20
154-2.1
154-22
154-23
154-24
Avian oral
Avian injection test
Wild mammal testing
Freshwater fish
testing
Freshwater aquatic
invertebrate testing
Estuarine and marine
animal testing
Plant studies
Nontarget insect
testing
Honey bee testing
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
No
No
No
No
No
No3/
No
No
No
Yes
Yes
No
00082222* Yes
Yes
00082222* No
No
Yes
Yes
Key: _!/ TGAI = Technical grade of the active ingredient; EP = End-use product.
V The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food.
3/ Not required by current use pattern.
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-31-
TARLE B
GENERIC DATA REQUIREMENTS FDR NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS ZEA
§158.165 MICROBIAL PESTICIDE DATA REQUIREMENTS
Guideline Citation and
Name of Test
Test Guidelines
Substance^/ Status
$158.165 Product Analysis for
Microbial Agents
151-10, 20 Product identity
151-11, 21 Manufacturing process
151-12, 22 Discussion of formation of
unintentional ingredients
151-13, 23 Analysis of samples
151-15, 25 Certification of inerts
151-16 Analytical methods
151-17, 26 Physical and chemical properties:
Color
Odor
Density or
Specific
Gravity
Corrosion
Characteristics
TGAI
TGAI
TGAI
R
R
R
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
R
R
R
R
R
R
Are Data
Required?£/V
Yes No
[X ] [ ]
[XJ
[XJ
[X~]
[_1
O
n
[X ] [ 1
tx j
(XJ
[X 1
t_i
[ i
IX ] [ ]
Footnote
Number
Key: R = Required data; CR = Conditionally required data; TGAI = Technical grade of the active ingredient.
_!/ All data must be submitted on all of the above required tests no later than August 1986
2/ Data may be referenced or cited, if previously submitted.
3/ Updated product analysis (identification) are required for this Standard to maintain the tolerance
~~ exemption and for the registration or reregistration of the product.
-------
-32-
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING NUCLEAR POLYHEDROSIS VIRUS OF HELIOTHIS _ZFA
§158.165 MICROBIAL PESTICIDE DATA REQUIREMENTS
Guideline Citation and Test Guidelines Are Data Footnote j
Name of Test • Substance^/ Status Required?2/V Number j
Yes No ~ ; [
§158.165 Product Analysis for • [
Microbial Agents j
(continued)'
151-18, 27 Submittal of samples TGAI [R] [X~] f ] j
I/ R = Required data; CR = Conditionally required data; TGAI = Technical grade of the active ingredient;
MP = Manufacturing use product; EP = end-use product. (There are no currently established TGAI or MP
each equals each other (TGAI = MP = EP); hence, the purest grade of the product is what is normally
considered technical material and tests should be performed with it.)
2/ All data must be submitted on all of the above required tests no later than August 1986 Data
may be referenced or cited, if previously submitted.
3/ Updated product analysis (identification) are required for this Standard to maintain tolerance
exemption an for the registration or reregistration of the product.
-------
Ill. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This chapter applies only to.manufacturing-use
products, not end-use products.
A necessary first step in determining which statements
must appear on your product's label is the completion and
submission to EPA of product-specific data* listed on the
form entitled "Product Specific Data Report" (EPA Form 8580-4,
Appendix III-l) to fill "gaps" identified by EPA concerning
your product. Under the authority of FIFRA Section 3(c)(2)(B),
EPA has determined that you must submit these data to EPA in
order to register or reregister your product(s). All o'f these
data must be submitted not later than six months after you
receive this guidance document.
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table B permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
_V Product specific data pertains to data that support
the formulation which is marketed; it usually includes product
chemistry data and acute toxicology data.
-33-
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IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This section applies only to manufacturing-use products,
not end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are
sufficiently standardized to avoid user confusion.
As pajrt of your application, you will be required to submit
draft labeling consistent with: applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR 5162.11(c))],
packaging [40 CFR §162.16], and labeling [40 CFR 162.10, Appendix
V-2 and IV-2], as indicated by the following paragraphs of this
chapter of the guidance document.
You must submit the revised labeling set forth in this
guidance package within 90 days of receipt of this guidance package
A. Label Contents
40 CFR $162.10 (Appendix V-2) requires that certain
specific labeling statements must appear at certain locations
on the label. This is referred to as format labeling.
Specific label items listed below are keyed to Tables D, E,
and F (Appendix IV-2).
Item 1. 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.
See Appendix V-2. [40 CFR §162.10(b)]
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.
See Appendix V-2. [40 CFR S162.10(c)]
Item 3. NET CONTENTS - A net content statement is required
on all labels. The preferred location is the bottom of the
front panel immediately above the company name and address,
or at the end of the label text. The net contents must be
stated in terms of weight, expressed as avoirdupois pounds
-34-
-------
and ounces, and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces" rather than "26 ounces." In
addition to the required units specified, net contents may
be expressed in metric units. See Appendix V-2. [40 CFR
§162.10(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.
See Appendix V-2. [40 CFR Sl62.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est.," is the final estab-
lishment 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 registratio'n number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix V-2. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and 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 ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in-the
body of other text. See Appendix V-2. [40 CFR §162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
-35-
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Size of Label Signal Word as Re- "Keep Out of Reach
on Front Panel quired Minimum Type of Children"
in Square Inches Size All Capitals as Required
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 - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix V-2. [40 CFR §162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix V-2.
[40 CFR §162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On
products assigned a toxicity Category I on the basis of oral,
inhalation, or dermal 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. See Appendix V-2. [40 CFR
S162.10(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. See Appendix V-2. [40 CFR $162.10(h)(1)(iii ) ]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See appendix V-2. [40 CFR §162.10(h)(1)(iii)J
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The pre-
cautionary statements as 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 pre-
ceding 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. See Appendix V-2. [40 CFR §162.10 (h)(2)]
-36-
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Item 3A. 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 taken to avoid'
accident, injury or damage. See Appendix V-2. [40 CFR
§162.10(h) (2) ( i")
Item 33. - 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. See Appendix V-2. [40 CFR
Item 3C. PHYSICAL OR CHEMICAL HAZARD
1. Flammabil i ty statement. Precautionary statements
relating to f lammabi 1 i ty of a product are required to
appear on the label if it meets the criteria in
Appendix IV- 3 . 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 f larnmabil i ty statements.
2. Criteria for declaration of non-f lammability . The
following criteria will be used to determine if a
product is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°F (177°C) as determined by
the method specified in 40 CFR § 163 . 61-8 ( c ) ( 13 ) (, i i )
of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following critera:
i. The flame extension is zero inches, using the
method specified in 40 CFR $1 63 . 61-8 ( c ) ( 13 ) { i i ) ;
ii. There is no flashback; and'
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C), as
determined bv the method soecified in 40 CFR
§163.61-8(c)(13)(i).
-37-
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3. Declaration of non-flammability. Products which meet
the criteria for non-flammability specified above may
bear the notation "non-flammable" or "nonflammable
(gas, liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall not
be highlighted or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFR'
§163.61-10(c) demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or
reducing capability, or mixing with other substances
to produce toxic fumes.
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
See Appendix V-2. [40 CFR S162 .10(1)(2)(ii)]
Item 10. 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. Make certain that the statement you use
pertains specifically to your product. 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 V-4 for the latest specific
storage and disposal product label statements.
Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix V-2. [40 CFR §162.10]
B. Collateral Information
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and other graphic printed matter which all referred to
on the label or which are 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
-38-
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made part of the response to this notice and submitted for
review.
V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Product Manager -17 (Timothy A. Gardner)
Phone No. (703) 557-2690
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, DC 20460
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA
Form 8580-1 and revised labeling. Refer to Appendix II
with appropriate attachments.
2. Within 6 months from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4 (Appendix
III) .
c. Two copies of any required product-specific data.
3. Within the time set forth in Table A, all generic data
must be submitted by the affected registrant(s) .
Note; If for any reason any required test is delayed or aborted
so that meeting the agreed submission time will be delayed,
notify the Product Manager listed above.
You will be informed at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 8570-1).
-39-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Heliothis Standard
00044040 Heimpei, A.M.; Buchanan, L.K. (1965) Human Feeding Tests using the
Nuclear polyhedral Virus of Heliothis zea. (U.S. Agricultural
Research Service, Insect Pathology Laboratory, unpublished
study including letter dated Sep 7, 1966 from R.S. Roe to M.W.
Parker; CDL.-104333-A)
00047582 Wbodard, G. (1969) Proposed Protocol: NPV-Virus-Technical: Poly-
hedrosis Virus Safety Evaluation by a Single and Repeated Subcu-
taneous injection, by a Single and Repeated Oral Administration
and by Single and Repeated Inhalation Exposure in Rhesus Mon-
Keys. (Unpublished study including letter dated Jul 1, 1970
from G. Wcodard to Michael F. Markel, received on unknown date
under 8G0722; prepared by Wocdard Research Corp., submitted by
Nutrilite Product, Inc., Euena Park, Calif.; CDL:093032-A)
00047589 Totman, L.; Bleiberg, ^[.J.- Cronin, M.T.I. (1968) Polyhedral Virus:
Evaluation of the Carcinogenic Potential in Mice: Addendum to
the Final Report. (Unpublished study received on unknown date
under 8G0722; prepared by Wccdard Research Corp., submitted by
Nutrilite Product, Inc., Buena Park, Calif.; CDL:093032-I)
00056871 Ignoffo, C.M. (1973) Effects of entcmopathcgens on vertebrates.
Pages 141-164, In Annals of the New York Academy of Sciences:
Tfolume 217. By ? N.P. (Also in unpublished submission re-
ceived Feb 7, 1977 under 275-18; submitted by Abbott Laborato-
ries, North Chicago, 111.; CDL:231523-E)
00062579 Cronin, M.T.I. (1966) Polyhedral Virus: Summary of Kistopathologi-
cal Observations in Dogs. (Unpublished study received Get 2,
1968 under 8G0697; prepared by Wbcdard Research Corp., submitted
by International Minerals & Chemical Corp., Libertyville, 111.;
CDL: 091209-8)
00062580 Wbodard Research Corporation (19??) Polyhedral Virus: A Summary
Evaluation of Observations on 20 Day Old Rat Fetuses. (Unpub-
lished study received Get 2, 1968 under 8G0697; submitted by
International Minerals & Chemical Corp., Libertyville, 111.;
CDL:091209-C)
00062581 Durlco, R.S.; Bleiberg, M.J. (1967) Polyhedral virus Evaluation of
the Carcinogenic Potential in Mice. 57 to 78 week interim rept.
(Unpublished study received Cct 2, 1968 under 8G0697; prepared
by Wcodard Research Corp., submitted by International Minerals s
Chemical Corp., Libertyville, 111.; CDL:091209-D)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLICC-RAPHY
Citations Considered to be part of the Data Base Supporting
Registrations Under the Reliothis Standard
00062582 . Rostenberg, A., Jr. (1967) Report on the Investigation to Determine
the Skin Irritancy and Potential Sensitizing Ability of the
Heliothis Nuclear Polyhedrosis virus on Humans. (Unpublished
study received Get 2, 1968 under 8G0697; prepared by Univ. of
Illinois, Dept. of Dermatology, submitted by International Min-
erals & Chemical Corp.., Libertyville, 111.; CDL:091209-E)
00062583 Rafajko, R.R. (1967) Final Report: In vitro Tissue Culture Studies
with Nuclear Polyhedrosis Virus of Heliothis. (Unpublished
study received Get 2, 1968 under 8G0697; prepared by Medical Re-
search Consultants, Inc., submitted by International Minerals &
Chemical Corp., Libertyville, 111.; CDL.-091209-F)
00062584 International Minerals & Chemical Corporation (1967) Published and
Unpublished Studies Demonstrating Specificity of Heliothis Virus
to Other Insects, Invertebrates and Vertebrates Including Hu-
mans. (Unpublished study received Get 2, 1968 under 8G0697;
CDL: 091209^-G)
00062588 He impel, A.M.; Buchanan, L.K. (1967) Human feeding tests using a
nuclear-polyhedrosis virus of Heliothis zea. Journal of In-
vertebrate Pathology 9(l):55-57. (Also in unpublished submis-
sion received Get 2, 1968 under 8G0697; submitted by Interna-
tional Minerals & Chemical Corp., Libertyville, 111.; CDL:
091209-L)
00062591 Ignoffo, C.M.; He impel, A.M. (1965) The nuclear-polyhedrosis virus
of Heliothis zea (Eoddie) and Heliothis virescens (Fabricius):
V. Toxicity-pathogenicity of virus to white mice and guinea
pigs. Journal of Invertebrate Pathology 7(3):329-340. (Also
in unpublished submission received Get 2, 1963 under 8G0697;
submitted by International Minerals & Chemical Corp., Liberty-
ville, 111.; CDL:091209-O)
00065851 Bellies, R.P.; Benson, B.W.; Scott, W.J., Jr.; et al. (1967) Poly-
hedral Virus for Insect Control. (Unpublished study received
Get 5, 1968 under 8F0697; prepared by Wscdard Research Corp.,
submitted by International Minerals & Chemical Corp., Liberty-
ville, 111.; CDL:091215-A)
00065898 Jeffords, F.W. (1971) Health Monitoring of Personnel Associated
with H. Zea Virus Production. (Unpublished study received on
unknown date under 8G0697; submitted by International Minerals
& Chemical Corp., Libertyville, 111.; CDL:091212-B)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Fart of the Data Ease Supporting
Registrations Under the Heliothis Standard
00065900 Curlco, R.S.; Totman, L.; Bleiberg, M.J.; et al. (1968) Polyhedral
Virus: Evaluation of the Carcinogenic potential in Mice. Final
rapt. (Unpublished study received on unknown date under 8G0697;
prepared by "vfccdard Research Corp., submitted by International
Minerals & Chemical Corp., Libertyville, 111.; CDL:091212-D)
00066815 International Minerals & Chemical Corporation (1973) Quality
Control Data on Viron/H Shipped during 1972. (Compila-
tion; unpublished study received Jun 15, 1973 under 3F1304;
CDL:092206-D)
00067550 Ignoffo, C.M.; Batzer, O.F.; Barker, W.M.; et al. (1970) Fate
of Heliothis nucleopolyhedrosis virus following oral admin-
istration to rats. Pages 357-362, In Proceedings, IV Inter-
national Colloquiun on Insect Pathology; Aug 25-28, 1970, Col-
lege Park, Maryland. N.P. (Also in unpublished submission
received Jun 15, 1973 under 3F1304; submitted by International
Minerals & Chemical Corp., Libertyville, 111.; CDL:092206-A)
00067551 Shapiro, M.; Ignoffo, C.M. (1970') Serolcgical characterization
of the Heliothis nucleopolyhedrosis virus. Pages 147-151, In
Proceedings, IV International Colloquiun on Insect Pathology;
Aug 25-28, 1970, College Park, Maryland. N.P. (Also in un-
published submission received Jun 15, 1973 under 3F1304; sub-
mitted by International Minerals & Chemical Corp., Liberty-
ville, 111.; CDL.-092206-C)
00067552 Batzer, O.F.; Huang, H.T. (1973) Attempted Detection of Antibodies
Specific to Heliothis zea Nucleopolyhedrosis Virus in Human
Serun by Hemagglutination-inhibition. (Unpublished study re-
ceived Jun 15, 1973 under 3F1304; submitted by International
Minerals S. Chemical Corp., Libertyville, 111.; CDL:092206-E)
00070480 Nutrilite Products, Incorporated (1965) Introduction: Biotrol
VHZ. (Unpublished study received Mar 13, 1981 under 6296-EX-2;
CDL:127376-A)
00070481 Halverson, G.R.; Dulmage, H.T. (1965) Human Testing Program. (Un-
published study received Mar 13, 1981 under 6296-EX-2; submitted
by Nutrilite Products, Inc., Buena Park, Calif.; CDL:127376-B)
00070482 Nutrilite Products, Incorporated (19??) Planned Carcincgenicity
Tests. (Unpublished study received Mar 13, 1981 under 6296-EX-
2; CDL:127376-C)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Heliothis Standard
00070487 He impel, A.M.; Buchanan, L.K. (1965) Human Feeding Tests Using the
Nuclear Polyhedral Virus of Heliothis zea. (U.S. .Agricultural
Research Service, Entomology'Research Div., Insect Pathology
Laboratory and Office of Personnel, Employee Health Div.; unpub-
lished study; CDL.-127379-C)
00072677 Sandoz, Incorporated—Crcp Protection (1978?) Micrcbial Examina-
tion of Production Batch- preparation of Elcar. (Compilation;
unpublished study, including published data, received Mar 6,
1981 under 11273-EX-23; CDL:099944-F)
00075280 Barnes, R.W.; Meinecke, C.F.; McLane, W.C.; et al. (1970) Long-term
feeding 'and other toxicity-pathogenicity studies on rats using a
commercial preparation of the nuclear-polyhedrosis virus of
Heliothis zea. Journal of Invertebrate Pathology 16(1):112-
115. (Also in unpublished submission received Feb 28, 1971 un-
der 6296-EX-2; submitted by Nutrilite Products, Inc., Buena
Park, Calif.; CDL:127382-A)
00075281 Chauthani, A.R.; Murphy,.D.; Claussen, D.; et al. (1968) The effect
of human gastric juice on the pathcgenicity of Heliothis zea
nuclear-polyhedrosis virus. Journal of Invertebrate Pathology
12(2):145-147. (Also in unpublished submission received Feb 28,
1971 under 6296-EX-2; submitted by Nutrilite Products, Inc.,
Buena Park, Calif.; CDL:127382-3)
00075283 Meinecke, C.F.; McLane, W.C.; Rehnborg, C.S. (1970) Inhalation and
dermal allergenicity studies of a nuclear-polyhedrosis virus of
Heliothis zea in guinea pigs. Journal of Invertebrate Pathol-
ogy 15(2):207-210. (Also in unpublished submission received Feb
28, 1971 under 6296-EX-2; submitted by Nutrilite Products, Inc.,
Buena Park, Calif.; CDL:127382-D)
00081436 Nutrilite Products, Incorporated (1968) Acute Toxicity Studies in
Small Rodents. (Unpublished study received on unknown date un-
der 8G0722; CDL:091244-A)
00081437 Nutrilite Products, Incorporated (1965) Ninety-day Feeding Study
Using Sprague-Dawley Rats. (Unpublished study received Mar 3,
1968 under 8G0722; CDL:091244-B*)
00081438 Nutrilite Products, Incorporated (1967) Two-year Feeding Study
Using Sprague-Dawley Pats to Assess Carcincgencity Potential
of Biotrol VHZ—a Continuation of 90-day Study. (Unpublished
study received Mar 3, 1968 under 8G0722; CDL:091244-C)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Keliothis Standard
00081439 Nutrilite Products, Incorporated (1967) Eighteen (18) Month Mouse
Test To Assess Carcinogenicity Potential of Biotrol VHZ by Re-
peated Subcutaneous Injections. (Unpublished study received
Mar 3, 1968 under 8G0722; CDL:091244-D)
00081440 Nutrilite Products, Incorporated (1967) Inhalation Studies Using
Guinea pigs To Test for Possible Allergenicity of Biotrol VHZ.
(Unpublished study received Mar 3, 1968 under 8G0722? CDL:
091244-E)
00081441 Nutrilite Products, Incorporated (1967) Dermal Exposure Studies on
Guinea Pigs To Test for possible Allergenicity of Biotrol VHZ,
(Unpublished'Study received Mar 3, 1968 under 8G0722; CDL:
091244-F)
00081442 Nutrilite Products, Incorporated (1966?) Completed and Planned
Antibody Tests. (Unpublished study received Mar 3, 1968 under
8G0722; CDL: 091244^")
00081449 Dulmage, H.T.; Halverson, G.R. (1968?) Report of Clinical and
Physical Examinations of Laboratory Personnel Heavily Exposed
to the Nuclear Polyhedrosis Virus of Heliothis zea. (unpub-
lished study received Mar 3, 1968 under 8G0722; submitted by
Nutrilite Products, Inc., Buena Park, Calif.; CDL:091244-O)
00081450 Pehnborg, C.S.; Westall, E.B.; Halverson, G.R. (2967) Report of
Clinical and physical Examinations of Laboratory personnel
Heavily Exposed to the Nuclear Polyhedrosis Virus of Heliosis
zea since December, 1965. (Unpublised study received Mar 3,
1968 under 8G0722; submitted by Nutrilite Products, Inc., Buena
Park, Calif.; CDL:091244-P)
00081453 He impel, A.M. (1964?) Preliminary Discussions on a Protocol of
lexicological and Pathcgenicity Tests using Insect Viruses.
(Unpublished study received Mar 3, 1968 under 8G0722; submitted
by Nutrilite Products, Inc., Buena Park, Calif.; CDL:091244-S)
00081461 Chauthani, A.R.; Murphy, D.; Claussen, D.; et al. (1968) The Effect
of Human Gastric Juice on the Pathcgenicity of Heliothis zea .
(Boddie) Nuclear Polyhedrosis Virus. (Unpublished study re-
ceived Mar 3, 1968 under 8G0722; prepared in cooperation with
Univ. of California—Riverside, Dept. of Biological Control,
submitted by Nitrilite Products, Inc., Euena Park, Calif.; CDL:
091244-AC)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATICN STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Heliothis Standard
00082090 Nutrilite Products, Incorporated (1965) Toxicity and Pathogenicity
Studies Completed. (Unpublished study received jul 5, 1966 un-
der 6G0481;*CDL:090539-C)
00082091 Dulmage, H.T.; Halverson, G.R. (1965) Report on Clinical and
Physical Examinations of Laboratory personnel Heavily Exposed
to the Nuclear Polyhedrosis virus of Heliothis zea. (unpub-
lished study received Jul 5, 1966 under 6G0481; submitted by
Nutrilite Products, Inc., Buena Park, Calif.; CDL:090539-D)
00082220 Nutrilite Products, Incorporated (1967) Toxicity Study of Biotrol
VHZ on Rats and Mice. (Compilation; unpublished study received
May 6,-1968 under 6G0481; CDL:090540-E)
00082221 Nutrilite Products, Incorporated (1967) Dermal Exposure Studies on
Guinea Pigs To Test for Possible Allergenicity of Biotrol VHZ.
(Unpublished study received May 6, 1968 under 6G0481; CDL:
090540^3)
00082222 Nutrilite Products, Incorporated (1967) Toxicology—Related to '.
Safety of Animals (U.S.D.A. Requirements). (Compilation; unpub-
lished study received' May 6, 1968 under 6G0481; CDL:090540-H)
00082223 Nutrilite Products, Incorporated (1968) Toxicology—Human Testing.
(Compilation; unpublished study received.May 6, 1968 under
6G0481; CDL:090540-I)
00089265 Dulmage, H.T.; He impel, A.; Ignoffo, C.M. (1959?) Present and
Planned Animal Tests: Safety Testing Procedures: Standardization
Procedures for Biotrol VHZ: Nutrilite Products' Preparation of
the Folyhedrosis Virus of Heliothis zea. (Protocol; unpublished
study received Aug 6, 1965 under PP0418; prepared in cooperation
with Nutrilite Products, Inc., submitted by U.S. Dept. of
Agriculture, Agricultural Research Service, unknown location;
CDL:090452-A)
00089266 He impel, A.M. (1965?) Toxicity-pathogenicity Tests of Vfoite Mice
and Guinea Pigs Using the Nuclear Folyhedrosis Virus from
Trichoplusia ni(Hubner) . (U.S. Agricultural Research serv-
ice, Entomology Research Div.; unpublished study; CDL:090452-C)
00089268 He impel, A.M.; Ignoffo, C.M. (1964) Report of Toxicology Tests
with Heliothis zea (Bcddie) To Appraise the Effect of This
Insect Virus on Laboratory Animals. (U.S. Agricultural Research
Service, Entomology Research Div.; unpublished study; CDL:
090452-F)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Heliothis Standard
00089274 Aizawa, K. (1954) Neutralization of silkworm jaundice virus by
human serun. Nature 174:(Cct)748-749. (Also in unpublished
submission received Aug 6, 1965 under PP0418; submitted by U.S.
Dept. of Agriculture, Agricultural Research Service, unknown
location; CDL:090452-M)
00089275 Aizawa, K. (1954) Immunolcgical Studies of the Silk-worm Jaundice
Virus: 1.- Neutralization and Absorption Test of the Silkworm
Jaundice Virus: 2. Agglutination Reaction of the Polyhedral
Bodies: 3. Experiments on the Defense of Infection in the Silk-
worm Jaundice. (Unpublished study received Aug 6, 1965 under
PP0418; submitted by U.S. Dept. of Agriculture, Agricultural
Research Service, unknown location; unpublished study;. CDL:
090452-N)
00089276 U.S. Agricultural Research Service (1961?) Data Showing Response
of Various Vertebrate Animals to Exposure by Insect Viruses.
(Unpublished study; CDL:090452-0)
00090423 Wcodard, M.W.; Banerjee, B.N.; Wbcdard, G. (1971) Heliothis NPV VR-
7083: Safety Evaluation in Rhesus Monkeys by Single and Repeated
Subcutaneous Injection; Single and Repeated Inhalation Exposure;
Single and Repeated Oral Administration. (Unpublished study,
including letter dated Mar 11, 1971 frcm C.M. Ignoffo to S. Ban-
erjee, received Jun 4, 1971 under 8G0697; prepared by Wbcdard
Research Corp., submitted by International Minerals & Chemical
Corp., Libertyville, 111.; CDL:091213-A)
00091306 Ignoffo, C.M.; Batzer, O.F.; Barker, W.M.; et al. (1970) Fate of
Heliothis Nuclecpolyhedrosis virus following Oral Administra-
tion to Rats. (Unpublished study received Mar 23, 1971 under
4456-EX-ll; submitted by International Minerals & Chemical
Corp., Libertyville, 111.; CDL:127260-A)
00101003 Nutrilite Products, Inc. (1959?) Present and Planned Animal Tests:
Safety Testing Procedures, Standardization Procedures for
Biotrol VHZ: Nutrilite Products' Preparation of the Polyhedrosis
Virus of Heliothis Zea. (Protocol; unpublished study received
Jun 1, 1965 under 6G0481; CDL:092770-C)
00101005 U.S. Agricultural Research Service (19??) Testing for Safety of
Bacterial and Viral Pesticides. (Unpublished study; CDL:
092705-A)
00101017 International Minerals & Cnenicai Corp. (1969) Ohsnistry of Heli-
othis Virus as an Insecticide. (Compilation; unpublished
study received Jun 4, 1971 under 8F0697; CDL:093002-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be part of the Data Base Supporting
Registrations Under the Eeliothis Standard
00101018 Totman, L.; Bleiberg, M. (1968) Polyhedral Virus: Evaluation of
the Carcinogenic Potential in Mice: addend un to the Final Re- ''
port. (Unpublished study received Jun 4, 1971 under 8F0697;
prepared by Wccdard Research Corp., submitted by International
Minerals & Chemical Corp., Libertyville, IL; CDL:093002-3)
'00101020 Shapiro, M. (1971) Serological Studies on Heliothis Nucleopoly-
hedrois Virus. (Unpublished study received on unknown date
under 8G0697; submitted by International Minerals & Chemical
Corp., Libertyville, IL; CDL:093003-B)
00101021 Vfcodard Research Corp. (1969) Proposed Protocol: NPV-virus-tech-
nical :- Polyhedrosis Virus: Safety Evaluation by a Single and *
Repeated Subcutaneous Injection, by a Single and Repeated Oral
Administration and by Single and Repeated Inhalation Exposure
in Rhesus -Monkeys. (Unpublished study received on unknown
date under 8G0697; submitted by International Minerals & Chem-
ical Corp., Libertyville, IL; CDL:093003-D)
00101026 International Minerals & Chemical Corp. (1973) Serological Tests
on Employees Involved in Viron/H production in.1972. (Unpub-
lished study received on unknown date under 3F1304; CDL:
094118-C)
00101028 Vocdard, G. (1967) Safety Evaluation Tests with the Nuclear Poly-
hedrosis Virus of Keliothis. (unpublished study received
Cct 2, 1968 under 8F0697; prepared by Woodard Research Corp.,
submitted by International Minerals & Chemical Corp., Liberty-
ville, IL; CDL:096410-A)
00101029 Rafajko, R. (1967) In Vitro Tissue Culture Studies with Nuclear
Polyhedrosis virus of Heliothis. Final rept. (Unpublished
study received Cct 2, 1968 under 8F0697; prepared by Medical
Research Consultants, Inc., submitted by International Minerals
& Chemical Corp., Libertyville, IL; CDL:096410-D)
00101032 He impel, A. (1967?) Progress in Developing Insect Viruses as
Microbial Control Agents. (U.S. Agricultural Research Service,
Entomology Research Div.; unpublished study; CDL:096410-J)
00101034 Surmers, M. (1978?) Development and Standardization of Identifi-
cation and Monitoring Techniques for Baculovirus Pesticides:
EPA Grant 805232. (Texas A & M Univ. for U.S. Environmental
Protection Agency, Health Effects Research Laboratory; unpub-
lished study; CDL:099124-B)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be part of the Data Base Supporting
Registrations Under the Heliothis Standard
00101036 Meinecke, C.; MeLane, W.; Rehnborg, C. (1970) Toxicity-cathcgen-
icity studies of a nuclear-polyhedrosis virus of Heliothis zea
in white mice. Journal of Invertebrate Pathology 15(1):10-14.
(Also In unpublished submission received Feb 28, 1971 under
6296-EX-2; submitted by Nutrilite Products, Inc., Buena Park,
CA; CDL:127372-A)
00101040 Nutrilite products, lac. (1971) Safety Evaluation: Biotrol VHZ.
(Conoilaticn; unpolished study received Seo 16, 1971 under
6296-EX-2; CDL:127383-B)
00101041 Nutrilite. Products, Inc. (1972) Safety Evaluation: Biotrol VHZ. -
(Compilation; unpublished study received on unknown date under
6296-EX-2; CDL:127384-3)
00101044 Sandoz, Inc. (1974) Elcar Insecticide: Chemical Study. (Com- .
pilation; unpublished study received Jun 6, 1975. under 11273-
17; CDL:220964-A)
00101045 Shieh, T. (1975) Studies on Stability, Persistence and Field
Efficacy of Elcar (SAN 240 WP). (Unpublished study received
Jun 6, 1975 under 11273-17; submitted by Sandoz, Inc., Crop
Protection, San Diego, CA; CDL:220964-B)
-------
f* i y «s 4 — — . / i / ^
.'No.
PfiOCL'CT ,SA,M =
APPLICANTS NAMc
DATE GUIDANCE DOCUMENT ISSUED
Wrrh rtssiCT « the rrquiramsfit ta ^bmr: ";-;n3ric" dra impcad by tri^ ?!FHA sctisn 3(C)(2](B) natics ccnai.isd In the rafsfsn
Guidancs Occomsnt, I 3.71 rsponding in ths fciiowing msnnar:
! 1, I wiil submit data in a tirnsly manner a stsfy the fallowing rsquirsmjfiti If the tsst prscsdura I-will usa davistB frnm (or sn not
necrfiao in) the fl^strjtion Geidsiinss or the Protocoli carrainsd in tin Hspora of Expert Groups to the Chamical: Group, OECD
r*,.— .-..if jtj-jng Projfamma, I endosa tin pn:tocalj that I wiil OH:
C 2. I havs emarsd into an a^retmem with era or mcra ath*r r^ijtra.Ta under FiFHA acdon 3(C)(Z)!3)(il) to srjrry til a foilcwing dab
requirement! Tha aaa, and my requind prataeaij, wil bfl ajbrnrrad ta =?A by:
NAME OF OTriEH HEGI5THANT '. ~ ~
Q 3. I Kidca a camplmd "Cartrficstian of A tamp t to Snnr lira tn Agnamsnt with Qthsr B»gt«nrru for D jvslopmant of Daa" wrth
mptct to tii< following data nquinmantc
LJ 4. I rrquert thai you amend my rajatirtlon by dairring tiie followng usi (thb option a not available to sjpliurrtJ for new pradura}:
D S. I request voluntary tsncillr.ion of the registration cf thij produci [Tnii option is not available a app.licantj for rww produra.)
'S AUT'riGaiZEO EE.'fiSSE.NTATi'Vs
DATS-
EPA PCKTO a£3O-1 (10-32)
-------
Appendix 11-3
QMS Acorova! Ne. 2COO-C-**3 fs.rsires: 12-31-53!
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, cert if-/ ALL four Items) FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(S) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT OAT =
ACTIVE INGREDIENT
EPA COMPANY NUM3EH \
\
i
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notics, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offerad in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
Bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer wss made
to the following firrn(s) on the following date(s):
NAME OF FIRM
it
DATE OF OFFER
However, none of those firm(s) accsotsd my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notica. I understand EPA will promptly inform
me-whether my firm must submit data to avoid suspension of its registration (s) under FIFRA Section 3(c)(2)(B). (This statsmefit
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8530-6 (10-82)
104
-------
Appendix IV
EPA Registration Mo.
PRODUCT SPECIFIC DATA REPORT
Guidance Document for_
Date
Registration
Guideline No.
§158.20
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
63-8
63-9
63-10
Name of Test
Identity of
ingredients
Statement of^
coroosition
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 -
Vacor pressure
Dissociation
constant
Test. not
required
for my
product
listed
above
(check
below)
I am complying with
data reouirements bv
Citing MRID3
Submit-
ting
Data
(At-
Ltacned )
(For EPA Use Only)
Accession Numbers
Assigned
105
-------
Appendix IV
(continued)
EPA Reaistraticn No.
PPDCUCT SPECIFIC DATA REPORT
Guidance Document for
Date
Registration
Guideline No.
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
pH
Stability
Oxidizing/reducing
reaction
Flammability
Explod ability
Storage stability •
Viscosity
Miscibility
Corrosion
cnaracteristics
Dielectric break-
down-voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute innalation,
LC-50 rat
Prinary eye
irritation, rabbit
Primary dermal
irritation ,L
Dermal- sens itiza-
tion
Test not
required
for my
product
listed
above
(cneck
below)
I am oorplying witn
data requirements 'bv
Citing MPJD4
Sudmit-
ting
Data
(At-
tacned)
(For EPA Use Only)
Accession Numbers
Assigned
106
-------
§ 162.10
(2) An offer to pay tie person com-
pensation. with regard to tr-e approval
of the application, to the eswnt re-
quired by r'Lr-KA sections 3UX1XD)
and 3)ifn% othar th*»i
these that are preaaat solely because
of the incorporation into the product,
dunes formulation, of oae or more
other registered pesticide products
purchased from another producer,
then the applicant sir^u also comply
with 5 1813-5 as Co such active ingredi-
ent, and the application shall contain
an actaowledsmsnt that lor purposes
of PIPHA section 3
t+t PB 278S3, H.17 U. 1ST93
(a) General—<1) Contents of Vie
label £very pesticide products nr,aH
bear a label containing the informa-
tion specified by the Act and the regu-
lations In this Part. The contents of a
label must show dearly and promi-
nently the f ollowtns:
(1) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(11) The "«*"* and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section:
(ill) The net contents as prescribed
Sn paragraph
-------
§ 162.10
erf
(4) ^lacam*7U q/ L,«» dls-
charsB osncrol yaive.
(3) /oiw or misleading statement*.
Pursuant to section :v»Hng 7hlch con-
(11) A false or niisleading staiamsnt
cancsmlng tha eiffictrresaa of ths
prcduct as a peart rida or
(Ill) A f*'-1** or ml^teading
about the value of tha product for
purpcaej other f-^i*^ as a pesticida or
(iv) A false or aislesdlng comparison
•rtth other pesticides or deTices:
(7) Any statement directly or Indi-
rectly implying that tha pesticide or
devlca Is recommended or endorsed by
any agency of tha Federal Govern-
2JSSC
(71) The nasaa of a pesticide which
cnnr-alm rso or more principal active
ingredients if th? name suggests one
or more but not all such principal
active ingredients even though the
aam»>!i of the other Ingredients are
statad elsewhere in the labeling;
(711) A true statement used in such a
way as to give a fai«« or m<.>•!_•»,
Such reproductions must be of micro-
film reproduction o^ality.
323
-------
§ 162.10
(b) Hasnt, brand, or trademarie. U)
The name, brand, or tradaruwit under
which tie pegtleicla product la said
*>i*4i appear on the iront pansl of the
label.
(2) No najTHt, brand, or trademark
may appear on the label wnich:
(1) 13 ^1** Or TnialottfUng g?
-------
§ 162.10
oi
the label II there la an outzida con-
tainer or wrapper through which :hs
ingredient statement cannot ba clsariy
read, the ingredient statement muss
also appear on such outside cnm.-airnTr
or wrapper. II the lisa or form of the
pacSase p*1111"** It impracticable to
place the Ingredient statement on the
front panel of the label, permission
may be granted Tor the ingredient
statement to appear elsewhere,
(11) The text of toe tnaredlgnt state-
mfmt must run parallel with other
text on the panel on which it
and mUSt DO Cl23Tiy
from "vl must act be placed in &3
body of other tssc.
(3) Homes to d* toed in inyredimt
statement. The nauTifl used 'or each in-
grediene <^ai1 be ths
CODZBOn narpo, Ji th8T8 li
lowed by tha <*>»<«T^ir^i nasa. TIio
conmos nanie may b* uz*d aigng only
if St la Tell toown. If no common ruunn
has been established, the chemical
nairy» aj/^rni of tooicoiogical
hazard Includtus hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups;
thcsa required on the front p*"";.^ of
the labeling and those which Tq*y
appear elsewhere. Sped fie require-
ments concsmina content, placement.
type stsa, and promin^nca are given
below.
(3) Acsyfscy o/ stated ys.11i my
UD o «u nataa>9 299
"V**
330
-------
162.JO
^3 rttBKfl a 77
nan.
ii» cr zi^rs MSJJ^JI a
TZfx
(1) .efomcn hazsfA, F.grjzl ifcrd — (A)
roriciiy Ciir?cry /. AU p-esticide prod-
ucts meeting the criteria of Toziciry
Category I ^«-H bear on the front
panel the rigsfl.! word "I^anger." In ad-
dition If the product was assigned to
Tosicity Categiory I on ilia tsais of 1U
oral. iTigai^.n'"* or csrtail tcxicitj (a-s
distinct ironi stnn ajicl eye local af-
iiia gord ""Poison"
in rsd on i bacisround of
conrrasdns color and cie afcill and
crcssbones shall is^ear Sn inzmsdiow
pm-riTnity io tiie "srord "poison."
(3) TbriJiiv CiiJ7t?T7 IL AU pesti-
cide pnxlucta aeatlr.g tiie criwrla of
Tozcitr Category n ^H.^n tear on tiis
front panel tie sixnal vord "77am-
tns."
(C) Torsciiy Czteyory III. AU pesti-
cide products nseetlng the criteria of
Toxldty Category IH .^hall bear on
the front panel the signal — ord "Cau-
tion.'*
CD) Tcriciiv Cateyory IV. An pesti-
cide prcxiuca 3:eetin? the critsr-a of
TorLcity Category IV shall bear on the
front panel the signal -sord "CsAitlon."
<2) I/AS o/ «c7iiii toonii Use of any
yigT-ai word(3) associsied with a hisher
Tosicity Category la not permitted
ezcept when the Agency determines
fhtLt such labeiins Is neetssary to pre-
vent unrsisonatile advsrse eifecu on
or the envLronnient. In no cose
more than one human hscard
ord appear on the front panel
of a label.
(11) GVi&J hcs&rd •xaminy. rrery pes-
ticide pnxiuct label shall bear on the
front panel the statement "keep cut of
reach of children." Only In cases
where the liteiihood of contact with
children during distribution. rcartLec-
Ing. storage or use Is demonstrated by
the applicant to be errrenaeiy remote,
or if the nature of the pesticide Is such
that it is approved for use on infants
or gman children, may the
tor waive this requirement.
nt«vi—
-------
§ 142.10
TIHs 4i.
of S.ivirsnraarf
and precautionary statements is rs- catins :he partirui
quired below shall acpsir tasstha? on routes; of e.-ipcsure and the pr^cau-
the lac-ai under the isnsrai heading ticrui 10 b-a •--••="•; to avoid accident,
uri/io" appropriate 3uiheadlns3 of P*
.<-cr--.,»_( ., zr,T~n>i-i<» ,-ri n fir-***'<- ini. csdfid by the appropriate hazard.
^^.C^^^fr^^^^ .^.J ^^ uL^*i^i»^3 Z^^i. t^ '_ J Q L^ ^ -^ _2 't tt ^* - ^ '_[ * * '^
ma^s," "Snvironznentai Hazard" and ^^ rono^s ^Je depi^ ;-;.
"Physical or Chemical ^azard. C3l prsC3Utionar7 statemaats. Ti-ese
(i) Hazard do r.ymarij cr,d domestic stateinenis must" be modified or es-
(A) Where a hazard esists to panned to rsilect sp-edilc hazards.
i fWsson, or uaJi.^A fi i b> ^f
) 4 savxxrea '.'rfatea or aasoroaa tnraugn
201 L Go ret ^»dv* tagcf Cc!^=t cz* scrry
on
Ifrort BCTOI i^twrju'g
>v» trn sun csna?» Co- aon rrv
. Cc -*ct ^t ft «yos» sn usn. sr 3n C£firv
rromyi TM A«od cvcac ~ai asn. fra or LXJU*^. Vt caia cr
(11) Sn-ffiromrifnial hazards. Where a
hazard exists co son target
excluding hums
iriftU, precautionary sta
quired stating the narore of the
hazard and the appropriate precau-
tions to avoid potential accident,
injury or damans. Szamples of the
hazard statements and -the circ-.i:
stances under which they
follow:
CA.) If a p-esticide intended for out-
door use contains an active Lzigridieni
•sith a m^mrra!ia.n acute oral LD« of
100 or '.ess, the statement "This Psati-
cde Is Toxic co Wildlife" is required,
(3) If a pesticide intended for out-
door use contains an active ingredient
with a Vjh acute LCX. of 1 ppm or less,
the statement "This Pesticide is Toss
to Pish" Ls required.
(.Cl If a pesticide intended for out-
door use contains an active Lnsrsdient
with an avian acute oral LZU of 100
nag/'ij or less, or a suhacute dietary
LC.. of 500 pptn or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or -la-rrmai*. the statement
"This pesticide is extremely toxic to
wildlife
-------
Oicp'tar !—cnviranman-t-s! ?rc!->r»icn Agsr.cy
162.10
(Hi) Phyriczi or zfisrr.iszi /icscrdi ity or explosive ciLaract5:--s::e3 of the
"arr.i^-g 3ta.;amen:3 on the •"•» . — .-i.ov!. p^jticice are required as 'cilcws
Aixw SO" ? «na not o«r 1W F
nav i^oex cr ecan tena.
(1) IHrwiioru for Use— <1) C-snersi
ity of dirsciicris. EiT2Ct:oE3 ior usa
must be stated La tarns — hich can be
read and understcxjd by the
person 11^ sly to use or to su-
pervise the use at the pesticide. 'vThen
followed, directions nurc be adequate
to protect the public from fraud and
from personal Injury and to prsvest
unreasonable adverse eifecta on the
environment.
!ii» adverse ef-
fects on TTiar! or the environment; anri
(J) The product Is °-l^o a drug and
regulated under the provisions of the
Federal Tcod, Drug and Ccsmetic Act.
333
-------
<3 lid 10
(O Detailed directions 'or use may
be omitted ircm the iaislir^ of pesti-
cide products which are intended .'or
use only by .'emulators Ln pr-panns
pesticides for sale- to :he public, pro-
Tided that;
(I) Tier? Ls information readily
available to tie farmuiators an the
ccmpcsition, toxicity, methc
-------
APPENDIX V-2
LABELING.REQUIREMENTS OF. THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
713
LABEL ELEMENT
Product naine
Company name
and address
Net contents
EPA Est. No.
EPA Reg. No.
Ingredients
statement
Pounds/ga 1 Ion
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
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel ,
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed ^y. . .," 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.
1
107
-------
APPENDIX V-2 (continued)
ITEM
7C
7D
7E
8
HA
(3D
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
c
Referral
statement
Side/back panel
precau t iona ry
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPHCAB.ILI1Y
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
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
j.
j
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
108
-------
APPENDIX V-2 (continued)
ITEM
OC
9A
9C
10A
IOC
1UD
U.S.
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
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
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
109
-------
STATEMENTS
IIA/AIIIJS IO HUMANS
III DOMESTIC ANIMALS!
' CAIM IOM
viHONMENi AL
IIA?AMI>S
PHYSICAL Oil ClltMICAL
MARAUDS
DIRECTIONS FOR USE
GENEHAL CLASSIFICATION
II .. • v.olJIlim I.I f .,!.,.I l,w 10 ..I.
Kill product In » tn»nn*r iii£Hiullt«nl
wiltt ill UtiHiMp.
ME-ENinV STATEMENT
OEANO
DISPOSAL
SIOHAGG =:
OlSI'OSALr
PRODUCT
NAME
I
• ':'
i
l'
!'!
I
ACTIVE INGHEDIENT:.
INEHT INGIiEOIENTS:.
X
V.
TOTAL: 100.00X
THIS PRODUCT CONTAINS LOS OF PER GALLON
KEEP OUT OF nEACII OF CHILDREN
CAUTION
STATEMENT OF PRACTICAL TREATMENT
IF SWALLOWED :
IF INIIALEO=
IF ON SKIN =
IN IN EYES =
SEE SIDE PANEL FOR ADDITIONAL PRECAUTIONARY
STATEMENTS
MFC UY
TOWN. STATE:=
El'A ESTAULISHMENT NO.:
EPA REGISTHATION NO. =
NET CONTENTS.
CROP::
CROP::
CROP::
CROP::
CROP:
CROP:
CROP
CROP:
CROP:
WARRANTY STATEMENT
-------
Aocendix V-3
?HYSICAL-CHEMIC AL HAZARDS
Criteria
I. Pressurized Containers
A. Flasnpoint at or below
20°F; or if tnere is a
flasnback at any valve
opening.
B.' Flasnpoint above 20°F
and not over 80°F; or
if tne flame extension
is more tnan 13 incnes
long at a distance of
6 incnes from tne
valve.opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flasnpoint at or below
20°F.
B. Flasnpoint above 20°F
and over 80°F.
C. Flasnpoint over 80°F
and not over 150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and neated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
neat, 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
neat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
neated surfaces.
Flammable." Keep away from
neat and open flame.
Do not use or store near
neat and open flame.
D. Flashpoint above
150°F.
None required.
-------
Appendix V-4
'STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to Dear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in trie directions for use portion of
tne label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include tne Heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
Required type size
for the heading
STORAGE AND DISPOSAL
square inches | (all capitals
10 and under 6 point"
Above 10 to 15 8 point
Above, 15 to 30 10 point
Over 30 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. 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 tne 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.
-------
Appendix V-4
(continued)
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.
B. 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 tne exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain tne 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
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal 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 St-ate Pesticide or Environmental Control
Agency, or tne Hazardous Waste representative at tne
nearest EPA Regional Office for guidance."
Tne labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
-------
3.
Appendix V-4
(continued)
"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 tne Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all otner products, except those intended for
domestic use, must bear tne following pesticide disposal
statement:
"Wastes resulting from tne use of this product may be
disposed of on site or at an approved waste disposal
facility."
Products intended for domestic use only must bear tne
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1.' All products intended for domestic use must bear one
of the following container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol, products
(bags )
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly^ before discarding^ in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trasn. Do not incinerate or puncture.
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse(or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then orfer
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,
stav out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by otner
aporoved state and local procedures.
-------
Appendix V-4
(continued)
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
*
Compressed gas
cylinders
Completely empty liner by snaking 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 author-ities .
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 wording).
^Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, .listed
on the first page of this Appendix.
-------
Appendix V-4
(continued)
Pesticides tnat are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts):
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide •
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclonexyl-4/6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimetnyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb .
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, scnradan)
Parathion
-------
Appendix V-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List
Active Ingredients continued:
Pnenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alconol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strycnnine and salts
0,0,0,0-Tetraetnyl ditniopyropnospnate (suifctepp)
Tetraetnyl pyrophospnate
Tnallium sulfate
Thiofanox
Toxapnene
Warfarin
Zinc pnospnide
There are currently no inert ingredients for commercial pesticides
on tne "Acutely Hazardous" List (RCRA "E" List).
-------
Appendix V-
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (nydrate)
Chlordane (tecnnical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chloropnenol
4-Chloro-o-tolu idine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phtnalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluororaethane (Freon 12®)
3,5-Dichloro-N-(1,1-dimethy1-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Etnylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
-------
Appendix V-Jp
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F° List)
Active Ingredients:
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Metnyl cnloride
2,2'-Metnylenebis (3,4,6-tricnlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentacloropnenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroetnane
Tetracnloroethylene
2,3,4,6-Tetracnlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11®)
2,4,5-Trichloropnenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
-------
Appendix V-
(continued)
"Toxic" Commercial Pesticide Products
(RCRA "Fn
List)
Inert Ingredients:
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dicnlorodifluorometnane (Freon 12*)
Diethyl pnthalate
Dimetnylamine
Dimethyl phthalate
1,4-Dioxane
Etnylene oxide
Formaldenyde
Formic acid
Isobutyl alconol
Meleic annydride
Metnyl alconol (metnanol)
Metftyl ethyl Icetone
Methyl metnacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroetnane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon
Vinyl chloride
Xylene
-------
Index of Currently Acceptable Uses
EPA Index to Pesticide Chemicals
:107301 POLYHEDRAL INCLUSION BODIES OF HELIOTHIS NUCLEAR POLYHEDROSIS VIRUS*
TYPE PESTICIDE; Biological Control Agent
FORMULATIONS; WP (0.4%) (contains a minimum of'4 billion polyhedral
inclusion bodies per gram of product)
GENERAL WARNINGS AND LIMITATIONS; Maintain a pH of approximately 6 to 9
.of the spray tank mixture. Do not allow the spray mixture to stand in the
tank for more than 12 hourg. Activity of the virus may be impaired by
storage at temperatures above 80 F (26.7 C). If held beyond the current
growing season, refrigerate or freeze until the following growing season.
Agricultural Crop Tolerances (other than those listed in the text);
All raw agricultural commodities (including okra and peppers) - exempt
Definitions of Terms;
Claims for pest control limited to suppression of populations are indicat-
ed by parenthesized pest name.
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
AGRICULTURAL CROPS
'28001AA
'28005AA
'28007AA
'13020AA
/28015AA
'28019AA
'28023AA
'01016AA
'26003AA
'11005AA
CTBCBOC
1TBCBNC
General Warnings and Limitations; May be applied by aircraft or ground
equipment in 3 to 20 gallons of water per acre. Stickers may be added if
heavy dew or rain is expected. Apply lower rates for suppression of light
infestations and higher rates for suppression of moderate infestations.
Beans
Lettuce
Peanuts
Sorghum
Soybeans
Strawberry
Tobacco
Tomato
(Corn earworm/
Tomato fruitworm/
Bollworm
v (larvae)):
(Tobacco budworm
(larvae))
Exempt
No preharvest interval through
0.001 pound per acre for foliar
application.
0.125-0.25 Ib Foliar application. Apply at first
0.4% WP/A sign of newly hatched larvae and re-
(0.4% WP) peat at 3 to 7 day intervals as long
as egg deposition continues. Thor-
ough coverage is essential for con-
trol.
*Elcar
Heliothis nuclear polyhedrosis virus
Issued: 8-19-82.
Provisional Update: 6-13-84
III-107301-1
-------
EPA Index to Pesticide Chemicals •
POLYHEDRAL INCLUSION BODIES OF HELIOTHIS NUCLEAR POLYHEDROSIS VIRUS
Site and Pest
ITBCBOC
ITBCBNC
Dosages and Tolerance, Use, Limitations
Fornmlation(s)
Beans cluster (continued)
(Cotton)
(Corn earworm/
Tomato fruitwonn/
Bollworm
(larvae))
(Tobacco budworm
(larvae))
0.0625-0.125 Foliar application. Apply at first
Ib 0.4% WP/A sign of newly hatched larvae and re-
(0.4% WP) peat at 3 to 7 day intervals as long
as egg deposition continues. Tank
mix with•Bacillus thuringiensis.
0.0625-0.125
Ib 0.4% WP/
3-5 gal/A
(0.4% WP)
Foliar application. Apply by air-
craft. Apply at first sign of egg
deposition or newly hatched larvae.
Repeat at 3 to 5 day intervals to
sustain suppression or until ade-
quate larval reduction is achieved.
Tank mix with chlordimeform.
9001500
AAAAAAA
AERIAL, MOTHPROOFING AND TANK iMIX APPLICATIONS
Aerial Application
Refer to
AGRICULTURAL CROPS
All sites
9900300
AAAAAAA
Tank Mix
Refer to
AGRICULTURAL CROPS
All sites
Issued: 8-19-82
III-107301-2
-------
EPA Index to Pesticide Chemicals
POLYHEDRAL INCLUSION BODIES OF HELIOTHIS NUCLEAR POLYHEDROSIS VIRUS
Listing of Registered Pesticide Products by Formulation
0.4% vettable powder
polyhedral inclusion bodies of heliothis nuclear polyhedrosis virus
(107301)
011273-00017
Issued: 8-19-82 III-107301-3
-------
EPA Index to Pesticide Chemicals
POLYHEDRAL INCLUSION BODIES OF HELIOTHIS NUCLEAR POLYHEDROSIS VIRUS
Appendix B
Listing of Registration Numbers By Site
/28001AA Beans
011273-00017
/28005AA Corn
011273-00017
/28007AA Cotton
011273-00017
/13020AA Lettuce j
011273-00017 I
/28015AA Peanuts
011273-00017
/28019AA Sorghum
011273-00017
/28023AA Soybeans
011273-00017
/01016AA Strawberry
011273-00017
/26003AA Tobacco
011273-00017
/11005AA Tomato
011273-00017
Issued: 8-19-82
III-107301-4
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