jnmental Prot-
Agency
•n. DC 20460
&EPA
Pesticides
Daminozide
Pesticide Registration Standard
and Guidance Document
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Fact Sheet f:
Dated:
CHEMICAL INFORMATION FACT SHEET FOR DAMINOZIDE
Description of Chemical
Common Name: Daminozide
Chemical Name: Butanedioic acid mono(2,2-dimethylhydrazine),
Succinic acid 2,2-dimethylhydrazide
Trade Name: Alar, Kylar, SADH, B-nine, B-995, aminozide,
EPA Shaughnessy Code: 035101
Chemical Abstracts Service (CAS) Number: 1596-84-5
Pesticide Type: Plant Growth Regulator
Chemical Family: Amino Acid Derivative
U.S. and Foreign Producers: Qniroyal and Aceto Chemical
Use Patterns and Formulations
Daminozide is a plant growth regulator registered as a 5
percent water soluble liquid or 85 percent water soluble dry
concentrate formulation. The amount of daminozide that is
applied as a field spray ranges from 0.9 to 6.8 pounds active
ingredient per acre per year, depending of the crop, time of
application and desired effects. Daminozide controls the
vegetative and reproductive growth of orchard crops such as
apples, cherries, nectarines, peaches, prunes and pears. In
addition, daminozide use enhances shorter and more erect
peanut vines or modifies the stem length and shape of
ornamental plants. Other minor uses of daminozide include:
Brussels sprouts (California), cantaloupes (California and
Arizona), grapes, and tomatoes.
Scientific Findings
o Summary Science Statement
Daminozide is a white, water soluble solid. Data indicate that
daminozide has low acute toxicity, low dermal irritation
potential and is neither teratogenic nor mutagenic. Daminozide
and its UDMH contaminant cause oncogenic effects. A tolerance
reassessment cannot be performed at this time. Daminozide
leaches from soil, but is not persistent. Daminozide is net
an acute toxicant to fish and wildlife.
o Chemical Characteristics
Daminozide is a white, crystalline solid with slight to no
odor. Daminozide is soluble in water, methanol and aceto-
nitrile, but insoluble in xylene and aliphatic hydrocarbons.
Daminozide has a melting point range from 154 to 156°C.
Technical daminozide contains at least 99 percent active
ingredient.
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o Toxicological Characteristics
The LD50 and Toxicity Categories for daminozide are: acute
oral ( 8.4 g/kg, IV), acute dermal (>16 g/kg, III), acute
inhalation (>147 mg/kgf IV), primary eye irritation (mild,
none at this time), dermal irritation (mild, IV). Daminozide
does not produce mutagenic or teratogenic effects. Data are
insufficient to judge the effects of daminozide on reproduction.
Daminozide causes oncogenic effects in laboratory animals.
o Physiological and Biochemical Behavioral Characteristics
Data indicate that daminozide is rapidly absorbed through
the leaves, roots and stems. Daminozide is translocated in
plants and can accumulate in roots, fruit, etc. Adequate
methods are available to detect daminozide. A method to
detect the UDMH metabolite down to 1 ppb must be validated
to confirm the presence of UDMH residues in plants. Components
of the final residues have not been adequately identified or
quantified. The majority of daminozide residues ingested by
milk animals is rapidly excreted in the urine and feces.
o Environmental Characteristics
Degrades in water to unsymmetrical 1,1-dimethylhydrazine
(UDMH), a known oncogen. Daminozide appears to resist
photodegradation, but is degraded by soil microorganisms.
Daminozide appears to leach, but since it does not persist
in soil, the potential for ground water contamination is
small. Daminozide does not bioconcentrate in fish nor does
it accumulate in rotational crops.
o Ecological Characteristics
Daminozide has low acute toxicity to fish and terrestrial
wildlife. No data are available to assess the ecological
hazard from the UDMH hydrolysis product/contaminant. Problems
with Endangered Species: None known at this time.
o Tolerance Assessment
A final reassessment of all tolerances cannot be made at this
time until the data gaps specified by the Standard are filled.
o Problems with Use
Extended storage of solutions of daminozide result in excessive
hydrolysis of the active ingredient to UDMH.
Regulatory Position & Rationale
o Use Clasiification
Daminozide is classified as a General Use Pesticide.
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o Use Restrictions
None.
o Unique Warning Statements
Solutions of daminozide must be used within 24 hours after
preparation.
o Benefit Analysis
Approximately 825,000 pounds of daminozide are produced annually
with apples and peanuts accounting for 600,000 pounds and
225,000 pounds of the annual usage, respectively. Without
daminozide, short term revenue losses are projected to range
up to $30 million annually for apples and from $4.3 to $10.7
million annually for peanuts.
o Risk Analysis
Significant exposure to daminozide and UDMH can occur via
consumption of raw and processed agricultural commodities
treated with daminozide. The Agency's preliminary estimate
of oncogenic dietary risk for daminozide is high. There are
insufficient data to quantify the oncogenic dietary risk of
UDMH at this time. The oncogenic nondietary risk for daminozide
and UDMH may not be significant.
o Special Review
Registrants of daminozide products are notified, via the
Guidance Document, that daminozide meets the oncogenicity risk
criterion in 40 CFR 162.11(a) and will..undergo a Special
Review. The Agency will not reregister any current products
and it will not register any new products containing daminozide
until Special Review is completed and the Agency has received
commitment to fulfill data requirements.
Summary of Major Data Gaps
Data gaps and time [in months] allowed to perform studies:
toxicology (chronic testing [48], teratology [12], reproduction
[24], general metabolism [12] and mutagenicity [6]), product
chemistry (product identity, analysis and certification of
product ingredients, physical and chemical characteristics)
[6], environmental fate (degradation [6], photodegradation [6],
metabolism [24], mobility 16], dissipation [24], accumulation
[24] and reentry [24], residue chemistry (metabolism in
plants and animals [12], analytical methods and residue data
[12], residue data [12]), and .ecological effects (avian and
mammalian testing and aquatic organism testing) [48].
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Contact Person
Robert Taylor, PM 25
Registration Division (TS-767C)
Environmental Protection Agency
401 M Street, SW
Washington, D.C. 20460
(703)-557-1800
Disclaimer
The information presented in this Chemical Information Fact
Sheet is for informational purposes only and may not be used
to fulfill data requirements for pesticide registration and
reregistration.
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GUIDANCE FOR THE INTERIM
REGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
DAMINOZIDE
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C.~ 20460
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Acknowledgments
Michael F. Branagan Review Manager (SRB)
Ingrid Sunzenauer Review Manager (SRB)
William Boodee Product/Residue Chemist (BED)
Reto Engler Environmental Health Scientist (HED)
Dennis McLean Wildlife Biologist (HED)
Bertram Litt Statistician (HED)
Pat Ott Environmental Chemist (HED)
Richard Petrie Agronomist (BUD)
Esther Saito Science Integration Staff (HED)
Henry Spencer Toxiologist (HED)
Robert Taylor Product Manager (FHB)
Edward Weiler Economist (BUD)
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TABLE OF CONTENTS
Introduction 1
I. Regulatory Position 4
II. Requirement for Submission of Generic Data 38
III. Requirement for Submission of Product-Specific
Data 41
IV. Submission of Revised Labeling and Packaging
Information 42
A. Label Contents
1. Product Name
2. Company Name and Address
3. Net Contents
4. Product Registration Number
5. Producing Establishment
Registration Number
6A Ingredient Statement
6B Pounds Per Gallon Statement
.7. Front Panel Precautionary Statements
7A Child Hazard Warning Statements
7B Signal Word
7C Skull and Crossbones and Word Poison
7D Statement of Practical Treatment
7E Referral Statement
8. Side/Back Panel Precautionary Labeling
8A Hazard to Humans and Domestic Animals
8B Environmental Hazard
8C Physical or Chemical Hazard
9 Misuse Statement
10A Storage and Disposal Block
10B Directions for Use
B. Collateral Information
V. Instructions for Submission 47
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APPENDICES
I Bibliography
II FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1
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
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g), as amended in 1978, directs tPA to
reregister all pesticides as expeditiously as possible. Each
registrant of a manufacturing use product of the active
ingredient who 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 pesti-
cide 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. A thorough review of the product performance
data base has not been performed for all pesticides, in
keeping with the efficacy waiver policy for non-public health
uses of pesticides. 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
limitations, or other requirements 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 end-use (formulated) products that contain the active
ingredient. If we find serious concerns, we will bring
end-use 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 registrants submit data that will answer our questions
regarding the hazard that may result from the intended use of
the pesticide under review. Further, it is the Agency's policy
under §3(c)(2)(B) that these data are not required to be
submitted by those registrants who qualify for the formulator1s
exemption [FIFRA §3(c)(2)(D)]. Normally, this means that the
registrants who are responsible for filling the data gaps are
the manufacturing-use product producers (basic suppliers of
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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 regist-
rant'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 the Agency to discontinue the
registration of any of your products subject to the interim
registration requirements of this Guidance 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 registration(s). If you decide to
maintain your product registration(s), you must provide the
information described in the following pages within the time-
frames outlined. EPA may issue a notice of intent to cancel
or suspend the registration of any currently registered
product or deny any application for registration of a product
if you fail to comply with the requirements set forth in
this Guidance Document for Interim Registration
This Guidance Document for Interim Registration will be
supplemented by EPA with additional information about
compliance with data support requirements. In Monsanto v.
Acting Administrator, EPA was enjoined from implementing
$3(c)(l)(D) of FIFRA. EPA has decided that as long as this
injunction is in effect, it will, for most pesticides, proceed
with the requirements in this Guidance Document for Interim
Registration which do not require compliance with the provisions
of S3(c)(l)(D). EPA will not require current registrants to
apply to amend their product registrations to make changes
in the labeling, packaging, or composition for this chemical
at this time. The Agency will supplement this Document for
Interim Registration with additional guidance when this
litigation concludes. Failure to comply with the provisions
of the subsequent guidance may also result in issuance by
EPA of an intent to cancel the affected product registration(s).
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 adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) FOR MAINTENANCE
INTERIM REGISTRATION
I.Products Not Qualifying For A
Formulator's Exemption
A.Single Active Ingredient
Products*
These products must obtain
registration by compliance
with the labeling, pack-
aging & data requirements
stated in the Guidance
Document for Interim
Registration.
B.Multiple Active Ingredient
Products
These products will not
be reregistered at this
time. However, generic
data required to continue
the registration of the
active ingredient under
review, as described in
the Guidance Document,
will be required and some
labeling precautions may
also be required.
II.Products Qualifying For A
Formulator's Exemption
Only when additional re-
strictions or labeling are
needed to protect man or
the environment will these
products be subject to the
Registration Standard re-
quirements. Affected
products will be handled
in a variety of ways, in-
cluding but not limited to
the Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also produce a manu-
facturing use product need not obtain interim regiatration,
provided that the registrant fulfills the requirements in
the Guidance Document for Interim Registration. Such end-
-use products are subject to the label changes required for
products in "II" above. If there are no manufacturing-use
products registered by any company, end-use products must
comply with the Guidance Document for Interim Registration.
NOTE; If all registrants in "I" above fail to meet the re-
quirements in I-A and B above, then the registrants in "11"
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 AND RATIONALE
A. INTRODUCTION
This chapter describes the regulatory position of the
Environmental Protection Agency ("the Agency") on daminozide,
based on an evaluation of all registered manufacturing-use
products (MUP's) containing daminozide as the sole active
ingredient. Future requests for registrations of substantially
similar products will be covered by this Standard. Dissimilar
products will require amendments to the Standard. This
Standard provides the rationale for the Agency's position,
the criteria for registration and also discusses labeling
requirements and tolerances.
In developing its regulatory positionf the Agency determines
whether available data indicate that a pesticide has met
the criteria for unreasonable adverse effects found in
Section 162.11(a) of Title 40 of the U.S. Code of Federal
Regulations (CFR). Pesticides meeting these criteria are
candidates for a Special Review, which is a modification of
the intensive risk/benefit analysis known as the Rebuttable
Presumption Against Registration (RPAR) process. The Agency's
determination whether any criteria have been met and its
rationale for any regulatory action are summarized in the
regulatory position of this standard.
"Daminozide" is the accepted common name for butanedioic acid
mono (2,2-dimethylhydrazide) recognized by the American
National Standards Institute. Trade and other names for
daminozide include Alar*-85,^Alar*, SAD 85*, Kylar®-85,
B-nine*-SP, Succinic acid, 2,2-dimethylhydrazide and
N-(dimethylamino)succinamic acid. The Chemical Abstracts
Service (CAS) Registry number is 1596-84-5. The Office of
Pesticides Program's internal control number (EPA Shaughnessy
number) is 035101.
B. USE PROFILE
Daminozide is a plant growth regulator registered as a 5 percent
water soluble liquid concentrate or 85 percent soluble dry
concentrate formulation for use in controlling the vegetative
and reproductive growth of orchard crops such as apples,
cherries, nectarines, peaches, prunes and pears. In addition,
daminozide use enhances shorter and more erect peanut vines
or modifies the stem length and shape of ornamental plants.
Other minor uses of daminozide include: Brussels sprouts
(California), cantaloupes (California and Arizona), grapes,
and tomatoes (pre-harvest treatments are limited to Florida).
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C. REGULATORY POSITION
Based on a review and evaluation of all available data and
other relevant information on daminozide, the Agency has made
the following determinations:
1. Daminozide has demonstrated oncogenic effects in
laboratory animals and is contaminated with and hydrolyzes
to unsymmetrical 1,1-dimethylhydrazine (UDMH), a
known animal oncogen. Registrants of daminozide
products are hereby notified that daminozide has met
the oncogenicity risk criterion in 40 CFR 162.11(a) and
will undergo a Special Review. A Notice announcing
the initiation of a Special Review will be published
in the Federal Register.
2. The oncogenic dietary risk of daminozide is high.
Additional oncogenic risk occurs as a result of UDMH
dietary exposure. The continued use of daminozide may
cause unreasonable adverse effects on the environment.
The oncogenic nondietary risk of daminozide and UDMH
does not currently appear to be sufficiently high to
cause concern for the Agency.
3. The Agency will not reregister any current products
and it will not register any new uses of daminozide
until the Special Review is completed and the Agency
has received a commitment to fulfill all data requirements,
4. Registered manufacturing-use products containing
daminozide as a sole active ingredient may be sold,
distributed, formulated and used in the United States,
subject to the terms and conditions specified in this
Standard. Registrants with products that do not conform
to this Standard must apply to amend the Standard in
order to obtain interim registration. Mixtures and
end-use products containing daminozide are covered
under this Standard for the purposes of labeling. The
use patterns of the end-use products are considered
for purposes of determining generic data requirements
for daminozide.
5. Registrants not qualifying for a formulator exemption
must provide or agree to develop all data specified in
the tables of this Standard to maintain existing
registrations. The Agency may amend this Standard or
initiate further regulatory actions after it has reviewed
the submitted data and concluded the Special Review.
All data must be generated according to the Good
Laboratory Practices specified in 48 FR 53946. All
data must be initiated as soon as possible after
receipt of the Guidance Document. Registrants must
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notify the Agency of any information which indicates
possible adverse effects, as specified under Section
6(a)(2) FIFRA.
D. REGULATORY RATIONALE
At this time, the Agency has determined that it will not
reregister existing use patterns of daminozide for the
following reasons:
1. Daminozide has demonstrated oncogenic potential in
laboratory animals. Additionally, daminozide is
contaminated with and hydrolyzes to UDMH, a chemical
known to cause oncogenic effects in laboratory animals.
2. Significant exposure to daminozide and UDMH can occur
via consumption of raw and processed agricultural
commodities treated with daminozide as well as during
application.
3. Dietary risk estimates for daminozide and UDMH indicate
that an unacceptable risk may exist from consumption of
raw and processed agricultural commodities treated with
daminozide.
4. There are no data to establish reentry exposure to
daminozide and UDMH for individuals entering areas
treated with daminozide. However, the Agency has
established an interim 24 hour reentry interval. The
Agency will evaluate the reentry interval after it has
reviewed data required by this standard.
5. Available data are 'insufficient to fully assess the
environmental fate of daminozide and UDMH. A complete
environmental fate assessment will be performed after
the data, required by this document, are reviewed by
the Agency.
6. There are insufficient data to characterize the toxic
effects of the end-use products containing daminozide
and UDMH to aquatic organisms. A complete hazard
assessment will be performed after additional ecological
effects data are submitted to the Agency.
7. Data available on both human or wildlife poisoning
incidents through the Pesticide Incident Monitoring
System (PIMS) through July, 1980 indicate only a single
report/ a case of skin irritation. PIMS data, though,
provide no information on chronic health effects from
exposure to this or other chemicals.
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E. CRITERIA FOR INTERIM REGISTRATION UNDER THIS STANDARD
All manufacturing-use products which contain daminozide as
the sole active ingredient are subject to this Standard. All
products subject to this Standard must either comply with
the acute toxicity limits, product composition and use pattern
requirements listed in Section F or submit data and a
justification to amend the Standard to encompass such products.
The Agency will not reregister any current products and it
will not register any new products until the Special Review
has been completed and the Agency has received commitments to
fulfill all data requirments.
F. ACCEPTABLE RANGES AND LIMITS
1. Product Composition
Technical grade products must contain at least 99 percent
daminozide as the sole active ingredient. All manufacturing-
use product formulations must be fully described with an
appropriate certification of limits. Any manufacturing-use
daminozide product not meeting these requirements will be
consider a new product and will not be reregistered until
completion of the Special Review and the Agency has received
a commitment to fulfill all data requirements.
2. Acute Toxicity Limits
Technical grade and manufacturing-use products containing
daminozide must be labeled according to the following acute
toxicity categories: Acute Oral (IV), Acute Dermal (III),
Acute Inhalation (IV) and Primary Dermal Irritation (IV).
3. Use Patterns
Manufacturing-use products containing daminozide must be
labeled for formulation only into end-use products for use as
a growth regulator used on apples, cherries/ peanuts,
nectarines, peaches, prunes, pears, brussel sprouts (California),
cantaloupes (California and Arizona), grapes, tomatoes
(Florida) and ornamentals.
G. REQUIRED LABELING
All technical grade, manufacturing-use and end-use products
containing daminozide must bear appropriate labeling as
specified in 40 CFR 162.10. The following labeling requirements
apply to technical, manufacturing-use and end-use products.
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1. Manufacturing-Use Product Statements
a. Use Patterns
Products intended for formulation into end-use products must
bear the following statement:
"For formulation only into end-use plant growth regulator
products intended for use on apples, cherries, nectarines,
peaches, prunes, pears, brussel sprouts (California),
cantaloupes (California and Arizona), grapes, tomatoes
(Florida), peanuts and ornamentals."
"Avoid breathing dusts and contact with skin."
All products must bear the following statements:
"Each formulator is responsible for obtaining EPA
registrations for its formulated product(s)."
b. General Warning
"Do not discharge into lakes, streams, ponds, or public
waters unless in accordance with NPDES permit. For
guidance, contact your Regional Office of the EPA."
2. End-Use Product Statements
"Do not contaminate water by cleaning of equipment
or disposal of wastes. Do not apply directly to
water or wetlands."
"Do not allow spray solution to touch skin and wear
protective clothing to protect hands, arms and legs
both when diluting and applying this product."
"Do not reenter treated areas until 24 hours after
application, unjess wearing protective clothing."
"Avoid breathing dusts. Wear a protective mask
during mixing/loading operations."
"Use spray and stock solutions within 24 hours. Do
not store solutions. Immediate use is appropriate,
if another component is added to spray mixture."
H. TOLERANCE REASSESSMENT
A listing of the tolerances in the United States for residues
of daminozide in or on raw agricultural commodities may be
found in 40 CFR 180.246, in processed foods may be found in
21 CFR 193.410 and in animal feeds when applied to growing
crops may be found in 21 CFR 561.360. There are no Codex
entries for residues of daminozide.
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The several registration and FIFRA § 3(c)(2)(B) tolerance
data requirements which are outstanding and the few available
residue data preclude a final reassessment of all daminozide
tolerances at this time. Until these data gaps are filled,
the Agency is unable to satisfactorly estimate the contribution
of actual residues of daminozide and its UDMH contaminant/
hydrolysis product to the diet.
I. PRELIMINARY ANALYSIS OF CURRENT BENEFITS AND RISKS
1. Current Benefits Review
a. Introduction
Under Section 3 of FIFRA, the Agency's decisions on pesticide
use must consider benefits as well as risks. In an attempt
to quantify the benefits from the use of daminozide as a
growth regulator, biological and economic data were compiled
on apples and peanuts, the two predominant use sites.
b. Usage Estimates by Site
Approximately 600,000 pounds active ingredient of daminozide
are applied to 125,000 to 130,000 apple acres (25 percent of
U.S. apple acreage), with usage concentrated on fruit intended
for the fresh market. For peanuts, about 225,000 pounds
active ingredient of daminozide are used for 250,000 acre
treatments of which 175,000 to 180,000 acres are in the eastern
U.S..
For all other registered sites, the estimated annual usage is
35,000 pounds active ingredient, or approximately 4 percent
of the total national usage of daminozide. No benefits were
estimated for daminozide use on these latter sites. It should
not be assumed that no benefits from daminozide uses are
derived at these minor sites simply because they are not
included in this current benefits evaluation.
c. Summary of Findings
i) Apples
Daminozide, formulated as an 85 percent soluble dry concentrate,
is used as a single application foliar spray for apples. The
registered application rates range from 3.4 to 6.8 Ibs/A.I./
acre/yr in 400 gallons of water/acre for "Spring" treatment,
2.6 to 5.1 Ibs/A.I./acre/yr in 400 gallons of water/acre for
"Mid-Season" treatment, and 1.7 to 5.1 Ibs/A.I./acre/yr in
400 gallons of water/acre for "Summer" treatment. The types
of desired plant growth regulator effects determine the
selected seasonal timing of applica*ion. Tree size and vigor
are factors that determine the specific rate selected within
the range of the application rates.
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Daminozide is currently the only registered apple plant growth
regulator that provides all of the following multiple effects:
o Increases fruit color (on red varieties),
o Delays fruit maturity (ripening), thereby extending
the harvest period,
o Prevents preharvest drop,
o Maintains fruit firmness, thereby reducing handling
and storage bruises,
o Delays development of watercore primarily in Red
Delicious and Stayman varieties up to 7 days,
o Reduces scald, weather check, bitterpit, cork spot,
fruit cracking, apple size and vegetative growth,
o Promotes flower bud initiation in the following
spring, thereby, increasing return blossoms,
fruit set and subsequent yields.
Other registered apple plant growth regulators with similar,
but limited claims include:
o NAA - Prevents preharvest fruit drop of short duration.
Application must be repeated at 5 to 10 day intervals
and be delayed until just prior to harvest.
o Silvex - Increases red color and prevents preharvest
fruit drop, as does daminozide. Silvex, however,
accelerates fruit ripening and softening, necessitating
harvest within 2 weeks after application to prevent
overripening of the fruit. Additionally, silvex may
not be applied closer than 14 days prior to harvest.
In addition, this use of Silvex is subject to a
Notice of Intent to cancel registrations. Silvex is
currently undergoing cancellation hearings.
o Ethephon - Promotes red color development and flower
initiation on young non-producing trees, as does
daminozide. Major disadvantages include accelerated
fruit ripening and, in the mid-Atlantic states,
accelerated watercore development. Ethephon is often
tank mixed with daminozide to offset these undesirable
effects. The use of ethephon alone is not recommended
for the storage of fresh fruit.
o Diphenylamine - Prevents scald development if applied
as a post-harvest spray or dip within 7 days prior to
storage. This chemical is considered to be more
effective than daminozide for scald control.
10
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o Ethoxyquin - Prevents scald development if applied as
a post-harvest spray or dip prior to storage. This
chemical is considered to be more effective than
daminozide for scald control.
Daminozide offers a major advantage for application timing
over NAA or silvex for pre-harvest drop control. Daminozide
may be applied early enough in the season to afford assurance
against apple drop in the time period prior to harvest, a
time period before NAA and silvex may be applied to the crop.
Daminozide is currently the only registered plant growth
regulator that provides the specific following benefits:
o Delays fruit maturity,
o Maintains fruit firmness,
o Delays watercore development (primarily in the
raid-Atlantic states),
o Reduces apple size (used on the Rome Beauty variety
to accomodate coring and peeling machine processing).
Without daminozide, fresh market Red Delicious and Mclntosh
apple producers would incur substantial losses in the short
run, with possible losses in net revenue ranging up to $30
million per year. U.S. farm value of fresh apple production
was approximetley $597 million in 1982. Of the above loss,
growers of Mclntosh apples would lose up to $18.83 million
in annual net revenue on 37,300 affected acres. Losses of
this intensity suggest either that alternative apple varieties
would be planted over a prolonged period of time, or that
some unknown proportion of Mclntosh producers would leave
the apple industry.
Short term annual income losses on 70,000 affected acres of
Red Delicious apples were estimated at $11.22 million, or
about $159 per acre. Consumers could encounter reduced
quality in fresh apples, as well as a shorter term duration
of fresh fruit availability due to reduced apple storage
life. Alternatively, a greater quantity of processed apples
could be expected at lower than current prices.
ii. Peanuts
Daminozide, formulated as an 85 percent soluble dry concentrate,
is spray applied over-the-top-of peanuts to produce shortened,
more erect vines, and to enhance green coloration as well as
yields. One to six applications are applied per growing
season, with total seasonal active ingredient usage ranging
from 0.80 to 1.3 pounds per acre, while current use practices
indicate one to three applications per season. Current
permissible treatment requires a 30 day preharvest interval.
11
-------
The total number of applications in a given season is variable
and often dependant on factors that influence rapid vine growth
(e.g. rainfall, irrigation practices and peanut variety). No
other growth regulators are registered for this use. Without
daminozide, U.S. peanut growers (mostly in the southeast)
could be expected to sustain short term reductions in net
revenue, ranging from $4.3 to $10.7 million annually, or
from $23.95 to $59.50 per impacted acre. U.S. farm value of
peanut production was $856 million in 1982. While impacts
of this intensity could represent a substantial financial
impact to affected growers, total U.S. production could
decline from 1.0 to 1.7 percent, causing no appreciable
effect on farm or retail prices. Moreover, it is likely
that any serious production shortfalls could be alleviated
by increases in allowable production in that poundage quotas
will be in effect through 1985.
d. Limitations of Analysis
The specific site analyses provide an overview of use/usage,
the availability and efficacy of alternative controls, and
the likely economic consequences in the absence of daminozide
for only the most important sites (e.g. apples and peanuts).
These analyses are preliminary, were developed with data
readily available to the Agency, and do not quantify all of
the "enhancement effects" attributable to daminozide. These
analyses are subject to future revision by the Agency.
2. Preliminary Risk Analysis
a. Introduction
The Agency has completed its review of the data base for
daminozide and has concluded that daminozide and its UDMH
hydrolysis product are oncogenic in laboratory rats and mice.
One study indicated that feeding of daminozide caused
adenocarcinomas and leiomyosarcomas of the uterus in female
rats, hepatocellular carcinomas in male mice, and alveolar/
bronchiolar carcinomas and adenomas in male and female mice
and female rats (NCI, 05007997). In a second study,
administration of daminozide in drinking water resulted
in statistically significant incidences of blood vessel
tumors and lung tumors in both male and female mice, as well
as a significant incidence of kidney and liver tumors in the
male mice (Toth, 05009679). Analysis of the drinking water
in this latter study indicated that the UDMH hydrolysis
product increased as a function of time. In a third study
(Toth, GS032001), administration of drinking water containing
UDHM resulted in statistically significant incidences of
blood vessel and lung tumors in both male and female mice.
Kidney and lung tumors were also noted in this study, but at
a lower rate than the blood vessel and lung tumors.
12
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The Agency is concerned with the presence of unsyrametrical
1,1-dimethyIhydrazine (UDMH) that is associated with the use
of daminozide. UDMH causes oncogenic effects in laboratory
animals. UDMH has demonstrated mutagenic activity in both the
presence and absence of metabolic activation. UDMH is a
contaminant in-technical products and formulated products.
Hydrolysis of formulated products, as diluted for use can
form additional UDMH. Hydrolysis of daminozide residues to
UDMH, following the boiling of apples, was first identified
and reported by Newsome (1980, MRID 005021600). UDMH was
also found in apple juice.
The Agency currently has insufficient data to make a complete
assessment of risk from daminozide and UDMH. The Agency
requested and received commitments to generate studies to
address risk, via a request under section 3(c)(2)(B) FIFRA
dated August 25, 1983. The requested data include:
o In-vitro hydrolysis study simulating the conditions
in the human stomach to determine the mechanism and
rate of conversion of daminozide to UDMH,
o In-vivo radiolabeled metabolism study in an
appropriate species with a stomach pH similar to the
human,
o Residue study on apples treated with daminozide,
o €14 plant metabolism study to determine the fate of
daminozide and UDMH in plants,
o Residue study on all raw agricultural commodities
listed in 40 CFR 180.246, and for each food or feed
listed in 21 CFR 193.410 and 561.360,
o A study to examine conversion of daminozide to UDMH
during food preparation and processing,
o Cj4 metabolism study in ruminants and poultry,
o Tiered animal residue study in ruminants and-
poultry, and
o Tiered in vitro and in vivo study to determine
the fate of bound residues.
The Agency has evaluated residue data, the only data submitted
under § 3(c)(2)(B) FIFRA. The Agency has concluded that these
few residue data do not adequately reflect the amount of UDMH
formed in apples, apple sauce or apple juice from the maximum
recommended and registered use of daminozide on apples and
other raw agricultural commodities because data are not
available to allow the Agency to determine whether daminozide
was applied at the maximum registered application rate. These
and other data will be discussed in the Special Review,
13
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b. Dietary Exposure
i) General Assumptions
The estimated dietary exposure of humans to pesticide residues
from registered uses is a function of several factors:
o The pesticide residues remaining in or on a
commodity (in ppm, usually at the established
tolerance level) to calculate the Theoretical
Maximum Residue Contribution (TMRC) to the diet,
o The mean percentage of a commodity in a daily diet
of 1.5 kg (food factor),
o The assumed average body weight of a person is 60 kg.
When these factors are substituted into a formula, human
exposure to pesticide residues in a commodity is found in
terms of mg of pesticide per kg of body weight per day.
ii) Daminozide
The Agency has estimated the potential dietary exposure to
daminozide by the U.S. population from treated fruits and
vegetables. In making these estimates, the Agency had to
choose between two basic approaches. The first approach was
to assume that the national population might be exposed to
the average of residue levels actually measured in field
tests. The second was to assume that the U.S. population
could be exposed to the highest residues of daminozide that
would be legally permissible, which would be at the tolerance
level, and to calculate the maximum residue exposure for
each individual. The available data are not adequate to
calculate actual residue levels. The dietary exposure
assessment, therefore, has been based on the current tolerances
for daminozide.
The Agency's dietary estimates on raw agricultural commodities
assume equal distribution of treated crops among the U.S.
population and an average daily consumption of fruit by
individuals. An individual's exposure could, of course, vary
considerably depending upon eating habits and geographic
location. For example, in some areas all of the apples sold
may have been treated with daminozide or a person may consume
more than the average portion of fruit in his daily diet.
But since the reverse may occur as well, in some areas none
of the fruit sold may have been treated or a person may eat
less than the average portion of fruit, the values are
considered representative for the total U.S. population over
a lifetime.
14
-------
The human dietary exposure estimates to daminozide are based
on the established tolerance levels (40 CFR, 180.246) and
are estimated to be 3.92 mg/day (0.0655 mg/kg body weight
for a 60 kg person). A summary of the Agency's dietary
exposure analysis for daminozide is presented below.
DIETARY EXPOSURE TO DAMINOZIDE1/
Food Factor Daily Intake
Crop Tolerance (% of Daily (mg/1.5 kg
ippm) Diet)2/ diet/day)
Cherries
Plums(incl.
prunes)
Tomatoes
Apples
Nectarines
Peaches
Peanuts
Brussels
Sprouts
Pears
Grapes ( not
raisins)
Melons
Peppers
Meat (incl.
poultry)
Eggs
Milk
55
50
40
30
30
30
30
20
20
10
3
1
0.2
0.2
0.02
0.10
0.13
2.87
2.53
0.03
0.90
0.36
0.03
0.26
0.45
2.00
0.12
13.85
2.77
28.62
TOTAL
0.08
0.10
1.72
1.14
0.01
0.40
0.16
0.01
0.08
0.07
0.09
0.00
0.04
0.01
0.01
3.92
JL/ Based on tolerance levels,
2/ Mean daily percentage.
iii) UDMH
There are few data on UDMH residues in or on raw agricultural
commodities in the diet. Of major concern to the Agency is
the potential for breakdown of daminozide residues to UDMH,
a carcinogen, A 1980 study (Newsome, MRID 005021600) indicated
that boiling of apples treated with daminozide resulted in a
significant fraction of the daminozide residues coverting to
UDMH. This study indicates that 5.1 percent of daminozide
applied to the apples converted to UDMH. The measurement of
field treated apples containing a lower level of daminozide
showed an even higher conversion level to UDMH of 7.7 percent.
The Agency has reviewed residue data submitted to-date.
Daminozide and UDMH residues in processed apple juice ranged
from 0.5 to 10.5 ppm and 4.0 to 220 ppb, respectively.
Daminozide and UDMH residues in processed apple sauce ranged
from 0.5 to 10.9 ppm and 4.9 to 383 ppb, respectively. The
combined data to-date indicate that daminozide residues in
15
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apples will breakdown to UDMH by cooking and processing
procedures. Daminozide residues in processed apples have
ranged from 1.0 to 21 ppm.
Additional market basket studies of commercially processed
apple sauce detected daminozide and UDMH ranging from <1 ppm
to 1.5 ppm and <1 ppb to 69 ppb, respectively. Analysis of
commercially processed apple juice detected daminozide and
UDMH ranging from <1 ppm to 1.6 ppm and <1 ppb to 51 ppb,
respectively. The results of this "market basket survey"
indicate the presence of daminozide and UDMH at significant
levels.
The Agency is concerned about UDMH and darainozide dietary
exposure to special groups of individuals (especially young
children) who consume large quantities of apple products.
Exposure of these types of individuals will be an area of
discussion in the Special Review.
c. Non-Dietary Exposure
i) General Assumptions
Daminozide is applied primarily by air blast equipment to
orchards, by ground boom equipment to vegetable crops and by
a hand carried three-gallon power sprayer in greenhouses.
Available data indicate that daminozide leaches, but is not
persistent. Thus, exposure of humans to daminozide through
contamination of ground water is unlikely. Likewise, exposure
to aquatic organisms through runoff and leaching is considered
unlikely. Exposure of workers to daminozide occurs by dermal
and inhalation routes during mixing, loading, and spraying.
ii) Daminozide
Worker exposure was measured in two studies submitted by
Uniroyal Inc. (MRID GS0032012 and MRID GS0032024) using
procedures developed by Durham and Wolfe (1962, MRID GS0032015)
for the assessment of pesticide exposure during agricultural
operations, worker exposure was measured at six apple
growing sites, three greenhouses and one peanut growing
site. Daminozide was mixed with water prior to use and
applied under actual use conditions by volunteer workers.
Worker exposure in apple orchards was measured using both
concentrate and dilute sprays of daminozide at several
different application rates including the maximum label
rate. Exposure values for apple workers were calculated
from these studies. The exposure estimate for peanuts is
based on only one sample and reflect an application rate
less than the maximum recommended rate. Applicator exposure
to daminozide in greenhouses was also estimated.
16
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The following assumptions were made to calculating worker
exposure for daminozide:
o All daminozide collected on respirator pads was
inhaled by the worker,
o Workers wore a short-sleeved shirt and long pants
so that dermal exposure was the sum of exposures of
unprotected skin (face, neck, forearms and hands),
o Results of analysis of shoulder pad (in ug/cm2)
were used to estimate facial exposure based on 650
cm2 of facial surface area,
o Results of analysis of back and chest pads were used
to estimate neck exposure based on a surface area
of 150cm2 for front of neck and 110cm2 for back
of neck.
o Exposure to forearms was calculated based on 1210cm2
surface area,
o Exposure to hands was the sum of analysis (in mg) of
two handwashings following application.
The following table presents the Agency's estimate of non-
dietary exposure.
17
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I/
WORKER EXPOSURE TO DAMINOZIDE
Unit
Exposure
Dermal
(mg/hr)
Inhalation
(mg/hr)
Total
(mg/hr)
Time
(hr/yr)"
Exposure2/
mg/kg/yr
I/
Apples
Max
Ave
Min
Peanuts
77.6
33.7
12.4
4/
5/
2.3
0.0169
0.0029
0.0002
0.0011
77.6
33.7
12.4
2.31
4.8
4.8
4.8
6.0
6.0
6.0
5.3
2.3
0.9
6.-7
2.9
1.1
18 - 72
0.6 - 2.4
Ornamentals
Max
Ave
Min
8.5
7.1
5.5
0.0043
0.0016
N.D.
8.5
7.1
5.5
27
27
27
3.3
2.7
2.1
jVBased on Uniroyal applicator exposure studies [Ball and
Cununings (MRID GS032012), Ball (MRID GS032024)] uncorrected
for absorption. Assume applicator wears shoes, socks, long
trousers, a shortsleeved open-necked shirt, but no hat or
gloves.
^/Assume a person weighs 70 kg.
^/Exposure time based on Stone (MRID GS0032021). The low
figure represents treatment of 50 acres of apples (150
gallons/acre) using a concentrate sprayer. The high figure
represents treatment of 50 acres of apples (400 gallons/acre)
using a dilute solution sprayer.
^/Exposure time based on Russell (MRID GS0032018). The low
figure represents three treatments per year, 6 hours per
treatment to an average 53 acre peanut farm. The high
figure represents three treatments per year, 24 hours per
treatment to a common size 200 acre peanut farm.
Vfixposure time based on Petrie (MRID GS032014). This figure
represents an average of three crops per year with two
treatments per crop.
iii) UDMH
Exposure to the impurity UDMH has been calculated based on
the estimate by Von Schmeling (MRID GS0032003) that technical
daminozide contains 0.005 percent UDMH. The dermal exposure
estimates for applicators are presented in the following
table and were calculated by multiplying the corresponding
values from the field exposure study by 5xlO~5 (the percent
of UDMH expressed as a decimal). As inhalation exposure is
negligible when compared to dermal, it has not been estimated.
These exposure values do not account for any UDMH formed as
a result of hydrolysis of daminozide in the spray tank.
18
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WORKER EXPOSURE TO UDMH FROM PRODUCT IMPURITY
Crop
Exposure
(mg/kg/yr)
Apples
Max
Ave
Min
A
3.5x10 4
1.0xlO~4
5.0xlO~5
- 3.0x10 4
- l.OxlO'4
- 6.0xlO~5
Peanuts
Ornamentals
Max
Ave
Min
3.0xlO-5 - 1.2xlO~4
2.3xlO~4
1.0xlO~4
l.OxlO"4
Exposure to UDMH due to hydrolysis of daminozide after mixing
has also been estimated using the results of Wright (1981,
GS0032022). These estimates give some indication of exposure
to UDMH for applicators as a result of hydrolysis of daminozide,
The concentration of UDMH during spraying is the average of
UDMH level present at the beginning of spraying and UDMH
level present at the end of spraying. For both apples and
peanuts daminozide is generally mixed in the spray tank and
applied immediately.
If a 500 gallon spray tank were used in an apple orchard, a
concentrate sprayer (150 gallons per acre) would be refilled
every 30 minutes and dilute sprayer (400 gallons per acre)
would be refilled every 25 minutes while spraying. For
spraying peanuts a 150 gallon tank capacity sprayer delivering
10 gallons per acre would be refilled every 1.7 hours.
Based on the data from the hydrolysis study by Wright, the
concentration of UDMH which is produced from the hydrolysis
of daminozide can be estimated from the equation X = A(l-e-KT)
where:
o A is the concentration of daminozide at time 0,
o K is the rate constant for hydrolysis = 1.2 x 1~4,
o T is the number of hours after addition of water
to the daminozide powder, and
o X is the concentration of UDMH.
Current label directions for greenhouse application state:
"After mixing, allow to stand for one hour or so before
using." It is assumed that the daminozide solution is allowed
to stand one and one-half hours before spraying begins and
spraying takes one half hour. Then the concentration of UDMH
19
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during spraying is the average of UDMH levels present at one
and one half hours after mixing and 2 hours after mixing. The
Agency believes that longer times will cause higher concentrations
of UDMH to form in the spray solution and result in higher risk.
The following table summarizes estimates of worker exposure
to UDMH.
WORKER EXPOSURE TO UDMH DUE TO HYDROLYSIS1/2/3/
Crop
UDMH Concentration(ppm)
Initial Final Average
Exposure
(mg/hr) (hr/yr) (mg/kg/yr)
Apples (Dilute Spray)
2,500 ppm 0 0.075 "0.038
Apples (Concentrated Spray)
5,000 ppm 0 0.3 0.15
5xlO~4 9.9 7.1xlO~5
7.8 l.lxlO~4
Peanuts
10,000 ppm
Ornamentals
3,000 ppm
7,500 ppm
2.0 1.0
0.54 0.72 0.63
1.3 1.8 1.6
2xlO~4 72
1x10-3
2xlO-3
27
8
2.0xlO~4
3.9xlO-4
2.3xlQ-4
JL/The average UDMH concentration was used to calculate exposure.
^/Exposure was calculated for a 70 kg person.
^/Exposure times are those used for daminozide exposure
estimation.
The total amount of worker exposure to UDMH is the sum of
exposure to both impurity and hydrolysis. Workers applying
daminozide in apple orchards could be exposed to UDMH ranging
from IxlO"4 mg/kg/year to 5xlO~4 mg/kg/year. While applying
daminozide to peanuts, workers could be exposed to UDMH
ranging from 2xlO"4 to 3xlO"4 mg/kg/year. Workers applying
daminozide in greenhouses could be exposed to UDMH ranging
from 3xlO"4 to 6xlO~4 mg/kg/yr.
c. Risk Estimates
i) Introduction
The Agency's Interim Cancer Assessment Guidelines (41 FR
21402) state that when a chemical is judged to be a potential
human carcinogen, the Agency must estimate its possible impact
on public health at current and anticipated levels of exposure.
The Agency recognizes that the available techniques for
assessing the magnitude of the cancer risk to human populations
based on animal data are, at best, uncertain due to the need to
extrapolate the dose response data to very low dose levels
and to differences in levels of susceptability of animals
and humans. Accordingly, these risk estimates are neither
scientific certainties nor absolute upper limits on the risk
of cancer from the exposure to daminozide and its UDMH
20
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contaminant. Rather, these estimates should be viewed as a
health hazard index that incorporates the degree of carcinogenic
activity and human exposure to daminozide and its UDMH
contaminant/hydrolysis product. The Agency has estimated
risk from exposure to daminozide via the dietary and nondietary
routes.
ii) Risk Assumptions
Ingestion of several of the raw agricultural commodities (e.g.
cherries, plums, tomatoes, apples, peanuts, peaches, pears
and nectarines) may result in exposure to high levels of
UDMH by hydrolysis of daminozide during processing or cooking.
Information concerning the possible hydrolysis of daminozide
to UDMH in the processing or home preparation of fruits and
vegetables bearing residues of daminozide and/or UDMH is
lacking with the exception of the apple commodity. Therefore,
the UDMH dietary risk estimate has been limited to consumption
of apple products.
iii) Summary of Risk Estimates
1) Dietary Risk
The Agency has estimated risk separately for exposure to both
daminozide and UDMH.
A) Daminozide
The Agency's estimate of a risk for daminozide at the
Theoretical Maxium Residue Contribution (TMRC) to the daily
diet is presented below.
DAMINOZIDE DIETARY RISK ESTIMATES
TMRC Exposure0*1:Risk
(mg/kg bw/dy) (mg/kg bw/dy)
I/ 2/
6.53 x 10~2 4.7 x 10"3 3 x 10~4
I/ TMRC exposure = 3.93 mg/dy of daminozide in
a 1.5 kg diet for a 60 kg adult. Exposure
is assumed to be a worst case estimate for
daminozide at tolerance levels.
2/ Estimated potency factor was calculated
using the blood vessel tumors from both sexes
of mice and a one-hit multistage model and
was uncorrected for the shorter lifetime of
the treated animals (MRID 005009679).
21
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B) UDMH
The Agency has insufficient data to estimate the amount of
UDMH which may be present in raw agricultural commodities.
Therefore, no risk estimate for UDMH can be performed at
this time.
The Agency is concerned about UDMH and daminozide dietary
exposure to special groups of individuals (especially young
children) who consume large quantities of apple products.
Dietary risk estimates for processed apples for age groups
between birth and adult (maturity) vary considerably. The
Agency cannot estimate risk from such a relatively short and
varying exposure at this time. However, it should be
recognized that the food consumption for these 1 to 2 year
old age groups are many times greater than those typical for
the 60 kg adults. The risk associated with these types of
individuals will be an area of discussion in the Special
Review.
2) Nondietary Risk
The Agency's estimates of risk from apple orchard application
are presentee below.
APPLICATOR RISK ESTIMATES
Exposure Range I/0*1Risk Range
(mg/kg bw/dy) (mg/kg bw/dy)
Daminozide
1.6xlO-J to 4.7xlO-3 7.5xlO~6 to
1.8xlO~2 8.4xlO-5
1Y Assumes 100 percent absorption.
While few data currently are available on exposure to UDMH
and daminozide, the Agency currently believes that the risk
associated with nondietary exposure to these chemicals may
not result in unreasonable adverse effects. Dermal absorption
of daminozide is expected to be low as this water soluble
chemical has a low fat solubility. Additionally, a dermal
LD-50 study indicates that little, if any, daminozide passes
through the skin.
d. Conclusions
The Agency has made a preliminary determination that orally
dosed daminozide is an oncogen and is contaminated with and
hydrolyzes to UDMH, a known oncogen. Daminozide has exceeded
the oncogenicity risk criterion for Special Review.
22
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Daminozide possesses numerous unique plant growth regulatory
effects for apples. Without daminozide, fresh market Red
Delicious and Mclntosh apple producers would incur substantial
net revenue losses in the short run, ranging up to S30 million
per year. No other plant growth regulators are registered
for use on peanuts. Without daminozide, peanut growers
could be expected to sustain short term reductions in net
revenue, ranging from S4.3 to S10.7 million annually.
The Agency estimates that the dietary risk from daminozide
residues is high. Additionally, the Agency believes that
dietary exposure from UDMH residues will also occur. The
Agency believes that the risk associated with nondietary
exposure to daminozide is less significant, sinc£ data indicate
dermal absorption may be low.
Pending further review, registration of new products and
reregistration of current products containing daminozide
cannot be permitted until the Agency has completed the
Special Review, hss received a commitment to fulfill the
data required by this standard and has reviewed the data
requested by the Agency on Audust 25, 1983 under section
3(c)(2)(B) FIFRA.
23
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DATA REQUIREMENT TABLES
24
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TABLE A
GENERIC DATA REQUIREMENTS FDR DAMINOZIDE
Data Reguiranent
panposition
I/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? When?2/
§158.120 Product Chemistry
Product Identity
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation
of Unintentional
Ingredients
TGAI
TGAI
TGAI
partially
partially
partially
00009540
yes
GS032003,00009511 yes
00009514
V
;
5/
GS032003
GS032040
1/1/V
yes
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis TGAI
62-2 - Certification of Limits TGAI
62-3 - Analytical Methods for TGAI
Enforcement of Limits
partially
partially
partially
GS032040
GS032040
yes
(
yes~
00022043,00009423 yes
00009540,00009511
5/
j/Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ All data must be submitted within 6 months after receipt of the Guidance Document.
3/ A quantitative depiction of the unintentional ingredients, present in the technical material, up to 0.1%
of the total weight have to be provided.
4/ A description of the methodology used in the identification and/or quantification of the unintentional
ingredients in the registered technical material should be provided.
S/ Data are available from Uniroyal Chemical, but no data are available from Aceto Chemical Company for this
specific data requirement. Aceto Chemical must submit this data.
25
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TABLE A
GENERIC DATA REQUIREMENTS FOR QAMINOZIDE
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
NO or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIFRA Section
3(c)(2)(B)? When?2/
Physical and Chemical Characteristics
63-2 -
63-3 -
63-4 -
63-5 -
63-7 -
63-8 -
63-9 -
63-10
63-12
Color
Physical State
Odor
Melting Point
Density, Bulk Density,
or Specific Gravity
Solubility
Vapor Pressure
- Dissociation Constant
-DH
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
partially
partially
partially
partially
no
partially
no
partially
partially
00009540
00009540
00009540
00009540
00009540
00009540
00009540
yes
yes
3/
yes
yes
yes
3/
yes
yes
3/
yes
yes
I/ Composition: TGAI • Technical grade of the active ingredient; PAIRA - Pure active ingredient, radiolabelled;
TEP » Typical end-use product.
2/ All data must be submitted within 6 months after receipt of the Guidance Document.
3/ Data are available from Uniroyal Chemical, but no data are available from Aceto Chemical Company for this
specific data requirement. Aceto Chemical must submit this data.
4/ This data gap pertains to both Uniroyal and Aceto Chemical Corp.
26
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DAMINOZIDE
Data Requirement
Composition
V
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? When?2/
S158.120 (cont'd)
63-13 - Stability TGAI
63-14 - Oxidizing or Reducing TGAI
Action
63-16 - Explodability TGAI
63-17 - Storage Stability TGAI
partially
no
no
partially
00009540
3/
yes
I/
yes
yes
00009511
I/
5
3/
yes
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ All data must be submitted within 6 months after receipt of the Guidance Document.
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; I=Indcor.
3/ No data are available frcm Aceto Chemical Company for this specific data requirement. Aceto Chemical must
submit this data.
J/ This data gap pertains to both Uniroyal and Aceto Chemical Corp.
27
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DAMINOZIDE
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Composition Pattern No or Partially) Citation 3(c)(2)(B)? When?
Data Requirement
§158.130 Environmental Fate
Degradation - Laboratory
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On Soil
161-4 - in Air
Metabolism - Laboratory
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
Mobility
163-1 - Leaching and
Adsorpt ion/Desorpt ion
163-2 - Laboratory Volatility
163-3 - Field Volatility
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TEP
TEP
A
A
Partially
No
NO
Partially
No
No
Partially
No
No
GS032022,00009707 Yes/6 months
3/4/
Yes/6 months
00009707
Yes/6 months
Yes/6 months
V
y
V
00009417,00009708 Yes/24 months"
Yes/24 months
y
V
00009707,00009708 Yes/6 months
Yes/6 months
V
Reserved
5/
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=lndoor.
3/ Analysis for UDMH, hydrazine and 1,1-dimethylnitrosamine required. If radiolabeled studies will be conducted,
nitrogen labeling is preferred.
4/ Analysis to be performed at pH 1, 5, 7 and 9.
V Aged soil must be used in this study. Metabolites must be identified.
6_/ Pending results of the Laboratory Volatility data requirement (163-2).
28
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DAMINOZIDE
Data Requirement
I/ Use 2/
Conposition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? Mien?
Dissipation Studies - Field
164-1 - Soil
164-5 - Soil, Long-term
Accumulation
165-1 - Rotational Crops
(Confined)
TEP
TEP
PAIRA
A
A
165-2 - Rotational Crops (Field) TEP A
165-4 - Fish (Laboratory) TGAI or PAIRA A
165^5 - Aquatic Non-Target TGAI or PAIRA A
Organisms (Field)
Partially
No
Partially
No
Partially
No
00009707,00009577 Yes/24 months"
I/
Reserved
3/
00009726
Yes/24 months
6/
5/
00009725
Reserved
j
Reserved
£
Reserved
8/
Subpart K
Reentry
TEP
No
Yes/24 months"
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabe.Ued;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Analysis for UDMH required in this study.
4/ Requirement for this study depends on results of the Soil Dissipation data requirement (164-1).
J5/ Metabolite identification required.
6/ Requirement for this study depends on results of the Confined Rotational Crop data requirement (165-1).
7/ Requirement depends on results of octanol/water coefficient. If required, metabolite identification
in fish required and analysis of water for UDMH is required.
8/ Requirement for this study depends on results of the Fish Accumulation data requirement (165-4).
9/ An interim reentry interval of 24 hours is required until data have been reviewed by the Agency. Registrants
must submit foliar dissipation data.
29
-------
GENERIC DATA REQUIREMENTS FOR DAMINOZIDE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? When?
S158.135 Toxicology
Acute Testing
81-1 -
81-2 -
81-3 -
81-4 -
81-5 -
Oral LD50 (rat)
Dermal LD50
Inhalation LD50 (rat)
Primary Eye Irritation
Primary Dermal Irritation
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,F
A,B,F
A,B,F
A,B,F
ArB,F
Yes
Yes
Yes
Partially
Yes
00009737
00009737
00009737
00009679
00009682
No
No
NO
Yes/6 Months
No
Subchronic Testing
82-1 - 90 Day Feeding (rodent) TGAI
Chronic Testing
83-1 - Chronic Toxicity TGAI
Two Species <
(rodent & nonrodent)
83-2 - Oncogenicity TGAI
Two Species
(rat and mouse)
83-3 - Teratogenicity TGAI
Two Species
A,B,F
A,B,F
A,B,F
AfB,F
Yes
Partially
Yes
Partially
00009727
00009413
No
Yes/48 months
00009413,05007997 No
05009679
05018829,GS032002 Yes/12 months
I/
I/ Composition:TGAI » Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop? B=Terrestrial, Non-Food? OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Rodent and non-rodent studies are required.
4/ A study utilizing a second mammalian species (mouse, hampster or rabbit) must be performed.
30
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DAMINOZIDE
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? When?
83-4 - Reproduction -
Two Generation
Mutagenicity
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Dominant Lethal
Metabolism
85-1 - General Metabolism
Contaminant
TGAI
A,B,F
Partially
00009413
Yes/24 months
TGAI
TGAI
TGAI
PAI or PAIRA A,B,F
A,B,F
A,B,F
A,B,F
Yes
No
Yes
Partially
00009681
00009683
00009414
No
Yes/6 months
No
3/
Yes
- Rodent Oncogenicity Anal, Grade UDMH A,B,F
Yes
GS032001J-05009679 No
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse/ Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ This study was requested under section 3(c)(2)(B) FIFRA on August 25, 1983. This study must be submitted
to the Agency by June 30, 1985.
31
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DAMINOZIDE
I/ Use 2/
Data Requirement Composition Pattern
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
No or Partially) Citation 3(c)(2)(B)? When?4/
S158.145 Wildlife and Aquatic Organisms
Avian and Matronal iam Testing
71-1 - Avian Oral LD50
71-2 - Avian Dietary LD50 -
a. Waterfowl
b. Upland Gamebird
71-3 - Wild Marnnal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated & Actual Field
Testing (Mamma Is/Birds)
Aquatic Organism Testing
72-1 - Freshwater Fish LC50 -
a. Warmwater
b. Coldwater
72-2 - Acute LC50 Freshwater
Invertebrates
TGAI
UDHM
TGAI
UDMH
TGAI
UDMH
TGAI
TGAI
TEP
TGAI
UDMH
TGAI
UDMH
TGAI
UDMH
A,B,F
A,B
A,B
A,B
A,B,F
A,B
A,B,F
A,B
A,B
A,B
A,B,F
A,B
No
No
Yes
No
Yes
No
No
No
Yes
No
No
Yes
Yes
00009703 No
Yes
00009705 No
Yes
3/
3/
!/
Yes
Yes
00009706 No
Yes
Yes
Yes
I/ Composition:TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP » Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Not applicable at this time.
4/ All data must be submitted within 48 months after receipt of the Guidance Document.
32
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DAMINOZIDE
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? When?
Aquatic Organism Testing (Cont'd)
72-3 - Acute LC50 Estuarine &
Marine Organisms
72-4 - Fish Early Life Stage &
Aquatic Invertebrate
Life-cycle
72-5 - Fish Life Cycle
72-6 - Aquatic Organism
Accumulation
TGAI
TGAI
TGAI
V
TGAI, PAI or
Degradation
Product
72-7 - Simulated or Actual
Field Testing (Aquatic
janisms)
TEP
V
I/
3/
Orgc
sltk
_!/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrialf Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcroestic Outdoor; I=Indoor.
3/ Not applicable at this time.
33
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DAMINOZIDE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)7 When??/
S158.125 Residue Chemistry
Metabolism
- Plants
PAIRA
partially 05012551,GS032041, yes
00009474,GS032042,
00009527,00009470,
00009586,GS032003,
GS032022,05021600,
05013980,05016127,
05012420,05012407,
GS032023
3/6/8/
- Livestock
PAIRA & plant
metabolites
partially GS032043,00009528, yes
00009586
Analytical Methods
- Plant Residues
- Animal Residues
TGAI & metabolites
TGAI & metabolites
partially 05015547,00010338, yes
05004402,00009470,
00009586
yes
I/ Composition:TGAI » Technical grade o£ the active ingredient; PAIRA - Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; I=Indoor.
3/ Additional data should be submitted indicating whether UDMH is present at the 1 to 10 ppb level in raw
agricultural commodities resulting from application of daminozide.
4/ Additional data is requested on the formation and presence of daminozide metabolites in tissues and milk.
5/ A reliable analytical method, sensitive from 1 to 10 ppb, must be submitted for the determination of UDMH in
raw agricultural comnodities, tissues, milk and eggs.
j6/ Further testing for N-nitrosodimethylamine is not necessary at this time.
7/ All data must be submitted within 12 months after receipt of the Guidance Document, except as noted.
8/ Animal and plant metabolism data must be submitted to the Agency by June 1, 1984.
34
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DAMINOZIDE
Data Requirement
Storage Stability Data
I/
Composition
PAI
Use 2/
Pattern
_
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
no
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? When?5/
yes
Residue Data
- Crops
o Apples
TEP
yes
00009709,00009716,yes
00009472,00009471,
00009422
3/47
3/47
o Pears (WA & OR, only)
o Sour Cherries
o Sweet Cherries
o Peaches
o Nectarines
o Fresh Prunes (French
Variety, CA only)
o Dried Prunes
yes
yes
yes
yes
yes
yes
yes
GS032021
00009551
00009595
00009594
00009465
00009432
00009432
yes
3/47
yes
I/!/
yes
yes
3/47
yes
yes
3/47
yes
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
37 Residue data on UDMH must be submitted on these commodities.
4/ All residue data were submitted by Uniroyal, Inc. No residue data were submitted by Aceto Chemical Co., Inc.
5/ All data must be submitted within 12 months after receipt of the Guidance Document.
35
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DAMINOZIDE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? When?6/
Residue Data
Crops
o Brussel Sprouts
o Grapes
o Canteloupes (AZ &
CA, only)
o Tomatoes (Field
Grown Transplants)
o Peanuts
TEP
yes
yes
yes
yes
yes
00009429
00009422
00009431
V4/
yes
1/4/5/
yes
3/4/
yes
00009422,00009550 yes
3/4/
00022055,00009582,yes
00022053,00009660,
00009755,00009660,
00009647
3/4/
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Residue data on UDMH must be submitted on these commodities.
4/ All residue data were submitted by Uniroyal, Inc. No residue data were submitted by Aceto Chemical Co., Inc.
5/ The label restriction "Use on Concord Grapes only" should be returned to the label. Otherwise, residue data
for raisins, raisin waste and grape pomace are required.
6/ All data must be submitted within 12 months of the receipt of the Guidance Document.
36
-------
TABLU A
GENERIC DATA REQUIREMENTS FDR DAMINOZIDE
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? When?5/
SI58.125 Residue Chemistry (cont'd)
- Processed Crops TEP
3/
o Apple Pomace
o Raisins, Raisin Waste,
& Grape Pomace
o Tomato Products (concentrated)
o Tomato Pomace
o Peanut Hulls
o Peanut Hay
o Peanut Oil & Meal
- Meat and Milk TEP
'
- Poultry TEP
- Eggs TEP
yes
no
partially
no
yes
yes
yes
yes
yes
yes
00009709
GS032023
00022055
00009513
00009583
00009516,00009462
00009516,00009462
00009516,00009462
yes
v
yes
v
yes
I/
yes
I/
yes
v
yes
v
yes
I/
yes
v
yes
yes
I/ Composition:TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Residue data on UDMH must be submitted on these commodities.
V Registration carried an initial restriction for use on concord grapes only. This restriction no longer remains
on the label. Registrant must submit the referenced data or return to previous restriction.
S/ All data must be submitted within 12 months after receipt of the Guidance Document.
6/ All residue data were submitted by Uniroyal, Inc. No residue data were submitted by Aceto Chemical Co., Inc.
37
-------
II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance 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-I) is
included that identifies that 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 as an attachment to
the cover letter accompanying this guidance 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 V 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 submitted2/. Any
necessary studies must be conducted in accordance with
acceptable protocols, examples of which are contained
in EPA's Pesticide Assessment Guidelines3/, and, for the
most part, in 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.
I/ 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/ O.S. EPA, 1982. Pesticide Registration; Proposed Data
Requirements - Part 158. FEDERAL REGISTER of November 24, 1982
(47 PR 53192).
3/ D.S. EPA, 1983. Pesticide Assessment Guidelines, National
Technical Information Service, Springfield, VA.
38
-------
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 B) 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] 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.
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 III)*/
•.•".
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for n«w products.)
*/ FIFRA Section 3(c)(2){B) authorizes joint development of
data by two or more registrants, and provides * mechanism by
which parties can obtain an arbitrator's decision if they agree
(Footnote continued at bottom of next page)
39
-------
5. Request voluntary cancellation of the registration's)
of your products for which the data are needed.
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree wi-th our 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
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
and .Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to"the
initiation 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 conclude that an extension is appropriate. While
EPA will consider your request, you remain subject to the
deadlines for submitting the required dart a until- £PA~
grants your request.
(Footnote continued from previous page)
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 data 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 unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to 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 us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant 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
Sec'tion 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.
40
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III. 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 IV) 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 of 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)."
41
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IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This chapter 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 suffi-
ciently standardized to avoid user confusion.
As part 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 S162.11(c)], pack-
aging [40 CFR S162.16], and labeling [40 CFR S162.10, Appendix
V-l an V-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 S162.10 (Appendix V-l) requires that certain spe-
cific 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 V-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, ADDRESS AND PHONE NUMBER - The name,
address and phone number 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 $162.10(c)J
Item 3. AVERAGE NET CONTENTS - An average 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 average
net contents must be stated in terms of weight, expressed as
avoirdupois pounds and ounces, and stated in terms of the
42
-------
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~S162.lO(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 registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix V-2. [40 CFR Sl62.10(f)J
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and must contain the name and
nominal percentage by weight of each active ingredient and
the total percentage by weight of all inert ingredients as
indicated in your certification of limits. 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.
43
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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 Appe'ndix V-2. [40 CFR S162.10(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 5162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, 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
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 S162.10(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) ]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary 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 preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix V-2. [40 CFR §162.10
44
-------
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions taken to avoid
accident, injury or damage. See Appendix V-2. [40 CFR §162.10
(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix V-2. [40 CFR
.10(h)(2)(ii)]
item" sc. "PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the criteria in
Appendix V-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 flam-
mability statements.
2. Criteria for declaration of non-flammability. 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 S163.61-8(c)(13)
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the'
method specified in 40 CFR S163.61-8(c)(13)(ii);
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
5l63.61-8(c)(13)(i).
45
-------
3. Declaration of non-flammability. Products which meet
the criteria tor non-flammability specified above may
bear the notation "non-flammable" or "nonflanunable
(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 §162.10(1)(2)(ii)]
Item 10A. 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. Hake 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 is referred to
on the label or which is to accompany the product are termed
collateral labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted
in connection with registration of the product. It should be
made part of the response to this notice and submitted for review,
46
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V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Robert Taylor (PM 25)
Phone No. (703)-557-1800
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
For each product for which continued registration is desired:
1. Within 90" days from receipt of this document, you mast
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).
47
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APPENDIX I
-------
Guide to Use of This Bibliography
. CCSTSH7 OP 3I3LICG2AJ>E2. This bibliography contains
citations of all studies considered relevant, by SPA in
arriving- an tie positions and conclusions stated elsewhere
la the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to SPA. and
its predecessor agencies in support of past regulatory-
decisions. Selections frost other sources including the
published literature., in these instances; where, they have
been- considered, will be included. .
» -UNITS OF-.ETT22. Tie unit of entry in this 'bibliography is
called a "study*. In the case of published materials, this
corresponds closely to an article.. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the
published article from within the typically larger voluaes
in which they were submitted* The resulting- * studies*
generally, have a. distinct, title (or at least: a. single
subject)/ can stand alone for purposes of review, and can be
described with a conventional bibliographic citation. The
Agency has attempted also sa unite basic, docuaents and
sntaries open them,- treating; them as a. single study:
IOEHTI7ICA2XON CF 5STSISS. The- entries in this bibliography
are sorted numerically by '!taster Record. Identifier* ^ or "
M2IIJ, number. This number- is unique to the citation, and
should be used at any time specific reference is required .
It is act related to the six-digit 'Accession- number* which
has been used to- identify volumes of. submitted studies; see-
paragraph 4(d) (4-) below.for a further explanation. In a few
cases, entries added, to. the bibliography late in- the review
say be preceded by & nine-character temporary identifier.
These entries are listed after all MSXS entries. This
temporary identifier: number is also to be used, whenever
specific reference is: needed.
FORM. OT BITST. In addition to the Master Hecord Identifier.
(MSZD), each entry consists, of; a. citation -containing
standard elements followed, in the case o£ materials
submitted ta 2?A, by a description of the earliest known -
submission. Bibliographic conventions used reflect: the
standards of. the American national Standard^ institute
(AHSI), expanded to provide far certain, special, needs.
a. Author. Whenever the Agency could confidently identify
one, the Agency has. chosen to show a personal author.
When no individual vas identified, the Agency has shown
an. identifiable laboratory or tasting facility as
author. As a last resort, the Agency has- shown the
first xnown submitter- as author.
-------
b. Document Date. When the date appears as four digits
with no question aarks, the Agency took it directly
from the document. When a four-digit date is: followed
by a question mar*, the bibliographer deduced the dats
from evidence- in the document. When the date appears
as (13??), the Agency was unable "to determine or
estimate.- the data of the document.
cv Title. In some cases- it has-, bees necessary for Agency
bibliographers to create or enhance a document title..
Any such editorial insertions- are contained between
square- brackets. . •
-d«- Trailing Parentheses* For- studies submitted to the
Agency in. the: past, the trailing parentheses include
(ia addition, to any self-explanatory text) the
following- elements describing* the earliest known
submissions * •
(ifr Submission; Date*. Immediately following the word
'received* appears- the date of. the earliest known
submission*
.C2X Administrative- Number*** The- next element *
.--.-- immediately following the wer& • under % is? the
number r experimental permit numoejrv
petition, numoer-, or other- administrative number
••associated with: the earliest known submission i.
(3) Susmittarv The third element is the susmittsr-,
following- the- phrase 'submitted by'- When
authorship- is- defaulted ta- the subaitter-r this: '
ilcnxmi j»- 'omitted*.
(4-) Volume Identification (Accession: Humoers).
The final, element in the trailing parentheses
identifies- 'the: SPA accession number of the volume
in. which; the original, submission of the study
appear*- the six-digit accession number follows;
ng, foe 'Comoany/ JData.
Library*".. This; accession number- is- in turn
followed: by* an alphabetic suffix- which: shows the
relative 'position. o£ the study within the volume.
For- example, within access ion- number 123 45 o, the*
first study would- be 123456-Ar the second, 123456
B? the 25th 123456-2; and the 27th, 123455-AA^
-------
INDEX OF CITATIONS USED IN THE DATA REQUIREMENT CHARTS
REFERENCES LISTED IN NUMERIC ORDER
MRID NO.
GS032001
GS032002
GS032003
GS032021
GS032022
GS032023
GS032040
GS032041
GS032042
GS032043
00009413
00009414
00009417
00009422
00009423
00009429
00009431
00009432
00009465
00009470
00009471
00009472
00009474
00009511
00009514
00009527
00009528
00009540
00009550
00009551
00009577
00009582
00009586
00009594
00009595
00009681
00009682
00009683
00009703
00009705
00009706
00009707
00009708
00009709
00009725
00009726
00009727
00009737
Author
Toth, 1973
Knickerbocker, 1979
Von Schmelling, 1981
Uniroyal, 1972
Wright, 1981
Uniroyal, 1975
Von Schmelling, 1983
Dahgren, 1963
Sachs, 1967
Tyer, 1967
Oser, 1966
Ryer, 1966
Ames, 1966
U.S. Rubber Co., 1966
Uniroyal, 1975
Uniroyal, 1972
Uniroyal, 1972
Uniroyal, 1972
Uniroyal, 1969
Newell, 1968
Uniroyal, 1967
Edgerton, 1967
Reed, 1965
Uniroyal, 1972
Uniroyal, 19??
Chin, 1970
St. John, 1969
U.S. Rubber Co., 1966
Uniroyal, 1968
Uniroyal, 1968
Dannals, 1972
Uniroyal, 1971
Sisken, 1970
Uniroyal, 1968
Uniroyal, 1968
Brusick, 1977
Griffiths, 1977
Palmer, 1973
Beavers, 1977
Beavers, 1977
Kuc, 1977
Rucharczyk, 1971
Dannals, 1972
Lind, 1975
Sleight, 1973
Erdmann, 1978
Carson, 1964
Carson, 1963
-------
INDEX OF CITATIONS USED IN THE DATA REQUIREMENT CHARTS
REFERENCES LISTED IN NUMERIC ORDER
MRID NO.
00009716
00009725
00009726
00009727
00009737
00009755
00010338
00022043
00022053
00022055
05004402
05007997
05009679
05012407
05012420
05012551
05013980
05015547
05016127
05018829
05021600
Author
State University College of New York, 1972
Sleight, 1973
Erdmann, 1978
Carson, 1964
Carson, 1963
Uniroyal, 1975
Edgarton, 1967
Uniroyal, 1969
Uniroyal, 1969
Uniroyal, 1966
Lynch, 1969
NCI, 1978
Toth, 1977
Shutak, 1968
Martin, 1964
Martin, 1966
Dicks, 1973
Looney, 1972
Takahasi, 1969
Khera, 1979
Newsome, 1980
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Daminozide Registrations
MRID No.
000009417
000009703
000009705
000009681
000009737
000009727
000009527
Citation
Ames, R.B.; Smith, A.E.; Stone, G.M. (1966)
Persistence of Alar-85 in Soil. Method dated
Nov 17, 1966. (Unpublished study received Dec
15, 1966 under 7F0552; submitted by United States
Rubber Co., Naugatuck, Conn.; CDL:090684-K)
Beavers, J.B. (1977) Final Report: Acute Oral LD50
—Mallard Duck: Project No. 117-121.
(Unpublished study received Aug 25, 1977 under
400-79; prepared by Wildlife International,
Ltd., submitted by Uniroyal Chemical, Bethany,
Conn.; CDL:096322-A)
Beavers, J.B. (1977) Final Report: Eight-Day
Dietary LC50—Bobwhite Quail: Project No.
117-126. (Unpublished study received Aug 25,
1977 under 400-79; prepared by Wildlife
International, Ltd., submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:096322-C)
Brusick, D.J.; Weir, R.J. (1977) Mutagenicity
Evaluation of B995: Final Report: LB1 Project
No. 2683. (Unpublished study received Mar 10,
1978 under 400-117; prepared by Litton Bionetics,
Inc., submitted by Uniroyal Chemical, Bethany,
Conn.; CDL:233200-D)
Carson, S. (1963) Report: Toxicological Examinations
of Compound B-995. (Unpublished study received
Apr 12, 1963 under unknown admin, no.; prepared
by Food and Drug Research Laboratories, Inc.,
submitted by Uniroyal Chemical, Bethany, Conn.;
CDL: 127047-B)
Carson, S. (1964) Report: Subacute (90-Day) Feeding
Studies with B-995 in Rats. (Unpublished
study including supplement, received May 19,
1966 under unknown admin, no.; prepared by Food
and Drug Research Laboratories, Inc. for United
States Rubber Co., submitted by Uniroyal
Chemical,.Bethany, Conn.; CDL: 104894-B)
Bethany, Conn.; CDL: 104894-B)
Chin, W.T.; Stone, G.M. (1970) Fate of Alar in Peanut
Plants and Peanuts. (Unpublished study received
Feb 11, 1971 under OF0990; submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:091704-M)
-------
GS0032041 Dahlgren and Simmerman (1965) Science 148:485.
000009708 Dannals, L.E.; Puhl, R.J.; Kucharczyk, N. (1972)
Environmental Fate Studies on Alar (R)*:
Second Status Report on PR 70-15: Work on
Succinic acid 2,2-dimethylhydrazide (Alar-85,
Kylar-85, Kylar). (Unpublished study received
Apr 20, 1972 under 400-79; submitted by Uniroyal
Chemical, Bethany, Conn.? CDL:120367-A)
000009577 Dannals, L.E.; Lane, J.R.; Stone, G.M.; et al.
(1974) The Persistence of Alar (R)* in Soil
under Field Conditions. (Unpublished study
received Oct 13, 1976 under 6F1752; submitted
by Uniroyal Chemical, Bethany, Conn.;
CDL:095566-C)
005013980 Dicks, J.W. (1972) Uptake and distribution of the
growth retardant, aminozide, in relation to
control of latera shoot elongation in Chrysanthemum
morifoliura. Annals of Applied Biology 72(3):313-326
000009472 Edgerton, L.J. (1967) Alar Residue Analyses of Apple
Fruit Samples from Orchard Tests in New York—1967.
(Unpublished study including letter dated Dec
19, 1967 from L.J. Edgerton to Paul Bohne,
received Mar 5, 1968 under 8F0704; prepared by
Cornell Univ., Dept. of Pomology, Pesticide
Residue Laboratory, submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:091224-C)
000010338 Edgerton, L.J.; Rockey, M.L.; Arnold, H.; et al.
(1967) Colorimetric determination of Alar
residues in apples. Journal of Agricultural
and Food Chemistry 15(5):812-813. (Also In
unpublished submission received Feb 7, 1968
under 8F0704; submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:093010-B)
000009726 Erdmann, M.R.; Jackson, C.E.; Meek, R.D.; et al.
(1978) Alar (R)»14C Rotational Crop Study:
Project No. 7701. (Unpublished study received
Sep 29, 1978 under 400-49; submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:097590-A)
000009682 Griffiths, J.; Babish, J.G. (1977) Report: Primary
Skin Irritation Study with Rabbits. (Unpublished
study received Mar 10, 1978 under 400-117;
prepared by Food and Drug Research Laboratories,
Inc., submitted by Uniroyal Chemical, Bethany,
Conn.; CDL: 233200-E)
-------
005018829
GS0032002
000009706
000009707
000009709
005015547
005004402
005Q-.2551
Khera, K.S.; Whalen, C.; Trivett, G.; Angers, G.
(1979; Teratologic assessment of maleic hydrazide
and daminozide, and formulations of ethoxyquin,
thiabendazole and naled in rats. Journal of
Environmental Science and Health, Part B
14(6):563-577.
Knickerbocker, M. (1979) Teratogenic Evaluation of
Alar Technical in Sprague-Dawley Rats.(00053764)
(Unpublished study received under pesticide
petition 6F1752; prepared by Food and Drug
Research Laboratories, Inc.; submitted by
Uniroyal, Inc. Bethany, CT; CDL: 237850)
Kuc, W.J. (1977) Acute Toxicity of Alar Technical,
Lot BL 8190 to the Rainbow Trout, Salmo
gairdneri Richardson; UCES Project No. 11506-29-04.
(Unpublished study received Aug 25, 1977 under
400-79; prepared by Union Carbide Corp.,
submitted by Uniroyal Chemical, Bethany,
Conn.; CDL:096322-D)
Kucharczyk, N.; Smith, A.; Stone, G. (1971)
Environmental Fate Studies on Alar (R)*:
Status Report on PR 70-15: Work on Succinic
acid 2,2-dimethylhydrazide (Alar-85, Kylar-85,
Kylar). (Unpublished study received Sep 27,
1971 under 400-79; submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:120366-A)
Lind, L.R.; LaBelle, R.L. (1975) Summary of Alar
(R)* Residues in Processed Apples. (Unpublished
study received Dec 3, 1975 under 400-79; prepared
in cooperation with State Univ. College of New
York—Oswego, Lake Ontario Environmental
Laboratory and Cornell Univ., New York State
Agricultural Experiment Station, submitted
by Uniroyal Chemical, Bethany, Conn.; CDL:222341-A)
Looney, N.E.; Williams, K.; Wardle, G.A. (1972)
Factors influencing the level of succinic acid-
2,2-dimethylhydrazide residues in apple fruits.
Journal of the American Society for Horticultural
Science 97(3):323-325.
Lynch, V.P. (1969) Method for determining "Alar"
(B-995) residues in apples. Journal of the
Science of Food and Agriculture 20(1):13-14.
Martin, G.C.; Williams, M.W. (1966) Breakdown
products of C14 labeled N-dimethyl amino succinamic
acid (Alar) in the apple tree. Proceedings of
the American Society for Horticultural Science
89:1-9.
-------
005012420 Martin, G.C.; Williams, M.W.; Batjer, L.P. (1964)
Movement and fate of labeled N-dimethylamino
succinamic acid (B-Nine), a size controlling
compound, in apple seedlings. Proceedings of
the American Society for Horticultural Science
84:7-13.
005007997 National Cancer Institute (1978) Bioassay of
Daminozide for Possible Carcinogenicity.
Washington, D.C.: United States Department of
Health, Education and Welfare, Public Health
Service. (NCI Carcinogenesis technical report
series no. 83; DHEW publication no. (NIH)
78-1333)
000009470 Newell, J.E.; Capobianco, J.D.; Paul, S. (1968)
The Determination of [a nitroso-amine] at the
Parts per Billion Level. Method dated Jan 15,
1968. (Unpublished study including extract from
letter dated Jul 21, 1967 from J.B. Lamb to H.D.
Tate, received Feb 7, 1968 under 8F0704; submitted
by Uniroyal Chemical, Bethany, Conn.; CDL:093010-C)
005021600 Newsome, W.H. (1980) Determination of daminozide
residues on foods and its degradation to 1,1-
dimethylhydrazine by cooking. Journal of
Agricultural and Food Chemistry 28(2):319-321.
000009413 Oser, B.L. (1966) Report: Chronic (2-Year)
Feeding Studies with B995 in Rats and Dogs.
(Unpublished study including letters dated Nov
1, 1966 from S.S. Sternberg to Bernard L. Oser
and from M.N. Daniels to Bernard L. Oser,
received Dec 15, 1966 under 7F0552; prepared
by Food and Drug Research Laboratories, Inc.,
submitted by United States Rubber Co., Naugatuck,
Conn.; CDL:090684-E)
000009683 Palmer, A.K.; Love11, M.R. (1973) Dominant Lethal
Assay of Alar in the Male Mouse. (Unpublished
study received Mar 10, 1978 under 400-117;
prepared by Huntingdon Research Centre, submitted
by Uniroyal Chemical, Bethany, Conn.; CDL:233200-F)
000009474 Reed, D.J.; Moore, T.C.; Anderson, J.D. (1965) A
possible mode of action of the plant growth
retardant B-995. Science 148(3070): 1469-1471.
(Also In unpublished submission received Mar 5,
1968 under 8F0704; submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:091224-E)
-------
000009414
GS0032042
000009586
005012407
000009725
000009528
000009716
Ryer, F.H. (1966) Radiotracer Metabolism Study:
Alar-14C: Final Report. (Unpublished study
received Dec 15, 1966 under 7F0552; prepared
by Hazleton Laboratories, Inc., submitted by
United States Rubber Co., Naugatuck, Conn.;
CDL:090684-F)
Sachs and Ryogo (1967) Unpublished study in pp #
8F0704, performed by the University of California,
Davis, CA, dated Dec 6, 1967).
Sisken, H.R. (1970) The Determination of Nitrosodi-
methylamine at the Parts per Billion Level in
Milk. Method dated May 21, 1970. (Unpublished
study received Jun 1, 1970 under OF0990; submitted
by Uniroyal Chemical, Bethany, Conn.; CDL:093299-F)
Shutak, V.G.; Olney, C.E.; Kerr, T.W. (1968) Succinic
acid 2,2-dimethylhydrazide residues after
application to apple trees. Proceedings of the
American Society for Horticultural Science
92:63-66.
Sleight, B.H., III (1973) Research Report Submitted
to Uniroyal Chemical, Naugatuck, Connecticut:
Exposure of Fish to 14CLabeled Alar: Accumulation,
Distribution, and Elimination of 14C-Residues.
(Unpublished study including letter dated Jun 4,
1973 from A.W. Mitlehner to Charles L. Smith,
received Jun 7, 1973 under 400-79; prepared by
Bionomics, Inc., submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:124939-A)
St. John, L.E., Jr.; Arnold, H.; Lisk, D.J. (1969)
Metabolic studies with Alar growth regulator in
the dairy cow. Journal of Agricultural and
Food Chemistry 17(1):116-117. (Also In unpub-
lished submission received Feb 11, 1971 under
OF0990; submitted by Uniroyal Chemical, Bethany,
Conn.; CDL:091704-R)
State University College of New York—Oswego, Lake
Ontario Environmental Laboratory (1972) Residues
in PPM. (Unpublished study received Jun 12,
1972 under 400-79; submitted by Uniroyal Chemi-
cal, Bethany, Conn.; CDL:003255-C)
-------
005016127
GS0032001
005009679
GS0032043
000009514
000022043
000009511
000009423
000009471
Takahashi, E.; Yamada, Y.; Konishi, S.; Matsuda, T.;
Yamamoto, O. (1969) Seichoyokuseizai B 995 no
dojo oyobi shokubutsutai chu niokeru kyodo to
seirikassei. The behavior and physiological
activity of the growth retardant B*995 in soil
and plants Nippon Dojo-Hiryogaku Zasshi.
Journal of the Science of Soil and Animal
Fertilizers, Japan 40(2):84-88.
Toth, B. (1977) 1,1-Dimethylhydrazine (unsymmetrical)
carcinogenesis in mice. Light microscopic and
ultrastructural studies on neoplastic blood
vessels. Journal of the National Cancer
Institute 50:181-187.
Toth, B.; Wallcave, L.; Patil, K.; Schmeltz, I.;
Hoffmann, D. (1977) Induction of tumors in
mice with the herbicide, succinic acid 2,2-
dimethylhydrazide. Cancer Research 37(10):
3497-3500.
Tyer, F.H.; Sullivan, J.B. (1967) (Private
communication from Hazelton Laboratories to
Uniroyal Laboratories).
Uniroyal Chemical (19??) Alar (R)® Manufacturing
Process. (Unpublished study received Mar 4,
1976 under 6F1752; CDL:096519-B)
Uniroyal, Incorporated (1969) Control Test AC-1031:
Neutralization Equivalent of Alar Tech. Rev.
Method dated Sep 8, 1969. (Unpublished study
received May 8, 1974 under 4F1504; CDL:093986-D)
Uniroyal, Incorporated (1972) Alar (R)®, Succinic
acid 2,2-dimethylhydrazide: Alternate Names-
-B995, B-9, B-Nine (R)®. (Unpublished study
received May 8, 1974 under 4F1504; CDL: 093986-A)
Uniroyal, Incorporated (1975) Alar-85: Analysis
- for Alar in Alar-85 and Kylar-85 (via Bromide/
Bromate Titration). Method AC-1060-C dated
Jun 24, 1975. (Unpublished study including
letter dated Jul 10, 1975 from A.W. Mitlehner
to Robert J. Taylor, received Jul 16, 1975
under 2F1271; CDL:095331-A)
Uniroyal, Incorporated (1967) Alar Analysis on Apples,
(Unpublished study received Mar 5, 1968 under
8F0704? CDL:091224-B)
-------
000009594
000009551
000009550
000009595
000009465
000009582
000009429
000009431
000009432
GS0032021
Uniroyal, Incorporated (1968) Alar Residue in Peaches.
(Unpublished study received Jun 4, 1969 under
9F0813; prepared in cooperation with Morse
Laboratories; CDL:091403-B)
Uniroyal, Incorporated (1968) Alar Residues in Sour
Cherries. (Unpublished study received May 29,
1970 under OF0923; CDL: 091577-B)
Uniroyal, Incorporated (1968) Alar Residues in
Tomatoes. (Unpublished study received May 29,
1970 under OF0923; CDL:091577-A)
Uniroyal, Incorporated (1968) Alar Residues on Sweet
Cherries. (Unpublished study received Jun 4,
1969 under 9F0813; prepared in cooperation with
Morse Laboratories; CDL:091403-C)
Uniroyal, Incorporated (1969) Alar Residue in
Nectarines. (Unpublished study received Aug
10, 1971 under 1F1056; prepared in cooperation
with Morse Laboratories; CDL:091891-C)
Uniroyal, Incorporated (1971) Summary of 1970—Alar
Residues in Peanuts. (Unpublished study received
on Jun 1, 1970 under OH2553; prepared in cooperation
with Syracuse Univ. Research Corp.; CDL:221694-A)
Uniroyal, Incorporated (1972) The Effects of EPA
Tolerance Pesticides upon the Recovery of Alar
(R)* Residues from Brussel Sprouts. (Unpublished
study received Oct 3, 1972 under 2F1271; prepared
in cooperation with Morse Laboratories; CDL:091801-A)
Uniroyal, Incorporated (1972) The Effects of EPA
Tolerance Pesticides upon the Recovery of Alar
(R)* Residues from Melons. (Unpublished
study received Oct 3, 1972 under 2F1271;
prepared in cooperation with Morse Laboratories
and State Univ. College of New York—Oswego,
Lake Ontario Environmental Laboratory; CDL:
091801-C)
Uniroyal, Incorporated (1972) The Effects of EPA
Tolerance Pesticides upon the Recovery of Alar
(R)* Residues from Prunes. (Unpublished study
received Oct 3, 1972 under 2F1271; prepared in
cooperation with Morse Laboratories CDL:091801-D)
Uniroyal, Incorporated (1972) Residues in ppm -
pears (Unpublished study received under 3F1408).
-------
GS0032023 Uniroyal, Incorporated (1974) Residues in tomato
paste (Unpublished study received under pp #
3F1408/FAP f 6H5101).
000009755 Uniroyal Chemical (1975) Summary of Residue Data on
Split Applications of Kylar-85 on Peanuts.
(Unpublished study received May 12, 1976 under
400-103; prepared in cooperation with State Univ.
College of New York—Oswego, Lake Ontario
Environmental Laboratory and Morse Laboratories;
CDL:224486-A)
000009422 United States Rubber Company (1966) Index to Residue
Analyses. (Unpublished study received Dec 15,
1966 under 7F0552; CDL: 090684-P)
000009540 United States Rubber Company (1966) Name, Chemical
Identity, and Composition: Alar (Unpublished
study received Dec 20, 1966 under 7F0552;
CDL:094768-J)
GS0032003 Von Schmelling, B. (1981) Letter sent to J.
Schwemley dated Mar 23, 1981. [Concerns Uniroyal
Chemical's evaluation of the 1980 study by
Newsome (MRID 005021600)]
GS0032040 Von Schmelling, B. (1983) Uniroyal submission of
May 27, 1983. (Accession Number 250943, MRID
No. 00130644)
GS0032022 Wright, D. Jr. (1981) Letter to K.F. Kissler
dated July 17, 1981. "Hydrolysis Study of Alar"
-------
APPENDIX II
-------
GMU ^^art-vai No
F1FHA SECTION 3(C5(23(B) SUMMARY SHEET
6FA REGISTRATION NO.
?flOCUCT NAME
NAME
OATS GLilOANCS DOCUMENT ISSUES
Oocanwnt, 1 am raqnndinq in 3» fuUowinq i
. I wH stOatrt dm. in « tgmy rtanttr -a antfy a» foJUminy tmuinman^ If
4Uti/lMt iflj ^u ni^sDVtifln 5ui
M9
r F1FHA acnon 3
-------
APPENDIX III
-------
OM8
•31-331
(Ta aatifv. orcHyA^ fourfnmsi
CSHT1F1CA710N OF ATTEMPT TO SNTSH
INTO AN AaSESMENTWITH OTHE3 REGISTRANTS
FOR DEVELOPMENT OP DATA
1. I am duly autnorizad as reomant «• following firm
-------
APPENDIX IV
-------
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
Registration
Guideline Mo.
§153.20
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
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
Name of Test
-
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Cdor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID*
Submit-
ting
Data
(At-
tached)
»
(For EPA Use Only)
Accession Numbers
Assigned
-
-------
63-20
63-21
§156.135
TOXICOLOGY
81-1
81-2
- 81-3
81-4
81-5 '
81-6
Corrosion
character! sties
Dielectric break-
down voltaqe
Acute oral LD-50f
rat
Acute dermal
ID-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
• •
-------
APPENDIX V-l
-------
Chapter I—Environmental Protection Agency
cant obtained the data from another
firm (identify); applicant copied data
from a publication; applicant obtained
a copy of the data from EPA).
(d) The applicant shall submit with
his application a statement that EPA.
in Its evaluation of the properties, effi-
cacy, and safety of the formulated
end-use product, may not consider any
data as supporting the application.
except the following data:
(1) The data the applicant has sub-
mitted to EPA under paragraph (b) of
this section;
(2) Other data pertaining to the
safety of the product's active ingredi-
ents, rather than to the safety of the
end-use product; and
(3) Existing tolerances, food additive
regulations, exemptions, and other
clearances issued under the Federal
Pood, Drug, and Cosmetic Act.
(e) If the applicant knows that any
item of data he submitted under this
lection was generated by (or at the ex-
pense of) another person who original-
ly submitted the data to EPA (or its
predecessor. USD A) on or after Janu-
ary 1. 1970- to support an application
for registration, experimental use
permit, or amendment adding a new
use to an existing registration, or for
^registration (unless the applicant
and the original data submitter have
reached written agreement on the
amount and the terms of payment of
any compensation that may be pay-
able under PIFRA section
3(c)(l)(D)(ii) with regard to approval
of the application), the applicant shall
submit to EPA a statement that he
has furnished to each such identified
original data submitter:
(1) A notification of the applicant's
intent to apply for registration, includ-
ing the proposed product name;
(2) An offer to pay the person com-
pensation, with regard to the approval
of the application, to the extent re-
quired by FIFRA sections 3(c)U)(D)
and 3(cM2XD);
(3) An identification of the ilem(s)
of data to which the offer applies:
(4) An offer to commence negotia-
tions to ascertain the amount and
terms of compensation to be paid; and
(5) The applicant's name, address.
and telephone number.
§ 162.10
(f) If the applicant's product con-
tains any active ingredient other than
those that are present solely because
of the incorporation into the product,
during formulation, of one or more
other registered pesticide products
purchased from another producer.
then the applicant shall also comply
with § 162.9-5 as to such active ingre-
dient, and the application shall con-
tain an acknowledgment that for pur-
poses of FIFRA section 3(cKl)(D) the
application relies on (and any result
ing registration should be regarded as
if it were based on the Administrator's
consideration of) the following dala:
(1) All data submitted or specifically
cited by the applicant in support of
the registration; and
(2) Each other item of data in the
Agency's files which:
(i) Concerns the properties or effects
of any such active ingredient: and
(ii) Is one of the types of data that
EPA would require to be submitted for
scientific review by EPA if the appli-
cant sought the initial registration
under FIFRA Section 3(c)(5) of a
product with composition and intend-
ed uses identical to those proposed for
the applicant's product, under the
data requirements in effect on the
date EPA approves the applicant's
present application.
(Sees. 3. 6. and 25 of FIFRA, as amended. 7
U.S.C. 136 et teq.)
(44 FR 27953. May 11, 1979]
6 162.10 1-abelinic requirements.
(a) General—(1) Contents of the
label. Every pesticide products shall
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 clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this
section;
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(iii) The net contents as prescribed
in paragraph (d) of this section:
27
-------
§ 162.10
Title 40—Protection of Environment
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this
section:
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section:
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix> The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling bythe Act or
the regulations in 'this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
(ii) Tank cars and other bulk con-
tainers—IA) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car. tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the lime
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers.
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use. shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(qXl)(A) of the
Act. a pesticide or a device declared
subject to the Act pursuant to
i 162.15. is misbranded if its labeling is
false or misleading in any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbranding include:
(i) A false or misleading statement
concerning the composition of the
product;
(11) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device:
(lit) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
(iv) A false or misleading comparison
with other pesticides or devices:
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
28
-------
Chapter I—Environmental Protection Agency
§162.10
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling:
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe." "nonpoison-
ous." "noninjurious." "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph
-------
§ 162.10
Title 40—Protection of Environment
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—<1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement.
(i) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in-
gredient shall .be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common namr
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(cX6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(1) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement in a prominent position on
the label: "Not for sale or use after
[date]."
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Admlnis
trator may require the name of any
30
-------
Chapter I—Environmental Protection Agency
§ 162.10
inert ingredienUs) to be listed in the
ingredient statement if he determines
that such ingredienus) may pose a
hazard to man or the environment.
(h> Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
TcuocKy categories
Hazard Motors
Or* tO»
mninsnn LC»
Dermal tO.
Cye effects
•km effect*
1
Up to and inaukno. SO
mo/ kg
Up to end ndukng .2
mg/ liter
Up to end mdudng 200
rug/kg
Corrosive corned
withm 7 days.
Corrosive
II
From SO thru 500 mg/kg .
From 2 thru 2 ing/Mar
From 200 thru 2000
Comeal opacity
days, vntation
Denoting lor 7 days
Severe rotation at 7?
rvxn
HI
From 500 thru 5000 mg/
"•8
From 2 tV- 20 mg/U&-..
From 2.000 thru 20.000.
No comeal opacity.
•Ohm 7 days
Moderate irritation at 72
hours
IV
Greater than 5000 mg/
t.g
Greater than 20 mg/Me'
dealer than 20.000
No irritation
Mild or skght mlation al
72 hours
(i) Human hazard signal word—(A)
Toxicity Category I. AH pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if tne product was assigned to
Toxicity Category I on the basis of its
oral. Inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
Toxicity Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
icity. The Agency may. however.
permit reasonable variations in the
31
-------
§ 162.10
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXD(iiiXA) of
this section. The applicant may. how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label in
accord with paragraph (hX2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative, to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
chows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Title 40—Protection of Environment
Sue ot label front panel in square
nches
fonts
Reoo-eO
word. an
capitals
Sand under
Above 5 to 10
Above 10 to IS
Above IS to 30. «...
Over 30
6 :
10 ,
14
IS
"Keep out
ol reacfi oi
Children
e
1C
1?
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi
eating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
TOHCMy
category
Precautionary statements by taoaty category
Oral, nhelatien. or dermal tojuoty
(V
Fatal (pooonoua) if smaaomd Inhaled or absorbed
I vrough skn] Do not breathe vapor (dual or spray
i mat] Do not get in eyes, on skn. or on dotting
[From panel statement of praam treatment re-
I quired]
> May be fatal if lanlonisd (nhajad or absorbed
through Vie skn). Do not breathe vapors (dust or
spray mat). Do not get in eve*, on skn. or on
ctolfimQ I Appropmtti) f*nt MO •taMwnonta) fVQUefoo-J-
HarmU if i»allo»sa (nhektd e> abaorbed through tie
skn]. Avert breathing vapors (duet or spray mat]
Avoid contact vjtfh skn (eyes or doting). (Appro-
priate fcrsf aid statement required ).
(No precaubonery statements required].- -
Skin and eye local effects
Corrosive, cause* eye and dun damage lor skin
rntahon]. Do not gel n eyas, on slun. or on
dotting. Wear goggkn or lace show and rubber
gloves «han nanrjang. Harmful or lalat r) swafcwed
[Appropriale M aid statement reqund)
Camel eye land skin] Makon Do not get « eyes.
on skn. or on dotting HarmM * *»eSo»eO (Ap-
propriate flirat aid statement tequred)
Avoid eomect «eti ekn. eyes or dotting n ease of
contecl immaOe«il| «ueh eyes or skn aim plenty el
d eTfetBl>on
mdl
(Not
(ii) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
hazard statements and the circum-
32
-------
Chapter I—Environmental Protection Agency
§ 162.10
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LDM of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less.
the statement "This Pesticide is Toxic
to Pish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LDM of 100
me/kg or less, or a subacute dietary
LC*, of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
t
lam* eitenson « more than 18 m long at a distance i sparks, and open Name Do not puncture 01 mcinetaie container
Of 6 in trom me flam?
Ml omer pressuruad conlaxecs
At or betow 20' f
Above K f and not ove- 60* F ...
Above SO f and not over ISO F
i
(B)
Eiposure lo temperatures above 130' F may cause bursting
Contents under pressure Do not use or More near heal or open
name Do not punctuie or incinerate container Exposure lo
temperatures above 130" F may cause bursting
AINERS
Eitremery flammable Keep away from f«». sparks, and Healed
surfaces
Flammable Keep away trom heat and open flame i
Do not use
-------
§ 162.10
Title 40—Protection of Environment
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(/) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(.1) There is information readily
available to the formulators on the
composition, toxicity. methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes:
<2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
13) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered: and
14) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in 162.10(j) immedi-
ately under the heading "Directions
for Use."
(ii) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and typefs) of application ap-
paratus or equipment required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing (See Table in 1162.10(h)(lMiv).)
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
34
-------
Chapter I—Environmental Protection Agency
§162.11
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22. 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j>U> and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s). both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of § 162.100M2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" 'mmediately below the
heading "Dim '.ions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(i) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
table in § 162.10
-------
APPENDIX V-2
-------
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER TO 'HIE SAMPLE LABELS FOLLOWING)
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
EPA Reg. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
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 by. . . ," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.
-------
ITEM
7C
7D
7E
8
flA
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (In red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
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
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.
-------
ITEM
8C
9A
9C
10A
IOC
10D
U.S.
V
LABEL EIJEMENT
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
chol inesterase
inhibitors
All products
V
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
-------
PRODUCT
NAME
Hfeii i. HJCI eJ USE
PS3T3CCS
PRODUCT
NAME
®
-------
APPENDIX V-3
-------
Criteria
PHYSICAL-CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
APPENDIX V-4
-------
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for -use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(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 the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
-------
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
. pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
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 the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal.*
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
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 State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The 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 "P" 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:
-------
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed^ of on site or at an approved waste disposal
facility."
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
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
trash. 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 fcy
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke. ^^
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
-------
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^-, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar 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.
-------
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
-------
Pesticides that 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 p'entoxide"
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-d initrophenol
Dieldrin
0,0-Diethyl S-[2-ethyIthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl .0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 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
Methomy1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform _
o-Chlorophenol
4-Chloro-o-toluidine 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 phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-DiChlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Preon 12 )
3,5-Dichloro-N-(l,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
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)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentad iene
Hexachloroethane
Hydrofluoric acid
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"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Isobutyl alcohol •
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-p_entanone (methyl isobutyl ketone)
Naphthalene ~
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
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-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11*)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
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"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetopnenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluorpmethane (Freon 12*)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluororaethane (Freon 11*)
Vinyl chloride
Xylene
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