EPA
United StatM
Emfranimntal Protection
Agency
Off l0» Of
Pwtlckta and Toxie Subnanc«
Washington OC 20460
September 1986
Guidance for the
Reregistration of
Pesticide Products
Containing
1, 3-Dichloropropene
as the Active Ingredient
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GUIDANCE FOR THE
RSREGISTRATION OF PESTICIDE PRODUCTS
(REGISTRATION STANDARD)
CONTAINING
. 1,3-DICHLOROPROPENE (TELONE II®)
AS THE ACTIVE INGREDIENT
CHEMICAL CODE: 029001
CAS: 5^2-75-6
CASE NUMBER: GS-0328
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
SEPTEMBER 18, 1986
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TABLE OF CONTENTS
I. Introduction
II. Chemical Covered by this Standard . .
A. Description of Chemical 4
B. Use Profile H
III. Agency Assessment
A. .Summary 5
B. Preliminary Risk Assessment 7
C. Other Science Findings 19
D. Tolerance Reassessment 21
IV. Regulatory Position and Rationale
A. Regulatory Positions 22
B. Criteria for Registration 25
C. Acceptable Ranges and Limits 25
D. Required Labeling 26
V. Products Subject to this Standard 29
VI. Requirement for Submission of Generic Data 31
A. What are generic data? 31
B. Who must submit generic data? 31
C. What generic data must be submitted? 32
D. How to comply with DCI requirements - 32
E. Procedures for requesting a change in protocol 34
F. Procedures for requesting extensions of time 34
G. Existing stocks provisions upon suspension or 35
cancellation
VII. Requirement for Submission of Product-Specific Data . . 36
VIII.. Requirement for Submission of Revised Labeling ..... 37
IX. Instructions for Submission. . . 38
A. Manufacturing use products (sole active) 38
B. Manufacturing use products (multiple active) 39
C. End use products 39
D. Intrastate products 40
E. Addresses 40
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CPR 162.10 Labeling Requirements
Physical/chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. "FORMS APPENDICES
EPA Form 8580-1 PIPRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Formulator's Exemption Statement
ii
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GLOSSARY FOR ACRONYMS
1. The AGENCY: U.S. Environmental Protection Agency/EPA
2. A.I.: Active Ingredient
3. DCI: Data Call-in Notice
4. EPs: End-use products
.,5. EUP: Experimental Use Permit
6. FIFRA: Federal Insecticide, Fungicide, Rodenticide Act (As Amended)
7. MPs: Manufacturing-use products
8. NTP: National Toxicology Program/Department of Human Health
Services
9. NPDES Permit: National Pollutant Discharge Elimination System
Permit
10. OES: Office of Endangered Species, U.S. Dept. of Interior
11. RAG;'s:, Raw agricultural commodities
12. 40 CFR: Title 40 of the U.S. Code of Federal Regulations
iii
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I. INTRODUCTION
The Registration Standards Program
EPA has established the Registration Standards program in
order to provide an orderly mechanism by which pesticide products
containing the same active ingredient can be reviewed,and standards
set for compliance with PIPRA. The standards are applicable to
reregistration anf. future applications for registration of products
containing the same active ingredient. Each registrant of a product
containing an active Ingredient subject to this Standard who wishes
to continue to sell or distribute that product must bring his
product and labeling into compliance with PIPRA, as instructed by
this Standard. Pesticides have been grouped into use clusters and
will be reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed crops;
and (2) pesticides produced in large volumes.
The Registration Standards program involves a thorough review
of the scientific data base underlying a pesticide's registration.
The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the pesticide;
to determine the need for additional data on health and environmental
effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criteria of PIPRA. In its review
EPA identifies:
1. Studies that are acceptable to support the data require-
ments for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued regis-
tration. The additional studies may not have been required when
the product was initially registered or may be needed to replace
studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product is
not misbranded and that the labeling is adequate to protect man
and the environment.
The detailed scientific review, which is not contained in
this document, but is available upon requestl, focuses on the
pesticide active ingredient. The scientific review primarily
discusses the Agency's evaluation of and conclusions from available
data in its files pertaining to the pesticide active ingredient.
1
The science reviews are available upon request from the Information
Services Section, Room 236, CM#2, 1921 Jefferson Davis Highway,
Arlington, Va 22202, (Phone (703) 557-4453).
90 days after issuance, these reviews may be purchased from the
National Technical Information Service, 5285 Port Royal Road,
Springfield Virginia 22161.
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However, during the review of these data the Agency Is also looking
for potential hazards that may be associated with the end use
products that contain the active ingredient. The Agency will
apply the provisions of this Registration Standard to end use
products if necessary to protect man and the environment.
EPA's reassessment results in the development of a
rerulatory position, contained In this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with PIPRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or
contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in the
issuance of a Notice of Intent to Cancel or a Notice of Intent to
Suspend (in the case of failure to submit data). In addition, in
cases in which hazards to man or the environment are identified, the
Agency may initiate a special review of the pesticide in accordance
with 40 CPR Part 154 to examine in depth the risks and benefits of
use of the pesticide. If the Agency determines that the risks of
the pesticide's use outweigh the benefits of use, the Agency may
propose additional regulatory actions, such as cancellation of
uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions of
PIPRA sec. 3(c)(2)(B) to require that registrants submit data to
answer our questions regarding the chemical, toxicological, and
environmental characteristics and fate of a pesticide. This Regis-
tration Standard lists the data EPA believes are necessary to
resolve our concerns about this pesticide. These data are listed
in the Tables A, and B in Appendix I. Failure to comply with the
DCI requirements enumerated in this Registration Standard may
result in Issuance by EPA of a Notice of Intent to Suspend the
affected product registrations.
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Registrants are reminded that PIFRA sec. 6(a)(2) requires them
to submit factual information concerning possible unreasonable
adverse effects of a pesticide at any time that they become aware of
such information. You should notify the Agency of any information,
including interim or preliminary results of studies, if those
results suggest possible adverse effects on man or the environment.
This requirement continues as long as your products are registered
by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD •
A. Description of chemical
The following chemical is covered by this Registration
Standard:
Common name: Dichloropropene
Chemical name: 1,3-Dichloropropene
CAS Number: 5^2-75-6
0?P (Shau^hnessy) Number: 029001
Empirical Formula: C^HijC^
Trade names: Telone II®, Dow Telone®
Year of Initial
Registration: 1966
U.S. Producer: Dow Chemical Company
Description of physical characteristics of chemical:
1,3-dichloropropene is a pale yellow liquid at room temperature.
The empirical formula is C3H4C12, and its molecular weight is
110.98. It is miscible in hydrocarbon solvents.
B. Use Profile
Type of Pesticide : Broad spectrum soil fumigant
Pests Controlled : Nematodes, plant diseases, insects
and weeds.
Registered Uses : Vegetables, field crops, citrus fruit
trees, deciduous fruit & nut trees,
bush and vine crops, ornamentals.
Predominant Uses : Potatoes, tomatoes, carrots, tobacco,
pineapples, and crucifers.
Mode of Activity : Soil fumigation to control plant pests,
Formulation Types
Registered : 9^% liquid formulation
Method of Application : Mainly applied as preplant fumigant by
chisel injection.
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed all data submitted to support the registra-
tion of 1,3-dichloropropene (Telone II®). Based on the review of
these data, the Agency has reached the following conclusions. See
Section B of this Part for a discussion of this review.
1. Oncogeniclty
The Agency has categorized 1,3-dichloropropene as a probable
human carcinogen. The data which justifies the Agency's
position are:
a.) Chronic toxicity data indicate that 1,3-dichloropropene
is oncogenic in both sexes of two species of test
animals (rat and mouse);
b.) A 77 week subcutaneous injection study indicated
Increased incidence of fibrosarcomas at the site of
Injection;
... .c.). Several tests using procaryotic cells have indicated
• ':•. 1,3-dichloropropene to be a direct-acting mutagenj and
d.) 1,3-dichloropropene is structurally similar to other
known oncogens (I.e. vinyl chloride), or known human
oncogens.
Since 1,3-dichloropropene has met the risk criterion for
oncogenicity in 40 CPR Section 15M.7(a)(2), the Agency has
placed this chemical in Special Review.
2. Dietary Exposure And Risk
1,3-dichloropropene has been registered for the uses (vegetable
& field crops, citrus, fruit and nut trees) previously con-
sidered to be nonfood uses, and, thus, there are currently
no tolerances established for 1,3-dichloropropene. In the
past, the uses were considered nonfood uses when the pesticide
was applied to the soil prior to planting and residues in the
resulting crops were not expected.
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Since the available data were inadequate to determine the pre-
sence of 1,3-dichloropropene residues in raw agricultural
commodities (RAC's), a Data Call-in Notice has been sent to
the registrant requesting appropriate residue and plant
metabolism data. These data will be submitted to the Agency
in approximately 12 months. Until the data are submitted and
reviewed, a dietary risk assessment cannot be completed.
3. Worker Exposure And Risk
A risk assessment has been conducted for workers involved in
.the use of 1,3-dichloropropene. This analysis is based on
exposure through 100% inhalation of the pesticide.
During the handling and application of 1,3-dichloropropene,
dermal exposure is not expected because closed systems and
protective clothing are required for the handling and appli-
cation of the chemical. In case of equipment failure, dermal
exposure is possible.
The QI* [the cancer potency estimate in terms of human equi-
valence] for 1,3-dichloropropene was calculated as 1.75 x
.l.pr^.x (mg/kg/day)'1 . (This Gh* was generated using the oral
•"oneqgenicity study on rats). In order to assess potential
human risk from exposure to this chemical, the average life-
time exposure in mg/kg/day is multiplied by the Q]_* of 1.75 x
10"1 x (mg/kg/day)-1. This is the formula which was used to
estimate risk to workers exposed to 1,3-dichloropropene
(Risk = Exposure x Q]_*).
Because the cancer potency is based upon oral studies whereas
the exposure to workers is based on inhalation, the risks cited
in Table 4 may not be true risk levels.
The registrant is conducting an oncogeniclty study through the
inhalation route which may refine the theoretical risk
calculations cited in Table 4 for 1,3-dichloropropene.
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3/1
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B. PRELIMINARY RISK ANALYSIS
The Agency Is concerned about the oncogenic potential of 1,3-
dichloropropene and has assessed oncogenic risk to workers involved
in applying, handling, and storing of this chemical. The Agency
has determined that because of oncogenic effects in laboratory ani-
mals and potential exposure to workers, 1,3-dichloropropene meets
or exceeds the risk criterion set forth in 40 CPR 154.7(a)(2).
Therefore, the Agency has initiated a Special Review on 1,3-
dichloropropene.
1. Oncogenicity Studies
The National Toxicology Program (NTP) conducted oncogenicity
bioassays with orally administered Telone II (technical
1,3-dichloropropene) in rats and mice. In the rat oncogenicity
study, 1,3-dichloropropene was observed to produce tumors
of the forestomach, liver, mammary gland, thyroid gland,
and adrenal gland in one or both sexes of animals. In the
mouse oncogenicity study, 1,3-dichloropropene produced
tumors in the forestomach, urinary bladder, lung, and
liver in animals of one or both sexes, EPA evaluated this
tumorigenicity data for compound-related effects, and
developed a weight of the evidence position concerning the
chemical's oncogenic activity.
a. Rat Oncogenicity Study.
In the NTP F344 rat study, Technical 1,3-dichloropropene
was administered for 104 weeks at doses of 0, 25, and
50 mg/kg/day. A total of 77 animals/ sex were used
for each dose group. The following incidence patterns
of tumors suggestive of "a compound-related effect were
observed in male and/or female rats (Table 1).
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Table 1. Incidence Patterns of Tumors Observed in Male and
Female Rats Administered 1,3-dichloropropene
Tumor Site
and Type
Sex
Dose (mg/kg/day)
0
25
50
Forestomach
squamous cell papillona M
1/77 (1%)
0/77 (OS)
1/77 (1%)
2/77 (3%)
13/77 (17%)*
8/77 (10%)*
squamous cell carcinoma M 0/77 (1%) 0/77 (1%) 4/77 (5%)
squamous cell papilloma
and carcinoma combined
Liver ' '
neoplastic nodules
M 1/77 (156) 1/77 (156) 17/77 (22%}*
M 1/77 (156) 6/76 (856)
F 6/75 (856) 8/77 (1056)
8/77 (10.456)*
12/77 (16%)
hepatocellular carcinoma M 0/77 (056) 0/76 (056) 1/77 (1.350
neoplastic. nodules and
carcinoma combined
Mammary Gland
adenoma or fibroma
Thyroid Gland
follicular cell adenoma
or carcinoma
Adrenal Gland
pheochrcmocytoma
* = p < 0.05 Fisher's Exact
M 1/77 (156) 6/76 (85?) 9/77 (11.7%)*
F 17/61 (27%) 23/63 (37%) 28/64 (44J6)
F 0/75 (0%) 2/77 (3%) 5/77 (6%)
M 4/77 (5%) 14/77 (1856)* 10/76 (13%)
Test.
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Forestomach; Statistically significant increases in
squamous cell papillomas were found in high dose male
and female rats, and significant increases in squamous
cell papillomas and carcinomas (combined) were found
in high dose male rats.
Liver: Statistically significant increases in
neoplastic nodules, and in neoplastic nodules and
carcinomas (combined) were found in high dose male
rats.
Mammar; Gland and Thyroid Gland: Positive trends for
mammary gland adenomas or fibromas and for thyroid
gland follicular cell adenomas or carcinomas were
observed in female rats. None of the observed increases,
however, were statistically significant. No historical
control information on these tumor types was available.
Adrenal .Gland; An elevated incidence of pheochromo-
cytomas was observed in male rats receiving both doses.
Only the tumor incidence seen at the lowest dose tested
was statistically significant and a dose-response
relationship was not evident. No historical information
was ava?.able.
b. Moust icogenicity Study.
In th N.P B6C3P1 mouse study, 1,3-dichloropropene
(same technical formulation as used for the rat study)
was administered for 104 weeks at doses of 0, 50, and
100 mg/kg/day. A total of 50 animals per sex were
used for each dose group. This study has limited use-
fulness for two reasons: (1) animals were not randomized
and (2) over 50 percent of the male control mice died
near the end of the first year of the study. The
following incidence patterns of tumors suggestive of a
compound related effect were observed in male and/or
female mice (Table 2).
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Table 2. Incidence Patterns of Tumors in Male and/or Female Mice
Administered 1,3-dichloropropene
Tumor Site
and Type
Porestomach
squamous cell papillcma
squamous cell carcinoma
squamous cell papillcmas
and carcinomas combined
i
Urinary Bladder
transitional cell
carcinomas
Lung •'"•"•'.'••''
adenomas
carcinomas
adenomas and -carcinomas
cxi bined
Liver
adenomas
carcinomas
adenomas and carcinomas
combined
Dose (mg/kg/day)
Sex
M
P
M
P
M
P
M
P
M
P
M
P
M
P
M
P
M
P
M
F •
0/50
0/50
0/50
0/50
0/50
0/50
0/50
0/50
1/50
0/50
0/50
2/50
1/50
'2/50
1/50
0/50
4/50
1/50
5/50
1/50
0
(0%)
(056)
(056)
(056)
(0%)
(0%)
(0%)
(056)
(2%)
(0%)
(0%)
(456)
(2%)
(456)
(256)
(056)
(8%)
(256)
(10%)
(256)
50
2/50
1/50
0/50
0/50
2/50
1/50
0/50
8/50
11/50
3/50
2/50
1/50
13/50
V50
1/50
5/50
6/50
3/50
7/50
8/50
(W
(256)
(056)
(056)
(456)
(256)
(056)
(1656)*
(2256)
(656)
(456)
(256)
(2656)
(856)
(255)
(1056)
(1256)
(656)
(1456)
(1656)
Historical
100 Incidence
3/50
2/50
0/50
2/50
3/50
4/50
2/50
21/48
9/50
8/50
3/50
0/50
12/50
8/50
3/50
3/50
10/50
0/50
13/50
3/50
(656)
(456)
(056)
(4%)
(656)
(8%)
(456)
(4450*
(18%)
(1656)*
(656)
(056)
(2456)
(1656)*
(650
(6?)
(2055)
(05?)
(2656)
(6%)
0.6%
0.-3%
0.
0.
0.
0.
1%
1%
656
656
0%
0%
9.
3.
5.
1.
14,
4.
12.
4.
20.
2.
31.
6.
1%
356
455
5%
3%
7%
3%
056
5%
956
456
855
* » p < 0.05, Fisher's Exact Test. The Fisher's Exact Test was not performed
in males due to an insufficient number of males in the control group.
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Forestomach; 1,3-dichloropropene produced the following
changes In forestomach tumor pathology: (1) dose-related
Increases in squamous cell papillomas in male and
female rats at 50 and 100 nig/kg/day; (2) an increase in
squamous cell carcinomas in females at 100. mg/kg/day (no
carcinomas were seen in male mice); and (3) dose-related
increases in squamous cell adenomas and carcinomas
(combined) in males and females at 50 and 100 mg/kg/day.
The increased incidences of squamous cell papillomas
and carcinomas appeared to be compound-related since
neither tumor type was found in the concurrent control
animals of either sex, and both tumors occurred only
at very low Incidences In the NTP historical control
data provided.
Urinary Bladder; Increases in transitional cell
carcinomas occurred in male mice at the 100 mg/kg/day
dose level and in female mice at the 50 and 100
mg/kg/day dose levels (the increases In female were
dose-related and statistically significant at both
dose levels). No transitional cell carcinomas were
found in either the concurrent control animals or In
the NTP-provided historical control data for either
sex of mice.
Lung; In males, an increase in the incidences (not
strictly dose-related) of adenomas and of- adenomas and
carcinomas (combined) was found in the 50 and 100
mg/kg/day dose groups as compared to the concurrent
control rates and the NTP provided historical control
rates,. In females, a dose-related increase in the
incidences of adenomas and of adenomas and carcinomas
(combined), was observed, and the oncogenlc responses
were statistically significant at the 100 mg/kg/day
dose level.
Subcutaneous Injection
Thirty female HarlCR Swiss mice received weekly subcu-
taneous injections of cis-1,3-dichloropropene (3 mg/mouse)
in 0.05 ml trioctanoin in the left flank. The duration
of the test was 77 weeks. There was an increased
incidence of fibrosarcomas at the site of Injection.
Six out of thirty mice treated with 1,3-dichloropropene
developed the neoplasm as compared to 0/100 control
animals.
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2. Weight of the Evidence Regarding Oncogen Potential
The Agency considered the following facts regarding toxi-
cology data on 1,3-dichloropropene to be of importance in
a weight of evidence determination of oncogenic potential.
a. 1,3-dichloropropene when administered by gavage to rats
at the highest dose level tested (50 mg/kg/day), is
associated with significantly elevated incidences of
(a) forestomach squamous cell papillomas in males and
females, (b) forestomach squamous cell papillomas and
carcinomas (combined) in males, and (c) liver neoplastic
nodules in males. The increased incidence of forestomach
tumors was accompanied by a positive trend in the in-
cidences of forestomach basal cell hyperplasia in both
male and female rats of both treated groups. There
were also other tumors in rats, but the changes were
either not statistically significant and/or did not
occ'ur in a dose-related manner.
1 b. 1,3-dichloropropene when administered by gavage to mice,
is associated with elevated incidences of: (a) fore-
stomach squamous cell papillomas in males and females,
(b) forestomach squamous cell papillomas and carcinomas
.-. (combined) in females (c) urinary bladder transitional
'" '' . cell carcinomas in males and in females; (d) lung
• adenomas in males and females; and (e) lung adenomas
and carcinomas (combined) for males.
c. EPA considered the possibility that stomach tumors
produced by 1,3-dichloropropene in rats and mice in
the NTP studies could have been attributable to the
presence of a stabilizer, epichlorohydrin, in the
technical 1,3-dichloropropene formulation.
Epichlorohydrin has been demonstrated to produce similar
types of forestomach neoplasms (squamous cell papillomas
or carcinomas) in rats in non-NTP studies following oral
administration (Konishi, et al., Gann 71.: 922-923, 1980;
Wester et al., Report No. 627805 005, Rijtsinstituut
voor volksgezonheid en millleuhyglene, 1984).
Two lines of evidence suggested that the oncogenic
responses produced by 1,3-dichloropropene were not
entirely due to the presence of epichlorohydrin. First,
1,3-dichloropropene produced neoplasms other than fore-
stomach squamous cell papillomas and carcinomas in rats
in the NTP study (e.g., increased liver neoplastic
nodules and positive trends for mammary gland adenomas
or fibromas and thyroid gland follicular cell adenomas
and carcinomas); these tumor types were not reported to
be produced by epichlorohydrin (Konishi et al., 1984).
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Second, the doses of epichlorohydrin administered in
the NTP studies were low (i.e., only 1% of the total
daily.doses of 1,3-dichloropropene). The maximum
daily doses (given only 3x/week) of epichlorohydrin
administered to rats and mice would not have exceeded
0.5 and 1.0 mg/kg, respectively. These doses are lower
than those (approx. 37.5 to 75 mg/kg/day in drinking
water and 2 mg/kg/day via gavage, given 5 days/ week)
reported to cause forestomach tumors in the non-NTP
studies (Konishi et al., 1980; Wester et al. , 1934).
d. 1,3-dichloropropene, when administered by subcutaneous
injection to Swiss mice, is associated with increased
incidences of fibrosarcomas at the site of injection.
The injections were given once a week for a duration of
77 weeks. Under the conditions of the experiment, it
may be concluded that I,3-dichloropropene increased the
incidence of this neoplasm at the site of injection.
e. Positive results in mutagenicity tests support the onco-
genicity findings. 1,3-dichloropropene has been found
to be a direct acting mutagen in several tests utilizing
prokaryotic cells. The compound produced positive
res.ults for gene mutation in several microbial strains
(e.g., TA-1535, TA100, TA-98 and TA-1978) both in the
presence and absence of metabolic activation, while
negative results were obtained in a few other tests
(e.g., reverse mutation assay with E. coli B/r Wp2,
and mouse host mediated assay with S. typhimurium G46).
In addition, 1,3dichloropropene produced positive re-
sults for DNA damage/repair in a nonactivated recombi-
nation assay using B_._ subtilis I'M5 and H17 strains.
f. Dichloropropene (cis-, trans-1,3-dichloropropene) bears
a structural resemblance to several short chain halogen-
ated hydrocarbon compounds that are known oncogens (e.g.,
ethylene dibromide and vinyl chloride monomer). In the
case of ethylene dibromide, the same type of tumor
response as produced by dichloropropene has been reported
(IARC _15_: 195-209, 1977), namely forestomach squamous
cell carcinoma in rats and mice after oral administration
The production of these forestomach tumors by ethylene
dibromide occurred in the absence of epichlorohydrin as
a possible contaminant. In the case of vinyl chloride,
lung adenomas and/or adenocarcinoma have occurred in
rats and mice following inhalation exposure (IARC
7_:291-318, 1974; IARC 1_9_: 377-438, 1979). Similar
pulmonary tumors are produced by 1,3-dichloropropene
in rats and mice after oral administration.
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3. Potency Estimate and Formula for Risk Estimation
The results from the two NTP chronic feeding studies in rats
and mice indicate that increasing doses of 1,3-dichloropropen
are associated with increasing tumor rates in both sexes of
both species. It appears that male rats are the most
sensitive in that increasing doses of the chemical produces
significantly increasing numbers of either forestomach,
liver, adrenal, or thyroid tumors.
The multistage model was used to -determine the estimates of
oncogenic potency of 1,3-dichloropropene in the two species
of experimental animals. Review of the data indicates that
.male rats were the most sensitive to 1,3-dichloropropene in
developing tumors of either the forestomachj liver, adrenal
or thyroid gland. The estimated cancer potency (Qi*) using
these data was calculated to be 3.3 x 10~2 (mg/kg/day)-1.
This potency for male rats is converted to human equivalence
by (1) converting the diet of a rat in ppm. to mg/kg/day and
.then (2) converting the rat dose in mg/kg/day to human
equivalence by using a surface area correction:
(Human weight)1/3
(Rat weight)
The resulting Q-^* in human equivalence is 1.75 x 10"1
(mg/kg/day)"I. In order to assess potential human risk
from exposure to-1,3-dichloropropene, the average lifetime
exposure in mg/kg/day is multiplied by the Q]_* of
1.75 x 10"1 (mg/kg/day)'1. This is the formula which
was used in the1- next section to estimate risk to workers
exposed to 1,3-dlchloropropene(Risk = Exposure x Q]_*).
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• - 15 -
4. Exposure Analysis and Risk Assessment
a. Inhalation Exposure
On August 22,'1985, Dow Chemical Company submitted
exposure data from field monitoring reports from use
of 1,3-dichloropropene.
•The studies measured the worker exposure to 1,3-
dichloropropene during several types of activities as-
sociated with use of the chemical. Nine valid studies
were evaluated. Sampling were done in California and
Florida.. Table 3 is a summary of the data from the 9
valid studies. The exposure was estimated for the
inhalation route only.
The data are arranged according to job function or
time of field monitoring. From these data, an annual
exposure estimate is calculated. The resulting estimate
is in the last column of the table and is expressed in
mg/kg/year. In the assessment, EPA assumed that the
breathing rate is 29 liters per minute and a worker
weighs 70 kg. The exposure in days/year is assumed to
be for a private applicator: the exposure for a com-
._. mercic !• applicator would be expected to be higher.
b. Non-L :ary Risk Assessment
The /. ,3ncy has calculated the worker non-dietary poten-
tial oncogenic risk from exposure to 1,3-dichloropropene
by multiplying the exposure in mg/kg/day for various
activities by the potency or Qi* of 1.75 x .10~1
(mg/kg/day)~1. This represents a high level of
oncogenic potency.
It is important to note that the exposure estimates
summarized in Table 4 are only for the inhalation
route. The measure of risk is based upon 100%
inhalation exposure.
The risk estimates represent the upper 95% bound on
the tumor response in the two laboratory animal
experiments; the 95% bound is calculated primarily to
account for uncertainties inherent in the animal
experiments. The risks range from the order of 10~2
to 10~5 for the various work activities and are shown
in the last column of Table 4.
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- 16 -
Table 3. Inhalation Exposure Estimates for
Workers Exposed to 1,3-dlchloropropene
Based on 9 Studies In California from
•Dow Chemical Company.
Activity
Bulk Transfer
Storage Areas
Loading
Highway Transport
Appl lea to r-Trac tor
Post Treatment
24 hrs
36 hrs
72 hrs
Downwind
mg/1
Range of
Exposure
0.006-0.3
0.0005-0.06
0.005-0.01
0.00005
0.001-0.01
0.0007-0.03
0-0.02
0-0.02
0
0.002
Hourly
Exposure
6 29 1/min
10.4-522
0.87-104
8.7-17
0.09
1.7-17
1.2-52
0-35
0-35
0
3.48
Hours/
Day*
0.5
8
0.5
8
5
5
0
0
0
2***
mg/
day
5.2-261
7-832
4-8.7
6.96
9-87
6-260
0
0
0
6.96
Days/
year*
2
2
2
10
2
2
0
0
0
2
mg/
year
10.4-522
14-1664
8-17.4
10
18-170
12-520
0
0
0
13.92
rag/kg/
year**
0.15-7.5
0.20-23-99
0.1-0.25
0.99
0.25-2.4
0.17-7.4
0
0
0
0.199
* Use practices vary. EPA estimated a total of about 10
hours total/yr for an average crop (This can vary: cotton-60 -
hrs/yr, sugar beets 23 hrs/yr, arid vegetables about 9 hrs/year.)
At 10 hrs/year for average farm, two days would be required.
The highway transport is an estimate assuming a full day of
driving and 10 days/year during treatment season. The post
treatment concentration is a good estimate for the roller
treatment which follows the treatment immediately to seal-in
the fumigant. EPA assumes no significant exposure occurs during
aeration and planting as these operations are done 7~l4 days
after application.
** Based on a 70 kg man
*** Assuming limited high concentration downwind for two hours.
Vapor pressure for 1,3-dichloropropene is such that it volatilizes rapidly into
the air after soil injection. The down wind drift of this pesticide includes
person(s) living adjacent to treated fields.
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-17-
c. Dietary Exposure
The pesticide 1,3-dichloropropene is currently regis-
tered as a preplant nematicidal fumigant on soils to be
applied to a number of raw agricultural commodities
(e.g., vegetables, field crops, citrus, fruit and nut
trees). These uses were registered as nonfood uses and
thus there are currently no tolerances established for
1,3-dichloropropene. The uses registered were considered
nonfood uses at the time because the pesticide was
applied to the soil prior to planting and residues in
the resulting crops were not expected.
Available residue data are inadequate to make a deter-
mination if residues of 1,3-dichloropropene, its metabo-
lites, or formulation impurities will result in raw
agricultural commodities as a result of use of 1,3-
dichloropropene. A Data Call-in Notice was sent in
June 1986, to the registrants, requesting appropriate
residue and plant metabolism data. Plant metabolism data-
are to be received by March 1988, and residue data by
March 1989.
Until these data are submitted and reviewed, an accurate
dietary risk assessment cannot be carried out.
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Table 4. Inhalation Exposure and Risk Estimates for Workers
Exposed to 1,3-dichloropropene for Various Activities
Activity
Bulk Tr, --inn for
Storage1 Areas
Loading
Highway
Trari.sixirt
Applicator
Tractor
Post Treatment
24 Hours
36 Hours
72 Hours
Downwind **
EXPOSURE ESTIMATE
(1)
Observed Daily
Exposure
mg/ kg/day
MIn . Max .
7.46x10-2 3.73
9.94x10-2 11.93
6.21x10-2 1.24x10-1
9.94x10-3
1.24x10-1 1.24
8.7x10-2 3-73
0
0
0
9.94x10-2
(2)
Days
Exposed
per year
2/365
2/365
2/365
10/365
2/365
2/365
0/365
0/365
0/365
(2/365)
(3)
*LADD = (l)x(2)x
(35 Work Yrs.)
(70 Yr Life)
mg/kg/day
Low High
2.04x10-4 1.02x10-2
2.72x10-^ 3.27x10-2
1.70x10-4 3.40xl(H
1.36x10-4
3.40x10-4 3.40x10-3
2.38x10-4 1.02x10''-
0
0
0
2.72xl(r'l
RISK ESTIMATE
Upper Bound on Risk
= (LADD x Q]/)
= C(3)xl. 75x10-1
(mg/ kg/day )~1
Low High
3.6x10-5 1.8x10-3
4.8x10-5 5.7x10-3
3.0x10-5 5.9x10-5
2.4x10-5
5.9x10-5 5.9x10-4
4.2x10-5 1.8x10-3
I
0
0
0
4.8xK)-5
Rounded
Risk Range
10-5 - 10-3
10-5 - 1Q-2
10-5 - 10-4
10-5
10-5 - iQ-3
10-5 - io-3
0
0
0
10-5 - 1Q-4
* LADD = Lifetime Average Dally DMSO
** Vapor pressure for 1,3-dlchloropropene Is such ttiat It volatlliz-
the air after soil Injection. The down wind drift of this pestii
person(s) living adjacent to treated fields.
rapidly Into
ie Includes
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-19-
C. OTHER SCIENCE FINDINGS
1. 1, 2-Dichloropropane Studies
The NTP has conducted two oncogenicity Studies with 1,2-
dichloropropane, an impurity in 1,3-dichloropropene, using
rats and mice. EPA has completed a preliminary review of
these studies. The results indicate that 1,2-dichloropropane
is an oncogen and may pose a risk to humans. The summary
within the NTP studies states that 1,2-dichloropropane is:
(1) negative in male rats; (2) marginally positive for
mammary tumors in female rats, but is designated as equivocal
because of a high mortality rate; and (3) positive in male
and female mice for liver tumors. The Agency's preliminary
review indicates that the Qj* or oncogenic potency in terms
of human equivalence is 6.3xlO~2 (mg/kg/day)~1 for males and
2.25x10-2 (mg/kg/day)-1 for females.
However, the Agency believes that 1,2-dichloropropane is not
of major toxicological concern for the following reasons:
(1) 1,2-dichloropropane was an impurity in the chronic test
formulations of 1,3-dichloropropene, presenting a minimal
oncogenic risk when compared to the parent compound, and
..(2) its Q1* is ten times lower than the Qx* (1.75 x 10"1) for
;'-l, 3-dlchloropropene.
2. Teratology Studies
Two inhalation teratology studies were performed with 1,3-
dichloropropene in rats and rabbits. In the rat study, no
teratogenic effects were observed, although maternal toxicity
occurred at all dose levels. Developmental toxicity (delayed
ossification of vertebral centra) occurred at the highest
dose (120 ppm). In the rabbit study maternal toxicity
occurred at the 2 highest dose levels (60 ppm and 120 ppm)
but no evidence of embryo fetotoxicity was apparent.
3. Reproductive Studies
A reproductive study with 1,3-dichloropropene is lacking at
the present time. However, the registrant is conducting a
two generation reproduction study in rats by the inhalation
route. ' The study will be finalized in July 198?.
4. Metabolism Studies
Two limited metabolism studies in rats have been performed.
In one study, orally administered radioactive (Cl^) cis- and
trans-1,3-dichloropropene was found to be excreted primarily
in the urine over 4 days. Negligible amounts of radioactivity
were found in the gastro-intestinal tract, skin, and carcass.
No information on urinary or fecal metabolites was provided.
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-20-
In the other study, orally administered radioactive cis-di-
chloropropene isomer yielded methyl-N-acetyl-S[(z)—3-chloro-
prop-2-enyl] cysteine as the main urinary metabolite. These
two studies do -not fulfill EPA'-s regulatory requirements for
a metabolic study because additional data are required as to
the disposition of the chemical.
5. Ground water Concerns
Available data indicate that 1,3-dichloropropene, the major
component of technical Telone II®, does leach to ground
water when It is present in the most sensitive environment
(shallow ground water and sandy soils of low percentage
organic matter in areas of high rainfall or irrigation) .
However, the relative hydrolytic instability of the parent
compound would mitigate the potential for extensive contami-
nation. Due to the high use rates involved (43 to 968 Ibs
ai/acre), all impurities and metabolites in the technical
product are of concern.
There are very limited data on the chemical properties and
environmental fate of 1,3-dichloropropene, and limited
monitoring information available on the other components or
degradates of this compound. Generally, data from monitoring
• studies focusing on 1,3-dichloropropene and 1,2-dichloropropan
Indicate frequent findings of 1,2-dichloropropane in a variety
of environmental settings and less frequent findings of the
major compound.
Data indicate that 1,2-dichloropropane, an impurity in tech-
nical Telone II, does have the potential to leach to ground
water. The chemical structures of this and other impurities
appear to be non-reactive and the compounds appear to be
persistent and mobile. Information from the California State
Water Resource Control Board shows that 1,2-dichloropropane
is being found in-both shallow and deep wells throughout the
state. Monitoring data from Maryland, Massachusetts, New
York, Connecticut and Washington also are positive for the
chemical in ground water.
6. Acute Toxicity
1,3-dichloropropene is classified as Toxicity Category II
for oral toxicity and primary eye irritation, and Toxicity
Category III for dermal irritation.
7. .Ecological Effects
Available toxicology data show that 1,3-dichloropropene is
of low to moderate toxicity to birds and moderate toxicity
to fish and aquatic invertebrates.
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-21-
D. TOLERANCE ASSESSMENT
The Agency cannot conduct a tolerance assessment on 1,3-dichloro-
propene at this time because it previously considered all of the uses
as non-food uses. No tolerances or exemptions from tolerances for
residues of the chemical in or on food/feed commodities have been
established in the United States.
Current residue data are inadequate to determine if residues of
1,3-dichloropropene, its metabolites, or impurities, will occur in
raw agricultural commodities following its use. Data on the meta-
bolism of 1,3-dichloropropene in crops and on residue storage
stability are required. The additional data will be used to more
fully assess possible residues in food and feed crops and may lead
to additional data requirements in residue chemistry.
If these data indicate that residues of 1,3-dichloropropene are
taken up by the crops, the establishment of tolerances will be
necessary. The current toxicological studies do not meet the data
requirements necessary to establish tolerances for this chemical.
Therefore, the following toxicology tests may be required: chronic
feeding-studies us in?, two species, oncogenicity studies by the oral
route usi.ng' two 'sr ?•- Les, a two generation reproduction study by the
oral -route .and • te?- . ology studies by the oral route using two
species. Also, \ >e data may be used to determine effects of
dietary exposure rough drinking water since the compound, its
metabolites and j pu.ities are potential ground water contaminants.
The Agency will not grant any pending or new tolerances for 1,3-
dichloropropene until the required data are submitted and reviewed.
International Tolerances
Presently, there are no tolerances for residues of 1,3-dichloropropene
in Canada, Mexico, or in the Codex Alimentarius.
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-22-
IV. REGULATORY POSITION AND RATIONALE
A. POSITIONS AND RATIONALE
Based on the review and evaluation of all available data and other
relevant information on 1,3-dichloropropene (Telone II®), the Agency
has made the following determinations:
1. The Agency has placed 1,3-dichloropropene in Special Review
because the chemical has met the risk criterion for onco-
genicity in 40 CFR, Section 154.7 (a) (2) . The Agency has
determined that the chemical may induce' an oncogenic effect
in humans and that this effect is of concern because of the
potential worker/applicator exposure. (See Part III, Section
B. for a discussion of the oncogenic potential and exposure
estimates).
Rationale: The Agency has categorized 1,3-dichloropropene as a
probable human carcinogen. Available chronic toxicity data
also show that this compound is oncogenic in both sexes of
rats and mice. Interim regulatory measures in this regis-
tration standard will reduce risk to acceptable levels during
the period necessary to complete the Special Review.
... 2.. The .Agency is classifying the 1,3-dichloropropene products for
..,l':Res.tricted Use". The products will be for retail sale and
use'only by Certified Applicators or persons under their
direct supervision and only for those uses covered by their
certification.•
Rationale: The toxicological data and its oncogenicity indicate
that 1,3-dichloropropene is extremely hazardous. The Agency
believes that restricted use is necessary to protect mixer/
loaders and applicators from inhalation exposure to this
pesticide.
3. The Agency is continuing on an interim basis, the current
reentry interval of 72 hours for the end-use products (EPs)
of 1,3-dichloropropene.
Rationale: There are no data on 1,3-dichloropropene to estimate
reentry exposure to workers entering treated areas. In most
cases, the Agency would set a reentry interval of 24 hours
during which time reentry is prohibited without protective
clothing. However, because 1,3-dichloropropene is e"xtremely
hazardous, the product is currently labeled with a 72 hour
interval. The Agency will continue to use the 72 hour reentry;
interval until data are submitted to support a final interval
When the data are submitted, (40 CPR Sec. 158.140 Reentry
Protection Data Requirements), the Agency will evaluate the
exposure data and determine whether "the 72 hour interval
should be changed.
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-23-
A. The Agency is continuing to require protective clothing and
equipment specified on existing labeling. The type of pro-
tective clothing and equipment required includes cover alls
gloves, heavy-duty footwear, safety goggles, and a mask or
respirator approved for use with 1,3-dichloropropene.
Rationale: In order to minimize the exposure of workers to 1,3-
dichloropropene, the Agency will require the protective clothing
and equipment whenever high concentrations of 1,3-dichloropropene
vapors might be expected (mixing/ loading, application and
spillage sites).
5. The Agency will not grant any pending or new tolerances for
1,3-dichloropropene until the required data are submitted and
reviewed. Current residue data are inadequate to determine
if residues of the pesticide, its metabolites, or impurities
will occur in raw agricultural commodities (RAC's) following
its use.
Rationale: Previously the Agency considered the uses of 1,3-
dichloropropene on.RAC's as non-food uses. No tolerances or
exemptions from tolerances for residues of 1,3-dichloropropene
in or on food/feed commodities have been established.
5. The' Agency is requiring environmental fate data including a
protocol for ground water monitoring studies on technical
Telone II®, its metabolites and impurities including 1,2-
dichloropropane, in order to clarify its potential to conta-
minate ground water. If the required data indicate a high
potential for ground water contamination, the Agency may
place 1,3-dichloropropene in special review for this reason
as well.
Rationale: Data indicate that 1,2-dichloropropane, an impurity
in technical Telone II® reaches ground water under a variety
of conditions. Due to the high use rates involved in the
application of 1,3-dichloropropene (43 to 968 Ibs. ai/acre),
the Agency is concerned with all impurities in the technical
product, and with metabolites that may be present in ground
wa t e r.
1,3-dichloropropene, the major component of technical
Telone II®, leaches to ground water when it is present in
the most sensitive environment (shallow ground water and
sandy soils of low percentage organic matter in areas of
high rainfall or irrigation).
-------
7. The Agency will require a cancer hazard warning statement on
the label of 1,3-dichloropropene products. Refer to the
labeling Section D. under Part IV. for wording.
Rationale; The Agency has categorized the pesticide as a probable:
human carcinogen. Therefore, the cancer warning statement
is intended to provide informed consent, and to encourage
workers to comply with all of the directions for use of
1,3-dichloropropene products in order to minimize exposure
to workers.
8. The Agency will not impose warning statements on MPs and EPs
labels for non-target aquatic organisms and endangered species
until the environmental fate data for 1,3-dichloropropene are
received and reviewed.
.Rationale: 1,3-dichloropropene is low to moderately toxic to
waterfowl and upland game birds. It is moderately toxic to
coldwater fish, moderately toxic to warmwater fish and
moderately toxic to freshwater invertebrates.
Based upon currently available data, endangered species
labeling statements are not warranted. If the environmental
fate or other data indicate a potential hazard to endangered
species/,.-.the Agency will request a consultation with the
\ .Off.ice -of. Endangered Species, Department of the Interior.
9. While the data gaps are being filled and the Special Review
is underway, currently registered MPs and EPs containing
1,3-dichloropropene as the sole active ingredient may be
sold, distributed, formulated and used, subject to the terms
and conditions specified in this Standard. Registrants must
provide and agree to develop additional data, as specified in
the Data Appendices of this guidance document, in order to
maintain existing registrations.
Rationale: Under PIPRA, the Agency may choose not to cancel or
withhold pesticide registration if data are missing or inade-
quate (See PIFRA sections 3(c)(2)(B) and 3(c)(7) or because
a chemical is undergoing Special Review.
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory
changes are necessary.
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• -25-
B. CRITERIA FOR REGISTRATION UNDER THIS DOCUMENT
To be subject to this guidance document, manufacturing-use -products
must meet the following conditions:
. 1. Contain l,<3-dlchloropropene as the sole active ingredient
and,
2.. Conform to the acute toxicity limits, product composition,
and use pattern requirements listed in Section E of this
document.
Registration of products subject to this document must comply with
all terms and conditions described in it, including commitment to
fill data gaps on a schedule acceptable to EPA and consistent with'
that required of the present registrant. All registrants and
applicants for registration under this document must follow the
instructions contained in this document and complete and submit
the appropriate forms.within the specified time.'
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Technical -grade products must contain at least 9^.0 percent 1,3-di-
chloropropene-as.the. sole active ingredient. Each manufacturing-use
product -formulation proposed for registration must be fully described
with an appropriate certificition of limits. In addition, the
active ingredient found in the manufacturing-use products must be
substantially similar to that in currently registered technical
products. Any manufacturing-use product not meeting these require-
ments '.fill be considered a new product and will not be registerable
under this guidance document.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and manu-
facturing-use products containing 1,3-dichloropropene, provided
that the product labeling bears appropriate precautionary state-
ments for the acute toxicity category in which each product is
placed.
3. Use Patterns
To be registrable under this Standard, manufacturing-use products
containing 1,3-dlchloropropene must be labeled for formulation
only into end-use products only for the commodities listed below.
The attached index entry lists all registered uses, as well as
approved maximum application rates and frequencies.
1,3-dichloropropene is registered for use as a preplant soil fumi-
gant on cotton, potatoes, tobacco, sugar beets, vegetables, apples,
stone fruits, citrus, grapes, floral/turf and certain ornamental
sites. For specific use patterns of 1,3-dichloropropene, please
refer to the Use Index/Appendix.
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-26-
D. REQUIRED LABELING
All manufacturing-use 1,3-dichloropropene products must bear appro-
priate labeling as specified in 40 CPR § 162.10, and below. The
Labeling Appendices contain additional information on labeling
requirements.
No pesticide product containing 1,3-dichloropropene may be'released
for shipment by a registrant or producer of that product after
October 30, 1987, unless the product bears an Agency amended label
which complies with the requirements of this Standard.
No pesticide product containing 1,3-dichloropropene may be distri-
buted, sold, offered for sale, held for sale, shipped, delivered
for shipment, or received and (having been so received), delivered
or offered to be delivered by any person after after October 30,
1988, unless the product bears an Agency amended label which complies
with the requirements of this Standard.
The following information must appear on the labeling within the
time limits specified above:
1. Ingredient Statement
The .ingredient statement for all MPs and EPs must list the
active-, ingredient as:
1 ,.3-Dichloropropene %
2 . Precautionary Statements
a. Manufacturing-Use Product Statements
All products intended for formulation into"end-use products mu|
bear the following statement:
"DANGER. Causes severe eye damage. May be fatal if inhaled,
absorbed through skin, or swallowed. Do not get in eyes, on
skin or on clothing. Wear chemical worker goggles, face
shield or safety glasses. Wash thoroughly with soap and
water after handling, and before eating and smoking".
"Do not discharge effluent containing this product directly
into lakes, streams, ponds, estuaries, oceans or public waters
unless this product is specifically identified and addressed
in a National Pollutant Discharge Elimination System (NPDES)
permit. Do not discharge effluent containing this product
into sewer systems without previously notifying the sewage
treatment plant authority. For guidance, contact your State
Water Board or Regional Office of the Environmental Protection
Agency".
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-27-
Cancer Hazard Warning Statement
" The use of this product may be hazardous to your health.
This product contains 1,3-dichloropropene which has been
determined to cause tumors in laboratory animals. Risks
can be reduced by closely following the use directions and
precautions, and by wearing protective clothing specified
elsewhere on this label."
b. End Use Product Statements
1) The following human hazard statements must appear on all
EPs labels:
"DANGER. Causes severe eye damage. May be fatal if inhaled,
absorbed through skin, or swallowed. Do not get in eyes,
on skin or on clothing. Wear chemical worker goggle.s,
face shield or safety glasses. Wash thoroughly with soap
and water after handling, and before eating and smoking."
"RESTRICTED USE PESTICIDE"
"For retail sale to and use only by Certified Applicators
or persons mder their direct supervision and only for those
•uses covt. d by the Certified Applicator's certification."
Cancer h ard Warning Statement
" The ut , of this product may be hazardous to your health.
This product contains 1,3-dichloropropene which has been
determined to cause tumors in laboratory animals. Risks
can be reduced by closely following the use directions and
precautions, and by wearing protective clothing specified
elsewhere on this label."
2) The following environmental hazard statement must appear on
all EPs:
"Do not contaminate water by cleaning of equipment or
disposal of wastes. In case of spills, properly dispose
of contaminated materials."
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-28-
3) The following precautionary statements must appear on all
EPs:
"Required clothing and equipment during the handling and
application of 1,3-dlchloropropene:"
"One-piece coveralls which have long sleeves and long pants
constructed of laminated fabric as specified in the USDA/
EPA Guide for Commercial Applicators.".
"Liquid-proof hat such as a plastic hard hat with a plastic
sweat band."
"Heavy-duty liquid proof (neoprene/synthetic) work gloves
and boots."
"Any article worn while handling 1,3-dichloropropene must
be washed before reusing. Immediately remove all clothing
which has been drenched or has otherwise absorbed 1,3-
dichloropropene from any spill. Dispose of contaminated
clothing in a sanitary landfill by incineration, or if
allowed by state and local authorities by burning. If
burned, stay out of smoke."
Field Reentry
"Workers entering the treated area for 72 hours after appli
cation of 1,3-dichloropropene must wear protective clothing
.Storage And Disposal Statements
"Pesticide wastes are toxic. Improper disposal of excess
pesticide is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label
instruc'tions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at
the nearest EPA Regional Office for Guidance."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product.- The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they-pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4'.:. . Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
29
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2, If eligiole for the formulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3 if you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
30
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic.data?
Generic data pertain to the properties' or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. who must submit generic data?
•All current registrants are responsible for submitting
generd'c. data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form. ' -
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
4 Registrations granted after issuance of this Standard
will be conditioned upon submission or citation of the data
listed in this Registration Standard.
31
-------
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comp..y with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted;
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
32
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3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a.certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company nare] offers to share in the burden of
producing the o- .a required pursuant to FIFRA sec.
3(c)(2}(B) in j [name of active ingredient] Registration
Standard upon rms to be agreed or failing agreement
to be bound b; oinding arbitration as provided by FIFRA
section 3(c)(. j(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and-submit the data.
4. You request a waiver of the data requirement. if
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. "A request for waiver-does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
33
-------
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either EPA's Pesticide Assessment Guidelines or the Reports
of Expert Groups to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the timeframe
for submission of the data, nor will extensions generally be
given to conduct studies due to submittal of inappropriate
protocol's:.-' •
F. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
in writing to the Office of Compliance Monitoring.
EPA will view failure to request an extension before
the response deadline as a waiver of any future claim that
there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline
for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome. Time extensions
may be considered when joint data development is planned,
34
-------
or when the Agency must approve a new or modified protocol
before the study can be begun,
A request for. an extension does not extend the timefrarae
for submission of the data. If EPA denies your request for
a time:extension and'you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
G. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden 'of clearly demonstrating to EPA that granting
such permission would be consistent with the Act.- The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
35
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section IV.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data)
or IV.D.6. (.cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
36
-------
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
37
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IX. INSTRUCTIONS FOR SU3MI5SIC.:
A. Manufacturing Use Products (MUPs) containing 1,3-
dichloropropene as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
rj. Cznfioential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submitto theProduct Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1 ) .
b. Two copies of any required product-specific data
(See Table B)/
c. Tnree copies of draft labeling, including the
container lac-el and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
38
-------
3. Within the times set forth, in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing 1,3-dichloropropene
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
2. Within the time frames set forth in Table A, you must
submit^to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason .a'hy test • i: elayed or aborted so that the schedule
cannot -be-met, r Jiately notify the Product Manager and
the Office of Con- iance Monitoring of the problem, the
reasons for the f ot~~em, and your proposed course of action.
C. End Use Products containing 1,3-dichloropropene as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
v
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
39
-------
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the.front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing 1,3-dichloropropene either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
E. Addresses
The required information must be submitted to the following
address:
'Henry. M. Jacoby
Product Manager (21)
Registration Division (TS-767C)
-.Office of Pesticide Programs
Unvironmental Protection Agency
401,, M St. , SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office o,f Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
40
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TGUIDE-1 .
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides, covered by thrs Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B ..contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to 2.n end use product ^
The data tables are aenerally organized according to the
following format:
1.... Data .Requirement (Column 1) . The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols sot cut in the Pesticide• • A-s&ee-s-nent Cui<2slir.cc,
which-are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield. VA 22161.
2. Test•Substance (Column 2). This column lists the composition
of 'the test-substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table,
3. Use pattern (Column 3} „ This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table,
41
-------
TGUIDE-2
4, Does EPA have data? (Column 4), This column j nrf.iraJr^.^ one
of three answers:
YES — EPA has data in its files that, completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY — EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
SPA"are ••inc-cssrpltt-tc. •'Kv-this-cocs, whs??*, tho data are
Clarified, or additional details of the testing submitted
by the original data submitter, the xiata may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
*- ~>* '-rC- .!.£.- 1 1 -A-JU.,-. -3 ~i- _ w*~*.~-.-»..»«t»-~i«*4- *-.-_ *.-K^% *3 94- a Til)"* T "-^H T?O A
i_o i. u j. j- j. j. j. >_ii<= vjuv.u j.^v^u j. i. Wilton w , >_/». v_nG sjcli-a WHl^U Cift\
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for. a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8, Footnotes (at the end of each table)- Self-explanatory.
42
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TABLE A
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROPROPENE I/
Data Requirement
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity/Disclosure
6.1-2 - Description of Beginning
Materials & Manufacturing
Process
6.1-3 - Discussion of Formation of
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Method for
Enforcement of Limits
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
All
All
All
All
All
All
Does EPA
Have Data? 2
N/A
N/A
N/A
N/A
N/A
N/A
Bibliographic
Citation
N/A
N/A
N/A
N/A
N/A
N/A
Must Addtl
Data be
Submitted?
No
Yes
Yes
Yes
Yes
Yes
Time Frame
for
Submission
6 months
6 months
12 months ro
12 Months
12 Months
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All
All
All
N/A
N/A
N/A
No
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
No
Yes
6 months
6 months
6 months
N/A 3/
6 months
-------
Data Requirement
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density,
or Specific Gravity
G3-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/ water partition
coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
64- 1 - Submittal of samples
Test
Substance
TGAI
TCAI or PAI
PAI
PAI
PAI
PAI
PAI -
TGAI, PAI
Use
Patterns
All
All
All
All
All
All
All
All
Does
Have
N/A
N/A
N/A
N/A
N/A
N/A
N/A
No
EPA Bibliographic
Data?2 Citation
N/A
N/A
N/A
N/A
N/A
N/A
N/A
-••
Must Addtl
Data be
Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No V
Time Frame
for
Submission
6 months
6 months
6 months
6 months
6 months
6 months ^-
6 months
_!/ The technical product is not a registered manufacturing-use product.
2/ Not applicable. Although product chemistry data may been submitted in the past, the Agency has determined that
these data must be resubraitted for each pesticide. New requirements have been introduced and previously submitted
data must be updated. Therefore bibliographic citations for the old data are not applicable.
3/ Not applicable because the technical is a liquid at room tanperature.
¥/ This compound does not require the submittal of samples .at this time.
-------
TABLK A
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLORQPROPENE
Data
§158.
171-2
171-4
171-4
Requirement
125 Residue Chemistry
- Chemical Identity
~ Nature of Residue
(Metabolism)
- Plants
- Livestock
- Res idue Analytical
Method
- Plant residues
Test Does EPA Bibliographic Must Addtl 'Time Frame
Substance Have Data? Citation Data be for
Submitted? Submission
TGAI Yes GS0328-001
. PAIRA ' Partially 00040721,
PAIRA & Plant No
Metabolites
TGAI and Metabolites Yes 00030385,
00033256,
00033258,
00033260,
00033263,
00039694,
00109291,
00109672,
00117045
No
00040722 Yes I/ March 1988
Reserved 2/
00033255 No 3/
00033257 to
00033259 -sr
00033262
00033264
00039695
00109420
00115214
- Animal residues
171-4 - Storage Stability
Data
TGAI and Metabolites
No
TGAI and Metabolites Partially
00033261
No 37
Yes V
March 1988
-------
Data Requirement
Test
Substance
Does EPA Bibliographic Must Addtl Time Frame
Have Data? Citation ( Data be for
Submitted? Submission
§158.125 Residue Chemistry - Continued
171-4 - Mc-ignitude of the Residue -
Residue Studies
- Crop Groups
— Crop Field Trials
— Processed Food/Feed
— Meat/Milk/Poultry/Eggs
- Potable Water
- Fish
- Irrigated Crops
- Food Handling
171-5 - Reduction of Residue
TEP
EP
TGAI or Plant
Metabolites
EP
EP
EP
EP
Residue of
Concern
Partially 00033255, 00033256 Yes 5/ March 1989
00033257, 00033258
00033259, 00033260
00033262, 00033263
00033264, 00039693
00039696, 00109672
00115214
No Reserved 6/
No Reserved 6/ ^f
No Reserved 6/
No Reserved 6/
No Reserved 6/
No Reserved 6/
No Reserved 7/
171-7 - Reasonable Grounds in
Support of Petition
No
Reserved 7/
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR 1,3-DICHLOROPROPENE
§ 158.125 Residue Chemistry - Continued
I/ Data are required depicting the distribution and metabolism of C^'C] 1,3-dichloropropene in soybeans and lettuce
harvested at regular Intervals which encompass seedling and mature growth stages following a single preplant soil
Injection application at 6 to 8 Inches below the soil surface with the 9^/J formulation at a rate sufficiently high
to permit complete characterization of l^C-residues. If a significant proportion of the terminal residues are
unextractable by the solvent(s) used, then analyses must Include hydrolysis and reextraction of plant residues to
determine the nature of bound or conjugated residues. Upon receipt of the data, an appropriate tolerance definition
(parent compound plus all metabolites of toxicologlcal concern) must be established with tolerances for residues
in or on all food/feed crops for which uses of this pesticide are registered.
2/ If real residues are found in feed-commodities, data depicting the metabolism of 1,3-dichloropropene in ruminants
and poultry will be required. If transfer of residues of 1,3-dichloropropene to ruminants and poultry tissue
occur, then appropriate feeding studies with these animals will be required.
3/ Additional data may be required depending on residues determined in the metabolism testing.
5/ Available data show that the storage stability of 1,3-dichloropropene in or on frozen plant samples Is poor after
75 days In frozen storage. The following data are required: the storage conditions and Intervals from harvest to
analysis of all plant samples used to obtain all residue data In this standard. The data must be accompanied by
stability data depicting the percent decline of all residues of concern in plant samples stored under the specified
conditions.
57 Available data are not adequate to determine the magnitude of terminal residues of 1,3-dichloropropene In or on
food/feed commodities because (i) dosage rates were unclear, (li) storage stability was poor, and (ill) much of
the data were generated on foreign sites. The following data will be required (if the radiolabeled metabolism
studies reveal detectible residues): representative commodities from each crop group listed in 40 CFR 180.34 (with
the exception of herbs and spices); asparagus, okra, cotton, flax, hops, peanuts, safflower, sugarcane, olives, |
persimmons, pineapple, and pomegranates must be treated preplant at representative geographic locations with the -
94% formulation according to the label directions at the maximum registered rate. Samples of all raw agricultural
commodities from each crop must be collected at the shortest interval after planting in which they could be used
for food or feed purposes. Since frozen storage stability is poor, samples must be analyzed as soon as possible
following collection. Tolerances reflecting maximum expected residue levels must be proposed or, if no measurable
residues are detected, the limits of detection must be proposed.
6/ These requirements are reserved until such time as data Indicate that the magnitude of residues of
1,3-dichloropropene at these sites pose concerns. , •
]_/ This requirement is reserved until such time as data- Indicate that residues of 1,3-dichloropropene are present
in food/feed commodities.
-------
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROPROPENE
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
§138.130 Environmental Fate
DEGRADATI ()N STUDIES-LAB:
161-1 - Hydrolysis
1'hotode)r, ro (1 at Ion
161-2 - In v;ater
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching and
Adsorption/
Desorptlon
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TGAI or PAIRA A,B,C Yes
TGAI or PAIRA A,B,C No
TGAI or PAIRA A,B,C No
TGAI or PAIRA A,B,C No
'JViAI or PAIRA A,B No
'RJA1 or PAIRA A,C No
TiJAI or PAIRA C No
TGAI or PAIRA C No
TGAF or PAIRA A,B,C No
TKP No
TKP No
Ace. 0261118
Must Addtl
Data be
Submitted?
Time Frame
for
Submission
No
No I/
No I/
Yes
Yes
No 2/
Yes
Yes
Yes
9 months
27 months
27 months
27 months
12 months
co
No I/
Yes 3/ 27 montlio
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROFROPENE '
Data Requ'l r ( Mierit
Test
Substance
Use Does EPA Bibliographic
Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
( Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
TEP
TliP
TEP
TEP
TEP
PAIRA
TEP
TEP
THAI or PAIRA
TEP
A,B No
C No
No
No
A,B,C No
A,C No
A,C No
A,B,C No
A,B,C Mo
A,B,C No
Yes 3/
Yes
No 57
No V
Reserved 6/
Yes
Reserved If
No 5/
No 5 /
No 5/
27 months
27 months
50 months
39 months ^*~
Organisms
SPECIAL STUDIES;
- Ground Water
Monitoring
PAIRA
A,B,C
No
Yes 8/
15 months
-------
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROPROPENE
§158.130 Environmental Fate - Continued
I/ Data are not required because of application of this pesticide by soil injection.
2_/ Data are not required if acceptable anaerobic aquatic metabolism data are submitted.
3/ Prior to initiating test, submit protocol by April 30, 1987 to the Agency for review and approval. Combine testing
for volatility and dissipation from soil on three or more soil types by continuously sampling air near the surface
of treated areas. Report residues of 1,3-dichloropropene and 1,2-dichloropropane, beginning at 0, and 12 hours,
and 1, 3, 4, 7, 14, and 21 days or until the dissipation curve is established.
V Data on 1,3-dichloropropene In combination and tank mixes are not addressed in this Guidance Document.
!5/ Data are not required In accordance with the current use patterns of this pesticide.
i7/ Data may be required unless residues in the soil dissipate to less than 50% prior to subsequent treatment.
77 Data may be required, depending on results of the confined crop studies.
8/ Special .studies: the registrant will be required to submit protocols by April 30, 1987 to monitor ground water in
order to verify that 1,3-dichloropropene including its metabolites and Impurities, Is a contaminant of ground
water supplies. The registrant(s) must take the following steps by April 30, 1987: (a) they must provide the
Agency with a map outlining sales of technical Telone II® on a county basis for the entire country, (b) they must
provide a 2 to 3 page description of the soil types, agricultural practice and climate for those geographical
areas that are typically associated with sale of the pesticide. The protocol (report and descriptions) can be
kept manageable by describing one area as a representative of several areas.
O
-------
6/1
TABLE A
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROPROPENE
Data Requirement
§158.1*10 Reentry Protection
132-1 - Foliar Dissipation
133-1 - Soil Dissipation
133-3 - Dermal Exposure
133-^ - Inhalation Exposure
§158,142 Spray Drift
Test
Substance
TEP
TEP
TEP
TEP
TEP
Use
Pattern
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
Does EPA Bibliographic
Have Data? Citation
No
Partially Ace. 259158
No
Partially Ace. 259158
3/
Must Addtl
Data be
Submitted?
No 3/
Yes I/
Yes 1/2/
Yes 1/2/
Time Frame
for
Submission
27 Months
27 Months
27 Months
_!/ For each site, registrant must propose an acceptable entry interval based upon the following:
- Tasks that require reentry Into a treated area,
- Air concentrations of 1,3-dichloropropene at the time of reentry,
- Residues of 1,3-dichloropropene in or on the soil where worker exposure to the treated soil may likely
occur.
2/ The Agency requires data on quantitative permeation anr1 breakthrough time on various materials used for protective
clothing and equipment (gloves, boots, respirator hoses, ^eces, etc.) for the formulated product(s).
If quantitative data are not available, then appropriate y- . lity studies should be conducted.
(Note the Agency received from the registrant on 7/9/86, data [Ace. 2637^1] on chemical protective clothing
materials. These data are being reviewed by the Agency. )
3/ 1,3-dichloropropene is not applied by foliar/above ground application but it is soil Injected.
LT)
-------
Bite
§158
ACUT
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Requirement
.135 Toxicology
E TJvi'i'ING:
- Acute Oral Toxicity - Rat
- Acute Dennal Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Primary Etye Irritation
- Primary Skin Irritation
- Dermal Sensitization
- Delayed
Neurotoxicity - Hen
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
Does EPA Bibliographic
Have Data? Citation
Yes 00039683, 00039686
No
No
Yes 00039676
Yes 00039676
No
No
Must Addtl Time Frame
Data be for
Submitted Submission
No
Yes 9 months
Yes 9 months
No
No ^
Yes 9 months
No I/
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding:
- Rodent, and
- No n- rodent (Dog)
- 21-Day Dermal - Rabbit
- 90-Day Dennal - Rabbit
- 90-Day Inhalation:
TGAI
TGAI
'JJ3AI
TGAI
A,B,H
A,B,H
A,B,H.
A,B,H
No
No
NO-
NO
Reserved 2_/
Reserved 2/
Yes 3/ 12 months
No ll/
Yes V
- Rat
82-5 - 90-Day Neurotoxicity:
- Hen
-Mammal
TGAI
A,B,H
No
No 5/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROFROPENE
Data Requirement Test
Substance
§158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxiclty -
2 species:
- Rodent, and TGAI
- Non-rodent (Dog) TGAI
83-2 - Oncogeniclty -
2 species:
- Rat (preferred), and TGAI
- Mouse (preferred) TGAI
83-3 - Teratogenlcity -
2 species:
- Rat TGAI
- Rabbit TGAI
83-4 - Reproduction - Rat TGAI
2-generatlon
MUTAGENICITY TESTING
Use Does EPA Bibliographic
Patterns Have Data? Citation
A,B,H No
A,B,H No
A,B,H Partially 00146469
A,B,H Partially 00146469
A,B,H Yes Ace. 0260474
A,B,H Yes Ace. 0260474
A,B,H No
Must Addtl Time Frame
Data be for
Submitted? Submission
Yes 6/ July 1988
Yes 6/
Yes 77 July 1988
Yes V July 1988
ro
in
No 87
No 8/
Yes 97 July 1987
84-2 - Gene Mutation (Ames Test) TGAI
84-2 - Structural Chromosomal
Aberration
TGAI
A, B
A, B
Yes
No
00039687, 00061059
00119179, 00120906
No
Yes 107
12 months
84-4 - Other Genotoxic Effects
TGAI
A, B
Yes
00039688
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROPROPENE
Data Re<
5158.13
SPECIAL
85-1 -
85-2 -
86-1 -
iulr< merit;
[} Toxicology - Continued
TESTING
(!erii;ral Metabolism PAI
Dermal Penetration
Domestic Animal
Test
Substance
or PAIRA
Choice
Choice
Use
Pattern
A,B
A,B
A,B
Does EPA Bibliographic
Have Data? Citation
No
No
No
Must Addtl
Data be
Submitted?
Yes
No ll/
No n/
Time Frame
for
Submission
24 months
Safety
LO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROEROFENE
§158.135 Toxicology - Continued
_!/ 1,3-diehloropropene is not an organophosphate and is not structurally related to a substance that causes delayed
neurotoxicity.
2/ Intended uses of the product may result in residues in food crops.
3/ Repeated hunan exposure may be via skin contact.
\l Not required if chronic inhalation data are submitted (studies in progress).
5_/ Neuropathy/neurotoxicity not observed in acute oral, dermal, or inhalation studies. 1,3-dichloropropene is not an
organophosphate, carbamate, or structurally related to an agent that causes neurotoxicity.
G_/ The registrant reported that chronic inhalation studies in rats and mice are in progress. Final reports are
expected in July 1988. However, it should be noted that if residues of 1,3-dichloropropene are found in food/
feel commodities, chronic feeding studies in rodent and dog may be required.
77 The registrant reportal that 2 year Inhalation/oncogenicity studies in rats and mice are in progress. Final reports
are expected in July 1988. However, it should be noted that if residues of 1,3-dichloropropene are found In
food/feed commodities, oncogeniclty feeding studies in rat and mouse may be required.
8/ If residues of 1,3-dichloropropene are found In food/feed commodities, teratology studies by oral route In the rat
and rabbit may be required.
9_/ An inhalation 2-generation reproduction study in rats is in progress. The final report is expected in July 1988.
If residues of 1,3-dichloropropene are found in food/feed commodities, a 2-generation rat study by gavage may
be required.
10/ These mutagenicity tests are required:
a. In vitro/in vivo primary hepatocyte repair for UDS testing both in vivo and in vitro exposure of cells to
1,3-dichloropropene. L
b. In vivo cytogenetics test for chromosomal aberrations using bone marrow preparations of rats, L
ll/ The guidelines and use patterns indicate that these data are not required.
-------
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROPROPENE
Data Ret
§158. 1'l1
Aquatic
'lull 'lament
'5 W! Idlif e and
Organisms
Test
Substance
Use
Pattern
Does EPA Bibliographic
Have Data? Citation
Must Addtl Time Frame
Data be for
Submitted? Submission
AVIAN AMD MAMMALIAN TESTING
71-1 -
71-2 -
71-3 -
71-4 -
71-5 -
-
Acute Avian Oral Toxlcity
Avian Subacute Dietary
Toxlcity
- Upland Game Bird, arid
- Waterfowl
Wild Mammal Toxiclty
Avian Reproduction
- Upland Game Bird, and
- Waterfowl
Simulated Field Testing
- Mammals, and
- Birds
Actual Field Testing
- Mammals, and
- Birds
TCAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
'LEP
TEP
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
Yes 00118938
Yes 00120908
Yes GS0328-002
(STEODI03)
No
No
No
No
No
No
No
No
No
No
No I/
No I/
vO
NO i/ LT>
No I/
No I/
No I/
No \]
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 1,3-DICHLOROFROFENE
Data
§158
Requirement
.145 Wildlife and
Test
Substance
Use
Pattern
Does EPA Bibliographic
Have Data? Citation
Must Addtl Time Frame
Data be for
Submitted? Submission
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1
72-2
72-3
72-4
- Freshwater Fish Toxiclty
- Warmwater Fish Species,
- Coldwater Pish Species
- Acute To'xicity to
Freshwater Invertebrates
- Acute Toxicity to
Estuarine and Marine
Organisms •
- Marine Fish
- Mollusk
- Shrimp
- Fish Early Life Stage,
and
- Aquatic Invertebrate
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
Yes 00039692
No
Yes 00039692
No
Partially 00117044
No
No
No
Wo
No
No I/
No
No I/
No I/
No I/ *f>
No !_/
No !_/
No I/
No V
No I/
Life-Cycle
72-5 - Fish - Life-Cycle
TGAI
A,B,C
No
No I/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR 1,3-D1CHLOROFROPENE
Data Requ! rtinei it
5158.1'I5 Wildlife and
Test
Substance
Use Does EPA Bibliographic
Pattern Have Data? Ci tab ion
Must Addtl Time Frame
Data be for
Submitted? Submission
Aquatic- Organisms - Continued
72-6 - Aquatic Organism
Accumulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
TGAI, PAI OR
Degradation
Product
72-7 - Simulated Field Testing
- Aquatic Organisms TEP
- Actual Field Testing
-Aquatic Organisms TCP
A,B,C
No
No
No
No
A,B,C No
A,B,C No
No I/
No I/'
No I/
No I/
No I/
- co
in
No I/
§158.1*45 Wildlife and Aquatic Qtr/inisms - Continued
I/ The requirements for addition,-)! nquatlc invertebrate testing of 1,3-dichloropropene have been waived because this
~ pesticide is a soil injected f'uiilgant; fish data and a freshwater- Invertebrate study Indicate moderate toxicity.
-------
8/1
TABLE A
GENERIC DATA REQUIREMENTS FOR 1,3-D!CHLOROPROPENE
Data Requirement
Test Use Does EPA Bib;Lographic
Substance Pattern Have Data? Citation
Must Addtl
Data be
Submitted?
Time Frame
for
Submission
§158.155 Nontarget Insect
NONTARGET INSECT' TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact toxicity
141-2 - Honey bee - toxicity
of residues on
foliage
-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
NDNTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
thru TESTING - PREDATORS
143-3 AND PARASITES
TGAI '
TEP
(Reserved) 2/
TEP
A,B,G Yes
A,B,G No
(Reserved) 37
(Reserved) 37
(Reserved) 3/
(Reserved) 3/
00028772
No
No I/
A,B,G No
No I/
LT>
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR 1,3-Di.GHLORORPROPENE
§138.135 Nontarget Insects
I/ Data Prom the acute contact study on 1,3-dichloropropene Indicate low toxlcity to bees, therefore no further
testing is required.
2/ Requirements are reserved pending development of test methodology.
37 Reserved pending Agency's decision as to whether data requirement should be established.
O
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING 1,3-DICHLOROPROPENE I/
Data Requirement
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity/Disclosure
61-2 - Description of Beginning
Materials & Manufacturing
Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Method for
Enforcement of Limits
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Pattern
All
All
All
All
All
All
Does EPA
Have Data? 2
N/A
N/A
N/A
N/A
N/A
N/A
Bibliographic
Citation
N/A
N/A
N/A
N/A
N/A
N/A
Must Addtl
Data be
Submitted?
No
Yes
Yes
Yes
Yes
Yes
Time Frame
for
Submission
6 months
6 months
12 months
12 Months
12 Months
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All : .
All
All
N/A
N/A
..•N/A
No
N/A
N/A
N/A
N/A
I, 'A
Yes
Yes
Yes
No
Yes
6 months
6 months
6 months
N/A 3/
6 months
-------
Data Requirement Test
Substance
Use Does EPA
Pattern Have Data?
Bibliographic
Ci ration
Must Addtl
Data be
Submitted?
Time Frame
for
Submission
§158.120 Product Chemistry (Continued)
Physic
(Conti
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64- 1
3al and Chemical Characteristics
Lnued)
- Density, Bulk Density,
or Specific Gravity
- pH
- Oxidizing/Reducing Action
- Flammability
- Explodabllity
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements :
- Submittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
, All
All .
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
. h'/A
i'l/A
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No V
6 months
6 months
6 months
6 months
6 months
6 months
6 months p.
6 montlis
6 months
I/ The technical product is not a registered manufacturing-use product.
2/ Not applicable. Although product chemistry data may been submitted in the past, the Agency has determined that
these'data must be resubinitted for each pesticide. • New-requirements have been introduced and previously submitted
data must be updated. Therefore bibliographic citations' for the old >iata are not applicable.
3/ Not applicable because the technical is a liquid,at roan temperature.
¥/ This compound does not require the submittal of samples.at this time.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONPAINING 1,3-DICHLOROPROPENE
Data Requirement
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat
31-2 - Acute Dermal Toxicity
- Rabbit
81-3 - Acute Inhalation Toxiclty
- Rat
81-4 - Priinary Eye Irritation
81-5 - Pritnary Skin Irritation
81-6 - Dermal Sensitlzation
Test
Substance
MP
MP
MP
MP
MP
MP
Use
Pattern
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
Does EPA Bibliographic
Have Data? Citation
Yes OOOJ9683, 00039686
No
No
Yes 00039676
Yes 00039676
No
Must Addtl
Data be
Submitted?
No
Yes
Yes
No
No
Yes
Time Frame
for
Submission
9 Months
9 Months
r^>
9 Months
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations .on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 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.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 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.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment :
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
64
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SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162,10(h){1)(ii)]
Item .78. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child'- hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 1C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category'I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
trie v,Qro POISON. [40 CFR 162 .10 ( h j (1) ( i ) ]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and in. [40 CFR 162 .10'(h) (1) ( iii ) ]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)] . •
65
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SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary .
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. . [40 CFR 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. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that .all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
66
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h) (1) (iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For-retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. , Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action, are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You m.3y delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
67
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SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to 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.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
snc--:la l:e made part of the response to this notice and submitted
for review.
68
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SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
1 r\BEL ELEMENT
PL< >duct name
Coni[ tany name
nod address
Met contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/ga 1 Ion
statement
Front panel
precaut ionary
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
whei ' dosage
given as Ibs.
ai/unit area
All products
All products
All pt 'Xlucts
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front pa>.
Front panel
Front panel
Front panel
ON LABEL
PREFERRL 1)
Center front
panel
Bottom front
panel or ond
of label text
Bottom f r< 1 ,
immediately
before or
following
Reg . No .
limed lately
following
nroduct name
L-irectly below
e main
ingredient s
statement
Alxwo signal
word
Immed i a t< • /
be lew chi ul
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. ON
^O
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.
-------
SUMMARY-7
HEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
ruiSQN (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precau t ionary
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 toxic ity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
label i ng
appears on
other than
front panel.
AJ 1 products
All prtxJucts
in Categories
I, It, and III
All products
PLACEMENT
REQUIRED
Front panel
Category I :
Front panel
unless refer-
ral statement
is used .
Others :
Grouped with
side panel
precau t ionary
statements .
Front panel
None
None
None
ON LABEL
PREFERRED
Both in close
proximity to
signal word
Front pan-_i.
for all.
Top or side
of back panel
preceding
directions
for use
Same as al >•• >ve
Same as ai • ;ve
COMMENTS
CD
h-
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.
-------
SUMMARY-8
ITEM
BC
9A
9B
10A
10B
IOC
LABEL ELEMENT
Phys Leal or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
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
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
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
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
h-.
Must be set apart and clearly distin-
guishable from fran other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
§ 162.10 Labeling requirement*.
(a) General—41) 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:
tt) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(il) 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;
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
72
-------
Environmental Protection Agency
§ 762.10
(v) The producing establishment
number as prescribed in paragraph
-------
§ 162.10
40 CFR Ch. t (7-1-35 Edition)
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 tojhumans 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 (a)(6)(ii) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual l&r.??s such as these cllk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Xame, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(i) Is false or mtgitnt/tiTTg or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to f 162.
-------
Environmental Protection Agency
§ 162.10
or endorsement of the product by the
Agency.
The text of the ingredient state-
ment must run parallel with other
text on the panel oh 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 name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(c)(6).
(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) Dstcricrzticr*. 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 ingredient*. The Adminis-
trator may require the name of any
inert ingredientts) to be listed In the
ingredient statement if he determines
that such ingredientts) may pose a
hazard to man or the environment.
75
-------
§ 162.10
40 CFR Ch. I (7-3-35 Edition)
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxicological
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:
Hazard indicators
OralU)..
Inhalation LC» ,
Dermal tOM
Eye effects
Ofc^l *Hg*** '
ToxWIy categories
1
Up 10 and including 50
mg/fcfl.
UfTSo and Induing 2
mg/Star.
Up to and incfcjcSng 200
mg/fcg.
Corrosive; come*)
opacity not reversMe
w«hin7days.
Oniirnjua
II
from SO thru 500 mg/kg_
From £ thru 2 mg/Siar —
From 200 thru 2000
Com**) opacity
raversfcta within 7
days; Irritation
persisting for 7 days.
*Ta*M^tt faritatkyi fti 72
hours.
Ill
From 500 thru 5000 mg/
kfl-
From 2. thru 20 mg/lrter_
From £000 thru 20,000-
No cornea) opacity;
Irrtuttoo rtverstote
within 7 days.
jladafata Mtatbvt at 79
hours.
rv
Greater than 5000 mg/
• hfl.-
Grwrter than 20 mg/Rter.
Greater than 20.000.
No MUlton.
Ilirl iv dMit hiHathai Bt
72 hours.
(i) Human hazard signal word—(A.)
Toxicity Category I- All pesticide prod-
ucts meeting .the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the 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 distinct! v
contrasting coio: uad the skull and
crossbones. shall appear in immediate
proximity to the word "poison."
(B) Toxicity Category IL AH pesti-
cide products meeting the criteria of
Toxidty Category n shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category 11L AH pesti-
cide products meeting the criteria of
Toxicity Category HI shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. AH pesti-
cide products meeting the criteria of
Toxidty Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal word*. Use of any
signal word(s) associated with a higher
Toxidty Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(ii) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only In cases
where ths likelihood of contact with
children curing distribution, market-
ing, storage or use is demonstrated by
the applicant to be extremely remote,
or if the nature of the pestidde is such
that it is approved for-use on infants
or stroll children, rn^y the Administra-
tor waive this requirement.
(Ill) Statement of practical treat*
m«rtt—(A) Toxicity Category L A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
Ing Into Toxidty Category I on the
t^vriff of oral, inhalation or dermal tox-
idty. The Agency may, however,
permit reasonable variations in the
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
76
-------
Environmental Protection Agency
§ 162.10
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 (hXIXiiiXA) 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 (h)(2) 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
shows the minimum type size require-
ments for the front panel warning
statements oh various sizes of labels:
Size o( label trorrt panel in square
inches
5 and under .... ._ _. _..
Above 5 to 10
Above 10 to 15 _..
Above IS to 30 _
Ounr .10
Pa
Required
sJtjoaJ
word, ««
C3pnahs
6
10
12
14
18
mts
"Keep ou(
o< reach ol
children"
6
6
8
10
12
(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-
cating 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.
Tcsscrty
category
Precautionary sia?«r«:u'j. Dy i-;adty category
Oral, inhalation, or dermal toxicity
Skin and eye local effects
ifl.
IV.
Fatal (poisonous) V swallowed (inhaled or absorbed
through •kin]. Do not breath* vapor (dust or spray
mist]. Do not get h sysc. cr. sJ-Jn. or on ctotning
(Front panel statement o( practical treatment re-
quired.].
May be total V swallowed (inhaled or absorbed
through the aUn]. Do not breathe vapor* (dust or
•pray mist]. Do not get in eye*, en skin, or on
clothing. (Appropriate Srst aid statements required.].
Ham** H •waiowed (inhaled or absorbed trough tha
•WrO. Avoid breathing vapors (dust or spray mist].
Avoid contact with skit (eyea or dotrtng]. (Appro-
priate first aid statement required.].
(No precautionary statements required.]
Corrosive, causes eye and skin damage (or skin
irritation]. Do not get ki ayes, on skin, or on
clothing. Wee/ goggles 3* face shield and rubber
gloves whan handing. HanntU or «atal If swallowed.
(Appropriate first aid statement required.]
Cause* eye (and skin] Irritation. Do not get In eyes,
on akin, or on clothing. Harmful tf swsMowad. IA$K
propriate first aid statement required.]
Avoid contact wWi aUn, eyea or clothing, to case o(
contact InvntdaWftvty fcMh t^n or skin *vW> ptonty of
Get imdfcaJ attention tf Walton
(No praeauaonary state«nents required.]
(11) 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-
77
-------
§ 162.10
40 CFR Ch. I (7-1-85 Edition)
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 LC»« of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LD» of 100
mg/kg or less, or a subacute dietary
LC» of 500 ppm or less, the statement
"This Pesticicle is_ Toxic to Wildlife" is
required. :
» nww BO* F , .., , ,
• • •••"•' ,-:>•
-------
Environmental Protection Agency
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(1) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es;
(J) The product will not come into
the hands of the general public except
after Incorporatipnjnto finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
U) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) 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:
(i) 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;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
(4) 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."
-------
§ 162.11
40 CFR Ch. I (7-S-35 Edition)
(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.
(P) 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) (1) 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 differen-
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted usets) 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 § 162.10(j)(2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classifted general ~ha?J be la-
beled with the exi.,-1 s^ras "General
Classification" immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state*
ment under the statutory definitions
of misbranding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use
-------
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
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.
C. All Other Pressurized
Containers
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat,_sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do -not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
II
Non-Pressurized Containers
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
L:-'.t rerne 1 y f 1 c^ma b 1 -_? ,
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.
81
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due ,to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
^.rcc^r open in.? and closing procedures (particularly for
opened containers), and measures to minimize exposur-.
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.
82
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
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 that are Acute Hazardous
Wastes (see list in this Appendix) or are assigned to Toxicity Category
I on the basis of oral or dermal toxicity, skin or eye irritation potenti:
or Toxicity Category I or II on the basis of acute inhalation toxicity
must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The -labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
(see list in this Appendix) or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide disposa
statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
Bastes cannot he disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products 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. All other products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
( non-aerosol)
Plastic -containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
}_/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
84
-------
OMB Approval No. 2000-0462 (Expires.12-31-83}
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(6)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the-.follbwing data requirements:
LJ 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
EH 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
85
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-82)
-------
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
§158.120
PRODUCT
CHEMISTRY
61-1
Identity of
ingredients
61-2
Statement of
composition
61-3
Discussion of
formation of
ingredients
62-1
Preliminary
analysis
62-2
Certification of
limits
62-3
Analytical methods
for enforcement
limits
63-2
Color
63-3
Physical state
63-5
Melting point
63-6
Boiling point
63-7
Density, bulk-
density, or
specific gravity
63-8
Solubility
63-9
Vapor pressure
63-10
Dissociation
constant
63-11
63-12
Octanol/water
partition
coefficient
PH
86
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135. ..
TOXICOLOGY
81-1 '
81-2
81-3
81-4
81-5
81-6
•
Name of Test
Stabilit^
Ox id i z i ng/ reduc i ng
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute
toxicit rat
Acute c m?1.
toxicit^ , rabbit
Acute inhalation,
toxicity, rat
Primary eye
:.rrit=tion, r?±bit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
( check
below)
I am complying
data requireme
Citing MRID
Number or
EPA Accession
Number
-
1 with
;nts by
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
87
-------
OMB Accmvsl No. 20CO-Q468 f Expires: 12-31-831
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certify ALL four items) FOR DEVELOPMENT OF DATA
1. 1 am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
ACTIVE 1NGPSDIENT
EPA COMPANY NUMBER
(This firm or group of firms 15 referrsg TO c-eiov. as "rny firm".)
2. My firm is willing to develop and submit the data as required by thai Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to bf
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was mad(
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) abovi
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inforrt
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B) (This statemen
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
'ED
SIGNATURE
DATE
EPA Form 8580-6 (10-82)
-------
FORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Name
Applicant's Name-and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s): •
(2) Each active ingredient listed in paragraph (1) is present solely
as the result of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer. .
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
riane, the source of the active ingredient(s) listed in paragraph (1).
OR'.
(B) The Confidential Statement of Formula dated on file with
the EPA is complete, current and accurate and contains the information
required on the current CSF Fonr. No. 2570-4. The registered source(s)
of the active ingre
-------
BIBGUIDE-1
GUIDE TO USE OP THIS BIBLIOGRAPHY
1,3-DICHLOROPROPENE
1. CONTENT OP BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OP ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically -larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
.citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OP ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not; related 1:0 the six-digit ''Accession Number"
which has been used to identify'volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation.containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
90
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last"resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
'!) Submission Date. The date of the earliest known
submission appears Immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
r-rglst rat Ion number, exr-rirrental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter, •
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number Is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123^56, the
first study would be 123^56-A; the second, 123*156-
B; the 26th, 123W-Z; and the 27th, 123^56-AA.
91
-------
OFFICE OP PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 1,3-Dichloropropene Standard
MRID CITATION
00028772 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1973) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. Rev. By Univ. of California—Riverside, Dept.
of Entomology. Riverside, Calif.: UC, Agricultural Extension
Service. (Also in unpublished submission received Apr 2, 1980
under 464-556; submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:242149-Z)
00030385 Glas, R.D. (1979) Determination of Residues of Cis- and Trans 1,3-
Dichloropropene in Plant Materials: ACR 79.15. Method dated Nov
30, 1979- (Unpublished study received Peb 7, 1980 under 464-
511; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
241761-B)
00033255 McKinney, W.J.; Wendt, M.B.; Abbott, R.; et al. (1978) Residues in
Sugarbeets: TIR-24-355-76. (Unpublished study Including TIR-
24-355-76-B, received Jun 25, 1980 under 464-511; prepared by
• Shell Development Co., submitted by Dow Chemical U.S.A., Mid-
'. land, Mich.; CDL:242726-A)
00033256 McKinney., W.J.; Wendt, M.B.; Fries, P.A.; et al. (1978) Residues
in Cabbage: TIR-24-160-78-A. (Unpublished study including TIR-
24-195-78B and TIR-24-195-78, received Jun 25, 1980 under 464-
511; prepared by Shell Development Co., submitted by Dow Chemi-
cal U.S.A., Midland, Mich.; CDL:242726-B)
00033257 McKinney, W.J.; Wendt, M.B. (1978) Residues in Potatoes: TIR-24-
172-7£-'.. (Unpublished study including TIR-24-172-78-B, r-r-
ceived Jun 25, 1980 under 464-511; prepared by Shell Development
Co., submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
242726-C)
00033258 McKinney, W.J.; Pries, P.A.; Wendt, M.B.; et al. (1978) Residues
in Cauliflower: TIR-24-180-78. (Unpublished study Including
TIR-24-180-78-B, received Jun 25, 1980 under 464-511; prepared
by Shell Development Co., submitted by Dow Chemical U.S.A., Mid-
land, Mich.; CDL:242726-D)
00033259 McKinney, W.J.; Fries, F.A.; Wendt, M.B.; et al. (1978) Residues
in Lettuce: TIR-24-191-78A. (Unpublished study including TIR-
24-191-78-B, TIR-24-192-78A,and TIR-24-192-78-B, received Jun
25, 1980 under 464-511; prepared by Shell Development Co., sub-
mitted by Dow Chemical U.S.A., Midland, Mich.; CDL:242726-E)
92
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OFFICE OP PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the l,3"-Dichloroproprene Standard
MRID CITATION
00033260 McKinney, W.J.; Pries, P.A.; Bierman, B.; et al. (1979) Residues
in Watermelon: TIR-24-227-78B. (Unpublished study including
TIR-24-227-78, TIR-24-244-78-B and TIR-24-244-78, received Jun
25, 1980 under 464-511; prepared by Shell Development Co. and
others, submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
242726-P)
00033261 McKinney, w.J.; Brown, L.J.; Doern, B.L.; et al. (1979) Residues
in Various Crops: TIR-24-642-78. (Unpublished study including
TIR-24-614-79, received Jun 25, 1980 under 464-511; prepared by
Shell Development Co., submitted by Dow Chemical U.S.A., Mid-
land, Mich.; CDL:242726-G)
00033262 Dutson, N.J.; Seager, S.V.; Wallace, E.G.; et al. (1977) Residues
of the Major Components of D-D and Primary Metabolites in Let-
tuce from Germany: Group Research Report BLGR.0024.77. (Unpub-
lished study received Jun 25, 1980 under 464-511; prepared by
Shell Research, Ltd., submitted by Dow Chemical U.S.A., Midland,
... . • Mich.; .CDL-242726-H)
00033263-Bosio, P.;~ Jranier, R. (1977) Residues of D-D in Potatoes from
France- 76/77 Trials: Group Research Report BEGR.0086.77.
(Unpubl ned study received Jun 25, 1980 under 464-511; prepared
by She! Chlmie, submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:242726-I)
00033264 Sherren, A.J.; Murray, S.M.; Wallace, E.G.; et al. (1978) Residues
of •;":— I-.ajor Components of I--D ~x:;a Primary Ifetabclites in Pine-
apples from South Africa: Group Research Report BLGR.0071.78.
(Unpublished study received Jun 25, 1980 under 464-511; prepared
by Shell Research, Ltd., submitted by Dow Chemical U.S.A., Mid-
land, Mich.; CDL:242726-J)
00039676 Dow Chemical U.S.A. (1978?) Summary of Human Safety Data. Summary
of studies 099515-1 and 099515-J. (Unpublished study received
Jul 22, 1980 under 464-EX-63; CDL:099515-C)
00039683 Toyoshima, S.; Sato, R.; Sato, S. (1978) The Acute Toxicity Test on
Telone II in Mice. (Unpublished study received Jul 22, 1980 un-
der 464-EX-63; prepared by Kelo Univ., Drug Chemistry Institute,
Chemotherapy Div. and Japan Experimental Medical Research Insti-
tute Co., Ltd., submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:099515-J)
93
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OFFICE OP PESTICIDE PROGRAMS .
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 1,3-Dlchloroproprene Standard
MRID CITATION
00039686 Torkelson, T.R.; Oyen, P. (1977) The toxicity of 1,3-Dichloropro-
pene as determined by repeated exposure of laboratory animals.
American Industrial Hygiene Association Journal 38(?/May):217-
223. (Also in unpublished submission received Jul 22, 1980
under 464-EX-63; submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:099515-M)
00039687 De Lorenzo, P.; Degl'Innocentl, S.; Ruocco, A.; et al. (1977) Muta-
genicity of pesticides containing 1,3-Dichloropropene. Cancer
Research 37(?/Jun):1915-1917. (Also in unpublished submission
received Jul 22, 1980 under 464-EX-63; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:099515~0)
00039688 Sudo, S.; Nakazawa, M.; Nakazono, M.; et al. (1978) The Mutageni-
city Test on 1,3-Dichloropropene In Bacteria Test System: Proj-
ect No. NRI-78-2819. (Unpublished study received Jul 22, 1980
under 464-EX-63; prepared by Nomura Sogo Research Institute,
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:099515~P)
00039692- Bentley, R.E. (1975) Acute Toxicity of M-3993 to Bluegill
(Lepomis macrochirus) and Rainbow Trout (Salmo gairdneri).
(Unpublished study received Jul 22, 1980 under 464EX-63;
prepared by Bionomics, EG&G, submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:099515-T)
00039693 Dow Chemical U.S.A. (19??) Summary of Residue Analyses of 1,3-Di-
chloropropenes in Crops Treated Post-plant with Telone II. (Un-
published study received Jul 22, 1980 under 464-EX-63; CDL:
099515^)
0003969^ Glas, R.D. (1980) Determination of Resudies [sic] of Cis- and :
Trans- 1,3-Dichloropropene in Fruit: ACR 80.9. Method dated Jul
9, 1980. (Unpublished study received Jul 22, 1980 under 464-EX-
63; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
099515-X)
00039695 Glas, R.D. (1980) Determination of Residues of Cis- and Trans-
Chloroallyl Alcohols in Fruit by Gas Chromatography Using and E-
lectrolytic Conductivity Detector: ACR 80.10. Method dated Jul
9, 1980. (Unpublished study received Jul 22, 1980 under 464-EX-
63; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
099515-Y)
94
-------
OFFICE OP PESTICIDE' PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 1,3-Dichloropropene Standard
MRID CITATION
00039696 Lembright, H.W.; Hart, W.; Rough, D. (1980) Residues of 1,3-Di-
chloropropenes and Chloroallyl Alcohols in Green Almonds Grown
in Soil Fumigated with Telone II Soil Fumigant. (Unpublished
study received Jul 22, 1980 under 464-EX-63; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:099515~Z) .
00040721 Bauriedel, W.R.; Craig, L.F. (1973) A Study of the Residue Present
in Sugar Beets Grown in Soil Treated with 14C-Labeled Cis- and
Trans-l,3-Dichloropropene. (Unpublished study received Jul
22, 1980 under 464-EX-63; submitted by Dow Chemical U.S.A., Mid-
land, Mich.; CDL:099516-L)
00040722 Berry, D.L. (1973) Absorption, Translocation and Metabolism of 1,3-
Dichloropropene in Selected Plants. Doctoral dissertation, Utah
State Univ. (Unpublished study received Jul 22, 1980 under 464-
EX-64; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
. . 099516-M)
00061059 Brooks, T.M.; Dean, B.J.; Wright, A.S. et al. (1978) Toxicity Stud-
••.-' ies with Dlchloropropenes: Mutation Studies with 1,3-D and
cis-1,3-Dichloropropene and the Influence of Glutathione on
the Mutagenicity of cis-l,3-Dichloropropene in Salmonella
typhimurium: Group Research Report TLGR.0081.78. (Unpublished
study received Sep 5, 1978 under 201-119; prepared by Shell
Research, Ltd., England, submitted by Shell Chemical Co.,
Washington, D.C.; CDL:235251-F)
00109291 Shell Development Co. (1981) Residue Determination of the Z and E
Isomers of 3-chloroallyl Alcohol (CAA) In Agricultural Com-
modities, Soils, and Water: Capillary GLC/Hall Electrolytic
Conductivity Detector Method: MMS-R-506-2. (Unpublished study
received Jan 15, 1982 under 201-253; CDL:246671-A)
00109420 Shell Development Co. (1981) Residue Determination of 1,2-di-
chloropropane and the Z and E Isomers of 1,3-dichloropropene
in Agricultural Commodities, Soil and Water: Capillary GLC/Hall
Electrolytic Conductivity Detector Method: MMS-R-505-2. (Un-
published study received Jan 15, 1982 under 201-253; CDL:
246672-A)
00109672 Shell Chemical Co. (1978) D-D Crop Residue and Analytic Methods:
Volume III. (Compilation; unpublished study received Aug 30,
1978 under 201-119; CDL:235253-A)
95
-------
OFFICE OP PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 1,3-Dichloropropene Standard
MRID CITATION
00115213 Dow Chemical U.S.A. (1982) A Data Sheet Giving the Chemical and
Physical Properties of the Chemical. A Complete Statement of the
Names and Percentages by Weight of Each Active and Inert In-
gredient in the Formulation to Be Shipped. (Compilation; un-
published study received Sep 22, 1982 under 464-EX-63; CDL:
248406-A)
00115214 Dow Chemical U.S.A. (1982) Residue Data, Where Pertinent, on (a)
Food or Feed Commodities; (b) Non-food Crops Such as Tobacco;
and (c) Foliage or Other Sites Which May Relate to Worker Hazard
or Adverse Effects on the Envirorment. Include a Description of
the Analytical Method(s) Used and a Summary of the Data. (Com-
pilation; unpublished study received Sep 22, 1982 under 464-EX-
63; CDL:248406-B)
00117044 LeBlanc, G. (1980) Acute toxicity of priority pollutants to water
flea (Daphnia magna). Bull. Envirorm. Contam. Toxicol. 24:684-
691. (Also in unpublished submission received Sep 22, 1982
under 464-EX-63; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:248415-F)
00117045 Dow Chemical U.S.A. (1982) Telone II Chemistry Data. (Compila-
tion; unpublished study received Sep 22, 1982 under 464-EX-63;
CDL:248416-A)
00118938 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Acute Oral LD50—
Bobwhlte Quail: Telone II Soil Fumlgant: Project No. 103-207.
Final rept. (Unpublished study received Sep 22, 1982 under
464-EX-63; prepared by Wildlife International Ltd., submitted
by Dow Chemical U.S.A., Midland, MI; CDL:248415-C)
00119178 Dow Chemical U.S.A. (1977) Telone II Soil Fumigant: Product Chem-
istry. (Compilation; unpublished study received Mar 23, 1977
under 464-511; CDL:228769-A)
00119179 De Lorenzo, P.; Degl'Innocent!, S.; Ruocco, A.; et al. (1975) Muta-
genicity of Pesticides Containing 1,3-Dichloropropene. (Unpub-
lished study received Jun 15, 1977 under unknown admin, no.;
prepared by Univ. of Naples, Italy, submitted by Dow Chemical
U.S.A., Midland, MI; CDL:230634-B)
96
-------
OFFICE OP PESTICIDE PROGRAMS
' REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 1,3-Dichloropropene Standard
MRID CITATION
00120906 Flessel, P. (1977) Letter sent to J. Wesolowski dated Apr 8, 1977:
Mutagen testing program, mutagenic activity of Telone II in the
Ames salmonella assay. (Unpublished study received Jun 15, 1977
under unknown admin, no.; prepared by California, Dept. of
Health, submitted by Dow Chemical U.S.A., Midland, MI; CDL:
230634-A)
00120908 Fink, R. (1975) Eight-day Dietary LC50~Mallard Ducks: M 3993:
Project No. 103-150. Final rept. (Unpublished study received
Oct 24, 1978 under 464-511; prepared by Truslow Farms, Inc.,
submitted by Dow Chemical U.S.A., Midland, MI; CDL:235368-B)
00146469 US of Public Health Service (1985) Toxicology and Carcinogenesis
Studies of Telone II (Technical-grade 1,3-Dichloropropene
[CAS No. 542-75-6] Containing 1.0% Epichlorohydrin as a Stabil-
izer) in F344/N Rats and B6C3F1 Mice (Gavage Studies): NIH Pub-
lication No. 85-2525. US Government Printing Office. 153 p.
97
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EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE
TABLE OF CONTENTS
Site Name ?a_gs
TERRESTRIAL FOOD CROP 3
(Agricultural Crops) 3
Caneberries 6
Citrus Fruits __ 6
Citrus Fruits 6
Deciduous Fruit Trees 6
Field Crops 7
Mint 8
Nut Trees 6
Peach 9
Pineapple 9
Potato (white) 9
Small Fruits 7
Strawberry 10
Sugar Beets 10
Vegetables 7
Vine Fruits 6
TERRESTRIAL NON-FOOD CROP 11
(Agricultural Crops) 11
Tobacco 11
(Ornamental Plants and Forest Trees) 11
Forest Trees 11
Ornamental Flowering Plants 12
Ornamental Grasses 12
Ornamental Plants 12
Ornamental Plants (deep rooted) 11
Ornamental and/or Shade Trees 11
Ornamental Turf 12
Issued: 3-06-84 11-029001-i
Provisional Update: 8-29-86 n o
70
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EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE*
TYPE PESTICIDE; Nematicide, Insecticide, Fungicide, Herbicide
FORMULATIONS; RTU (9.5 Ib/gal or 942)
GENERAL WARNINGS AND LIMITATIONSt RESTRICTED DSE PESTICIDE. Apply only
as a preplant soil fumigation treatment. Telone II is corrosive under
certain conditions - flush all applicators with fuel oil or kerosene imme-
diately after use. Do not use water. Do not use containers, pumoj, or
other transfer equipment made of aluminum, magnesium or their alloys, as
under certain conditions Telone II may be severely corrosive to such
metals.
Fumigation may temporarily raise the level of ammonia nitrogen and soluble
salts in the soil. T~..is is most likely to occur when heavy rates of fer-
tilizer and fumigant are applied to soils that are either cold, wet, acid,
or high in organic matter. To avoid injury to plant roots, fertilize as
indicated by soil tests made after fumigation. To avoid ammonia injury
or nitrate starvation, or both, to crops on high organic soils do not use
fertilizers containing ammonium salts and use only fertilizers containing
nitrates, until after the crop is well established and the soil tempera-
ture is above 65 F (18.3 C).
Certain crops including cotton, sugarcane, and pineapple are tolerant to
ammonia and the above rule does not apply to them. When using high rates
of Telone II as required by certain state nursery regulations, liming of
.highly:a,cid .soils be:" v . fumigation may stimulate nitrification and reduce
the possibility of r- lia toxicity. Certain nursery crops such as citrus
seedings, Cornus sp. Jrataegus sp., spruce, and vegetable crops such as
cauliflower have she . evidence of phosphorous deficiency following fumi-
gation. To avoid tl s possible effect, it is suggested that additional
phosphate fertilizer be used on soils where experience indicates a defi-
ciency may occur.
Precautionary Statements: DANGER. Corrosive, causes irreversible eye
damage. May be fatal if inhaled, absorbed through skin, or swallowed.
Do not get in eyes, on skin or on clothing. Wear chemical worker goggles,
face shield or safety glasses. Wash thoroughly with soap and water after
handling, and before eating and smoking.
Required clothing and equipment for mixing/loading and applying 1,3-
dichloropropene: One-piece coveralls which have long sleeves and long
pants constructed of laminated fabric as specified in the USDA/EPA Guide
for Commercial Applicators; liquid-proof hat such as a plastic hard hat
with a plastic sweat band; heavy-duty liquid proof (neoprene/synthetic)
work gloves and boots. Any article worn while handling 1,3-dichloropro-
pene must be washed before reusing. Immediately remove all clothing which
has been drenched or has otherwise absorbed 1,3-dichloropropene from any
spill. Dispose contaminated clothing in a sanitary landfill, by incinera-
tion, or if allowed by state and local authorities by burning. If burned,
stay out of smoke.
*Telone II
Issued: 3-06-84 11-029001-1
Provisional Update: 8-29-86
99
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EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE
GENERAL WARNINGS AND LIMITATIONS (continued)
NIOSH- or MESA-approved respiratory protection should be worn when Telone
II liquid soil fumigant is exposed to the atmosphere or when conducting
operations which vent to the atmosphere. A NIOSH- or MESA-approved
half-face respirator with chemical worker's goggles or full-face respira-
tors shall be used during small spills, repairs, calibrations, transfers,
sampling and when working in poorly ventilated areas. When in use_cannis-
ters or cartridges shall be replaced daily or sooner if specified by manu-
facturer or at first sign of odor breakthrough, whichever comes first.
NIOSH-approved cartridges, such as a Welsh 7400-IL, will be adequate for
short-term situations such as listed above.
Where very high concentrations of vapors might be expected (such as large
spills in poorly ventilated areas) a self-contained or air-supplied res-
pirator should be used.
Field Reentry Statement: Workers entering the treated area for 72 hours
after application of 1,3-dichloropropene must wear protective clothing.
Definition of Terms;
a.i. - active ingredient
Issued: 3-06-84 II-029001-2
Provisional Update: 8-29-86
-------
and Pest
EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE
Dosages and Tolerance, Use, Limitation.;
Formulation(s)
TERRESTRIAL FOOD CROP
^Agricultural Crops)
General Warnings and Limitations; Apply as a preplant soil treatment
to control plant parasite nematodes [root-knot, meadow (lesion), citrus,
cyst formers (golden, sugar beet, soybean), burrowing, ring, spiral,
sting, pin, stubby root, stylet, dagger], wlreworms, and symphylans.
Apply to land to be planted with the following crops:
Vegetable
asparagus
beans
beets
blackeyed peas
broccoli
brussels sprouts
cabbage
cantaloupe
carrots
cauliflower
celery
collards
Field Crops:
alfalfa
barley
birdsfoot trefoil
buck-wheat
clover
corn
cotton
com
cowpeas
cucumbers
egg plant
endive
garlic
horseradish
kale
kohlrabi
leeks
lettuce
melons
flax
grasses
hops
lespedeza
millet
milo
mint
mustard greens
okra
onions
parsnips
peas
peppers
pimentoes
potatoes
pumpkins
radishes
rutabagas
salsify
oats
pasture grass
peanuts
popcorn
rice
rye
safflower
shallots
spinach
squash
(summer)
squash
(winter)
sweet potatoes
swiss chard
tomatoes
turnips
watermelons
sorghum
soybeans
sugar beets
sugarcane
tobacco
vetch
wheat
Citrus Fruit Tree Planting Sites:
grapefruit lemons
kumquats limes
oranges
tangerines
Deciduous Fruit and Nut Tree Planting Sites;
almonds dates olives
apples figs peaches
apricots filberts pears
cashews nuts hazelnuts pecans
cherries hickory nuts persimmons
chestnuts nectarines pineapple
Bush and Vine Planting Sites:
blackberries currants
blueberries dewberries
boysenberries gooseberries
cranberries grapes
huckleberries
loganberries
raspberries
strawberries
Issued: 3-06-84
Provisional Update: 8-29-86
II-029001-3
101
tangelos
plums
pomegranates
prunes
quince
walnuts
youngberries
-------
EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
General Warnings and Limitations (continued)
Nursery Crops; including floral plants, ornamentals, shrubs and
bushes, forest, shade, fruit and nut trees and vine and bramble fruits
of all types.
APPLICATION DIRECTIONS:
When to Treat; Apply Telone II either in the spring, or fall, whenever
soil type and conditions permit. For best results with annual crops,
treat the soil each year. In northern states, late summer, or early
fall treatment (before October 15) is best for land to be planted to
early spring crops, especially transplanted crops such as celery, toma-
toes, and nursery and orchard stock. Early fall treatment permits
planting a fall cover crop. Note: Treat muck soils only in the early
fall and plant as late as possible in the spring; treat fine textured
(clay) soils only when they are near or at the wilting point. Do not
use Telone II to treat any type of soil when it is cold and/or wet.
Soil Preparations; Telone II gives best results when conditions permit
rapid diffusion of the fumigant through the soil and the soil surface
can be sealed to prevent excessive fumigant loss during the exposure
period. The soil should be in good seed bed condition, free of clods
and undecomposed plant material, moisture at about one-half of field
capacity, and temperature between 40 and 80 F (4.4 and 26.7 C) at the
depth of "injection. If undecomposed plant debris is present, it should
be plowed down and allowed to decompose before applying Telone II. Til-
lage deeper than 12 inches is necessary for good fumigant penetration
in soils where a hard or "plow" pan occurs at plow depth. Where deep
tillage is used, the tillage equipment may often be modified to simulta-
neously apply the fumigant and thus avoid going over the field twice.
Application: Telone II may be applied either as a broadcast (overall)
or row treatment, using suitable application equipment that will ensure
placement of the fumigant at least 6 to 8 inches below the final soil
surface. For broadcast application, use either plowsole or chisel
equipment with the chisels spaced 12 inches apart. When the fumigant
is injected at a depth of 12 inches or more (deep tillage), the chisel
spacing may be up to twice the application depth but should not exceed
30 inches. Application may be made in the same direction or at an angle
to the direction of the planting row, whichever is most convenient. For
row application, use chisel equipment with 1 chisel per row or 2 chisels
spaced 12 inches apart to treat only the soil where the crop is to be
planted. When 1 chisel per row is used, adjust the fumigant flow rate
to distribute about 1.33 times more fumigant per chisel than is recom-
mended for overall application. When 2 chisels are used per row, apply
at the same flow rate per chisel as for broadcast. In both cases, the
amount of fumigant required per acre will decrease as the distance be-
tween rows is increased and vice versa. At time of planting, avoid
placing the seed row directly over the furrow left by the applicator
chisel. When a single chisel is used per row, place the seed 3 to 4
inches to 1 side of the chisel furrow; when 2 chisels are used, plant
in the center of the area between the chisel furrows.
Issued: 3-06-84 II-029001-4
Provisional Update: 8-29-86 i « ^
-------
EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
General Warnings and Limitations (continued)
Sealing; Immediately after application, compact the soil surface to
prevent excessive fumlgant loss. After chisel application, use a rol-
ler, cultipacker, or similar sealing device. After plow-side applica-
tion, disk the land, then compact it by floating or rolling. Sealing
after row application can be accomplished by the tractor wheel, by list-
ing, or by bedding so that the fumigant will be 12 to 14 inches below
the top of the bed. When fumigating listed rows, seal in the fumigant
with ring rollers, press sealers, ..or by re-listing.
Exposure Period; After application and sealing, leave the soil undis-
turbed for 7 to 14 days. A longer exposure period will be required if
the soil becomes excessively cold or wet during the exposure period.
Aeration and Preparation of Soil Before Planting: At the end of the ex-
posure period allow the soil to aerate completely before planting the
crop. Aeration is usually complete when the odor of Telone II is no
longer evident. Under optimum soil and weather conditions, allow 1 week
of aeration time for each 10 gallons of Telone II applied per acre.
When Telone II is used for treating deep-rooted tree and shrub planting
sites, a 3 to 6 months aeration period should be allowed. To hasten
aeration, especially if heavy rains or low temperatures occur during the
exposure period, work the soil to the depth of the treatment zone. Af-
ter row treatment use a knife-like chisel in the bed without turning the
soil, -thus reducing possible recontamination of the treated soil. To
hasten aeration after overall treatment, plow or deep cultivate to the
depth of the treatment zone. This is especially desirable in northern
states after fall fumigation of muck soils.
Note: To avoid reinfestation of treated soil do not use irrigation
water, transplants, tools, seed pieces or crop remains that could carry
soilborne pests from infested land^ Clean equipment carefully before
using.
Note; Dosages are given in pounds active ingredient.
Issued: 3-06-84 II-029001-5
103
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Site and Pest
/01001AA
/02000AA
/28038AA
/03000AA
/28043AA
/30000AA
/35000AA
/32000AA
'26003AA
'A3AAAA
IJDAAAA
INAVAAA
/02000AA
NEJBCBA
NABAAAA
IJDAAAA
INAVAAA
EPA Compendium of Acceptable Uses
1,3-DICKLOROPROPENE
Dosages and Tolerance, Use, Limitations
Fommlation( s)
Caneberries
Citrus Fruits
Deciduous Fruit Trees
Nut Trees
Vine Fruits
Meraatodes
Symphylans
Wireworms
N.F.
Preplant soil treatment through
313.5 pounds per acre for sandy
soil, 456.0 pounds per acre for
sandy loam, 712.5 pounds per_acre
for silt loam, and 969.0 pounds per
acre for clay loam.
Preplant soil treatment. Broadcast.
Apply to nursery and field planting
sites.
Pounds a.i. (94% RTU) per acre to penetrate vari-
ous depths
Mineral soils
sand
sandy loam
silt loam
clay loam
3 ft
142.5
256.5
399.0
513.0
4 ft
199.5
285.0
434.5
655.5
5 ft
256.5
342.0
598.5
798.0
6 ft
313.5
456.0
712.5
969.0
1.94 Ib/hole
(94% RTU)
Citrus Fruits
Burrowing nematode
Nematodes
Symphylans
Wireworms
Preplant soil treatment to tree
planting sites prepared by backhoe-
ing. Apply by pouring into the hole
during backfilling. For best re-
sults prepare and treat sites in the
fall and plant in the spring.
Refer to Cit—cs Fruits for additional information.
N.F.
Preplant soil treatment through
342.0 pounds per acre in FL.
Broadcast: Use limited to FL.
342.0 Ib/A Preplant soil treatment. Apply as
or a broadcast treatment on mineral
7.87 lb/1,000 soils. For burrowing nematode, in-
linear ft of ject on 18-inch centers, 12 inches
deep. Keep area free of plants that
are susceptible to burrowing nema-
todes for 2 years before replanting
to citrus.
row/chisel
(94% RTU)
Also refer to Caneberries cluster for additional
information.
Issued: 3-06-84
Provisional Update: 8-29-86
11-029001-6
104
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Site and Pest
EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE
Dosages and Tolerance, Use, Llaitations
Formulation(s)
{049AA
JOOOAA
J024AA
'I003AA
J3011AA
J2000AA
J008AA
Deciduous Fruit Trees
Field Crops
Small Fruits
Vegetables
JFBAAA
JBAAAA
SAVAAA
Cyst nematodes
Nematodes
Symphylans
Wireworms
Broadcast:
85.5-171.0
Ib/A
or
1.93-3.93
lb/1,000
linear ft
of row/
chisel
•[mineral]
or
171.0-342.0
Ib/A
or
3.93-7.87
Ib/1,000
linear ft
of row/
chisel
[muck or
peat]
or
Row (42 inch
spacing):
42.75-57.0
Ib/A
or
3.41-4.6
lb/1,000
linear ft
of row/
chisel
[mineral]
(94% RTU)
or
See Caneberries cluster.
N.F.
Preplant soil treatment through
331.2 pounds per acre in muok or
peat soils or 165.8 pounds per acre
in mineral soils using broadcast
treatment; or, 110.4 pounds per acre
in muck or peat soils or 55.2 pounds
per acre using row treatment on 42
inch spacing.
Row treatment is not recommended for
potatoes in irrigated areas of west-
ern and northwestern states.
Preplant soil treatment for shallow
rooted plants. Apply the higher
rates in heavier soil. For symphy-
lans, use only the broadcast treat-
ment at a minimum of 171.0 pounds
per acre, and apply during late sum-
mer or early fall when the soil is
warm. For wlreworms, apply the
higher rates recommended for nema-
todes in broadcast treatments. For
broadcast treatment of cyst-forming
nematodes in mineral soils, apply
171.0 pounds per acre; for other
nematodes, apply up to 142.5 pounds
per acre. For broadcast treatment
of muck soils containing less than
30 percent organic matter, apply
171.0 pounds per acre; otherwise,
apply a minimum of 228.0 pounds per
acre.
Issued: 3-06-84
Provisional Update: 8-29-86
II-029001-7
105
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Site and Pest
EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE
Dosages and Tolerance, Use, Limitations
Formulation(s)
28012AA
'GATVAK
Field Crops cluster (continued)
85.5-114.0
Ib/A
or
6.9-9.13
lb/1,000
linear ft
of row/
chisel
[muck or
peat]
(94% RTU)
Mint
Verticillium wilt
N.F.
Preplant soil treatment through
560.5 pounds per acre (broadcast).
Nut Trees
Broadcast: Use limited to northwestern states.
560.5 Ib/A Preplant soil treatment. Apply to
or aid in the reduction of the effects
12.84 lb/ of Verticillium wilt in disease in-
1,000 linear fested soil. Apply in the spring
ft of row/ or preferably in the fall. After
chisel treatment allow at least 7 to 8
(94% RTU) weeks or until the odor of the fumi-
gant has left the soil before plant-
ing. Consult a State Cooperative
Agricultural Extension Service for
the use of other practices such as
flaming the stubble, weed control,
and cultural practices when using
the active ingredient as an aid to
reducing damage caused by Verticil-
lium wilt.
Refer to Field Crops cluster for additional in-
formation.
See Caneberries cluster.
Issued: 3-06-84
Provisional Update: 8-29-86
II-029001-8
106
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Site and Pest
EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE
Dosages and Tolerance, Use,
Formulation(s)
05004AA Peach
DZAPDZ Bacterial canker
(Pseudomonas)
Broadcast:
228.0-342.0
Ib/A
or
5.27-7.87
Ib/I,000
linear ft
of row/
chisel
(94% RTU)
N.F.
Preplant soil treatment through
342.0 pounds per acre (broadcast).
Preplant soil treatment. Apply as
an aid in the control of bacterial
canker and decline in light (sandy)
soils. Apply preferably in the fall
vhen the soil is warm (50 to 85 F
(10.0 to 29.4 C) at 6-inch depth)
and moist. Inject at a depth of 10
to 12 inches with chisels mounted
on 12 inch centers.
Refer to Caneberries cluster, Deciduous Fruit
Trees for additional information.
/06013AA
NABAAAA
TJDAAAA
INAVAAA
/14013AA
Pineapple
Nematodes
Symphylans
Wireworms
Potato
Row:
228.0-342.0
Ib/A
[mineral]
(94% RTU)
N.F.
Preplant soil treatment through
342.0 pounds per acre (broadcast).
Preplant soil treatment. For
Hawaiian pineapple, apply at time
of or just before planting.
N.F.
Preplant soil treatment through
237.5 pounds per acre in the spring,
or 323.0 pounds per acre in the
fall.
PCAACBA
FGATVAK
Quackgrass
Verticillium wilt
[suppression]
Broadcast:
Spring -
161.5-237.5
Ib/A
or
3.71-5.42
lb/1,000
linear ft
of row/
chisel
or
Fall -
237.5-323.0
Ib/A
(94% RTU)
or
Use limited to northwestern states.
Preplant soil treatment. Apply in
the spring or preferably in the
fall.
Issued: 3-06-84
Provisional Update: 8-29-86
II-029001-9
107
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Site and Pest
EPA Compendium of Acceptable Uses
1,3-DICHLOROPROPENE
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
Potato (white) (continued)
5.42-7.42
lb/1,000
linear ft
of row/
chisel
(94% RTU)
Also refer to Field Crops cluster for additional
information.
/01016AA
SABAAAA
IJDAAAA
INAVAAA
/28020AA
NEOBCAA
Small Fruits
Strawberry
Nematodes
Symphylans
Wireworms
Sugar Beets
Broadcast:
228.0-342.0
Ib/A
or
5.27-7.87
lb/1,000
linear ft
of row/
chisel
(94% RTU)
Root-knot nematode Broadcast:
114.0-142.5
Ib/A
or
2.6-3.265
lb/1,000
linear ft
of row/
chisel
or
Row:
57.0 Ib/A
(94% RTU)
or
See Field Crops cluster.
N.F.
Preplant soil treatment through
342.0 pounds per acre (broadcast).
Preplant soil treatment. Apply as
a broadcast treatment on mineral
soil.
N.F.
Preplant soil treatment through
171.0 pounds per acre (broadcast)
or 85.5 pounds per acre (42 inch row
spacing).
Preplant soil treatment. Apply as
specified on mineral soils.
Issued: 3-06-84
Provisional Update: 8-29-86
11-029001-10
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FBCBB
EPA Compendium of Acceptable Uses
1,3-DICHLOROPROFENE
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Sugar Beets (continued)
Sugar beet cyst
nematode
Vegetables
Vine Fruits
4.6 lb/1,000
linear ft of
row/chisel
[42 in. row
spacing]
(942 RTU)
Broadcast:
114.0-171.0
Ib/A
or
2.6-3.93
lb/1,000
linear ft
of row/
chisel
or
Row:
85.5 Ib/A
or
6.9 lb/1,000
linear ft of
row/chisel
[42 in. row
spacing]
(94£ RTU)
Preplant soil treatment. Apply as
specified on mineral soils.
See Field Crops cluster.
See Caneberries cluster.
TERRESTRIAL NON-FOOD CROP
(Agricultural Crops)
Tobacco
See TERRESTRIAL FOOD CROP, (Agricultural Crops),
Field Crops cluster.
(Ornamental Plants and Forest Trees)
/30000DA Forest Trees
/35000AA Ornamental and/or Shade Trees
/32000AA Ornamental Plants (deep rooted)
Refer to TERRESTRIAL FOOD CROP, (Agricultural
Crops), Caneberries cluster.
Issued: 3-06-84
Provisional Update: 8-29-86
11-029001-11
109
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EPA Compendium of Acceptable Uses
1,3-DICHLOROFROPENE
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
'31003AA Ornamental Flowering Plants
'33011AA Ornamental Grasses
'32000AA Ornamental Plants
/33008AA Ornamental Turf
Refer to TERRESTRIAL FOOD CROP, (Agricultural
Crops), Field Crops cluster.
Issued: 3-06-84 11-029001-12
1 10
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