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Guidance for the
Reregistration of
Pesticide Products
Containing Chlordane
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
*
CONTAINING
AS THE ACTIVE INGREDIENT
CHLORDANE
EPA CHEMICAL CODE NO. 058201
Case No. 0173
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OK PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
December 31, 1986
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TABLE OF CONTENTS
I. Introduction
II. Chemical Covered by this Standard
A. Description of Chemical
B. Regulatory History
C. Use Profile
III. Agency Findings .................... n
A. Summary
B. Preliminary Health Risk Assessment
C. Environmental Profile
D. Additional Concerns
E. Tolerances and Action Levels
IV. Regulatory Position and Rationale ........... 27
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard ........... 47
VI. Requirement for Submission of Generic Data ....... 49
A. What are Generic Data?
B. Who Must Submit Generic Data?
C. What Generic Data Must be Submitted?
D. How to Comply with DCI Requirements
E. Procedures for Requesting a Change in Protocol
F. Procedures for Requesting Extensions of Time
G. Existing Stocks Provisions upon Suspension or
Cancellation
VII. Requirement for Submission of Product-Specific Data . . 54
VIII. Requirement for Submission of Revised Labeling ..... 55
IX. Instructions for Submission .............. 56
A. Manufacturing Use Products (sole active)
B. Manufacturing Use Products (multiple active)
C. End Use Products
D. Intrastate Products
E. Addresses
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APPENDICES
1. DATA APPENDICES 59
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES 82
•Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX 109
IV. BIBLIOGRAPHY APPENDICES 126
Guide to Bibliography
Bibliography
V. FORMS APPENDICES 133
FIFRA §3(c)(2)(B) Summary Sheet (EPA Form 8580-1)
Certification of Attempt to Enter Into an Agreement with Other
Registrants for Development of Data (EPA Form 8580-6)
Product Specific Data Report
Formulator's Exemption Statement
ii
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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 FIF'RA. The standards
are applicable to reregistration and future applications Cor
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 the product and labeling
into compliance with FIFRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and are
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 FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request*, 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
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPVs reassessment results in the development of a
regulatory position, contained in this Reqistration Standard,
on the pesticide and each of its registered uses (See
Section IV - Regulatory Position and Rationale). Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. 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 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory acticr.7. such as cancellation
of uses of the pesticide*which have been determined to cause
unreasonable adverse effects on the environment.
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EPA has authority under the Data Call-In (OCX) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the OCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. 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: Chiordane
Chemical name: 1,2,4,5,6,7,8,8-octachloro-2,3,3a,4,7, 7a-
hexahydro-4,7-methanoindene
Other names: 1,2,4,5,6,7,8,8-octachloro-3a,4,7,7a-tetrahydro-
4,7-methanoindan; Velsicol 1068; Velsicol 168;
M-410; Belt; Chlor-Kil; Chlortox; Corodane; Gold
Crest C-100; Gold Crest C-50; Kilex; Kypchlor;
Niran; Octachlor; Octa-Klor; Synklor; Termi-Ded;
Topiclor 20; Chlordan; Prentox; and Penticklor
CAS Registry number: 57-47-9
EPA Pesticide Chemical Code (Shaughnessy) number: 058201
Empirical Formula: CioH6cl8
Molecular weight: 409.8
Chemical/Physical
Characteristics: Color: white (pure); dark amber (technical)
Physical state: crystalline solid (pure); viscous
liquid (technical)
Odor: chlorine odor (pure); cedar-like odor
(technical)
Melting point: 95-96°C (pure)
Boiling point: 118 °C at 0.66 iranHg (technical)
Solubility: insoluble in water; miscible with
aliphatic and aromatic hydrocarbon
solvents, including deoderized
kerosene (technical)
Vapor pressure: 0.00001 mmHg at 25°C (technical)
Density: 1.59 - 1.63 at 25°C (technical)
Stability: loses its chlorine in presence of
alkaline reagents and should not
be formulated with any solvent,
carrier, diluent or emulsifier
which has an alkaline reaction
(technical)
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B. REGULATORY HISTORY
Chlordane was first registered for insecticidal use in the United
States under the early FIFRA in 1948, and was one of the most
widely used household and garden pesticides in the country until
the early 1970's. Structural termite control accounted for the
majority of its non-agricultural use; the primary agricultural
use was as a soil insecticide to control cutworms, wireworms and
rootworms infesting corn. In 1974, the EPA Administrator proposed
cancellation of nearly all registered uses of chlordane and
heptachlor (a structurally related cyclodiene insecticide whose
regulatory history closely parallels that of chlordane1s) for
reasons that included cancer risks, persistence in the environment,
and bioaccumulation throughout the food chain (39 FR 41298). As
cited in the Administrator's Notice, human monitoring data collected
between 1970 and 1972 showed oxychlordane (a major metabolite of
chlordane) present in the adipose tissue of a vast majority of
the American people; and available residue monitoring surveys
showed chlordane to be present in fish, birds, and other wildlife,
and in human food items.
All chlordane uses subject to the Agency's cancellation and
subsequent suspension notices, including all food uses, were
ultimately cancelled. The few uses that were not cancelled in
1978, specifically citrus, grapes, flax, strawberries, non-food/
feed producing land, and nursery stock, were phased out gradually
over specified periods of time, ending between October 1, 1978
and December 31, 1980. Limitations on total production, annual
production, and distribution of technical chlordane for each
phased-out use were imposed. In addition, container size re-
strictions and production/distribution limitations were
imposed for products intended for termite control by the general
public (PR Notice 78-2).
Tolerances for chlordane were not revoked at the time of cancel-
lation for food and feed uses because of the compound's
persistence in the environment and the expectation that residues
would be present in raw agricultural commodities for a significant
time period. However, EPA is now proceeding to revoke these
tolerances and replace them with action levels for unavoidable
residues resulting from environmental contamination, in accordance
with a September 1982 agreement among the Food and Drug
Administration (FDA), the U.S. Department of Agriculture (USDA),
and EPA entitled "Policy Statement on the Revocation of Tolerances
for Cancelled Pesticides" (47 FR 42956). On June 5, 1985
(50 FR 23717), EPA published a proposed rule under the Federal
Food, Drug, and Cosmetic Act (FFDCA) to revoke all tolerances
for residues of chlordane in or on food and feed commodities.
The final rule is scheduled for publication in the Federal Register
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in early 1987. There are also several existing action levels
for chlordane that were previously adopted by the FDA to cover
unavoidable residues in food and feed commodities where no
tolerances had been established. In conjunction with the
revocation of tolerances for chlordane, EPA is recommending
that the existing action levels be retained (see section III.E
of this Registration Standard).
Certain uses of chlordane/heptachlor were specifically exempted
from EPA's suspension and cancellation actions because they were
believed to result in insignificant exposure and, consequently,
insi-gnificant risk. Registrations were retained for subsurface
termite control and dipping of roots or tops of non-food plants;
a use subsequently cancelled voluntarily at the request
of the registrant. Under the Administrator's clarification
notice of July 14, 1975, above ground use of chlordane using
current control practices; which includes a registered wood
impregnation method, was permitted (40 FR 30522).
As an interim regulatory measure early in its review of the
termiticides, EPA initiated, in 1981, a Label Improvement Program
(LIP) intended to reduce the potential risks of termiticide use
primarily by reducing the possibility of misapplication that
may result in contamination of treated structures and high expo-
sures to occupants. For chlordane and other termiticide
products, required label changes included specific precautions
concerning application near vulnerable areas such as domestic
water supplies (cisterns, private wells, etc.)/ near heating
ducts, and around structures with sub-floor crawl spaces, and
warnings against routine (yearly) retreatment.
The termiticide use of chlordane and other pesticides registered
for termite control was subject to a preliminary review of risks
and benefits conducted by EPA, with findings presented in a November
1983 report, "Analysis of the Risks and Benefits of Seven Chemicals
Used for Subterranean Termite Control." This review of the termit-
icides was in part prompted by a General Accounting Office (GAO)
report entitled "Need for a Formal Risk/Benefit Review of the
Pesticide Chlordane," which specifically cited contamination
problems discovered in U.S. Air Force military housing where
chlordane, the most widely used termiticide chemical, had been
applied for termite prevention and control. Rather than focusing
solely on chlordane, EPA took the more comprehensive approach of
reviewing available risk and benefit data on the various termiticide
alternatives, (i.e. aldrin, dieldrin, heptachlor, lindane, penta-
chlorophenol, and chlorpyrifos), as well as chlordane. In summary,
the Agency found that the benefits of the termiticides, particularly
the chlorinated cyclodienes (chlordane, heptachlor, aldrin, and
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dieldrin), were generally very high, but definitive health and
exposure data were lacking to support risk assessments for
regulatory purposes.
Following the issuance of the 1983 report, "Analysis of the Risks
and Benefits of Seven Chemicals Used for Subterranean Termite
Control," EPA issued, early in 1984, a Special Data Call-In
for termitic ides requiring registrants to provide the following
chemical-specific studies to support a more comprehensive risk
assessment of each termiticide:
0 A one-year indoor air monitoring study in homes of various
construction types, treated for subterranean termite control
in accordance with label instructions as revised by EPA's
termiticide LIP;
0 General metabolism studies, one in rats and one in mice,
giving special consideration to pharmacokinetics;
0 Five short-term mutagenicity (gene mutation) assays, and
0 A subchronic inhalation study in rats to assess the potential
toxic response from the inhalation route of exposure
The status of these data requirements for chlordane is as
follows:
Preliminary results from the 90-day pilot phase of the chlordane
indoor air monitoring study have been submitted. EPA has
requested that the registrant submit certain data including
gas chromatography-mass spectroscopy (GS-MS) data in order to
validate and correctly interpret the preliminary results. The
metabolism data required from the registrant have also been
submitted and reviewed. Further metabolism studies are not
required. However, the mutagenicity data requirements have not
been fully satisfied, and additional mutagenicity studies are
being required under this Standard. The requirement for a rat
subchronic inhalation study is not satisfied because the lowest
dose tested in the rat study submitted by the registrant was 20
times higher than the National Academy of Science (MAS) airborne
guideline of 0.005 mg/m3, the lowest dose level requested by
the 1984 Data Call-In. A new inhalation study for chlordane is
required (see Section III.B).
Finally, it should be noted that EPA's Office of Water Regula-
tions and Standards has recommended water quality criteria,
for ambient water concentrations of chlordane. EPA issues such
criteria under section 304(a) of the Clean Water Act, which
requires the Agency to publish criteria for water quality
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reflecting current scientific knowledge or. the kind and extent
ot all identifiable effects on health and welfare which may be
expected from the presence ot pollutants in any body of water,
including ground water. These ambient water quality criteria
are non-regulatory in that they do not in themselves represent
enforceable regulatory standards. However, they may be adopted,
with or without modification, by individual States and may thus
become enforceable State water quality standards. Typically,
States may modify EPA's criteria to reflect local environmental
conditions and human exposure patterns.
The ambient water quality criteria recommended tor chlordane
and its supporting scientific assessment is described in a
1980 document, '"Ambient Water Quality Criteria for Chlordane.
(EPA 440/5-8U-027)," which is publicly available through the
National Technical Information Service (NTIS), Springfield,
Virginia 22161 (telephone: 703-487-4650). Specific criteria,
expressed as maximum concentration levels per liter of water,
are recommended (1) tor protection of tresh-water and salt-water
aquatic life from acute toxic effects of chlordane, and (2) for
protection of human health due to exposure to chlordane through
ingestior. of contaminated water or contaminated aquatic organisms,
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C. USE PROFILE
The basic producer of chlordane in the United Sates is Velsicol
Chemical Corporation. In 1980, chlordane accounted for more than
80 percent (9.5 million pounds of active ingredient) of the
total amount of pesticides used for termite control in the United
States. In 1985, the overall use of pesticides for termite
control had declined by almost 50 percent from 1980 due primarily
to a decrease in chlordane/heptachlor use; chlordane was still
the termiticide of choice, accounting for 60 percent (3.0 to
3.5 million pounds of active ingredient) of the total use in
that year period.
Chlordane is used for subterranean termite control either as
a preconstruction treatment for preventing termite problems or
as a post-construction, remedial treatment. The termiticide is
typically applied along the inside and outside of foundations;
around the bases of supporting piers, chimney bases, plumbing
and conduits; under filled porches, entrances and terraces;
under floor structures resting on soil or gravel fill; and
exposed soil areas under structures. Effective treatment
requires the establishment of a chemical barrier between the
wood in the structure to be protected and the termite colonies
in the soil. Current control practices include trenching,
rodding, subslab injection, and low pressure spray application.
The State of California's 24(c) "special local need" registra-
tions allow for limited use of the pesticide in crawl spaces
where conditions do not permit trenching or rodding; application
cannot be made more than 18 inches, horizontally, from the
foundation, and piers or pipes, and certain structures cannot
be treated in this manner (i.e. houses with gravity type heating
systems). The territory of Guam and State of Hawaii have each
issued a special local need registration for underground cable
soil treatment for termite control.
Chlordane is generally formulated into 4 and 8 pound per gallon
concentrate formulations for use by pest control operators and the
general public. In most states pest control operators
must be certified under 40 CFR 171.4 as commercial applicators.
One product is a 20 percent pelletted formulation of chlordane,
consisting of cartridges from which chlordane is inserted into
the soil surrounding dwellings by use of a special soil injector.
This product is intended for use by homeowners.
Chlordane, formulated in combination with copper 8-quinolinolate,
is registered for the above ground preservative treatment of
structural wood to control fungi, termites, and other wood-
destroying insects. Application to wood surfaces is made by
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brush, spray, or dip. This has not been a restricted use
pesticide. There are one hundred and sixty-six federally
registered end-use products containing chlordane as the sole
active ingredient^/. With the exception of one granular product,
these are all emulsifiable concentrate (EC) formulations (generally
4 and 8 pound per gallon concentrates). Six EC end-use products
contain chlordane in combination with heptachlor. In addition,
one end-use product contains chlordane in combination with
copper 8-quinolinolate. Velsicol Chemical Corporation produces
seven formulation intermediates (three ot which are chloraane/
heptachlor combinations) and three technical products.
There are four "special local need" registrations under FIFRA
section 24(c) issued to: California (CA-810011, CA-81U012);
Hawaii (HI-810007); and the U.b. territory of Guam (GU-81U001).
There are five intrastate products.
The Agency considers all currently registered end-use products
containing chlordane in combination with solvents or diluents
to be sole active ingredient formulations. The Agency does not
consider the solvents or diluents in these formulations to be
insecticidal, and therefore must be declared as inerts.
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III. AGENCY FINDINGS
A. SUMMARY
The Agency has reviewed all data currently supporting the
registration of chlordane. Based on the available data, EPA has
reached the following conclusions. The points summarized
below are presented in further detail, in the context ot
EPA's science findings and additional data requirements, in
Sections B through D.
1. Technical chlordane appears to be moderately acutely
toxic through all routes of exposure. Additional data
are required to fully assess the acute oral, dermal, and
inhalation toxicity of this pesticide, as well as the
subchronic inhalation toxicity.
2. The Agency has concluded that the available data do not
indicate that chlordane causes acute delayed neurotoxic
effects.
3. Chlordane exposure may pose a significant health risk ot
chronic liver effects to occupants ot structures treated
with chlordane.
4. The termiticide use of chlordane may also pose an oncoyenic
risk of regulatory concern. Chlordane is oncogenic in
laboratory mice and rats. Evidence is based on findings
of increased incidence of liver carcinomas in ICR, CD-I
and B6C3Fi mice, and in Fischer 344 rats. EPA will
consider the forthcoming results ot the inaoor air monitociny
study now underway to determine whether human exposure
from the termiticide use of chlordane results in risks of
cancer and chronic liver effects that may warrant regulatory
action. The final results of this monitoring study are
scheduled for submission to the Agency in February, 1986.
5. The Agency was recently apprised of three reported cases
of optic neuritis (an inflammation of the optic nerve)
associated with termiticide treatment ot homes with
chlordane. To determine whether this human health effect
is significant, the registrant must have eye tissue from
the 1983 Research Institute for Animal science in Biochemistry
and Toxicology (RIASBT) rat oncogenicity study analyzed
by neuropathologists specializing in optic tissue pathology.
Since the RIASBT study utilized animals exposed via the
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oral route (as opposed to inhalation which may not produce
100% absorption of the test material), if an effect is
present, it should be easily discerned from this type of
exposure.
6. Laboratory data show that technical chlordane is very
highly toxic to freshwater fish, freshwater invertebrates,
and birds. There are no ecological effects data gaps at
this time.
7. Chlordane has been found in fish at levels exceeding the
U.S. Food and Drug Administration action level at various
aquatic sites in Iowa, Missouri, and Nebraska. Prelim-
inary evidence indicates that the source of this contamination
may be surface water run-off from the pesticide's termiticidal
use. For this reason, the Agency is requiring a special
study which is intended to provide information on (1)
whether the termiticide use of chlordane results in
residues of chlordane in drinking water and in fish for
human consumption, and (2) whether fish and freshwater
invertebrates are at risk of being exposed to toxic
levels of chlordane as a result of its termiticide use.
8. The extent of potential exposure to aquatic endangered
species cannot be assessed until the results of the
required surface water monitoring study are received.
9. The Agency is restricting the use of chlordane termiticide
products to Certified Applicators as specifically defined
in the label provisions prescribed by EPA in this Registra-
tion Standard. The Agency considers the subterranean
termiticide application to be complex and to require a great
deal of specialized knowledge and training not typical
of other pesticide applications. The Agency is also
concerned with the potential oncogenicity of these
products and potential exposure to occupants of treated
buildings. Data available to EPA show occurrence of
misuse and misapplication of chlordane termiticide
products (refer to Section III.D). The Agency believes
that restricting its use would minimize inadvertent
misuse and/or misapplication.
10. Although negative for mutagenic activity in bacteria,
further testing in mammalian cell systems must be submitted
to complete regulatory requirements for mutagenicity,
specifically; mammalian cell gene mutation assays, somatic
cell cytogenetic assays and assays for sister-chromatid
exchange. The Agency is also requiring additional testing
for promotional (epigenetic) activity.
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As a result of this Registration Standard review, the Agency
has determined that certain additional or revised label
restrictions are necessary. These include:
0 Restricted use classification
0 Revision of Existing Use Instructions
0 Pesticide disposal procedures
0 Worker protective clothing statements
0 Fish and wildlife toxicity warnings
0 Statement on carcinogenic and adverse liver effects in
laboratory animals.
The Agency has also identified missing data necessary to fully
evaluate the human and environmental risks associated with the
use of chlordane as a termiticide. These data must be developed
in order to maintain registrations of existing products or
register any new products containing chlordane. A summary of
these data gaps is given in Table 1. Please note that this
is only a summary and complete details can be obtained by
referring to the Tables in Appendix I.
EPA will continue to evaluate the termiticide use of chlordane
in terms of the regulatory concerns identified in this Regis-
tration Standard as additional information becomes available.
The Agency will continue to evaluate the risk of chronic
liver effects in humans from exposure to chlordane, and also its
potential oncogenicity and determine whether additional
regulatory action is warranted.
The Regulatory Position and Rationale section of this Registration
Standard discusses the Agency's position on each of the regulatory
issues concerning chlordane, and the Required Labeling section
contains the specific wording required for each of the labeling
provisions.
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TABLE 1. SUMMARY Of DATA GAPS
(Please refer to the tables in Appendix 1 for detailed
information regarding these requirements)
Toxicology
Battery of acute toxicity studies
Subchronic inhalation study — rats (one-year)
— rats or guinea pigs (two-weeks)
Chronic Feeding — non-rodents and rats
Mutagenicity studies
Teratogenicity — rats and rabbits
Reproductive Effects — rats (2-generation)
Optic tissue pathology — rats
Environmental Fate/Exposure
Hydrolysis study
Aerobic and anaerobic soil metabolism studies
Aerobic aquatic metabolism study
Leaching and aasorption/desorption study
Soil dissipation: field study
Photodegradation in water
Special monitoring study of chlordane residues entering surface water
from sanitary sewers, sumps, and drainage tiles from home
foundations known to have been properly treated with chlordane
Applicator exposure studies
Indoor air exposure studies
Fish and Wildlite
No data requirements at this time.
[Pending the results ot the surface water special monitoring study
and other environmental fate data, additional fish and wildlite
data requirements nay be imposed. These include, but are not
limited to monitoring of residues of chlordane in aquatic
sites and chronic fish and wildlife toxicity studies.]
Product Chemistry
All product chemistry studies
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B. PRELIMINARY HEALTH RISK ASSESSMENT
Numerous data gaps exist for chlordane and few definitive conclusions
can be made pending receipt of additional data. The following
assessment is based on the data available.
Acute Toxicity. Adequate data are not available to fully
assess the acute toxicity of chlordane and additional studies
are therefore required on acute oral, dermal, and inhalation
toxicity. Reported signs of acute intoxication of chlordane
are similar to those for the other cyclodiene pesticides,
and are primarily related to the central nervous system
(CNS). Symptoms include hyperexcitability, convulsions,
depression, and death. There have been numerous incidents
of acute intoxications in humans from chlordane exposure
among chemical plant workers; however, recovery has been
complete and relatively rapid following removal from the
exposure area. Based on direct human evidence from these
incidents, and the dissimilarity of chlordane to known
neurotoxic agents (i.e., organophosphates), the Agency
concludes that based on the available data, chlordane does
not appear to cause acute delayed neurotoxic effects. For
this reason, a delayed neurotoxicity study is not required.
The Agency also concludes that chlordane does not appear
to be a skin sensitizer, again based on human exposure data.
The data supporting this conclusion concern chemical plant
workers who experienced the kind of repeated skin contact
which is simulated in dermal sensitization studies under
laboratory conditions without experiencing dermal sensitiza-
tion. In addition, results from a dermal sensitization
study performed on white guinea pigs showed technical
chlordane not to be a skin sensitizer (00103884).
However, product-specific data are required so that EPA may
assess the potential of chlordane products to cause primary
eye and dermal irritation. The purpose of the requisite
primary dermal irritation testing is to determine the irritative
or corrosive effects of a single dermal exposure at a dose
level that is considerably higher than the dosage used in skin
sensitization testing. The results of these primary eye and
dermal irritation studies will be considered together with
the results of. required acute toxicity testing in determining
the appropriate toxicity category for chlordane. The
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Agency does have acceptable primary eye irritation data to
place a 72% technical chlordane (or 8 EC) product in Toxicity
Category I (GS0173-001) .
2. Subchronic Toxicity. As noted previously in Section II.B, a
subchronic inhalation study in rats was among the studies
originally required by EPA through the Special Data Call-In
issued for chlordane in February 1984. The registrant
submitted two 90-day studies using rats and monkeys; NOEL's
derived from these studies were determined to be 0.1 mg/m3
and 1.0 mg/m3, respectively. The rat study is not considered
adequate because the lowest dose tested was 20 times
higher than the NAS guideline level of 0.005 mg/m3, the
lowest dose level requested in the 1984 Data Call-in.
The Agency has determined that the new rat inhalation study
must be performed for a period of one year, rather than 9-0
days/ as this exposure period more likely refects typical
human exposure resulting from termitic ide use. The registrant
must also use the NAS guideline level for the lowest dose
level.
In available subchronic feeding studies with rats and mice,
the primary subchronic effects exerted by chlordane and its
metabolite oxychlordane were reported to be those of the
liver; endoplasmic reticulum hypertrophy, enlarged central
hepatic lobule cells, increased liver weight and liver
lesions. This cellular degeneration and histopathological
changes in the liver is known as chlorinated hydrocarbon
insecticide rodent liver (CHIRL). In one short-term study
in which small groups (6/sex/dose) of rats were fed either
2.5 or 25 ppm of technical chlordane for up to 9 months,
effects at the 2.5 ppm dosage level were noted in the
liver. A Lowest Effect Level (LED of 2.5 ppm was established
for the CHIRL effect (GS0173-002). In another 90-day study
with oxychlordane using rats in which groups of 20 males and
20 females were fed 5, 25, or 50 ppm of oxychlordane in the
diets, results indicated that oxychlordane is more acutely
toxic than the parent compound. A subchronic non-rodent
study has not been submitted to the Agency. However, the
Agency is not requiring a study since the results from the
non-rodent chronic feeding studies can be translated to
this subchronic feeding study.
Pending the results of the required acute dermal toxicity
study, the requirement for a 21-day dermal study is reserved.
The registrant must conduct additional inhalation studies of
two week duration with either guinea pigs or rats to further
delineate the irritative capabilities to mucous membranes
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of chlordane, formulation solvents or the combination
(i.e. formulated product).
3. Chronic Toxicity! Liver Effects and Oncogenicity; Setting
a PAD I
Liver Effect and PADI. Administration of chlordane in
subchronic and chronic feeding studies in mice, rats and dogs
has resulted in CHIRL. Liver toxicity occurred at a dose
level of 1.0 part per million (ppm), equivalent to 0.05
milligrams per kilogram body weight per day (mg/kg/day) ,
the lowest dose tested in a rat feeding study with chlordane
(GS0173-003) . Based on this lowest effect level (LED of
0.05 mg/kg/day, EPA has calculated a provisional acceptable
daily intake (PAD!) level for chlordane, for effects other
than oncogenicity, of 5.0 x 10~5 mg/kg/day, by applying a
1,000-fold uncertainty factor. This calculated estimate is
provisional because the existing data base for chlordane is
lacking the following toxicology data: chronic toxicity in
rats and dogs, rat and rabbit teratology, rat reproduction,
and mutagenicity.
Oncogenicity. During the heptachlor/chlordane suspension
and cancellation proceedings conducted between 1974 and 1978,
the existing data concerning the oncogenicity of both compounds
were subject to intensive evaluation. An updated assessment
of the carcinogenic risks of chlordane and heptachlor has been
conducted by EPA's Carcinogen Assessment Group (CAG) in
accordance with the Agency's Proposed Guidelines for Carcinogen
Risk Assessment (49 FR 42694; November 23, 1984). Based on
this assessment (GS0173-004) , chlordane has been classified
as a Group 82 (i.e, probable human) carcinogen, with a cancer
potency estimate (Q~l*) of 1.3 per mg/kg/day.
The Agency's 1984 Proposed Guidelines describe the general
framework to be used in developing an analysis of carcinogenic
risk with regard to assessing the weight of evidence of
carcinogenicity from human and animal studies. Based on the
weight-of-evidence analysis of available data, chemicals
are categorized with regard to their potential human
carcinogenicity. Under EPA's classification system,
Group A classification, "Human Carcinogen," is reserved
for those chemicals for which there is sufficient evidence
of carcinogenicity from human epidemiological studies.
Group B, "Probable Human Carcinogen," is divided into
subgroups 1 and 2. Group B} requires some human
epidemiological evidence. Since existing epidemiological
studies of chlordane provide inadequate evidence for
17
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carcinogenicity due to methodological and data limitations,
EPA does not have reason to classify chlordane as Group A or
Bl-
under the carcinogen risk assessment guidelines, chemicals
are categorized as Group 82 carcinogens if there is "sufficient
evidence" of the chemical's carcinogenicity from animal
studies. Sufficient evidence of carcinogenicity is indicated
by an increased incidence of tumors: (a) in multiple species
• or strains; or (b) in multiple experiments (e.g.), with
different routes of administration or using different
dose levels); or (c) to an unusual degree in a single
experiment with regard to high incidence, unusual site or
type of tumor, or early age at onset. Group C ("Possible
Human Carcinogen") chemicals are so classified if there is
"limited evidence" from animal studies. There is also a
Group D ("Not Classified") and a Group E that is reserved
for chemicals shown to be non-carcinogenic in animal
and/or human studies.
In classifying chlordane as a Group 82 carcinogen, the Agency
considered all currently available data in both mice and rats.
In mice, three long-term carcinogenicity bioassays of chlordane
independently conducted by investigators affiliated with
the National Cancer Institute (NCI 1977), the Research
Institute for Animal Science in Biochemistry and Toxicology,
Japan (1983), and the International Research and Development
Corporation (IREXZ, 1973) are considered adequate for risk
assessment by current scientific standards. In these
studies, chlordane was found to produce significant liver
tumor responses in three different strains of mice (IRC,
CFi, and B6C3Fi) in both males and females at both medium
and high doses, with a dose-related increase in the
proportion of tumors that were malignant. In rats, the
available data from the Research Institute for Animal
Science in Biochemistry and Toxicology (1983), using
Fischer 344 rats, are considered adequate and conclusive.
In this study, there was a significant increase in adenomas
of the liver in males receiving 25 ppm as compared to
controls, but not in females.
The available evidence in mice and rats is considered
sufficient laboratory evidence to warrant the classification
of chlordane as a Group 82 / probable human carcinogen.
Further support for this classification comes from the
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available evidence on the carcinogenicity of heptachlor, and
the induction of tumors by other chemicals such as aldrin and
dieldrin, which are structurally related to chlordane.2/
Risk Assessment for Liver Effects and Oncogenicity. The Agency
has received and evaluated preliminary results covering the
first 90 days of a one-year indoor air monitoring study. The
study reflected treatment of slab and crawl space (but not
basement) houses with the pesticide product Termide, a
formulation consisting of a 2:1 mixture of technical chlordane
to technical heptachlor. In the samples collected/ quanti-
tative determinations were made for ambient air levels of
4 chlordane isomers, trans-nanachlor and heptachlor. The
registrant reported that airborne residue consisted principally
of heptachlor, with the chlordane isomers accounting for only
a minor proportion. This finding conflicts with data available
in the literature, which demonstrate chlordane as the primary
residue. Because of this discrepancy, the Agency in conjunction
with its Beltsville, Maryland laboratory, is working with the
registrant of the study to validate the air monitoring data.
In order to validate the air monitoring results, the registrant
must verify by gas chromatography-mass spectroscopy (GC-MS)
whether chromatographic peaks have been correctly identified as
one of the four chlordane isomers, trans-nonachlor or heptachlor;
determine whether all major epoxide breakdown products/ especially
oxychlordane and heptachlor epoxide, are present in ambient
air; and identify the significant peaks (reflecting greater
than 5% detector response above baseline) not presently
quantitated.
Nevertheless, EPA is concerned over the potential human
health risks of chlordane based on limited literature values
for ambient air levels of chlordane/heptachlor in treated
homes, coupled with chlordane's extremely low PADI
(5 x 10~5), and high cancer potency value (Q*~lss 1.3 per
nig/kg/day). EPA will be considering the results of the indoor
air monitoring study, once the validation data are received/
together with evidence on the oncogenicity of chlordane to
determine whether human exposure to chlordane may be posing a
human health risk of regulatory concern.
4. Metabolism. There are numerous studies available describing
the various aspects of chlordane metabolism. Single dose
absorption studies in rats suggest that a large percentage of
Heptachlor, aldrin and dieldrin have also been classified as
Group 82 (probable human) carcinogens, based on significant
tumor responses in multiple strains of mice.
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14C-label is eliminated in feces via the bile with only about 6
percent excreted in the urine. On the other hand, rabbits were
found to excrete from 30 to 50 percent in the urine of the total
dose in a multiple dose study. Respiratory absorption has been
studied in rats using 14C-labeled chlordane and it was reported
that the test animals did not absorb 100 percent of the test
material inhaled; only 42 to 80 percent of the total l*c respired
was retained in the body following an inhalation period of from
15 to 45 minutes. Data on tissue distribution of the 14C-label
from cis or trans chlordane in a study using rats suggest that
at 1 day after a single oral dose only fat tissues contained
appreciable 14C-residues. Residues in fat tissue were higher in
females than males and trans chlordane treatment resulted in
higher residues in both sexes than the cis isomer. Oxychlordane
has accounted for 50 to 60 percent of fat tissue residues following
a single dose after 24 hours. Oxychlordane generally remains in
the body fat after administration by the oral route. Only 21
percent of Oxychlordane was excreted after 7 days compared
to approximately 90 percent for either isomer of chlordane.
However, the route of excretion, the feces, was the same as
for the chlordane isomers. Although Oxychlordane has
been found to be a major fat tissue residue in rats, human fat
samples frequently contain trans-nonachlor, a contaminant
found in technical chlordane, as the major residue. It is
thought that the rat liver readily metabolizes trans-nonachlor
and allows a greater subsequent excretion rate than does the
human liver.
5. Mutagenicity. The Agency has reviewed eighteen published
articles, consisting of a total of 34 assays with technical
chlordane, some of which were submitted in response to
the February, 1984 Data Call-in Notice. Of these, only
one-third were found to be acceptable. Based on a review of
these assays, the Agency has reached the following preliminary
conclusions.
a. Neither technical chlordane nor any of its constituents
appear to be mutagenic in bacterial cells in adequately
controlled assays.
b. Chlordane's potential to induce gene mutation in
adequately controlled assays (i.e. with and without
metabolic activation in the standard in vitro mammalian
assays) needs to be determined.
c. Adequate germinal assays indicate chlordane does
not cause gross chromosome damage, but its potential
for somatic cytogenetic activity has not been
evaluated.
20
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d. The combined results of DNA repair assays indicate that
chlordane (the technical and/or one of its constituents)
is genotoxic in yeast and fish, as well as in some
types of mammalian cell systems.
e. There is evidence that chlordane, as with the other
organochlorines, acts as a promoter, rather than
initiator of cancer, although additional testing
in mammalian cell systems is necessary to affirm
the apparent absence of potential for direct genotoxic
activity.
To complete regulatory requirements, the Agency is requiring
additional testing, specifically; gene mutation assays
with and without metabolic activation in accordance with
acceptable procedures, in vivo mammalian assays for chromosome
aberrations in somatic cellsTe.g., rodent bone marrow) and
in vitro assays for SCE (with and without activation). In
addition, the Agency is requiring the following stidies to
investigate promotional activity: in vitro transformation with
promotion assay and i.n vivo promoting activity assay.
6. Teratology and Reproduction. Data gaps exist in both
these areas of toxicity testing.
7. Applicator Risks. Because data on chlordane, including
surrogate data, are not available to characterize applicator
exposure, the Agency is unable to assess the risks posed
to pesticide applicators as a result of dermal and
respiratory exposures to chlordane during application.
In order to evaluate the risks of occupational
exposure to chlordane, the Agency is requiring the
submission of appropriate dermal and respiratory data
from applicator exposure monitoring studies.
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C. ENVIRONMENTAL PROFILE
Ecological Effects. There are no ecological effects data
requirements at this tine. Existing data are adequate
to show that chlordane is potentially very highly toxic
to both warm-water and cold-water fish species. The 96-
hour LCso for cold-water species (rainbow trout) ranges
from 42 to 90 ug/L, and for warm-water species (bluegill)
ranges from 57 to 74.8 ug/L. Chlordane is potentially
moderately to highly toxic to birds, depending upon the
species of bird. In acute toxicity tests chlordane was
found to be moderately toxic to the mallard duck (LCso
= 858 ppm) and highly toxic to bobwhite quail and pheasant
(LCso's = 331 ppm and 430 ppm, respectively). In an
acute toxicity test, chlordane was moderately toxic to
bobwhite quail with an LDso of 83.0 mg/kg.
Chlordane has been reported to cause adverse effects to
birds in the field; it was reported to be primarily
responsible for the deaths of three raptors (two red-
shouldered hawks and one great horned owl) between 1978 and
1981. The source of the chlordane was not determined,
but the study suggests that bioaccumulation of chlordane
in the environment can result in hazardous levels and
that there may be a concern for biomagnification in the
food chain.
This propensity to bioaccumulate could also cause chlordane
to produce secondary chronic effects in exposed organisms.
If the results of environmental fate data and/or monitoring
data being required to determine whether the termiticidal
use of chlordane may be contaminating surface waters
should raise concerns about potential chlordane exposure
to fish or fresh-water invertebrates, special monitoring
of aquatic sites and chronic fish and wildlife studies
may be required.
Endangered species. EPA does not have reason to believe that
the termiticide use of chlordane threatens any endangered
species at this time. Concerns may be raised depending
upon the results of the surface water monitoring study
(see below).
Environmental Fate. The Agency is unable to fully assess
the environmental fate of chlordane because acceptable data
are lacking. However, available supplementary data do indicate
general trends of chlordane behavior in the environment.
Chlordane is a persistent chemical and appears to be relatively
immobile in the environment. Chlordane applied at 9 kg
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active ingredient per hectare to turf with an underlying
sandy loam soil, was 1.6 to 2.1 ppm in the root zone (0-1
cm depth) and < 0.3 ppm in the soil zone (1 - 3.5 cm depth)
during the 56 days following treatment. Total residues after
56 days declined to 69 per cent of the originally applied
material. In another study in which chlordane was
applied to the surface of a lake, the concentration of chlordane
in the water was 4 to 5.5 ppb after 7 days and 0.008 to .011
ppb after 421 days. In lake sediments the concentration
reached 20 to 30 ppb during the first 279 days after application,
and 10 ppb 421 days after application. In studies conducted
in Beltsville, Maryland in 1951, where chordane was
applied to sandy loam soil at rates of 56, 112, and 224
kg/ha, 83% of that applied was still in the soil in 1952, and
45% of chlordane was present 15 years after application.
Chlordane is not expected to leach, since it is insoluble
in water and should adsorb to the soil surface. However,
additional data are necessary to fully assess the potential
for ground-water contamination as a result of the termiticide
use of chlordane.
To assess the environmental fate of chlordane in conjunction
with its domestic outdoor use pattern, the Agency is
requiring the following studies: hydrolysis; aerobic and
anaerobic soil metabolism; aerobic aquatic metabolism;
leaching and/or adsorption/desorption; terrestrial
field dissipation; and photodegradation in water. In
addition, a number of data requirements are reserved.
Aquatic sediment dissipation data may be required pending
the results of the aerobic aquatic metabolism study. A
fish accumulation study is reserved pending the results
of the product chemistry requirement for an octanol/
water partition coefficient study. Finally, depending on
the results of the indoor air monitoring study now in
progress, further testing may be required-in this area.
In addition, a special monitoring study is being required to
determine the extent of surface water contamination from the
termiticide use of chlordane. The purpose of this study is two-
fold: (1) to determine whether and to what extent termiticide
applications are resulting in residues of chlordane
in drinking water and in fish for human consumption, and (2)
whether fresh-water fish and invertebrates are at risk of
being exposed to toxic levels as a result of chlordane's
termiticide use.
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This requirement arises from recent finding of chlordane in
fish at levels exceeding the FDA action level at various
urban aquatic sites in Iowa, Missouri and Nebraska,
coupled with preliminary data indicating that the source
of contamination may be surface water run-off associated
with its termiticidal use. In 1985, the Iowa Department
of water, Air, and Waste Management sampled urban sources
of chlordane, representing a range of potential urban
sources. While sampling of storm sewers yielded negative
results, trace amounts of chlordane were found at a
water treatment plant (0.18 ppb), a sanitary sewer showed
measurable amounts (2.5 and 4.7 ppb), and a significant
amount of chlordane was found in a sump pump (180 ppb).
These preliminary findings on chlordane raise the question
whether the termiticide use of chlordane could be contaminating
surface water.
D. ADDITIONAL CONSIDERATIONS; CHLORDANE COMPLEXITY OF USE
AND MISUSE/ MISAPPLICATION
For the purpose of assessing the human health and environ-
mental risks of chlordane, as discussed in this Registration
Standard, EPA has assumed the proper use of chlordane as a
termiticide in accordance with label directions. However,
reports to EPA have indicated a significant incidence of
misuse and misapplication of chlordane by professional
applicators employing soil injection and trenching methods.
The data indicate that applicators have inadvertently
contaminated structures while applying chlordane into
prepared injection holes or trenches. These types of
incidents underscore the need for applicators to be
knowledgeable about building construction elements or
anomalies. When applying chlordane by soil treatment
methods, it is generally necessary for applicators to
take appropriate site-specific precautions. Different
types of house construction (rubble foundations, crawl
spaces, etc.) require different methods of treatment
as well as techniques to avoid contamination of venti-
lation systems and other vulnerable areas (electrical
conduits, heating pipes or lines, water supplies, etc.).
From an economic standpoint, ignorance or insufficient training
regarding these factors can result in significant property
damage. Reports indicate that such damage may involve
extensive costs, in some instances requiring new ventilation
systems, decontamination of drinking water, or replacement
of carpeting and wall paneling in the contaminated area.
From a health risk standpoint, contaminated air systems
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may result in unnecessarily high/ long-term human exposure
to chlordane over and above levels that may be anticipated
on the basis of controlled ambient air exposure monitoring.
Additionally, the improper use of chlordane has the
potential 'to result in environmental contamination. For
these reasons, considered together with the toxic properties
of chlordane and its potential to persist and bioaccumulate
in the environment, EPA is requiring that chlordane be
restricted for retail sale to and use by Certified Applicators
or persons under their direct supervision, as specifically
defined in section IV.A.2 of this Registration Standard.
It has been six years since EPA initiated the Label
Improvement Program (LIP) for termiticides. The LIP was
designed to improve pesticide labels in order to protect
health and environmental safety and to assist the user
and the enforcer to clearly understand what practices
constitute legal use. The Agency now believes there is a
need to upgrade the termiticide LIP regarding use instructions
and precautionary statements to further minimize potential
exposure to both homeowners and commercial applicators
(i.e. retreatment restrictions and prohibition against
use in plenum housing). The required label changes are
prescribed in further detail in Section IV.D (Required
Labeling).
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E. TOLERANCES AND ACTION LEVELS
Prior to the cancellation of all food and feed uses of chlordane,
tolerances for total residues of chlordane, resulting in or
on raw agricultural commodities from application of chlordane
were established as listed in 40 CFR 180.122 and 40 CFR
180.319. As noted in Section I.B of this Registration Standard,
tolerances were not revoked concurrently with these cancellations
because of chlordane's slow rate of degradation and its persistence
in the environment. However, EPA is now proceeding to revoke
'these tolerances in accordance with a 1982 agreement among
EPA, FDA, and USDA, entitled "Policy Statement on the Revocation
of Tolerances for Cancelled Pesticides" (47 FR 42956). This
policy statement describes when and how tolerances will be
revoked and action levels substituted for certain pesticides
for which registered uses have been cancelled, and what
factors will be considered in recommending action levels for
pesticide residues occurring in food and animal feed commodities
as a result of environmental contamination.
The revocation of tolerances supporting previous agricultural
uses of chlordane, and EPA's recommendations concerning action
levels to replace these tolerances, is independent of this
Registration Standard, and is being completed through formal
rulemaking. The proposed rule to revoke all tolerances for
residues of chlordane under the Federal Food, Drug, and
Cosmetic Act (FFDCA) was published June 5, 1985 (50 FR
23717} and public comment was invited. The final rule
is scheduled for publication in the Federal Register in early
1987.
In addition to action levels to replace existing tolerances,
EPA is recommending that the existing action levels for
(rendered) animal fat (0.8 ppm), processed animal feed
(0.1 ppm), fish (0.3 ppm), and fat of meat from goats, cattle,
hogs, horses, sheep, poultry and rabbits (0.3 ppm) be retained.
When additional data on current residue levels and fish
consumption patterns are collected and analyzed by the Agency,
EPA will reassess the present 0.3 ppm action level for fish.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data on hepta-
chlor, the Agency has made the following determinations. Refer
to Section IV.D. for specific language for label revisions.
1. EPA is currently evaluating the potential human health risks
of (1) non-oncogenic chronic liver effects, and (2) oncogenic
effects to determine whether additional regulatory action
on chlordane may be warranted.
Rationale; EPA has received and evaluated preliminary results
covering the first 90 days of a one-year indoor air monitoring
study. The Agency found significant problems with the study
and is working closely with the registrant to resolve the
issues. The Agency will conduct a quantitative risk assessment
when adequate validation data have been received and evaluated.
EPA is concerned about the potential human health risks of
chlordane based on limited literature values for ambient air
levels of heptachlor/chlordane in treated homes, coupled with
chlordane's extremely low PADI (5 x 10~5 mg/kg/day) and high
cancer potency value (Q*~l =1.3 per mg/kg/day). EPA will be
considering the results of the indoor air monitoring study,
together with the evidence on the oncogenicity of chlordane
to determine whether human exposure to chlordane may be
posing a human health risk of regulatory concern.
2. In order to meet the statutory standard for continued registra-
tion, the Agency has determined that the retail sale and use
of all end-use products containing chlordane for termite control
must be restricted to Certified Applicators or persons under
their direct supervision, as specifically defined in the
"Restricted Use Pesticide" label provision prescribed by EPA
in Section IV.D. of this Registration Standard. As this
label provision states, direct supervision of a Certified
Applicator means one of two options regarding the use of
chlordane products: (a) the actual physical presence of the
Certified Applicator at the application site during application,
or (b) if the Certified Applicator is not physically present
at the site, each uncertified applicator must have completed
a State-approved training course in termiticide application
meeting minimal EPA training requirements and be registered
in the State in which the uncertified applicator is working;
after a determination by the State of the individual's
competence.
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If States elect to implement the second option provided on the
label, then specific, minimum training and registration criteria
set forth by EPA must be adopted and followed by the State.
Training may be conducted by industry or other groups provided
minimum EPA and State training standards are met. Technicians
will not be considered competent until the State has determined
that they are competent. Any necessary State legislation
and/or regulations will have to be in place before EPA will
approve a State program. Before States may exercise this
option, a description of their program, including training
requirements, approach for determining competence, and
registration process must be submitted to and approved by
EPA under guidance established by the Agency's Pesticide
Certification and Training Office. States may choose to
adopt measures more restrictive than those set forth in this
Registration Standard.
A State desiring to establish a registration program for termiticide
technicians must present to the Agency for approval a program
and plan consisting of at least the following elements:
* Training to include basic information on;
a. Application equipment, rates of application, and mixing,
loading, and handling procedures for chlordane products;
b. Detailed information on construction elements of the
structures likely to be encountered when applying chlordane,
and the appropriate and proper application methods for
each construction element;
c. Operation, care, and maintenance of application equipment
and protective equipment and apparel;
d. Comprehension of label information and restrictions;
e. Environmental and human health consequences of termiticide
misuse including the acute and chronic health hazards of
chlordane, potential impact on water supplies, and potential
impacts on the environment and treated structures;
f. Techniques for decontamination, if possible, of structures
should an accident or misapplication occur;
g. Safety in storage and disposal of chlordane, chlordane product
containers, unused chlordane solution, and contaminated
protective equipment and clothing;
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h. Emergency procedures, should an accident occur, for the
protection of the applicator and the occupants of the
treated structure, and warning signs of misapplication that
would be useful to communicate to the occupants.
Training developed by industry or others in support of
this second option shall be submitted for review and approval
to appropriate State regulatory agencies in States which
have a termiticide technician registration program. Such
training materials or programs must include at least the
above listed elements plus any other requirements which a
State might specify.
0 Competence demonstrated by; a process or method whereby the
State can determine, by examination or other methods acceptable
to EPA, that' the person is competent to apply the product.
0 Registration by; a system of registration with the state
after the applicant has demonstrated to the State a satis-
factory level of competence in termiticide application.
Rationale; As stated in 40 CFR 162 .11(c)(4) , pesticide
products may be classified for restricted use if there is
evidence that the product "may pose a serious hazard to
man or the environment which can reasonably be prevented
by classification for restricted use." The Agency considers
the subterranean termiticide application to be complex and
require a great deal of specialized knowledge. Data reported
to EPA indicate recurring misuse and misapplication of chlordane
termiticide products by pest control operators. In view
of the potential health hazards associated with exposure
to chlordane, the Agency is concerned about long-term and
acute exposures which may result from the improper use of
chlordane. The Agency is especially concerned about the
contamination of air systems in structures improperly
treated for termite control, since such contamination may
• result in unnecessarily high, long-term exposure to
chlordane over and above levels that may be anticipated
following proper applications. In addition, the misuse of
chlordane has the potential to result in environmental
contamination.
For these reasons the Agency believes that the statutory
standard for registration can be met only if these products
are restricted for use by Certified Applicators or persons
under their direct supervision, as defined above and in the
"Restricted-Use Pesticide" label provision prescribed in
Section IV.D. Several States have already restricted the
use of chlordane. By presenting two options for compliance
with the restricted use requirement for chlordane, it is
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EPA's intent to ensure that chlordane is commpetently applied:
either under the immediate, physical supervision of a Certified
Applicator who can direct the implementation of site-specific
precautions as appropriate (Option 1); or, if a Certified
Applicator is not physically present, each State-registered
technician working at the site will have demonstrated competence
to safely conduct termiticide applications, following completion
of a training course in termiticide application administered
by the State in which he or she is working (Option 2). The
two options are intended to offer States some administrative
discretion on regulating professional pest control operations
under their jurisdiction. At the same time, EPA believes
that either option will serve to upgrade competence among
users of chlordane. EPA believes that, where a Certified
Applicator is not physically present, formally trained
technicians are less likely to misuse or misapply chlordane.
The minimum training and registration criteria for State
programs, which are set forth in this Registration Standard,
are intended to ensure that all users of chlordane who are
not Certified Applicators have demonstrated competence in
all aspects of termiticide application ranging from
comprehension of the importance of label precautions to
practical knowledge of emergency procedures in the event
that an accident should occur.
3. In order to meet the statutory standard for continued registra-
tion, the Agency has determined that chlordane product labels
must be revised to provide specific chlordane disposal
procedures.
Rationale; Chlordane products are toxic when discarded, and
improper disposal of excess pesticide, spray mixture, or
rinsate may result in risks to human health and/or environmental
contamination. Chlordane is very highly toxic to fish and
freshwater invertebrates. It is therefore, imperative that
effluent containing chlordane not be improperly discharged
into surface waters or sewer systems.
4. In order to meet the statutory standard for continued registra-
tion, the Agency has determined that chlordane products must
bear fish and wildlife toxicity warnings.
Rationale; Labeling requirements are imposed since available
data indicate that chlordane is very highly toxic to fish,
freshwater invertebrates, and some avian species.
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5. A special monitoring study is required to evaluate whether
and to what extent surface water contamination may be resulting
from the use of chlordane as a termiticide.
Rationale: Chlordane is persistent in'the environment and
can bxoaccumulate in fish and fresh-water invertebrates.
Human dietary exposure to chlordane may occur through
consumption of contaminated drinking water and tish. In
addition, chlordane is potentially very highly toxic to fish
and freshwater invertebrates. Chlordane has been found in
fish at levels in excess of the FDA action level at various
urban aquatic sites in Iowa, Missouri and Nebraska. Prelim-
inary evidence indicates that the source of contamination
may be a result of the termiticidal use of chlordane. The
Agency is, therefore, requiring a study in which sump pump,
drainage tiles, and sanitary sewer water, draining from home
foundations known to have been properly treated with chlordane,
are sampled for chlordane residues. Based on the results of
this study, additional regulatory action may be warranted.
6. The Agency is requiring the submission of applicator exposure
data from dermal and respiratory routes of exposure.
Rationale: Additional data are needed to determine whether
exposure to applicators during application of chlordane
products may be posing significant health risks. Registrants
are referred to Subdivision U of the Pesticide Assessment
Guidelines for acceptable exposure monitoring methodology.
This Guideline document is publicly available through the
National Technical Information Service (NTIS), Springfield,
Virginia 22161 (telephone: 703-487-4650). Registrants must
submit appropriate protocols for these exposure studies
within 90 days.
7. In order to meet the statutory standard tor continued registra-
tion the Agency has determined that the existing use directions
under the current termiticide LIP for chlordane product
labels must be clarified in order to further minimize human
exposure and avoid contamination of the environment.
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Rationale; Under the current termiticide LIP questions
have been raised regarding existing use directions pertaining
to soil treatment. Information indicates that certain
treatment procedures need clarification to accommodate
technical and safety aspects of termite control and
minimize exposure to homeowners and applicators. Such
revisions and precautions make the treatment instructions
more clear, minimize miapplication and ensure compliance.
8. In order to meet the statutory standard for continued
registration the Agency has determined that chlordane product
labels must contain a prohibition against application to plenum
houses (houses where the crawlspace beneath the building is
used to circulate heated or cooled air without ductwork).
Rationale; This restriction is necessary to guard against
potentially high levels of exposure. Information indicates that
application to these houses can result in very high indoor
air levels.
9. Special product-specific two-week inhalation testing is
required to evaluate the respiratory hazards to humans in
structures treated with termiticide products containing
chlordane.
Rationale: The Agency has received reports from individuals
complaining of upper respiratory problems associated with
termiticidal application of chlordane. To investigate
the extent of the problem, the Agency is requiring testing
to determine the potential of chlordane itself, the
formulation solvent(s), or the chlordane/solvent combin-
ation to cause irritation of mucous membranes. Pending
the results of this testing, additional regulatory measures
may be appropriate.
10. Examination of eye tissue from the RIASBT rat oncogenicity
study is required to evaluate the potential for chlordane
to cause optic neuritis in humans as a result of termiticide
treatment of homes.
Rationale; The Agency was recently apprised of three reported
cases of optic neuritis in humans associated with termiticida.l
application of chlordane. To determine whether this health
effect is significant, the registrant must have eye tissue
from the 1983 Research Institute for Animal Science
in Biochemistry and Toxicology (RIASBT) rat oncogenicity
study analyzed by neuropathologists specializing in
optic tissue pathology.
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11. Special indoor air monitoring studies are required to
support chlordane's use on structural wood (above ground)
and perimeter surface treatment in human dwellings for
termite control.
Rationale; In 1984, the Agency issued a Data Call-in
Notice to registrants of products containing chlordane
requiring a monitoring study of chlordane air levels in
homes of various construction types treated with chlordane
for subterranean termite control. The requirement was imposed
to provide data to estimate human exposure and to assess
the risks to humans associated with soil treatment use of
chlordane. A study is currently underway to fulfill this
requirement. The Agency is also concerned over the potential
health risks posed by the use of chlordane above ground
on structural wood (i.e. sills, joists, headers, plates,
cuts or studs and other structural members used in the
framing of a house) and perimeter surface treatment
in human dwellings (special local need registration). For
this reason, the Agency is requiring indoor air monitoring
of dwellings treated in accordance with current label
restrictions to support these unique use patterns.
12. While data gaps are being filled, currently registered
manufacturing-use products (MPs) and end-use products (EPs)
containing chlordane may be sold, distributed, formulated,
and used, subject to the terms and conditions specified
in this Standard. Registrants must provide or agree to
develop additional data, as specified in the Data Appendices,
in order to maintain existing registrations.
Rationale; Under FIFRA, the Agency may elect not to cancel
or withhold registration even though data are missing or
are inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7)).
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
actions are necessary.
13. The Agency has identified certain data that will receive
priority review when submitted to the Agency.
Rationale; Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may
trigger the need for further studies which should be
initiated as soon as possible. The following studies
have been identified to receive priority review as soon
as they are received by the Agency:
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§158.135 Toxicology
82-4 Subchronic Inhalation- Rats (one-year)
- Rats or Guinea-pigs (two-weeks)
83-1 Chronic Toxicity- Rodent and non-rodent
83-3 Teratogenicity- Rat and rabbit
83-4 Reproduction- Rat
84-2,
3,4 Mutagenicity
Special Test for optic neuritis
§158.125 Environmental Fate
161-1 Hydrolysis
161-2 Photodegradation in Water
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching and Adsorption/Desorption
164-2 Soil Dissipation
Surface Water Monitoring Study
Applicator Exposure Studies
Indoor Air Monitoring Studies
§158.120 Product Chemistry
all requirements
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B. CRITERIA FOR REGISTRATION
This Standard covers both manufacturing-use products (MPs)
and end-use products (EPs) containing chlordane4. Registrants
of chlorda.ne products must comply with all terms and conditions
described in this section/ including submission of an up-to-date
Confidential Statement of Formula, submission of revised
labeling, commitment to fill data gaps on the schedule specified
by the Agency and, when applicable, offer to pay compensation
as" required by 3(c)(l)(D) and 3(c)(2)(D) of the FIFRA.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard - Each product proposed for
registration or reregistration must be fully described with
an appropriate certification of limits, stating maximum and
minimum amounts of the active and intentionally added inert
ingredients which will be present in the product. The active
ingredient in any new product must be substantially similar
to that in currently registered chlordane products.
2. Acute Toxicity Limits - The Agency will consider registration
of any product in any Toxicity Category provided the product
labeling bears appropriate precautionary statements.
3. Use Patterns - Manufacturing-use products containing
chlordane must be labeled for formulation into end-use
products only for subterranean termite control and above
ground wood preservative treatment for the control of wood-
destroying insects, including termites. The EPA Compendium
of Acceptable Uses, Appendix III, lists the approved application
rates and methods of application.
The Agency considers all currently registered end-use products
containing chlordane in combination with solvents or diluents
to be sole active ingredient formulations. The Agency does
not consider solvents or diluents to be insecticidal and
therefore, must be declared as inert ingredients.
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D. REQUIRED LABELING
All manufacturing-use products (including formulation interme-
diates) and end-use products must bear appropriate labeling
as specified in 40 CFR 162.10, PR Notices 83-2 and 83-3, and
as indicated in this Registration Standard (as appropriate).
No end— use or manufacturing-use product containing chlordane may
be released for shipment by a registrant or producer of that
product 12 months after the registrant's or producer's receipt
of this Registration Standard, unless the product bears an
EPA-approved amended label which complies with this Registration
Standard.
No end-use .or manufacturing -use product containing chlordane may be
distributed, 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 24 months
after issuance of this Registration Standard, unless the product
bears an EPA-approved amended label which complies with this
Registration Standard.
1. All Products - All products must bear appropriate labeling
as specified in 40 CFR 162.10. Appendix II contains information
on labeling requirements. The following pesticide disposal
statement must appear on all labels:
"Pesticide wastes are toxic. Imprcoer 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 reoresentative at the nearest EPA Regional Office for
guidance. "
2. Manufacturing-use Products - All nanuf acturing-use products
must bear the following statements:
"For formulation into end-use insecticide products intended
only for subterranean termiticide use and above-ground
use on structural wood to control termites and other wood-
destroying insects."
"This pesticide is toxic to fish and wildlife. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public waters unless this product is
specifically identified and addressed in an NPDES permit. Do
not discharge effluent containing this product to sewer systems
without previously notifying the sewage treatment plant
36
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authority. For guidance contact your State Water Board or
Regional office of the EPA."
"The use of this product may be hazardous to your health.
This product contains chlordane, which has been determined to
cause cancer and adverse liver effects in laboratory
animals."
"Mixer/loaders must wear goggles or a face shield, chemical-
resistant apron, long-sleeved shirt and long pants, or
coveralls, and unlined, mid-forearm to elbow length chemical-
resistant gloves when mixing, loading, or otherwise handling
concentrate."
3. End-use Products - Labels for all end-use products
must bear the following statements:
"RESTRICTED-USE PESTICIDE
The use of this product may be hazardous to your health.
This product contains chlordane, which has been determined
to cause cancer and adverse liver effects in laboratory
animals. This pesticide persists in the environment and
bioaccumulates in living organisms. Risks can be reduced
by closely following all use directions and precautions,
and by wearing the protective clothing specified elsewhere
on this label. Treated buildings may be contaminated,
resulting in hazards to the health of occupants if this
product is not properly applied and used only for the
purpose stated on the label.
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 certifi-
cation. For the purposes of this product, direct super-
vision of a Certified Applicator means either: 1) the
actual physical presence of the Certified Applicator at
the application site during application, or 2) if the
Certified Applicator is not physically present at the
site, each uncertified applicator acting under instructions
and control of the Certified Applicator who is available
if and when needed, must have completed a State approved
training course which meets EPA minimal requirements
in termiticide application and must be registered for
termiticide application in the State in which the
uncertified applicator is working."
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'This pesticide is toxic to fish and wildlife. Do not apply
directly to water. Do not contaminate water by cleaning
of equipment or disposal of waste."
"Applicators must wear water resistant hat, lightweight
protective suit or coveralls, unlined chemical-resistant
gloves (natural rubber, neoprene, or polyethylene), and
unlined lightweight boots. MSHA/OSHA approved respirators
are required for applications in enclosed areas such as
crawl spaces. Mixer/loaders must wear goggles or a
face shield, chemical-resistant apron, long-sleeved shirt
long pants, or coveralls, and unlined, mid-forearm to
"elbow length chemical-resistant gloves when mixing,
loading, or otherwise handling the concentrate."
"Do not apply chlordane in or around poultry houses, barns,
silos, milk houses, or other structures or enclosures where
livestock or poultry is held, or where food/feed is stored,
prepared or processed."
"Do not apply chlordane to plenum houses (houses where the
crawlspace beneath the building is used to circulate heated
or cooled air without ductwork)."
4. Labels for all end-use products bearing directions for
subterranean termite control must be revised to include
the following (Note: each revision/change to the curent
LIP use directions are highlighted for easy reference):
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GENERAL INFORMATION ON THE USE OF THIS PRODUCT
Chemicals for soil treatment are used to establish a barrier
against termites. The chemical emulsion must be adequately
dispersed in the soil to provide a barrier between the wood in
the structure and the termite colonies in the soil.
It is necessary for the effective use of this product that the
service technician be familiar with current control practices
including trenching, rodding, subslab injection and low-pressure
applications. These techniques must be correctly employed to
prevent or control infestations by subterranean termites such as
Reticulitermes, Zootermopsis, Heterotermes, and Coptotermes.
Choice of appropriate procedures should include consideration of
such variable factors as the design of the structure, existence
of air circulation in subfloor crawlspace, watertable, soil
type, soil compaction, grade conditions, and the location and
type of domestic water supplies and drainage systems. The biology
and behavior of the termite species involved are important factors
to be known, as well as suspected location of the colony and
severity of the infestation within the structure to be protected.
All nonessential wood and cellulose-containing materials, including
scrap wood and form boards, should be removed from around foundation
walls, crawlspaces, and porches. Effective termite control also
includes elimination of termite access to moisture by recommending
repair of faulty construction, grade, and/or plumbing.
For advice concerning current control practices with relation to
the specific local conditions, consult resources in structural
pest control and the State regulatory agency.
SUBTERRANEAN TERMITE CONTROL
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner
inconsistent with its labeling. This product may not be used
against any pests not named on the label. Apply only to establish
subsurface termite control barriers specified on product labeling.
Contamination of public and private water supplies must be avoided
by following these precautions: Use antibackflow equipment or
procedures to prevent siphonage of pesticide back into water
supplies. Do not treat soil beneath structures that contain
cisterns or wells. Do not treat soil that is water saturated or
frozen. Consult State and local specifications for recommended
distances of treatment areas from wells, if no state or local
government recommendations are available, refer to Federal Bousing
Administration specifications for further guidance.
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PRECONSTRUCTION SUBTERRANEAN TERMITE TREATMENT
I «^^^l^_^_^_«.
Effective preconstruction subterranean termite control requires
the establishment of an unbroken vertical and/or horizontal
chemical barrier between wood in the structure and the potential
or existing termite colonies in the soil. To meet FHA termite-
proofing requirements, follow the latest edition of the Housing
and Urban Development (HUD) Minimum Property Standards.
Use a water emulsion for subterranean termites. Mix
gallon of (product name) in gallons of water to produce a
water emulsion.
Do not apply to any area intended as a plenum airspace. Check
with the builder or contractor to determine if the design of the
structure includes a plenum airspace.
HORIZONTAL BARRIERS
Before footings are poured, horizontal barriers may be established
in footing trenches. Then, after interior grading is completed
and prior to the pouring of concrete slabs, horizontal barriers
may be established on soil that will be covered by floors, entrance
platforms, or porches, and in other critical areas that will be
covered by construction. To produce a horizontal barrier, apply
the emulsion at the rate of 1 gallon per 10 square feet to fill
dirt. If fill is washed gravel or other coarse material.- apply
at 1 1/2 gallons per 10 square feet.
- It is important that the emulsion reaches the soil.
- Applications shall be made with low pressure (less than
50 psi at the nozzle) using a coarse-spray nozzle when
establishing horizontal barriers.
- If concrete slabs cannot be poured over soil the same day
it has been treated, a waterproof cover such as polyethylene
sheeting should be placed over the soil to prevent erosion.
This is not necessary if foundation walls have been installed
around the treated soil.
VERTICAL BARRIERS
After the foundation walls have been poured or built, vertical
barriers may be established around the perimeters of floating or
supported slabs, around utilities penetrating the slab, and in
other critical areas. After the final exterior grading is
completed, vertical barriers may be created in back-filled soil
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against foundation walls. To produce a vertical barrier, apply
the emulsion at the rate of 4 gallons per 10 linear feet per foot
of depth from grade to the top of the footing.
- Rodding and/or trenching applications should not be made
below the top of the footing except when the footing is
exposed at or above grade. Special care should be taken
to avoid soil washout around the footing.
- Trenches need not be wider than 6 inches.
- When rodding, it is important that emulsion reaches the
footing. Rodholes should be spaced to provide a continuous
barrier.
- Emulsion should be mixed with the soil as it is being
replaced in the trench. Cover treated soil with a layer
of untreated soil.
HOLLOW MASONRY UNITS OF FOUNDATION HALLS
In preconstruction situations in which application is not made to
soil prior to pouring the footing, treatment may be made through
masonry voids to establish a continuous chemical barrier at the
top of the footing. Apply at the rate of 2 gallons of emulsion
per 10 linear feet of footing.
Do not treat in this manner through voids in walls constructed on
interior slabs such as basement floors.
CRAWLSPACES
For crawlspaces, vertical barriers may be established using a
rate of 4 gallons of emulsion per 10 linear feet per foot of
depth from grade to the top of the footing. Application may be
made by rodding and/or trenching to the footing, if the footing
is exposed at or above grade, application should be made with
special care to avoid washout around the footing. Treatment
should include both sides of foundation and around all piers and
pipes extending from the soil. To avoid volatilization into air
within the structure, do not make an overall broadcast application
to areas intended to be crawlspaces; apply by rodding and/or
trenching.
- Rodholes should be spaced to provide a continuous chemical
barrier.
- Trenches need not be wider than 6 inches nor below the
footing. The emulsion should be mixed with the soil as it
is being replaced in the trench. Cover the treated soil
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with a layer of untreated soil. Moisture barriers such as
polyethylene sheeting may be used in addition to the
untreated soils.
MONOLITHIC SLABS
In the case of a single-pour monolithic slab that does not have
a separate foundation or footing, an overall horizontal barrier
should be created before the concrete is poured using a rate of
1 gallon of emulsion per 10 square feet. If fill is washed
gravel or other coarse material, apply at the rate of 1 1/2
gallons per 10 square feet. Critical areas beneath the slab such
as utility pipe entries may be treated at the rate of 4 gallons
per 10 linear feet around the pipe.
Exterior vertical barriers should be created after the concrete
has been poured and final grade established. Apply the emulsion
at the rate of 4 gallons per 10 linear feet per foot of depth to
the bottom of the concrete.
POSTCONSTRUCTION TREATMENTS
Use a water emulsion for subterranean termites. Mix
gallon of (product name) in gallons of water to produce
a water emulsion.
Postconstruction applications may be made by injection, rodding
and/or trenching with pressures less than 25 psi at the nozzle.
To avoid volatilization into the air within the structure, do not
make an overall broadcast application of this product in a crawl-
space. Rodholes or trenches should not extend below the footing
because of the possibility of soil washout by the emulsion.
Do not apply this product to the soil beneath a plenum airspace.
Do not apply emulsion until location of heat or air conditioning
ducts, vents, water and sewer lines, and electrical conduits are
known and identified. Do not apply this product to soil beneath
slabs with subslab or intraslab ducting until ducts are permanently
plugged. Surface application is prohibited, (italics)
CONCRETE SLABS
Vertical barriers may be established by subslab injection inside
and rodding and/or trenching outside at the rate of 4 gallons of
emulsion per 10 linear feet. Injectors should not extend beyond
the tops of the footings.
Treat along the outside of the foundation and where necessary
just beneath the slab on the inside of foundation walls. Treatment
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may also be required just beneath the slab along both sides of
interior footing-supported walls, one side of interior partitions,
and along cracks and expansion joints. Horizontal barriers may
be established where necessary by long redding or by a grid
pattern injection using a rate of 1 to 1 1/2 gallons of emulsion
per 10 square feet depending on fill type and condition.
- Drill holes in the slab about 12 to 36 inches apart to
provide a continuous chemical barrier.
. - Where necessary, drill through the foundation walls from
the outside and inject the emulsion just beneath the slab
either along the inside of the foundation or along cracks,
expansion joints, and other critical areas.
- For shallow foundations 1 foot or less, dig a narrow
trench approximately 6 inches wide along the outside of
the foundation walls. Do not trench below the bottom of
the foundation. The emulsion should be applied to the
trench and the soil at 4 gallons per 10 linear feet as the
soil is replaced in the trench. Cover the treated soil
with a layer of untreated soil.
- For foundations deeper than 1 foot follow rates for
basements.
HOLLOW MASONRY UNITS OF FOUNDATION WALLS
Treatment may be made through masonry voids to establish a
continuous chemical barrier at the top of the footing. Apply at
the rate of 2 gallons of emulsion per 10 linear feet of footing.
Where this treatment is necessary, access holes must be drilled
below the sill plate and should be through a lower mortar joint.
Before treatment through basement walls, seal the interior wall
and floor expansion joint with mortar, caulk, waterproofing
material, or similar impervious sealant. Also, seal openings at
the top of the foundation wall. Do not treat in this manner
through voids in walls constructed on interior slabs such as
basement floors.
BASEMENTS
For basements and slab foundations that extend more than 1 foot
below grade, vertical barriers may be applied at a rate of 4
gallons of emulsion per 10 linear feet per foot of depth from
grade to the top of the footing. Treat the outside of the founda-
tion by trenching and/or rodding. Subslab injection may be
necessary along the inside of foundation walls, along cracks,
along partitions, around sewer pipes, conduits, and piers, and
along both sides of interior footing-supported walls.
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CRAWLSPACES
In crawlspaces, vertical barriers may be applied at the rate of
4 gallons of emulsion per 10 linear feet per foot of depth from
grade to top of footing. Application may be made by rodding
and/or trenching.
Do aot apply this product to the soil beneath a plenum airspace.
To avoid volatilization into air within the structure, do not make
an overall broadcast application of this product in a crawlspace:
apply by rodding and/or trenching. Rodholes or trenches should
not extend below the footing. Treat both sides of foundation and
around all piers and pipes.
- Rodholes should be spaced to provide a continuous chemical
barrier.
- Trenches need not be wider than 6 inches nor below the
footing. The emulsion should be mixed with the soil as it
is replaced in the trench. Cover the treated soil with a
layer of untreated soil. Moisture barriers such as
polyethylene sheeting may be used in addition to the
untreated soil.
- If it is necessary to make an overall barrier under soil
in a crawlspace, this treatment may only be made by
injecting the emulsion several inches below the soil
surface.
- It should be recommended that inadequately ventilated
crawlspaces be brought into compliance with FHA Minimum
Property Standards specifying 1 square foot of ventilator
opening per 150 square feet of crawlspace area.
EXCAVATION TECHNIQUE
If treatment must be made in difficult situations such as near wells
or cisterns, along faulty foundation walls, and around pipes and
utility lines which lead downward from the structure, application
may be made in the following manner:
- Trench and remove the soil to be treated onto heavy plastic
sheeting or similar liner.
- Treat the soil at the rate of 4 gallons of emulsion per
10 linear feet per foot of depth of the trench. Mix the
emulsion thoroughly into the soil taking care to prevent
liquid from running off the liner.
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- After the treated soil has dried adguately, replace the
soil in the trench and cover with a layer of untreated
soil.
Prior to using this technique near wells or cisterns, consult
State, local, or Federal regulatory agencies for information
regarding approved treatment practices in your area.
AFTER TREATMENT
Before leaving the job site, securely plug all holes drilled in
construction elements of commonly occupied areas of structures,
including unfinished basements, enclosed porches, garages, and
workshops.
RETREATMENT
Retreatment for subterranean termites should only be made when
there is evidence of reinfestation subsequent to the initial
treatment, or there has been a disruption of the chemical barrier
in the soil due to construction, excavation, landscaping, etc.
Retreatment should be made as a spot application to these areas.
Retreatments may be made to critical areas in accordance with the
application techniques described above. This application should
be made as a spot treatment to these areas. Routine retreatment
of the entire premises should be avoided.
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II. LABELING APPENDICES
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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 ingredi-ent 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 B.2
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.
B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A and labeling
requirements specified for manufacturing use products in
Section IV.
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.
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C. End use products containing this pesticide as the
sole active ingredient* are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the femulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the femulator'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.
solvents or diluents must be declared as inerts. The
Agency does not have data indicating that these solvents are
insecticidal.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the femulator'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.
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The labeling requirements specified for end use
products specified in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
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.
4 Registrations granted after issuance of this Standard
will be conditioned upon submission or citation of the data
listed in this Registration Standard.
49
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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 iff at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's 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 comply with the OCI 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.
50
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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 name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data.
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.
-------
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
protocols.
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,
52
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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 timeframe
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.
-------
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.
54
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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.
55
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IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing Chlordane
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
b. Confidential Statement of Formula (EPA Form 8570-4),
attached separately.
c. Formulator's Exemption Statement/ 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 submit to the Product Manager:
a. Two copies of any required product-specific data
(See Table B).
b. Five (5) 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 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.
c. Product Specific Data Report.
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.)
56
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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 Chlordane 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
attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4),
attached separately.
c. Formulator's Exemption Statement, if applicable.
2. Within 9 months from receipt of this document you must
submit five (5) copies of draft labeling.
3. 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 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.
C. End Use Products containing Chlordane alone6/ or 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 Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4),
attached separately.
c. Formulator's Exemption Statement, 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.
The Agency considers all currently registered end-use products
to be sole active ingredient formulations. The Agency does not
consider solvents or diluents to be insecticidal, and therefore,
must be declared as inerts.
57
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b. Product Specific Data Report, if Table C lists
required product-specific data.
c. Five 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).
E. Addresses
The required information must be submitted to the following
address:
George LaRocca
Product Manager 15
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental 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 of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
58
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I. DATA APPENDICES
59
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
•apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
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
PAL = 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.
60
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TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates 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
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional 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.
61
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TABLE: A
GENERIC DATA REQUIREMENTS FOR CHLORDANE
Data Requirement
Test
Substance
Use Does
Patterns Have
EPA Bibliographic
Data?1/ Citation V
Must Additional Timeframe
Data be for
Submitted? Submission2/
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and Dis- TGAI
closure of Ingredients
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI
62-2 - Certification of Limits TGAI
62-3 - Analytical Methods to Verify TGAI
Certified Limit
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
H,I
H,I
Yes
Yes
Yes
6 Months
6 Months
6 Months
Yes
Yes
Yes
Yes
Yes
Yes
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
62
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORQANE
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?V Citation V 'Data be for
I Submitted? Submission^/
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
(continued)
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 - Octanol/Vtater Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements;
64-1 - Subnittal of Samples
TGAI 11,1
TGAI 11,1
TGAI H,I
TGAI or PAI 11,1
PAI 11,1
PAI H,I
PAI H,I
TGAI H,I
TGAI H,I
TGAI, PAI 11,1
Yes
NoV
Yes
Yes
NoV
Yes
Yes
Yes
Yes
ReservedV
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
(8 Months - Progress
Report)
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been introduced and previously submitted
data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
3/ Not required since chlordane is a solid at roan temperature.
4/ Not required because the melting point of the pure form of the active ingredient is >30° C.
5/ It samples are needed, the Agency will request them.
63
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDANE
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional
Citation Data be
. Submitted?
Timeframe
for
Submission1/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodeqradat ion
161-2 - In Water
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:
TGAI or PAIRA II
TGAI or PAIRA H
TGAI or PAIRA N/A
TGAI or PAIRA N/A
TGAI or PAIRA H
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
163-1 - Leaching and TGAI or PAIRA
Adsorpt ion/Desorpt ion
H
II
H
H
No
No
No
No
No
No
No
Yes
YesV
9 Months
9 Months
Yes
YesV
ReservedV
YesV
Yes
27 Months2/
(8 Months - Progress
Report)
27 Months^
(8 Months - Progress
Report)
27 Months
(8 Months - Progress
Report)
12 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDANE
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance • Patterns Have Data? Citation Data be for
Submitted? Submission1/
§158.130 Environmental Fate (continued)
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
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
TEP
TEP
TEP
TEP
PAIRA
TEP
N/A
N/A
H
TEP
TEP
II
N/A
N/A
N/A
N/A
N/A
TEP N/A
TGAI or PAIRA II
No
No
Yes
ReservedV
27 Months2/
(8 Months- Progress
Report)
No
ReservedV
65
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDANE
Data Requirement
Test
Substance
Use
Pattern
Does EPA Have
Data?
Bibliographic
Citation
Must Additional
Data be Submitted?
Timeframe
for
Submission1/
§158.130 Environmental Fate (continued)
165-5 - In Aquatic Nontarget TEP
Organisms
MONITORING STUDIES:
Hater Monitoring Study
EXPOSURE STUDIES:
Applicators
Residents- Indoor Air
Monitoring Study-
Velsicol's Ongoing Study
TEP
N/A
Hfl
No
TEP
TEP
No
No
YesV 15 Months
(90 Days- Acceptable
Protocol)
(8 Months- Progress
Report)
YesV 6 Months
(90 Days- Acceptable
Protocol)
Yes£/ (Final Report-
February, 1986 )
Residents- Indoor Air
Monitoring Study-
Above Ground Use in Structural Wood
TEP
No
YesV8/ 24 Months
(90 Days- Acceptable
Protocol)
(8 Months- Progress
Report)
I/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ The first progress report is due 8 months after receipt of this Standard. Interim reports are due semi-annually
thereafter.
3/ Because of the detection of residues of chlordane in urban water systems, presumably from termiticide uses, addition-
al data requirements have been imposed, which will focus on the fate of chlordane in the aquatic environment.
These are: photodegradation in water, anaerobic soil metabolism and aerobic aquatic metabolism. Aquatic (sediment)
dissipation and aerobic aquatic metabolism data requirements are reserved pending the results of the aerobic aquatic
metabolism study. Ffish residue accumulation data are reserved pending the results of the octanol/water partition
coefficient studies.
66
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHLURDANE
§158.130 Envirormental fate (continued)
4/ A special monitocing study is required, either prospective or retrospective; in which water from sanitary sewers,
sumps, and drainage tiles, draining from home foundations treated with chlordane, is sampled and analyzed
toe residues of chlordane. An acceptable protocol must be submitted within 90 days of receipt of this Standard.
5/ Applicator exposure data must be submitted to support chlordane's termiticide uses. Acceptable proptocols must be
submitted within 90 days of receipt of this Standard.
6/ This requirement was originally imposed as part of the Agency's 1984 Termiticide Data Call-In program. This study is
currently in progress. Further testing may be required pending the results of this study.
T/ A one-year indoor air monitoring study is required to support registration or products registered tor above ground
use in structural wood. The study must be conducted in homes of various construction types, treated in accordance
with label directions.
8/ The first progress report is due 8 months atter receipt of this standard. Interim reports are due semi-annuaily
thereafter.
67
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TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDANE
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data be tor
Submitted? Submission*/
§158.135 Toxicology
ACUTE TESTING;
81-1 - Acute Oral Toxicity - Rat
TGAI B,H,I
NO
Yes
9 Months
81-2 - Acute Dermal Toxicity -
Rabbit
TGAI B,H,I
81-7 - Delayed Neurotoxicity - Hen TGAI B,H,I
No
81-3 - Acute Inhalation Toxicity - TGAI B,H,I No
Rat
No
Yes
Yes
No2/
9 Months
9 Months
SUBCHRDNIC TESTING;
82-1 - 90-Day Feeding: Rodent
and Nonrodent (Dog)
TGAI B,H,I Partially
GS0173-002
82-2 - 21-Day Dermal - Rabbit
82-3 - 90-Day Dermal - Rabbit
82-4 - 90-Day Inhalation - Rat
82-5 - 90-Day Neurotoxicity
1GAI
TGAI
TEP
TGAI
B,H,I
B,H,I
B,H,I
B,H,I
NO
No
NO
NO
ReservedV
NoV
68
-------
TABLE A
GENERIC DATA REQUIREMENTS FUR CHLORDANE
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional Timeframe
Citation .Data be for
Submitted? Submission1/
§158.135 Toxicology (continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity -
Rodent and Non-Rodent
83-2 - Oncoyenicity -
Mouse
Rat
TGAI
1GAI
1GAI
B,H,I
B,H,I
B,H,I
No
Yes
Yes
GS0173-004
GS0173-004
YesV
NO
No
bU Months^/
(8 Months- Progress
Report)
83-3 - Teratogenicity -
Rat and Rabbit
83-4 - Reproduction - Rat
2-generation
MUTAGENICITY TESTING;
84-2 - Gene Mutation
84-3 - Structural Chromosomal
Aberration
84-4 - Other Genotoxic Effects
TGAI B,H,I
TGAI B,H,I
TGAI B,H,I
B,H,I
TGAI B,H,I
NO
No
Partially GS0173-007
Partially 00123771
Partially 00109564
Yes
Yes
Yes8/ll/
Yes*/11/
Ib Months
(8 Months- Progress
Report)
39 Monthsl2/
(8 Months- Progress
Report)
9 Months
12 Months
Yes WAI/ 12 Months
(90 Days- Acceptable
Protocol)
69
-------
TABLE A
GENERIC DATA REQUIREMENTS UUR CHLDRDANE
Data Requirement
Test Use Does EPA bibliographic Must Additional Time frame
Substance Patterns Have Data? Citation Data be toe
Submitted? Submission9/
85-1 - General Metabolism
SPECIAL TESTING;
Optic Tissue Pathology
Rat Inhalation Study
PAI or PAIRA
Yes
No
No
GSO173-006
NcW
YeslV
Yes*/
To be Determined
24 Months
\/ Due dates refer to the number of months following receipt of the Registration Standard by the registrant, unless
otherwise indicated.
2/ Chlordane is dissimilar to known delayed neutrotoxic agents (i.e., organophosphates) and neurotoxicity ot the delayed
type has not been reported in the large number ot chemical plant intoxications encountered. Recovery has been com-
plete and relatively rapid when humans were removed from the exposure area. For these reasons, the Agency is not
requiring this test.
V The Agency has an acceptable subchronic rodent study on file. The Agency is not requiring a 9U-day study using non-
rodents, since long-term studies supercede the need for subchronic studies.
4/ Requirement for submission of a 21-day dermal study is reserved pending the results ot the acute dermal
toxicity study.
5/ The Agency recognizes that chlordane is absorbed dermally and toxicity can ensure from that exposure. However, the
target organs have been well delineated from other routes of exposure and therefore, no data are required for
this area of study.
6/ A requirement tor a 90-day subchronic inhalation study was originally imposed as part ot the Agency's 1984 Dat
Call-in Notice. The study submitted to the Agency is invalid since the lowest dose tested was higher than the NAS
guideline as requested in the DCI. A new rat inhalation study must be performed tor a period ot one year, rather
than 90-days, as this exposure period more likely reflects typical human exposure resulting from termiticide use.
The registrant must also use the NAS guideline level for the lowest dose level.
70
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TABLE A .
GENERIC DATA REQUIREMENTS fOR CHLORDANE
§158.135 Toxicology (continued)
7/ Data yaps exist toe chronic feeding testing in rodents and non-rodents.
8/ Gene mutation assays in mammalian cell systems with and without metabolic activation are required.
9/ In vivo mammalian assays for chromosome aberrations in somatic cells (e.g., rodent bone marrow)
are required.
10/ The following studies are required:
a. assays tor sister chrcmatid exchange in mammalian systems.
b. ^n vitro assays for SCE (with and without activation) in mainnaiian cell systems.
c. ^n vitr o transformation with promotion assay.
d. in vivo promoting activity assay.
ll/ This requirement was originally imposed as part of the Agency's 1984 Special Termiticide Data Call-in Notice.
Data received in response to that DCI were reviewed in conjunction with the development of this
Registration Standard and found to be unacceptable or inconclusive (see footnotes 8,9, and 10).
12/ The first progress report is due 8 months after receipt ot this Standard. Interim reports are due semi-annually
thereafter.
13/ This requirement was originally imposed as part of the Agency's 1984 Special Termiticide Data Call-in Notice.
Acceptable data have been received by the Agency.
14/ Eye tissue from the NIAST 1983 rat oncogenicity study must be analyzed by neuropathologists specializing in
optic tissue pathology.
-------
TABLE A
GENERIC DATA REQUIREMENTS bOR CHLQRDANE
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional Time trams
Data be toe
Submitted? Submission*/
§158.145 Wildlife and Aquatic Organisms
AVIAN AND MAMMALIAN TESTING;
71-1 - Acute Avian Oral Toxicity TGAI
H.I
Yes
00107419
No
71-2 - Avian Subacute Dietary TGAI
Upland Game Bird and Waterfowl
Yes
001U7420
OOUU5950
00107419
No
71-3 - Wild Marnnal Toxicity
TGAI
N/A
71-4 - Avian Reproduction TGAI H,I
Upland Game Bird and Waterfowl
71-5 - Simulated Field Testing TEP H,I
and Actual Field Testing -
Mammals and Birds
72-1 - Freshwater Fish Toxicity
- Warmwater and Coldwater TGAI H,I
Species
Unique formulation TEP H,I
(Wannwater Species)
No
No
Yes
Yes
00103880
00103881
GS0144-012
00068575
00104015
00086221
00108085
Reserved2/
Reserved^/
No
No
72
-------
TABLE A
GENERIC DATA REQUIREMENTS tl>R CHLORDANE
Data
§158
Requi rement Test Use
Substance Patterns
.145 Wildlife and Aquatic Organisms (continued)
- Unique Formulation TEP H,I
(Cold water Species)
AQUATIC ORGANISM TESTING:
72-2
72-3
- Acute Toxicity to TGAI H,I
Freshwater Invertebrates
- Unique formulation TEP H,I
- Acute Toxicity to Estuarine TGAI H,I
and Marine Organisms
- Unique Formulation TEP H,I
Does EPA Bibliographic
Have Data? Citation
Yes 00060574
00104014
00086221
00103882
Yes DO 10 388 5
GSU144-012
Yes 00067012
00086221
NO
Yes 00068561
00104011
00086222
Must Additional
Data be
Submitted?
NO
No
No
ReservedV
Reserved2/
Timetrame
tor
Submission1
72-4 - Fish Early Lite Stage,
and Aquatic Invertebrate
Li lie Cycle
TGAI H,I
NO
Reserved^/
72-5 - Fish - Lite Cycle
72-6 - Aquatic Organism
Accumulation
TGAI H,I No
TGAI, PAI or li,I No
Degradation
Product
Reserved^/
Reserved^/
73
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDANE
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
72-7 - Simulated field Testing
and Actual Field Testing
- Aquatic Organisms
IBP
§158.145 Wildlife and Aquatic Organisms
No
Reserved2/
SPECIAL TESTING
70-1 Aquatic Residue Monitoring
No
Reserved^/
Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
This requirement is reserved pending the results of the special monitoring study, in which water from sanitary sewer,
sumps, and drainage tiles, draining from home foundations treated with chlordane, is sampled and analyzed for residues
of chlordane.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHLORDANE
Data Requirement
Test
Substance
Use Does EPA Bibliographic Must Additional Timeframe
Patterns Have Data?!/ Citation */ Data be
Submitted?
tor
Submission2/
§158.120 Product Chemistry
Product Identity;
61-1 - Product Identity and
Disclosure of
Ingredients
61-2 - Description of Beginning
Materials and
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 Methods to Verify
Certified Limit
63-3 - Physical State
6J-4 - Odor
MP V H, I
MP
MP
MP
MP
MP
Physical And Chemical Characteristics;
63-2 - Color MP
MP
Yes
Yes
Yes
Yes
Yes
Yes
MP
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
75
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHLORDANE
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?_V Citation V Data be for
Submitted? Submission?/
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
(continued)
63-7 - Density, Bulk Density, or MP H.I
Specific Gravity
63-12 - pH MP H.I
63-14 - Oxidizing or Reducing MP H.I
Action
63-15 - Flammability MP H,I
63-16 - Explodability MP H,I
63-17 - Storage Stability MP H.I
63-18 - Viscosity MP H.I
63-19 - Miscibility MP H.I
63-2U - Corrosion Characteristics MP H,I
Other Requirements:
64-1 - Submittal of MP H.I
Samples
Yes
Yes
Yes
Yes
Yes
7 Months
7 Months
7 Months
7 Months
7 Months
Yes 16 Months
(8 Months - Progress
Report)
Yes
Yes
Yes
ReservedV
7 Months
7 Months
7 Months
I/ Although product chemistry data may have been submitted io the past, the Agency has determined that these data mist
be resubmitted £or each manufacturing-use product. New requirements have been introduced andpreviously submitted
mii«;h hp nrvlat-rvl. Thprofnre. hihl inriranhir rifat-ions for |-h« old data are not applicable*. 76
-------
TABLE B
GENERIC DATA REQUIREMENTS FOR CHLORDANE
S 158.120 Product Chemistry (continued)
2/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
3/ Formulation intermediates are also included in the category of manufacturing-use products.
4/ If samples are needed, the Agency will request them.
77
-------
TABLE B
PRODUCT SPBCIflC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHLORDANE
Data Requirement Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional Timeframe
Data be tor
Submitted? Submission1/
ACUTE TESTING:
81-1 -
81-2 -
81-3 -
81-4 -
81-5 -
81-6 -
Acute Oral Toxic ity - Rat MP 2/ B,H,I No
Acute Dermal Toxicity MP V B,H,I No
- Rabbit
Acute inhalation Toxicity MP B,H,I No
- Rat
Primary Eye Irritation MP B,H,I No
- Rabbit
Primary Dermal irritation MP B,H,I Partially 00138591 ' i
- Rabbit " '
Dennal Sensitization MP B,H,I No
- Guinea Pig
Yes 9 Months
Yes 9 Months
Yes 9 Months
yes 9 Months
yesV 9 Months
NoV
I/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ Formulation intermediates are also included in the category of manufacturing-use products.
3^ Due to the extensive human exposure data compiled without reported detmal sensitization, testing is not required.
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS TOR END-USE PRODUCTS CONTAINING CHLORDANE
Guideline Citation and Name of Test Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?V Citation*/ Data be for
Submitted? Submission2/
§158.120 - Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure EP H,I
of Ingredients
61-2 - Description of Beginning Materials EP H,I
and Manufacturing Process
61-3 - Discussion of formation of EP H,I
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis EP H,I
62-1 - Certification of Limits EP H,I
62-3 - Analytical Methods to Verify EP H(I
Certified Limit
Physical and Chemical Characteristics
63-2 - Color EP H,I
63-3 - Physical State EP H,I
fa3-4 - Odor EP H,I
63-7 - Density, Bulk Density, or EP H,I
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 12 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Specific Gravity
79
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING CHLORDANE
Guideline Citation and Name of Test Test Use Does EPA Bibliographic Must Additional
Substance Patterns Have Data?J/ Citation?/ Data be
Submitted?
Timeframe
for
Submission^/
§158.120 - Product Chemistry (continued)
Physical and Chemical Characteristics
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
63-21 - Dielectric Breakdown Voltage
Other Requirements:
64-1 Submittal of Samples CP,TGAI
(continued)
EP H,I
BP H,I
EP H,I
EP H,I
EP 11,1
EP 11,1
EP H,I
EP H,I
EP H,I
,PAI H,I
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
NoV
Reserved^/
6 Months
6 Months
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data must
be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
y Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
3/ Not required since product labelling cautions to avoid use near electrical equipment.
4/ II samples are needed, the Agency will request them.
80
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING CHLORDANE
Guideline Citation and Name of Test Test
Substance
Use Does EPA Bibliographic Must Additional Timeframe
Patterns Have Data? Citation Data be for
Submitted? Submission1/
§158.135 Toxicology
Acute Testing;
81-1 - Acute Oral Toxicity - Rat EP H,I
81-2 - Acute Dermal Toxicity EP H,I
- Rabbit
81-3 - Acute Inhalation Toxicity EP H,I
- Rat
81-4 - Primary Eye Irritation EP H,I
- Rabbit
81-5 - Primary Dermal Irritation EP H,I
- Rabbit
81-6 - Dermal Sensitzation EP H,I
SPECIAL TEST
Guinea Pig or Rat
Inhalation Study EP H,I
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
No
Yes3/
15 Months
(90 Days- Acceptable
Protocol)
(8 Months- Progress
Report)
Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
Due to extensive human exposure data complied without reported dermal sensitization, testing is not required.
Testing is required to delineate the imitative capabilities to mucous membranes of chlordane, the solvent, and/or
the combination. The study design must include a 7-day exposure period to two groups of guinea pigs, with a
2-week recovery in one group; the seoopnd to be sacrificed after 7 days of exposure. Exposures should be for
6-8 hrs/day at levels found in a house on day 1 of termite treatment, and include end-use solvent alone; chlordane
alone, and solvent plus chlordane. Registrants of products containing the same or similar solvents are encouraged
to develop data jointly.
-------
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 ot 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)l
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)]
82
-------
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 7B. 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 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 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)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
83
-------
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.
-------
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)(l)(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 may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted 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.
85
-------
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
should be made part of the response to this notice and submitted
for review.
86
-------
SUMMARY-6
LABELING REQUIREMENTS OP THE PIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Iba.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg . No .
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
87
-------
SUMMARY-?
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category Is
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
Cor all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, SB, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
88
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP 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
PHVS/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."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
89
-------
PACCMJIKMAAV ITATEMENia
HAZARDS TO HUM AN*
ft DOMESTIC AMMAU
CAUTION
fMVnONUCMTAL HAZARD*
mVHCAL M CMUBAt
HAZARDS
M-CNmV (lATEUENI
CROP:
CHOP:
PRODUCT
NAME
ACIME MOHCOCHT: ,
MEftT MOMfOCNTt:,
IOTAL:
10040 «
1W9 PAOOUCf CONTAMS IM Of PKRQAUAN
KEEP OUT OF REACH OF CHILDREN
CAUTION
tTARUfHT OF MUCDGAL TMATUCMT
V MIVM
•Ef MM PANEL KM AOOmOMAL PMOAlinONAflV •TAIKUEHTt
TOWM. OTATI ..
EaiAILBHUENT NO.
Nil COHIENT1
STORAGE AND
DISPOSAL
•TOHAOI:
BMKMAL;
WAWUNIVnAIEUOa
9 0
-------
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
|t DOMESTC ANMAL8)
DANOER
ENVMONMENTAL HAZARDS
PHYSCALORCHIMttAl
HAZARDS
usi
• to •
RE-ENTRY STATEMENT
STORAGE AND
' DISPOSAL
OTQUAAt —
cuor.
RESTRICTED USE
PESTICIDE
(reason for clasr.Ifylnp)
«TAIL a^t 10 AMI IBC au.1 ti cutnnto un.ujaaa on
e UHEEM THCU OIRfCT 8UKRVU1CM MO ONLV fOR TKBC
awcRto »i me cnririco APVUCATDM'S
PRODUCT
NAME
ACTIVE MOREOCNT: ,
MEHT MOWMCNTS.,
TOTAL:
10000%
TMtt PRODUCT CONTAMS IBS OF PEROAU.ON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
STATIUfMT Of PRACTICAL TREATMENT
* SWALLOWED:
» WHAUEO =
r M EVES
SEI 8OC PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
urosr:
TOWN. STATE ==
ESTABLISHMENT NO. =
EPA REQISTHATION NO. i
NET CONTENTS:
WARRANTY STATEMENT
91
-------
(S40L 3. i. Ud 29 Of JTJTIA. u i
CTAC. LM «f M*J
,04 7K rrm Mv 11. l»T»l
IIIUO Uteiiaff nquinnwitt.
(M Cfowroi—(l> Ccnontt a/ tfU
Every peatteid* pmdueu sluil
Utai conuinuv me !aianB*»
(lea ip«ctiled br t&e Act ud Oit re«u-
Utiou -A tail Put. Tiie eanuau o< b
Utai CBUK mow cieviy aod pnmi*
a«acl7 me following:
(1) TJie QAfflt. anad. or ndem»rt
under vnica tat groduct ^ Mid u grg>
scribed la pencraea to) si taj* iec>
won:
(U) Tie aisie and addrea o< cae
preducar. mlatTvit. or person (or
whom produced u prescribed la pw»>
mob (o of tau Mcaon:
-------
11*1.10
tlv) The
number M pn
icgtotraUon
rlbed In paragraph
of this section:
(v» The producing establishment
number as prescribed In paragraph (I)
of thb section;
(vl) An Ingredient statement M pre-
scribed In paragraph (g) of Ihto eec-
Uon;
(vll) Warning or precautionary state-
ments ma prescribed In paragraph (h)
of thb section;
(«lll) The directions for use M pre-
•crlbed In paragraph (I) of Into section;
and
(Ix) The use classification's) M pre-
scribed In paragraph (j) of Ihto section.
All required label lent must:
(A» Be art In 0-polnt or larger type;
General
The label shall appear on or be secure-
ly attached to the Immediate contain-
er ol thr pesticide product. For pur-
poses of Ihto Section, and the mto-
brandlng provisions of the Ad, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the Im-
mediate container to enclosed within a
Tlrio 40—Protection of fnvlionmenl
wiapper or outside contalnrr through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer. If It to a part of the package as
customarily distributed or sold. •
(II) Tttnk can and other o«f* con- I
fafm>r«-(A) Transportation. While a !
pesticide product to In transit the ap- '
proprlate provisions of 4* CPU Parts |
IIO-lAf. concerning the tramiportatlon
of hamrdous materials, and spedtlcal- '
ly those provisions concerning the la- ,
bellng. marking and placarding of haz-
ardous materlato and the vehicles ear-
« rylng them, define the bank Federal
requirements. In addition, when any
regtolered prstldde product to trans-
ported In • tank car. tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
acts are stored In bulk containers.
whether mobile or stationary, which
remain hi the custody of the user, a
copy of the label of labeling. Including
all appropriate directions for use. shall
be securely attached to the container
In the Immediate vicinity of the dis-
charge control valve.
(ft) Fobs or mbfcodhtff statement*.
Pursuant to section 2(qMlMA) of the
Act. a pestldde or a device declared
subject to the Act pursuant to
I 102. IS. to mtabranded If IU labeling to
false or misleading In any particular
Including both pestlddal and non-pea-
tlddal claims. Examples of statements
or representations In the Isbellttg
which constitute mhbrandlng Include:
(I) A false or misleading statement
concerning the composition of the
product;
(II) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device:
(III) A fslse or misleading statement I
about the value of the product lor)
purposes other than as a prsltclde or
device: i
(Iv) A fslse or misleading comparison
with other pesticides or devices;
(v) Any statement directly or Indi-
rectly Implying that the pesticide or
device to recommenced or endorsed by
Cnwplor I—environmental Prelection Agency
9 lol.lo
any agency of the Federal Govern-
ment;
(vl) The name of a prslMdc which
contains two or more principal active
Ingredients If the name suxxcsls one
or more but not all such prlncliml
active Imrredlenls even though the
names of the other Ingredients are
slated elsewhere In the labeling;
(vll) A true statement used In such a
wsy as to nlve s false or mMlmdlnx Im-
pression to the purchaser;
(vlll) Imbcl disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions:
(Is) Claims as to the safety of the
pesticide or Us Ingredients. Including
statements such as "safe." "nnnpotoon-
ous." "nonlnjiirloiis." "harmless" or
"nontosk to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(•) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited U»-
(A) "Contains all natural Ingredi-
ents":
(B) "Among thr least tosk chemi-
cals known"
- (C) "Pollution approved"
<«> Final printed faoeflnv. (I) Except
as provided In paragraph (aM0Nll> of
this section, final printed labeling
must bo 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 labels such M those allk-
screrned directly onto glsss or metal
containers or Isrge bag or drum labels.
Such reproductions must be of mkro-
Illm reproduction quality.
(b) Name, brand, or trademark. (I)
The name, brand, or trademark under
whkh the pesticide product Is sold
shall appear on the front panel of the
label.
(21 No name, brand, or trademark
may appear on the label which:
(I) Is tahc or misleading, or
(II) Has not been spproved by the
Administrator through regliitrallon or
supplemental rcftl.itrnllon a* an addi-
tional nsme pursuant to I Ifll 6fh)(4).
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified nsme and sd-
dress given on thr label shall be con-
sidered as the nsme and addrem of the
producer. It the registrant's name ap-
pears on the label and the rcgMrattl to
not the producer, or If thr name of the
person for whom the pesticide was
produced appears on tlie label. It mii.it
be qualified by appropriate wording
such as "Packed for * * V "OMrlbul-
rd by • • V or "Bold by lo show
(hat the nsme Is not I hat of I he pro-
ducer.
Id) rVef Mvfpnf or mmsurr nl con-
tent* (I) The net weight or measure
of content shall be exclusive ol wrap-
pers or other materials and shall be
the avcraxe cnnlent unions rnpllrlllv
stated as a minimum quant It jr.
Ol If lite pesticide M a liquid. Ilir
net content statement Miall IN> In
terms of liquid measure at HIT F (WC)
and shall be expressed In ntnvriillnnal
American units of fluid ouncr*. plnla.
quarts, and gallons.
(3) If the pmllcldr la solid or semlan-
lid. viscous or prrssurlred. or H a mix-
ture of liquid and solid, the net con-
tent statement shall be In lermn of
weight expressed as avolrilnpol*
pounds and ounces.
(4) In all cases, net content shall be
stated In terms of the largest suitable
units. I.e.. "I pound 10 ounces" ml her
than "20 ounces."
(B) In addition to the required units
specified, nrt content may be ex-
pressed In metric units.
(0) Variation abnvr minimum eon-
tent or around an avetsgr Is permlwl-
ble only to the extent that It repre
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum H not permit
ted. In no case shall the averaxe con-
tent of the packages In a shipment lull
below the stated average content.
(e) Product rr^f if ration numfter
The registration number aligned lo
the pesticide product at the lime ol
registration shall appear on the label.
preceded by the phrase "RPA flcxfe
tratlon No.." or the phrosr "rrA Reg.
No." The registration number aliall be
set In type ol a sire and ulyle nlmllsr In
other print on that part nf the Inhcl
on which It apitear* an«l *hall run par
2R
93
-------
1141.10
allcl to It The registration number
and the required Identifying phrase
shall not appear In such a manner as
to suggest or Imply recommendation
or endonement of the product by ihe
Agency.
(f) Producing e*tabtl*hment» reals-
(ration number. Ttie producing estab-
lishment registration number preced-
ed by the phrase "EPA Esl.**. of Ihe
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package If the EPA establishment reg-
btratlon number on the Immediate
container cannot be clearly read
through such wrapper or container
(f) Ingredient statement—(I) Gener-
al The label ol each pesticide product
must bear a statement which contain*
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all Inert Ingredi-
ents; and If the pesticide contains ar-
senic In any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term "active Ingredi-
ents" and the Inert Ingredients by the
term "Inert Ingredients." or the singu-
lar forms of these terms when appro-
priate. Roth terms shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none** la
not required for pestkldes which con-
tain 100 percent active Ingredlenla,
Unless the Ingredient statement b a
complete analysis of the pesticide, the
term "analysis'* shall not be used as a
heading for the Ingredient statement.
<3) JtMlflon q/ Ingredient statement
(I) The Ingredient statement Is nor-
mally required on the front panel of
the label. If there la an ouUlde con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such ouUlde container
or wrapper. If the sfcte or form of the
package makes It Impracticable to
place the Ingredient statement on the
front panel of the label, permission
may be granted for the Ingredient
statement to appear elsewhere.
The teat of the Ingredient state-
ment must run parallel with other
Uxt on the panel on which It appear*.
and must be clearly distinguishable
from and must not be placed la the
body of other lexl
11) Name* to 6* sued In ingredient
Statement The name used for each In-
gredient shall be the accepted
common name. If there to one. fd-
lowrjl by the chemical name. The
commofr name may be uned alone only
If It to well known. If no common name
has been established, the chemical
name atone shall be uned. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted aa a common
name by the Administrator under the
authority of Section 25(cM6>.
M) Statement* o/ percentage*. The
percentages of Ingredients shall be
stated In terms of wnlghlto-wdght.
The sum of percentages of the active
and the Inert Ingredlenla shall be 100.
Percentages shall not be expressed by
a range ol values such aa "22-UX." If
the uses of the pesticide product are
expressed aa 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) vlccurocy q/ staled percentage*.
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 pres-
ent.
40) Deterioration. PestlcUes which
change In chemical composition sig-
nificantly must meet the following la-
beling requirements:
(II In cases where It b determined
thai a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement hi a prominent position on
the label: "Hot for sale or use after
Idalel.-
4111 The product must meet all label
claims up to the expiration time Indi-
cated on the label.
(II Inert Ingredient*. The Adminis-
trator may require the name of any
30
Inert IngredlenUs) to be listed In the
Ingredient statement II he determines
that such IngredlenUs) may pose a
hasard to man or the environment.
(h) Waminoi and prccaatlonar*
statement*. Required warnings and
precautionary statements concerning
the general areas ol toakooloajcal
hasard Including hasard to children.
environmental hasard. and physical or
chemical hasard fall Into two groups;
those required on Ihe front panel of
the labeling and those which
type
elsewhere. dprrlflr rrqiilre-
content. placement.
and prominence are given
(!> Rtgmtnd /rout panel statement*.
With the exception of thr child
hasard warning statement, the teat re-
quired on the front panel of thr label
b determined by Uw TosMljr Cntego-
ry of the paatklde. The catrcnry b as-
signed on .the basb of the highest
hasard shown by any of the Indicators
In the table behran
(I) Human nacanf slanaf toord—(A)
raxlclfy Category I. All pesticide prod-
ucts meeting the criteria of Toxldty
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition If the product was assigned to
Toilclty Category I on the basb of lla
oral. Inhalation or dermal toxldty (aa
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
In red on a background of distinctly
contrasting color and the skull and
croaabonra shall appear hi Immediate
proximity to the word "poison."
(11) roricily Category II. All pesti-
cide products meeting the criteria of
Toxldty Category II shall bear on the
front panel the signal word "Warn-
ing."
(CI Toxlclfy Catepory III. All pesti-
cide products meeting the criteria of
Toxfclly Category III shall bear on
the front panel the signal word "Cau-
tion."
(O) raxlci/y Category IV. All pesti-
cide products meeting the criteria ol
Toitclty Category IV shall bear on the
front panel the signal word "Caution.*
(E> UM oj tlgnat word*. Use ol any
signal word(s) associated with a higher
Toxldty Category b not permitted
except when the Agency determined
that such labeling b necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hasard
signal word appear on the front panel
of a label.
(ll> Child hatard SMmlna. Every pro-
Udde product label ahall beer on the
front panel the statement "kern out of
reach of children.** Only In nwm
where the likelihood ol contact with
children during distribution, market-
ing; storage or use b demonstrated by
the applicant to be extremely remol*.
or II Ihe nature ol the pesticide b auch
that It b approved lor use on Infants
or small children, may the Administra-
tor waive thb requirement.
(Ill) Statement o/ practical treat-
menf-(A) TbxtcUy Gufrporv f- A
statement of practical treatment (first
aid or other) ahall appear on the front
panel ol the label of all prattddra fall-
Ing Into Toxldty Category I on the
basb ol oral. Inhalation or dermal tox-
tdly. The Agency may. howrvrr.
permit reasonable variations In the
placement ol the atalement of prartl-
-------
f 162.10
cat treatment b aome reference nidi
M "See statement of practical treat-
mrnt on back panel" appear* on the
front panel near the word "Poison"
and the akull and cronbones.
(B) Other foxlclfy categories. The
statement ol practical treatment la not
required on the front panel except M
described In paragraph (hMlMlllMA>of
thli section. The applicant may. how-
ever. Include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elmwhere on the label In
accord with paragraph ) OD not kmS* «Mora f A* <
~ C« Ml •* to or**. OBIMK • a
fa^ih «n»»*i*
•**•!. ArcM binMi
AMU contact •«! Mi l*r** • rt**«l
ptaWMlM «*•»•« f*«*«4l. .
INo »«auftn>»
OMiarf*4^ €•!••• 9M >^ tfkll 4^MMV |af §kkl
Oo Hal |il to •»•». on «l*s gi on
WMI gotOiM •» ton •**» «n4 i
gto^. •!•» haUBn. ItoimM • fctol
(II) STnolronmentoJ hazard*. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired staling the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
Injury or damage. Example* of the
hazard statements and the circum-
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 LDW of
100 or leu. the statement "This Pesti-
cide In Tonic to Wildlife" In required.
IB) If a peiitlcMe Intended for out-
door line contains an active Ingredient
with a flah acute LCM of I ppm or taw.
the statement "Th|s Pesticide Is Toxin
to Fhh" Is required.
(C) If a pesticide Intended for out-
door use contains an active Ingredient
with an avlan acute oral LD» of 100
mg/kg or leas, or a aubaniile dietary
LCM of BOO ppm or less, the statement
"This Pcullclde la Toxic to Wildlife" In
required.
WH M at Mow i
O» Ml (Mnrtwf «f •«*«.«•
^ • urriMrcMwiH
(9) NOWWtaUMITO COHTMMM)
-.leitomV ijinH^ito K«|> o«or •«« »•.
I rj
-I"
II) Olrect«uacir and clar-
ify o/ directions. Directions for use
must be stated In terms which can be
easily read and understood by the
average person likely to use or to su-
pervise 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 effect* on the
environment.
(II) Placement o/ direction* /or use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic mailer which ac-
companies the pesticide provided that:
(A) If required by the Ageney. such
printed or graphic matter to securely
attached to each package of the pesti-
cide, or placed within the outaMe
wrapper or bag;
(B) The label bran a reference lo
the directions for use In accompanying
leaflet* or circular*, such an "flee di-
rections In the enclosed circular:" and
(C) The Admlntotrator determines
that It Is not necessary for such direc-
tions lo appear on the label.
(Ill) exceptions to recvlremenf /or
direction for we—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which arc Intended
for use only by manufacturers of prod-
uct* other than pesticide product* In
their regular manufacturing processes.
provided that-
-------
1162.10
U) The label clearly shows thai UK
product la Intended lor use only In
'manufacturing processes and •pedflc*
the type Immediately below the state-
ment of use classification, the state-
ment "Jl b a violation of Federal law
to use thb product In a manner Incon-
eblenl with IU labeling."
(Ill) The slte(s) of application, as for
example the crops, animals, areas, or
obJecU to be treated.
(Iv) The target peaUa) associated
with each site.
(v) The dosage rale associated with
each alto and peat.
(vl) The melhod of application. In-
cluding Instructions for dilution. It re-
quired, and type(s) of application ap-
paratus or equipment required.
(vl!) The frequency and timing of ap-
plications necessary to obtain effective
reaulU without causing unreasonable
adverse ef lecU on the environment.
(vlll) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting ' the requlremenU
concerning reentry provided by 40
CFR Part 170.
(U) Specific directions concerning
the storage and disposal of the pestl-
cldn and IU container, meeting the re-
quIremenU of 40 CFR Part 166. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal." Thb heading must be
set In type of the same minimum sines
as required for the child hazard warn-
ing (See Table In | IM.HXhXIXlv).)
(x) Any limitations or restrictions on
use required to prevent unreasonable
advene effecU. such as:
(A) acquired Intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings aa required against use
on certain crops, animals, oblecU. or
In or adjacent to certain areas.
(D) {Reserved!
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who Is not phys-
ically present at the site of application
Chapter I—tnvtrmmienlal f rejection Agency
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 b physically present.
(F) Other pertinent Information
which the Admlntatrator determines
to be necessary for the protection of
man and the environment.
(J) Statement of Vie CtuMl/icaffoii.
By October 3J. IB70. all pesticide prod
ucU mu.it bear on their labels a state-
ment of use classification as described
In paragraphs (JMI) and (3) of thb sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth In this sub-
section, and shall be marketed as sepa-
rate producU with different registra-
tion numbers, one bearing directions
only for general use(n) and the other
bearing directions for restricted une(s)
except that. If a product has both re-
stricted usc(a) and general uae(a). both
of these uses may appear on a product
labeled for restricted use. Such prod-
ucU shall be subject to the provisions
of | I63.IO(JX3>.
(I) General V»e Cfaisl/lcaflon. Pesti-
cide producU bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggeaU 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 mbbrandlng.
(2) Itocrlcfed Vie ClatHftcatlon.
Pesticide producU bearing direction
for iise(s> classified restricted shall
bear statcmenU of rci trlcted use clas-
sification on the front panel aa de-
scribed below:
(I) Front panel ilatevient a/ reffrtcl-
ed uje claj*l/lcaf Ion. (A) At the top of
the front psnrl of the label, set In type
of (he name minimum sizes aa required
for human hazard signal words (sea
table In 1leUOthXlXJv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to makr It unlikely to
be overlooked under customary condi-
tions of purchase and line, the state-
ment "Restricted Usn Pesticide." shall
appear.
(B) Directly below thb statement on
the front panel. • summary statement
of the terms of restriction Imposed as
a precondition to registration shall
appear. If use b restricted to eerllfled
applicators, the following statement Is
required: "For retail sale to ami use
only by Certified Applicators or »rr-
sons under their direct supervision mid
only for those uses covered by the Cer-
tified Applicator's certification." If.
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertblng. I Reserved I
HO PR M»a. July i. i»79; «o rn uaw.
AIIS. I. i»i8; 4« rn jesii. AUK. at. iti». •»
amended at 43 PR 5788. rVb. f. insi
I If 1.11 Criteria for •rlrrmmatlMis of <
i advene * fftrte.
fforfo for Itwance o/ Natt/r of
fnfenVto Deny Registration, (Jbncrl
RegMMtoH. or to Hold a llr/rlno •
(I) PreAfmpMon. (I) A rebutUhta pre
aumptlorXshall arise that a/otlco of
Intent to deny regtatratlon nnrsuanl to
section 3(c\6) of the AcUt notice of
registration pursuant
pXI) of IMe Ant. or a
to hob/ a hearing to
Intent to
to section
notice of i
determine
should be cancel
proprlate. shall
termination by the!
the pesticide
the criteria for
graph (aX3> of yitb
determlnal
shall Issue
registration
denied, as up-
upon a dn-
idmlnbtralor that
exceeds any of
I forth In para-
Ion. Upon such
the \Admlntatrator
by certified mall to
the applicant or regbtrarlL as the case
may be. Mating that the applicant or
registrant/ has the oppoliiinlly to
submit evidence In rebuttal of such
presumption In accordance wWh para-
graph AX4) of thb section. Trie appli-
cant of registrant shall have for\y fIvr
MB) days from the date such nnhce b
sen/to submit evidence In rebuttal of
presumption; provided. howe.Vr.
tRat for good cause shown the Admf
rator may grant an addition*!1) slxl"
35
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
'and not over 150°F.
0. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks/
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
97
-------
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20 °F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
0. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks/
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Oo not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Oo not use or store near
heat and open flame.
None required.
98
-------
• STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.-
99
-------
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,
stav 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.
100
-------
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 potential, 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 disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed
of on site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several
layers of newspaper and discard in trash."
101
-------
PEST/DIS-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with RCRA t and CAS
[40 CFR 261.33(e)]
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine (Avitrol)
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts
not otherwise specified)
Cyanogen chloride
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl]
phosphorodithioate (disulfoton)
0,0-Diethyl 0-pyrazinyl
phosphorothioate (Zinophos®)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexachlorohexahydro-exo,exo-
dimethanonaphthalene (Isodrin)
Hydrocyanic acid
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide
(OMPA, schradan)
Parathion
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
P003
P070
P004
POOS
P006
POOS
P010
P011
P012
P021
P022
P024
P030
P031
P037
P039
P040
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4
297-97-2
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8
102
-------
PEST/DIS-3
Strychnine and salts P108
0,0,0,0-Tetraethyl P109
dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate Pill
Thallium sulfate P115
Thiofanox P045
Toxaphene P123
Warfarin (>0.3%) P001
Zinc phosphide (>LO%) P122
57-24-9
60-41-3
3689-24-5
107-49-3
7446-18-6
39196-18-4
8001-35-2
81-81-2
1314-84-7
50 ACTIVES
II. PESTICIDES DERIVED FROM TRI-, TETRA-, AND PENTACHLOROPHENOLS
(40 CFR 261.31]
2-Chloroethyl 2-(2,4,6-trichloro- F027
phenoxy) ethyl ether
Dehydroabietylammonium F027
pentachlorophenoxide
Erbon F027
0-ethyl 0-(2,4,5-trichlorophenyl)
ethylphosphonothioate F027
2,2'-Methylenebis F027
(3,4,6-trichlorophenol)
(Hexachlorophene)
—Potassium salt ofc F027
—Sodium salt of F027
—Disodium salt of F027
Pentachlorophenol F027
—Potassium salt of F027
—Sodium salt of F027
—Zinc salt of F027
— Zinc salt of N-alkyl F027
(Cig-Cis)-1i3-propanediamine
—Pentachlorophenyl laurate F027
Potassium trichlorophenate (2,4,6) F027
Potassium trichlorophenate (2,4,5) F027
Silvex F027
—2-Butoxyethyl ester • F027
—Butoxypolypropoxypropyl ester F027
—Butoxypropyl ester F027
—Diethanolamine salt F027
—Diisopropanolamine salt F027
—Dimethylamine salt F027
—Dipropylene glycol isobutyl F027
ether ester
—Ethanolamine salt F027
—2-Ethylhexyl ester F027
—Isooctyl ester F027
5324-22-1
35109-57-0
136-25-4
327-98-0
70-30-4
67923-62-0
3247-34-5
5736-15-2
87-86-5
7778-73-6
131-52-2
2917-32-0
3772-94-9
2591-21-1
35471-43-3
93-72-1
19398-13-1
53404-07-2
25537-26-2
51170-59-3
53404-09-4
55617-85-1
53535-26-5
7374-47-2
53404-76-5
53404-14-1
103
-------
PEST/DIS-4
—Isopropanolamine salt
~Monohydroxylaluminum salt
—Polypropoxypropyl ester
—Potassium salt
—Propylene glycol isobutyl
ether ester
—Sodium salt
—Triethanolamine salt
—Triethylamine salt
—Triisopropanolamine salt
—Tripropylene glycol isobutyl
ether ester
Sodium 2-(2,4,5-trichlorophenoxy)
ethyl sulfate
Tetrachlorophenols
—Alkylamine*amine salt (as in
fatty acids of coconut oil)
—Potassium salt
—Sodium salt
2,4,5-Trichlorophenol
2,4 r 6-Trichlorophenol
2,4,5-Trichlorophenol salt of
2,6-bis[(dimethylamino)methyl]
cyclohexanone
2,4,5-Trichlorophenol, sodium salt
2,4,6-Trichlorophenol, sodium salt
2,4,5-Trichlorophenoxyacetic acid
—Alkyl C-12 amine salt
—Alkyl C-13 amine salt
—Alkyl C-14 amine salt
—N,N-diethylethanolamine salt
—Dimethylamine salt
—N,N-dimethyllinoleylamine salt
—N,N-dimethyloleylamine salt
—N-oleyl-1,3-propylene
diamine salt
—Sodium salt
—Triethanolamine salt
—Triethylamine salt
—Alkyl (C3H7 - C7H9) ester
—Amyl ester
—Butoxyethoxypropyl ester
—2-Butoxyethyl ester
—Butoxypropyl ester
—Butyl ester
—Dipropylene glycol isobutyl
ether ester
—2-Ethylhexyl ester
— Isobutyl ester
F027 53404-13-0
F027 69622-82-8
F027 83562-66-7
F027 2818-16-8
F027 53466-84-5
F027 37913-89-6
F027 17369-89-0
F027 53404-74-3
F027 53404-75-4
F027 53535-30-1
F027 3570-61-4
F027 25167-83-3
F027
F027 53535-27-6
F027 25567-55-9
F027 95-95-4
F027 88-06-2
F027 53404-83-4
F027 136-32-3
F027 3784-03-0
F027 93-79-8
F027 53404-84-5
F027 53404-85-6
F027 53535-37-8
F027 53404-86-7
F027 6369-97-7
F027 53404-88-9
F027 53404-89-0
F027 53404-87-8
F027 13560-99-1
F027 3813-14-7
F027 2008-46-0
F027
F027 120-39-8
F027 1928-58-1
F027 2545-59-7
F027 1928-48-9
F027 93-79-8
F027 53535-31-2
F027 1928-47-8
F027 4938-72-1
104
-------
PEST/DIS-5
—Isopropyl ester F027
—Propylene glycol isobutyl F027
ether ester
—Tripropylene glycol isobutyl F027
ether ester
4-{2/4, 5-Trichlorophenoxy)butyric F027
acid [2,4,5-TB]
2-(2,4,5-Trichlorophenoxy)ethyl F027
hydrogen sulrate [2,4,5-TES]
1,4',5'-Trichloro-2'-(2,4,5- F027
trichlorophenoxy)
methanesulfonanilide [Edolan U]
93-78-7
53466-86-7
53535-32-3
93-80-1
69633-04-1
69462-14-2
105
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PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST (with
[40 CFR 261.33(f)j
Acetone
Acrylonitrile*
Ami t role
Benzene*
Bis( 2-ethylhexyl}phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
( chloroacetaldehyde )
Chlordane, technical*
Chlorobenzene*
4-Chloro-m-cresol
Chloroform*
o-Chlorophenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorooctahydro-1 , 3 , 4-metheno-
2H-cyclobuta (c ,d] -pentalen-2-one
(Kepone, chlordecone)
1 , 2-Dibromo-3-chloropropane ( DBCP )
Dibutyl phthalate
S-2,3-(Dichloroallyl diisopropyl-
thiocarbamate) (diallate /Avadex)
o-Dichlorobenzene*
p-Dichlorobenzene*
Dichlorodifluorome thane
(Freon 12®)
3 , 5-Dichloro-N- ( 1 , 1-dimethy 1-2-
propynyl) benzamide
(pronamide, Kerb*)
Dichloro diphenyl dichloroethane
(DDD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2 , 4-Dichlorophenoxyacetic ,
salts and esters (2,4-D)*
1 , 2-Dichloropropane
1 ,3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
( l-chloro-2 , 3-epoxypropane )
Ethyl acetate
Ethyl 4,4 '-dichlorobenzilate
( chlorobenzilate)
RCRA #,
U002
U009
U011
U019
U028
U136
U211
U034
U036
CJ037
U039
U044
U048
U051
U052
U056
U057
U142
U066
U069
U062
U070
U072
U075
U192
U060
U061
U025
U240
U083
U084
U102
U041
U112
U038
and CAS *
67-64-1
107-13-1
61-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0
57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
96-12-8
84-74-2
2303-16-4
95-50-1
106-46-7
75-71-8
23950-58-5
72-54-8
50-29-3
1191-17-9
94-75-7
8003-19-8
542-75-6
131-11-3
106-89-8
141-78-6
510-15-6
*Proposed tor deletion by TCLP proposal
106
-------
PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane*
Hydrofluoric acid
Isobutyl alcohol*
Lead acetate
Lindane*
Naleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol (methanol)
Methyl bromide
Methyl chloride
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(hexachlorophene)
[acute waste per 261.311
Methylene chloride*
Methyl ethyl ketone*
4-Methyl-2-pentanone
(methyl isobutyl ketone)
Naphthalene
Nitrobenzene*
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentachlorophenol*
[acute waste per 261.31]
Phenol*
Pyridine*
Resdrcinol
Safrole
Selenium disulfide
Silvex [acute waste per 261.31]
1,1,2,2-Tetrachloroethane*
Tetrachloroethylene*
2,3,4,6-Tetrachlorophenol*
[acute waste per 261.31]
Thiram
Toluene*
1,1,1-Trichloroethane*
(methyl chloroform)
Trichloroethylene*
Trichloromonofluoromethane
(Freon 11®)
2,4,5-Trichlorophenol*
[acute waste per 261.31]
2,4,6-Trichlorophenol*
[acute waste per 261.31]
107
U067
U077
U115
U122
U125
U127
U130
U131
U134
U140
U144
U129
U148
U151
U247
U154
U029
U045
U132
106-93-4
107-06-2
75-21-8
50-00-0
98-01-1
118-74-1
77-47-4
67-72-1
7664-39-3
78-83-1
301-04-2
58-89-9
123-33-1
7439-97-6
72-43-5
67-56-1
74-83-9
74-87-3
70-30-4
U030
U159
U161
U165
U169
U170
U134
U185
U242
U188
U196
U2tfl
U203
U205
U233
U209
U210
U212
U244
U220
U226
U228
U121
U230
U231
75-09-2
78-93-3
108-10-1
91-20-3
98-95-3
100-02-7
76-01-7
82-68-8
87-86-5
108-95-2
110-86-1
108-46-3
94-59-7
7488-56-4
93-72-1
79-34-5
127-18-4
137-26-8
108-88-3
71-55-6
79-01-6
75-69-4
95-95-4
88-06-2
-------
PEST/DIS-8
2,4,5-Trichlorophenoxyacetic acid U232 93-76-5
(2,4,5-T)*
[acute waste per 261.31]
Warfarin «0.3%) U248 81-81-2
Xylene U239 1330-20-7
Zinc phosphide «10%) U249 1314-84-7
83 ACTIVES
108
-------
III. USE INDEX APPENDIX
109
-------
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
TABLE OF COMTEK-IS
Site Same ' Page
DOMESTIC OUTDOOR 3
(Wood or Wood Structure Protection Treatments) 3
Terrestrial Structures 3
IMDOOR 14
(Wood or Wood Structure Protection Treatments) 14
Terrestrial Structures 14
Wood Protection Treatment of Seasoned Forest Products 14
Wood Protection Treatment of Unseasoned Forest Products 14
Issued: 8-29-64 III-058201-1
Provisional Update: 12-04-66
110
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EPA Compendium of Acceptable Uses
C058201 CHLORDANE, TECHNICAL*
TYPE PESTICIDE; Insecticide
FORMULATIONS;
Tech (100%)
FI (4 Ib/gal, 8 Ib/gal, 49Z, 53.7Z, 95Z)
G (20Z)
EC (2 Ib/gal, 4 Ib/gal, 4.17 Ib/gal, 4.2 Ib/gal, 8 Ib/gal, 10Z, 20Z,
23.65Z, 25Z, 40Z, 42Z, 44Z, 45Z, 45.3Z, 46Z, 46.7Z, 48Z, 50Z, 52.1Z,
62.5Z, 72Z, 73Z, 73.5Z, 74Z, 74.35Z)
SC/L (3Z, 4.25Z, 20Z)
RTU (1.07Z)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE PESTICIDE. Chlordane
is toxic to fish and wildlife. Keep out of lakes, streams or ponds. Ap-
plicators must wear water resistant hat, lightweight protective suit or
coveralls, unlined chemical-resistant gloves (natural rubber, neoprene,
or polyethylene), and unlined lightweight boots. MSHA/OSHA approved res-
pirators are required for applications in enclosed areas such as crawl
spaces. Mixer/loaders must wear goggles or a face shield, chemical-
resistant apron, long-sleeved shirt, long pants, or coveralls, and un-
lined, mid-forearm to elbow length chemical-resistant gloves when mixing,
loading, or otherwise handling the concentrate.
Do not apply chlordane in or around poultry houses, barns, silos, milk
houses, or other structures or enclosures where livestock or poultry is
held, or where food/feed is stored, prepared or processed. Do not apply
chlordane to plenum houses (houses where the crawlspace beneath the build-
ing is used to circulate heated or cooled air without ductwork). Do not
contaminate feed and foodstuffs.
Agricultural Crop Tolerances;
Apples 0.3 ppm
Apricots 0.3 ppm
Beans 0.3 ppm
Beets, Green (alone) 0.3 ppm
Beets, with tops 0.3 ppm
Beets, without tops 0.3 ppm
Blackberries 0.3 ppm
Blueberries (Huckleberries) 0.3 ppm
Boysenberries 0.3 ppm
Broccoli 0.3 ppm
Brussels Sprouts 0.3 ppm
Cabbage 0.3 ppm
Carrots 0.3 ppm
Cauliflower 0.3 ppm
Celery 0.3 ppm
Cherries 0.3 ppm
Citrus Fruits 0.3 ppm
Collards 0.3 ppm
Corn 0.3 ppm
Cucumbers 0.3 ppm
Dewberries 0.3 ppm
Eggplant 0.3 ppm
*Chlordane
Issued: 8-29-84 III-058201-1
Provisional Update: 12-04-86
111
-------
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
GENERAL WARNINGS AND LIMITATIONS (continued)
Grapes
Kale
Kohlrabi
Lettuce
Loganberries
Melons
Nectarines
Okra
Onions
Papayas
Peaches
Peanuts
Pears
Peas
Peppers
Pineapples
Plums (Fresh Prunes)
Potatoes
Quinces
Radishes, tops
Radishes, with tops
Radishes, without tops
Raspberries
Rutabagas, tops
Rutabagas, with tops
Rutabagas, without tops
Squash
Squash, Summer
Strawberries
Sweet Potatoes
Tomatoes
Turnips, Greens
Turnips, with tops
Turnips, without tops
Youngberrles
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
0.3 ppm
Issued: 8-29-84
III-058201-2
112
-------
Site and Pest
DOMESTIC OUTDOOR
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Dosages and Tolerance, Use, Limitations
Formulatlon(a)
/64000NA
IMGDAGA
(Wood or Wood Structure Protectloa Treatments)
Terrestrial Structures
Subterranean ter-
mites (Including
Coptoteraes,
Heterotermes,
Retlculitermes,
and Zootermopsls
spp.)
0.5Z emulsion
[may give
satisfactory
control]
or
1Z emulsion
[common
recommenda-
tion]
or
2Z emulsion
[for Copto-
termes spp.
or longer
residual
control]
(4, 4.17, 8
Ib/gal EC)
(42*. 442,
45Z, 46Z,
50Z, 72Z,
73Z, 74Z,
74.35Z EC)
or
1Z solution
in kerosene
or
2Z solution
in kerosene
[for copto-
termls spp.]
(20Z SC/L)
—OR MAI—
Soil contact nonfumigatlon treat-
ment.
Use limited to professional pest
control operators. These formula-
tions are designed for treatment of
soil to establish a barrier which
is lethal to termites. Chlordane
must be adequately dispersed in the
soil to provide a barrier between
the wood in the structure and the
termite colonies in the soil or to
control termites living in the
structure.
It is necessary for the effective
use of chlordane that the service
technician be familiar with current
control practices including trench-
ing, redding, subslab injection, and
low pressure spray application.
These techniques must be correctly
employed to prevent or control in-
festations by subterranean termite
species of Coptotermes, Hetero-
termes, Reticulitennes and Zooter-
mopsis. Choice of appropriate pro-
cedures includes consideration of
such variable factors as the design
of the structure, water'table, soil
type, soil compaction, grade condi-
tions and location and type of do-
mestic water supplies. The biology
and behavior of the Involved termite
species are important factors to be
known as well as suspected location
of the colony and severity of the
infestation within the structure to
be protected. For advice concerning
current control practices for speci-
fic local conditions, consult re-
sources in structural pest control.
Annual inspections of the treated
area should be made. Soil should
not be treated when excessively wet.
The termites' source of moisture
Issued: 8-29-84
III-05820L-3
113
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EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Site and Pest Dosages and Tolerance, Use, Limitations
Formulatioa(s)
Terrestrial Structures (continued)
[w/HEPTA- should be eliminated by providing a
CHLOR] chemical barrier and/or repairing
0.5-12 emul- faulty construction.
s ion Contamination of public and private
or water supplies must be avoided by
12 emulsion following these precautions: Use
[for Copto- anti-backflov equipment or proce-
termis spp.] dures to prevent siphonage of pes-
(2, 4, 4.2 ticide back into water supplies.
Ib/gal EC) Do not treat soil that is water
(23.65% EC) saturated or frozen. Consult state
or and local specifications for recom-
[w/DIELDRIN mended distances of treatment areas
and 2-BU- from wells, and refer to Federal
TOXYETHANOL] Housing Administration (F.H.A.) Spe-
0.52 emulsion cifications for further guidance.
(52.12 EC) All nonessential wood and cellulose
containing materials, including
scrap wood and form boards, should
be removed from around foundation
walls, crawl spaces, and porches.
PRECONSTRUCTION SUBTERRANEAN TERMITE
TREATMENT
Effective preconstruction subterra-
nean termite control requires the
establishment of an unbroken verti-
cal and/or horizontal chemical bar-
rier between wood In the structure
and the termite colonies in the
soil. To meet F.H.A. termite proof-
Ing requirements, follow the latest
edition of the Housing and Urban
Development (H.U.D.) Minimum Proper-
ty Standards. After grading is com-
pleted and prior to the pouring of
the slab, slab supported/constructed
porches, or entrance platforms, make
the following treatments. Applica-
tions shall be made by a low pres-
sure spray for horizontal barriers
over areas intended for covering
floors, porches, and other critical
areas. Establish a vertical barrier
in areas such as around the base of
foundations, plumbing, back-filled
soil against foundation walls, and
other critical areas.
Issued: 8-29-84 III-058201-4
114 '
-------
Site and Pest
EPA Compendium of Acceptable Uses
CHLQRDANE, TECHNICAL
Dosages and Tolerance, Use, Limitations
Formulation( a)
Terrestrial Structures (continued)
Where it is necessary to produce
a horizontal barrier, apply the
emulsion at the rate of 1 gallon
of emulsion per 10 square feet
of dirt fill. If fill is washed
gravel or other coarse material,
apply at 1.5 gallons of emulsion
per 10 square feet. It is im-
portant that the emulsion reach-
es the soil substrate.
a. If concrete slabs cannot be
poured over soil the same
day it has been treated, a
waterproof cover, such as
polyethylene sheeting,
should be placed over the
soil. This is not necessary
if foundation walls have
been installed around the
treated soil.
To produce a vertical barrier,
apply the emulsion at the rate
of 4 gallons of emulsion per 10
linear feet per foot of depth.
a. Rodding and/or trenching ap-
plications should not be
made below the top of the
footing.
b. Trench need not be wider
than 6 inches.
c. Rod holes should extend from
the base of the trench to
the top of the footing, and
should be spaced (about 1
foot) to provide a continu-
ous barrier.
d. Emulsion should be mixed
with the soil as it is being
replaced in the trench.
Cover treated soil with a
layer of untreated soil.
Hollow block foundations or
voids of masonry should be
treated to make a continuous
chemical barrier in voids. Ap-
ply at the rate of 2 gallons of
emulsion per 10 linear feet so
it will reach the footing.
Issued: 8-29-84
III-058201-5
115
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Site and Pest
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Dosages and Tolerance, Use, Limitations
Formulatioa(s)
Terrestrial Structures (continued)
4. For crawl spaces apply at the
rate of 4 gallons of emulsion
per 10 linear feet per foot of
depth from grade to bottom of
foundations. Application may
be made by rodding, low pressure
spray, and/or trenching. Treat
both sides of foundation and
around all piers and pipes.
a. Rod holes should be spaced
(about 1 foot) to provide a
continuous chemical barrier.
b. Trench need not be wider
than 6 inches nor below the
foundation. The emulsion
should be mixed with the
soil as it Is being replaced
in the trench. Cover the
treated soil with a layer
of untreated soil.
c. Do not apply in any manner
to an area intended as a
plenum air space.
d. Do not apply as an overall
treatment to soil in crawl
spaces.
All holes drilled in construction
elements for treatment should be
securely plugged.
POSTCONSTRUCTION TREATMENTS
Postconstructlon applications shall
be made by injection, rodding, low
pressure spray, and/or trenching.
Do not apply emulsion until location
of heat or air conditioning ducts,
vents, water and sewer lines, or
electrical conduits are known and
identified. Extreme caution must
be taken to avoid contamination of
these structural elements and air-
ways. Do not apply in any manner
to an area Intended as a plenum air
space.
1. For slab-on-ground construction
apply at the rate of 4 gallons
of emulsion per 10 linear feet.
Application may be made by sub-
Issued: 8-29-84
III-058201-6
116
-------
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Site and Pest Dosages and Tolerance, Use, Limitations
Formulations)
Terrestrial Structures (continued)
slab Injection. Injectors
should not extend beyond the
tops of the footings. Treat
along the outside of the founda-
tion and where necessary on the
Inside of foundation walls.
Treatment may also be required
along 1 side of interior parti-
tions and along all cracks and
expansion Joints.
a. Drill holes in the slab to
provide a continuous chemi-
cal barrier.
b. Where necessary, drill
through the foundation walls
from the outside and force
the emulsion just beneath
the slab or along all the
cracks and expansion joints
and other critical areas.
c. For shallow foundations, 1
foot or less, dig a narrow
trench approximately 6 inch-
es wide along the outside
of the foundation walls.
Do not dig below the bottom
of the foundation. The
emulsion should be applied
to the trench and the soil
at the rate of 4 gallons of
emulsion per 10 linear feet
as the soil is replaced in
the trench. Cover the
treated soil with a layer
of untreated soil.
d. For foundations deeper than
1 foot follow rates for
basements.
Hollow block foundations or
voids of masonry should be
treated to make a continuous
chemical barrier in voids. Ap-
ply at the rate of 2 gallons of
emulsion per 10 linear feet.
For basements apply at the rate
of 4 gallons of emulsion per 10
linear feet. Where footings are
greater than 1 foot of depth
Issued: 8-29-84 III-058201-7
117
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Site and Pest
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Dosages and Tolerance, Use, Limitations
Formulations)
Terrestrial Structures (continued)
from the grade to the bottom of
the foundation, application may
be made by trenching and/or rod-
ding. Treat outside of founda-
tion walls, and if necessary
along inside of foundation
vails, along cracks in basement
floors, along interior load
bearing walls, around sewer
pipes, conduits, and piers.
A. In crawl spaces apply at the
rate of 4 gallons of emulsion
per 10 linear feet per foot of
depth from grade to bottom of
foundation. Application may be
made by rodding, and/or trench-
Ing. Treat both sides of foun-
dation and around all piers and
pipes.
a. Rod holes should be spaced
(about 1 foot) to provide a
continuous chemical barrier.
b. Trench need not be wider
than 6 Inches nor below the
foundations. The emulsion
should be mixed with the
soil as it is replaced in
the trench. Cover the
treated soil with a layer
of untreated soil.
c. Do not apply in any manner
to an area intended as a
plenum air space. After
treatment, securely plug all
holes drilled in construc-
tion elements.
d. Do not apply as an overall
treatment to soil in crawl
spaces.
All holes drilled in construction
elements for treatment should be
securely plugged.
RETREATMENT RESTRICTIONS
Retreatment for subterranean ter-
mites should only be made when there
is evidence of relnfestatlons subse-
quent to the initial treatment, or
Issued: 8-29-84
III-05820L-6
118
-------
Site and Pest
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Dosages and Tolerance, Use, Limitations
Formulations)
Terrestrial Structures (continued)
0.52 emulsion
[for minimum
control]
or
IZ emulsion
[common
recommenda-
tion]
or
2Z emulsion
[for copto-
termes spp.]
(4, 8 Ib/gal
EC)
(10%, 20%,
25Z, 40Z,
42Z, 45Z,
45.3%, 46%,
46.7%, 48%,
50%, 62.5%,
72Z, 73Z,
73.52, 74Z,
74.35Z EC)
there has been a disruption of the
chemical barrier in the soil due to
construction, excavations, or land-
scaping. Reapplication should be
made as a spot treatment to these
areas. Avoid annual retreatment of
the entire premises.
OR MAI
May be formulated with heptachlor
or dieldrin and 2-butoxyethanol.
Soil contact nonfumigation treat-
ment. Use available to homeowners.
TERMITE CONTROL IN EXISTING STRUC-
TURES
Buildings with Basements or Crawl-
Spaces
First remove all wood debris and
wood forms. Around piers, pipes,
chimney bases and along foundations
of poured concrete dig a trench 6
Inches wide and 4 inches deep. For
brick and block foundations dig the
trench about 12 Inches deep. If
footing is more than 12 inches deep,
make holes with a crowbar, pipe or
a rod about one foot apart that ex-
tends from the trench bottom to top
of the footing. Make holes closer
in hard-packed clay soils. Never
dig below the top of the footing.
Apply the emulsion in the trench at
a rate of 4 gallons per 10 linear
feet of depth. Apply half of this
to the back-fill. Likewise, treat
along the inside of foundations of
crawl-space buildings. Cover treat-
ed soil with a thin layer of un-
treated soil.
For raised porches, terraces, and
entrance slabs, drill holes at one
foot intervals, 6 inches from the
foundation, and pour one-half gallon
of emulsion into each hole. Refill
holes. Slabs with heat ducts or
radiating heat pipes should be
treated by commercial pest control
operator.
Issued: 8-29-84
III-058201-9
119
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EPA Compendium of AccepCable Uses
CHLORDANE, TECHNICAL
Site and Pest Dosages and Tolerance, Use, Limitations
Foraulatlon(8)
Terrestrial Structures (continued)
The object is to establish a treated
soil barrier which will prevent ter-
mite entry. Other critical areas
may also require treatment, particu-
larly if there are inaccessible
areas, basements or slab-type con-
struction. Consult your Agricultur-
al Cooperative Extension Service or
a Commercial Pest Control Service.
Avoid contamination of public and
private water supplies by following
these precautions. Do not allow a
hose or any type of faucet extension
to reach into the termite chemical
emulsion while filling or mixing
this material with water. Use anti-
backflow or anti-siphonage equipment
on all filling equipment. These
devices can be purchased at hardware
or plumbing supply stores. Use of
anti-backflow equipment will help
to insure that the user of this
toxic chemical will not contaminate
domestic water supplies. Refer to
Federal (Federal Housing Administra-
tion), state and local specifica-
tions for safe distances of treat-
ment areas from wells. Soil in the
vicinity of wells, cisterns, or
ponds should not be treated if it
is water saturated, subject to ex-
cessive saturation due to an accumu-
lation of water, or if the soil to
be treated around the perimeter of
the structure is at a grade lower
than surrounding yard or property
area. If this is the situation
treat as follows: Do not apply un-
der pressure. Soil should be remov-
ed to an area safe from well or do-
mestic water contamination, treated,
allowed to stand undisturbed for two
to four hours then returned to the
trench which has been lined with 4
mil. plastic sheeting. Be careful
not to puncture the plastic sheeting
when returning soil to the trench.
Do not treat structures that contain
Issued: 8-29-84 111-058201-10
120
-------
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(9)
Terrestrial Structures (continued)
cisterns or wells. Note: Labels
000239-01232 and 009591-00006 pro-
vide directions for application with
a hose end proportioned Also note
that 009591-00006 provides direc-
tions for application with sprink-
ling can.
cartridges TREATING EXISTING CONSTRUCTION
containing Houses with Basements
20Z G nInsert the black injection tube
(20Z 6) to full depth and dispense a
load of three cartridges every
linear foot around the perimeter
of the house, always keeping the
injector within 6 inches of the
outside wall.
2. Treat any areas in basement
where soil is exposed as direct-
ed in the section on crawl
spaces below.
3. If mud tunnels or other evidence
of termite Infestation appear
along inside basement walls, use
a 0.5 inch masonry drill, drill
holes 1 inch apart and treat in-
fested areas as recommended in
Crawl Spaces. Avoid drilling
into plumbing, heating,or elec-
trical outlets.
Crawl Spaces
1. Insert the yellow injection tube
into the soil and dispense 1.5
cartridges every linear foot
around the perimeter of the
house, keeping within 6 inches
of the outside foundation walls.
2. Repeat step 1 along the inside
of the foundation walls, also
around piers, chimneys, sewer
pipes, conduits and other areas
where termite entry is possible.
Buildings and Attached Structures
with Concrete Slab on Surface
1. Insert the yellow injection tube
into the soil and dispense 1.5
cartridges every linear foot
around the perimeter of the area
Issued: 8-29-84 III-0582Q1-11
121
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EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Terrestrial Structures (continued)
to be treated, keeping within 6
inches of outside foundation
walls.
2. Repeat step 1 wherever soil is
exposed on the inside of the
foundation walls, alongside par-
titions, around sewer pipes,
utility entrances, conduits,
chimneys, piers and all areas
where termite entry is possible.
If already infested, this treat-
ment is especially important.
Note: If tube cannot be insert-
ed in crevice between wall and
foundation, drill holes where
necessary. Avoid drilling into
plumbing, heating, or electrical
outlets.
Concrete, Asphalt or Masonry Porch-
es, Sidewalks, Driveways, Floors and
Other Areas Adjacent to Foundation
Insert the yellow tube and dispense
1.5 cartridges every linear foot
along the exterior of the foundation
wall. If already infested, this
treatment is especially important.
Note: If tube cannot be inserted
in crevice between wall and adjoin-
ing concrete, drill holes where ne-
cessary. Avoid drilling into plumb-
ing, heating, or electrical outlets.
TREATMENT DURING CONSTRUCTION
Note: If concrete slabs cannot be
poured over soil treated the same
day, a waterproof cover, such as
polyethylene sheeting should be
placed over the soil. However, this
is not necessary if foundation cin-
der blocks or bricks surrounding the
treated area have already been in-
stalled.
1. Treat all areas as per instruc-
tions under "Treating Existing
Construction".
2. Using the yellow tube, dispense
3 cartridges per linear foot in-
to the soil along inside of
Issued: 8-29-84 111-058201-12
122
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Site and Pest
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Dosages and Tolerance, Use, Limitations
FormulationCs)
Terrestrial Structures (continued)
D1GAAM
Termites
2.3-5.5 gal
32 SC/L/100
gal water
(3Z SC/L)
foundation walls, under the con-
crete (basement) flooring, along
walls, under porches and around
all pipes, conduits, etc.
3. Without inserting into the soil,
and with the valve slightly open
to allow a small flow of water,
dispense 3 cartridges per 7.5
square feet as an overall treat-
ment under all concrete areas
that will be beneath slabs. In
case of washed gravel, cinders
or similar coarse material, in-
crease the dosage by at least
0.5 (3 cartridges for every 5
square feet).
Note: Avoid contamination of public
and private water supplies by fol-
lowing these precautions. Use antl-
backflow siphonage equipment (stan-
dard with soil injector). Refer to
Federal (Federal Housing Administra-
tion) , state and local specifica-
tions for safe distances of treat-
ment areas from wells. Soil in the
vicinity of wells should not be
treated if it is water saturated,
or by injecting the solution under
pressure. Soil should be removed
to an area safe from well contamina-
tion, treated, and returned to the
trench which has been lined with
plastic sheeting.
Nonaoil contact nonfuaigation treat-
ment. Apply by brush, spray, or
dip. The strength of the solution
used depends upon the degree of ter-
mite activity.
Issued: 8-29-84
111-058201-13
123
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EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Site and Pest Dosages and Tolerance. Use, Limitations
Formulation(s)
Terrestrial Structures (continued)
gallons of 31
SC/L/100
condition gallons water
low termite activity 2.3
moderate termite
activity 3.9
high termite activity 5.5
remedial treatment when
termites are in or
around the structure 5.5
Where feasible make 2 to 3 applica-
tions 3 to 10 minutes apart.
Formulated with copper 8-qulnolino-
late.
INDOOR
(Wood or Wood Structure Protection Treatments)
/64000KA Terrestrial Structures
See DOMESTIC OUTDOOR, Terrestrial Structures for
use and limitation information.
/640028B Wood Protection Treatment of
Seasoned Forest Products
/64001MB Wood Protection Treatment of
Unseasoned Forest Products
HfGDAGA Subterranean ter- 12 emulsion Nonsoil contact nonfumlgation treat-
mites (including or ment. Where it is desired, wood im-
Coptotermes, 2% emulsion pregnation may be accomplished by
Heterotermes, [for Copto- techniques such as wood injection;
Retlculitermes, tennis spp.] treating galleries, tubing, nests
and Zootermopsla (8 Ib/gal EC) or other places where termites may
spp.) be hiding. Injection may be accom-
plished by inserting or driving a
tapered "hammered head" treating
tool or inserting needle nozzles
into such sites. Do not apply be-
yond the point of runoff. Close
all treatment holes.
Issued: 8-29-84 111-058201-14
124
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Site and Pest
EPA Compendium of Acceptable Uses
CHLORDANE, TECHNICAL
Dosages and Tolerance, Use, Limitations
Fomulation(s)
Wood Protection Treatment of Seasoned Forest Products cluster (contin-
IMGAAAA
Termites
1 gal 4.25Z
SC/L/4.5
gal mineral
spirits
(4.25Z SC/L)
or
Nonsoil contact nonfumigation treat-
ment. Apply as a surface or pres-
sure treatment to timber.
Formulated with 2-naphthol, 2-
butoxyethanol, dlacetone alcohol,
mineral spirits, pine oil and 1,2,4-
apply without trichlorobenzene.
dilution
(1.07Z 8TU)
Issued: 8-29-84
III-0582Q1-15
125
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IV. BIBLIOGRAPHY APPENDICES
126
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• BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF 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 OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for 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.
127
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BIBGUIDE-2
a. Author. Whenever the Agency could confidently identity
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:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
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 "COL," 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 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
128
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OFFICE Of PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data base Supporting
Registrations Under the Chlordane Standard
MRID CITATION
00067012 Union Carbide Corporation (1976) Acute Toxicity of Chlordane 4EC
to Daphnia magna. (Unpublished study received Aug 31, 1976
under 876-86; submitted by Velsicol Chemical Corp., Chicago,
111.; CDL:227284-G)
00068561 Heitrauller, T. (1975) Acute Toxicity of Belt 72 B.C. to Pink Shrimp
(Penaeus duorarum) and Fiddler Crabs (Uca pugilator).
(Unpublished study received Aug 12, 1977 under 876-102; prepared
by Bionomics—E3G & G, Inc., submitted by Velsicol Chemical
Corp., Chicago, 111.; CDL:232769-A)
00068574 Bentley, R.E. (1974) Acute Toxicity of Belt 72 EC to Rainbow Trout
(Salrao gairdneri). (Unpublished study received Auy 12, 1977
under 876-102; prepared by Bioncmics, EG & G, submitted by
Velsicol Chemical Corp., Chicago, 111.; CDL:232771-A)
00068575 Bentley, R.E. (1974) Acute Toxicity of Belt 72 EC to Bluegill
(Lepomis macrcchirus). (Unpublished study received Aug 12,
1977 under 876-102; prepared b^ Bionomics, EG & G, submitted by
Velsicol Chemical Corp., Chicago, 111.; CDL:232770-A)
00083966 Mayhew, D.A.; Abbott, L.; Johnson, Y.L.; et al. (1981) Acute Eye
Irritation Study in Albino Rabbits with Chlocdane 8 EC: Project
No. WIL-81228. (Unpublished study received Sep 22, 1981 under
876-63; prepared by WIL Research Laboratories, Inc., submitted
by Velsicol Chemical Corp., Chicago, 111.; CDL:245943-A)
00085950 Heath, R.G.; Spann, J.W.; Hill, E.F.; et al. (1972) Comparative
Dietary Toxicities of Pesticides to Birds. By U.S. Fish and
Wildlife Service, Patuxent Wildlife Research Center. ?:
USFWS. (Special scientific report—wildlife no. 152; pp. 23,27,
30,33-36,38-41,44 only; published study; CDL:070329-E)
00086221 Union Carbide Corporation (1976) Acute Toxicity of Chloroheptcn
#6 to Bluegill Sunfish, Lepomis macrcchirus Rafinesque, Rain-
bow Trout, Salmo gairdneri Richardson, and the Water Flea,
Daphnia magna Staus. (Unpublished study received Dec 22,
1976 under 876-181; submitted by Velsicol Chemical Corp., Chica-
go, 111.; CDL:227407-1)
129
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordane Standard
MRID CITATION
00086222 Union Carbide Corporation (1976) Acute Toxicity of Chlorohepton #6
to Grass shrimp,: palaemonetes vulgaris and Fiddler Crabs, uca
pugilator. (Unpublished study received Dec 22, 1976 under
876-181; submitted by Velsicol Chemical Corp., Chicago, 111.;
CDL:227407-J)
00103880 Caimbacher, C. (1978) The Acute Toxicity of Chlordane Technical
Reference Standard 100% Active Ingredient, Lot B8113 to the
Bluegill Sunfish ...: UCES Proj. No. 11506-03-68. (Unpublished
study received Aug 15, 1978 under 876-63; prepared by Union
Carbide Corp., submitted by Velsicol Chemical Corp., Chicago,
IL; CDL:234639-B)
00103881 Caimbacher, C. (1978) The Acute Toxicity ot Chlordane Technical
Reference Standard 100% Active Ingredient, Lot B8113 to the
Rainbow Trout ...: UCES Pro]. No. 11506-03-69. (Unpublished
study received Aug 15, 1978 under 876-63; prepared by Union
Carbide Corp., submitted by Velsicol Chemical Corp., Chicago,
IL; CDL:234639-C)
00103882 Bentley, R. (1974) Acute Toxicity of Gold Crest Termide to Rain-
bow Trout (Salmo gairdneri). (Unpublished study received
Jan 29, 1975 under unknown admin, no.; prepared by Bionomics,
EG & G Environmental Consultants, submitted by Velsicol Chem-
ical Corp., Chicago, IL; CDL:235576-A)
00103885 Morrissey, A. (1978) The Acute Toxicity or Chlordane Technical
Reference Standard to the Water Flea ...: UCES Pro]. No. 11506-
03-70. (Unpublished study received Feb 28, 1979 under 876-
273; prepared by Union Carbide Corp., submitted by Velsicol
Chemical Corp., Chicago, IL; CDL:237899-C)
00104011 Heitmuller, T. (1975) Acute Toxicity of Gold Crest C-50 to Pink
Shrimp (Penaeus duorarum) and Fiddler Crabs (Uca pugilator).
(Unpublished study received Jun 4, 1975 under unknown admin.
• no.; prepared by Bionomics—EG & G, Inc., submitted by Velsicol
Chemical Corp., Chicago, IL; CDL:132068-A)
00104014 Bentley, R. (1974) Acute Toxicity of Gold Crest C-50 to Rainbow
Trout (Salmo gairdneri). (Unpublished study received Jun 4,
1975 under unknown admin, no.; prepared by Bionomics, EG & G
Environmental Consultants, submitted by Velsicol Chemical Corp.,
Chicago, IL; CDL:132068-D)
130
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OFFICE OF PESTICIDE: PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Chlordane Standard
MRID CITATION
00104015 Bentley, R. (1974) Acute Toxicity of Gold Crest C-50 to Bluegill
(Leponis macrochirus). (Unpublished study received Jun 4, 1975
under unknown admin, no.; prepared by Bionomics, EG & G Environ-
mental Consultants, submitted by Velsicol Chemical Corp.,
Chicago, IL; CDL:132068-E)
00107419 Fink, R.; Beavers, J.; Brown, R. (1978) Final Report: Eight-day
Dietary LC50—Mallard Duck: Technical Reference Standard
Chlordane: Project No. 107-184. (Unpublished study received
Aug 15, 1978 under 876-63; prepared by Wildlife International,
Ltd. ana Washington College, submitted by Velsicol Chemical
Corp., Chicago, IL; CDL:234639-A)
00107420 Fink, R.; Beavers, J.; Grimes, J.; et al. (1978) Final Report:
Eight-day Dietary LC50—Bobwhite Quail: Technical Reference
Standard Chlordane: Project No. 107-182. (Unpublished study
received Feb 28, 1979 under 876-273; prepared by Wildlife Inter-
national, Ltd. and Washington College, submitted by Velsicol
by Monsanto Co., Washington, DC; CDL:248053-D)
00108085 Bentley, R. (1974) Acute Toxicity of Gold Crest Termide to Bluegill
(Leponis macrochirus). (Unpublished study received Jan 29, 1975
under unknown admin, no.; prepared by Bionomics, EG & G Environ-
mental Consultants, submitted by Velsicol Chemical Corp.,
Chicago, IL; CDL:131013-A)
00109564 Probst, G.; McMahont, R.; Hill, L.; et al. (1981) Chemically-in-
duced unscheduled DMA synthesis in primary rat hepatocyte
cultures: A comparison with bacterial mutagenicity using 218
compounds. Environmental Mutagenesis 3:11-32. (Also in unpub-
lished submission received Aug 11, 1982 under 524-285;
submitted by Monsanto Co., Washington, D.C.; CDL:248053-D)
00123771 Epstein, S.; Arnold, E.; Andrea, J.; et al. (1972) Detection ot
chemical mutagens by the dominant lethal assay in the mouse.
Toxicology and Applied Pharmacology 23:288-325. (Also in unpub-
lished submission received 1972 under 4G1438; submitted by Chev-
ron Chemical Co., Richmond, r^; CDL:093832-V)
131
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlordane Standard
MRID CITATION
GS0173-002 U.S. EPA (1972) Pesticidal Aspects of Chlordane in Relation to Man
and the Environment. Unpublished report prepared by Special
Pesticide Review Group. 149 p.
GS0173-004 U.S. EPA (1985) Carcinoyenicity Risk Assessment for Chlordane
and Heptachlor/Heptachlor Epoxide. Unpublished report
prepared by Carcinogen Assessment Group. 138 p.
GS0173-006 Felkner, I. (1986) Overview: Chlordane Metabolism in Maimals.
EPA Contract No. 68-02-4225. Dynamac Corp., No. 1-058.
Unpublished review February 7, 1986. 35 p.
GS0173-OU7 Mauer, I. (1986) The Mutagenicity Assessment (Gene-Tox Profile)
of Chloraane: Addendum to the Registration Standard.
Memorandum to Henry Spencer dated November 25, 1986.
30 p.
GS0144-012 Johnson, W.; Finley, M. (1980) Hanobook of Acute Toxicity of
Chemicals to Fish and Aquatic invertebrates. USDI Publication
137, Washington, D.C.
132
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V. FORMS APPENDICES
133
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1*31-831
FIFHA SECTION 3(C)(2MB) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAMS
APPLICANT* MAM6
DATE GUIDANCE DOCUMENT ISSUED
Mnt * Mbott >Mri«" tea taioori by tta FIFHA action 3(C)(2)(B) not** nnanid m Uu rdwawl
Dl. l«d
ua
hi tfM ««pani o< E«p«t Groupi IB *• CMBJC^I G
-------
OMB Aooronl No. 20004)468 (ExeinK 12-31-93)
CERTIFICATION OP ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
m. fm^utti .i-ui-TLijif f ihj. •J_i_i u i ftM DEVELOPMENT OP DATA
1. 1 am duly autfwrized to rapreiant the following firmfel who ara wbitct to the require-
NAeMtOtVPimft
—
GUIOANCS OOCUMINT OATS
ACTIVSi INOMBOIINT
(PA COMPANY NIMBIR
(This firm or group of firm* i« iefe»ed to below a* "my firm".)
2. My firm a willing to develop and submit the dra at required by that Notice, if neeasHry. However, my firm would prefer to antar
into an agreement with one or more other registrant! to develop jointly, or to share in the cost of developing, the following required
items or data:
1 My firm naa offtrtd in writing to mnr into such in agnomen. Capias of tne orfirs are anacnid. That off ir was irrevocable and mcludtd an off«r to ba
Bound by an arbitration dnmon under FIFBA Steoon 3(cj(21(8)(iii) if final aoraenitnt on all nrnis could not ba rticntd ottisrwio. Ttiit otitt was made
to mi following firm(s) on the following oatais):
MAMS Of FIRM
DATE OF OFFER
-
HovvC'.ar none of (hose fn paragraph |2) joove .n aecore'ance wic^ the Notice. ! unrteruand EPA will oromoriy inform
.-.* ..ni-'"sr .l£ 1 SIGNATURE
i
OATE
£?A Fmm 833O-8 I10-«l
135
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EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
$158. 120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Soiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pH
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
.
»
136
-------
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
Stability
Oxidi zing/ r educi ng
reaction
Flammability
Explodabili ty
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
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
137
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FORMuIATOR'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 foe 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
name, the source of the active ingredient(s) listed in paragraph (1).
(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 Form No. 8570-4. The registered source(s)
of the active ingredient(s) listed in paragraph (1) is/are listed below:
Active ingredient Source; Product name and Reg. No.
Signature
Date Title
EPA Form (April 1985)
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