x>EPA
United St*t«
Environmental Protection
Agency
Off ice of
Peicicidee tnd Toxic Sutoetanoe*
WMhington DC 20460
December 1986
Poiticidw
Guidance for the
Reregistration of
Pesticide Products
Containing Heptachlor
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
AS THE ACTIVE INGREDIENT
HEPTACHLOR
EPA CHEMICAL CODE NO. 044801
Case No. 0175
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, .D.C. 20460
December 31, 1986
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical Covered by this Standard 4
A. Description of Chemical
B. Regulatory History
C. Use Profile
III. Agency Findings 11
A. Summary
B. Preliminary Health Risk Assessment
C. Environmental Profile
0. Additional Considerations
E. Tolerances and Action Levels
IV. Regulatory Position and Rationale 29
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
0. Required Labeling
V. Products Subject to this Standard 50
VI. Requirement for Submission of 'Generic Data 52
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 ch.an.ge in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cance Hat ion
VII. Requirement for Submission of Product-Specific Data . . 57
VIII. Requirement for Submission of Revised Labeling 58
IX. Instructions for Submission 59
A. Manufacturing use products (sole active)
R. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES 62
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES 86
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 113
IV. BIBLIOGRAPHY APPENDICES 124
Guide to Bibliography
Bibliography
V. FORMS APPENDICES 129
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 FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring 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 request1, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
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.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses (See
Section IV - Regulatory Position and Rationale). Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. 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 actions, 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 (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical/ toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. 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: Heptachlor
Chemical nane : 1,4, 5,6,7 ,8 , 3-heptachloro-3a, 4 ,7 ,7a-tetra-
hydro-4,7-msthano-lH indene
Other names: 1,4,5,6,7,8 ,8-heptachloro-3a, 4,7 ,7a-tetra-
hydro-4,7-methanoindene; E-3314; Velsicol 104;
Heptagran; Heptalube; heptachlore; Drinox H-34;
Gold Crest H-60; Heptamul; and Heptox
CAS Registry number: 76-44-8
SPA Pesticide Chemical Code (Shaughnessy) number: 044801
Empirical Formula: CioH5Cl7
Molecular veiqht': 373.3
Chemical/Phys ical
Characteristics: Color: white (pure); light tan (technical)
Physical state: crystalline solid
Odor: mild • camphor-like odor
Melting point: 95-96°C
Boiling point: 135-145°C at 1-1.5 mmHg
Solubility: practically insoluble in water,
but soluble in ethanol, xylene,
carbon tetrachloride, acetone,
and benzene
Density: 1.65-1.67 g/ml at 77°C (pure);
1.65-1.67 g/ml at 65°C (technical)
Vapor pressure: 0.0003 mmHg at 25°C (pure);
0.015 mmHg -at 65°C
(technical)
Stability: stable in daylight, air,
moisture/ and moderate heat
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B. REGULATORY HISTORY
Heptachlor was first registered for use in the United States
under the early FIFRA in 1952, and was produced commercially
the following year. It was used extensively until the 1970*s
as a broad spectrum insecticide on a wide variety of agricultural
crops, with the major use on corn. It also had other non-
agricultural uses including seed treatment, home and garden uses,
and termite control.
In 1974, the EPA Administrator proposed cancellation of nearly
all registered uses of heptachlor and chlordane (a structurally
related cyclodiene insecticide whose regulatory history closely
parallels that of heptachlor's) for reasons that included the
cancer risks posed by both compounds and their persistence and
bioaccumulation throughout the food chain. Human monitoring
data collected between 1970 and 1972 showed heptachlor epoxide
(heptachlor's major degradation product) and oxychlordane (a
metabolite of chlordane) present in the adipose tissue of a
vast majority of the American people; heptachlor epoxide was
found to be present in a substantial percentage of human
milk samples and in stillborn human fetuses and neonates,
indicating a placental transfer from mother to child (39 PR
41298).
All heptachlor 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 field corn, seed treatment (for corn,
wheat, oats barley, rye, and sorghum), citrus, pineapple and
narcissus bulbs, were phased out gradually over a five year
period of time ending on July 1, 1983. Limitations on production
and distribution of technical heptachlor for each phased-out use
were imposed (PR Notice 78-2).
Tolerances for heptachlor were not revoked at the time of can-
cellation 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 December 11, 1985
(50 FR 50643), EPA published a proposed rule under the Federal
Food, Drug, and Cosmetic Act (FFDCA) to revoke all tolerances for
residues of heptachlor in or on food and feed commodities. The
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final rule is scheduled for publication in the Federal Register
in early 1987. There are also several existing action levels
for heptachlor 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 heptachlor, EPA is recommending
that most of these existing action levels be lowered (see section
III.E of this Registration Standard).
Certain uses of heptachlor were specifically exempted from EPA's
suspension and cancellation actions because they were believed to
result in insignificant exposure and, consequently/ insignificant
risk. Registrations were retained for subsurface termite control,
fire ant control in buried cable closures, and dipping of roots
or tops of non-food plants? a use which was subsequently cancelled
voluntarily at the request of the registrant. Under the Admin-
istrator's clarification notice of July 14, 1975, above ground
use of heptachlor 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 heptachlor 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 heptachlor 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
termiticides 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,
pentachlorophenol, and chlorpyrifos) as well as chlordane.
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In summary, the Agency found that the benefits of the termitic ides,
particularly the chlorinated cycledienes (chlordane, heptachlor,
aldrin, and 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 termiticides 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 heptachlor is as
follows:
Preliminary results from the 90-day pilot phase of the hepta-
chlor indoor air monitoring study have been submitted. EPA
has requested that the registrant submit certain data including
gas chromatography-mass spectroscopy (GC-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. No further metabolism testing is
required. The mutagenicity data requirements have not been fully
satisfied, and additional mutagenicity studies are being required
under this Standard. The registrant submitted a subchronic
inhalation study which is considered invalid because the wrong
technical was used (chlordane), and the lowest dose tested in
the study was 20 times higher than the National Academy of
Science (NAS) airborne guideline of 0.005 mg/m3, the lowest
dose level requested by the Data Call-in. A new inhalation
study for heptachlor 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
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for ambient water concentrations of heptachlor. EPA issues
such criteria under section 304(a) o^ the Clean Water Act, which
requires the Agency to publish criter'ia for water quality
reflecting current scientific knowledge on the kind and extent
of all identifiable effects on health and welfare which may be
expected from the presence of 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 for heptachlor
and its supporting scientific assessment Ls described in a
1980 document, "Ambient Water Quality Criteria for Heptachlor.
(EPA 440/5-80-052)," 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) for protection of fresh-water and salt-water
aquatic life from acute toxic effects of heptachlor, and (2)
for protection of human health due to exposure to heptachlor
through ingestion of contaminated water or contaminated aquatic
organisms.
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C. USE PROFILE
The basic producer of heptachlor in the United Sates is Velsicol
Chemical Corporation. In 1980, heptachlor, with some usage as
a single active ingredient, but typically formulated with chlor-
dane, accounted for approximately 15 percent (less than 2
million pounds of active ingredient) of the overall use of
termiticides in this country. In 1985, the usage declined to a
range of 0.75 to 1.0 million pounds of active ingredient. No
usage information is available for heptachlor's minor uses.
There are twenty-two federally registered end-use products
containing heptachlor as the sole active ingredient1/. With the
exception of one granular product, these are all emulsifiable
concentrate (EC) formulations. Six EC end-use products contain
heptachlor in combination with chlordane. In addition, one
end-use product contains heptachlor in combination with penta-
chlorophenol. This product is a restricted use pesticide.
Velsicol Chemical Corporation produces four formulation
intermediates (three of which are heptachlor/chlordane
combinations) and four (72%) technical products. There is one
"special local need" registration under FIFRA section 24(c)
issued to the State of California (CA-810012). All intrastate
products are cancelled.
Heptachlor is registered for control of subterranean termites
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" registration allows for limited use of a chlordane/heptachlor
product in crawl spaces where conditions do not permit trenching
or rodding; application cannot be made more than 18 inches,
horizontally, from the foundation, piers or pipes, and certain
structures cannot be treated (i.e. houses with gravity type
heating systems).
The Agency considers all currently registered end-use
products containing heptachlor in combination with
solvents or diluents to be sole active ingredient formula-
tions. 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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Heptachlor, formulated as a five percent granular product, is
registered for control of fire ants in buried pod mounted
electric power transformers and cable television and telephone
pedestals. Treatment consists of applying the product directly
into the buried cable closure. Heptachlor, formulated in
combination with pentachlorophenol, is a restricted use
pesticide for the above ground preservative treatment of poles
and stubs, timber structures, cuts and holes in treated
wood, and exposed timber and lumber surfaces in buildings to
control fungi, carpenter ants, wood-destroying beetles and
termites. Application to wood surfaces is made by caulking
gun, trowel, or brush. The product is not intended for general
treatment of finished buildings.
The majority of heptachlor end-use products are labeled for use
only by commercial pest control operators. In most States the
applicator must be certified under 40 CFR 171.4 as a commercial
applicator of pesticides.
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III. AGENCY FINDINGS
A. SUMMARY
The Agency has reviewed all data currently supporting the
registration of heptachlor. Based on the available data,
EPA has reached the following conclusions. The points
summarized below are presented in further detail, in the
context of EPA's .science findings and .additional data
requirements, in Sections 3 through D.
1. Technical heptachlor (74%) is moderately acutely toxic
through the oral route of exposure. Additional data are
required to fully assess the acute oral, dermal, and
inhalation toxicity of this pesticide, as well as the
subacute inhalation toxicity.
2. The Agency has concluded that the available data do not
indicate that heptachlor causes acute delayed neurotoxic
effects.
3. Heptachlor and heptachlor epoxide exposure may pose a
significant health risk of chronic liver effects to
occupants of structures treated with heptachlor.
4. The termiticide use of heptachlor may also pose an onco-
genic risk of regulatory concern. Heptachlor and heptachlor
epoxide are oncogenic in laboratory mice; the available
test data in rats are inconclusive for assessing the
oncogenicity of heptachlor/heptachlor epoxide in the rat.
Thus, a new two-year rat oncogenicity study will be required.
Evidence of oncogenicity is based on findings of increased
incidence of liver carcinomas in C3H, CD-I and B6C3Fi
mice, in both males and females, and at both medium and
high doses. EPA will consider the forthcoming results of
the indoor air monitoring study now underway to determine
whether human exposure from the termiticide use of heptachlor
results in risks of cancer and chronic liver effects that
warrant regulatory action. The final results of this
monitoring study are scheduled for submission to the
Agency in February, 1987.
5. The Agency was recently apprised of three reported cases
of optic neuritis (an inflammation of the optic nerve)
associated with termiticide treatment of homes. To
determine whether this human health effect is significant
and whether heptachlor may play a role, the registrant
must have eye tissue from the required two-year
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rat oncogen!city study analyzed by neuropathologists
specializing in optic tissue pathology. Since this study
utilizes animals exposed via the 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 by this type of exposure.
6. Laboratory data show that technical heptachlor is very highly
toxic to warm- and cold-water fish species,, and to freshwater
invertebrates. Heptachlor is highly toxic to birds, based
on acceptable acute dietary studies. Avian acute oral
toxicity data are required.
7. The pesticide chlordane, a related cyclodiene termiticide,
has been found in fish at levels exceeding the U.S. Food
and Drug Administration action level at various urban
aquatic sites in Iowa, Missouri, and Nebraska. Preliminary
evidence indicates the source of this contamination may
be surface water run-off from the termiticidal use of
chlordane. These preliminary findings on chlordane raise
the question whether the termiticide use of heptachlor
could be contaminating surface water. Chlordane has
similar physical and chemical properties to heptachlor;
technical chlordane typically consists of 10 percent
heptachlor.
Therefore, the Agency is requiring a special study
to determine whether heptachlor's use as a termiticide may
result in contamination of surface water. This study is
intended to provide information on (1) whether the termiticide
use of heptachlor results in residues of heptachlor and
its epoxide 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 heptachlor/
heptachlor epoxide as a result of the termiticide use of
heptachlor.
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 heptachlor termiticide
products to Certified Applicators as specifically defined
in label provisions prescribed by EPA in this Registration
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 mis-
application of heptachlor termiticide products (refer
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to Section III.D). The Agency believes that restricting
its use would minimize inadvertent misuse and/or
misapplication.
10. The Agency is restricting the use of the heptachlor
five percent granular product registered for control
of fire ants in buried pod mounted electric power
transformers and cable television and telephone pedestals
due to concern over potential exposure to applicators.
Applicator exposure data are lacking and constitute a
data gap. Restricted-use classification is required as
an interim risk reduction measure until applicator
. exposure data have been received and evaluated.
11. In ratSr the available data from five existing carcino-
genicity studies are not considered adequate or conclusive,
and a well-designed study in rats is needed to determine
the carcinogenic potential of heptachlor epoxide in this
species.
12. Although negative for mutagenic activity in bacteria,
further testing in mammalian systems must be submitted
to complete requirements for mutagenicity, specifically;
mammalian cell gene mutation assays and somatic cell
cytogenetic assays. Additional testing for promotional
(epigenetic) activity is also required.
As a result of this Registration Standard review, the Agency
has determined that certain additional or revised label
restrictions are necessary. These include:
Restricted use classification
Revision of Existing Use Instructions
Pesticide disposal procedures
Worker protective clothing statements
Fish and wildlife toxicity warnings
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 heptachlor as a termiticide. These data must be developed
in order to maintain registrations of existing products or
register any new products containing heptachlor. 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.
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EPA will continue to evaluate the termiticide use of heptachlor
in terras 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 heptachlor and also
its potential oncogenicity and determine whether additional
regulatory action is warrented.
The Regulatory Position and Rationale section of this Registra-
tion Standard discusses the Agency's position on each of the
regulatory issues concerning heptachlor, and the Reguired
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 reguirements)
Toxicology
Battery of acute toxicity studies
Subchronic Inhalation Study — rats (one-year)
— guinea pigs or rats (two-weeks)
Chronic Feeding — non-rodents and rats (heptachlor epoxide);
non-rodents (heptachlor)
Oncogenicity — rats (heptachlor epoxide)
Mutagenicity studies
Teratogenicity — rats and rabbits
Optic tissue pathology -- rats
Environmental Fate/Exposure
Hydrolysis study
Aerobic and anaerobic soil metabolism studies
Aeco'bic aquatic Ttetabolism study
Leaching and adsorption/desorption study
Soil dissipation: field study
Photodegradation in water
Special monitoring study of heptachlor residues entering surface water
from sanitary sewers, sumps/ and drainage tiles from home
foundations known to have been properly treated with heptachlor
Applicator exposure studies
Indoor air exposure studies
Fish and Wildlife
Avian acute oral toxicity
[Pending results of the surface water special monitoring study and
other environmental fate data, additional fish and wildlife data
requirements may be imposed. These include, but are not limited
to monitoring of residues of heptachlor in aquatic sites and
chronic fish and wildli fe .toxicity studies.]
Product Chemistry
All product chemistry studies
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B. PRELIMINARY HEALTH RISK ASSESSMENT
Numerous data gaps exist for heptachlor and few definitive
conclusions can be made pending receipt o£ 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 heptachlor. Additional studies
are required on acute oral, dermal/ and inhalation toxicity.
Based on acute oral toxicity testing using a 74 percent
technical grade of heptachlor/ heptachlor was found to
produce moderate toxicity. The oral LDso value for male and
female rats was reported to be 208 mg/kg and 158 mg/kg,
respectively, placing a 74 percent technical heptachlor in
Toxicity Category II for oral exposure. No data gap
exists for acute oral toxicity testing of manufacturino-
use products containing this percentage of technical grade
heptachlor; a data gap exists for other manufacturing-use
products.
Reported signs of acute intoxication are similar to those
for the other cyclodiene pesticides, and are nrimarily
related to the central nervous system (CNS). Symptoms
include hyperexcitability , convulsions, depression, and
death. There have been numerous incidents of acute intoxica-
tions in humans from heptachlor exposure among chemical
plant workers; however, recovery has been complete and
relatively rapid following removal from the exoosure area.
Based on available data including direct human evidence
from these incidents, and the dissimilarity of heptachlor
to known neurotoxic agents (i.e., organophosphates), the
Agency concludes that based on the available data, heptachlor
does not appear to cause acute delayed neurotoxic effects.
For this reason, a delayed neurotoxici ty study is not
required.
The Agency also concludes that heptachlor 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 sensitiza tion studies
under laboratory conditions without experiencing dermal
sens itiza tion.
However, product-specific data are required so that EPA
may assess the potential of heptachlor products to cause
primary eye and dermal irritation. The purpose of the
requisite primary dermal irritation testing is to determine
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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 heptachlor
products. Acceptable data on file place a 72% technical
heptachlor product in Toxicity Category IV (mildly irritating)
for primary dermal irritation; data gaps exists for other
formulations.
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 heptachlor in February 1984. The registrant
submitted a study which centered on the use of chlordane with
only about 10 percent of the test material being heptachlor.
Thus, it is not possible to discern whether the toxicity
noted in the study results from exposure to chlordane or
heptachlor. The study is considered invalid for this
reason and also because the lowest dose tested was not the
National Academy of Science (NAS) guideline, as requested
in the Data Call-in (DCI). The Agency has determined that
a new rat inhalation study must be performed for a period
of one year, rather than 90-days, as this exposure period
more likely reflects typical human exposure resulting from
termiticide use. The lowest dose level must be the NAS
guideline level.
In available subchronic feeding studies with rats and mice,
the primary subchronic effects exerted by heptachlor and
its epoxide metabolite were reported to be liver effects;
endoplasmic reticulum hypertrophy, enlarged central
hepatic lobule cells, increased liver weight and liver
lesions. Also noted were increased adrenal and thyroid
gland weights. The subchronic studies on file with the
Agency are considered inadequate to satisfy EPA's guideline
requirements. However, the Agency is not requiring subchronic
feeding studies for heptachlor, since the results from the
chronic feeding studies can be used to assess effects releated
to subchronic exposure.
Pending the results of the required acute dermal toxicity study,
the requirement for a 21-day dermal study is reserved.
The registrant also must conduct additional inhalation
studies of two week duration with either guinea pigs or rats
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to further delineate the irritative capabilities to mucous mem-
branes of heptachlor, formulation solvents, and the combina-
tion (i.e. formulated products.).
3. Chronic Toxicity; Liver Effects and Oncogenicity; Setting
a PAD I
Liver Effects and PADI. Administration of heptachlor in
chronic and subchronic feeding studies in mice and rats
resulted in cellular degeneration and histopathological
changes in the liver known as chlorinated hydrocarbon
insecticide rodent liver (CHIRL). Liver toxicity occurred
.at doses as low as 0.5 parts per million (ppm), equivalent to
0.0125 milligrams per kilogram body weight per day (mg/kg/day) ,
the lowest dose tested in a 60-week dog feeding study with
heptachlor epoxide. Based on this lowest effect level (LED
of 0.0125 mg/kg/day, EPA has calculated a provisional
acceptable daily intake (PADI) level for heptachlor, for
effects other than oncogenicity, of 1.3 x 10~5 mg/kg/day, by
applying a 1,000-fold uncertainty factor. The PADI for
heptachlor is based on the chronic feeding study of heptachlor
epoxide, since this is the major storage metabolite of heptachlor
[a NOEL for heptachlor alone is 3.0 ppm].
The PADI is considered provisional because the existing data
base for heptachlor/heptachlor epoxide is lacking the following
toxicology data: chronic toxicity in rats and dogs, rat
oncogenicity, rat and rabbit teratology, and mutagenicity
studies.
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 heptachlor
and chlordane has been conducted by EPA's Carcinogen Assessment
Group (CAG) in accordance with the Agency's 1984 Proposed
Guidelines for Carcinogen Risk Assessment (49 PR 42694;
November 23, 1984). Based on this assessment heptachlor and
heptachlor epoxide have been classified as Group 82 (i.e,
probable human) carcinogens, with cancer potency estimates
(Q~l*) of 4.5 and 9.1 per mg/kg/day, respectively.
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
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data, chemicals are categorized with regard to their
potential human carcinogenicity. Under EPA's classification
system. Group A, "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 Bj requires some human epidem-
iological evidence, since existing epidemiological
studies of heptachlor provide inadequate evidence of
carcinogenicity due to methodological and data limitations,
EPA does not have reason to classify heptachlor as a
Group A or BI . 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 classified on "limited evidence" from
animal studies. There is also a Group D ("Not Classified")
and a Group C that is reserved for chemicals shown to be
non-carcinogenic in animal and/or human studies.
In classifying heptachlor/heptachlor epoxide as Group 82
carcinogens, the Agency considered all currently availaole
data in both mice and rats. In mice, three long-term
carcinogenicity bioassays of heptachlor and its epoxide
independently conducted by investigators affiliated with
the National Cancer Institute (NCI 1977b), the Food and
Drug Administration (Davis, 1965), and the International
Research and Development Corporation (IRDC, 1973b) are
considered adequate for risk assessment by current scientific
standards. In these studies, heptachlor was found to
produce significant liver tumor responses in three different
strains of mice (C3H, CF^, 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-five existing carcinogenicity
bioassays are not considered adequate or conclusive, and
a well-designed study in rats is needed to determine the
carcinogenic potential of heptachlor epoxide in this species.
However, the available evidence in mice is considered
sufficient laboratory evidence to warrant the classification
of helptachlor as a Group 82, probable human carcinogen.
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Further support for this classification comes from the
available evidence on the carcinogenicity of chlordane,
and the induction of tumors by other chemicals such as
aldrin and dieldrin, which are structurally related to
heptachlor2/.
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, quantitative
determinations were made for ambient air levels of 4
chlordane isomers, trans-nonachlor 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 interpret and
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 about the potential human
health risks of heptachlor based on limited literature
values for ambient air levels of heptachlor/chlordane in
treated homes, coupled with heptachlor epoxide's extremely
low PADI (1.3 x 10~5 mg/kg/day), and high cancer potency
value (Q*~!= 9.1 per mg/kg/day). EPA will be considering
the results of the indoor air monitoring study, once the
validation data are received, together with the evidence
on the oncogenicity of heptachlor to determine whether human
Chlordane, aldrin and dieldrin have also been classified as
Group 62 (probable human) carcinogens, based on significant
tumor responses in multiple strains of mice; and in the case
of chlordane, mice and rats.
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exposure to heptachlor may be posing a human health risk of
regulatory concern.
Mutagenicity Studies. The Agency has reviewed eighteen
published articles, consisting of a total of 32 assays with
technical heptachlor/heptachlor epoxide, some of which were
submitted in response to the February, 1986 Data Call-in
Notice. Of these assays, only 10 were found to be acceptable.
Based on its review, the Agency has reached the following
preliminary conclusions:
a. Heptachlor/heptachlor epoxide does not appear to be mutagenic
in microbial or mammalian cells.
b. Although negative for chromosome damage in germinal assays,
the potential for somatic cytogenetic activity has not been
adequately evaluated.
c. The combined results of DNA repair assays indicate that
heptachlor is not genotoxic in bacterial, yeast, or
mammalian cells.
d. There is evidence suggesting that heptachlor, along 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;, mammalian cell gene mutation
assay with established test systems, e.g. mouse lymphoma
(L5178Y/TK), or Chinese hamster (CHO/V79/HGPRT) cells inter
alia and somatic cell cytogenetic assays, either in vitro or
iH v J-vo• Further, to confirm the potential activity of these
chemicals in indirect (epigenetic) processes, the Agency is
requiring the following: repair in mammalian cell systems,
e.g., primary mouse hepatocytes or established cell lines;
adequately controlled promotion assays, e.g., in cell lines
already initiated (by viral transformation), or exposed to
known active chemical initiators; mammalian cell transformation
in systems with an established data base, e.g., C3H 10 Tl/2,
BALB 3T3, inter alia; assays for mitotic spindle effects (in
vitro or in vivo), and/or involving other cellular mechanisms
(e.g., oncogene activation), inter alia; and assays which can
distinguish effects on replicative S-phase (scheduled) DNA
synthesis from UDS, e.g., in primary hepatocytes from several
species (mouse vs. rat/hamster).
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5. Metabolism Studies.
Heptachlor is metabolized to heptachlor epoxide in biological
systems. In studies with rats, it has been reported that
heptachlor epoxide can be further metabolized to di- and
trihydroxylated derivatives of dihydrochlordene and excreted.
Heptachlor is also postulated to be converted to either
1-hydroxychlordene or 1-chloro-dihydrochlordene via another
metabolic pathway and further metabolized to proposed
excretion products by conjugation with glucuronic acid.
There is not sufficient evidence that the production of the
1-chloro-dihydrochlordene species is a major degradative
pathway of heptachlor. Since only the epoxide of heptachlor
has been reported as the major storage metabolite, further
determination of minor quantities of other possible metabolites
is not warranted. There are no further metabolism testing
requirements.
6. Teratology and Reproduction. A data gap exists in the
area of teratology toxicity testing.
Several reproduction studies have been reviewed by the Agency
and were adequate to set a NOEL of 1.0 ppm .for reproductive
effects to the young, the liver being the target organ of
effect. No further testing is required.
In one study comprised of a limited number of male and
female rats exposed for 7 weeks to heptachlor at dosages
ranging from 1.5 to 10 ppm, exposure of dams or sires
to doses ranging from 7 and 10 ppm resulted in increased
pup death. Reproductive effects were absent in rodents
being tested with heptachlor at 5 ppm and below; the lowest
dose producing adverse reproductive effects (pup
death) appeared to be 7 ppm in rats. A NOEL of 5 ppm was
established.
In another study using a limited number of treated dogs
(4 per sex) heptachlor epoxide was fed in the diet at
1, 3, 5, 7, and 10 ppm. Pups born to dams exposed to
7 and 10 ppm died, and pups born to dams exposed to 3 ppm
exhibited liver effects. An LEL of 3 ppm was established
with a NOEL of 1 ppm based on liver effects.
7. Applicator Risks. Because data on heptachlor, including
surrogate data,are not available to characterize applicator
exposure, the Agency is unable to assess the risks posed
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to pesticide applicators as a result of dermal and respiratory
exposures to heptachlor during application. In order to
evaluate the risks of occupational exposure to heptachlor,
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. With the exception of avian acute
oral toxicity testing, there are no ecological effects
data requirements at this time. Existing data are adequate
to show that heptachlor is potentially very highly toxic
to both warm-water and cold-water fish species. The
results of an acute warm-water fish study show an LC5Q
value of 13 ug/L for bluegill. In cold-water fish, the
value was 7.4 ug/L for rainbow trout. Heptachlor is also
very highly toxic to freghwatar invertebrates on an acute
basis. The 48-hour EC50 for Daphnia pulex, Pteronarcys,
and Orconectes are reported to be 42 ug/L,1.1 ug/L and
0.5 ug/L,respectively. Acute dietary studies provide
sufficient information to characterize heptachlor as
potentially highly toxic to birds. Bobwhite quail,
pheasant, and mallard ducks had dietary LCso values of 92
ppm, 24 ppm and 480 ppm, respectively. The requirement
for the avian acute oral LD5Q test has not been satisfied.
Heptachlor epoxide has been reported to cause adverse
effects in birds. In one .study, it was reported to be
responsible for adult mortality and reduced hatchling
success in Canada geese nesting in the Columbia Basin,
Oregon; the geese were believed to have fed on heptachlor-
treated seed. Productivity of the American kestrel was
also reported to be adversely affected by heptachlor.
Since American kestrels are not seed-eaters, the presence
of heptachlor epoxide in kestrel eggs was linked to
contamination of the food chain. Reduced use of heptachlor
in 1979 in the study area resulted in an immediate lowering
of heptachlor epoxide concentrations in kestrel eggs the
following year.
Besides its inherent toxicity, heptachlor epoxide is
highly lipophilic and bioaccumulates in adipose tissue.
This propensity to bioaccumulate could cause heptachlor
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 heptachlor may be contaminating surface waters
should raise concerns about potential heptachlor exposure
to fish or fresh-water invertebrates, special monitoring
of aquatic sites and chronic fish and wildlife studies
may be required.
Environmental Concentration
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2. Endangered Species. EPA does not have reason to believe that
the termiticide use of heptachlor threatens any endangered
species at this time. Concerns may be raised depending upon
the results of the surface water monitoring study (see below).
3. Environmental Fate. The Agency is unable to fully assess
the environmental fate of heptachlor, because acceptable data
are lacking. However, available supplementary data do indicate
general trends of heptachlor behavior in the environment.
Heptachlor was immobile in both Hagerstown silty clay loam
and Lakeland sandy loam soils based on upward movement
in subirrigated soil columns. Heptachlor incorporated
7.5 cm at 5.6 kg ai/ha into a Rayne silt loam soil
dissipated from the surface 0-23 cm with a half-life of
336-551 days. In field studies using heptachlor
epoxide, an estimated half-life of 5-6 months was determined
for Carrington loam soil. Additionally, in long-term
studies in Beltsville, Maryland estimated half-lives
ranged from 2 to 4 years. In long term experiments in
Hawaii, applications resulting in concentrations of
89-503 ppm declined to 0.68-8.28 ppm heptachlor/heptachlor
epoxide after 7 years. Nearby plots not treated with
heptachlor had residues of 0.33-0.52 ppm after 7 years,
indicating some mobility. Heptachlor 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 heptachlor.
To assess the environmental fate of heptachlor 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 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 t'o determine the extent of surface
water contamination from the termiticide use of heptachlor.
The purpose of this study is twofold: (1) to determine
whether and to what extent termiticide applications are
resulting in residues of heptachlor and its degradate heptachlor
epoxide in drinking water and in fish for human consumption,
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and (2) whether fresh-water fish and invertebrates are at
risk of being exposed to toxic levels as a result of heptachlor's
termiticide use.
This requirement arises from recent findings of the termiticide
chlordane in fish at levels exceeding the U.S. Food and Drug
Administration 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 the termiticidal use
of chlordane. 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 heptachlor could be contaminating surface water. Chlordane
and heptachlor, both of which are chlorinated cyclodiene
pesticides, have similar physical and chemical properties as
well as similar application patterns, and it is reasonable
to expect that they may exhibit comparable behavior in the
environment.
D. ADDITIONAL CONSIDERATIONS; HEPTACHLOR COMPLEXITY OF USE AND
MISUSE/MISAPPLICATION
For the purpose of assessing the human health and environ-
mental risks of heptachlor, as discussed in this.Registration
Standard, EPA has assumed the proper use of heptachlor as a
termiticide in accordance with label directions. However,
reports to EPA have indicated a significant incidence of
misuse and misapplication of heptachlor by professional
and non-professional applicators employing soil injection and
trenching methods.
The data indicate that applicators have inadvertently contaminated
structures while applying heptachlor 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 heptachlor
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 ventilation
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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
may result in unnecessarily high, long-term human exposure to
heptachlor over and above levels that may be anticipated on
the basis of controlled ambient air exposure monitoring.
Additionally, the improper use of heptachlor has the potential
to result in environmental contamination. For these reasons,
considered together with the toxic properties of heptachlor and
its potential to persist and bioaccumulate in the environment
in its epoxidized form, EPA is requiring that heptachlor 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 Improve-
ment 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 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 heptachlor,
tolerances for total residues of heptachlor and its epoxidation
product, heptachlor epoxide, resulting in or on raw agricultural
commodities from application of heptachlor we re established
as listed in 40 CFR 180.104 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 heptachlor1 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 heptachlor, 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 heptachlor under the Federal Food, Drug, and
Cosmetic Act (FFDCA) was published December 11, 1985 (50 FR
50643) 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 all existing action levels be lowered
to 0.02 ppm, with the exception of fish and shellfish to be
retained at 0.3 ppm, and fat of meat from goats, cattle, hogs,
horses, sheep, poultry and rabbits to be lowered from 0.3 ppm
to 0.2 ppm. 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 and shellfish.
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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
heptachlor 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 assess-
ment when adequate validation data have been received and
evaluated. EPA is concerned about the potential human health
risks of heptachlor based on limited literature values for
ambient air levels of heptachlor/chlordane in treated homes,
coupled with heptachlor epoxide's extremely low PADI (1.3 x
10~5 rag/kg/day), and high cancer potency value (Q*~l= 9.1 per
mg/kg/day) . EPA will be considering the results of the
indoor air monitoring study, together with the evidence on
the oncogenicity of heptachlor to determine whether human
exposure to heptachlor 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 heptachlor 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
heptachlor 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 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 enabling
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:
0 Training to include basic information on;
•
a. Application equipment, rates of application, and mixing,
loading, and handling procedures for heptachlor products; •
b. Detailed information on construction elements of the
structures likely to be encountered when applying heptachlor
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
heptachlor, 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;
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o
g. Safety in storage and disposal of heptachlor, heptachlor
product containers, unused heptachlor solution, and
contaminated protective equipment and clothing;
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 training
registration program. Such training materials or
programs must include at least the above listed
elements plus any other requirements which a State
might specify.
Competence demonstrated by; a process or method whereby the
State can determine the person is competent to apply the
product by examination or other methods acceptable to EPA. -
Registration by: a sys±em of registration with the State
after the applicant has demonstrated to the State a satis-
factory level of competence in terraiticide 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 available to
EPA indicate recurring misuse and misapplication of heptachlor
termiticide products by pest control operators. In view
of the potential health hazards associated with exposure
to heptachlor, the Agency is concerned about long-term and
acute exposures which may result from the improper use of
heptachlor. 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
heptachlor over and above levels that may be anticipated
following proper applications. In addition, the misuse of
heptachlor has the potential to result in environmental
contamination.
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For these reasons, the Agency believes that the statutory
standard for registration can be met only if these products
are restricted for sale to and 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 heptachlor. By presenting two options for compliance
with the restricted use requirement for heptachlor, it is EPA's
intent to ensure that heptachlor is competently 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 termitic ide 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 adminis-
trative discretion in 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 heptachlor. EPA believes that, where
a Certified Applicator is not physically present, trained
technicians are less likely to misuse or misapply heptachlor.
The minimum training and registration criteria set forth in
this Registration Standard for State programs are intended to
ensure that all users of heptachlor 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 reg-
istration, the Agency has determined that heptachlor product
labels must be revised to provide specific disposal
procedures.
Rationale; Heptachlor products are acutely hazardous when
discarded, and improper disposal of excess pesticide,
spray mixture, or rinsate may result in risks to human
health and/or environmental contamination. Heptachlor
is very highly toxic to fish and freshwater invertebrates.
It is therefore imperative that effluent containing
heptachlor not be improperly discharged into surface
waters or sewer systems.
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4. Ir. order to meet the statutory standard for continued
registration, the Agency has determined that heptachlor
products must bear fish and wildlife toxicity warnings.
Rationale: Labeling requirements are imposed since
available data indicate that heptachlor is very highly
toxic to warm- and cold-water .fish species, freshwater
invertebrates, and birds.
5. A special monitoring study is required to evaluate whetner
and to what extent surface water contamination may be
resulting from the use ot heptachlor as a termiticide.
Rationale; Heptachlor and its degradate heptachlor epoxide
are persistent in the environment and can bioaccumulate
ir. fish and fresh-water invertebrates-. Human dietary
exposure to heptachlor may occur through consumption ot
contaminated drinking water and fish. In addition,
heptachlor is potentially very highly toxic to fish and
freshwater invertebrates. The physical and chemical
properties of heptachlor are similar to the properties
of chlordane, a cyclodiene termiticide which has been, found
in fish at levels exceeding the FDA action level at
various urban aquatic sites in in-lowa, Missouri and
Nebraska. Preliminary evidence indicates that the source
of contamination may be the termiticidal use of chlordane.
Both chemicals also have similar application patterns,
and it is reasonable to expect that they may have comparable
behavior patterns in the environment.
The Agency is therefore requiring a study, in which sump
pump, drainage tiles and sanitary sewer water, draining trom
home foundations known to have been properly treated with
heptachlor, are sampled tor heptachlor residues. Based on
the results of this study, additional regulatory action
may be warranted.
6. The Agency is requiring the submission ot applicator
exposure data from dermal and respiratory routes of exposure.
Rationale; Additional data are needed to determine whether
exposure to applicators during application of heptachlor
products may be posing significant health risks. Registrants
are referred to Subdivision U ot the Pesticide Assessment
Guidelines for acceptable exposure monitoring methodology.
This Guideline document is publicly available through the
National Technical Information Service (NTIb), Springfield,
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Virginia 22151 (telephone: 703-487-4650). Registrants
must submit appropriate protocols for these exposure studies
within 90 days.
7. In order to meet the statutory standard for continued
registration the Agency has determined that heptachlor 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.
8. The Agency is requiring a new two-year rat oncogenicity study
using heptachlor epoxide. Further, examination of eye tissue
from this oncogenicity study is required to evaluate the
potential for heptachlor to cause optic neuritis in humans
as a result of termiticide treatment of homes.
Rationale; The available oncogenicity test -data for rats are
inconclusive. Therefore, a new two-year rat oncogenicity study
is required to characterize the oncogenic potential of heptachlor
epoxide in this species. The Agency was recently appraised
of three reported cases of optic neuritis in humans associated
with termitlcidal application of a related cyclodiene pesticide,
chlordane. To determine whether this health effect is significant
and whether heptachlor plays a role, the registrant must
have eye tissue from the rat oncogenicity study analyzed by
neuropathologists specializing in optic tissue pathology.
9. Special product-specific subacute inhalation testing is
required to evaluate the respiratory hazards to humans in
structures treated with termiticide products containing
heptachlor.
Rationale; The Agency has received reports from individuals
complaining of upper respiratory problems associated with
termiticidal application of related cyclodiene pesticides.
To investigate the extent of the problem and whether
heptachlor plays a role, the Agency is requiring additional
short-term inhalation studies of two-week duration using
guinea pigs or rats to further delineate the irritative
capabilities to mucous membranes of heptachlor, formulation
solvents, and the combination (i.e. formulated products.).
10. A rat inhalation study must be conducted in which the
test duration is one-year and the lowest dose tested is
the NAS guideline as requested in the 1984 Data Call-in
Notice.
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Rationale; The rat inhalation study submitted by the
registrant in response to the 1984 Data Call-in (DCI)
Notice was considered invalid by the Agency because the
lowest dose tested was higher than the WAS guideline
level, and because the study centered on the use of
chlordane with only about 10 percent of the test material
being heptachlor. The DCI requirement was for a 90-day
test duration; a one-year exposure period is now required
because the longer exposure period should more likely
reflect typical human exposure resulting from termiticide
treatment of homes.
11. Special indoor air monitoring studies are required to
support heptachlor's use on structural wood (above ground);
its perimeter surface treatment in human dwellings for
termite control; and its subsurface injection of heptachlor-
containing cartridges for termite control.
Rationale; In 1984, the Agency issued a Data Call-in
Notice to registrants of products containing heptachlor
requiring a monitoring study of heptachlor air levels in
homes of various construction types treated with heptachlor
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
heptachlor. A study is currently underway. The Agency
is .also concerned over the potential health risks posed
by the use of heptachlor 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 as a perimeter surface treatment in human dwellings
(a 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 each of these unique use patterns.
12. The Agency is requiring that the heptachlor five percent
granular product registered for control of fire ants in
buried pod mounted electric power transformers and cable
television and telephone pedestals be classified as
a restricted-use product.
Rationale; Data on applicator exposure resulting from
this unique use pattern for heptachlor are lacking and
therefore the Agency is unable to evaluate the potential
risks to applicators applying this product to electrical
power transformers and telephone pedestals. Restricted-
use classification is required as an interim risk reduction
measure until applicator exposure data have been received
and evaluated.
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13. In order to meet the statutory standard for continued
registration the Agency has determined that the existing
use directions under the current termiticide LIP for
heptachlor product labels must be clarified in order
to further minimize human exposure and avoid contamination
of the environment.
Rationale; Under the current termiticide LIP questions
have been raised regarding existing use directions pertaining
to soil treatment. Information indicates that certain
treatment procedures and clarification to accommodate
technical and safety aspects of termite control and
minimize exposure to homeowners and applicators is
necessary. Such revisions and precautions make the
treatment instructions more clear, minimize misapplication
and ensure compliance.
14. While data gaps are being filled, currently registered
manufacturing use products (MPs) and end-use products (EPs)
containing heptachlor 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.
15. 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 - Rodents and Non-rodents
83-2 Oncogenicity - Rats
83-3 Teratogenicity - Rat and Rabbit
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
§158.145 Ecological Effects
71-1 Acute Avian Oral Toxicity
§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 heptachlor^/. Registrants
of heptachlor 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 heptachlor 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
heptachlor must be labeled for formulation into end-use
products only for subterranean termite control, above ground
wood preservative treatment for the control of wood-destroying
insects, or for fire ant control in buried cable closures.
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 heptachlor 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 heptachlor may
be released for shipment by a registrant or producer of that
product 12 months after the registrant's or oroducer's receipt
of this Registration Standard, unless the product bears an
EPA-ap proved amended label which complies with this Registration
Standard.
No end-use or manufacturing -use product containing heptachlor
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-ap proved 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 acutely hazardous. Improoer 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."
2. Manufacturing-use Products - All manufacturing-use products
must bear the following statements:
"
For formulation into end-use insecticide products intended
only for subterranean termiticide use, above-ground structural
wood treatment for control of tetmi tes and other wood-destroying
insects, and for fire ant control in buried cable closures."
"This pesticide is toxic to fish and wildlife. Do not discharge
effluent containing this oroduct into lakes, streams, ponds,
estuaries, oceans, or public waters unless this product is
specifically identified and addressed in an NPDES permit. Do
not discharge effluent containing this product to sewer systems
without previously notifying the sewage treatment plant
authority. For guidance contact your State Water Board or
Regional Office of the EPA."
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"The use of this product may be hazardous to your health.
This product contains heptachlor, 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:
"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."
4. End-use Products Labels for end-use products bearing
use directions for subterranean termite control and
above-ground structural wood treatment for control of
termites and other wood-destroying insects must be revised
to include the f-ollpwing statements:
"Do not apply heptachlor 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."
"RESTRICTED-USE PESTICIDE
The use of this product may be hazardous to your health.
This product contains heptachlor, 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
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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 supervision
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 wh-ich meets EPA minimal requirements
in termiticide application and must be registered for
termiticide application in the State in which the uncertified
applicator is working."
"Do not apply heptachlor to plenum houses "(houses where the
crawlspace beneath the building is used to circulate heated
or cooled air without ductwork) ."
Labeling for end-use products bearing use directions for
subterranean termite control and above-ground structural wood
treatment for control of termites and other wood-destroying
insects must be revised to include the following information.
(Note: The following is a revision of the current LIP
use directions. Each revision/change to the current LIP is
italicized 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 a-nd 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 Housing
Administration specifications for further guidance.
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PRECONSTRUCTION SUBTERRANEAN TERMITE TREATMENT
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 wails 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 WALLS
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 trie 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
piugged.
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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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 appj.y 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 rodding 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 not 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 che 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.
A8(a)
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5. End-use Products Labels for the end-use product (5%G)
intended for fire ant control in buried cable closures
must bear the following statement:
"Restricted use Pesticide
The use of this product may be hazardous to your
health. This product contains heptachlor, 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 following all use directions
and precautions, and by wearing the protective clothing
specified elsewhere'on this 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 certification."
49
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and 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 formulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
* 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 formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the data
requirements listed in Table C.
3 if you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
. Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
Data requirements.
51
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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.
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If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standardi you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's 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 DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
53
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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 isuch 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 OCI 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.
54
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5. You request that EPA amend your registration by deleting
fehe 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,
55
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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.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section IV.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data)
or IV.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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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.
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IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing Heptachlor
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.)
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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 Heptachlor 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
attachmentsS (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 Heptachlor alone**/ 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 reguired
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.
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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.
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I. DATA APPENDICES
62
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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 fables 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
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
N/A = Data requirement not applicable to the use pattern
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
0 = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
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TGUIDE-2
Any other designations will be defined in a footnote to the table.
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
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 £.
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 receipt 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.
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TABl£ A
GENERIC DATA REQUIREMENTS K)R
Data Requirement
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and Dis-
closure of Ingredients
61-2 - Description of Beginning
Test
Substance
TGAI
TGAI
Use Does EPA Bibliographic Must Additional
Patterns Have Data?^/ Citation J/ Data be
Submitted?
6,H,I Yes
B,H,I Yes
Timeframe
for
Submission2/
6 Months
6 Months
Materials and Manufacturing
Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of
TCAI
B,H,I
Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limit
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
TGAI
TGAI
TGAI
TGAI
TGAI
•KJAI
B,H,I
B,H,1
B,H,1
B,H,I
B,H,I
B,H,I
Yes
Yes
Yes
Yes
Yes
Yes
Yes
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
65
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TABLE A
GENERIC DATA REQUIREMENTS tOK
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?}/ Citation V Data be for
Submitted? Submission2/
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
(continued)
63-5 - Melting Point TGAI B,H,I
63-6 - Boiling Point TGAI B,H,1
63-7 - Density, Bulk Density, or TGAI B,H,I
Specific Gravity
63-8 - Solubility TGAI or PAI B,H,I
63-9 - Vapor Pressure PAI B,H,I
63-10 - Dissociation Constant PAI B,H,I
63-11 - Octanol/Water Partition PAI B,H,I
Coefficient
63-12 - pH TGAI B,H,I
63-13 - Stability TGAI B,H,I
Other Requirements:
64-1 - Submittal of Samples TGAI, PAI B,H,1
\
Yes
NoV
Yes
Yes
NoV
Yes
Yes
Yes
Yes
Reserved V
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 tor 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 heptachlor is a solid at room temperature.
4/ Not required because the melting point of the pure tomi is >30° C.
$/ It samples are needed, the Agency will request them.
66
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR HEPTACHLDR
Data Requirement • Test Use Does EPA Bibliographic Must Additional Timefrante
Substance Patterns Have Data? Citation Data be for
Submitted? Submission3/
§158.130 Environmental Pate (continued)
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES-FIELD;
164-1 - Soil
164-2 - Aouatic (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
TEP
TEP
PAIRA
TEP
N/A
N/A
B,H
H
N/A
N/A
N/A
N/A
N/A
TEP N/A
TGAI or PAIRA H
No
No
Yes
27 MonthsV
(8 Months- Progress
Report)
Reserved V
No
Reserved
3/
-------
TABLE A
GENERIC DATA REQUIREMENTS fOR HEPTACHLQR
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional
Citation Data be
Submitted?
Timeframe
for
Submission*/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradation
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;
163-1 - Leaching and
Adsorpt ion/Desdrpt ion
TGAI or PAIRA B,H
TGAI or PAIRA H
TGAI or PAIRA N/A
TGAI or PAIRA N/A
TGAI or PAIRA B,H
TGAI or PAIRA B,H
TGAI or PAIRA B,H
TGAI or PAIRA H
TGAI or PAIRA B,H
No
No
No
No
No
No
No
Yes
YesV
9 Months
9 Months
Yes
YesV
Reserved3/
Yes3/
Yes
27 Months^/
(8 Months - Progress
Report)
27 Months^
(8 Months - Progres
Report)
27 Months^
(8 Months - Progreb
Report)
12 Months
68
-------
TABLE A
GENERIC DATA REQUIREMENTS l-OR HEPTACHLOR
Data Requirement
Test
Substance
Use
Pattern
Does EPA Have
Data?
.bibliographic
Citation
Must Additional
Data be Submitted?
§158.130 Environmental Fate (continued)
165-5 - In Aquatic Nontarget TEP
Organisms
Timeframe
for
Submission1/
N/A
MONITORING STUDIES;
Water Monitoring Study
EXPOSURE STUDIES:
Applicators
Residents- Indoor Air
Monitoring Study-
Velsicol's Ongoing Study
TEP
No
YesV
TEP
TEP
No
No
YesV
15 Months
(90 Days- Acceptable
Protocol )
(8 Months- Progress
Report )
6 Months
(90 Days- Acceptable
Protocol )
(Final Report-
February, 1987)
Residents- Indoor Air
Monitoring Study-
Above Ground Use in Structural Wood
TEP
No
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, a related cycloliene pesticide, in urban water systems,
presumably from termiticide uses, additional data requirements have been imposed, which will focus on
the fate of heptachlor in the aquatic environment. These are: photodegradation in water, anaerobic soil metabolism
and aerobic aquatic metabolism. Aquatic (sediment) dissipation acid anaerobic aquatic metabolism data requirements
are reserved pending results of the aerobic aquatic metabolism studies. Fish residue accumulation data are reserved
pending the results of the octanoL/water partition coefficient studios.
-------
TAbLE A
GENERIC DATA REQUIKUMENTS FOR HEPTACHLQR
§158.130 Environmental Fate (continued)
4_/ A special monitoring study is required, either prospective or retrospective; in which water from sanitary sewers,
sumps, and drainage tiles, draining from home foundations treated with heptachlor, is sampled and analyzed
for residues of heptachlor. An acceptable protocol must be submitted within 90 days of receipt of this Standard.
5/ Applicator exposure data must be submitted to support heptachlor's teuniticide uses (subsurface and above ground)
and it's use in buried cable closures for fire ant control. Acceptable protocols 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 Cail-In program. This study i
currently in progress. Further testing may be required pending the results of this study.
7/ A one-year indoor air monitoring study is required to support registration of products registered for 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 after receipt of this Standard. Interim reports are due semi-annually
thereafter.
70
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR HEPTACHLQR
Data Requirement Test Use Does EPA
Substance Patterns Have Data?
§158.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat TGAI B,H,I Yes . .
81-2 - Acute Deonal Toxicity - TGAI B,H,I No
Rabbit
81-3 - Acute Inhalation Toxicity - TGAI B,H,I No
Rat
81-7 - Delayed Neurotoxicity - Hen TGAI B,H,I No
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding: Rodent
and Nonrodent (Dog) TGAI B,H,I No
82-2 - 21-Day Dermal - Rabbit TGAI B,H,I No
82-3 - 90- Day Dermal - Rabbit TGAI B,H,I No
82-4 - 90-Day Inhalation - Rat TEP B,H,I No
Bibliographic Must Additional
Citation Data be
Submitted?
00050054 No
Yes
Yes
Nc-2/
NoV
Reserved4/
NoV
Nc6/
Time frame
tor
Submission^/
9 Months
9 Months
82-5 - 90-Day Neurotoxicity
TGAI B,H,I
No
NC2/
71
-------
TABLE A
GENERIC DATA REQUIREMENTS bOR HEPTACHLOR
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timetcame
Data be tor
Submitted? Submission1/
§158.135 Toxicology (continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity -
Rodent and Non-Rodent
83-2 - Oncogenicity -
Mouse
Rat
83-3 - Teratogenicity -
Rat and Rabbit
TCAI . B,H,I
TGAI
TCAI
TCAI
B,H,I
B,H,I
B,H,I
Partially GS0175-001
Yes
No
No
YesV
GS0173-004 No
Yes8/
Yes
50 MonthslO
(8 Months- Progres
Report)
50 MonthslO/
(8 Months- Progret
Report)
15 Months
(8 Months- Proyres
83-4 - Reproduction - Rat
2-generation
TCAI
B,H,I
Yes
GS017b-001
No
MUTAGENICITY TESTING;
84-2 - Gene Mutation
84-3 - Structural Chromosomal
Aberration
84-4 - Other Genotoxic Ettects
TCAI B,H,I
TCAI B,H,I
TCAI B,H,I
Partially GS017b-U03
Partially GS0175-003
Partially GS0175-003
YesVU/
Yeslu/l3/
y Months
12 Months
YesU/lV 12 Months
90 Days- Acceptable
Protocol)
72
-------
TABLE A
(iKNKRIC DATA UtiQU I RtMUMTS ttjK HL'PTACHUJR
Data Requicement
Test
Substance
Use
Patterns
Does UPA
Have Data'.-1
UibLiographic
Citation
Must Additional Timetcame
Data be tor
Submitted? Submission^/
85-1 - General Metabolism
SPECIAL TESTING:
Optic tissue Pathology
Rat Inhalation Study
PAI or PAIRA
H,£
Yes
NO
NO
GSO 175-004
Yes&/
To be Determined
24 Months
I/ Due dates retec to the 'number ot months tollowing receipt ot the Utgistration Standard by the registrant, unless
otherwise indicated.
2/ Heptachlor is dissimilar to known delayed neucotoxic agents (i.e., organophosphates) and neurotoxicity ot the delay-
type has not been reported in the large number of chemical plant intoxications encountered. Recovery has been com-
plete and relatively rapid when humans were removed team the exposure area, b'or these reasons, the Agency is not
requiring this test.
V The Agency is not requiring 90-day studies, since Long-term studies supercede the need Lor subchronic studies.
4/ Requirement for submission ot a 21-day dermal study is reserved pending the results ot the acute dermal
toxicity study.
5_/ The Agency recognizes that heptachlor is absorbed dentially and toxicity can ensure tram that exposure. However, th
target organs have been well delineated from other routes ot exposure and therefore, no data are required tor
this area of study.-
6/ A requirement for a 90 day subchronic inhalation study was originally imposed as part ot the Agency's 1984 Data
Call-In Notice. The study submitted to the Agency centered on the use of chlordane with only about 10 pet-
cent ot the test material being heptachlor. The study is considered invalid tor this reason and because the
lowest dose tested was not the National Academy of Science (NAS) guideline, as requested in the DCI. A new
rat inhalation study must be performed in which the test duration is one year, rather than 90-days, as
this exposure period more likely reflects typical human exposure resulting from termiticide use. The lowest
dose level must be the NAS guideline level.
7/ Data gaps exist tor chtonic feeding testing in rodents (rats) and non-rodents tot heptachlor epoxide; and tot:
heptachloc in non-rodents.
73
-------
1~ Ul\ll\ I
S158.135 Toxicology (continued)
8/ A data yap exists foe oncoyenicity testing, in rodents (rats) tot lieptachlor epoxide.
9/ A manmalian cell gene mutation assay, with estabJ ished test systems, e.y. mouse lymphoma (L517bY/"IK), oc
Chinese hamster (CHO/V79/HGPUT) cells inter alia , specifically comparing acyivation systems (S9) derived
trom rat vs. mouse (or hamsten) livec microscmes, is tequiLed
IU/ Somatic cell cytoyenetic assays, either in vitro oc in vivo , ace required.
ll/ The following studies are required:
a. repair in mammalian cell systems, e.g., primary mouse hepatocytes or established cell lines, by autoradio-
graphic oc alkaline elution techniques.
b. adequately controlled promotion assays, e.g., in cell lines already initiated (by vital tcanstocmation),
or exposed to known chemical initiators.
c. mammalian cell transformation in systems with an established data base, e.g., C3H 10 Tl/2, BALB 3T3, inter
alia.
d. assays for mitotic spindle effects (in vitro oc iri vivo), and/ot involving othet cellular mechanisms (e.g.,
oncogene activation), inter alia.
e. assays which can distinguish effects on replicative S-phasu (scheduled) DNA synthesis tron DOS, e.g., in
primary hepatocytes trom several species (mouse vs. rat/hamstet).
12/ The first progress report is due 8 months atter receipt of this Standard. Interim reports are due semi-annually
thereafter.
13/ This requirement was originally imposed as part ot the Agency's 19d4 Special Termiticide Data Call-in Notice.
Data received in response to that DC1 were reviewed in conjunction with the development ot this
Registration Standard and tound to be unacceptable or inconclusive (see footnotes 9,10, and ll).
14/ 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.
lb/ Eye tissue fcom the required Lwo-yeac rat oncoyenicity study must be analyzed by neuropathologists specializing
in optic tissue pathology.
74
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR HEPTACHIDK
Data Requicement
Test Use Does EPA
Substance Patterns Have Data?
bibliographic
Citation
Must Additional Timetcame
Data be • for
Submitted? Submission /
§158.145 Wildlife and Aquatic Organisms
AVIAN AND MAMMALIAN TESTING;
71-1 - Acute Avian Oral Toxicity
B,H,I
NO
Yes
Months
71-2 - Avian Subacute Dietary TGAI
Upland Game Bird and Waterfowl
B,H,I
Yes
OOU85950
No
71-3 - Wild Mammal Toxicity
TGAI
N/A
71-4 - Avian Reproduction TGAI
Upland Game Bird and Watectowl
B,H,I
NO
Reserved^/
71-5 - Simulated Field Testing
and Actual Field Testing -
Mammals and Birds
TEP
B,H,I
No
Reserved2/
72-1 - Freshwater Fish Toxicity
- Warmwater ana Coldwater
Species
- Unique Formulation
(Warmwater Species)
- Unique Formulation
(Coldwatec Species)
TGAI B,H,I
TEP B,H,I
TEP B,H,I
Yes
Yes
Yes
GS0144-012
00108085
00086221
00103b82
00086221
NO
NO
NO
75
-------
TABLE A
GENERIC DATA REQUIREMbWTS' FUR HtPTACHLOR
Data
§158
Requi rement
Test
Substance
Use • Does fcPA
Pattetns Have Data?
Bibliographic Must Additional
Citation Data be
Submitted?
Timef rame
tor
Submission!
.145 Wildlife and Aquatic Organisms (continued)
AQUATIC ORGANISM TESTING:
72-2
72-3
72-4
- Acute Toxicity to
Freshwater Invertebrates
- Unique Formulation
- Acute Toxicity to Estuarine
and Marine Organisms
- Fish Early Life stage,
TGAI
TLP
TGAI
TGAI
B,H,I Yes
B,H,I Yes
B,H,I NO
H,I NO
GS0144-012 No
00086221 No
Reserved2/
Reserved2/
and Aquatic Invertebrate
Life Cycle
72-5 - Fish - Lite Cycle
72-6 - Aquatic organism
Accumulation
72-7 - Simulated field Testing
and Actual Field Testing
- Aquatic Organisms
TGAI H,I
TUAI, PAI or
Degradation
Product
TfcP
H,I
NO
NO
NO
Reserved2/
Reserved2/
Reserved2/
-------
TAtJLE A
GENERIC DATA RETIREMENTS tX)R HEPTACHLOR
Data Requirement Test Use Does hlPA Bibliographic Must Additional Timuframe
Substance Patterns have Data? Citation Data be tor
Submitted? Submission
§158.145 Wildlife and Aquatic Organisms
SPECIAL TESTING
70-1 Aquatic Residue Monitoring H,I No Reserved^/
V Due dates reter to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ This requirement is reserved pending die results of the special monitoring study, in which water from sanitary sewer,
sumps, and drainage tiles, draining from home foundations treated with heptachlor, is sampled and analyzed tor residue
of heptachlor.
77
-------
TABIJi b
PRODUCT SPECIFIC DATA RBgUIREMtWTS- tUR MANUrALTUKJNLr-UtiL; PRODUCTS CONTAINING HEPTACHLQR
Data Requirement
Test Use Does EPA bibliographic
Substance Patterns Have Data.-' Citation
Must Additional Timeframe
Data be tor
Submitted? Submission^/
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat MP '*/ B,H,I PacLially OUOb0054
- Acute Dermal Toxicity MP 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 00066843
- Rabbit
- Dermal Sensitization MP B,H,I No
- Guinea Pig
YesV 9 Months
Yes 9 Months
Yes 9 Months
Yes 9 Months
YesV 9 Months
NqV
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 manutacturing-use products.
3/ Data are satisfied tor a heptachlor technical (74% pure) formulation only.
4/ Due to the extensive human exposure data compiled without reported deunal sensitization, testing is not required.
78
-------
TABLE B
PRODUCT SPfc£IFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING HEPTACHLOR
Data Requirement
Test
Substance
Use Does
Patterns Have
EPA Bibliographic Must Additional Timeframe
Data?V Citation V Data be for
Submitted? 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
MPV B,H,I
MP
MP
B,H,I
Ingredients;
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3- Analytical Methods to Verify
Certified Limit
Physical And Chemical Characteristics:
63-2 - Color
63-3 - Physical State
63-4 - Odor
MP
MP
MP
MP
MP
MP
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
79
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING HEPTACHLOR
Data Requirement Test
Substance
Use Does
Patterns Have
EPA Bibliographic Must Additional Timeframe
Uata?V Citation V Data be tor
Submitted? Submission?/
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
(continued)
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64-1 -
- Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizing or Reducing
Action
- Flanmability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements:
- Submittal of
Samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
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
Reserved4/
7 Months
7 Months
7 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 manufacturing-use product. New requirements have been introduced and previously submitted
data must be updated. Therefore, bibliographic citations for the old data are not applicable.
-------
DATA KfcQUlREMUNTS FOR
§ 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 ot manutacturing-use products.
4/ 1C samples are needed, the Agency will request them.
-------
TABLU c
PRODUCT SPECIFIC DATA HldQU I MOMENTS t'OK END-USE 1JKODUCTS CONTAINING HtlPTACHLOR
Guideline Citation and Name of Test Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have l~Jata?J/ Citation!/ Data be tor
Submitted? Submission2/
§158.120 - Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure EP B,H,1
of Ingredients
61-2 - Description ot Beginning Materials EP B,H,I
and Manufacturing Process
61-3 - Discussion of Formation of EP B,H,I
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis EP B,H,I
62-1 - Certification of Limits EP B,H,I
62-3 - Analytical Methods to Verify EP B,H,I
Certified Limit
Physical and Chemical Characteristics
63-2 - Color EP B,H,I
63-3 - Physical State EP B,H,I
63-4 - Odor EP B,H,I
63-7 - Density, Bulk Density, or EP B,H,1
•
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
82
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS TOR END-USE PRODUCTS CONTAINING HEPTACHLOtf
Guideline Citation and Name of Test Test
Substance
Use Does EPA Bibliographic Must Additional Timeframe
Patterns Have Data?V Citation^/ Data be for
Submitted? Submission?/
§158.120 - Product Chemistry (continued)
Physical and Chemical Characteristics (continued)
63-12 -
63-14 -
63-15 -
63-16 -
63-17 -
63-18 -
63-19 -
63-20 -
63-21 -
pH
Oxidizing or Reducing
Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric Breakdown Voltage
EP
EP
EP
EP
EP
EP
EP
EP
EP
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
B,H,I
BfH,I
H,I
Yes
Yes
Yes
Yes
Yes
Yes .
Yes
i
Yes
NoV
6 Months
6 Months
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
Other Requirements:
64-1
Submittal of Samples EP,TGAI,PAI
B,H,I
Reserved*/
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.
83
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING HEPTACHLOR
§158.120- Product Chemistry (continued)
•
3/ Not required for termiticide products, since product labeling cautions to avoid use near electrical conduits.
4/ If samples are needed, the Agency will request them.
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENT FOU END-USt PRODUCTS CONTAINING HEPfACHLOR
Guideline Citation and Name of Test Test Use 'Does EPA
Substance Patterns Have Data?
§158.135 Toxicology
z
Acute Testing;
81-1 - Acute Oral Toxicity - Rat EP B,H,I No
81-2 - Acute Dermal Toxicity EP B,H,I No
- Rabbit
81-3 - Acute Inhalation Toxicity EP B,H,I No
- Rat
81-4 - Primary Eye Irritation EP BfH,I No
- Rabbit
81-5 - Primary Dermal Irritation EP B,H,I No
- Rabbit
81-6 - Dermal Sensitzation EP B,H,I No
SPECIAL TEST
Guinea Pig or Rat Inhalation Study EP H,I No
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission1/
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
Yes3/
15 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/ Due to extensive human exposure data compiled without reported ••dermal sensitization, testing is not required.
3/ Testing is required to delineate the irritative capabilities to mucous membranes of heptachlor, the solvent,
and/or the combination. The study design must include a 7-day exposure period to two groups og guinea pigs, with
a 2-week recovery in one group; the second to be sacrificed after 7 days of exposure. Exposures should be for
6-8 hrs/day at levels found in a housu on day 1 of termite treatment, and include end-use solvent alone; heptachlor
alone, and solvent plus heptachlor. Registrants of products containing the same or similar solvents are
encouraged to develop data jointly.
H S
-------
II. LABELING APPENDICES
86
-------
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)]
t
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA.establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
.The ingredients statement must run parallel with, and ie clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
87
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SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid" agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together/ preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
•
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 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 i
-------
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.
89
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(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 tor 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.
90
-------
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.
91
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SUMMARY-6
LABELING REQUIREMENTS OF THE FIPRA, 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 Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed 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.
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
SB
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
OP REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal ', or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
' Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word .
Environmental hazards include bee
caution where applicable.
-------
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
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
tor use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction . The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use .
Refer to Appendix 11 guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
.4 OOMESTB AMMALS
CAUTION
ENVKONUEMTAL HAZARDS
PHYSCALORCHEMCAL
HAZARDS
• k •
rf Ndnl to
to • mmm
RE-ENTRV CTATEUiNT
CHOP:.
CROft
P*RODUCT
NAME
ACTIVE MOREOCHT: ,
MERT MMEOCMia:,
TOTAU
100.00ft
TH* PRODUCT CONTAMS IBS OF fEROAUON
KEEP OUT OF REACH OF CHILDREN
CAUTION
•TATUUMT OF PRACTICAL TREATMENT
r SWALLOWED:
-------
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
(• OOUE8TC ANMAL8I
OANOCR
ENVMONMENTAL HAZARDS
PHYSCAL OH CHEUCAl
HAZARDS
CNREOnONS FOR USE
• (MM ft P«*ral k* to
«rpduol to • Mm*
RE-ENTRY STATEMENT
STORAGE AND
' DISPOSAL
STORM
DISPOSAL:
CROP:
RESTRICTED USE
PESTICIDE x
(reason Tor clasr,Ifyinr)
IQR HTtML SCE ID AND IBB OMU BV CCKnnCD APPLICATCR9 0».
R3SCK3 UNCEX THEIR DIRECT SUFCKVISION AW ONLY IOR TMQ6B
IBB9 ODV0CO ST THE CEKTiriCO APPUCATOR'S CERTIPICATICM
PRODUCT
NAME
ACTIVE NOREOCNT: ,
MEMT MOMEMNT8.,
TOTAL:
10000%
THIS PRODUCT CONTAINS IBS OF PER GALLON
KEEP OUT OF REACH OF CHILDREN
DANGER -POISON
STATEMENT OF PRACTICAL TREATMENT
9 SWALLOWED:
*MHALEDS=
f M EVES
SEE 8OE PANEL FOR AOOmONAL PRECAUTIONARY STATEMENTS
MFOBY===
TOWN. STATE =====
ESTABLISHMENT NO. =
EPA REGISTRATION NO.:
NET CONTENTS:
WARRANTY STATEMENT
-------
§ 16110
at obtained the data from
(identify): applicant copied
. a publication: applicant ot
' of the data from EPA).
The applicant shall submit
on a statement
Devaluation of the propertle
safety of the
i product, may not <
supporting the
i following data:
data the
, SPA under i
data
product's
than to the
we and
(3) y-rt«n™* tali
regulations.
Cil
Pood. Drug.
-------
§ 1M.10
lit) The product registration
number as prescribed In paragraph of this section.
<2> Prominence and frrfbim* (I) All
word*. slatementa. graphic representa-
tions, designs or other Information re-
qulrrd on the labeling by the Act or
the regulation* In thb part must be
clearly legible to a person with normal
vision, and must be placed with such
corMplcuousnesa (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed In such terms as to render It
Ilkrly to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(II) All required label text must:
(A) De net In 6-polnt or larger type;
IB) Appear on a clear contrasting
background: and
(C) Not be obscured or ciowded.
13) Xxniffuaor to oe turd. All required
label or labeling text shall appear In
the Engltah language. However, the
Agency may require or the applicant
may propose additional text In other
languages as Is considered necessary to
protect the public. When additional
text In another language 1s necessary.
all labeling requirement* will be ap-
plied equally to both the English and
other-language versions of the label-
Ing.
(4) Placemen! of Label-41) Oenerat
The label shall appear on or be secure-
ly Attached to the Immediate contain-
er of the pesticide product. For pur-
poses of thb Section, and the mls-
brandlng provisions of the Act. "se-
curely attached" shall mean that a
Isbrl can reasonably be expected to
remain affixed during the foreseeable
conditions and period of line. If the Im-
mediate container Is enclosed within a
Title 40—Protection of tnvwonmonl
wiapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer. If It b a part of the package as
customarily dblrlbuted or sold.
car on the front panel of the
label
•2) No name, brand, or trademark
may appear on the label which:
(I) Is false or misleading, or
(II) Ha* not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional nnnte pursunnt to I 163 6(bl(4).
In
terms of liquid measure at 6B" F <2(Tf:>
and shall be expressed In conventional
American units of fluid ounces, pints.
quarts, and gallons.
43) If the pesticide Is solid or semlso-
lid. viscous or pressurized, or Is a mix
lure of liquid and solid, tlip nel con
lent statement shall be In terms of
weight expressed as avoirdupois
pounds and ounces.
<4> fn all cases, net conlcnl shall be
staled In terms of Ihe largest suitable
units. I.e.. "I pound II) ounces" tallirr
than "29 ounces."
(B) In addition to the required units
specified, net content may be ex-
pressed In metric units.
(8) Variation above minimum con-
tent or around an average b permissi-
ble only to the extent thai It repre-
sents deviation unavoidable In good
msnufactuilng pracllce. Variation
below a staled minimum Is nol permit
ted. In no case shall the average con-
tent of the packages In a shipment fnll
below the staled average conlenl.
(e) Product repfifrnffnn numnrr.
The registration number assigned to
Ihe pesticide product at Hie lime of
reglslrallon shall appear on Ihe Inliel.
preceded by Ihe phrase "EPA Regis
tratlon No.." or the phra.se "RPA fteg
No " The registration number shall be
set In type of a alee and style similar lo
other print on that part of the Inlirl
on which II appears and shall run pnr
2R
n f
-------
9 itt.101
•lid to U. The regtotraUon number
and the required Identifying phrase
ahall not appear hi such a manner as
to suggest or Imply recommendation
or endorsement of-the product by the
Agency.
(f) Producing ettabUAmenlt - regit-
tration number. The producing; estab-
lishment regtotraUon number preced-
ed by the phrase "EPA Est". of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package If the EPA establishment reg-
istration number on the Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient ttatement-il) Gener-
al The label qf each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all Inert Ingredi-
ents; and If the pesticide contains ar-
senic In any form, a statement of the
percentages of total and water-soluble
arsenic calculated aa 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 she. be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" b
not required for pesticides which con-
tain 100 percent active Ingredients.
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) Petition oj ingredient statement
(I) The Ingredient statement ta nor-
mally required on the front panel of
the label. U there b an outside con-
tainer or wrapper through whkh the
Ingredient statement cannot be clearly
read, the Ingredient statement must
abo appear on such outside container
or wrapper. If the atae 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.
IHtf
(U) The text of the
inent must run paralld with other
text on the panel on whkh H appears.
and must be clearly dbUngubhable
from and must not be placed ta the
body of other text.
(1) Mamet to be lued to ingredient
ttatemenL The name used for each In-
gredient shall be the accepted
common name. If there b one, fol-
rawejt by the chemical nine. The
common-name may be used alone only
If It b well known. If no common name
has been established, the chemical
name alone ahall be used. In no cose
will the use of e, trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section SMeM*).
(4) Statement* oj percentage*. The
percentages of Ingredients shall be
stated ta terms of welght-to-welght
The sum of percentages of the active
and the Inert Ingredients shall be 100.
Percentages shall not be expressed by
a range of values such aa "33-36%." If
the uses of the pesticide product are
expressed as weight of active Ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pcrtlcldc formulation
ahall abo appear ta the Ingredient
statement
(B) Accuracy o/ stated 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 whkh may be pres-
ent
(•) Deterioration. Pesticides whkh.
change ta chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where It b determined
that a pesticide formulation changes
chemical composlUon significantly.
the product must bear the following •
statement ta a prominent position on
the label: "Not for sale or use after
I date I."
(II) The product must meet all label
claims up to the expiration time Indi-
cated on the label.
(7) Inert ingredient*. The Adminis-
trator may require the name of any
Inert IngredlenUs) to be Ibted ta the
Ingredient statement If he determines
that such tngredlenUs) **Miy pose •
hasard to man or thr environment.
(h> Warning* and precautionary
sfalemenfJL Required warnings and
precautionary statements concerning
the general areas of toxicologies!
hazard Including hazard to children.
environmental hazard, and physical or
chemical hazard fall Into two group*;
those icqulred on the front panel of
the labeling and those which may
S 141. l>
Bpretfle require
_ content, placement
type sbe. and prominence are glvn
(I) Kfantnd front panel statement.
With the exception of the clill
hazard warning statement the text n
quired on the front panel of the lain
b determined by the ToxkUy (tetegf
ry of the pestkldc. The category U ai
signed on .the baab of the hlslir*
hazard shown by any of the Inrikatoi
In the table below.
CktflO.
•in
(I) Hitman hagard tignat awnf- rociclfy Coicoorv II. All pesti-
cide products meeting the criteria of
Toxlclty Category H shall bear on the
front panel the signal word "Warn-
ing."
(C» rorlclry Category III. All pesti-
cide products meeting the criteria of
Toxlclty Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) ToxMtw Categor* IV. All pesU-
cWr products meeting the criteria of
Toxlclty Category IV shall bear on the
front panrl the signal word "Caution."
(E) Vie of tlgnal word*. Use of any
signal wordis) associated with a higher
Toxlclty Category b not
except when the Agency dclrrmlnr
that such labeling b necessary to prr
vent unreasonable advrrar- rffrcts m
man or the environment. In no nm
shall more than one human hasan
signal word appear on the front nanr
ofalabeL
(II) Child hasard warning. Evrry pm
Udde product label shall brar on tin
front panel the statement "keep out o
reach of children." Only In raw
where the likelihood of cnntart will
children during distribution, market
Ing. storage or use b demonstrated hj
the applicant to be extremrly it-mot*
or If the nature of the pesllcldr Li sucl
that It b approved for use on Infant.
or small children, may the Admlnbtm
tor waive this requirement.
(Ill) Statement o/ practical frrat
ment-4Af Toxtcffy Category ' *•
statement of practical treatment (Mm'
aid or other) shall appear on the front
panel of the label of all pMttddr* fall
Ing Into Toxlclty CaUwory I «n tin
baab of oral. Inhalation or dermal to*
Idly. The Agency may. howrvri
permit reasonable variation* In tin
placement of the statement of prarll
-------
§ 161.10
cal treatment Is some reference such
u "Bee statement of practical treat-
ment on bwk panel" appears on tha
front panel near the word "Poison"
and the skull and crossbonea.
The fallowing table depicts typi-
cal precautionary atatementa. These
statements must be modified or ex-
panded to reflect specific haxards.
FoM >iliuiii« S i
•Mil. Oo not I
•ML Do nol frt * •»•*. on I
" " " " •! I" "
ft* Mil. Do not
War**nO*Ml trt k oyo.
IMopi
IMo»
(II) fnvfronmenfal nasdrdi Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
Injury or damage. Examples of the
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide Intended for out-
door use contains an active Ingredient
with a mammalian acute oral LDM of
100 or lew. the statement "This Pentl-
clde I* Toxic to Wildlife" Is required.
(B) If a pesticide Intended for out-
door line contains an active Ingredient
with a fish acute IX\> of 1 ppm or IRSS.
the statement "This Pesticide In Toxic
to Fl.ih" Is required.
(C) If a pestfclde Intendrd for out-
door use contains an active Ingredient
with an avlan acute oral LD» of 100
mg/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide Is Toxic to Wildlife" Is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result In fatality to
birds, fish or mammals, the statement
"This pesticide b extremely toxic to
wildlife (fish)" to required.
(B) For uses Involving foliar appllca-
lion to agricultural crops, forest*, or
shade trees, .or for mosquito abate-
ment treatments, pesticides Ionic In
pollinating Insects must bear Appropri-
ate label cautions.
(PI For all outdoor lines other than
aquatic applications the label muni
bear the caution "Keep out of lakes.
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(Ill) rtij/tlcal or chemical harardt.
Warning statement* on the f lammsbll-
Ity or explosive characteristic.1* of Hie
pesticide are required as follows:
rMipohf __ _ r
or Mov W F; • SWM to o
FMi poM olmo W Fw«iiolOMjieTF«IS»
•m oitanlon bj ma* tun II ki lorg tt • O^tnjt
tertn,
FfcmnMfcl* ConMnk w«>o?
•IMrti. *n4 opm •••• Oo "Of I
EIIKMWO to IgnniOMM Ibono ISO" r mr <•"• I
Cimliaili wnd* pioMWO Do nol OM or doto'iiMi tool 01 ****>
Oo ml punekif 01 »«*iint» ouMoVim F^mn lo
llv* F
(B) MowwHUBUto Com *Mtm»
Wow Mr F and not ow W F.
Atooo «T F and not OMt IMT F
wW Iwjljl wVV
(I) DirecHon$ for l/*«-(l) General
nraulremenfj—(I) Adequacy and clar-
ity o/ direction*. 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 pf 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.
(Ill Placf.tnf.nl o/ directions /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 matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, mich
printed or graphic matter Is seeurely
attached to each package of the pesti-
cide, or placed within the oiiUldr
wrapper or bag:
(B) The label bears a reference to
the directions for use In accompanying
leaflets or circulars, such as "Re.e di-
rections In the enclosed circular:" and
(C) The Administrator determines
that It la not necessary for such direc-
tions to appear on the label.
(Ill) Vxceptlonf to requirement far
direction for tue-(A) Detailed direc-
tions tor use may be omitted from la-
beling of pesticides which are Intended
for use only by manufacturers of prod-
ucts other than pesticide product* In
their regular manufacturing processes.
provided that:
-------
} 1*2.10
<1) The label clearly •horn thai UM
product to Intended lor UM only hi
manufacturing processes and specifies
the typed) of product* Involved.
(2) Adequate Information such a>
technical data sheet* or bulletins, to
available to the trade specifying the
type of product Involved and IU
proper use In manufacturing; process-
es:
(2) The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
ucts: and
(4) The Administrator determine!
that such directions are not- necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Deuiled directions lor use may
be omitted from the labeling of pesti-
cide product* for which sale Is limited
to physicians, veterinarians, or drug-
gists, provided that:
(!) The label clearly states that the
product to for use only by physician*
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreamnable adverse ef-
fects on man or the environment; and
The product as finally manufac-
tured, formulated, mixed, or repack-
aged to registered; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable advene ef-
fecta on man or the environment.
IHto 40—*r*4octl*» •!
(3) Coifmf* o/ INrecftoiu for Ute.
The directions for use shall Include
the following, under the headings) •'Di-
rections for Use-:
(I) The statement of urn classifica-
tion as prescribed In H3.1OiJ> Immedi-
ately under the heading ••Directions
for Use.**
Immediately below the state-
ment of use classification, the state-
ment "Jt to a violation of Federal law
to use this product In a manner Incon-
sistent with Its labeling."
(Ill) The slte<8> of application, as for
example the crops, animate, areas, or
objects to be treated.
.IOh. t. I»1S|
III Criteria for drUrwInalUim of <
reasonable adverse effrrb.
forfa far Itittanct oy Nnttr ,
fnfenX to Deny RegUtraUon, tmnc
RroMretton. or to Hold a llfjfrlito
(I) PreAmpdon. (I) A rebutta/hta pi
sumptlorXshall arise, that a /ollre .
Intent to deny registration nnrsnant I
section 3(c\6) of Uie Act. A notice .
Intent to caWel registration pumuai
lo section 64bMI) of tMe Act. or
notice of Intent to hohf a hearing i
determine whether V"° reglslratio
should be cancelled
proprlate. shall __
termination by the,
the pesticide m
the criteria for ifsk
graph (aM3) of yhto
determlnai
shall Issue
the appl
may be. _
registrant
submit
presu
denied, as a|
_ led. upon a d<
tdmlnlstralor lli>.
exceeds any «
forth In PHI i
.Ion. Upon sue
the \Admlnlsl raU
by ceNlflcd mall I
or registrant, an the ra,-.
_ that the Wllcanl i.
r has the oppoUiiiilly I
'Idence In rebuttal of Mir
In accordance with lin"
graph ikKI) of this section. Th\ ar»pl
cant or registrant shall have for\y flv
(IB) ifays frohi the date such no_
sentr to submit evidence In rebull
th/ presumption; provided,
tlist for good cause shown the Adm.,
itrator may grant an additional six I
-------
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.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks/ and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
102
-------
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.
103
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can/ jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol )
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused 1, 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.
104
-------
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 finsate is a violation
of Federal Law. if these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesti.cide 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 Environ-
mental 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."
105
-------
PEST/DLS-2
P003
P070
P004
POOS
P006
P008
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-Q4-4
297-97-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with RCRA # 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
Me thorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide
(OMPA, schradan)
Parathion
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
?072
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
106
-------
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 (>10%) 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-ethy1 0-(2,4,5-trichlorophenyl)
ethylphosphonothioate F027
2,2'-Methylenebis F027
(3>4 /6-trichlorophenol)
(Hexachlorophene)
—Potassium salt of 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-Ci8)-l/3-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
35109r57-0
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
107
-------
PEST/DIS-4
—Isopropanolamine salt
—Monohydroxylalurainum 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
2,4,6-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
108
-------
PEST/DIS-5
— Isopropyl ester F027 93-78-7
—Propylene glycol isobutyl F027 53466-86-7
ether ester
—Tripropylene glycol isobutyl F027 53535-32-3
ether ester
4-(2,4,5-Trichlorophenoxy)butyric F027 93-80-1
acid [2,4,5-TB]
2-(2,4,5-Trichlorophenoxy)ethyl F027 69633-04-1
hydrogen sulfate [2,4,5-TES]
1,4' ,51-Trichloro-2'-(2,4,5- F027 69462-14-2
trichlorophenoxy)
methanesulfonanilide [Edolan U]
109
-------
PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST
[40 CFR 261.33(E)]
(with RCRA t, and CAS t
Acetone
Acrylonitrile*
Amitrole
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*
Dichlorodifluoromethane
(Freon 12®)
3 ,5-Dichloro-N-(1,1-dimethyl-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)
U002
U009
0011
U019
U028
U136
0211
U034
U036
U037
0039
U044
0048
0051
0052
0056
0057
0142
0066
0069
0062
0070
0072
0075
0192
0060
0061
0025
0240
0083
0084
0102
0041
0112
0038
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
110
-------
PEST/DIS-7
Ethylene dibromide (COB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane*
Hydrofluoric acid
Isobutyl alcohol*
Lead acetate
Lindane*
Maleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol (methanol)
Methyl bromide
Methyl chloride
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(hexachlorophene)
[acute waste per 261.31]
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*
Resorcinol
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]
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
U080
U159
U161
U165
U169
U170
U184
U185
U242
U188-
U196
U201
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
111
-------
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
112
-------
III. USE INDEX APPENDIX
113
-------
EPA Compendium of Acceptable Uses
HEPTACHLOR
TABLE OF CONTENTS
Site Name Page
TERRESTRIAL NON-FOOD CROP 2
(Noncrop, tilde Area, and General Indoor/Outdoor Treatments) 2
Buried Cable Closures 2
DOMESTIC OUTDOOR 3
(Wood or Wood Structure Protection Treatments) 3
Terrestrial Structures 3
INDOOR • 9
(Wood or Wood Structure Protection Treatments) 9
Terrestrial Structures 9
Issued: 8-29-84 III-044801-1
Provisional Update: 12-04-86
ll L
-------
EPA Compendium of Acceptable Uses
HEPTACHLOR*
(AND RELATED COMPOUNDS)**
TYPE PESTICIDE! Insecticide
FORMULATIONS;
Tech (72%)
FI (3.7%, 25.6%, 26.9%)
G (5%)
EC (0.25 Ib/gal, 1 Ib/gal, 1.5 Ib/gal, 2 Ib/gal, 2.01 Ib/gal, 2.1 lb/
gal, 2.2 Ib/gal, 2.5 Ib/gal, 3 Ib/gal, 8.51%)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE PESTICIDE. Heptachlor
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:
Alfalfa 0.0 ppm
Apples 0.0 ppm
Barley 0.0 ppm
Beans, Lima 0.0 ppm
Beans, Snap 0.1 ppm
Beets 0.0 ppm
Beets, Sugar 0.0 ppm
Brussels Sprouts 0.0 ppm
Cabbage 0.1 ppm
Carrots 0.0 ppm
Cauliflower 0.0 ppm
Cherries 0.0 ppm
Clover 0.0 ppm
Clover, Sweet 0.0 ppm
Corn 0.0 ppm
Cotton, Seed ' 0.0 ppm
Cowpeas 0.0 ppm
Grapes 0.0 ppm
Grasses, Pasture 0.0 ppm
Grasses, Range 0.0 ppm
Kohlrabi 0.0 ppm
Lettuce 0.1 ppm
Meat 0.0 ppm
*heptachlorotetrahydro-4,7-methanolndene
**Percentages of related compounds not reflected in this entry.
Issued: 8-29-84 III-044801-1
Provisional Update: 12-04-86
115
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EPA Compendium of Acceptable Uses
HEPTACHLOR
GENERAL WARNINGS ASP LIMITATIONS (continued)
Milk 0.0 ppm
Oats 0.0 ppm
Onions 0.0 ppm
Peaches 0.0 ppm
Peanuts 0.0 ppm
Peas 0.0 ppm
Peas, Black-eyed 0.0 ppm
Pineapples 0.0 ppm
Potatoes 0.0 ppm
Radishes 0.0 ppm
Rutabagas • 0.1 ppm •
Rye 0.0 ppm
Sorghum, Grain (Milo) 0.0 ppm
Sugarcane 0.0 ppm
Sweet Potatoes 0.0 ppm
Tomatoes 0.0 ppm
Turnips (with tops) 0.0 ppm
Wheat O.-O ppm
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
TERRESTRIAL NON-FOOD CROP
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
680000A Buried Cable Closures
SASAYA Fire ant 0.2 oz/buried Application in burled pod mounted
cable clo- electric power transformers and ca-
sure size 1 ble television and telephone pedes-
sq.ft tals. Open plastic bag and pour en-
(57. G) tire concents directly into buried
cable closure. One bag will treat
burled closures size 1 square foot.
Issued: 8-29-84 III-04A801-2
116
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Site and Pest
DOMESTIC OUTDOOR
EPA Compendium of Acceptable Uses
HEPTACHLOR
Dosages and Tolerance, Use, Limitations
Formulatioa(s)
64000KA
MGDAGA
(Wood or Wood Structure Protection Treatments)
Terrestrial Structures
Subterranean ter-
mites (Including
Coptotermes,
Heterotermes,
Reticulitermes,
and Zootennopsis
spp.)
0.5-1% emul-
sion
(1.5, 2,
2.01, 2.2,
2.5, 3 lb/
gal EC)
—OR MAI—
0.06Z emul-
sion
(0.25 Ib/gal
EC)
or
0.2-0.5%
emulsion
(1, 2, 2.1
Ib/gal EC)
(8.51% EC)
Soil contact wood protection 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. Heptachlor
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 co
control termites living in the
structure.
It is necessary for the effective
use of heptachlor that the service
technician be familiar with current
control practices including trench-
ing, rodding, 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, Reticulitermes 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-044801-3
117
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EPA Compendium of Acceptable Uses
HEPTACHLOR
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Terrestrial Structures (continued)
should be eliminated by providing a
chemical barrier and/or repairing
faulty construction.
Contamination of public and private
water supplies must be avoided by
following these precautions: Use
antiback-flow equipment or proce-
dures to prevent syphonage of pes-
ticide back into water supplies.
Do not treat soil that is water
saturated or frozen. Consult state
and local specifications for recom-
mended distances of treatment areas
from wells, and refer to Federal
Housing Administration (F.H.A.) Spe-
cifications for further guidance.
All nonessential wood and cellulose
containing materials, including
scrap wood and form boards, should
be removed from around foundation
walls, crawl spaces, and porches.
PRECOKSTRUCTION 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-044801-4
118
-------
Site and Pest
EPA Compendium of Acceptable Uses
HEPTACHLOR
Dosages and Tolerance, Use, Limitations
Formulation(s)
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
to 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-044801-5
119
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EPA Compendium of Acceptable Uses
HEPTACHLOR
Site and Pest Dosages and Tolerance, Use, Limitations
Fonnulation(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
Postconstruction 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-044801-6
. 120
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Site and Pest
EPA Compendium of Acceptable Uses
HEPTACHLOR
Dosages and Tolerance, Use, Limitations
Formulation(s)
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-044801-7
121
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Site and Pest
EPA Compendium of Acceptable Uses
HEPTACHLOR
Dosages and Tolerance, Use, Limitations
Formulatlon(s)
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.
4. 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.
RETREATHENT RESTRICTIONS
Retreatment for subterranean ter-
mites should only be made when there
is evidence of relnfestations subse-
quent to the initial treatment, or
Issued: 8-29-84
III-044801-8
-------
EPA Compendium of Acceptable Uses
HEPTACHLOR
Site and Pest Dosages and Tolerance, Use, Limitations
Formulatloa(a)
Terrestrial Structures (continued)
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 chlordane,
technical.
INDOOR
(Wood or Wood Structure Protection Treatments)
'64000NA Terrestrial Structures
Refer to DOMESTIC OUTDOOR, (Wood or Wood Structure
Protection Treatments), Terrestrial Structures.
Issued: 8-29-84 III-044801-9
123
-------
IV. BIBLIOGRAPHY APPENDICES
124
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
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.
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 wichin 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 witn a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon.them, treating them as a
single study.
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.
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.
125
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(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 "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Heptachlor Standard
MRID CITATION
00050054 Goldenthal, E.I.; Wazeter, F.X.; Dean, W.P. (1974) Acute Toxicity
Studies in Rats and Rabbits: IRDC Report No. 163-294. (Unpublished
study received January 7, 1977 under 876-7; prepared by
International Research and Developmemnt Corp. Chicago, 111.;
CDL:227550-A)
00066843 Goldenthal, E.I.; Wazeter, F.X.; Dean, W.P. (1972) Primary Skin
Irritation and Corrosive Hazard Study in Albino Rabbits: IRDC
Report No. 163-173. (Unpublished study received Jan 7, 1977
under 876-7; prepared by international Research and Development
Corp., submitted by Velsicol Chemical Corp., Chicago, 111.;
CDL:227545-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 Chloroheptor.
#6 to Bluegill Sunfish, Leponis macrochirus Ratinesque, 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-I)
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)
00108085 Bentley, R. (1974) Acute Toxicity of Gold Crest Termide to Bluegill
(Lepomis 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)
GS0175-001 U.S. EPA (1972) Pesticidal Aspects of Heptachlor in Relation to
Man and the Environment. Unpublished report prepared by
Special Pesticide Review Group. 79 p.
GS0175-003 Mauer, I. (1986) The Mutagenicity Assessment (Gene-Tox Profile)
of Heptachlor/Heptachlor Epoxide: Addendum to the Registration
Standard. Memorandum to Henry Spencer dated November 25, 1986.
27 p.
127
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Heptachlor Standard
MRID CITATION
GS0173-003 Felkner, I. (1986) Overview: Heptachlor Metabolism in Mammals.
EPA Contract No. . Dynamac Corp., NO. .
Unpublished review .
GS0173-004 U.S. EPA (1985) Carcinogenicity Risk Assessment for Chlordane
and Heptachlor/Heptachlor Epoxide. Unpublished report
prepared by Carcinogen Assessment Group. 138 p.
GS0144-012 Johnson, W.; Finley, M. (1980) Handbook ot Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates. USDI Publication
137, Washington, D.C.
-2-
128
-------
V. FORMS APPENDICES
129
-------
OMB Approval No. 20000468 (Expire* 13-31-83)
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
£PA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With rapect to thi requirmtnt to wbmit "jmric" data imposed by tin FIFRA action 3(C)(2)(B) notics contained in tha nfuencvi
Guidance Document. I m rBpmdini in tfw MIOMng nunmn
Q1. I iwil siamit dm in • tnratfy RIMMT m smfy the followmg requirement!. If the ten proceduiei I will tut deviate from (or are nut
spacrfM hi) tht R^otntiniGaidriiPHorita Avncabcaanmid in du Repara of Expert Groups to tfwOwmwU Group. OECO
Clwrnical* Tetmg Proywuni, I aidai *• protocol* thit I will IUR
Attach separate page with a list of the data requirements your company
agrees to satisfy.
DZ. I hmmond into MayMOMrtwthaMwmoraottoragimiraundir FIFRA ncBon J(C>(2)(BHn) to aufy riM followina. data
raquiram«ra Tin an,
-------
OMB Approval No. 20000468 (ExpireK 12-31-831
(To qualify, etrtiffALL fourfttmti
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to repreMnt the) following firm(s) who am subject to the require-
ments of e Notioa under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAM OF PIMM
EPA COMPANY NUMBER
(This firm ar group of firmi i« referred to below at "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary .-However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has off trad in writing 10 enter into such an agreement. Capias of tha off ars are attached. Thai offer was irrevocable and included an offer to ba
oound ay an arbitration dmsion under FIFRA Section 3(c)(2)(8)(iii) if final agreement on all terms could not ba reached otherwise. This offer was made
to the following h'rm(s) on tha fallowing date(s):
NAME OP FIRM
DATE OF OFFER
However, ncne of those lirm(s) accepted my offer.
4 Mv firm requests (hat EPA not suspend the registration^) of my firm's product Is), if any of the firms named in paragraph (3) above
*ste i
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PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
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
Identicy of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary •
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octano I/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
132
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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
31-6
Name of Test
Stability
Oxiai zing/ reducing
reaction
Flammability
Exploaability
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 aermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
*
I am complyinc
data requireme
Citing MRID
Number or
EPA Accession
Number
1 with
snts by
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assignee
133
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FORHULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Name
Applicant's Name and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s):
(2) Each active ingredient listed in paragraph (1) is present solely
as the result of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
name, the source of the active ingredient(s) listed in paragraph (1).
OR
(B) The Confidential Statement of Formula dated on file with
the EPA is complete, current and accurate and contains the information
required on the current CSF 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
nate Title
EPA Form (April 1985)
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