UnitMSUrtM
Environment*! Protection
AgMicy
Office of
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Wohinyton DC 20480
December 1986
&EPA
Guidance for the
Reregistration of
Pesticide Products
Containing Aldrin
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
ALDRIN
AS THE ACTIVE INGREDIENT
Case No. 0172
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 10
A. Summary
B. Preliminary Health Risk Assessment
C. Environmental Profile
D. Additional Concerns
E. Tolerances and Action Levels
IV. Regulatory Position and Rationale 26
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 35
i
VI. Requirement for Submission of Generic Data 37
A. What are Generic Data?
B. Who Must Submit Generic Data?
C. What Generic Data Must be Submitted?
D. How to Comply with DCI Requirements
E. Procedures for Requesting a Change in Protocol
F. Procedures for Requesting Extensions of Time
G. Existing Stocks Provisions upon Suspension or
Cancellation
VII. Requirement for Submission of Product-Specific Data . . 42
VIII. Requirement for Submission of Revised Labeling 43
IX. Instructions for Submission 44
A. Manufacturing Use Products (sole active)
B. Manufacturing Use Products (multiple active)
C. End Use Products
D. Intrastate Products
E. Addresses
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APPENDICES
I. DATA APPENDICES 47
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES 68
Summary of label requirements and table
40 Cf'R 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX 95
IV. BIBLIOGRAPHY APPENDICES 106
Guide to Bibliography
Bibliography
V. FORMS APPENDICES 113
FIFRA §3(c)(2)(B) Summary Sheet (EPA Form 8b80-l)
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
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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 his product and labeling
into compliance with FIFRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of 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 reguirements 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: Aldrin
Chemical name: 1,2,3,4,10,10-hexachloro-l,4,4a,5,8,8a-
hexahydro-exo-1,4-endo-5,8-dimethanonaphthalene
Other names: Aldrine (France), HHDN (Great Britain), Aldrex®,
Aldrex 30®, Aldrite®, Aldrosol®, Altox (All
Indian Medical), Bangald® (Bangalore Pesticides),
Drinox®, Octalene® (Velsicol Chemical Corp.),
Rasayaldrin® (Krishi Rasayan), Seedrin® Liquid
(discontinued by Rhone-Poulenc, Inc.), Entoma
15949, and Compound 118
CAS Registry number: 309-00-2
EPA Pesticide Chemical Code (Shaughnessy) number: 045101
Physical characteristics: Empirical Formula:
Molecular weight: 364.93
Color: tan to dark brown (technical)
Physical state: crystalline solid
Odor: mild chemical odor
Melting point: 104 to 105.5 °C
Boiling point: decomposes at 1 atm.
Solubility: very soluble in most
organic solvents; practically
insoluble in water
Density: 100 Ib/cu ft
Vapor pressure: 6.6 x 10~6 mmHg at
25 °C
Stability: stable with alkali and
alkaline-oxidizing agents. Reacts
with concentrated mineral acids,
acid catalysts, acid-oxidizing
agents, phenols, and active metals.
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B. REGULATORY HISTORY
Aldrin was first synthesized as a pesticide in 1948; its major
metabolite and epoxidation product, dieldrin, is also a pesticide
in its own right. Aldrin and dieldrin received registration
approval for use in the U.S. in 1949, under the early FIFRA.
In general, the regulatory histories of aldrin and dieldrin
have been closely parallel. Until 1974, both aldrin and dieldrin
were extensively used as broad-spectrum insecticides on corn
and a wide range of other agricultural crops. Both chemicals
also had a number of non-agricultural uses including termite
control.
In 1974, the EPA Administrator suspended nearly all uses of
aldrin and dieldrin for reasons that primarily included the
cancer risks posed by both compounds, based on laboratory evidence
considered together with exposure information available to EPA
at that time (39 FR 37246). Other grounds for the 1974 aldrin/
dieldrin suspension order included the persistence of dieldrin
residues in the environment, and the bioaccumulation of dieldrin
through the food chain. Based on monitoring data collected by
EPA, it was estimated that in 1970, 99.5 percent of the human
population in the U.S. had dieldrin residues in their tissues.
Although aldrin is not very persistent in the form of the parent
compound, it readily converts to dieldrin in the environment and
in biological systems including the human body. In addition to
the human health risks associated with aldrin and dieldrin,
evidence showed that endangered species such as the bald eagle
were at risk from exposure to dieldrin.
All uses subject to the suspension order, including all food uses,
were ultimately cancelled. Tolerances for aldrin and dieldrin
were not revoked at the time of their cancellation in 1975 for
food and feed uses because of the persistence of aldrin/dieldrin
in the environment and the resultant expectation that residues
would be present in raw agricultural commodities for a significant
time period. However, EPA is now proceeding with the revocation
of these tolerances, to be replaced by action levels for unavoidable
residues resulting from environmental contamination, in accordance
with a September 1982 agreement among the Food and Drug Adminis-
tration (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 March 13, 1985 (50 FR 10080), EPA published a proposed rule
under the Federal Food, Drug, and Cosmetic Act (FFDCA) to revoke
all tolerances for residues of aldrin and dieldrin in or on food
and feed commodities. The final rule effecting the revocation
of these tolerances is scheduled for publication in the Federal
Register in early 1987. There are also several existing action
levels for aldrin/dieldrin that were previously adopted by the
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Food and Drug Administration (FDA) to cover unavoidable residues
in food and feed commodities where no tolerances had been estab-
lished. In conjunction with the revocation of tolerances for
aldrin and dieldrin, EPA is recommending that most of these
action levels be retained without modification (see section
III.D of this Registration Standard).
Three uses of aldrin and dieldrin were specifically exempted
from EPA's suspension and cancellation actions because they were
believed to result in insignificant exposure and, consequently,
insignificant risk. Thus, the registrations of aldrin and
dieldrin were retained for subterranean termite control and for
two minor uses (the dipping of roots and tops of non-food plants,
and moth-proofing in manufacturing processes using totally
enclosed systems) that were subsequently cancelled voluntarily
at the request of the registrant.
More recently, the termiticide use of aldrin, dieldrin, and other
pesticides registered for termite control was subject to a pre-
liminary 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 (aldrin,
dieldrin, heptachlor, lindane, pentachlorophenol, and chlorpyrifos),
as well as chlordane. In summary, the Agency found that the
benefits of the termiticides, particularly the chlorinated
cyclodienes (chlordane, heptachlor, aldrin, and dieldrin), were
generally very high, but definitive health and exposure data
were lacking to support risk assessments for regulatory purposes.
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 exposures
to occupants. For aldrin 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.
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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
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 aldrin is as follows.1
The 90-day pilot phase of the aldrin indoor air monitoring study
has been completed, and these preliminary results have been
reviewed by EPA and are discussed in this Registration Standard.
The metabolism data required from the registrant have also been
submitted and reviewed. However, the mutagenicity data require-
ments have not been fully satisfied, and additional mutagenicity
studies are being required under this Standard. The registrant
requested a waiver of the requirement for a subchronic inhalation
study in rats on the grounds that existing data from oral feeding
studies could be used for the purpose of assessing the toxic
response (other than carcinogenicity) from respiratory exposure
to aldrin. A waiver was granted for this particular data require-
ment (see section III.B.2 of this Standard).
Finally, it should be noted that EPA's Office of Water Regulations
and Standards has recommended water quality criteria, under
section 304 of the Clean Water Act, for ambient water concentra-
tions of aldrin and dieldrin. EPA issues such criteria under
section 304(a) of the Clean Water Act, which requires the
Agency to publish criteria 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 modifi-
tion, by individual States and may thus become enforceable State
1 The registrants of dieldrin declined to sponsor the requisite
data. As a result, registrations of all termiticide products
containing dieldrin were suspended in 1984.
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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 aldrin and
their supporting scientific assessments are described in an
October 5.980 document, "Ambient Water Quality Criteria for
Aldrin/Dieldrin (EPA 440/5-80-019)," 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 aldrin and dieldrin, and (2) for protection of human health
from potential carcinogenic effects due to exposure to aldrin
and dieldrin through ingestion of contaminated water or contamin-
ated aquatic organisms.
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C. USE PROFILE
The sole registered use of aldrin in the U.S. is for control
of subterranean termites. Aldrin was previously manufactured
and sold in this country by Shell Chemical Company. Following
EPA's 1974 suspension and subsequent cancellation of most uses
of aldrin. Shell discontinued domestic production, and technical
aldrin has been imported from abroad, from Shell International,
for formulation and use in the U.S. Imports of aldrin ceased
temporarily in 1979 and 1980, then resumed in 1981 through 1985.
Between 1981 and 1985, an estimated 1.0 to 1.5 million pounds of
aldrin active ingredient were used annually, representing roughly
20 to 25% of the total termiticide market during those years.
According to information provided to EPA, aldrin has not been
imported since 1985, and current usage depends on the volume
of available stocks.
Aldrin is used for subterranean termite control either as a pre-
construction 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. In pre-construction treatments,
aldrin may be applied using a low-pressure spray, before slabs
are poured, creating a chemical barrier between potential or
existing termite colonies in the soil and wooden construction
materials. Post-construction treatment methods include techniques
such as "trenching," "rodding," and the drilling of holes in slabs
and foundation walls for the purpose of injecting the termiticide.
There are ten federally registered end-use products containing
aldrin. All but one of these products, which are formulated
into two- or four-pound per gallon emulsifiable concentrates,
are currently labeled for use only by commercial pest control
operators. There is one federally registered formulation
intermediate product. There are no "special local need" regis-
trations under FIFRA section 24(c), and no intrastate products.
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III. AGENCY FINDINGS
A. SUMMARY
The Agency has reviewed all data currently supporting the
registration of aldrin. Based on the available data, EPA has
reached the following conclusions. Many of these conclusions
are preliminary where additional data are required under this
Registration Standard. The points summarized below are presented
in further detail, in the context of EPA's science findings and
additional data requirements, in Sections B through D below.
1. Aldrin appears to be acutely toxic through oral and dermal
exposure, based on a review of summary reports which do
not satisfy EPA data requirements. Additional data are
required to fully assess the acute oral, dermal, and
inhalation toxicity of aldrin. In addition, special
product-specific subacute inhalation testing is required
to evaluate the potentia] of aldrin, the formulation
solvent(s), or the aldrin/solvent combination to cause
irritation of mucous membranes.
2. The Agency has concluded that aldrin does not cause
acute delayed neurotoxic effects.
3. Aldrin exposure may pose a significant health risk of
chronic liver effects to occupants of structures treated
with aldrin. Based on preliminary (90-day) exposure
data from an ongoing indoor air monitoring study, the
risk from long-term exposure to ambient air levels of
aldrin in buildings treated in accordance with label
directions has been roughly estimated to exceed EPA's
revised Provisional Acceptable Daily Intake (PADI) for
aldrin by three- to seven-fold.
4. The termiticide use of aldrin also poses an oncogenic
risk of regulatory concern, based on preliminary risk
estimates using the pilot air monitoring exposure data
now available. Aldrin is clearly oncogenic in laboratory
mice; the available test data in rats are inconclusive and
inadequate for assessing the oncogenicity of aldrin in the
rat species. In mouse studies separately conducted by
independent investigators, aldrin has induced tumors in
three strains of mice, with dose-related increases in the
proportion of malignancies. EPA will be considering the
indoor air monitoring data in determining whether human
exposure from the termiticide use of aldrin may be posing
risks of cancer and chronic liver effects that may warrant
regulatory action.
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5. Laboratory data show that technical aldrin is very highly
toxic to warm- and cold-water fish species, and to
freshwater invertebrates. Aldrin is also characterized
as very highly toxic to birds.
5. The termiticide use of aldrin does not appear to result in
exposures that threaten any endangered species.
7. The pesticide chlordane, an alternative termiticide, has
been found at significant levels in urban lakes in Iowa;
preliminary evidence indicates that 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 aldrin could be contaminating surface water.
Chlordane and aldrin, both of which are chlorinated
cyclodiene pesticides, have similar physical and chemical
properties as well as similar application patterns.
Therefore, it is reasonable to expect that they may have
comparable behavior patterns in the environment.
For this reason, the Agency is requiring a special study
to determine whether aldrin's use as a termiticide mav
be contaminating surface water. This study is intended
to provide information on (1) whether the termiticide
use of aldrin is resulting in residues of aldrin and its
metabolite dieldrin 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 aldrin and dieldrin as a result of the termiticide
use of aldrin.
8. Data available to EPA show a recurrence of misuse and mis-
application of aldrin termiticide products. Improper
application practices may result in contamination of air
systems in treated structures and unnecessarily hiqh
long-term ambient air exposure to occupants of these
structures. Moreover, the improper use of aldrin has
the potential to result in environmental contamination.
The incidence of misapplication and misuse can be reduced
by restricting the use of aldrin products to Certified
Applicators or persons under their direct supervision,
as specifically defined in label provisions prescribed by
EPA in this Registration Standard.
As a result of this Registration Standard review, the Agency
has determined that certain additional or revised label
restrictions are necessary. These include:
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0 Restricted use classification
0 Pesticide disposal procedures
0 Fish and wildlife toxicity warnings
e 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 aldrin as a terraiticide. These data must be developed
in order to maintain registrations of existing products or
register any new products containing aldrin. A summary of
these data gaps is given in Table 1. Please note that this
is only a summary and complete details can be obtained by
referring to the tables in Appendix I.
EPA will continue to evaluate the termiticide use of aldrin in
terms of the regulatory concerns identified in this Registration
Standard as additional information becomes available. The
Agency will continue to evaluate the risk of chronic liver
effects in humans from exposure to aldrin and also its potential
oncogenicity and determine whether additional regulatory
action is warranted.
The Regulatory Position and Rationale section of this Registration
Standard discusses the Agency's position on each of the regulatory
issues concerning aldrin, and the Required Labeling section
contains the specific wording required for each of the labeling
provisions.
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TABLE 1. SUMMARY OF DATA GAPS
(Please refer to the tables in Appendix 1 for detailed
information regarding these requirements)
Toxicology
Acute oral toxicity -- rats
Acute dermal toxicity -- rabbits
Acute inhalation toxicity -- rats
Primary eye and dermal irritation studies
Special (product-specific) subacute inhalation toxicity testing --
guinea pigs
Oncogenicity -- rats
Mutagenicity studies
Teratogenicity -- rats and rabbits
Reproductive effects -- rats (2-generation)
Environmental Fate/Exposure*
Hydrolysis study
Aerobic and anaerobic soil metabolism studies
Aerobic aquatic metabolism study
Leaching and adsorption/desorption study
Soil dissipation: field study
Photodegradation in water
Special monitoring study of aldrin residues entering surface water
from sanitary sewers, sumps, and drainage tiles from home
foundations known to have been properly iraated with aldrin
Applicator exposure studies
[Pending results of required environmental fate data, monitoring of
residues of aldrin in aquatic sit^s sn«J chronic fish and wildlife
toxicity studies may be required]
Product Chemistry
All product chemistry studies
An indoor air exposure monitoring study is currently underway, as
required through a special data call-in issued by EPA in February
1984.
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B. PRELIMINARY HEALTH RISK ASSESSMENT
Numerous data gaps exist for aldrin and few definitive conclusions
can be made pending receipt of additional data. The following
assessment is based on the data available and is therefore
subject to change.
1. Acute Toxicity. Adequate data are not available to fully
assess the acute toxicity of aldrin and additional studies
are therefore required on acute oral, dermal, and inhalation
toxicity. The published literature suggests that aldrin is
relatively toxic when ingested. Reported signs of acute
intoxication are primarily related to the central nervous
system (CNS) and include hyperexcitability, convulsions,
depression, and death. Summary data reports submitted to EPA
indicate an acute oral toxicity value for technical aldrin of
approximately 46 and 49 mg/kg/body weight in male and female
rats, respectively; and a minimum lethal dosage for dermal
toxicity ranging from 600 to 1250 mg/kg/body weight (0072077).
These values, if confirmed, would place aldrin in Toxicity
Category I on the basis of acute oral toxicity, and Toxicity
Category II on the basis of dermal toxicity. However, since
supporting data are not available to verify these summary
reports, they are considered supplementary information and,
thus, are inadequate to satisfy EPA's acute toxicity data
requirements.
There have been numerous incidents of acute intoxications
in humans from aldrin exposure among chemical plant
workers; however, recovery has been complete and relatively
rapid following removal from the exposure area. Based on
direct human evidence from these incidents, and the
dissimilarity of aldrin to known neurotoxic agents (i.e.,
organophosphates), the Agency has concluded that aldrin does
not cause acute delayed neurotoxic effects. For this reason,
a delayed neurotoxicity study is not required.
The Agency has also concluded that aldrin is not a skin
sensitizer, again based on human exposure data compiled
without reported dermal sensitization. The data supporting
this conclusion concern chemical plant workers who
experienced the kind of repeated skin contact which is
simulated in dermal sensitization studies under laboratory
conditions.
However, product-specific data are required so that EPA
may assess the potential of aldrin products to cause primary
eye and dermal irritation. The purpose of the requisite
primary dermal irritation testing is to determine the irritant
or corrosive effects of a single dermal exposure at a dose
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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 deter-
mining the appropriate toxicity category for aldrin.
In addition, special subacute, product-specific inhalation
testing with guinea pigs is being required under this Standard
to evaluate the potential of aldrin, the formulation solvent(s),
or the aldrin/solvent combination to cause irritation of mucous
membranes. This requirement arises from complaints received
from persons reporting upper respiratory problems following
the treatment of their residence for termite control.
2. Subchronic Toxicity. As noted previously in Section II.B, a
subchronic(90-day) inhalation study in rats was among the
studies originally required by EPA through the Special Data
Call-in issued for aldrin in February 1984. The registrant
requested a waiver of this requirement on the grounds that
(1) the oral intake of aldrin had been extensively studied,
and (2) the data from oral feeding studies indicate that when
orally administered, aldrin is almost totally absorbed by the
body; the results of long-term oral testing thus represent
a worst-case evaluation which could be used in lieu of
data from an inhalation study. EPA granted a waiver of this
particular requirement on this basis.
In available short-term (subchronic) feeding studies with
rats and mice, the major toxic effects exerted by aldrin were
reported to be mortality, depressed body weight, increased
liver-to-body weight ratios, and histopathological changes
in the liver known as chlorinated hydrocarbon insecticide
rodent liver (CHIRL) (GS0172-001). The subchronic studies
on file with the Agency are considered inadequate to satify
EPA's guideline requirements. However, the Agency is not
requiring a subchronic feeding study on aldrin, since existing
chronic feeding data are adequate for the purpose of defining
the liver as the target organ for toxic action, and are suffi-
cient to supercede the need for additional subchronic feeding
data.
Pending the results of the acute dermal toxicity study which
is required, the requirement for a 21-day dermal study is
reserved.
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3. Chronic Toxicity; Liver Effects. Administration of aldrin
in chronic and subchronic feeding studies in mice and rats
has resulted in cellular degeneration and histopathological
changes in the liver known as chlorinated hydrocarbon
insecticide rodent liver (CHIRL). CHIRL has occurred
at doses as low as 0.5 parts per million (ppm), or 0.025
milligrams per kilogram body weight per day (mg/kg/day), the
lowest dose tested in a two-year rat feeding study (GS0172-001)
Based on this lowest effect level (LEL) of 0.025 mg/kg/day,
EPA has calculated a provisional acceptable daily intake
(PADI) level for aldrin of 3 x 10~5 mg/kg/day, applying a
1,000-fold uncertainty factor. This calculated estimate is
provisional because the existing data base for aldrin is
lacking the following toxicology data: rat reproduction
study, rat teratology study, and rabbit teratology study.
The PADI for aldrin of 3 x 10~5 represents a revision of a
previously calculated PADI of 2.5 x 10"4 mg/kg/day, based
on 0.025 mg/kg/ day as a No Observed Effect Level (NOEL)
and a 100-fold uncertainty factor. On reevaluating the
2-year aldrin feeding study in rats, the Agency now considers
0.025 mg/kg/day, the lowest dose tested, to be an LEL rather
than an NOEL because of the occurrence of CHIRL.
A preliminary risk assessment for non-oncogenic liver effects
has been conducted based on the current PADI for aldrin and
human exposure data from an interim report on the first 90 days
of a year-long indoor air monitoring study required from
the registrant of aldrin through a special data call-in issued
by EPA in February 1984. As previously noted, the final
results from the completed monitoring study are scheduled for
submission to EPA in June 1987.
The pilot phase of this study, carried out in Indianapolis,
Indiana, involved treatment of 12 houses, each of crawl-space
and basement construction, with Aldrin 4 EC termiticide.
Prior to this study, it was believed that aldrin air levels
would peak shortly after treatment, and then decline. However,
the 90-day pilot results of this study indicate that average
air concentrations of aldrin in living rooms and kitchens in
both types of structures actually increased slightly between
days 28 and 90. The highest aldrin ambient air levels were
found in the basement.
Using the results of this report, EPA has evaluated three
exposure scenarios, which vary in terms of the level of
human activity and amounts of time spent in various parts
of the home. As described below, Scenario 1 is considered
to represent a reasonably average situation for a working
adult, in which the resident is assumed to spend 9 hours
outside the home each day, including weekends. By comparison,
Scenarios 2 and 3 represent "worst-case" exposure profiles
in that the resident is assumed to spend 24 hours per day
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in the basement or on the first floor of a basement-construction
home. Each of these scenarios is necessarily hypothetical,
since the life patterns of individuals vary widely, and EPA
does not have data on activity patterns and amounts of: time
spent at home by private individuals.
Specifically, the following assumptions were adopted for
each scenario:
0 Scenario 1;
— The resident spends 15 hours per day in the home,
10 at rest and 5 performing light work, and approxi-
mately 80% of this time is spent in areas that can
be represented by the mean of the concentrations
found in the kitchen and the living room. The
remaining time (20%) is spent in the basement.
— An average individual has respiratory volumes of
0.44 m^/hour while at rest, and 1.7 m^/hour while
doing light work.
0 Scenario 2;
— The resident (an invalid, for example) spends 24 hours
per day in the home, virtually all of this time at
rest, with a respiratory Volume 0.44 m3/hour.
— All of this time is spent on the first floor of a
basement-construction home.
0 Scenario 3;
— As in scenario 2, the resident spends 24 hours per
day in the home, virtually all of this time at rest,
with a respiratory volume of 0.44 mVhour.
— All of this time is spent on the basement level.
In addition, certain basic assumptions were made in each
instance:
0 Aldrin concentrations remain constant at the mean
levels achieved 90 days after treatment. Since aldrin
air levels actually increased slightly between days
28 and 90 in the pilot monitoring study, there is no
justification at this time for assuming that air
concentration levels decline after day 90.
0 An average individual weighs 60 kg
0 Aldrin is totally absorbed in the lung.
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Based on mean aldrin ambient air levels at 90 days after
treatment, extrapolated to lifetime exposure, the Agency
has calculated estimated annual human exposures of 55,
35, and 73 micrograms (ug)/kg/year (daily exposures of
1.51 x 10-4, 9.6 x lO-5, and 2.05 x IfT4 mg/kg/day) for
Scenarios 1, 2, and 3, respectively. When these estimated
exposures are compared to the PADI for aldrin of 3 x 10~5,
the resulting risk estimates for chronic liver effects
equate to 500%, 320%, and 680% of the PADI for Scenarios
1, 2, and 3, respectively. Because these preliminarily
estimated risks substantially exceed the PADI for aldrin,
the Agency is concerned that indoor air exposure to aldrin
may pose a significant health risk.
Chronic Toxicity; Oncogenicity. During the aldrin/dieldrin
suspension and cancellation proceedings, which resulted in
the suspension and cancellation of most uses of aldrin and
dieldrin, the existing data concerning the oncogenicity of
both compounds were subject to intensive evaluation, and
the following conclusions were drawn, as stated in the
formal opinion issued by the EPA Administrator on the
suspension decision:
"The evidence is conclusive that Aldrin-Dieldrin is
carcinogenic in mice. It has produced statistically
significant compound-related benign and malignant tumors
in the livers of five different strains of mice. It also
significantly increases the incidence of lung tumors.
This evidence of carcinogenicity is supported by additional,
though not definitive, evidence that Aldrin-Dieldrin has
increased the incidence of tumors in rats."
An updated assessment of the carcinogenic risks of aldrin
and dieldrin has been conducted by EPA's Carcinogen Assess-
ment Group (CAG) in accordance with the Agency's 1984
Proposed Guidelines for Carcinogen Risk Assessment (49 FR
42694; November 23, 1984). Based on this assessment (GS0172-
001), aldrin has been classified as a Group 82 (i.e, probable
human) carcinogen, with a cancer potency estimate (Q~**) of
16 mg/kg body weight/day.
These guidelines describe the general framework to be used
in developing an analysis of carcinogenic risk with regard
to assessing the weight of evidence of carcinogenicity from
human and animal studies. Based on the weight-of-evidence
analysis of available data, chemicals are categorized with
regard to their potential human carcinogenicity. Under EPA's
classification system, Group A, "Human Carcinogen," is
reserved for those chemicals for which there is sufficient
evidence of carcinogenicity from human epidemiological
18
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studies. Group B, "probable Human Carcinogen," is divided
into subgroups 1 and 2. Group BI requires some human epi-
demiological evidence. Since existing epidemiological studies
of aldrin provide inadequate evidence for carcinogenicity due
to methodological and data limitations, EPA does not have
reason to classify aldrin as Group A or BI.
Under the carcinogen risk assessment guidelines, chemicals
are categorized as Group 62 carcinogens if there is "sufficient
evidence" of the chemical's carcinogenicity from animal
studies. By comparison, Group C ("Possible Human Carcinogens")
chemicals are so classified if there is "limited evidence"
from animal studies. There is also a Group D ("Not Classified")
and a Group E that is reserved for chemicals shown to be
noncarcinogenic in animal and/or human studies.
In classifying aldrin as a Group 82 carcinogen, the Agency
considered all currently available data in both mice and rats.
In mice, three long-term carcinogenesis bioassays of aldrin
independently conducted by investigators affiliated with the
National Cancer Institute (NCI 1978a) and the Food and Drug
Administration (Davis and Fitzhugh, 1962; and Davis, 1965),
are considered adequate for risk assessment by current scientific
standards. In these studies, aldrin was found to produce
significant tumor responses in three different strains of mice
(C3H, CFi, and B6C3Fi) in both males and females at both
medium and high doses, with a dose-related increase in the
proportion of tumors that were malignant. In rats, the available
data from seven existing carcinogenicity bioass-ays are considered
inadequate and inconclusive, and a well-designed study in rats
is needed to determine the carcinogenic potential of aldrin in
this species. However, the available evidence in mice is
considered sufficient laboratory evidence to warrant the
classification of aldrin as a Group 82, probable human carcinogen.
Further support for this classification comes from the available
evidence on the carcinogenicity of dieldrin, the metabolite
and epoxidation product of aldrin, and the induction of tumors
by other chemicals such as chlordane, chlorendic acid, and
heptachlor, which are structurally related to aldrin.2
Dieldrin has also been classified as a Group B, (probable human)
carcinogen, with a cancer potency estimate (Q~**) of 20 mg/kg/
day. Dieldrin has produced liver carcinomas in multiple strains
of mice, with metastasis to the lungs in many instances. Chlor-
dane, heptachlor, and chlorendic acid have produced liver tumors
in mice, and chlorendic acid has also produced liver tumors in
rats.
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Using a cancer potency estimate (Q_i*) for aldrin of 16
mg/kg body weight/day, the Agency has estimated the incre-
mental cancer risks associated with indoor air exposure
estimates, based on preliminary data from the ongoing
aldrin air monitoring study, of 55, 35, and 73 ug/kg/year.
For these three exposure scenarios, the estimated increased
cancer risks are 2.4 x 10~3, 1.5 x 10~3, and 3.3 x 10~3,
respectively, raising concerns that the termiticide use of
aldrin may be posing significant cancer risks to occupants of
treated structures.
Mutagenicity Studies. A total of 21 mutagenicity studies,
some of which were submitted to the Agency in response the
the February, 1984 Data Call-in Notice, were reviewed under
this Standard. Of these, only two studies — one, an assay
for chromosomal effects and, the other, an unscheduled DNA
synthesis (UDS) assay in rat hepatocytes In vitro — were
found to be acceptable. Results of the assay for unscheduled
DNA synthesis in primary rat hepatocyte cultures (00109564)
.do not indicate a potential for aldrin to induce primary
damage in mammalian cells. However, additional data are
needed to confirm this finding, since presumptively positive
findings have been reported in other mammalian test systems.
Aldrin was negative in a dominant lethal assay of male ICR
Swiss mice (00123771). Collectively, the data on file
indicate that neither aldrin nor its metabolic degradate
dieldrin, possess mutagenic activities in bacteria (GS0172-004)
In addition, the data indicate that in eukaryotes, aldrin/
dieldrin may act as a promoter rather than an initiator of
cancer, though additional testing in mammalian cell systems
is necessary to affirm this apparent absence of potential
for direct genotoxic activity (GS0172-004). The Agency is
requesting the following studies to assess the mutagenic
potential of aldrin: mammalian cell gene mutation assays;
somatic cell cytogenetic assays; repair in mammalian cell
systems; adequately controlled promotion assays; mammalian
cell transformation in systems with an established data
base; assays for mitotic spindle effects; and assays which
can distinguish effects on replicative DNA synthesis from
UDS.
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6. Metabolism Studies. There are adequate metabolism studies
for aldrin. In a study where aldrin was administered to rats
by gavage for three months, aldrin was excreted primarily in
the feces (00151879). By twelve weeks after the last
dose, 99.5 % of all C14 administered had been excreted.
The fecal and urinary radioactivity consisted of relatively
minor amounts of unidentified polar metabolites. In another
study in which dogs were dosed orally with gelatin capsules
of aldrin at 0.6 mg/kg for 10 months with a 12-month recovery
period, no effects on plasma or serum alieterase activities
were seen and concentrations of aldrin in blood, fat, and
tissues were insignificant. Administration of aldrin resulted
in increased concentration of dieldrin in fat and liver and
after 10 months reached about 70 and 20 ppm, respectively.
When aldrin administration was discontinued, dieldrin levels
gradually decreased and dropped to 25 and 6 ppm, respectively,
by month 12 (00151872).
7. Teratology and Reproduction. The available reproductive
and teratology data are considered supplementary; therefore,
data gaps exist in both these areas of toxicity testing.
In a supplementary study using hamsters and mice, teratogenic •
effects were reported at doses purported to be one-half the
LD5Q values (GS0172-001). The teratogenic effects reported
were anomalies such as an open eye, cleft palate, and
webbed feet, and an increase in fetal deaths as compared to
controls. In a multi-generation reproduction study
using mice, reduced litter sizes occurred at birth at 10
ppm and above, and it was concluded that at 3 ppm a threshhold
NOEL was attained based upon equivocal effects of reduced
weanling weights (0090888). In a rat multi-generation study,
it was found that only doses above 2.5 ppm in the diet produced
significant pregnancy rate reductions, increased losses of
litters, and increased mortality in offspring as late as 5
days after delivery (00083074).
8. Applicator Exposure. Because data are not available to
characterize applicator exposure, EPA is unable to assess
the risks' posed to pesticide applicators as a result of
dermal and respiratory exposures to aldrin during the termi-
ticide application process. In order to evaluate the risks
of occupational exposure to aldrin, the Agency is requiring
the submission of appropriate dermal and respiratory data
from applicator exposure monitoring studies.
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C. ENVIRONMENTAL PROFILE
1. Ecological Effects. Additional ecological effects data
are not required at this time. Existing data are adequate
to show that aldrin is potentially very highly toxic to
both warm-water and cold-water fish species. The results
of acute warm-water fish studies show LC5Q values
ranging from 5 parts per billion (ppb) for largemouth
bass to 53 ppb for channel catfish (00003503). In cold
water fish, the values range from 2.6 ppb for rainbow
trout to 8.2 ppb for chinook salmon (00003503). Aldrin
is also very highly toxic to freshwater invertebrates on
an acute basis. The 48-hour EC50 3 values range from 18
ppb in a species of seed shrimp to 32 ppb in a species
of water flea (00003503).
Technical aldrin is also potentially very highly toxic to
birds. The acute oral LD5Q ranges from 6.59 rag/Kg in
the bobwhite quail to 520 mg/kg in mallard ducks (00111910).
Dietary studies indicate that technical aldrin is very
highly toxic to birds on a subacute dietary basis. The
subacute dietary LC5Q ranges from 34 ppm in the Japanese
quail to 155 ppm in the mallard duck (00022923).
Besides its inherent toxicity, aldrin is highly lipophilic
and may bioaccumulate in adipose tissue. This propensity
to bioaccumulate could cause aldrin 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 aldrin may
be contaminating surface waters should raise concerns
about potential aldrin exposure to fish or fresh-water
invertebrates, special monitoring of aquatic sites and
chronic fish and wildlife studies may be required.
2. Endangered Species. EPA does not have reason to believe that
the termiticide use of aldrin threatens any endangered species.
The Agency is aware of an incident where lethal concentrations
of dieldrin were found in the brains of dead gray bats (myotis
grisescens) collected in 1976-77 beneath a maternity roost in
a Missouri cave. However, the source of these residues was
reported to be the previously legal use of the parent compound
aldrin, which had been applied to cornfields for cutworm
control. Based on available information, the termiticide
use of aldrin according to label directions is not expected
to result in exposures that would jeopardize the gray bat
or other endangered species.
Environmental Concentration
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Environmental Fate. The Agency is unable to fully assess
the environmental fate of aldrin, because acceptable data
are lacking. However, available, supplementary data do
indicate general trends of aldrin behavior in the environ-
ment. Aldrin degrades readily to dieldrin, which is persistent
in the environment. In column-leaching studies, where aldrin
was applied to different soil types and then saturated with
water, residues of aldrin remained in the surface few inches
of the soil (00103661). Additionally, field studies indicate
that residues of aldrin remained in the top half-foot of soil
for 1.5 years following application (00103597). Although
these reports on leaching and field studies suggest that
aldrin/dieldrin would be unlikely to leach to underground
aquifers, additional data are necessary to assess the potential
for ground-water contamination as a result of the termiticide
use of aldrin.
To assess the environmental fate of aldrin in conjunction with
its domestic outdoor use pattern, the Agency is requiring the
following studies: hydrolysis; aerobic and anaerobic soil
metabolism; aerobic aquatic metabolism; leach or adsorption/
desorption; terrestrial field dissipation; and photodegrada-
tion 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 data are reserved pending
the results of the product chemistry requirement for an
octanol/water coefficient study. Finally, depending on
the results of the indoor air monitoring study now in progress,
further testing may be required in this area.
In addition, a special monitoring study is being required to
determine the extent of surface water contamination from the
termiticide use of aldrin. The purpose of this study is two-
fold: (1) to determine whether and to what extent termiticide
applications are resulting in residues of aldrin and its
metabolite dieldrin in drinking water and in fish for human
consumption, and (2) whether fresh-water fish and invertebrates
are at risk of being exposed to toxic levels of aldrin and
dieldrin as a result of its termiticide use.
This requirement arises from data compiled recently showing
significant levels of the termiticide chlordane in fish and
bottom sediment in two urban lakes in Iowa, 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
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(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) (GS0172-002). These preliminary
findings on chlordane raise the question whether the termiticide
use of aldrin could be contaminating surface water. Chlordane
and aldrin, 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 have comparable behavior patterns in the
environment.
D. ADDITIONAL CONSIDERATIONS: ALDRIN MISUSE AND MISAPPLICATION
For the purpose of assessing the human health and environ-
mental risks of aldrin, as discussed in this Registration
Standard, EPA has assumed the proper use of aldrin as a
termiticide in accordance with label directions. However,
reports to EPA have indicated a significant incidence of
misuse and misapplication of aldrin by professional applicators
employing soil injection and trenching methods.
The data indicate that applicators have inadvertently
contaminated structures while putting aldrin into prepared
injection holes or trenches. These types of incidents under-
score the need for applicators to be knowledgeable about
building construction elements or anomalies. When applying
aldrin by soil treatment methods, it is generally necessary
for applicators to take appropriate site-specific precautions.
Different types of house construction (i.e., rubble foundations,
crawl spaces, etc.) require different methods of treatment
as well as techniques to avoid contamination of ventilation
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 aldrin over and above levels
that may be anticipated on the basis of controlled ambient
air exposure monitoring. Additionally, the improper use of
aldrin has the potential to result in environmental contamina-
tion. For these reasons, considered together with the toxic
properties of aldrin and its potential to persist and bio-
accumulate in the environment in the epoxidized form of
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dieldrin, EPA is requiring that aldrin be restricted for
retail sale to and use by Certified Applicators or persons
under their direct supervision, as specifically defined in
label provisions prescribed by EPA in this Registration
Standard.
E. TOLERANCES AND ACTION LEVELS
Prior to the 1974 suspension and 1975 cancellation of all
food and feed uses of aldrin/dieldrin, tolerances for total
residues of aldrin and its epoxidation product, dieldrin,
resulting in or on raw agricultural commodities from application
of aldrin were established as listed in 40 CFR 180.135. As
noted in Section I.B of this Registration Standard, tolerances
were not revoked concurrently with these cancellations because
of the pesticides' slow rate of degradation and their 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 aldrin, 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 aldrin and dieldrin under the Federal Food, Drug,
and Cosmetic Act (FFDCA) was published March 13, 1985 (50 FR
10080) and public comment was invited. The final rule effect-
ing the revocation of aldrin/dieldrin tolerances is scheduled
for publication in the Federal Register in early 1987.
In addition to action levels to replace existing tolerances,
EPA is recommending that existing action levels be retained
without modification, with the exception of melons. The Agency
is recommending that the existing 0.15 ppm action level for
melons be lowered to 0.10 ppm. Other existing action levels
for aldrin/dieldrin range from 0.03 ppm (hay and other animal
feed, and eggs) to 0.3 ppm (milk and dairy products, fats
and oils, and fish and shellfish). However, 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 aldrin,
the Agency has made the following determinations. Refer to
Sections 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
aldrin may be v/arranted.
Rationale; Based on preliminary 90-day mean exposure data
from an ongoing, year-long indoor air monitoring study, the
risk of liver effects from exposure to ambient air levels of
aldrin in treated buldings has been roughly estimated to
exceed EPA's Provisional Acceptable Daily Intake (PADI)
level for aldrin by three- to seven-fold, depending on the
exposure scenario. EPA will also be considering the afore-
mentioned monitoring data together with the evidence on the
oncogenicity of aldrin to determine whether human exposure
to aldrin may be posing an oncogenic health risk of regulatory
concern.
2. In order to meet the statutory standard for continued
registration, the Agency has determined that the retail sale
and use of all end-use products containing aldrin 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 aldrin 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 determinatin
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 aldrin products;
b. Detailed information on construction elements of the struc-
tures likely to be encountered when applying aldrin 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
aldrin, potential impact on water supplies, and potential
impacts on the environment and treated structures;
f. Techniques for decontamination, if possible of structures
should an accident or misapplication occur;
g. Safety in storage and disposal of aldrin, aldrin product
containers, unused aldrin solution, and contaminated
protective equipment and clothing;
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h. Emergency procedures, should an accident occur, for the
protection of the applicator and the occupants of the
treated structure, and warning signs of misapplication
that would be useful to communicate to the occupants.
Training developed by industry or others in support of this
second option shall be submitted for review and approval to
appropriate State regulatory agencies in States which have a
termiticide technician 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 system of registration with the State
after the applicant has demonstrated to the State a satis-
factory level of competence in termiticide application.
Rationale: As stated in 40 CFR 162.ll(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." Data reported to
EPA indicate recurring misuse and misapplication of aldrin
termiticide products by pest control operators. In view
of the potential health hazards associated with exposure
to aldrin, the Agency is concerned about long-term and
acute exposures which may result from the improper use of
aldrin. 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 aldrin
over and above levels that may be anticipated on the basis
of controlled ambient air exposure monitoring. In addition,
the misuse of aldrin has the potential to result in environ-
mental contamination.
Several States have already restricted the use of aldrin.
EPA believes that the incidence of misapplication and
misuse of aldrin can be mitigated by restricting the use
of all aldrin products to Certified Applicators or persons
under their direct supervision, as defined above and in the
"Restricted-Use Pesticide" label provision prescribed in
Section IV.D. By presenting two options for compliance
with the restricted use requirement for aldrin, it is EPA's
intent to ensure that aldrin is competently applied:
either under the immediate, physical supervision of a
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responsible Certified Applicator who can direct the
implementation of site-specific precautions as appropriate
(Option 1); or, if a Certified Applicator is not physically
present, each State-registered technician working at the
site will have demonstrated competence to safely conduct
termiticide applications, following completion of a
training course in termiticide application administered
by the State in which he or she is working (Option 2).
The two options are intended to offer States some 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 aldrin. EPA believes that, where
a Certified Applicator is not physically present, formally
trained technicians are less likely to misuse or misapply
aldrin. The minimum training and registration criteria
set forth in this Registration Standard for State programs
are intended to ensure that all users of aldrin who are
not Certified Applicators have demonstrated competence in
all aspects of termiticide application ranging from compre-
hension 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
registration, the Agency has determined that aldrin product
labels must be revised to provide specific aldrin disposal
procedures.
Rationale; Aldrin products are acutely hazardous when
discarded, and improper disposal of excess pesticide,
spray mixture, or rinsate may result in environmental
contamination.
4. In order to meet the statutory standard for continued
registration, the Agency has determined that aldrin products
must bear fish and wildlife toxicity warnings.
Rationale; Data reviewed by EPA have shown that aldrin
is very highly toxic to warm- and cold-water fish species,
and to freshwater invertebrates; aldrin is also potentially
very highly toxic to birds. It is therefore imperative
that effluent containing aldrin not be improperly
discharged into surface waters or sewer systems.
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5. A special monitoring study is required to evaluate whether
and to what extent surface water contamination may be
resulting from aldrin's use as a termiticide.
Rationale: Alarm and its metabolite dieldrin are persistent
in the environment and can bioaccumulate in fish and fresh-water
invertebrates. Human dietary exposure to aldrin may occur
through consumption of contaminated drinking water and
fish. In addition, aldrin is potentially very highly toxic
to fish and freshwater invertebrates. The physical and
chemical properties of aldrin are similar to the properties
of chlordane, a cyclodiene termiticide which has been found
at significant levels in urban lakes in Iowa; 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 from
home foundations known to have been properly treated with
aldrin, are sampled for aldrin residues. Based on the results
of this study, additional regulatory action may be warranted.
6. Special product-specitic subacute inhalation testing is
required to evaluate the respiratory hazards to humans in
structures treated with termiticide products containing aldrin.
Rationale: The Agency has received reports trom individuals
complaining of upper respiratory problems associated with
termiticidal application of aldrin. To investigate the
extent of the problem, the Agency is requiring testing to
determine the potential of aldrin itself, the formulation
solvent(s), or the aldrin/solvent combination to cause
irritation of mucous membranes. Pending the results of this
testing, additional regulatory measures may be appropriate.
7. The Agency is requiring the submission of applicator
exposure data from dermal and respiratory routes of exposure.
Rationale; Additional data are needed to determine whether
exposure to applicators during termiticide application
may be posing significant health risks. Registrants are
referred to Subdivision u of the pesticide Assessment
Guidelines for acceptable exposure monitoring methodology.
The Guideline document is publicly available through the
National Technical Information Service (NTIS), Springfield,
Virginia 22161 (telephone: 703-487-465U) . Registrants must
submit appropriate protocols for these exposure studies
within 90 days.
30
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7(a). 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
aldrin 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 need clarification
to accomodate technical and safety aspects of termite
control and minimize exposure to homeowners and
applicators. Such revisions and precautions make the
treatment instructions more clear, minimize misapplication
and ensure compliance.
30 (a)
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8. In order to meet the statutory standard for continued
registration the Agency has determined that aldrin product
labels must contain a prohibition against application to plenum
houses (houses where the crawlspace beneath the building is
used to circulate heated or cooled air without ductwork).
Rationale; This restriction is necessary to guard against
potentially high levels of exposure. Information indicates that
application to these houses can result in very high indoor
air levels.
9. While data gaps are being filled, currently registered
manufacturing use products (MPs) and end-use products (EPs)
containing aldrin as the sole active ingredient may be
sold, distributed, formulated, and used, subject to the
terms and conditions specified in this Standard. Registrants
must provide or agree to develop additional data, as
specified in the Data Appendices, in order to maintain
existing registrations.
Rationale; Under FIFRA, the Agency does not normally cancel
or withhold registration simply because 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
changes are necessary.
10. The Agency has identified certain data requirements that
will receive priority review when received.
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:
§158.135 Toxicology
83-2 Rat Oncogenicity Study
83-3 Teratogenicity- Rat and Rabbit
83-4 Reproduction- Rat
84-2 Gene Mutation and Structural Chromosomal Aberration
84-4 Other Genotroxic Effects
Special Test- Guinea Pig Inhalation Study
31
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§158.130 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
164-1 Soil Dissipation Study
Water Monitoring Study
Applicator Exposure Study
Indoor Air Monitoring Study
31(a)
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B. CRITERIA FOR REGISTRATION
This Standard covers both manufacturing-use products (MPs)
and end-use products (EPs) containing aldrin^. Registrants
of aldrin 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 aldrin 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 aldrin
must be labeled for formulation into end-use products only
for termite control. The EPA Compendium of Acceptable Uses,
Appendix III, lists the approved application rates and methods
of application.
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).
End-use or manufacturing-use product containing aldrin may not
be released for shipment by a registrant or producer of that
product 12 months after the registrant's or producer's receipt
4 The Agency considers all currently registered end-use products
containing aldrin 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.
32
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of this Registration Standard, unless the product bears an
EPA-approved amended label which complies with this Registration
Standard.
End-use or manufacturing-use product containing aldrin may not be
distributed, sold, offered for sale, held for sale, shipped,
delivered for shipment, or received and (having been so received)
delivered or offered to be delivered by any person 24 months
after issuance of this Registration Standard, unless the product
bears an EPA-approved amended label which complies with this
Registration Standard.
1. All Products - All products must bear appropriate labeling
as specified in 40 CFR 162.10. Appendix II contains information
on labeling requirements. The following pesticide disposal
statement must appear on all labels:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a violation
of Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
2. Manufacturing-use Products - All manufacturing-use products
must bear the following statements:
"For formulation into end-use insecticide products intended
only for termiticide use."
"This pesticide is toxic to fish and wildlife. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public waters unless this product is
specifically identified and addressed in an NPDES permit. Do
not discharge effluent containing this product to sewer systems
without previously notifying the sewage treatment plant
authority. For guidance contact your State Water Board or
Regional Office of the EPA."
"The use of this product may be hazardous to your health.
This product contains aldrin, which has been determined to
cause cancer and adverse liver effects in laboratory
animals."
11 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."
33
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"Any article of clothing worn while applying pesticide
must be cleaned before re-use. Clothing should be
laundered separately from household articles. Clothing
that has been drenched or has otherwise absorbed
concentrated pesticide must be disposed of in a
sanitary landfill, incinerated, or burned if allowed
by State or local authorities."
3. End-use Products - Labels for all end-use products
must bear the following statements:
"RESTRICTED-USE PESTICIDE
The use of this product may be hazardous to your health.
This product contains aldrin, which has been determined
to cause cancer and adverse liver effects in laboratory
animals. This pesticide persists in the environment and
bioaccumulates in living organisms. Risks can be reduced
by closely following all use directions and precautions,
and by wearing the protective clothing specified elsewhere
on this label. Treated buildings may be contaminated,
resulting in hazards to the health of occupants if this
product is not properly applied and used only for the
purpose stated on the label.
For retail sale to and use only by Certified Applicators
or persons under their direct supervision and only for
those uses covered by the Certified Applicator's certifi-
cation. For the purposes of this product, direct 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 which meets EPA minimal requirements in
termiticide application and must be registered for termiticide
application in the State in which the uncertified applicator
is working."
"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 and
34
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long pants, or coveralls, and unlined, mid-forearm to
elbow length chemical-resistant gloves when mixing,
loading, or otherwise handling the concentrate."
" Any article of clothing worn while applying product
must be cleaned before re-use. Clothing should be
laundered separately from household articles. Clothing
that has been drenched or has otherwise absorbed
concentrated pesticide must be disposed of in a sani-
tary landfill, incinerated, or burned if allowed
by State or local authorities."
"Do not apply aldrin 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 aldrin to plenum houses (houses where the
crawlspace beneath the building is used to circulate heated
or cooled air without ductwork)."
4. Labels for all end-use products bearing directions for
subterranean termite control must be revised to include
the following (Note: each revision/change to the current
LIP use directions are high;ighted for easy reference):
34 (a)
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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 Eor 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, Heterotennes, and Coptotermes.
Choice of appropriate procedures should include consideration of
such variable factors as the design of the structure, existence
of air circulation in subfloor crawlspace, watertable, soil
type, soil compaction, grade conditions, and the location and
type of domestic water supplies and drainage systems. The biology
and behavior of the termite species involved are important factors
to be known, as well as suspected location of the colony and
severity of the infestation within the structure to be protected.
All nonessential wood and cellulose-containing materials, including
scrap wood and form boards, should be removed from around foundation
walls, crawlspaces, and porches. Effective termite control also
includes elimination of termite access to moisture by recommending
repair of faulty construction, grade, and/or plumbing.
For advice concerning current control practices with relation to
the specific local conditions, consult resources in structural
pest control and the State regulatory agency.
SUBTERRANEAN TERMITE CONTROL
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner
inconsistent with its labeling. This product may not be used
against any pests not named on the label. Apply only to establish
subsurface termite control barriers specified on product labeling.
Contamination of public and private water supplies must be avoided
by following these precautions: Use antibackflow equipment or
procedures to prevent siphonage of pesticide back into water
supplies. Do not treat soil beneath structures that contain
cisterns or wells. Do not treat soil that is water saturated or
frozen. Consult State and local specifications for recommended
distances of treatment areas from wells, if no state or local
government recommendations are available, refer to Federal Housing
Administration specifications for further guidance.
34(b)
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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 trill be covered by floors, entrance
platforms, or porches, and in other critical areas that will be
covered by construction. To produce a horizontal barrier, apply
the emulsion at the rate of 1 gallon per 10 square feet to fill
dirt. If fill is washed gravel or other coarse material, apply
at 1 1/2 gallons per 10 square feet.
- It is important that the emulsion reaches the soil.
- Applications shall be made with low pressure (less than
50 psi at the nozzle} using a coarse-spray nozzle when
establishing horizontal barriers.
- If concrete slabs cannot be poured over soil the same day
it has been treated, a waterproof cover such as polyethylene
sheeting should be placed over the soil to prevent erosion.
This is not necessary if foundation walls have been installed
around the treated soil.
VERTICAL BARRIERS
After the foundation walls have been poured or built, vertical
barriers may be established around the perimeters of floating or
supported slabs, around utilities penetrating the slab, and in
other critical areas. After the final exterior grading is
completed, vertical barriers say be created in back-filled soil
34(c)
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against foundation or a 11s. 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 o_n
interior slabs such as basement floors.
CRAWLSPACES
For crawlspacesf 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
34 (e)
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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, ventc, vatcr £nd sewer lines, and electrical conduits are
known and identified. Do not apply this product to soil beneath
slabs with subslab or intraslab ducting until ducts are permanently
plugged. Surface application is prohibited, (italics)
CONCRETE SLABS
Vertical barriers may be established by subslab injection inside
and rodding and/or trenching outside at the rate of 4 gallons of
emulsion per 10 linear feet. Injectors should not extend beyond
the tops of the footings.
Treat along the outside of the foundation and where necessary
just beneath the slab on the inside of foundation walls. Treatment
34(f)
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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 codding or by a grid
pattern injection using a rate of I 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 HALLS
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.
"here this treatment is necessary, access holes must be drilled
below the sill plate and should be through a lover mortar joint.
Before treatment through basement vails, seal the interior vail
and floor expansion joint vith mortar, caulk, waterproofing
material, or similar impervious sealant. Also, seal openings at
the top of the foundation vail. 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.
-------
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 craulspace:
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 soi'l as it
is replaced in the trench. Cover the treated soil with a
layer of untreated soil. Moisture barriers such as
polyethylene sheeting may be used in addition to the
untreated soil.
- If it is necessary to make an overall barrier under soil
in a craulspace, 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 ISO square feet of crawl space area.
EXCAVATION TECHNIQUE
If treatment must be made in difficult situations such as near veils
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.
34 (h)
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- After the treated soil has dried adquately, replace the
soil in the trench and cover with a layer of untreated
soil .
Pnor to using this technique near veils 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.
34 (i)
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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.
35
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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 exemption3, 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 tor 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.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.*
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 tor 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.
If you apply for a new registration for products containing
4 Registrations granted after issuance of this Standard
will be conditioned upon submission or citation of the data
listed in this Registration Standard.
37
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this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product it, 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.
38
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3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
39
-------
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either EPA's Pesticide Assessment Guidelines or the Reports
of Expert Groups to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the timeframe
for submission of the data, nor will extensions generally be
given to conduct studies due to submittal of inappropriate
protocols.
F. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end ot 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 ot 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,
40
-------
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 tor 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.
41
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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.
42
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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.
43
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IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing Aldrin
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.)
44
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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 Aldrin 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 Aldrin alone6/ or in combination
with other active ingredients
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4),
attached separately.
c. Formulator's Exemption Statement, if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
The Agency considers all currently registered end-use products
to be sole active ingredient formulations. The Agency does not
consider solvents or diluents to be insecticidal, and therefore,
must be declared as inerts.
45
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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 ot Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
46
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I. DATA APPENDICES
47
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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.
i
Table C contains product-specific data requirements that
apply only to an end use product.
, The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade ot 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
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
48
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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 satisty
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one .of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case/ when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its tiles, 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). It 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.
49
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TABLE A
GENERIC DATA RETIREMENTS FOR ALDR1N
Data Requirement
Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?!/ Citation V Data be for
Submitted? Submission?/
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and Dis- TGAI ti-l- Yes b Months
closure of Ingredients
61-2 - Description of Beginning TGAI H,I Yes 6 Months
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI H,I Yes b Months
Impurities
Analysis and Certification ot
Product Ingredients
62-1 - Preliminary Analysis TGAI H,I Yes 12 Months
62-2 - Certification of Limits TGAI H,I Yes 12 Months
62-3 - Analytical Methods to Verify TGAI H,I Yes 12 Months
Certified Limit
Physical and Chemical Characteristics
63-2 - Color TGAI H,I Yes 6 Months
63-3 - Physical State TGAI H,I Yes 6 Months
63-4 - Odor TGAI H,I Yes b Months
50
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TABLE A
GENERIC DATA REQUIREMENTS FOR ALDRIN
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?V Citation V Data be tor
Submitted? Submission2/
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
(continued)
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-1U - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
64-1 - Submittal of Samples
TGAI H,I
TGAI H,I
TGAI H,I
TGAI or PAI H,I
PAI H,I
PAI H,I
PAI H,I
TGAI H,I
TGAI H,I
TGAI, PAI H,I
Yes
NoV
Yes
Yes
Yes
Yes
Yes
NoV
Yes
Reserved^/
b Months
6 Months
b Months
6 Months
b Months
b Months
15 Months
(b Months - Progress
Report)
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been introduced and previously submitted
data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
3/ Not required since aldrin is a solid at room temperature.
4/ Not required since aldrin is practically insoluble in water.
5_/ If samples are needed, the Agency will request them.
51
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TABLE A
GENERIC DATA REQUIREMENTS FOR ALDRIN
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
tor
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:
TGAI or PAIRA H
TGAI or PAIRA H
TGAI or PAIRA N/A
TGAI or PAIRA N/A
TGAI or PAIRA H
TGAI or PAIRA H
TGAI or PAIRA
TGAI or PAIRA
163-1 - Leaching and TGAI or PAIRA
Adsorption/Desorpt ion
N/A
H
H
No
No
No
No
No
No
Yes
Yes3/
Yes
Yes3/
YesV
Yes
9 Months
Months
27 Months2/
(8 Months - Progress
Report)
27 Months^/
(8 Months - Progress
Report)
27 Months^/
(8 Months - Progress
Report)
12 Months
52
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TABLE A
GENERIC DATA REQUIREMENTS FOR ALDRIN
Data Requirement
Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? Citation Data be tor
Submitted? Submission1/
§158.130 Environmental Fate (continued)
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES-FIELD;
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(confined)
165-2 - Rotational Crops
(field)
165-3 - Irrigated Crops
165-4 - In Fish
TEP
TEP
TEP
TEP
PAIRA
TEP
N/A
N/A
H
TEP
TEP
H
N/A
N/A
N/A
N/A
N/A
TEP N/A
TGAI or PAIRA H
No
No
Yes
27 Months^/
(8 Months- Progress
Report)
Reserved^/
No
Reserved-^/
53
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TABLE A
GENERIC DATA REQUIREMENTS FOR ALDRIN
Data Requirement
Test
Substance
Use
Pattern
Does EPA Have
Data?
Bibliographic
Citation
Must Additional
Data be Submitted?
Timeframe
tor
Submission*/
§158.130 Environmental Fate (continued)
165-5 - In Aquatic Nontarget
Organisms
MONITORING STUDIES:
TEP
N/A
Water Monitoring Study
EXPOSURE STUDIES;
Applicators
Residents- Indoor Air
Monitoring Study
TEP
No
TEP
TEP
No
No
YesV 15 Months
(90 Days- Acceptable
Protocol)
(8 Months- Progress
Report)
YesV 6 Months
(90 Days- Acceptable
Protocol)
Yes6/ (2nd Progress
Report-Nov. 1986)
(Final Report-
June, 1987)
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 serai-annually
thereafter.
3/ Because of the detection of residues of chlordane, a related cyclodiene pesticide, in urban water systems,
presumably from termiticide uses, additional data requirements have been imposed, which will focus on
the fate of aldrin in the aquatic environment. These are: photodegradation in water, anaerobic soil metabolism
and aerobic aquatic metabolism. Aquatic (sediment) dissipation 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 studies.
4/ A special monitoring study is required, either prospective or retrospective; in which water from sanitary sewers,
sumps, and drainage tiles, draining front home foundations treated with aldrin, is sampled and analyzed
for residues of aldrin. An acceptable protocol must be submitted within 90 days of receipt of this Standard.
5/ Applicator exposure data, must be submitted to support the termiticide use. An acceptable protocol must be submitted
within 90 days of receipt of this Standard.
6/ This requirement was originally imposed as part of the Agency's 1984 Termiticide Data Call-in program. This study is
currently in progress. Further testing may be required pending the results of this study.
5 4
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TABLE A
GENERIC DATA REQUIREMENTS MDR ALDRIN
Data Requirement
§158.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity -
Test
Substance
TGAI
TGAI
Use Does EPA
Patterns Have Data?
H,I No
H,I NO
Bibliographic
Citation
Must Additional
Data be
Submitted?
Yes
Yes
Timeframe
for
Submission1/
9 Months
9 Months
Rabbit
81-3 - Acute Inhalation Toxicity - TGAI
Rat
81-7 - Delayed Neurotoxicity - Hen TGAI
No
No
Yes
N02/
9 Months
SUBCHRONIC TESTING;
82-1 - 9U-Day Feeding: Rodent
and Nonrodent (Dog)
82-2 - 21-Day Dermal - Rabbit
82-3 - 90-Day Dermal - Rabbit
82-4 - 90-Day Inhalation - Rat
82-5 - 90-Day Neurotoxicity
- Hen
TGAI
TGAI
TGAI
TEP
TGAI
Partially
No
No
No
No
00103736
00085416
NoV
ReservedV
NoV
- Mammal
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALDRIN
Data
Requirement
Test
Substance
Use
Patterns
Does
Have
EPA
Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
tor
Submission1/
§158.135 Toxicology (continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity -
Rodent and Nonrodent
83-2 - Onoogenicity -
Mouse
Rat
83-3 - Teratogenicity -
Rat and Rabbit
TGAI
TGAI
TGAI
TGAI
Yes
Yes
No
No
OOU85416, GSU172-UU1 No
GSU172-001
No
Yes
Yes
50 Months^/
(8 Months- Progress
Report)
15 Months
(8 Months- Progress
Report)
83-4 - Reproduction - Rat TGAI h,I
2-generation
MUTAGENICITY TESTING;
84-2 - Gene Mutation (Ames Test) TGAI H,l
84-2 - Structural Chromosomal TGAI h,l
Aberration
84-4 - Other Genotoxic Effects TGAI H,I
No
No
Partially U0123771
Partially OU109564
Yes 39 MonthsJ^/
(8 Months- Progress
Report)
yes7/ll/ 9 Months
12 Months
Yes9/l£/ 12 Months
(9U Days- Acceptable
Protocol )
56
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TABLE A
GENERIC DATA REQUIREMENTS FOR ALDRIN
Data Requirement Test Use Does EPA Bibliographic Must Additional Time frame
Substance Patterns Have Data? Citation Data be tor
Submitted? Submission^/
SPECIAL TESTING:
85-1 - General Metabolism PAI or PAIRA H,I Yes UU151872 NoW
U0151879
I/ Due dates refer to the number of months following receipt of the Registration Standard by the registrant, unless
otherwise indicated.
2/ Aldrin is dissimilar to known delayed neurotoxic agents (i.e., organophosphates) and neurotoxicity ot the delayed
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 trom the exposure area. For these reasons, the Agency is not
requiring this test.
3/ The Agency is not requiring 90-day studies since the Agency has acceptable chronic feeding studies in the rat and
dog, and these supercede the need for subchronic studies.
4/ Requirement for submission of a 21-day dermal study is reserved pending the results of the acute dermal
toxicity study.
5/ The Agency recognizes that aldrin is absorbed dermally and toxicity can ensure from that exposure. However, the
target organs have been well delineated from other routes of exposure and therefore, no data are required for
this area of study.
6/ This requirement was originally imposed as part of the Agency's 1984 Data Call-in Notice. The Agency has
subsequently determined that this study is not necessary, recognizing that absorption of aldrin by the oral route
will suffice to determine the toxic end points or target organs to be determined in a 9U-day inhalation study.
7/ Mammalian cell gene mutation assays, with mouse lymphoma (L5178Y/TK), or Chinese hamster (CHO/V7y/HGPRT) cells
inter alia, specifically comparing activation systems (S9) derived from rat vs. mouse (or hamster) liver microsomes,
are required.
8/ Somatic cell cytogenetic assays, either in vitro or i_n vivo, are required.
57
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALDRIN
§158.135 Toxicology (continued)
9/ The following studies are required:
a. repair in manrnalian cell systems, e.g., primary mouse hepatocytes or established cell lines, by autoradio-
graphic or alkaline elution techniques.
b. adequately controlled promotion assays, e.g., in cell lines already initiated (by viral transformation),
or exposed to known active chemical initiators.
c. mammalian cell transformation in systems with an established data base, e.g., C3H ID Tl/2, BALB 3T3, inter
alia.
d. assays tor mitotic spindle effects (in vitro or in vivo), and/or involving other cellular mechanisms (e.g.,
oncogene activation), inter alia.
e. assays which can distinguish effects on replicative S-phase (scheduled) DMA synthesis from DOS, e.g., in
primary hepatocytes from several species (mouse vs. rat/hamster).
Acceptable protocols for the mitotic spindle effects and mammalian cell transformation tests must be submitted
within 90 days from receipt of the Guidance Document. Protocols for the other tests are not required to
be submitted, since acceptable protocols for these tests can be found in the EPA Guidelines.
It)/ The first progress report is due B months after receipt of this Standard. Interim reports are due semi-annually
thereafter.
ll/ This requirement was originally imposed as part of the Agency's 1984 Special Termiticide Data Call-in Notice.
Data received in response to that DCI were reviewed in conjunction with the development of this
Registration Standard and found to be unacceptable.
12/ This requirement was originally imposed as part ot the Agency's 1904 Special Termiticide Data Call-in Notice.
Acceptable data have been received by the Agency.
58
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ALDRIN
Data
§158.
Requirement Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
145 Wildlife and Aquatic Organisms
Must Additional
Data be
Submitted?
Timeframe
tor
Submission
AVIAN AND MAMMALIAN TESTING:
71-1
71-2
71-3
71-4
- Acute Avian Oral Toxicity TGAI H,I Yes UU020560V
G0111910J/
- Avian Subacute Dietary TGAI H,I Yes 00022923
Upland Game Bird and Waterfowl
- Wild Manual Toxicity TGAI N/A
- Avian Reproduction TGAI H,I No
No
No
Reserved^/
Upland Game Bird and Waterfowl
71-5 - Simulated Field Testing
and Actual Field Testing -
Mammals and Birds
TEP
No
Reserved2/
72-1 - Freshwater Fish Toxicity TGAI H,I
Coldwater and Warmwater
Species
AQUATIC ORGANISM TESTING;
72-2 - Acute Toxicity to TGAI H,l
Freshwater Invertebrates
72-3 - Acute Toxicity to Estuarine TGAI H,I
and Marine Organisms
Yes
Yes
No
U0003503
00003503
No
No
Reserved2/
59
-------
TABLE A
GENERIC UATA REQUIREMENTS FOR ALDRIN
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
tor
Submission
§158.145 Wildlife and Aquatic Organisms (continued)
72-4 - Fish Early Life Stage, TGAI H,l
and Aquatic Invertebrate
Life Cycle
No
Reserved2/
72-5 - Fish - Life Cycle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated Field Testing
and Actual Field Testing
- Aquatic Organisms
SPECIAL TESTING
70-1 Aquatic Residue Monitoring
TGAI
TGAI, PAI or
Degradation
Product
TEP
No
No
No
Reserved^/
Reserved^/
Reserved'*/
No
Reserved^/
V The data cited together will fulfill the data requirement.
J2/ This requirement is reserved pending the results of the special monitoring study, in which water trom sanitary sewer,
sumps, and drainage tiles, draining from home foundations treated with aldrin, is sampled and analyzed for residues
of aldrin.
60
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALDRIN
Data Requirement
Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?_V Citation V Data be tor
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
Ingredients;
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3- Analytical Methods to Verify
Certified Limit
63-4 - Odor
MP
MP
MP
MP
MP
Physical And Chemical Characteristics;
63-2 - Color MP
63-3 - Physical State MP
MP
H,I
H,I
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
61
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALDRIN
Data Requirement
Test
Substance
Use
Does EPA
EPA Bibliographic Must Additional Timetrame
Patterns Have Data?1/ Citation V Data be
Submitted?
tor
Submission?/
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
(continued)
63-7 - Density, Bulk Density, or MP
Specific Gravity
63-12 - pH MP
63-14 - Oxidizing or Reducing MP
Action
63-15 - Flammability MP
63-16 - Explodability MP
63-17 - Storage Stability MP
63-18 - Viscosity MP
63-19 - Miscibility MP
63-20 - Corrosion Characteristics MP
Yes
NoV
Yes
Yes
Yes
Yes
7 Months
7 Months
7 Months
7 Months
16 Months-
(8 Months- Progress
Report)
Yes
Yes
Yes
7 Months
7 Months
7 Months
62
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALDRIN
Data Requirement Test Use Does EPA bibliographic Must Additional Timeframe
Substance Patterns Have Data?V Citation V Data be tor
Submitted? Submission2/
Other Requirements;
64-1 - Submittal of MP H,I ReservedV
Samples
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.
2/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
3/ The technical (T) also serves as a manufacturing-use product, since aldrin is not manufactured in the United
States of America. All formulation intermediates are included in the category of manufacturing-use products.
4/ Not required since aldrin is practically insoluble in water.
5/ If samples are needed, the Agency will request them.
63
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING ALDRIN
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional Timeframe
Citation Data be foe-
Submitted? Submission^/
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat MP H,I No
- Acute Dermal Toxicity MP 2/ H,I No
- Rabbit
- Acute Inhalation Toxicity MP H,I No
- Rat
- Primary Eye Irritation MP H,I No
- Rabbit
- Primary Dermal Irritation MP H,I No
- Rabbit
- Dermal Sensitization MP H,I No
- Guinea Pig
Yes
Yes
Yes
Yes
Yes
NqV
9 Months
9 Months
9 Months
9 Months
9 Months
I/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ The technical (T) also serves as a manufacturing-use product since aldrin is not manufactured in the united States
of America. All formulation intermediates are included in the category of manufacturing-use products.
3/_ Due to the extensive human exposure data compiled without reported detmal sensitization, testing is not required.
64
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING ALDRIN
Guideline Citation and Name of Test Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data?V CitationV Data be for
Submitted? Submission2/
§158.120 - Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure EP H,I
of Ingredients
61-2 - Description of Beginning Materials EP H,I
and Manufacturing Process
61-3 - Discussion of Formation of EP H,I
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis EP H,I
62-1 - Certification of Limits EP H,I
62-3 - Analytical Methods to Verify EP H,I
Certified Limit
Physical and Chemical Characteristics
63-2 - Color EP H,I
63-3 - Physical State EP H,I
63-4 - Odor EP H,I
63-7 - Density, Bulk Density, or EP H,I
Yes b Months
Yes 6 Months
Yes 6 Months
Yes 12 Months
Yes 6 Months
Yes 6 Months
Yes fo Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Specific Gravity
65
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING ALDRIN
Guideline Citation and Name of Test Test Use Does EPA Bibliographic Must Additional Timetrame
Substance Patterns Have Data?V Citation*/ Data be for
Submitted? Submission^/
§158.120 - Product Chemistry (continued)
Physical and Chemical Characteristics
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
63-21 - Dielectric Breakdown Voltage
Other Requirements:
64- 1 Submittal of Samples EP,
(continued)
EP H,I
EP H,I
EP H,I
EP H,I
EP H,I
EP H,I
EP H,I
EP H,I
EP H,I
TGAI, H,I
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 12 Months
Yes b Months
Yes 6 Months
Yes 6 Months
No3
Reserved4/
PAI
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data must
be resubnitted for each pesticide. New requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
3/ Not required because product Labels caution to avoid use near electrical equipment.
4/ If samples are needed, the Agency will request them.
66
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING ALDRIN
Guideline Citation and Name of Test Test Use Does EPA
Substance Patterns Have Data?
Bibliographic Must Additional Timeframe
Citation Data be foe
Submitted? Submissionl/
§158.135 Toxicology
z
Acute Testing;
81-1 - Acute Oral Toxicity - Rat EP
81-2 - Acute Dermal Toxicity EP
- Rabbit
81-3 - Acute Inhalation Toxicity EP
- Rat
81-4 - Primacy Eye Irritation EP
- Rabbit
81-5 - Primary Dermal Irritation EP
- Rabbit
81-6 - Dermal Sensitzation EP
SPECIAL TEST
Guinea Pig Inhalation Study EP
NO
No
NO
No
NO
NO
No
Yes
Yes
Yes
Yes
Yes
No2/
Yes3/
9 Months
9 Months
9 Months
9 Months
9 Months
15 Months
(90 Days-Acceptable
Protocol)
(8 Months- Progress
Report)
T7Due dates refer to the number of months following receipt of this Registration Standard by the registrant, unless
otherwise indicated.
2/ Due to the extensive human exposure data compiled without reported dermal sensitization, testing is not
required.
2/ Testing is required to delineate the irritative capabilities to mucous membranes of aldrin, the solvent, and/or
the combination. The study design must include a 7-day exposure period to two groups of guinea pigs, with a
2-week recovery in one group; the second to be sacrificed after 7 days of exposure. Exposures should be for 6-8
hrs/day at levels found in a house on day 1 of tetmite treatment and include end-use solvent alone; aldrin
alone, and solvent plus aldrin. Registrants of products containing the same or similar solvents are encouraged
to develop data jointly.
67
-------
II. LABELING APPENDICES
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. • COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
69
-------
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 I62.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
70
-------
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 162.1l(c). You will be notified of
the Agency's classification decision.
71
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so-, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
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.
73
-------
SUMMARY.-6
LABELING REQUIREMENTS OF THE FIFRA, 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 /gal Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs .
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed 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
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precau tionary
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.
75
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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
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product In a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
ADOMESTCAMMAL8
CAUTION
ENVMONMENTAL HAZARDS
PHV8CALORCHEMCAL
HAZARDS
DnEonoNSPOfiusE
• *MM *
fradurt li •
RE-CHTRV STATEMENT
CROP:
CROP:.
CROP:
PRODUCT
NAME
ACTIVE MQREOCNT: ,
MERT MOREOCNTS:.
TOTAL:
ft
ft
10000ft
TH8 PRODUCT CONTAMS IBS OF PEROAUON
KEEP OUT OF REACH OF CHILDREN
CAUTION
STATEMENT OF PRACTICAL TREATMENT
r SWALLOWED:
FMHALEDS=
SEE 801 PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
UFOBY==
TOWN. STATE ==
ESTABUSHMENTNO.:
EPA REGISTRATION NO.:
NET CONTENTS:
STORAGE AND
DISPOSAL
STORAGE:
DISPOSAL:
WARRANTY STATEMENT
-------
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
(I OOMESTC ANIMALS)
DANGER
ENVMONMENTAL HAZARDS
PHV9CALORCHEMCA1
HAZARDS
OmECTONSFORUSE
k • «oMMi of ftiftt kw to m»
n % MWW MiQonwBlQni
RE-ENTRY STATEMENT
STORAGE AND
' DISPOSAL
DBPO8AL;
CROP:
CROP:
RESTRICTED USE
PESTICIDE N
(reason for clnsnlfyinp)
JWRBIMt Vu£ TO MID USC CHUT 8T CBtnniD APPUCMOB OR
S2°2. ""^ TMBIR OIRB:P WFOWISIOM AND ONLY FOR THOSE
(BBS OOVBCD BT THE CEKTiriBD APPUCMOR'8 CERTIFICATION
CROP:;
PRODUCT
NAME
ACTIVE MQREDCNT:
NERT WOREDIENTS. .
TOTAL:
10000%
THIS PRODUCT CONTAMS IBS OF PER GALLON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
CROP:
CROP:
STATEMENT OF PRACTICAL TREATMENT
CROP:
r SWALLOW
PMHALEO:
FONSKM:
r M EYES :
SEE 8DE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS
MFO BY:
TOWN. STATE
ESTABLISHMENT NO.:
EPA REGISTRATION NO.:
WARRANTY STATEMENT
NET CONTENTS:
78
-------
§ 16X10
it obtained the data from
(Identify): applicant copied
a publication: applicant ob
of the data from EPA).
The *ppllnnt «H«H submit
his ^ppllfatlon a statement that
la luevaluatton of the
cacy.\and safety of the fonnV
product, may not <
supporting the apply
following data:
except
(1)
mitted
tttim
(2)
safety of
ents.
end-use
(3)
regulations.
clean
Food. Drug, i
(e) If the i
Item of data
section wasi
pense of) i
ly submitted thei
predecessor.
ary 1. 1970. to
tor registration.
permit, or
use to an
data the applicant,
EPA under i
i sub-
(b> of
data
product's
than to the.
ice*
• talc
notions
Uiekat
to the
Ingredl-
Sfety of the
/ood additive
and other
the Federal
!ACt.
that any
ted under this
' (or at the ex-
i who original-
to EPA (or Its
(on or after Janu-
an application
adding
the
terms1
that)
a new
or (or
applicant
Itter have
on the
payment of
be pay-
section
reregistration
and the
reached wrli
amount **"*
any
able
3(cXl)(OXU)/wlth regard\to approval
of the application}, the applicant shall
submit to EPA a statement that he
has furnlsoed to each such\ Identified
original dsjta submitter:
(1) A notification of the applicant's
Intent to,
lag the
(2)
• for registration includ-
product
offer to pay the persoa com-
. with regard to the
of the/ application, to the
by FTFRA sections 3
-------
9 162.10
(Iv) The product nftrtntlon
number u prescribed In paragraph <•)
of thto aectlon;
(v) The producing establishment
number u prescribed In paragraph of this sec-
tion;
(vll) Warning or precautionary state-
ments as prescribed In paragraph (h)
of thb section;
(vlll) The directions for use as pre-
scribed In paragraph of thto section:
and
(Ix) The use classification^) as pre-
scribed In paragraph (J) of thto section.
(1) Prominence and legibility. (I) All
words, statements, graphic representa-
tions, deafens or other Information re-
quired on the labeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vblon, and must be placed with such
complciiotisness (as compared with
other words, statements, design*, or
graphic matter on the labeling) and
expressed In such terms as to render It
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
of the
Act. a pesticide or a device declared
subject to the Act pursuant to
1162.15. to mbbranded If Its labeling to
false or misleading In any particular
Including both pestlcldal and non-pes-
tlcldal claims. Examples of statements
or representations In the labeling
which constitute tnbbrandlng Include:
(I) A false or misleading statement
concerning the composition of the
product:
(II) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(III) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device; i
(Iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or Indi-
rectly Implying that the pesticide or
device to recommended or endorsed by
211
Chapter I—Environmental Protection Agency
9 162.10
any agency of the Federal Govern-
ment:
(vl) The name of a pesticide which
contains two or more principal active
Ingredients If the name suggests one
or more but not all such principal
active Ingredients even though the
names of the other Ingredients are
stated elsewhere In the labeling;
(vll) A true statement used In such a
way as to give a false or misleading Im-
pression to the purchaser:
(vlll) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions:
(Ix) Claims as to the safety of the
pesticide or Ita IngredlrnLi. Including
statements such as "safe," "nonpobon-
oiis,*' "nonlnjurloiis." "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
(A) "Contains all natural Ingredi-
ents":
(B) "Among the leant toxic chemi-
cals known"
• (C) "Pollution approved"
(6) Final printed labr.llng. (I) Except
as provided In paragraph (aNOKll) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(II) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers qr large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product to sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(U Is false or misleading, or
(II) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to I l83.6(bM4).
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
drem given on the label shall be con-
sidered as the name and address of the
producer. If the registrant'* name ap-
pears on the label and the registrant b
not the producer, or If the name of the
person for whom the pesticide was
produced appears on the label. It must
be qualified by appropriate wording
such as "Packed for * • V "Dbtrlhut-
ed by • • V or "Sold by to show
that the name b not thai of the pro-
ducer.
(d) Net weight or mnuurr of eon-
Irnts. (I) The net weight or measure
of content shall be exclusive of wrap-
pers or other materlab and shall be
thn average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide b a liquid, the
net content statement shall be In
terms of liquid measure at 68" F (20*C)
and shall be expressed In conventional
American units of fluid ounces, pints.
quarts, and gallons.
O) If the pesticide b solid or semton-
lid. vlscoun or pressurized, or b a mix-
ture of liquid and solid, the net eon-
tent statement shall be In terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated In terms of the largest suitable
units. I.e.. "1 pound 10 ounces" rather
than "26 ounces."
(B) In addition to the required units
specified, net content may be ex-
pressed In metric units.
(6) Variation above minimum con-
tent or around an average to permissi-
ble only to the extent that It repre-
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum Is not permit-
ted. In no case shall the average eon-
tent of the packages In a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the lime of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
set In type of a size and style similar to
other print on that part of the label
on which It appears and shall run par-
-------
{162.10
allel to It. The registration number
and the required Identifying phnuw
•hall not appear In such a manner as
to aliment or Imply recommendation
or endomement of the product by the
Agency.
Producing estobflsAsseNli revfa-
f ratio* number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA EM.", 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 stafemeiif—(1) Gener-
al The label of each pestldde product
must bear a statement which contains
the name and percentage by weight of
each active Ingredient, the tola! per-
centage by weight of all Inert Ingredi-
ents; and If the pestldde contains ar-
senic In any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term "active Ingredi-
ents" and the Inert Ingredients by the
term "Inert Ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" Is
not required for pesticides which con-
tain 100 percent active Ingredients.
Unless the Ingredient statement Is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
<2) Potillon of ingredient statement
(I) The Ingredient statement to nor-
mally required on the front panel of
the labrl. If there Is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the stxe 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.
111) The test of the Ingredient state-
ment must run parallel with other
test on the panel on which It appears.
and must be clearly distinguishable
from and must not be placed bi the
body of other text
O) Names to be msed <• l»grredie*f
•tafrment The name used for each In-
gredient shall be the accepted
common name. If there b one. fol-
lowqrl by the chemical name. The
common name may be used alone only
If It to well known. If no common name
has been established, the chemical
name alone shall be used. In no cane
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 2SS-25%." If
the uses of the pestldde product are
espressed as weight of active Ingredi-
ent per unit area, a statement of the
wrlghl of active Ingredient per unit
volume of the pesticide formulation
shall also appear In the Ingredient
statement.
(6) Accuracy of staled percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may or un-
avoidable variation between manufac-
turing batches, the value stated for
each active Ingredient shall be the
lowest percentage which may be pres-
ent.
10) Deterioration. Pestlddea which
change In chemical composition sig-
nificantly must meet Uie following la-
beling requirements:
(I) In cases where It to determined
that a pestldde formulation changes
chemical composition significantly.
the product must bear the following
statement In a prominent position on
the label: "Not for sale or use after
Idatel."
til) The product must meet all label
claims up to the expiration time Indi-
cated on the label.
<7) Inert inoredienCn The Adminis-
trator may require the name of any
Inert IngredlenUs) to be listed In the
Ingredient statement If he determines
that such tngmUenUs) may pose a
hazard to man or the environment.
Warning* and precaMfloaary
statements. Required warnings and
precautionary statements concerning
the general areas of toiteologtcal
hazard Including hazard to children.
environmental hazard, and physical or
chemical hazard fall Into two groups;
those required on the front panel of
the labeling and those which may
9 1*2.10
appear elsewhere. Sprrffle require-
ments concerning content, placement.
type state, and promlnrnrr arc given
(1) Jtrontmt front panel stolrmrnt*.
With the exception of thr child
hazard warning statement thr trxt re-
quired on the front panel of thr labrl
to determined by the Tnslrlty Ifetrgo-
ry of the pestldde. Thr category Is as-
signed on the baste of the hlghrst
hazard shown by any of thr Indicators
In the table below.
• 70.000
30
81
(I) Human Hazard signal word-
-------
§ lei.10
oil treatment ta some reference such
as "See statement of practical treat-
menl on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
frt •> OIOQ. on OMB. * at
OOMnfl lAflWapnMV •• ••• MMoMOTlB) W|gVVJB.|.
OB not 0* »< fim. on Mln. 01 en
doNnt, Mov 0oggh* or ton oM*l m* iubb«r
SbMi «tan tandki*. HmM a hM • cmRgMd
(ApproprM. an oU oM-Mni nxMvJ I
i oio l«n» ottil IrtlpHiii, Do not gM H ojo*,
|Ap-
on thK 0> on cM** HnrmU I mm^umwt
••ft •**, oyoi 01 CM** to cow of
If a pesticide Intended for out-
door use contains an active Ingredient
with a mammalian acute oral LD» of
100 or less, the statement "This Pesti-
cide Is Toxic to Wildlife" b required.
(B> If a pesticide Intended for out-
door use contains an active Ingredient
with a fish acute LC.. of I ppm or Iras.
the statement "This Pesticide Is Toxic
to Fish" Is required.
(C) If a pesticide Intended for out-
door use contains an active Ingredient
with an avlan acute oral LD« of 100
mg/kg or less, or a siibacnte dietary
LCM of 500 ppm or leas, the statement
"This Pesticide Is Toxic to Wildlife" la
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
§ 169.10
"This pesticide Is extremely toxic lo
wildlife (fish)" Is required.
(E) For uses Involving foliar applica-
tion to agricultural crop*, forest*, or
shade trees, .or for mosquito abate-
ment treatments, pesticides Ionic lo
pollinating Inserts must bear appropri-
ate label rail) Ions.
(F) For all outdoor uses other than
aquatic applications the label must
bear (he caution "Keep out of lakes.
ponds or streams. Do not ronlnmlnale
water by cleaning of equipment nr dis-
posal of wastes."
Oil) rhyilcat or chrmlfal hazards
Warning statements on I he flammnbll-
lly or explosive characteristics of I IIP
pesticide are required as follows:
lnhpoM
____ _ |
W pnuswwro Comwrns
rinft ran M o> Mo» so- r. » Im b • InMlocli
Finn poHithav. 20-roj«fiiolo«irMrFoT«fto
«l Oh* po
»«. ipirtk *ad h
*, fmrm K~P my kom
On nrt pinr*»> n Inrinvnw
r mny I'mna
Ccnt*nH under prcmw* KM» omr knm
ond op«n Item Do no) pirnluni Of t»*m«m ran
* to wmpwdim okoM in' r m «&• mm hMl v npp
- Oo rat punckra or kickifilto cmil»t»» Fipnw* <
•*-— -^evo 139- F my e*n» • "
Mot
Miooo 90-F ona not ew M-F
MBOW MT F ml not ant ISO- F
-------
9 U2.10
(J) The label clearly shorn that the
product la Intended for uae only In
manufacturing processes MM! specifies
the typefs) of products Involved.
(2) Adequate Information such as
technical data sheets or bulletins. Is
available to the trade specifying the
type of product Involved and Its
proper use In manufacturing process-
es;
(J) The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
ucts; and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fectfl on man or the environment.
Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale Is limited
to physicians, veterinarians, or drug-
gists, provided that:
I J) The label clearly states that the
product to for uae only by physicians
or veterinarians:
<2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(J) The product to also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are Intended for
use only by formulatoia In preparing
pesticides for sale to the public, pro-
vided that:
(J) There to Information readily
available to the formulators on the
composition, toxlclly. methods of use.
applicable restrictions or limitation)).
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product to Intended for use only In
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the typeis) of pesticide prod-
ucts Involved;
(3} The product as finally manufac-
tured, formulated, mixed, or repack-
aged to registered; and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
THIo 40—frotoctton •* Environment
(1) Content* a/ Directions for Use.
The directions for use shall Include
the following, under the headings "Di-
rections for Use":
(I) The statement of use classifica-
tion as prescribed In 162.101J) Immedi-
ately under the heading "Directions
for Use."
(Jl) Immediately below the state-
ment of use classification, the state-
mrnt "It to a violation of Federal law
to use this product In a manner Incon-
sistent with Its labeling."
The sllets) of application, as for
example the crops, animals, areas, or
objects to be treated.
The method of application. In-
cluding Instructions for dilution. If re-
quired, and type(s) of application ap-
paratus or equipment required.
(vlll The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(vlll) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 110.
(Ix) Specific directions concerning
the storage and disposal of the pesti-
cide and Its container, meeting the re-
quirements of 40 CFR Part 165. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set In type of the same minimum allies
as required for the child hazard warn-
ing (See Table In 1162.10(hXlXlvU
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required Intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
In or adjacent to certain areas.
(Reserved]
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who to not phys-
ically present at the site of application
0)»
Chapter I—Environmental Protection Agency
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who to physically present.
(F) Other pertinent Information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(J) Statement of Uie Ctatstftcation.
By October 23. 1079. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
In paragraphs (JM1) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth In this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use(s) and the other
bearing directions for restricted tisHs)
except that. If a product has both re-
stricted iisc(s) and general use. both
of these uses may appear on a product
labeled for restricted use. Such prod-
ucts shall be subject to the provisions
of | I62.10(JX2>.
(I) Grnrrof Ute Clatti/lcatton. Pesti-
cide products bearing directions for
tisc(s) classified general shall be la-
beled with the exact words "General
Cliuslllcatlon" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Usq will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) RcttrlcleA Ute CIuMl/lcaffon.
Pesticide products bearing direction
for nselUrla for drtrri
m of i
rmmnnablc •d*rm* effect*.
Issuance of Nnttfr nf
lntr.nti.to Deny Registration, Onncrl
Registration, or to Holit a llejtrlng •
(1) rre.\mptton. (l> A rebullaAle pre-
sumptlorXshall arise that a /ollce. of
Intent to oeny registration mrsiiant to
section 3(c\0) of the Act.ya notice of
Intent to cancel registration pursuant
to section 6fbXI> of t/c Act. or a
notice of Intent lo h
determine whc
should be cancel
proprlate. shall
termination by tl
Ihe pesticide
the criteria for
graph
-------
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 13 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.
-------
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.
85
-------
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)
V Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
86
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must contain
the statement, "Do not contaminate water, food, or feed by storage
or disposal."
2. Except those products intended solely for domestic use, the
labels of all products that contain active ingredients that are
Acute Hazardous Wastes (see list in this Appendix) or are assigned
to Toxicity Category I on the basis of oral or dermal toxicity,
skin or eye irritation potential, or Toxicity Category I or II
on the basis of acute inhalation toxicity must bear the following
pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a violation
of Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
3. The labels of all products, except those intended for domestic
use, containing active or inert ingredients that are Toxic Hazardous
Wastes (see list in this Appendix) or meet any of the criteria
in 40 CFR 261, Subpart C for a hazardous waste must bear the
following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according
to label instructions, contact your State Pesticide or 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."
87
-------
PEST/DIS-2
POOS
P070
P004
POOS
P006
POOS
P010
P011
P012
P021
P022
P024
P030
P031
P037
P039
P040
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4
297-97-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with RCRA | and CAS *
[40 CFR 261.33(e)J
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
Hex achlorohex ahyd ro-ex o,exo-
dimethanonaphthalene (Isodrin)
Hydrocyanic acid
Methomy1
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
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8
88
-------
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
39195-18-4
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
pen tachlorophenox ide
Erbon F027
0-ethyl 0-(2,4,5-trichlorophenyl)
ethylphosphonothioate F027
2,2'-nMethylenebis 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
(Ci5~Ci8)~lf3-propanediamine
—Pentachlorophenyl laurate F027
Potassium trichlorophenate (2,4,6) F027
Potassium trichlorophenate (2,4,5) F027
Silvex F027
—2-Butoxyethyl ester F027
—Butoxypolypropoxypropyl ester F027
—Butoxypropyl ester F027
—Diethanolamine salt F027
—Diisopropanolamine salt F027
—Dimethylamine salt F027
—Dipropylene glycol isobutyl F027
ether ester
—Ethanolamine salt F027
—2-Ethylhexyl ester F027
—Isooctyl ester F027
5324-22-1
35109-57-0
136-25-4
327-98-0
70-30-4
67923-62-0
3247-34-5
5736-15-2
87-86-5
7778-73-6
131-52-2
2917-32-0
3772-94-9
2591-21-1
35471-43-3
93-72-1
19398-13-1
53404-07-2
25537-26-2
51170-59-3
53404-09-4
55617-85-1
53535-26-5
7374-47-2
53404-76-5
53404-14-1
89
-------
PEST/DIS-4
—Isopropanolamine salt F027
—Monohydroxylaluminum salt F027
—Polypropoxypropyl ester F027
—Potassium salt F027
—Propylene glycol isobutyl F027
ether ester
—Sodium salt F027
—Triethanolamine salt F027
—Triethylamine salt F027
, —Triisopropanolamine salt F027
—Tripropylene glycol isobutyl F027
ether ester
Sodium 2-(2,4,5-trichlorophenoxy) F027
ethyl sulfate
Tetrachlorophenols F027
—Alkylamine*amine salt (as in F027
fatty acids of coconut oil)
—Potassium salt F027
—Sodium salt F027
2,4,5-Trichlorophenol F027
2,4,6-Trichlorophenol F027
2,4,5-Trichlorophenol salt of F027
2,6-bis[(dimethylamino)methyl]
cyclohexanone
2,4,5-Trichlorophenol, sodium salt F027
2,4,6-Trichlorophenol, sodium salt F027
2,4,5-Trichlorophenoxyacetic acid F027
—Alkyl C-12 amine salt F027
—Alkyl C-13 amine salt F027
—Alkyl C-14 amine salt F027
—N,N-diethylethanolamine salt F027
—Dimethylamine salt F027
—N,N-dimethyllinoleylamine salt F027
—N,N-dimethyloleylamine salt F027
—N-oleyl-1,3-propylene F027
diamine salt
—Sodium salt F027
—Triethanolamine salt F027
—Triethylamine salt F027
--Alkyl (C3H7 - C7H9) ester F027
—Amyl ester F027
—Butoxyethoxypropyl ester F027
—2-Butoxyethyl ester F027
—Butoxypropyl ester F027
—Butyl ester F027
—Dipropylene glycol isobutyl F027
ether ester
—2-Ethylhexyl ester F027
—Isobutyl ester F027
53404-13-0
69622-82-8
83562-66-7
2818-16-8
53466-84-5
37913-89-6
17369-89-0
53404-74-3
53404-75-4
53535-30-1
3570-61-4
25167-83-3
53535-27-6
25567-55-9
95-95-4
88-06-2
53404-83-4
136-32-3
3784-03-0
93-79-8
53404-84-5
53404-85-6
53535-37-8
53404-86-7
6369-97-7
53404-88-9
53404-89-0
53404-87-8
13560-99-1
3813-14-7
2008-46-0
120-39-8
1928-58-1
2545-59-7
1928-48-9
93-79-8
53535-31-2
1928-47-8
4938-72-1
90
-------
PEST/DIS-5
—Isopropyl ester F027
—Propylene glycol isobutyl F027
ether ester
—Tripropylene glycol isobutyl F027
ether ester
4-(2,4,5-Trichlorophenoxy)butyric F027
acid [2,4,5-TB]
2-(2,4,5-Trichlorophenoxy)ethyl F027
hydrogen sulfate [2,4,5-TES]
1,4',5'-Trichloro-2'-(2,4,5- F027
trichlorophenoxy)
methanesulfonanilide [Edolan U]
93-78-7
53466-86-7
53535-32-3
93-80-1
69633-04-1
69462-14-2
91
-------
PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST (with
[40 CFR 261.33(f)]
Acetone
Acryloni tr ile*
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 ) (d iallate, Avadex )
o-Di chlorobenzene*
p-Dichlorobenzene*
Die hlorodif luorome thane
(Freon 12®)
3,5-Dichloro-N-(l,l-dimethyl-2-
propynyl) benzamide
(pronamide, Kerb®)
Dichloro diphenyl dichloroethane
(ODD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2, 4-Dichlorophenoxyacetic,
salts and esters (2,4-D)*
1 f 2-Dichloropropane
lf 3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
(l-chloro-2, 3-epoxypropane)
Ethyl acetate
Ethyl 4,4 '-dichlorobenzilate
(chlorobenzilate)
RCRA #,
U002
U009
U011
U019
U028
U136
U211
U034
U036
U037
U039
U044
U048
U051
U052
U056
U057
U142
U066
U069
U062
U070
U072
U075
U192
U060
U061
U025
U240
U083
U084
U102
U041
U112
U038
and CAS |
67-64-1
107-13-1
61-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0
57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
96-12-8
84-74-2
2303-16-4
95-50-1
106-46-7
75-71-8
23950-58-5
72-54-8
50-29-3
1191-17-9
94-75-7
8003-19-8
542-75-6
131-11-3
106-89-8
141-78-6
510-15-6
*Proposed for deletion by TCLP proposal
92
-------
PEST/DIS-7
Ethylene dibromide (EDB)
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
93
-------
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
94
-------
III. USE INDEX APPENDIX
95
-------
EPA Compendium of Acceptable Uses
c045101 ALDRIN*
TYPE PESTICIDE: Insecticide
FORMULATIONS:
FI
EC
(25%)
(2 Ib/gal,
4 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE PESTICIDE.
Aldrin is toxic to fish and wildlife. Keep out of lakes, streams or
ponds. During commercial or prolonged exposure in spraying, mixing and
loading operation, wear clean rubber gloves. Wear a respirator jointly
approved by the Mining Enforcement and Safety Administration (formerly the
U.S. Bureau of Mines) and by the National Institute for Occupational Safe-
ty and Health under the provisions of 30 CFR Part II for aldrin protec-
tion. Do not apply aldrin in or around poultry houses, barns, silos, milk
houses or other structures where livestock or poultry are held, or where
food or feed is stored, prepared, or processed.
Agricultural Crop Tolerances;
Alfalfa
Apples
Apricots
Asparagus
Barley, Grain
Barley, Straw
Beans
Beets, Carden
Beets, Garden, Tops
Beets, Sugar
Beets, Sugar, Tops
Broccoli
Brussels Sprouts
Cabbage
Cantaloups
Carrots
Cauliflower
Celery
Cherries
Clover
Collards
Corn, Forage
Corn, Grain
Corn, Pop
Cowpeas
Cowpeas, Hay
Cranberries
Cucumbers
Eggplant
Endive (Escarole)
Garlic
Grapefruit
Grapes
0.0 ppm
0.0 ppm
0.0 ppm
0.1 ppm
0.02 ppm (interim)
0.1 ppm (interim)
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.0 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.0 ppm
0.0 ppm
0.05 ppm (interim)
0.1 ppm
*hexachlorohexahydro-endo, exo-dimethanonaphthalene 95% and related com-
pounds 5%
Issued: 8-29-84
Provisional Update: 8-25-86
III-045101-1
96
-------
EPA Compendium of Acceptable Uses
ALDRIN
GENERAL WARNINGS AND LIMITATIONS (continued)
Horseradish
Kale
Kohlrabi
Leeks
Lemons
Lespedeza
Lettuce
Limes
Mangoes
Muskmelons
Mustard, Greens
Nectarines
Oats, Grain
Oats, Straw
Onions
Oranges
Parsnips
Peaches
Peanuts
Peanuts, Hay
Pears
Peas
Peas, Black-eyed
Peas, Cowpeas
Peas, Hay
Peppers
Pimentos
Pineapples
Plums (Fresh Prunes)
Potatoes
Pumpkins
Quinces
Radishes
Rice, Grain
Rice, Straw
Rutabagas
Rye, Grain
Rye, Straw
Salsify, Roots
Salsify, Tops
Shallots
Sorghum, Forage
Sorghum, Grain
Soybeans
Soybeans, Hay
Spinach
Squash, Summer
Squash, Winter
Strawberries
Sweet Potatoes
Swiss Chard
Issued: 8-29-84
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.05 ppm
0.0 ppm
0.1 ppm
0.05 ppm
0.1 ppm
0.1 ppm
0.0 ppm
0.1 ppm
0.02 ppm
0.1 ppm
0.0 ppm
0.05 ppm
0.0 ppm
0.1 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.0 ppm
0.0 ppm
0.05 ppm
0.1 ppm
0.0 ppm
0.02 ppm
0.1 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.0 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.1 ppm
0.0 ppm
(interim)
(interim)
(interim)
(interim)
(interim)
(interim)
(interim)
(interim)
(Interim)
III-045101-2
97
-------
EPA Compendium of Acceptable Uses
ALORIN
GENERAL WARNINGS AND LIMITATIONS (continued)
Tangerines
Tomatoes
Turnips
Turnips, Tops
Watermelons
Wheat, Grain
Wheat, Straw
0.05 ppm (interim)
0.1 ppm
0.0 ppm
0.0 ppm
0.1 ppm
0.02 ppm (interim)
0.1 ppm (interim)
Site and Pest
DOMESTIC OUTDOOR
Dosages and Tolerance, Use, Limitations
Formulation(s)
/64000NA
ntGDAGA
(Wood or Wood Structure Protection Treatments)
Terrestrial Structures
Subterranean ter-
mites (including
Coptotermes,
Heterotermes,
Reticulltermes,
and Zootermopsis
spp.)
0.25-0.5Z
emulsion
(2, 4 Ib/gal
EC)
Soil contact wood protection treat-
ment.
Use limited to professional pest
control operators. Apply the lower
dosage (0.25 percent emulsion) for
structures which should be inspected
annually for possible reinfestation
and retreatment if necessary. The
higher dosage (0.5 percent emulsion)
will give up to 8 years or more pro-
tection when used as directed. An-
nual reinspection is desirable to
check areas possibly missed during
initial treatment. These formula-
tions are designed for treatment of
soil to establish a barrier which
is lethal to termites. Aldrln must
be adequately dispersed in the soil
to provide a barrier between the
wood in the structure and the ter-
mite colonies in the soil or to con-
trol termites living in the struc-
ture.
It is necessary for the effective
use of aldrin that the service tech-
nician be familiar with current con-
trol practices including trenching,
redding, subslab injection, and low
pressure spray application. These
techniques must be correctly employ-
ed to prevent or control infesta-
tions by subterranean termite spe-
Issued: 8-29-84
III-045101-3
98
-------
EFA Compendium of Acceptable Uses
ALDRIN
Site and Pest Dosages and Tolerance, Use, Limitations
Fonnulation(s)
Terrestrial Structures (continued)
cies of Coptotermes, Heterotermes,
Reticulitermes and Zooternopsis.
Choice of appropriate procedures in-
cludes consideration of such vari-
able factors as the design of the
structure, water table, soil type,
soil compaction, grade conditions
and location and type of domestic
water supplies. The biology and be-
havior of the involved termite spe-
cies 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
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 nonessentla1 wood and cellulose
containing materials, including
scrap wood and form boards, should
be removed from around foundation
walls, crawl spaces, and porches.
Issued: 8-29-84 III-045101-4
99
-------
EPA Compendium of Acceptable Uses
ALDRIN
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Terrestrial Structures (continued)
FRECONSTRUCTION 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.
1. 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.
Issued: 8-29-84 III-OA5101-5
100
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Site and Pest
EFA Compendium of Acceptable Uses
ALDRIN
Dosages and Tolerance, Use, Limitations
Formulations) '
Terrestrial Structures (continued)
2. 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.
3. 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.
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.
Issued: 8-29-84
III-045101-6
101
-------
EPA Compendium of Acceptable Uses
ALDRIN
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Terrestrial Structures (continued)
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-
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.
Issued: 8-29-84 III-045101-7
102
-------
Site and Pest
EPA Compendium of Acceptable Uses
ALDRIN
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
Terrestrial Structures (continued)
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.
2. 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.
3. For basements apply at the rate
of 4 gallons of emulsion per 10
linear feet. Where footings are
greater than 1 foot of depth
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
walls, 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.
Issued: 8-29-84
III-045101-8
103
-------
EPA Compendium of Acceptable Uses
ALDRIN
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Terrestrial Structures (continued)
a. Rod holes should be spaced
(about 1 foot) to provide a
continuous chemical barrier.
b. Trench need not be wider
than 6 inches nor below the
foundations. The emulsion
should be mixed with the
soil as it is replaced in
the trench. Cover the
treated soil with a layer
of untreated soil.
c. Do not apply in any manner
to an area intended as a
plenum air space. After
treatment, securely plug all
holes drilled in construc-
tion elements.
d. Do not apply as an overall
treatment to soil in crawl
spaces.
All holes drilled in construction
elements for treatment should be
securely plugged.
RETREATMENT RESTRICTIONS
Retreatment for subterranean ter-
mites should only be made when there
is evidence of reinfestations subse-
quent to the Initial treatment, or
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.
INDOOR
(Wood or Wood Structure Protection Treatments)
/64000IIA Terrestrial Structures
Refer to DOMESTIC OUTDOOR, (Wood or Wood Structure
Protection Treatments), Terrestrial Structures.
Issued: 8-29-84 HI-045101-9
104
-------
EPA Compendium of Acceptable Uses
ALDRIN
Listing of Registered Pesticide Products by Formulation
&025.0002 25% formulation intermediate
aldrin (045101)
002459-00201*
^suspended
&102.0012 2 Ib/gal emulsifiable concentrate
aldrin (045101)
037686-00005
aldrin (045101) plus aromatic petroleum distillate (006601)
001842-00163 001842-00282
&104.0012 4 Ib/gal emulsifiable concentrate
aldrin (045101)
001927-00022
aldrin (045101) plus aromatic petroleum derivative solvent (006501)
001022-00220 009859-00254*
*suspended
aldrin (045101) plus heavy aromatic naphtha (006602)
006720-00188
aldrin (045101) plus petroleum distillate (063503)
003743-00308 008915-00002
aldrin (045101) plus xylene (086802)
001842-00134
aldrin (045101), kerosene (063501) plus xylene (086802)
004887-00027
Issued: 8-29-84
III-045101-10
105
-------
IV. BIBLIOGRAPHY APPENDICES
106
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources Cor studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
107
-------
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.
108
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Aldrin Standard
00003503 Johnson, W.W.: Finley, M.T. (1980) Handbook of Acute
Toxicity of Chemicals to Fish and Aqiatic Invertebrates.
U.S. Dept. of the Interior/ Fish and Wildlife Service,
Resource Publication 137:134.
00020560 Schafer, E.W. (1972) The acute oral toxicity of
369 pesticidal, pharmaceutical and other chemicals
to wild birds. Toxicology and Applied Pharmacology
21(? ):315-330. (Also In unpublished submission
received Apr 25, 1978 under 476-2180; submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:233577-C)
00022923 Hill, E.F.; Heath, R.G.: Spann, J.S.; et al. (1975)
Lethal Dietary Toxicities of Environmental Pollutants
to Birds: Special Scientific Report—Wildlife No. 191.
(U.S. Dept. of the Interior, Fish and Wildlife Service,
Patuxent Wildlife Research Center; Unpublished report)
00059894 Treon JF and Cleveland FP. 1955, Toxicity of
certain chlorinated hydrogen insecticides for
laboratory animals, with special reference to aldrin
and dieldrin. Agric. Food Chem. 3:402-408.
00072077 Treon, J.F.; Cleveland, P.P. (1954) The Toxicity of
Certain Chlorinated Hydrocarbon Insecticides with
Special Reference to Aldrin and Dieldrin. (Unpublished
study received Mar 3, 1955 Under PP0007; prepared by
Univ. of Cincinnati, Dept. of Preventive Medicine and
Industrial Health, Kettering Laboratory, submitted by
Shell Chemical Corp., New York, N.Y.; CDL:090079-J)
00083074 Treon, J.F.: Boyd, J.; Berryman, G.; et al. (1954)
Final Report on the Reproductive Capacity of Three
Generations of Rats Being Fed on Diets Containing
Aldrin, Dieldrin or DDT. (Unpublished study received
Mar 3, 1955 under PP0007; prepared by Univ. of
Cincinatti, Dept. of Preventive Medicine and
Industrial Health, Kettering Laboratory, submitted
by Shell Chemical Corp., New York, N.Y.; CDL:090080-R)
109
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Aldrin Standard
00085416 Borgmann, A.R.; Kitselman, C.H.: Dahm, P.A.; et al.
(1952) Toxicological Studies of Aldrin on Small
Laboratory Animals. (Unpublished study received
March 3, 1955 under PP0007; prepared by Kansas State
College, Agricultural Experiment Station, Depts. of
Entomology and Pathology and Univ. ot* Cincinatti,
Dept. of Pathology, Kettering Laboratory of Applied
Physiology, submitted by Shell Chemical Corp.,
New York, N.Y.; CDL:090087-B)
00103597 Lichtenstein, E. (1958) Movement of insecticides in
soils under leaching and non-leaching conditions.
Journal of Economic Entomology 51 (Jun):380-383 .
(Also in unpublished submission received Oct 1, 1971
under 1F1070; submitted by Shell Chemical Co.,
Washington, DC; CDL:091958-AK)
00103661 Lichtenstein, E.; Schulz, K.; Skrentny, R.; et al.
(1966) Toxicity and fate of insecticide residues
in water: Insecticide residues in water after direct
applications or by leaching ot agricultural soil.
Arch Environ Health 12(Feb):199-212. (Also in
unpublished submission received Dec. 20, 1968 under
9F0785; submitted by Shell Chemical Co., Washington,
DC; CDL:091349-T)
00103736 Treon, J.; Dutra, F. ; Shaffer, F.; et al. (1951)
The Toxicity of Aldrin, Dieldrin and DDR when Fed to
Rats over the Period of Six Months. (Unpublished
study received Dec 3, 1951 under unknown adin. no.;
prepared by Univ. of Cincinatti, Dept. of Preventive
Medicine and Industrial Health, Kettering Laboratory,
submitted by Shell Chemical Co., Washington, DC;
CDL:106797-A)
00105470 Keplinger, M.: Deichmann, W.: F. Sala. (1970) Effects
of combinations of pesticides on reproduction in mice.
Pesticides Symposia (August) 125-138.
00109564 Probst GS, McMahon RE, Hill LW, Thompson DZ,
Epp JK, Neal SB. 1981. Chemically-induced
unscheduled DNA synthesis in primary rat hepatocyte
cultures: a comparison with bacterial mutagenicity
using 218 chemicals. Environ. Mutagenesis 3:11-32.
110
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Aldrin Standard
00111910 Tucker, R; Crabtree, D. (1970) Handbook of
Toxicity of Pesticides to Wildlife. Resource
Publication No. 84, Bureau of Sport Fisheries
and Wildlife, Denver Wildlife Research Center.
Denver, CO.
00123771 Epstein, S.; Arnold, E.; Andrea, J; Bass, W.;
Bisphop, Y. 1972. Detection of Chemical Mutagens
by the Dominant Lethal Assay in the Mouse.
Toxicol. and Appl. Pharmacol. 23 (288):288-325.
00151668 Ludwig, G.; Weis, J,; Korte, F. (1964) Excretion
and Distribution of Aldrin~14C and its Metabolites
After Oral Administration for a Long Period of
Time. Life Sciences 3:123-130.
00151872 Deichmann, W.; Keplinger, M. Dressier, I.; et al.
(1969) Retention of dieldrin and DDT in the tissues
of dogs fed aldrin and DDT individually and as a
mixture. Toxicology and Applied Pharmacology 14:205-213
00151879 Deichmann, W.; MacDonald, W.; Cubit, D. (1975)
Dieldrin and DDT in the Tissues of Mice Fed Aldrin
and DDT for Seven Generations. Arch. Toxicol.
34:173-182.
Ill
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration under the Aldrin Standard
GS0172-001
GS0172-002
GS0172-003
Page, N.; Cavender, F.; Cook, B. (1985)
Carcinogenic Risk Assessment for Aldrin
and Dieldrin. Unpublished study prepared by
Dynamac Corp. under EPA Contract No. 68-02-4131.
Environmental Protection Agency. Lauber, M. 1986.
Lab Recommendation for Retrospective Studies Concerning
Surface Water Contamination as a Result of Termiticide
Use of Chlorinated Cyclodienes. Memo to Michael
Firestone dated June 10, 1986.
Environmental Protection Agency. Mauer, I. 1986.
Aldrin/Dieldrin Mutagenicity. Memo to Henry Spencer
dated 6-25-86.
112
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V. FORMS APPENDICES
113
-------
OMB Approval No. 20KHH68 (Expires 12-31-83)
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by tlu FIFRA section 3(C)(2)(B) notice contained in the rtjfuence.1
Guidance Document, I am responding in the following manner
D 1. I wHI submit data in a timely manner to satisfy the folio
tquirementt. If the test procedure! I will we deviate from (or are nut
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group. OECO
Chemicals Testing Programme, I enclose the protocolt that I will user
Attach separate page with a list of the data requirements your company
agrees to satisfy.
D 2. I have entered into an agreement with one or man other reentrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any reouved protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
Attach list of data requirements
D1 I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements!
D 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
Ds.
i of the raublislkM of this product. (This option is not available to opplnnts for new productsJ
REGISTRANTS AUTHORIZED REPRESENTATIVE
EPA Fona 8SBO-1 (10-82)
SIGNATURE
DATE
114
-------
OMB Approval No. 20004)468 (Expires: 12-31-83)
(To Qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by en arbitration decision under FIFRA Section 3(c)(2)(B)dii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the fallowing dated):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accented my offer
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s). if any of the firms named in paragraph (3) above
have agreed to submit (he data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my tirm -mist submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
EPA Form BSBO-6 11042)
SIGNATURE
DATE
115
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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
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assigned
116
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing HRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assigned
•
117
-------
FORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Name
Applicant's Name and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s):
(2) Each active ingredient listed in paraqraph (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 Prom another
producer.
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
name, the source of the active ingredient(s) listed in paragraph (1).
(B) The Confidential Statement of Formula dated _ on file with
the EPA is complete, current and accurate and contains the information
required on the current CSF Form No. 8570-4. The registered source(s)
of the active ingredient(s) listed in paragraph (1) is/are listed below:
Active ingredient Source t Product name and Reg. No.
Signature
Oate Title
EPA Form (April 1985)
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