GUIDANCE FOR THE
REREGISTRATION OP WOOD PRESERVATIVE
PESTICIDE PRODUCTS
CONTAINING
CHROMATED AND NON-CHROMATED ARSENICALS
AS THE ACTIVE INGREDIENT
CASE NUMBER 064?
[CAS (DOCKET) NUMBER OF INGREDIENT OR PRINCIPAL INGREDIENT]
September 10, 1986
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OP CONTENTS
I. Introduction
II. Chemicals Covered by this Standard
A. Description of Chemical
B. Use Profile
C. Regulatory History
III. Agency Assessment ................. 7
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
IV. Regulatory Position and Rationale .......... 29
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard
VI. Requirement for Submission of Generic Data ..... kH
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
P. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data 1*9
VIII. Requirement for Submission of Revised Labeling ... 50
IX. Instructions for Submission ............. 51
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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t " APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES
Summary of label requirements and table
40 CPR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
Consumer Information Sheet
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Formulator's Exemption Statement
ii
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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 PIFRA. The standards
are applicable to reregistratlon 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 PIPRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crop*; 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 FIPRA. 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
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.
•"•The scientific reviews may be purchased from the National
Technical Information Service, 5285 Port Royal Road, Springfield
Virginia 22161 approximately 90 days after issuance and are
available from the Registration Division Product Manager
prior to that time.
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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 - Rtgulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with PIPRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CPR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA hasrauthority under the Data Call-In (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data t'o 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. CHEMICALS COVERED BY THIS STANDARD
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A. Description of chemicals
This registration standard covers the active ingredients,
containing arsenic and chromium in products intended for use as
wood preservatives. The six arsenic compounds used in the form-
ulation of wood preservatives are arsenic pentoxide, arsenic
trioxide, arsenic acid, ammonium arsenate, sodium arsenate, and
sodium pyroarsenate. All but two of these compounds, arsenic
trioxide and ammonium arsenate, are complexed with chromium when
formulated into end-use wood preservative products. The four
chromium compounds used in the formulation of wood preservatives
are chromic acid, sodium chromate, sodium dichromate, and
potassium dichromate.
For both arsenic and chromium, multiple valences exist.
The majority of arsenic is present in the pentavalent state
(arsenate, +5), although some trivalent (arsenlte, +3)
arsenic has been found. Chromium is usually present in
the hexavalent state (chromate, +6), but is also found in
the trivalent state (chromite, +3).
The general formulations of the products covered by this
standard can be described as [X]CrAs or [X]As. [X] is usually
an ionic form of copper, pentachlorophenate, 2,4-dinltrophenol,
or ammonia. Varying formulations exist within each group.
The major use group is copper chromated arsenates. There are
three basic formulas within this group. The original formulation
is now referred to as CCA-type A (chromium/arsenic ratio
of 2.73), the use of which is limited today. Updated versions,
CCA-B and CCA-C (chromium/arsenic ratios of . 5*J and .96
respectively), are now available and were designed to be even
more tightly retained by the wood that is treated, than the
original formulation.
Arsenic and chromium are commodity chemicals with many non-
pesticidal uses, and the active ingredients incorporated
into the formulated products are not always registered as
manufacturing use products.
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CHROMIUM USED IN WOOD PRESERVATIVE FORMULATIONS
Compound
Chromic acid
Sodium chromate
Sodium dichromate
Potassium dichromate
Empirical
Formula
b/
CrO?
£/
Na2Cr20y
^2^*'2^7
Molecular
Weight
100.01
161.97
261.96
294.21
a/
~ CAS
Registry
Number
07738-94-5
07775-11-3
10588-01-9
07778-50-9
Shaugh-
nessy
Number
021101
068303
068304
068302
a/ Values are for the anhydrous form.
b/ Actually, the true chromic acid (^CrOjj) exists in solution.
c/ Most likely would exist as the decahydrate (Na2CrOij. 10H20) in
solution.
d/ Would probably exist as the dihydrate (Na2CrOij. 2H20) in
solution.
ARSENICALS USED
Compound
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Ammoriium arsenate
Sodium arsenate Na
Sodium pyroarsenate
IN WOOD PRESERVATIVE
Empirical
Formula
H3AS01,
AS205
AS203
(NH|,)2HABOi,
3AsOij.l2H20
Na,A3207
Molecular
Weight
141.94
229.84
197.8
175.92
423.9
353.8
FORMULATIONS
CAS
Registry
Number
7778-39-4
1303-28-2
1327-53-3
53404-17-4
10048-95-0
13464-12-1
Shaugh-
nessy
Number
006801
006802
007001
013601
013505
013401
B. Use Profile
Type of Pesticide: Wood Preservative
Pests Controlled: Fungi, Insects, Bacteria, and Marine Borers
Registered Uses: Wood Preservative/Commercial Application
Methods of Application: Pressure Treatment and Brush on
Application (Cut Wood Ends/Construction Sites Only)
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Formulation Types Registered:
Registered "Technicals: 90%, 94%, 95-5%, 99% Arsenic trioxide
98% Ammonium arsenate
98.88/6 Sodium arsenate
End Use:
Soluble Concentrate/Liquid (SC/L) 3%-75%
Soluble Concentrate/Solid (SC/S) 4.835-23.9*
Granular (G) 1.5%
Impregnated Materials (IM) .46%
Liquid-Ready-To-Use (L/RTU) 1.518-21.2%
Wettable Powder (WP) 20%
Physical Characteristics: The Agency is requiring
information on the source and description of arsenic, chromium,
and other active ingredients in the formulated end-use products
to determine the characteristics of each product.
C. Regulatory History
The Environmental Protection Agency issued a Notice of
Rebuttable Presumption Against, Registration (hereafter
referred to as Special Review) for the wood preservative
uses of the inorganic arsenicals on October 18, 1978 (43 PR
48267). That notice was based on a determination that the
use of the inorganic arsenical pesticide products met or
exceeded the risk criteria for oncogenicity, mutagenicity,
and teratogenicity under 40 CPR 162.11, now found at
40 CPR 154.7.
In January 1981, the Agency issued a preliminary
regulatory determination (46 PR 13020) which proposed changes
to the terms'and conditions of registration for inorganic
arsenicals intended for use as wood preservatives. That
proposal was based on a detailed assessment of the risks
and benefits of continued registration (PD 2/3); the Agency
concluded that the benefits of use were high and that measures
short of cancellation could be implemented to reduce the
risks to an acceptable level. The final determination was
published in the FEDERAL REGISTER of July 13, 1984 (49 PR
28666). The Agency received hearing requests from registrants
contesting the requirements of the July 13, 1984 final
determination. After considering certain alternative
mechanisms suggested by registrants for accomplishing the
goals set out in the July 13 determination, the Agency published
in the FEDERAL REGISTER of January 10, 1986 (51 PR 1334) an
amended notice. The changes made to the requirements of the
original notice were minor in scope.
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While the Special Review only addressed the inorganic
arsenic component of arsenical wood preservative products,
this standard addresses chromium in addition to inorganic
arsenic because chromium is often complexed with arsenic
in formulated wood preservative products.
Both arsenic and chromium have been extensively reviewed
by EPA's Office of Health and Environmental Assessment (OHEA),
Office of Research and Development. The following final
reports prepared by OHEA are the main source documents for
the science assessment contained In this document:
Health Assessment Document for Inorganic Arsenic. Final
Report. EPA-bOO/8-B3-021F. Office of Health and
Environmental Assessment, U.S.E.P.A., Washington, D.C.
March 1984.
Health Assessment Document for Chromium. Final Report.
EPA-600/8-83-014F. Office of Health and Environmental
Assessment, U.S.E.P.A., Washington, D.C. August 1984.
\
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III. AGENCY ASSESSMENT
A. SUMMARY
' \
The Agency has conducted a thorough review of the scientific
data base for the inorganic salts of chromium and arsenic.
The results of this review are summarized below and discussed
in greater detail in Section III.B. of this document and
in the support documents mentioned above.
1. Inorganic arsenic and hexavalent chromium compounds
are classified as Group A carcinogens (evidence of human
carcinogenicity). There is currently sufficient evidence
from epidemiologic studies to support an association between
exposure to both chemicals and cancer. No further
oncogenicity studies will be required.
a. Inorganic arsenic compounds are both lung
and skin carcinogens in humans.
(1). Studies among smelter workers and
among workers engaged in the production and
use of arsenical pesticides have demonstrated
excess mortality due to lung cancer.
(2). A study of a non-occupational
population within Taiwan exposed to high
concentrations of arsenic in well water has
demonstrated excess occurrences of skin cancer.
The Agency is currently reevaluating the risk model
for oral and dermal exposure to inorganic arsenicals.
b. Hexavalent chromium is a lung carcinogen
in humans. Exposed workers in chromate refining
plants showed significantly increased levels of
respiratory carcinomas.
. 2. Both arsenic and chromium have demonstrated the
potential to cause teratogenic/fetotoxic effects.
a. Studies in which arsenate and chromium
compounds were administered intravenously or
intraperitoneally to hamsters, rats, and mice,
demonstrated gross malformations (terata) and
fetotoxic effects; however, the routes of exposure
were not appropriate for human risk assessment.
b. Oral studies for arsenic in mice are
deficient because they either failed to produce
gross malformations in offspring or have produced
only a slightly increased incidence of gross
malformations and only at dosage levels that have also
caused significant maternal mortality. Therefore,
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no-observable-effeet-levels (NOELs) for maternal toxicity
and teratogenic/fetotoxic effects could not be determined
from these studies.
c. Oral studies for chromium are not available.
In order to better define teratogenic or fetotoxic effects
for arsenic which may occur below maternally toxic levels, the
Agency has required two oral teratology studies; one with rabbits,
the other with hamsters or mice, using sodium arsenate or arsenic
pentoxide (See Special Data Call-in Notice on Wood Preservatives
Containing Inorganic Arsenicals, April 7, 1986). Further, the
Agency is requiring oral studies to determine teratogenic and
fetotoxic potential of chromium using a formulated chromated
arsenical product. (See Data Appendix for due dates of these
studies).
3. Due to the Agencys concern about teratogenic/fetotoxic
effects of both chromium and arsenic, the Agency is requiring
a reproduction study using a formulated chromated arsenical
product unless a metabolism study demonstrates that blood levels
of chromium and arsenic are not increased above background levels.
M. The Agency does not have adequate data to determine the
bioavailability of chromium and arsenic after exposure to a
formulated product. Metabolism data are required to assess
the bioavailability of these chemicals.
5. Short term assays indicate that hexavalent chromium
and trivalent and pentavalent arsenic are mutagenic. No
mutagenicity data are being required.
In addition to the studies noted above, the Agency has
identified ecological effects and environmental fate data
which are needed to evaluate the environmental and human risks
associated with the use of chromated and non-chromated
arsenicals. These data must be developed in order to maintain
registrations of products or register new products containing
chromated and non-chromated arsenicals. The table in this
section summarizes all the data gaps, in addition to product
chemistry information. Please note that this is only a
summary and more details can be obtained by referring to
Tables A, B, and C, Section D of Part II.
Further, the Agency has determined that labeling revisions
or restrictions in the following areas are necessary:
0 classification of all uses as restricted, except for
the commercial brush on use.
0 protective clothing and equipment requirements.
0 prohibitions against eating, drinking, or smoking
during application.
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requirements for proper care and disposal of
work clothing and equipment
requirements for proper disposal of pesticide waste.
requirements for using respirators in arsenic pressure
treatment plants when arsenic ambient air levels are
unknown or exceed 10ug/m3 over an 8 hour period
(Permissible Exposure Limit Moonitoring Program).
adherence to industry standards to reduce surface
residues of arsenic on treated wood.
using closed systems for mixing and emptying powdered
formulations of inorganic arsenicals.
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SUMMARY OP DATA GAPS FOR WOOD PRESERVATIVE PESTICIDE PRODUCTS CONTAINING
CHROMATED AND NON-CHROMATED ARSENICALS
([X]CrAs and[X]As)
DATA REQUIREMENT
I
ENVIRONMENTAL PATE
SPECIAL STUDIES - Aqueous, soil and air
availability
Aerobic Soil
Anaerobic Aquatic
Aerobic Aquatic
Volatility
TOXICOLOGY
Acute Oral
Acute Dermal
Acute Inhalation
Eye Irritation
Dermal Irritation
Dermal Sensitlzation
Teratology
Reproduction
General Metabolism
WILDLIFE AND AQUATIC ORGANISMS *«*
Avian Oral
Avian Dietary
Freshwater Fish
Freshwater Aquatic Invertebrate
Estuarine and Marine Organism LC50
Fish Early Life-Cycle and Invertebrate
Life-Cycle
PRODUCT CHEMISTRY
Product Identity and Composition
Analyls and Certification of Product
Ingredients
Physical and Chemical
Characteristics
REMARKS »
[Cr] & [As]
applied end use products *«
[As]
n
ft
[As], [Cr], & [X]
All MPs & EPs
tt tt it ti
tt n n n
it it it n
n it it tt
n ti it tt
Sodium arsenate or
arsenic pentoxide and
Formulated chromated arsenical
Formulated chromated arsenical
Formulated chromated arsenical
Formulated chromated arsenical
n ti n
ti
n
it
tt
Technicals, MPs, EPs, &
n it it
Technicals
* Indicates test material
»* Tests must determine the availability of Cr & As from
treated wood after application of a formulated chromated arsenical product.
*** Additional chronic aquatic testing reserved pending review
of required acute, subchronic and availability studies
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B. PRELIMINARY RISK ASSESSMENT FOR INORGANIC ARSENIC AND CHROMIUM
t
1. INORGANIC ARSENIC
a. Risks
There is an extensive body of information available
on the salts and oxides of arsenic from literature and
other sources. Therefore, although the Agency does not
have specific studies on the individual inorganic arsenical
wood preservative chemicals, it is not requiring additional
data under FIFRA, in many cases. This risk assessment
relies primarily on the OHEA document on inorganic
arsenic referred to previously. This and other
documents mentioned are cited in the Bibliography
(Appendix IV).
(1). Metabolism
Arsenic exists primarily in two different
valence states, pentavalent (arsenate, +5) and
trivalent (arsenite, +3). Of the two, the trivalent
state is more acutely toxic. Recent analytical
techniques which permit the chemical speciation of
arsenic into its various forms have elucidated the
metabolism of arsenic in the animal body. Two
processes, oxidation-reduction and methylatlon,
have been indicated as the mechanisms involved.
These two processes may occur sequentially or
methylation may be the sole mechanism. These two
processes are summarized below:
(a). An in-vivo oxidation-reduction
interconversion of pentavalent and trivalent
inorganic arsenic, with the trivalent form
predominating.
(b). An in-vivo methylation of inorganic
arsenic resulting in the formation of monomethyl
and dimethyl organic arsenic compounds which
are subsequently excreted.
Administration of either pentavalent or trivalent
arsenic to experimental animals or humans results
in the formation of methylated inorganic trivalent
arsenic. The iri vivo methylation process has been
observed in every mammalian system studied to date
(except in the Marmoset monkey) and is believed to
be a detoxification mechanism. In man about 75%
of the total excreted arsenic is in the form of
dimethyl arsenic.
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Retention of arsenic in skin, hair, and nails
is regarded as an excretory mechanism into a
physiologically inactive compartment. Generally,
arsenic does not accumulate in physiologically active
compartments of the mammalian body. Rats, however,
bind arsenic to erythrocytes which results is delayed
distribution to the tissues. The biological half-life
of arsenic in rats is up to 90 days as compared to
a biological half-life of several days in other
mammalian species. For this reason, the rat is not
an appropriate test species to determine potential
effects of arsenic in other mammalian species,
especially humans.
The major excretory route of arsenic in animals
and humans is via the urine. Renal clearance is
very rapid.
(2). Oncogenicity
The Agency has performed an assessment of the
weight-of-evidence for carcinogenicity of Inorganic
arsenicals. Based on epideraiological studies in
humans and on other supportive studies and Infor-
mation, it was concluded there is sufficient evidence
that Inorganic compounds of arsenic are both lung
and skin carcinogens in humans. According to the
Agency's draft Guidelines for Carcinogen Risk
Assessment (January 7, 1986) inorganic arsenicals
have been classified in Group A (carcinogenic
to humans).
A large number of toxicological studies are
available on the oncogenicity of arsenic compounds.
The most critical and persuasive evidence linking
human cancer with exposure to inorganic arsenicals
was derived from epidemiology studies. An excess
mortality due to lung cancer from exposure to
arsenic was demonstrated in several studies of
smelter workers and among workers engaged in the
production of arsenical pesticides. The increased
mortality In these studies was related to occupa-
tional inhalation exposure to inorganic arsenicals.
A final risk model for occupational Inhalation
exposure was based on three studies of copper
smelter workers and on an NCI series of statistical
analyses of some of these same workers:
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(a). Higgins, e_t a_l. (1982) conducted a followup
study on smelter workers in Anaconda, Montana, who
had previously been studied by Lee and Fraumeni in
1969. The Higgins study contains data on 1800 men,
including all of the heavy exposure workers and 20%
of the other workers from the Lee and Fraumeni study.
Cumulative exposures were estimated and information
on smoking habits was obtained for most of the cohorts.
A statistically significant increase in the number
of respiratory cancers was observed among non-
smokers in the high exposure group. This study
is summarized in the OHEA report, pp. 7-104 to 7-110.
b. Lee-Feldstein (1983) surveyed 8047 smelter
workers at the same location as Higgins et al. in
Anaconda, Montana. This large study followed
mortality for up to 39 years among workers who had
been employed for at least 12 months. Workers were
categorized into heavy, medium, and light exposure
groups and by length of employment. Detailed
work exposure levels and work histories were
available. At all exposure levels, there
was a statistically significant number of excess
respiratory cancers. This study is summarized
in the OHEA report, pp 7-95 to 7-104.
c. Enterline and Marsh (1982) studied 2802
men who had worked at a Tacoma, Washington, smelter
for a year or more between 1940 and 1964, with
observations through 1976. Individual exposures to
airborne arsenic were estimated using work histories
and were correlated to levels of arsenic found in
urinre. A statistically significant increase in
respiratory cancers was observed at the higher
exposure levels studied. This study is summarized
in the OHEA report, pp. 7-118 to 7-128.
d. Brown and Chu (1983 a, b, c) applied a
multi-stage theory of carcinogenesis to the
Anaconda smelter studies of Lee-Feldstein, taking
into account exposure rate, durations of exposure,
age at initial exposure, and time since cessation
of exposure. Brown and Chu's analysis is described
in the OHEA report, pp. 7-110 to 7-118.
The CAG used the epidemiological studies of
Higgins, Lee-Feldstein, and Enterline and Marsh
and the statistical analysis of Brown and Chu in
developing its final unit risk estimate for
inhalation oncogenic risk, as described in the OHEA
report, pp. 7-130 to 7-135.
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Other human epidemiology studies have demonstrated
an association between skin cancer in non-occupational
populations and high levels of arsenic in drinking
watefr. Persons exposed to arsenicals in medicines
have also been shown to be at risk. The Agency has
prepared a risk model for oral exosure to inorganic
arsenicals based on an epidemiology study of skin
cancer in a section of Taiwan with high arsenic
concentrations in well water (Tseng et al., 1968).
The Agency's Risk Assessment Forum, an Agency-
wide task group charged with assessing risk issues,
is currently reevaluating this risk model for
exposure via the dermal and oral routes. Their
report is expected to be Issued in late 1986 or
early 1987.
In contrast to the clear association between
inorganic arsenicals and cancer in humans, arsenic
carcinogeniclty in test animals has not been observed
in most studies. A few recent reports have noted
positive results. Studies in species other than
rats have generally shown negative findings. The
OHEA document (pp. 7-77 to 7-87) summarizes 32
studies using animals, in which the majority of
studies (25) were either negative or inconclusive.
Given the extensive amount of information on human
exposures, the Agency is not requiring additional
oncogenicity animal studies.
(3). Mutagenlclty
Providing support to the carcinogenic finding
are results from numerous mutagenic and other
gentoxic assays. The weight of evidence indicates
that arsenate and arsenite can interact with DNA
in: mammalian somatic and gonadal cells and there-
fore may have the potential to cause heritable
effects in humans.
Observed positive effects in various assays
have included chromosome-breaking effects, inter-
ference with DNA repair mechanisms, direct toxlclty
to mammalian gonads, and positive effects in selected
microbial test systems for mutagenicity.
The Agency concludes from the available data,
that inorganic arsenicals, administered in either
the pentavalent or trivalent form, may Induce
chromosomal aberrations in vitro. This effect has
been shown in human fibroblast cells, Syrian hamster
embryo cells, and human peripheral lymphocytes.
Results for some studies are dose-related, and
arsenites are more potent than arsenates in the
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induction of chromosomal aberrations in cultured
mammalian cells. In addition, among lymphocytes
cultured from exposed workers (or from patients
undergoing treatment with medicinal arsenicals)
ther% is suggestive evidence of chromosomal damage
by arsenic in vivo. Furthermore, inorganic arsenic
may potentiate the effects of chromosome-damaging
agents (Sram, 1976; T.C. .Lee, et al., 1986).
A dominant lethal test conducted by Sram and
Bencko (197*0, indicated that inorganic arsenic
reached the germ cells (gonads) and produced mutagenic
effects in mammals. Further, studies by Petres et al.
(1970, 1977) suggest that human exposure to arsenic
can cause chromosomal aberrations and aneuploidy
in humans in vivo.
(4). Teratogenicity/Fetotoxicity
The potential of inorganic arsenic to produce
teratogenic effects through parenteral exposure is
established.
(a). Parenteral administration of sodium
arsenate (+5) or sodium arsenite (+3) to
experimental animals during pregnancy has
produced gross malformations (terata) in the
offspring. Increased mortality, increased
resorptions, and decreased body weights of
fetuses have also been observed in these studies.
(b). In contrast, oral (gavage) adminis-
tration of sodium arsenate or arsenite to
experimental animals has either failed to
produce gross malformations in offspring or
has produced only a slightly increased incidence
and only at dosage levels that have also
: caused significant maternal mortality.
NOELs could not be established for these
studies. Oral administration of sodium arsenite
to experimental animals yielded almost identical
results to those for sodium arsenate although
at somewhat lower dosage levels.
Intravenous and intraperitoneal administration
are not typical of the exposure likely from pesticide
use. The available oral studies do not fulfill
Agency requirements, and do not demonstrate conclusively
that inorganic arsenicals are teratogenic or fetotoxic
by the oral route of exposure (except at levels
also showing maternal effects). Therefore, the
Agency is currently unable to assess the risks of
teratogenicity/fetotoxicity likely from pesticide
-15-
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use of chromated and non-chromated arsenicals.
Additional studies have been required to assess
teratbgenic risks. (See Special Data Call-In Notice
on Wood Preservatives Containing inroganlc Arsenicals,
April 7, 1986).
(c). Arsenic can cross the placental
barrier and has been incriminated In neonatal
deaths (Gosselin et al, 198*0. Human epidem-
iological studies have implicated arsenic as a
teratogen. Increased spontaneous abortions
and decreased mean birthweights of offspring
were reported among female workers employed in
a smelter in Sweden. These women were exposed
not only to arsenic, however, but also to a
variety of diverse chemicals in the smelter
(OHEA, 1984).
(5). Reproductive effects
There are insufficient data to assess the
effects of inorganic arsenicals upon reproductive
functions. In light of the Agency's concern about
possible teratogenic/fetotoxic effects of
arsenicals, a reproduction study is required.
(6). Acute toxiclty
The acute oral toxiclty of inorganic arsenicals
In humans has been well documented over centuries
of use as a poison in homicides, suicides, and from
accidental ingestion of drugs and pesticides. The
pentavalent forms are less toxic than the trivalent
ones; however, both forms are classified as Toxicity
Category I (the Agency's highest acute toxiclty
category) and the symptoms of toxicity are the
same. The reported oral toxicity of arsenic acid
in rats is 48-100 mg/kg, however, the rat is a
poor model for toxicity in man, since it binds
arsenic in the body. Man appears to be more sensitive
to arsenic poisoning on a dose per weight basis
than the rat. Acute oral, dermal, and inhalation
toxicity data are required. In addition eye and
dermal irritation and dermal sensitization are
required. All acute studies must be conducted on
each manufacturing use product and end-use product.
(7). Neurotoxicity
Arsenic is known to cause neurotoxic effects
in humans. The expression of severity of effects
dependent upon the type and duration of exposure.
Acute and subchronic exposures typically lead to
peripheral neuropathy, distal muscle weakness and
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loss of sensation, which may progress to paralysis
and crippling. Lower exposures and chronic exposures
generally have a more gradual onset of similar
symptoms.
(8). Other observed effects in humans
Other chronic and subchronic effects of
inorganic arsenicals that have been observed in humans
include:
0 Skin toxicity, resulting in hyperplgmentation
and disorders such as eczema, redness,
keratosis, loss of nails, and swelling, which
are reversible if exposure ceases.
0 Toxicity to the blood system, resulting in
blood dyscrasias of various forms, also is
reversible if exposure ceases.
0 Liver and kidney toxicity, with Jaundice,
degeneration of the tissues, and cirrhosis.
0 Pulmonary system effects, perforation of the
nasal septum, and tracheal and bronchial effects,
(9). Risks
The following risk estimates were extracted from
the OHEA report on inorganic arsenic.
(a). The inhalation oncogenic risk of arsenic
was based on epidemiological studies of copper
smelter workers (Higgins et al., Lee-Feldstein,
Enterline and Marsh, and three series of analyses
: by Brown and Chu). The final risk was estimated
to be 4.1 X 10~3 for workers in pressure treatment
plants based on an assumed exposure of 10 ug/m3
inorganic arsenic levels in the air averaged over
an 8 hour workday.
(b). The potential risks of skin cancer from
dermal and oral (gastro-intestlnal) exposure to
arsenic were estimated using a risk equation based
on the epidemiological study of skin cancer in
more than 40,000 people in a section of Taiwan
with high concentrations of arsenic in the well
water (Tseng et al.). The Agency Risk Assessment
Forum is currently reevaluating this risk model
to be used for exposure via the oral and dermal
routes. Their report is expected to be issued in
late 1986 or early 198?.
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However, based on this risk model the dermal risk
estimates were:
i
i. 2.8 X 10~3 for brush on applications
of arsenic,
ii. 6.2 X 10-3 for handling freshly
treated wood and mixing dilute formulations, and
ill. 7.3 X 10~3 for bag emptying.
The oral (gastrointestinal) risk from sawing/
fabricating treated wood was estimated to be:
i. 3.1 X 10"^ (copper chromated
arsenate) and
ii. 7.6 X 10"** (ammoniacal chromated
arsenate).
Regulatory measures (respirators, protective clothing,
closed systems) required as part of the Special Review
will reduce risks to the orders of 10"^ to 10"5.
This level of risk does not outweigh the benefits of
continued registration of these products.
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2. CHROMIUM
a. ftisks
The toxiclty of chromium has been discussed in
detail in the Health Assessment Document for Chromium.
This document includes a risk assessment for the
carcinogeniclty of chromium compounds and is the sole
reference for the following discussion of chromium.
(1). Essentiality of Chromium and its
Metabolism
Chromium exists in several valence states.
Only the trivalent and hexavalent forms of
chromium are biologically significant.
Trivalent chromium is an essential element
in animals including humans. It plays a role in
glucose and llpid metabolism. Chromium supplemen-
tation improves or normalizes glucose tolerance in
diabetics, older people, and malnourished children.
It has been suggested that chromium deficiency may
be a basic factor in atherosclerosis. A deficiency
of trivalent chromium apparently increases the
toxicity of lead.
Although the exact level of chromium needed
for good health is unknown, it is assumed that an
average American intake of 0.05 to 0.2 mg/day
is adequate.
Trivalent chromium transport in the blood
is facilitated by specific binding proteins.
Hexavalent chromium, on entering the blood stream,
diffuses into the blood cells where reduction
and binding to cellular components occurs. Absorbed
trivalent and hexavalent chromium can be transported
to a limited extent to the fetus In utero after
exposures of the dams, although existing data do
not allow quantitative estimations of fetal exposure,
Chromium transported by the blood is distributed to
other organs with greatest retention by the spleen,
liver, and bone marrow. The major deposition site
following Inhalation exposure is the lungs, where
chromium probably binds to the cellular material
before absorption can occur.
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Absorbed chromium is rapidly cleared from the
blood while clearance from tissue is slower.
Urinary excretion is the primary route of elimination
accounting for somewhat over 50% of the eliminated
chromium. Fecal excretion accounts for only 5% of
the elimination from the blood. The remaining
chromium is deposited into deep body compartments.
Limited work on modeling the absorption and deposition
of chromium indicates that adipose and muscle
tissue retains chromium at a moderate level (approxi-
mately two weeks), while the liver and spleen
store chromium for up to 12 months. Estimated
half-lives for whole body chromium elimination are
22 days and 92 days for hexavalent chromium and
trivalent chromium, respectively
(2). Oncogenicity
According to the Agency's draft Guidelines for
Carcinogen Risk Assessment (49 PR 46294), and
based on combined animal and human epldemiological
data, hexavalent chromium is classified in Group A
(carcinogenic to humans).
a. Epldemiological studies of chromate
production facilities in the United States, Great
Britain, West Germany, and Japan have all found an
association between occupational exposure to
chromium and lung cancer and are sufficient evidence
of the carcinogenlcity of chromium. Workers in
the chromate production industry are exposed
to both trivalent chromium (+3) and hexavalent
chromium (+6) compounds. Most of the epidemiologic
studies did not attempt to determine which chromium
compounds were the etiologic agents.
: The strength of the association of exposure
in the chromate production industry with lung
cancer is evidenced by the high lung cancer
mortality ratios found in various studies,
the consistency of results by different investi-
gators in different countries, the dose-response
found in several studies, and the specificity
of the tumor site, the lung. The magnitude
of the mortality ratios found in several
studies (studies of three independent cohorts of
chromate production workers found lung cancer
mortality ratios of at least 9.5 or greater) lends
strong support to the association between
exposure in the chromate production industry
with lung cancer.
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The best data that can be used for estimating
cancer risks due to exposure to chromium compounds
are found in the study by Mancuso (1975). In that
1 study, Mancuso reported age-specific lung cancer
mortality data for chromate production workers in
terms of total chromium exposure, which included
exposure to both triyalent and hexavalent
chromium compounds. Available data, discussed
below, suggest that only hexavalent chromium
compounds are carcinogenic.
b. Although Increased risk of lung cancer
has been associated with Inhalation of chromium by
workers in the chromium industry, as discussed
below, It has proven difficult to demonstrate
.a carcinogenic response in the lungs of experimental
animals.
Trivalent chromium compounds have not produced
lung tumors after inhalation (in mice or rats),
intratracheal implantation (in mice), or intra-
pleural Implantation (In mice). Hexavalent
chromium was not carcinogenic by inhalation
(In mice or rats) or intratracheal instillation
(in mice or rats). Some hexavalent chromium
compounds did produce tumors following intra-
bronchial or Intrapleural implantation (in
rats); however, the number of animals (14)
was small in the study of calcium chromate
(Hueper and Payne, 1962). Furthermore, the report
of Hueper (1961), where a number of hexavalent
chromium compounds were reported to be carcinogenic,
lacked detailed Information. The combination of
problems with these two studies make it difficult
to evaluate the potential carcinogenicity of
these compounds to rodent respiratory tissue.
For these reasons, studies of respiratory
cancer In animals do not provide substantial
confirmation of lung cancer. However, the
limited data suggest that of the two valences,
hexavalent chromium Is more likely to be the
etiologic agent in chromium-induced cancer.
Hexavalent chromium has produced implant-
ation site tumors in rats following intramuscular
implantation, while trivalent and metallic
chromium compounds have not. The relevance
of studies using intramuscular implantation
to human risks following inhalation or oral
exposure to chromium compounds is not clear;
however, these animal studies again indicate
that some hexavalent chromium compounds are
likely to be the etiologic agent in human
chromium-related cancer.
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Trivalent chromium has been tested for
carcinogenicity by the oral route in rats and
mice with no significant increase, in tumors
in treated animals as compared with controls.
These studies have not been reported in detail.
No additional oncogenicity data are required.
3. Mutagenicity
The valence state of chromium is an important factor in
producing a mutagenic response in the Ames assay. Only
hexavalent chromium has consistently demonstrated positive
mutagenic activity in Salmonella typhimurium in the absence
of metabolic activation. After metabolic activation, however,
the chromium shows only marginal, if any, mutagenic activity.
This suggests that the mammalian enzymes or cofactors in
the activation system reduced hexavalent chromium to trlvalent
chromium. Although these studies show that hexavalent
chromium compounds produce a positive response, they do not
indicate whether hexavalent or trivalent chromium is the
ultimate mutagen which interacts with the DNA of the cell.
Both trivalent chromium and hexavalent chromium have
been demonstrated to Interact with DNA in bacterial assays,
and hexavalent chromium has inhibited DNA synthesis and
increased unscheduled DNA synthesis in mammalian cells
in culture.
In in vitro studies, both trivalent and hexavalent
chromium have increased the infidelity of DNA replication.
As observed with interaction with DNA, both valences of
chromium have been demonstrated to produce clastogenic
effects (chromosome breaking) in mammalian cells with
hexavalent chromium being more active than trivalent chromium.
The effects observed included a variety of chromosomal
aberrations, sister chromatid exchange, and the appearance
of micronuclei in polychromatic erythrocytes.
Increased chromosomal damage also has been observed in
human lymphocytes cultured from subjects occupationally
exposed to chromium.
For all the observed genotoxic effects, it has been
suggested that trivalent chromium may be the predominant
intracellular species as a result of the reduction of
absorbed hexavalent chromium by cellular components.
No additional mutagenicity data are required.
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l\. Teratogenicity and Reproductive effects
Chromium has adversely affected fetal development
and male reproduction in experimental animals.
i
Hamsters administered chromium trioxide intravenously
on day 8 of gestation had an Increased Incidence of cleft
palates in the young when examined on day 15 of gestation.
The malformations were strain specific and associated
with maternal toxicity.
Studies on the mouse Indicated that while some
skeletal effects were present, increased incidence of
cleft palate or fetal death were not observed. While
several of the studies reported fetal malformations
only where maternal toxicity was also present, not all
studies reported data on maternal effects, so definitive
conclusions concerning the correlation between fetal
and maternal effects cannot be made at this time.
Reproductive effects of chromium include testicular
degeneration in rabbits receiving 2 mg/kg/day for 6 weeks
of either trivalent or hexavalent chromium compounds by
intraperltoneal injection. The trivalent chromium compound
produced more severe effects in this study than did the
hexavalent chromium compound (Behari et al., 1978).
The relevance of the observed effects in both the
teratology and reproduction studies to effects observed
after environmental exposure is questionable since the
routes of exposure in these studies were not typical routes
of exposure in humans. Therefore oral teratology and
reproduction studies using a formulated chromated arsenical
product are being required.
5. Acute toxicity
a.: Trivalent chromium compounds have a very low
order of toxicity when administered orally. Oral LD5Q
values for the rat have been reported as follows:
chromic chloride, 1.87 g/kg; chromium acetate, 11.26 g/kg;
chromium nitrate, 3.25 g/kg (Smyth et al., (1969).
Kobayashi et al. (1976) have determined oral LD5Q for
chromium trioxide in mice and rats to be 135 to 177 mg/kg
and 80 to 114 mg/kg, respectively, with death occurring
between 3 to 35 hours. Symptomatology included
diarrhea, cyanosis, tail necrosis, and gastric ulcer.
Surviving animals showed Increases in liver and testes
weight without microscopic changes.
b. Hexavalent chromium is more acutely toxic than
trivalent chromium. A primary effect of acute exposures is
kidney failure. Oral administration of high doses results
in gastric corrosion. The oral LDc0 of sodium dichromate in
humans has been reported as 50 mg/Kg (NIOSH, 1979).
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c. Numerous investigators have demonstrated that
sensitizatlon of laboratory animals (guinea pigs) can be
produced t>y exposure to various chromium compounds, including
both hexavalent and trivalent chromium.
Acute oral, dermal and Inhalation toxlcity data are
required. In addition, eye and dermal Irritation and dermal
sensitizatlon data are required. All acute studies must be
conducted on each manufacturing-use product and end-use product,
6. Other observed effects in humans
Occupational exposure to chromium compounds, mainly
through Inhalation, causes dermatitis, penetrating ulcers
on hands and forearms, perforation of nasal septum, and
inflammation of the larnyx and liver. The dermatitis
is probably due to an allergic response; persons sensitive
to hexavalent chromium also respond to trivalent chromium.
The ulcers are believed to be due to chromate ion and not
metalic chromium. Chromic acid, and to a lesser extent,
chromate, are presumably the causative agents In perforation
of the nasal septum.
7. Risks
A number of epidemiologic studies have found an
association between exposure to chromium compounds and
lung cancer. The best data that can be used, however,
for estimating cancer risks due to exposure to chormium
compounds are found In the study by Mancuso (1975).
That study reported age-specific lung cancer mortality
data for chromate production workers In terms of total
chromium e/posure (i.e., exposure to both trivalent and
hexavalent chromium combined).
As: noted previously, available data suggest that
only hexavalent chromium compounds are carcinogenic.
Thus, a risk estimate based on total chromium exposure
will underestimate the risk due to hexavalent chromium
alone. In another study (Bourne and Yee, 1950), the
ratio of trivalent to hexavalent chromium in airborne
dust was determined In the plant's nine major departments.
The ratio ranged from 1 to 3 in seven of the departments;
was 6 for the lime and ash operation, and was as high
as 52 for ore preparation. Therefore, excluding ore
preparation, the maximum ratio of trivalent to hexavalent
chromium Is 6, and thus the underestimation of the risk
would not be more than sevenfold.
-------
The lifetime cancer unit risk calculated by the
Agency fttDih the Mancuso (1975) data was determined to be
1.2 x 10~2 based on a constant exposure to air containing
Iug/m3 of total chromium.
Assuming that the ratio of trivalent to hexavalent
chromium is 6:1, the Agency's risk estimate may under-
estimate the risk from hexavalent chromium by sevenfold.
However, other factors such as use of 19^9 hygiene data
to determine worker exposure and implicit assumptions
that the smoking habits of chromate workers are similar
to those of the general white male population may result
in overestimatlon of the risk by four times.
On balance, the estimate based on the Mancuso data
is Judged to be the best possible estimate of the risk
from hexavalent chromium.
It is possible to estimate potential Inhalation
exposure of wood treatment workers to chromium, based
on the ratio of chromium to arsenic in formulated
products. This ratio has been calculated to be .96 or
approximately 1:1.
If the bioavailability of chromium is similar to
that of arsenic, the risk from the use of chromium in
formulated wood preservative products will be the same
order of magnitude as the risk from the use of arsenic
in formulated wood preservative products. However, the
relative bioavailability of these two constituents,
administered together as formulated wood preservative
products, is not fully known. The Agency is requiring
data to determine the relative bioavailability.
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C. OTHER SCIENCE ASSESSMENTS
\
1. Toxiclty to fish and wildlife.
Data needed to fully assess the toxlcity of
chromated and non-chromated arsenlcals to birds.are
not available. Based on avlan dietary studies in
mallard duck and bobwhite quail, copper chromated
arsenicals can be characterized as at least slightly
toxic to avian wildlife on a subacute basis.
LC5os of greater than 4640 ppm (CCA) were reported
for both bobwhite quail and mallard duck.
The toxlcity of copper chromated arsenicals
to freshwater fish varies widely. The compound
was reported to be highly toxic to rainbow trout
(LC5Q = «84 ppra) but only slightly toxic to
bluegill sunfish (LC^Q = 90.2ppm). Chromium
LC50S for freshwater fish have been shown to
be in the range of 17 to 118 ppm. Additional
studies will have to be submitted before the Agency
can determine whether these values are reliable.
No evaluation of the acute toxicity of chromated
arsenicals to freshwater aquatic invertebrates can
be made at this time. Chromium LCcQS for Daphnla
have been reported to be approximately 0.05 ppm.
2. Endangered species
A hazard assessment to endangered species
can not be made until the aquatic availability
studies required under this standard are submitted.
These studies will indicate whether or not the
amount of [Cr], [As], and additional ions which
leach out of treated wood into the soil and water
is high enough to pose a threat to endangered
species.
3. Environmental Fate
The Agency lacks data to characterize the
environmental fate of chromium and arsenic formulated
as chromated arsenicals. The Agency is requiring
studies to determine the availability of chromium
and arsenic from treated wood to both soil and aquatic
media. Results of these studies will determine
whether additional environmental fate data will be
required.
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3. Benefits
The appllbation of wood preservative chemicals protects
wood from attack by fungi, insects, bacteria, or marine
borers. In most cases the life expectancy of treated wood is
five or more times that of untreated wood.
The following is a summary of the extensive benefits analysis
contained in the PD 4 for Wood Preservatives. Because chromium
is often an additional active ingredient of inorganic arsenical
wood preservatives the benefits from the use of chromium
approximate those of the inorganic arsenical wood preservatives
discussed below. Arsenical wood preservatives have three
major uses and several other wood uses as described below.
a. Lumber, Timber, and Plywood
In 1978 more than 70$ of the total treated lumber, timber
and plywood was treated with inorganic arsenicals. Inorganic
arsenical treated wood is clean, odorless, paintable, easy to
handle, harmless to plants and more durable than other treated
wood. Uses includ patios, decks, playground equipment,
cooling towers, greenhouses, horticultural nurseries, and
all-weather wood foundations. The two other major wood
preservatives, pentachlorophenol and creosote, have limited
uses for lumber, timber and plywood due to odor, objectionable
vapors, and oily surfaces which can not be painted.
Because of the Wide variety of uses for treated lumber,
timber, and plywood, the Agency could not quantify the
anticipated economic impact if all three wood preservatives
considered in the special review had been cancelled for
this use. Non-wood materials such as plastic, steel, or
concrete would be substituted for treated wood and would
likely cost more than wood. There would be a major adverse
economic impact if the registrations of inorganic arsenicals
were cancelled because pentachlorophenol and creosote treated
lumber, timber, and plywood are not generally acceptable
alternatives to lumber, timber, and plywood treated with
inorganic arsenicals.
b. Pence Posts
In 1978, about .25% of fence posts were treated with
inorganic arsenicals. If the inorganic arsenicals were
cancelled, the impact would be a cost increase of $4.0 to
$4.5 million annually for treated wood posts depending on
which alternative (creosote or pentachlorophenol) is chosen.
If all three wood preservatives were cancelled, steel or
concrete posts would be the most likely alternative for
fence posts. Although steel posts are priced competitively
with treated wood posts, farmers' preference for treated
wood posts indicates that they are superior to metal posts
-27-
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in terms of cost or performance (USDA, 1980, p. 325). Concrete
posts would be more expensive than steel and would not be
substituted irf most farm situations.
c. Wooden Poles
In 1978, approximately 6% of wooden poles were treated
with inorganic arsenicals. With one exception, there are no
viable chemical alternatives for the three major wood preservatives
used for treating poles. Copper naphthenate can substitute
for the three major wood preservative chemicals for treating
poles. However, due to the wood becoming brittle, the uses
of copper naphthenate treated poles Is limited. Non-wood
alternatives for treatment of poles Include the use of concrete
and steel as pole construction materials. Another alternative
(for telephone and electric poles) would be to install under-
ground distribution and transmission lines in urban areas or
in new subdivisions.
If inorganic arsenicals were cancelled for wooden poles,
there would be an additional cost of $1.9 million for the
first year and an additional cost of $17.8 to $32.8 million
for each subsequent year. If all three major wood preser-
vatives were cancelled for poles, the most likely substitutes
would be concrete and steel. Under this scenario there would
be large cost increases ranging from $1.3 to $2.1 billion
annually depending on the alternative chosen.
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IV. REGULATORY DETERMINATIONS
I
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data
and other relevant information on chromium and arsenic,
the Agency has made the following determinations:
1. The Agency will not, at this time, initiate a Special
Review [40 CPR Part 154 (previously 40 CPR 162.11)] on
the wood preservative uses of inorganic arsenlcals or
chromium.
Rationale; Inorganic arsenicals were placed in Special
Review by the Agency in October, 1978 due to suspected
oncogenlc, mutagenic, and teratogenic/fetotoxic effects.
The Special Review resulted in the Agency's determination
that Inorganic arsenicals are mutagenic. The Special
Review also resulted in the classification of Inorganic
arsenicals as Group A oncogens (See Preliminary Risk
Assessment, and the Agency's Draft Guidelines for Carcinogenic
Risk Assessment, January 7, 1986). The Agency further
determined that requirements for protective measures
and restrictions would reduce exposure and risk to
levels that are outweighed by the benefits of these
compounds. The Special Review also resulted in the
determination that teratogenicity data for inorganic
arsenic are inadequate and replacement studies were
required through a Data Call-in letter dated April 7,
1986. Once the appropriate data are received, the
Agency can reassess the potential for inorganic arsenicals
to result In teratogenic effects.
There is an established association between hexavalent
chromium and carcinogenicity in humans. Chromium has been
classified as a Group A oncogen and has also been shown
to be mutagenic in short term assays. Both the potency
of, and the exposure to chromium from wood preserving
uses, are expected to approximate those for inorganic
arsenicals and the risks from each are of the same order
of magnitude. Further, the protective measures imposed
as a result of the Special Review on workers using
inorganic arsenical wood preservatives (most of which
contain chromium) are expected to reduce exposure from
chromium as well and result in reductions in risk of the
same order of magnitude. Therefore, the Agency is not,
at this time, placing chromium into Special Review.
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2. The AgencV is maintaining the Restricted Use classification
which was imposed as a result of the Special Review.
The Restricted Use classification applies to all wood
preservative uses of chromated and non-chromated
arsenlcals except the commercial construction brush-on
use.
Rationale; Inorganic arsenicals and chromium have been
demonstrated to cause carcinogenicity in humans by the
Inhalation route of exposure. The Agency believes that, to
minimize the risks to users of chromated arsenicals, use
should be limited to persons who have been trained in proper
use procedures and exposure reduction measures.
3. The Agency is maintaining all other measures and restrictions
resulting from the Special Review as well.
Rationale; Among the other requirements imposed as a result
of the Special Review were protective clothing and
equipment requirements; the requirement to limit visible
surface residues on treated wood; the requirement for
the use of closed systems for emptying and mixing powder
formulations; and the requirement to use respirators
unless monitoring shows arsenic air levels to be below
10ug/m3 (See Section IV D, Required Labeling ). These
measures and restrictions are necessary to reduce exposure
of persons who are treating wood with Inorganic arsenicals.
4. The Agency is not, at this time, placing any regulatory
requirements or restrictions on use of the treated wood itself,
Rationale: Risk from exposure to treated wood itself is
expected to be less significant than that resulting from
exposure to the wood preservative chemicals prior to
application. This is due to the fact that the wood
preservative chemicals are bound to the wood and have only
limited availability from the wood after treatment.
Nonetheless, the wood preserving Industry has instituted
a voluntary consumer awareness program designed to
Inform users of treated wood of proper uses and handling
precautions (See Appendix II). If the Agency determines,
in the future, that risks from use of treated wood are
higher than believed, regulatory requirements or restric-
tions will be considered.
5. The Agency is requiring an air monitoring study to
determine the potential exposure to chromium under conditions
found within wood treating plants. The study must also
determine the relative chromium/arsenic ratio found in
the air samples.
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2. The Agencjy'is maintaining the Restricted Use classification
which was imposed as a result of the Special Review.
The Restricted Use classification applies to all wood
preservative uses of chromated and non-chromated
arsenicals except the commercial construction brush-on
use.
Rationale; Inorganic arsenicals and chromium have been
demonstrated to cause carcinogenicity in humans by the
inhalation route of exposure. The Agency believes that, to
minimize the risks to users of chromated arsenicals, use
. should be limited to persons who have been trained in proper
use procedures and exposure reduction measures. The Agency
decided not to require the commercial brush on uses to be
restricted to certified applicators in favor of labeling
which would require use only in commercial applications
for cut ends of pressure treated wood. The Special Review
Final determination, referred to on page 5 of this document,
provides additional details.
3. The Agency is maintaining all other measures and restrictions
resulting from the Special Review as well.
Rationale; Among the other requirements imposed as a result
of the Special Review were protective clothing and
equipment requirements; the requirement to limit visible
surface residues on treated wood; the requirement for
the use of closed systems for emptying and mixing powder
formulations; and the requirement to use respirators
unless monitoring shows arsenic air levels to be below
10ug/m3 (See Section IV D, Required Labeling ). These
measures and restrictions are necessary to reduce exposure
of persons who are treating wood with Inorganic arsenicals.
4. The Agency is not, at this time, placing any regulatory
requirements or restrictions on use of the treated wood itself,
Rationale; Risk from exposure to treated wood itself is
expected to be less significant than that resulting from
exposure to the wood preservative chemicals prior to
application. This is due to the fact that the wood
preservative chemicals are bound to the wood and have only
limited availability from the wood after treatment.
Nonetheless, as part of a settlement agreement with the
Agency, the wood preserving industry has instituted a
voluntary consumer awareness program designed to Inform
users of treated wood of proper uses and handling precautions
(See Appendix II). If the Agency determines, in the
future, that risks from use of treated wood are higher
than believed, regulatory requirements or restrictions
will be considered.
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The Agency is requiring an air monitoring study to
determine the potential exposure to chromium under conditions
found within wood treating plants. The study must also
determine the relative chromium/arsenic ratio found in
the air samples.
Rationale: Due to the oncogenic potential and other
toxicological concerns of the various component of the
chromated and non-chromated inorganic arsenicals, in-plant,
on-site measurements of the ambient airborne levels of
arsenic and chromium from treating mixtures is required.
These data will allow the Agency to determine whether the
potential exposure to chromium in wood treating plants
poses more significant concern than that previously described
in this document due to exposure to arsenic. These data
may also allow the Agency to calculate airborne chromium
levels based on the arsenic levels found from the ongoing
monitoring required as a result of the Special Review,
thus potentially alleviating the need for future chromium
monitoring.
The Agency is requiring teratology and reproduction
studies using a representative chromated arsenical
formulation unless the required metabolism study
demonstrates that blood levels of chromium and arsenic,
after exposure to the formulated product, are not increased
above background levels.
Rationale: Current information regarding the bioavaila-
bllity of chromium and arsenic after exposure to formulated
chromated arsenical wood preservatives is inadequate.
The current assumption is that chromium blood levels do
not increase beyond background levels. The metabolism
data will allow the Agency to determine whether this
assumption is correct. The metabolism, teratology, and
reproduction studies must be conducted using a test
species other than the rat since the rat is known to be
anomalous to humans with respect to metabolism of arsenic.
7. The Agency is deferring a decision regarding the
need for many of the environmental fate studies normally
required. The Agency will determine the need for these
environmental fate studies after special availability
studies (in aqueous and soil media) for end use products
are submitted and reviewed.
Rationale: There is inadequate information on the
amount of the formulated product which actually is
available to aqueous or soil media from treated wood.
Therefore, the Agency is requiring testing to determine
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the quantity, form, and valence of each component of
the chronfated and non-chromated arsenicals which is
available to these media from commercially treated wood.
If these studies indicate that the concentration of
arsenic, chromium, or the additional ions combined
together in the formulated product, is high enough
to cause concern, the Agency may require additional
environmental fate data for arsenic, chromium, or the
additional ions.
8. Chronic aquatic testing may be required depending on the
outcome of (1) acute and subchronic aquatic organism
testing, (2) aqueous and soil availability studies, and
(3) the Agency's resultant hazard assessment.
Rationale: The uses of treated wood (as pilings and in
the construction of boat docks and bridges) may allow a
continuous release of chromium and arsenic into aquatic
environments. As a result, aquatic organisms are likely
to be exposed to chromium and arsenic ions. The amount
of release over time to the aquatic environment from
these uses is not yet known. If acute, subchronic, and
availability data indicate that exposure may be significant
over extended periods of time, data may be required to
determine whether there are long term effects to aquatic
organisms.
9. The Agency cannot assess the hazard to endangered species
from use of treated wood at this time.
Rationale; In order to determine potential exposure to
endangered species, the aquatic organism data and
special availability studies discussed in regulatory
positions 7 and 8 in addition to acute avian studies
must be•submitted and reviewed. A full hazard assessment
will be conducted when these data are received.
10. In addition to the product chemistry data traditionally
required for manufacturing-use and technical products,
the Agency is requiring that the source and description
of arsenic, chromium, and other active ingredients in
the formulated end-use products be submitted to the
Agency.
Rationale: Arsenic and chromium are commodity chemicals
with many non-pesticidal uses. Frequently, active
ingredients incorporated into formulated products are
not registered for manufacturing-use and the chemical
characteristics of each product are unknown. These data
will allow the Agency to determine these characteristics
for the individual products.
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11. While the data gaps are being filled, currently registered
manufacturing use products (MPs) and end-use products (EPs)
containing as sole actives or multiple actives, the chemicals
subject tfa this Registration Standard, may be sold, distributed*,
formulated and used, subject to the terms and conditlns
seclfied 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; Section 6 of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, authorizes the
Administrator to cancel a pesticide registration if he
determines that the pesticide will cause unreasonable adverse
effects on the environmentl. Based on available data, the
Administrator has not made such a determination as to
chromated and non-chromated arsenical wood preservatives.
The Administrator has authority under FIFRA sections
3(c)(2)(B) and 3(c)(7)) to require registrants and
applicants for registration to provide data needed to
support new or continuing registrations.
Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed and
evaluated and the Agency will determine if the data
.will affect the registration of chromated and non-chromated
arsenical wood preservatives.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain arsenic or chromium and arsenic as the
active ingredient(s), bear required labeling, and conform to
the product composition, acute toxicity limits, and use
pattern requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain either a salt
of chromium or a salt of arsenic and must be sold for the
purpose of formulating into an arsenical or chromated arsenical
wood preservative pesticide. Each MP formulation proposed
for registration must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts
of the active ingredient and inert ingredients which are
present in products, as well as impurities found at greater
than 0.1%.
To be registered or reregistered under this Standard,
end-use products (EPs) must contain a mixture of salts that
contain either arsenic or both arsenic and chromium, and
must be labeled for wood preservation only.
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2. Acute Toxlclty Limits
The AgencV will consider registration of technical grade,
manufacturing-use, and end-use products containing arsenic
or both arsenic and chromium provided that the product labeling
bears appropriate precautionary statements for the acute
toxiulty category in which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products,
and end-use products may be labeled only for the commodities
listed below. The Use Index lists all registered uses, as
well as approved maximum application rates and frequencies.
-Terrestrial, non-domestic, non-food uses on wood
D. REQUIRED LABELING
All manufacturing-use products, formulation intermediates,
and end-use products must bear appropriate labeling as specified
below, and in HO CFR 162.10 and PR Notices 83-2, 83-3 (as
appropriate). Appendix II contains information on label
requirements.
Wood preservative pesticide product containing arsenic
or both chromium and arsenic as active ingredient(s) may not
be released for shipment by the registrant after October 31, 1987
unless the product bears an amended label which complies with
the requirements of this Standard.
Wood preservative pesticide product containing arsenic
or both chromium and arsenic as active ingredient(s) 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 after
October 31, 1988 unless the product bears an amended label
which complies with the requirements of this Standard.
The following information must appear on the labeling:
1. Manufacturing Use Products
a. Ingredient Statement
The ingredient statement for manufacturing use
products must list the percentage of each component used in
the formulation of the chromated or non-chromated arsenical
which contributes to the pesticidal activity of the product.
b. Use Pattern Statement
All manufacturing-use products must state that
they are intended for formulation into end-use products for
wood preservation.
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c. Ecological Hazard Statement
All manufacturing-use products must bear the
following ecological hazard statement:
"This pesticide is toxic to fish. Do not
discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or public water unless this product
is specifically identified and addressed in an NPDES permit.
Do not discharge effluent to sewer systems without previously
notifying the sewage treatment plant authority. For guidance,
contact your State Water Board or regional office of EPA."
2. All End-Use Products: The following statements
must appear on the labeling of all end use products subject
to this Registration Standard.
a. Ingredient Statement
The ingredient statement for end-use products
must list the percentage of each component used in the
formulation of the chromated or non-chromated arsenical
which contributes to the pesticidal activity of the product.
b. Use Pattern Statement
All end-use products must be labeled for wood
preservation. Labeling must specify sites, which are listed
in Use Patterns, Section C.3. However, no use may be included
on the label where the registrant fails to agree to comply
with the data.requirements in the Data Appendices for
that use pattern.
3. End Use Products Labeled for Pressure Treatment
of Wood; In addition to the statement in (2) above, the
following statements must appear on end use products subject
to this registration standard and which are labeled for
pressure treatment of wood
a. Restricted Use Statement
"RESTRICTED USE PESTICIDE"
"For sale to and use only by certified applicators
or by persons under their direct supervision and only for
those uses covered by the certified applicators' certification.
Applicators must wear gloves impervious to
the wood treatment formulation in all situations where
dermal contact is expected (e.g., handling freshly treated
wood and manually opening cylinder doors). "
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b. Personal Protective Equipment Statement
t
"Individuals who enter pressure treatment
cylinders and other related equipment that is contaminated
with the wood treatment solution (e.g. , cylinders that are in
operation or are not free of the treatment solution) must
wear protective clothing, including overalls, jacket, gloves,
and boots, impervious to the wood treatment formulation. In
addition, individuals who enter pressure-treatment cylinders
must wear properly fitting, well-maintained, high efficiency
filter respirators (MSHA/NIOSH-approved for inorganic arsenic)
if the level of inorganic arsenic in the plant is unknown or
exeeds 10 micrograms per cubic meter of air (lOug/m^) averaged
over an 8-hour work period."
"Protective clothing must be changed when it
shows signs of contamination. Applicators must leave protective
clothing and workshoes or boots and equipment at the plant.
Worn-out protective clothing and workshoes or boots must be
left at the plant and disposed of in a manner approved for
pesticide disposal and in accordance with state and federal
regulations."
"Individuals in the work area of an arsenical
wood treatment plant must wear properly fitting, well-maintained
high efficiency filter respirators, MSHA/NIOSH-approved for
inorganic arsenic, if the level of inorganic arsenic in the
plant is unknown or exceeds 10 micrograms per cubic meter of
air (lOug/m^) averaged over an 8-hour work period.
"Note to user - Examples of acceptable materials for
protective clothing (e.g., gloves, overalls, jacket, and
boots) required during application and handling of inorganic
arsenicals are vinyl, polyvinyl chloride (PVC), neoprene, NBR
(Buna-N), rubber, and polyethylene."
c. Monitoring
"Air monitoring programs, procedures and record
retention and submission must be conducted in accordance with
the instructions on the attached labeling material."
d. General Work Practice Statements
"Applicators must not eat, drink, or use
tobacco products during those parts of the application process
that may expose them to the wood treatment formulation (e.g.,
manually opening/closing cylinder doors, moving trams out of
cylinders, mixing chemicals, and handling freshly treated
wood)."
"Wash thoroughly after skin contact, and before
eating, drinking, use of tobacco products or using restrooms."
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e. Disposal
"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."
f. Ecological Hazard Statement
"This pesticide is toxic to fish. Do
not discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans or public water unless this
product is specifically identified and addressed in an NPDES
permit. Do not discharge effluent to sewer systems without
previously notifying the sewage treatment plant authority.
For guidance, contact your State Water Board or regional
office of the EPA."
g. Visible Residue Statement
"Processes used to apply inorganic arsenical
formulations shall leave no visible surface deposits on the
wood, as defined by AWPA Standard C-l and AWPB Standards LP2
and LP22. (Visible surface deposits means a surface residue
or crystallization on the treated wood. Small isolated or
infrequent spots of chemical on otherwise clean wood shall be
allowed.) "
h. Permissible Exposure Limit (PEL) Monitoring
7rogram^^ ^7
The following must be included as labeling, with
each end-use product labeled for pressure treatement of wood:
"Implementation of the Permissible Exposure Limit (PEL)
Monitoring Program"
"Each arsenical wood treatment plant employer shall require
all employees potentially exposed to airborne inorganic
arsenic to wear properly fitting, well maintained, high
efficiency filter respirators, MSHA/NIOSH-approved for
inorganic arsenic for the entire period that the employees
are in the treatment application work area or engaged in any
activity associated with the treatment process. Alternatively,
to potentially relieve employees from the burden of wearing
respirators, the employer may implement a Permissible Exposure
Limit (PEL) Monitoring Program. This requirement became
effective on July 10, 1986. Any plant which begins operations
after April 10, 1986 will have 3 months from the date of
initial operation to implement this program."
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"All wood treatment plant employers who elect to implement
the PEL monitoring program must determine the current levels
of airborne arsenic, averaged over an 8-hour period, to
which their employees are exposed. Monitoring data must
be obtained in the same manner as described below under
"Monitoring and Measurements Procedures'."
"If the initial or subsequent monitoring demonstrates
that airborne inorganic arsenic in a work area is greater
than lOug/m^, all employees working in that area are required
to wear properly fitting, well-maintained, high efficiency
filter respirators, MSHA/NIOSH-approved for inorganic arsenic.
If in subsequent monitoring, at least two consecutive
measurements taken at least 7 days apart, the inorganic
arsenic levels are below lOug/m^, employees in those areas
may discontinue wearing the respirators except as discussed
in the "PEL checklist" below. However, if the employee
exposure is below lOug/m^ but above 5ug/m3, the employer shall
repeat monitoring at least every 6 months until at least two
consecutive measurement, taken at least 7 days apart, are
below Sug/m^. The employer may then discontinue monitoring
except as discussed in the 'PEL Checklist1 below."
"If the monitoring reveals employees are exposed to airborne
arsenic levels below Sug/m^, monitoring need not be repeated
except as discussed in the 'PEL Checklist' below."
"PEL CHECKLIST"
"In all cases where there has been a change in production,
process, control, or employee handling procedures, or if any
events in the .PEL Checklist occurred, or if, for any other
reasons an employer should suspect new or additional airborne
inorganic arsenic, additional monitoring that complies with
the requirements for initial monitoring shall be completed.
Responses to the Checklist will become part of the monitoring
records. Monitoring is required within 3 months if any of
the following events/questions on the checklist can be
answered in the affirmative with respect to any events which
may have occurred since the last monitoring report submitted
to the Agency."
"1. After the wood has been treated, have you
changed from hand stacking to mechanical stacking or from
mechanical stacking to hand stacking? If yes, when?"
"2. Has your production capacity increased
significantly? If yes, when?"
"3. Have you changed from a ready-to-use or dilute
concentrate to a mix-it-yourself formulation? Has the
proportional amount of arsenic in the solution increased,
e.g., have you shifted from CCA Type A or C to type B? If
yes, when?"
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"4. Has a significant (i.e., reportable under the
Comprehensive lEhvironraental Response, Compensation, and
Liabililty Act of 1980 (Superfund), 42 U.S.C. 9601 e_t seg.),
spill occurred? If yes, when?"
"5. Is treated wood being retained on the drip pad
for less time? If yes, when?"
"6. Have there been any other production, process,
control or employee handling procedure changes which could
result in new or additional airborne inorganic arsenic?
Identify change, and when it occurred."
"MONITORING AND MEASUREMENT PROCEDURES"
"The Employer shall collect personal air samples, including at
least one sample which is adequate to represent typical
conditions for a full work shift (at least 7 hours) for each
job classification in each work area. Sampling should be
done using a personal sampling pump calibrated at a flow
rate of 2 liters per minute. Samples should be collected on
0.8 micrometer pore size membrane filters (37mm diameter).
The method of sampling analysis should have an accuracy of
not less than + or - 25 percent (with a confidence limit of
95 percent) for 10 micrograms per cubic meter of air (lOug/m^),
and + or - 35 percent (with a confidence limit of 95 percent)
for concentrations of inorganic arsenic between 5 and 10ug/m3."
"Monitoring may be conducted through a request made to
the Occupational Safety and Health Administration (OSHA) for
monitoring assistance, which may be provided free of charge
under the terms of the OSHA consultation program as provided
under section 7(c)(l) of the OSHA Act, or by employees or
contractors :of the employer's choosing."
"The Environmental Protection Agency (EPA) may direct that
remonitoring take place at statistically selected establishments
to assure that the Checklist is effective in identifying
events which increase airborne arsenic. Selected employers
will be notified by EPA/State enforcement representatives.
The employer will be responsible for obtaining current air
monitoring data within the time specified in the remonitoring
notification and for submitting these data and reports to the
EPA as described below."
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DATA SUBMISSION AND CERTIFICATION
"The employer shall establish and maintain accurate records
which include "responses to the PEL Checklist and all monitoring
reports. The annual records or copies thereof shall be submitted
to the U.S. Environmental Protection Agency, Office of Pesticides
and Toxic Substances Office of Compliance Monitoring (EN-
342), 401 M St., SW, Washington, D.C. 20460. All records
submitted will be certified by the employer as accurate and
in compliance with all calibration, analytical and sampling
requirements outlined in this program. If the employer
received assistance from an OSHA 7(C)(1) consultant, that
consultant's report to the employer will be an acceptable
record of calibration, analysis, and monitoring requiring no
additional certification."
4. All End Use Powder Formulations Labeled For
Pressure Treatment of Wood; In addition to those statements
in D(2) and (3) above, the following statement must appear on all
powder formulations labeled for pressure treatement of wood:
"A closed emptying and mixing system must be
used for all powder formulations of the inorganic arsenicals.
A closed system is defined as any containment which prevents
the release of subject chemicals into the surrounding external
environment, except that the release of incidental amounts of
chemical during equipment loading and periodic clean-out or
maintenance operations shall not be deemed a breach of
containment."
5. End Use Products Labeled for Brush on Treatment;
In addition to the statements in D(2) above, all end use
products labeled for brush on treatment must bear the following
statements:
• a' Protective Clothing
"Applicators must wear gloves (e.g.,
rubber, vinyl or neoprene) impervious to the wood treatment
solution in all situations where dermal contact is expected
(e.g., during the application process and handling freshly
treated wood). "
"Applicators must wear disposable coveralls
(e.g., vinyl, or polyethylene) or other similar impermeable
clothing during the application process where dermal contact
is expected."
"Protective clothing must be changed when
it shows obvious signs of contamination. Launder non-disposable
protective clothing separately from other household laundry.
Dispose of worn-out protective clothing in a manner approved
for pesticide disposal and in accordance with state and
federal regulations."
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b. General Work Practice Statement
"Applicators must not eat, drink, or use
tobacco products during those parts of the application process
that may expose them to the wood treatment formulation."
"Wash thoroughly after skin contact and
before eating, drinking, use of tobacco products, or using
restrooms."
c. Disposal
"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."
d. Ecological Hazard Statement
"This product is toxic to fish. Do not
contaminate water by cleaning of equipment or disposal of waste.
e. Use Pattern Statement
"For application to the cut ends of
pressure-treated wood only. Do not dilute or mix with other
products."
"For commercial construction use only.
Not for household use."
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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 chromated or
or non-chromated arsenicals as the sole active ingredient
or as one of multiple active ingredients are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed In Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard.
Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products.
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B. End use products containing chromated or non-chromated
arsenicals as ^he sole active ingredient or as one of
multiple active ingredients 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 exemptlon3, 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.
5. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
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.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
4 Registrations granted after issuance of this Standard
will be conditioned upon submission or citation of the data
listed in this Registration Standard.
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Standard, you will be required to submit or cite generic
data relevant? to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit- the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
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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)(ill).
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.
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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 (a) for which the data are needed"!
E. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either EPA's Pesticide Assessment Guidelines or the Reports
of Expert Groups to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the timeframe
for submission of the data, nor will extensions generally be
given to conduct studies due to submittal of inappropriate
protocols.
F. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
in writing to the Office of Compliance Monitoring.
EPA will view failure to request an extension before
the response deadline as a waiver of any future claim that
there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline
for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome. Time extensions
may be considered when joint data development is planned,
or when the Agency must approve a new or modified protocol
before the study can be begun.
-47-
-------
A request -for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
G. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
-48-
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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.
-49-
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
j_-
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.
-50-
-------
f IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing (name of
pesticide) 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).
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
-51-
-------
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 (name of pesticide)
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason 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 (name of pesticide) alone
or in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
-52-
-------
c. Three! copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing (name of pesticide) either
Intrastate Products containing (name of p
as sole active ingredient or in combinati
__^__^ ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
E. Addresses
The required information must be submitted to the following
address:
Henry Jacoby PM 21
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
-53-
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I. DATA APPENDICES
-------
TGUIDE-1
f - GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA « Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = . End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table.
-------
TGUIDE-2
4. Does EPA frave data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If- column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted,this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHRCMATED AND NON-CHRCMATED ARSENICAL TECHNICAL PRODUCTS
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data?1 Citation*
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§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
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TGAI
All
All
All
TGAI
All
No
No
No
No
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All
All
All
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
-------
TABIE A
GENERIC DATA REQUIREMENTS FOR CHROMATED AND NON-CHROMATED ARSENCAL TECHNICAL PRODUCTS
Data Requirement
•Test Use
Substance Patterns
Does EPA Bibliographic Must Additional Time Frame
Have Data?1 Citation1 Data be for
Submitted? Submission
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics "
(Continued)
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Other
64- 1
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- PH
- Storage Stability
Requirements :
- Submittal of samples
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
TGAI, PAI
All
All
All
All
All
All
All
All
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
I/ Not applicable. Although product chemistry data may have been submitted In the past, the Agency has determined that
these data must be resubmltted 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.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR [X] of CHRCMATED AND NON-CHROMATED ARSENICALS ([X]CrAs and [X]As)
Data Requirement
§158.130 Environmental Fate -
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Son, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Targ(
Test •
Substance
Continued
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
»t TEP
Use
Patterns
H
H
H
H
H
H
H
H
H
H
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
No
Must Additional Time Frame
Data be for
Submitted? Submission
Reserved
Reserved
2/
No
Reserved
2/
No~
2/
No
2/
No
Reserved
Reserved
Reserved
Organisms
5"?
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR Cr of CHRCMATED ARSENICALS ( [X]CrAs)
Data Requirement
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
Test
Substance
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
Use
Patterns
H
H
H
H
H
H
H
H
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
Must Additional
Data be
Submitted?
Reserved
Reserved
Reserved
Reserved
Reserved
I/
No
Reserved
Reserved
Time Frame
for
Submission
MOBILITY STUDIES:
163-1 - Leaching and
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TGAI or PAIRA H
TEP H
TEP H
No
No
No
Reserved
Yes
3/
12 Months
Reserved
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR Cr of CHROMATED ARSENICALS ([X]CrAs)
Data Requirement
§158.130 Environmental Fate -
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
161-3 - Forestry
161-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Targ<
Test
Substance
Continued
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
gt TEP
Use
Patterns
H
H
H
H
H
H
H
H
H
H
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
No
Must Additional Time Frame
Data be for
Submitted? Submission
Reserved
Reserved
2/
No
i/
Reserved
2/
No
2/
No
2/
No
Reserved
Reserved
Reserved
Organisms
(o\
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR As of CHROMATED AND NON-CHRQMATED ARSENICALS ([X]CrAs and [X]As)
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted? Submission
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA H
Photodegradat ion
161-2 - In water TGAI or PAIRA H
161-3 - On soil TGAI or PAIRA H
161-4 - In Air TGAI or PAIRA H
METABOLISM STUDIES-LAB:
v
162-1 - Aerobic Soil TGAI or AEP H
162-2 - Anaerobic Soil TGAI or PAIRA H
5/
162-3 - Anaerobic Aquatic TGAI or AEP H
5/
162-4 - Aerobic Aquatic TGAI or AEP H
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA H
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab) TEP H
163-3 - Volatility (Field) TEP H
No
No
No
No
No
No
No
No
No
No
No
Reserved
Reserved
Reserved
Reserved
Yes
2/
No
Yes
Yes
Reserved
Yes
V
Reserved
«•
27 Months
27 Months
27 Months
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR As of CHROMATED AND NON-CHRCMATED ARSENICALS ([X]CrAs and [X]As)
Data Requirement
§158.130 Environmental Fate -
DISSIPATION STUDIES-FIELD;
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tame Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Targ<
Test
Substance
Continued
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
3t TEP
Use
Patterns
H
H
H
H
H
H
H
H
H
H
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
No
Must Additional Time Frame
Data be for
Submitted? Submission
Reserved
Reserved
2/
No
Reserved"
2/
No
2/
No
2/
No
Reserved
Reserved
Reserved
Organisms
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHROMATED AND NON-CHROMATED ARSENICALS ([X]CrAs and [X]As)
Data Requirement
§158.130 Environmental Fate
SPECIAL STUDIES -LAB:
Availability Studies
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
- Continued
5/
Aqueous Availability AEP H Partially GS-0647-001
5/
Soil Availability AEP H No
SPECIAL STUDIES - EXPOSURE
Ambient Air Availability Studies
[X]
Total Cr
Speciated Cr
As
TEP H No
TEP H No
TEP H No
TEP H NO
Must Additional
Data be
Submitted?
t
L/
Yes
Yes
*/''
Reserved
7/
Yes
Reserved
Yes~
Time Frame
for
Submission
M
12 Months
12 Months
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHROMATED AND NON-CHROMATED ARSENICALS ([X]CrAs and [X]As)
Data Requirement
Test ' Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted? Submission
§158.110 Reentry Protection
132-1
132-2
133-3
133-4
- Foliar Dissipation
- Soil Dissipation
- Dermal Exposure
- Inhalation Exposure
TEP
TEP
TEP
TEP
H
H
H
H
No
No
No
No
Reserved
Reserved
Reserved
Reserved
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHROMATED AND NON-CHROMATED ARSENICALS
§158.130 Environmental Fate
I/ For all applied end-use products, tests are to be made after product Is applied with normal processing techniques
and allowed to cure In usual manner. Products to be tested will be the treated wood or wood products as
avallabe In the marketplace.
2/ No use pattern Identified by this Standard which requires this data.
"3X Field volatility study reserved pending the result of the laboratory volatility study.
"^/ Some chromated arsenical wood preservative products may be formulated as tank mixes. Additional data may be
~ required on these mixes at a later date.
5/ AEP = applied end-use product; tests must determine the availability of Cr and As to aqueous and soil media
after application of a formulated end-use product to wood.
6/ Study reserved pending results of volatility and availability studies.
T/ Exposure study required to determine the levels of airborne total Cr and Cr/As ratio In air of [X]CrAs and
~~ [X]As treating plants. An acceptable speclated Cr In air study may be substituted for the total Cr air
availability study. Protocols should be submitted for review prior to the Initiation
of this study and be consistent with Subdivision U of the Pesticide Exposure Guidelines.
8/ Study Is reserved pending the results of the total Cr In air study.
9/ Monitoring of As In air of treating plants as required under the Federal Register Notice
~ (51 FR 133*0 January 10, 1986.
-------
TABLE A
GENERIC DATA REQUIRIMENTS FOR CHROMATED AND NON-CHROMATED ARSENICALS
Date Requirement
Test . Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional
Dnta be
Submitted
Time Frame
for
Submission
§158.135 Toxicology
ACUTE TESTING;
81-1 - Acute Oral Toxicity - Rat TGAI
81-2 - Acute Dermal Toxicity TGAI
- Rabbit
81-3 - Acute Inhalation Toxicity TGAI
- Rat
81-7 - Delayed TGAI
Neurofoxicity - Hen
SUBCHRONIC TESTING;
82-1 - 90-Day Feeding:
- Rodent, and TGAI
- Non-rodent (Dog) TGAI
82-2 - 21-Day Dermal - Rabbit TGAI
82-3 - 90-Day Dermal - Rabbit TGAI
82-4 - 90-Day Inhalation: TGAI
- Rat
82-5 - 90-Day Neurotoxicity:
- Hen TGAI
-Mammal TGAI
B
B
B
B
N/A
N/A
N/A
N/A
B
N/A
N/A
B
B
Yes
Yes
Yes
No
Yes
00159870,
GS-0647-02
00159870,
GS-0647-02
00120843
00159870
No
I/
)
I/
No
I/
No
V
No
No
No
No
N/A
N/A
No
No
-------
TABIE
GENERIC DATA REQUIREMENTS FOR CHROMATE^RD NON-CHROMATED ARSENICALS
Data Requirement
§158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxlclty -
2 species:
- Rodent, and
- Non- rodent (Dog)
83-2 - Oncogenlclty -
2 species:
- Rat (preferred), and
- Mouse (preferred)
83-3 - Teratogenlclty -
2 species:
- Rodent other than
rat
- Rabbit
83-1 - Reproduction - Rat
2-generatlon
MUTAGENICITY TESTING
8*4-2 - Gene Mutation (Ames Test)
81-2 - Structural Chromosomal
Test
Substance
..
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
B
B
B
B
B
B
B
B
B
Does EPA
Have Data?
Yes
Yes
Yes
Yes
No
No
No
Yes
Yes
Bibliographic
Citation
00159870,
GS-06'47-02
00159870,
GS-0617-02
00159870,
GS-0617-02
00159870,
GS-0617-02
GS-0617-02
GS-0617-02
Must Additional
Data be
Submitted?
No
No
No
No
2/
[As] Yes3/
[Cr] Yes
2/
[As] Yes3/
[Cr] Yes
V
[As] YesV
[Cr] Yes
No
No
Time Frame
for
Submission
•
15 Months
15 Months
39 Months
39 Months
Aberration
84-'4 - Other Genotoxlc Effects TGAI
B
Yes
GS-06'47-02
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHROMATED ARSENICALS
Data
§158
Requirement
.135 Toxicology - Continued
Test
Substance
-.-.
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
SPECIAL TESTING
85-1
85-2
86-1
- General Metabolism
- Dermal Penetration
- Domestic Animal
TEP
Choice
Choice
B
B
B
Partially
No
Yes
03-06*47-02
05-06*47-02
Must Additional
Data be
Submitted?
5/
Yes
No
No
Time Frame
For
Submission
21 Month's
Safety
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHROMATED AND NON-CHROMATED ARSENICALS
§158.135 Toxicology - Continued
I/ There Is no technical grade active Ingredient for the chromated arsenlcals. The acute toxlclty of arsenic
and chromium Is thoroughly documented In public literature and acute toxlclty tests on the separate lonn
are not necessary. However, acute toxlclty tests are required on all formulated products (see tables B and C).
2/ Teratogenlclty study on arsenic to be submitted by July 198? as per the Special Review Data Call-in letter dated
April 7, 1986.
3/ Test material should be a formulated chromated arsenical product.
5/ Test material should be a formulated chromated arsenical product. This test will satisfy the reproduction
study requirement for both [As] and [Cr],
5/ The Agency requires a repeated-dose metabolism study on a rodent other than the rat. The Agency should be consulted
~~ regarding the test material. The preferred test material Is a formulated chromated arsenical. The protocol must
Include determination of blood levels of chromium and arsenic during treatment.
10
-------
GENERIC DATA REQUIREMENTS FOR CHROMATED AND NON-CHROMATED ARSENICALS
Data Requirement
Test I/ Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§138.115 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxlclty TEP
71-2 - Avian Subacute Dietary TEP
Toxiclty
- Upland Game Bird, and
- Waterfowl
71-3 - Wild Mammal Toxicity TEP
71-U - Avian Reproduction TEP
- Upland Game Bird, and
- Waterfowl
71-5 - Simulated Field Testing TEP
- Mammals, and
- Birds
- Actual Field Testing TEP
- Mamnals, and
- Birds
B, D, H No
B, D, H Partially 000104061
000106113
B, D No
B No
B
B
No
No
Yes
Yes~
No
No"
I/
5
V
No"
V
No"
9 Months
9 Months
7f
-------
TABLE A
GENERIC DATA REQUIREMENTS CHROMATED AND NON-CHROMATED ARSENICALS
Data Requirement
Test Use Does EPA Bibliographic
Substafice Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.145 Wildlife and
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Toxiclty TEP
- Coldwater Fish Species,
and
- Warmwater Fish Species
72-2 - Acute Toxlcity to TEP
Freshwater Invertebrates
72-3 - Acute Toxlcity to TEP
Estuarlne and Marine
Organisms
- Fish
- Mollusk
- Shrimp
72-1 - Fish Early Life Stage, TEP
and
- Aquatic Invertebrate
Life-Cycle
72-5 - Fish - Life-Cycle TEP
B, D, H Partial
D
D
000099363
Yes~
B, D, H No
D No
No
No
Yes
<
Yes"
7/
Yes
8/
Reserved
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
15 Months
15 Months
13L.
-------
TAME A
GENERIC DATA REQUIREMENTS FOR CHROMATED AND NON-CHROMATED ARSENICALS
Data Requirement
Test .. I/ Use
Substance Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.145 Wildlife and
Aquatic Organisms - Continued
72-6 - Aquatic Organism TEP
Accumulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
72-7 - Simulated Field Testing TEP
- Aquatic Organisms
- Actual Field Testing
-Aquatic Organisms
D
D
No
Reserved
No
Reserved
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHROMATED AND NON-CHROMATED ARSENICALS
§138.145 Wildlife and Aquatic Organisms - Continued
I/ There Is no actual technical grade of-.the active Ingredient for chromated arsenlcals. Therefore a typical end-use
product should be used as the test material.
2/ Both studies cited may be upgraded If the percent active Ingredient Is clarified. Study assumed 100% active
Ingredient; percent a.l. used must be documented.
3/ Not usually required unless there Is a unique exposure situation for feral animals. Toxicology acute testing
suffices.
V Not required because exposure to avlan and mammal species Is expected to be minimal.
5/ Study may be upgraded If dissolved oxygen measurements and pH values, as required by the Pesticide Assessment
Guidelines; Subdivision E, are submitted.
6/ Required to support use of treated wood In estuarlne/marlne environments.
7/ Required because of expected continuous exposure of aquatic organisms through leaching of chromated arsenlcals
from submersed wood.
a) A flow-through system should not be used. Rather, two tanks, a test tank and a "leaching tank" should be
set up and the water should circulate between the two. The first tank, containing the ter.t organisms, should
be set up as In a normal study but with a provision for reclrculatlon. The second tank should be large, at
least 200 gallons, so that waste products may be diluted to maintain good water quality. Data should be
submitted showing that materials used to construct the tanks do not absorb or adsorb the Ions of Interest
to a significant extent. In this second tank, the CCA-treated wood should be placed In such a way as to
maximize surface area, I.e., using 1" boards spaced apart rather than using 4" X 1" posts. The volume of
wood used should be l/100th of the volume of the tank. Three replications of each treatment group should
be performed.
b) A control tank system Identical to the treatment system should be performed concurrently using, In place of
the treated wood, an equal volume and surface area of untreated wood of the same species (untreated control).
Additionally, a negative control, using no wood at all, should be performed.
c) The concentration of total chromium, and arsenic, and additional Ions should be measured biweekly and the
Ions should be speclated as to valence state.
d) To Insure that the water quality at the beginning of the test Is the highest possible, the dilution water,
both fresh and salt, should be reconstituted from delonlzed water and chemicals of at leant reagent-grade
purity should be used. Refer to "Methods for Acute Toxlclty Tests for Fish, Macrolnvertebrates and
and Amphibians", EPA-660/3-75-009, April 1975. The dilution water should be assayed for chromium, arsenic,
and additional Ions at test Initiation. All other test standards and data reporting should conform to the
guidelines for a fish early life-stage test as set forth In EPA's Pesticide Assessment Guidelines:
Subdivision E. In this way, both the amount of chromium, arsenic, and additional Ions lenchlng from the
wood can be estimated and the subchronlc effects of these Ions on fish can be determined.
8/ Reserved pending outcome of acute and subchronlc aquatic testing.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS FOR CHROMATED AND NON-CHR')MATED ARSENICALS
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data?1 Citation1
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.120 Product Chemistry
Product Identity;
61-1 - Product Identity and MP
Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
All
All
All
All
All
All
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
I/ Not applicable. 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 be~n Introduced and
previously submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
75"
-------
TABLE B
PRODUCT .SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS FOR CHROMATED AND NON CHROMATED ARSENICAL
1
Data Requirement Test
Substance
Use Does EPA Bibliographic Must Additional Time Frame
Pattern Have Data? Citation Data be for
Submitted? Submission
§158.135 Toxicology
ACUTE TESTING
81-1 -
81-2 -
81-3 -
81-H -
81-5 -
81-6 -
81-7-
Acute Oral Toxlclty -
Acute Dermal Toxlclty
- Rabbit
Acute Inhalation Toxlclty
Primary Eye
Irritation - Rabbit
Primary Dermal
Irritation - Rabbit
Dermal Sensltlzatlon -
Guinea Pig
Acute Delayed Neurotoxlclty -
Hen
MP
MP
MP
MP
MP
MP
MP
B
B
B
B
B
B
B
No
No
No
No
No
No
No
I/
Yes
I/
Yes
I/
Yes
I/
Yes
I/
Yes
Yes"
2/
No
*
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
I/ The studies are to be performed on a rodent other than the rat. The Agency may waive certain acute
studies on specific formulations of copper chromated arsenlcals If adequate data are already on file
for a copper chromated arsenical formulation which the Agency deems applicable, based on
close similarity of composition.
2/ The Agency does not ordinarily require neurotoxlclty testing of pesticides which are not organophosphatos.
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING CHROMATED AND NON-CHROMATED ARSENICALS
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern llave Data?1 Cltatlonl
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.120 Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning
Materials and Manufacturing
Process EP
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis of
Product Samples
62-2 - Certification of
Ingredient Limits
EP
EP
All
All
All
No
No
No
N/A
N/A
N/A
Yes"
Yes
Yes
6 Months
6 Months
6 Months
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each end-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/ Only the source and a description of As, Cu, Cr, and any other active ingredients must be provided. This is
~~ to include company name and address, product name, percent by weight, and technical data sheets, and
EPA Registration Number, if a registered product.
17
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END USE PRODUCTS CONTAINING CHROMATED AND NON-CHROMATED ARSENIOALS
Data
§158.
ACUTE
81-1
81-2
81-3
81-1
81-5
81-6
Requirement Test
Substance
135 Toxicology
TESTING
- Acute Oral Toxiclty - EP
- Acute Dermal Toxiclty EP
- Rabbit
- Acute Inhalation Toxiclty EP
- Primary Eye EP
Irritation - Rabbit
- Primary Dermal EP
Irritation - Rabbit
- Dermal Sensltlzatlon - EP
Guinea Pig
81-7- Acute Delayed Neurotoxlclty - EP
Hen
Use
Pattern
B
B
B
B
B
B
B
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
Must Additional
Data be
Submitted?
Yes"
I/
Yes"
I/
Yes""
Yes"
I/
Yes
V
Yes
?/
No
Time Frame
for
Submission
t
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
I/ The studies are to be performed on a rodent other than the rat. The Agency may waive certain acute
studies on specific formulations of copper chromated arsenlcals If adequate data are already on file
for a copper chromated arsenical formulation which the Agency deems applicable, based on
close similarity of composition.
2/ The Agency does not ordinarily require neurotoxlclty testing of pesticides which are not orgnnopho.sphates.
-------
II. LABELING APPENDICES
-------
§ 162.10 Labeling requirements.
(a) General—41) Contents of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
lations In this Part. The contents of a
label must show clearly and promi-
nently the following:
-ttJ The name, brand, or trademark
under which the product Is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(11) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section:
(ill) The net contents as prescribed
in paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
-------
Environmental Protection Agency
§ 162.10
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the Iftoelmg by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(11) All required label text must*
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary.
ell labeling-requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label-(i) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product For pur-
poses of this Section, and the mis-
branding provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer. if it Is a part of the package as
customarily distributed or sold.
(ii) Tank can and other bulk con-
tainers— < A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-169. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported In a tank car. tank truck or
other mobile or portable bulk contain-
er. a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use. shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(qXlXA) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
( 162.15, is misbranded if its labeling is
false or miRit^^ing JQ any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misoranaing 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;
(ill) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
(iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or Indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active •
-------
§ 162.10
40 CFR Ch. I (7-1-85 Edition)
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe," "nonpoison-
ous," "noninjurious," "harmless" or
"nontoxic to humans and pets" with
or without su
and shall be expressed in conventional
American units of fluid ounces, pints.
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid!, viscous or pressurized, or is a
mixture of liquid and solid, the net
content 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, Le., "1 pound 10 ounces" rather
than "26 ounces."
(5) 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 is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated mtnifmim is not permit-
ted* In no case shall-the average con-
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 time of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.," or the phrase "EPA Reg.
No." The registration number ff?MI be
set In type of a stee and style similar to
other print on that part of the label
on which It appears and shall run par-
allel to It The registration number
and the required Identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
-------
Environmental Protection Agency
§ 162.10
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
-------
§ 162.10
40 CFR Ch. I (7-1-85 Edition)
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
MftZttfl? ndcflors
01
IV
OnriLO.
MMMtontC.
Up to W«J Induing 90
OarmdLD..-
mg/Stor.
Up to tni Muting 200
mg/kg.
Conwf**, oomMl
opacity not njvwifefe
V f^l !•
f QBjr*.
From SO tvu 800 mg/kg
From .2 thru 2 mg/IUr—
Fiom 200 fwu 2000 _
From 800 ffiru 6000 mg/
From 2. tvu 20 mg/M«r_
F/om tOOO tvu 20XX»_
mg/
iwmfcto ««Nn 7
dy: Mutton
pwvtnQ tef 7 oiys.
SMV* MUtton « 72
Mutton
nMton«72
hour*.
hours.
Oiwtor thin 20 ing/Mr.
-------
Environmental Protection Agency
§ 162.10
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment Is not
required on the front panel except as
described in paragraph (hXD(iiiXA) of
this section. The applicant jnay. how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall Be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Sin of label front pan* in aquare
inches
S and under
AiXA* 5 to 10
At**" «0«o «5
*t*P~ l?%>30
rVarM
»- •---
FUBIU
Requred
«grui
•Oft. tf
capitals
6
10
12
14
10
"Map out
of reach of
raSjaiii • it**
wwn
6
6
6
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic *"''T»»I«. precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Tondty
catagory
nto by toxioity category
CM. Inhalation, or dermal toacfty
Skin and eye tocal effects
Fatal (poisonous) « eiraao»ed (Inhaled or abeerbad
through aktaj. Oo not breathe vapor (duct or apray
miaU. Oo not oat In eyea. en akin, or on etoMng
ay ba fetal I axafcwd CM*ad or
through tha eJdnJ. Do not breathe vapor* (dual or
apray avaO. Do not 901 In eyea. 'on aUn. or on
Coneeha. MUSS* eye and aUn damage (or
MMonl. Do not got at eyas, on okh. or on
otoMng. Wear goggle* pt fece aMakt and rubber
otove* «*»en hanolng. HirmM or fetal • OMtowed
(ApproprtM ** Od awamant wquked.)
Cau**i eye (and aMn] tittsiion. Oo not get at eye*,
AM ^a*an ** j>BMaMka*MM a^kaMeBBAal aV eiMMav^ieVkaaBMtf iTA»..
on OTV or on uuJVe^ nvinau • w«ww& i^P*
IV.
Avoid
a^a
|V
CNo
t^L^* ^^ ^**^^m*
IOUH or wpny
fo^M or cMMnQl.
Avoid oorHart wMh ahkv
Oat
»•»•»•» or ««*> •*» planty of
(No |
iiaojutod.1
(11) Environmental hazard*. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident,
injury or damage. Examples of the
hazard statements and the circum-
-------
§ 162.10
40 CFR Ch. I (7-145 Edition)
stances under which they are required
follow:
(A) If a pesticide intended for put-
door use contains an active ingredient
with a mammalian acute oral LDM of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for put-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avlan acute oral LDM of 100
mg/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide, isJToxic to Wildlife" is
required. "*"'
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flashpoint
Required tort
(A) PNEMUMZED OONTMNEMS
Flash point at or below 20* F; « there to a tashbacfc at
any vaNe opening.
Flash point above 20*Fandnotovereo*For«f»e
tame extension to more than 18 in long at a distance
o« 6 in from the flame.
Al other pretsurtref) eontairtf*
(B)NONPttt
Al ar hate* •*>* *-
Above 70* F and w o"^*0" *
A^n«* HIT F ««J nrrt c«»r 1«UV P
Extremely tammeble. Oontents under pressure. Keep away from
•re, sparks, and healed surfaces. Do not puncture or incinerate
container. Exposure to temperatures above 130* F may cause
bursting.
Flammable. Contents under pressure. Keep away from heat
Exposure to temperatures above 130* F may cause bursting.
Content! under pressure. Do not use or store neer heat or open
tame. Do not puncture or Incinerate container. Exposure to
temperatures above 130* F may cause bursting.
Extrwnrty tanrabt*. KMP amy torn *rt, spartis, and twated
ftrfacar
Do no( UM or ftort HMT hMt or open Aamt.
(i) Directions for Cte-U) General
requirements—V, Adequacy and clar-
ity of directions. Directions for use
must be stated In terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(11) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a reference to
the directions for use In accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular" and
(C) The Administrator determines
that it is not necessary for tuch direc-
tions to appear on the label
(ill) Exceptions to requirement for
direction for u*t-4A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
-------
Environmental Protection Agency
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that*
(/) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type
-------
§162.11
40 CFR Ch. I (7-145 Edition)
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22.1976. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth In
this subsection, and shall be marketed
as separate products with differen
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of 5 162.10(J)(2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbranding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted fhall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(i) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
table in { 162.10(h)(l)(iv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use. the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicatorc, the following statement is
required: "For retail.sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If.
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. [Reserved]
(40 PR 28268. July 3. 1975; 40 FR 32329.
Aug. 1. 197S; 40 FR 36571, Aug. 21. 1975, as
amended at 43 FR 5786. Feb. 9.1978)
-------
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 centere.i
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 i-s 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)]
7?
-------
SUMMARY- 2
It em 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 hezard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162. 10(h) (1 ) (i ) ]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h) (1) (iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h) (l)
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) ].
-------
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)3
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether :
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
'appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
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, dati 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.
-------
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/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Inmedi.itely
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.
-------
SLMMARY-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 base!
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I. II, and III
All products
where pre-
cautionary
labeling
aj^pears on
other than
front j>anel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category It
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
SA, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
tr^the Agency
All products
All products
PLACEMENT ON IABEL
REQUIRED
None
'Pop center
of front
panel
Inmediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Inmediately
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" oust 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
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20eF; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20 eF.^
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.
Keen away from fire, spares.
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 130eF
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 hewing
"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.
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, nust bear explicit instructions about pesticide disposal. The
statements listed belcw contain the exact wording that nust appear on
the label of these products:
1. The labels of all products, except domestic use, nust 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 dental toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhalation toxicity
nust 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 Appe.idix) or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste nust bear the following pesticide disposal
statement:
"Pesticide wastes are toxic. Inproper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, nust 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 nust bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
-------
PEST/DIS-2
P003
P070
P004
P005
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 ACL7TE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with RCRA I and CAS t
[40 CFR 261.33(e)]
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine (Avitro 1)
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts
not otherwise specified)
Cyanogen chloride
Dieldrin
0,O-Diethyl S-[2-ethylthio)ethyl]
phospnorodithioate (disulfoton)
0,0-Diethyl O-pyrazinyl
phosphorothioate (Zinophos*)
Dimethoate
0,0-Dimethyl O-p-nitrophenyl
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall
Enrlrii
Famphur
Fluoroacetami de
Heptachlor
Hexachlorohexahydro-exo,exo-
dimethanonaphthalene (Isodrin)
Hydrocyanic acid
Methomyl
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
PC.-71
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
loo
-------
PEST/DIS-3
Strychnine and salts P108 57-24-9
60-41-3
0,0,0,0-Tetraethyl P109 3689-24-5
dithicpyrophosphate (sulfotepp)
Tetraethyl pyrophosphate Pill' 107-49-3
Thallium sulfate P115 7446-18-6
Tniofanox P045 39196-18-4
Toxaphene P123 8001-35-2
Warfarin (>0.3%) P001 81-81-2
Zinc phosphide (>10%) P122 1314-84-7
50 ACTIVES
F027
F027
F027
P027
F027
5324-22-1
35109-57-0
136-25-4
327-98-0
70-30-4
II. PESTICIDES DERIVED FROM TRI-, TETRA-, AND PENTACHLDRDPHENOLS
[40 CFR 261.31]
2-Chloroethyl 2-(2,4,6-trichloro-
phenoxy) ethyl ether
DehydroabietylaniTonium
pentachlorophenoxide
Erbon
Oethyl O- ( 2 , 4 , 5-trichlorophenyl )
ethylphosphcnothioate
2,2' -Methylenebis
(3,4, 6-trichlorcphenol )
( Hexachlorcphene )
— Potassium salt of
—Sodium salt of
— Disodium salt of
Pentachlorophenol
— Potassium sajLt of
—Sodium salt of
—Zinc -salt of
—Zinc salt of N-alkyl
(CI&-CIB ) -1 i 3-propanediamine
— Pentachlorophenyl laurate
Potassium trichlorophenate (2,4,6)
Potassium trichlorophenate (2,4,5)
Silvex
~2-Butoxyethyl ester
— Butoxypolypropoxypropyl ester
— Butoxypropyl ester
— Diethanolamine salt
— Diisopropanolamine salt
— Dimethylamine salt
— Dipropylene glycol isobutyl
ether ester
--Ethanolamine salt
— 2-Ethylhexyl ester
—Isooctyl ester
P027
P027
P027
P027
F027
F027
P027
F027
P027
F027
P027
P027
F027
F027
F027
P027
F027
F027
F027
P027
P027
P027
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
-------
PEST/DIS-4
—Isppropanolamine salt F027 53404-13-0
—Monchydroxylaluminum salt F027 69622-82-8
—Polyprcpoxypropyl ester F027 83562-66-7
—Potassium salt F027 2818-16-8
—Prqpylene glycol isobutyl F027 53466-84-5
ether ester
—Sodium salt F027 37913-89-6
—Triethanolamine salt F027 17369-89-0
—Triethylamine salt P027 53404-74-3
—Triispprcpanolamine salt F027 53404-75-4
—Tripropylene glycol isobutyl F027 53535-30-1
ether ester
Sodium 2-(2,4,5-trichlorophenoxy) P027 3570-61-4
ethyl sulfate
Tetrachlorophenols F027 25167-83-3
—Alkylamine*amine salt (as in F027
fatty acids of coconut oil)
—Potassium salt P027 53535-27-6
—Sodium salt P027 25567-55-9
2,4,5-Trichloraphenol F027 95-95-4
2,4,6-Trichlorophenol P027 88-06-2
2,4,5-Trichlorophenol salt of P027 53404-83-4
2,6-bis[ (dimethylamino)methyl]
eye1dhexanone
2,4,5-Trichlorophenol,-sodium salt F027 136-32-3
2,4,6-Trichlorophenol, sodium salt F027 3784-03-0
2,4,5-Trichlorophenoxyacetic acid F027 93-79-8
—Alkyl C-12 amine salt F027 53404-84-5
—Alkyl C-13 amine salt F027 53404-85-6
—AlXyl C-14 amine salt P027 53535-37-8
--fl,N-diethylethanolamine salt P027 53404-86-7
—DimethylamLne salt P027 6369-97-7
—N,N-dimethyllinoleylamine salt P027 53404-88-9
—N,N-dimethyloleylamine salt P027 53404-89-0
—N-oleyl-l,3-propylene F027 53404-87-8
diamine salt
—Sodium salt P027 13560-99-1
—Triethanolamine salt P027 3813-14-7
—Triethylamine salt F027 2008-46-0
—AlXyl (C3H7 - C7H9) ester P027
—ftmyl ester F027 120-39-8
—Butoxyethoxypropyl ester P027 1928-58-1
—2-Butoxyethyl ester P027 2545-59-7
—Butoxypropyl ester P027 1928-48-9
—Butyl ester F027 93-79-8
—Dipropylene glycol isobutyl P027 53535-31-2
ether ester
~2-Ethylhexyl ester P027 1928-47-8
—Isobutyl ester P027 4938-72-1
-------
PEST/DIS-5
—Isoprqpyl ester P027 93-78-7
—Prcpylene glycol isobutyl F027 53466-86-7
ether ester
—Tripropylene glycol isobutyl P027 53535-32-3
ether ester
4-(2,4,5-Tri<±ilorcphenoxy)butyric F027 93-80-1
acid [2,4,5-TB]
2-(2,4,5-Tridilorophenoxy)ethyl P027 69633-04-1
hydrogen sulfate [2,4,5-TES]
l,41,5l-Trichloro-21-(2,4l5- F027 69462-14-2
trichlorophenoxy)
methanesulfonanilide [Edolan U]
J
-------
PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST (with
[40 CFR 261.33(f)]
Acetone
Acryloni tri 1 e*
Amitrole
Benzene*
Bis ( 2-ethylhexyl ) phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
( chloroacetaldehyde )
Chlordane, technical*
Chlorobenzene*
4-ChlortMn-cresol
Chloroform*
o-Chlorophenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorooctahydro-1 , 3 , 4-metheno-
2H-cycl6buta[c,d]-pentalen-2-one
(Kepone, chlordecone)
1 , 2-DibronD-3-chlorcpropane ( DBCP )
Dibutyl phthalate
S-2 , 3- ( Dichloroa 1 ly 1 di isopropy 1-
thiocarbanate) (diallate,Avadex)
o-Dichlorobenzene*
p-Dichlorobenzene*
Dichlorodifluorcnethane
(Freon 12®)
3 , 5-Dichloro-N- ( 1 , l-dimethyl-2-
propynyl) benzamide
(pronamide, Kerb*)
Dichloro diphenyl dichloroethane
(DDD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2 , 4-Dichlorophenoxyaceti c ,
salts and esters (2,4-D)*
1 , 2-Dichloropropane
1,3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
( l-chloro-2, 3-epoxypropane )
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate
(chlorobenzilate)
RCRA ft,
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 t
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
-------
PEST/DIS-7
Ethylene dibrcanri.de (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexadilorobenzene*
Hexachlorocyclooentadiene
Hexa chloroethane*
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-Tetrachlorcphenol*
[acute waste per 261.31]
Thiram
Toluene*
1,1,1-Trichloroethane*
(methyl chloroform)
Trichloroethylene*
Trichlororcnofluoromethane
(Freon 11«)
2,4,5-Trichlorophenol*
[acute waste per 261.31]
2,4,6-Trichlorophenol*
[acute waste per 261.31]
U067
U077
U1.15
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
-------
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
-------
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
reused1, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
£/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
107
-------
Consumer Information Sheet
INORGANIC ARSENICAL
PRESSURE-TREATED WOOD
(Including: CCA, ACA. and ACZA)
CONSUMER INFORMATION
This wood has been preserved by pressure-treatment
with an EPA-registcred pesticide containing inorganic
arsenic to protect it from insect attack and decay Wood
treated with inorganic arsenic should be used only where-
such protection is important
Inorganic arsenic penetrates deeply into and remains
in the pressure-treated wood for a long time Exposure to
inorganic arsenic may present certain hazards There-
fore, the following precautions should he taken both
when handling the treated wood and in determining
where to use or dispose of the treated wood
USE SITE PRECAUTIONS
Wood pressure-treated with waterborne arsenical pre-
servatives may be used inside residences as long as all
sawdust and construction debris are cleaned up and
disposed of after construction
Do not use treated wood under circumstances where
the preservative may become a component of food or
animal feed. Examples of such sites would be structures
or containers for storing silage or food.
Do not use treated wood for cutting-boards or counter-
tops.
Only treated wood that is visibly clean and free of
surface residue should be used for patios, decks and
walkways.
Do not use treated wood for construction of those
portions of beehix-es which may come into contact with
the honev.
Treated wood should not be used when- it ma\ come
into direct or indirect contact with public drinking water.
except for uses involving incidental contact such as
docks and bridges
HANDLING PRECAUTIONS
Dispose of treated wood by ordinary trash collection
or burial. Treated wood should not be burned in open
fires or in stows, fireplaces, or residential boilers because
toxic chemicals may be produced as part of the smoke
and ashes. Treated wood from commercial or industrial
use (e.g.. construction sites) may be burned only in
commercial or industrial incinerators or boilers in accor-
dance with state and Federal regulations.
Avoid frequent or prolonged inhalation of sawdust
from treated wood. When sawing and machining treated
wood, wear a dust mask. Whenever possible, these opera-
tions should be performed outdoors to avoid indoor
accumulations of airborne sawdust from treated wood.
When power-sawing and machining, wear goggles to
protect eyes from flying particles.
After working with the wood, and before eating, drink-
ing, and use of tobacco products, wash exposed areas
thoroughly.
If preservatives or sawdust accumulate on clothes.
launder before reuse. Wash work clothes separately from
other household clothing
Approtwi by the U.S. Environmental frotection Agency
15-997343
-------
III. USE INDEX APPENDIX
-------
EPA Compendium of Acceptable Uses
c 006801 ARSENIC ACID*
TYPE PESTICIDE; Fungicide (Refer also to Deslccant entry)
FORMULATIONS:
FI (75X)
SC/L (37,, 211)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE FESTICIDE. Individuals
who enter pressure treataent cylinders and other related equipment that
are contaminated with the wood treatment solution (e.g., cylinders that
are in operation or are not free of the treataent solution) Bust wear pro-
tective clothing, Including overalls, jacket, gloves, and boots, impervi-
ous to the wood treatment formulation. In addition, individuals who enter
pressure-treatment cylinders must vear properly fitting, veil-maintained,
high efficiency filter respirators, MSHA/NIOSH-approved for inorganic ar-
senic, if the level of inorganic arsenic in the plant is unknown or ex-
ceeds 10 micrograms per cubic meter of air (10ug/m3) averaged over an 8-
hour work period. Protective clothing must be changed when it shows signs
of contamination. Applicators must leave protective clothing and work-
shoes or boots and equipment at the plant. Worn-out protective clothing
and workshoes or boots must be left at the plant and disposed of in a man-
ner approved for pesticide disposal and in accordance with state and fed-
eral regulations. Alternatively, to potentially relieve employees from
the burden of wearing respirators, the employer may implement a Permissi-
ble Exposure Limit (PEL) Monitoring Program. Refer to appropriate label-
ing for details of the PEL Monitoring Program. Examples of acceptable
materials for protective clothing (e.g., gloves, overalls, jacket, and
boots) required during application and handling of Inorganic araenicals
are vinyl, polyvlnyl chloride (PVC), neoprene, NBR (Buna-H), rubber, and
polyethylene.
Definition of Terns;
w/v - weight to weight
*orthoarsenic acid
Issued: 5-27-86 II-006801-1
Provisional Update: 8-22-86
I 10
-------
EPA Compendium of Acceptable Uses
ARSENIC ACID
Site and Pest Dosages and Tolerance, Use, Limitations
Fomulation(s)
IKDOOR
(Wood or Wood Structure Protection Treatments)
/64Q100A Wood Protection Treatment to Forest
Products by Pressure
FYAEQBB Wood rot/decay [MAI] Vacuum-pressure impregnation. Di-
0.0002-0.0024 iute with water to concentrations
Ib a.i./ of 0.5 percent (w/w) to 0.8 percent
application (w/w) depending on retention desir-
(3Z SC/L) ed. Kiln dry after treatment or
allow 1 week between Impregnation
and Installation for fixation of
preservative.
Formulated with copper sulfate and
•odium dichromate.
Vacuum-pressure impregnation. Di-
0.0011-0.0168 iute with water to concentrations
Ib a.i./ of 0.5 percent (w/w) to 8 percent
application (w/w) depending on retention desir—
(21? SC/L) ed. Kiln dry after treatment or
allow 1 week between Impregnation
and installation for fixation of
preservative.
Formulated with chromic acid and
cupric oxide.
Issued: 5-27-86 II-006801-2
III
-------
EPA Compendium of Acceptable Uses
ARSENIC ACID
Listing of Registered Pesticide Products by Formulation
4075.0002 751 formulation intermediate
arsenic acid (006801)
000061-00171 003098-00016
4203.0015 3% soluble concentrate/liquid
arsenic acid (006801), copper sulfate (024401) plus sodium dichrornate
(068304)
045968-00004
4221.0015 211 soluble concentrate/liquid
arsenic acid (006801), chromic acid (021101) plus cuprlc oxide (042401)
045968-00005
Issued: 5-27-86 11-006801-3
I(3L
-------
EPA Compendium of Acceptable Uses
ARSENIC ACID
Appendix A-l
Listing of Active Ingredlent(s) Found in Combination With the Report Chemical
Chemical Common Name EPA Acceptable
Code (source) Common/Chemical Name
021101 — chromic acid
024401 — copper sulfate
042401 — cupric oxide
068304 — sodium dichromate
— Use EPA Acceptable Common/Chemical Name
Issued: 5-27-86 II-006801-4
-------
EPA Compendium of Acceptable Uses
c013601 " AMMONIUM ARSENATE
TYPE PESTICIDE; Insecticide, Fungicide
FORMULATIONS; RTU (7.77.)
GENERAL WARNINGS A!TD LIMITATIONS: None.
Site and Pest Dosages and Tolerance, Use, Limitations
Forraulation(s)
INDOOR
(Wood or Wood Structure Protection Treatments)
/640030A Wood Protection Treatment
(exposed surfaces of pressure Applicators must wear gloves (e.g.,
treated lumber) rubber, vinyl or neoprene) impervi-
ous to the wood treatment solution
in all situations where dermal con-
tact is expected (e.g., during the
application process and handling
freshly treated wood).
Applicators must wear disposable
coveralls (e.g., vinyl or polyethyl-
ene) or other similar impermeable
clothing during the application
process where dermal contact is ex-
pected.
IMGAAAA Termites . 7.77, solution Commercial or Industrial use only.
FYAEQBB Wood rot/decay (7.77, RTU) Wood protection treatment to exposed
surfaces of pressure treated lumber.
Stir contents and use full strength.
Apply several coats with brush or
rag mop to all surfaces of pressure
treated lumber that have been ex-
posed by cutting, notching or dap-
ping.
Formulated with copper (in the form
of an ammonia complex).
Issued: 3-08-85 III-013601-1
Provisional Update: 8-25-86
-------
EPA Compendium of Acceptable Uses
AMMONIUM ARSENATE
Listing of Registered Pesticide Products by Formulation
^207.7016 7.72 liquid-ready to use
ammonium arsenate (013601) plus copper (in the form of an ammonia
complex) (022702)
003098-00003 011351r00001*
*currently unavailable for review
Issued: 3-08-85 III-013601-2
US"
-------
EPA Compendium of Acceptable Uses
c006802 - ARSENIC PENTOXIDE
TYPE PESTICIDE; Insecticide, Fungicide, Molluscicide
FORMULATIONS;
SC/S (10%, 26.92, 30.5*)
SC/L (7.3%, 8.2%, 9.84%, 9.9*, 16.6%, 16.88%, 17*. 17.6%, 18%, 18.04%,
18.2%, 19%, 20.25%, 23.8%, 24.48%v 24.5%, 32.5%, 34%)
RTU (4.08%)
GENERAL WARNINGS AND LIMITATIONS: None.
Site and Pest
INDOOR
Dosages and Tolerance, Use, Limitations
Formulation(s)
(Wood or Wood Structure Protection Treatment)
/640030A
Wood Protection Treatment of
Pressure Treated Wood that has
been Exposed through Fabrication
or Damage
IMGAAAA
FYAEQB3
Termites.
Wood rot/decay
4.08% solu-
tion
(4.08% RTU)
Applicators must wear gloves (e.g.,
rubber, vinyl or neoprene) impervi-
ous to the wood treatment solution
in all situations where dermal con-
tact is expected (e.g., during the
application process and handling
freshly treated wood).
Applicators must wear disposable
coveralls (e.g., vinyl or polyethyl-
ene) or other similar impermeable
clothing during the application
process where dermal contact is ex-
pected.
Commercial or industrial use only.
Wood protection treatment to pres-
sure treated wood. Brush into all
cut or machined surfaces and allow
to soak into the wood.
Formulated with chromic acid, cupric
oxide.
Issued: 3-08-85
Provisional Update: 8-25-86
III-006802-1
-------
EPA Compendium of Acceptable Uses
ARSENIC PENTOXIDE
Site and Pest Dosages and Tolerance, Use, Limitations
Fonnulation(s)
/640100A Wood Protection Treatment by , RESTRICTED USE PESTICIDE.
Pressure (forest products) For sale to and use only by certi-
fied applicators or by persons under
their direct supervision and only
for those uses covered by the certi-
fied applicators' certification.
Applicators must wear gloves imper-
vious to the wood treatment formula-
tion in all situations where dermal
contact is expected (e.g., handling
freshly treated wood and manually
opening cylinder doors).
Individuals who enter pressure
treatment cylinders and other relat-
ed equipment that is contaminated
with the wood treatment solution
(e.g., cylinders that are in opera-
tion or are not free of the treat-
ment solution) must wear protective
clothing, including overalls, Jack-
et, gloves, and boots, Impervious
to the wood treatment formulation.
In addition, individuals who enter
pressure-treatment cylinders must
wear properly fitting, well-main-
cained, high efficiency filter res-
pirators, MSHA/NIOSH-approved for
inorganic arsenic, if the level of
inorganic arsenic in the plant is
unknown or exceeds 10 micrograms per
cubic meter of air (10ug/m3) averag-
ed over an 8-hour work period.
Protective clothing must be changed
when it shows signs of contamina-
tion. Applicators must leave pro- •
tective clothing and workshoes or
boots and equipment at the plant.
Worn-out protective clothing and
workshoes or boots must be left at
the plant and disposed of in a man-
ner approved for pesticide disposal
and in accordance with state and
federal regulations.
Individuals in the work area of an
arsenical wood treatment plant must
wear properly fitting, well-main-
tained high efficiency filter res-
pirators, MSHA/NIOSH-approved for
inorganic arsenic, if the level of
inorganic arsenic in the plant is
Issued: 3-08-85 III-006802-2
-------
Site and Pest
EPA Compendium of Acceptable Uses
ARSENIC PENTOXIDE
Dosages and Tolerance, Use, Limitations
Formulation(s)
Wood Protection Treatment by Pressure (forest products) (continued)
unknown or exceeds 10 mlcrograms per
cubic meter of air (10ug/m3) averag-
ed over an 8-hour work period.
Alternatively, to potentially re-
lieve employees from the burden of
wearing respirators, the employer
may implement a Permissible Exposure
Limit (PEL) Monitoring Program.
Note to user - Examples of accepta-
ble materials for protective cloth-
ing (e.g., gloves, overalls, jacket,
and boots) required during applica-
tion and handling of inorganic ar-
senicals are vinyl, polyvinyl chlo-
ride (PVC), neoprene, NBR (Buna-N),
rubber, and polyethylene.
IMGAAAA
FYAEQBB
Termites
Wood rot/decay
IMGAAAA
FYAEQBB
Termites
Wood rot/decay
0.045-1.9%
solution
(102, 26.9%,
30. 57. SC/S)
(8.2-34%
SC/L)
Wood protection treatment by pres-
sure.
Formulated with one or a combination
of: chromic acid, copper sulfate,
cupric oxide, potassium dichromate,
sodium dichromate, and sodium pyro-
arsenate.
No dose giv- y00(j protection treatment by pres-
en; refer to sure.
instructions Formulated with chromic acid, and
by American cupric oxide.
Wood Preser-
vation Assn.
(8.27, 9.84X,
16.67.,
16.88%, 17%,
18%, 18.2%,
20.25%,
24.5%, 34%
SC/L)
0.073-0.585%
solution
(7.3% SC/L)
Issued: 3-08-85
III-006802-3
MY
-------
Site and Pest
EPA Compendium of Acceptable Uses
ARSENIC PENTOXIDE
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
/690190A Wood Protection Treatment to Wood
Intended for Use in the
Construction of Boats, Ships, and
Marine Structures
RESTRICTED USE PESTICIDE.
For sale to and use only by certi-
fied applicators or by persons under
their direct supervision and only
for those uses covered by the certi-
fied applicators' certification.
Applicators must wear gloves imper-
vious to the wood treatment formula-
tion in all situations where dermal
contact is expected (e.g., handling
freshly treated wood and manually
opening cylinder doors).
Individuals who enter pressure
treatment cylinders and other relat-
ed equipment that is contaminated
with the wood treatment solution
(e.g., cylinders that are in opera-
tion or are not free of the treat-
ment solution) must wear protective
clothing, including overalls, jack-
et, gloves, and boots, impervious
to the wood treatment formulation.
In addition, individuals who enter
pressure-treatment cylinders must
wear properly fitting, well-main-
tained, high efficiency filter res-
pirators, MSHA/NIOSH-approved for
inorganic arsenic, if the level of
inorganic arsenic in the plant is
unknown or exceeds 10 micrograms per
cubic meter of air (10ug/m3) averag-
ed over an 8-hour work period.
Protective clothing must be changed
when it shows signs of contamina-
tion. Applicators must leave pro- .
tective clothing and workshoes or
boots and equipment at the plant.
Worn-out protective clothing and
workshoes or boots must be left at
the plant and disposed of in a man-
ner approved for pesticide disposal
and in accordance with state and
federal regulations.
Individuals in the work area of an
arsenical wood treatment plant must
wear properly fitting, well-main-
tained high efficiency filter res-
pirators, MSHA/NIOSH-approved for
inorganic arsenic, if the level of
inorganic arsenic in the plant is
Issued: 3-08-85
III-006802-4
-------
Site and Pest
EPA Compendium of Acceptable Uses
ARSENIC PENTOXIDE
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
Wood Protection Treatment to Wood Intended for Use in the Construction
of Boats, Ships, and Marine Structures (continued)
unknown or exceeds 10 micrograms per
cubic meter of air (10ug/m3) averag-
ed over an 8-hour work period.
Alternatively, to potentially re-
lieve employees from the burden of
wearing respirators, the employer
may implement a Permissible Exposure
Limit (PEL) Monitoring Program.
Note to user - Examples of accepta-
ble materials for protective cloth-
ing (e.g., gloves, overalls, jacket,
and boots) required during applica-
tion and handling of inorganic ar-
senicals are vinyl, polyvinyl chlo-
ride (PVC), neoprene, NBR (Buna-N),
rubber, and polyethylene.
IFAAEA
CEAAGA
Limnoria
Teredos
0.073-0.585% Wood protection treatment by pres-
solution sure.
(7.37, SC/L) Formulated with chromic acid, and
cupric oxide.
Issued: 3-08-85
III-006802-5
-------
EPA Compendium of Acceptable Uses
ARSENIC PENTOXIDE
Listing of Registered Pesticide Products by Formulation
&010.0015 10% soluble concentrate/solid
arsenic pentoxide (006802), copper sulfate (024401) plus potassium di-
chloride (068302)
000061-00127
&026.9015 26.9Z soluble concentrate/solid
arsenic pentoxide (006802), copper sulfate (024401) plus sodium dichro-
mate (068304)
000061-00140
&030.5015 30.5% soluble concentrate/solid
arsenic pentoxide (006802), sodium pyroarsenate (013401), copper sulfate
(024401) plus sodium dichromate (068304)
000061-00139
&207.3015 7.3% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
003008-00042
&208.2015 8.2% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
047097-00001
&209.8415 9.84% soluble concentrate/liquid
arsenic pentoxide (006802), chronic acid (021101) plus cupric oxide
(042401)
047097-00002
&209.9015 9.9% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
010465-aOOll
&216.6015 16.6% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
035896-00002
&216.8815 16.88% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
047097-00003
&217.0015 172 soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
000061-00128 003008-00036 010356-00006 048706-00001
Issued: 3-08-85 III-006802-6
-------
EPA Compendium of Acceptable Uses
ARSENIC PENTOXIDE
Listing of Registered Pesticide Products by Formulation (continued)
&217.6015 17.6? soluble concentrate/liouid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
010465-00012
&218.0015 18% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
003008-00035
&218.0415 18.04% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
000061-00170
&218.2015 18.2% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
008333-00002
&219.0015 197, soluble concentrate /liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
010465-00010
&220.2515 20.25% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
047097-00004
&223.8015 23.8* soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
000061-r00141*
.- *Jacket currently unavailable for review
&224.4815 24.48% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
000061-00173
&224.5015 24.5% soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
003008-00017
4232.5015 32.52 soluble concentrate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
003008-00034*
*jacket currently unavailable for review
Issued: 3-08-85 III-006802-7
I a. a.
-------
EPA Compendium of Acceptable Uses
ARSENIC PENTOXIDE
Listing of Registered Pesticide Products by Formulation (continued)
&234.0015 347 soluble concent rate/liquid
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
003008-00016 008333-00001
&204.0816 4.08% liquid-ready to use
arsenic pentoxide (006802), chromic acid (021101) plus cupric oxide
(042401)
003008-00021
9999999 State Label Registration
HI Reg. No.
035053-05242 036019-03490
Issued: 3-08-85 III-006802-8
-------
EPA Coapendiun of Acceptable Uses
c013401 ' SODIUM PYROARSENATE
TYPE PESTICIDE; Insecticide, Fungicide
FORMULATIONS; SC/S (6.2%)
GENERAL WARNINGS AND LIMITATIONS; For industrial use only.
Site and Pest
INDOOR
Dosages and Tolerance, Use, Limitations
Formulatlon(s)
(Wopd or Wood Structure Protection Treatments)
/6A0100A Wood Protection Treatment by
Pressure (forest products)
RESTRICTED USE PESTICIDE.
For sale to and use only by certi-
fied applicators or by persons under
their direct supervision and only
for those uses covered by the certi-
fied applicators' certification.
Applicators Bust wear gloves imper-
vious to the wood treatment formula-
tion in all situations where dermal
contact is expected (e.g., handling
freshly treated wood and manually
opening cylinder doors).
Individuals who enter pressure
treatment cylinders and other relat-
ed equipment that is contaminated
with the wood treatment solution
(e.g., cylinders that are in opera-
tion or are not free of the treat-
ment solution) must wear protective
clothing, including overalls, jack-
et, gloves, and boots, impervious
to the wood treatment formulation.
In addition, individuals who enter
pressure-treatment cylinders must
wear properly fitting, well-main-
tained, high efficiency filter res-
pirators, MSHA/NIOSH-approved for
inorganic arsenic, if the level of
inorganic arsenic in the plant is
unknown or exceeds 10 micrograms per
cubic meter of air (10ug/m3) averag-
ed over an 8-hour work period.
Protective clothing must be changed
when it shows signs of contamina-
tion. Applicators must leave pro-
tective clothing and workshoes or
Issued: 3-08-85
Provisional Update: 8-25-86
III-013401-1
-------
EPA Cotapendium of Acceptable Uses
SODIUM PYROARSENATE
Site and Pest Dosages and Tolerance, Use, Limitations
Fonnulation(s)
Wood Protection Treatment by Pressure (forest products) (continued)
boots and equipment at the plant.
Worn-out protective clothing and
workshoes or boots must be left at
the plant and disposed of in a man-
ner approved for pesticide disposal
and in accordance with state and
federal regulations.
Individuals in the work area of an
arsenical wood treatment plant must
wear properly fitting, well-main-
tained high efficiency filter res-
pirators, MSHA/NIOSH-approved for
inorganic arsenic, if the level of
inorganic arsenic in the plant is
unknown or exceeds 10 micrograms per
cubic meter of air (10ug/m3) averag-
ed over an 8-hour work period.
Alternatively, to potentially re-
lieve employees from the burden of
wearing respirators, the employer
may implement a Permissible Exposure
Limit (PEL) Monitoring Program.
Note to user - Examples of accepta-
ble materials for protective cloth-
ing (e.g., gloves, overalls, jacket,
and boots) required during applica-
tion and handling of inorganic ar-
senicals are vinyl, polyvinyl chlo-
ride (PVC), neoprene, NBR (Buna-N),
rubber, and polyethylene.
A closed emptying and mixing system
must be used for all powder formula-
tions of the inorganic arsenicals.
A closed systems is defined as any
containment which prevents the re-
lease of subject chemicals into the
surrounding external environment,
except that the release of incident-
al amounts of chemical during equip-
ment loading and periodic clean-out
or maintenance operations shall not
be deemed a breach of containment.
IVGAAAA Termites 0.062-0.312 Wood protection treatment by pres-
FYAEQBB Wood rot/decay solution sure.
(6.2% SC/S) Formulated with arsenic pentoxide,
copper sulfate, and sodium
dichromate.
Issued: 3-08-85 III-013A01-2
-------
EPA Compendium of Acceptable Uses
SODIUM PYROARSENATE
Listing of Registered Pesticide Products by Formulation
&006.2015 6.2% soluble concentrate/solid
sodium pyroarsenate (013401), arsenic pentoxide (006802), copper sulfate
(024401) plus sodium dichromate (068304)
000061-00139 :
Issued: 3-08-85 III-013401-3
-------
EPA Compendium of Acceptable Uses
:0113505 ' SODIUM ARSENATE*
TYPE PESTICIDE: Insecticide, Fungicide
FORMULATIONS:
Tech (98%, 98.88*)
SC/S (23.8%, 23.9%)
RTU (1.4%)
GENERAL WARNINGS AND LIMITATIONS :
Agricultural Tolerances;
Grapes - 3.5 ppn
Site and Pest
INDOOR
Dosages and Tolerance, Use, Limitations
Foraulation(s)
(Wood or Wood Structure Protection Treatment)
/640100A Wood Protection Treatment by Pres-
sure (forest products)
*disodium arsenate
Issued: 3-08-85
Provisional Update: 8-25-86
RESTRICTED USE PESTICIDE.
For sale to and use only by certi-
fied applicators or by persons under
their direct supervision and only
for those uses covered by the certi-
fied applicators' certification.
Applicators must wear gloves imper-
vious to the wood treatment fon,_Ia-
tion in all situations where dermal
contact is expected (e.g., handling
freshly treated wood and manually
opening cylinder doors).
Individuals who enter pressure
treatment cylinders and other relat-
ed equipment that is contaminated
with the wood treatment solution
(e.g., cylinders that are in opera-
tion or are not free of the treat-
ment solution) must wear protective
clothing, Including overalls, jack-
et, gloves, and boots, impervious
to the wood treatment formulation.
In addition, Individuals who enter
pressure-treatment cylinders must
wear properly fitting, well-main-
tained, high efficiency filter res-
pirators, MSHA/NIOSH-approved for
inorganic arsenic, if the level of
inorganic arsenic In the plant is
unknown or exceeds 10 micrograms per
111-013505-1
-------
EPA Compendium of Acceptable Uses
SODIUM ARSENATE
Site and Pest Dosages and Tolerance, Use, Limitations
Fotmulation(s)
Wood Protection Treatment by Pressure (forest products) (continued)
cubic meter of air (10ug/m3) averag-
ed over an 8-hour work period.
Protective clothing oust be changed
when it shows signs of contamina-
tion. Applicators must leave pro-
tective clothing and workshoes or
boots and equipment at the plant.
Worn-out protective clothing and
workshoes or boots must be left at
the plant and disposed of in a man-
ner approved for pesticide disposal
and in accordance with state and
federal regulations.
Individuals in the work area of an
arsenical wood treatment plant must
wear properly fitting, well-main-
tained high efficiency filter res-
pirators, MSHA/NIOSH-approved for
inorganic arsenic, if the level of
inorganic arsenic In the plant is
unknown or exceeds 10 micrograms per
cubic meter of air (10ug/m3) averag-
ed over an 8-hour work period.
Alternatively, to potentially re-
lieve employees from the burden of
wearing respirators, the employer
may implement a Permissible Exposure
Limit (PEL) Monitoring Program.
Note to user - Examples of accepta-
ble materials for protective cloth-
ing (e.g., gloves, overalls, jacket,
and boots) required during applica-
tion and handling of inorganic ar-
senlcals are vinyl, polyvinyl chlo-
ride (PVC), neoprene, NBR (Buna-N),
rubber, and polyethylene.
A closed emptying and mixing system
must be used for all powder formula-
tions of the inorganic arsenicals.
A closed systems is defined as any
containment which prevents the re-
lease of subject chemicals into the
surrounding external environment,
except that the release of incident-
al amounts of chemical during equip-
ment loading and periodic clean-out
or maintenance operations shall not
be deemed a breach of containment.
Issued: 3-08-85 111-013505-2
-------
Site and Pest
EPA Compendium of Acceptable Uses
SODIUM ARSENATE
Dosages and Tolerance, Use, Limitations
Foraulation(s)
Wood Protection Treatment by Pressure (forest products) (continued)
IMGAAAA
FYAEQBB
Termites
Wood rot/decay
0.119-1.19Z Wood protection treatment by pres-
solution sure. Use only in vacuum pressure
(23.8% SC/S) Impregnation of forest products.
Formulated with sodium pentachloro-
phenate, sodium chromate and sodlua
fluoride.
0.239-1.195Z Wood protection treatment by pres-
solution sure.
(23.92 SC/S) Formulated with 2,4-dinitrophenol,
sodium chromate and sodium fluo-
ride.
'640020A
Wood Protection Treatment of Sea-
soned Forest Products
'GAAAA
AEQBB
Termites
Wood rot/decav
(1.4% RTU)
Applicators must wear gloves (e.g.,
rubber, vinyl or neoprene) impervi-
ous to the wood treatment solution
in all situations where dermal con-
tact is expected (e.g., during the
application process and handling
freshly treated wood).
Applicators must wear disposable
coveralls (e.g., vinyl or polyethyl-
ene) or other similar impermeable
clothing during the application
process where dermal contact is ex-
pected.
Commercial or industrial use only.
Wood protection treatoent of season-
ed forest products. Use only for
application to exposed surfaces when
cutting, notching or dapping pres-
sure treated lumber. Apply several
coats undiluted with brush or rag
mop to all surfaces of lumber that
have been exposed by cutting, notch-
ing or dapping.
Formulated with 2,4-dinitrophenol,
sodium chromate, pyridlne and
sodium fluoride.
Issued: 3-08-85
III-013505-3
-------
EPA Compendium of Acceptable Uses
SODIUM ARSENATE
Site and Pest Dosages and Tolerance, Use, Limitations
Fonnulation(s)
/640010A Wood Protection Treatment of Unsea-
soned Forest Products
IMGAAAA Termites — Wood protection treatment of unsea-
FTAEQBB Wood rot/decay (23.9% SC/S) soned forest products. Use as a
diffusion treatment In water solu-
tions having hydrometer readings
from 1.13 to 1.37.
Formulated with 2,4-dinltrophenol,
sodium chromate and sodium fluo-
ride.
Issued: 3-08-85 III-013505-A
I 30
-------
EPA Compendium of Acceptable Uses
: SODIUM ARSENATE
Listing of Registered Pesticide Products by Formulation
i 098.0001 98% technical chemical
sodium arsenate (013505)
015135-00001
•098.8801 98.88% technical chemical
sodium arsenate (013505)
003008-00029
.023.8015 23.8% soluble concentrate/solid
sodium arsenate (013505), sodium pentachlorophenate (063003), sodium
chrornate (068303) plus sodium fluoride (075202)
000061-00124
023.9015 23.9Z soluble concentrate/solid
sodium arsenate (013505), 2,4-dinitrophenol (037509), sodium chrornate
(068303) plus sodium fluoride (075202)
000061-00110 000061-00134
201.4016 1.4% liquid-ready to use
sodium arsenate (013505), 2,4-dinitrophenol (037509), sodium chromate
(068303), pyridine (069202) plus sodium fluoride (075202)
000061-00111
999999 State Label Registration
HI Reg. No.
035053-05213
Issued: 3-08-85 111-013505-5
131
-------
EPA Compendium of Acceptable Uses
007001 ARSENIC TRIOXIDE*
TYPE PESTICIDE; Antifoulant, Herbicide, Insecticide, Rodenticide
FOR?fULATIONS;
Tech (907., 9AZ, 992, 99.57)
FI (37%, 99%)
WP (20%)
GENERAL WARNINGS AND LIMITATIONS: None.
Tolerance, Use, Limitations
640020A
MGAAAA
Site, Dosage
and Formulation
DOMESTIC OUTDOOR
(Wood or Wood Structure Protection Treatment)
Wood Poles
Termites
2 Ib a.i./gal
(20% WP)
Impregnation treatment. Mix product with water
to form a smooth paste. Vertical punctures should
be made at A inch intervals. Inject all the paste
contained in the piston sheath into the punctures.
Formulated with 2,4-dinitrophenol and sodium fluo-
ride.
*arsenous oxide
Issued: 3-08-85
Provisional Update:
1-007001-1
8-25-86
-------
EPA Compendium of Acceptable Uses
ARSENIC TRIOXIDE
Listing of Registered Pesticide Products by Formulation
&090.0001 90% technical chemical
arsenic trioxide (007001)
009777-00001
&094.0001 94% technical chemical
arsenic trioxide (007001)
003840-00005 004581-00259
i099.0001 99% technical chemical
arsenic trioxide (007001)
001439-00189
4099.5001 99.5* technical chemical
arsenic trioxide (007001)
007401-00202
i037.0002 377 formulation intermediate
arsenic trioxide (007001) plus copper (metallic) (022501)
003098-00015
i099.0002 992 formulation intermediate
arsenic trioxide (007001)
000255-00025
006 20% wettable powder
arsenic trioxide (0070C1), 2,4-dinitrophenol (037509) plus sodium fluo-
ride (075202)
003231-00001
Issued: 3-08-85 1-007001-2
13?
-------
IV. BIBLIOGRAPHY APPENDICES
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
s'.ould 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.
-------
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.
3(r
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chromated and Non-Chromated
Arsenical Wood Preservatives Standard
HRID CITATION
00099363 Fink, R.; Reno, F.E. (1973) Final Report: Acute LC50--Bluegill
Sunfish and Rainbow Trout: Taco CCA, 40% Concentrate: Projects
No. 829-100 and No. 829-101. (Unpublished study received Aug
20, 1973 under 8333-1; prepared by Environmental Sciences Corp.,
submitted by Rentokll, Inc., Spartanburg, N.C.; CDL:128552-B)
00104601 Wolven, A.; Levenstein, I. (1970) To Determine If the Test Materi-
al Produces Any Irritation When Instilled Into Rabbits' Eyes:
Assay No. 10100. (Unpublished study received Oct 27, 1970
under 390-43; prepared by Leberco Laboratories, submitted by
Pettit Paint Co., Inc., Borough of Rockaway. NJ; CDL:003224-B)
00106113 Fink, R. (1973) Final Report: Eight-day Dietary LC50--Bobwhite
Quail: Taco CCA: Project No. 829-102. (Unpublished study
received Aug 20, 1973 under 8333-1; prepared by Environmental
Sciences Corp., submitted by Rentokil, Inc., Spartanburg, N.C.;
CDLU28552-C)
00120843 Peoples, S. (1979) The Dermal Absorption of Arsenic in Dogs from
Sawdust from Wood Treated with ACA and CCA-C. (Unpublished
study received Aug 27, 1979 under unknown admin, no.; prepared
by Univ. of California—Davis, Dept. of Physiological Science,
submitted by Koppers Co., Inc., Pittsburgh, PA; CDL:240889-B)
00159870 Jacobson-Kram, D.; Mushak, P.; Piscator, M.; et al. (1984) Health
Assessment Document for Inorganic Arsenic: Final Report: EPA-
'' 600/8-83-021F. Washington, DC: Environmental Protection Agency.
347 p.
GS0647-001 Woolson, E.; Gjovlk, L. (1981) The Valence State of Arsenic on
Treated Wood. American Wood-Preservers' Association [Proceedings
of 1981 Annual Meeting]. 5 p.
GS0647-002 US Environmental Protection Agency (1984) Health Assessment Document
for Chromium: Final Report: EPA-600/8-83-014F. 180 p.
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V. FORMS APPENDICES
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OMB Approval No. 2000-0468 (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 the FIFRA section 3(0(21(6) notice contained in the referenced
Guidance Document, I am responding in the following manner:
D 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
!. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
Lj 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
•
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-82)
-------
OMB Approval No. 2000-0468 (Expires:
\o qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. 1 am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMP AN Y N UMB b K ,
1
!
1
(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 I
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 tc b;
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(j) on the following dated):
I
NAME OF FIRM
DATE OF OFFER |
I
t
i
1
1
t
1
1
However, none of those firm(s) accepted my offer. i
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 the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not appiy to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8580-6 (10-82)
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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
Citino MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
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
Flanrnability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dental
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary denial
irritation
Dental sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am conplying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Nunibers
Assigned
-------
FORVJLATOR'S EXEMPTION' STATEMENT
(40 CFR 152.R5)
EPA File Symbol/fteg. No. Product Name
Applicant's' None-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 from another
producer.
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
name, the source of the active ingredient(s) listed in paragraph (1).
OR
(-B) The Confidential Statement of Formula dated on file with
the EPA is complete, current and accurate and contains the information
required on the current CSF Form No. 8570-4. The registered source(s)
of the active ingredient(s) listed in paragraph (1) is/are listed below:
Active ingredient Source; Product name and Reg. No.
Signature
Date Title
EPA Form (April 1985) ' " *
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