4>EPA
EmrironiiMmai Protection
Officaof
Toxic
2O4M
540-RS-88-066
Guidance for the
Reregistration of
Pesticide Products
Containing
COAL TAR/CREOSOTE
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
COAL TAR/CREOSOTE
AS THE ACTIVE INGREDIENT
EPA NUMBER 128935
CASE NUMBERS 639 AND 137
APRIL 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
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TABLE OF CONTENT
I. Introduction
II. Chemical(s) Covered by this Standard
A. Description of Chemicals
B. Use Profile
C. History of Use
D. Regulatory History
III. Agency Assessment 4
A. Preliminary Risk Assessment
IV. Regulatory Position and Rationale 11
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 25
VI. Requirement for Submission of Generic Data 27
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. Testing protocols, test standards and guidance
F. Procedures for requesting a change in protocol
G. Procedures for requesting extensions of time
H. PR Notice 86-5 and any other requirements
referenced or included within this Notice
I. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 33
VIII. Requirement for Submission of Revised Labeling 34
IX. Instructions for Submission 34
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate products
F. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. FEASIBILITY STUDY FORMAT
Attachment II - Creosote wood treatment plants
Attachment III - Sawmills and planing plants
III. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Container Disposal Instructions
Attachment IV-1 - AWPA Standards for coal tar/creosote
IV. USE INDEX APPENDIX
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
VI. BIBLIOGRAPHY APPENDIX
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I. INTRODUCTION
EPA has established the Registration Standards program in
order to provide an orderly mechanism by which pesticide pro-
ducts containing the same active ingredient can be reviewed and
standards set for compliance with FIFRA. The standards are
applicable to reregistration and future applications for regis-
tration 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 dis-
tribute that product must bring his product and labeling into
compliance with FIFRA, as instructed by this Standard. Pesticides
have been grouped into use clusters and will be reviewed on the
basis of a ranking scheme giving higher priority to (1) pesticides
in clusters used on food and feed crops; and (2) pesticides pro-
duced in large volumes.
The Registration Standards program involves a thorough re-
view of the scientific data base underlying a pesticide's regis-
tration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of
the pesticide; to determine the need for additional data on
health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criteria
of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data require-
ments for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued regis
tration. The additional studies may not have been re-
quired 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 avail-
able data in its files pertaining to the pesticide coal tar/
creosote. However, during the review of these data the Agency
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M Street, SW. , Washington, D.C. 20460.
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is also looking for potential hazards that may be associated
with the end use products that contain the active ingredient.
The Agency will apply the provisions of this Registration
Standard to end use products if necessary,to protect man and
the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See Section
IV Regulatory Position and Rationale. Based on its regulatory
position, the Agency may prescribe a variety of steps to be
taken by registrants to maintain their registrations in com-
pliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the pest-
icide 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 environ-
ment are identified, the Agency may initiate a special review of
the pesticide in accordance with 40 CFR Part 154 to examine in
depth the risks and benefits of use of the pesticide. If the
Agency determines that the risks of the pesticide's use outweigh
the benefits of use, the Agency may propose additional regulatory
actions, such as cancellation of uses of the pesticide which
have been determined to cause unreasonable adverse effects on
the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit data
to answer Agency 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 its 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.
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Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreaso-
nable adverse effects of a pesticide at any time that they
become aware of such information. Registrants must notify the
Agency of any information, including interim or preliminary
results of studies, if that information suggests possible adverse
effects on man or the environment. This requirement is indepen-
dent of the specific time requirements imposed by EPA for sub-
mission of completed studies called in by the Agency and continues
as long as the products are registered under FIFRA.
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II. CHEMICALS COVERED BY THIS STANDARD
A. Description of Chemicals
Current definition of ingredients. This Registration Standard
covers coal tar/creosote products, including the following
currently named ingredients (with EPA identifying numbers):
ASPHALT (022001) COAL TAR NEUTRAL OIL (025001)
BITUMEN (022002) WOOD CREOSOTE (025002)
COAL TAR (022003) CREOSOTE OIL (025003)
TAR (022004) COAL TAR CREOSOTE (025004)
Redefinition of coal tar/creosote "ingredients." The ingredients
covered by this Registration Standard do not consist of single,
specific chemicals, as do other pesticide ingredients. The
names listed above are the ones traditionally used in the wood
preserving industry; industry trade associations have set stan-
dards for these "ingredients" defined by physical characteristics,
such as boiling point ranges and viscosity.
Because of the chemically complex mixture of materials in
coal tar/creosote (See Chemical Composition, page II-2) the
Agency will utilize eight standard products defined by the
American Wood Preservers Association(AWPA) for testing purposes.
The AWPA standards for these products are based upon physical
properties and percentages of material from specific distillation
ranges. Three of the AWPA standard products are coal tar dis-
tillate fractions designated as creosote (PI, P7, and P13) and
five are solutions of coal tar and creosote in varying propor-
tions (P2A, P2B, P2C, P2D, and P12). These products must conform
to AWPA specifications. Industry-wide composites of the eight
AWPA standard products will be developed by the registrants in
consultation with EPA. These composites will be maintained by
the registrants and will be utilized for all testing.
Manufacturing process. Coal tar and creosote are complex hetero-
geneous mixtures of chemicals derived from the fractional distil-
lation of coal or wood tar. The actual chemical reactions occurr-
ing in the distillation process are not well understood.
Coal tar is the major part of the liquid condensate obtained
from the "dry" distillation or carbonization of coal to coke.
Creosote is the low boiling distillate fractions of coal
tar/wood tar, and consists principally of liquid and solid aro-
matic hydrocarbons, with some tar acids and bases also present.
It is heavier than water and has a continuous boiling range from
about 200°C to about 450°C.
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Chemical composition. The chemical composition of the coal tar/
creosote distillate fractions is highly variable due to differ-
ences in the source and composition of raw materials (coal/wood)
and manufacturing variables (temperature., coking time, gas collec-
tion, coke oven systems, and the design and operating parameters
of the still).
Hundreds of individual chemicals have been identified in
coal tar/creosote, although many of these may be present only in
trace amounts. Lorenz and Gjovik (1972), and McNeil (1952) have
identified eight classes of compounds commonly found in creosote
and coal tar products. These are:
(1) Unsubstituted 6-membered rings
(2) Heterocyclic nitrogen bases
(3) Heterocyclic oxygen and sulfur compounds
(4) Alkyl substituted compounds
(5) Hydroxy compounds
(6) Aromatic amines
(7) Paraffins
(8) Naphthenes
Proportions of each of these classes can vary from batch to
batch, even within formulations developed for a particular
purpose.
B. Use Profile
Type of Pesticide
Pests Controlled
Registered Uses
Predominant Use
Method of Application
Mode of Activity
Formulations
MP and EP
Fungicide, insect (wood boring)
repellent, bacteriocide
Fungi, insects, bacteria, and
marine borers
Wood preservative
Wood preservation
Pressure treatment and non-pressure
treatment? brush-on, spray-on,
and dipping(soaking)
Prevention of fungus and bacterial
decay, insect repellent.
AWPA standard products(concentrates
or dilutions) may serve as MP's or
EP's.
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C. History of Use
Coal tar/creosote has been widely used as a wood preserving
agent since the early 1900's. In 1975 approximately 238 million
pounds of coal tar and 843 million pounds of creosote were
used in the U.S. The major producers in 1985 included Koppers,
Bethlehem Steel, Allied Chemical and Reilly Tar and Chemical
Company.
D. Regulatory His t or y
On October 18, 1978 (43 FR 48154), the Environmental Pro-
tection Agency initiated a Special Review [previously referred
to as the Rebuttable Presumption against Registration (RPAR)
Process] for wood preservative products containing creosote
based on information indicating risks of mutagenicity and
oncogenicity to humans. The Special Review was supported by
Position Document No. 1 (PD 1).
In the Preliminary Determination concluding the Special
Review, published on February 19, 1981 (46 FR 13020), the Agency
reaffirmed its risk concerns and on July 13, 1984 (49 FR 28666),
published a Notice of Intent to cancel the registration of wood
preservative products containing creosote, which required cer-
tain label modifications to coal tar/creosote wood preservative
products in order to avoid cancellation. Supporting documents
for these actions are Position Document No. 2/3 (PD 2/3), dated
January 1, 1981 and Position Document No. 4 (PD 4), dated July
13, 1984, respectively.
After considering alternative mechanisms suggested by
registrants who requested a hearing in response to the July 13,
1984, notice, the Agency published an amended notice of intent
to cancel registrations on January 10, 1986 (51 FR 1334). This
notice made minor modifications to the requirements of the ori-
ginal notice and resolved the issues relating to the wood
preservative use of coal tar/creosote.
In related actions published on October 16, 1985 (50 FR
41943), subject: "Intent to Cancel Registrations of Pesticide
Products Containing Creosote and Coal Tar For Non-wood Preserva-
tive Uses" (except those for control of gypsy moth egg masses),
and May 15, 1986, subject: "Notice to Registrants and Applicants
Affected by the Notice of Intent to Cancel Non-Wood Preservative
Creosote and Coal Tar Products", the Agency ultimately cancelled
the registrations of all non-wood preservative uses of coal
tar/creosote.
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III. AGENCY ASSESSMENT
As part of the Special Review, the Agency has reviewed all
data submitted to support the registration of coal tar/ creosote
and the extensive body of data in the literature. These data/
for the most part, were developed from specific formulations of
coal tar, creosote and coal tar neutral oils as well as various
unidentified formulations of these products. Because the indivi-
dual constituents of these formulations are not identified, all
available data are considered inadequate or invalid. However,
evidence of potential environmental and human health risks from
the formulations and their chemical constituents is substantial
and is discussed in detail in PD 2/3 and PD 4. Complete biblio-
graphic information on the sources cited in this Registration
Standard may be found in the bibliography to PD 2/3 and PD 4.
A. PRELIMINARY RISK ASSESSMENT
1. Oncogenicity of coal tar/creosote. Based on qualitative eval-
uations, the Agency has concluded that exposure to coal tar/creo-
sote formulations poses an oncogenic risk.
Two hundred years ago, scrotal cancer was observed in
English chimney sweeps (Pott, 1775). Since that time, reports
have confirmed cases of cancer in humans resulting from industrial
exposure to coal tars (NIOSH, 1977). Shambaugh (1935) reported
that fishermen who held tar-soaked needles in their mouths while
mending tarred nets, developed lip cancer.
Substantial epidemiological evidence is available to show
that exposure to coke oven emissions, which condense to form coal
tars, gives rise in workers to an excess risk of death from lung
cancer and cancers of the bladder, prostate, pancreas, and large
intestine (CAG, 1978a).
In an analysis of a study of wood treatment plant workers
(Tabershaw, 1979), significant increases in benign growths and
pseudofolliculitis in the study population were observed. These
eruptions occurred where clothing rubbed against the skin rather
than in areas exposed to the sun, suggesting that the effects
were caused by exposure to the creosote preservative through the
clothing.
Even though no valid epidemiology studies of workers using
creosote or coal tar formulations (CAG, 1977, 1982) have been
performed, creosote and coal tar and many of their component
chemicals have been well characterized as carcinogens in labora-
tory animals (PD-1, Coal Tar, Creosote, and Coal Tar Neutral
Oils; PD-2/3,4 Wood Preservatives and Non-Wood Uses; IRAC, 1973,
1983)- These studies, along with the several reports in the
literature of skin cancer in people exposed to creosote and A
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coal tars, suggest that these chemicals are human carcinogens.
A report by the Agency's Carcinogen Assessment Group (1977)
summarizes several mouse skin painting studies (Woodhouse,
1950; Poel and Kramer, 1957; Lijinsky et_ al., 1957; Boutwell
and Bosch, 1958) in which creosote was found to cause skin
papillomas and carcinomas. In one study (Roe et al., 1958),
lung adenomas as well as skin tumors were observed in mice re-
ceiving dermal applications of creosote oil.
The CAG report (1977) also summarizes numerous skin painting
studies in which coal tars produced skin cancer in mice and
rabbits. In addition, tumors of the lung were reported in mice
inhaling coal tar aerosols (Horton et al., 1963).
Berenblum and Schoental (1947) tested several coal tar neutral
oil fractions in mice and rabbits. Most fractions were found to
be oncogenic. In 1961, Horton showed that extracts (in maleic
anhydride) of coal tar neutral oils produced tumors in mice in
about 33 weeks.
A dermal oncogenicity study (mouse skin painting study) is re-
quired to enable the Agency to quantify risk.
2. Qncogenicity of coal tar/creosote constituents. A series of
aromatic amines,among them some monocyclic amines occurring in
creosote (Nestler, 1974), were tested for long-term toxicity by
dietary administration to Charles River rats and HaM/ICR mice
(Weisburger et al., 1978). Of these amines, ortho- and para-tolui-
dine, 2,4-xylTdine, and 2,5-xylidine caused tumors in various
tissues. The boiling points of these compounds range from 200°C
to 215°C.
Chrysene, one of the major components of creosote, is a 4-ring
polynuclear aromatic hydrocarbon (PAH) which boils at 448°C. As
reviewed by the I ARC (1973, 1983). chrysene causes skin tumors in
mice, and acts as an initiator of skin cancer in mice.
The carcinogenicity of many of these larger PAH's has been stu-
died and reviewed extensively (CAG, 1978b; IARC, 1973, 1983).
Known PAH carcinogens in coal tar are:
benz[a Janthracene benz[a jcarbazole
benzo[b]fluoranthene benzo[i]fluoranthene
benz[c]acridine benzo[ajpyrene
benzo[elpyrene chrysene
dibenzo[a,ilanthracene dibenz[a,h]anthracene
dibenzo[a,h] pyrene dibenzo[a,iIpyrene
indeno [1,2,3-cdIpyrene
A number of chemicals in creosote and coal tar also act as cocar-
cinogens, initiators, accelerating agents and inhibitors which
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may serve to influence tumorigenic responses in test animals.
3. Mutagenicity. Coal tar/creosote f©emulations elicit muta-
genic responses in microbial and mammalian species.
Creosote and coal tar/creosote have been shown to be muta-
genic in bacteria (Salmonella typhimurium) and mammalian cells in
vitro (L5178Y mouse lymphoma cells).In both test systems, the
complex mixtures caused point/gene mutations in a dose-dependent
manner in the presence of an exogenous hepatic metabolic activation
system. In the bacterial tests, positive responses were found pri-
marily in frameshift-sensitive tester strains. There are several
known mutagens identified in coal tar/creosote (e.g., certain
polycyclic aromatic hydrocarbons, aza-heterocyclic compounds, and
aromatic amines). In Salmonella, these chemicals are known to act
as frameshift mutagensthat require metabolic activation.
There is also suggestive evidence that creosote causes unsched-
uled DNA synthesis in cultured human lung fibroblast (WI-38) cells.
Creosote and coal tar/creosote did not cause genetic damage
in yeast tests for mitotic recombination, in Escherichia coli WP2
reverse mutation assays, and in differential growthinhibition
tests using repair proficient and repair-deficient strains of
Bacillus subtilis and IE. coli. However, because of the limitations
of these submammalian tests and because of inadequacies in the
studies conducted, the reported negative results are not judged
as evidence for the non-mutagenicity of coal tar/creosote.
Mutagenicity studies are required to further assess the
mutagenic potential of coal tar/creosote.
4. Teratogenicity. Data are not available to evaluate teratogenic
effects of coal tar/creosote. A teratogenicity study is required
to assess these effects.
5. Exposure. Inhalation exposure to creosote can occur in a
variety of ways. A discussion of treatment plant exposures
appears in the PD 2/3. Measured values of polycyclic particulate
organic matter in treatment plants, as well as confirmation of
specific constituents in the breathing zones of workers, confirm
that wood treatment results in inhalation exposure to creosote
and its constiuents. Because the Agency is concerned about the
chemicals in the breathing zone of workers in treatment plants,
EPA is requiring monitoring to identify and quantify the chemicals
to which workers are exposed.
6. Risk assessment. It is clear from the large number of labora-
tory studies on coal tar/creosote and its individual constituents
that they are animal carcinogens and mutagens. This finding,
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along with the fact that some finite, though presently unquanti-
ifiable, exposure to workers exists, gives rise to concerns re-
garding the risks to these workers.
The Agency is unable to perform a quantitative risk assess-
ment for coal tar/creosote of the type usually conducted for
oncogens. Since these products are complex mixtures with known
synergistic effects, a risk assessment which combines an animal
study potency value (Q*) based on any single carcinogenic consti-
tuent with an exposure value is not suitable.
An epidemiological study would be the best method to evaluate
and quantitate the cancer risk associated with exposure to coal
tar/creosote. The epidemiological study cited earlier (CAG,
1978a) for coke oven workers has limited usefulness because of
variable conditions and degrees of exposure that may exist in the
workplace. For example, coke ovens operate at high temperatures,
leading to worker exposure to higher boiling point fractions of
coal tar than is normally the case with wood treatment plant
workers. All other available epidemiological studies have been
judged inadequate for quantitative risk assessment purposes.
The Agency is requiring a study to determine whether it is
feasible to design a suitable epidemiological study (See item 7,
Part IV. Regulatory Position and Rationale).
B. OTHER SCIENCE FINDINGS
1. Acute toxicity. Coal tar/creosote formulations are currently
categorized as corrosive or highly irritating to the eye (Toxicity
Category I), but only moderate toxicity by systemic routes of
exposure (Toxicity Category III). Skin exposure has been reported
to result in burns, irritation, and sensitization among workers.
Acute toxicity studies are required to verify these acute hazards.
2. Fish and wildlife toxicity. Laboratory bioassays indicate
that coal tar products are moderately to highly toxic to aquatic
organisms. Because the amount and type of exposure in the field
is unknown, it is not possible to estimate hazard to aquatic
organisms. Other than the laboratory studies, there is no evidence
to date of environmental hazards to aquatic organisms (including
endangered species) from its use in treating wood used in aquatic
sites. Studies using composite test materials(CTM's) of AWPA
standard products typically included in formulation for terrestrial
and aquatic uses are required, and if toxicity is established,
similar studies will be required involving exposure to wood that
has been treated with these formulations.
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C. TOLERANCE ASSESSMENT
There are no products registered that allow for direct food
or feed uses of coal tar/creosote; therefore EPA has not estab-
blished tolerances or exemptions from tolerances in raw agri-
cultural commodities or processed food and feed products under
the Federal Food, Drug and Cosmetic Act (FFDCA),
Label restrictions prohibit the use of coal tar or creosote
products registered for farm and home use to treat wood intended
to be used in a manner in which the preservative may become a
component of food or feed. A similar statement appears as a re-
commendation regarding use of creosote-treated wood in a consumer
information sheet which is the focus of a voluntary industry
Consumer Information Program.
D. CHEMICALS TO BE TESTED
Because of the heterogeneous and variable composition of
coal tar/creosote, it is not practical for EPA to use the approach
to data generation followed with individual chemical ingredients.
This section describes the test types and test substances to be
used in developing data on coal tar/creosote. Details on the
test protocols can be found in the Pesticide Assessment Guide-
lines, and in the footnotes to Table A of Appendix I.
1. Standardized products as active ingredients. The initial
step in defining appropriate test materials is to define the
"active ingredients". For the purpose of this registration stan-
dard, the eight standard products defined by criteria established
by the AWPA are active ingredients. The criteria consist of
physical properties and percentages of specified distillate
fractions (Refer to Section II)
Each of these active ingredients is not a single chemical in
the traditional sense of the term. Each standard product is a
complex mixture that may vary in chemical composition depending on
the source materials and the production process. The composition
of any one standard product may vary among producers and may vary
between batches from a single producer.
Each registrant of a pesticide product containing coal
tar/creosote will be required to certify the composition of his
product in terms of the presence and quantity of each distillate
fraction defined by the Agency. Product labels will also
have to be changed to reflect the new names and percentages.
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2. Composite Test Material for Toxicology Testing. For each
AWPA specification registrants are required to produce a "Compo-
site Test Material" (CTM) that will be used in the majority of
toxicology tests. There will be eight CTMs, one for each AWPA
standard.
A CTM is an appropriate test substance because it will be
derived from production lots over time and from varying processes
and facilities. Tests conducted with the CTM will therefore be
representative of exposures likely to occur during the production
processes used, and will yield results and show effects which are
most likely to be seen in chronic exposures. In addition, because
coal tar/creosote products may vary from batch to batch, it is
possible that use of test substance from one batch would yield
positive results, while a second batch would yield negative re-
sults .
Registrants have two options in selecting an appropriate
CTM:
a. EPA's preferred option is that registrants of coal tar/
creosote collectively develop a set of CTMs. Each such CTM
should be representative of the typical AWPA standard produced by
the registrants over time and from differing production processes
and facilities.
b. Alternatively, each registrant may develop a CTM for
each AWPA standard derived only from his own sources and processes.
EPA notes, however, that not only would it be very costly to in-
dividual registrants to conduct the required testing on an indivi-
dual basis, but the studies would yield data which, while highly
specific to a particular product, might be duplicative and might
not contribute optimally to an evaluation of coal tar/creosote
products in general.
A sufficient quantity of each CTM must be produced and main-
tained by registrants for both testing and future reference pur-
poses. Each of the eight CTMs must be completely analyzed to
identify and quantify each individual constituent present at or
above 0.5% of the CTM. Registrants will be required to certify
the composition of the CTM used for all tests.
Before beginning tests with any CTM, registrants must consult
with the Agency and obtain approval of the sampling protocol used
to produce the CTM.
3. Selection of test materials for environmental fate studies.
Guideline environmental fate studies are designed to investigate
the fate of specific chemicals. Performing these standard tests
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on the manufacturing use product composites is not practical
because of the extensive number of components in each composite.
Modifications in testing procedures may be warranted and, if so,
will be prescribed by the Agency in order to satisfy certain
environmental fate data requirements. Alternatively, individual
components or groups of compounds in the coal tar/creosote compo-
site may be selected for testing. Currently the Agency lacks
adequate product chemistry data to fully evaluate which testing
procedures/test materials are most appropriate for obtaining
environmental fate information. When pertinent chemistry data
required by this registration standard are available to the
Agency, guidance on testing procedures and appropriate test
materials will be provided to registrants.
4. Ecological effects testing. Ecological effects testing for
fish and wildlife toxicity are to be conducted using the CTMs
which meet AWPA Specifications for PI, P2C, and P13.
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PART IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS
Based on the review and evaluation of available data and
other relevant information on coal tar/creosote, the Agency has
made certain determinations relating to the protection of indus-
try workers, the public and the environment from hazards directly
attributable to the use of these pesticide products. The Agency's
amended Notice of January 10, 1986 (51 FR 1334) outlines the
Agency's regulatory position in detail.
1. Special Review. The Agency has conducted a Special Review of
coal tar/creosote products and concludes that the benefits of use
of these products outweigh the risks of use, if certain labeling
changes are made. As a result of the Special Review, the Agency
has imposed a number of protective measures to reduce exposure to
coal tar and creosote products and will continue these require-
ments. Among the requirements are labeling changes restricting
use to certified applicators and requiring certain protective
clothing and equipment for applicators. The labeling requirements
set forth in the January 10, 1986 Notice are detailed in Section
IV.D. of this Standard.
Rationale. Coal tar/creosote pesticides pose potential onco-
genic and mutagenic risks due to dermal and/or inhalation exposure.
Substantial protection from risks is provided through implementa-
tion and practice of certain requirements including protective
clothing and equipment, pesticide use restrictions, and applicator
certification. These provisions are discussed in detail in the
amended Notice and are also contained in Section IV.D. of this
Standard.
Protective clothing will reduce total dermal exposure by more
than 80%. Proper handling/cleaning/disposal of contaminated or
worn out protective clothing will reduce potential exposure and
risk to the worker and his family. Inhalation exposure to appli-
cators wearing effective and properly fitted respirators may be
reduced by more than 90%.
Improved industrial hygiene practices, including thorough
washing and prohibitions on eating, drinking and smoking during
application, will significantly reduce exposure and reduce the
inherent risks associated with coal tar/creosote.
A prohibition for the home and farm uses of coal tar/creo-
sote on wood intended for interior use, with certain exceptions,
will substantially reduce potential inhalation and dermal exposures
to the general public.
Restricted Use classification of coal tar/creosote pesticides
which permits sale to and use only by certified applicators or
it
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persons under their direct supervision will reduce opportunities
for misuse and thereby decrease exposure and potential risk.
2. Maintenance of Composite Test Material(CTM). The
Agency is requiring that a Composite Test Material for each of th<
AWPA standard products be developed by registrants and maintained
by a single organization, designated by the current registrants
and approved by the Agency. This standardized test material will
serve as the test substance for all toxicological testing as well
as other generic data requirements. If a registrant elects to
develop CTMs based on his own sources and processes, he must main-
tain the CTMs.
Rationale; The Agency must have data that are representativ*
of the range of coal tar/creosote products. Since the Composite
Test Material may not be the product of any one registrant's pro-
duction, the test material must be maintained for future reference
3. Toxicology studies. The Agency is requiring toxicology
studies on three AWPA standard products (Pi, P2C, and P2D) to
further evaluate the toxicological effects of coal tar and
creosote products. These studies must be conducted using a com-
posite of each of the standard products. A reference sample of
each Composite Test Material must be maintained, and the identity
and percentages of its components defined. If a registrant
elects to develop a CTM based on his own sources and processes,
he must conduct the full battery of required toxicological testing
Rationale; Because of the complexity of coal tar/creosote
composition and its variability depending on source, production
process and batch parameters, no single formulation is represen-
tative of the products currently produced. A Composite Test
Material based upon actual production of a number of products
will both permit registrants to avoid costly and duplicative
testing of individual products, while also enabling the Agency
to draw conclusions concerning the toxicological effects of coal
tar/creosote products in general.
The three mixtures selected for testing will encompass the
span of commercially available compositions ranging from a pure
distillation fraction of coal tar to the coal tar/creosote soluti<
containing the maximum content of coal tar. This range would als<
include the composition most widely employed in the wood preserva-
tion industry.
Data resulting from these studies will provide essential
baseline toxicological data on each of the three AWPA standard
products. These data will, in turn, serve as a basis for deter-
mining the degree of risk associated with each standard product.
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4. Ecological effects studies. The Agency has determined
that there are inadequate data to define the toxicity of coal tar
and creosote products to fish and other aquatic species. Studies
are required using typical end use formulation products used for
wood preservation in aquatic sites. The most widely used pro-
duct(P2C) must be used for avian, fish and invertebrate toxicity
testing. The PI and P13 products must be used in tests related
to freshwater and marine aquatic uses. If the data generated by
these studies demonstrate that typical AWPA products are hazardous
to fish and aquatic species, studies using treated wood may be
required.
Rationale; Fish and aquatic effects data should be based
upon actual exposure parameters if possible. EPA believes that
ecological effects testing should therefore be conducted initially
with AWPA products that are recommended for and specific to aqua-
tic sites, followed if necessary by testing using treated wood to
determine effects under simulated use conditions.
5. Environmental fate studies. The Agency is requiring all
data requirements for terrestrial and aquatic nonfood uses (40
CFR 158.130). Appropriate testing procedures/test materials will
be selected after the Agency evaluates completed product chemistry
data and other pertinent information.
Rationale; Coal tar/creosote products consist of a myriad
of individual chemical components. Since environmental fate
studies are designed to obtain i ^formation on individual consti-
tuents, alteration of the testing procedures and/or the normally
required test material may be warranted. Product chemistry and
other pertinent data will be utilized to select appropriate
procedures/test materials.
6. Protective clothing evaluation. The Agency is requiring
data on permeation and breakthrough time for protective clothing
materials. Studies must evaluate the degree to which protective
materials used for gloves and coveralls resist permeation. In
addition, mechanical abrasion and durability of the materials
must also be provided. Information on the types of materials
which must be tested is contained in Appendix I, Table A(Work
Exposure Section).
Rationale; Because coal tar/creosote formulations have the
ability to dissolve and/or permeate rubber gloves and some other
protective clothing, the Agency is requiring these studies to
determine which specific materials will offer the most protection
to workers.
7. Epidemiology feasibility study. The Agency is requiring
that registrants develop Information on conducting an epidemi-
ological study. The preliminary study consists of an assessment 1 -,
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of the availability and completeness of personnel records from
treatment plants, together with an assessment of similar records
in sawmills and planing plants for control purposes. Appendix I]
of this document is a questionnaire which may be used for this
purpose. The information obtained in the preliminary study will
be utilized in designing a comprehensive epidemiological study.
Rationale; Existing epidemiological data are inadequate to
fully assess the risks of use of coal tar/creosote products in
wood preserving plants because they failed to clearly define the
study population, to follow individuals, or to take into account
smoking habits of workers.
8. Work activities in wood preserving plants. The Agency
is requiring information on the kinds of work activities performs
in creosote treatment plants. Information on duration of exposui
and work activities involving dermal and inhalation exposure are
required. This information will be used together with the preli-
minary study to assist in the design of a comprehensive epidemio-
logical study.
Rationale; Information on typical work activities and ex-
posure situations must be incorporated into the epidemiological
study protocol.
9. Exposure studies. The Agency is requiring exposure
studies to measure the quantity and chemical makeup of chemicals
to which workers are exposed in wood preservative treatment
plants. These studies are to monitor ambient air exposures
(particulate and vapor phase) of coal tar/creosote as well as the
kind and extent of dermal and inhalation exposure at the various
work stations in wood treatment plants.
Rationale; Exposure studies are needed to adequately assess
risks to workers in treatment plants. The studies will be used
together with the laboratory animal toxicology studies to quantif
risks to workers and to identify exposure reduction measures in
treatment plants.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain AWPA coal tar/creosote standard products designated
as active ingredients, bear required labeling, and conform to the
product composition, acute toxicity limits, and use pattern re-
quirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
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To be registered or reregistered under this Standard, manu-
facturing-use products (MPs) must contain AWPA coal tar/creosote
standard products. Each formulation proposed for registration
must be fully described with an appropriate certification of
limits of the percentage of each standard product, as well as a
certification of limits for any inert ingredients which are
intentionally added.
2. Acute Toxicity Limits.
The Agency will consider registration of manufacturing-use
products containing coal tar/creosote provided that the product
labeling bears appropriate precautionary statements for the acute
toxicity category in which each product is placed.
3- Use Patterns
To be registered as a manufacturing use product under this
Standard, products may be labeled for formulation into end-use
products only for the uses 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
"Domestic, outdoor uses on: wood
D. REQUIRED LABELING
All manufacturing-use products must bear appropriate labeling
as specified in 40 CFR 162.10.
In addition to the above, the following information must
appear on the labeling:
!• Ingredients Statement
The ingredient statement for all products must list the
active ingredients as AWPA standard products, as appropriate:
PI %
P7 %
P13 %
P2A %
P2B %
P2C %
P2D %
P12 %
2. Signal word
The signal word DANGER must appear on the label of all coal
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tar/creosote products.
Use Pattern Statements
^.-^^^^-^*^^^^**^fm**t^**i^*^^i^m*^^*^*^^^^*m^*^^ f
All manufacturing use (MP) products must state that they e
intended for formulation into end use products for acceptable i
patterns. Labeling must specify sites, which are listed in Us€
Patterns, Section C.3. However, no use may be included on the
label where the registrant fails to agree to comply with the da
requirements in TABLE A for that use pattern.
4. Statement of practical treatment. Statements may be combin
to avoid redundancy.
If swallowed: Call a physician or Poison Control Center.
Drink 1 or 2 glasses of water and induce vomiting by touchi
back of throat with finger. Do not induce vomiting or give
anything by mouth to an unconscious person.
If in eyes: Flush with plenty of water. Call a physician.
If on skin: Wash with plenty of soap and water. Get medic;
attention.
If inhaled: Remove victim to fresh air. Get medical atten-
tion.
5. Precautionary statements; Hazards to Humans and Domestic
Animals
DANGER: May be fatal if swallowed, inhaled or absorbed
through skin. Causes skin and eye irritation. May cause
severe burns. Do not get in eyes, on skin or on clothing.
Do not breathe vapors or spray mist. Use with adequate
ventilation. Do not take internally. Wash thoroughly after
skin contact, before eating, drinking, use of tobacco pro-
ducts, or using restrooms.
6. Additional Precautionary statements for End Use Products
Additional precautionary/prohibition language is required on
product labels based on the intended uses of the product. As
presented below, there are five designated use categories for
coal tar/ creosote end use products that require such state-
ments.
a. Products labeled for pressure treatment of wood
RESTRICTED USE PESTICIDE
For sale to and use only by certified applicators or by
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persons under their direct supervision and only for those
uses covered by the certified applicator's certification.
Individuals must wear gloves impervious to the wood
treatment formulation in all situations where dermal contact
with creosote is expected (e.g., handling freshly treated
wood and manually opening cylinder doors).
Individuals who manually open cylinder doors must wear
gloves and a respirator.
Individuals who enter pressure treatment cylinders and
other related equipment that is contaminated with the wood
treatment formulation (e.g., cylinders that are in operation
or are not free of the treatment formulation) must wear
protective clothing (including overalls, jacket, gloves and
boots) impervious to the wood treatment formulation and a
respirator. Acceptable materials for protective clothing
during application and handling of this product are polyvinyl
acetate (PVA), polyvinyl chloride (PVC), neoprene and NBR
(Buna-N).
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 any general landfill, in the
trash, or in any other manner approved for pesticide disposal.
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 open-
ing/closing cylinder doors, moving trams out of cylinder,
mixing chemicals, and handling freshly treated wood).
Wash thoroughly, after skin contact, and before eating,
drinking, use of tobacco products, or using restrooms.
Note to User: As used on this label, the term "respira-
tor" means properly fitting, well-maintained, half-mask
canister or cartridge respirators which are MSHA/NIOSH-approved
for polynuclear aromatics and organic vapors. Examples of
acceptable materials for protective clothing (e.g., gloves,
overalls, jackets, and boots) required during application and
handling of creosote are polyvinyl acetate(PVA), polyvinyl
chloride (PVC), neoprene, and NBR (Buna-N).
b. Products labeled for groundline treatment of utility poles
RESTRICTED USE PESTICIDE
17
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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 applicator's certification.
Applicators must wear gloves impervious to the wood
treatment formulations (e.g., polyvinyl acetate (PVA),
polyvinyl chloride (PVC), or neoprene) in all situations
where dermal contact is expected (e.g., during the actual
application process and when handling freshly treated wood).
Applicators must wear long sleeved shirts, long pants,
and an impermeable apron during the application and mixing
processes and all situations where dermal contact is expected
Work clothing must be changed when it shows signs of
contamination. Launder work clothing separately from other
household laundry. Dispose of wornout work clothing and
workshoes or boots in any general landfill, in the trash,
or in any other manner approved for pesticide disposal.
Applicators must not eat, drink, or use tobacco pro-
ducts 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. Products labeled as wood preservatives for home and
farm use
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 (for example, during the actual application
process and when handling freshly treated wood).
Spray applicators must wear protective clothing
(including overalls, jackets, gloves, boots, and head
covering) impervious to the wood treatment formulation,
and a respirator and goggles when spraying.
Applicators who apply this product by other application
processes (e.g., brush-on) must wear long sleeved shirts,
long pants and an impermeable apron. Launder work clothing
18
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separately from other household laundry.
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.
Protective clothing must be changed when it shows signs
of contamination. Dispose of worn out protective clothing
and workshoes or boots in a general landfill, in the trash
or in any other manner approved for pesticide disposal.
Avoid inhaling vapors. If inhalation of vapors cannot
be avoided, applicators must wear a properly fitting, well-
maintained half-mask canister or cartridge respirator which
is MSHA/NIOSH approved for polynuclear aromatics and organic
vapors.
Do not apply where there may be direct contact with
domestic animals or livestock, and where there may be con-
tamination of food, feed, or drinking and irrigation water.
Do not apply in interiors. Do not apply to wood intended
for use in interiors except for those support structures
which are in contact with the soil in barns, stables, and
similar sites and which are subject to decay or insect
infestation. Interior surfaces of the treated wood should
be sealed with two coats of an appropriate sealers. Sealers
may be applied at the installation site.
Do not apply to wood intended for farrowing or brooding
facilities. Do not apply to wood intended to be used in the
interiors of farm buildings where there may be direct contact
with domestic animals or livestock which may crib (bite) or
lick the wood. This product may be used to treat wood intend-
ed to be used in interiors of farm buildings where domestic
animals or livestock are unlikely to crib or lick the wood,
if two coats of an appropriate sealer will be applied.
Sealers may be applied at the installation site.
Do not apply to wood intended to be used in a manner in
which 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 this product to treat wood intended to be
used for cutting boards or counter tops.
19
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Do not use this product to treat wood intended for con-
struction of those portions of beehives which may come into
contact with the honey.
Do not use this product to treat wood intended for use
where it nay come into direct or indirect contact with
public drinking water, except for those uses involving
incidental contact such as docks and bridges.
Do not use this product to treat wood intended to be
used where it may cone into direct or indirect contact with
drinking water for domestic animals or livestock, except for
uses involving incidental contact such as docks and bridges-
Wood to be treated with this product should be cut to
size before treatment. If it is necessary to saw or machine
wood after treatment, wear goggles to protect the eyes from
flying particles and a dust mask to aviod inhaling sawdust
from the treated wood. If oily preservatives or sawdust
accumulate on clothes, launder before re-use. Wash work
clothes separately from other household laundry.
Contact with treated surfaces should be avoided even
after the preservative has dried. When handling treated
wood wear long-sleeved shirts, long pants, and impervious
gloves (e.g., vinyl coated).
Wash exposed skin thoroughly after contact with treated
wood and before eating, drinking or using tobacco products-
Wood which has been treated with this product should be
disposed of by burial or ordinary trash collection. Do not
burn treated wood in an outdoor fire or in stoves or fire-
places because toxic chemicals may be produced as part of
the smoke and ashes.
This product should not be used to treat wood which will
be in frequent or prolonged contact with skin, unless the
wood will be treated with an effective sealer.
Note to User; As used on this label, the term
"respirator" means properly fitting, well-maintained, half-
mask canister or cartridge respirators which are MSHA/HIOSH-
approved for polynuclear aromatics and organic vapors.
Examples of acceptable materials for protective clothing
(e.g., gloves, overalls, head covering, jackets, and boots)
required during application and handling of creosote are
polyvinyl acetate(PVA), polyvinyl chloride (PVC), neoprene,
and NBR (Buna-N). Urethane, epoxy, and shellac are acceptable
sealers for all creosote-treated wood.
20
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d. Products labeled as wood preservatives for use
in non-pressure treatment plants
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 applicator's
certification.
Applicators must wear gloves impervious to the wood
treatment formulation in all situations where dermal
contact is expected (for example, during the actual
application process and when handling freshly treated
wood).
Spray applicators must wear protective clothing
(including overalls, jackets, gloves, boots, and head
covering) impervious to the wood treatment formulation,
and a respirator and goggles when spraying. Acceptable
materials for protective clothing during application
and handling of this product are polyvinyl acetate
(PVA), polyvinyl chloride (PVC), neoprene and NBR (Buna-N).
Individuals who enter, clean or repair vats, tanks
or other related equipment that is contaminated with the
wood treatment formulation (e.g., tanks that are in
operation or are not free of the treatment formulation)
must wear protective clothing (including overalls,
jacket, gloves and boots) impervious to the wood treatment
formulation, and goggles and a respirator.
Applicators who apply creosote by other application
processes (e.g., brush on) must wear disposable cover-
alls or other suitable impermeable protective clothing.
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.
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 any general land-
fill* in the trash, or in any other manner approved for
pesticide disposal.
Wash exposed skin thoroughly after contact with treated
wood and before eating, drinking or using tobacco products.
21
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Avoid inhaling vapors. If inhalation of vapors cannot
be avoided, applicators must wear a properly fitting, well-
maintained half-mask canister or cartridge respirator which
is MSHA/NIOSH approved for polynuclear aromatic and organic
vapors.
Note to User; As used on this label, the term "respira-
tor" means properly fitting, well-maintained, half-mask canis-
ter or cartridge respirators which are MSHA/NIOSH-approved for
polynuclear aromatics and organic vapors. Examples of accept-
able materials for protective clothing (e.g., gloves, over-
alls, jackets, and boots) required during application and
handling of creosote are polyvinyl acetate(PVA), polyvinyl
chloride (PVC), neoprene, and NBR (Buna-N).
e. Products labeled as wood preservatives for use in
pole framing, piling applications and railroad tie
repair
For pole framing, piling applications and railroad tie
repair use only. Not for household, farm, or nonpressure
wood treatment plant use. For application to end cuts, bolt
holes, and hardware fabrication.
Do not dilute or mix with other products. Ready for
use.
Applicators must wear gloves impervious to the wood
treatment formulation in all situations where dermal contact
is expected (for example, during the actual application pro-
cess and when handling freshly treated wood).
Spray applicators must wear protective clothing (includ-
ing overalls, jackets, gloves, head covering, and boots)
impervious to the wood treatment formulation, a properly
fitting, well-maintained canister or cartridge respirator
which is MSHA/NIOSH approved for polynuclear aromatics and
organic vapors, and goggles when spraying.
Railroad tie repair spray applicators operating a
mechanized tie sprayer (dual adzer) must wear longsleeved
shirts and long pants or other suitable protective clothing.
Applicators engaged in loading or maintenance of the spray
equipment or other activities which may result in exposure
to liquids, splashes or spills must wear long sleeved shirts,
long pants and an impermeable apron.
Wash exposed skin thoroughly after contact with treated
22
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wood and before eating, drinking or using tobacco products.
Railroad tie repair spray applicators operating non-
mechanized spray equipment must wear long sleeved shirts,
long pants and an impermeable apron, gloves and boots and
head covering impervious to the wood treatment formulation,
and a respirator and goggles. Applicators engaged in loading
or maintenance of the spray equipment or other activities
which may result in exposure to liquids, splashes or spills
must wear long sleeved shirts and long pants and an imper-
meable apron.
Applicators who apply creosote by other application
processes (e.g., brush-on) must wear long sleeved shirts,
long pants and an impermeable apron.
Protective clothing, workshoes or boots and equipment
must not be taken home.
Protective clothing must be changed when it shows signs
of contamination. Dispose of worn out protective clothing
and workshoes or boots in a general landfill, in the trash
or in any other manner approved for pesticide disposal.
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.
Applicators must complete an EPA approved training
program.
For the pole framing, piling applications and railroad
tie repair applications the label must also state:
For sale only to pole framing, piling and railroad tie
repair applicators.
For sale only in 10 gallon or larger containers. A
package of two five gallon containers is permissible.
Avoid inhaling vapors. If inhalation of vapors cannot
be avoided, applicators must wear a properly fitting, well-
maintained half-mask canister or cartridge respirator which
is MSHA/NIOSH approved for polynuclear aromatic and organic
vapors.
Note to User; As used on this label, the term "respira-
tor" means properly fitting, well-maintained, half-mask
canister or cartridge respirators which are MSHA/NIOSH-approved
for polynuclear aromatics and organic vapors. Examples of
acceptable materials for protective clothing (e.g., gloves,
23
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overalls, jackets, and boots) required during application
and handling of creosote are polyvinyl acetate(PVA),
polyvinyl chloride (PVC). neoprene, and,NBR (Buna-N).
7- Environmental Hazard Statements
The following statement must appear on all labels:
This pesticide is toxic to fish. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans or public waters unless this product is
specifically identified and addressed in an NPDES permit.
Do not discharge effluent to sewer systems without previously
notifying the sewage treatment plant authority. For guidance,
contact your State Water Board or Regional office of the EPA.
8. Disposal statements.
All products except household/domestic products
Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance.
Household/domestic products;
Securely wrap original pesticide container in several
layers of newspaper and discard in the trash. Do not
reuse empty containers.
24
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV-
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active_ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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2. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed 27
in this Registration Standard.
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that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
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
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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.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
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
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29
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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 as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your productfs)for which the data are needed.
30
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E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein/ these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from 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,
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.
G. 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
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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 by the 90-day 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 at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission 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.
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.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. 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
32
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.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 VI.D.I. (submit data)
or VI.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.
33
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix III - 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.
IX. INSTRUCTIONS FOR SUBMISSION
A- Manufacturing Use Products (MUPs) containing the subject
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 8570-27),
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.
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
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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).
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 the subject 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 8570-27),
if applicable.
2. Within 9 months of receipt of this document, you must
submit to the Product Manager:
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.
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3. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing the subject 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:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
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.
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. End Use Products containing the subject active ingredient
as one of multiple active ingredients"
Within 9 months from the receipt of this document, you
must submit to the Product Manager:
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 •»s
in 8-1/2 x 11 files. The draft labeling must indicate
the intended colors of the final label, clear indication
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of the front panel of the label, and the intended type
sizes of the text. End use product labeling must comply
specifically with the instructions in Section IV (Regulatory
Position and Rationale).
E. Addresses
The required information must be submitted to the following
address:
Lois Rossi
Product Manager 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.
37
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APPENDIX I
DATA APPENDICES
-------
TGUIDE-1
GUIDE TO TABLES
Tables A and B 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.
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
40
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TGUIDE-2
4. Doea EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that 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.
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GENERIC DATA
TABLE A
FOR OCftL TAR/CREOSOTE
Data Requirement Test Use
Substance^/ Patterns^/
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and Disclo-
sure of Ingredients
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Products
Ingredients
62-3 - Analytical Methods to Verify
Certified Limits
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point (or softening,
CTM
CTM
__-_ -
CTM
CTM
CTM
CTM
CTM
CTM
CTM
CTM
All
All
All
All
All
All
All
All
All
AU
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
NO
No
Must Additional Time Frame
Data be for
Submitted?3/ Submission
Yesj/
Yes^
Yes6/
No
No
No
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
if applicable)
<63-6 - Boiling Point Range
(if applicable)
CTM
All
No
Yes
6 Months
-------
GENERIC DATA
TABLE A
FOR ODAL TAR/CRB090TE
Data Requirement Test
Substance
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or CIM
Specific Gravity
63-8 - Solubility CIM
63-9 - Vapor Pressure CTM
63-10 - Dissociation constant
63-11 - Octanol/water partition CTM
coefficient
63-12 - pH CTM
63-13 - Storage Stability —
Other Requirements:
64- 1 - Submittal of samples CTM
- Submittal of protocol —
for development of CTM
Use
Patterns
All
All
All
All
All
All
All
All
All
Does EPA
Have Data?
No
No
No
No
No
No
No
No
No
Bibliographic Must Additional
Citation Data be
Submitted?
— Yes
— Yes
Yes
No
Yes
Yes
No
— Yesi/
Yes*
Time Frame
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
3 Months
I/ Test Substance: CTM = Composite Test Material corresponding to each AWPA standard. A protocol
for collecting the CTM must be submitted to and approved by the Agency prior to collection. Analyses
will be required to demonstrate that the CTM is indeed composite.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrrestrial, Non-Food; C = Aquatic, Food
Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
I = indoor.
3/ Data must be submitted within the indicated timeframes, which begin upon receipt of the Guidance Document.
-41-
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§158.120 Product Chemistry - continued
4/ Identification of major components, at concentrations XD.5%, in each coal tar/creosote C1M.
5/ Hie beginning material will be coal or wood. A description of the destructive distillation process
and the temperature ranges at which the various fractions are obtained will be required.
6/ Hie registrant must discuss all available information on the composition and toxicity of the components of
the eight AWPA standard products. This discussion should include the variability in chemical composition resulting
from the use of coal/wood from different geographical areas as well as different types of coal/wood. The
discussion should also address the presence and variability of each of the eight classes of compounds (naphthenes,
aromatic amines, etc.), identified in Sec. II.A. of this document.
7/ Composite Test Material must be made available to EPA upon request.
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TABLJS B
PRODUCT SPECIFIC DMA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING COAL TAR/CREOSOTE
Data Requirement Test Use
Substance^/ Patterns2/
$158.120 Product Chemistry
Product Identity
61-1 - Product Identity and Disclo-
sure of Ingredients
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Products
Ingredients
62-3 - Analytical Methods to Verify
Certified Limits
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point (or softening,
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
All
All
All
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
No
Must Additional Time Frame
Data be for
Submitted?3/ Submission
Yes4/
Yes5/
Yes6/
No
Yes^/
Yesf/
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
if applicable)
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING COAL TAR/CREOSOTE
Data Requirement Test
Substance
§158.120 Product Chemistry - continued
Physical and Chemical Characteristics
(Continued)
63-6 - Boiling Point Range MP
(if applicable)
63-7 - Density, Bulk Density, or MP
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure MP
63-10 - Dissociation constant —
63-11 - Octanol/water partition
coefficient
63-12 - pH
£.*! 1 *3 O4- AV"ii"**-h O4--»V»j 1 -I-^T
oj— J.J — otOfctye otciDllity
Other Requirements:
64- 1 - Submittal of samples MP
Use
Patterns
All
All
All
All
All
All
All
All
All
Does EPA
Have Data?
No
No
No
No
No
No
No
No
Bibliographic Must Additional
Citation Data be
Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
No
Vfo
— — — JJHJ
No
Time Frame
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
I/ Test Substance: MP = Manufacturing Use Product
7.1 The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrrestrial, Non-Food; C = Aquatic, Food
Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
I = Indoor.
ON
-------
§ 158.120 Product Chemistry - continued
3/ Data most be submitted within the indicated timeframes, which begin upon receipt of the Guidance Document.
4/ Identification of distillate fractions found in the MP is required. In addition, identification of
inert ingredients, if any, added to the product
5/ A description of the destructive distillation of coal/wood and the points at which the distillate fractions
are obtained is required. A description of the any formulation process used to make the MP.
6/ The registrant should discuss all available information on the composition and toxicity of the constituents
of the MP. In particular the discussion should include the presence and variability of the eight classes of
constituents identified in Sec. II.A. of this document.
Tj Each registrant must certify (1) That his product distillate ranges correspond to those identified by the
Agency, and (2) To the percentages of each distillate fraction in his MP conforming to the distillation
ranges.
8/ Methodology for distillation reflecting percentages and boiling ranges.
-45-
-------
TftBLE A
GENERIC DMA KKJUlKfcMQTIS fOR GOAL TAR/CSBOSOTE
Data
Test Use Does EPA Bibliographic
Substance1/ Patterns2/ Have Data? Citation
Must Additional Time Frame
Data be for
Submitted?3/ Submission
§158. IX) Eaviropaental Fate
STUDIES-LAB:
161-1 - Hydrolysis
Photodtaytadafc
To Be Determined B,D,H
161-2 - In
161-3 - On soil
161-4 - In Air
[JSM STUDIES-LAB:
No
To Be Determined
•fin |*a n«»*-<»r»i pert
To Be Debenined
To Be Detendned
Trt Ro noJ-^raiyiMil
TV) Ra rte4-f»rwi rwl
To Be DetermLned
B,D,H
B,D,H
B,D.H
B,D,B
BrD,H
BD H
9 A'***
B,D,H
No
lib
fib
No
No
M->
MJ*J
No
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162—3 — Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY SIPPEBS;
163-1 - Tfnrhirrj and To Be Determined B,D,H No
Adaorption/besorptian
163-2 - Volatility (Ld>) To Be Determined B,D,H No
163-3 - Volatility (Field) To Be Determined B,D,H No
Yes
To Be Scheduled
To Be
Reserved
^TJ-U-*
Reserved
Yes
Yes
Yes
TO Be
To Be Scheduled
To Be Scheduled
To Be Scheduled
GO
-------
A
TABLE A
maoauc unxn KEUUIKEMVIS KJR CUM. 'iAK/dOiJtiUUK
Pflfri^ ABQUCLX^BmVBDtt TSSt
flSB.130 Boviroomental Fate - Contimpri
(jil^&tlltarii^l tiTUUiKb— FIEtO?
164-1 - Soil To Be Determined
164—2 — Aouatic To Be Deter*! MF*'
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term To Be Determined
ffYTg£BJf[TC9I jfP [ill HS»
^ f C ^ •*-»*-• * f-— „-!, I, ,,
AO^"*» ** Ho^ationai ^Jxcps "™^*^
(Confined)
(Field)
165-3 - Irrigated Crops
165-4 - In Fish To Be Determined
165-5 - In Jfenatic Nan- To Be Dctermineri
Use
Patterns^
B,D,H
B,D,H
B,D,H
B,D,H
B,D,B
B.D.H
B,D,H
B,D,H
B,D,H
B,D,B
Does HA Bibliooraohic
/Rave Data? Citaticn
No
No
No
No
No
No
No
No
No
No
Must Additional
Data be
Submitted?3/
Yes To
Yes To
No
Nb*/
Reserved
NO
No
No
Yes To
Reserved
1 Time Frame
for
Submission
Be Scheduled
Be Scheduled
Be Scheduled
-47-
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR GOAL TAR/CREOSOTE
Data Requirement
Test Use Does EPA Bibliographic Must Additional Time Frame
Substance^/ Patterns^ Have Data? Citation Data be for
Submitted?3/ Submission
§158.140 Reentry Protection
132-1
132-2
133-3
133-4
- Foliar Dissipation
- Soil Dissipation
- Dental Exposure
- Inhalation Exposure
To Be Determined
To Be Determined
To Be Determined
To Be Determined
B,D,H No
B,D,H No
B,D,H No
B,D,H No
Reserved
Reserved
Reserved
Reserved
§158.142 Spray Drift
201-1
201-2
- Droplet Size Spectrum
- Drift Field Evaluation
To Be Determined
To Be Determined
B,D,H No
B,D,H No
Reserved
Reserved
I/ Selection of testing procedures and test materials are reserved until completion of the Agency evaluation of the
product chemistry data and other pertinent information.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food
Crop; D = Aquatic, Nonfood; E « Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframes, which begin upon receipt of the Guidance Document.
4/ Data are not currently being required for this Standard.
-48-
-------
TAELJE A
GENERIC DATA REQUIREMENTS FOR GOAL TAR/CREOSOTE
Data Requirement
§158. 35 - ADDITIONAL DATA REQUI
WORKER EXPOSURE STUDIES
Test Use Does EPA
Substance^/ Patterns2/ Have Data?
REMENTS 4/
Bibliographic
Citation
Must Additional
Data be
Submitted?3/
Time Frame
for
Submission
Worker Exposure in wood
treatment plant
- ambient air in wood
treatment plant
- inhalation exposure
- dermal exposure
Permeability of Protective
Materials
EPIDEMIOLOGY STUDIES
-Feasibility study, including
questionaire on treatment
plants
TEP or MP
NA
No
N/A
Each CTM NA.
No
TEP & MP NA.
No
Yesf/
Yes7/
6 Months
12 Months
18 Months
-Work activities in treatment
plants
-Epidemiology study
TEP & MP NA
TEP & MP NA
NO
No
Yes?/
Reservedly
6 Months
I/ Test Substance: CTM = Composite Test Material corresponding to each AWPA specification. A protocol
for collecting the CTM must be submitted to and approved by the Agency prior to collection. Analyses
will be required to demonstrate that the CIM is indeed composite. MP = Manufacturing use product;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = flquatic, Food
Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I - Indoor.
Sf Data must be submitted within the indicated timeframss, which begin upon receipt of the Guidance Document.
-49-
-------
§158.35 - ADDITIONAL DATA REQUIREMENTS - continued
4/ This information and data are requested under authority of Section 158.35, Paragragh (C) which allows the
Agency to obtain additional data or information beyond that specified in the Guidelines.
5/ Monitoring is to be conducted using fixed station air sampling and personal dermal and inhalation exposure
monitoring. Registrants should consult with the Agency before beginning study to discuss protocols and iden-
tify marker chemicals for which analysis must be done. Protocol must be submitted within 6 months from re-
ceipt of this Guidance Document.
6/ Data must be submitted regarding the permeability of various materials used for protective clothing and equip-
ment (gloves, boots, protective garments, etc.) for each CIM. If these data are not available, then they must
be generated using methods described in American Society of Testing and Materials (ASTM) 739-81 - Standard Test
Method for Resistance of Protective Materials to Permeation by Hazardous Liquid Chemicals. Analytical proce-
dures for these tests may take the form of gravimetric measurement of coal tar/creosote passing through the
test materials or qualitative analysis for breakthrough products. The protective materials which must be
tested include vinyl, polyvinyl chloride (PVC), neoprene, NBR (Buna-N), rubber, and polyethylene. Tests on
additional materials such as VITON and TYVEK® may be required at the request of the Agency.
7/ A list of questions for registrants who own, operate or sell their product to creosote wood treatment plants
is presented in Attachment II and a list of questions for registrants who operate sawmills and/or planing mills
yards using untreated wood is presented in Attachment III. Registrants may either use Attachments II and/or
III to provide the required personnel information or may submit the information in another format if desired.
In order to complete the study by the timeframe indicated, the questionnaire should be completed in 12 months.
&/ This report must include the area in the vicinity of the cylinder door, the control room, the area adjacent to
the pumps and valves, and the holding area. Activities which must be reported include all tasks preceding and
including actual wood treatment through shipment. The report should estimate average hours per day, days per
year and average years of activity that a worker is involved in each task. If the individual typically performs
more than one work activity, it must be described. Records indicating exposure should be submitted, for example,
for workers transferred to other assignments because of sensitization to creosote. The report should also in-
clude all available and relevant work logs, and the estimates of work hours should be justified by reference to
these logs. The type of clothing worn, including protective gear such as gloves or respirators, must be des-
cribed in detail for each work activity and should include care and maintenance of the protective gear. The
number of individuals involved in each work activity must be estimated and the existence of industrial hygiene
training programs or supervision must be documented.
9/ Reserved pending the submission of the preliminary study and questionnaire information.
LO
f\J
-50-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR COKL TAR/CREOSOTE ACTIVE INGREDIENTS
Date Requirement Test
Substance1
§158.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity P1,P2C,P2D
- Rat
81-2 - Acute Dermal Toxicity P1,P2C,P2D
- Rabbit
81-3 - Acute Inhalation Toxicity P1,P2C,P2D
- Rat
81-4 - Primary Eye Irritation P1,P2C,P2D •
81-5 - Primary Dermal Irritation P1,P2C,P2D
81-6 - -~n»l Sensitization P1,P2C,P2D
81-7 - Acute Delayed Neuro-
toxicity - Hen
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding:
- Rodent (rat) and,
- Non-rodent (Dog)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal Pl,P2C,P2D
82-4 - 90-Day Inhalation: P1,P2C,P2D
-Rat
82-5 - 90-Day Neurotoxicity:
~T - Hen/Mammal
Use
Patterns^/
B,D,H
B,D,H
B,D.H
B,D,H
B,D,H
B,D,H
B,D,H
B,D,H
B,D,H
B,D,H
B,D,H
B,D,H
B,D,H
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
No
No
No
No
-51-
Must Additional
Data be
Submitted3/
Yes
Yes
Yes
Yes
Yes
Yes
No4/
No5/
Nc5/
No*/
Yes
Yes
No7/
Time Frame
for
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
15 months
15 Months
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR GOAL TAR/CREOSOTE
Data Requirement
§158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Tbxicity -
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 - Oncogenicity Study
- Mouse (preferred)
83-3 - Teratogenicity -
1 species (rat/rabbit)
83-4 - Reproduction - Rat
2-generation
MUEAGENICITY TESTING
84-2 - Gene Mutation (Ames Test)
84-2 - Structural Chromosomal
Aberration
84-4 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal Safety
Test Use
Substance1 Patterns2
B,D,H
B,D,H
P1,P2C,P2D B,D,H
P1,P2C,P2D B,D,H
B,D,H
P1.P2C.P2D B,D,H
P1,P2C,P2D B,D,H
P1,P2C,P2D B,D,H
B,D,H
B,D,H
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
No
Must Additional
Data be
Submitted?3/
No5/
No5/
Yes?/
Yes
No5/
Yes
Yes
Yes
,
No5/
No5/
Time Frame
for
Submission
50 Months
15 Months
9 Months
12 Months
12 Months
Ui
-52-
-------
§158.135 Toxicology - Continued
Tests must be conducted with the Composite Test Material of AWPA standard products PI, P2C and P2D.
The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrrestrial, Non-Food; C = Aquatic, Food
Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
I = Indoor.
3/ Data must be submitted within the indicated timeframe, which begin upon receipt of this Guidance Document.
4/ This test is required only for compounds which are organophosphate inhibitors of cholinesterase, or related to such
!/ This study is not required under the existing use patterns.
H/ This study is not required because of the requirement for a 90-day dermal toxicity study.
7/ This study is only required for studies which have been tested positive in the acute delayed neurotoxicity test.
Therefore this study is not required.
8/ Six-month Senkar mouse skin painting study.
-53-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR GOAL TAR/CREOSOTE
Data Requirement
Test Use
Substance^/ Pattern2/
Does EPA
Have Data?
Bibliographic Must Additional
Citation Data be
Submitted?3/
Time Frame
for
Submission
§158.145 Wildlife and Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LDjQ
71-2 - Avian Dietary LCso
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing
-Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LCso
- Warmwater (bluegill)
- Coldwater (trout)
72-2 - Acute LCso Freshwater
-Invertebrates
72-3 - Acute LCso Estuarine
and Marine Organism
- Fish
- Shrimp
-Oyster
CTM,P2C B,H,D
~— "•
CTM,P1,P2C B,H,D
CTM,P1,P2C B,H,D
CTM,P1,P2C B,H,D
CTM,P2C,P13 D
CTM,P2C,P13 D
CTM,P2C,P13 D
No
No
No
No
No
No
No
No
No
No
No
Yes4/
NO
No
No
No
Yes
Yes
Yes
Ye85y
Yes^/
Yes5/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-54-
-------
GENERIC DATA
TABLE A
FOR OQAL TAR/CREOSOTE
Data Requirement
Test Use Does EPA Bibliographic
Substance^/ Pattern2/ Have Data? Citation
Must Additional Time Frame
Data be for
Submitted?3/ Submission
§158.145 Wildlife and Aquatic Organisms - Continued
72-4 - Fish Early Life Stage
- Freshwater
- Estuarine
Aquatic Invertebrate
Life-Cycle
- Freshwater
- Estuarine
72-5 Fish Life-Cycle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing
72-8 - Special Test
CTM P1,P2C D
CTM P13,P2C D
CTM P1,P2C D
CTM P13,P2C D
D
D
No
No
No
No
No
No
No
No
Reserved6
Reserved6
Reserved6/
Reserved6/
Reserved^/
Reserved^/
Reserved?/
I/ Tests must be conducted with the Composite Test Material of AWPA standard products PI, P2C and P13.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrrestrial, Non-Food; C = Aquatic, Food
Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
I = Indoor.
3/ Data must be submitted within the indicated timeframe, which begin upon receipt of this Guidance Document.
4/ An acute oral LDso study on a mallard duck or bobwhite quail using a sample of the AWPA P2C standard for creosote
is required rather than a dietary study on bobwhite quail. A more accurate 11)50 *s lively to be derived as a
dietary study would probably result in some repellancy.
-55-
-------
§ 158.145 - Wildlife and Aquatic Organisms - continued
5/ Testing nust be conducted with AWPA standard formulations P2C and P13 recommended for use in a saltwater environment.
6/ These studies are reserved pending submission of the aquatic toxicity studies using the PI, P2C and P13 products.
If the CTM is found to result in an LCso less than 1.0 ppm nominal concentration to aquatic organisms, the test will
be required.
Tj If the results of the acute 96-hr study indicate I£so values below those residues determined to be present in
water resulting from treated pilings, the test must be conducted using wood treated according to the use directions
for the appropriate MUP.
i) A flow-through system should be used. 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 test organisms, should be set up as in
a normal study but with a provision for recirculation. The second tank should be large, at least 200 gallons,
so that waste products may be diluted to maintain good water quality. In the second tank, the treated wood
should be placed in such a way as to maximize the surface area, i.e., using l"(inch) boards spaced apart rather
than using 4"x4" posts. The surface area of wood used should be l/100th of the volume of the tank. Three
replicates of each treatment group should be performed.
ii) One 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).
iii) One control tank without wood should be established.
iv) The test material(PI,P2C, and P13) will be selected after reviewing the data from 72-1 and 72-3. The concen-
tration of the test materials measured by an appropriate liquid chromatography method should be measured bi-
weely.
iv) To insure that the water quality at the beginning of the test is the highest possible. Refer to "Methods for
Acute Toxicity Tests for Fish, Macroinvertebrates and Amphibians", EPA-660/3-75-009 April, 1975. The dilution
water should be assayed for PI and P13 constituents. All other test standards and data reporting should conform
to the guidelines for a fish early life-cycle stage test as set forth in EPA's Pesticide Assessment Guidelines:
Subdivision E.
8/ Refer to EAB test requirements.
9/ This study is reserved pending the results of the "leaching from wood/toxicity" study.
10/ Pending the results of the presently reserved 72-4 studies.
eb
-56-
-------
APPENDIX II
FEASIBILITY OF A CANCER EPIDEMIOLOGY STUDY
The U.S. Environmental Protection Agency (EPA) is interested
in receiving a health study of creosote wood treatment operators.
To determine the feasibility of such a study we are requiring
creosote wood treatment plants to provide certain information
regarding employment, medical, and industrial hygiene records.
In addition, we are asking for certain description information
regarding the treatment plants.
EPA is aware that some coal tar/creosote registrants main-
tain sawmills and/or planing mills and is considering using sawmill
and/or planing mill workers as a comparison group for the creosote
treatment plant workers. Thus, similar information on records
and descriptive information is being requested for sawmills and
planing mills. In addition to sawmill and/or planing mill workers,
the Agency is interested in other possible comparison groups.
The major criteria for a comparison group for the kinds of studies
the Agency is seeking are:
1. Similar sunlight exposure to that received by creosote
treatment plant workers, and
2. A working environment that is relatively free of known
chemical carcinogens.
If you have employees in other divisions or are aware of any
groups of people who might be suitable for a comparison group,
please describe.
-------
Copies of questionnaires for (1) creosote treatment plants
and (2) sawmills and/or planing mills are included in this package.
Please note that we have included questionnaires for creosote
treatment plants and sawmills and/or planing mills that are both
currently operating and have closed. Please complete one "Creosote
Treatment Plant Questionnaire" for each creosote treatment plant
that you currently operate or have closed and one "Sawmill and/or
Planing Mill Questionnaire" for each sawmill and/or planing mill
that you currently operate or have closed using the appropriate
questionnaire form, if you need additional copies of question-*
naires please contact Lois A. Roesi at (703) 557-1900. If you do
not operate or have formally operated either creosote treatment
plants or sawmills and/or planing mills, a response indicating
such is required.
-------
6!
-------
ATTACHMENT II
QUESTIONNAIRE
FOR
CURRENTLY OPERATING
CREOSOTE TREATMENT PLANTS
The U.S. Environmental Protection Agency Is Interested 1n a health
survey of creosote treatment workers. The purpose of this questionnaire 1s
to determine what kinds of employment, medical, and Industrial hygiene records
are available for your creosote treatment plant and 1n what format such records
currently exist. Employee records to be considered are those for salaried and
hourly employees 1n the creosote treatment plants. In addition, we are
Interested 1n certain descriptive Information of the plant and the makeup of
the workforce.
We recognize that record keeping systems vary from plant to plant. This
survey 1s not Intended to evaluate specific company systems; rather, 1t 1s
Intended to see how Individual systems can be Integrated for the purpose of
evaluating the health of workers engaged 1n creosote wood treatment.
For your convenience, this questionnaire 1s divided Into six sections.
These are:
1. Descriptive Information
2. Payroll records
3. Personnel records
4. Employment applications
5. Medical records
6. Industrial hygiene
•If additional space Is needed In answering any of the questions, please
continue on the back of the page or use blank sheet?, specifying the question
by number and letter.
-------
DESCRIPTIVE INFORMATION
1. Company name:
Name of local facility:
Local address:
Name(s) and address(es) of union(s) representing employees:
a.
b.
c.
2. What year did the plant begin operation?
3. If plant was closed for any period of time, indicate when and why,
Years Closed Reason
a.
b.
4. If the plant has changed ownership, give the name(s) and address(es) of previous
owner (s) and the year(s) that ownership changed:
Year Ownership
Name Address Changed
a.
-------
Year Ownership
Name Address Changed
b.
5. For the following years, estimate how much creosote, 1n pounds, was used,
(If for any particular year, the number of pounds 1s unknown or response
1s not applicable, so state.)
Year Pounds of Creosote
Current
1980 ~
1975
1970 ~
1965
6. Have any preservatives other than creosote ever been used?
C ] No
[ ] Yes If Yes, name other wood preservatives used and the time period
(month/year) during which they were used.
Wood Preservative Year(s) Used
a. from /19 to /19
b. from /19 to /19
c. from /19 to /19
d. from /19 to /19
e. from 719 to /19
7. Is/Was pressure treatment used at this plant?
[ 3 No
.[ ] Yes If Yes, answer both a and b below.
a. List the time period (month/year) during which pressure treatment
was used.
(1) from
(2) from
(3) from
64
-------
b. State the number of treatment cylinders at the plant for the
following years. (If the number of cylinders for any particular
year 1s unknown or response 1s not applicable, so state.)
Number of Cylinders
(1) 1984
(2) 1980
(3) 1970
i960
1950
1940
8. Is/Was non-pressure treatment used at this plant?
C 3 No
[ ] Yes If Yes, Indicate the time period (month/year) during which non-pressure
treatment was used.
a. from
b. from
c. from
/19
/19
/19
to
to
to
719
719
719
9. How many people do you currently employ?
10. Has the size of the workforce changed substantially since the plant opened?
C 3 No
[ 3 Don't know
[ 3 Yes If Yes, how has 1t changed?
11. How many current employees are:
a. Under 30 years of age?
b. Over 50 years of age?
. c. Male?
12. What Is the average turnover rate of workers per year? percent.
13. Has the turnover rate changed since the plant opened?
C 3 No
[ 3 Don't know
[ 3 Y-es If Yes, how has 1t changed?
65
-------
14. How many employees work 1n the following areas?
Work Area Number of Employees
a. Production
b. Maintenance
c. Administration
d. Other
15. What percent of current employees are:
a. White? percent
b. Black? percent
c. Hispanic American? percent
d. Oriental? percent
e. Other? percent
16. Have these percentages by race/ethnic background (Question 15) changed
significantly over the years this plant has been 1n operation?
C ] No
C ] Don't know
[ ] Yes If Yes, Indicate how they have changed.
17. Approximately what percent of employees at the plant are exposed to creosote
1n the plant operating environment (as opposed to working almost exclusively
1n an office)?
percent
18. Of those employees who work with creosote, how much of their average workday
1s spent outdoors?
[ ] Less than half their workday.
[ ] Approximately half their workday.
[ ] More than half their workday.
19. How many of the workers that you currently employ have worked at your plant
for:
•*
a. Less than 2 years?
b. 2-5 years? r
c. 6-10 years?
d. More than 10 years?
-------
20. Plant personnel who could, be contacted by the U.S. Environmental Protection
Agency regarding this survey:
Main contact - Name
Title
Phone number
Personnel and/or Benefits
Records Manager - Name
Title
Phone number
Data Processing - Name
Title
Phone number
67
-------
PAYROLL RECORDS/ACTIVE EMPLOYEES
The following questions are specifically about payroll records.
1. Are payroll records stored 1n a computer file (e.g., on tape or disk)?
C ] No
[ ] Yes If Yes, what kind of computer do you have?
Model
[ ] Portable (e.g., Radio Shack Model 100) ..........
[ ] Transportable (e.g., Osbourne, Kaypro, Compaq) ......
[ ] Dedicated Word Processor (e.g., Lanler, IBM displaywrlter)
[ ] Micro (e.g., Apple, IBM PC) ...............
[ ] Mini (e.g., PDP-11) ...................
[ ] Super-mini (e.g., VAX, IBM 4341) .............
[ ] Main Frame (e.g., DEC System 10, IBM 3033) ........
[ ] Class VI Supercomputer (e.g., CRAY, Cyber) ........
[ ] Other (Please specify) _
2. Which of the following Items are Included on computer and/or hard copy
(paper) payroll records? Check all that apply.
Computer
Record
C ]
C ]
C ]
C ]
C ]
C ]
C ]
C ]
C ]
C ]
Paper
Record
C ]
C 1
C ]
[ 3
C ]
C ]
C ]
C ]
C ]
C ]
Items
Name
Social security number
B1 rthdate
Date of hire
Current job title
Current job code
Type of work (maintenance, production,
administration, etc.)
Current work location (shop, department, etc.)
Previous job titles
Employee number
3. If a worker 1s terminated (retired, discharged, etc.), 1s his record
eventually destroyed or deleted from the file?
C 3 No
[ ] Yes If Yes, how long, on the average, 1s the record retained before
being destroyed? _
68
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4. Are records on current employees sent to a central repository at periodic
Intervals (e.g., corporate headquarters)?
[ ] No
[ ] Yes If Yes, how many times per year are records sent to a central
repository? times per year
PLEASE ATTACH A BLANK COPY OF YOUR PAYROLL RECORD FORM AND, IF APPLICABLE,
THE FORM USED TO GENERATE A NEW COMPUTER-BASED PAYROLL RECORD.
69
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PERSONNEL, RECORDS/ACTIVE AND TERMINATED
The following questions concern what 1s done with personnel records under
different circumstances. The questions are repetitive, but please provide answers
to all of the questions even 1f the responses are the same.
1. In what form are personnel records kept? Check all that apply.
[ ] Card files
[ ] Paper files (e.g., 8 1/2 x 11 Inch file folders)
[ ] Wheel file
[ ] Microfilm
[ ] Computer files
[ ] Other files, specify type
2. How are personnel records on active employees organized (e.g., alphabetically
by name, by department, etc.).
3. If personnel files are NOT on computer, please answer this question,
Are you planning to convert to a computer system?
C ] No
[ ] Yes If Yes, when are you planning the conversion?
4. Which of the following Items are recorded in personnel records? Please check
all Items that apply.
[ ] Name
[ 3 Social security number
[ 3 Birthdate
[ ] Birthplace
[ ] Race
C ] Sex
[ ] Father's name
[ ] Mother's maiden name
[ 3 Spouse's and children's names and addresses
[ 3 Date of hire
.f ] Date of termination
[ ] Reason for termination (e.g., retired, disabled, discharged, died)
[ ] Work type (administrative, production, maintenance)
[ ] Work location
[ 3 Current job title
[ 3 Any previous job title(s) with this plant
[ 3 Date of job title changes
Residence address
Employee number
-------
5. Have personnel records ever been destroyed by accident (e.g., fire, flood)?
C ] No
[ ] Yes If Yes, please describe the records destroyed.
6. Do you retain records on former employees?
C ] No
[ ] Yes If Yes, answer a and b below.
a. Estimate the approximate number of records you have on former
employees.
b. Estimate the approximate number of retired workers who are receiving
benefits.
Questions 7-12 refer to personnel records of former employees.
7. Retired Employees
a. What happens to the personnel records of an employee who retires?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Stored in a separate file of retired employees
[ ] Other
b. How are records on retired employees organized?
[ 3 Alphabetically by name
[ ] By department and alphabetically by name
[ 3 By year of retirement
[ ] Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
..d. Are personnel records of retired employees ever destroyed?
C 3 No
[ ] Yes If Yes, how long are they retained before being destroyed?
years
-------
e. If a retired employee-dies, is a copy of the death certificate obtained?
C ] No
[ ] Yes If Yes, where is the death certificate filed?
8. Employees Deceased While Employed
a. What happens to the personnel records of an employee who dies while still
employed? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How are records on deceased employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
C ] By year of death
[ ] Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
d. Are personnel records of deceased employees ever destroyed?
C ] No
[ ] Yes If Yes, where is the death certificate filed?
9. Employees Who Voluntarily Terminate Employment
a. What happens to the personnel records of an employee who terminates
voluntarily? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How are records on terminated employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
[ ] By year of termination of employment
[ ] Other
72
-------
c. If the personnel records are stored separately from current employee
records, where are they storecj?
d. Are personnel records of employees who terminate voluntarily ever destroyed?
[ ] No
[ ] Yes If Yes, how long are they retained before being destroyed?
years
10. Discharged Employees
a. What happens to the personnel records of an employee who is discharged?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How are records on discharged employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
[ 3 By year of discharge
[ ] Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
d. Are personnel records of discharged employees ever destroyed?
[ ]No
[ ] Yes If Yes, how long are they retained before being destroyed?
years
11. Employees Who Are Laid Off
a. What happens to the personnel records of an employee who is laid off?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
73
-------
b. How are records on emgloyees who are laid off organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
[ ] By year the employee was laid off
[ ] Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
d. Are personnel records of employees who are laid off ever destroyed?
C 3 No
[ ] Yes If Yes, how long are they retained before being destroyed?
years
12. Disabled Employees
a. What happens to the personnel records of an employee who 1s disabled?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
C ] Other
b. How are records on disabled employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
C ] By year that employment ended
[ ] Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
d. Are personnel records of disabled employees ever destroyed?
C 3 No
[ ] Yes If Yes, how long are they retained before being destroyed?
years
PLEASE ATTACH A BLANK COPY OF YOUR PERSONNEL RECORD FORM TO THIS QUESTIONNAIRE
74
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EMPLOYMENT APPLICATIONS
(for those who have been hired)
1. In what form are these employment applications kept?
[ ] Card file
[ ] Paper file (e.g., 8 1/2 x 11-inch file folder)
[ ] Wheel file
C ] Microfilm
[ 3 Computer file
[ 3 Other files, specify type
2. Which of the following items are on employment applications? (Check all
that apply.)
[ ] Name
[ 3 Social security number
[ 3 Birthdate
[ ] Residence address
[ 3 Previous work history
3. Where are these employment applications stored?
[ 3 Personnel files
[ 3 Separate file of applications
[ 3 Other
4. Are the employment applications of former workers ever destroyed?
C 3 No
[ 3 Yes If Yes, how long are they kept?
75
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MEDICAL RECORDS
1. Do you give pre-employment physical examinations?
[ ] No
[ ] Yes If Yes, answer both a and b below.
a. When did you begin this practice?
b. Where are the examinations given?
[ ] on-slte clinic
[ ] off-site clinic
[ ] on and off-site clinics
2. Are medical records of employees retained at the plant?
C ] No
C ] Yes
3. Are medical records ever destroyed?
C ] No
[ ] Yes If Yes, how long are they retained before being destroyed?
years
4. Do you regularly collect smoking history for the medical record?
[ ] No
C ] Yes
5. What types of medical exams do you regularly conduct?
[ ] Hearing assessment
C ] Pulmonary function
[ ] General physical
[ ] Other
6. How many full-time equivalent (FTE) medical staff do you employ?
FTE Medical Staff
a. Physicians
b. Nurses
c. Technicians
PLEASE ATTACH A BLANK COPY OF YOUR PRE-EMPLOYMENT EXAMINATION FORM f £
-------
INDUSTRIAL HYGIENE QUESTIONS
1. Do you have one or more Industrial hygiene professionals at this plant?
C ] No
[ ] Yes If Yes, please furnish the name and telephone number of the
supervisor or director of Industrial hygiene.
I _)-
Name Phone number
2. Does a corporate hyglenlst provide service and/or consultations at your
facility?
C 3 No
C ] Yes
3. Do you have a part-time or collateral duty person who
does Industrial hygiene at your facility?
C ] No
[ ] Yes If Yes, please furnish his or her name and telephone number.
Name Phone number
4. Does anyone else provide Industrial hygiene consultation?
C 3 No
[ ] Yes If Yes, who?
5. Do you measure Workplace exposures to chemical agents at this plant?
C ] No
C 3 Yes
fHANK YOU FOR TAKING THE TIME TO ANSWER THESE QUESTIONS.
77
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Attachment C-2
QUESTIONNAIRE FOR CREOSOTE TREATMENT PLANTS THAT HAVE CLOSED
The U.S. Environmental Protection Agency 1s Interested in conducting a
health survey of current and former creosote treatment workers. The purpose
of this questionnaire is to determine what kinds of employment, medical, and
industrial hygiene records still exist for creosote treatment plants that have
been closed and in what format such records were kept. Employee records to be
considered are those for salaried and hourly employees. In addition, we are
Interested in certain descriptive information on the plant and the makeup of
the workforce during the operation of the plant.
We recognize that record-keeping systems vary from plant to plant. This
survey is not intended to evaluate specific company systems; rather, 1t 1s
intended to see how individual systems can be Integrated to evaluate the health
of workers engaged or formerly engaged in creosote wood treatment.
For your convenience, this questionnaire is divided Into six sections.
These are:
1. Descriptive Information
2. Payroll records
3. Personnel records
4. Employment applications
5. Medical records
6. Industrial hygiene
If additional space 1s needed in answering any of the questions, please
continue on the back of the page or use blank sheets, specifying the question
»
by number and letter.
We welcome your comments. You may write them next to specific questions
or on separate pages. Please feel free to call
at ( )- 1f you have any questions.
78
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DESCRIPTIVE INFORMATION
1. Company name:
Name of local facility:
Local address:
Name(s) and address(es) of union(s) that represented your employees:
a.
b.
c.
2. What year did the plant begin operation?
3. What year did it close?
4. If the plant was closed for any period of time prior to Its final closing,
indicate when and why.
Years Closed Reason
a.
b.
If the plant changed ownership at any time in Us history, give the name(s)
and address(es) of previous owner(s) and the year(s) that ownership changed:
Year Ownership
Name Address Changed
a.
-------
Year Ownership
Name Address Changed
b.
6. For the following years, estimate how much creosote, 1n pounds, was used.
(If for any particular year the number of pounds 1s unknown or response
1s not applicable, so state.)
Year Pounds of Creosote
a. Last year of operation
b. Five years before plant closed
c. Ten years before plant closed
d. Fifteen years before plant closed
e. Twenty years before plant closed
7. Were any preservatives other than creosote ever used at the plant?
C ] No
[ ] Yes If Yes, name other wood preservatives used and the time period
(month/year) during which they were used.
Wood Preservative Year(s) Used
a. from 719 to 719
b. IZZHZH^IZI f rom 719 to /19
c. from /19 to 719
d. from /19 to /19
e. from 719 to /19
8. Was pressure treatment used at this plant?
C ] No
[ ] Yes If Yes, answer both a and b below.
a. List the time period (month/year) during which pressure treatment
was used.
(1) from /19 t o /19
(2) from /19 to 719
(3) from 719 to 719
80
-------
b. State the number of treatment cylinders at the plant for the
following years. (If the number of cylinders for any particular
year is unknown or response is not applicable, so state.)
Year Number of Cylinders
(1) Last year of operation _ _
(2) Five years before plant closed _ _
(3) Ten years before plant closed _ _
(4) Fifteen years before plant closed _ _
(5) Twenty years before plant closed _ _
9. Was non-pressure treatment used at this plant?
[ 3 No
C ] Yes If Yes, indicate the time period(s) (month/year) during which non-
pressure treatment was used.
a. from _ /19 _ to _ /19 _
b. from /19 to
c. from /19 to /19
10. How many people were employed at the plant one year before it closed?
11. Did the size of the workforce change substantially over the period of time
that the plant was operating?
[ ] No
[ ] Don't know
C ] Yes If Yes, how did it change?
12. One year before the plant closed, how many employees were:
a. Under 30 years of age?
b. Over 50 years of age?
c. Male?
13. What was the average turnover rate of workers during the last five years of
the plant's operation? percent.
81
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14. Did the turnover rate change over the period of time that the plant was
operating?
[ ] No
[ J Don't know
[ ] Yes If Yes, how did it change?
15. One year before the plant closed, how many employees were working in the
following areas?
Work Area Number of Employees
a. Production
b. Maintenance
c. Administration
d. Other
16. One year before the plant closed, approximately what percent of the employees
were:
a. White percent
b. Black percent
c. Hispanic American percent
d. Oriental percent
e. Other percent
17. Did these percentages by race/ethnic background (Question 15) change
significantly over the years the plant was in operation?
C ] No
[ ] Don't know
[ ] Yes If Yes, Indicate how they changed.
18. Approximately what percent of employees at the plant were exposed to creosote
in the plant operat1ng environment (as opposed to working almost exclusively
in an office)?
percent
82
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19. Of those employees who worked with creosote, how much of their average workday
was spent outdoors?
[ ] Less than half their workday.
[ ] Approximately half their workday.
[ ] More than half their workday.
20. How many of the workers who were employed at that plant one year before it
closed had worked for:
a. Less than 2 years?
b. 2-5 years?
c. 6-10 years?
d. More than 10 years?
21. Former plant personnel who could be contacted by the U.S. Environmental
Protection Agency regarding this survey:
Main contact - Name
Title
Phone number
Personnel and/or Benefits
Records Manager - Name
Data Processing - Name
Title
Phone number
(
Title
Phone number
Industrial Hygiene - Name
Title
Phone number
-------
PAYROLL RECORDS
The following questions are specifically about payroll records.
1. Were payroll records stored in a computer file (e.g., on tape or disk)?
[ ] No
[ ] Yes If Yes, what kind of computer did you use?
Model
[ ] Portable (e.g., Radio Shack Model 100)
[ ] Transportable (e.g., Osbourne, Kaypro, Compaq)
[ ] Dedicated Word Processor (e.g., Lanier, IBM displaywriter)
[ ] Micro (e.g., Apple, IBM PC)
[ ] Mini (e.g., PDP-11)
[ ] Super-mini (e.g., VAX, IBM 4341)
[ 3 Main Frame (e.g., DEC System 10, IBM 3033)
[ ] Class VI Supercomputer (e.g., CRAY, Cyber)
[ ] Other (Please specify)
2. Which of the following items were Included on computer are/or hard copy
(paper) payroll records? Check all that apply.
Computer
Record
C 3
C 3
C 3
C 3
[ ]
[ ]
C 3
[ ]
[ ]
[ 3
Paper
Record
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
Items
Name
Social security number
Birthdate
Date of hire
Job title
Job code
Type of work (maintenance, production,
administration, etc.)
Work location (shop, department, etc.)
Previous job titles
Employee number
3. If a worker was terminated (retired, discharged, etc.) while the facility
was in operation, was his record eventually destroyed or deleted from the
file?
C 3 No
[ 3 Yes If Yes, how long, on the average, was the record retained before
being destroyed?
84
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4. Were payroll records on employees sent to a central repository (e.g.,
corporate headquarters) at periodic intervals when the facility was
in operation?
[ ] No
[ ] Yes If Yes, answer a and b below.
a. How many times per year were records sent to a central
repository? times per year
b. Where is/was the central repository?
5. After the plant closed payroll records were:
[ ] Kept at the facility
[ ] Forwarded to a central repository
[ ] Destroyed
[ ] Other
PLEASE ATTACH A BLANK COPY OF YOUR PAYROLL RECORD FORM
85
-------
^PERSONNEL RECORDS
The following questions concern what was done with personnel records under
different circumstances. The questions are repetitive, but please provide answers
to all of the questions even if the responses are the same.
1. In what form were personnel records kept? Check all that apply.
[ ] Card files
[ ] Paper files (e.g., 8 1/2 x 11 inch file folders)
Q ] Wheel file
[ J Microfilm
[ ] Computer files
[ ] Other files, specify type
2. How were personnel records on active employees organized (e.g., alphabetically
by name, by department, etc.)?
3. Which of the following items were Included in personnel records? Please check
all items that apply.
[ ] Name
[ ] Social security number
[ ] Birthdate
[ ] Birthplace
[ ] Race
[ ] Sex
[ ] Father's name
[ ] Mother's maiden name
[ ] Spouse's and children's names and addresses
[ 3 Date of hire
[ ] Date of termination
[ 3 Reason for termination (e.g., retired, disabled, discharged, died)
[ ] Work type (administrative, production, maintenance)
[ ] Work location
[ ] Current job title
[ ] Any previous job title(s) with this plant
[ ] Date of job title changes
[ ] Residence address
[ ] Employee number
4. Were any personnel records ever destroyed by accident (e.g., fire, flood)?
[ 3 No
[ ] Yes If Yes, please describe the records destroyed.
-------
5. Did you retain personnel records on former employees?
[ ] No
[ ] Yes If Yes, answer a and b below.
a. Estimate the approximate number of records you have on former
employees.
b. Estimate the approximate number of retired workers who are receiving
benefits.
c. Where are the personnel records on former employees maintained?
Questions 7-12 refer to personnel records of former employees. If you answered
no to question 5, please proceed to the section on medical records. Otherwise,
continue.
6. Retired Employees
a. What happened to the personnel records of an employee who retired from
the facility while it was in operation? (Check all that apply.)
[ ] Filed with the personnel records of current employees
C ] Stored in a separate file of former employees
[ ] Stored in a separate file of retired employees
[ ] Other
b. How were records on retired employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
C 3 By year of retirement
[ ] Other
c. Were personnel records of retired employees ever destroyed while the facility
was 1n operation?
C ] No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
d. If a retired employee died, was a copy of the death certificate obtained?
C 3 No
[ ] Yes If Yes, where was the death certificate filed?
87
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7. Employees Deceased While Employed
a. What happened to the personnel records of an employee who died while still
employed? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored 1n a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How were records on deceased employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
C ] By year of death
[ ] Other
c. Were personnel records of deceased employees ever destroyed while the
facility was in operation?
C ] No
[ ] Yes If Yes, where was the death certificate filed?
8. Employees Who Voluntarily Terminated Employment
a. What happened to the personnel records of an employee who terminated
voluntarily? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How were records on terminated employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
[ ] By year of termination of employment
[ ] Other
c. Were personnel records of employees who terminated voluntarily ever destroyed?
[ 3 No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
-------
9. Discharged Employees
a. What happened to the personnel records of an employee who was discharged?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored 1n a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b, How were records on discharged employees organized?
[ ] Alphabetically by name
[ 3 By department and alphabetically by name
C ] By year of discharge
[ 3 Other
c. Were personnel records of discharged employees ever destroyed while the
facility was 1n operation?
C 3 No
C ] Yes If Yes, how long were they retained before being destroyed?
years
10. Employees Who Were Laid Off
a. What happened to the personnel records of employees who were laid off?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
C ] Stored 1n a separate file of former employees
[ ] Eventually destroyed
[ 3 Other
b. How were records on employees who were laid off organized?
[ ] Alphabetically by name
[ 3 By department and alphabetically by name
C ] By year the employee was laid off
[ 3 Other
c. Were personnel records of employees who were laid off ever destroyed
while the plant was in operation?
C 3 No
C 3 Yes If Yes, how long were they retained before being destroyed?
years
89
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11. Disabled Employees
a. What happened to the personnel records of an employee who was disabled
while employed? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How were records on disabled employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
C ] By year that employment ended
[ ] Other
c. Were personnel records of disabled employees ever destroyed while the
facility was in operation?
C ] No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
IF POSSIBLE, PLEASE ATTACH A BLANK COPY OF THE
PERSONNEL RECORD FORM THAT YOUR FACILITY USED
90
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EMPLOYMENT APPLICATIONS
(for those who were hired)
1. In what form were employment applications kept?
[ ] Card file
[ ] Paper file (e.g., 8 1/2 x 11-inch file folder)
[ ] Wheel file
[ ] Microfilm
[ ] Computer file
[ ] Other files, specify type
2. Which of the following items were on employment applications? (Check all
that apply.)
[ ] Name
[ ] Social security number
[ ] Birthdate
[ ] Residence address
[ ] Previous work history
3. Where were these employment applications stored?
[ ] Personnel files
[ ] Separate file of applications
[ ] Other
4. Were the employment applications of former workers ever destroyed while the
facility was in operation?
C ] No
[ ] Yes If Yes, how long were they kept before being destroyed?
5. After the facility closed, were employment applications:
[ ] Kept at the facility?
[ ] Forwarded to a central repository?
[ ] Destroyed?
[ ] Other?
91
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MEDICAL RECORDS
1. Did you give pre-employment physical examinations when the facility was 1n
operation?
C 3 No
[ ] Yes If Yes, answer both a and b below.
a. When did you begin this practice?
b. Where were the examinations given?
[ ] on-s1te clinic
[ ] off-site clinic
[ ] on and off-site clinics
2. Were medical records ever destroyed while the facility was in operation?
C ] No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
3. Did you regularly collect smoking history for the medical record?
C 3 No
C ] Yes
4. What types of medical exams did you regularly conduct?
[ ] Hearing assessment
[ ] Pulmonary function
C ] General physical
[ 3 Other
5. Were the medical records kept after the plant closed?
[ 3 No
C 3 Yes
6. Are the medical records currently available?
C 3 No
C 3 Yes If Yes, where are they now? _^_^_^^^______________
92
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7. How many full-time equivalent (FTE) medical starf did you employ?
FTE Medical Staff
a. Physicians
b. Nurses
c. Technicians
IF POSSIBLE, PLEASE ATTACH A BLANK COPY OF THE PRE-EMPLOYMENT
EXAMINATION FORM THAT YOUR FACILITY USED
93
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INDUSTRIAL HYGIENE QUESTIONS
1. Did you have one or more Industrial hygiene professionals at this facility?
[ ] No
[ 1 Yes
2. Did a corporate hygienist provide service and/or consultations at your
facility?
[ J No
C ] Yes
3. Did you have a part-time or collateral duty person who did industrial
hygiene at your facility?
C ] No
[ ] Yes
4. Did anyone else provide Industrial hygiene consultation?
[ 1 No
[ ] Yes If Yes, who?
5. Did you measure work-place exposures to chemical agents at this plant?
[ ] No
C ] Yes
THANK YOU FOR TAKING THE TIME TO ANSWER THESE QUESTIONS.
94
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ATTACHMENT III
QUESTIONNAIRE
FOR
CURRENTLY OPERATING
SAWMILLS A»0 PLANING MILLS
The U.S. Environmental Protection Agency is interested in a health survey
of sawmill and/or planing mill workers for the purpose of comparing the health
status of such workers to that of creosote treatment plant workers. The purpose
of this questionnaire is to determine what kinds of employment, medical, and
industrial hygiene records are available for your sawmill and/or planing mill
and in what format such records currently exist. Employee records to be
considered are those for salaried and hourly employees. In addition, we are
interested in certain descriptive information of the mill and the makeup of
the workforce.
We recognize that record-keeping systems vary from mill to mill. This
survey is not intended to evaluate specific company systems; rather, it is
Intended to see how individual systems can be integrated for the purpose of
comparing the health of workers in sawmills and/or planing mills to the health
of workers in creosote wood treatment operation. (Questionnaires similar to
this one have been sent to creosote treatment plant operators.)
For your convenience, this questionnaire is divided into six sections.
These are:
1. Descriptive Information
2. Payroll records
3. Personnel records
4. Employment applications
5. Medical records
6. Industrial hygiene
If additional space 1s needed 1n answering any of the questions, please continue
on the back of the page or use blank sheets, specifying the question by number
and letter. 95
-------
We welcome your cements. You may write that next to specific questions
or on separate pages. Please feel free to call Lois A. Rossi at
(703) 557-1900 if you have any questions.
96
-------
DESCRIPTIVE INFORMATION
1. Company name:
Name of local facility:
Local Address:
Name(s) and address(es) of un1on(s) representing employees:
a.
b.
c.
2. What year did the sawmill and/or planing mill begin operation?
3. If the sawmill and/or planing mill was closed for any period of time,
Indicate when and why.
Years Closed Reason
a.
b.
4. If the sawmill and/or planing mill has changed ownership, give the name(s)
and address(es) of previous owner(s) and the year(s) that ownership changed:
Year Ownership
Name Address Changed
a.
97
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Year Ownership
Name Address Changed
b.
5. What kind of activities are done here?
[ ] Sawing
[ ] Planing
[ ] Logging
[ ] Other (please describe)
6. Are you aware of any chemical exposure to workers?
[ ] No
[ ] Yes If Yes, what kind of chemical exposure?
[ ] Creosote
[ ] Other (please indicate)
7. How many people do you currently employ?
8. Has the size of the workforce changed substantially since the plant opened?
C ] No
[ ] Don't know
[ ] Yes If Yes, how has it changed?
9. How many current employees are:
a. Under 30 years of age?
b. Over 50 years of age?
c. Male?
10. What is the average turnover rate of workers per year? percent
11. Has the turnover rate changed since the plant opened?
C ] No
[ ] Don't know
[ ] Yes If Yes, how has it changed?
-------
12. How many employees work 1n the following areas?
Work Area Number of Employees
a. Production
b. Maintenance
c. Administration
d. Other
13. What percent of current employees are:
a. White? percent
b. Black? percent
c. Hispanic American? percent
d. Oriental? percent
e. Other? percent
14. Have these percentages by race/ethnic background (Question 13) changed
significantly over the years that this sawmill and/or planing mill has
been in operation?
C ] No
[ ] Don't know
[ ] Yes If Yes, Indicate how they have changed.
15. Approximately what percent of employees at the sawmill and/or planing mill
work with the wood (as opposed to working almost exclusively in an office)?
percent
16. Of those employees who work with wood, how much of their average workday is
spent outdoors?
[ ] Less than half their workday.
[ ] Approximately half their workday.
[ ] More than half their workday.
17. How many of the workers that you currently employ have worked at your
sawmill and/or planing mill for:
a. Less than 2 years?
b. 2-5 years?
c. 6-10 years?
d. More than 10 years?
-------
18. Plant personnel who could be contacted by the U.S. Environmental Protection
Agency regarding this survey:
Main contact - Name
Title
Personnel and/or Benefits
Records Manager - Name
Data Processing - Name
Title
Title
_
Phone number
(
Phone number
(
Phone number
100
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PAYROLL RECORDS/ACTIVE EMPLOYEES
*
The following questions are specifically about payroll records.
1. Are payroll records stored 1n a computer file (e.g., on tape or disk)?
C ] No
[ ] Yes If Yes, what kind of computer do you have?
Model
[ ] Portable (e.g., Radio Shack Model 100)
[ ] Transportable (e.g., Osbourne, Kaypro, Compaq)
[ 3 Dedicated Word Processor (e.g., Lanier, IBM displaywriter)
[ ] Micro (e.g., Apple, IBM PC)
C
C
Mini (e.g., PDP-11)
Super-mini (e.g., VAX, IBM 4341)
Main Frame (e.g., DEC System 10, IBM 3033)
[ ] Class VI Supercomputer (e.g., CRAY, Cyber)
[ ] Other (Please specify)
2. Which of the following items are Included on computer and/or hard copy
(paper) payroll records? Check all that apply.
Computer
Record
C ]
C ]
C 3
C ]
C 3
C 3
C 3
C 3
C 3
C 3
Paper
Record
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
Items
Name
Social security number
Birthdate
Date of hire
Current job title
Current job code
Type of work (maintenance, production,
administration, etc.)
Current work location (shop, department, etc.)
Previous job titles
Employee number
3*. If a worker Is terminated (retired, discharged, etc.), 1s his record
eventually destroyed or deleted from the file?
C 3 No
[ 3 Yes If Yes, how long, on the average, 1s the record retained before
being destroyed?
101
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4. Are records on current employees sent to a central repository at periodic
Intervals (e.g., corporate headquarters)?
C ] No
[ ] Yes I Yes, how many times per year are records sent to a central
repository? times per year
PLEASE ATTACH A BLANK COPY OF YOUR PAYROLL RECORD FORM AND, IF APPLICABLE,
THE FORM USED TO GENERATE A NEW COMPUTER-BASED PAYROLL RECORD.
102
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PERSONNEL RECORDS/ACTIVE AND TERMINATED
The following questions concern what 1s done with personnel records under
different circumstances. The questions are repetitive, but please provide answers
to all of the questions even if the responses are the same.
1. In what form are personnel records kept? Check all that apply.
[ ] Card files
[ ] Paper files (e.g., 8 1/2 x 11 inch file folders)
[ ] Wheel file
[ ] Microfilm
[ ] Computer files
[ ] Other files, specify type
2. How are personnel records on active employees organized (e.g., alphabetically
by name, by department, etc.).
3. If personnel files are NOT on computer, please answer this question.
Are you planning to convert to a computer system?
C ] No
[ ] Yes If Yes, when are you planning the conversion?
4. Which of the following Items are recorded 1n personnel records? Please check
all Items that apply.
[ ] Name
C ] Social security number
[ ] Blrthdate
[ ] Birthplace
[ ] Race
C 3 Sex
C ] Father's name
C ] Mother's maiden name
[ ] Spouse's and children's names and addresses
[ ] Date of hire
[ ] Date of termination
[ ] Reason for termination (e.g., retired, disabled, discharged, died)
[ ] Work type (administrative, production, maintenance)
[ ] Work location
[ ] Current job title
C ] Any previous job title(s) with this plant
[ ] Date of job title changes
El Residence address 1
J Employee number I
-------
5. Have personnel records ever been destroyed by accident (e.g., fire, flood)?
C 3 No
C ] Yes If Yes, please describe the records destroyed.
6. Do you retain records on former employees?
C 3 No
[ ] Yes If Yes, answer a and b below.
a. Estimate the approximate number of records you have on former
employees.
b. Estimate the approximate number of retired workers who are receiving
benefits.
Questions 7-12 refer to personnel records of former employees.
7. Retired Employees
a. What happens to the personnel records of an employee who retires?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ 3 Stored 1n a separate file of retired employees
[ 3 Other
b. How are records on retired employees organized?
[ 3 Alphabetically by name
[ 3 By department and alphabetically by name
C 3 By year of retirement
[ 3 Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
,d. Are personnel records of retired employees ever destroyed?
C 3 No
[ 3 Yes If Yes, how long are they retained before being destroyed?
years
104
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e. If a retired employee dies, 1s a copy of the death certificate obtained?
C ] No
[ ] Yes If Yes, where 1s the dea Ji certificate filed?
8. Employees Deceased While Employed
a. What happens to the personnel records of an employee who dies while still
employed? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ 3 Stored 1n a separate file of former employees
[ 3 Eventually destroyed
[ ] Other
b. How are records on deceased employees organized?
[ ] Alphabetically by name
[ 3 By department and alphabetically by name
[ ] By year of death
[ 3 Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
d. Are personnel records of deceased employees ever destroyed?
C 3 No
[ 3 Yes If Yes, where is the death certificate filed?
9. Employees Who Voluntarily Terminate Employment
a. What happens to the personnel records of an employee who terminates
voluntarily? (Check all that apply.)
[ 3 Filed with the personnel records of current employees
C 3 Stored in a separate file of former employees
[ 3 Eventually destroyed
[ 3 Other
b. How are records on terminated employees organized?
[ 3 Alphabetically by name
[ 3 By department and alphabetically by name
C 3 By year of termination of employment
[ 3 Other
105
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c. If the personnel records are stored separately from current employee
records, where are they stored?
d. Are personnel records of employees who terminate voluntarily ever destroyed?
C 3 No
[ ] Yes If Yes, how long are they retained before being destroyed?
years
10. Discharged Employees
a. What happens to the personnel records of an employee who is discharged?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ 3 Stored in a separate file of former employees
[ ] Eventually destroyed
[ 3 Other
b. How are records on discharged employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
C 3 By year of discharge
C 3 Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
d. Are personnel records of discharged employees ever destroyed?
C ] No
[ ] Yes If Yes, how long are they retained before being destroyed?
years
11. Employees Who Are Laid Off
a. What happens to the personnel records of an employee who is laid off?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ 3 Eventually destroyed
[ ] Other
106
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b. How are records on employees who are laid off organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
C 3 By year the employee was laid off
[ ] Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
d. Are personnel records of employees who are laid off ever destroyed?
C 3 No
[ 3 Yes If Yes, how long are they retained before being destroyed?
years
12. Disabled Employees
a. What happens to the personnel records of an employee who 1s disabled?
(Check all that apply.)
[ 3 Filed with the personnel records of current employees
[ 3 Stored 1n a separate file of former employees
[ 3 Eventually destroyed
[ 3 Other
b. How are records on disabled employees organized?
C 3 Alphabetically by name
C 3 By department and alphabetically by name
C 3 By year that employment ended
[ 3 Other
c. If the personnel records are stored separately from current employee
records, where are they stored?
d. Are personnel records of disabled employees ever destroyed?
C 3 No
C 3 Yes If Yes, how long are they retained before being destroyed?
years
PLEASE ATTACH A BLANK COPY OF YOUR PERSONNEL RECORD FORM TO THIS QUESTIONNAIRE
107
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EMPLOYMENT APPLICATIONS
(for those who have been hired)
1. In what form are these employment applications kept?
[ ] Card file
[ ] Paper file (e.g., 8 1/2 x ll-1nch file folder)
[ ] Wheel file
[ ] Microfilm
[ ] Computer file
[ ] Other files, specify type
2. Which of the following Items are on employment applications? (Check all
that apply.)
[ ] Name
[ ] Social security number
[ ] Blrthdate
[ ] Residence address
[ ] Previous work history
3. Where are these employment applications stored?
[ ] Personnel files
[ ] Separate file of applications
[ ] Other
4. Are the employment applications of former workers ever destroyed?
C ] No
[ ] Yes If Yes, how long are they kept?
108
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MEDICAL RECORDS
1. Do you give pre-employment physical examinations?
C 3 No
[ 3 Yes If Yes, answer both a and b below.
a. When did you begin this practice?
b. Where are the examinations given?
C ] on-s1te clinic
[ ] off-site clinic
[ 3 on and off-site clinics
2. Are medical records of employees retained at the plant?
C ] No
C 3 Yes
3. Are medical records ever destroyed?
C 3 NO
[ 3 Yes If Yes, how long are they retained before being destroyed?
years
4. Do you regularly collect smoking history for the medical record?
C 3 No
C 3 Yes
5. What types of medical exams do you regularly conduct?
[ 3 Hearing assessment
C 3 Pulmonary function
[ 3 General physical
[ 3 Other
6. How many full-time equivalent (FTE) medical staff do you employ?
FTE Medical Staff
a. Physicians
b. Nurses
c. Technicians
PLEASE ATTACH A BLANK COPY OF YOUR PRE-EMPLOYMENT EXAMINATION FORM
-------
INDUSTRIAL HYGIENE QUESTIONS
1. Do you have one or more Industrial hygiene professionals at this plant?
[ ] No
[ ] Yes If Yes, please furnish the name and telephone number of the
supervisor or director of industrial hygiene.
Name Phone number
2. Does a corporate hygienist provide service and/or consultations at your
facility?
C ] No
C ] Yes
3. Do you have a part-time or collateral duty person who
does Industrial hygiene at your facility?
C ] No
[ ] Yes If Yes, please furnish his or her name and telephone number.
Name Phone number
4. Does anyone else provide Industrial hygiene consultation?
C ] No
[ ] Yes If Yes, who?
5. Do you measure workplace exposures to chemical agents at this plant?
C ] No
C ] Yes
THANK YOU FOR TAKING THE TIME TO ANSWER THESE QUESTIONS.
110
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Attachment D-2
QUESTIONNAIRE FOR SAWMILLS AND PLANING MILLS THAT HAVE CLOSED
The U.S. Environmental Protection Agency 1s interested in conducting a
health survey of current and former sawmill and/or planing mill workers in
order to compare the health status of such workers to that of creosote treatment
plant workers. The purpose of this questionnaire is to determine what kinds
of employment, medical, and industrial hygiene records still exist for your
sawmill and/or planing mill and 1n what format such records were kept. Employee
records to be considered are those for salaried and hourly employees. In
addition, we are interested in certain descriptive information on the mill and
the makeup of the workforce during the operation of the mill.
We recognize that record-keeping systems vary from mill to mill. This
survey 1s not intended to evaluate specific company systems; rather, it 1s
Intended to see how individual systems can be integrated to compare the health
of workers 1n sawmills and/or planing mills to the health of workers currently
or formerly employed in creosote wood treatment operations. (Questionnaires
similar to this one have been sent to creosote treatment plant operators.)
For your convenience, this questionnaire is divided into six sections.
These are:
1. Descriptive Information
2. Payroll records
3. Personnel records
4. Employment applications
5. Medical records
6. Industrial hygiene
If additional space 1s needed in answering any of the questions, please continue
on the back of the page or use blank sheets, specifying the question by number
and letter.
in
-------
We welcome your comments. You may write them next to specific questions
or on seperate pages. Please feel free to call Lois A. Rossi at
(703) 557-1900 if you have any questions.
112
-------
DFSCRIPTIVE INFORMATION
1. Company name:
Name of local facility:
Local Address:
Name(s) and address(es) of un1on(s) that represented your employees:
a.
b.
c.
2. What year did the sawmill and/or planing mill begin operation?
3. What year did 1t close?
4. If the sawmill and/or planing mill was closed for any period of time prior
to its final closing, indicate when and why.
Years Closed Reason
a.
b.
113
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5. If the sawmill and/or planing mill changed ownership at any time during its
history, give the name(s)"and address(es) of previous owner(s) and the
year(s) that ownership changed:
Name
Address
a.
Year Ownership
Changed
Name
Address
b.
Year Ownership
Changed
6. What kind of activities were done here?
[ ] Sawing
[ ] Planing
[ ] Logging
[ ] Other (please describe)
7. Were you aware of any chemical exposure to workers?
[ ] No
[ ] Yes If Yes, what kind of chemical exposure?
[ ] Creosote
C ] Other (please indicate)
8. How many people were employed at the mill one year before 1t closed?
Did the size of the workforce change substantially over the period of time
that the mill was operating?
C'3 No
[ ] Don't know
[ ] Yes If Yes, how did 1t change?
114
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10. One year before the mill closed, how many employees were:
a. Under 30 years of age?
b. Over 50 years of age?
c. Male?
11. What was the average turnover rate of workers during the last five years
of the mill's operation? percent.
12. Did the turnover rate change during the period of time that the mill was
operating?
[ ] No
[ ] Don't know
[ ] Yes If Yes, how did it change?
13. One year before the mill closed, how many employees were working in the
following areas?
Work Area Number of Employees
a. Production
b. Maintenance
c. Administration
d. Other
14. One year before the mill closed, what percent of the employees were:
a. White? percent
b. Black? percent
c. Hispanic American? percent
d. Oriental? percent
e. Other? percent
15. Did these percentages by race/ethnic background (Question 14) change
significantly over the years that this sawmill and/or planing mill was
1n operation?
C ] No
[ ] Don't know
[ ] Yes If Yes, indicate how they have changed.
115
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16. Approximately what percent of employees at the mill worked with the wood
(as opposed to working almost exclusively in an office)?
percent
17. Of those employees who worked with wood, how much of their average.workday
was spent outdoors?
[ ] Less than half their workday.
C ] Approximately half their workday.
[ ] More than half their workday.
18. How many of the workers who were employed at the mill one year before 1t
closed had worked at your mill for:
a. Less than 2 years?
b. 2-5 years?
c. 6-10 years?
d. More than 10 years?
19. Plant personnel who could be contacted by the U.S. Environmental Protection
Agency regarding this survey:
Main contact - Name
Title
Pnone number
Personnel and/or Benefits
Records Manager - Name
Title
Phone number
Data Processing - Name
Title
Phone number
industrial Hygiene - Name
Title
Phone number
116
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PAYROLL RECORDS
The following questions are specifically about payroll records.
1. Were payroll records stored 1n a computer file (e.g., on tape or disk)?
C ] No
[ ] Yes If Yes, what kind of computer did you use?
Model
[ ] Portable (e.g., Radio Shack Model 100)
[ ] Transportable (e.g., Osbourne, Kaypro, Compaq)
[ ] Dedicated Word Processor (e.g., Lanier, IBM dlsplaywriter)
[ ] Micro (e.g., Apple, IBM PC)
[ ] Mini (e.g., PDP-11)
[ ] Super-mini (e.g., VAX, IBM 4341)
[ 3 Main Frame (e.g., DEC System 10, IBM 3033)
[ ] Class VI Supercomputer (e.g., CRAY, Cyber)
[ ] Other (Please specify)
2. Which of the following Items were included on computer are/or hard copy
(paper) payroll records? Check all that apply.
Computer
Record
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
Paper
Record
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
C 3
Items
Name
Social security number
Birthdate
Date of hire
Job title
Job code
Type of work (maintenance, production,
administration, etc.)
Work location (shop, department, etc.)
Previous job titles
Employee number
3. If a worker was terminated (retired, discharged, etc.) while the facility
was in operation, was his record eventually destroyed or deleted from the
file?
C 3 No
[ 3 Yes If Yes, how long, on the average, was the record retained before
being destroyed?
117
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4. Were payroll records on employees sent to a central repository (e.g.,
corporate headquarters) at periodic intervals when the facility was
in operation?
[ ] No
[ ] Yes If Yes, answer a and b below.
a. How many times per year were records sent to a central
repository? times per year
b. Where is/was the central repository?
5. After the plant closed payroll records were:
[ ] Kept at the facility
[ ] Forwarded to a central repository
[ ] Destroyed
[ ] Other _^___
PLEASE ATTACH A BLANK COPY OF YOUR PAYROLL RECORD FORM
H8
-------
PERSONNEL RECORDS
The following questions concern what was done with personnel records under
different circumstances. The questions are repetitive, but please provide answers
to all of the questions even if the responses are the same.
1. In what form were personnel records kept? Check all that apply.
[ ] Card files
[ ] Paper files (e.g., 8 1/2 x 11 inch file folders)
[ ] Wheel file
[ ] Microfilm
[ ] Computer files
[ ] Other files, specify type
2. How were personnel records on active employees organized (e.g., alphabetically
by name, by department, etc.)?
3. Which of the following items were included in personnel records? Please check
all items that apply.
[ ] Name
[ ] Social security number
[ ] Blrthdate
[ ] Birthplace
[ ] Race
C ] Sex
[ ] Father's name
[ ] Mother's maiden name
[ ] Spouse's and children's names and addresses
[ ] Date of hire
[ ] Date of termination
[ ] Reason for termination (e.g., retired, disabled, discharged, died)
[ ] Work type (administrative, production, maintenance)
[ ] Work location
C ] Current job title
[ ] Any previous job title(s) with this plant
[ ] Date of job title changes
[ ] Residence address
[ ] Employee number
4. Were any personnel records ever destroyed by accident (e.g., fire, flood)?
C ] No
[ ] Yes If Yes, please describe the records destroyed.
419
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5. Did you retain personnel records on former employees?
[ ] No
[ ] Yes If Yes, answer a and b below.
a. Estimate the approximate number of records you have on former
employees.
b. Estimate the approximate number of retired workers who are receiving
benefits.
c. Where are the personnel records on former employees maintained?
Questions 7-12 refer to personnel records of former employees. If you answered
no to question 5, please proceed to the section on medical records. Otherwise,
continue.
6. Retired Employees
a. What happened to the personnel records of an employee who retired from
the facility while it was in operation? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Stored in a separate file of retired employees
[ ] Other
b. How were records on retired employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
[ ] By year of retirement
[ ] Other
c. Were personnel records of retired employees ever destroyed while the facility
was in operation?
[ ] No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
d. If a retired employee died, was a copy of the death certificate obtained?
C ] No
[ ] Yes If Yes, where was the death certificate filed?
120
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7. Employees Deceased While Employed
a. What happened to the personnel records of an employee who died while still
employed? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How were records on deceased employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
[ ] By year of death
[ ] Other
c. Were personnel records of deceased employees ever destroyed wiiile the
facility was in operation?
[ ] No
[ ] Yes If Yes, where was the death certificate filed?
8. Employees Who Voluntarily Terminated Employment
a. What happened to the personnel records of an employee who terminated
voluntarily? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How were records on terminated employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
C ] By year of termination of employment
[ ] Other
c. Were personnel records of employees who terminated voluntarily ever destroyed?
C ] No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
121
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9. Discharged Employees
a. What happened to the personnel records of an employee who was discharged?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How were records on discharged employees organized?
[ J Alphabetically by name
[ ] By department and alphabetically by name
C ] By year of discharge
[ J Other
c. Were personnel records of discharged employees ever destroyed while the
facility was in operation?
C ] No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
10. Employees Who Were Laid Off
a. What happened to the personnel records of employees who were laid off?
(Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
C J Eventually destroyed
[ ] Other
b. How were records on employees who were laid off organized?
[ ] Alphabetically by name
C ] By department and alphabetically by name
C J By year the employee was laid off
[ ] Other
c. Were personnel records of employees who were laid off ever destroyed
while the plant was 1n operation?
C ] No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
122
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11. Disabled Employees
a. What happened to the personnel records of an employee who was disabled
while employed? (Check all that apply.)
[ ] Filed with the personnel records of current employees
[ ] Stored in a separate file of former employees
[ ] Eventually destroyed
[ ] Other
b. How were records on disabled employees organized?
[ ] Alphabetically by name
[ ] By department and alphabetically by name
C 3 By year that employment ended
[ ] Other
c. Were personnel records of disabled employees ever destroyed while the
facility was in operation?
C 3 No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
IF POSSIBLE, PLEASE ATTACH A BLANK COPY OF THE
PERSONNEL RECORD FORM THAT YOUR FACILITY USED
123
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EMPLOYMENT APPLICATIONS
(for those who were hired)
1. In what form were employment applications kept?
[ ] Card file
[ ] Paper file (e.g., 8 1/2 x ll-1nch file folder)
[ ] Wheel file
[ ] Microfilm
[ ] Computer file
[ ] Other files, specify type
2. Which of the following items were on employment applications? (Check all
that apply.)
[ ] Name
[ ] Social security number
[ ] Birthdate
[ ] Residence address
[ ] Previous work history
3. Where were these employment applications stored?
[ ] Personnel files
[ ] Separate file of applications
[ ] Other
4. Were the employment applications of former workers ever destroyed while the
facility was 1n operation?
C ] No
[ ] Yes If Yes, how long were they kept before being destroyed?
5. After the facility closed, were employment applications:
[ ] Kept at the facility?
[ ] Forwarded to a central repository?
[ ] Destroyed?
[ ] Other?
124
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MEDICAL RECORDS
1. Did you give pre-employment physical examinations when the facility was in
operation?
C ] No
[ ] Yes If Yes, answer both a and b below.
a. When did you begin this practice?
b. Where were the examinations given?
[ ] on-site clinic
[ ] off-site clinic
[ ] on and off-site clinics
2. Were medical records ever destroyed while the facility was in operation?
C ] No
[ ] Yes If Yes, how long were they retained before being destroyed?
years
3. Did you regularly collect smoking history for the medical record?
C ] No
C 3 Yes
4. What types of medical exams did you regularly conduct?
C ] Hearing assessment
[ ] Pulmonary function
[ ] General physical
C ] Other
5. Were the medical records kept after the plant closed?
C ] No
[ ] Yes
6. Are the medical records currently available?
C ] No
[ ] Yes If Yes, where are they now?
125
-------
7. How many full-time equivalent (FTE) medical staff did you employ?
•5.
FTE Medical Staff
a. Physicians
b. Nurses
c. Technicians
IF POSSIBLE, PLEASE ATTACH A BLANK COPY OF THE PRE-EMPLOYMENT
EXAMINATION FORM THAT YOUR FACILITY USED
126
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INDUSTRIAL HYGIENE QUESTIONS
1. Did you have one or more Industrial hygiene professionals at this facility?
C ] No
C ] Yes
2. Did a corporate hygienist provide service and/or consultations at your
facility?
[ ] No
C 1 Yes
3. Did you have a part-time or collateral duty person who did industrial
hygiene at your facility?
C ] No
[ ] Yes
4. Did anyone else provide industrial hygiene consultation?
C ] No
[ ] Yes If Yes, who?
5. Did you measure work-place exposures to chemical agents at this plant?
C ] No
C 3 Yes
THANK YOU FOR TAKING THE TIME TO ANSWER THESE QUESTIONS.
127
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QUESTIONNAIRE FOR SAUMILLS AND PLANING MILLS THAT HAVE CLOSED
The U.S. Environmental Protection Agency 1s Interested 1n conducting a
nealth survey of current and former sawmill and/or planing mill workers in
order to compare the health status of such workers to that of creosote treatment
plant workers. The purpose of this questionnaire is to determine what kinds
of employment, medical, and industrial hygiene records still exist for your
sawmill and/or planing mill and 1n what format such records were kept. Employee
records to be considered are those for salaried and hourly employees. In
addition, we are interested 1n certain descriptive information on the mill and
the makeup of the workforce during the operation of the mill.
We recognize that record-keeping systems vary from mill to mill. This
survey 1s not Intended to evaluate specific company systems; rather, 1t 1s
Intended to see how Individual systems can be integrated £o compare the health
of workers 1n sawmills and/or planing mills to the health of workers currently
or formerly employed in creosote wood treatment operations. (Questionnaires
similar to this one have been sent to creosote treatment plant operators.)
For your convenience, this questionnaire is divided into six sections.
These are:
1. Descriptive information
2. Payroll records
3. Personnel records
4. Employment applications
5. Medical records
6. Industrial hygiene
If additional space is needed 1n answering any of the questions, please continue
on the back of the page or use blank sheets, specifying the question by number
and letter.
128
-------
Vfe welcome your comments. You may write them next to specific questions
or on seperate pages. Please feel free to call Lois A. Rossi at
(703) 557-1900 if you have any questions.
129
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130
-------
APPENDIX III
LABELING APPENDICES
131
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SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per .gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)]. i 77
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to" avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)3
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.
134
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product 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.
135
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SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, V983.
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, if not
specified in Section IV.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
136
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SlMAFY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
3
4
5
6A
6B
7
?A
?B
LABEL ELEMENT
Product name
Cbnpany name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
Where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type*
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bcnes and word
POISON (in red)
Statement of
Practical
Treatment or
first Aid
Referral
statement
Side/bade panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFT5RHED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of bade panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
*
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SGMMARY-8
ITEM
8C
9A
9B
1QA
10B
Ibc
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
for use
APPLICABILITY
All pressurized
products, others
with flash
points under
150T
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction* The words "RESTRICTED USE
PESTICIDE" nust be sane type size as
signal word.
Required statement iss
"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,
COOT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
\0
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20*F
and not over 80*F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20'F
and not over 80*F.
C. Flashpoint over 80"F
and not over 150°F.
D. Flashpoint above
150*F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130"F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130*F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
140
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions t
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.
141
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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)
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.
Plastic containers
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.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused*, dispose of in the same manner*
Paper and
plastic bags
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)
Compressed gas
cylinders
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
142
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ATTACHMENT IV-1
American Wood-Preserver's Association
Standards for
Coal Tar/Creosote Formulations
14-3
-------
AMERICAN WOOD-PRESERVERS'
STANDARD
ASSOCIATION
PI -78 (Revised)
STANDARD FOR COAL TAR CREOSOTE FOR LAND AND FRESH WATER USE
1. The creosote ;b*U be * distillate derived
catirely from tar produced by the carbonization of
. . / , * *
bltumiCOUS COal.
__ ...
2. The new creosote and the creosote in use on
... , , , „ .
treating operations shall conform to the following
detailed requirements:
New Crtoiote Otoiote ia U*c
Not
Lai
2.1 Water, percent by Vol-
t=>e - .
2"a *t'1C
24
Net
More
«i«'"S
1.3
o.j
Not Net
Lm Mere
Th»o
i.o
2 5J
355-C
New Creotou Ocoicu h U
Distillation: Tkc diitJl-
Ut«. R««« I».T *t e« *
^atw-fret buo. shall be
'4"** ** Mlo-via* lim-
Not
Leu
Thin
**
Up to jjo*c
Up to JIO'C
Up to SU'C
Up to 3J3*C
l.0
40.0
60.0
Met
More
Tban
2.0
3j'.0
«J.O
77.0
Not
Leu
Tb»«
Net
Men
Than
a.o
SJ*.0
40.0 <5.0
60.0 77.0
l.ooj
1.07J
3. Tests to establish confonnanOB with the
e . . , .. , . .
foregoing requirements shall be made in accordance
with the standard methods of the American Wood-
Preservers' Association. (See Standard Al).
: 1917, 1921, 1923, 1924, 1953.- 1933. 1934
1947> 1930> 1951' 1932> 1933f
1978.
P7-85
STANDARD FOR CREOSOTE FOR BRUSH OR SPRAY
TREATMENT FOR FIELD CUTS
1. The creosote shall be a distillate derived entirely
from tar produced by the carbonization of bituminous
coal
2. The creosote shall conform to the following de-
tailed requirements:
Net
2.1 Meiitur* p«rerat by .
2-2 Specie rr»vity tt 38* C eompwid to
w»ur at 16.8* C^..... _____ .........
2J NUltrial liueluble in Xylcnc pcrecnl by
2.4 DUtiiUrtVn".UVdlitrnVu"p^rV«ntVrVtl
eo a BoUtur»-(rM bull shall bav« Ut«
followiar Ilmiti:
Up to 210* C 7. by wt. — .........
Up to 23S* C 7, by W. ...........
Up to 3SS« C % by wt. ............
2.5 Tbi cr»o«oU ikiU b« fluid aod remain
cryiul-lrre after 9 boon at 8* C.
l.OC
(E.O
Net Mere
Tlutt
1.0
1.0
10.0
3. Tests to establish conformance with the fore-
going requirements shall be made in accordance with
the standard methods' of the American Wood-Pre-
servers' Association. (See Standard Al).
-------
P13-85
STANDARD FOR COAL TAR CREOSOTE TO BE USED IN THE TREATMENT OF
MARINE (COASTAL WATERS) PILES AND TIMBERS
1. The creosote shall be a distillate derived
entirely from tax produced by the carbonization of
bituminous coal.
2. The new creosote and the creosote in use in
treating operations shall conform to the following
detailed requirements.
Kew Cr
2.1
2J
Net
Tban
Waur. percent by Vol-
uat................. .....
Mailer Insoluble in Xy
Une, percent by Wt.
Specific Gravity at 38*C
compared vita waur at
15JrC
2J1 Wbote Cr«c*euM. l.OM
2.32 FracDOA 23S-
816-C 1.030
Sot
Men
Cr«oa«u ta UM
Net Net
U- More
Tbaa Tban
l.i
O.S
3.0
l.S
New Crcotot* CrrouMt IB DM
Kot
Net
More
Net
Tban
2.33 Frmctloo S1S-
3SS*C 1.105
2J34 Rrtldue above
ass'C i.ico ....
2.4 DUtiUatlon: Tbe dUtfl-
Ulc, peccnt by vt. en a
vaur-(r*c buia. iball be
witbJa tbt fellevine U»»
lu:
Upu>210«C . 2.
Up U>'23S*C 12.
1)pte270*C 20.0 40.
UptoSlS'C 4S.O CS.
Upto3U*C «.0 IS.
Tbaa
20.0
46.0
U.O
Net
Me.™
Tbaa
1.105 ..
1.1M ..
2.
12.
40.
C(.
71.
1.080 ...
1.030 4..
3. Tests to establish confonnance with the
foregoing requirements shall be made in accordance
•with the standard methods of the American Wood-
Preservers' Assodation (see Standard Al).
145
-------
AMERICAN WOOD-PRESERVERS* ASSOCIATION
STANDARD
P2-85
STANDARD FOR CREOSOTE AND CREOSOTE SOLUTIONS
1. The moicrid shall be i pure cod tar product, derived entirely from tar produced by the car-
bonization of bituminous cod. It may be either a cod tar distillate or a solution of cod tar in coal tar dis-
tillate.
2. The mazerid shdl conform to the following detailed requirements:
GRADt.
2.1
2.2
2.1
2.4
2.1
2.C
C-OBpaddoa: Co*J Ur
VB*...........— ....
t by
Watv: p*iwt \>y veins*...................
'Material Iiuolublc in Xylene percent by weight
Cokt R*ddu«: pwaet by Wtbt.............
Specific Gravity at Sr*C Comptrvrf «Uk n\jr
at tS.S'C
2.81. Wbolt tsatarUJ
2.62 Trarto* 216/31»*C
2.S* rraetfoa S16/lSo*C
: the dtalUaU fMraet by w«irbt
In. bull ituJl b« vltbia UM lollD
2.61
2.R
2.U
Up to 210-C
NwMaUriai
Net Net
L— Men
Thaa Tbaa
U»UrUl IB UM
M
l.OC
1.026
l.OU
UptallB'C ......................... 3(
Wot
L-«
Th»m
Kot
Wor,
M
1.0
2.0
s.o
»
1.11
s
25
2.M UptoStfC
l.M
1.021
.l.Ott
as
M
1.0
S.O
1.0
1.11
s
55
Net
Tban
70
LOT
1.02(
l.OU
34
Net
Mere
Tbaa
1.0
1.0
7.0
1.13
S
24
IB DM
Net
Tbaa
70
Net
Men
LOT
1.021
l.OU
34
M
3.0
4.0
1.12
s
2*
GRADE.
2.1 Competition: Coal ta/ dudlUU parent by
2.2
2.1
2.4
2.5
2.C
~ pveat by velum*... ................
Material Insoluble in Xytene percent by weight _
Coke RWdu«: pvrewotby vrifbt.............
Specific Gravity at JI*C Coap*n4 with wattr
at 16.6*C
2.6! WboU saUrlal
2.62 Fraetiea at/116* f
:.61 fraction 316/155*C'
by wtifbt oe, a
th* fetle«|ac
Net
Ua
TK.B
•0
1.01
1.076
l.OU
DUdtUticm: tba dUeiUU
vat« ir«e bara iball be
HmlU:
2.C1 Upt«210*C ........................
2.62 Up to 216'C .........................
2.« Uptoll6*C ......................... 32
2.64 Up to »»6*C ......................... (2
M»ur1»l
Net
Men
Tbaa
3.0
3.S
Net
l~
Tbaa
60
S
26
1.01
1.026
1.016
32
62
Net
Men
TX.B
3.0
4.6
10.0
1.11
i
26
N»* Material
Net Net
U«M Men
Thaa TKaa
Maurial IB UM
Net Set
L>M Men
Than Than
60
l.Of
LOZS
1.JI6
30
41
1.0
4.0
11.0
l.H
t
36
l.Ot
LOSS
1.0
6.0
12.0
1.14
10
41
26
3.0 Tests to establish coafonnity vith the foregobg requirements shall be made in accordance
the standard methods of the American Wood-ProermV Association, (see Standard Al)
146
-------
P12-85
STANDARD FOR CREOSOTE-COAL TAR SOLUTION TO BE USED IN THE TREAT-
MENT OF MARINE (COASTAL WATERS) PILES AND TIMBERS
1. The material shall be a pure coal-tar prod- ^T^T" KT__T*
n't derived entirely from tar produced by the car- »• sp*_s e Gravity of Fraction* »t sr c.
u>-k . , . . J. . r ' compared to -tier it 1S.6* C.:
bonization of bituminous coal. rm-Jon _»• C.-3U* c ------------ i.oao
W I>»«ioB 315» C.-5SS' C ............ 1.105
2. Composition: The material, shall be a sola- a^^^^^V^f^tc"^
tion of coal tar in coal-tai acosote. «w.««c — ........................... « i.jts
1. It shall conform to the following detailed ."• Tests to e$tablish conformance with the fore-
uiremcnts- going requirements shall be made in accordance with
^ * NotL«« N«t Men ^e standard methods of the American Wood-
Tbw Tk« Preservers* Association. (Sec Standard Al).
4. W*.Ur — percent by velua*.. ....... ...... 1.0 _____
!' o'i^ IjMoluW. bi Xjrlcnc'. p«rrcnl 1.0 3.0 i»ut U) tsotinc optnttlcni. »M»plt» of B_rf KjJudon nay fkow «,
S" P*^.8^! -.' ^^S'o"-,'-^;:^ taertu.' « «iieri«l inielubl* in Xylene u»d In e*k. naidiM. ind d*.
7. Sp^fie CraritY »J 3* C. eo«p»«« ereu- to ptretnum, of diitW»u up tt< 235* C A u»««olution
«. DbiHl»tloB« : The *lf«ju*«* »>«'SeJ"' WM of ipedficd «u«Jity »o
-------
APPENDIX IV
USE INDEX APPENDIX
149
-------
EPA Index to Pesticide Chemicals
COftL TOR/CREOSOTE
TQBLE OF CONTENTS
Site Name Page
TERRESTRIAL NONFOOD CROP ' 6
(Wood or Wood Structure Protection Treatments, Non-
domestic) 6
(Products Labeled for Pressure Treatment of Wood) 6
Wood Protection Treatment by Pressure 6
(Products Labeled for Groundline Treatment of
Utility Poles) 7
Seasoned Wood Products 7
(Products Labeled for Use in Nonpressure Treatment
Plants) 1O
Finished Wood Products 1O
Seasoned Wood Products 1O
(Products Labeled for Pole Framing, Piling Applica-
tions, and Railroad Tie Repair) 11
Seasoned Forest Products 11
(Products Labeled for Several Use Categories With
No Specific Directions for Use) 12
DOMESTIC OUTDOORS 13
(Wood or Wood Structure Protection Treatments) 13
(Products Labeled for Home and Farm Use) 13
Finished Wood Products 13
Seasoned Forest Products 13,14
Wood Treatment in Existing Buildings 14
150
Issued: 7-22-85 II-O25OO3-i
Provisional Update: 3-O6-87
-------
EPA Index to Pesticide Chemicals
•025O03 COAL TOR/CREOSOTE*
TYPE PESTICIDE; Wood Preservative, Fungicide, Insecticide
FORMULATIONS;
RTU (15%, 15.4674, 15.5%, £O%, 3O%, 35%, 38.3%, 45.62%, 46.5%, 5O%,
56.1%, 6O%, 65.8%, 66.7%, 7O%, 76%, 80%, 86%, 9O%, 94.5%, 95%,
95.5%, 96%, 97%, 98%, 98.5%, 99%, 1OO%)
GENERAL WARNINGS AND LIMITATIONS;
Precautionary Statements; Hazards to Humans and Domestic Animals
DANGER: May be fatal if swallowed, inhaled or absorbed through
skin. Causes skin and eye irritation. May cause severe burns. Do
not get in eyes, on skin or on clothing. Do not breathe vapors or
spray mist. Use with adequate ventilation. Do not take internal-
ly. Wash thoroughly after skin contact, before eating, drinking,
use of tobacco products, or using restrooms.
Additional Precautionary Statements for End Use Products
Additional precautionary/prohibition language is required on prod-
uct labels based on the intended uses of the product. There are
five designated use categories for coal tar/creosote end use prod-
ucts that require such statements.
NOTE: Observe warnings and limitations for other active ingredi-
ents on multiple active ingredient labels.
Definition of Terms;
MAI - Multiple Active Ingredient(s)
Products Labeled for Pressure Treatment of Wood
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.
Individuals must wear gloves impervious to the wood treatment formu-
lation in all situations where dermal contact with creosote is ex-
pected (e.g., handling freshly treated wood and manually opening
cy1i nder doors).
Individuals who manually open cylinder doors must wear gloves and a
respirator.
Individuals who enter pressure treatment cylinders and other relat-
ed equipment that is contaminated with the wood treatment formula-
tion (e.g., cylinders that are in operation or are not free of the
treatment formulation) must wear protective clothing {including
overalls, jacket, gloves and boots) impervious to the wood treat-
ment formulation and a respirator. Acceptable materials for protec-
tive clothing during application and handling of this product are
polyvinyl acetate (PVA), polyvinyl chloride (PVC), neoprene and NBR
(Buna-N).
••(•Coal tar/creosote includes currently registered products contain-
ing coal tar (0220O3), creosote oil (O25003), and coal tar creo-
sote (O25OO4). Where a formulation contains two of these active
ingredients, the higher percentage has been used to identify the
product(s) in the body of the report. See the Listing of Regis-
tered Products for the lower percentage active ingredient.
Iss ued: 7-22-85 11-025O03-1
Provisional Update: 3-06-87 \ 51
-------
EPfi Index to Pesticide Chemicals
COOL TOR/CREOSOTE
GENERflL MORNINGS ftND LIMITATIONS (continued)
Protective clothing must be changed when it shows signs of contami-
nation. 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
any general landfill, in the trash, or in any other manner approved
for pesticide disposal.
ftpplicators must not eat, drink, or use tobacco products during
those parts of the application process that may e'xpose them to the
wood treatment formulation (e.g., manually opening/closing cylinder
doors, moving trams out of cylinder, mixing chemicals, and handling
freshly treated wood).
Ovoid inhaling vapors. If inhalation of vapors cannot be avoided,
applicators must wear a properly fitting, well-maintained half-mask
canister or cartridge respirator which is MSHft/NIOSH approved for
polynuclear aromatics and organic vapors.
Products Labeled for Groundline Treatment of Utility Poles
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.
ftpplicators must wear gloves impervious to the wood treatment for-
mulations (e.g., polyvinyl acetate (PVft), polyvinyl chloride (PVC),
or neoprene) in all situations where dermal contact is expected
(e.g., during the actual application process and when handling
freshly treated wood).
ftpplicators must wear long sleeved shirts, long pants, and an imper-
meable apron during the application and mixing processes and all
situations where dermal contact is expected.
Work clothing must be changed when it shows signs of contamination.
Launder work clothing separately from other household laundry. Dis-
pose of worn—out work clothing and workshoes or boots in any gener-
al landfill, in the trash, or in any other manner approved for pes-
ticide disposal.
ftpplicators must not eat, drink, or use tobacco products during
those parts of the application process that may expose them to the
wood treatment formulation.
Products Labeled as Wood Preservatives for Home and Farm Use
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.
ftpplicators must wear gloves impervious to the wood treatment for-
mulation in all situations where dermal contact is expected (for
example, during the actual application process and when handling
freshly treated wood).
Spray applicators must wear protective clothing (including over-
alls, jackets, gloves, boots, and head covering) impervious to the
wood treatment formulation, and a respirator and goggles when spray-
ing.
152
Issued: 7-22-85 II-025O03-2
-------
EPft Index to Pesticide Chemicals
COflL TOR/CREOSOTE
GENERftL WARNINGS flND LIMITflTIONS (continued)
applicators who apply creosote by other application processes
(e.g., brush-other application processes (e.g., brush-on)) must
wear long sleeved shirts, long pants and an impermeable apron.
Launder work clothing separately from other household laundry.
ftpplicators must not eat, drink, or use tobacco products during
those parts of the application process that may expose them to the
wood treatment formulation.
Protective clothing must be changed when it shows signs of contami-
nation. Dispose of worn-out protective clothing and workshoes or
boots in a general landfill, in the trash or in any other manner
approved for pesticide disposal.
flvoid handling vapors. If inhalation of vapor cannot be avoided,
applicators must wear a properly fitting, well-maintained half-mask
canister or cartridge respirator which is MSHfi/NIOSH-approved for
polynuclear aromatics and organic vapors.
Do not apply where there may be direct contact with domestic ani-
mals or livestock, and where there may be contamination of food,
feed, or drinking and irrigation water.
Do not apply in interiors. Do not apply to wood intended for use
in interiors except for those support structures which are in con-
tact with the soil in barns, stables, and similar sites and which
are subject to decay or insect infestation. Interior surfaces of
the treated wood should be sealed with £ coats of an appropriate
sealer. Sealers may be applied at the installation site.
Do not apply to wood intended for farrowing or brooding facilities.
Do not apply to wood intended to be used in the interiors of farm
buildings where there may be direct contact with domestic animals
or livestock which may crib (bite) or lick the wood. This product
may be used to treat wood intended to be used in interiors of farm
buildings where domestic animals or livestock are unlikely to crib
or lick the wood, if £ coats of an appropriate sealer will be ap-
plied. Sealers may be applied at the installation site.
Do not apply to wood intended to be used in a manner in which the
preservative may become a component of food or animal feed.
Examples of such sites would be structures or containers for stoi—
ing silage or food.
Do not use this product to treat wood intended to be used for cut-
ting boards or counter tops.
Do not use this product to treat wood intended for construction of
those portions of beehives which may come into contact with the
honey.
Do not use this product to treat wood intended for use where it may
come into direct or indirect contact with public drinking water, ex-
cept for those uses involving incidental contact such as docks and
bridges.
Do not use this product to treat wood intended to be used where it
may come into direct or indirect contact with drinking water for
domestic animals or livestock, except for uses involving incidental
contact such as docks and bridges.
Wood to be treated with this product should be cut to size before
treatment. If it is necessary to saw or machine wood after treat-
ment, wear goggles to protect the eyes from flying particles and a
Issued: 7-££-85 II-0£5003-3
-------
EPA Index to Pesticide Chemicals
COOL TAR/CREOSOTE
GENERAL WARNINGS AND LIMITATIONS (continued)
dust mask to avoid inhaling sawdust from the treated wood. If oily
preservatives or sawdust accumulate on cloths, launder'before re-
use. Wash work clothes separately from other household laundry.
Contact with treated surfaces should be avoided even after the pre-
servative has dried. When handling treated wood wear long-sleeved
shirts, long pants, and impervious gloves (e.g., vinyl coated).
Wood which has been treated with this product should be disposed of
by burial or ordinary trash collection. Do not burn treated wood
in an outdoor fire or in stoves or fireplaces because toxic chemi-
cals may be produced as part of the smoke and ashes.
This product should not be used to treat wood which will be in fre-
quent or prolonged contact with skin, unless the wood will be treat-
ed with an effective sealer.
Products Labeled as Wood Preservatives for Use in Nonpressure Treat-
ment Plants
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 formu-
lation in all situations where dermal contact is expected (for exam-
ple, during the actual application process and when handling fresh-
ly treated wood).
Spray applicators must wear protective clothing (including over-
alls, jackets, gloves, boots, and head covering) impervious to the
wood treatment formulation and a respirator and goggles when spray-
ing. Acceptable materials for protective clothing during applica-
tion and handling of this product are polyvinyl acetate (PVA), poly-
vinyl chloride (PVC), neoprene and NBR (Buna-N).
Individuals who enter, clean or repair vats, tanks or other related
equipment that is contaminated with the wood treatment formulation
(e.g., tanks that are in operation or are not free of the treatment
formulation) must wear protective clothing (including overalls, jac-
ket, gloves and boots) impervious to the wood treatment formula-
tion, and goggles and a respirator.
Applicators who apply creosote by other application processes
(e.g., brush on) must wear disposable coveralls or other suitable
impermeable protective clothing.
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.
Protective clothing must be changed when it shows signs of contami-
nation. 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
any general landfill, in the trash, or in any other manner approved
for pesticide disposal.
Avoid inhaling vapors. If inhalation of vapors cannot be avoided,
applicators must wear a properly fitting, well-maintained half-mask
canister or cartridge respirator which is MSHA/NIOSH approved for
polynuclear aromatic and organic vapors.
Issued: 7-22-85 II-O25OO3-4
1 54
-------
EPA Index to Pesticide Chemicals
COOL TOR/CREOSOTE
GENERAL WARNINGS AND LIMITATIONS (continued)
Products Labeled as UJood Preservatives for Use in Pole Framing, Pil-
ing Applications, and Railroad Tie Repair
For pole framing, piling applications and railroad tie repair use
only. Not for household, farm, or nonpressure wood treatment plant
use.
For application to end cuts, bolt holes, and hardware fabrication.
Do not dilute or mix with other products. Ready for use.
Applicators must wear gloves impervious to the wood treatment formu-
lation in all situations where dermal contact is expected (for exam-
ple, during the actual application process and when handling fresh-
ly treated wood).
Spray applicators must wear protective clothing (including over—
alls, jackets, gloves, head covering, and boots) impervious to the
wood treatment formulation, a properly fitting, well-maintained can-
ister or cartridge respirator which is MSHA/NIQSH approved for poly-
nuclear aromatics and organic vapors, and goggles when spraying.
Railroad tie repair spray applicators operating a mechanized tie
sprayer (dual adzer) must wear long-sleeved shirts and long pants
or other suitable protective clothing. Applicators engaged in load-
ing or maintenance of the spray equipment or other activities which
may result in exposure to liquids, splashed or spills must wear
long sleeved shirts, long pants and an impermeable apron.
Railroad tie repair spray applicators operating non-mechanized
spray equipment must wear long sleeved shirts, long pants and an
impermeable apron, gloves and boots and head covering impervious to
the wood treatment formulation, and a respirator and goggles. ftp-
pi icators engaged loading or maintenance of the spray equipment or
other activities which may result in exposure to liquids, splashes
or spills must wear long sleeved shirts and long pants and an im-
permeable apron.
Applicators who apply by other application processes (e.g., brush-
on) must wear long sleeved shirts, long pants and an impermeable
apron.
Protective clothing, workshoes or boots and equipment must not be
taken home.
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.
Protective clothing must be changed when it shows signs of contami-
nation. Dispose of worn-out protective clothing and workshoes or
boots in a general landfill, in the trash or in any other manner
approved for pesticide disposal.
Applicators must complete an EPA approved training program.
For the pole framing, piling applications and railroad tie repair
applications the label must also state:
For sale only to pole framing, piling and railroad tie repair appli-
cators.
For sale only in 1O gallon or larger containers. A package of two
5 gallon containers is permissible.
155
Issued: 7-28-85 II-O25OO3-5
-------
Site and Pest
EPA Index to Pesticide Chemicals
COAL TOR/CREOSOTE
Dosages and Tolerance. Use. Limitations
Formulat ion(s)
/64010NA
/64O10NB
TERRESTRIAL NONFOOD CROP
(Wood or Wood Structure Protection Treatments. Nondomestic)
(Products Labeled for Pressure Treatment of Mood)
Wood Protection Treatment by
Pressure
FYAEQBB
Wood boring
insects
Wood/rot decay
From 025004
label ing:
RESTRICTED USE PESTICIDE. See
pressure treatment precautionary
— statements.
(10054 RTU) Wood protection treatment by pres-
O54774-OOOO1 sure (unpainted lumber). Regard-
less of the type of pressure
treatment used, the normal reten-
tion required for creosote is
from 6 to 12 pounds per cubic
foot. Only dry wood is satisfac-
torily treated by the pressure
process. Unseasoned wood should
first be steam conditioned, fol-
lowed by a 1 to 3 hour vacuum
period, by vapor drying, where
the vapors are condensed on the
surfaces, or by Boultonizing
where wood is heated in creosote
while under vacuum.
From O25OO4
labeling:
RESTRICTED USE PESTICIDE. See
pressure treatment precautionary
— statements.
(94.5X, 95S, Wood protection treatment by pres-
sure.
May be formulated with coal tar.
98*, 98. 5X
RTU)
OO0061-OO131
or
From O22003
labelingi
<90* RTU)
O57344-OO004
Issued! 7-22-85
156
II-O25003-6
-------
Site and Pest
EPR Index to Pesticide Chemicals
COOL TOR/CREOSOTE
Dosaoes and Tolerance. Use. Limitations
Formu1at i on < s)
/64002NA
/64OO2NB
FYftEQBB
Wood Protection Treatment by Pressure (continued)
CMP ID
From 025004
labelingi
(46. 5%,
56. 1*,
65.8*, 76*
RTU)
O57344-OOOO6
(Products Labeled for Groundline Treatment of Utility Poles)
Seasoned Wood Products
Wood rot/decay
From 0250O4
labeling:
(66.7% RTU)
011668-OO001
RESTRICTED USE PESTICIDE. See
precaut i onary st at ement s.
Wood protection treatment. Apply
to posts, fences, shingles, pil-
ings, and studdings that are
clean, dry, and Mel1—seasoned.
Preferable method of application
is by the bath process, but appli-
cation may also be made by dip,
brush, or spray. By bath, im-
merse wood in a creosote solution
that has been heated to 10O to
13O F (37.8 to 54.4 C). The tem-
perature of the solution should
be kept above 125 F (51.7 C) for
2 hours, then allowed to cool be-
fore removing wood. If 2 baths
are available, remove the wood
from the first bath at the end of
2 hours and place it in a second
tank containing unheated formula-
tion for 2 hours. ftfter 2 hours,
remove the wood and let dry 4 to
6 hours before handling. By dip,
immerse wood for 1 hour in a bath
of creosote that has been heated
to 1OO to 130 F (37.8 to 54.4 C).
Wood treated by dip must be com-
pletely peeled and thoroughly sea-
soned. By brush, heat the creo-
sote solution to 1OO to 13O F
(37.8 to 54.4 C) and flood the
heated solution over the surface
with a brush, completely filling
Issuedi 7-22-85
II-O25003-7
157
-------
EPA Index to Pesticide Chemicals
Site and Pest
COAL TOR/CREOSOTE
Dosages and Tolerance, Use. Limitations
Formalat ion(s)
Seasoned Wood Products (continued)
From 0£5004
label ing:
(98.5%, 99*
RTU)
OOO061-O0183
CMAI3
From 0£50O4
label ing:
(15%, 35*
RTU)
OOO453-00£59
Issued: 7-££-85
II-O250O3-8
all checks and defects. Apply a
second coat after £4 hours or
after the surface is dry. By
spray, apply £ coats of heated
solution (10O to 130 F (37.8 to
54.4 C>) using standard spray
equipment. Application by spray-
ing is not recommended during
cold weather.
RESTRICTED USE PESTICIDE. See
precautionary statements.
Wood protection treatment. Apply
by dipping or brushing to clean
and dry wood. Use heavy applica-
tions for field treatment until
no visible evidence of further
penetration occurs. Coverage (50
to 150 square feet per gallon) de-
pends upon surface conditions and
the type of wood grain.
Wood protection treatment. For
standing poles, dig a trench
around the pole to a depth or 12
inches in wet areas to 18 inches
or more in arid regions. Scrape
away dirt and decayed wood from
pole surface. Using a brush, pad-
dle, scoop or mechanical applica-
tor, apply a minimum coating of
1/4 inch thick (1/16 inch for 35
percent liquid-ready to use) from
the bottom of the trench to a
height of £ to 1£ inches above
the groundline depending on local
conditions. Wrap with a suitable
plastic coated paper. Alternate-
ly, apply to a suitable wrapping
material and staple the wrapper
to the pole before backfilling
the trenched area. For piling
cut-offs, apply a coating 1/4 to
l/£ inch to cut ends (1/16 inch
for 35 percent liquid-ready to
use). Poles that have been held
in storage for a prolonged period
or used poles to be relocated,
may be treated in decay vulnera-
158
-------
EPft Index to Pesticide Chemicals
COOL TOR/CREOSOTE
Site arid Pest Dosages and Tolerance. Use. Limitations
Formulation
-------
Site arid Pest
EPA Index to Pesticide Chemicals
COOL TRR/CREOSOTE
Dosages and Tolerance. Use. Limitations
Formulat ion(s)
Seasoned Wood Products (continued)
FYftEQBB
Termites
Wood boring
insects
Wood/rot decay
From O25O04
label ing:
bandage
(15% RTU)
OO1O22-OO218
RESTRICTED USE PESTICIDE. See
precautionary statements for
ground line treatment of utility
poles.
Wood protection treatment. Dig
around the pole to a depth of IB
inches. Remove dirt and decayed
wood. Apply bandage so that it
extends 3 inches above the ground-
line. Wrap bandage tightly, over-
lapping ends, then nail or staple
in place. Backfill, but not
above the top of the bandage.
Formulated with pentachlorophenol
and sodium fluoride; or aromatic
petroleum distillate, pentachloro-
phenol, and sodium fluoride.
(Products Labeled for Use in Nonpressure Treatment Plants)
/64003NB
/64OO2Nft
/640O2NB
FYPEQBB
Finished
Seasoned
Wood
Wood
Products
Products
Wood rot/decay
From 0£5O03
label ing:
(10O% RTU)
003486-00004
From O25004
label ing:
(66. 75C,
98. 556, 9954
RTU)
O11668-OO001
RESTRICTED USE PESTICIDE. See
precautionary statements for non-
pressure treatment plants.
Wood protection treatment. Wood
to be treated must be dry, season-
ed, and peeled of bark. Dip
fence posts for 1£ to 48 hours.
Apply 2 heavy coats to lumber by
brush (100 to 150 square feet per
gallon), allowing 24 hours be-
tween applications.
See single active ingredient use
patterns for groundline treatment
of utility poles, and follow pre-
cautionary statements for nonpres-
sure treatment plants.
160
Issued: 7-22-85
II-O250O3-1O
-------
Site and Pest
EPfi Index to Pesticide Chemicals
COOL TOR/CREOSOTE
Dosages and Tolerance. Use. Limitations
Formalati on(s)
(Products Labeled for Pole Framing, Piling applications, and
Railroad Tie Repair)
/64002NP
/64002NB
Seasoned Forest Products
FYfiEQBB
Mood rot/decay
See precautionary statements for
pole framing, piling applica-
tions, and railroad tie repair.
ftpplicators must complete an EPfl—
approved training program to use
these products. The products are
ready to use and for application
to end cuts, bolt holes, and hard-
ware fabrication.
Wood protection treatment. ftpply
several coats with a brush or moo
— to all surfaces of creosote pres-
(97% RTU) sure treated lumber that has been
OO3098-OO019 exposed to cutting, notching, or
dapping.
From 025004
label ing:
From 025004
label ing:
(95%, 98.5*,
99% RTU)
OO0061-OO184
or
From 025003
label ing:
(97% RTU)
OO1456-00023
CMftlj
From 025O03
label ing:
(45.62%, 50%,
60%, 70%,
80% RTU)
003008-00050
Wood protection treatment.
May be formulated with coal tar;
or 2,4-dinitrophenol, potassium
dichromate, and sodium fluoride.
Issued: 7-22-85
161
11-025003-11
-------
EPft Index to Pesticide Chemicals
COOL TflR/CREOSOTE
Site and Pest
Dosages arid Tolerance. Use. Limitations
Formulat ion(s)
Seasoned Forest Products (continued)
From 025004
label ing:
(15% RTU)
O030O8-00013
Wood protection treatment. For
machine application to ties,
transfer formulation to hopper of
application machine. Adjust
machine to apply 4.5 cubic inches
of formulation to each tie plate
area (9 cubic inches per tie).
Treated area should be completely
covered by tie-plate. For appli-
cation to other timber, remove
all surface decay and apply by
brush. Opply at a thickness of
1/8 inch, making liberal applica-
tion to checks and splits.
Formulated with sodium fluoride.
(Products Labeled for Several Use Categories With No Specific
Directions for Use)
CNo Site or Pest]
From 025004
label ing :
(98*, 98.5%
RTU)
OOO218-00132
or
From O25003
label ing :
(97% RTU)
OO 1456-00018
RESTRICTED USE PESTICIDE. See
precautionary statements for pres-
sure treatment; ground line treat-
ment of utility poles; nonpres—
sure treatment plants; pole fram-
ing, piling applications, and
railroad tie repair (not restrict-
ed); and home and farm uses.
May be formulated with coal tar.
From O25003
label ing :
(5O%, 6054,
70%, 80%
RTU)
OO 1456-00019
162
Issued: 7-22-85
11-025003-12
-------
Site and Pest
EPft Index to Pesticide Chemicals
COftL TflR/CREOSOTE
Dosages and Tolerance, Use. Limitations
Formalat ion(s)
/640O3NB
/64002NR
/64002NB
ISftSOFP
DOMESTIC OUTDOORS
(Wood or Wood Structure Protection Treat merit s)
(Products Labeled for Home and Farm Use)
Finished Wood Products
Seasoned Forest Products
FYPEQBB
Caroenter ants
Powderpost bee-
tles
Termites
Wood rot/decay
From 025004
label ing:
<3O%, 97%,
98.5% RTU)
004091-00011
CMflll
From 025003
label ing:
(86% RTU)
009957-00010
or
From 022003
label ing:
(30% RTU)
OO7234-O0018
From 025004
label ing:
(66.7%,
98. 5%, , 99%
RTU)
O11668-O0001
RESTRICTED USE PESTICIDE. See
precautionary statements for home
and farm use.
Wood protection treatment (fence
posts, poles, foundation timbers,
sills, shingles, and joists).
For ground contact wood, immerse
for 1£ to 48 hours. Or, apply at
least 2 liberal coats by brush
(100 to 150 square feet per gal-
lon), allowing to dry overnight
between coats. When treated lum-
ber is cut, apply 2 coats to the
exposed, untreated wood. Apply
full length to fence posts or at
least 10 inches above ground when
setting posts. Wood to be treat-
ed should be we11-seasoned, dry,
and free of bark and decay.
May be formulated with cresylic
acid; or creosote oil.
See single active ingredient use
patterns for groundline treatment
of utility poles, and follow pre-
cautionary statements for home
and farm use.
163
Issued: 7-22-85
11-025003-13
-------
Site and Pest
EPfl Index to Pesticide Chemicals
COOL TOR/CREOSOTE
Dosages and Tolerance, Use. Limitations
Formulation(s)
/6AOO£Nfl
/6AO02NB
/6AOOONB
INftftftCP
FYOEQBB
Seasoned Forest Products
Wood Treatment in Existing
Bui icings
Powderpost bee-
tles
Wood rot/decay
From 025004
label ing:
RESTRICTED USE PESTICIDE. See
precautionary statements for home
— and farm use.
(97* RTU) Wood protection treatment (new
OO7161-OOOO2 lumber and lumber in existing
buildings). Ppply by immersion
for 1 hour (5 to 1O gallons per
1,000 board feet); apply twice
for wood that is to have ground
contact. When immersion is im-
practical, cut out all unsound
wood 2 feet beyond any visible
signs of decay and apply £ heavy
brush coats (£00 square feet per
galIon).
ISfiSftFfl
INftftftCft
FYflEDBB
Carpenter ants
Powderpost bee-
tles
Wood rot/decay
CMOID
From 025OOA
label ing:
(1554, 15.5%,
2O* RTU)
001022-00256
RESTRICTED USE PESTICIDE. See
precautionary statements for home
and farm uses.
Wood protection treatment. Apply
to ground line area of unpreserved
fence posts and pilings following
the same general procedures given
below for treating utility poles.
Preferred application method is
by preparation of a bandage.
Deep checks or splits may be
treated by using a caulking gun.
Excavate the soil away from the
poles to a depth of about 18
inches. Remove soil and decay
from pole surface. Apply in a
I/A inch thickness or more (3/8
inch) under special conditions.
Bandages may be prepared to cover
groundline areas of poles in
bands 18 to ££ inches in height.
Opply to cover the pole surface A
inches below the last evidence of
decay and 3 inches above the
groundline. More than 1 bandage
may be used in special cases
where the pole area to be covered
spans a height greater than 22
inches, such as on hillside^.
Issued: 7-££-85
II-O£5003-1A
164
-------
EPft Index to Pesticide Chemicals
COftL TOR/CREOSOTE
Site and Pest Dosages and Tolerance. Use. Limitations
Formulat ion(s)
Seasoned Forest Products cluster (continued)
Formulated with 2 of the follow-
ing: aromatic petroleum deriva-
tive solvent, pentachlorophenol,
or sodium fluoride.
See TERRESTRIftL NONFOOD CROP, (Products Labeled
for Several Use Categories With No Specific
Directions for Use).
165
Issued: 7-22-85 11-025003-15
-------
EPO Index to Pesticide Chemicals
COOL TOR/CREOSOTE
Listing of Registered Pesticide Products by Formulation
&E15.0016 15* liquid-ready to use
coal tar creosote (O£5004>
sodium fluoride (075£0£>
003008-00013
coal tar creosote (025OO4)
aromatic petroleum distillate (OO66O1)
pentachlorophenol (063O01)
000453-00171
coal tar creosote (O25OO4)
borax or sodium tetraborate decahydrate (0111O£)
pentachlorophenol (O63OO1)
OO3008-OO015
coal tar creosote (O£50O4)
pentachlorophenol (O630O1)
sodium fluoride (075£O£)
O010££-00£56 003OO8-OO014
coal tar creosote (0£5O04)
aromatic petroleum derivative solvent (OO65O1)
pentachlorophenol (O63O01)
sodium fluoride (O75£O£)
O010££-00£18
coal tar creosote <0£5OO4)
aromatic petroleum distillate (OO6601)
borax or sodium tetraborate decahydrate (01110£)
pentachlorophenol (O63O01)
OO0453-O01O3
coal tar creosote (0£50O4)
aromatic petroleum distillate (OO66O1)
pentachlorophenol (063OO1)
sodium fluoride (O75£O£)
OOO453-00£59
&215.4616 15.46* liauid-readv to use
coal tar creosote (0£50O4)
aromatic petroleum derivative solvent (O06501)
borax or sodium tetraborate decahydrate (011102)
pentachlorophenol (O63001)
0010££-00379
&£15.5O16 15.5% liquid-ready to use
coal tar creosote (0£50O4)
aromatic petroleum derivative solvent (O065O1)
pentachlorophenol (063001)
O01O££-OO4O8
16
Issued: 7-££-85 11-0£5003-16
-------
EPO Index to Pesticide Chemicals
COOL TOR/CREOSOTE
Listing of Registered Pesticide Products by Formulation (continued)
&22O.OO16 2OX liquid-ready to use
coal tar creosote (0250O4)
aromatic petroleum derivative solvent (O06501)
pentachlorophenol (063001)
001022-00496
&230.O016 3OX liquid-ready to use
coal tar creosote (025004)
010727-00002
creosote oil (O25003)
coal tar neutral oils (0250O1)
pentachlorophenol (O630O1)
007234-00018
&235.0016 35% liquid-ready to use
coal tar creosote (025004)
pentachlorophenol (063001)
sodium fluoride (075202)
OOO453-00182 006314-OOOO1*
*jacket currently unavailable for review
&236.3O16 38.3* liquid-ready to use
coal tar creosote (025004)
creosote oil (O250O3) 38.3%
2,4-dinitrophenol (037509)
pentachlorophenol (O63001)
potassium dichrornate (068302)
sodium fluoride (O75202)
003008-OO048*
*jacket currently unavailable for review
&24S.6216 45.62% liquid-ready to use
creosote oil (O250O3)
2,4-dinitrophenol (O375O9)
potassium dichrornate (0683O2)
sodium fluoride (0752O2)
003008-00004* 0003008-OO05O
*jacket currently unavailable for review
&246.5016 46.5* liquid-ready to use
coal tar creosote (025004)
coal tar (O22OO3) 46.5%
O57344-OOOO6
&25O.OO16 50% liquid-ready to use
creosote oil (O25003)
coal tar (022O03) 47%
001456-00019 OO1456-OOO24
167
Issuedi 7-2S-85 II-O250O3-17
-------
EPft Index to Pesticide Chemicals
COftL TOR/CREOSOTE
Listing of Registered Pesticide Products by Formulation (continued)
&£56. 1O16 56. 1% liquid-ready to use
coal tar creosote (O25OO4)
coal tar (0££003) 37.4%
O57344-OO005
&260.OO16 6O% liquid-ready to use
creosote oil (0£5OO3)
coal tar (O22O03) 37%
001456-OO02O OO1456-00025
&£65.8O16 65.6% liquid-ready to use
coal tar creosote (O250O4)
creosote oil (O25OO3) 28. £%
057344-00002
&£66.7O16 66.7% liquid-ready to use
coal tar creosote (O£50O4)
011668-OOOO1
&£70.0016 7O% liquid-ready to use
creosote oil (O25OO3)
coal tar (O22O03) 27%
001456-00022 OO1456-OOO26
coal tar (O22OO3)
creosote oil (O25OO3) 30%
OO3486-OOOO1
&£76.O016 76% liquid-ready to use
coal tar creosote (O250O4)
coal tar (O22OO3) 19%
057344-OOOO3
&28O.0016 8O% liquid-ready to use
creosote oil (025OO3)
coal tar (O22OO3)
001456-00021 OO1456-OO027
.&2S6.0016 86* liquid-ready to use
creosote oil (025OO3)
cresylic acid (O221O1)
009957-0001O
&29O.OO16 9O% liquid-ready to use
coal tar (O220O3)
057344-OOOO4
&294.5016 94.5% liauid-readv to use
coal tar creosote (025004)
OOOO61-OO13O
168
Issued: 7-22-85 11-O25OO3-18
-------
EPfi Index to Pesticide Chemicals
COOL TOR/CREOSOTE
Listing of Registered Pesticide Products by Formulation (continued)
&295.O016 95% liquid-ready to use
coal tar creosote (0250O4)
OOCO61-OO131 OOOO6 1-00 185
&295. 5016 95.5* liquid-ready to use
coal tar creosote <0250OA)
000061-00133*
#jacket currently unavailable for review
&296.O016 98% liquid-ready to use
coal tar creosote (025O04)
000061-001 32*
*jacket currently unavailable for review
&297.0016 97% liquid-ready to use
creosote oil (O250O3)
OOO299-OO156* OO1456-OO018 OO1456-OO023 O1169O-OOOO1
*jacket currently unavailable for review
coal tar creosote (0250O4)
OO3O98-OOOO9 OO3O98-OO019 OO7161-OOOO2 055146-OOO2O*
*jacket currently unavailable for review
&298.OO16 98* liquid-ready to use
coal tar creosote (025004)
0002 18-OO 136 057344-00001
&298. 5016 98. 5* liquid-ready to use
coal tar creosote (025004)
OOOO61-OOO94 OOOO61-O0183 OOOO61-O0184 OOO218-OO13£
OOO218-OO6O9 002077-OO002 004O91-OOOO7 00409 l-OOO 11
&299. 0016 99?t liquid-ready to use
coal tar creosote (O250O4)
OOOO61-OOO96 000061-001 £9 OOOO61-O0186 OOOO61-OO187
&299.9916 1OO*_ liquid-ready to use
creosote oil (O250O3)
003486-OOOO4 O05351-OOO05
coal tar creosote (025004)
054774-00001
169
Issued: 7-22-85 II-025OO3-19
-------
EPA Index to Pesticide Chemicals
COOL TAR/CREOSOTE
Appendix 0-1
Listing of Active Ingredient(s) Found in Combination with the
Report Chemical
Chemical Common Name
Code (source)
O06501 aromatic petroleum derivative
solvent
O06601 aromatic petroleum distillate
011102 borax
0220O3 coal tar
OS50O1 coal tar neutral oils
0250O4 coal tar creosote
O25OO3 creosote oil
022101 cresylic acid
O375O9 2,4-dinitrophenol
063001 pentachlorophenol
O635O3 petroleum distillate
068302 potassium dichromate
O75202 sodium fluoride
— Use Common Name
EPA Acceptable
Common/Chemical Name
borax or sodium
tetraborate deca-
hydrate
Issued: 7-22-85
II-025OO3-20
170
-------
Form Approved. OMB No. 2070-0057. Approval expires 11-30-89.
EPA RE
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME DATE C
GISTRATION NO.
5UIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
Q 1. 1 will submit data in a timely manner to satisfy the following requirements. If the test procedures 1 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, 1 enclose the protocols that 1 will use:
G 2. 1 have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii)
requirements. The tests, and any required protocols, will be submitted to EPA by:
to satisfy the following data
NAME OF OTHER REGISTRANT
Q 3. 1 enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for
respect to the following data requirements:
Development of Data" with
CH 4. 1 request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
O 5. 1 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)
171
-------
OMB Approval No. 2070-0057 (Expires 11/30/89)
(Togtmify, etnlfyALL
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who art subject to Iht require-
ments of a Notioa undar FIFRA Section 3(c)(2)(B) eontainad in a Guidanoa Document
to submit data concerning the active ingredient:
BUIDAMCK DOCUMINT DAT!
ACTIVE INORIDIENT
MAMflOfPIMM
•PA
'ANY NUMMM
(This firm or group of firms is referred to below at "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are ettachid. That offer was irrtvocibli and included sn offer to b«
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(HO if final agreement on all terms could not be reached otherwise. This offer wti madt
to the following firm(s) on the following dated):
NAME OF FINN
DATE OF OFFER
However, none of those flrm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(i) 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
ma whether my firm must submit data to avoid suspension of its registration(s) under FIPRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPID NAME
EFA Form SJBMVC (10421
SIGNATURE
DATE
-------
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
Test not
1 required
If or ray
1 product
listed
above
Reg is trat ion ( check
Guideline No. Name of Test I below)
S158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
62-3 Analytical methods
for enforcement
limits
63-2 Color
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
1
I am complying with
data requirements by I
I Submit-
Iting
Data (For EPA Use Only)
(At- j Access ion Numbers
Citing MRIDf I tached) I Assigned
Dissociation
constant
Octanol/water
partition
coefficient
PH
Stability
Oxid iz ing/reduc ing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
173
-------
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Corrosion
characteristics
Dielectric break-
down voltaqe
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
174
-------
OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of generic data on the
active ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) 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 subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are .
(4) My finti will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product to one that is not registered
and purchased.
(5) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(6) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
175
EPA Form 8570-27
-------
APPENDIX VI
BIBLIOGRAPHY APPENDICES
NORE: There is no bibliography to this document. A bibliography
containing all references cited may be found in the
Agency's Position Document 2/3, January 1981, and Position
Document 4, July 1984, both available from the Office of
Pesticide Programs, EPA, 401 M St., SW., Washington, D.C.
20460.
176
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