560TS794
ted States
nronmental Protection
Office of
Toxic Substances
Washington DC
January 1979
Toxic Substances
Explanatory Appendix
Premanufacture
Notice Forms
PROTtUTu
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EXPLANATORY APPENDIX
PREMANUFACTURE NOTIFICATION FORMS
JANUARY 1979
INDEX
Part I - General Information
Section A - Manufacturer Identification
Section B - Chemical Identity
Section C - Production Marketing Data
Section D - Federal Register Notice
Section E - Schematic Flow Diagram
Section F - Attachment List
Part II - Risk Assessment Data
Section A - Chemical Properties,
Environmental Fate
Characteristics and Human
and Ecological Effects Data
Section B - Exposure From Manufacture
Section C - Exposure From Processing
Operations
Exposure From Consumer Use
Section D -
Part III - Risk Analysis and Optional Data
Section A - Risk Analysis
Section B - Structure/Activity
Relationships
Section C - Industrial Hygiene
Section D - Engineered Safeguards
Section E - Industrial Process and Use
Restriction Data
Page
2
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4
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61
63
65
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EXPLANATORY APPENDIX
This appendix is intended to provide interim guidance
concerning the information required in the forms listed
below. The following four forms were proposed in the
January 10, 1979, Federal Register, 40 CFR Part 720, Vol 44,
No. 7, page 2283 through 2348:
Premanufacture Notice Form
Processing and Consumer Use Form
Premanufacture Notice for Importers
Foreign Manufacturers/Suppliers Form
A brief explanation of the objective and information that
is required by each question in the Premanufacture Notice Form
and Processing and Consumer Use Form is provided. The explana-
tions provided for each question are applicable to the same
questions when they appear in the Importers and Foreign
Manufacturers Forms. In cases where no explanation was con-
sidered necessary, "self explanatory" has been entered
beside the question number. Detailed instructions for
completing all notice forms will be provided at the time of
promulgation of the Premanufacture Notice Rules and Forms.
Any information reported may be claimed confidential.
In addition, the information required must be reported to
the extent it is known to or reasonably ascertainable by the
submitter. If any information is not known and not reasonably
ascertainable, "NA" (Not Ascertainable) should be entered on
the form.
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PREMANUFACTURE NOTICE FORM
Part I - General Information
Section A - Manufacturer Identification
QUESTION 1: Self explanatory.
QUESTION 2: Self explanatory.
QUESTION 3: Self explanatory.
QUESTION 4: Enter the name of a company official who
may be contacted in order to answer any questions
concerning the contents of the notice.
QUESTION 5a: These questions identify other persons who
are expected to manufacture (or import to the U.S.)
the new chemical substance under an existing or planned
business arrangement. This would include any persons
who will commence manufacturing in the future (e.g.,
when production volume reaches a certain level). The
submitter must provide the address of any such persons,
explain the type of business arrangement, and estimate
the date when manufacturing will begin. In addition,
the submitter must indicate whether the responses on
the form include information related to the manufac-
turing and use activities of these persons. If the
form does not include this information the submitter
must also estimate the amount of the new chemical
substance that will be produced by such persons within
5 years after the submitter's estimated date of commence-
ment of manufacturing. This information will aid in
estimating the amount of the new chemical substance
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that will be produced in the first 5 years and
help EPA gain a more complete picture of the potential
for human exposure and environmental release.
QUESTION 5b: Self explanatory.
QUESTION 5c: Self explanatory.
QUESTION 6: Self explanatory.
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Section B - Chemical Identity
The complete and unambiguous specification of the
chemical substance identity is a necessary element of a
valid notice. Such information permits verification that
the chemical substance is "new" (i.e., that it is not listed
on the inventory of Chemical Substances) and assists in
evaluation of potential health or environmental effects.
The information required depends upon whether the
chemical substance for which a premanufacture notice is
submitted is a Class 1 substance, Class 2 substance or a
polymer. The definition of these terms is presented in
the appropriate section below.
QUESTION 1: A Class 1 substance is a chemical substance
whose composition, except for impurities, can be
represented by a definite chemical structure diagram.
Examples of such substances are as follows: 1,3-buta-
diene, benzene and sodium chloride.
QUESTION la: The new chemical substance may have an assigned
Chemical Abstracts Service (CAS) Registry Number which
can serve as a unique identifier for the chemical sub-
stance. The reporting of a substance by its prior CAS
Registry Number will expedite the verification of the
chemical substance identification. Listings of CAS
numbers are contained in several documents commonly
available in major libraries and research organizations:
The Chemical Abstracts (CA) Volume or Collective
Chemical Substances Indexes, the CA Volume or Collec-
tive Formula Indexes and the CA INDEX GUIDE.
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QUESTION Ib: Enter a name that clearly and uniquely
identifies the chemical substance being reported.
Using consistent rules of chemical nomenclature,
identify the positions of attachment of chemical
groups or of unsaturation by the use of locants,
positional or stereochemical relationships, or other
structural information; the name should contain
enough information to permit the drawing of an un-
ambiguous chemical structure diagram.
QUESTION Ic: Provide an ordered inventory or summation
of the kind and number of atoms which appear in the
molecule. For example, CgHg is the molecular formula
for benzene, C2H4C>2 for acetic acid.
QUESTION Id: Enter other common names by which the chemical
substance may be identified in the scientific or techni-
cal literature.
QUESTION le: Enter those trademarks under which the chemical
substance will be marketed or has been marketed in the
past (if known). Such trademarks need not be registered
trademarks; brand name(s) of the product must be reported
even if not registered.
Question If: The structure diagram should clearly indicate the
identity of the atoms and the nature of bonds joining the
atoms. The diagram should show spatial and stereochemical
relationships, anionic charge and other aspects of the
chemical structure. Carbon atoms in ring systems and
their attached hydrogen atoms need not be explicitly shown.
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Example:
,0
Me
O
0
QUESTION 2:
0-
ri
A Class 2 substance is a chemical substance
whose composition, except for impurities, cannot be
represented by a single chemical structure diagram.
Such substances are generally derived either from nat-
ural sources or from complex reaction products. Their
composition is sometimes poorly characterized and vari-
able in nature. Examples include chlorinated naphthalene
and the glycerol monoester of hydrogenated cottonseed
oil acids.
QUESTION 2a: See question la on page 4 of this appendix.
QUESTION 2b: The specific chemical name of a Class 2
substance must be one which is as descriptive of the
substance as possible. In some cases this name may
take a form similar to that used in describing Class 1
compounds, but indicating the substance's multi-
component nature. For example, the name polychloro-
biphenyl indicates a composition which has multiple
components with regard to both the number and the
placement of the substituent chlorine atoms. In
other cases the best possible name may only identify
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the substance as a reaction product of specified
reactants. For example, the anhydrosorbitol monoester
of hydrogenated castor oil acids.
QUESTION 2c: See question Id on page 5 of this appendix.
QUESTION 2d: See question le on page 5 of this appendix.
QUESTION 2e: To characterize a Class 2 substance fully
requires information concerning its method of prepara-
tion or its origin. For substances prepared by chemical
reactions, the description should appear in the form
of a reaction scheme.
A + B —>C
The reaction scheme should unambiguously identify, by
name and CAS Registry Number (if known), the immediate
precursor substances and the nature of the reaction.
The nature of the reaction must be as specific as
possible (e.g., acetylation, alkaline hydroysis,
diazotization). For substances which have been
produced without chemical reaction - for example, by
extraction from a natural source or reaction mass -
specify the source, the extraction process and the
nature of the extract.
A partial or incomplete structure diagram can
sometimes be drawn for a Class 2 substance. In such
cases a diagram should indicate the characteristic
structure or variable compositional elements of the
substance.
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If a manufacturer of a Class 2 chemical substance
intends to manufacture a limited range of possible
compositions of the Class 2 substance, the range must
be reported. For example, a manufacturer may file a
notice for chlorinated naphthalene and specify a com-
positional range of 20%-40% chlorine by weight. Also,
the reaction conditions, specific catalyst, or purifi-
cation process may be directed at producing a particular
compositional range. The manufacturer must provide the
range of composition in percent (by weight) for each
specific component or class of components which will be
present in the substance as it will be manufactured.
QUESTION 3a: Specify the chemical identity of a polymer in
terms of the monomers of which it is comprised. For
these purposes the term "monomer" includes any reactive
ingredients which are chemically incorporated into the
polymer structure including chain transfer, cross-linking
or terminating agents. Monomers used at two percent (by
weight) or less need not be listed.
The percent (by weight) of a monomer is the weight
of the monomer charged into the reactor expressed as a
percentage of the weight of the polymeric chemical sub-
stance manufactured. The CAS Registry Number for
monomers that are on the Chemical Substance Inventory
must be reported.
Provide the range of composition of the polymer to
be manufactured in terms of the percent (by weight), as
described above, for each monomer used. If you intend
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the notice to apply to all possible combinations of
the monomer listed, enter the term "any" next to each
such monomer. For each monomer indicate the maximum
amount in percent (by weight) that may be present as
a residual in the polymer.
QUESTION 3b: Provide the information required in question 3a
for those monomers used at two percent or less (by weight)
but which were not listed in response to question 3a above.
(Those monomers will not be considered as part of the
polymer identity for purpose of listing on the Chemical
Substance Inventory.)
QUESTION 3c: The biological activity of a polymer is
influenced by the monomers of which it is comprised
and by other aspects of the polymer's composition. The sub-
mitter must enter here those compositional restrictions
to which this notice applies. Such information may indi-
cate :
1) the minimum number average molecular
weight of the polymer compositions
proposed for manufacture;
2) any restrictions on the low molecular
weight fractions, the degree of cross-
linking, branching or other character-
istics ; and
3) aspects of the manufacturing process
which may affect the composition of the
polymer, e.g., condensation, addition,
solution polymerization, emulsion
polymerization.
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QUESTION 4: Information concerning impurities which may
contaminate a chemical substance is necessary to evaluate
the potential for adverse health and environmental effects
associated with the chemical substance. The premanufacture
regulations (§720.2) define impurities as "chemical sub-
stance which are unintentionally present with another
chemical substance."
Because impurities may affect both product performance
and safety, the identification and control of such substances
are often important considerations in the manufacture of a
chemical substance.
This question asks the submitter to list those impuri-
ties which may "reasonably be anticipated" to be present in
the chemical substance as it will be manufactured for commer-
cial purposes. Thus the submitter may be required to
estimate the composition of a substance which he may not
yet have produced. The level of detail and certainty
which can be provided in response to this question may
depend, for example, upon whether the manufacturer has
determined the feedstocks which ultimately will be used
to manufacture the commercial substance or has determined
the capability of his quality control operations. The
submitter must provide a brief narrative to explain un-
certainties in the expected composition of the commercial
substance as reported.
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The components listed as part of the chemical identity
in questions 1-3 of this section and those listed in response
to this question should account for all of the components of
the chemical substance composition.
The following should be considered in determining
those impurities which may be reasonably anticipated:
1) Chemical and instrumental analyses - Such
analyses are often performed on the chemical substance
during research and development for purposes of charac-
terizing the substance prior to its use in health or
environmental testing, to optimize product performance, or
to understand process chemistry and optimize output.
2) Manufacturing process chemistry - A con-
sideration of feedstocks, feedstock impurities, bypro-
ducts and intermediates both from the major reaction path-
way and from significant side reactions can provide im-
portant bases for concluding that certain impurities may
be present in the chemical substance.
3) Quality control operations - These will nor-
mally determine the nature and level of impurities which may
be present in the chemical substance. For example, a final
distillation or recrystallization may effectively remove many
impurities from the substance.
Impurities present must be identified as specifically
as possible. As appropriate, the identity of impurities
should be presented as -
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(i) a specific chemical identity (including CAS
Registry Number, if available);
(ii) a class or range of structures, e.g., Cg - C-^g
fatty acid salts, or polychlorinated cyclic and acyclic
hydrocarbons in the range C^ - C]_2;
(iii) a process or source description e.g.,
pyrolysis products of cellulose or coal tar residues.
The maximum percent (by weight) in the final product
must be reported for each impurity or class of impurities
described above. Avoid use of terms such as "trace" unless
such terms are fully defined.
The submitter must also indicate the maximum total
percent (by weight) of all impurities expected to be
present in the commercial product.
In some manufacturing processes the level of certain
impurities may be controlled specifically because of known
or suspected potential for adverse health or environmental
effects. Indicate such impurities by entering a check in
the box provided.
QUESTION 5: See Appendix II of the Premanufacture Notification
Requirements and Review Procedures, January 10, 1979, Federal
Register, 40 CFR Part 720, Vol. 44, No. 7, page 2278.
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Section C - Production and Marketing Data
QUESTION 1; To estimate production and sales enter the
digit which corresponds to the appropriate production
and sales range according to Table A of this appendix.
If the production range is exactly equal to the upper
end of a range, enter the next higher code digit.
QUESTION la; The "first year" corresponds to the first one-
year period (e.g., June 1980 - June 1981) following the
"intended date of commencement of manufacture for non-
exempt purposes."
QUESTION Ib; The "third year" corresponds to the third one-
year period following the "intended date of commencement
of manufacture for non-exempt purposes."
QUESTION lc; "Maximum annual demand" is the maximum pro-
duction and sales that the chemical is expected to achieve
for a one-year period. The figures provided for the first
and third years might only reflect near term production
and sales estimates. Maximum annual demand is requested
for those situations in which the manufacturer can estimate
longer term production and sales volumes. The objective
of this question is to obtain a rough measure of the overall
potential impact of the substance.
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TABLE A
CODE
PRODUCTION AND SALES RANGES
DIGIT
POUNDS
KILOGRAMS
0 to 1,000
0 to 454
1,000 to 10,000
454 to 4,540
10,000 to 100,000
4,540 to 45,400
100,000 to 1 million
45,400 to 454,000
1 million to 10 million
454,000 to 4.54 million
10 million to 50 million
4.54 million to 22.7 million
50 million to 100 million
22.7 million to 45.4 million
100 million to 500 million
45.4 million to 227 million
500 million to 1 billion
Over 1 billion
227 million to 454 million
Over 454 million
X
No manufacture or sales is planned during that year
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QUESTION 2; This question requires an explanation of the
basis for the production estimates reported by the sub-
mitter.
"Firm order" is defined as an existing contract,
license or business agreement.
"Forecast" is defined as an estimate based on
marketing analysis or experienced judgment by management
personnel.
"Speculative" is defined as an estimate based
primarily on speculation and to which management
would attach a low probability.
QUESTION 3; Use information provides one means of assessing
potential exposure to a chemical substance. The submitter
must list all uses for which he intends or expects to
manufacture the chemical substance. The uses must be
listed in descending order, with the use that will require
the largest production volume listed first. Use data are
also requested in other sections of this form in combina-
tion with volume estimates and exposure information. These
questions will be discussed later. All uses reported else-
where on the form must also be reported here.
QUESTION 3a: In describing the use(s) of a chemical substance,
the manufacturer must report both its function(s) and
application(s) .
A chemical's function is related to its inherent
physical and chemical properties. For example, a chemical
may be an ultraviolet absorber, a degreaser, a catalyst, or
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a plasticizer - all of which are "functions" as the term is
used here. "Application" relates to the use of the chemi-
cal in particular processes or products. For example, a
chemical may be used as an ultraviolet absorber in indus-
trial plastic resin compounds or in fabricated plastic
products for industrial and consumer uses. Both of these
constitute "applications." Degreasers may be used in
various applications; for industrial cleaning of fabricated
metal parts, in automotive maintenance, or for surface
cleaning and conditioning. In most cases each function
will have more than one application.
Functions and applications can sometimes be described
by a single word or phrase (e.g., function: antifreeze,
intermediate, chain stopper (polymerization), curing agent;
applications: paint used in automotive finishes, plastic
forming compounds, building construction). The information
on application should be presented by function, i.e., for
each function list the possible applications on which your
production estimates are based.
( Note: EPA is currently developing a use list which
describes uses by function and application. This list
will provide a language or systematic terminology to
facilitate reporting of uses by industry and understand-
ing by the government. The Agency is considering using
this list as a form of guidance or requiring that use informa-
tion be recorded in accordance with the terms and codes
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contained in the list. If the list is not available
upon promulgation, use information would still be reported
using the concepts of function and application.)
QUESTION 3b: This question is designed to identify the uses
of the chemical substance that are possible but for
which the manufacturer does not presently intend to pro-
duce the chemical. The manufacturer must indicate all
possible uses which the substances may reasonably serve.
QUESTION 3c: Self explanatory.
QUESTION 3d: "Site of manufacture" means a contiguous pro-
perty unit where the chemical substance is manufactured.
This includes all factory, storage, and warehouse settings
at the site. (See §720.2 of the Premanufacture Notification
Rules for the definition of "site".)
QUESTION 4: These questions require information on past
production and regulatory action concerning the new
chemical substance. A previously manufactured or im-
ported substance may be "new" (i.e., not on the inventory)
for several reasons. The substance may have been manu-
factured or imported (1) piior to 1975, (2) solely for a
non-TSCA purpose (e.g., a pesticide), (3) solely in small
quantities for R&D purposes, or (4) may have been manu-
factured abroad and not imported into the U.S. for a
non-exempt commercial purpose. Knowledge of information
on such uses of the chemical will be valuable to EPA because
past experience may aid in determining the potential risks
associated with its manufacture and use.
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QUESTION 4a: Check whether (to your knowledge) the
new chemical substance has been manufactured within
the United States or any other country prior to the
submittal of this notice.
If you know the substance has been manu-
factured before, provide an estimate of the average
annual domestic production volume or import volume
if the chemical was manufactured in a foreign country.
Use the same production ranges used to report produc-
tion volume (page 14 of this Appendix). In addition,
estimate the total number of years the chemical substance
was produced or imported.
QUESTION 4b: Check whether (to your knowledge) the new chemical
substance is or has been subject to any domestic or foreign
restrictive regulations based on potential adverse health
or environmental effects. Restrictive regulations include
regulations that (1) limit the amount that may be produced,
(2) ban the manufacture in any country or other governmental
jurisdiction, (3) prohibit certain uses or types of uses,
(4) limit the amount of the chemical that can be discharged
to the environment from industrial sites, (5) limit methods
of disposal of the substance or materials that contain the
substance, (7) limit workplace exposure to the substance, or
(8) require that a warning label be affixed to any container
of the substance or article containing the substance.
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If you have checked "yes" in question 4b provide
the following information:
1. The country in which the chemical is
regulated,
2. the name of the governmental entity that
regulated the chemical, and
3. the citation for the regulation
QUESTION 5; Self explanatory.
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Section D - Federal Register Notice
The objective of this section is to obtain information
that will be published in the Federal Register, within 5
days after EPA receives a premanufacture notice, in accordance
with Section 5(d)(2) of the TSCA. Much of the information
required in this section is also required in other parts of
the notice. However, this section has been included separately
to assist in timely publication of the Federal Register notice.
Do not report any confidential information in this part of the
form.
QUESTION 1: Self explanatory.
QUESTION 2a: Function and application are defined on page
15 of this appendix. "Industrial use" is defined as
use at any factory, storage or warehouse site (e.g.,
intermediate, industrial solvent). "Consumer use"
includes use at all other sites and exposure to the
chemical substance at all other sites. For example,
use of a chemical substance as an adhesive by professional
carpet installers, in commercial building construction
or by the general population would all be consumer uses.
QUESTION 2b: The manufacturer must report each use so as to
describe exposure related information, if possible. For
example, include information concerning potentially exposed
populations, the proximity of the user to the substance,
and the physical state of the substance upon use (e.g.,
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aerosol consumer product used in the home). Industrial
use and consumer use are defined in the previous question.
QUESTION 3j_ The objective of this question is to identify
the types and sizes of the populations that may be exposed
to the new chemical substance. Estimate the numbe •
workers, consumers, and persons in the vicinity of manu-
facturing or processing operations that may be exposed to
the new chemical substance using the ranges given in this
explanation. The submitter must include all manufacturing,
processing and consumer uses when developing these estimates.
The code number for the appropriate range should be entered
on the form.
The submitter must consider all air emissions and water
discharges from manufacturing and processing operations when
deciding if a potential exists for general population exposure
in the vicinity of such operations. (The vicinity of manufac-
turing or processing operations includes a 5-mile radius
surrounding the site.) If the new chemical substance
is not released to the environment, there will be no general
population exposure resulting from such operations. Con-
versely, if emission to the air, water or land do occur, a
potential will exist for such exposures. It is recognized
that a very low level of release will probably result in
extremely low or undetectable levels of exposure. In such
cases the submitter should consider the location of the
site, the proximity of the general population and the
magnitude of the release in deciding if it is reasonable
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to expect that exposures may occur. If exposures are
believed to be possible, even at extremely low levels,
the submitter should check "yes" and explain the type
of exposure in question 4 using the following popula-
tion ranges:
WORKERS
CODE NUMBER OF WORKERS EXPOSED
0
1
2
3
4
10-100
100-1,000
1,000-10,000
>10,000
POPULATION
CODE
0
1
2
3
4
5
NUMBER OF PERSONS EXPOSED
< 10,000
10,000-100,000
100,000-1,000,000
1,000,000-10,000,000
10,000,000-100,000,000
MOO,000,000
Note: The EPA Support Document - Premanufacture
Notification Requirements and Review Procedures, January
1979, p. 70, states that estimates of the number of workers
and other persons exposed entered in this question should be
reported using the ranges developed elsewhere in the form for
general population exposure to consumer products; this state-
ment is incorrect. The ranges listed above should be used in
this question for estimating the number of persons exposed.
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QUESTION 4; The duration and frequency of exposure must
be quantified as specifically as possible. For example,
exposure to the general population upon use may occur
15 minutes per day, 200 days per year. The maximum level
of exposure (or magnitude) must also be quantified if
possible. If exposure levels cannot be quantified, the
submitter should describe the circumstances which affect
the level of exposures as fully as possible without re-
vealing confidential information. This would include the
place(s) that exposure may occur, the proximity of the user
to the substance, and any particular characteristics of
the substance which affect the routes of human exposure
or environmental release (e.g., highly volatile).
QUESTION 5: The objective of this question is to determine
what the total environmental release of the new chemical
substance will be at different points in its life cycle.
If the chemical substance is altered or destroyed during
its life cycle, the ultimate release may be significantly
less than 100%. For example, an intermediate which is
totally consumed during a processor's operations might
have the following releases:
Activity Percent Release
Manufacturing/Processing
Operations .0%
Industrial Disposal .1%
Consumer Use 0
Consumer Disposal 0
On the other hand, a consumer product may have the following
release:
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Activity Percent Release
Manufacturing/Processing
Operations .0%
Industrial Disposal .1%
Consumer Use 99%
Consumer Disposal .4%
Example: Detergent
QUESTION 6: Self explanatory.
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Section E - Schematic Flow Diagram
A schematic flow diagram of a manufacturing or pro-
cessing operation is a graphic and pictorial representa-
tion showing -
(1) The coordinated sequence of chemical
conversions (unit processes) and unit operations;
(2) The types of equipment employed in each
chemical conversion and unit operation;
(3) The feedstock (s), intermediate(s), byproduct(s),
co-product(s), and new chemical substance used and
produced at each chemical conversion and unit
operation; and
(4) The points where feedstock(s), intermediate(s),
byproduct(s), co-product(s), and the new chemical
substance input, output, and release into the work
place or environment (air, land, water) at each
chemical conversion and unit operation.
Chemical conversion or unit process involves the
basic chemistry of a particular reaction and the equipment
in which the reaction takes place.
•~\
Unit operation includes the physical changes of sub-
stances and the equipment in which the changes take place.
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HYPOTHETICAL EXAMPLE
A new thermosetting, synthetic resin called "new chemi-
cal substance E (Sub-E)" is to be manufactured in batch with
a non-thermosetting resin called co-product F (Co-F). The
reaction involves several chemical feedstocks (Feed-A,
Feed-B, Feed-C, and Feed-D), one chemical intermediate H (Int-H)
and two catalytic intermediates (Cat-X, Cat-Y). Byproducts
produced in the operation are water (By-W) and chemical
substance G (By-G).
Using the above example, a schematic flow diagram
outlining the sequences of chemical conversions
and unit operations would be reported as follows:
Reactions:
New Chemical Substance E Reactions: Condensations and
Polymerizations
Step 1: Feed-A and less than an equal molar amount of Feed-B
(Feed-A> 1: Feed-B-1) are reacted with any acid catalyst but
generally Cat-X.
Feed A + Feed B >• Co-F + By-W
Step 2: Co-F is reacted with an excess of Feed-C (Feed-C> 1:
Co-F-1) in the presence of any base catalyst but generally
Cat-Y.
Co-F + Feed C > Int-H + By-G + Feed-C
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Side reaction: If By-G is not removed via distillation
during the Step 2 reaction and becomes slightly excess
( greater than 1%) it will consume a monomer functional
group limiting the molecular weight of the polymer.
Feed-C + By-G *• By-G1
Step 3: Int-H is reacted with an equal molar amount
of Feed-D (lnt-H-1: Feed-D-1) to form Sub-E.
Int-H + Feed-D »• Sub-E
Chemical Conversions and Unit Operations
The three- step scheme is represented in Figure 1
showing the sequences of unit operations (Op) and chemical
conversions (Ch):
(1) The Feed-A and Feed-B are manually placed in the
reaction kettle with Cat-X. The reactants are
mixed 3 or 4 hours at a temperature of 285 to
325 F and a reduced pressure of 20 or 30 mm (Ch).
( 2) During the condensation, reaction water (By-W) is
eliminated and forms the upper of two layers.
This water of reaction and some Co-F carryover
(approximately 0.01 Ib Co-F carryover per 100
Ib Co-F produced) is removed by vacuum without the
addition of heat and discharged to the sewer without
treatment (Op). Gases (air, water vapor but no de-
tectable Co-F vapor) from the vacuum pump are
vented to the work place (Op).
(3) The warm, dehydrated, viscous Co-F resin is pumped
out of the kettle through a divider box where it
is split into two process streams. Fifty percent
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Co-F becomes feedstock in the production of Sub-E
and 50% is pumped into shallow trays and allowed
to cool and harden.
( 4) The cooled, brittle Co-F resin is broken by hand
emitting Co-F dust to the air (approximately 0.01
Ib Co-F dust per 100 Ib Co-F produced). The broken Co-F
resin is then fed into a crusher followed by a
high-speed hammer mill (Op). Crusher and hammer
mill emit 0.1 Ib Co-F dust per 100 Ib Co-F produced.
Workers in these areas are protected from Co-F
dust by use of dust masks and goggles.
(5) The finely ground Co-F resin is then mechanically
passed through a 200-mesh screen and automatically
packaged (Op). Dust from the screening and packaging
operation is 0.01 Ib Co-F dust per 100 Ib Co-F produced
(Op). The Co-F dust from these operations is removed by
a central vacuum system and reentered at the head of the
screening process.
( 6) The remaining, hot Co-F resin and Feed-C are pumped
into another reaction kettle with Cat-Y and heated
at a temperature of 270 to 280 F while kettle pressure
is allowed to build to 250 psi (Ch). After a few hours
(1 to 2 hr), the pressure is released and the mixture
is heated under reduced pressure (Ch).
(7) While reacting under reduced pressure a low molecular
weight alcohol By-G is distilled off (Op). The By-G
is used as feed for the biological treatment of the
plants domestic wastewater prior to discharge to
28
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a nearby stream. Approximately 90 Ib of By-G
is produced per 100 Ib Sub-E.
(8) The resulting hot Int-H resin is run out of the kettle
by gravity and reacted in a high-speed mixer
with Feed-D (Ch). The Feed-D is metered into the
mixer by centrifugal pump (Op).
(9) The Sub-E slurry is pumped into a storage tank and
further reacted on steam-heated rolls (Op and Ch).
(10) The Sub-E slag is dropped onto a cooling conveyor
before passing through a low-speed cutter and mesh
screen. The Sub-E dust emitted from the conveying,
cutting and screening operation is approximately
0.1 Ib Sub-E dust per 100 Ib Sub-E produced. This
dust is collected by a central vacuum system and is
reentered at the head of the cutting operation (Op).
(11) The ground, thermosetting Sub-E resin is placed in
a ribbon blender via conveyor and then automatically
packaged (Op). The Sub-E dust from the blending and
packaging operation is approximately 0.01 Ib Sub-E
dust per 100 Ib Sub-E produced. The conveying, blend-
ing, and packaging operation is not connected to the
central vacuum system; Sub-E dust is removed by pro-
tected worker (mask and goggles) with manual shop
vacuum. The collected dust is reentered at the head
of the blending operation (Op).
29
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Mass Balance:
To manufacture 100 Ib of Sub-E resin requires:
(1) Feed-A 84 Ib.
(2) Feed-B 54 Ib.
(3) Cat-X .2 Ib.
(4) Co-F 96 Ib. (50% product; 50% reacted with Feed-C),
(5) By-W 42 Ib.
(6) Feed-C 190 Ib. (excess, approx. 94 Ib. unreacted),
(7) Cat-Y .1 Ib.
(8) Int-H 54 Ib.
(9) By-G 90 Ib.
(10) Feed-D 46 Ib.
30
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Won- thermo-
1 setting resin
<-\>-F. , •!
V
St. ^J
0 3
u -o
4^
; " ~]
31
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Section F - Attachment List
This section requires the submitter to list all docu-
ments that have been attached to the notice. This listing
will allow EPA to assure that the notice is complete. Each
attachment should be numbered. This list should include the
number and title or brief identifying description of the
attached document. For example:
001 - Acute toxicity test data
002 - Mutagenicity test data
003 - Summary of environmental effects data
32
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Part II - Risk Assessment Data
Section A - Chemical Properties, Environmental Fate
Characteristics and Human and Ecological Effects Data
QUESTION 1; This question provides EPA with a concise
list of the property (ies ), characteristic (s) , or effect(s)
for which information was reported and the specific test-
ing techniques or methodology of a given test. The list-
ing of the test technique methodology should be as specific
as possible. For example, tests for point mutations should
include the species used accompanied with specific protocols.
Protocols should be cited where possible. The following is
an example of the proper completion of the Table.
TABLE 1 - PHYSICAL/CHEMICAL PROPERTIES
(1) data submitted
(2) description submitted
(3) literature citation
Property
(1) (2) (3)
Spectra (ultraviolet, [ ] [ ] [ ]
visible, infrared)
Density [X] [ ] [ ]
Solubility in water [X] [ ] [ ]
Melting point [ ] [ ] [ ]
Boiling point [X] [ ] [ ]
Sublimation point [ ] [ ] [ ]
Vapor pressure [X] [ ] [ ]
Dissociation constant [X] [ ] [ ]
Particle size [ ] [ ] [ ]
distribution
Test Methodology
or Technique
CIPAC MT3
Mader and Grady(1972)
ASTM(30)E324
ASTM D-287970
potentiometry
33
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HEALTH AND ENVIRONMENTAL EFFECTS DATA
(1) data submitted
(2) description submitted
(3) literature citation
Effect
Acute animal effects
Genetic effects
Subchronic
Teratogenicity
Reproductive effect
Oncogenicity
Other health effect
(chronic or latent
animal effects)
Microbial effects
Aquatic inverte-
brate effects
(1) (2) (3)
[X] [ ] [ ]
[X] [ ] [ ]
[X] [1 [ ]
[ ]
Test Methodology
or Technique
Oral lethality
Primary eye
irritation
Point mutation
"Salmonella Typh."
bacteria
Oral Toxicity
[ 1
[X] [ ] [ ]
[X]
[ ]
[ ]
Reproductive cycle
toxicity test
Plant effects [ ] [ ]
Fish effects [X] [ ]
QUESTION 2; This question requires the submitter's con-
96 hr. LC50 (static)
clusions and assessments concerning the expected utility
and implications of the data that have been submitted.
For example, the submitter may describe a 96-hour fish
LC50 test as an early warning indicator of potential
ecological damage or the submitter might consider a
cytogenetic test for chromosomal aberration to be
indicative of the substance's potential mutagenicity
and carcinogenicity in man. The submitter should discuss
any conclusions he has made concerning the data or descrip-
34
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tions of data submitted. (For example, do the results
indicate positive effect, negative effect or are they
inconclusive?)
QUESTIONS 3&4; Evaluations of risk include any assessments,
conclusions or analyses of the potential health or environ-
mental risk presented by the chemical substance or substances
associated with its manufacture, processing, distribution
in commerce, use and disposal of the chemical substance.
This question considers risk in the broadest sense and
affords the submitter great latitude in responding. The
submitter must provide any analyses he has performed
of the toxicity of the substance, the potential for expo-
sure to the substance and other factors which bear upon
the risks.
QUESTION 5: The objective of this question is to
assess the adequacy of data submitted in characterizing
the ability of the new chemical substance to cause any
effect for which data has been submitted. The submitter
is required to provide such an analysis if it is available.
35
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Section B - Exposure From Manufacture
Enter the name and street address of the manufacturing
site. Do not enter a mailing address if it is different from
the street address. This information will permit EPA to
determine the population density surrounding the site and
through the use of climatological and topographical factors
to assess the potential general population exposure. In
addition, it will enable EPA to obtain further information at
a later date.
The objective of the questions contained in this section
is to provide an estimate of the magnitude, duration and fre-
quency of exposure to the chemical substance that may occur
during manufacture.
QUESTION la: Check the routes by which worker exposure to the
new chemical substance will likely occur during any phase
of manufacture. This includes human exposure that may
occur during operations such as (1) material handling,
(2) maintenance of manufacturing equipment, (3) cleaning
of manufacturing equipment, (4) sampling of production
streams, and (5) general worker exposure that may occur
as a result of release of the new chemical substance into
the work place (e.g., fugitive emissions). In determining
if exposure will occur by a given route the submitter
should assume maximum exposure potential under normal
operating conditions and practices and he should rely on
past experience concerning the incidence of human exposure
in similar manufacturing operations. The maximum number
36
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of workers likely to be exposed to the new chemical
substance in a one-year period through each route must
be estimated. For example, if skin contact is expected
to occur, the maximum duration and maximum frequency of
such exposures must be estimated for a one-year period.
The submitter must provide the most detailed estimates
of the duration and frequency of exposure that are avail-
able. These may range from the maximum number of days
per year that such exposures may occur to each daily
exposure and the frequency of exposure during each day.
The magnitude of skin contact must be quantified if
possible. However, if such a quantification is not
possible, the submitter should describe such exposure
qualitatively in terms of the operations that produce them.
For example:
"The major activities that are expected to result in
skin contact are cleaning of the reaction vessel and
its components. The cleaning operation will be conducted
by two workers wearing rubber gloves, eye protection and
overalls. Skin contact will normally occur as a result
of failure of rubber gloves or any spattering of the
chemical substance that may contact exposed body areas
such as the wrists or face. The normal area of contact
would be limited to a portion of the hand and very minor
dermal contact in the head or face area. The overall area
of contact is expected to be no greater than 10 square
inches."
37
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In a similar fashion, if inhalation is expected,
it also must be quantified or explained. However, if
question Ib is completed, inhalation exposure is not
required to be quantified or explained in the response
to this question.
QUESTION Ib: This question requires estimates of the
ambient level of the new chemical substance that will
be present in the workplace air. Two types of levels
are required: 1) a time-weighted average for an 8-hour
day, 40-hour workweek schedule, and 2) a peak concen-
tration in air for 15 minutes. In addition, these
levels may be reported for two types of exposure
situations: 1) direct, and 2) ambient workplace air.
The time-weighted average levels that are reported may
include excursions above the reported levels, but these
excursions should be compensated for by equivalent
excursions below the level during the workday. This
concentration should be calculated based on an 8-hour
workday, 40-hour workweek schedule. However, if exposures
will occur for less than 8 hours per day or less than
40 hours per week because the plant will not be operating
for that duration, the concentration levels reported
should be averaged over the actual duration of exposure
which is required in question le. The maximum time-
weighted average that is calculated for each exposure
situation should be reported. Similarly, the peak con-
centrations that are reported should be the maximum
38
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average concentrations that will not be exceeded during
any 15-minute period for each exposure situation.
"Direct" exposure refers to exposures to the new chemical
substance at the highest level (greatest magnitude) that
workers may encounter in selected activities. For
example, the cleaning of the manufacturing and storage
equipment and direct handling of the chemical substance
might potentially involve direct exposure. Exposure
to "ambient workplace air" refers to less extreme
concentrations to which workers may be exposed within
the boundaries of the factory, storage or warehouse site.
QUESTION Ic: The objective of this question is to determine
the submitter's basis for arriving at the exposure
estimates he has reported in questions la and Ib, and thus
to gain an understanding of their degree of reliability.
The submitter must discuss the factors considered (e.g.,
release data from similar operations, underlying
assumptions), the methodology used and, where appropriate,
report the actual modeling and calculations that were
performed. Uncertainties in these estimates should also
be discussed.
QUESTION Id: The objective of this question is to determine
whether the analytical capability exists to detect the
new chemical substance in air, and if so, what is the
lowest level at which the substance can be detected and
39
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the 95% confidence limits of this measurement. In
addition, the submitter must describe briefly the analy-
tical methods and sampling techniques (e.g., equipment
used, sampling locations) which can be used to detect
the substance.
QUESTION JLe: "Direct" and "Ambient" are defined in question
Ib. The maximum number of days per year may vary
considerably between batch and continuous operations.
For example, a batch process may operate only five days
per year, whereas a continuous process may operate 100
days per year. The submitter must use the following
ranges and codes when estimating the maximum number of
workers exposed to the new chemical substance.
Code Number of Workers Exposed
0 <10
1 10-100
2 100-1,000
3 1,000-10,000
4 >10,000
QUESTION 2a: This question asks for estimates of the amount
and concentrations of the new chemical substance that
may be released to the air or water during its manu-
facture. The information is required for each site
where the new chemical will be manufactured so that
an accurate assessment can be made of the potential for
such releases to cause environmental effects or
exposures to the general public.
40
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Table 2 in the Premanufacture Notice Form provides
the format that must be used to report the information
required by question 2a. Since, in the majority of cases,
exact estimates of discharge rates and concentrations will
not be available, ranges of these parameters are provided.
The submitter must estimate the highest range which he be-
lieves will represent the actual values of such parameters
for the manufacturing operation. All estimates provided
must be based on normal operating conditions. Estimates
of mass release rates (kg/hr-air, kg/day-water) and con-
centrations in air emission streams and water effluent
streams should be reported for an average and maximum
release rate. This should be done by entering A (average)
or M (maximum) in the appropriate range bracket. For
example, the following estimates should be reported for
the release of the new chemical substance to the air:
[A] the average amount (kg/hr) released from the
entire site;
[M] the maximum amount (kg/hr) released in one hour
from the entire site;
[A] the average hourly concentration in each process
air emission stream;
[M] the maximum hourly concentration in each process
air emission stream.
The same estimates must be reported for release of the
chemical substance in water effluent streams based on a
24- hour time period.
41
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Release estimates from an entire site should cover
all releases including those air emission and water effluent
streams for which concentrations are reported elsewhere. Air
emissions of the new chemical substance from an entire
site would include release from sources such as:
1. continuous process emission streams;
2. relief valves;
3. evaporation from storage and transfer
operations,
4. fugitive releases from valves, pumps, or
flanges, shaft seals, compressors, etc.
5. intermittent releases from any process
operation (e.g., opening of reaction
vessels), and
6. evaporation from any water effluent treatment
process.
Stack parameters must be reported for each process
emission stack. These parameters are; (1) the diameter
of the stack at the exit, (2) the stack height, (3) the
velocity of the stack gases, and (4) the temperature of
the stack gases. These data may be used with air
pollution diffusion models to calculate ground level
concentrations of the new chemical substance around the
manufacturing facility.
The concentration of the new chemical substance
in water effluent streams (e.g., backwash from process
lines and pipes, rinseates from formulation tanks and
42
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reaction vessels, process overflow) should be the con-
centrations immediately prior to discharge into the
receiving water body or sewer if discharges are to a
publicly owned treatment work (POTW). If the new
chemical substance will be discharged in a combined
effluent stream, concentration estimates should be
based on site operating conditions that would produce
the maximum average concentrations of the new chemical
substance.
The minimum detectable level of the new chemical
substance in air emission streams and water effluent
streams, the method of detection, and the 95% confidence
limits of this measurement must be reported. This level
may be based on the submitter's knowledge of methods
developed during the research and development phase.
In addition, the composition of the air emission stream
or water effluent stream and possible interference from
other substances present should be considered in determining
this level.
QUESTION 2b: Self explanatory.
QUESTION 2c: This question concerns the extent to which
the amount of the new chemical substance discharged
to the environment is dependent on the operation of
air pollution control equipment or end-of-pipe treat-
ment systems for waste streams. This information will
be of value in determining the magnitude of potential
43
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release to the environment in the event such control or
treatment systems malfunction.
A description of air pollution control or water
treatment systems should include an explanation of the
type of system used (e.g., biological treatment, acti-
vated carbon absorption, steam stripping, scrubbing)
and the identification of the water effluent streams or
air pollution emission streams (noted on the schematic
flow diagram) that discharge into the control system.
In addition, operating parameters that are believed to
influence significantly the removal of the new chemical
substance must be identified and the control of these
parameters should be explained. If pretreatment of water
effluents from the manufacturing process is conducted
prior to treatment of combined effluent streams, the
efficiency of these systems must also be estimated.
This value may be reported as a range, if appropriate.
QUESTION 2d: This question concerns the basis for the
estimated environmental release rates and concentrations
in order to gain an understanding of their degree of
reliability. In this way the submitter may freely
provide his best estimates based on his capabilities and
available resources and be assured that EPA is aware
of their reliability. An explanation of the derivation
of the estimates in Table 2 should include (1) the
considerations taken into account (e.g., release data
44
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from similar manufacturing operations and process
operating conditions assumed, etc.), (2) the methodology
used (e.g., mass balance, emission factors, process
design data, etc.), and (3) the type of calculations
that were made.
QUESTION 2e; The submitter must report any degradation products
which he believes may be formed by release of the new
chemical substance to the environment and for which he
has knowledge of data that indicate such products may
adversely affect health or the environment.
QUESTION 3a; In describing the materials requiring disposal,
the submitter should report as specific compositional
information as possible. For example, in some cases
the submitter may be able to describe the composition
of the material by reporting the chemical identity and
the CAS Registry Number (if known) of the molecular
species of which it is comprised. Where the composition
of the material may vary significantly the submitter
should identify the approximate composition of the material
in ranges (percent by weight). If the exact composition
of the material is not known, the submitter should
characterize the material by describing the activity by
which it is generated, the precursors which led to its
formation and any compositional information. For example,
the submitter may report, "still bottoms consisting
primarily of diethylene triamine, triethylene tetramine
45
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and higher polyalkalene polyamines formed from the
distillation of 1,2 ethylene diamine manufactured from
1,2 ethylene dichloride and ammonia." The anticipated
method of disposal also should be described (e.g.,
sanitary or hazardous waste landfill, incineration,
or other physicochemical treatment processes). The amount
of the material to be disposed of must be reported in the
ranges listed below.
Code Amount
0 <10 Ibs/yr
1 10-100 Ibs/yr
2 100-1,000 Ibs/yr
3 1,000-10,000 Ibs/yr
4 10,000-100,000 Ibs/yr
5 100,000-1,000,000 Ibs/yr
6 1,000,000-10,000,000 Ibs/yr
7 >10,000,000 Ibs/yr
QUESTION 3b; The efficiency of the removal or destruction
process may generally be expressed as a percent. For
example, 99% of a substance may be removed or destroyed
through ion-exchange or incineration, respectively.
QUESTION 3c; Self explanatory.
QUESTION 3d: The number of workers exposed to the new
chemical substance would include workers at the site
of manufacture (if disposal took place on site) and
workers at any separate disposal site. The submitter
46
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should use the ranges provided on page 40 of this
appendix. The duration and frequency should be quanti-
fied as specifically as possible. For example, the
exposure may occur approximately 3 hours per day, 15
days per year. The magnitude should also be quantified,
if possible. In cases where this is not possible the
submitter should describe the circumstances which affect
the magnitude. For example: the place(s) that exposure
may occur (e.g., incinerator feed area), the proximity
of an individual to the substance and any particular
characteristics of the substance (e.g., high volatility)
should be discussed.
QUESTION 4a: Byproducts, co-products, feedstocks and
intermediates are defined in Section 720.2 of the Pre-
manufacture Notification Rules. The NIOSH Registry of
Toxic Effects of Chemical Substances published by the
Department of Health, Education and Welfare is a list
of substances and their potential toxic effects. Estimate
the maximum number of workers exposed during a one-year
period using the ranges provided on page 40 of this
appendix.
QUESTION 4b-. The submitter should provide the most
specific description of other substances that is
available. The submitter should identify the specific
chemical substances or classes of substance which may
be present. The information required (i.e., amount
47
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released and CAS Registry No., if appropriate) must
only be reported for substances if health or environmental
effects data have been submitted or if EPA has included
the substance on a list of substances which must be
reported.
The EPA list of chemical substances that must be
reported if released to the environment will be
available at the time of promulgation of the Premanu-
facture Notification Rules and Forms and will include the
following types of substances: chemicals regulated under
the Clean Air Act (CAA), the Clean Water Act (CWA), the
Resource Conservation and Recovery Act (RCRA), the Safe
Drinking Water Act (SDWA) and the Toxic Substances Control
Act (TSCA). These would include chemical substances that
are currently regulated such as vinyl chloride (CAA) and
PCB's (TSCA); chemical substances for which regulations are
being developed, such as the 129 toxic pollutants for which
discharge permits will be issued under the authority of the
FWPCA, hydrocarbon air pollutants being considered for
regulation under the CAA and chemical substances that
are under study or have been identified as potential
health or environmental problems.
48
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If the manufacture of the new chemical substance is expected
to result in the release of any of the listed substances,
the submitter must report the required environmental release
data insofar as they are known to or reasonably ascertain-
able to him. The amount of the substance released may
be reported using the ranges below.
Code
0
1
2
3
4
5
6
7
Amount
< 10 Ibs/yr
10-100 Ibs/yr
100-1,000 Ibs/yr
1,000-10,000 Ibs/yr
10,000-100,000 Ibs/yr
100,000-1,000,000 Ibs/yr
1,000,000-10,000,000 Ibs/yr
>10,000,000 Ibs/yr
QUESTION 4c:
QUESTION 4d:
QUESTION 5a:
QUESTION 5b:
GPD - gallons per day,
Self explanatory.
Self explanatory.
Self explanatory.
49
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QUESTION 5c: The objective of this question is to identify
potential hazards that may adversely affect the health
of persons involved in loading/unloading or transport
of the new chemical substance. Such hazards would
include exposure to the new chemical substance through
inhalation or dermal contact as well as explosion and
fire hazards. Where possible, quantitative or qualitative
estimates of the magnitude, duration, and frequency of
any expected human exposures should be reported.
QUESTION 5d; This question requires information related to
the magnitude of potential spills of the chemical sub-
stance during transportation, and the hazards to the
environment or human health that may result. The sub-
mitter must estimate the maximum amount of the new chemical
substance that may be shipped in a single transportation
unit. This amount can serve as an indicator of the magni-
tude of potential spills in the event of a transportation
accident. In providing this information the submitter
should consider transport of the new chemical substance as
well as mixtures produced by the submitter that contain
the new chemical substance.
QUESTION 5e: The objective of this question is to obtain
information concerning precautions or safeguards that
will be taken by the submitter to reduce (1) hazards
to operators involved in handling and transport, (2)
hazards to human health and the environment in the event
of a spill, and (3) the potential for accidental spills
during transport. Such safeguards may include special
50
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handling procedures, use of protective equipment, labels,
restriction on amounts to be transported in one unit,
special transport containers or packaging, special pro-
cedures for cleanup, or human and environmental protec-
tion if a spill occurs.
51
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Section C - Exposure From Processing Operations
Enter the name and street address of the processing
site. Do not enter the mailing address if it is different
from the street address. This information will permit EPA
to determine the population density surrounding the site
and through the use of climatological and topographical
factors, to determine the potential general population
exposure. The questions contained in this section are
intended to provide an estimate of the magnitude, dura-
tion and frequency of exposure to the chemical substance
that may occur during processing.
The word "processing" should be used in lieu of "manu-
facture" when referring back to previous explanations.
QUESTION la: See explanation of question la on page 36
of this appendix.
QUESTION Ib; See explanation of question Ib on page 38
of this appendix.
QUESTION lc: See explanation of question Ic on page 39
of this appendix.
QUESTION Id; See explanation of question Id on page 39
of this appendix.
QUESTION le; See explanation of question le on page 49
of this appendix.
QUESTION If; "Function" and "application" are defined on
pages 15&16 of this appendix.
52
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QUESTION Ig; Products should be described by function and
application which are defined on pages 15&16 of this
appendix.
QUESTION 2a: See explanation of question 2a on page 40
of this appendix.
QUESTION 2b: See explanation of question 2b on page 43
of this appendix.
QUESTION 2c: See explanation of question 2c on page 43
of this appendix.
QUESTION 2d: See explanation of question 2d on page 44
of this appendix.
QUESTION 3a: Reporting of materials which require disposal
should be limited to those which contain the new chemical
substance. For further information, see the explanation
of question 3a on page 45 of this appendix.
QUESTION 3b: See explanation of question 3b on page 46
of this appendix.
QUESTION 3c: Self explanatory.
QUESTION 3d: See explanation of question 3d on page 46
of this appendix.
53
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Section D - Exposure From Consumer Use
QUESTION 1; "Function" and "application" are defined on page
15 of this appendix. Consumer products include both
products that are purchased by the general population
and products that the general population may come in
contact with (e.g., materials used in roadway surfacing).
The "total amount devoted to each product" may be report-
ed in ranges and should be the manufacturer's best esti-
mate of the total amount of the reported production volume
that may be used in a given product.
If the product will be marketed for use by the
general population, estimate the number of persons
that may use the product. If the product may not be
purchased by the general population, but may result in
their being exposed to the substance (e.g., substance
is used in public transport seat covers), estimate the
number of persons that may experience these exposures.
Consumer market population ranges are provided for the
submitter. As specified below, enter the digit which
corresponds to the appropriate consumer market range.
Code Consumer Market Population
Number of Persons
0 <10,000
1 10,000-100,000
2 100,000-1,000,000
3 1,000,000-10,000,000
4 10,000,000-100,000,000
5 >100,000,000
54
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The frequency and duration of exposure should
be quantified as specifically as possible. For example,
a spray paint product might be used approximately 3
times per year for a period of 1 hour per use.
Consumer products may be constructed or formu-
lated in a manner so as to reduce or prevent human
exposure. For example, the substance may be encapsu-
lated and thus released only upon disposal or a pro-
duct may be formulated as a mixture which contains a
limited amount of the new chemical substance. The sub-
mitter should check if any products which contain the
new chemical substance are so constructed or formulated.
QUESTION 2: Provide a quantitative estimate of the level of
exposure, if possible. If quantitative estimates of the
level of exposure are not possible, the submitter must
describe the normal conditions of use including the
expected location(s) of use, the proximity of the user
to the substance upon use, and any special characteristics
of the product (e.g., physical state of the substance).
QUESTION 3; The objective of this question is to determine
the submitter's basis for arriving at the exposure esti-
mates he has reported in questions 1 and 2 and thus pro-
vide an understanding of their degree of reliability.
The submitter must discuss the factors considered (e.g.,
release data from similar products on the market), the
methodology used and, where appropriate, explain the
55
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actual modeling and calculations that were performed.
Uncertainties in these estimates should also be discussed,
QUESTION 4; Construction and formulation are described in
question 1.
QUESTION 5: Self explanatory.
56
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Part III - Risk Analysis and Optional Data
(This part of the form is optional)
Section A - Risk Analysis
QUESTION 1: The objective of this question is to determine
the underlying considerations of the manufacturer in
developing a testing and evaluation scheme and the
scientific rationale(s) of the approaches that he imple-
mented. For example, if a chemical substance is in a
class of substances which are believed to be persistent
in the environment, the manufacturer may have given
special consideration to this factor in determining the
scope of his testing requirements.
QUESTION 2; This question is designed to elicit the
manufacturer's reasons (if any) for not developing
additional data. Several factors may mitigate the need
for data concerning particular properties, character-
istics or effects. For example, if a substance is highly
reactive and is destroyed or altered at the manufacturing
site using conventional water treatment procedures,
environmental transport and transformation studies might
not be necessary. The manufacturer should bring such
considerations to EPA's attention. In addition, the
submitter should discuss why he feels it unnecessary to
evaluate a particular health and environmental effect
of the new chemical substance. This too should include
a discussion of factors which mitigate the risks presented
by the chemical substance.
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QUESTION 3; The objective of this question is to determine
what factors would mitigate the potential risk(s)
suggested by test results or other information reported
on the chemical substance. For example, industrial
hygiene procedures, engineered safeguards and explicit
instructions given to processors may mitigate the
potential risk to workers suggested by toxicity studies.
QUESTION 4; Self explanatory.
QUESTION 5: The objective of this question is to identify
the potential conditions of maximum exposure to the new
substance through use and abuse, and the exposures that
might occur in the future. The manufacturer should
discuss the risks presented by the substance under these
conditions and identify the most susceptible populations.
For example, the manufacturer may describe the potential
exposures to a chemical substance used in an aerosol
product in a poorly ventilated room. In addition, he
may discuss the risk to asthmatics (or other susceptible
populations) under such conditions.
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Section B - Structure/Activity Relationships
QUESTION 1; When explaining the similarity of related
chemicals, a concise statement of facts is necessary.
Only chemical similarities should be discussed here,
not biological activity. For example, if a "new chemical"
nonionic surfactant butanoldiethanolamine were compared
with triethanolamine, one would probably compare functional
groups, octanol water partition coefficient, and vapor
pressure at normal temperatures of use. Depending on
the extent of structure/activity analysis performed on
the new chemical, much more data may be presented (e.g.,
chemical reactivity data). In all cases, submit litera-
ture citations or test data to substantiate any data
presented.
QUESTION 2; The response to this question should discuss
the scientific basis upon which you concluded that the
structural similarities discussed in question 1 above
provide a valid basis for evaluating relevant properties
of the new chemical substance.
Structural similarity alone may not present a valid
basis for comparison. For example, given a complex
aromatic compound, one might compare an existing chemical
with a hydroxyl group on an aromatic ring with a new
chemical which is identical in all respects except one -
a chlorine atom has been substituted for the hydroxyl
group. Such substitution may produce drastic changes in
the biological activity of the compound. It is important
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therefore that the submitter justify his conclusion
that such a valid basis for comparison exists. Submit
supporting data or literature citations where appropriate.
QUESTION 3: Explain how such similarities in structure and
reactivity can be extrapolated to "real world" systems.
For example, explain how increasing a side chain length
from eight carbons to nine carbons is not likely to produce
a major change in the fat solubility of a new chemical
or in its ability to pass through cell membranes. As
another example, give reasons for asserting that adding an
electron-withdrawing group to an ester will likely make
the ester less persistent in the aquatic environment
(more labile to hydrolysis). Extrapolation from apparent
chemical similarities on paper to "real world" systems
should be submitted to substantiate any claims made
whenever possible.
QUESTION 4; This discussion is warranted when data have
not been presented on compounds that, in an initial
assessment, appear very similar to the new chemical.
Some valid reasons for not submitting data regarding
related compounds could be (1) one or more key pro-
perties or structural features invalidate the comparison;
(2) the exposure route is irrelevant (dermal sensitiza-
tion data exist, but there will be no dermal exposure
to the new chemical); and (3) the data are not reasonably
ascertainable.
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Section C - Industrial Hygiene
QUESTION 1: This question attempts to establish the amount
of personnel resources devoted to your industrial hygiene
program. The value of any industrial hygiene program
may depend to a large degree on the experience and
competence of the individual(s) responsible for its imple-
mentation and the amount of time spent in this capacity.
Employee training is a key element in any industrial
hygiene program. When workers understand the hazards,
they are better prepared to deal with them in the event
of an emergency. Further, their familarity with the use
and purpose of personal protective equipment leads to
their greater acceptance of this part of the program.
A respiratory protection program should include
the following major elements: (1) An employee training
program on the purpose of respirators, and proper use,
maintenance and storage of them; (2) the selection of
appropriate respirators for the particular substance
of concern, e.g., organic vapor canister for volatile
organics; and (3) initial and periodic fit-testing to
assure that each employee is equipped with a respirator
which will afford him maximum protection.
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QUESTION 2; An action level is considered to be some
fraction (usually one-half) of the maximum permissible
limit which has been designated for the subject chemical
in the workplace. This maximum limit is usually based
on an examination of the possible health effects and
control technology. As the name implies, when an action
level is reached or exceeded, certain precautionary
measures are implemented.
QUESTION 3; Aside from the obvious benefit of affording
emergency medical treatment to employees, a medical
surveillance program may enable detection of early signs
or symptoms of overexposure to toxic chemicals, thus
triggering precautionary control measures and medical
treatment if necessary. Pre-employment medical
examinations (including medical histories) can be used
to screen individuals who are at higher risk (predisposed)
to the potential health hazards from exposure to the
subject chemical. Further, inclusion of biological
monitoring, e.g., urine sampling and blood tests, in
the program may be effective in detecting overexposures.
The use of medical examinations for such purposes depends
on the properties and biological effects associated with
each subject chemical. This question attempts to get at
the applicability of medical examinations to the
submitter's situation.
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Section D - Engineered Safeguards
QUESTION la (i) : Design features which would act as safe-
guards would include automatic controls, enclosed
systems, special construction materials, etc. Maintenance
procedure safeguards would include automated washout
of tanks or lines prior to repair.
Question la(ii): Self explanatory.
QUESTION la(iii) : Self explanatory.
QUESTION la(iv): Other safeguards would include extensive
training programs for operators, regular safety audits,
etc .
QUESTION Ib: Using the process flow diagram required in
Section E of Part I, graphically illustrated the location
of safeguards used to limit worker exposure. For example,
show the location of local ventilation systems in
relation to the types of equipment used in the manufac-
turing or processing operation.
QUESTION Ic : For example, the function of the vacuum system
would be to reduce dust at a drumming station.
i^: An example response would be "Vacuum system
has rated efficiency of 99.9%." The relative contribu-
tion would be "The drumming station cannot be operated
safely if vacuum pump fails."
QUESTION le: For example: "Air compressor failure would
result in loss of air pad on storage tank."
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QUESTION If: Using the le example, the response would
be "Frequency is estimated at once/year with a resulting
gas release of 50 Ibs. Workers are equipped with
safety apparatus to prevent exposure."
QUESTION_JLg_: Using the le example, the response would
be "The release is controlled by starting an
auxilliary portable air compressor. The portion of the
chemical that is released dissipates in the air."
QUESTION 2a(i): Self explanatory.
QUESTION 2a(ii): Safeguards would include filters, scrubbers,
electrostatic precipitators, carbon beds, etc.
QUESTION 2a(iii): Design features would include vacuum
systems to evacuate lines for maintenance, spill collec-
tion pads for tanks, etc.
QUESTION 2a(iv): An example of an operating procedure would
be recycling effluent that is highly contaminated with
a toxic substance.
QUESTION 2a(v): Emergency control equipment would include
drainage ditch valves, surge basins, etc.
QUESTION 2a(vi): Self explanatory.
QUESTION 2b: See le.
QUESTION 2c: See Id.
QUESTION 2d; Redundant controls and emergency procedures
would include shut-off valves for effluent lines, surge
tanks where effluent flow could be diverted, secondary
treatment systems, etc.
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QUESTION 2e: See 2d for redundant controls and emergency
procedures.
QUESTION 2f: Disposal would include landfills, incineration,
deep-well injection, treatment systems, etc.
QUESTION 2g; Self explanatory.
QUESTION 2h: Self explanatory.
QUESTION 3: This question concerns action levels for plant
releases to the environment. Action levels are defined
in question 2 on page of this appendix.
Section E - Industrial Process and Use Restriction Data
Self Explanatory.
Section F - Process Chemistry
Self Explanatory.
Section G - Risk Factors: Economic and
Non-Economic Benefits
QUESTION 1: Economic changes resulting from availability/
production of the new chemical.
QUESTION la: The response to question la should be an
estimate, based on current information, of the total
Jive-year gross market (sales) value of the chemical.
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If the product life is expected to be less than five
years, the submitter should estimate the total gross
sales value of the chemical over its entire life.
The estimate provided in la should include
the five-year projected gross value of any co-products
resulting from production of the new chemical.
QUESTION Ib; As a first step, the submitter should attempt
to identify those products (feedstocks, raw materials,
intermediates, endproducts, or non-chemical products)
which will potentially be affected by the entry of the
new chemical. These would include products (1) which
are associated in production with the new chemical
(e.g., an intermediate used in production or an end-
product which will contain the new chemical); (2) which
are substitutes or complements for the new chemical or
any of its co-products; or (3) which are substitutes
for any endproducts containing the new chemical (e.g.,
an intermediate which will be replaced by the new
chemical intermediate or a non-chemical product in
another industry such as a steel or wood product which
will compete with an endproduct containing the new
chemical).
As a second step, the submitter should attempt
to estimate the price effects on any affected products
resulting from changes in demand/supply created by
availability of the new chemical. If the submitter has
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reason to believe that a particular price effect (either
an increase or decrease) will result but he cannot esti-
mate the extent of it, he should identify the affected
product and write "uncertain" in the column labelled
"Price Change." Also indicate the current price of the
affected product as accurately as possible.
QUESTION lc; The procedure for answering question Ic is
analogous to that for answering question Ib. Instead
of estimating price changes, however, the submitter
should now estimate production changes in products
affected by entry of the new chemical.
QUESTION Id; The response to this question should be an
estimate of the employment changes which may occur
over the first five years of production that are
caused by availability of the new chemical. There are
generally two causes for employment changes: (1) pro-
duction of the new chemical itself, and (2) production
of any existing feedstocks, raw materials, intermediates,
end products or non-chemical productions which are
affected by entry of the new chemical because (1) they
are associated with the production of the new chemical,
(2) they are substitutes or complements for the new
chemical or any of its marketable byproducts, or (3)
they are substitutes for any end products containing the
new chemical. For example, if the new chemical will
result in a price decrease of end product X, increased
production of the end product may necessitate additional
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employment; decreased production of end product Y, which
is a substitute for the now less costly end product X,
may necessitate employment reductions.
In most respects the procedures for esti-
mating employment changes resulting from the second
cause cited above should be analogous to those used
to answer questions Ib and Ic.
If the submitter has reason to believe that
a particular employment effect will occur but he cannot
estimate the extent of it, he should indicate the cause
and write "uncertain" in the column labelled "Employ-
ment Change."
QUESTION le The response to question le requires an
explanation of how employment changes in a region or
community resulting from production of the new chemical
represent an extraordinary benefit to the region or
community. In particular, if production of the new
chemical will result in a significant decrease in the
rate of regional or community unemployment, that should
be brought to EPA's attention.
QUESTION If: The response to question If requires an
estimate of the changes in exports and imports resulting
from production of the new chemical. There are two
general causes of import or export changes: (1) pro-
duction of the new chemical itself (and any marketable
byproducts), and (2) production of any raw materials,
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feedstocks, intermediates, end products, or non-chemical
products which are affected by entry of the new chemical,
Products could be affected by entry of the new chemical
either because they are associated with the production
of the new chemical or because they are substitutes or
complements for the new chemical, any of its marketable
byproducts, or any end products containing the new
chemical.
In most respects, the procedure for answering
question If will be analogous to that used to answer
questions Ib, Ic, and Id.
If the submitter has reason to believe that
a particular change in exports or imports will occur,
but is uncertain of the extent of the effect, identify
the cause and write "undertain" in the column labelled
"Change in Exports" or "Change in Imports."
QUESTION Ig: The response to question Ig should be an
estimate of the gross dollar amount of investment in
facilities and equipment associated with production of
the new chemical, the timing (year) of outlays, and the
production capacity created.
QUESTION lh: The response to this question should be a
listing of the unique properties of the chemical
that give rise to a demand for it (i.e., give it value).
These properties could include (but are not limited to)
the chemical's capacity to increase productivity, any
convenience factors associated with the chemical (such
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as time or labor saving features), cost saving features,
or any aesthetic factors associated with the chemical
(for example, its capacity to produce desirable texture,
finish, or color characteristics). The submitter should
compare the properties of the new chemical with those
of each existing substitute listed in question li,
pointing out ways in which the new chemical represents
an improvement over each substitute.
QUESTION li: The submitter should identify any existing
chemical products which fulfill the same purposes as those
listed in Ih.
If there are not existing substitutes for a
particular use, the submitter should so indicate.
QUESTION 2a: The response to 2a should be a listing of
the specific aspects or uses of the chemical which
contribute directly or indirectly to human health or
safety. There are generally two cases in which a
human health or safety benefit may be involved: (1) a
case in which the new chemical will replace a more
risky (i.e. toxic) one; and (2) a case in which the
chemical is used in a health or safety benefiting
manner, such as in fire retardants, food preservatives
or medicines.
'QUESTION 2b: The response to question 2b should be analogous
to the response to question li, the difference beina that
2b refers to the uses listed in Question 2a.
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QUESTION 2c: The response to question 2c requires a
listing of any environmental benefits, energy or
natural conservation factors resulting from avail-
ability of the new chemical. Wastewater treatment
chemicals, forest fire control chemicals, chemicals
present in insulation products, and chemicals which
entail reduced processing water requirements are all
examples of chemicals which represent environmental,
energy, or natural resource benefits.
QUESTION 2d: The response to question 2d should be analogous
to the response to li and 2b, the difference being that
2d refers to the uses listed in question 2c.
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