CHEMICAL PROCESSING UNDER TSCA
(August 26, 1992)
Background Information Document
Office of Pollution Prevention and Toxics
Office of Prevention, Pesticides and Toxic Substances
U.S. Environmental Protection Agency
Washington, D.C. 20460
NOTE: In creating this compilation, EPA has attempted to
locate and include all relevant documents prepared by the
Agency since January 1, 1977, the effective date of TSCA.
EPA acknowledges the possibility that there may be some
relevant materials inadvertently overlooked by EPA staff
and welcomes the submission of such missing documents.
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DEFINITIONS
OF
CHEMICAL "PROCESS," "PROCESSOR" MUD "PROCESSING"
UNDER TSCA AND TSCA REGULATIONS
BACKGROUND DOCUMENT (1/77 THROUGH 10/90)
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INDEX
TSCA Legislative History 3
§2 Statutory Findings, Policy and Intent 9
§3 Definitions 10
§4 Testing 12
§5 PMNs 19
SNURs .,, 29
§6 Regulation 31
PCBs 33
CFCS ^ . . . 41
Asbestos 43
§7 Imminent Hazard 48
§8 Recordkeeping and Reporting 49
§8(a) Chemical Specific 51
§8 (a) CAIR 55
§8 (a) Inventory 91
§8 (a) PAIR ., 95
§8 (a) Asbestos 154
§8 (b) Inventory 159
§8 (c) Allegations 160
§8 (d) Health & Safety Studies 170
§8(d) Asbestos 176
§8 (e) Substantial Risk 182
§8(f) Definitions 183
8/92 Supplement to 10/90 Background Document 184
Contents 185
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THE LEGISTLATIVE HISTORY OF TSCA
The Legislative History of TSCA contains practically no
discussion of what constitutes "processing" under section 3 of
TSCA. In an effort to be inclusive, the following are a few
passages that vaguely relate to the definition, but none of them
are more clear than the statutory definition itself. They are not
presented in any particular order.
The Conference Report discussion of TSCA section 8 states:
"... The conference substitute provides an illustrative
list of the kinds of activities for which recordkeeping
and reporting may be required. The list includes such
information as the identity of the chemical, categories
of use, amounts manufactured or processed, by products,
existing data, employees exposed, and the manner or
method of disposal. The information specified may be
required by the Administrator 'insofar as known to the
person making the report or insofar as reasonably
ascertainable'. The conferees intend that 'reasonably
ascertainable1 standard be an objective, rather than a
subjective one. Thus, the manufacturer or processor must
provide information of which a reasonable person similar-
ly situated might be expected to have knowledge. The
conference substitute retains the exemptions in the House
amendment relating to reporting by small businesses. The
intent of the conferees is to protect small manufacturers
and processors from unreasonably burdensome reporting
requirements. However, the conferees do not intend to
deny the Administrator access to information which may be
necessary either to enforce a final rule or order.
Therefore, the conferees have specifically authorized the
Administrator to obtain reports from small manufacturers
and processors of a chemical substance or mixture with
respect to which a rule has been proposed or promulgated
under section 4, 5(b)(4), or 6, or with respect to which
an order or rule is in effect under section 5(e) or 5(f) .
Thus, once a rule has been proposed, the Administrator
may, by rule, issued in accordance with the informal
rulemaking procedures of section 553 of Title 5, United
States Code, require reporting from small manufacturers
and processors . . . ."
[H.R. Rep. No. 1679, 94th Cong., 2d Sess. (1976), at 80, reprinted
in. Environmental and Natural Resources Policy Division of the
Library of Congress, 94th Cong. 2d Sess., A Legislative History of
the Toxic Substances Control Act. (Com. Print 1976) ("Leg. Hist.")
at 693.]
As part of the Senate Consideration of the Conference Report,
Senator Magnuson stated:
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"A vital provision of the conference substitute is
section 8, which describes the authority of the [EPA]
Administrator to require recordkeeping and reports from
manufacturers and processors, and in some cases other
persons, with respect to information concerning chemical
substances. The authority will be vital in determining
what substances are being produced, what they are being
produced for, and other information. The general
reporting requirements generally reach manufacturers or
processors of chemical substances. ..."
"Leg. Hist." at 726.
The Senate Report on the Senate version of TSCA states:
"There are mixtures such as adhesives, paints and inks,
which can produce chemical substances upon end use.
Chemical substances produced upon end use of such mix-
tures should not be considered new chemical substances
automatically subject to the premarket notification
provisions of this section. Manufacture is defined under
section 3(a)(7) to mean to 'import, produce, or manufac-
ture for commercial purposes.' These types of substances
would not be covered under the premarket notification
provisions because they are not manufactured for com-
mercial purpose, per se. Similarly, minor reactions
occurring incidental to the mixing process or upon
storage of such a mixture, such as the cross-linking of
polymers, would not constitute a basis for subjecting
such mixtures to the premarket notification provisions
intended for new chemical substances because the
resulting substances are not manufactured for commercial
purpose.
"Such chemical substances arising during the formulation,
storage or use of such mixture should be considered as
byproducts of the precursor substance or substances. The
responsibility for reporting and testing such byproducts
under the provisions of this legislation would then fall
upon the manufacturer of the precursor substance. Of
course, the Administrator may specifically subject any
mixture to the premarket notification provisions."
H.R. Rep. No. 689, 94th Cong. 2d Sess., (1976) at 19, reprinted in.
Legis. Hist, at 175.
Regarding TSCA section 8:
"This subsection also contains an illustrative list of
the kind of information which the Administrator may
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require of manufacturers or processors of chemical
substances. Included are the identity of substances,
categories or proposed categories of use, estimates of
the amount to be produced, and estimates of the amount
which will be produced for each of its categories or
proposals of use, a description of byproducts, all
existing data concerning the environmental and health
effects of the substance or mixture, and estimates of the
number of workers who will be exposed to the chemical
substance."
H.R. Rep. No. 689, 94th Cong. 2d Sess., (1976) at 22, reprinted inf
Leqis. Hist, at 178.
Additional Views of Mr. Baker:
. . . "This bill permits regulation of toxic chemicals-at
points in the chain of manufacture and use that are
impossible to reach under existing laws."
H.R. Rep. No. 689, 94th Cong. 2d Sess., (1976) at 89, reprinted in.
Leais. Hist, at 205.
Senate Consideration of Senate Bill: .
Mr. Tunney: "S. 3149 will close major gaps in the law
that leave the public inadequately protected against the
unregulated introduction of hazardous chemicals into the
environment. S. 3149 will assure that chemicals will
receive careful premarket scrutiny before they are
manufactured or distributed to the public."
H.R. Rep. No. 689, 94th Cong. 2d Sess., (1976) at 91, reprinted in.
Legis. Hist, at 207.
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"... [The] Passage of S. 3149 would provide a means by
which the public interest would be protected by assuring
that safe and beneficial chemicals continue to be intro-
duced into the marketplace while insuring that these
chemical substances that have unacceptable health and
environmental costs associated with them are properly
restricted. Existing Federal legislation simply does not
provide the means by which adverse effects on human
health and the environment can be ascertained and
appropriate action taken before chemical substances are
first manufactured and introduced into the marketplace."
H.R. Rep. No. 689, 94th Cong. 2d Sess., (1976) at 99, reprinted in.
Legis. Hist, at 215.
The House Committee Report states in its discussion about the basis
for the legislation,
. . ."Further, tris 2,3-dibromopropyl phosphate, a fire
retardant widely used in such items as children's
pajamas, has been shown to have mutagenic effects in
microbial systems. And there are, unfortunately,
numerous other examples of harm resulting from the
industrial uses of chemicals. . ."
H.R. Rep. No. 1341, 94th Cong., 2d Sess. (1976), at 5, reprinted
in. Environmental and Natural Resources Policy Division of the
Library of Congress, 94th Cong. 2d Sess., A Legislative History of
the Toxic Substances Control Act. (Com. Print 1976) ("Leg. Hist.")
at 413.
The House Committee Report says:
"Although the term chemical substance excludes mixtures
of chemical substances, mixtures are not excluded from
regulation under the bill. However, mixtures are regu-
lated in a different manner than chemical substances -
they are not subject to the manufacturing and processing
notices for new chemical substances under section 5 and
special findings are required before testing of them may
be required or before the can be subject to rules under
section 8 (a) requiring recordkeeping and reporting for
them."
H.R. Rep. No. 1341, 94th Cong., 2d Sess. (1976), at 12, reprinted
in. "Leg. Hist.") at 420.
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There is also some discussion of "end user" v. "manufacturer" in
the House Report:
"For example, there are certain substances or mixtures,
such as adhesives, paints, inks, and drying oils, which
during storage or upon end use, when exposed to environ-
mental factors such as air, moisture, or sunlight,
undergo a chemical reaction which produces a different
substance or mixture. . . .In such cases, the chemical
reaction is merely incidental to the end use or storage
of the original substance or mixture. The substance or
mixture produced is not used as a chemical substance or
mixture, per se. It is not the Committee's intent that
a person, such as a painter, who is engaged in the end
use or storage activity in which such a chemical reaction
occurs is to be considered a manufacturer because of the
reaction. Thus, such a person would not be subject to
the notification requirements of section 5 even though a
chemical substances resulting from the reaction is not
included in the inventory under section 8(b)."
H.R. Rep. No. 1341, 94th Cong., 2d Sess. (1976), at 13, reprinted
in, "Leg. Hist.") at 421.
The House Committee Report states that:
"Subsection (j) provides that for purposes of section 5,
the terms "manufacture" and "process" means to manu-
facture or process for commercial purposes. Since the
term "manufacture" is defined to include "import",
persons who intend to import substances for commercial
purposes will be treated the same as a domestic
manufacturer under section 5.
"By the use of the term "for commercial purposes" the
Committee does not intend to restrict coverage to
substances manufactured or processed "for sale". Any
commercial purpose, such as use as a chemical inter-
mediate in a manufacturing process, is sufficient to
bring the manufacturing or processing of a substance
within the ambit of section 5. The committee realizes
that there are certain minor reactions occurring
incidental to the mixing process or upon storage of a
mixture, such as the cross-linking of polymers. Such a
minor reaction may result in what would technically be
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considered a "new" chemical substance. However, since
the "new" substance is not manufactured for commercial
purposes per se it would not be subject to the notifi-
cation provisions of the section."
H.R. Rep. No. 1341, 94th Cong., 2d Sess. (1976), at 30-31,
reprinted in. Environmental and Natural Resources Policy Division
of the Library of Congress, 94th Cong. 2d Sess., A Legislative
History of the Toxic Substances Control Act. (Com. Print 1976)
("Leg. Hist.'M at 437-438.
U.S. SUPREME COURT RULING
In Chevron U.S.A. Inc. v. Natural Resources Defense Council.
the Supreme Court stated that in reviewing an agency's
interpretation of a statute, the court's first task is to determine
"whether Congress has directly spoken to the precise question at
issue. Chevron U.S.A. Inc. v. Natural Resources Defense Council.
467 U.S. 837, 842 (1984). If it has, the agency must give effect
to Congress1 intent. Chevron at 842-43. If it has not, the Court
must defer to the agency interpretation if that interpretation is
a reasonable accommodation of conflicting policies that were
committed to the agency's care by the statute.'" Chevron at 845
(citation omitted).
Therefore, as the language of TSCA is very broad, EPA has the
ability to interpret the definition broadly. If there are policy
reasons to interpret the definition more narrowly, including but
not limited to the need to recognize the cost of regulation on
small business, EPA may as a matter of policy, rather than as a
legal interpretation of the statutory definition, choose not to
apply the definition to certain processors. To do so, however, may
result in inconsistency among programs.
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S2 ("FINDINGS. POLICY. AND INTENT.")
TSCA (THE ACT)
TSCA §2(a)(2) states that the U.S. Congress found that "among
the many chemical substances and mixtures which are constantly
being developed and produced, there are some whose manufacture,
processing, distribution in commerce, use, or disposal may present
an unreasonable risk of injury to health or the environment. . ."
Further, §2(b)(l) of TSCA states that it is the policy of the
United States that "adequate data should be developed with respect
to the effect of chemical substances and mixtures on health and the
environment and that the development of such data should be the
responsibility of those who manufacture and those who process such
chemical substances and mixtures."
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S3 ("DEFINITIONS.")
T8CA (THE ACT)
According to §3(10) of TSCA, "The term 'process' means the
preparation of a chemical substance or mixture, after its manu-
facture, for distribution in commerce-
" (A) in the same form or physical state as, or in a
different form or physical state from, that in
which it was received by the person so pre-
paring such substance or mixture, or
"(B) as part of an article containing the chemical
substance of mixture."
According to §3(11) of TSCA, "The term 'processor' means any
person who processes a chemical substance or mixture."
According to §3(4) of TSCA, "The term 'distribute in commerce1
and 'distribution in commerce1 when used to describe an action
taken with respect to a chemical substance or mixture or article
containing a [chemical] substance or mixture, mean to sell, or the
sale of, the substance, mixture, or article in commerce; to intro-
duce or deliver for introduction into commerce, or the introduction
or delivery for introduction into commerce of, the substance, mix-
ture, or article; or to hold, or the holding of, the substance,
mixture, or article after its introduction into commerce."
It is important to note that §3 of TSCA does not define the
term "article."
QUESTION AND ANSWER DOCUMENTS
A July 25, 1986 "Question and Answer Summary" prepared by EPA
following a June 10, 1986 Agency-sponsored seminar on the industry
obligations under TSCA presents the following with regard to the
term processor:
"Question: How are 'processors' of chemical substances
defined? When does a person become a processor and thus
subject to reporting and recordkeeping requirements? What
about a situation where a person controls all distribu-
tion of a substance manufactured by another firm?
"Answer: Under TSCA, a processor prepared a chemical
substance or mixture, after the substance has been
manufactured or imported, for distribution in commerce in
one of three forms: (1) In the same form or physical
state as that in which the substance or mixture was
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received by the processing firm, (2) In a different form
or physical state from that in which the substance or
mixture was received by the processing firm, or (3) As
part of an article containing the chemical substance or
mixture. A person becomes a processor of a chemical
substance or mixture by undertaking that 'preparation1
step. The definition of processing includes repackaging
for commercial distribution, the manufacture of mixtures,
and the production of articles.
"If a person controls all distribution of a substance
manufactured by another firm, and that company does not
prepare, repackage, or otherwise process the substance
prior to distribution, the firm is a distributor but not
a processor of the substance. If,any such preparation
does occur, the firm is considered by EPA to be [both] a
processor and a distributor.
"Persons should refer to TSCA section 3 and the general
definition sections of specific regulatory requirements
for definitions of key regulatory terms. The following
sections in Title 40 of the Code of Federal Regulations
(CFR) contain definitions for some of EPA's regulatory
actions with regard to existing chemical substances: §§
704.3 and 712.3 (section 8 (a) reporting and recordkeeping
rules); § 716.3 (section 8(d) health and safety data
rules); §§ 721.3 and (by reference) 720.3 (section
5(a)(2) significant new use rules (SNURS)); § 717.3
(section 8(c) recordkeeping requirements); and § 707.63
(export notification requirements)."
The OTS Existing Chemicals Program (ECP) "QUESTION AND ANSWER
SUMMARY" prepared following the May 5, 1987 Agency-sponsored TSCA
seminar on industry obligations under TSCA presents the following
information regarding process:
"Q.29. Summarize small business exemptions under TSCA.
"A.29 The Agency has defined 'small processor'
on a rule-by-rule basis and intends to continue to do so
for the foreseeable future "
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S4 ("TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.")
T8CA (THE ACT)
According to §4(b) (3) (B) of TSCA, "The following persons shall
be required to conduct tests and submit data on a chemical sub-
stance or mixture subject to . . . [a §4 test rule]: ...
11 (ii) Each person who processes or intends to process
such chemical substance or mixture if the Administrator
makes a [proscribed] finding . . . with respect to the
processing of such substance or mixture.
"(iii) Each person who . . . processes or intends . . .
to process such substance or mixture if the Administrator
makes a [proscribed] finding . . . with respect to the
distribution in commerce, use, or disposal of such
chemical substance or mixture."
PROPOSED S4 TEST RULES
Part III E. ("Responsibility for Testing") of a July 18, 1980
proposed TSCA §4 test rule (45 FR 48524-48566) on chloromethane and
chlorinated benzenes gives the following information on pages 48534
and 48535 about chemical processing and processors:
"In most cases, EPA expects that other activities besides
manufacturing may present exposure opportunities and,
therefore, an exposure risk, so that processors will
usually be required to test along with manufacturers.
This may present practical problems, however, because the
statutory definition of processing is quite broad . . .
. [(the full TSCA §3 definitions of both processor and
process is quoted in the FR at this point)]. It should
be noted that the term 'processor1 under TSCA has a much
broader meaning than the common or industry's meaning.
The following examples illustrate activities that would
cause a person to be considered a processor under TSCA.
"Example 1. A person reacts chemicals X and Y to produce
a new chemical substance, Z. This person is a processor
of X and Y and a manufacturer of Z. This example is the
closest to industry's meaning of the term.
"Example 2. A person who purchases or manufactures
chemicals and then mixes or reacts them is a processor of
each chemical if the mixtures or compounds are dis-
tributed in commerce. Processors that fall within this
example include producers of paints, automotive products
(e.g., antifreeze, oil additives, etc.) and specialty
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cleaners and floor wax preparations. This example covers
a large segment of the processor class.
"Example 3. A person who heats and mixes powdered
resins, fillers, pigments, and plasticizers to form a
homogeneous mix which is then formed into sheets of a
desired thickness would be a processor of each component
because the components are distributed in commerce as
part of an article. Tire manufacturers and producers of
rubber and plastic articles would fall within this
example. [The] processors [cited] in this example are
similar to those in example 2. except that the products
that are distributed in commerce are articles rather than
chemicals.
"Example 4. A person who purchases steel cans and then
coats the cans with a resin would be a processor of the
resin, since the resin is now a part of an article which
is distributed in commerce. Similarly, a person who
purchases printing ink and then applies the ink to paper
or boxes would be a processor of the ink which has become
a part of an article. Also tanneries and textile mills
would be processors of the dyes used to color the leather
and fabric. Persons in these examples add chemicals to
previously produced articles.
The above examples are not meant to be inclusive. They
are only provided to illustrate the breadth of the TSCA
definition of processor and assist persons in determining
whether their activities fall within the TSCA meaning of
•process.' The 1977 Census of Manufacturers indicates
that there are approximately 11,000 establishments in the
Standard Industrial Classification (SIC) 28, Chemicals
and Allied Products. Examples 1 and 2 would fall within
SIC 28. Processors in example 3 are in SIC 30, Rubber
and Miscellaneous Plastic Products, and number approxi-
mately 12,000 establishments. The types of processors
[cited] in example 4 are in SIC 27, Printing and
Publishing; SIC 226, Textile Finishing; and SIC 3479,
Metal Coating and Allied Services, and account for
approximately. 45,000 establishments.
"The Agency is concerned that, if all processors covered
by the Act were subject to a [§4] test rule, there would
be difficulties experienced by EPA and the industry in
administering the exemption and reimbursement provisions
of TSCA Section 4. Consequently, EPA has examined various
alternatives for exempting certain kinds of processors
from all [§4] test rules or specific ones. Examples of
them are (1) excluding some processors from coverage on
the basis that their principle activity is not of a
nature that has traditionally been considered processing
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within the chemical industry, (2) restricting coverage of
the [§4] rule to members of the chemical industry, e.g.,
SIC 28, (3) excluding processors who incorporate the
substances or mixtures into an article in commerce, (4)
excluding all processors downstream of the point at which
the subject chemical is reacted or formulated into a
substance or mixture with a new identity, and (5)
excluding those processors who are small businesses.
"Each of these [alternatives] has substantial advantages
and disadvantages, and EPA does not attempt to resolve
them in this proposal. At a public meeting [held] on
September 25, 1979, and in subsequent conversations,
members of the chemical industry expressed an interest in
deciding how to allocate costs and testing responsi-
bilities most fairly. Although the comments recently
submitted by the Chemical Manufacturers Association on
the advance notice of proposed rulemaking [(44 FR 54284;
September 19, 1979)] on data reimbursement deal with this
question, they do not offer a solution to the problem of
who is subject to the [TSCA §4] rule. EPA is requesting
comments on the approach it should take under §4 with
respect to processors, including comments on the five
alternatives listed above and any other approaches which
would limit the applicability of §4 test rules, yet be
equitable and provide flexibility."
Part III C. ("Persons Required to Test") of a May 20, 1987
proposed TSCA §4 test rule (52 FR 19107) for cyclohexane presents
the following statements regarding chemical processors:
11.. . Processors are required to test if the findings are
based on processors ("process" is defined in section 3(10) of
TSCA as the preparation of a chemical substance or mixture,
after its manufacture, for distribution in commerce)..."
CORRESPONDENCE
A September 13, 1979 letter from Warren Muir, DAA for the
Office of Testing and Evaluation (OTE) of OTS/EPA to Karim Ahmed of
the Natural Resources Defense Council (NRDC) contained a
"Discussion Issue" paper which that presents a discussion of the
subject: "How should the term "processor" be defined for purposes
of TSCA section 4 rules?". This processor-related discussion is
quoted below:
"The term 'process1 as defined in section 3(10) of TSCA means
"the preparation of a chemical substance or mixture, after its
manufacturers, for distribution in commerce—
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11 (A) in the same form or physical state as, or
in a different form or physical state from,
that in which it was received by the person so
preparing such substance or mixture, or
11 (B) as part of an article containing the
chemical substance or mixture.
"Under that definition, many persons could be required to test
a chemical, including people who might not normally be
considered processors as that term is used by the chemical
industry. It appears clear, for instance, that Company X is
a processor of chemicals A and B if it mixes A and B to make
a mixture A/B, and that Company Y is a processor of a resin if
it uses the resin to coat the inside of the cans it
distributes. Under the statutory definition, distributors who
repackage bulk chemicals in smaller containers for consumer
use, merchants who tint and mix paints, printers, firms that
extrude plastics or other materials, and firms that paint or
coat materials prior to sale could be required to test as
processors or seek an exemption from testing.
"This result suggests substantial practical problems because
many thousands of people could be required to test, including
many persons who are not connected to the chemical industry.
Should EPA therefore limit the number of type of "processors"
subject to a §4 test rule? If so, how should this be done?
What ^are the implications for test rules, exemptions, and
reimbursement?"
A December 19, 1979 letter from EPA to Melvin C. Laracey,
Esq., Consumers Power Company of Jackson, Michigan provides the
following processor-related information:
"We interpret the term 'use for commercial purposes' to
cover potentially any use by a person who is involved in
a commercial activity as opposed to a charitable or
private and personal activity. In the context of section
15 of the Act, the term would cover, among other things,
activities which meet the definition of 'processing1 as
well as activities which result in the ultimate
'consumption' of the chemicals.
11 ... An example of "using for a commercial purpose"
that is also "processing" within the meaning of the Act
is incorporation of a chemical substance into a mixture
or article. . . "
[The remaining page(s) of this EPA letter was not found.]
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
August 2, 1989
Patrick J. Kurd
Keller and Heckman
1150 17th Street N.W.
Suite 1000
Washington, D.C. 20036
Dear Mr. Kurd:
I have received your June 15, 1989 letter: requesting
clarification of the application of Section 4 of the Toxic
Substances Control Act (TSCA) to certain activities of National
Paint and Coatings Association (NPCA) members and whether they are
treated as "processing" under this section. Processors along with
manufacturers are specified in section 4(b)(3)(B) as classes of
persons potentially covered by section 4.
According .to section 4(b)(3)(B), the applicability of a
specific test rule to either "manufacturers" or "processors" depends
on the findings on which the test rule is based. Manufacturers are
covered if the test rule finding is based on manufacturing opera-
tions, processors are covered if the test rule finding is based on
processing activities, and both manufacturers and processors are
covered if test rule findings are based on distribution in commerce,
use, or disposal of the substance or mixture. The terms "manufac-
turer" and "processor" are defined by TSCA and its regulations.
The term "process" is defined in section 3 of TSCA as;
". . . the preparation of a chemical substance or mixture,
after its manufacture, for distribution in commerce-
(A) in the same form or physical state as, or in a
different form or physical state from, that in which it is
received by the person so preparing such substance or mixture,
or
(B) as part of an article containing the chemical
substance or mixture."
Using this definition, we can evaluate the three examples presented
in your letter as to their status as "processors".
To evaluate whether an activity constitutes processing under
TSCA, EPA looks at whether there is "preparation" of a chemical
substance or mixture and whether that preparation is "for
distribution in commerce." Application of a coating constitutes
"preparation" and may constitute distribution in commerce under some
circumstances. Both elements must be present to be considered
processing.
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In the first example in your letter, the addition of a tint or
colorant to containers of paints containing a substance subject to
a section 4 test rule at a retail store would make the retail store
a "processor" under TSCA. Clearly in this case there is a "prepara-
tion" of a chemical substance or mixture, by further addition of
ingredients, for distribution in commerce (i.e. sale to consumers)
in the same form or physical state as that in which it is received
by the person preparing the substance or mixture.
I will address the third example before addressing the second
example. The application of finished industrial coatings in original
equipment manufacturing facilities to appliances, automobiles, or
heavy equipment is clearly processing. The equipment in question is
being prepared for distribution in commerce. The application of
coatings to that equipment is part of the preparation for distribu-
tion in commerce. Thus the substances in such coatings are prepared
for distribution in commerce as part of the equipment. The form or
physical state of the substances in the coatings is likely to change
during such processing, i.e. during curing or drying (any substance
in the coating which evaporates upon application and therefore does
not remain in the coating or on the equipment would not be distri-
buted in commerce with the equipment and therefore would not be
processed).
With respect to the second example, the spray application of an
automotive refinish coating containing a substance subject to a
section 4 test rule may constitute processing depending upon the
circumstances. EPA has identified three circumstances in which a
person would be applying automotive refinish coatings. In one
circumstance an individual is applying the refinish coatings in the
course of repairing or repainting the individual's own car. In the
second circumstance a person is in the business of applying such
coatings in the course of repairing or repainting cars owned by
individuals. In the third circumstance, a person is in the business
of repairing or repainting cars for resale purposes (the cars may be
owned by the person or another person).
First, with respect to individuals applying such coatings to
their own cars, there is no processing as that term is used in TSCA,
because whether or not the individuals are preparing the coating,
they are not preparing the cars for distribution in commerce.
Because they already own the cars, the cars are not being further
distributed in commerce. Thus, even if the individual mixes the
coating in some fashion before application,the individual is not
engaged in preparation for.distribution in commerce.
Second, with respect to a person engaged in the business of
applying such a coating in the course of repairing or repainting a
car owned by an individual, whether the person is a processor
depends on the circumstances of the coating application. A person
engaged in the business of applying coatings to cars is distributing
such coatings in commerce just as a person who sells coatings
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without the additional service of applying them would be. The person
would be a processor of the substance in the coating if the person
engages in preparing the coating material (for example, adding
pigments or solvents, but not stirring the coating or transferring
the coating from its container to the spray equipment) before
applying it, because such activities would constitute preparation
for distribution in commerce. However, the person would not be (a
processor if the person only applies a coating which the person
obtains from another (without further preparation of the coating on
of the coating other than stirring or placing it into spray equip-
ment) because there is no preparation of the coating by the person
before it is distributed in commerce (i.e. the act of sale to the
individual car owner) . In this circumstance, the car is owned by the
end user and is not being further distributed in commerce. Thus, the
coating is not being prepared for distribution in commerce as part
of the car as is the case in the circumstances discussed below and
in response to your third example.
Third, with respect to a person engaged in the business of
applying such coatings in the course of repairing or repainting cars
for resale, this would be the same situation as a person applying
industrial coatings to original equipment discussed above. Such a
person would be processing the substances in the coating by pre-
paring the cars.for distribution in commerce. The substances in the
coating would be prepared for distribution in commerce as part of
the repainted car.
The other issue presented in your letter is the impact of 40
CFR section 790.48(b). This section is clear in attributing TSCA
section 15 violations to manufacturers and processors who do not
submit notices of intent to test (or exemption applications) when
they are required to under a test rule. I should point out that the
penalties provided for in section 16 of TSCA for violations of
section 4 test rules do not involve the further prohibition of manu-
facture or processing of such chemicals.
It has been EPA's experience under section 4 that manufacturers
end up doing the testing in most test rules and seldom, if ever,
seek reimbursement from processors under section 4. More likely is
that the cost of testing recouped by passing the test costs on in
the cost of the affected products. Thus, I do not believe that
members of the National Paint and Coatings Association who are
processors as described above are likely to be directly affected by
section 4 rule requirements involving substances used in their
paints and coatings.
Sincerely yours,
Charles L. Elkins
Director
Office of Toxic Substances
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S5 ("MANUFACTURING AND PROCESSING NOTICES."1
"PMNs"
TSCA (THE ACT)
According to §5(a)(l)(A) of TSCA, no person (unless otherwise
exempted in accordance with §5(h)) may ". . . manufacture a new
chemical substance on or after the 30th day after the date the
Administrator first publisheds the list required by section 8(b)."
CODE OF FEDERAL REGULATIONS (CFR)
Part 720 — Premanufacture Notification
Subpart A - General Provisions
According to 40 CFR §720.3(c), "'Article' means a manufactured
item (1) which is formed to a specific shape or design during
manufacture, (2) which has end use function(s) dependent in whole or
in part upon its shape or design during end use, and (3) which has
either no change of composition during its end use or only those
changes of composition which have no commercial purpose separate
from that of the article and that may occur as described in
§720.36(g)(5) [sic - misprint, should be §720.30(h)], except that
fluids and particles are not considered articles regardless of shape
or design."
According to 40 CFR §720.3(n), "'Intermediate1 means any
chemical substance that is consumed, in whole or in . part, in
chemical reactions used for the intentional manufacture of another
chemical substance(s) or mixture(s), or that is intentionally
present for the purpose of altering the rates of such chemical
reactions."
According to 40 CFR §721.3(r), "'Manufacture or import for
commercial purposes' means:
" (1) To import, produce, or manufacture with the purpose
of obtaining an immediate or eventual commercial advantage for
the manufacturer or importer, and includes, among other things,
'manufacture' of any amount of a chemical substance or mixture:
"(i) For commercial distribution, including for test
marketing.
"(ii) For use by the manufacturer, including use for
product research and development or as an intermediate.
"(2) The term also applies to substances that are produced
coincidentally during the manufacture, processing, use, or
disposal of another substance or mixture, including byproducts
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that are separated from that other substance or mixture and
impurities that remain in that substance or mixture. Bypro-
ducts and impurities without separate commercial value are
nonetheless produced for the purpose of obtaining a commercial
advantage, since they are part of the manufacture of a chemical
substance for commercial purposes."
According to 40 CFR §720.3(s), "'Manufacture solely for export1
means to manufacture or import for commercial purposes a chemical
substance solely for export from the United States under the
following restrictions on activities in the United States:
11 (1) Distribution in commerce is limited to purposes of
export or processing solely for export as defined in §721.3 of
this chapter.
"(2) The manufacturer or importer, and any person to whom
the substance is distributed for purposes of export or
processing solely for export (as defined in §721.3 of this
chapter), may not use the substance except in small quantities
solely for research and development in accordance with
§720.36."
According to 40 CFR §720.3(aa), the term "Process" means "the
preparation of a chemical substance or mixture, after its manu-
facture, for distribution in commerce (1) in the same form or
physical state as, or in a different form or physical state from,
that in which it was received by the person so preparing such
substance or mixture, or (2) as part of a mixture or article
containing the chemical substance or mixture."
According to 40 CFR §720.3 (bb), the term "Processor" means any
person who processes a chemical substance or mixture."
Part 720 — Premanufacture Notification
Subpart B - Applicability
According to 40 CFR §720.30(h) , the following chemicals are not
subject to the premanufacture notification requirements: "The
chemical substances described below: (Although they are manufactured
for commercial purposes under the Act, they are not manufactured for
distribution in commerce as chemical substances per se and have no
commercial purpose separate from the substance, mixture, or article
of which they are a part.)
"(1) Any impurity.
"(2) Any byproduct which is not used for commercial
purposes.
"(3) Any chemical substance which results from a chemical
reaction which occurs incidental to exposure of another
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chemical substance, mixture, or article to environmental
factors such as air, moisture, microbial organisms, or
sunlight.
"(4) Any chemical substance which results from a chemical
reaction that occurs incidental to storage or disposal of
another chemical substance, mixture, or article.
"(5) Any chemical substance which results from a chemical
reaction that occurs upon end use of another chemical
substance, mixture, or article such as an adhesive, paint,
miscellaneous cleanser or other housekeeping product, fuel
additive, water softening and treatment agent, photographic
film, battery, match, or safety flare, and which is not itself
manufactured or imported for distribution in commerce or for
use as an intermediate.
"(6) Any chemical substance which results from a chemical
reaction that occurs upon use of curable plastic or rubber
molding compounds, inks, drying oils, metal finishing
compounds, adhesives, or paints, or any other chemical
substance formed during the manufacture of an article destined
for the marketplace without further chemical change of the
chemical substance except for those chemical changes that occur
as described elsewhere in this paragraph.
"(7) Any chemical substance which results from a chemical
reaction that occurs when (i) a stabilizer, colorant, odorant,
antioxidant, filler, solvent, carrier, surfactant, plasticizer,
corrosion inhibitor, antifoamer or defoamer, dispersant,
precipitation inhibitor, binder, emulsifier, deemulsifier,
dewatering agent, agglomerating agent, adhesion promoter, flow
modifier, pH neutralizer, sequesterant, coagulant, chelating
agent, or quality control reagent functions as intended, or
(ii) a chemical substance, which is intended solely to impart
a specific physiochemical characteristic, functions as
intended.
"(8) Any nonisolated intermediate."
Part 723 — Premanufacture Notification Exemptions
Subpart B - Specific Exemptions
According to 40 CFR §723.175(b)(2), the term "article" means "a
manufactured item (i) which is formed to a specific shape or design
during manufacture, (ii) which has end use function(s) dependent in
whole or in part upon its shape or design during end use, and (iii)
which has either no change of chemical composition during its end
use or only those changes of composition which have no commercial
purpose separate from that of the article and that may occur as
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described in §710.2 of this chapter except that fluids and particles
are not considered articles regardless of shape or design."
According to 40 CFR §723.175(b) (15) , the term "'Used in the
manufacturing or processing of an instant photographic or peel-apart
article1 when used to describe activities involving a new chemical
substance, means the new chemical substance (i) is included in the
article, or (ii) is an intermediate to a chemical substance included
in the article or is one of a series of intermediates used to
manufacture a chemical substance included in the article."
PROPOSED RULE Premanufacture Review Program
Proposed Processor Requirements
45 Fed. Reg. 54642 (15 August 1980)
11 . . . 'Commercial purposes' includes the purposes of
distribution in commerce and use as an intermediate . . .
•Process,' 'process for commercial purposes,' and
•processor' . . . include the preparation of a chemical
substance or mixture in the same or a different form or
physical state from that in which it was received."
Id., at 54647:
"There are two scenarios in which a facility treating a
byproduct which is a hazardous waste under RCRA may fall
under TSCA. First, if such a facility treats a byproduct
containing a new chemical substance and the facility
extracts the new chemical substance for sale in commerce,
it would be processing the exempt substance (the by-
product) for a nonexempt commercial purpose. However, in
this case the facility also would be the manufacturer of
the new chemical substance and thus would be required to
submit a notice under TSCA section 5(a)(1)(A) (even if
there is no processor notification rule). Second, if the
facility treats a byproduct containing a new chemical
substance and processes the byproduct to produce another
chemical (not a new substance) for distribution in com-
merce, it would be required to notify EPA under this
proposed rule-as a processor
"As proposed, this processor notification rule would
require reporting by facilities treating hazardous wastes
when the wastes they treat are byproducts and are
processed for a nonexempt commercial purpose."
Id., at 54650
"As noted above, persons who only use chemical substances
for a commercial purpose and do not process or manufacture
them are not themselves subject to the section 5
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premanufacture notification requirement. However, 30 days
after publication of the Revised Inventory, and prior to
the promulgation of the final processor notification rule,
EPA will apply TSCA section 15(2) to users of chemical
substances manufactured for a nonexempt commercial
purpose. (If this nonexempt substance were processed
before use, the Agency would still apply section 15(2) to
the users.)"
OTHER ROLES
PROPOSED RULE 49 Fed. Reg. 50207 (27 December 1984):
"To be manufactured solely for export, a chemical sub-
stance may be processed only by the manufacturer or
importer. Since the substance cannot be used in the U.S.
by any person, such processing is limited to processing
that does not involve use. In general, export-only
processing is limited to preparing the substance, either
alone or as part of a mixture, for export and can include
formulating a mixture and packaging the product. If the
new chemical substance is an intermediate to be used in
the U.S. to make another chemical intended for export, the
new intermediate is not manufactured solely for export
because it is used in the U.S. Other types of processing,
such as dyeing fabric or incorporating a substance into an
article, would also constitute use and, thus, would
require a PMN before the activity could take place."
FINAL RULE 51 Fed. Reg. 15100 (22 April 1986):
"Section 12 (a) of TSCA exempts from PMN new chemical sub-
stances which are manufactured or processed for export
only and will not be used in the U.S. The proposed
revision of § 720.3(s) would have limited processing to
activities occurring under the control of the manufacturer
or importer. In this final rule, EPA modifies the defini-
tion of the term 'manufacture solely for export1 to
include processing which is not under the direct control
of a manufacturer or importer, as long as it occurs solely
for export. (The rule cross-references the definition of
•process solely for export1 in 40 CFR 721.3.) However,
the manufacturer must know, by means of a contract or some
other evidence, that the processing is occurring for
export only. For substances to qualify as export-only
chemicals, their processing must also be limited to
activities which do not involve use. For example,
formulating a mixture constitutes a legitimate form of
processing for export-only chemicals, but their use as
intermediates in chemical production does not."
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EPA CORRESPONDENCE
The following is excerpted from a sanitized October 20, 1987 letter
from Stephanie G. Roan (CCD/OTS) regarding the application of a new
chemical finish to a fiber to enhance its qualities when the fiber
is later formed into a fabric. The company argued that the finish
was not "used" until the exported fiber was turned into a fabric
outside the United States, because the qualities imparted by the
finish were not utilized until then. The Agency disagreed, con-
cluding that the application process itself constituted a 'use1 of
the finishing chemical, and that a PMN would be required for the
chemical. The letter states as follows:
"The statute and regulations do not define 'use.1 How-
ever, Merriam Webster's Ninth Collegiate Dictionary
defines 'use1 as 'the act or practice of employing
something: EMPLOYMENT, APPLICATION . . . [,] a method or
manner of employing or applying something . . . [,] a
particular service or end.' Throughout your letter, in
describing the process at issue here, you employ the words
'apply,' 'applied,' and 'application,1 which, according to
Webster's Dictionary, are synonyms for 'use.1 In applying
the [CBI] to the [CBI] fibers, [CBI] would be using the
substance for a commercial purpose to increase the
marketability of the product in order to obtain financial
benefit. Therefore, we believe that the process that you
describe in your letter constitutes 'use in the United
States' which, according to the above provisions, is
ineligible for the export exemption."
Letter from Stephanie G. Roan to Anne B. Sayigh of Parexel
International Corporation, 11 December 1987:
"This replies to your September 25, 1987 letter to Mr.
Dayton Eckerson regarding the premanufacture notification
(PMN) requirements for a new chemical substance in a
coating of thermal transfer film ribbon which is imported
into the United States. You state your opinion that the
new chemical substance is imported 'as part of an article'
(i.e., the ribbon) and therefore is not subject to the PMN
requirements.
"According to your letter, the ink coating, which contains
the new chemical substance, is deposited onto paper during
use. It is the Agency's policy that a chemical substance
is not 'part of an article1 where (1) the article is a
container of "the substance used to transport, contain,
and/or dispense it, and/or (2) the substance is intended
to be removed (or released) from the article and has an
end use or commercial purpose separate from the article.
A substance which is intended to be removed or released
from its article/container, and serves a function during
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use related to the removal/release of the substance, is
considered to have an end use or commercial purpose
separate from the article. Since the new chemical
substance is intended to be released from the ribbon and
serves a function during use related to the release, it is
not 'part of an article1 and would not be excluded from
the PMN requirements. The question of whether or not a
chemical reaction occurs during deposition of the ink onto
the paper is not the determining factor here, since the
ink containing the new chemical substance is clearly
intended to be released from the ribbon."
Letter from Stephanie G. Roan to Braden R. Allenby of AT&T, 3 May
1988:
"This replies to your January 12, 1988 letter regarding
the applicability of the Toxic Substances Control Act
section 5(h)(3) research and development (R&D) exemption
for a new chemical substance which is used as a quality
control indicator to test the integrity of circuit boards.
"You correctly conclude that the R&D exemption from the
premanufacture notification (PNM) requirements is
applicable to the new chemical substance since AT&T
produces the quality control indicator solely to test the
performance characteristics of the circuit board and
complies with all the requirements of the R&D rule (40 CFR
720.36 and 720.78) . Further, I agree that AT&T is free to
distribute the circuit boards (articles) incorporating the
quality control indicator in commerce after the R&D
activity is completed, without submitting a PMN for the
new chemical substance, in accordance with 40 CFR 720.36
(d) and (f)."
Letter from Stephanie G. Roan to Braden R. Allenby of AT&T, 13 May
1988:
"This replies to your February 17, 1988 letter seeking
confirmation of AT&T's understanding of the Agency's
policy regarding the applicability of the Toxic Substances
Control Act section 5 premanufacture notification (PMN)
requirements to chemical substances imported 'as part of
an article.'
"In your letter,, you correctly conclude that 'a substance
must not be intended to be removed from the article as a
result of anticipated use, and the substance cannot have
a commercial end use function separate from the article,'
in order to be considered 'part of an article.' Further,
I agree that the material in a vented capacitor, the
mercury compound in a relay switch, and the electrolytes
contained in wet cell batteries, as described in your
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letter, are not subject to the PMN requirements, since the
chemical substances are not intended to be released from
the articles during normal use and have no function
separate from their function in the articles. Although
the chemical substances may be removed or released from
the articles during use, the removal or release serves no
end use function. The chemical substances are considered
to be 'part of the article, and therefore are excluded
from the PMN requirements at 40 CFR 720.22(b)(1)."
Letter from Carol Hetfield to Daniel J. Manelli of Graham & James,
copy undated (late 1988 or early 1989):
"In your letter, you ask for a clarification of whether
the Environmental Protection Agency (EPA) would consider
brake linings, brake disc pads, drum brakes, automobile
bumpers, clutch facings, and automobiles as articles for
purposes of the Toxic Substances Control Act (TSCA).
Referring to comment 21 of the Inventory Reporting
Requirement (42 FR 64583) , EPA responded to the issue of
the importation of chemical substances as part of articles
by stating:
"'Chemical substances or mixtures which are
imported within articles, such as in drums,
barrels, or other containers used for purposes
of transportation or containment are considered
to be chemical substances imported in bulk and
are subject to these reporting requirements.
Chemical substances or mixtures will be
considered to be imported as part of an
article, if the substance or mixture is not
intended to be removed from that article and
has no end use or commercial purpose separate
from the article of which it is a part.'
"In other words, even particles such as those found in
brake linings are exempt from Inventory or PMN reporting
when imported as components of articles, provided the
articles which they accompany in commerce are not solely
containers for them, and they are not intended to be
released during use, and do not serve a function during
use that is related to their release. Therefore, EPA
would agree that all the above manufactured items would
meet the definition of article at 40 CFR Part 720.3 (c) and
would not be subject to Premanufacture Notification
reporting requirements. In addition, importers of
articles are not required to certify their shipment
according to section 13 of TSCA unless a rule under TSCA
specifically requires them to do so."
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Letter from Mary E. Cushmac to Hiroshi Uyama of Japan Technical
Information Center Inc., 2 May 1989:
"This responds to your letter, dated February 28, 1989,
regarding the applicability of the premanufacture
notification (PMN) requirements to a new polymer used to
coat magnetic carriers that carry toner particles in
photocopying operations. You also inquired about the PMN
status of constituents of a laundry detergent that is
imported in retail packages.
"According to your letter, the magnetic carriers coated
with the polymer release the toner particles and are
recycled and not released from the photocopying system.
It is not clear from the information provided in your
letter whether or not the carriers are 'part of an
article1 and you may wish to provide a more complete
description for our review. However, it appears that the
magnetic carriers themselves would be viewed as
'particles' rather than as 'articles' because of their
size (100 microns) and the lack of evidence that they meet
the specific criteria set forth in the definition of an
article at 40 CFR 720.3(c). Consequently, the polymer
would not be viewed 'as part of an article' and would
therefore be subject to the PMN requirements if it is not
included in the TSCA Inventory.
"Further, any new chemical substance in the laundry
detergent would be subject to the PMN requirements, since
the laundry detergent would be viewed as a mixture. Any
chemical substance that is manufactured (imported) solely
for a use that comes under the authority of the Food and
Drug Administration, would not be subject to TSCA."
Letter from Lawrence W. Culleen to John H. Gray of Dow Chemical
Corporation, 28 June 1989:
"This responds to your two letters . . . regarding the
applicability of the Toxic Substances Control Act (TSCA)
to Dow's proposed large-scale recycling of rigid plastic
containers to recover polyethylene and polyethylene
terephthalate (PET) . . .
"For both sources identified above, Dow intends to grind
the containers into granules and recover polyethylene and
PET through a number of physical separations and cleaning
operations. No chemical reactions would occur. EPA
agrees that these operations constitute 'processing' for
purposes of TSCA."
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Letter from Mary E. Cushmac to James R. Keith of Dow Chemical
Company, 12 December 1989:
"This responds to your letter, dated September 28, 1989,
seeking additional guidance regarding the applicability of
the Toxic Substances Control Act (TSCA) premanufacture
notification (PMN) requirements to Dow1 s proposed plastics
recycling activities. . . In this letter, you describe
Dow's proposed recycling of plastic parts made from
thermoset plastic-like polyurethanes. As an example, Dow
plans to grind off-spec parts or scrap from an automotive
molding operation into a powder and use it as a filler in
the injection molding of other articles.
"Based on our analysis of the information provided in your
letter and the Office of Toxic Substances' previous
guidance, the off-spec material/scrap which was lawfully
manufactured during the manufacture of articles can be
processed and used as a filler without the submission of
a PMN. As you were previously advised, OTS agrees with
Dow's rationale that section 15(2) of TSCA says that
processors are not in violation unless a chemical sub-
stance was actually illegally manufactured."
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"SNURs1
TSCA (THE ACT)
According to §5(a)(1)(B) of TSCA, no person (unless otherwise
exempted in accordance with §5(h)) may "... process any chemical
substance for a use which the Administrator has determined ... is
a significant new use ..."
According to TSCA §5(i) ["DEFINITION."], the term "process"
means "processing for commercial purposes."
§5 of TSCA does not provide a separate definition for the term
"process(ing) for commercial purposes."
CODE OF FEDERAL REGULATIONS (CFR)
Part 721 — Significant New Uses of Chemical Substances
Subpart A - General Provisions
According to 40 CFR §721.3, the term "Process for commercial
purposes" means "the preparation of a chemical substance or mixture
containing the chemical substance, after manufacture of the sub-
stance, for distribution in commerce with the purpose of obtaining
an immediate or eventual commercial advantage for the processor.
Processing of any amount of a chemical substance or mixture con-
taining the chemical substance is included in this definition. If
a chemical substance or mixture containing impurities is processed
for commercial purposes, the impurities also are processed for
commercial purposes."
According to 40 CFR §721.3, the term "Process solely for
export" means "to process for commercial purposes solely for export
from the United States under the following restrictions on activity
in the United States: Processing must be performed at sites under
the control of the processor; distribution in commerce is limited to
purposes of export; and the processor may not use the chemical
substance except in small quantities solely for research and
development."
QUESTION AND ANSWER DOCUMENTS
A July 25, 1986 "Question and Answer Summary" prepared by EPA
following a June 10, 1986 Agency-sponsored seminar on the industry
obligations under TSCA presents the following with regard to the
term processor under a significant new use rule (SNUR) issued by the
Agency under §5(a)(2) of TSCA:
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"Question; To what extent are the [§5] SNUR requirements
applicable to manufacturers of inadvertently generated
ingredients (e.g., a particular ingredient is an inactive
ingredient as part of the major product component)?
"Answer; SNUR requirements apply to ... processors of
specific chemical substances listed in the SNUR. If a
company intends to ... process for commercial purposes
a chemical substance listed in a SNUR for a significant
new use designated in that rule, the company is subject to
the SNUR. EPA has established certain exemptions to
SNURs, codified at 40 CFR § 721.19, including the . . .
processing of a SNUR chemical solely as an impurity or
byproduct (see §721.19 for exact language) "
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S6 ("REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES."1
TSCA (THE ACT)
According to §6(a) of TSCA ("SCOPE OF REGULATION"), "If the
Administrator finds that there is a reasonable basis to conclude
that the . . . processing ... of a chemical substance or mixture
. . . presents or will present an unreasonable risk of injury to
health or the environment, the Administrator shall by rule apply one
or more of the following requirements to such substance or mixture
to the extent necessary to protect adequately against such risk
using the least burdensome requirement:
"(1) A requirement (A) prohibiting the . . . processing .
. . of such substance or mixture, or (B) limiting the
amount of such substance or mixture which may be ...
processed ...
"(2) A requirement (A) prohibiting the . . . processing .
. . of such substance or mixture for (i) a particular use
or (ii) a particular use in a concentration in excess of
a level specified by the Administrator in the rule
imposing the requirement, or (B) limiting the amount of
such substance or mixture which may be ... processed .
. . for (i) a particular use or (ii) a particular use in
a concentration in excess of a level specified by the
Administrator in the rule imposing the requirement.
"(3) A requirement that such substance or mixture or any
article containing such substance or mixture be marked
with or accompanied by clear and adequate warnings and
instructions . . . prescribed by the Administrator.
" "(4) A requirement that . . . processors of such substance
or mixture make and retain records of the processes used
to ... process such substance or mixture and monitor or
conduct tests which are reasonable and necessary to assure
compliance with the requirements of any rule under this
subsection
"(6)(A) A requirement prohibiting or otherwise regulating
any manner or method of disposal of such substance or mix-
ture, or any article containing such substance or mixture
by its . . . processor
"(7) A requirement directing . . . processors of such sub-
stance or mixture (A) to give notice of such unreasonable
risk of injury ... [to distributors and others in pos-
session of or exposed to the substance or mixture], (B) to
give public notice of such risk of injury, and (C) to
replace or repurchase such substance or mixture as elected
by the person to which the requirement is directed."
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According to §6(b) of TSCA ("QUALITY CONTROL"), "If the
Administrator has a reasonable basis to conclude that a particular
. . . processor is manufacturing or processing a chemical substance
or mixture in a manner which unintentionally causes the chemical
substance or mixture to present or which will cause it to present an
unreasonable risk of injury to health or the environment —
11 (1) the Administrator may by order require such . . .
processor to submit a description of the relevant quality
control procedures followed in the manufacturing or
processing of such chemical substance or mixture; and
"(2) if the Administrator determines —
(A) that such quality control procedures are
inadequate to prevent the chemical substance or
mixture from presenting such risk of injury, the
Administrator may order . . . the processor to
revise such quality control procedures to the extent
necessary to remedy such inadequacy; or
(B) that the use of such quality control procedures
has resulted in the distribution in commerce of
chemical substances or mixtures which present an
unreasonable risk of injury to health or the
environment, the Administrator may order the . . .
processor to to (i) give notice of such risk to
processors or distributors in commerce of any such
substance or mixture, or to both, and, to the extent
reasonably ascertainable, to any other person in
possession of or exposed to any such substance, (ii)
to give public notice of such risk, and (iii) to
provide such replacement or repurchase of any such
substance or mixture as is necessary to adequately
protect health or the environment.
"A determination under subparagraph (A) or (B) of
paragraph (2) shall be made on the record after
opportunity for hearing in accordance with section 554 of
title 5, United States Code. Any . . . processor subject
to a requirement to replace or repurchase a chemical
substance or mixture may elect either to replace or
repurchase the substance or mixture and shall take either
such action in the manner described by the Administrator."
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POLYCHLORINATED BIPHENYLS (PCBs)
CODE OF FEDERAL REGULATIONS (CFR)
Part 761 — Polychlorinated Biphenyls (PCBs) Manufacturing.
Processing. Distribution in Commerce, and Use Prohibitions
Subpart A - General
According to 40 CFR §761.3, a "PCB Article" means "any
manufactured article, other than a PCB Container, that contains PCBs
and whose surface(s) has been in direct contact with PCBs. "PCB
Article" includes capacitors, transformers, electric motors, pumps,
pipes, and any other manufactured item (1) which is formed to a
specific shape or design during manufacture, (2) which has end use
function(s) dependent in whole or in part upon its shape or design
during end use, and (3) which has either no change of chemical
composition during its end use or only those changes of composition
which have no commercial purpose separate from that of the PCB
Article."
40 CFR §761.3 states further that the term "Process" means "the
preparation of a chemical substance or mixture, after its
manufacture, for distribution in commerce: (1) in the same form or
physical state as, or in a different form or physical state from,
that in which it was received by the person so preparing such
substance or mixture, or (2) as part of an article containing
thehemical substance or mixture."
WORDING FROM THE ACT
§ 6 REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES.
(e) POLYCHLORINATED BIPHENYLS
Section 6(e) of TSCA requires that within six months after the
effective date of the Act the Administrator shall promulgate
regulations to —
(1)(B) Provide "... instructions with respect to their
processing, distribution in commerce, use, or disposal or with
respect to any combination of such activities."
(2) (A) "... effective one year after the effective date of this
Act no person may manufacture, process, or distribute in commerce or
use any polychlorinated biphenyl in a manner other than in a totally
enclosed manner."
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(B) "The Administrator may by rule authorize the manufacture,
processing, distribution in commerce or use (or any combination of
such activities) of any polychlorinated biphenyl ..." if he finds
that it will not present an unreasonable risk to human health or the
environment.
(3)(A) "Except as provided in subparagraphs (B) and (C) —
(ii) no person may process or distribute in commerce any poly-
chlorinated biphenyl after two and one-half years after such date."
The Act allows any person to petition the Administrator for an
exemption from the above requirements. The Administrator may grant
or deny this petition by rule.
WORDING FROM FEDERAL REGISTER NOTICES
?? FR June 7. 1978 - Proposed Rule (40 CFR Part 761)
Polychlorinated Biphenyls (PCBs); Manufacturing, Processing,
Distribution in Commerce, and Use Bans
Preamble, page 24805
"Manufacture and Process for Commercial Purposes. The proposed
rule applies to manufacturing (including importation) and pro-
cessing which is performed for commercial purposes. *Commercial
Purposes' means for distribution in commerce, including for test
marketing purposes, and for use by the manufacturer, including for
use as a chemical precursor. By restricting the scope of the
definitions of * manufacture' and ^processing' found in TSCA to
apply to only those activities that are considered *for commercial
purposes', EPA would not regulate certain activities such as the
manufacture of a chemical that results in an unintentional PCB
impurity. However, because the proposed rule prohibits the
distribution in commerce of PCB mixtures, the product would have to
be processed to reduce the PCB concentration to below 50 ppm before
distribution in commerce. The proposal would also permit the
processing of products and plant wastes to concentrate PCBs if the
purpose is to dispose of the PCBs and reduce the PCB concentration
in the final product."
Preamble, page 24807 (column 1)
"According to section 6(e) of TSCA, disposal is an activity
separate from processing and distribution in commerce. Any prepara-
tion or processing for disposal is considered to be disposal and
not distribution in commerce or processing. Therefore, any such
activity, if in the course of compliance with pertinent disposal
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requirements, is not subject either to the January 1, 1978, totally
enclosed manner requirements or to the July 1, 1979, bans."
Preamble, page 24807 (column 2)
"NOTE: - The term *distribution in commerce1 is used to refer
to the sale of a PCB. However, it also means the delivery of a PCB
in conjunction with a sale for purposes of resale. An example of
the latter is a distributor who buys from the manufacturer and then
resells to retailers; while the PCBs are in his inventory, they are
being held for further distribution in commerce. However,
distribution in commerce does not include the holding of PCBs for
purposes solely of use by the holder. For purposes of TSCA,
xprocessing' is limited to that processing which takes place after
manufacture of the PCB in preparation for distribution in commerce.
xProcessing1 does not include processing performed by the owner of
the PCB subsequent to distribution in commerce for his own use.
The servicing of a PCB transformer is an example of how all
these concepts fit together. If a PCB transformer is removed from
service and returned to the owner's own service shop where the PCB
dielectric fluid is added to it, the servicing could be covered by
a use authorization. However, if that same transformer was sent to
a transformer service company that added PCBs to the transformer,
the servicing would be both processing and distribution in commerce
since the PCB dielectric fluid would be sold by the service company
to the transformer owner (thus the title to the PCBs would have
passed from one owner to another). To continue this activity, the
transformer service company would need authorizations for both
processing and distribution in commerce. In addition, the service
company would have to petition for, and receive, an exemption each
year to continue this activity after June 30, 1979. Even though
the actions performed in each shop are the same, the transformer
service company is subject to much more rigorous requirements than
the transformer owner.
As in the transformer servicing example above, a person
servicing a computer who does not own that computer is considered
to be processing and distributing in commerce if he installs a PCB
capacitor in the computer. To continue that practice after July 1,
1979, an exemption will be required. Finally, a person who leases
a computer may not sell that computer after July 1, 1979, unless
the computer has been leased for no less than one year. A person
could apply for an exemption so that he could sell a computer which
has been leased for less than one year."
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FR Mav 31. 1979 - Final Rule (40 CFR Part 761)
(Polychlorinated Biphenyls (PCBs) Manufacturing, Processing,
Distribution in Commerce, and Use Prohibitions)
Preamble, page 31525
"Manufacturing" Versus "Processing" of PCB Items
"After considering the comments, EPA reexamined the ^manufacturing'
versus *processing1 issue and concluded that PCB Article and PCB
Equipment production is 'processing* of PCBs» not 'manufacture* of
PCBs. This conclusion is based on an analysis of the activities of
manufacturing, processing, distribution in commerce, and use with
respect to chemical substances. EPA determined that
*manufacturing1 a chemical substance involves only the actual
creation of the chemical substance (or of a substance contaminated
with PCBs). The other activities are distinguished from
xmanufacturing' because they involve the use of the already
existing substance. *Processing1 PCBs includes activities such as
placing previously manufactured PCBs into capac i tor s or
transformers. While these activities may be referred to as
xmanufacturing' of PCB Articles, they do not involve the
Manufacture1 of the PCBs, only the * processing1 of PCBs. The
^distribution in commerce1 and *use' of PCBs generally coincides
with the distribution and use of the PCB Articles and PCB
Equipment. Thus, the ban of PCB ^manufacture1 applies solely to
the manufacture of PCBs, as defined in §761.2 (a). Bans of all
other activities, namely processing, distribution in commerce, and
use, apply both to PCBs as a substance and PCB Items. This
interpretation of the terms ^manufacture' and ^process' also
accords with the manner in which Congress intended the requirements
of section 6(e)(3) of TSCA to be %phased-in' over time.
The change in EPA's use of the terms xmanufacturing' and
^processing', is reflected in the definition of PCBs. The proposed
definition of ^PCB* and xPCBs' is included in both PCB Article and
PCB Equipment (see § 761.2 (q) at 43 FR 24813). The final rule
changes the definition of *PCB' and *PCBs' in § 761.2 (s) by
applying these terms only to chemical substances (see preamble
II.A. for more detailed discussion). PCB Equipment and PCB
Articles are no longer included in the definition of XPCB' and
'PCBs' but are included in a separate term, XPCB Items,1 which is
defined in § 761.2(x)."
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FR May 31. 1979 - Interim Procedures (40 CFR Part 750)
(Procedures for Rulemaking Under Section 6 of the Toxic Substances
Control Act; Interim Procedural Rules for Exemptions
From the Polychlorinated Biphenyl (PCB) Processing and Distribution
in Commerce Prohibitions)
Preamble, page 31558
"Unless EPA grants exemptions, all PCB processing and distri-
bution in commerce will be banned after July l, 1979 pursuant to
section 6(e)(3)(A)(ii) of TSCA. These activities include, but are
not necessarily limited to: the processing and distribution in
commerce of dielectric fluid for PCB Transformers, PCB-Contaminated
Transformers, PCB Railroad Transformers, and PCB Electromagnets;
the distribution in commerce of PCB Articles (such as small PCB
Capacitors); the processing (i.e., building) and distribution in
commerce of PCB Equipment (including the manufacture of fluorescent
light ballasts, television sets, air conditioners and microwave
ovens and the sale of such PCB Equipment) ; the processing and
distribution in commerce of PCBs for servicing mining equipment;
the processing and distribution in commerce of chemical substances
and mixtures that contain 50 ppm or greater PCB as impurities or
contaminants (including diarylide and phthalocyanine pigments, some
aluminum chloride, and some phenylchlorosilanes)."
Preamble, page 31559
"Petitions concerning the manufacture (i.e., processing) of
PCB Equipment involving incorporation of PCB Articles into equip-
ment must be submitted on an individual basis. Although this
activity in itself may present a low potential risk, the activity
results in the wide dissemination of small PCB Capacitors. The
disposal of such capacitors is not controlled once the capacitors
are processed into PCB Equipment. Since most PCB Equipment manu-
facturers have converted to non-PCB Capacitors, the number of
potential petitioners for exemptions to manufacture PCB Equipment
should be small."
Codified (40 CFR 750.31fan. Page 31560
"(7) Processing of PCB Articles into FOB Equipment. A person
who processes (incorporates) PCB Articles (such as small PCB
Capacitors) into PCB Equipment may submit a petition on behalf of
himself and all persons who further process or distribute in
commerce PCB Equipment built by the petitioner. For example, a
builder of motors who places small PCB Capacitors in the motors may
submit a petition on behalf of all persons who process or
incorporate motors built by the petitioner into other pieces of PCB
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Equipment: and all those who sell the equipment. Such a petition is
not required to identify the persons who distribute in commerce or
further process the PCB Equipment. A separate petition must be
filed, however, by each processor of PCB Articles into PCB
Equipment."
"(8) Processing of PCB Equipment into Other PCB Equipment. A
person who processes (incorporates) PCB Equipment into other PCB
Equipment may submit a petition on behalf of himself and all
persons who further process or distribute in commerce PCB Equipment
built by the petitioner. Such a petition is not required to
identify the persons who distribute in commerce or further process
the PCB Equipment. If a petition has been filed under subparagraph
(a) (7) by the builder of the original PCB Equipment, no other
petition is required."
FR September 26. 1988 - Proposed Rule (40 CFR Part 761)
(Polychlorinated Biphenyls; Notification and Manifesting for PCB
Waste Activities)
Preamble, page 37438
"... PCB waste may also be * generated1 by those who ...
process or distribute in commerce PCB wastes in a form other than
previously manifested, ..."
FR December 21. 1989 - Final Rule (40 CFR Part 761)
(Polychlorinated Biphenyls; Notification and Manifesting for PCB
Waste Activities)
Preamble, page 52717
"... an owner of the PCB material would be the generator when
the owner:
"... (3) Causes PCB-containing treatment residuals to be
generated on-site during servicing or processing for disposal
operations conducted on-site by the owner or by a contractor."
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WORDING FROM THE CODE OF FEDERAL REGULATIONS
40 CFR PART 750
750.31 (Filing of petitions for exemption.)
11 (a)(2) Contaminated substances and mixtures — processing.
. . . For example, persons who process a PCB-contaminated pigment
into printing inks may combine their petitions into one petition.
it
• • •
[(a)(7) and (a)(8) are the same as above]
40 CFR PART 761
761.3 (Definitions)
"xProcess1 means the preparation of a chemical substance or
mixture, after its manufacture, for distribution in commerce:
(1) In the same form or physical state as, or in a different
form or physical state from, that in which it was received by the
person so preparing such substance or mixture, or
(2) As part of an article containing the chemical substance
or mixture."
11 xRecycled PCBs1 means all those PCBs which appear in the
processing of paper products or asphalt roofing materials from PCB-
contaminated raw materials. Processes which recycle PCBs must meet
the following requirements:" [the requirements are effluent
limitations].
761 .--20 (Prohibitions)
(c)(2) "PCBs at concentrations of 50 ppm or greater, or PCB
Items with PCB concentrations of 50 ppm or greater may be processed
and distributed in commerce in compliance with the requirements of
this Part for purposes of disposal in accordance with the
requirements of § 761.60."
(c) (4) "PCBs at concentrations of less than 50 ppm, or PCB
Items, with PCB concentrations of less than 50 ppm, may be
processed and distributed in commerce for purposes of disposal."
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761.30 (Authorizations)
GENERAL — Processing and distribution in commerce for
purposes of servicing PCB electrical equipment, research and
development, and use as a mounting medium in microscopy is
permitted only for persons that are granted an exemption under TSCA
6(e)(3)(B).
761.60 (Disposal requirements)
"NOTE: Except as provided in § 761.75(b) (8) (id.).,., liquid PCBs
shall not be processed into non-liquid forms to circumvent the high
temperature incineration requirements of § 761.60(a)7"
761.185 (Certification program and retention of records by
importers and persons generating PCBs in excluded manufacturing
processes)
"(a) ... manufacturers with processes inadvertently generating
PCBs and importers of products containing inadvertently generated
PCBs must report to EPA ... "
WORDING FROM SUPPORT DOCUMENTS
PCB Q & A
11 ... Also, PCBs at any concentration may be processed (i.e.,
prepared and/or packaged for distribution in commerce) for purposes
of disposal [§761.20(c) (2)]."
TSCA COMPLIANCE PROGRAM POLICY No. 6-PCB-2
"EPA reviewed its interpretation of the PCB regulations
regarding physical separation and found that the original PCB rules
clearly do not exempt PCB processing activities (including physical
separation techniques) from the disposal requirements. While
activities which process or distribute in commerce PCBs for
purposes of disposal are not subject to processing and distribution
in commerce bans, such activities are subject to disposal
regulations."
"... Filtering PCBs from the dielectric fluid of transformers
and returning that fluid to the transformer is an example of this
type of activity. Because the processed liquids and solids are
returned or reused in regulated equipment, EPA controls the
ultimate disposition of all the processed materials and no disposal
requirements are circumvented."
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"CHLOROFLUOROCARBONS"
FINAL RULE [43 Fed. Reg. 11318, (17 March 1978)]
"... The economic effects will be felt by three major
groups in the chlorofluorocarbon industry: manufacturers,
processors (fillers), and distributors (marketers). . .
. Fillers, on the other hand, will be significantly
affected ..."
"Proposed § 762.12 did not prohibit processing of
chlorofluorocarbon propellants for use in pesticide
products. EPA requested comments on whether TSCA section
3(2) (B) (ii) permits EPA to regulate under TSCA the pro-
cessing of chlorofluorocarbons which may take place as
part of the manufacture of pesticide products (42 FR
24545). No comments on this point were received. Having
considered the issue further, both in connection with
this regulation and the TSCA section 8 (a) inventory
reporting regulation, EPA has concluded that there is
sufficient authority under TSCA to ban the processing of
chlorofluorocarbons for use in pesticides (i.e., incor-
poration of chlorofluorocarbons into aerosol pesticides) .
* • •
"The change in § 762.12 does not significantly alter the
practical impact of this regulation because a ban on
manufacturing for pesticide uses was previously proposed
(§ 762.11). It will, however, greatly aid the Agency in
its enforcement efforts since the enforcement emphasis
will be on processors."
"The definitions for . . . 'processor1 . . . have been
deleted from the rule. These words have the exact
definitions given to them in TSCA (15 U.S.C. 2602), and
there is no need to repeat the definition in the rule.
"The definitions for 'manufacture,' 'processing,'
•distribute in commerce, ' and 'distribution in commerce'
have also been omitted. The deletions of the special
provisions relating to exports which were included in the
proposed rule now make these definitions identical to the
ones appearing in TSCA."
OTHER DOCUMENTS
EPA Enforcement Facts and Strategy; Chlorofluorocarbons
(CFCs). 15 November 1979 [released by Pesticides and Toxic
Substances Enforcement Division]:
"Any manufacturer, bulk distributor, bulk importer, or
processor (filler) of chlorofluorocarbons is subject to
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the rule, as are importers and exporters of aerosol
products."
"There are five CFC manufacturers and approximately 800
aerosol fillers in the United States. . ."
"Enforcement efforts will focus on accounting for CFCs
purchased by fillers. The Agency will try to make sure
that all CFCs purchased for aerosol propellant uses are
being employed in exempt products, and that the exemp-
tions given are not being abused.
• •-,/„.
"Inspections will be limited to those fillers currently
buying CFCs. Violations by manufacturers and
distributors can only occur if there are associated
filling (processing) violations. . ."
"There are approximately 800 aerosol fillers. ('Filler1
is the term used in the trade; 'processors' is the term
used in the rule and in TSCA.) About one quarter of them
have purchased CFCs since the ban or have provided manu-
facturers with a certification. About half of all
fillers are custom fillers, i.e., they fill for others
under contract. Many fillers are small businesses."
"Every person who processes fully halogenated chloro-
fluoroalkanes for aerosol propellant uses subject to TSCA
after December 15, 1978 must submit an annual report. A
separate report must be submitted for each processing
facility."
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"ASBESTOS" (BAN AND PHASE-OUT RULE)
FINAL RULE [54 Fed.Reg. 29460, 29463 (12 July 1989)]
"The rule's distribution in commerce ban does not cover all
actions taken with respect to asbestos-containing products. For
purposes of the rule, the term 'distribution in commerce1 does not
cover end use activities, for example, sale, resale, holding, or
delivery, with respect to asbestos products by persons who use the
product after it is manufactured, imported, or processed. For
example, the term 'distribution in commerce' does not include the
resale of homes or motor vehicles that contain asbestos-containing
parts or products or the installation of asbestos-containing brake
pads in a person's automobile after the distribution in commerce of
such brake pads is banned. (However, it is a violation of this
rule for a person to engage in selling brake pads to anyone.) This
provision also does not cover the disposal of asbestos-containing
products." ...
"For example, this rule's bans do not cover the manufacture,
importation, processing and distribution in commerce of high-grade
electrical paper, a product which may be similar in some cases to
millboard or other asbestos paper products. Persons might try to
manufacture or distribute the excluded products for uses that are
banned. Such activities would violate this rule's bans because
this conversion of use will be interpreted by EPA to be processing
or distribution in commerce of the banned products. The defini-
tions of processing and distribution in commerce are broad and will
be interpreted by EPA to cover activities which involve the con-
version of excluded asbestos-containing products in this manner."
fNOTE; Elsewhere in the final Asbestos "Ban and Phase-Out Rule,"
processing is defined simply by reference to the TSCA Section 3
language, and no further examples are given.]
EPA CORRESPONDENCE
Letter from John W. Melone to David M. Wassum of the Institute of
Scrap Recycling Industries, Inc., 23 February 1990:
"This is in response to your letter of September 21, 1989
to John Rigby. In that letter, you requested confirmation
that the impending bans on processing and distribution in
commerce of designated asbestos-containing products do
not apply to the collection, transfer, and processing of
obsolete products for recycling.
"You state that members of the Institute of Scrap
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Recycling Industries, Inc. (ISRI) process, prepare, and
recycle various materials, such as ferrous and nonferrous
metallic scrap, paper, glass, and plastics. They pre-
dominantly handle metallic scrap in its various forms.
Major sources of metallic scrap include obsolete consumer
products such as automobiles and household appliances, as
well as industrial and commercial machinery and
equipment. Some of these items may contain asbestos.
The scrap is baled, shredded, or sheared.
"We conclude that the recycling of asbestos-containing
material, as described in the letter, is not covered by
the asbestos ban and phaseout rule (40 C.F.R. 763.160-
.179). While the recycling of asbestos-containing
products to recover metals or other materials is con-
sidered processing, the products that result from that
processing are scrap metal (or a similar scrap paper or
plastic products) which will be available for reuse after
further smelting or other processing and waste materials,
such as "fluff", which will be disposed of. Scrap metal
(or another scrap product) is not included within the
ban. Thus, even though recycling is considered pro-
cessing, the product being processed is not a banned
product.
"Further, the movement of a product subject to the rule
(e.g. asbestos brakes or asbestos gaskets in an obsolete
motor vehicle) to a recycling facility at any time would
not violate the distribution in commerce ban. The
definition of distribution in commerce in the rule 'does
not include actions taken with respect to an asbestos-
containing product (to sell, resell, deliver, or hold) in
connection with the end use of the product by persons who
are users (persons who use the product for its intended
purpose after it is manufactured or processed).' Since
recycling is not prohibited, the movement in commerce to
recycling facilities would not be considered a violation
of the distribution in commerce ban. Generally, the rule
limits the introduction of new asbestos products into the
chain of commerce, rather than reducing exposure from
products already in commerce.
"Note, if a person makes a product from scrap metal (or
other scrap material) that results from recycling and
that product meets the criteria of 'asbestos-containing
product' as defined in the rule (i.e., contains more than
one percent asbestos by weight or area, or contains any
intentionally added asbestos), and is in a product
category banned under the rule, then that product would
be subject to the asbestos ban and phaseout provisions."
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Letter from John W. Melone to Marc L. Fleischeker of Arent, Fox, 15
March 1990:
"The rule prohibits the importation into the United
States of asbestos beater-add and sheet gaskets (except
specialty industrial gaskets) for installation into
export-bound engines or vehicles. While the rule does
not prohibit the importation of 'products imported solely
for shipment outside the customs territory of the United
States, unless repackaging or processing of the product
is performed in the United States,' the installation of
imported gaskets in engines for export constitutes both
'repackaging1 and 'processing'."
Letter from John W. Melone to Alex R. Cunningham of the State of
California Department of Health Services, 29 March 1990:
"EPA believes that processing for commercial purposes
asbestos-containing material by vitrification, or other
transformation processes, is 'new' withing the meaning of
the rule.
"The rule does not regulate disposal activities.
Although the actions taken under this rule are based on
lifecycle risks of asbestos products, the risk associated
with various disposal methods was not addressed under
this rule. With respect to the rule's distribution in
commerce ban, the preamble states that this provision
does not cover the disposal of asbestos-containing
products. Under section 763.163, Definitions.
•Distribution in Commerce1 does not include distribution
by manufacturers, importers, and processors, and other
persons solely for purposes of disposal of an asbestos-
containing product.
"Operations that transform asbestos-containing materials,
as defined in 40 CFR 61.141, into nonasbestos material
solely for disposal, (as an alternative disposal method
under the asbestos NESHAP regulations), would be subject
to the disposal requirements at 40 CFR 61.151 or 61.152,
or any final standards revising the asbestos NESHAP under
40 CFR, part 61.155."
Letter from John W. Melone to Lawrence G. Wylie of Omega Phase
Transformations, Inc., 30 March 1990:
"This responds to your request for clarification of the
final Asbestos Ban and Phaseout Rule as it applies to
vitrification processes which transform asbestos into
asbestos-free material. You asked for an affirmation
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that the Asbestos Ban and Phaseout Rule is inapplicable
to your asbestos vitrification and detoxification
process. For the reasons discussed below, the Agency
disagrees with your conclusion.
"EPA is not aware of any firm that processed and sold
glass made from asbestos-containing waste material before
August 26, 1989. EPA therefore considers 'processing for
commercial purposes' asbestos-containing material by
vitrification as 'new' within the meaning of the rule.
"The rule is not intended to cover asbestos disposal
activities. While 'processing for disposal' is not
addressed under section 763.167, Processing Prohibitions,
the rule specifically excludes disposal from prohibitions
against 'distribution in commerce1. Under the definition
of 'Distribute in Commerce1 (section 763.163), the rule
states that the term does not include distribution by
manufacturers, importers, and processors, or other
persons solely for purposes of disposal of an asbestos-
containing product. Furthermore, the Agency did not
address 'processing for disposal1 in the preamble to the
rule, nor in other analyses supporting the rule.
"Operations that transform asbestos into non-asbestos
material solely for disposal, as an alternative to NESHAP
regulations for traditional land dispersal, would be
subject to any final standards adopted in connection with
the proposed revision to the asbestos NESHAP under 40
CFR, part 61.155."
Letter from John W. Melone to Steve Suber of EIS Brake Parts, 25
April 1990:
"The rebuilder must dispose of old asbestos-containing
brake shoes returned for rebuilding. Disassembly, or
relining (including replacement , with non-asbestos
material), of asbestos brakes is 'processing' within the
meaning of the term under the Toxic Substance Control Act
(TSCA). The term, 'process' means the preparation of a
chemical substance or mixture, after its manufacture, for
distribution in commerce, (a) in the same form or physi-
cal state as, or in a different form or physical state
from, that in which it was received by the person so
preparing such substance or mixture, or (b) as part of an
article containing the chemical substance or mixture (See
TSCA section 3, Definitions.) Under the Asbestos Ban and
Phaseout Rule, 'processing' will be prohibited as of the
effective dates of the 'processing bans' noted above."
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Letter from John W. Melone to R. Scott Lang of Spilman, Thomas,
Battle & Klostermeyer, 23 May 1990:
"Asbestos-containing wire and cable is not addressed by
the Asbestos Ban and Phaseout Rule (ABPO), and conse-
quently, its manufacture and processing is not restricted
per se by the Rule. However, the processing of certain
materials into wire and cable will be banned."
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57 ("IMMINENT HAZARDS.")
TSCA (THE ACT)
According to §7 (a) of TSCA, the EPA Administrator may commence
a civil action . . . "(B) for relief . . . against any person who
. . . processes ... an imminently hazardous chemical substance or
mixture or any article containing such a substance or mixture . .
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SB ("REPORTING AND RETENTION OF INFORMATION."!
S8fa) ("REPORTS.")
TSCA (THE ACT)
According to TSCA §8(a)(l), the Administrator "shall promulgate
rules under which - (A) each person (other than a small . . .
processor) who . . . processes or proposes ... to process a
chemical substance (other than a chemical substance described in
subparagraph (B)(ii) shall maintain such records and shall submit
to the Administrator such reports, as the Administrator may
reasonably require, and (B) each person (other than a small . . .
processor) who . . . processes or proposes ... to process (i) a
mixture, or (ii) a chemical substance in small quantities (as
defined by the Administrator by rule) solely for the purposes of
scientific experimentation or analysis or chemical research on, or
analysis of, such substance or another substance, including any
such research or analysis for the development of a product, shall
maintain records and submit to the Administrator reports but only
to the extent that the Administrator determines the maintenance of
records or submission of reports, or both, is necessary for the
effective enforcement of this Act. The Administrator may not
require in a rule promulgated under this paragraph the maintenance
of records or the submission of reports with respect to changes in
the proportions of the components of a mixture unless the Adminis-
trator finds that maintenance of such records or the submission if
such reports, or both, is necessary for the effective enforcement
of this Act "
According to §8(a)(2) of TSCA, "the Administrator may require
under paragraph (1) maintenance of records and reporting with
respect to the following insofar as known by the person making the
report or insofar as [is] reasonably ascertainable: . . .
"(C) The total amount of each such substance .
processed, reasonable estimates of the total amount to be
. . . processed, the amount . . . processed for each of
its categories of use, and reasonable estimates of the
amount to be•. . . processed for each of its categories
of use or proposed categories of use.
"(D) A description of the byproducts resulting from the
. . . processing ... of each such substance or mixture.
TSCA §8(a) (3) (A) (i) states that "The Administrator may by rule
require a small . . . processor of a chemical substance to submit
to the Administrator such information respecting the chemical
substance as the Administrator may require for publication of the
first list of chemical substances required by subsection (b)
[(i.e., the initial TSCA Chemical Substances Inventory)]."
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TSCA §8(a)(3)(A)(ii) states that "The Administrator may by
rule require a small . . . processor of a chemical substance or
mixture . . . [subject to proposed and/or final rules promulgated
under certain sections of TSCA or for which injunctive relief has
been granted by civil action under sections 5 or 7 of TSCA] to
maintain such records on such substances or mixture, and to submit
to the Administrator such reports on such substance or mixture, as
the Administrator may reasonably require "
According to §8(a)(3)(B) of TSCA, "The [EPA] Administrator,
after consultation with the Administrator of the Small Business
Administration [(SBA)] shall by rule prescribe the standards for
determining the . . . processors which qualify as Ismail . . .
processors for the purposes of this paragraph and paragraph (1)."
QUESTION AND ANSWER DOCUMENTS
A July 25, 1986 "Question and Answer Summary" prepared by EPA
following a June 10, 1986 Agency-sponsored seminar on the industry
obligations under TSCA presents the following with regard to the
term processor under §8(a) of TSCA:
"Question: Are processors covered by section 8(a)?
"ANSWER: Yes. Section 8(a) authorizes EPA to require
reporting and recordkeeping by chemical manufacturers,
importers, and/or processors. EPA establishes these
requirements for specific chemical substances by means of
specific regulatory actions (generally referred to as
•rules'). Thus, processors are only subject to the
requirements of a section 8(a) regulation if that rule
expressly requires processors to report data and/or keep
records.
"Question; Is there a small business exemption for. . .
processors of regulated chemicals under section 8(a)?
"Answer; Generally, yes. Section 8(a) exempts small .
. . processors from the requirements of section 8 (a)
rules (with certain limited statutory exceptions). Note
that TSCA authorizes EPA to establish the standards for
defining small businesses for purposes of this section
8(a) exemption; the Agency must do so by rule
"The Agency has defined 'small processor' on a rule-by-
rule basis and intends to continue to do so for the
foreseeable future. All . . . processors subject to
section 8 (a) rules should check the small business
exemption standards in those rules to determine and/or
verify their exemption status."
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"CHEMICAL-SPECIFIC RULES"
CODE OF FEDERAL REGULATIONS (CFR)
Part 704 - Reporting and Recordkeeping Requirements
Subpart A - Section 8(a) Information-Gathering Rules
According to 40 CFR §704.3, the term "Article" is defined as
"a manufactured item (1) which is formed to a specific shape or
design during manufacture, (2) which has end use function(s)
dependent in whole or in part upon its shape or design during end
use, and (3) which has either no change of chemical composition
during its end use or only those changes of composition which have
no commercial purpose separate from that of the article, and that
result from a chemical reaction that occurs upon end use of other
chemical substances, mixtures, or articles; except that fluids and
particles are not considered articles regardless of shape or
design."
40 CFR §704.3 defines the term "Process" to mean "to process
for commercial purposes."
The term "to process for commercial purposes" is defined in 40
CFR §704.3 to mean "the preparation of a chemical substance or
mixture after its manufacture for distribution in commerce with the
purpose of obtaining an immediate or eventual commercial advantage
for the processor. Processing of any amount of a chemical sub-
stance or mixture is included in this definition. If a chemical
substance or mixture containing impurities is processed for com-
mercial purposes, then the impurities also are processed for
commercial purposes."
40 CFR §704.3 also defines the term "Processor" to mean "any
person who processes a chemical substance or mixture."
Part 704 — Reporting and Recordkeeping Recruirments
Subpart B - Chemical Specific Reporting/Recordkeepinq Rules
HEXACHLORONORBORNADIENE (HEX-BCH)
According to §704.102(a) ("Definitions."), a "Small business"
means "any manufacturer, importer, or processor who meets either
paragraph (a)(4)(i) or (ii) of this section:
11 (i) A business is small if its total annual sales, when
combined with those of its parent (if any) , are less than
$40 million. However, if the annual manufacture, importa-
tion, or processing volume of a particular chemical
substance at any individual site owned or controlled by
the business is greater than 45,400 kilograms (1OO,OOO
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pounds), the business shall not qualify as small for
purposes of reporting on the manufacture, importation, or
processing of that chemical substance at that site,
unless the business qualifies as small under paragraph
(a)(4)(ii) of this section.
"(ii) A business is small if its total annual sales, when
combined with those of its parent company (if any), are
less than $4 million, regardless of the quantity of the
particular chemical substance manufactured, imported, or
processed by that business.
(iii) For imported and processed mixtures containing
HEX-BCH, the 45,400 kilograms (100,000 pounds) standard
in paragraph (a) (4)(i) of this section applies only to
the amount of HEX-BCH in a mixture and not the other
components of the mixture.
According to 40 CFR §704.102(b) ("Persons who must report."),
"Reports must be submitted by (1) :
11 (i) Persons who are manufacturing, importing, or pro-
cessing HEX-BCH for use as an intermediate in the pro-
duction or isodrin or endrin on or after January 2, 1986;
and
"(ii) Persons who propose to manufacture, import, or pro-
cess HEX-BCH for use as an intermediate in the production
of isodrin or endrin, on or after January 2, 1986."
According to 40 CFR §704.102 (b) (2) , reports must also be
submitted by "Persons described in paragraph (b)(1) of this section
who engage or propose to engage in more than one ac€l'vity (i.e.,
manufacture and processing) must report the information required in
paragraph (d) separately for each activity."
40 CFR §704.102(c) states that the following persons are
exempt from reporting "(1). Small businesses." and "(2) Persons
described in § 704.5(a) and (c)."
HEXAFLUOROPROPYLENE OXIDE (HFPO)
According to 40 CFR §704.104(a) ("Definitions."), an "Enclosed
process" is "a process that is designed and operated so that there
is no intentional release of any substance present in the process.
A process with fugitive, inadvertent, or emergency pressure relief
releases remains an enclosed process so long as measures are taken
to prevent worker exposure to and environmental contamination from
the releases."
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40 CFR §704.104(a) defines the term "Small processor" to mean
a processor that meets either the standard in paragraph (a)(3)(i)
of this section or the standard in paragraph (a) (3) (ii) of this
section.
"(i) First standard. A processor of a chemical substance
is small if its total annual sales, when combined with
those of its parent company, if any, are less than $40
million. However, if the annual processing volume of a
particular chemical substance at any individual site
owned or controlled by the processor is greater than
45,400 kilograms (100,000 pounds), the processor shall
not qualify as small for purposes of reporting on the
processing of that chemical substance at that site,
unless the processor qualifies as small under paragraph
(a)(3)(ii) of this section.
"(ii) Second standard. A processor of a chemical
substance is small if its total annual sales, when
combined with those of its parent company (if any), are
less than $4 million, regardless of the quantity of the
particular chemical substance processed by that company.
"(iii) Inflation index. EPA will use the Inflation Index
described in the definition of 'small manufacturer1 that
is set forth in § 704.3 for purposes of adjusting the
total annual sales values of this small processor defini-
tion. EPA will provide FEDERAL REGISTER notification
when changing the total annual sales values of this
definition."
According to 40 CFR §704.104(b) ("Persons who must report.)/
"Except as provided in paragraph (c) of this section, the following
persons are subject to this section:
"(3) Persons who process or propose to process HFPO
as an intermediate in the manufacture of
fluorinated substances in an enclosed
process."
40 CFR §704.104(c) ("Persons not subject to this rule.")
states that the following persons are not subject to this rule:
"(1) Small processors.
"(2) Persons described in § 704.5 (a) through (d).
"(3) Persons who have already submitted to EPA a
completed copy of the Preliminary Assessment
Information Manufacturer's Report (EPA Form
7710-35, as described at § 712.28 of this
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chapter) for HFPO, as required by § 712.30(d)
of this chapter are not required to report
under this section with respect to activities
previously reported on."
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"CAIR"
Part 704 — Reporting and Recordkeeping Requirements
Subpart C - CAIR: Comprehensive Assessment Information Rule
According to 40 CFR 204.203, "all definitions as set forth in
section 3 of TSCA and §704.3 [(Subpart A - Definitions)] apply" to
Subpart C. Also, 40 CFR 204.3 provides definitions for a number of
additional process-related terms as follows.
According to 40 CFR §704.203, the term "Processing activities"
means "all those activities which include (1) preparation of a
substance identified in Subpart D of this Part after its manufac-
ture to make another substance for sale or use, (2) repackaging of
the identified substance, or (3) purchasing and preparing the
identified substance for use or distribution in commerce."
40 CFR §704.203 defines a "Repackager" to be "a person who
buys a substance identified in Subpart D of this Part or mixture,
removes the substance or mixture from the container in which it was
bought, and transfers this substance, as is, to another container
for sale."
Finally, 40 CFR §704.203 states that a "Small processor" means
"a processor that meets either of the following standards:
"(1) First Standard. A processor of a substance is small
if its total annual sales, when combined with those of
its parent company (if any), are less than $40 million.
However, if the annual processing volume of a particular
substance at any individual site owned or controlled by
the processor is greater than 45,000 kilograms (100,000
pounds), the processor shall not qualify as small for
purposes of reporting on that substance at that site,
unless the processor qualifies as small under standard
(2) of this definition.
"(2) Second Standard. A processor of a substance is small
if its total annual sales, when combined with those of
its parent company (if any) , are less than $4 million,
regardless of the quantity of substances processed by
that processor."
FINAL RULES
CAIR FINAL RULE PREAMBLE (53 FR 51698; December 22. 1988)
The preamble to the final TSCA §8(a) CAIR rule states that ".
. . under the CAIR, all of the steps involved in making a CAIR
listed substance, including adding stabilizers and additives, which
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are necessary to get the substance "out the door" or ready for use,
are considered part of manufacturing."
CAIR FORM INSTRUCTIONS - PART 5; GLOSSARY
Part 5 ("Glossary) of the publicly available TSCA §8(a) "CAIR
FORM" provides the following process-related definitions:
"Article producer; A processor who processes the listed
substance with another substance to form an article for
subsequent distribution in commerce or for use on-site.
The listed substance may or may not be chemically altered
or consumed in this process. For example, Company A buys
chemical Y, a plastic additive, and mixes it with: molten
plastic to form plastic parts."*
"Chemical producer: A processor who processes the listed
subatance as a raw material or as an intermediate in the
manufacture of other substances for subsequent distribu-
tion in commerce or for use on-site. The listed substance
is chemically altered or otherwise consumed during this
operation. For example, Company a buys Chemical X, which
is reacted with Chemical Y to manufacture Chemical Z."
"Commercial distribution or Distribution in commerce;
The sale of the listed substance, mixture or article in
commerce; the introduction or delivery of the listed
substance, mixture, or article into commerce; or the
holding of the listed substance, mixture, or article
after its introduction into commerce. This term includes
test marketing the listed substance."
"End users; An individual or organization that uses or
consumes a chemical substance, mixture, or article with
no further intentions of manufacturing or processing the
substance, mixture, or article. Includes consumers and
commercial, industrial and retail users."
"Mixture producer; A processor who processes the listed
substance with another substance or mixture to produce a
mixture for subsequent distribution in commerce or for
use on-site. The listed substance or mixture is not con-
sumed or chemically altered during this operation. For
example, Company A buys Chemical X, which is a pigment,
and adds this to a paint base to color the paint."
"Process: To process for commercial purposes."
"Process for commercial purposes; The preparation of a
chemical substance or mixture after its manufacture for
distribution in commerce with the purpose of obtaining an
immediate or eventual commercial advantage for the
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processor. Processing of any amount of a chemical
substance or mixture is included in this definition. If
a chemical substance or mixture containing impurities is
processed for commercial purposes, then the impurities
are also processed for commercial purposes."
"Processor: Any person who processes a chemical substance
or mixture."
QUESTION AND ANSWER DOCUMENTS
Comprehensive Assessment Information Rule
QUESTION AND ANSWER DOCUMENT
December, 1988
Q16. I am confused as to how to report concerning my manufacturing
and processing activities. If I both manufacture and process
a CAIR listed substance at the same plant site, how do I
determine when my manufacturing process type ends, and my
processing process type begins?
A16. EPA has developed some general guidelines to assist
respondents in this determination. It is important to examine
all manufacturing and processing activities together to
determine how these activities should be reported^ However>~
each plant site must report for its activities oiigje::separate
CAIR form. Note that unit operations need not be in the same
vicinity of the plant site to be considered part of the same
process type. For all of the guidelines given below, assume
"X" is the CAIR listed substance.
Manufacturing:
(1) Manufacture of a CAIR listed substance from raw
materials:
Raw
Materials
X
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(2)
Purification of a CAIR listed substances:
X10% or Raw
Material X/Y
i
or
Y
If both "X" and "Y" are CAIR listed substances, respondent
must list the process type twice, once for each CAIR listed
substance, on separate reporting forms.
A person would include as part of his manufacturing process
type all steps that lead up to the production of a final
product for distribution in commerce. This includes those
steps that might be considered processing steps if such steps
are necessary "to make [the final product] ready for sale or
use." For example, a CAIR listed substance may not be ready
for sale or use until the required additives or stabilizers
have been added, or the final product has been loaded or
packaged into salable containers.
Processing:
(1) Addition of additives or stabilizers to a CAIR listed
substance:
X/additives or stabilizers
(2)
Processing a CAIR listed substance to manufacture a
new substance (article or chemical producer):
X
Y (which contains no X)
If both "X" and "Y" are CAIR listed substances, the respondent
must report as both a processor of "X" and as a manufacturer
of "Y."
(3) Processing a CAIR listed substance to manufacture a
mixture (mixture producer):
X
Y
Mixture X/Y
A person who dilutes a CAIR listed substance with a solvent is
also classified as a mixture producer.
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The following steps are a guide to determine whether a person
is a manufacturer or a processor:
(1) Do you purchase raw materials and manufacture final
products that contain a CAIR listed substance?
o If yes, you are a manufacturer of all final products
that are produced using that process type.
o If no, go to (2).
(2) Do you import a CAIR listed substance from outside the
territorial United States?
o If yes, you are a manufacturer of both the imported
CAIR listed substance and all final products that are
produced using the imported CAIR listed substance as a
raw material.
o If no, go to (3) .
(3) Do you purchase a CAIR listed substance from a domestic
supplier and purify the CAIR listed substance to a higher
grade of purity?
o If yes, you are a manufacturer of the higher purity
grade CAIR listed substance, and all final products that
are produced using the higher purity grade CAIR listed
substance.
o If no, go to (4).
(4) Do you purchase a raw material that contains a CAIR listed
substance from a domestic supplier and "purify" the CAIR
listed substance by separating out the CAIR listed substance
from the raw material?
o If yes, you are a manufacturer of the CAIR listed
substance that was separated out from the raw material,
and all final products that are produced using the
separated out CAIR listed substance.
o If no, go to (5).
(5) If you purchase a CAIR listed substance from a domestic
supplier, do not fall within any of the above guidelines, and
use the CAIR listed substance in a process type (i.e., not as
an end user);
o You are a processor of the CAIR listed substance.
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(6) If you have a process type that does not fit within any of
the guidelines set forth above, contact the TSCA Assistance
Office at (202) 554-1404 for further assistance.
Q17. We buy chemical X (a CAIR listed substance) as a raw material
from a supplier at 80% purity. We purify this raw material to
make 90% pure Chemical X, and then sell it to our customers.
Since we do not actually "manufacture" any more Chemical X
than we buy, must we report as a manufacturer of Chemical X?
A17. Yes. "Manufacture" of a substance includes, by definition,
the purification of that substance (40 CFR sec. 704.3).
Q18. Once we have produced a CAIR listed substance, we add
stabilizers to make the final product ready for shipment.
Does the addition of these stabilizers constitute processing
or manufacturing?
A18. If the company manufactures a CAIR listed substance from raw
materials and adds additives or stabilizers to aid in the
transportation of the final product, the addition of additives
or stabilizers contributes to making the final product ready
for sale or use. Therefore, this activity is considered
manufacturing, not processing. If, however, a company
purchases a CAIR listed substance from a domestic supplier and
adds additives or stabilizers to make a new final product for
a new end use, this would be considered processing.
Q19. In the process of manufacturing Chemical X, we manufacture a
small quantity of Chemical Y (a CAIR listed substance) . Prior
to selling Chemical X, we distill out Chemical Y and burn it
in our plant boiler to heat our plant. Do we have to report?
A19. Yes. In the process of manufacturing Chemical X, the company
has manufactured Chemical Y (a CAIR listed substance).
Because the company utilizes Chemical Y for a commercial
purpose (as a fuel in a boiler to generate heat or energy).
Q65. I manufacture a process stream which contains varying amounts
of X, Y and Z. As far as I know, the only commercially
feasible method for producing X, Y or Z is to fractionate the
stream I produce. If I sell, process or use the original
stream (Mixture X/Y/Z) as is, how do I report? If I
fractionate part of Mixture X/Y/Z into X, Y and Z, what is the
status of Mixture X/Y/Z under the CAIR?
A65. The process type described in the question can be diagrammed
as follows (assuming X is the CAIR listed substance):
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Raw
Materials
#1
Mixture
X/Y/Z
#2
X
Y
Z
Sale to Customers
The manufacturing process type in this example results in four
product types: Mixture X/Y/Z, X, Y, and Z. Unit operation #2
is part of the manufacturing process type because it results
in a final product ("X") which contains the CAIR listed
substance. Although Mixture X/Y/Z is an intermediate in the
manufacture of X, it is also a final product since it is
distributed in commerce to customers.
If the respondent manufactures only Mixture X/Y/Z (i.e., the
manufacturing process type does not include unit operation #2)
and uses (i.e., consumes) all of this manufactured mixture on
site, the respondent must still report under the CAIR, since
the use of Mixture X/Y/Z on site provides an "immediate
commercial advantage" to the respondent. Note that if both
"X" and "Y" are CAIR listed substances, respondent would
report the same process type for both final products, each on
its own form.
Assume that the respondent processes CAIR listed substance "X"
into Mixture X/Y/Z instead of manufacturing Mixture X/Y/Z from
raw materials (i.e., the respondent is a mixture producer).
If the respondent uses or consumes all of this processed
material on site, the respondent need not report under the
CAIR. This is because only those processors who process a
CAIR listed substance "for distribution in commerce" must
report under the CAIR.
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Comprehensive Assessment Information Rule
QUESTION AND ANSWER DOCUMENT
March, 1989
MANUFACTURING/PROCESSING SCENARIOS '
[Assume "Z" is the CAIR Listed Substance]
Following is a list of scenarios that describe whether a
person is a manufacturer or processor under the Comprehensive
Assessment Information Rule (CAIR).
Note first that there is a difference in the requirements that
a person must meet to be a "manufacturer" versus a "processor"
under the CAIR. To qualify as a manufacturer, a person must gain
a commercial benefit from the production of the CAIR listed
substance, but need not distribute the CAIR listed substance in
commerce. A processor, however, must distribute in commerce either
the CAIR listed substance or another substance produced using the
CAIR listed substance as a reactant (a chemical producer).
Therefore, if a company "uses" 100% of his processing capacity on-
site as a final product or as an end-use product, that person is
not a processor. "Use" of a CAIR listed substance as a reactant or
as a chemical intermediate to manufacture a completely different
substance which is distributed in commerce, however, is considered
processing of a CAIR listed substance (chemical producer).
1. Company A reacts X with Y to make Z. Z is sold.
o Company A must report as a manufacturer of Z.
2. Company A reacts X with Y to make Z. Z is used on site.
o Company A must report as a manufacturer of Z.
3. Company A reacts X with Y to make Z. Z is "sold" to another
plant site owned or operated by Company A.
o Company A must report as a manufacturer of Z. The
second plant site is the "customer" of the first plant
site.
'This Question and Answer document supplements the following
CAIR Question and Answer documents: December, 1988.
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4. Company A reacts X with Y to make Z. Company A sends the z to
Company B, who adds additives and stabilizers under a service
agreement with Company A. Company B returns 100% of the Z to
Company A, who distributes the Z in commerce.
o Company A must report as a manufacturer of Z.
o Company B is a service manufacturer of Z, even though
the addition of additives and stabilizers is technically
processing.
o As a service manufacturer of Z, Company B is not
required to report. Company A must report for both its
activities, as well as Company B's activities. Note that
for convenience, Company B may report on behalf of
Company A, but Company A is still liable for any errors
in reporting made by Company B.
o Rationale: Since Company A manufactures Z, Company B's
activities under a service agreement become an integral
part of Company A's manufacturing process type, and
therefore must be reported as such.
5. Same as Number 4, except Company B returns only part of the Z
to Company A, and distributes the remainder in commerce under
Company A's label.
o Company A must report as a manufacturer of Z.
o Company B is still a service manufacturer of Z, since
Company B's activities are still an integral part of
Company A's manufacturing process type. Distributing Z
in commerce under Company A's label is considered part of
the service agreement between Company A and Company B.
o As a service manufacturer of Z, Company B is not
required to report. Company A must report for both its
activities, as well as Company B's activities. Note that
for convenience, Company B may report on behalf of
Company A, but Company A is still liable for any errors
in reporting made by Company B.
6. Same as Number 4, except Company B returns only part of the Z
to Company A, and distributes the remainder in commerce under
its own (Company B's) label.
o Company A must report as a manufacturer of Z.
o Company B must report as a processor of the Z that is
distributed in commerce under its own label.
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o Company B is still a service manufacturer for the Z
that Company B processes under the service agreement with
Company A. This is because these activities are still an
integral part of Company A's manufacturing process type.
o Company B is not required to report on its activities
that fall under the service agreement with Company A.
Company A must report for both its activities, as well as
that portion of Company B's activities that fall under
the service agreement. Note that for convenience,
Company B may report on behalf of Company A for that
portion of Company B's activities that fall under the
service agreement, but Company A is still liable for any
errors in reporting made by Company B.
7. Same as Number 4, except Company B also purchases Z from
Company C; i.e., Company B adds additives and stabilizers to
the Z received from Company A under a service agreement, and
processes the Z it purchases from Company C. Company B
distributes only the Z it purchases from Company C in commerce
under its own (Company B's) label.
o Company A must report as a manufacturer of Z.
o Company B must report as a processor of the Z purchased
from Company C.
o Company B is still a service manufacturer for the Z
that Company B processes under the service agreement with
Company A. This is because these activities are still an
integral part of Company A's manufacturing process type.
o Company B is not required to report on its activities
that fall under the service agreement with Company A.
Company A must report for both its activities, as well as
that portion of Company B's activities that fall under
the service agreement. Note that for convenience,
Company B may report on behalf of Company A for that
portion of Company B's activities that fall under the
service agreement, but Company A is still liable for any
errors in reporting made by Company B.
8. Company A purchases Z only from Company C (Company C is a
manufacturer of Z) . Company C ships the Z directly to Company
B, who adds additives and stabilizers under a service
agreement with Company A. Company B sends the Z either to
Company A, who processes the Z, or directly to Company A's
customers under Company A's label.
o Company C must report as a manufacturer of Z.
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65
o Company B must report as a processor of Z. The service
agreement between Company B and Company A does not make
Company B a service manufacturer of Z in this instance,
since Company B's activities are not an integral part of
Company A's manufacturing process type. This is because
Company A does not manufacture Z.
o Company A must report only on its processing
activities. If Company B does not ship any Z to Company
A, Company A is not required to report.
9. Company A contracts with Company B to have Company B
manufacture Z for Company A. Company B does not distribute Z
to anyone except Company A under the contract. Company A
processes Z and distributes the final product in commerce.
o Company B must report as a manufacturer of Z (a toll
manufacturer), since Company B actually manufactures the
Z. This scenario differs from Number 4, where Company B
operates under a service agreement with Company A. As a
toll manufacturer of Z, Company B operates under a sales
contract to manufacture and sell Z to Company A.
o Company A must report only on its processing
activities.
10. Same as Number 9, except Company B sends only part of the Z it
manufactures to Company A. Company B also distributes Z in
commerce under its own (Company B's) label.
o Company B must report as a manufacturer of Z.
o Company A must report only on its processing
activities.
11. Company A reacts X with Y to make Z. Part of the Z is sold,
and part continues on in the process type. During the
continuation, additives are added to Z to make Zl. Z, is sold.
This process type is described by the following diagram:
Step #1 Step #2
X + Y > Z > Chemical Z, for #11
j (Chemical D for #12)
i
Sale to Customers
o Step i: Manufacturing.
o Step 2: Manufacturing, even though the addition of
additives is technically processing.
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o Rationale: Both Z and Zt are final products that
contain a CAIR listed substance (Z) , and are manufactured
using the same raw materials (X & Y) at the same site.
Step #2 is therefore a continuation, or extension, of
Step #1. This is an example of the manufacture of two
different "grades" of a final product containing the same
CAIR listed substance.
o Company A must report as a manufacturer of Z, and
include both Step #1 and Step #2 as part of its
manufacturing process type.
12. Same as Number 11, except the Z that is not sold is reacted
with Chemical W to make D. D does not contain Z (except as an
impurity). D is sold.
o Step 1: Manufacturing up to Step #2 (i.e., up to the
manufacture of Z).
o Step 2: Processing. Step #2 is not part of Company A's
manufacturing process type since D does not contain Z.
o Company A must report as a manufacturer of Z and as a
processor of Z (i.e., a manufacturer of D) on the same
CAIR reporting form.
13. Company A manufactures Z only as a waste and disposes it on
site.
o Company A is a manufacturer of a "byproduct," and is
therefore exempt from reporting.
14. Same as Number 13, except Company A sells the waste to another
company that uses the waste as a final product.
o Company A must report as a manufacturer of a
"coproduct" that contains Z.
15. Same as Number 13, except Company A burns the waste in a
boiler on site to generate heat for the plant.
o Company A must report as a manufacturer of a
"coproduct." Company A "uses" the waste for a commercial
purpose (and therefore obtains a commercial benefit) when
it burns the waste in its boiler to generate heat.
16. Company A purchases Z in a solution, and uses Z as a solvent
(or a catalyst) in the manufacture of Chemical D. D is
eventually extracted out and sold. Company A recycles the Z
and reuses it in the manufacture of D.
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o Company A is an end-user since Company A J'uses" Z as a
final product. Company A is therefore not required to
report.
17. Company A purchases Z and processes Z by mixing it with a
pigment to manufacture an ink, Mixture I,. I, is sold.
o Company A must report as a processor of Z (mixture
producer). Company A must report since the final product
(Ii) is distributed in commerce.
18. Same as Number 17, except that, once I, is produced, Company
A further processes. I, on site to print plastic bags which are
sold.
o Company A must report as a processor of Z (article
producer). This is because I, is distributed in commerce
as a component part of an article (the plastic bags).
o Note that if the Z is removed from It before the
printed plastic bags are distributed in commerce (e.g.,
Z vaporizes off when II is applied to the bags) , Company
A would be an end-user of Z, since neither Z nor a final
product produced utilizing Z as a reactant is distributed
in commerce.
19. Same as Number 18, but extended to Company A's customer,
Company B. Company B buys the plastic bags from Company A and
further processes the plastic bags before distributing them
further in commerce. Must Company B report as a processor of
Z?
o Company B purchases Z as part of an article (plastic
bags), and therefore is exempt from reporting.
20. Same as Number 17, except Company A buys It and processes I, on
site to print plastic bags which are sold. Company A buys I,
as either "I^" "Ink," or "Z."
o Company A must report as a processor of Z (article
producet). This is because II is distributed in commerce
as a component part of an article (the plastic bags).
o Note that if the Z is removed from It before the
printed plastic bags are distributed in commerce (e.g.,
Z vaporizes off when I, is applied to the bags) , Company
A would be an end-user of Z, since neither Z nor a final
product produced utilizing Z as a reactant is distributed
in commerce.
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21. Same as Number 20, except Company A uses the I1 it purchases
on site to print newsletters which are not sold.
o Company A is an end-user since Company A "uses" It as
a final product. Company A is therefore not required to
report.
22. Company A purchases Z and processes Z by reacting it with Y to
make Chemical D. D does not contain Z (except as an
impurity) . D is sold.
o Company A must report as a processor of Z (chemical
producer) . Company A must report since the final product
(D) is distributed in commerce.
23. Same as Number 22, except D is used 100% on site as a final
product (i.e., in an end-use capacity).
o Company A is not a processor of Z since D is not
distributed in commerce.
24. Company A purchases Z and processes Z by reacting it with Y to
make Chemical D. D does not contain Z (except as an
impurity) . D is not sold, but is processed on site by
reacting D with E to make Chemical F. F is sold. This
process type is described by the following diagram:
Step #1 Step #2
z + Y ---------- > D + E ---------- > F
o In those instances in which Company A can be classified
as both a chemical producer and some other type of
processor, that Company A must engage in a 2 -stage
analysis:
o Stage 1: Company A must first determine whether any
final product manufactured using Z as a-reactant is
distributed in commerce. If no, Company A is not
required to report. If yes, Company A must proceed to
stage 2 .
o Stage 2: Since a final product that was manufactured
using Z as a reactant is distributed in commerce, Company
A must report as a processor of Z. Company A would
report on the process type up to the point that Z no
longer exists.
o A CAIR listed substance no longer exists when it cannot
be identified by its CAS Number, or it exists in the
process stream or final product only as an impurity.
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o In this instance, Company A would only report as a
processor of Z through Step #1. If Z exists (other than
as an impurity) until D reacts with E to manufacture F,
Company A would report as a processor of Z through both
Step #1 and Step #2.
25. Same as Number 24, except that only a portion of the
manufactured D is processed on site. The other portion is
sold.
o Company A must still report as a processor of Z
(chemical producer).
o If Z ceases to exist during Step #1, Company A must
report as a processor of Z only through Step #1. If Z
exists (other than as an impurity) until D reacts with E
to manufacture F, Company A would report as a processor
of Z through both Step #1 and Step #2.
26. Company A uses a spray nozzle to paint cars which are
distributed in commerce. The spray nozzle "processes" two
streams to "manufacture" a paint, Chemical P,. One stream
contains Z and the other contains a pigment. These two
streams are processed by combining the two streams from two
separate hoses as they pass through the spray nozzle. The two
streams react on contact to create P,. P, does not contain Z.
o Because Company A is both a chemical producer and an
article producer, Company A must utilize the 2-stage
analysis set forth in Number 24.
o Stage 1: Company A must first determine whether any
final product manufactured using Z as a reactant is
distributed in commerce. In this instance, Company A
manufactures P,, which is distributed in commerce as a
component part of an article (the painted automobiles).
Therefore, Company A must proceed to stage 2 of the
analysis.
o Stage 2: Company A must report up to the point that Z
no longer exists. In this instance, Company A must
report as a processor of Z only up through the production
of Chemical P,. This is because Z does not exist in P,.
27. Company A operates a two-step process type. In Step #1,
Company A purchases Z and reacts Z with Y to make D. D
contains Z, but not as an impurity. Part of the D that is
manufactured is sold, and part continues onto Step #2, in
which the D is further processed into articles. This process
type is described by the following diagram:
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o Gasoline is a chemical substance under the TSCA
Inventory, and is not listed on the CAIR. Therefore,
Company A is not required to report under the CAIR.
A*******************************:
Comprehensive Assessment Information Rule
QUESTION AND ANSWER DOCUMENT
June, 1989
Q8. Company A purchases a CAIR listed substance, repackages it,
and distributes it in commerce. Before distributing the CAIR
listed substance in commerce, Company A samples the CAIR
listed substance to determine whether it meets Company A's
customer's required purity specifications. If not, the CAIR
listed substance is not distributed. Does Company A still
qualify as solely a repackager?
A8. Yes. Testing for purity is not classified as processing.
Therefore, Company A still qualifies as solely a repackager,
and is exempt from reporting under the CAIR.
Q22. What is the difference between the term "end-use" and the term
"consumed on-site?"
A22. The term "consumed on-site" is misleading and should never be
used. A person should focus on whether a CAIR listed
substance is used on-site in its end-use capacity (i.e., as an
end-use) . If it is not, that person is a processor. The term
"consumed on-site" was intended in the December. 1988 CAIR
Question and Answer document to mean "use on-site in its end-
use capacity." Some chemical processors incorrectly defined
the term "consumed on-site" to mean "use of a CAIR listed
substance as a raw material in a "processing" process type in
which the CAIR listed substance is totally reacted (i.e., as
a chemical producer)." This definition is incorrect.
"Chemical producers" are classified as processors, and are
therefore required to report under the CAIR.
Q24. Company A uses a CAIR listed substance to manufacture a
polyurethane foam that does not contain a CAIR listed
substance except as an impurity. Must Company A report as a
processor under the CAIR?
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A24. Yes. Company A is classified as a processor (chemical
producer).
Q25. Company A processes a CAIR listed substance to produce a final
product that does not contain the CAIR listed substance using
a 2-step "processing" process type. The process type consists
of two batch reactors operated in sequence. The CAIR listed
substance is completely reacted in the first reactor. Must
Company A report on both steps of the process type or just the
first step?
A25. Company A's "processing" process type can be diagramed as
follows:
Raw |_ Step
Materials ! # 1
No listed
substance
Step
# 2
Final
"Product
Since the CAIR listed substance is completely reacted during
Step #1, Company A is only required to report on Step #1
(i.e., up to the point that the CAIR listed substance ceases
to exist except as an impurity).
Q26. Company A purchases a CAIR listed substance and processes it
to manufacture polyurethane. In the process type, Company A
recaptures that portion of the CAIR listed substance that is
unreacted and sells it as a final product. How should Company
A report under the CAIR?
A26. Company A processes a CAIR listed substance in a single
process type to manufacture a final product (the polyurethane)
and a coproduct (the unreacted CAIR listed substance).
Company A should report for both of these final products on
the same reporting form.
Q27. Company A uses a CAIR listed substance as an initiator to
start a chemical reaction. This is the only purpose of the
CAIR listed substance. The CAIR listed substance is not a
component of the final product other than as an impurity.
Must Company A report as a processor under the CAIR?
A27. No. Use of a CAIR listed substance as an initiator of a
chemical reaction is considered an end-use. Therefore,
Company A is not required to report under the CAIR.
Q28. Company A manufactures a polymer final product. In the
process type, Company A uses a CAIR listed substance as a
chain terminator to limit the length of the polymer chain in
the final product to a predetermined length. Must Company A
report as a processor under the CAIR?
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A28. Yes. Company A is classified as a processor since use of a
CAIR listed substance as a chain terminator is a necessary
step in the manufacture of the polymer final product, and has
a direct effect on the types of end-uses the final product can
be used for.
Q29. Company A purchases a CAIR listed substance and places it in
a hopper above a reactor. The CAIR listed substance is used
as a reaction terminator designed to stop the reaction if the
reactor goes out of control. Must Company A report as a
processor under the CAIR?
A29. No. Use of a CAIR listed substance as a reaction terminator
is not a necessary step in the manufacture of a final product.
Therefore, Company A is classified as an end-user, and is not
required to report under the CAIR.
Q30. Company A purchases a paint which contains a CAIR listed
substance and uses it to stencil Company A's logo on the side
of galvanized metal bins which Company A distributes in
commerce. Must Company A report as a processor under the
CAIR?
A30. Analysis of this question requires a three step analysis:
(1) If a CAIR listed substance remains in the paint when the
metal bin is distributed in commerce, Company A is a processor
(article producer) and is required to report under the CAIR.
(2) If a CAIR listed substance reacts or polymerizes after it
is applied to the metal bins so that the paint no longer
contains the CAIR listed substance when the metal bin is
distributed in commerce, Company A is still a processor (an
article producer and a chemical producer) and is required to
report under the CAIR.
(3) If, however, a CAIR listed substance evaporates when it is
applied, Company A is an end-user of the CAIR listed substance
and is not required to report under the CAIR.
Q31. Company A is a paint contractor who paints industrial
equipment on its customer's facilities using paint that
contains a CAIR listed substance. Must Company A report as a
processor under the CAIR?
A3l. No. Company A is not distributing the equipment that it
paints in commerce. Rather, Company A is selling its
services, not the paint which contains a CAIR listed
substance. Therefore, Company A is an end-user and is not
required to report under the CAIR.
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Q32. Company A uses a CAIR listed substance in its quality control
lab as an analytical reagent. The CAIR listed substance is
not included in or handled by Company A's process type, nor is
the CAIR listed substance in Company A's final product. Must
Company A report as a processor under the CAIR?
A32. No. Use of a CAIR listed substance in a quality control lab
as an analytical reagent is classified as an end-use.
Therefore, Company A is not required to report under the CAIR.
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CORRESPONDENCE
Chemical Manufactures Association
December 22, 1988
Barbara Ostrow
Section Chief
Chemical Assessment Rule Section
Chemical Screening Branch
Office of Toxic Substances
401 M Street, S.W.
Room 447 - East Tower
Washington, D.C. 20460
Re: Clarification of CAIR Requirements
Dear Ms. Ostrow:
As you are aware, the Chemical Manufacturers Association (CMA)
has a continuing interest in the Comprehensive Assessment
Information Rule (CAIR). Consequently, CMA and its member companies
have been closely examining the prepublication draft of the CAIR
which you provided to us. Two questions have been raised by some
CMA members about the scope of CAIR reporting requirements. Because
of the practical importance of these issues, we are requesting that
EPA address them as soon as possible.
Definition of "Processing" Activities
The CAIR requires "processors" to report on certain chemicals
covered by the Rule. In such cases, respondents must complete the
portions of the CAIR form which seek information about "processing
activities."
Section 3(10) of TSCA defines "process" [as]
"the preparation of a chemical substance or mixture, after its
manufacture, for distribution in commerce—
(A) in the same form or physical state as, or in a
different form or physical state from, that in which it was
received by the person so preparing such substance or mixture,
or
(B) as part of an article containing the chemical
substance or mixture."
15 U.S.C., Section 2602(10) (emphasis added). Under this
definition, the key attribute of "processing" is "preparation" of
a substance, either in its original or an altered state, for
distribution in commerce.
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At 40 C.F.R., Section 704.3, the CAIR provides a defini-
tion of "process for commercial purposes" which closely
parallels the statutory definiiton. However, 40 C.F.R.,
Section 704.203 than defines "processing activities" in
terms that seem broader than the definition of "process":
"All those activities which include (1) preparation of a
substance identified in Subpart D of this Part after its
manufacture to make another substance for sale or use.
(2) repackaging of the identified substance, or (3)
purchasing and preparing the identified substance for use
or distribution in commerce."
This definition suggests that persons who prepare a substance
for use, rather than for distribution in commerce, would be engaged
in "processing activities" and therefore must report undr CAIR.
For example, if a company uses a CAIR chemical to clean equipment
or as an unreacted catalyst, these activities would seen to trigger
CAIR reporting requirements.
In the past, CMA members have assumed that chemicals which-are
consumed during their operations, but are not themselves offered
for sale or converted into other products that are offered for
sale, are outside the TSCA definition of "processing." Because the
CAIR seem to embody a different approach, EPA should clarify the
type of activities that will trigger processor reporting
requirements. Specifically, EPA should explain whether use activi-
ties that do not involve distribution in commerce are subject to
reporting. EPA should also address whether the term "process" and
"processing1 activities" are intended to have different meanings
and, if so, how these term function in the CAIR reporting scheme.
Reporting on Toluene Diisocvanate (TDI1
The CAIR requires reporting on four different versions of
toluene diisocyuate (TDI). The four listed substances are:
Cas Number Chemical Name
91-08-7 Benzene, l-3-diisocyanato-2-methyl-
(2,6-Toluene diisocyanate)
584-84-9 Benezene, 2,4-diisocyanato-l-methyl-
(2,4,-Toluene diisocyanate)
1321-38-6 Benezene, diisocyanatemethyl-
(unspecific toluene diisocyanate)
26471-62-5 Benezene, l-3-diisocyanatomethyl-
(2,4-2,6-Toluene diisocyanate)
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Typically, TDI is sold and processed as an 80/20 percent
mixture of the 2,4 and 2,6 isomers. This blend falls within CAS
No. 26471-62-5. According to the TDI producers, 2,4-TDI is
occassionally sold separately as a commercial product, but 2,4-TDI
and unspecific TDI are not available as items of commerce.
As EPA's Rule is now framed, it is theoretically possible that
manufacturers and processors of the mixed isomer blend would have
to submit four different reports—one for the mixture of 2,4 and
2,6 isomers, one for each individual isomers and a fourth report
for the unspecific TDI. The preparation of such multiple reports
would impose significantly increased burdens on TDI manufactures
and processors without yielding any additional information of
value to EPA.
A more efficient approach would be for manufacturers and
processors of the mixed isomer product to report once, under Gas
No. 26471-62-5. Reporting under the other CAS numbers would be
unnecessary unless a firm manufactures or processes 2,4-TDI as a
separate product. In this event, reports would be submitted under
Gas No. 584-84-9. Repots for the other two listed substances would
not be required because they are both available as commercially
discrete products.
We ask that EPA confirm the above interpretation of CAIR as it
applies to TDI products as soon as possible.
Please call Tim O'Leary of my staff at 202/887-1278 concerning
this matter.
Sincerely yours,
Geraldine V. Cox
Vice President-Technical Director
CC: Richard Sigman
Environmental Protection Agency
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
Jan 18, 1989
Geraldine V. Cox
Vice President-Technical Director
Chemical Manufacturers Association
2501 M Street, NW.
Washington, DC 20037
Dear Dr. Cox,
This letter is in response to your inquiry of December 22,
1988, which outlined two concerns raised by your member companies
relating to the Comprehensive Assessment Information Rule (CAIR).
The first concern relates to the difference between the
definitions "processing activities" and "process for commercial
purposes," and which of these definitions should be used to deter-
mine whether a person is a "processor" under CAIR. Specifically,
your member companies wish to know whether the preparation of a
substance identified in the CAIR "for sale or use" under the
definition of "processing activities," or the preparation of a
chemical substance "for distribution in commerce" under the
definition of "process for commercial purposes" should be used to
determine whether a person is a processor under the CAIR.
A person is a processor under the CAIR if he prepares a CAIR
listed substance "for distribution in commerce." The CAIR reporting
form uses the term "process" in its questions. This term is defined
in the glossary of the CAIR reporting form Instructions as "process
for commercial purposes." The CAIR reporting form does not use the
term "processing activities." The term "processing activities" is
used to describe when a final product is "prepared" for distribu-
tion in commerce. For example, a substance is not prepared for
distribution in commerce until it is ready for "sale or use." If a
substance is completely consumed on site (i.e., not prepared for
distribution in commerce), then the person processing that sub-
stance need not report under the CAIR. Note that a manufacturer or
importer who completely consumes a CAIR listed substance on site
must report under the CAIR, since that person manufactures a CAIR
listed substance "for an immediate or eventual commercial
advantage." This distinction is outlined in the CAIR Question and
Answer document, which will be mailed out with the CAIR reporting
form and Instructions.
The second concern raised by your member companies relates to
three of the four CAS Numbers of toluene diisocyanate (TDI) listed
in the CAIR. Specifically, how should a respondent report if he
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manufactures, imports, or processes a blend of the 2,4 isomer (CAS
No. 91-08-7) and 2,6 isomer (CAS No. 584-84-9), since this blend is
identified as CAS No. 26471-62-5, and is also a CAIR listed
substance.
CAS No. 26471-62-5 is classified in the TSCA Inventory as a
chemical substance that is composed of varying concentrations of
CAS Nos. 91-08-7 and 584-84-9. Therefore, if a person manufactures,
imports or processes CAS No. 26471-62-5, that person would report
for CAS No. 26471-62-5. If, however, a person manufactures, imports
or processes either CAS No. 91-08-7 or CAS No. 584-84-9 by itself,
that person would report as a manufacturer, importer or processor
of that particular CAS Number. This response is also outlined in
the CAIR Question and Answer document.
I hope that this response satisfies your member companies'
concerns. If you have any further questions, feel free to contact
my office.
Sincerely yours,
Joseph J. Merenda, Director
Existing Chemical Assessment Division
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
Mar 14, 1989
Geraldine V. Cox
Vice President-Technical Director
Chemical Manufacturers Association
2501 M Street, NW.
Washington, DC 20037
Dear Dr. Cox,
On December 22, 1988, the Chemical Manufacturers Association
(CMA) sent a written request to the Environmental Protection Agency
(EPA) (enclosed) asking EPA to clarify two questions raised by some
CMA members about the Comprehensive Assessment Information Rule
(CAIR) . EPA responded to this request on January 18, 1989
(enclosed). One response given by EPA, however, was misinterpreted
by some CMA members. CMA members requested during a meeting with
EPA staff members on February 7, 1989, that EPA clarify its use of
the phrase "consumed on site," as it is used in EPA's January 18
response letter. This letter is in response to that request.
In the third paragraph of its response letter, EPA stated that
"[ijf a substance is completely consumed on site (i.e., not
prepared for distribution in commerce), then the person processing
that substance need not report under the CAIR." CMA members
interpreted the phrase "consumed on site" to include the
consumption of a CAIR listed substance as a raw material in the
production of a completely different chemical substance (i.e., one
that doesn't contain the CAIR listed substance) via a chemical
reaction. This interpretation is incorrect. Under the CAIR, this
type of activity is considered processing under the "chemical
producer" guidelines set forth in question number 16 of the
December, 1988 CAIR Question and Answer Document. The phrase
"consumed on site" is intended to mean that a CAIR listed
substance is used on site as a final product (i.e., as an end-use
product versus as a raw material in a processing process type).
In order to further assist CMA members in determining whether
they are a manufacturer or a processor under the CAIR, EPA is
developing a second Question and Answer document that summarizes
how a person would report under various scenarios. This second
Question and Answer document will be completed in the near future,
and will be sent to CMA at that time.
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I hope that this clarifies EPA's use of the phrase "consumed
on site" as used in its January 18 repsonse letter. If you have
any further questions, please contact my office.
Sincerely yours,
Joseph J. Merenda, Director
Existing Chemical Assessment Division
Enclosure
cc: D. Stangel
A. Gordon
F.F. Stiehl
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
April 18, 1989
Ms. Sandy Cochran
Assistant to the
Executive Vice President
Edward Fields, Inc.
Box 4009
128-28 25th Avenue
College Point, NY 11356-4009
Dear Ms. Cochran,
This letter is in response to your April 6 inquiry (a copy
of which is enclosed) concerning the Comprehensive Assessment
Information Rule (CAIR). In your letter you requested written
confirmation that your company is not required to report under the
CAIR.
To summarize the facts outlined in your April 6 letter, Edward
Fields "processes" hydroxylamine sulfate 2:1 as a mild reducing
agent in the manufacture of carpets. Edward Fields' annual sales
are approximately $ 8.0 million, and the company handles less than
10,000 Ibs of hydroxylamine sulfate per year. Based on the
information as summarized in this letter, Edward Fields is a
"small" processor of hydroxylamine sulfate, and is therefore exempt
from reporting under the CAIR.
If you have any further questions concerning the CAIR,
please contact either the TSCA Assistance Office at (202) 5541404
or the CAIR Technical Assistance Office at 1-800-658-8823.
Sincerely yours,
Joseph J. Merenda, Director
Existing Chemical Assessment Division
Enclosure
cc: C.L. Elkins
A.E. Conroy
F.F. Stiehl
Interpretive Guidance File
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON/ D.C. 20460
April 18, 1989
Ms. Elizabeth A. Treanor
Organization Resources Counselors, Inc.
1910 Sunderland Place, NW.
Washington, DC 20036
Dear Ms. Treanor,
This letter is in response to your March 20 inquiry (a copy of
which is enclosed) concerning the Comprehensive Assessment
Information Rule.(CAIR). In your letter you requested responses to
three questions. I have enclosed a copy of the March, 1989 CAIR
Question and Answer document, and have detailed the scenarios that
respond to your questions below.
The first question relates to whether a manufacturer who
applies a sealant or paint containing a CAIR listed substance to an
article which is distributed in commerce is subject to the CAIR.
Scenario Numbers 18 through 22, and Numbers 26 through 27 in the
March, 1989 Question and Answer document respond to this question.
The second question relates to whether a "marketer" or a
"refiner" of a final product which contains a CAIR listed substance
(e.g., gasoline) is subject to the CAIR. Only manufacturers,
importers and processors are subject to the CAIR. Therefore, if by
a "marketer" you mean a "distributor," then the person is not sub-
ject to CAIR. Further, if by a "refiner" you mean a manufacturer of
a final product from a naturally occurring substance (i.e., a
"refiner" of crude oil to manufacture gasoline), then Scenario
Numbers 28 through 32 in the March, 1989 Question and Answer
document respond to "refiners" in general, while Scenario Number 33
in the March, 1989 Question and Answer document responds
specifically to a refiner who manufactures gasoline.
The third question relates to whether a CAIR listed Substance
that is present as a solvent and disperses is subject to the CAIR.
If your question relates to a CAIR listed substance that acts as a
solvent to keep a final product in solution; i.e., the CAIR listed
substance [??] of a final product which is distributed in commerce,
then Scenario Number 17 in the March, 1989 Question and Answer
document responds to this question. If your question relates to a
CAIR listed substance that is "used" as a solvent in a process
type, but is not a component of a final product which is distri-
buted in commerce, then Scenario Number 16 in the March, 1989
Question and Answer document responds to this question.
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If you have any further questions concerning the CAIR,
please contact either the TSCA Assistance Office at (202) 5541404
or the CAIR Technical Assistance Office at 1-800-658-8823.
Sincerely yours,
Joseph J. Merenda, Director
Existing Chemical Assessment Division
Enclosure
cc: C.L. Elkins
A.E. Conroy
F.F. Stiehl
Interpretive Guidance File
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
File copy
June 8 1989
Mr. Raymond W. Kenney
Uniroyal Chemical Company, Inc.
720 Fairport Nursery Road
Painesville, Ohio 44077
Dear Mr. Kenney,
This letter is in response to your May 16 inquiry (a copy of
which is enclosed) concerning the Comprehensive Assessment
Information Rule (CAIR). In your letter you requested a written
verification that Uniroyal Chemical is exempt from reporting for
your use of hydroxylamine sulfate (CAS Number 10039-54-0).
The facts outlined in your May 16 letter indicate that
Uniroyal Chemical Company manufactures a synthetic nitrile rubber
using hydroxylamine sulfate as a shortstop (i.e., as a chain
terminator) in the polymerization process.
The CAIR Technical Assistance Office's statements made on May
15, 1989, that the use of some terminators is classified as an
end-use activity, is true. When the purpose of a terminator is to
limit the length of a polymer chain, however, this activity is
classified as a processing activity, not an end-use. This is
because the use of a chain terminator is a necessary step in a
polymerization reaction and has a direct effect on the possible
end-uses of a polymer final product. Therefore, Uniroyal Chemical
Company is subject to the reporting requirements of 40 CFR Part 704
Subpart C as a "chemical producer" of hydroxylamine sulfate.
EPA regrets that Uniroyal was given incorrect information and
apologizes for the inconvenience. Due to the incorrect response
given to you by the CAIR Technical Assistance Office on May 15,
1989, EPA is granting an automatic thirty day extension to Uniroyal
Chemical's reporting deadline for the processing activities
outlined in this letter. Uniroyal Chemical's new reporting deadline
for these activities is July 7, 1989.
[No further page(s) found]
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[DATE/SOURCE?] QUESTIONS AND ANSWERS RESPONDING TO
THE FEBRUARY 16. 1989 LETTER FROM 3M
Ql. 3M is not a manufacturer or importer of TDI, but in some cases
does react TDI completely to a polymer wherein no intentional TDI
remains. The TDI is entirely consumed on-site. The polymer is then
used in the production of various articles by 3M which are then
distributed in commerce. A letter from J. J. Merenda, Director
ECAD, to Geraldine V. Cox of the Chemical Manufacturers'
Association, dated 1/18/89, states the following:
If a substance is completely consumed on-site (i.e., not prepared
for distribution in commerce), then the person processing that
substance need not report under the CAIR.
Answer 65 of the CAIR Q&A, final paragraph, makes a similar
statement. These lead us to conclude that we do not need to report
on this process. However, page 8 of the same CAIR Q&A, (2) under
Processing, suggests that if we entirely react the TDI we must
report as a processor. This appears to be in conflict with Mr.
Merenda's letter. Therefore, we would appreciate your clarifying
whether we must report as a processor where we completely react the
TDI to a polymer.
Al. This misinterpretation by CMA and its member companies of the
January 18, 1989 letter from Joe Merenda to Geraldine Cox was
clarified in a subsequent letter from Joe Merenda to Geraldine Cox,
dated March 14, 1989 (a copy of which is enclosed).
Under the facts outlined in this question,. 3M is classified
as a "chemical producer," since 3M processes TDI by reacting it to
produce a polymer that is then incorporated in an article which is
distributed in commerce. This scenario is outlined in Number 24 of
the March, 1989 CAIR Question and Answer document (a copy of which
is enclosed).
Section 1
Q2. Question 1.03: Does this question refer to the Federal Register
notice that lists trade names? If 3M chooses to respond to the form
prior to this notice or notice from our suppliers, are we required
to fill out this question?
A2. This question refers to either the December 22, 1988 CAIR rule
or the Federal Register notice that lists trade names,
whichever notice imposes a requirement that a person report.
If 3M wishes to respond to the form prior to the publication
of tradenames in the Federal Register or prior to being notified by
3M's suppliers, 3M must contact its suppliers and determine how
they intend to notify 3M, and answer Question 1.03 through Question
1.05 appropriately.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
June 30, 1989
Mr. James W. Wiersma
Director of Human and
Financial Resources
Sparks Belting Company
3800 Stahl Drive, SE
Grand Rapids, Michigan 49506
Dear Mr. Wiersma,
This letter is in response to your June 6 inquiry (a copy of
which is enclosed), and your June 23 telephone conversation with
one of my staff, Robert Thompson, concerning the Comprehensive
Assessment Information Rule (CAIR).
In your letter you requested an extension of your reporting
deadline, and noted that you believed that Sparks Belting was
exempt from reporting under the CAIR. Your telephone conversation
with Robert Thompson confirmed the fact that Sparks Belting's use
of MBOCA as a catalyst is an end-use activity; and that Sparks
Belting is therefore not required to report under the CAIR.
i
I am glad my staff was able to assist you in this matter.
Sincerely yours,
Joseph J. M rector
Existing Chemical Assessment Division
Enclosure
cc: C.L. Elkins
A.E. Conroy
F.F. Stiehl
Interpretive Guidance File
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTION, D.C. 20460
Oct 24, 1989
Mr. Thomas B. Johnston
McKenna, Conner & Cuneo
1575 Eye Street, N.W.
Washington, D.C. 20005
Dear Mr. Johnston:
This letter confirms the information you received from Mr.
Michael Lease of SAIC concerning the definition of processing
activities under the Comprehensive Assessment Information Rule
(CAIR).
EPA's interpretation of that definition under CAIR classifies
the activities described in your letter of September 20, 1989 [*]
to the CAIR Office as an end-use and therefore not requiring
reporting under CAIR.
Very truly yours,
Charles M. Auer, Acting Director
Existing Chemical Assessment Division
cc: Interpretive Guidance File
[*] copy follows
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LAW OFFICES
MCKENNA, CONNER & CUNEO
1575 EYE STREET, N.W.
WASHINGTION, D. C. 20005
September 20, 1989
CAIR Office
c/o SAIC
8400 West Park Drive
McLean, VA 22102
Attention: Michael Lease
Re; CAIR Definition of "Processing Activities"
Dear Mr. Lease:
This letter follows up on our telephone conference earlier
today. We request that you arrange for the U.S. Environmental
Protection Agency to confirm in writing your interpretation of the
definition of "processing activities" under the Comprehensive
Assessment Information Rule (CAIR). 53 Fed. Reg. 51,698, 51,718
(December 22, 1988) (to be codified at 40 C.F.R. SS 704.203).
The CAIR defines "processing activities" to mean "all those
activities which include (1) . . . , (2) repackaging of the identi-
fied substance. Id. (emphasis added). We request confirmation that
"processing activities" does not include purchasing a chemical
substance in bulk containers and transferring it to smaller con-
tainers if the chemical is not distributed in commerce thereafter,
but merely used on-site. This is a common practice in many types of
industries, and placing CAIR reporting obligations on such
companies, which are merely users of the chemicals, does not appear
to be authorized by the applicable sections of the Toxic Substances
Control Act.
Thank you for your attention to this matter.
Sincerely,
Thomas B. Johnston
TBJ:gj
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"TSCA INVENTORY"
Part 710 — Inventory Reporting Regulations
Subpart A - Compilation of the Inventory
40 CFR §710.2(f), "article" is defined as "a manufactured
item: (1) Which is formed to a specific shape or design during
manufacture, (2) which has end use function(s) dependent in whole
or in part upon its shape or design during end use, and (3) which
has either no change of chemical composition during its end use or
only those changes of composition which have no commercial purpose
separate from that of the article and that may occur as described
in §710.4(d)(5); except that fluids and particles are not
considered articles regardless of shape or design."
40 CFR §710.4(d) provides the following information regarding
chemical substances excluded from the directory: "The following
chemical substances are excluded from the inventory. Although they
are considered to be manufactured or processed for a commercial
purpose for the purpose of Section 8 of the Act, they are not
manufactured or processed for distribution in commerce as chemical
substances per se and have no commercial purpose separate from the
substance, mixture, or article of which they may be a part: . . .
(5) Any chemical substance which results from a chemical reaction
that occurs upon end use of other chemical substances, mixtures, or
articles such as adhesives, paints, miscellaneous cleansers or
other housekeeping products, fuels and fuel additives, water
softening and treatment agents, photographic films, batteries,
matches, and safety flares, and which is not itself manufactured
for distribution in commerce or for use as an intermediate."
According to 40 CFR §710.2(t), the term "Process" is defined
to mean "the preparation of a chemical substance or mixture, after
its manufacture, for distribution in commerce (1) in the same form
or physical state as, or in a different form or physical state
from, that in which it was received by the person so preparing such
substance or mixture, or (2) as part of a mixture or article
containing the chemical substance or mixture."
40 CFR §710.2(u) defines the term "Process for commercial
purposes" to mean "to process (1) for distribution in commerce,
including for test marketing purposes, or (2) for use as an
intermediate."
40 CFR §710.2(n) defines the term "Intermediate" to be "any
chemical substance: (1) Which is intentionally removed from the
equipment in which it is manufactured, and (2) which either is
consumed in whole or in part in chemical reaction(s) used for the
intentional manufacture of other chemical substance(s) or mix-
ture (s), or is intentionally present for the purpose of altering
the rate of such chemical reaction(s)."
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40 CFR §710.2(v) defines a "Processor" to be "any person who
processes a chemical substance or mixture."
FEDERAL REGISTER NOTICES
EPA Responses to Comments 4 and 5 in the Notice entitled
"Availability of TSCA Initial Inventory; Beginning of 210-Day
Reporting Period for Revised Inventory" (44 FR 28563):
"Comment 4; EPA should recognize that the terms
•processor1 and 'user1 are not synonymous. If the
definition of 'user'is restricted to one who 'processes'
a chemical substance for commercial purposes, a: person
who uses a chemical substance to lubricate or clean
machinery, for example, would be prevented from adding
the substance to the Inventory, and would risk having his
supply of the substance interrupted.
"Response; EPA recognizes that there is a distinction
between processors and users of chemical substances.
This distinction, however, is irrelevant for purposes of
Inventory reporting. Under Section 8(b) of TSCA, the
Inventory is to include substances which have been
manufactured (including imported) or processed for
commercial purposes in the United States since January 1,
1975. The Inventory reporting regulations permit users
of chemical subsances to report substances that have been
manufactured or processed for commercial purposes since
1975, regardless of whether the user of the substance
also manufactures or processes the substance. An
eligible substance that is used to lubricate or clean
equipment may be reported for the Inventory by a user if
it has been manufactured or processed since 1975."
"Comment 5: If a substance reported by a processor
during the 210-day period cannot be manufactured until it
is included on the Inventory, the processor risks an
interruption in his supply of the substance until the
Revised Inventory is published in 1980.
"Response: EPA does not wish to impose eceonomic hard-
ships on processors by contributing to the interruption
of supplies of chemical substances. Therefore, once a
processor reports a substance and receives the postcard
from EPA acknowledging receipt of the report form, his
supplier may continue to manufacture the substance.
However, EPA intends to survey reports from processors to
determine whether the supplier is a manufacturer who
should have reported the substance for the Initial
Inventory.
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"Although manufacture of the substance may continue once
the acknowledgement postcard is received, this does not
mean that the substance is included on the Inventory at
that time. EPA must first determine whether the sub-
stance was reported in accordance with the Inventory
reporting regulations, i.e., the substance is eligible
for inclusion on the Inventory. If there are any
problems with the report, EPA will notify the submitter,
who will be given an opportunity to make necessary
corrections to the report. If the submitter does not
make the appropriate amendments to the report, EPA cannot
process the form and the substance will not be added to
the Inventory unless it is reported by someone else.
Thereafter, manufacture of the substance for a use sub-
ject to premanufacture notification requirements would be
illegal."
In the same FR Notice cited above, under "Reporting for
Revised Inventory. I. Who May Report" (44 FR 28561):
"1. a person who has processed or used a chemical sub-
stance (including use in the manufacture of a mixture or
article containing that chemical substance) for a com-
mercial purpose since January 1, 1975, or
"2. a person who has imported a chemical substance as
part of a mixture or article for a commercial purpose
since January 1, 1975."
From the Inventory Reporting Regulations (December 23, 1977),
the following paragraph concerning DEFINITIONS appears in the
Preamble (42 FR 64574):
"EPA wishes to emphasize that the terms used in these
regulations may not be wholly consistent with the
ordinary usage of such terms. For example, the term
'manufacturer1 includes importers. As used in these
regulations, the terms 'manufacturer1 and 'processor' may
both apply to a person who normally would consider him-
self one or the other. "Intermediate" refers only to
those intermediates which are isolated or removed from
the equipment in which they are manufactured. Persons
should be sure they understand the special meanings of
the terms used for purposes of these regulations.
In Part 710. 3 (c) of the Inventory Reporting Regulations (42 FR
64577) :
"(c) Persons not subject to the initial Inventory.
Persons who have only processed or used a chemical sub-
stance for a commercial purpose are not subject to the
initial Inventory requirements."
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In the Instructions For Reporting for the Revised Inventory
(June 1979), on page 5, the following passage describes who may
report:
"A. Who May Report
"The following persons may report a chemical substance
that is not included on the published Initial Inventory
for inclusion on the Revised Inventory:
"(1) a person who has processed or used a chemical
substance (including use in the manufacture of a mixture
or article containing that chemical substance),, for a
commercial purpose since January 1, 1975."
On page 9 of this June, 1979 instructions manual for the
Revised Inventory is a paragraph under part D: How to Determine
Whether to Report:
"In general, if a processor has received written
certification from his suppliers that all component
chemical substances in the product(s) he processes have
been reported for the Inventory, the processor should not
be concerned about reporting."
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"PAIR"
CODE OF FEDERAL REGULATIONS (CFR)
Part 712 — Chemical Information Rules
Subpart A - General Provisions
According to 40 CFR §712.3, all definitions that are given in
section 3 of TSCA apply to this part. In addition, 40 CFR §712.3
provides the following definitions.
40 CFR §712.3(m) defines "Process for commercial purposes" as
"the preparation of a chemical substance or mixture, after its
manufacture, for distribution in commerce with the purpose of
obtaining an immediate or eventual commercial advantage for the
processor. Processing of any amount of a chemical substance or
mixture is included. If a chemical or mixture containing impurities
is processed for commercial purposes, then those impurities are
also processed for commercial purposes."
PROPOSED RULE
Federal Register / Vol. 45, No. 42 / Friday, February 29, 1980
/ Proposed Rules / Starting Page 13646
40 CFR Part 712
[OTS-082004b; FRL 1385-4]
Pesticides and Toxic Substances;
General Recordkeeping and Reporting
Requirement: Preliminary Assessment
Information
ACTION: Proposed rule; notice of opportunity to comment.
SUMMARY: This rule, proposed under the authority of section 8(a) of
the Toxic Substances Control Act (TSCA), would require chemical
manufacturers (including miners and importers) and, in some cases,
processors to report production and exposure-related data on
approximately 2300 chemicals to the EPA. This information will be
used both for ranking chemicals for investigation and for
preliminary risk assessments Additional chemicals may be added to
this rule in the future; therefore, any chemical manufacturer or
processor is potentially subject to the proposed requirement.
Comments are requested on both the general procedures of this rule
and the chemicals proposed at this time
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l . Background
A. Legal Authority
Section 8 (a) of the Toxic Substances Control Act (TSCA) , 15
U.S.C. 2607(a), authorizes the Administrator to promulgate rules
"under which . . . each person . . . who manufactures or
processes or proposes to manufacture or process a chemical
substance . . . shall maintain such records, and shall submit to
the Administrator such reports, as the Administrator may reasonably
require." [emphasis added]. See TSCA section 8(a)(l)(A). In the
case of manufacturers or processors of mixtures or of small
quantities of research and development chemicals these rules may
require maintenance of records and submission of reports "to the
extent . . . necessary for the effective enforcement of this
Act." [emphasis added] . See TSCA section 8 (a) (1) (B) . Section 8 (a)
rules may require a manufacturer or processor to submit any
applicable data "insofar as known to the person making the report
or insofar as reasonably ascertainable [emphasis added] . See TSCA
section 8 (a) (2) .
Thus, the standards governing EPA's information gathering
authority under section 8 (a) are that reporting and recordkeeping
requirements be "reasonable" (or "necessary for effective
enforcement of this Act") and that the information required in the
report be "known to" or "reasonably ascertainable" by the reporting
person.
Section 8, also, imposes certain limitations on the Agency's
information gathering authority. To the extent feasible EPA is not
to require any unnecessary or duplicative reporting. See TSCA
section 8 (a) (2). For purposes of section 8 (a), manufacturers and
processors are persons who manufacture or process chemicals "for
commercial purposes" (see TSCA section 8(f)) . Furthermore, section
8 (a) generally exempts small manufacturers or processors from the
provisions of section 8 (a) rules, although these persons may be
subject to 8 (a) under certain circumstances. See TSCA section
D. Comments Somght
The Agency urges all manufacturers, importers, and processors
of chemical substances and mixtures to comment on this proposal
whether or not they are associated with the chemicals proposed now.
It should be assumed that any chemical substance or mixture may in
the future become subject to the promulgated rule. The reporting
and recordkeeping provisions of the rule will remain the same once
the rule is promulgated, but the list of chemicals subject to these
requirements will be increased by amendment. Comments will be
solicited in the future on the chemicals to be added. Comments on
the requirements and procedures of the rule should be submitted
now.
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On June 27,1979, EPA published an Advance Notice of Proposed
Rulemaking (ANPR), 44 FR 37517, soliciting comment on proposing
this type of rule. Many informative comments were received in
response. In addition, EPA staff have met with interested persons
from public interest groups and from the chemical industry.
Comments received and minutes of meetings are available in the
public record of this rulemaking.
2. Contents of the Rule
A. Summary
This proposal consists of a rule with a reporting form. The
proposal contains two phases of reporting. First manufacturers and
importers of specified chemical substances would be required to
answer general questions concerning production, use, and methods of
processing with regard to those chemicals, including use of the
chemicals by their customers. Second, if manufacturers or
importers have been unable to report customer uses, their customers
may be required to submit this information to EPA. This subsequent
customer reporting would not be required unless the aggregated data
from the initial reports on a particular chemical are insufficient
for evaluation
C. Who Must Report
The proposed rule would require the manufacturers, including
importers, of the chemicals listed in section 712.18(a) to complete
and submit the proposed EPA form (see Appendix I of the proposed
rule) within 60 days of the effective date of the rule. The direct
customers of manufacturers would be subject to subsequent reporting
of the information requested in Part B of the form, but only if
manufacturers cannot supply sufficient information. The customers
required to report would be processors or manufacturers. Persons
who mine chemical substances are manufacturers and are subject to
initial reporting. Customers could include repackagers, persons
who incorporate chemical substances into mixtures or articles,and
persons who react chemical substances.
The following manufacturers and importers would be excluded
from the initial•requirement to submit the form. Each proposed
exclusion will be reconsidered in response to public comment. The
final rule may include some persons covered by the proposed
exclusions. Therefore, commenters should address these exclusions
with this possibility in mind
(2) Small manufacturers and importers. (See section 7 of this
preamble, "Small Manufacturers and Processors".)
(7) Manufacturers and importers of mixtures. Unless they also
manufacture the chemical substance(s) they mix, mixture
manufacturers are only subject to subsequent customer reporting.
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Further, this subsequent report would not be required if their
activities are adequately described by the manufacturers of the
chemical substance(s) in the initial reporting under the rule.
Manufacturers of mixtures are processors of the chemical substances
they mix. (A person may both manufacture a chemical substance and
formulate a mixture containing that substance; in which case, he
would be subject to the initial reporting requirement.)
While this rule is not directed to information about mixtures
per se, it will under the customer reporting requirements (see
section 3 of the preamble) require submission of information by
persons who manufacture or process mixtures. To the extent that
information is required from such persons, such information will be
necessary to establish exposure and use information that will aid
the Administrator in invoking the provisions of TSCA. Accordingly,
the Administrator finds that it is necessary for effective
enforcement of TSCA to obtain limited information on mixtures under
this rule
In general, having the persons listed above report initially
would result in a burden that may not be justified for the purposes
of this rule. Information that might be provided by those excluded
can be obtained as needed either through customer reports under
this rule or, for fewer chemicals, under subsequent section 8
rules. Since the purpose of the rule is to identify chemicals with
major exposure potentials, the Agency believes the general
information that can be provided by primary manufacturers and
importers and a few selected customers will be sufficient.
Commenters should address this view when commenting on the
exclusions. For chemicals that might indirectly present exposure
risks (e.g., via impurity contamination or as components of
articles) additional, more detailed information will be obtained
under the General and Detailed Assessment Information Rules—after
a significant suspicion of toxicity hazards has been identified.
The Agency requests comments on the appropriateness of the
proposed exclusions.
D. Content of the -Reporting Form
The proposed form would require reports of the quantities of
a chemical that are being handled in various ways by both
industrial workers and the general population. It would also
indicate how much of the chemical is released to the environment.
For details of the- form, see "Preliminary Assessment Information
Report", with instructions, which appears in Appendix I.
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Form Part A; Manufacturers' Activities
Part A of the form requires the chemical manufacturing company
to answer questions describing its methods of manufacturing and its
own uses of the reported chemical after manufacture. The parent
company is to report the data on one form for all plant sites it
owns or controls. The parent company owns or controls another
company if the parent owns or controls 50% or more of the other
company's voting stock. Companies must report how much of the
chemical was made and how much was lost to the environment for the
previous calendar year. Respondents must identify the general
manufacturing process types employed (open, controlled release, or
enclosed), the number of workers involved, how much of the chemical
was used and over what period of time. The headquarters or parent
company then must report on its own plants' and subsidiaries' uses
in three broad categories of use: (1) "Use as a Reactant", where
the chemical is reacted and therefore no longer exists as such; (2)
"Use Other Than as a Reactant", where the chemical is not changed;
and (3) "Consumer Products", where the company also produces a
consumer product containing the chemical.2 The Agency requests
comments on whether reporting should be by headquarters, as
proposed, or by individual plant sites.
In question 4, the form asks the manufacturer to identify by
process type the total quantity of the chemical manufactured, the
number of workers and the length of time they work with the
chemical. So that total worker exposure at manufacturing plant
sites is not underestimated, the submitter should report total
chemical production, regardless of its ultimate use. All other
questions refer only to chemical production regulable under TSCA.
(See the discussion under section 4, part D "Information on
Non-TSCA Uses".)
For use in consumer products, question 7, persons must
identify the type of exposure potential possible to the consumer
simply by describing the chemical as being part of an article that
does or does not release the chemical during normal use, or as
being a substance or a mixture that is itself used by the consumer.
This section also asks how much of the chemical the manufacturer
sells to persons who only distribute the chemical. Use of the
chemical by customers is to be reported under Part B.
Form Part B; Use of the Chemical by Others
In many cases a manufacturer or importer sells a chemical to
another company that, in turn, manufactures another chemical
substance, makes a mixture, or otherwise prepares a substance for
2Note: The "use" to which a manufacturer or a manufacturer's
customer puts a chemical may technically be described as
"processing" as defined in section 3 of TSCA.
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distribution. In Part B of the form manufacturers are to report on
their customers' use of the chemical. Manufacturers are asked to
specify how much of the chemical is reacted or not reacted by the
customers, what process types they use, and how much of the
chemical is incorporated into articles. Manufacturers are also
asked if their customers incorporate the chemical into consumer
products and, if so, how much goes into articles or is used
directly by consumers.
Question 12 asks for the quantity of the chemical that is
exported in bulk. This quantity subtracted from the total
production will aid in estimating the amount of the chemical that
is used in the United States that may be released in this country.
The Agency has explored other sources for this information in
developing regulations under TSCA section 12, notice of exportation
(see proposed rule, 44 FR 56857). While the Census Bureau does
monitor exports, this information is not chemical-specific (i.e.,
figures are kept on broad categories of chemicals).
E. Reporting Schedule and Procedure
The proposed rule contains two rounds of reporting: (1)
initial reports on the form by manufacturers and importers of
specified chemicals and (2) subsequent reports for Part B of the
form by certain customers of those initial respondents.
The proposal requires manufacturers and importers to maintain
records of their customers. The records of customers using a
particular chemical would be submitted to the EPA if, after
aggregation and evaluation of the forms received in the initial
reporting, the Agency determines that the manufacturer reported
significant quantities of customers use or exposure as "unknown".
The records then would be used to identify the customers who must
report under the subsequent reporting requirement. EPA would
contact the customers by letter instructing them to supply the
information in Part B of the form. Customers would be subject to
this reporting for a period of two years after the effective date
of the rule.
Customers who may have to report will be the immediate
customers of the manufacturers or importers filing initial reports.
Such customers could include makers of mixtures, other chemical
substances, and articles, and repackagers. The Agency has
authority to require subsequent reports from chemical manufacturers
and processors further down the commercial chain, e.g., from the
customers of the mixture maker or repackager. However, this could
require a very large number of time-consuming rounds of reports,
letters for customer lists, and letters to the appropriate
customers. The issue of who should report is discussed more fully
in section 3 of this preamble.
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F. Customer Lists
As described above, manufacturers and importers must maintain
customer records for a period of two years. EPA could, under the
rule, send a certified letter to a company requiring submission of
a list of customers for which that company did not report uses or
exposures (the complete customer records would also be subject to
inspection under section 11 of TSCA). EPA would use this list to
decide which customers should submit subsequent reports. Submission
of customer lists would be required only when significant quanti-
ties for customer activities were reported as unknown in the
initial manufacturer reports and the toxicity of the chemical is
either significant or unknown. The amount of this unknown infor-
mation would also have to be great enough to make it impracticable
to complete evaluation of the chemical.
Section 712.18(b) of the rule is reserved for a separate list
of chemicals for which customer lists would be submitted at the
same time as the form. At present EPA has not identified any
chemicals for this list. However, in the future, chemicals for
which immediate customer identification is necessary may be pro-
posed. The Agency will propose for comment the chemical substances
for which customer lists are to be submitted immediately and the
reasons they are needed.
Industry comments have expressed much concern over providing
customer lists to EPA because of their competitive value. However,
EPA will safeguard any information determined to be confidential
business information as provided in 40 CFR Part 2, as amended on
September 8, 1978 (43 FR 39997) and March 23, 1979 (44 FR 17673).
The Agency is also considering the alternative of a general
requirement for all customers to report for those chemicals whose
uses are unknown to their manufacturers. As described above, the
Agency would review the manufacturers' forms and would identify
chemicals where significant quantities were reported as unknown
with respect to customer uses. OPTS would then issue, under this
rule, a Federal Register notice that would be effective without
further comment for those chemicals. The requirement would state
that all persons who purchase any one of the specified chemical
substances from its manufacturer must report the use information
for Part B of the form. This alternative, because it would not be
as selective as the proposed contact of listed customers, would
increase the number of customers who have to report; however, it
would avoid the problem of submission of sensitive customer lists
to EPA. One difficulty may be that some customers who buy trade-
name products would not know they are subject to reporting, unless
specifically notified by the manufacturer or EPA.
3. Issues and Comments Received on the Reporting of Uses and
Exposures
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A. Knowledge of Customers' Uses
The Advance Notice of Proposed Rulemaking requested comments
on the sufficiency of manufacturers' and importers' knowledge of
their customers' uses and methods of processing. Most industry
commenters said that only their customers would have..specific use
information. Many industry commenters said they would not have
exposure-related information for their customers. Nonetheless,
many also agreed that manufacturers do know general information of
the kind appearing in this proposed rule. This knowledge could be
significantly limited, they said, depending on the following
factors:
(1) Production volume — Large volume manufacturers can
identify the major uses for the chemical which account for a large
percentage of their production, but may not know minor uses.
(2) Use of distributors — If the manufacturer sells to a
distributor, he may or may not know the chemical's uses.
(3) Specialty chemicals and proprietary products — Uses of
specialty chemicals may be proprietary and may not be revealed to
a manufacturer since he is a potential competitor.
For (1) and (3), where manufacturers do not know their cus-
tomers' uses, EPA will contact the customers as needed. For sale
to distributors, however, under section 8(a) of TSCA, the Agency
cannot require reports from distributors. The proposal does
include a provision to report how much was sold to distributors and
to record them as customers. EPA could then request the distri-
butors to voluntarily supply information. If significant quantities
are sold to distributors and information is not given voluntarily,
it may be necessary to require reports under another rulemaking
from all processors who buy from distributors.
One of the points made by industry commenters was that they do
not generally know exposure related information for their
customers' plant sites or products. The form does not directly ask
manufacturers to describe exposure as such. Instead, it asks for
the types of processes used by the customers and whether consumer
articles or mixtures are made by them. EPA will then arrive at
exposure potentials from this information. Some industry comments
have indicated that this information is often known.
Perhaps the most significant issue raised by industry
representatives is that while a company knows how its customers use
a chemical, such information may be subject to formal or informal
agreements to keep the information confidential. EPA has the
authority to obtain such information insofar as it is known or
reasonably ascertainable, regardless of any secrecy agreements.
However, this rule does not propose requiring reporting of this
information for the following reasons: (1) for the most part,
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manufacturers can describe their customers' uses in the general
categories provided without revealing significant trade secrets and
(2) the rule provides customers the opportunity to make and
substantiate claims of confidentiality to EPA. The rule instead
allows manufacturers to report uses and exposures that are either
truly unknown or subject to secrecy agreements as "unknown". EPA
would then have the option of obtaining a report, together with the
confidentiality claims, directly from the customer
C. Subsequent Reports by Customers
As proposed, the rule would require reports from customers
upon notification by certified letter from EPA. Customers would
provide the information the manufacturers were unable to provide in
Part B of EPA Form No. 7710-35. The Agency may use the same form
or develop a slightly modified form for customer reports.
Customers would only have to report information on their own
activities. The required accuracy of reported quantities would be
the same as it is for manufacturers making initial reports on their
own activities. "Small" manufacturers and processors would not be
subject to this requirement (see section 7, below, "Small
Manufacturers and Processors"). This follow-up provision would
only be used when significant quantities of the chemical are
reported by all manufacturers under the "unknown" category. EPA
has the authority to require all manufacturers and processors to
report initially; however, this approach is proposed in an effort
to reduce the reporting burden.
Some industry commenters have suggested that all customers be
required to submit subsequent reports so that companies who have
not had their activities described by manufacturers are not
burdened more than those who have. However, the proposed rule was
designed with an effort to minimize the overall reporting burden on
industry; the result of universal follow-up would be to defeat this
effort and to duplicate information that is reported by
manufacturers.
The Agency solicits comment on whether all customers should be
required to submit subsequent reports, whether sampling is
possible, or whether only customers whose activities are unknown
should report.
4. Issues and Comments on Reporting Information Under Section 8(a)
The Agency has received comment that it should obtain under
this rule sufficient data to conduct complete risk assessments for
as many chemicals as possible. While the Agency would prefer to
have ready access to complete data on any chemical that may come to
its attention, this is not practical or feasible. The Agency
simply does not have the resources to examine in a relatively short
period of time detailed data on large numbers of chemicals. EPA
believes it is unnecessary to subject chemical manufacturers and
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processors to such a substantial reporting burden in order to
supply EPA with information that will become significantly outdated
before it can be reviewed. Because of this resource limitation and
the burden on industry, OPTS has developed the assessment process
and corresponding reporting rules described below
B. Preliminary Assessment Process
EPA has determined that it should obtain broad use-exposure
data for purposes of this rule for several reasons. First, finer
details would be lost and unnecessary in the process of setting
relative priorities among a few thousand chemicals. Second, it is
more likely that manufacturers will more accurately be able to
describe their customers' activities by such categories. Third,
these broad categories should obviate most problems of revealing
customer trade secrets. Fourth, in developing the form, the Agency
found that the alternative to this simple set of categories is a
significantly more complex system. For example, in an effort to
describe the possible uses of chemicals the Agency had developed a
list of several thousand function and application terms ("Chemical
Use List", 43 FR 32222). These in turn would have to be related to
a measure of exposure for each use. Not only is such detail
unnecessary for preliminary assessment, it would be highly resource
intensive for both EPA and industry given the large number of
chemicals involved. Such an exercise is more appropriate for the
later section 8(a) rules that concentrate on fewer chemicals. The
Agency thinks the proposed form will obtain valuable information
for both priority-setting and preliminary assessment
Information concerning process types and the number of workers
involved in manufacture and industrial use (form questions 4, 5, 6,
and 9) relates primarily to an assessment of occupational exposure.
The information on process types can also be used for environmental
release estimates. This information is thus useful for assessments
of general population exposure
D. Information on Non-TSCA Uses
TSCA gives EPA regulatory authority over "chemical
substances" and "mixtures." Section 3(2)(B) of TSCA excludes
several types of chemicals from the definition of the term
"chemical substance." Among these exclusions are the following:
(ii) any pesticide (as defined in the Federal Insecticide,
Fungicide and Rodenticide Act [FIFRA]) when manufactured, pro-
cessed, or distributed in commerce for use as a pesticide, ....
(vi) any food, food additive, drug, cosmetic, or device (as
such terms are defined in section 201 of the Federal Food, Drug and
Cosmetic Act [FFDCA]) when manufactured, processed, or distributed
in commerce for use as a food, food additive, drug, cosmetic or
device.
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Many chemicals subject to regulation under FIFRA or the FFDCA,
however are also used as chemical substances which may be regulated
under TSCA. Part of a company's production or use may be subject
to TSCA and part subject to regulation under the other authorities.
For EPA's interpretation on when the different statutes are appli-
cable in specific circumstances see 42 FR 64585-86 (1977) and 43 FR
11115-16 (1978).
On question 4 of EPA Form No. 7710-35, the Agency proposes to
require a manufacturer to report the total quantity of the chemical
he manufactures (including quantities not regulable under TSCA) and
to report information on the number of people who work with the
chemical and for how long. EPA requests total chemical production
information in order to insure that the worker exposure to the
chemical is not underestimated. The risk of worker exposure is
independent of the statutory authority under which the chemical may
be regulated.
EPA believes it has the authority to obtain information on the
total quantity of chemical produced by a manufacturer even though
some of that production is beyond EPA's regulatory authority.
Section 8(a) authorizes EPA to obtain from chemical manufacturers
such information as the Agency may "reasonably require". In the
very limited circumstances of this rule it is reasonable for EPA to
require information on total chemical production in order to
properly assess worker exposure and set priorities. Further,
persons required to report will experience a negligible incremental
burden in reporting total chemical production as opposed to only
TSCA production.
EPA realizes that its position on this issue may be contro-
versial and the Agency especially solicits comments on the
authority it is asserting to obtain limited production data on
non-TSCA chemicals that are also regulable under TSCA. EPA also
solicits suggestions on methods to properly assess worker exposure
without obtaining data on total production of the chemical to which
the worker may be exposed. Note that section 8 (a) (2) of TSCA
specifically states that EPA may obtain data on the number of
workers exposed to a chemical substance and duration of such
exposure. The Agency believes that worker exposure to a particular
chemical stream cannot reasonably be separated into the exposure to
the TSCA and non-TSCA regulable proportions
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6. Definitions
Most of the definitions in this proposal are taken, some with
minor and nonsubstantive modifications, from the [TSCA] Inventory
Reporting Regulations, 40 .CFR 710.2, the proposed Premanufacture
Notification Rule, 44 FR 2264, and the proposed Health and Safety
Study Reporting Rule, 44 FR 77470.
7. Small Manufacturers and Processors
Section 8(a)(3) requires the Administrator to prescribe, by
rule, standards for determining who may qualify as a small
manufacturer or processor. Such small businesses are then exempt
from section 8(a) rule requirements, unless the chemical substance
manufactured or processed is subject to certain proposed or final
actions by the Agency, including section 4 test rules. It is
possible that some of the chemicals proposed for this rule will be
subject to proposed test rules under TSCA section 4 when this rule
is promulgated. In that case, small manufacturers and processors
would be subject to reporting for those chemicals. The following
small business exclusion is proposed for this rule:
No manufacturing or processing company must report for a
chemical substance if:
(1) its total sales for all products at all sites together are
less than $30 million for the reportable year, AND
(2) its production volume at each site for the chemical
reported was less than 100,000 pounds (45,400 kilograms) for the
reportable year.
The reportable year is 1979 for these proposed chemicals.
Figures would be based on activities at all of the plant sites
controlled or owned by the reporting parent company. The parent
company owns or controls another company if the parent owns or
controls 50% or more of the other company's voting stock.
The Agency has done an economic analysis for this proposed
rule using the reports from the Inventory Reporting Regulation (40
CFR 710) and Dun and Bradstreet data to estimate production and
sales. The support document entitled "Economic Impact Analysis" is
the source for the following figures.
The above criteria would eliminate approximately 9.5% of the
companies that manufacture the chemicals subject to this proposal.
Only 10% of the reports that could be submitted by all manufac-
turers for each chemical would be excluded. Given an estimated
average of 5 chemicals per company, companies with sales less than
$30 million could be subject to costs of approximately $2,600.
This cost would only be incurred if production were greater than
100,000 Ibs. for the reportable chemical. The Agency proposes that
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this quantity is significant in its possible exposure implications
and therefore is justified. The savings to small companies amounts
to about $580,000 altogether.
The Agency will consider comments on raising or lowering the
sales or volume cut-offs of the proposed small business exclusion.
One important consideration is that the cost to an individual small
company could be great. This is particularly so with the require-
ment to report if production is greater than 100,000 Ibs., since
many companies that are "small" by virtue of their sales volume are
not small with respect to their production volume. Indeed, as many
as two thirds of the companies with sales under $30 million may not
qualify as small because of the 100,000 Ib. cut-off.
An alternative approach, that would relieve the burden on very
small companies, is to totally exclude any company below a set
sales value, regardless of production volume. Such a standard
would be as:
(1) No company with total business sales below $x must report,
and
(2) No company with total sales between $x and 30 million and
that made less than 100,000 pounds of a reportable chemical
substance at each site must report on that chemical.
If x were equal to $1 million, about 16% of the companies that
manufacture the chemicals subject to this rule would be eliminated,
with a loss of 13% of total possible reports and a savings to small
companies of about $740,000. If x were $3 million, 24% of the
total firms would be eliminated and 16% of the total reports would
be lost and small companies would save about $1,040,000.
This second approach, while affecting a small percentage of
possible reports, could eliminate significant information on uses
peculiar to these smaller companies. The agency requests comments
on whether the volumes and the uses of the chemicals manufactured
by such small companies are apt to differ from those of larger
companies. If a significant number of chemicals are made only by
"small" companies as defined in this proposal it may be necessary
to lower the sales and/or offer volume cut-offs.
The economic impact of this proposal is discussed generally in
the next section of this preamble. The total cost of the rule does
not vary greatly with changes in the sales cut-off since most of
the reports will be completed by larger companies (primarily those
greater than $100 million in sales) and since most of the chemicals
are produced in large quantities.
The small business definition proposed for this rule has a
relatively large sales cut-off of $30 million. This compares with
previous definitions under TSCA rules of $5 million and $1 million
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(Inventory Reporting Regulations, 40 CFR 710.2 (x) , and proposed
Premanufacture Notification Requirements, 44 FR 2277). The Agency
proposes that, since the information is to be gathered for pre-
liminary evaluations, rather than for detailed risk assessments, it
is appropriate to exclude a relatively large portion of smaller
firms. However, in later rules under section 8(a), e.g., the
General and Detailed Assessment Information rules described above,
that will apply to a fewer number of chemicals that are under
scrutiny for possible control regulations, it will be necessary to
obtain as complete a body of information as possible. Therefore,
the definition of "small" will probably have a lower dollar value
for those rules.
The Agency solicits comments on the various approaches to
excluding small businesses from reporting requirements under this
rule. Comments should include data on the impact on small
companies and the likelihood that they have significant information
for the Agency.
8. Economic Impact
A complete analysis of the economic impact of this proposed
rule is included in the public record under the title, "Economic
Impact Analysis". Copies may be requested. This section
summarizes that analysis.
Approximately 1200 companies will be subject to the initial
manufacturer report on the chemicals listed in the proposal. Based
on the average of the number of reports (chemicals) per company and
the small business exclusion discussed above, the total cost of the
initial report would be $6 million. The cost to any one firm is
dependent on the number of listed chemicals it manufactures. This
number ranges from 1 to 300, with the estimated mean at about 5.
Cost estimates are based on a $480 fixed cost per company and $420
variable cost per chemical.
Since the Agency does not know the extent to which manufac-
turers will be able to supply customer information, it is difficult
to estimate the total cost of subsequent reporting by customers.
The cost to a customer for filling in information for part B of the
form should be much less than the cost of the manufacturer report
since less information is involved (approximately $210 per pro-
cessor) . If the Agency follows up on 50 to 100 manufacturers, with
10 customers per manufacturer, the cost of customer follow-up would
be about $105,000 to $210,000.
These costs could change significantly if comments to this
notice result in changes for the final rule. If the accuracy
required in reporting is increased or the kinds of companies that
must report are expanded, the cost of the final rule could be much
higher. For example:
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(1) If the accuracy of reporting is changed to requiring two
significant figures for manufacturer reports, the variable cost of
filling in the form for one chemical could change from $420 to
$1020.
(2) If persons who manufacture the chemical as a byproduct or
impurity are included, the number of respondents would increase
greatly. This would be affected by any applicable minimum volume
cut-off. The larger the cut-off, the fewer the number of
respondents.
(3) If processors were included in the initial report, the
number of persons subject to the rule would increase at least
10-fold as there are at least 10 processors per chemical and
probably more for the high volume chemicals; the cost would also
increase significantly.
The Agency solicits comments on the economic impact of the
proposed rule and on the impact of any of the alternatives
mentioned in this preamble
It is proposed to revise Part 712 of Chapter I of Title 40 as
follows:
PART 712-GENERAL RECORDKEEPING AMD REPORTING RULES
Subpart A — General
Sec. 712.1-712.9 [Reserved]
..*' o .
Subpart B — Preliminary Assessment Information
712.11 Scope and compliance.
712.12 Definitions.
712.13 Who must report.
712.14 Initial submission of forms: What
must.,be reported.
712.15 Customer lists.
712.16 Confidentiality claims.
712.17 Reports by customers.
712.18 Chemical substances.
Appendix I: Form No. 7710-35, Preliminary
Assessment Information Report; Instructions.
Appendix II: Substantiating Confidentiality
Claims.
Authority: Section 8(a), Toxic Substances
Control Act, Pub. L. 94-469 (90 Stat. 2003, 15
U.S.C. 2601 et. seq.).
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§ 712.11 Scope and compliance.
(a) Under the general recordkeeping and reporting authority of
section 8(a) of the Toxic Substances Control Act (TSCA), 15 U.S.C.
2607(a), this rule requires manufacturers of selected chemical
substances to report production, use, and exposure information on
listed chemical substances. These manufacturers are requested to
report information on their own and customers' activities.
Customers of the manufacturers of the selected substances may be
required to report subsequently. These subsequent reports will be
required when the manufacturers' responses are incomplete as to
customers' activities.
(b) Subsection 15(3) of TSCA makes it unlawful for any person
to fail or refuse to submit information required under this rule.
Section 16 provides that a violation of section 15 renders a person
liable to the United States for a civil penalty and possible
criminal prosecution. Under section 17, the district courts of the
United States have jurisdiction to restrain any violation of
section 15.
§ 712.12 Definitions.
The definitions in section 3 of TSCA, 15 U.S.C. section 2602,
apply for this rule. In addition, the following terms are defined:
(a) "Byproduct" means any chemical substance or mixture
produced solely without separate commercial intent during the
manufacture, processing, use, or disposal of another chemical
substance(s) or mixture
(g) "Intermediate" means any chemical substance which is
consumed, in whole or in part, in chemical reaction (s) used for the
intentional manufacture of other chemical substances or mixture(s),
or is intentionally present for the purpose of altering the rate of
such chemical reaction(s).
(h) "Manufacture for commercial purposes" means to import,
produce, or manufacture with the purpose of obtaining an immediate
or eventual commercial advantage for the manufacturer and
include(s), among other things, such "manufacture" of any amount of
a chemical substance or mixture,
(1) For commercial distribution, including for test marketing,
and
(2) For use by the manufacturer, including use for product
research and development, or as an intermediate.
Manufacture for commercial purposes also applies to substances that
are produced coincidentally during the manufacture, processing,
use, or disposal of another substance or mixture, including both
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byproducts that are separated from that other substance or mixture
and impurities that remain in that substance or mixture. Such
byproducts and impurities may, or may not, in themselves have
commercial value. They are nonetheless produced for the purpose of
obtaining a commercial advantage since they are part of the
manufacture of a chemical product for a commercial purpose.
(i) "Mixture" means any combination of two or more chemical
substances if the combination does not occur in nature and is not,
in whole or in part, the result of a chemical reaction; except that
"mixture" does include (1) any combination which occurs, in whole
or in part, as a result of a chemical reaction if the combination
could have been manufactured for commercial purposes without a
chemical reaction at the time the chemical substances comprising
the combination were combined, and if all of the chemical
substances comprising the combination are included in the EPA
Chemical Substances Inventory after the effective date of the
premanufacture notification requirement under 40 CFR 720, and (2)
hydrates of a chemical substance or hydrated ions formed by
association of a chemical substance with water. The term mixture
includes alloys, inorganic glasses, ceramics, frits, and cements,
including Portland cement.
(j) "Non-isolated intermediate" means any intermediate that is
not intentionally removed from the equipment in which it is
manufactured, including the reaction vessel in which it is
manufactured, equipment which is ancillary to the reaction vessel,
and any equipment through which the substance passes during a
continuous flow process, but not including tanks or other vessels
in which the substance is stored after its manufacture. ......
(m) "Process for commercial purposes" means the preparation of
a chemical substance or mixture, after its manufacture, for
distribution in commerce with the purpose of obtaining an immediate
or eventual commercial advantage for the processor. Processing of
any amount of a chemical substance or mixture is included. If a
chemical or mixture containing impurities is processed for
commercial purposes, then those impurities are also processed for
commercial purposes
§ 712.13 Who must report
(b) Subsequent reports by customers.
Except as provided in paragraph (d) of this section, persons who
processed or manufactured chemical substances for commercial
purposes during the year(s) specified in § 712.18 are subject to §
712.17.
(c) The following persons are not subject to § § 712.14 and
712.15:
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(1) Persons who manufactured or imported the chemical
substance solely for purposes of scientific experimentation,
analysis or research, including research or analysis for product
deve1opment.
(2) Persons who imported the chemical substance as:
(i) An impurity or
(ii) A component of an article.
(3) Persons who manufactured the chemical substance as:
(i) A byproduct that was not used or sold or that was formed
as described in 40 CFR 710.4(d)(3)-(7);
(ii) A non-isolated intermediate; or
(iii) An impurity.
(4) Persons who imported a mixture containing the substance.
(5) Persons who only processed the chemical substance during
the calendar year specified in § 712.18.
(d) Except as provided in paragraph (d) (2) of this section,
small manufacturers and processors are not subject to this rule.
(1) To qualify as a small manufacturer or processor a person
must meet both of the following criteria:
(i) Total annual sales of all sites owned or controlled by the
parent company were less than $30,000,000, based upon the
manufacturer's or processor's latest complete fiscal year as of
January l, 1979.
(ii) The annual production (or amount processed) of the
chemical substance listed in § 712.18 was less than 100,000 pounds
(45,400 kilograms) during the year specified in § 712.18. This
criterion applies to any plant site owned or controlled by the
parent company.
(2) Small manufacturers and processors will be subject to this
rule if the chemical substance they manufacture or process is
subject to a rule proposed or promulgated under TSCA sections 4,
5(b)(4), or 6 of TSCA, 15 U.S.C. sections 2603, 2604(b)(4), or
2605, or an order in effect under section 5(e) of TSCA, 15 U.S.C.
section 2604(e), or the subject of relief that has been granted
under a civil action brought under section 5 or 7 of TSCA, 15
U.S.C. sections 2604 or 2606.
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§ 712.14 Initial submission of forms: what must be reported.
(e) Generally, persons must report information that is known
to or reasonably ascertainable by them for rules under TSCA section
8 (a). For purposes of this rule, however, a less burdensome
standard shall apply. Companies shall report information that is
readily obtainable by management and supervisory employees
responsible for manufacturing, processing, distribution, technical
services, and marketing. Extensive file searches are not required.
• * • • •
§ 712.15 Customer lists.
(a) All manufacturers and importers who are required to report
under § 713.13(a) must maintain records of the customers who
received the quantities of chemical substances reported on Form No.
7710-35 for a period of two years after the effective date of the
addition of the substance to § 712.18. These records must contain
the name, address, technical contact, phone number, and the
quantity sent for each customer, and report number of the form
filed.
(b) In the case of chemical substances listed in § 712.18(3),
if the Deputy Assistant Administrator of the Office of Program
Integration and Information, Office of Pesticides and Toxic
Substances, determines customer information is needed, he/she will
require, by certified letter, a list of customers to be submitted.
Submission of customer lists will be required only when significant
quantities for customer activities have been reported as unknown in
the initial reports under section 712.14, such that the amount of
this unknown information makes it impracticable to complete an
evaluation of the substance, and when the toxicity of the chemical
is either significant or unknown.
(1) The list required under this paragraph shall be submitted
within 30 days of receipt of the certified letter. This list must
contain each customer's name, address, phone number, technical
contact, and quantity sent, for all quantities for which the use
and/or process type was reported as unknown. If the customer is a
person who only distributes the substance in commerce, this should
be noted. The list must also reference the report number of the
form filed.
(2) Letter requests shall be sent under this paragraph no
later than two years after the effective date of the addition of a
chemical substance to § 712.18(a).
(c) In the case of chemical substances listed in § 712.18(b),
persons who manufactured or imported the substances must submit a
list of all customers, including name, address, technical contact,
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phone number, and quantity received when they submit Form No.
7710-35 for those substances.
(1) The list required under this paragraph shall be postmarked
within 60 days after the chemical substance has been listed in §
712.18(b).
S 712.17 Reports by customers.
(a) If a list of customers is obtained under § 712.15, the
Deputy Assistant Administrator of the Office of Program Integration
and Information, Office of Pesticides and Toxic Substances will
contact those customers by certified letter and require them to
supply the information for Part B of Form No. 7710-35, with
respect to their own activities.
(b) Only persons who process or manufacture the chemical
substance for commercial purposes and who are not "small" as
defined by § 712.13(d) must report.
(c) The same standards of accuracy as required of
manufacturers and importers in § 712.14 (e) and (f) apply to
reports by customers
Appendix I - Preliminary Assessment Information Report Instructions
for Filling Out the Form
Form Parts A and B, General Instructions
Questions 1, 2, 3, and 5-12 refer to the total quantity of a
chemical substance manufactured, imported, or processed by a firm
at all of its plant sites LESS the quantity that is not regulable
under the Toxic Substances Control Act. Total quantity
manufactured is to be reported in number 4, regardless of ultimate
use.
Quantities are to be reported in KILOGRAMS (1 kilogram = 2.2
pounds). Values given must be at least accurate to -within +/-
50%. If the uncertainty in the number is greater than that, answer
"unknown".
Part A: Manufacturer's Activities
3. Report the net quantity that is made but NOT recovered
because it is lost to the environment or remains in process wastes
or otherwise is not collected. If possible, fill in the quantities
lost in the following three ways. If this information is not known
within the required accuracy enter "Unknown".
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3a. Lost to the Environment During Production, Use, Storage,
and Transfer —
including intentional or accidental venting, spills, evaporation,
leaks and other fugitive emissions, dust dispersal, effluents and
stack emissions to the air, land or water.
3b. Process Wastes Treated to Destroy the Chemical
including incineration, chemical reaction, or other means to
destroy the chemical.
3c. Process Wastes Where Chemical is Not Destroyed —
including any landfill, surface impoundment, municipal sewage, or
storage.
Questions 4, 5, and 6
Process Categories
Questions 4, 5 and 6 concern handling of the chemical in the
manufacturer's workplace. You are to specify how many workers are
involved with how much of the chemical, and the duration of their
involvement. The term "workers" for these questions includes not
only those directly involved in manufacturing, but also those
involved with equipment inspection and maintenance, transportation
and distribution, and clean-up. Average figures may be used based
on actual practice for the reportable year.
You must also specify what type of process was used in handling the
chemical. Three general process types are given:
Enclosed Process means the entire process is designed so that
there are no intentional releases of the chemical. Only fugitive
or inadvertent release occurs and special measures are taken to
prevent worker exposure and environmental contamination.
Controlled .Release Process means the main production process
is designed and operated so that deliberate or planned release of
the chemical is permitted within prescribed limits. These limits
will be dictated either by company guidelines or imposed by
government regulations. Count workers who are only involved in
controlled release processes; if they work where parts of the
process are enclosed and other parts have controlled release,
report quantities and workers under "Controlled Release".
Open Process means the chemical is routinely in direct contact
with the atmosphere and no measures are taken to prevent
environmental release; e.g., reaction vessels are open, or the
chemical is transported or stored in open containers. If any part
of the process is open, report quantities and workers under "Open".
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Filling in the Chart
Fill in the chart for the calendar year specified in 40 CFR
712.18 for each category. Enter the total quantity of the subject
chemical and the total number of workers involved. Count only
those workers involved with processes where the chemical is
present.
Columns A and B require the calculation of worker involvement
according to hours/week and the number of weeks/year they are
involved with the chemical. Column A is for those workers
averaging 10 or less hours per week involvement. Column B is
calculated in the same way as column A except that it is for those
workers involved with the chemical for more than 10 hours per week.
To Calculate
The figure to be entered in column A or B for each process
category is to be calculated as in the following example. If 5
workers are involved with a chemical each for twenty weeks and 10
workers are involved each for 1/2 week, calculate:
5 workers x 20 weeks =100
10 workers x 1/2 week = 5
and enter the total 105
4. Fill in the chart for process types used in manufacturing
the chemical. Include the TOTAL quantity of chemical manufactured
whether used in TSCA regulated products or not. Count the number
of workers directly involved in manufacture, equipment inspection
and maintenance, quality control, and cleaning.
5. Fill in the chart for use of the chemical at your plant
sites as a reactant or intermediate where the molecular structure
of the chemical is altered by breaking a chemical bond(s) or making
new chemical bonds between the original substance and some other
substances. Count the number of workers directly involved in the
process using the chemical, plus inspection and maintenance
workers.
6. Fill in the chart for use of the chemical at your plant
sites, other than as a reactant, for uses regulable under TSCA. A
chemical is considered to be a non-reactant if its molecular
structure is maintained throughout the normal course of its use.
The chemical may undergo physical changes (e.g., changes in state
or density, physical mixing with other substances) as long as no
chemical changes occur. Examples include solvents, dielectric
fluids, emulsifiers, and lubricants. List catalysts under this
category. Include in this chart the number of workers processing
the chemical, if separate from its manufacture; this includes
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producing products containing the chemical, preparing the chemical
for distribution to customers, packaging, labeling, and trans-
porting products containing the chemical.
7. Specify the quantity of the chemical substance you put in
consumer products. For purposes of filling out this form only,
"consumer products" is defined as in the Consumer Product Safety
Act, 15 U.S.C. 2052 section 3(a)(l). Three consumer product types
are given:
Articles With No Release are articles constructed in a way to
prevent human exposure or release to the environment of the
chemical substance during normal use and storage; e.g., chemicals
in thermometers, in internal components, and in components inside
sealed articles.
Articles With Some Release are articles whose material
components are made of chemicals which come in direct contact with
persons using the article, the atmosphere, land or water; i.e.,
exposure can come from leaching, evaporation, or surface contact.
This includes such articles as plastic containers, chemically
treated textiles, printed paper, coated appliances, etc. If the
chemical itself is sold in a bottle or other container it should be
reported under "Chemical Substance or Mixture," not as an article.
Only the container itself is an article for purposes of this form.
Chemical Substance or Mixture is for use directly by the
consumer, e.g., as cleansers, paints, inks, deodorizers and other
formulations containing the chemical.
8. Specify the quantity of the chemical substance you sell to
persons who are distributors only of the substance. If the
chemical is used or processed in any way report this under Part B.
Part B: Use of the Chemical by others
This part of the form applies to use of the chemical by your
industrial customers either to make consumer products or industrial
products. The category "unknown" is provided when either (1) the
respondent does not know or cannot reasonably ascertain the answer
within the accuracy required, or (2) the respondent knows the
answer only because he has promised his customer that he will not
reveal it further.
9. Specify the total quantity distributed to customers. As
possible, fill in the chart provided for the uses and process types
applicable to those customers.
10. Specify the quantity of chemical substance manufactured by
you that is used by your customers to make consumer products. If
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you know some quantity is used in consumer products but cannot make
a reasonable estimate, mark Unknown".
11. If a quantity is reported in number 10, separate the total
into one or more of the types of products listed
APPENDIX II — Instructions For Asserting and Substantiating Claims
of Confidentiality
J. Categories of Claims
EPA had identified five categories of information into which
most confidentiality claims will fall:
1. Manufacturer's (Importer's) Identity
2. Specific Chemical Identity
3. Production Volume
4. Uses of the Chemical Substance
5. Process Information .....
TJJ. Substantiating Claims of Confidentiality
In addition to asserting a claim as explained in section I and
II of the instructions, form submitters must do the following to
substantiate claims of confidentiality for information on the form.
C. Specific Questions. — In addition to the certification,
you must answer the following questions if you claim information
confidential in these categories. (Note: for each category, you
must answer the questions only once, regardless of the number of
times you claim information confidential in that category.)
Process Information
1. If you have claimed confidentiality for manufacturer's
identity and EPA keeps confidential the link between your company
identity and process information, your identity will not be
associated in any way with this information. In this case, what
harm to your competitive position would result from disclosing the
process information? What is the causal relationship between the
disclosure and the harmful effects?
2. If you have claimed confidentiality for chemical identity
so that the chemical identity category is not associated in any way
with the process information, what harm to your competitive
position would result from disclosing the process information? How
could a competitor use this information? What is the causal
relationship between the disclosure and the harm?
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FINAL RULE
Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982
/ Rules and Regulations / Starting Page 26992
40 CFR Part 712
[OPTS-82004F; FRL 2039-7]
Chemical Information Rules;
Manufacturers Reporting; Preliminary
Assessment Information
ACTION: Final rule.
SUMMARY: This final Preliminary Assessment Information rule
requires chemical manufacturers (including certain producers and
importers) to submit information on approximately 250 chemicals.
The information sought from manufacturers includes data on the
quantities of chemicals manufactured, the amounts directed to
certain classes of uses, and the potential exposures and
environmental releases associated with the manufacturer's own and
his immediate customers' processing of the chemicals. The
information collected under this rule will answer a critical need
for basic data that can be used in setting priorities for testing
chemicals and for assessing risks associated with chemicals.
EFFECTIVE DATE: This regulation becomes effective on July 22, 1982.
SUPPLEMENTARY INFORMATION:
I. Introduction
Proposed amendments to this final rule are published elsewhere
in this issue of the Federal Register.
EPA proposed a rule under section 8(a) of the Toxic Substances
Control Act (TSCA) to obtain general use and exposure data on 2,226
chemical substances published in the Federal Register of February
29, 1980 (45 FR 13646). More than 150 written comments were
received on the proposal and several meetings were held with
members of the public. The Agency also received a petition from
the Chemical Manufacturers Association requesting that the Agency
provide dossiers and other information on the 2,226 chemicals for
purposes of public comment. EPA responded to the petition in the
Federal Register of April 28, 1980 (45 FR 28173). This preamble
explains the final rule's provisions and addresses by topic the
changes EPA has made to simplify, clarify, and reduce the burden of
the rule
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After considering comments, the Agency has changed certain
provisions and significantly reduced the number of chemicals. The
changes to the provisions will reduce the burden of reporting
without greatly decreasing the value of the information that the
rule will collect on each chemical. Also in response to comments,
the Agency has added explanatory material to clarify the
requirements. Because of these changes, the Agency has changed the
format of the final rule. The rule is now arranged in three
Subparts. Subpart A contains general provisions applicable to the
entire Part. Subpart B contains reporting requirements for
chemical manufacturers. Subpart C will contain the chemical
processors' reporting requirements proposed separately today. This
arrangement should allow manufacturers and processors to more
easily identify the provisions to which they are subject.
Elsewhere in this issue of the Federal Register, EPA is
proposing three amendments to this final rule. One amendment is
the plan for follow-up reporting by processors. Another change
would require reporting automatically within 60 days on chemicals
recommended for testing under section 4 of TSCA by the Interagency
Testing Committee (ITC). The third change would make about 50
additional ITC-recommended chemicals subject to reporting under
this rule
A. Rule Design: Two Part Reporting
The final rule anticipates two rounds of reporting. In the
first round, manufacturers of chemicals listed in § 712.30 of the
rule must submit Preliminary Assessment Information Manufacturer's
Reports. The reports must be submitted to EPA within four months
of the effective date of the rule.
The manufacturer's report includes items on the use of a
manufacturer's chemical by his customers, when the customers are
also processors of the chemical. However, manufacturers may report
"unknown" for their processor-customers' uses either when
manufacturers do not know the customers' uses to within +/- 50
percent accuracy, or when the information is subject to a secrecy
agreement between the manufacturer and customer.
The Agency will aggregate the customer use data for each
chemical. If manufacturers report customer uses unknown for over
20 percent of the total amount of a chemical manufactured and
imported, the Agency plans to initiate a second round of reporting,
this time by processors, in order to complete its assessments. As
noted above, the procedures for this second round of reporting are
proposed for comment in a separate notice today
II. Who Must Report
A. Persons Included
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l. Manufacturers. The term "manufacture" under TSCA includes
importing and producing as well as manufacturing activities.
Persons must report on each listed chemical substance that they
manufactured for commercial purposes in the reporting period
specified for the chemical. Discussion of the application of this
rule to producers and importers follows.
2. Producers — Miners and oil refiners. Questions were asked
during the comment period about the application of this rule to
mining of chemical substances. The concern was that listed chemical
substances are present in mined substances in variable or undefined
concentrations and that a single chemical substance may be reported
as "manufactured" more than once in the stream of commerce.
Commenters felt that it must be made clear precisely at what point
they are "manufacturing" a specific chemical substance that is
present in a mined substance. We have provided clarification both
here and in the rule.
Any method of extraction, refinement, or purification of the
mined substance to make it marketable as a listed chemical sub-
stance is to be regarded as "manufacture of a listed chemical
substance" for the purposes of this rule. An undefined or variable
concentration mixture not intended for marketing as a listed
chemical is not subject to this rule.
In general terms, mining can be regarded as extracting a
substance from the atmosphere, earth, or sea. The most common
methods are digging ores and drilling oil. Many persons mine
complex substances containing listed chemicals in undefined or
variable concentrations, but do not refine the mined substance in
order to extract a particular chemical substance for use or sale.
Some of the chemicals subject to this rule may be present in and
produced from these complex precursor substances. However, because
EPA has excluded undefined, variable composition substances from
the list of chemicals subject to this rule, production or mining of
the undefined, variable composition precursor is not to be
reported. Only subsequent steps devoted to production of the
listed chemical are reportable.
For example, persons who manufacture a chemical substance such
as "sweetened naphtha, 64741-87-3," but do not refine the naphtha
to produce "hexane, 110-54-3" would not report on hexane. Only the
production of "hexane" as an isolated product must be reported —
not previous production of more crude, complex substances such as
the naphtha from which hexane is extracted
B. Exemptions From Reporting
Most of the comments supported the exemptions to reporting in
the proposed rule. The proposed exemptions have been adopted. In
addition, the final rule contains an exemption suggested by
commenters to exclude reporting on the manufacture of less than 500
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kilograms annually at a plant site. The Agency estimates that this
exemption will exclude about 170 reports. Excluding reports of
these small production quantities will not affect assessment of the
chemicals and so will relieve an unnecessary reporting burden.
III. Reporting Form for Manufacturers
A facsimile of the Manufacturer's Report — Preliminary
Assessment Information form appears in § 712.28. The data
reporting section of the form (Section IV) has two parts: Part A:
Plant Site Activities and Part B: Chemical Substance Processing by
Customers. Production, processing, and use at each single domestic
manufacturing site must be reported on Part A, including the number
of workers, uses, and process types employed, and quantities of the
chemical that are or are not recovered. Part B of the form applies
to the processing of the chemical by others. Part B will account
for the quantity of chemical that is distributed from the manu-
facturing plant site. Altogether, the form identifies where a
chemical is made and in what quantities, how many workers are
potentially exposed during manufacture, processing, and use at the
manufacturing plant site, what likely environmental releases exist,
and what quantities are used in various categories of uses both by
the manufacturer and as the chemical moves into commerce.
In Part A, items 1 and 2 ask for total quantities of the
chemical imported and domestically manufactured. Item 3 covers
quantities lost during manufacture. Items 4, 5, 6, and 7 ask for
quantities, worker-hours, and number of workers associated with
enclosed, controlled release, and open process categories. Item 4
covers manufacture of the chemical; item 5 covers on-site use as a
reactant; item 6 covers on-site non-reactant use; and item 7 covers
on-site preparation of products. Item 8 asks how much of the
chemical the manufacturer makes into products to be used by
industry or by consumers; these products include the chemical
itself and mixtures containing the chemical, articles with some
release of the chemical possible, and articles with no release.
All of the above Part A items concern the manufacturer's own
activities and use of his own products.
Part B concerns the activities of the manufacturer's immediate
customers (processors) . Item 9 parallels item 8 of Part A; it asks
how much of the chemical the customer makes into products to be
used by industry or by consumers in various forms. Item 10 asks
for the trade name(s) under which the manufacturer markets the
chemical to his customers. This item is only to be answered if the
manufacturer reports that his customers' uses are unknown for more
than 20 percent of the quantity of chemical manufactured and
imported. Item 11 asks the manufacturer to estimate, based upon
his general knowledge of industry practices, the quantity of the
chemical that is processed by his customers in enclosed,
controlled, or open processes, respectively.
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A. Readily Obtainable Data
The rule requires persons to report data that are readily
obtainable by management and supervisory employees responsible for
manufacturing, processing, distribution, technical services,
marketing, and other related activities. These knowledgeable
people are responsible for providing estimates and associated
accuracy levels for the data elements on the form. The comments
supported this standard.
B. Accuracy for Reporting
For Part B of the form, dealing with processor-customers'
activities, quantities must be reported within +/- 50 percent.
We are persuaded that manufacturers must routinely know their
own production efficiencies and quantities in order to control
their costs and price their products. Thus, when manufacturers
report about their own activities, the best estimate from readily
obtainable data would be sufficiently accurate. There is no need
for the company to expend further effort to report more exactly.
For example, it will be legitimate for a company to report figures
based on design capabilities of a process. Thus if a process is
planned to utilize or produce a certain quantity per "run" or per
unit time, or is planned to produce a certain quantity of product
from a defined quantity of feedstock material, then the company may
assume that the design quantities are the actual quantities, and
not attempt to account for variations.
Most of the companies who commented favored the broadest
possible limits on accuracy of quantities reported. Except for the
questions relating to losses during manufacture and customer
activities, companies simply endorsed broad limits without
discussion. They cited no specific difficulties in reporting on
quantities going into and coming out of their own production
processes. One commenter in fact said, "If we do it, we know it."
The Agency has concluded that reporting on the basis of readily
obtainable data will not impose significant burdens
Items 3a, 3b, 3c, and 3d deal with losses during manufacture
of the chemical. Comments said lack of measured data presented a
serious difficulty in meeting the proposed level of accuracy for
quantities reported on question 3a. For the final rule, manu-
facturers may calculate the total loss for question 3a by finding
the differences between the quantities theoretically manufactured,
and quantities actually used or sold. For items 3b, 3c, and 3d, we
have decided to allow respondents to simply tell us the accuracy of
the quantities reported. The following difficulties were cited for
reporting the destiny of losses: many times the amounts lost are
very small, on the order of parts per million, and a 10 percent or
50 percent difference would be insignificant or immeasurable;
routine methods for analyzing emission or effluent amounts do not
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exist in most cases; and in some cases there are multiple sources
of loss that would make calculations extremely difficult. We have
concluded that by allowing companies themselves to specify the
accuracy of the figures, based on readily obtainable data, we will
receive the estimates we need, without imposing unnecessary
burdens. Companies are not required to conduct monitoring to
comply with this rule; they may answer this item by mass balance
estimates.
The accuracy of reporting customer activities under item 9 of
the proposed form received the greatest attention from conunenters.
Most commenters felt that quantities of a chemical processed by
individual customers in enclosed, open, or controlled release
operations would be beyond their knowledge in most cases. Further-
more, the proposed item 9 asked for quantities of chemicals by
customer use and process category in a combined matrix. This
simultaneous accounting for quantities would have required a
customer-by-customer accounting, followed by sorting and aggre-
gating quantities into 16 matrix boxes. In the view of most
companies, this complicated accounting together with their lack of
knowledge of customer processes would have resulted in frequent
reporting of quantities as "unknown."
We have changed the reporting of customer activities in
response to difficulties described in comments. The final form has
two items, 9 and 11, to cover customer activities. Item 9 now asks
for quantities by customer use within +/- 50 percent accuracy.
Commenters indicated that this could be done. Where respondents
cannot report within +/- 50 percent, or where they have a secrecy
agreement with the customer, they may report "unknown." Item 11 now
asks for the respondent's estimate of the kinds of processes
generally used for the chemical.
In general, manufacturers should report information on their
customers' uses to the extent that this information is known.
Manufacturers are not required to obtain additional information
from customers for this rule.
C. Reporting Worker-Hours, Number of Workers, and Quantities:
Items 4-7
As a result of comments, EPA has simplified reporting of
worker-hours, number of workers, and quantities by process category
under items 4-7. Only the workers directly assigned to the
manufacturing, processing, and use of the chemical should be
counted. Maintenance workers should be counted only if they are
directly assigned to and are a regular part of a process.
When answering the items on worker-hours or number of workers,
respondents must (i) identify the process category (enclosed,
controlled release, or open) with which the worker spends the most
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time, and (ii) determine the number of workers involved with a
given process category. For multiprocess operations, workers
operating more than one process category should be listed only once
— under the process category with which they work most of the
time. This should avoid double counting of workers.
Worker-hours need not be calculated from detailed production
records, but may be based on design factors. That is, worker-
hours may be estimated from the plant's production of a given
chemical and the design number of employees needed to achieve that
production.
The final rule simplifies reporting by requiring the total
number of workers involved in each process category, and deleting
the proposed distinction between full and part-time workers. The
number of workers should include employee turnover, and will not
necessarily correspond to worker-hours. Include all employees who
work on a given chemical's production or processing, regardless of
the length of time of employment.
Instructions have been clarified regarding items on the
quantity of a chemical that goes through each process category.
Chemical production could involve a single process or a multi-
process operation, a split stream involving different processes, or
two separate streams involving different processes (e.g., one
stream might be for a reagent grade chemical and another for a
technical grade). The instructions discuss how to handle reporting
in these differing circumstances.
D. Preparation and Uses of Manufacturer's Products: Items 7 and 8
The form has been revised to identify more clearly the
distinct activity of on-site product preparation (making a product
containing the manufactured chemical). Item 7 in the final rule
applies only to plant sites that both manufacture and process a
chemical. If a manufacturer of a listed chemical also produces a
formulated mixture or other industrial or consumer product
containing the chemical, he must report the chemical quantities,
number of workers, and process categories in this question.
Item 8 asks for the quantities of the substance incorporated
into various use categories of products produced by the manufac-
turer at the reporting site. This item also incorporates proposed
question 12 on export of the chemical substance (as the chemical or
as part of a product).
Commenters thought we should differentiate between institu-
tional and industrial uses to better judge exposures. We do not
believe that this degree of differentiation will contribute to the
evaluation of a chemical without more information on the manner of
use of the chemical. Therefore, for the purposes of this rule,
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"industrial" and "institutional" products are treated in the same
manner.
Commenters said the definition of consumer products should
have the same exemptions as listed in the Consumer Product Safety
Act (15 U.S.C. 2052 (a) (1) (D) ) (CPSA) . We have not adopted this
suggestion. Our purpose in citing CPSA is simply to help
differentiate between consumer and industrial products. Thus, the
CPSA definition, without its exemptions, is included in the rule to
guide manufacturers in categorizing their products.
F. Customer Uses: Items 9, 10, and 11
Items 9 and 11 ask the manufacturer to estimate the quantities
of the chemical that his customers incorporated into various
categories of products, exported, consumed as reactant, and
processed by various categories of process. The manufacturer is to
base his estimates on his knowledge of the market for the products
and his customers' roles in that market.
If manufacturers do not know how all quantities of the
marketed chemical are used by customers, or if a use is subject to
a secrecy agreement with the customer, the amount may be reported
as "unknown". If the manufacturer reports that more than 20 per-
cent of the total quantity manufactured and imported has unknown
uses, in question 10 he must provide the trade names under which he
marketed the "unknown" amount. The Agency, as discussed below,
will use the trade names for processor reporting, if it becomes
necessary for that chemical.
G. Follow-up Reporting
Nearly every industry comment requested that EPA eliminate the
proposed requirement to submit customer lists for purposes of
follow-up reporting on customer data that are unknown to manu-
facturers. Commenters cited several difficulties with the
approach, including their own confidentiality concerns and the
burden of making up the lists when there are many customers. In
addition, some pointed to the potential burden for all concerned,
including EPA, of having follow-up proceed by mailing of letters
back and forth. This would be difficult, especially when manu-
facturers have customer addresses for deliveries rather than
addresses for technical contacts.
The Agency sees merit in many of the comments on the proposed
approach and is proposing a different one in a separate proposed
rule elsewhere in this issue of the Federal Register. The separate
notice describes the new proposal and discusses the comments
already received on processor reporting. In general, under the new
approach, the Agency would aggregate the manufacturers' reports on
a chemical. If "unknown" uses are reported for more than 20
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percent of the aggregate quantity manufactured and imported, the
chemical will be the subject of follow-up reporting by processors.
The market names for the chemical will be taken from the responses
to question 10 of the manufacturers' reporting forms. These names
will be published, and processors of the chemicals under these
names will report about them. This approach is based on commenters'
suggestions that EPA should specify criteria that would trigger
follow-up reporting, and that EPA should publish trade names on
which processors must report in order to protect confidentiality of
chemical product composition
K. Recordkeeping
Commenters expressed concern over the proposed requirement to
maintain records that support information submitted to EPA. The
proposed five-year retention period was said to be too long and too
burdensome. The Agency agrees that this provision should be
deleted. The records supporting reporting under this rule will be
records that companies will retain as a matter of business.
Companies should be alert to the possibility that they may be
required to report under this rule in the future and consider or,
if necessary, reconsider their recordkeeping practices in that
light
V. Other Issues
A. Small Manufacturers
Section 8(a)(3) of TSCA requires the Administrator to consult
with the Small Business Administration and then to prescribe, by
rule, standards to determine who may qualify as a small manufac-
turer or processor. Such small businesses are then exempt from
section 8(a) rule requirements. However, if a chemical substance
is subject to certain proposed or final actions by the Agency, EPA
need not apply the section 8 exemption for small businesses manu-
facturing or processing the chemical. Among the actions that could
remove the small business exemption are proposed rules under
section 4, 5, or 6 of TSCA. Although several chemicals in the list
published today are subject to section 4 proposals, EPA has decided
not to require any reporting by small businesses. The additional
data from those companies would not significantly influence the
overall preliminary assessments.
For this rule, for a plant site to qualify as small with
respect to a listed chemical, a manufacturer or importer must meet
both of the following criteria:
i. Total annual sales taken together of all sites owned or
controlled by the foreign or domestic parent company were below $30
million for the reporting period.
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As chemicals become subject to this rule in the future, the
Agency will consider the need to adjust this dollar figure to
reflect inflation. Sales figures would be based on activities at
all of the plant sites of the reporting firm, its parent, and all
subsidiaries owned or controlled by the parent company. The parent
company owns or controls another company if the parent owns or
controls 50 percent or more of the other company's voting stock, or
other equity rights, or has the power to control the management and
policies of the other company.
ii. Total production of the listed substance for the reporting
year was below 45,400 kilograms (100,000 pounds) at the plant site.
The EPA has consulted with the Small Business Administration
in developing the exemption standard for the rule. The exemption
criteria for this rule have not changed from the proposal, except
for the addition of a factor to correct the sales cutoff for
inflation.
B. Confidentiality
2. Release of data to the public
There are two purposes for releasing data received by the
Agency:
i. To allow the public and the states to conduct local
activities to identify and control risk situations, and
ii. To allow public comment on the aggregate data the Agency
uses to make its decisions.
The first purpose seems best served by the release of discrete
data items that have not been claimed confidential. However,
comments indicated most of the reported data will be legitimately
claimed to be confidential business information. Therefore, the
public would be likely to receive only incomplete data that had not
been claimed confidential. Moreover, the release of discrete
non-confidential data elements would limit the release of the
aggregate data used in risk assessments; discrete non-confidential
data could be subtracted from the aggregate to reveal secret data.
Given these considerations, we have decided to release the
following types of non-confidential data:
i. Identification of a firm or plant site that manufactures or
processes a chemical, except when this fact is confidential.
ii. Aggregate data on production, uses, and workers for each
chemical.
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It will be necessary for us to withhold some data that have
not been claimed confidential in order to protect confidential data
within an aggregate. However, the Agency will determine its
aggregation method in a manner that will allow as much data as
possible to be released, but that will not allow confidential
information to be recognized by the public. By releasing aggregate
data we will be able to share information with the public,
including the regulated industry
Therefore, 40 CFR Chapter I is amended by adding a new Part
712 to read as follows:
PART 712 — CHEMICAL INFORMATION RULES
Subpart A — General Provisions
Sec.
712.1 Scope and compliance.
712.3 Definitions.
712.5 Method of identification of substances for reporting
purposes.
712.7 Report of readily obtainable information for Subparts B
and C.
712.15 Confidentiality.
Subpart B — Manufacturers Reporting — Preliminary Assessment
Information
712.20 Manufacturers and importers who must report.
712.25 Exempt manufacturers and importers.
712.28 Form and instructions.
712.30 Chemical lists and reporting periods.
Authority: Sec. 8(a), Toxic Substances Control Act, Pub. L.
94-469 (90 Stat. 2003, 15 U.S.C. 2601 et seq.).
Subpart A — General Provisions
§ 712.1 Scope and compliance.
This Part establishes procedures for chemical manufacturers
and processors to report production, use, and exposure-related
information on listed chemical substances. Subpart A establishes
requirements that apply to all reporting under this Part. Subparts
B and C, respectively, cover manufacturers' and processors'
reporting.
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§ 712.3 Definitions.
The definitions in section 3 of TSCA, 15 U.S.C. 2602, apply
for this Part. In addition, the following definitions apply:
(a) "Byproduct" means any chemical substance or mixture
produced without a separate commercial intent during the
manufacture, processing, use, or disposal of another chemical
substance or mixture
(f) "Intermediate" means any chemical substance that is
consumed, in whole or in part, in chemical reactions used for the
intentional manufacture of other chemical substances or mixtures,
or that is intentionally present for the purpose of altering the
rates of such chemical reactions. (See also paragraph (j) of this
section.)
(h) "Manufacture for commercial purposes" means to import,
produce, or manufacture with the purpose of obtaining an immediate
or eventual commercial advantage for the manufacturer and includes,
among other things, such "manufacture" of any amount of a chemical
substance or mixture:
(1) For commercial distribution, including for test marketing.
(2) For use by the manufacturer, including use for product
research and development, or as an intermediate. Manufacture for
commercial purposes also applies to substances that are produced
coincidentally during the manufacture, processing, use, or disposal
of another substance or mixture, including byproducts and
coproducts that are separated from that other substance or mixture,
and impurities that remain in that substance or mixture.
Byproducts and impurities may not in themselves have commercial
value. They are nonetheless produced for the purpose of obtaining
a commercial advantage since they are part of the manufacture of a
chemical produced for a commercial purpose.
(i) "Mixture" means any combination of two or more chemical
substances if the combination does not occur in nature and is not,
in whole or in part, the result of a chemical reaction; except that
"mixture" does include (A) any combination which occurs, in whole
or in part, as a result of a chemical reaction if the combination
could have been manufactured for commercial purposes without a
chemical reaction at the time the chemical substances comprising
the combination were combined, and if all of the chemical
substances comprising the combination are included in the EPA, TSCA
Chemical Substance Inventory after the effective date of the
premanufacture notification requirement under 40 CFR Part 720, and
(B) hydrates of a chemical substance or hydrated ions formed by
association of a chemical substance with water. The term mixture
includes alloys, inorganic glasses, ceramics, frits, and cements,
including Portland cement.
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(j) "Non-isolated intermediate" means any intermediate that is
not intentionally removed from the equipment in which it is
manufactured, including the reaction vessel in which it is
manufactured, equipment which is ancillary to the reaction vessel,
and any equipment through which the substance passes during a
continuous flow process, but not including tanks or other vessels
in which the substance is stored after its manufacture. (See also
paragraph (f) of this section.)
(m) "Process for commercial purposes" means the preparation of
a chemical substance or mixture, after its manufacture, for
distribution in commerce with the purpose of obtaining an immediate
or eventual commercial advantage for the processor. Processing of
any amount of a chemical substance or mixture is included. If a
chemical or mixture containing impurities is processed for
commercial purposes, then those impurities are also processed for
commercial purposes
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INSTRUCTIONS FOR
MANUFACTURER'S REPORT FORM
PRELIMINARY ASSESSMENT INFORMATION
IV. PRELIMINARY ASSESSMENT INFORMATION
TSCA Regulatable Quantities - Except under items 4 and 5, do not
report any quantity of chemical substance that is manufactured or
processed solely for use as: a pesticide; tobacco or any tobacco
product; any source material, special nuclear material, or
byproduct material (as terms are defined in the Atomic Energy Act
of 1954 and regulations issued under such Act); firearms or
ammunition or food, food additives, drug, cosmetic, or device (as
such terms are defined in section 201 of the Federal Food, Drug and
Cosmetic Act). The above are not TSCA regulable.
Some chemical substances are manufactured for both TSCA and
non-TSCA regulable purposes. Thus, under items 4 and 5, include
total production of the chemical stream for both TSCA and non-TSCA
regulable quantities.
PART A: PLANT SITE ACTIVITIES
Item 1 - Enter the total quantity of the chemical substance
imported in bulk during the reporting period. if you import, but
do not further process the imported quantity or manufacture an
additional quantity, answer this item and part B only
Items 4-7 - Items 4-7 in part A require you to describe the
manufacturing process and your use of the chemical in terms of the
number of workers and quantity of substance associated with three
process categories. Three process categories are described below,
followed by instructions for calculating quantities, worker-hours,
and number of workers. Additional instructions concerning items 4
through 7 are also listed.
PROCESS CATEGORIES
Enclosed Process -. The process is designed and operated so that
there is no intentional release of the chemical. In this process
category, only fugitive or inadvertent releases occur and special
measures are taken to prevent worker exposures and environmental
contamination. "Special measures" refer to procedures and
equipment that are monitored and used to prevent worker exposure,
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and scrubbers and other recovery equipment employed to prevent
environmental release. Equipment with emergency pressure relief
venting would be allowed in this category; routine venting would
not. With regard to handling the manufactured chemical, persons
who handle closed packages containing the material would be counted
under "enclosed process." Persons who package or transfer the
unpackaged chemical would be counted in one of the following
categories.
Controlled Release Process - The process is operated in a
controlled manner to minimize release of the chemical into the
workplace. Releases should generally be within prescribed limits.
These limits may be dictated by government regulations or by
company guidelines. If the chemical is vented outside the plant,
the process is a "controlled release" process. Do not count
general space ventilation fans.
Open Process - The chemical is routinely in direct contact with the
atmosphere (workplace or outside the plant) and no measures are
taken to prevent release. For example, reaction vessels are open
vats, the chemical is transported or stored in open containers, or
the chemical is freely vented into the workplace atmosphere.
QUANTITIES
Process Category - Enter the greatest quantity that is processed in
each process category. If there is more than one process stream,
calculate each stream separately and then add the values for each
process category. If a quantity of the chemical passes in series
through an enclosed process and then passes through an open
process, the same quantity would be reported twice, once under each
process category. (The sum of these quantities may be greater than
100% of the total quantity manufactured.)
Example 1 - A company manufactures technical grade chemical x in
four steps.
350,000 kg > 350,000 kg > 350,000 kg > 200,000 kg
Open Enclosed Open Enclosed
The company would report:
Enclosed 350,000 kg
Controlled release 0
Open 350,000 kg
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Example 2 - A company produces the same chemical in a reagent and
technical grade with the following steps.
Technical Grade Process:
350,000 kg > 350,000 kg > 350,000 kg > 200,000 kg
Open Enclosed Open Enclosed
Reagent Grade Process:
650,000 kg > 500,000 kg > 500,000 kg > 400,000 kg
Controlled Controlled Open Open
Release Release
The company would report:
Enclosed 350,000 kg
Controlled release 650,000 kg
Open 850,000 kg
(The open process amount is the total of the maximum guantity in
the open process category from each grade.)
Total Quantity - For items 5, 6, and 7, enter the total quantity
processed in all process categories. (This total may be less than
the sum of the quantities reported in individual process
categories.)
WORKER-HOURS
Worker-hours may be calculated for a given process category by
multiplying the average number of full-time employees needed for
the operation by the number of hours operating annually.
Alternatively, worker-hour information may be taken from
preexisting information sources such as resource planning or budget
figures.
WORKERS
In reporting number of workers for each process category, count the
total number of persons directly involved in manufacturing,
processing, and handling the chemical during the reporting period.
Count maintenance or inspection workers only if they work with the
process on a routine basis. Do not count administrative staff.
Three process categories are described in the form: enclosed,
controlled release-, and open. A worker should be counted as
working with only one process category. If he operates several
process types, count him under the one with which he spends the
most time. If he spends an equal amount of time with several,
count him under the most open process.
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Example 3 - A company manufactured 1,000,000 kg of a chemical
substance in 1980. It manufactured the chemical for all twelve
months of the year and did so in an enclosed process.
In order to run the production line, ten (10). workers were present
working 40 hour weeks; thus over the course of the year 20,800
worker-hours were used to run the production line.
Over the course of the year, twelve (12) different workers worked
on the production of the chemical.
The form would then be filled out as follows:
Process category Quantity (kg) Worker-hours Total workers
Open 000
Controlled release 000
Enclosed 1,000,000 kg 20,800 12
Example 4 - A company manufactured 1,000,000 kg of a chemical
substance in 1980. It manufactured the chemical for the entire
year in a 24 hour/day process consisting of three steps in the
open, controlled release, and open process categories. The
production line was shut down for maintenance for 2 weeks of the
year. The production line had three 8-hour shifts. Each shift in
step 1 required 5 workers, while 7 and 10 workers were needed per
shift in steps 2 and 3, respectively. The total worker-hours
required for each step follows:
(Shifts/day x hours/shift
x workers x days/week x
Process' category weeks/year) Workers-hours
Open (Step 1) (3x8x5x7x 50) 42,000
Controlled (Step 2) (3x8x7 x7x 50) 58,800
Open (Step 3) (3 x 8 x 10 x 7 x 50) 84,000
Analysis of the personnel records showed that a total of 75
individuals worked on the production of the chemical during 1980.
After examining the personnel records, the company was able to fill
in the following table:
Process category Total workers
Open (Step 1) 21
Controlled (Step ) 19
Open (Step 3) 35
75
Note that workers are not double counted or "split" even though
some jobs may require moving from one step of the process to
another step of the same process. An employee working on both step
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1 and step 2 is counted only in step 1 if he/she spends most of his
time at that step. After adding together steps in the same process
category, the company would report as follows:
Process category Quantity (kg) Worker-hours Total workers
Open 1,000,000 126,000 56
Controlled release 1,000,000 58,800 19
Enclosed 000
Item 4 - This item applies to the manufacture of the chemical
substance and includes all steps to ready the chemical for further
processing or use.
Item 5 - This item applies to use of the chemical at your plant
site as a reactant in the manufacture of another chemical
substance, where the molecular structure of the chemical is altered
by breaking chemical bonds or making new chemical bonds between the
original substance and some other substance. Report .on all
processing up to and including the actual reaction step and any
ancillary steps which recycle unreacted chemicals back to the
reactor vessel. Do not report on subsequent activities in this
question.
Item 6 - Report the quantity o the chemical substance that you use
on site. Examples include cleaning solvents, dielectric fluids,
emulsifiers, and lubricants. Do not include any quantity that you
react to make a product.
Item 7 - Report the quantity of the chemical substance that you
process at the manufacturing site into products for on site use or
sale. (Note that this does not include manufacture of the chemical
substance; this is reported in item 4 above.) This item does
include the quantity of chemical substance that you incorporate in
a mixture or article. Report the steps up to and including
incorporation of the chemical into an article; do not include any
further processing of the article.
Item 8 - Report the quantity of the chemical substance that you
prepare for commercial distribution in each of the product types in
8a to 8g. Do not include any quantity of chemical substance that
your customers will further process. This will be reported in item
9.
In items 8a to 8f, report the quantity of the chemical substance in
products that are for domestic use. If you are uncertain about
whether your products are ,for domestic or foreign use, report them
as domestic.
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The products are divided into industrial and consumer products.
"Industrial" means the manufacturing and service industries covered
by the Standard Industrial Codes. Products meant to be used
primarily by the general population are considered to be "consumer"
products. The following definition from the Consumer Product
Safety Act can be used as a guide (15 U.S.C. 2052 (a) (1)): "The term
•consumer product1 means any article, or component part thereof,
produced or distributed (i) for sale to a consumer for use in or
around a permanent or temporary household or residence, a school,
in recreation, or otherwise, or (ii) for the personal use,
consumption or enjoyment of a consumer in or around a permanent or
temporary household or residence, a school, in recreation, or
otherwise." If you are uncertain about whether your products are
industrial or consumer, report them as consumer.
Three types of industrial and consumer product types are described
below.
"Chemical substance or mixture" means a chemical, or mixture
containing the chemical, that is used directly by the persons using
the product, e.g., cleaners, paints, inks, deodorizers, solvents,
etc. This includes chemicals or mixtures in containers or other
articles whose purpose is to release the chemical (e.g., cans of
spray paint, ink pens, and other applicators.)
"Articles or products with no release" are articles constructed to
prevent human exposure to or release to the environment of the
chemical substance during normal use and storage (e.g., chemical
coatings on internal components, and chemicals inside sealed
articles as in thermometers and batteries).
"Articles or products with some release" are articles whose
material components are made of chemicals which come in direct
contact with persons using the article, the atmosphere, land, or
water; e.g., exposure can come from leaching, evaporation, or
surface contact. This includes such articles as plastic
containers, chemically treated textiles, printed paper, coated
appliances, etc. If the chemical itself is sold in a bottle or
other container it should be reported under "Chemical substance or
mixture," not as an article. Only the container itself is an
article for purposes of this form; the substance it contains is not
a component of an article
Item 9 - Estimate the quantity of the chemical substance that your
customers process for each of the uses listed in items 9a to 9h.
(Do not include the quantity of chemical substances that your
customers will use without further processing; that quantity should
be reported in item 8a or 8d.)
For items 9a or 9g, follow the same directions as for items 8a to
8g.
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For item 9h, report the quantity of chemical substance that your
customers will react to make products that do not contain the
chemical substance itself.
For item 9i, report the quantity of chemical substance for which
your customers' uses are unknown.
Report your best estimate for items 9a to 9h within +/- 50%. If
you cannot estimate an item to this degree of accuracy, include the
quantity in item 9i. You may report "unknown" if the data would
reveal information subject to a confidentiality agreement between
you and your customers.
Item 10 - If you report your customers' uses as unknown (item 9i
above) for more than 20% of the total quantity that you manufacture
and import (items 1 and 2 above) list the names under which you
distribute the chemical substance.
This item will allow EPA, if necessary, to find out about chemical
uses you have reported as "unknown" by requiring processors of your
products to report directly to us.
Item 11 - This item addresses your general knowledge of the process
types your customers use to process the chemical. Estimate the
quantity of the chemical that your customers process in each of the
three process categories. Specify "unknown" if you do not know to
within +/- 50%.
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PROPOSED RULE
Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982
/ Proposed Rules / Starting Page 27009
40 CFR Part 712
[OPTS-82004G; 2039-6]
Chemical Information Rules;
Preliminary Assessment Information;
Opportunity for Additional Comment
ACTION: Proposed rule.
SUMMARY: EPA is proposing 50 additional chemicals for manufacturer
reporting of preliminary assessment information. These are
chemicals that the Interagency Testing Committee has designated as
candidates for testing in its fifth through ninth reports. EPA is
also proposing supplementary processor reporting on the 300
chemicals subject to manufacturer reporting, when customer use
information is inadequate. In addition, EPA is proposing that
certain chemicals automatically become subject to manufacturer
reporting.
SUPPLEMENTARY INFORMATION:
I. Introduction
EPA proposed a rule under section 8(a) of the Toxic Substances
Control Act (TSCA) to obtain preliminary use and exposure data on
about 2,300 chemical substances published in the Federal Register
of February 29, 1980 (42 FR 13647). Under the final Manufacturers
Reporting — Preliminary Assessment Information rule published
elsewhere in this issue of the Federal Register, manufacturers must
report on about 250 chemicals.
In the original proposal, chemical manufacturers were to
submit information on their own and their customers' uses of the
chemicals. If manufacturers did not provide the specified
information on their customers' uses, manufacturers were also to
submit lists of their customers so that EPA could contact the
customers directly. The Agency received over 150 written comments
on that proposal, most comments requesting that EPA eliminate the
proposed requirement to submit customer lists While EPA does
not agree with all the reasons presented against the customer list
requirement, the Agency is persuaded that customer list reporting
is not the best approach for this rule. Thus today's final rule
deletes the proposed requirement for manufacturers to submit
customer lists. Instead, the Agency here proposes an alternative
approach to obtain data that manufacturers do not supply on their
customers' uses.
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In this notice, the Agency proposes to initiate a "second
round" of "follow-up" reporting from processors by Federal Register
notice. In this second round of reporting, processors would report
on chemical substances that are marketed by manufacturers who
reported unknown customer uses for more than 20 percent of the
total quantity manufactured and imported. EPA would publish by
Federal Register notice a list of the marketing names of these
chemicals. Processors would then submit the shorter Processor's
Follow-up Report — Preliminary Assessment Information on the
listed chemicals. EPA would use the information reported by
processors to complete assessments of the listed chemicals.
The final manufacturers rule also provides that chemicals in
addition to the original 250 may become subject to manufacturer
reporting after proposal and comment. Additional chemicals would
be subject to processor reporting if manufacturers are unable to
provide sufficient information. This notice proposes and solicits
comment on the addition of about 50 chemicals for manufacturers
reporting. These are chemicals that the Interagency Testing
Committee has designated as candidates for testing in its fifth
through ninth reports
This notice also proposes that manufacturers automatically
report on test candidates designated by ITC in the future. We are
proposing to waive future comment periods for the individual ITC
designates in order to collect needed exposure data in a more
timely fashion.
II. Proposed Processor Reporting Requirements
A. New Approach to Processor Follow-Up
The Agency received many comments objecting to the originally
proposed processor reporting requirements. Those proposed
requirements have been deleted and are replaced by a new approach.
This reproposed processor follow-up approach adopts suggestions
made in comments on the February 29, 1980 proposal. Based on those
comments, the Agency considers that this new approach has
significant advantages over the customer list approach. In this
new approach, EPA would require processor reporting for an
individual chemical only after receipt and review of all manu-
facturers' forms on the chemical.
Commenters requested that EPA specify objective criteria to
trigger processor follow-up, so that only a limited number of
chemicals would be subject to processor reporting. The Chemical
Manufacturers Association (CMA) suggested that the trigger should
depend on the data provided by manufacturers and that EPA should
require processor follow-up reporting if at least 10 million pounds
of a chemical are produced for processing by firms other than the
manufacturer's, and all manufacturers' reports on the chemical fail
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to provide use and exposure information on at least 30 percent of
the portion of the chemical's output that is sold to processors.
Gaps in manufacturers' data should trigger processor
reporting, but the Agency does not consider any single, absolute
quantity of chemical to be an appropriate trigger because a
quantity trigger cannot apply equally to all chemicals. For
example, a million pounds is a very small portion of a chemical
when total production is 20 billion, but a very large portion of a
chemical when total production is 2 million.
EPA has not adopted the 30 percent suggestion because the
Agency considers that the trigger should be based on the quantity
of the total chemical manufactured and imported, rather than on
only the portion processed by customers, as CMA suggested.
EPA proposes to require processor reporting on a chemical when
manufacturers report that customer uses are unknown for more than
20 percent of the total quantity manufactured and imported. That
is, on the Manufacturer's Report form, EPA will compare the total
for all manufacturers in questions 1 and 2 to the total for all
manufacturers in item 9i, "unknown customer uses." If "unknown
customer uses" represent more than 20 percent of the total
domestically available, EPA will initiate processor reporting.
If at least 80 percent of the uses of a chemical are accounted
for, then EPA will not require any processor reporting. Knowing 80
percent, we can project that the remaining 20 percent even if it is
radically different will not significantly affect estimates of
overall exposure for preliminary assessment purposes. For
instance, if the exposure estimate for the known 80 percent were
quantified as two on a scale of ten, and, in an hypothetical
extreme case, the missing 20 percent would have scored an eight,
the missing portion would change the average estimate only to
three. With any known portion less than 80 percent, the confidence
in this kind of projection would be correspondingly less.
Likewise, using a figure greater than 80 percent would increase the
confidence of the projection, but at the cost of an increase in
amount of processor reporting.
Also as recommended by comments, when possible, EPA intends to
publish trade names, rather than CAS numbers or chemical names, of
the chemicals on which processors must report. EPA agrees with
comments that this would better protect confidential information on
composition of marketed chemical products, and that this approach
will also communicate more to processors. Manufacturers should
note, however, that if one manufacturer sells a chemical under a
trade name, and another sells the same chemical under its chemical
name, EPA would potentially be required to publish both the trade
name and the chemical name for any follow-up reporting.
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Comments also indicated that manufacturers would be more
concerned about the confidentiality of ingredients in formulated
mixtures sold under trade names, rather than confidentiality of
chemical substances sold under trade names. Because this rule does
not collect information on mixtures, publishing trade names should
be a less serious confidentiality problem. EPA will publish the
trade names in a Federal Register notice along with the reporting
period for each chemical and the date by which processors must
submit reports to EPA. Note that if a manufacturer did not mark
"unknown" for more than 20 percent of the total quantity processed
(question 9i on the manufacturer's form,, published elsewhere in
this issue of the Federal Register as 40 CFR Part 712, Subpart B),
his trade names would not be published. It may also happen that we
will not follow up on a manufacturer who does not account for 80
percent of his processed quantity. Follow-up wold not be needed if
all other manufacturers' reports for the same substance account for
80 percent of the aggregate production.
The new approach has other advantages. Because direct
processor reporting eliminates the need for manufacturers to
assemble and submit customer lists, this approach would decrease
the manufacturers' reporting burden. Follow-up processor reporting
would reach customers who are processors, and would also reach
processors who purchase chemicals from distributors. It would also
avoid unnecessarily involving distributors who are direct customers
of respondent manufacturers, and who do not further process the
chemicals.
The requirements for processor reporting are described in more
detail at III below and elsewhere in this issue of the Federal
Register, and appear in § 712.40 of the proposed rule. Today's
notice solicits additional comment on this proposed method of
follow-up processor reporting. After reviewing comments to be
received on this proposal, we will publish the final requirements
for processor reporting in the Federal Register.
B. Who Must Report
In the proposed second round of reporting to collect
information for preliminary assessment, persons who processed for
commercial purposes certain chemical substances during the
reporting year would submit the Processor's Follow-up Report —
Preliminary Assessment Information. The chemicals would be listed
in § 712.50 and published in a Federal Register notice, along with
a date by which reports would be submitted to EPA. The proposed
requirements for reporting are described in this section of the
preamble and appear in § 712.48 of the rule. Processors who would
be specifically exempted are described at III.B below.
Several comments requested clarification of the distinction
between "processor," "user," and "distributor." The primary concern
of the commenters was that the use of a chemical to manufacture a
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different chemical should not be considered processing. They
suggested that if a person's activities change a listed chemical so
that it no longer exists in its listed chemical form, the person is
a "user" and consequently should not be subject to follow-up
reporting.
The Agency disagrees with this interpretation. "Processing"
includes any preparation of the chemical substance for distribution
in commerce as part of a mixture, an article, or any product
containing or composed of the chemical substance. Processing also
includes the use of a chemical as a reactant or intermediate to
produce another chemical substance. If a company only uses and
discards the chemical at its plant site, the company is not a
processor.
A processor is, among other things, one who prepares a
chemical substance or mixture for distribution in commerce, after
its manufacture, in the same or different form or physical state
from that in which it was received by the processor (see TSCA
section 3(10)). One who mixes, reacts, purifies, separates,
repackages, or otherwise "prepares" a chemical substance or mixture
for distribution in commerce is also a processor. A person who
reacts a listed chemical substance to make another chemical for
distribution in commerce has prepared that chemical substance for
distribution in commerce in a form different from the one in which
the person originally received it.
Furthermore, a person who reacts a chemical substance subject
to this rule to produce another chemical substance is a
manufacturer of a chemical substance and may be subject to a
section 8(a) rule as a chemical manufacturer. TSCA section 8(a)
authorizes EPA to require manufacturers of a chemical substance to
report on the chemicals they react in the manufacturing process.
For example, EPA may need data on chemical A. Companies that react
chemical A with chemical B to manufacture chemical C are
manufacturers of chemical C. EPA may require them as chemical
manufacturers to report data oh chemicals A and B because they are
reacted to manufacture chemical C.
"Users," who do not have to report for this rule, are persons
who only use or discard a chemical substance or mixture. One who
uses a listed chemical substance or mixture to maintain or repair
his equipment, or to otherwise maintain the plant, would be a user
only. For example, the purchaser of a piece of machinery who
painted the machinery for maintenance or repair would be a user of
the paint. However, if the manufacturer of the same machinery
painted it before selling the machinery, he would be a processor of
the paint.
A "distributor" is one who "distributes in commerce" as
defined in TSCA section 3(4). The terms "distribute" and
"commerce" are both defined in the Act and do not need further
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definition. Distributors are not subject to reporting under this
rule.
C. Processors Exempt From Reporting
The same exemptions that apply to manufacturers would also
apply to processors. These exemptions are discussed more fully in
the final manufacturer's reporting requirements published elsewhere
in today's Federal Register. In general, the following processors
would be exempt from reporting for a plant site in the following
situations:
1. Small processors. This proposal complies with the
Regulatory Flexibility Act by exempting small processors from
reporting requirements, except in very limited cases. Processors
would be "small" in respect to a listed chemical if total annual
sales of the foreign or domestic parent company were below $30
million during the reporting period, and the plant site processed
below 45,400 kilograms (100,000 pounds) of the listed chemical
during the reporting period.
Small processors would be required to report only on a chemi-
cal subject to TSCA section 4, 5(b)(4), or 6 proposed or final
rules, and only if the additional information from small processors
is likely to have a significant effect on EPA decisions.
2. Processors of small quantities. No one would report on a
chemical processed in quantities below 500 kilograms (1,100 pounds)
per year at any plant site.
3. Processors of substances in mixtures and articles.
Persons would not report on processing of substances already
incorporated in mixtures or articles.
4. .Research and development. Persons would not report on
chemical processing that is solely for research and development or
scientific analysis.
5. Impurities and byproducts. Persons would not report on
listed chemicals that are processed solely because they are
byproducts or impurities associated with processing of another
chemical.
D. What Chemicals Must Be Reported
Processors would report on chemicals for which manufacturers
could not provide sufficient customer use information. If the
aggregate unaccounted for in all manufacturers' reports is greater
than 20 percent of the total quantity manufactured and imported,
the chemical would be subject to processor reporting. However,
processors would report only on the trade names of manufacturers
who did not account for 80 percent of their quantity manufactured
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and imported. This criterion allows us to extrapolate the uses of
remaining quantities with sufficient confidence. EPA would issue
a Federal Register notice containing the names under which these
chemicals are sold. A processor of a listed chemical must report.
Persons who process the following preparations of a chemical
substance must report:
1. The chemical substance in aqueous solution;
2. The chemical substance containing a small amount of an
additive (such as a stabilizer or other chemical) to maintain the
integrity or physical form of the substance;
3. The chemical substance in any grade of purity.
A chemical with additives is sold and used as the chemical
substance. The Agency's purpose in asking about such products is
to determine the use and potential exposure of that chemical
substance. Congress recognized this need in the Conference Report
on the Act: "Thus the definition of [the] term 'chemical
substance' shall be applied to chemical substances as actually
produced and marketed" H.R. Rep. No. 1679, 94th Cong., 2d Sess. 57
(1976) (Conference Report). Substances are rarely marketed in pure
form and very often other chemicals are added to insure that the
substance does not degrade during transport. In these cases it is
the substance that is being marketed in the eyes of both seller and
buyer. Under the definition of "mixture" in TSCA section 3(8), a
substance with an additive would be a mixture. However, for this
information collection to be effective in accounting for the
processing of substances, substances with additives must be
reported. Thus to the extent that the rule requires reporting on
these "mixtures," the Administrator finds that it is necessary for
the effective enforcement of TSCA.
As in the manufacturer's rule, processors would report only on
chemicals processed for purposes regulable under TSCA.
E. Processor's Reporting Form
Processors would submit the Processor's Follow-up Report —
Preliminary Assessment Information, EPA form Number 7710-35a. The
proposed processor's form contains only the questions regarding
customer use from Part B of the manufacturer's form. Thus, the
processor's form itself is a modification of Part B of the
manufacturer's form.
Processors would report their best estimate of the total
quantity of chemical substance they processed in the reporting
year, and the quantities processed for various product types. The
estimates would be based on readily obtainable data. The proposed
form also contains a question on the process categories used for
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the chemical. This information would be used to supplement data
reported by manufacturers.
The same guidance and accuracy as described for manufacturers
on Part A of their form is required of processors. See 40 CFR Part
712, Subpart B published elsewhere in this issue of the Federal
Register.
F. When to Report
A processor would report data for the same period as reported
by the manufacturer of the published trade name chemical. This
period would be published in the Federal Register notice for each
chemical on which processors must report. Processors would submit
EPA form No. 7710-35a within 30 days of the effective date of the
Federal Register notice announcing reporting. If a company must
report on more than 15 chemicals listed in the notice, it may
petition EPA for an extension of time as prescribed in § 712.45(g)
of the rule.
III. Additional Chemicals Subject to the Rule
A. Automatic Reporting of Future ITC-Designates
We are proposing an amendment to Subpart B — Manufacturers
Reporting Requirements that would automatically have manufacturers
report on certain chemicals within 60 days. In the same manner as
for chemicals previously listed in Subpart B, processors would be
subject to reporting on these chemicals only if manufacturers
failed to provide enough information.
The chemicals for which we proposed automatic reporting are
chemical substances or designated mixtures that the Interagency
Testing Committee (ITC) recommends for testing. Within one year
after the ITC recommends a chemical for testing, EPA must initiate
rulemaking to require testing under section 4 of TSCA or publish
its reasons for not initiating rulemaking. Because of the short
time allowed for this decision, the Agency must proceed as rapidly
as possible to gather available data on a chemical.
To decide within one year whether to propose a test rule, EPA
must complete its preliminary exposure analysis of the chemical
about four months, in most cases, after the ITC recommendation. If
Preliminary Assessment Information reports are submitted
automatically under this rule, EPA will have accurate and
sufficiently complete exposure data from manufacturers within about
three months after the ITC recommendation. This timetable assumes
that we add the chemicals to § 712.30 by publishing a notice in the
Federal Register within 10 days after the Federal Register
publication of the ITC's recommendations. With an effective date
30 days after the date of the EPA Federal Register publication, and
a due date 60 days after the effective date, EPA would have basic
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exposure data from manufacturers in about 100 days. This would
allow the Agency about one month to complete the preliminary
exposure analysis that would be based partially on the data. On
the other hand, if the chemicals were proposed for comment, an
additional two to three months, at a minimum, would be required to
give time for the comment period. Because of the constraints on
decision making time for ITC-recommended chemicals, and because
this notice solicits comment from all potential respondents on the
purpose and requirements of the rule as it will be used, EPA does
not propose to go through additional rulemaking to add these
chemicals to the rule.
In the infrequent cases when processors must report, EPA would
be working with incomplete data on the substances involved until
about six months after the Federal Register publication of ITC's
recommendations. This assumes that EPA would publish the chemicals
for processor reporting in § 712.50 about 10 days after basic
exposure data is available from manufacturers; that there would be
an effective date 30 days after the date of this Federal Register
publication; and that there would be a due date for processor
reports 30 days after the effective date. Since recognition of the
need for processor reporting depends on data from manufacturers, we
cannot speed the processor reporting timetable. However, we
anticipate requiring processor reporting very infrequently, and on
very few chemicals, so that the number of instances in which EPA
will have incomplete data for an interval of time will be very few.
• • * • •
IV. Economic impact
The cost estimate of the proposed amendments has two parts.
The Agency estimates for planning purposes that it will
receive insufficient information for preliminary assessment on
approximately 10 percent of the 250 chemicals on which manufac-
turers must report. A better estimate cannot be established until
the manufacturer reporting is under way, so the Agency will revise
its cost estimates before processor reporting is required.
For the current estimate, we assume that five manufacturers
will report on each chemical, and that three of these manufacturers
will report unknown customer uses for more than 20 percent of the
quantity they manufactured and imported during the reporting
period. We also assume that there will be an average of 10
customers per manufacturer's report, and that five of the customers
will be distributors and two will be small businesses not required
to report. On this basis, the Agency estimates that approximately
225 processor reports would be required under this rule. At an
average cost of $255 per plant site plus $100 per report to prepare
and submit the Processor's Reporting Form, the total of the
proposed processor reporting provisions would be $91,000. (For
discussion of reporting costs, see Economic Impact and Small
Business Definition Analysis for the final TSCA Section 8 (a)
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Preliminary Assessment Information Rule, prepared by ICF, Inc.,
1981.) This cost assumes that processors will not be required to
search files to determine trade names of chemicals processed. The
Agency requests comments on its estimate of the cost of submitting
the form and on the overall economic impact of this rule.
The 50 additional chemicals listed in this amendment will have
total reporting costs of $60,000. This includes 40 manufacturers
submitting a total of 60 reports. With fixed costs of $480 per
site, and variable costs of $420 per report, the manufacturers'
costs are $44,000 for these 50 chemicals. The $60,000 also
includes $16,000 as the cost of processors' reporting. Again we
assume that manufacturers data will be incomplete for 10 percent of
the 50 chemicals, and that nine customer-processors will report per
chemical
VI. RulemaJcing Record
This proposed rule, "Processors Follow-up Reporting —
Preliminary Assessment Information" (OPTS-82004G) is also included
in the public record
VII. Regulatory Assessment Requirements
B. Regulatory Flexibility Act
Consistent with the purposes of the Regulatory Flexibility
Act, the Agency has proposed here a definition of the businesses
that will be excluded from reporting because they are small
processors. Similarly, small manufacturers have already been
defined and excluded from manufacturer reporting requirements. In
addition, the average cost of reporting for a manufacturer or a
processor under this proposal is small. It is $1100 for a
manufacturer, and $400 for a processor (see above discussion of
economic impact).
In view of the exemptions and the small cost per company, the
Agency finds that this proposal, if adopted, would not have a
significant impact on a substantial number of small entities.
C. Paperwork Reduction Act
The Paperwork Reduction Act, 44 U.S.C. 3501 et seq.,
authorizes the Director of the Office of Management and Budget to
review certain information collection requests by Federal agencies.
The reporting provisions in this rule have been approved by the
Office of Management and Budget (OMB) under section 3504(b) of the
Paperwork Reduction Act of 1980, 3501 et seq., and have been
assigned OMB control number 2000-0420.
The proposal contains a one-page form to be completed by
processors of certain chemicals. Processors will complete the form
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only when manufacturers of the chemicals are unable to provide
certain data about processing. The proposal is designed to
minimize processor reporting. Processors will be required to
report only if manufacturers cannot supply adequate data on their
processor-customers. These processor-customers report directly to
EPA
PART 712 — CHEMICAL INFORMATION RULES
Therefore, it is proposed that 40 CFR Part 712 be amended as
follows:
2. Subpart C is being added to read as follows:
Subpart C — Processor's Follow-Up Reporting — Preliminary
Assessment Information
Sec.
712.40 Processors who must report.
712.45 Exempt processors.
712.48 Form and instructions.
712.50 Chemical lists and reporting periods.
Authority: (Sec. 8(a), Toxic Substances Control Act, Pub. L.
94-469 (90 Stat. 2003, 15 U.S.C. 2607(a) et seq.)).
Subpart C — Processor's Follow-Up Reporting — Preliminary
Assessment Information Rule
§ 712.40 Processors who must report.
Except as described in § 712.45, at the time a chemical
substance is listed in § 712.50, persons who processed the chemical
substance for commercial purposes during the reporting period
indicated must submit a "Processor's Report — Preliminary
Assessment Information" (as described in § 712.48) for each plant
site where they processed the chemical substance.
§ 712.45 Exempt processors.
The following persons are exempt from reporting under §
712.40:
(a) Persons who reported their manufacture and processing of
the chemical substance under § 712.30 are not subject to reporting
under § 712.40.
(b) Persons who processed the chemical substance solely for
purposes of scientific experimentation, analysis, or research,
including research or analysis for product development, are not
subject to reporting under § 712.40.
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(c) Persons who processed below 500 kilograms (1100 pounds) of
the chemical substance at a single plant site are not subject to
reporting for that site under § 712.40.
(d) Persons who qualify as small processors in respect to a
specific chemical listed in § 712.50 must report on the chemical
only if it is designated by an asterisk. A small processor is
exempt from submitting a report under this Subpart for a chemical
substance processed at a particular plant site if both the
following criteria are met:
(1) Total annual sales taken together of all sites owned or
controlled by the foreign or domestic parent company were below $30
million during the reporting period.
(2) The total amount of the listed substance processed at the
plant site during the reporting period was below 45,400 kilograms
(100,000 pounds).
(e) Persons are not subject to reporting under § 712.40 if
they processed the chemical substance only in the following forms:
(1) A byproduct that was not used or sold or that was formed
as described in 40 CFR 710.4(d)(3) through (7).
(2) An impurity.
(3) A mixture or article containing the listed chemical
substance.
§ 712.48 Form and instructions.
(a) Processors subject to this Subpart must submit a single
EPA Form No. 7710-35a, "Processor's Follow-up Report
Preliminary Assessment Information," for each plant site processing
a chemical substance listed in § 712.50.
(b) Chemical substances will be listed under § 712.50 only
when the data submitted on Manufacturer's Report — Preliminary
Assessment Information under Subpart B show unknown customer uses
for more than 20 percent of the aggregate total manufactured and
imported. Processor follow-up reporting will be required on
chemical substances that are marketed by manufacturers who reported
unknown customer uses for more than 20 percent of the total
quantity they manufacture and import.
(c) The designation of chemical substances for reporting by
processors will be made by Federal Register notice.
(d) Reporting companies may submit their reports through
individual plant sites or company headquarters as they choose. A
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separate form must be submitted for each plant site processing the
chemical substance
(g) If a processor must report on more than 15 chemical
substances he may petition the Assistant Administrator of
Pesticides and Toxic Substances for an extension of time. Requests
for extensions should be submitted to: Document Control Officer,
Office of Pesticides and Toxic Substances (TS-793), Environmental
Protection Agency, Room E-401, 401 M St., SW. , Washington, DC
20460.
(h) Instructions and a facsimile of the form are as follows:
INSTRUCTIONS FOR
PROCESSOR'S REPORT FORM
PRELIMINARY ASSESSMENT INFORMATION
What chemicals to report - This form applies to chemical substances
that are listed in 40 CFR 712.50.
Reporting period - Enter the month and year beginning and ending
the 12-month period for which you report. This reporting period is
listed with the chemical substance in 40 CFR 712.50.
Who must report - All firms who purchased and processed a chemical
under one of the names listed in 40 CFR 712.50 must report.
How many forms to complete - For each chemical, complete separate
form for each plant site that processed the chemical.
Who may submit forms - Companies may choose to complete and submit
forms directly to EPA from each plant site, or through company
headquarters.
Retention of forms - You should keep a copy of each completed form.
Refer to the form's preprinted Control Number (shown in the upper
right corner) when communicating with EPA
IV. PROCESSING ACTIVITIES
Accuracy - For each item, provide numbers that represent your best
estimates based on readily obtainable data.
TSCA Regulable Quantities - Do not report any quantity of chemical
substance that is processed solely for use as: a pesticide; tobacco
or any tobacco product; any source material; special nuclear
material, or byproduct material (as such terms are defined in the
Atomic Energy Act of 1954 and regulations issued under such Act);
firearms or ammunition; or food, food additive, drug, cosmetic, or
device (as such terms are defined in section 201 of the Federal
Food, Drug and Cosmetic Act). The above are not TSCA regulable.
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Item 1 - Enter the total quantity you processed during the
reporting period.
Item 2 - Report the quantity of the chemical substance that you use
or process for each of the categories in 2a to 2h. Include the
quantity of the chemical substance itself, and the quantity of
chemical substance in any product that you distribute.
For items 2a through 2g, if you are not sure about whether your
products are for domestic or foreign use, report them as domestic.
The products are divided into industrial and consumer products.
"Industrial" means the manufacturing and service industries covered
by the Standard Industrial Codes. Products meant to be used
primarily by the general population are considered to be "consumer"
products. The following definition from the Consumer Product
Safety Act can be used as a guide (15 U.S.C. 2052 (a) (1)): "The term
"consumer product" means any article, or component part thereof,
produced or 'distributed (i) for sale to a consumer for use in or
around a permanent or temporary household or residence, a school,
in recreation, or otherwise, or (ii) for the personal use,
consumption or enjoyment of a consumer in or around a permanent or
temporary household or residence, a school, in recreation, or
otherwise." If you are uncertain about whether your products are
industrial or consumer, report them as consumer.
Three types of industrial and consumer product types are described
below.
"Chemical substance or mixture" means a chemical, or mixture
containing the chemical, that is used directly by the persons using
the product, e.g., cleaners, paints, inks, deodorizers, solvents,
etc. This includes chemicals or mixtures in containers or other
articles whose purpose is to release the chemical (e.g., cans of
spray paint, ink pens, and other applicators).
"Articles or products with no release" are articles constructed in
a way to prevent human exposure to or release to the environment of
the chemical substance during normal use and storage (e.g.,
chemical coatings on internal components, and chemicals inside
sealed articles as in thermometers and batteries).
"Articles or products with some release" are articles whose
material components are made of chemicals which come in direct
contact with persons using the article, the atmosphere, land, or
water; e.g., exposure can come from leaching, evaporation, or
surface contact. This includes such articles as plastic
containers, chemically treated textiles, printed paper, coated
appliances, etc. if the chemical itself is sold in a bottle or
other container it should be reported under "Chemical substance or
mixture," not as an article. Only the container itself is an
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article for purposes- of this form; the substance it contains is not
a component of an article.
In item 2g, report the quantity of chemical substance that you
export directly either as the chemical or contained in mixtures or
articles.
In item 2h, report the quantity of chemical substance that you
react to make products that do not contain the chemical substance
itself.
Item 3 - List the quantity of chemical substance that you process
n each of the following process categories.
Enclosed process - The process is designed and operated so that
there is no intentional release of the chemical. In this process
category, only fugitive or inadvertent releases occur, and special
measures are taken to prevent worker exposure and environmental
contamination. "Special measures" refer to procedures and
equipment that are monitored and used to prevent worker exposure,
and scrubbers and other recovery equipment employed to prevent
environmental release. Equipment with emergency pressure relief
venting would be allowed in this category; routine venting would
not.
Controlled release process - The process is operated in a
controlled manner to minimize release of the chemical into the
workplace. Releases should generally be within prescribed limits.
These limits may be dictated by government regulations or by
company guidelines. If the chemical is vented outside the plant,
the process is a "controlled release" process. Do not count
general space ventilation fans.
Open process - The chemical is routinely in direct contact with the
atmosphere (workplace or outside the plant) and no measures are
taken to prevent release. For example, reaction vessels are open
vats, the chemical is transported or stored in open containers, or
the chemical is freely vented into the workplace atmosphere
§ 712.50 Chemical list and reporting periods.
(a) Subject chemical substances. A Preliminary Assessment
Information Processor's Report must be submitted by the deadline
specified for each chemical substance listed below. The reporting
period for each chemical is the 12-month period for which
manufacturers provided incomplete information.
(b) [Reserved].
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"ASBESTOS"
CODE OF FEDERAL REGULATIONS (CFR)
Part 763 — Asbestos
Subpart D - Reporting Commercial and Industrial Uses of
Asbestos
40 CFR §763.63(k) defines "Process for commercial purposes" as
"the preparation of a chemical substance or mixture, after its
manufacture, for distribution in commerce with the purpose of
obtaining an immediate or eventual commercial advantage for the
processor. Processing of any amount of a chemical substance or
mixture is included. If a chemical or mixture containing impurities
is processed for commercial purposes, then those impurities are
also processed for commercial purposes."
FINAL RULE [47 Fed. Reg. 33198 (30 July 1982)]
"EPA will require detailed information on EPA Form 7710-
36, 'Reporting Commercial and Industrial Uses of
Asbestos,1 from the first group -- persons who mine,
mill, or import bulk asbestos, or process it to form an
asbestos mixture or product, such as asbestos paper. The
latter persons are called 'primary processors of
asbestos.' This first group must report within 90 days
of the effective date of this rule.
"EPA will require reporting in two phases for the second
group — secondary processors of asbestos (secondary
processors of asbestos make products from asbestos
mixtures, not bulk asbestos,) and persons who import
asbestos mixtures or other products that contain
asbestos."
Id., at 33202:
"TSCA defines a processor, in part, as a person who
prepares a chemical substance or mixture, after its
manufacture, for distribution in commerce. This rule
classifies processors into two groups according to their
starting material. 'Primary processors of asbestos' are
those whose starting material is bulk asbestos.
•Secondary processors of asbestos' are those whose
starting materials are asbestos mixtures.
"A primary processor starts with bulk asbestos and makes
a mixture that contains asbestos fiber. A primary pro-
cessor may simply mix or repackage different types or
sizes of fiber and then sell that product. Such mixing
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or repackaging of fibers is considered primary processing
of bulk asbestos for the purpose of this rule. Asbestos
mixtures are products to which asbestos fiber has been
intentionally added and which can be used or processed
further and incorporated into other products. For
example, asbestos cement, asbestos paper, and asbestos-
reinforced plastics are asbestos mixtures. In some
cases, a primary processor further processes the asbestos
mixtures. If so, the person is also a secondary
processor. For instance, asbestos paper can be further
processed to incorporate it into an article, or asbestos-
reinforced plastics can be further processed to make
vinyl-asbestos floor tile. ....
"'Secondary processors are those who start with asbestos
mixtures and incorporate them into their own products.
For example, persons who fabricate asbestos cement sheet
by cutting the sheet to make an electrical switch board,
or persons who make garments by cutting an asbestos tile,
are secondary processors. A person who fabricates
asbestos cement sheet by cutting it to a specific
dimension for a customer is a secondary processor. An
automobile manufacturer is a secondary processor if he
incorporates asbestos felt into an automobile as a hood
insulation blanket or makes heating vent ducks [sic.,
ducts] from asbestos paper. A paint formulator is a
secondary processor if he purchases a paint that contains
asbestos and reformulates the paint by adding some agent
to give the paint special properties for specific
applications."
Id., at 33203:
"Reporting is not required by persons who are 'end users'
of bulk asbestos or asbestos products and do not further
distribute such items in commerce. The most common
example of this is in the manufacture of chlorine, where
some persons use asbestos as a diaphragm to separate
chlorine and caustic soda. While much bulk asbestos is
consumed annually by this industry and much waste
generated, asbestos fiber is not present in the resultant
products which are distributed in commerce and these
activities are therefore not 'processing' of asbestos."
PROPOSED RULE [46 Fed. Reg. 8200 (26 January 1981)]
"Under TSCA, manufacturers of asbestos are persons who
mine, mill, or import asbestos in bulk form or as part of
a product containing asbestos. Processors of asbestos are
persons who make products for distribution in commerce
which contain asbestos or any asbestos containing
component.
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"EPA emphasizes that the terms 'manufacturers' and
'processors' as used in TSCA, to some extent, have
different meanings from common usage. Section 3 of TSCA
defines 'manufacturer1 to include manufacturers, pro-
ducers, and importers. Thus, miners and millers of
asbestos are 'manufacturers' under TSCA, as are im-
porters. Importers include those persons who import
asbestos in bulk form, or as part of any product. Thus,
persons who import automobiles that contain asbestos
brake linings are 'manufacturers' of asbestos for
purposes of TSCA.
"'Processors' of asbestos are persons who prepare
asbestos, after manufacture, for distribution in commerce
in the same or different form as they received it or as
part of a product that contains asbestos. Thus, persons
who incorporate asbestos or asbestos-containing
components into products are processors under TSCA, even
if they consider themselves 'users' of a product that
contains asbestos."
Id., at 8204:
"TSCA defines a processor in part as a person who
prepares a chemical substance or mixture, after its
manufacture, for distribution in commerce. This rule
classifies processors into two groups according to their
starting material. 'Primary' processors of asbestos are
those whose starting material is bulk asbestos (a chemi-
cal substance). 'Secondary1 processors of asbestos are
those whose starting materials are asbestos mixtures.
"A primary processor starts with bulk asbestos and makes
a mixture that contains asbestos fiber. (A primary
processor may simply mix or repackage different types or
sizes of fiber and then sell that product. Such a mix of
fibers is still considered 'bulk asbestos' for the
purpose of this rule.) Asbestos mixtures are products to
which asbestos fiber has been intentionally added and
which can be used or processed further and incorporated
into other products. For example, asbestos cement,
asbestos paper, and asbestos-reinforced plastics are
asbestos mixtures. In some cases, a primary processor
further processes the asbestos mixtures. If so, the
person is also a secondary processor. For instance,
asbestos paper can be further processed to incorporate it
into an article or asbestos-reinforced plastics can be
further processed to make vinyl-asbestos floor tile. . .
"'Secondary processors' are those who start with asbestos
mixtures and incorporate them into their own products.
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For example, persons who fabricate asbestos cement sheet
by cutting the sheet to make an electrical switch board,
or persons who make garments by cutting an asbestos
textile, are secondary processors. An automobile
manufacturer is a secondary processor if he incorporates
asbestos felt into an automobile as a hood insulation
blanket or makes heating vent ducts from asbestos paper.
A paint formulator is a secondary processor if he
purchases a paint that contains asbestos and reformulates
the paint by adding some agent to give the paint special
properties for specific applications
"Certain secondary processors are excluded from this
rule. They are persons who repair articles, repackage
asbestos mixtures without modification, or who engage in
construction work. Other secondary processors are
exempted if they apply, assemble, install, erect, or
consume asbestos products without modifying or fabri-
cating the asbestos products. While we believe there may
be a substantial risk from asbestos exposures in these
categories, we expect to complete necessary analyses with
estimates and extrapolations of data reported by persons
who make the asbestos-containing products that are
processed by the excluded industries. Therefore, reports
from these excluded industries are not essential. . . .
"Reporting is not required by persons who use bulk
asbestos or asbestos products but do not distribute them
in commerce as part of a product. The most common
example is in the manufacture of chlorine, where some
persons use asbestos as a diaphragm to separate the
chlorine and the caustic soda. While much bulk asbestos
is consumed annually by this industry and much waste
generated, asbestos fiber is not present in the resultant
products which are distributed in commerce and these
activities are therefore not 'processing1 within the
meaning of TSCA."
Id., at 8209 [language of proposed rule § 763.63]:
" (g) 'Manufacture for commercial purposes' means to
import, produce, or manufacture with the purpose of
obtaining an immediate or eventual commercial advantage
and includes among other things, such manufacture of any
amount of a chemical substance or mixture:
"(1) For commercial distribution, including
for test marketing, and
"(2) For use by the manufacturer, including
use for product research and development, or
as an intermediate.
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•Manufacture for commercial purposes' also applies to
substances that are produced coincidentally during the
manufacture, processing, use, or disposal of another
substance or mixture, including both byproducts and
coproducts that are separated from that other substance
or mixture and impurities that remain in that substance
or mixture. Byproducts and impurities may not, in
themselves have commercial value. They are nonetheless
produced for the purpose of obtaining a commercial
advantage since they are part of the manufacture of a
chemical product for a commercial purpose
11 (k) 'Process for commercial purposes' means the
preparation of a chemical substance or mixture, after its
manufacture for^distribution in commerce with the purpose
of obtaining 'an immediate or eventual commercial
advantage for the processor. Processing of any amount of
a chemical substance or mixture is included. If a
chemical substance or mixture containing impurities is
processed for commercial purposes, then those impurities
are also processed for commercial purposes."
Id., at 8213 [prop, language for reporting form directions]
"Secondary Processor: means a person whose asbestos
starting material is an asbestos mixture, which is
incorporated into that person's own product. For
example, asbestos millboard may be purchased by a
secondary processor, who could cut that millboard and
incorporate it into an appliance; A/C sheet may be
purchased by a secondary processor, who could fabricate
it to make the backing for an electrical switchboard."
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S8(b) ("INVENTORY.")
TSCA (THE ACT)
TSCA §8(b)(l) states that "The Administrator shall compile,
keep current, and publish a list of each chemical substance which
is ... processed in the United States. Such list shall at least
include each chemical substance any person reports, under section
5 [("MANUFACTURING AND PROCESSING NOTICES.")] or subsection (a) of
this section, is ... processed in the United States. Such list
may not include any chemical substance which was not . . . pro-
cessed in the United States within three years before the effective
date of the rules promulgated pursuant to the last sentence of
subsection (a)(1). In the case of a chemical substance for which
a notice is submitted in accordance with section 5, such chemical
substance shall be included in such list as of the earliest date
(as determined by the Administrator) on which such substance was .
. . processed in the United States "
§8(b) (1) of TSCA states also that "The Administrator shall not
include in such list any chemical substance which is ... pro-
cessed only in small quantities (as defined by the Administrator by
rule) solely for purposes of scientific experimentation or analysis
or chemical research on, or analysis of, such substance or another
substance including such research or analysis for the development
of a product."
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S8(c) ("RECORDS.")
T8CA (THE ACT)
TSCA §8(c) states that "Any person who . . . processes . . .
any chemical substance or mixture shall maintain records of
significant adverse reactions to health or the environment, as
determined by the Administrator by rule, alleged to have been
caused by the substance or mixture Records required to
be maintained under this subsection shall include . . . [certain
types of cited reports] submitted to the . . . processor in
commerce from any source "
CODE OF FEDERAL REGULATIONS (CFR)
Part 717 — Records and Reports of Allegations that Chemical
Substances Cause Significant Adverse Reactions to Health or
the Environment
Subpart A - General Provisions
According to 40 CFR §717.3 ("Definitions"), all definitions in
section 3 of TSCA apply to this part. In addition, 40 CFR §717.3
provides the following additional process-related definitions:
40 CFR §717.3(d), "process" means "to process for commercial
purposes."
40 CFR §717.3(g), defines "Process for commercial purposes" to
mean "the preparation of a chemical substance or mixture, after its
manufacture, for distribution in commerce with the purpose of
obtaining an immediate or eventual commercial advantage for the
processor. Processing of any amount of a chemical substance or
mixture is included. If a chemical or mixture containing impurities
is processed for commercial purposes, then those impurities are
also processed for commercial purposes."
It should be noted that in 40 CFR §717.5 ("Persons subject to
this part."), processors are identified specifically as subject
persons; with regard to this coverage, 40 CFR §717.5(b) states that
"(1) a person who processes chemical substances, who is not a manu-
facturer of those chemical substances, is subject to this Part if
(i) the person processes chemical substances to produce mixtures,
or (ii) the person repackages chemical substances or mixtures."
Proposed 8(c) Rule Text
§ 717.13 Who is subject to this Part.
"All manufacturers, processors, and all persons who dis-
tribute substances in commerce, except retailers, are
subject to this rule...."
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Final 8(c) Rule Text
§ 717.5 Persons subject to this Part.
(b) Processors. (1) A person who processes chemical
substances, who is not also a manufacturer of those
substances, is subject to this part if such person is
engaged in Standard Industrial Classification (SIC) Major
Group 28—Chemicals and Allied Products, and SIC code
2911—Petroleum Refining.
Proposed 8(c) Rule Amendment Text
§ 717.5 Persons subject to this Part.
(b) Processors. (1) A person who processes chemical
substances, who is not also a manufacturer of those
substances, is subject to this part if the products that
person distributes in commerce are of the type described
in Standard Industrial Classification (SIC) Major Group
28—Chemicals and Allied Products, and SIC code 2911—
Petroleum Refining.
Final 8(c) Rule Amendment Text
§ 717.5 Persons subject to this Part.
(b) Processors. (1) A person who processes chemical
substances, who is not also a manufacturer of those
substances, is subject to this part if (i) the person
processes chemical substances to produce mixtures, or
(ii) the person repackages chemical substances or
mixtures.
Preambles to Proposed and Final 8(c) Rule and Amendment
From the proposed 8(c) rule (45 FR 47008; 7/11/80)
"Persons who process chemical substances or mixtures
include companies that manufacture consumer goods or
industrial products. Manufacturers of automobiles, paper
products, textiles, electronic components, for example,
should consider commenting on this proposed rule." (at p.
47008)
"The term "process" is defined in TSCA to mean ... Thus,
persons who ordinarily consider themselves to be "users"
because all they do is incorporate a chemical into an
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article, are considered "processors" under TSCA." (at
page 47009)
162
page
From the final 8(c) rule (48 FR 38178; 8/22/83)):
C. Processors Subject to the Rule
There are two types of processors subject to this rule. If a
company is processing a chemical it manufacturers, that company
must collect allegations on any of its processing or distribution
in commerce activities involving that chemical. See A of this unit.
If a company is processing a chemical it does not manufacture,
that company must collect allegations involving that chemical only
for those activities described in Standard Industrial
Classification (SIC) Major Group 28-Chemical and Allied Product, or
SIC code 2911-Petroleum Refining. It also must collect allegations
relating to any further processing or distribution in commerce of
any products resulting from such processing activities.
Thus, a firm that processes chemical substances but that is
not a manufacturer can be subject to this rule. However, the
Agency has decided to limit the applicability of the rule where
this type of processor is concerned. The Agency has concluded that
the best approach is to concentrate the recordkeeping
responsibility with those firms that have at least one plant site
engaged in activities within the mainstream of the chemical
industry. The Agency believes that such processors are likely to
be among the firms that have the greatest stake in recording and if
appropriate, taking positive or corrective action with respect to
allegations received. The Agency feels that by focusing the
recordkeeping responsibility with these processors the rule
enhances the concept of product stewardship, a growing practice
within the chemical industry that continually assesses the
potential health and safety risks of substances at each stage from
development through disposal.
Again, the Agency considers it necessary to outline for
processor subject to this rule their specific responsibility
regarding collection of allegations. Such processors must collect:
1. Any allegation identifying any chemical substance,
mixture, or article resulting only form processing activities
as described in SIC 28 or SIC 2911, or identifying the
operations involved in making such products (See unit III B.
of this preamble and § 717.10 of the rule).
2. Any allegation identifying any of its own further
processing or distribution in commerce activities of the
products described in 1. above.
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3. Any allegation identifying emissions, effluents, or other
discharges from activities described above.
Note that if a company is not a manufacturer of a chemical
substance, but is only a processor, it is only required to collect
allegations relating to products resulting from activities
described in SIC codes 28 and 2911. A processor subject to this
rule is not required to collect allegations involving substances it
does not produce. For example, an allegation specifically
involving a mixture component bought from some other company does
not have to be collected (although allegations involving the
processing of the component or the new product created would be
collected by the processor). As with manufacturers, the Agency
believes that processors have a strong incentive to forward
allegations on a mixture component to the supplier of that
component. The Agency strongly encourages this passback activity.
At this juncture, the Agency wishes to make clear two very
important points relating to processing operations and the use of
SIC codes in this preamble and rule. First, when a company is
deciding whether it is "engaged in activities described" in SIC
codes, it must refer to the descriptions that appear after each
four digit code. The company should not rely solely on the listing
of substances that appears after the descriptions. These
descriptions are generic in nature and refer to the production of
categories of chemicals, mixtures, or other chemical products. It
is quite possible that a company may be processing chemicals to
produce a substance or product that does not specifically appear in
the list of substances that follows the generic description.
The second point is that terms used in the SIC codes are not
necessarily the same as those used in this rule. For the purposes
of this rule, TSCA definition of "manufacturing" and "process"
apply. Activities described in SIC codes 28 and 2911 are
categorized by the SIC system as "manufacturing." This term is
broader than the TSCA definition of manufacture and encompasses
activities referred to as "processing" under this rule. For
example, a company referred to under SIC code 2851 as engaged in
the activity of manufacturing paints is, for the purposes of this
rule, a processor of the chemicals used to make the paints. Thus,
it is subject to this rule as a chemical "processor" engaged in an
activity described in SIC code 28. (The company is also a mixture
manufacturer under TSCA definitions.) Accordingly, section
717.5(c) of the rule provides that where there is a conflict
between the SIC codes uses of a term and the definition of that
term in this rule, the rule definition applies.
D. Processors Not Subject to the Rule.
A processor, who is not also a manufacturer is not subject to
this rule if none of the sites it owns or controls is engaged in
activities described in SIC 28 or SIC 2911. The TSCA definition of
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processor is such that tens of thousands of firms could be made
subject to recordkeeping responsibilities of section 8(c). For
example, a shoemaker that applies a dye to shoes is technically a
processor because of the incorporation of that chemical dye into an
article for distribution in commerce. Likewise, a hardware store
that adds a pigment to premixed paint is a processor.
Such "processing" permeates the economy. To include firms
engaged in activities of this nature under the rule would create a
vast recordkeeping requirement. The economic analysis for the
proposed rule estimated that some 543,000 establishments outside of
SIC 28 or 2911 could be made subject to this rule as processors.
Requiring these establishments to collect allegations would be an
administrative nightmare. Further, the public health concerns of
section 8(c) would not be harmed by excluding these establishments
because they would have a strong incentive to refer complaints
about chemicals they "process" to the suppliers of those chemicals-
firms that are likely to be subject to this rule.
In this final.rulemaking, the Agency did consider making such
"other" processors subject but with an alternative compliance
method. The purpose would be to promote the passback of allega-
tions to those required to maintain records. In brief, such firms
could be required to record allegations or they could discharge
this responsibility by forwarding such allegations to their
supplier. This would be similar to the alternative compliance
mechanism for distributors as outlined in the proposed rule.
After evaluating this alternative compliance method the Agency
has determined that such a requirement could actually inhibit
allegation passback as much as it could enhance it. If this
regulatory requirement were imposed such firms may take the path of
least resistance to satisfy the requirement. Basically, it would
be less of a administrative burden to file automatically any
complaint or allegation received than it would be to evaluate the
allegation, determine to whom such allegation should be sent and do
the paperwork, including keeping a copy of all this correspondence.
Added to these considerations is the fact the subjecting these
numerous processors to an alternative compliance method is still
adding substantially to the overall burden of the rule.
As a result, the Agency is not implementing an alternative
compliance method for processors solely engaged in processing
activities outside of SIC 28 and 2911. The Agency is not ruling
out the future implementation of such a provision. However, EPA
prefers at this time to support the concept of product stewardship
as previously discussed. We strongly encourage those manufacturers
and processors that are subject to the rule to educate their
customers regarding TSCA section 8(c), and to stress the importance
of passing back any potentially recordable allegations.
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From the proposed 8(c) rule amendment (49 FR 39865, 12/24/84)
III. Amendment Regarding Processors Subject to the Rule
Questions and comments received after rule promulgation
indicated some uncertainty about what processors are subject to the
rule. The current rule language under § 717.5(b)(l) reads as
follows: "A person who processes chemical substances, who is not
also a manufacturer of those substances, is subject to this Part if
such person is engaged in activities described in Standard
Industrial Classification (SIC) Major Groups 28-Chemicals and
Allied Products, and SIC code 2911-Petroleum Refining."
Most of the uncertainty revolves around the phrase "engaged in
activities described * * *." The concern is that the phrase can be
interpreted to apply to many more companies than the Agency
intended.
For example, in the manufacturer of paper cartons, the glues
and inks may be prepared by adding water or other solvents to con-
centrates purchased from other companies. Such activities con-
stitute both processing of chemical substances and the manufacture
of mixtures. This could be interpreted as an "activity described
in (SIC 28/2911)" because these codes cover such products as ready
to use adhesives and inks. The practical question is who should be
the recordholder in the case of an allegation about ill effects of
exposure to the glue or ink. For the purposes of this rule that
responsibility rests with the producer of the concentrate intended
for use as a glue or ink. EPA's intent is more clearly expressed
by putting the emphasis on end products. Processors subject to the
rule would be those who produce for distribution in commerce a
product of the type described by SIC codes 28 or 2911. Therefore,
EPA proposes to amend § 717.5(b) of the rule to read as follow:
(b) Processors. (1) A person who processes chemical substance, who is not also a manufacturer of those chemical substances a subject to this Part
if the products distributed in commerce resulting form such processing are of Ihe type described in Standard Industrial Classification (SIC) Major
Group 28 - Chemicals and Allied Products, or (SIC) code
2911-Petrolcum Refining
From the final 8(c) rule amendment (50 FR 46768, 11/13/85)
B. Amendment To Clarify Which Processors Are Subject.
Comments. Dow, in general, objected to the use of SIC codes
as a means of defining which processors are subject to the rule.
Dow contends that "establishments" and not products are described
in the SIC Major Groups. Dow states that the products listed in
the SIC manual are intended only as illustrations to describe the
results of activities which are listed within a SIC manual. Dow
recommends two alternatives to the proposed amendment. One
approach would have EPA actually list in regulation all the
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products covered by the SIC 28 and 2911 major groups without
reference to the SIC manual. The other option would be to modify
the rule.language so that it would refer to SIC code 28 and 2911
establishments and not to the products that result from activities
of these establishments. In Dow's words, there would be no con-
fusion because operators of establishments have already determined
if the establishment is within SIC major group 28 and 2911 for
regulatory purposes.
General Electric Company (GE) also commented on the processor
issue. GE stated that EPA's proposed amendment provided little in
the way of clarification. GE also criticized the use of the SIC
codes as a way of defining processors subject to the rule. In GE's
words, requiring a company to wade through the SIC manual every
time an allegation is made regarding a company product constitutes
an undue and unreasonable burden. GE recommends a simplified
method outlining who in total is subject to the 8(c) rule.
GE contends that the majority of the "processors" that EPA
intends to cover.are actually manufacturers of mixtures. The only
exception according to 'GE would be the repackagers of chemical
substances and mixtures. Therefore, GE recommends that in order to
clarify which processors are subject to the section 8(c) rule, EPA
should revise the regulatory language of § 717.5 to state that
persons subject to the rule include all manufacturers of chemical
substances and mixtures and all repackagers of chemical substances
and mixtures.
EPA's response. In finalizing the section 8(c) rule, EPA
sought to develop a way to limit and at the same time adequately
specify which chemical processors would have recordkeeping
responsibility. It was a situation similar to the coincidental
manufacturer issue where literally hundreds of thousands of
businesses could be considered chemical processors. The Agency has
to provide the processor universe with some criteria for
determining whether it is subject to the rule. Also, the Agency
needed to be able to quantify these processors for purposes of rule
burden estimation.
The Agency does not consider that it used the SIC code system
inappropriately in the context of its implementation of section
8(c) . As stated in the SIC manual, "Each establishment is assigned
an industry code on the basis of its primary activity which is
determined by it principal product or group of products, produced
or distributed, or services rendered." These code descriptions,
including representative products, provide that measure by which a
company classifies it establishments. In essence, they are what
they do.
With regard to the options recommended by Dow, EPA does not
consider the copying of the SIC products into the regulatory
language to be an improvement over the proposed amendment. The SIC
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manual is a well known and readily available standard reference.
Transcribing the product listings into the regulatory language will
not further clarify which processors are subject to the rule or
reduce the regulatory burden on industry. Dow's other recommenda-
tion to target the SIC establishments was considered by the Agency
prior to proposal of the amendment. It would be a somewhat more
simplified means of designating who is subject, but would be more
restrictive in it coverage that the Agency believes appropriate in
implementing section 8(c). The SIC code refers to an establish-
ment's "primary" activity. By adopting Dow's approach, EPA wold
lose coverage of companies or sites that engage in chemical
processing but that are classified under some other primary SIC
code. This is why the proposed amendment placed it emphasis on end
products of a site.
After careful review the Agency has determined that the GE
proposal provides a way to accomplish the goals of this proposed
amendment and remove specific dependence on SIC code listing. The
Agency agrees that the types of "sole" processors the Agency
intends to cover are those who produce and market chemical mixtures
(including solutions) and those firms that repackage chemical
substances or mixtures. This recommendation actually enhances the
regulatory language because it express the Agency's intent to cover
repackagers as processors. Such coverage is referenced only
indirectly in the current language.
QUESTION AND ANSWER DOCUMENTS
The following is from a July 1984 Question & Answer document
that was issued prior to the amendment of 8(c) which clarified
subject processors:
1. Where does "extraction" stop and "processing" begin? (From
p. 21, question 1)
Answer
Persons are exempt from the rule provided the means by which
they manufacture a chemical substance involves mining or other
solely extractive functions. This exemption applies to com-
panies or sites within a company whose sole function is mining
or extracting naturally occurring materials. EPA considers
extraction to be a primarily mechanical process such as
crushing, grinding, drying, milling, leaching, etc. These are
normal steps taken to remove raw materials from the earth, and
prepare it for distribution in commerce as a "raw material."
Operations beyond this point, such as distilling, refining,
smelting, etc. are processes of separating out marketable
fractions, and are considered processes covered by the rule.
They are in fact primary chemical manufacturing activities
that make a person subject to the rule.
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2. Does EPA consider the mixing and use of chemicals which do
not react with one another to be a "manufacture" subject to
the rule? (From page 22, Q 3)
Answer:
The mixing of chemicals is both processing of chemical
substances as well as the manufacture of mixture. In general,
mixture manufacture may be best thought of as a subset of all
processing activities. As such only mixture manufacture to
produce SIC 28/2911 type products is subject to the rule if
this is all the firm does (i.e., it is not also a manufacturer
of one or more of the chemical substances that comprise the
mixture). This differs from "manufacture" of a chemical
substance because all manufacturers of chemical substances are
subject to the rule without regard to SIC code.
3. Is a repackager of bulk .chemicals for resale considered to be
a manufacturer or a processor for §8(c) purposes? (from p.
22, Q4)
Answer;
Persons who repackage chemicals for resale are considered
processors under TSCA.
4. Is a service compound, such as a reactor cleaner, a processed
material if emptied to waste disposal? (from p. 37, Q4)
Answer:
No. In this case, the substance is not processed for
commercial purposes. Disposal-only activities do not
constitute manufacturing or processing for commercial
purposes. The only possible exception would be if the user is
also the producer of the reactor cleaner.
5. If a firm is an 8(c) manufacturer, but purchases a solvent and
uses it to manufacture another product, is an allegation con-
cerning the solvent recordable? (from p. 5, Q16)
Answer:
No, provided that the allegation specifically cites the
solvent. In such cases, the Agency strongly encourages the
company to forward the allegation to the solvent supplier.
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A July 25, 1986 "Question and Answer Summary" prepared by EPA
following a June 10, 1986 Agency-sponsored seminar on the industry
obligations under TSCA presents the following with regard to the
term processor under §8(c) of TSCA:
"Question: What processors are covered by section 8(c)?
If a firm does not manufacture a chemical but does use
the substance to make a mixture, is that firm subject to
section 8(c)?
"Answer; Processors covered by section 8(c) include
persons who are making mixtures or are repackaging
chemical substances or mixtures.
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("HEALTH AND SAFETY STUDIES")
T8CA (THE ACT)
§8(d) of TSCA states that "The Administrator shall promulgate
rules under which the Administrator shall require any person who .
. processes . . . or who proposes . . . to process . . . any
[listed] chemical subtance or mixture . . . [to submit lists and/or
copies of health and safety studies]."
CODE OF FEDERAL REGULATIONS (CFR)
Part 716 — Health and Safety Data Reporting
Subpart A - General Provisions
According to 40 CFR §716.3, the term "Process" is defined to
mean "to process for commercial purposes."
According to 40 CRF §716.3, "Process for commercial purposes"
is defined as "the preparation of a chemical substance or mixture,
after its manufacture, for distribution in commerce, with the pur-
pose of obtaining an immediate or eventual commercial advantage for
the processor. Processing of any amount of a chemical substance or
mixture is included. If a chemical substance or mixture containing
impurities is processed for commercial purposes, then those
impurities are also processed for commercial purposes."
According to 40 CFR §716.5, the persons who must report under
§8(d) include (with certain constraints) past, present, and future
processors of chemical substances and listed mixtures.
8(d) Model Rule Interpretive Guidance
The following are published questions with answers (and in
some cases statements with responses) which address the scope of
the terms "process" or processor" under the 8(d) Model Rule:
1. A person who synthesizes or manufactures a chemical
substance C from chemicals A and B as raw materials is
not a processor of chemicals A and B.
Answer
EPA disagrees. Under TSCA section 3(10), "..." (no
further response). [From "General Comments on the
Proposed 8(d) Rule" (47 FR 38780) Q # 19]
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2. Several definitions in the proposed rule differ from
earlier Agency definitions of the same term. To the
extent that the same term has been defined in earlier
regulations, it must remain unchanged in subsequent
regulations. Introduction of multiple definitions of the
same term under TSCA will guarantee confusion and
unintentional noncompliance.
Answer
The Agency agrees that, to the extent possible, it is
important to maintain common definitions. However, the
Agency is not required to use the identical definition in
all rules. In many cases, it is necessary to tailor a
definition to the specific requirements of a given rule.
To use the same definition simply because it was
previously used, can be draconian and may give rise to
confusion when viewed in the context of a given rule.
[From "General Comments on the Proposed 8(d) Rule" (47 FR
38780) Q # 21]
3. Processors should be exempt from these reporting
regulations since they are unlikely to perform the type
of studies useful in determining what chemicals need
further testing.
Answer
The Agency disagrees. Processors may have a greater
concern about the health and environmental effects of a
chemical substance being used in a certain way than the
manufacturer of the chemical. It is a good business
practice for them to know about the potential hazard of
the chemical substances they are marketing, hence, they
will often conduct health or environmental studies.
Since these studies may be oriented to discovering the
effects of a substance in its ultimate use, the Agency
feels these studies are very important for it to have
when making regulatory decisions on the chemical sub-
stances. Also, as previously stated, the Agency needs to
examine many types of studies that, taken as a whole,
might indicate the need for testing, although individu-
ally they might not indicate the need for testing. [From
"General Comments on the Proposed 8 (d) Rule" (47 FR
38780) Q # 39]
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4. Are listed chemicals that are used for cleaning metal
parts or other articles considered to be processed under
TSCA? [Question (Q) #18, 2/16/89, Q #20, 11/10/82)]
Answer
A listed substance used only to clean metal parts is not
considered to be processed under TSCA.
5. Are laboratory chemicals that are used to test manufac-
tured chemicals considered to be processed under TSCA?
[Q #19, 2/16/89, (Q #21, 11/10/82)]
Answer
No. Since these substances are not prepared for distri-
bution in commerce, they are not processed under TSCA.
6. Should studies on purchased catalysts and process sol-
vents be submitted if the catalysts and solvents are used
to produce products sold? [Q 22, 2/16/89 (Q 24,
11/10/82) ]
Answer
No. Catalysts and process solvents are used. Only
studies on substances manufactured or processed for
distribution in commerce must be submitted. Studies on
manufactured or processed chemicals containing 8(d)
listed substances as impurities are not required to be
submitted (§ 716.20(a)(9)).
The following are telephone log O&As which concerning the 8(d)
Model Rule published 9/2/82)
Q. If they used a chemical as a solvent during the
manufacture of a product, and most of the solvent
evaporates and is not in the final product, do they
report for 8(d) as a processor of the listed chemical?
Or, are they considered a user of the listed chemical and
not required to report? 9/27/82
A. In this case they are considered a user of the chemical
because it is used in the process of making the final
product and is not part of the final product.
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Q. As a user of a listed chemical, are they required to
report any monitoring data that they have collected?
9/14/82
A. No. The section 8(d) rule applies to manufacturers and
processors of a chemical substance, not to those that are
the users of the chemical substance.
Q. If they process a listed chemical for their own use, do
they have to report as a processor of the chemical?
9/14/82
A. If they process a chemical and use it themselves, they do
not report. However, if they process a chemical and then
react the product to make something distributed in
commerce, then they would report.
Q. 3M has a mixture that contains an 8(d) listed chemical in
its initial formulation, but the chemical leaves the
mixture before processing is completed. What studies
must be reported? 9/17/82
A. Since the listed chemical is not present in the end
product, it is not reportable. The listed chemical must
be in the final result to be reportable.
Q. My client buys an 8(d) listed chemical for inclusion in
paints he manufactures and sells. The 8(d) chemical is
not altered chemically during the manufacture. Is the
client a "processor" of the 8(d) chemical? 1/20/83
A. Yes. "Process for commercial purposes" includes
preparation of a chemical substance of mixture, even if
the chemical was not reacted. see 716.3(K)
Q. Under section 8(d), reporting health and safety studies,
would an intermediate used to generate another chemical
substance be reportable under the definition of
processor?
A. Yes, an intermediate used to generate another chemical
falls under the category of processing.
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The following are CSB responses (dated 1/26/90) to AEA comments
(dated 8/23/89) on a draft 8(d) "monitoring study" O&A document
concerning the term "processor":
1 (4) . Comment regarding the definition of "processor" under TSCA
section 8(d)•
The 8(d) rule incorporates the TSCA definition of "processor"
(and limits it to "commercial purposes"). 40 CFR 716.3. Persons
wishing an interpretation of whether their activities fall within
this definition may ask EPA for a determination on a case by case
basis. It should be noted that under the 8(d) rule, very few such
inquiries have been made to date.
2 (5) . Comment requesting a consistent definition of "processing"
from section 8 rule to rule.
Section 8 rules are written to accommodate potential data
users with consideration given to the burden imposed by the
information collection. It is recognized that having different
definitions of the same term may create some problems (or having
different, possibly overlapping subsets of persons subject to rules
within a larger defined set of persons). However, it would be less
appropriate to have a single broad definition of the term for all
rules where the burden can not be justified for each individual
information collection. Similarly, it would not be justified to
have a narrow definition of the term when such a definition would
eliminate EPA's access to data deemed valuable for the purpose of
a particular data gathering effort where a broader respondent
audience is clearly within the scope of EPA's data collection
authority.
3 (6) . Comment regarding applicability of the rule to toll
processing.
In situations as described in the comment where "Company A"
has Company B purchase, blend, package, and distribute a substance
which has the label of Company A on the container, Company B is a
processor under the rule and Company A is not. This interpretation
is the same as that given in the March 1989 CAIR Q&A document
referred to in your comment.
Preambles to and Rule Texts of various 8(d) Rule Versions:
Proposed Original 8(d) rule (43 FR 4073. 1/31/78)
Preamble: "For the purpose of this rule, EPA is requiring the
submission of H&S studies only from "juridical" persons; i.e.,
"persons" established by law as companies, associations, or other
entities that manufacture, process, or distribute
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chemicals.... Persons who "manufacture or process for commercial
purposes" include those who use a chemical for product research and
development, for test marketing purposes, or solely for their own
use "
Proposed Rule- Text; 730.l(b): "Manufacture or process" means to
manufacture or process for commercial purposes, which includes (1)
for distribution in commerce, including for test marketing
purposes; (2) for use as a catalyst or intermediate, (3) for the
exclusive use by the manufacturer or processor; or (4) for product
research purposes" include those who use a chemical for product
research and development., for test marketing purposes, or solely
for their own use "
Final Original Rule (43 FR 30984) (Subsequently revoked to solicit
comments on the scope of the rule, 44 FR 6099)
Preamble: ...There is also no reason to specify "for use as a
catalyst since it is included in the phrase "for use by the
manufacturer or processor...Therefore, the definition is now
consistent with that in the inventory reporting regulations." at
3098, col 2.
[Note: To me (Chris Blunck 9/6/90), this implies that the
manufacturer or processor is not necessarily processing by virtue
of its use as a catalyst. The person is already a manufacturer or
processor prior to using the catalyst. In other words, the
question of whether catalyst use is processing is not addressed
here.]
Text; 730.1(a): "Manufacture or process" means to manufacture or
process for commercial purposes, which includes (1) for
distribution in commerce, including for test marketing purposes; or
(2) for use by the manufacturer or processor, including for use as
an intermediate.
Re-proposed Original Rule (44 FR 77470)
Preamble: ".... Thus, a paint formulator placing a solvent in the
product intended for distribution in commerce is a processor (of
the solvent) as defined in TSCA." at 77472, col. 1.
"EPA interprets the term 'manufacture or process for
commercial purposes' to refer to such activities conducted in whole
or in part, for the purpose of obtaining a commercial advantage for
the manufacturer or processor. This may be distinguished from
strictly charitable or purely academic activities. TSCA places the
responsibility for gathering information in support of chemical
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regulation on those persons who will derive the commercial benefits
from those chemicals."
At 7742, col.l.
Proposed Rule Text; Process definition: [Same as .current]
Final Rule (47 FR 38780)
"Although some commenters indicated that the scope of the rule
extends beyond the "chemical industry" and would therefore increase
the number of potential number of potential processors beyond our
estimate, EPA believes that its estimates of respondents is proper
for the following reasons. First, over 85 percent of the companies
that reported for the first section 8(d) rule were concentrated in
the chemical, allied products, and petroleum refining industries.
Second, most of the comments received from companies on the
proposed rule were from companies in those industries, which EPA
believes is an indicator of the respondent population for the final
rule. Third, EPA believes that almost all of the studies performed
on the listed substances are initiated by the manufacturers or
primary processors of the substances, which is the reason EPA
exempted distributors from reporting. These companies are heavily
concentrated in the chemical, allied products, and petroleum
refining industries." (From Economic Impact discussion, at p.
38789.)
"ASBESTOS"
FINAL RULE [47 Fed. Reg. 38780, 38781 (2 September 1982)]
"EPA interprets the term 'manufacture and process for
commercial purposes' to refer to such activities
conducted, in whole or in part, for the purpose of
obtaining a commercial advantage for the manufacturer or
processor as distinguished from charitable or academic
purposes. Therefore, chemicals manufactured for product
research and development (R&D), as well as byproducts and
impurities of commercial manufacturing and processing,
are 'for commercial purposes.1
"EPA received comments saying that the Agency's inter-
pretation is wrong because these substances themselves
are not actually marketed, and, in the case of byproducts
and impurities, are not desired for the market. However,
the Agency considers it undeniable that products of
commercial endeavors are made for commercial purposes.
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"The contmenters thought that the Inventory rule exempted
reporting of byproducts, impurities, and R&D chemicals
because they were not considered to be 'for commercial
purposes.1 On the contrary, this section 8(d) rule is
completely consistent with the Inventory rule, both rules
define these chemicals as 'for commercial purposes.' The
Inventory Rule exempted such substances only because they
were hot appropriate for inclusion in the Inventory. In
this final rule the Agency has limited the potential
reach of this interpretation. A description of the
applicability of this rule to impurities, byproducts, and
R&D chemicals follows.
"(1) Impurities. Under this rule, EPA has excluded from
reporting any studies of chemicals that the person
reporting has manufactured or processed or has proposed
to manufacture or process only as impurities.
"Since the chemicals presently listed in the rule are
marketed mostly as desirable products, rather than as
impurities, EPA expects that the excluded studies will be
so few as not to justify the burden of searching for
them. However, in other circumstances, the Agency may
propose to require the excluded studies to be reported
for some chemicals.
"(2) Byproducts. It should be noted that the definition
of 'manufacture for commercial purposes' includes only
byproduct substances and mixtures that are separated from
the other substance or mixture that is being manu-
factured, processed, used, or disposed of. Other
substances that are produced as byproducts, but not
separated from the product, are impurities of the product
and are thus not covered in the present rule."
PROPOSED RULE [44 Fed. Reg. 77470 (31 December 1979)]
" . . . Section 8(f) of TSCA [15 U.S.C. 2607(f)] states
that for purposes of section 8, the terms "manufacture1
and 'process1 mean manufacture or process for-commercial
purposes. Therefore, manufacturers and processors who
are potentially subject to the requirement to submit
lists under section 8 (d) are those who manufacture or
process chemical substances or mixtures for commercial
purposes."
Id., at 77470-77471:
"On July 18, 1978, EPA promulgated a rule similar to the
one proposed in this notice [43 FR 30984]. That rule
required persons who manufacture, process, or distribute
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in commerce the chemicals on the first ITC priority list
to submit lists and copies of health and safety studies
on those chemicals. ... On September 15, 1978, Dow
Chemical Company [Dow] filed a petition for review of the
rule in the United States Circuit Court of Appeals for
the Third Circuit, Dow Chemical Company v. United States
Environmental Protection Agency, no. 78-2203. Dow's
petition challenged two provisions of that rule on the
following grounds relating to the scope of the Agency's
statutory authority. First, Dow asserted that EPA does
not have the authority to obtain studies on chemicals
manufactured or processed for research and development
purposes since it was claimed such chemicals are not
manufactured or processed for commercial purposes. . . .
Dow's challenge of EPA's interpretation of its statutory
authority was denied on August 24, 1979. The court ruled
that (i) chemicals manufactured or processed for research
and development are manufactured or processed for
commercial purposes and (ii) that the EPA has the
authority under 8(d) (2) to require persons to submit
copies of studies on chemicals that they do not
manufacture, process, or distribute."
[NOTE: EPA subsequently revoked the July 18. 1978 rule.]
Id., at 77472-77473:
"The term 'process1 is defined in section 3(10) of TSCA
to mean preparation of a chemical substance or mixture
for distribution in commerce in the same or different
form or physical state from that in which it was
received, or as part of an article containing the
chemical substance or mixture. Thus, a paint formulator
placing a solvent in the product intended for distribu-
tion in commerce is a processor (of the solvent) as
defined in TSCA.
"EPA interprets the term 'manufacture or process for
commercial purposes' to refer to such activities
conducted, in whole or in part, for the purpose of
obtaining a commercial advantage for the manufacturer or
processor. This may be distinguished from strictly
charitable or purely academic activities. TSCA places
the responsibility for gathering information in support
of chemical regulation on those persons who will derive
the commercial benefits from those chemicals.
"Chemicals manufactured for product research and
development would fall within the scope of this rule
bacause those chemicals are produced for the potential
commercial benefit of the manufacturer
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"Chemicals that occur as byproducts or impurities from
the manufacturing or processing of other chemicals are
also considered to be manufactured or processed 'for
commercial purposes' even though they may have no
commercial purpose separate from the substance, mixture,
or article to which they are incidental. See Inventory
Reporting Regulations 40 CFR 710, 4 (d) ; 42 FR 64577
(1977). The legislative history of TSCA indicates that
a broad interpretation of the term 'commercial purpose1
was intended. Specifically addressing the definition of
'for commercial purposes,' the House Committee stated:
"By use of the term 'for commercial purposes, '
the Committee does not intend to restrict
coverage to substances manufactured or pro-
cessed 'for sale.1 Any commercial purpose
such as use as a chemical intermediate in a
manufacturing process, is sufficient to bring
the manufacture or processing of a substance
within the ambit of [the Act]. H.R.Rep. No.
94-1341, 94th Cong., 2d Sess. 30 (1976).
"Chemical intermediates which never leave the manufac-
turing plant and which are not manufactured 'for sale' or
even 'for distribution in commerce1 nevertheless are
manufactured for commercial purposes. Likewise, bypro-
ducts or impurities not manufactured 'for sale1 are
considered by EPA to be manufactured for commercial
purposes.
"When a company manufactures a particular chemical
substance or mixture for commercial purposes, other
chemicals may be produced concurrently. These other
chemicals may be byproducts that are separated from the
principal commercial products and sold, used, or dis-
carded, or they may remain in the manufactured chemical
as impurities. These byproduct chemicals that are
developed for sale or use as commercial products, of
course, are manufactured for commercial purposes. EPA
interprets TSCA to mean that the discarded byproducts and
the impurities, although they may have no commercial
purpose separate from the chemical product with which
they are associated, are also manufactured or processed
for 'commercial purposes.' The Agency notes further that
a byproduct discarded by one manufacturer may be
developed for sale by another. In either case the
byproduct is manufactured for commercial purposes.
"EPA does not believe that one manufacturer should be
able to avoid listing a study on the byproduct simply
because the byproduct is discarded, since EPA believes
that many substances which occur as byproducts or impuri-
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ties may be more hazardous than the chemical substance or
mixture with which they are associated. If the Agency is
to carry out the purpose of the Act, it must obtain
studies on these materials. An example of this situation
is the case of chlorinated dioxins, highly toxic
chemicals which appear as impurities or byproducts from
the manufacture of certain halogenated phenols, such as
2 ,4 , 5-trichlorophenol and pentachlorophenol . The
chlorinated dioxins that occur as impurities are
typically carried along in the processing of the products
in which they are found. Chlorinated dioxins,
accordingly, are covered by this rule as chemicals
manufactured or processed 'for commercial purposes.111
Id., at 77475 [proposed rule language for § 716.12]:
"(f) 'Manufacture1 and 'Process' means manufacture or
process for commercial purposes.
(1) 'Manufacture for commercial purposes' means to
import, produce, or manufacture with the purpose of
obtaining an immediate or eventual commercial advantage
for the manufacturer, and includes, among other things,
such 'manufacture' of any amount of a chemical substance
or mixture,
"(i) For commercial distribution, including
for test marketing, and
"(ii) For use by the manufacturer, including
use for product research and development, or
as an intermediate.
11 (9) (2) 'Manufacture for commercial purposes' also
applies to substances that are produced coincidentally
during the manufacture, processing, use, or disposal of
another substance or mixture, including both byproducts
that are separated from that other substance or mixture
and impurities that remain in that substance or mixture.
Such byproducts and impurities may, or may not, in
themselves have commercial value. They are nonetheless
produced for the purpose of obtaining a commercial
advantage since they are part of the manufacture of a
chemical product for a commercial purpose .....
"(j) 'Process for commercial purposes' means the
preparation of a chemical substance or mixture, after its
manufacture for distribution in commerce with the purpose
of obtaining an immediate or eventual commercial
advantage for the processor. Processing of any amount of
a chemical substance or mixture is included. If a
chemical substance or mixture containing impurities is
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processed for commercial purposes, then those impurities
are also processed for commercial purposes."
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S8(e) ("NOTIFICATION OF SUBSTANTIAL RISK.")
TSCA (THE ACT)
According to §8(e) of TSCA, "Any person who . . . processes .
. a chemical substance or mixture and who obtains information
which reasonably supports the conclusion that such substance or
mixture presents a substantial risk of injury to health or the
environment, shall immediately inform the Administrator. . ."
"POLICY STATEMENT"
According to Part I ("DEFINITIONS" section) of the Agency's
TSCA §8(e) policy statement ("Statement of Interpretation and
Enforcement Policy; Notification of Substantial Risk" 43 FR 11110;
March 16, 1978), "The term 'manufacture or process for commercial
purposes' means to manufacture or process:
"(1) for distribution in commerce, including for
test marketing purposes,
"(2) for use as a catalyst or an intermediate,
"(3) for the exclusive use by the manufacturer or
processor, or
"(4) for product research and development."
NOTE: It should be noted that the above language from the 1978
TSCA §8(e) policy statement is similar to that used in the preamble
of a 1978 proposed §8(d) rule (XX FR YYYYY; January Z, 1978) cited
previously in this document.
In addition, Appendix B of the Agency's March 16, 1978 TSCA
§8(e) policy statement presents the following process/processor-
related comment and response:
"Comment 30: To what extent are 'users' of chemicals
subject to ... [§8(e) of TSCA]?
"Response: The Agency considers that many industrial
uses of chemicals actually fall within the scope of
'processing1 chemicals "
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S8(f) ("DEFINITIONS.")
T8CA (THE ACT)
§8(f) of TSCA states that for the general purposes of §8 and
its subsections (subsection (a) through subsection (e)), the term
"process" means to "process for commercial purposes."
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DEFINITIONS
OF
CHEMICAL "PROCESS," "PROCESSOR" AND "PROCESSING"
UNDER TSCA AND TSCA REGULATIONS
(8/92 Supplement to 10/90 Background Document)
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Contents
General Documents 186
§5 SNURS 188
Biotechnology 191
§6 Asbestos (Asbestos Ban and Phase Out (ABPO) Rule) 193
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GENERAL TSCA DOCUMENTS
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
August 11, 1992 OFFICE OF
PESTICIDES AND
TOXIC SUBSTANCES
Mr. David J. Hayes, Esquire
Latham & Watkins (Suite 1300)
1001 Pennsylvania Ave, N.W.
Washington, D.C. 20004-2505
Dear Mr. Hayes:
This responds to your April 23, 1992, letter on behalf of the
Motor Vehicle Manufacturers Association (MVMA) concerning EPA's
interpretation of the term "process" under the Toxic Substances
Control Act (TSCA) and the impact of that Agency interpretation on
the U.S. automotive manufacturing industry.
As explained in our meeting on June 16, 1992, your letter is
one of several inquiries the Agency has received on the coverage of
processors under our TSCA regulations. In order to address these
concerns, we are planning to solicit public comment and hold a
public meeting this Fall to provide interested parties an
opportunity to present their views on this subject. The Agency
intends to examine the issues that are of greatest concern to the
regulated community rather than attempt comprehensive evaluation,
or redefinition, of processor under TSCA. We look forward to
participation by MVMA and its member companies.
Regarding the issues raised in your letter, EPA believes that
it is better tp provide exemptions to limit coverage of processors
in individual TSCA rules rather than to narrow the broad TSCA
definition of process. Under TSCA, the term process means, in
pertinent part,
the preparation of a chemical substance . . . for
distribution in commerce ... as part of an article
containing the chemical substance . . .
TSCA §3(10), 15 U.S.C. §2602(10). This definition provides EPA
with relatively comprehensive jurisdiction, which the Agency is
reluctant to narrow. Limiting the overall scope of the statutory
definition might result in EPA missing activities that could affect
public health or the environment. Comprehensive coverage, of
course, is not necessary in all cases and, accordingly, EPA does
provide numerous exemptions in its TSCA regulations.
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MVMA's major concerns appear to relate to the coverage of
processors under EPA's TSCA regulations rather than to the
statutory definition. In the upcoming public comment process, MVMA
may wish to recommend additional exemptions to the extent it
believes the coverage in specific regulations is unnecessarily
broad. The following are a few examples of existing exemptions in
TSCA regulations that may help to focus MVMA's comments.
EPA provides, at 40 C.F.R. §704.5(a), a general exemption from
TSCA §8(a) regulations for persons who process a chemical solely as
part of an article. Under §704.210, the reporting exemptions in
§704.5 apply to reporting under the Comprehensive Assessment
Information Rule (CAIR). The Agency's most current guidance limits
this exemption to those persons who only process the article. See,
for example, EPA's response to Questions 18 and 19 in the Agency's
March 1989 TSCA Question and Answer (Q&A) document for the CAIR.
EPA states that a person who prints on plastic bags (articles) with
an ink (a reportable chemical substance) and then sells the printed
bags is a processor of the ink and is not exempt from reporting
under CAIR. However, a person who buys and further processes the
printed bags is an exempt processor for the purposes of CAIR
reporting.
Under EPA's TSCA §8(d) health and safety study reporting
regulations, persons are only required to search files of those
employees "whose assigned duty is to advise ... on the health and
environmental effects of chemicals," 40 C.F.R. §716.25. It does
not appear to be a significant, or unfair, burden to require
submission of studies likely to be located in files of employees
responsible for health and safety in MVMA member companies if those
studies were conducted on chemicals incorporated into automobiles
or other articles in MVMA facilities.
Under EPA's TSCA section 4 test rules, because chemical
manufacturers typically pass through the costs of toxicity testing
to processors by way of increased product prices, it is generally
not necessary for processors to submit either letters of intent to
initiate testing or applications for exemption from testing (40
C.F.R. §790.48(b)).
EPA appreciates the concerns of MVMA, and other industry
groups, on the need to clarify the coverage of processors under
TSCA regulations. The Agency believes that the upcoming public
comment process will significantly aid in the resolution of the
most important issues. If you have further questions on any
matters raised in this letter, please contact Mr. Frank Kover of my
Staff at (202) 260r3436.
Sincerely,
/S/
Mark A. Greenwood, Director
Office of Pollution Prevention & Toxics
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TSCA §5 "Significant New Use Rules" (SNURs)
o 2-Chloro-l,1,1,2-tetrafluoroethane
(Final SNUR published on July 22. 1992 (57 FR 3244in
"The commenter stated that EPA should define processing or
processors of P-88-1763, to clarify who would be subject to the
requirements for notification of customers of hazard communication
requirements, notification of customers of the existence of the
SNUR for P-88-1763, and records documenting such notification.
The commenter asked EPA to clarify if the listing of potential
processors in its comments would be considered processors under the
rule. The commenter also restated that the uncertainty and burden
of a SNUR applying to so many potential processors could adversely
impact the commercial utilization of P-88-1763 as a chlorofluoro-
carbon alternative.
"EPA agrees that a better description of who is subject to the
SNUR for P-88-1763 would reduce uncertainty and the regulatory
burden. Therefore, the final rule specifically describes processing
activities that would not constitute new uses under this SNUR.
First it should be noted that under § 721.45 (f) any person who
imports or processes a substance subject to a SNUR is exempt from
that SNUR if the substance is incorporated into an article before
that person receives it unless EPA identifies such articles as
subject to a specific SNUR. Therefore, once P-88-1763 is incor-
porated into appliances, air conditioners, industrial equipment, or
any other articles (except the foam insulation described earlier)
the SNUR no longer applies to persons who import or process such
articles.
"In addition, EPA has added language to the final rule to
indicate that this SNUR is not applicable to the following
categories of processors:
Processors of this substance are not subject to this
section if they only service, repair, maintain, or sell
products that contain the substance.
"This statement defines the applicability of this SNUR and is
not intended to affect the statutory or regulatory definition of
'processor' for other purposes."
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o Sulfurized Alkvlphenol
(Final SNUR published on February 6f 1992 (57 FR 4577))
"The comment provided was that the recordkeeping requirements
of § 721.125(b) and (c) were too broad and burdensome on manu-
facturers and processors. Specifically, § 721.125 (b) requires:
Records documenting volumes of the substance purchased in the
United States by processors of the substance, names and addresses
of suppliers, and the corresponding dates. Similarly, § 721.125(c)
requires: Records documenting the names and addresses (including
shipment destination address, if different) of all persons outside
the site of manufacture, importation, or processing to whom the
manufacturer, importer, or processor directly sells or transfers
the substance, the date of each sale or transfer, and the quantity
of the substance sold or transferred on such date. Given that for
P-89-708 processors may include distributors and repackagers at
thousands of individual retail and consumer sites, the commenter
questioned whether EPA intended such recordkeeping requirements.
The commenter also requires notification only if the production
volume manufactured or imported exceeds the volume specified in the
SNUR, the function of EPA recordkeeping requirements should be to
assure that manufacturers observe this limit and that records under
§ 721.125(a) would achieve this goal. In addition the commenter
noted a similar problem concerning the large number of processors
and users who would have to be notified of the SNUR requirements
under § 721.5.
"The language of § 721.125 (b) and (c) is sufficiently broad
that it could be interpreted as requiring recordkeeping by a large
number of processors at thousands of retail and consumer sites. In
the case of P-89-708 EPA agrees with the commenter that § 721.125
(b) and (c) are not appropriate. Accordingly, the final rule does
not require the recordkeeping at § 721.125 (b) and (c) . EPA does
not intend such broad recordkeeping especially in light of the
limited SNUR provisions, which require notice when a manufacturer
or importer exceeds a certain production volume or when a person
fails to provide risk notification.
"In general EPA limits only the production volume
manfuacturerd or imported when it makes the finding under TSCA
section 5(e)(l)(A) (ii)(II)(exposure based finding) that was the
basis of action for the section 5(e) consent order for P-89-708.
EPA agrees with the commnet that in cases where EPA uses only the
exposure based authority of TSCA the recordkeeping of § 721.125(b)
and (c) may be unduly burdensome. In cases where there are other
restrictions such as worker exposure, hazard communication, and
limited distribution based on an unreasonable risk finding under
TSCA EPA may still cite 721.125(b) and (c) when appropriate.
"The commenter also questioned the notification requirement in
§ 721.5 on the grounds that they could apply to a large number of
processors and users. EPA believes, however, that this will not
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occur. Section 721.5 requires manufactuers, importers, and
processors to notify each recipient of a substance subject to a
SNUR of the requirements of that SNUR. Section 721.5(a)(2)(iii)
also exempts manufactures, importers, and processors, from such
notification requirements when they can document that the recipient
cannot undertake any significant new use described in the SNUR.
Because the SNUR for P-89-708 contains only a production limit and
risk notification provisions for manufactures of importers further
notification of the SNUR requirements is not required.
"EPA will review future SNURs especially those similar to P-
89-708 that contain only a productin volume limit and risk
notification provision to ensure that appropriate recordkeeping
requirements are imposed. The recordkeeping requirements of
§ 721.125 (b) and (c) are still appropriate for some SNURs. In
addition the suggestion that recordkeeping requirements apply to a
limited number or tiers of processors may also be appropriate in
some cases."
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"BIOTECHNOLOGY"
Proposed Policy Regarding Certain Microbial Products. EPA.
49 FR 50880, December 31, 1984.
[This was finalized as the June 26, 1986 document.]
"Section 8(c). Persons who manufacture or process
microbial products that fall under the TSCA definition of
"chemical substances" should consult the final section
8(c) recordkeeping rule. 49 FR 50893."
"Section 8(e). Persons manufacturing, processing, or
distributing microbial products for TSCA purposes will be
subject to this requirement [8(e) Policy] and should
consult the policy statement to determine their
responsibilities under section 8(e). 49 FR 50893."
Statement of Policy; Microbial Products Subject to the Federal
Insecticide, Fungicide, and Rodenticide Act and The Toxic
Substances Control Act. 51 FR 23313, June 26, 1986.
[This 1986 Policy Statement is the primary document for the
TSCA biotechnology program until rules are published. This
policy is being implemented through the requirements of 40 CFR
Parts 720 and 721, as interpreted in the 1986 Policy
Statement, so that most of the definitions in those parts also
apply to microorganisms.]
"SNUR - In the unlikely event that an imminent hazard
would arise during this interim period, the Agency could
use its authority under the section 7 of TSCA to
immediately limit or prohibit the manufacture,
processing, distribution in commerce, use, or disposal of
the hazardous product. 51 FR 23329."
"In the meantime, EPA strongly encourages persons who are
planning to manufacture, import, or process pathogenic
microorganisms for non-agricultural, new environmental
uses, except those used solely for agricultural purposes,
to report their activities to the Agency and to provide
information similar to that required for a PMN for a new
microorganism. 51 FR 23329."
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"Section 8(e) - All manufacturers, processors, and
distributors of microbial products subject to TSCA,
including those involved in research and development, are
reminded of their responsibility to notify EPA
immediately of any new information which "reasonably
supports the conclusion that such substance or mixture
presents a substantial risk of injury to health or the
environment (TSCA section 8(e)). 51 FR 23331."
PACT SHEET: EPA STATEMENT OF POLICY ON MICROBIAL PRODUCTS
SUBJECT TO THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE
ACT AND THE TOXIC SUBSTANCES CONTROL ACT.
[Summarizes key provisions of June 26, 1986 FR notice,
discussed above as 1986 Biotechnology Policy Statement.]
"EPA must be notified by manufacturers, processors or
distributors of microorganisms immediately if they become
aware of any new information that suggests the
microorganisms present a substantial risk of injury to
human health or the environment. This is not a new
requirement; it applies to all substances subject to
TSCA."
Points to Consider in the Preparation and Submission of TSCA
Premanufacture Notices (PMNs) for microorganisms. July 23,
1990.
[General guidance sent by EPA to any potential PMN submitter
for biotechnology.]
"EPA must be notified by manufacturers, processors or
distributors of microorgnaisms immediately if they become
aware of any new information that suggests the
microorganisms present a substantial risk of injury to
human health or the environment. This is not a new
requirement; it applies to all substances subject to TSCA
under the section 8(e) requirement for notice of
substantial risks. (p. 2)"
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TSCA §6 "ASBESTOS"
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
February 10, 1992 OFFICE OF
PESTICIDES AND
TOXIC SUBSTANCES
R. David DiJulio, Esq.
DiJulio and Glasser
501 North Central Ave. »
Glendale, CA 91203 *G L'r''"
Re: Asbestos Ban and Phase Out RMfe/Linoleum-Type Flooring
T-J-. •'
Dear Mr. DiJulio: ^'-
».•-*.+
This letter is in response to yojtr ^letter dated January 13,
1992, concerning "linoleum-type floorimj*"* Only those products
listed in section 763.165 of the Asbestos Ban and Phase Out (ABPO)
Rule are regulated by the Rule. However, there is not enough
information in your letter for us to determine whether your
client's product is a listed product or not.
If your client's product fits within the definition of any
product listed in section 763.165 of the ABPO Rule, the product may
be regulated by the Rule. Product definitions are contained in
section 763.163 of the ABPO Rule. In particular, note that the
ABPO Rule includes at least two flooring materials, vinyl/asbestos
floor tile and flooring felt, which is used as an underlayer for
floor coverings and is sometime bonded to the floor products. 40
CFR 763.165(a). Another product category, non-roofing coatings,
also contains some flooring materials. 40 CFR 763.165(d). If your
client's product fits within the definition of either
vinyl/asbestos floor tile or flooring felt, or within any other
product definition, it may be regulated by the ABPO Rule.
In addition, be advised that on October 18, 1991, the U.S.
Circuit Court of Appeals for the Fifth Circuit in Corrosion Proof
Fittings, et al. v. EPA, No. 89-4596, vacated the ABPO Rule and
remanded it to EPA. In a subsequent clarification of its decision,
the Court stated that only new uses of asbestos and asbestos
products included in the ABPO Rule that were not being manufactured
or processed in, or imported into, the United States on July 12,
1989, when the ABPO Rule was published are still subject to the
ABPO Rule. In the next few weeks, EPA will publish a notice in the
Federal Register about the present status of the ABPO Rule in light
of the 5th Circuit Court's decision. The notice will also address
which products may still be subject to the ABPO Rule.
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The cutting that you describe in your letter would be
considered processing under the ABPO Rule. "Process" has the same
meaning in the ABPO Rule as it does in Section 3 of the Toxic
Substances Control Act (40 CFR 763.163), where it is defined as:
[T]he preparation of a chemical substance or mixture,
after its manufacture, for distribution in commerce - (A)
in the same form or physical state as, or in a different
form or physical state from, that in' which it was
received by the person so preparing such- substance or
mixture, >or'd$fid*,- as part of an article containing the
chemical sub&&SBf&£ or mixture.
7 U.S.C.A. 2
Under this d^e£inCjH.on, your client is "processing" the
flooring because it is-|||?teparing the flooring for distribution by
cutting large roll's gf ttffr' flooring into smaller portions for sale
to contractors an'd'*usej^sjsi{ This interpretation is consistent with
the purpose and in£eh|L Qf the ABPO Rule to reduce unreasonable
risks to human heal^^%uring activities involving asbestos-
containing products, because cutting can release significant
amounts of asbestos. See, for example, the discussion of
vinyl/asbestos flo'or tile in the Federal Register notice on the
final ABPO Rule. 54 FR 29492, July 12, 1989.
Therefore, if your client's product is an asbestos-containing
product that is still subject to the ABPO Rule, your client is a
processor of a regulated product under the Rule and subject to the
processing, distribution in commerce, and labeling prohibitions and
requirements found in sections 763.167, 763.169, and 763.171 of the
Rule..
If you have any questions, please contact Mike Mattheisen on
my staff at the above address (mail code TS-794) or at 202-260-
7363.
Sincerely,
/s/
John W. Meldne, Director
Chemical Control Division
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