560979501
"AGENCY
, • #
I
Proce
l- DALLAS, TEX.O'
otificatien
Review
-------
SUPPORT DOCUMENT
PREMANUFACTURE NOTIFICATION REQUIREMENTS
AND REVIEW PROCEDURES
INDEX
I. INTRODUCTION
A. GENERAL
B. SUPPLEMENTS TO THIS PROPOSAL
II. PROVISIONS OF THIS PROPOSAL
A. APPLICABILITY
1. Who Must Report
2. Chemical Substances for Which Premanufacture
Notices Must Be Submitted
B. GENERAL NOTICE PROCEDURES
C. INFORMATION SUBMITTALS
1. Notice Form Information
a. Scope of Information Requirements
b. Level of Detail
c. Information from Other Persons
d. Alternative Form Organization -
Categories
e. Information Requirements
(i) Organization of Notice Forms
(ii) Specific Information Requirements
(iii) Optional Data
2. Test Data and Other Data
a. Scope
k• Test Data in the Possession or
Control of the Submitter
c. Other Data Known to or Reasonably
Ascertainable by the Submitter
d. Data that need not be Submitted
-------
D. EPA's Processing of Notices
1. Communication Prior to Submittal of the
Premanufacture Notice
2. Acknowledgement of Receipt of Notice
3. Determination that a Substance is not Subject
to the Notification Requirement
4. Section 5(d)(2) Federal Register Notice
5. Deficient Notices
6. Extension of Notification Period
7. Supplementary Reporting Provisions
8. Supplementary Reporting —
Small Business Definition
9. Actions Under §5(e) and §5(1:) of the Act
III. MAJOR ISSUES
A. CONFIDENTIALITY
1. Substantiation of Certain Confidentiality
Claims
2. Confidentiality of Specific Chemical
Identities
3> Information on Uses of the New Chemical
Substance: Confidentiality and Substitute
Information
4. Additional Confidentiality Provisions
(With .Respect to Health and Safety Studies)
B. SIGNIFICANT NEW USE RULES (SNURs)
-------
SUPPORT DOCUMENT
PREMANUFACTURE NOTIFICATION REQUIREMENTS
AND REVIEW PROCEDURES
I. INTRODUCTION
A. GENERAL
This support document discusses technical, procedural,
and policy considerations which underlie key parts of
premanufacture rules and notice forms proposed by EPA ( FR
, January , 1979) to implement §5 of the Toxic Sub-
stance Control Act (TSCA). The organization of this document
is consistent with the format of the Preamble to the proposed
rules and forms, and complements the Preamble by providing
a more detailed discussion of key subject areas. The reader
should study the Preamble first and then refer to the discus-
sions in this document for further explanation or clarification,
as desired.
This support document describes and explains:
(A) provisions of the proposed rulemaking; (b) procedures
for premanufacture notification; (C) the organization
and contents of the notice forms, and procedures for data
submittals; (D) the notice review process; and (E) major
issues addressed during development of the premanufacture
program. EPA considers the following sections of the preamble
to contain complete and adequate treaments of their respec-
tive subjects which therefore, need not be repeated here:
-------
I. A. STATUTORY FRAMEWORK
B. PARTS OF THIS RULEMAKING
C. GENERAL APPROACH
D. INTERIM POLICY
II. B. 1. General Provisions
2- Early Notices
3- Chemical Identity
C. 1. General
D. 9. Compliance and Enforcement
III. B. TESTING FOR NEW CHEMICAL SUBSTANCES
IV. IMPACTS
V. PUBLIC PARTICIPATION
VI. PUBLIC RECORD
This Support Document addresses two issues which are
not discussed in .the Preamble. The first is an explana-
tion of EPA's intention to provide certain assistance to
manufacturers prior to notice submittal (Section II-D-1
below). The second is a summary discussion of significant
new use rules, authorized by §5(d)(2) of the Act but
deferred by the Agency for future rulemaking (See III-B below),
In addition, in this document all aspects of the general
issue of confidentiality are addressed together (See III-A
below), whereas they are discussed in several parts of the
Preamble. For a discussion of the predicted economic costs
of the proposed rules and notice forms, readers should re-
view Impact of TSCA Premanufacturing_ Notification Require-
ments , a document prepared for EPA by A.D. Little, Inc.
and available from the Industry Assistance Office. (See
"Information Contact" below.)
Although EPA has identified specific issues for review
and comment both in the Preamble and in this Support Docu-
ment, the Agency welcomes comments by interested persons on
any parts of the proposal or supporting documentation.
-------
Written comments should bear the document control num-
ber OTS-050002 and should be submitted in triplicate to the
Document Control Officer (TS-793), Office of Toxic Substances,
U.S. Environmental Protection Agency, 401 M Street, S.W.,
Washington, D.C. 20460.
FOR FURTHER INFORMATION CONTACT:
Mr. John B. Ritch, Director
Industry Assistance Office (TS-799),
Office of Toxic Substances,
U.S. Environmental Protection Agency,
401 M Street, S.W., Washington, D.C.
20460; 800-424-9065 (toll free) in
Washington, D.C. call 554-1404.
-------
B. SUPPLEMENTS TO THIS PROPOSAL
Based upon comments received during the public
comment period, EPA will revise the proposed rules and
forms and promulgate them-in 1979. After promulgation,
the Agency may further revise and supplement them in
three basic ways. First, as EPA gains experience in
implementing the premanufacture review program it may
be necessary to change the initial rules and forms them-
selves. Second, the Agency may issue administrative
interpretation to clarify or elaborate upon specific
provisions of the requirements. Finally, EPA will issue
additional rules which supplement the ones now proposed.
These three activities are discussed below, and specific
near-term rulemaking activities are identified.
Revisions to These Rules
Alterations and improvements are to be expected in
the initial phases of any new program. As EPA gains
experience in evaluating premanufacture notices and
implementing the review program, the Agency probably
will modify some of these requirements. These modifica-
tions may be made to both the rules and forms, and EPA
will follow notice-and-comment rulemaking in making any
substantive changes.
-------
Administrative Interpretations
From time to time, as EPA gains experience in
implementing these requirements and responds to repeated
questions on specific provisions, the Agency may need
to clarify or elaborate upon some provisions of the rules
and forms to facilitate public compliance with the premanu-
facture requirements. In these cases, EPA may issue admini-
strative interpretations which will explain or elaborate
on (but not substantially modify or reverse) the particular
provisions. For example, EPA periodically may revise the
listing of journals in §720.23(c), or further interpret
terms such as "technically qualified individual" and
"known to or reasonably ascertainable."
Additional Rulemakings
Several future rulemaking activities will supplement and,
in some cases, supersede the provisions of this rulemaking
In particular, commencing in 1979 EPA will issue §4 testing
rules which apply to certain categories of chemicals, includ-
ing new ones in these categories. Also, in the future EPA
will issue rules under §5(b)(4) which list specific substances
or categories of substances that present or may present
unreasonable risks, and will implement the requirement of
§5(b)(2) that additional data be submitted for such sub-
stances. (The Agency also will develop §5(h)(2) rules
governing exemptions to the requirements of §5(b)(2).)
-------
Rules under g4 and §5(b)(4) will constitute separate CFR
parts, and EPA will develop them through standard notice-
and-comment rulemaking. In addition, if appropriate, the
Agency will add provisions to Subpart C of Part 720 con-
cerning the reporting requirements of §5(b)(2).
Near-Term Activities
In addition to these future rulemaking activities,
EPA has identified and is presently undertaking certain
near-term activities that will supplement the proposed
premanufacture notification requirements.
1. EPA is developing testing guidelines which
will identify certain physical and chemical properties,
environmental fate characteristics, and health and ecological
effects; test methodologies which are appropriate for studying
such properties, characteristics, and effects; and (to
the extent possible) decision rules, criteria, and other
specific guidance concerning the circumstances under which
certain tests should be performed. During the next few
years the Agency intends to continue developing and refining
the guidelines, because it is unlikely that §4 testing rules
ever will cover categories including all new substances
and because it may be several years before a large number
of such rules are fully implemented. In the near future
EPA will publish in the Federal Register a detailed discus-
sion of the major testing issues and guidelines alternatives
considered by the Agency. Later in 1979, EPA will propose
an initial set of premanufacture testing guidelines.
-------
2. During the latter part of 1979 EPA will under-
take a major rulemaking effort to develop significant new
use rules (SNURs), both to follow selected new substances
after their production begins and to apply to certain
existing chemicals. As discussed in Part III-B of this
Support Document, SNURs and 88(a) rules are the two major
means by which the Agency will become apprised of (possible)
changes in risks due to changing exposures for both new
and existing chemicals.
-------
II. PROVISIONS OF THIS PROPOSAL
A. APPLICABILITY
This section of the Support Document contains
information which supplements Section II-A of the Preamble.
1. Who Must Report
Domestic Manufacturers
The preamble describes the reporting requirements for
domestic manufacturers. The requirements applicable to a
person who originally manufactures a substance for a purpose
which is exempt under TSCA but who subsequently decides to
commercialize the substance for purposes covered by TSCA,
are discussed below under the heading "Manufacturers and
Importers of Exempted Substances."
Manufacturers of Chemicals Solely For Export
Section II-A of the Preamble describes EPA's policy of
requiring a person who manufactures a new substance solely
for export to submit a premanufacture notice. EPA evaluated
two other options before deciding to propose this approach.
First, the Agency could exclude such a manufacturer from the
notification requirements altogether. Second, EPA could
require the person to submit a limited "premanufacture"
notice under the authority of §8(a) of the Act. Under
-------
this latter approach the Agency could follow substances of
concern with additional reporting requirements under §8(a),
or by issuing testing rules under §4.
The major advantage of the first alternative would be to
reduce burdens on exporters, at a time when national policy
favors reducing such burdens to assist in improvement of the
U.S. balance of trade. However, this advantage could be
more than outweighed by the disadvantages of increased
chemical risks to the health and environment in this
country. If a person manufactures a highly toxic new
substance solely for export, workers could be exposed and
the substance could be discharged into the environment in
dangerous quantities. Also, many of the most severe toxic
chemical "disasters" have resulted solely or in large part
from chemical manufacturing or processing activities
(including incidents involving substances such as Kepone,
vinyl chloride, and PCBs). To defer any EPA evaluation of
exported substances until after such damages have occurred
in the United States would be contrary to Congress' general
policy in enacting the premanufacture notification
requirements - i.e., that the best time to review and, if
necessary, regulate chemical substances is before
production (and any resultant harm) has begun.
-------
The second alternative, reporting requirements under
§8(a) of the Act, would apply to persons who propose to
manufacture new chemical substances solely for export.
An initial §8(a) exporter's report might include
information concerning only chemical identity, and all data
in the person's possession or control concerning the
environmental and health effects of the substance. At the
other extreme, under §8(a) EPA could require as much
information, or more, than that required for a
premanufacture notice.
The §8(a) reporting rule approach would have certain
advantages. First, §12(a) of the Act explicitly provides
that §8 requirements may be applied to substances
manufactured solely for export. Second, under §8(a) EPA
possibly could utilize a flexible, tiered reporting
approach, initially requiring limited, general information
applicable to all such substances, and subsequently re-
quiring more detailed and extensive reports on selected
substances of concern. However, reliance on §8(a) also
could have several disadvantages. First, §8(a)(l)(A) pro-
hibits EPA from imposing this reporting requirement on any
"small" manufacturer, except in very limited circumstances.
10
-------
Second, if EPA uses §8(a) and suhsuqently determines, that
it needs additional information or that testing should be
required prior to manufacture, the Agency could not utilize
the authority of §5(e) to delay commencement of manufacture
or to regulate the substance pending the development of
information. EPA could require exporters to report under
§8(a) and thereafter require testing under §4(a). But any
such testing could take months or years to require and then
perform, during which manufacture could result in harm to
health or the environment. In contrast, if a notice is
submitted under §5, EPA could extend the review period for
an additional 90 days prior to commencement of manufacture,
and in some cases the Agency could regulate a substance
under §5(e) if there is insufficient information to evaluate
its health and environmental effects.
EPA for several reasons has decided to require §5
premanufacture notices for exported new substances. First,
it will mean that for all such substances exporters must
provide the basic information which EPA needs to assess
risks and to make regulatory decisions. Second, although a
§8(a) rule (alone or in combination with a §4 rule), also
could provide much the same information about a new
substance as is available through a §5 notice, EPA would not
have the same opportunity to review exported substances
prior to commencement of manufacture. This is because
11
-------
exporters subject to §8(a) rules could begin or continue to
manufacture harmful substances while EPA assembles the
necessary data to support regulatory actions (if any).
Further, such reporting requirements would not apply to
"small" businesses, thus excluding a significant precentage
of exporters from coverage by the rules. Third, by
requiring exporters to submit premanufacture notices for new
substances, EPA would avoid a loophole in protecting the
health and environment of the United States. Finally, the
Agency anticipates that the likely cumulative impact of this
notice requirement on the industry will be minimal, because
it is probable that only a small number of new substances
are manufactured each year solely for export.
12
-------
Importers
The Preamble explains the reporting requirements for
persons who intend to import new chemical substances.
When EPA promulgated the inventory reporting
requirements (42 FR 64572, December 23, 1977) the Agency
indicated that prior to publication of the initial inventory
it would determine whether to apply §5 to new substances
imported as a part of articles. At this time, EPA is not
proposing a resolution of that issue. Thus the inventory
policy will continue, i.e., importers must submit
premanufacture notices for substances imported in bulk, or
as a part of a mixture (after publication of the revised
inventory), but not for substances imported as a part of
articles. However, as a part of this rulemaking EPA
requests comments with respect to the following questions:
1. How might EPA define classes of substances, or
types of articles containing those substances,
which may present relatively higher risks to health
and the environment as a result of their import
into the United States?
2. What burden would be imposed on an importer if he
is required to ascertain the presence of
particular substances in his imported articles?
Are there certain classes of substances, or classes
13
-------
of articles which may contain substances, for which
identification of component substances is
relatively more or less difficult?
3. How and to what extent are domestic manufac-
turers disadvantaged by the fact that persons may
import articles containing new substances
without submitting premanufacturing notices,
while domestic manufacturers must submit
premanufacture notices before producing the same
substances for incorporation into the same or
similar articles?
As the Preamble indicates, EPA is proposing in §720.2
of this rulemaking a different definition of the term
"importer" than was contained in the inventory reporting
rules. EPA intends for these proposed rules to achieve
several purposes. First, the rules should indicate which
person, among those associated with the import of a new
substance, is the one primarily responsibile for submittal
of the premanufacture notice. Second, the rules should
insure that the person designated as having primary
responsibility for submittal is the person with the most
knowledge concerning the nature and use of the substance.
Alternatively, the rules should provide a mechanism for the
submitter or EPA to obtain information about the substance
14
-------
which is known to or reasonably ascertainable by others
associated with its importance. EPA requests comments on
the extent to which the proposed definition of importer
meets EPA's goals, and how the proposed rules might be
improved in this regard.
Manufacturers and Importers of Exempted Substances
The §5(a)(l)(A) premanufacture notification requirement
applies to all persons who intend to manufacture or import a
new substance for commercial purposes. Section 5(h) of the
proposed Act and §720.13, §720.14, and §720.15 modify this
general requirement, excluding or exempting from
premanufacture notification certain substances which
otherwise would be subject to the notice requirements.
(These exclusions and exemptions are discussed under
"Substances Subject To This Part.") In particular, §5(h)(3)
of the Act provides that a person may manufacture or import
a new substance "only in small quantities . . . solely for
purposes of research and development" without submitting a
notice. Also, under §5(h)(l) a person may apply for an
exemption to manufacture a substance for test marketing
purposes without submitting a premanufacture notice. In
developing these regulations, EPA found it necessary to
define the reporting responsibilities of a person who
manufactures a substance with the intention of using it in a
15
-------
manner consistent with one of these exemptions, but who
subsequently decides to use (or sell for use) the substance
in a manner that is not exempted.
Under the terms of either a "small quantities for R&D"
exemption, or a "test marketing" exemption, a person
legitimately may manufacture or import substantial
quantities of a new substance. In the inventory reporting
rules, EPA defined "small quantities for R&D" to be those
quantities "reasonably necessary" for such R&D purposes.
The Agency recognized that different quantities of
substances may be used for research and development
purposes, in different industries or for different uses.
Also, manufacturers may request exemptions for "test
marketing" which in fact would involve large quantities of
the new chemical substances.
For various reasons, a chemical substance manufactured
under the terms of one of these exemptions may remain in the
possession of a manufacturer or importer after completion of
the R&D or test marketing activity for which it was
produced. For example, this could result from a
miscalculation of the quantities required, or if the R&D
involves testing of the production processes, and requires
miraimal consumption of the substance itself. Thus EPA must
determine whether it should require a manufacturer or
importer to provide premanufacture notification prior to
16
-------
using the substance for purposes other than permitted under
the terms of the relevant exemption. Proposed §720.10(a)(1)
concerning persons who must report, would not apply
explicitly because the person would not be intending to
manufacture the substance - he has produced it already.
Use of the substance for the non-exempt purposes
probably would be inconsistent with the terms of the
exemption, regardless of the fact that the person may not
intend to "manufacture" the substance again. Further if the
person does not intend to manufacture the substance again,
nevertheless he may intend to process it. Therefore under
proposed §720.10(a)(3) and (b)(2), if a person uses a
substance for a purpose other than that which is consistent
with his exemption, he must submit a premanufacture notice,
even if he does not intend to manufacture or import the
substance in the future.
In addition to the proposed approach, EPA evaluated two
alternatives. First, the Agency considered whether it
should allow the manufacturer to use or distribute in
commerce without restriction any quantities of an exempt
substance produced during legitimate R&D or test marketing.
One advantage of this approach would be that the substance
would not be added to the inventory, and any future
manufacturer would be required to submit a premanufacture
notice before he commences manufacture. Also, this could
avoid adding a substance to the inventory which may not be
17
-------
manufacturers again in the near future. However, this
approach would be contrary to the spirit of these
exemptions, which is to allow only limited, controlled uses
prior to premanufacture review. Further, without a notice
requirement, the manufacturer might intentionally
overproduce during the exemption period, and this practice
might be extremely difficult for EPA to detect.
The second alternative would be to require a person who
manufactures a new substance under an exemption to refrain
from any non-exempt use or distribution of the substance
until he begins manufacture again, at which time he must
submit a premanufacture notice. However, in some cases the
manufacturer might not intend to begin manufacture in the
near future, or at all. If so, his only alternative would
be to store or dispose of the new substance at additional
costs. Neither EPA nor the public would derive any
advantage from this additional burden on the manufacturer,
compared with a policy of allowing him to submit a
premanufacture notice immediately.
Finally, EPA has considered whether it should address
this issue through the use of a significant new use rule.
Such a rule could state that any non-exempt use of a
substance manufactured under terms of an exemption would be
a significant new use, requiring submittal of a
premanufacture notice. EPA has not adopted this alternative
18
-------
at this time because the Agency has not yet developed its
general policy on the use of SNURs or a full understanding
of the limits of this authority. Further, the use of
§5(a)(2) would require a separate rulemaking(s), and EPA
does not consider it either necessary or appropriate to
issue additional rules to deal with this particular problem,
Section 720.10(a)(4) and (b)(3) would address a related
point. Under these provisions, although a person commences
manufacture or import in a manner which is consistent with
an exemption, he must submit a premanufacture notice if he
intends further manufacture or import which is inconsistent
with the terms of the applicable exemption. However, a
person may dispose of a substance without being subject to
premanufacture notification.
Processors
The preamble discusses the proposed reporting
requirements for persons who do not manufacture or import
new substances, but who intend to process or use them.
19
-------
2. Chemical Substances For Which Premanufacture Notices
Must Be Submitted
"Non-Exempt Commercial Purposes"
EPA uses the term "non-exempt commercial purposes" in
various parts of the rules and in this Support Document.
The term is defined in §720.2 of the proposed rules, and
refers to those commercial purposes for a new chemical
substance for which a premanufacture notice must be
submitted. EPA developed the term basically as a shorthand
description of those exclusions from the general notifi-
cation requirements. For example, manufacture of a sub-
stance in small quantities solely for purposes of R&D
generally would be exempt; manufacture other than in small
quantities, or otherwise not in accordance with §720.14,
would be "non-exempt." Similarly, manufacture or import for
test marketing would be "non-exempt," unless EPA has granted
an exemption under §5(h)(l) of the Act and §720.15 of the
proposed rules.
Persons With a Bona Fide Intent to Manufacture A Substance -
Procedures for Information on Confidential Identities
As indicated in Section II-A-2 of the Preamble, EPA
proposes to continue to allow a person who demonstrates a
bona fide intent to manufacture a substance for a non-exempt
commercial purpose, to determine whether his substance,
20
-------
which may be within a generic name in the appendix to the
inventory, is in fact included on the inventory. However,
the proposed rules would modify the procedures developed for
the inventory in three ways.
Maintenance of confidential chemical identities imposes
a burden on persons who intend to manufacture substances
which may be included within the inventory appendix of
generic names. Such persons must either submit a
premanufacture notice for a substance which may already be
on the inventory or, in compliance with the procedures of
§720.12(b), they must submit information to EPA and await
the Agency's response (§720.12(b)(7)). EPA intends to
respond to bona fide inquiries in a minimum amount of time
to reduce the burden on the inquirers; thus the proposed
rules state that EPA will respond to such inquiries within
45 days. To meet this deadline, under proposed
§720.41(b)(3)(iii) EPA would require the original
manufacturer of a substance to submit the specified
identification information within ten days following EPA's
request for such information. Because of the nature of
this data, the burden of providing it within the allotted
time should not be great. If the original manufacturer of
the generically named substance does not provide the
requested data, EPA would place the specific identity on the
inventory without further notice.
21
-------
The other change in procedures for inquiry by persons
with a bona fide intent to manufacture should bring the
original manufacturer up to parity with the new, intended
manufacturer. The inventory rules (§710.7(b)(5)) provide
that EPA will notify the inquirer if the evidence he
provides is consistent with the fact that his substance is
the same as that already included in the inventory appendix.
This would give the new manufacturer the advantage of
knowing that the substance had been manufactured or imported
by another person, while the original manufacturer would
remain unaware of another's intent to begin manufacture.
To eliminate this disparate treatment, under proposed
§720.12(b)(4) EPA would inform the original submitter
whenever the Agency notifies the second person that his
substance is included in the inventory appendix. EPA
previously indicated that it was considering such an
approach. (Supplementary Clarification, 43 F.R. 9254,
March 6, 1978.)
EPA will inform a person who demonstrates a bona fide
intent to manufacture a substance only that the substance he
intends to manufacture is included in the inventory. EPA
will not use these procedures to answer any other requests.
A substance will be a "new chemical substance" for the
purposes of the premanufacture notice requirement until the
Agency adds it to the inventory. EPA will not answer "bona
22
-------
fide" requests for substances undergoing premanufacture
review, or for which the notification period has expired.
If a person intends to manufacture a substance which is not
yet on the inventory, but for which he believes a premanu-
facture notice may have been submitted, he should submit his
\
own premanufacture notice. Disclosure of the confidential
specific chemical identity of a substance to such a person,
prior to the addition of the substance to the inventory,
would serve no legitimate purpose.
Exemptions Considered
EPA policy with respect to exemptions for R&D and for
test marketing is discussed in the Preamble.
The Agency considered adding the category "fuels and
fuel additives" to the inventory to exempt them from the
premanufacture reporting requirements because they also are
subject to regulation under section 211 of the Clean Air Act
(CAA). However, the Agency has determined that the
authorities provided in the CAA regarding data submittals
and regulatory control are not as comprehensive as those
contained in TSCA, and that any such exemption from TSCA
would not carry out the purposes of the Act.
There are two primary differences between the
authorities provided in TSCA and those in the CAA. First,
the CAA limits EPA to taking action only when an adverse
effect on air quality results from the use of a chemical.
23
-------
TSCA is broader and authorizes the Agency to take action if
the manufacture, processing, distribution in commerce, use,
or disposal of the substance presents or will present an
unreasonable risk to health or the environment. Second,
under the CAA EPA would not be able to take action until the
fuel or fuel additive is introduced into commerce; TSCA
allows the Agency to act before manufacture begin.
EPA intends to coordinate implementation of the
authorities provided in TSCA and the CAA to minimize
reporting burdens on industry. The Agency requests comments
concerning how it may best accomplish this objective.
Co-products Used for Limited "Commercial Purposes"
Section 710.4(d)(2) of the inventory reporting rules
excludes "any byproduct which has no commercial purpose,"
from the inventory requirements. It is followed by a note
which permits reporting for certain "byproducts" with
limited commercial use as a fuel, for disposal as a waste or
for use as a raw material for the extraction of component
substances. The proposed premanufacture rules are identical
in substance to this provision, but are different in form.
The exclusion from mandatory reporting for byproducts with
certain limited uses (the note to §710.4(d)(2)) has become
proposed §720.13(d) in these premanufacture rules.
However, because of the proposed change in definition of
"byproduct," plus the proposed new definition of
24
-------
"co-product" (See §720.2), the provision now uses the term
"co-product" in place of "byproduct." The same limited
purposes included in the inventory rule are enumerated in
proposed 720.13(a).
This new provision is followed by a note based on EPA's
response to Comment 55 in the inventory reporting rules (42
FR 6458, December 23, 1977.) The note states that if a
person extracts a new chemical substance from a co-product,
he must submit a premanufacture notice. A person may
determine whether to report an extracted substance by
examining the inventory: if the manufacturer of the
substance or any other person has reported the substance for
the inventory, the extractor is not required to report.
The rules' proposed exclusion of co-products which are
used for fuels, for disposal as a waste, or for extraction
of component chemicals is consistent with the inventory
rules. However, EPA recognizes that even such limited uses
may have a potential for injury to health or the
environment. In its response to Comment 52 in the inventory
reporting rules, EPA stated its intention to require
reporting on any such substances which would be hazardous
under rules which the Agency issues under the Resource
Conservation and Recovery Act. EPA specifically requests
25
-------
comments whether this exclusion should be maintained, and if
not, how it should be modified. Persons who provide
comments should recognize the benefits that may result from
these commercial uses of co-products, and the need to avoid
imposing excessive requirements which might discourage
finding economic uses for these substances as an alternative
to disposal of them as wastes.
26
-------
B. GENERAL NOTICE PROCEDURES
How to Assert a Claim of Confidentiality
This topic is discussed in the Preamble. The
substantiation requirement contained in proposed §720.40(c)
is discussed further in Section III-A of this Support
Document. In addition, that section contains the
substantiation questions.
New Information or Data
As discussed in the Preamble, proposed §720.20(i) would
require persons who submit premanufacture notices to report
relevant information concerning the new substance which
becomes available after submittal of the notice and before
the close of the notification review period.
EPA considered alternative methods for obtaining such
new data. If the Agency does not adopt a general
requirement for the submittal of new information, it could
obtain the information either if (1) the manufacturer
voluntarily provides it to the Agency, or (2) EPA requires
submittal of the information on a case-by-case basis, using
its §8(a) reporting authority.
27
-------
With regard to the first approach, although manufacturers
may submit new information voluntarily when it would benefit
them to do so, the benefit of the information to the
submitter should not be a sole criterion for determining
which information should be submitted. In fact, EPA is
primarily interested in information which might provide
further insight concerning any risks which the substance may
present to health or the environment. If new information
provides evidence of previously unidentified risks, the
manufacturer may not voluntarily submit it to EPA because it
may not be in his best interests to do so. The second
alternative has similar disadvantages. Because of EPA's
time and resource constraints in reviewing notices, the
Agency likely could use §8(a) only with respect to those
substances which it has identified for priority review. Yet
the new information itself could be the basis for EPA's
decision to give priority attention to a particular
substance.
EPA has considered extending the time period for the
submittal of new data to run from the date a notice is
submitted until manufacture actually begins. At this time
the Agency believes that such an extension is not necessary.
This is true particularly because EPA's own review of the
new sustances in most cases will be limited to the formal
notification period. (But see proposed §720.35(c), and the
discussion in Section II-D-6 of this Support Document.)
28
-------
However, the Agency is considering extending the period for
subraittal of new data which manufacturers receive from
processors and users of new substances pursuant to
&720.20(e), to the date manufacture begins. (For a further
discussion of this issue of information from processors and
users, see II C-l-c of the Support Document.)
EPA specifically requests comments concerning the need
for submittal of new data and whether the proposed language
adequately describes the information which must be
submitted. Also, comments are invited concerning whether
the Agency should extend the time period for the submittal
by manufacturers of information which they receive from
processors and users pursuant to §720.20(e).
29
-------
Notice of Commencement of Manufacture or Import
The Preamble discusses EPA's proposed requirement that
persons notify the Agency when they begin to manufacture or
import chemical substances for which they previously
submitted premanufacture notices. This notice requirement
would ensure that the inventory will be accurate and up to
date, and would impose only a minimal reporting burden on
manufacturers and importers.
The notice will be extremely simple. EPA intends to use
a postcard format which will require only two items of
information:
- Date of commencement of manufacture or import;
and
- A coded reference number, which would enable EPA
to associate the notice with the chemical
substance for which a premanufacture notice
previously was submitted.
The code number would be used to identify the substance.
Thus the notice itself would not contain any confidential
information.
The notice would require the manufacturer or importer to
certify that he had commenced, or would commence manufacture
or import on the date indicated. He also would certify that
with respect to any claim of confidentiality previously
submitted to the Agency, the substantiation required to be
submitted is materially accurate as of the date of
30
-------
commencement of manufacture or import. The need for
certification with respect to confidentiality can be best
understood in the context of proposed §720.41(b), which
deals with the confidentiality of chemical identities after
commencement of manufacture. This section would require the
manufacturer to make and substantiate such a claim no more
than one year, but no less than 60 days, prior to
commencement of manufacture. At the time a person claims
confidentiality, he would be required to certify the
accuracy of any facts asserted in the substantiation.
However, if there has been a gap of more than one year
between substantiation of the claim and commencement of
manufacture, the facts may have changed. To complete the
certification, the submitter must review his substantiation,
revise it if there has been a material change, and submit
the revisions to EPA.
The proposed regulation states that the Notice of
Commencement must be filed no later than the day manufacture
or import actually commences. EPA will consider the notice
to have been filed on the date when the notice is
postmarked, or when the Agency receives the notice if it is
transmitted other than by U.S. mail. The notice must be
filed by every person, regardless of company size or volume
of anticipated production.
The proposed requirement for a Notice of Commencement
addresses a simple problem. Section 8(b) of the Act states
31
-------
that EPA shall add a new substance to the inventory as
of the earliest date when the substance is manufactured
(or imported) in the United States for non-exempt
commercial purposes. Manufacture or import legally may
begin at any time after expiration of the notification
period, unless EPA has acted to prohibit it. It is not
possible to calculate the actual date of commencement
on the basis of the date the premanufacture notice was
filed, or the notification period expired. Neither is
it possible for a person to predict on the
premanufacture notice form, with absolute accuracy, the
date he will in fact commence to manufacture. Thus the
issue is how EPA can determine this date.
In addition to the proposed approach, EPA
considered other alternatives for determining when the
manufacture or import of a new substance actually has
commenced.
First, the Agency could decide not to require
separate notice at all. Rather EPA could require the
submitter to indicate on his premanufacture notice form
the projected date of manufacture, and the Agency would
add the new substance to the inventory on the projected
date. The major disadvantage of this approach is the
inherent unreliability of estimated dates of
manufacture or import. Although made in good faith,
the manufacturer's or importer's estimates are based
upon a variety of factors over which he may have little
control. Further, the chance of error multiplies
32
-------
the farther in advance of manufacture that the
premanufacture notice is submitted. Reliance on these
projections could result in some substances being added
to the inventory although manufacture had not yet (and
might never) commence.
Second, EPA could permit the submitter to indicate
a projected date of commencement on his form, and
require him to submit a Notice of Commencement only if
he does not begin production on that date. This
approach might marginally reduce the reporting burden
in some cases; however, it also might increase the
burden in other situations. In particular, if a person
indicates that manufacture will begin on a given date,
but in fact it does not, he would be required to notify
EPA so that the substance would not go on the inventory
at that time, and perhaps renotify the Agency when
production or import commences.
EPA also considered requiring the person to
indicate on a "Notice of Commencement" any changes in
the projected volumes and uses of the substance which
had become known to him since he submitted the
premanufacture notice. Because he might have submitted
the notice months or years before commencement of
manufacture, the new information would be much more
accurate, and in some cases could indicate a signifi-
cant increase in the exposure expected to result from
the manufacture of the new substance. Such a require-
33
-------
ment could supplement the "new information or data" a person
would be required to submit to EPA during the notification
period under proposed §720.20(i). However, the Agency may
not need this information for all new substances, and the
increased burden imposed on manufacturers could, in many
cases, be unnecessary. If EPA determines that it needs new
or updated information with respect to a substance after
expiration of the notification period, the Agency has other
statutory authorities to focus this requirement on those
substances for which there is some basis of concern.
Included among these would be imposition of a reporting
requirement under §8(a), and establshment of a "significant
new use" rule in accordance with §5(a)(2).
EPA has decided that any person who commences production
of a new chemical substance should submit a simple,
non-burdensome "Notice of Commencement of Manufacture or
Import." This notice will ensure that the inventory of
chemical substances is kept current, and will impose only a
minor reporting burden upon manufacturers and importers.
Section 8(a)(l) of the Act states that in general EPA
may not require reporting by "small" manufacturers or
processors. However §8(a)(3)(A)(i) provides that EPA may
require that a "small manufacturer" report information
required for publication of the "first list of chemical
substances required by subsection [8(b)]."
34
-------
To the extent that the Notice of Commencement of Manufacture
is authorized by this provision, it is not necessary to
define which persons are "small manufacturers," for the
purpose of §720.52. However, even if §8(a)(3)(A)(i) does
not authorize this reporting, EPA estimates that the
requirement to submit a Notice of Commencement will impose a
negligible burden on a manufacturer or importer, and the
Agency believes that no person should be exempt from this
requirement as a "small manufacturer." EPA requests comment
on the burden that this requirement would impose.
35
-------
C. INFORMATION SUBMITTALS
As described in the Preamble, the proposed rules
establish the general contents of the forms and the
legal duty to complete them, and provide detailed
guidance on the data submittal requirements of
§5(d)(l)(B) & (C). The forms themselves specify the
information to be submitted, including that referenced
in $5(d)(l)(A). EPA is proposing for comment the
"Premanufacture Notice Form" for use by domestic manu-
facturers and the "Premanufacture Notice Form for
Importers." Proposed §720.20(e) and §720.21(c)
identify certain persons from whom the manufacturer
(and importer) must request certain information. EPA
has prepared the "Processing and Consumer Use Form" for
use by domestic manufacturers and importers, and the
"Foreign Manufacturers/Suppliers Form" for use only by
importers in contacting such persons.
EPA has considered the relative emphasis to place
in the rules and forms for detailing information
requirements. One option is to detail each specfic
reporting requirement in the rules, in regulatory
language and format. However, to duplicate in
regulatory language details of the form would not
affect their legal standing or EPA's procedures towards
36
-------
modifying them. Furthermore, to prescribe in the rules
details which do not appear in the forms would forgo
the basic advantage of using forms, which is to
organize information requirements in a logical and
understandable manner which facilitates industry's
reporting and EPA's review of new chemicals.
Therefore, EPA proposes to specify the exact reporting
requirements in the forms (and to explain the forms).
In the rules, the Agency will establish in more general
terms the contents of the forms and the legal duty to
complete them. EPA will follow general rulemaking
procedures to change the rules and forms. (However,
EPA will not publish the forms in the CFR but rather
will make them separately available at EPA offices
throughout the country.)
37
-------
1. Notice Form Information
a. Scope of Information Requirements
EPA considered several options for the scope
of information requirements specified by the rules and
notice forms. First, EPA could limit the information
required to that specifically listed in §8(a)(2). This,
however, would not provide EPA with sufficient informa-
tion for its premanufacture review. In this regard, Congress
intended the items listed in §8 (a) (2) to be "illustrative" -
and not exclusive - of the information that the Agency needs
for decision-making. (Conference Report, p. 693.)
A second option would augment the information listed
in §8(a) (2) with other information which relates to expo-
sures throughout the "life cycle" of a chemical, i.e.
manufacture, processing, distribution in commerce, use,
and disposal. In general, the 98(a)(2) list relates to
chemical exposures, including sources, amounts, and
types. By emphasizing exposure-related information, EPA
could expand upon the items in §8(a)(2) in a manner con-
sistent both with the nature and scope of those items,
and with the Agency's focus upon chemical risks.
38
-------
However, this second option may not help EPA to make
decisions concerning the reasonableness of chemical
risks. By focusing upon exposure-related information,
the Agency could overemphasize possible risks without
considering the economic and technological significance
of new substances. In turn, this could lead to EPA
decision-making which is inconsistent with the Act's
standard of unreasonable risk as a basis for regulatory
action.
The third option also would expand upon the §8(a)(2)
list for exposure-related information, but in addition
would require information which explains how and why the
submitter (or others) will control possible exposures
(e.g., engineering safeguards, industrial hygiene con-
siderations), information explaining risk assessments,
and information concerning the reasonableness of certain
risks (such as the benefits of a new substance, the avail-
ability of substitutes, and the substance's economic and
technological significance.) EPA will need such informa-
tion to regulate new chemical substances, and because of
the limited period of time available for premanufacture
review, the Agency should have ready access to it on an
as-needed basis. By including this information in the
forms and rules, EPA could ensure such accessibility.
39
-------
The primary disadvantage of this third approach
is that it may be overly burdensome and unnecessary.
EPA's screening and review will concentrate on certain
risk factors (i.e. effects and exposure), addressing
other information only for those new substances whose
risks are found to be significant and thus merit
regulatory attention. To require this other informa-
tion for all new substances could result in the submittal
of information which the Agency would not use. Also, it
is in industry's own interest to submit such information
because much of this information will be used to demon-
strate the reasonableness of risks. Thus it may not be
necessary for EPA to formally require it. Finally,
non-risk information may vary widely for different chemi-
cals and companies, and not lend itself to standardized
detailed reporting requirements and formats.
As described in the Preamble, EPA's proposed rules and
forms would implement a modification of the second approach.
Thus EPA would require submission of the specific information
listed in §8(a)(2) plus other exposure-related information, and
would encourage (but not require) submission of other rele-
vant information which the Agency may consider in determin-
ing the need for regulatory controls.
40
-------
In distinguishing between mandatory and optional
data requirements, EPA seeks to balance the types of
data and information necessary to perform risk assess-
ments, whether the information is necessary to review
all new substances or only some, and the reporting
burdens on the submitters. By making certain informa-
tion optional, EPA will reduce the reporting burden on
industry without reducing the Agency's ability to per-
form risk assessments, and will allow submitters to
report detailed information which they consider import-
ant to EPA's review of the notices.
Also as described in the Preamble, EPA proposes to
limit the scope of reporting requirements as they apply
to chemical substances manufactured solely for export,
imported substances, and related substances (e.g.,
by products, co-products).
EPA requests comments on the proposed approach
and any other approaches which may be more appropriate.
Further, the Agency requests comments on whether the
rules and forms clearly distinguish between mandatory
and optional submissions.
41
-------
b. Level of Detail
In developing the proposed forms an overriding issue has
been the level of detail which EPA should require for the
submitted information, particularly human exposure and
environmental release data. For example, general estimates
of human exposure information could be limited to reporting
the populations that may be exposed (e.g., workers, general
population exposure from use of the chemical substance and
in the vicinity of industrial sites) and an estimate of
numbers exposed. Estimates of environmental release rates
could be limited to the percent of the new substance that
may be released during normal manufacturing, processing,
use, and disposal activities.
Alternatively, detailed estimates of human exposure in
the workplace could include expected exposure levels at each
work station and detailed consumer population exposure
levels. Air pollution release estimates could include a
description of plant layouts in terms of stack locations,
building locations, and sources of fugitive emissions.
If EPA requires only general estimates of human exposure
and environmental release, this would minimize the reporting
burden on submitters. However, it also would limit
significantly the Agency's ability to assess the health and
42
-------
environmental risks associated with the new chemical
substance. EPA could review the new substance only with
respect to the general use category for which it would be
produced, e.g., use as a "chemical intermediate" or in
"consumer products." This type of review would preclude the
Agency from performing site specific, detailed exposure
assessments. Without detailed knowledge of release
parameters or sites of release, EPA could find it necessary
to assess risks repeatedly on the basis of speculative
maximum exposure conditions that may never occur.
If the information required consists of detailed,
quantified estimates, the Agency presumably could perform
sophisticated exposure modeling and risk assessments.
However, this approach may impose a significant reporting
burden on each submitter, and would emphasize the initial
conditions of manufacture, processing, distribution, and use
to an excessive degree. Further, such detailed estimates
are more likely to be speculative and uncertain, and often
may not be known to or reasonably ascertainable by the
submitter.
As described in the Preamble, the proposed notice forms
would require information in varying levels of detail, to
the extent known to or reasonably ascertainable by the
submitter. The maximum level of human exposure or the best
available discription of such exposure would be required to
be reported. Environmental release data would be required
43
-------
in order-of-magnitude ranges. This proposed approach
recognizes the uncertainties inherent in these estimates,
and would mitigate the burden of reporting such data. This
approach will enable the Agency to perform risk assessments
commensurate with the level of detail that submitters are
able to provide, and to identify potential problem areas for
further investigation during and after the notice period.
In providing comments on the proposed rules and forms,
persons may address the level-of-detail issue. If so, EPA
encourages commenters to focus on specific information
requirements, and to indicate how and why more or less
detail would affect EPA's review of notices and the
reporting burden on industry.
44
-------
c. Information From Other Persons
Under §5(d)(1) of the Act, submitters must
provide the requested information insofar as it is "known
to" or "reasonably ascertainable" by them. This limits
reporting responsibilities so that the duty to complete
notice forms will not be unreasonably burdensome. EPA has
several options for interpreting and implementing this
statutory language.
First, EPA could offer no guidance or interpretation
of this language and allow manufacturers and importers to
construe it on a case-by-case basis. Submitters would
be able to complete the notice forms in good faith to the
best of their ability. However, this may result in widely
divergent reporting between companies, and in incon-
sistencies in the Agency's review of new substances and
treatment of manufacturers.
Second, EPA could establish a legal standard for the
phrase "known to or reasonably ascertainable." This would
provide general guidance for manufacturers, but it would
not specify the information which they must submit and
how they should obtain it.
45
-------
Third, EPA could identify certain types of informa-
tion which the Agency assumes to be known to or reason-
ably ascertainable by all manufacturers. This might
remove considerable uncertainty from the notice require-
ments, and could help focus EPA's attention on the informa-
tion submitted rather than on whether other information
should have been included. However, beyond chemical
identity, production site, intended volume, and certain
other information possessed by anyone who intends to
manufacture any new substance, the types and amounts
of information which submitters may have on new substances
are quite varied. Thus due to the diversity between sub-
stances, their uses, and the companies which produce them,
it is very difficult to identify certain information which
is "reasonably ascertainable" by all manufacturers.
Fourth, EPA could establish procedures for submitters
to follow to identify and obtain information "known to or
reasonably ascertainable" by them, identifying persons
whom a submitter should contact and specifying types of
information which the submitter should request. The
Agency could treat compliance with these procedures as
minimum compliance with the Act's notification require-
ments. This would give more precise guidance to manu-
46
-------
facturers concerning their reporting responsibilities,
and in many cases would result in EPA receiving detail-
ed information about exposures resulting from processing
and use. However, this approach might apply uniform pro-
cedural requirements to widely varying reporting situations,
increasing the reporting burden in some cases without mea-
surably increasing either the scope or the detail of the
available information.
As described in the Preamble, EPA has incorporated
a combination of the second and fourth options into the
proposed rules. Proposed £720.2 defines "known to or
reasonably ascertainable," based primarily upon lan-
guage in the legislative history of the Act, (House Report,
p. 449; Conference Report, p. 693.) It provides that all
information in a person's possession or control is per se
known to or reasonably ascertainable by him. Also, it
incorporates an objective standard, so that the focus
is upon what a reasonable person in the submitter's
situation might be expected to know or obtain. Finally,
the definition limits the information covered (in addition
to that which is in a person's possession or control) to
information which he could obtain without unreasonable
burden or cost.
47
-------
Complementing this definition, §720.20(e) identifies
persons whom each manufacturer must contact concerning
their anticipated processing and uses of his new chemical
substance. They include all persons who are parties to
contracts to obtain the substance from the submitter,
plus others who have obtained a sample from him or other-
wise contacted him, and who have indicated an interest in
purchasing or obtaining the substance. They also include
persons whom the submitter has contacted or intends to
contact and who he believes will purchase the substance
from him during the first three years of commercial pro-
duction.
In two situations a manufacturer need not contact
all such persons. First, under §720.20(e)(5), if the
manufacturer identifies a significant number of such persons,
and if the information which they will provide is duplicative,
he may contact a representative sample. EPA has not defined
such terms as "duplicative" or "representative." Rather,
the Agency intends for manufacturers to interpret this
paragraph in a good faith manner on a case-by-case basis.
The Agency requests comments on this proposed policy.
Second, proposed §720.20(e)(6) states that a manufacturer
need not contact other persons whose information will not
materially add to, change, or otherwise make signifi-
cantly more complete that which he himself includes in
his notice. Taken together, these two provisions give
manufacturers considerable discretion in reducing their
responsibilities to contact others.
48
-------
EPA has considered two general approaches to defining
the information to be requested from other persons. First,
the Agency could provide only general guidance concerning
the scope of the information requested. This would allow
submitters considerable flexibility to tailor their informa-
tion requests to particular circumstances, thereby reducing
the possibility that they will obtain only general informa-
tion. However, certain necessary questions might not be asked,
and the types and levels of detail of the information
requested may be inconsistent. Also, submitters would
have to spend time and resources developing the informa-
tion requests.
The second approach, which EPA has selected, is to
specify the questions to be asked. As described in the
Preamble, EPA is specifying in a separate Processing and
Consumer Use Form the information which submitters must
request from the other persons. The Preamble further
describes the legal rights and obligations of the sub-
mitters and of these other persons.
Finally, in his notice the manufacturer must certify
his compliance with these procedures. This certification
must identify those whom he contacted. EPA considered
and rejected a requirement that the certification include
the names and addresses of all persons not contacted,
for possible use by the Agency in follow-up reporting.
49
-------
In many cases such a provision would yield information
that EPA would not use. If necessary, following receipt
of notice the Agency can require the submitter to provide
the names and addresses of those not contacted.
EPA specifically requests comments on the proposed
approach and any other approach which may be more appro-
priate; the need for the proposed definition of "known to
or reasonably ascertainable" and whether it should be
changed in any way; whether the provisions for representa-
tive sampling are appropriate; whether the respective
legal obligations and rights of the submitter and the
persons whom he contacts are clear; which persons a
manufacturer must contact and how the rules should de-
scribe them; and the need for certification or some
other indication of compliance.
50
-------
d. Alternative Form Organization - Categories
In developing the notice forms, EPA considered several
different approaches to the forms' structure and contents.
One major alternative considered differed from the proposed
form with respect to the objectives and structure of the
forms, and the kinds of information required. In this
approach EPA would have defined several categories according
to the commercial distribution, safeguards and exposures
anticipated for the new substance. The forms would require
the submitter to identify the appropriate category for his
particular substance and to provide information tailored to
that category. He would estimate the levels of human
exposure and environmental release that would not be
exceeded under normal operating and use conditions, also, he
would identify safeguards (e.g., pollution control
equipment, product design standards) that he would
implement at sites under his control to ensure that the
stated levels would not be exceeded. If he considered the
toxicity of the substance in selecting the exposure levels,
he would explain the risks that exposure at such levels may
or would present to human health and the environment.
Further, the submitter also would be required to describe
any recommendation which he would make to purchasers of the
substance concerning restriction on exposure and other
safeguards. Finally, the forms would require the submitter
51
-------
to provide actual human exposure and environmental release
estimates for the new substance. EPA would use this
information performing its ,own independent risk as-
sessments.
The objective of the "category" approach would be to en-
courage the submitter to define safe conditions for man-
ufacture and use and to provide information on such con-
ditions to EPA for its own use in reviewing the new sub-
stances. The manufacturer would select a category under
which he believes it is reasonable to expect that adverse
exposures would not occur, and perform a risk assessment for
each human exposure or environmental release situation.
Under this approach all questions would be specifically
tailored to the proposed conditions of manufacture, proces-
sing, distribution in commerce, use, and disposal of the
chemical substance. In addition, the category selected by
the submitter would indicate to EPA the immediate potential
for human exposure and environmental release of the chemical
substance. However, the applicability of the categories
would be complex, and under this approach the submitter
would have the burden of selecting the appropriate category
with its associated restrictions. Also, the Agency would
52
-------
have no assurance that safeguards proposed by the submitter
would be used by others who might manufacture or process the
chemical substance once it is on the inventory. EPA
frequently might be provided with limited data concerning
potential risks presented by the substance in situations
other than that which the submitter proposes.
As distinguished from this "category" approach, EPA's
proposed forms emphasize more clearly the objective of
obtaining the data necessary for the Agency to perform risk
assessments. They focuses upon information concerning the
potential human exposure and environmental release of the
substance, regardless of the particular conditions of
manufacture, processing, use, and disposal anticipated by
the submitter. The proposed notice forms are structured in
a manner similar to the "category" approach by organizing
questions according to the expected distribution and use
patterns of new chemical substances. However, the submitter
must complete all mandatory sections to the extent known to
or reasonably ascertainable by him. Thus EPA is better able
to make its own indendent review of new substances, because
submitters do not define the scope of the Agency's review
through the selection of exclusive categories.
53
-------
e. Information Requirements
(i) Organization of Notice Forms
The notice forms for domestic manufacturers and
importers contain three separate parts. Part I (General
Information), Part II (Risk Assessment Data) and Part III
(Risk Analysis and Optional Data). Part I is mandatory and
must be completed by each submitter insofar as the
information is known to or reasonably ascertainable by him.
Part I would require information concerning the company
name, legal incorporation and related companies, chemical
identity, estimated production volumes and marketing,
anticipated uses, transportation, and hazard warning labels
that will be provided to persons who may use the chemical
substance. Part I would also require information to be
published in the §5(d)(2) Federal Register notice and a
schematic flow diagram of the submitter's manufacturing and
processing operations to be conducted in the United States.
To be valid, every notice must include the specific chemical
identity. (See §720.34(b)(1)(x).)
Part II also is mandatory, and divided into sections
according to subject matter. Section A would require the
submitter to describe the test data submitted with the
notice, including the types of tests performed and an
explanation of any conclusions, evaluations, or assessments
he has made concerning the test data or other information
54
-------
submitted. In addition, the submitter would be required to
explain any evaluations he has made of the adequacy of test
data, as well as evaluations of the risks presented by the
chemical substance or by substances associated with its
manufacture, processing, distribution in commerce, use, or
disposal.
Section B of Part II would require information
concerning human exposure and environmental release
associated with manufacture of the new substance. This
includes information not only on the new substance, but on
certain other chemicals which are associated with its
production. The domestic manufacturer would be required to
complete this section for each site where he will
manufacture the substance. Separate sections require the
same type of information for industrial processing and use
operations, plus information concerning consumer exposure
resulting from the use of products that contain the new
substance. However, the Premanufacture Notice Form for
Importers only requires information concerning human
exposures and environmental releases that occur within the
United States. Consequently it omits the questions
concerning manufacturing operations and includes only the
processing and consumer use provisions.
55
-------
In completing Part II, the submitter must provide all of
the information and data requested that are known to or
reasonably ascertainable by him. Thus he must answer all
questions to the best of his ability, including reasonable
estimates where he does not know with factual certainty the
answers to particular questions. The submitter must
complete the processing section if he intends to process or
make industrial uses of the new chemical substance. If he
intends to manufacture consumer products containing the
chemical substance, he must complete the consumer use
section. In addition, the submitter must complete these
sections concerning other persons' processing and use
operations and concerning others' manufacture of consumer
products containing the new substance. Thus he must provide
information based upon his own knowledge of what the other
persons may or will do with the substance, and upon what is
reasonably ascertainable by him concerning their commercial
activities.
Part III is optional, but if a submitter provides any of
the information requested it must be truthful and accurate
to the best of his knowledge. Part III requests information
on health and environmental effects testing and risk
analysis, structure/activity relationships, industrial
hygiene programs, engineered safeguards, industrial process
and use restrictions, process chemistry, and economic and
other non-risk factors.
56
-------
The Processing and Consumer Use form and the Foreign
Manufacturers/Suppliers form are derived from and quite
similar to the forms for domestic manufacturers and
importers. Both are voluntary in their entirety. The
Processing and Consumer Use Form contains two Parts: Part I
— Processing Operations and Part II—General Population
Exposure/Consumer Products. These parts request the same
human exposure and environmental release information as do
the processing and consumer use sections of the forms for
domestic manufacturers and importers. The Foreign
Manufacturers/Suppliers Form also contains two parts; Part I
—General Information and Part II—Risk Assessment Data.
Part I requests the same types of information that are
included in Part I of the domestic manufacturers' and
importers' forms, and additional information concerning
production prior to importation of the substance into the
United States. Part II requests information concerning
health and environmental test data and risk analysis.
EPA requests comments on all aspects of the proposed
organization of the premanufacture notice forms, including
the use of the four distinct forms and the general scope of
the information requirements in each.
57
-------
(ii) Specific Information Requirements
The following discussion concerns the specific
information and data requirements in the four proposed
notice forms. The particular explanations apply to each of
the forms that require the type of information discussed.
Any variations in the requirements between forms (e.g.,
marketing data) also are discussed.
Identification of Manufacturer or Importer
The proposed forms request identification of the
authorized official who submits the notice, the
organization's principal place of business, and a technical
contact within the organization. In addition, each
submitter must identify other persons who may manufacture or
import the new substance under an existing or planned
arrangement with the submitter, and indicate whether the
submission contains information from these other persons.
The submitter also must indicate the date he intends to
commence manufacture or importation of the chemical
substance, and substantiate this intention if it will be
more than three years after notification. EPA needs this
information to identify the submitter and to facilitate
further communications with him. The list of "other persons
who may manufacture or import the substance" would indicate
the potential extent of production, distribution, and use of
the substance, and EPA may use it in implementing any
followup reporting activities.
58
-------
Chemical Identity
Part I would require information related to chemical
identity including chemical name, synonyms, trademarks, and
composition (e.g., impurities). EPA needs the precise
identification of a new chemical substance both to add the
substance to the inventory and to evaluate the chemical
composition with respect to which notice is submitted. To
resolve any ambiguity, the submitter would be required to
report not only the specific chemical identity, but also
information with which the identity may be verified.
The approach to specifying chemical identity of new
chemical substances continues that used in identifying
chemical substances under the inventory reporting rules.
The form provides separate formats for identifying (1) Class
1 chemical substances, (2) Class 2 chemical substances, and
(3) polymers. The submitter also would be required to
provide information on synonyms and existing or proposed
trademarks for the new chemical substance. (See
Instructions for Reporting for the Initial Inventory.)
A Class 1 chemical substance is a substance whose
composition, except for impurities, can be represented by a
chemical structure diagram (e.g., trichloroethylene,
benzene, sodium chloride). To identify a Class 1 substance
the submitter would report a specific chemical name, a
molecular formula, and a structural diagram. In addition,
he would provide the Chemical Abstracts Services (CAS)
Registry Number, if known.
59
-------
A Class 2 substance is one whose composition, except for
impurities, cannot be completely represented by a chemical
structure diagram (e.g., linseed oil, chlorinated
napthalene, tallow fatty acids). The form would require
manufacturers to identify any such substance by reporting
its specific chemical name plus certain supporting
information, including the final reaction by which the
substance is manufactured, the immediate precursor
substances, and the nature of the reaction. In addition,
the forms also would require information concerning the
composition, or the range of compositions, of Class 2
chemical substances.
In accordance with the inventory reporting rules, a
manufacturer would identify a polymer by listing those
monomers which are used at greater than 2% (by weight) in
the manufacture of the polymer. Those used at 2% (by
weight) or less may be optionally listed as part of the
polymer identity. For each listed monomer, the submitter
would indicate the range of compositions to which the notice
applies and the maximum amount of residual which may be
present. A separate question would require the submitter to
identify any other monomer present at 2% or less in the
polymer composition which has not been listed as part of the
polymer identity. EPA intends to consider such monomers in
evaluating the notice; they will not, however, be listed as
part of the polymer's identity for purposes of the
inventory. The forms also would require information
60
-------
concerning restrictions on composition which apply to the
polymer (e.g., minimum molecular weight).
The information on composition which would be required
for Class 2 substances and polymers is more extensive than
that which EPA required for identification of such
substances under the inventory reporting regulations. EPA
needs such information to evaluate the potential risks which
may be presented by new substances. For substances of
variable composition, EPA may review the submitted data to
assess the risks which may be presented by the entire range
of compositions to which the notice applies.
The proposed forms would require the manufacturer to
list impurities which he reasonably anticipates to be
present in the chemical substance as it is proposed to be
manufactured and to identify those impurities whose levels
he will control because of potential adverse health or
environmental effects. Also he would be required to
estimate the maximum level for each impurity and the maximum
total percent of impurities.
Information on the nature and amount of impurities is
necessary both to evaluate any risks which such substance
may present and to determine the need for regulatory action.
The proposed approach does not specify any analytical
requirement. Rather the submitter would identify impurities
61
-------
based upon analyses which he performs during research and
development, and upon his knowledge of reaction chemistry
and of process or quality control operations. This approach
recognizes that at the time a notice is filed samples of the
substance, as it will be manufactured for commercial
purposes, may not be available for analysis.
EPA is considering establishing a quantitative level
(e.g., .01%) above which all impurities must be reported.
In defining such a level, EPA will consider both those
levels that might be of concern to the Agency in terms of
risk to health and the environment, and the reporting burden
which such an approach might place upon manufacturers. In
general, the level of concern for any impurity depends on
toxicity and the degree of human and environmental exposure.
However, the difficulty and cost associated with analyzing a
substance to any given level is not fundamentally related to
the potential risk presented by any impurities which may be
present. Rather, it depends primarily on the nature of the
substance and its impurities, and the technical resources
available to the submitter. EPA welcomes comment on whether
a quantitative level is appropriate as a cut-off point for
identifying impurities, and what level may be appropriate.
EPA also has considered requiring reporting only of
those impurities for which the submitter possesses data
which indicate potential adverse effects. However, this
62
-------
approach would force EPA to rely solely on the individual
submitter's assessment of risk without an opportunity to
perform an independent evaluation following receipt of a
notice.
EPA solicits comments on its proposed approach to
identifying new substances. In particular, the Agency seeks
input concerning its proposed requirements for defining
composition and identifying impurities. EPA welcomes
alternatives to the approach which would permit effective
review of risks associated with impurities without imposing
unreasonable reporting burdens.
63
-------
Production, Import, and Marketing Data
The forms would require estimates of production, import,
export, and sales volumes in ranges, and a percent breakdown
of the basis for these estimates (e.g., whether the volume
estimates are based on firm orders, forecasts developed
through marketing research, or speculation.) Volume
estimates provide a general indication of a substance's
potential environmental and human exposure and thus are an
important component in risk assessments. Table 1 shows the
ranges and codes that EPA proposes for use by submitters in
reporting production, import, export, and sales volumes.
These ranges are in orders of magnitude because more precise
estimations of these volumes may not be readily determined
prior to manufacture or import of new substances. The
ranges proposed are the same ranges that were used in the
inventory reporting regulation (40 CFR 710). EPA requests
comments on the use of these ranges for reporting the
production volumes of new chemical substances and
alternative ranges that may be more appropriate.
64
-------
TABLE I
PRODUCTION AND SALES RANGES
KILOGRAMS
0 to 454
454 to 4,540
4,540 to 45,400
45,400 to 454,000
454,000 to 4.54 million
4.54 million to 22.7 million
22.7 million to 45.4 million
7 100 million to 500 million 45.4 million to 227 million
8 500 million to 1 billion 227 million to 454 million
9 Over 1 billion Over 454 million
X No manufacture or sales is planned during that year.
CODE
DIGIT POUNDS
0 0 to 1,000
1 1,000 to 10,000
2 10,000 to 100,000
3 100,000 to 1 million
1 million to 10 million
10 million to 50 million
50 million to 100 million
65
-------
The proposed forms require a summary of all uses upon
which the submitter bases his production, import, or export
estimates. This would include both the submitter's and his
customers' intended uses of the new chemical substance.
These uses would be listed in descending order from the use
that accounts for the highest volume of the new chemical
substance to that which accounts for the lowest. This would
indicate to EPA in a rather general way those uses which
may have relatively high exposure potential and which thus
may be of particular concern to the Agency. In addition,
the submitter would be required to list other possible uses.
EPA needs use information to evaluate the potential
extent of human exposure and environmental release of the
new chemical substances. Use information will identify
processing, distribution, use, and disposal operations which
the Agency can evaluate to determine the potential exposures
of the new chemical substances to humans and the
environment. For example, new substances that may come in
contact with drinking water supplies merit special
attention. Thus EPA can combine use information with other
data (e.g., production volumes, environmental fate data) to
identify potential exposure problems that may occur once the
chemical enters commercial production.
66
-------
In describing the uses of a chemical substance, the
submitter should note both its functions and applications.
A chemical's function is related to its inherent physical
and chemical properties. For example, a chemical may be an
ultraviolet absorber, a degreaser, a catalyst, or a
plasticizer - all of which are "functions" as the term is
used here. "Application" refers to the use of a substance
in particular processes or products. For example, a
chemical may be used as an ultraviolet absorber in
industrial plastic resin compounds or as a degreaser for
fabricated metal parts; in automotive maintenance; or for
surface cleaning and conditioning. In most cases each
function will have more than one application. In general,
functions and applications can be described by a single word
or phrase. (E.g., function: antifreeze, intermediate, chain
stopper (polymerization), curing agent; application: paint
and allied products, plastic forming compounds, building
construction.)
EPA currently is developing a chemical use list which
would describe uses by function and application. This
should provide a systematic terminology to facilitate
communication on chemical use, for example as a means of
reporting under §8(a) of the Act. On July 25, 1978, EPA
published in the Federal Register a request for comments
concerning the development and utility of such a list (43 FR
32222). If EPA does not have a final use list available
when it promulgates these premanufacture rules and forms,
67
-------
the Agency still intends to require reporting of use
information by "function" and "application."
Use information also is requested in other parts of the
forms (e.g., the §5(d)(2) Federal Register notice section,
the consumer exposure section). In these other sections the
use data is requested by site and is linked to potential ex-
posures that may occur. This would help to relate the types
of uses to the exposure estimates which the submitter re-
ports.
The proposed forms also request historical production
information. This would be useful to EPA in determining the
extent to which a TSCA "new" substance already has entered
commerce, and whether it has been a significant health or
environmental problem in the past. If the chemical sub-
stance has been banned or restricted by prior governmental
action, litigation, or voluntary controls (because of
adverse health or environmental effects), the submitter
would indicate this fact in his notice and provide any
pertinent information. In addition domestic manufacturers
and importers would provide information on prior production
including estimates of the total production or import
volume and of the number of years of commercialization.
68
-------
The submitter would be required to attach a copy or
reasonable facsimile of any material safety and data sheet
for the new substance, and of any hazard warning statements,
instructions, labels, and technical data sheets that he will
supply to customers. These would highlight for Agency
consideration the submitter's own concerns and precautions
concerning exposure and possible risks.
Information for the §5(d)(2) Federal Register Notice
Part II-D-4 of this Support Document describes EPA's
proposed procedures for preparing the Federal Register
notices required by §5(d)(2) of the Act. To publish this
notice within the five-day deadline established by the Act
(see proposed §720.32(a)), the forms would require, in a
separate section, all of the information necessary for the
notice. The submitter would report in this section only
that information which he does not consider confidential. In
particular, if the specific chemical identity of the new
substance is not confidential, the submitter would provide
the specific chemical name (or list of monomers in the case
of a polymer) provided in the chemical identity section of
the form. If he claims chemical identity to be
confidential, he would enter the proposed generic name.
(The Processing and Consumer Use form does not request this
information.)
69
-------
If the submitter does not claim use data confidential,
he would list the industrial and consumer uses by functions
and applications. If he claims use data confidential, he
would provide a generic description of the industrial and
consumer uses. This description would be as specific as
possible without revealing confidential information.
In addition, domestic manufacturers and importers would
report information which characterizes human exposure and
environmental release of their new chemical substances.
They would indicate the populations that will be exposed to
the substances in the United States (e.g., workers at
manufacturing or processing sites; consumers), and would
estimate the number of persons to be exposed in each
population using the ranges proposed for general population
exposure to consumer products that contain the new chemical
substance. In addition, submitters would describe the
level, duration, and frequency of the expected human
exposure. They also would estimate the percent of their
chemical substances that may be released to the environment
as a result of manufacturing, processing, use, and disposal,
This information would enable other interested persons to
identify particular substances or exposure situations of
concern.
70
-------
Schematic Flow Diagram
The proposed forms would require submitters to report a
process flow schematic diagram describing their
manufacturing and processing operations. This diagram would
indicate the types of equipment used at each step of the
process and the points of release for air, water, and solid
waste discharges. Also, the forms would require submission
of a mass balance around the process stream and a summary of
the major chemical reactions and significant side reactions
which occur during the production operations.
EPA considered making the reporting of such information
optional. However, the Agency believes than an
understanding of the manufacturing and processing operations
will aid in the evaluation of worker exposure and
environmental release estimates submitted elsewhere in the
form. The schematic flow diagram is a concise way to
describe the essential elements of such processes. It would
also assist EPA in determining whether data in the form are
complete and reasonable, and in performing independent
assessments of potential human and environmental exposures
to the new substance and to other chemicals associated with
its production.
EPA does not believe that this requirement would impose
an unreasonable reporting burden upon industry, because most
companies prepare process flow diagrams as a normal part of
the research and development cycle. While this requirement
71
-------
is mandatory for the submitter it is not included in the
Processing and Consumer Use Form. EPA could use its §8(a)
authority to require flow diagrams from such persons
following receipt of premanufacture notices.
EPA is aware that this type of information is often
highly proprietary in nature. However, the fact that
information is confidential in nature is not a valid reason
for it to be withheld from the Agency. Also, EPA will
comply fully with its own internal procedures for handling
any such confidential business information, to ensure that
it does not become available to competitors and the general
public.
The Agency welcomes comments concerning its decision to
require the submittal of these diagrams; the particular
information to be submitted on the diagrams; the levels of
detail of this information; and the applicability of this
requirement to manufacturers, processors, and users.
72
-------
Physical and Chemical PropertiesL Environmental Fate
Characteristics, and Human and Ecological Effects Data
The forms (except the Processing and Consumer Use Form)
would require each submitter to identify any
physical/chemical properties, and health or environmental
effects data that he has submitted and explain any analyses
that he has performed concerning the risk associated with
production, use, and disposal of his new chemical substance.
The forms include a table which lists certain physical and
chemical properties, environmental fate characteristics, and
human and ecological effects data which often will be
considered in assessments of chemical risks. The submitter
would indicate on this table the fact that he is submitting
data, descriptions of data, or literature citations for any
of these properties, characteristics, and effects. In
addition he would enter the name of any specific testing
techniques and methodologies which he has used. Also, he
would discuss his conclusions, evaluations, and assessments
concerning what the data reveal about each property,
characteristic, or effect. The submitter would discuss any
evaluations he has made concerning risks associated with the
manufacture, processing, distribution in commerce, use, or
disposal of his new substance, and concerning risks
presented by other substances associated with those
activities (e.g., impurities, byproducts). Finally, the
73
-------
submitter would discuss any evaluations he has made of
whether the data he has submitted are sufficient to assess
the risks associated with a particular property,
characteristic or effect.
EPA will use these assessments and evaluations to review
the submitters' risk assessment methodologies and
conclusions and set priorities for its own risk assessment
activities. Although the Agency may not be able to require
submitters to perform these assessments, once they have been
performed they must be submitted with premanufacture notices
because they constitute information which is known to or
reasonably ascertainable by the submitter.
EPA also has considered requiring submitters to explain
why they do not perform various tests for specific effects,
and to discuss their overall testing scheme rationale. This
would provide the Agency with a more complete understanding
of the manufacturer's underlying considerations. However,
at this time the EPA believes that such reporting might
impose an excessive burden upon manufacturers. Consequently
provision of such information is optional in the proposed
forms.
Worker Exposure
The forms for domestic manufacturers and importers and
the Processing and Consumer Use Form would require infor-
mation on the extent and types of worker exposure to the new
chemical substance that may occur in the United States.
74
-------
The submitter would be required to indicate the routes of
exposure that he expects will occur and to describe the
magnitude, duration, and frequency of these exposures.
Further, for different work situations the submitter would
provide the maximum expected ambient workplace
concentrations of the substance (or a description of
inhalation exposures if specific quantitative estimates are
not available), the maximum number of workers exposed to
these concentrations, and the duration of these exposures.
The submitter also would describe how these estimates were
derived. Finally, the forms request the minimum detectable
level of the substance in the air and the method of
detection used. EPA solicits comments on the proposed
approach.
Wherever estimates concerning the numbers of workers
exposed to the new chemical substance (or other substances
associated with its manufacture, processing, use or
disposal) are required they would be reported using the
ranges listed below. EPA requests comments on the use of
these ranges or other ranges that the commenter believes
would be appropriate.
75
-------
Code Number of Worker Exposed
0 <10
1 10 - 100
2 100 - 1000
3 1000 - 10,000
4 >10,000
Worker exposures are among the most significant type of
human contact with chemical substances. Both EPA and OSHA
can evaluate the information reported on worker exposure in
conjunction with toxicity data to assess possible risks to
human health. The minimum detectable level will be useful
in evaluating the analytical methods employed, including
levels of sensitivity.
Environmental Release and Disposal
The forms request environmental release information for
each emission or effluent stream at manufacturing and
processing sites located within the United States. The sub-
mitter would estimate both the maximum and average amounts
of the new chemical substance that will be discharged to the
environment, and the concentrations of these discharges (in
ranges provided in the form). Total release estimates also
would be required. (For example, air emissions from an en-
tire site would include fugitive emissions from pumps and
valves, emissions from storage and transfer opertions, and
evaporation from water effluent treatment processes.) The
submitter would describe how these various estimates are de-
rived. In addition, he would identify the name of the water
body(ies) or name and location of the publicly owned
76
-------
treatment work (POTW) to which effluents are discharged.
Further, he would be required to report the minimum
detectable level of the new chemical substance in air
emissions and water effluents, as well as the methods of
detection. The water effluent concentration provided for
the new chemical substance should be its concentration
immediately before discharge into the receiving water body
or sewer if discharges are to a POTW. If it will be
discharged in a combined effluent stream, its concentration
should be estimated from site-operating conditions that
would produce maximum average concentrations of the new
substance.
If concentrations are based on the use of pollution
control equipment, the forms would require a description of
the type of equipment, the emission or effluent streams
served, and the expected efficiency of the equipment.
Finally, the submitter would be required to identify those
degradation products that may result from the new
substance's effluent discharge and for which he knows of
data indicating potential adverse effects.
Complementing this emission and effluent data, the forms
also would require information on disposal of wastes
associated with manufacture of the new chemical substance
(including disposal of the new substance itself). The
forms would require information concerning the anticipated
77
-------
methods of disposal, the number of persons who will be
exposed to these substances and wastes during disposal
operations, the identity of disposers and disposal sites,
and the effectiveness of pre-disposal treatment of the
substances. Persons also would report in ranges concerning
the maximum amounts for disposal. For this purpose, EPA is
proposing the ranges listed below. EPA requests comments on
the use of these proposed ranges or other ranges that the
commenter considers appropriate.
CODE AMOUNT
0 <10 Ibs/yr
1 10-100 Ibs/yr
2 100-1000 Ibs/yr
3 1000-10,000 Ibs/yr
4 10,000-100,000 Ibs/yr
5 100,000-1,000,000 Ibs/yr
6 1,000,000-10,000,000 Ibs/yr
7 >10,000,000 Ibs/yr
78
-------
EPA needs environmental release estimates and disposal
information (in conjunction with information on physical and
chemical properties, fate characteristics, and effects) to
assess the potential health and ecological impacts of new
chemical substances. EPA may be able to perform detailed
exposure modeling if submitters provide specific release
estimates. Even if only gross estimates are given (e.g.,
discharge rate in kilograms per day), they would highlight
potential problem areas and may indicate the need for
followup information gathering activities. In some cases,
these estimates may provide the basis for regulatory actions
(e.g., an order for more data under section 5(e) of the
Act), where the information indicates the potential for risk
resulting indirectly from the presence of the substance or
its degradation products in the ambient environment.
In developing the forms, EPA considered requesting less
information concerning the expected releases of the new
chemical substance to the general environment (e.g., by
omitting information on stack parameters or water effluent
concentrations). However, this would preclude any exposure
modeling and would limit the possible specificity of the
Agency's risk assessments. Because the primary purpose of
§5 is to enable EPA to review risks presented by new
substances before their initial manufacture, the Agency
should obtain this information with the premanufacture
notice itself.
79
-------
General Population Exposure
EPA is particularly concerned about exposure of the new
substance to the general population, including direct
exposure resulting from the use of consumer products
containing the substance. The Agency needs several types of
information to assess adequately the extent and magnitude of
such exposure. For products intentionally containing the
new substance that will be distributed to the general
population, or to which the general population may be
exposed, the proposed forms would require the submitter to
estimate the total amount of the substance used for each
product line, the size of the consumer market population,
and the frequency, duration and magnitude of anticipated
exposures.
EPA proposes that the following ranges be used for
reporting consumer populations:
Code Number of Persons
0 <10,000
1 10,000, - 100,000
2 100,000 - 1,000,000
3 1,000,000 - 10,000,000
4 10,000,000 - 100,000,000
>100,000,000
The submitter also would provide information concerning
routes of exposure and the formulation or construction of
products. Finally, he would explain the methods for
deriving these estimates.
80
-------
Using the information requested on general population
exposure in conjunction with health effects data, EPA will
be able to assess the potential health risks associated with
specific uses of new substances by the general population.
The degree of precision in the risk assessment will depend
on the level of detail of the information submitted. If
submitters are unable to provide accurate quantitative
estimates of potential exposure, more general data may
highlight particular uses of concern. Further, in some
cases EPA expects to estimate exposure based upon the use
information provided in notices.
One alternative to this approach would be to ask for
less detailed information concerning the general population
exposure to the new substance. For example, this could be
accomplished by omitting the request for data on magnitude
and duration of exposure. However, this would severely
limit the types and accuracy of the risk assessments that
EPA could perform, resulting either in a greater dependency
on worst case assumptions or the deferral of assessments
until the data are available voluntarily.
Other Chemicals
EPA is proposing to limit the scope of the reporting
requirements concerning byproducts, co-products and other
chemicals associated with the new substance, both with
respect to the types of such substances and the data
81
-------
required. In particular, the forms would require workplace
exposure and environmental release data on certain of these
chemicals (described below) for manufacturing operations,
but do not require similar data for processing and use. To
require information on such chemicals for processing and use
could impose unreasonable reporting burdens. In particular,
if the new substance is an intermediate used in the
production of another substance(s), it may be unreasonable
to require environmental release data concerning byproducts,
co-products, intermediates, feedstocks, and impurities of
this manufacturing operation. Further, if the Agency
evaluated the large numbers of such substances associated
with processing operations, it would have fewer resources
available to assess the risks associated with the new
chemical substance itself.
EPA would require limited workplace exposure data for
such chemicals that may be present in the workplace, and
either which are listed on the NIOSH Registry of Toxic
Effects of Chemical Substances or for which health effects
data are submitted to EPA with the premanufacture notice.
The submitter would be required to identify these chemicals
and estimate the number of workers exposed to them.
82
-------
The forms would require environmental release data only
for such related chemicals for which effects data are
submitted to the Agency with the premanufacture notices or
which EPA has indicated should be reported. In particular,
the forms would require persons to report to EPA concerning
certain priority pollutants that currently are regulated or
are under consideration for regulation under TSCA or other
statutes administered by EPA. For example, these would
include vinyl chloride (Clean Air Act); PCBs (Clean Water
Act and TSCA); the 129 priority pollutants for which EPA is
developing water quality criteria and effluent guidelines
under the Clean Water Act; and hydrocarbon air pollutants
being considered for regulation under the Clean Air Act. In
addition, chemicals which EPA identifies as potential health
or environmental problems also will be included. In the
future, a list of such chemicals will be made publicly
available and regularly updated. If the submitter expects
the manufacture of the new chemical substance to result in
the release of any of the listed substances, he would be
required to estimate the amounts to be released to the
environment within a one-year period, the expected
concentration in water effluent streams, and the hourly
emission rate to the air as appropriate. The amount
83
-------
released would be reported in the ranges listed below. EPA
requests comments on these proposed ranges and other ranges
that the commenter considers appropriate.
Code Amount
0 <10 Ibs/yr
1 10-100 Ibs/yr
2 100-1000 Ibs/yr
3 1000-10,000 Ibs/yr
4 10,000-100,000 Ibs/yr
5 100,000-1,000,000 Ibs/yr
6 1,000,000-10,000,000 Ibs/yr
7 >10,000,000 Ibs/yr
The information required for substances associated with
the manufacture of the new chemical substance, while not
detailed enough to permit detailed exposure modeling, may
focus EPA's attention on areas of concern, suggest
substances for followup activity or, in some cases, indicate
substances that require regulatory action by the Agency. If
additional information is necessary EPA may obtain it on a
case-by-case basis through informal requests to the
submitter or by using the authority of §4, §5(e) or §8(a).
These limited reporting requirements for related
chemicals should reduce the reporting burden on submitters.
Further, EPA can use its own resources in the most effective
manner, by concentrating its review of associated substances
on those most likely to contribute significantly to the
risks to health and the environment.
84
-------
Transport
Transport of a chemical substance may present risks to
human health and the environment. Therefore the forms would
require a limited amount of information which will help EPA
to identify areas of concern. This includes information on
the expected modes of transportation (e.g., truck, railroad,
pipeline), because the types and nature of possible
exposures vary between modes. Several questions address the
risks to handlers and operators which the chemical
substance may present under normal operating conditions, and
to the general population in the event of spills or
accidents. In addition, the forms would require each
submitter to describe the safeguards that will be taken to
mitigate these risks. Finally, the Department of
Transportation's hazard class and shipping name are
requested to ensure that the submitter is aware of the
applicable requirements before he transports the chemical
substance.
85
-------
(iii) Optional Data
In addition to the information required by Parts I and
II, a submitter may report any other information that he be-
lieves is important for a review of the chemical substance.
Part III identifies the types of information EPA expects
would most often be useful for Agency decisionmaking.
Risk Analysis
The proposed forms would permit, but not require, each
submitter to discuss factors which he considered in de-
signing his testing and evaluation scheme. Also he may give
his analysis of the levels of risk presented by the new
chemical substance, considering various exposure conditions
and other possible mitigating factors. First, the submitter
should describe the scientific rationales which underlie the
testing scheme. Second, he may discuss any conclusions that
further testing (or other information) is unnecessary. This
could include a discussion of factors which (a) indicate
that the substance presents only a low risk to health and
the environment (e.g., structure/activity relationships be-
tween the new substance and others of known toxicities), or
which (b) may mitigate the risks presented by the substance
(e.g., engineering safeguards which will limit or prevent
releases of the substance). The submitter may discuss why
he believes the information submitted supports a reasoned
86
-------
evaluation of the health and environmental effects of the
chemical substance. Third, if any tests have indicated
that the substance presents a potential risk of adverse
health or environmental effects, the submitter may discuss
factors or information that mitigate this risk.
Finally, the submitter may identify the conditions of
maximum potential risk from his new substance and provide
an assessment of the risk under these conditions. He may
provide information which he believes demonstrates that the
risk is reasonable even under these extreme circumstances.
To identify the conditions of maximum potential risk, the
submitter should describe the circumstances of maximum ex-
posure (e.g., new uses, expanded production levels, ac-
cidental exposures), and identify those uses that affect the
most suspectible segments of the population (e.g., children,
the infirm).
When completed by the manufacturer this section should
help EPA to understand his approach to developing and
implementing his testing scheme and will provide the Agency
with the submitter's rationale for omitting certain tests
from his testing program. In addition, it will provide the
submitter an opportunity to discuss factors which he be-
lieves mitigate risk. Finally, it will allow the submitter
to demonstrate the safety of his product, even under extreme
circumstances.
87
-------
Structure/Activity Relationships
The submitter may provide information on
structure/activity relationships which he believes are re-
levant to EPA's assessment of his new chemical substance.
He may consider the demonstrated activity (physical, chemi-
cal, or biological) of chemicals that are structurally
related to his new substance to be particularly significant
for the Agency's review decisions concerning the need for
additonal data or exposure controls. Thus the form permits
him to report concerning the basis for any structure/activ-
ity relationships, the validity of such relationships, and
their contribution to the assessment of risks presented by
the new chemical substance. Structural similarity may be
based on arrangement and types of atoms in a molecule, the
overall shape and size of a molecule, and the nature and
distributions of functional groups within a molecule. For
purposes of premanufacture notification, the submitter may
consider the activity of certain compounds that are only
vaguely similar structurally, but that are very similar
physically (i.e., in terms of boiling point, vapor pres-
sure, octanol-water partition coefficient, and similar
properties).
Structive/activity (s/a) analyses could assist in the
interpretation of test data for new chemical substances.
They also can be useful as a quality assurance measure by
highlighting results that are very different from what would
be expected based on results with similar compounds.
88
-------
Further, they can be used to infer metabolic pathways for a
particular new substance, if data exist on similar compounds
but are not generated by the tests performed on the new sub-
stance. Also structure/activity analyses may indicate
the need for certain tests or measurements on the new sub-
stance. For effects testing, structure/activity analyses
can be a basis for concluding that: (1) the substance most
likely will be biologically active, and therefore should be
controlled if exposure to it may be significant; or (2) the
substance most likely will demonstrate little or no biologi-
cal activity. In either case testing may not be necessary
if the conclusions can be substantiated with a reasonable
certainty. For environmental fate testing and measurements
of physical and chemical properties, structure/activity an-
alyses sometimes can be used to make quantitative
predictions of activity, e.g., with hydrolysis studies, pH
measurements, and flammability studies.
Industrial Hygiene Programs and Environmental Safeguards
The forms would request, but not require, information
and data concerning industrial hygiene programs which either
are in place or are anticipated. Specifically, responses to
the questions would identify industrial hygiene programs and
the extent to which they are or will be developed, including
their anticipated effectiveness in reducing chemical risks
in the workplace.
89
-------
In the Federal government the Occupational Safety and
Health Administration (OSHA) and the National Institute for
Occupational Safety and Health (NIOSH) are primarly
responsible for evaluating chemical exposure in the work-
place and for requiring or encouraging industrial hygiene
activities to control such exposures. Section 9 of TSCA
authorizes coordination between EPA and these two agencies
to reduce duplicative and inconsistent regulations. Rather
than requiring the submittal of information on particular
risk-reducing measures, EPA is proposing that submission of
such information be optional. This will give chemical man-
ufacturers the opportunity to report any such measures that
they believe EPA should consider in assessing their oper-
ations.
EPA assumes that to some extent any industrial hygiene
program will reduce chemical exposure (and hence risks) as-
sociated with manufacturing operations. However, it may not
be possible to quantify the degree of such risk reductions.
Therefore EPA will consider this type of information to be a
qualitative factor in assessing health risks associated with
the manufacture of new substances. In cases where other
data are incomplete or uncertain the information from this
section may assume increased significance.
90
-------
Engineered Safeguards
The forms would request, but not require, information
concerning workplace and environmental release safeguards to
be employed at manufacturing and processing sites.
Questions include the location of the safeguards within the
production processes, how they function, expected chemical
releases which may occur if they fail, and an estimate of
the frequency of failure. In addition, the forms would re-
quest specific information on the efficiency of pollution
control equipment and redundant controls to prevent
environmental release.
Engineered safeguards may be the primary means by which
manufacturers reduce exposures, and hence risks, associated
with the production of new chemical substances. The
information provided would indicate which safeguards will be
employed at particular sites and the extent to which they
may control exposures. In addition, it may suggest ap-
propriate safeguards for use at other sites and by other
manufacturers or users. To assess these risk reductions,
EPA needs specific information concerning how these
safeguards function. Simply to say that all aspects of a
process are controlled does not provide adequate information
for a risk assessment. For example, "control" could mean
that an operator will shut down a pump if he notices that a
storage tank is overflowing. In general, EPA does not con-
sider this to be an effective safeguard. An example of an
91
-------
appropriate way to discuss engineered safeguards would be "a
high level alarm with an automatic interlock on the pump."
Submitters should consider this example when they describe
safeguards associated with production, processing, and pol-
lution control equipment. They also should describe other
types of safeguards such as special construction materials
and product designs.
Information Concerning Industrial Process and Use
Restrictions
Many chemical substances are manufactured for exclusive
and highly specialized industrial use and consumption (e.g.,
chemical intermediates and catalysts). Other substances are
manufactured and processed under the exclusive control of
single companies. Because of their exclusive use and con-
trol within the industrial environment, these types of sub-
stances may present lower risks than substances that are
utilized by many persons for a variety of industrial and
consumer products and uses. The proposed forms would permit
submitters to provide information bearing on EPA's as-
sessment of such substances. Submitters would be asked to
describe any exclusive and specialized uses to which they
will limit their new substances, as well as any factors as-
sociated with such uses that will affect types and levels
92
-------
of exposures. For example, highly reactive chemical sub-
stances used solely as intermediates may be completely con-
sumed in the reaction processes or efficiently removed from
effluent streams by existing control equipment. In general,
information of this type will augment the exposure data re-
ported in the mandatory parts of the form.
Non-Risk Factors: Economic and Non-Economic Benefits
In assessing whether a new substance presents or will
present an unreasonable risk of injury to health or the
environment, EPA will evaluate various non-risk factors
associated with production and use of the substance. The
Agency will evaluate these factors relative to the potential
risks associated with the substance. Non-risk factors could
include both economic benefits and such non-economic
benefits as improved public health and safety and possible
environmental benefits. In particular, the proposed forms
would request an estimate of the gross market value of the
new chemical substance plus the effect of commercialization
of the new substance on the price and production volume of
existing substances and products. In addition, information
would be requested concerning employment effects, plant and
capital equipment outlays, balance of trade impacts, and the
availability of substitute chemicals. Finally, the forms
would request information on any benefits associated with
93
-------
the new chemical substance, including increased product re-
liability, public health and safety, and energy and natural
resource conservation.
The gross market sales value of a chemical substance is
the single most important index of direct economic benefits
from production. Gross market value is a measure of the
value which consumers attach to the use of the substance.
Information on the effects of the new chemical on the prices
or production volumes of other chemicals provides a general
measure of the types and extent of economic changes which
may result from availability of the new substance.
In addition, EPA may balance this information with the gross
market value of the substance to determine the net economic
benefits that may occur.
Just as gross market value is a measure of direct ec-
onomic benefits expected over the short term, investment in
plant and equipment is a measure of long term economic be-
nenfit. Such investment reflects the manufacturer's belief
in the continued viability of the substance and indicates
possible sources of further employment. The impact on bal-
ance of trade is significant because of its possible effects
on the value of the dollar and the overall strength of the
national economy.
94
-------
In evaluating the reasonableness of chemical risks, EPA
will give particular consideration to the availability of
any substitutes for new substances. Thus manufacturers may
provide information on existing substitutes which EPA will
use to estimate the expected marginal net benefits to con-
sumers from production of the new substances. In its as-
sessment of risks and benefits, EPA must consider the extent
to which the new substance has uses or properties that ex-
isting substances do not provide and how it otherwise re-
presents an improvement over existing substances. The
Agency also will consider the extent to which the new sub-
stance provides health and safety benefits that are not
available from existing chemicals.
95
-------
2. Test Data and Other Data
a. Scope
The Preamble describes the requirements of proposed
§720.23 concerning test data in the possession or control of
the submitter, and other data that are known to or rea-
sonably ascertainable by him. This section is derived from
§5(d)(l)(B) and (C) of the Act. Proposed §720.23 would
require each manufacturer to submit: (1) the complete
reports and studies for test data in his possession or
control; (2) descriptions of any other (non-test) data in
his possession or control (e.g., data concerning
structure/activity relationships); and (3) descriptions of
any data (test data or otherwise) not in his possession or
control but known to or reasonably ascertainable by him.
The Agency anticipates that most test data submittals will
be full reports, rather than descriptions of data, because
manufacturers probably will attempt to bring all test data
relevant to their new substances within their possession or
control.
Comments already received have indicated that EPA
should restrict the term "test data" to data from formal,
designed studies, so as to exclude data from informal
studies or tests. This approach could reduce the
manufacturer's reporting burden. However, much relevant
96
-------
data (e.g., monitoring data on worker exposure, recorded
observations entered in researchers' medical records)
thereby might not be reported, although such data would be
necessary to the Agency's evaluation of a new chemical
substance. Therefore the proposed definition of "test data"
includes both formal and informal tests. The Agency
requests further comment on this proposed definition.
EPA's proposed definition of "health and safety study"
in §720.2 clarifies the Agency's interpretation that tests
for which data are submitted under §5(d)(l)(B) are the same
as health and safety studies. In addition, the definition
of "health and safety study" includes studies of the
physical and chemical properties of substances. Such
studies often yield information and data regarding transport
of substances through the environment. Further, they are
integral parts of overall testing schemes and often directly
influence decisions concerning whether to test and, if so,
the selection of test methods.
In the future, EPA will propose testing guidelines, to
indicate the types and extent of data which are necessary
for an assessment of risks presented by new chemical
substances. In addition, the Agency will promulgate testing
rules under §4 to require the development of data with
respect to the health and environmental effects of specific
97
-------
categories of chemicals. Once issued, the rules and
guidelines will focus manufacturers' attention on tests for
certain effects and properties and for specified
methodologies and protocols. Further, §5(b)(l) of the Act
requires that if a §4 testing rule applies to a particular
new chemical substance, the data must be submitted prior to
(or with) the premanufacture notice. However, irrespective
of the guidelines and §4 rules, manufacturers must submit
all test data in their possession or control, and
descriptions of any other data known to or reasonably
ascertainable by them.
b. Test Data in the Possession or Control of the
Submitter
The Preamble describes the proposed requirements of
§720.23(a) concerning test data in the submitter's pros-
session or control. EPA's proposed definition in §720.2 of
"possession or control" contains a number of provisions
which specifically identify persons or organizations related
to the manufacturer and whose information or data EPA
presumes to be in the submitter's possession or control.
The Agency in particular realizes that large corporations
with many subsidiaries may not freely exchange data
internally or on all subjects. Therefore the proposed rules
would require submitters to submit only those test data
that are in the possession or control of subsidaries or
parent companies associated with the submitter in the
98
-------
marketing of the substance. EPA considers any research and
development facility within a corporate structure to he
asociated. with the R&D activities of the submitter if the
submitter derives any benefit from the facility. EPA
believes that whatever additional administrative burden this
approach may impose on large firms with complex corporate
structures and contractual relations is outweighted by the
Agency's need for sufficient data to conduct its evaluation
of new substances.
EPA proposes to require manufacturers to submit full
reports concerning test data relevant to certain health
effects, ecological effects, physical and chemical
properties, and environmental fate characteristics listed in
§720.23(a)(3) of the proposed rules. In an effort to
minimize the reporting burden on industry, the Agency
considered requiring the submittal only of abstracts of
test data. If necessary, after reviewing the abstracts EPA
could require the notifiers to submit full reports and thus
allow the Agency to conduct more thorough analyses of the
data. However, EPA only has 90 days in which to review
notices and to initiate actions to ban or limit
manufacture, use, or disposal. Thus the Agency must have
99
-------
immediate, assured access to full reports for most
properties and effects, and not just abstracts of most test
data.
To mitigate possible reporting burdens of this re-
quirement, §720.23(a)(5) would allow submitters to provide
abstracts for any data not listed in §720.23(a) (3) , provided
they agree to submit full reports upon request by EPA.
Effects and properties not listed in §720.23(a)(3) are not
likely to be of primary importance to the Agency's evalua-
tion of new substances. However, EPA would have ready
access to the reports because the submitters would agree to
provide them to the Agency upon request. The Preamble
describes other requirements concerning published reports
and incomplete studies. The Agency requests comments on
these proposed requirements.
Under §5(d)(l)(B), EPA is authorized to prescribe the
form and manner for the submittal of data with premanu-
facture notices. In the future the Agency will publish
guidance on the form of test data submittals, "Formats for
Data Submittal Under the Toxic Substances Control Act."
Without such guidance, the organization and extent of the
test data reported may vary significantly among manufac-
turers. Use of these formats will facilitate EPA's review
of premanufacture notices, including the use of electronic
data processing techniques.
100
-------
Pending publication of these formats, the following
'interim guidance applies. In general, a full report on the
effects and properties listed in §720.23(a)(3 ) should
include the following parts: abstract, introduction,
experimental methods and materials, results, discussion of
data analyses, conclusions, and references. Briefer reports
may be appropriate for certain effects. In particular, a
report of one or two paragraphs should be submitted for the
following measurements: boiling/rnelting/sublimation points,
pH, dissociation constant, flammability, explodability,
density, olfactory threshold, particle size, and
corrosion/redox potential. In addition, tables and graphs
of data should be submitted for particle size measurements.
For test data other than those listed in §720.23(a)(3) ,
abstracts should be submitted which briefly describe the
purposes, methodology, results, and conclusions of the
study.
c. Other Data Known to or Reasonably Ascertainable by
the Submitter
The Preamble describes the proposed requirements of
$720.23(b) concerning other data known to or reasonably
ascertainable by the submitter, including data known by
certain of the submitter's employees or other agents. To
101
-------
ensure that any data known by these employees or agents are
submitted with premanufacture notices, the submitter will
need to institute procedures which assure that his em-
ployees and agents have the opportunity, and are aware of
the obligation, to report any data regarding the health and
environmental effects of the new substance. (The submitter
may wish to implement these procedures in conjunction with
those prescribed by the Agency's policy statement concerning
§8(e) notices of substantial risk (43 FR 11110)). To
evaluate the adequacy of the submitter's procedures for
complying with proposed §720.23(b), paragraph (b)(4) would
require each submitter to provide with his premanufacture
notice a brief description of his procedures for identifying
data that are known to or reasonably ascertainable by him.
EPA considers structure/activity analyses to be "other
data" under §5(d)(l)(C); therefore submitters must provide
any available descriptions of such analyses. The Agency
also is considering a reporting requirement for the
submittal of data used in such analyses, and for other data
on structurally similar compounds in certain circumstances.
The Agency specifically requests comment concerning whether
it should require submission of structure/activity analyses
in the following situations:
1). If data for a particular effect or property do not
102
-------
exist for the new substance, but do exist for structurally
related chemicals;
2). If effects data for the new substance show no
cause for concern, but data for structurally similar
substances do indicate possible adverse effects;
3). If environmental fate test data for a new
substance are significantly different from such data on
structurally similar compounds; or
4). Any of 1), 2), or 3) above, but limited to data
for those structurally related substances which have been
subject to structure/activity analyses.
d. Data that need not be Submitted
Proposed §720.23(c) specifies the general exemptions
from these data submittal requirements. These include a
provision (paragraph (c)(l)) allowing manufacturers to
submit standard literature citations for data which appear
in periodicals listed in Appendix I of the rules. The
Agency requests comments on these proposed exemptions.
In rules published under §8(e) (March 16, 1978, 43 PR
11110) and §8(d) (July 18, 1978, 43 FR 30984), EPA has
stated that persons need not submit certain information if
the information is referenced in specified data bases (e.g.,
Geological Abstracts, Chemical Abstracts). The Agency
considered, but has not adopted, a similar exemption from
103
-------
these premanufacture information requirements. EPA believes
that the overall reduction in reporting burden of such an
exemption may not be substantial for purposes of premanu-
facture notification, because the published literature will
not be extensive for most new substances. Further, such an
exemption would delay EPA's review of notices because the
Agency would have to search the data bases, identify the
data which should be examined, and acquire the full journal
articles. Also, references to relevant test data may not
appear in the output of the search, which is dependent on
the search method (e.g., "key word," "substructure search,"
"molecular formula"). Finally, EPA's proposal in
§720.23(c)(1) would cover much relevant published
information.
104
-------
D. EPA'S PROCESSING OF NOTICES
1. Communications Prior to Submittal of the Premanufacture
Notice
Communications between a person who intends to
manufacture or import a new chemical substance and EPA can
and, in many cases, should begin prior to submittal of the
premanufacture notice. The rules explicitly propose
procedures for certain pre-notice discussions.
Section 720.12(b) outlines procedures under which a
person with a bona fide intent to manufacture a chemical
substance which is not listed in the inventory by its
specific identity may ascertain whether the substance is
included within a "generic" name in the appendix of
confidential identities. In addition, §720.41(a) states
that a person should consult with EPA if he intends to claim
confidentiality for specific chemical identity or use
information for the period prior to commencement of
manufacture. Ideally, this consultation would take place at
least 60 days prior to the submittal of the premanufacture
notice, to ensure that an acceptable generic name is
developed and that key exposure and test data be reported
for the Federal Register notice of receipt of the
premanufacture notification.
105
-------
Other pre-notice consultation may be appropriate whether
or not information is claimed confidential. For example, a
person who intends to manufacture a substance whose identity
cannot be defined by molecular formula (i.e., a "Class 2"
substance) may require an Agency opinion whether the
substance is listed on the inventory. If his substance is
new, he may require assistance in determining an acceptable
name.
It is not possible at this time to specify all of the
technical questions which may be resolved by communications
prior to submittal of notices. However it will be of
advantage both to notice submitters and to EPA to resolve
problems which could delay the Agency's evaluation of the
notices. Such delays could lead to extensions of the notice
periods or to a need to remedy deficiencies in the notices.
One form of pre-notice consultation is neither autho-
rized by the law nor appropriate - consultation which would
give a manufacturer or an importer a definitive pre-
notice determination of whether his a chemical substance, as
he intends to manufacture or use it, will be regulated by
EPA. The Agency recognizes that manufacturers may have
legitimate needs for determinations as early as possible of
the likelihood of regulation to avoid disruptions in
106
-------
business or of investment decisions. However, several
provisions of the Act, including §5(d)(2) (Federal Register
notice), §14(b) (disclosure of health and safety studies),
and §21 (citizens' petitions) are evidence that Congress
intended the public to play a role in assisting EPA in its
review of new chemical substances, and in exercising
oversight of Agency determinations. EPA cannot ignore this
intent by committing itself to a course of action prior to
the opportunity for public input.
2. Acknowledgement of Receipt of Notice
EPA intends to acknowledge its receipt of
premanufacturing notices. This acknowledgement will be more
complex than the simple procedure used for the inventory in
which a self-addressed card, attached to the single-page
form and bearing its unique code number, was detached and
mailed to the submitting party.
First, the premanufacture notice acknowledgement would
bear a date which provides both the submitter of the notice
and EPA with the same date for the calculation of the var-
ious periods for action specified in §5(c), §5(e) and §5(f)
of the Act.
107
-------
Second, the acknowledgement would include a detailed
description of the elements of the premanufacture
notification package which EPA has received. For the
inventory a receipt was issued for each unique, single-page-
form. The premanufacture notice forms will be several pages
long, and the notice package will contain a variety of
attachments, most of which will be for the reporting of test
data concerning the new substance.
The date of acknowledgement of receipt of the premanu-
facture notice will be the date the notice is received by
the Premanufacturing Review Division. Because there may be
a short lag between the receipt of a notice at the EPA
mailroom and its receipt by the Premanufacturing Review
Division, the official date on the acknowledgement may not
match the date on a return receipt if the premanufacture
notice is transmitted to EPA by certified mail. Starting
premanufacture review on the date of receipt by the
Premanufacturing Review Division is justified because the
possibly confidential submittals should not be opened in the
mailroom. Further, the mailroom personnel do not have the
resources to acknowledge receipt of the notices, nor can
they be expected to identify the items received. The
manufacturer need not be prejudiced, because he can submit
the notice a few days early.
108
-------
Acknowledgement of receipt does not represent a finding
by EPA that the prernanufacture notice is complete and valid
in accordance with the requirements of the Act and the
proposed rules. EPA's substantive review of the notice will
not begin until after the Agency has acknowledged receipt.
If EPA later determines that the notice is not required or
is deficient in some manner (see §720.34), the Agency will
inform the submitter of this determination.
3. Determination that a Substance is not Subject to the
Notification Requirement
Concurrent with its acknowledgement of receipt and with
publication of the Federal Register notice, EPA will begin
its substantive review of the premanufacture notice. At an
early stage, the Agency will determine whether TSCA and the
proposed regulations require a premanufacture notice to be
submitted for the chemical in question. If a person has any
doubts as to whether he should submit a premanufacture
notice, he should consult with the Agency prior to submittal
of a notice.
A chemical may not be subject to the premanufacture
notice requirement for any of a variety of reasons. It may
be clear from the notice that the substance is not a
"chemical substance" as the Act defines that term. More
commonly, the chemical substance already may be included on
the inventory. Also, the chemical may be excluded from
reporting requirements for any of the reasons stated in
proposed §720.13.
109
-------
EPA will not automatically seek to determine, upon
submittal of the premanufacture notice, whether an alleged
new substance is included by generic name in an appendix to
the inventory. Persons who desire such a determination
should submit a request under proposed §720.12(b). However,
a person may submit a request for a determination under
§720.12(b) in conjunction with a premanufacture notice,
provided he complies with the special requirements of that
section.
EPA will not inform the submitter whether a
premanufacture notice has been submitted by another person
for an equivalent substance. A substance is not included on
the inventory until manufacture commences; if a
premanufacture notice has been submitted and the chemical
has not yet been added to the inventory, it is still a new
chemical substance. If another person intends to
manufacture such a chemical he must submit a notice himself.
4. Section 5(d)(2) Federal Register Notice
Section 720.32(a) of the proposed rules states that EPA
will send a notice to the Office of the Federal Register
within five days after the Agency receives a premanufacture
notice. Although §5(d)(2) of the Act literally reads that
EPA must publish the notice within five days, in many cases
publication would be impossible. Further, the legislative
history contains explicit support for EPA's interpretation.
110
-------
The Act states that the Federal Register notice shall
identify the new substance by "generic class" unless a more
specific identification is required in the public interest.
Prior to this proposal, industry representatives have
commented that "generic class" is broader than, and should
be distinguished from, the "generic names" which EPA
required for purposes of the inventory and would require
under these rules if a person asserts a claim of confiden-
tiality with respect to the specific chemical identity.
However, there is no statutory basis for such a distinction.
The words "generic name" do not appear in §8(b) of the Act.
Rather, the Agency developed them in its implementation of
the $8(b) requirement to assemble and publish an inventory.
For the purposes of the proposed rules, the term "generic
class" is equivalent to "generic name."
If a person does not claim identity to be confidential,
EPA will publish the specific identity in the §5(d)(2)
Federal Register notice. Identity may be the most important
single piece of information for judging the possible health
and environmental effects of a substance. Therefore the
Agency has determined that unless a claim of confidentiality
is asserted for a specific chemical identity, it is in the
public interest for the §5(d}(2) notice to contain the
specific chemical identity.
Ill
-------
The Act also requires the Federal Register notice to
list the "uses or intended uses" of the new substance. As
set forth in §720.42, EPA recognizes that the use
information submitted with premanufacture notices may be
claimed confidential. EPA's treatment of claims of
confidentiality for use information is addressed in detail
in §720.42, and in section III-A of this Support Document.
EPA may obtain this use or exposure information from a
variety of sources. The person responsible for submitting
the premanufacture notice will provide some such data. In
addition, processors and users (and, in the case of
importers, foreign suppliers) may separately submit such
data. In the Federal Register notice, EPA would list all
uses and exposures of which it is aware, but would not indi-
cate the number of persons who submitted the data or the
uses and exposures associated with specific persons. Sec-
tion 5(d)(2) also requires that, at a minimum, EPA publish
in the Federal Register a description of tests performed and
data developed under §4(a)or §5(b) of the Act. The Agency's
treatment of this requirement is addressed in the Preamble
to the rules and in part I-B of this Support Document.
112
-------
In order to comply with the deadline established by
§720.32(a) and to reduce EPA's administrative burden in
preparing the Federal Register notices, EPA has designated
particular sections of the premanufacture notice form which
would comprise the notice. The submitter would be required
to complete these sections so that no information contained
in them is claimed as confidential. The short time period
between receipt of a premanufacture notice and publication
of the §5(d)(2) notice, and the Agency's decision to reduce
its burden by utilizing elements of the notice form as the
Federal Register notice, make the public dependent initially
for information on the person giving notice. However, the
manufacturer may be hesitant to publicize information
concerning his new chemical substance, particularly any
adverse health and environmental effects. If this leads to
reduced or minimal reporting by industry, EPA may, at a
later date, revise its approach to allowing the submitters
to determine the contents of the Federal Register notices.
In the meantime, if EPA determines that certain notices are
inadequate due to omissions or inaccuracies in any material
respect, the Agency may publish amended Federal Register
notices. These might be necessitated by the need for
significantly narrower generic names or by determinations
that certain identities are not entitled to confidential
113
-------
treatment. Similarly, amended notices may be appropriate if
EPA determines that use and exposure information or test
data have not been reported properly.
If EPA determines that information claimed confidential
is not entitled to this status, and that an amended notice
should be published, the Agency will deny the con-
fidentiality claim and notify the submitter of this fact in
accordance with the proposed regulations (§720.41(a)(4)(iv))
and the Agency's general confidentiality rules codified in
40 CFR Part 2.
114
-------
4. Deficient Notices
Under §5 of the Act and Subpart C of the proposed re-
gulations, each manufacturer would be required to submit
certain information as part of his premanufacture notifica-
tion. If a submitter does not comply with these rules, EPA
may consider his notice to be deficient. Section 5 does not
state what actions EPA should take, or whether the notifica-
tion period commences, if a manufacturer submits a deficient
notice. Similarly, the legislative history of TSCA offers
no clear guidance.
EPA's proposed approach for handling deficient notices
is contained in §720.34 of the regulations and is discussed
in the Preamble. The Agency proposes that its response to a
deficient notice would depend on the nature of the de-
ficiency. EPA would distinguish between relatively minor or
technical deficiencies for which the Agency could request
corrections (§720.34(a)) and more serious deficiences which
are substantive in nature and which will invalidate notices
if discovered during the notification period (§720.34(b)).
EPA specifically solicits comments on its examples of each
kind of deficiency.
In addition, under §720.34(c) EPA would be able to de-
clare a notice invalid after the notice period expires if
the Agency discovers that the notice contains intentionally
false or misleading information. If the manufacturer has
115
-------
started production, EPA would consider him in violation of
the law and subject to penalties under TSCA. However, the
Agency would not initiate enforcement actions against other
persons who may be manufacturing, processing, or using the
substance if they were not involved in submittal of the
invalid notice.
EPA has considered the following alternative approaches
for handling deficient notices.
Option 1; Take enforcement actions when submitters fail
to submit required information, on the grounds that the
notices themselves are not valid.
Under §15(1) of the Act, it is unlawful to fail to
comply with a requirement prescribed under §5. Under §16,
EPA may impose civil penalties for violations (subject to
judicial review) and may seek criminal penalties through
court actions. Under §17 the Agency may seek court orders
for specific enforcement and seizures, where appropriate.
The main advantage to using enforcement actions is
that they may deter other persons from noncompliance with
the premanufacture requirements. However, exclusive
reliance upon enforcement actions to obtain requisite
information has several disadvantages. Initiating actions
under §16 and §17 would be resource-intensive for EPA.
Further, even if the Agency takes enforcement actions the
information might be submitted too late in the notification
period for EPA to initiate actions under the §5 authorities.
116
-------
Therefore although EPA intends to take selective enforcement
actions, at present the Agency does not intend to rely
exclusively on these authorities to respond to deficient
notices.
Option 2; Regulate substances under §5(e) of the Act.
Under §5(e) in certain circumstances EPA may regulate a
substance pending submittal of sufficient information to
evaluate its health and environmental effects. Therefore
§5(e) actions are a possible response to certain kinds of
deficient notices.
However, EPA may need some of the information requested
in the notice forms to make the findings necessary for the
issuance of §5(e) orders. Further, as in Option 1, because
of resource considerations EPA may be able to take only a
limited number of these actions.
More fundamentally, the Agency believes that
manufacturers should submit the information in the notice
forms at the time they submit notices, and not later.
Congress intended EPA to use the §5(e) authority when a
person has complied with the notification requirements and
the Agency needs additional information to assess the health
and environmental effects of a chemical substance.
Option 3; Require Information Through Separate §8(a)
Rules.
EPA may issue reporting requirements under §8(a) for all
of the information required by the premanufacture notice
117
-------
forms, plus certain additional information. Proposed
§720.50 would authorize EPA to issue §8(a) orders to obtain
information to supplement that required in the forms.
However, if the Agency separately required submitters to
report the information previously requested in the forms,
this would be redundant and presumably the manufacturers
again would fail to provide it.
Option 4; Modify the Present Approach
EPA considered certain modifications of the proposed
approach. First, the Agency considered suspending the
notification period if there is any deficiency.
Alternatively, EPA would invalidate any deficient notice so
that the notification period would not begin until a
complete notice is submitted. At this time, the Agency
believes that uniform treatment of all deficiencies may not
be appropriate, because the deficiencies may vary in their
causes and in seriousness. Thus EPA proposes that its
responses to deficient notices will depend upon the nature
of the deficiencies.
Second, EPA considered further limiting the time during
which it could determine that a notice is invalid.
Under §720.34(a) of the proposed regulations EPA must
make a request for corrections of minor or technical
deficiencies during the first 30 days of the review period;
but §720.34(b) would allow the Agency to determine that a
118
-------
notice is invalid at any time during the review period. EPA
is proposing this approach for several reasons. First, the
notification requirements are clearly described and a
submitter should seek clarification if he has any major
questions. Also, upon initial review EPA may not detect
deficiencies which would invalidate the notice, but they may
become apparent with more detailed evaluation. Thus
although EPA intends to identify any deficiencies and notify
the submitter as quickly as possible, the Agency will not
limit itself to doing so during only part of the review
period. EPA specifically solicits comments on this policy.
119
-------
6. Extension of the Notification Period
Section 720.35 of the proposed rules contains several
provisions concerning the length of EPA's period for
reviewing new substances and for providing information on
the status of the new substance to the submitter and to the
general public. Paragraphs (a) and (b)(l)-(3) of §720.35
follow the provisions of the Act and are self-explanatory.
However, in 8720.35 (b) (4) EPA clarifies the provisions of
85 (c) of the Act by illustrating some of the situations in
which EPA believes there would be "good cause" for extension.
Paragraph (b) (4) (i) provides that EPA has "good cause"
for extending the notification period when the Agency, during
the initial 90-day period, determines that a substance
should be regulated but is unable to complete the action
within these 90 days. Another common situation is addressed
by 8720.35 (b) (4) (ii) -- EPA may be concerned about possible
risks associated with a new substance and seek additional
information including use of supplementary reporting under
8720.50 or 8720.51. In this case the Agency may not be
able to obtain or fully evaluate the new information in a
timely fashion and thus need to extend the review period.
Under 8720.35(b)(iv), EPA may extend the notification
period if the Agency denies a claim of confidentiality and
publishes an amended 85 (d)(2) Federal Register notice.
Congress intended that there be a degree of public oversight
120
-------
over EPA decisions in reviewing new substances — if the
Agency publishes an amended Federal Register notice which
contains significant new information, but does so late in
the notification period, the public may be deprived of an
opportunity to review the new substance prior to the
expiration of the notice period.
As the Preamble states, §720.35(c) would provide for a
Notice of Continuing Review. EPA proposes to notify the
submitter of a premanufacture notice whenever the Agency
intends to continue its active evaluation of a substance
after the notice period expires. The rule does not define
phrases such as "has identified" a substance for possible
regulatory action" or "actively considering" regulation.
However, for purposes of its own internal administration,
EPA expects to distinguish throughout the notice period
between those substances to which review resources should be
devoted, and those for which EPA does not intend further
review. With respect to the "Notice of Continuing Review"
the Agency will attempt to reduce the manufacturer's
uncertainty about EPA's likely actions, and economic burdens
caused by that uncertainty. Thus EPA will provide this
notice whenever the Agency continues to devote resources to
further review of a substance and believes there to be a
significant possiblity that the Agency may propose a §6 or
a §4 rule shortly. However, EPA will not issue a notice
121
-------
if the only actions contemplated are the use of §8 re-
porting authorities or designation of certain new uses
of the substance as "significant" under §5(d)(2). These
latter actions are likely to be more common and to be
less burdensome to the affected manufacturers.
The issuance of a Notice of Continuing Review would
not extend the premanufacture notification period. Thus the
submitter may commence manufacture or importation of the
substance at any time after the expiration of the notification
period whether EPA has issued this Notice. Further, the
particular authorities provided in 85 for the regulation of
new chemical substances cease to be effective once the period
ends. However, the Agency can use the authorities of 84,
86(a), 87, and 88(a), as appropriate.
Before proposing to issue Notices of Continuing Review
in appropriate circumstances, EPA evaluated possible
criticisms of this procedure. First, the Agency addressed
whether it should continue to review a new substance after
the notification period expires. The Act establishes
a 90-180 day period for review of new chemicals, and it
could be argued that upon receiving such a Notice, the
intended manufacturer might postpone his plans for com-
mencement of production - i.e. in effect EPA would be
delaying manufacture in a manner not authorized by the
statue.
122
-------
EPA believes these concerns are outweighed by other
factors. Section 6(a) of the Act authorizes EPA to regulate
substances without regard to whether they are existing or
"new." EPA does not waive its right to use S6 simply because
the Agency takes no action under S5, and there is no indi-
cation that a substance is to be "immune" from regulation
for a period after the expiration of the notification period
or the commencement of manufacture. In the legislative
history, Congress expressed a preference for regulation
prior to the commencement of production of the new substance.
If EPA does complete its review and initiate action within
90-180 days, it is still preferable to act soon thereafter
(e.g., in nine months or one year) than to wait even longer.
EPA recognizes that the possibility that the Agency
may still take regulatory action could result in uncertain-
ty on the part of the manufacturer. Faced with doubt about
EPA's future actions, a company could delay any investment in
the new substance or related processes only to find that EPA,
after complete review would decide not to control the sub-
stance. However, given the fact that EPA can act after
expiration of the notification period, it would be far less
disruptive for EPA to identify a small number of prime
regulatory targets than for manufacturers of all substances
for which the review period has expired to believe that
regulatory actions may be imminent. Although the fact that
EPA has not issued a Notice of Continuing Review does not
123
-------
prevent the Agency from regulating the substance at any
time to prevent an unreasonable risk, it is highly im-
probable that EPA would act soon after expiration of the
notification period to regulate any substance not so
designated.
A second, separate concern with respect to the Notice
of Continuing Review is that EPA should impose a time limit
upon this review, to avoid leaving the manufacturer in limbo
for an extended period of time. For its own management
purposes, EPA must avoid open-ended reviews and must establish
internal timetables for making regulatory decisions on new
substances. However, at this time EPA is not able to predict
how long this continuing review might take and, in any case,
there will be great variations in the review of different
substances.
In addition to a Notice of Continuing Review, EPA has
considered whether it should establish a Notice of Intent
Not to Act. EPA could issue such a notice during the notice
review process whenever the Agency becomes convinced on the
basis of the premanufacture notice and other available
information that it will not attempt to regulate the substance
under 85. The notice would indicate that this determination
could be reversed if, for example, EPA later receives infor-
mation that indicates that the substance presented a greater
risk than initially indicated. EPA also has evaluated the
possiblity that it could allow manufacture or import of the
new substance to commence after issuance of such a notice,
whether the 90-day notification period has expired.
124
-------
At an early point in its consideration of the Notice of
Intent Not to Act, EPA rejected the idea that issuance of
such a notice would permit manufacturers to begin production
before the close of the 90-day review period. Section 5(a)
of the Act prescribes this review period. Although §5(h)
authorizes EPA to exempt persons from the requirements of
§5(a), there are restrictions on this authority. The only
provision that appears to apply to this situation is §5(h)(4),
which provides that EPA may exempt a new substance from the
requirements of §5 if the Agency determines that the sub-
stance will not present an unreasonable risk. However,
85(h)(4) requires persons to apply for the exemption, and
EPA may grant it only by rule issued in accordance with the
rulemaking procedures of S6(c)(2)&(3) of the Act (including
public hearings) .
EPA also considered giving the Notice of Intent Not to
Act without any exemption from or waiver of the B5 require-
ments. The Agency recognizes that issuance of a "Notice of
Intent Not to Act" could reduce the period of uncertainty
for manufacturers and importers. Further such a Notice
need not restrict the Agency in its ability to regulate
substances which present unreasonable risks. If EPA
initially decides not to act and issues a notice stating
that decision, the Agency nonetheless could regulate
the substance of it subsequently receives new information
125
-------
that is grounds for a reversal of this decision.
On the other hand, Congress intended the public to
have, at a minimum, a 90-day comment period to review the
existence and acceptability of risks from new substances.
If EPA makes a decision not to act with respect to a substance
prior to the full opportunity for public input, this may run
contrary to that intention. Also, use of such a notice could
be misconstrued as affirmative approval by EPA of the safety
of particular substances, and could be interpreted by the
industry as a waiver of EPA's right to regulate the substances
in the future. Finally, the issuance of large numbers of
such notices could impose an administrative burden on the
Agency, drawing resources away from more important tasks
associated with the review of new substances.
126
-------
7. Supplementary Reporting Provisions
Some premanufacture notices will not contain sufficient
information for EPA to evaluate the subject chemical
substances and, if appropriate, to take actions under §5(e)
or §5(f) or to prescribe "followup" reporting requirements.
Premanufacture notification information may be inadequate in
several respects. First, the notification may not include
basic information specified in the notice form itself. For
example, this could happen if client processors and users do
not voluntarily provide use and exposure information to the
submitter or to EPA or if manufacturers of chemicals used in
the synthesis of the new substance do not identify them to
the submitter. Second, for some substances of particular
concern, the Agency may need information which supplements
or provides further detail on that provided in the notice.
Third, submitters may identify health and safety studies
which are inaccessible to them and which would help EPA to
evaluate effects associated with their new substances.
In Subpart F of the rules, EPA proposes requirements
under TSCA §8 and §5 to address these potentially serious
information gaps. (Section 8(a) and §8(d) provide that EPA
shall promulgate rules "under which" the Agency can require
information submittals. EPA considers this statutory
language to authorize the issuance of general rules which
prescribe the circumstances and scope of information which
the Agency subsequently may require using administrative
127
-------
orders.) Under proposed §720.50 and §720.51, EPA may
require defined classes of persons to report specific types
of information on a case-by-case basis. Under §720.50 EPA
could require reporting of the types of information
encompassed by §8(a), including not only the illustrative
types listed in §8(a)(2), but additional kinds of
information as necessary to serve the purposes of the Act.
Under §720.51 the Agency could require the submittal of
identified health and safety studies in accordance with
§8(d).
EPA considers this reporting approach to be the most
practical and expedient way to acquire necessary information
while addressing the following concerns:
1. EPA probably will need to obtain supplementary
information during the notification period to
support many of its §5(e) and §5(f) actions.
2. The proposed notice form should require information
basic to a review of all new chemical substances.
Although some substances may require more detailed
scrutiny, the forms do not anticipate the types
of information EPA might require in every case - to
do so would be extremely difficult and would
generate unneeded information on many new
substances. However, EPA must ensure that it is
able to acquire supplementary data on those
substances which require in-depth review and
evaluation. The proposed supplementary reporting
128
-------
requirements would provide this assurance, and
would preclude the need for more extensive and
burdensome initial notification requirements.
3. Some submitters may not have access to certain
information necessary for effective premanufacture
review. For example, because of confidentiality
concerns some processors and users may not reveal
the precise nature of their commercial activities
to their suppliers who also are the manufacturers.
Manufacturers themselves may conceal the precise
identity or contents of chemical substances and
mixtures which they sell to others. Finally,
submitters may be aware of the existence of certain
health and safety studies, but not have access to
them.
The proposed supplementary reporting provisions would
provide EPA access to this information. However, the Agency
intends to use proposed §720.50(b) and (d) only when
absolutely necessary. Under the proposed regulations
manufacturers are responsible for ensuring the completeness
of their submittals. Also, EPA has prescribed procedures
for identifying and obtaining information which is known to
or reasonably ascertainable by submitters. (See proposed
S720.20(e).)
129
-------
Persons may be concerned that EPA could, through these
specific reporting requests, impose excessive and burdensome
requirements. The Agency cannot avoid some uncertainty as
to the precise nature of the information to be required in
particular cases. However, EPA has mitigated this concern
in three ways. First, the Agency has carefully specified
and limited the circumstances under which it would issue
reporting orders and the information to be reported.
Second, to ensure the responsible exercise of this
authority, only the Assistant Administrator for Toxic
Substances or his designee would be delegated the right to
impose such reporting requirements. Third, at this time the
Agency is providing a general opportunity for public comment
on the suitability of this approach.
Section 720.50 and §720.51 would apply only to chemical
substances for which premanufacture notices have been sub-
mitted. EPA presently is considering other situations in
which similar authority to require reporting under §8(a) or
§8(d) may be necessary. If the Agency develops a general
rule to address these situations, it will supersede §720.50
and §720.51.
EPA specifically solicits comments on the use of
&720.50, pending development of general reporting rules, in
those cases where the Agency continues its initial review of
chemical substances after the expiration of the relevant
130
-------
notification periods. EPA must be able to supplement its
information base after the notification period expires. The
proposed use of administrative orders has the practical
advantage of directing requirements to identified persons
rather than promulgating rules of general applicability.
The proposed rules would authorize the imposition of
reporting requirements to the same classes of persons and
under the same limited circumstances both during and after
the notification period.
The Proposed Rules
Proposed §720.50 would authorize EPA to require
supplementary information from the manufacturer of a new
chemical substance, the manufacturer of an unknown reactant
used to synthesize the new substance, and a person who
intends to process the new chemical substance. This rule
would significantly restrict the types of, and purposes for,
information which may be required of each class of persons.
Under proposed §720.50(b), EPA could require a person
who produces a reactant used in the synthesis of the new
substance to report the identity of the reactant to EPA.
This provision is a backup mechanism which the Agency does
not expect to use very often. However, it is important
because under proposed §720.20(f) and 720.34(b)(1)(x), a
notice would not be valid if it does not contain the
specific chemical identity. EPA intends the submitter of a
premanufacture notice to have primary responsibility for
ascertaining the chemical composition of his substance, and
131
-------
to request the producers of any unknown reactants to
identify them to the submitter or directly to EPA. The
Agency would use its authority under this paragraph only
after the submitter has demonstrated a reasonable effort to
obtain the information voluntarily. This policy continues
the approach which EPA used in generating the inventory of
existing substances under §8(b) of the Act.
EPA has a strong need for information on specific
chemical identity. In some cases, without identity of re-
actants the Agency will be unable to determine the com-
position of new substances. Lacking this data, it will be
diffcult for EPA to evaluate the effects which a substance
may present, to determine whether further tests should be
performed, to establish whether the substance already is on
the inventory, or to add it to the inventory after the close
of the review period.
Under proposed §720.50(c) and (d), EPA may require the
submitter and any persons who expect to process the new sub-
stance to report exposure and use information that the Ag-
ency needs to determine the likely levels of risk associated
with the chemical. EPA also could require information on
benefits, substitutes, and economic factors that will help
the Agency determine whether given risks are "unreasonable."
132
-------
Under proposed §720.50(d), processors generally would be
required to provide the basic information which the notice
form requests from manufacturers. Processors would be re-
sponsible only for information concerning their own proces-
sing of the new substances and for information already known
to them concerning their customers' processing, distribution
in commerce, use, disposal, and other handling of the sub-
stances. In many cases, processors may avoid such reporting
requirements by cooperating with submitters who attempt to
acquire information under the procedures of proposed
§720.20(e). EPA would most likely use this authority if
available data suggest that a new substance may presesnt a
significant risk to health or the environment. The
additional reporting would provide information that the
Agency would use to evaluate exposures associated with the
substance. Finally, it is likely that EPA would require
non-risk information (e.g., information concerning benefits,
substitutes, and economic impacts of regulation) only if
test and exposure information indicate the possibilities of
significant levels of risk.
If EPA identifies a need for supplementary information,
the Agency first may contact the person informally and re-
quest voluntary reporting. Paragraph §720.50(e) prescribes
133
-------
the formal procedures that EPA will use to require
information submittals. These procedures minimize the
reporting burden by providing that the Agency will describe
information in as great detail as is necessary to enable the
person to comply expeditiously. (Tight, but in no cases un-
reasonable, deadlines may be necessitated by the statutory
premanufacture review time limits.) In addition, EPA will
designate an Agency contact from whom the manufacturer or
processor may seek clarifications and information concerning
his reporting obligations and to whom he may provide ex-
planation concerning any difficulties which he may have in
responding.
Under proposed §720.51, EPA may use the same procedures
as in §720.50 to require a person to submit to the Agency a
health and safety study in his possession concerning a new
chemical substance. Section 8(d) of the Act is the
authority for this rule and applies only to the submittal of
health and safety studies. Section 8(d) authorizes EPA to
require any person in possession of a health and safety
study to submit it to the Agency, and does not contain any
small business limitations. Using the authority of proposed
§720.51 EPA could issue a reporting order if the Agency
learns through a premanufacture notice (most commonly under
134
-------
§720.23(b)) that a health and safety study exists for a
substance but is not in the possession or control of the
submitter. EPA would need such a study to determine whether
it should regulate the substance under §5(e), $5(f) or
§6(a)f as well as to determine whether some aspect of the
substance's inherent toxicity justifies followup reporting.
Alternat ives
EPA has considered the following alternatives to this
proposed approach.
Option 1: Attempt to obtain needed information on a
voluntary basis.
When EPA needs additional information concerning a new
chemical substance, the Agency could ask the appropriate
person to supply the information voluntarily. In many cases
the person might comply, to ensure an expedited review of
his notice. However, to rely on voluntary compliance ex-
clusively does not guarantee EPA will be able to obtain all
relevant information. Voluntary compliance is not a sepa-
rate option. Rather, it is a means to be employed to the
extent feasible and to be supplemented by reporting re-
quirements where necessary to evaluate substances for pos-
sible regulation prior to manufacture.
135
-------
Option 2; Promulgate a separate §8 rule each time EPA
needs additional information
Under the authority of §8(a) and §8(d), EPA could
propose and promulgate separate reporting rules each time
the Agency needs additional information. EPA would issue
such rules in accordance with the Administrative Procedure
Act (APA) and EPA's own internal rulemaking procedures.
These procedures would include internal Agency review,
proposal for public comment, receipt and review of such com-
ment, and final promulgation.
In general, a §8 rulemaking can take either of two
forms. These are distinguished by the predictability of the
particular information needs, the degree to which EPA is
able to design the rule in advance to meet those needs, and
the time required for the rulemaking.
First, at the time EPA identifies a need for information
and specifies that information, the Agency could develop a
rule to satisfy that particular need in accordance with the
APA and EPA's own internal rulemaking procedures. Such
rulemaking would require from nine months to one and
one-half years from the time the need is identified to final
promulgation.
Second, EPA presently is developing "model" §8(a) rules
for which the circumstances of use and the scope of
reporting requirements generally would not vary among
136
-------
specific chemicals. (These will be similar to the model
§8(d) rules which EPA has developed to support its §4(a)
findings. (See 43 FR 30986, July 18, 1978.) In applying
such rules to particular chemicals, APA and EPA procedures
would be greatly expedited because comment would not focus
on the details of the model rules themselves, but on their
suitability for the particular circumstances. In spite of
this, four to six months generally can be expected to elapse
before the receipt of data. Furthermore, for §5 purposes it
will be difficult to specify information needs (with the
exception of health and safety studies) to the extent
necessary for this approach.
The major disadvantage to promulgating a separate §8
rule whenever EPA needs information to supplement a premanu-
facture notice is the time required for promulgation of the
rule. Even the fastest rulemaking would require from four
to six months. Although this time period may not
automatically foreclose the premanufacture period, it could
severely reduce the Agency's ability to give careful
consideration to the information and often could foreclose
some significant regulatory options for EPA. (E.g., If EPA
issues an administrative order under §5(e) or §5(f), it must
do so within 135 days of receipt of the relevant notice.)
137
-------
Option 3; Conduct inspections and issue subpoenas
under TSCA §11
Sections ll(a) and (b) of the act authorize EPA, under
certain restrictions, to inspect premises or conveyances in
which chemical substances or mixtures are manufactured,
processed, stored, held, or transported. Section ll(c)
authorizes the Agency to issue subpoenas which require the
attendance of witnesses and the production of documents and
other information needed by the Agency. EPA has considered
the possibility of employing these authorities to require
information necessary to supplement that submitted with
premanufacture notices. Several factors argue against
exclusive reliance on this approach for supplemental
information gathering.
First, much of the needed information will be that
specifically mentioned in the illustrative §8(a)(2) listing,
and most of the remainder will be within the scope of §8(a)
and §8(d). Thus the most straightforward and effective way
to acquire the information is under the authority of §8.
Second, EPA considers §8 to be the Agency's major reporting
authority, and more appropriate than §11 to meet repeated
information needs. Under §11, EPA may conduct inspections
to acquire information "bearing on whether the requirements
of this Act applicable to the chemical substances or
138
-------
mixtures within such premises or conveyances have been
complied with." Furthe'r, the fact that the authority to
issue subpoenas resides with EPA (and does not require
rulemaking) suggests a usage restricted to ad hoc
circumstances rather than repeated reporting needs.
Finally, conducting inspections of premises and conveyances
is not the most expedient way to acquire information to
supplement notices, and would in many cases impose an
unnecessary burden and effort on all persons involved. Of
course, EPA will use §11 as necessary to ensure its
acquisition of necessary information during the notification
period.
Option 4; Issue a more extensive premanufacture notice
form
A final option available to EPA is to preclude the need
for supplemental reporting by specifying more extensive
initial notification requirements. For the reasons
discussed above, the Agency has discounted this option in
favor of a more restricted initial notification in conjunc-
tion with supplemental reporting provisions.
139
-------
8. Supplementary Reporting —- Small Business Definition
As discussed in the preceeding section of this document,
subpart F of the regulations proposes supplemental reporting
requirements to be used in conjunction with the premanufacture
notification procedures. To the extent that these require-
ments are based on the authority of §8(a) of the Act, EPA
may not impose them on small manufacturers and processors.
The regulations in §720.50(a)(2) propose to define a "small"
manufacturer or processor as a person whose total annual sales
are less than $1,000,000. This definition only is applicable
to these rules; it is not a general small business definition
to be used for all §8(a) reporting requirements.
Congress included the exemption of small manufacturers
and processors from some reporting requirements to avoid
unreasonably burdening small businesses with reporting and
recordkeeping requirements. Congress did not define the term
"small manufacturer or processor," but left it to EPA to
develop a definition. In evaluating the reasonableness of
a reporting requirement, the Agency considers the burden placed
upon a small business by the reporting requirement and EPA's
legitimate need for the information to carry out its legis-
lative mandate under TSCA.
140
-------
EPA considered several alternative parameters for the
small business definition in these regulations, including
corporate assets, employment, sales per chemical, production
volume, and annual sales. In choosing a parameter, EPA
evaluated each in terms of ease of data identification
and collection for the firm; ease of access by the Agency; and
whether the parameter would reflect not only the comparative
size of the firm, but also the firm's ability to bear the
burden imposed by the reporting requirement. Although each
of these parameters has certain favorable characteristics, EPA
believes that none exhibits a better combination of simplicity
and availability to the company than annual sales. Annual
sales are easily determined by manufacturers, and usually are
reported publicly at regular intervals, making administration
simpler for industry and EPA alike. Further, annual sales are
useful in determining the reasonableness of reporting burdens,
because they provide an indication of a company's ability to
divert cash flow to reporting costs. However, a drawback to
the annual sales parameter is the fact that it does not relate
the reporting cost to the profitability of the chemical in
question, but only to the sales of the firm.
Options
The Agency has considered several options for defining
"small business" for purposes of the supplemental reporting
requirements. One option would be to use a single annual sales
141
-------
figure, or a definition which incorporates annual sales and
the projected volume of the particular chemical. The former
approach has the advantage of simplicity of administration for
both industry and EPA. A single annual sales figure would
leave no doubt on the part of a firm as to whether it fits the
definition of a "small" business. Likewise, EPA could determine
whether the company is "small" with a minimum of effort. Thus
such a definition would result in smooth operation of the supple-
mental reporting procedure.
A second option would be to combine annual sales and the
projected sales volume of the new substance. This would have
the added advantage of associating the burden of the supplemental
reporting requirements with the substance in question. By
lessening the probability that supplemental reporting would
be required for substances with small volumes, this option
would mitigate the impact of these reporting requirements upon
innovation in the area of low volume chemicals. However, such
a definition could provide an incentive for businesses to under-
estimate the projected sales volumes of new substances and
thereby avoid these supplemental requirements.
The third option would be to employ a multiple definition,
which would classify the various types of information which
might be requested according to the cost or difficulty involved
142
-------
in obtaining the information. Such a multiple definition
could assign a unique annual sales definition to each type
of data or task which the Agency may require. Larger defi-
nitions of small business would be assigned to those pieces
of data tasks which would be relatively more burdensome to
complete. For example, chemical indentity should be easier
to determine than employee exposure data. Under this option,
smaller companies could be asked chemical indentity information,
but only relatively large companies could be required to pro-
vide exposure information. Although this option would sacri-
fice much of the simplicity of a single-number definition, it
would link EPA's authority to require information more directly
to the firm's ability to supply the information. By tying the
small business definition directly to the cost of supplying the
information, this option would exclude some small firms from
the requirement to submit certain more costly information,
and assure that the burden of the supplemental reporting re-
quirements would be proportional to the size of the firm.
The fourth option is a "dual" definition, which would
establish a lower annual sales boundary below which a firm never
would be subject to the supplemental reporting requirements,
and an upper sales boundary above which a firm always would
be required to report. Firms falling between the two boundaries
would be subject to the supplemental reporting requirements only
if EPA determined on a case-by-case basis both that it needed
143
-------
the information to evaluate the chemical, and that the
burden placed upon the reporting firm would not be unreason-
able. Thus, for any firm between the two boundaries this
option explicitly would require the Agency to balance its
need for the information against the costs of developing and
reporting the information. This option would provide more
flexibility than the other options. However, such a defini-
tion would leave many firms in the "gray area" between the
two boundaries uncertain as to whether they would be required
to report. This uncertainty could lead to confusion on the
part of both industry and EPA, and thus could slow the supple-
mental reporting procedure.
EPA has estimated the costs of reporting under proposed
§720.50. The Agency estimates the average reporting cost for
each new substance under the supplemental reporting requirements
to be $2,500, with the potential reporting costs ranging
betweeen $160 and $5,680. This calculation assumes a cost of
$30/hour for managerial personnel, $20/hour for technical
personnel, and $10/hour for secretarial time. In these costs,
it is assumed that the company will contact the ten largest
proposed users of the new substance to identify any information
which is not available in-house. These cost estimates appear
in Table I. Using the historical long-term profitability of
the U.S. chemical industry of 6% of the value of sales, the
upper portion of Table II shows the possible impact of these
reporting costs on the profits of a firm with sales equivalent
144
-------
to the possible definition figures (firms on the margin).
EPA also has estimated the impact of the supplemental
reporting procedure at five different annual sales figures
which could be used as single number definitions for "small"
business. Each level of sales was rated according to the
number of manufacturing firms, percentage of sales, percen-
tage of employment, and percentage of establishments covered.
These estimates appear in the lower portion of Table II.
Proposed Definition
EPA has selected a single annual sales definition of
$1,000,000 as its proposed small business definition for
these supplemental reporting requirements. As shown in
Table II, a definition of $1,000,000 in annual sales would
involve 3,016 firms which account for 99.2% of manufacturers'
sales and 98.6% of manufacturers' employment. A definition
of less than $1,000,000 would not give the Agency substantial
additional information from manufacturers. Although a
sizeable number of firms have sales below $1,000,000, they
represent only a small percentage of total industry sales and
employment. This also assumes that firms with sales below
$1,000,000 account for a relatively small percentage of the
innovations in the chemical industry, and therefore of pre-
manufacturing notices which might trigger requests for infor-
mation under this authority.
145
-------
Further, because the costs imposed by supplemental
reporting requirements will not vary significantly with the
size of the firm, a definition of lower than $1,000,000 would
impose a relatively high burden on smaller firms. For
example, if the cost of compliance with these supplemental
reporting requirements is $2,5000, and if the profit rate
for a firm is six percent, these requirements would cost
an amount equal to 4.2 percent of the profits of a firm with
$1,000,000 in sales, and 41.6 percent of the profits of a
firm with $100,000 in sales.
A definition greater than $1,000,000 might unduly
hamper EPA's ability to gather information necessary for
implementing the premanufacture notification program. A
major purpose of the supplemental reporting authority is
to allow EPA to require information from processors and
users concerning the potential uses of chemical substances
for which premanufacturing notices are received, to determine
whether to take regulatory action. A relatively small
definition is needed for these requirements, because pro-
cessor and user firms tend to be concentrated in lower sales
categories than are manufacturers.
146
-------
-p
CO
0> Q
cnO
m
M -V
II
CO
8
1
S
g
g-t
p~i
<
n
y
g
fv]
&^
1
in
§
KH
^
CO
8
1
i~H ft"!
w
1-5 en
OQ E-i
S CO
E-i O
CJ
0
1
|
6
§
1^
S
M
a
K
M
g,
S
en
CO
"8
|
0)
•M
J
CO
EH
O>
C
-4-J
I
s
CO
3
•5
^
v-* *i>4
11
^3
rH -P
(0 CO
•rt Q
-P O
c
D ^
-P CO
3
a
CO
8
CO
1-1
3
00
•oo-
rH
•
O
•8
-P 0
CO 00
4-J CU ^*
M 3 -00-
«
0
CN
w
^*
CN
c
o
C-H
I i C
u o
•H 4-1
4-1 C
•H M
O
-o £
E m
3 K
CO
CO 4-1
< 0
0)
m *• ^
§ -p -p
C -H O
-U 3
0) C M
13 0) 4->
n3 T3 co
M -H
-p l-l
rH (tj
1-1 (0 rH
O O 3
•H O
C g 0)
1 "8 §
"i"
_u
t[ [ ^^
D^ ••"{
C M
*^* C
-P 01
a ^
0) rH
-P
C
K
u
•H
CO
^ c
•H
-P
u
a
Ql
CM
M rt3
-s 1
£ 0)
1 "
^ -. ^
(0 (3
C 3
C
0) C O
'U 'H 'H
0 -P -P
O C U
«§"§
OT y *
w to a
•H CO 4-4
CP 0) O
T3 3 dp
0
m l-i rH
S
CO
0)
•H
-P
-P
S
S
(1)
w
D
2
•§
-p
•H
1
4-1
O
U
OJ
O
00
•00-
rH
•
O
O
00
^*
V)-
o
CN
•00-
^*
CN
cn
.S ..
-P C
c o
3-H
O -P
rj o
U 3
OJ 'O
0
CO M
t^
3 4-1
"8 °
U dP
QjrH
^1
U M-t
£
1
J>SJ
•°
M— 1
0
c
o
•H
-P CO
p. 4J
•H O
U fO
CO O
(U U
Q PI
E
«
rH
D
E
&
rH
(0
'1
dJ
O
vo
IT)
CN
00
o
0
CM
co
co-
0
CN
•oo-
VO
rH
0)
4-1 V-l
0 0
C "
O CO
•H 0)
-P U
fO 3
U CO
3 Q
TD Qi
T3 0)
0>
U -*
O) 1-1
1 ^
*
S
(0
TS
C 0)
31
"0 -H
-p u c
•r-1 CO Sj
C 0>
CT* 'O rO
rH 13
° -3
cn
c
o
•H
-p
1-1
o
4-1
.5
rH
(0
CO
a
CO
•«-l
Q
2
CO
S
u
to
§
4-t
0
147
-------
-P CO
H
3
§
(0
8
CO
t-l
3
vo
en
vo
o
0
VO
rH
CM
CO
r*
f^J J[^
^
C °
O CO
0
CO -P
-p rg
0 -3
U-l -P
UH CO
0 0
Jl
•g
rH
(0
0
g
CO
Jj
o
0
U-l
nj
pr^
x— *
rH
.*— -
O
VO
Ml
flj
0
1
CO
CO
a
s
3 CO
CO T3
O W
&i rO
0 Oi
vo
v>
o
o
VO
rH
•co-
o
CM
to-
co
I
enviroi
ates of
§!
CO CO
-p 0
$,•0
t|^j rj
^^
6 c
-p
c
o
1-1
•H
f*
0
g
CO
-P
S
U-l
UH
W
E
vo
en
•co-
vo
•
o
0
VO
rH
V>
0
CN
00
^
0
U
3 C
CO CO -H
a*O
U CO
X (0 -P
0 3-H
DiUH
rH 0 0
ro UH C
-P (0 01
c co JS
vironme
ssible
known
c o -P
0 Qj CO
•H
rH
(0
CJ
•H
"6
0
-|J
UH
0
fl
•H
UH
g
OQ
c
VO
en
•co-
vo
t
0
o
rH
Vr
O
CN
•CO-
CO
£
* o
-P CO
"S-H -H
"rH -P CO
-P rO CO ro
CO 0 -Q JJ
O X! 3
U CO C
UH 0 c co
0 0 S 0 4J
CO (3 C ro UH
-P UH _CQ 0
•H
-p
JS
3
CO
UH
O
5
•H
•8
rH CO
•
•
o
o
CN
ro
•CO-
CD
CN
VO
1
JJ
c impor
reasons
•rH
li
O UH
0 -p
•"3 0
tH O
o g
w S3
a
M— I
o
CO
§
0
§
.a
g 0
C 3
H
£
-P
S
CO
•rH
1
4-1
ro
IS
0*3
*.M
>i CO
•g*
o
vo
rH
•CO-
\f)
t
o
o
(N
CO
o
CM
VO
rH
1
'O
0
S-l
8-
U
•H
MH
•H
-P
a
0
-5
5
•H
0
rH
rH
•H
(0
ro
-P
O
"-'
i— j
(0
C
0
-p
i3
•D
(Q
CTi
•H
CO
a
1
3
CO
•iH
CO
a
0
+*
0
^1
c
fo
t,.j
£
i
1-1
Mg
o-*
H ] i)
^ Ij
V_i M 1
CQ-H
S?
.g1!
CO >i
03 i-t
tJ
- CO
0 CO
> 0
o o
"i S
o
CM
in
o
o
00
•co-
cs
CM
•CO-
CM
-p
o
-P CM
8c
H 3
0 tr>
rH C
(0 ro
CO C 0
§ * M
3 g o 0
O ro MH co
CO C
0 co o
to rH -P a
-P -H rH CO
ro CU 3 0
•O B co 1-1
CO
-p
rH
3
CO
0
0
PKJ
1
148
-------
-p
CQ
II
00
00
CN
-------
o
o
0
v
o
o
rH
0
O
o
0
o
in
0
o
o
v
vo
o
0
o
o
co
0
o
in
«.
CN
dp
vo
•
rH
*J-
<*>
o 1 co
0
in
CN
t
00
0
CN
*t
in
CN
a\
co
o
o
o
o
o
o
fc.
o
o
in
*.
CM
o
o
o
o o
O <£>
O
o
o
o
o
in
O O
o o
o o
h. ft.
o o
o o
o n
m
W OP
D vo
o
o
in
fe,
CN
o
o
in
*.
CM
o
o
in
^
CN
a
b
m [a
EH O
M r£
I
O
00
vo
in
o
vo
CN
•
^t
dp
r-
dP
00
CN
CTi
r-
r-
CN
VD
iH
o
^
n
-— dP
«3 •t
in ^r
CN
in •«* <
H ro
oo -^
r-
CTi
CN CN OO
M CN r-
CN ^"
OO
in
CTi
CTi
CTi
CTi
00
in
•
vo
in
s
dP
s s
in ---
00 00
CN •
M in
^00
CFi *-»
in
in
oo
o
00
-
co
**
in
in
V£> CN
«. VO
-^ CN O>
in vo •
in rH
oo >• m
vo in —
CN in
'a* •
CN
••CO
in
a.
§
s
W
01 1-1
M O
Q CO
S en
0) CJ
03 U
H CX
&'
W
(U CQ
'rt S-l
C (1)
fQ Lj
P( ^
§^ i
o
ro
*
•K HC
150
-------
O CM
O •
O CTi
- CM
O
O
CM
CM
CM
O CM
o rn
o
" CM
o CM
o
in
oo
cr>
o
o
o
•>
o
o
o
en
oo
en
ro
o
o
o
^
o
o
in
w
CN
00
CN
O
m
en
o
o
o
^
o
o
o
^
in
in
CTl
en
CN
en
151
-------
9. Actions Under 85(e) and S5(f) of the Act
As discussed in the Preamble, 85(e) authorizes EPA
to regulate a new substance pending development of information
sufficient for evaluating its health and environmental effects.
Proposed §720.36(b) addresses procedures EPA would follow
to initiate a §5(e) action by issuing a proposed order. The
rule states that EPA may issue an order not later than 45 days
prior to the expiration of the applicable notification period.
This notification period, as defined by §720.35, would include
any extensions under the authority of S5(c) of the Act, and
any additional time resulting from a suspension of the notifi-
cation period under proposed §720.34. If EPA extends the
notification period for the maximum 90 days, the Agency could
issue a proposed §5(e) order as late as 135 days after the
official date of receipt of the premanufacture notice.
EPA proposes to send notices of a proposed §5(e) action
not only to the submitter of the premanufacture notice, but
also to other persons who may be affected by the order. An
order under §5(e) may affect many persons in addition to the
one who submits the notice. These would include the manu-
facturer's direct customers, plus others in the chain of
distribution of the substance. Therefore these persons should
have an opportunity to object to the terms of the order.
Even if EPA does not explicitly provide such an opportunity
under §2 (a) of the Act, an affected person could petition
EPA regarding the order.
152
-------
EPA must confront two problems in providing effective
notice to this broad class of affected persons. First, the
Agency may not be able to identify all affected persons. In
addition to the submitter of the notice, EPA proposes to
give written notice to all persons whom the manufacturer has
identified, in accordance with 8720.20(e), as likely to be
handling the new substance, as well as to any others whom the
Agency believes will manufacture the new substance. In
addition, EPA will publish a Federal Register notice which
describes the proposed order. The legislative history of
the Act indicates that the Agency must provide actual notice
in writing of a proposed order, and that the notice should
not be published in the Federal Register. EPA interprets
this to mean that the Federal Register notice should not be
used in lieu of actual notice to the submitter; the Agency
will use the Federal Register notice to supplement the
actual notice process.
The second problem concerns confidentiality. It may be
difficult to inform persons that EPA's proposed order will
apply to them unless the Agency specifically identifies the
chemical substance. Also, it may be difficult to inform others
of the nature of EPA's proposed regulation without revealing
information concerning possible uses of the substance. Some
of this identity and use information may be confidential.
Section 14(a)(4) of the Act authorizes EPA to disclose confi-
dential information "when relevant in any proceeding," but
charges the Agency to preserve confidentiality to the extent
153
-------
practicable without impairing the proceeding. EPA specifically
solicits comments on utilization of §14(a)(4) in the context
of a §5(e) proceeding.
Under proposed §720.36 (b) (3), a manufacturer or processor
of a substance subject to an order could file an objection
to the order. EPA must receive the objection within 30 days
after the person receives written notice of the order or, in the
case of persons who are not specifically identified as likely
processors or manufacturers, within 30 days of publication of
the Federal Register notice. In his objection, the person
would have to specify with particularity those provisions of
the order to which he objects. In practice this would mean
that an objector must address each provision and must state
the grounds for any objection. If objections are not made to
any specific parts of the order, those parts would take effect
upon expiration of the notification period. An objection would
be required to address the findings made by EPA in issuing
the order, including the sufficiency of information about the
substance, the extent to which there is a basis for concern
about the health and environmental effects of the substance,
the volume of production, and the significance of any human
or environmental exposure.
Proposed §720.36(c)(2) creates an administrative
procedure to address a question raised by §5(e)(2)(D) of
the Act. That section states that the District Court which
issued an injunction shall dissolve the injunction once
154
-------
sufficient test data are submitted to EPA and the Agency
evaluates the data, unless EPA has initiated a proceeding
for the issuance of a §6(a) rule. However, the Act does not
indicate the length of time which EPA should be allowed in
which to evaluate the data and determine what, if any, regulatory
action is appropriate. Proposed §720.36(c)(2) states that
any time after an injunction is granted, a person subject to
the injunction may submit to EPA new information which the
person believes is sufficient to permit a reasoned evaluation
of the health and environmental effects of the substance, or
which otherwise justifies modification or dissolution of the
injunction. Within 90 days after it receives such information,
EPA will inform the submitter whether the Agency will petition
the court to modify or dissolve the injunction. In particular,
EPA will indicate whether it believes that the information is
sufficient for a proper evaluation of the effects of the
substance and, if so, whether the Agency intends to propose a
rule under §6(a). EPA bases the 90-day evaluation period on an
analogy to the statutory premanufacture notification period.
As discussed in the Preamble, 85(f) of the Act authorizes
EPA to take a variety of regulatory actions with respect to
a new chemical substance, including prohibiting or limiting
manufacture, processing, distribution in commerce, use, or
disposal. Proposed §720.37 would establish procedures for
actions under 85(f). The procedures pertaining to proposed
orders under 8720.37 are virtually identical to those in
8720.36, with one practical difference. Because a 85(f)
155
-------
action is not based on a finding of insufficient information,
an order proposed under §720.37 (b) (2) would not indicate the
type of additional data EPA would consider necessary to complete
its evaluation of the substance; consequently, there is less
emphasis on the submittal of new test data concerning health
and environmental effects.
Because a proposed S5(f) order would prohibit the
manufacture of the substance, the substance subsequently would
be ineligible for inclusion in the inventory. At a later
date, another person who intends to manufacture the substance
may decide to submit a premanufacture notice. However, because
EPA already would have reviewed the substance and determined
that it presents or will present an unreasonable risk, the
Agency will not consider the submittal to be a valid premanu-
facture notice. Rather EPA will review the submittal in
light of the existing record before the Agency and consider
it to be a petition to amend the preexisting 85(f) order.
Proposed §720.37 (c) would address injunctive actions
under S5(f). As with §720.36(c), the rule states that EPA
may apply for injunctive relief at any point during the pre-
manuf acture review period. However, unlike the provisions
for §5(e) actions, this section contains no special procedures
for EPA review of new data prior to informing a regulated party
whether the Agency will request the court to modify the
injunction. A §5(f) order is based on a finding of unreasonable
risk rather than on a lack of information necessary to assess
risk. Section 5(e)(2)(D) of the Act specifically contemplates
156
-------
dissolution of an injunction upon submittal of additional
test data; 85(f) does not. However, although the rules
would not establish a formal petition procedure, EPA will
encourage affected persons to consult informally with the
Agency if they have in their possession information they
believe would support a modification of a 85 (f) injunction.
Section 720.37 (c) would set forth procedures for limiting
the production and use of a substance under 85 (f). A rule
under 85 (f) is a 86(a) rule which takes effect upon the
expiration of the notification period. EPA must issue it
in accordance with rulemaking procedures under 86(d}(2)(B)
of the Act. Proposed 8720.37(c)(1) would implement
the public notice provisions of S6(d)(2)(B) and S6(c)(l) of
the Act. When a rule is proposed, EPA would publish in the
Federal Register a statement with respect to the factors
listed in 86(c)(1). In addition to a Federal Register notice,
the statute requires EPA to give expeditious notice to
"interested" persons. The proposed rules interpret this to
require written notice within five days after publication in
the Federal Register to persons whom EPA believes intend
to manufacture, process, distribute in commerce, use, or
dispose of the substance.
Paragraph 720.37(c)(2) addresses the procedures to
be followed if a person requests an informal hearing on a
proposed rule. EPA would conduct any such hearing in accordance
157
-------
with 86(d)(2)(B) of the Act; this section in turn incorporates
§6 (c) (2) and (3) .
EPA previously has promulgated procedural rules which
apply to all rulemakings under the authority of §6 of the Act.
(40 CFR Part 750,42 FR 61259, December 2, 1977.) Many of
the time periods established in Part 750 are inconsistent with
the schedule contemplated by §6(d)(2)(B) for immediately
effective rulemaking. For example, §750.2 states that
written comments must be filed two weeks before the hearing
commences. This requirement must be waived for immediately
effective rulemaking because EPA must commence a hearing
within five days from the date the Agency receives a request.
Similarly, 40 CFR 750.4 (b) requires reply comments to be
filed no later than two weeks after the close of the hearing.
However, under S6(d)(2)(B) EPA must promulgate its final rule
within ten days after the conclusion of the hearing. 40 CFR
750.6 also contains several deadlines which are inconsistent
with the schedule for hearings on immediately effective
rules. Within the next few months EPA will explore the
question of how expedited 86 hearings should be conducted
and will propose modifications or additions to Part 750,
as appropriate.
158
-------
III. MAJOR ISSUES
A. CONFIDENTIALITY OF INFORMATION SUBMITTED
IN CONJUNCTION WITH PREMANUFACTURE NOTICES
1. Substantiation of Certain Confidentiality Claims
As indicated in Section B-2 of Part II of the
Preamble, EPA is proposing to require persons asserting
confidentiality claims for the specific chemical iden-
tity of substances, and for health and safety data, to
provide substantiation for those claims in the form of
written answers to specific questions. Other informa-
tion claimed as confidential would not need to be
substantiated at the time of submission. Sub-
stantiation of these claims would be required only if
the Agency receives a Freedom of Information Act (FOIA)
request for such information.
In the inventory reporting rules, EPA required each
person claiming confidentiality for an item of informa-
tion to certify on the form that certain statements, as
applied to the piece of information, were true. These
included statements that a piece of information was not
in fact public, that steps were being taken to maintain
secrecy, and that release of the information could harm
the business of that person. In addition to this re-
quirement, persons who asserted a claim of con-
fidentiality for specific chemical identity of a
159
-------
substance were required to provide responses to 11
questions designed to help EPA determine whether the
Agency should keep the identity confidential for
purposes of the inventory. Both types of
substantiation represented a departure from traditional
EPA practice. EPA does not generally require
substantiation of a claim of confidentiality until EPA
receives FOIA requests for items of information.
EPA1s proposed premanufacture notification policy
concerning the substantiation of confidentiality claims
for specific chemical identity is similar to that
enunciated under the inventory. In addition EPA is
proposing a policy concerning substantiation of
confidentiality for information contained in health and
safety studies.
EPA's substantiation proposal for premanufacture
notices is based on both policy and legal
considerations. First, for each of these types of
information there is strong evidence that Congress
intended public disclosure of the data to the extent
possible. Second, because EPA expects a high volume of
requests for disclosure, EPA must have the
substantiation readily available in order to reduce the
administrative burden of responding to FOIA requests.
Third, EPA must be prepared to respond to these
requests speedily. By including in TSCA provisions
such as the §5(d)(2) Federal Register notice, Congress
160
-------
evinced a decision that the public should be involved
in the premanufacture review process to the extent
possible. EPA will strive to assure that
non-confidential information be available to the public
as soon as possible.
Finally, the substantiation burden is further
justified by the need to discourage ill-founded claims.
Substantiation aids the submitter in understanding the
findings which must be made to support a
confidentiality claim. Experience with the inventory
reporting regulations indicates that detailed
substantiation requirements significantly reduced the
number of claims. This should result in a higher level
of public information, and a reduced burden on EPA to
evaluate and protect information erroneously claimed to
be confidential.
Alternatives
EPA considered requiring substantiation of a claim
of confidentiality for specific chemical identity and
information contained in health and safety studies to
be submitted only after receipt of an FOIA request for
the information.
However, as indicated above, EPA believes that this
policy would not accomplish a number of purposes EPA
believes necessary to an effective implementation of
TSCA:
161
-------
speedy response to FOIA requests
- lessened administrative burden on the
Agency
discouragement of overly broad
confidentiality claims
EPA also considered the alternative of only
requiring detailed substantiation at the time of
asserting confidentialty for a specific chemical
identity. A confidentiality claim for a health and
safety study would be substantiated only upon receipt
of a FOIA request. However, EPA does not intend to
await receipt of a FOIA request before reviewing
confidentialty claims asserted with respect to health
and safety data. When EPA receives, in conjunction with
a premanufacture notice, a health and safety study, the
Agency will immediately place the study (or a "second
copy" of that study, provided in accordance with
proposed §720.40(b)) in a public file. At that time,
if a confidentiality claim had been asserted for any
information which was unrelated to the health and
environmental effects of the substance (see §720.43(a)
of the proposed rules), EPA will immediately begin to
review the basis for that claim. This proposed policy
of immediate review of confidentiality claims for basic
health and safety study information necessitates
submission of substantiation of the claim in
conjunction with the premanufacture notice.
162
-------
As described in Part 3 of this section, EPA has ad-
dressed the question of confidentiality for technical
use information by requiring persons to submit non-
confidential information on exposures of a substance in
its place.
Finally, EPA considered extending the sub-
stantiation requirement to claims concerning the con-
fidential uses of new substances. By mandating EPA to
include use information in the 5(d)(2) Federal Register
notice (subject to §14 restrictions on disclosure of
confidential information), Congress evidenced a strong
desire to provide this information to the public and a
sustantiation requirement would assist the Agency in
reviewing claims for confidentiality expeditiously.
As part of this procedure, EPA seriously considered
requiring persons who assert confidentiality claims for
some types of exposure and release data to substantiate
such claims simultaneously with the submission of the
information.
However, EPA is not proposing such a requirement at
this time for several reasons. The bulk of the
information in the premanufacture form may be described
as "exposure" information, and a requirement for item-
by-item substantiation may be very burdensome. EPA be-
lieves it may be better either to require
substantiation only for certain limited types of
163
-------
information, or to devise a streamlined method of sub-
stantiation. The Agency specifically requests comments
on which types of exposure information in the form
should be subject to substantiation requirements at the
same time as assertion of a claim of confidentiality
and how any such required substantiation could be ac-
complished in the least burdensome manner.
Substantiation Questions
EPA's proposed procedures will require persons claiming
confidentiality to address the following questions, as
appropriate.
Substantiation of Claim of Confidential Identity (Prior
to Manufacture)
1. What harmful effects to your competitive position,
if any, do you think would result from the identity of
the chemical substance you reported to EPA in your
premanufacture notification being disclosed to the
public? How could a competitor use such information,
given the fact that the link between your company and
the chemical identity can be kept confidential? What
is the causal relationship between the disclosure and
the harmful effects?
2. How long should confidential treatment be
given? Until a specific date, the occurrence of a
specific event, or permanently? Why? [Note, a new and
separate claim of confidentiality, and appropriate
substantiation, must be made once this chemical
164
-------
substance is manufactured for non-exempt commercial
purposes; see §740.41(b).1]
3. Has the chemical substance been patented? If
so, have you granted licenses to others with respect to
the patent as it applies to the chemical substance? If
the chemical substance has been patented and therefore
disclosed through the patent, why should it be treated
as confidential during the period prior to manufacture?
4. Has the identity of the chemical substance
been kept confidential to the extent that your
competitors do not know that it will be manufactured
for a commercial purpose by anyone?
5. Has the fact that someone is planning the
manufacture of this chemical substance for commerical
purposes been made available to the public, for example
in technical journals or other publications?
6. What measures have you taken to prevent
undesired disclosure of the fact that you will be
manufacturing this substance for a commerical purpose?
7. To what extent has the fact that you will be
manufacturing this chemical substance for a commercial
purpose been revealed to others? What precautions have
been taken regarding those disclosures? Have there
been public disclosures to competitors?
8. Have samples of this substance left the
premises of your company for any reason? If so, what
measures have you taken to guard against discovery of
165
-------
its identity?
9. Has EPA, another federal agency, or any
federal court made any pertinent confidentiality de-
terminations regarding this chemical substance? If so,
please attach a copy of such determinations.
Substantiation of Claim of Confidential Identity
In a Health and Safety Study (After Manufacture Begins)
1. Will disclosure of the specific chemical
identity in your health and safety study disclose a
process used in the manufacture or processing of a
chemical substance or mixture? If so, describe how
disclosure of the chemical identity would disclose the
process.
2. What harmful effects to your competitive
position if any, do you think would result from
disclosure of this process? How would a competitor use
this information? Would the effects be substantial?
What is the causal relationship between the disclosure
and the harmful effects?
3. Will disclosure of the specific chemical
identity in your health and safety study disclose, in
the case of a mixture, the proportions of the mixture
comprised by any of the chemical substances in the
mixture? If so, describe how disclosure of the
chemical identity would disclose proportions.
166
-------
4. What harmful effects to your competitive
position, if any, do you think would result from
disclosure of the proportions? How would a competitor
use this information? Would the effects be
substantial? What is the causal relationship between
the disclosure and the harmful effects?
5. How long should confidential treatment be
given? Until the occurence of a specific event, until
a specific date, or permanently? Why?
6. Has the chemical substance or the process been
patented? If so, have you granted licenses to others
with respect to the patent as it applies to the
chemical substance or the process? If the chemical
substance or process has been patented why should it be
treated as confidential?
7. Has the nature of the process or the
proportions been kept confidential? What measures have
you taken to guard against disclosure?
8. To what extent have the process or proportions
been revealed to others? What measures have you taken
with regard to these disclosures to protect from
further disclosure?
9. In the case of proportions of a mixture, does
the mixture leave your facilities and become available
to the public or your competitors? If so, can the
167
-------
mixture be analyzed to identify the proportions of the
chemical substances in the mixture? If so, why are
they confidential?
Substantiation of Claim of Confidentiality
For Health and Safety Data (Other than chemical
identity
1. Will disclosure of the information claimed as
confidential in your health and safety study disclose a
process used in manufacturing or processing a chemical
substance or mixture? If so, describe how the
information will disclose the process.
2. Will disclosure of the information claimed as
confidential in your health and safety study disclose
the proportions of a mixture comprised by any of the
chemical substances in the mixture? If so, describe
how the information will disclose the proportions.
3. Will disclosure of the information claimed as
confidential in your health and safety study disclose
information which is not related in any way to the
effects of a substance on health or the environment?
If so, describe how the information will disclose this
information.
4. Has any of the information claimed as
confidential been disclosed on a patent? If so, why
should it be treated as confidential?
5. Is this information available to the public or
your competitors without restriction?
168
-------
6. How do you protect this information from
undesired disclosure?
7. Has this information been disclosed to others?
If so, what precautions have you taken in regard to
these disclosures? Has the information been disclosed
to the public or competitors?
8. In the case of information concerning
proportions of a mixture comprised by one or more new
chemical substances, does the mixture leave the control
of your company and move in commerce? If so, can the
mixture be analyzed to determine the proportions of the
new chemical substance in it?
9. Has EPA, another federal agency, or any
federal court made any pertinent confidentiality
determinations regarding this information. If so,
please attach copies of such determinations.
10. How long should confidential treatment be
given? Until a specific date, the occurrence of a
specific event, or permanently? Why?
11. What harmful effects to your competitive
position, if any, do you think would result from
disclosure of the process? The proportions?
Information not related in any way to the effects of a
substance on the health or the envrionment? How would
169
-------
a competitor use this information? Would the harmful
effects be substantial? What is the causal
relationship between disclosure and the harmful
effects?
2. Confidentiality of Specific Chemical Identities
In Section III-A of the Preamble, EPA discussed in
some detail its proposed policy concerning the
treatment of confidentiality claims asserted with
respect to the specific chemical identity of chemical
substances. That discussion on the statutory
provisions which EPA considered relevant to resolving
such an issue, discussed the policy considerations that
were taken into account, and outlined EPA's proposed
resolution of the confidential identities issue. In
addition, in the preamble EPA introduced, but did not
discuss, the broad range of alternatives policies which
the Agency examined.
The purpose of this section of the support document
is to supplement the preamble discussion. First, EPA
will discuss several aspects of the Agency's proposed
confidential identities policy. Next, the Agency will
discuss several considerations of policy which favor
broad disclosure of the specific chemical identities of
substances for which premanufacture notices are
170
-------
received, and which EPA took account of in its proposed
identities policy. Finally, in this section the Agency
is including a further disussion of the alternatives to
the confidential identities policy which is being
proposed, focusing on the likely advantages and
disadvantages of each.
a. Clarification of Scope of §14(b) of TSCA, and
EPA's "Confidential Identities" Policy
As indicated in the Preamble, §14(b) of the Act by
its terms, applies to studies which relate to
substances which have been offered for commercial
distribution, for which testing is required under §4,
and for which premanufacture notification is required
under §5.
EPA has interpreted the meaning of "offered for
commercial distribution," as the phrase is used in
§14(b), in 40 CFR 2.306(a)(3)(i) (see 43 FR 39997).
Substances "offered for commerical distribution"
include those manufactured, processed, or imported for
distribution in commerce, including for test marketing
purposes and for use in research and development, or
for use by the manufacturer, importer, or processor,
including for use as an intermediate.
In discussing the proposed premanufacture
171
-------
notification policy, the Preamble states that EPA's
policy, established by §710.7 of the inventory
reporting requirements, which provided that the Agency
would hold specific chemical identity confidential if
certain requirements were met, would continue with
respect to premanufacture notices in the absence of
submission of a health and safety study. This language
applies specificaly to the submission of a health and
safety study concerning the substance for which a
premanufacture notice is submitted, and must be
qualified with respect to studies submitted to the
Agency which were performed on other substances.
Under the provisions of §720.23, EPA expects that
some premanufacture notices will include health and
safety studies on byproducts, impurities, and other
substances related to the manufacture, processing,
distribution in commerce, use, or disposal of the
substance for which a notice is submitted, but which
would not themselves be subject to §5 premanufacture
notice requirements. Unless these other substances
were themselves "offered for commercial distribution"
(as defined above), or were subject to a testing
requirement promulgated under §4 of TSCA, the
confidentiality claim would not be subject to the
limitations of §14(b).
172
-------
b. Proposed Modification of Generic Name Policy
At §720.41(a)(2)(i)(B), and as discussed in Section
III-A of the Preamble, EPA is proposing that generic
names not only satisfy the pre-existing inventory
standard of being only as generic as necessary to
protect the confidential business information, but in
addition provide as much information as possible on
toxicologically significant aspects of a new
substance's structure. Such a policy could provide
important additional information on the composition of
substances to the public in those cases where the
specific identity was confidential. Under the generic
name policy adopted for inventory reporting purposes,
the ability of a name to reveal toxicologically
significant structural data was not specifically
discussed.
The key to this revised policy is that not all
aspects of a substance's structure are equivalent in
their toxicological potential. Certain functional
groups and steric isomers are known to have significant
impacts on the biological activity of chemicals. A
toxicologist1s evaluation would be influenced by the
presence of halogens, metals, epoxides and other
functional groups. It is conceivable that a generic
name could be asssigned which would disclose the
173
-------
characteristics of the compound which are of particular
interest to toxicologists or environmental scientists,
without revealing confidential information. For
example, polyhalogenated biphenylamine and
polysubstituted biphenyl may be equivalent in
disguising trade secret information. However, the
former is more meaningful to a toxicologist.
How could such a policy be implemented? Many
companies submitting notices possess staff scientists
who could participate in the generic naming process, by
identifying and ranking structure features of
toxicological significance. EPA also could encourage
manufacturers to consult with toxicologists either
within the Agency or elsewhere in making this
determination. Finally, the Agency could revise the
Generic Name Guidelines to assist submitters in
achieving this new goal, one advantage of revised
Generic Name Guidelines would be to make industry
aware, in advance, of those naming methods likely to be
accepted by Agency reviewers.
Overall, EPA believes that the proposed policy
would allow somewhat more thorough public review of new
chemical substances. However, EPA recognizes that the
approach is at best an incomplete answer. Many
174
-------
toxicologically significant aspects of a chemical may
still be disguised because the submitter believes them
necessary to maintain confidentiality. In addition,
replication of a test performed on such a substance
would be impossible.
EPA specifically requests comments on how it could
modify its Guidelines for Creating Proposed Generic
Names, and its procedures for reviewing proposed names,
to insure that the maximum possible toxicological
information is revealed.
c. Procedures for Ensuring Expeditious Disclosure
of Non-Confidential Identity Information
During the pre-proposal period, several public
interest groups expressed the concern that a person
might assert an unfounded, broad confidentiality claim
for identity, or propose a name that was overly
generic. Their concern was that by the time "he
problem was resolved and the maximum information made
available to the public, the premanufacture period
would have expired, and the public would be denied
effective opportunity to evaluate the substance. It is
true that if EPA denies a claim, or seeks a narrower
name, the process may take several months - even if the
submitter does not litigate the issue.
175
-------
The rules address this practical problem in several
ways. First, §720.41(a)(2) establishes a voluntary
procedure for pre-notification consultation about what
generic description EPA should use for the §5(d)(2)
notice and other public disclosure during the
premanufacture period.
Advantages of pre-consultation include the fact
that EPA would be able to determine, on a case-by-case
basis, what type of generic name would be appropriate
for a given substance. This is especially important if
EPA, as suggested above, adopts the proposal that
generic names be as toxicologically revealing as
possible. Pre-consultation would be of value to
industry because uncertainty about EPA's handling of a
claim of confidentiality for identity could be resolved
prior to submission of the notice. Publication of an
acceptable generic name in the intitial §5(d)(2)
Federal Register notice could remove the need for EPA
to publish an amended notice under §720.32(c), and
remove a possible basis for EPA's extension of the
notification period under §720.35 of the proposed
rules.
Second, as discussed above, EPA is proposing that
persons substantiate all claims of confidentiality with
respect to specific chemcial identities. This will
discourage ill-founded claims while at the same time
allowing EPA to review expeditiously those claims which
are made.
176
-------
d. Considerations Favoring Disclosure of Specific Chemical
Identities
In the Preamble, EPA discussed various policy con-
siderations which led the Agency to conclude that a
mechanical reading of the statute in favor of disclo-
sure of confidential chemical identities was not an
appropriate interpretation. As the preamble explained,
EPA's proposed policy represents a balancing of interests
favoring and opposing disclosure. Those considerations
which the Agency believes would favor disclosure are
discussed below. The factors in favor of non-disclo-
sure are discussed in the Preamble.
Congress believed that, to the extent possible,
substances should be evaluated and regulated prior to
the commencement of commercial manufacture or import -
before significant exposures could occur, and while a
prohibition of limitation on a substance's production
or use would cause a minimum of economic disruption.
It is clearly in the interest of the Agency, then, to
maximize the availability of information from all sources,
as soon as possible in the course of the introduction
of a new substance into commerce.
177
-------
If EPA were to disclose the specific chemical identity
of a new substance as part of a health and safety study, the
Agency would enable persons outside EPA to submit additional
information concerning the chemical substance. This may
include information which is neither known to nor reasonably
ascertainable by the notice submitter. Even if persons out-
side EPA have not conducted tests, they may be able to
perform a valuable service by evaluating the chemical and
the tests previously performed on it. EPA has identified
several ways in which public input could assist chemical
review:
- assist in identifying structure/activity re-
lationships;
- assist in determining whether the tests or testing
methods for health and safety studies are appropriate,
given the characteristics of the substance;
- replicate tests which have been performed, or per-
form additional testing which has not been undertaken
by the submitter of a premanufacture notice.
In addition to assisting EPA's evaluation of new sub-
stances, disclosure of identity in the context of health and
safety studies would promote public oversight of EPA de-
cisionmaking. The Agency does not intend to adopt a
178
-------
passive stance, merely providing information to the public
and reacting according to the input the public provides.
Instead, it will evaluate the chemicals aggressively, based
on all the information available to the Agency. However,
Congress clearly intended public oversight, as evidenced
by 85(d) (2), 814 (b) and §21; the latter provision provides
for "citizens' petitions" to induce Agency regulatory
action on substances.
Finally, 814 (b) also seems to reflect a policy of
providing the public with information for "self-help"
with regard to chemical substances. The public has a
legitimate concern with protecting itself from exposure
to chemical substances which have been shown by health
and safety studies to present a risk of injury to health
or the environment, but which EPA has not regulated. For
example, if a manufacturer produces a chemical which EPA
has identified as a possible carcinogen, consumers may
wish to avoid use of products containing the substance,
and workers may use protective equipment or request their
employers to implement controls over the substance or to
monitor exposure levels. By the nature of the problem the
need for information for "self-help" purposes becomes most
179
-------
significant after manufacture or distribution of the
product has begun.
e. Alternatives to Basic Confidential Identities Policy
Resolution of the policy with respect to EPA's
treatment of confidential chemical identities was among
the most controversial issues confronting EPA prior to
proposal of these rules. As a result, an unusually large
number of alternative approaches were examined closely.
Though the alternatives below are not being proposed,
EPA has not foreclosed consideration of them. Depending
on the comments received, one or more of these may be
included in the rule as finally promulgated.
Alternative 1: Do not disclose a specific chemical identity
which is claimed confidential as part of a health and safety
study before or after commencement of manufacture.
Under this approach EPA would continue to grant
confidential treatment to chemical identities, even for
substances in health and safety studies, after commence-
ment of manufacture, on the basis of the broad "business
confidentiality" justifications recognized by 814(a),
rather than the narrow "process" and "mixture" grounds
contemplated by 814(b). Such a policy would be to the
advantage of the industry.
180
-------
However, EPA questions the legal basis for such a
policy. Industry representatives justify this position
on the grounds that identity is not a part of a health
and safety study. As indicated in the Preamble, EPA does
not agree.
Legal questions aside, this policy would deny the
public important information about chemicals to which
the public may be exposed, and would further hamper the
ability of the public to contribute information to EPA
and exercise effective oversight over EPA's chemical
review process.
Alternative 2: Disclose specific identity as part of a
health and safety study both prior to and after commencement
of manufacture unless such disclosure would reveal
confidential "process," or "mixture" proportion, data.
This alternative would limit confidentiality for
specific chemical identity from the time of premanufacture
notice submission to those grounds specifically mentioned
in §14(b). Because of the time frame involved, the §5(d)(2)
notice might still utilize a generic name, but the specific
chemical identity would be disclosed after EPA's denial of
the claim (and the elapse of the 30-day period, assuming the
submitter did not litigate the question).
181
-------
This policy could increase the amount of information EPA
would receive from persons outside the Agency at a time when
the Agency could regulate a substance prior to commencement
of manufacture.
However, this policy could impose significant costs on
manufacturers, and burden innovation. The premanufacture
period is the most sensitive period in development of a
chemical. Disclosure prior to commercialization could
lead to a loss of commercial advantage, and some manufac-
turers have asserted that premature disclosure could pre-
vent U.S. companies from obtaining patents in some foreign
nations. The Agency would have to weigh this potential harm
against the helpful data which may be submitted by the public
as a result of this disclosure.
It is important to note that public disclosure of
identity by EPA would not reduce the amount of health and
safety data which domestic manufacturers submitting pre-
manufacture notices would submit to EPA. Submittal of
such data would be mandatory under §720.23 of the proposed
rules. However, EPA would be requiring importers to
request foreign manufacturers and suppliers to submit
health and safety studies to EPA. These foreign companies
are under no legal duty to submit these studies. It is
possible that the greater the degree of confidentiality
afforded to health and safety studies, the greater the
likelihood that foreign firms will be cooperative.
182
-------
Alternatives for Limited Disclosure of Chemical Identity
in Health and Safety Studies
The two alternatives discussed above are of the
black-white variety: EPA either discloses identity (except
where a confidentiality claim is based on "process" or
"mixture" proportion grounds) to all persons regardless
of the nature of their interest, or refuses to disclose
it, again without consideration of the relation of their
interest to the purposes of S14(b). Under the approach
proposed, environmental and public health interest groups,
would be denied access to specific chemical identity in
the premanufacture period in spite of the fact that some
manufacturers insist that their real concern is access
by competitors; after commencement of manufacture com-
petitors would have access to all identity information
which does not disclose "process" or "mixture proportions,"
even though the law's purpose is to assist in public
evaluation of the health and environmental effects of new
substances.
The alternatives discussed below possess a common
theme, in that they would attempt to move toward a more
focused approach, permitting disclosure only to persons
who do not have a commercial interest in chemicals and
are operating in the "public interest." Major weaknesses
of all of these middle-of-the-road approaches are their
administrative complexity and lack of control over further
disclosure.
183
-------
Alternative 3; Establish a panel of experts with no
commercial interest in chemicals to review all health and
safety studies on new chemical substances prior to the
commencement of manufacturefor commercial purposes.
All non-government members would be considered
"contractors" so as to permit disclosure under S14(a)(2).
Persons with access to the information would sign con-
fidentiality agreements promising to refrain from further
disclosure of confidential information. The panel could
include representatives of public interest groups which
could help satisfy the public desire for participation
in the chemical review process. In addition, the panel
might improve the quality of EPA's review because it would
be able to draw upon a larger body of expertise than that
available to EPA alone. On the other hand, while such a
panel would increase oversight and public input, it would
still be narrower than if the information was available to
the public at large, and would not contribute significantly
to oversight by public interest groups. In addition it is
not clear what the role of this panel would actually be,
or how it could legally be constituted and paid.
184
-------
Alternative 4; Disclose specific chemical identity as part
of a health and safety study/ both prior to and after
commencement of manufacture to any person who can establish
a bona fide public interest in his obtaining the identity
and who has no commercial interest in chemical substances.
This process could be initiated by a petition from any
member of the public who could show that there, was a public
interest in his obtaining the specific identity of a
substance, and who could demonstrate that he did not have
any commercial interest in chemicals. If EPA, after an
initial review, determined that the petition had merit, it
would notify the submitter of the identity information.
After providing that person an opportunity to respond, EPA
would make its decision on disclosure, taking into con-
sideration the bona fide public interest shown, the
petitioner's proposed procedures for preventing further
disclosure of the confidential information, and the
commercial harm likely to be incurred by the submitter if
the information was released. If EPA would decide to dis-
close the information to the petitioner, EPA would give
the submitter advance notice of this fact.
This scheme would shape EPA's confidential identity
policy to the conflicting imperatives of the statute.
185
-------
Persons seeking to evaluate health and safety studies and
the effects of substances in order to prevent unreasonable
risks would generally be able to obtain needed information,
competitors would not. EPA, not the submitter, would
determine if the information should be disclosed.
The major drawbacks of the system are administrative
complexity and drain upon EPA's resources. EPA likely
would be called upon to process a great many such peti-
tions, making complex decisions balancing various legi-
timate interests. It is not apparent that EPA will be
able to dedicate the resources necessary without detract-
ing from its review of premanufacture notices. In addition,
in agreeing to restrict further disclosure of the data,
"public interest" petitioners could subject themselves to
legal and financial liabilities if information was released.
Alternative 5; Disclose specific chemical identity as part
of a health and safety study with the consent of the submitter.
Under this procedure, EPA would not have an active
role in determining release of identity for a health and
safety study. Instead, EPA would serve as a conduit, or
middleman, between a person claiming to represent the
"public interest" and a person who had asserted a
claim of confidentiality.
186
-------
If a person made a prima facie case that there was a
public interest in his obtaining certain data, and that
he had no business or competitive interest in the informa-
tion, EPA would relay his request to the submitter of the
data. The submitter would review the basis of the request
and the procedures proposed by the requester to prevent
further disclosure of the information. If the person
agreed, the information would be released, typically to
a contractor or consultant, designated by the requester,
who would pledge not to reveal the confidential identity.
The person receiving the information could evaluate it
and prepare a report for submittal to EPA, with public
.disclosure of those portions that would not compromise
confidentiality.
This alternative shares some of the advantages
associated with alternative 4 - that is, it could serve
as a means of getting important health and safety informa-
tion to persons who would use it properly, without reveal-
ing confidential business information to competitors.
Public interest groups should find this greater access
useful, even if they are not able to make unrestricted
use of the confidential information, or have to rely
on a contractor as a condition of the disclosure.
187
-------
Finally, EPA's more limited role should substantially
reduce the administrative burden.
The major liability of the scheme is that it is
voluntary, depending on the submitter's cooperation.
In addition, as with alternative 4, public interest
groups would be forced either to sign confidentiality
agreements which could subject them to liability, or
to rely on outside consultants to review confidential
identity data.
Procedural Alternatives
The two alternatives discussed immediately below are
distinguished from the proposed policy on the grounds of
procedure, and not because they contemplate a substantive
difference in the criteria the Agency would use for
releasing identity of a substance in a health and safety
study.
Alternative 6: Rather than routinely making identity
available, await receipt of an FOIA request before
determining whether to disclose identity after commencement
of manufacture.
This alternative could function in conjunction with
the confidential identities policy proposed in §720.41 and
188
-------
8720.43, and might also be combined with some of the other
alternatives discussed above. Under this approach, upon
commencement of manufacture EPA would not review auto-
matically a confidential identity claim to determine
whether to hold identity confidential based on "process"
or "mixture" grounds. Instead, the Agency would maintain
the generic name on the inventory and in connection with
any health and safety study on file. However, if a person
requested disclosure of specific chemical identity as part
of a health and safety study, EPA at that time would review
the confidentiality claim, and would deny it if it was not
justified under §14(b). At that point EPA would amend the
inventory to reflect this new determination. This alterna-
tive would not change EPA's proposed policy on the grounds
on which confidentiality could be granted, but would be
an exercise in EPA's discretion as to when that review
would take place.
This system would preserve the confidentiality of an
unknown number of identities, or delay their disclosure,
depending on when, or if, EPA received a public request
for this information. EPA would, at the same time, save
the resources needed to review claims and make determina-
tions for substances in which no person expressed an
interest.
189
-------
The disadvantages of this approach depend largely
on the degree to which persons, in fact, request disclo-
sure of identities: the higher the percentage of re-
quests, the lesser the utility of the approach. For each
identity requested EPA would be required to review identity
twice - once for the inventory (on general business confi-
dentiality grounds) and later in a health and safety study
context on 814(b) grounds. Then, if the confidentiality claim
was denied, EPA would be required to amend the inventory.
A further negative result would be that persons with a
legitimate interest in studying the specific chemical
identity would encounter some delay in obtaining the
information, even where it was subject to disclosure
under 814(b) of the Act, and these rules. People using the
inventory would be inconvenienced and have to use the "bona
fide" system to determine if a mixture is on the inven-
tory.
Alternative 7; After commencement of manufacture, maintain
the generic name on the inventory even if the specific
identity has been released in connection with a health and
safety study.
Under this approach, EPA would treat the determina-
tion of confidentiality for the inventory purposes separately
190
-------
from the confidentiality determination with respect to
health and safety studies. If EPA determined that the
identity would disclose confidential business information,
it would publish a generic name, not the specific name, for
inventory purposes, even if the identity did not reveal
"process" or "mixture" information. However, the Agency
would then release the identity in connection with a health
and safety study.
The basis for EPA's consideration of this option is the
fact that there may not be necessarily any legal requirement
that if a specific chemical identity is disclosed in a
health and safety study, it must also be included on the
inventory. There is however a factual and practical
connection between these facts in virtually all cases.
Disclosure of identity as part of a health and safety
study may reveal precisely the same confidential fact that
a generic name on the inventory would hide - the fact
that a specific chemical substance is manufactured or
imported for a non-exempt commercial purpose.
If an identity is available in the context of a health
and safety study, but not on the inventory, a person will
be required to exert a somewhat greater effort to obtain
the data. Rather than examining a published list (or one
amenable to computerized analysis), he will be required
191
-------
to request a study, or examine the study in EPA's public
file room. This extra effort appears unlikely to deter
sophisticated competitors. EPA specifically solicits
comments on how maintenance of confidential identities,
separate from health and safety study determinations,
would afford manufacturers or importers a significant
additional degree of production.
Alternative Not Requiring Disclosure of Specific Chemical
Identity.
The following alternative was considered as a means of
providing information to the public that would partially
replace the information lost by the public by use of
generic identities.
Alternative 8; Require a minimum level of testing,
including physical and chemical properties and basic health
and environmental effects, for all new chemical substances
whose identities are claimed as confidential.
EPA could utilize the authority of 84 to mandate
a minimum level of testing for new chemicals whose
identity was claimed as confidential. This could include
boiling point, melting point, octanol/water partition
coefficient, vapor pressure, saturated vapor density,
pH and pK, and basic effects screening tests.
192
-------
The results of these tests, submitted with the 85
premanufacture notice, would be available to the public
in accordance with §14(b).
Physical and chemical properties data can be very
useful in evaluating tests and testing methodologies;
performance of basic screening tests could satisfy many
public concerns about new chemicals, and submittal of
such results could expand information available to EPA
as well. Also, these data would be relatively cheap
to provide.
However, the public may gain little from this policy.
For many high-volume, high-exposure chemicals, (the ones
the public may be most concerned about) many of these
basic tests should already be submitted, and this data
would already be available. On the other hand, identity
will still be a major concern in evaluation of those
studies that have been performed.
193
-------
f. AdvanceAssertion of Claims of Confidentiality
of Specific Chemical Idejrtity for the inventory
When EPA receives a Notice of Commencement of
Manufacture or Import under section 8(b) of the Act and
§720.52, it must add the substance to the inventory as
of the earliest date when it is manufactured or
imported for a non-exempt purpose. At the same time,
if the specific identity is entitled to confidential
treatment, EPA must assure that the generic name to be
substituted for it on the inventory is only as generic
as necessary. Use of a narrower generic name would
lessen the number of persons who might be required to
utilize the procedures of §720.12(b) to ascertain if a
substance they intend to manufacture is already on the
inventory; at the same time, it would provide the
public with as precise information as possible
concerning what substances are on the inventory.
The problem of determining the adequacy of generic
names is the same one that was faced in assembling the
inventory. However, the addition of new substances to
the inventory in a timely fashion poses a new problem.
If EPA allowed a person to assert a confidentiality
claim in the Notice of Commencement of Manufacture, EPA
would not be able to evaluate the claim, give 30 days
notice to the submitter, review the adequacy of the
generic name, and, at the same time, immediately add
the appropriate name to the inventory. Therefore
194
-------
under §720.41(b) EPA is proposing to require the person
to assert his confidentiality claim at least 60 days
prior to commencement of manufacture. EPA will thus
have an opportunity to complete its review of the
confidentiality claim and the proposed generic name and
notify the submitter before commencement of
manufacture.
195
-------
3. Information on Uses of the New Chemical Substance:
Confidentiality and Substitute Information
In section II-D-3 of the Preamble, which described
the proposed contents of the Federal Register notices
required by 85(d)(2) of the Act, EPA noted that it would
not disclose information on uses of a new chemical sub-
stance for which a valid claim of confidentiality was
asserted. Instead, the Agency would require the sub-
mittal, in a specially designated section of the form
(Part I, Section D of the Premanufacture Notice Form),
of non-confidential summary information on human expo-
sures to, and environmental release of, the new substance,
This proposed approach is based on EPA's belief
that Congress' intent in §5(d)(2) was for EPA to publish
use data as an indicator of likely exposures to the sub-
stance - but to disseminate this information only if this
was not inconsistent with the legitimate interests of the
submitter in confidentiality. EPA believes its proposed
policy will accomplish these conflicting purposes, pro-
viding the public with useful information, while avoid-
ing the severe disruption of innovation and marketing
which could result from a disclosure of technical use
information.
In arriving at its "use" data policy set out in
§720.42 and §720.32 (b), the Agency evaluated a variety
196
-------
of alternative approaches, discussed below. EPA is
strongly committed to this proposed approach, believing
it to possess significant advantages over other alterna-
tives. EPA is less committed to the particular exposure
and release questions contained in the Federal Register
notice section of the form.
The Agency specifically solicits comments with
respect to other exposure data that may be useful, and
concerning whether certain types of exposure data, alone
or in combination, are considered to be confidential.
To the extent that a person believes these exposure
questions will result in confidentiality problems, alter-
native formulations of the questions are requested. In
addition, EPA requests comment on how the Agency should
assure that persons submitting premanufacture notices
provide exposure and release characterizations that rea-
sonably reflect the data otherwise submitted to EPA. For
example, should submitters be required to substantiate
that data provided in the Federal Register section of
the notice is as detailed and complete as it is possible
to provide while preserving confidential business informa-
tion?
197
-------
A11 e r n a t i ve s
To arrive at this proposal, EPA considered several
alternative approaches. First, the rules could provide
that certain types of basic use information would not be
entitled to confidentiality. Second, EPA could recognize
that use data could be confidential, as in the proposed
approach, but make no special effort to require the sub-
mitter to develop other use or exposure data suitable
for public disclosure in the §5 (d) (2) Federal Register
notice. Third, the Agency could require submitters to
provide generic description of uses only, and not exposure
information per se. Finally, EPA could require the sub-
mitter to provide more extensive, detailed exposure informa-
tion.
EPA questions the statutory basis for the first
alternative. Section 14 does not specifically address
use information, so the Agency must assume that the
confidentiality of this information is to be controlled
by §14(a). That section provides that any information
submitted to EPA which is exempt from disclosure under exemp-
tion (b)(4) of the Freedom of Information Act (5 U.S.C.
552 (b) (4)) shall not be disclosed, except in certain
limited situations. This FOIA exemption applies to "trade
secrets and commercial or financial information obtained
from a person and priviledged or confidential." While each
198
-------
piece of information must be judged individually, there is
reason to believe that much technical use information
would fall in this category. None of the exceptions
(§14(a)((1)-(4)) would allow the routine public disclosure
of use information. Neither does 85(d)(2) provide such
authority; its requirement to publish use information
is, by its terms, "subject to 814."
Nor do policy considerations favor such an approach.
The policy of TSCA, as stated in §2(a)(3), is to fulfill the
primary purposes of the Act without unduly impeding inno-
vation. EPA recognizes that some of the use data the
Agency is requiring to be submitted on the premanufacture
form, while necessary to meet EPA's needs in determining
whether to control a new chemical substance, may be very
commercially sensitive, and that public disclosure may
dampen incentives to develop new substances. EPA should
consider imposing such burdens only if necessary to
achieve the purposes of the Act.
While the second alternative would not run afoul of
any explicit statutory prohibition, EPA does not believe
it would effectively implement the Congressional will.
The statute gives EPA ultimate responsibility to evaluate
new chemicals and determine which controls may be nec-
essary; however, as has been discussed elsewhere, TSCA
also contains numerous provisions for public oversight
of EPA's determinations.
199
-------
In addition, given the limited amount of data which
may be available on some new substances, EPA cannot afford
to ignore the possibility that inclusion of use or expo-
sure data in S5(d)(2) Federal Register notice may trigger
a submission of significant new data on the health and
environmental effects of the substance by a member of
the public.
The third alternative - publication of only a "generic"
description of uses when the technical use information was
shown to be confidential - was determined to be deficient
in two ways. First, it may be difficult for persons to
develop useful generic descriptions of uses. The problems
encountered in developing and interpreting generic uses
are not analogous to those encountered in developing
guidelines for generic names, where there existed a great-
er theoretical background and preexisting principles for
classification. The Agency, in conjunction with contractor
support, has developed a use classification scheme, which
was published for comment during the summer of 1978 (43 FR
32222, July 25,1978). However, this scheme was not developed
for the purpose of providing non-confidential use descriptions,
and it is not clear that the descriptions would be sufficiently
"generic" to suit such a purpose. Second, the Agency
believes that it may be possible to provide exposure
data more effectively by doing so directly, rather than by
trying to develop a generic description which would reveal
similar information.
200
-------
Finally, EPA considered whether other more detailed
exposure-type information included on the premanufacture
notice forms should be required to be reported in the
§5 (d) (2) notice section of the form. This information,
included elsewhere on the forms in sections pertaining
to worker exposures in manufacturing and processing opera-
tions, consumer exposures, and environmental releases at
various stages of the substance's life cycle, includes
information on levels of concentration of the substance,
discharge rates, sites of discharge, etc., of the new
substance, in addition to similar information on certain
related chemical substances. On the other hand, the
Federal Register section of the notice, as proposed,
requests only information on the overall number of per-
sons exposed in several categories (workers, consumers)
and the percentage of the substance released to the en-
vironment at various stages of the substance's life.
EPA recognizes that inclusion of further exposure informa-
tion in the S5(d)(2) notice could assist public oversight,
and welcomes comment on which types of exposure data report-
ed on the form and not proposed to be published in the
Federal Register notice would be most important to the
public and amenable to reporting in a non-confidential
form.
201
-------
4. Additional Confidentiality Provisions (With Respect to
Health and Safety Studies)
EPA has previously discussed, in Section III-A of the
Preamble and elsewhere in this section of the Support
Document, its proposed confidentiality policy with respect
to disclosure of the specific chemical identity portion of
a health and safety study. The discussion which follows is
concerned with the application of 814(b) to non-identity
information. These provisions are contained in 8720.43(a).
Though confidentiality claims can be asserted for any
information included in a health and safety study, 8720.43
(a) states that EPA will deny confidential treatment to
information unless it would disclose confidential informa-
tion concerning the following:
a. "Processes used in the manufacturing or processing
of a chemical substance or mixture;
b. In the case of a mixture, the portions of a mix-
ture comprised by any of the chemical substances
in the mixture; or
c. Information which is not in any way related to
the effects of a substance on human health or
the environment, including the name of the sub-
mitting company, cost or other financial data,
product development or marketing plans, ad-
vertising plans, and use information..."
202
-------
The initial two of the above paragraphs are based directly
on the language of §14(b).
The third paragraph addresses information which does
not convey any data about the nature of the testing, or the
health or environmental effects observed. EPA is not
certain whether the inclusion of commercial and financial
information in a document which is otherwise considered to
be a "health and safety study" is likely to be a significant
problem. Under 8720.23, persons submitting notices may be
submitting health and safety data in a variety of forms.
For much of the data, the submitter will be required to
prepare a report in "full report format," or to prepare an
abstract in some cases. If the data have already been
published, he may submit a literature citation. In none
of these cases would EPA expect that the person would be
submitting data of the type addressed by S720.43(a)(3).
However, a person may substitute an existing report if the
study had been prepared prior to the effective date of
these regulations. It is possible that some of these existing
reports could contain data unrelated to the health and environ-
mental effects of the substance.
This provision is based on EPA's interpretation of
the Congressional purpose in adopting §14(b). The aim
of this section is to inform the public of information
with respect to the risks posed by certain chemical sub-
stances, so that the public could play a greater role in
the formulation of regulatory policy and protect them-
203
-------
selves from risks of a chemical. For these purposes,
the public should be informed of how the tests were
conducted and what type of results were observed. However,
revealing information of a purely business or commercial
nature would not serve any function related to the health
and safety purposes of the Act, and could have a signifi-
cant competitive impact in some cases.
204
-------
B. SIGNIFICANT NEW USE RULES (SNURS)
General
Congress recognized that use of an existing substance in
a manner significantly different from existing uses may
present new risks as a result of new exposures. Thus TSCA
§5(a)(l)(B) requires persons to notify EPA of any intent to
manufacture or process substances for uses which the Agency
determines by rule to be significant new uses. This enables
EPA to review signficant changes in exposures associated
with existing substances, before the changes occur. As in
the case of notification for a new substance, submittal of a
notice pursuant to a SNUR will not necessarily result in EPA
banning or otherwise restricting manufacture or processing
of the substance. However, if EPA takes any action under §5
with regard to a significant new use of a substance, the
Agency must do so within the same 90-day (or 180-day, with a
§5(c) extension) review period. In addition, for any SNUR
notice which does not result in an Agency prohibition or
limitation upon the manufacture, use, or disposal of the
substance, (pursuant to §5(g)) EPA will publish a statement
in the Federal Register. The statement will include the
Agency's reasons for not initiating action to prohibit or
limit the manufacture and use of the substance.
205
-------
EPA will issue SNURs (1) to require reporting for
selected existing chemical substances which may be produced
and used in a ways that may result in significant risks, and
(2) as a followup tool in conjunction with EPA's initial
review of new chemical substances. EPA intends to begin a
rulemaking on significant new uses during the latter part of
1979, initially for use in following new chemicals
substances. The Agency intends to follow the same
procedures in developing SNURs as have been used in
developing this proposed action, i.e., early participation
by the public, proposal of rule, public comment period, and
final rulemaking. Significant new use rules will require
persons to submit §5(a) notices which contain or reference
the types of information requested in the form now proposed
by the Agency for use by manufacturers of new substances.
However, it is possible that EPA will develop separate SNUR
forms, to reflect particular information needs and reporting
requirements for SNURs.
The following discussion concerns the use of SNURs as a
followup tool in conjunction with EPA's initial review of
new chemical substances.
206
-------
Relationship to Premanufacture Review of New Chemical
Substances
Under the Act, following premanufacture notice for a new
substance, once the substance appears on the inventory of
existing substances, anyone may manufacture it in any quant-
ity and for any intended use, without notifying EPA. If sub-
sequently there are significant departures from the man-
ufacture and use conditions described in the original notice
to EPA, and if these indicate that exposure may change
significantly, the Agency may decide to reevaluate its
decisions regarding the acceptability of the risks presented
by the substance. In those instances when EPA forsees the
need for such reevaluation, the Agency may issue a SNUR at
the time a substance is placed on the inventory of existing
substances, or shortly thereafter.
There are at least two different ways to develop SNURs.
One approach is to determine for a particular substance with
a known toxicity (or for a category of such substances)
several uses and resulting exposures which would result in
significant risks to health or the environment. A second
approach is to identify for a particular use (taken broadly
to include conventional uses, distribution patterns,
disposal practices) with known exposures, those toxicities
207
-------
which, when combined with such exposures, would present
significant risks. Substances (or categories) then could be
identified as having such toxicities. In either case SNURs
could be developed which would require notice to be
submitted to EPA prior to manufacture or processing for the
uses identified.
EPA may use a variety of criteria as a basis for SNURs,
to signal the need for manufacturers and processors to
submit §5(c)(l)(B) notices. For example, to the extent that
production quantity is a valid surrogate for exposure, the
Agency could use annual production volume in excess of a
certain limit to signal a significant new use. Similarly,
it may be appropriate to use a predetermined level of
exposure as the trigger (e.g., any use which results in a
potential exposure to humans which exceeds (x )ntg/kg/-day
could be considered a significant new use). The basis
underlying a particular SMUR will depend on the
circumstances and information needs of the Agency. However,
as required by §5(a)(2) of the Act, before the Agency
promulgates any SNUR, EPA will consider all relevant
factors, including (1) projected volume of manufacture, (2)
the extent to which a use changes the type or form of
exposure, and (3) the extent to which a use changes the
magnitude or duration of exposure.
208
------- |