US EPA Office of Toxic Substances
PRIORITIES FOR OTS OPERATION. TOO
DAYS REPORT. Jan. 1982

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Priorities for OTS Operation
January 1982
Office of Toxic Substances
nn?5 iCe-0f Pesticides and Toxic Substances
united States Environmental Protection Aqencv
Washington, D.C.

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This document has not been peer and administratively
reviewed within EPA and is for internal Agency use/
distribution only.
0*.
Authorized Sigrv&bure and Date

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NOTE
This document was prepared primarily for internal Office of
Toxic Substances guidance and planning. It presents the Office
Director's current position.

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CONTENTS
I.	Introduction
A.	Purpose
B.	Background
C.	Goals and Objectives
D.	Program Guidance
E.	Organizational Structure
II.	Goals and Objectives
III.	New Chemicals Program
A.	Introduction
B.	Background
C.	Review of PMN's
D.	PMN Rule
E.	Exemptions
F.	Followup
IV.	Existing Chemicals Program
A.	Introduction
B.	Objectives
C.	Improving Communication and Coordination with
Groups Outside OTS
Appendices
IIIA: Followup of New Chemicals
IVA: Defining a Possible Existing Chemicals "Process"

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INTRODUCTION
A.	Purpose
The purpose of this report is to provide guidance to Office
of Toxic Substances {OTS) staff on priorities for OTS programs
over the next few years. This guidance covers both the
management and substance of OTS operations. OTS staff should use
this guidance in their everyday work.. For example, they should
expect that:
(1)	projects will be approved only if they conform to this
guidance and vill be disapproved if they do not;
(2)	performance standards will be based on outputs that
support the goals and objectives given here; and
(3)	their working relationships with other OTS staff must
support the functional requirements of their position
in the proposed organizational structure.
There will be a period of transition from the present to the
intended new form of operation. OTS staff should also use this
guidance to help themselves and the Office as a whole make this
change as smoothly as possible.
B.	Background
This report is the result of 100 days of intense activity
from September through December 1981. The activity was a means
of dealing with a number of problems and concerns identified by
the OTS division directors, several branch chiefs and the new
Office Director. The Director assigned senior staff to examine
OTS goals and objectives, management and organizational issues,
and the new chemicals and existing chemicals programs. They in
turn selected other OTS staff to work with them on their assigned
problems. During and after the 100-day period, the Office
Director reviewed their findings and recommendations. The ones
that were approved are presented in this report.
In each of the assigned areas, the guidance given here will
have associated with it various implementation steps or
activities. OTS will, for example, identify specific outputs
that relate to its goals and objectives; it will develop steps
for moving to and procedures for operating under its new
organizational structure; and it will refine the processes used
in its new chemicals and existing chemicals programs. As this
report demonstrates, these elements are interrelated. The nature
and timing of changes in one area will depend on changes being
made in another. The Office Director will, however, give OTS
staff further guidance in each area as soon as it is possible to
do so. The Office Director may also revise this overall guidance
from time to time as the Office gains experience in implementation
and new information comes to light.

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C.	Goals and Objectives
The first task that any organization must perform is to
define its goals and objectives. The statement presented in
Chapter II provides clear priorities for the Office. It is drawn
from TSCA and from overall EPA guidance. The three goals are:
to provide better guidance for OTS implementation of its new
chemicals and existing chemicals programs, to develop more cost-
effective means for achieving industry compliance with OTS
policies, and to strengthen OTS operations. In Chapter II OTS
gives the reasons why these goals and related objectives are
important. As indicated above, OTS will identify and set
priorities for specific outputs that can be used to measure the
attainment of these goals and objectives.
D.	Program Guidance
The new chemicals program as presented in Chapter III, is
made up of four elements: (i) the review of PMN's, (ii) PMN
requirements, (iii) PMN exemptions, and (iv) followup of new
chemicals. The overall direction of the existing chemicals
program (see Chapter IV) has five parts: (i) focusing on
reduction of unreasonable risks, (ii) emphasizing voluntary
control by industry and the public, (iii) concentrating
evaluation and control efforts on specific problems of chemical
activity, (iv) directing those efforts at problems identified
through specific TSCA mechanisms, and (v) exchanging technical
information with industry, labor groups and others on particular
problems.
In these programs, the limited resources of OTS will be
focused on problems that pose (or are likely to pose) significant
risks to health or the environment. Very minor risks, even if
they could be controlled quickly or at little cost, will not be
addressed. The new chemicals program is intended by TSCA to be a
preventive program. For existing chemicals, in contrast, a
preventive focus would have to be at the expense of ameliorating
present risks. OTS's existing chemicals program, therefore, will
concentrate on solving problems that currently pose a significant
health or environmental risk, rather than on attempting to
identify and prevent problems that might occur in the future.
A simple 50/50 or other split of OTS resources between the
new and existing chemicals programs would belie the more complex
balancing needed to achieve the Office's goals and objectives.
For example, the Administrator's and the Assistant Adminis-
trator's guidance is that activities specifically mandated by
statute or court order should take priority over other activities
that are discretionary in nature. For OTS this means that, while
having an effective PMN process for new chemicals is a very high
priority, the Office will not sacrifice meeting statutory and
court commitments on existing chemicals to conduct detailed.

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1-3
reviews on a few more PMN's. More generally, high priority
existing chemicals projects will not be allowed to slip because
of large PMN workloads.
E. Organizational Structure
At the beginning of the 100-day initiative, the existing OTS
senior staff strongly expressed the opinion that there were
serious problems with the way the Office has been operating over
the past few years. By analyzing these problems it was found
that they could best be resolved by a change in the
organizational structure of the Office. In fact, it became
evident that ensuring effective and efficient operation was the
single most important issue to be faced. As a result, the Office
Director and senior staff spent considerable time in designing
the organizational structure that they thought would prove
best. This structure is a matrix organization. This proposal is
now under consideration by the Administrator. If approved, OTS
will try to implement the necessary reorganization as quickly as
possible so that OTS staff will not be left in limbo long and the
improved management it offers can be instituted soon.
The guidance given in this report represents a commitment by
the Office Director to make consistent decisions and to enable
OTS staff to work productively toward common ends. OTS's future
success depends in large measure on how well this guidance is
followed.

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CHAPTER II — GOALS AND OBJECTIVES
No Office can operate effectively without an overall sense
of mission that can be translated down to more specific guidance
for action. EPA has legislation, the Toxic Substances Control
Act (P.L. 94-469) or TSCA, passed in October 1976, that sets
forth the overall policy for the Office. TSCA states that "It is
the policy of the United States that:
(1)	Adequate data should be developed with respect to
the effect of chemical substances and mixtures on
the health and the environment and that the develop-
ment of such data should be the responsibility of
those who manufacture and those who process such
chemical substances and mixtures;
(2)	Adequate authority should exist to regulate chemical
substances and mixtures which present an unreasonable
risk of injury to health or the environment, and to
take action with respect to chemical substances and
mixtures which are imminent hazards; and
(3)	Authority over chemical substances and mixtures should
be exercised in such a manner as not to impede unduly
or create unnecessary economic barriers to techno-
logical innovation while fulfilling the primary
purpose of this Act to assure that such innovation and
commerce in such chemical substances and mixtures do
not present an unreasonable risk of injury to health
or the environment."
The law authorizes a number of more specific measures that
can be used to implement this policy. It has been the respon-
sibility of EPA, under this law, to develop a program for using
these measures. In order to do so, OTS has identified four main
categories of activity. These are:
(1)	gathering needed information on selected chemicals
that are being or may be manufactured or processed
for commercial purposes in the United States;
(2)	ensuring that industry develops and/or provides
information (e.g., testing results and existing health
and safety data) on how selected chemicals affect or
may affect human health and the environment;
(3)
ensuring that chemicals judged to pose unreasonable
risks to health and the environment are adequately
controlled; and

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(4) subjecting new chemicals to a premanufacture
review before they are allowed into the United
States marketplace.
While these activities sound quite straightforward, the
means for implementing them are, in fact, quite complex. After
five years of operation, EPA is now attempting to bring more
concerted and efficient direction to them. The Office of Toxic
Substances has established three goals for improving its
operation and under each goal a number of objectives. OTS is
already moving ahead to meet these goals and objectives as shown
in the following chapters.
GOAL I; To provide better guidance for OTS implementation of
Its New Chemicals and Existing Chemicals Programs.
Such guidance is essential for improving	the	productivity of the
Office in order to do more with less and	for	telling the public
what to expect. It provides a framework	for even-handed imple-
mentation of the law.
OBJECTIVES;
(1)	To meet all statutory and court-ordered obligations.
The EPA Administrator and the Assistant Administrator for
Pesticides and Toxic Substances both have highlighted this
as a major agency objective. It demonstrates a commitment
to implement TSCA as Congress intended.
(2)	To establish priorities among discretionary TSCA
authorities.
Such priorities are needed to focus those OTS resources
not committed to meeting statutory and court-ordered
obligations on a limited number of activities that will
be accomplished.
(3)	To adequately articulate the reasons and assumptions
for OTS decisions.
Such articulation should increase understanding of OTS's
policies by industry and the public, making voluntary
actions more likely to be consistent with OTS policies.
It should also improve the understanding of those
decisions by OTS staff, thereby increasing the focus of
their effort in the future.

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(4) To improve the scientific basis for OTS decision-
making .
Decision-making under TSCA is generally based on the
scientific concept of risk, as modified by the
judgmental factor of "unreasonableness." OTS1s
program thus is required to have a scientific base, which
must be sound in order to be credible.
GOAL II: To develop more cost-effective means for
achieving industry compliance with OTS policies.
OTS must find ways to ensure that the intent of TSCA is carried
out by the most efficient and least onerous means.
OBJECTIVES;
(1)	To increase voluntary data development and voluntary
safe handling ot chemicals by industry.
In most cases, voluntary action can be implemented faster
and at lower cost to EPA and industry than regulatory
proceedings.
(2)	To use TSCA authority to control industry behavior where
voluntary action is inadequate.
Strong, defensible regulatory action where necessary is
essential to motivate voluntary agreement as well as to
correct the specific problems at which it is directed and
to ensure consistency in toxic chemical control.
(3)	To eliminate any unnecessary burdens on industry of TSCA
actions"	" =
Industry resources for chemical evaluation and control are
limited; they should be devoted to dealing with real
problems, not meeting unnecessary requirements. This will
promote voluntary cooperation when the "burden" is seen
by industry to be necessary and useful.
GOAL III: To strengthen OTS operations.
TSCA implementation is entering its sixth year in a time of
dramatic cuts in Federal programs. OTS must strengthen its
program to remain viable.

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OBJECTIVES:
(1)	To improve OTS's organizational maintenance capabilities.
To be an effective force in the future, as well as today,
OTS must maintain and strengthen its staff's capabilities
and its overall ability to manage its operations.
(2)	To improve OTS relationships with other EPA offices
and agencies.
TSCA actions must be closely coordinated with other offices
and agencies because of potential overlaps of authority.
Better coordination can reduce costs and save time for
OTS by eliminating duplication of efforts.
(3)	To improve OTS relationships with industry, labor and
public interest groups.
These relationships are essential to OTS's statutory infor-
mation gathering and control efforts. Full and frank
exchange of information will promote consistency, clarity
and voluntary cooperation.

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CHAPTER III ~ NEW CHEMICALS PROGRAM
A. Introduction
This chapter describes OTS1s overall approach under TSCA to
new chemicals. In developing this approach, OTS has focused not
simply on premanufacture notice (PMN) requirements; it has also
considered other elements important in a comprehensive new
chemicals program. The program reflects a balancing of the
following elements:
(1)	Review of PMN's. The review of PMN's will be accorded
high priority. Subjecting new chemicals to meaningful
review is essential to ensure that risks associated
with new chemicals are adequately characterized and,
where necessary, controlled.
(2)	PMN requirements. PMN submitters will be required to
provide only the information specified in the Act.
This should be sufficient for review of the vast
majority of PMN's. When more information is needed,
OTS will seek it on a voluntary basis. If the
information is not provided, OTS will issue section
5(e) orders to obtain it. The Office will use section
5(e) flexibly, so that incentives are provided for
industry to characterize risks better.
(3)	Exemptions. By developing exemptions for low risk
chemicalsfrom PMN requirements, OTS will minimize PMN
costs without significantly increasing risks to health
and the environment. Exemptions will also allow EPA to
focus its resources on new chemicals of potential
concern.
(4)	Followup of new chemicals. OTS's followup program will
place a bound on the risks associated with new
chemicals. Judicious use of section 5(a)(2)
significant new use rules supplemented by section 8
information gathering will provide important protection
against risks associated with new chemicals after
commercialization with minimal burdens on industry.
In implementing an effective new chemicals program, OTS will
fully integrate each of these elements into a coordinated overall
approach. Any changes in one element of this approach will be
examined for potential impacts on other elements.

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B. Background
Congress instructed EPA to address risks posed by new
chemicals before commercialization and therefore to protect human
health and the environment from unreasonable risks before damage
occurs. As the TSCA Conference Report states:
The most desirable time to determine health and
environmental effects of a substance, and to take action to
protect against any potential adverse effects, occurs before
commercial production begins. Not only is human and
environmental harm avoided or alleviated, but the cost of
any regulatory action in terms of loss of jobs and capital
investment is minimized. (TSCA Legislative History, p.
678) .
However, the law also requires that the Agency be careful not to
impede innovation and the development of new products
unreasonably.
Congress authorized EPA to review new chemicals in section 5
of the Act, which states that manufacturers must notify EPA at
least ninety days before they make a new chemical. In EPA's
premanufacture review program, which has been in operation since
July 1979, the Agency has reviewed over 1,000 PMN's. This
program has had some good results: A competent scientific staff
has been assembled to review PMN's; methodologies for predicting
potential risks, given limited technical data, have been
developed, although further refinements are needed; and EPA
dealings with industry and other members of the public have been
effective — communications are open and informal rather than
highly bureaucratic. The Agency has generally been able to
persuade manufacturers to adopt voluntary measures to control
exposure when it has identified specific concerns; section 5(e)
orders have been issued only when the voluntary approach has
failed. Most important, EPA has identified and prevented or
reduced risks to health and the environment that might have been
posed by a significant number of new chemicals. Several PMN's
have been withdrawn during the review period as a result of EPA
concerns, and in approximately sixty cases manufacturers have
agreed to develop further data or institute exposure controls at
EPA's suggestion.
In its experience with the PMN program to date, OTS has been
able to make the following observations:
o Relatively few data are submitted on new chemical
substances. This is due, in part, to a perception on
the part of the regulated community that most PMN
chemicals are not intrinsically hazardous. The degree
to which this may be an accurate perception is perhaps
best addressed in considering an exemptions policy.

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III-3
o EPA has had some concern about a number of other new
chemicals and has successfully negotiated voluntary
controls or further data for approximately sixty.
o Only a small number of new chemicals have warranted
formal action. Nine PMN's have been subject to section
5(e) orders, and several others were withdrawn before a
section 5(e) order was prepared. All of these orders
were based primarily on the "may present" rather than
the "substantial exposure" finding. No section 5(f)
orders have been issued.
o Relatively few PMN chemicals have gone into commerce.
(EPA has received Commencement of Manufacture Notices
on only about one third of the chemicals that have
completed PMN review.)
o New chemical substances are produced in relatively low
volumes. Twenty-five percent of PMN chemicals have
projected third-year volumes below 11,000 kg. Only 15
percent have projected third-year volumes in excess of
1,000,000 kg.
o PMN's contain only early projections of a chemical's
eventual production volume and uses; therefore, they
provide limited information concerning the
circumstances that will actually develop once the
chemical is commercialized.
These facts suggest that, despite its successes, the PMN
program as it is now conducted is not completely adjusted to the
realities of commercial chemical development. On the one hand
many new chemicals of low concern may be subject to notice
requirements unnecessarily; on the other hand, new chemicals
potentially of concern but not warranting action early in
commercial development may now enter commerce without any
subsequent EPA review.
To date, OTS has concentrated on developing an effective
process for reviewing PMN's. The Office will continue to refine
this process, both by focusing the initial information
requirements it has proposed for PMN's and by emphasizing
voluntary means and the use of section 5(e) to obtain further
information, where necessary. OTS will also develop rules under
other sections of TSCA to complement the PMN review program and
to establish a comprehensive new chemicals program.
Specifically, it will exempt certain categories of low risk
chemicals under section 5(h)(4)/ and it will develop followup
rules on chemicals of concern under sections 5(a)(2) and 8(a).
In this way, OTS will ensure that Agency resources are focused on
new chemicals of concern, while burdens on industry are
minimized.
The remainder of this chapter describes OTS's overall
approach to new chemicals.

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C„ Review of PMN's
The review of PMN's will continue to be accorded a high
priority within OTS. Although industry has made strides in
protecting health and the environment, a credible PMN program,
subjecting new chemicals to meaningful review, is needed to
ensure that risks associated with these chemicals are adequately
characterized and, where necessary, controlled.
1« Factors of concern in review. OTS has developed several
basic principles in the PMN program for reviewing new chemicals
and allocating resources:
o The PMN review addresses the entire life cycle of new
chemicals (that is, no part of the life cycle of new
chemicals is routinely excluded). Therefore,
occupational exposure; releases to air, water, and
land; and consumer exposure are reviewed to determine
if they raise a potential concern. Congress clearly
intended the PMN review to take this broad approach.
o The review focuses on the new chemical itself_a.s„i.t„
will, be manufactured,..(i_.e. , including reasonably,
anticipated impurities j. ,^The program"pr^i^.sJonJy a
limited evaluation of the "Byproduct's of nanu'f acture**and
processing' and "focuses"to~the"'greatest*"*ex
byproducts of use.	- 			—
o The review focuses on chronic or irreversible
effects. ' Such—ef f ects~may-typicariymanTf est
themselves even at low exposure; in addition, because
there may be a long latency period, such exposures are
often not recognized at the time they occur. Acute
effects are more immediately obvious and more generally
controlled. Nevertheless ,,,acute_effects_are_considered
when potential .toxicity is .severe, particularly if the
expo"se*dJ_Eop,uiation,is not likely to. be aware of ,
potential hazards.
o Both...huma n_ health—and „..env.i ronme ntal„ef f ects-are
addressed in PMN review. _Howev,er,_the. .emphasis of_the
review'' is on" human Health Trl-Sks.- OTS has adopted this"'
approach in part because the re 1 ativeTyJlow production'
volurne and ""re lea s e^l;eyelsr:0f^^^^K^5jL,cal s,_t erid	„to
limit eWvYronmenta 1 concentrations and therefore"
risk. "In""add i't i on ~ elTviVorimFntar assessment
methodologies are not as*^weli~ developed as
methodoiogies~~for —as'se'ss ingnfuniaSniealjEfi-jFi"sJ?s, and the
data base is riot"as extensive. Nevertheless, in spite*"
of these factors,"OTS is continuing to" "develop its
environmentarr; assessment capabi 1 itiesjand wi 1 l_"take"
actfi6n_where_ significant e n v. i. r o rune n t a 1r. i s k s _a r e
identified (such as significant impacts on fish
populations)."		—

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III-5
o Potential risks must_ be assessed at least in part
thro ug sTr a cTur e^ct ivity analyses - - that is,* the
tonicity of new chemical substances is estimated from
their structural similarity to chemicals of known
toxicity. This has,-.be.en_,n,e.c_essary in part because of
the sparsity of test data on the new,„chemi.cal.s
therasjg.1 ves... ..Although. conc.l.u5.ions„,drawn.-on.~the--basis, of
structure-activity analyses must be fcentative, there is
a great deal of evidence to support the us e f_ujness^of'
th'is "approacH""when conducted""by "Trained toxicologis,.ts
and cKemis~€s with broad" expertise.
2. Datg^e^eJLpj3mejn£.,on new chemicals. Congress did not
require testing of new chemicals under section 5." Instead, ITPA
is "given "the""au tHoriTfy~~un~der ' sect'ion~~5Tel"*lior~regui"re;itesti"nq"'"of"'
specific new chemicals when it can make the appropriate
finding. """""—- ~	— ¦¦ -
tlll	ii>m
OTS's experience with the PMN program indicates that
relatively limited health and environmental-effects testing is
performed on new chemicals prior to PMN submission. There are
several reasons for the sparsity of test data in PMN's. First,
many new chemicals do not warrant testing: some belong to
chemical classes the biological activity of which is already well
characterized; others are produced in low volume or used in ways
that lead to limited exposure (e.g., site-limited
intermediates). Second, because new chemicals are early in
commercialization, they often cannot support the costs of
extensive testing. Third, many manufacturers traditionally have
not done testing at this stage in a chemical's development, even
when it was economically feasible. Finally, manufacturers may be
reluctant to create and provide the government with information
because of a fear that the government will act precipitously in
response to positive data.
Limitations in data, however, in some cases limits EPA's
ability to review risks. QTS is structuring the new_chemi.cals,
program sp,.„tha.t_essenti-al—data -can—be—developed_ when needed . .The
Office ,__h.as twojbasic tools for achieving	this end. _ JThe^first is
the* siqnif icant~"new use" and~section .5.(eJ_aathpr,.ities. fEe
judicious use of these authorities canTallow for the tracking of
chemicals of concern so that risks" can be managed over the
commerciaI~Ti"fe"~of'"the"chemical. The. second tool is the*
info.rmation-g.atherTng^gutBorTty'2_qf section 8T~~"As"descri'bed
later, these__authoritris will be used to cons true t^a new
chejtrfcals followup program for chemicals "of "concern that* will
allow EPA to review data at a later stage of commercialization.
In addition to using these formal mechanisms, OTS will
con tin ue t d""work~wrth—i-nd. 1 vi'd uaTPMN~s ubmi't*t e r s "to .encpu r^C„t he,.
d eve lopmentof^needia"data on a voluntary, basis. In the past,
OTS and industry"Have been able to resolve important
uncertainties through such a voluntary approach.

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III-6
Th.e,,.„Qrg.anization for Economic Cooperation and Development
(OECD), a multili^i^iTal™5^^pZri*nc;lmda-ng^febe-M«Hnir:toe:d~SifcaIfces.f«-has
adopted a set "of uniform^guideXiAes. for testing the health and
environmental" 'Iff"'f ects of ch emicals. Wh"ere'""manufactur e'r s .elec t_'to
conduct tests* on ~neW~ch"emicTaIs*", eilfher™"in support of a PMN or
reiporTse to a sect"ioh_5je^)^orrdar,,^TSllenl3our'ag-es^them,**'t:o-*consider "
these^guidelines. Iij^addition, the OECD is considering the
adQgLt!i:QH^df^^M:i^lmui^Pxe]^r.ke'trrDa€a„rMPD)^s"¥t^r'ecommen3'e3 for
new chemicals entering the commercial market? The information
wtl-1x		>al(tl "'|W|B¥w-T-'-'-~'-'—¦« 		L ^ur.11
provTa'e"d""By"~t"Ifis data set is frequently useful in assessing risks
posed by such chemicals and in identifying areas where further
testing should be: conducted. TSCA, however, does not require
across-the-board testing of new chemicals. PMN experience
confirms that rigid testing schemes for these chemicals are
inappropriate —- in some cases, all the MPD data are not
necessary; in other cases, other chemical properties should be
assessed. Therefore, as the OECD recognizes, manufacturers
should use judgment in determining which tests should be
conducted on a specific new chemical. They should base this
decision on such factors as chemical identity, production volume,
intended uses, and likely exposure.
3. Actions under section 5. Although PMN submitters have
generally provided relatively limited health and environmental
effects data, OTS has taken few actions under section 5(e) to
require the development of additional data.* This situation
reflects four facts. First, the limited production volume and
uses of most new chemicals generally lead to low exposure and
consequently low risk. Second, OTS has taken the position that
the section 5(e) "may present" finding must at a minimum be
supported by test data or by a strong structure-activity case
(e.g., that the new chemical is a close analog of substances of
known biological activity). Third, OTS has focused primarily on
the use of section 5(e) to gather test data rather than to gather
other information necessary for a reasoned evaluation of risks
posed by a new chemical. Finally, the Office has not considered
taking section 5(e) action on new chemicals because of
substantial exposure without specific concerns for potential
toxicity.
* Section 5(e) authorizes EPA to regulate a new chemical,
pending the development of information, in the absence of
information sufficient "to permit a reasoned evaluation of the
health and environmental effects" of the substance if it makes
the finding that the substance "may present an unreasonable risk
of injury to health or the environment," or_ that the substance
"is or will be produced in substantial quantities" and "either
enters or may reasonably be anticipated to enter the environment
in substantial quantities or there is or may be significant or
substantial human exposure to the substance."

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III-7
In the future, OTS will use the section 5{e) authority more
flexibly. For example, if the circumstances of early
commercialization limit the risks from a new chemical, but the
standards for section 5(e) actions are otherwise met, the use of
a "delayed trigger" section 5(e) order would allow the chemical
to enter commerce. Data submission would be required later,
either after a certain number of years or after a specified
cumulative production volume had been reached. The decision to
use a delayed-trigger section 5(e) order or an immediately
effective order will depend on the potential risks and the
commercial future of the new chemical. Where the magnitude of
the potential risk and the level of certainty that such risks
will occur is high, OTS will continue to impose immediate
controls. However, where the risks are limited or where there is
less certainty, it is reasonable to allow limited
commercialization and to provide for data submission at a later
time, when the costs associated with testing would be less,
compared with sales volume, and when manufacturers would have
greater certainty of the chemical's commercial potential.
OTS will also use section 5(e) more broadly to obtain
exposure and release information (as well as toxicity test data)
needed to make a reasoned evaluation of new chemicals. Industry
has often suggested that EPA use section 5(e) for this purpose.
Finally, OTS is placing more emphasis on the use of section
5(e) in cases of "substantial exposure" where there is some basis
for concern. The Office has adopted the policy that, where
production volume and exposure are high, section 5(e) will be
invoked if there is significant uncertainty concerning the
effects of a chemical; in this way, OTS will use section 5(e) to
ensure that risks of new high-volume chemicals are adequately
characterized. This approach is especially justified because
high volume chemicals are better able to withstand the greater
costs of characterizing risks.
After reviewing -nearly 1,000 PMN's, .OTS has not yet
seriously considered issuing a section 5(f) order.* The reason
for this is clear; few if any new chemicals are sufficiently
characterized to support a finding that they "will present" an
unreasonable risk. It is much easier to make the "may present"
or "substantial exposure" finding of section 5(e). Therefore,
the section 5(e) authority can be more readily used to control
risks from new chemicals. Also, where risks are so evident as to
warrant action under section 5(f), they will typically be
identified by the manufacturer. In this case, the risks will be
* If EPA finds "that there is a reasonable basis to conclude"
that a new chemical substance presents or will present an
unreasonable risk of injury to health or the environment before a
rule promulgated under section 6 can protect against such risk,"
the Agency can regulate the substance under Section 5(f).

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III-8
adequately controlled or no notice will be submitted. For these
reasons, it appears that section 5(f) is a practical regulatory
tool only in special circumstances. In the event that a section
5(f) issue arises, it would be handled on an ad hoc basis.
4. Relative risk ("me-too" issue). Many new chemical
substances present risks comparable to risks presented by
structurally similar existing chemicals. In reviewing new
chemicals, OTS considers these comparative risks. For example,
when a new chemical of concern would-substitute for a chemical of
greater concern, the Office has generally declined to take action
on the theory that it should not do anything to discourage
substitutions that would lead to a significant reduction in
risk. It has also been argued that EPA should not take action
against a new chemical if existing substitutes present comparable
risks. OTS has generally rejected this approach: It is Office
policy that the Agency should not refrain from regulatory action
against a new chemical simply because risks posed by the new
chemical were likely to be comparable to risks from similar
chemicals already on the market. Thus, OTS has rejected the "me-
too" approach to new chemical regulation.
The rationale for OTS's approach is two-fold: (1) Congress
intended that EPA subject new chemicals to a higher standard than
existing chemicals, and (2) OTS should discourage innovation in
classes of chemicals of known concern without the development of
adequate data. This policy must be applied flexibly. In
circumstances where chemicals provide significant benefits, EPA
should not take action in cases of comparable risk. In general,
however, the rejection of the "me-too" principle is essential for
a viable new chemicals program. Most potential actions under
section 5 will raise questions of comparable risk because new
chemicals are typically modifications of existing substances. If
actions were not taken in such circumstances, EPA's authority
under section 5 would be seriously compromised. This would
clearly contradict Congress's intent that EPA treat new and
existing chemicals differently.
D. PMN Rule
The major purpose of a PMN rule would be to tell the public
what information must be submitted as part of a premanufacture
notice. The proposed PMN rule and forms, which appeared in the
Federal Register of January 10 and October 16, 1979, are
controversial. Industry generally views the rule as overly
burdensome and argues that submitters would be required to go
through the expense of providing information that is generally
not needed to review PMN's. In addition, many commenters argued
that EPA overreached its authority in interpreting the Act's
requirements. On the other hand, some environmental and labor
groups have stated that the proposed rule would not provide EPA
with enough information to perform an adequate review.

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III-9
It is clear that the form reproposed on October 16 is
imposing, even though it is considerably simpler than the January
10 form. OTS has also learned, after two and a half years of
experience with reviewing PMN1s, that much of the information
required in the latest proposal is not, in fact, needed for the
review of most notices. Therefore, OTS now believes that the
information requirements should be further focused and that
submitters should be required to provide only the minimum
specified in section 5(d)(1) of the Act, which references the
information required in section 8(a)(2)(A-G) except (E):
(A)	The common trade name, chemical identity, and molecular
structure
(B)	The proposed categories of use
(C)	Estimates of the total amount of the substance to be
manufactured and of the amount to be manufactured for
each proposed category of use
(D)	A description of byproducts of manufacture, processing,
use, and disposal of the substance
(F)	Estimates of the number of individuals who will be
exposed in their places of employment, and the duration
of such exposure
(G)	The manner and method of disposal.
Given this general list of information requirements, two
specific questions remain: (1) How should these information
requirements be interpreted? (In other words, what information,
specifically, should submitters be required to provide?) and (2)
Should EPA publish a mandatory form, which submitters would be
required to use?
1. Information requirements. As with most statutory
provisions^ the information requirements listed in section
5(d)(1) are subject to different interpretations. The proposed
PMN rule represents an expansive interpretation. OTS is now
adopting a narrower interpretation. Information that is clearly
specified in section 8(a)(2)(A-G) except (E) must be required.
In addition, information that is essential for the review of most
PMN's and that reasonably falls within the intent of section
5(d)(1) will also be required. Other information would be
optional.
OTS will still have means at its disposal to gather
information for the minority of PMN chemicals on which further
information is required to make a reasoned evaluation. Informal
requests to the PMN submitter have generally in the past proved
adequate to secure needed information; OTS will rely increasingly
on this mechanism. Nevertheless, there may still be

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circumstances under which a submitter refuses essential
information. If this occurs, OTS will issue a section 5(e) order
if the necessary findings can be made.
2. Mandatory form. OTS intends to require PMN submitters
to complete a simplified form. The form will be easy to fill out
so that burdens on the submitter are minimized. It will
establish a uniform standard providing submitters a clear idea of
what is expected of them; it should make it easier to familiarize
submitters with PMN data requirements. In addition, the form
would facilitate OTS review of PMN's and the computerization of
the information submitted in the notices.
E. Exemptions
As previously stated, many new chemicals present little risk
and do not warrant full-scale PMN review early in
commercialization. Requiring a PMN on these chemicals imposes a
burden with relatively few if any health or environmental
benefits. A carefully designed exemption policy under section
5(h)(4) will eliminate much of this burden without significantly
increasing risk to human health or the environment.
A section 5(h)(4) exemption, to be usable, must be
structured so that it exempts categories of chemicals. OTS
experience in its section 4 test program and elsewhere indicates
that it is a difficult and controversial task to make findings on
categories of chemical substances. Defining classes of chemicals
that "will not present an unreasonable risk" may be equally
difficult. However, OTS does not expect to achieve a fail-safe
system; its goal instead is to develop exemptions that will
provide reasonable assurances that exempted chemicals will not
present such a risk.
In a recent petition, the Chemical Manufacturers Association
(CMA) identified polymers, site-limited intermediates, and low-
volume chemicals as candidates for a section 5(h)(4) exemption.
The CMA approach follows two general lines of reasoning. First,
polymers represent a class of substances that have intrinsically
low levels of biological activity. Thus, the finding of no
unreasonable risk could in this case be made primarily on the
basis of inherent toxicological properties; the finding would not
depend on conditions of use. As a result, it would not be
necessary for EPA to review the specific properties or uses of
exempt polymers before they were manufactured. On the other
hand, low-volume chemicals and site-limited intermediates are not
intrinsically limited in potential toxicity; instead, they are
characterized by limited exposure. For this reason, CMA has
suggested that chemicals in these classes be eligible for
exemption only after a "qualified expert" employed by the
manufacturer establishes that the chemical is not hazardous under
the conditions of use. In addition, the exemption would provide
for an abbreviated OTS review, based on the submission of minimal
data.

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III-ll
Review by an industry "qualified expert" may compensate for
the absence of toxicity restrictions for these exempt
chemicals. However, an acceptable definition of "qualified
expert" and standards for a minimal risk assessment will be very
difficult to develop. VJhile OTS is making progress in this area,
a qualified expert provision is unlikely, by itself, to ensure
that no unreasonable risk may occur. Therefore, it is essential
that EPA subject each exempt site-limited intermediate and low-
volume chemical to an abbreviated review, perhaps before
manufacture begins under the exemption.
An important issue to be resolved is the amount of
information that would be required in an exemption notice. If
exemption notices are burdensome, exemptions will not be used;
however, OTS will need enough information to be reasonably sure
that a chemical is eligible for the exemption. OTS is
considering this fact in defining its information needs.
As a necessary part of the abbreviated review, EPA should
have the authority to declare a chemical ineligible for the
exemption if it determines that the chemical may present an
unreasonable risk. Although industry has expressed concerns that
such authority will add considerable uncertainty to the exemption
process, manufacturers will in fact have a high degree of
certainty that EPA will rarely declare a chemical ineligible.
This is because (a) the exemption already defines a low-risk
category, (b) the qualified expert will have assessed the
chemical and certified that it is eligible for the exemption, and
(c) the "may present" standard will ensure that only chemicals of
real concern are excluded. CMA originally suggested a very
different approach? under the terms of the CMA petition, EPA
would be able to act against an exempt chemical only if it could
demonstrate an imminent hazard under section 7. Because OTS has
not yet seen a new chemical that met the standards for a section
5(f) order, it seems implausible that a new chemical to be
manufactured under the terms of the exemption would meet the
criteria for action under section 7.
CMA has suggested and OTS believes that it is important that
exempt chemicals not be placed on the TSCA Inventory. This will
go a long way toward solving a major problem with the PMN program
as it now operates. Under the current system, EPA receives
notices on many new chemicals whose toxicity is sufficiently
characterized for their proposed conditions of manufacture and
use (e.g., many site-limited intermediates and low-volume
chemicals). However, the toxicity of these chemicals may not be
sufficiently characterized for uses that involve more exposure.
Under the current program, these chemicals are added to the
Inventory after commercial production begins. At this point,
they may be produced in any. volume and for any uses without
restriction or prior EPA review. If, on the other hand, these
chemicals were exempt from PMN notice for low-exposure uses and
were not added to the Inventory, they would be subject to
notification before manufacture for nonexempt uses. In this way,

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111-12
EPA would receive a PMN at a point in the chemical's commercial
development when it could expect risks associated with the new
chemical to be characterized more fully.
F. Followup*
EPA's review of chemicals at the premanufacture stage must
focus on the intended methods of manufacture and use described in
the PMN, and it is based on toxicity data that the manufacturer
has developed before commercialization. After a new chemical is
entered on the Inventory, however, unrestricted commercialization
is possible (in the absence of a significant new use rule)
without further data development or EPA review. Thus the PMN
review addresses an extremely narrow segment of the risks that
may eventually be posed by new chemicals. For this reason, a
credible followup program is an essential element of the new
chemicals review program.
Followup will be based on several principles derived from
OTS experience in the PMN review program. These principles are
described below.
o Most new chemicals will not be subject to followup
rules. Followup will be focused instead on chemicals
of concern and substances for which there is
significant uncertainty concerning toxic effects.
(This is particularly true for followup under
significant new use rules.)
o Most new chemicals do not become established in the
marketplace and few grow to significant production
volume (indeed, the production volume of a high
percentage of existing Inventory chemicals is below
50,0 00 kg a year). Therefore, EPA will complement the
PMN review by later review of certain chemicals that
achieve commercial success.
o Because of the cost of testing and limited exposure
early in commercial development, extensive testing may
be more appropriate later in a chemical's commercial
development. If EPA does not follow up new chemicals
of concern, data necessary to characterize risks posed
by these chemicals later in their commercial develop-
ment in many cases may not be developed.
The followup of new chemicals will rest primarily on
sections 5(a)(2) and 8(a). The following sections explain how
these authorities will be used.
* The appendix to this chapter explains in more detail OTS•s
program for followup of new chemicals.

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II1-13
1.	Significant new use rules. OTS will issue SNUR's on new
chemicals where it has significant concern about possible new
uses of a chemical or class of chemicals, where it believes those
uses reasonably may occur, and where review under section 5 is
necessary to protect health and the environment against
unreasonable risk before it occurs. Examples of a new use might
be: (a) reaching a designated production volume, (b) a new
consumer exposure, and (c) uses inconsistent with controls
required in a section 5(e) order that does not ban production of
a new chemical.
2.	Section 8(a) information-gathering authority. OTS will
also implement the section 8(a) authority to gather information
on selected new chemicals after they have entered commercial
development. This will allow OTS to identify risks posed by new
chemicals of concern after they have entered commercial
production but early in their commercial development. Formal
action in response to information received under section 8(a)
must be taken under other authorities of the act (e.g., sections
5(a)(2), 4 and 6). OTS's priorities for action on chemicals
under these authorities will be independent of its priorities for
action on fully commercialized chemicals on the Initial
Inventory.
To achieve these ends, OTS will issue chemical-specific,
volume-triggered section 8(a) reporting rules on new chemicals of
significant concern. The Office has rejected a generic approach
to section 8(a) followup of new chemicals. It will require
followup reporting only where it has identified specific
concerns.
Section 8(a) followup rules will focus on gathering
information on production volume and use and will be structured
so as to impose a minimum reporting burden on submitters. The
information reported under this rule will allow OTS to target its
resources on recently commercialized chemicals of concern. Since
information requirements will be limited, the burden of the rule
will not be great. When information is provided, OTS will be in
a position to decide whether action is appropriate, such as the
encouragement of voluntary testing, requirement of testing under
section 4, issuance of a SNUR, referral of the information to
another agency for possible action, or regulation of the
chemical.

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CHAPTER IV -- EXISTING CHEMICALS PROGRAM
A.	Introduction
The focus of efforts on existing chemicals during the 100-
day initiative was to identify and resolve the primary problems
that have led to a sense that the OTS existing chemicals program
is misdirected and accomplishing little. OTS identified problems
in the following areas;
1.	Inadequately defined objectives for the existing
chemicals program efforts.
2.	Inadequate communication and coordination of efforts
with other offices and agencies, industry, and other
outside groups.
3.	No approved "process" for conducting existing chemicals
evaluation and control efforts.
4.	Inadequate management to achieve existing chemicals
program objectives.
The first two problem areas were addressed in the existing
chemicals study whose conclusions are presented in the following
sections. The third is addressed through the design of a
possible existing chemicals process for OTS that is described in
an appendix to this chapter. The fourth problem area is being
addressed through a broader reassessment and restructuring of the
OTS organizational structure.
B.	Objectives
The existing chemicals efforts of OTS generally lack the
action-forcing characteristics of the PMN process -- a need to
make decisions on specified chemicals within a fixed time
period. As a result, OTS's existing chemicals efforts require a-
clear focusing by management if they are to be effective. One of
the primary projects of the 100-day activity has been to define
such a management focus to guide OTS existing chemicals
efforts. That focus, which draws upon and applies OTS goals to
existing chemicals, is presented in this section. Its
fundamental directions (and redirections) are:
(1)	OTS's primary mission is to bring about reduction of
unreasonable existing health and environmental risks to
levels where the residual risk is not unreasonable.
(2)	OTS's preferred method for achieving such risk
reduction is through encouraging voluntary control
measures by industry and the public. OTS will

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IV-2
reserve regulatory controls for those instances where
conflicting market forces and other factors make
voluntary control infeasible.
(3)	OTS will redirect its existing chemicals efforts from
past attempts to develop comprehensive analyses of all
effects and exposures of selected chemicals to focusing
on evaluating and achieving any necessary control of
specific problems that may be posed by a given activity
with the chemical.
(4)	OTS will give primary attention to evaluating and
controlling existing chemicals problems identified
through specific TSCA mechanisms, such as section 8(e)
"substantial risk" notices, chemicals found to produce
adverse effects in testing performed in response to
recommendations of the Interagency Testing Committee,
and petitions received under section 21. The ITC will
also be involved in priority testing of 8(e) chemicals
where the data do not support regulation due to lack of
data.
(5)	Because much of the information on hazards and
exposures of existing chemicals is fragmented, OTS will
actively seek exchange of technical information with
industry, labor groups, and others early in and
throughout its evaluation and decision processes.
However, OTS information requests will be focused on
particular problems it is concerned about -- OTS will
not engage in broad-scale "fishing expeditions" to
gather data where it has no specific evidence of a
possible problem.
Discussed below in more detail are the principal issues OTS
identified for managing its existing chemicals program.
Issue 1 — Relative Priorities of Various Types of Existing
Chemicals Activities'
What should be the relative priorities in the OTS Existing
Chemicals Program among the following types of activities:
a.	Information collection and generation on selected
chemicals or classes of chemicals aimed at providing a
general data base usable by OTS, other offices and
agencies, and the private sector in problem
identification, problem evaluation, and possibly control
efforts (Toxics Data Base Development);
b.	Information collection and generation to support
specific problem evaluation and control efforts of other
offices or agencies on chemicals or problems

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IV-3
they have identified (Information Gathering Support on
Specific Problems Identified by Others);
c.	OTS problem identification efforts (and the necessary
supporting information collection and generation
efforts) focused on identifying serious health or
environmental problems irrespective of the organization
or statutory authority most likely to be used to correct
them (Broadly Focused Problem Identification);
d.	OTS problem identification efforts (and the necessary
supporting information collection and generation
efforts) focused on identifying unreasonable risks
likely to warrant TSCA control efforts (Identification
of TSCA Control Problems);
e.	Encouraging reduction in risks to health and the
environment through coordinating control efforts
conducted by other offices and agencies (Coordinate Non-
TSCA Control Efforts);
f.	Encouraging reduction in risks to health and the
environment through direct OTS efforts to encourage
industry and/or the public to handle chemicals in ways
that eliminate unreasonable risk (Work with Industry and
Public to Reduce Risk Voluntarily); and
g.	Using TSCA control authorities to eliminate unreasonable
risk where government regulation is necessary and TSCA
provides the most appropriate statutory authority
(Regulate Under TSCA to Control Risk)?
Although all of these types of activites could be
pursued in a comprehensive OTS existing chemicals program, two
factors will limit efforts in the seven areas identified. First,
at any given time there may not be suitable projects to carry out
in all of these areas. Second, limited resources will require
choices among the projects that could otherwise be carried out.
The following is the order of relative priority OTS will follow
in selecting among existing chemicals projects not specifically
mandated by statute, court order, or existing EPA regulations,
assuming viable projects are available in all categories.
Priority
Rank	Activity
I	(f)	Work with Industry and the
Public to Reduce Risk
Voluntarily

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IV-4
2
(g)
Regulate Under TSCA to Control
Risk
3
(e)
Coordinate Non-TSCA Control
Efforts
4
(d)
Identification of TSCA Control
Problems
5
(b)
Information Gathering Support on
Specific Problems Identified by
Others
6
(c)
Broadly Focused Problem
Identification
7
(a)
Toxics Data Base Development
The reasons for this ranking are as follows: First,
reducing significant health and environmental risks should be the
primary existing chemicals goal. This can be achieved through
activities (e), (f), and (g). Among them, direct interaction of
OTS with industry and the public in efforts to achieve voluntary
risk reduction is likely to have the greatest payoff in reduced
risk for a given amount of OTS resources. However/ where
regulation under TSCA is truly needed to control a significant
risk, OTS will devote the effort necessary to develop sound
regulations that do not impose unnecessary burdens. Achieving
risk reduction indirectly, through coordinating control efforts
of other EPA offices or other agencies, is another means of
accomplishing the goal of reducing significant risk and OTS will
try to assume that role in those instances where it is the most
knowledgeable or otherwise the group best suited to do so.
However, this is not OTS's primary approach to accomplishing its
risk reduction goals.
Before taking actions aimed at reducing risk, OTS must
identify and evaluate potential risk problems. TSCA problem
identification efforts (d) are ranked next below the control
efforts. This does not mean that OTS will spend all of its
existing chemicals resources on control efforts and none on
problem identification or data gathering, since it must have
problem identification and evaluation efforts to set and order
its control efforts agenda. However, the problem identification
efforts will be subordinate to the control efforts rather than
being seen as the primary mission. Among these efforts, OTS will
give greatest priority to efforts more likely to identify
problems appropriate for OTS control. Although at the earliest
stages of problem identification a relatively broad focus may be
necessary, OTS's goal is to narrow in on TSCA problems as quickly
as possible. Where potential risks are identified that are not
clearly the exclusive jurisdiction of a single non-OTS office or

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IV-5
agency, OTS will, as resources permit, pursue their definition to
the point where the appropriate role of OTS in further evaluating
and/or controlling them can be determined.
The two data gathering activities, (a) and (b), and
broadly focused problem identification (c) are ranked
lower because the primary focus of OTS efforts will be on TSCA
implementation. TSCA does provide information gathering tools
that can provide valuable data for other offices and agencies.
OTS will take a more aggressive effort to "sell" its information
capabilities to others, especially other EPA offices. OTS can
make valuable contributions to the programs of those groups at
relatively low costs to OTS by combining the needs of others with
OTS's in joint information collection efforts. Nevertheless,
while OTS should increase its effort in that area, it is not the
primary mission OTS will pursue. In supporting the information
needs of others, OTS will emphasize meeting their specific
current needs, rather than broadly focused problem identification
or trying to build general data bases that are likely to require
substantial OTS and industry resources to maintain for possible
future utility.
This general priority ranking is just that. Specific output
commitments identified in annual operating plans will have to
take into account other factors, especially the availability and
case-by-case importance of specific projects in each area.
Issue 2 — Priorities Among Different Types of Hazards
What types of risks should OTS concentrate on (acute vs. chronic
hazards, environmental \rs^ human)?
The emphasis of the OTS existing chemicals program will be
to correct the most serious health and environmental problems.
This means that priority decisions must consider the extent of
exposure (and, thereby, risk) as well as the type of hazard
involved. Nevertheless, some types of hazards should (given
comparable exposure situations) receive priority. Among human
health effects, OTS will give priority to life shortening and
chronically debilitating types of effects, as contrasted with
reversible injuries. By statute (sections 4(e) and 4(f)),
particular priority is to be given to cancer, gene mutations, and
birth defects. Among environmental effects, OTS will give its
greatest emphasis to problems likely to result in serious food or
other economic losses.
Issue 3 — Focus and Priority of OTS Problem Identification
Efforts
Should the OTS Existing Chemicals Process include the
initiation of information gathering and reviews to identify
potential problems or should it respond only to information
submitted through statutory mechanisms (section 8(e) notices, ITC
list, section 21 petitions, etc.)?

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IV-6
For example, should OTS:
o Gather and review information on selected industry sectors
associated with developing scarcities in natural resources
or emerging technologies?
o Seek out new effects and environmental occurrence data
and/or use predictive tools to try to identify chemicals
that might pose significant health or environmental
problems?
o Attempt to systematically sort through and evaluate
chemicals on the TSCA Inventory not currently identified
as potentially posing risks?
OTS will focus its existing chemicals efforts on responding
to significant health and environmental problems. The first
priority in doing so will be dealing with those problems brought
to the attention of OTS through TSCA statutory mechanisms
(section 8(e) notices, section 21 petitions, etc.). OTS efforts
to identify potential problems not brought to its attention
through statutory mechanisms will be of lower priority and their
extent will be decided on a year-by-year basis in the approval of
the OTS Operating Plan. To the extent resources are available
for OTS-initiated problem identification, they will be focused on
investigating chemicals or industry sectors where there is good
reason to anticipate that significant risks may occur. General
screening of high production volume chemicals or of various
industry or use categories "to be sure there are no problems
there" is not a good use of OTS's limited resources.
Issue 4 — Comprehensive vs. Problem-Oriented Focus
Should OTS focus its efforts on solving discrete "problems"
involving a chemical or should it try to produce a
"comprehensive" assessment of each chemical it deals with?
OTS will adopt a "problem-oriented" focus rather than one
that attempts to produce a comprehensive evaluation of all
aspects of a given chemical, industry or other subject. For
example, a properly constituted citizen's petition for adoption
of a section 6 rule should specify the nature of the risk to be
controlled, including specification of the activity proposed to
be regulated, the substance(s) involved, the nature of the
adverse effect(s) expected and the population group(s) at risk.
Once such a "problem" has been defined, OTS's primary focus will
be on evaluating it and determining whether or not action is
warranted, not on investigating other possible effects of the
substance, other unrelated risks to the population group, or
other activities involving the substance that also may give rise
to significant risks. The last type of activity is appropriate
in the context of OTS problem identification efforts that might
be triggered by such a petition, but OTS's response to the
"problem" posed by the petition will not be delayed while OTS

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IV-7
seeks to identify additional problems. OTS's own problem
identification efforts will be focused on narrowing down the
scope of attention as quickly as possible so the Office can
concentrate on reaching a conclusion on a few specific
problems. While this problem-oriented approach increases the
chances that OTS may "miss" a significant problem from time to
time, OTS will be more effective overall by narrowing its focus
and reaching conclusions than by attempting to study all aspects
of a chemical simultaneously.
Issue 5 — Definition of Unreasonable Risk
Does "unreasonable risk" under section 6 exist when the damage to
health or the environment exceeds the costs to society in
reducing the risks?
OTS will interpret "unreasonable risk" under TSCA to mean a
situation in which a judgment is made that the probability and
magnitude of harm to society of the use of a chemical are likely
to outweigh the benefits. The benefits will be determined by the
uses to which the chemical is put--e.g., by itself or as an
intermediate in the production of a compound or material that has
valuable applications, as well as by the profits and employment
due to its sales. The risks will depend on the certainty that
the chemical poses a risk, the nature of the hazard (death or a
temporary effect; occurrence after long-term, continued exposure
or limited, high exposure; etc.), and the impact (i.e., the
probability of risk to a given individual, the number of people
exposed, the geographical distribution of the people exposed,
etc.). OTS realizes that no formula can be used to determine
unreasonable risk, since the amount and nature of the information
will differ in each case. It will apply the general approach to
benefit-risk analysis described here on a case-by-case basis.
This is the type of analysis required of EPA by section 6(c)(1)
of TSCA.
Issue 6 — Establishing Criteria for Choosing Between
Voluntary and Regulatory Approaches"
Should OTS establish criteria for deciding when to encourage
industry to adopt controls voluntarily and when rulemaking under
section 6 should be initiated?
OTS will not attempt at this time to establish guidelines or
criteria for deciding when to cease voluntary control efforts and
initiate rulemaking under TSCA section 6. In all cases, OTS will
explore voluntary alternatives before deciding that rulemaking is
required (except where rulemaking is required by statute, as for
PCB's). The decision to move from a voluntary to a regulatory
mode will be made on a case-by-case basis, taking into account
all of the relevant factors in the particular case.

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IV-8
Issue 7 — Relative Priorities of Activities on Specific Types
of Problems
What should be the relative priorities in the OTS existing
chemicals program of efforts on section 21 petitions, section
8(e) chemicals, ITC chemicals, etc.?
This issue is addressed in two parts, separately considering
priorities among problem identification efforts on the one hand
and among evaluation and control of specific problems on the
other. As indicated in the discussion of Issue 1, control
efforts will generally be considered to be of higher priority
than problem identification efforts, although a balanced program
requires some of the latter.
a. Problem Identification Efforts
OTS will employ the following priorities in planning and
carrying out its efforts to identify and define problems that
warrant additional OTS evaluation and, possibly, control:
Priority
Rank	Activity
1	o Evaluating ITC chemicals after test data are
received to determine what potential problems,
if any, warrant further OTS assessment.
2	o Gathering and evaluating release/exposure infor-
mation on ITC chemicals before their testing
is completed to identify and characterize
potential problems that might warrant OTS
follow-up if "positive" test data are obtained.
3	o Preliminary evaluation of section 8(e) "sub-
stantial risk" notices to define and
characterize any specific "problems" identified
by the submitter.
4	o Gathering and evaluating exposure information
to identify and characterize potential problems
that might be caused by chemicals reported in
scientific journals, section 8(e) notices,
or "FYI" notices as capable of causing adverse
health and environmental effects.
5	o Gathering and evaluating information to define
and characterize potential problems, other
than the specific problem(s) identified by the
submitter, that may be caused by a chemical
subject to a section 21 petition for control
of an existing chemical.

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IV-9
6	o Problem evaluation of NTP and	CUT test results,
FYI notices from industry and	other information
from outside groups to define	and characterize
any existing problems.
7	o Gathering and evaluating information to
characterize potential existing chemical
problems identified through PMN reviews (e.g.,
ZDDP's and cutting fluids).
OTS considers ITC chemicals its highest priority source of
potential problems among existing chemicals. In descending order
of priority, other sources OTS will use (as resources permit) are
section 8(e) notices, section 21 petitions, groups outside OTS,
and PMN reviews. Tor each source, OTS will gather and evaluate
exposure and other relevant information to identify and
characterize the potential problems.
b. Problem Evaluation and Control
OTS priorities for evaluation and control of existing
chemical problems are as follows:
Priority
Rank	Activity
1	o Controlling problems believed to pose an imminent
hazard.
2	o Controlling problems for which the Administrator
has found section 4{f) applicable.
3	o Meeting court order on PCB remand.
4	o Evaluating problems identified by OTS as
potentially subject to section 4(f) to determine
4(f) applicability.
5	o Evaluating problems identified in section 21
petitions to determine whether the petition should
be granted or denied.
6	o Evaluating and responding to requests for
exemptions under TSCA control regulations.
7	o Controlling problems identified and evaluated
under TSCA (e.g., ITC chemicals, section 8(e)
notices and section 21 petitions).
8	o Controlling problems on which other offices/
agencies have requested TSCA control.
9	o Evaluating the need for OTS control efforts
on problems identified in Section 8(e) notices.

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IV-10
10	o Evaluating the need for OTS control efforts on
ITC chemicals following their testing.
o Evaluating the need for OTS control efforts on
non-ITC chemicals whose testing OTS has
encouraged or required.
o Evaluating the need for OTS control efforts on
existing chemical problems associated with PMN
actions (e.g., ZDDP's).
12	o Evaluating the need for OTS control efforts on
other existing chemical problems identified by
OTS.
With one exception, controlling a problem OTS truly believes
to pose an "imminent hazard," OTS's highest priorities for
existing chemicals evaluation and control are activities with
specific statutory or court-ordered time constraints. These
activities are meeting EPA's statutory obligations under section
4(f) of TSCA to act within 180 days on any problem that the
Administrator has determined to be covered by that section,
meeting the court order on PCB's, performing the analysis needed
to determine if section 4(f) applied to a problem, and responding
to section 21 petitions within the statutory 90-day period. Next
in priority below meeting its statutory and court obligations,
OTS will process exemption requests under already-promulgated
TSCA regulations. Once OTS adopts a rule, OTS has an obligation
to promptly process such requests if the rule allows for them.
In controlling problems where OTS does not have specific
statutory deadlines, the Office will give greater priority to
problems identified and evaluated under TSCA than to problems
where TSCA control is requested by other offices or agencies.
OTS has primary responsibility for implementing TSCA and is
likely to be more knowledgeable of and more efficient in dealing
with the former type of problems than the latter. Nevertheless,
OTS will make every effort to take on serious problems referred
to it by other offices and agencies since OTS will be similarly
trying to "hand-off" problems to them.
The Office's problem evaluation efforts are, of course,
essential for supporting its control efforts. Problem evaluation
efforts are ranked below control efforts (except for section 4(f)
cases and section 21 petitions, where there are statutory
deadlines) to indicate that should the OTS find itself with an
overload of control problems at some time, it will focus on
concluding the backlog of control problems rather than doing
evaluation to develop a still larger backlog. This has not been
a problem for OTS to date. Problems identified through TSCA
mechanisms (section 8(e), section 4, etc.) will receive greater
priority for evaluation.

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IV-11
C. Improving Communication and Coordination with Groups
Outside OTS
OTS examined several issues related to how it interacts with
outside groups (other offices and agencies, industry, labor and
environmental groups, etc.) during the 100-day project. The
conclusions that were reached are presented in this section.
Issue 1 — How Can OTS Obtain Adequate Access to Inform-
ation Held by Other Government Groups?
In the past, OTS has pursued various mechanisms to obtain
access to information held by other EPA offices or other Federal
agencies that would be relevant to OTS investigations of existing
chemicals problems. In some instances, informal staff-level
contacts have been relied upon, while in others more formal
management-level requests have been made for information. In a
few instances, broad memoranda of understanding (MOU's) have been
developed with other agencies to provide a framework for
information exchange and joint efforts. Despite these efforts,
OTS often is not sure it is aware of relevant information that
other government groups may hold.
OTS's primary effort to solve this problem is reflected in
the proposed OTS organization, which would create a focal point
of contact and responsibility for such coordination. This would
help establish OTS's standing as a toxic chemicals information
source for EPA and other agencies. Specific approaches to
developing better information exchange with other government
groups will be developed by as part of the OTS Operating Plan.
In general, however, OTS will concentrate on developing action-
oriented mechanisms to gather information needed for specific
high priority OTS projects, rather than expending resources in
developing broad, non-specific MOU's.
Issue 2 — How can OTS Achieve More Effective Information
Exchange with Industry on Existing Chemicals'
Problems?
In the past, OTS's interactions with industry to
exchange information relevant to ongoing existing chemical
evaluations often have been characterized by extensive contact by
EPA contractors seeking information and generally infrequent
contacts by OTS staff who would be in a position to discuss the
Office's current perspective on the chemical or problem and to
indicate what information OTS has and what additional information
it is likely to need. Only as a chemical progressed to a fairly
detailed stage of analysis has substantial direct exchange of
information between OTS and industry taken place. There have
been some notable exceptions to this rule (e.g., evaluation of
ITC testing recommendations and certain section 8(e) notice
evaluations) but, in general, interaction with industry in
evaluating existing chemicals has been much less than for new

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IV-12
chemicals. In part, this may be a result of PMN's typically
having an identified, single source of information, the PMN
submitter, while multiple and sometimes unknown companies possess
the desired information on an existing chemical problem.
To improve its information exchange activities with industry
OTS will do the following:
(1)	OTS will initiate a formal dialogue with industry
earlier in its existing chemicals evaluation process.
As a matter of course, OTS will initiate information
exchange with industry on each problem that is selected
for the detailed evaluation. This exchange will be
initiated by OTS staff, employing contacts identified
with the help of the Industry Assistance Office, rather
than by OTS contractors. OTS may initiate informal
information requests to industry at earlier stages in
the existing chemicals process where necessary to
resolve major uncertainties.
(2)	To minimize duplicative information requests to
industry, all contractor information gathering contacts
with industry will be approved by the contract Task
Officer or Project Officer before being made. The Task
Officer or Project Officer will be responsible for
ensuring that such requests are necessary. In the
Detailed Evaluation Stage and later stages of the
existing chemicals process, the project manager
responsible for the problem will ensure coodination of
all information requests to industry.
(3)	Before soliciting information from industry, OTS will
consult OTS files, search readily accessible data bases,
and contact other offices or agencies known or strongly
suspected to have the desired data. This will be done
to avoid unnecessary requests to industry but should not
discourage early contact with industry to obtain
information otherwise unavailable to OTS.
(4)	Generally, OTS will pursue voluntary submission by
industry of needed information before using TSCA
reporting requirements. However, in those instances
where statutory or court deadlines would be compromised
by first seeking data voluntarily or if there is a
substantial reason to believe that a TSCA reporting
requirement would be more cost-effective than a
voluntary approach, OTS may initiate a reporting
requirement at the outset. Industry comment on the
Advance Notice of Proposed Rulemaking and/or proposed
rule will provide a basis for evaluating whether
voluntary means can suffice.

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IV-13
Issue 3 — How Should OTS Make Its Information Available
to Outside Requestors?
The Freedom of Information Act (FOIA) imposes a legal
obligation to provide non-exempt information to outside
requestors, although reasonable charges may be imposed to reflect
the costs of file searches and duplication. If OTS is successful
in increasing its stature as a primary Federal source of
information on toxic substances, outside requests will increase,
both from the public and other agencies. In view of increasingly
tight budgets, OTS will exlore the feasibility of various user
charges that would directly support OTS's information staff.
Issue 4 — What Existing Chemicals Problems Should OTS
Address and Which Should be Handled by Other
Groups?
A perennially recurring issue in OTS's existing chemicals
efforts has been which problems should be addressed by OTS and
which should be "handed-off" to other offices or agencies for
action. A related issue has been what level of analysis OTS
should devote to a problem before "handing it off."
Strictly speaking, the statutory provisions of TSCA section
9, which provide for consideration of other Federal laws in
controlling unreasonable risk, apply only to regulatory actions
under TSCA. However, OTS will be guided in its efforts to
achieve risk reduction voluntarily by the same principles that
would apply in regulatory action on existing chemicals under
TSCA.
Specifically, OTS will retain an existing chemical problem
for further evaluation, voluntary control efforts, or regulatory
control efforts if the available information indicates that the
following four conditions are met:
(1)	the problem poses a significant health or environmental
risk;
(2)	there exists a rationale for action under TSCA that is
likely to achieve a significant reduction in the health
or environmental risk;
(3)	control measures that could be mandated under TSCA are
likely to be cost-effective and control under other
statutes is not likely to be substantially less
burdensome; and
(4)	the problem currently is not being addressed by another
office or agency or that group has requested that OTS
take over responsibility for addressing it.

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IV-14
Conversely, OTS will "hand-off" a problem to another office
or agency when the available information indicates that these
four conditions are met:
(1)	the problem poses or is likely to pose a significant
health or environmental risk;
(2)	there exists a rationale for action under another
statute that is likely to achieve a significant
reduction in the health or environmental risk;
(3)	either there is no appropriate basis for control under
TSCA or action under the alternative statute would
likely be less burdensome in achieving a substantial
risk reduction; and
(4)	the other office or agency agrees to accept
responsibility for further consideration of the problem.
By including criterion (4) immediately above, the term
"hand-off" is limited to those situations where agreement has
been established between OTS and the receiving organization
concerning the transfer of responsibility for the problem. In
cases where OTS evaluation indicates that the problem clearly
poses a significant health or environmental risk (criterion (1)
is met) OTS will actively pursue such agreement before dropping a
problem meeting criterion (3). However, there also will be
situations in which preliminary information or evaluation
indicates to OTS that _if_ there is a significant risk that risk
would likely be more appropriately controlled through the efforts
of another office or agency. In such cases, OTS will refer the
information or problem to the other organization without either
conducting further analysis to determine the risk or attempting
to obtain agreement from the receiving organization that they
will follow-up. Such referrals will be treated as being on a
"for your information" basis.
Some examples of situations in which it may be most
appropriate for OTS to retain existing chemicals problems for OTS
risk reduction efforts (voluntary first, regulatory if necessary)
are discussed below.
(1) Life Cycle Risks
In some instances, the total risk from the manufacture,
processing, use, and disposal of a chemical may be
sufficient to cause unreasonable risk and justify
control action under TSCA, but the risk from each facet
viewed independently may not justify action under other
narrower statutes. This approach was originally
proposed by OTS to control the commercial and industrial
uses of asbestos.

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IV-15
(2)	Risks that "Fall Between the Cracks"
There may be no alternative legislation that could be
used to reduce the risk to large segments of the
population. For example, the OSHA Act excludes
municipal employees. The asbestos in schools program
has been justified, in part, because of the need to
protect municipal employees. There may be other such
situations. For instance, what legislation should be
used to protect people from a toxic dye that may be used
in fingerprinting ink?
(3)	Need for the Broad Authority of TSCA
TSCA provides broad authority that can provide
protection of the public health in ways not afforded by
other legislative authorities, such as the authority to
control commercial use.
For example, chloromethane is a toxic gas that is
odorless. In the past, death and injury occurred as a
result of inadvertent exposure from its use as a
refrigerant. Under section 6 of TSCA, any manner of
commercial use of a substance may be regulated. TSCA
could have been used to require manufacturers to add an
odorant to the gas so that people would be warned of its
presence.
(4)	TSCA Provides the Most Cost-Effective Protective
Mechanism
The OSHA Act can reduce risk primarily by imposing
limits on workplace exposure. On the other hand, the
use of a substance can be prohibited or restricted for a
specific use with TSCA. Such a use control could be
more efficient than workplace controls in certain
circumstances. For example, it could be more cost-
effective to ban the use of nitrites in cutting fluids
to prevent the formation of nitrosamines than it would
be to impose stricter limits on workplace exposure. As
more states move to implement their own OSHA Acts,
industry will be subject to multiple, diverse control
requirements that could be more costly than a single
control under TSCA. For example, separate labeling
requirements for asbestos-containing products by each of
the states might be more burdensome than a single
labeling requirement imposed under TSCA. If so, the use
of TSCA would be consistent with the Administrator's
efforts to impose government controls in the least
burdensome manner.

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IV-16
{5) Control at the Source Avoids Unmanageable Enforcement
A toxic substance might be much easier to control at the
source of supply under TSCA. Once the substance gets
out to the multitude of small workplaces, it may be
burdensome to small businesses and impossible for
government to enforce controls. Workplaces with 10 or
fewer people are excluded from OSHA recordkeeping and
reporting requirements. Thus, the OSHA Act might not be
appropriate to reduce the risk to shoemakers who are
exposed to a toxic solvent in a glue used for shoe
repair.
(6) TSCA Provides a "Scalpel Rather Than a Sledgehammer"
High human exposure and unreasonable risk may result
from one particular use of a toxic substance and that
particular use may not be critical to society if there
are adequate substitutes. In this case, why impose
strict workplace standards and cause high costs to the
rest of the industry when TSCA controls could be applied
selectively?
Although the above examples are presented in terms of TSCA
regulation, OTS will seek to achieve voluntary control of such
risks before moving to a regulatory approach. Nevertheless,
those situations in which TSCA would be most appropriate _i_f
regulation were necessary are those on which OTS will concentrate
its efforts at voluntary control. To do otherwise would foster
situations where OTS responsibilities vis-a-vis other offices or
agencies are unclear and where inefficient transfers of respon-
sibilities would be required subsequently if voluntary control
could not be satisfactorily achieved.

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APPENDICES

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APPENDIX IIIA; FOLLOWUP OF NEW CHEMICALS

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APPENDIX IIIA
FOLLOWUP OF NEW CHEMICALS
I. Importance of a New Chemicals Followup Program
The Office of Toxic Substances states in chapter III that a
credible followup program is a critical part of any new chemicals
program. At the premanufacture stage, EPA's review of chemicals
focuses on the intended methods of manufacture and use described
in the PMN, and decisions must often be made in the absence of
extensive toxicity data. After a new chemical has been entered
on the Inventory, however, unrestricted commercialization is
possible without further data development or EPA review.
Therefore, as a complement to the PMN review program, OTS is
instituting a new chemicals followup program designed to reduce
possible risks from recently commercialized new chemicals and to
encourage data development on these chemicals later in its
commercialization.
This followup program will consist of two elements. OTS
will develop significant new use rules (SNUR's) under section
5(a)(2) on specific new chemicals when it identifies new uses of
sufficient concern. OTS will also use chemical-specific section
8(a) reporting rules to track the commercial growth of selected
new chemicals of concern and effectively to place a bound on
risks that can occur from these chemicals without Agency
knowledge. If judiciously applied, these authorities will impose
a minimal burden on industry, while contributing in an important
way to the development of data on new chemicals and the reduction
of new chemical risk.
OTS's approach is consistent with the general preventive
thrust of TSCA, while reflecting the Congressional directive that
EPA should not unduly impede or create unnecessary economic
barriers to technological innovation. In discussing the case of
vinyl chloride, the Senate Commerce Committee Report stated:
the country has grown extremely reliant on
the plastics which are produced from the
chemical. In fact, 1 percent of our gross
national product is associated with the vinyl
chloride industry. Obviously, it is far more
difficult to take regulatory action against
this chemical now, than it would have been
had the dangers been known earlier when
alternatives could have been developed and
polyvinyl chloride plastics not become such
an intrinsic part of our way of life in this
country. (TSCA Legislative History, p. 161)

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IIIA-2
This passage clearly indicates that risks should be characterized
early in a chemical's commercialization, before an industry is
committed to it and before the costs of regulation would be
excessive. The most appropriate time to act to control a
hazardous chemical, Congress stated, is before unreasonable risks
occur and before heavy costs in jobs and wasted investments would
be incurred. This passage does not imply, however, that a
chemical must be fully characterized before first manufacture,
particularly when the costs of such a characterization would be
excessive and exposure would be adequately controlled.
A three-part strategy to promote the development of test
data on newly commercialized chemicals is needed. This strategy
would modify OTS's current new chemicals program so that it will
be closer in line with the realities of new chemicals development.
First, OTS intends to issue a broad section 5(h)(4) rule
that will exempt certain low-exposure chemicals from PMN
requirements (e.g., low-volume chemicals and site-limited
intermediates). If these chemicals were to be commercialized
beyond the terms of the exemption, they would be subject to
PMN. When PMN's were submitted, OTS would expect data
appropriate for the chemicals's potential toxicity, level of
commercialization, and uses. Since exempt chemicals would not be
placed on the TSCA Chemical Substance Inventory, this approach
would in effect institute a followup requirement for new low-
volume chemicals and site-limited intermediates. This would
eliminate some of the current need for a followup program under
sections 5(a)(2) and 8(a).
Second, OTS will continue to rely on section 5(e) during the
premanufacture review period to gather data on toxicity and will
expand the use of section 5(c) to include information on
exposure. In addition, OTS will use "delayed trigger" section
5(e) orders under certain circumstances to promote data
development at some later point in a new chemical's
commercialization. (See Chapter III for a description of delayed
trigger section 5(e) orders.)
With these two policies in place, OTS will receive fewer
notices on new chemicals (presumably including more data) and
will more frequently request additional data on new chemicals
under section 5(e). Even under these circumstances, however, EPA
will still receive a number of notices on new chemicals that
appear to have potential for significant toxicity, but that do
not warrant section 5(e) action because uses and production
volume described in the PMN indicate low exposure. In these
cases, followup action under section 5(a)(2) or section 8(a) is
the most effective way for the Agency to encourage the
development of appropriate data later in commercialization, to
ensure subsequent Agency review, and to place a bound on risks
posed by new chemicals after commercialization.

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IIIA-3
The use of TSCA authorities to develop such a followup
program was clearly anticipated by Congress. Senator Magnuson,
Chairman of the Senate Commerce Committee, stated in the Senate
consideration of the Conference Report,
the requirement that manufacturing and
processing notices be given for significant
new uses of chemical substances is extremely
important. As chemical substances frequently
are not manufactured in large volumes or for
a large number of uses initially, the
authority to require notification for these
substances as uses mount or as volumes
increase is extremely important. (TSCA
Legislative History, p. 723)
As Congress recognized, EPA's new chemicals program will be
seriously limited without a followup program. Without such a
program, EPA's ability to act on new chemicals and to require
data development will depend entirely on the accident of how the
new chemicals are initially described in the PMN and how the PMN
submitters intend to use them. For example, if vinyl chloride —
the example from the Legislative History cited above — were a
new chemical, EPA's review under section 5 would be limited to a
consideration of the methods of production and the uses described
in the premanufacture notice. If EPA refrained from action in
the absence of data during the review period because exposure was
low in the uses described in the PMN, the chemical could enter
full-scale commercial development without any assurance that its
potential hazards would be further characterized. A major goal
of the new chemicals followup program will be to reduce this
potential problem by making it possible for the Agency to review
new chemicals of concern after they had been entered on the
Inventory but before significant new exposures occurred. To make
the program effective, OTS is committing resources not only to
the development of followup rules, but also to the review of
followup notices and, where necessary, action on chemicals
subject to followup.
OTS recognizes that a new chemicals followup program in some
respects treats new chemicals after commercialization as
different from existing chemicals already on the TSCA Initial
Inventory. This approach is appropriate for several reasons:
o PMN chemicals are in a fundamental sense
different from chemicals on the Initial
Inventory. Unlike chemicals on the Initial
Inventory, they have been subject to EPA
review. If a new chemical that has been
through PMN review becomes the next PCB or
vinyl chloride, this will generally and
properly be recognized as a failure of the
PMN program. OTS could reduce the
possibility of such an occurrence only by

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IIIA-4
requiring complete toxicological
characterization at the PMN stage or by
developing a followup program.*
o The new chemicals program properly addresses
the full range of risks a new chemical may
present as it grows in the marketplace and
uses diversify. Because the PMN review
addresses only the risks described in the
notice, EPA can protect against risks
associated with subsequent commercialization
only through a carefully focused followup
program.
o By its nature, the existing chemicals program
generally deals with high-volume, high-
concern chemicals. For these chemicals, the
costs of regulation may be high. However,
recently commercialized new chemicals, which
have not yet reached maturity in the
marketplace, can be controlled with less cost
before high levels of risk occur.
For these reasons, a broader approach to new chemicals,
including new chemicals followup, is justified. The following
principles will guide OTS's new chemicals followup program:
o EPA will focus its followup activities on
chemicals of concern. Followup will not be
applied indiscriminately.
o Followup requires a commitment of resources
to developing followup rules, reviewing
notices when they are submitted, and acting
on the chemicals as appropriate after that
review.
o Followup reporting requirements will be
structured so that notice occurs before
significant changes in commercialization of
the new chemicals, but after the chemicals
have achieved a certain level of commercial
success. In this way, EPA can act to require
the development of data on a substance or to
* CMA endorsed the concept of new chemical followup in its
recent report, The First Four Years of the Toxic Substances
Control Act (1981). According to this report, "CMA agrees that
some appropriate mechanism may properly be developed to keep EPA
apprised of significant events in the commercial development of
[new] chemicals."

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IIIA-5
control exposure before benefits {e.g., jobs
and investments) would make control actions
overly burdensome.
o While the new chemical followup program will
be operated separately from the existing
chemicals program/ it will not proceed m
isolation. In some cases, problems
identified in the PMN process (or as a result
of new chemical followup) will be part of a
larger problem that the Agency may address in
the context of the existing chemicals
program.
II. Implementation of a Followup Program for New Chemicals
There are two basic authorities under which OTS will issue
followup requirement: section 5(a)(2) significant new use rules
(SNU&'s) and the section 8(a) information gathering authority.
SNUR's, because they allow review of new uses under section 5,
provide a more effective mechanism for preventing risks and
encouraging data development. Section 8(a) rules, while easier
to develop, do not provide EPA with an effective review
mechanism. (Figure 1 summarizes some of the differences between
these two authorities.) For this reason, OTS is developing a
followup program that relies primarily on SNUR's for situations
of high concern supplemented by section 8(a). In this approach,
OTS will issue (1) SNUR's on PMN chemicals for which OTS
identifies significant new uses of sufficient concern, and (2)
8(a) rules requiring manufacturers to report minimal information
on specific PMN chemicals of concern after commercialization.
This program is similar to the followup program recommended in
July 1980 by the Conservation Foundation, an industry-
environmental advisory group.
As explained below, this program will be structured so that
it will impose minimal burdens on industry (both because only
chemicals of significant concern will be affected and little
information would be required). These burdens should be seen as
a tradeoff for reduced information requirements at the time of
PMN submission.* Because of this, economic and regulatory
impacts of this program will be considered within the context of
the new chemicals program as a whole.
* In comments on the proposed PMN forms, CMA couples its
argument for a shortened form with a suggested followup program
that in many respects would be more extensive than the one
suggested here.

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FIGURE 1
COMPARISON OF FOLLOWUP AUTHORITIES
hority
Rulemaking Standard
Applicability
Reporting Trigger
Informat ion
Roquiremdnts
Review and Control
Author
a)
CP"\ "reasonably
requires" infor-
mation
Manufacturers and
processors; email
businesses exempt
unless chemical is
listed under
§5(b)(4)
Any appropriate
trigger, for
example, produc-
tion volume or
specific time
after PMN (e.g.,
3 years)
Any of the infor-
mation listed in
$3 (a) (2); Icqis-
lative history in-
dicates thaL this
list is illus-
trative
tlo mandatory
control under
general TSCA
authorities (r
$5 ( a) ! 2 ) ,
' J 1GW J
•H
voluntary controls
i-t
t-f
M
>
I

a)(2^	New use will be
"significant," con-
sidering factors
listed in
§S(a)(2)(A-D)
flanufacturers and
processors; no
small business
exemption
New oses
Same information
as PMN: inform-
ation listed in
§8(a)(2 *, minus
(F.); test data in
possession or con-
trol; descriptions
of other health and
environmenta I
effects data
EPA must revi»j
under §5; &5(^) and
§5(f) available as
well as other TSCA
authorities
S has interpreted "uses" broadly. The following are examples of a new usei (1) reaching a designated production
ume, (2) a new consumer exposure, (3) uses inconsistent with controls required in a §5(e) order that does not bail
production of a chemical. In general, OTS believes that the notification trigger (i.e., the definition of tha new
should be set at a point where §5(e) action could be possible if a significant new use notice were submitted
hout further data

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IIIA-7
A. Significant New Use Rules
Section 5(a)(2) of TSCA authorizes EPA to determine that a
use of a chemical substance is a "significant new use." EPA must
make this determination by rule, after considering all relevant
factors, including (1) the projected volume of manufacture or
processing, (2) the extent to which a use changes the type or
form of human or environmental exposure, (3) the extent to which
the use will increase the magnitude or duration of human or
environmental exposure, and (4) the reasonably anticipated manner
or methods of manufacture, processing, distribution in commerce,
or disposal. Once a use is determined to be a "significant new
use" for a given chemical substance, persons must notify EPA at
least 90 days before they manufacture or process the substance
for that use. This notice must contain the same information
required in a PMN — i.e., the information listed in section
5(d)(1). (However, OTS would expect that exposure information
would relate primarily to exposure associated with the new use.)
The SNUR requirement may involve greater cost and more
uncertainty to the manufacturer than does the PMN requirement. A
SNUR, in effect, puts the manufacturer or processor on notice
that a problem may exist with a particular use of a given
chemical and that risks should be adequately characterized before
that use occurs. For this reason, TSCA requires under section
5(g) that, if the Agency does not take action on a SNUR notice,
it must publish a notice in the Federal Register stating its
reasons for not initiating action.
Because of the notification costs associated with SNUR's,
these rules might in some cases serve to inhibit the manufacture
or processing of chemicals for new uses designated as
"significant." Manufacturers and processors would commercialize
a chemical for a significant new use only if they determined that
the benefits to be derived from commercialization warranted the
development of the data necessary to allay concerns (or if they
could successfully demonstrate that exposure in the new use would
be lower than anticipated). Such an effect is not only
acceptable but also appropriate, since SNUR's will be used only
when there is a significant level of concern.
OTS intends to issue SNUR's when (1) it believes it would
have a reasonable basis for section 5(e) action on a new use if
additional data were not provided, (2) new uses involving
significant exposure are not unlikely, and (3) EPA review before
the new use occurs (including the possibility of action under
section 5) is in the public interest. Based on OTS's experience
with PMN review, it appears that about ten SNUR's would be
written a year on new chemicals if these criteria are applied.
As a first step, OTS will select several candidates for
SNUR's from among the chemicals that are currently on the
"followup queue." OTS has developed this list of approximately
170 chemicals of potential concern during the past two and a half

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IIIA-8
years of PMN review. Considerable progress has been made in the
past few months identifying reasonable followup candidates from
the queue. A few chemical-specific SNUR's, chosen on the basis
of the criteria listed above, should allay many concerns industry
has expressed about how OTS intends to use SNUR's for new
chemical followup,* as well as provide important protection to
health and the environment. In developing these rules, OTS will
have the opportunity to resolve many specific issues associated
with SNUR's (e.g., how confidential information should be
handled, how "significant new uses" should be defined, etc.).
Although compliance with SNUR requirements will entail a
certain burden, there are several steps OTS will take to ensure
that this burden will be reasonable. For example, OTS might
require notification for a significant new use only after
manufacture or processing for that use had reached a certain
volume. The production volume that would trigger a notice
requirement could be set at a level at which the costs of
developing the data would be reasonable, and at which EPA could
reasonably act under section 5(e) if data were insufficient.
Also, OTS will clearly state the nature of its concern in each
SNUR. Manufacturers and processors could then determine what
data EPA would view as necessary to allay its concerns on how
exposure might be controlled. This could significantly reduce
the uncertainty present in the submission of a SNUR notice.
B. Section 8(a) Information Gathering
Section 8(a) grants the Administrator broad authority to
require manufacturers, importers, and processors to provide
available information to EPA on any TSCA chemicals. This
information can include use information, production volume,
descriptions of byproducts, health and environmental effects
data, exposure information, and disposal information. In issuing
a section 8(a) rule, the Administrator need only find that the
information is "reasonably required." While this finding is less
stringent than the SNUR finding, EPA must still demonstrate sound
reasons for requiring information under section 8(a), and the
costs of the requirement must be justified, given the anticipated
benefits.
Section 8(a) is particularly appropriate for identifying
which PMN chemicals of concern are likely to prove commercial
* In particular, industry has expressed concern about the SNUR
EPA proposed on November 16, 1980, for the new chemical
n-methanesulfonyl-p-toluenesulfonamide (PMN 0016). The approach
OTS is now taking differs in many respects from the approach
taken in this proposed rule — which defined "significant new
uses" very broadly and did not reflect affirmative toxicity
concerns.

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IIIA-9
successes and for tracking specific new chemicals after
manufacture begins. Under section 8(a) rules — which would be
applied only to chemicals of concern — EPA might require minimal
information on production volume and use, as well as available
health and environmental effects data. Reporting might be
required at a specific production volume or after a certain
number of years. Although a section 8(a) rule would not afford
the protection of a SNUR (because it would not allow review under
section 5), it would effectively signal circumstances of major
concern before risks became unreasonable arid before a new
chemical of concern had grown to a point at. which control would
present significant economic costs.
C. EPA Action on Followup Chemicals
An important distinction between followup under section
5(a)(2) and 8(a) is that, under section 5(a)(2), EPA is required
to review the notice, and it has the authorities of sections 5(e)
and 5(f) available to require further data on the chemical or to
regulate the chemical in its proposed new use. In addition, as
mentioned previously, under section 5(g), if EPA does not take
action during the review period, it must publish a notice in the
Federal Register stating its reasons for not taking action.
Under section 8(a), EPA review is not required, and the
Agency does not have the special authorities of sections 5(e) and
5(f). EPA, however, will have the full range of TSCA authorities
available to it to control risks identified as a result of
section 8(a) followup. These include section 4 test rules (and
voluntary approaches to data development in lieu of a section 4
rule), section 5(a)(2) significant new use rules, voluntary
controls by the manufacturer or processor, referral to another
office or agency, and control under section 6. These authorities
should be easier to use as part of a new chemicals followup
program than they have proved for fully commercialized chemicals
because the chemicals will be relatively early in commercial
development. Therefore, costs associated with regulation will be
lower, and industry will have greater flexibility in developing
controls or in turning to alternative chemicals, if necessary.
Relatively few reports are likely to be received under the
new chemicals followup program. Therefore, limited resources
will be necessary to ensure an effective program. The Office is
also adopting the principle that regulatory or other action
against recently commercialized PMN chemicals is appropriate even
if similar risks from existing chemicals are not being
addressed. In other words, regulatory or other action under the
new chemicals followup program will not be driven by the
priorities of the existing chemicals program. Instead, where
action on chemicals subject to followup would encourage the
development of data necessary for an adequate review of risks or
would lead to an appropriate reduction in risks, without imposing
undue burdens, the Office will not hesitate to act.

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APPENDIX IVA: DEFINING A POSSIBLE EXISTING CHEMICALS "PROCESS"

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APPENDIX IVA: DEFINING A POSSIBLE EXISTING CHEMICALS "PROCESS"
Lack of an adopted "process" for identifying, evaluating and
responding to existing chemical problems has hampered OTS's
existing chemicals program since the reorganization of OTS in
1980. The roles and responsibilities of various divisions and
branches in dealing with existing chemical problems have been
confused and each problem or project has been handled largely in
an ad hoc manner. Considerable work was done by OTS during the
first half of 1981 to define a suitable process, but final
decisions on its implementation were not made. Therefore, during
the 100-day initiative OTS took another look at the existing
chemicals process in the lig.ht of the objectives and directions
presented in section B of chapter IV. The highlights of a
possible process OTS could use are presented below. This is
subject to revision as planning proceeds.
The OTS existing chemicals process must perform three
primary functions:
a.	Problem Definition — the process must provide for the
timely and efficient gathering and evaluation of information
necessary to convert a "cause for concern" about a chemical
(e.g., new test results showing adverse effects or new
evidence of exposure to a toxic chemical) into one or more
discrete potential "problems" on wftich further evaluation
can be focused. A properly defined problem should identify
one or more specific chemicals, effects, and exposure
situations that may present a significant health or
environmental risk.
b.	Problem Assessment — the process must provide for
gathering and evaluating the information necessary to
determine whether or not potential "problems," whether
initially identified by OTS or brought to the Office's
attention through such mechanisms as section 8(e) notices or
section 21 petitions, actually pose a sufficiently serious
risk to warrant control efforts by OTS or some other office
or agency.
c.	Problem Response — the process must provide for
identifying the most appropriate approach to controlling
problems found to be serious and for following through on
that approach, whether it be "handing off" the problem for
action by another office or agency, initiating OTS efforts
to achieve voluntary control, or initiating regulatory
action.
The possible OTS existing chemicals process has five stages
(see Figure 1). A Problem Identification and Screening Stage and
an Initial Assessment Stage would carry out the problem
definition function described above. These stages include
verification of potential TSCA applicability to the chemical or
activity involved, preliminary evaluation of information

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IVA-2
triggering the initial concern, and initial gathering and
evaluation of complementary effects or exposure information
needed to define discrete "problems."
A Detailed Assessment Stage would carry out the problem
assessment function. This stage includes in-depth evaluation of
the strength of the evidence that the potential problem poses a
significant risk, together with further data gathering and data
generation as necessary.
A Risk Reduction Analysis Stage and Project Stage of the
process would carry out the problem response function, including
the evaluation of alternative control measures, the "hand off" of
problems identified as posing a significant risk but more
appropriately addressed by others than OTS, and all OTS control
actions.
These are the elements of a tentative existing chemicals
process. OTS will develop and refine these five stages, the
steps within each stage and the procedures for carrying them out
as it proceeds with implementing its existing chemicals program.

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