TSCA PRIORITIES AND PROGRESS
July 1983
Office of Toxic Substances
Office of Pesticides and Toxic Substances
United States Environmental Protection Agency
Washington, D.C.
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This document was prepared and reviewed by the Office of Toxic
Substances. It has not been administratively reviewed within
EPA.
ma** £. cJl-SjI?* ffJts
Authorized Signature and Da^e /
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TSCA PRIORITIES AND PROGRESS
EXECUTIVE SUMMARY
This report, prepared by the Office of Toxic Substances
(OTS) of the U.S. Environmental Protection Agency (EPA), updates
OTS' January 1982 report, "Priorities for OTS Operation." It
describes the OTS1 progress in carrying out the agenda announced
in the 1982 report, the Office's current approach to implementing
the Toxic Substances Control Act (TSCA), and new directions for
the future. The policies and initiatives this report announces
have not been formally reviewed or approved by other EPA offices
or the EPA Administrator. It was developed to provide internal
guidance to OTS staff on the general status of TSCA programs ana
on priorities for future operations. The report is now being
made available to the public for the same purpose. OTS welcomes
comments from members of the public and from interested groups on
any aspect of this report.
I. Introduction
OTS remains committed to the broad program goals announced
in the 1982 "Priorities" document: to provide better guidance
for OTS implementation of its new and existing chemicals
programs; to develop more cost-effective means for achieving
industry compliance; and to strengthen OTS operations. Wisjiin
this broad framework, OTS has considerably refined, focused, and
in some cases redirected its activities. In doing so, it is
working toward six broad program objectives:
o To ensure the development of adequate data on both new
and existing chemicals.
o To monitor the commercial development of new chemicals
more closely after they have completed premanufacture
review.
o To use TSCA regulatory authorities more flexibly and
effectively to ensure that existing chemical hazards are
promptly reviewed and controlled.
o To refine and expand the analytical and technical tools
used in support of the OTS' regulatory programs.
o To share information developed under TSCA more
effectively and to promote technical exchanges with other
agencies and the public.
o To integrate OTS* new and existing chemicals programs
more closely.
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II Mew Chemicals Program
The basic framework of OTS1 new chemicals program, as
outlined in the 1932 "Priorities" document, is now in place.
Final premanufacture notice ( PMN) rules for new chemicals have
been issued; OTS is more frequently taking action on new
chemicals to control exposure and to ensure that adequate aata
are developed; broad-based exemptions from PMN requirements have
been proposed for certain polymers, s l te-limitea intermediates,
and low volume chemicals; and a case-specific new chemicals
followup program has been incorporated within the new chemicals
review process. With this framework in place, OTS will be
concentrating its efforts for the next year on the following
activities:
o Premanufacture review of new chemicals, with continued
use of §5(e) and other mechanisms to encourage data
development and control exposure to new chemicals of
concern.
o Development of a general §8(a) followup rule for new
chemicals, based on proauction volume, to complement the
current case-specific new chemicals followup program.
o Use of Advisory Circulars to communicate the rationale
behind new cnemical decisions and to provide guidance to
new chemical notice submitters.
Refinement and validation of tecnnical tools usea by OTb
in PMN review, including the development of data bases
and analytical techniques based on structure-activity
relationships.
III. Existing Chemicals Program
Since publishing the January 1982 "Priorities" document, OTS
has developed an integrated existing chemicals program, capable
both of identifying potential proolems and of bringing them to
resolution. Approximately 60 substances have been or are now
under review in this program. About one-fourth have been dropped
frcm active review; two-thirds have been targeted for further
analysis and preliminary decisions with 12 months; and tive have
moved into regulatory development.
The basic objectives of the existing chemicals program
are: (1) to identify potential risks through TSCA mechanisms;
(2) to ensure the development of data adequate to assess those
risks; (3) to ensure that these risks are addressed under the
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appropnate regulatory autnonty; and (4) where tnat authority is
TSCA, to ensure that appropriate action is taken. Examples of
recent activities are:
o An Advance Notice of Proposed Rulemaking (ANPR) on .^BOCA
( 4 , 4 1 -methyleneb is ( 2-chlorobenzeneamine ) ) , a curmy agent
used in plastics, which has been snown to be carcinogenic
in several species of animals.
o Designation of "-IDA (4,4'-me thylenealan11ine) , a nigh-
production volume chemical intermediate for high priority
review under §4(f) of TSCA.
o Establishment of an interagency Federal Asbestos Task
Force to coordinate federal activities concerning
asbestos; promulgation of a §6 rule requiring school
inspections for asbestos and a §8(a) rule requiring
industry to submit information on asbestos manufacture,
processing, and disposal.
o Promulgation of §6 rules governing certain aspects of the
use of PCB's (polychlormated biphenyls).
o Proposal of a §3(a) reporting rule for chlorinated
terphenyl and a §5
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o When immediate regulation is not warranted or feasible,
use of the §5(a)<2) "significant new use" authority to
prevent existing chemicals of concern from expanding in
production volume or use vithout prior EPA review.
o Use of nonregulatory mechanisms, such as Risk Management
Advisories, either by tnemselves or in connection vith a
rulemaking, to Dring problems more promptly to the
public's attention.
As a complement to the existing chemicals control program,
GTS' §4 test rules program is now operating effectively. The
Office has successfully met a court-ordered schedule for
responding to a oacklog of Interagency Testing Committee (ITC)
recommendacions for test rules, ana it is responding to current
ITC recommendations within the statutory 12-month period. In
total, by the end of 1983, OTS will have responded to ITC
recommendations on 64 chemicals or chemical categories. As the
backlog of ITC chemicals is eliminated, OTb will develop test
rules on substances not designated by the ITC- The Office
anticipates that it <*ill begin its first §4 efforts on a non-ITC
chemical within the next year, with proposal in fiscal year 1984.
To support these programs, OTS conducts a wide range of
chemical monitoring activities. These activities include studies
monitoring the level of PCB's and other chemicals in human tissue
samples, monitoring asbestos in schools ana public buildinys, and
identifying and evaluating exposure to specific chemicals unaer
review. These monitoring activities are closely integrated with
the Office's existing chemicals program, and they provide direct
support to OTS' regulatory agenda. Within the next year, they
will oe used to identify candidates for botn testing ana control,
and they will provide exposure information necessary for ongoing
OTS reviews.
OTS is also taking steps to ensure that its new and existing
chemicals programs are coordinated. It has now developed or will
soon be developing in the near future a number of mechanisms to
promote a more unified overall program. These include:
o Use of the PMN review process to identify chemicals for
review in the existing chemicals program.
o Use of generic assessments developed in the PMN process
to support existing chemicals review.
o Use of physical-chemical estimation, structure-activity-
relationship, and modeling techniques developed for the
PMN review process in existing chemicals review.
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o
Use ot health and environmental
unaer other TbCA authorities to
c hemicals.
effects
support
data developed
tne review or new
o Use of the §5(a)(2) significant new use authority to
place a limit on the growtn of existing chemicals until
adequate data are developed or their safety is otnerwise
ensured .
IV. Technical Developments
A major priority of OTS has been developing analytical tools
-- such as computerized data bases, environmental fate models,
SAR (structure-activity-relationship) techniques, standardized
test methodologies, and quality assurance procedures to
support its chemical risk assessments and regulatory
activities. During the next year, the Office will commit
significant resources to the further development of these tools
and will continue to integrate them into the decisionmaking
p rocess.
Several important areas of development are:
o Data systems. OTS is developing several internal systems
to provide ready access to data submitted under TSCA and
to data on specific areas of OTS concern, such as genetic
toxicity, aquatic toxicity, and cnemical rate. These
include computerized data bases such as SPHERE and
systems for indexing and organizing TSCA suDmissions
under §8(d) and §8(a).
o Models and analytical tools. OTs uses a Droad range of
estimation techniques to predict the physical-chemical
properties of chemicals from their structure, and it has
developed a number of computer models to estimate
environmental fate, population exposures, and nealtn
risks. Several projects are now underway to refine and
expand these tools.
o SAR development and validation. OTS is now conducting or
sponsoring a series of projects to refine and validate
its use of structure-activity relationships in chemical
review. These activities are essential in determining
the level of confidence that should be assigned to
specific techniques, and they will significantly expand
the Office's present capabilities.
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o Pnority-setung metnods. Along .vith other groups sucn
as the ITC, OTb nas encouraged ana sponsored cne
development of chemical scoring ana priority setting
systems to aia in selecting chemicals for turther
evaluation from among large numbers of candidates.
o Quality of data. To ensure the integrity of its aata,
OTS has aevelopea health, environmental effects, and
cnemical fate testing guidelines; it vill soon oe
prescribing good laboratory practices for TSCA testing;
in cooperation with the Food and Drug Administration, it
periodically inspects and audits laboratories conducting
tests under TSCA; and it is conducting a Gene-Tox Program
to evaluate the current status of genetic toxicology.
OTS also has an active quality-assurance program to
assure the integrity of data developed in its monitoring
proj ects.
V. Information Sharing and Technical Exchange
TSCA gives EPA unique authority to gather or require the
development of a wide range of production, exposure, and health
ana evironmental effects data on commercial cnemicals. Mucn of
the information collected under TSCA is potentially of great
value to the public, states and local governments, EPa regions
and other EPA offices, other federal agencies, and other
nations. From the beginning, OTS has assigned a high priority to
sharing such information and promoting technical excnanges .
Current initiatives in this area include:
o Developing Risk. Management Advisories for selectea
existing chemicals and Advisory Circulars for new
c hemicals.
o Publishing quarterly reports identifying chemicals under
evaluation in the existing chemicals program.
o Providing access to a number of OTS data bases now under
development, such as SPHERE.
o Promoting technical exchanges with states, federal
agencies, and foreign nations (such as the current OTS
agreements with the Federal Republic of Germany and the
Michigan Department of Natural Resources to share
computational and modeling capabilities).
o Publishing nonconfidential aggregations of data from
confidential data bases (sucn as reports on asbestos or
ITC chemicals submitted under §8(a)), so that the public
has as much access as possible to this information.
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Entering into agreements with other regulatory agencies
that provide them restricted access to T3CA confidential
information.
o Establishing a program to ensure setter information
exchange and coordination between OTS and the toxics
programs of individual states.
o Exploring the possibility of using the TS'CA infornacion-
gathering authority (for example, § 8 ( a}} to support other
EPA offices and other federal agencies.
Addendum
OTS is now exploring several additional initiatives that are
early in their planning stages ana have not yet been fully
articulated. Before decisions are made to pursue these
initiatives or how far to pursue them their policy, legal,
and resource implications will require further review. For this
reason, some of the initiatives may not be adopted wnile others
may oe phased in gradually as the Office continues to gain
experience in its new and existing chemicals programs. riowever,
tnese initiatives represent alternative routes that OTS is now
exploring to reach its overall program goals:
o Place categories of substances that have raised concern
in the PMN process on the § 5 ( b) ( 4 ) "risk list."
o Issue §4 test rules for chemical categories that have
raised concern in the PMN process.
o Develop a "me-too" SNUR automatically extending the terms
of §5(e) orders to subsequent manufacturers ana
processors.
o Issue §8(a) followup rules together with new chemical
significant new use rules.
o Develop a TSCA biotechnology program to ensure that risks
from TSCA uses of genetically engineered material are
appropriately controlled.
o Issue triggered §4 rules to require testing of low
production volume/exposure/release chemicals for wnich
existing data indicate a need for testing it production,
exposure, or release were to increase.
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o Issue significant new use rules on §4 chemicals to ensure
that procuction does not increase or new uses develop
oefore testing is completed.
o Update the TSCA Chemical SuDScance Inventory tnrough a
§8(a) rule.
o belect existing cnemicals nor OTb evaluation oy "cluster"
analysis, a priority-setting system that would assign
aggregate measures of risk to categories of chemicals
with similar uses or structures.
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TSCA PRIORITIES AND PROGRESS
Pre face
I. Overview of OTS Initiatives
II. New Chemicals Program
A. Introduction
B. Premanufacture Review Program
1 .
PMN Rule
2 .
New Chemicals Review
3 .
Regulatory and other Actions
C.
PMN
Exempt ions
D.
New
Chemicals Followup
Ex l
st l ng
Chemicals Program
III.
A. Introduction
B. Existing Chemicals Regulation
1. Identification of Regulatory Candidates
2. Existing Chemicals Control
C. Section 4 Testing Program
D. Monitoring Chemical Exposure
E. Coordination of New and Existing Chemicals Programs
IV. Technical Developments
A. Introduction
B. Data System Development
C. Models and Analytical Tools
D. SAR Development and Validation
E. Priority Setting Methods
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P. Quality of Data
1. Test Data
2. Exposure and Monitoring Data
V. Information Sharing ana Technical Exchange
A. General Background and Current Activities
3. International Activities
1. OECD Chemicals Program
2. United Nations Programs
3. Bilateral Activities
Adde ndum
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PREFACE
In January 1982, the Office of Toxic Substances (OTS) issued
a report, "Priorities for OTS Operation," describing the general
goals and objectives of the Office in implementing the Toxic
Substances Control Act (TSCA). The report focused primarily on
OTS' new and existing chemicals programs, conducted under §5, §6,
ana §8 of the Act. It described the Office's basic strategy for
identifying and controlling risks from both new and existing
chemicals, and it defined priorities for future OTS activities.
In the year and a half since this report was prepared, OTS
has substantially accomplished the program goals that the report
announced. Furthermore, OTS' experience during this period has
confirmed the basic principles stated in the 1982 document and
the general framework it laid out for both the new and existing
chemicals programs. In conducting its ongoing programs, however,
OTS has come to identify possible refinements within the general
program framework, goals toward which more attention should be
focused, and new initiatives that should be explored. The
present report, "TSCA Priorities and Progress," updates the 1982
"Priorities" document, by describing the Office's progress in
carrying out the agenda announced in that document, OTS' current
approach to implementing TSCA, and new directions for the future.
In addition to updating the 1982 document, the present
report significantly broadens its scope. The 1982 "Priorities"
document was for the most part limited to OTS' new chemicals
review program under §5 of TSCA and its existing chemicals
control program under §6 and §8. The present report describes
progress, refinements, and new initiatives within these
programs. However, it also adds a discussion of OTS' activities
under §4, which gives EPA the authority to require health and
environmental effects testing of chemicals. At the time of the
earlier report, 0"ts §4 testing program was faced with a series of
court-ordered deadlines, and therefore its priorities were
clearly set. As these deadlines are met, however, OTS will have
greater flexibility to implement §4 more broadly. In addition,
the present report discusses OTS initiatives in two major areas
central to its mission technical tool development and
information exchange with other Federal agencies and the
public. The Office devotes considerable resources to these
areas, which are vital to the success of its overall program, and
expects significant progress in both.
The report also includes an Addendum describing possible OTS
initiatives in the future. The initiatives described in the
Addendum have not been fully developed, and some may not be
possible given current resource constraints, but they represent
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alternacive routes OTS is now exploring to reach its overall
program goals.
This report has not been formally reviewed or approved by
otner EPA offices or the EPA Administrator. It is an UTS staff
document developed to provide internal guidance to OTS stafr on
the general status of TSCA programs and on priorities for future
operations. The report is now being made availaDle to the public
for the same purpose. OTS welcomes comments from members of the
public and from interested groups on any aspect of this report.
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CHAPTER I
OVERVIEW OF OTb INITIATIVES
In January 1982, OTS announced a coordinated program to
identify and control chemical hazards unoer the Toxic buostances
Control Act. At that time, OTb identified three major program
goals:
o To provide better guidance for OTS implementation of its
new and existing chemicals programs.
o To develop more cost-effective means for achieving
industry compliance.
o To strengthen OTS operations.
In the past year and a half, OTS has taken significant steps
in achieving these program goals. At the same time, the Office's
day-to-day experience in carrying out this agenda and in
conducting its new and existing chemicals programs has allowed it
to refine, focus, and in some cases redirect its activities. On
the basis of this experience, OTS has identified six najor
program objectives for the next year, as well as a series of
initiatives designed to accomplish each:
o Ensuring adequate data development on both new and
existing chemicals. OTS will continue to use its §5(e)
authority more frequently on new chemicals, limiting
production of chemicals of concern pending the development
of data, and it will encourage premanufacture notice
suspensions to allow health and environmental effects
testing before manufacture begins. The Office is also
exploring the possibility of listing categories of new
chemicals under TSCA §5(b)(4) or issuing §4 test rules on
selected new chemical categories to ensure adequate data
submissions under the PMN program. In addition, OTS will
continue to use the §4 authority flexibly to eliminate
OTS' court-ordered testing backlog and to respond promptly
to future Interagency Testing Committee (ITC)
designations. Finally, OTS will begin to develop test
rules on chemicals identified through mechanisms other
than the ITC.
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o Using TSCA regulatory authorities more effectively ana
flexioly to ensure that existing cnemical risks are
promptly reviewed and controlled. The overall goal is to
resolve problems identified through standard TSCa
mechanisms more quickly and more effectively. Important
strategies for achieving this goal are close coordination
with other regulatory agencies where responsibilities
overlap; earlier publication of Advance Notices of
Proposed Rulemaking, betoce the details of the various
possible regulatory approaches have been completely worked
out; the use of the §5(a)(2) "significant new use"
authority to prevent existing chemicals of concern from
expanding in production volume or in uses without prior
EPA review; and the use of nonregulatory mechanisms, such
as Risk Management Advisories, to bring problems more
promptly to the public's attention.
o More closely monitoring the commercial development of new
chemicals after they have completed premanufacture
review. OTS will continue to implement a case-by-case
followup program, under the "significant new use"
authority of §5(a){2) and the §8(a) information-gathering
authority. The Office also intends to develop a general
§3(a) new chemical followup rule, which would require
companies to notify EPA when the annual production volume
of a new chemical reached a certain level. This will
provide a general safety net, giving EPA the opportunity
to reevaluate new chemicals after they nave completed
premanufacture review and have grown in the marketplace.
In addition, OTS is considering a "me-too" §5(a)(2) rule
that would automatically extend restrictions imposed on
PMN submitters unaer §5(e) to other companies that might
manufacture or process the new chemical.
o Further developing analytical and other technical tools to
support the regulatory obiectives of the Office. OTS now
has several projects underway to refine ana expand its use
of structure-activity analyses, which in the aDsence of
complete data help to identify potential health and
environmental effects of new chemicals that will require
further evaluation; to develop computerized and other data
bases specifically adapted to OTS needs; to design ana
carry out field monitoring studies to support chemical
regulation and to identify potential problems; and to
implement quality assurance procedures to ensure the
integrity of scientific data under review. OTS1
commitment in this area includes not only the refinement
and development of these tools, but also their full
integration into the OTS decisionmaking process.
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o More effectively sharing information developed under TSCA
and promoting technical exchanges with otner agencies ana
the public. TSCA provides OTS unique ability to collect
information on commercial chemicals and chemical risks,
and it imposes a corresponding responsibility on OTS to
share this information with other agencies and the
public. OTS is committed to expanding its mechanisms for
sharing data with other groups. These include agreements
with other regulatory agencies allowing them access to
TSCA confidential business information, to the extent this
can be done under the Act; dissemination of
non-confloentlal data through the National Technical
Information Service and other mechanisms; tecnnical
exchanges at the state, regional, national, and
international levels; and the use of Risk Management
Advisories and Advisory Circulars to communicate data or
the results of OTS analyses more promptly. In addition,
OTS is committed, where appropriate, to using TSCA
information-gathering authorities (such as §8(a)) to
support other EPA program offices or other regulatory
agencies. For example, OTS is exploring the possibility
of updating the TSCA Inventory, in part because of the
support it vould would provide to the EPA utfice of Solid
Waste, the SPA regions, and otner offices.
o More closely integrating the new and existing chemical
programs. This includes referral to the existing
chemicaIs program of categories of chemicals that have
repeatedly proved of concern in the PMN program, and tne
use of §5(a)(2) significant new use rules on existing
chemicals, orinying tnem under §5 authority. uTb is also
working to ensure the ready access ot both programs to the
data, analyses, ana analytical tools or eacn.
The remainder of this report discusses the status of OTS'
programs, its general progress in implementing a coordinated TSCA
program, and its specific progress in the initiatives descrioed
above.
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CHAPTER II
NEW CHEMICALS PROGRAM
A. Introduction
In "Priorities for OTS Operation" (January 1982), OTS
announced an integrated new chemicals program based on four major
elements:
o Completion of the final premanufacture notice (PMN) rule,
with a mandatory form for new chemical notices, specifying
minimum information requirements needed for a preliminary
review of the chemical.
o Priority placed on review of PMN's, with increased use of
§5(e) to induce the development of data and to control
exposure.
o Development of PMN exemptions under §5(h)(4) to reduce the
notice review burden for low-risk chemicals.
o Establishment of a followup program through §5(a)(2)
significant new use rules and §8(a) reporting rules to
monitor the development of selected new chemicals of
concern.
Since the preparation of the 1982 report, OTS has taken
major steps toward implementing this program. These steps
include the promulgation of a final PMN rule; the continued
operation of an effective PMN review program, with a more
aggressive approach toward requiring data on new chemicals and
controlling exposure in cases of potential risk; the proposal of
limited PMN exemptions for selected site-limited intermediates,
low volume chemicals, and polymers; and the development of a new
chemical followup process, with several significant new use rules
proposed or under development. Together these steps implement
the basic framework of the new chemical program outlined in the
"Priorities" document.
Equally important, in its almost four years of new chemicals
review, OTS has gained invaluable experience that has led to a
more effective review of new chemicals, allowed the refinement of
the current program, and indicated directions for further
development. Recent experience has confirmed the basic
observations on new chemicals review made in the "Priorities"
document, while providing a clearer focus in certain areas. With
the perspective of an additional year and a half of new chemicals
review, the following observations can now be made:
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o The number of new chemical notices submitted for review is
increasing steadily and has now reached the rate of about
1,200 a year. The large number of PMN's received has
necessitated not only a carefully coordinated review
process, but also a reliable institutional memory.
o The review of new chemicals must be undertaken in an
atmosphere of considerable uncertainty, even when a base
set of toxicity data is available. Near certainty can
only be attained from a wide range of acute and chronic
tests for both health ana environmental effects. Such
testing is not practical for most new chemicals. For this
reason, it has been necessary in PMN review for OTS to
rely on structure-activity analyses as a screening tool to
help in estimating potential for hazard, ana to assume
reasonable worst cases in assessing potential exposure.
o The amount of test data received on new chemicals has
remained relatively constant and has generally focused on
physical-chemical properties and acute toxic effects.
While this may be appropriate in some cases, in others the
lack of data complicates the Office's review. Lack of
data on specific PMN chemicals has led to review
suspensions, requests for the voluntary submission of
additional data, withdrawn notices, and in some cases
regulation under §5(e).
o Because of the wide variety of new chemicals received in
the program, decisions on what data are appropriate on a
given new chemical, for the most part, are best made on a
case-by-case basis. Given the diversity of new chemicals,
generic approaches to data 'development are less
appropriate.
o OTS experience continues to indicate that a significant
number of new chemicals now subject to PMN are of
relatively low concern and do not warrant extensive
testing at the time of PMN submission. Many of these
chemicals can be eliminated early from PMN review. The
proposed exemptions for certain site-limited
intermediates, low volume chemicals, and polymers would
allow the earlier commercialization of many of these
chemicals with no increase in risk over the current
approach.
o At an early stage in their life cycle, most new chemicals
are particularly vulnerable to additional costs. Testing
costs imposed at such a stage will impede chemical
innovation to some extent. Therefore, OTS must impose
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such costs prudently and take care to avoid impeding tnis
innovation unauly. Also, in conaucting ics new cnemicals
program, OTS shoula attempt to channel innovation towaro
safer substitutes £or existing nazards.
o At the time PMN's are reviewed, it is otten difficult to
know which new chemicals are likely to be commercial
successes, and how circumstances of exposure miynt
change. As a result, any successful new cnsmicais
followup program must include a relatively broad-based
followup requirement, as well as cnemica1-spec1tic actions
targeted at specific concerns.
As the remainder of this chapter discusses, these observations
are reflected in OTS1 current new chemicals program, ana the
lessons drawn from them have shaped its future directions.
B. Premanufacture Review Program
Since the beginning of the premanufacture review program,
EPA has reviewed more than 2,300 new cnemicals -- approximately
1,30U since the release of the "Priorities" document in January
1982. The effective review of these chemicals remains the first
priority of the overall new chemical program. Consequently, OTS
has devoted significant resources to refining tne PMN review
process, to developing appropriate analytical tools for new
chemicals review, and to reviewing and if necessary regulating
new chemicals.
1. PMN Rule
In the earlier "Priorities" document, OTS stated that it was
moving ahead to issue a final premanufacture notice rule,
clarifying the §5 new chemical notice requirements. EPA naa
published proposed rules in January and October 1979 ana was
operating the new chemicals program under an interim policy
sta tement.
The final rule, together with a mandatory notice form, was
issued in May 1983 (48 FR 21722). The rule reflects almost four
years of OTS experience in PMN review and incorporates extensive
comments from public interest groups and industry. It includes
the following basic requirements:
o Information requirements for premanufacture notices (e.g.,
chemical identity; production volume; use; information on
manufacture, processing, and disposal; available test
data). These requirements, which follow the statutory
requirements specified in TSCA §5(d)(l), provide enough
information for an initial EPA screen of new chemicals.
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Use of a mandatory form by notice submitters. (An
Instructions Manual has also been developed to assist
submitters in completing the form. ) By standardizing
notice submissions, this form simplifies UTS' review,
facilitates the entry of data into automated data bases,
ana promotes consistency in decisionmaking; it also
provides a clear standard to industry concerning data
requireme nts.
Confidentiality procedures, including instructions on
claiming information confidential and a requirement that
companies provide "sanitized" versions of confidential
submissions for inclusion in the public file. The
confidentiality procedures, which ensure consistency in
the handling of confidential business information, are
designed to achieve a balance between public access to
information and the protection of legitimate trade
sec rets.
o Specification of notice review procedures, including
definition of "incomplete submissions," which fail to meet
the basic statutory requirements and therefore are not
considered PMN's.
o Submission of a Notice of
companies when they begin
has completed PMN review,
add new substances to the
begins, establishing them
subject to PMN review.
Commencement of Manufacture by
production of a substance that
This requirement allows EPA to
TSCA Inventory when production
as existing chemicals not
In addition, OTS is working to clarify key statutory terms,
such as "research and development" chemicals, which are exempt
from PMN review, and to provide guidance on other requirements,
such as the level of detail that must be provided on test data
submitted in PMN's.
OTS is also developing a rule under §8(a) that will require
companies to notify it before they make a new chemical solely for
export. Because export-only new chemicals are not covered by §5
prenotice requirements, this rule will fill a gap in PMN
coverage.
Through these and other provisions, the PMN rule sets the
basic framework of the new chemicals program, providing industry
with clear standards for compliance, simplifying EPA's review of
new chemicals, and contributing to the program's consistency.
With this rule in place, OTS is now able to focus more of its
resources on other aspects of the new chemicals program.
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2. New Chemicals Review
In addition to issuing the PMN rule, which vill standardize
information submissions and notification procedures, OTS has
focused and refined its new chemicals review process so that it
can more effectively review the large number of notices now
received. Important refinements that have been instituted or are
now under development include process modifications to eliminate
low concern chemicals from review early; the development of data
bases to allow ready access to information; the preparation of
g neric assessments of recurring concerns in the PMN process; and
the development and use of structure-actlvity-relatlonship (SAR)
techniques to identify chemicals for further evaluation.
The major modification in the new chemicals review process
is the establishment of a staged approach, reflecting the fact
that a large number of new substances are of low concern not
requiring in-depth review. In the earlier process, most
substances were subjected to a standard 45-day "initial screen,"
which meant that consideraDle resources were committed to the
review of low-concern chemicals. OTS now drops these substances
from review after a preliminary review of chemical identity,
available test data, use, and exposure factors. To identify such
substances effectively, UTS has instituted an early decision
meeting attended by senior OTS decisionmakers; as a result, up to
40% of substances are cropped from review by day 16 of the
process. The meeting also serves to focus the further review of
substances that are not cropped. This approach has allowed the
Agency to use its resources more effectively and to concentrate
them on chemicals of potentially greater concern.
OTS is also taking important steps to ensure that its
accumulated experience in new chemicals review is brought to bear
fully on each case. Because most "new substances" seen under
TSCA belong to chemical or use categories that have been subject
to past review, the retrieval of information from these reviews
has been particularly important in the PMN program. Similarly,
access to data received under other TSCA authorities or analyses
performed by other OTS programs also contribute significantly to
PMN review. As more PMNs are received, and as more data are
submitted under §4, §5(e), §8, and other authorities, the
Office's accumulated experience will become increasingly
important in the review of PMN's, and the ability to call upon
this experience readily will become essential in ensuring the
consistency of OTS decisions. The following initiatives begun in
the past year will contribute significantly to this goal:
o Automation of data from previous reviews. OTS has
developed an automated PMN file, to allow ready access to
information from previous reviews. This data base, which
is discussed more fully in Chapter IV, is now being
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substantlally upgraded to include summaries of past OTS
reviews arid the key findings of those reviews.
o Development of generic analyses of recurrent issues. OTS
has conducted several "generic" analyses of technical
issues arising repeatedly in PMN review, including studies
addressing specific industry sectors, chemical categories,
and similar topics. For example, the Agency has completed
a study of technical issues raised in the review of
certain dyes. These studies provide OTS staff with m-
depth analyses that typically could not be performed in
the statutory time frame for PMN review. Also, they have
served as starting points for discussions with industry.
The Agency has met with industry groups to discuss issues
raised by several assessments and to encourage industry to
provide data that could resolve Agency concerns. For
example, certain azo dyes and certain lubricant additives
known as ZDDP's are now under discussion with industry
groups. Cooperation with industry and other groups on
these broader issues may in some cases encourage data
development more effectively than case-by-case
requirements on PMN's.
o Development of data systems allowing ready access to data
obtained in other OTS activities. OTS is developing
various data bases allowing quick access to information
submitted under TSCA or used in OTS analyses. These
include SPHERE, vhich will allow on-line access to a wide
range of physical-chemical properties, health ana
environmental effects, and other data; and a Global
Indexing system for §8(d) submissions and other OTS
documents.
o Development of a nonconfidential tracking system for the
PMN program. OTS has developed a tracking system that
provides the status of PMN's under review and the schedule
for the reviews.
In addition, OTS is now refining its use of SAR techniques
in evaluating the adequacy of data submitted in PMN's. These
techniques (which involve the analysis of chemical structure for
insight into physical-chemical properties and toxicity) are
particularly important because of the variety and number of
chemical substances received in the PMN program, as well as the
limited amount of data generally received on new substances. At
one extreme of the new chemicals seen in the program are
substances that belong to chemical classes, or have structural
features, that make them highly suspect toxicologically. At the
other extreme are chemicals belonging to classes that are
generally recognized as low in toxicity. No one level of testing
would be appropriate for all of the chemicals falling within
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these extremes. Determining the appropriate level o£ testing for
a jiven chemical, ana the nature of that testing, therefore,
depends in part on an evaluation of chemical structure and analog
data that is, on SAR analysis. This analysis is not a general
replacement for testing; rather, SAR considerations, along with
such exposure factors as manufacturing process, use, ana
production volume, is used to determine whether a new chemical
has been adequately tested ana, if not, what further tests woula
be appropriate.
SAR analysis occurs at several different levels during PMN
review. First, OTS has organized and developed techniques to
estimate certain physical-chemical properties critical to
exposure assessment (e.g., vapor pressure, octanol-water
partition coefficient, water solubility) from a chemical's
structure. These techniques, which are discussea in Chapter IV,
are routinely used in PMN review to supplement test data on the
new chemical. Second, OTS relies primarily on the professional
judgment of senior scientists to identify chemicals of possible
health or environmental concern. These judgments are based on
available test data, the chemical's structure, analog data, and
similar factors. Examples of the kind of structural factors that
might indicate a concern with a chemical are:
The substance is structually analogous to a chemical of
known concern or a member of a class of substances some
members of which are known to exhibit toxic properties.
The molecule has substituent groups that are often
associated with a toxicological response of concern.
The substance is likely to be transformed to metabolites
that are structurally related to substances that have
demonstrated effects of concern.
o The molecule has characteristics that may indicate
potential toxicity, based on known mechanisms of action.
The review of such factors in the case of any given chemical
requires considerable expertise and the knowledge of a wide range
of toxicological data. The development of systems that allow OTS
scientists ready access to a wide range of data will greatly
enhance their ability to perform these reviews.
In the final analysis, the use of SAR in the review of new
chemicals reflects the recognition that existing literature and
past experience with chemical substances are powerful sources of
insight into the potential toxicity of chemical substances and
that such insight should be used to focus evaluation of new
c hemicals.
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OTS has several projects underway to refine, expand, ana
validate its use of SAR in PMN reviews. These projects are
discussed in Chapter IV.
3. Regulatory and Other Actions
In the earlier "Priorities" document, OTb indicated that it
would rely increasingly on its §5 regulatory authorities and
other mechanisms in conducting new chemicals review. The recent
record of the PMN program demonstrates the Otfice's commitment to
this policy. From the beginning of the PMN program in 1979
through June 1983, the Agency has issued nine §5(e) orders
banning or controlling exposure to 20 chemicals, pending the
development of additional data; four of these orders have been
issued this year. In addition, eight to ten more orders are now
being pursued and may be issued in the next two months,
indicating a sharp increase in activity. Also, the notice review
periods for 30 substances are currently under suspension to allow
further OTS review or to give the submitter an opportunity to
develop additional data. Further testing has been or is being
performed for 29 substances.
This increased activity reflects in part the fact that the
PMN review process, after several years of operation, is working
smoothly and efficiently. With its experience in new chemicals
review and regulation, OTS can now act more quickly to identify
potential problems or gaps in data. More important, perhaps, the
increased activity reflects several operating assumptions derived
rom the Office's recent experience in reviewing rMN's:
o Section 5(e) orders banning or limiting production are
appropriate when the toxicity of a new chemical substance
is not well characterized and exposure is likely to be
relatively high, or when the potential adverse effects are
likely to be serious, even if exposure is likely to be
relatively low.
o The Office originally focused most of its attention on
carcinogenicity, mutagenicity, and teratogenicity.
Without reducing its attention to these effects, it now
considers action under §5(e) because of other potential
effects. One recent §5(e) order, for example, prohibited
the use of two new chemicals in consumer products until it
was tested for eye irritation at likely concentrations in
consumer products. In PMN review, OTS is also placing
increased emphasis on neurotoxicity, reproductive
toxicity, and other effects.
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o OTS now issues §5(e) orders to ensure that submitters
maintain exposure controls that they acopted voluntarily,
either on their own initiative or as a result of
negotiation with OTS during the PMN review period. Unless
a §5(e) order is issued in these circumstances or other
regulatory action is taken, the manufacturer would not be
required to maintain these controls. Because these
controls are part of a §5(e) order, they are monitored
EPA's enforcement office.
o OTS increasingly empnasizes "significant or substantial
exposure" and "significant release" in deciding to take
§5(e) action. Where these standards are met, and where
health and environmental effects data are insufficient tor
a reasoned evaluation, EPA can act to control a new
chemical, pending the development^ of data, even in the
absence of affirmative evidence of potential risk. EPA
recently issued a §5(e) order controlling the manufacture
of new shale oil products under this standard.
To put these principles into practice, OTS has adopted a
more flexible approach to §5 regulation. Two developments
voluntary notice suspensions pending the development of data and
the negotiation of consent orders under §5(e) -- have proved
particularly fruitful.
First, OTb frequently encourages companies to suspend notice
review periods voluntarily when it has identified data gaps, so
that the companies can develop additional data to meet its
concerns. OTS has found cnat companies are often willing to
suspend the review period in these cases it data gaps are
identified early in PMN review. This is especially true in the
case of data that can be developed promptly such as data from
acute health effects tests, in vitro carcinogenicity screens, and
aquatic toxicity tests. If the company is informed of data gaps
early, it can complete the tests and submit the results for OTS
review without major delays in commercialization (assuming the
tests confirm the chemical's safety). Consequently, OTS has
taken procedural steps to ensure that senior decisionmakers
confirm data needs early in PMN review and that these needs are
promptly communicated to notice submitters.
In one case, for example, OTS was concerned that an
imported, fiber-reactive dye for cotton fabrics was potentially
carcinogenic. Concern focused on exposure to workers involved in
dyeing operations in textile mills and releases to drinking water
during the dyeing. Because of the nature of the new chemical and
data on existing analogs, OTS concluded that short-term screening
tests would provide a reasonable indication of carcinogenic
potential. At OTS' request, the manufacturer suspended the
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review period and conducted carc 1 nogenic 1 ty screening tests on
the dye molecule ana a hydrolysis product, to which the PMN
substance might be converted in drinking water. In both cases,
the tests proved negative. The notice review period has now
recommenced; after its expiration the submitter will be free to
import the dye.
Second, OTS has found that negotiated §5(e) orders are the
most appropriate mechanisms for developing limited §5(e) orders,
which allow controlled production of the new chemcal. OTS1
first §5(e) orders were unilateral actions, banning the
manufacture of the new chemical pending the development of
data. In each of these cases, the manufacturer chose to forgo
production of the chemical rather than to conduct the tests
necessary for EPA to lift or modify the order. While UTS remains
committed to taking such actions when necessary, it also
recognizes that restricted production of a new chemical may be
appropriate, pending the development of data necessary to
evaluate uncontrolled uses. In these cases, §5(e) orders are
often best developed through negotiation with the submitter,
leading to a binding consent order. In many cases, the notice
review period is suspended, allowing for a more reasoned pace in
developing the order.
An example of this approach is the §5(e) consent order OTS
recently negotiated with a major shale oil developer, who will
soon be producing this country's first commercial shale-derived
petroleum substitutes. This order, which was based on an
extensive OTS review of analytical and health and environmental
effects data provided by the developer, requires worker exposure
and waste disposal controls during production of the synthetic
crude oil. It also requires the developer to provide OTS the
r-suits of ongoing environmental ana chronic health effects
tests, and it reserves for OTS the right to regulate the
production or use of the synthetic crude oil further under its §5
authorities if the results of the tests raise concerns. In
addition, to add ess potential problems identified during PMN
review, the shale oil developer, the state of Colorado, EPA's
regional office, and EPA's Office of Research and Development
reached an agreement that ensures EPA participation in Colorado's
review of the developer's research and environmental monitoring
plans. This negotiated consent order illustrates the flexibility
ot §5 in addressing complex technical and regulatory issues, its
unique authority for ensuring the development of data on new
chemicals (and in this case, new industries), and OTS' commitment
discussed more fully in Chapters III and V of this report
to coordinate its work with other offices and regulatory
age ncles.
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At the same time, OTS is exploring ways in whicn it can more
effectively communicate the technical rationale for its decisions
on new chemicals. To the extent that OTS can articulate its
decisions and concerns, it can provide the chemical industry with
important insight into how the Agency has dealt with specific
issues, and it can promote greater public oversight of its new
chemical reviews.
Toward this end, OTS is developing a new chemicals Advisory
Circular system. The Office will periodically publish circulars
summarizing actions on specific categories of new chemicals or
describing specific decisions. For example, for certain
categories of new chemicals, OTS has generally imposed controls
pending completion of short-term carcinogenicity screens, if such
tests had not already been conducted. By stating this ract in an
Advisory Circular, the Agency will provide greater certainty on
its standards for action; this would be particularly useful for
companies submitting notices on chemicals within these
categorie s.
OTS will also use Advisory Circulars to announce decisions
or legal interpretations related to new chemicals review. In
response to specific requests, OTS frequently reaches decisions
on such questions as the applicability of PMN requirements to
certain substances, the line between research and development
(R&D) and non-R&D commercial activities, and the kind of data
appropriate for a test-marketing exemption application. These
decisions, however, are generally communicated only to the
company making the inquiry. By announcing such decisions in
Advisory Circulars and explaining their implications, OTS ill
provide important guidance to the public, and it vill .contribute
significantly to more consistent §5 submissions and a broader
awareness of the new chemicals program.
C. PMN Exemptions
As explained earlier, OTS1 PMN experience indicates that
many new chemicals are of relatively low concern, either because
of low exposure or low toxicity. Review of these substances is
often completed before the 90-day PMN period has ended. As a
result, OTS believes it is appropriate to exempt certain
categories of low risk chemicals from full 90-day PMN review,
reducing the reporting burden and allowing earlier
commercialization. Such relief should significantly promote new
chemical innovation without increasing risks to health and the
e nvironment.
EPA took a major step toward a broad exemption policy in
August 1982, when it proposed limited PMN exemptions for certain
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site-limited intermeaiates, low volume chemicals, and polymers --
categories of chemicals that have generally been of low concern
in the PMN process. The proposals would establish the basic
framework of OTS1 exemptions program, as outlined in the January
1982 "Priorities" document. Exempt chemicals would generally
undergo a shortened review and woula be subject to reduced
information requirements. Because of the diversity of chemicals
that could be produced unaer the exemption, however, EPA included
a series of safeguards in the rules. For example, certain types
of polymers -/ould be automatically excluded from the polymer
exemption, and low volume chemicals and site-limited
l ntei'mediates (produced at more than 1,000 kg/yr ) would undergo
review by an industry "qualified expert" and would be
automatically excluded from the exemption if the^ were possible
carcinogens or teratogens.
EPA is now developing final rules based on these proposals
In developing these rules, the Agency is considering technical
and policy comments <-rom industry and public interest groups, as
well as it own impact analyses and risk assessments. OTS
estimates that 36-49% of new chemicals would be potentially
eligible for at least one of these exemptions, assuming the final
rules follow the basic framework of the proposal. Because of the
restrictions built into the exemptions, however, many
manufacturers of potentially exempt chemicals may choose to
submit PMNs instead.
By reducing notice requirements for certain low volume
chemicals, site-limited intermediates, and polymers, these
exemptions would provide important relief for a broad range of
new chemicals. In the future, OTS expects exemption requests for
chemicals that would not be eligible tor the proposed exemptions,
or for which the exemption applicant is requesting greater
relief. The Office anticipates that these exemption requests
will be for narrowly focused categories of chemicals defined
either in terms of exposure or chemical class. Dependiny on the
category, the exemption might be from all PMN requirements, from
certain information requirements, from the full 9U-day review
period, or from other PMN requirements. Because the applicants
would be requesting greater relief than that provided in the
basic exemption framework proposed by EPA, OTS will place the
primary burden of defining and justifying the exemption on the
applicant. It will be up' to the applicant to:
o Specifically define the exemption category.
o Provide the necessary supporting data on toxicity,
exposure, and other factors.
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o Make the case, based on a risk assessment, that the exempt
chemicals */ill not present an unreasonable risk.
OTS, o£ course, has the final responsibility for identifying the
c tegory, defining the terms of the exemption, and making the
finding of no unreasonable risk. However, it must be the
responsibility of the exemption applicant to perform the basic
vork nece ssary to support an exempt ion.
In addition to issuing PMN exemptions under §5(n)(4), OTS
grants test-marketing exemptions under §5(h)(l). To grant a
test-marketing exemption, OTS must tind that the substance will
not present an unreasonable risk to human health or the
environment under test-marketing conditions. Exemptions must be
granted or denied in 45 days. OTS now places the burden on the
exemption applicant to provide sufficient information for the
Office to make the "no unreasonable risk" finding. Where the
information is insufficient, OTS will deny the exemption. In a
forthcoming Advisory Circular, OTS will specify the kinds of
information that are necessary. OTS also carefully scrutinizes
test-marketing exemption applications submitted at the same time
as PMN1s on the same chemical. Unless the applicant company can
clearly demonstrate that its test-marketing activities are
legitimately distinguished from subsequent commercialization and
that it is not simply shortening the PMN review period by 45
days, these applications will be denied.
D. Mew Chemicals Followup
In the January 1982 "Priorities" document, OTS announced its
commitment to developing an effective new chemicals followup
program. The rationale for the program remains valid: OTS1
review of new chemicals at the premanufacture stage generally
focuses on intended methods of manufacture and use described in
the PMN, and it is based on toxicity and exposure data that the
manufacturer has developed before commercialization. After a
chemical has been entered on the TSCA Inventory, however,
unrestricted commercialization is possible without further data
development or EPA review. For this reason, a credible followup
program is an essential element of OTS' new chemicals program.
Since the 1982 "Priorities" document, OTS has begun to
implement its followup program. New chemicals review now
includes a process for identifying followup candidates; a new
chemicaL SNUR has been proposed; and several other case-specific
followup rules are undergoing internal EPA review. OTS
anticipates that six new chemical SNUR1s and one followup §8(a)
rule will be proposed by the end of FY83 and that in the future
approximately 10 followup rules will be issued a year.
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In conducting this program, OTS has developed several
general principles, which are now guiding its followup
activities:
o The major advantage of SNUR1s is that OTS has the full
range of §5 authorities to regulate or require data on a
substance when a SNUR notice is received. They are an
appropriate followup mechanism where concerns are focused
on specific health effects and OTS has been able to
identify possible new uses or growth in the marketplace
likely to increase risk.
o SNUR's are frequently necessary in connection with §5(e)
orders, because the order applies only to the notice
submitt-r. The order can in effect be extenaed through a
SNUR to other manufacturers and to processors, who
otherwise could make or process the chemical without any
restrictions. As a result, OTS has adopted a policy of
issuing SNUR's together with §5(e) orders. The triggers
for reporting under the SNUR generally follow the terms of
the §5(e) order.*
o Where concerns are not focused, or where it is less clear
what the next step should be when followup data are
received, §8(a) rules are generally nore appropriate for
followup than are SNUR's.
OTS identifies candidates for followup action on the basis
of toxicity concerns and possible changes in exposure that could
1 ad to increased risk. Such changes in exposure include a wiae
range of situations. Several examples are:
o Change from industrial to consumer use. For example, one
proposed SNUR would require notification of EPA before two
PMN chemicals, which are intended for use in industrial
cleaners, are manufactured or processed for consumer
use. The chemicals are known to be eye irritants, and
they have a clear potential for use in consumer
products. However, they have not been tested for eye
irritation in consumer strength formulations.
*OTS is also exploring the possibility of a "me-too" SNUR that
would automatically subject all §5(e) chemicals to SNUR
requirements. This possible approach is discussed in the
Addendum.
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° Change in circumstances of use. A SNUR now under internal
EPA review would require notice before a specific PMN
chemical was used in me ta 1 */ork 1 ng fluids. 0T5 is
concerned about possible nitrosamine formation (ana
therefore carcinogenicity) if the PMN chemical is used in
metalworking fluids together with nicrosating agents.
o Change in formulation, such as change from liquid to
powder form. Another SNUR under development */ould require
notice before a specific PMN chemical was manufactured or
processed for use in powder form. OTb is concerned that
the chemical, which is a dye intermediate intended for use
as a wet solid, might have carcinogenic potential if
inhaled or ingested. Manufacture or processing of the
intermediate as a powder would significantly increase the
possibility of inhalation exposure.
OTS1 case-by-case approach to followup which is driven by
identifiable toxicity concerns and is generally focused on
specific new uses allows the Office to concentrate on
circumstances of legitimate concern without imposing broad or
burdensome reporting requirements on a wide range of chemicals.
The considerable resources needed to implement case-by-case new
chemical followup makes it difficult to develop more than a
relatively few followup rules a year (compared to the total
number of PMN's). However, because new chemicals tend to be
specialized and have limited potential for new uses, OTS believes
that its current projection of 10 case-by-case followup actions a
year (primarily significant new use rules) represents an
appropriate l>-vel of effort. At the same time, given the
inevitable uncertainties built into new chemicals review, OTS may
miss possible concerns that could develop as a result of che
commercialization of specific new chemicals. As a result, OTS
intends to supplement its current case-by-case followup program
with a broader approach.
To establish this broad-based program, OTS intends to issue
a general §8(a) rule requiring companies to submit followup
reports on new chemicals when the chemicals reach a given annual
production volume. The report would contain limited information
on production, exposure, and potential risk, such as estimated
future production volume, uses, and available health and
environmental effects data. Under one approach suggested
originally by the Chemical Manufacturers Association*
*CMA suggested this approach in its comments on the proposed PMN
rules and its 1981 report First Four Years of the Toxic
Substances Control Act. An alternative approach would be to
require automatic followup reporting only on selected categories
of new chemicals.
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reporting would be required for all new chemicals at the same
production volume (e.g., 50,000 kilograms a year), regardless of
the category of chemical. Alternatively, OTS is considering an
approach in which the production volume trigger would vary
depending on the chemical category. For example, the volume
trigger might be lower for typically low volume chemicals, such
as photographic chemicals or fragrances, and higher for typically
high volume chemicals, such as lubricant additives ana
surfactants. This approach would provide greater flexibility,
and it takes more direct advantage of UTS' experience in the PMN
prog ram.
Under either alternative, the §8(a) followup rule would
provide an important supplement to the current new chemicals
foLlowup program. OTS would be able to track new chemicals as
they developed commercially, and, in cases of concern, it would
be able to take steps to require data development or to regulate
specific chemicals before they were well established in the
marketplace. This would provide a general safety net, allowing
OTS to address potential new chemical concerns that were not
anticipated during PMN review. At the same time, OTb would set
the production volume triggers at a level at which the new
chemicals could support the costs of notification. Therefore,
the rule would impose little burden on industry. The- impact of
the rule would oe further limited because many new chemicals fail
commercially and relatively few would reach the production volume
t r lg g e r . *
The general §8(a) followup rule would also allow OTb to
evaluate submitter estimates in PMN's and OTS' own conclusions
during PMN review concerning likely production volume, future
uses, health and environmental effects, and similar questions.
The ability to conduct such an evaluation will lead directly to a
more effective new chemicals program.
*OTS now receives Commencement of Manufacture Notices on
approximately 55% of new chemicals within 2-3 years of PMN
submission. As a result, OTS believes that a significant
proportion of new chemicals do not enter commerce.
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CHAPTER III EXISTING CHEMICALS PROGRAM
A . Int roduc tion
Since publishing the January L982 "Priorities" aocument, OTS
has developed an integrated existing chemicals program, capaDle
both of identifying potential problems ana of oringing them to
resolution. This program is now firmly established, with several
initiatives underway anc a clear direction for the future.
In developing this program, OTS has faced the same practical
and technical difficulties that have hindered existing chemicals
regulation under TSCA in the past. The most important of these
are described below.
o Over 60,000 commercial chemical substances are potentially
subject to TSCA regulation. Many are known to be hazards,
potentially warranting some degree of control, while the
risks of others are poorly characterized. At the same
time, new health and environmental effects data are
continually being developed on commercial chemicals by
government, industry, and universities. The task of
identifying priority candidates for data development ano
regulation from this great number of chemicals could be
never-ending.
Technical issues raised during existing chemical
regulation can be extraordinarily complex. These issues
include the assessment of risk, the identification and
evaluation of appropriate control options, the
identification of substitutes, and the analysis of the
economic impact of possible controls (or of failure to
control). Consequently, rulemakings on existing chemicals
are often extremely complex and must be supported by
extensive technical analysis.
Because society frequently has a stake in the production
and use of existing chemicals expressed in profits to
industry, jobs for workers, and benefits to customers
regulatory controls on existing chemicals often have
considerable economic and social impact. Frequently, the
more serious the problem (e.g., because of widespread use
and exposure), the greater the impact of regulation.
There is considerable overlap between OTS1 authority to
regulate existing chemicals under TSCA and the authorities
of other federal and state agencies. Most identifiable
chemical hazards potentially addressed under TSCA fall at
least partially under other authorities as well. As a
result, it is often difficult to identify the proper role
for TSCA.
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Despite these difficulties, TSCA nevertheless gives EPA the
responsibility to address a broad spectrum of cnemical risks,
both to humans and the environment, and it provides EPA with an
opportunity to take the initiative in existing chemicals control.
o TSCA gives EPA authority, unique among regulatory
agencies, to gather existing data on chemical risks and to
require the chemical industry to test suostances of
concern. No otner regulatory agency, for example, can
require manufacturers to test general commercial cnemicals
for a full range of human health and environmental
e f fec ts .
o TSCA gives EPA unique flexibility in addressing chemical
risks. Not only does the Act provide a wide variety of
regulatory mechanisms; it gives EPA the autnonty to
address all phases of a chemical's lifecycle (e.g.,
manufacture, processing, distribution, use, and
disposal). Other authorities typically address specific
categories of chemicals, specific media (such as air or
water), or specific circumstances of exposure (such as
occupational risks).
o The authorities listed above, the coordination provisions
of §9, and the data-sharing provisions of §10 give EPA a
central role among federal agencies in coordinating
approaches to the assessment and control of commercial
chemicals.
OTS' current chemical control program aims at a reasoned and
flexible exercise of these authorities, adjusted to the realities
of existing chemicals. The major principles underlying this
program flow directly from the points listed above, as well as
from several years of experience in existing chemicals review.
o Broad-based priority-setting exercises, designed to
identify the "best" candidates for regulation out of the
universe of existing chemicals, can be counterproductive
if they divert resources away from clearly identified
problems.* Candidates for OTS action should be identified
primarily through basic TSCA mechanisms, such as §4 rules,
§8(e) notices, §21 petitions, and PMN review. In
'Priority setting exercises have an important role in identifying
substances for testing and in assigning resources to existing
chemical problems identified through TSCA mechanisms. This
activity is discussed in Chapter IV.
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addition, monitoring data are important in identifying
high-exposure chemicals as potential candidates for
regulation.
o Any eftective existing chemicals program must be committed
to resolving problems, not simply to identifying and
evaluating them. An appropriate response to a problem
might not always mean regulation; it could involve
nonregulatory approaches to risk reduction, referral to
another authority, or dropping from review. However, a
credible .xisting chemicals program cannot allow chemicals
to remain under active review indefinitely.
o In considering action uncer TSCA, OTS must oe flexible ano
creative. Because the level of OTS concerns, the nature
ot the evidence, and the impact of controls will vary,
actions will vary as well. They could range from
immediate control of imminent hazards under §7 or
regulatory action under §6 to circulars advising industry
and the public of potential risks. They might also
include joint action with other authorities.
o The program should address manageable risks; apparently
intractable problems should be addressed in smaller
segments. Rather than attempting to develop comprehensive
analyses of all the possible risks from a specific
chemical, OTS first should focus more narrowly on
particular effects and exposures of concern.
Because of the coordinating role assigned to EPA by TSCA
and because of OTS' responsibility to seek resolution of
problems identified through TSCA mechanisms, OTS should
promote cooperation with other regulatory agencies and
other parts of EPA. Where appropriate, OTS and other
agencies should take joint action to characterize or
control particular hazards.
Together, these principles define the basic objectives of
the current existing chemicals program: (1) to identify
potential risks through TSCA mechanisms; (2) to ensure the
development of data adequate to assess those risks; (3) to ensure
that these risks are addressed under the appropriate regulatory
authority; and (4) where that authority is TSCA, to ensure that
appropriate action is taken. OTS' approach to achieving these
objectives, both now and in the near future, is discussed in the
sections below.
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B. Existing Chemicals Regulation
1. Identification of Regulatory Canaiaates
One of the major problems with the existing chemicals
program in the early years of TSCA was the absence of a
coordinated process for identifying and characteriziny potential
risks, selecting those that warranted OTS control, and bringing
specific issues to resolution. There was no Office-wice system
for selecting candidates for review, and specific chemicals often
underwent long-term assessment with no regulatory (or
nonregulatory) outcome in sight.
OTS addressed these issues in an October 1982 report
supplementing the 1982 "Priorities" document. In this report,
OTS laid out principles for selecting regulatory candidates:
attention goes to chemicals or categories of chemicals (1) on
which test data have been received under §4; (2) which are the
subject of §8(e) substantial risk notices; (3) on which test data
have been received from such sources as the National Toxicology
Program or §21 petitions; or (4) which have consistently raised
concerns during PMN review. The report also recommended the
establishment of a task force to implement a process not only for
selecting chemicals for action, but also for initiating action.
In response to these recommendations, OTS established an
Existing Chemicals Task Force in the tall of 1982. The Task
Force to date has conducted (or is now conducting) reviews of
60 substances, identified through the mechanisms above. About
one-fourth of these substances have been dropped from active
review (e.g., because data needed for a full assessment are
currently under development, because other authorities are
addressing the risks, or because risks do not warrant control);
at the same time, about two-thirds are targeted for further
analysis and preliminary decisions within twelve months. Five
have already moved into regulatory development. Recent
regulatory actions emerging from this process include an Advance
Notice of Proposed Rulemaking (ANPR) for MBOCA (4,4'-methylenebis
(2-chlorobenzeneamine)) and a §4(f) "significant risk"
designation for MDA (4,4'-methylene dianiline). Within the next
six months, OTS anticipates three to five additional actions.
2. Existing Chemical Control
The scope of OTS1s chemical control program and the nature
of control options now under consideration are best illustrated
by examples of current activities:
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OTS nas recently issued an ANPR on MBOCA, a curing agent
usee in plastics which has seen snown to be carcinogenic
in several species of animals. Although the chemical is
not now manufactured in the United States, two firms are
considering domestic manufacture, and it is imported at
1-3.5 million pounds per year. The primary risks from
MBOCA appear to be to plastics formulators, generally
working in small establishments exempt from Occupational
Safety and Health Administration (OSHA) inspections.
There is no ObHA standard for this cnemical, ano no otner
federal authority is directly addressing these risks. As
a result, after consulting with OSHA, EPA has issued an
ANPR suggesting a range of regulatory options, includiny a
ban of certain uses of M30CA. The ANPR also asks the
public to provide information and recommend alternative
approaches. The reason for OTb action on this chemical,
which is primarily a workplace concern, is TSCA's unique
authority and the absence of current OSHA activities.
OTS has designated MDA for priority review under §4(f) and
is considering the possibility of joint regulatory action
with OSHA. MDA, a high-production volume chemical used
primarily as an intermediate, was designated for §4
testing consideration by the Interagency Testing Committee
(ITC).* The ITC expressed concern for a range of
potential effects. However, a recent test conducted by
the National Toxicology Program already indicates serious
carcinogenic potential; therefore, OTS has initiated
priority review of the chemical under §4(f).** Because
MDA risks are primarily a workplace issue, OTS is
coordinating its action with OSHA. Depending on the
nature of subsequent activity (for example, if the best
alternative is to set workplace exposure levels), it may
be appropriate for OSHA to take the lead. In any case,
the §4(f) mechanism has been critical in ensuring prompt
regulatory attention to this potential hazard.
"The role of the TSCA Interagency Testing Committee in
designating candidates for §4 testing consideration is discussed
in the next section of this report.
**Section 4(f) requires that, upon receipt of data indicating
that there may be a reasonable basis to conclude that a chemical
substance presents or will present a significant risk of serious
or widespread harm to humans from cancer, gene mutations, or both
defects, the Administrator shall within 180 days, initiate
appropriate aciton under §§5, 6 or 7 to prevent or reduce the
risk, or publish a finding in the Federal Register that the risk
is not unreasonable.
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o Asbestos has been the subject of OTS activities since the
oarly years of the program. Recently, however, OTb has
taken important steps toward consolidating its efforts
toward asbestos and ensuring a coordinated approach by trie
various regulatory authorities concerned with this
material. These steps induce:
- Issuing a final §6 rule (in May 1982) requiring
inspection of public and private elementary and
secondary schools for friable asbestos-containing
materials. The compliance date for this rule was June
1983. EPA Regional Offices are providing technical
assistance to school districts in conducting
inspections. In July 1983, OTS will begin a survey of
local education agencies responsible for compliance to
determine the rule's effectiveness.
- Publication, together with the Consumer Product Safety
Commission (CPSC), of an Asbestos in Homes Booklet,
providing guidance for detecting and dealing with
asbestos in homes. This and similar efforts at public
outreach are discussed in Chapter V oc this report.
- The establishment of an interagency Federal Asbestos
Task Force to coordinate federal efforts concerning
asbestos. The Task Force, vhich vas established last
year, is chaired by OTS, and includes representatives
from OSHA and CPSC. During the next year, OTS will be
working with the Task Force to coordinate asbestos
control.
- To support the Federal Asbestos Task Force, OTS issued
in July 1982 a §8(a) reporting rule requiring
information on major aspects of asbestos manufacturing,
processing, and disposal. This information is now
coming into the Agency; both CPSC and OSHA have received
TSCA confidential business information clearance and
have access to information appropriate to their
authority. In addition, summaries of the information
will be available to the public.*
In connection with these activities, OTS is now developing
an overall regulatory strategy for asbestos, which will
identify specific asbestos uses for possible regulatory
action or other controls. This strategy will be completed
by the summer of 1983.
*Intormation-shanng and the problems of confidential business
information are discussed in Chapter V.
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In 1979, OTS issued rules implementing the TSCA §6
provision banning polyc hlor mated biphenyls (PCB's). In
October 1980, the U.S. Court of Appeals for the District
of Columbia ordered EPA to revise two aspects of these
rules: one defined electrical uses of PCB's as "totally
enclosed," excluding them from the ban; the other excluded
from regulation PCB1s incidentally generated at 50 ppm or
less. In response to the court decision, OTS has issued
during the past year a rule governing the use of PCB's in
electrical equipment anc a rule addressing one aspect of
the 50 ppm issue under this rule, processes that can be
characterized as closed and controlled waste manufacturing
processes have been excluded from the 1979 ban. OTS is
now developing a rule addressing the remaining issues
raised by the 50 ppm regulatory cutoff. The Agency
recently received a proposed approach for dealing with
these issues, prepared jointly by the Chemical
Manufacturers Association, the Natural Resources Defense
Council, and the Environmental Defense Fund. A proposed
rule is scheduled for December 1983.
o Chlorinated naphthalenes and chlorinated terphenyl,
organic chemicals with a wide range of potential uses,
were designated for §4 testing consideration by the ITC
because of possible carcinogenicity and other concerns.
However, the use of chlorinated naphthalenes has declined
to low levels, while chlorinated terphenyl is no longer
used in the United states. As a result, OTS concluded
that test rules were not justified at this point. But, to
ensure against renewed production or expansion of use
without adequate data, the Office is proposing to monitor
these chemicals through followup rules. Chlorinated
napthalenes, which are now imported and used in relatively
small amounts, are the subject of a proposed SNUR;
chlorinated terphenyl, which is not now produced or
imported, is the subject of a proposed §8 (a) reporting
rule.
These examples of ongoing activities illustrate the
flexibility TSCA provides OTS in choosing among regulatory
options. The full range of options now considered by OTS and the
advantages of each are summarized more directly below:
o Section 6 regulatory action. As illustrated by OTS
asbestos activities, this authority provides the Agency
considerable flexibility. In the future, OTS will use ^6
more effectively by moving promptly to publish ANPR's, as
it did in the case of MBOCA. The Office will issue ANPR's
when data indicate that regulation may be needed to reduce
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a potential unreasonable risk, but before the details of
the regulatory approach have been worked out. Earlier
publication of ANPR's will alert the public to a potential
concern, encourage public participation, and speed up the
rulemaking process.
o Section 4(f). Section §4(f). is designed to compel EPA's
priority attention to situations of significant risk of
"serious or wide spread harm." For this reason, OTS
believes that the threshold for action under this section
is higher than simply a potential for "unreasonable
risk." A §4(f) situation should be one that is an
especially serious one, because of either the number of
persons potentially at risk or the likelihood of injury.
MDA was designated for priority review under §4(f) in
major part because of its carcinogenic potential and the
lack of any workplace regulations.
o Information gathering under §8 or control under
§5(a)(2 ) . Section 8(a) reporting requirements and
§5(a)(2) significant new use rules are generally most
appropriate for existing chemicals when they are used to
complement broader regulatory activities, such as UTS'
test rules program and its investigations of asbestos, or
to monitor the development of potential risks such as
chlorinated naphthalenes or chlorinated terphenyl that
do not warrant immediate action. These sections provide
OTS flexible information-gathering and regulatory
authorities that are an important complement to its other
authorities. Section 8(a) is useful for more general
information gathering or to provide data in support of
specific regulatory actions, while §5(a)(2) allows EPA to
prevent increases in exposure to chemicals of concern
before necessary data can be developed.
o Referral to other agencies. Many potential risks
identified through TSCA may be more effectively controlled
by other agencies. OTS will defer to these agencies and
offices when their statutory authority is sufficient to
control the risks adequately and when they are actively
addressing the risks. (However, as explained above, OTS
intends to act jointly with other agencies when TSCA's
regulatory authority uniquely protects against risks).
o Voluntary approaches. The 1982 "Priorities" document gave
high priority to voluntary approaches to existing chemical
control. While OTS continues to believe that voluntary
actions are useful in specific circumstances, it has not
yet found it appropriate to negotiate "voluntary controls"
with a specific company or trade organization.
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o Risk Management Advisories. In one area, OTS sees
considerable promise in a "voluntary" approach: the
Office will be publishing Risk Management Advisories
focusea on specific problems associated with specific
substances. These Advisories will describe toxic effects
of concern, routes of exposure, ana alternative methods of
reducing risks; they will be published after consultation
with interested parties, which could include industry,
public interest groups, or other agencies. Risk
Management Advisories, OTS anticipates, will oe an
important nonregulatory endpoint of the existing chemicals
process; they will be particularly useful where an
increased awareness of risk is likely to lead to
meaningful precautions. Risk Management Advisories will
not be a substitute for rulemaking; in fact, they may in
certain cases be issued in connection with rulemaking
activities for example, together with an ANPR in
order to alert industry and the public as soon as possible
to potential risks.
In the coming year, OTS will assign high priority to
reviewing chemicals identified by TSCA mechanisms under the
existing chemicals process and, where appropriate, will promptly
initiate action under the regulatory options discussed above. As
noted earlier, one of the most important triggers for action will
be data received under §4 test rules. Within the next few years,
significant amounts of these data will become available.
C. Section 4 Testing Program
Section 4(a) of TSCA authorizes EPA to issue rules requiring
chemical manufacturers or processors to test specific chemicals,
categories of chemicals, or mixtures for potential health ana
environmental effects. To require testing, EPA must find that
(1) the substance may present an unreasonable risk of injury to
health or the environment, or it is or will be produced in
substantial quantities and there is or may be substantial
environmental release or significant or substantial human
exposure; (2) data ana experience are insufficient to determine
the potential effects of the manufacture, processing,
distribution, use, or disposal of the substance; and (3) testing
is necessary to develop data concerning these potential effects.
TSCA also establishes a priority-setting mechanism to ensure
that potential hazards are addressed expeditiously under this
authority. Section 4(e) sets up an Interagency Testing Committee
(ITC), composed of representatives from the major federal
agencies concerned with health and the environment. This
committee recommends substances to EPA for priority consideration
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for testing under §4(a). The ITC may also "designate" priority
chemicals not to exceed 50 at any one time. EPA must respond
within 12 months to a chemical's designation, either by
initiating rulemaking unaer §4 or oy publishing in the Federal
Register its reasons for not initiating a rulemaking.
Through its twelfth report, issued in May 1983, the ITC has
designated 69 individual chemicals or categories of chemicals for
testing consideration.* Two additional categories have been
recommended without designation for response within 12 months.
EPA's testing program initially got off to a slow start, as the
Agency failed to meet three statutory deadlines with responses
that the court considered to be legally sufficient. This lack of
action led to a lawsuit in 1979, which resulted in a court
schedule for Agency responses to the 37 backlogged ITC
designations.
Since imposition of the court-ordered schedule in 1981, the
main priority of OTS' testing program has been to eliminate the
backlog within the court-oraered time periods and to respond to
additional ITC designations within the one-year statutory
deadline. As a result, OTS has complied with the statutory
deadline for all new ITC designations, and has responded to the
required number of backlogged designations in 1981 ana 1982. The
Office anticipates eliminating the backlog by December 31, 1983,
as required by the court. In total, by the end of 1983, OTS will
have responded to recommendations on 63 designated chemicals or
chemical categories and one nondesignated category.
In responding to ITC designations, OTS places considerable
importance on developing needed test data rapidly, so that
potential risks can be identified as soon as possible. As a
result, where appropriate, the Office will accept negotiated
testing programs submitted by manufacturers or industrial
consortia, rather than proposing test rules to obtain these
data. This is often in industry's interest as well as EPA's
because, according to industry, ITC designations can place
chemicals at a competitive disadvantage. Therefore, industry has
an incentive to complete testing and to clear up any
uncertainties as soon as possible. EPA believes that negotiated
testing programs are in the public interest and are preferable to
rulemaking where they will provide the needed test data
substantially sooner than could be accomplished through
rulemak l ng .
*One category, alkyltin compounds, was withdrawn by the ITC.
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Generally, as much information is produced unaer negotiated
agreements as would oe required in a test rule. Furthermore,
negotiated agreements provide greater flexibility than test:
rules, particularly in facilitating tiered testing. In a rule,
tiered testing is feasible only where automatic triggers for
followup testing can be defined ahead of time -- as in the case
of mutagenicity testing. Tiered schemes that rely on judgment
often do not lend themselves to test rules, because criteria for
further testing cannot be readily written into the rule
language. Consequently, it is necessary in :hese circumstances
to require the full range of testing in the initial rule.
Negotiated agreements, however, are flexible enough to allow
tiered schemes that depend on judgment by providing for interim
review of data and staged decision points.
Negotiated test agreements with industry have been
criticized by some public interest groups as unenforceable and as
excluding outside parties from EPA's decisionmaking process.
While OTS agrees that negotiated agreements are legally
unenforceable, the Office believes these agreements are generally
entered into in good faith. Furthermore, the threat of
rulemaking under §4 will ensure that the chemical industry
adheres to its agreements. 0Tb will learn of departures from the
agreements, because tests conducted under negotiated agreements,
as well as tests conducted under §4 rules, will oe monitored
through 0Tb' laboratory audits, and because periodic reports are
required in the negotiated agreements.* If the Office has reason
to believe that industry has not acted in good faith, it will
promptly initiate §4 rulemaking.
OTS also takes steps to ensure an adequate opportunity for
public participation in negotiated testing agreements. There is
an opportunity for written comment, and two public meetings are
held on each ITC chemical before OTS develops a response to the
ITC recommendation. Furthermore, lr a negotiated approach is
chosen, public interest groups are given an opportunity for
updates and discussions on the status of negotiations. As a
result of these procedures, outside groups actually have a
greater opportunity to participate in the Agency's decisionmaking
in negotiated agreements then they do in rulemaking.
Overall, negotiated test agreements have achieved their
major purpose to speed up the development of data on ITC
chemicals. OTS estimated earlier that on average 1 to 1.5 years
may be saved through negotiation. This is proving to be the
*The laboratory audit program is discussed in Chapter IV.
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case. In 1982, the Office received 95 testing studies from
negotiated agreements; unoer test rules, these studies prooaDl/
would not have been completed until 1984. OTb anticipates that
another 195 studies will oe received by the end of 1983 and 250
in 1984, all from negotiated agreements. Where tney indicate
adverse effects, these data will oe used oy the existing
chemicals program to determine the need for additional data or
regulatory action.
OTS, however, has also found that certain chemicals are not
appropriate for negotiation. For example, where there are
numerous manufacturers of a chemical, testing needs are
extensive, or complex issues prevent agreement, rulemaking is
often necessary. In responding to the original court scnedule
for addressing the backlog, OTS first picked those cnemicals tnat
could be most rapidly addressed. Many of these, lent themselves
to negotiation; however, many of the remaining chemicals do
not. Therefore, the percentage of chemicals on the backlog list
that go into rulemaking is likely to increase significantly. In
1982, OTS proposed one test rule, negotiated ten testing
agreements, and decided that testing was not required on eight
chemicals or chemical categories. In the first half of 1983, OTS
has negotiated testing agreements for one ITC chemical, proposed
test rules for six chemicals or chemical categories, and decided
that further testing is not required on one chemical.
As the backlog of ITC chemicals is eliminated, OTS will
develop test rules on substances not designated oy tne ITC. For
example, these might include substances snown to nave sigmncant
human exposure by OTS1 monitoring activities or classes of
substances identified as potential concerns in the PMN review
process. OTS anticipates that it will begin its first §4 efforts
on a non-ITC cnemical witmn tne next year, with proposal in
FY85 .
D. Monitoring Chemical Exposure
To complement the §4 testing program and to support its
overall existing chemicals program, OTS conducts a wide range of
chemical monitoring activities. These activities are
particularly important because accurate data on chemical exposure
are needed to support regulatory decisionmaking, and because
information on exposure to existing chemicals, where available,
is often unreliable or difficult to interpret. OTS' general
monitoring activities are designed to address these problems by
providing actual levels of human and environmental exposure to
specific compounds. The major goals of these activities are:
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o To support the assessment a no possiQle regulation of
specific cneraicals oy providing human ana environmental
exposure data, which are necessary to estimate the
magnitude of risk and evaluate the effectiveness of
different control measures.
o To identify potential candidates for testing under §4,
control under §6, or other regulatory action (for example,
chemicals may be appropriate for §4 or §6 action if they
are found in high concentrations or are widespread in the
environment or in human body fluids or tissue).
o To establish baseline levels of human exposure to
chemicals of concern, so that OTS can measure trends over
tine and identify populations, geographic areas, or other
groupings for which exposure is higher than the baseline
level.
One of the most important direct contributions of these
activities is to provide ongoing support to long-term OTS
projects, such as the Oftice's work on asbestos and PCB1s.
Examples of this support are described below.
o OTS recently conducted an asbestos monitoring study in one
school district. This study was designed to indicate the
levels of asbestos in school buildings anc to evaluate a
formula that had been developed for determining when
asbestos-containing materials should be removed from
schools. This effort has led to the identification of an
important factor to be considered in removal decisions,
and it has served as a basis for OTS technical guidance to
schools in monitoring for asbestos and in removing
asoestos-containing materials.
o OTS will be conducting a similar survey in "habitable"
public buildings, such as hospitals, libraries, and
housing projects. This one-year project will provide
information critical to assessing risks associated with
the presence of asbestos-containing materials in public
buildings. As a result, this work may directly support
future OTS activities.
o OTS will evaluate permit applications, submitted in
accordance with TSCA §6 PCB regulations, to dispose of
PCB's by incineration or other means. OTS' review of
these applications will address the adequacy of the
applicants' monitoring plans for determining that the
PCB' s are in fact destroyed and that they are converted to
harmless materials.
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Monitonng activities and exposure analyses have also been
thoroughly integrated into other aspects of OTS ' existing
chemicals program particularly the review of regulatory
candidates and the identification of control options. As part or
the existing chemicals program, OTS has developed mechanisms that
allow prompt, focused monitoring support for existing chemicals
review. These mechanisms ensure the development of exposure data
needed to support regulatory decisionmaking. Two examples
illustrate this support:
o OTS is now reviewing the risks posea by a specific class
of paint additives. Monitoring activities in connection
with this review involve (1) the identification of paints
on the market that contain these additives, ana (2)
experimental work to determine the levels of exposure that
can be expected to result from commercial or consumer use
of these paints. This information is essential in
estimating the magnitude of risk and the feasibility of
different control options.
o OTS is also reviewing risks that may be associated with
the use of reclaimed industrial solvents in general
commercial and consumer products. At present, no
regulatory authority is addressing possible risks to
consumers and commercial users from these solvents,
although the solvents may be hazardous themselves and they
may contain toxic impurities. To get a clearer picture of
the risks, OTS is now conducting a pilot study to
determine the nature of the recycled solvents market,
collect samples of products containing selected high-
product ion-volume solvents, and analyze these samples for
impurities. The information will be necessary to define
the extent of the problem, identify possible control
strategies, and support regulatory decisions.
In addition to these ad hoc projects, which support specific
existing chemical assessments, OTS is conducting more broaa-based
studies to identify potential regulatory candidates and to define
a baseline of exposure to specific chemicals of concern. The
most important of these projects are described below:
o As part of the National Human Adipose Tissue Survey, OTS
is monitoring the level of PCB's in human fatty tissue.
This survey, which has been underway since 1967, has
provided a direct measure of the human body buraen of
PCB1s since 1972. Results recently published by OTS
indicate that the percentage of the U.S. population having
higher levels of PCB's has decreased since a high point
was reached in 1977. This trend reflects the banning of
PCB's under TSCA in 1976.
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o OTS is beginning a one-year monitoring project in which
human tissue samples will oe analyzes for a broaa spectrum
of chemical substances. The project, which involves a
representative sampling of the U.S. population, stratified
geographically and demographically, will allow OTS to
identify chemicals with high or widespread body burdens in
humans. This information will be used in defining future
TSCA ambient monitoring programs ana in identifying
candidates for testing under §4 or regulatory controls
under other authorities.
The major significance of the monitoring activities
illustrated above is that they are closely integrated with the
Office's existing chemicals program and that they provide direct
support to OTS' regulatory agenda. Monitoring by EPA
traditionally has been aimed at measuring the degree of
compliance with specific regulations for example, determining
whether certain process emissions meet specific standards. OTS1
monitoring program, however, is designed more to assist in
identifying risks and developing control measures than it is to
determine compliance or noncompliance. This focus is reflected
in the direct impact of OTS monitoring activities on the existing
chemicals program. Within the next year, these activities will
contribute information important in the identification of
candidates both for data development and for control, and they
vill provide exposure information necessary in onging OTS
rev lews.
E. Coordination of New and Existing Chemicals Programs
One of the major operating assumptions of TSCA is that new
and existing chemicals warrant separate treatment. The
difficulties and controversies associated with controlling
existing chemicals should not stand in the way of a strong Agency
commitment to preventing new hazards from occurring regardless
of whether they appear to be less serious than some existing
hazards. At the same time, however, OTS is taking steps to
ensure that its new and existing chemical programs are well
coordinated and that together they contribute to an integrated
program of chemical hazard identification and control.
Chapters II and III of this report have discussed several
places where OTS' new and existing chemical programs intersect.
OTS is committed to strengthening these points of intersection,
and it has now developed or will be developing in the near future
a number of mechanisms to promote a more unified overall
program. The most important of these mechanisms are described
b e 1 ow:
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Use of the PMN review process to identify chemicals for
review by the existing chemicals program. Certain
categories of chemicals have repeatedly raised some level
of concern in the PMN process, suggesting that there may
well be hazards associated with existing chemicals in
those categories. In several of these cases, the
categories have been referred to the existing chemicals
program for evaluation. In other cases, new chemicals
have not been regulated under §5 because their
introduction into commerce would oe likely to lead to a
net reduction of risk, since they would be used as
substitutes for potentially more hazardous existing
chemicals. In such cases, the existing substances may be
appropriate subjects for evaluation.
Use of generic assessments developed in the PMN process to
support existing chemicals review. As discussed in
Chapter II, OTS has developed generic assessment of
certain industries, classes of substances, routes ot
exposure, and other factors that have repeatedly raised
some level of concern in the PMN program. These
assessments have in turn proved useful in existing
cnemicals review.
o Use of physical-chemical estimation, SAR, and modeling
technlques developed for the PMN review process in
existing chemicals review. For example, these techniques
are useful in the initial evaluation of existing
substances identified as potential hazards through TSCA
mechanisms such as §8(e). Conversely, monitoring and
exposure data developed in connection with the existing
chemicals program are useful in estimating likely exposure
to new chemicals.
o Use of health and environmental effects data developed
under other TSCA authorities to support the review of
PM N ' s. OTS' evaluation of new chemicals depends in part
on a review of data on analogous chemicals. Data on
existing chemicals submitted to OTS in accordance with §4,
§8(d), and §8(e) among other authorities, are often useful
as analog data in new chemicals review. With the
development of SPHERE and other OTS data retrieval
systems, these data will become more readily available for
PMN review. (The development of these data systems is
aiscussed in Chapter IV.)
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o Use o£ the §5(a)(2) significant new ase authority to place
a_ l_imit on the growth of existing chemicals until aaectuate
data are developed or their safety is otherwise ensurea .
One example of this approach is the proposed SNLfR on
chlorinated naphthalenes. Under the SNUR, any production
in the U.S. and any importation above 100,000 Ib/yr would
be subject to EPA review under the full authorities of §5.
Therefore, the SNUR would in effect change the status or
chlorinated naphthalenes from existing to new chemicals.
UTS will explore similar uses of the SNUR autnonti in the
future.
Through these mechanisms, OTS has taken significant steps
within the last year toward coordinating its new and existing
chemicals programs. In the future, OTS will continue to
emphasize the use of these and similar mechanisms to ensure an
integrated program.
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CHAPTER IV TECHNICAL DEVELOPMENTS
A. Introduction
The effective implementation of TSCA depends, ultimately, on
the quality of the science that supports regulatory decisions.
Recognizing this fact, Congress provided EPA ^ith specific
responsibility under TSCA §10 to develop methodologies, collect
and disseminate data, and conduct research to support its
activities; the purposes of the Act, the House Report stated in
describing §10, would be "ennanced Dy allowing the development ot
proper tools" {TSCA Legislative History, pp. 699-700).
Developing these tools, including computerized data bases,
environmental fate models, SAR techniques, standardized test
methodologies, and quality assurance procedures, has been a
priority of OTS. The Office will commit major resources toward
these activities during the next year and will continue to
integrate them into the decisionmaking process.
B. Data System Development
In assessing risks ot ooth new and existing chemicals, OTS
depends on the ready availability of a wide range of data,
including data on physicai-chemical properties, health and
environmental effects, and chemical exposure. The standard
bibliographical and scientific data bases are an invaluable
source of references, abstracts, and data concerning chemical
risks; in its aay-to-day operations, however, OTS nas found that
existing systems have important limitations for some of its
purposes. As a result, OTS is taking steps to supplement these
systems with its own data bases, which are designed to (1)
provide enhanced access to data previously submitted to OTS under
TSCA or obtained in the course of an OTS analysis, and (2)
provide access to critical scientific and technical data.
Ready access to data extracted from the literature, as
opposed to literature references or abstracts, is particularly
important for OTS, given the nature of its programs. In the PMN
program, for example, OTS must make rapid decisions (usually
within two weeks) concerning which of the approximately 100 new
chemicals reported every month warrant more detailed review, and
which can be dropped from further consideration. To make these
judgments, OTS looks not only at the data submitted on the
chemical itself, Dut also at available data on analogous
cnemicals. It is essential that data on analogs be readily
retrievable and, to the extent possible, that enough information
be provided for the reviewer to understand the validity of these
data. Standard bibliographical data bases often do not allow
this, because of the time required to obtain the references, to
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extract the data, ana in some cases to determine their relevance
to the review. Similarly, OTb oenefics greatly trora reaay access
to oata in its existing chemicals program, both in conducting
preliminary assessments of data submissions -- for example, under
§8(e) and in selecting potential candidates for testing or
regulation from among the large number of existing chemicals.
Finally, access on computerized data bases to a wide variety or
Q-ta facilitates the development ana validation of bAR.
For these reasons, OTS has made a major commitment to
developing computerized and other data s^ stems that are desiynea
to support its own regulatory programs. The Office's focus has
been primarily on data submitted under TbCA or obtainea in the
course of OTS reviews in other words, the goal has been to
develop an institutional memory although OTb has also devotea
significant resources to developing data bases on specific areas
ot OTS concern, such as genetic" toxicity, aquatic toxicity, and
chemical fate, particularly where available data are difficult to
obtain or are not well validated. Several representative data
bases under development by OTS are discussed below:
o TDIS {Technical Data Indexing System) is an automated PMN
file, containing data from PMN ' s such as chemical
laentity, production volume estimates, use categories, and
kinds of test data submitted. The system, ^hich contains
almost entirely confidential information, is designea to
allow quick access to previous PMN reviews and a ready
overview of the PMN program. It is now in use within OTb
and is constantly being updated- OTS has also instituted
a project to upgrade TDIS by incluaing key findings and
summaries of oast reviews.
o GENE-TOX contains results of short-term mutagenic and
related assays on about 2,700 chemicals reported in the
scientific literature. The major significance of this
system is that the data it contains have been validated by
national experts as part of OTS1 Gene-Tox Program,
described more fully in Section F below.
o AQLFIRE covers world literature on the toxicity of
chemicals to freshwater and marine organisms. ThLS data
base, which has been under development since 1981,
currently contains over 30,000 studies on 2,700 chemicals
and 1,800 organisms. The project, which is a joint effort
of OTS and the EPA Environmental Research Laboratory in
Duluth, Minnesota, represents an OTS initiative in an area
poorly covered by existing data bases, but of critical
importance to OTS analyses.
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The SPHERE system, which is currently under development by
OTS, integrates a diverse range of UTS and other
scientific data bases, including GENE-TOX and AQUIRE. It
will contain data on physical-chemical properties, health
effects, environmental effects, and environmental fate,
derived either from submissions to OTS or from the
literature. In addition to final test results, the system
will include information on test protocols and other
details, so that the applicability and usefulness of the
results can be quickly assessed. At the moment, SPHERE is
being developed as an ln-house tool to assist in PMN ana
other reviews. However, because of its breadth and its
inclusion of aata not readily available elsewhere, it will
be an invaluable tool to outside users. Several SPHERE
subfiles will soon be available through the NIH/EPA
Chemical Information System.
A Global Indexing System has been developed by OTS to
allow quick access to various OTS document collections.
The system now covers the OTS public file records (17,000
documents); other collections, such as unpublished health
and safety studies on ITC chemicals submitted under §8(d),
will soon be adaed. While individual collections dirfer
in content and physical state, they do have common traits
and information that can be categorized at a level above
their primary use. The data elements in the Global
Indexing System were developed to capture this common
information. The data elements, which are primarily
bibliographic, include document title, author, date,
publication title, chemical name, CAS number, document ID
number, and microfiche number.
o An Asbestos Information System has been established for
information submitted to EPA under the §8(a) asbestos
reporting rule, discussed in Chapter III. This data base
a '.lows EPA to analyze the volume of asbestos processed,
the use of the materials produced, the companies that are
producing asbestos-containing materials, and similar
questions. The data base is confidential, but
nonconfidential aggregations of data will be developed.
(For a discussion of confidentiality, see Chapter V.)
o OTS has also developed a data base of information received
under its §8(a) preliminary assessment information rule.
Information can be retrieved through a number ot data
elements, such as production volume, manufacturer,
customer uses and products, and worker exposure. Like the
Asbestos Information System, this data base is
confidential, but aggegrates will be made available to the
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public. This data base will be expanded in the future to
include processor reports as well as data collecteo on
chemicals added in the future to tne §8(a) rule.
These systems generally illustrate the nature of the data
bases now under development at OTS, and they indicate several
general principles now guiding OTS1 work: (1) the Office's first
priority, at this point, is to enter TSCA data into its own
systems, in order to develop an institutional memory; (2) as a
second priority, UTS will enter aata on areas of specific concern
that are inadequately represented in existing aata bases; (3) it
is important to have rapid ana direct access to data, as -veil as
references and abstracts; ana (4) it is important for sufficient
information to be provided so that data can be interpreted ana
used appropriately. These principles will continue to guiae OTS
activities in the future.
C. Models and Analytical Tools
To complement these data ba
data are missing, OTS is using a
on chemical structure, to estima
and computer models to evaluate
exposure, environmental effects,
ses and to provide yuiaance where
broad range of techniques, based
te physical-chemical properties
potential environmental fate and
and health risks.
OTS estimation techniques for calculating basic physical-
chemical properties were developed during the last few years
under a contract jointly funded by OTS and the Department of the
Army. 'within the last year, OTS has developed or made internally
available two programs, CHEMEST and CLOGP, which computerize
techniques for predicting water solubility, boiling point, vapor
pressure, soil absorption coefficient, bloconcentration factor,
octanol/water partition coefficient, and other properties. These
properties are critical in estimating potential human and
environmental exposure, as well as in some aspects of health and
ecological effects analysis. As discussed in Chapter II, the
estimation techniques are not a complete substitute for actual
data; however, they are useful in pointing to areas of potential
concern requiring further assessment.
The techniques are now being upgraded to include additional
properties, and an extensive investigation of the accuracy of the
predictions and limits of applicability is being conducted. In
addition, because the use of these techniques is limited to
classes of compounds for which structure-activity data are
available, several projects are now underway to expand these
techniques to include additional chemical classes. These
activities are discussed briefly in Section D below.
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In addition to estimation techniques, OTS has developed a
number of computer models to estimate environmental fate and
population exposures. These models can be used to evaluate air,
land, surface water, or groundwater releases. They are
applicable to both new and existing chemical reviews, both as
screening tools to focus further assessment and as evaluation
tools to provide exposure data for quantitative risk
assessments. The environmental fate and exposure models have
been integrated in a computer system, the Graphical Exposure
Modeling System (GEMS), making them more accessible to OTS
users. GEMS is a set of interrelated computer programs
(including CHEMEST and CLOGP) allowing OTS to estimate physical-
chemical properties based on chemical structure; to predict
environmental fate and exposure through environmental simulation
models applicable to air, water, and land release; and to develop
quantitative or qualitative exposure estimates through a
population data retrieval program. The system includes
statistical analysis as well as mapping and graphics display
capabilities to allow the presentation of modeling results in the
most useful form possible.
For use in conjunction with derived or observed exposures
and observed effects data, primarily in the health arena, OTS has
acquired or developed a variety of computerized health risk
assessment tools. These tools have been used to date primarily
with cancer data, but expansion and use with other adverse health
effects data are anticipated. Capabilities encompass models
designed for use with dichotomous or prevalence data (MULTI80G,
GLOBAL 83, MANTELAN, ONE HIT MD) and with incicence or so-called
"time-to-occurrence" data (RANK TIME, MRS.T). These models
permit OTS to make educated projections about the potential
health risks of substances at exposures below those that have
been studied.
D. SAR Development and Validation
As discussed in the section above and in Chapter II, SAR
techniques play an important role in OTS' implementation of TSCA
particularly in new chemicals review, where SAR has proved to
be a useful tool in identifying potential areas of concern. The
systematic use of SAR in estimating physical-chemical properties
and health and environmental effects, however, is a relatively
new technique still under development, and it has raised
significant controversy. OTS is now conducting or sponsoring a
series of projects to refine and validate its use of SAR; these
activities are essential in determining the level of confidence
that should be assigned to specific techniques and will lead to
significant expansion of the Office's present capabilities. OTS1
general activities in this area include:
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o Projects to expand ana validate the techniques for
estimating physical-chemical properties based on chemical
structure. These efforts include (1) refining current
capabilities through validation studies, (2) developing
techniques for estimating additional physical-chemical
properties, and (3) extending the techniques to categories
of chemicals not now covered. One of the most important
efforts is a joint project with the Umweltbundesamt of the
Federal Republic of Germany, which will be funding several
major refinements of the CHEMEST program in return for
access to that program and any future improvements to it.
o Projects to develop or refine SAR techniques for aquatic
and mammalian toxicity. For example, the Office of
Research and Development (ORD) laboratory in Duluth is
conducting several studies to support the development of
quantitative techniques to predict aquatic toxicity from
chemical structure. In addition, several OTS or ORD
projects are aimed at strengthening SAR capabilities for
selected classes of chemicals or selected classes of
chemicals or for selected effects.
o Reviews of available literature to refine SAR-based
judgments in specific areas. These reviews generally
focus on specific categories of concern (for example,
categories that repeatedly raise concern during PMN
review); routes of exposure of concern, such as dermal
absorption, to allow better predictions of likely doses;
and effects of concern, such as the comprehensive review
of literature on mutagenicity conducted under the OTS
Gene-Tox program.
o Projects to validate the use of SAR within OTS regulatory
programs. For example, OTS is designing an experimental
program to evaluate its use of SAR during new chemical
review. The basic approach would be to test a sample of
PMN chemicals for specific physical-chemical properties
and health and environmental effects and to compare these
test results with OTS estimations. This project, if the
design proves feasible, would provide important
information on the use of SAR as part of PMN review.
To support this general activity, OTS technical staff with
program responsibility have been meeting with ORD researchers to
direct further research on SAR development and validation. Both
OTS and ORD will commit significant resources to defining and
carrying out this research over the next year; the results will
be directly applicable to OTS' review of new chemicals, and will
provide important guidelines for selecting testing or regulatory
candidates from existing chemicals.
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E. Priority Setting Methods
OTS has, along rfith other groups such as the ITC, encouraged
and sponsored the development of chemical scoring and priority
setting systems to aid in selecting chemicals for further
evaluation from among large numbers of candidates. One such tool
is being evaluated for use with existing chemicals at preliminary
stages of assessment. The system depends on experts to assign
scores to chemicals oased on known or suspect health or
environmental effects and exposure potential. The scores are
intended to assist in deciding which chemicals in a set of
identified possible chemical problems present the greatest
concern regarding potential risk. If shown to be consistent and
valid, this approach may be used in assigning resources to
existing chemical problems Drought to OTS' attention through
§8(e) notices of substantial risk, §4 test data, and other
current testing data.
F. Quality of Data
Regardless of the strength of OTS' analytical tools anci the
scope of its data bases, the quality of its decisionmaking will
rest finally on the integrity of the data being analyzed or
retrieved. OTS, as a result, has committed considerable
resources since the passage of TSCA to ensuring tne quality of
data developed or reviewed under the Act.
1. Test data
Frequently, available toxicity and environmental effects
data can be difficult to evaluate or compare with other data,
because of differences in test methods, inadequate statistics,
poor characterization of test substances, poor control of test
conditions, or similar problems. While data from such tests can
often provide important insights into the potential toxicity of a
substance, they may form a weak oasis for making regulatory
decisions. To address this problem, OTS at a minimum promotes
the inclusion of test method documentation in its data bases,
such as SPHERE, to allow users to evaluate the validity of test
results for their particular purposes. In addition, OTS is also
working with other national and international organizations to
ensure, to the greatest extent possible, the use of standardized
test procedures, leading to acceptable, reproducible data.
Several OTS activities illustrate the Office's continued
commitment in this area:
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o Testing guidelines. for several years, OTS has seen
engaged in a major effort to develop testing guidance
"protocols" for a wiae variety of health and environmental
effects. In August 1982, UTS puDiisneo 9b standardized
guidelines for conducting basic healch effects,
environmental effects, and chemical fate tests. The
puQlication of these guidelines (available tnrougn the
National Technical Innovation Service) will promote
consistent data submissions under TSCA. The juideiines,
which will be referenced in §4 test rules, -/ere developed
in close coordination with other federal agencies and tne
international Organization for economic Cooperation and
Development (OECD). They are consistent witn the testing
guidelines recently published by the OECD. OTS is now
developing additional guidelines for other tests, such as
short-term screening tests where no widely accepted
methodologies exist. OTS will perform an annual update of
published guidelines, based on public comment, to ensure
that they reflect the most current testing practices.
o Good Laboratory Practices (GLP's). OTS will be puDlishing
in the fall of 1983 a rule specifying "good laboratory
practices" that must be observed in developing health and
environmental effects data under TSCA §4 test rules. This
rule will specify recordkeeping ano data handling
procedures, animal care, personnel qualifications, and
similar practices that laboratories conducting tests in
compliance with TSCA will be required to observe. The
rules will ensure acceptable practices by testing
laboratories and will serve as a basis for audits under
OTS1 laboratory audit program. These GLP requirements
will also be incorporated into negotiated testing programs
and used in evaluating testing performed to respond to
§5(e) orders.
o Laboratory Audit Program. In cooperation with the food
and Orug Administration, OTS performs periodic inspections
and audits testing programs conducted under TSCA. Such
inspections are now being performed on tests carried out
under negotiated testing agreements? they will also apply
to § 4 test rules and will be extended to include testing
performed under §5(e) orders. Inspections ano audits will
be conducted both through a program of periodic review of
test facilities performing TSCA tests and as targeted
reviews of specific studies and test facilities, based on
the importance of the test or indications of test
problems.
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o Gene-Tox Program. This program, sponsored by OTS, is
designed to evaluate the current status of genetic
toxicology and its applications in testing chemicals for
potential mutagenicity and carcinogenicity. OTS personnel
and outside experts have evaluated availaDle literature on
selected mutagenicity and related assay systems to
document their performance in testing different chemical
classes and their ability to differentiate carcinogens and
noncarcinogens. From this work, an Assessment Panel will
prepare position papers recommending test oatteries for
generalized screening; for testing specific classes of
chemicals; for estimating risk; and for identifying
potential carcinogens. The papers are scheduled for
publication in 1984. The program as a whole will provide
valuable information in interpreting existing genetic
toxicity data and will provide guidance in selecting
appropriate tests in the future.
2. Exposure and monitoring data
Like health effects data, available monitoring and exposure
data can often be difficult to evaluate, for example, because of
questionable experimental design, improper handling of materials,
or inappropriate chemical analysis. Reliable exposure data,
however, are essential in identifying potential problems, in
estimating the magnitude of risk, in choosing among control
options, and in measuring the effectiveness of regulation or
other controls. For this reason, OTS has instituted a quality
assurance program designed to ensure that monitoring data
sponsored by EPA are reliaole.
This program, whicn is conducted under an EPA-wide quality
assurance program administered by the Office of Research and
Development (ORD), involves close OTS scrutiny of quality
assurance plans developed for each monitoring project under its
sponsorship. These plans typically address experimental design;
sampling procedures; handling, packaging, and shipping of
samples; laboratory quality assurance; data processing
procedures; and similar elements. As a result of its care in the
review of these plans, and in the design and conduct of its
monitoring projects, OTS can rely on the integrity of its data,
and be confident in their use as a basis for regulatory
decisionmaking. The success of this program was recently
acknowledged by ORD and the Administrator, which identified OTS
as a leader within EPA in several areas of quality assurance.*
*The EPA Administrator's First Quarter FY83 Accountability
Results singled out the OTS quality assurance program as a leader
in statistical and experimental design and data processing.
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CHAPTER V INFORMATION SHARING
AND TECHNICAL EXCHANGE
A. General Background and Current Activities
In developing TSCA, Congress clearly recognized the need for
broad public access to data on commercial chemicals and chemical
hazards, and it charged EPA with specific responsibility for
sharing data obtained under the Act with interested parties in
particular, otner federal agencies responsible for the protection
of health and the environment.* EPA's information-sharing
responsibilities are especially important because of its unique
authority under TSCA to gather or require the development of data
on commercial chemicals. In the course of its operations, OTS
has accumulated a significant body of health and environmental
effects data potentially of great value to other government
bodies and the public. Much of this information is not readily
available elsewhere. In addition, the information gathering and
data-development authorities EPA possesses in §4 and §6 of TSCA
could potentially be of great value in supporting regulatory
programs other than OTS. Similarly, the assessment methods and
technical tools described in Chapter IV may be useful to local,
state, and federal authorities responsible for public health and
environmental quality.
Examples of information and technical capabilities OTS now
has available, or will soon be developing, include:
o Data submitted under §3(a). Section 8(a) of TSCA
authorizes EPA to require chemical manufacturers and
processors to submit certain available information on a
*The Interagency Toxic Substances Data Committee (ITSDC), jointly
chaired by the Office of Pesticides and Toxic Substances and the
Council on Environmental Quality, is responsible for implementing
§10(b) of TSCA, which requires the development of (1) "an
efficient and effective system" for collecting, disseminating,
and using data developed under TSCA, and (2) "an efficient and
effective system" allowing EPA and other agencies to retrieve
toxicological and other scientific data. The major
accomplishment of the ITSDC to date has been the establishment of
the Chemical Substances Information Network (CSIN), which allows
access through bibliographic data bases to more 200 data bases
providing chemical information.
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chemical substance or mixture's identity, human and
environmental exposure, and health and environmental
effects. Within the last year, OTS has issued a §8(a)
asbestos rule, described in Chapter III, and a §8(a)
preliminary assessment information rule, which has been
used to obtain data on ITC chemicals and selected §8(e)
chemicals.* Data bases containing information submitted
under these rules are discussed in Chapter IV.
o Data submitted under §8(e). Section 8(e) requires
chemical manufacturers, processors, and distributors to
submit to EPA information that reasonably supports the
conclusion that a chemical substance or mixture presents a
substantial risk of injury to health or the environment.
Since this requirement went into effect in 1977, OTS has
received almost 500 submissions. In addition, OTS often
receives test reports submitted for its information rather
than as formal §8(e) submissions. Like §8(d) health and
safety studies, these submissions are a valuable source of
recent data on chemical risks, most of which are
unavailable elsewhere.
o Data submitted under §8(d). Under §8(d), EPA can require
persons to submit to the Agency health and safety studies
on specific chemical substances or mixtures. Under this
authority, OTS has obtained over 4,000 reports on health
and safety studies, collected primarily to support OTS'
evaluation of asbestos and chemicals recommended by the
ITC for testing consideration under §4(a). These reports
are generally unpublished, but for the most part are not
confidentlal.
o Analytical capabilities developed by OTS for estimating
exposure and physical-chemical properties and modeling
exposure. These capabilities, which include OTS' CHEMEST
and GEMS systems, are discussed in Chapter IV of this
report.
In addition, OTS is considering several initiatives under
§8(a) and other authorities, which would provide important new
information on commercial chemicals. These include a general
*In June 1982, OTS issued a preliminary assessment information
rule under §8(a) requiring information on approximately 250
chemicals. Future ITC designations and recommendations will be
automatically added to this list; other chemicals may also be
added in the future through notice-and-coiranent rulemaking.
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§8(a) followup rule for new chemicals, described in Chapter II,
and an Inventory updating project. The Inventory update project,
which is described in the Addendum to this report, would update
production volume and manufacturing site information for a subset
of chemical substances on the TSCA Chemical Substance
Inventory. This information would be invaluable not only to OTS,
but also to the other EPA offices and regions that use the TSCA
Inventory .
From the beginning, OTS has assigned a high priority to
sharing these types of information and promoting technical
excnanges, both with government agencies and the public.
Examples of current activities in this area include:
o Direct transmission of information obtained under TSCA to
appropriate organizations, e.g., routine forwarding of
copies of preliminary OTS evaluations of §8(e) submissions
to other federal agencies.
o Publication of technical material through the National
Technical Information Service, e.g., the TSCA test
guidelines for health and environmental effects and OTS'
chemical fate and preliminary evaluations of §8(e)
submiss ions.
o Encouragement of public participation in OTS' evaluation
of testing candidates recommended by the ITC.
o Publication of technical guidance documents, such as the
Asbestos in Homes Booklet and asbestos risk abatement
guidelines.
o Technical assistance to states and local organizations,
e.g., in monitoring and sampling techniques.
In several important respects, OTS will be expanding its
information-sharing activities in the near future:
o As discussed in Chapters II and III, OTS will be
developing Risk Management Advisories for selected
existing chemicals and Advisory Circulars for new
chemicals. These documents will provide the public and
industry information on risks identified in OTS reviews
and will describe control measures.
o OTS will publish quarterly reports identifying chemicals
under evaluation in its existing chemicals program, and it
will seek greater public participation in its preliminary
evaluations of existing chemicals.
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o OTS will be making a number of its data bases now under
development available to puolic users. The TSCA Inventory
data base is already available now through the NIH/EPA
Chemical Information System (CIS); as SPHERE, described in
Chapter IV, becomes operational, it will also be available
through this system.
o EPA will promote technical exchanges with states, federal
agencies, and foreign nations. OTS has already arranged
to share computational and modeling capabilities with the
Federal Republic of Germany and the Michigan Department of
Natural Resources. The EPA Office of Research and
Development, Office of Water, Office of Solid Waste, and
Office of Policy and Resource Management have also
expressed interest in using OTS modeling capabilities in
their own work.
The major barrier to broader public and governmental access
to data obtained under TSCA is the need to protect confidential
business information. Much of the information received by EPA
under TSCA particularly information related to chemical
identity, production volume, manufacturing processes, and use
is claimed as confidential by the submitter. For example,
approximately 94% of PMN's have at least some information claimed
confidential.* Section 14 of the Act contains strict provisions
for protecting confidential business information.
In conducting its operations, therefore, OTS must constantly
balance the need of other organizations and the public for access
to TSCA data with industry's need, reflected in §14, for the
protection of commercial secrets. In practice, this has meant
strict safeguards to prevent inadvertent disclosure of
confidential business information together with an affirmative
commitment to share as much information as possible on commercial
chemicals and potential hazards. OTS is pursuing this commitment
primarily in two areas: (1) agreements with other government
agencies to give them access to confidential information relevant
to their authority, and (2) publication of confidential business
information in an aggregated or otherwise masked form that will
not divulge commercial secrets.
*Generally, claims of confidentiality are made for only some of
the information in a notice. Claims are made most frequently on
chemical identity (74% of PMN's), process information (67%),
manufacturer's identity (64%), site of manufacture (55%), and use
(49%).
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In the past, OTS has developed clearance procedures allowing
employees of other federal agencies access to confidential
business information -- for example, in individual PMN 1 s --
particularly wnen their expertise has been needed in OTS1 own
reviews ana regulatory decisions. In the future, OTS will be
gathering an increasing amount of information directly relevant
to the regulatory efforts of other agencies. The Office
believes, as a result, that it will become necessary to develop
agreements with these agencies, giving them access to
confidential data ana governing their use of the data. These
agreements, which will be announced in the Federal Register, will
ensure that confidential information is appropriately protected
by the agencies with which it is shared. Two current examples
illustrate the nature of these agreements:
o OTS has formally agreed to provide CPSC with limited
access to confidential PMN information and to certain
information reported under the §8(a) Preliminary
Assessment Information Rule. In both cases, CPSC is
interested in information on consumer uses of chemical
substances. These agreements were announced last year in
the Federal Register (47 FR 17860, 48 FR 504).
o OTS has also agreed to provide OSHA limited access to
confidential business information concerning occupational
exposure to asbestos obtained under the §3(a) asbestos
reporting rule. This agreement was announced in the
Federal Register in February 1983. OTS is also in the
process of negotiating an interagency agreement with OSHA
for sharing other TSCA confidential business information.
As further data appropriate for sharing are developed, OTS
will explore the possibility of additional information-sharing
agreements, both with these and other government agencies.
In addition, OTS is committed to providing relevant
information to the public in summary or masked form so that it is
no longer confidential. Toward this end, for example, the Office
routinely publishes summaries or descriptions of confidential
business information contained in premanufacture notices and
other TSCA submissions these descriptions include "generic
names" describing the chemical type, descriptions of use,
production volume ranges, and similar masked descriptions, which
provide the public with information on the nature of the
confidential data. OTS also routinely publishes aggregated data,
such as the number of new chemicals that fall into a specific use
category or production volume range. The Office is now committed
to refining and expanding its aggregation techniques, so that it
can increase the public availability of data that otherwise would
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be confidential. Two current activities illustrate this
commi tment:
o The Agency has recently announced in the Federal Register
a methodology for aggregating production voTuii
information reported for the TSCA Inventory. Persons or
organizations without access to confidential business
information may now ask EPA to provide aggregated
Inventory production volumes for specific chemicals. In
the past, published production data for Inventory
chemicals have reflected only nonconfidential reports;
therefore, they may considerably underrepresent the total
production volume of a given chemical. The published
methodology allows far more accurate figures, generally
reflecting confidential as well as nonconfidential
reports.
o OTS is also developing aggregation methodologies for data
submitted under the §8(a) preliminary assessment rule and
the §8(a) asbestos rule. OTS' procedures for aggregating
data from these rules were published in the Federal
Register in June 1983.
These examples illustrate the general nature of OTS1
information-sharing activities. More broadly, the Office is
beginning a comprehensive review of information sharing ana
technical exchanges under TSCA, and it will form an OTS workgroup
to explore how it can more effectively promote these goals. In
particular, the group will investigate:
o The further development of agreements with other EPA
offices and federal agencies allowing access to
confidential data. (The initial goal will be to identify
what data OTS has to offer other agencies, and what data
they can share with OTS.)
o The feasibility of joint data development with other
agencies in addition to information sharing.
o The feasibility of using TSCA information-gathering or
development authorities (e.g., §§4 or 8) for other EPA
programs or other agencies.
o The sharing of information and technical capabilities with
industry, labor unions, public interest groups, and
states. (Again, the initial goal will be to identify
appropriate recipients of TSCA data, and to identify data
held by other organizations that might be of importance to
OTS.)
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In connection with these activities, the Office */ill be
setting up a program to ensure better information exchange and
coordination between OT3 and individual states. Many states have
developed or are now developing their own toxic substances
programs under which they are collecting chemical monitoring and
epidemiological data, conducting chemical risk assessments, and
in some cases making TSCA-type control decisions. These programs
may benefit significantly from general toxicity and exposure data
gathered under TSCA, chemical risk assessments conducted by OTS,
site-specific TSCA Inventory data or other site-specific data
gathered under §8(a), §8(e) reports by plant sites, OTS modeling
and monitoring expertise, and similar OTS capabilities and
information. At the same time, individual states may have data
or analyses of importance to OTS for example, data on
workplace practices and exposure, monitoring data,
epidemiological data, and chemical risk assessments. In the next
year, OTS will be working to ensure more effective coordination
with state toxics programs and to promote more effective
information sharing and technical exchanges.
B. International Activities
Since the passage of TSCA, OTS has actively participated in
a range of international programs concerning toxic substances
control. OTS' participation in these programs is important
because toxic substance issues often transcend national
boundaries, international chemical regulation affects trade in
chemicals and national chemical industries, and nations can
benefit significantly from the exchange of data and assessment
techniques. Not only does OTS contribute significantly to the
success of these programs through its technical expertise ana its
experience in chemical review and control, but OTS participation
also contributes significantly to the effectiveness of its own
operations and to chemical control in the United States.
The goals of OTS participation in international programs
include:
o Exchanging data and assessment methodologies and sharing
expertise gained in national toxic substances programs.
o Protecting health and the environment in the United States
and contributing to international environmental quality
through cooperation with other governments on
environmental problems of an international or global
nature.
o Developing testing and assessment methodologies that are
recognized internationally.
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o Conserving scarce testing resources by avoiding
duplicative testing.
o Eliminating or preventing the development of obstacles to
trade.
Representative examples of OTS1 work with international programs
and organizations are discussed briefly below.
1. QECD Chemicals Program
Perhaps the most visible and successful of OTS'
international efforts has been its participation in the Chemicals
Program of the Organization for Economic Cooperation and
Development (OECD), an international group composed of the major
industrial trading partners. Because national laws regulating
hazardous chemicals can create barriers to international trade in
chemicals, the OECD began a program in 1977 to harmonize its
member countries' approaches to toxic substances control. The
OECD Chemicals Program focuses primarily on the elimination or
reduction of barriers to international trade in chemicals and the
sharing of technical expertise.
A major accomplishment of the OECD program has been the
adoption in May 1981 of the Decision on Mutual Acceptance of
Data. This decision commits member states to accept data
developed in other member countries according to the OECD Test
Guidelines and Principles of Good Laboratory Practices.
More recently, OTS has participated actively in the new OECD
initiative on existing chemicals. As part of this activity, the
Office chairs the Switchboard Project, a referral system which
will improve access by member countries to unpublished
information held in other member countries. In addition, OTS
experts made significant contributions to the development of a
common format for chemical reviews, which will facilitate the
exchange of information, and to the development of methods for
setting priorities in the selection of testing candidates.
2. United Nations Programs
OTS participates in several United Nations programs, such as
the International Register of Potentially Toxic Chemicals (IRPTC)
of the U.N. Environmental Program (UNEP). The basic objective of
this register is to promote more efficient use of national and
international resources in the evaluation and control of chemical
risks. Toward this end, the IRPTC provides access to existing
data and distributes information on national and international
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regional policies, regulatory measures, and standards. OTS
supports the Register by notifying the program of chemical
incidents and proposed regulatory actions and by responding to
foreign inquiries relayed through the IRPTC.
OTS is also participating in a UNEP project to develop a
GloDal Ozone Protection Convention. Once adopted, this
convention will provide for better coordination and greater
cooperation among nations in research, monitoring, and
information exchange concerning stratospheric pollution ana
potential modification of the ozone layer. OTS has played an
important role in the development of the U.S. positions at
international deliberating and drafting sessions and has been
part of the U.S. delegation to these sessions.
In connection with these activities, OTS is playing a
central role in international efforts to improve global
monitoring of the earth's ozone layer. OTS currently chairs a
working group composed of representatives from other U.S.
agencies and international research organizations, including the
U.N. World Meteorological Organization and the Chemical
Manufacturers Association (CMA) Fluorocarbon Program Panel. OTS
and the CMA Fluorocarbon Program Panel have jointly funded a
project to establish seven automatic ozone monitoring stations
around the world. Scheduled to be completed in 1984, this global
network will collect important data on the vertical distribution
of stratospheric ozone that can be used to assess the status of
the ozone layer and to detect any abnormal changes that may be
taking place. Ultimately, such information should play an
important role in future decisions by the U.S. and other nations
on actions to protect stratospheric ozone.
3. Bilateral Activities
Many of OTS' international activities involve direct
relations with other nations or regional organizations, such as
the European Economic Community (EEC). Since 1978, OTS has been
regularly discussing toxic substances issues with the EEC
Commission. Initially discussions focused on OTS' implementation
of TSCA particularly in the area of new chemicals while the
EEC was still making plans for its Directive, commonly known as
the Sixth Amendment. More recently, as experience has been
gained on both sides, discussions have focused on problems
arising from differing approaches to chemicals management under
TSCA and the Sixth Amendment.
In addition, as mentioned in Chapter IV, OTS has developed
an agreement to exchange technical information with the
Umweltbundesamt (UBA) of the Federal Republic of Germany. The
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UBA has been particularly interested in OTS' progress in
developing capabilities for exposure modeling through its GEMS
program and in compiling, characterizing, and computerizing
methods for predicting the physical-chemical properties of
chemicals.
As part of the OECD Hazard Assessment Project, OTS has
provided the UBA with a computer model developed by OTS to
predict the environmental partitioning of a chemical. The UBA
plans to use this model, as does OTS, in its new chemical
assessments. In return, the UBA has provided OTS with
information on the practicability and limitations of OECD test
guidelines developed through interlaboratory comparisons. The
UBA has also shared with OTS preliminary reports describing the
formulation of its approach to hazard assessment. Most recently,
the UBA has proposed a cost-sharing program with OTS to enhance
OTS' CHEMEST computer program for estimating various physical-
chemical properties. These are similar programs will
significantly improve the ability of OTS and of foreign
governments to evaluate and control chemical hazards.
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Possible OTS Initiatives
The main text of this report describes the present status of
OTS' programs, the major program objectives for the near future,
and initiatives to which the Office is now committed. This
\daendum briefly discusses several additional initiatives that
OTS is now exploring, but that the Office has not yet adopted.
These initiatives are earlier in their planning stages than those
discussed in the main report, and generally they have not been as
completely articulated. Before decisions are made to pursue them
or how far to pursue them they will require more review,
both in terms of both policy and legal implications and in terms
of more practical procedural details. Furthermore, some"of these
initiatives may not be possible given current resource
constraints. For these reasons, certain initiatives may not De
adopted, while others may be phased in gradually as the Office
continues to gain experience in its new and existing chemicals
programs. In any case, however, tnese initiatives represent
alternative routes that OTS is now exploring to reach its program
goals.
I. New Chemicals
A. Data Development
Lack of health and environmental effects data in PMN' s in
many cases complicates OTS review of new chemicals. In a few
cases, it has led to suspensions of the review period pending the
development of data, withdrawal of notices, and §5(e) actions.
Many of the problems leading to such actions would have been
avoided if more data had been provided on the chemicals in
question in the first place. For this reason, the Office is
considering several alternatives that would more directly
encourage the development of data on categories of new chemicals
identified as a concern.
Initiative 1. Place categories of substances that have raised
concern in the PMN process on the 55(b)(4) "risk list."
Discuss ion. Section 5(b)(4) of the Toxic Substances Control Act
(TSCA) states that the Environmental Protection Agency (EPA) may,
by rule, compile a list of substances with respect to which it
finds that the manufacture, processing, distribution in commerce,
use, or disposal presents or may present an unreasonable risk to
human health or the environment. If a PMN (or a SNUR notice) is
submitted on a chemical listed under §5(b)(4), the submitter must
provide data that he believes show that the substance (or the new
use) will not present an unreasonable risk. As a result, under
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§5(b)(4) the burden is shifted to the manufacturer to show that
his product will not present such a risk; in a typical PMN, tne
submitter is not requirea to provide aata demonstrating the
safety or reasonableness of his product.
Under this initiative, OTS would place categories of
chemicals tnat had consistently raised concern during PMN review
on the §5(b)(4) list. These categories might be defined in terms
of chemical structure, exposure factors (sucn as use), or both.
The rule would specify the nature of the EPA concerns, and the
kinds of data that might address them. As a result, it would
provide guidance to notice submitters on the data that EPa
believes would be appropriate.
Although this approach would not require companies to
develop additional data on new chemicals belonging to listed
categories, it would provide a strong incentive to do so.
Furthermore, it would require notice submitters directly to
address the potential risks of these substances as they developed
their PMN's. At the same time, the approacn is consistent witn a
case-by-case review of new chemicals. The specific amount of
data appropriate for any given member of a listed category will
depend on its exact identity, toxicity potential, production
volume, uses, and similar factors. Both the manufacturer before
notice submission and EPA curing PMN review would address these
factors on a case-by-case basis in determining the proper level
of testing .
To implement this approach, OTS will have to, first,
identify appropriate categories for listing, and, second,
establish in the context of a rulemaking that they met the
standards for listing under §5(b)(4).* This effort could require
considerable resources. However, previous PMN detailed reviews
will provide significant portions of the supporting analysis.
* In listing a substance under §5(b)(4), EPA must find that its
manufacture, processing, distribution in commerce, use, or
disposal presents or may present an unreasonable risk of injury
to human health or the environment. To make this finding, EPA
must consider all relevant factors, including (1) the effects of
the substances on health and the magnitude of human, exposure, and
(2) the effects of the substances on the environment and tne
magnitude of environmental exposure.
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Inltlative 2. Issue §4 test rules for chemical categories that
have raised concern in the PMN process.
Discussion; Under this initiative, OTS would develop §4 test
rules on categories of new chemicals identified as concerns in
the PMN process rather than (or in addition to) listing the
categories under §5(b)(4). The rules -vould require companies to
develop specific health or environmental effects data on new
chemicals in these categories of concern before suDmitting a P*iN.
This initiative would be a considerably stronger action than
initiative 1, because notice submitters would have to provide
data specified by OTS in the rulemaking, whereas under initiative
1 the submitter would only be required to provide data that he
believed showed that the material would not present an
unreasonable risk. It might also save OTS review resources.
Under initiative 1, if EPA found the data were insufficient, it
would take action under §5(e). Because the data requirements
would be specified by rule, initiative 1 would reduce the need
for individual §5(e) orders. The disadvantage of this approach
is its inflexibility. It would be difficult to specify the exact
level of testing appropriate for all members of the category,
and, if a tiered approach were developed, to define objective
criteria for moving to the second tier of testing.
B. New Chemical Follow-up
Initiative 1. Develop a "metoo" SNUR automatically extending
the conditions of §5(e) orders to subsequent manufacturers and
processors.
Discuss ion. The terms of a §5(e) order restricting the
manufacture, processing, use, or aisposal of a new chemical
substance apply only to the PMN submitter. Once the submitter
begins commercial manufacture, the substance is entered on the
TSCA Inventory and can be manufactured or processed by other
companies without restriction. For this reason, when OTS issues
a limited §5(e) order, it also routinely develops SNUR's
requiring companies to notify EPA before they manufacture or
process the substance outsidelthe terms of the §5(e) order.
Although this approach generally protects against unreviewea
use of the PMN substance outside the terms of the order, there
are two difficulties with it. First, because of the time needed
to develop a rule, there is inevitably a gap between expiration
of the PMN review period and proposal of the SNUR. This leads to
at least the possibility that new uses of concern may occur
before proposal of a SNUR. Second, it requires considerable
resources to develop SNUR's on a case-by-case Dasis as §5(e)
orders are issued.
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To address these difficulties, OTS is considering the
possibility of developing a "ne-too" significant new use rule,
which would automatically impose SNUR notice requirements on all
importers, manufacturers, or processors of chemical suDstances
s'ubject to limited §5(e) orders. As a result of this rule, tne
restrictions of §5(e) oraers would apply inaustry-wiae.
Initiative 2. Issue §8(a) follow up rules together with SNUR's.
Discussion. New chemical SNUR's focus on specific uses or
exposure scenarios that have been identified as a concern.
SNUR's would generally prevent these uses from occurring without
prior EPA notice.
There is always the possibility, however, that uses of
concern might not be reported. For example, manufacturers or
processors might in good faith misinterpret the trigger for
example, if it were something like "manufacture for consumer
use," they might misunderstand the meaning of consumer use or
they might fail to recognize the exact nature of their own
activities or those of their customers. Furthermore, it is also
possible that uses of concern might occur that had not been
anticipated during PMN review, and therefore would not be subject
to SNUR notice requirements.
To address these problems, OTS is exploring the possibility
of developing §8(a) rules in conjunction with SNUR's. The rules
-light, for example, require companies manufacturing or processing
a chemical subject to a SNUR to provide EPA certain limited
information on tnat chemical every few years. This vould allow
OTS to ensure that significant new uses, as defined by the rule,
did not inadvertently occur, and in addition, that no
unanticipated new uses of concern developed.
These rules would require few OTS resources to develop
beyond those already needed to develop the SNUR's they
accompany. However, they would increase the reporting Durden on
industry. If EPA develops a general §8(a) follow-up rule, the
need for issuing §8(a) rules together with SNUR's would be
somewhat reduced.
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C, Oither Initiatives
Initiative 1. Develop a TSCA biotechnology program to ensure
that risks from TSCA uses of genetically engineered material are
appropriately controlled.
Discuss ion. Blatscnnology has until very recently been a
laboratory-scale phenomenon; however, commercial uses potentially
subject to TSCA regulation are now under development. (Examples
include microorganisms used in pollution control, mining and
petroleum drilling, controlling oil spills, etc.) Signiticant
risks may be associated with some of these uses of biotechnical
substances, particularly as a result of their release into the
environment. OTS is now reviewing the applicability of TSCA to
these products and is considering the possibility of a broader
effort to ensure that health and environmental risks they may
pose as a result of TSCA uses are appropriately characterized and
controlled.
Preliminary analysis indicates that OTS has jurisdiction
over biotechnology under TSCA and that new genetically engineered
substances nay be new chemical substances subject to PMN
requirements. However, any review of biotechnical material by
OTS under TSCA authority in particular the new chemical
authority will raise a series of technical and policy issues,
vhich the Office is now addressing:
o Assuming OTS jurisdiction, should OTS address all of
olotechnology or only genetic engineering?
o How well adapted are TSCA regulatory mechanisms and tne
current TSCA regulatory structure for the review and
possible control of risks posed by biocechnical
material?
o Where should the line be drawn between "naturally
occurring" life forms, which are not subject to PMN, and
"new" life forms, which arguably are?
o How can differences at the DNA level be described
(i.e., how would a new life form be characterized for
Inventory and PMN purposes)? Can these differences be
evaluated in terms of health and environmental concerns?
o Assuming an OTS role in this area, how is the Office
going to obtain the necessary expertise to address
biotechnology risks? How should it ensure coordination
with other regulatory and research agencies?
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In reviewing the possioility of a TSCA role in
characterizing and controlling risks from genetically engineered
material, OTS will oe beginning a dialogue .vith other regulatory
or research groups who are now involved in o10tecnnology or may
be in the future (e.g., NIH, FDA, HHS, and NIOSH). Options and
recommendations -vill be preoared for OTb management by tne fall
of 1983.
II. Existing Chemicals
Initiative 1 ~ Issue triggered §4 rules to require testing of low
production/exposure/release chemicals for which existing data
indicate a need for testing if production, exposure, or release
were to increase.
Piscussion. OTS has found that several ITC chemicals do not
warrant §4(a) rulemaking because of low production or highly
limited exposure and release. In some instances, OTS has
developed or is considering the development of §8(a) reporting
rules or §5(a)(2) SNUR's to ensure that it is alerted to
commercial changes that would warrant OTS reconsidering the need
for testing. A possible alternative in such cases is to develop
"triggered" §4(a) rules that would take effect only when
production volume, exposure, or release criteria contained in the
rule were exceeded. These rules could oe developed alone or in
conjunction witn §8(a) or §5(a)(2) rules.
This approach would provide greater assurance that EPA would
get the needed test data if production volume, exposure, or
release increased. It would also trigger the cost sharing
provisions of §4, so that all manufacturers of the suDstance,
rather than simply the manufacturer who exceeded the production
volume trigger, would be responsible for funding the testing.
Initiative 2. Issue significant new use rules on §4 chemicals to
ensure that production does not increase or new uses develop
before testing is completed.
Discussion. Section 4 test rules (and negotiated agreements)
generally do not control human or environmental exposure to the
substances under test, nor do they prevent further commercial
development before the test data are developed. For example, the
production volume of a §4 chemical could increase significantly
while long-term tests were underway, increasing the extent of
human and environmental exposure (and therefore, potentially,
risk) and possibly complicating subsequent regulation. One way
to prevent this occurrence would be to issue a §5(a)(2)
significant new use rule requiring notification of EPA before
production volume increased or new uses developed.
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Such a rule would effectively set a cap on uncontrolled
commercialization of §4 chemicals. Companies would have to stay
within the bounds defined by the SNUR until the §4 test data were
developed, thereby preventing the chemicals from securing a
larger market before data sufficient to assess their risks had
peen developed.
The simplest triggers for notification in these SNUft's would
be production volume limits. While other triggers might in some
cases be feasible, they would be difficult to develop,
particularly because most chemicals considered for test rule
development are already widely used. As a result, new end uses
would be relatively unlikely, and therefore a SNUR for such uses
would be unnecessary.
Initiative 3: Update the TSCA Chemical Substance Inventory
through a §8(a) rule.
Discuss ion. In compiling the TSCA. Chemical Substance Inventory
a list of chemical substances in U.S. commerce EPa
collected supplementary data on production volume and site of
manufacture. These data are now used for such purposes as
conducting preliminary screens of chemicals (e.g., in selecting
ITC testing candidates) and identifying manufacturers (e.g., for
analyzing the impact of §4 test rules and the §8(a) preliminary
assessment rule). In addition, the Inventory is also used by
other EPA offices (e.g., the Office of Solid Waste, Office of
Emergency Response), EPA regions, and the states as a source of
production and plant site information on chemicals of concern.
However, Inventory data on production volume and manufacturing
sites, which were collected between 1977 and 1979, are becoming
obsolete. For this reason, OTS is considering the possibility of
updating the Inventory or a subset of chemicals on it.
Toward this end, OTS plans to issue an ANPR, which will
solicit public comments on updating information on a subset of
the 60,000 chemicals now on the Inventory. The subset could be
developed by excluding certain chemicals, such as high-molecular
weight polymers or certain inorganic substances generally found
to be of low concern. In addition, the rule mignt be restricted
to certain categories, such as chemicals produced at more than a
certain production volume, §8(e) chemicals, and former PMN
chemicals. In this way, the reporting requirements would be
focused on chemicals more likely to be of concern.
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In.itiative 4: Select existing chemicals for OTS evaluation
through a priority-setting system, which would assign aggregate
measures of risk to categories of chemicals with similar uses or
structures.
Discussion: At the present, OTS efforts on existing cnemical?
are triggered largely oy TSCA §3 reporting mecnani srns (esGeci. -iy
58(e)) and through literature reviews. A few existing cnemical
projects result from referrals from other EPA programs and other
agencies. As a complement to tnese procedures, OTS is now
exploring the possibility of developing a quantitatively oased
prioritization system that would indicate the relative hazard
posed by different categories of existing chemicals, such as use
categories.
Under this prioritization approacn -- unlike most earlier
OTS approaches chemicals would De categorized. The categories
(or "clusters") could oe based on similarity of use or other
characteristics, such as chemical structure. A measure of the
degree of risk, posed by each cluster would De developed on the
basis of parameters such as production volume, number of workers
exposed, and toxicity measures for each chemical in the
cluster. When total risk values were developeo for each cluster,
the clusters would be ranked. OTS review would tnen oegin on the
chemicals within the highest priority cluster, proceeding to
those in the second highest priority cluster, and so on.
The use of cluster analysis to set priorities among existing
chemicals has several advantages. First, such a system would be
useful in identifying major categories of potential concern,
warranting review under the existing chemicals program. Second,
the system is essentially quantitative, so that subjectivity is
limited. Third, the use of chemical clusters based on use or
chemical class permits the evaluation of chemical substitutes at
the same time. Fourth, this method tenos to increase the
efficiency of reviews, because data are gathered and analyses
performed on chemicals with similar uses or structure at the same
time. If such a system appears feasible, OTS believes that it
would provide a useful complement to its current approach
identifying candidates for existing chemicals review.
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