KF3958
.A84
1977
OOOK77001
Tirst Annual Report (1977)
Administration of the
Substances
Cotjtrol
U.S. ENVIRONMENTAL PROTECTION AGENCY
-------
-------
FIRST ANNUAL REPORT-1977
ADMINISTRATION
OF THE
TOXIC SUBSTANCES CONTROL ACT
U.S. ENVIRONMENTAL PROTECTION AGENCY
-------
-------
CONTENTS
Organization and Staffing 1
Strategy 2
Testing 2
Chemical Inventory 3
Reporting and Recordkeeping 4
Chemical Control Regulations 5
Rulemaking Procedures 5
Compensation for Public Participation 6
Pre-Manufacturing Notification 6
Penalties 6
Industry Assistance 7
Coordination 7
Problems 8
Legislation 9
Chemicals Recommended by Interagency
Committee for Priority Testing 9
Questions and Answers on TSCA Initial
Reporting Regulations 12
-------
-------
January 17, 1978
The President
The White House
Washington, D.C. 20500
Dear Mr. President:
I am pleased to transmit to you the Environmental Protection
Agency's (EPA) first Annual Report on the administration of the
Toxic Substances Control Act (TSCA). This report provides the
information required by Sections 30 and 9(d) of the Act, as well as
additional information on EPA's activities under the Act.
ORGANIZATION AND STAFFING
In accordance with Section 26(g), EPA has established the position
of Assistant Administrator for Toxic Substances. Your appointment
of Mr. Steven D. Jellinek to this position was confirmed by the Senate
on October 12, 1977. An organizational plan for the Toxic
Substances program has been developed and will be approved in the
near future. The responsibilities of the Assistant Administrator for
Toxic Substances include both the Toxic Substances and Pesticides
programs. Because these two programs have much in common,
placing them under the purview of a single Assistant Administrator
will be beneficial to both of them.
The Assistant Administrator for Toxic Substances also is
responsible for promoting Agencywide integration of toxic substan-
ces control activities. Toxic chemicals are receiving increasing
attention in the Agency's air and water pollution control, drinking
water, and solid waste management programs. There is a real need to
ensure that the activities of these programs, as they relate to toxic
substances that may endanger human health or the environment, are
well coordinated.
The Assistant Administrator for Enforcement and the Assistant
Administrator for Research and Development, as well as EPA's
Regional Administrators, also play important roles in the implemen-
tation of the Toxic Substances Control Act. The Assistant Adminis-
trator for Enforcement has established a Pesticides and Toxic
Substances Enforcement Division. The Assistant Administrator for
Research and Development, jointly with the Assistant Administra-
tor for Toxic Substances, is developing an initial plan for research
and development in support of TSCA implementation. In each of
EPA's Regional Offices, a Toxic Substances Coordinator has been
designated, and efforts are underway to integrate toxic substances
control activities in the Regional Offices.
In October 1976, when TSCA became law, the Agency's resources
allocated specifically for the Toxic Substances program amounted to
45 positions and $7.0 million. In Fiscal 1978, the allocation for TSCA
implementation, including research and development, is 319
-------
positions and $27.8 million. Many of the additional positions are
already filled; recruitment to fill the others is continuing. Special
efforts are being made to recruit toxicologists and other specialists
who have the expertise needed to deal with TSCA problems.
STRATEGY
The number of chemicals covered by the Toxic Substances Control
Act is very large. Estimates of the number of chemicals produced in
the U.S. for commercial purposes range up to 70,000. Estimates of the
number of new chemicals introduced annually run as high as 1,000.
For the Environmental Protection Agency, the work involved in
identifying and assessing human health and environmental risks and
in developing and enforcing rules and regulations to prohibit or
restrict the manufacture, processing, distribution, use, and disposal
of chemical substances and mixtures will be labor-intensive and time-
consuming. For the chemical industry, the costs of compliance with
EPA's testing requirements and regulatory restrictions could be
substantial. Accordingly, it is essential that EPA establish priorities
for all its TSCA activities, including testing, monitoring, data-
collection, and rulemaking.
A system for establishing priorities will be the heart of EPA's
strategy for implementation of the Act. In the near future, the Agency
will distribute for public review and comment a draft strategy
document now being developed in the Office of the Assistant Admin-
istrator for Toxic Substances. This document will outline a priority-
setting system in general terms and will also describe the Agency's
current thinking about implementation of key parts of the Act. A
follow-up document, due to be completed later, will lay out a priority-
system in much greater detail; when completed, it also will be
distributed for public review and comment.
In developing these strategy documents, the Assistant Adminis-
trator for Toxic Substances is consulting people in other EPA
programs and is building on the Agency's earlier TSCA strategy de-
velopment efforts. A preliminary paper was distributed for public
review and comment in February 1977. Both before and after its
distribution, the Agency held public meetings to discuss TSCA
implementation. Meetings were held not only in Washington, D.C.,
but also in nine other cities around the U.S.
TESTING
Section 30(1) requires that the Annual Report include a list of the
testing required under Section 4. Thus far no testing requirements
have been issued. Within the Agency, work is underway on the devel-
opment of standards for carcinogenicity, environmental fate, and
ecological effects testing. Preliminary work is underway on standards
for teratological and behavioral toxicity testing. As far as possible,
-------
TSCA testing standards will be harmonized with other Federal
agencies' and foreign governments' testing standards.
Efforts to identify the chemicals to be covered by the initial testing
requirements also are underway. A method of selecting chemicals to
be tested—based on their potential impact on human health and the
environment—will be an integral part of the system for establishing
priorities for TSCA implementation.
Section 4(e) calls for the creation of an interagency committee to
recommend testing priorities. In October 1977, this group made its
initial recommendations; it recommended various types of toxicolog-
ical and environmental testing of four individual chemicals and six
groups of chemicals. Attachment A is a summary of the recommen-
dations. EPA has one year from the receipt of the recommendations
to initiate action to require the recommended testing or to state
publicly its reasons for not doing so. As one of its initial steps in
assessing the recommendations, the Agency soon will publish
proposed rules under Section 8(d); the proposed rules would require
chemical manufacturers and processors to submit lists and copies of
pertinent health and safety studies already performed with respect to
the chemicals covered by the committee's recommendations. EPA is
also examining its own files, and asking other Federal agencies to
examine theirs, to determine whether such studies have already been
performed. Where the recommended types of studies have already
been performed in a way that produced reliable results, it obviously
would not be desirable to require that it be performed again.
CHEMICAL INVENTORY
Section 8(b) requires the Agency to compile and publish an
inventory of chemicals in commerce. Beginning 30 days after
publication of this inventory, no person may manufacture or import
for commercial purposes a chemical not included in the inventory
without submitting premanufacturing notice under section 5.
Compilation of the inventory is now underway. An initial inventory,
based on information furnished by chemical manufacturers, will be
published in late 1978.
In December 1977, the Agency issued rules specifying who is
required to report and what information must be reported.
Attachment B summarizes the reporting rules. In brief, those
chemical manufacturers (including importers) who are required to
report will have until May 1, 1978, to report the identity and
production volume of chemicals manufactured at each production
site during calendar 1977. Chemicals manufactured during the two
preceding years also may be reported for inclusion in the inventory.
EPA's rules include provisions limiting the reporting requirements
applicable to small business and allowing confidentiality claims to be
made.
-------
Development of the Agency's 8(b) reporting rules took more time
than TSCA provided, largely because of the time required to work
out satisfactory ways of dealing with a number of sensitive issues.
Questions concerning the applicability and scope of the reporting
requirements, treatment of small business, and handling of
information subject to confidentiality claims were raised by the
chemical industry and other interested parties. EPA took the unusual
step of publishing a second set of proposed rules after reviewing the
public comments on its initial proposal. In addition, Agency
employees involved in developing the rules had many meetings with
industry and public interest representatives, officials of other Federal
agencies, representatives of foreign governments and international
organizations, and other interested parties. Though the decision to
publish a second proposal caused a delay in compilation of the
inventory, the result was a set of rules that will enable EPA not only to
satisfy the 8(b) requirement but also to obtain data needed to begin
methodically establishing priorities for attention and action under
TSCA.
REPORTING AND RECORDKEEPING
In addition to calling for compilation of an inventory of
commercial chemicals, Section 8 authorizes the Agency to obtain
other types of information needed for determinations about human
and environmental risks. Toward this end, the Agency is authorized
to require reporting of data on production, uses, worker exposures,
by-products, and disposal methods, as well as existing data on
environmental and health effects. The Agency also is authorized to
require submittal of lists and copies of health and safety studies and to
require maintenance of records on adverse reactions to chemicals.
Development of rules for such reporting and recordkeeping is in
progress.
Also under Section 8, chemical manufacturers, processors, and
distributors are required to furnish information which reasonably
supports the conclusion that a chemical substance or mixture
presents a substantial risk of injury to health or the environment. The
Agency has published proposed guidance indicating what kinds of
information should be submitted. Final guidance will be issued after
the Agency completes its review and analysis of public comments.
Approximately 35 "substantial risk" notices have already been
received. Most of them have concerned chemicals already being
studied by EPA or chemicals produced in such limited amounts that
human and environmental exposure to them is minimal. Some have
presented information already available in published literature. All
such notices are reviewed in EPA, and copies are routinely
distributed to the Occupational Safety and Health Administration,
the Food and Drug Administration, and the Consumer Product
Safety Commission.
-------
CHEMICAL CONTROL REGULATIONS
Section 30(3) requires that the Annual Report include a list of rules
issued during the year under Section 6, which authorizes the Agency
to prohibit or restrict the manufacture, processing, distribution, use,
and disposal of chemical substances and mixtures, and, in some
instances, articles containing chemical substances and mixtures.
Under Subsection 6(e), the Agency is engaged in rulemaking
dealing with polychlorinated biphenyls (PCBs), which are a
widespread and hazardous environmental contaminant. Proposed
rules establishing requirements for PCB marking and disposal were
issued in May 1977. Public hearings were held the following month. It
is anticipated that final marking and disposal rules will be issued in
January 1978.
Subsection 6(e) also prescribes a timetable for phasing out the
manufacture, processing, distribution, and use of PCBs, with certain
limited exceptions. Proposed rules covering the phase-out and
defining exceptions have been developed and are expected to be pub-
lished in January 1978. Since it will be administratively and legally
difficult to enforce the statutory restrictions until the Agency issues
final rules defining the terms of these restrictions and the conditions
under which exceptions will be made, no implementation action will
be initiated until final rules are issued and take effect. It is expected
that the final rules will be issued in April 1978. It should be noted,
however, that the manufacture of PCBs in the United States has
already ceased, and that many producers of items in which PCBs had
been used have been switching to substitute materials.
Under Section 6(a), proposed rules prohibiting nonessential
aerosol uses of chlorofluorocarbons were issued in May 1977. These
rules were developed and issued jointly with the Consumer Product
Safety Commission and the Food and Drug Administration. Public
hearings were held in August 1977. It is anticipated that final rules will
be issued in February 1978.
An investigation of the need for rulemaking is underway with
respect to polybrominated biphenyls (PBBs). A few years ago, PBBs
were accidently mixed with livestock feed in Michigan and caused
extensive harm. EPA is now gathering information on production
and uses of PBBs, and on human and environmental exposure to
PBBs, in order to provide a basis for determining whether regulatory
action is necessary.
RULEMAKING PROCEDURES
Under Section 6(c), the Agency has issued rules establishing
procedures to be followed in providing an opportunity for interested
persons to present their views on proposed regulations affecting the
manufacture, processing, distribution, use, and disposal of chemi-
cals. Among other things, the rules provide for presentation of
-------
testimony to an expert panel and an opportunity for cross-
examination to aid in resolving disputed factual issues. In addition,
the rules reflect the requirements of Section 6 for issuance by EPA of
documentation in support of proposed regulations.
COMPENSATION FOR PUBLIC PARTICIPATION
Also under Section 6(c), the Agency has issued temporary rules
under which interested persons may be compensated for certain
expenses related to participation in rulemaking proceedings. The
temporary rules establish a pilot program related specifically to the
forthcoming rulemaking on phasing out manufacture, distribution,
and use of PCB's. In accordance with Section 6(c), the rules provide
that the Agency may provide compensation for reasonable attorneys'
and expert witnesses' fees and related costs of participating if the
participant "represents an interest which would substantially
contribute to a fair determination of the issues to be resolved" and if
either the participant's economic interest in the issues is small in
comparison to the costs of participation or the participant would not
have the resources to participate if compensation were not granted.
Persons who would be regulated by the proposed rules or who
represent regulated parties are eligible for compensation, but the
aggregate amount paid to such persons may not exceed one-quarter
of the total amount paid to all participants.
PRE-MANUFACTURING NOTIFICATION
Section 30(2) requires that the Annual Report include information
on manufacturing and processing notices received under Section 5
and on actions taken with respect to such notices. The requirement
that manufacturers notify the Agency before manufacturing a new
chemical will not become effective until 30 days after publication of
the initial inventory of commercial chemicals. As indicated above, it
is expected that the initial inventory will be published in late 1978. In
the meantime, the Agency is beginning to develop plans and policies
for implementing section 5. A Pre-Manufacturing Review Division is
being established and will have as its sole responsibility the
implementation of section 5. Thus, it will be able to focus its attention
exclusively on the important task of identifying and dealing with new
chemicals that may present significant hazards to human health and
the environment.
PENALTIES
Section 30(4) requires that the Annual Report provide information
on judicial and administrative actions completed or pending under
Section 16. Section i6 prescribes civil and criminal penalties for
violations of certain provisions of the Toxic Substances Control Act
and rules issued under those provisions. Thus far, no action has been
-------
initiated under Section 16. Within the Agency, work is underway on
the development of rules establishing administrative procedures for
assessment of civil penalties.
INDUSTRY ASSISTANCE
In accordance with Section 26(d) of the Act, the Agency has estab-
lished an Industry Assistance Office to furnish the chemical industry
information on implementation of the Act and on requirements
applicable to manufacturers and processors. From its inception, the
IAO has agressively been reaching out to chemical manufacturers
and processors instead of simply reacting to requests for assistance.
lAO's activities have included the development of a mailing list
comprising about 37,000 names, of which 26,000 are people involved
in manufacturing, processing, and importing chemicals; the
remainder are other persons interested in TSCA implementation.
Copies of rulemaking notices and other significant documents are
distributed via the mailing list. Among other things, IAO has
distributed more than 11,000 copies of the Candidate List of
Chemical Substances in response to requests. The Candidate List
contains the names and CAS Registry Numbers of approximately
30,000 chemicals; it is designed solely to simplify the chemical
industry's task when it is reporting the identity of commercial
chemicals for purposes of EPA's compilation of the inventory under
section 8(b).
Over the past several months, IAO has received an average of 175
telephone requests and 50 letters per week. In addition, IAO staff
members have discussed TSCA implementation at meetings of 23
organizations and at nine regional meetings. EPA's Regional Offices
have also been quite active in providing information both to industry
and the public.
COORDINATION
Section 9(d) requires that the Annual Report include information
on actions taken to coordinate TSCA activities with related activities
under other Federal statutes, including statutes administered by
other Federal agencies.
Of particular note in this respect is the creation of the Interagency
Regulatory Liaison Group (IRLG) by EPA, the Consumer Product
Safety Commission (CPSC), the Food and Drug Administration
(FDA), and the Occupational Safety and Health Administration
(OSHA). These four agencies, which play significant roles in
protecting human health and the environment from the adverse
effects of toxic substances, have entered into an Interagency
Agreement to "cooperate with each other as far as is practicable to
make the most efficient use of resources, achieve consistent regulatory
policy, and improve the protection of the public health and
environment."
7
-------
IRLG working groups are involved in efforts to develop consistent
or compatible approaches to testing, epidemiological studies, risk
assessment, data management and exchanges, research and develop-
ment, regulatory procedures, compliance and enforcement proce-
dures, and public education.
Even before the creation of the IRLG, the participating agencies
had begun working jointly on specific projects. As indicated above,
for example, EPA, CPSC, and FDA are working together on
regulating the use of chlorofluorocarbons. With the creation of the
IRLG, it is expected that cooperation among the four agencies will
increase significantly.
PROBLEMS
Section 30(5) requires that the Annual Report include a summary
of major problems encountered in the implementation of the Act. As
there are with all new legislation, there have been start-up problems
with TSCA; in this case, however, the problems have been somewhat
different from those EPA previously has encountered. Unlike most of
the other new legislation EPA has had to implement, TSCA did not
evolve from previous law. Accordingly, while there already was a
small toxic substances program (focused primarily on problem
identification and definition) in the Agency at the time TSCA was
enacted, the Agency had no actual experience on which to rely. An or-
ganization had to be developed. Senior managerial officials had to be
recruited. A conceptual approach to implementation of the Act had
to be formulated. To varying degrees, all these tasks still are
unfinished.
A major conceptual problem that has to be resolved is that of es-
tablishing priorities. This is discussed in the section of this report
dealing with development of TSCA strategy.
There are. and will continue to be, significant policy and
procedural problems related to the Agency's obligations under
Section 14, which spells out the conditions under which the Agency is
to protect or release information which the chemical industry claims
is confidential. A solution has been worked out in the case of the 8(b)
requirement for publication of an initial inventory of chemicals in
commerce. But there will be other instances in which, broadly
speaking, the Agency's obligations to release information to the
public and to use information in support of TSCA implementation
will come into conflict with its responsibilities under section 14 and
the chemical industry's legitimate interest in keeping certain
information confidential. Again, this problem is one that will require
the Agency's continuing attention.
-------
LEGISLATION
Section 30(6) requires that the Annual Report include such
recommendations for additional legislation as the Administrator
deems necessary to carry out the purposes of the Act. At this time, the
Agency is making no such recommendations.
Respectfully yours,
Douglas M. Costle
FACT SHEET
ALKYL EPOXIDES
TESTING RECOMMENDATIONS:
Carcinogenicity
Mutagenicity
Teratogenicity
Other Chronic Effects
Environmental Effects
Epidemiology
Production, Release and Exposure: Although these compounds are
generally used as industrial intermediates, several alkyl epoxides are
produced in very large quantities (e.g., ethylene oxide at over 4 billion
pounds per year). The vast amounts produced thus raise concerns
primarily with respect to workplace exposure. The reactivity of these
compounds is such that environmental persistence is not anticipated;
however, their reaction products may be of significance.
ALKYL PHTHALATES
TESTING RECOMMENDATIONS:
Environmental Effects
Production, Release, and Exposure: Many of these compounds are
produced in large volume, some of them over one hundred million
pounds per year. Their use as plasticizers in a wide variety of prod-
ucts results in large volumes of alkyl phthalates reaching the aquatic
environment either as wastes from formulating plants or from use
and disposal of end products.
-------
CHLORINATED BENZENES, MONO- AND DI-
TESTING RECOMMENDATIONS:
Carcinogenicity
Mutagenicity
Teratogenicity
Other Chronic Effects
Environmental Effects
Epidemiology
Production, Release and Exposure: The chlorobenzenes are pro-
duced in large quantities, monochlorobenzene over 300 million
pounds/ year and ortho- and para-dichlorobenzene approximately 50
million pounds each. These chemicals are widely used in industrial
processes, as solvents, and in many consumer products. Therefore,
the exposure and potential for hazard is great, particularly in light of
their high release rate and anticipated persistence in the environment.
CHLORINATED PARAFFINS, 35-64% CHLORINE
TESTING RECOMMENDATIONS:
Carcinogenicity
Mutagenicity
Teratogenicity
Other Chronic Effects
Environmental Effects
Production, Release, and Exposure: The 1972 annual production of
chlorinated paraffins was about 80 million pounds. The use of these
materials in a wide variety of household and paint products, as well as
adhesives and flame retardants, results in an estimated release rate of
about 50 million pounds per year.
CHLOROMETHANE
TESTING RECOMMENDATIONS:
Carcinogenicity
Mutagenicity
Teratogenicity
Other Chronic Effects
Production, Release, and Exposure: The 1974 U.S. production of
chloromethane was over 350 million pounds, most of this being used
as a synthetic intermediate. However, it is estimated that about 5% of
the annual production (over 15 million pounds per year) is released
into the environment. NIOSH estimates that the number of workers
exposed to chloromethane numbers about 31,000.
10
-------
CRESOLS
TESTING RECOMMENDATIONS:
Carcinogenicity
Mutagenicity
Teratogenicity
Other Chronic Effects
Environmental Effects
Production, Release, and Exposure: Cresols are produced in large
quantities, having a combined U.S. production in 1975 of about 90
million pounds. An annual release rate of about 45 million pounds
has been estimated. Their wide use as industrial solvents leads to
substantial occupational exposure. NIOSH estimates that roughly
two million workers are exposed to cresols. In addition, cresols are
used in many consumer products, resulting in a large general
exposure.
HEXACHLORO-1,3-BUTADIENE
TESTING RECOMMENDATIONS:
Environmental Effects
Production, Release, and Exposure: Although the most recent (1974)
data available indicate that this compound is no longer commercially
manufactured in the U.S., it continues to be produced as a waste
byproduct of various chlorination processes and is also imported into
the U.S. for industrial solvent use. The release of hexachlorobuta-
diene into the environment has not been quantified, but there is good
evidence of widespread distribution in the aquatic environment.
NITROBENZENE
TESTING RECOMMENDATIONS:
Carcinogenicity
Mutagenicity
Environmental Effects
Production, Release, and Exposure: U.S. production of nitroben-
zene in 1975 was about 400 million pounds. Its release to the
environment has been estimated to be about 20 million pounds
annually. Although its predominant use (97 percent of production) is
in closed systems in aniline manufacture, nitrobenzene is also an
industrial solvent and dye intermediate. General population
exposure can arise from environmental release, and from dispersive
uses such as perfume in soap; cleaner for woodwork, wood flooring
and paneling; ingredient of metal polishes and shoe blacking.
Nitrobenzene liquid and vapor penetrate intact skin readily, and the
efficiency of vapor absorption by inhalation is high.
11
-------
TOLUENE
TESTING RECOMMENDATIONS:
Carcinogenicity
Teratogenicity
Other Chronic Effects
Epidemiology
Production, Release and Exposure: Toluene is produced in large
quantities with an annual production rate in excess of 5 billion
pounds. Because of its widespread use as a solvent, as well as a
multiplicity of other uses, toluene has an unusually high occupational
exposure (over 1 million workers). Its presence in many consumer
products leads to a large general exposure. Toluene is currently being
substituted for many benzene-uses and has an annual release rate
exceeding 1 billion pounds.
XYLENES
TESTING RECOMMENDATIONS:
Mutagenicity
Teratogenicity
Epidemiology
Production, Release and Exposure: In the aggregate, approximately
8 billion pounds of xylenes are produced each year. Approximately
900 million pounds are released to the environment each year. Mixed
xylenes were ranked by NIOSH 13th out of approximately 7000
agents in terms of the number of workers exposed. Xylenes are also
used in a wide variety of consumer products, resulting in general
population exposures.
Attachment B
QUESTIONS AND ANSWERS ON TSCA
INITIAL REPORTING REGULATIONS
Q. What is the purpose of this regulation?
A. After publication of the inventory, persons who intend to
manufacture any chemical substance not included on the
inventory must give EPA premanufacture notification. EPA will
use the other information reported to help set priorities and to
monitor chemical substances in the environment.
Q. How do these final reporting regulations compare with those
proposed on August 2, 1977?
A. Like the August 2 proposed regulations, these regulations require
reporting by plant site and production volumes for chemical
substances manufactured for commercial purposes in calendar
year 1977.
i:
-------
The criteria for "who must report" have been slightly modified,
but the number of firms required to report should be about the
same (an increase of 425 firms).
On the other hand, there are several modifications to reduce the
reporting burden to industry.
(1) The definition of intermediate has been modified to exclude
fleeting intermediates. Only intermediates which are actually
isolated or removed from the equipment in which they are
manufactured are to be reported.
(2) Production volumes may be reported in broad ranges, not
more specifically as proposed earlier.
(3) Importers are now required to report only bulk chemical
substances, and do not have to report the components of
articles, and
(4) The definition of "small manufacturers and importers" has
been changed from $100,000 total annual sales, 2,000 pounds
production, and one plant site, to $5 million total annual sales
and 100,000 pounds production of chemical substances.
Q. How many manufacturing firms will be required to report under
these regulations?
A. About 5400 firms will be required to report, or 8400 sites. This
compares with 4975 firms or 7400 sites included in Standard
Industrial Classification groups 28 and 2911 that were subject to
the reporting requirements as proposed in August. Thus the final
regulations are slightly more comprehensive than the August 2
proposal, requiring some 425 additional firms to report. Pulp and
paper mills, which were previously exempted, will probably be
required to report.
Q. What manufacturers and importers are required to report for the
initial inventory?
A. All manufacturers who meet the following criteria must report all
chemical substances at a plant site if:
(1) Thirty percent or more by weight of the products distributed
from the plant site during calendar year 1977 were products
within SIC groups 28 (Chemicals and Allied Products) or 2911
(Petroleum Refining Products), or
(2) The total pounds of reportable chemical substances manufac-
tured at the plant site during calendar year 1977 equal one
million or more pounds.
In addition, manufacturers must report any chemical substance
not reported under (1) or (2) that was manufactured in quantities
of 100,000 pounds or greater at a plant site during calendar year
1977.
The reporting requirements for importers are parallel to these,
except importers do not report by site.
13
-------
Q. When does the reporting period begin?
A. There are two reporting periods under the final regulations, one
for the initial inventory and one for a revised inventory. Only
manufacturers and importers may report for the initial inventory.
Processors may report for the revised inventory.
Reporting for the initial inventory will begin on January 1, 1978
and extend to May 1, 1978. Most manufacturers of chemical
substances, and importers of chemical substances in bulk form,
must report concerning chemical substances manufactured or
imported for commercial purposes during the calendar year 1977.
Manufacturers and importers may report concerning substances
manufactured since January 1, 1975.
Reporting for a revised inventory will begin upon publication of
the initial inventory. During this period, processors and users of
chemical substances for commercial purposes, and importers of
chemical substances as parts of mixtures or articles, may report
those chemical substances eligible lor, but not included on the
initial inventory. The reporting period will last seven months(210
days).
Q. When may persons who process chemical substances report?
A. Persons who only process a chemical substance, that is. who buy a
chemical substance to use as a raw material in manufacturing
another chemical substance, mixture, or article, may report for
the revised inventory during the seven-month period after
publication of the initial inventory. Processors may then report
any substance not included on the initial inventory. In an effort to
avoid duplicative reporting, processors are not subject to the
initial inventory.
Q. When will the inventory be published?
A. At the earliest, the initial inventory will be published in late 1978.
The revised inventory, based on additions from processors, users
and importers of chemical substances as part of mixtures and
articles, will be published in late 1979.
Q. When will premanufacture notification requirements begin?
A. Thirty days after publication of the initial inventory, any person
intending to manufacture or import in bulk form a chemical
substance not included on the inventory must submit premanufac-
ture notification for that substance. Thirty days after publication
of the revised inventory, no person may import a mixture
containing a chemical substance not included on the inventory.
EPA is still considering whether persons who import (some)
articles must report with respect to (certain) chemical substances
which comprise those articles.
14
-------
Q. How do the final regulations define "small manufacturer or
importer?
A. Any manufacturer or importer whose total annual sales are less
than $5 million qualifies as a small manufacturer or importer for
the purposes of the inventory. The $5 million sales criterion
applies to the company, its parent company, and all companies
owned or controlled by the parent company taken together. No
company is considered to be a "small manufacturer or importer"
wifh respect to any chemical which it produces or imports in
quantities of 100,000 pounds or more at one plant site.
This definition of small manufacturer may be used for the
inventory reporting regulations only. Future reporting rules
under Section 8 will reevaluate the burdens involved and the
definition of small manufacturer may be adjusted accordingly.
Q. How many firms qualify as "small manufacturers" under this
definition?
A. Approximately 4200 firms out of 5400 firms required to report (78
percent) will qualify as "small manufacturers" under these
regulations.
Q. What is the small manufacturer or small importer exempted from?
A. Small manufacturers and importers are not exempt from
reporting information necessary for completion of the inventory.
They must report at least the identities of the chemical substances.
Small manufacturers are not required to report separately for
each plant site. Small manufacturers and importers are also
exempt from reporting production volumes. However, no
manufacturer or importer is a "small manufacturer or importer"
with respect to the chemical substances produced in quantities
greater than 100,000 pounds at one plant site.
Q. What is the total of these regulations?
A. EPA estimates that the total cost for the industry of complying
with these reporting regulations will be $13 million.
Q. What chemical substances may be reported for the initial or
revised inventories?
A. Any chemical substance within the jurisdiction of TSCA which
was manufactured, imported, or processed for a commerical
purpose since January 1, 1975, may be included on the inventory.
Q. What chemical substances are excluded from the inventory?
A. The following chemical substances are excluded from the
inventory and premanufacture reporting requirements:
(1) Substances which are manufactured or imported for use solely
as a food, food additive, drug, cosmetic, or device, including
substances used solely as intermediates in the manufacture of
15
-------
those products. These substances are regulated under the
Federal Food, Drug, and Cosmetic Act.
(2) Substances manufactured or imported solely for use as a
pesticide. Chemical substances manufactured or imported for
use as an intermediate in the manufacture of a pesticide are not
themselves pesticides under the Federal Insecticide, Fungicide
and Rodenticide Act.
(3) Chemical substances manufactured or imported in small
quantities for use solely in research or development (any
substance manufactured in 1,000 pound quantities or less will
be presumed to be manufactured for research purposes).
(4) Any impurity.
(5) Any byproduct which has no commercial purpose.
(6) Other chemical substances that occur incidental to storage; or
upon end use of another chemical substance, mixture, or
article (such as chemical substances that may occur upon use
of flares or batteries; processing of curable plastic molding
compounds; application of paints; or upon dying a fabric, for
example), as provided in section 710.4(d).
Q. What information is entitled to confidential treatment?
A. Any piece of data submitted to the agency may be claimed as
confidential. This includes chemical identities.
Q. How will EPA protect confidential data?
A. EPA is in the process of developing procedures for handling
confidential data. A Confidentiality Task Force is investigating
the following: (1) physical security, (2) computer security, (3)
employee security (including those of contractors). Under TSCA,
there are strong penalities for employees who release confidential
data. These procedures will be effective before the initial inventory
is published. EPA has inspected Chemical Abstract Services, who
will be processing the report forms, and is satisfied that adequate
safeguards have been taken.
Q. Will the general public have access to information collected under
the inventory reporting regulation'.'
A. Yes. Copies of the inventory and the list of generic names for those
chemical substances whose identities are confidential will be avail-
able to the public. The inventory will contain only chemical
names, but other non-confidential information will be available
on request. EPA is working on ways to make all non-confidential
data readily available to the public. This includes data such as pro-
duction volumes, company names, and plant sites.
16
-------
Q. How can the public find out about chemical substances whose
identities are confidential?
A. Along with the initial inventory, EPA will publish a list of generic
names for those chemical substances whose identities are
confidential. Thus the public will have a general idea about the
kinds of chemical substances which do not appear on the
inventory because of entitlement to confidentiality. In response to
a Freedom of Information Act Request, EPA's Office of General
Counsel will make a confidentiality determination. If the claim is
validated, EPA will deny the request for information. If the claim
is not validated, the submitter will be informed of EPA's intention
to release the data to the public thirty days prior to its release.
17
-------
-------
-------
-------
-------
_ o
._ 2 -n
§ O •"
> C a
™ 2 m
3 o
I H
p
h
£ o
co X
CO O
CO
H§
$2
•n 2
O °
S S5
m
> d
I- jn
-D O
30 CO
O H
O m
H oo
O
Z
§§
O
O
c
iio
H
I
3D
D
O
CO
CO
CO
c
93
m >
2 O
gfg
W TO °
a Is
RS
-H 2
ii
>
o
m
2
O
------- |