PB-242 826
DRAFT ECONOMIC IMPACT ASSESSMENT FOR THE PROPOSED
TOXIC SUBSTANCES CONTROL ACT (S.776)
ENVIRONMENTAL PROTECTION AGENCY
JUNE 1975
DISTRIBUTED BY:
National Technical Information Service
U. S. DEPARTMENT OF COMMERCE
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,EPA 560/4-75-002
DRAFT
ASSESSMENT
1 i *
TOXIC
242 826
fr. . .- ^ ..'
-j:|««, |;r |w||;
' ' J ' "' ' "
U.S. ENVIRONMENTAL
Office of Toxic
!U ME 1075
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BIBLIOGRAPHIC DATA
SHEET
1. Report No.
4. Title and Subtitle
Draft Economic Impact Assessment for the Proposed Toxic
Substances Control Act S.776
~3. Keport Date
June 1975
I 6.
7. Author(B)
I 8. Performing Organization Kept.
No.
9. Performing Organization Name and Address
Office of Toxic Substances
Environmental Protection Agency, 401 "M" Street, SW
Washington, DC 20460
[10. Project/Task/Work Unit No.
_NA
111. Contract/Grant No.
NA
12. Sponsoring Organization Name and Address
(same as No. 9)
113. Type of Report & Period
Covered
14.
15. Supplementary Notes
16. Abstracts
The draft report estimates the direct costs to industry associated with the
implementation of the principal provisions of the proposed Toxic Substances Control
Act (S.776). The annual direct costs are estimated to be between $78.5
and 141.5 million. About two-thirds of these costs are shown to be attributable
to the areas of premarket screening and regulatory actions, with about one-third
attributable to the requirements concerning industrial testing and reporting.
17. Key Words and Document Analysis. 17a. Descriptors
Economic Analysis, Chemical Industry, Federal Regulation
17b. Identifiers/Open-Ended Terms
Economic Impact, Toxic Substances Control, Costs of Regulation of Chemicals
17c. 07 Chemistry (Organics and Inorganics; chemical industry)
05-C Economics (Impact of Regulation of Chemicals on Industry)
05-D Law (Toxic Substances Control Act)
17c. COSATI Field/Group
18. Availability Statement
Release unlimited
FORM NTis-38 (REV. io-73) ENDORSED BY ANSI AND UNESCO.
19.. Security Class (This 121. No. of Pages
Report)
UNCLASSIFIED
20. Security. Class (This
Page
UNCLASSIFIED
THIS FORM MAY BE REPRODUCED
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EPA 560/4-75-002
DRAFT ECONOMIC IMPACT. ASSESSMENT FOR
THE PROPOSED TOXIC SUBSTANCES CONTROL ACT (S.776)
Office of Toxic Substances
Environmental Protection Agency
Washington, DC 20460"
June 1975
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PREFACE
In recent months many requests have been received from Federal
agencies, Congressional staffs, and other organizations for an estimate
of the economic impact of the proposed Toxic Substances Control Act.
Given the complex structure of the chemical industry, the uncertainties
as to the nature of the regulations which would be promulgated to implement
the Act, and the difficulty of predicting the chemical problems of the
future, any such estimate must be very uncertain at best. Nevertheless,
an attempt has been made to develop an economic assessment which will be
helpful in identifying the types and severity of the impacts that are
likely to be associated with the legislation.
This draft Report sets forth very preliminary estimates of the
direct costs to industry that are likely to result from implementation
of the principal provisions of the legislation. While S.776 has been
used as the basis for the estimates, many of the observations in the
draft Report should be applicable to other versions of the pending
legislation as well. However, it must be emphasized that most of the
cost estimates, and particularly the estimates concerning premarket
screening and regulatory actions, are highly speculative. The draft
Report also includes a few observations concerning indirect costs to
industry, the impact of the legislation on employment concerns, the
impact on inflation, and international aspects.
The Office of Toxic Substances is interested in improving the
preliminary economic impact assessment presented in this draft Report
and would welcome comments on the estimates.
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TABLE OF CONTENTS
Preface i
Summary ' 1
The General Framework for-Estimating Economic Impact 4
Testing for Health and Environmental Effects (Section 4) 8
Premarket Screening of New Chemicals and New Uses (Section 5) 10
Regulatory Actions (Section 6 and 7) 12
Reporting Requirements (Section 8) 16
Fees for Processing Test Data (Section 26) 18
Appendix A: Sections 4, 5, 6, 7, 8, and 26 of S.776 19
ii
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SUMMARY
As summarized in Table 1, the direct costs to industry associated
with the implementation of the principal provisions of the proposed
Toxic Substances Control Act (S. 776) are estimated to range from about
$80 to $140 million annually. On the order of two-thirds of these costs
are attributable to the highly speculative areas of premarket screening
and regulatory actions, with almost all of the remainder associated with
.the somewhat more predictable, but still very uncertain, requirements
concerning industrial testing and reporting.
As a perspective for the estimated costs, sales for the sector of
industry that would be most directly affected by the legislation (i.e.
Chemical and Allied Products less food additives, cosmetics, drugs, and
pesticides) were about $72 billion in 1974, profits after taxes exceeded
$5.5 billion, and R and D expenditures were about $2 billion. If all
industrial sectors which could be affected by the legislation are considered,
the sales volume in 1974 was probably double this level, and the profits
and R and D expenditures were also much higher.
The estimated employment dislocations associated with regulatory
actions might result in the loss of one thousand or more jobs annually
out of the more than one million jobs in the Chemical and Allied Products
sector and twelve million jobs in the Chemical Processing sector. The
bulk of these displaced workers should be readily absorbed in the employment
pool of the affected sectors which has been expanding at a rate of tens
of thousands of new jobs each year. However, there will probably be
localized situations where opportunities for job mobility are limited
and the introduction of substitute products is not feasible.
In the international area, exports during 1974 of chemical products
(less food additives, cosmetics, drugs, and pesticides) exceeded imports
by $4.8 billion as the world demand for chemicals continued to grow and
tariff protection for the U.S. market remained at a relatively high
level for most chemical products. Given the strong international position
of U.S. industry, the costs associated with the legislation should not °
seriously affect the balance of payments position. Also, there is a
reasonable likelihood that some industrial countries will take steps
similar to those of the United States in this area of regulation.
The impact on the Wholesale Price Index, Consumer Price Index> and
the GNP Deflator of the costs to industry plus the costs of administering
the proposed law should be very small.
Indirect impacts on industry would include the cumulative effect of
regulations on the climate for innovation, changes in the scope and
direction of research activities, and possible shifts in production and
marketing patterns. Predictions in these areas are fraught with uncertainties
and have not been attempted.
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In addition, quantification of the foregone economic and social
benefits to society resulting from limitations on chemicals for which
there might not be adequate substitutes does not seem possible.
Finally, meaningful estimates cannot be made of the investment
losses and the employment dislocations which would be prevented through
regulatory actions against new products that are determined to be environmental
problems early in their lifetime rather than after major commercial
investments and the associated labor force are in place. Similarly, it
is not possible to estimate the additional administrative and technical
jobs which would be created by industry to comply with the legislation.
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Table 1: Preliminary Estimate of Annual Direct Costs to Industry
No. of Chemicals Affected Costs to Industry
(Millions of Dollars round*
Section 4 (Testing)
Existing Chemicals
New Chemicals -
Section 5 (Premarket Screening)
Administrative Costs of Noti-
fication of New Chemicals
Administrative Costs of Noti-
fication of New Uses
Delays due to Testing Require-
ments
Delays due to Industrial
Uncertainty
200
150
600
400
150
300
to nearest
4.5 -
3
2
1.5 -
7.5 -
2.5 -
$.5M)
8.5
6
.7.5
2.5
3
11.5
8.0
- 14.5
13.5 - 25
Section 6 (Regulation of Hazardous Chemicals)
Limitations on Selected Uses of
Important Chemicals & Restric-
tions on Minor Use Chemicals 3-4 23-31
Minor Actions Involving Labelling,
Quality Control, and Restric-
tions on Very Narrow Uses 10-20 4.5 - 9
27.5 - 40
Section 7 (Imminent Hazard)
Restrictions 1 every 3 years TO 20
Section 8 (Reports)
Annual Reports 1500-2000 4.0 - 10
Record Keeping No estimate 14 - 27
Health & Safety Studies
Preparing Bibliography 400-600 1 4
Retrieval of Studies 200-300 .5
19.5 - 41.5
Section 26 (Fees)
Test Data Submissions 250 .5
Total ' 78.5 - 141.5
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THE GENERAL FRAMEWORK FOR ESTIMATING ECONOMIC IMPACT
A preliminary estimate of the annual costs to industry which are
likely to result from compliance with the anticipated types of regulations
pursuant to the major provisions of the .proposed Toxic Substances Control
Act (S.776) is presented in this draft Report. Estimates at this time are
critically dependent on the assumption-s as to the nature of the implementing
regulations. The assumptions used herein are based on an interpretation
of the explicit legislative requirements in the context of the legislative
history that has been developed during the past four years. Also, the
following considerations have influenced the assumptions that have been
made:
-- Frequency and character of toxic chemical incidents and recent
trends in this regard.
-- Two years of intensive staff work by the Office of Toxic Substances
to provide a basis for implementation of this type of regulatory
authority.
-- Experience in administering reporting, testing, and regulatory
provisions of other environmental laws, and particularly . ;
the laws concerning pesticides and fuel additives.
Recent experience in developing approaches to the anticipation of
and response to chemical problems.
-- Advice of the National Academy of Sciences concerning test protocols
and decision-making related to*toxic chemicals.
-- Consultations with a number of chemical manufacturers concerning
implementation of this type of legislation.
-- The budgetary authorization level of about $11 million annually
(section 26a)J
The analysis centers on the costs to industry during years two
through six following enactment of Ihe legislation, using the 1975 price
index. In subsequent years the costs associated with some activities
should decline while others should increase. For example, the number of
1 While many of the factors bearing on regulatory activities directed
to pesticides are considerably different from the factors that
will affect simiTar activities directed to industrial chemicals,
the annual EPA budget of about $43 million for pesticides activities
gives some indication of the level of activities that might be
expected under the proposed legislation. For example, many
years have been required to register about 1,800 pesticidal
chemicals in 35,000 formulations. More than eight years have "
jeen required to develop registration guidelines setting forth
testing requirements. About two pesticidal chemicals are
cancelled each year. Finally, 40 chemicals will receive intensive
study during FY 1976.
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existing chemicals subjected to testing requirements each year should
decline as the backlog of existing chemicals is reduced. On the other
hand, the number of new chemicals subjected to test requirements each
year should increase as the number of promulgated standards for test
protocols covering chemical classes increases.
The costs of the legislation will be distributed across a broad
segment of U.S. industry. While the sector most directly affected will
be the Chemical and Allied Products sector less food additives, drugs,
cosmetics, and pesticides, a number of other manufacturing and processing
activities also involve chemical activities and could be affected by the
legislation. A very rough estimate is that the Chemical and Allied
Products sector less food additives, drugs, cosmetics, and pesticides
represents about one-half (by sales volume) of the total industrial
activities that could be affected by the legislation. Sales for the
Chemical and Allied Products sector less food additives, drugs, cosmetics,
and pesticides were $72 billion in 1974 and profits after taxes were
$5.5 billion. Overall sales in this sector increased by 70 percent from
1970 to 1974, and profit levels doubled. Continued growth of both sales
and profits are projected for the next decade.2
The inflationary impact of the legislation should be very small,
taking into account the annual costs to industry of $80 to 140 million,
the projected EPA expenditures of $11 million annually, and the new
costs to other agencies assisting in the administration of the law which
will probably initially be in thejnillions of dollars but could conceivably
reach considerably higher levels.
Quantification of the foregone economic and social benefits to society
resulting from limitations on chemicals for which there are no adequate
substitutes does not seem possible.
The complexities of the international chemical market make it very
difficult to quantify the effects of toxic substances regulation on
international commerce. U.S. chemical exports in 1974 were $8.8 billion
2
The estimates of past performance are based on information provided
by the Federal Trade Commission drawing on Quarterly Financial
Report for Manufacturing, Mining, and Trade Corporations. Hith
regard to future trends for the Chemical and Allied Products
sector, Chemical Week, January 8, 1975, forecasts an 11 percent
increase in profits during 1975, and Kline Guide to the Chemical Industry
(Charles H., Kline and .Company, Inc., Fairfield, New Jersey, 1974)
estimates an annual average growth rate for sales of 6.2 percent
through 1985.
Macroeconomic Aspects of Federal Pollution Control Programs,
Chase Econometrics, Inc., January 1975, concludes that an average
annual cost of about $20 billion for water and air pollution
controls during the 1973-1982 period would result in an average
annual rate of increase of 0.2 percent for the Wholesale Price
Index, 0.1 percent for the 6NP deflator, and 0.2 percent for the
Consumer Price Index.
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while imports were'about $4 billion.^ Given the growing world-wide
demand for chemicals, the current tariff structure for chemical imports,
and the well established position of U.S. industry in international
markets, the costs associated with this legislation should not have a
major impact on this currently favorable, balance of payments. Also,
Sweden and Japan have already enacted toxic substances legislation and
other countries, and particularly Canada, will probably adopt similar
measures should the United States take steps in this regard.
While the principal types of costs to industry are covered in the
analysis, some costs such as legal fees associated with court actions
and inconveniences caused by administrative inspections are not included.
Similarly, while the potential adverse impact on employment of regulatory
actions is considered, no attempt has been made to estimate the new
administrative and technical jobs within industry which will be required
to comply with the proposed law.
A number of potential indirect effects on industry of the legislation
have also not been addressed such as (a) the cumulative effect of regulations
on the climate for innovation, and subsequent changes in the scope,
direction, and payoff of R&D activities, and (b) possible shifts in
production and marketing patterns within U.S. industry resulting from
new regulatory requirements. Forecasts in these areas are
highly speculative at best. The regulatory experience in very narrow
industrial sectors, such as foods and drugs, may have some relevance but
does not provide a good basis for reaching sound conclusions when addressing
the entire chemical industry.
No attempt has been made to estimate what portion of the increased
costs to industry would be passed on to the consumer,! and only for
sections 6 and 7 has the portion that would be absorbed through tax
deductions and other financial arrangements been estimated.
Finally, the analysis does not address the environmental benefits
that would be derived from regulatory actions taken under the Act nor
the expected improvement in the cost/effectiveness of the regulatory
decisions that would .be taken under other authorities drawing on reporting
and testing information acquired under this Act. Similarly, no attempt
has been made to estimate the possible cost savings to industry and the
^Summary of U.S. Export and Import Merchandise Trade, Bureau of
Census, Foreign Trade Division, December 1974, tables 4 and 5.
average tariff for all chemical imports in 1973 was 1.8 percent.
The tariff for all chemicals less the benzenoid crudes and petroleum
was 4.6 percent. The tariff for finished chemicals and benzenoid
intermediates ranged up to 20 percent and higher, based on 1.7
rerits per pound plus 12.5 percent of the American selling price.
These figures were provided by the Chemical Divison of the U.S. ,
International Trade Commission, based on data from Schedule 4 of
the Tariff Schedule of the United States.
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prevention-of employment dislocations resulting from interception of
problem chemicals during the premarket phase and appropriate Governmental
action at that time to prevent environmental damage in contrast to the
current approach of taking corrective actions only after large commercial
investments and the associated labor force are in place.
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TESTING FOR'HEALTH AND ENVIRONMENTAL EFFECTS (Section 4)
Table 2: Estimated Costs of Testing Requirements
Existing Chemicals New Chemicals
A, No. of Chemicals Requiring
Limited Tests 180 .135
B. Average Cost per Limited Test
Requirement $10-20,000 $10-20,000
C. No. of Chemicals Requiring
Major Tests 20 15
D. Average Cost per Major Test
Requirement $200-400,000 $200-400,000
E. Portion of Tests that Would
Be Done by Industry in Absence
of Act 1/4 1/3
Total Costs $4.4 - 8.7M $2.9 - 5.8M
[(A X B) + (C X D)] X (1 - E)
Section 4(a) clearly implies a selective approach in determining
which chemicals should require testing and in determining which tests
should be required. Test requirements will undoubtedly vary among
chemical classes and among chemicals of the same class depending on
available data. Determining factors as to the requirements will probably
include contemplated uses and likely exposure patterns, anticipated
market volume, physical and chemical properties of the chemical, and
existing health and environmental effects data.
Test requirements for most of the chemicals (estimated to be 90
percent) that will be selected are anticipated to be limited, involving
a mix of modest tests for each cHlmical. While the costs will vary, the
current estimate is that the average cost will be on the order of $10-
20,000 per chemical. The physical and chemical properties and chemical
stability of .. compound can frequently be ascertained from simple and
inexpensive tests costing about $500. Acute animal toxicity tests by
various routes cost on the order of $1,000 each. Subacute testing, if
required, is considerably more expensive, about $15,000. Whether
results of certain- mutagenicity tests, which probably will cost about
$2,000 per compound could be a reliable indication of carcinogenicity is
an area of active investigation. Relatively inexpensive environmental
fate tests will also be important in some cases.
The remaining ten percent will be subjected to more extensive
testing. A typical example might be to require, in addition .to the
limited tests described-above, selected long-term chronic effects tests .
which could bring the total to $200,000 or more per chemical. In some
cases the costs would be still higher; in other cases, somewhat lower.
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The total projected costs of testing range between $7.3 million and
$14.5 million, while the estimated R and D expenditures of the chemical
industry in 1973 were $2.1 billion with R and D expenditures predicted
to be $2.7 billion in 1975.5 Thus, on a national basis the incremental
costs to industry seem minimal, between 0.3 and 0.5 percent of the
overall R and D budget. However, depending on how these costs are
distributed within industry, the cost impact of specific test requirements
could in some cases be quite significant for the affected firms.
A related concern is the present limitations on available qualified
scientists and facilities to carry out test requirements. .As testing
expands, special efforts will be needed to insure that a high quality
approach to testing is preserved.
h973 Estimate from "Twenty-percent Increase in Energy Activity
Paces Industry Research and Development Spending in 1973," Science
Resource Studies Highlights, National Science Foundation, NSF 74-
319, December 4, 1974. 1975 estimate provided by Chemical Meek.
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PREMARKET SCREENING OF- NEW CHEMICALS AND NEW USES (Section 5)
Table 3: Estimated Costs of Premarket Screening
Administrative Costs of Notification of New Commercial Chemicals
A. No. of New Chemicals 600
B. Average Administrative Cost per Chemical Notifi-
cation $3-4,000
C. Total Administrative Costs (A x B) $1.8 - 2.4M
Administrative Costs of Notification of New Uses
A. No. of Significant New Uses that Are Reported 400
B. Average Number of Reporting Establishments for Each
New Use during First Year of Use 4
C. Average Administrative Cost per New Use Notification $1-2,000
D. Total Administrative Costs (A x B x C) $1.6 - 3.2M
Delays due to Testing Requirements
A. No. of New Chemicals Delayed 150 .
B. Average Delay Time 1 Year
C. Average R & D Investment in Each Chemical at Time
of Delay . $500K
D. Cost of Capital 10-15%
E. Total Costs (A x B x C x D) $7.5 - 11. 3M
Delays due to Industrial Uncertainties as to Governmental Actions
A. No. of New Chemicals Delayed 200
B. Average Delay Time 1/4-1/2 Year
C. Average R & D Investment in Each Chemical at Time
of Delay $500K
D. Cost of Capital 10-15%
E. No. of Significant New Uses, 400
F. Portion of New Uses Delayed by Industry 1/4
G. Average Delay Time 1/4-1/2 Year
H. Average R & D Investment in Each New Use at Time
of Del a" $50K
I. Total Costs [(A x B x C) + (E x F x G x H)] x D $2.6 - 7.9M
Administrative Costs of Notification of New Commercial Chemicals
It is assumed that firms will spend a considerable amount of time
consulting with EPA concerning new chemicals, and the administrative costs
to industry of these consultations are reflected in Table 3.
Administrative Costs of Notification of New Uses
it is assumed that firms will expend a smaller, but still significant,
administrative effort in the premarket notification process for each
significant new use. It is further assumed that on the average four
10
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i
manufacturers will be actively considering each new use during the first
few months and hence involved in the premarket notification process.
After this initial period, a new use presumably will be picked up in
the annual reporting requirement for all concerned firms.
Delays due to Testing Requirements
It is difficult to generalize the delays that are likely to result
from premarket testing requirements, or the costs of the delays. It
is assumed that a limited test requirement will delay commercialization
of a chemical by nine months, and a major test requirement three years.
Since 90 percent of the affected chemicals will be subjected to limited
test requirements, the average delay time is estimated to be one year.
Testing usually is undertaken relatively early in the R & D cycle.
Nevertheless, substantial capital may have already been invested by the
time that testing is undertaken, both to develop the specific chemical
of interest and to rule out other candidate chemicals. The expenditures
in this regard will vary widely from product to product but should
only-infrequently exceed the $500,000 average investment assumed in
this analysis.
Delays due to Industrial Uncertainty as to Governmental Actions
In addition to its concerns over the new chemicals requiring
testing, industry may be hesitant to proceed with commercialization
of some of the other new chemicals until ascertaining how EPA will
react to the premarket notification.
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REGULATORY ACTIONS (Sections 6 and 7)
Table 4: Estimated Costs of Regulatory Actions
Limitations with Significant Impact (Section 6)
A. No. of New Chemicals Banned 2
B. R & D Investment for Each Chemical at Time of Ban $3M
C. Percentage of R & D Investment Recoverable 20%
D. Cost of Banning. New Chemicals [A x B x (1 - C)] $4.8M
E. No. of Minor Use, Existing Chemicals Banned . 1
F. No. of Manufacturers Involved with Each Minor-Use Chemical 4
G. Investment of Each Manufacturer $5M
H.' Percentage of Investment Amortized at Time of Ban , 50%
I. Percentage of Remaining Investment Recoverable through
Recovery of Land, Facilities, and Equipment 25%
J. Percentage of'Remaining Investment Recoverable through
Tax and Other Financial Arrangements . 25%
K. Costs to Manufacturers of Banning Existing Chemicals .
E x F x G x [(1 - H) - (1 - H)(l - I - J)] $5M
L. Costs to Suppliers (.5 x K) $2.5M
M. Costs to Processors (.5 x K) . $2.5M
N. Total Costs of Banning Minor Use, Existing Chemicals
(K + L + M) $10M
0. No. of Actions Limiting Uses of More Significant Existing
Chemicals i 1
P. No. of Manufacturers Involved in Each Action 8
Q. Investment of Each Manufacturer in Each Chemical $20M
R. Percentage of Overall Investment Affected by Each Action 20%
S. Percentage of Investment Amortized at Time of Action 50%
T. Percentage of Remaining Investment Recoverable through
Recovery of Land, Facilities, and Equipment 25%
U. Percentage of Remaining Investment Recoverable through
Tax and Other Financial Arrangements 25%
V. Costs to Manufacturers of Limiting Uses
0 x P x Q x R x [(1 - S) - (1 - S)(l - T - U)] $8M
W. Costs to Suppliers (.5 x V) $4M
X. Costs to Processors (.5 x V) $4M
Y. Total Cosob of Limiting Uses (V + W + X) $16M
Z. Costs of Limitations on 4 Chemicals
(D + M + Y) . $30.8M
AA. Range of Costs for 3 to 4 Chemicals $23.1 - 30.8M
Limitations with Lesser Impact (Section 6)
A. No. of New Chemicals Banned 2
B. R & D Investment for Each Chemical at Time of Ban $500K
C. Percentage of R & D Investment Recoverable 20%
D. Cost of Banning New Chemicals [A x B x (1-C)] $800K
E. No. of Actions Limiting Uses of Minor Chemicals 2
F. No. of Manufacturers Involved in Each Action 4
G. Investment of Each Manufacturer $2M
H. Percentage of Overall Investment Affected by Each Action 20%
'?
J2
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I. Percentage of Investment Amortized at Time of
Action
J. Percentage of Remaining Investment Recoverable through
Recovery of Land, Facilities, and Equipment
K. Percentage of Remaining Investment Recoverable through
Tax and Other Financial Arrangements
L. Costs to Manufacturers of Limiting Uses
' [E x F x G x H x [(1 - I)(l - J - K)]
M. Costs to Suppliers (.5 x L)
N. Costs to Processors (.5 x L)
0. Total Costs of Limiting Uses (L + M + N)
P. No. of Labelling Actions
Q. No. of Manufacturers Affected by Each Action
R. Cost for Each Manufacturer
S. Costs of Labelling Actions (M x N x 0)
T. No. of Quality Control Actions
U. No. of Manufacturers Affected by Each Action
V. Costs for Each Manufacturer
W. Costs of Quality Control Actions (T x U x V)
X, Costs of 10 Regulatory Actions (D + 0 +.S + W)
Y. Range of Costs for 10 to 20 Actions
50%
25%
25%
$800K
$400K
$400K
5
10
$20K
1
10
$100K
Imminent Hazard (Section 7)
1 every
A. No. of Existing Chemicals Banned
B. No. of Manufacturers Affected by Each Action
C. Investment of Each Manufacturer
D. Percentage of Investment Amortized at Time of Ban
E. Percentage of Remaining Investment Recoverable through
Recovery of Land, Facilities, and Equipment
F. Percentage of Remaining Investment Recoverable through
Tax and other Financial Arrangements
6. Costs to Manufacturers of Each Ban
B x C x [(1 - D) - (1 - D)(l - E - F)]
H. Costs to Suppliers (.5 x G)
I. Costs to Processors (.5x6)
0. Costs of Each Action (G + H + I)
K. Costs per Year (1/3 x 0)
3 years
6
$10-20M
50%
25%
25%
$15-30M
$7.5.-15M
$7.5-15M
$30-60M
$1.6M
$1M
$1M
$4.4M
,4-8.8M
$10-20M
The costs of regulatory actions will vary widely depending on the
chemical and the nature of the limitation. Conceivably, a single
regulatory action could have serious economic implications. However,
broad sweeping actions under this legislation are highly unlikely given
the requirements of Sections 6(c) and recent experience in dealing with
chemical problems. Regulatory actions are more likely to fall into the
following categories: restrictions on selected uses of certain existing
chemicals; requirements concerning labelling and quality control to
limit contaminants; and prohibitions on extremely hazardous new chemicals
and existing minor use chemicals that cannot otherwise be contained.
Judging from the frequency of toxic substance problems that have
arisen during the past decade, and taking into account the sharper
vigilance that will result from the legislation, it is estimated that
13
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there will be on the'order of three to four actions each year limiting
the uses of important chemicals or sharply restricting minor-use chemicals.
In addition there might be 10 to 20 minor regulatory actions involving
labelling, quality control requirements, or very narrow restrictive
uses. Finally, on rare occasions the use of the imminent hazard provision
might be appropriate.
The foregoing estimates suggest that on the order of 22 manufacturing
facilities, each representing an investment of from $2 to 20 million,
might be closed each year as the result of regulatory actions. The
number of employees at each facility will vary widely depending on the
product, the process, and the location and design of the facility. Most
of the affected facilities will probably be components of larger industrial
complexes with the number of employees ranging from 10 to 30 and in some
cases as high as 40 or 50. The remaining affected facilities will be at
individual locations with the labor force per facility somewhat higher
to allow for maintenance, security, and related tasks. .A reasonable
estimate is that .perhaps 500 employees might be employed at the 22
directly affected facilities. This compares with a total employment of
more than one million for this sector of industry.?
Estimates are much more speculative concerning the impact of regulatory
actions on the suppliers of raw materials for the affected manufacturers
and on the Chemical Process sector, which employs'more than 12 million
persons, as a result of the "ripple effect." At the one extreme a
supplier or a processor could be totally dependent on the continued
commercial viability of a single chemical manufacturing activity, and
regulatory actions affecting this activity could be crucial to his
business However, given the multiple interests of most suppliers and
processors, the flexibility of our market forces and the experience of
suppliers and processors in adapting to changes in marketing opportunities,
and the high innovative capacity of US industry, such a situation will
probably be unusual.
Since economic factors must be given appropriate weight in reaching
regulatory decisions under Section 6,* the likelihood that bans would be
promulgated on chemicals for which there are no substitutes does not
seem high. Also, it is assumed that in many cases the effective dates
of restrictions on chemicals will be set to minimize economic impact by
allowing time foi adjustments. In most cases, the supplier should be
?1970 employment figures show 1.045 million employees in the
Chemical and Allied Products sector and 12.659 million employees
in the Chemical Process sector (Chemical and Allied Products,
plus Food and Kindred Products, Paper and Allied Products, Petroleum
and Coal Products, Rubber Products, Stone-Clay-Glass Products,, and
rn*mary Metal Industries, Ferrous and Nonferrous): from American
Chemical Society, Chemistry in the Economy, Washington, DC 1973,.
page 490. Information provided by the Bureau of Labor Statistics
indicates a recent annual employment growth rate of about 1.7
percent for the Chemical and Allied Products sector and about
0.6 percent for the Chemical Process sector.
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able to sell his existing stocks and the processor should be able to
adapt his activities to different raw materials. Thus, it is estimated
that the principal impact of regulatory actions on the suppliers and
processors would be the adjustment costs of adapting to the new market
conditions resulting from regulatory actions, costs that might equal the
overall costs to the more directly affected manufacturers. In some
cases this cost estimate may be high; in other, cases, such as,in the
case of an imminent hazard, the estimate may be low. In Table 4, these
additional costs have been somewhat arbitrarily divided equally between
suppliers and distributors. By analogy with the cost estimates, the
employment dislocations due to the "ripple effect" should affect hundreds,
perhaps 500 or more, rather than thousands, of employees in the Chemical
Process sector.
The bulk of the workers displaced by regulatory actions should be
absorbed in the employment pool of the affected industrial sectors which
has been expanding at a rate of tens of thousands of new jobs each year.
However, there will probably be localized situations where opportunities
for job mobility are limited and the introduction of substitute products
is not feasible.
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REPORTING REQUIREMENTS (Section 8)
Table 5: Estimated Costs of Reporting
Annual Reports
A. Average No. of Chemicals To Be Reported. 1,500-2,000
B. Average No. of Reporting Establishments-per Chemical 25
C. Total No. of .Reports (A x B) - 37,500-50,000
D. Average Cost per Report $100-200
E. .Total Annual Cost of Annual Reports (C x D) $3.8-10M
Record Keeping
A. No. of Firms Requiring Major Systems 20-30
B. Average Cost of Installing and Operating a Major
System for Five Years $350-450K
C. No. of Firms Requiring Medium Systems 1,000
D. Average Cost of Installing and Operating
a Medium System for Five Years $35-55K
E. No. of Firms Requiring Minor Systems 10,000 ,
F. Average Cost of Installing and Operating a
Minor System for Five Years $10-20K
G. Portion of Costs which Would be Incurred
without Act 1/2
H. Five-Year Incremental Costs of Record Keeping
[(A x B) + (C x D) + (E x F)] x (1 - G) $71-134M
I. Annual Costs of Record Keeping (H x 1/5) $14.2-26.8M
Health and Safety Studies
A. No. of Chemicals To Be Searched for Inclusion in
Bibliography , 400-600
B. Average No. of Firms Searching Each Chemical 25
C. Average Cost per Search $100-250
D. No. of Studies To Be Submitted 200-300
E. Average Cost in Preparing Each Study for Submission $2,000
F. Total Annual Costs [(A x B x C) + (D x E)] . $1.4-4.4M
Annual Reports
The concept of "inventory reporting" set forth in section 8(a) of
the Conference Committee Working Print of November 25, 1974, has been
dropped. Thus, the intent of section 8(a) of S.776 appears to be a
selective approach to requiring reports on chemicals of interest. During
the five-year period under consideration, annual reports are envisaged
on about five times the number of chemicals which would be covered by
actions under sections 4, 6, and 7.
It is assumed that the number of chemicals subjected to annual
reporting requirements will increase from an initial level of 1000
discrete chemicals, including many in the same chemical classes, to a
plateau level of about 3000 chemicals during the sixth year, with the
average between 1500 and 2000. If ..there are 25 reporting establishments
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for each chemical, then an average of 35-50,000 reports can be expected
annually. ' Also, many reporting establishments will submit reports on
more than one chemical; thus, perhaps 5000 establishments will be involved
in the submission of the reports.
A relatively simple two-page Government form, together with appro-
priate instructions, for each chemical to be reported is envisaged.
Most, if not all, of the affected firms currently report related information
to the Tariff Commission. Thus, most of the required data should be
near at hand, with the estimated costs being $100-200 per report.2 In
some cases, initial costs may be higher as some firms reorient internal
data collection procedures. The costs may be lower from the outset for
other firms as shown in Dow's estimate. Also, reporting establishments
preparing a large number of reports at the same time should be able to
cut costs per report. In any event costs per report should decline as
industry becomes familiar with the requirements and as "no change"
reports begin entering the system.
Record Keeping
Some of the larger companies with extensive medical and sa-fety
programs may be required to expand current data analysis and retrieval
capabilities on a large scale. Many other companies may require more
modest investments. For the bulk of the small companies, a more systematic
use of file cabinets is envisaged.
The estimates are probably high since most responsible firms presumably
maintain extensive files in the areas of interest. Nevertheless, there
will be some expense in insuring that the files are centralized and in
an "inspectable" form.
Health and Safety Studies
Since the mandatory reporting requirements of S.776 appear infeasible,
it is assumed that they will be modified to give the Administrator
discretionary authority in this area. Based on this assumption, the
number of chemicals of interest is keyed to the number of chemicals
which would be subjected to regulations under sections 4, 6, and 7.
estimated cost is higher than the $40 estimated by Dow Chemical,
USA, in its letter of April 1, 1975, to Senator Tunney to take into
account special problems of small business and of overhead costs
involved in data compilation.
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FEES FOR PROCESSING TEST DATA (Section 26)
It is assumed that the fee would be waived for 100 of the 350
submissions of test data in hardship cases, with particular attention to
small business. An average fee of $2,000 would be required for the
other 250 submissions.
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APPENDIX A: Sections 4, 5, 6, 7, 8 and 26 of S.776
Standards for Test Protocols
Section 4:
. (a) GENERAL -- If the Administrator determines that '
(1) a chemical substance may present an unreasonable risk to
health or the environment;
(2) there is insufficient data upon which to conclude that
such a risk does in fact exist or not exist; and
(3) testing of such substance would assist in making such a
determination,
then he shall, by rule, prescribe standards for a test protocol for such
substance. Whenever such standards are proscribed, the Administrator
shall require, in accordance with subsection (b)(3) of this section,
that one or more persons formulate a test protocol for such substance,
in accordance with such standards, and perform the tests required by
such protocol. .
(b) STANDARDS --
(1) In prescribing the standards for test protocols, the
Administrator shall require that information pertaining to all
relevant factors with respect to the applicable chemical
substance be developed. Such factors include --
(A) the effects of such substance on human health, and
the magnitude of human exposure; and
(B) the effects of such substance on the environment, and
the magnitude of environmental exposure.
(2) Standards for test protocols shall require that such
protocols be formulated in accordance with those standards and
may require that tests be performed, in accordance with those
protocols, for carcinogenicity, mutagenicity, teratogenicity,
acute toxicity, subacute toxicity, chronic toxicity, cumulative
properties, synergistic properties, clinical effects, epidemiological
effects, ecological effects, and any other effects of such
substance which might cause unreasonable risk to human health
or the environment.
(3) A rule prescribing standards for a test protocol for a
chemical substance shall require that any test contained in a
test protocol for such substance which is formulated in
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accordance with such standards shall be performed by any
-person or governmental entity which is a manufacturer, processor,
or importer of such chemical substance.
(c) PERFORMANCE OK TESTS
(1) The Administrator may by rule permit two or more persons,
who are required -to test under a test protocol formulated in
accordance with standards prescribed by him, to designate one
such person or a qualified and independent third party to
perform such testing pursuant to a cost-sharing arrangement.
If the persons required to test are not able to agree upon a
designee within a reasonable time, or if the agreed-upon
designee is not acceptable to the Administrator, the Administrator
may order one or more of such persons, or may designate a
qualified and independent third party, to perform the required
testing. If the Administrator issues such an order, he shall
direct the persons who are thus exempted from the obligation
to perform tests to provide fair and equitable contribution
for the full cost of such testing, and of the cost, if any, of
formulating any test protocol, in an amount determined under
rules of the Administrator.
(2) Whenever the Administrator exempts a person from the
obligation to perform tests, he shall, if such exemption takes
effect during the reimbursement period for such data, order
such exempt person to provide reimbursement in the same manner
as if an exemption had been granted under section 5(f) of this
Act (unless the parties agree on the amount and method of
reimbursement).
(3) In any case in which a person provides contribution or
reimbursement in accordance with paragraph (1) or (2) of this
subsection or of section 5(g) of this Act, section 15 of this
Act shall not be construed to prevent such person from having
access to any data submitted as a result of the testing as to
which such contribution or reimbursement was provided.
(d) REPORTING -- A person required to perform any test required by
an applical ? test protocol shall submit the test data developed
pursuant to such test protocol and such protocol to the Administrator
promptly upon completion of such test. The Administrator may
provide for the submission of preliminary and other reports during
the course of such testing.
(e) NOTICE Upon the receipt of test protocol and test data
developed pursuant to it under this section, and subject to section
15 of this Act, the Administrator shall promptly publish a notice
of such receipt in the Federal Register. Each such notice shall
M) identify the chemical substance for which test data have
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been received, (2) list the uses or intended uses of such substance,
and other information specified by the Administrator by rule, and
(3) describe the nature of the test performed and the data which
were developed. Such data shall be made available by the Administrator
for examination by any person, except as otherwise provided in
section 15 of this Act.
(f) PROCEDURE -- Rules issued under this section (and amendment
thereto or repeals thereof) shall be promulgated pursuant to
section 553 of title 5, United States Code. In promulgating,
amending, or repealing any standard or other rule under this
section, (1) the Administrator shall give interested persons an
opportunity for the oral presentation of data, views, or arguments,
in addition to an opportunity to make written submissions, and (2)
a transcript shall be made of any oral presentation.
Prcmarket Screening of Chemical Substances
»
Section 5:
(a) GENERAL -- Commencing 180 days after the.date of enactment of
'this Act, a manufacturer or importer of a new chemical substance
(other than a mixture or a chemical substance covered by subsection
(b) of this section) shall notify the Administrator of the planned
manufacture or importation of such substance at least 90 days in
advance thereof. When providing such notice, such manufacturer or
importer shall submit to the Administrator the information referred
to in section 8 of this Act insofar as it pertains to such substance.
If in the judgment of the Administrator, such a substance does not
present an unreasonable environmental or human health risk, he may
reduce the number of days after submission of such information
during which manufacture or importation may not occur. The Administrator
shall give priority attention to a chemical substance with respect
to which information is received indicating that serious economic
or other hardships are likely to result if there is any unnecessary
postponement of manufacture or importation.
(b) SUBMISSION OF DATA
(1) After the effective date of test standards issued under
section 4 of this Act, any manufacturer or importer of a new
chemical substance which is covered by such standards, and who
first manufactures or imports such substance after such date,
shall submit to the Administrator (in lieu of the information
required in subsection (a) of this section), at least 90 days
prior to such manufacture or importation, the test data developed
in accordance with such standards, and the applicable information
referred to in section 8 of this Act which,pertains to the
intended use or distribution of such substance.
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(2) The Administrator shall promptly publish (subject to
section 15 of this Act) in the Federal Register the identity
of each such chemical substance, the use or distribution
intended, and a statement of the availability of any test data
or other information submitted.
(c) RULE -- If warranted by data available to him, o*- by the absence
of data, the Administrator may propose a rule under section 6 of
this Act with respect to a new chemical substance. If such rule is
proposed prior to the expiration of the 90-day period referred to
in subsection (a) or.(b) of this section, or during the extension
provided for in subsection (d) of this section, such proposed rule
shall apply (pending the outcome of administrative proceedings on
such proposal) to any subsequent manufacture or distribution in
commerce of such new chemical substance as if such proposed rule
were final.
(d) EXTENSION -- The Administrator may extend, for an additional
period beyond the 90-day period from the submission of required
information under this section, the date after which a new chemical
substance may be manufactured or imported for any particular use or
distribution. Such additional period may not exceed 90 days and
shall not be granted except for good cause shown. Notice of any
such extension, and the reasons therefor, shall be published in the
Federal Register. Such an extension shall constitute a final
action for purposes of judicial review.
(e) CLEARANCE -- Unless the Administrator proposes a rule with
respect to a new chemical substance, under section 6 of this Act,
within 90 days after the submission of information or data under
subsection (a) or (b) (or in the case of information submitted
under subsection (a) within such shorter period as the Administrator
may consider appropriate) or within such period as extended under
subsection (e), manufacture or importation of such new chemical
substance may commence. Nothing herein shall be construed to
prohibit the Administrator from promulgating a rule pursuant to
section 6 of this Act with respect to any chemical substance after
manufacture or importation has commenced, or from taking action
against any 'ubstance which is found to be an imminent hazard
pursuant to section 7 of this Act.
(f) EXEMPTION --
(1) The Administrator may exempt any person from the obligation
to submit test data under this section, if he determines that
the submission of test data by such person would be duplicative
of data previously received. Such an exempt person shall not
manufacture or import such new chemical substance prior to the
date of termination of the premarket screening period for
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which test data were submitted under this section. Any
chemical substance, or any manufacturer or importer thereof
referred to under the preceding sentence, shall be subject
to all the other provisions of this Act.
(2) If the Administrator, under paragraph (1), exempts any
person from submitting data under this section because of the
existence of previously submitted test data, and if such
exemption takes effect during the reimbursement period for
such data (defined in paragraph (3)), then, unless the. parties
can agree on the amount and method of reimbursement, the Administrator
shall order the person granted the exemption to provide fair
and equitable reimbursement (in an amount and subject
to conditions determined under rules of the Administrator) --
(A) to any person who previously submitted test data
on which the exemption was based, for a portion of the
costs incurred by him in complying with the requirement
under this section to submit such data, and
(B) to any other person who has been required under this
paragraph to contribute with respect to such data.
An order under this paragraph shall be considered final agency
action, for purposes of judicial review.
(3) For purposes of paragraph (2), the reimbursement period
for any previously submitted test data is a period --
(A) beginning on the earliest date (after submission
of such data) on which a person who previously submitted.
test data on which the exemption was based was no longer
prohibited from proceeding with the manufacture and distribution
in commerce of a chemical substance to which such data
applied, and
(B) ending two years after such date (or, if later, at
the expiration of a period after such date equal in
length to the period which the Administrator determines
was necessary to develop the previously submitted test
data).
(g) SIGNIFICANT NEW USE --
(1) A chemical substance may not be manufactured or imported
for a use which is identified by the Administrator in a rule
as a significant new distribution in commerce of such substance,
unless, at least 90 days prior to such manufacture or importation,
the person intending to manufacture or import such substance for
such use submits a notice of his intention to do so to the
Administrator. Any such substance shall be subject to all
other provisions of this section.
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(2) Any manufacturer or importer who proposes to distribute
in commerce a chemical substance for which notice may be required
under this subsection, shall attempt to ascot-tain from the
person to whom he distributes such substance (hereafter in
this paragraph referred to as "distributee") whether such
distributee proposes to distribute such substance for a use'
which would be a significant new use. If the distributee .
refuses or is unable to inform such manufacturer or
importer whether the proposed use would be a significant new
distribution in commerce, the manufacturer or importer shall
so inform the Administrator and shall inform the distributee
that such substance may be subject to this section. Such
distributee shall thereafter be treated, for purposes of this
section (including this paragraph), as the manufacturer of
such substance.
Hazardous Chemical Subst_anc_es_
Section 6:
(a) GENERAL -- If the Administrator determines.that a rule with
respect to a chemical substance is necessary to protect against an
unreasonable risk to human health or the environment, he may prescribe
such a rule under this section. Such a rule may consist of one or
more of any of the following types of requirements:
(1) Requirements (A) prohibiting .the manufacture, processing or
distribution in commerce of such chemical substance or (B)
limiting the amount of such chemical substance which may be
manufactured or distributed in commerce.
(2) Requirements (A) prohibiting the manufacture or distribution
in commerce of such chemical substance for a particular use or
(B) limiting the amount of such substance which, or regulating
the condition under which^such substances, may be manufactured
or distributed in commerce for such uses.
(3) P-quirements mandating that such chemical substance, or an
article containing such substance, be marked with or accompanied
by :lear and adequate warnings and instructions with respect
to its use or disposal, in such form and bearing such content
as the administrator determines to be appropriate.
(4) Requirements (A) that persons subject to requirements
prescribed under paragraphs (1), (2), or (3), make and retain
records and monitor or conduct tests 'necessary to assure their
compliance with such requirements; (B) that manufacturers and
processors of a chemical substances make and retain records of
the processes used to manufacture or process such substance;
and (C) that manufacturers and processors monitor or conduct
tests necessary to determine whether chemical substances
manufactured or processed by them are adulterated (within the
meaning of subsection (e) (2)), and retain records of such
tests. Any records or data required under this paragraph
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shall not be considered research data or process technology
for. purposes of section 13(b) of this Act.
The Administrator shall select the least stringent requirement
practicable consistent with the protection of human health and the
environment against unreasonable risks.
(b) APPLICABILITY --
(1) Jhe. applicability of any rule issued under this section
may be limited to specified geographic areas.
(2) The authority of the Administrator,, under subsection (a)
(2) of this section, to prescribe a rule prohibiting the
manufacture, processing, or distribution in commerce of a
chemical substance for a particular use includes the authority
to prohibit the distribution in commerce of a chemical substance
for a particular use in a concentration in excess of a level
specified in such rule.
(3) Rules limiting the amount of a chemical substance which
may be manufactured, processed or distributed in commerce or
limiting the quantity of such substance which may be manufactured,
processed or distributed for a particular use, shall provide
for assigning production, processing and distribution quotas
to the extent necessary, with respect to the chemical substance
whose manufacture, processing or distribution is limited
thereby. The permissible quota for each person who applies to
manufacture or process such substance or to engage in its
distribution in. commerce shall be determined in accordance
with criteria which the Administrator shall prescribe by rule.
Such criteria shall take into account all relevant factors,
including (A) effects on competition, (B) the market shares,
productive capacity, and product and raw material inventories
of the precursors of the chemical substance of persons applying
for quotas, (C) emergency conditions, such as fires or strikes,
and (D) effects on technological innovation.
(c) FACTORS -- In promulgating rules under subsection (a) of this
section, the Administrator shall consider all relevant factors,
including --
(1) the effects of the substance on health and the magnitude
and duration of human exposure to it;
(2) the effects of the substance on the environment and the
magnitude and duration of environmental exposure to it;
and
- (3) the benefits of the substance for a given use or uses
and the availability of less hazardous substances for the
same uses.
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(d) EFFECTIVE DAT!! The Administrator shall specify the effective
date ofany rule proposed under subsection (a) of this section.
Such date shall be as soon as feasible.
(e) QUALITY CONTROL
(1) If the Administrator has good cause to believe that a
particular manufacturer, importer, or processor is manufacturing,
importing, or processing a chemical substance in a manner
which permits or causes the adulteration of such chemical
substance. '
(A) he may require such manufacturer or processor to
submit a description of the relevant quality control
procedures followed in the manufacturing or processing of
such chemical substance and he shall take such other
actions as authorized by this Act; and
(B) if he thereafter determines by rule that such quality
control procedures are inadequate to prevent the adulteration
of such substance, the Administrator may order the manufacturer,
importer, or processor to revise such quality control
procedures to the extent which the Administrator finds
necessary to remedy such inadequacy.
(2) For purposes of this subsection, a cheniical substance is
adulterated if it or any precursor substance used or produced
in its manufacture or processing bears or contains any other
chemical substance or contaminant which itself or, in combination
with the chemical substance, poses or is likely to pose an
unreasonable risk to human health or the environment.
(f) PROCEDURE -- Rules issued under subsection (a) of this section
(and amendments thereto or repeals thereof) shall be promulgated
pursuant to section 553 of title 5 of the United States Code;
except that in promulgating any^such rule, amendment, or repeal (A)
the Administrator shall give interested persons an opportunity for
the oral presentation of data, views, or arguments, in addition to
an opportuni'" to make written submissions; (B) a transcript shall.
be made of any oral presentation; and (C) the Administrator shall
provide foi cross-examination to such extent and in such manner as
in his discretion he determines is necessary and appropriate in
view of the nature of the issue involved, the number of the participants
and the nature of the interests of such participants.
Imminent Hazard
Section 7:
An imminent hazard shall be considered to exist when the evidence
is sufficient to show that the manufacture, processing, or distribution
in commerce of a chemical substance or product containing such substance
will result in any unreasonable threat to human health or the environment,
prior to the completion of an administrative hearing or other formal
proceeding held pursuant to this Act; If the Administrator has reason
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to believe that an imminent hazard exists he may petition an appropriate
district court of the United States, or he may request the United States
attorney for such district to do so, to restrict the manufacture,
processing, or distribution in commerce of the chemical substance or
product responsible for the hazard, or. to take such other action as is
appropriate. The Administrator shall simultaneously, if he has not done
so, propose any regulation which may be warranted under section 6 of
this Act.
Reports
Section 8:
(a) GENERAL ' -
(1) The Administrator may, by rule, require any manufacturer,
importer, or processor of any chemical substance to maintain
such records, and to submit such reports to him annually, and
at such more frequent time as he may reasonably require.
Reports which the Administrator by rule requires may include
the following information:
(A) the common or trade name, the chemical identity, and
the molecular structure of each chemical substance for
which such report is required, insofar as known to the
person making the report or insofar as reasonably ascertainable;
(B) the categories or proposed categories of use of each
such substance, insofar as known to the person making the
report, or insofar as such are reasonably ascertainable;
(C) reasonable estimates of the amounts of each substance
manufactured, imported, or processed for each such use;
and
(D) a description of any byproducts resulting from the
manufacture, processing, distribution in commerce of each
such substance, insofar as known to the person making the
report or insofar as reasonably ascertainable.
(2) For purposes of this subsection, the term "byproduct"
means a chemical substance which is produced or results as a
consequence of the manufacture, importation, processing* or
distribution in commerce of some other chemical substance.
(b) INVENTORY -- The Administrator shall compile and publish a
listing of each chemical substance which any manufacturer, processor
or importer reports (under this section) is manufactured, processed
or imported into the United States. A chemical substance shall be
included in such listing as of the earliest date (as determined by
the Administrator) on which such substance was manufactured in or
imported into the United States.
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(c) SUBMISSION -- Any test data or other information required to be
developed pursuant to this Act shall ha submitted to the Administrator
promptly. The Administrator may require the submission of preliminary
and other reports during the course of any monitoring or testing.
(cl) RTCORDS -- Any person who manufactures, processes, or distributes
in commerce any chemical substance sh^ll maintain records of adverse
reactions to human health or the environment alleged to have been
caused by the chemical substance. Such records mey consist of, but
not be limited to,'consumer allegations of personal injury or harm
to health, reports of occupational disease or injury, and reports
or complaints of injury to the environment submitted to the manufacturer,
processor, or distributor in commerce by individuals or governmental
agencies.
(e) HEALTH AND SAFETY STUDIES Any person who manufactures,
processes, or distributes in commerce any chemical substance shall
report to the Administrator --
(1) all health and safety studies in progress on or initiated.
after the date of enactment of this Act, conducted by or for
the person; and .
(2) a list of all health and safety studies conducted by or
for such person 40 years prior to the date of enactment of
this Act. Such list shall be submitted to the Administrator
within 180 days after the date of enactment of this Act. The
Administrator, on the basis of the lists submitted, may request
submission of any study appearing on such list.
(f) COMMENTS -- Whenever the Administrator determines that such
action would be necessary to assist him to carry out his responsibilities
and authorities under this Act, he may, by publishing a notice in
the Federal Register, invite and afford all interested persons an
opportunity to provide information and comment in writing respecting
the health or environmental effects of a chemical substance. Such
an invitation and opportunity shall not be deemed a proceeding for
purposes of section 15(a)(2) of this Act.
Authorization for Appropriations
Section 26:
(a) There is authorized to be appropriated to the Administrator,
for purposes of carrying out this Act, not to exceed $11,100,000
for the fiscal year ending June 30, 1976, not to exceed $2,600,000
for the transitional quarter ending September 30, 1976, and not to
exceed $10,100,000 for the fiscal year ending September 30, 1977.
No lart of the funds so authorized ,to be appropriated shall be used
to construct any research laboratories.
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(b) The Administrator may, by rule, require the payment of a reasonable
fee from ony person required to submit test data under sections 4
and 5 of this Act to defray the cost of administering this Act.
Such rules shall not provide for any fee in excess of $2,500. In
setting such a fee, the Administrator shall take into account the
ability to pay of the person required to submit the data and the
cost of the Administrator of reviewing such data. Such rules may
provide for sharing such a fee, in any case in which the expenses
of testing are shared under section 4(ci) of this Act.
(c) Whenever the Administrator submits, in connection with this
Act, any budget requests, supplemental budget estimates, legislative
recommendations, prepared testimony for congressional hearings, or
comments on legislation to the President or to the Office of Management
and Budget, he shall concurrently transmit a copy thereof to the
Congress. No officer or agency of the United States shall have any
authority to require the Administrator to submit budget requests or
estimates, legislative recommendations, prepared testimony for
congressional hearings, or comments on legislation relating to this
Act to any officer or agency of the United States for approval,
comments, or review, prior to the submission of such recommendations,
testimony, or comments to the Congress.
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