xvEPA
United States
Environmental Protection
Agency
Office of
Toxic Substances
Washington DC 20460
December 1978
EPA- 560/3-78-001
Toxic Substances
Chemical Reporting and
Record-Keeping Authorities
under 15 Environmental and
Consumer Acts
TSCA
RCRA
FIFRA
CAA
FWPCA
SDWA
FD&CA
OSHA
FMS&HA
CPSA
FHSA
FFA
PPPA
HMTA
RSA
-------
3/5/2
697124 NTIS Accession Number: PB-291 685/6
Chemical Reporting and Record-Keeping Authorities Under 15 Environmental
and Consumer Acts
Wilhelm. Steven L.
Environmental Protection Agency, Washington, DC. Office of Toxic
Substances.
Report No.: EPA/560/3-78/001
15 Dec 78 266p
Languages: English
Journal Announcement: GRAI7910
NTIS Prices: PC A12/MF A01
This report is an indexed compendium of authorities to gather and
disseminate information which occur in the listed acts. It contains a
subject index to facilitate searching these acts for specific types of
autorities. It also contains an abridged text of the acts, edited for
clarity and brevity.
Descriptors: 'Legislation; 'Data acquisition; 'Reporting; Chemistry;
Records management; Catalogs; Hazardous materials; Requirements;
Information retrieval; Environments; Consumers
Identifiers: NTISEPAOTS
Section Headings: SB (Behavioral and Social Sciences-Documentation and
Information Technology); 88A* (Library and Information Sciences-Operations
and Planning); 68GE (Environmental Pollution and Control-General)
?logoAZ
-------
CHEMICAL REPORTING AND RECORD-KEEPING
AUTHORITIES UNDER 15 ENVIRONMENTAL
AND CONSUMER ACTS
Prepared by
Chemical Information Divisibn
Office of Program Integration and Information
Office of Toxic Substances
Environmental Protection Agency
December 15, 1978
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF TOXIC SUBSTANCES
FOREWORD
Effective integration of Federal information-gathering
efforts requires that staff and responsible program officers
be aware of the activities of other Federal agencies.
Because there was no available source describing the statutory
authorities under which various agencies gather data, the
Office of Program Integration and Information has developed
this compendium which abstracts information-gathering
authorities under 15 environmental and consumer acts.
Initially it was intended to be an internal reference
document for use by the staff of the Office of Toxic Substances
However, during the course of wide interagency review several
other programs expressed an interest in having a copy of the
final compendium. Accordingly, we have arranged for its
publication as an EPA report.
This compendium was developed to:
1. determine what record-keeping and reporting
authorities exist among various Federal statutes;
2. aid in avoiding duplicative record-keeping and
reporting requirements; and
3. ensure that the most efficient and effective
authority is used to obtain the desired information.
In this final form, the compendium includes an intro-
duction explaining the rationale, organization, and use of
the document; an annotated index; and an edited version of
the texts of the acts. It was designed to allow the user to
rapidly and conveniently survey these fifteen acts for
various types of information-gathering authorities.
Marilyn C. Bracken, Ph.D.
Deputy Assistant Administrator
for Program Integration and
Information
-------
Toxic Substances Control Act
Resource Conservation and Recovery Act
Federal Insecticide, Fungicide and Rodenticide Act
Clean Air Act
Federal Water Pollution Control Act
Safe Drinking Water Act
Federal Food, Drug and Cosmetic Act
Occupational Safety and Health Act
Federal Mine Safety and Health Act
Consumer Product Safety Act
Federal Hazardous Substances Act
Flammable.Fabrics Act
Poison Prevention Packaging Act
Hazardous Materials Transportation Act
Federal Railroad Safety Act of 1970
-------
INTRODUCTION
The Office of Program Integration and Information, of the
Office of Toxic Substances, Environmental Protection Agency, has
primary responsibility for coordinating the reporting and record-
keeping activities under the Toxic Substances Control Act (TSCA)
with those undertaken under other authorities. Section 10 requires
development of systems to facilitate exchange and dissemination of
toxic substances information gathered by Federal agencies. Subsection
9(d) charges the Administrator with "achieving the maximum enforce-
ment of this Act while imposing the least burdens of duplicative
requirements", and subsection 8(a) reads in part, "To the extent
feasible, the Administrator shall not require under paragraph (1),
any reporting which is unnecessary or duplicative". Currently the
Office of Program Integration and Information is involved in numerous
interagency efforts to coordinate TSCA information-gathering with
other Federal programs. This compendium was developed to serve as
a quick reference to the types of reporting and record-keeping
authorities contained in pertinent Federal, environmental and
consumer legislation.
Two caveats are in order. First, the language of these acts
has been freely edited in the interest of brevity and clarity. Very
little of the text has been left unchanged from the original
legislative language. For this reason, recourse to a true and
complete copy of the act is recommended in all instances.
Secondly, much of the statutory language has been omitted
entirely. In most cases, much of an act was not relevant to
information-gathering in general or was not relevant to toxic
or hazardous substances in particular. For example, the sections
of the Federal Food, Drug and Cosmetics Act relevant to "devices"
were omitted (because a device would rarely, if ever, be toxic
in nature) as were the sections of the Clean Air Act dealing with
automobile emission systems.* This compendium is not a general
index to these acts, but is, rather, restricted specifically to
record-keeping and reporting authorities. Other types of classes
are included only where it is necessary to understand the means
by which the agency informs itself on matters related to toxic
substances. In all cases the standard by which a provision was
included can be summarized as follows:
(A) (1) Will the agency possibly obtain significant infor-
mation through the operation of the provision? and
* Most significantly, the compendium does not contain as a
general class, regulatory authorities. Therefore, enforcement
provisions, civil penalty provisions, court injunction provisions
to restrain violations, and authorities to ban or regulate
production or use are generally not included.
(i)
-------
(2) Will the information be relevant to understanding
the hazards, occurrence, or dispersal of a toxic substance
in the environment? £r_
(B) Is the provision necessary or helpful to understanding
other provisions which serve the purposes described in (A)
above?
Immediately following this introduction we have included brief
descriptions of each of the classes of authorities which should
help to make the inclusions and omissions clear.
Whenever a substantial part of a section of an act was omitted,
a single three point ellipsis was used to indicate the omission.
When an entire section or more was omitted, an ellipsis of three
asterisks centered on the page was used. However, these conventions
do not apply to simple editing of the text which was usually done
without the use of ellipses.
There are four aids to facilitate use of this compendium.
The first, labeled Classes of Information-gathering Provisions,
enumerates and then describes individually the seventeen classes
of provisions (e.g., Subpoena authorities, Requirements to post
warnings or affix labels, Requirements to conduct tests) that
were culled from the acts. The second, labeled Authorities by
Class, indicates, in chart form, the number of provisions in each
act that are assigned to each class. This chart may be consulted
to determine whether an act contains any provisions in a particular
class. The next section, labeled Index to Statutes, lists and
annotates by class, and within class by statute, the relevant statutory
citations. Using this index, the user may easily scan all the acts
for a particular class of provisions, or scan a particular act for
all classes of provisions contained therein. Finally, in the texts
of the acts, roman numerals appear in the left margin to indicate
the precise location of each provision listed in the Index to
Statutes. These roman numerals correspond to the seventeen classes
listed in the section labeled Classes of Information-gathering
Provisions.
When it was possible, an entire section or subsection was assigned
to a class, and a roman numeral appears in the left margin next to
the section number or subsection letter. That roman numeral does
not occur again within that section unless used to highlight a
particularly important passage. In these cases, the user will have
to scan the entire section to find all the language relevant to the
indicated class. This is particularly important in understanding
the assignments made for the Federal Water Pollution Control Act
(FWPCA). Section 104 of FWPCA, for example, assigns the Administrator
seventeen major research projects and contains nine references to
cooperation with other entities in carrying out the asssigned
research. Accordingly, the entire section is assigned to classes
II and III. However, the research projects are not individually
assigned to classes II and III, and, therefore, do not appear separately
in the chart labeled Authorities by_ Class or the annotated index
mentioned above.
(ii)
-------
Whenever necessary for clarity, a unit smaller than a
subsection was assigned to a class. In these cases a roman
numeral appears in the margin at the appropriate line in the
text and the provision appears separately in the chart and
the annotated index. The provisions are not assigned to
sub-classes (e.g., VIII b or XII d) because annotation of
the Index to Statutes better serves this purpose.
With the exception of the last two, all of the seventeen
classes of information-gathering provisions are directly related
to information development or dissemination. The exceptions
are Category XVI, Relevant Definitions, and Category XVII,
Other Relevant or Precedent Clauses, which includes other sections
necessary for understanding the purposes or procedures of the
respective acts.
j
It was necessary at several points, to include explanatory
material not contained in an act. For example, other sections
are often referred to in the text of an act, but usually
only the section number is provided. Where it is helpful to
the reader to know what the referenced section deals with we have
included its title or a short descriptive phrase. Such editorial
inclusions or other substantially editorial passages are enclosed
in square brackets to identify them as such.
(iii)
-------
CLASSES OF INFORMATION-GATHERING AUTHORITIES
INFORMATION DEVELOPMENT
I. Requirements to conduct tests
II. Obligations and discretionary authorities of Federal
agencies to develop information/guidelines/standards/criteria
III. Obligations and discretionary authorities of Federal
agencies to cooperate with other entities in developing
information or for other purposes
IV. Required or discretionary review by an advisory committee
or public hearing
V. Requirements to monitor:
a) compliance or quality
b) exposure levels
c) health effects
RECORD-KEEPING
VI. Requirements established by rule to maintain records on:
a) operations and outputs
b) exposure levels
c) adverse health and environmental effects
d) administrative procedures
VII. General and unspecified record-keeping or reporting authorities
to be exercised "as necessary for the effective enforcement
of the Act"
INFORMATION-GATHERING
VIII. Authorities or requirements to inspect:
a) records
b) premises
IX. Subpoena authorities
X. Provisions to submit applications/petitions/certifications
or to obtain permits/registrations/exemptions/waivers
(iv)
-------
XI. Requirements to give notice or certification
XII. Requirements established by rule to submit reports:
a) on operations and outputs
b) on exposure levels
c) on adverse health and environmental effects
d) on required studies
e) as part of an application/petition/certification
XIII. Specific or general authorities to require submission of
records and reports in response to directed inquiries
(e.g., letters) without requiring either rules or subpoenas
Also see VII above
INFORMATION DISSEMINATION
XIV. Public availability of information and confidentiality
provisions
XV. Requirements to post warnings or affix labels
Also see X above
OTHER
XVI. Relevant definitions
XVII. Other related or precedent clauses
(v)
-------
DESCRIPTIONS OF THE CLASSES
I. Requirements to conduct tests
Most entries in this class are provisions authorizing requirements
to conduct tests on chemical substances for safety, efficacy or
environmental effects. Many such requirements occur in conjunction
with other activities, as, for example, in FD&CA subsection 505(b)
which requires the results of certain tests to be submitted with any
new drug application. Authorities to require medical examination
programs to detect adverse reactions are included under class V(c),
Requirements to monitor; health effects. Requirements to test effluent
discharges, ambient levels, and product or process compliance and/or
quality are all collected under class V, Requirements to monitor.
II. Obligations and discretionary authorities of Federal
agencies to develop information/guidelines/standards/
criteria
Several of the acts, FWPCA being a prime example, require the
agency to expend considerable resources developing certain infor-
mation necessary to implementation of the act. Some of these
requirements are straightforward research assignments for the agency,
while others occur indirectly as an adjunct to another activity
(e.g., the need to develop considerable new knowledge in establishing
effluent guidelines under FWPCA.) These research assignments
represent an extensive source of information on chemicals and
their occurrence in the market or environment. Accordingly, these
have been collected in class II.
III. Obligations and discretionary authorities of federal agencies
to cooperate with other entities in developing information
or for other purposes
With the exception of the Railroad Safety Act, each of the
fifteen acts contains at least one requirement for the lead agency
to cooperate with another specified agency or a general authority
.for discretionary cooperation with other agencies. The majority
of such provisions (which do appear in the compendium) deal with
interagency cooperation for the purpose of developing information,
guidelines, standards or criteria. However, some provisions
requiring or authorizing interagency cooperation are not relevant
to information development, or are not relevant to toxic substances,
and are therefore not included.
IV. Required or discretionary review by an advisory committee or
public hearing
Several of the acts provide for review of technical problems
by advisory committees, often at critical points in a decision
(vi)
-------
process. Because chese committees frequently may represent
significant avenues of input and analysis, the relevant statutory
provisions are collected here. In addition, some of the acts provide
for a similar use of public meetings and regional conferences. Such
public input mechanisms which inform the agency or aid the agency in
setting policy are also included. However, public hearings which occur
as a matter of course in rule-making or in response to a public petition
are often not included, as substantial technical input is less likely to
come from such gatherings. In all cases where the agency may subpoena
attendance, testimony, books or papers to the hearing, the provisions
for the hearing are included.
V. Requirements to monitor:
a) compliance or quality
b) exposure levels
c) health effects
The provisions in this class include monitoring by owners and
operators as well as by states or federal agencies. These authorities
can be differentiated into two classes: (1) authority to require
specific types of monitoring or monitoring in connection with other
specific requirements such as permits, and (2) general authority to
require monitoring. There is also one.act (CPSA) which contains an
apparent prohibition on requiring quality control monitoring programs.
Because this is directly relevant to monitoring authorities, it is also
included here.
VI. Requirements established by rule to maintain records on:
a) operations and outputs
b) exposure levels
c) health and environmental effects
d) administrative procedures
All authorities to require specific types of information to be kept
are collected into this class. "Administrative procedures" in (d),
above, usually refers to requirements that a state or other entity
maintain records on a process by which a decision or plan was reached or
implemented. These include records of the administration of a state
implementation plan (SDWA) and records of the development of a standard
(CPSA). Also collected in this class are a few special provisions
directly related to record-keeping authorities, such as the small
business exemption contained in TSCA section 8.
VII. General and unspecified record-keeping or reporting authorities
to be exercised "as necessary for the effective enforcement
of the Act"
Any provisions of the acts which authorize general record-keeping
or reporting requirements, without specifying what records are to
be kept or reports submitted, are collected under this class of
(vii)
-------
authorities. General regulation writing authorities are also
collected here because such authorities may include authority to
require records or reports.
VIII. Authorities or requirements to inspect:
a) records
b) premises
With the exception of FFA, each act contains some authority to
inspect premises or to obtain access to records for inspection and
copying. These two types of inspection authority are collected together
in this class, but differentiated by the annotations in the index so
that either type may be searched separately from the other.
IX. Subpoena authorities
Most provisions for an agency to obtain testimony or records by
subpoena or court order were extracted from the acts and appear in the
text and index. However, in cases where the authority is not related to
obtaining information on a toxic substance, it is not included. An
example of such a case occurs in subsection 202(b)(4) of the Clean Air
Act which authorizes the Administrator to subpoena records of automobile
manufacturers in regard to pollution control equipment on new vehicles
for the purpose of preparing an annual report to Congress. Since this
is not relevant to chemical regulation, it is not included. We have
also not included authorities for courts to subpoena information in a
judicial review proceeding as such powers are meant to inform the court,
and are not useful to an agency.
X. Provisions to submit applications/petitions/certifications
or to obtain permits/registrations/exemptions/waivers
It is almost always the case that permit-type processes are an
important means by which an agency gathers information. Several types of
permit and registration processes are included in this class: some
dealing with state implementation programs, while others apply to
individual owners or operators. Permit programs which do not deal with
toxic substances directly are not included. An example is section 404
of FWPCA which requires permits for discharge of dredged or fill
material into the navigable waters of the United States. This process
would almost certainly never develop information relevant to future
regulation of a specific toxic substance.
XI. Requirements to give notice or certification
Reporting requirements that are automatically triggered by an event
are collected into this class and termed generally as notices.
Important examples are the section 5 pretnanufacture notice of TSCA and
(viii)
-------
the section 13 premarket notice of CPSA. However, this class also
includes notices given to individuals as well as agencies. For example,
section 8 of OSHA requires manufacturers to notify workers of
excessive exposure, and section 14 of CFSA requires notification of
conformance with a consumer product safety standard to appear on a
product label to notify consumers of such conformance. Certain other
certifications of conformance are closely related to the latter example
and are also included. Some certification requirements, only
tangentially related to the idea of notification, are also included here
so that all certifications could be grouped together.
XII. Requirements established by rule to submit reports:
a) on operations and outputs
b) on exposure levels
c) on adverse health and environmental effects
d) on required studies
e) as part of an application/petition/certification
Any provision in an act which requires that a report be submitted
to an agency in response to a rule is included in this class if the
report or information contained in the report is related to chemical
regulation. Reports required of state agencies on their activities in
implementing an act are also included in this class. Eon-specific
authorities to require reports are included in class VII because such
authorities usually occur as a combined general authority to require
records and/or reports. Authorities to require reports from individuals
by letter are collected in class XIII.
XIII. Specific or general authorities to require submission of records
and reports in response to directed inquiries (e. ., letters)
without requiring either rules or subpoenas
Letter-writing authority is a complex issue and a determination
that such authority has been granted by Congress often requires consid-
eration of the legislative history as well as the act. No such detailed
efforts are implied by inclusion of a provision in this class. Rather,
clauses which seem to indicate such authority are collected here along
with authorities to require information by special order, which is a
closely related mechanism. The General Counsel of the lead agency
should be consulted to determine if letter-writing authority actually
exists under a specific act.
XIV. Public availability of information and confidentiality provisions
Provisions in the acts which affect the public availability
of information that is collected under any of the provisions appearing
in the compendium are collected in this class. Such provisions may, for
(ix)
-------
example, specify that certain information shall be public or that it
shall be subject to the confidentiality protections of another law such
as the Administrative Procedures Act. Provisions that require an agency
to develop or prepare information for public dissemination are also
included.
XV. Requirements to post warnings or affix labels
Any labeling requirement, or other provision relevant to a labeling
requirement, is included in this class. Requirements to post signs at a
workplace are also included because the intent is so closely related.
(Some of the provisions collected into class X deal with labels
certifying conformance with a standard. That class should be consulted
in regard to such labeling requirements.)
XVI. Relevant definitions
This section includes any definitions necessary to understand the
sections of the acts that are included in the compendium. Some of the
terms contained in this class may not be used in the compendium but the
definitions are helpful to understanding the scope and intent of the
act. This is particularly true of SDWA and FHSA.
XVII. Ocher related or precedent clauses
Any provision which could not reasonably be placed in one of the
other classes, but is necessary to understand the scope or application
of an act, is included here. These provisions are not referenced at the
related point in the text because it would not often be possible. This
class must be scanned for relevance to any sections of interest in an
act. As a matter of course, provisions dealing with imports and exports
are included here because such sections usually deal with application of
several parts of the act to imports and exports, and are therefore not
uniquely assignable to a single class of authorities. General regulation-
writing authorities may reasonably have been gathered into this class.
However, because the central theme of this compendium la record-keeping
and reporting authorities, such regulation-writing provisions have been
separately included in class VII, General and unspecified record-keeping
£T reporting authorities ^o be exercised "as necessary for the
effective enforcement of the Act."
(x)
-------
AUTHORITIES BY CLASS
TSCA
RCRA
FIFRA
CAA
FWPCA
SDWA
FD&CA
OSHA
FMSHA
CPSA
FHSA
FFA
PPPA
HMTA
RSA
I
4
-
2
2
_
—
6
2
1
3
_
1
_
_
—
II
10
8
3
13
13
2
12
7
5
6
1
_
_
5 •
2
III
10
7
4
3
5
2
3
4
_
1
1
1
_
1
-
IV
1
1
2
6
6
—
8
4
4
5
—
1
1
_
-
V
3
1
1
5
3
3
3
3
3
1
—
—
—
1
2
VI
5
6
-
1
1
2
7
3
4
1
1
_
_
_
1
VII
2
1
2
2
3
3
3
3
1
1
1
2
—
1
2
VIII
2
1
2
1
2
3
10
7
6
3
3
—
—
2
3
IX
1
1
1
1
2
_
_
1
2
1
—
1
—
2
1
X
2
3
4
10
5
3
9
1
2
1
1
-
-
3
1
XI
6
2
2
1
4
—
2
1
1
6
-
-
-
—
-
XII
5
3
5
8
2
—
13
4
2
1
-
-
-
1
1
XIII
1
1
1
1
1
—
4
—
—
1
-
-
-
2
-
XIV
7
2
4
4
3
1
6
4
5
4
2
1
-
4
-
XV
1
2
6
_
_
_
11
2
3
2
3
-
-
1
-
XVI
4
7
9
2
10
5
22
7
5
7
9
-
-
2
-
XVII
7
3
3
2
5
_
4
5
2
3
5
1
-
5
-
-------
INDEX TO STATUTES
!_ Requirements to Conduct Tests
TSCA
4
5 (a)
6(a)(4)
30
RCRA
FIFRA
5(d)
CAA
FWPCA
SDWA
FD&CA
OSHA
408(d)(l)(C)
408(d)(l)(D)
409(b)(2)(E)
505(b)
505(1)(1)
512(b)
6(b)(7)
20(a)(5)
testing requirements
submission of test data
authority to require tests to assure compliance
annual report to Congress on testing requirements
pesticide registration - submission of test results
experimental use permits - required studies
waivers - general authority of Administrator to
require tests
registered fuels - tests of health effects -
manufacturer
investigations of pesticide safety - petition for
a tolerance
studies of pesticide residue - petition for a
tolerance
studies of additive safety - petition to
establish safety
new drug applications - tests for safety and
efficacy
preclinical investigations of new drugs required
new animal drug application - tests
safety and health standards - medical exams and
other test requirements
Secretary's research projects - authority to
establish medical exam programs and other tests
(xi)
-------
FMS&Ri
101(a)(7) health and safety standards may require medical
exams and other tests
CPSA
7(d)(3)(A) developing a consumer product safety
standard - required tests
14(a) certificate based on tests
14(b) authority to require tests
FHSA
FFA
5(d) general authority to require tests of fabrics
PPPA
HMTA
RSA
(xii)
-------
II_ Obligations and Discretionary Authorities of Federal Agencies
_t£ Develop Information/Guidelines/Standards/Criteria
TSCA
4(b)(2)(A) prescribing test methodologies
4(b)(5) findings with respect to testing rules
4(g) developing testing standards - petition
5(a)(2) prescribing significant new use criteria
5(b)(4) list of chemicals - possible unreasonable risks
6(c) regulating chemicals - required statement
8(b) developing the Inventory
9(a) other agency regulation - developing information
10 research, development, collection, dissemination
and utilization of data
25 classification, storage and retrieval study
RCRA
1008(a) information and guidelines
3001(a) & (b) designating hazardous wastes and criteria
3002 standards applicable to generators
3003 standards applicable to transporters
3004 standards applicable to handlers
8001 research, demonstration, training and other
activities
8002 special studies
8003 coordination, collection and dissemination of
information
FIFRA
CAA
3(b) registration suspension - required considerations
20 research and monitoring - Administrator's duties
25(c)(6) authority to establish official names for
pesticides
103 several research projects for the Administrator
108 air quality criteria and control technology -
information development
111 standards of performance for new stationary sources
112 national emission standards for hazardous air
pollutants
153 ozone protection - studies by EPA
154 ozone protection - research and monitoring by
other agencies
211(b) registered fuels - development of test protocols
(xiii)
-------
307(d)(3)
309
319
120 of P.L.
95-95
403 of P.L.
95-95
FWPCA
104
105
115
301
303(d)(l)(A)
304
305
306
307
401(b)
403
516
SDWA
1412
1442
FD&CA
401
406
408
408 (j)
409(c)
409(d)
505(d)
508
702
702(d)
regulation of fuels and additives - required
considerations
factual background of any rule promulgated
Administrator's comments on other agency actions
establishment of national air quality monitoring
guidelines
Administrator's studies of several pollutants
several studies required of Administrator
research, investigations, training and information
research and development of pollution control
techniques
identifying in-place pollutants
developing effluent limitations
required effluent limitation survey by States
several requirements to develop criteria and
information
required water quality inventory by States
national standards of performance
toxic and pre-treatment effluent standards
designation of hazardous substances
supplying information and advice to other entities
developing ocean discharge criteria
required biennial report
large study of drinking water safety required
general authority to conduct studies and research
development of definition and standard for a food
tolerances for poisonous ingredients in food
tolerances for pesticides on raw agricultural
commodities
temporary tolerance for experimental permits
petition to establish additive safety - development
of conditions (standard of use)
Secretary may establish additive safety on his
own initiative i
new drug application - required findings
designating official names for drugs
general authorities necessary to conduct
investigations
developing information for the Commissioner of
Patents
(xiv)
-------
706(b)(5)
706(b)(7)
OSHA
4(b)(3)
6
6(b)(7)
20
20(a)(6)
22
24
FMS&HA
101(a)(7)
501
CPSA
7
9(b)
9(c)
27 (h)
27 (j)
FHSA
13 (b)
FFA
color additive safety - required considerations
color additives - tolerance
unnecessary duplication - interagency co-
operation
developing occupational safety and health
standards
worker medical exams - reimbursement by HEW
research and related activities
Toxic Substances List required
NIOSH - information development responsibilities
statistics - development
Secretary required to develop improved health
or safety standards
factual basis required for standards
determination of toxicity
research - medical examinations
several research projects for the Secretary
product safety information and research
consumer product safety standards
establishing standards - factual basis
establishing standards - required findings
consumer product testing and research facilities
biennial report to Congress
preparing results of investigations for public
availability
109(a) general information development authority
Secretary
109(d) research facilities and data centers
109(e) annual report by Secretary
304(a)(4) special studies by Board
304(a)(8) evaluation of safeguards
(xv)
-------
RSA
202(a) developing standards and regulations for railroad
safety
208(a) general authority to develop information, etc.
Cxvi)
-------
Ill Obligations and Discretionary Authorities of Federal Agencies
jzo Cooperate with Other Entities ±n. Developing Information
or for Other Purposes
TSCA
4(b)(2)(A)
6(c)
8(a)(3)(B)
9
9(d)
10
10(g)
26
27
RCRA
1006
3003
6003
8001(a)
8001(b)
8002(f)
8003(f)
FIFRA
6(b)
17 (d)
21(a)
25(a)(2)
CAA
103
323(e)
402 of P.L,
95-95
prescribing epidemiological studies
cooperative administration
small manufacturer definition
relationship to other Federal laws
cooperative enforcement
research
interagency information-coordination and
exchange committee
exchange of data
cooperative administration
development and evaluation of test data
integration with other acts
transportation of hazardous waste
cooperation with EPA
studies - cooperation with FEA, ERDA, and FPC
management program - coordination with other
acts
mining waste study - cooperation with Interior
Department
information collection and dissemination -
cooperation with States and local authorities
suspension actions - cooperation with USDA
international research and regulation -
Administrator's involvement
promulgating regulations - Secretary of
Agriculture's comments
general regulation-writing authority -
cooperation with USDA
the Administrator's research projects - co-
operation with other agencies
interagency cooperation with the National
Commission on Air Quality
establishment of Task Force on Environmental
Cancer and Heart and Lung Disease
(xvii)
-------
FWPCA
102(a)
104
105
115
501(b)
SDWA
1412
1442
FD&CA
702(c)
702(d)
707
OSHA
8(c)(3)
20
24
comprehensive program development - joint
investigations of pollution
several cooperative research projects
R&D - control techniques - grants
cooperation with Secretary of the Army
to remove in-place pollutants
use of other agency personnel
Administrator - cooperation with National
Academy of Sciences - maximum contaminant
level study
Administrator must provide technical assistance
to States
records of other agencies available to Secretary
supplying j information to the Commissioner of
Patents ',
developing tests and methods
general authority to use other agencies' resources
requiring records of exposures - cooperation with
EEW
several cooperative research or development
projects
statistics development - EJ3W and Department
of Labor
FMS&HA
CPSA
29
FHSA
10(b)
cooperation with States and with other Federal
agencies
development of import regulations (section 14)
cooperation with Secretary of the Treasury
(xviii)
-------
FFA
5(d)(2) general authority to cooperate with any unit
of local, State or Federal government, or any
individual
cooperation between Secretary and ICC
(xix)
-------
IV Required or Discretionary Review by_ an Advisory Committee
or Public Hearing
TSCA
4(e)
RCRA
3008(b)
FIFRA
6(c) & (d)
CAA
103(e)
109
117
165
323
FWPCA
104(a)(3)
104(a)(4)
303(c)(l)
401(a)(2)
515
SDWA
FD&CA
408(d)(3)
& (e)
409(f)(l)
512(c) & (e)
Interagency Testing Committee established
public hearing - enforcement actions
registraton suspension - public hearing and
scientific review
significant air pollution problem - regional
conference
air quality standards - scientific review
committee
hazardous air pollutant emission standards -
required public hearing
advisory committees
significant deterioration - permit hearing
National Commission on Air Quality
public investigations of pollution
research programs and proposals - advisory
committee review
water quality standards - public hearing
permit application - certification - public
hearing
certification - public hearing requested by
other States
Effluent Standards and Water Quality Information
Advisory Committee
petition for a pesticide tolerance - advisory
committee
additive safety - hearing
new animal drug - hearings and advisory
committees
(xx)
-------
512(m)(2),
(m)(4)(B)
706(b)(5)(C)
OSHA
6(d)
7
22
FMS&HA
101 (a) (1)
102(c)
103(b)
CPSA
10(c)
12(d)(3)
27 (a)
28
FHSA
FFA
17
PPPA
HMTA
RSA
animal feeds - hearings and advisory
committees
color additive safety - advisory committee
rule development - advisory committee
variance from a safety and health standard -
public hearing
National Advisory Committee on Occupational
Safety and Health and other advisory committees
establishment of NIOSH
standard development - advisory committee
standard development - public hearing
general authority to appoint advisory committees
accident investigation may include public hearing
petition for consumer product safety rule -
hearing
Product Safety Advisory Council
Product Safety Advisory Council may conduct
hearings
discretionary authority to conduct inquiries
and hearings
establishment of the Product Safety Advisory
Council
National Advisory Committee for the Flammable
Fabrics Act
technical advisory committee for general
purposes
(xxi)
-------
_V Requirements to Monitor:
a) compliance or quality
b) exposure levels
c) health effects
TSCA
6(a)(4) general authority to require monitoring
6(b) quality control
10(a) monitoring by Administrator
RCRA
3004(2) handlers - non-specific monitoring authority
FIFRA
20(b)&(c) National Monitoring Plan
CAA
implementation plans - monitoring by States
(ii) implementation plans - monitoring by owners
and operators
114(a)(1) general authority to require monitoring by
owners and operators
165(a)(7) significant deterioration - monitoring
requirements
319 establishment of national air quality monitoring
program
FWPCA
104(a)(5) monitoring water quality
308(a)(A) monitoring by owners and operators of point
sources
401(d) permit - required certification - monitoring
requirements
SDWA
1413(a)(2) monitoring by States required under public water
supply programs
1421(b)(1)(C) monitoring provisions required as part of State
underground injection program
1445(a) general authority to require monitoring
(xxii)
-------
FD&CA
409(b)(3)
512 (e) (2) (B)
512 (m)
OSHA
6(b)(7)
8(c)(3)
20(a)(5)
FMS&HA
101(a)(7)
202(a)
203
CPSA
7(a)(2)
petition to establish additive safety -
description of manufacturing controls
new animal drugs - quality control
animal feeds - quality control
safety and health standards - medical
examination program and monitoring requirements
records of required (6(b)(7)) monitoring
Secretary's research projects - authority
to require employers to monitor exposures and
conduct medical examination programs
health and safety standards may contain
monitoring requirements and medical examination
requirements
monitoring respirable dust required
x-ray monitoring of pneumoconiosis development
monitoring product quality prohibited
FHSA
FFA
RSA
106(a) monitoring safety procedures
206(a)(3) State monitoring of compliance with regulations
206(e) Secretary monitoring State efforts
(xxiii)
-------
VI Requirements Established by Rule to Maintain Records on;
a)
b)
c)
d)
TSCA
6 (a) (4)
8
8 (a) (2)
8 (a) (3)
8(c)
RCRA
3002(1)
3002(5)
3003(1)
3003(3)
3004(1)
3004(2)
FIFRA
CAA
(ii)
FWPCA
operations and outputs
exposure levels
adverse health and environmental effects
administrative procedures
records of processes
authority to require several types of records
several types of records
small manufacturer provisions
records of allegations of adverse reactions
generators - records of outputs
generators - manifest system
transporters - records of operations
transporters - manifest system
handlers - records of operations
handlers - manifest system
308(a)(A)(i)
SDWA
1413(a)(3)
U22(b)(l)(A)
(ii)
FD&CA
505(e)
505(i)(3)
505
authority to require reports of effluents
(records implied)
general authority to require owners and operators
of point sources to keep records
records of activities required of States
records of activities required of States
failure to maintain required records - withdrawal
of approval (new drug)
records required to establish efficacy of a
new drug
records of clinical experience - approved
new drugs
(xxiv)
-------
512(e)(l) &
Ce) (2) (A)
512 (j)
512(m)(4)
(B) (i)
OSHA
8(c)(2)
8(c)(3)
20(a)(5)
FMS&HA
103(c)
103(d)
303(a)
312(a)
CPSA
7(d)(3)(C)
FHSA
5(b)
new animal drugs - general authority to
require records
new animal drug research - general authority
to require records
animal feeds - records
general authority to require records of worker
deaths, injuries and illnesses
records of employee exposure required
Secretary's research projects - authority to require
employers to record exposures
records of exposure required
records of accidents and investigations
inspection of ventilation equipment - records
required map of mine
records of standards development process
guarantees (manifest system)
FFA
206(b) (3)
records kept by States
(xxv)
-------
VII General and Unspecified Record-keeping or Reporting Authorities
to be Exercised "As Necessary for the Effective Enforcement
£f the Act"
TSCA
general record-keeping and reporting authority
small manufacturer record-keeping and reporting
authorities
8(a)(3)
RCRA
2002(a)(l)
FIFRA
8 (a)
25(a)(l)
CAA
301
FWPCA
SDWA
FD&CA
308(a)(A)
402(a)(2)
501
1421(b)(l)(C)
1445(a)
1450
L
505(1)(3)
701(a)
general regulation-writing authority
general authority to require manufacturers to
keep records
general regulation-writing authority
general authority to require records and reports
of owners and operators
general regulation-writing authority
general authority to require records and reports
from point source operators
NPDES permits - record-keeping and reporting
requirements
general regulation-writing authority
general record-keeping and reporting authority
required as part of State program
general authority to require records and reports
general regulation-writing authority
clinical drug studies - general authority to
require records and reporting
general authority to require record-keeping and
reporting - approved new, drug
general regulation-writing authority
(xxvi)
-------
OSHA
8(c)(l) general authority to require records
8(g) (2) general regulation-writing authority
24(e) general authority to require reports from
employers
FMS&HA
103(h) general authority to require record-keeping
and reporting
general authority to require record-keeping
and reporting
general regulation writing authority
general authority to obtain reports and
records by regulation or subpoena
general authority to require record-keeping
by regulation
RSA
general record-keeping and reporting authority
of Secretary
206(b)(4) annual report by States - "such other infor-
mation as the Secretary may require..."
208(a) general authority to require record-keeping
and reporting
(xxvii)
-------
VIII Authorities or Requirements _to Inspect;
a)
b)
records
premises
TSCA
8(c)
RCRA
3007
FIFRA
8(b)
9
CAA
FWPCA
SDWA
308(a)(B)
311 (m)
1413 (a) (2)
1445 (b)(l)
FD&CA
505(e)
505 (j) (2)
510(h)
512(e)(2)(A)
& (D(2)
512(m)(4)(B)
(i) & (m)
(5) (B)
inspection and copying of records
general authority to inspect premises and
records
general authority to inspect premises and
records
authority to inspect records of certain types
authority to inspect establishments
authority to inspect records and monitoring
equipment and to sample emissions
authority to inspect premises and required
records of point sources
authority to inspect vessels
inspection authority required as part of public
water systems program
inspection provisions required as part of State
underground injection program
general authority to inspect records and premises
refusal to permit inspection of required records -
new drugs
inspection of records required on new drugs
inspection of drug producer's premises and records
new animal drugs - inspection of records
animal feeds - inspection of records
(xxviii)
-------
OSHA
702(e)
703
704
2(b)
8(a)
8(f)
8(g)(2)
18(c)(3)
FMS&HA
FFA
103 (a)
103(g)
103(1)
202 (g)
303(d)(l)
303(e)
CPSA
7(d)(3)(C)
16 (a)
16 (b)
FHSA
11
12
14
general authority to execute and serve search
warrants
general authority to inspect records relevant to
interstate shipments
general authority to inspect premises
Secretary's research projects - general
authority to inspect
general authority to inspect premises
general authority to inspect required records
authority to require periodic inspections
employee right to request an inspection
general regulation-writing authority - inspections
state plans must include inspection authority
broad authority to inspect mines
miner's right to an immediate inspection
especially hazardous conditions - weekly
inspection required
interim dust standard - authority to make spot
inspections
inspection before each' shift
inspection of each working section during each
shift
authority to inspect records of standards
development process
general authority to inspect premises
general authority to inspect records to determine
compliance
general authority to inspect premises
general authority to inspect records of
interstate shipments
obtaining samples of imports
109(c) inspections by Secretary
304 0>)(2) inspections by National Transportation Safety
Board
(xxix)
-------
RSA
206(e) general inspection authority
208(a) general inspection authority
208(c) general authority to inspect equipment and
records
Cxxx)
-------
IX Subpoena Authorities
TSCA
11(c) general subpoena authority
RCRA
3008(b)
FIFRA
6(d)
CAA
307(a)(1)
FWPCA
509(a)(l)
509(a)(2)
SDWA
FD&CA
OSHA
8(b)
FMS&HA
101(a)(3)
103(b)
CPSA
subpoenas - enforcement actions and public
hearings
registration suspension hearing - subpoena
authority
subpoena authority for several specific
purposes
water quality inventory - subpoena power
effluent limitations and process information -
subpoena power
requiring testimony and production of evidence
by court order
standard development - public hearing
accident investigation - public hearing
27(b)(3)&(4) general subpoena authority
FHSA
(xxxi)
-------
FFA
4(c)
PPPA
HMTA
109(a)
304(b)(l)
RSA
208(a)
general authority to subpoena testimony,
books, records and other writings
subpoenas by Secretary
subpoenas by National Transportation Safety
Board
general authority to issue subpoenas
(xxxii)
-------
X Provisions _tp_ Submit Applications/Petitions/Certifications or to
Obtain Permits/Registrations/Exemptions/Waivers
TSCA
4(g)
5(h)
RCRA
3004(7)
3005
3010(a)
FIFRA
3
4
5
7
CAA
(ii)
165
165(a)(8)
172(b)(6)
173
211
FWPCA
301(c) &
(g)-(D
401(a)
402
403(a)
petition for test standards
exemptions from notice and data requirements
standards applicable to handlers - permits
permits for treatment, storage or disposal of
hazardous wastes (handlers)
registration of generators, transporters and
handlers ("preliminary notification")
registration of pesticides
restricted uses - certification of applicators
experimental use permits
registration of manufacturing establishments
implementation plans - permit program
implementation plans - permit requirement
implementation plans - permit requirement
waivers from the requirements of section 111 -
encouraging innovation
waivers from hazardous air pollutant emission
standard
significant deterioration - pre-construction
requirements
permit - best available technology certification
by Administrator
non-attainment areas - permits required
non-attainment areas - permit requirements
registration of fuels and additives
applications for modifications of effluent
limitations
application/permit - required certification
NPDES - permits for discharges
NPDES - ocean discharge permits
(xxxiii)
-------
SDWA
1422(b)(l)(A)
FD&CA
408(d)
408(d)(2)
409(b)
409(1)
505
505(1)
510
512
706
OSHA
6(d)
FMS&HA
109(d)
202(b)(3)
CPSA
10
FHSA
3(d)
FFA
PPPA
HMTA
RSA
106(b)&(c)
107
206(a)
underground injection permits
application for approval of State underground
injection program
petition to establish a pesticide tolerance
petition for a tolerance - required certification
from USDA
petition to establish safety of a food additive
additives - exemptions for investigational use
new drug applications
new drugs - exemptions for investigational use
registration of drug manufacturers
new animal drug and animal feed applications
listing food color additives
application for a variance from a standard
registration of mines and operators
permit for noncompliance with interim dust
standard for permit
petition for consumer product safety rule
general authority to exempt substances from require-
ments of FHSA or its regulations
registration of transporters and container
manufacturers
application for exemption from the Act
State participation - required annual certification
(xxxiv)
-------
XI Requirements to Give Notice or Certification
TSCA
5
6 (a) (7)
6(b)(2)
7(b)(2)
8(e)
12 (b)
RCRA
3002(4)
3010
FIFRA
17 (b)
premanufacture notices - contents
notice of unreasonable risk
public notice of hazard
public notice of imminent hazard
notice of substantial risk
notice of intent to export
notifying handlers and transporters of waste
composition
hazardous waste handlers - notification
(registration with EPA)
human studies - notifying subjects of nature
of study
exports - notice to foreign governments
CAA
lll(j)(1)(A) waivers - notice of unusual emissions
FWPCA
311(b)(5) &
(c) (2) (D)
402(b)(8)
402(d)
oil and hazardous substances - notice of
spill
treatment works - changes in amounts or types
of introductions - notice
notice of each permit application received by
a State
SDWA
FD&CA
408(1)
505(i)(2)&(3)
OSHA
8(c)(3)
FMS&HA
103(c)
USDA certification of pesticide usefulness
clinical tests of drugs - required certifications
notice to employees of excessive exposures to
toxic materials
notifying miners of excessive exposure
(xxxv)
-------
CPSA
13(a) premarket notice required
14(a)(l) certification of conformance with a standard
15(b) notice of substantial product hazard
15(c) public notice of substantial product hazard
27(e) providing consumers with technical and
performance data by notice
14(c)(3) requiring certification of conformance on
a label
FHSA
(xxxvi)
-------
Requirements Established by Rule to Submit Reports:
a) on operations and outputs
b) on exposure levels
c) on adverse health and environmental effects
d) on required studies
e) as part of an application/petition/certification
TSCA
4(b)(l) reports of preliminary test data
5(b)(2)(A) testing data submission
5(d)(l)(A) contents of premanufacture notice
8(a)(2) illustrative list of information that may
be required
8(d) health and safety studies
RCRA
3002(6) generators - reports of outputs
3004(2) handlers - unspecified reporting (probably
regarding manifest system)
3005(b) reports of operations - permit application
FIFRA
3(c)(2) data in support of pesticide registration
5(d) experimental use permits - reports on required
studies
6(a)(2) submission of adverse effects information
7(c) establishment registration - information required
11(a) prohibition against requiring records or reports
of private applicators
CAA
(11)
165(a)(6)
172
211 (b) (2) (B)
air quality monitoring - reports by States
reports of emissions
permit application - general authority of State
to require information
waivers - required information and reports of
tests
permit process - required analysis of secondary
impacts
permit process - required analysis of primary
impacts
implementation plan - required inventory of
emissions
registration of fuels - required information
(xxxvii)
-------
FWPCA
305
308(a)(A)(ii)
SDWA
FD&CA
408(d)(l)
409(b)(2)(E)
505(b)
505(e)
505(1)(1)
505 (j)
510(j)
512(b)
512(d)
512(e) (2) (A)
&(j
512 (m)
OSHA
8(c)(2)
18(c)(7)
18(c)(8)
20(a)(5)
FMS&HA
103(d)
202(a)
CPSA
27(e)
required water quality study - biennial report
to Administrator
general authority to require owners and
operators of point sources to make reports
reports of investigations made on pesticides -
petition for tolerance
reports of investigations made on additives -
petition to establish safety
reports of investigations made on new drugs
to establish safety and efficacy
failure to make required reports - withdrawal
of approval (new drug)
reports of preclinical studies of new drugs
required
drug producers - semiannual list of products
special list of products
new animal drug applications - contacts
new animal drug applications - efficacy
new animal drug applications - general
authority to require reports
animal feeds - general authority to require
reports
authority to require reports on work-related
deaths, injuries and illnesses
State plans must include reporting requirements
State plans - general authority to require
States to submit reports
Secretary's research projects - authority to
require employers to report exposures
records of accidents and accident investi-
gations - required annual report
submitting dust samples and reporting working
conditions
requiring submission of technical and performance
data by rule
(xxxviii)
-------
FHSA
FFA
HMTA
106(b) annual report of hazardous materials handled
RSA
206(b)
annual certification by State - required report
(xxxix)
-------
XIII Specific or General Authorities to Require Submission of Records
and Reports in Response to Directed Inquiries (e.g., Letters)
Without Requiring Either Rules or Subpoenas
TSCA
8(c)
RCRA
3007(a)
FIFRA
7(c)(2)
records of allegations of adverse reactions
furnishing records
requesting shipping data from individual
manufacturers
CAA
FWPCA
308(a)(A)
SDWA
FD&CA
authority to require any information from
an owner or operator
authority to require reports, records and
other information
(i)
512(d)(2)
512 (m) (5) (A)
OSHA
FMS&HA
CPSA
27(b)(l)
obtaining copies of advertisements for a
particular drug
obtaining a quantitative ingredient list for
a particular drug
new animal drug - obtaining records and
reports by special order
animal feeds - obtaining records and reports
by special order
requiring reports and answers by special order
(xl)
-------
FHSA
FFA
PPPA
HMTA
109(b) general letter-writing authority for the
Secretary
304(b)(9) general letter-writing authority for Board
RSA
Cxli)
-------
XIV Public Availability of Information and Confidentiality
Provisions
TSCA
4(d)
5(b)(3)
5(d)(2)
5(d)(3)
5(g)
14
RCRA
3007(b)
8003(e)
FIFRA
6(d)
7(d)
10
public notice of receipt of testing data
public availability of test data
public availability of premanufacture notices
publication of notice
publication of list of premanufacture notices
received
statement of reasons for not taking action
disclosure of data
public availability of inspection data
required program for rapid dissemination of
information
scientific review of registration suspension -
report public
production data confidential
trade secrets and other protected information
prohibited acts - unauthorized use of
information
CAA
(ii)
114 (c)
307(a)(l)
FWPCA
308(b)
402 (j)
509
reports of emissions available to public
information from inspections - public
availability
fuels and additives - health effects studies
not confidential
public availability of subpoenaed information
confidentiality of information gathered during
an inspection
permit applications - available to public
confidentiality of subpoena information
(xlii)
-------
SDWA
1445(d)(l)
FD&CA
408(f)
510(f)
705(b)
708
OSHA
6(b)(7)
8(c)(3)
8(g)(D
15
FMS&HA
103(c)
103(d)
103(h)
312(b)
CPSA
7(d)(3)(C)
25(c)
28(c)
FHSA
4(h)
13
FFA
4(c)
confidentiality of trade secret information
acquired under the Act
confidentiality of most information collected
under the Act
pesticide tolerance petition - confidentiality
of data
drug producer - registration data
dissemination of information
general confidentiality provisions
confidentiality of worker medical exams
employee access to records of required
monitoring
authorization to publish any information
obtained under the Act
confidentiality of trade secrets
confidentiality of medical examinations
miner access to records of exposure
public availability of records of accidents
and investigations
Secretary may compile and publish majority
of data collected under the Act
confidentiality of mine map
public disclosure of information
records of standards development
public availability of information
proceedings of Product Safety Advisory Council
- public
unauthorized use of trade secret information
prohibited
imminent danger situations and general public
availability of data
confidentiality of trade secret information
(xliii)
-------
HMTA
106(b) transporters and container manufacturers -
registration information
107(a) safety analyses - data
304(b)(9) public availability of information submitted
to Board
306 public availability of information submitted
to Board
RSA
Cxliv)
-------
XV Requirements to Post Warnings or_ Affix Labels
TSCA
6(a)(3)
RCRA
general authority to require labeling
3002(2)
3003(a)(2)
FIFRA
3(c)(5)(B)
25(c)(3)
25(c)(5)
CAA
FWPCA
SDWA
FD&CA
301(o)
403
502
512(d)(l)(G)&
(e)(2)(C)&
(i)
512(m)(l)&
(m)(3)(D)&
(m) (4) (B)
(Hi)
601(a)
601(b)
OSHA
6(b)(7)
generators - labeling hazardous waste containers
transporters - labeling requirements
pesticide registration - submitting labeling
pesticide registration - approval of labeling
general uses and restricted uses - different
labeling
pesticide use inconsistent with labeling
prohibited
packaging and labeling standards
requiring a pesticide to be colored or discolored
sending copies of all labeling to a practitioner
definition of misbranded food - labeling
requirements
definition of misbranded drug or device -
labeling requirements
new animal drugs - labeling
animal feeds - labeling
cosmetics - labeling coal tar hair dyes
cosmetics - "misbranded" definition
safety and health standards - labeling require
ments
posting notice of employee protections and
obligations under the Act
(xlv)
-------
FMS&HA
health and safety standards must include
workplace warnings
109(a) required posting of orders and decisions
303(d)(1) posting danger signs as a result of inspections
CPSA
general authority to require labels
14(c) general authority to prescribe use and
form of labels
FHSA
2(p) general labeling requirements
3(b) special labeling requirements
3(c) exemptions from unnecessary labeling
FFA
PPPA
general authority to require labeling
(xlvi)
-------
XVI Relevant Definitions
TSCA
3(1)
3(6)
3(12)
26(c)
RCRA
1004(1)
1004(3)
1004(5)
1004(12)
1004(27)
1004(33)
1004(34)
FIFRA
2(e)(2)
2(e)(3)
2(n)
2(p)(2)
2(q)
2(x)
2(bb)
"Administrator"
"health and safety study"
"standards for the development of test data"
"category of chemical substances"
"Administrator"
"disposal"
"hazardous waste"
"manifest"
"solid waste"
"storage"
"treatment"
"certified applicator"
"private applicator"
"commercial applicator"
"ingredient statement"
"label"
"labeling"
"misbranded"
"protect health and the environment"
"unreasonable adverse effects on the
environment"
CAA
112(a)(1) "hazardous air pollutant"
171(1) "reasonable further progress"
FWPCA
306(a)(l) "standard of performance"
306(a)(2) "new source"
306(a)(3) "source"
311(a)(1) "oil"
311(a)(14) "hazardous substance"
502(11) "effluent limitations"
502(13) "toxic pollutant"
502(15) "biological monitoring"
502(18) "industrial user"
502(19) "pollution"
(xlvii)
-------
SDWA
1401(1)
1401(2)
1401(3)
1421(d)(2)
FD&CA
201(c)
201(f)
201(g)
201(1)
201 (k)
201 (m)
201(n)
201(p)
201(q)
201(r)
201(s)
201(t)
201 (u)
402
403
409
501
502
512 (d) (3)
601
OSHA
3(1)
3(8)
3(9)
3(10)
3(11)
3(12)
3(13)
FMS&HA
3 (a)
"primary drinking water regulation"
"secondary drinking water regulation"
"maximum contaminant level"
"underground injection"
"underground injection which endangers a
drinking water source"
"Department"
"food"
"drug"
"cosmetic"
"official compendium"
"label"
"labeling"
"misbranded"
"new drug"
"pesticide chemical"
"raw agricultural commodity"
"food additive"
"color additive"
"safe"
"adulterated food"
"misbranded food"
"unsafe food additive"
"adulterated drug or device"
"misbranded drug or device"
"manufacture, preparation, propagation,
compounding or processing"
"substantial evidence"
"adulterated cosmetics"
"Secretary"
"occupational safety and health standard"
"national consensus standard"
"established Federal Standard"
"Committee"
"Director"
"Institute"
"Secretary"
"imminent danger"
(xlviii)
-------
3(k)
3(1)
3(n)
CPSA
3 (a) (2)
3(a)(3)
3(a)(7)
12 (a)
13(b)
15 (a)
FHSA
2(d)
2(f)
2(g)
2(h)
2(k)
2(p)
2(q)
FFA
103(2)
103(3)
"accident"
"mandatory health or safety standard"
"Administration"
"consumer product"
"consumer product safety rule"
"risk of injury"
"private labeler"
"imminently hazardous consumer product"
"new consumer product"
"substantial product hazard"
"Commission"
"hazardous"
"toxic"
"highly toxic"
"corrosive"
"irritant"
"strong sensitizer"
"misbranded hazardous substance"
"banned hazardous substance"
"hazardous material"
"Secretary"
RSA
(xlix)
-------
XVII Other Related or Precedent Clauses
TSCA
2(b)
4(f)
6
8(a)(2)
12
13
RCRA
3003(4)
3008
8002(1)
FIFRA
CAA
12
17
110
112(c)
FWPCA
101
208 (b) (2) (K)
308(c)
402 (b)
SDWA
FD&CA
301
603
701
801
policy - development of data
receipt of test data - required actions
insufficiency of information
regulation of hazardous substances and mixtures
small manufacturer exemption
exports
imports
prohibited acts
enforcement provisions
studies - completion dates
administrative review and suspension of
registration
prohibited acts
application of act to imports and exports
State implementation plans
hazardous air pollutant - prohibitions
declaration of goals and policy
areawide waste treatment - disposal of pollutants
inspection, monitoring and entry by States
policy - no discharges of oil or hazardous
substances
NPDES permits - State programs
prohibited acts
cosmetics labeling - exemptions
general regulation-writing authority
imports
(1)
-------
OSHA
2(b)
8(d)
18
20(a)(5)
20 (d)
FMS&HA
103(e)
201
CPSA
12(a)
17
19
FHSA
3 (a)
4
10(b)
14
18
FFA
4(b)
PPPA
HMTA
101
104
105(c)
301
303
RSA
statement of purpose and policy
duplicative and excessive burden provisions
State jurisdiction and State plans
reimbursement of employer's monitoring costs
Secretary of HEW - responsibilities assigned
to NIOSH
burdensome or duplicative requirements - small
business considerations
interim standards - coverage
authority to proceed against an imminent hazard
application of the Act to imports
prohibited acts
designation of hazardous substances
prohibited acts
relevant to subsection 10(a)
imports
effect upon other Federal and State laws
criteria for a flammability standard
Title III
short title
designation of hazardous materials
certified containers
short title
establishment of National Transportation
Safety Board
Hazardous Materials Transportation Control
Act (repealed)
(li)
-------
PUBLIC LAW - 94-469 — October 11, 1976
"TOXIC SUBSTANCES CONTROL ACT"
FINDINGS, POLICY AND INTENT
SEC. 2.
XVII (b) Policy. — It is the policy of the United States that —
(1) adequate data should be developed with respect to the
effect of chemical substances and mixtures on health and the
environment and that the development of such data should be
the responsibility of those who manufacture and those who
process such chemical substances and mixtures;...
DEFINITIONS
SEC. 3.
As used in this Act:
XVI (1) "Administrator" means the Administrator of the
Environmental Protection Agency...
XVI (6) "Health and safety study" means any study of any effect
of a chemical substance or mixture on health or the environ-
ment or on both, including underlying data and epidemiclogical
studies, studies of occupational exposure to a chemical substance
or mixture, toxicological, clinical, and ecological studies of a
chemical substance or mixture, and any test performed pursuant to
this Act...
(12) "Standards for the development of test data" means
XVI prescription of —
(A) the —
(i) health and environmental effects, and
(ii) information relating to toxicity,
persistence, and other characteristics whfch
affect health and the environment, for which
test data are to be developed and any analysis
that is to be performed on such data; and
(B) as necessary to assure that the data are
reliable and adequate —
(i) the manner in which such data are to be
developed,
-------
TSCA - 2
(ii) specification of any test protocol or
methodology to be employed, and
(iii) other requirements necessary to provide
such assurance...
TESTING OF CHEMICAL SUBSTANCES AND MIXTURES
VI SEC. 4.
(a) TESTING REQUIREMENTS. — If the Administrator finds that --
(1) (A) (i) the manufacture, distribution in commerce,
processing, use, or disposal of a chemical substance
or mixture, or that any combination of such activities,
may present an unreasonable risk of injury to health
or the environment,
(ii) there are insufficient data and experience
upon which the effects of such manufacture, distribution
in commerce, processing, use, or disposal or any combina-
tion of such activities on health or the environment
can reasonably be determined or predicted, and
(iii) testing of such substance or mixture is
necessary to develop such data; or
(B) (i) a chemical substance or mixture is or will
be produced in substantial quantities, and (I) it may
reasonably be expected to enter the environment in
substantial quantities or (II) there may be significant
human exposure to such substance or mixture,
(ii) there are insufficient data and experience
upon which the effects of the manufacture, distribution
in commerce, processing, use, or disposal of such
substance or mixture or of any combination of such
activities on health or the environment can reasonably
be determined or predicted, and
(iii) testing is necessary to develop such data;
and
(2) in the case of a mixture, the effects which the mixture's
manufacture, distribution in commerce, processing, use, or disposal
or any combination of such activities may have on health or the
environment may not be reasonably and more efficiently determined
or predicted by testing the chemical substances which comprise
the mixture;
-------
TSCA - 3
the Administrator shall by rule require that testing be conducted
on such substance or mixture to develop data with respect to the
health and environmental effects for which there is an insufficiency
of data and experience and which are relevant to a determination
that the ... substance or mixture... does or does not present
an unreasonable risk of injury to health or the environment.
(b) (1) Testing Requirement Rule. — A rule under subsection
(a) shall include —
(A) identification of the chemical substance or
mixture for which testing is required under the rule,
(B) standards for the development of test data for
such substance or mixture, and
(C) with respect to chemical substances which are
not new chemical substances and to mixtures, a specification
of the period (which period may not be of unreasonable
duration) within which the persons required to conduct the
testing shall submit to the Administrator data developed in
accordance with the standards referred to in subparagraph (B)
above.
In determining the standards and period to be included in a rule
under subsection (a) above, the Administrator's considerations
shall include the relative costs of the various test protocols and
methodologies which may be required and the reasonably foreseeable
availability of facilities and personnel needed to perform the
testing required. Any such rule may require the submission of
preliminary data during the testing period.
(2) (A) The health and environmental effects for
which standards may be prescribed include carcinogenesis,
mutagenesis, teratogenesis, behavioral disorders, cumulative
or synergistic effects, and any other effect which may
present an unreasonable risk of injury to health or the
environment. The characteristics of chemical substances
and mixtures for which such standards may be prescribed
include persistence, acute toxicity, subacute toxicity,
chronic toxicity, and any other characteristics which may
present such a risk. The methodologies that may be prescribed
in such standards include epidemiologic studies, serial
or hierarchical tests, in vitro tests, and whole animal
tests, except that before prescribing epidemiologic studies
of employees, the Administrator shall consult with the
Director of the National Institute for Occupational Safety
and Health.
-------
TSCA - 4
(B) At least once each 12 months, the Administrator
shall review the adequacy of the standards for development
of data prescribed in rules under subsection (a) and shall,
if necessary, institute proceedings to make apptopriate
revisions of such standards.
(3) (A) A rule under subsection (a) respecting a chemical
substance or mixture shall require the persons described in
subparagraph (B) below to conduct tests and submit data
to the Administrator on such substance or mixture, except
that the Administrator may permit two or more of such persons
to designate one such person or a qualified third party to
conduct such tests and submit such data on behalf of the
persons making the designation.
(B) The following persons shall be required to conduct
tests and submit data on a chemical substance or mixture
subject to a rule under subsection (a):
(i) Each person who manufactures or intends
to manufacture such substance or mixture if the
Administrator finds that there are insufficient data
and experience as described in subsection (a)(1)(A)(ii)
or (a)(l)(B)(ii) above.
(ii) Each person who processes or intends to
process such substance or mixture if the Administrator
finds that there are insufficient data and experience
as described in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii)
above.
(iii) Each person who manufactures or processes
or intends to manufacture or process such substance or
mixture if the Administrator finds that there are
insufficient data and experience as described in
subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) with respect
to the distribution in commerce, use, or disposal of
such substance or mixture...
(5)... (C) the Administrator shall make and publish with
any testing rule the findings described in paragraph (1)(A)
or (1)(B) of subsection (a) above and, in the case of a rule
respecting a mixture, the finding described in paragraph (2)
of such subsection ...
XIV (d) NOTICE. — Upon the receipt of any test data pursuant to a
rule under subsection (a), the Administrator shall publish a notice
in the Federal Register within 15 days. Subject to section 14
[disclosure of data] each notice shall (1) identify the chemical
substance or mixture; (2) list the uses or intended uses and the infor-
mation required by the applicable standards for the development of test
data; and (3) describe the nature of the test data developed. Except as
otherwise provided in section 14, such data shall be made, available by
the Administrator for examination by any person.
-------
TSCA - 5
IV (e) PRIORITY LIST. — (1)(A) There is established a committee
to make recommendations to the Administrator respecting
the chemical substances and mixtures to which the Admin-
istrator should give priority consideration for the promul-
gation of a testing rule. In making such a recommendation,
the committee shall consider all relevant factors, including —
(i) the quantities in which the substance or
mixture is or will be manufactured,
(ii) the quantities in which the substance or
mixture enters or will enter the environment,
(iii) the number of individuals who are or will
be exposed to the substance or mixture in their places
of employment and the duration of such exposure,
(iv) the extent to which human beings are or
will be exposed to the substance or mixture,
(v) the extent to which the substance or mixture
is closely related to a chemical substance or mixture
which is known to present an unreasonable risk of
injury to health or the environment,
(vi) the existence of data concerning the effects
of the substance or mixture on health or the environment,
(vii) the extent to which testing of the substance
or mixture may result in the development of data upon
which the effects of the substance or mixture on health
or the environment can reasonably be determined or
predicted, and
(viii) the reasonably foreseeable availability of
facilities and personnel for performing testing on
the substance or mixture.
The recommendations of the committee shall be in the form of a list of
chemical substances and mixtures which shall be set forth, either by
individual substance or mixture or by groups of substances or mixtures,
in the order in which the committee determines the Administrator should
take action under subsection (a). The committee shall give priority
attention to those chemical substances and mixtures which are known to
cause or contribute to or which are suspected of causing or contributing
to cancer, gene mutations, or birth defects. The committee shall
designate chemical substances and mixtures on the list for which the
Administrator should, within 12 months initiate a proceeding under
subsection (a). The number of chemical substances and mixtures on the
list which are designated under the preceding sentence may not, at any
time, exceed 50.
-------
TSCA - 6
(B) As soon as practicable but not later than September 1,
1977, the committee shall publish the list in the Federal Register
together with the reasons for the committee's inclusion of each
chemical substance or mixture on the list. At least every six
months the committee shall revise the list and send it to the
Administrator together with the committee's reasons for the
revisions. Upon receipt of any such revision, the Administrator
shall publish in the Federal Register the list with such revision,
the reasons for the revision, and the designations made under
subparagraph (A). The Administrator shall provide reasonable
opportunity to any interested person to file written comments
on any new or revised list, and shall make such comments available
to the public. Within 12 months after its appearance on the
list, the Administrator shall, with respect to any chemical
substance or mixture, either initiate a rulemaking proceeding
under subsection (a) or publish in the Federal Register his
reason for not doing so.
(2) (A) The committee established by paragraph (1) (A)
shall consist of eight members as follows:
(i) One member appointed by the Administrator
from the Environmental Protection Agency..
(ii) One member appointed by the Secretary of
Labor from officers or employees of the Department of
Labor engaged in the Secretary's activities under the
Occupational Safety and Health Act of 1970.
(iii) One member appointed by the Chairman of
the Council on Environmental Quality from the Council
or its officers or employees.
(iv) One member appointed by the Director of the
National Institute for Occupational Safety and Health
from officers or employees of the Institute.
(v) One member appointed by the Director of the
National Institute of Environmental Health Sciences
from officers or employees of the Institute.
(vi) One member appointed by the Director of the
National Cancer Institute from officers or employees
of the Institute.
(vii) One member appointed by the Director of the
National Science Foundation from officers or employees
of the Foundation.
(viii) One member appointed by the Secretary of
Commerce frou officers or employees of the Department
of Commerce...
-------
TSCA - 7
(D) The Administrator shall provide the committee
such administrative support services as may be necessary
to enable the committee to carry out its function under
this subsection.
(f) REQUIRED ACTIONS. — Upon the receipt of —
(1) any test data required to be submitted under this Act, or
(2) which indicates that a chemical substance or mixture may
present or will present a significant risk of serious or
widespread harm to human beings from cancer, gene mutations,
or birth defects, the Administrator shall, within 180 days,
initiate appropriate action under section 5, 6, or 7 to
prevent or reduce such risk or publish in the Federal Register
a finding that such risk is not unreasonable. The Administrator
may extend such period for an additional period of not more
than 90 days. A finding by the Administrator that a risk is
not unreasonable shall be considered agency action for purposes
of judicial review. This subsection shall not take effect until
January 1, 1979.
x (g) PETITION FOR STANDARDS FOR THE DEVELOPMENT OF TEST DATA. —
A person intending to manufacture or process a chemical substance for
jj which notice is required under section 5(a) and who is not required
under a rule under subsection 4(a) above to conduct tests and submit
data on such substance may petition the Administrator to prescribe
standards for the development of test data for such substance. The
Administrator shall by order either grant or deny any such petition
within 60 days of its receipt. If the petition is granted, the Admin-
istrator shall prescribe such standards for such substance.
MANUFACTURING AND PROCESSING NOTICES
I
XI SEC. 5.
(a) IN GENERAL. —
(1) Except as provided in subsection (h) [exemptions],
no person may —
(A) manufacture a new chemical substance on or after
the 30th day after the publication of the inventory required
by section 8(b), or
(B) manufacture or process any chemical substance for
a use which the Administrator has determined, in accordance
with paragraph (2) below, is a significant new use,
unless such person submits to the Administrator, at least 90 days
before such manufacture or processing, a notice, in accordance
with subsection (d) below, of such person's intention to
-------
TSCA - 8
I manufacture or process such substance and such person submits
test data in compliance with any applicable requirement of
subsection (b) below.
II (2) A determination by the Administrator that a use of a
a chemical substance is a significant new use shall be made
by a rule promulgated after a consideration of all relevant
factors, including —
(A) the projected volume of manufacturing and
processing of a chemical substance,
(B) the extent to which a use changes the type
or form of exposure of human beings or the environment
to a chemical substance,
(C) the extent to which a use increases the magnitude
and duration of exposure of human beings or the environment
to a chemical substance, and
(D) the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and
disposal of a chemical substance.
(b) SUBMISSION OF TEST DATA. —
(1) (A) If a person is required by subsection (a)(1)
above to submit a premanufacture notice to the Administrator
and is also required to submit test data (pursuant to a rule
under section 4) before the submission of notice, he shall
submit the test data at the time notice is submitted...
XII (2) (A) If a person —
(i) is required to submit a notice before
beginning manufacture or processing of a chemical
substance listed by the Administrator on the list
described in paragraph (4) below, and
(ii) is not required by a rule promulgated
under section 4 to submit test data for such substance,
then such person shall submit data prescribed by subparagraph
(B) below at the time notice is submitted.
(B) Data submitted pursuant to subparagraph (A) above
shall be data which the person believes show that —
(i) the manufacture, processing, distribution
in commerce, use, and disposal of the chemical substance
or any combination of such activities will not present
an unreasonable risk of injury to health or the
environment, or
-------
TSCA - 9
(ii) the intended significant new use chemical
substance will not present an unreasonable risk of
injury to health or the environment.
XIV (3) Data submitted under paragraph (b)(1) or (b)(2)
above shall be made available, subject to section 14, for
examination by interested persons.
II (4) (A) (i) The Administrator may, by rule, compile
and keep current a list of chemical substances with
respect to which he finds that the manufacture,
processing, distribution in commerce, use, or disposal,
or any combination of such activities, presents or may
present an unreasonable risk of injury to health or
the environment.
(ii) In adding a substance to the list, the
Administrator shall consider all relevant factors,
including —
(I) the effects of the chemical substance
on health and the magnitude of human exposure
to such substance; and
(II) the effects of the chemical substance
on the environment and the magnitude of environmental
exposure to such substance.
(B) The Administrator shall, in prescribing a rule
which lists any chemical substance, identify those uses,
if any, which the Administrator determines, by rule under
subsection (a)(2), would constitute a significant new use
of such substance.
(C)... (iii) the Administrator shall make and publish
with any rule under this subsection, the finding required
in subparagraph (A)...
(d) CONTENT OF NOTICE; PUBLICATIONS IN THE FEDERAL REGISTER ~
XII
(1) The notice required by subsection (a) shall include —
(A) insofar as known to the person submitting the
notice or insofar as reasonably ascertainable, the infor-
mation described in subparagraphs (A), (B), (C), (D), (F) ,
and (6) of section 8(a)(2), and
(B) in such form and manner as the Administrator
may prescribe, any test data in the possession or control
of the person giving such notice which are related to the
-------
TSCA - 10
effect of any manufacture, processing, distribution in
commerce, use, or disposal of such substance or any
article containing such substance, or of any combination
of such activities, on health or the environment, and
V (C) a description of any other data concerning
the environmental and health effects of such substance
insofar as known to the person making the notice or
insofar as reasonably ascertainable.
Xiv Such a notice shall be made available, subject to section 14,
for examination by interested persons.
(2) Subject to section 14, not later than five [business]
XIV days after the date of the receipt of a notice or of data the
Administrator shall publish in the Federal Register a notice
which —
(A) identifies the chemical substance for which
notice or data has been received;
(B) lists the uses or intended uses of such substance;
and
(C) in the case of the receipt of data describes the
nature of the tests performed on such substance and any data
developed.
A notice under this paragraph respecting a chemical substance
shall identify the chemical substance by generic class unless
the Administrator determines that more specific identification
is required in the public interest.
(3) At the beginning of each month the Administrator shall
publish in the Federal Register a list of (A) each chemical
substance for which notice has been received under subsection
(a) and for which the notification period has not expired, and
(B) each chemical substance for which such notification period
has expired since the last publication in the Federal Register
of such list.
XVII (e) REGULATION PENDING DEVELOPMENT OF INFORMATION. —
(1) (A) If the Administrator determines that -
(i) the information available to the Administrator
is insufficient to permit a reasoned evaluation of the
health and environmental effects of a chemical substance
with respect to which notice is required by subsection
(a); and
-------
TSCA - 11
(ii) (I) in the absence of sufficient infor-
mation to permit the Administrator to make such
an evaluation, the manufacture, processing,
distribution in commerce, use, or disposal of
such substance, or any combination of such
activities, may present an unreasonable risk of
injury to health or the environment, or
(II) such substance is or will be produced
in substantial quantities, and such substance
either enters or may reasonably be anticipated
to enter the environment in substantial quantities
or there is or may be significant or substantial
human exposure to the substance, the Administrator
may issue a proposed order to take effect on the
expiration of the notification period, [or seek
a court injunction] to prohibit or limit the
manufacture, processing, distribution in commerce,
use, or disposal of such substance or to prohibit
or limit any combination of such activities,
pending development of further information...
XIV (g) STATEMENT OF REASONS FOR NOT TAKING ACTION. — If the
Administrator has not initiated any action to prohibit or limit the
manufacture, processing, distribution in commerce, use, or disposal of a
chemical substance, for which notification or data is required before
the expiration of the notification period he shall publish a statement
of his reasons for not initiating such action. The statement shall be
published in the Federal Register before the expiration of such period.
Publication in accordance with the preceding sentence is not a pre-
requisite to the manufacturing or processing of the substance with
respect to which the statement is to be published.
X (h) EXEMPTIONS. --
(1) The Administrator may, upon application, exempt any
person from any requirement of subsection (a) [premanufacture
notice] or (b) [submission of data] to permit such person to
manufacture or process a chemical substance for test marketing
purposes —
(A) upon a showing by such person that the manufacture,
processing, distribution in commerce, use, and disposal of
such substance, and any combination of such activities, for
such purposes will not present any unreasonable risk of
injury to health or the environment, and
(B) under such restrictions as the Administrator
considers appropriate.
-------
TSCA - 12
(2) (A) The Administrator may, upon application, exempt any
person from the requirement of subsection (b)(2) to submit
data for a chemical substance. If, upon receipt of an
application under the preceding sentence, the Administrator
determines that —
(i) the chemical substance with respect to which
such application was submitted is equivalent to a
chemical substance for which data has been submitted
to the Administrator as required by subsection 5(b)(2),
and
(ii) submission of data by the applicant would be
duplicative of data which has been submitted to the
Administrator in accordance with such subsection,
the Administrator shall exempt the applicant from the
requirement to submit data on the substance—
REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES
AND MIXTURES
XVII SEC. 6.
(a) SCOPE OF REGULATION. — If the Administrator finds that
there is a reasonable basis to conclude that the manufacture, processing,
distribution in commerce, use, or disposal of a chemical substance or
mixture, or that any combination of such activities, presents or will
present an unreasonable risk of injury to health or the environment, the
Administrator shall by rule apply one or more of the following require-
ments to such substance or mixture to the extent necessary to protect
adequately against such risk using the least burdensome requirements:
• • •
XV (3) A requirement that such substance or mixture or any
article containing such substance or mixture be marked with or
accompanied by clear and adequate warnings and instructions with
respect to its use, distribution in commerce, or disposal or
with respect to any combination of such activities. The form and
content of such warnings and instructions shall be prescribed
by the Administrator.
(4) A requirement that manufacturers and processors of such
substance or mixture make and retain records of the processes used
to manufacture or process such substance or mixture and monitor or
conduct tests which are reasonable and necessary to assure
compliance with the requirements of any rule applicable under this
subsection...
XI (7) A requirement directing manufacturers or processors
of such substance or mixture (A) to give notice of such unreason-
able risk of injury to distributors of such substance or mixture
and, to the extent reasonably ascertainable, to other persons
-------
TSCA - 13
in possession of or exposed to such substance or mixture, (B) to
give public notice of such risk of injury, and (C) to replace or
repurchase such substance or mixture (as elected by the person to
which the requirement is directed).
Any requirement (or combination of requirements) imposed under this
subsection may be limited in application to specified geographic areas.
(b) QUALITY CONTROL. — If the Administrator has a reasonable
basis to conclude that a particular manufacturer or processor is manu-
facturing or processing a chemical substance or mixture in a manner
which unintentionally causes or will cause the chemical substance or
mixture to present an unreasonable risk of injury to health or the
environment --
(1) the Administrator may by order 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 or mixture; and
(2) if the Administrator determines —
(A) that such quality control procedures are inadequate
the Administrator may order revision of the quality control
procedures to the extent necessary to remedy such inadequacy;
or
(B) that such quality control procedures have resulted
in distribution of chemical substances or mixtures which
present an unreasonable risk of injury to health or the
environment, the Administrator may order the manufacturer
XI or processor to (i) give notice of such risk to processors
or distributors or both, and, to the extent reasonably
ascertainable, to any other person in possession of or
exposed to the substance, (ii) to give public notice of
such risk, and (iii) to provide such replacement or repurchase
of any such substance or mixture as is necessary to adequately
protect health or the environment...
II (c) PROMULGATION OF SUBSECTION (a) RULES. —
(1) In promulgating any rule under subsection 6(a)> the
Administrator shall consider and publish a statement with respect
to —
(A) the effects of the substance or mixture on
health and the magnitude of human exposure,
(B) the effects of the substance or mixture on the
environment and the magnitude of environmental exposure,
-------
TSCA - 14
(C) the benefits of the substance or mixture for
various uses and the availability of substitutes for such
uses, and
(D) the reasonably ascertainable economic consequences
of the rule, after consideration of the effect on the
national economy, small business, technological innovation,
the environment, and public health.
IU If the Administrator determines that a risk of injury to health
or the environment could be eliminated or reduced to a sufficient
extent by actions taken under another Federal law (or laws)
administered in whole or in part by the Administrator, the Admin-
istrator may not promulgate a rule under subsection 6(a) unless he
finds that it is in the public interest. In making such a finding
the Administrator shall consider (i) all relevant aspects of the
risk, (ii) a comparison of the estimated costs of complying with
actions taken under this Act and under such law (or laws), and
(iii) the relative efficiency of actions under this Act and under
such law (or laws) to protect against such risk of injury...
IMMINENT HAZARDS
YT ov • / • • •
(b) RELIEF AUTHORIZED...
(2) In the case of an action under subsection (a) brought
against a person who manufactures, processes, or distributes
in commerce a chemical substance or mixture or an article
containing a chemical substance or mixture, the relief authorized
by paragraph (1) may include the issuance of a mandatory order
requiring (A) in the case of purchasers of such substance,
mixture, or article known to the defendant, notification to
such purchasers of the risk associated with it; (B) public
notice of such risk; (C) recall; (D) the replacement or
repurchase of such substance, mixture, or article; or (E) any
combination of the actions described in the preceding clauses...
REPORTING AND RETENTION OF INFORMATION
SEC. 8.
(a) Reports. —
(1) The Administrator shall promulgate rules under
which —
-------
TSCA - 15
(A) each person (other than a small manufacturer
or processor) who manufactures or processes or proposes to
manufacture or process a chemical substance (other than for
research) shall maintain such records, and shall submit
to the Administrator such reports, as he may reasonably
require, and
(B) each person (other than a small manufacturer
or processor) who manufactures or processes or proposes
to manufacture or process —
(i) a mixture, or
(ii) a chemical substance in small quantities
(as defined by the Administrator by rule) solely for
purposes of scientific experimentation or research,
including research or analysis for the development
of a product,
shall maintain records and submit to the Administrator
reports but only to the extent the Administrator determines
the maintenance of records or submission of reports, or
both, is necessary for the effective enforcement of this
Act.
The Administrator may not require in a rule promulgated under
this paragraph the maintenance of records or the submission of
reports with respect to changes in the proportions of the compon-
ents of a mixture unless the Administrator finds that the main-
tenance of such records or the submission of such reports, or both,
is necessary for the effective enforcement of this Act. For
purposes of the compilation of the inventory required under
subsection 8(b) below, the Administrator shall promulgate rules
pursuant to this subsection not later than June 30, 1977.
VI (2) The Administrator may require under paragraph (1)
XII above maintenance of records and reporting with respect to the
following, insofar as known to the person making the report or
insofar as reasonably ascertainable:
(A) The common or trade name, the chemical identity,
and the molecular structure of each chemical substance or
mixture for which such a report is required.
(B) The categories or proposed categories of use of each
such substance or mixture.
(C) The total amount of each such substance
and mixture manufactured or processed, or reasonable estimates
of the total amount to be manufactured or processed, the
amount manufactured or processed for each of its categories
-------
TSCA - 16
of use, and reasonable estimates of the amount to be manu-
factured or processed for each of its categories of use or
proposed categories of use.
(D) A description of the byproducts resulting from the
manufacture, processing, use, or disposal of each such
substance or mixture.
(E) All existing data concerning the environmental
and health effects of such substance or mixture.
(F) The number of individuals exposed, and reasonable
estimates of the number who will be exposed, to such substance
or mixture in their places of employment, and the duration of
such exposure.
(G) In the initial report under paragraph (1) on such
substance or mixture, the manner or method of its disposal,
and in any subsequent report on such substance or mixture, any
change in such manner or method.
XVII To the extent feasible, the Administrator shall not require under
paragraph (1) any reporting which is unnecessary or duplicative.
(3) (A) (i) The Administrator may by rule require a
small manufacturer or processor of a chemical substance
to submit to the Administrator such information
respecting the chemical substance as may be required for
publication of the first inventory required by subsection
(b) below.
(ii) The Administrator may by rule require
a small manufacturer or processor of a chemical
substance or mixture —
(I) subject to a rule proposed or promulgated
under section 4 [testing], 5(b)(4) [list of
possible hazards], or 6 [regulation of hazardous
substances or mixtures], or an order in effect
under section 5(e) [regulation pending develop-
ment of information] , or
(II) with respect to which relief has been
granted pursuant to a civil action brought under
section 5 or 7 [imminent hazards],
to maintain such records and to submit such reports as
he may reasonably require. A rule under this clause
requiring reporting may require reporting with respect
to the matters referred to in paragraph (2) above.
-------
TSCA - 17
(B) The Administrator, after consultation with the
Administrator of the Small Business Administration, shall
by rule prescribe standards for determining the manu-
facturers and processors which qualify as small manu-
facturers and processors for purposes of this paragraph and
paragraph (1).
H (b) INVENTORY. --
(1) The Administrator shall compile, keep current, and
publish a list [inventory] of each chemical which is manufactured
or processed in the United States. Such list shall at least
include each chemical substance which any person reports (under
section 5 or subsection (a) of this section) is manufactured or
processed in the United States. Such list may not include
any chemical substance which was not manufactured or processed
in the United States [after January 1, 1975]. A chemical
substance for which a premanufacture notice is submitted shall be
included on the inventory as of the earliest date on which such
substance was manufactured or processed. The Administrator shall
first publish such a list [inventory] not later than [November 11,
1977]. The Administrator shall not include any chemical substance
manufactured or processed only in small quantities (as defined by
the Administrator by rule) solely for purposes of scientific
experimentation or analysis or chemical research.
(2) To the extent consistent with the purposes of this Act,
the Administrator may, in lieu of listing a chemical substance
individually, list a category of chemical substances in which the
substance is included.
yj (c) RECORDS. — Any person who manufactures, processes, or
distributes in commerce any chemical substance or mixture shall maintain
records of significant adverse reactions to health or the environment,
as determined by the Administrator by rule, alleged to have been caused
by the substance or mixture. Records of such adverse reactions to the
health of employees shall be retained for a period of 30 years from the
date such reactions were first reported to or known by the person
maintaining such records. Any other record of such adverse reactions
shall be retained for a period of five years. Records required to be
maintained under this subsection shall include records of consumer
allegations of personal injury or harm to health, reports of occupational
disease or injury, and reports or complaints of injury to the environ-
VIII ment submitted to the manufacturer, processor, or distributor in commerce
XIII from any source. Upon request of any duly designated representative of
the Administrator, each person who is required to maintain records under
this subsection shall permit the inspection of such records and shall
submit copies of such records.
-------
TSCA - 18
XII (d) HEALTH AND SAFETY STUDIES. — The Administrator shall
promulgate rules under which he shall require any person who manu-
factures, processes, or distributes in commerce any chemical substance
or mixture (or with respect to paragraph (2) below, any person who has
possession of a study) to submit to the Administrator —
(1) lists of health and safety studies with respect to
such substance or mixture (A) conducted or initiated by or for such
person at any time, (B) known to such person, or (C) reasonably
ascertainable by such person, except that the Administrator may
exclude certain types or categories of studies from the require-
ments of this subsection if he finds that submission of lists of
such studies is unnecessary to carry out the purposes of this Act,
and
(2) copies of any study contained on a list submitted
pursuant to paragraph (1) above, or otherwise known by such person.
XI (e) NOTICE TO ADMINISTRATOR OF SUBSTANTIAL RISKS. — Any person
who manufactures, processes, or distributes in commerce a chemical
substance or mixture and who obtains information which reasonably
supports the conclusion that such substance or mixture presents a
substantial risk of injury to health or 'the environment shall immediately
inform the Administrator of such information unless such person has
actual knowledge that the Administrator has been adequately informed.
RELATIONSHIP TO OTHER FEDERAL LAWS
SEC. 9.
(a) LAWS NOT ADMINISTERED BY THE ADMINISTRATOR. —
(1) If the Administrator concludes that any activity or
combination of activities will present an unreasonable risk of
injury to health or the environment and that the risk may be
prevented or reduced sufficiently by another agency, he shall
submit to that agency a. report which describes the activity he
believes presents a risk. The report shall also request the
agency —
(A) (i) to determine if the risk may be prevented
or reduced sufficiently by the agency, and
(ii) if the agency determines that such risk may
be prevented or reduced, to issue an order declaring
whether or not the activity or combination of activities
indeed presents such risk; and
(B) to respond to the Administrator with respect to
the matters described in subparagraph (A).
-------
TSCA - 19
II Any report of the Administrator shall include a detailed
statement of the information on which it is based and be published
in the Federal Register. The agency receiving a request shall make
the requested determination, issue the requested order, and make
the requested response within such time as the Administrator
specifies but not in less than 90 days. The response of an agency
shall be accompanied by a detailed statement of the findings and
conclusions shall be published in the Federal Register...
II (3) If the Administrator initiates action under section 6 or
7 against a chemical substance or mixture which was the subject of
a report made to an agency under paragraph (1), such agency shall,
before taking any action of its own, consult with the Administrator
for the purpose of avoiding duplication of Federal action.
(b) LAWS ADMINISTERED BY THE ADMINISTRATOR. — The Administrator
shall coordinate his actions under this Act with his actions under other
Federal laws. If he determines that a risk to health or the environment
would be eliminated or reduced sufficiently by actions under other
Federal laws, the Administrator shall use such authorities unless he
determines it is in the public interest to protect against such risk by
actions under this Act...
(d) COORDINATION. — In administering this Act, the Administrator
shall consult and coordinate with the Secretary of Health, Education,
and Welfare and any other appropriate instrumentality of the Federal
Government for the purpose of achieving the maximum enforcement of this
Act while imposing the least burdens of duplicative requirements...
RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION,
AND UTILIZATION OF DATA
II SEC. 10.
Ill
(a) AUTHORITY. — The Administrator shall, in consultation and
cooperation with the Secretary of Health, Education, and Welfare and
with other appropriate departments and agencies, conduct such research,
^ development, and monitoring as is necessary to carry out the purposes
of this Act. The Administrator may enter into contracts and may make
grants for research, development, and monitoring under this subsection...
(b) DATA SYSTEMS. —
HI (!) The Administrator shall establish, administer, and
be responsible for the continuing activities of an interagency
committee which shall design, establish, and coordinate an efficient
and effective system, within the Environmental Protection Agency,
for the collection, dissemination to other Federal departments
and agencies, and use of data submitted under this Act.
-------
TSCA - 20
(2) (A) The Administrator shall, in consultation and
cooperation with the Secretary of Health, Education,
and Welfare and other appropriate departments and
agencies, design, establish, and coordinate an efficient
and effective system for the retrieval of toxicological
and other scientific data which could be useful to the
Administrator in carrying out the purposes of this
Act. Systematized retrieval shall be developed for
use by all Federal and other departments and agencies
with responsibilities in the area of regulation or
study of chemical substances and mixtures and their effect
on health or the environment...
(c) SCREENING TECHNIQUES. — The Administrator shall, with the
Assistant Secretary for Health of the Department of Health, Education,
and Welfare, undertake research directed toward the development of
rapid, reliable, and economical screening techniques for carcinogenic,
mutagenic, teratogenic, and ecological effects of chemical substances
and mixtures.
(d) MONITORING. — The Administrator shall, in consultation
and cooperation with the Secretary of Health, Education, and Welfare,
establish and be responsible for research aimed at the development of
monitoring techniques and instruments which may be used in the detection
of toxic chemical substances and mixtures and which are reliable,
economical, and capable of being implemented under a wide variety of
conditions .
(e) BASIC RESEARCH. — The Administrator shall, in consultation
and cooperation with the Secretary of Health, Education, and Welfare,
establish research programs to develop the fundamental scientific basis
of the screening and monitoring techniques described in subsections (c)
and (d) above, the bounds of the reliability of such techniques, and the
opportunities for their improvement. . .
(g) EXCHANGE OF RESEARCH AND DEVELOPMENT RESULTS. — The
Administrator shall, in consultation with the Secretary of Health,
Education, and Welfare and other appropriate departments and agencies,
establish and coordinate a system for exchange among Federal, State, and
local authorities of research and development results respecting toxic
chemical substances and mixtures, including a system to facilitate and
promote the development of standard data format and analysis and
consistent testing procedures.
INSPECTIONS AND SUBPOENAS
SEC. 11.
VIII (a) IN GENERAL. — For purposes of administering this Act, the
Administrr tor, and any duly designated representative of the
-------
TSCA - 21
Administrator, may inspect any establishment, facility, or other
premises in which chemical substances or mixtures are manufactured,
processed, stored, or held before or after their distribution in
commerce and any conveyance being used to transport chemical substances,
mixtures, or such articles in connection with distribution in commerce.
Such an inspection may^ only be made upon the presentation of appropriate
credentials and of a written notice. Each inspection shall be commenced
and completed with reasonable promptness and shall be conducted at
reasonable times, within reasonable limits, and in a reasonable manner.
(b) SCOPE. —
(1) Except as provided in paragraph (2), an inspection conducted
under subsection (a) shall extend to all things within the premises
or conveyance inspected (including records, files, papers,
processes, controls, and facilities) bearing on whether the require-
ments of this Act applicable to the chemical substances or mixtures
within such premises or conveyance have been complied with.
(2) No inspection under subsection (a) shall extend
to —
(A) financial data,
(B) sales data (other than shipment data),
(C) pricing data,
(D) personnel data, or
(E) research data (other than data required by this
Act or under a rule promulgated thereunder),
unless the nature and extent of such data are described with
reasonable specificity in the written notice required by sub-
section (a) for such inspection.
IX (c) SUBPOENAS. — In carrying out this Act, the Administrator
may by subpoena require the attendance and testimony of witnesses
and the production of reports, papers, documents, answers to questions,
and other information that the Administrator deems necessary...
EXPORTS
XVII SEC. 12.
(a) IN GENERAL. —
(1) Except as provided in paragraph (2) and subsection (b)
below, this Act (other than section 8) shall not apply to
any chemical substance, mixture, or to an article containing
a chemical substance or mixture, if —
-------
TSCA - 22
(A) it can be shown that such substance, mixture,
or article is being manufactured, processed, or distributed
in commerce for export from the United States, unless such
substance, mixture, or article was, in fact, manufactured,
processed, or distributed in commerce, for use in the United
States, and
(B) such substance, mixture, or article (when distributed
in commerce), or any container in which it is enclosed,
bears a stamp or label stating that such substance, mixture,
or article is intended for export.
(2) Paragraph (1) shall not apply to any chemical substance,
mixture, or article if the Administrator finds that it will present
an unreasonable risk of injury to health or the environment in
the United States. The Administrator may require, under section 4,
testing of any chemical substance or mixture exempted from this Act
by paragraph (1) for the purpose of determining whether or not such
substance or mixture presents an unreasonable risk of injury to
health or the environment in the United States.
XI (b) NOTICE. —
(1) If any person exports or intends to export a chemical
substance or mixture for which the submission of data is required
under section 4 [testing] or 5(b) [list of possible hazards], such
person shall notify the Administrator of such exportation or
intent and the Administrator shall furnish to the government of
such country notice of the availability of the data submitted.
(2) If any person exports or intends to export a chemical
substance or mixture for which an order has been issued under
section 5 or a rule has been proposed or promulgated under section
5 [premanufacture notices] or 6 [regulation of hazardous sub-
stances] or with respect to which an action is pending, or relief
has been granted under section 5 [regulation pending development
of information and protection against unreasonable risk]
or 7 [imminent hazards], such person shall notify the Administrator
of such exportation or intent to export and the Administrator
shall furnish to the government of such country notice of such
rule, order, action, or relief.
ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES
XVII SEC. 13.
(a) IN GENERAL. —
-------
TSCA - 23
(1) The Secretary of the Treasury shall refuse entry
into the customs territory of the United States of any chemical
substance, mixture, or article containing a chemical substance
or mixture offered for such entry if —
(A) it fails to comply with any rule in effect under
this Act, or
(B) it is offered for entry in violation of section
5 or 6, a rule or order under section 5 or 6, or an order
issued in a civil action brought under section 5 or 7...
DISCLOSURE OF DATA
XIV SEC. 14.
(a) IN GENERAL. — Except as provided by subsection (b) below,
any information otherwise obtained by the Administrator which is
exempt from disclosure pursuant to subsection (a) of section 552
of title 5, United States Code, by reason of subsection (b)(4) of
such section shall not be disclosed except that such information —
(1) shall be disclosed to any officer or employee of
the United States —
(A) in connection with the official duties of such
employee under any law for the protection of health or
the environment, or
(B) for specific law enforcement purposes;
(2) shall be disclosed to contractors with the United States
and employees of such contractors if such disclosure is necessary
and under such conditions as the Administrator may specify;
(3) shall be disclosed if the Administrator determines it
necessary to protect health or the environment; or
(4) may be disclosed when relevant in any proceeding under
this Act, except that disclosure shall be made in such manner as
to preserve confidentiality.
In any proceeding under section 552(a) of title 5, United States Code,
to obtain information the disclosure of which has been denied because
of the provisions of this subsection, the Administrator may not rely
on section 552(b)(3) of such title to sustain the Administrator's action.
(b) DATA FROM HEALTH AND SAFETY STUDIES. —
(1) Subsection (a) does not prohibit the disclosure of —
(A) any health and safety study which is submitted
under this Act with respect to —
-------
TSCA - 24
(i) any chemical substance or mixture which
has been offered for commercial distribution, or
(ii) any chemical substance or mixture for which
testing is required under section 4 or for which
notification is required under section 5, and
(B) any data obtained by the Administrator from
a health and safety study which relates to such a chemical
substance or mixture.
This paragraph does not authorize the release of any data which
discloses processes used in the manufacturing or processing of a
chemical substance or mixture or, in the case of a mixture, the
release of data disclosing the portion of the mixture comprised by
any of the chemical substances in the mixture.
(2) If a request is made to the Administrator under subsection
(a) of section 552 of title 5, United States Code, for health and
safety study information described above (which is not process or
formulation information as described above) the Administrator may
i.ot deny such request on the basis of subsection (b) (4) of section
552 of title 5, U.S.C.
(c) DESIGNATION AND RELEASE OF CONFIDENTIAL DATA. —
(1) In submitting data under this Act, a manufacturer,
processor, or distributor in commerce may designate the data which
he believes is entitled to confidential treatment under subsection
(a), and submit such data separately from other data. A designation
under this paragraph shall be made in writing in such manner as
the Administrator prescribes.
(2) (A) Except as provided by subparagraph (B) below, if the
Administrator proposed to release for inspection data which
has been designated confidential, he shall notify, by certified
mail, the manufacturer, processor, or distributor in commerce
who submitted such data of his intent to release it. If the
release is to be made pursuant to a request under section 552(a)
of title 5, United States Code, the required notice shall be
given immediately upon approval of such request. The
Administrator may not release such data until the expiration
of 30 days after the manufacturer, processor, or distributor
in commerce has received the required notice.
(B) (i) Subparagraph (A) above, requiring notices
prior to release of information, shall not apply to the
release of information under paragraph (1), (2), (3),
or (4) of subsection (a) above, except that the
-------
TSCA - 25
Administrator may not release data under paragraph (3) of
subsection (a) unless he has notified each manufacturer,
processor, and distributor in commerce who submitted the
data of the release. Such notice shall be made by
certified mail at least 15 days before the release. If
the Administrator determines that the release of data is
necessary to protect against an imminent, unreasonable
risk, of injury to health or the environment, such notice
may be made by such means as he determines will provide
notice at least 24 hours before such release is made.
(ii) Subparagraph (A) shall not apply to the release
of information in health and safety studies as described
in subsection (b)(1) other than process and formulation
information described in the second sentence of that
subsection...
STUDIES
II SEC. 25.
(b) CLASSIFICATION, STORAGE, AND RETRIEVAL STUDY. — The Council
on Environmental Quality, in consultation with the Administrator, the
Secretary of Health, Education, and Welfare, the Secretary of Commerce,
and the heads of other appropriate Federal departments or agencies,
shall coordinate a study of the feasibility of establishing (1) a
standard classification system for chemical substances and related
substances, and (2) a standard means for storing and for obtaining rapid
access to information respecting such substances. A report on such
study shall be completed and submitted to Congress not later than [July
1, 1977].
ADMINISTRATION OF THE ACT
SEC. 26.
Ill (a) COOPERATION OF FEDERAL AGENCIES. — Upon request by the
Administrator, each Federal department and agency is authorized —
(1) to make its services, personnel, and facilities available
(with or without reimbursement) to the AdminJstrator to assist
the Administrator in the administration of this Act; and
(2) to furnish to the Administrator such information, data,
estimates, and statistics, and to allow the Administrator access
to all information in its possession as the Administrator may
reasonably determine to be necessary for the administration of
this Act...
-------
TSCA - 26
(c) ACTION WITH RESPECT TO CATEGORIES. ~
(1) Any action authorized or required to be taken by the
Administrator under any provisions of this Act with respect to a.
chemical substance or mixture may be taken by the Administrator in
accordance with that provision with respect to a category of
chemical substances or mixtures. Whenever the Administrator takes
action under a provision of this Act with respect to a category of
chemical substances or mixtures, any reference in this Act to a
chemical substance or mixture (insofar as it relates to such
action) shall be deemed to be a reference to each chemical substance
or mixture in such category.
(2) For purposes of paragraph (1):
(A) The term "category of chemical substances" means a
group of chemical substances the members of which are similar
in molecular structure, in physical, chemical, or biological
properties, in use, or in mode of entrance into the human body
or into the environment, or the members of which are in some
other way suitable for classification as such for purposes of
this Act, except that such term does not mean a group of
chemical substances which are grouped together solely on the
basis of their being new chemical substances.
(B) The term "category of mixtures" means a group of
mixtures the members of which are similar in molecular
structure, in physical, chemical, or biological properties, in
use, or in the mode of entrance into the human body or into
the environment, or the members of which are in some other way
suitable for classification as such for purposes of this
Act...
(f) STATEMENT OF BASIS AND PURPOSE. ~ Any final order issued
under this Act shall be accompanied by a statement of its basis and
purpose. The contents and adequacy of such statements shall not be
subject to judicial review in any respect...
DEVELOPMENT AND EVALUATION OF TEST METHODS
SEC. 27.
(a) IN GENERAL. — The Secretary of Health, Education and
Welfare, in consultation with the Administrator and acting through the
Assistant Secretary for Health, may conduct, and make grants to public
and nonprofit private entities and enter into contracts with public and
private entities for, projects for the development and evaluation of
-------
TSCA - 27
inexpensive and efficient methods (1) for determining and evaluating the
health and environmental effects of chemical substances and mixtures,
and their toxicity, persistence, and other characteristics which affect
health and the environment, and (2) which may be used for the development
of test data to meet the requirements of rules promulgated under section
4. The Administrator shall consider such methods in prescribing under
section 4 standards for the development of test data...
SEC. 30.
The Administrator shall submit to the President and Congress each
January 1, a report including —
(1) a list of the testing required under section 4 during
the year and an estimate of the costs imposed by such testing
requirement...
-------
PUBLIC LAW 94-580 — October 21, 1976
"RESOURCE CONSERVATION AND RECOVERY ACT OF 1976"
SUBTITLE A — GENERAL PROVISIONS
DEFINITIONS
SEC. 1004.
As used in this Act: ...
XVI (1) "Administrator" means the Administrator of the
Environmental Protection Agency...
XVI (3) "Disposal" means the discharge, deposit, injection,
dumping, spilling, leaking, or placing of any solid waste or
hazardous waste into or on any land or water so that such solid
waste or hazardous waste or any constituent thereof may enter the
environment or be emitted into the air or discharged into any
waters, including ground waters...
XVI (5) "Hazardous waste" means a solid waste, or
combination of solid wastes, which because of its quantity,
concentration, or physical, chemical, or infectious characteristics
may —
(A) cause, or significantly contribute to an increase in
mortality or an increase in serious irreversible, or incapac-
itating reversible illness, or;
(B) pose a substantial present or potential hazard to
human health or the environment when improperly treated,
stored, transported, or disposed of, or otherwise managed...
XVI (12) "Manifest" means the form used for identifying the
quantity, composition, and the origin, routing, and destination
of hazardous waste during its transportation from the point of
generation to the point of disposal, treatment, or storage...
(27) "Solid waste" means any garbage, refuse, sludge from
a waste treatment plant, water supply treatment plant, or air
pollution control facility and other discarded material, including
solid, liquid, semisolid, or contained gaseous material resulting
from industrial, commercial, mining, and agricultural operations,
-------
RCRA - 2
and from community activities, but does not include solid or
dissolved material in domestic sewage, or solid or dissolved
materials in irrigation return flows or industrial discharges which
are point sources subject to permits under section 402 of the
Federal Water Pollution Control Act, as amended (86 Stat. 880), or
source, special nuclear, or byproduct material as defined by the
Atomic Energy Act of 1954, as amended (68 Stat. 923)...
XVI (33) "Storage", when used in connection with hazardous
waste, means the containment of hazardous waste, either on a
temporary basis or for a period of years, in such a manner as not
to constitute disposal of such hazardous waste.
XVI (34) "Treatment", when used in connection with hazardous
waste, means any method, technique, or process, including
neutralization, designed to change the physical, chemical, or
biological character or composition of any hazardous waste so as to
neutralize such waste or so as to render such waste nonhazardous,
safe for transport, amenable for recovery, amenable for storage, or
reduced in volume. Such term includes any activity or processing
designed to change the physical form or chemical composition of
hazardous waste so as to render it nonhazardous...
APPLICATION OF ACT AND INTEGRATION WITH OTHER ACTS
SEC. 1006...
(b) INTEGRATION WITH OTHER ACTS. — The Administrator shall
integrate all provisions of this Act and shall avoid duplication, to the
maximum extent practicable, with the appropriate provisions of the Clean
Air Act, the Federal Water Pollution Control Act, the Federal Insecticide,
Fungicide, and Rodenticide Act, the Safe Drinking Water Act, the Marine
Protection, Research and Sanctuaries Act of 1972 and such other Acts of
Congress as grant regulatory authority to the Administrator. Such
integration shall be effected only to the extent that it can be done in
a manner consistent with the goals and policies expressed in this Act
and in the other acts.
SOLID WASTE MANAGEMENT INFORMATION AND GUIDELINES
SEC. 1008.
II (a) GUIDELINES. — By October 21, 1977, the Administrator shall,
in cooperation with appropriate Federal, State, municipal, and intermunicipal
-------
RCRA - 3
agencies, and in consultation with other interested persons, and after
public hearings, develop and publish suggested guidelines for solid
waste management. Such suggested guidelines shall —
(1) provide a technical and economic description of the
level of performance that can be attained by various available
solid waste management practices (including operating practices)
which provide for the protection of public health and the
environment;
(2) not later than October 21, 1978, describe levels of
performance, including appropriate methods and degrees of control,
that provide at a minimum for (A) protection of public health and
welfare; (B), protection of the quality of ground waters and surface
waters from leachates; (C) protection of the quality of surface
waters from runoff through compliance with effluent limitations
under the Federal Water Pollution Control Act, as amended; (D)
protection of ambient air quality through compliance with new
source performance standards or requirements of air quality
implementation plans under the Clean Air Act, as amended; (E)
disease and vector control; (F) safety; and (G) esthetics; and
(3) provide minimum criteria to be used-by the States to
define those solid waste management practices which constitute the
open dumping of solid waste or hazardous waste and are to be
prohibited under title IV of this Act.
Where appropriate, such suggested guidelines also shall include minimum
information for use in deciding the adequate location, design, and
construction of facilities associated with solid waste management
practices including the consideration of regional geographic, demo-
graphic and climatic factors.
SUBTITLE B — OFFICE OF SOLID WASTE; AUTHORITIES
OF THE ADMINISTRATOR
AUTHORITIES OF THE ADMINISTRATOR
SEC. 2002.
(a) AUTHORITIES. — In carrying out this Act, The Administrator
is authorized to —
VII (1) prescribe, in consultation with Federal, State, and
regional authorities, such regulations as are necessary to carry
out his functions under this Act; ...
-------
RCRA - 4
SUBTITLE C — HAZARDOUS WASTE MANAGEMENT
IDENTIFICATION AND LISTING OF HAZARDOUS WASTE
SEC. 3001.
II (a) CRITERIA FOR IDENTIFICATION OR LISTING. — Not later than
March 21, 1978, the Administrator shall, after notice and opportunity
for public hearing, and after consultation with appropriate Federal and
State agencies, develop and promulgate criteria for identifying the
characteristics of hazardous waste, and for listing hazardous waste,
which should be subject to the provisions of this subtitle, taking into
account toxicity, persistence, and degradability in nature, potential
for accumulation in tissue, and other related factors such as flammability,
corrosiveness, and other hazardous characteristics. Such criteria shall
be revised from time to time as may be appropriate.
II (b) IDENTIFICATION AND LISTING. — Not later than April 22, 1978,
the Administrator shall promulgate regulations identifying the char-
acteristics of hazardous waste, and listing particular hazardous
wastes...
STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE
II SEC. 3002.
Not later than April 22, 1978, the Administrator shall promulgate
regulations establishing standards applicable to generators of hazardous
waste. Such standards shall establish requirements respecting —
VI (1) record-keeping to accurately identify the quantities of
such hazardous waste generated, the significant constituents
thereof and the disposition of such wastes;
XV (2) labeling for containers used for storage, transport,
or disposal of hazardous waste that accurately identifies*such
waste;...
XI (4) furnishing information on the chemical composition to
persons transporting, treating, storing, or disposing of such
wastes;
VI (5) use of a manifest system to assure that all such hazardous
waste is designated for treatment, storage, or disposal in facilities
for which a permit has been issued; and
-------
RCRA - 5
XII (6) submission of reports to the Administrator (or the
State agency authorized to carry out the permit program) setting
out —
(A) the quantities of hazardous waste that he has
generated during a particular time period; and
(B) the disposition of that hazardous waste.
STANDARDS APPLICABLE TO TRANSPORTERS OF HAZARDOUS WASTE
SEC. 3003.
II (a) STANDARDS. — Not later than April 22, 1978, the Administrator,
III after consultation with the Secretary of Transportation shall promulgate
regulations establishing standards, applicable to transporters of
hazardous waste. Such standards shall include requirements respecting —
(1) record-keeping concerning such hazardous waste trans-
ported, and their source and delivery points;
XV (2) transportation of such waste only if properly labeled;
VI (3) compliance with the manifest system referred to in
section 3002(5); and
XVI (4) transportation of all such hazardous waste only to the
hazardous waste facilities which the shipper designates on the
manifest form to be a permit-holding facility.
(b) COORDINATION. — In all regulations under this Act, the
Administrator will consult and coordinate with the regulations and
activities of the Secretary of Transportation under the Hazardous
Materials Transporation Act.
STANDARDS APPLICABLE TO OWNERS AND OPERATORS
OF HAZARDOUS WASTE TREATMENT, STORAGE,
AND DISPOSAL FACILITIES
SEC. 3004.
Not later than April 22, 1978, the Administrator shall promulgate
regulations establishing performance standards applicable to owners
and operators of facilities for the treatment, storage, or disposal
of hazardous waste. Such standards shall include requirements
respecting —
-------
RCRA - 6
VI (1) maintaining records of all hazardous wastes treated,
stored, or disposed of and the manner in which this was done;
III V VI (2) satisfactory reporting, monitoring, and inspection
XH and compliance with the manifest system referred to in section
3002(5);...
X (7) compliance with the requirements of section 3005
respecting permits for treatment, storage, or disposal.
PERMITS FOR TREATMENT, STORAGE OR DISPOSAL
OF HAZARDOUS WASTE
X SEC. 3005.
(a) PERMIT REQUIREMENTS. — Not later than April 22, 1978, the
Administrator shall promulgate regulations requiring each person owning
or operating a facility for the treatment, storage, or disposal of
hazardous waste to have a permit issued pursuant to this section.
Ninety days after the Administrator has published the subsection 3001 (b)
list of hazardous wastes, the disposal of any such waste is prohibited
except in accordance with such a permit.
XII (b) REQUIREMENTS OF PERMIT APPLICATION. — Each application for a
permit shall contain such information as may be required under regulations
promulgated by the Administrator, including information respecting ----
(1) estimates of the composition, quantities, and con-
centrations of any hazardous waste proposed to be disposed of,
treated, transported, or stored, and the time, frequency, or
rate at which such waste is proposed to be disposed of, treated,
transported, or stored; and
(2) the site at which such hazardous waste will be disposed
of, treated, transported to, or stored.
INSPECTIONS
SEC. 3007.
(a) ACCESS ENTRY. — For purposes of developing any regulation or
enforcing the provisions of this subtitle, any person who generates,
stores, treats, transports, disposes of, or otherwise handles hazardous
-------
RCRA - 7
wastes shall, upon request of any officer designated by the Administrator,
XIII or any designated officer of a State having an authorized hazardous
waste program, furnish or permit such officer at all reasonable times to
have access to, and to copy all records relating to such wastes. Such
officers are authorized —
(1) to enter at reasonable times any establishment where
hazardous wastes are generated, stored, treated, or disposed of;
(2) to inspect and obtain samples of any such wastes and
samples of any containers or labeling for such wastes.
XIV (b) AVAILABILITY TO PUBLIC. — Any records, reports, or information
obtained from any person under this section shall be available to the
public, except that upon a showing that such records, reports, or
information, are entitled to protection under section 1905 of Title 18
of the United States Code, the Administrator shall consider such
information confidential in accordance with the purposes of that
section, except that such record, report, document, or information may
be disclosed to other officers, of the United States concerned with
carrying out this Act, or when relevant in any proceeding under this
Act.
ENFORCEMENT
XVII SEC. 3008.
(a) COMPLIANCE ORDERS. — Whenever, on the basis of any information,
the Administrator determines that any person is in violation of any
requirement of this subtitle, he shall give notice to the violator. If
such violation extends beyond the thirtieth day after notification, the
Administrator may issue an order requiring compliance within a specified
time period...
(3) If such violator fails to take corrective action
within the time specified in the order, the Administrator may
suspend or revoke any permit issued to the violator.
IV (b) PUBLIC HEARING. — Any order or any suspension or revocation
of a permit shall become final unless the person named therein requests
a public hearing. Upon such request the Administrator shall promptly
conduct a public hearing. In connection with and proceeding under this
IX section, the Administrator may issue subpoenas for the attendance and
testimony of witnesses and the production of relevant papers, books, and
documents, and may promulgate rules for discovery procedures.
-------
RCRA - 8
EFFECTIVE DATE
SEC. 3010.
X XI (a) PRELIMINARY NOTIFICATION. — Not later than ninety days after
promulgation of regulations under section 3001 identifying or listing
any substance as hazardous waste any person generating or transporting
such substance or owning or operating a facility for treatment, storage,
or disposal of such substance shall file with the Administrator a
notification stating the location and general description of such
activity and the identified or listed hazardous wastes handled. Not
more than one such notification shall be required with respect to the
same substance. No identified or listed hazardous waste may be
transported, treated, stored, or disposed of unless notification has
been given under this subsection...
SUBTITLE D — STATE OR REGIONAL SOLID WASTE PLANS
[Subtitle D contains requirements for the Administrator
to develop criteria to assist states in developing
solid waste management plans. However, this subtitle
is not, in general, applicable to developing or
disseminating information on toxic substances and
is, therefore, omitted.]
SUBTITLE F — FEDERAL RESPONSIBILITIES
COOPERATION WITH ENVIRONMENTAL PROTECTION AGENCY
III SEC. 6003.
All Federal agencies having functions relating to solid waste or
hazardous waste shall cooperate to the maximum extent permitted by law
with the Administrator in carrying out his functions under this Act and
shall make all appropriate information, facilities, personnel, and other
resources available, on a reimbursable basis, to the Administrator upon
his request.
-------
RCRA - 9
SUBTITLE H — RESEARCH, DEVELOPMENT, DEMONSTRATION,
AND INFORMATION
RESEARCH, DEMONSTRATION, TRAINING, AND
OTHER ACTIVITIES
II SEC. 8001.
HI (a) GENERAL AUTHORITY. — The Administrator, alone or after
consultation with the Administrator of the Federal Energy Administration,
the Administrator of the Energy Research and Development Administration,
or the Chariman of the Federal Power Commission, shall conduct, encourage,
coordinate, cooperate with, and render financial and other assistance to
appropriate public and private agencies and institutions, and individuals
in the conduct of research, investigations, experiments, training,
demonstrations, surveys, public education-programs, and studies relating
to —
(1) any adverse health and welfare effects of the release
into the environment of material present in solid waste, and
methods to eliminate such effects;...
(5) the reduction of the amount of such waste and
unsalvageable waste materials; ...
(10) improvements in land disposal practices for solid waste
(including sludge) which may reduce the adverse environmental
effects of such disposal and other aspects of solid waste disposal
on land, including means for reducing the harmful environmental
effects of earlier and existing landfills, means for rendering
landfills safe for purposes of construction and other uses, and
techniques of recovering materials and energy from landfills; ...
(12) methods of hazardous waste management, including methods
of rendering such waste environmentally safe; and
(13) any adverse effects on air quality (particularly with
regard to the emission of heavy metals) which result from solid
waste which is burned (either alone or in conjunction with other
substances) for purposes of disposal or energy recovery.
-------
RCRA - 10
III (b) MANAGEMENT PROGRAM. —
(1) (A) In carrying out his functions pursuant to this
Act, and any other Federal legislation respecting solid
waste or discarded material research, development, and demon-
strations, the Administrator shall establish a management
program or system to insure the coordination of all such
activities and to facilitate and accelerate the process of
development of sound new technology (or other discoveries)
from the research phase, through development, and into the
demonstration phase.
SPECIAL STUDIES; PLANS FOR RESEARCH, DEVELOPMENT,
AND DEMONSTRATIONS
II SEC. 8002...
(b) COMPOSITION OF WASTE STREAM. — The Administrator shall undertake
a systematic study of the composition of the solid waste stream and of
anticipated future changes in the composition of such stream and shall
publish a report containing the results of such study and quantitatively
evaluating the potential utility of such components...
Ill (f) MINING WASTE. — The Administrator, in consultation with the
Secretary of the Interior, shall conduct a detailed and comprehensive
study on the adverse effects on the environment, of solid waste from
mines including effects on humans, water, air, health, welfare, and
natural resources, and on means currently employed to dispose of and
utilize such solid wastes and to prevent or substantially mitigate such
adverse effects. Such study shall include an analysis of —
(1) the sources and volume of discarded material generated
per year from mining;
(2) present disposal practices;
(3) potential dangers to human health and the environment
from surface runoff of leachate and air pollution by dust;
(4) alternatives to current disposal methods;
(5) the cost of those alternatives in terms of the impact on
mine product costs; and
(6) potential for use of discarded material as a secondary
source of the mine product.
The Administrator shall publish a report and shall include findings and
recommendations.
-------
RCRA - 11
(g) SLUDGE. — The Administrator shall undertake a comprehensive
study on sludge. Such study shall include an analysis of —
(1) types of solid waste to be classified as sludge;
(2) effects of air and water pollution legislation on the
creation of sludge;
(3) amounts of sludge originating in each State and in each
industry producing sludge;
(4) methods of disposal, including cost, efficiency, and
effectiveness of such methods;
(5) alternative methods for the use of sludge, including
agricultural applications of sludge and energy recovery from
sludge; and
(6) methods to reclaim sludge disposal or sludge-damaged
areas.
(1) COMPLETION OF RESEARCH AND STUDIES. ^- The Administrator shall
complete the research and studies, and submit the reports, required
under subsections (b) , (c) , (d) , (e) , (f ) , (g) , and (k) not later than
October 1, 1978. He shall complete the research and studies, and submit
the reports, required under subsections (a), (h) , (i) , and (j) not later
than October 1, 1979. Upon completion of each study the Administrator
shall prepare a plan for research, development, and demonstration
respecting the findings of the study and shall submit any legislative
recommendations resulting from such study to Congress.
COORDINATION, COLLECTION, AND DISSEMINATION
OF INFORMATION
II SEC. 8003.
(a) INFORMATION. — The Administrator shall develop, collect,
evaluate, and coordinate information on — ...
(6) hazardous so^Lid waste, including incidents of damage
resulting from the disposal of hazardous solid wastes; inherently
and potentially hazardous solid wastes; methods of neutralizing
or properly disposing of hazardous solid wastes; facilities that
properly dispose of hazardous wastes ;. . .
(b) LIBRARY. —
(1) The Administrator shall establish a central reference
library for materals collected pursuant to subsection (a) above
. . . and other data and information with respect to — ...
-------
RCRA - 12
(ill) the various systems and technologies for
collection, transport, storage, treatment, and final
disposition of solid waste, and
(iv) other aspects of solid waste and hazardous
solid waste management.
Such central reference library shall also contain ... subject to
any confidentiality requirements, information respecting any aspect
of solid waste provided by employees of EPA which may be of value
to Federal, State, and local authorities and other persons.
(2) Information in the central reference library shall, to
the extent practicable, be collated, analyzed, verified, and
published and shall be made available to State and local govern-
ments and other persons at reasonable times and subject to such
reasonable charges as may be necessary to defray expenses of making
such information available.
XIV (e) INFORMATION PROGRAMS. —
(1) The Administrator shall implement a program for the rapid
dissemination of information on ... hazardous waste management ...
including the results of any relevant research, investigations,
experiments, surveys, studies or other information which may be
useful in the implementation of new or improved solid waste
management practices and methods and information on any other
technical, managerial, financial, or market aspect of resource
conservation and recovery facilities...
Ill (f) COORDINATION. — In collecting and disseminating information
under this section, the Administrator shall coordinate his actions and
cooperate to the maximum extent possible with State and local authorities.
-------
PUBLIC LAW 92-516 — October 21, 1972
"THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT"
SEC. 2. DEFINITIONS.
For purposes of this Act — ...
XVI (e) CERTIFIED APPLICATOR, ETC.
(1) Certified Applicator.— "Certified applicator" means
any individual who is certified to use or supervise the use
of any pesticide which is classified for restricted use.
XVI (2) Private Applicator.— "Private applicator" means a
certified applicator who uses or supervises the use of any
pesticide which is classified for restricted use for purposes
of producing any agricultural commodity on property owned or
rented by him or his employer or (if applied without compensation
other than trading of personal services between producers of
agricultural commodities) on the property of another person.
XVI (3) Commercial Applicator. — "Commercial applicator"
means a certified applicator (whether or not he is a private
applicator with respect to some uses) who uses or supervises
the use of any pesticide which is classified for restricted use
for any purpose or on any property other than as provided by
paragraph (2)...
XVI (n) INGREDIENT STATEMENT. — "Ingredient statement" means a
statement which contains —
(1) the name and percentage of each active ingredient,
and the total percentage of all inert ingredients, in the
pesticide; and
(2) if the pesticide contains arsenic, a statement of the
percentages of total and water soluble arsenic, calculated
as elementary arsenic...
(p) LABEL AND LABELING.—
(1) Label. — "Label" means the written, printed, or graphic
matter on, or attached to, the pesticide or device or any
of its containers or wrappers.
-------
FIFRA - 2
XVI (2) Labeling. — "Labeling" means all labels and all
other written, printed, or graphic matter —
(A) accompanying the pesticide or device at any
time; or
(B) to which reference is made on the label or in
literature accompanying the pesticide or device.
XVI (q) MISBRANDED.—
(1) A pesticide is misbranded if —
(A) its labeling bears any statement, design, or
graphic representation which is false or misleading;
(B) it is contained in a package which does not conform
to the standards established by the Administrator pursuant
to section 25(c)(3) [pesticide packaging];
(C) it is an imitation of, or is offered for sale under
the name of, another pesticide;
(D) its label does not bear the registration number
assigned under section 7 to each establishment in which it
was produced;
(E) any word, statement, or other information required
by or under authority of this Act to appear on the label
or labeling is not prominently placed thereon with such
conspicuousness and in such terms as to render it likely
to be read and understood by the ordinary individual under
customary conditions of purchase and use;
(F) the labeling accompanying it does not contain
directions for use which are necessary for effecting the
purpose for which the product is intended and if complied
with, together with any requirement imposed under section
3(d) of this Act, is adequate to protect health and the
environment;
(G) the label does not contain a warning or caution
statement which may be necessary and if complied with,
together with any requirements imposed under section 3(d)
of this Act, is adequate to protect health and the environ-
ment.
-------
FIFRA - 3
(2) A pesticide is misbranded If —
(A) the label does not bear an ingredient statement
on that part of the immediate container which is presented
or displ/ayed under customary conditions of purchase,
except that a pesticide is not misbranded under this
subpara/graph if:
(i) the size or form of the immediate container,
-makes it impracticable to place the ingredient statement
on the part which is presented or displayed under
customary conditions of purchase; and
(ii) the ingredient statement appears prominently
on another part of the immediate container permitted
by the Administrator;
(B) the labeling does not contain a statement of the
use classification under which the product is registered;
(C) there is not affixed to its container, a label
bearing —
(i) the name and address of the producer,
registrant, or person for whom produced;
(ii) the name, brand, or trademark under which
the pesticide is sold;
(iii) the net weight or measure of the content:
Provided, that the Administrator may permit reasonable
variations; and
(iv) when required by regulation of the Admin-
istrator to effectuate the purposes of this Act, the
registration number assigned to the pesticide under
this Act, and the use classification; and
(D) the pesticide contains any substances or substances
in quantities highly toxic to man, unless the label bears,
in addition to any other matter required by this Act —
(i) the skull and crossbones;
(ii) the word '"poison" prominently in red
on a background of distinctly contrasting color; and
(iii) a statement of a practical treatment
(first aid or otherwise) in case of poisoning by the
pesticide...
-------
FIFRA - 4
XVI (x) PROTECT HEALTH AND THE ENVIRONMENT. -- "Protect health
and the environment" and "protection of health and the environment"
mean protection against any unreasonable adverse effects on the
environment...
XVI (bb) UNREASONABLE ADVERSE EFFECTS ON THE ENVIRONMENT. ~
"Unreasonable adverse effects on the environment" means any unreason-
able risk to man or the environment, taking into account the economic,
social, and environmental costs and benefits of the use of any
pesticide...
X SEC. 3. REGISTRATION OF PESTICIDES.
(a) REQUIREMENT. — Except as otherwise provided by this Act,
no person in any State may distribute, sell, ship, deliver for
shipment, or receive and (having so received) deliver or offer to
deliver, to any person any pesticide which is not registered with the
Administrator...
(c) PROCEDURES FOR REGISTRATION. —
(1) Statement Required. — Each applicant for registration
of a pesticide shall submit to the Administrator a statement
which includes —
(A) the name and address of the applicant and of any
other person whose name will appear on the labeling;
(B) the name of the pesticide;
XV (C) a complete copy of the labeling of the pesticide,
a statement of all claims to be made for it, and any
directions for its use;
I (D) if requested by the Administrator, a full description
of the tests made and the results thereof upon which the
claims are based...;
(E) the complete formula of the pesticide; and
(F) a request that the pesticide be classified for general
use, for restricted use, or for both.
XII (2) Data In Support Of Registration. — The Administrator
shall publish guidelines specifying the kinds of information
which will be required to support the registration of a pesticide
and shall revise such guidelines from time to time. If thereafter
he requires any additional kind of information, he shall permit
sufficient time for applicants to obtain such additional infor-
mation. Except as provided by subparagraph (c)(1)(D) above and
-------
FIFRA - 5
section 10 below [confidentiality], within 30 days after the
Administrator registers a pesticide under this Act he shall make
available to the public the data called for in the registration
statement together with such other scientific information as
he deems relevant to his decision...
(5) Approval of Registration. — The Administrator shall
register a pesticide if he determines that, when considered with
any restrictions imposed under subsection (d) —
(A) its composition is such as to warrant the proposed
claims for it;
XV
(B) its labeling and other material required to be
submitted comply with the requirements of this Act;
(C) it will perform its intended function without
unreasonable adverse effects on the environment; and
(D) when used in accordance with widespread and
commonly recognized practice it will not generally cause
unreasonable adverse effects on the environment.
(6) Denial Of Registration. — If the Administrator determines
that the requirements of paragraph (5) for registration are not
satisfied, he shall notify the applicant for registration of
his determination and of his reasons (including the factual basis)
therefor, and that, unless the applicant corrects the conditions
and notifies the Administrator during the 30-day period beginning
the day after the date on which the applicant receives the notice,
the Administrator may refuse to register the pesticide...
(4) CLASSIFICATION OF PESTICIDES. —
(1) Classification For General Use, Restricted Use, Or
Both. —
(A) As part of the registration of a pesticide, the
Administrator shall classify it as being for general use
or for restricted use, provided that if the Administrator
determines that some of the uses for which it is registered
should be for general use and that other uses for which
it is registered should be for restricted use, he shall
classify it for both general use and restricted use. If
some of the uses of the pesticide are classified for
general use and other uses are classified for restricted
use, the directions relating to its general uses shall be
clearly separated and distinguished from those directions
^ relating to its restricted uses: Provided, however, that
the Administrator may require that its packaging and
labeling for restricted uses shall be clearly distinguishable
from its packaging and labeling for general uses.
-------
FIFRA - 6
SEC. 4. USE OF RESTRICTED USE PESTICIDES; CERTIFIED APPLICATORS.
(a) CERTIFICATION PROCEDURE. —
(1) Federal Certification. -- Subject to paragraph (2)
below, the Administrator shall prescribe standards for the
certification of applicators of pesticides. Such standards
shall provide that an individual must be determined to be
competent with respect to the use and handling of pesticides,
or to the use and handling of the pesticide or class of
pesticides covered by such individual's certification:
Provided, however, that the certification standard for a private
applicator shall be deemed fulfilled by his completing a certifi-
cation form. The Administrator shall further assure that such form
contains adequate information and affirmations to carry out the
intent of this Act, and may include in the form an affirmation that
the private applicator has completed a training program approved by
the Administrator so long as the program does not require the
private applicator to take, pursuant to a requirement prescribed by
the Administrator, any examination to establish competency in the
use of the pesticide. The Administrator may require any pesticide
dealer participating in a certification program to be licensed
under a State licensing program approved by him.
(2) State Certification. — If any State, at any time,
desires to certify applicators of pesticides, the Governor of
such State shall submit a State plan for such purpose...
SEC. 5. EXPERIMENTAL USE PERMITS.
(a) ISSUANCE. — Any person may apply to the Administrator for
an experimental use permit for a pesticide. The Administrator may
issue an experimental use permit If he determines that the applicant
needs such permit In order to accumulate Information necessary to
register a pesticide under section 3. An application for an
experimental use permit may be filed at the time of or before or
after an application for registration is filed.
(b) TEMPORARY TOLERANCE LEVEL. — If the Administrator
determines that the use of a pesticide may reasonably be expected
to result in any residue on or In food or fuel, he may establish a
temporary tolerance level for the residue of the pesticide before
Issuing an experimental use permit.
-------
FIFRA - 7
(c) USE UNDER PERMIT. — Use of a pesticide under an experimental
use permit shall be under the supervision of the Administrator, and
shall be subject to such terms and conditions and be for such period of
time as the Administrator may prescribe in the permit.
I (d) STUDIES. — When any experimental use permit Is issued for a
XII pesticide containing any chemical or combination of chemicals which has
not been included in any previously registered pesticide, the Administrator
may specify that studies be conducted to detect whether the use of the
pesticide under the permit may cause unreasonable adverse effects on the
environment. All results of such studies shall be reported to the
Administrator before such pesticide may be registered under section 3...
(f) STATE ISSUANCE OF PERMITS. ~ Notwithstanding the foregoing
provisions of this section, the Administrator may, under such terms and
conditions as he may by regulation prescribe, authorize any State to
issue an experimental use permit for a pesticide.
XVH SEC. 6. ADMINISTRATIVE REVIEW; SUSPENSION.
(a) CANCELLATION AFTER FIVE YEARS. — ...
(2) Information. — If at any time after the registration
of a pesticide the registrant has additional factual information
regarding unreasonable adverse effects on the environment of
the pesticide, he shall submit such Information to the
Administrator.
(b) CANCELLATION AND CHANGE IN CLASSIFICATION. ~ If it appears to
the Administrator that a pesticide or its labeling or other material
v' required to be submitted does not comply with the provisions of this Act
or, when used in accordance with widespread and commonly recognized
practice, generally causes unreasonable adverse effects on the
environment, the Administrator may issue a notice of his intent either —
(1) to cancel its registration or to change its classification
together with the reasons (including factual basis) for his action,
or
(2) to hold a hearing to determine whether or not its
registration should be cancelled or its classification changed.
At least 60 days before publishing such notice the Administrator shall
provide the Secretary of Agriculture a copy of the notice along with an
analysis of any impact on the agricultural economy. If the Secretary
comments, the Administrator must publish those comments along with his
response in the Federal Register ...
In taking any final action under this subsection, the Administrator
shall include among those factors to be taken into account the impact of
-------
FIFRA - 8
such final action on production and prices of agricultural commodities,
retail food prices, and otherwise on the agricultural economy, and he
shall publish in the Federal Register an analysis of such impact.
IV (c) SUSPENSION. —
(1) Order. — ...
Except in the case of emergency orders, the Administrator
shall notify the registrant prior to issuing a suspension order.
Such notice shall include findings pertaining to the question of
"imminent hazard". The registrant shall then have an opportunity
for an expedited hearing ...
T (d) PUBLIC HEARINGS AND SCIENTIFIC REVIEW. — In the event a
V hearing is requested pursuant to subsection (b) above or determined upon
by the Administrator,'such hearing shall be held after due notice for
the purpose of receiving evidence relevant and material to the issues
raised by the objections filed by the applicant or other interested
parties, or to the issues stated by the Administrator, if the hearing is
called by the Administrator rather than by the filing of objections.
Upon a showing of relevance and reasonable scope of evidence sought by
IX any party to a public hearing, the Hearing Examiner shall issue a
subpoena to compel testimony or production of documents from any
person...
...Upon the request of any party to a public hearing and when in the
Hearing Examiner's judgment it is necessary or desirable, the Hearing
IV Examiner shall at any time before the hearing record is closed refer to
a Committee of the National Academy of Sciences the relevant questions
of scientific fact involved in the public hearing. The Committee of
the National Academy of Sciences shall report in writing to the Hearing
XIV Examiner within 60 days after such referral on these questions of
scientific fact. The report shall be made public and shall be considered
as part of the hearing record.
X SEC. 7. REGISTRATION OF ESTABLISHMENTS.
(a) REQUIREMENT. — No person shall produce any pesticide subject
to this Act unless the establishment in which it is produced is
registered with the Administrator. The application for registration of
any establishment shall include the name and address of the establish-
ment and of the producer who operates such establishment.
(b) REGISTRATION. — Whenever the Administrator receives an application
under subsection (a), he shall register the establishment and assign it
an establishment number.
XII (c) INFORMATION REQUIRED. —
-------
FIFRA - 9
(1) Any producer operating an establishment registered
under this section shall inform the Administrator within 30
days after it is registered of the types and amounts of
pesticides —
(A) which he is currently producing;
(B) which he has produced during the past year; and
(C) which he has sold or distributed during the past
year.
The information required by this paragraph shall be kept current
and submitted to the Administrator annually as required under
such regulations as the Administrator may prescribe.
(2) Any such producer shall, upon the request of the
Administrator for the purpose of issuing a stop sale order
pursuant to section 13, inform him of the name and address
of any recipient of any pesticide produced in any registered
establishment which he operates.
XIV (d) CONFIDENTIAL RECORDS AND INFORMATION. — Any information
submitted to the Administrator pursuant to subsection (c) shall be
considered confidential and shall be subject to the provisions of
section 10.
SEC. 8. BOOKS AND RECORDS.
(a) REQUIREMENTS. — The Administrator may prescribe regulations
requiring producers to maintain such records with respect to their
operations and the pesticides and devices produced as he determines are
necessary for the effective enforcement of this Act. No records
required under this subsection shall extend to financial data, sales
data other than shipment data, pricing data, personnel data, and
research data (other than data relating to registered pesticides or to a
pesticide for which an application for registration has been filed).
VIII (b) INSPECTION. — For the purposes of enforcing the provisions of
this Act, any producer, distributor, carrier, dealer, or any other
person who sells or delivers any pesticide or device subject to this
Act, shall, upon request of any officer of the Environmental Protection
Agency or of any State or political subdivision designated by the
Administrator, furnish or permit such person at all reasonable times to
have access to, and to copy: (1) all records showing the delivery,
movement, or holding of such pesticide or device, including the quantity,
the date of shipment and receipt, and the name of the consignor and
consignee; or (2) in the event of the inability of any person to produce
records containing such information, all other records and information
relating to such delivery, movement, or holding of the pesticide or
device. Any inspection with respect to any records and information
-------
FIFRA - 10
referred to in this subsection shall not extend to financial data, sales
data other than shipment data, pricing data, personnel data, and
research data (other than data relating to registered pesticides or to a
pesticide for which an application for registration has been filed).
VIII SEC> 9' INSPECTION OF ESTABLISHMENTS, ETC.
(a) IN GENERAL. — For purposes of enforcing the provisions of this
Act, officers of EPA are authorized to enter at reasonable times, any
establishment or other place where pesticides or devices are held for
distribution or sale for the purpose of inspecting and obtaining samples
of any pesticides or devices, packaged, labeled, and released for
shipment, and samples of any containers or labeling for such pesticides
or devices.
... If the officer obtains any samples, prior to leaving the premises,
he shall give the owner, operator, or agent in charge a receipt
describing the samples obtained and, if requested, a portion of each
sample equal in volume or weight to the portion retained. If an
analysis is made of such samples, a copy of the results of such analysis
shall be furnished promptly to the owner, operator, or agent in charge.
(b) WARRANTS. — For purposes of enforcing the provisions of this
Act and upon a showing to an officer or court of competent jurisdiction
that there is reason to believe that the provisions of this Act have
been violated, officers or employees duly designated by the Administrator
are empowered to obtain and to execute warrants authorizing —
(1) entry for the purpose of this section;
(2) inspection and reproduction of all records showing
the quantity, date of shipment, and the name of consignor and
consigneee of any pesticide or device found in the establishment
which is adulterated, misbranded, not registered (in the case
of a pesticide) or otherwise in violation of this Act and
in the event of the inability of any person to produce records
containing such information, all other records and information
relating to such delivery, movement, or holding of the
pesticide or device...
XIV SEC. 10. PROTECTION OF TRADE SECRETS AND OTHER INFORMATION.
(a) IN GENERAL. — In submitting data required by this Act, the
applicant may (1) clearly mark any portions thereof which in his opinion
are trade secrets or commercial or financial information, and (2) submit
such marked material separately from other material required to be
submitted under this Act.
-------
FIFRA - 11
(b) DISCLOSURE. — Notwithstanding any other provision of this
Act, the Administrator shall not make public information which in his
judgment contains or relates to trade secrets or commercial or financial
information obtained from a person and privileged or confidential,
except that, when necessary to carry out the provisions of this Act,
information relating to formulas of products acquired by authorization
of this Act may be revealed to any Federal agency consulted and may be
revealed at a public hearing or in findings of fact issued by the
Administrator.
(c) DISPUTES. — If the Administrator proposes to release for
inspection information which the applicant or registrant believes to be
protected from disclosure under subsection (b), he shall notify the
applicant or registrant, in writing, by certified mail. The Administrator
shall not thereafter make available for inspection such data until
thirty days after receipt of the notice by the applicant or registrant.
During this period, the applicant or registrant may institute an action
in an appropriate district court for a declaratory judgment as to
whether such information is subject to protection under subsection (b).
SEC. 11. STANDARDS APPLICABLE TO PESTICIDE APPLICATORS.
XII (a) IN GENERAL. — No regulations prescribed by the Administrator
for carrying out the provisions of this Act shall require any private
applicator to maintain any records or file any reports or other documents.
XVII SEC. 12. UNLAWFUL ACTS.
(a) IN GENERAL. —
(1) Except as provided by subsection (b), it shall be
unlawful for any person in any State to distribute, sell, offer
for sale, hold for sale, ship, deliver for shipment, or receive
and (having so received) deliver or offer to deliver, to any
person —
(A) any pesticide which is not registered under
section 3, except as provided by subsection 6(a)(l);
(B) any registered pesticide if any claims made for it
as a part of its distribution or sale substantially differ
from any claims made for it as a part of the statement
required in connection with its registration ...;
(C) any registered pesticide the composition of which
differs at the time of its distribution or sale from its
composition as described in the statement required in
connection with its registration...;
-------
FIFRA - 12
XIV (D) any pesticide which has not been colored or
discolored pursuant to the provisions of section 25(c)(5);
(E) any pesticide which is adulterated or misbranded; or
(F) any device which is misbranded.
(2) It shall be unlawful for any person —
(A) to detach, alter, deface, or destroy, in whole or
in part, any labeling required under this Act;
(B) to refuse to keep any records required pursuant
to section 8, or to refuse to allow the inspection of any
records or establishment pursuant to section 8 or 9, or
to refuse to allow an officer or employee of the Environmental
Protection Agency to take a sample of any pesticide pursuant
to section 9...; ...
(D) to use for his own advantage or to reveal, other
than to the Administrator, or officials or employees of
the Environmental Protection Agency or other Fede.ral
executive agencies, or to the courts, or to physicians,
pharmacists, and and other qualified persons, needing such
information for the performance of their duties, in
accordance with such directions as the Administrator
may prescribe, any information acquired by authority of
this Act which is confidential under this Act;
(E) who is a registrant, wholesaler, dealer, retailer,
or other distributor to advertise a product registered under
this Act for restricted use without giving the classification
of the product assigned to it under section 3;
(F) to make available for use, or to use, any registered
pesticide classified for restricted use for some or all
purposes other than in accordance with section 3(d) and any
regulations thereunder;
(G) to use any registered pesticide in a manner incon-
sistent with its labeling;
(H) to use any pesticide which is under an experimental
use permit contrary to the provisions of such permit;
(I) to violate any stop sale, stop use, removal or
seizure order issued by the Administrator under section 13;
(J) to violate any suspension order issued under
section 6;
-------
FIFRA - 13
(K) to violate any cancellation of registration of a
pesticide under section 6, except as provided by section
(L) who is a producer to violate any of the provisions
of section 7 [registration of establishments];
(M) to knowingly falsify all or part of any application
for registration, application for experimental use permit,
any information submitted to the Administrator pursuant to
section 7, any records required to be maintained pursuant to
section 8, any report filed under this Act, or any information
marked as confidential and submitted to the Administrator under
any provision of this Act; \
(N) who is a registrant, wholesaler, dealer, retailer, or
other distributor to fail to file reports required by this
Act;
(0) to add any substance to, or take a substance from,
any pesticide in a manner that may defeat the purpose of
this Act; or
XI (P) to use any pesticide in tests on human beings
unless such human beings (i) are fully informed of the
nature and purposes of the test and of any physical and
mental health consequences which are reasonably foreseeable
therefrom, and (ii) freely volunteer to participate in
the test.
XVII SEC. 17. IMPORTS AND EXPORTS
(a) PESTICIDES AND DEVICES INTENDED FOR EXPORT. — Notwithstanding
any other provision of this Act, no pesticide or device shall be deemed
in violation of this Act when intended solely for export to any foreign
country and prepared or packed according to the specifications or
directions of the foreign purchaser, except that producers of such
pesticides and devices shall be subject to section 8 of this Act
(regarding keeping records and books and inspections)...
XI (b) CANCELLATION NOTICES FURNISHED TO FOREIGN GOVERNMENTS. —
Whenever a registration, or a cancellation or suspension of the
registration of a pesticide becomes effective, or ceases to be
effective, the Administrator shall transmit through the State Department
notification thereof to the governments of other countries and to
appropriate international agencies.
-------
FIFRA - 14
(c) IMPORTATION OF PESTICIDES AND DEVICES. — The Secretary of the
Treasury shall notify the Administrator of the arrival of pesticides and
devices and shall deliver to the Administrator, upon his request,
samples of pesticides or devices which are being imported into the
United States, giving notice to the owner or consignee, who may appear
before the Administrator and have the right to introduce testimony.
Ill (d) COOPERATION IN INTERNATIONAL EFFORTS. — The Administrator
shall, in cooperation with the Department of State and any other
appropriate Federal agency, participate and cooperate in any inter-
national efforts to develop improved pesticide research and regulations.
(e) REGULATIONS. — The Secretary of the Treasury, in consultation
with the Administrator, shall prescribe regulations for the enforcement
of subsection (c) above.
II SEC. 20. RESEARCH AND MONITORING.
(a) RESEARCH. — The Administrator shall undertake research,
including research by grant or contract with other Federal agencies,
universities, or others as may be necessary to carry out the purposes of
this Act, and he shall give priority to research to develop biologically
integrated alternatives for pest control. The Administrator shall also
take care to insure that such research does not duplicate research being
undertaken by any other Federal agency.
(b) NATIONAL MONITORING PLAN. — The Administrator shall formulate
and periodically revise, in cooperation with other Federal, State, or
local agencies, a national plan for monitoring pesticides.
V (c) MONITORING. — The Administrator shall undertake such monitoring
activities, including but not limited to monitoring in air, soil, water,
man, plants, and animals, as may be necessary for the implementation of
this Act and of the national pesticide monitoring plan. Such activities
shall be carried out in cooperation with other Federal, State, and local
agencies.
SEC. 21. SOLICITATION OF COMMENTS; NOTICE OF PUBLIC
HEARINGS.
Ill (a) The Administrator, before publishing regulations under this
Act, shall solicit the views of the Secretary of Agriculture in
accordance with the procedure described in section 25(a) below.
-------
FIFRA - 15
SEC. 25. AUTHORITY OF ADMINISTRATOR.
VII (a) (1) REGULATIONS. — The Administrator is authorized in
accordance with the procedure described in paragraph (2), to
prescribe regulations to carry out the provisions of this Act.
Such regulations shall take into account the difference in
concept and usage between various classes of pesticides...
,.,.,. (2) Prior to publishing any proposed or final regulations
under this subsection, the Administrator shall provide the
Secretary of Agriculture an opportunity to comment. Any comments
received shall be published with the proposal for final regulation
along with the Administrator's response. ..
(c) OTHER AUTHORITY. — The Administrator, after notice and
opportunity for hearing, is authorized
(3) to establish standards (which shall be consistent with
those established under the authority of.the Poison Prevention
Packaging Act, Public Law 91-601) with respect to the package,
container, or wrapping in which a pesticide or device is enclosed
for use or consumption, in order to protect children and
adults from serious injury or illness resulting from accidental
ingestion or contact with pesticides or devices regulated by
this Act as well as to accomplish the other purposes of this Act;
(4) to specify those classes of devices which shall be
subject to any provision of paragraph 2(q)(l) [packaging and
labeling] or section 7 [registration of establishments] of this
Act upon his determination that application of such provision
is necessary to effectuate the purposes of this Act;
yy (5) to prescribe regulations requiring any pesticide to be
colored or discolored if he determines that such requirement is
feasible and is necessary for the protection of health and the
environment; and
II (6) to determine and establish suitable names to be used in
the ingredient statement.
-------
As Amended by
PUBLIC LAW 95-95 — August 7, 1977
"THE CLEAN AIR ACT"
TITLE I ~ AIR POLLUTION PREVENTION AND CONTROL
PART A — AIR QUALITY AND EMISSION LIMITATIONS
RESEARCH, INVESTIGATION, TRAINING, AND
OTHER ACTIVITIES
IV SEC. 103.
(a) The Administrator shall establish a national research and
development program for the prevention and control of air pollution
and as part of such program shall —
(1) conduct and promote the coordination and acceleration
of research, investigations, experiments, demonstrations, surveys,
and studies relating to the causes, effects, extent, prevention, and
control of air pollution; ...
(3) conduct investigations and research and make surveys
concerning any specific problem of air pollution in cooperation
with any air pollution control agency with a view to recommending a
solution of such problem, if he is requested to do so by such
agency or if, in his judgment, such problem may affect any
community or communities in a State other than that in which the
source of the pollution is located; ...
(b) In carrying out the provisions of the preceding subsection the
Administrator is authorized to —
(1) collect and make available, through publications and
other appropriate means, the results of and other information
pertaining to such research and other activities (including
appropriate recommendations by him);
(2) cooperate with other Federal departments and agencies,
with air pollution control agencies, with other public and private
agencies, institutions, and organizations, and with any industries
involved, in the preparation and conduct of such research and other
activities;
-------
CAA - 2
(3) make grants to air pollution control agencies, to other
public or nonprofit private agencies, institutions, and organizations,
and to individuals, for purposes stated in subsection (a)(1) above;
(4) contract with public or private agencies, institutions,
or organizations, and with individuals; ...
(6) collect and disseminate, in cooperation with other
Federal departments and agencies, and with other public or private
agencies, institutions, and organizations having related respon-
sibilities, basic data on chemical, physical, and biological
effects of varying air quality and other information pertaining to
air pollution and the prevention and control thereof...
(c) In carrying out the provisions of subsection (a) of this
section the Administration [sic] shall conduct research on, and survey
the results of other scientific studies on, the harmful effects on the
health or welfare of persons by the various known air pollutants.
(d) The Administrator is authorized to construct such facilities
and staff and equip them as he determines to be necessary to carry out
his functions under this Act.
(e) If, in the judgment of the Administrator, an air pollution
problem of substantial significance may result from discharge or
discharges into the atmosphere, he may call a conference concerning this
potential air pollution problem to be held in or near one or more of the
places where such discharges are occurring. All interested persons
shall be given an opportunity to be heard at such conference, either
orally or in writing, and shall be permitted to appear in person or by
representative. If the Administrator finds, on the basis of evidence
presented at such conference, that the discharge or discharges, if
permitted, are likely to cause or contribute to air pollution subject to
abatement under section 115, he shall send such findings, together with
recommendations concerning the measures which he finds reasonable and
suitable to prevent such pollution, to the person or persons whose
actions will result in the discharge or discharges involved; to air
pollution agencies of the State or States and of the municipality or
municipalities where such discharge or discharges will originate; and to
the interstate air pollution control agency, if any, in the jurisdictional
area of which any such municipality is located. Such findings and
recommendations shall be advisory only...
(f) (1) In carrying out research pursuant to this Act, the
Administrator shall give special emphasis to research on the
short- and long-term effects of air pollutants on public health
and welfare. In the furtherance of such research, he shall
conduct an accelerated research program —
(A) to improve knowledge of the contribution of air
pollutants to the occurrence of adverse effects on health,
xncluding, but not limited to, behavioral physiological,
toxicological, and biochemical effects; and
-------
CM - 3
(B) to improve knowledge of the short- and long-term
effects of air pollutants on welfare.
(2) In carrying out the provisions of this subsection the
Administrator may —
(A) conduct epidemiological studies of the effects
of air pollutants on mortality and morbidity;
(B) conduct clinical and laboratory studies on the
immunological, biochemical, physiological, and the toxicological
effects including carcinogenic, teratogenic, and mutagenic
effects of air pollutants;
(C) utilize, on a reimbursable basis, the facilities
of existing Federal scientific laboratories and research
centers;
(D) utilize the authority contained in paragraphs (1)
through (4) of subsection (b) above; and
(E) consult with other appropriate Federal agencies
to assure that research of studies conducted pursuant to
this subsection will be coordinated with research and studies
of such other Federal agencies.
AIR QUALITY CRITERIA AND CONTROL TECHNIQUES
n SEC. 108...
(a) (1) ... the Administrator shall publish, and keep current,
a list including each air pollutant —
(A) which, causes or contributes to air pollution
endangering public health or welfare;
(B) which results from numerous or diverse mobile
or stationary sources; and
(C) ... for which he plans to issue air quality
criteria under this section.
(2) The Administrator shall issue air quality criteria
for an air pollutant within 12 months after he has included such
pollutant in a list under paragraph (1). Air quality criteria
shall reflect the latest scientific knowledge indicating the kind
and extent of effects on public health or welfare expected from the
presence of such pollutant. The criteria shall include information
on —
-------
CAA - 4
(A) variable factors (including atmospheric conditions)
which may alter the effects of such air pollutant;
(B) the types of air pollutants which may interact
with such pollutant to produce an adverse effect; and
(C) any known or anticipated adverse effects.
(b) (1) With the issuance of criteria the Administrator shall,
after consultation with appropriate advisory committees and Federal
departments and agencies, issue to the States and appropriate air
pollution control agencies information on air pollution control
techniques, which information shall include data relating to the
cost of installation and operation, energy requirements, emission
reduction benefits, and environmental impact of the emission
control technology. Such information shall include available data
on available technology and alternative methods of prevention and
control of air pollution, and also include data on alternative
fuels, processes, and operating methods which will result in
elimination or significant reduction of emissions.
(2) To assist in the development of information on pollution
control techniques, the Administrator may establish a standing
consulting committee for each air pollutant listed, comprised of
technically qualified individuals representative of State and local
governments, industry, and the economic community.
(c) The Administrator shall from time to time review, and, as
appropriate, modify, and reissue any criteria or information on control
techniques issued pursuant to this section...
(f) (1) The Administrator shall publish and make available
to appropriate Federal agencies, States, and air pollution
control agencies,...
(C) information on measures which may be employed
to reduce the impact of air pollution on public health
or protect the health of sensitive or susceptible
individuals or groups; and
(D) information on the extent to which any process,
procedure, or method to reduce or control such air pollutant
may cause an increase in the emissions or formation of any
other pollutant.
(2) In publishing such information the Administrator shall
also include an assessment of —
(A) the relative effectiveness of such processes, pro-
cedures, and methods; ...
-------
CAA - 5
(C) the environmental, energy, and economic impact of
such processes, procedures, and methods.
NATIONAL AMBIENT AIR QUALITY STANDARDS
IV SEC. 109...
(d) (2) (A) The Administrator shall appoint an independent
scientific review committee composed of seven members
including at least one member of the National Academy of
Sciences, one physician, and one person representing State air
pollution control agencies.
(B) Not later than January 1, 1980, and at five-year
intervals thereafter, the committee shall complete a review of
the [air quality] criteria published under section 108 and the
national primary and secondary ambient air quality standards
promulgated under this section and shall recommend to the
Administrator any new national ambient air quality standards
and revisions of existing criteria and standards as may be
appropriate under section 108 and subsection (b) of this
section.
(C) Such committee shall also (i) advise the Administrator
of areas in which additional knowledge is required to appraise
the adequacy and basis of existing, new, or revised national
ambient air quality standards, (ii) describe the research
efforts necessary to provide the required information, (iii)
advise the Administrator on the relative contribution to air
pollution concentrations of natural as well as anthropogenic
activity, and (iv) advise the Administrator of any adverse
public health, welfare, social, economic, or energy effects
which may result from various strategies for attainment and
maintenance of such national ambient air quality standards.
IMPLEMENTATION PLANS
SEC. 110.
(a) (1) Each State shall, after reasonable notice and public
hearings, adopt and submit to the Administrator, within nine
months after the promulgation of a national primary ambient air
quality standard for any air pollutant, a plan which provides for
implementation maintenance, and enforcement of such primary
standard in each air quality control region within such State.
(2) The Administrator shall, within four months after the
date required for submission of a plan under paragraph (1), approve
or disapprove such plan or each portion thereof. The Administrator
shall approve such plan, or any portion thereof, if he determines
that it was adopted after reasonable notice and hearing and that —
-------
CM - 6
(C) it includes provisions for establishment and
operation of appropriate devices, methods, systems, and
procedures necessary to (i) monitor, compile, and analyze data
on ambient air quality and, (ii) upon request, make such data
available to the Administrator;
X (D) it includes a program to provide for the enforcement
of emission limitations and regulation of the modification,
construction, and operation of any stationary source,
including a permit program as required in parts C and D of
this act, and a permit or equivalent program for any major
emitting facility, within such region as necessary to assure
(i) that national ambient air quality standards are achieved
and maintained; and (ii) that a procedure for review of the
location of new sources to which a standard of performance
will apply prior to construction or modification;...
V (F) ... (ii) it provides requirements for installation of
XI1 equipment by owners or operators of stationary sources to
1 monitor emissions from such sources, (iii) for periodic reports
on the nature and amounts of such emissions; (iv) that such
reports shall be correlated by the State agency with any
emission limitations or standards established pursuant to this
Act, which reports shall be available at reasonable times for
public inspection; ...
(4) The procedure referred to in paragraph (2)(D) for review,
prior to construction or modification, of the location of new
sources shall (A) provide for adequate authority to prevent the
construction or modification of any new source to which a standard
of performance under section 111 will apply at any location which
the State determines will prevent the attainment or maintenance
within any air quality control region within such State of a
national ambient air quality primary or secondary standard, and (B)
require that prior to commencing construction or modification of
any such source, the owner or operator shall submit to such State
such information as may be necessary to permit the State to make a
determination under clause (A) in this subparagraph...
(j) As a condition for issuance of any permit, the owner or
operator of each new or modified stationary source must show to the
satisfaction of the permitting authority that the proposed technological
system of continuous emission reduction will enable such source to
comply with standards of performance which are to apply and that the
construction or modification and operation of such source will be in
compliance with all other requirements of this Act.
-------
CAA - 7
STANDARDS OF PERFORMANCE FOR NEW
STATIONARY SOURCES
II SEC. 111...
(b) (1) (A) The Administrator shall publish (and from time
to time thereafter shall revise) a list of categories
of stationary sources. He shall include a category of sources
in such list if in his judgment it causes, or contributes
significantly to, air pollution which may reasonably be
anticipated to endanger public health or welfare...
(f) (2) In determining priorities for promulgating standards
of performance for categories of major stationary sources the
Administrator shall consider —
(A) the quantity of air pollutant emissions which
each such category will emit, or will be designed to emit;
(B) the extent to which each such pollutant may
reasonably be anticipated to endanger public health or
welfare; and
(C) the mobility and competitive nature of each such
category of sources and the consequent need for nationally
applicable new source standards of performance...
(g) (5) Upon application by the Governor of a State showing that
the Administrator has failed to list any air pollutant which
causes, or contributes to, air pollution which may reasonably be
anticipated to result in an increase in mortality or an increase in
serious irreversible, or incapacitating reversible, illness as a
hazardous air pollutant under section 112, the Administrator shall
revise the list of hazardous air pollutants under such section to
include such pollutant...
(7) Unless later deadlines for action of the Administrator
are otherwise prescribed under this section or section 112, the
Administrator shall, not later than three months following the date
of receipt of any application by a Governor of a State, either —
(A) find that such application does not contain the
requisite showing and deny such application, or
(B) grant such application and take the action required
under this subsection...
-------
CAA - 8
(j; (1) (A) Any person proposing to own or operate a new source
may request the Administrator for waivers from the require-
ments of this section for such source with respect to any air
pollutant to encourage the use of an innovative technological
system or systems of continuous emission reduction. The
Administrator may grant a waiver if he determines that — ...
(iii) the owner or operator of the proposed
source has demonstrated to the satisfaction of the
Administrator that the proposed system will not cause
or contribute to any unreasonable risk to public health,
welfare, or safety in its operation, function, or
malfunction, and...
... The Administrator may conduct such tests and may require
the owner or operator of the proposed source to conduct such
tests and provide such information as is necessary to carry
out clause (iii) above, of this subparagraph. Such require-
ments shall include a requirement for prompt reporting of the
emission of any unregulated pollutant from a system if such
pollutant was not emitted, or was emitted in significantly
lesser amounts without the use of such system...
NATIONAL EMISSION STANDARDS FOR HAZARDOUS
AIR POLLUTANTS
SEC. 112.
(a) For purposes of this section —
(1) "Hazardous air pollutant" means an air pollutant for
which no ambient air quality standard is applicable and which in
the judgment of the Administrator causes, or contributes to, air
pollution which may reasonably be anticipated to result in an
increase in mortality or an increase in serious irreversible, or
incapaciting reversible, illness...
(b) (1) (A) The Administrator shall publish (and shall from time
to time thereafter revise) a list which includes each
hazardous air pollutant for which he intends to establish
an emission standard under this section.
Iv (B) Within 180 days after the inclusion of any air
pollutant in the list, the Administrator shall publish
proposed regulations establishing emission standards for such
pollutant together with a notice of public hearing within
-------
CAA - 9
thirty days. Not later than 180 days after such publication,
the Administrator shall prescribe an emission standard, unless
he finds, on the basis of information presented at such hearings,
that such pollutant clearly is not a hazardous air pollutant.
The Administrator shall establish any standard at the level
which provides an ample margin of safety to protect the public
health.
(C) Any emission standard established pursuant to this
section shall become effective upon promulgation.
(2) The Administrator shall, from time to time, issue infor-
mation on pollution control techniques for air pollutants subject
to the provisions of this section.
XVII (c) (1) After the effective date of any emission standard
under this section —
(A) no person may construct any new source or modify
any existing source which will emit an air pollutant to which
a standard applies unless the Administrator finds that such
source if properly operated will not cause emissions in
violation of such standard, and
(B) no air pollutant to which such standard applies may
be emitted from any stationary source in violation of such
standard, except that in the case of an existing source —
(i) such standard shall not apply until 90 days
after its effective data, and
X (ii) the Administrator may grant a waiver permitting
such source up to two years to comply with the standard,
if he finds that such period is necessary for the
installation of controls and that steps will be taken
during the period of the waiver to assure that the health
of persons will be protected from imminent danger...
INSPECTIONS, MONITORING, AND ENTRY
SEC. 114.
(a) For the purpose (i) of developing or assisting in the develop-
ment of any implementation plan, any standard of performance, or any
emission standard, (ii) of determining whether any person is in
violation of any such standard or any requirement of a plan, or (iii) of
carrying out any provision of this Act —
-------
CAA - 10
VII (1) the Administrator may require any person who owns or
V operates any emission source or who is subject to any requirement
of this Act to (A) establish and maintain such records, (B) make
XII such reports, (C) install, use, and maintain such monitoring
equipment or methods, (D) sample such emissions (in accordance with
such methods, at such locations, at such intervals, and in such
manner as the Administrator shall prescribe), and (E) provide such
other information, as he may reasonably require; and
VIII (2) the Administrator or his authorized representative, upon
presentation of his credentials —
(A) shall have a right of entry to, upon, or through any
premises of such person or in which any records required to be
maintained under paragraph (1) of this section are located,
and
(B) may at reasonable times have access to and copy any
records, inspect any monitoring equipment and method required
under paragraph (1), and sample any emissions which such
person is required to sample under paragraph (1). ..
(c) Any records, reports, or information obtained under subsection
(a) shall be available to the public, except that upon a showing
satisfactory to the Administrator by any person that records, reports,
or information, or particular part thereof, (other than emission data)
to which the Administrator has access under this section if made public
would divulge methods or processes entitled to protection as trade
secrets, the Administrator shall consider such information confidential
in accordance with the purposes of section 1905 of title 18 of the
United States Code, except that such information may be disclosed to
other officers, employees, or authorized representatives of the United
States concerned with carrying out this Act or when relevant in any
proceeding under this Act.
PRESIDENT'S AIR QUALITY ADVISORY BOARD AND
ADVISORY COMMITTEES
IV SEC. 117.
(a) In order to obtain assistance in the development and imple-
mentation of the purposes of this Act including air quality criteria,
recommended control techniques standards, research and development, and
to encourage the continued efforts on the part of industry to improve
-------
CAA - 11
air quality and to develop economically feasible methods for the control
and abatement of air pollution, the Administrator shall from time to
time establish advisory committees. Committee members shall include, but
not be limited to, persons who are knowledgable concerning air quality
from the standpoint of health, welfare, economics, or technology...
(c) Prior to —
(1) issuing criteria for an air pollutant under paragraph
108(a)(2),
(2) publishing any list under subparagraph lll(b)(l)(A) or
(3) publishing any standard under subparagraph lll(b)(l)(B)
or subparagraph 112(b) (1) (B) . . .
the Administrator shall, to the maximum extent practicable within the
time provided, consult with appropriate advisory committees, independent
experts, and Federal departments and agencies.
PART B ~ OZONE PROTECTION
STUDIES BY ENVIRONMENTAL PROTECTION AGENCY
SEC. 153.
(a) The Administrator shall conduct a study of the cumulative
effect of all substances, practices, processes, and activities which may
affect the stratosphere, especially ozone in the stratosphere. The
study shall include an analysis of the independent effects on the
stratosphere, especially such ozone in the stratosphere of —
(1) the release into the ambient air of halocarbons,
(2) the release into the ambient air of other sources
of chlorine,
(3) the uses of bromine compounds, and
(4) emissions of aircraft and aircraft propulsion systems
employed by operational and experimental aircraft.
-------
CAA - 12
The study shall also include such physical, chemical, atmospheric,
biomedical, or other research and monitoring as may be necessary to
ascertain (A) any direct or indirect effects upon the public health and
welfare of changes in the stratosphere, especially ozone in the
stratosphere, and (B) the probable causes of changes in the stratosphere,
especially the ozone in the stratosphere.
(b) The Administrator shall undertake research on —
(1) methods to recover and recycle substances which directly
or indirectly affect the stratosphere, especially ozone in the
stratosphere,
(2) methods of preventing the escape of such substances,
(3) safe substitutes for such substances, and
(4) other methods to regulate substances, practices, processes,
and activities which may reasonably be anticipated to affect the
stratosphere, especially ozone in the stratosphere...
RESEARCH AND MONITORING BY OTHER AGENCIES
II SEC. 154.
(a) The Administrator of the National Oceanic and Atmospheric
Administration shall establish a continuing program of research and
monitoring of the stratosphere for the purpose of early detection of
changes in the stratosphere and climatic effects of such changes. Such
Administrator shall on or before January 1, 1978, and biennially
thereafter, transmit a report to the Administrator and the Congress on
the findings of such research and monitoring. Such report shall contain
any appropriate recommendations for legislation or regulation.
(b) The National Aeronautics and Space Administration shall
continue programs of research, technology, and monitoring of the
stratosphere for the purpose of understanding the physics and chemistry
of it and for the early detection of potentially harmful changes in the
ozone in it. Such Administration shall transmit reports by January 1,
1978, and biennially thereafter, to the Administrator and the Congress
on the results of the programs authorized in this subsection, together
with any appropriate recommendations for legislation or regulation.
(c) The Director of the National Science Foundation shall
encourage and support ongoing stratospheric research programs and
continuing research programs that will increase scientific knowledge of
the effects of changes in the ozone layer in the stratosphere upon
living organisms and ecosystems. Such Director shall transmit reports by
-------
CAA - 13
January 1, 1978, and biennially thereafter, to the Administrator and the
Congress on the results of such programs, together with any appropriate
recommendations for legislation or regulation.
(d) The Secretary of Agriculture shall encourage and support
continuing research programs that will increase scientific knowledge of
the effects of changes in the ozone in the stratosphere upon animals,
crops, and other plant life. Such Secretary shall transmit reports by
January 1, 1978, and biennially thereafter, to the Administrator and the
Congress on the results of such programs, together with any appropriate
recommendations for legislation or regulation.
(e) The Secretary of Health, Education, and Welfare shall
encourage and support continuing research programs that will increase
scientific knowledge of the effects of changes in the ozone in the
stratosphere upon human health. Such Secretary shall transmit reports
by January 1, 1978, and biennially thereafter, to the Administrator and
the Congress on the results of such programs, together with any
appropriate recommendations for legislation or regulation.
(f) In carrying out subsection (a) through (e) of this section,
the agencies involved (1) shall enlist and encourage cooperation and
assistance from other Federal agencies, universities, and private
industry, and (2) shall solicit the views of the Administrator with
regard to plans for the research involved so that any such research
will, if regulatory action by the Administrator is indicated, provide
the preliminary information base for such action.
PART C — PREVENTION OF SIGNIFICANT DETERIORATION
OF AIR QUALITY
SUBPART 1
* * *
PRECONSTRUCTION REQUIREMENTS
SEC. 165.
(a) No major emitting facility on which construction is commenced
after the date of the enactment of this part, may be constructed in any
area to which this part applies unless —
(1) a permit has been issued setting forth emission
limitations for such facility;
-------
CAA - 14
(2) the proposed permit has been subject to a review in
accordance with this section, the required analysis has been
conducted in accordance with regulations prpmulgated by the
Administrator, and a public hearing has been held with opportunity
for interested persons including representatives of the Admin-
istrator to appear and submit written or oral presentations on the
air quality impact of such source, alternatives thereto, control
technology requirements, and other appropriate considerations;
(3) the owner or operator of such facility demonstrates, that
emissions from construction or operation of such facility will not
cause, or contribute to, air pollution in excess of any (A) maximum
allowable increase or maximum allowable concentration for any
pollutant in any area to which this part applies more than one time
per year, (B) national ambient air quality standard in any air
quality control region, or (C) any other applicable emission
standard of performance under this Act;
(4) the proposed facility is subject to the best available
control technology for each pollutant subject to regulation under
this Act emitted from, or which results from, such facility;
(5) the provisions of subsection (d) with respect to
protection of class I areas have been complied with for such
facility;
(6) there has been an analysis of any air quality impacts
projected for the area as a result of growth associated with such
facility;
(7) the owner or operator agrees to conduct such monitoring
as may be necessary to determine the effect which emissions from
any such facility may have on air quality in any areas which may be
affected by emissions for such source; and
(8) . . . the Administrator has approved the determination of
best available technology as set forth in the permit...
(e) (1) The review provided for in subsection (a) above shall be
preceded by an analysis, in accordance with regulations of the
Administrator, conducted by any general purpose unit of local
government or by the applicant, of the ambient air quality at the
proposed site and in areas which may be affected by emissions from
such facility for each pollutant subject to regulation under this
Act which will be emitted from such facility. . .
(3) The Administrator shall promulgate regulations respecting
the analysis which — ...
-------
CAA - 15
(B) shall require analysis of the ambient air quality,
climate and meteorology, terrain, soils, and vegetation, and
visibility at the site of the proposed major emitting facility
and in the area potentially affected by the emissions from
such facility for each pollutant regulated under this Act,
which will be emitted from, or which results from the con-
struction or operation of, such facility, the size and nature
of the proposed facility, and such other factors as may be
relevant in determining the effect of emissions from a
proposed facility on any air quality control region...
PART D — PLAN REQUIREMENTS FOR NONATTAINMENT
AREAS
DEFINITIONS
SEC. 171.
For the purpose of this part and subpatagraph 110(a)(2)(I) above —
XVI (1) "Reasonable further progress" means annual incremental
reductions in emissions of the applicable air pollutant (including
substantial reductions in the early years following approval or
promulgation of plan provisions under this part and subparagraph
110(a)(2)(I) above, and regular reductions thereafter) which are
sufficient, in the judgment of the Administrator to provide for
attainment of the applicable national ambient air quality standard..
I
NONATTAINMENT PLAN PROVISIONS
SEC. 172...
(b) The plan provisions required by subsection (a) above shall —
• • •
(1) be adopted by the State after reasonable notice and
public hearing;...
XII (4) include a comprehensive, accurate, current inventory
of actual emissions from all sources of each such pollutant for
each such area...;
V (5) expressly identify and quantify the emissions, if any, of
any such pollutant which will be allowed to result from the
construction and operation of major new or modified stationary
sources for each such area;
-------
CAA ~ 16
X (6) require permits for the construction and operation of new
or modified major stationary sources in accordance with section 173
(relating to permit requirements);...
PERMIT REQUIREMENTS
X SEC. 173.
The permit program required by paragraph 172(b)(6) above shall
provide that permits to construct and operate may be issued if —
(1) the permitting agency determines that —
(A) by the time the source is to commence operation,
total allowable emissions from existing sources in the region,
from new or modified sources which are riot major emitting
facilities, and from the proposed source will be sufficiently
less than total emissions from existing sources prior to the
application as to represent (when required under section 172)
reasonable further progress; or
(B) that emissions resulting from the proposed new or
modified major stationary source will not cause or contribute
to emission levels which exceed the allowance permitted for
such pollutant for such area from new or modified major
stationary sources under subsection 172(b) above;
(2) the proposed source is required to comply with the lowest
achievable emission rate;
(3) the owner or operator of the proposed new or modified
source has demonstrated that all major stationary sources owned or
operated by such persons in such State are subject to emission
limitations and are in compliance, or on a schedule for compliance,
with all applicable emission limitations and standards under this
Act; and ...
Any emission reductions required as a precondition of the issuance of a
permit under subparagraph (1)(A) above shall be legally binding before
such permit may be issued.
REGULATION OF FUELS
X SEC. 211.
(a) The Administrator may by regulation designate any fuel or fuel
additive and, after such date or dates as may be prescribed by him, no
-------
CAA - 17
manufacturer or processor of any such fuel or additive may sell, offer
for sale, or introduce into commerce such fuel or additive unless the
Administrator has registered such fuel or additive in accordance with
subsection (b) of this section.
(b) (1) For the purpose of registration of fuels and fuel
additives, the Administrator shall require —
(A) the manufacturer of any fuel to notify him
as to the commercial identifying name and manufacturer
of any additive contained in such fuel; the range
of concentration of any additive in the fuel; and the
purpose-in-use of any such additive; and
(B) the manufacturer of any additive to notify
him as to the chemical composition of such additive.
(2) For the purpose of registration of fuels and fuel
additives, the Administrator may also require the manufacturer
of any fuel or fuel additive —
I (A) to conduct tests to determine potential public
health effects of such fuel or additive (including, but
not limited to, carcinogenic, teratogenic, or mutagenic
effects), and
XII (B) to furnish a description of any analytical
technique that can be used to detect and measure any
additive in such fuel, the recommended range of concentration
of such additive, and the recommended purpose-in-use of such
additive, and such other information as is reasonable and
necessary to determine the emissions resulting from the
use of the fuel or additive contained in such fuel, the
effect of such fuel or additive on the emission control
performance of any vehicle or vehicle engine, or the extent
to which such emissions affect the public health or welfare.
Tests under subparagraph (A) shall be conducted in conformity
+j with test procedures and protocols established by the Administrator.
The results of such tests shall not be considered confidential.
XIV
(3) Upon compliance with the provisions of this subsection,
including assurance that the Administrator will receive changes in
the information required, the Administrator shall register such
fuel or fuel additive.
(c) (1) The Administrator may, from time to time on the basis of
information obtained under subsection (b) of this section or
other information available to him, by regulation, control or
prohibit the manufacture, introduction into commerce, offering for
-------
CAA - 18
sale, or sale of any fuel or fuel additive for use in a motor
vehicle or motor vehicle engine (A) if in the judgment of the
Administrator any emission product of such fuel or fuel additive
causes, or contributes, to air pollution which may reasonably be
anticipated to endanger the public health or welfare, or (B) if
emission products of such fuel or fuel additive will impair to a
significant degree the performance of any emission control device
or system which is in general use, or which the Administrator
finds has been developed to a point where in a reasonable time
it would be in general use were such regulation to be
promulgated.
(2) (A) No fuel, classes of fuels, or fuel additive may
be controlled or prohibited by the Administrator pursuant
to clause (A) of paragraph (1) except after consideration of
all relevant medical and scientific evidence available
to him, including consideration of other technologically
or economically feasible means of achieving emission
standards under section 202.
(B) No fuel or fuel additive may be controlled or
prohibited by the Administrator pursuant to clause (B) of
paragraph (1) except after consideration of available
scientific and economic data, including a cost-benefit
analysis comparing emission control devices or systems
which are or will be in general use and require the proposed
control or prohibition with emission control devices or
systems which are or will be in general use and do not
require the proposed control or prohibition. On request
IV of a manufacturer of motor vehicle engines, fuels, or fuel
additives submitted within 10 days of notice of proposed
rulemaking, the Administrator shall hold a public hearing
and publish findings with respect to any matter he is
required to consider under this subparagraph. Such
findings shall be published at the time of promulgation
of final regulations.
(C) No fuel or fuel additive may be prohibited by the
Administrator under paragraph (1) unless he finds, and
publishes such finding, that in his judgment such pro-
hibition will not cause the use of any other fuel or fuel
additive which will produce emissions which will endanger
the public health or welfare to the same or greater degree
than the use of the fuel or fuel additive proposed to be
prohibited.
-------
CM - 19
TITLE III -- GENERAL
ADMINISTRATION
VII SEC. 301.
(a) (1) The Administrator is authorized to prescribe such
regulations as are necessary to carry out his functions under
this Act. The Administrator may delegate to any officer or employee
of the Environmental Protection Agency such of his powers and
duties under this Act, except the making of regulations, as he may
deem necessary or expedient.
GENERAL PROVISIONS RELATING TO ADMINISTRATIVE
PROCEEDINGS AND JUDICIAL REVIEW
SEC. 307.
(a) (1) In connection with any determination under section
110(f) [regional energy emergency] or section 202(b)(5) [auto-
mobile emission standard waivers], or for purposes of obtaining
IX information under section 202(b)(4) [report to Congress —
automobile emissions] or 211(c)(3) [regulation of fuels], the
Administrator may issue subpoenas for the attendance and testimony
of witnesses and the production of relevant papers, books, and
documents, and he may administer oaths. Except for emission data,
upon a showing satisfactory to the Administrator by such owner or
operator that such papers, books, documents, or information or
XIV particular part thereof, if made public, would divulge trade
secrets or secret processes, the Administrator shall consider such
record, report, or information or particular portion thereof
confidential in accordance with the purposes of section 1905 of
title 18 of the United States Code, except that such paper, book,
document, or information may be [disclosed] to other officers,
employees, or authorized representatives of the United States
concerned with carrying out this Act, to persons carrying out the
National Academy of Sciences study and investigation provided for
in section 202(c), or when relevant in any proceeding under this
Act...
II (d) (3) In the case of any rule under this Act, notice of
proposed rulemaking shall be published in the Federal Register,
shall be accompanied by a statement of its basis and purpose and
shall specify the period available for public comment. The
statement of basis and purpose shall include a summary of —
-------
CAA - 20
(A) the factual data on which the proposed rule
is based;
(B) the methodology used in obtaining the data and
in analyzing the data; and
(C) the major legal interpretations and policy con-
siderations underlying the proposed rule.
The statement shall also set forth or summarize and provide a
reference to any pertinent findings, recommendations, and comments
by the Scientific Review Committee established under section 109(d)
and the National Academy of Sciences, and, if the proposal differs
in any important respect from any of these recommendations, an
explanation of the reasons for such differences. All data, infor-
mation, and documents referred to in this paragraph on which the
proposed rule relies shall be included in the docket on the date of
publication of the proposed rule.
POLICY REVIEW
ZI SEC. 309.
(a) The Administrator shall review and comment in writing on the
environmental impact of any: (1) legislation proposed by any Federal
department or agency, (2) newly authorized Federal projects for construction
and any major Federal agency action, and (3) proposed regulations published
by any department or agency of the Federal Government. Such written
comment shall be made public at the conclusion of any such review.
(b) In the event the Administrator determines that any such
legislation, action, or regulation is unsatisfactory from the standpoint
of public health or welfare or environmental quality, he shall publish
his determination and the matter shall be referred to the Council on
Environmental Quality.
AIR QUALITY MONITORING
11 SEC. 319.
V
Not later than August 7, 1978, the Administrator shall promulgate
regulations establishing an air quality monitoring system throughout the
United States which —
-------
CAA - 21
(1) utilizes uniform air quality monitoring criteria and
methodology and measures such air quality according to a uniform
air quality index,
(2) provides for air quality monitoring stations in major
urban areas and other appropriate areas throughout the United
States to provide monitoring such as will supplement (but not
duplicate) air quality monitoring carried out by the States
required under any applicable implementation plan,
(3) provides for daily analysis and reporting of air quality
based upon such uniform air quality index, and
(4) provides for record-keeping with respect to such monitoring
data and for periodic analysis and reporting to the general public
by the Administrator with respect to air quality based upon such
data...
NATIONAL COMMISSION ON AIR QUALITY
IV SEC. 323.
(a) There is established a National Commission on Air Quality
which shall study and report to the Congress on —
(1) available alternatives, including enforcement mechanisms
to protect and enhance the quality of the Nation's air resources so
as to promote the public health and welfare and to achieve the
other purposes of the Act, including achievement and maintenance of
national ambient air quality standards and, in accordance with
paragraph (b)(2) below, the prevention of significant deterioration
of air quality;
(2) the economic, technology, and environmental consequences
of achieving or not achieving the purposes of this Act and programs
authorized by it;...
(4) air pollutants not presently regulated, which pose or may
in the future pose a threat to public health or public welfare and
options available to regulate emissions of such pollutants;
(5) the adequacy of research, development, and demonstrations
being carried out by Federal, State, local, and nongovernmental
entities to protect and enhance air quality; ...
-------
CAA - 22
(8) (A) the special problems of small businesses and
government agencies In obtaining reductions of emissions from
existing sources In order to offset Increases In emissions
from new sources for the purposes of this Act; and
(B) alternative strategies for permitting (without
Impeding the achievement of national ambient air quality
standards as expedltlously as possible) the construction and
modification of facilities In air quality control regions
currently exceeding the national ambient air quality standard
for any pollutant regulated under the Act.
(b) (1) Studies and Investigations conducted pursuant to subsection
(a) shall Include the effects of existing or proposed national
ambient air quality standards on employment, energy, and the
economy (Including State and local) , their relationship to
objective scientific and medical data collected to determine their
validity, as well as other social and environmental effects of
national ambient air quality standards...
(e) The heads of the departments, agencies, and Instrumentalities
of the executive branch of the Federal Government shall cooperate with
the Commission In carrying out the requirements of this section, and
shall furnish to the Commission such Information as the Commission deems
necessary to carry out this section. . .
(g) Reports shall be submitted with regard to all Commission
studies and Investigations, together with any appropriate recommendations,
not later than August 17, 1980. Upon submission of such report or upon
expiration of such three-year period, whichever Is sooner, the Commission
shall cease to exist.
PROVISIONS OF PUBLIC LAW 95-95 WHICH DO NOT AMEND
AND THEREFORE ARE NOT PARTS OF THE CLEAN AIR ACT
(The section numbers below refer to the sections of 95-95 and not the
Clean Air Act.)
UNREGULATED POLLUTANTS
n SEC. 120.
(b) The Administrator of the Environmental Protection Agency shall
conduct a study, In conjunction with other appropriate agencies,
concerning the effect on the public health and welfare of sulfates,
-------
CAA - 2'J
radioactive pollutants, cadmium, arsenic, and polycycllc organic matter
which are present or may reasonably be anticipated to occur in the
ambient air. Such study shall include a through investigation of how
sulfates are formed and how to protect public health and welfare from
the injurious effects, if any, of sulfates, cadmium, arsenic, and
polycycllc organic matter.
INTERAGENCY COOPERATION ON PREVENTION OF ENVIRONMENTAL
CANCER AND HEART AND LUNG DISEASE
HI SEC. 402.
(a) Not later than November 7, 1977, there shall be established a
Task Force on Environmental Cancer and Heart and Lung Disease (here-
inafter referred to as the "Task Force"). The Task Force sliall Include
representatives of the Environmental Protection Agency, the National
Cancer Institute, the National Institute of Occupational Safety and
Health, and the National Institute on Environmental Health Sciences, and
shall be chaired by the Administrator (or hlH delegate).
(b) The Task Force shall —
(1) recommend a comprehensive research program to determine
and quantify the relationship between environmental pollution and
human cancer and heart and lung disease;
(2) recommend comprehensive strategies to reduce or eliminate
the risks of cancer or such other diseases associated with
environmental pollution;
(3) recommend research and such other measures as may be
appropriate to prevent or reduce the incidence of environmentally-
related cancer and heart and lung diseases;
(4) coordinate research by, and stimulate cooperation
between, the Environmental Protection Agency, the Department of
Health, Education and Welfare, and such other agencies as may be
appropriate to prevent environmentally-related cancer and heart and
lung diseases; and
(5) report to Congress, not later than August 7, 1978, and
annually thereafter, on the problems and progress In carrying ou}/
this section.
-------
CAA - 24
STUDIES
II SEC. 403.
(a) Not later than January 7, 1979, the Administrator of the
Environmental Protection Agency, in cooperation with the National
Academy of Sciences, shall study and report to Congress on (1) the
relationship between the size, weight, and chemical composition of
suspended particulate matter (especially with respect to fine part-
iculate matter) and (2) the availability of technology for controlling
such particulate matter.
(b) The Administrator of the Environmental Protection Agency shall
conduct a study and report to the Congress not later than January 1,
1979, on the effects on public health and welfare of odors or odorous
emissions, the sources of such emissions, the technology or other
measures available for control of such emissions and the costs of such
technology or measures, and the costs and benefits of alternative
measures or strategies to abate such emissions. Such reports shall
include an evaluation of whether air quality criteria or national
ambient air quality standards should be published under the Clean Air
Act for odors, and what other strategies or authorities under the Clean
Air Act are available or appropriate for abating such emissions.
(c) (1) Not later than August 7, 1978, the Administrator
of the Environmental Protection Agency shall publish throughout the
United States a list of all known chemical contaminants resulting
from environmental pollution which have been found in human tissue
including blood, urine, breast milk, and all other human tissue.
Such list shall be prepared for the United States and shall
indicate the approximate number of cases, the range of levels
found, and the mean levels found.
(2) Not later than January 7, 1979, the Administrator shall
publish in the same manner an explanation of what is known about
the manner in which the chemicals described in paragraph (1)
entered the environment and thereafter human tissue.
(3) The Administrator, in consultation with National
Institutes of Health, the National Center for Health Statistics,
and the National Center for Health Services Research and Develop-
ment, shall, if feasible, conduct an epidemiological study to
demonstrate the relationship between levels of chemicals in the
environment and in human tissue. Such study shall be made in
appropriate regions or areas of the United States in order to
determine any different results in such regions or areas. The
results of such study shall, as soon as practicable, be reported to
the appropriate committee of the Congress.
-------
CAA - 25
(d) The Administrator of the Environmental Protection Agency
shall conduct a study of air quality in various areas throughout the
country, including the Gulf Coast region. Such study shall include
analysis of liquid and solid aerosols and other fine particulate matter
and the contribution of such substances to visibility and public health
problems in such areas. For the purposes of this study, the Admin-
istrator shall use environmental health experts from the National
Institutes of Health and other outside agencies and organizations.
-------
[33 U.S.C. 466 et. seq. — Last Amended December 1977]
"THE CLEAN WATER ACT"
In the Federal Water Pollution Control Act Congress
assigned numerous specific information development and research
responsibilities to the Administrator. In accordance with
our classification scheme, much of the Act should be assigned
to categories II and III. Because the results of the required
studies represent a significant source of information on
current pollution patterns and pollution control technology,
we have included these sections.
-------
XVII
[33 U.S.C. et seq. — Amended December 1977]
"THE CLEAN WATER ACT"
TITLE I -- RESEARCH AND RELATED PROGRAMS
DECLARATION OF GOALS AND POLICY
SEC. 101.
(a) (6) It is the national policy that a major research
and demonstration effort be made to develop technology necessary to
eliminate the discharge of pollutants into the navigable waters,
waters of the contiguous zone, and the oceans.
(b) .... It is further the policy of the Congress to support and
aid research relating to the prevention, reduction, and elimination of
pollution, and to provide Federal technical services and financial aid
to State and interstate agencies and municipalities in connection with
the prevention, reduction, and elimination of pollution...
(f) It is the national policy that to the maximum extent possible
the procedures utilized for implementing this Act shall encourage the
drastic minimization of paperwork and interagency decision procedures,
and the best use of available manpower and funds, so as to prevent
needless duplication and unnecessary delays at all levels of government.
COMPREHENSIVE PROGRAMS FOR WATER POLLUTION CONTROL
SEC. 102.
(a) .... For the purpose of establishing comprehensive programs for
water pollution control, the Administrator is authorized to make joint
investigations with any Federal, State, interstate and local agencies of
the condition of any waters in any State or States, and of the dis-
charges of any sewage, industrial wastes, or substance which may
adversely affect such waters.
RESEARCH, INVESTIGATIONS, TRAINING AND INFORMATION
H SEC. 104.
Ill
(a) The Administrator shall establish national programs for the
prevention, reduction, and elimination of pollution and as part of such
programs shall —
-------
FWPCA - 2
(1) in cooperation with other Federal, State, and local
agencies, conduct and promote the coordination and acceleration of
research, investigations, experiments, training, demonstrations,
surveys, and studies relating to the causes, effects, extent,
prevention, reduction and elimination of pollution;
(2) encourage, cooperate with, and render technical services
to pollution control agencies and other appropriate public or
private agencies, institutions, and other organizations, and
individuals, including the general public, in the conduct of
activities referred to in paragraph (1) above;
(3) conduct ... public investigations concerning the
pollution of any navigable waters, and report the results;
IV (4) establish advisory committees composed of recognized
experts in various aspects of pollution and representatives of the
public to assist in the examination and evaluation of research
progress and proposals and to avoid duplication of research;
V (5) ... establish, equip, and maintain a water quality
surveillance system for the purpose of monitoring the quality of
the navigable waters, ground waters, the contiguous zone and the
oceans, and the Administrator shall, to the extent practicable,
conduct such surveillance utilizing the resources of the National
Aeronautics and Space Administration, the National Oceanic and
Atmospheric Administration, the Geological Survey, and the Coast
Guard, and shall report on such quality in the report required
under subsection 516(a) below; and
(6) initiate and promote the coordination and acceleration of
research designed to develop the most effective practicable tools
and techniques for measuring the social and economic costs and
benefits of activities which are subject to regulation under this
Act, and shall transmit a report on the results of such research to
the Congress not later than January 1, 1974.
(b) In carrying out the provisions of subsection (a) above,
the Administrator is authorized to —
(1) collect and make available through appropriate means,
the results of the research and other activities referred to in
this section, as well as any other information or recommendations
he has in regards to such research and activities;
(2) cooperate with other Federal departments and agencies,
State water pollution control agencies, interstate agencies, other
public and private agencies, institutions, organizations, industries
involved, and individuals, in the preparation and conduct of such
research and other activities referred to in this section;
-------
FWPCA - 3
(3) make grants to State water pollution control agencies,
interstate agencies, other public or non-profit private agencies,
institutions, organizations, and individuals, for purposes stated
in paragraph (1) of subsection (a) above;
(4) contract with public or private agencies, institutions,
organizations, and individuals, without regard to sections 3648
and 3709 of the Revised Statutes (31 U.S.C 529; 41 U.S.C. 5);...
(6) collect and disseminate ..., basic data on chemical,
physical, and biological effects of varying water quality and other
information pertaining to pollution and the prevention, reduction,
and elimination thereof; and
(7) develop effective and practical processes, methods, and
prototype devices for the prevention, reduction, and elimination of
pollution.
(c) In carrying out the provisions of subsection 104(a) above, the
Administrator shall conduct research on, and survey the results of other
scientific studies on, the harmful effects on the health or welfare of
persons caused by pollutants. In order to avoid duplication of effort,
the Administrator shall, to the extent practicable, conduct such
research in cooperation with and through the facilities of the Secretary
of Health, Education, and Welfare.
(d) In carrying out the provisions of this section the Admin-
istrator shall develop and demonstrate under varied conditions
(including conducting such basic and applied research, studies, and
experiments as may be necessary);...
(2) Improved methods and procedures to identify and measure
the effects of pollutants, including those pollutants created by
new technological developments; and...
(e) The Administrator shall establish, equip, and maintain at
least six laboratory and research facilities..., for the conduct of
research, investigations, experiments, field demonstrations and studies,
and training relating to the prevention, reduction and elimination of
pollution. Insofar as practicable, each such facility shall be located
near institutions of higher learning in which graduate training in such
research might be carried out.
(f) The Administrator shall conduct research and technical
development work, and make studies, with respect to the waters of the
Great Lakes, including an analysis of ..., an evaluation of municipal,
industrial, and vessel waste treatment and disposal practices with
respect to such waters, and a study of alternate means of solving
pollution problems (including additional waste treatment measures) with
respect to such waters...
-------
FWPCA - 4
(h) The Administrator is authorized to enter into contracts with,
or make grants to, public or private agencies and organizations and
individuals for the purpose of developing and demonstrating new or
improved methods for the prevention, removal, reduction, and elimination
of pollution in lakes...
(i) The Administrator, in cooperation with the Coast Guard, shall —
(1) engage in such research, studies, experiments, and demon-
strations as he deems appropriate, relative to the removal of oil
from any waters and to the prevention, control, and elimination of
oil and hazardous substances pollution;
(2) publish from time to time the results of such activities;
and...
In carrying out this subsection, the Administrator may enter into
contracts with, or make grants to, public or private agencies and
organizations and individuals...
(1) (1) The Administrator shall, after consultation with
appropriate agencies and organizations and not later than January
1, 1973, develop and issue to the States the latest scientific
knowledge available indicating the kind and extent of effects on
health and welfare which may be expected from the presence of
pesticides in the water in varying quantities. He shall revise and
add to such information whenever necessary to reflect developing
scientific knowledge.
(2) The President shall, in consultation with appropriate
agencies and organizations conduct studies and investigations of
methods to control the release of pesticides into the environment
which studies shall include examination of the persistency of
pesticides in the water environment and alternatives thereto. The
President shall submit such reports, from time to time to Congress.
(m) (1) The Administrator shall conduct a study of (A) the
generation of used engine, machine, cooling, and similar waste oil,
including quantities generated, the nature and quality of such oil,
present collecting methods and disposal practices, and alternate
uses of such oil; (B) the long-term chronic biological effects of
the disposal of such waste oil; and (C) the potential market for
such oils, including the economic and legal factors relating to the
sale of products made from such oils, the level of subsidy, if any,
needed to encourage the purchase by public and private non-profit
agencies of products from such oil, and the practicability of
Federal procurement, on a priority basis, of products made from
such oil.
-------
FWPCA - 5
(2) The Administrator shall report the preliminary results
of such study to Congress before April 18, 1973, and shall submit
a flinal report to Congress before April 18, 1974.
(1) The Administrator shall, in cooperation with appropriate
^public bodies, private organizations, institutions, and individuals,
conduct, promote, and encourage contributions to, continuing
comprehensive studies of the effects of pollution, including
sedimentation, in the estuaries and estuarine zones of the United
States on fish and wildlife .... and on other beneficial purposes.
Such studies shall also consider the effect of demographic trends,
the exploitation of mineral resources and fossil fuels, land and
industrial development, navigation, flood and erosion control, and
other uses of estuaries and estuarine zones upon the pollution of
the waters therein.
(2) In conducting such studies, the Administrator shall
assemble, coordinate, and organize all existing pertinent infor-
mation on the Nation's estuaries and estuarine zones; carry out a
program of investigations and surveys to supplement existing
information in representative estuaries and estuarine zones; and
identify the problems and areas where further research and study
are required.
(3) The Administrator shall submit to Congress, from time to
time, reports of the studies authorized by this subsection but at
least one such report during any six-year period. Copies of each
report shall be made available to all interested parties, public
and private. . .
(p) In carrying out the provisions of subsection (a) above, the
Administrator shall, in cooperation with the Secretary of Agriculture,
other Federal agencies, and the States, carry out a comprehensive study
and research program to determine new and improved methods of preventing,
reducing, and eliminating pollution from agriculture, including the
legal, economic, and other implications of the use of such methods...
(r) The Administrator is authorized to make grants to colleges and
universities to conduct basic research into the structure and function
of fresh water aquatic ecosystems, and to improve understanding of the
ecological characteristics necessary to the maintenance of the chemical,
physical, and biological integrity of freshwater aquatic ecosystems.
(s) The Administrator is authorized to make grants to one or more
institutions of higher education [regionally located and to be designated
as "River Study Centers"] for the purpose of conducting and reporting on
interdisciplinary studies on the nature of river systems, including
hydrology, biology, ecology, economics, the relationship between river
uses and land uses, and the effects of development within river basins
on river systems and on the value of water resources and water related
activities. No such grant in any fiscal year shall exceed $1,000,000...
-------
FWPCA - 6
GRANTS FOR RESEARCH AND DEVELOPMENT
II SEC. 105...
Ill
(c) In order to carry out the purposes of section 301 [effluent
limitations], the Administrator is authorized to (1) conduct in the
Environmental Protection Agency, (2) make grants to persons, and (3)
enter into contracts with persons, for research and demonstration
projects for prevention of pollution of any waters by industry
including, but not limited to, the prevention, reduction, and elim-
ination of the discharge of pollutants. No grant shall be made for any
project under this subsection unless the Administrator determines that
such project will develop or demonstrate a new or improved method of
treating industrial wastes or otherwise prevent pollution by industry,
which method shall have industry-wide application.
(d) In carrying out the provisions of this section, the Admin-
istrator shall conduct, on a priority basis, an accelerated effort to
develop, refine, and achieve practical application of:
(1) waste management methods applicable to point and
non-point sources of pollutants to eliminate the discharge of
pollutants, including, but not limited to, elimination of runoff
of pollutants and the effects of pollutants from in-place or
accumulated sources;
(2) advanced waste treatment methods applicable to point
and non-point sources, including in-place or accumulated sources
of pollutants, and methods for reclaiming and recycling water and
confining pollutants so they will not migrate to cause water or
other environmental pollution; and
(3) improved methods and procedures to identify and measure
the effects of pollutants on the chemical, physical, and biological
integrity of water, including those pollutants created by new
technological developments.
(e) (1) The Administrator is authorized to (A) make, in con-
sultation with the Secretary of Agriculture, grants to persons for
research and demonstration projects with respect to new and
improved methods of preventing, reducing, and eliminating pollution
from agriculture, and (B) disseminate, in cooperation with the
Secretary of Agriculture, such information obtained under this
subsection, section 104(p) above and section 304 [information and
guidelines] as will encourage and enable the adoption of such
methods in the agricultural industry ...
-------
FWPCA - 7
IN-PLACE TOXIC POLLUTANTS
II SEC. 115.
Ill
The Administrator is directed to identify the location of in-place
pollutants with emphasis on toxic pollutants in harbors and navigable
waterways and is authorized, acting through the Secretary of the Army,
to make contracts for the removal and appropriate disposal of such
materials from critical port and harbor areas...
TITLE II — GRANTS FOR CONSTRUCTION OF
TREATMENT WORKS
AREAWIDE WASTE TREATMENT MANAGEMENT
SEC. 208...
(b) (2) Any areawide waste treatment management plan shall
include, but not be limited to ...
XVII (K) a process to control the disposal of pollutants
on land or in subsurface excavations within such area to
protect ground and surface water quality.
TITLE III — STANDARDS AND ENFORCEMENT
EFFLUENT LIMITATIONS
II SEC. 301...
(a) Except in compliance with this section and sections 302, 306,
307, 318, 402 and 404, the discharge of any pollutant shall be unlawful.
(b) [The Administrator shall establish and enforce the following
effluent limitations based on availability of technology]...
(c) [modifications of requirements of effluent limitations]
-------
FWPCA - 8
(d) Any effluent limitation required by paragraph (b)(2)
above, shall be reviewed at least every five years and, if appropriate,
revised pursuant to the procedure established under such paragraph...
(g)-(l) [modifications of requirements of effluent limitations]
WATER QUALITY STANDARDS AND IMPLEMENTATION PLANS
SEC. 303...
IV (c) (1) The Governor of a State or the State water pollution
control agency shall at least once each three years hold public
hearings for the purpose of reviewing, modifying and adopting
applicable water quality standards. Results of such review shall
be made available to the Administrator.
(2) Whenever the State revises or adopts a new standard, it
shall be submitted to the Administrator...
(3) If the Administrator, within sixty days, determines that
a revised or new standard meets the requirements of this Act,
it shall thereafter be the water quality standard for the applicable
waters of that State. If the Administrator determines that any
such standard is not consistent with this Act, he shall, within 90
days, notify the State and specify the changes to meet such
requirement. If such changes are not adopted by the State, the
Administrator shall promulgate such standard pursuant to paragraph
(A) below.
(A) The Administrator shall promptly prepare and publish
proposed regulations setting forth a revised or new water quality
standard for the navigable waters involved —
(A) if a revised or new water quality standard submitted
by such State for such waters is determined not to be
consistent with this Act, or
(B) in any case where the Administrator determines that
a revised or new standard is necessary to meet the require-
ments of this Act...
II (d) (1) (A) Each State shall identify those waters within its
boundaries for which the effluent limitations required by
subparagraph 301(b)(l)(A) and subparagraph 301(b)(l)(B) are
not stringent enough to implement any water quality standard
-------
FWPCA - 9
applicable to such waters. The State shall establish a
priority ranking for such waters, taking into account the
severity of the pollution and the uses to be made of such
waters...
INFORMATION AND GUIDELINES
SEC. 304...
(a) (1) The Administrator shall develop and publish, within
one year, and periodically revise, criteria for water quality
accurately reflecting the latest scientific knowledge (A) on the
kind and extent of all identifiable effects on health and welfare
including, but not limited to, plankton, fish, shellfish, wildlife,
plant life, shorelines, beaches, esthetics, and recreation which
may be expected from the presence of pollutants in any body of
water, including ground water; (B) on the concentration and
dispersal of pollutants, or their byproducts, through biological,
physical, and chemical processes; and (C) on the effects of
pollutants on biological community diversity, productivity, and
stability, including information on the factors affecting rates of
eutrophication and rates of organic and inorganic sedimentation for
varying types of receiving waters.
(2) The Administrator shall develop and publish, within one
year, and periodically revise, information (A) on the factors
necessary to restore and maintain the chemical, physical, and
biological integrity of all navigable waters, ground waters, waters
of the contiguous zone, and the oceans; (B) on the factors necessary
for the protection and propagation of shellfish, fish, and wildlife
for classes and categories of receiving waters and to allow
recreational activities in and on the water; (C) on the measurement
and classification of water quality; and (D) for the purpose of
section 303 [water quality standards and implementation plans]
on and the identification of pollutants suitable for maximum daily
load measurement correlated with the achievement of water quality
obj ectives.
(3) Such criteria and information and revisions shall be
issued to the States, published in the Federal Register and
otherwise made available to the public.
(b) For the purpose of adopting or revising effluent limitations
under this Act the Administrator shall publish and review at least
annually, regulations, providing guidelines for effluent limitations.
Such regulations shall —
-------
FWPCA - 10
(1) (A) identify, in terms of amounts of constituents
and chemical, physical, and biological characteristics of
pollutants, the degree of effluent reduction attainable
through the application of the best practicable control
technology currently available for classes and categories of
point sources (other than publicly owned treatment works); and
(B) specify factors to be considered when determining
the control measures and practices to be applicable to point
sources (other than publicly owned treatment works) within
such categories or classes. Factors relating to the assess-
ment of best practicable control technology currently
available to comply with subsection 301(b)(l) [1977
requirements] shall include consideration of the total cost of
application of technology in relation to the effluent
reduction benefits to be achieved and shall also take into
account the age of equipment and facilities involved, the
process employed, the engineering aspects of the application
of various types of control techniques, process changes, non-
water quality environmental impact (including energy require-
ments) , and such other factors as the Administrator deems
appropriate;
(2) (A) identify, in terms of amounts of constituents and
chemical, physical, and biological characteristics of
pollutants, the degree of effluent reduction attainable
through the application of the best control measures and
practices achievable including treatment techniques, process
and procedure innovations, operating methods, and other
alternatives for classes and categories of point sources
(other than publicly owned treatment works); and
(B) specify factors to be considered when determining
the best measures and practices available to comply with
subsection 301(b)(2) [1983 - 1987 requirements] to be applicable
to any point source (other than publicly owned treatment
works) within such categories [or] classes. Factors relating
to the assessment of best available technology shall take into
account the age of equipment and facilities involved, the
process employed, the engineering aspects of the application
of various types of control techniques, process changes, the
cost of achieving such effluent reduction, non-water quality
environmental impact (including energy requirements), and such
other factors as the Administrator deems appropriate;
(3) identify control measures and practices available to
eliminate the discharge of pollutants from categories and classes
of point sources, taking into account the cost of achieving such
elimination of the discharge of pollutants; and ...
-------
FWPCA - 11
(c) The Administrator shall issue to the States and appropriate
water pollution control agencies [before July 1973] (and from time to
time thereafter) information on the processes, procedures, or operating
methods which result in the elimination or reduction of the discharge of
pollutants necessary to achieve standards of performance under section
306 of this Act. Such information shall include technical and other
data, including costs, as are available on alternative methods of
elimination or reduction of the discharge of pollutants. Such infor-
mation, and revisions shall be published in the Federal Register and
otherwise made available to the public...
(e) The Administrator may publish regulations for any specific
pollutant which he is charged with a duty to regulate as a toxic or
hazardous pollutant under section 307(a)(1) [toxic and pretreatment
effluent standards] or 311 [oil and hazardous substance liability]
of this Act, to control plant site runoff, spillage or leaks, sludge or
waste disposal, and drainage from raw material storage which the
Administrator determines are associated with or ancillary to the
industrial manufacturing or treatment process within such class or
category of point sources and may contribute significant amounts of such
pollutants to navigable waters. Any applicable controls established
under this subsection shall be included as a requirement for the
purposes of section 301, 302, 306, 307, or 403, as the case may be, in
any permit issued to a point source pursuant to section 402 of this Act
[national pollutant discharge elimination],
(f) The Administrator shall issue, to appropriate Federal agencies,
the States, water pollution control agencies, and agencies designated
under section 208, before October 1973 and periodically thereafter,
information including (1) guidelines for identifying and evaluating the
nature and extent of nonpoint sources of pollutants, and (2) processes,
procedures, and methods to control pollution resulting from
(A) agricultural and silvicultural activities, including
runoff from fields and crop and forest lands;
(B) mining activities, including runoff and siltation
from new, currently operating, and abandoned surface and
underground mines;...
(D) the disposal of pollutants in wells or in subsurface
excavations; ...
•
Such information and revisions shall be published in the Federal
Register and otherwise made available to the public.
(g) (1) For the purpose of assisting States in carrying out
programs under section 402 [national pollutant discharge
elimination], the Administrator shall publish and review or revise
-------
FWPCA - 12
at let t annually, guidelines for pretreatment of pollutants which
he determines are not susceptible to treatment by publicly owned
treatment works. Guidelines under this subsection shall be
established to control and prevent the discharge into the navigable
waters, the contiguous zone, or the ocean (either directly or
through publicly owned treatment works) of any pollutant which
interferes with, passes through, or otherwise is incompatible with
such works...
(h) The Administrator shall promulgate guidelines establishing
test procedures for the analysis of pollutants that shall include the
factors which must be provided in any certification pursuant to section
401 [certification] or permit application pursuant to section 402
[national pollutant discharge elimination].
(i) The Administrator shall (1) promulgate guidelines for the
purpose of establishing uniform application forms and other minimum
requirements for the acquisition of information from owners and
operators of point sources of discharge subject to any State program
under section 402 of this Act, and (2) ... promulgate guidelines
establishing the minimum procedural and other elements of any State
program under section 402 of this Act which shall include:
(A) monitoring requirements;
(B) reporting requirements (including procedures
to make information available to the public);
(C) enforcement provisions; and ....
(j) The Administrator shall issue information biennially on methods,
procedures, and processes to restore and enhance the quality of the
Nation's publicly owned freshwater lakes.
(k) (1) The Administrator shall enter into agreements with
the Secretary of Agriculture, the Secretary of the Army, and
the Secretary of the Interior, and the heads of such other
departments, agencies, and instrumentalities of the United
States as he determines, to provide for maximum utilization of
other Federal laws and programs for the purpose of achieving
and maintaining water quality through appropriate implementation
of plans approved under section 208 [areawide waste treatment
management]...
WATER QUALITY INVENTORY
XII SEC. 305...
II
(b) (1) Each State shall prepare and submit to the Administrator
by April 1, 1975, and shall bring up to date by April 1, 1976,
and biennially thereafter, a report which shall include —
-------
FWPCA - 13
(A) a description of the water quality of all
navigable waters in such State during the preceding year,
with appropriate supplemental descriptions as shall be
required to take into account seasonal, tidal, and other
variations, correlated with the quality of water required
by the objective of this Act and the water quality
described in subparagraph (B) of this paragraph;
(B) an analysis of the extent to which all navigable
waters of such State provide for the protection and
propagation of a balanced population of shellfish, fish,
and wildlife, and allow recreational activities in and on
the water;...
(D) an estimate of (i) the environmental impact,
(ii) the economic and social costs necessary to achieve
the objective of this Act in such State, (iii) the economic
and social benefits of such achievement, and (iv) an
estimate of the date of such achievement; and
(E) a description of the nature and extent of
non-point sources of pollutants, and recommendations as
to the programs which must be undertaken to control each
category of such sources, including an estimate of the costs
of implementing such programs.
(2) The Administrator shall transmit such State reports,
together with an analysis of them, to Congress on or before
October 1, 1975, and October 1, 1976, and biennially thereafter.
NATIONAL STANDARDS OF PERFORMANCE
•J.-J- SEC. 306.
(a) For purposes of this section:
(1) "Standard of performance" means a standard for the
control of the discharge of pollutants which reflects the greatest
degree of effluent reduction which the Administrator determines to
be achievable through application of the best available demon-
strated control technology, processes, operating methods, or other
alternatives, including, where practicable, a standard permitting
no discharge of pollutants.
(2) "New source" means any source, the construction of which
is commenced after the publication of proposed regulations
prescribing a standard of performance under section which will be
applicable to such source, if such standard is thereafter pro-
mulgated in accordance with this section.
-------
FWPCA - 14
(3) "Source" means any building, structure facility,
XVI or installation from which pollutants are or may be discharged.
(b) (1) (A) The Administrator shall publish (and from time
to time thereafter shall revise) a list of categories of
sources, which shall, at the minimum, include:
pulp and paper mills; ...
textile mills; ...
electroplating;
organic chemicals manufacturing;
inorganic chemicals manufacturing;
plastic and synthetic materials manufacturing;
soap and detergent manufacturing;
fertilizer manufacturing;
petroleum refining; ...
nonferrous metals manufacturing;
phosphate manufacturing; ...
ferroalloy manufacturing;
leather tanning and finishing;
glass and asbestos manufacturing;
rubber processing; and
timber products processing.
(B) As soon as practicable, but in no case more than
one year after a category of sources is included in the list,
the Administrator shall propose and publish regulations
establishing Federal standards of performance for new sources
within such category. The Administrator shall afford interested
persons an opportunity for written comment on such proposed
regulations. After considering such comments, he shall
promulgate (within one hundred and twenty days after proposal)
final standards. The Administrator shall, as technology and
alternatives change, revise such standards following the
procedure required by this subsection for initial promulgation.
In establishing or revising Federal standards of performance
for new sources under this section, the Administrator shall
take into consideration the cost of achieving such effluent
reduction, and any non-water quality environmental impact
and energy requirements.
(2) The Administrator may distinguish among classes, types,
and sizes within categories of new sources for the purpose of
establishing such standards and shall consider the type of
process employed (including whether batch or continuous).
-------
FWPCA - 15
TOXIC AND PRETREATMENT EFFLUENT STANDARDS
II SEC. 307.
(a) (1) On and after the date of enactment of the Clean Water
Act of 1977, the list of toxic pollutants or combinations of
pollutants subject to this Act shall consist of those toxic
pollutants listed below:
Acenaphthene
Acrolein
Acrylonitrile
Aldrin/Dieldrin
Antimony and compounds
Arsenic and compounds
Asbestos
Benzene
Benzidine
Beryllium and compounds
Cadmium and compounds
Carbon tetrachloride
Chlordane (technical mixture and metabolites)
Chlorinated benzenes (other than dichlorobenzenes)
Chlorinated ethanes (including 1,2-dichloroethane,
1,1,1-trichloroethane, and hexachloroethane)
Chloroalkyl ethers (chloromethyl, chloroethyl, and
mixed ethers)
Chlorinated naphthalene
Chlorinated phenols (other than those listed elsewhere;
includes trichlorophenols and chlorinated cresols)
Chloroform
2-chlorophenol
Chromium and compounds
Copper and compounds
Cyanides
DDT and metabolites
Dichlorobenzenes (1,2-, 1,3-, and 1,4-dichlorobenzenes)
Dichlorobenzidine
Dichloroethylenes (1,1- and 1,2-dichloroethylene)
2,4-dichlorophenol
Dichloropropane and dichloropropene
2,4-dimethylphenol
Dinitrotoluene
Diphenylhydrazine
Endosulfan and metabolites
Endrin and metabolites
Ethylbenzene
Flouranthene
Haloethers (other than those listed elsewhere;
includes chlorophenylphenyl ethers, bromo-
phenylphenyl ether, bis(dichloroisopropyl)
ether, bis-(chloroethoxy) methane and
polychlorinated diphenyl ethers)
-------
FWPCA - 16
Halomethanes (other than those listed elsewhere;
includes methylene chloride, methylchloride,
methylbromide, bromoform, dichlorobromomethane,
trichlorofluoromethane, dichlorodifluoromethane)
Heptachlor and metabolites
Hexachlorobutadiene
Hexachlorocyclohexane (all isomers)
Hexachlorocyclopentadiene
Isophorone
Lead and compounds
Mercury and compounds
Naphthalene
Nickel and compounds
Nitrobenzene
Nitrophenols (including 2,4-dinitrophenol,
dinitrocresol)
Nitrosamines
Pentachlorophenol
Phenol
Phthalate esters
Polynuclear aromatic hydrocarbons (including
benzanthracenes, benzopyrenes, benzofluoranthene,
chrysenes, dibenzanthracenes, and indenopyrenes)
Selenium and compounds
Silver and compounds
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)
Tetrachloroethylene
Thallium and compounds
Toluene
Toxaphene
Trichloroethylene
Vinyl chloride
Zinc and compounds
The Administrator may revise the list and is authorized to add to
or remove any pollutant from the list. In publishing any revised
list, the Administrator shall take into account the toxicity of the
pollutant, its persistence, degradability the usual or potential
presence of the affected organisms in any waters, the importance of
the affected organisms, and the nature and extent of the effect of
the toxic pollutant on such organisms.
(2) Each toxic pollutant listed in accordance with paragraph
(1) above shall be subject to effluent limitations achievable by
application of the best available technology economically achievable
for the applicable category or class of point sources established
in accordance with sections 301(b)(2)(A) [effluent limitations;
1983-1987 requirements] and 304(b)(2) [information and guidelines].
[For each toxic pollutant the Administrator includes on the list, he
shall establish effluent limitations as provided below. In his
discretion, the Administrator may, in addition, propose an effluent
-------
FWPCA - 17
standard for any toxic pollutant on the list, which standard shall
supersede any effluent limitations for those categories or classes
of sources for which the standards are more stringent than the
limitations.] Such published effluent standard (or prohibition)
shall take into account the toxicity of the pollutant, its
persistence, degradability, the usual or potential presence of the
affected organisms in any waters, the importance of the affected
organisms and the nature and extent of the effect of the toxic
pollutant on such organisms, and the extent to which effective
control is being or may be achieved under other regulatory authority.
The Administrator shall allow a period of not less than sixty days
following publication of any such proposed effluent standard (or
prohibition) for written comment. In addition, if any interested
person requests, the Administrator shall hold a public hearing.
Such a public hearing shall provide an opportunity for oral and
written presentations, such cross-examination as the Administrator
determines is appropriate and the transcription of a verbatim
record which shall be available to the public. After consideration
of such comments and any information and material presented at any
public hearing held on such proposed standard or prohibition, the
Administrator shall promulgate final standards (or prohibition).
Such promulgation shall be within two hundred and seventy days
after proposal. Effluent limitations shall be established in
accordance with sections 201(b)(2)(A) and 304(b)(2) for every toxic
pollutant listed above by the Committee on Public Works and
Transportation of the House as soon as practicable after the date
of enactment of the Clean Water Act 1977, but no later than July 1,
1980. Effluent limitations or effluent standards (or prohibitions)
shall be established for every other toxic pollutant listed under
paragraph (1) of this subsection as soon as practicable after it is
listed.
(3) Each such effluent standard (or prohibition) shall be
reviewed and, if appropriate, revised at least every three years.
(4) Any effluent standard promulgated under this section
shall be at that level which the Administrator determines provides
an ample margin of safety...
(7) Prior to publishing any regulations pursuant to this
section the Administrator shall, to the maximum extent practicable
within the time provided, consult with appropriate advisory
committees, States, independent experts, and Federal departments
and agencies.
(b) (1) The Administrator shall before April 18, 1973, and from
time to time thereafter, publish proposed regulations establishing
pretreatment standards for introduction of pollutants into publicly
owned treatment works for those pollutants which are determined not
to be susceptible to treatment by such treatment works or which
-------
FWPCA - 18
would interfere with the operation of such treatment works. Pre-
treatment standards under this subsection... shall be established
to prevent the discharge of any pollutant through treatment works
which are publicly owned, which pollutant interferes with, passes
through, or otherwise is incompatible with such works....
(c) In order to insure that any source introducing pollutants into
a publicly owned treatment works (which source would be a new source and
subject to section 306 if it were to discharge such pollutants) will not
cause a violation of the effluent limitations established for any such
treatment works, the Administrator shall promulgate pretreatment
standards for the category of such sources simultaneously with the
promulgation of standards of performance under section 306 for the
equivalent category of new sources. The pretreatment standards shall
prevent the discharge into such treatment works, of any pollutant which
may interfere with, pass through, or otherwise be incompatible with such
works...
INSPECTIONS, MONITORING, AND ENTRY
SEC. 308.
(a) Whenever required to carry out the objective of this Act,
including but not limited to (1) developing or assisting in the
development of any effluent limitation, or other limitation, prohibition,
or effluent standard, pretreatment standard, or standard of performance
under this Act; (2) determining whether any person is in violation of
any such effluent limitation, or other limitation, prohibition or
effluent standard, pretreatment standard, or standard of performance;
(3) any requirement established under this section; or (4) carrying out
sections 305, 311, 402, 404 (relating to State permit programs), and 504
(emergency powers) —
(A) the Administrator shall require the owner or
operator of any point source to (i) establish and maintain
such records, (ii) make such reports, (iii) install, use, and
maintain such monitoring equipment or methods, (iv) sample
V such effluents (in accordance with such methods, at such
locations, at such intervals, and in such manner as the
XIII Administrator shall prescribe), and (v) provide such infor-
mation as he may reasonably require; and
(B) the Administrator or his authorized representative,
upon presentation of his credentials —
(i) shall have a right of entry to, upon, or
through any premises in which an effluent source is
located or in which any records required to be maintained
under clause (A) above are located, and
-------
FWPCA - 19
(ii) may at reasonable times have access to and
copy any records, inspect any monitoring equipment or
method required under clause (A), and sample any
effluents which the owner or operator of such source is
required to sample under such clause.
XIV 0>) Any records, reports, or information obtained under this
section (1) shall, in the case of effluent data, be related to any
applicable effluent limitations, toxic, pretreatment, or new source
performance standards, and (2) shall be available to the public, except
that upon a showing satisfactory to the Administrator by any person
that records, reports, or information, or particular part thereof (other
than effluent data), to which the Administrator has access under this
section, if made public would divulge methods or processes entitled to
protection as trade secrets of such person, the Administrator shall
consider such record, report, or information, or particular portion
thereof confidential in accordance with the purposes of section 1905 of
title 18 of the United States Code, except that such record, report, or
information may be disclosed to other officers, employees, or authorized
representatives of the United States concerned with carrying out this
Act or when relevant in any proceeding under this Act.
XVII (c) Each State may develop and submit to the Administrator
procedures under State law for inspection, monitoring, and entry with
respect to point sources located in such State. If the Administrator
finds that the procedures and the law of any State relating to
inspection, monitoring, and entry are applicable to at least the same
extent as those required by this section, such State is authorized to
apply and enforce its procedures for inspection, monitoring, and entry
with respect to point sources located in such State (except with respect
to point sources owned or operated by the United States).
OIL AND HAZARDOUS SUBSTANCE LIABILITY
SEC. 311.
(a) For the purpose of this section:
XVI
(1) "Oil" means oil of any kind or in any form, including,
but not limited to, petroleum, fuel oil, sludge, oil refuse,
and oil mixed with wastes other than dredged spoil; ...
(14) "Hazardous substance" means any substance designated
pursuant to subsection (b)(2) below; ...
-------
FWPCA - 20
II (b) (1) The Congress declares that it is the policy of the United
States that there should be no discharges of oil or hazardous
substances into the navigable waters of the United States,
adjoining shorelines, or into or upon the waters of the contiguous
zone, or in connection with activities under the Outer Continental
Shelf Lands Act or the Deepwater Port Act of 1974, or which may
affect natural resources belonging to or under the exclusive
management authority of the United States.
XI (2) (A) The Administrator shall develop, promulgate and
revise as may be appropriate, regulations designating as
hazardous substances, other than oil, such elements and
compounds which, when discharged in any quantity into or upon
the navigable waters of the United States or adjoining
shorelines or the waters of the contiguous zone... present an
imminent and substantial danger to the public health or
welfare, including, but not limited to, fish, shellfish,
wildlife, shorelines, and beaches.
(B) (i) The Administrator shall include in any
designation under subparagraph (A) of this subsection
a determination whether any such designated hazardous
substance can actually be removed...
(3) The discharge of oil or hazardous substances into or upon
the navigable waters of the United States, adjoining shorelines, or
into or upon the waters of the contiguous zone ... in harmful
quantities as determined by the President under paragraph (4) below
is prohibited except ...
(4) The President shall by regulation determine for the
purposes of this section, those quantities of oil and any hazardous
substance the discharge of which, at such times, locations, cir-
cumstances, and conditions, will be harmful to the public health or
welfare of the United States, including but not limited to, fish,
shellfish, wildlife, public and private property, shorelines,
and beaches.
(5) Any person in charge of a vessel or of an onshore
facility or an offshore facility shall, as soon as he has knowledge
of any prohibited discharge of oil or a hazardous substance,
immediately notify the appropriate agency of the United States
Government of such discharge. Any such person who fails to
immediately notify such agency of such discharge shall, upon
conviction, be fined not more than $10,000, or imprisoned for not
more than one year, or both. Notification received pursuant to
this paragraph or information obtained by the exploitation of such
notification shall not be used against any such person in any
criminal case, except a prosecution for perjury or for giving a
false statement...
-------
FWPCA - 21
(c) (2) ... the President shall prepare and publish a National
Contingency Plan for removal of oil and hazardous substances which
shall provide for efficient, coordinated, and effective action to
minimize damage from oil and hazardous substance discharges,
Including containment, dispersal, and removal of oil and hazardous
substances, and^shall include, but not be limited to — ...
(D) a system of surveillance and notice designed to
insure earliest possible notice of discharges of oil and
hazardous substances and imminent threats of such discharges
to the appropriate State and Federal agencies;...
(m) Anyone authorized by the President to enforce the
provisions of this section may, except as to public vessels, (A) board
and inspect any vessel upon the navigable waters of the United States or
the waters of the contiguous zone,... and (C) execute any warrant or
other process issued by an officer or court of competent jurisdiction.
TITLE IV — PERMITS AND LICENSES
CERTIFICATION
SEC. 401.
X (a) (1) Any applicant for a Federal license or permit to conduct
any activity including the construction or operation of facilities,
which may result in any discharge into the navigable waters, shall
provide the licensing or permitting agency a certification from the
State in which the discharge originates or will originate, (or, if
appropriate, from the interstate water pollution control agency-
having jurisdiction over the navigable waters at the point where
the discharge originates or will originate) that any such discharge
will comply with the applicable provisions of section 301 [effluent
IV limitations] , 302, 303 [water quality standards and implementation
plans], and 307 [toxic and pretreatment effluent standards]. In the
case of any activity for which there is not an applicable effluent
limitation or standard, the State shall so certify. Such State or
interstate agency shall establish procedures for public notice and
hearings in the case of applications for certification. No license
or permit shall be granted until the certification required by this
section has been obtained or has been waived. No license or permit
shall be granted if certification has been denied by the State,
interstate agency, or the Administrator.
-------
FWPCA - 22
(2) Upon receipt of an application and certification the
licensing or permitting agency shall immediately notify the
Administrator. Whenever such a discharge may affect, as determined
by the Administrator, the quality of the waters of any other State,
the Administrator shall notify such other State, the licensing or
permitting agency, and the applicant within 30 days. If, such
other State determines that the discharge will affect the
quality of its waters so as to violate any water quality require-
ment in such State, and within sixty days notifies the Administrator
and the licensing or permitting agency in writing of its objection
to the issuance of such license or permit and requests a public
hearing on such objection, the licensing or permitting agency shall
hold such a hearing. The Administrator shall at such hearing
submit his evaluation and recommendations with respect to any such
IV objection to the licensing or permitting agency. Such agency,
based upon the recommendations of such State, the Administrator,
and upon any additional evidence, if any, shall condition such
license or permit in such manner as may be necessary to insure
compliance with applicable water quality requirements. If the
imposition of conditions cannot insure such compliance such agency
shall not issue such license or permit...
II (b) ... The Administrator shall, upbn the request of any Federal
department or agency, or State, or interstate agency, or applicant,
provide, for the purpose of this section, any relevant information on
applicable effluent limitations, or other limitations, standards, regul-
ations, or requirements, or water quality criteria, and shall, when
requested by any such department, or agency, or State, or interstate
agency, or applicant, comment on any methods to comply with such
limitations, standards, regulations, requirements, or criteria...
(d) Any certification provided under this section shall set forth
v any effluent limitations and other limitations and other monitoring
requirements necessary to assure that any applicant for a Federal
license or permit will comply with any applicable effluent limitations
and other limitations, under section 301 or 302, standard of performance
under section 306, or prohibition, effluent standard, or pretreatment
standard under section 307, and with any other appropriate requirement
of State law set forth in such certification, and shall become a
condition on any Federal license or permit subject to the provisions of
this section.
NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM
X SEC. 402.
(a) (1) Except as provided in sections 318 and 404 of this
Act, the Administrator may, after opportunity for public hearing,
-------
FWPCA - 23
issue a permit for the discharge of any pollutant, or combin-
ation of pollutants, notwithstanding section 301(a), upon condition
that such discharge will meet either all applicable requirements
under sections 301, 302, 306, 307, 308, and 403 of this Act, or
such conditions as the Administrator determines are necessary to
carry out the provisions of this Act.
(2) The Administrator shall prescribe conditions for such
VII permits to assure compliance with the requirements of paragraph (1)
above, including conditions on data and information collection,
reporting and such other requirements as he deems appropriate.
(3) The permit program of the Administrator under paragraph
(1) above, and permits issued thereunder, shall be subject to the
same terms, conditions, and requirements as apply to a State permit
program...
XVII (b) At any time after the promulgation of the guidelines
for State programs (required by subsection (h)(2) of section 304), the
Governor of each State desiring to administer its own permit program may
submit a full and complete description of the program it proposes. The
Administrator shall approve each such submitted program unless he
determines that adequate legal authority does not exist:
(1) To issue permits which —
(A) apply, and insure compliance with, any applicable
requirements of sections 301, 302, 306, 307, and 402;
(B) are for fixed terms not exceeding five years; ...
(D) control the disposal of pollutants into wells;
(2) (A) To issue permits which apply, and insure compliance
with, all applicable requirements of section 308 (inspections,
monitoring and entry), or
(B) To inspect, monitor, enter, and require reports to
at least the same extent as required in section 308 of
this Act; ...
(4) To insure that the Administrator receives notice and
a copy of each application for a permit;...
(8) To insure that any permit for a publicly owned treatment
works includes conditions to require the identification of
pollutants introduced by any significant source subject to
pretreatment standards and a program to assure compliance with
XI such pretreatment standards. In addition, adequate notice shall
be required (to the permitting agency) of (A) new introductions
of pollutants from any source which would be a "new" source if
it were discharging pollutants, (B) new introductions of pollutants
into such works from a source which would be subject to section 301
-------
FWPCA - 24
if it were discharging such pollutants, or (C) a substantial change
in volume or character of pollutants, being introduced into such
works. Such notice shall include information on the quality and
quantity of effluent to be introduced and any anticipated impact
of such change on the quantity or quality of effluent to be
discharged from such publicly owned treatment works; and
(9) To insure that any industrial user of any publicly owned
treatment works will comply with sections 204 (b) [User Charges
by Treatment Works], 307 [Toxic and Pretreatment Effluent
Standards], and 308 [Inspections, Monitoring and Entry]...
XI (d) (1) Each State shall transmit to the Administrator a copy
of each permit application received and provide notice to the
Administrator of every action related to the consideration of such
permit application, including each permit proposed to be issued.
(2) No permit shall issue (A) if the Administrator objects
in writing, within ninety days, to the issuance of such permit, or
(B) if the Administrator within ninety days of the date of trans-
mittal of the proposed permit by the State objects in writing to
the'issuance of such permit as being outside the guidelines and
requirements of this Act. Whenever the Administrator objects to
the issuance of a permit under this paragraph, such written
objection shall contain a statement of the reasons for such
objection and the effluent limitations and conditions which such
permit would include if it were issued by the Administrator...
(j) A copy of each permit application and each permit
issued under this section shall be available to the public. Such permit
application or permit, or portion thereof, shall be available on request
for the purpose of reproduction.
OCEAN DISCHARGE CRITERIA
II SEC. 403.
X (a) No permit under section 402 [National Pollutant Discharge
Elimination System] of this Act for a discharge into the territorial
sea, the waters of the contiguous zone, or the oceans shall be issued,
after promulgation of guidelines established under subsection (c) below
except in compliance with such guidelines.
(b) The requirements of subsection 402(d) may not be waived in the
case of permits for discharges into the territorial sea.
-------
FWPCA - 25
(c) (1) The Administrator shall, by April 1973 (and from time
to time thereafter), promulgate guidelines for determining the
degradation of the waters of the territorial seas, the contiguous
zone, and the oceans, which shall include:
(A) the effect of disposal of pollutants on human health
or welfare including but not limited to plankton, fish,
shellfish, wildlife, shorelines, and beaches;
(B) the effect of disposal pollutants on marine life
including the transfer, concentration, and dispersal of
pollutants or their byproducts through biological, physical,
and chemical processes; changes in marine ecosystem diversity,
productivity, and stability; and species and community
population changes;
(C) the effect of disposal of pollutants on esthetic,
recreation, and economic values;
(D) the persistence and permanence of the efffects of
disposal of pollutants;
(E) the effect of the disposal at varying rates, of
particular volumes and concentrations of pollutants;
(F) other possible locations and methods of disposal or
recycling of pollutants including land-based alternatives; and
(G) the effect on alternate uses of the oceans, such as
mineral exploitation and scientific study.
(2) In any event, where insufficient information exists on
any proposed discharge to make a reasonable judgment on any of the
guidelines established pursuant to this subsection, no permit shall
be issued.
[SEC. 404 establishes a permit program to deal with
dredged or fill material. This was deemed insufficiently
related to toxic substances regulation to be included
in the compendium.]
TITLE V — GENERAL PROVISIONS
ADMINISTRATION
SEC. 501.
VI1 (a). The Administrator is authorized to prescribe such regulations
as are necessary to carry out his functions under this Act.
-------
FWPCA - 26
(b) The Administrator, with the consent of the head of any other
agency of the United States, may utilize such officers and employees of
such agency as may be found necessary to assist in carrying out the
purposes of this Act...
GENERAL DEFINITIONS
SEC. 502.
Except as otherwise specifically provided, when used in this
Act:...
(11) "Effluent limitation" means any restriction established
by a State or the Administrator on quantities, rates, and con-
centrations of chemical, physical, biological, and other con-
stituents which are discharged from point sources into navigable
waters, the waters of the contiguous zone, or the oceans, including
schedules of compliance...
(13) "Toxic pollutant" means those pollutants or combinations
of pollutants, including disease-causing agents, which after
discharge and upon exposure, ingestion, inhalation or assimilation
into any organism, either directly from the environment or
indirectly by ingestion through food chains, will cause death,
disease, behavioral abnormalities, cancer, genetic mutations,
physiological malfunctions (including malfunctions in reproduction)
or physical deformations, in such organisms or their offspring...
(15) "Biological monitoring" shall mean the determination of
the effects on aquatic life (including accumulation of pollutants
in tissue) in receiving waters due to the discharge of pollutants
(A) by techniques and procedures (including sampling of organisms
representative of appropriate levels of the food chain) appropriate
to the volume and the physical, chemical, and biological char-
acteristics of the effluent, and (B) at appropriate frequencies and
locations...
XVI (18) "Industrial user" means those industries identified in
the Standard Industrial Classification Manual, Bureau of the
Budget, 1967, as amended and supplemented, under the category
"Division D Manufacturing" and such other classes of significant
waste producers as, by regulation, the Administrator deems
appropriate.
XVI (19) "Pollution" means the man-made or man-induced alteration
of the chemical, physical, biological, and radiological integrity
of water.
-------
FWPCA - 27
ADMINISTRATIVE PROCEDURE AND JUDICIAL REVIEW
SEC. 509.
IX (a) (1) For purposes of obtaining information under section
305 [water quality inventory]... the Administrator may issue subpoenas
for the attendance and testimony of witnesses and the production of
relevant papers, books, and documents, and he may administer oaths.
XIV Except for effluent data, upon a showing satisfactory to the
Administrator that such papers, books, documents, or information or
particular part thereof, if made public, would divulge trade
secrets or secret processes, the Administrator shall consider such
record, report, or information or particular portion thereof
confidential in accordance with the purposes of section 1905 of
title 18 of the United States Code, except that such paper, book,
document, or information may be disclosed to other officers,
employees, or authorized representatives of the United States
concerned with carrying out this Act, or when relevant in any
proceeding under this Act.
IX (2) The district courts of the United States are authorized,
upon application by the Administrator, to issue subpoenas for
attendance and testimony of witnesses and the production of
relevant papers, books, and documents, for purposes of obtaining
information under subsections 304(b) [adopting or revising effluent
limitations] and (c) [developing information on processes, pro-
cedures and operating methods] of this Act. Any papers, books,
documents or other information or part thereof, obtained by reason
XIV of such a subpoena, shall be subject to the same [confidentiality]
requirements as are provided in paragraph (1) above...
EFFLUENT STANDARDS AND WATER QUALITY INFORMATION
ADVISORY COMMITTEE
IV SEC. 515.
[The Effluent Standards and Water Quality Information
Advisory Committee is currently not active and there
are no plans to make use of the Committee in the
future. This section of FWPCA is, therefore, not
contained in the compendium.]
-------
FWPCA - 28
REPORTS TO CONGRESS
II SEC. 516.
(a) Within ninety days following the convening of each session of
Congress, the Administrator shall submit to the Congress a report, in
addition to any other report required by this Act, on measures taken
toward implementing the objective of this Act, including, but not
limited to,... (2) a summary of actions taken and results achieved in
the field of water pollution control research, experiments, studies, and
related matters by the Administrator and other Federal agencies and by
other persons and agencies under Federal grants or contracts; (3) the
progress and problems associated with the development of effluent
limitations and recommended control techniques; ... (7) a summary of the
results of the survey required to be taken under section 210 of this
Act; ...
-------
PUBLIC LAW 93-523 -- December 16, 1974
as amended by
PUBLIC LAW 95-190 — November 16, 1977
"SAFE DRINKING WATER ACT"
Part A — DEFINITIONS
SEC. 1401.
For purposes of this title:
XVI (D "Primary drinking water regulation" means a regulation
which —
(A) applies to public water systems;
(B) specifies contaminants which, may have an adverse
effect on human health;
(C) specifies for each such contaminant either —
(i) a maximum contaminant level, or
(ii) each treatment technique which reduces the
level of the contaminant sufficiently to satisfy the
requirements of section 1412 below; and
(D) contains- criteria and procedures to assure a
supply of drinking water which dependably complies with
maximum contaminant levels.
XVI (2) "Secondary drinking water regulation" means a regulation
which applies to public water systems and which specifies the
maximum contaminant levels which are requisite to protect the
public welfare. Such regulations may apply to which may adversely
affect the odor or appearance of such water or which may otherwise
adversely affect the public welfare.
XVI (3) "Maximum contaminant level" means the maximum permissible
level of a contaminant in water is delivered to any user of a
public water system.
PART B ~ PUBLIC WATER SYSTEMS
NATIONAL DRINKING WATER REGULATIONS
H SEC. 1412...
(e) (1) The Administrator shall enter into appropriate
arrangements with the National Academy of Sciences or other
-------
SDWA - 2
independent scientific organization to conduct a study to determine
(A) the maximum contaminant levels which could be recommended [for
adoption as primary or secondary drinking water regulations] in
order to protect the health of persons from any known or anti-
cipated adverse effects, and (B) the existence of any contaminants
the levels of which cannot be determined in drinking water but
which may have an adverse effect on health.
(2) The result of the study shall be reported to Congress no
later than December 16, 1976, and updated reports shall be sent to
the Congress every two years. The report shall contain (A) a
summary and evaluation of relevant publications and unpublished
studies; (B) a statement of methodologies and assumptions for
estimating the levels at which adverse health effects may occur;
(C) a statement of methodologies and assumptions for estimating the
margin of safety which should be incorporated in the national
primary drinking water regulations; (D) proposals for recommended
maximum contaminant levels for national primary drinking water
regulations, based on the methodologies, assumptions, and studies
referred to above and in paragraph (4) below; (E) a list of
contaminants which cannot be measured in drinking water, but which
may have an adverse effect on health; (F) recommended studies and
test protocols for future research on the health effects of
drinking water contaminants, including a list of the major research
priorities and estimated costs necessary to conduct such priority
research; (G) periodic assessments and evaluations of unregulated
contaminants which may require continuous monitoring or regulation.
(3) In developing its proposals for recommended maximum
contaminant levels the National Academy of Sciences (or other
organization preparing the report) shall evaluate and explain the
impact of the following considerations:
(A) The existence of groups or individuals in the
population which are more susceptible to adverse effects than
the normal healthy adult.
i (B) The exposure to contaminants in other media than
drinking water (including exposures in food, in the ambient
air, and in occupational settings) and the resulting body
burden of contaminants.
(C) Synergistic effects resulting from exposure to or
interaction by two or more contaminants.
(D) The contaminant exposure and body burden levels
which alter physiological function or structure in a manner
reasonably suspected of increasing the risk of illness.
-------
SDWA - 3
(4) In making the study under this subsection, the National
Academy of Sciences (or other organization) shall collect and
correlate (A) morbidity and mortality data and (B) monitored data
on the quality of drinking water. Any conclusions based on such
correlations shall be included in the report of the study...
STATE PRIMARY ENFORCEMENT RESPONSIBILITY
SEC. 1413.
(a) For purposes of this title, a State has primary enforcement
responsibility for public water systems during any period for which the
Administrator determines that such State — ...
V (2) has adopted and is implementing adequate procedures for
the enforcement of such State regulations, including conducting
VIII such monitoring and making such inspections as the Administrator
may require by regulation;
VI (3) will keep such records and make such reports with
respect to its activities under paragraphs (1)' and (2) as the
Administrator may require by regulation;
PART C ~ PROTECTION OF UNDERGROUND SOURCES OF
DRINKING WATER
REGULATIONS FOR STATE PROGRAMS
SEC. 1421...
(b) (1) Regulations for State underground injection programs
shall contain minimum requirements for effective programs to prevent
underground injection which endangers drinking water sources. Such
regulations shall require that a State program —
X (A) by December 16, 1974, prohibit any underground
injection which is not authorized by a permit issued by
the State (except that the regulations may permit a State to
authorize underground injection by rule);
(B) require (i) that an applicant for a permit to inject
must satisfy the State that the underground "injection will not
endanger drinking water sources, and (ii) that no rule may be
promulgated which authorizes any underground injection which
endangers drinking water sources;
(C) include inspection, monitoring, record-keeping,
and reporting requirements; and ...
-------
SDWA - 4
(d) For purposes of this part:
(1) "Underground injection" means the subsurface
emplacement of fluids by well injection.
(2) Underground injection endangers drinking water sources
if such injection may result in the presence of any contaminant
which may result in a drinking water system not complying with any
national primary drinking water regulation or may otherwise
adversely affect health.
STATE PRIMARY ENFORCEMENT RESPONSIBILITY
SEC. 1422...
(b) (1) (A) [An application for approval of a State's under-
ground injection control program must include assurance
that the State] . . .
(ii) will keep such records and make such reports
with respect to its activities under its underground
injection control program as the Administrator may
require by regulation...
PART E — GENERAL PROVISIONS
RESEARCH, TECHNICAL ASSISTANCE, INFORMATION, AND
TRAINING OF PERSONNEL
II SEC. 1442.
(a) (1) The Administrator may conduct research, studies and
demonstrations relating to the causes, diagnosis, treatment,
control, and prevention of physical and mental diseases and other
impairments of man resulting directly or indirectly from contaminants
in water, or relating to the provision of a dependably safe supply
of drinking water, including —
(A) improved methods (i) to identify and measure the
existence of contaminants in drinking water, and (ii) to
identify the source of such contaminants;
(B) improved methods to identify and measure the health
effects of contaminants in drinking water; ... and
(E) improved methods of protecting underground water
sources of public water systems from contamination.
-------
SDWA - 5
III (2) (A) The Administrator shall, to the maximum extent
feasible, provide technical assistance to the States and
municipalities in the establishment and administration of
public water system supervision programs...
(4) The Administrator shall conduct a survey and study of —
(A) disposal of waste (including residential waste)
which may endanger underground water which supplies, or can
reasonably be expected to supply, any public water system, and
(B) means of control of such waste disposal.
Not later than December 16, 1975, he shall transmit to the
Congress the results of such survey and study, together with such
recommendations as he deems appropriate.
(5) The Administrator shall carry out a study of methods
of underground injection which do not result in the degradation of
underground drinking water sources.
(6) The Administrator shall carry out a study of methods of
preventing, detecting, and dealing with surface spills of con-
taminants which may degrade underground water sources for public
water systems...
(8) The Administrator shall carry out a study of the
nature and extent of the impact on underground water supplies of
(A) abandoned injection or extraction wells; (B) intensive
application of pesticides and fertilizers in underground water
recharge areas; and (C) ponds, pools, lagoons, pits, or other
surface disposal of contaminants in underground water recharge
areas...
RECORDS AND INSPECTIONS
SEC. 1445.
VII (a) Every person who is a supplier of water who is subject to a
y primary drinking water regulation or to an applicable underground
injection control program... shall establish and maintain such records,
make such reports, conduct such monitoring, and provide such information
as the Administrator may reasonably require by regulation to assist him
in establishing regulations under this title, in determining whether
such person has acted or is acting in compliance with this title... in
evaluating the health risks of unregulated contaminants, or in advising
the public of such risks.
-------
SDWA - 6
(b) (1) Except as provided in paragraph (2), the Administrator,
or his representative, upon presenting appropriate credentials and
a written notice to any supplier of water or other person subject
to (A) a national primary drinking water regulation, (B) an
applicable underground injection control program, or (C) any
requirement to monitor an unregulated contaminant pursuant to
subsection (a) above, is authorized to enter any establishment,
facility, or other property of such supplier or other person in
order to determine whether such person has acted or is acting in
compliance with this title, including for this purpose, inspection,
at reasonable times, of records, files, papers, processes,
controls, and facilities, or in order to test any feature of a
public water system, including its raw water source...
(1) Subject to paragraph (2), upon a showing satisfactory
to the Administrator by any person that any information required
under this section from such person, if made public, would divulge
trade secrets or secret processes of such person, the Administrator
shall consider such information confidential in accordance with
the purposes of section 1905 of title 18 United States Code. If
the applicant fails to make a showing satisfactory to the
Administrator, the Administrator shall give such applicant
thirty days notice before releasing the information (unless
the public health or safety requires earlier release of such
information) .
GENERAL PROVISIONS
VH SEC. 1450.
(a) (1) The Administrator is authorized to prescribe such
regulations as are necessary or appropriate to carry out his
functions under this title...
-------
[21 USC 301-392 — As amended through October, 1976]
"FEDERAL FOOD, DRUG, AND COSMETIC ACT"
CHAPTER II — DEFINITIONS
SEC. 201.
For the purposes of this Act — ...
(c) "Department" means the U.S. Department of Health, Education,
XVI and Welfare...
(f) "Food" means (1) articles used for food or drink for man
or other animals, (2) chewing gums, and (3) articles used for components
of any such article.
(g) (1) "Drug" means (A) articles recognized in the official
United States Pharmacopeia, official Homeopathic Pharmacopeia
of the United States, or official National Formulary, or any
supplement to any of them; and (B) articles intended for use in
the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals; and (C) articles (other than food)
intended to affect the structure or any function of the body of man
or other animals; and (D) articles intended for use as a component
of any articles specified in clause (A), (B), or (C), but does not
include devices or their•components, parts, or accessories.
[Note: Devices are not considered in this compendium because of
their lack of chemical action and concomitant non-toxic nature,
ed. ]...
(i) "Cosmetic" means (1) articles intended to be rubbed, poured,
sprinkled or sprayed on, introduced into or otherwise applied to the
human body or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and (2) articles intended
for use as components of such articles, except that such term does not
include soap.
(j) "Official compendium" means the official United States
Pharmacopeia, official Homeopathic Pharmacopeia of the United.States,
official National Formulary, or any supplement to any of them.
(k) "Label" means a display of written, printed, or graphic matter
upon the immediate container of any article. Any information required
under this Act to appear on a label shall appear on the
container or wrapper or be easily legible through the ojutside container
or wrapper...
outside
-------
FD&CA - 2
XVI (m) "Labeling" means all labels and other written, printed, or
graphic matter upon any article or any of its containers or wrappers, or
accompanying such article.
(n) In determining whether an article is misbranded because the
labeling or advertising is misleading, the Secretary shall take into
account (among other things) not only representations made or suggested
by statement, word, design, or device or combination thereof, but also
the extent to which the labeling or advertising fails to reveal facts
material in the light of such representations or material with respect
to consequences which may result from the use of the article as
prescribed in the labeling or advertising or under customary or usual
conditions of use...
(p) "New drug" means —
(1) Any human drug which is not generally recognized, among
qualified experts, as safe and effective for use under the
conditions prescribed, recommended or suggested in the labeling,
exclusive of any drug subject to the Food and Drugs Act of June 30,
1906, if at such time its labeling contained the same representations
concerning the conditions of its use; or
(2) Any human drug which, as a result of investigations to
determine its safety and effectiveness, has become recognized as
safe but which has not been extensively used.
XVI (q) "Pesticide chemical" means any substance which alone or in
chemical combination or in formulation with one or more other substances
is a pesticide within the meaning of the Federal Insecticide, Fungicide,
and Rodenticide Act and which is used in the production, storage, or
transportation of raw agricultural commodities.
(r) "Raw agricultural commodity" means any food in its raw or
natural state, including all fruits that are washed, colored or otherwise
treated in their unpeeled natural form prior to marketing.
yvT (s) "Food additive" means any substance which may, as a result of
its intended use, directly or indirectly, become a component of or
otherwise affect the characteristics of any food (including any
substance used in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food if such
substance is not generally recognized by qualified experts as safe under
the conditions of its intended use; except that such term does not
include —
(1) a pesticide chemical in or on a raw agricultural
commodity;
(2) a pesticide chemical used in the production, storage,
or transportation of any raw agricultural commodity;
-------
XVI
FD&CA - 3
(3) any color additive;
(4) any substance regulated under the Poultry Products
Inspection Act or the Meat Inspection Act of March 4, 1907; or
(5) a new animal drug.
(t) (1) "Color additive" means —
(A) a dye, pigment, or other substance made by synthesis
or extracted, isolated, or otherwise derived, with or without
intermediate or final change of identity, from a vegetable,
animal, mineral, or other source, and
(B) when added to a food, drug, or cosmetic, or to the
human body, is capable of imparting color and is used for such
purpose.
(2) "Color" includes black, white, and intermediate grays.
XVI (u) "Safe" as used in paragraph (s) above and in sections 409,
512, and 706, has reference to the health of man or animal...
CHAPTER III — PROHIBITED ACTS
AND PENALITIES
PROHIBITED ACTS
XVII SEC. 301.
The following acts and the causing thereof are prohibited:
(a) The introduction or delivery for introduction into interstate
commerce of any food, drug, device, or cosmetic that is adulterated or
misbranded.
(b) The adulteration or misbranding of any food, drug, device, or
cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device,
or cosmetic that is adulterated or misbranded, and the delivery or
proffered delivery thereof for pay or otherwise...
(e) The refusal to permit access to or copying of any record as
required by section 703 [records of interstate shipment]; or the failure
to establish or maintain any record, or make any report, required under
section 505(i) or (j) [new drug research]; 507 (d) or (g) [batch
certification of antibiotics], 512 (j), (1) or (m), 515 (f) or 519, or
the refusal to permit access to or verification or copying of any such
required record.
-------
FD&CA - 4
(f) The refusal to permit entry or inspection as authorized by
section 704 [factory inspection].
(g) The manufacture within any Territory of any food, drug, device
or cosmetic that is adulterated or misbranded...
(j) The (1) using by any person to his own advantage, or (2)
revealing, other than to the Secretary or officers of the Department, or
to the courts, of any information acquired under the authority of
XIV section 404, 409, 505, 506, 507, 510, 512, 513, 514, 515, 516, 518, 519,
520, 704, 706, or 708 concerning any method or process which is a trade
secret.
[The table below is not contained in the Act, but is put here for the
convenience of the reader.]
Section 404 Emergency permit control
Section 409 Food additives
Section 505 New drugs
Section 506 Certification of drugs containing insulin
Section 507 Certification of antibiotics
Section 510 Registration of producers of drugs and devices
Section 512 New animal drugs
Section 513 Classification of devices intended for human
use
Section 514 Performance standards
Section 515 Premarket approval
Section 516 Banned devices
Section 518 Notification and other remedies
Section 519 Records and reports on devices
Section 520 General provisions respecting control of devices
intended for human use
Section 704 Factory inspection
Section 706 Listing and certification of color additives for
foods, drugs, and cosmetics
Section 708 Confidential information
(o) The failure of any manufacturer, packer, or distributor of a
prescription drug to maintain or transmit, to any licensed practitioner
yr, who makes written request for information about such drug, true and
correct copies of all printed matter which is required to be included in
any package in which that drug is distributed or sold, or such other
printed matter as is approved by the Secretary.
(p) The failure to register in accordance with section 510, the
failure to provide any information required by section 510(j) or 510(k),
or the failure to provide a notice required by section 510(j)(2)...
-------
FD&CA - 5
[The subpoena authority in section 307 is not included
because it does not accrue to the Secretary or the
Administrator and because it is related to violation
and enforcement actions rather than information develop-
ment activities.j
CHAPTER IV — FOOD
DEFINITIONS AND STANDARDS FOR FOOD
II SEC. 401.
Whenever, in the judgment of the Secretary, such action will
promote honesty and fair dealing in the interest of consumers, he shall
promulgate regulations fixing and establishing for any food, under its
common or usual name so far as practicable, a reasonable definition and
standard of identity, a reasonable standard of quality, and/or reasonable
standards of fill of container ...
In prescribing a definition and standard of identity for any food
or class of food in which optional ingredients are permitted, the
Secretary shall, for the purpose of promoting honesty and fair dealing
in the interest of consumers, designate the optional ingredients which
shall be named on the label ...
ADULTERATED FOOD
XVI SEC. 402.
A food shall be deemed to be adulterated —
(a) (1) If it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case the
substance is not an added substance, such food shall not be
considered adulterated under this clause if the quantity of such
substance in such food does not ordinarily render it injurious to
health; or
(2) (A) If it bears or contains any added poisonous or
added deleterious substance which is unsafe within the meaning of
section 406; or (B) if it is a raw agricultural commodity and it
bears or contains a pesticide chemical which is unsafe within the
meaning of such section 408(a); or (C) if it is or it bears or
contains any food additive which is unsafe within the meaning of
section 409: Provided, that where a pesticide chemical has been
used in or on a raw agricultural commodity in conformity with
-------
FD&CA - 6
an exemption granted or a tolerance prescribed under section 408
and sucty raw agricultural commodity has been subjected to
processing such as canning, cooking, freezing, dehydrating, or
milling! the residue of such pesticide chemical remaining in or on
such p^cessed food shall, notwithstanding the provisions of
sections 406 and 409, not be deemed unsafe if such residue in or on
the rav agricultural commodity has been removed to the extent
possible in good manufacturing practice and the concentration of
such residue in the processed food when ready to eat is not greater
than the tolerance prescribed for the raw agricultural
commodity...; or
(3) If it consists, in whole or in part, of any filthy,
putrid, or decomposed substance, or if it is otherwise unfit
fo'r food; or
(4) If it has been prepared, packed, or held under unsanitary
Conditions whereby it may have become contaminated with filth ...
or whereby it may have been rendered injurious to health, ...;
or ...
(6) If its container is composed,.in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health ...
(b) (1) If any valuable constituent has been, in whole or in
part, omitted or abstracted therefrom; or
(2) If any substance has been substituted wholly or in part
therefor; or
(3) If damage or inferiority has been concealed in any
manner; or
(4) If any substance has been added thereto or mixed or
packed therewith so as to increase its bulk or weight, or reduce
its quality or strength, or make it appear better or of greater
value than it is.
(c) If it is, or it bears or contains, a color additive which
is unsafe within the meaning of section 706(a).
(d) If it is confectionery, and —
(1) has partially or completely imbedded therein any
non-nutritive object...;
(2) bears or contains any alcohol other than alcohol not
in excess of one-half of 1 per centum by volume derived solely
from the use of flavoring extracts; or
(3) bears or contains any non-nutritive substance...;
-------
FD&CA - 7
MISBRANDED FOOD
XV SEC. 403.
A food shall be deemed to be misbranded —
(a) If (1) its labeling is false or misleading in any particular,
or (2) in the case of a food to which section 411 [vitamins and
minerals] applies, its advertising is false or misleading in a material
respect or its labeling is in violation of section 411(b)(2).
(b) If it is offered for sale under the name of another food.
(c) If it is an imitation of another food, unless its label bears,
in type of uniform size and prominence, the word "imitation" and,
immediately thereafter, the name of the food imitated...
(e) If in a package form, unless it bears a label containing (1)
the name and place of business of the manufacturer, packer, or distri-
butor; and (2) an accurate statement of the quantity of the contents in
terms of weight, measure, or numerical count.
(f) If any word, statement, or other information required by or
under authority of this Act to appear on the label or labeling is not
prominently placed thereon, with such conspicuousness and in such terms
as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
(g) If it purports to be or is represented as a food for which a
definition and standard of identity has been prescribed under section
401, unless (1) it conforms to such definition and standard, and (2) its
label bears the name of the food as specified in the definition and
standard, and, insofar as may be required by such regulations, the
common names of optional ingredients (other than spices, flavoring, and
coloring) present in such food...
(i) If it is not subject to the provisions of paragraph (g) of
this section unless its label bears (1) the common or usual name of the
food, if any, and (2) in case it is fabricated from two or more ingredients,
the common or usual name of each ingredient, except that spices,
flavorings, and colorings, other than those sold as such, pay be
designated as spices, flavorings, and colorings without naming each:
Provided, that, to the extent that compliance with the requirements of
clause (2) of this paragraph is impracticable, or results in deception
or unfair competition, exemptions shall be established by regulations
promulgated by the Secretary.
(j) If it purports to be or is represented for special dietary
uses, unless its label bears such information concerning its vitamin,
mineral, and other dietary properties as the Secretary determines to be,
and by regulations prescribes as, necessary in order to fully inform
purchasers as to its value for such uses.
-------
FD&CA - 8
(k) If it bears or contains any artificial flavoring, Artificial
coloring, or chemical preservative, unless it bears labeling Stating
that fact. The provisions of this paragraph with respect to chemical
preservatives shall not apply to a pesticide chemical when used\£n or on
a raw agricultural commodity which is the produce of the soil.
(1) If it is a raw agricultural commodity which is the produce\
of the soil, bearing or containing a pesticide chemical applied after
harvest, unless the shipping container of such commodity bears
labeling which declares the presence of such chemical in or on
such commodity and the common or usual name and the function of such
chemical ...
TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD
SEC. 406.
Any poisonous or deleterious substance added to any food, except
where required in the production thereof or unavoidable by good
manufacturing practice, shall be deemed unsafe and the food deemed
adulterated, but when such substance is required or cannot be avoided,
the Secretary shall promulgate regulations limiting the quantity as he
finds necessary for the protection of public health, and any greater
quantity shall be deemed unsafe and the food deemed adulterated. While
a regulation is in effect limiting the quantity of any substance in any
food, such food shall not, by reason of containing any added amount of
such substance, be considered adulterated. In determining the quantity
of such added substance to be tolerated in different articles of food,
the Secretary shall take into account the extent to which such substance
is required or unavoidable in the production of such article, and any
other ways in which the consumer may be affected by the same or other
poisonous or deleterious substances.
TOLERANCES FOR PESTICIDE CHEMICALS IN OR ON RAW
AGRICULTURAL COMMODITIES
SEC. 408...
(b) The Secretary* shall establish tolerances for use (in or on
raw agricultural commodities) of poisonous or deleterious pesticide
*Responsibilities for establishing tolerances under this section
were transferred by Executive Order to the Environmental Protection Agency.
-------
FD&CA - 9
chemicals and of pesticide chemicals which are not generally recognized
by qualified experts as safe for use, to the extent necessary to protect
the public health. The Secretary shall give appropriate consideration,
among other relevant factors, (1) to the necessity for the production of
an adequate, wholesome, and economical food supply; (2) to the other
ways in which the consumer may be affected by the same pesticide
chemical or by other related substances; and (3) to the opinion of the
Secretary of Agriculture as submitted with a certification of usefulness
under this section. The Secretary may establish a tolerance at zero
level if the scientific data before him do not justify the establishment
of a greater tolerance.
(c) The Secretary shall exempt any pesticide chemical from the
necessity of a tolerance when such a tolerance is not necessary to
protect the public health.
(d) (1) Any person who has registered, or has applied for
XII registration of an economic poison under the Federal Insecticide,
Fungicide, and Rodenticide Act may petition the Secretary, proposing
establishing a tolerance for a pesticide chemical which constitutes,
or is an ingredient of such economic poison, or proposing exempting
the pesticide chemical from the requirement of a tolerance. The
petition shall contain —
(A) the name, chemical identity, and composition of
the pesticide chemical;
I (B) the amount, frequency, and time of application of
the pesticide chemical;
(C) full reports of investigations made with respect to
the safety of the pesticide chemical;
I (D) the results of tests on the amount of residue
remaining, including a description of the analytical methods
used;
(E) practicable methods for removing residue which
exceeds any proposed tolerance;
(F) proposed tolerances for the pesticide chemical if
tolerances are proposed; and
(G) reasonable grounds in support of the petition.
Samples of the chemical shall be furnished to the Secretary upon
request. Notice of the filing of such petition shall be published
in general terms by the Secretary within thirty days after filing.
Such notice shall include the analytical methods available for the
determination of the residue of the pesticide chemical for which a
tolerance or exemption is proposed.
-------
FD&CA - 10
X (2) Within ninety days after certification of usefulness by
the Secretary of Agriculture the Secretary shall, by order make
public a regulation —
(A) establishing a tolerance for the pesticide chemical,
or
(B) exempting the pesticide chemical from the necessity
of a tolerance,
unless the person filing the petition requests or the Secretary
decides that the petition should be referred to an advisory
committee.
(3) If necessary, the Secretary shall submit the petition
and any other data before him to an advisory committee. Not later
than sixty days thereafter, the committee shall certify to the
Secretary a report and recommendations on the proposal together
with all underlying data and a statement of the reasons or basis
for the recommendations. The sixty-day period may be extended by
the advisory committee for an additional thirty days. Within
thirty days, the Secretary shall then, by order, make public a
regulation —
(A) establishing a tolerance for the pesticide chemical;
or
(B) exempting the pesticide chemical from the necessity
of a tolerance...
(e) The Secretary may at any time, upon his own initiative or upon
the request of any interested person, propose establishing a tolerance
for a pesticide chemical or exempting it from the necessity of a
tolerance. Thirty days after publication of such a proposal, the
Secretary may by order publish a regulation based upon the proposal
which shall become effective upon publication unless within such
thirty-day period a person who has registered, or who has submitted an
application for the registration of, a pesticide under the Federal
Insecticide, Fungicide, and Rodenticide Act containing the pesticide
chemical names in the proposal, requests that the proposal be referred
to an advisory committee. In the event of such a request, the Secretary
shall forthwith submit the proposal and other relevant data before him
to an advisory committee to be appointed in accordance with subsection
(g), below. As soon as practicable after such referral, but not later
than sixty days thereafter, unless extended as hereinafter provided, the
committee shall, after independent study of the data submitted to it by
the Secretary and other data before it, certify to the Secretary a
report and recommendations on the proposal together with all underlying
-------
FD&CA - 11
data and a statement of the reasons or basis for the recommendations.
The sixty-day period provided for herein may be extended by the advisory
committee for an additional thirty days if the advisory committee deems
this necessary. Within thirty days after such certification, the
Secretary may, after giving due consideration to all data before him,
including such report, recommendations, underlying data and statement,
by order publish a regulation establishing a tolerance for the pesticide
chemical names in the proposal or exempting it from the necessity of a
tolerance which shall become effective upon publication. Regulations
issued under this subsection shall upon publication be subject to
paragraph (5) of subsection (d).
(f) All data submitted to the Secretary or to an advisory
committee in support of a petition under this section shall be con-
sidered confidential by the Secretary and by such advisory committee
until publication of a regulation under paragraph (2) or (3) of
subsection (d) of this section. Until such publication, such data shall
not be revealed to any person other than those authorized by the Secretary
or by an advisory committee in the carrying out of their official duties
under this section.
(h) A person who has filed a petition or who has requested the
referral of a proposal to an advisory committee in accordance with the
provision of this section, as well as representatives of the Department
of Health, Education, and Welfare, shall have the right to consult with
any advisory committee provided for in subsection (g) in connection with
the petition or proposal...
II (j) The Secretary may, upon the request of any person who has
obtained an experimental permit for a pesticide chemical under the
Federal Insecticide, Fungicide, and Rodenticide Act or upon his own
initiative, establish a temporary tolerance for the pesticide chemical
for the uses covered by the permit whenever in his judgment such action
is deemed necessary to protect the public health, or may temporarily
exempt such pesticide chemical from a tolerance. In establishing such a
tolerance, the Secretary shall give due regard to the necessity for
experimental work in developing an adequate, wholesome, and economical
food supply and to the limited hazard to the public health involved in
such work when conducted in accordance with applicable regulations under
the Federal Insecticide, Fungicide, and Rodenticide Act...
XI (1) The Secretary of Agriculture, upon request of any person who
has registered, or who has submitted an application for the registration
of, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide
Act, and whose request is accompanied by a copy of a petition filed by
such person under subsection (d)(1) with respect to a pesticide chemical
which constitutes, or is an ingredient of, such [a pesticide], shall,
within thirty days, or within sixty days if upon notice prior to the
termination of such thirty days the Secretary deems it necessary to
postpone action for such period, on the basis of data before him,
either —
-------
FD&CA - 12
(1) certify to the Secretary of Health, Education, and Welfare
that such pesticide chemical is useful for the purpose for which a
tolerance or exemption is sought; or
(2) notify the person requesting the certification of his
proposal to certify that the pesticide chemical does not appear to
be useful for the purpose for which a tolerance or exemption is
sought, or appears to be useful for only some of the purposes for
which a tolerance or exemption is sought.
In the event that the Secretary of Agriculture takes the action
described in clause (2) of the preceding sentence, the person requesting
the certification, within one week after receiving the proposed
certification, may either (A) request the Secretary of Agriculture to
certify to the Secretary of Health, Education, and Welfare on the basis
of the proposed certification; (B) request a hearing on the proposed
certification or the parts thereof objected to; or (C) request both such
certification and such hearing. If no such action is taken, the
Secretary may by order make the certification as proposed. In the event
that the action described in clause (A) or (C) is taken, the Secretary
of Agriculture shall provide an opportunity for a prompt hearing. The
certification of the Secretary of Agriculture as the result of such
hearing shall be made by order and shall be based'only on substantial
evidence of record at the hearing and shall set forth detailed findings
of fact. In no event shall the time elapsing between the making of a
request for a certification under this subsection and final certifi-
cation by the Secretary of Agriculture exceed one hundred and sixty
days. The Secretary shall submit to the Secretary of Health, Educa-
tion, and Welfare with any certification of usefulness under this
subsection an opinion, based on the data before him, whether the
tolerance or exemption proposed by the petitioner reasonably reflects
the amount of residue likely to result when the pesticide chemical is
used in the manner proposed for the purpose for which the certification
is made. The Secretary of Agriculture, after due notice and opportunity
for public hearing, is authorized to promulgate rules and regulations
for carrying out the provisions of this subsection...
FOOD ADDITIVES
UNSAFE FOOD ADDITIVES
SEC. 409.
XVI (a) A food additive shall, with respect to any particular use or
intended use, be deemed unsafe and the food adulterated unless —
-------
FD&CA - 13
(1) the additive and its use conform to an exemption in
effect pursuant to this section; or
(2) there is a regulation issued under this section pre-
scribing the conditions under which such additive may be safely
used and that regulation is complied with. . .
PETITION TO ESTABLISH SAFETY*
(b) (1) Any person may file with the Secretary a petition
proposing the issuance of a regulation prescribing the conditions
under which such additive may be safely used.
(2) Such petition shall, in addition to any explanatory
or supporting data, contain —
(A) the name and all pertinent information concerning
such food additive, including, where available, its chemical
identity and composition;
(B) a statement of the conditions of the proposed use of
such additive, including all directions, recommendations, and
suggestions proposed for the use of such additive, and
including specimens of its proposed labeling;
(C) all relevant data bearing on the physical or other
technical effects such' addition is intended to produce, and
the quantity of such addition required to produce such effect;
(D) a description of practicable methods for determining
the quantity of such additive in or on food, and any
substance formed in or on food, because of its use; and
(E) full reports of investigations made with respect
to the safety of use of such additive, including full infor-
mation on the methods and controls used in conducting such
investigations .
(3) Upon request of the Secretary, the manufacturer of such
additive shall furnish a full description of the methods used in,
and the facilities and controls used for, the production of such
additive.
(4) Upon request of the Secretary, the petitioner shall
furnish samples of the food additive involved, or articles used as
components thereof, and of the food in or on which the additive is
proposed to be used...
* EPA is responsible for establishing food additive regulations for
pesticide chemicals when processing raw agricultural commodities
results in concentration of pesticide residues.
-------
FD&CA - 14
ACTION ON THE PETITION
II (c) (1) The Secretary shall —
(A) by order establish a regulation prescribing
[among other things]... any directions or other labeling or
packaging requirements for such additive deemed necessary by
him to assure the safety of such use; or
(B) by order deny the petition...
(3) No such regulation shall issue if a fair evaluation of
the data before the Secretary —
(A) fails to establish that the proposed use of the
food additive will be safe: Provided, that no additive shall
be deemed to be safe if it is found to induce cancer when
ingested by man or animal, or if it is found, after tests
which are appropriate for the evaluation of the safety of food
additives, to induce cancer in man or animal, except that
this proviso shall not apply with respect to the use of a
substance as an ingredient of animals which are raised for
food production if the Secretary finds (i) that, under the
conditions of use and feeding specified in proposed labeling
and reasonably certain to be followed in practice, such
additive will not adversely affect the animals for which such
feed is intended, and (ii) that no residue of the additive
will be found (by methods of examination prescribed or
approved by the Secretary by regulations, which regulations
shall not be subject to objections, public hearings or
judicial review) in any edible portion of such animal after
slaughter or in any food yielded by or derived from the living
animal; or
(B) shows that the proposed use of the additives would
promote deception or otherwise result in misbranding or
adulteration.
(4) ... the Secretary —
(A) shall not fix a tolerance limitation at a level
higher than required to accomplish the physical or other
technical effect for which such additive is intended; and
(B) shall not establish a regulation for such proposed
use if he finds that the data do not establish that such use
would accomplish the intended physical or other technical
effect.
-------
FD&CA - 15
(5) In determining whether a proposed use of a food additive
is safe, the Secretary shall consider —
(A) the probable consumption of the additive and of
any substance formed in or on food because of the use of the
additive;
(B) the cumulative effect of such additive in the diet
of man or animals, taking into account any chemically or
pharmacologically related substance or substances in such
diet; and
(C) safety factors which are generally recognized as
appropriate for the use of animal experimentation data.
REGULATION ISSUED ON SECRETARY'S INITIATIVE
H (d) The Secretary may at any time, upon his own initiative,
propose the conditions under which an additive may be safely used, and
the reasons therefor. After the thirtieth day following publication of
such a proposal, the Secretary may by order establish a regulation based
upon his proposal ...
iv (f) (1) ... any person adversely affected by an order under
subsection (c) or (d) above, may request a hearing...
EXEMPTIONS FOR INVESTIGATIONAL USE
X (i) the Secretary shall provide for exempting from the require-
ments of this section any food additive, and any food bearing or
containing such additive, intended solely for investigational use by
qualified experts when in his opinion such exemption is consistent with
the public health.
[SEC. 411, VITAMINS AND MINERALS, is omitted because of the
improbability that these substances will ever be important
in toxic substances regulation.]
-------
FD&CA - 16
CHAPTER V — DRUGS AND DEVICES*
ADULTERATED DRUGS AND DEVICES
XVI SEC. 501.
A drug or device shall be deemed to be adulterated —
(a) ...; (3) if its container is composed, in whole or in part, of
any poisonous or deleterious substance which may render the contents
injurious to health; (4) if it bears or contains, for purposes of
coloring only, a color additive which is unsafe within the meaning of
section 706(a) ...; (5) if it is a new animal drug which is unsafe
within the meaning of section 512; or (6) if it is an animal feed
bearing or containing a new animal drug, and such animal feed is unsafe
within the meaning of section 512.
(b) If it is a drug and its strength differs from, or its quality
or purity falls below, the standards set forth in an official compendium.
Such determination as to strength, quality, or purity shall be made in
accordance with the tests or methods of assay set forth in such compendium,
except when tests or methods as are prescribed are, in the judgment of
the Secretary, insufficient for making such determination. In such
case, the Secretary shall bring that fact to the attention of the body
charged with the revision of such compendium. If such body fails to
prescribe tests or methods of assay which are sufficient, the Secretary
shall prescribe appropriate tests or methods of assay ...
MISBRANDED DRUGS AND DEVICES
XVI SEC. 502.
IX
A drug or device shall be deemed to be misbranded —
(a) If its labeling is false or misleading in any particular.
(b) If in a package form, unless it bears a label containing (1)
the name and place of business of the manufacturer, packer, or dis-
tributor; and (2) an accurate statement of the quantity of the contents
in terms of weight, measure, or numerical count.
* Because of their non-chemical nature and consequent non-toxic
nature, most provisions dealing with or referring to devices are
omitted from the compendium.
-------
FD&CA - 17
(c) If any word, statement, or other information required by or
under authority of this Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness and in such terms
as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
(d) If it is for use by man and contains any quantity of the
narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-
eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine,
heroin, marijuana, morphine, opium, paraldehyde, peyote, or sulfon-
methane; or any chemical derivative of such substance, which derivative
has been, after investigation, found by the Secretary to be habit
forming; unless its label bears the name, and quantity or proportion of
such substance or derivative and in juxtaposition therewith the statement
"Warning — May be habit-forming".
(e) (1) If it is a drug, unless (A) its label bears the
established name and quantity of each active ingredient, including
the quantity, kind, and proportion of any alcohol, and also
including, whether active or not, the established name and quantity
or proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, amidopyrine, antipyrine, atr.opine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury,
ouabain, strophanthin, strychnine, thyroid, or any derivative or
preparation of such substances, contained therein...
(3) As used in subparagraph (1) "established name'1 means (A)
the applicable official name designated purusant to section 508, or
(B) if such drug or ingredient is recoginzed in an official
compendium, then the official title in such compendium, or (C) if
neither (A) or (B) applies, then the cpmmon or usual name.
(f) Unless its labeling bears (1) adequate directions for use; and
(2) such adequate warnings against use in those pathological conditions
or by children where its use may be dangerous to health, or against
unsafe dosage or methods or duration of administration or application,'
in such manner and form as are necessary for the protection of users ...
(g) If it purports to be a drug the name of which is recognized in
an offical compendium, unless it is packaged and labeled as prescribed
therein...
(j) If it is dangerous to health when used in the dosage or
manner, or with the frequency or duration prescribed, recommended, or
suggested in the labeling thereof...
-------
FD&CA - 18
NEW DRUGS
SEC. 505.
(a) No person shall introduce or deliver for introduction into
interstate commerce any new drug, unless an approval of an application
filed pursuant to subsection (b) below is effective with respect to such
drug.
(b) Any person may file with the Secretary an application with
respect to any new drug. Such person shall submit to the Secretary as a
z part of the application (1) full reports of investigations which have
been made to show whether or not such drug is safe for use and whether
XII such drug is effective in use; (2) a full list of the articles used as
XII components of such drug; (3) a full statement of the composition of such
drug; (4) a full description of the methods used in, and the facilities
and control used for the manufacture, processing, and packaging of such
drug; (5) samples of such drug and of the articles used as components
thereof as the Secretary may require; and (6) specimens of the labeling
proposed to be used for such drug.
(c) Within one hundred and eighty days after the filing of an
application under this subsection, or such additional period as may be
agreed upon by the Secretary and the applicant, the Secretary shall
either —
(1) approve the application if he then finds that none
of the grounds for denying approval specified in subsection (d)
below applies, or
(2) give the applicant notice of an opportunity for a hearing
before the Secretary under subsection (d) on the question of
whether such application is approvable.
II (d) If the Secretary finds, after due notice and opportunity for a
II hearing that (1) the investigations do not include adequate tests by all
methods reasonably applicable to show whether or not such drug is safe
for use under the conditions prescribed, recommended, or suggested in
the proposed labeling; (2) the results of such tests show that such drug
is unsafe for use under such conditions or do not show that such drug is
safe for use under such conditions; (3) the methods used in, and the
facilities and controls used for, the manufacture, processing, and
packaging of such drug are inadequate to preserve its identity,
strength, quality, and purity; (4) he has insufficient information to
determine whether such drug is safe for use under such conditions; or
(5) there is a lack of substantial evidence that the drug will have the
-------
FD&CA - 19
effect it purports or is represented to have; or (6) such labeling is
false or misleading in any particular; he shall issue an order refusing
to approve the application. If, after notice and opportunity for
hearing, the Secretary finds that clauses (1) through (6) do not apply,
he shall issue an order approving the application. As used in this
subsection and subsection (e) below, "substantial evidence" means
evidence consisting of adequate and well-controlled investigations,
including clinical investigations by experts on the basis of which it
could fairly and responsibly be concluded by experts that the drug will
have the effect it purports or is represented to have...
VI (e) ...: Provided, that if the Secretary finds that there is an
XII imminent hazard to the public health, he may suspend the approval of
VIII such application immediately ... The Secretary may also, after due
notice to the applicant and opportunity for hearing, withdraw the
approval of an application with respect to any drug under this section
if the Secretary finds (1) that the applicant has failed to establish a
system for maintaining required records, or has repeatedly or
deliberately failed to maintain such records or to make required
reports, in accordance with a regulation or order under subsection (j)
or to comply with the notice requirements of paragraph 510(j)(2), or the
applicant has refused to permit access to, or copying or verification
of such records as required...
X (i) The Secretary shall by regulation exempt from this section
drugs intended solely for investigational use by experts. Such
regulations may (in the discretion of the Secretary) among other
conditions, require —
(1) submission (before any clinical testing of a new drug
* is undertaken) of reports of investigations or preclinical tests
adequate to justify the proposed clinical testing;
(2) obtaining a signed agreement from each investigator that
XI patients to whom the drug is administered will be under his
personal supervision, or under the supervision of investigators
responsible to him, and that he will not supply such drug to any
other investigator, or to clinics, for administration to human
beings; and
VII (3) establishment and maintenance of such records, and the
making of such reports as the Secretary finds will enable him to
VI evaluate the safety and effectiveness of such drug in the event of
the filing of an application pursuant to section (b) above.
XI Such regulations shall require investigators to certify to the sponsor
that they will inform any human beings to whom such drugs or any
controls are being administered (or their representatives), that such
drugs are being used for investigational purposes, and that the consent
-------
FD&CA - 20
of such human beings (or their representatives) will be obtained except
where they deem it not feasible or, in their professional judgment,
contrary to the best interests of such human beings. Nothing in this
subsection shall be construed to require any clinical investigator to
submit directly to the Secretary reports on the investigational use of
drugs.
(j) (1) In the case of any approved application, the applicant
shall establish and maintain such records, and make such reports —
VI of data relating to clinical experience and other data or infor-
mation, received or otherwise obtained by such applicant with
respect to such drug — as the Secretary may by general regulation,
or by special order, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the Secretary
to determine, or facilitate a determination, whether there is or
may be grounds for invoking subsection (e) of this section
[withdrawal or suspension of approval]...
VIII (2) Every person required under this section to maintain
records, and every person in charge or custody thereof, shall, upon
request of an officer designated by the Secretary, permit such
officer at all reasonble times to have access to and to copy and
verify such records.
[SEC. 506, CERTIFICATION OF DRUGS CONTAINING INSULIN,
and SEC 507, CERTIFICATION OF ANTIBIOTICS, are omitted
because of the improbability that these substances
will ever be important in toxic substances regulation.]
AUTHORITY TO DESIGNATE OFFICIAL NAMES
SEC. 508.
(a) The Secretary may designate an official name for any drug or
device if necessary or desirable in the interest of usefulness and
simplicity. Any official name shall be the only official name used in
any official compendium or for any other purpose of this Act. In no
event shall the Secretary establish an official name so as to infringe a
valid trademark.
(b) At such times as he may deem necessary, the Secretary shall
review the official names by which drugs are identified in the official
United States Pharmacopeia, the official Homeopathic Pharmacopeia of the
United States, the official National Formulary, and all supplements
thereto to determine whether revision of any of those names is necessary
or desirable in the interest of usefulness and simplicity.
-------
FD&CA - 21
(d) After each such review, the Secretary shall compile, publish,
and distribute a list of all revised official names of drugs or devices
designated under this section which list shall contain descriptive and
explanatory matter the Secretary determines to be required for the
effective use of those names.
REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES
x SEC. 510.
(a) As used in this section —
(1) "manufacture, preparation, propagation, compounding, or
processing" shall include repackaging or otherwise changing the
container, wrapper, or labeling of any drug or device package in
the distribution of the drug or device from the original place of
manufacture to the person who makes final delivery or sale to the
ultimate consumer or user...
(b) On or before December 31 of each year every person who owns or
operates any establishment engaged in the manufacture, preparation,
propagation, compounding, or processing of drugs or devices shall
register with the Secretary his name, places of business, and all such
establishments.
(c) Every person — upon first engaging in the manufacture, pre-
paration, propagation, compounding, or processing of a drug or drugs or
a device or devices in any establishment which he owns or operates —
shall immediately register with the Secretary his name, place of
business, and such establishment.
(d) Every person duly registered shall immediately register with
the Secretary any additional establishment which he owns or operates and
in which he begins manufacture, preparation, propagation, compounding,
or processing of drugs or devices.
(e) The Secretary may assign a registration number to any person
or any establishment registered in accordance with this section. The
Secretary may also assign a listing number to each drug or class of
drugs listed under subsection (j) below.
XIV (f) The Secretary shall make available for inspection any registration
filed pursuant to this section, except that any list or data submitted
pursuant to subsection (j) below shall be exempt from inspection (unless
such exemption would be inconsistent with protection of the public
health).
-------
FD&CA - 22
(g) The foregoing subsections of this section shall not apply
to —
(1) pharmacies ...
(2) practitioners licensed by law ...;
(3) persons who manufacture ... drugs or devices solely
for use in research, teaching or chemical analysis and not
for sale;
(4) such other classes of persons as the Secretary may
by regulation exempt ...
VIII (h) Every establishment registered under this section shall be
subject to inspection under section 704 [factory inspection] and every
establishment dealing with drugs or devices classified in class II or
III shall be inspected at least once in every two-year period.
(i) Any applicable establishment within any foreign country shall
be required to provide the information required by subsection (j) below.
XII (j) (1) Every person shall, at the time of registration
file with the Secretary a list of all drugs and devices which are
being manufactured, prepared, propagated, compounded, or processed
by him for commercial distribution and which he has not filed with
the Secretary before. Such list shall be prepared in such form and
manner as the Secretary may prescribe and shall be accompanied by --
(A) in the case of a drug contained in the applicable
list and subject to section 505 [new drugs] ... a reference to
the authority for the marketing of such drug or device and a
copy of all labeling for such drug or device;
(B) in the case of any other drug contained in an
applicable list —
XIII (i) which is subject to section 503(b)(l) [dispensing
prescription drugs], a copy of all labeling for such
drug, a representive sampling of advertisements for such
drug and, upon request made by the Secretary for good
cause, a copy of all advertisements for a particular drug
product, or
(ii) which drug is not subject to section 503(b)(l)
[i.e., over the counter drug], the label and package
insert for such drug or device and a representative
sampling of any other labeling for such drug or device;
-------
FD&CA - 23
(C) in the case of any prescription or non-prescription
XIII drug, a quantitative listing of its active ingredient or
ingredients, except that — with respect to a particular drug
product — the Secretary may require the submission of a
quantitative listing of all ingredients if necessary to carry
out the purposes of this Act ...
YTT
A (2) Each person who registers with the Secretary under this
subsection shall report to the Secretary once during the month of
June of each year and once during the month of December of each
year the following information:
(A) A list of each drug or device introduced by the
registrant for commercial distribution which he has not
previously filed with the Secretary. A list under this
subparagraph shall list a drug or device by its established
name (as defined in section 502(e)) and by any proprietary
name it may have and shall be accompanied by the other
information required by paragraph (1) above.
(B) If, since the date the registrant last made a report
under this paragraph, he has discontinued the manufacture,
preparation, propagation, compounding, or processing for
commercial distribution of a drug, notice of such dis-
continuance, the date of such discontinuance, and the identity
of such drug or device.
(C) If, since a notice of discontinuance, the registrant
has resumed the manufacture, preparation, propagation,
compounding, or processing for commercial distribution of a
discontinued drug, notice of such resumption, the date of such
resumption, the identity of the drug and the other information
required by paragraph (1) above ...
(D) Any material change in information previously
submitted pursuant to this paragraph or paragraph (1) above.
XII (3) The Secretary may also require each registrant under this
section to submit a list of each drug product which (A) the
registrant is manufacturing, preparing, propagating, compounding,
or processing for commercial distribution, and (B) contains a
particular ingredient.
NEW ANIMAL DRUGS
x SEC. 512.
(a) (1) A new animal drug shall be deemed unsafe for the purposes
of section 501(a)(5) and section 402(a)(2)(D) unless —
-------
FD&CA - 24
(A) there is in effect an approved application filed
pursuant to subsection (b) below with respect to its use or
intended use,
(B) the drug, its labeling, and use conform to the
approved application, and
(C) in the case of a new animal drug subject to sub-
section (n) below, it is from a batch for which a certificate
is in effect...
(2) An animal feed bearing or containing a new animal drug
shall be deemed unsafe for the purposes of section 501(a)(6)
unless —
(A) there is in effect an approved application filed
pursuant to subsection (b) below with respect to the drug, as
used in the animal feed,
(B) there is in effect an approved application pursuant
to subsection (m)(l) below with respect to such animal feed,
and
(C) the animal feed, its labeling, and use conform to
the conditions and indications of use published pursuant to
subsection (i) below and to the application approved under
subsection (m).
(3) A new animal drug or an animal feed bearing or containing
a new animal drug shall not be deemed unsafe for the purposes of
section 501(a)(5) or (6) if it is for investigational use and
conforms to the terms of an exemption in effect under section
512 (j).
(b) Any person may file with the Secretary an application with
respect to any intended use or uses of a new animal drug. Such person
I shall submit to the Secretary as a part of the application (1) full
XII reports of investigations which have been made to show whether or not
such drug is safe and effective for use; (2) a full list of the articles
used as components of such drug; (3) a full statement of the composition
of such drug; (4) a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing, and pack-
ing of such drug; (5) such samples of such drug and of the articles used
as components thereof, of any animal feed for use in or on which such
drug is intended, and of the edible portions or products (before or
after slaughter) of animals to which such drug (directly or in or on
animal feed) is intended to be administered, as the Secretary may
require; (6) specimens of the labeling proposed to be used for such drug
or in animal feed; (7) a description of practicable methods for
-------
FD&CA - 25
determining the quantity, if any, of such drug in or on food, and any
substance formed in or on food, because of its use; and (8) the proposed
tolerance or withdrawal period or other use restrictions for such drug
required in order to assure that the proposed use of such drug will be
safe.
(c) Within one hundred and eighty days after the filing of an
application pursuant to subsection (b), or such additional period as may
be agreed upon by the Secretary and the applicant, the Secretary shall
either (1) issue an order approving the application if he then finds
that none of the grounds for denying approval specified in subsection
(d) applies, or (2) give the applicant notice of an opportunity for a
hearing.
(d) (1) If the Secretary finds, after notice and hearing,
that —
(A) the investigations do not include adequate tests
by all methods reasonably applicable to show whether or not
such drug is safe for use under the conditions prescribed,
recommended, or suggested in the proposed labeling;
(B) the results of such tests show that such drug is
unsafe for use under such conditions or do not show that such
drug is safe for use under such conditions;
(C) the methods used in, and the facilities and controls
used for, the manufacture, processsing, and packing of such
drug are inadequate to preserve its identity, strength,
quality, and purity;
(D) upon the basis of the information submitted to him
as part of the application, or upon the basis of any other
information before him with respect to such drug, he has
insufficient information to determine whether such drug is
safe for use under such conditions;
(E) evaluated on the basis of the information submitted
to him as part of the application and any other information
before him with respect to such drug, there is a lack of
substantial evidence that the drug will be effective;
(F) upon the basis of the information submitted to him
as part of the application or any other information before him
with respect to such drug, the tolerance limitation proposed,
if any, exceeds that reasonably required to accomplish the
physical or other technical effect for which the drug is
intended;
(G) based on a fair evaluation of all material facts,
such labeling is false or misleading in any particular; or
-------
FD&CA - 26
(H) such drug induces cancer when ingested by man
or animal or, after tests which are appropriate for the
evaluation of the safety of such drug, induces cancer in man
or animal, except that the foregoing provisions of this
subparagraph shall not apply with respect to such drug if the
Secretary finds that, under the conditions of use specified in
proposed labeling and reasonably certain to be followed in
practice (i) such drug will not adversely affect the animals
for which it is intended, and (ii) no residue of such drug
will be found (by methods of examination prescribed or
approved by the Secretary by regulations, which regulations
shall not be subj ect to subsections (c), (d), and (h)), in any
edible portion of such animals after slaughter or in any food
yielded by or derived from the living animals;
he shall issue an order refusing to approve the application. If,
after such notice and opportunity for hearing, the Secretary finds
that subparagraphs (A) through (H) do not apply, he shall issue an
order approving the application.
(2) In determining whether such drug is safe for use under
the conditions prescribed, recommended, or suggested in the
proposed labeling thereof, the Secretary shall consider, among
other relevant factors, (A) the probable consumption of such drug
and of any substance formed in or on food because of the use of
such drug, (B) the cumulative effect on man or animal of such drug,
taking into account any chemically or pharmacologically related
substance, (C) safety factors which in the opinion of experts,
qualified by scientific training and experience to evaluate the
safety of such drugs, are appropriate for the use of animal
experimentation data, and (D) whether the conditions of use
prescribed, recommended, or suggested in the proposed labeling are
reasonably certain to be followed in practice. Any order issued
under this subsection refusing to approve an application shall
state the findings upon which it is based.
XVI (3) As used in this subsection and subsection (e),
"substantial evidence" means evidence consisting of adequate
and well-controlled investigations, including field investigation,
by experts qualified by scientific training and experience to
evaluate the effectiveness of the drug involved, on the basis of
which it could fairly and reasonably be concluded by such experts
that the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof.
IV (e) (1) The Secretary shall, after due notice and opportunity for
hearing to the applicant, issue an order withdrawing approval of a
new animal drug if he finds —
(A) that experience or scientific data show that such
drug is unsafe for use under the conditions of use upon the
basis of which application was approved;
-------
FD&CA - 27
(B) that new evidence not contained in such application
or not available to the Secretary until after such application
was approved, or tests by new methods, or tests by methods
not deemed reasonably applicable when such application was
approved, evaluated together with the evidence available to
the Secretary when the application was approved, shows that
such drug is not shown to be safe for use under the conditions
of use upon the basis of which the application was approved or
that subparagraph (H) of paragraph (1) of subsection (d)
applies to such drug;
(C) on the basis of new information before him with
respect to such drug, evaluated together with the evidence
available to him when the application was approved, that there
is a lack of substantial evidence that such drug will have the
effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
labeling thereof;
(D) that the application contains any untrue statement
of a material fact; or
(E) that the applicant has made any changes from the
standpoint of safety or effectiveness beyond the variations
provided for in the application by filing with the Secretary
adequate information respecting all such changes and unless
there is in effect an approval of the supplemental appli-
cation. The supplemental application shall be treated in the
same manner as the original application.
If the Secretary (or in his absence the officer acting as Secretary)
finds that there is an imminent hazard to the health of man or of
the animals for which such drug is intended, he may suspend the
approval of such application immediately, and give the applicant
IV prompt notice of his action and afford the applicant opportunity
for an expedited hearing under this subsection; but the authority
conferred by this sentence to suspend the approval of an application
shall not be delegated.
(2) The Secretary may also, after due notice and opportunity
for hearing to the applicant, issue an order withdrawing the
approval of an application with respect to any new animal drug
under this section if the Secretary finds —
Vi (A) that the applicant has failed to establish a system
for maintaining required records, or has repeatedly or
deliberately failed to maintain such records, or to make
required reports in accordance with a regulation or order
under subsection (1), or the applicant has refused to permit
access to, or copying or verification of, such records as
required by paragraph (2) of such subsection;
-------
FD&CA - 28
(B) that on the basis of new information before him,
evaluated together with the evidence before him when the
application was approved, the methods used in, or the facilities
" and controls used for, the manufacture, processing, and
packing of such drug are inadequate to assure and preserve its
identity, strength, quality, and purity and were not made
adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of;
or
XV (C) that on the basis of new information before him,
evaluated together with the evidence before him when the
application was approved, the labeling of such drug, based on
a fair evaluation of all material facts, is false or misleading
in any particular and was not corrected within a reasonable
time after receipt of written notice from the Secretary
specifying the matter complained of.
(3) Any order under this subsection shall state the findings
upon which it is based.
(f) Whenever the Secretary finds that the facts so require, he
shall revoke any previous order under subsection (d), (e), or (m)
refusing, withdrawing, or suspending approval of an application and
shall approve such application or reinstate such approval, as may be
appropriate...
(h) An appeal may be taken by the applicant from an order of the
Secretary refusing or withdrawing approval of an application filed under
subsection (b) or (m) of this section. The provisions of subsection (h)
of section 505 of this Act shall govern any such appeal.
(i) When a new animal drug application is approved, the Secretary
shall publish ,in the Federal Register the name and address of the
applicant and the conditions and indications of use covered by the
application, including any tolerance withdrawal period or other use
restrictions and, if such new animal drug is intended for use in animal
XV feed, appropriate purposes and conditions of use (including special
labeling requirements) applicable to any animal feed for use in which
such drug is approved, and such other information upon the basis of
which such application was approved, as the Secretary deems necessary to
assure the safe and effective use of such drug. Upon withdrawal of
approval of such new animal drug application, or upon its suspension, the
Secretary shall revoke or suspend, as the case may be, the regulation
published pursuant to this subsection insofar as it is based on the
approval of such application.
-------
FD&CA - 29
(j) To the extent consistent with the public health, the Secretary
shall promulgate regulations for exempting from the operation of this
section, new animal drugs, and animal feeds bearing or containing new
animal drugs, intended solely for investigational use by experts
qualified by scientific training and experience to investigate the
safety and effectiveness of animal drugs. Such regulations may, in the
discretion of the Secretary, among other conditions relating to the
protection of the public health, provide for conditioning such exemption
upon the establishment and maintenance of such records, and the making
of such reports to the Secretary, by the manufacturer or the sponsor of
the investigation of such article, of data (including but not limited to
analytical reports by investigators) obtained as a result of such
investigational use of such article, as the Secretary finds will enable
him to evaluate the safety and effectiveness of such article in the
event of the filing of an application pursuant to this section...
VI (1) (1) In the case of any new animal drug for which an approval
XII of an application filed pursuant to subsection (b) is in effect,
the applicant shall establish and maintain such records, and make
such reports to the Secretary, of data relating to experience and
other data or information, received or otherwise obtained by such
XIII applicant with respect to such drug,' or with respect to animal
feeds bearing or containing such drug, as the Secretary may by
general regulation, or by order with respect to such application,
prescribe... Such regulation or order shall provide, where the
Secretary deems it to be appropriate, for the examination, upon
request, by the persons to whom such regulation or order is
applicable, of similar information received or otherwise obtained
by the Secretary.
VIII (2) Every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall, upon
request of an officer or employee designated by the Secretary,
permit such officer or employee at all reasonable times to have
access to and copy and verify such records.
XII (m) (1) Any person may file with the Secretary an application
V with respect to any intended use or uses of an animal feed bearing
XV or containing a new animal drug. The applicant shall submit (A) a
full statement of the composition of such animal feed; (B) an
identification of the regulation or regulations relating to the new
animal drug or drugs to be used in such feed on which the application
relies; (C) a full description of the methods used in, and the
facilities and controls used for, the manufacture, processing, and
packing of such animal feed; (D) specimens of the labeling proposed
to be used for such animal feed; and (E) if so requested by the
Secretary, samples of such animal feed or its components.
-------
FD&CA - 30
(2) Within ninety days after the filing of an application to
subsection (m) (1) , or such additional period as may be agreed upon
by the Secretary and the applicant, the Secretary shall either (A)
issue an order approving the application if he then finds that none
of the grounds for denying approval specified in paragraph (3)
IV applies, or (B) give the applicant notice of an opportunity for a
hearing.
(3) If the Secretary, after due notice to the applicant in
accordance with paragraph (2) and giving him an opportunity for a
hearing in accordance with such paragraph, finds, on the basis of
information submitted to him as part of the application or on the
basis of any other information before him —
(A) that there is not in effect a regulation on the
basis of which such application may be approved;
(B) that such animal feed (including the proposed use of
any new animal drug therein or thereon) does not conform to an
applicable regulation published pursuant to subsection (i)
referred to in the application, or that the purposes and
conditions or indications or use prescribed, recommended, or
suggested in the labeling of such feed do not conform to the
applicable purposes and conditons or indications of use
(including warnings) published pursuant to subsection (i) or
such labeling omits or fails to conform to other applicable
information published pursuant to subsection (i) ;
(C) that the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of
such animal feed are inadequate to preserve the identity,
strength, quality, and purity of the new animal drug therein;
or
XV (D) that, based on a fair evaluation of all material
facts, such labeling is false or misleading in any particular;
he shall issue an order refusing to approve the application. If,
after such notice and opportunity for hearing, the Secretary finds
that subparagraphs (A) through (D) do not apply, he shall issue an
order approving the application.
(4) (A) The Secretary shall, after due notice and opportunity
for hearing to the applicant, issue an order withdrawing
approval of an application with respect to any animal feed
under this subsection if the Secretary finds —
(i) that the application contains any untrue
statement of a material fact; or
-------
FD&CA - 31
(ii) that the applicant has made any changes from
the standpoint of safety or effectiveness beyond the
variations provided for in the application unless he has
supplemented the application by filing with the Secretary
adequate information respecting all such changes and
unless there is in effect an approval of the supplemental
application. The supplemental application shall be treated
in the same manner as the original application.
(B) The Secretary may also, after due notice and
opportunity for hearing to the applicant, issue an order
withdrawing the approval of an application with respect to any
animal feed under this subsection if the Secretary finds —
(i) that the applicant has failed to establish a
system for maintaining required records, or has repeatedly
or deliberately failed to maintain such records or to
make required reports in accordance with a regulation or
order under paragraph (5) (A) of this subsection, or the
applicant has refused to permit access to, or copying or
verification of, such records;
(ii) that on the basis of new information before
him, evaluated together with the evidence before him when
such application was approved, the methods used in, or
the facilities and controls used for, the manufacture,
processing, and packing of such animal feed are
inadequate to assure and preserve the identity, strength,
quality, and purity of the new animal drug therein, and
were not made adequate within a reasonable time after
receipt of written notice from the Secretary specifying
the matter complained of; or
(iii) that on the basis of new information before
him, evaluated together with the evidence before him when
the application was approved, the labeling of such animal
feed, based on a fair evaluation of all material facts,
is false or misleading in any particular and was not
corrected within a reasonable time after receipt of
written notice from the Secretary specifying the matter
complained of.
(C) Any order under paragraph (4) of this subection
shall state the findings upon which it is based.
(5) In the case of any animal feed for which an approval of
an application filed pursuant to this subsection is in effect —
-------
FD&CA - 32
(A) the applicant shall establish and maintain such
records, and reports to the Secretary, or (at the option of
XIII the Secretary) to the appropriate person or persons holding an
approved application filed under subsection (b), as the
Secretary may by general regulation, or by order with respect
to such application, prescribe ...
(B) every person required under this subsection to
VIII maintain records, and every person in charge or custody
thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee
at all reasonable times to have access to and copy and verify
such records.
CHAPTER VI — COSMETICS
ADULTERATED COSMETICS
XVI SEC. 601.
A cosmetic shall be deemed to be adulterated —
(a) If it bears or contains any poisonous or deleterious substance
which may render it injurious to users under the conditions of use as
are customary or usual; Provided, that this provision shall not apply
to coal-tar hair dye, the label of which bears the following legend
XV conspicuously displayed thereon: "Caution — This product contains
ingredients which may cause skin irritation on certain individuals and a
preliminary test according to accompanying directions should first be
made. This product must not be used for dying the eyelashes or eyebrows;
to do so may cause blindness.", and the labeling of which bears adequate
directions for such preliminary testing. For the purposes of this
paragraph and paragraph (e) the term "hair dye" shall not include
eyelash dyes or eyebrow dyes.
(b) If it consists in whole or in part of any filthy, putrid, or
decomposed substance.
(c) If it has been prepared, packed, or held under unsanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health.
(d) If its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health.
-------
FD&CA - 33
(e) If it is not a hair dye, and it is, or it bears or contains, a
color additive which is unsafe within the meaning of section 706(a).
MISBRANDED COSMETICS
SEC. 602.
A cosmetic shall be deemed to be misbranded —
(a) If its labeling is false or misleading in any particular.
(b) If in package form, unless it bears a label containing (1) the
name and place of business of the manufacturer, packer, or distributor;
and (2) an accurate statement of the quantity of the contents in terms
of weight, measure, or numerical count; Provided, that under clause (2)
of this paragraph reasonable variations shall be permitted, and exemptions
as to small packages shall be established, by regulations prescribed by
the Secretary.
(c) If any word, statement, or other information required by or
under authority of this Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with
other words, statements, designs, or devices in the labeling) and in
such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.
(d) If its container is so made, formed, or filled as to be
misleading.
(e) If it is a color additive, unless its packaging and labeling
are in conformity with such packaging and labeling requirements,
applicable to such color additive, as may be contained in regulations
issued under section 706. This paragraph shall not apply to packages of
color additives which, with respect to their use for cosmetics, are
marketed and intended for use only in or on hair dyes (as defined in the
last sentence of section 601(a)).
(f) If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 3 or 4 of the Poison Prevention
Packaging Act of 1970.
REGULATIONS MAKING EXEMPTIONS
XVII SEC. 603.
The Secretary shall promulgate regulations exempting from any
labeling requirement of this Act cosmetics which are, in accordance with
-------
FD&CA - 34
the practice of the trade, to be processed, labeled, or repacked in
substantial quantities at establishments other than those where
originally processed or packed, on condition that such cosmetics
are not adulterated or misbranded under the provisions of this Act upon
removal from such processing, labeling, or repacking establishment.
CHAPTER VII — GENERAL
ADMINISTRATIVE PROVISIONS
REGULATIONS AND HEARINGS
XV SEC. 701.
II
(a) The authority to promulgate regulations for the efficient
VI enforcement of this Act, except as otherwise provided in this section,
is hereby vested in the Secretary.
(b) The Secretary of the Treasury and the Secretary of Health,
Education, and Welfare shall jointly prescribe regulations for the
efficient enforcement of the provisions of section 801 [import and
export drugs and devices] except as otherwise provided therein...
(e) (1) Any action for the issuance, amendment, or repeal of
any regulation under section 401 [Definitions and Standards
for Food], 403(j) [dietary food labels], 404(a) [Emergency
Permit Control], 406 [Tolerances for Poisonous Ingredients in
Food], 501(b) [drug quality control tests] or 502(d) [designation
of habit-forming drugs], or 502(h) [drugs liable to deterioration
labeling] shall begin by a proposal made by the Secretary or
by petition of any interested persons...
EXAMINATIONS AND INVESTIGATIONS
II SEC. 702.
(a) The Secretary is authorized to conduct examinations and
investigations for the purposes of this Act through officers and
employees of the Department or through any health, food, or drug officer
or employee of any State, Territory, or political subdivision thereof,
duly commissioned by the Secretary as an officer of the Department...
-------
FD&CA - 35
III (c) For purposes of enforcement of this Act, records of any
department or independent establishment in the Executive Branch of the
Government shall be open to inspection by any official of the Department
of Health, Education, and Welfare duly authorized by the Secretary to
make such inspection.
(d) The Secretary is authorized and directed, upon request from
the Commissioner of Patents, to furnish full and complete information
III with respect to such questions relating to drugs as the Commissioner may
II submit concerning any patent application. The Secretary is further
authorized, upon receipt of any such request, to conduct or cause to be
conducted, such research as may be required.
VIII (e) Any officer or employee of the Department designated by the
Secretary to conduct examinations, investigations, or inspections under
this Act relating to counterfeit drugs may, when so authorized by the
Secretary — ...
(2) execute and serve search warrants...
RECORDS OF INTERSTATE SHIPMENT
SEC. 703.
VIII For the purpose of enforcing the provisions of this Act, carriers
engaged in interstate commerce, and persons receiving or holding food,
drugs, devices, or cosmetics in interstate commerce shall at reasonable
times, upon the request of an officer designated by the Secretary,
permit access to and copying of all records showing the movement in
interstate commerce of any food, drug, device, or cosmetic, and the
quantity, shipper, and consignee thereof; and it shall be unlawful to
fail to permit such access and copying ...
FACTORY INSPECTION
VIII SEC. 704.
(a) For purposes of enforcement of this Act, officers duly
designated by the Secretary, upon presenting appropriate credentials and
a written notice are authorized (1) to enter, at reasonable times, any
-------
FD&CA - 36
factory, warehouse, or establishment in which food, drugs, devices, or
cosmetics are manufactured, processed, packed, or held or to enter any
vehicle used to transport or hold such items; and (2) to inspect, in a
reasonable manner, such factory, warehouse, establishment, or vehicle
and all pertinent equipment, finished and unfinished materials, containers,
and labeling therein. In the case of any factory, warehouse, establish-
ment, or consulting laboratory in which prescription drugs or restricted
devices are manufactured, processed, packed, or held, inspection shall
extend to all things therein (including records, files, papers,
processes, controls, and facilities). No inspection shall extend to
financial data, sales data other than shipment data, pricing data,
personnel data and research data, other than data relating to new drugs,
antibiotic drugs, and devices and subject to reporting and inspection
under regulations lawfully issued pursuant to this Act...
PUBLICITY
SEC. 705..
(b) The Secretary may also cause to be disseminated information
regarding food, drugs, devices, or cosmetics in situations involving
imminent danger to health, or gross deception of the consumer. Nothing
in this section shall be construed to prohibit the Secretary from
collecting, reporting, and illustrating the results of the investigations
of the Department.
LISTING AND CERTIFICATION OF COLOR ADDITIVES
FOR FOODS, DRUGS, AND COSMETICS
WHEN COLOR ADDITIVES DEEMED UNSAFE
X SEC. 706.
(a) A color additive shall, with respect to any particular use
(actual, intended or represented as suitable for, in, or on food or
drugs or devices or cosmetics) be deemed unsafe (for the purposes of the
application of section 402(c), section 501(a)(4), or section 601(e), as
the case may be) unless —
(1) (A) the additive is listed in accordance with subsection
(b) below and the additive and use conform with any provisions
of that listing, and (B) the additive is from a certified
batch if batch certification is required under subsection (c)
below ...
-------
FD&CA - 37
LISTING OF COLORS
(b) (1) The Secretary shall, by regulation, provide for separately
listing of color additives for use in or on food, drugs or devices,
and cosmetics, if the additives are suitable and safe for such uses.
(2) (A) Any color additive may be listed for use generally
in or on food, drugs or devices, or cosmetics...
(B) Any additive may be listed only for uses for
which the available data established that is suitable and
may safely be employed.
(3) Such regulations shall prescribe conditions under which
the additive may be safely employed, including, but not limited
to maximum quantities which may be used or permitted to remain in
or on articles in or on which it is used; the manner in which such
additive may be added to or used in or on such article or articles;
and directions or other labeling or packaging requirements.
(4) The Secretary shall not list a color additive unless the
data before him establish that under-the conditions specified, the
additive will be safe: Provided, however, that a color additive
shall be deemed to be suitable and safe for use generally in or on
food if it is generally recognized by qualified experts as safe
intended use, as provided in section 201(s).
II (5) (A) In determining, for the purposes of this section,
whether a proposed use of a color additive is safe, the
Secretary shall consider among other relevant factors —
(i) the probable consumption of, or other relevant
exposure from, the additive and of any substance formed
in or on food, drugs or devices, or cosmetics because of
the use of the additive;
(il) the cumulative effect, if any, of such additive
in the diet of man or animals, taking into account the
same or any chemically or pharmacologically related
substance or substances in such diet;
(iii) safety factors which, in the opinion of
experts qualified by scientific training and experience
to evaluate the safety of color additives, are generally
recognized as appropriate for the use of animal
experimentation data; and
(iv) the availability of any needed practicable
methods of analysis for determining the identity and
quantity of (I) the pure dye and all intermediates and
-------
FD&CA - 38
other Impurities contained in such color additive, (II)
such additive in or on any article of food, drug or
devices, or cosmetic, and (III) any substance formed in
or on such article because of the use of such additive.
(B) A color additive (i) shall be deemed unsafe, and
shall not be listed, for any use which will or may result in
ingestion of all or part of the additive, if it is found by
the Secretary to induce cancer when ingested in appropriate
tests...;
(C) (i) In any proceeding for the issuance, amendment,
or repeal of a regulation listing a color additive, any
person who will be adversely affected by the proposal or
by the Secretary's order may request that the petition or
IV order be referred to an advisory committee for a report
and recommendations with respect to any matter arising
under subparagraph (B) above;
(ii) Within sixty days (or ninety days if extended)
the committee shall, after independent study of the data
furnished to it by the Secretary and other data before
it, certify a report and recommendations, together with
all underlying data and a statement of the reasons or
basis for the recommendations. A copy of the report
shall be promptly supplied to any person who has filed a
petition, or who has requested referral to the advisory
committee. Within thirty days after that, the Secretary
shall act upon the petition or other proposal...
(7) If, in the judgment of the Secretary, a tolerance
•*• limitation is required in order to assure that a proposed use of a
color additive will be safe, the Secretary —
(A) shall not list the additive for such use if he finds
that the data before him do not establish that such additive,
if used within a safe tolerance limitation, would achieve the
intended physical or other technical effect; and
(B) shall not fix such tolerance limitation at a level
higher than he finds to be reasonably required to accomplish
the intended physical or other technical effect.
CERTIFICATION OF COLORS
(c) The Secretary shall further, by regulation, provide (1) for
the certification, with safe diluents or without diluents, of batches of
color additives listed pursuant to subsection (b) above and (2) for
-------
FD&CA - 39
exemption from the requirement of certification which he finds not
to be necessary in the interest of the protection of the public
health: Provided, that for GRAS substances batch certification shall
be deemed not necessary.
REVISION OF UNITED STATES PHARMACOPEIA:
DEVELOPMENT OF ANALYSIS AND MECHANICAL
AND PHYSICAL TESTS
[21 U.S.C. 377 — Section 201 of the Labor-Federal Security
Appropriation Act, 1944]
The Secretary, in carrying into effect the provisions of this
chapter, is authorized hereafter to cooperate with associations and
scientific societies in the revision of the United States Pharmacopeia
and in the development of methods and analyses and mechanical and
physical tests necessary to carry out the work of the Food and Drug
Administration.
CONFIDENTIAL INFORMATION
XIV SEC. 708.
The Secretary may provide any information which is exempt from
disclosure (pursuant to subsection (a) of section 552 of Title 5, United
States Code, by reason of subsection (b)(4) of such section) to a
person other than an officer or employee of the Department if he
determines such other person requires the information in connection with
an activity undertaken for the Secretary, in which the Secretary is not
prohibited from using such information. The Secretary shall require
that the person receiving the information take security precautions
respecting the information the Secretary prescribes.
CHAPTER VIII — IMPORTS AND EXPORTS
YTTTT SEC. 801.
(a) The Secretary of the Treasury shall deliver to the,Secretary
of Health, Education, and Welfare, upon his request, samples of food,
-------
FD&CA - 40
drugs, devices, and cosmetics which are being imported or offered for
import into the United States, giving notice thereof to the owner or
consignee, who may appear before the Secretary of Health, Education, and
Welfare and have the right to introduce testimony ... If it appears from
the examination of such samples or otherwise that (1) such article has
been manufactured, processed, or packed under unsanitary conditions, or
(2) such article is forbidden or restricted in sale in the country in
which it was produced or from which it was exported, or (3) such article
is adulterated, or misbranded then such article shall be refused
admission...
(b) ... If it appears to the Secretary of Health, Education and
Welfare that an article included within the provisions of clause (3) of
subsection (a) above, by relabeling or other action can be brought into
compliance with the Act, final determination as to admission of such
article may be deferred — the Secretary may authorize the applicant to
perform such relabeling or other action...
(d) (1) A food, drug, device, or cosmetic intended for export
shall not be deemed to be adulterated or misbranded under this
Act if it --
(A) accords to the specifications of the foreign
purchaser;
(B) is not in conflict with the laws of the country to
which it is intended for export;
(C) is labeled on the outside of the shipping package
that it is intended for export; and
(D) is not sold or offered for sale in domestic
commerce.
-------
PUBLIC LAW 91-596 — December 29, 1970
"OCCUPATIONAL SAFETY AND HEALTH ACT"
CONGRESSIONAL FINDINGS AND PURPOSE
SEC. 2. . •
XV11 (b) The Congress declares it to be its purpose and policy to
assure so far as possible every working man and woman in the Nation safe
and healthful working conditions — ...
(5) by providing for research in the field of occupational
safety and health, including the psychological factors involved,
and by developing innovative methods, techniques, and approaches
for dealing with occupational safety and health problems;
(6) by exploring ways to discover latent diseases, establishing
causal connections between diseases and work in environmental
conditions, and conducting other research relating to health
problems, in recognition of the fact that occupational health
standards present problems often different from those involved in
occupational safety;
(7) by providing medical criteria which will assure insofar
as practicable that no employee will suffer diminished health,
functional capacity, or life expectancy as a result of his work
experience;...
(9) by providing for the development and promulgation of'
occupational safety and health standards;...
(12) by providing for appropriate reporting procedures with
respect to occupational safety and health that will help achieve
the objectives of this Act and accurately describe the nature of
the occupational safety and health problem;...
DEFINITIONS
SEC. 3.
For the purposes of this Act:
XVI (1) "Secretary" means the Secretary of Labor...
-------
OSHA - 2
XVI (O "Occupational safety and health standard" means a
standard which requires conditions, or the adoption or use of one
or more practices, means, methods, operations, or processes,
reasonably necessary or appropriate to provide safe or healthful
employment and places of employment.
(9) "National consensus standard" means any occupational
safety and health standard or modification thereof which (1) has
been adopted and promulgated by a nationally recognized standards-
producing organization under procedures whereby it can be determined
by the Secretary that persons interested and affected by the scope
or provisions of the standard have reached substantial agreement on
its adoption, (2) was formulated in a manner which afforded the
opportunity for diverse views to be considered and (3) has been
designated as such a standard by the Secretary, after consultation
with other appropriate Federal agencies.
XVI (10) "Established Federal standard" means any operative
occupational safety and health standard established by any agency
of the United States and presently in effect, or contained in any
Act of Congress in force on the date of enactment of this Act.
XVI (11) "Committee" means the National Advisory Committee on
Occupational Safety and Health established under this Act.
XVI (12) "Director" means the Director of the National Institute
for Occupational Safety and Health.
XVI (13) "Institute" means the National Institute for Occupational
Safety and Health established under this Act...
APPLICABILITY OF THIS ACT
SEC. 4...
II (b) (3) The Secretary shall [before May 1974] report to Congress
his recommendations for legislation to avoid unnecessary duplication
and to achieve coordination between this Act and other Federal
laws.
OCCUPATIONAL SAFETY AND HEALTH STANDARDS
II SEC. 6...
(b) The Secretary may by rule promulgate, modify, or revoke any
occupational safety or health standard in the following manner:
-------
OSHA - 3
(1) Whenever the Secretary, on the basis of information
available to him, determines that a rule should be promulgated, he
may request the recommendations of an advisory committee appointed
IV under section 7 below. He shall provide the advisory committee
with any proposals together with all pertinent information,
including the results of research, demonstrations, and experiments.
The advisory committee shall submit its recommendations...
(5) The Secretary, in promulgating standards dealing with
toxic materials or harmful physical agents, shall set the standard
which most adequately assures, to the extent feasible, that no
employee will suffer material impairment of health or functional
capacity even if regularly exposed to the hazard for the period of
his working life. Standards shall be based upon research,
demonstrations, experiments, and other appropriate information. In
addition to attainment of the highest degree of health and safety
protection for the employee, other considerations shall be the
latest available scientific data in the field, the feasibility of
the standards, and experience gained under this and other health
and safety laws. Whenever practicable, the standard promulgated
shall be expressed in terms of objective criteria and of the
performance desired...
XV (7) Any standard shall prescribe the use of labels or other
appropriate forms of warning necessary to insure that employees are
apprised of all hazards to which they are exposed, relevant
symptoms and appropriate emergency treatment, and proper conditions
and precautions of safe use or exposure. Where appropriate, such
standard shall also prescribe suitable protective equipment and
control or technological procedures to be used in connection with
^ such hazards and shall provide for monitoring or measuring employee
exposure at such locations and intervals, and in such manner as may
be necessary for the protection of employess [see subsection 8(c)].
In addition, where appropriate, any such standard shall prescribe
I v th® type and frequency of medical examinations or other tests which
shall be made available to employees in order to most effectively
determine whether their health is adversely affected by such
exposure. In the event such medical examinations are in the nature
II of research, such examinations may be furnished at the expense of
the Department of Health, Education, and Welfare. The results of
XIV such examinations or tests shall be furnished only to the Secretary
or the Secretary of Health, Education, and Welfare, and, at. the
request of the employee, to his physician...
X (d) Any affected employer may apply to the Secretary for a
variance from a standard. Affected employees shall be given notice of
each such application and an opportunity to participate in a hearing.
IV The Secretary shall grant a variance if he determines that the applicant
has demonstrated, by a preponderance of the evidence, that the
conditions, practices, means, methods, operations, or processes proposed
to be used will provide safe and healthful employment. The variance
shall prescribe the conditions the employer must maintain, and the
practices, means, methods, operations, and processes which he must adopt
and utilize...
-------
OSHA - 4
ADVISORY COMMITTEES; ADMINISTRATION
IV SEC. 7.
(a) (1) There is hereby established a National Advisory Committee
on Occupational Safety and Health consisting of twelve members
composed of representatives of management, labor, occupational
safety and occupational health professions, and of the public. The
members shall be selected upon the basis of their experience and
competence in the field of occupational safety and health.
(2) The Committee shall advise, consult with, and make
recommendations to the Secretary and the Secretary of Health,
Education, and Welfare on matters relating to the administration of
the Act. The Committee shall hold no fewer than two meetings
during each calendar year. All meetings of the Committee shall be
opened to the public and a transcript shall be kept and made
available for public inspection.
(b) An advisory committee may be appointed by the Secretary to
assist him in his standard-setting functions under section 6 of this
Act. Each such committee shall consist of not more than fifteen members
and shall include representation for HEW, management, labor, and State
health agencies.
(c) In carrying out his responsibilities under this Act, the
Secretary is authorized to —
HI (!) use, with the consent of any Federal agency, the
services, facilities, and personnel of such agency, with or without
reimbursement, and with the consent of any State or political
subdivision thereof, accept and use the services, facilities, and
personnel of any agency of such State or subdivision with
reimbursement; and
(2) employ experts and consultants or organizations thereof
as authorized by section 3109 of Title 5, United States Code.
INSPECTIONS, INVESTIGATIONS, AND RECORD-KEEPING
SEC. 8.
VIII (a) In order to carry out the purposes of this Act, the Secretary,
upon presenting appropriate credentials to the owner, operator, or
agent in charge, is authorized —
-------
OSHA - 5
(1) to enter without delay and at reasonable times any
factory, plant, establishment, construction site, or other area,
workplace or environment where work is performed by an employee;
and
(2) to inspect and investigate within reasonable limits and
in a reasonable manner, any such place of employment and all
pertinent conditions, structures, machines, apparatus, devices,
equipment, and materials therein, and to question privately any
such employer, owner, operator, agent or employee.
IX (b) In making his inspections and investigations under this Act
the Secretary may require (by force of court order if necessary) the
attendance and testimony of witnesses and the production of evidence
under oath.
Vii (c) (1) Each employer shall make, keep and preserve, and make
VIII available to the Secretary or the Secretary of Health, Education,
and Welfare, such records regarding his activities relating to this
Act as the Secretary, in cooperation with the Secretary of Health,
Education, and Welfare, may prescribe by regulation as .necessary
for the effective enforcement of this Act for developing infor-
mation regarding the causes and prevention of occupational
VIII accidents and illnesses. Such regulation may include provisions
requiring periodic inspections. The Secretary shall also issue
regulations requiring that employers, through posting of notices or
XV other appropriate means, keep their employees informed of their
protections and obligations under this Act, including the pro-
visions of applicable standards.
Vi (2) The Secretary, in cooperation with the Secretary of
Xii Health, Education, and Welfare, shall prescribe regulations
requiring employers to maintain accurate records of, and to make
periodic reports on, work-related deaths, injuries and illnesses
other than minor injuries...
HI (3) The Secretary, in cooperation with the Secretary of
Health, Education, and Welfare, shall issue regulations requiring
Vi employers to maintain accurate records of employee exposures to
potentially toxic materials or harmful physical agents which are
V required to be monitored or measured under section 6. Such
regulations shall provide employees or their representatives an
opportunity to observe such monitoring or measuring, and to have
access to the records thereof. Each employer shall promptly notify
any employee who has been or is being exposed to toxic materials or
harmful physical agents in concentrations or at levels which exceed
those prescribed by an applicable occupational safety and health
standard, and shall inform him of the corrective action being
taken.
-------
OSHA - 6
(d) Any information obtained under this Act shall be obtained with
a minimum burden upon employers, especially those operating small
businesses. Unnecessary duplication of efforts in obtaining information
shall be reduced to the maximum extent feasible...
VIII (f) (1) Any employee or representative of employees who believes
that a violation of a standard exists or that an imminent danger
exists, may request an inspection by the Secretary. Any request
shall be reduced to writing, and shall set forth with reasonable
particularity the grounds for the request. If the Secretary
determines there are reasonable grounds he shall make a special
inspection as soon as practicable, to determine if such violation
or danger exists...
XIV (g) (1) The Secretary and the Secretary of Health, Education, and
Welfare are authorized to compile, analyze, and publish, either in
summary or detailed form, all reports or information obtained under
this section.
VIII (2) The Secretary and the Secretary of Health, Education, and
Welfare shall each prescribe such rules and regulations as he may
deem necessary to carry out their responsibilities under this Act,
VIII including rules and regulations dealing with the inspection of an
employer's establishment.
CONFIDENTIALITY OF TRADE SECRETS
XIV SEC. 15.
All information reported to or obtained by the Secretary in
connection with any inspection or proceeding under this Act which
contains or which might reveal a trade secret shall be considered
confidential, except that such information may be disclosed to other
officers or employees concerned with carrying out this Act or when
relevant in any proceeding under this Act. In any such proceeding the
Secretary... or the court shall issue such orders as may be appropriate
to protect the confidentiality of trade secrets.
STATE JURISDICTION AND STATE PLANS
XVII SEC. 18...
(c) The Secretary shall approve the plan submitted by a State if
such plan in his judgment —...
-------
OSHA - 7
VIII (3) provides for a right of entry and inspection of all
workplaces subject to the Act which is at least as effective as
that provided in section 8, and includes a prohibition on advance
notice of inspections;...
XII (7) requires employers in the State to make reports to the
Secretary in the same manner and to the same extent as if the plan
were not in effect; and
YTT
(8) provides that the State agency will make such reports to
the Secretary in such form and containing such information, as the
Secretary shall from time to time require.
RESEARCH AND RELATED ACTIVITIES
II SEC. 20.
Ill
(a) (1) The Secretary of Health, Education, and Welfare, after
consultation with appropriate Federal departments or agencies shall
conduct (directly or by grants or contracts) research, experiments,
and demonstrations relating to occupational safety and health,
including studies of psychological factors involved, and relative
to innovative methods, techniques, and approaches for dealing with
occupational safety and health problems.
(2) The Secretary of Health, Education, and Welfare, shall
consult with the Secretary in order to develop specific plans for
such research, demonstrations, and experiments as are necessary to
produce criteria, including criteria identifying toxic substances,
enabling the Secretary to meet his responsibility for the formulation
of safety and health standards under this Act; and the Secretary of
Health, Education, and Welfare, on the basis of such research,
demonstrations, and experiments and any other information available
to him, shall develop and publish at least annually such criteria
as will effectuate the purposes of this Act.
(3) The Secretary of Health, Education, and Welfare, on the
basis of research, demonstrations, and experiments, and any other
information available shall develop criteria dealing with toxic
materials and harmful physical agents and substances which will
describe exposure levels that are safe for various periods of
employment, including but not limited to the exposure levels at
which no employee will suffer impaired health or functional
capacities or diminished life expectancy as a result of his work
experience.
-------
OSHA - 8
(4) The Secretary of Health, Education, and Welfare shall
also conduct special research, experiments, and demonstrations
relating to occupational safety and health as are necessary to
explore new problems, including those created by new technology in
occupational safety and health, which may require ameliorative
action beyond that which is otherwise provided for in the operating
provisions of this Act...
V (5) The Secretary of Health, Education, and Welfare, in order
VI to comply with his responsibilities under paragraph (2) above, and
XII in order to develop needed information regarding potentially toxic
substances or harmful physical agents, may prescribe regulations
requiring employers to measure, record, and make reports on the
exposure of employees to substances or physical agents which the
Secretary of Health, Education, and Welfare reasonably believes may
endanger the health or safety of employees. The Secretary of
Health, Education, and Welfare also is authorized to establish such
I programs of medical examinations and tests as may be necessary for
V determining the incidence of occupational illnesses and the
susceptibility of employees to such illnesses. Upon the request of
XVII any employer who is required to measure and record exposure of
employees to substances or physical agents, the Secretary of
Health, Education, and Welfare shall furnish full financial or
other assistance to such employer for the purpose of defraying any
additional expense incurred by him.
II (6) The Secretary of Health, Education, and Welfare shall
publish, at least annually, a list of all known toxic substances by
generic family or other useful grouping, and the concentrations at
which such toxicity is known to occur. He shall determine,
following a written request by any employer or authorized
representative of employees, specifying with reasonable particularity
the grounds on which the request is made, whether any substance
normally found in the place of employment has potentially toxic
effects in such concentrations as used or found; and shall submit
such determination both to employers and affected employees as soon
as possible. If the Secretary of Health, Education, and Welfare
determines that any substance is potentially toxic at the con-
centrations in which it is used or found in a place of employment,
and such substance is not covered by an occupational safety or
health standard promulgated under section 6, the Secretary of
Health, Education, and Welfare shall immediately submit such
determination to the Secretary, together with all pertinent
criteria.
(7) Annually, the Secretary of Health, Education, and Welfare
shall conduct and publish industrywide studies of the effect of
chronic or low-level exposure to industrial materials, processes,
and stresses on the potential for illnesses, disease, or loss of
functional capacity in aging adults.
-------
OSHA - 9
(b) The Secretary of Health, Education, and Welfare is authorized
to make inspections and question employers and employees as provided in
VIII section 8 of this Act in order to carry out his functions and respons-
ibilities under this section.
(c) The Secretary is authorized to enter into contracts, agree-
ments or other arrangements with appropriate public agencies or private
organizations for the purpose of conducting studies relating to his
responsibilities under this Act. In carrying out his responsibilities
under this subsection, the Secretary shall cooperate with the Secretary
of Health, Education, and Welfare in order to avoid duplication of
efforts.
XVII (e) The functions of the Secretary of Health, Education, and
Welfare under this Act shall, to the extent feasible, be delegated to
the Director of the National Institute for Occupational Safety and
Health established by section 22 below.
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY
AND HEALTH
IV SEC. 22.
II (a) It is the purpose of this section to establish a National
Institute for Occupational Safety and Health in the Department of
Health, Education, and Welfare in order to carry out the policy set
forth in section 2 of this Act and to perform the functions of the
Secretary of Health, Education, and Welfare under sections 20 and 21 of
this Act...
(c) The Institute is authorized to —
(1) develop and establish recommended occupational safety and
health standards...
(d) Upon his own initiative, or upon the request of the Secretary
of Health, Education, and Welfare, the Director is authorized (1) to
conduct such research and experimental programs as he determines are
necessary for the development of criteria for new and improved occu-
pational safety and health standards, and (2) after consideration of
the results of such research and experimental programs make recom-
mendations concerning new or improved occupational safety and health
standards. Any occupational safety and health standard recommended
pursuant to this section shall immediately be forwarded to the Secretary
of Labor, and to the Secretary for Health, Education, and Welfare.
-------
OSHA - 10
(e) In addition to any authority vested in the Institute by the
other provisions of this section, the Director, in carrying out the
functions of the Institute, is authorized to —...
(5) obtain the services of experts and consultants in
accordance with the provisions of section 3109 of title 5,
United States Code;...
STATISTICS
II SEC. 24.
(a) In order to further the purposes of this Act, the Secretary,
III in consultation with the Secretary of Health, Education, and Welfare,
shall develop and maintain an effective program of collection, com-
pilation, and analysis of occupational safety and health statistics.
Such program may cover all employments whether or not subject to any
other provisions of this Act but shall not cover employments excluded by
section 4. The Secretary shall compile accurate statistics on work
injuries and illnesses which shall include all disabling, serious, or
significant injuries and illnesses, whether or not involving loss of
time from work, other than minor injuries...
(b) To carry out his duties under subsection (a) above, the
Secretary may —
(1) promote, encourage, or directly engage in programs of
studies, information and communication concerning occupational
safety and health statistics;
(2) make grants to States in order to assist them in
developing and administering programs dealing with occupational
safety and health statistics; and
(3) arrange, through grants or contracts, for the conduct of
such research and investigations which further the objectives of
this section...
(e) On the basis of the records made and kept pursuant to section
8(c) of this Act, employers shall file such reports with the Secretary
as he shall prescribe by regulation, as necessary to carry out his
functions under this Act.
-------
XVI
PUBLIC LAW 91-173 — 1969
as amended by
PUBLIC LAW 95-164 — November 9, 1977
FEDERAL MINE SAFETY AND HEALTH ACT of 1977
* * *
DEFINITIONS
SEC. 3.
For the purpose of this Act:
(a) "Secretary" means the Secretary of Labor or his delegate;...
(j) "Imminent danger" means the existence of any condition or
practice in a coal or other mine which could reasonably be expected to
cause death or serious physical harm before such condition or practice
can be abated;
(k) "Accident" includes..., or injury to, or death of, any person;
(1) "Mandatory health or safety standard" means the interim
mandatory health or safety standards established by Titles II and III of
this Act, and the standards promulgated pursuant to Title I of this Act;
(n) "Administration" means the Mine Safety and Health Admin-
istration in the Department of Labor...
TITLE I — GENERAL
MANDATORY SAFETY AND HEALTH STANDARDS
SEC. 101.
(a) The Secretary shall by rule develop, promulgate, and revise
as appropriate, improved mandatory health or safety standards for the
protection of life and prevention of injuries in mines.
-------
FMSHA - 2
IV (1) Whenever the Secretary determines that a rule should
be promulgated in order to serve the objectives of this Act,
he may request the recommendation of an advisory committee
appointed under section 102(c) below. The Secretary shall
provide such advisory committee with any proposals of his own
or of the Secretary of Health, Education, and Welfare, together
with all pertinent factual information available, including
the results of research, demonstrations, and experiments. The
advisory committee shall submit its recommendations regarding
the rule to be promulgated within 60 days or within such longer
or shorter period as may be prescribed by the Secretary, but in
no event longer than 180 days...
IV (3) ...Any hearing in connection with promulgating a mandatory
safety or health standard for the purpose of hearing relevant
information shall commence within 60 days. The Secretary may
IX require by subpoena the attendance of witnesses and the production
of evidence in connection with any proceeding initiated under this
section...
II (6) (A) The Secretary, in promulgating mandatory standards
dealing with toxic materials or harmful physical agents, shall
set standards which most adequately assure (on the basis of
the best available evidence) that no miner will suffer
material impairment of health or functional capacity even if
such miner has regular exposure to the hazards for the period
of his working life. Development of mandatory standards shall
be based upon research, demonstrations, experiments, and such
other information as may be appropriate. In addition to the
attainment of the highest degree of health and safety
protection for the miner, other considerations shall be the
latest available scientific data in the field, the feasibility
of the standards, and experience gained under this and other
health and safety laws. Whenever practicable, the standard
promulgated shall be expressed in terms of objective criteria
and of the performance desired.
II (B) The Secretary of Health, Education, and Welfare, as
soon as possible, but no later than May 9, 1979, and on a
continuing basis, shall, for each toxic material or harmful
physical agent which is used or found in a mine, determine
whether such material or agent is potentially toxic at the
concentrations in which it is used or found in a mine. The
Secretary of Health, Education, and Welfare shall submit such
determinations to the Secretary. Thereafter, the Secretary of
Health, Education, and Welfare shall submit to the Secretary
all pertinent criteria regarding any such substances deter-
mined to be toxic or any such harmful agents as such criteria
are developed...
-------
FMSHA - 3
XV (7) Any mandatory health or safety standard promulgated under
this subsection shall prescribe the use of labels or other
appropriate forms of warning necessary to insure that miners are
apprised of all hazards to which they are exposed, relevant
symptoms and appropriate emergency treatment, and proper conditions
and precautions of safe use or exposure. Where appropriate, such
mandatory standard shall also prescribe suitable protection
equipment and control or technological procedures to be used in
V connection with such hazards and shall provide for monitoring or
measuring miner exposure at such locations and intervals, and in
such manner as to assure the maximum protection of miners. Where
I appropriate, any such mandatory standard shall prescribe the type
and frequency of medical examinations or other tests which shall be
made available to miners in order to most effectively determine
whether the health of such miners is adversely affected by
exposure. In the event such medical examinations are in the
II nature of research, such examinations may be furnished at the
expense of the Secretary of Health, Education, and Welfare. The
results of such examinations or tests made shall be furnished only
to the Secretary or the Secretary of Health, Education, and
XIV Welfare, and, at the request of the miner, to his designated
physician...
ADVISORY COMMITTEES
SEC. 102...
_.. (c) The Secretary or the Secretary of Health, Education, and
Welfare may appoint advisory committees as he deems appropriate to
advise him in carrying out the provisions of this Act...
INSPECTIONS, INVESTIGATIONS, AND RECORD-KEEPING
SEC. 103.
TTTTT (a) Authorized representatives of the Secretary or the Secretary of
Health, Education, and Welfare shall make frequent inspections and
investigations in coal or other mines each year for the purpose of (1)
obtaining, utilizing, and disseminating information relating to health
and safety conditions, the causes of accidents, and the causes of
diseases and physical impairments orginating in such mines, (2)
gathering information with respect to mandatory health or safety
standards, (3) determining whether an imminent danger exists, and (4)
determining whether there is compliance with the mandatory health or
safety standards or with any citation, order, or decision issued under
this title or other requirements of this Act. In carrying out the
requirements of this subsection, no advance notice of an inspection
-------
FMSHA - 4
shall be provided except that in carrying out the requirements of
clauses (1) and (2) above, the Secretary of Health, Education, and
Welfare may give advance notice. In carrying out the requirements of
clauses (3) and (4) of this subsection, the Secretary shall make
inspections of each underground coal or other mine in its entirety at
least four times a year, and of each surface coal or other mine in its
entirety at least two times a year.
IV (b) For any investigation of any accident [see the definition of
"accident" section 3(k)], the Secretary may hold public hearings, and
IX may sign and issue subpoenas for the attendance and testimony of
witnesses and the production of relevant papers, books, and documents,
and administer oaths.
VI (c) The Secretary, in cooperation with the Secretary of Health,
Education, and Welfare, shall issue regulations requiring operators to
maintain accurate records of employee exposures to potentially toxic
materials or harmful physical agents which are required to be monitored
or measured under any applicable mandatory health or safety standard
promulgated under this Act. Such regulations shall provide miners or
XIV their representatives with an opportunity to observe such monitoring or
measuring, and to have access to the records thereof. Such regulations
Xi shall also make appropriate provisions for each miner or former miner to
have access to records that indicate his own exposure to toxic materials.
Each operator shall promptly notify any miner who has been or is being
exposed to toxic materials in concentrations which exceed those
prescribed by an applicable mandatory health or safety standard, and
shall inform any miner who is being thus exposed of the corrective
action being taken.
(d) All accidents shall be investigated by the operator or his
agent to determine the cause and the means of preventing a recurrence.
Vi Records of such accidents and investigations shall be kept and the
information shall be made available to the Secretary or his authorized
XIV representative and the appropriate State agency. Such records shall be
open for inspection by interested persons. Such records shall include
XII man-hours worked and shall be reported at a frequency determined by the
Secretary but at least annually.
(e) Any information obtained by the Secretary or by the Secretary
XVII of Health, Education, and Welfare under this Act shall be obtained in
such a manner as not to impose an unreasonable burden upon operators,
especially those operating small businesses, consistent with the
underlying purposes of this Act. Unnecessary duplication of effort in
obtaining information shall be reduced to the maximum extent feasible...
Viii (g) (1) Whenever a miner or his representative has grounds to
believe that a violation of this Act or a mandatory health or
safety standard exists, or an imminent danger exists, such miner or
representative shall have a right to obtain an immediate inspection
by giving notice to the Secretary of such violation or danger...
-------
FMSHA - 5
(h) In addition to records specifically required by this Act,
every operator of a mine shall establish and maintain such records, make
such reports, and provide such information, as the Secretary or the
Secretary of Health, Education, and Welfare may reasonably require to
enable him to perform his functions under this Act. The Secretary or the
Secretary of Health, Education, and Welfare is authorized to compile,
analyze, and publish, either in summary or detailed form, such reports
of information. Except to the extent otherwise specifically provided by
this Act, all records, information, reports, findings, citations,
notices, orders, or decisions required to be issued under this Act may
be published, may be released to any interested person, and shall be
made available for public inspection.
Yin (i) Whenever the Secretary finds...that there exists in a mine
some especially hazardous condition he shall provide a minimum of one
spot inspection by his authorized representative of all or part of such
mine during every five working days at irregular intervals...
POSTING OF ORDERS AND DECISIONS
SEC. 109.
XV (a) At each mine there shall be maintained an office with a
conspicuous sign designating it as the office. There shall be a
bulletin board at such office or located at a conspicuous place near an
entrance of such mine, so that orders, citations, notices, and decisions
required by law or regulation to be posted, may be posted thereon, and
be easily visible to all persons desiring to read them, and be protected
against damage by weather and against unauthorized removal. A copy of
any order, citation, notice or decision required by this Act to be given
to an operator shall be delivered to the office of the affected mine,
and a copy shall be immediately posted on the bulletin board...
X (d) Each operator of a coal or other mine subject to this Act
shall file with the Secretary the name and address of the mine and the
name and address of the person who controls or operates the mine. Each
operator of a mine subject to this Act shall designate a responsible
official as the prinicipal officer in charge of health and safety at
that mine.
TITLE II — INTERIM MANDATORY HEALTH STANDARDS
COVERAGE
XVII SEC. 201.
(a) The provisions of sections 202 through 206 of this title
and the applicable provisions of section 318 of Title III shall be
-------
FMSHA - 6
interim mandatory health standards applicable to all underground coal
mines until superseded in whole or in part by improved mandatory health
standards promulgated by the Secretary under the provisions of section
101 of this Act, and shall be enforced in the same manner and to the
same extent as any mandatory health standard promulgated under the
provisions of section 101 of this Act.
(b) Among other things, it is the purpose of this title to
provide, to the greatest extent possible, that the working conditions in
each underground coal mine are sufficiently free of respirable dust
concentrations in the mine atmosphere to permit each miner the opport-
unity to work underground during the period of his entire working life
without incurring any disability of pneumoconiosis or any other
occupation-related disease during or at the end of such period.
DUST STANDARD AND RESPIRATORY EQUIPMENT
SEC. 202.
(a) Each operator of a coal mine shall take accurate samples of
the amount of respirable dust in the mine atmosphere by any device
approved by the Secretary and in accordance with such methods, at such
locations, at such intervals, and in such manner as the Secretary shall
prescribe. The samples shall be transmitted to the Secretary for
analysis and recording... The results of such samples shall also be made
available to the operator who shall also report as to the conditions in
the active workings of the mine, including, but not limited to, the
average number of working hours during each shift, and quantity and
velocity of air regularly reaching the working faces, the method of
mining, the amount and pressure of the water, if any, reaching the
working faces, and the number, location, and type of sprays, if any,
used.
(b) Except as otherwise provided in this subsection
(1) Effective November 9, 1980, or the operative date of this
title, each operator shall continuously maintain the average
concentration of respirable dust at or below 3.0 milligrams per
cubic meter of air.
(2) Effective November 9, 1983, the average concentration of
respirable dust in the mine shall be maintained at or below 2.0
milligrams per cubic meter of air.
X (3) Any operator who determines that he will be unable, using
available technology, to comply with the provisions of (b)(1) or
(b) (2) above may file an application for a permit for noncompliance.
A permit will be issued only if the application satisfies the
requirements of subsection (c) below.
(4) [An application, or permit may be renewed]...
-------
FMSHA - 7
X (c) Any application for an initial or renewal permit shall
contain —
(1) a representation by the applicant and the engineer
conducting the survey referred to in paragraph (2) below that the
applicant is unable to comply with the standard at specified
working places because technology for reducing the concentration of
respirable dust at such places is not available...
(2) an identification of the working places for which the
permit is requested; the results of an engineering survey of the
respirable dust conditions of each working place with respect to
which such application is filed and the ability to reduce such dust
to the level required to be maintained under this section; a
description of the ventilation system of the mine and its capacity;
the quantity and velocity of air regularly reaching the working
faces; the method of mining; the amount and pressures of the water,
if any, reaching the working faces; the number, location, and type
of sprays, if any; action taken to reduce such dust; and such
other information as may be required; and
(3) statements, by the applicant and the engineer conducting
such survey, of the means and methods to be employed to achieve
compliance with the applicable standard, the progress made
toward achieving compliance, and an estimate of when compliance
can be achieved...
VIII (g) The Secretary shall cause to be made such frequent spot
inspections of the active workings of coal mines as he deems appropriate
for the compliance with the provisions of this title.
MEDICAL EXAMINATIONS
SEC. 203.
(a) The operator of a coal mine shall cooperate with the
Secretary of Health, Education, and Welfare in making available to
each miner working in a coal mine the opportunity to have a chest
[x-ray] at given intervals to detect development of pneumoconiosis,
-------
FMSHA - 8
TITLE III — INTERIM MANDATORY SAFETY
STANDARDS FOR UNDERGROUND COAL MINES
VENTILATION
SEC. 303.
VI (a) All coal mines shall be ventilated by mechanical ventilation
equipment installed and operated in a manner approved by an authorized
representative of the Secretary and such equipment shall be examined
daily and a record shall be kept of such examination...
VIII (d) (1) Within three hours preceding the beginning of any
shift, and before any miner enters the active workings of a coal
mine, certified persons designated by the operator of the mine
shall examine such workings. Each examiner shall examine for
hazards and violations of the mandatory health or safety standards.
If such mine examiner finds a dangerous condition he shall post a
%y "DANGER" sign and notify the operator of the mine. Each such mine
examiner shall record the results of his examination with ink or
indelible pencil in a book approved by the Secretary kept for such
purpose...
(e) At least once during each coal-producing shift, or more often
if necessary for safety, each working section shall be examined for
hazardous conditions by certified persons designated by the operator to
do so. Any such condition shall be corrected immediately...
MAPS
SEC. 312.
(a) The operator of a coal mine shall have in a fire-proof
repository located at the surface of the mine a detailed accurate and
VI up-to-date map of such mine drawn on scale. Such map shall be revised
and supplemented at intervals prescribed by such engineer or surveyor.
XIV (b) The map shall be available for inspection by the Secretary,
coal mine examiners, miners and their representatives and persons owning
land or residing on the surface above the mines. Such map or revision
and supplement shall be kept confidential and its contents not divulged
to any other person, except to the extent necessary to carry out the
provisions of this Act and in connection with the functions and
responsibilities of the Secretary of Housing and Urban Development.
-------
FMSHA - 9
TITLE V — ADMINISTRATION
RESEARCH
II SEC. 501.
(a) The Secretary of the Interior and the Secretary of Health,
Education, and Welfare shall conduct such studies, research, experi-
ments, and demonstrations as may be appropriate — •
(1) to improve working conditions and practices in coal or
other mines, and to prevent accidents and occupational diseases
orginating in the coal or other mining industry;...
(4) to develop new or improved means and methods of reducing
concentrations of respirable dust in the mine atmosphere;
(5) to develop epidemiological information to (A) identify
and define positive factors involved in occupational diseases of
miners, (B) provide information on the incidence and prevalence of
pneumoconiosis and other respiratory ailments of miners, and (C)
improve mandatory health standards;
(6) to develop techniques for the prevention and control of
occupational diseases of miners, including tests for hypersus-
ceptibility and early detection;
(7) to evaluate the effect on bodily impairment and occu-
pational disability' of miners afflicted with an occupational
disease;
(8) to prepare and publish from time to time reports on all
significant aspects of occupational diseases of miners as well as
on the medical aspects of injuries, other than diseases, which are
revealed by the research carried on pursuant to this subsection;
(9) to study the relationship between coal or other mine
environments and occupational diseases of miners;...
(11) to determine, upon written request by any operator or
representative of miners whether any substance normally found in a
coal or other mine has potentially toxic effects in the con-
centrations normally found in the mine or whether any physical
agents or equipment found or used in a coal or other mine has
potentially hazardous effects, and shall submit such determinations
to both the operators and miners as soon as pqssible; and
-------
FMSHA - 10
(12) for such other purposes as they deem necessary to carry
out the purposes of this Act...
(d) The Secretary of Health, Education, and Welfare shall also
conduct studies and research into matters involving the protection of
life and the prevention of diseases in connection with persons, who
although not miners, work with, or around the products of coal or other
mines in areas outside of such mines and under conditions which may
adversely affect the health and well-being of such persons.
-------
PUBLIC LAW 92-573 — October 27, 1972
as amended by
PUBLIC LAW 94-284 ~ May 11, 1976
"CONSUMER PRODUCT SAFETY ACT"
DEFINITIONS
SEC. 3.
(a) For purposes of this Act:
XVI (1) "Consumer product" means any article, or component part
thereof, produced or distributed (i) for sale to a consumer for use
in or around a permanent or temporary household or residence, a
school, in recreation, or otherwise, or (ii) for the personal use,
consumption or enjoyment of a consumer in or around a permanent
or temporary household or residence, a school, in recreation, or
otherwise; but such term does not include — [tobacco, automobiles,
pesticides, aircraft, boats, food, drugs or cosmetics].
(2) "Consumer" product safety rule" means a consumer product
safety standard described in section 7(a), or a rule under this
Act declaring a consumer product a banned hazardous product.
XVI (3) "Risk of injury" means a risk of death, personal injury,
or serious or frequent illness...
(7) (A) "Private labeler" means an owner of a brand or
trademark on the label of a consumer product which bears
a private label.
(B) A consumer product bears a private label if (i)
the product is labeled with the brand or trademark of a person
other than a manufacturer of the product, (ii) -the person with
whose brand or trademark the product is labeled has authorized
or caused the product to be so labeled, and (iii) the brand or
trademark of a manufacturer of such product does not appear on
such label.
-------
CPSA - 2
PRODUCT SAFETY INFORMATION AND RESEARCH
jj SEC. 5.
(a) The Commission shall —
(1) maintain an Injury Information Clearinghouse to collect,
investigate, analyze, and disseminate injury data, and information,
relating to the causes and prevention of death, injury, and illness
associated with consumer products; and
(2) conduct such continuing studies and investigations of
deaths, injuries, diseases, other health impairments, and economic
losses resulting from accidents involving consumer products as
it deems necessary.
(b) The Commission may —
(1) conduct research, studies, and investigations on the
safety of consumer products and on improving the safety of such
products;
(2) test consumer products and develop product safety test
methods and testing devices; and
(3) ...assist public and private organizations, administratively
and technically, in the development of safety standards and test
methods...
PUBLIC DISCLOSURE OF INFORMATION
XIV SEC. 6.
(a) (1) Nothing contained in this Act shall be deemed to require
the release of any information described by subsection (b) of
section 552, title 5, United States Code, or which is otherwise
protected by law from disclosure to the public.
(2) All information reported to or obtained by the Commission
under this Act which contains or relates to a trade secret shall be
considered confidential and shall not be disclosed, except that
such information may be disclosed to other officers or employees
concerned with carrying out this Act or when relevant in any
proceeding under this Act.
-------
CPSA - 3
(b) (1) Except as provided by paragraph (2) below, not less than
30 days prior to public disclosure of any information (unless the
Commission finds that the public health and safety require a lesser
period of notice), the Commission shall, to the extent practicable,
notify, and provide a summary of the information to, each manu-
facturer or private labeler of any consumer product to which such
information pertains, if the information will permit the public to
readily ascertain the identity of such manufacturer or private
labeler, and shall provide such manufacturer or private labeler
with a reasonable opportunity to submit comments... If the Commission
finds that it has made public disclosure of inaccurate or mis-
leading information which reflects adversely upon the safety of any
consumer product or the practices of any manufacturer, private
labeler, distributor, or retailer of consumer products, it shall,
in a manner similar to that in which such disclosure was made,
publish a retraction of such inaccurate or misleading information.
(2) Paragraph (1) (except for the last sentence) shall not
apply to the public disclosure of (A) information about any
consumer product with respect to which the Commission has filed
an action under section 12 (relating to Imminently hazardous
products), or which the Commission has reasonable cause to believe
is in violation of section 19 (relating to prohibited acts), or
(B) information in the course of or concerning any administrative
or judicial proceeding under this Act.
(c) The Commission shall communicate to each manufacturer of a
consumer product, insofar as may be practicable, information as to any
significant risk of injury associated with such product.
CONSUMER PRODUCT SAFETY STANDARDS
II SEC. 7.
(a) (1) The Commission may by rule promulgate consumer product
safety standards. A consumer product safety standard shall consist
of one or more of the following of requirements:
XV
(A) Requirements as to packaging of a consumer product.
(B) Requirements that a consumer product be marked
with or accompanied by clear and adequate warnings or
instructions, or requirements respecting the form of warnings
or instructions.
-------
CPSA - 4
V (2) No consumer product safety standard shall require,
incorporate, or reference any sampling plan. (The preceding
sentence shall not apply to a fabric, related material, or product
which is subject to a flammability standard under the Flammable
Fabrics Act, or to glass containers.)
(b) A proceeding for the development of a consumer product safety
standard shall be commenced by publication in the Federal Register of a
notice which shall —
(1) identify the product and the nature of the risk of
injury associated with the product;...
(3) include information with respect to any existing standard
known to the Commission which may be relevant to the proceeding;
and
(A) include an invitation for any person to submit within 30
days (A) an existing standard as the proposed consumer product
safety standard or (B) to offer to develop a proposed consumer
product safety standard.
(c) If the Commission determines that (1) there exists
a standard which has been issued or adopted by any Federal agency or by
any other qualified agency, organization, or institution, and (2) such
standard if promulgated under this Act, would eliminate or reduce the
unreasonable risk of injury associated with the product, then it may, in
lieu of accepting an offer pursuant to subsection (d) of this section,
publish such standard as a proposed consumer product safety rule.
(d) (1) Except as provided by subsection (c) above, the Commission
shall accept one, and may accept more than one, offer to develop a
proposed consumer product safety standard if it determines that the
offerer is technically competent, is likely to develop an appropriate
standard within the period specified in the invitation and will
comply with the regulations of the Commission under paragraph (3)
below...
(3) The Commission shall prescribe regulations governing
the development of consumer product safety standards... Such
regulations shall include requirements —
1 (A) that standards recommended for promulgation be
supported by test data or such other documents or materials as
the Commission may reasonably require to be developed, and
(where appropriate) contain suitable test methods for
measurement of compliance with such standards...
-------
CPSA - 5
(C) for the maintenance of records, which shall
be available to the public, to disclose the course of the
development of standards, the comments and other information
submitted by any person in connection with such development
and such other matters as may be relevant to the evaluation of
such recommended standards; and
(D) that the Commission and the Comptroller General of
the United States, or any of their duly authorized repre-
sentatives, have access for the purpose of audit and examination
to any books, documents, papers, and records relevant to the
development of such recommended standards...
ADMINISTRATIVE PROCEDURE APPLICABLE TO PROMULGATION
OF CONSUMER PRODUCT SAFETY RULES
y•••
II (b) In promulgating a consumer product safety rule the Commission
shall consider relevant available product data including the results of
research, development, testing, and investigation activities conducted
generally and pursuant to this Act.
II (c) (1) Prior to promulgating a consumer product safety rule,
the Commission shall consider, and shall make appropriate findings
for inclusion in such rule with respect to —
(A) the degree and nature of the risk of injury the
rule is designed to eliminate or reduce;
(B) the approximate number of consumer products, or
types or classes thereof, subject to such rule;
(C) the public need for the consumer products subject
to such rule, and the probable effect of such rule upon the
utility, cost, or availability of such products; and
(D) any means of achieving the objective of the order
while minimizing adverse effects on competition or disruption
or dislocation of manufacturing and other commercial practices
consistent with the public health and safety...
-------
CPSA - 6
COMMISSION RESPONSIBILITY — PETITION FOR
CONSUMER PRODUCT SAFETY RULE
SEC. 10.
(a) Any interested person may petition the Commission to commence
a proceeding for the issuance, amendment or revocation of a consumer
product safety rule.
IV (b) Such petition shall... set forth its factual basis and briefly
describe the desired action.
(c) The Commission may hold a public hearing or conduct such
investigation or proceeding as it deems appropriate in regards to such
petition...
IMMINENT HAZARDS
SEC. 12.
XVII (a) The Commission may file in a United States district court an
action (1) against an imminently hazardous consumer product for seizure
of such product, or (2) against any person who is a manufacturer,
distributor, or retailer of such product, or (3) against both. Such an
action may be filed notwithstanding the existence of a consumer product
safety rule applicable to such product, or any pending administrative or
judicial proceedings under any other provision of this Act. As used in
XVI this section, and hereinafter in this Act, "imminently hazardous consumer
product" means a consumer product which presents imminent and unreason-
able risk of death, serious illness, or severe personal injury...
IV (d) (1) Prior to commencing an action under subsection (a)
above, the Commission may consult the Product Safety Advisory
Council (established under section 28) with respect to its
determination to commence such action, and request the Council's
recommendations as to the type of temporary or permanent relief
which may be necessary to protect the public.
(2) The Council shall submit its recommendations to the
Commission within one week of such request.
(3) Subject to paragraph (2), the Council may conduct such
IV hearing or offer such opportunity for the presentation of views
as it may consider necessary or appropriate...
-------
CPSA - 7
NEW PRODUCTS
SEC. 13.
XI (a) The Commission may, by rule, prescribe procedures for the
purpose of ensuring that the manufacturer of any new consumer product
furnish notice and a description of such product to the Commission
before its distribution in commerce.
._VT (b) For purposes of this section, the term "new consumer product"
means a consumer product which incorporates a design, material, or form
of energy exchange which (1) has not previously been used substantially
in consumer products and (2) for which there exists a lack of infor-
mation adequate to determine the safety of such product in use by
consumers.
PRODUCT CERTIFICATION AND LABELING
SEC. 14.
XI (a) (1) Every manufacturer of a product which is subject to
a consumer product safety standard and which is distributed in
commerce (and the private labeler of such product if it bears a
private label) shall issue a certificate certifying that such
product conforms to all applicable consumer product safety
standards, and specifying any applicable standard. Such certificate
shall accompany the product or shall otherwise be furnished to any
distributor or retailer to whom the product is delivered. Any
certificate under this subsection shall be based on a test of each
product or upon a reasonable testing program; shall state the name
of the manufacturer or private labeler issuing the certificate; and
shall include the date and place of manufacture...
(b) The Commission may by rule prescribe reasonable testing
programs for consumer products which are subject to consumer product
safety standards under this Act and for which a certificate is required
under subsection (a).
XV (c) The Commission may by rule require the use and prescribe the
form and content of labels which contain any or all of the following
information:
(1) The date and place of manufacture of any consumer
product.
(2) A suitable identification of the manufacturer of the
consumer product, unless the product bears a private label in
which case it shall identify the private labeler and shall also
contain a code mark which will permit the seller of such product
to identify the manufacturer to the purchaser upon request.
-------
CPSA - 8
XI (3) In the case of a consumer product subject to a consumer
product safety rule, a certification that the product meets all
applicable consumer product safety standards and a specification
of the standards which are applicable.
Such labels, where practicable, may be required by the Commission
to be permanently marked on or affixed to any such consumer product...
NOTIFICATION AND REPAIR, REPLACEMENT, OR REFUND
SEC. 15.
XVI (a) For purposes of this section: "Substantial product hazard"
means — ...
(1) a failure to comply with an applicable consumer product
safety rule which creates a substantial risk of injury to the
public.
(2) a product defect which (because of the pattern of defect,
the number of defective products distributed in commerce, the
severity of the risk, or otherwise) creates a substantial risk
of injury to the public;
Xi (b) Every manufacturer, distributor and retailer of a consumer
product who obtains information which reasonably supports the conclusion
that such product —
(1) fails to comply with an applicable consumer product
safety rule, or
(2) contains a defect which could create a substantial
product hazard,
shall immediately inform the Commission of such failure to comply or of
such defect, unless such person has actual knowlege that the Commission
has been adequately informed of such defect or failure to comply.
Xi (c) If the Commission determines (after affording an opportunity
for a hearing) that a product presents a substantial hazard and that
notification is required in order to adequately protect the public from
such substantial hazard, the Commission may order the manufacturer or
any distributor or retailer of the product to take any one or more of
the following actions:
(1) To give public notice of the defect or failure to comply.
(2) To mail notice to each person who is a manufacturer,
distributor, or retailer of such product.
-------
CPSA - 9
(3) To mail notice to every person to whom the person
required to give notice knows such product was delivered or sold.
Any such order shall specify the form and content of any notice required
to be given under such order...
INSPECTION AND RECORD-KEEPING
SEC. 16.
v_ (a) For purposes of implementing this Act, or rules or orders
prescribed under this Act, officers of the Commission, upon presenting
appropriate credentials and a written notice from the Commission to the
owner, operator, or agent in charge, are authorized —
(1) to enter, at reasonable times, (A) any factory, warehouse,
or establishment in which consumer products are manufactured or
held, in connection with distribution in commerce, or (B). any
conveyance being used to transport consumer products in connection
with distribution in commerce; and
(2) to inspect, at reasonable times and in a reasonable
manner such conveyance or those areas of such factory, warehouse,
or establishment where such products are manufactured, held,
or transported and which may relate to the safety of such products.
VII (b) Every person who is a manufacturer, private labeler, or
distributor of a consumer product shall establish and maintain such
records, make such reports, and provide such information as the
Commission may, by rule, reasonably require for the purposes of
implementing this Act, or to determine compliance with rules or orders
prescribed under this Act. Upon request of an officer of the Commission,
VIII every such manufacturer, private labeler, or distributor shall permit
the inspection of appropriate books, records, and papers relevant to
determining whether such manufacturer, private labeler, or distributor
has acted or is acting in compliance with this Act and rules under this
Act.
IMPORTED PRODUCTS
XVII SEC. 17.
(a) Any consumer product offered for importation into the customs
territory of the United States shall be refused admission if such
product —
(1) fails to comply with an applicable consumer product
safety rule;
-------
CPSA - 10
(2) is not accompanied by a certificate required by section
14, or is not labeled in accordance with regulations under
section 14(c);
(3) is or has been determined to be an imminently hazardous
consumer product in a proceeding brought under section 12;
(4) has a product defect which constitutes a substantial
product hazard (within the meaning of section 15(a)(2)); or
(5) is a product which was manufactured by a person who
the Commission has informed the Secretary of the Treasury is
in violation of subsection (g) below.
(b) The Secretary of the Treasury shall obtain without charge and
deliver to the Commission upon request, a reasonable number of samples
of consumer products being offered for import...
(g) The Commission may, by rule, condition the importation of a
consumer product on the manufacturer's compliance with the inspection
and record-keeping requirements of this Act and the Commission's rules
with respect to such requirements.
PROHIBITED ACTS
VTTTT SEC. 19.
(a) It shall be unlawful for any person to —
(1) manufacture for sale, offer for sale, distribute in
commerce, or import into the United States any consumer product
which is not in conformity with an applicable consumer product
safety standard under this Act;...
(2) manufacture for sale, offer for sale, distribute in
commerce, or import into the United States any consumer product
which has been declared a banned hazardous product by a rule under
this Act;
(3) fail or refuse to permit access to or copying of records,
or fail or refuse to establish or maintain records, or fail or
refuse to make reports or provide information, or fail or refuse
to permit entry or inspection, as required under this Act or
rule thereunder;
(4) fail to furnish information required by section 15(b)
[informing the Commission of substantial product hazards];
-------
CPSA - 11
(5) fail to comply with an order issued under section 15(c)
[informing the public of substantial product hazards];
(6) fail to furnish a certificate required by section 14
or issue a false certificate...; or to fail to comply with any
rule under section 14(c) (relating to labeling);...
(8) fail to comply with any rule under section 13 (relating
to prior notice and description of new consumer products); or
(9) fail to comply with any rule under section 27(e) (relating
to provision of performance and technical data)...
EFFECT ON PRIVATE REMEDIES
SEC. 25...
XIV (c) Subject to sections 6(a)(2) and 6(b) but notwithstanding
section 6(a)(l), any accident or investigation report made under this
Act shall be available to the public... and all reports on research
projects, demonstration projects, and other related activities shall be
public information.
ADDITIONAL FUNCTIONS OF COMMISSION
SEC. 27.
IV (a) The Commission may, conduct any hearing or other inquiry
necessary or appropriate to its functions. The Commission shall publish
notice of any proposed hearing and afford a reasonable opportunity for
interested persons to present relevant testimony and data.
(b) The Commission shall also have the power —
Xiii (1) to require, by special or general orders, any person
to submit in writing such reports and answers to questions as
the Commission may prescribe; and such submission shall be made
within such reasonable period and under oath or otherwise as
the Commission may determine;
-------
CPSA - 12
(2) to administer oaths;
Ix (3) to require by subpoena the attendance and testimony
of witnesses and the production of all documentary evidence
relating to the execution of its duties;
(4) in any proceeding or investigation to order testimony to
be taken by deposition before any person who is designated by the
Commission and has the power to administer oaths and, in such
instances, to compel testimony and the production of evidence
in the same manner as authorized under paragraph (3) above;...
(e) The Commission may by rule require any manufacturer of
consumer products to provide to the Commission such performance .and
technical data related to performance and safety as may be required to
carry out the purposes of this Act, and to give such notification of
XI such performance and technical data at the time of original purchase to
prospective purchasers and to the first purchaser of such product for
purposes other than resale.
(f) For purposes of carrying out .this Act, the Commission may
require any manufacturer, distributor, or retailer to sell a product to
the Commission at cost...
(h) The Commission may plan, construct, and operate a facility or
H facilities suitable for research, development, and testing of consumer
products in order to carry out this Act...
(j) The Commission shall prepare and submit to the President and
II the Congress at the beginning of each regular session of Congress a
comprehensive report on the administration of tb _s Act for the preceding
fiscal year. Such report shall include —
(1) a thorough appraisal, including statistical analyses,
estimates, and long-term projections of the incidence of injury
and effects to the population resulting from consumer products,
with a breakdown, insofar as practicable, among the various sources
of such injury;...
(5) an analysis and evaluation of public and private consumer
product safety research activities;...
PRODUCT SAFETY ADVISORY COUNCIL
IV SEC. 28.
(a) The Commission shall establish a Product Safety Advisory
Council which it may consult before taking any action under this Act.
The Council shall be appointed by the Commission and shall be composed
of fifteen qualified members, as follows:
-------
CPSA - 13
(1) five members shall be selected from governmental agencies
including Federal, State, and local governments;
(2) five members shall be selected from consumer product
industries including at least one representative of small business;
and
(3) five members shall be selected from among consumer
organizations, community organizations, and recognized consumer
leaders.
(b) The Council shall meet at the call of the Commission, but not
less often than four times during each calendar year.
XIV (c) The Council may propose consumer product safety rules to the
Commission for its consideration and may function through subcommittees
of its members. All proceedings of the Council shall be public, and a
record of each proceeding shall be available for public inspection...
COOPERATION WITH STATES AND WITH OTHER FEDERAL
AGENCIES
III SEC. 29...
(c) The Commission may obtain from any Federal department or
agency such statistics, data, program reports, and other materials
necessary to carry out its functions under this Act. Each such depart-
ment or agency may cooperate with the Commission and, to the extent
permitted by law, furnish such materials to it. The Commission and the
heads of other departments and agencies engaged in administering
programs related to product safety shall, to the maximum extent practicable,
cooperate and consult in order to insure fully coordinated efforts.
(d) The Commission shall, to the maximum extent practicable,
utilize the resources and facilities of the National Bureau of Standards],
on a reimbursable basis, to perform research and analyses related to
risks of injury associated with consumer products (including fire and
flammabllity risks), to develop test methods, to conduct studies and
investigations, and to provide technical advice and assistance in
connection with the functions of the Commission.
-------
[Note: The responsibilities of the Secretary of
Health, Education and Welfare under this Act
were transferred to the Consumer Product Safety
Commission by P.L. 92-573. For clarity the term
"Commission" has been substituted for "Secretary1
as appropriate.]
"FEDERAL HAZARDOUS SUBSTANCES ACT"
As amended by PUBLIC LAW 89-756; PUBLIC LAW 91-113;
PUBLIC LAW 91-452 and PUBLIC LAW 94-284]
DEFINITIONS
SEC.2.
For the purposes of this Act:...
(d) "Commission" means the Consumer Product Safety Commission...
(f) "Hazardous substance" means:
(1) (A) Any substance or mixture which (i) is toxic, (ii) is
corrosive, (iii) is an irritant, (iv) is a strong sensitizer,
(v) is flammable, or (vi) generates pressure through decom-
position, heat, or other means, if such substance or mixture
may cause substantial personal injury or substantial illness
as a result of any customary or reasonably foreseeable
handling or use, including reasonably foreseeable ingestion by
children.
(B) Any substances which the Commission (by regulation)
finds meet the requirements of subparagraph (1)(A) above.
(See subsection 3(a))
(C) Any radioactive substance, which (as used in a
particular class of article or as packaged) the Commission
determines is sufficiently hazardous to require labeling in
order to protect the public health.
(2) "Hazardous substance'1 shall not apply to pesticides,
foods, drugs, cosmetics, fuels or tobacco and tobacco products, but
such term shall apply to any article which is not itself a pesticide
but which is a hazardous substance by reason of bearing or containing
such economic poison.
-------
FHSA - 2
(3) "Hazardous substance" shall not Include any source
material, special nuclear material, or byproduct material.
XVI (g) "Toxic" shall apply to any substance (other than a radioactive
substance) which has the capacity to produce personal injury or illness
to man through ingestion, inhalation, or absorption through any body
surface.
XVI (h) (1) "Highly toxic" means any substance which falls within
any of the following categories: (a) produces death within fourteen
days in half or more than half of a group of ten or more laboratory
white rats each weighing between two hundred and three hundred
grams, at a single dose of fifty milligrams or less per kilogram of
body weight, when orally administered,... or when inhaled continuously
for a period of one hour or less at an atmospheric concentration of
two hundred parts per million by volume or less of gas or vapor or
two milligrams per liter or less of mist or dust, provided such
concentration is likely to be encountered by man when the substance
is used in any reasonably foreseeable manner;... or (c) produces
death within fourteen days in half or more than half of a group of
ten or more rabbits tested in a dosage of two hundred milligrams or
less per kilogram of body weight, when administered by continuous
contact with the bare skin for twenty-four hours or less.
(2) If the Commission finds that available data on human
experience with any substance indicates results different from
those obtained on animals in the above-named dosages or concen-
trations, the human data shall take precedence.
XVI (i) "Corrosive" means any substance which, in contact with living
tissue, will cause destruction of tissue by chemical action; but shall
not refer to action on inanimate surf aces >.
XVI (j) "Irritant" means any substance not corrosive within the above
meaning which on immediate, prolonged, or repeated contact with normal
living tissue will induce a local inflammatory reaction.
XVI (k) "Strong sensitizer" means a substance which will cause,
through an allergic or photodynamic process, a hypersensitivity of
normal living tissue which becomes evident on reapplication of the same
substance. Before designating any substance as a strong sensitizer, the
Commission, upon consideration of the frequency of occurrence and
severity of the reaction, shall find that the substance has significant
potential for causing hypersensitivity...
XVI (p) "Misbranded hazardous substance" means a hazardous substance
XV intended for use in the household or by children, if the packaging or
labeling of the substance is in violation of an applicable regulation
issued under section 3 or 4 of the Poison Prevention Packaging Act of
1970 or if the substance, unless exempted by section 3 below, fails to
bear a label—
-------
FHSA - 3
(1) which states conspicuously (A) the name and place of
business of the manufacturer, packer, distributor or seller; (B)
the common, usual or chemical name of each component which
contributes substantially to its hazard, (unless the Commission by
regulation permits or requires the use of a recognized generic
name); (C) the signal word "DANGER" on substances which are
extremely flammable, corrosive, or highly toxic; (D) the signal
word "WARNING" or "CAUTION" on all other hazardous substances; (E)
an affirmative statement of the principal hazard or hazards, such
as "Flammable", "Combustible", "Vapor Harmful", "Causes Burns",
"Absorbed Through Skin", or similar wording; (F) precautionary
measures describing the action to be followed or avoided; (G)
instruction, when appropriate, for first-aid treatment; (H) the
word "poison" for any "high toxic" substance; (I) instructions on
packages which require special care in handling or storage; and
(J) the statement (i) "Keep out of the reach of children" or its
practical equivalent, or (ii) if the article is intended for use
by children and is not a banned hazardous substance, adequate
directions for the protection of children from the hazard, and
(2) on which any required statements are located prominently
in the English language in conspicuous and legible type in contrast
by typography, layout, or color with other printed matter on the
label.
XVI (q) (1) "Banned hazardous substance" means (A) any toy, or other
article intended for use by children, which is a hazardous substance,
or which bears or contains a hazardous substance in such manner
that a child might be exposed to the substance; or (B) any
hazardous substance intended for use in the household which the
Commission by regulation classifies as a "banned hazardous sub-
stance" on finding that the degree or nature of the hazard involved
in its presence or use in households is such that protection of the
public health and safety can be adequately served only by keeping
such substance out of interstate commerce (any existing or possible
labeling requirement notwithstanding): Provided, that the Commission
by regulation (i) shall exempt articles, such as chemical sets,
which require inclusion of a hazardous substance(s),... and (ii)
shall exempt from clause (A), and provide for the labeling of,
common fireworks to the extent that it determines such articles can
be adequately labeled to protect purchasers and users...
REGULATIONS DECLARING HAZARDOUS SUBSTANCES AND
ESTABLISHING VARIATIONS AND EXEMPTIONS
SEC. 3.
XVI (a) (1) Whenever the Commission finds that the objectives of
this Act will be promoted (by avoiding or resolving uncertainty
-------
FHSA - 4
as to its application) , it may by regulation declare any substance
or mixture (which it finds meets the requirements stated above) to
be a hazardous substance for the purposes of this Act. . .
XV (b) If the Commission finds that labeling requirements under
section 2(p)(l) are not adequate for protection of the public health and
safety in view of the special hazard presented by any particular
hazardous substance, it may by regulation establish reasonable variations
or additional label requirements as necessary. . .
Xv (c) If the Commission finds that full compliance with labeling
requirements otherwise applicable under this Act are impracticable or
not necessary for adequate protection of the public health and safety,
it shall promulgate regulations exempting any such substance from these
requirements to an appropriate extent.
X (d) The Commission may exempt from requirements established by or
pursuant to this Act any hazardous substance or container if it finds
that adequate requirements satisfying the purposes of this Act have been
established by or pursuant to any other Act of Congress...
PROHIBITED ACTS
XVII SEC. 4.
The following acts and the causing thereof are hereby prohibited:
(a) Introduction or delivery for introduction into interstaLe
commerce of any misbranded hazardous substance or banned hazardous
substance.
(b) Alteration of a label or any other action which results in a
hazardous substance being a misbranded or banned hazardous substance.
(c) Receipt in interstate commerce of any misbranded hazardous
substance or banned hazardous substance or delivery or proffered
delivery thereof for pay or otherwise.
(d) Giving a false guarantee or undertaking [explained in section
5(b)(2) below] except by a person who relied upon a preceding guarantee
or undertaking to the same effect signed by, and containing the name and
address of, the person residing in the United States from whom he
received in good faith the hazardous substance.
(e) The failure to permit entry or inspection as authorized by
section 11(b) or to permit access to and copying of any record as
authorized by section 12.
-------
FHSA - 5
(f) Receipt, delivery or introduction into interstate commerce, of
a hazardous substance in a reused food, drug, or cosmetic container or
in a new container which is identifiable as a food, drug, or cosmetic
container by its labeling or by other identification. . .
(h) The use by any person to his own advantage, or revealing other
than to the Commission or its officers or employees, or to the courts of
any information acquired under authority of section 11 concerning any
method or process which, as a trade secret, is entitled to protection.
PENALTIES
(b) No person shall be subject to penalties (1) for having
violated section 4(c), if the receipt, delivery, or proffered delivery
of the hazardous substance was made in good faith, unless he refuses to
furnish the name and address of the person from whom he purchased or
received such hazardous substance, and copies of all documents pertaining
to the delivery of the hazardous substance to him; or (2) for having
violated section 4 (a), if he establishes a guarantee or undertaking
signed by, and containing the name and address of, the person residing
in the United States from whom he received in good faith the hazardous
substance, to the effect that the hazardous substance is not a mis-
branded hazardous substance or a banned hazardous substance; or (3) for
having violated subsection 4 (a) or 4(c) in respect of any hazardous
substance shipped or delivered for shipment for export to any foreign
country, in a package marked for export on the outside of the shipping
container and labeled in accordance with the specifications of the
foreign purchaser and in accordance with the laws of the foreign country
and actually exported.
REGULATIONS
SEC. 10.
Vii (a) The authority to promulgate regulations for the efficient
enforcement of this Act, except as otherwise provided in this section,
is hereby vested in the Commission.
XVII (b) The Secretary of the Treasury and the Commission shall jointly
prescribe regulations for the efficient enforcement of the provisions of
III section 14 [Imports], except as otherwise provided therein...
-------
FHSA - 6
EXAMINATIONS AND INVESTIGATIONS
VIII SEC. 11.
(a) The Commission is authorized to conduct examinations, in-
spections, and investigations for the purposes of this Act through
officers and employees of the Commission or through any health officer
or employee of any State, territory, or political subdivision thereof,
duly designated.
(b) For purposes of enforcement of this Act, officers designated
by the Commission, upon presenting appropriate credentials and a written
notice to the owner, operator, or agent in charge, are authorized (1) to
enter, at reasonable times, any factory, warehouse, or establishment in
which hazardous substances are manufactured, processed, packed, or held
for introduction into interstate commerce or are held after such
introduction, or to enter any vehicle being used to transport or hold
such hazardous substances in interstate commerce; (2) to inspect, at
reasonable times and within reasonable limits and in a reasonable
manner, such factory, warehouse, establishment, or vehicle, and all
pertinent equipment, finished and unfinished materials, and labeling
therein; and (3) to obtain samples of such materials, packages, or
labeling. A separate notice shall be given for each such inspection,
but a notice shall not be required for each entry made during the period
covered by the inspection.
(c) If the officer obtains any sample, prior to leaving the
premises he shall give to the owner, operator, or agent in charge a
receipt describing the samples obtained. If an analysis is made of such
sample, a copy of the results shall be furnished to the owner, operator,
or agent in charge.
RECORDS OF INTERSTATE SHIPMENT
VIII SEC. 12.
For the purpose of enforcing the provisions of this Act, carriers
engaged in interstate commerce, and persons receiving hazardous sub-
stances in interstate commerce or holding such hazardous substances
shall, upon the request of an officer designated by the Commission,
permit access to and copying of all records showing the movement in
interstate commerce of any such hazardous substance, or the holding
thereof during or after such movement, and the quantity, shipper, and
consignee thereof; and it shall be unlawful for any such carrier or
person to fail to permit such access to and copying of any record
requested when the request is accompanied by a statement in writing
specifying the nature or kind of hazardous substance to which the
request relates: Provided, that evidence obtained under this section, or
any evidence which is directly or indirectly derived from such evidence,
shall not be used in a criminal prosecution of the person from whom
-------
FHSA - 7
obtained: Provided further, that carriers shall not be subject to the
other provisions of this Act by reason of their receipt, carriage,
holding, or delivery of hazardous substances in the usual course of
business as carriers.
PUBLICITY
XIV SEC. 13...
II (b) The Commission may disseminate information regarding hazardous
substances in situations involving, in the opinion of the Commission,
imminent danger to health. Nothing in this section shall be construed
to prohibit the Commission from collecting, reporting, and illustrating
the results of its investigations.
IMPORTS
XVII SEC. 14.
(a) The Secretary of the Treasury shall deliver to the Commission
upon request, samples of hazardous substances which are being imported
VIII °r offered for import into the United States, giving notice to the owner
or consignee, who may appear before the Commission and have the right to
introduce testimony. If it appears that such hazardous substance is a
misbranded hazardous substance or banned hazardous substance or in
violation of section 4(f) [packaged in reused or new food, drug or
cosmetic containers], then such hazardous substance shall be refused
admission. The Secretary of the Treasury shall cause the destruction of
any such hazardous substance refused admission unless the substance is
exported within ninety days of the date of notice of such refusal or
within such additional time as may be permitted by the Secretary of the
Treasury.
EFFECT UPON FEDERAL AND STATE LAW
XVII SEC. 18...
Ill (b) (1) (A) Except as provided in paragraphs (2) and (3), if
a hazardous substance or its packaging is subject to a
cautionary labeling requirement under section 2(p) or 3(b)
designated to protect against a risk of illness or injury
associated with the substance, no State or political sub-
division of a State may establish or continue in effect a
cautionary labeling requirement applicable to such substance
or packaging and designed to protect against the same risk of
illness or injury unless such cautionary labeling requirement
is identical to the labeling requirement under section 2(p) or
3(b).
-------
FHSA - 8
(2) [The Federal Government and State Government
may agree to different standards or requirements for a
special purpose.]
(3) [The Commission may allow a requirement which
provides a significantly higher degree of protection, but
which will not unduly burden interstate commerce.]
(4) [labeling of fireworks] ...
-------
[NOTE: The authorities and responsibilities of
the Secretary of Health, Education, and Welfare, the
Secretary of Commerce and the Federal Trade Commission
under the Flammable Fabrics Act were transferred by
section 30 of the Consumer Product Safety Act (CPSA) to
the Consumer Product Safety Commission (CPSC).
"Commission" hereinafter refers to the CPSC.
The discretionary powers of the Commission under this
act to gather data which might be useful to toxic
substances regulation are minimal. However, the
general authorities of subsections 5(c) and 5(d) may
be currently used or potentially useful for gathering
data on the use of certain chemicals in the textile
industry.]
PUBLIC LAW 90-189 — December 14, 1967
as amended by
PUBLIC LAW 92-284 — May 11, 1976
"FLAMMABLE FABRICS ACT"
* * *
REGULATION OF FLAMMABLE FABRICS
SEC. 4...
XVII (b) Each [flammability] standard or regulation shall be based on
findings that such standard, regulation or amendment is needed to
protect the public against unreasonable risk of the occurrence of fire
leading to death, injury, or significant property damage; is reasonable,
technologically practicable, and appropriate; is limited to fabrics,
related materials, or products which have been determined to present
such unreasonable risks; and shall be stated in objective terms...
IX (c) The Commission may obtain from any person, by regulation or
subpoena, such information in the form of testimony, books, records, or
other writings as is pertinent to the findings or determinations which
he is required or authorized to make pursuant to this Act. All
information reported to or otherwise obtained by the Commission or its
representative pursuant to this subsection which contains or relates to
a trade secret or other matter referred to in section 1905 of Title 18,
United States Code, shall be considered confidential for the purpose
of that section, except that such information may be disclosed to other
officers or employees concerned with carrying out this Act or when
relevant in any proceeding under this Act. Nothing in this section
shall authorize withholding of information by the Commission from the
duly authorized committees of the Congress...
-------
FFA - 2
ADMINISTRATION AND ENFORCEMENT
SEC. 5...
VII (c) The Commission is directed to prescribe rules and regulations,
including provisions for maintenance of records relating to fabrics,
related materials, and products, necessary for administration and
enforcement of this Act...
I (d) The Commission is authorized to —
(1) cause inspections, analyses, tests, and examinations to
be made of any product, fabric, or related material which it has
reason to believe falls within the prohibitions of this Act; and
III (2) cooperate on matters related to the purpose of this Act
with any department or agency of the Government; with any State...
or with any person.
NATIONAL ADVISORY COMMITTEE FOR THE FLAMMABLE
FABRICS ACT
IV SEC. 17...
(a) The Secretary of Commerce shall appoint a National Advisory
Committee for the Flammable Fabrics Act, composed of not less than nine
members, fairly representative of manufacturers, distributors, and the
consuming public. The members of the Committee who are appointed to
represent manufacturers shall include representatives from (1) the
natural fiber producing industry, (2) the manmade fiber producing
industry, and (3) manufacturers of fabrics, related materials, apparel,
or interior furnishings. Each member appointed by the Secretary shall
hold office for not more than two years, except that any member may be
reappointed.
(c) The Secretary shall consult with the National Advisory
Committee before prescribing flammability standards or other regulations
established under this Act.
-------
PUBLIC LAW 91-601 — December 30, 1970
"POISON PREVENTION PACKAGING ACT"
[Note: Section 30 of the Consumer Product Safety Act transferred the
functions of the Secretary of Health, Education and Welfare under the
Poison Prevention Packaging Act to the Consumer Product Safety
Commission.}
IV SEC. 6...
(a) For the purpose of assisting in carrying out the purposes of
this Act, the Secretary shall appoint a technical advisory committee,
designating a member thereof to be chairman, composed of not more than
eighteen members who are representative of (1) the Department of Health,
Education, and Welfare, (2) the Department of Commerce, (3) manufacturers
of household substances subject to this Act, (4) scientists with
expertise related to this Act and licensed practitioners in the medical
field, (5) consumers, and (6) manufacturers of packages and closures for
household substances. The Secretary shall consult with the technical
advisory committee in making findings and in establishing standards
pursuant to this Act...
-------
PUBLIC LAW 93-633 — January 3, 1975
TITLE I — HAZARDOUS MATERIALS
SHORT TITLE
SEC. 101.
XVII This title may be cited as the "Hazardous Materials Transportation
Act".
SEC. 102.
It is declared to be the policy of Congress in this title to
improve the regulatory and enforcement authority of the Secretary of
Transportation to protect the Nation adequately against the risks to
life and property which are inherent in the transportation of hazardous
materials in commerce.
DEFINITIONS
SEC. 103.
As used in this title:...
XVI (2) "Hazardous material" means a substance or material in a
quantity and form which may pose an unreasonable risk to health and
safety or property when transported in commerce;
XVI (3) "Secretary" means the Secretary of Transportation;...
DESIGNATION OF HAZARDOUS MATERIALS
XVII SEC. 104.
Upon a finding by the Secretary, in his discretion, that the
transportation of a particular quantity and form of a material in
commerce may pose an unreasonable risk to health and safety O(r property,
he shall designate such quantity and form of material or group or class
of such materials as a hazardous material. The materials so designated
may include, but are not limited to, explosives, radioactive materials,
etiologic agents, flammable liquids or solids, combustible liquids or
solids, poisons, oxidizing or corrosive materials, and compressed gases.
-------
HMTA - 2
SEC. 105.
(a) GENERAL. — The Secretary may issue regulations for the safe
transportation in commerce of hazardous materials. Such regulations
shall be applicable to any person-who transports, or causes to be
transported or shipped, a hazardous material, or who manufactures,
fabricates, marks, maintains, reconditions, repairs, or tests a package
or container which is represented, marked, certified, or sold by such
person for use in transportation of hazardous materials. Such regul-
ations may govern any safety aspect of the transportation of hazardous
materials which the Secretary deems appropriate, including the packing,
XV repacking, handling, labeling, marking, placarding, and routing (other
than with respect to pipelines) of hazardous materials, and the manu-
facture, fabrication, marking, maintenance, reconditioning, repairing, or
testing of a package or container which is represented, marked, certified,
or sold by such person for use in the transportation of hazardous
materials.
(b) COOPERATION. — ... the Secretary shall consult and cooperate
with representatives of the Interstate Commerce Commission and shall
consider any relevant suggestions made by such Commission, before
issuing any regulation with respect to the routing of hazardous materials.
(c) REPRESENTATION. — No person shall, by marking or otherwise,
represent that a container or package for the transportation of hazardous
materials is safe, certified, or in compliance with the requirements of
this Act, unless it meets the requirements of all applicable regulations
issued under this Act.
HANDLING OF HAZARDOUS MATERIALS
SEC. 106.
(a) CRITERIA. — The Secretary is authorized to establish criteria
for handling hazardous materials. Such criteria may include, but need
not be limited to, a minimum number of personnel; a minimum level of
V training and qualification for such personnel; type and frequency of
inspection; equipment to be used for detection, warning, and control of
risks posed by such materials; specifications regarding the use of
equipment and facilities used in the handling and transportation of such
materials; and a system of monitoring safety assurance procedures for
the transportation of such materials.
X (b) REGISTRATION. — Each person who transports hazardous materials
or who manufactures, fabricates, marks, maintains, reconditions,
repairs, or tests packages or containers which are represented, marked,
certified, or sold for use in the transportation of hazardous materials
XII may be required to prepare and submit a registration statement not more
-------
HMTA - 3
often than once every two years which shall include, but need not be
limited to, such person's name; principal place of business; the
location of each activity handling such hazardous materials; a complete
list of all hazardous materials handled; and an averment that such
person is in compliance with all applicable criteria established under
subsection (a) above. The Secretary shall by regulation prescribe the
form of any such statement and the information required to be included.
The Secretary shall make any registration statement filed pursuant to
this subsection available for inspecton by any person without charge,
except that nothing in this sentence shall be deemed to require the
release of any information described by subsection (b) of section 552 of
XIV title 5, United States Code, or which is otherwise protected by law from
disclosure to the public.
X (c) REQUIREMENT. — No person required to file a registration
statement under subsection (b) above may transport or ship extremely
hazardous materials [not separately defined, ed.] or manufacture,
fabricate, mark, maintain, recondition, repair, or test packages or
containers for use in the transportation of extremely hazardous materials,
unless he has on file a registration statement.
EXEMPTIONS
X SEC. 107.
(a) GENERAL. — The Secretary is authorized to issue or renew, to
any person subject to the requirements of this title, an exemption from
such provisions, and from regulations issued under section 105 above, if
such person transports or ships hazardous materials at a level of
safety which is equal to or exceeds that level of safety which would be
required without such exemption, or which would be consistent with the
public interest and the policy of this title in the event there is no
existing level of safety established. The maximum period of an
exemption issued or renewed shall not exceed 2 years, but any such
exemptions may be renewed upon application to the Secretary. Each
person applying for an exemption or renewal shall provide a safety
analysis as prescribed by the Secretary to justify the grant of such
exemption. Notice of an application for issuance or renewal of an
exemption shall be published in the Federal Register. The Secretary
shall afford access to any such safety analysis and an opportunity for
public comment on any such application, except that nothing in this
XIV sentence shall be deemed to require the release of any information
described by subsection (b) of section 552 of title 5, United States
Code, or which is otherwise protected by law from disclosure to the
public...
(d) LIMITATION ON AUTHORITY. — Except when the Secretary deter-
mines that an emergency exists, exemptions or renewals granted pursuant
to this section shall be the only means by which a person may be
exempted from or relieved of under this title.
-------
HMTA - 4
POWERS AND DUTIES OF THE SECRETARY '
SEC. 109.
II (a) GENERAL. — The Secretary is authorized to conduct necessary
investigations, make reports, issue subpoenas, conduct hearings, require
IX tne production of relevant documents, records, and property, take
depositions, and conduct, directly or indirectly, research, development,
demonstration, and training activities. The Secretary .is further
authorized, after notice and an opportunity for a hearing, to issue
orders directing compliance with this title or regulations issued under
this title; the district courts of the United States shall have
jurisdiction, upon petition by the Attorney General, to enforce such
orders by appropriate means.
(b) RECORDS. — Each person subject to requirements under this
VII title shall establish and maintain such records, make such reports, and
XIII provide such information as the Secretary shall by order or regulation
prescribe, and shall submit such reports and shall make such records and
information available as the Secretary may request.
VI11 (c) INSPECTION. — The Secretary may authorize any officer to
enter upon, inspect, and examine, at reasonable times and in a reason-
able manner, the records and properties of persons to the extent such
records and properties relate to —
(1) the manufacture, fabrication, marking, maintenance,
reconditioning, repair, testing, or distribution of packages
or containers for use by any person in the transportation of
hazardous materials in commerce; or
(2) the transportation or shipment by any person of hazardous
materials in commerce.
II (d) FACILITIES AND DUTIES. — The Secretary shall —
(1) establish and maintain facilities and technical staff
sufficient to provide, within the Federal government, the capa-
bility of evaluating risks connected with the transportation of
hazardous materials and materials alleged to be hazardous;
(2) establish and maintain a central reporting system and
data center so as to be able to provide the law enforcement and
fire fighting personnel of communities, and other interested
persons and government officers, with technical and other infor-
mation and advice for meeting emergencies connected with the
transportation of hazardous materials; and
-------
HMTA - 5
(3) conduct a continuing review of all aspects of the
transportation of hazardous materials in order to determine and to
be able to recommend appropriate steps to assure the safe trans-
portation of hazardous materials.
II (e) ANNUAL REPORT. — The Secretary shall prepare and submit to
the President for transmittal to the Congress on or before May 1 of? each
year a comprehensive report on the transportation of hazardous materials
during the preceding calendar year. Such report shall include, but need
not be limited to —
(1) a thorough statistical compilation of any accidents
and casualties involving the transportation of hazardous
materials;...
TITLE III — INDEPENDENT SAFETY BOARD
XVII SEC. 301.
This title may be cited as the "Independent Safety Board Act of
1974".
NATIONAL TRANSPORTATION SAFETY BOARD
XVII SEC. 303.
(a) ESTABLISHMENT. — The National Transportation Safety Board,
previously established within the Department of Transportation, shall be
an independent agency of the United States, in accordance with this
section, on and after April 1, 1975.
(b) ORGANIZATION. —
(1) The Board shall consist of five members, including a
Chairman. Members of the Board shall be appointed by the President,
by and with the advice and consent of the Senate...
GENERAL PROVISIONS
SEC. 304.
(a) DUTIES OF BOARD. — The Board shall —...
-------
HMTA - 6
11 (4) initiate and conduct special studies and special
investigations on matters pertaining to safety in transportation
including human injury avoidance;...
II (8) evaluate the adequacy of safeguards and procedures
concerning the transportation of hazardous materials and the
performance of other Government agencies charged with assuring
the safe transportation of such materials;...
(b) POWERS OF BOARD. —
(1) The Board, or any designated officer of the Board, may,
for the purpose of carrying out this title, hold such hearings,
sit and act at such times and places, administer such oaths, and
require by subpoena or otherwise the attendance and testimony.
of such witnesses and the production of such evidence as the Board
IX or such officer deems advisable. Subpoenas shall be issued under
the signature of the Chairman, or his delegate...
VIII (2) Any employee of the Board, upon presenting appropriate
credentials and a written notice of inspection authority, is
authorized to enter any property where a transportation accident
has occurred or wreckage from any such accident is located and do
all things necessary for a proper investigation. The employee may
inspect, at reasonable times, records, files, papers, processes,
controls, and facilities relevant to the investigation of such
accident. Each inspection shall be commenced and completed with
reasonable promptness and the results of such inspection made
available [to whom is not specified]...
(9) The Board, or an employee designated by the Chairman,
may conduct an inquiry to secure data with respect to any matter
XIII pertinent to transportation safety, upon publication of notice of
such inquiry in the Federal Register; and by special or general
order, may require Federal, State and local government agencies and
persons engaged in the transportation of people or property in
commerce to submit written reports and answers to such requests and
questions as are propounded with respect to any matter pertinent to
any function of the Board. Such reports and answers shall be
submitted to the Board or to such employee within a reasonable
XIV period of time and in the form the Board determines. Copies shall
be made available for inspection by the public.
PUBLIC ACCESS TO INFORMATION
XIV SEC. 306.
(a) GENERAL. — Copies of any communication, document, investi-
gation, or other report, or information received or sent by the Board
-------
HMTA - 7
shall be made available to the public upon identifiable request, and at
reasonable cost, unless such information may not be publicly released
pursuant to subsection (b) below. Nothing contained in this section
shall be deemed to require the release of any information described by
subsection (b) of section 552 of title 5, United States Code, or which
is otherwise protected by law from disclosure to the public.
(b) EXCEPTION. — The Board shall not disclose information
obtained under this title which concerns a trade secret referred to in
section 1905 of title 18, United States Code, except that such infor-
mation may be disclosed in a manner designated to preserve
confidentiality —
(1) upon request, to other Federal Government departments and
agencies for official use;... and
(4) to the public in order to protect health and safety, but
only after notice to any person to whom the information pertains
and an opportunity to comment in writing, or orally in closed
session, on such proposed disclosure if the delay for comment would
not be detrimental to health and safety.
-------
PUBLIC LAW 458 ~ October 16, 1970
"AN ACT"
TITLE II — RAILROAD SAFETY
SEC. 201. SHORT TITLE.
This title may be cited as the "Federal Railroad Safety Act of
1970".
SEC. 202. RAIL SAFETY REGULATIONS.
II (a) The Secretary of Transportation shall prescribe as necessary,
appropriate rules, regulations, orders, and standards for all areas of
railroad safety supplementing provisions of law and regulations in
effect on the date of enactment of this title, and conduct, as necessary,
research, development, testing, evaluation, and training for all areas
of railraod safety...
SEC. 206. STATE PARTICIPATION.
(a) A State may participate in carrying out investigative and
surveillance activities in connection with any rule, regulation, order,
or standard prescribed by the Secretary if the appropriate State agency
submits to the Secretary an annual certification that such State agency —
(1) has regulatory jurisdiction over the safety practices
applicable to railroad facilities, equipment, rolling stock, and
operations within the State concerned;
(2) has been furnished a copy of each Federal safety rule,
regulation, order, and standard, applicable to any such railroad
facility, equipment, rolling stock, or operation, established under
this title as of the date of the certification;
(3) is conducting the investigative and surveillance activities
prescribed by the Secretary as necessary for the enforcement by him
of each rule, regulation, order, and standard referred to in
paragraph (2) above, as interpreted by the Secretary.
-------
RSA - 2
XI1 (b) Each annual certification shall include a report, in such form
as the Secretary may by regulation provide, showing — ...
(2) all accidents or incidents reported by each railroad
during the preceding twelve months involving personal injury
requiring hospitalization, fatality, or property damage exceeding
$750 or such other higher amount as the Secretary may prescribe,
together with a summary of the State agency's investigation as to
the cause and circumstances surrounding each such accident or
incident;
VI (3) the record maintenance, reporting, and inspection
practices conducted by the State agency to aid the Secretary in his
enforcement of rules, regulations, orders, and standards prescribed
by him under section 202(a) of this title, including a detail of
the number of inspections made by the State agency during the
preceding twelve months; and
VII (4) such other information as the Secretary may require...
V (e) The Secretary is authorized to conduct such monitoring of
State investigative and surveillance practices and such other inspections
VIII and investigations as may be necessary to aid in the enforcement of the
provisions of this title.
SEC. 208. GENERAL POWERS.
(a) In carrying out his functions under this title, the Secretary
is authorized to perform such acts including but not limited to,
conducting investigations, making reports, issuing subpoenas, requiring
IX production of documents, taking depositions, prescribing record-keeping
and reporting requirements, carrying out and contracting for research,
VII development, testing, evaluation, and training, and delegating to any
II public bodies or qualified persons, functions respecting examination,
inspection, and testing of railroad facilities, equipment, rolling
stock, operations, or persons, as he deems necessary to carry out the
VIII provisions of this title. The Secretary is further authorized to issue
orders directing compliance with this Act or with any railroad safety
rule, regulation, or order or standard issued under this Act; the
district courts of the United States shall have jurisdiction, upon
petition of the Attorney General, to enforce such orders by appropriate
means.
-------
XVII
RSA - 3
(c) To carry out the Secretary's responsibilities under this
title, agents of the Secretary are authorized to enter upon, inspect,
and examine rail facilities, equipment, rolling stock, operations, and
pertinent records at reasonable times and in a reasonable manner. Such
agents shall display proper credentials when requested.
TITLE III — HAZARDOUS MATERIALS CONTROL
SEC. 301. SHORT TITLE.
This title may be cited as the "Hazardous Materials Transportation
Control Act of 1970".
[Note: The "Hazardous Materials Transportation Control
Act of 1970" was repealed by PUBLIC LAW 93-633 —
January 3, 1975 included elsewhere in this compendium.]
«UA GOVERNMENT PRINTING OFFICE: 1979 620-007/3767 1-3
------- |