560TIIS82003
Chemical Substances Designation
Volume I: Overview and Analysis
ICF, Inc.
Washington, DC
Prepared for
Environmental protection Agency
Washington, DC
Dec 81
FB83--L30294
U.S. DEPARTMENT OF COMMERCE
National Technical Information Service
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PBS3- 13029U
TOXICS INTEGRATION POLICY SERIES
EPA 56 0/TI I S-3 2-OC 3
CHEMICAL SUBSTANCES DESIGNATION
- VOLUME 1:
OVERVIEW AND ANALYSIS
Project Officer:
Arnold M. Edelman
Prepared under Contract No: 68-01-6038 for the
Office of Toxics Integration
Office of Pesticides and Toxic Substances
Environmental Protection Agency
December 1981
REPRODUCED BY
NATIONAL TECHNICAL
INFORMATION SERVICE
U.S. DEPARTMENT OF COMMERCE
SPRINGFIELC VA 22161
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50277 -!C'
REPORT DOCUMENTATION l-ifS"T.'»S6o/TIT.S-82-003
3. Recipient's Accession No.
PB83 I
4. Tit»e and Sun: •>
Chemical Substances Designation
Volume I: Overview and Analysis
7. Author(s)
Bailey, et al
5. Report Date
! December 1981
B. Performing Organization Rept. No.
9. Perforn-.rng Organization Name and Address
ICF Incorporated
1850 K Street, N. W.
Washington, D. C. 20006
10. F'roiect/Task/Work Unit No.
11. Contr»c:(Q or Grant(G) No.
68-01-6038
(G)
12. Sponsoring Organization Name and Address
U.S. ENVIRONMENTAL PROTECTION AGENCY
Office of Toxics Integration
Washington, D, C. 20460
13. Type of Report & Period Covered
Informationa1
14.
15. Supplementary No'tes
16. Abstract'fLm-.it: 200 words)
This volume, part of a four'volume study, examines EPA ai
other Federal agencies statutory and regulatory criteria for the design;
tion of chemical substances. Volume I, a comparative analysis of the
statutory authorities described in Volumes II and III, focuses on
statutory purposes and goals, integration directives, the risks to be
regulated, and the factors considered for designating and regulating
chemical substances, The designation of chemical substances for regula
tion, hazard classifications and testing requirements are compared in tl
last section of Volume I, Volumes II and III review statutory provisioi
and regulations relating to the EPA and other Federal agency designatioi
c(' chemical substances. The reviews focus on the criteria used to
f'fsignate chemicals for regulation (e.g, role of economic and techno-
logical factors). The reviews specify which chemical substances are
designated for regulation and each volume describe* and analyze the
hazard classification systems established and corresponding test method
recuired by the regulations. Volume IV, the chemical designation matrl
provides a listing of the substances designated by regulation under the
statues reviewed as they appear in the Code of Federal Regulations or
the Federal Register (for proposed rules) as of January 1981.
17. Document Analysis a. Descriptors
b. id*nttfiers/Open-£nc>d Terms
c. COSATI Field/Group
IS. Availability State •nt
19. Security Class (This Report)
20. Security Class (This Page)
21. No. of Pages
22. Price
(See ANSI-Z39.18)
See Instructions on Reverse
OPTIONAL FORM 272
(Formerly NTIS-35)
Department of Commi
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NOTICE
v
,"> T-HIS DOCUMENT HAS BEEN REPRODUCED
(-,t~
fy, FROM THE BEST COPY FURNISHED US BY
X
^ THE SPONSORING AGENCY. ALTHOUGH IT
IS RECOGNIZE'.!)'THAT CERTAIN PORTIONS
^ ARE ILLEGIBLE, IT IS BEING RELEASED
.- IN THE INTEREST OF MAKING AVAILABLE
AS MUCH INFORMATION AS POSSIBLE.
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ISCLAIMER
The information included in this report include
regulations cr policies that were proposed or promulgated as of
January 1, 1981 by the U.S. Environmental Protection Agency and
other federal agencies. Because the regulations and policies
described are subject to differing interpretations and their
status may have changed since January 1, 1981, the reader is
cautioned to view the materials in this light. In addition,
this report is not intended to be a comprehensive up-to-date
listing of all regulations or policies,' but rather should be
used to retrospectively understand how agencies designate
chenical substances. The contents of this report wer° prepared
under contract to EPA and, though reviewed by EPA and other
agency staff, this review does not necessarily reflect the
views and policies of the U.S. Environmental Protection Agency
nor those of the other federal agencies whose authorities and
recuiations are reviewed.
II
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Foreword
of I?A
as well as interagency activities on chemicals is under-
standing the purposes and major objectives that must be
considered by each statute 'when designating chemicals for
regulation. Because of the numerous statutes and""regulations
with differing purposes that designate hazardous materials,
wastes or substances and toxic pollutants or substances,
confusion often results.
The purpose of this four volume study is to lay out the
key factors required by the statutes and their implementing
regulations that must be considered when designating chemicals
The document serves as a ready reference to those faced with
designing as well as complying with federal regulatory
actions regarding chemicals.
Walter V,7. Lovalick,
Director
Integration Staff
III
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Acknowledgements
The IGF Project Team owes much to the cooperation of EPA
officials and staffs throughout the agency in providing
helpful information, interpretations and comments. We
particularly appreciate the guidance and enthusiasm of the
Project Officer on this effort, Mr. Arnold M. Edelman, who
originated the concept for this study and saw it through to
completion. In addition, officials at other agencies, such
as CSHA, DOT, FDA, C?SC, USDA, and the Nuclear Regulatory
Commission also reviewed draft sections of this report, and
their comments are appreciated.
The ICF Project Manager would particularly like to thank
the Project Team members for their dedication and hard wcrk
and three individuals who managed the difficult task of
production for the volumes comprising this report:
Elizabeth Marshall, Suzanne Watkins, and Judy Lynn Lawson.
The Project Team consisted of:
Project Manager: Paul Bailey, J.D., M.P.P.
Senior Legal Associates: David Bruce, J.D., M.P.P.
Mike Goldman, J.D., M.B.A.
Associates: Lori Hashizume, M.S. (Economics)
Gilah Langner, M.P.P.
Robin Sandenburgh, M.P.P.
Ellen Taylor, M.P.P., Ph.D. (Biology)
Suzanne Watkins, M.P.?.
Research Assistants: Leslie Allen, Aaron Goldberg, Robert Irving,
Leonard Lapkin, Elizabeth Marshall
Subcontractor: Lawrence W. Bierlein, P.C.
IV
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VOLUME" 1: TA5LZ 0? CONTENTS
OVERVIEW OF THE STUDY
I . PURPOSES AND APPROACH
A . PURPOSE OF THE REPORT
B . STUDY LIMITS '
C . STUDY METHODOLOGY
BACKGROUND
PART 1: STATUTORY ANALYSIS
PART 2: REGULATORY ANALYSIS.
A. OVERVIEW ;. -. 1-
3. DESIGNATION AND STANDARD-SETTING DISTINGUISHED 1-
C. FRAMEWORK FOR ANALYSIS 18
1. INTEGRATION--STATUTORY PROVISION'S REQUIRING
CONSISTENCY WITH OTHER STATUTES 20
2. ANALYSIS OF STATUTORY PURPOSES 25
3. ANALYSIS OF STATUTORY DEFINITIONS OF HARMFUL
SUBSTANCES 3-
4. DEFINITION OF THE RISK -0
(i) TYPE OF HARM 50
(11) TYPE OF RISK 51
(ni) THE REQUIRED NEXUS OR CONNECTION: CERTAINTY,
CAUSALITY, EFFECTIVENESS 62
5. STATUTORY BASES AND FACTORS FOR LEVEL OF
PROTECTION DECISIONS 7-*
A. OVERVIEW
B. ANALYSIS OF DESIGNATED CHEMICALS
1. WHAT THE MATRIX SHOWS: AN OVERVIEW
2. NAMING CONVENTIONS AND SYNONYMS
3. DESIGNATION OF CHEMICAL GROUPS
4. DESIGNATION OF COMPOUNDS
5. DESIGNATION OF MIXTURES AND CONCENTRATIONS
C. HAZARD CLASSIFICATION AND TESTING REQUIREMENTS
1. TOXIC SUBSTANCES '
2. FIRE HAZARDS 115
3. CORROSIVE HAZARDS •.: 121
4. REACTIVE HA2ARDS .": 12^
5. RADIOACTIVE HAZARDS 130
6. OTHER HAZARD CLASSIFICATIONS 13-+
APPENDIX A: SCHEMATIC DIAGRAMS OF KEY CHEMICAL DESIGNATION LAWS .. 139
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VOLUME 1 LIST 0? 'EXHIBITS
•PAGE
1 FEDERAL LAWS CONTROLLING TOXIC SUBSTANCE EXPOSURES 10
2 USE OF DESIGNATION CRITERIA IN CHEMICAL CONTROL STATUTES... 16
3 SCHEMATIC OVERVIEW OF STATUTORY FACTORS AFFECTING
REGULATORY AUTHORITY 19
EXHIBIT 4 MAJOR STATUTORY PROVISIONS FOR INTEGRATION 21
EXHIBIT 5 STATUTORY PURPOSES 26
EXHIBIT 6 CLASSIFICATION OF STATUTORY PURPOSES 31
EXHIBIT 7 STATUTORY DEFINITION OF HARMFUL SUBSTANCES 35
EXHIBIT 8 RISK RATIONALE FOR DESIGNATION/REGULATION 41
EXHIBIT 9 STATUTORY DESCRIPTION OF THE HARM 52
EXHIBIT 10 SAMPLE RANKING OF HEALTH EFFECTS CRITERIA 55
11 RISK TERMS INCORPORATED IN STATUTORY PROVISIONS 56
12 TYPES OF CAUSAL CONNECTIONS REQUIRED BETWEEN
(1) CHEMICAL SUBSTANCES OR STANDARDS AND
(2) RISK OF HARM 65
13 REQUIRED BASES AND CONSIDERATIONS FOR
DESIGNATION/REGULATION 75
EXHIBIT 14 OVERVIEW OF STATUTORY RISK AND ECONOMIC CRITERIA 84
EXHIBIT 15 LEVEL OF PROTECTION AFFORDED BY CHEMICAL CONTROL LAWS 85
EXHIBIT 16 SOURCES OF DESIGNATED CHEMICAL SUBSTANCES 39
EXHIBIT 17 DESIGNATION OF ARSENIC COMPOUNDS IN THE REGULATIONS 96
EXHIBIT IS DESIGNATION OF ARSENIC COMPOUNDS IN THE MATRIX 98
EXHIBIT 19 DEFINITIONS OF PC3 ' s 102
EXHIBIT 20 ACUTE TOXICITY PARAMETERS 106
EXHIBIT 21 TOXICITY TESTS 108
EXHIBIT 22 FLASH POINT RANGES FOR LIQUID FIRE HAZARD CATEGORIES 116
EXHIBIT 23 DEFINITIONS OF SOLID FIRE HAZARDS ' 119
EXHIBIT 24 CORRCSIVITY TESTS 122
EXHIBIT 25 DEFINITIONS OF REACTIVE HAZARDS 126
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VOLUME 2 TABLE OF CONTENTS
?AC
TOXIC SUBSTANCES CONTROL ACT
Statutory Review
Regulatory Review. .......
CLEAN WATER ACT
Statutory Review [[[ 2-1
Regulatory Review .................................................. 2-29
SAFE DRINKING WATER ACT '
Statutory Review [[[ 2-1
Regulatory Review .................................................. 3-9
MARINE PROTECTION, RESEARCH, AND SANCTUARITES ACT
Statutory Review [[[ i-1
Regulatory Review ................................................. *-5
RESOURCE CONSERVATION AND RECOVERY ACT
Statutory Review [[[ 5-1
Regulatory Review .................................................. 5-6
FEDERAL INSECTICIDE, FUNGICIDE, AND RCDENTICIDE ACT
Statutory Review [[[ 6-1
Regulatory Review .................................................. 5-23
CLEAN AIR ACT
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T TJ""VT *"TVX"™ ••* i"- i •> T- —* rm^ « r\v " "'" ' V**T*g*
VCLJME o .Aaui -T CON.iNTS
PAG;
OCZUPAriONAl 5ATZTY AND HEALTH ADMINIS7?>ATICN
Slavatory Review , 1-2
Regulatory Review , 1-27
DEPARTMENT OF TRANSPORTATION
Statutory Review 2-2
Regulatory Review 2-9
FOOD ANTj DRUG ADMINISTRATION
Statutory Review 3-2
Regulatory Review 3-44
U.S. DEPARTMENT OF AGRICULTURE
Statutory Review 4-2
Regulatory Review 4-9
CONSUMER PRODUCT SAFETY COMMISSION
Statutory Review 3-2
Regulatory Review 5-32
NUCLEAR REGULATORY COMMISSION
Statutory Review 6-2
Regulator? Review 6-4
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VOLUME 4 TABLE OF CONTENTS
INTRODUCTION TO CHEMICAL DESIGNATION MATRIX
CHEMICAL DESIGNATION MATRIX 10
ADDENDUM 134
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£5-
THE REPORT
Tiie purpose of this four volume report is to provide information and
analysis useful in fostering intra- and interagency coordination cr. the
designation of chemicals for regulation. This study examines both the
statutory criteria for designation and classifying hazards and the
designation of chemical substances in proposed or final regulations, as of
January 1, 1961. It places a large number of statutory provisions into a
common oersoective and attempts to make them understandable.
The report serves as a baseline document for EPA' s Office of Toxics
Integration of the Office of Pesticides and Toxic Substances vhich is
designing and facilitating the development of more integrated strategies for
chemicals' across the Environmental Protection Agency (EPA). These strategies
draw on the authorities of all the appropriate statutes, including the Clean
Air Act; Clean Water Act; Resource Conservation and Recovery Act; Safe
Drinking water Act; Toxic Substances Control Act; Fedaral Insecticice,
Fungicide and Rodenticide Act; the Marine Protection Research and Sanctuaries
Act; and the Comprehensive Environmental Response, Compensation and Liabilit*.*
Act. All of these Acts, in addition to Acts administered by the Occupational
Safety and Health Administration, Consumer Product Safety Commission, Food an:
Drug Administration, Food Safety and Quality Service of the Department of
Agriculture, Department of Transportation, and Nuclear Regulatory Commission,
are included in the analyses and reviews comprising this report.
The study is organized into four volumes:
• Volume 1 -- Introduction, Background, and Comparative
Analyses
• Volume 2 -- EPA-Reiated Statutory and Regulatcry
Reviews
• Volume- 3 •- Other Agency Statutory and Regulator*'
Reviews
• Volume i — Chemical Designation Matrix
In Volume 1, the purpose and goals of the study are explained, the sco-;e
of work is specified, ana the tecnnicsi approach used to analyse the issue cf
des i-gnat ion is described. Volume 1 includes n comparative analysis of tne
statutory authorities described in Volumes II and III for the designation cf
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cnemica-s ror regulation. -t rocuses or. statutory purposes and goais,
integration directives, the risks to be regulated, and tne factors considered
for ess-gr.ari.ng and regular i.ig chacr.ic.al substances. The das igriaticr. of
cr.s.~.ical subs ranees for regulation, hazard classifications anc testing
requirements are compared in the last, section cf Volume 1 along with 3
discussion cf those chemicals designated by regulation.
Volume 2 reviews statutory provisions and regulations relating to the
EPA' s designation cf chemical suostances for regulation. Volume 3 complements
Volume 2 ay reviewing relevant non-£?A statutes and regulations. The
statutory and regulatory reviews in Volume 2 and Volume 2 focus on the
criteria used to designate chemicals for regulation. The role of economic and
technological factors in assignation and standard setting is considered as
well. The reviews specify which chemical substances are designated for
regulation under the various statutory authorities. .In addition, each volume
describes and analyzes the hazard classification systems established and
corresponding test methods required by the regulations.
vciume "• contains tne caemicai designation matrix--a listing or th-s
substances designated by regulation under the statutes reviewed here a.s they
appear in the Code of Federal Regulations or the Federal Register (for
proposed rules). The text describes how the matrix was produced, its uses,
and tne coding system -sniploved. The matrix provides a reference for those
wisr.ing tc jdou1 which chemical (s) have besn designated as hazardous under
various EPA and other Federal statutes through January 1, 1931.
,ne focus of the report is exclusively on chemical regulatory designation
issues at the Federal level, thus excluding consideration of enforcement
actions, research priorities, state plan guidance, and the issuance of
permits, variances, exemptions, exceptions, waivers, etc. In addition,
regulatory authority relating to standards of effectiveness, purity standards,
labeling (apart from cautionary labeling) stanaards, and the like which
pertain to purely economic considerations (e.g., the product must be
substantially as advertised) were not included.. Also excluded are routine
reporting retirements or other standards premised en use or production of
certain chemicals and hazardous micro-organisms or similar biological entities.
In addition, certain issues and areas have been explicitly excluded from
the scope of this study. These include:
• Agency "policies" are generally not included in the
scope of the study. Only EPA's proposed airborne
carcinogen policy and OSILA's proposed workplace
carcinogen policies were reviewed. The designation
matrix is therefore limited to formally proposed or
already promulgated regulations.
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ES-3
• Designation of toxic chemicals by nongovernmental
groups, such as the National Fire Protection
Association or the Association of American Railroads,
is not included is the scope of the study.
Finally, it was not feasible to conduct an in-depth analysis of all the
•regulations designating or naming chemical substances. Asida from the'
absolute numbers of substances involved, other complicating factors include
differences in statutory criteria for designation; variations in the level of
hazardous presented by the same substance in different environmental rr.ecia;
inconsistent use,of identifiers and naming conventions; varying priorities
among the different regulatory programs; and varying levels of scientific
uncertainty regarding risk potential of chemicals.
Therefore, the analysis of chemical substances designated by name for
regulation by January 1, 1981, takes the form of a discussion of key issues
and problems using specific examples as illustrations. The discussion is net
exhaustive. In most cases, the examples used were derived from t.ie creation
and review of a "matrix" (presented in Volume i) winch collects the various
substances designated.
In contrast, the analysis of hazard classifications and associated testing
requirements is more somprehensive. Again, only hazard classifications
proposed by January 1, 19S1 are included, with the exception of the CSKA
labelling standard waich was both proposed and withdrawn during January of
1931; it is included in the analysis for information only. Testing
requirements which are aart of hazard classifications are analysed; howavar,
many other specific testing standards exist which did not fall vithir. the
scope of this contract.
To insure- accuracy, the statutory and regulatory reviews discussed in
Volumes !, II and III were subjected to EPA and other Agency examination a::d
comment. The contractor reviews and conclusions, however, do not necessarilv
reflect the views and policies of the U.S. Environmental Protection Agency r.cr
of the other federal agencies whose authorities and regulations are reviewec.
IV. STATUTORY AND REGULATOR? ANALYSIS
Following is an overview of the cajcr findings of t.ie study which 2:2
discussed in detail in Volume I.
A. Scarutcrv Analvsis
Despite many specific variations in statutory language of over 50 distinct
provisions reviewed for the report, certain concepts reoccur: risk, benefit,
technical and economic factors ail play important roles m detar-aining
regulatory authority to designate and rsgulite chemicals. The anal'-sis covers
the key statutory provisions of the lavs included in tne study, and consicers
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1; statutory purposes, 2) def ir.it icr.s of ha~r.fi: 1 substances, 2; risk criteria,
-* required considerations, and 5) integrat ion directives.
Before discussing "he key provisions of the laws, it is important to
clarify me use of two key terms "designation" and "regulation." The former
should be thought of as "i threshold process of identifying hazards that can
be distinguished from the crafting of regulatory "star.carcs." Designation
may, be tr.su£ht cf as the identif icat ion of the problem (i.e. , identifying a
specific cr.emical as one tnat can cause adverse effects via certain
exposures). Regulation, or standard-setting, may be thought of as the
crafting cf solutions to the problem (i.e. requirements for specific action
waen exposure to the designated chemical occurs). Eoth designation and
regulation may be governed by distinct criteria and subject to different
standards of review. Typically, designation criteria are phrased in terms of
potential health effects (i.e., tcxicity) or risks presented by a substance.
Regulator? criteria are often defined by such terms'as "feasibility," "best
available technology," "margin of safety," "taking cost into account." The
main focus of this study is on the dasisnation of chemical substances as
"toxic," "hazardous," or otherwise suojecc to federal regulation. However,
because many laws do not provide distinct designation criteria, this study
also analvr.es regulatory criteria.
All regulated chesricals are designated in one way or another. However,
the definitions used in agency regulations may net be specific enough to
identify all substances subject to regulation. This is particularly a problem
when categories or generic terns are used; it is unclear whether unnamed
isomers or compounds are meant to be regulated or not. Oftentimes, a
substance (e.g., lead arsenate) may be eligible for regulation under two
different standards (e.g., the standarc. for lead compounds or the standard for
arsenic compounds), although the regulations may contain no guidance for
resolving the problem. In other cases, the chemical definition may be clear,
but other factors (e.g., size cutoffs for asbestos fibers) may cause
regulatory inconsistencies. Designation, then, is an inherent part of
standard-setting, but may also be a separate and independent administrative
action.
1. Statutory Purposes
Fundamental to an analysis of statutory authorities for designating
chemical substances is a careful assessment of the purposes for which the
statutes were developed. £ach s-t^zutory purpose directs the regulatory effort
to one or more particular concerns, and sets priorities for accomplishing the
goals outlined in the statute. Such purposes may be explicit or implied. An
ua.derstanding of the differences between statutory purposes is very useful in
attempting to understand the differences in the legal authorities fcr
designation of hazardous substances.
In particular, notable differences exist among the core purposes of the
EPA statutes. The acts' si:rr;cses range from the broad protection of health
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ES-5
and environment (HCSA, CESCLA, TSCA) to only human health (SIVA) to protection
of a specific environmental medium (CAA, CVA) . Tna terms "restore,"
"improve," and "enhance" unique to the CVA, CEKCLA, and CAA imply a more
active government role than the term "protect." On the otner hand, the
statutory purpose forms just one element in the analysis of regulitcry
authority. Volume 1 analyses each purpose relevant to health and safety
regulation as it appears in the statute. It is noteworthy that net all
statutes explicitly state their purpose.
-• Definitions af Harmful Substances
One of the key factors shaping the regulatory authority of -a statute is
the definition of these substances subject to designation and/or regulation.
Agency authority is effectively circumscribed by these definitions.
Volume 1 cocpares the definitions included in the statutes reviewed. T.ie
analysis focuses on criteria used in definitions cf harmful substances, where
this is provided (e.g., the RCRA definition of hazardous wastes). Where a
separate category is not included in the statute, the definitions of the
general category of substances subject to regulation (e.g., "materials'* 'under
M??.SA, "pesticides" under FIJRA) are identified. In the latter case, tne
statutes typically include other provisions and criteria tying designation and
regulation to seme definition of harm to be avoided.
2. Risk Criteria
After reviewing both the statutory authorities and some of the case lav
which attempt to interpret these difficult provisions, several distinct
aspects of this parameter were identified: (1) type (or magnitude) of harm
involved; (2) degree of certainty required; (3) the requ.red causal connection
between the substance, regulation, and the harm; ft) the probability of tha
harm (i.e., magnitude of the risk); and (3) tha type cf risk subject to
control (e.g.-, unreasonable risk).
7or convenience, the analysis groups these aspects of risk into three
parts:
(1) Tvae of harm involved, which is mere or less
explicitly described in the statute and/or subsumed
under risk terms;
(2) TVse of risk involved, which induces the -agr.ituce
(i e., prooability) cf the risk as well as the type of
risk subject to control (e.g., unreasonable risk,;
(3) Required nexus or connection between the substance,
regulation, ana the harm or risk involved, whicn is
described by statutory terms relating to probc'o il if.
uncertainty, and eaoisality. (e.g., raasonao./
anticipatec, cose or present}
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Net every statute incorporates all of these aspects. And the statutory
te— s used tend to overlap and be ambiguous, at times. Zistir.guish :ng these '
aspects for the purpose of comparative analysis may seem like a con:rising
exercise ir. semantics ar.d legal interpretation. However, statutorv
ic.iosyr.crac.i2S in defining risks prevent a simpler approach. - '
N,
- . Required Cons iceratior.s
.Statutory language often guides the designation and standard-setting
process by explicitly providing a specified basis for making decisions as veil
as factors to be considered. In discussing chase issues, it is essential to
cist ir.guish among:
• bases for decisions,
• factors which must be considered,
• factors which may be considered, and
• factors which mav not be considered.
addition, the statutes reviewed oft an differ as to the amount of
protection or risk reduction they authorize. Many statutes refer only to the
issuance of standards "necessary," "adequate," "desirable" or "sufficient" to
protect the public health. Sorae give more detailed guidance (e.g., ample
margin of safety, no material impairment of health). Others address this
issue by prescribing particular factors as the basis for standard-setting (or
as natters for consideration). These laws allow for the balancing of risk and
cost considerations, as another way of establishing a level of protection.
Volume 1 identifies those provisions and distinguishes among risk, economic
and technical bases for regulatory actions.
5. Integration Directives
The report identifies legal provisions concerning interagency and
intra-agancy integration (e.g. , coordination, cooperation, csr.su]cation) in
the designation of hazardous chemicals. Experience with these provisions and
with regulatory integration is limited. However, there is anecdotal evidence
which indicates that specific Congressional directives can facilitate the
promulgation of integrated regulations.
B. Regulator--- Analysis
There are two different ways that chemical substances can be designated
and regulatsa. One approach is to identify and list specific chemical
substances in the applicable regulations. The other approach is to identify
the harmful characteristics or effects (hazard classification) which would
qualify a chemical for regulation, leaving it,up to private industry to
aetcrmine (test) which substances have such .characteristics or effects. While
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each approach "hes particular" problems, regulatory programs frequently us a bcth
approaches («.g., RCRA, DOT, FtFHA).
1. Identification and Listing
In order to compile ail various chemicals designated, a cnemicai
'designation matrix listing those substances designated by name in all the
agancy reguations which were reviewed was devised. In addition, to listing all
chemicals, the matrix also highlights designation problems. Siffarent naming
conventions, incomplete and cveriappir.g cnemicai groups, lack of syr.cr.yr;s , ar.c:
different treatment of compounds and mixtures all make it vary difficult to
follow one substance through several regulations. The matrix lists hundreds
of chemicals designated by Federal agencies.
The primary factors that determine which substances are designated are the
regulatory authority embodied in statutory risk criteria and trie availaaie
scientific evidence. Thus, it is difficult to make analytical ir.ferar.cas from
the matrix. Just because a substance is listed does r.o~ mean it is ur.sa.fa in
all uses or exposures. Conversely, iust because a sucstar.ces .-.as not beer.
designated does not -jean that it is safe in all uses or exoesuras. The use
of or tne environment affected by a particular substance may cstar-ir.e its
classification. For example, a chemical in food eyes may be classified as
toxic, whereas the sane chemical used in pesticides may not be. Also, the
assumptions that agencies make concerning risk assessment are likely to vary.
These assumptions concern such issues as dose relationships, margins of
safety, and models of data extrapolation, and may affect which chemicals are
designated as hazardous. Finally, the manner in which agencies view exposure
levels to substances may vary. Some agencies may consider the effects of
chemicals as additive; other agencies consider the effects of chemicals
individually, as if humans were exposed to chemicals in the absance of ether
exposure routes.
Despite the difficulties in comparing the designation of hazardous
substances, the form of the matrix emphasizes several importent aspects of the
way agencies designate chemicals.
• use of differing naming conventions arid definitions,
and limited use of synonyms for listed substances
The variety of naming conventions would not necessarily
be a significant problem if the regulations themselves
provided suitable cross-refersnces to synonyms. Thay do
not. In fact, tracing the regularory status of a
particular chemical is often quite difficult. FV?C.» §307
regulations do not <;e^e"ally identify synonyms, while FVPC.A
§311 regulations do list all synonyms of each substance,
whether taere are two names or five for one chemical
substance. HMTA regulations usually list only one r.ame,
excest in a few ir-stances vnere- two names are listac. RJTIA
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regulations *ist some synonyms, nut nor ail of the time.
FIFRA regulations often do net adeauately crosr -reference
brand r.anes to chemical names. This problem is corn-sounded
by the alternative ways that chemicals, are designated in
use of generic tarms designating groups of substances
The use of generic categories further complicates the
analysis of assignation. Designation cf a class of
chemicals (e.g., chlorinated benzenes) can subsume many
individual substancss. The prcolem arises when agencies
define or interpret designated chemical groups in different
ways.
• Differing approaches to the designation' or inclusion
of compounds, isomers, etc. and the treatment of
mixtures.
A basic uncertainty is the definition (or lack of a
definition) of the word "compound." An agency designates a.
chemical, such as arsenic, as hazardous, and then nay or
may not list -sr otherwise include its compounds, isomers,
hydrates, or mixtures. Cn the ether hand, the regulations
may specify that the element or compound specifically
listed includes other forms.
Agencies also give categories special definitions that do not clearly
follow the category name. For example, under OSHA §6b, "inorganic arsanic''
includes "copper aceto-arsenate, and all inorganic compounds containing
arsenic except arsine, measured as arsenic" (29 CFR 191C.101S(b)). Copper
acoto-arsenate, in a strict sense, is net an inorganic chemical, because it
contains organic carbon. Arsine, on the other hand, would normally be
considered an inorganic arsenic compound, 'when comparing the OSHA dcsignatior
with FVPCA §211, wnich also covers inorganic arsenic compounds, it is clear
the latter does not utilize the same definition"as CSHA.
2. Hazard Classification and Testing Requirements
Many regulations designate not only specific chemicals, but also
characteristics of chemicals, as hazardous. The use cf characteristics or
classifications has several advantages. First of all, under these rules, it
is usually the responsibility of industry to tf.st specific chemicals and
mixtures of chemicals for dangerous properties. Secondly, this "generic
approach" results in far more cocprehensive coverage than listing individual
substances, since ail matarials--nct just those materials-that the agencies
are aware of and have the resources to anaiyze--srust be evaluated against tne
harara criteria. Finally, specifying general 'types of dangers also provides
structure to the regulations. Labeling and handling requirements are
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ES-9
frequently organized according to hazard so that substances that pose similar
risks are treated in similar fashion. In this way, hazard classes may
determine how-, as well as which chemicals ara regulated.
Is establishing generic hazard classifications agencies have sat up (1)
exact, testable categories, (2) more general descriptive isfir.itions and, (3)
'in some instances, no definitions at all. precise categories that ara-
delineated by standard physical, chemical or biological tests, such as
flash-point ranges, appear to be the most useful. In many cases, hovever,
there are no reliable or comprehensive tests that cover all of t.-.a substances,
that, for proper handling, should be grouped ir. one category.
The different agencies, mandates, and methods have resulted in differing
classifications, testing requirements, and test levels that regulated industry
must satisfy. Soma attempts have been made to coordinate regulations; for
instance between EPA under RCRA and ~GT under HMTA. ' How-aver, differences
exist both among and within different agencies' programs. Cne important
reason for this is the fact that each regulation controls a different type of
exposure--a characteristic which is hazardous in one medium (e.g., consumer
products) may not be deemed hazardous in another for which public exposure is
smaller (e.g., solid waste)..
The analysis in Volume I shows the kinds of classification used and what
tests must be satisfied. Hazard categories (and associated testing
requirements), that have been established by seven different agancies under
nineteen separata statutes are reviewed. The analysis covers the following
generic hazardous classifications:
• Toxic Substances
Fire Hazards
• Corrosive Hazards •
• Reactive Hazards
• Radioactive Hazards
• Other Hazard Classifications
Volume I reviews each of these classifications, discusses the crizaria arid
tasting required, and identifies similarities and differences. For e.xamp 1=;,
• the same tests for metal corrosion are used by Z?A
and DOT
The two regulations which cover metal corrosion reo.uira identical steel
corrosion tests. The RCRA test was taken directly from DOT Hazardous
Materials rules aftar EPA determined that the Agency's "concern accut
container damage is identical to that of DOT's."
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use of differing ranges, characteristics and testing
",o ce-ermine fira hazards.
~'r,der ~".C~A, F.'IFRA, KMT-, Coasi C-uari and OSiiA, various flammability
a.ef;."_^ior.;5 and testing aethods have been established. The flash :cint ranges
vhicu define the classes under the various programs differ according to the
tsrrpararurss normally incident to handling the respective materials. For
r.xamrla. :'-.£ i^C'F "ig:.iti.biiity" criterion estabished unde: RCRA vas chosen
spec if ic.il ly to relate to "the potential sources of ignition existing at a
lancfill site, such as not truck exhaust pipes and heat from neutralization
The regulations differ net only in the flash point ranges used to define
the hazard categories, but also in the test methods authorized for determining
the ignition temperatures. Most of the classifications require th«i use of
"closed-cup" tests (Pensky-Martens, Setaflash, or Tagliabue), vhil=. FHSA and
USCG raandase use of t-r,. ooen c-jp test, which typically gives higner flash
oc mt results
v • CONCLUSIONS
The 3any laws authorizing regulation of hazardous chemicals contain
numerous differences ',3. statutory language and criteria. Although seme of
tnese differences may be insignificant, other differences are substantive.
These requirements may be found in previsions defining ths substances to be
regul-iteo,, the purposes of the legislation, the risk criteria, factors or
bases for decisions, and directives for integrating regulations with other
programs. Risk, technical, and economic considerations'-- and relationships
betvaen and among these ;"?ctors -- appear in various combinations and guises.
'The analysis of statutory language in Volume 1 and the reviews contained in
Vcluces 2 and .3 can bi u?ed to identify key language as well as judicial
int'jry^'-ite.*: :cns , if ar.y , i'-r.d agency i;.iplemsntation.
Regulations desigr.atuag hazardous chemicals use both hazard
classifications (e.g., flamraables) and lists of covered chemicals and synonyms
to identify substances meant tc be included. In the case of hazard
classifications, a number of technical and terminological inconsistencies
exist; similar problems occur with the use of lists -- different naming
conventions, incomplete synonyms, overlapping generic designations, and
ambiguity over the designation of compounds are not uncommon. The regulatory
analyses in Volume 1, the reviews in ^'olumes 2 and 3, and the chemical
ces;,,™:aticTi matrix in Volume <* can be us<>d to identify what chemicals have
Dee;1., cesignateii and hew, -in addition to the hazard classifications and testing
:s proposed or affective as of January 1, 1981.
""•;•„" T»rert does not focus on nor emphasize the overall consistency of
c'?r,il regulations dealing with designation of hazardous chemicals. In
n'=ra^, Federal regulations GO not conflict. However, complicating factors
'.c, ' fs fiffe"an~ statute-—? r.jncates and.'or differences in the regulator-.-
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£3-11
environaent (e.g., transportation conditions, disposal concerns, or var
chemical properties) often prevent identical chemical lists, performance
standards, etc. These differences can be appropriate. Or. tha otr.er ha
this report attempts to identify potential inconsistencies for further
consideration as opportunities for better integration. . -
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' "OVERVIEW ' OF THE -S~"JDY
Statutory authorities for designating chemical substances for government
regulation are scattered among many federal laws and regulatory agencies. The
purpose of this report is to review and analyze all these laws, focusing on
the specific statutory criteria and regulatory requirements for designating
chemical substances.
The report is organized into four volumes:
• Volume 1 -• Executive Summary, Background' and
Comparative Analyses
• Volume 2 -- E?A-Related Statutory and Regulatory
Reviews
• Volume 3 -- Other Agency Statutory and Regulatory
.Reviews
• Volume <* -- Chemical Designation Matrix
In addition to an executive summary, Volume 1 contains an overview of the
study, a discussion of its purpose and,the approach used, background
information, the statutory analysis, the regulatory analysis, and an appendix
containing schematic diagrams of key laws. The statutory and regulatory
analyses compare and contrast material compiled in the statutory and
regulatory reviews comprising Volumes 2 and 3.
Volume 2 reviews statutory provisions and regulatory requirements
relating to the Environmental Protection Agency's designation of chemical
substances for regulation. The following EPA authorities are reviewed:
• Toxic Substances"Control Act
• Federal Water Pollution Control Act
• Safe Drinking Water Act
• Marine Protection, Research and Sanctuaries Act
• Resource Conservation and Recovery Act
• Federal Insecticide, Fungicide, and Rodenticide Act
• Clean Air Act
• Comprehensive Environmental Response, Compensation and Liability
4-- '
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Volume 2 complements Volume 2's coverage of Z?A authorities by reviewing
relevant ncn-E?A statutes and regulations. The following agencies' statutory
authority to designate as.c regelate chamical substances are reviewed:
• Occupational Safety 33d Health Administration
• Department of Transportation/United States Coast Guard
• Focsd and Drug Administration
• United States Department cf Agriculture
• Consumer Product Safety Commission
• Nuclear Regulatory Commission
The statutory and regulatory reviews in Volume 2 and Volume 3 focus on
the criteria used to designate chemicals for regulation. For example, the
designation of some chemicals may be based on human toxicity, whereas other
chemicals may be designated because of their toxicological effects on aquatic
organisms. The role of economic and technological factors in designation and
standard setting is consider ad as well. The reviews also specify which
chemical substances are designated for rsgulation under the various statutory
authorities.
•
Volume i contains the chemical designation matrix--a listing of the
substances designated under :h9 statutes reviewed here as they appear in the
Code of Federal Regulations or th* Federal Register (for proposed rules). The
text describes how the matrix was produced, its uses, and the coding system
en-olcved.
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-3-
I. PURPOSE AND APPROACH
PURPOSE OF THE REPORT
The purpose of this report is to provide information and analysis useful
in fostering intra- and intsragency coordination concerning the designation of
chemicals for regulation. This study examines statutory bases for
designation, classification of hazards, tasting requirements, and the
designation of chemical substances in proposed or final regulations, as of
January 1, 1981. The report places a large number of statutory provisions
into perspective and attempts to maXe them understandable.
The goal of fostering intra-agency coordination concerning the
designation of chemicals for regulation is an agency priority which is being
implemented by the Office of Toxics Integration of the Office of Pesticides
and Toxic Substances. The agency's goal is to develop integrated strategies,
drawing on authorities of one or more appropriate EPA statutes, including the
Clean Air Act; Clean Water Act; Resource Conservation and Recovery Act; Sara
Drinking Water Act; Toxic Substances Control Act; Federal Insecticide,
Fungicide and Rodenticide Act; the Marine Sanctuaries and Protection Act; and
the Comprehensive Environmental Response, Compensation and Liability Act. ill
of these Acts are included in the analyses and reviews comprising this report.
The scope of this study also includes the examination of other laws
governing toxic substance hazards used by the EPA and the Occupational Safety
and Health Administration (OSKA), Food and Drug Administration ("A),
Department of Transportation (COT'), Nuclear Regulatory Commission (N~RC),
Department of Agriculture (USDA), and the Consumer Product Safaty Commission
(CPSC). The focal point of the study remains the EPA. Trie study dees not
extensively -consider issues of interest only to the other agencies (e.g.,
DGT-KRC coordination in designating radioactive substances).
STUDY LIMITS
Certain issues and areas have been explicitly excluded from the scope of
this study. These include:
• Agency "policies" are generally not included in the
scope of the study. Only EPA's proposed airborne
carcinogen policy and CSKA's proposed workplace carcinogen
policies have been reviewed. The designation matrix is
limited-to formally proposed or already promulgated
regulations.
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• International (e.g., IMC3, OE3D) rules and cor.venia.ons
are not included in the scope of the study.
Inconsistencies and conflicts between federal rules and
international requirements have not been .systematically
investigated.
• State actions relating to designation have not been
included. Only federal statutes and regulations have been •
analyzed.
* Designation of toxic chemicals by nongovernmental
groups, such as the National Fire Protection Association
or the Association of American Railroads, is not included
in the scope of the study.
Moreover, the focus is exclusively on regulatory designation issues, thus
excluding consideration of enforcement actions, research priorities, si tare
plan guidance, and the issuance of variances, exemptions, exceptions, waivers,
perairs, etc.,
In addition, the focus is exclusively on the regulation of substances
with respect to their potential adverse effects on health, the environment, or
property; we have not considered or reviewed regulatory authority relating to
standards of effectiveness, purity standards, labeling (apart from cautionary
labeling) standards, and the like which pertain to purely economic considera-
tions (e.g., the product must be substantially as advertised). Nor have
routine reporting requirements or other standards premised on use or produc-
tion cf certain chemicals been systematically included. Also, hazardous
micro-organisms or similar biological entities are not included in th« review;
only non-living chemical substances are considered.
STUDY .METHODOLOGY
The approach used to prepare this study can be described quite simply as
consisting of three parts:
(1) Statutory Reviews
(2) Regulatory Reviews
(3) Statutory and Regulatory Analyses
The statutory reviews formed the input to the analysis of statutory
authorities. The regulatory reviews formed the basis for the comparative
analysis of hazard classification and testing requirements as well as the
analysis cf chemicals designated. The interrelations among these tasks can be
shown graphically:
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-5-
Starutory' Reviews
(Volumes 2 & 3)
Regulatory Reviews
(Volumes 2 i 2)
Designation \
i
i
Volume 4 I
Analysis of
Statutory
Authorities
(Volume 1)
Analysis of
Chemicals
Designated
(Volume 1)
Analysis of
Hazard Classes
and Tasting
(Volume 1)
To insure accuracy, the statutory and regulatory reviews were subjected
to agency examination and comment. The reviews can be found in Volumes 2 and
3 of this report. The designation matrix is included in Volume <+. The
analyses are presented in Volume 1. ICF's approach to each of the major tasks
is summarized below.
Statutory Reviews
As noted earlier, this study analyzes the statutory provisions for
designating chemical substances enacted by January 1, 1981. The legal
analysis of statutes required the review of:
• the statute itself
• its legislative history
• Congressional committee reports
• court cases (and settlements) construing the statute
• administrative interpretations
• • law review articles
• treatises and other commentary
The statutory authorities listed in Exhibit 1 (above) were reviewed.
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Trie szazui.es were reviewed zo determine general and/or specific mandazas
arid authorities zo identify and regulate chemicals as hazardous zo human
health anc/CT the environment. In addizion, 1C? examined zhe following
aspeczs of Che statutes:
• statutory purpose;
• integration manaazes;
• definitions of "hazardous" and "zoxic" substances;
• kind of harm sought zo be avoided;
• level of causalizy and certainty required;
• criteria for designation and szandards, (e.g., zoxicizy,
benefit/cost considerazions, margin of safety).
Reported legal cases interpreting relevanz szazuzory language were
analyzed, emphasizing administrative and policy implicazions of decisions.
1C? described the Legal basis and razionale for each imporzanz judicial
decision, izs precise holding(s), findings, and implications. "Dicta" were
carefully distinguished from language having precedential value. Historical
material was included only as necessary.
Furthermore, 1C? determined whezher szazuzory provisions wers judicially
tested or otherwise affirmed. For example, zhe scope of DOT authority in
designating materials as hazardous has not been judicially reviewed.
Regulatory Reviews
Virtually all regulations zhaz relate zo the designation of chemical
substances promulgated or proposed by January 1, 1S81 were reviewed for this
stucy. 1C? examined and summarized all notices of proposed and final
ruiemakiags, including agency preambles. Relevant crizeria documents (e.g.,
air Quality and Water Quality Criteria Documents) were reviewed, particularly
for information about specific factors used to designate and regulate
substances. Reported legal cases reviewing the regulations were analyzed ::or
their substantive implications regarding agency discretion to designate
chemicals for regulation. Finally, discussions with agency staff and thei::
cstameats an the draft contributed to the research base.
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-7-
The regulatory review required the examination of:
• the chemicals designated or listed;
• criteria for selection (e.g., health effects);
• " definitions;
« naming conventions;
• quantity limits and concentrations;
• basis for standards (e.g., technology, toxicity^
J •
Analysis of Statutory Authorities
The aethodology followed in perforating this analysis is relatively
straightforward.
First, IC7 identified the key issues to be included in the analysis. The
following issues were selected.
• statutory oursose—this was selected because courts
typically refer to a statute's goals when interpreting
agency regulatory authority
• integration directions, guidance, or constraints--this
was selected because several statutes make some type of
provision for integration, coordination, or consultation
• risk to be avoided--this issue is crucial in
determining the scope of statutory authority and has
several components: the severity, probability, type, and
certainty (i.e. causality) of harm
• factors for designating and regulating substances--
this issue likewise is crucial for analyzing che roia of
economic and technical factors
An in-house "questionnaire" was then used ta organise the aaterial
reviewed by the project tnflrn for the analysis of these issues. Both zhe
statutory and regulatory reviaws served as sources for rue inforaarion neecad.
Chemical Designation Matrix Analysis
The study team reviewed the chemical substances designated for regulation
by constructing a "matrix" showing which ch.eau.cal substances have beer.
designated under which statutory authorities. The aatris provides an overview
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-s-
of the scope sf government regulation of'toxic chemicals. Use of :.he matrix
can facilitate identification of nomenclature problems in toxic chemical
regulations. These and related issues are discussed in acre detail later in
Vc lume '. •
Analysis cf Hazard Classifications and Testing Requirements
The ICF st'j.dy team cotapared and reviewed the various hazard classifica-
tions and tests that are required under different agencies and EPA programs.
Regulations under each act often include different classifications, leading to
conflict aaong various categories. Test requirements, in the form of such
things as the number of animals used, how the results should be measured, and
the type of test method employed, are often a critical part of the definition
of each category'. In this analysis ICF reviewed each classification with its
associated tests and discussed how the regulations under each statute dealt
with various classifications, if at all. Exhibits comparing the different
classifications are orovided.
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-9-
II. BACKGROUND OF THE STUDY
Chemical substances are properly designated "hazardous" and subject to
government regulation as a result of the risks they pose to human health ar.d
safety and to the environment. These risks result from manufacture or
processing (worker exposure, environmental release, disposal, spills, fugitive
emissions), transport (spills, fugitive release, worker exposure during
loading and unloading), and consumer use. Exposure may be to hazardous
consumer products, chemicals, feedstocks, intermediates, by-products, and
wastes. Risks from multiple exposures and unpredictable synergistic effacts
complicate designation decisions.
In most instances, risks are probabilistic; that is to say, not eve—rone
will be exposed nor will everyone exposed suffer adverse consequences.
Moreover, in all instances, there remains much scientific uncertainty
concerning such important issues as:
• exposed population at risk
• dose-response relationships
• threshold levels
• magnitude, scope, and certainty of health effects
Not only is the available scientific data often inadequate, but even
methodologies for risk-assessment may not be well-suited to analyzing risks
imposed by chronic low-level exposures having latent effects under conditions
of considerable uncertainty.
Understandably, the regulation of hazardous chemicals has tended to
emphasize acute effects. The risks posed by explosives, poisons and
corrosives_are easier to understand; control measures are easier to evaluate;
and health and safety effects are easier to test and monitor. However, the
past ten years have witnessed a profound change. There is an increasing
awareness and concern about carcinogenic and reproductive hazards, the chronic
risks they pose, the cost of controls. The result has been a flurry of
legislative activity oriented around the protection of human health and safaty
and the environment. Exhibit 1 presents an overview of federal statutes
concerned with toxic substance control.
The laws listed in Exhibit 1 recognize that hazardous chemicals may be
encountered on the job, in the environment, in household and consumer
products, in food, drugs, and cosmetics, and in drinking water. Exposures aay
be direct or mediated. Toxic substances may move through the food chain; they
can migrate from storage lagoons and dumps into wells and streams; they can
penetrate packaging; they can be inhaled, ingested, or absorbed throughout the
product cycle from synthesis to preparation, through processing, distribution,
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FEDERAL LAWS CONTROLLING TOXIC SUBSTANCE EXPOSURES
Statute Agenc
Clear, air Act EPA
(197C, amended IS77)
Federal Water Pollution EPA
Control Act
(1972, amended 1977, 1978)
Safe Drinking Water Act EPA
(197i, amended 1977)
Federal Insecticide, EPA
Fungicide and Rodenticide
Act (19<-3, amended 1972)
Pesticide Residues Amendment1- EPA
(195-, amended 1972)
Marine Protection, Research EPA
and Sanctuaries Act (1972)
Resource Conservation and EPA
Recovery Act (1976)
Toxic Substances Control Act EPA
(1576)
Comprehensive Environmental EPA
Response, Compensation, and
Liability Act" (1981)
Occupational Safety and OSKA
Health Act (1970)
Food, Drug and Cosmetic Act FDA
(1932)
Coveraee
Air pollutants
Water oollutants
Drinking water contaminants
Pesticides
Pesticide residues in food
Ocean dumping
Hazardous wastes
All chemical hazards no:
covered by other lawsij
Hazardous substances,
pollutants and
contaminants
Workplace exposures
Food, drags, cosmetics
ljCodified as Section 3^6(a) of the Food, Drug and Cosmetic Act.
ijAlso requires pre-market evaluation of all new chemical substances except
fooc additives, drugs, pesticides, alcohol, and tobacco.
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•LI
Statute
EXHIBIT 1 (continued)
FEDERAL LAVS CONTROLLING TOXIC SUBSTANCE EXPOSURES
Agency Coverage
FDA
Food Additives Amendment
(1953)
Color Additive Amendments FDA
(1960)
Mew Drug Amendments (1962) FDA
New Animal Drag Amendments FDA
(1968)
Medical Device Amendments FDA
(1976)
Wholesome Meat Act (1967) USDA
Wholesome Poultry Produces
Act (1963)
Egg Products Inspection Act
(1970)
Federal Hazardous Substances CPSC
Act (1966)
Consumer Product Safety Act CPSC
(1972)
Poison Prevention Packaging CPSC
Act (1970)
Lead-Based Paint Poison CPSC
Prevention Act (1973,
amended 1976)
Hazardous Materials DOT
Transportation Act (1970)
Ports and Waterways Safety DOT-USCG
Act (1972)
Dangerous Cargo Act (1952) DOT-USCG
Atomic Energy Act (1954) NSC
Food additives
Color additives
New drugs
Animal drugs and faed
additives
Medical devices
Food, faed, color additives,
and pesticide residues
Toxic household srcducts
Dangerous consumer products
Packaging of dangerous
products
Lead paint in federally-
assisted housing
Transportation of hazardous
materials
Water shipment of zoxic
materials
Water shipment of toxic
materials
Radioactive sucstances
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anc transportation, to incorporation into products and final disposal.
Fugitive emissions, emergency releases and unintentional spills all contribute
to possible exposures.
Legislation enacted episodically by Congress as it perceived specific
needs for additional controls has resulted in the complex of hazardous
caemicais statutes; listed in Exhibit 1. As a result, many widely used
substances fall under the jurisdiction of more than one law within ar agency
and aicra than one federal agency:
* Tor example, a dozen substances have each been designated
for regulation under seven or more separate authorities as
of January 1, 1981, (acryloiiitrile, aidrin, asbestos,
benzene, cadmium, chlordane, DDT, endrin, heptachlor, lead,
mercury, vinyl chloride).1-1
• The full regulation of all sources of exposure to vinyl
chloride would involve action by five different agencies
operating under 15 statutes.2J
• Tvo or ;aore meaner agencies of the Interagency Regulatory
Liaison Group (IRLG) were involved in the regulation of 21
different hazardous materials.3-1
• Several agencies administer more than one toxic substance
control program.
Conpliance on the part cf the regulated community may be rendered more
difficult and costly because of jurisdictions! fragmentation. Businesses may
find themselves the object of multiple requirements of several different
federal laws and agencies. Oftentimes, control measures designed to reduce
one type cf exposure (e.g., workplace standards) may result in increases of
ether types of exposures (e.g., air emissions or solid waste),
The fragmentation of agency jurisdiction also he.,~ been credited with
encouraging protracted litigation both by industries desiring to be regulated
under a less stringent authority and also by public interest groups desiring
:j Chemical Substances Designation, Volume 4 (1981).
2J Dcniger, "Federal Regulation of Vinyl Chloride: A Short Course on
Toxic Substances Control Law and Policy," 7 Ecology Law Quarterly 498-658
(1S78).
3* Regulatory Reporter, Interagency Regulatory Liaison Group, December
1SSC.
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-13-
regulations under a more stringent standard."J This sort of litigation
results when the relevant agency statutes differ on issues such as the burden
of proof and the consideration of economic factors.
In addition co inter-agency jurisdicticnal problems, there are also
important coordination problems within agencies. The EPA adminis-ers a
number of extensive regulatory programs under eight separate statuses, net
including the recently enacted Comprehensive Environmental Response,
Compensation, and Liability Act. Within a single act such as the Clean Air
Act, separata criteria are listed for new sources, existing sources, mobile
sources, hazardous pollutants, etc. Chemicals may constitute differsnt
priorities in different media control strategies for purely technical
reasons. Thus, the problems of jurisdictional conflicts and duplica-
tive/inconsistent actions can be as serious within an agency as they are
between agencies.
*JDcniger, Liroff and Dean, "An Analysis of Past Federal Efforts zo
Control Toxic Substances" (Environmental Law Institute, Final Report, July 20
1978), p. i,3.
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The comparative analysis of statutory authorities is a major par" of this
four-voiuae study. Despite the many specific variations in the statutory
language, certain themes reoccur: risk, benefit, technical, and economic
assessments all play important rolas in determining regulatory authority to
designate and regulars chemicals. Drawing upon the statutory and caselaw
reviews, a unique framework for analyzing statutory authority and its
components was developed. The analysis covers the key statutory provisions of
the laws included in the study. The analysis considers statutory purposes,
definitions of hazardous substances, risk definitions, required
considerations, and integration directives. Prior to the analysis, it is
necessary to first clarify some basic terminology used in this report: the
distinction between designation and regulation.
Included Appendix A is a series of "schematic diagrams" of the key
statutory provisions analyzed. Symbols in the diagrams represent mandates o:r
authorities,, key definitions, and required considerations; the diagrams show
the interrelations among the statutory provisions of the different regulatory
programs as well as the distinction between designation and regulation.
Because we distinguish designation from regulation, the number of
statutory provisions analyzed is quite large. We also analyze a substantial
number of topics. This analysis is complicated by the fact that ail the
statutory provisions of a given law interact to define the bounds of
regulatory authority. It is very difficult to say meaningful things about
si -=»cific aspects of regulatory authority in isolation. Nevertheless, this
art-roach al _cws for a systematic consideration of the key aspects of
regulatory authority when developing integration strategies.
DESIGNATION AND STANTiAIO-SETTING DISTINGUISHED
At the start, it is important to clarify the use of two key terms
"designation" and "regulation." The former should be thought of as a
threshold rrocess of identifying hazards that can be distinguished from the
crafting cf regulatory "standards." Both designation and regulation may be
governed by distinct criteria and subject to distinct standards of
review.5- Typically, designation criteria are phrased in terms of risks or
potential health effects (i.e., toxicity) presented by a substance.
Regulatory criteria are often defined by such terms as "feasibility", "best
available technology", "margin of safety", "taking cost into account". In
certain instances, different regulatory criteria are established for differing
agency actions. ror example, the criteria for requiring labeling may be less
stringent than the criteria authorizing the ban of a dangerous chemical. The
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main focus of this study is on the designation of chemical substances as
"toxic", "hazardous", or otherwise subject to federal regulation. See Exhibit
2. However, because many laws do not provide distinct designation criteria,
this study also analyzes regulatory criteria.
A useful way of understanding the role of designation versus regulation
is as follows. Designation nay be thought of as the identification of the
prob1em. A chemical exposure may be considered a public health problem if
the probability and severity of harm along with the extent of the affected
population meet certain criteria. Also, of course, a causal connection
between the chemical substance and the harm mist be established. Regulation,
or standard-setting, nay be thought of as the crafting of solutions to tne
problem. At a minimum, the standard mist be effective and aay also be subject
•;o cost considerations.
Designation, then, is an essential threshold decision which determines
whether a chemical substance (in particular concentrations and amounts) say
be subject to further regulatory standards and how the chemical is defined.
For example, certain hazardous compounds or isomers may be designated for
regulation using any one or more of several different naming conventions.
Alternatively, a chemical substance may be designated by being a recognized
part of a designated group of chemicals or by meeting the tastmg criteria of
a designated hazard classification (i.e., "flammables'1, "corrosives"}.
Finally, only certain concentrations of a substance may be designated or even
particle size (e.g., size specifications for asbestos fibres) nay se—/e as a
designation parameter.
Either as a separate administrative action or as part of the designation
decision, the formulation of standards for designated substances activates
control, labelling, or penalty regulations, among others. For example,
designated chemicals may be subject to the following kinds of regulatory
standards:
• testing requirements
• reporting requirements
• recordkeeping requirements
• liability for clean-up of spills
*JFor example, the listing of toxic pollutants under Clean Water Act,
Section 307(a)(1), is subject to the "arbitrary and capricious" standard of
review but the development of effluent standards for toxic pollutants under
Section 307(a)(2) must meet the "substantial evidence" test.
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-v "Trrv-"'- '""•^W'
_.> **..«..,,. WA.J w ^11 fc
Clean Air Act - generally used, Sections 108, 111, 112-
Clsai: Warer Acr - used, bozh Section 307 and Section 311
TSCA - sot used-
HCPvA - used, Section 3001
SDWA - used in Section 1412, but permit progran used in
Section 1421 instead
MPSSA - pernit progran used instead
"FRA - perait and classification program used in geneiral
CZRCLA - used, Section 102
OSHA - not used
c/
FDA - permit progran generally used instead-'
3CT - classification system used
CPSA - not used
FHSA - mixed case
M'RC - permit program used instead
a/Not -used irL Sections 151, 202, 211, or 231 which authorize or mandate
direct regulation without prior designation.
b/Except fsr authority to list certain substances, Section 5(b)(4)(A),
which has not bees exercised, and Section 4(a).
c/Ixcept for cosmetics, for which preaarket approval is not required.
Also FDA :.s recuired to "list" approved color additives.
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-17-
• labeling and placarding rules
• use res-crier ions
* exposure controls in manufacturing
• disposal requirements
• packaging and transportation specifications
• bans
• medical surveillance
• fines and penalties
• emission limits and prohibitions
• ambient concentration standards
Similar requirements may also be imposed under statutes which designate
whole classes of substances (e.g., pesticides, drugs, food additives) for
regulation, such as FIFRA, MPRSA, and 7DCA. These laws require pre-market or
pre-disposal approval.
Designation, then, is an inherent part of standard-setting but may also
be a separata and independent administrative action. Although the distinction
between designation and standard-setting is conceptually straightforward, in
practice the distinction is often blurred for a variety of reasons:
(1) Statutes do not consistently separate designation from
regulation nor prescribe distinct criteria for each.
(2) Standard-setting criteria (e.g., technological feasibility)
may render moot the designation of substances whose control
options do not satisfy the criteria.
(3) Judicial review of the authority to designate will generally
take into account the regulatory purpose of the designation
authority in order to assess the designation decision.
As Exhibit 2 shows, many statutes do NOT contain separate designation
criteria. These laws fall into two groups:
(1) Blanket-coverage laws, such as FTFRA, MPRSA (Ocean Dumping
Act), and the Food, Drug, and Cosmetic Acts. These laws regulate
all substances qualifying as pesticides, materials, and fooc
additives, respectively, and only apply special requirements to a
-------
-13-
subset of these substances . !J These laws treat all covered
substances as potentially unsafe until a regulation, permit, cr
tolerance authorizing use or disposal is promulgated.
(2) Another group of laws uses the "unreasonable risk" concept as
a basis for regulation. Here, too, there is no distinct
designation phase, but regulation is the axce-otior., not the rule.
Later in this part of the report we discuss the required bases and
considerations for making both designation and regulation determinations . Our
goal here is to clarify the distinction between these two concepts as a basis
for the analytical comparisons which follow. None of the literature reviewed
identifies this important distinction or takes it into account when analyzing,
for example the role of economic factors in exercising agency authority.
VORX FOR ANALYSIS
To provide structure for this analysis, a framework was developed to
include the key statutory provisions which together define regulatory
authority-- for both designation and standard-setting. These include the
following:
(1) statutory guidance concerning integration cr
coordination procedures;
( 2 ) statutory purposes or goals ;
(3) definitions cf hazardous chemicals included within
the jurisdiction of a statute;
(«) distinctive definitions of the risks which are
properly addressed by- agency regulations; and
(5) recuired considerations and bases 'for designation
and/ or regulation decisions.
Each of these issues will be analyzed in detail in the following sec-
tions. Their relationship to the concept of regulatory authority is shown by
Exhibit 2. A court, in reviewing challenged agency actions is likely to
ej?or this reason, the chemical designation matrix in Volume 4 includes
cc.ly substances banned by the FDA, not the thousands that have been approved
for use under normal conditions. Likewise, only pesticides or pesticide
ingredients subject to special requirements or restrictions are included in
the matrix.
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-19-
EXKI3IT 3
SCHEMATIC OVERVIEW OF STATUTORY FACTORS AFTICTING REGULATORY AUTHIRITY
Integration
Requirement
REGULATORY
AUTHORITY
and Recuirad
onsiderations
Definition of
The Sabsrancas
4B
Tjpe and
Severity
of Kara
Resolution
of
Uncertainty
Causality
Probability
of
Haras
E^ENTS COMPRISING STATUTORY RISK CRITERIA
-------
consider a.-- c: tnese factors, depending on tae sunstantive., nature or tne case
or controversy involved. The numbers in Exhibit 3 indicate the order in which
the factors ara discussed in the analysis.
:NTZGRAT:ON--;TAT'JT:RY PROVISIONS REQUIRING CONSISTENCY WITH OTHER STATUTES
This secr-ion deals with the major pro-visions (or lack thereof) in aach of
the statutes administered by EPA that require consistency and coordination
with other statutes. Exhibit 4 summarizes these provisions. The text which
follows describes ia greater detail how some of these provisions work or were
designed to work (or fail to work) in three of these statutes: (1) The Clean
Water Act, (2) The Toxic Substances Control Act, and (3) the Resource Conser-
vation and Recovery Act. The regulations reviewed suggest that statutory
provisions requiring consistency may play a significant role in regulatory
outcomes.
The Clean Water Act TSection 311)
The Clean Water Act (also called the Federal Water Pollution Control Act)
requires that regulations issued under Section 211(b) (dealing with discharges
of oil or hazardous substances) "be consistent with maritime safety and with
marine and navigation laws and regulations and applicable water quality stan-
dards." Section 311(b)(3). However, the Act does not address consistency
with safety regulations used by DOT for other modes of transport. Although
EPA reporting and penalty regulations under this section are triggered only
when there actually is a spill during transport, the Department of Transporta-
tion (DCT) has continuous jurisdiction over the transportation of hazardous
substances. This means that when a spill occurs, both agencies have jurisdic-
tion. Despite this potential for jurisdictional overlap between EPA and DOT
in xhe area of transportation and discharge of hazardous substances, there is
nc specific mandate in Section 311 that these two agencies work together or
issue consistent rules.
In fact, a nunber of regulatory inconsistencies between EPA and DOT rules
in this area have arisen. First, DCT regulations require reporting of
discharges only when navigable waters or adjacent shorelines are involved,
while EPA requires all spills to be reported, regardless of location. In
addition, DCT defines a reportable quantity in terms of the contents of one
package or one vehicle; EPA has no such requirements (if several "packages"
are discharged, none of which alone is a reportable quantity, but the sum of
which is repcrtafale, then reporting is required by ZPA but not by DCT).
Finally, DCT rules specify that only discharges of substances in certain
minimum concentrations of a hazardous chemical are reportable. EPA has no
minimum concentration reauirements.
-------
-21-
EXHI3IT 4
MAJOR STATUTORY PROVISIONS FOR INTEGRATION
FEDERAL WATER POLLUTION CONTROL ACT (FWPCA)--Regulations issued under
Section 311 (discharge standards) must "be consistent with maritime safety and
with marine and navigation laws and regulations and applicable watar quality
standards." Section 31100(3).
Section 307(k)(l) provides that "[t]he Administrator shall antar into
agreements with" the Secretaries of Agriculture, the Araiy, and the Interior
and with other agency heads "to provide for the maximum utilization cf ocner
federal laws and programs" to achieve and maintain water quality.
TOXIC SUBSTANCES CONTROL ACT (TSCA)--If both TSCA and other federal laws
administered by EPA could be utilised to protect against a particular risk,
the Administrator shall act under TSCA only when he determines that it is in
the public interest to do so. Sections 6(c)(l), 9(b).
If both TSCA and other federal laws not administered by EPA could be
utilized to protect against a particular risk, the Administrator must submit a
report about the risk to the agency that administers such other law. If that
agency responds by issuing an order stating that the risk described in the
report is not actually presented or by initiating, within 90 days, action
against such risk, then the Administrator may not take action under Sections 5
or 7 with respect to that risk. Section 9(a).
RESOURCE CONSERVATION AND RECOVERY ACT (RCRA)--RCRA shall not apply to
activities or substances subject to the FWFCA, SDWA, MPRSA or Atomic Energy
Act except when such application is "not inconsistent with" those Acts.
Section 1006(a).
RCRA administration and enforcement shall be integrated with and avoid
duplication of the CAA, FrfPCA, FIJRA, SBWA, MPRSA, and other Acts administered
by EPA. Section 1006(b).
RCRA standards relating to transporters of hazardous waste shall be
"consistent" with the Hazardous Materials Transportation Act and shall be
promulgated after consultation with the Secretary of Transportation. The
Administrator may make recommendations to the Secretary of Transportation
concerning regulations under and materials to be covered by that Act. Section
2003.
COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION AND LIABILITY ACT--I:
there is a conflict between CZRCLA and Section 311 of the FWPCA, CZRCLA
applies. Section 304(c).
Section 103 is generally not applicable to pesticides registered oncer
FT7RA. Section 103(e). Similarly, Section 103 notification of releases which
"must be .reported and have been resorted under RCRA is not recuired. Section
103(f).
-------
EXHIBIT i (continued)
MAJOR STATUTORY PROVISIONS "OR INTEGRATION
The guidelines published pursuant to Section 106 shall be. consistent with
the national hazardous substance response plan and shall include the
assignment of responsibilities and powers authorized by parrs cf the FVPCA,
RCRA, SUVA, OAA, and TSCA. Section'106(c).
SAFE DRINKING VATZR ACT (SUVA)--When EPA prescribes interim or revised
national primary drinking water regulations, the ?cod and Drug Administration
shall consult with the Administrator and within ISO days, either amend bottled
drinking water regulations or publish reasons for not so doing. Section 410,
Federal Food, Drug, and Cosmetic Act.
MARINE PROTECTION. RESEARCH. AND SANCTUARIES ACT (MPRSA)--"Dumping" does
not induce (1) certain effluent cispositions regulated under the FVPCA or the
Atonic Energy Act; (2) construction or placement on or in water, for a purpose
other than disposal, regulated by or pursuant to federal or state laws or
programs; and (3) deposits "made for the purpose of developing, maintaining,
or harvesting fisheries resources" regulated by cr pursuant to federal or
state laws or programs. Section 2(f).
CLEAN AIR ACT (CAA)--No najor statutory provisions for integration.
FEDERAL INSECTICIDE, FUNGICIDE. AND RODENTICI3E ACT (FI7RA)--The
Administrator shall consult with "otner interested Federal agencies" before
e-taolishing procedures and regulations for disposal or storage of
-..: sticides . Section 19(a).
The Administrator shall "provide advice and assistance to the Secretary
cf Transportation" concerning the transportation of hazardous materials.
Section 15(b).
The Administrator shall cooperate with the Department of Agriculture and
other agencies in carrying out FIFRA and "securing uniformity of
regulations." Section 22(b).
Packaging, container, and wrapping standards "shall be consistent with
those established under the authority of the Poison Prevention Packaging
Act." Section 25(c).
In Organized Migrants in Community Action vs. Brennan, 520 F.2d 1161
(D.C. Cii. 1S75), the court held that, pursuant to FIFRA, EPA, not the
Secretary of Labor under the Occupational Safety and Health Act, has authority
to provide protection for fans workers from hazards arising from pesticide
exposure.
-------
-23-
As a result of this, industry remains subject to two sets of conflisting
regulations, although EPA has advised DOT that it will not bring actions for
failure to report under EPA regulations when such reporting is not required by
DOT regulations. As will be seen in the discussion of RCRA below, however,
EPA and DOT have been able to work together under that statute; cne potential
explanation for the problem here is simply that the statuta does not require
close coordination.
The Toxic Substancas Control Act
The Toxic Substancss Control Act (TSCA) specifies quits clearly new
situations should be handled in which both TSCA and other statutes could be
applied to prevent or reduce a particular risk. If the other statutes are
administered by EPA, TSCA is to be used only if the Administrator finds that
it is "in the public interest" to act under TSCA. Sections 6(c)(l), 3(b). If
the other statutes are administered by other agencies, EPA must submit a
report to that agency about the risk it perceives. Only if the other agency
neither (1) issues an order declaring chat the risk is not presented as
described in the report, nor (2) initiates action against the risk within 30
days, may the Administrator take action under Sections 6 or 7. Section 9.
This same section also claarly sets out that EPA is to consult and coordinate
with other federal agencies "for the purpose of achieving the aaximum
enforcement of [TSCA] while imposing the least burdens of auplicative
requirements" on industry.
Several points concerning these provisions are made ia the legislative
history of TSCA. First, the Administrator's determinations are "discretionary"
in both (1) Section 9(a) that a law administered by another agency may prevent
or reduce a particular risk and (2) Section 9(b) that the use of TSCA instead
of another law administered by EPA is in the public interest. This aeans that
these determinations are not subject to judicial review.7J Second, in
Section 9(a), the other agency need not initiate formal regulatory action
within the 90-day period in order to foreclose EPA action, it must only
officially initiate action-which will "culminate as soon as possible1' in-
regulatory action.IJ
The question which must still be addressed hare is how well has this
section worked. A single answer can not be given; an answer will be attsapted
based on a review of chlorofluorocarbons (CFCs) regulations.
7J E.R. Report No. 94-1679, 94th Cong., 2d Sess., 84, S3 (1975). In
the second case, this report indicates that even though the Administrator's
decision is unreviewable, a reviewing court is expected to require that he
examined the other authorities and presented the results of that axaminatior
when making his findings. H.R. Report No. 94-1679 at 25.
-------
With respect to C~Cs, the initial federal response to the "problem, -he
result of a joint effort of EPA, the Food and Drug Administration, the
Consumer Procuct Safety Commission, and the Department of Commerce, is
regarded as a triumph of interagency cooperation. These agencies worked
together as the lr,teragency Work Group on Chlorofluorocarbons in promulgating
final riles tnat eliminated both costly duplication (which could result from
having to prepare separate regulations and impact statements) and industry
confusion (that nay result from different definitions, effective dates, and
warning labels). The credit for successful interagency action may, however,
not have been due so much tc the requirements of the statute as the publicity
the issue received., the early contact the agencies made with each other, and
their general agreement on a course of action.
The Resource Conservation and Recovery Act
The Resource Conservation and Recovery Act (RCRA) explicitly provides in
Section 1006(b) that its administration shall be integrated with and avoid
duplication of the CAA, FWPCA, "I7RA, SDWA, MPRSA, and other acts administered
by EPA. In Section 1006(a), RCRA also states that it shall not apply to
activities or substances subject to the FWPCA, SDWA, MPRSA, or Atomic Energy
Act-except when such application is "not inconsistent with" those Acts. But
the provisions of RCRA that are of greatest interest here are those contained
in Section 20C3. That section requires that the standards under RCRA relating
to transporters of hazardous waste shall be consistent with the Hazardous
Materials Transportation Act ana shall be promulgated after consultation wit.n
the Secretary of Transportation. The Administrator is also authorised to aa.
-------
-25-
ANALYS.S OF STATUTORY PURPOSES
An analysis of statutory authorities for designating chemical substances
for government ragulation requires a caraful assessment of the purposes for
which the statutes were developed. The statutory purpose directs the regula-
tory effort to one or more particular concerns, and sets priorities for the
accomplishment of the goals outlined in "he statute. Whether the purpose is
explicit or implied, it will direct the way in which the statutory aandate is
carried out by different agencies. In fact, the differences in statutory
purposes are very useful in attempting to understand tae differences in the
designation of hazardous substances.
Statutory purposes explain dissimilar designations of chemical substances.
For example, chemical hazards are addressed differently by the Federal water
Pollution Control Act and the Safe Drinking Water Act. The purpose of the
latter is to protect drinking water; one would expect stricter regulations
than those for water not directly ingested. Statutory purposes nay also be
important factors in a court's evaluation of hazardous chemical designations.
"or example, courts are likely to distinguish between designating chemical
substances for the purpose of triggering testing requirements and designating
for the purpose of establishing consumer product health standards.
Exhibit 3 presents each purpose relevant to health and safety regulation
as it appears in the statute. Not all statutes explicitly state their purpose.
In cases when no formal statement of purpose was included in the statute, leg-
islative history and legal decisions were reviewed for statements of congres-
sional intent, purpose, and policy. These statements, as collected in Exhibit
5, easily illustrate the variety of fora and content among statutory purposes.
The specificity of statutory purposes varies. Some statutes list the
specific methods to be used to achieve their statutory goals. RCRA, for
example, specifies how its objectives are to be set as does the GSH Act.
Other statutes, such as the KMTA, simply declare a general purpose and do not
detail the methods to be used to fulfill it.
Another difference arises in the basic purpose of each act. Of rha sta-
tutes reviewed, the most salient purpose is to protect human health; protection
of the environment also is a prominent purpose. Exhibit 6 illustrates the
differences in focus by arranging the statutes into two groups: Those sta-
tutes that are intended to protect (1) human health and, the environment, and
(2) human health only. As would be expected, most of the SPA-relatad statutes
have the dual purpose of protecting human health and the environment.
-------
-26-
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EXHIBIT 6
CLASSIFICATION QF STATUTORY PURPOSES
Human Health and the Environment
Human Health Cnlv
RC5A
a/
SDVA
CESCLA
b/
HMTA
TSCA
a/
•I7RA
CSHA
§/
FT3A
CVA
b/
AZA
MPRSA
USDA Laws
CAA
3?SC Laws
USCG Laws
a/ The purpose is not explicitly stated in ;he sratuia.
is found in the legislative history.
b/ Tnese statutes are also intended to protect agamst
risks to trocertv. Regulations issued under HifTA cc
address environmental as well as health and property
-------
Ir. particular, note the differences among -he core purposes of -he EPA
s-a.rut.es.
CVA Restore and Maintain Integrity of the Nation's Waters
SDWA Protect Public Health ^
RCRA Protect Health and the Environment
CZ71CLA Protect Hunan Health and Improve the Environment
TSCA Protect Hunan Health and the Environment
riFRA Protect Public Health and the Environment
MPRSA [Protect] Human Health, welfare, or the Marine Environment
CAA Protect and Enhance the Quality of the Nation's Air
The terns "restore", "improve", and "enhance" used in the CVA, CEiRCLA,
and CAA imply a mere active government role than tne term "protect". However,
the other laws often have extensive control powers—such as the permit system
required -under the J1PRSA. In addition, the Clean Air Act concern-with air
quality is conditioned by the goal of promoting the public health and
welfare. Of course, the statutory purpose forms just one element in the
analysis of regulatory authority--other statutory provisions will be involved.
In a landmark Clean Air Act case, concerning the legality of regulations
allowing .companies to "bubble" out of new source performance standards, the
D.C. Circuit Court of Appeals rested its holding, in part, on the fact that
"bubbles" do nothing to improve air quality (but do cut costs) and cited the
goal of the Clean Air Act to "enhance" air quality, not merely to "maintain"
The ncn-EPA statutes primarily address the protection of public health
(TDA, CSDA, and C?SC laws). The OSHA Act's purpose as to "assure" "safe and
healthful working conditions" "so far as possible". The Atomic Energy Act
seeks to "maximize" the contribution of atomic energy to the general welfare
consistent with the health and safety of the public. The DOT laws, finally,
give auch attention to the protection of property, some of the Coast Guard's
laws also address the protection of the environment.
ASASCS. Inc. v. EPA, 11 ESC 1129, 1125; 578 F.2d 319 (D.C. Cir.
-------
-33-
Note that the HMTA does not explicitly men-ion any concern, with the
environment, per se. Only hazards to life and property are referenced. This
is also the case with the AEA, which nowhere mentions the environment.
• It has been argued, for example, that DOT has no authority
under the HMTA to regulate hazardous materials that pose
only environmental risles. DOT took the opposite position in
its rulemakings adopting hazardous substances and wastes
designated by the EPA pursuant to CVA and RC3A. Because the
environment mediates many toxic exposures, an agency cannot
protect human health without controlling the presence of
toxics in the environment. But materials toxic only to fish
or wildlife and not humans, on the other hand, would not
seem to fall under the ambit of the HJfTA unless they also
constituted someone's property (e.g., privately owned oystar
beds). There has been no judicial test of DCT's authority
to resolve this issue.
Some provisions are more specific than others in their descriptions of
health related purposes. TSCA, RCRA, and MPRSA, for example, define the types
of health effects to be prevented, i.e., "unreasonable risk of injury",
"adverse effects". At the other extreme is the Glean Air Act which severally
states as its goal "to protect the public health ..." Likewise, the Clean
Water Act merely implies that one of its purposes is to protect human health
by stating: "It is the national policy that the discharge of toxic pollutants
in toxic amounts be prohibited." Prohibiting the discharge of toxic
pollutants will reduce human exposure to toxics in the water, and presumably,
protect human health. These issues are discussed in more detail in later
sections of the analysis dealing with statutory risk criteria.
Besides public health, economic issues are often addressed in the
statutory purpose. Some of the statutes aim to favorably affect the
economy. An example is the Atomic Energy Act which, (among other things),
purports "to strengthen free competition in private enterprise" (emphasis
added). Other statutes are designed so that actions under the statute will
avoid aggravating or damaging the economy, including adverse effects on
economic potentialities (MPRSA), human resources (CSHA), or the econoaic
benefits of the use of a pesticide (FIFRA). Economic considerations
invariably are part of the regulatory process to one degree or another,
whether they are mentioned as a statutory purpose or not. Usually, economic
factors enter either as part of the definition of the risk (e.g., unreasonable
risk) or as a required consideration in promulgating a standard. These issues
will be addressed.later.lij
llJWe do not discuss the status and requirements of Executive Order
12291 which requires certain economic analyses.
-------
-34-
=. statutory factor closely related to the "purpose-" is the definition' of
-hose substances subject to regulation. This is reviewed next.
ANALYSIS CF STATUTORY DEFINITIONS OF HARMFUL SUBSTANCES
Cue of the key factors shaping the regulatory authority cf a statute is
the definition cf these substances subject to designation and/or regulation.
Agency authority is effectively circumscribed by these definitions.
Exhibit 7 lists the definitions included in the statutes reviewed. The
Exhibit focuses on definitions of harmful substances, where this is provided
(e.g., the RCRA definition of hazardous wastes). Where a separate category is
not included in the statute, the Exhibit shows the definitions of the general
category of substances subject to regulation (e.g., "materials" under MPRSA,
"pesticides" under FIFRA). In the latter case, the statutes typically include
other provisions ""ing designation and regulation to some definition of harm
to be avoided.
The statutes containing definitions of "harmful" substances use a variety
of descriptive terms such as:
• "pollutants" FWPCA §502(5)
"toxic pollutant" FWPCA §502(12)
"hazardous substance" FWPCA §3 11 (b) (2) (A)
"contaminant" SDWA §1401(6)
"hazardous waste" RCRA §3001
"hazardous air pollutant"...CAA §112(a)(l)
"air pel lutant" CAA §302 (g)
• "hazardous substance" CERCLA §101(14)
• "pollutant or contaminant"..CERCLA §104(a)(2)
"hazardous materials" HMTA §103(2)
"hazardous material" 3FCLA"J 49 USC §4417 (a) (2) (C)
• "hazardous substance" FHSA §2(f)(1)
The most popular terms are "hazardous substance" (defined differently in
CWA §311, CERCLA" §101(14), and FHSA §2(f)(l), "hazardous material," and
"contaminants." The use of the term "hazardous substance" by CERCLA is most
unfortunate since it includes CWA §311 "hazardous substances" as well as
other substances. Rules adopted by DOT to incorporate §311 "hazardous
substances" as DCT "hazardous materials" further complicate the lexicon.
It should be noted that the Toxic Substance Control Act does not define
or otherwise use the tern "toxic substances". Rather, TSCA defines "chemical
substances" and "mixtures" which are subject to regulation if certain harm
criteria are met. Likewise, neither FIFRA nor the MPRSA specify a category of
harmful substances; FTFRA defines "pesticides" which are all subject to
regulation as does MPRSA with "materials".
ijj3ulk Flammable and Combustible Liquids Act (U.S. Coast Guard).
-------
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Th e Occupational Safety and Health. Act uses the term ''toxic materials" _r.
§6(b)(5) but does not define that term. The "JSDA and FDA statutes provide
definitions of "adulterated" or "unsafe" products but do not define such kef
terms as "poisonous or deleterious substances". Finally, the Consumer Product
Safety Act only defines consumer products.
DEFINITION GF THE RISK
After reviewing both the statutory authorities and the case law which
attempt to interpret these difficult provisions, there are five potential,
distinct aspects to a statutory definition of risk:
(1) :ype (or magnitude) of harm involved;
(2) degree of certainty required;
(3) the required causal connection between the substance,
regulation, and the harm;
(i) the probability of the harm (i.e., magnitude of the risk), and
(5) the type of risk subject to control (e.g., unreasonable risk).
Not every statute incorporates all of these aspects. And the terms us-ad
tend to overlap and be ambiguous, at times. (See Exhibit 8 where the key
terms are divided into three columns.) This will become clearer in the
following discussion. Distinguishing these aspects for the purpose of
comparative analysis is an exercise in semantics and legal interpretation that
may appear confusing. However, statutory inconsistencies in defining risks
prevent a simpler approach.
Before proceeding further, a short example may be helpful. under section
211 of the Clean Air Act, fuels and fuel additives can be regulated whose
emission products
(1) cause or contribute to air pollution which
(2) aay reasonably be anticipated to
(3) endanger
(<*) public health or welfare.
The phrase "cause or contribute" relates to the causal role or connection
which must be shewn between the pollutant and the harm. The phrase "may rea-
sonably be anticipated" refers to the degree of certainty required. The term
"endanger" describes the risk, particularly the magnitude of the risk.13-
The harm, presumably, is danger to the public health or welfare.
13j Ri.sk = (probably of harm) x (magnitude of harm).
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-50-
A differ sat approach is taken for toxic effluents under r.lie Clean Water
kct, Section 207 fa). There, EPA is authorized to regulars pollutants which
'will" (not oiay) 'cause" enumerated haras (death, disease, etc.) on tne
rsasis or ava:._ac.e uirsraation. -:iis rorauiation seems to require a stronger
causal connection between pollution and harm than the Clean A:.r Act approach,
and seens to allow less subjectivity than the "aay reasonably be anticipated"
femulation. lkj
Ir. the following pages we analyze the statutory language relating to
these issues. As shown by Exhibit 3, statutory language may be divided into
three categories. Therefore, tne analysis consists of three parts:
(-) Tyoe of harm involved, which is more or less explicitly
described in the statute and/or subsumed under risk tens;
'-) T-v-pe of risk involved, which includes borh the magnitude
(i.e., probability) of the risk as well as the type of
risk subject to control (e.g., unreasonable risk);
(2) Recuired nexus or connecticn between the substance,
regulation, ana the harm or risk involved, which is
described by statutory teras relating to probability,
uncertainty, and causality (or effectiveness).
It should be repeated that all of these legal specifications contribute
to the regulatory authority which an agency can exercise.
"""•"PE 0~ HARM
The harm component of a statute's risk definition generally consists of:
(1) descriptions of undesired outcomes, and/or
(2) descriptions of the "population at risk" or the objects of
protection including the environment, etc.
Thus, "harm" from toxics consists of one or the other or both of the above
components. Something happens to someone or something--that's harm. The first
component of hars uses such teras as "danger," "injury," "cancer," "death"
"adverse effect" but also includes mere "presence" (or discharge). Popula-
tions at risk include the "public," "wildlife," and the "environment". Some
statutes, like SDWA §§1401, 1412 have both outcome and population at risk
terms; other srarutes have one or the other.
'*- However, the pkrase referring to "available inforraation" in Section
207(a) acts to temper the certainty requirements somewhat.
-------
•31
The definition of ham is generally the clearest aspect cf 2 statute's
cefinition of risk. Harm represents the outcome which the statute is designed
to prevent. See Exhibit 9. As shown., harm statements range from "adverse
effects on public health and welfare," to recitations of health effects (e.g.,
"serious irreversible disease"), to less specified harms such as "pollution"
(Clean Water Act). No entries are included in Exhibit 9 for statutes wr.ich
contain no specification of harm.
One important distinction needs to be made when analyzing the issue of
'"nara". The severity of health impacts has both an individual and a collective
sice. Although some legislation, such as the GSK Act, is written tc afford
protection to every single working individual, aost laws are concerned about
aggregate effects on public health. Thus, harm should be understood, in this
context, as harm to populations. Of course, populations are composed of
individuals who may have varying sensitivities to toxic exposures;
nevertheless, unless there is a specially sensitive and/or large subgroup that
can be identified, regulatory standards oust be crafted to protect the general
public from harm. Such standards may not necessarily ensure the protection of
every individual in the exposed population.
Whether a substance regulated under one statute can be regulated under
another, vill depend in part on the required showing of hart;. Exhibit 10
focuses on human health impacts, illustratively ranking them top to bottom
from most serious and specific down to the most general and diffuse effects.
Thus, a substance meeting a specific health effects criterion, ail other
things being equal, will probably satisfy all the criteria listed lower in
Exhibit 10. The lower ones are more "inclusive". However, this ranking vculc
hardly be dispositive in a litigation context.
Note that such terms as "adversely affect," "significant adverse impact,"
and "any adverse effect" may be functionally equivalent. Note also that it is
difficult to assign a rank to the "unreasonable risk." formulation of the
HMTA. In fact, TSCA is similarly ambivalent: is it supposed to protect
against "injury to public health" or "unreasonable risks of injury to public
health"? (Definitions of the risk that use a separate "risk of" tera
modifying the outcome are considered separately in the "Type of Risk"
discussion.)
TY?E CF RISK
As shown by Exhibit 11, a number of statutes incorporate the concepts cf
risk, danger, or hazard in their definition of regulatory authority. Thus,
these terms need some analysis. Again, no entries are included in the Exhibit
and this discussion where statutes do not incorporate risk language.
At the start, it is helpful to point out that the term "risk" refers bctn
(1) to the probability of some outcome (harm) occurring, and (2) to the
probability of harm as well as its magnitude or severity. In general, the
-------
-52-
EXHI3IT 9
STATuTORY DESCRIPTION OP THE HARM
Statute
TSCA §4(a):
TSCA §4(£):
TSCA §§5(b)(4)(A),
5(f), 6(a)
CWA §311(b)(2)(A)
CVA §311(b)(i)
CrfA 307(a)
SDWA §1401(1),
§1412(b)(l)(B)
SDWA §1421
i
«PRSA §102(a)
RCSA §1004(5)
Description of Harm and/or Objects of Protection.
"Injury to health or the environment"
OR
"Significant or Substantial Human Exposure"
"Serious, widespread aara" to "hunan beings'1 from
"cancer, gene mutations, or birth defects"
"Injury to health or the anvirc-nment"
"[iaminent and substantial danger to] the public health
or welfare, including, but not limited to, fish, shell-
fish, wildlife, shorelines, and beaches."
"[harmful to] the public health or welfare . . . includ-
ing, but not limited to, fish, shellfish, wildlife, and
public and private property, shorelines, and beaches."
"Death, disease, behavioral abnormalities, cancer,
mutations, physiological nalfunctions, including mal-
functions in reproduction, or physical daforraations in
any organisms or their offspring."
"anv adverse effect on the health of oersons '
"the presence of any contaminant"
"affect adversely the health of persons"
"unreasonably degrade or endanger human health,
welfare, or amenities, or the marine environment,
ecological systems, or economic potentialities"
"an increase in mortality" or "in serious irreversible,
or incapacitating reversible, illness."
OR
"[substantial hazard] to human health or the
environment"
-------
3 •"•"I*' O
RCSA §§3002,3,4
?:r3A 223CC), 3(d),
6(b)
FIFRA §§25(c)
CAA J3108, 111, 157,
2C2, 211, 231
CAA §109
*~ ^ i s "* "• *
aA _.*.
CAA 2157
CIRCLA §102
CZRCLA §104
CSHA §6(b)(5)
•CfTA §104
FDCA §§406, 408
FDCA §§402, 601
•OJ-
EXHIBIT 9 (Continued)
STATUTORY DESCRIPTION OF THE HARM
1 Description cf Hara and/or Objects cf ?ro-ec^ior.
| "[protect] human, health and the envirsmnent"
i
| "unreasonable adverse effects on the environment" or
I "any unreasonable adverse effect en trie environment"
!
i "Serious injury or illness to children and adults
I resulting from accidental ingestion or contact."
| "endanger public health or welfare'1
"[orotect] the public health"
I
| "increase in mortality or serious irreversible, or
| incapacitating reversible, illness."
I
| "adverse effects on the stratosphere, especially
i ozone"
!
| "[substantial danger to] the public health or
| welfare or the environment"
I
| "death, disease, behavioral abnormalities, cancer,
' genetic mutation, physiological malfunction (includ-
| ing malfunctions in reproduction) in ... organisms
| or their offspring"
I
| "no . . . material impairment of health or functional
i capacity"
i
| "[unreasonable risk to] health and saferr or property"
i
] "[protect] the public health"
I
I "injurious to health"
H3CA §§409(c), 512,
706(b)
cancer in man or annna.
-------
-54-
EXHI3I7 9 (Continued)
STATUTORY DESCRIPTION OF THE HARM
Statute I Description of Harm and/or Obi acts of Protection
PWSA 33 USG §1223 j "vessel or cargo loss, or damage to life, prop«rty,
i the marine environment ... to structures in, on,
| or immediately adjacent to the navigable water;; or
! the resources within such waters"
I
PWSA 33 USC §1225 | "damage to, or the destruction of, any bridge . . .
| [harm to] the navigable waters and the resources
| therein"
I
3FCIA 33 USC §391a | "hazards to lifa and property, for navigation and
| vessel safety, and for enhanced protection of the
I marine environment."
i
CPSA §§7,3 I "[unreasonable risk of] injury" defined as "death,
I personal injury, or serious or frequent illness."
I '
FHSA §§2(f), 3(a) | "substantial personal injury or serious illness"
I
FHSA §§3Cb), 2(q) | "[protect] the public health and safety"
I
PPPA §3 | "serious personal injury or serious illness"
| affecting" "children"
I
FFA §4 | "fire leading to death or personal injury, or
j significant property damage"
i '
me 42 USC §2201 Cb) | "protect health" or "miiiiaiize danger to life
| or property"
I
NRG 42 USC §§2077(d), | "unreasonable risk to the health and safety of
2111 1 the public"
-------
serious widespread harm from cancer, gene nni*a~ions, or birth defec.s
[TSCA §i(£5]
dearh, disease, behavioral abnormalities, cancer, oiura-icns, paysiclogical
malfunctions, physical deforaarions, birrb. aefacts
[CERCLA SlOi, CVA §307(a)]
[increase in] mortality, serious irreversible, or incapacitating
reversible, illness
[RCRA 100i(5), CAA §112]
serious injury or [serious] illness
[FITRA §25(c), ?PPA §1471]
adversely affect the health
[SDWA §1421]
significant adverse impact on life
[NRC]
any adverse effect
[SDVA §21401, 1412]
no material impairment
[OSHA §6(b)1
imminent and substantial danger
[CVA §211(b)(2)(A)]
danger to or endanger public health
[CAA §§108, 111, 157, 202, 211, 231, CERCLA §102]
unreasonable adverse effects or any unreasonable adverse effect
[FlrRA]
[unreasonable risk of] injury to health
[TSCA §4(a), §5, §6]
[unreasonable risk] to health
[SfTA]
-------
-56-
ZXHI3IT 11
SPECIAL TYPES OF RISK INCORPORATED IN STATUTORY SEJINITTCNS
Tvae of Risk
"significant risk"
"substanti
"endanger"
substantial danger'
"danger"
"imminent and substantial danger"
"substantial present or potential hazard
"unreasonable and substantial risk"
"unreasonably degrade or endanger"
"unreasonable risk"
"unreasonable risk"
"unreasonable risk"
"unreasonable risk"
"unreasonable risk"
Statute
! T3CA §4(f)
I
i CZ2CLA §102
I
I CAA §§108(a), lll(b), 1570s),
I 202(a), 211, Z31
I
i AEA 42 USC §220l(b)
! CWA §311(b)(2)(A)
I
! RCXA §1004(3)
j
i 5TICA (med. dev.)
!
I
i MPRSA §102(a)
I
| TSCA §4(a), §.:(b)(i)(A), §5Cf
I §6(4)
t
I
| CPSA 15 USC §32056, 2057
I
KJfTA §104
JIFSA §§3, 6
AEA 42 USC §§2077(d), 2111
-------
first meaning applies when the statutory language reads "risk of "
followed by a definition of a harm, or when the term "risk" is preceded, by
such words as "significant" or "substantial". However, when "risk" is
modified by the word "unreasonable," it usually refers both to probability as
well as severity of harm, as do the terms "danger" or "endanger."
Many of the risk terms appearing in statutes have modifiers such as .
"significant," "substantial," or "unreasonable". With the exception of the
term "unreasonable," the other modifiers all refer exclusively to the
magnitude or probability of the risk.15-1 This is how the Supreme Court
used the phrase "significant risk" in its benzene decision.'"' There is nc
standard legal definition for ranking the terms significant and substantial;
therefore, both terms should be considered equivalent.
The following sections discuss the concepts of (1) probability of harm
embodied in the terms "significant" or "substantial" risk, (2) "endanger" cr
"danger," and (3) "unreasonable risk".
Probability of Harm. As the probability of harm presented by a toxic
chemical exposure approaches zero, the risk may be deemed "insignificant" for
purpose of designation and regulation. Conversely, as the probability
increases, more strict regulatory standards may become appropriate. Thus, an
essential component of a statute's definition of regulatable risk is the
probabilty of harm criterion.
Most statutes do not directly address this aspect of risk but subsume it
under such rubrics as "endanger the public health" or "presents an unreasonable
risk". These approaches do require consideration of the probability of harm
together with other risk factors (i.e., severity of harm, in the case of the
'endanger" standard) and in view of compliance costs (in the case of
"unreasonable" risk). These situations are discussed later. Certain
statutory provisions do, however, incorporate terms 'usually interpreted as
referring solely to the probability of harm. Thus, such phrases as
"significant risk"- or "substantial risk" imply that low probability risks are
not subject to regulation. This is how the Supreme Court used the term
"significant risk" in its benzene decision. However, it should be clear that
even these phrases are somewhat ambiguous semantically since a low probability
of a catastrophic event may still constitute a significant or substantial risk.
1S-"Imminent", risks refer to the velocity of the threat as epposec to
its magnitude.
itj IrCD v. API. i48 U.S. 607 (1980) (plurality opinion). See also
Linet and Bailey, 'Benzene, Leukemia, and the Supreme Court," 2 Journal
Public Health Policy 116 (June 1981).
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in its recent benzene decision, the Supreme Court noted seme possible
parameters to tha tarm significant: risk. The Court explained that if the odds
ara one in a billion that a person will die from cancar by taking a drink of
chlorinated water, the risk "clearly could not be considered significant." On
the other hand, "if the odds are one in a thousand that regular inhalation of
gasoline vapors containing 2% benzene will be fatal, the risk could raascnably
be considered significant." The Court, however, leaves, a w.ide gray zone.
between .001 and .000000001. Most toxic substances risks will probably rail
right in this gray zone.
• Far example, under the Clean Water Act, the EPA determines
the quantities of hazardous polluting substances which :aay
be harmful to she public health and environment if spilled
into the waters. The SPA accomplishes this using a worst
case scenario combined with a significance factor of
one-Ln-a-million risk of fatal cancer.17-1
Although the terms significant and substantial refer to the magnitude of
the risk, the taras have not been defined quantitatively, either in the
relevant statutes or in the case law. There has been very little judicial
interpretation of these terms and, in any event, agancy determinations of
significant or substantial risk are likely to be accorded judicial deferanca.
The Meaning of "Endanger". Most appcsita is the definition used bv
Judge Wright cf the D.C. Circuit Court of Appeals reviewing the former "will
andanger" standard of the Clean Air Act:
Danger is not set by a fixed probability of harm, but rather is
composed of reciprocal elements of risk and harm, or
probability and severity. That is to say, the public health
may properly be found endangered both by a lesser risk of a
greater harm and by a greater risk of a lassar harm. Danger
depends upon the relation between the risk and harm presented
by each case and cannot legitimately be pegged to "probable"
harm, regardless of whether that harm be great or small.l'J
; 7- The Supreme Court's opinions aay encourage some legal challenge to
this methodology.. Conversely, agency regulations may be challenged as
inadequate if they do not reduce the significant risk to at least a on* in a
billion chance of fatality.
l>- Ethyl Coro. v. SPA. 541 ?. 2d 1, 31-3 (D.C. Cir. 1976) (an baric)
(citations emitted) see also 38 FR 33734.
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Judg-e Wright held that the EPA had been correct in interpreting will
jndanger" to mean "presents a sigr.ificant risk cf harm."13- As -he Judge
put it:
. . . endanger means something less than actual harm. When one
is endangered, harm is threatened; no actual injurv need ever
occur.21-
The concept of "danger" was contrasted, in Ethyl, with the concept of
''adverse effects"; the former was considered precautionary while the latter
requires a showing of actual hara.:ij
The 3th Circuit Court of Appeals similarly interpreted the term
"endangering" as it appeared in the Clean Water Act of 1970 (§112):
[We] believe that Congress used the term "endangering" in a
precautionary or preventive sense and, therefore, evidence of
potential harm as well as actual harm comes within the purview
of that term.1JJ
How probable must the occurrence of a threatened harm be for it to
constitute a danger or hazard? And how severe? As noted by the Ethyl Court,
a "sophisticated case-by-case analysis is appropriate".11- That is because
danger is composed of reciprocal elements of risk (i.e., probability) and
harm. The magnitude cf the risk sufficient to justify regulation is inversely
prcpcrtional to the harm to be avoided.
This suggests that there are minimal risk and harm levels that must be
met for a "danger" to be present. For example,
• even the absolute certainty of de minimus (i.e.,
minor) harm might not jusify government action.2k-
:'- Ibid, at p. 12.
*'J Ibid'
'••- Ibid., at 15.
"- Reserve fining Co. v. EPA, 514 F.2d 492, 528 (8th Cir. 1575) (en
bane).
:3" S-hyl, ££• ci-•• at 1S-
:"- Ethvl at D. IS.
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• the possibility of a disaster of "ultimate severity
horrible consequences" may be so low as to allow minimal
consideration and response.15j
With respect to harm, cancer and lead poisoning, would clearly not be
considered de minimus. With respect to probability of occurrence, the legal
requirement seems to be a "significant risk".iij Because of the reciprocal
relationship between risk and harm, the exercise of judgement is unavoidable
and implicit in determinations of danger.Z7J
Danger is a risk, and so cuust be decided by assessment of risks as
well as by proof of facts. . . ,11-1
This requires weighing the relative risks of underprotection versus
overprotecti.cn. An analogous balancing act is required whenever the term
"unreasonable risk" appears in a statute; these situations are discussed next.
"Unreasonable" Risks and Effects
The term of art "unreasonable" appears in several statutes, either
preceeding the word "risk" or modifying "adverse effects". The former usage
appears in many sections of TSCA; the latter usage is prominent in ~"3A. The
two phrases are equated by FIFRA which statutorily defines the latter in terms
of the former. The MPRSA also uses the term "unreasonably" and other non-£?A
statutes such as the Consumer Product Safety Act, and the Flammable Fabrics
Act, employ unreasonable risk as a statutory criterion.
The term is derived from the law of products liability where recovery for
injuries is predicated on a finding that the product in question is "unreason-
ably dangerous" to the consumer during ordinary or proper use. The ccurts
have elaborated this legal doctrine quite extensively but the essence is that
the utility of the product oust be weighed against the magnitude of the danger.
In interpreting the Consumer Product Safety Act, the Court of Appeals for
the Fifth Circuit held that the reasonableness of the risk is a function of
2SJ See Carolina Environmental Study Group v. U.S., 510 F.2d 796, 799
(B.C. Cir. 1973).
2SJ See Ethyl at p. 20; Industrial Cnion Peat, v. American Petro-
leum Institute 443 U.S. 607 (1980) (benzene).
P- 20; Amoco Oil Co. v. £?A, SOI F.2d at 740-1 (D.C.
v. Hodgson, 499 F.2d 467, 473 (D.C. Cir. 1974) (asbestos).
2IJ Ethvl, at p. 2
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the burden the standard would impose.2!j The burden includes both technical
aspects (decreased utility, use of substitutes) as well as economic impacts.
- Neither TSCA, "IFHA, nor the C?SA define the term "unreasonable risk".
This was the congressional intent, as documented in the legislative histories
of these laws. However, Congress was not otherwise totally silent:
[T]he determination of unreasonable risk involves a considera-
tion of probability, severity, and similar factors which cannot
be defined in precise terms and is not a. factual determination
but rather requires the exercise of judgement on the part of
the person making it. ... [Legislative History of TSCA, pp.
More specifically, the legislative history of TSCA indicated what factors
should generally be weighed in making the determination that an unreasonable
risk exists or may exist. Such a determination involves
balancing the probability that harm will occur and the magni-
tude and severity of that harm against the effect of proposed
regulatory action on the availability to society of the
benefits of the substance or mixture, taking into account the
availability of substitutes for the substance or mixture which
do not require regulations and other adverse effects which such
proposed action may have on society. [Legislative History, p.
i22~. ]
Similarly, Congress expressly omitted any definition of "unreasonable
risk" from the Consumer Product Safety Act, stating
Protection against unreasonable risks is central to many "ederal
and State safety statutes and the courts have had broad experi-
ence in interpreting the term's meaning and application. It is
generally expected that the determination of unreasonable
hazard will involve the Commission in balancing the probability
that the risk will result in harm and the gravity of such harm
against the effect on the product's utility, cost and
availability to the consumer. An unreasonable hazard is
clearly one which can be prevented or reduced without affecting
the product's utility, cost or availability: or one which the
effect on the product's utility, cost or availability is
outweighed by the need to protect the public from the hazard
associated with the oroduct.58J
Z>J Acua Slide 'N' Dive v. CPSC. 569 ?.2d 331 (5th Cir. 1975).
"J H.E. Rep. No. 1133, 92nd Cong., 2d Sess. 33 (1972).
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.ais suggests a. centra, ro.e for cost-benefit analysis which is belied by
tne CPSr-'s legislative history:
There should be no implication, however, that in arriving at
its determination the Commission would be required to conduct
and complete a cost-benefit analysis prior to promulgating
standards under this act.Jl-
The legislative history of TSCA indicates a similar Congressional point of
view.
Although FI7RA does not define the term "unreasonable risk" it indicates
that economic, social, and environmental costs and benefits of the use of
pesticides are to be taken into account. This requires a cost-benefit typu of
an analysis.
THE REQUIRED N~XUS OR CONNECTION: CERTAINTY,.CAUSALITY.. ETTZCTIVINZSa
In order to justify the regulation of a chemiial substance (or activity
involving that substance), there must be a regulatory rationale. That
rationale is typically based on some connection between (1) the chemical
substance and a harm to be prevented or (2) the regulatory standard and
protection. Without such a connection, a regulation would probably be dee.ned
invalid.:IJ '
Even if a documented public health, problem exists (i.e., if the type of
harm criterion is satisfied), no regulation in response to this problem would
be justified unless it can be shown:
• That an identifiable chemical subs-ranee or mixture is
probably associated with the adverse effects, and
• The proposed standard would result in a decrease of
negative effects.
The first point is essential to substantiate a designation decision. The
second point is essential for regulation.
J:- Legislative History, see note 30, Ibid.
3I-The Sirpreae Court's benzene decision suggests that risk reduction
must result from the imposition of a regulatory standard; without
cemcnstrable resultant benefits, a health regulation has no rationale.
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There are three distensions to the connection requirement:
(1) Statutory Language relating to the resolution of uncer-
tainty regarding the causal rola of t.ie suspect cr.ea.ical
and the danger it poses (e.g., "may" hara vs. "will" hara);
(2) Statutory language relating to the causal role and
probability of hara associated with a chemical exposure
(e.g., "present1, "cause", "contribute"); and
(2) Effectiveness Language circumscribing agency discretion
in fashioning standards (e.g., "necessary or appropriate"
standards).
Three classes of statutory language are most pertinent to satisfying any
rational nexus or connection requirement. Rules which do not adequately
address these issues are subject to judicial invalidation as not seating
statutory criteria or as irrational and arbitrary exercises of administrative
power.
Certainty
auostance
or iii.ii Connection? • • • ' - • - riara cr
Standard Protection
A A
Probability Causality
The statutes reviewed employ different phrases to connect the pollutants
with the hara or risk of harm to be avoided. For example, the Toxic
Substances Control Act employs a variety of different phrases connecting
substances and activities to "unreasonable risks":
"may present" Section 4(a), 3(e)
"presents or say present" Section 5(b)
"presents" Section 7(a), Sfa)
"presents or will present" Section 4(f), 5(f), 6(3)
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• exposure] occurs or
may reasonably be
ariTi.cips.~ec [re occur!" Sec-ion 5(e)
"likely to result" Section 6(d)C)
Section 6(e)
These terms relate to the resolution of uncertainty, probability of harm,
and the causal role required for agency action. Other phrases (e.g.,
''necessary to protect the public health") relate to the connection required
between the stancard and the harm. See Exhibit 12. These topics and
statutory language are discussed in detail next, except for probability of
harm which has already been considered.
Resolution of Uncertainty
The legislative histories of most of the statutes reviewed recognize that
the regulation of health and safety risks cannot usually be based on straight-
forward, definitive factual analyses. Rather, agencies will need to resolve
uncertainties about the risks posed by particular substances. The statutes
provide some guidance about this issue in a number of ways:
• The definition of the risk often incorporates a
certainty requirement (e.g., "may present" an
unreasonable risk versus "will present" an unreasonable
risk).
• The factors for making a designation or regulation
decision may address uncertainty through such a phrase as
"best available evidence". Available evidence is usually
not unambiguous.
• Burden of proof or evidentiary requirement? (e.g.,
substantial evidence) determine who is responsible for
resolving how much uncertainty.
• Finally, authority to designate or regulate chemicals
categorically (as opposed to substance-by-substance) cr
to provide a margin of safety may implicitly affect, burden
of proof and allow for relatively more uncertainty to be
tolerated.
Clearly, the resolution of uncertainty is an issue that permeates any
analysis cf statutory authority to designate and regulate chemical substances.
Uncertainty can attach to all aspects of the definition of risk, including the
probability and severity of the out-come, the population at risk, and. the
causal connection. Each of these four elements of risk is subject to
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3ET*ZZN
EXHIBIT 12
TY?SS OF CAUSAL CONNECTIONS REQUIRED
CHEMICAL SUBSTANCES OR STANDARDS AND C21 RI3X 0? HAR.1
Causal Connection
Statute
Group 1--Present Conditionals Us lag "May"
"nay reasonably be anticipated to affect" | CAA §157
1
"may reasonably be anticipated to endanger" | CAA §§108, 111, 137, 2C2(a), 211,
! 231
'"may reasonably be anticipated to result"
"may be hararai to"
"nay present [danger or risk]"
"say render [food injurious]"
"may make [product injurious]"
"may generally cause"
"may cause"
"may result in"
"may have [any adverse effect]"
"may affect [adversely]"
CAA §112
CVA §311(b)(4)
TSCA §4(a), CZ2CLA §102
FDCA §§4Q2(a), 501
USDA (?PIA, ?MIA, and IPIA)
FIIHA §§3(d)(l)
FHSA §2(f), 3(a)
SDWA §§1421
SDWA §§1401, 1412
i SDWA §1421
Group 2--?reser.r Tense Unconditional
"causes or contributes to" | CAA §§108, 111, 112, 2C2, 211, 231
"presents [danger or risk]" | CWA §311(b)(2)(A), C?SA §3
j
"generally causes" i 7ITRA §6(b)
I
"[is] associated with" \ C?SA §8
I
"presents or will present" | TSCA §§4(f), 5(b)(4)(A), 3(f), 6(a)
ordinarily render[s]'
i 7DCA §402(a), USDA (??IA, FMIA,
; and £?IA)
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ZXKIBIT 12 (Continued)
TTF-ZS OF CAUSAL CONNECTIONS REQUIRED
IVZZN 'T CHEMICAL SUBSTANCES 3R STANDARDS AND ^2) RISK 0? HARM
Causal Connection Statute
Group 3--Future Tense Unconditional
"will or say reasonably be anticipated j
to cause" ' " \ CZRCLA §10A
I
"will not generally cause" j FI.FRA §§3(c)(5), 3(d)
will not [unreasonaaiy aegraae |
or endanger]" I FIFRA §3(c)(5)
I
"will cause" ] CVA §307(a)
I
"will not cause" i FIFRA §3(c)C7)(C)
I
"would not cause" I FIFRA §3(d)(3)
I
"would net significantly increase |
fthe risk of]" i FIFRA §3(c)(7)(A),(3)
i
"would not constitute: i AZA 42 USC §2077(d)
Group 4--Causal Connection Between Standard and Kara
"in order to protect against" FIFRA §25(c)
"is necessarv to orevent" i FIFRA §3(d)(2)
I
"is necessary t= protect" | PWSA §1225
i
"is required to protect" ?PPA §3
I
"if recurred to assure" . | FDCA §409
I
"necessary to protect" | FDCA §§406, 408; FHSA §3(c)
I
"necessary or appropriate" i HKTA §105, OSHA §3(8)
I
"aay be necessary" USCG (BFCLA and DCA)
"is reasonably necessary" j CPSA §7
"nay be" or "is" "needed to protect" ; FFA §4
"necessary or desirable" AZA 42 USC §2201(V,
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generaily imprecise estimation based on extrapolations from scientific studies
or other data. Each estimate, moreover, should be thought of as "scst likely"
with confidence limits describing the probable range of the astiaata.
Population at risk, probability and severity of harm ara three variables
which effectively set the bounds on what is a public health problem for which
regulation might be necessary or appropriate.
In many instances, the limited available data can support alternative and
•incompatible "scientific" interpretations. For these situations, these
elements cannot be determined based on "facts" but become "judgment'' calls.
These "policy judgments," as they are also called, ara usually within agency
discretion so long as they are not "arbitrary or capricious'1 (i.e., without
rational foundation). In those situations, much regulatory discretion will
axist to resolve uncertainty.
For example, an agency might estimate that of avery 1,000 people axpcsed
to a substance, three might be "reasonably expected to" contract fatal cancar.
However, the 95 percent confidence interval33J on this incidence estimate
might range from one to 100, or from one to 10 if there were lass uncertainty.
The same reasoning applies to estimates of the population at risk. Both of
these risk variables ara measured using cardinal scales which are quite
amenable to numerical calculations of uncertainty.
Uncertainty regarding the severity of harm must be treated diffarantly.
In some instances, the severity of the harm is quite certain, in others lass
so. Quite often, the possible harms do not form a continuum and ara thus net
well-suited to conventional numerical confidence limits. For example, among
the health effects of benzene exposure are leukemia, aplastic anemia Coften
fatal), various cytopenias, and sufaclinical chromosomal aberrations. Statutes
using relatively broad harm concepts (e.g., endanger public health) would seem
to permit more uncertainty regarding severity of effects than statutes
defining more precise types of outcomes (see Exhibit 11).
Finally, uncertainty regarding causality needs to be distinguished from
uncertainty regarding probability. For example, in the case of coka oven
emissions, the probability and severity of health affects ara both relatively
certain; what is not known is the specific causal agent or chemical
substance. Conversely, the issue of causality may become moot when, both the
probability and severity of health effects are highly uncertain but expected
to be low. In other cases, CJCs for example, control standards may be
grounded in a very confident causal role assessment (i.e., stratospheric
effects), although the probability and severity of health impacts are less
certain.
3'•'This is a standard statistical measure of uncertaintv.
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r.a---
Ststutcry language referring to uncertainty is ambiguous. For example,
the ters "aay" as in "may cause" or "may endanger" has two possible interpre-
tations. "May" might refer either to (1) the probability of public health
impacts or to (2) some uncertainty regarding the risk. Conversely, the
expression "will," as in "will endanger," can refer either to high probability
or high levels of certainty. In either case, courts read statutory language
very closely and have found as deficient certain agency rules issued under a
''will cause'1 standard that would have probably been upheld under a "may cause"
standard. 3"-'
There are several legal cases and other authorities which explicitly
discuss the certainty/probability issue as embodied in the terms nay or will:
• MCA v. Cost la interpreted the terai "will be harmful"
wnich formerly appeared in Section 311 of the Clean Water
Act but was changed to "may" as a result of this
decision.3l-
* EDF v. Costle]iJ interprets the tern "may" in Section
1-*12 cf tne Safe Drinking Water Act
• Several cases interpret the "may render injurious"
standard of the Food, Drug, and Cosmetic Act, Section »02.
• The legislative history of TSCA discusses the
Congressional intent in using "may" in TSCA Section 4(a).
• The legislative history of CZRCLA compares the use of
"may" in CZRCLA Section 1C2 to the unconditional language in
the designation criteria of CVA Section 311(b)(2).
All cf these authorities suggest that the term "may" allows for more
agency discretion on designation and regulation than do other unconditional
terms.
For example, EPA's designation of reportable quantities under the former
wording of Section 311(b)(4) (i.e., quantities which "will be harmful" at
3iJ See, MCA v. Costle, 455 F.Supp. 968 (V.D. La. 1978).
JSJ See "Clean Water Act Regulatory Review" in 1C? Incorporated,
:heffiieal Substances Designation, Volume 2 (1981).
"- IDF v. Costle. 578 F.2d 237 (D.C. Cir. 1978).
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"such times, location, circumstances, and conditions" when discharged) was
invalidated as arbitrary and capricious because no demonstration was made
linking actual harm to reportabla quantities. Section 311(b)(4) was amended,
following the decision, to allow EPA to determine those quantities of
hazardous substances "which may be harmful" and these rules have not been
legally challenged.
The Safe Drinking Water Act (SDWA) requires regulation of contanm.ar.t3
which "may have an adverse effect on health." The D.C. Court of Appeals, in
generally upholding the interim regulations issued by the EPA, cited the
.legislative history of the SUVA which authorizes EPA to regulate contaminants
despite potential uncertainty'about health effects:
The words used by the Committee were carefully chosen. Because
of the essentially preventive purpose of the legislation, the
vast number of contaminants which may need to be regulated and
the limited amount of knowledge presently available on the
health effects of various contaminants in drinking water, the
Committee did not intend to require conclusive proof that any
contaminant will cause adverse health effects as a condition
for regulation of a suspect contaminant. Rather, ail that is
required is that the administrator make a reasoned and
plausible judgment that a contaminant say have such an
effect.37^
"May render injurious" is a criterion for determining whether a substance
that is added to food makes that food "adulterated" under Section 4C2(a) of
the Food, Drug, and Cosmetic Act. Several courts, including the U.S. Supreme
Court have interpreted that phrase to mean that the Government need not prove
conclusively that a food containing an added poison aust cause injury.31'
Rather, if the food
"cannot fay any possibility, when the facts are reasonably
considered, injure the health of any consumer", the statutory
criterion is not met.3*-1
37J EDF v. Costle, 573 ?.2d 327, 11 ESC 1209 (D.C. Cir. 1978), citinj
H.S. Rep. No. 93-1185, 92d Cong., 2d Sess. (1974) at p. 10 (emphasis in
original).
1IJ U.S. v. Lexington Mill and Elevator Co., 232 U.S. 399 (1914)
(flour treated with nitrogen peroxide gas).
3'J Ibid., at 411.
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Anotzier court has pointed out that
The word "aay" connotes a reasonable possibility. It does not
mean that a food may be prohibited absent absolute certainty
that no one under the most extreme circumstances could be
harmed. Nothing in the Act or legislative history suggests
that Congress intended to proscribe a food simply because it
was physically possible for one to consume enough of it to harm
oneself. The Supreme Court has taken notice that a person
could be harmed by ingesting a certain level of table salt, or
even water.*°-
This formula has been applied by other courts which have cast the require-
ment as a finding whether the food poses "a reasonable possibility of inju:ry to
anyone's health."*1-1 This type of determination should consider the various
ways the food might be used, as well as the special sensitivities of such
groups as the sick, the young, or the aged.1*1-1 Thus, the "may render
injurious" language of the FDCA requires a showing of lesser probability o:r
certainty of harm than a "will render" criterion and also allows an agency to
consider effects on especially vulnerable segments of the population.k3J
The criterion necessary to trigger Agency action under Section 4(a)(l)(A)
(i.e., test rules) of TSCA is "may present" an unreasonable risk. The
legislative history states that this criterion is intended:
"to focus the Administrator's attention on those chemical sub-
stances and mixtures about which there is a basis for concern,
but about which there is inadequate information to reasonably
predict or determine the effects of the substance or mixture on
health or the environment. The Administrator need not show
that the substance or mixture does cr will present a risk."
[Legislative History, p. 674. (emphasis added)]
kCjl U.S. v. Anderson Seafoods, Inc., 447 7. Supp. 1151, 1155 (Is'.D. Fla.
1S7S), citing Flearning v. Florida Citrus Exchange. 358 U.S. 153, 163 (1958).
*1J See, U.S. v. Anderson Seafoods Inc., 447 F.Supp. 1151, 1156 (N.D.
Fla. 1978); Berger v. U.S. . 200 F.2d 816, 821 (8th Cir". 1952) (dicta).
tij See; Lexington Mill at p. 411, See also Wood v. U.S., 286 F.84
(7th Cir. 1923), where soda was not found to be adulterated because one would
ha-ve to consume 150,000 bottles to achieve a "dose" of arsenic.
4:- See, Merrill and Schewel, "TDA Regulations of Environmental Contaa-
inants in Food," 66 Va. L. Rev. 1357, 1272 (1980); but see, Environmental
Standards and Sensitive Populations (Conservation Foundation, 1981).
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The House Report also discusses the choice of the tarn "may".
It should be noted "hat the bill does not require the Administrator
to find that a. substance or mixture does cause or significantly
contribute to or will cause or significantly contribute to an
unreasonable risk. Such a finding requirement would defeat,the
purpose of the section, for if the Administrator is able to make
such a determination, regulatory action to protect against the risk,
not additional testing, is called for. However, the tann "may" as
used in the phrase "may cause or significantly contribute to" does
not perait the Administrator to make a finding respecting
probability of a risk on the basis of mere conjecture or
speculation, i.e., it may or may not cause a risk. [Legislative
History pp. 424-5.]
Thus, use of the conditional cars "may" permits a fairly broad axercise
of agency discretion,, although it does not allow arbitrary decisions.
Designation criteria for CE3CLA Section 102 hazardous substances includes
the phrase "may present substantial danger" which was characterized as
requiring a "lower threshold for designation" than that induced in the
designation criteria of CWA Section 311(b)(2) hazardous substances (.i.e.,
"present an imminent and substantial danger"). In reference to the earlier
Senate version of CZ3CLA, 5.1430, Congressional intent in defining Section 102
hazardous substances was "to afford ... broad discretion in designating
substances."
In. summary, any analysis of regulatory integration must take into account
statutory requirements or authorizations relating to the issue of
uncertainty. As discussed earlier, the definition of risk will, in particular
cases, incorporate a position on uncertainty, but other statutory provisions
(e.g., decision factors or criteria, burden of proof provisions) also need to
be considered. In the next section, we further discuss the related topics of
probability and/or certainty of causation or protection.
The Causal Connection
There are a number of issues involved in the notion of causality. Two of
those issues are the focus of this discussion:
(1) Direct versus indirect causation, and
(2) Cumulative versus incremental causation as a basis for
regulation.
In discussing the first issue, we will review the statutory terms used
(e.g., "pose", "present", "render", "cause"). The second issue requires a
review of legal decisions that have considered the problem.
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Direct vs . -r.cirect Causation
Although some connection must be established between the presence of or
exposure to pollutants and potentially resulting health effects, the statutes
often use specific language that broadens the possible causal rcles for which
chemicals nay be subject to control. The intent behind the use of these terras
is to include both direct and indirect health effects.
There was much debate surrounding the proper connective to be used in
TSCA. Ultimately, though, the conference committee adopted the Senate
language aay "present" in lieu of the House formula may "cause or
signif icant iy contribute to". In choosing this term, the conferees .intended
that [EPA] ... be able to address substances and mixtures which
indirectly present unreasonable risks, as well as those which
directly present such risks. Further, the conferees do not intend
that a substance or mixture must be the single factor which results
in the presentation of the risk [Legislative History of TSCA, p.
673.]. '
Despite this, the terms used in the different laws are not consistent.
The acst -widely-used terms are:
cause or contribute to
"render"
"present"
cause"
"affect"
"result"
"pose"
RCRA 1004(5) (A); CAA §108, §111,
§202, §211, §231
7DCA §402(a), §601
TSCA §§4, 5, u 6 ; CVA
§211(b)(2)(A); CZRCLA §102; C?SA §8
CVA §307 (a); FIFRA §3, §6; CERCLA
§104, FHSA
SDWA §1421, CAA §157
SDWA §1421, CAA §112
RCRA §1004(5) (3), HMTA §104
Some phrases explicitly mention both direct and indirect effects (e.g. ,
CZRCLA §104). Other statutory provisions incorporate a two-stage causal
requirement (e.g., TSCA §4(a), SDWA §1421, CAA §108, §111, §157, §202, §211,
§231). See Exnibit 13. The Clean Air Act formulae were largely adopted in
1977 to clarify the bases of air pollution regulation. To regulate 'under
several sections, EPA must show that (1) emissions cause or contribute to air
pollution which (2) air pollution endangers the public health.
-------
-73-
Cumulative vs. Incremental Effects
Exposures to hazardous chemicals often have multiple sources. For
example, sources of lead include food, automotive emissions, industrial
pollution of air and water, etc. When assessing the health risks of a
substance such as lead, it is difficult--almost arbitrary in fact--to allocate
portions of the health damage to the different sources of the pollutant..
Despite this difficulty, statutory provisions usually authorize the regulation
of only one class of sources. Typically, legal controversy surrounds the
decision to regulate an exposure increment; affected industries often contend
that the exposure increment being regulated is not, in itself, hazardous;
agencies counter that cumulative impacts oust be considered and different
pollution sources may have varying degrees of susceptibility to control.
The 1977 Amendments to the Clean Air Act clarified this issue by using
the phrase "cause or contribute to air pollution which may reasonably be
anticipated to endanger" public health. This formulation allows consideration
of aggregate air pollution, impact, regardless o-f source (i.e., mobile vs.
stationary). Congress authorized EPA to consider all sources of exposure to
the pollutant--food, water, air, etc.--in determining health risk.
However, the Ethyl Court agreed with EPA's position that the
contribution must be "significant" before regulation is proper.-
Moreover, "while the incremental effect of lead emissions on
the total body burden is of no practical value in determining
whether health is endangered, it is of value, of course, in
deciding whether the lead exposure problem can be fruitfully
attacked through control of lead additives.'""'-'
However, the court did not agree that the increment of exposure itself
must cause a significant health hazard. This view is consistent with the case
of People of California v. Department of Navy"8-1 which held that "It is the
cumulative effect of innumerable 'insignificant' pollutions which has hung an
environmental cloud over our planet".ksj
An analogous controversy has arisen over the regulation of environmental
contaminants and additives in food. The Fifth Circuit Court of Appeals
rejected the contention that the added increment alone must render food
injurious for regulation to be necessitated; rather, regulation is called for
whenever the total amount of the pollutant may be injurious so long as some
fc*J Ethyl at p. 31, n. 62. See Wilkey, dissent, Ibid.. p. 94.
"-1 431 F. Supp. 1271 (N. D. Cal. 1977).
"*'' Ibid- • a" ?• 1294-
-------
-1U-
portion cf the contamination is attributable to acts of mar.."7'
pointed out that the increment of the contaminant must create or increase "a
potentiality of injury to health" and it need net, by itself, be shown to
render food potentially injurious.
Likewise, the use of the term "present" in TSCA reflects the intent to
£rant authority over this type of toxic exposure:
Oftentimes an unreasonable risk will be presented because of the
interrelationship or cumulative impact of a number of different
substances or mixtures. The conferees intend that the Admini-
strator have authority to protect health and the environment in
such situations. [Legislative History, pp. 673-4.]
Several of the provisions of the Food, Drug, and Cosmetic Act
specifically require the FDA, when setting tolerances, to consider the other
trays that consumers may be affected by the same or related hazardous
-heraicals. However, apart from past LRLG activities, there have been only
Linited attempts, in general, to integrate standard-setting across agencies or
among exposure sources to take multiple exposures into account. This remair.s
roi the most part an unexplored frontier for policy-related research.
?,;^Tt-TORY BASES AND FACTORS FOR LEVEL CF PROTECTION DECISIONS
The statutes reviewed often differ as to the amount of protection or risk
- fraction they authorize. Many statutes refer only to the issuance of stan-
.-- ds "necessary," "adequate" or "sufficient" to protect the public health.
'•'..fie give acre detailed guidance (e.g., ample margin of safety, no aaterial
airaent of health). Others address this issue by prescribing particular
•A' ;ors as the basis for standard-setting (or as matters for consideration).
•-his last group, many laws allow for the balancing of risk and cost
, -isideratisns, which is another way of establishing a level of protection.
..- Exhibit 13. These issues are discussed in this part of the analysis.
Statutory language often guides, the designation and standard-setting
process by explicitly providing a specified basis for making decisions as well
as factors to be considered. In discussing these issues, it is essential to
c:.«":inguish among:
• bases for decisions,
• factors which must be considered,
.5. v. Anderson Seafoods, Inc., 622 F. 20 157, 161-2 (5th Cir.
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" factors which gay be considered, and
* factors which may not be considered.
In ambiguous situations, the administrative process can take the lead in
interpreting legislative language, subject to review in the Courts or Congress.
In general, a substantial amount of agency discretion exists to 'read statutory
language in permissive fashion. Thus, while statutory directives must be
heeded, they can be interpreted creatively (e.g., EPA implementation of
section 112 of the Clean Air Act). However, explicit direct statutory
language is a major force in defining regulatory authority. Thus, it is ax.
"established max-ia that health-related legislation is liberally construed :.o
achieve its purpose. "fcl-i On the other hand, the same Court of Appeals has
written that "when Congress directs an agency to consider only certain factors
in reaching an administrative decision, the agency is not fr. v. EPA, 541 F. 2d 1, 31 CD.C. Ci;. 1976).
"'- 1IA v. EPA, 14 ERC 1906, 1520 (D.C. Cir. 1980).
"-Per example, the Office of Technology Assessment distinguishes "Rij.k-
Based Laws" (also erroneously called "zero-risk laws"), "Balancing Laws," and
"Technology-Based Laws." See Technologies for Detenir^i'"g Cancer Risk fron
the Environment (CTA, June 1981); William Rodgers uses the terms "cost-
oblivious," "cost-effective," "cost-sensitive," and "cost-benefit" statutes ir
"Benefits, Costs and Risks: Oversight of Health and Environmental Decision-
Making," 4 Harv. Env. L. Rev. 191 (1980); Janes Leape classifies Laws into
"Balancing Statutes" and "Health-Only Statutes," in Quantitative Risk
Assessment," 4 Harv. Env. L. Rev. 86 (1980). The classification of laws by
these different commentators and others has not been consistent.
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-83-
Thus, whila certain statutory provisions may be "health-biased," it is essen-
tial to analyse the entire regulatory program to assess the "balanced" or
"biased" natura of the law.
la addition, most "health-only" provisions are associated with pure
designation decisions. For example:
• TSCA section 5(b)(4)(A) is purely a designation
provision which does not itself authorize regulation, as
is OTA section 311, RC?Ji section 3001 and CI3CLA section
102.
In many other instances, statutes combine a risk-based designation
provision with cost-sensitive regulatory authority. TSCA section Ma)
designation of substances for issuing test rules is based solely on risk
criteria but section 4(b) testing standards are to be based on cost and
feasibility considerations. See Exhibit 14. Only a limited number of
statutory provisions appear to authorize regulation without consideration of
economic factors. These are:
• Safe Drinking Water Act section 1421 (Underground
Injection Control)
• RCRA sections 3002-4 (Standards for Generators,
Transporters, Treatars, and Disposers of Hazardous Vast as)
• FIFRA section 25(c) (Special Packaging Standards for
Pesticides)
• CAA section 112 (National Emission Standards for
Hazardous Air Pollutants)
In the case of the NZSHAPs program, the EPA has incorporated economic
analysis into its standard-setting for airborne carcinogens. The role of
economic factors in standard-setting under RCXA may be resolved through
litigation. Many non-EPA laws similarly avoid mention of the role or ecssooic
factors. This applies to many of the DOT, FDA and USDA laws but net to the
QSHA Act, the Atomic Energy Act, or the Consumer Product Safety Act.
Another way of understanding the relative roles of risk, economic, and
technical factors is to consider the levels of protection authorized by the
different statutes. These are summarized in Exhibit 15. In several
instances, statutes direct the setting of "tolerances", for example,
consistent with protection of the public health; if a zero-tolerance or ban is
not authorized, some level of risk will result, as for tolerances established
for carcinogens. This should be contrasted with provisions allowing for a
margin of safety which have been called "essential to any health-related
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EXHI3IT !•*
OVERVIEW 0? STATUTORY RISK AND ECONOMIC CRITERIA
PROVISIONS INCLUDING
RISK-3ASZD PROVISIONS ECONOMIC "ACTORS
*TSCA §4 (a) - >- ' ' ............... . . i , ! , . ! *rsCA §4(b)
TSCA §5 (b) (4) (A) TSCA §6
*CWA §3C7(a) ...... . i . . . . , , . i . . . . ..... . . .. *CWA §307 (b)
CWA §311
*SDVA §14I2(b) (1) '•''•»'> ..... ' ' i ' • . - i i i i *SDWA §1412{b)(3)
SDWA §1421
RCRA §3001
RCRA §3002-4
7IJRA §25 (c) FIFRA §3, §6
CAA §108, §109 CAA §110
CAA §112(a), (b)
CAA §157
*CAA §202(a)(l) ............. ' " ..... ' " -••" *CAA §202(a)(2)
CAA §211(c)
*CAA §231 (a)—-** - ' ' ' ' ' ' ' " ' ' ' ' ' ' ' ' ' ' ' ' *CAA §231(b)
CZRCLA §102 -- ' ' ' ' ' .............. ...in Elsewhere in CZRCLA
OSHA §6(b)(5)
H)CA provisions except §409 FDCA §409
FKSA/PPPA CPSA
* "Matched pairs" combining a risk-based designation provision with cos:
sensitive standard-setting (or compliance) provision.
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-35-
EXHI3IT 13
LEVEL OF PROTECTION AFFORDED 3Y CHEMICAL CONTROL LAW'S
TSCA §6 (a)
CWA §307(a)
SDWA 11412
MPRSA
RCRA
FIFRA
CAA §109
CAA §112
CAA §211
OSHA
DOT/HMTA
DOT/USC3
"To protect adequately against (unreasonable risks]
using the least burdensome requirement"
"an ample margin of safety" (§307(a)(4)) through
applying 3est Available Technology (3AT) economically
achievable (§307(a)(2))
as close to the Maximum Contaminant Level (MCL) "to
the extant feasible ... (taking costs into
consideration)" §1412(a)(2)
no unreasonable degradation
"necessary to protect human health and the
environment" (§§ 3002-4)
no "unreasonble adverse effects"
"adequate margin of safety"
"ample margin of safety to protect the public health"
CPSA
"ample margin of safety"
"adequately assures, to the extant feasible, that no
employee will suffer material impairment of health or
functional capacity" §6(b)(5)
"reasonably necessary or appropriate to provide safe
or healthful employment ..." §3(8)
"necessary or appropriate"
"necessary to prevent/protect ..." FVSA 33 USC §122.5
"increased protection against hazards" throug-i
application of Best Available Technology unless undue
economic impacts would result "which are not
outweighed by the benefits" 3FCLA
"reasonably necessary to prevent or reduce an
unreasonable risk of injury"
-------
environmental standards if a reasonable degree of protection is to be provided
against hazards which research has not yet identified."*:j
Language authorizing a margin of safety in agency standards has been
interpreted as allowing greater discretion far both designation and standard-
setting. In the case of the Clean Water Act, where the "will cause" language
seern^ to tolerate less uncertainty than a "may" foraulation, the mandate-to
provide a. margin of safety was the basis for a ruling upholding ZPA's use ;f
information about more chlorinatec ?CBs as the basis for regulating less
chlorinated ?CBs (about which little was known). This decision upheld EPA's
aurhcrity to draw inferences from available data on related substances without
requiring proof of causation for each distinct chemical even where the
statutory criteria used the unconditional word "will."
S;JS. Rep. No. 91-1196, Clean Air Act Legislative History.
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IV. REGULATORY ANALYSIS
OVESVI2V
There are two different ways that chemical substances can be designated
and regulated. One approach is to identify and list specific chemical
substances. The other approach is to identify the harmful characteristics or
effects which would qualify a chemical for regulation, leaving it up to
private industry to determine which substances have such characteristics or
effects. While each approach has particular advantages and problems, the
reader should remember that regulatory programs frequently use both approaches
(e.g., RCRA, SOT, FIT3A).
As will be seen, analyzing the specific substances which have been
designated is much more difficult than analysing the hazard classifications
established by regulation. For a variety of reasons, it was not feasible to
conduct a meaningful, ia-depth analysis of all the regulations designating
chemical substances. In addition to the absolute numbers of substances
involved, other factors include:
• differences in statutory criteria for designation
• variations in the level of hazard presented by the
sane substance in different media
• inconsistent use of identifiers and naming conventions
• varying priorities among the different regulatory
programs
• varying levels of scientific uncertainty regarding
risk potential of chemicals
Therefore, the analysis of chemical substances designated by name for
regulation by January 1, 1931, takes the fora of a discussion of kay issues
and problems using specific examples as illustrations. The discussion is sot
exhaustive. In most cases, the examples used were derived from the creation
and review of a "matrix" which collects the various substances designated.
The development of the matrix is described in Volume 4 along with the coding
system used. However, specific findings are discussed hers as well.
In contrast, -the analysis of hazard classifications and associated tasting
requirements is more comprehensive. Again, only hazard classifications
proposed by January 1, 1981 are included, with the exception of the OSHA
labelling standard which was both proposed and withdrawn during January of
1981; it is included in the analysis for information only. Testing
requirements which are part of hazard classifications are analyzed; however,
many other specific testing standards do exist although they do not fall
within the, sca-oe of this contract.
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ANAIYSIS ?F DESIGNATED CHZMICAL3
All regulated chemicals are designated in one way or another. As parr of
this study, ICF developed a chemical designation matrix to list those sub-
stances designated by name in all the agency regulations reviewed. Together
with the analysis of hazard classes, the matrix can be used as a starting
point to identify possible gaps, conflicts, and inconsistencies. Here we
review the key findings derived from the development and ana.lysis of the
matrix.
There is a variety of reasons for the designation of chemical sufastanc.es
for regulation, all dependent upon the statute and agency involved. The
matrix demonstrates the outcome of agency actions as of January 1, 1981. See
Exhibit 16. The matrix also demonstrates significant designation problems;.
Different naming conventions, incomplete and overlapping chemical groups, and
different treatnent of compounds and mixtures all make it very difficult to
follow one substance through several regulations. These problems are
discussed in mere detail below .La the following order:
• Overview
• Naming Conventions and Synonyms;
• Designation of Chemical Groups;
• Designation of Compounds; ana
• Designation of Mixtures and Concentrations.
VHAT THE MATRIX SHOWS: AN OVERVISV
The primary factors that determine which substances are designated are
the regulatory authority embodied in statutory risk criteria and the available
scientific evidence. Thus, it is difficult to make analytical inferences from
the matrix. Just because a substance is listed does not mean it is unsafe in
all uses or exposures. The use of or the environment affected by a particular
substance may determine its classification. For example, a chemical in food
dyes may be classified as hazardous, whereas the sane chemical used in
pesticides say not be. Also the assumptions that agencies make concerning
risk assessment, are likely to vary. These assumptions concern such issues as
dose relationships, margins of safety, and models of data extrapolation, and
may affect which chemicals are designated as hazardous. Finally, the manner
in which ageacz.es view exposure levels to substances may vary. Some agencies
may consider the effects of chemicals as additive (e.g., FDA); in this ca.se,
exposure to several chemicals would be considered as one large hazardous
exposure. Other agencies consider the effects of chemicals individually, as
if humans were exposed to chemicals in a vacuum.
In addition to different risk criteria and available scientific
knowledge, there are other reasons why it is difficult to use the matrix to
assess gars and inconsistencies in designation. For example, in implementing
-------
-89-
T 16
SOURCES OF DESIGNATE) CHEMICAL SUBSTANCES
ID in Matrix Stature Regulations'"•'
FVPCA Federal Water Pollution Control Act
§307 Toxic Pollutant Effluent Standards 40 CTR 129
§311 Designation of Hazardous Substances and -0 CTR 117.3
Reportable Quantities 40 CTR 116.4
CAA - Clean Air Acr
§108 Criteria Pollutants 4Q CTR 50
§111 New Source Performance Standards 40 CTR 60
§112 Hazardous Air Pollutants 40 CTR 61
§202 Motor Vehicle Emissions id CTR 33
§211 Fuels and Fuel Additives 40 C7R 30
§221 Aircraft Emissions 40 CTR 37
SDVA Safe Drinking Water Act
§1412 Primary & Secondary Dr:_2Jcing --C GFR 141
Water Standards
RC3A Resource Conservation and Recovery Act 40 CFR 261,
Hazardous Wastes Appendix VIII
TSCA Toxic Substances Control Act
§4 Testing Requirements 43 TR 43534
§5 Premanufacrure Notification 45 ?R 238CS
§6 Limitations on Use 40 C7R 761
40 C7R 762
44 7R 60C61
FTDA/7TJHA Food * Drug Administration/Federal.
Insecticide, Fungicide 4 Rodenticide
Act (EPA)
Pesticides with. Established Tolerances 4Q CTR 130
FI7RA Federal Insecticide, Fungicide & 4Q CTR 162.30
Rodenticide Act (EPA) 40 C?R 152.11
MPRSA Marine Protection Research & Sanctuaries 40 CTR 22"
Act (Z?A)
C?SA Consumer Product Safety Act (CPSC) 16 CTR
-3
16 CFR
45 FR 2
302. 2
2C4
-------
-90-
EXHI3IT 16 (Continued)
SOURCES OF DESIGNATED CHEMICAL SUBSTANCES
Ma-srix Statute Regulariotis 1J
?P?A Poison Prevention Packaging Act (C?SC) 16 CFR 1700.14
FHSA Federal Hazardous Substances Act (CPSC) 16 CFR
15 00. 12 -17
CSHA Occupational Safety & Health Act (OSKA)
§6b 29 CFR 1910.1000
§6a 29 CFR 1900.1000
HjfTA Hazardous Materials Transport
Action Act (DOT) ' 49 CFR 172.101
7DA rood and Drag Administration2-1 - 21 CTR 510
ljThis exhibit: contains general references showing where the substances
are listed. However, the matrix contains all rules proposed or promulgated
by the agencies as of January 1, 1981, so there are many other Federal
Register notices used to update and revise the CTR references.
2J7he natrix lists for the FDA the 24 substances waich have been banned
under the Food, Drug and Cosmetic Act, not the thousands of substances for
which tolerances have been established by regulation.
-------
-91-
their lagal authorities, agency programs may vary both in priorities and in
total resources available for implementation.
Beyond this, provisions for variances, exceptions, and exclusions may
result in potential real-world inconsistencies that would not be at all
apparent from a review of the matrix. A good example of this is the reporting
requirement for hazardous polluting substances established under Section 311
of the Clean Water Act codified at 40 CTR 117. The exceptions for (1)
discharges from facilities with National Pollutant Discharge Elimination
System (NPDES) permits and (2) discharges from other publicly-owned zreatment
works (PCTWs) allow significant opportunities for gaps or inconsistencies in
reporting. A discharge of a hazardous substance excluded from Section 211
coverage may exceed the Part 117 reportable quantity for that substance, and
yet, not be controlled under other regulatory or statutory provisions. This
allows the possibility of discharges which exceed Pare'117 raportabie
quantities and "may be harmful." In addition, not all the hazardous polluting
substances designated under Section 311 have also been designated as toxic
effluents under Section 307.
Despite the difficulties in comparing the designation of hazardous
substances, the form of the matrix emphasizes several important aspects cf the
way agencies designate chemicals.
• Naming conventions and definitions are not always
standardized and may conflict.
• Some regulations often do a poor job of identifying
synonyms for listed substances.
• Much inconsistency exists in the use of generic terms
designating groups of substances.
•_ The regulations are either vague or in conflict wish
respect to the designation or inclusion of compounds,
isomers, etc.
• Treatment of mixtures is limited and ad hoc.
Examples appear throughout che matrix and demonstrate the variety of
policies that exist for designating substances. Some selected examples (e.g.
arsenic compunds, ?C3s) are included in the analysis.
Besides demonstrating how chemicals are designated, the matrix also
demonstrates which chemicals are designated most often. Certain sufaszancss
stand out b«cause they are designated under many regulations. These sub-
stances, because of their hazardous nature, prevalence, potential threat, or
even notoriety, are designated under -seven or eight statutes or provisions cf
statutes. Those appearing under eight columns include:
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-92-
• lead
• endrin
• benzene
* arsenic
* asbestos
Those appearing under seven columns consist of:
• acryionitrile
* aidrin
* cadm ium
* chiordane
DDT
11 heptachlor
* vinyl chloride
" mercury
Several of these are pesticides (endrin, aidrin, heptachlor, .and DDT), while
others (mercury, lead, cadmium, vinyl chloride., etc.) are used in a variety of
epplications.
It is important to emphasize that simply because a substance is not
listed does not mean that it is necessarily safe in all uses or not a public
health problem. For example, at the time the Interim Primary Drinking Water
Regulations were proposed, EPA had recently cancelled all use of DDT and
suspended the major uses of Aldrin/Dieldrin, exercising its authority under
7irRA.52J MCLs for these substances were not proposed, therefore, until
ongoing research could determine the extent to which these chemicals might
continue to persist in drinking water. Similarly, the proposed MCLs for
chiordane, heptachlor, and heptachlor epoxide were deleted from the Final
Interim Regulations because EPA was involved at the time in suspension and
cancellation hearings for these pesticides.53J Thus, because of the many
confounding factors affecting the presence cr absence of a chemical
designation, a comprehensive analysis of "gaps" would not be meaningful.
NAMING CCN".~NTTON'S AND SYNONTYMS
A basic problem in comparing any kind of chemical designations is the
number of nomenclature systems presently used by different industries,
5*JSee the preamble to the proposed interim drinking water regulations,
40 ~ 11991 (March 14, 1975), and the review of Safe Drinking Water
regulations in Volume. 2.
59578.
-------
-93-
goverranent , and researchers.**-1 The systam of nomenclature (or combination
of systems) used in designating chemicals depends on: (1) when the
regulations were promulgated, since naming conventions have evolved ever the
years, and (2) to what group of people the regulations are targeted . KM7A
regulations need to be understood by the transportation industry, which is
accustomed to one set of names and numbers, while FTF5A regulations ara used
by the chemical industry and by users, like farmers, both of which earolcy
different naming conventions. The most common naming systems, all of which
are seen in the matrix under different regulations, include the following:
System: This system, most recently developed,
names compounds on the basis of their molecular structure.
A set of rules is applied to give a unique name to aver?
compound , including structural and stericchemical isomers .
This system is the most specific and complete, because onca
a simple set of rules are understood, any compound can be
given ane specific name. This system can be recognized by
the use of numbers in parentheses (e.g. tetrachloroethane
(1, 1, 2, 2-)), and the use of certain suffixes and prefixes
(e.g. -one, -ol, eta-, prop-). What is gained by clarity,
in this system, however, is often lost in long, cumbersome
names that may be difficult to read, remember, or
understand. For this reason, this newest system has not
been taken up by many laymen and industries who still use
the systems described below.
Common Maming System: Chemists have often employed a
"common" name to refer to a widely used compound. Although
common names reveal the true chemical formula of a compound,
and are shorter than IUPAC names, they are more ambiguous,
and consequently were more difficult to natch u? with
chemical groups and synonyms when constructing the matrix.
Common names, nonetheless, are widely used and can be
recognized (at least the simpler ones) in the matrix by the
use of a series of groups. For example, heptanone (3-) in
the IUPAC system has the common name of ethyl butyl ketone,
where all three words refer to different chemical groups.
Common names have been in use in this country much longer
than the ItTPAC system. The regulations, therefore, tend to
use these names quite often, especially with widely used
chemicals .
**•' Besides nomenclature systems, these are also several numerical
systems (not included in the matrix) for naming chemicals. Examples include
the Cnited Nations System (U.N.), Chemical Abstract Service (CAS) numbers, and
the Standard Transportation Commodity Code (STCC) system.
-------
" C'r.asics.1 Abstract Service, w'a.ich also designates every
checical by s. CAS number, utilizes thair OWE system of
nomenclature. The system primarily employs IUPAC rules and
names except for a few deviations. To ensure that chemicals
are properly identified, CAS publishes several references,
including the Chemical Index Guide and the Registry
Handbook of Common Names that cross-reference CAS, IUPAC,
and common names. Most cf the CAS names would be included
in the matrix since they usually correspond to TUPAC names.
* Generic Names: A generic name makes it easy for a layman
to iaent;.fy a particular compound or product. These names
are especially appropriate when it is the layman who will be
dealing with the chemical, such as designating consumer
products for special labeling. An example of a generic name
would be rubbing alcohol. This name can be easily
understood by those who will be using it (consumers).
However, ethyl alcohol, the "common" name, and ethanol, the
TUPAC naiae, would not be. Generic names are also used for
some mixtures, and for products that have certain uses or
sources, (e.g., "mineral spirits," "c.oal tar dyes") instead
of distinguishable chemical formulations.
• Brand Names: Pesticides are often designated by brand
name (aldrin, mirex, parathion) because they (1) are a
mixture cf isotaers or active ingredients, (2) are often very
long, complicated names, and (3) are protected by trade
secrets. Some pesticides are identified by both the active
ingredient and the brand name (Ventox, ?umigrain =
acrylonitrile), others (Aldrin, Baam) by just the brand
name, and others by just the active ingredient (DDT, TDE,
etc.). Even with an extensive knowledge of chemistry, it is
difficult to match up different formulations and trade names
with the active ingredients that might be designated under
other statutes. Therefore, some substances may be listed
unknowingly twice in the matrix: once under the brand name,
and once under the chen^cal name.
The matrix is useful in this case because it indicates the names that are used
by each agency, for each chemical, and under each naming system.
No regulations use one naming system exclusively, although there are some
trends. FVTPCA §311, for instance, tends to include both the "UPAC and common
name, with one as a synonym. HMTA and RCRA, on the other hand, primarily use
common names, but not exclusively. The source of the substance often
determines the name that is used. Any widely used industrial chemical has
usually been referred to by a common name for years. A pesticide that has
been developed recently may have an IUPAC name or a shortened version of an
TUPAC name. ("or example, 2-4-D acid = 2, 4 dichiorophenoxyacetic acid). :in
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orfaer words, the actual name by which the substance is rafarrad to depends en
a variety of factors, all of which make it difficult to utilize one system
across the board.
The variety of naming conventions would not necessarily be a significant
problem if the regulations themselves provided suitable cross-rafarancas to
synonyms. They do-not. In fact, tracing the regulatory status of a
particular chemical is often quite difficult. FVPCA §307 regulations do not
generally identify synonyms while FVPCA §311 regulations do list ail synonyms
of each substance, whether there are two names or five for one chenicai
substance. HMTA regulations usually list only one name, axcapt in a few
instances where tao names are listed. SCHA regulations list some syncnyas,
but not all of the time. FTFRA regulations often do not adequately cross-
reference brand names to chemical names. This problem gets compounded by the
alternative ways that chemicals are designated in groups, discussed next.
DESIGNATION OF CHEMICAL GROUPS
The use of generic categories further complicates the analysis of
designation. Designation of a class of chemicals (e.g., chlorinated
benzenes) can subsume many individual substances. Although the Intaragancy
Testing Committee can include no sore than 50 entries on its recommended
priority testing list, for example, use of chemical classes means that the
actual number of chemicals recommended to EPA expands to over a thousand. Cn
the other hand, there may be good reasons for designating chemical classes as
opposed to individual substances. For example, establishing a drinking water
standard for total trihalomethanes rather than for specific compounds is
required by available testing and analytic constraints. The problems arise
where agencies define or interpret designated chemical groups in diffarsnt
ways.
Where chemical classes are used instead of specific substances,
opportunities for inconsistencies or conflicts can arise. MPRSA dumping
permits are issued by two separate organizations that each have discretion in
interpreting criteria for permit approval. To assure consistency, sors
specific designation, of limitations and allowances on ocean dumping of
identified chemicals (e.g., organohalogens) aay be advisable.
Another major problem arose in the attempt to cross-reference groups of
chemicals between regulations. In general, elements such as chlorine and
arsenic, that appear in many compounds and forms (chlorine, chlorides,
caloric, etc.) are not clearly designated in the regulations even though each
form of the element nay present entirely different hazards. A good example is
provided in Exhibit 17, which outlines the designation of arsenic compounds in
proposed or final federal regulations. Confusion arises from the designation
of groups and substances within that group. For example, HMTA designates
both inorganic arsenicals and a number of arsenic compounds such as arsenic
bromide, arsenic sulfide, and arsenic trioxide, as hazardous. All of the
arsenic compounds that are listed would normally be considered inorganic
-------
~96~
0? ARSENIC ASC ARSENIC COHPOOHOS
IS THE Ke3ClA~IOHS
Arsenic end oOBpounds
5311
Inorg«nxe arsenical*
Calciua arsenat*
Calcina ortho»r»«n«t*
Ars«(tic duioliid*
tod VMnic •ul£id«
«cid cnnydndc
Xrmenic trichloride
Ar*«nic chloride
Aixnou* chloride
Barter of »r»«nic
CJA
$112
\r»enic.
SCHA
xrsenxe
Ar»«nic end coapoimd*,
ArMnic p«nsoxid«
Arsenic «cid
Arsenic
Inorganic crsenieal*
ucenete
Inorganic ar»«nic4ij
ABBoniun arsenic*
Arsenic
Arsenic acid
Arsenic pentoxide
Arsenic erioxidt
Calcina arsenctc
Copper acecoarsenite
Sodium arsenate
Sodium arsenite
Sodiua pyroarsenate
OSHA
Arsenic (organic)
Inorganic arsenical*
Calciim arsenarc
56)5
Arsenic, Inorganic
HXTA
Arsenic
Inorganic arsenical*
Arsenic broordt
Arseoic caleride larseniousj
Arsenic disulfid*
Arsenic suicide
Arsenic iodide
Arsenic pencoxide
Arsenic sulfid* and « chlorite, «
Arsenic tricolorloe
Arsenic crioxide
Arsenic trisulfide
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-97-
arsenicals. If "inorganic arsenicals" is meant to include ail inorganic
arsenic compounds, why are some listed, and some not? If not, then what does
inorganic arsenicals include? See question marks in Exhibit 13, drawn from
the chemical designation matrix.
The point here is chat the regulations are not always developed or used
by personnel trained in general chemistry, much less-in specialized fialds.
Without specific knowledge of the general meaning of these taras, and the way
agencies use them, it is difficult Co identify particular chemicals in
designated groups.
Another problem arises when agencies give categories special definitions
that do aot clearly follow the category name. For example, under CSHA §6b,
''inorganic arsenic" includes "copper aceto-arsenate, and all inorganic
compounds containing arsenic except arsine, measured as arsenic" (29 CTR
1910.1018(b)). Copper aceto-arsenate, in a strict sense, is not an inorganic
chemical, because it contains organic carbon. Arsine, on che other hand,
would normally be considered an inorganic arsenic compound. When comparing
the QSHA designation with FVPCA §311, which also covers inorganic arsenic
compounds, it is clear the latter does not utilize the same definition as CSKA.
Besides the overlaps and conflicting names, cast methods nay determine
which compounds are included within a designated category. Because agancies
may not require the same tests, this could lead to different classifications.
In any event, deciphering the list of arsenic compounds requires aot only
in-depth knowledge of chemical structure in general, but, specifically, how
different agencies define and group different structures.
Where regulations are unclear, general chemical knowledge provided the
basis for categorizing and cross referencing chemical groups. It is important
to remember that there may be agency policies--unrecognized in Che aatrix--
that categorize chemicals differently, or deal with some substances within the
category in a different manner.
DESIGNATION OF COMPOUNDS
Exhibit 17 also points out another basic uncertainty in the cefinitica.
(or lack of a definition) of the word "compound". An agency designates a
chemical, such as arsenic, as hazardous, and then aay or nay aot list or
otherwise include its compounds, isomers, hydrates, or mixtures. On zhe one
hand, the regulations nay specify that the element or compound specifically
listed includes other forms. For instance, under FVPCA §311, the designation
of a hazardous substance includes "any isomers and hydrates, as well as
solutions and mixtures containing these substances" (40 C7S 116.i). Under
FPVCA §307 and SDWA, the designation of compounds simply includes organic and
inorganic compounds. In order to match up these chemicals with H*TA cr the
CAA designations, which only include inorganic arsenic compounds, every
arsenic compound must be evaluated and placed in one of these grcups.
-------
-96-
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-99-
With one exception discussed below, the interim primary drinking watar
regulations for inorganic chemicals (see 40 C7S 141, Sufapart 3) do not specify
whether a standard refers to a contaminant only in its elemental fora or as it
is found in certain or all compounds. Clearly, such, a distinction is
important, though it. is never addressed in the Preamble or body of the
regulations. The only guidance EPA gives at all on this issue is in the
prescribed test and measurement procedures. For each contaminant, EPA
specifies the procedure which must be used by state authorities to last for
its presence in drinking water supplies. According to an EPA official, these
procedures identify the contaminant in all forms, elemental and compound, in
which it may be present.11J Mercury, however, is defined in the
regulations as mercury and "mercurial compounds" specifically, for reasons
that are not made clear. Moreover, the interim regulations for radionuclides
and organic chemicals are extremely specific in defining the exact compounds
to which they refer. EPA appears not to have adopted a uniform designation
approach and format in this instance.
On the other hand, regulations nay refer to chemicals "not otherwise
specified," (n.o.s.) that differentiate between those that are listed
separately, and those included within a group. One problem that arcsa with
designation under SC2A is that it uses the "a.o.s." designation aven if thera
are no other compounds listed, which leads to a confusing search for other
compounds. HMTA is even less specific. The DOT hazardous materials tabla
lists an element, and then only some of its compounds, without an a.o.s.
specification at all. In the matrix, therefore, the designation of an alament
under HMTA did. not automatically trigger the inclusion of its isomers or
compounds.
DESIGNATION OF MIXTUSZa AND CONCENTRATIONS
Mixtures also make it more difficult to compare the designation of
particular substances under different statutes. Certain mixtures may pose
greater hazards than the constituents by themselves because of chemical
reactions between constituents. Cn the other hand, mixtures that contain only
trace quantities (i.e., low concentrations) of hazardous constituents, or that
neutralize the hazardous attributes of the consti-c-aents, nay not be hazardous
at all.
Because it is impossible to predict which hazardous substances will be
mixed together, most agencies tend to list the individual element or compound,
except where mixtures can be predicted (i.e., specific waste streams,
products, etc.). .A further problem reflects inconsistent definitions of zhe
designated mixtures. Finally, the designation of mixtures using generic aames
(e.g., shellac, rubber curing compounds) makes it impossible to identify all
regulated constituents.
"•'Personal communication witirE. Sellack, EPA, on October 2, 1330.
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w-naet TYP'JA §211, the d
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-101-
The designation of PCS's is an interesting case because ?C3's ara not
producad in pure fora except for research purposes. Rather, "hey axis, as
complex mixtures of PCS molecules which are typically described by the percsnt
chlorine content by weight. Most of the regulations give little guidance as
to which mixtures are covered, referring to "polychlorinatad biphsnyis"
without any more detailed description. s ij See Exhibit 19. Although the
definition seems to encompass all PC3 chemicals, there is some ambiguity' as to
whether monochlorinated biphenyls (MCB's) are included. 57J The few rules
which do provide definitions, however, ara quita consistent. Regulations
promulgated under FVPCA and TSCA both specify as PC3 ' s any compound or
"mixture of compounds composed of the biphenyl molecule which has been
• chlorinated to varying degrees."51-1
HAZARD CLASSIFICATION AND TESTING RSQUi
Many regulations designate not only specific chemicals, but also
characteristics of chemicals, as hazardous. The use of characteristics or
classifications has several advantages. First of all, under these rulas, it
is usually the responsibility of industry to test specific chemicals and
mixtures of chemicals for dangerous properties. Secondly, this "generic
approach" results in far acre comprehensive coverage than listing individual
substances, since all materials --not just those materials that the agancias
are aware of and have the resources to analyze — must be evaluated against the
hazard criteria. Finally, specifying general types of dangers also provides
structure to the regulations. Labeling and handling requirements ara
frequently organized according to hazard so that substances that pose similar
risks are treated in similar fashion. In this way, hazard classes say
determine how, as well as which chemicals ara regulated.
In establishing generic hazard classifications, agencies have set up (1)
exact, testable categories, (2) more general descriptive definitions and, (3)
in some instances, no definitions at all. Precise categories that ara
delineated by standard physical, chemical or biological tests, such as
flash-point ranges, appear to be the most, useful. In many cases, however,
"-'Although they fail to provide definitions, the regulations
promgulated under FDA and Section 311 of FVPCA do refer to the trade tame
Aroclor. See Exhibit 19.
57JMC3 mixtures can be produced by reducing the amount of chlorine
available for reaction with the biphenyl compound.
5IJThis specific definition is provided in the regulations promulgated
under Section 307 of FVPCA. Slight differences in the wording of the other
regulatory definitions are not significant.
-------
-1C2-
EXHIEIT 19
DEFINITIONS OF PCS ' s
Statuter*- Authrritv
TSCA
Definition
Fw*?CA, Section 307
FWPCA, Section 311
OSHA
FDA
TY.IA, EPIA, FZPIA
"... any chemical subs -ante that is limited to
the biphenyl molecule that has been
chlorinated to varying degrees or any
combination of substances which contains
such substance" (40 CFR 761. 2(s')).
"... a mixture of compounds composed of the
biphenyl molecule which has been
chlorinated to varying degrees" (40 CFK
129.4).
"for convenience of the user" only, CAS
Registry #1336363 and the synonyms Aroclor sad
Polych.lorinat.ed diphenyls are provided (40 CTR
116.4).
referred to as "chlorodiphenyl" (29 CFR
1910.1000).
"... a class of toxic industrial chemicals
manufactured and sold under a variety cf
trade names, including: Aroclor (United
States)" (21 CFR 109.15, 500.45, and
509.15)
none provided (see MPI Directive 917.1)"
none provided (see 45 FR 3456C).
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these are no reliable or comprehensive casts that cover all of the substances,
chat, for proper handling, should be grouped in one category. In chose cases,
agencies have utilized descriptive definitions chat require judgment and
interpretation; this also causes problems."-1
The different agencies, mandates, and methods have resulted in s. myriad
of testing requirements, classifications, cast levels, and permit condic-ions
chat regulated industry must satisfy. Some attempts have been made co
coordinate regulations, for instance between EPA under RC2A and DOT under
HKTA. However, inconsistencies exist both among and within different
agencies' programs. Cne important reason for this is the fact chat'each
regulation controls a different type of exposura--a characteristic w'oich :.s
hazardous in one medium (e.g., consumer products) may not be deemed hazardous
in another for which public exposure is smaller (e.g., solid waste).
Of course, existence of a logical justification does not alleviate indus-
try's problem in trying to comply with conflicting hazardous substance
classifications and tasting requirements. Industry must determine which
substances and which instances require casting. If the hazardous substance is
dealt wich by classification, inconsistent definitions of hazard classes and
cescing requirements can force firas co reevaluata cast data, or co perform
expensive new cests altogether. In addition, confliccing definicions
eliminate the simplicity which, after ail, is one of the main reasons for che
categories in the first place.
The analysis presented here shows Che kinds of class if icaticn used and
what tests must be satisfied. Included are the hazard categories (and
associated tasting requirements), if any, that have been established by seven
different agencies under nineteen separate statutes, as shown in Exhibit 1.
In general, there are different approaches to selecting hazard classes,
defining them with reference to specific cests, and specifying the cast
results that must be satisfied.
In order to better understand both the causes and affects of Che
inconsistencies, it is essential to analyze each type of hazard individually.
The analysis covers the following generic hazard class ificacions:
• Toxic Substances
• Fire Hazards
• Corrosive Hazards
• Reactive Hazards
• Radioactive Hazards
• Otaer Hazard Classifications.
isJSee, for example, DOT's Advance Notice of Proposed Rulemaking,
Definition of Flammable Solid, 46 T8. 25492 (May 7, 1981).
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-1Q4-
TCXIC S'JB STANCES
Overview. The term "toxic substance" encompasses, materials which
produce a vide variety of adverse effects, including neurological damage,
blood disorders, birth defects, and cancer.etj This diversity makes it ve:ry
difficult tc construct a comprehensive screening procedure--ssperially in
light of the long period of tine required for some of the effects to become
evident.
Agencies must make decisions about the regulation of toxic subtances,
basing those decisions on 1) criteria that are mandated in the statute, and 2)
whatever data, tests, or descriptions are available or possible to obtain.
Because of the diversity of toxic effects, levels of information on these
effects, and types of exposure to toxic substances, the toxicity of a
substance is often dealt with case-by-case through listing. However, there
are some quantifiable tests and data that narrow the judgmental area within
which the agency must make its decision.
EPA, for the most part, has used the listing mechanism to designate toxic
substances. For instance, under Section 112 of the CAA, EPA has designated
certain "hazardous air pollutants" (NESHAPS) primarily based on their acute or
chronic human toxicity. In designating certain chemicals, EPA has utilized
human studies and animal test data. The end result of these considerations,
however, is not an exact, testable category of "hazardous air pollutant", or
"toxic substance", but a list (over time) of specific chemicals that fit the
descriptive mandate in the statute. The determination of toxicity by EPA
under RCRA, TSCA, FIFRA, CAA, CWA, SDWA, MPR3A, and CERCLA follow this listing
procedure. The partial exceptions to this are RCRA, FURA and Section 311 of
CVA, all cf which are discussed in more detail below.
The rules promulgated under RCRA relieve industry of the testing burden
almost entirely, relying instead on the listing mechanism for designating
toxic washes. The only analysis required is the Extraction Procedure, which
is designed "to identify wastes likely to leach hazardous concentrations of
particular toxic constituents into the grounawater under conditions of im-
proper management."*l- The actual specification ef which constitutents are
toxic is still nade by EPA.
'°JIn this section "toxic substances" refer to human (or animals used
to assess human) toxic effects. Tests on aquatic animals and wildlife, and
other environmental toxic affects, are discussed under "Environmental
Hazards'' Deiow.
*'*-45 FR 22110 (May 19, 1980).
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Carrain SPA regulations under FIFHA and CWA Section 311 (Assignation of
Hazardous Substances) utilize toxicological data for screening purposes,
rather than for classifying certain toxicological ranges as "highly toxic,"
"toxic", etc. Under FIFRA, acute toxicity casts are used to catagoriza
pesticides for the purposes of labeling, classification, special packaging,
and triggering the RPAR process. Ail of the values (Oral LD5Q, Deraal 1250,
etc.) are shown in Exhibits 6-11 through 6-15 in the FIFRA Regulatory Raviaw
(see Volume 2). The labeling regulations, however, seem to fcra the basis
for the other FIFRA regulations and ara also the raost consistent with other
SPA and aon-EPA programs. In the generic classifications discussed belcw,
"FIFRA" refers to the labeling categories (I-IV) outlined in -0 CFH 152.10.
Regulations promulgated under Section 311 of the CVA to designate hazard-
ous substances and their reportable quantities for discharge include tcxicc-
logical selection criteria (see Exhibit 2-16, Volume 2). If a candidate
substance meets any one of these criteria, including toxicity to aquatic
flora, mammals (humans), or aquatic aniaals, then the substance is further
examined for discharge potential. Although the aquatic toxicity levels ars
sot used to define a generic category per se, the levels ara shewn for
comparison purposes.
Like EPA, other agencies deal with human toxicity case-by-case. C?SC,
USDA, and FDA all employ the listing mechanism, even though they nay require
toxieitv test data to be submitted. For example, for the approval of
external color additives, FDA recommends the following test data: "acute oral
toxicity, primary irritation, sensitization, subacute dermal toxicity on
intact and abraded skin, and carcinogenieity by skin application." (21 CF3
70.42). These tests, however, are not described further.
Some regulations, however, do include common toxicity cagagorias and do
describe toxicity tests, namely FIFRA, RCRA, HMTA, FHSA, and OSHA. However,
these regulations take a more segmented approach to the designation of toxic
substances, using the listing mechanism only to identify chemicals which
present hazards that cannot be easily tested. For this reason, each type of
hazard arust be considered separately. The following types of hazards will be
dealt with below:
• acute hazards
• chronic hazards
• Testing Reouirsments for Acute hazards: Acute toxicity can be
determined fairly easily, since the effects are unmistakeabla and, by
definition, appeai rapidly. The ease of measurement has encouraged adopticn
of testing requirements under RCRA, FIFRA, HM7A, FHSA, and proposed by OSHA.
The criteria for acute hazards ara very similar, as shown in Exhibit 20.
The ojost important difference readily apparent in the rules is the absence of
a separata inhalation criterion for gases and vapors under SCRA, HUTA and
FI7RA. It is unclear whether these materials ara covered under the mhalaticr
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EXEI3IT 20
ACUTE TOXIC ITY
Oral Toxicity
LD50 '•-
Inhalation Toxicity
(mist, dust, and fumes)
LC50 *•"
Inhalation Tsxicity
(vapors and gases)
LC50 -
Deraal Toxiciry
RCRA FIFRA §311 HMTA .FHSA DSHA
X XXX XX
XX XXX
:jLethal dose at which 50« of the test animals expire, expressed in
terss of mg/kg of body weight.
2JLethal concentration in air, at which 50% of the test animals expire,
expressed in mg/1.
'-'Lethal concentration at which 50% of the test animals expire, ex-
pressed in ppm.
"-'Lethal dose., applied to intact or abraded skin, at which 5C% of the
test animals expire, expressed in terms of mg/kg of body weight.
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criterion for mists, dusts, and fumes and assuming they ara, to what axtent
the 2 tng/1 and 200 ppm limits are related.
Exhibit 21 clearly shows that differing classifications have been
developed to describe the same levels of toxicity. Conversely, ciifarent
levels of toxicity may be described by the same classification. There ara
also subtle differences between the group definitions which obscure the '
different acute toxicity test results shown in Exhibit 23. A number of
inconsistencies arise, for example, in the specification of animal test
populations. The HMTA and FHSA regulations, and QSHA's prcposed labeling rule
grant ao leeway -- oral and inhalation tests must be administered, to rats
weighing between 200 and 300 grams, dermal tests to rabbits weighing between
2.3 and 3.0 kilograms. The number of animals must be at least 10 and, in the
case of FHSA, "sufficient to give a statistically significant result."'2'
Under FURA, on the other hand, certain test populations are not required in
the regulations. Instead, they refer to the Registration Guidelines for
further explanation. S3J CWA, Section 311 Toxicological Selection Criteria
(40 CFR 116.10) do not provide any recommendations for test populations, nor
do the RC3A regulations at 40 CFR 261.11(a). The acute toxicity tasting
protocols may also prescribe different lengths of time that the tast aniaals
must be watched for adverse effects after the exposure is complete. For
example, FHSA and OSHA require an observation period of 14 days, while DOT
requires a perioc of only 43 hours. Other regulations, such as RCRA, do not
spell out observation period requirements.
The regulations, differ not only in the nature of the animal test popula-
tions, but also in the conditions to which those populations must be exposed.
For example, the rules promulgated under HKTA and FHSA, unlike the ones pro-
posed under GSHA, do not requira -'-halation toxicities to be tasted to the
full 2 mg/1 (or 200 ppm) limit as long as "such concentration is [un]likely to
be encountered by man when the substance is used in any reasonably forseeabla
manner."'*- In addition, the OSHA regulations require exposure periods to
be extended from one hour to four "where there is difficulty aaistair.ing a
steady concentration.""-1
«2J16 C7R
"•"March 1980 Draft Proposed Registration Guidelines.
'*J49 CFR 173.343 (a)(2) and U CSC 1261(h)(1)(b).
ISJ46 FR 4412 (January 16, 1981) OSHA Proposed Rules on Hazards
Identification, withdrawn for consideration by new administration Fabruarr 12,
1981, 46 FR 12020.
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-108-
Tox:.c Toxic
Poisor. A or B
ITM—i
Highly
TQX..C Toxic
III IV
i Toxiciry[Category •_,
Hazardous
CVA
Acut ely
Hazardous
R:RA
5 50 500 5000
B. Inhaiericn Toxiciry (mists, dusts, arid fumes)
Highly Toxic Toxic
50,000 LD:;o (nig/kg)
Pcison A or
r.igr.iy ioxic .oxic
I . II III IV
?I~?Ji , Toxicitv ,Care?orv ,
Kassrdous
20 200 L:.0(a£/l)
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-109-
EXHI3IT 21 (Continued)
TOXICITY TESTS
C. Inhalation Toxicity (vapors and gases)
Highly
Toxic
Toxic
OSHA
FHSA
CWA
Highly
Toxic
Hazardous
Toxic
20
200
2000
20,000
200,300
D. Dermal Toxicity
OSHA
KMTA
FHSA
FU5A
CVA
RCRA
Highly
Toxic Toxic
Poison A or 3
Highly
Toxic
Hazardous
Acutely
Hazardous
Toxic
II III
Toxicity. Category
20
200 1000 2000
20,000
IV
200,000
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are ocre difficult to
quantify thar. acute toxicity, as explained below. The major classification
under chronic toxicity is csrcinogencity, how»ver, other categories include
nut«g«nicity end teratogenicity.
Cc.rci3oger.iciry, in contrast to acute toxicity, is very difficult to
determine because of a. number of factors:
('.) the long-tern nature of cancer development;
(2) the small proportion of populations exposed to
carcinogens which actually contract the disease; and
(3) the multiplicity of possible cancer causes which can
interfere with the selection of control groups and the
interpretation of experimental results. .
The resulting problems in establishing testing protocols have led to the
adoption cf listing as the primary mechanism for designating chemical
carcinoger.s.
In most case:;, the listed carcinogens are not distinguished from other
designated substances. For example, asbestos is classified by DOT together
with inflatable life rafts as an ORiJ-C to indicate that it is a "material . . .
unsuitable for shipment unless properly identified and" prepared for
"ransportation.""'- In other cases, carcinogens are listed separately,
31 though there may not be an established policy for listing the substance.
."near Clean Water Act Section 307, EPA identifies carcinogenicity as a
criterion for listing the substance as a "toxic pollutant". However, thers is
•30 published set of tests or hazard levels that define carcinogenicity under
Clean Water Act Section 307.
Carcinogen policy is still changing due to new data, newly suspect
carcinogens, and litigation. The following List suc/aarizes the status of
regulations under each statute as they relata to hazard classification, as of
January 1, 1981. These are described in more detail in the regulatory reviews
for each regulation.
Carcinogens, mutagens, and teratogens are
listed, by chemical, at 4.0 CFS 261.33(f) as "toxic
wastes"; Appendix VIII of 40 C7R 261 includes
CAS-identified carcinogens which could be the basis for
listing a hazardous waste.
"J49 C7H 173.500(b)(3). Inflatable life rafts and asbestos are
identified at 49 C7R 137.906 and 49 CFR 173.1090, respectively.
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-111-
TSCA: Carcinogens are identiiiad and listad by
chemical under Section 4, and are dealt with
case-by-case under Sections 3 and 6. There ara so
established test protocols as of January 1, 1981.
FTTRA: Carcinogenicity is a factor in
classification and registration. Registration
Guidelines, when finalized, will describe tasting
methods.
CAA: Carcinogenic air pollutants have been listad
separately, but policies proposed under Section
112—National Emission Standards for Hazardous Air
Pollutants--would establish general criteria for
listing carcinogens as hazardous air pollutants.*T-
Four hazardous air pollutants have been designated
because of their carcinogenic effects.
CVA: Similar to the CAA, carcinogens are generally
not listed separately or categorized as such. However,
EPA has recently proposed, through EPA's Carcinogenic
Assessment Group, a general method for designating
carcinogens under Section 311.tlj
SDVA: There is no separata listing or policy for
suspect or confirmed carcinogens.
MPRSA: The regulations under this Act prohibit the
dumping of carcinogens, outagens, or teratogens except
as trace contaminants. They do- not supply a procedure
for their identification.
HMTA; DOT tends to follow EPA's designations in
this respect. Carcinogens are not listad separately
but ara included in the CEM-E class of hazardous
materials.
*7J "National Emission Standards for Hazardous Air Pollutants: Policy and
Procedures for Identifying, Assessing, and Regulating Airborne Substances
Posing a Risk of Cancer," 44 FH 53642 (October 10, 1979).
"-'See the Proposed Amendment to Expand Selection Criteria +5 T3.
(July 9, 1930).
-------
* £2§±: Regulations 'under FKSA, C?SA, and ??PA do not
aescribe or define carcinogenicity.
* OgHA: In OSHA's proposed labeling regulations
(later withdrawn), a "carcinogen" is a substance which
meets the definition of "Potential Occupational
Carcinogen" (20 CFR 1990.103 and 1990.143-144) or which
is identified in a previous OSHA regulation as &
carcinogen (20 C7E 1910)."-'
' ~-2A '• Through the Delaney clause of the FDCA, all
food and ingested color additives that are known to
"cause cancer in man or animals" are prohibited in any
concentration. These are dealt with case-by-case,
using the "iudgement of appropriately qualified
scientists ".TIIJ
As seen in the above summary, only three regulatory strategies have
emerged that attempt to classify or set up a screening process for
carcinogens. These are: 1) CAA, Section 112, proposed policies for
regulating airborne substances posing a risk of cancer; 2) OTA, Section 311,
proposed designation of hazardous substances for their carcinogenic effects on
man; and 3) the proposed OSKA Cancer Policy.
All three proposed cancer policies entail a two-step process:
1) Ar. assessment of the probability of carcinogenicity
based on human epideniological data, animal test data,
and chemical structure information; and
2) An evaluation of the probability and extent of exposure
to the potential carcinogen.
The first step is, the most important to this analysis', the latter step
involves analyzing different medias, substances and industries, and cart-not be
compared between regulatory programs.
EPA, through the use of the erstwhile Interagency Regulatory Liason Group
(IRLG) had proposed some degree of consistency between the CAA and CVA
policy. Tor CVA Section 311, EPA's Carcinogenic Assessment Group (CAG),
"JCSKA Proposed Rules on Hazards Identification, 46 FR 4412 (January
16, 1961). Withdrawn February 12, 1981, 46 FR 12020.
"-21 CTR TC.50(a;
-------
-113-
formerly evaluated the data and relegated the chemical to one of thrae
categories : 71J
• Best evidence of Hunan Carcinogenicity- -Positive
epidemio logical studies and confirmatory animal tests.
• Substantial Evidence of Human Carcinogenieity--^n-'-nal
bioassay tests demonstrating the induction of malignant
tumors or the induction of benign tumors that are
generally recognized as aarly stages of malignancies, in
one or snore species .
• Suggestive Evidence of Human Carcinogenicity--An-:^al
bioassay tests demonstrating the induction of
non- life-shortening benign tumors and also positive
results in indirect tests of tumorigenic activity (e.g.,
mutagencity) , in vitro cell transformation, and
initiation-promotion skin tests in mice.
Compounds in the first two categories were to be further evaluated for
discharge potential and regulation.
CAA Section 112 proposed policies prescribed a very similar sethcdolcgy,
using the same I3LG terms ("best", "substantial", etc.), except the categories
are arranged dif ferently: 71J
• High Probability of Hnma-n Carcinogenicity- -Substances
for which "best" or ' substantial" evidence exists frcm
epideaiiological and/or at least one mammalian study.
• Moderate Probability of Human Careinogenicity--
Substances for which "suggestive" evidence exists from
epidemio logical, animal, or short term studies.
• Low Probability of Himq-n Carcinogenicity-Substances
for which only "ancillary evidence exists, such as frcm
structural correlations, or for which epidemiological or
animal results are judged to indicate low probability.
"Best", "substantial", and "suggestive" all had the same meanings as 'jnder CVA
(listed above). The term "ancillary" was also an IRLG term, aot used in the
CWA determination. The meaning is self-evident from the proposed GAA
regulation.
71J45 F3 46097 (June 9, 1980).
7SJ44 FS 5S6o9 (October 10, 1979).
-------
Unlike EPA, wnich sets tap a gradient c,f three categories, CSHA's cancer
policy relied OE two: Category I Potential Carcinogens, and Category II
Potential Carcinogens. A Potential Carcinogen had first to meet the
definition cf a "potential occupational carcinogen" defined as:
"any substance, or combination or mixture of substances,
which causes an increased incidence of benign and/or
malignant neoplasms, or a substantial decrease in the
latency period between exposure and onset cf neoplasms in
humans or in one or more experimental mammalian species as
the result of any oral, respiratory or dermal exposure, or
any other exposure which results in the induction of tumors
at the site other than the site of administration. This
definition also includes any substance which is metabolised
into one or more potential occupational carcinogens by
nanaaals." (29 CFR 1990.103)
Beth categories had to meet the above definition. The two (I and II) a::e
differentiated by the certainty of the evidence involved. A Category I
Potential Carcinogen must have been demonstrated in humans with other test
d?ra as confirmation 7:j Those substances that only show suggestive
?r\dence, ar are net in concordance with ct-bei test data, were tc be relegated
•',, Category II. 7k-J
OSEA's Category I seems to correspond to a sum of ZPA's "best" and
"-•.ibstantial" evidence categories. Because the OSEA definition was much mo::e
";% icific, however, it is difficult ~c compare "he two methods of
.. ossification.
ategory I Potential Carcinogen, evidence of carcinogenicity
must be demonstrated in: (i) humans, or (ii) in a single mammalian species in
a long-tern bioassay where the results are in concordance with some other
scientifically evaluated evidence of a potential carcinogenic hazard or (iii)
in a single mammalian species in an adequately conducted long-term biossay, in
appropriate circumstances." (29 CFR 1990.112(a)). Concordance is
demonstrated by any of the following: "positive results from independent
testing in the same or other species, positive results in short-term tests, or
Induction of tumors at injection or implantation sites." (29 CFR 1990.112(a)).
7fcJA Category II Potential Carcinogens are simply substances which: (1)
''meet the criteria set forth in 1990.112(a) [for a Category I Potential
Carcinogen), but the evidence is found to be only 'suggestive'" or (2) "meet
the criteria set forth in 1990.112(a) in a single mammalian species without
evidence cf ccrcordance" (29 CFR 1990,112(b)).
-------
-115-
Mutagenicity and teratogenicity, are not established categories. CSHA,
however, had proposed special labeling for "reproductive toxins" (teratogen)
defined as: "Causes fetal wastage or undergrowth, malformation, growth
retardation, or functional disorders in the products of mammalian conception,
or prematurity or diminished fertility in mammals. "7SJ
FIS£
The term "fire hazard" is a relative one. Virtually anything vill burr.
•when subjected to the proper catalyst. However, the danger is significant
only when the conditions required to initiate combustion correspond to those
normally encountered by the material. Since ignitafaility depends en the phy-
sical state of chemicals, liquid, solid, and gaseous fire hazards srust be
analyzed separately."-1 In general, regulations that prescribe special
handling, conditions of use, and particularly labeling for hazardous
substances will classify fire hazards. Out of the nineteen statutes reviewed,
only regulations under RCSA, FITRA, HKTA, Coast Guard (USC3) , and CSHA provide
f lammability definitions and testing methods .
• Liquid Fire Hazards: Essentially, the sole determinant of liquid
ignition is temperature. Every liquid exhibits a "flash point" above which it
emits vapors sufficient to form an ignitable mixture with the air near its
surface. Without exception, all liquid fire hazard categories are based on
such flash points. Nevertheless, there are many important differences between
the regulations.
The flash point ranges which define the classes under the various pro-
grams differ according to the .temperatures normally incident to handling the
respective materials (see Exhibit 22). For example, the 14.0°? "ignitability"
criterion established under RCBA was chosen specifically to relate to " the
potential sources of ignition existing at a landfill site, such as hot truck
exhaust pipes and heat from- neutralization reactions. "77-! In defense of
this unique flash point cutoff, EPA stated that "while [the Agency] believes
that maintaining consistency between its definitions of hazard and those of
the Department of Transportation is a desirable goal, it does not believe that
such consistency should be achieved at the expense of human health and envi-
ronmental protection."71-1
7»J46 FR 4443 (January 16, 1981).
7''Pyrophoric-materials and cxidizers are discussed in the section on
"Other Hazards."
T7J42 F3 22232 (May 2, 1977).
7tJ45 FR 33108 Oiay 19, 1980).
-------
.ASH ?GINT RANGES FOR LIQUID FIEZ HAZARD CATEGORIES
RCRA
Ignitable
OSHA
Extremely
Flammable
Flammable
Combustible
FI7RA
Extremely
Flammable .
"lammabl'
[Other Fire Hazard]
KHTA
Flammable
Combustible
Flammable
Combustible
("open-cup test)
FKSA
(open-cup test)
Extremely
Flammable
Flammable
Combustible
0 20 40 60 SO 100 120 1*0 160 180 200
FLASH POINT(°F)
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-117-
The regulations differ not only in the flash point ranges used to define
the hazard categories, but also in the test methods authorized far determini
the ignition temperatures. Most of the classifications require the use of
"closed-cup" tests (?ens Icy-Martens, Sexaflash, or Tagliabue).rsj Even
though there are scma differences in the way that the particular casts are
described and their suitability for various samples are explained, the
closed-cup procedures are standard enough that the variations ara not believed
to pose a problem. Ona possible exception is in the tasting of mixtures.
EKTA requires that mixtures with flashpoints above 20° be retestad after being
evaporated to'90% of their original volume. OSHA requires a similar retest,
but only for mixtures with flashpoints above 100a. Finally, SCRA does not
require retesting for mixtures.with any flashpoints.
Unlike the other testing requirements, FESA and USCG mandate vise of an
ooen cup tast,taj which typically gives higher flash point rasults.38
With respect to FHSA, such tests mere nearly approximately conditions when the
liquid is in the open. It is unclear, though, why they ara more appropriate
for consumer exposure than for, say, occupational exposure. The Coast Guard,
which has r=tained some of the old DOT regulations,12-' defines flammable
liquids first by flash point with an open-cup test (see Exhibit 2^), and then
into 5 "grades" (A-E) by Reid vapor pressure and flash point (io C7R 30.10-22).
7SJThe RCSA rules also authorize use of any "equivalent test methods
approved by the Administrator." However, no open-cup tests have been—or are
expected to be--granted approval since they yield higher flashpoints than the
closed-cup tests, and are therefore not "equivalent."
IJJ16 CF5 L5.43. . Both the open-cup test and the flash point ranges were
originally mandated in the FHSA itself. However, the Act was amended in 1978
in order to allow the Commission to change these specifications. Apparently,
the main reason for the amendment was to facilitate" coordination of hazard
categories between agencies. The statute states that "in establishing
definitions and test methods related to flammability and combustibility, the
Commission shall consider the existing definitions and test methods of other
Federal agencies involved in the regulation of flammable and combustible sub-
stances in storage, transportation, and use, and to she extant possible, shall
establish compatible definitions and test methods" (13 USC 1251(1) as amended
in Pub. L. 95-631).
*1JGordon P. -McSinncn, Fire Protection Handbook (Boston: National Fire
Protection Association, 1976).
I2JDOT (under HMTA), also used to allow open-cup results. However, the
Department decided that the open-cup tests were insufficiently reproducible to
be used as a basis for determining hazard. See Docket EM-102.
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-118-
' Sc_Lid Fire Hazards: Tne flasmability of solids, unlike that of
liquids, depends an more than just one factor. I:: addition to ambient tem-
perature, ctner sources of solid ignition include internal energy, absorbed
moisture., and "hot spots" forced through friction or retained heat. Unfor-
tunately, it is currently impossible to measure all of these characteristics
-,u the laboratory. As a result, no tests for thermal instability are totally
adequate. Kovevei, classifications have been set up for flammable solids
•oncer RCRA, HXTA, ?KSA and OSHA (FI7RA does not include such s. classification).
In the absence of satisfactory test methods, all but the FHSA (and OSHA,
to some extent),13- regulations rely on a aescriptive definition for
flammable solids (see Exhibit 23). For instance, in the Preamble to the RC5.A
rule, the EPA pointed out that there were "no test methods capable of
accurately identifying the small class of ignitable solids" to which the
regulation was directed. Although EPA, along with DOT and other agencies, :.s
•/orkirg on developing an accurate test, "the absence of a test should not
cause too much cf a problem since g-e-neratcrs of thermally unstable solids . .
, are likely to b« aware that their wastes exhibit this property."1-1
However, industry representatives claim that the descriptive rules give them
itt'sufficier.r guidance. One obse-ver has conmented that "such a definition Ls
•'•,ill enough of obscure and nebulous phrases ^:> prevent reasonable product
- ' assif ica".isn indefinitely."85-1
In addition to prescribing different ignitability characteristics, the
==ralaticns under each Act also specify different conditions under which some
'* the sane characteristics oust be manifest. To be considered ignitable, for
;-ample, a solid must exhibit flaraoable properties at standard temperature and
-•-assure under RCKA, or at any conditions "normally incident to transpcrta-
..-..on" under HMTA. Any material that meets the hazard criteria at a tempera-
*--c,re, such as 90°?, which is aoove standard temperature but within the range
:f crnditions ''normally incident to transportation," is therefore classed as a
.."laiamable under HMTA only.
The regulations differ not only in the ignition characteristics., but also
in the combustion [combustion characteristics describe the way a flizmmable
solid bums after ignition] characteristics they designate a:; hazardous. At
"-'The CSEA labeling proposal mentions the same test as the FHSA regula-
tions. However, even materials which fail the test might be classified as
flammable under CSEA as long as they satisfy the remainder of the definition.
$kjPreamble to the RCRA regulations, 45 FR 33108 (May 19, 1980).
is-?o.charc D. Hilton, "Consolidation of Hazardous Materials Regulations
and Miscellaneous Proposals," Transportation Journal, Volume 16, Number 3
(Spring 1?T7) .
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-119-
E2HI3I7 22
DEFINITIONS OF SOLID PISE HAZARDS
RC2A "ignitable waste"
A solid "capable, under standard temperature and pressure, of caus-
ing fire through friction, absorption of moisture, or spontaneous chemi-
cal changes and, when ignitad, burns so vigorously and persistently that
it creates a hazard" (40 CTS. 261.21 (a) (2)).
HXTA "flaomable solid"
"Any solid material, other than one classed as an explosive, which,
under conditions normally incident to transportation is liable -a causa
fires through friction, retained heat from manufacturing or processing, or
which can be ignitad readily and when ignited bums so vigorously and
persistently as to create a serious transportation hazard. Included in
this class are spontaneously combustible and water-reactive aatarials" (49
CFH 173.150).
FHSA "extremely flammable solid"
"A solid substance that ignites and bums at an ambient temperature
of 80°? or less when subjectad to friction, percussion, or alactrical
spark" (16 CIS L300.3(c)(6)(iii)).
FHSA "flammable solid"
"A solid substance that, when tasted [according to a cartain proce-
dure] , ignites and bums with a self-sustained flame at a rate greater
than one-tenth of an inch per second along its major axis" (16 CFR
lJ00.3(c)(6)(iv)).
OSKA "flammable solid"
"A solid other than an explosive, that can cause fire through fric-
tion, absorption of moisture, spontaneous chemical change, or retained1
heat from manufacturing or processing, or that can be readily ignitad and,
when it is ignited, continues to bum vigorously and persistently after
removal of the source of ignition. A material is considered a flammable
solid if, when it is tested [according to the FHSA aethcd], i- ignires and
bums with a self-sustained flame at a rate greater than one- tenth of an
inch per second along its major axis" QSHA Proposed Hulas on Hazards
Identification 46 FR 4412 (Jan. 16, 1931).
-------
firs- reading, RCRA and ittTTA appear to be consistent in this respec::, smce
they sots. cssta-iTi the phrase "...bums so vigorously and persistently as re
create £ ... hazard." However, -his criterion is a necess&ry condition for
classification as a fire hazard under RCRA, but simply one of severs.!
sufficient condition under EMTA."J The OSHA craft regulations are similar
to tie HMTA rules in this respect. Any solid which, when ignited, "continues
to cum vigorously and persistently after removal of the source of ignition"
is considered flammable. * '•'
• Gaseous "ire Hazards: In contrast to both solids and liquids,
gases are rarely stored or transported in the sane physical state as they are
used. Instead, the materials are kept in a more economical condensed form and
are released through either expansion (as in the case of compressed gases) or
propulsion (as in aerosols). RCRA, FIFRA, HliTA, FHSA and CSHA have ail
established gaseous fire hazard classifications.
The susceptibility of gases to fire depends on three factors:
1) inherent flamrnability of the vapor;
2) conditions of containment; and
3) conditions of dispersal.
Standard procedures or definitions have been developed to test each one of
these factors. However, the procedures and terminology for gaseous fire
hazards have not seen uniformly accepted. Compressed gas, for instance,is
defined by the OSHA proposed labeling regulations, under HKTA, and under
RCRA. "The Coast Guard, as well, regulates the carriage of "liquified
g, ,~es."*'- The oaly significant coordination has been between the RCRA and
1!JActually, EPA originally tried to coordinate' the RCRA regulations by
proposing the "hazardous combustion" criterion as a sufficient condition.
However, the definition was changed in response to industry comments that i:.
''could be construed to include such non-hazardous materials as bark, wood
chips, waste paper, sawdust, corrugated boxes, etc." (45 FR 33108 (May 19,
ISSC'j). It is doubtful that these comments (and therefore the
inconsistencies) were truly justifiec--scrap paper, sawdust, and woodshav-
ings are regulated as Other Regulated Materials-C, rather than as flammable
solids, under HMTA (49 CFR 173.1070,5).
46 TR 4112 (January 16, 1981).
"JUSCG regulates vessels carrying "bulk liquified gases", including
some that are flammable. In this case, the Coast Guard defines a "liquefied
gas" as £. cargo having a vapor pressure of 25 psi at 100°F. Notice that this
category is physically somewhere between the two sufficient conditions under
OSI-IA.
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-121-
HMTA definitions of "flammable (or ignitable) compressed gas", and betwean
OSHA and ?HSA definitions of "flammable gases and aerosols". Conformity was
facilitated in the first case by EPA's realization that "the major hazard to
the environment arising from flammable gases would be during transport."*3'
On the other hand, the types of containers and methods of storage confuse
the categories: "ignitahle compressed gases", "flammable aerosols",J:- and
"flammable contents of self-pressurized containers" all contain compressed
gases.
CORROSIVE HAZARDS
The term "corrosion" is frequently used to encompass two distinct phenom-
ena:
1) destruction of living tissue; and
2) degradation of metal containers and transport vehicles.
Because of the differences between these two processes, it is important -hat
they be considered separately. Although corrosive substances are regulated
under almost all of the statutes in Exhibit 1, only regulations 'incer RC3A,
HMTA, ?HSA, and GSHA have established specific, testable categories.
• Tissue Corrosion; Materials which corrode living tissue present a
direct threat to humans and require special cars in handling. They can be
readily identified though a rabbit skin test. Indeed, this technique has been
adopted under most regulatory authorities as the sole determinant of skin cor-
rosivity (Exhibit 24). Even chemicals which do not meet the rabbit skin
corrosion criterion may be considered corrosive if, under RCRA, KlfTA, and
OSHA, they are otherwise known to cause "visible destruction of or
irreversible alterations in living tissue by chemical action at the site of
contact."'1-1 FI7SA labeling regulations, however, do not specify tests, but
do assign those pesticides that are: 1) "corrosive".to the skin, or 2)
"corrosive; corneal opacity not reversible within 7 days'1 to the eye, to
Toxicity Category I (most hazardous). *2J
"-'43 FH 58951 (December 13, 1973).
J8JSome chloroflurocarbon propellants are also regulated by FDA, C?SC
and EPA because of their effect on the ozone layer and public health.
liJS«e RC2A Draft Proposal for 40 CFR 780.2 (July 29, 1980); HMTA regu-
lations at 49 CFX 173.240; and FHSA regulations at 16 CTS. 1.500.3(c) (3).
''-40 CTS 162.10(h)91)
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EXSIBIT 24
CORROSIVITY TZSTS
Tissue Corrosion Me~al Corrosion
Sreel Tssr Aluminum Test
RCPJ. X X
SCA
FKSA
DSHA
*/The period of exposure required by C?SC under FKSA is 2* hours, com-
pared zo just 4 hours required by regulations under HMTA and OSHA.
**/Cherr.ic.ais which corrode aluminum are classified as ORM-B under HJTTA.
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-123-
The RCSA regulations, however, employ a much simpler pH criterion for
corrosivity. The rabbit test was rejected in this case because o: a belief
that "requiring the regulated community to conduct skin corrosion tests, which
necessitate the maintenance of special facilities and skilled personnel, would
prove unnecessarily burdensome and would yield little in the way of extra re-
sults. The pH test was chosen as a substitute because, even in light of a
CPSC survey which casts doubt on the ability of ?H to predict tissue damage,"
EPA decided that "there is sufficient correlation between [the two] to justify
the use of pH in a regulatory context, especially in view of the fact that
[the Agency] is using pH as a multi-purpose measure of aany elements cf con-
cern." Besides harm to human tissue, the other concerns signaled by pH in-
clude the ability of wastes
1) to promote the migration of toxic components from other
wastes;
2) to react dangerously with other wastes; and
3) to harm aquatic life.J3J
• Metal corrosion: Unlike tissue corrosion, metal corrcs-on
presents only an indirect threat to people -- either through liberation of
hazardous chemicals in the same or nearby containers, or through damage to
transport vehicles. Perhaps because of this indirect course of action, only
two regulatory programs currently designate metal corrosion as a hazardous
property. Because it deals with consumer items ?HSA expressly forbids
inclusion of metal corrosion, stating that "the term 'corrosion' . . . shall
not refer to action on inanimate surfaces."'*J
The two regulations which do cover metal corrosion require identical stael
corrosion tests (see Exhibit 27). The RCSA test was taken directly from DOT
Hazardous Materials rules after EPA determined that" the Agency's "concern
about container damage is identical to that of DOT's in this case.""J DOT
also requires an aluminum corrosion test to identify Other Regulated Materials
- 3 (ORM-3's), defined as those materials "capable of causing significant
damage to a transport vehicle or vessel from leakage during transport."'SJ
The ORU-B category was created primarily for the air transport of corrosive
materials, where the corrosion of aluaiaum could be a major safety hazard.
SIJ45 FR 33109 (May 19, 1980).
**J15 USC 1251 (i).
'*J43 F5 539S1 (December 13, 1978).
"J49 C7R 173.500(b)(2).
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A reactive material is defined ruder 3SKA as "a chemical substance or
mixture char, is able to undergo a violent, self accelerating, exothermic
chemical reaction with common materials or by itself and includes a substance
cr mixture tiiat falls within [one of three categories which are discussed
below: organic, peroxides, pressure-generating materials, and water-reactive
materials].'7J EPA found, in formulating the RCRA Regulations, that the
methods c:irrent:y available for testing this class of properties suffer from a
nucber "f shortcomings:**-1
"First, these tests are too restrictive in scope and
confine themselves to measuring how one specific aspect of
reactivity correlates with a specific initiating condition
or stress. No test is sufficiently general to even begin
to measure the variety of different stresses and reactions
found within the reactive classification.
Second, because the reactivity of a . . . sample is &
function not just of its intensive properties such as
density and composition but also of its extensive
properties such as mass and surface area, the reactivity of
the sample as measured by the tests will not necessarily
reflect the reactivity of the whole ....
Third, most of the available tests are not of the
"pass-fail" type and recuire subjective interpretation of
results."
l>.e unavailability of suitable test methods has forced the regulatory agencies
-.j rely or. descriptive definitions, as in the case of solid fire hazards.
Because of the differences between the various types of reactivity discussed
below, for the most part each type is specifically mentioned in the
regulation:;.
Under RCRA, however, substances which would be classified separately under
other statutes as explosive, water-reactive, etc,, are all grouped together in
the "reactive" definition. Pare 261.23 of the RCRA rules give eight
"properties" that parallel the subcategories established under OSHA, ffifTA, and
FKSA. The subcategories established under reactive hazards are discussed
below. The reactive hazard definitions are shown in Exhibit 28.
>7jCSKA Proposed Rules on Hazards Identification 46 FR 4412 (January 16,
1981).
"-'Preamble to RCRA Regulations 45 FR 33110 (May 19, 198C).
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• Explosive Hazards: The descriptions used to designate explosive
hazards vary significantly from regulation to regulation. Under OSHA and
SCSA, explosives are defined according to their properties, as shown in
Exhibit 23. Under HMTA, however, explosives are designated according to
use. Substances which produce an "instantaneous release of gas and heat,"
but which have a "primary or common purpose [other than] to function by
explosion" are not considered explosiv-e materials.**J The RCRA regulations,
finally, adopt an intermediate approach. They designate as "reactive" wastes
which either aeet the DOT criteria for "forbidden", "class A", or "class 3"
explosives, or .
conditions:I4aj
1) exposure to standard temperarare and pressure;
2) heating, while under confinement;
3) nixing with water; or
4) initiation from "strong" sources.
• Water-reactive Hazards: Water reactivity is designated as a
separate hazard category only under OSKA. The group is defined zo include any
"chemical substance or mixture that reacts with water to release heat or a gas
which is hazardous."1'1-1
However, the same water-reactive hazards are covered, at least to seme
extent, by other programs. The RC2A regulations, for example, classify as
"reactive" any waste which "reacts violently with water, or foras potentially
explosive mixtures with water". lai-i Materials which, when mixed with water,
"generate toxic gases, vapors, ot fumes" are also covered, but only as long as
they do so "in a quantity sufficient to present a danger to human health cr
the environment."1"1-1 In this way, substances which are designated
water-reactive under OSHA simply because they emit trace amounts of hazardous
gases are excluded under RC3A.
An even greater proportion of water-reactive chemicals are excluded under
HMTA. The regulations classify water-reactive solids- as flammable
"J49 CF3 173.50.
Iaaj40 CTS 261.23(a). See 45 73. 33122 (Say 19, 1980).
1>1JOSHA Proposed Jules on Hazards Identification 46 FS 4412 (January
16, 1981).
0 CFR 261.23(a)(2).
183J40 C7R 261.23(a)(4).
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EXHI3IT 25
DEFINITIONS 0? RZACTIV-^HAZARDS
RCRA "Reactivity"
A representative sample of the waste has any of the following
properties:
(1) It is normally unstable arid readily undergoes
violent change without detonating.
(2) It reacts violently with water.
(3) It forms potentially explosive mixtures with water.
(4) When mixed with water, it generates toxic gases,
vapors or fumes is a quantity sufficient to present
a danger to humar health or the environment.
(j) It is a cyanide or sulfide bearing waste which,
when exposed to pK conditions between 2 and 12.5,
can generate toxic gasas, vapors or fumes in a
quantity sufficient to present a danger to human
health or the environment.
(6) It is capable of detonation or axplcsive reaction
if it is subjected to a strong initiating source or
if heated under conf iriement.
(7) It is readily capable of detonation or explosive
decomposition or reaction at standard temperature
and pressure.
(8) It is a forbidden explosive as defined in 49 CFR
172.51, or a Class A explosive as defined in 49 CTR
173.53 or a Class B explosive as defined in 49 CTR
173.88."
K.tl'A "Explosive"
"Any chemical compound, mixture> or device, the primary
or coicmon purpose of which is to function by explosion, i.e.,
with subtantially instananeous release of gas end heat" (49
CFR 172.50).
• "Forbidden explosives" - spontaneously explosive
• "Class A explosives" - "detonating or otherwise of maxinrum hazard"
• "Class B explosives" - explosives which "function by rapid
combustion rzrtner than detonation"
(e.g-i flash powder and pyrotechnic signal::)
• "Class Z explosives" - "manufactured articles which contain class
A, or class B, explosives, or both, as
components but in restricted quantities"
(e.g., small arms amnnm.iticn and certain
fireworks)
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-127-
E2HI3IT 25 (continued)
DEFINITIONS OF REACTIVE HAZARDS
OSHA "Reactive material"
"A substance or mixture that is able to undergo a violent,
self-accelerating exothermic chemical reaction with common aatanals or by
itself and includes a substance or aixrure that falls within any of the
following categories:
(i) 'Organic Peroxide' . . .
(ii) 'Pressure-generating material' . . .
(iii) 'Water-reactive material' ..." (46 FR ~L2,
January 16, 1931)
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-125-
materic.ls' °k- , anc "water-reactive pesticides" not covered elsewhere as
OSH-C's.iss- However, water-reactive liquids other than pesticides are
apparently net considered hazardous. In fact, even the liquid pesticides and
solids may not be included, since the term "water-reactive" is never explained
under EMTA other than to be loosely associated with fire hazards. FKSA
regu.1 d~icns, fzj-s,L:y, fail to mention water-reactive hazards at all.
* Pressure Generating Hazards: Substances which "generate pressure
through. dec:Dffiposi-ion, heat, or other means" were first regulated by
C?SC.'ot- Under FHSA, any material falls into this category
"(A) If it explodes when subjected to an electrical spark,
percussion, or the flame of a burniing paraffin candle
fcr 5 seconds or less.
(s) If it expels the closure of its container, or bursts
its container, when held at or below 130°F for 2 days
or less.
(C) If it erupts from its opened container at a temperature
of 13C°? or less after having been held in the closed
container at 13C°F for 2 days.
CD) If :t comprises the contents of a self-pressurized
container."107J
Presumably as a result of inadequacies in the test procedures, other
regulations have adopted descriptive definitions for pressure-generating
hazards, "or example, under CSHA, the hazard class is defined to include any
s-instance or mixture that "must be protected from spontaneous polymerization
b> the addition of an inhibitor, or by refrigeration or other thermal control;
cr mey decompose to release gas in its container."1'>J
RCrLA regulations-do not establish separate categories for pressure-
generating materials. However they do cover these substances. RCRA
classifies as "reactive" any waste which is "normally unstable and readily
111 "-'49 CTH 173.150.
:es-49 CFR 173.1040.
10'-1.5 DSC 1261 (f)(l)(A)(vi).
:'*-16 CT5 1500.3(c)(7)(i)(A-C).
:"-**6 T3 4447 (January 16, 1981).
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-129-
undergo«s violent change without detonating. "ias-i Included in this
definition are chemicals that exhibit a "tendency to autcpclyaeri;:e.!>i :I-
• Pyroohoric materials: Under OSHA, a "pyrophoric material" is
defined as ' a. chemical substance or mixture that ignites spontaneously in dry
or moist air at or below 130°7 (34.4'C).IM llj The same definition is
employed in the HMTA regulations, but only as applied to pyrophoric
liquids.;iaj Solids which are "spontaneously combustible" are classified
as DOT flammables.115-1
The same types of materials may also be covered under RC2A. Any substance
that "is normally unstable and readily undergoes violent change without
detonating" is included as "reactive" in the regulations.l1"J The Notice of
Proposed Rulemaking (NFR) aade it clear that "reactivity includes the tendency
to ... create a vigorous reaction with air."115-1 In addition solids
"capable, under standard tempature and pressure, of causing fire through . . -
spontaneous chemical charges" are classified as "ignitable."l;Sj
• Oxidizers: An cxidizer is defined under RdA,lir- and SKTA as
"a substance . . . that yields oxygan readily to stimulate the combusticn of
organic matter. "llt-i The proposed OSHA definition is only slightly
different, aeaning "a substance or mixrara that initiates or pramotas
combustion in other materials, thereby causing fire either of itself or
through the release of oxygen or other gases."11'-1
l"J40 CT5. 261.23(a)(l).
n»J43 j2 sa922 (December 13, 1973).
niJ46 FR 4447 (January 16, 1981).
i:2J49 CTR 173.115(c).
113J49 C7R 173.150.
llkJ40 CFR 261.23(a)(l).
115J43 FR 53952 (December 13, 1978).
11SJ40 CIR 26l.21(a)(2).
117J40 CTR 261.21(a)(4); Oxidizers are classified as "ignitable"
materials under SC2A, using the DOT definition.
lilJ49 CTR 173.151.
11'-l 46 ?R 4447 (January 16, 1981).
-------
Organic peroxides: Besides cyanide and sulfide compo'tinds, the
anic percxi.ce category is the only one which is based on the structure,
rather than on the properties, cf chemicals. The group is defined under HKTA
and OSEA to include any ''organic compound that contains the bivalent -0-0-
structrre and whic,i sney be considered a structural derivative of hydrogen
peroxide, :_a which one or both of the hydrogen atoms has been replaced by an
organic iddical.";:"- FKSA and RCRA regulations do not specifically mention
organic peroxides; however, they do include these substances if they exhibit
'j~.ber reactive characteristics such as explosiviry.
* Cyanide__and Sulfide Compounds: Cyanide and sulfide compounds are
specifically targeted for regulation only under RCRA. The rules designate a:s
"reactive" any "cyanide or sulfide bearing waste which, when exposed to pH
conditions between 2 and 12.5, can generate toxic gases, vapors or fumes in a
quantity sufficient tc present a danger to human health or the environ-
ROiir, ''i2:j The particular pH conditions were chosen because they "are
lvt--gy. As well, other government bodies have duties that require dealing
'•'!.::. radiation. This abundance of agencies involved in radiation protection
r= ••, evolved from the increasing use of radioactivity and the increasing
,-•, '.;es of exposure. Possible sources of radiation exposure include:
• occupationally-related radiation
• water contamination
• radioactive emissions into the air
• consumer exposure through electronic and other
products
• naturally occurring radioactivity through mining and
other activities.
l2t-'49 CTS. 172.151a; OSKA Proposed Rules on Hazard Identification 46 7R
4A7 (January 16, 1981).
:''-iO CFR 261.23(a)(5).
1:1-AS 7R 33110 (May 19, 1980),
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Because of the diversity of sources and types of radiation, there is 20
one definition for "radiation" or radioactive substance. Instead,
radioactivity is defined in terms of the type of suostance or activity that is
regulated under each particular statute. The next paragraphs discuss hew each
agency defines radioactive hazards .
Under the A£A, KRC regulations define "radiation" as "any or all of the
following: alpha rays, beta rays, gamma rays, X-rays, neutrons, high-speed
electronics, high-speed protons, and other atomic particles; but not sound or
radio waves, or visible, infrared, or ultraviolet light". ils-! However, the
AEA gives the authority to regulate only "the processing and utilization of
source, byproduct , and special nuclear material".12"-1 These are defined
as:
• Source material : (1) uranium or thorium, or any
combination thereof, in any physical or chemical form
or (2) ores which contain by weight one-twentieth of
one percent (O.Q5») or more of: (i) uranium, (ii)
thorium or (iii) any combination thereof. Source
material does not include special nuclear material (10
CFR 40.3).
» Byproduct material: any radioactive material
(except special nuclear material) yielded in or made
radioactive by exposure to the radiation incident to
the process of producing or utilising special nuclear
material (10 CJR 30 .4(d)) . 11SJ
Special nuclear material: (1) plutsniua, uranium
233 , uranium enriched in the isotype 233 or in the
isotope 235, and any ..other material which the
Commission . . . determines to be special nuclear
material, but do«s not include source material; or (2)
any material artificially enriched by any of the
foregoing but does not include source material (10 CT
Section 70.40!)).
ISJJ10 GTS 20.3.
12kJ42 U.S.C. 2012 (emphasis added).
i25J3y product material is also defined in 10 CFR 40.4(a), for use in
Part 40, which deals with mining and processing of ores, as "the tailings or
wastes produced by the extraction or concentration of uranium or thorium from
any ore processed, primarily for its source material content, including
discrete surface wastes resulting from uranium solution attraction processes.
Underground ore bodies depleted by such solution extraction operations do cot
constitute "bv-tsroduct" material within this definition."
-------
Note tb it only the first definition, of "radiation", really defines a class of
radioactive materials -- the other three (source, byproduct, and special
nuclear material) sr.erely define the kinds of radioactive materials covered
under AZA.
The KRC definitions form the basis for regulations promulgated by other
agsncies. EPA utilizes the same definition of "radiation" and "radioactive
material" in the regulations promulgated by and transferred to EPA under AEA.
Also, the CAA amendments of 1977 define "radioactive pollutant" (Section
122(aV; as "source material, special nuclear material, and byproduct material"
(42 L'.S.C. 74-22), and uses the same definitions as NRC for the three materials.
Radioactive substances are also regulated by EPA under SDWA and JtFRSA,
however neither provide an explicit definition of "radioactivity" or
radioactive substances." Drinking Water Regulations prescribe maximum
contaminant levels for several specific isotopes or types of radiation
(radium, alpha, beta particles, and protons), and also set a maximum dose
equivalent for others.12*-1 This is a listing procedure only, and does not
classify materials as radioactive: MPRSA, in the Act itself, prohibits the
dumping cf "High-level radioactive waste", which is defined in terms of its
source rather than a particular radioactivity level.127J All other
radioactive wastes are not defined as "low-level", but are also under special
restrictions (40 C'i"R 227.11).
Radioactive substances may soon be regulated under RCRA. EPA has already
proposed "to list the following radioactive materials as hazardous wastes:
waste rock and overburden from uranium mining; overburden and slimes from
phosphate surface mining; waste gypsum from phosphoric acid production; and
slag and fluid bed prills from elemental phosphorus production." Development
of final rules, however, was postponed pending Congressional action on H.R.
3994, (passed as S. 1156 in October, 1981), a reauthorization bill which
i-emporarily suspended EPA's authority to control energy-related radioaictive
wastes except as necessary "to prevent radiation exposure which presents an
unreasonable risk to human health from the use in construction or land
reclamation (with or without revegetation) of solid waste from the extraction,
1ItJ40 CTR 141. The maximum dose equivalents for all radionuclides are
not specified, but 40 CTR 141 refers the reader to those specified in "Maximum
Permissible Body Burdens and Concentration of Sadionuclides in Air or Water
for Occupational Exposure" NBS Handbook 69, U.S. Department of Commerce, 1962.
127-40 CTR 227.30. High-level radioactive wastes means the aqueous
waste resulting from the operation of the first cycle solvent extraction
system, or equivalent, and the concentrated wastes from subsequent extraction
cycles, or equivalent, in a facility for reprocessing irradiated reactor fue]
or irradiated fuel from nuclear power reactors.
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-133-
benaficiaticn or processing of phosphate rock or the extraction of uranium
ore."121-
OSHA, like EPA, uses the NSC definition of "radiation". However, GSHA
differs in the definition of "radioactive material". According to OSKA, (29
CFR 191Q.96(a)(2)) "radioactive material means any material which emits, by
spontaneous nuclear disintegration, corpuscular or electromagnetic
emanations". Because OSHA's authority covers more types of radiation than
NRC, which is limited to source, special nuclear and byproduct material, CSHA
has set up two. .categories. , "Ionizing radiation", (which includes the
definition above); and "son-ionising radiation," which includes sonic,
ultraviolet, microwave, and other electromagnetic waves that are tot amittad
by means of spontaneous nuclear disintegration.
Rules promulgated under both HKTA and FHSA provide the simplest definition
-- they designate as "radioactive" substances which emit ion-.7.-Tig
radiation.12SJ FHSA regulations supplement the definition given in the
Act: "Radioactive substance" means a substance which, because of nuclaar
instability, emits electromagnetic and/or particulate radiation capable of
producing ions in its passage through matter" (16 CFR 1500.3(c)(3)). The DCT
regulations, unlike any other radioactive regulations, exclude materials in
which "the estimated specific activity is act greater than .CG2 micracuries
per gram of material.llQJ
FDA, unlike DCT and C?SC, has a complicated system of identification for
radioactivity. The reason for this is che diversity of sources FDA
regulates: electronic products, microwave devices, medical uses of
radioactivity, and others.151-1 Part 1000.3 of 21 CFS provides definitions
for the following terms: "Electronic product radiation," "electromagnetic
radiation", "particulate radiation", and "infrasonic, sonic (or audible) and
ultrasonic waves." The FDA definitions tend to include all types of
radiation, including ionizing and nonionizing radioactivity. FDA
differentiates between electromagnetie radiation and particulate radiation,
while NSC and OSHA divide radiation into ionizing and r.on-ionizing forms.
The NSC definition, used by EPA and OSHA, covers all particuiate radiation, as
defined by FDA, and some other types of electromagnetic radiation (e.g.
X-rays, gamma rays) included under FDA.
121J45 FS 33086 (May 19, 1980).
i25-"49 C7S 173.389(e); 15 USC 1261(a). See 16 CFH 1500.3(c)(3).
1S*J49 CFS 173.389(e). This exclusion is based on the statuatory
language of the HNTA, §108(b), 49USC §1807(b).
;31J21 CTR 1000.
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Gne other problem with radiation protection is the units used to express
radioactivity. Tie basic unit of measurement is how much radiation is
ecitted, expressed in terms of the curie. The dose equivalent maasiirement is
extrapolated from the curie, and is expressed in rads or (usually)
rems."*ij The dose equivalent is based on "absorbed dose and appropriate
factors tc account for differences in biological effectiveness due to the
quality of radiations and its spatial distribution in the body." Consequently
the maximum dose equivalent may be set at different levels for different p£.rts
of the body, especially since some organs are more susceptible to damage or
health effects .
The HJlTTA regulations express the relative radioactivity of a substance
through curies only. Most agencies, including EPA, NRC, OSHA, and 7DA use a
combination of the two measurements for regulation. For instance, under SDWA,
EPA sets a maximum contaminant level for radioactivity that would produce 11
dose equivalent of 4 millirems/yr. to the whole body or any organ. Howeve::,
far certain radionuclides , EPA also sets maximum concentrations, rather than
dose equivalents, which are expressed in curies/liter.
In sunmary, :he regulations governing the classification of radioactive
substances are diverse and overlapping. The definitions tend to outline the
type of substances regulated for radiation protection under each statute.
NRC, although it has limited authority, has set the primary standards for
radioactive hazard classification. However, some types of radiation,
•--.f.pecially naturally occurring and accelerator-produced radioactivity and
erher low -level radioactivity are not covered in the NRC classification. The
.: ' ieral Regulatory Council, set up in 1960 to deal with interagency
jurisdiction over radiation, may be, in the future, providing more
e classifications for radiation protection. 133J
! CLASSIFICATIONS
* Irritants : Under FKSA, an irritant is defined as "a chemical
substance or mixture, not a corrosive, which on immediate, prolonged, or
repeated contact with normal living tissue induces a local inflammatory
I3:j40 CFR 192.02 defines the "curie" as: "that quantity of radioactive
material producing 37 billion nuclear transformations per second. (One
millicurie (mCi)—0.001 Ci.)" and "dose equivalent" as: the product of
absorbed dose and appropriate factors to account for differences in biological
effectiveness due. to the quality of radiation and its spatial distribution in
the body. The unit of dose equivalent is the ram (one millxrem (mrem)=0.001
res.)" Taese definitions are standard.
i23-'Bureau of National Affairs Environment Reporter, August 8, 1980, p.
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-135-
responsa. "l5*-i The regulations do nor rely exclusively on this descriptive
definition, however. Instead, they also require industry to perform rabbit
tests on all substances not shown by human experience to irritate 3k..m or
eyes.13ij The proposed OSHA definition is almost identical to the one under
FHSA, except that it is more specific: an irritant induces an "immediate or
delayed onset of an acute, subacute, or chronic local inflammatory response in
the skin, eyes, or mucous membranes by chemical action". This definition also
prescribes the rabbit tests described in the CPSC regulations.
A special classification for irritants has also been established under
HMTA, but it differs frsa the: OSHA and FHSA categories in a number-of ways:
(1) Only the HMTA rules specify thar "irritating materials"
must "give off . . . fumes."13'-1 In this way,
substances with low vapor pressures that cause
,irritation through direct contact with living tissue
are effectively excluded.
(2) The fumes generated by DOT irritants must not simply be
irritating, but "intensely irritating (emphasis
added)."137-1 This phrase has been interpreted to
mean, that the material must be irritating "to the
extent that [a person] cannot take the action necessary
to cope with the situation in the event of leakage of
the material."13iJ '
(3) A material may qualify as an HMTA irritant even if it
only exhibits hazardous properties "upon contact with
fire"131-1 (as in the case of edible tallow).
Some of these differences are corrected for by DOT through designation of a
second category for irritating materials. The "ORM-A" classification covers
any "material which has an anesthetic, irritating, noxious, tcxic, or other
13*J 15 USC 1261 (J).
13IJ The rabbit tests, including patch tests on abraded and ia-act skin,
and eyes, are described at 16 CFR 1300.41.
I3tj 49 CTR 173.381(a).
13?J Ibid.
131J 3ierlein, Redbook on Transportation of Hazardous Materials.
13SJ 49 CTR 173.381(a).
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£>:inil?.r-property and which can cause extreme annoyance or discomfort to
passengers and crew in the even of leakage during transportation."i*c-
Fiaaliy, FIFRA labeling, packaging, and classificaticsn criteria utilize
skin and eye effects. They do not define "irritant" per se, but ere
descriptive categories that lead to special labeling, packaging, or use.
There are no animal or other tests prescribed in the regulations . 141J'
• Sensitizers: The FESA defines a "strong" sensitizer" as
"substance which will cause on normal living tissue through an allergic or
photocyramic process a hypersensitivity which becomes evident on reapplication
of the same substance".1*2-1 The CPSC regulations further clarify this
definition by setting up rwo basic types of sensitizers:
"A 'strong allergic sensitizer' is a substance that
produces an allergic sensitization 'in a substantial
number of persons who come into contact with it. An
allergic sensitization develops by means of an
'antibody mechanism' ... An allergic reaction
ordinarily does not develop on first contact because of
the necessity of prior exposure to the substance in
question. The sensitized tissue exhibits a greatly
increased capacity to react to subsequent exposures of
the offending agent."
"A 'photodynamic sensitizer' is a substance that causes an
alteration in the skin or mucous membranes in general
or to the skin or mucous membranes at the site of
contact so that when these areas are subsequently
exposed to ordinary sunlight (or equivalent radiant
energy) an inflammatory reaction will develop."143-1
Both types are also regulated under OSHA. The proposed OSHA definition is
essentially the same as FHSA, except again it 'is more specific. A
"sensitizer" causes "humans of either sex, normal or medically disabled" to
develop a hypersensitive allergic reaction, or a photodynamic reaction.
They also elaborate on the hypersensitive reaction by including "the
anaphylactic, immediate, delayed, or fixed "ype, and may be of acute,
;*s-49 CF5 173.500(b)(l).
1*1-'40 CFR 162.10 (See FIFRA Regulatory Review, Volume 2).
J*S-FHSA 15 USC 1261(k).
ls:!-'16 CFR :.50C.3(c)(5).
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-137-
subacute, or chronic duration."14"-1 The coverage is far from uniform, since
the responsibility for identifying individual sensitlzers rasts with industry
under OSHA and with CPSC under FHSA. Sensitlzers may also be cavarad under
other statutes. Unfortunately, it is unclear to what extant a sansitlzar
qualifies either as. "a material which has an anesthetic, irritating, noxious,
toxic, or other similar property and which can cause extreme anncyanca or
discomfort to passangers and crew in the event of leakage during
transportation" (the definition of "QRM-A" under HMIA).1**
• Coaorassed Gases: Gases, which present a hazard because of their
compressed state of storage, rather than because of any intrinsic property
such as flannnability. or toxicity, are regulated only under I-QfTA and GSHA O9
CFR 173.300(a)). However, they may be included under other statutes, but in
different classes. "Compressed gases" may be flammable gases, pressure
generating, reactive, or pose other hazards. The regulations amp lay thrae
basic criteria to identify hazardous compressed gases:
1) absolute pressure in the container greater than -»Q ssi
at 70aF;
2) absolute pressure in the container greater than 1-0 psi
at 130aF; and
3) vapor pressure of any flammable liquid in the container
greater than 40 psia at 100°7.
The only inconsistency is the absence of the final criterion for CSHA.
The "compressed gas" classification overlaps considerably with other
categories including pressure-generating substances and flammable gases. Cne
particular inconsistency is the placement of "self-pressurized containers".
Under CPSC, they are regulated as a substance which "generates pressure
through decomposition, heat or other means". FTFSA regulations supply special
labeling for flammable or explosive pesticides in "pressurized containers" but
do not supply a definition of such.
• Etiologic Agents: Etiologic agents are currently regulated by
EPA, DOT, USDA, and FDA. The category is defined by DOT to include any
"viable microorganism, or its toxin, which causes or may cause human disease,
and is limited to those agents listed in 42 CTR 72.25(c) of the regulations of
the Department of Health [and Human Services]."1%SJ
l**J46 FS 4448 (January 16, 1981) (Proposed Xule).
l*SJ49 CF3J 173.50000(1).
l*tJ49 CF5 173.386(a)(l).
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-138-
Besides the Public Health Service regularions mentioned is the DOT
definition of eticiogical agents above, infectious agents are also regulated
by EDA and USDA through their inspection of food sold ir. or affected by
interstate commerce. None of these regulations, however, provide for a
classification of etiological agents.
I?A may regulate infectious agents through the CVA, MPRSA, SDWA, and
RCRA. The water quality standards and effluent guidelines under CWA use fecal
ccliforai bacteria as an indicator of sanitary water quality. Tne water
quality standards are also used for permitting under MPRSA. The SUVA provides
the enforcement authority for the Public Health Service fecal colifcra levels
for drinking water. Both SDWA and CVA regulations, however, only deal with a
limited kind of etiological agent and do not provide a particular classifica-
tion. Etiological agents are used as indicators of water quality only.
The sane types of substances may also soon be regulated by EPA under
RCRA. The agency has already proposed listing (as hazardous wastes)
"infectious wastes generated by certain departments in health care facilities
and veterinary hospitals, by laboratories handling etiologic agents, and by
sewage treatment facilities, unless the wastes were sterilised or
incinerated." The agency has published a list of infectious agents proposed
*,o make solid wa^ste hazardous. The final rule, however, has been delayed
vitil treatment standards for the wastes can be develooed.l*7J
lt?-A5 FH 23087 (May 19, 1980).
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-139-
V. APPENDIX A
SCHEMATIC DIAGRAMS OF KEY LAWS
• Toxic Substances Control Act (TSCA)
• Clean Water Act (CWA)
Safe Drinking Water Act (SDWA)
• Marine Protection, Research, and Sanctuaries Act (MPRSA)
• Resource Conservation and Recovery Act (RCRA)
• Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Clean Air Act (CAA)
• Comprehensive Environmental Response, Compensation and
Liability Act (CERCLA)
• Occupational Safety and Health Act (OSHA)
• Hazardous Materials Transportation Act
• Bulk Flammable and Combustible Liquids Act (3FCLA)
• Dangerous Cargo Act (DCA)
• Port and Waterway Safety Act (PWSA)
• Food, Drug, 'and Cosmetic Act "(FDCA)
• Consumer Product Safety Act (CPSA)
• Federal Hazardous Substances Act (FHSA)
• Flammable Fabrics Act (FFA)
• Atomic Energy Act (AEA)
As a means of further illustrating the different structures of the
chemical control laws, ICF have developed schematic diagrams of the key
authorities. The different geometric symbols used are coded as follows:
"hexagon" = statutory authority to designate or regulate
"octagon" = statutory mandate to designate or regulate
"rectangle" = statutory definition(s)
"parallelogram" - required considerations
"circle" = agency rules or standards
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