Chemical  Substances Designation
Volume II:  EPA
ICF, Inc.
Washington,  DC
Prepared for

Environmental  Protection Agency
Washington, DC
Dec 81
                                                         PB83-130302

                                                 560TIIS82004
                      U.S. DEPARTMENT OF COMMERCE
                    National Technical Information Service

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                                                           PB83-130302
TOXICS INTEGRATION POLICY SERIES                 EPA  560/TIIS-82-004
                CHEMICAL SUBSTANCES  DESIGNATION
                            VOLUME  2:
                              EPA
                        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
                           SPRINGFIELD, VA 22161

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REPORT DOCUMENTATION  »• '<&p"l'r NO,
       PAGE
4. Title »nd Siititi'.te
5-82-Jc
7. Author(s)
         i. M4.I Wl\ I I^W.          "  «i j» .    i
        , EPA - 560/TIIS-82-004   !

  Chemical Substances Designation

  Volume II:   EPA


Bailey,  et al
I 3. ncci0ti*fic*^ Accession No,
I    P883_ 13££02_
j 5. Report Dale   ~    '
!     December 1981
9. Performing Orcamiation Same and Address
                         8. Perform-nc Organisation Rent. No.

                        L       		
                        j 10. P--.(e-,;/TaiWV/Ofk Unit No.
           ICF  Incorporated
           1850 K Street, N.  W.
           Washington, D. C.   20006
                        ! li. Contracted) or Grant(G) No.
                         ,a  68-01-6038
12. Sponsoring Orjjnuntion Nam* and Address
           U.S.  ENVIRONMENTAL-PROTECTION AGENCY
           Office of Toxics  Integration
           Washington, D.  C.   20460
                                                            13. Tygt of Report 4 Period Covered
                                                               Informational
                         14.
15. Supplementary Notes
 id.
   Attract (um,,-. zoo words)  This volume ^  part  of a four voime s tudy ,  examines  EPA and

   other Federal agencies  statutory  and regulatory criteria for the designa-
   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 the
   last section of Volume I,  Volumes II and III review statutory provisions
   and regulations relating to the EPA and other Federal  agency designation
   of chemical substances.  The reviews focus on the criteria used to
   designate   chemicals  for regulation Ce.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 methods
   required  by the regulations,  Volume IV, the chemical  designation  matrix
   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. Identifiers/Open-Ended Terms
   c. CQSATI Field/Group
 13. Availability Statement
                                                19. Security Class (This Resort)

                                               i
                                               i .	  	 ,	
                                               I 20. Security Class (This Pave)
                                                                      21. No. o* Pages
                                  22. Price
(See ANS1-Z39.18)
                                  See Instructions on Reverie
                                  OPTIONAL FORM 272 (4-7;
                                  (Formerly NTIS-35)
                                  Department o' Csmmerce

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                 NOTICE






THIS DOCUMENT HAS BEEN REPRODUCED



FROM  THE  BEST COPY  FURNISHED  US BY




THE SPONSORING AGENCY.  ALTHOUGH IT



IS RECOGNIZED  THAT  CERTAIN  PORTIONS



ARE ILLEGIBLE, IT IS  BEING RELEASED




IN THE INTEREST  OF MAKING AVAILABLE



AS  MUCH INFORMATION AS POSSIBLE.

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                          DISCLAIMER








          The information included in this report include



regulations or policies that were proposed or promulgate 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




chemical substances.   The contents of this report were prepared



under contract to EPA and, though reviewed by EPA and ether



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 ar.d



regulations are reviewed.

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                           Foreword
     A major factor that contributes to integration of EPA
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 W.  Kovalick,  Jr.
                              Director
                              Integration Staff
                              III

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                                   PREFACE
    Volume 2 reviews the statutory provisions and regulations relating to the
Environmental Protection Agency's designation of chemical substances.  The
following EPA authorities are included:

         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 Act of 1980

    The statutory and regulatory reviews are current as of January 1, 1981.

    The statutes are examined to determine the mandates and/or authority for
EPA to designate chemicals as hazardous or toxic substances.  Relevant
legislative history, court cases, and settlements are reviewed to clarify the
legal basis and rationale for statutory provisions.  In addition, rhe chemical
substances covered by the statutes are specified, the statutory definitions of
"hazardous" and "toxic" substances are detailed, the statutory criteria for
designating chemicals for regulation are analyzed, the types of hazards
addressed in the statute are identified, and the statutory bases for
regulatory action are presented.

    Regulations that relate to the designation of hazardous or toxic
substances and are promulgated or proposed under the statutes listed above are
also reviewed.  Regulatory reviews focus on the criteria used by SPA to
designate chemicals for regulation and the chemicals so designated.  This
entails examining chemical definitions, test methods, specific chemical
concentrations which trigger regulatory provisions, as well as health and
welfare effects and regulatory assumptions which are cited as the basis for
designating a chemical.

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                              TABLE OF CONTENTS

                                  VOLUME 2
1.    TOXIC SUBSTANCES CONTROL ACT

         TOXIC SUBSTANCES CONTROL ACT--STATUTORY REVIEW

             Introduction 	   1-1
             Action Under Section 4(a) 	   1-10
             Action Under Section 4(f) 	   1-12
             Action Under Section 5(b)(4)(a) 	   1-12
             Action Under Section 5(e) 	   1-13
             Action Under Section f (f) 	   1-14
             Action Under Section 6(a) 	   1-15
             Action Under Section 6(d)(2) 	   1-17
             Action Under Section 6(e) 	   1-19
             Action Under Section 7 (a) 	   1-19
             Action Under Section 8(c) 	   1-20
             Action Under Section 8(e) 	   1-21

         TOXIC SUBSTANCES CONTROL ACT—REGULATORY REVIEW •

             Introduction 	   1-22
             Section 4 Regulations 	   1-22
             Section 5 Regulations 	   1-32
             Section 6 Regulations 	   1-38

2.    CLEAN WATER ACT

         CLEAN WATER ACT--STATUTORY REVIEW

             Introduction 	   2-1
             Overview of the Clean Water Act 	   2-1
             Mechanisms for Achieving the Goals Set by the
                 Clean Water Act 	   2-3
             Water Quality Related Effluent Standards 	   2-4
             Effluent Limitations '	   2-9
                 Effluent Standards for Existing Sources 	   2-10
                 Effluent Standards for New Sources 	   2-25
                 Effluent Standards for Publicly-Owned
                     Treatment Works 	   2-27
                 Pretreatment Standards 	   2-27
             Oil and Hazardous Substances 	   2-23

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                                   -2-
                        TAELZ OF CONTENTS (Continued)

                                  VOLUME 2

                                                                         Page

         CLEAN WATER ACT—REGULATORY REVIEW

             Introduction 	    2-29
             Effluent Limitations and Performance and
                 Pretreatment Standards 	    2-30
                 Standard Setting Methodology 	    2-35
                 Effluent Limitations for Conventional Pollutants ....    2-36
                 Effluent Limitations for Toxic Pollutants 	    2-39
                 New Source Performance Standards 	    2-41
                 Pretreatment Standards for Existing and New
                     Indirect Dischargers 	    2-43
             Toxic Pollutant Effluent Standards (Section 307)  	    2-47
                 Nine Toxic Pollutants:  Designation and Proposed
                     Effluent Standards 	    2-47
                 Six Toxic Pollutants:  1976 Reproposed Effluent
                     Standards 	    2-56
                 Toxic Pollutant List Revised by the 1977
                     Amendments 7-	    2-63
                 Proposed Revisions of the Toxic Pollutant List 	    2-65
             Designation and Control of Discharges of  Hazardous
                 Substances (Section 311)	    2-72
                 Background	    2-72
                 Designation of Hazardous Substances 	    2-73
                 Proposal to Expand Selection Criteria to
                     Include Carcinogenic Effects 	    2-94
                 Determination of Reportable Quantities 	    2-99
                 Exclusions from Coverage 	    2-106
                 Appendix A-Proposed Methodology for Determining
                     Reportable Quantities for Carcinogens 	    2-117

3.    SAFE DRINKING WATER ACT

         SAFE DRINKING WATER ACT--STATUTORY REVIEW

             Introduction 	    3-1
             National Interim Primary Drinking Water Standards  	    3-2
             Revised Primary Drinking Water Standards  	    3-3
             Secondary Drinking Water Regulations 	    3-5
             Underground Injection Control Regulations  	    3-5
             Bottled Drinking Water Standards  	".    3-6
             Caselaw 	    3-6

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                                   -3-
                        TABLE OF CONTENTS (Continued)

                                  VOLUME 2

                                                                         Page

         SAFE DRINKING WATER ACT—REGULATORY REVIEW

             Introduction 	   3-9
             Specification of Chemicals to be Regulated 	   3-10
             Regulatory Provisions and Status of Regulations  	   3-13
             Summary 	   3-35

4.   MARINE PROTECTION, RESEARCH, AND SANCTUARIES ACT

         MARINE PROTECTION, RESEARCH, AND SANCTUARIES ACT--STATUTORY REVIEW

             Background 	   4-1
             Regulatory Criteria 	   4-1
             Summary 	   4-4

         MARINE PROTECTION, RESEARCH, AND SANCTUARIES ACT--REGULATORY REVIEW

             Introduction 	   4-5
             Summary of Regulations  	   4-5
             Criteria for Permitting 	   4-8
             Environmental Impact Criteria 	   4-9
             Need and Impact Criteria 	•	   4-14
             Summary 	   4-17

5.   RESOURCE CONSERVATION AND RECOVERY ACT

         RESOURCE CONSERVATION AND RECOVERY ACT--STATUTORY REVIEW

             Introduction 	   5-1
             Designation Authority of Section 3001 	   5-2
             Coordination with Other Acts 	   5-3
             Caselaw 	   5-4

         RESOURCE CONSERVATION AND RECOVERY ACT--REGULATORY REVIEW

             Introduction 	   5-6
             Summary of Regulations  	   5-6
             Criteria for Designation 	   5-7
             Lists of Hazardous Wastes 	   5-15
             Appendix A-Measurement of Characteristics and
                 Test Methods 	

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                                   -4-
                        TA3LE OF CONTENTS (Continued)

                                  VOLUME 2

                                                                         Page

6.   FEDERAL INSECTICIDE, FUNGICIDE. AND RODENTICIDE ACT

         FEDERAL INSECTICIDE, FJNGICIDE, AND RODENTICIDE ACT --STATUTORY REVIEW

             Introduction ............................................   6-1
             Background  ..............................................   6-1
             Statutory Provisions ....................................   6-3
             Judicial Interpretations ................................   6-9

         FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT— REGULATORY REVIEW

             Introduction ............................................   6-2.3
             Overview ................................................   6-23
             Chemical Substances Comprising Pesticides  ...............   6-2.5
             Interagency Jurisdiction ................................   6-27
             Registration Procedures and Testing Requirements ........   6-28
             Regulatory Criteria .....................................   6-34
             Other Pesticide Regulations .............................   6-42
             Summary of Pesticides Regulated for Having
                 Unreasonable Adverse Effects  ........................   6-49
             Pesticide and Toxicity Categories  .......................   6-51

7.   CLEAN AIR ACT

         CLEAN AIR ACT— STATUTORY REVIEW

             Overview of the Act .....................................   7-1
             Sections 108-109:  National Ambient Air Quality
                 Standards ......... . .................................   7-2
             Section 110:  State Implementation Plans  ................   7-9
             Section 111:  New Source Performance Standards ..........   7-10
             Section 112:  National Emission Standards  for
                 Hazardous Air Pollutants ............................   7-12
             Section 122:  Listing of Certain  Unregulated
                 Pollutants  ..........................................   7-12
             Section 153, 154, 155, and 157:   Ozone Protection  .......   7-15
             Section 202:  Motor Vehicle Emissions Standards  .........   7-16
             Section 211:  Regulation of Fuels  and Fuel Additives  ....   7-17
             Section 231:  Aircraft Emissions  ...................... ". .   7-2.1
             Overview of Statutory Authority .........................   7-21

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                                   -3-
                         TABL£ OF CONTENTS (Continued)

                                   VOLUME 2

                                                                         Page
         CLEAN AIR ACT—REGULATORY REVIEW

             National Ambient Air Quality Standards
                 Introduction 	   7
                 Overview 	   7-35
                 Chemical-hy-Chemical Analysis 	   7-^2
             New Source Performance Standards
                 Introduction 	   7-63
                 Overview 	   7-63
                 Designated Pollutants 	   7-69
                 Standards 	   7-71
             National Emission Standards for Hazardous Air Pollutants
                 Introduction 	   7-73
                 Overview 	   7-73
                 Designation Critaria 	   7-7a
                 Chemical-by-Chemical Analysis 	   7-79
             Motor Vehicle and Aircraft Emission Standards
                 Motor Vehicle Emissions 	   7-93
                 Aircraft Emissions 	   7-93
             Fuel and Fuel Additives
                 Introduction 	   7-95
                 Background	   7-95
                 Regulation of Fuel and Fuel Additives:  40 CFR SO ...   7-97

8.    COMPREHENSIVE ENVIRONMENTAL RESPONSE,  COMPENSATION, AND LIABILITY ACT

         COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION, AND LIABILITY
         ACT--STATUTORY REVIEW

             Introduction 	   8-1
             Overview of the Statute 	   3-1
             Designation Criteria  	   3-3

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                                   -6-
                               LIST OF EXHIBITS
                                   VOLUME 2
                                                                         Page
EXHIBIT 1-1      Overview of TSCA's Regulatory Approach 	,    1-3

EXHIBIT 1-2      TSCA Section 4(e) Priority List 	    1-24

EXHIBIT 1-3      Tearing Under Section 4 	    1-28

EXHIBIT 2-1      A Summary of Relevant Water Pollution Control
                 Mechanisms 	,	    2-5

EXHIBIT 2-2      Technology Required of Specific Source and
                 Pollutant Types  	    2-11

EXHIBIT 2-3      Regulatory Chronology:  Effluent Limitations,
                 Performance and Pretreatment Standards 	    2-32

EXHIBIT 2-4      Twenty-one Priority Industries Identified in
                 1977 Settlement Agreement 	    2-34

EXHIBIT 2-5      Toxic Pollutants Selected for Study and
                 Regulation Under Toxic Effluent Guidelines  	    2-40

EXHIBIT 2-6      Categories of Sources Requiring NSPS  	    2-42

EXHIBIT 2-7      Section 307 of the Clean Water Act--Regulatory
                 Chronology 	    2-48

EXHIBIT 2-8      Designation Criteria for the Nine Toxic
                 Pollutants 	    2-51

EXHIBIT 2-9  .    Nine Designated Toxic Pollutants and Their
                 Toxicological Effects 	    2-54

EXHIBIT 2-10     Six 1976 Toxic Pollutants and Their Definitions  ....    2-57

EXHIBIT 2-11     Effluent Standards Criteria for the Six
                 Toxic Pollutants  	    2-62

EXHIBIT 2-12     Toxic Pollutant  List As Revised by the 1977
                 Amendments 	    2-64

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                         LIST OF EXHIBITS (Continued)

                                   VOLUME 2
EXHIBIT 2-13     Criteria for Adding Ammonia to the Toxic
                 Polluranr List 	    2-63

EXHIBIT 2-14     Section 311 Hazardous Substances:  Regulatory
                 Chronology 	    2-74

EXHIBIT 2-15     List of Designated Hazardous Substaneas 	    2-77

EXHIBIT 2-16     Toxieological Selection Criteria for Designating
                 Hazardous Substances 	    2-89

EXHIBIT 2-17     Materials Delated Because of Low Potential for
                 Discharge 	    2-91

EXHIBIT 2-13     Carcinogens Proposed as Hazardous Substances 	    2-96

EXHIBIT 2-19     Carcinogens Mot Meeting Discharge Potential
                 Criteria 	    2-98

EXHIBIT 2-20     EPA Categories for Reportable Quantity Determination    2-1G2

EXHIBIT 2-21     EPA Categories for Reportable Quantity •
                 Determinations for Carcinogens 	    2-106

EXHIBIT 2-22     Proposed Reportable Quantities for Hazardous Substances
                 Designated on the Basis of Carcinogenicity 	    2-107

EXHIBIT 2-23     Exceptions to 4Q CTR 117 Regulations 	    2-108

EXHIBIT 3-1      .Chronology of 5DWA Actions and Regulations 	    3-14

EXHIBIT 3-2      Maximum Contaminant Levels for Inorganic Chemicals      3-16

EXHIBIT 3-3      Maximum Contaminant Levels for Fluoride 	    3-20

EXHIBIT 3-4      Max*!""™ Contaminant Levels for Organic
                 Pesticides and Herbicides 	    2-2^

EXHIBIT 3-5      Derivation of Approval Limits for Chlorinated
                 Hydrocarbon Insecticides 	    3-25
EXHIBIT 3-6
Saxinum Contaminant Levels for Radioactive Substances

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                                   -s-
                         LIST OF EXHIBITS (Continued)

                                   VOLUME 2

                                                                         Page

EXHIBIT 3-7      Comparison of Radium Control Limits .................    3-:i9

EXHIBIT 3-3      Secondary Maximum Contaminant Levels .............. ,    3-36

EXHIBIT 3-9      Effects of Chemicals Regulated by Secondary Standards   3-36

EXHIBIT 4-1      MPRSA - Regulatory Chronology ......................    4-6

EXHIBIT 4-2      Limiting Permissible Concentrations ................    4-12

EXHIBIT 5-1      RCRA - Regulatory Chronology .......................    5-8

EXHIBIT 5-2      E? - Toxicity ......................................    5-10

EXHIBIT 5-3      Wastes Designated Under RCHA ......................    5-13

EXHIBIT 5-4      Lists of Hazardous Wastes ..........................    5-16

EXHIBIT 5-5      Exclusions .........................................    5-19

EXHIBIT 6-1      Overview of Statutory Criteria .....................    6-4

EXHIBIT 6-2      Summary of Key Regulatory Actions for Pesticides .  . .    6-26

EXHIBIT 6-3      Summary of Physical and Chemical Properties Data
                 Requirements in 163.61-10 ..........................    6-31

EXHIBIT 6-4      RPAR Criteria ......................................    6-36

EXHIBIT 6-5      Pesticides Selected for RPAR Review ................    6-40

EXHIBIT 6-6      Criteria Under Which a Pesticide May Be
                 Classified for General Use  .........................    6-43

EXHIBIT 6-7      Active Ingredients Classified for Restricted Use .  . .    6-44

EXHIBIT 6-6      Human Hazard Toxicity Categories for Labeling ......    6-46

EXHIBIT 6-9      Labeling:  Environmental Hazards Criteria  ..........    6-48

EXHIBIT 6-10     One Categorization of Pesticides ...................    6-53

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                                   -9-



                           LIST OF EXHIBITS (Continued)

                                     VOLUME 2
EXHIBIT 6-11


EXHIBIT 6-12


EXHIBIT 6-13


EXHIBIT 6-14

EXHIBIT 6-15

EXHIBIT 7-1



EXHIBIT 7-2


EXHIBIT 7-3

EXHIBIT 7-4

EXHIBIT 7-5


EXHIBIT 7-6


EXHIBIT 7-7


EXHIBIT 7-8

EXHIBIT 7-9

EXHIBIT 7-10

EXHIBIT 7-11

EXHIBIT 7-12
FIFHA Human Toxicity Criteria (Inhalation LC.Q) .

?ITRA Human Taxicity Criteria (Acute Oral LD-Q) •

      Human Toxicit? Criteria (Acute Deraal U-)
FIFRA Human Toxicity Critaria (Eye Effects)

FIFRA Human Toxicity Criteria (Skin Effects)
Effects Threshold, 3est Choice Significant Risk
Levels, and Safety Margins Contained in Primary
Air Quality Standards (1974) 	
Statutory Critaria for Regulating Fuels and
Fuel Additives 	
Overview of Clean Air Act Regulatory Authority

Sections 110, 111, and 112 Contrasted	
Regulatory Chronology:  National Ambient Air
Quality Standards 	
National Ambient Air Quality Standards Implementa-
tion of Health and Welfare Effects Criteria 	
Summary:  National Primary and Secondary Ambient
Air Quality Standards 	
Effects of Sulfur Oxides on Health
Effects of Particulate Matter on Health .

Human Health Effects of Nitrogen Dioxide

Low-Exposure Health Effects of Lead 	
 -


6-55


5-56


6-57

6-58
 '-IS
EPA Considerations in Developing the Lead
Priaiarv Standard 	
7-29


7-36


7-39


7-40

7-43

7-48

7 -62

7-64


7-65
EXHIBIT 7-13
NSPS Designation Critaria

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                                   -10-
                           LIST OF EXHIBITS (Continued)

                                     VOLUME 2

                                                                         Page

EXHIBIT 7-14     Regulatory Chronology:  Narional Emission
                 Standards for Hazardous Air Pollutants 	    7-75

EXHIBIT 7-15     Summary:  Listing Criteria and Emissions
                 Standards Criteria for Hazardous Air Pollutants ....    7-77

EXHIBIT 7-16     Regulator? Chronology  	    7-96

EXHIBIT 7-17     Medical-Scientific Evidence That Lead Emissions
                 Pose Health Risks 	    7-100

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               TOXIC SUBSTANCES CONTROL ACT--STATUTORY REVIEW
    The Toxic Substances Control Act (TSCA)1J  authorizes the EPA to
regulate "chemical substances and mixtures."  The Act states:

              It is the policy of the United States that adequate
         authority should exist to regulate chemical substances and
         mixtures which present an unreasonable risk of injury to
         health or the environment, and to take action with  respect
         to chemical substances and mixtures which are an imminent
         hazard . . ,  [Section 2(b)(2)]

The following discussion focuses on five elements of TSCA:

         •    What kind of agency regulation is authorized or
              required?

         •    To what activity and/or subject matter is the  acticn
              directed?

         •    What kind of harm is" sought  to be avoided?

         •    What level of causality must exist between this
              activity/subject matter and  the harm involved?

         •    What criteria or factors must be taken into
              consideration before the action is taken?

There is little case law directly relevant to this discussion.  Explanatory
comments, therefore, rely primarily on TSCA's legislative history.

INTRODUCTION

    Under TSCA, EPA is required (i.e., mandated) or authorized (i.e.,
permitted) to take a variety of regulatory actions regarding chemical
substances and mixtures.  Those actions include requirements for testing  ar.d
data submission, prohibition or limitation of activities involving chemical
substances and mixtures, and imposition of reporting and recordkeeping
requirements.  EPA also is given authority to develop lists  of chemical
substances or mixtures that are to be given special regulatory treatment.
     1J 15 USC §§ 2601-2529).

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                                   1-2

    The subject matter with which TSCA is concerned, as noted above, is "chem-
ical substances and mixtures."2-  In a few instances, the subject matter is
extended to include "articles" containing the chemical substances or mixture,
as well as "categories of chemical substances or mixtures."3J  All
regulatory actions autaorized or required to be taken by EPA with respect to a
chemical substance or mixture are applicable also to "categories of chemical
substances or mixtures" (Section 26(c)).

    It is specific activities or risks or combinations of activities and risks
involving chemical substances and mixtures that trigger TSCA requirements.  In
particular, the specific activities are the manufacture (defined in Section
3(7)), distribution in commerce (defined in Section 3(4)),  processing  (defined
in Section 3(10)), use, or disposal of chemical substances and mixtures, or
any combination of these activities.

    The kind of harm most often addressed by TSCA is termed "an unreasonable
risk of injury to health or the environment."  "Unreasonable risk" is  not
defined in TSCA.  The House Report indicates the following reason for  this
intentional omission:
    2"Chemical substance" is defined (Section 3(2)) to mean "any organic or
inorganic substance of a particular molecular identity.  ..."  This includes
combinations of organic and inorganic substances that are wholly or partially
the result of a chemical reaction or which occur in nature.  The definition
also includes "any element or uncombined radical."  Some items are specifi-
cally excluded from the definition, including mixtures, pesticides, tobacco,
and nuclear material.

    "Mixture" is defined (Section 3(8)) as "any combination" of chemical sub-
stances if that combination is not naturally occurring or not in part or in
whole the result of a chemical reaction.  However, reaction-produced combina-
tions are included in the definition of mixture if they are not comprised of
any new chemical substances and if such a combination could have been produced
without a chemical reaction.  The reason for this exception is "to prevent
disparate treatment of identical combinations simply because of the number of
steps used in the manufacture of the combination."  ( Legislative History, r>.
670.)

    '"Category of chemical substances" is defined (Section 26 (c)(2)(A)) to
mean "a group of chemical substances the members of which are similar in
molecular structure, in physical, chemical, or biological properties, in use,
or in mode of entrance into the human body or into the environment, or the
members of which are in some other way suitable for classification as such for
purposes of this Act, except that such term does not mean a group of chemical
substances which are grouped together solely on the basis of their being new
chemical substances."

    "Category of mixtures" is defined  (Section 26(c)(2)(B))" to mean "a group
of mixtures the members of which are similar in molecular structure, in physi-
cal, chemical, or biological properties, in use, or in the mode of entrance
into the human body or into the environment, or the members of which are in
some other way suitable for classification as such for purposes of this Act."

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                                   1-3

         [T]he determination of unreasonable risk involves a. consid-
         eration 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 judgment
         on the part of the person making it. ...  [ Legislative
         History, pp. 421-422]

More specifically, the House Report indicated what factors should generally be
weighed in making the determination that an unreasonable risk exists.  Such a
determination involves

         balancing the probability that harm will occur and the
         magnitude 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. 422]

    Thus, "unreasonable risk" is not a uniform or rigid concept.  The House
Report states that

         [a]lthough the standard for defining the regulatory author-
         ity of [EPA] .  .  .  throughout the bill is "unreasonable
         risk," the implementation of the standard will of necessity
         vary depending on the specific regulatory authority which
         [EPA] .  . . seeks to exercise.  [ Legislative History, p.
         422]

    In practical terms this  suggests that the less negative impact a
regulatory action by EPA will have, the easier it will be for EPA to make the
determination that there is  an unreasonable risk.  Other formulations of harm
to health and the environment are mentioned in individual situations, but none
is as pervasive as "unreasonable risk."  Those other formulations will be
discussed as appropriate.

    The level of causality required to trigger agency action varies, but one
formulation is used most frequently:  "presents an unreasonable risk."  The
conference committee selected the term "presents" and rejected the phrase
"cause or significantly contribute to . . ."  The- intention of the conferees
in selecting the term "presents" was

         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, p. 673]

-------
                                   1-4

There are other levels of causation that are required for specific  regulatory
actions, but "presents" is the most frequently used.  The other formulations
for causation will be discussed as appropriate.

    Section 2(c) of TSCA sets out the general factors that EPA is to consider
in administering the Act.  ZPA "shall carry out this Act in a reasonable  and
prudent manner, and .  .  . shall consider the environmental, economic,  and
social impact of any action  [EPA] .  . . takes or proposes to take under this
Act."  This suggests that TSCA regulatory actions are to involve some
balancing of costs and benefits.  However, a formal cost benefit analysis is
not required.  Tae House Report indicates

         that the bill is not to be construed as a direction to
         [EPA]  ... to make any statement of findings  in addition
         to those required by specific provisions of the bill or to
         involve [SPA] ... in any cost-benefit justifications.
         [ Legislative History, p. 471]

    Exhibit 1-1 summarizes TSCA's approach to the regulation of chem-
ical substances and mixtures which pose some level of harm to health or the
environment.  As noted above, the phrase "unreasonable  risk of injury" is used
frequently, but may have different meanings in different situations.   The exhi-
bit below indicates what these differences are in the column that summarizes
what criteria must be met before action is taken.  It will be obvious  that the
criteria for the different actions will vary considerably even though  the hara
involved in each is an "unreasonable risk of injury."   Each entry in the
exhibit receives detailed attention in the discussion immediately following.

    There are many individual situations where TSCA authorizes or requires
agency action.  These situations are discussed below in terms of the five ele-
ments just outlined.  The specific discussion focuses on Sections 4-3  of  the
Act, which set out most of the actions necessary to address risks posed by
chemical substances and mixtures.  Unless otherwise noted, all section refer-
ences are to the Act.

-------
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                                   1-9

ACTION UNDER -SECTION 4 (a)

    Under two circumstances, EPA is directed to require by rule that chemical
substances or mixtures be tested (4(a)(l)).  First, if EPA finds that:

         •    the manufacture, processing, distribution in
              commerce, use, or disposal of the substance or
              mixture, or any combination of these activities may
              present an unreasonable risk of injury to health or
              the environment;

         •    there is insufficient data and experience to make a
              reasonable determination or prediction of the health
              and environmental effects of the substance or mixture;
              and

         •    testing is needed to provide sufficient data;

then testing must be required (4(a)(1)(A)).  Alternatively, if EPA
finds that:

         •    a chemical substance or mixture is produced in
              substantial quantities and it enters the environment
              in substantial quantities or there is substantial or
              significant human exposure to the chemical;

         •    there is insufficient data and experience to make a
              reasonable determination or prediction of the health
              and environmental effects of the substance or mixture;
              and

         •    testing is needed to develop this information;

then testing must be required (4(a)(1)(B)).

The kind of harm sought to be avoided is the same under both alternatives:
"an unreasonable risk of injury to health or the environment."  The general
meaning of this phrase was discussed above.  By using it in Section
4(a)(l)(A), the conference committee indicated an intention

         to focus [EPA's] . .  . attention on those chemical substan-
         ces and mixtures about which there is a basis for concern,
         but about which there is inadequate information to reasona-
         bly predict or determine their effects on health or the
         environment. [EPA] .  . . need not show that the substance
         or mixture does or will present a risk.   [ Legislative
         History, p. 674]

    As the conferees noted, "there are certain situations in which testing
should be conducted even though there is an absence of information indicating
that the substance or mixture per se may be hazardous."  ( Legislative
History, id.)

-------
                                   1-10

    The level of causality that must exist between the chemical substance  (or
mixture) and the unreasonable risk of irpury.  The testing requirement must
be imposed if the chemical "may present" the unreasonable risk.  The use and
meaning cf "presents" was discussed earlier.  The use of the conditional "may"
reflects Congress' intent (illustrated in the passages just quoted) that this
requirement can be triggered even when there is uncertainty about the health
and environmental effects of a chemical.

    The legislative history of "may present" in Section 4 is quite
interesting.  The Toxic Substances Control Act of 1975, H.R. 7664, which was
not enacted, authorized a testing rule when "necessary to protect against"
unreasonable risk to health or the environment.*J  The House Committee the
next year adopted, instead, the words "may cause or significantly contribute
to" an unreasonable risk.  The members of the Committee reasoned that if
action were "necessary to protect against unreasonable risk to health or the
environment," presumably EPA would take action under Section 6.SJ

    The House Report briefly discuss-es the choice of the word "may."

              It should be noted that 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
         term "may" as used in the phrase "may cause or signifi-
         cantly contribute to" does not permit 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]

  '  Ultimately, though, the conference committee adopted the Senate language
"may present" in lieu of "may cause or significantly 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.
    fcj Legislative History, p. 489.

    5J Ibid.

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                                   1-11

              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 Administrator have authority to protect
         health and the environment in such situations.
         [Legislative History, pp. 673-4.]

The criteria or factors to be considered in requiring testing:  Section 4(b)
details required considerations for setting rules to govern testing.
Development of the testing rules must include consideration of "the relative
costs of the .  .  .  test protocols and methodologies which may be required
under the rule and the reasonably foreseeable availability of the facilities
and personnel" necessary for the testing required by the rule (4(b)(l)).

    Although this suggests that TSCA regulatory actions are to involve some
moderation and balancing, the House Report specifically states that the
determination of unreasonable risk under Section 4(a):

              .  . .  does not require a formal benefit-cost analysis
         under which a monetary value is assigned to the risks
         associated with a substance and to the cost to society of
         proposed regulatory action on the availability of such
         benefits.   Because a monetary value often cannot be
         assigned to a benefit or cost, such an analysis would not
         be very useful.  [Legislative History, p. 422]

    It is interesting to note that under Section 4(a) of the Senate Ccrnmittae
bill, S.3149, the Administrator was specifically instructed to "consider the
reasonably ascartainable costs and other burdens associated with conducting
such tests in light of the possible risks of injury to health or the
environment and . .  . [to] publish the same in the Federal Register."  This
requirement, however, was not included in the final TSCA that emerged from the
Conference Committee.

    Finally, "unreasonable risk" is not to be construed as a uniform or rigid
concept.  The House Report states that

              [a]lthough the standard for defining the regulatory
         authority of the Administrator throughout the bill is
         "unreasonable risk," the implementation of the standard
         will of necessity vary depending on the specific regulatory
         authority which the Administrator seeks to exercise.  For
         example, a testing rule under Section ^ will ordinarily
         ncz result in depriving the public of the benefits of a
         substance or mixture subject to the rule.  This is because
         such a rule doe not prohibit the manufacture, processing,
         etc.,  of existing substances or of mixtures . . .

              However, this is to be contrasted with the effect of
         the imposition of a requirement under Section 6 on a
         substance.   Such a requirement may remove a substance from

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                                   1-12

         the market or impose lesser restrictions on its
         availability and such a requirement is not of limited
         duration.  Thus, the effect on society may be far reaching.
         As a result .  .  .  because the regulatory effect of action
         taken under [Section 4] ... is less than that of action
         taken under Section 6,  the requirements for a determination
         of unreasonable risk for purposes of Section 4 .  .  . are
         less deaanding.   [Legislative History, pp. 422-3]

ACTION7 UNDE5 SECTION 4(f)

    If EPA receives test data submitted under TSCA or any other information
that indicates "that there may be a reasonable basis to conclude that a
chemical substance or mixture presents or will present a significant risk of
serious or widespread harm to human[s] .  .  . from cancer,  gene mutations, or
birth defects," EPA must initiate appropriate action under Sections 5, 6, or  7
or publish a finding that the risk is not unreasonable.

    The kind of harm sought to be avoided:   The harm involved in this
situation is  'a significant risk of serious or widespread harm to human beings
from cancer, gene mutations, or birth defects. ..."  This is a more narrowly
defined risk than that comprehended by the term "unreasonable risk."  The type
of injury is limited to cancer,  gene mutations, and birth defects; the
potential injury must be serious or widespread; and the risk must be
"significant."

    The level of causality that must exist between the chemical substance and
mixture and the significant risk of serious or widespread harm from cancer,
gene mutations, or birth defects:  EPA action must be taken if the chemical
"presents or will present" the harm to be avoided.  The causal connection
must, therefore, be more certain than under Section 4(a) where "may present"
was sufficient causality to trigger EPA action.

    The criteria or factors to be considered:  EPA must have a "reasonable
basis to conclude" that the requisite harm, causality, and risk exist.
Further, EPA's action must be such as to reduce to a "sufficient extent" the
risks involved.  EPA does not have to act if it determines that the risk
involved is not "unreasonable."

ACTION UNDER SECTION 5(b)(A)(A)

    EPA may, by rule, compile and update a list of certain chemical substances
for which EPA finds the manufacture, processing, distribution in commerce,
use, disposal, or combination of these activities "presents or may present" an
unreasonable risk of injury to health or the environment  (5(b)(4)(A)).  If  a
chemical substance is on this list and no Section 4 testing rule has been
promulgated for it before a premanufacturing notice'-1 regarding it is
    8JSection 5(a) requires a person planning to manufacture a new  chemical
or planning to manufacture or process a chemical for a significant  new use  to
provide EPA with a notice containing certain information.

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                                   1-13

submitted, the submitter must provide EPA with data that shows that the
chemical substance does not present an unreasonable risk of injury.

    The kind of harm sought to be avoided:  The harm involved in this
situation is the frequently used and previously discussed "unreasonable risk
of injury to health or the environment."

    The level of causality that must exist between activities with the
chemical substance and the unreasonable risk of injury:  EPA may add the
chemical substance to the list if activity with the chemical "presents or may
present" the harm to be avoided.  The causal connection between the activity
and the harm, therefore, need not be relatively certain.

    The criteria or factors to be considered:  Any such finding by EPA that
supports its action to compile a list must include all "relevant factors"
including "the effects of the chemical substance on health [and the
environment] and the magnitude of human [and environmental] exposures" to the
chemical substance.  (Section 5(b)(4)(A)(ii))

ACTION UNDER SECTION 5(e)

    If EPA lacks the information necessary to make a reasoned evaluation of
the health and environmental effects of a chemical substance for which a
premanufacturing notice is required to be submitted, there are two instances
in which EPA may, by proposed order,'limit or prohibit the manufacture,
distribution in commerce, processing, use, or disposal of such a
chemical.7-   The two instances are:
    7JThere are limits to EPA's authority to issue such a proposed order.
One commentator notes:
    [T]he rules for imposition of an immediate restriction on a chemical  [are]
change[d] if EPA acts after 45 days prior to expiration of the
[premanufacturing] notice period.  Section S(e)(l)(3).  At that point, the
substantive criteria for action become stricter.
    If the agency wants to act when there are 45 or fewer days left in the
premanufacturing notice period, two criteria must be met for EPA to prohibit
manufacture, processing, or distribution of a chemical:  (1) EPA must declare
a proposed rule (imposing these sanctions) to be effective upon publication in
the Federal Register, and (2) a court must have found that the chemical
subject to this rule poses "an imminent and unreasonable risk of serious  or
widespread injury to health or the environment."  Sections 6(d)(2)(A)(ii),
7(a),(f).  If the sanctions EPA seeks to impose are less severe than  a
prohibition., the agency still must find that there is "an unreasonable risk of
serious or widespread injury to health or the environment."  Section
6(d)(2)(A)(i).   If EPA acts before the 45 day period begins, it need  not  find
that the potential injury is imminent, widespread, or serious--it merely  must
find that the risk of injury is unreasonable, or that the chemical will be
produced in substantial quantities or that human or environmental exposure
will be substantial.  (See the text following this note).  Zener, "The Toxic
Substances Control Act," 22 The Business Lawyer 1635, 1695 (1977).

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                                   1-14

         •    The lack of necessary information leaves open the
              possibility that these activities may present an
              unreasonable risk of injury to health or the
              environment.

         •    The production quantities of the chemical substance
              are or will be substantial, the chemical is or can
              reasonably be expected to enter the environment in
              substantial quantities, and human exposure to it is or
              may be significant or substantial.

    This authority differs from Section 4(a) which applies to all chemicals.
Under Section 5(e),  only new chemicals or existing chemicals which are being
considered for a significant new use are covered.  It might be thought that
Section 4(a) could cover these, too, but Section 4(a) is limited to (1)
chemicals about which enough is known to cause some concern and to radicate
that more information is needed (see Legislative History, p. 424), and (2)
chemicals produced in large quantities.  New chemicals or chemicals for
significant new uses, the subject of Section 5(e), may fit neither of these
categories.

    The kind of harm sought to be avoided:  This situation is very similar to
Section 4(a).   The same harm is involved--"an unreasonable risk of injury."

    The level of causality that must exist between a chemical substance and
the unreasonable risk of injury or the substantial exposure:  The required
level of causality is, as with most situations under TSCA, fairly low.  The
chemical substance is subject to EPA action if it "may present" an
unreasonable risk, if the exposure of the environment occurs or "may
reasonably be anticipated" to occur, and if significant or substantial human
exposure occurs or "may" occur.

    The criteria or factors to be considered:  Tae action must be based on a
determination by EPA that:

         (1)  there is insufficient information to make a
              "reasonable evaluation" of the chemical substance's
              effect on health and the environment, and
         (2)
without being able to make the necessary evaluation,
the harm sought to be avoided "may" occur.
This two-part test indicates that agency action is justified if there  is going
to be a certain level of human and environmental exposure without enough
information to determine whether any potential harm may come from the  exposure.

ACTION UNDER SECTION 5(f)

    If EPA finds that there _is an unreasonable risk of injury involved in  the
manufacture, processing, distribution in commerce, use, or disposal of a new
chemical substance or a chemical substance for a significant new use,  and  if

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                                   1-15

it finds that this risk occurs before a Saction 6 nils can provide protection,
then EPA must take one of two actions:

              •    issue a proposed rule under Section 6 (a)
                   (related to the regulation of hazardous chemicals
                   and substances) that may limit (bur not prohibit)
                   activity related to the chemical substance and
                   which will be effective upon its publication in
                   the Federal Register; or

              •    issue a proposed order to prohibit the
                   manufacture, processing, or distribution of the
                   chemical substance.1-1

    The kind of harm sought to be avoided:  EPA is to act to avert an
"unreasonable risk of injury to health or environment."  This is the harm with
which TSCA is most frequently concerned, and it has been discussed previously.

    The level of causality that must exist between activities with the
chemical substance and the unreasonable risk of injury:  The activity related
to the chemical substance will be limited or prohibited if it ''presents or
will present" an unreasonable risk of injury.  The causal link must be more
certain than when the criterion is "may present."  This is in keeping with the
Congressional intent to require a stronger causal link between the chemical
and the harm where the action EPA can take is more severe.

    The criteria or factors to be considered:  EPA must have a "reasonable
basis" for concluding that an "unreasonable risk of injury" is involved.  In
addition, the harm must be fairly imminent--occurring before a Section 6 rule
could rectify the situation.  Although the term "imminent" is not used in the
section, the conference report indicates that that is the situation
contemplated by this section.  (See Legislative History, p. 683)

   • Although a similar authority to make a proposed rule effective upon publi-
cation exists under Section 6(d), Section 5(f) differs in that it requires
only an "imminent, unreasonable risk of injury, regardless of whether the
injury will be serious or widespread," ( Legislative History, id.) and
involves only new chemicals or chemicals to be put to a significant new use.
Under Section 6(d) the injury must be serious or widespread, but Section 6(d)
is applicable to all chemicals.

ACTION UNDER SECTION 6(a)

    EPA is required, by rule, to place a variety of restrictions on the manu-
facture, processing, distribution, use, or disposal of a chemical substance or
mixture, or any combination of these activities, whenever it has a reasonable
basis for concluding that any of these activities presents or will present an
    1JE?A's authority to issue a prohibitory order is limited by the i-5 day
period discussed in footnote 4.

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                                   1-16

unreasonable risk of injury to health or the environment.  The restrictions
include prohibitions or limitations on these activities, markings and warnings
to be placed on the chemical substance or mixture, various levels of record-
keeping, and some notification requirements.

    The kind of harm sought to be avoided:  Again, the harm to be protected
against is "an unreasonable risk of injury to health or the environment."  The
meaning of this phrase has been discussed previously.  The Section 6 title
refers to the substances subject to regulation as "hazardous chemical
substances or mixtures."

    The level of causality that must exist between activities and the
unreasonable risk:  The causation requirement is  presents or will present an
unreasonable risk."  The meaning of this phrase also has been previously
discussed.

    The criteria or factors to be considered:  EPA must have a "reasonable
basis" for concluding that an unreasonable risk exists.  In deciding which
regulatory restriction to impose, EPA must select the restriction that both
protects "adequately" against the risk and imposes "the least burdensome
requirements."  These general directives are supplemented by a list of
explicit considerations (6(c)(l)) that EPA must make and publish in
promulgating a Section 6 rule:

         •    the effects the chemical substance or mixture has on
              health and the environment and the magnitude of human
              and environmental exposure to the chemical substance
              or mixture;

         •    the "benefits" the chemical substance or mixture has
              for "various uses," and the availability of
              substitutes for their uses; and

         •    "the reasonably ascertainable economic consequences
              of" the Section 6(a) rule, taking into consideration
              its effect on "the national economy, small businesses,
              technological innovation,  the environment, and public
              health."

Further, if EPA determines that the risk involved is "eliminated" or suffi-
ciently reduced by other legislation administered wholly or in part by EPA,
EPA may not promulgate a Section 6 (a) rule unless it finds, in its
discretion, that the public interest requires application of TSCA to prevent
the risk.  (6(c)(l)).  In making this finding, EPA must consider (but evidently
need not publish):

         •    "all relevant aspects of the risk," as determined by
              EPA in EPA's discretion;

         •    comparison of estimated compliance costs under TSCA
              and under the other  relevant statutes; and

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                                   1-17

         •    the "relative efficiency" of actions under TSCA
              versus under the other relevant statutes.
                                              t

The statement EPA is required to publish is not to be a formal, detailed
report.  The conference report indicated that a "succinct and precise state-
ment of these key considerations will suffice."  The cost to the industry is
to be considered; the Senate Report suggests that "it is expected that the
chemical industry will come forward with data bearing on the actual costs of
compliance."  ( Legislative History, p. 176)  Presumably, industry recalci-
trance in providing such information would limit industry's ability to attack
successfully EPA's consideration of relative compliance costs.

ACTION UNDER SECTION 6Cb)

    SPA, fay order, may require a manufacturer or processor of a chemical sub-
stance or mixture to submit a description of its quality control procedures,
if EPA has reasonably concluded that the manufacture or processing of the
chemical is done in a manner that unintentionally causes the chemical to
present or will cause it to present an unreasonable risk of injury to health
or the environment.  After reviewing these procedures, EPA may order their
revision, and may require the manufacturer or processor to give notice to
processors, distributors, exposed individuals, and the public regarding the
risk associated with the chemical substance or mixture, and co provide any
replacement or repurchase necessary.

    The kind of harm sought to be avoided:  The h-arm to be avoided is
"unreasonable risk of injury to health or the environment," a concept
previously discussed.

    The level of causality that must exist between the manufacture or
processing of the chemical and the unreasonable risk:  EPA may take this
regulatory action in the face of a manufacturing or processing procedure
"which unintentionally causes the chemical substance or mixture to present
or which will cause it to present an unreasonable risk of injury to health
or the environment. ..." (emphasis added)  The causal link must be strong.
The manner of manufacture or processing must actually cause the risk of injury
to be presented.  It is not sufficient that the production practices in
question "may" cause the risk.

    The criteria or factors to be considered:  EPA must have a "reasonable
basis'  for concluding that the harm is being caused by the manner in which the
chemical substance is being manufactured or processed.  In addition, the
determination by EPA that the quality control procedures in question are
inadequate must be made on the record following a hearing that has been held
in accordance with the Administrative Procedures Act.

ACTION UNDER SECTION 6(d)(2)

    If EPA determines that the manufacture, processing, distribution in
commerce, use, or disposal of a chemical substance or mixture subject to a
proposed 6(a) rule, is likely to result in an unreasonable risk of serious or

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                                   1-18

widespread injury before the 6(a) rule is final, and if the public interest
requires it. EPA may make the proposed 6(a) rule effective immediately upon
its publication in the Federal Register.ij

    The kind of harm soueht to be avoided:  The harm protected against is "an
unreasonable risk of serious or widespread injury to health or the
environment."  Note that this harm criterion is more restrictive than the
usual "unreasonable risk of injury to health or the environment."  Instead of
any injury, it must be "serious or widespread."

    The level of causality:  The level of causation is that the manufacture,
distribution in commerce, processing, use, or disposal of a chemical substance
or mixture, or any combination of these activities, "is likely to result" in
the harm mentioned.  This level of causation is more rigorous than the normal
"will or may present an unreasonable risk."  Instead, EPA may take this action
only if the activities are "likely to result" (unfortunately, the legislative
history provides no interpretation of this term) in the unreasonable risk of
the widespread or serious injury.

    The criteria or factors to be considered:  The harm must be "likely to
result" before the aate when the proposed rule would become final, and EPA
must determine that the early effective date is "necessary to protect the
public interest."  In addition, if the proposed Section 6(a) rule would
prohibit the manufacture, processing, or distribution of a chemical substance
or mixture because of the unreasonable risk of serious or widespread injury, a
court must already have granted relief (including a court order that the
manufacturer, processor, or distributor provide notice of the risk to
purchasers and the public, issue a recall, or replace or repurchase the
chemical involved) under Section 7 of TSCA regarding this unreasonable risk
before EPA can make the proposed rule immediately effective.  The reason for
this requirement is noted in the House Report:

         It is because of the severity of a rule which prohibits the
         manufacture, processing, or distribution in commerce of a
         substance or mixture, that the Committee required an action
         be brought under section 7 (imminent hazard) to have a
         federal district court find that the substance or mixture
         is an imminent hazard.  [The action need not be brought
         against all persons involved in manufacturing, processing
         or distributing the chemical.] .  .  .  Once a court finds an
         imminent hazard in the action under Section 7, a banning
         rule of general applicability may then be made immediately
         effective with respect to all others.  [ Legislative
         History, p. *46]
    5JFailure to take this action authorized by Section 6(d)(2)(A)(i)
obligates EPA to bring the civil suit authorized in Section  7(a).   See the
discussion of Section 7(a), below.

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                                   1-19

ACTION UNDES SECTION 5(a)

    EPA is given broad regulatory authority over polychlorinated biphenyls
(PCBs).  EPA must regulate the disposal of PCBs and must require warnings and
instructions to accompany PCBs.  In addition, EPA may exempt some activity
with PCBs from statutory prohibitions (6(e)(2)(3)), and authorize some use of
PCBs other than in a totally-enclosed manner (6(e)(3)(B).

    The kind of harm sought to be avoided:  The well-documented hazards posed
by PCBs were the impetus for this section.  Exemptions from statutory
prohibitions and authorizations for non-totally-enclosed uses are based, in
part, on an avoidance of "an unreasonable risk of injury to health or the
environment."

    Certainty/causality criteria:  EPA may grant (3)(B) exemptions or
authorize (2)(B) uses if EPA finds that an unreasonable risk of injury to
health or the environment "would not result" and "will [not be] present,"
respectively.  These are criteria for which there is little tolerance for
uncertainty.

    Factors to be considered:  Apart from the criteria listed above, Section
6(e) contains no factors for consideration in establishing PC3 rules under
TSCA.  To implement the authority, EPA employed the factors listed in Section
6(c)(l) for making the required unreasonable risk findings under Section
6(e).  (See review of these factors in Section 6(a) regulatory authority,
above.)  The Circuit Court of Appeals for the District of Columbia declarad
this to be "entirely appropriate" and held that EPA properly applied these
factors.J"J   To exempt "totally enclosed" uses, furthermore, EPA must, by
rule, determine that "any exposure of human beings or the environment to a
polychorinated biphenyl will be insignificant."  (6(e)(2) (C)).  The Court is
given free rein to place any terms and conditions on such an exemption.

ACTION UNDER SECTION 7(a)

    EPA is given authority to bring a civil suit to seize an imminently
hazardous chemical substance or mixture or any article containing such a
substance or mixture and/or obtain appropriate relief11-1  against persons
manufacturing, distributing in commerce, processing, using, or disposing such
a substance, mixture, or article.  EPA must take this action if it has net
made a proposed section 6(a) rule immediately effective when an imminently
hazardous chemical substance or mixture is involved.
           v. SPA, 15 ERC 1081, 1088 (D.C. Cir. 1930).
    1IJSuch other relief includes a requirement that notification of the
risks involved be given to purchasers of the imminently, hazardous chemical,
that there be public notice of such risk, that the chemical be recalled, that
the chemical be replaced or repurchased, some combination of these rsinecias,
or that the chemical be seized or condemned.  (7(b)(2)  and (3))

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                                   1-20

    The kind of harm sought to be avoided:  The harm to be protected against
is an "im.Ti7ient and unreasonable risk of serious or widespread injury to
health or the environment."  The Conference Report notes that the physical
manifestations of the injury need not be imminent, and that "widespread" can
mean "risk of harm affecting a substantial number of people, even though" they
are within a limited geographic area.  ( Legislative History, p. 691)

    The level of causality that must exist between activities involving the
chemical and the -imminent hazard posed bv the chemical:  The level of
causality required is that the imminent hazard must be "presented" by the
chemical substance or mixture in question.  Imminence is considered to be
present if the activities related to the chemical substance or mixture are
"likely to result" in the harm before a final Section 6 rule can protect
against the risk.  The House Report notes that "[sjuch protection would not
necessarily occur upon the effective date of a rule under Section 6.  Instead,
consideration must be given to the time it may take to implement and enforce
such a rule."  ( Legislative History, pp. 447-448)

    The criteria or factors to be considered:  A federal district court must
determine that the manufacture, processing, distribution, use, or disposal of
such a chemical substance or mixture "is likely to result in an unreasonable
risk of widespread or serious injury before a final rule under section 6 can
protect against such risk."

ACTION UNDER SECTION 8(c)

    EPA is to define by rule what is a "significant adverse reaction" for
which records must be maintained by a person who manufactures, processes, or
distributes in commerce a chemical substance or mixture.

    The kind of harm sought to be avoided:  The records must be kept for
significant adverse reactions.

    The level of causality that must exist between the substance or mixture
and the adverse reaction:  Records must be kept for significant adverse
reactions "alleged to have been caused" by a chemical substance or mixture.
This is a fairly loose causal requirement.  However, in keeping with the
rationale behind the Act, the impact on the manufacturer, processor, or
distributor is fairly small, so the loose causal requirement is justified.

    The criteria or factors to be considered:  In determining what is a
"significant adverse reaction," the Conference Report indicated that EPA
should consider the "seriousness, duration, and the frequency" of the
reactions.  The Report supplied an example:

          [I]f an individual reports that a chemical substance causes
         his or her eyes to become inflamed-and to tear, such
         reaction may be attributed to an isolated allergic
         reaction.  However, if several persons report a similar
         reaction, then the reaction may indeed be significant.
         Because the ultimate significance of adverse reactions is

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                                   1-21

         difficult to predict, the conferees intend that the
         requirement to retain records err on the side of safety.
         Some very serious neurological disorders, for insrance, at
         first, present what appear to be trifling symptoms."
         [ Legislative History, p. 694]

ACTION UNDER SECTION 8(a)

    A person who manufactures, processes, or distributes a chemical substance
or mixture in commerce is required to report to EPA information about whether
the chemical presents a substantial risk of injury.

    The kind of hara sought to be avoided:  The hara involved is "a
substantial risk of injury to health or the environment."  The language of
risk is similar to that found in Section 4(f) (discussed above).  There the
risk was described as "significant," and seems to relate to probability of
harm.  In addition, the sanction or burden imposed under Section 4(f) (i.e.,
appropriate action under Sections 5, 6, or 7--including prohibitions on the
manufacture of chemicals) is more severe than the burden imposed by Section
8(e) (reports to EPA).  As noted earlier, when the burden imposed on persons
by TSCA is not great, EPA is not held to as strict a standard of showing that
the harm should be the subject of regulatory action.  (See Legislativa
History, p. 422)  Thus, EPA is probably not required to find a high
probability of injury in determining that a "substantial" risk exists.  The
Senate committee registered its concern that the Kepone situation--where an
empLoyee complaint to the Labor Department was not given proper attention--not
be repeated.  Section 8(e) is designed to avoid a recurrence of the Kepone-
type situation.

    The level of causality required to exist between the chemical and the
risk of harm:  As with much of TSCA, the requirements of the section are
triggered if the chemical "presents" the risk of harm.

    The criteria or factors to be considered:  The information (about the
existence of a substantial risk) received by the manufacturer, processor, or
distributor must "reasonably" support the conclusion that there is the
necessary "substantial risk of injury."  The person does not have to report
the information if he/she has "actual knowledge" that EPA has been ade-
quately informed of the relevant facts.

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                                   1-22
              TOXIC SUBSTANCES CONTROL ACT -- REGULATORY REVIEW
INTRODUCTION

     This section summarizes the designation of chemicals under Sections 4, 5,
and 6 of the Toxic Substances Control Act (TSCA).   We begin with some brief
background on the regulatory process of designating chemicals, and then turn
to a discussion of the criteria used in designation and the list of chemicals
subject to regulation under each section.


SECTION 4 REGULATIONS

     Section 4 of TSCA provides EPA with the regulatory authority to require
health and environmental testing of a chemical substance or mixture.  TSCA
specifies that testing may only be required if insufficient data exist to
"reasonably" determine or predict the effects of a chemical on health or the
environment, and if testing is necessary to develop the needed data.  There
are two situations under which EPA may require testing:

     (1)  If "the manufacture, distribution in commerce, processing,
          use, or disposal of a chemical substance or mixture, or
          . .  .  any combination of such activities, mav present an
          unreasonable risk of injury to health or the environment"
          (Section 4(a)(l)(A)), or

     (2)  "A chemical substance or mixture is or will be produced in
          substantial quantities, and (I) it enters or may reasonably
          be anticipated to enter the environment in substantial
          quantities or (II) there is or may be significant or sub-
          stantial human exposure to such substance or mixture"
          (Section 4(a)(l)(B)).l2J

     TSCA provides a number of mechanisms whereby testing rules may be promul-
gated, including EPA's own initiative, or a favorable EPA response to a citi-
zens' petition for testing.  The most important mechanism at present is the
TSCA-mandated interagency advisory committee.  Section 4(e) establishes this
committee, consisting of representatives of eight agencies, who must develop
and submit to EPA a list of chemicals recommended for consideration by the
Agency.  The first priority list was to be published within nine months of the
effective date of TSCA and was required to be revised  (if considered
necessary) every six months thereafter.

     Although EPA reserves the right to consider other chemicals not appearing
on the priority list for testing, the Agency has to give priority consideration
      12JToxic  Substances Control Act, PL 94-469, Oct.  11,  1976, Section  4(a)
 (Emphasis  added).  See detailed discussion above, pp.  1-1  through  1-21.

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                                   1-23

to the committee's list.  Within 12 months of a chemical  first being included
on the priority list (and targeted by the committee for regulatory action
within 12 months), EPA must either initiate a ralemaking  proceeding for
testing the chemical or publish its reason for not doing  so.

     By January 1, 1981,  the committee (known as the TSCA  Intaragancy Tasting
Committee (ITC)) had included 42 entries on the priority  list.   (TSCA specifies
that no more than 50 entries are permitted at any one time.)  Because the  ITC
also included classes of chemicals as single entries on the. list, the actual
number of chemicals recommended to EPA expands to over a  thousand.  Cf these,
EPA has taken action15-1 on one class of chemicals (chlorinated benzenes) and
two chemical substances (chloromethane and aery1amide).   Exhibit  1-2 shows the
list of chemicals recommended by the ITC and the dates designated for
regulatory action.


Criteria for Designation

     In order to discuss the rationale behind the designation of  chemicals for
testing under TSCA Section 4, it is useful to examine the work of the Inter-
agency Testing Committee which recommends the chemicals to  be considered by
EPA, before looking at the decisions taken by EPA on those  chemicals.

ITC Criteria:  TSCA instructs the ITC to consider "all relevant  f actors''lij
when making recommendations on chemicals, including:

        (i)  the quantities in which the substance or mixture is  or
             will be manufactured,

       (ii)  the quantities in which the substance or mixture anters
             or will enter the environment,

      (iii)  the number of individuals who are or will be exposed to
             the substance or mixture in their places of  employment
             and the duration of such exposure,

       (iv)  the extent to which human beings are or will be exposed
             to the substance or mixture,

        (v)  the extent to which the substance or mixture is closely
             related to a chemical substance or mixture which is
             known to present an unreasonable risk of injury to
             health or the environment.
     13J45 rS. 48524, July 18, 1980; 45 TR i3663, July 21,  1980.

     1UJTSCA, Section 4(e)(l)(A).

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                                   1-24

                                 EXHIBIT 1-2

                       TSCA Section 4(e) Priority List
antry:                                        _
Acetonitrile
Acrylanide
Alkytin Compounds
Alkyl epoxides
Alkyl phthalates
Aniline and bromo, chloro, and/or nitroanilines
Antimony (metal)
Antimony sulfide
Antimony tricxide
Aryl phosphates
Benzidine-based Dyes
Benzyl butyl pthalate
Butyl glycotyl butyl pthalate
Chlorinated benzenes, mono-and di-
Chlorinated benzenes, tri-, tetra-and penta-
Chlorinated naphthalenes
Chlorinated paraffins
Cresols
o-Dianisidine-based Dyes
Dichloromethane
1,2-Dichloropropane
Cyclohexanone
Fluroalkenes
Glycidol and its derivatives
Kalogenated alkyl epoxides
Hexachloro-1, 3-butadiene
Kexachlorocyclopentadiene
Hydroquinone
Isophorone
Mesityl oxide
4,4'-Methylenedianiline
Methyl ethyl ketone
Methyl isobutyl ketone
Nitrobenzene
c-Tolidine-based Dyes
Phenylenediamines
Polychlorinated terphenyls
Pyridine
Quinone
Toluene
1,1,1-Trichloroethane
Xvlenes
Designated for EPA Action bv:
        April 1980
        April 1979
        October 1981
        October 1978
        October 1978
        April 1980
        April 1980
        April 1980
        April 1980
        April 1979
        November 1980
        October 1981
        October 1981
        October 1978
        October 1979
        April 1979
        October 1978
        October 1978
        November 1980
        April 1979
        October 1979
        April 1980
        October 1981
        October 1979
        April 1979
        October 1978
        April 1980
        November 1980
        April 1980
        April 1980
        April 1980
        April 1980
        April 1980
        October 1978
        November 1980
        April 1981
        April 1979
        April 1979
        November 1980
        October 1978
        April 1979
        October 1978
Source:  Seventh Report of the Interagency Testing Committee to the Adminis-
         trator, Environmental Protection Agency, 45 FR 78432
         (November 25, 1980).

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                                   1-25

       (vi)    the existence of data concerning the effects of
               the substance or mix-cure on health or the
               environment,

      (vii)    the extent to which testing of the substance or
               mixture may result in the development of data
               upon which the effects of the substance or
               mixture on health or the environment can
               reasonably be determined or predicted, and

     (viii)    the reasonably foreseeable availability of
               facilities and personnel for performing testing
               on the substance or mixture.

     TSCA also instructs the committee to give priority attention to chemicals
which are known or suspected of causing or contributing to cancer, gene
mutations, or birch defects.

     In each of its seven reports through 19801!J  the ITC has presented its
reasons for recommending a chemical or class of chemicals for testing.  The
committee considered each chemical for six types of tasting:  carcinogenicity,
mutagenicity, teratogenicity, other chronic effects, environmental effacts,
and epidemiology.  Reasons for recommendaticns typically involve a high
production volume for the chemical, a high release rate into the environment,
widespread human exposure in the workplace and/or from consumer products,
biological activity or known acute toxic effects of the chemical, inconclusive
but suggestive previous test results, inability to extrapolate adequately  from
previous tests, lack of any prior testing, or structural similarity to
chemicals known or suspected to be harmful.

SPA Criteria:  EPA is instructed by TSCA that the "health and environmental
effects for which standards for the development of test data may be prescribed
include carcinogenesis, mutagenesis, teratogenesis, behavioral disorders,
cumulative or synergistic effects, and any other effect which may present  an
unreasonable risk of injury.  The characteristics of chemical substances and
mixtures for which standards may be prescribed include persistence, acute
toxicity, subacute toxicity, chronic toxicity, and any other characteristic
which may present such a risk."1'-1
     lsjThese were published as follows:
     First report:  42 FR 55026, October 12, 1977  Second report:
43 FR 166374,"April 19, 1978   Third report:  43 FR 50630, October 30, 1973.
Fourth Report: 44 F5 31386, June 1,1979.  Fifth Report:  44 FR 70664,
December 7,1979.  Sixth Report:  45 FR 35397, May 23,1980.  Seventh Report:
45 FR 78432, November 25, 1980.

     l'-1 Sect ion 4(b)(2)(A) continues:  "The methodologies that aay be pre-
scribed in such standards include epidemiologic studies, serial or hierarchical
     j in vitro tests, and whole animal tests.  ..."

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      o.f this report, EPA has  not  issued any final standards  for testing
     ::;ec,'-,:.on 4.  However, in  its  first proposed rule17-'  requiring testing
     S:c.ion «, EPA outlined  its  approach to determining the  need for a
    ••<" Trie.  EPA differentiates  between the evidence necessary to make a
    ..;.,?ec finding (Section  4,(a}(J)(A)) and an exposure-based  finding (Section
    .  ' : 1).   The agency notes  that the former fir»dir,,g  ("may present an
    •• r.uanlt? risk") is relevant where there is a scientific basis for
    >":;-:; g potential toxicity  and  where the potsrtial for risk may be
    £i:-3nt  even when the potential for exposure seems small.   There is a ne«d
    ">r" ryposure in order to -nak.e  a Section i(aKl)(A) finding,  however, "he
     .'",- '•-hteshold is much lower than Binder Section A(a)(l)(3).   In the lattf.r
     ,'T--' ~£n require testing,  "not because of suspicions about  the chemical's
    ;-,  br"  because there say  be substantial or significant human exposure to
    ,'-•'*] whose hazards have  not  been explored.''! !-

    •'.'' stated the following 2°li£v for purposes of Section 4(a)(1)(A): 1SJ

    •:  "here is substantial evidence that exposure to a  chemical
     -v-' lead to a serious health  effect or increase  in mortality
    ,;•.-;d r.hat people may be  exposed to the chemical,  EPA  will  pre-
    ; .uie that the activities  in question (manufacturing,  processing,
    >;„•;>:,'ig,  transporting, disposing) "may present an  unreasonable
    rv-k" unless the rule is  likely to result in a significant  loss
    •;:,, society or the benefits of  the substance    In the latter
    instances, if EPA's analysis  shows that the costs of testing
    a^y cause manufacturers or processors to cease or severely
    restrict their commercial  activities, EPA will weigh this
    -oc.ential adverse impact  against the benefits  of testing  before
      •csuming that the chemical may present art unreasonable risk.
    -".••cher this balancing  is  necessary will depend  upon the
    c-.-o-aomic impact of each rule.

     :. vhis same proposed rule, EPA outlined the steos it takes as general
    .  a,i making a finding of  insufficiency of data.  Most of  the agency's
    ,r. ?.re  directed at a detailed and critical literature review.  Because
    V1. ";isted all recommended chemicals as being of  equal priority, EPA is
       "g uith its review and rulemaking more or less in chronological order
    .;• :\s~e  of recotameridation  by the ITC.

    ", : is worth noting that EPA's  proposed rules differ  from  the ITC ' s recom-
    •r...JTIS in a number of ways.  This is shown in Exhibit 1-3  which presents
     ',;r,'t>.5sed test rules for  seven chemicals and final dec it-:'on on a;j e* rhth.
    •  •• Vhloromethane  cind  Chlor:'n-atp>-J %&nzeii<-f ",'":;,±i>c.~:?,d ",,£&-,  xule,  45> .-'H
'l  -'-,  J" y IS,  1980.   At  this  tiae,  FFA rlso insu-/3  "he  dfcisicn no*- vo order
-,:-.::_,,- ..-.,-r acrylatr.lde,  ariot.:; u  lubct.ar.ce ;•,, vhr-.

    '• '- >'veashle to  Propouftd R".:," ,  r,

    - ••  .bid. p. ACS2?

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                                   1-27

and compares the tests and reasons for testing with the ITC recommendations.
The difference between the ITC recommendations and EPA's rulemakir.g  is
expected because the two organizations are working under different ground
rules.  Thus, the ITC may recommend a chemical for testing even if it is aware
of test s-Tidies already going on.  EPA, on the other hand, may decide not to
require testing because of tests that have been initiated.  (This is the case
for acrylamide, where EPA decided not to require cncogenicity tasting in par-:
because Dow Chemical Company planned to test the substance.)

     Secondly, EPA may defer test requirements recommended by the ITC if appro-
priate test standards or complete test sequences have not been developed.   (For
example, EPA deferred mutagenicity testing for chloromethane in its  proposed
rules.)

     Third, EPA may come to different: conclusions from its intensive review of
the literature than the recommendations reached by the ITC.  This is expectad
by both parties because (a) the ITC works within an even tighter deadline than
the Agency and may not have available all the data eventually gathered by EPA;
and (b) EPA must consider the appropriate allocation of its own regulatory
activities and of the cost burden of testing chemicals.  For example, EPA
decided that acrylamide should not be tested because enough is known about  its
neurotcxicity to move towards adopting regulatory controls.  Because controls
adopted for the chemical's neurotoxicity would likely protect against its other
effects, EPA decided not to require a complete assessment of these nonneuro-
logical effects, stating that the Agency's "rulemaking activities should be
devoted to more pressing testing needs concerning chemicals about which much
less is known."laj

     Fourth, the issue of using categories of chemicals is dealt with differ-
ently by EPA and the ITC.  Under Section 26(c) of TSCA, EPA is permitted to use
categories of chemicals in rulemaking in the same manner as individual chemi-
cals (as long as the classification is suitable for purposes of the Act).21-
As noted, the ITC made use of this provision in designating a large number of
chemical categories for inclusion on the priority list.  EPA, however, must
not only review all available data on each member of a recommended category,
but decide whether and how to sample the category for testing purposes to meet
both validity requirements and the needs of the reimbursement system.

     In the case of chlorinated benzenes, EPA selected six members of the
category for testing out of a total of 11.  (Hexachlorobenzene is a member of
the chlorinated benzenes family but was not included in the ITC'5 recommenda-
tions.  It is being regulated by EPA under SCRA.)  EPA chose the sample in
order to "represent all levels of chlorination, the full range of physio-
     2a-E?A Response to the Interagency Testing Committee and Decision Not
to Propose Further Testing of Acrylamide, k5 FH 43663, July 21, 1S80.

     2lJTSCA describes a category as "a group of chemical substances the
members of which are similar in molecular structure, in physical, chemical,
biological properties, in use, or in mode of entrance into the human body o:
into the environment . .  ."(Section 25(c)(2)(A)).

-------
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-------
                                   1-29

chemical properties,  and compounds having the highest commercial production
among the chlorinated benzenes."  The Agency was able to choose this sample,
in part, because "the structural relationships among the chlorinated benzenes
lead to the expectation of regular progressive changes in properties going
through the series."   EPA found "a reasonable presumption that the biological
behavior of these 11  chemicals will present a coherent picture of toxicity and
that biological data  on a well-chosen sample of category members can be used
to characterize the biological behavior of the untested members. "11-

     Finally, SPA aust write test rules that are well-specified and justifiable
as regulations.  Thus, for example, EPA agreed with the ITC that an apidemio-
logical study of chloromethane would be useful, but was unable to propose
requiring one because of the lack of information needed in order to identify a
suitable cohort.

     In the preamble  to its first proposed test rules, EPA acknowledges this
uncertainty and requests comments on virtually every aspect of the
rulemaking.  On the technical side,23-1  for example, EPA raised questions
such as :

          •    "Should EPA require behavioral teratogenicity
               testing of chloromethane?  If so, what test
               methodologies for assessing behavioral teratogenic
               endpoints are appropriate for chloromethane?"

          •    "Will  oral subchronic tests on the chlorinated
               benzenes using only the rat (i.e. only one species)
               be sufficient to characterize the risk of
               subchronic/ chronic effects?"

     Some of the general issues raised in the preamble are worth recording
here in some detail,  because they go to the heart of the1 decision-making
process under Section 4.  For example,  comments were solicited on the
following questions:**-1

          •    "How much exposure information is pertinent to the
               unreasonable risk finding under Section
               ("EPA has taken the position that as long as it can
               b« shown chat some exposure to a substance exists or
               that there is a potential for such exposure, and
               there is the potential for serious health effects, a
               Section 4(a) (1) (A) (i) finding can be made.")
    "••Preamble to Proposed Test Rules, 45 FR 43554.

    I1J?p. 48558-43561.

    '"-pp. 43561-48563.

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                          1-30

•    "Is the Agency's approach to deciding what substance
     to test the most appropriate one?"

     ("EPA considered a totally ad hoc approach for
     determining what to test versus a case-by-case
     approach within a general policy stating
     considerations for selecting a test substance
     considered for purposes of Section 4 of TSCA.  EPA
     decided upon the latter course.")

•  "What role should information about exposure play in
     constructing a structure-based category meeting the
     finding under Section 4(a)(1)(A)(i) of TSCA?"

     (SPA considered whether chemicals in a category which
     are not commercially produced and which result in
     little or no exposure should be included in the
     category for testing purposes.  EPA believes that it
     would be appropriate to consider a chemical as a
     member or the category if (a) it is commercially
     produced or a, by-product of commercial production or
     (b) if it is a reasonable substitute for a substance
     that is commercially produced.)

•    "With respect to testing to be required for
     structure-based categories, should EPA utilise a
     sampling approach where the sampled members are
     considered to be representative of all members of the
     cateogry, or require full testing of all members?  If
     the former approach is chosen, what approach should
     EPA use in determining what is an appropriate subset
     to sample?"

Four alternative sampling approaches were considered by EPA
as follows:

A.   No sampling--test every category member.  EPA
     considers this option infeasible.

B.   Sample only when there is strong evidence that one or
     more substances can, in fact, represent the category.
     SPA believes this option would almost eliminate the
     use of categories because it requires information
     unavailable at the time of rulemaking.

C.   Test the highest or most critical exposure chemicals.
     This option was rejected because the chemicals chosen
     would not necessarily be representative.of the
     category.

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                                   1-31

         D.   Sample on the basis of spanning the structural spec-
              trum of a category taking  into account exposure  and
              production information.  This option was  chosen  in -he
              proposed rules because it  permits  extrapolation  to
              other category members.

    It is doubtless the case that many of these  issues  were raised  in the
first proposed testing rules precisely because this was the first opportunity
for public comment on an actual Section  4 rulemaking.   Nevertheless EPA's pol-
icy on some of these issues will likely  continue to be  uncertain and subject
to change in the near future.

Naming Conventions

    Chemicals subject to regulation under Section 4 (and  those recommended by
the ITC) are designated by their generic names and CAS  numbers.  Categories
are usually defined by their molecular structures, and  member  chemicals  are
specified.

    For example, the definition of the chlorinated benzenes category is  "the
group of substituted benzene compounds in which  one to  five hydrogen atoms of
benzene are replaced by chlorine atoms,  with no  substituents present other
than chlorine and hydrogen."Z5J  Category members are listed as:

      (i) mononochlorobenzene  (chlorobenzene, CAS No. 108-90-7),

     (ii) 1,2-dichlorobenzene  (ortho-dichlorobenzene, CAS No.
          95-50-1), etc.

Test Methods

    Because Section 4 regulations require industry to test their chemicals,
the issue of test methods is of primary  importance.  As discussed above, in
many cases EPA has been unable to propose test rules because of the
unavailability of test standards (such as for environmental effects), the lack
of an appropriate test sequence (such as for mutagenicity testing), or an
inability to specify an element of the test method (such  as the identity of
the cohort in an epidemiological study).

    EPA has felt a need to specify in its rules  precisely which testing pro-
tocols are to be followed in order for test results to  be considered valid
under Section 4.  In its proposed health effects test standards under TSCA
(44 F3 27334 and 44 FR 44054), the Agency described the proper conduct of each
test, including the frequency, duration, and method of  dosing  (e.g., 1-4 hours
single inhalation dose); the required test species, sex,  age,  and numbers of
animals and groups; treatments and observations, and procedures to be followed
(e.g. histopathology, hematology).  The  Agency typically  cites references to
protocols that have been developed and used in the toxicology  literature.
    tsj40 CFR 773, Subpart B  (proposed) (45 TB. 43564).

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                                   1-32

     In its first set of proposed rules, EPA specified which tests were to be
performed on which chemicals.   In certain cases SPA amended the test standards
proposed earlier, or specified in more detail some of the test methods.  ?cr
example, testing of chlorinated benzenes for oncogenicity must be done on a
particular (Sprague-Dawley) strain of rats.

Mixtures

     TSCA explicitly allows for the testing of mixtures under Section 4(a)(2),
if the health or environmental effects of a chemical mixture "may not be
reasonably and more efficiently determined or predicted by resting the
chemical substances which comprise the mixture."  To date, the IT" has not
recommended any mixtures for testing.

Section 4(f)

     This section of TSCA describes the actions required by EPA upon receipt
of any test data submitted under the Act or any other information, "which
indicates to the Administrator that there may be a reasonable basis to
conclude that a chemical substance or mixture presents or will present a sig-
nificant risk of serious or widespread harm to human beings from cancer, gene
mutations, or birth defects."   Within 180 days of receipt of such informs-ion,
(and a possible extension of an additional 90 days) EPA is required 10 "initi-
ate appropriate action under Section 5, 6, or 7 [of TSCA] to prevent or reduce
to a sufficient extent such risk or publish in the Federal Register a finding
that such risk is not unreasonable."

     Section 4(f) went into effect on January 1, 1979.  As of January 1, 1981,
EPA has not determined its final policy on the section.


SECTION 5 REGULATIONS

     Section 5 of the Toxic Substances Control Act (TSCA) provides EPA with
considerable authority to prevent the manufacture of chemicals that may present
an unreasonable risk of injury to health or the environment.  This authority
is realized, first, by the requirement of premanufacture notification, whereby
EPA must be notified before the manufacture of a new chemical substance or of
a chemical substance for a significant new use.

     Once EPA has received premanufacture notification, the Agency may ragulata
the chemical under Section 5(e) of TSCA if further information is required to
determine the risk presented by the chemical.  If EPA finds that the chemi-
cal presents an unreasonable risk, the Agency may regulate the chemical under
Section 5(f).

     The following sections review each of these components of the Section 3
regulatory program.

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                                    1-33

 Prenanufacture Notification26-1

      Z?A proposed regulations on premanufacture notification requirements and
•review procedures in January 1979,27-1  and reproposed revised guidelines in
 October 1979. 2IJ   Meanwhile, however,  the requirement of premanufact-are
 notification i& in force,  and the chemical industry has been using the forms
 and guidelines supplied by EPA in the reproposed rules.

      Although it is not clear exactly what will be required in the final noti-
 fication rulesj it is likely that the following information will be mandatory
 for each new chemical:

      a.   A description of the new chemical substance:
           chemical identity, molecular structure, Chemical
           Abstracts Service (CAS) registry number, common or
           trade name;

     ' b.   The estimated total amount to be manufactured and
           processed;

      c.   The proposed categories of use;

      d.   The estimated amount to be manufactured and processed
           for each category of use;

      e.   The manner and methods of distribution in commerce
           (including transportation) and disposal;

      f.   Descriptions of exposure levels of humans and
           ecological populations to the chemical substance;

      g.   All known test data on the health effects, ecological
           effects, physical and chemical properties,
           environmental fate characteristics, and exposure of
           the substance to humans or the environment.

      Optional information to be submitted may include descriptions of engi-
 neering safeguards and controls; industrial hygiene considerations and other
 measures to be used to limit exposure; explanations of risk to health and the
 environment resulting from the manufacture, processing, distribution in com-
 merce, use or disposal of the chemical substance, including explanations of
 test programs used to assess risk; etc.
      2SJBecause the notification requirements encompass both manufacture and
 imports of new chemicals, and in some cases, processing of chemicals, EPA
 sometimes uses the broader term "Section 5 notification".

      27J4A FR 2242, January 10, 1979.

      28-44 FR 39764, October 16, 1979.

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                                   1-34

Chemicals Subject to Notification Requirement

     As noted above, there are two types of chemicals subject to
premanufacrure notification.   The intention to manufacture new c'-^mical
substances mist be reported;  new chemicals are those which do no. appear on
EPA's inventory of chemical substances.  The inventory, required by Section
3(b) of TSCA, lists all chemicals known to be in production between January  1,
1975 and May 1, 1978; chemicals not included on the inventory are considered
"new."

     Also subject to notification requirements is the manufacture or processing
of a chemical substance for a significant new use.  EPA may determine that
the use of a chemical is a significant new use after considering the following
factors:

     (1)   the projected volume of manufacturing and processing of
          the chemical;

     (2)   the extent to which a use changes the type or form of
          exposure of human beings or the environment to the
          chemical;

     (3)   the extent to which a use increases the magnitude and
          duration of exposure of humans or the environment to the
          chemical; and

     (A)   the reasonably anticipated manner and methods of
          manufacturing, processing, distribution in commerce, and
          disposal of a chemical substance.ZSJ

     The notification requirement for significant new uses is therefore quali-
tatively different from the requirement for new chemicals.  Although TSCA does
not mention unreasonable risk with regard to making a determination of signif-
icant new use, it is likely that significant new use rules will be developed
only for chemicals for which there is some concern about expansion or shifts-
in uses.

     Because EPA has not yet issued any "significant new use rules" (SNURs),
it is difficult to say how the Agency intends to use this authority.  It is
also difficult to classify SNURs as "designation" or "regulation" actions.
The only regulation that is inherent in a SNUR is the premanufacture
notification requirement.  For example, EPA might issue a SNUR for any
increased production of a particular chemical above a certain volume.  If the
manufacturer's notification shows that exposure will not increase appreciably,
EPA nay decide that no further regulatory actions are needed.
     2SJTSCA, Section 5(a)(2).

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                                   1-35

    Nevertheless, by virtue of the fact that the determination or significant
new use will likely rest on concerns about the health effects of the chemical,
the SNTJR may be considered a preliminary form of designation.'°J
The first SNUR was proposed in November, 1980, for N-methanesulfonyl-p-
toluenesulfonaniide.3 lj

Regulation Pending Development of Information--Section 5(e)

    Based on the information submitted in the premanufact-are notification,  if
EPA finds that there is not enough information to make a "reasoned evaluation
of the health and environmental effects" of the chemical, and the substance
may present an "unreasonable risk" to health and the environment, or will be
produced in substantial quantities, or there may be significant or substantial
exposure, EPA can issue a proposed order to prohibit or limit the manufacture,
processing or distribution of the substance.  This is authorized by Section
5(e) of TSCA.

    The order (or, in some cases, court injunction) is intended to remain in
effect until the manufacturer submits information or test data to EPA that  are
sufficient to evaluate the health and environmental effects of the chemical.

    The findings under Section 5(e) are similar in some respects to the  find-
ings EPA makes in issuing testing regulations under Section 4 ("may present an
unreasonable risk", insufficient information on chemical effects, "substantial
quantities or significant or substantial human exposure").  However, under
Section 4, £?A must also make a finding that testing the chemical is required
to provide the data needed.  Under Section 5(e), EPA has no authority to
require testing of the chemical in question.

    Of the several hundred premanufacture notifications E-PA has received since
the inception of the Section 5 program in July 1979, as of January 1, 1981,
EPA has taken Section 5(e) action in three instances.  In each case, the
manufacturer withdrew the premanufacture notification upon being informed of
the Section 5(e) action.  A brief look at the substances involved in these
cases is instructive.
    30JThis is supported by Section 5(g) of TSCA which requires EPA to pub-
lish a statement of reaons if the Agency does not initiate action  (under
Sections 5, 6, or 7) on a significant new use chemical.

       45 FR 78970 (November 26, 1980).

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                                   1-36

    Six AlkyI Phthaiate Plasticizers.  In May 1980, EPA notified the
manufacturer of six alkyl phthaiate plasticizers32J to delay production
until the results of further testing were submitted.  The basis of this action
was the potential carcinogenicity of the plasticizers and their toxicity to
aquatic organisms.  EPA was alerted to this by data on a related phthaiate
which has been shown to be a liver carcinogen in animals (di(2
ethylhexyDphthalate).   In addition, EPA was concerned about the large
production volume of the chemicals.  The Agency estimated that 3GQ-4QO workers
might be exposed during production of the plasticizers, and 1,000-10,000 night
be exposed during the fabrication of products.  The manufacturer, whose name
was held confidential,  had not submitted any test data with the notification,
and withdrew the chemical because the tests were too expensive (about S4
million by EPA's estimates) and because the company was afraid that further
publicity would reveal its identity.

    Lubricant Additive.  This product is composed of a group of substituted
phenol reaction products with C22-30 alkenes; both its name and the nane of
the manufacturer were claimed confidential.  The product is similar to another
chemical which is a known skin irritant.  On the basis of this information and
its estimate that the product might come in contact with over a million people
after distribution, EPA requested that the manufacturer carry out skin
sensitization tests and report the information.  The proposed tests wera
estimated to take about two months to perform and cost between 36,000 and
$14,000.  The manufacturer withdraw the chemical from premanufacture
review.33J
    32-The six substances were reported as:

    (1)  Polymer of phthalic anhydride, ethylene glycol, heptanol, and
         2-ethylhexanol;

    (2)  Polymer of phthalic anhydride, 1,2-propylene glycol, 1,4-butanedicl,
         1-octanoi, and 1-decanol;

    (3)  Polymer of phthalic anhydride, ethylene glycol, heptanol, 1-decanol,
         and 1-octanol;

    (4)  Polymer of phthalic anhydride, 1,2-propylene glycol, 1,4-butanediol,
         and 2-ethylhexanol;

    (5)  Polymer of phthalic anhydride, 1,3-butylene glycol, 1-octanol, and
         1-decanol;

    (6)  Polymer of phthalic anhydride, 1,3-butylene glycol, 2-eth7lhexanol.

    (Chemical Regulation Reporter. May 2,  1980, p. 117.)

    33J Chemical Regulation Reporter, October 3,  1980, p. 841.

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                                   1-37

    Phthalate Ester Plasticizer.  This compound was proposed for production
by Union Camp Corporation and withdrawn from the review process on October 7,
1980 before EPA issued a Section 5(e) notice.  EPA had indicated to the
company that additional tests for carcinogenicity and possibly nutagenicity
would be required.  Similar to the earlier plasticizers subject to Section
5(e), this product was an analogue to substances with potential
carcinogenicity and toxicity.Jfcj

    It is important to recognize that EPA's experience with Section 5(e), as
with all aspects of the premanufacture program, is quite recent.  EPA had
originally intended to develop criteria that would indicate when a chemical
should be subjected to detailed review, but the Agency has been unable to com-
plete this task.  As the Agency gains more experience with the Section 5
programs and develops general criteria for rulemaking, the direction of EPA's
regulations will become clearer.

    One example of how Section 5 rulemaking could change is shown by EPA's
recent suspension of the review process for two chemicals while the manufac-
turer and agency negotiated tests and controls for the new chemicals.  Volun-
tary suspension of the review process and subsequent negotiation would be akin
to a 4(e) consent action, and could present a useful alternative for both EPA
and industry to the costly or protracted Section 5(e) rulemaking.3SJ

    Finally, a major concern in EPA's review of the premanufacture notifica-
tions has been the lack of test data submitted for new chemicals.  Although
EPA cannot require testing under Section 5, the Agency hopes to induce compan-
ies to test their chemicals by issuing guidelines in 1981 for tests that
should accompany notifications.  The guidelines will be based on the minimum
premarketing set of data developed by the Organization for Economic
Cooperation and Development.

Protection Against Unreasonable Risks--Section 5(f)

    In addition to Section 5(e) regulation of new chemicals pending the devel-
opment of information, EPA can regulate new chemicals under Section 5(f) of
TSCA.  If EPA determines that the manufacture, processing, distribution in com-
merce, use or disposal of the chemical will present an unreasonable risk
before the Agency can take action under Section 6(a) of TSCA, EPA can prohibit
or limit the manufacture or processing of the chemical.  EPA's regulatory
powers under Section 5(f) are identical to its authority under Section 6(a) of
TSCA.  For example, the Agency can require warning labels, public
notification, limitations or prohibitions on the amount of a chemical
produced, on particular uses, or on the concentration of a chemical in a
    3*JThis plasticizer is a polyester of adipic and phthalic anhydride,
prcpanediol-1,2 and alkylene diol and octyl alcottol.,   (Chemical Regulation
Reporter, October 10, 1980, p. 881.)

    35J Chemical Regulation Reporter, October  10,  1980, p. 882.

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                                   1-33

particular use.  However, the Section 5(f) provisions allow EPA to regulate a
new chemical more quickly (by means of an injunction or an immediately
effective proposed rule) than would be possible under Section 6.

    EPA has not yet taken any regulatory actions under Section 5(f) nor
published a policy statement on its intended interpretation of the law.

SECTION 6 REGULATIONS

    Section 6(a) of T3CA gives ZPA the authority to act when it finds that
there is "a reasonable basis to conclude that the manufacture, processing,
distribution in commerce, use or disposal of a chemical substance or mixture
presents or will present an unreasonable risk of injury to health or the
environment."

    EPA is given a wide range of regulatory controls to use under Section
6(a), including labeling requirements, requirements that manufacturers notify
the public of risk, and limitations and prohibitions on particular usas of a
chemical or on the concentration of a chemical in a particular use.  EPA's
regulatory authority extends to all aspects of chemical control:  manufacture,
processing, distribution in commerce, use, and disposal, as well as qualify
control procedures in individual manufacturing and processing plants
(Section'6(b)).

    In making a Section 6 rule, EPA must use the "least burdensome'" require-
ments5 Sj that will give adequate protection against the risk.  In promulgat-
ing a rule, EPA is required to publish a statement that addresses the effect
of the chemical substance on health and the magnitude of human exposure; the
effect on the environment and the magnitude of environmental exposure; the
benefits of the substance and the availability of substitutes; and the eco-
nomic consequences of the rule, (including effects on the national economy,
small business, technological innovation, the environment, and public health).

    As of January 1, 1981, EPA has completed only two rules under Section 6
and is in the process of developing regulations in two other areas.  The
Agency has not yet published any regulations or policies that present general
criteria for determining "unreasonable risk."

    The remainder of this paper discusses EPA's actions on three Section 6
areas:  ?C3s, chlorofluorocarbons, and asbestos.
    3S-Section 6(a).  The term "least burdensome" is not defined in TSCA.
However, guidance on the meaning of the tera is provided by the list of  fac-
tors to be considered by EPA when promulgating a Section 6 rule, and by
Section 2(b)(3) of TSCA, which states as general policy, that "authority over
chemical substances and mixtures should be exercised in such a manner as not
to impede unduly or create unnecessary economic barriers to technological
innovation.  ..."

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                                   1-39

Polyshloriaated Biphenyls  (PCBs)

    At the time that TSCA was enacted, the problem of PC3 contamination was
especially well-publicized.  Control of PCBs was written into the Act.    EPA
was directed to prescribe methods for PCS disposal and to require labeling and
instructions on PCS use and handling.  Regulations for disposal and marking of
PCBs were published in February, 1978.3^  These were integrated into the
final rule on the ban of PCBs in May 1979. "J  This rule bans the production
of PCS except for specific exemptions which must be approved by EPA.  Because
the PCB regulations were specifically mandated by Section 6(e) of TSCA, EPA
did not have to use the more general authority of Section 6(a), and therefore
could pass lightly over the issue of defining unreasonable risk for these
regulations.3SJ

    The final regulations defined all electrical capacitors, electromagnets,
and non-railroad transformers as totally enclosed uses, thus automatically
exempting them from regulation under Section 6(e).  The final regulations also
authorized eleven non-totally enclosed uses to continue, based on a
consideration of the health and environmental effects of PCBs, t-he expected
exposure, the availability of substitutes for the PCBs, and the economic
impact of restricting those uses.  The final regulations were reviewed by the
U.S. Court of Appeals for the District of Columbia and were, in part, upheld
and in part remanded for further proceedings.*"-1

    The reviewing Court upheld EPA's choice of factors for determining whether
non-totally enclosed uses of PCBs will present an unreasonable risk of injury
to health or the environment.  The factors used are those listed in Section
6(c)(l) which governs the promulgation of rules issued under Section 6(a),
These factors are listed above.  The Court also approved of EPA's application
of these factors.*IJ

    On the other hand, the Court did not uphold EPA's decision to list several
uses of PCBs as "totally enclosed" and therefore exempt from regulation under
    37J43 FR 7150, February 17, 1978 (Technical Amendments:  43 FR 33918,
Aug. 2, 1978).

    3tJ4A FR 31514, May 31, 1979, 40 CFR Part 761.

    3SJEPA did make a finding under Section 12(a)(2) of TSCA that the manu-
facture, processing, and distribution of PCBs for export presents an unreason-
able risk of injury to health within the United States.  The finding was based
on "the we11-documented human health and environmental hazard of PCB exposure;"
the high probability of human and environmental exposure to PCBs; and the evi-
dence that contamination of the environment by PCBs is spread far beyond the
areas where they are used.  (40 CFR 761.30)

    *8J EDF v. EPA. 15 ERC 1081 (1980).

    "1J Ibid., at pp.  1088, 1090.

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                                   1-40

Section 6(a).  The statute defines that expression to mean a use which "will
ensure that any exposure of human beings or the environment .  .  .  will be
insignificant."  The Court held that the record was insufficient to support
£?A's findings and classifications.k2J

    As part of the regulatory scheme for ?C3s under Section 6(e),  EPA limited
application of the Disposal and Ban Regulations to materials containing
concentrations of at least fifty (50) ppm of PCBs, with one exception (i.e.,
certain uses of waste oil contaminated with any detectable amount of ?C3s).
The reasons for using a regulatory cutoff included exclusion of ambient
sources of ?C3s from regulation, exclusion of PCBs created inadvertently
during the production process, administrative necessity, and the de minimis
principle.  The. reviewing Court held that there was "no substantial evidence
in the record to support" a regulatory cutoff of 50 ppm, or any other level,
and noted that EPA did not explain why the regulation could not be designed
expressly to exclude ambient sources without relying on a regulatory cutoff.
The Court emphasized that the authorization and exemption provisions of
subsections 6(e)(2)(3) and 6(e)(3)(B) were intended by Congress as means to
better tailor PCS control without resorting to a regulatory cutoff.  The Court
was further troubled that EPA had not determined the amount of non-ambient
?C3s excluded from regulation by the 50 pptn or other possible regulatory
cutoffs.  Additionally, the Court characterized EPA's approach as
circumventing the authorization and exemptions provisions of 6(e)  and pointed
out that EPA had made no finding that the cutoff would involve no unreasonable
risk to health or the environment.  The Court concluded that EPA needed to
conduct further proceedings to justify a regulatory cutoff.*3-1

    A challenge to EPA's PCB regulations arose over the definition of PCBs.
The Dow Chemical Company was charged by EPA on May 13, 1980, with violating
the PCB regulations by manufacturing and shipping a heat•transfer fluid
containing monochlorinated biphenyls (MCBs).  Dow fought the charge on the
basis that MCBs differ from PCBs in being less hazardous, and that MCBs are
not covered by the PCB regulations.   Dow's challenge was denied on September
22, 1980 by EPA's Administrative Law Judge.**J

Fully Halogenated Chlorofluoroalkanes (CFCs)

    These products, commonly called chlorofluorocarbons, or CFCs,  are known to
react with ozone.  It is believed by many scientists that continued use of
CFCs will lead to a decrease in the stratospheric ozone layer which offers
protection from ultraviolet rays.  EPA considered the possibility of increased
skin cancer and decreased crop yield to present an unreasonable risk and
    "*J Ibid., at p. 1097.

    *3J Ibid., at pp. 1091, 1095 n. 47, 1093, 1095.

    *UJ Chemical Regulation Reporter, Bureau of National Affairs,
September 26, 1980, p. 317.

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                                   1-41

(along with FDA) banned the manufacture, processing and use of non-essential
aerosol products containing CFCs in March, 1978."5j

    In the proposed rules on aerosol uses of CFCs,*SJ EPA noted that "quan-
titative estimates of skin cancer are somewhat speculative," but cited one
estimate that "15,000 cases of nonmelanoma skin cancer during the next century
would be prevented in the United States alone by banning U.S. aerosol pro-
pellant uses of these compounds in 1978."  EPA estimated that the proposed
restrictions on CFCs would cost industry between $169 and S267 million
annually for the four year period following regulation, but that cons-inner
savings would range from S58 to $340 million annually.  The Agency stated the
case for regulation as follows:

         At the price of a substantial one-time, readily absorbed
    economic cost which does not deprive society of essential
    products, a large number of threatened skin cancers and
    potentially serious, albeit unknown, effects on agricultural
    resources, climate, and the biosphere that would otherwise be
    suffered by future generations, would be prevented.

    EPA more recently has been considering limitations on non-aerosol uses of
CFCs.  An advanced notice of proposed rulemaking has been published1*7-1 out-
lining a variety of regulatory alternatives, including the use of economic
incentives to cut production and to encourage switching to the less ozone-
depleting CFCs.  All CFCs would potentially be regulated by EPA (i.e. all
alkanes that contain at least one chlorine and one fluorine, including CFC-11,
CFC-12, CFC-113, CFC-114, CFC-115, and CFC-22), although the regulations would
take into account the differing ozone depletion potential of the various CFC
compounds.

    Although EPA's regulations on non-essential aerosol uses of CFCs were
promulgated under the authority of TSCA, it is not clear what authority will
be used for regulating the nonaerosol uses.  EPA stated in its advance notice
that it intends to use Section 157 of the Clean Air Act unless it finds that
it is in the public interest to use TSCA (Section 6)."*J
    *5J43 FR 11318, March 17,  1978; 40 CFR 762.

    fctJ42 FR 24544, May 13,  1977.

    fc7J45 FR 66726, October  7,  1980.

    utJEPA is required by Sections 6(c)  and 9(b) of TSCA to use other
federal laws administered by EPA to eliminate or reduce risk of injury to
health or environment before using TSCA, unless the Agency finds that use of
TSCA is in the public interest.  In using TSCA to ban the non-essential
aerosol uses of CFCs, EPA determined that the Clean Air Act Amendments of 1977
"specifically permit EPA to  promulgate rules proposed under TSCA prior to
enactment of the Amendments" (43 FR 11319).

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                                   1-42

Asbestos

    EPA has been, developing a number of regulations under Section 6 to control
human exposure to asbestos.  In 1979 EPA published two advance notices of
proposed rulemaking, covering asbestos-containing materials in school build-
ings*8-1  and commercial and industrial use of asbestos fibers."-1  In
September, 1980, EPA published proposed rules for school buildings.s IJ

    In both these advance notices, EPA cited its concerns with the health
effects of exposure to asbestos, including increased risk of lung damage
(asbestosis) and several types of cancer.  A finding of unreasonable risk
requires consideration of the adverse health effects of asbestos, the number
of people subject to exposure, the effects on the environment, the benefits of
the material, and the reasonably ascertainable economic consequences of a rule.

    SPA's first advance notice dealt with friable asbestos-containing material
(i.e. material that crumbles under hand pressure) which is common in school
buildings.  No definition of asbestos is provided, and the notice seeks
comments on what the Agency can do to ensure proper identification, of asbestos
in the absence of standard reference methods and materials.  The second
advance notice aimed at covering all commercial and industrial uses of
asbestos, including the manufacture, processing, use, and disposal of asbestos
in textiles, flooring, paints, automotive parts, etc.  No definition of
asbestos was provided although the notice did state that asbestos is a generic
name for a variety of naturally-occurring fibrous mineral silicates
(chrysotile, amosite, crocidolite, anthophyllite, tremalite, and actinolire).

    In the proposed rulemaking for schools, "Asbestos" is defined as: "(1)
Chrysotile, amosite, or crocidolite; or (2) in fibrous form, tremolite,
anthophyllite, or actinolite."  "Asbestos-containing material" means "any
material which contains more than 1. percent asbestos by weight."
    *9J44 FR 54676, September 20, 1979.

    SOJ44 73. 60061, October 17, 1979.

    !145 TR 61966, September 17, 1980.

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                    THE CLEAN WATER ACT--STATUTORY REVIEW
INTRODUCTION

    The Clean Water Act's aim is to improve and protect the Nation's water
quality.  The broadly stated purpose of the legislation is "to restore and
maintain the chemical, physical and biological integrity of the Nation's
water" (Section 101(a)).  In this context, it is the "national goal that the
discharge of pollutants into the navigable waters be eliminated by 1935"
(Section lOl(a)U)).1

    The following discussion reviews what substances are subject to regulation
under the Clean Water Act, what regulatory mechanisms are to be used in
achieving the goals set in the Act, and what criteria must be considered in
taking regulatory action.

OVERVIEW OF THE CLEAN WATER ACT

    In the statutory scheme established by the Clean Water Act, three
mechanisms are provided for achieving statutory goals:

         •   The implementation and enforcement of water quality
             standards (Section 303);

         •   The achievement of effluent limitations under which
             the discharges of pollutants are to be regulated
             (Section 301) including toxic pollutants (Section 307);
             and

         •   Provisions to control discharges of oil and hazardous
             substances (Section 311).

    The achievement of effluent limitations is the primary means by which the
water quality standards are to be achieved.  However, in understanding the
administrative structure of the Act, it is important to recognise the two
    1 E. I. du?ont da Nemours and Co. v. Train, 430 U.S. 112 (1977),
represents judicial endorsement of this formulation of the Clean Watar Act's
purpose.  The Act, formally called the Federal Water Pollution Control Act, is
codified at 33 USCA §§ 1251-1378.  The Act was substantially revised by
amendments in 1972 and 1977.

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                                   2-2
mechanisms as distinct requirements.2  Water quality standards control
overall water quality and are analogous to the ambient air standards cf the
Clean Air Act.  Effluent limitations regulate actual discharges for individual
sources into the water.

    Ur.ifora water quality standards are to be implemented in all states.
Each state is to develop, submit to the EPA for approval, and implement water
quality standards for water within the state boundaries.  These water quality
standards are to be set so as to "protect the public health and welfare,
enhance the quality of water and serve the purposes of this Act" (Section
302(c)(2)).

    The provisions dealing with effluent limitations state that "except as in
compliance with this Act, the discharge of any pollutant by any person shall
be unlawful."  (Section 301(a)).  This mandate is followed by a description of
the methods and amounts' in which pollutants can be legally discharged
under the Act.  Effluent limitations programs are organized according to both
type of pollutant and type of source.  The effluent limitation provisions fall
into the following categories:

        (1)  effluent standards for existing sources of pollution,

        (2)  effluent standards for new sources of pollution,

        (3)  effluent standards for publicly owned treatment works
             (POTWs), and

        (i)  pretreatment standards for dischargers to POTWs.
    2Althcugh conceptually separate, the practical difference between the
two may be quite limited.  One commentator notes that the two mechanisms have
been wedded judically, citing Montgomery Environmental Coalitior. v. Fri, 396
F.Supp. 260 (D.D.C. 1975), where it was held "that a water quality standard
could be treated as an 'effluent standard or limitation' under the citizen
suit provisions (Section 505) of the [Clean Water] Act."  Rogers, Handbook on
Environmental Law, p. 360 (St. Paul:  West Publishing Co., 1977).

    37he method of achieving the effluent limitations is broadly described
as "best practicable technology" (see §301(b)(l)) and "best available
technology" (see §301(b)(2)).  This terminology is to be given content by
satisfying the requirements of §304(b) which involve regulations "providing
guidelines for effluent  limitations".  These guidelines are to identify what
level of control can be  achieved in terms of amounts of constituents and
chemical, physical, and  biological characteristics of pollutants.  ..."   (See
§§30i(b)(l)(a) and (b)(2)(A).)

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                                   2-3
Within each category there may be subcategories differentiated by type
(classification) of pollutant or type of source.

    Prior to 1972, there was no special provision in the Clean Water Act
addressing toxic pollutants.  Section 307(a) now sets forth the substantive
criteria for formulating toxic effluent standards, which are not subject to
individual waiver or modification as are other standards.    EPA is required to
take certain factors into account when issuing these standards and is directed
to set these standards at levels that provide "an ample margin of safaty"--a
phrase that is the section's "polestar--its guiding principle in protecting
against incompletely understood dangers."1'  The 1977 Amendments adopted a
list of 65 groups of chemical substances for EPA to regulate and provided tvo
separate procedures for development of standards:  (1) industry-by-incustry
regulations based on technological feasibility criteria; (2) health-based
effluent standards on a pollutant-by-pollutant basis with reference to six
specific factors and an ample margin of safety.  Section 307(b) and (c)
provide statutory criteria for pratreataient standards for indirect discharges.

    Finally, Section 311 deals with the special problems of oil and hazardous
chemicals discharges.  The focus, in large part, is on accidental discharges
and incident reporting.  This third mechanism, of course,  is limited to very
specific situations while the first two mechanisms are of general
applicability.

    Each of the provisions described above (§§ 301, 303, 307, 311) employ
different statutory criteria which will be discussed as each provision is
reviewed.  In general, however, the Act is concerned with "pollution" of the
water and the constituent "pollutants".  "Pollution" is defined to mean the
"man-made or man-induced alteration of the chemical, physical, biological, and
radiological integrity of water" (Section 502(19)).  This definition is very
inclusive.  The Act defines "pollutants" as "dredged spoil, solid waste,
incinerator residue, sewage, garbage, sewage sludge, munitions, chemical
wastes, biological materials, radioactive materials, heat, wrecked or
discharged equipment, rock, sand, cellar dirt, and industrial, municipal and
agricultural waste discarded into the water" (Section 502(6)).  The Act,
therefore has broad applicability due to the wide range of activities and
substances it covers.

MECHANISMS FOR ACHIEVING THE GOALS SET 3Y THE CLEAN WATER ACT

    The following discussion analyzes the major provisions used to meet the
goals of restoring and maintaining water quality and eliminating pollutant
discharges by 1983.  The discussion is organized as follows:
      EDF v. EPA, 12 ERG 1353, 1361 (B.C. Cir. 1978).

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         •   a •description or tne provision ana now it is to be
             applied;                                          ' '

         •   the substance (s) ffor example, conventional
             pollutants) covered;

         •   the harm which the provision is supposed to
             ameliorate;

         •   the level of causality which must exist between the
             substance and the harm; and

         •   other factors (for example, cost of implementing the
             mechanism) which must or may be considered.

    The review relies principally upon the statutory language, the Act's
legislative history, and caselaw interpreting and applying the Act.  Water
quality standards are discussed first, followed by effluent limitations for
three kinds of pollutants (conventional, toxic, and non-conventional) and
Section 311 hazardous (polluting) substances conclude the review.  See Exhi
2-1.

                               STANDARDS
    The states are assigned primary responsibility to establish, implement,
and enforce water quality standards.  Water quality standards were first
developed under the Water Quality Act of 1965.  Section 303 of the Clean Water
Act continues the use of water quality standards, but such standards are no
longer the mainstay of achieving the Act's goals.  Instead, as Section 302
indicates, water quality standards are used more in the role of substitute--
when effluent limitations do not perform satisfactorily, then water quality
standards are to be used.  Section 302 (a) requires water quality based
effluent limitations to be established for a point source or group of point
sources for which BAT-based limitations are not adequate to attain and
maintain the water quality necessary to protect public water supplies,
agricultural and industrial uses, animal life, and recreational activity.
Section 302 (b) requires that notice be given and hearings be held before the
water quality-based limitations are set.  Factors to be considered in setting
these limits include the relationship between the social and economic costs
and benefits, whether that relationship is reasonable, and whether the limits
can be implemented with available technology or other alternative control
strategies.

    Water quality standards involve three elements:  water quality criteria,
designated uses, and an enforcement plan.  Water quality criteria can be
thought of as ambient water standards and may be quantitative or descriptive.
An example of a quantitative standard is:  "not less than 5 parts per million
of dissolved oxygen or more than 500 micrograms per liter of dissolved solids
or more than 200 fecal coliform per 100 milliliters . "  An example of a

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                                   2-8
descriptive standard is "surface waters must be 'free from floating debris,
scum and other floating materials attributable to municipal, industrial or
other discharges or agricultural practices in amounts sufficient to be
unsightly or deleterious.'"  Designated uses involve classifying segments cf
water and defining what uses may be made of the water in a particular class.
For example, water classified in Category A must be suitable for recreation,
and water classified in Category 3, although it may not be suitable for
recreation, must be suitable for hosting and encouraging aquatic life.
Enforcement plans typically involve directives to particular sources.

    State plans are to be submitted to the ZPA for approval.  The plans are to
be designed so as to "protect the public health and welfare, enhance the
quality of water and serve the purposes of this Act" (Section 303(c)(2)).  The
standards can vary within a given state, depending on the type of use which is
made of a given body of water.  That is, the

         water quality standard shall consist of the designated uses
         of the navigable waters involved and the water quality
         criteria for such waters based upon such uses.  Such
         standards shall be established taking into consideration
         their use and value for public water supplies, propagation
         of fish and wildlife, recreational purpses, and
         agricultural, industrial and other purposes, and also
         taking into consideration their use and value for
         navigation (Section 303(c) (2)).

    The Administrator is authorized to prepare a water quality plan for any
states which do not submit one.  Plans are to be approved if they meet the
requirements of Section 303(e)(3), the principal one being that the plan must
include "effluent limitations and schedules of compliance at least as
stringent as those required by Section 301" (which, as is discussed below, is
the principal effluent limitation provision).  Each state is also instructed
to "identify waters within its boundaries for which the effluent limitations
required by Section 301(b)(l)(A) and Section 301(b)(l)(3) are not stringent
enough to implement any water quality standard applicable1to such waters"
(Section 303(a)(1)(a)).  Special standards, authorized by Section 302
discussed above, are to be implemented to facilitate achievement of the
quality standard applicable for these waters.

    Section 304 deals in part with information that EPA is to develop
regarding water quality.  EPA is required (Section 304(a)(i)) to develop,
publish, and revise criteria for water quality.  The criteria must reflect the
"latest scientific knowledge" regarding the "kind and extent of all
identifiable effects on health and welfare" from pollutants in water
(304(a)(1)(A)), the concentration of dispersal of pollutants or the
by-products of pollutants (304(a)(1)(B)), and the effects of pollutants on
biological communities (304(a)(1)(C)).  Section 304(a)(2) requires the
development, publication, and revision of information about the factors
necessary to restore and maintain the integrity of water  (304(a)(2)(A)), the
factors

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                                   2-9
necessary to protect animal life and recreation (304(a) (2) (3)),-and
measurement and classification of water quality (304(a)(2)(C)).  In addition,
Section 304(a)(2)(D) requires identification of those pollutants that are
suitable for "maximum daily load measurement correlated with the achievement
of water quality objectives."

    The following points summarize the situation in which water quality
related effluent standards are applied:

         •   The substances.  Section 302 is applicable to any
             pollutant, including toxic pollutants.  As noted
             earlier, the definition is broad and includes many
             substances that ordinarily might not be thought of as
             pollutants.

         •   The harm.  The water quality related effluent
             limitations are to assure the attainment and
             maintenance of water quality standards.

         •   The level of causality.  Water quality related
             effluent limitations must be reasonably expected to
             contribute to the attainment or oiainenance of water
             quality standards.

         •   Factors to be considered.  The establishment of
             water quality related effluent limitations is to
             consider several factors.:  the use and value of water
             as a public water supply; the well-being of fish and
             wildlife; recreation potential; agricultural and
             industrial uses; economic and social costs and
             dislocation; and use and value for_navigation.  In
             addition, setting water quality standards requires
             consideration of the relation between social and
             economic costs and benefits, whether that relationship
             is reasonable, and what other control technology or
             strategy is available.

EFFLUENT LIMITATIONS

    Effluent limitations are defined in Section 502(11) of the Act.  That
definition indicates that effluent limitations are quantitative in nature  and
are applied to.point sources.  Effluent limitations are, therefore, more
specific than water quality standards.  An effluent limitation is:

         any restriction ... on quantities, rates, and
         concentrations of chemical, physical, biological, and other
         constituents which are discharged from point sources into
         navigable waters, the waters of the contiguous zone, or the
         ocean, including schedules cf compliance.

-------
                                   2-10
    With the exception of Section 307, rhe Act directs EPA to establish
effluent limitations and -standards on an indus t ry-by- incus t rv b as is.  Within
each industry, sources are required to meet different standarcs depending on
whetner they are an existing or a new source, and whether they discharge
directly into a body of water (a direct discharger) or into a publicly-owned
treatment work or ?07W (an indirect discharger).

    In addition to these distinctions, specific limitations and standards vary
with the type of pollutant, of which there are three classifications:

        (1)  Conventional pollutants which are those identified as
             "classical" pollutants in the original (1974) Act.
             Section 304(a)(4) of the 1977 CVA identifies this class
             as "including but not limited to pollutants classified
             as biological oxygen demanding, suspended solids,
             fecal, coliform, and pH;"

        (2)  Toxic pollutants, as defined by Section 307; and

        (3)  Non-conventional, non-toxic pollutants which are any
             substances not designated as conventional or toxic.

    The Act thus mandates that a specific level of pollution control
technology be applied for each source and pollutant combination.  Exhibit 2-2
sets out the statutory definition for each of these technology standards, and
the factors which must be taken into account in identifying specific
technologies as being a certain level.

    The review of effluent limitations is divided into three subsections:
(1) effluent standards for existing sources  (conventional, toxic, and
non-conventional), (2) effluent standards for new sources, and (3)  effluent
standards for publicly owned treatment works (POTWs), and (4) pretreatment
standards.

1.  Effluent Standards for Existing Sources

    Section 301 establishes that effluent limitations should be promulgated
for three categories of pollutants discharged from existing sources.  The
nomenclature for these three categories, which is more readily apparent  from
the regulations than the Act itself, comprises:  conventional pollutants,
toxic pollutants, and non-conventional pollutants.  Section 301, together
with Section 402, mandates establishment of  a permit system through which
discharges for the three categories are to be regulated.  This system
generally regulates discharges on an industry-by-industry basis.  The
substances and industries regulated by the three categories are discussed
below.

    Conventional Pollutants.  Section 304(a)(4) identifies conventional
pollutants as "including but not limited to  pollutants classified as

-------
                                   2-11
                                 EXHIBIT 2-2

         TECHNOLOGY REQUIRED OF SPECIFIC SOURCE AND POLLUTANT TYPES
Pollutant/Source T
I .
      Conventional Pollutants
      Existing Sources
      Toxic Pollutants
      Existing Sources
Technology

Best conventional pollutant control
technology (BCT) (Section 304(b)(-)(A)).
Factors to be considered include the
"reasonableness of the relationship
between the costs of attaining a reduction
in effluents and the effluent reduction
benefits derived, and the comparison of
the cost and level of reduction of such
pollutants from the discharge from
publicly owned treatment works to the cost
and level of reduction of such pollutants
from a class or category of industrial
sources, and shall take into account the
age of equipment and facilities involved,
the process employed, the engineering
aspects of the application of various
types of control techniques, process
changes, non-water quality environmental
impact (including energy requirements),
and such other factors as the
Administrator deems appropriate."  Section
304(b)(4)(3)

Best available technology economically
achievable (BAT) "which will result in
reasonable further progress toward the
national goal of eliminating the discharge
of all pollutants" by July 1, 1984 (for
the 65 priority pollutants) or three years
after establishment (for all other toxic
pollutants listed in 307(a)(1)).  Section
301(b)(2)  Factors relating to the
assessment of best available technology
shall take into account the age of
equipment and facilities involved, the
process employed, the engineering aspects
of the various types of control
techniques, process changes, the cost of
achieving such effluent reduction,
non-water quality environmental impact
(including energy requirements), and other
such factors as the Administrator deems

-------
                                   2-12
                           EXHIBIT 2-2 (continued)

         TECHNOLOGY REQUIRED OF SPECIFIC SOURCE AND POLLUTANT TYPES
Pollutant/Source Tvr>e
      Toxic Pollutants
      Existing Sources
      (continued)
Technology

appropriate.  Section 30A(b)(2)(3)  The
statute thus requires a consideration of
costs but does not require a balancing of
costs against effluent reduction benefits.
[See Weyerhauser v. Costle, 11 ERG 2149
(D.C. Circuit 1978)].
      New Sources
      All Pollutants
IV.   Pretreatment Standards
      (A)  Existing Sources
New Source Performance Standards (NSPS)
are to be based on the "best available
demonstrated technology."  Because new
plants have the opportunity to install the
best and most efficient production
processes and wastewater treatment
technologies, Congress directed EPA to
consider the best demonstrated process
changes, in-plant controls, and
end-of-pipe treatment technologies which
reduce pollution to the maximum extent
feasible.  Section 306(a)(l)

Pretreatment Standards for Existing
Sources  (PSES) must be achieved within
three years of promulgation.  PSES are
designed to prevent the discharge of
pollutants which pass through, inter-
fere with, or are otherwise incompatible
with the operation of POTWs.  The Clean
Water Act of 1977 requires pretreatment
for pollutants, such as heavy metals, that
limit POTW sludge management alternatives
including the beneficial use of sludges on
agricultural lands.  The legislative
history of the 1977 Act indicates that
pretreatment standards are to be
technology-based, analogous to the best
available technology for removal of toxic
pollutants.

-------
                                   2-13
                           EXHI3IT 2-2 (continued)

         TECHNOLOGY REQUIRED OF SPECIFIC SOURCS AND POLLUTANT TYPES
                         /

Pollutant/Source Tyne               Technology

IV.   Pretrearaent Standards        Section 307(c) requires Pratreataent
      (B)  New Sources              Standards for New Sources (?SNTS) which EPA
           (continued)              must promulgate at the same tine that it
                                    promulgates NSPS.   New indirect
                                    dischargers,  like new direct dischargers,
                                    have the opportunity to incorporate the
                                    best available demonstrated technologies
                                    including process changes, in-plant
                                    controls, and end-of-pipe treatment
                                    technologies, and to use plant site
                                    selection to ensure adequate treatment
                                    system installation.  PSNS are designed to
                                    prevent the discharge of pollutants which
                                    may pass through,  interfere with, or
                                    may be otherwise incompatible with the
                                    operation of POTVs.

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                                   2-14
biological oxygen demanding, suspended solids, fecal coliform, and pH."
Section 301 calls for the achievement of effluent limitations for this
category of pollutants through "application of the best conventional pollutant
control technology" (§301(b)(2)(E)).   Factors to be taken into account when
determining the best conventional technology  (3CT) are set forth in Section
304(b)(4)(3).   Tnese factors are:

         consideration of the reasonableness of the relationship
         between the costs of attaining a reduction in effluents and
         the effluent reduction benefits derived, and the comparison
         of the cost and level of reduction of such pollutants from
         the discharge from publicly owned treatment works to the
         cost and level of reduction of such pollutants from a class
         or category of industrial sources, and shall take into
         account the age of equipment and facilities involved, the
         process employed, the engineering aspects of the
         application of various types of control techniques, process
         changes, non-water quality environmental impact (including
         energy requirements) and such other factors as the
         Administrator deems appropriate.

    The following points summarize the situation in which effluent limitations
for conventional pollutants are applied.

         •   The substances involved are conventional pollutants,
             as described above.

         •   The harai to be avoided or redressed is the
             degradation of the Nation's waters and its resulting
             ill effects (both health and welfare).

         •   The level of causality is not specifically stated,
             but technically the modification of the integrity of
             water constitutes pollution and triggers the
             application of this provision.

         •   Factors to be considered in setting effluent
             limitations for conventional pollutants include some
             informal balancing between control costs and benefits
             from the effluent reduction achieved, the age of
             equipment and facilities involved, the process being
             used, and other factors deemed appropriate by EPA.

    Toxic Pollutants.  In Section 502(13) the term "toxic pollutants" is
defined to mean:

-------
                                   2-15
         chose pollutants, or combinations or pollutants, including
         disease-causing agents,  which after discharge and upon
         exposure, ingestion, inhalation or assimilation into any
         organism, either directly from the environment or
         indirectly by ingestion through food chains, will, on the
         basis of information available to the Administrator, cause
         death, disease, behavioral abnormalities, cancer, genetic
         mutations, physiological malfunctions (including
         malfunctions in reproduction) or physical deformations in
         such organisms or their offspring.

The Senate Report indicated that-the definition;

         provides a. benchmark for evaluating those pollutants which
         in certain concentrations would have a particularly adverse
         impact on humans as well as other forms of life.  It is
         necessary to evaluate the effect of all forms of such
         pollutants and consider their persistence, degradation, or
         interaction with other materials, once in the receiving
         water.

The report continued to note that

         Disease-causing agents are intended to refer to all
         pathogens, including viruses, which may produce disease
         symptoms in any organisms.  In addition, any pollutant or
         agent which lowers an organism's resistance to serious
         disease should be considered a toxic pollutant.
         [Legislative History, Vol. 2, pp. 1495-1496.]

    The 1972 amendments instructed the Administrator to list all pollutants
which EPA deemed to qualify as toxic under the above definition.  For a
variety of reasons, implementation was slow.  Environmental action groups
brought four lawsuits to compel prompt regulation of toxics.  EPA, in the
meantime, had been developing a comprehensive strategy for dealing with
toxics.  The strategy was substantially adopted in a Consent Decree issued in
National Resources Defense Council et al. v. Train. 411 F.Supp. 864.  Under
the decree, EPA was to regulate, under the toxic pollutant provision, 65
families of pollutants by 21 major sources.  The 1977 Amendments essentially
wrote the decree into the legislation, calling for the development of affluent
limitations by July 1, 1984 for all "toxic pollutants referred to in Tabla 1
of Committee Print Numbered 95-30 of the Committee on Public Works and
Transportation of the House of Representatives. .  .  ."  (Section 201(3)(2)(C)),

-------
                                   2-16
The list is identical to that issued in the Consent Decree.5  The
Administrator also is free to list other pollutants considered toxic.8

    Effluent limitations (or standards) for toxic pollutants are the  subject
of several sections in the Clean Water Act.  These sections are analyzed  below
in light of the statutory language, legislative history, and relevant case
lav.   The sections addressed are:

         •   Section 30100(2) (A) which requires that "best
             available technology" be used;

         •   Section 304(b)(2) which sets  forth factors to be
             considered when adopting or revising effluent
             limitations that require the  "best measures and
             practices available;" and

             Section 307(a)(l),  (2), and (4) which deal with toxic
             effluent standards.

    Sections 301(b)(2)(A) and 304(b)(2) are concerned with the imposition of
best available technology7 (BAT) for effluent controls on sources that
discharge toxic pollutants.  Section 30100(2) is the general requirement that
effluent limitations applying BAT be placed on sources discharging toxic
pollutants, and Section 304(b)(2) sets forth guidelines that EPA is to  follow
in setting these effluent limitations.  These two sections and their
legislative history are discussed below, followed by an analysis of how courts
have dealt with the concept of BAT.

    Section 301(bU21 (A):  General BAT Requirement.  Section 301 deals  in
part wita toxic pollutant effluent limitations that must be met by a  certain
deadline, generally by July 1, 1984.  To comply, sources oust apply BAT.  In
    !A recent case, £D~
that the Consent Decree remains  in effect.   Industry petitioners  claimed  that
the 1977 amendments to the Clean Water Act  supersede the  decree,  but  the  Court
held that Congress intended the decree to remain  in effect  to  supply  the
details missing in the legislative changes.

    !As of July I, 1979, six classes of  chemical  substances  had been
designated as toxic:  aldrin/dieldrin, DDT,, endrin, toxaphene, benzidine,  and
poiychlorinated biphenyls.  The  effluent limitations for  these pollutants  are
set forth at 40 CFR 129.

    73AT is the most strict control requirement imposed under  the Clean
Water Act.  Its requirements, discussed  later  in  the text,  are more strict
than those of the "best conventional pollution control technology."

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                                   2-17
requiring BAT to be applied, Secrion 301(b)(2)(A) imposes the important
qualifier that BAT must be "economically achievable" for a particular category
or class of point sources.  Two key characteristics of BAT are that it (1)
must result ia "reasonable further progress toward the national goal of
eliminating the discharge of all pollutants," and (2) must require complete
elimination of discharges if such elimination is "technologically and
economically achievable"  (as determined on the basis of information available
to SPA) for categories or classes of particular point sources.

    The BAT required by Section 301(b)(2)(A) is not an absolute requirement
but one to be tempered by practical consideration.  For example, during the
House debate on the Conference Committee Report, one of the conferees nosed
that when SPA identifies BAT under §301(b)(2)(A), it "must rake into account
energy requirements as one factor in determining the measures and practices
available to comply with" the effluent limitations being set  [Legislative
History, Vol. 1, pp. 258-269.]  This tempering or balancing becomes more
apparent in light of the guidelines found in §304(b)(2).

    Section 3Q4rb1(21:  Guidelines for Setting Effluent Limitations Requiring
BAT.  This section addresses the adoption and revision of effluent
limitations and directs EPA to publish regulations that provide guidelines for
effluent limitations.  These regulations must:

         •   identify (using "amounts of constituents and
             chemical, physical, and biological characteristics of
             pollutants") the degree of effluent reduction that can
             be attained by applying the "best control measures and
             practices achievable," including (i) treatment
             techniques,  (ii) process and procedure innovations,
             (iii) operating methods, and (iv)  other alternatives;
             and

         •   specify factors to be considered in deciding what are
             the "best measures and practices available" to comply
             with §301(b)(2), such factors to include:  (i) age of
             equipment and facilities, (ii) process employed, (iii)
             engineering aspects of control techniques, (iv) process
             changes, (v) costs of achieving effluent reductions,.
             and (vi) non-water quality environmental impact.

    The legislative history of this section suggests three important ground
rules SPA is to follow.  First, the cost of a particular technology is not
determinative:

         While cost should be a factor, ... no balancing test will
         be required.  [EPA] . . .'will be bound by a test of
         reasonableness.  In this case, the reasonableness of what
         is "economically achievable" should reflect an evaluation
         of what needs to be done to move toward the elimination of

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                                   2-18
         the discharge of pollutants and what is achievable through
         the application of available technology—without regard to
         cost.  [Legislative History, Vol. 1, p. 170.]

Second, the determination of what is BAT is not made on a case-by-case basis.
Rather, it was the intention of the Conference Committee:

         that the factors described in Section 304(b) be considered
         only within classes or categories of point sources and that
         such factors not be considered at the time of the
         application of an effluent limitation to an individual
         point source within such a category or class.  [Legislative
         History. Vol. 1, p. 172.]

Third, EPA is expected to require state of the art technology, whether
currently being practiced or only demonstrated to be effective.

         In making the determination of "best available" the
         Committee expects [EPA]  ... to apply the same principles
         involved in making the determination of best practicable
         .  .  . except that rather than the range of levels
         established in reference to the average of the best
         performers in an industrial category the range should at
         a minimum be referenced to the best performer in any
         industrial category.
         As used in this bill the concept "best available control
         technology" is intended to mean that  [EPA]  .  .  . should
         examine the degree of effluent control that has been or can
         be achieved through the application of technology which is
         available or normally can be made available.  This does not
         mean that the technology must be in actual  routine use
         somewhere.  It does mean that the technology must be
         available at a cost and at a time which  [EPA]  .  . .
         determines to be reasonable, and that the technology has
         been adequately demonstrated if not routinely applied.
         fLegislative History, Vol. 2, pp. 1468-1470.]

What the statute and its legislative history suggest is  that the determination
of what is BAT should be a balancing decision best described as a  "reasonable"
choice.  As the next section demonstrates, courts have  followed this
interpretation of BAT.

    BAT in the Courts.  The courts have addressed two  important issues
related to BAT--the state of the art technology required and how much weight
should be given to costs.

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                                   2-19
    Three cases outline what EPA's responsibilities are regarding state of the
art technology.

         •   Tanner's Council of America, Inc. v.  Train, 540 F.2d
             1138 (4th Cir. 1976).  The court held that EPA may look
             to the industry's best perforner, and EPA may even
             assess technologies that have not been applied if there
             is a "reasonable basis" for believing that the
             technology will be available fay the appropriate
             statutory deadline.  Note, however, the court's
             statement:  "What is a reasonable belief of today
             [1976] that these (best available technology standards]
             .  .  .  can be achieved by 1983 would .  .  .  not
             necessarily be a reasonable belief in 1981."  The court
             indicated that as the deadline for applying the
             standard grew nearer, EPA would need a stronger
             justification for imposing its BAT standards on the
             leather tanning and finishing industry than required at
             what was then an early stage of setting the 1983
             regulatory standards (at p. 1196).  In general, then,
             as the statutory deadline for BAT draws closer, courts
             will expect a more precise determination of what the
             state of the art technology will be when the deadline
             arrives.

         •   U.S. Steel Corp. v. Train, 556 ?.2d 822 (7th Cir.,
             1977).  The court noted that a state's effluent
             limitations can be technology-forcing, but federal
             effluent limitations must be technology-based  (at
             p. 838).  Nevertheless, two later cases in different
             circuits (BASF Vyandotte Cora, v. Costle.  598 F.2d
             637, 646-651 (1st Cir. 1979) and Weyerhaeuser Company
             v. Costle, 590 F.2d 1011 (B.C. Cir.,  1978) suggest
             that EPA has some technology forcing authority.*

         •   Hooker Chemicals and Plaxtics Corp. v. Train. 537
             F.2d 620 (2d Cir. 1976).  The court determined that,
             although a pollution control device can be considered
             "available" even though no plant in a given industry
             has adopted it, the administrative record compiled by
    'The "technology forcing" is somewhat limited, and seems to apply
primarily to industrial categories that are uniformly deficient in their
control practices.  The extent of technology forcing permitted for these
categories is apparently limited to what is being utilized in other industrial
categories.  This is not a strong version of "technology forcing".

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                                   2-20
             EPA must support the conclusion that such technology is
             both "feasible" and "reasonably .  .  .  expected" to
             provide the required effluent reduction when applied to
             a particular industry (at p. 636).

Other cases support the notion that cost considerations are nor. dispositive in
the determination of what constitutes BAT.  Three cases are noted below:

         •   American Meat Institute v. EPA, 526 F.2d 422 (7th
             Cir., 1975).  Although EPA is not required to perform a
             formal cost-benefit analysis, it still must consider
             costs in determining what is EAT (at p. 462-463).

         *   American Iron and Steel Institute v. EPA, 526 r.2d
             1027 (3d Cir., 1975).*  In determining "best
             available technology economically achievable," the
             court held that compliance cost was not of primary
             importance (at p. 1051).

             ?MC Coro. v. Train. 539 ?.2d 973 (4th Cir., 1976).
             The Court noted that Congress "has determined that many
             intangible benefits of clean water justify vesting
             [EPA] .  . . with broad discretion, just short of being
             arbitrary or capricious, in [its]  .  .   . consideration
             of cost of pollution standard" (at p.  979).

    Although cost of compliance is not meant to be a determinative factor  in
setting 3AT, Section 301(c) does allow variances to BAT to be issued to
individual point sources, and cost of compliance is one factor to be
considered in issuing a variance.  The Supreme Court recently settled a
controversy about the granting of variances from the control standard imposed
under BFT and BAT.18  Section 301(c) allows EPA to vary the requirements of
BAT with respect to an individual point source (note that BAT is set at a
uniform level for categories and classes of point sources) if (1) the variance
represents "the maximum use of technology within the economic capability of
the" source and (2) the variance "will result in reasonable further progress"
toward eliminating pollutant discharge.11
     'Motions granted 560 F.2d 589, 568 F.2d 284, cert, den. 435 U.S. 914.

    10See EPA v. National Crushed Stone Association, 49 Law Week No. 22,
pp. 4008-4013 (December 2, 1980).

    I10ne lower court had interpreted this provision to be applicable to
variances from BPT as well--that the individual source's ability to pay for
the required BPT could be taken into account.  The  Supreme Court rejected  this
view and held that the economic situation of an individual point source's
owner or operator could be a factor only in BAT variances.

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                                   2-21
    Summary of BAT.  The BAT requirements in Sections 301(b).(2) and 30C(b)(2)
are not absolute in nature.  EPA, in its determination of what constitutes
3AT, is to take a reasonable approach.   The reasonable approach should take
into consideration the cost of control and characteristics of the incustry foi
which BAT is being determined.  Nevertheless, the overall goal of effluent
limitations is to achieve complete elimination of discharges.

    Section 307:  Toxic Effluent Standards.lz  Section 307(a) sets forth
important guidelines for EPA to follow in setting toxic effluent standards.
Three of these guidelines are discussed below.

        (1)  Section 307(a)(i) sets forth both what substances are
             to be included on a list of toxic pollutants and what
             factors are to be considered in adding to or
             subtracting from this list.  The factors to be
             considered in revising the list include:  (i) toxicity
             of the pollutant; (ii) persistence; (iii)
             degradability; (iv) usual or potential presence of
             affected organisms in any waters; (v) importance of
             affected organisms; and (vr) nature and extent of
             effect of toxic pollutants on such organisms.  EPA
             decisions under Section 307(a)(1) are subject to
             judicial review applying the "arbitrary and capricious"
             standard--a standard that gives the agency great
             discretion.

        (2)  Section 307(a)(2) indicates that substances on the
             toxic pollutants list are subject to effluent
             limitations based on "best available technology
             economically achievable for the applicable category or
             class of point sources" as established by Sections
             30Kb) (2)(A) and 304(b)(2).  EPA may, in its
             discretion, promulgate an effluent standard for toxic
             pollutants "which, if an effluent limitation is
             applicable to a class or category of point sources,
             shall be applicable to such category or class only if
    l2"Effluent standards" and "effluent limitations" seem to be used
interchangeably.  One commentator notes that "[t]he Act defines an effluent
limitation [in section 502(11)] consistently with the conventional
understanding of an effluent standard. .  ."  Rogers, op. cit., p. 451.  As
used in Section 307(a), the "limitation" can be thought of as applying to a
category of source, and a "standard" can be thought of as applying to a
particular pollutant.

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                                   2-22
             such standard" is strictei.13  In setting such an
             effluent standard (which can include a prohibition),
             EPA must take into consideration:  (i) toxicity of the
             pollutant; (ii) the persistence of the pollutant; (iii)
             the degradability of the pollutant; (iv) the usual or
             potential presence of affected organisms in any waters;
             (v) the importance of such affected organisms; (vi) the
             nature and extent of the effect of toxic pollutants on
             such organisms; and (vii) the extent to which effective
             control is being or may be achieved under other
             regulatory authority.   A standard promulgated under
             Section 307(a)(2) is subject to judicial review based
             on the "substantial evidence" test--a harder test to
             satisfy than the "arbitrary and capricious" test by
             which decisions on adding to or subtracting from the
             toxic pollutant list are judged.lfc

        (3)  Section 307-(a)O) requires that any effluent standard
             promulgated under 307 "be at that level which [EPA]
             .   . .  determines provides an ample margin of safety."

    Legislative History of Section 307.  The legislative history of the
section indicates that tnere were two significant concerns about the standa:
setting authorized.  First, toxicity is dependent, at least in part, on the
interaction of the pollutant with the water into which it is discharged.

         [T]he toxicity of some "pollutant" will depend upon the
         species or valence of the pollutant present in any
         discharge.15  [When this is so]  . . . , it is expected
    :iThis provision of Section 307(a)(2) deals with two distinct control
strategies.  First, effluent limitations may be set for categories or classes
of point sources.  These limitations would apply to any pollutant emitted
from that point source.  Second, an effluent standard can be set for a
particular toxic pollutant; regardless of what kind of point source emitted
this toxic pollutant, the standard would apply.  Section 307(a)(2) indicates
that toxic pollutants will be subject to the BAT standard generally applicable
to the point source from which it is emitted unless EPA promulgates a toxic
pollutant-specific standard that is stricter than the emission limit already
applicable.  The stricter standard takes precedence over the pre-existing
emission limitation.

    14The reason for the stricter standard is due to relative severity of
what each section authorized EPA to do—under 307(a)(l) EPA considers only the
appearance of a substance on a list, under 307(a)(2) EPA can ban discharge of
the substance.

    lsThe terms "species" and "valence" refer to the makeup of an atom of
the pollutant and affect how the pollutant reacts to its environment.

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                                   2-23
         that standards should be sst in terms of -he specific
         species or valence.  Care should be taken, however, to be
         reasonably assured that physical, chemical or biological
         processes in the receiving waters will not cause changes in
         the species or valence.  [Legislative History, Vol. 1,
         p. 799.]

Second, the House Report made it very clear that the costs of compliance wara,
at best, a secondary consideration in setting effluent standards for toxic
pollutants.

         Less stringent standards for an industry will not be
         established simply because it is more expensive to treat
         wastes to eliminate or reduce toxic discharges in one
         industry than in another.  The Committee considers that the
         discharge of toxic pollutants are [sic] much too dangerous
         to be permitted on merely economic grounds.  [_Ibid. , pp.
         799-800.]

    Case Law.  The case law generally indicates that determinations of
tcxicity and the need for effluent limitations or standards are within tr.a
expertise of EPA, and the courts will not disturb a decision by the Agency
that is based on substantial evidence.15

    Summary.  The following points summarise the situation in which effluent
limitations for toxic pollutants are applied.

         •   The substances involved are toxic pollutants' as
             defined in Section 502(13).

         •   The harms to be avoided also are noted in Section
             502(13):  death, disease, behavioral abnormalities,
             cancer, genetic mutations, physiological malfunctions
             (including malfunctions in reproduction) or physical
             deformations.
     lsSee e.g., ZSF v..EPA. 598 ?.2d 62  (D.C. Cir. 1978) upholding EPA's
PC3  regulations; Hercules, Inc. v. EPA,  598 F.2d 91  (D.C. Cir.  1973)
upholding EPA's effluent standards for toxaphene and endrin.  The substantial
evidence test requires a reviewing court to defer to the agency's chores
between "two fairly conflicting views,"  even where the court would have been
justified in reaching the opposite conclusion if the court were hearing the
case as the trier of fact.  (E3F  court citing Universal Camera Corp. v.
NLRB, 340 U.S. 474, 488  (1951)).  In Hercules, the court noted that  in
reviewing a numerical standard "we must  ask whether  the agency's numbers  are
within a 'zone ci reasonableness,' not whether its numbers are precisely
right" (at p. 107).

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         1   The level cf causality seems to be fairly aigh.  The
             pollutant is considered toxic only if, on the basis of
             information available to EPA, it will cause the harms
             mentioned above.  This appears to require ZPA to have
             more than a suspicion or reasonable doubt about the
             toxicity of a pollutant.  That the agency must have a
             scientific basis for determining that the pollutant
             will cause the harm, however, is not necessarily the
             intent of the Act.   In EOF v. EPA, supra, the court
             noted that "the 'ample margin of safety' provision
             [Section 307(a)(4)] directs EPA to guard against
             incompletely known dangers."  The Court specifically
             disagreed with an industry contention "that EPA must
             demonstrate the toxicity of each chemical it seeks to
             regulate through studies demonstrating a clear line of
             causation between a particular chemical and harm to
             public health or the environment" (at p. 83).  In that
             case the court upheld EPA's use of information about
             more chlorinated PCBs as the basis for regulating less
             chlorinated PCBs (about which little was known).

         *   Factors to be considered in dealing with toxic
             pollutants are numerous.  These factors can be divided
             into two broad categories:  factors to be considered in
             designating a pollutant as'"toxic" and factors to be
             considered in setting effluent limitations for
             particular toxic pollutants.  In the former category
             such factors as the pollutant's toxicity, persistence,
             and degradability are to be considered.  The latter
             category includes such added factors as whether the
             standard is economically achievable for a class of
             point sources, the age of equipment and facilities, and
             the engineering aspects of control techniques.

Because the harm involved in this situation is more severe than in previously
discussed situations, the measures (notably BAT) to guard against this harm
are correspondingly more strict.  The level of causality, however, which must
be found before these stricter measures are justified is also more difficult
to satisfy.

    Non-Conventional Pollutants.  Non-conventional pollutants are the third
category of pollutant for which effluent standards are issued for existing
sources.  This category includes any pollutant not classified as conventional
or toxic.  Under Section 301, discharges of these pollutants are to be limited
by July 1, 1987 at the latest to levels achievable through the application of
the "best available technology economically achievable (BAT)".  BAT is defined
here as it was above for toxic pollutants.

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                                   2-25
    This catch-all category might be expected to be large, but EPA currently
regulates less than ten "non-conventional" pollutants.  Some non-conventional
pollutants, however, are widely discharged.  While a limited number of
pollutants are regulated under this provision, a large number of
industries:r are subject to regulation because of their discharge of
non-conventional pollutants.

    Section 301(g) allows non-conventional pollutant point sources to obtain
modification of the BAT requirements imposed by Section 30i(b)(2)(A).   This
modification is based on water qualify considerations (unlike the Section
301(c) modification which is based on economic considerations).   The granting
of this modification depends on several factors:  (1) the modification must,
at a minimum, satisfy the requirements of 3PT or, in some instances, stricter
limitations (301(g)(1)(A)); (2) the modifications must not place additional
burdens on other point or nonpoint sources (301(g)(1)(B)); and (3) the
modification cannot interfere with attainment or maintenance of that water
quality necessary to protect public water supplies, animal life, recreational
activities, and "will not result on the discharge of pollutants which may
reasonably be anticipated to pose an unacceptable risk to human health or the
environment because of bioaccumulation, persistency in the environment, acuta
toxicity, chronic toxicity (including carcinogenicity, mutagenicity or
teratogenicity), or synergistic propensities" (301(g)(1)(C) emphasis added).

    The following points summarize the situations in which effluent
limitations for non-conventional pollutants from existing sources are applied.

         •   The substances involved are non-conventional
             pollutants, defined above.

         •   The harm to be avoided is the discharge of
             pollutants in quantities which may reasonably be
             anticipated to pose an unacceptable risk to human
             health or the environment due to bioaccumulation,
             persistency, or toxicity.

         •   The level of causality is not explicit, but  it is
             clear that the modification of the integrity of water
             constitutes pollution and triggers the application of
             the effluent limitations.  In deciding whether a
             particular point source will be granted a modification
             from BAT requirements, discharges cannot be permitted
             that "may reasonably be anticipated to pose an
             unacceptable risk."
    17They are listed at 40 CFR 122, Appendix A.

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                                   2-26
         •   Factors to be considered in setting the standards
             are detailed above and include costs of achieving the
             required effluent reduction, age of equipment and
             facilities,  and nonwater quality environmental
             impacts.  In allowing a modification, EPA must consider
             a pollutants' bioaccumulation, persistence, toxiciry,
             and synergistic propensities.

2.   Effluent Standards for New Sources--National Standards of Performancel'

    To further achieve the water quality standards elaborated under Section
303, the administrator is authorized to set National Standards of Performance
for all new sources of water pollution.  These standards would be similar to
those demanded by effluent limitations, but could be set at different levels
depending on the economics of new source pollution control versus retrofit
pollution control.  Under this provision, the Administrator is to promulgate
standards for new pollution sources on an industry by industry basis.  In the
1977 Amendments, 27 industries were identified for which the Administrator was
to promulgate standards.   See Section 306(b)(1)(A).   The standards of
performance were to be set at levels which reflect "the greatest degree of
effluent reduction which the Administrator determines to be achievable through
application of the best available demonstrated control technology, processes,
operating methods, or other alternatives including where practicable, a
standard permitting no discharge of pollutants"  (Section 306(a)(l)).  The
Administrator is to take into account "the cost of achieving such effluent
reduction, and any non-water quality environmental impact and energy
requirements" (Section 306(b)(1)(3)).

    The situations for applying national standards for performance to new
sources can be summarized as follows:

         •   The substances being regulated are "pollutants" as
             defined in Section 502(6) and which are the general
             concern of the Act.

         •   The harm involved and to be avoided is that
             generally associated with the degradation of the
             nation's waters--ill effects on health and welfare.
    :tThe new source performance standards are distinct from the standards
to be set for existing sources.  Existing sources are subject to a two-step
process, BPT and BAT, while new sources are expected from the beginning to
make a maximum effort to control pollutant discharges.

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                                   2-27
         •   The level of causality which must exist between the
             harm and. the substance regulated, as with most other
             sections, is not specifically articulated.
             Technically, the mere introduction of the pollutant
             into water is all that is necessary to trigger the
             application of this section.

         •   Factors to be considered in setting national
             standards of performance include the cost of reducing
             effluents to the level required and nonwatar quality
             environmental impacts.

3.   Effluent Standards for Publicly Owned Treatment Works

    Publicly owned treatment works (POTWs) are not subject to the effluent
limitations of Section 301.  Instead, PGTWs are to comply with limits set by
the administrator under Section 304(d)(l).  The Administrator is to publish
"information in terms of amounts of constituents and chemical, physical, and
biological characteristics of pollutants, on the degree of effluent reduction
attainable through the application of secondary treatment" (Section 30^(d)(l)).
The secondary treatment standards, defined in terns of three parameters
(suspended solids, pH, and biochemical oxygen demand),13 wera to have been
net by July 1, 1977.  Secondary treatment standards, therefore, are based on
traditional water quality parameters, whereas effluent limitations applicable
to private sources are based on specific pollutants.

    By July 1, 1983, Section 301(b)(2)(3) mandates that PQTWs are to satisfy
the requirement of Section 201(g)(2)(A) that there be in Use "the best
practicable waste treatment technology over the life of the works."  Section
201 suggests that determining what "best practicable technology" entails
requires consideration of all environmental conditions relevant to a specific
proposed water treatment plant.  In addition, this determination requires
consideration of alternative treatment techniques and consistency with the
purposes of Title II of the Act.  This interpretation was upheld in
Environmental Defense Fund Inc. v. Costle, 439 F. Supp. 980 (B.C.N.Y.,
1977).  Privately owned pollutors are to comply with the pretreatment controls
of Section 307 if they discharge pollutants into a POTW.

4.   Pratraatment Standards

    Sections 307(b) and  (c) provide for the establishment of pratraatsent
standards for sources of pollutants that pass through or interfere with the
operations of PGTWs.  Pretreatment standards are to be established for
    lsThe rales applicable to POTWs are set forth at 40 CFR 133.  This
section describes the minimum water quality level to be attained by the
"secondary treatment" provided by POTWs for these three parameters'.

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                                   2-28
categories of both existing sources and new sources simultaneously.  The
statutory criteria for such standards are virtually identical with one
exception.  For new sources, pretreatment standards are to be promulgated for
pollutants which "may" interfere or pass through POTVs; for existing sources,
only a pollutant which in fact "interferes with or passes through" PCTWs are
subject to pretreatment standards.

    Finally, with respect to toxic pollutants covered by Section 307(a),
pretreatment standards for existing sources may be revised to reflect the
removal of toxic pollutants by the POTWs.  To qualify, the discharge from
PGTWs must net violate the effluent standard or limitation which would apply
to a direct discharger (§307(b)(1)).

OIL AND HAZARDOUS SUBSTANCES

    Tae third mechanism provided for achieving the goals of the Clean Water
Act is found in Section 311 which prohibits discharges28 of "oil and
hazardous substances."  Oil is defined in the Act to mean "oil of any kind or
in any form including, but not limited to petroleum, fuel oil, sludge, oil
refuse, and oil mixed with wastes other than dredged spoil. ..."  (Section
311(a)).  A hazardous substance is one which presents "an imminent and
substantial danger to the public health or welfare, including, but not limited
    2""Discharges" is defined to include "any spilling, leaking, pumping,
pouring, emitting, emptying or dumping" (Section 311(a)(2)), but excluded from
this definition are three discharge situations related to permits issued under
Section 402:

        (1)  discharges that are in compliance with a permit issued
             under Section 402;

        (2)  discharges that result "from circumstances identified
             and reviewed and made a part of the public record with
             respect to a permit issued or modified" under Section
             402, and that also are subj.ect to a condition in such
             permit; and

        (3)  continuous or anticipated intermittent discharges from
             a point source "that are identified in a permit or
             permit application uncer Section 402" and that "are
             caused by events occurring within the scope of relevant
             operating or treatment systems".

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                                   2-29
to, fish, shellfish, wildlife, shorelines, and beaches" (Section
    Administrative responsibility in this area is assigned to the President.
The President is required to determine "those quantities of oil and any
hazardous substances the discharges of which .  .  .  may be harmful to public
health or welfare of the United States" (Section 311(b)(4)).  Any discharge
(either intentional or unintentional) of any oil or other hazardous substancas
in amounts equal to or greater than those cited as raportable is prohibited.
While authority to institute requirements designed to prevent such discharges
is present under this section, the provisions concentrate in large part en
incident reporting and clean-up liability for spills which do occur.

    Many chemicals have been designated as "hazardous".22  Most but not all
of the substances designated as hazardous under Section 311 have also been
designated as conventional, toxic, or non-conventional pollutants far effluent
limitation purposes.  The reason for the dual designation is that the focus of
Section 311 deals with discharges (generally discrete events that are
accidental) that pose "an imminent and substantial danger to the public haalth
or welfare;" effluent limitations relate more to discharges that occur as a
normal part of ongoing activities by the discharger.  Section 311 is concerned.
primarily with preventing and ameliorating the discharge of hazardous
substances, and, consequently, it deals with the issues of liability, incident
reporting, and clean-up.  Section 311(b)(4) requires regulations to be
promulgated that establish at what quantity a hazardous substance aiay be
harmful to the public health or welfare; any discharge at cr in excess of
these quantities is prohibited except "in quantities and at times and
locations or under such circumstances or conditions as [determined] ... by
regulation . . . not to be harmful" (Section 311(b)(3)).  In addition,
chemicals identified as "hazardous" but which meet the permit requirements of
Section 402 are specifically excluded from regulations under Section 211
(Section 311(a)(2)).
    2 1The "Comprehensive Environmental Response, Compensation, and Liability
Act of 1980" (Superfund) was enacted on December 3, 1980.  It contains
provisions governing situations involving hazardous substances that ara
addressed under Section 311 of the Clean Water Act.  Although the Superfund
legislation apparently does not completely pre-empt Section 311's authority,
the Superfund Act does take precedence if it conflicts with a provision of
Section 311 (see Section 304(c) of the Superfund Act).  See the statutory
review of Superfund in Chapter 3 of this volume.

    22These designations are found in 40 CTS. 116.  See CVA regulatory review
for further discussion.

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                                   2-30
    Authority to establish, preventative measures is created by Section
211(j).  Here the Act calls for regulations "establishing procedures, methods,
and equipment and other requirements for equipment to prevent discharges of
oil and hazardous substances from vessels and from onshore facilities and
offshore facilities, and to contain such discharges" (Section 311(j) (1) (B)).
This authority has since been delegated in part to the EPA and in part  to  the
Coast Guard under Executive Order 11735. 23

    If a discharge does occur, the person in charge of the vessel or facility
is to "immediately notify the appropriate agency of the United States of such
discharge" (Section 311(b)(5)).  Persons failing to provide notification are
subject to fine or imprisonment.  The President is to establish a National
Contingency Plan for the mitigation and removal of discharges.  The owner  of
the vessel or facility from which the discharge occurs is liable for costs
incurred in removal and restoration of natural resources damaged by the
discharge up to the limits specified in the Act.

    The situations in which the regulations under Section 311 are invoked  are
summarized below:

         •   The substances being regulated are oil and hazardous
             substances as defined in the section.

         •   The harm generally to be avoided is an "imminent and
             substantial danger to the public health and welfare".

         •   The level of causality involved with designating
             hazardous substances is "presents an imminent and
             substantial danger to the public health or welfare".
             The use of "present" suggests that the causal link need
             not be irrefutably determined.  This is in contrast to
             the definition of "toxic substances" (§502(11)) for
             which the causal link must be more surely established.
             The establishment of reportable quantities is
             contingent on the "may be harmful" criterion.

         •   "actors to be considered in designating substances
             as  'hazardous" include whether the substance imminently
             and substantially endangers "fish, shellfish, wildlife,
             shorelines, and beaches," and other aspects of the
             "public health and welfare."  Tnere is a statutory
             mandate that there are to be no discharges of oil or
             hazardous materials; the absolute nature of this policy
             (see Section 311(b)(l)) indicates that consideration of
             costs does not enter into the designation of a
             substance as "hazardous."
    I338 Federal Register 21243  (1973).  EPA regulations are at 50 CFR
112.  Coast Guard regulations at 33 CTR  154-156.

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                                   2-30
      EFFLUENT LIMITATIONS AND .PERFORMANCE AND PRETREATMSNT STANDARDS--
                              REGULATORY REVIEW
    The effluent limitations required by Section 301 of the CVA and other
performance standards are the primary mechanisms for regulating pollution  at
the point of discharge, as well as the means by which national water quality
standards are to be achieved, as discussed in detail in the Statutory Review.

    Section 301 (a) of the CVA states that "except as in compliance with  -his
Act, the discharge of any pollutant by any persons shall be unlawful."  The
exceptions are defined in subsequent sections by the level cf technology
required of various classes of dischargers for specific types of pollutants.
It is up to EPA, however, actually to identify a given technology as the  "best
available," "best practicable," etc.  Specifying a pollution control process
as representing a certain level of abatement does not require all sources  to
install that technology, as EPA has declared specifically in all the
regulations proposed through 1980:

         The proposed regulations do not require the installation of
         any particular technology.  Rather, they require
         achievement of effluent limitations representative of the
         proper application of these technologies or equivalent
         technologies.   [Emphasis added.]

Thus, if a best available technology (BAT) control process is identified which
limits total zinc discharged to 0.07 pounds per 1000 pounds of finished prod-
uct,1 a regulated source may use any controls or combination of controls
which achieve the specified limitation.

     Section 306(b)(l)(A) of the 1974 Act directed EPA to publish effluent
guidelines and performance standards, for, at a min-imum, twenty-seven specific
industrial categories.   Regulations for these sources and an additional
sixteen categories designated by EPA were published between May, 1974 and
     xThe effluent limitations for 3PT, BCT, BAT and NSPS are generally
expressed as mass limitations (Ibs/1.000 Ibs raw material) and are calculated
by multiplying three figures:  (1) effluent concentrations determined  from
analysis of control technology performance data, (2) wastewatsr flow for  each
subcategory, and (3) any relevant process or treatment variability factor
(e.g., maximum month vs. maximum day).  This basic calculation was performed
for each regulated pollutant or pollutant parameter for each subcategory  of an
industry.  Effluent limitations for PSES and PSNS are generally expressed as
allowable concentrations in milligrams per liter (mg/1).

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                       :LEAN WATER ACT--REGULATORY REVIEW
INTRODUCTIDN

    The following discussion reviews the regulations designating hazardous
substances under the Clean Water Act (CVA).   The discussion is organized into
three sections:

    (1)  Effluent Limitations, Performance,  and Pretreatment Standards,

    (2)  Toxic Pollutant Effluent Standards, and

    (3)  Discharges of Hazardous Substances

    The first section describes pollutants which are regulated (see 40 CFR
405-460) based exclusively on technological  controls.  Effluent limitations
are required by Section 301 of the CWA for conventional, toxic, and
non-conventional pollutants.  New source performance standards for regulating
all pollutants at the point of discharge are reviewed.  In addition,
pretreatment standards promulgated under Section 307(b) and (c) for discharges
into a publicly-owned treatment work (POTW)  are included.  The methods EPA
uses to establish the standards and the types of pollutants controlled in each
case are examined.

    The next section reviews effluent standards for toxic pollutants based on
toxicological factors as well as economic and technological feasibility.
Toxic Pollutant Effluent Standards, 40 CFR 129, are promulgated under Section
307 of the CWA and are intended to control pollutants which EPA determines
pose serious environmental threats.  Toxic Pollutant Effluent Standards are
applicable to pollutants emitted from point sources  regulated under Section
301 of the CWA (effluent limitations for toxic pollutants) only if the
standards promulgated under Section 307 are more stringent.

    The final section examines chemicals designated  as "hazardous substances"
under Section 311 cf the CWA.  Toxicological characteristics and discharge
potential are the two principal criteria EPA relies  on to designate these
substances as hazardous.  The regulations authorized by Section 311, 40 CFR
116-117, establish reportable quantities for all designated hazardous
substances.  The methodology EPA employs to determine those quantities of
hazardous substances which, when discharged, "may be harmful" to the public
health or welfare is reviewed.

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                                   2-31
June, 1976.  Exhibit 2-3 presents a chronology of the effluent guidelines,
performance and pretreatment regulations promulgated through January 1931.
The primary emphasis in this round of rule-making was placed on identifying
and achieving the best practicable technology (3PT) to control conventional
pollutants in each of the regulated industries.

     The 1977 Amendments shifted the focus of the CWA away from conventional
pollutants and on to toxic pollutants, specifically the sixty-five priority
pollutants identified in the 1976 Settlement Agreement.  Moreover, the 3?T
requirements of the 1974 Act were replaced by the goal of achieving, by
July 1, 1984, the "best available technology economically achievable" (BAT),
in the twenty-one priority industries specified in the 1976 Settlement
Agreement.  Achievement of BAT, according to EPA, is the first step in asking
reasonable further progress toward the national goal of eliminating the
discharge of all pollutants.  The remainder of this analysis will focus on
this latest round of regulations required by the 1977 Amendments.

     As of January 1981, EPA has proposed effluent guidelines and performance
and pretreatment regulations for ten of the twenty-one priority industries
specified in the 1977 Amendments and listed in Exhibit 2-4.  A review cf these
proposed standards (none of which had been promulgated as final rules)
highlights certain points which should be mentioned at the outset of this
discussion.

          •    First, as directed by the CWA, the standards are
               wholly technology-based.  There is no indication in
               any of the Preambles or other supporting documenta-
               tion that the Agency specifically considered differ-
               ential health or other effects in determining the
               levels of control required.  Proposed standards
               simply reflect the effluent, limitations achievable
               under a particular level of technological controls.

          •    Secondly, the shift in emphasis from conventional
               to toxic pollutants is evidenced by the fact that, of
               the pollutants selected for regulation, the majority
               are known to have acute or chronic toxic or
               carcinogenic effects.  Far more effort has been given
               to the regulation of these substances than to the
               classical pollutants and pollution parameters.

          •    Finally, the most-cited factor used to identify
               abatement technologies as representing a particular
               level of control has been that of "reasonable cost".
               Although the term is interpreted somewhat differently
               from standard to standard (as will be discussed in
               greater detail below), consideration cf this factor
               appears to be essential in establishing both effluent
               guidelines and performance standards.

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                                   2-32
                                 EXHIBIT 2-3

                REGULATORY CHRONOLOGY:  EFFLUENT LIMITATIONS,
                   PERFORMANCE AND PRETREATMENT STANDARDS
        DATE

May 1974 to
June 1976
July 28, 1978
July 2, 1979
July 30, 1979
August 29, 1979
October 29, 1979
October 31, 1979
November 29, 1979
December 21, 1979
    EPA REGULATORY ACTION

EPA Proposed arid Promulgated
Effluent Guidelines for 27
Industrial Categories

Designations and Proposed
Additions to Conventional
Pollutants List

Proposed Effluent Guidelines,
Performance and Pretreatment
Standards for Leather Tanning
and Finishing Industries

Final Rule Identifying Conven-
tional Pollutants

Final Rule Establishing BCT to
Replace BAT for Thirteen
Industries, and Withdrawing
BAT for Certain Sub-Categories
of These Industries

Proposed Effluent Guidelines,
Performance and Pretreatment
Standards for Textile Mills

Proposed Effluent Guidelines,
Performance and Pretreatment
Standards for Timber Process-
ing Plants

Proposed Effluent Guidelines,
Performance and Pretreatment
Standards for Gum and Wood
Chemicals

Proposed Effluent Guidelines,
Performance and Pretreatment
Standards for Petroleum Re-
fining Facilities
REFERENCE

Codified at
40 CFR Parts
405-460

43 FR 32S57
44 FR 38746
44 FR 44501
44 FR 50732
44 FR 62204
44 FR 62S10
44 FR 68710
44 FR 75926

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                                   2-33
                                 EXHIBIT 2-3

                REGULATORY CHRONOLOGY:  EFFLUENT LIMITATIONS.
                   PERFORMANCE AND PRETREATMENT STANDARDS
                                 (CONTINUED)
        DATE

January 3, 1980
July 24, 1980
October 14, 1980
December 1, 1980
December 15, 1980
January 6, 1981
    SPA REGULATORY ACTION

Proposed Effluent Guidelines,
Performance and Prstraatment
Standards for Paint Formulat-
ing Facilities and Ink Formu-
lating Facilities

Proposed Effluent Guidelines,
Performance and Pretreatment
Standards for Inorganic Chemi-
cal Producers

Proposed Effluent Guidelines,
Performance and Pretrsatment
Standards for Steam Electric
Power Plants

Petition by American Iron and
Steel Institute to Add Ammonia
and Sulfide to Conventional
Pollutant List Denied by EPA

Portions of Effluent Guidelines
for Phosphate Manufacturing and
Meat Products Revoked by EPA in
Response to Seventh Circuit
Court Decision to Remand These
Guidelines to EPA [American Meat
Institute v. EPA. 526 F.2d 442
(7th Cir. 1975)]

•Proposed Effluent Guidelines,
Performance and Pretreatment
Standards for Pulp, Paper, and
Paperboard Builders' Paper and
Board Mills
REFERENCE

45 FR 912
45 FR 923
45 FR ^9450
45 FR 63223
45 73. 75694
45 FR 32253
46 FR 1420

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                         2-34



                       EXHIBIT 2-4

      TWENTY-ONE PRIORITY INDUSTRIES IDENTIFIED IN
                1977 SETTLEMENT AGREEMENT



Timber products processing

Steam electric power plants

Leather tanning and finishing

Iron and steel manufacturing

Petroleum refining

Inorganic chemicals manufacturing

Paving and roofing materials

Paint and ink formulation and printing

Soap and detergent manufacturing

Auto and other laundries

Plastic and synthetic materials manufacturing  •

Textile mills

Organic chemicals manufacturing

Nonferrous metals manufacturing

Pulp and paperboard mills and converted paper products

Rubber processing

Miscellaneous chemicals

Machinery and mechanical products

Electroplating

Ore mining and dressing

Coal mining

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                                   2-35
STANDARD-SETTING METHODOLOGY

     The preambles to the eight proposed regulations set forth the process by
which the Agency evaluates pollution control techniques as fulfilling a
certain level of technology.  This process, in broad terms, entails six basic
steps.

      (1)  Data on the industry to be regulated was gathered, including number
of firms; size, age, physical configuration and location of plants; control
equipment in use in various types of plants; and economic data on the indus-
try.  Based on these data, industries were divided into sub-categories
reflecting key shared characteristics, and regulations were established for
each sub-category.

      (2)  Effluent specimens from a sample of firms were taken and analysed
for pollutants.  These samples were compared to concentrations from intake
sources to determine the contribution of the industrial process to wastewater
concentrations.

      (3)  Because the 65 pollutants and classes of pollutants included thou-
sands of specific substances, EPA selected 129 pollutants for study in these
industry rulemakings.  The criteria for selection of the 129 included fre-
quency of occurrence in water, chemical stability and structure, amount of the
chemical produced, and availability of chemical standards for measurement.
These pollutants are discussed further below.

      (4)  The wastewater samples collected from each of the industry sources
were then analyzed for the presence of any of the 129 specified polutants,
using analytical methods identified by EPA scientists who considered "their
sensitivity, laboratory availability, costs, applicability to diverse waste
streams from numerous industries, and potential for implementation within the
statutory and court-ordered time constraints. . .  . "2

      (5)  Effluent limitations and performance standards were calculated from
the assembled data on wastewater concentrations, industry profiles, and the
cost  and availability of various control technologies.  This process was
repeated for each of the standards and guidelines required by the Act.

      (6)  EPA's criteria documents for the 129 pollutants in question served
as the basis for establishing "safe" concentrations.  Effluent limitations are
calculated against, these safe concentration, using the assembled data on
wastewater concentrations, industry profiles, and cost and availability of
various control technologies.
     2This explanation is included in the Preambles to all of the proposed
regulations.  See, e.g., 44 FS 38746 (proposed regulations for leather tanning
industry).

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                                   2-36
EFFLUENT LIMITATIONS FOR CONVENTIONAL POLLUTANTS

     Section 304(a)(4), included in the 1977 Amendments,  identifies conven-
tional pollutants "including but not limited to pollutants classified as
biological oxygen demanding, suspended solids, fecal colifona, and pH."
Section 301 calls for the achievement of effluent limitations for this
category of pollutants through "application of the best conventional pollutant
control technology."  Factors to be taken into account when determining the
best conventional control technology (3CT) "include consideration of the
reasonableness of the relationship between the costs of attaining a reduction
in effluents and the effluent reduction benefits derived, and the comparison
of the cost and level of reduction of such pollutants from the discharge..."
(Section 304(b)(4)(B)).

     The 3CT requirement replaces the 1974 mandate for installing the "best
available technology economically achievable" to control conventional pollu-
tants.  Again, this change in required control technology reflects the focus
cf the 1977 Amendments, which shifted the emphasis from control of "classical"
(conventional) pollutants to control of toxic substances.

     Conventional pollutants are nowhere defined explicitly in the CVA:  EPA
was therefore given broad discretion in determining the criteria it would
employ.  EPA issued a proposal for the "Identification of Conventional
Pollutants" on July 28, 1973 [43 FR 32S57] and a final rule was published July
30, 1979 [44 FR 44501].  The proposed rule outlined the criteria used to
identify substances as conventional pollutants (or pollution parameters) and
listed chemical oxygen demand (COD), phosphorus, and oil and grease as
possible additions to the conventional pollutants set forth in the CVA.  Four
criteria were examined, two of which were ultimately selected:

          •    The major consideration in the selection process
               was the "environmental effects" of classes of
               pollutants.  EPA reviewed the  legislative history of
               the Act, which indicated that  conventional pollutants
               were generally "naturally occurring, biodegradable,
               oxygen-demanding materials, and solids [sic] and
               which have similar characteristics to naturally
               occurring biodegradable substances."  Since these
               characteristics impact water quality and aquatic
               life, they were therefore deemed an appropriate
               selection criterion.

          •    The second criterion established by the Agency was
               the designation of those pollutants which
               traditionally have been the primary focus of
               wastewater control.  This action was supported by the
               Act's specification of pH and  fecal coliform, both of
               which have been widely-used indicators of overall
               water quality.

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                                   2-37
          •     Because the cost and level of reduction of
               conventional pollutants from the discharge of PGTVS
               is one factor used to establish the "reasonableness"
               of BCT limitations, EPA considered using treatabiiity
               by a PQTV as a selection criterion.  The concept of
               secondary treatment was nowhere identified by
               Congress as a requirament in defining the
               reasonableness test, however, and EPA therefore
               determined that it should not be included as a
               necessary criterion for selection.

          •     The fourth criterion considered was that
               conventional pollutants be only those not identified
               as toxic.  The Agency decided, however, that toxic
               properties were not sufficient to preclude a
               substance from identification as a conventional
               pollutant.  Moreover, EPA believes it has been given
               the flexibility to weigh a substance's toxic and
               conventional properties and assign that substance to
             '  the list it deems more appropriate.  The major impact
               of assigning a pollutant to one or the other list is
               that conventional pollutants require BCT limitations,
               while toxic pollutants must meet BAT; the level of
               control for a conventional pollutant may therefore be
               less stringent.

     The conventional pollutants required by the CWA and EPA's final additions
to this list are:

          •     Biochemical oxygen demand (BOD)  BOD is a
               pollution parameter which is often used as an
               indicator of the amount of organic chemicals present
               in the water sample.  It is a standard laboratory
               test used to determine waste loadings to wastewatar
               treatment plants and evaluate the efficiency of
               treatment systems.

          •     Total suspended solids (7SS) is a second
               laboratory measure of the organic and inorganic
               particulata matter present in wastewater.

          •     Fecal colifsrm bacteria are "recognized
               universally as indicators of sanitary water
               quality,"1 as they indicate the potential presence
               of pathogenic intestinal organisms.
    J43 TS. 32857, July 23, 1978 ("Designations and Proposed Additions to
'Conventional' Pollutants List").

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                                   2-38
          •    The oH test measures acidity and alkalinity;
               changes in pH can effect the toxicity and solubility
               of many chemical compounds, including metals and
               metallic salts.

          •    Oil and grease is defined by the measurement
               method which identifies many similar "oil" substances
               of petroleum, animal and vegetable origin, all of
               which are oxygen-demanding.

     Two other pollutant parameters, phosphorus and chemical oxygen demand
(COD) were proposed for addition to the list but deleted from the final
rule.1*  The most recent attempt to amend the list of conventional pollutants
was a petition by the American Iron and Steel Institute to add
ammonia and sulfide to the list.  The petition was denied by EPA on December
1, 1980 [45 FR 79694] on the grounds that, while both substances are oxygen-
demanding, naturally occurring and biodegradable, they have not traditionally
been the primary focus of wastewater control, and thus did not meet one of  the
necessary criteria.

     A review of the nine proposed regulations indicates that the major factor
on which the agency relied in selecting BCT was that of "cost reasonableness"
as calculated by the "BCT test" promulgated in August, 1979.5  The BCT test
compares the cost for a given technology to remove a pound of conventional
pollutants to the cost incurred by a POTW for removing a pound of the same
substance.  If the POTW cost is higher, then the technology is considered to
have passed the BCT test, i.e., to incur a "reasonable" cost.

     The major advantage to the BCT regulations, according to E?A,S is that
they establish a uniform measure of reasonableness for all industries
throughout the county, and allocate a greater proportion of the total costs
for control of conventional pollutants t,o the industries which face the lowest
marginal cost.

     In none of the regulations is any reference made to the health effects of
various levels of control, only to whether the technology fits the
requirements set forth in the CWA.
     "44 FR 44501, July 30,  1979  ("Identification of Conventional Pollu-
tants", Final Rule).  COD was deleted because not all the substances measured
by the test deplete oxygen which  would otherwise be available  for organisms.
Phosphorus was deleted because it presents an environmental problem in  only
limited geographical  areas,  and thus did not justify the setting of a national
standard.

     S44 FR 50732  (August 29, 1979).

     *44 FR 50733.

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                                   2-39
EFFLUENT LIMITATIONS FOR TOXIC POLLUTANTS

     The 1977 Amendments shifted the focus of EPA's water pollution control
strategy to the eventual elimination of all dischargas and, in particular,
discharges of toxic pollutants.  To achieve this goal, the Agency is relying
on the installation of BAT in regulated industries as required by Sections
301(b)(2)(C) through (?).

     The pollutants are the 129 specific substances listed in Exhibit 2-5,
selected by EPA from the list of 65 priority pollutants and classes of
pollutants.  Wastewater samples are analyzed for the presence of these
substances at identifiable and measurable concentrations.

     Having identified the specific pollutants discharged by the industry in
question, EPA must select an effluent limitation which reflects SAT for that
industry (or industry sub-category).  According to EPA, its assessment "con-
siders" costs, but does not require a balancing of costs against effluent
reduction benefits 7.  In developing the proposed BAT, however, EPA has
given substantial weight to the reasonableness of costs.  The Agency has
considered the volume and nature of discharges, the volume and nature of
discharges expected after application of BAT, the general environmental
effects of the pollutants, and the costs and economic impacts of the required
pollution control levels.1

     The reasons for selecting a technology as BAT for a particular industry
vary among the proposed regulations, but all refer to the "cost reasonable-
ness" criterion; e.g., "provides significant removal of the toxic pollutants
of concern in this industry";* "provides substantial reductions of toxic
pollutants (and costs are reasonable)";1" "best supported by available data
and affords further reduction in total pollutant discharges through the use o:
proven technology;"11 or can "completely eliminate the discharge of toxic
pollutants. . . without creating unacceptable economic or nonwater quality
impacts.";2
      7See Weyerhauser v. Costle, 11 ESC 2149 (D.D.C. 1978)

      "These same factors ara listed in the Preambles to all nine proposed
regulations.  See, e.g., 44 FR 38754 (Proposed regulations for leather tanning
facilities).

      '44 FR 38755, July 2, 1979 (Proposed regulations for leather tanning
and finishing facilities).
     19
       44 FR 62214, October 29, 1979 (Proposed regulations for textile mills)
     1144 FR 75934, December 21, 1979 (Proposed regulations for petroleum
refineries).

     1245 FR 933, January 3, 1980 (Proposed regulations for ink formulating
facilities).

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                                           2-40
                                      EXHIBIT  2-5
                  TOXIC POLLUTANTS  SELECTED  FOR  STUDY AND
               REGULATION  UNDER  TOXIC EFFLUENT  GUIDELINES
acroimn
aery Ion: tnie
1.2.4-tnchiorobenzene
1.2-dichioroetSan>
hexachinroetnane
1.1 -dichloroethane
l.U-mcnlcroethane
cnioroo thane
bis (chloroethyl) eihei
bis (2-cnioroethyll ether
2-chloroethly vinly ether
2-cbloronaohthaieor
para-chluro-meia-cresol
2-chlorophenol
1.3-dichiorobenienf
1.1-dichloroethylene
1.2-dichloropropane
1.3--reuc (benzn(b)pjTene)
3.4-benzonuoranihene (b*nzo(b)Quoranthene|
1 1 . U-Derxiofiuoramncne
  { benzol k )nuoranthen«)
aeenHphtnyiene
'..li-oenzoperyicnp fbenzoigni)perylene)
    .
  fdibenzofaJc)an:hraeene|
inoeno (:^J-ca) pyrene (IJ-o-phenyiene
  pyfene)
tncnioroethylene
vinyl c-itonoe icnioroethylene]
aianr.
dieirinn
chiorcane
4.4 -DDT
4.4--DDE (p.p'-DDXl
4.4--DDD (p.p'-7D£)
B-endosu!.'aa
t>«ndosu!rar.
endosulfan lulfate
enonn
encnn aldehyde
heptachior
heptaehior cpoxide
• -BHC
b-BHC
r-BHC (Undine)
s-BHC
PCS-1242 (Arochlor 1242)
PC3-12M (Arocnior 1254)
PC3-12rl (AroehlorlZZl)
PCS-1232 (Arocnior 12221
PCS-1248 lArochlor 1248)
PCB-12SO (Arochlor 1260|
PCB-1016 (A.-schior 1316)
loxaphene
2.3.7.8-tetrachlorodibcnzo-p-dioxin (TC3D)
/njni-l-2-dichloroethene
1.1.1-tnchloroethane
tetrachloramethane (carbon tetrac.iior.de]
1.1^2-teirachioroethcne
1.1^2-tetrachloroethane
chiorobenzene
hexaciior u oenzcne
/j-nitrosodjpnenyiamme
1.2-diphenylhydra2ine
benzidme
3.3'-dichlorobenzidine
nitrobenzene
isophoronc
Quorene
nuoranthene
pyrene
dicthyl phthalate
di-n-butyl pnthabte
cnryscne
2.4-
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                                   2-41
    The selection of BAT is considerably more discretionary than is the
designation of BCT, which relies on a well-defined and fairly unambiguous cost
comparison "test."  To determine BAT, EPA must simply review the technological
options and develop a justification of its final choice (strong enough to
withstand legal challenge) as fulfilling the broad statutory requirements of
Section 301(b)(2).

NEW SOURCE PERFORMANCE STANDARDS (NSPS)

    Section 306 defines two requirements for establishing "national standards
of performance" for new sources13 in a specified list of industries (see
Exhibit 2-6).  The basis for new source performance standards (NSPS) under
Section 306 of the Act is the best available demonstrated technology.
According to EPA, new plants have the opportunity to design the best and cost
efficient. .  .  processes and wastewater treatment technologies, and therefore,
Congress directed the Agency to consider the best demonstrated process
changes, in-plant controls, and end-of-pipe treatment technologies which
reduce pollution to the maximum extant feasible.

    NSPS requires technologies which reduce effluents to the maximum extant
feasible, and EPA appears to have defined feasible as taking costs and ether
factors into consideration.  A review of the proposed regulations indicates
that certain technologies were rejected because they were "too expensive and
sophisticated for use in this industry";1* did not "address the removal of
toxic metal pollutants" or "because of the lower removal rate and higher cost
compared to another option",1S or because of "practical considerations and
high costs".16

    Where feasible, NSPS are to be set at zero discharge, taking into account
possible non-water quality impacts of such standards (i.e., zero discharge
into bodies of water may result in an increase in sludge production, which EPA
might consider unacceptable).  Of the nine proposed standards three (timber
and ink and paint formulating) have recommended zero discharge as NSPS.
    llNew source is defined as "any source, the construction of which is
commenced after the publication of proposed regulations prescribing a standard
of performance under this section which will be applicable to such source, if
such standard is thereafter promulgated in accordance with this section."  See
40 CFR 403.3(j).

    1444 ?R 38756, July 2, 1979 (Proposed regulations for leather tanning
and finishing facilities).

    1S44 FR 63717, November 29, 1979 (Proposed regulations for gum and wood
chemical manufacturers).

   " 1S45 FR 63236, October 14, I960 (Proposed regulations for steam electric
power plants).

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                     2-42



                   EXHIBIT 2-6

      CATEGORIES OF SOLUCES REQUIRING NS?S
pulp and paper mills
paperboard, builders paper and board mills
meat product and rendering processing
dairy product processing
grain mills
canned and preserved fruits and vegetables processing
sugar processing
textile mills
cement manufacturing
feedlots
electroplating
organic chemicals manufacturing
inorganic chemicals manufacturing
plastic and synthetic materials manufacturing
soap and detergent manufacturing
fertilizer manufacturing
petroleum refining
iron and steel manufacturing
nonferrous metals manufacturing
phosphate manufacturing
steam electric powerplants
ferroalloy manufacturing
leather tanning and finishing
glass and asbestos manufacturing
rubber processing
timber products processing

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                                   2-43
PRETREATMEMT STANDARDS FOR EXISTING AND NEW INDIRECT DISCHARGERS

     Sections 307 (b) and (c) require EPA to promulgate pretreatment standards
for both existing and new sources which are indirect dischargers  (i.e.,
sources whose wastewater is treated by a POTW)•   In either case,  the following
pollutants are prohibited from being introduced into a POTV:

          (1)  Pollutants which create fire and explosion hazards in
               the POTV;

          (2)  Pollutants which will cause corrosive structural
               damage to the PQTW, but in no case discharges with pH
               lower than 5.0, unless the works is specifically
               designed to accommodate such discharges;

          (3)  Solid or viscous pollutants in amounts which will
               cause obstruction to the flow in sewers, or other
               interference with the operation of the POTV;

          (4)  Any pollutant, including oxygen demanding pollutants
               (BOD, etc.), released in a discharge of such volume
               or strength as to cause interference in the POTV.

          (5)  Heat in amounts which will inhibit biological
               activity in the PQTW resulting in interference but in
               no case heat in such quantities that the temperature
               at the treatment works influent exceeds 4Q°C (104°F)
               unless the works is designed to accomodate such
               heat.  [40 CFR Part 403.6]


     Pretreatment standards for both existing sources  (PSES) and  new sources
(PSNS) were designed "to prevent the discharge of pollutants that pass
through, interfere with, or are otherwise incompatible with the operation of
POTWs."17  The 1977 Amendments additionally require pretreataent  for
pollutants such as heavy metals, which might limit POT* sludge management
alternatives.  Of concern here appears to be potential beneficial uses of
sludge, e.g., as fertilizer for agricultural lands.  Pollutants which would
make the sludges from POTWs unfit for such beneficial uses are to be
controlled at the source.

     As interpreted by EPA, the legislative history of the 1977 Act indicated
that pretreatment standards were to be technology-based and analogous to the
best available technology for removal of toxic pollutants.11  As  with the
     1 7
       Sections 307(b) and (c).
     11This interpretation is included in the Preambles to each of the
proposed regulations.  See, e.g., 44 TS. 38746 (Proposed regulations  fo:
leather tanning facilities).

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other guidelines and standards, the methodology used to set PSES  (and PSN'S)
was to identify several technological options and to select the one which
seemed best to fit the specified criteria.  The justifications for particular
choices referred less to the cost factor than did either the BCT  or BAT
regulations, although consideration of extreme costs was a factor in rejecting
certain options.  The following excerpts from the Preambles to some of the
proposed regulations provide an indication of the types of decision criteria
employed:

          •    [This option] ensures the removal of approximately
               36% of the organic and 55% of the metal toxic
               pollutants and allows PQTWs more flexibility in
               sludge disposal.  [A second option] was rejected
               because it provides no control of toxic pollutants or
               protection against the contamination of PQTW
               sludge.1'

          •    [The option selected provides] complete elimination
               of discharges of pollutants as the basis for PSES
               . . .  Not only will this option prevent the
               discharge of high concentrations of toxic solvents to
               PQTWs, but solvents also have an economic value and
               can either be sold to scavengers or reclaimed on-site
               and re-used.20

          •    [The option chosen] will insure removal of the bulk
               of trivalent chromium and other heavy metals at the
               industrial site and give PQTWs more flexibility in
               sludge disposal.  [Another option was rejected]
               primarily because the projected economic impact was
               high and because space and land constraints of
               existing plants would not permit widespread
               installation of these technologies.21

    Such comments are representative of the arguments made in support: of a
selected rechnological option and suggest what cost reasonableness is less  of
a factor in setting pretreatment standards for existing sources than for
setting either BAT or BCT.

    Pretreatment standards for new sources (PSNS), required under Section
307(c), are to be promulgated concurrently with NSPS.  EPA's strategy toward
    1S44 T&. 62204, October 29, 1979  (Proposed regulations for gum  and wood
chemicals) .

    2C45 YR 928, January 3, 1980  (Proposed regulations  for  ink  formulating).
         FH 38746, July 7,  1979  (Proposed  regulations  for  leather  tanning
and finishing facilities).

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                                   2-45
regulating new indirect discharges has been to require such sources to meet
the most stringent of standards, with the justification that:

          New indirect dischargers, like new direct dischargers,
          have the opportunity to incorporate the best available
          demonstrated technologies including process changes,
          in-plant control measures, and end-of-pipe treatment, and
          to use plant site selection to ensure adequate treatment
          system installation.22

In other words, PSNS are to be the technological equivalent, for indirect dis-
chargers ,  of NSPS for direct dischargers.

     As was the case with PSES, the explanations of the PSNS selection process
indicate that cost, while a factor, was not the overriding consideration in
making a determination:

          •    [This option was selected]  because it ensures the
               removal of approximately 60% of the significant
               organic and 50% of the significant metallic toxic
               pollutants and allows POTVs more flexibility in
               sludge disposal.  In addition, the technology further
               increases protection against the discharge of high
               levels of COD and color. .  .  . 23

          •    [Zero discharge was selected because] the Agency's
               economic impact analysis. . .  concluded that the cost
               of designing and installing the proper systems needed
               to achieve the no discharge status would not hinder
               the addition of new capacity.1"

          •    [PSNS was set equal to PSES because this option]
               will provide the removal of the [bulk of] heavy
               metals at the source for greater efficiency of
               removal at less cost.2*
     22This justification is presented in each of the Preambles to the
proposed regulations.  See, e.g., 44 FR 38746 (Proposed regulations for
leather tanning and finishing facilities).

     2344 FR 62204, October 29, 1979 (Proposed regulations for textile
mills).

     2U44 FR 62310, October 31, 1979 (Proposed regulations for timber
processors).

     2SFR 68710, November 29, 1979  (Proposed regulations for gum and wood
chemicals).

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                                   2-46
EPA's strategy seems to have been to consider first the level of control pro-
vided by each of the options, and only to consider costs where they appear to
be extreme or unwarranted.

     Although a justification has been made by EPA for expecting more strin-
gent controls of new sources, five of the nine proposed standards have set
PSES equal to PSNS.  Of these, two (paint and ink formulating) set both at
zero discharge.  Of the four which propose differential standards, PSNS is the
more stringent of the two and, for timber processing plants, is set at zero
discharge as well.

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                                   2-47
            TOXIC POLLUTANT EFFLUENT STANDARDS--REGULATORY REVIEW
     This section reviews the Toxic Pollutant Effluent Standards, 4Q C?H 129,
promulgated under Section 307 of the Clean Water Act (or CWA),  including-

          (1)  the criteria used by EPA to list chemical substances
               as toxic pollutants under Section 307;

          (2)  the chemical substances designated as toxic
               pollutants;

          (3)  the criteria used by EPA to establish effluent
               standards; and

          (4)  the types of effluent standards developed for toxic
               pollutants.

     Exhibit 2-7, Regulatory Chronology, summarizes the regulatory actions
reviewed.

NINE TOXIC POLLUTANTS:  DESIGNATION AND PROPOSE3 EFFLUENT STANDARDS

     The 1973 Amendments to the Clean Water Act instructed EPA to publish "a
list which includes any toxic pollutant1 or combination of such pollutants
for which an effluent standard .  . .  will be established. .  ." (Section
307(a)(l)).   To list pollutants as toxic, EPA must consider:

          •     the toxicity, persistence and degradability of the
               pollutant,

          •     the usual or potential presence of the affected
               organisms in any waters (i.e., are affected organisms
               found or in the future will they be found in waters
               where discharges may occur?),

          •     the importance of the affected organisms, and
    1The term, "toxic pollutant" is defined in Section 502(13) of the Act
as "those pollutants or combinations of pollutants, including disease causing
agents, which after discharge and upon exposure, ingestion, inhalation or
assimilation into any organism, either directly from the environment or in-
directly by ingestion through food chains will, on the basis of information
available to the Administrator, cause death, disease, behavioral abnormali-
ties,  cancer, genetic mutations, physiological malfunctions (including mal-
functions in reproduction) or physical deformations in such organisms or thai:
offspring."

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                                    2-48
                                  EXHIBIT 2-7

          SECTION 307 OF THE CLEAN WATER ACT:  REGULATORY CHRONOLOGY
    DATE
     EPA REGULATORY ACTION
FEDERAL REGISTER
    CITATION
 September 7,  1973


'October 26,  1973


 December 27,  1973


 April,  May 1974


 June 10, 1976



 June 30, 1976


 July 23, 1976


 January 12,  1977



 February 2,  1977


 January 31,  1978

 March 15, 1979




 March '27, 1979


 July 30, 1979
Published List .of Nine Toxic            38 FR 24342
Pollutants

Proposed Water Quality Criteria         38 FR 29646
Documents

Proposed Effluent Standards for Nine    38 FR 35388
Listed Toxic Pollutants

Evidentiary Hearing on Proposed         	
Effluent Standards

Proposed Revised Effluent Standards     41 FR 23576
for Aldrin/Dieldrin, DDT, Endrin, and
Toxaphene

Proposed Revised Effluent Standards     41 FR 27012
for Benzidine

Proposed Revised Effluent Standards     41 FR 30468
for PCBs

Promulgated Effluent Standards for      42 t"R 2588,
Aldrin/Dieldrin, DDT, Endrin,           2617
Toxaphene, and Benzidine

Promulgated Effluent Standards for      42 F[R 6532
PCBs

Published List of 65 Toxic Pollutants   43 FR 4108

(1)  Published Water Quality Criteria   44 FR 15930
     for 65 Toxic Pollutants
(2)  Published Guidelines for Deriving  44 FR 15926
     Water Quality  Criteria.

Issued Guidance on  Revisions of         44 FR 18279
Toxic Pollutant List

Amended General Provisions for          44 FR 44502
Effluent Guidelines and Standards,
40 CFR 401.15  to Include List of 65
Toxic Pollutants

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                                   2-49
                           EXHIBIT 2-7 (continued)

         SECTION 307 OF THE GLEAN WATES ACT:  REGULATORY CHRONOLOGY
   DATE
EPA REGULATORY ACTION
                                      FEDERAL REGISTER
                                          CITATION
October 17, 1979



January 3, 1980


April 7, 1980




July 9, 1980


September 15, 1980



November 28, 1980


December 1, 1980


January 3, 1981
                                         599^3
Denied Dow Chemical Company's Peti-     45 	
tion to Remove Aromatic Haloethers
from the Toxic Pollutant List

Proposed Addition of Ammonia to Toxic   £-5 FR 303
Pollutant List

Denied Dow Chemical Company's Peti-     io FR 22512
tion to Remove 1,1,1-Trichloroethane
and Methylene Chloride from the
Toxic Pollutant List

Proposed Removal of F-ll and F-12       ^5 FR i61C3
from the Toxic Pollutant List

Proposed Removal of 3is-(chloro-        ^5 FR 60942
methyl) Ether (BCME) from the
Toxic Pollutant List

New water quality critiera for 64       i5 FR 79318
toxic pollutants

Withdrew Proposal to Add Ammonia        45 FR 79692
to Toxic Pollutant List

(1)  Removed F-ll and F-12 From the     46 FR 2266
     Toxic Pollutant List

(2)  Denied Dow Chemical Company's      46 FR 2267
     Petition to Remove Phenol,
     2,4-Dichlorophenol,
     2,4,5-Trichloropheno1,
     Pentac'alorophenol, and
     Ethylbenzene from the Toxic
     Pollutant List

(3)  Proposed Denial of Dow's           46 FR 2273
     Petition to Remove Mono-
     chlorophenyl Phenyl Ether
     (CIDPO) from The Toxic
     Pollutant List

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                                   2-50
          •    the nature and extent of the effect of the toxic
               pollutant on such organisms.2

    EPA designated nine pollutants as toxic*substances on September ", 1973
because they met the following criteria:3

          (1)  Data from laboratory or field studies indicated that
               the pollutant could, if discharged into water,
               constitute a serious environmental threat.

          (2)  The pollutant was discharged, or had the potential to
               be discharged, from point sources and constituted a
               very serious environmental threat.

          (3)  Data were available to establish effluent standards
               which met the requirements of the Act.

          (4)  Standard setting under Section 307(a) was
               "appropriate," and was "necessary."

Exhibit 2-8 presents a detailed explanation of these criteria.  Exhibit 2-9
lists the nine designated toxic pollutants  and identifies the types of effects
which led EPA to conclude that each chemical posed a serious environmental
threat (i.e., met the requirements of Criterion (1) above).

     On December 27, 1973, EPA proposed effluent standards for each of the
nine listed toxic pollutants (38 FR 35388).  EPA identified the following
four factors as instrumental in setting the standards:

          (1)  toxicological data,

          (2)  hydrodynamic data,

          (3)  ample margins of safety, and

          (4)  calculations of acute and-chronic toxicity levels.

The primary sources for toxicological and hydrodynamic data were Water Quality
Criteria Documents proposed in October 1973.  Because there was no proposed
water quality criteria document for benzidine from which toxicological and
    2Section 307(a)(1) of the Clean Water Act.

    'Preamble to the List of Toxic Pollutants,  38 FR  24342,  September  7,
 1973.

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                                   2-51
                                 EXHIBIT 2-3


       DESIGNATION C3ITZ5IA FOR THE MINE TOXIC POLLUTANTS (1973)a/


Criterion (1):  Toxicological Effects Used to Indicate an Environmental Threat

     (A)  Bioaecumulation:  Data was reviewed to determine if a. substance or
          its chemical or biological transformation product was bioaccumulatad
          through an aquatic mechanism and resulted in reproductive impairment
          in any important species or resulted in concentrations in food
          sources in excess of applicable Federally established tolerance
          levels.

     (3)  Carcinogenic, Mutagenic and Teratogenic Effects:  Chemicals  likely
          to have these effects in humans were evaluated for chemical,
          biological, and physical stability in water.

     (C)  High Acute Toxieity:

          (1)  Chemicals classified as "highly toxic" by the Environmental
               Protection Agency under the Federal Insecticide, Fungicide, and
               Rodenticide Act (40 CrU 162.3) and by the Food and Drug
               Administration testing procedures (21 CFR 191.10) were
               considered for designation.

          (2)  Substances proposed to be classified as "highly toxic"
               according to the National Academy of Sciences water pollution
               ranking system also were considered for inclusion in the list.

Criterion (21:  Factors to Assess the Seriousness of Discharges

     Seriousness of discharges data included such characteristics of the
pollutant as:

         (A)  the nature and extent of toxic effects,

         (3)  the extent to which discharges have been identified,
              and

         (C)  the production, distribution, and use pattern.

    EPA specified that seriousness of discharges data must be from "well
documented field studies showing damage to important organisms from discharges
of the compound into waters, or technically sufficient to show the material
has the potential to be environmentally harmful after being discharged from
point sources to the water." (38 FS 24342)

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                                   2-52



                           EXHIBIT 2-8 (continued)


       DESIGNATION CRITERIA FOR THE NINE TOXIC POLLUTANTS (1973)a/


Criterion (3):  Types of Data Necessary to Establish Effluent Standards Under
                the Clean Water Act

     The following were identified by EPA as representative of the categories
of data useful in standard setting:

     (A)  Toxicity to man and other organisms;

     (B)  Carcinogenicity, mutagenicity, and teratogenicity data;

     (C)  Transport paths of the material in the environment;

     (D)  Bioaccumulation and bioconcentration;

     (E)  Chemical, physical, and biological transformations in the environ-
          ment;

     (F)  Reliability and accuracy of analytical procedures;

     (G)  Chemical characteristics;

     CH)  Production and industrial or commercial utilization;

     (I)  Sources of pollutant discharges to water;

     (J)  Environmental incidents attributable to the material  (fish kills,
          etc.);

     (X)  Presence of the material in the environment, residue  levels  in
          various organisms, ambient concentrations in rivers,  lakes,  etc.;

     (L)  State and Federal regulatory requirements concerning  the material;

     (M)  Classes and characteristics of waters into which the  material is
          discharged.

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                                   2-53
                           EXHIBIT 2-3 (continued)


       DESIGNATION CRITERIA FOR THE NI.NS TOXIC POLLUTANTS (1973)a/


Criterion i» :   Environmental Effects of Available Control Measuras

     EPA evaluated the prospective timing and effectiveness of abatement
actions under other provisions of the Act to ensure that other control
measures were not commensurate with the nature and seriousness of the problems
identified by the above criteria.  In addition, the Agency considered the
environmental effects of substitute products and.the possible effects of
pollutants on ground water and other environmental media.  In this way. EPA
determined that regulation of the nine pollutants under Secticn 307(a) was
"appropriate" and "necessary."
1973.
     -'Preamble to the List of Toxic Pollutants, 38 FS 243«.2, September 7,

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2-54


















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-------
                                   2-55
hydrodynamic data could be examined, EPA derived effluent standards for benzi-
dine by extrapolating laboratory animal data to humans.1'

     To provide an ample margin of safety for acute toxic effects, EPA chose a
concentration limit of one tenth the 96-hour LC50 for each chemical.5  EPA
presented no rationale for selecting the particular one tenth factor.

     To protect against chronic toxicity, EPA limited the total weight of a
pollutant which could be discharged into receiving waters of a given size.  To
provide an ample margin of safety, EPA reduced the allowable weight of a
chemical discharged per unit of water flow by safety factors.  These safety
factors were designed to compensate for non-point sources of the pollutant,
multiple discharges in a. small area, industrial growth, and the difference in
water storage times among lakes, estuaries, streams, and coastal waters.'

     The 1973 proposed standards were developed under time constraints imposed
by a court order in response to litigation commenced by the Natural Resources
Defense Council (NRDC v. Fri, Civ. Action No. 849-73 (D.D.C. June 13, 1973,
as modified)).  As a result, EPA did not have sufficient time to develop data
in certain areas.   A thirty-day evidentiary hearing was held en the proposed
standards in April and May 1974 where industry representatives introduced
evidence of data gaps in EPA's standard setting process concerning:

          (1)  analytical and monitoring technology,

          (2)  hydrological assumptions,

          (3)  availability of control technology,

          (4)  economic impacts, and  .

          (5)  identity of point source discharges.
     "Water Quality Criteria Documents were proposed by EPA on October 26,
1973 (38 FR 29646) pursuant to Section 304(a) of the Clean Vater Act.  Water
Quality Criteria Documents are not to be confused with the Drinking Watar
Quality Criteria which are separate documents.

     'The 96-hour LC50 is that concentration derived from laboratory tests
in which 50 percent of a group of test organisms survive after 96 hours of
continuous exposure to a pollutant.  The 96-hour LCSO is a common acute
toxicity test.

     'Proposed Toxic Pollutant Effluent Standards, 38 F3 35388, December
27, 1973."

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                                   2-ib
     EPA concluded that the data gaps in the hearing record meant that EPA
could not fully substantiate the proposed standards at that time.  As a
result, the Agency decided to gather additional information and repropose new
standards at a later date.7

SIX TOXIC POLLUTANTS:  1975 REPRQPOSED EFFLUENT STANDARDS

     EPA reproposed effluent standards in 1976 for the following six chemicals
which were among the nine toxic pollutants for which standards were initially
proposed in 1973:

          (1)  Aldrin/Dieldrin'

          (2)  DDT

          (3)  Endrin

          (4)  Toxaphene

          (5)  Benzidine

          (6)  Polychlorinated Biphenyis (PCBs)

Subsequently, Toxic Pollutant Effluent Standards, 40 CFR 129 were promulgated
by EPA for these six chemicals.'  Exhibit 2-10 displays the six toxic, pollu-
tants and their definitions as they appear in Part 129.4 of the regulations.

     EPA did not repropose effluent standards for all nine toxic pollutants
because the Agency decided that concurrent action on a more limited number of
standards would result in higher quality rulemakings in each case.  According
to EPA, to propose and promulgate nine effluent standards simultaneously posed
"unwarranted and intolerable burdens" on the objecting parties and the Agency
      'Preamble to Proposed Toxic Pollutant Effluent Standards, 41 FR
22577, June 10, 1976.

      'Aldrin and Dleldrin are regulated as a single entity because aldrin
is rapidly transformed to dieldrin in the environment.

      'Effluent standards for Aldrin/Dieldrin, DDT, Endrin, Toxaphene, and
Benzidine were promulgated on January 12, 1977 (42 FR 2588,2617).  PCS's
effluent standards were promulgated on February 2, 1977  (42 FR 6532).  The
six effluent standards are applicable to classes or categories of point
sources only if the standards "impose more stringent requirements" on  the
point sources than the (BAT) effluent limitations promulgated under Sections
301(b)(2) and 304(b)(2) of the CWA.

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                              2-57



                            EXHIBIT 2-10

          SIX 1976 TOXIC POLLUTANTS AND THEIR DEFINITIONS
(1)  Aldrin/Dieldrin:   "'Aldrin' means the compound aldrin as identified
     by the chemical name, l,2,3,4,10,10-aexacaloro-l,4,4a,5,3,3a-hexa-
     hydro-l,4-endo-5,8-exo-dimethanonaphthalene."

     "Dieldrin means the compound dieldrin as identified by che cheaical
     name 1,2,3,4,10,10-hexachloro-6,7-epoxy-l,4,4a,5,6,7,8,3a-octahydro-
     l,4,-endo-5, 3-exo-dimethanonaphthalene."

(2)  DDT:  "'DDT'  means the compounds DDT, ODD,  and DDE as identifiad by
     the chemical  names:  (DDT)-1,1,l-trichloro-2,2-bis (p-chlorophenyl)
     ethane and some o, p'-isomers; (DDD) or (TDE)-l,l-dichloro-2,2-bis
     Cp-chlorophenyl)  ethane and some o, p'-isomers;
     (DDE)-l,l-dichloro-2,2-bis (p-chlorophenyl) ethylene."

(3)  Endrin:   "'Endrin' means the compound endrin as identifiad by the
     chemical name 1,2,3 ,4,10, iO-hexachlcro-6 , 7-epoxy-i,4, --a.,5 ,6 ,7 , 3 , 3a-
     Octahydrol,4-endo-5,8-endo-dimethanonaphthalene."

(4)  Toxaohene:  "'Toxaphene' means a material consisting of technical
     grade chlorinated camphene having the approximate foraula of
     C.-H,nC,a and normally containing 67-69 percent chlorine bv
      iu lu io
     weight."

(5)  Benzidine:  '"Benzidine" means the compound benzidine and its sal~s
     as identified by the chemical name 4,4'-di-aminobiphenyl."

(6)  Polychlorinated Biphenyls (?C3s):  "Polychlorinated biphenyls
     (PC3s) means  a mixture of compounds composed of the biphenyl
     molecule which has been chlorinated to varying degrees."
Source:   40 CrU 129.

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                                   2-58
(41 FJR 22579) ..  Instead, EPA proposed and promulgated "responsible and defen-
sible standards for the six chemicals with adequate data bases"."10

Statutory Criteria for Designation and 'Standards

     At the tiae the six effluent standards were promulgated, Section 307(a)(2)
of the Act (as amended in 1972) required EPA to consider "the toxicity of the
pollutant, its persistence, degradability, the usual or potential presence of
the affected organisms in any waters, the importance of the affected organisms
and the nature and extent of the effect of the toxic pollutant on such organ-
isms, and the extent to which effective control is being or may be achieved
under other regulatory authority."   (Section 307(a)(2) as amended in 1972).
Furthermore, Section 307(a)(4) of the Act directed EPA to establish effluent
standards at a level which provided  "an ample margin of safety."  To derive
such a level, EPA first reviewed the toxicity considerations enumerated  in
Section 307(a)(2) (described above).  EPA regarded these toxicity considera-
tions as "the most important elements in setting the standards."11

     Toxicity information for the six pollutants was assembled in water  qual-
ity criteria documents published by  EPA.  The criteria documents presented
data derived from laboratory studies and field observations on a variety of
organisms including invertebrate, vertebrate and mammalian test species.
Investigations conducted by EPA's Office of Research and Development provided
acute and chronic toxicity data concerning the feeding of aquatic organisms
and consumers of aquatic organisms.  Furthermore, bioaccumulation studies,
human toxicity data, mammalian carcinogenesis studies, persistence informa-
tion, and degradability data were used to evaluate toxic effects of pollu-
tants.  Since data were not available on all species, EPA' relied on a wide
range of toxicity data for a phylogenetic cross section of organisms as  well
as species representative of a wide  geographic distribution.12

     The "importance" of organisms likely to be affected by the effluent
standards was evaluated as required  by Section 307(a).  EPA assessed the
ecological importance of an organism by examining

          (1)  the role the organism played within the ecosystem,

          (2)  the relationship of the organism to the food chain
               within the aquatic community, and
      10 Proposed Toxic Pollutant Effluent Standard  for PCBs, 41 FR  30468,
July  23, 1976.

      :i 41 FR 23579, June  10,  1976.

      12 Ibid.

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                                   2-59
         (3)  the connection, of the organism 1:0 consumers of aquatic
              life, including humans.

    To assess human healrh effects, EPA generally relied on extrapolations
from animal data, although in some cases clinical and apidsmiological sruciss
were available.   Determinations of a. chemical's carcinogenicity wera aace
following the principle that any substance shown to cause tumors in aninals
was considered a suspect human carcinogen.13

    Human beings were not specifically identified in Section 307 as organisms
to be protected by effluent limitations but EPA interpreted the statute to
require the protection of human health in addition to aquatic life.  In supp-
ort of its position, the Agency referred to Section 402(k) of the Clean Water
Act which describes standards imposed under Section 307 as intended for "toxic
pollutantCs) injurious to human health."  In addition, the definition of
"toxic pollutant" in Section 502(13) mentions health effects in humans as well
as in aquatic organisms.  EPA cited a report of the Senate Committee on Public
Works which describes the definition of "toxic pollutant" referred to above  as
"a benchmark for evaluating those pollutants which in certain concentrations
would have a particularly adverse impact on humans as well as other forzs of
life."1*  This report also suggested that EPA consider in promulgating
standards "the seriousness and irreversibility of any effects on man or the
environment that night occur" and "the possibility for incorporation into bio-
logical organisms and man in concentrations which the latest scientific knowl-
edge suggests will produce effects on man and organisms.":s  For these rea-
sons, EPA promulgated 40 CFR 129.5(c)(2) which states "... all toxic pollu-
tants for which standards are set under this Part are deemed to be injurious
to human health within the meaning of Section 402(k) of the Act unless ether-
wise specified.   .  .".

Recommended Maximum Ambient Levels

    In addition to toxicity data and human health effects information, EPA
used the recommended maximum ambient level for each pollutant as a guide to
establish regulatory requirements.  The recommended maxiaum ambient levels
were published by EPA in the criteria documents to provide "an ample margin  of
safety" for aquatic organisms and others up the food chain, including humans,
who may be exposed to it.14  The recommended ambient level was referred to
     13 Water Quality Criteria, 44 ?R  15930, March  15, 1979.

     14 S. Rept. No. 92-414, 92nd Cong, 1st Session, October 23,  1971, p.  77.
Also "A Legislative History of the Water Pollution Control Act Amendments  of
1972," p. 1495.

     1! "Legislative History." p. 1496.

     15 41 T3. 23579, June 10, 1976.

-------
                                   2-60
as the ambient water criterion and was expressed in microgratns per liter
(ug/1) or the equivalent measurement of parrs per billion (ppb).   Ambient
water criteria were based solely on data and scientific judgment, and did not
reflect considerations of economic or technological feasibility.

Deriving Effluent Limitations from Ambient Water Criteria

     The ambient water criterion numbers served as guides for establishing
effluent limitations.  However, translating a safe water quality criteria num-
ber into an end-of-the-pipe standard is at best an imprecise calculation.1'
Actual discharge concentrations do not normally remain ambient concentrations
because pollutants are diluted and dispersed in the receiving water.  For this
reason effluent limitations established at the level of the ambient water
criterion would be unnecessarily stringent to protect public health.  Instead,
EPA did the "very best that was possible within the bounds of feasibility" to
set standards "which achieved or most nearly approached the ambient water
criterion."1'

     Section 307 of the Clean Water Act (as amended in 1972) did not expli-
citly state that EPA must consider the technological or economic feasibility
of effluent standards.  Because the statute did not preclude consideration of
these factors, EPA decided that "the interests of responsible rulemaking were
best served by giving at least some consideration to technological factors and
the likely impact, if any, of the proposed regulations on the national econ-
omy."13  It is important to emphasize that EPA places "toxicity" and "ample
margin of safety" ahead of "economically achievable" in writing regulations
under Section 307(a).

     EPA based this decision on implications from the language of Section
307.  Section 307(a)(5) authorizes EPA to establish toxic standards at differ-
ent levels for different categories of point sources.  EPA assumed this meant
that the different standards must be based on technological or economic dif-
ferences in the control techniques because health and environmental effects
provide no basis for distinguishing among point source categories.  Further-
more, EPA referred to the language of Section 307(a)(l) and (2) which require
that EPA take into account "the importance of the affected organisms" when
listing and regulating toxic pollutants.  EPA inferred from this language that
the importance of affected organisms should be considered in relation to other
      17 41 FR 23580, June  10, 1976.

      11 Ibid.

      is Preamble to Proposed Toxic Pollutant Effluent  Standards,  41  FR
23578, June  10, 1976.

-------
                                   2-61
important social and economic values, namely economic and technological feasi-
bility, although technological and economic feasibility "must always be given
lass weight than environmental and public health factors."z3

    EPA set the six toxic pollutant effluent liaitations at the point which
represented "the very best that control technology could do" (41 FR 22530).
EPA prohibited discharges of pollutants only if:il

          (1)  there were no known discharges in the category
               covered; or

          (2)  technology could feasibly achieve a prohibition.

In this way, EPA attempted to provide an "ample margin of safety" without  in-
flicting unreasonable and unjustifiable economic and social costs (41 FR
23530).

     Part 129.7 of the regulations gave EPA the authority to impose a aiora
stringent effluent limitation on a particular source than required by the
general effluent standards if:

          (1)  the ambient water criterion was not being net or would
               not be met in the receiving water, and

          (2)  the ambient water concentration  "nay cause or
               contribute to significant adverse effects on aquatic
               or other organisms usually or potentially present or
               on human health."22

This mechanism was included in the regulations to account for unusual receiv-
ing water conditions where general dispersion and dilution do not occur.

Summary:  Effluent Standards Criteria        '

    The criteria used by EPA to establish Toxic Pollutant Effluent Standards
are summarized in Exhibit 2-11.  In addition, the type of standard issued
(i.e., prohibition or limitation of discharges) for each chemical is specified.

    In all cases except for one, benzidine, EPA considered the non-carcino-
genic toxic effects of the chemical on aquatic animals, mammals, and hunans.
    za 41 FR 2357S, June 10, 1976.

    21 Discharges of aldrin/dieldrin, DDT, and ?C3s were prohibited by EPA.
    22 40 CF3 129.7(a).

-------
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-------
                                   2-63
Benzidine-was not studied extensively for non-carcinogenic toxicity since the
main concern was its carcinogenic effects.

     Four of the chemicals were regarded as carcinogens because laboratory
animal experiments demonstrated carcinogenic effects.  The effluent standard
for one of these carcinogens, benzidine, was set by using low-dose extrapola-
tion modeling.  Specifically, the "one-hit" model estimated from laboratory
animal data the concentration of benzidine which would result in carcinogenic
effects in humans.

     All of the chemicals except benzidine were found to be highly persistent
in the environment and resistant to degradation.  Benzidine had neither
characteristic.  Each chemical bioaccumulated and this factor was a primary
consideration in setting the effluent standards.

     Ambient Water Quality Criteria were instrumental, in establishing effluent
standards in each case.  To derive chronically safe exposure levels from acute
toxicity data, EPA multiplied an "application factor" times the demonstrated
acute toxicity levels for aldrin/dieldrin, endrin, DDT, and tcxaphene.::

     After considering the available toxicological information and the ancient
water criteria numbers, EPA set the effluent standards within the bounds of
technological and economic feasibility.  In the case of ?C3s, substitutes for
the chemicals were examined as part of EPA's determination that the ?C3 efflu-
ent prohibition  was economically feasible.

TOXIC POLLUTANT LIST REVISES 3Y THE 1977 AMENDMENTS

     EPA revised the toxic pollutant list in accordance with the 1377 Amend-
ments to the Clean Water Act which directed the Agency to publish the list of
toxic pollutants shown in Exhibit 2-12  (Section 307(a)(l)).  This list of 65
toxic pollutants includes the six pollutants for which effluent standards were
promulgated in 1977 and the nine pollutants for which effluent standards
wereproposed in 1973.  Furthermore, the Clean Water Act Amendments of 1977
require EPA to establish effluent limitations "for every toxic pollutant
referred to" in the list (Section 307(a)(2)).  Through January 1, 1981, no new
effluent standards had been proposed or promulgated for the 65 toxic
pollutants.
     2'Application factors are not uniform among chemicals and are based on
bioaccumulation potential.  An application factor of 0.01 was derived for
aldrin/dieldrin, endrin, DDT, and toxaphene by the National Academy of
Sciences National Academy of Engineering and published in "Water Criteria
1972" (Washington, D.C., 1973).  One application factor was derived for all
four substances above because the substances share similar chemical structures
and bioaccumulation properties.

-------
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                                   2-65
    The list of 65 toxic pollutants was developed by a multidisciplinary cask
force of scientists established by EPA.  The task force conducted a scientific
literature search and reviewed lists of toxic pollutants developed by ether
organisations.  Pollutants were included by the task forca in the list if:

          (1)  the pollutant had'demonstrated carcinogenic,
               mutagenic, or teratogenic effects in humans or in
               laboratory animal testing, or had demonstrated a high
               degree of toxicity at low exposure levels to aquatic
               organisms or systems, and

          (2)  the pollutant was known or was strongly believed to
               be present in industrial discharges.z"

     The list of 65 toxic pollutants was judicially reviewed and accepted by
the Federal District Court of the District of Columbia in NRDC v. Train, 3
ERC 2120 (1976).  This decision settled four lawsuits against the EPA and
approved a comprehensive strategy for the regulation of toxic pollutants undei
the Clean Water Act.2*

     EPA first published the list of 65 toxic pollutants on January 21, 1973
(43 FR 4108).  Subsequently, EPA added the toxic pollutant list  (Exhibit
2-12) to the  federal regulations as part of the General Provisions for
Effluent Guidelines and Standards, 40 CFR 401. IS.2*

PROPOSED REVISIONS OF THE TOXIC POLLUTANT LIST

     Section  307(a)(l) authorizes EPA to revise the list of toxic pollutants,
and specifies that to revise the list, EPA must consider:
     2kRidgeway M. Hall, Jr., "The Evolution and Implementation of EPA's
Regulatory Program to Control the Discharge of Toxic Pollutants to the
Nation's Waters," Natural Resources Lawyer, Volume X, Number 3, p. 518.

     2SThe four lawsuits were:  (1) NRDC v. Train. Civ. No. 2153-73, 6 ERC
1702 (D.D.C., May 23, 1974) where NRDC sued EPA to compel  it to regulate more
than nine compounds under Section 307(a) of the Act; (2) EDF at al. v. Train,
Civ. No. 75-0172  (D.D.C.) where EPA was sued to compel it  to promulgate final
standards for the nine proposed; (3) Citizens for a Bettar Environment, at
al. v. Train, Civ. No. 75-1698  (D.D.C.) where EPA was sued to compel it to
promulgate nine final standards; and  (4) NRDC v. Agee, at  al,, Civ. No.
75-1267  (D.D.C.) where NRDC sought an order for EPA to promulgate pretraatraent
standards under Section 307(b)  for 35 industries.

     2S44 FR 44502, July 30,  1979.

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                                   2-66
          •    rhe toxicity, persistence, and degradability of the
               pollutant,

          •    the usual or potential presence of the affected
               organisms in any waters,

          •    the importance of the affected organisms, and

          •    the nature and extent of the effect of the toxic
               pollutant on such organisms.

     These are the same factors EPA was required to examine when designating
pollutants as toxic under the 1973 version of the Clean Water Act.  To further
clarify the revision process., EPA issued guidance on factors to be included in
petitions for revision of the toxic pollutant list.27  These factors were
not made part of the regulations, but EPA announced in the Federal Register
that the guidance constituted the "information necessary to support any
petition to the Environmental Protection Agency for a change in the toxic
pollutant list."21  The characteristics of a pollutant to be addressed in
revised petitions are:

         (1)  Toxieity

         (2)  Persistence

         (2)  Bioaccumulation, Biomagnification, and Bioconcentration

         (4)  Synergistic Effects

         (5)  Water Solubility

         (6)  Extent of Point Source Discharges

         (7)  Exposure to Persons, Aquatic Organisms, and Wildlife

         (8)  Annual Production in United States

         (9)  Use Patterns

         (10) Analytical Detection
    27 4A FR 18279, March 27,  1979.

    J> Ibid.

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                                   2-67
    It is not necessary for a pollutant to demonstrata adverse affects in.
each of the enumerated areas -for the pollutant to be listed as a toxic pollu-
tant.2'

    As of January 1, 1981, EPA had proposed to add to the list of 65 toxic
pollutants one chemical, ammonia.30  EPA evaluated ammonia in tans of the
ten characteristics of pollutants identified by the Agency's guidance.  The
results of this evaluation are displayed in Exhibit 2-13.  In summary, EPA
proposed the addition of ammonia because the chemical is highly toxic to
aquatic life, highly water soluble, discharged from many point sources, found
in ambient water concentrations exceeding "safe" concentrations,31 present
in U.S. waters with a significant potential for exposure, characterized by a
high annual production, and measurable by existing techniques.

    Following evaluation of public comments, EPA withdrew its proposal to add
ammonia to the toxic pollutants list on December 1, 1980 (45 FR 79692).  The
Agency withdrew the proposal as a result of a change in its position on
whether ammonia was found in ambient waters at concentration levels which
posed human health risks.  EPA concluded that ammonia was not normally present
in ambient waters at concentrations toxic to warmwater fish species or harmful
to human health.  Furthermore, the Agency recognized that Water Quality
Standards (under Section 301(g)) and technology-based effluent limitations
(under Section 301(c)) provided adequate protection of aquatic organisms from
point source ammonia discharges (45 FR 79692).  EPA noted the inefficiency of
controlling ammonia discharges by regulation under Section 307 since, by EPA's
estimates, only 10 percent of ammonia discharged to U.S. waters would be
subject to the regulations (the remainder of ammonia discharged comes from
POTWs which would be unaffected by the proposed listing).'

    Dichlorodifluoromethane (F-12) and Trichlorofluoromethane (7-11").  EPA
proposed to remove dichlorodifluoromethane and trichiorofluoromethane from the
toxic pollutants list on July 9, 1980 (45 FR 46103) in response to a. petition
from E.I. duPont de Nemours Si Company requesting the removal of the two
compounds.31  The petition presented evidence and EPA concurred with the
findings that:
    2t Proposal To Add Ammonia, 45 FR 803, January 3, 1980.

    38 Ibid.

    31 EPA assumed the "safe" concentration was the EPA ambient water
criterion of 20 ug/1 (Quality Criteria for Water, 41 FR 32947, August 6,
1976.)

    31F-11 and F-12 are listed under Halometh'anes in the toxic pollutant
list.

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                                   2-68
                                 EXHIBIT 2-13

           :RITIRIA FOR ADDING AMMONIA TO THE TCXIC POLLUTANT LIST
Pollutant Characteristic
                  Evidence
Persistence
Bioconcentration,
Bioaccumulation, and
Biomagnification
(1)  Un-ionized ammonia is acutely or
chronically toxic to important freshwater and
marine aquatic organisms.

(2)  Ammonia is readily oxidized to nitrite
which is toxic to fish.

(3)  The oxidation of ammonia to nitrite and
then to nitrate lowers the dissolved oxygen
content of water and causes adverse effects to
aquatic life.

(4)  Ammonia is not carcinogenic, terato-
genic, or tnutagenic in humans or animals.

(5)  The toxicity of ammonia is dependent upon
the pH, temperature, and ionic strength of the
water.

Ammonia biodegrades in water and generally is
not persistent.

Ammonia does not have these
characteristics.
Synergisric effects
Water Solubility
Ammonia toxicity is increased by  low  levels  of
other pollutants such as dieldrin.

Ammonia is highly water soluble.
Source:   Toxic Pollutant List:  Proposal to Add Ammonia, 45 FR  803,  January
          3,  1980.

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                                   2-69
                           EXHIBIT 2-13 (continued)

           CRITERIA FOR ADDING AMMONIA TO THE TOXIC POLLUTANT LIST
Pollutant Characteristic

Extent of point source
discharges
                  Evidence
(1)  Toxic concentrations of ammonia are
introduced into the aquatic environment
through municipal sewage effluents, indus-
trial dischargers (leather canning, iron and
steel, petroleum refining, glass, inorgan-
ics, nonfarrous metals, ferroalloys and fer-
tilizer industries), animal production for
slaughtering, and fertilizer application.
Exposure



Annual Production

Use Patterns




Analytical Detection
(2)  Total ammonia concentrations in surface
waters located near large metropolitan areas
average 500 ug/1 and higher.

(3)  Existing ambient water concentrations of
un-ionized ammonia frequently exceed the EPA
criterion of 20 ug/1 ("Quality Criteria for
Water," 41 FR 32947,Augnst 6, 1976).

(4)  Ambient water ammonia concentrations were
found to be highest near selected industrial
discharges, sewage treatment plant effluent
discharges, and near land under intense
agricultural usage.

There exists a significant potential for
exposure of aquatic organisms and wildlife to
ammonia.

High Annual Production.

Most U.S. ammonia production is used in the
manufacture of fertilizers, other inorganic
and organic chemicals,  and in the treatment of
drinking water.

Analytical techniques can measure total
ammonia concentrations  as low as 10 ug/1 in
water.

-------
                                   2-70
         •    the nature of F-ll and F-12 and the methods of
              transportation and disposal of the compounds do not
              provide significant potential for contamination of
              water supplies';

         •    direct contact of the two compounds with water
              supplies results in "transient and low" contamination;
             ' and

         •    the mammalian and human toxicity of F-ll and F-12
              are low.

The final rule deleting F-ll and F-12 from the toxic pollutant list was  issued
on January 8, 1981 (46 FB 2266).

    Bis-(Chlorometfayl) Ether CBCMZ).  EPA proposed to remove Bis-(Chloro-
methyl) Ether from the toxic pollutant list on September 15, 1980  (45 FR
60942) because:

         •    it is not persistent and degrades immediately upon
              contact with water;

         •    it does not bioaccumulate;

         •    there is limited potential exposure of aquatic
              organisms; and

         •    it is not present in point source discharges.

EPA studied the carcinogenic properties of BCME and concluded that BCME  does
not present a risk to human health or to the environment by exposure from
water  (although BCME was shown to be carcinogenic to humans through a:.r
exposure).  As of January, 1981, no final action had been taken because  EPA is
awaiting comment on the proposal from other program offices within the agency,
e.g.,  air programs.33

Criteria Documents for the 65 Toxic Pollutants

    EPA has issued water quality criteria documents for each of the 65 listed
toxic  pollutants in accordance with Section 304 of the Clean Water Act as
amended in 1977.  Revised criteria documents for 64 of the 65 toxic pollutants
were published on iNovember 28, 1980 (45 FR 79318).  EPA announced  that the
last revised criteria document (for TCDD) will be published by March 1,  1981.
EPA will use the criteria documents as guides when establishing effluent
standards for the toxic pollutants.
    33?ersonal communication with staff of the Criteria  and  Standards  Divi-
sion, Office of Water Planning and Standards, EPA on January 14,  1981.

-------
                                   2-71
    Criteria documents must reflect the latest scientific knowledge on the
identifiable effects of pollutants on public health, public welfare, aquatic
life, and recreation.  In addition, the Consent Decree in Natural Rasourcas
Defense Council, et al., v. Train, 8 ERG 2120 (D.D.C. 1976) specified that
the criteria documents must state the maximum recommended concentrations for
each pollutant which will protect aquatic life and human health with an "ampla
margin of safety".  This recommended concentration level is referred to as the
ambient water criterion and normally is expressed in micrograms per liter
(ug/1) or the equivalent measurement of parts per billion (ppb).   Ambient
water criteria must be based solely on data and scientific judgment, and must
not reflect considerations of economic or technological feasibility.

    EPA developed three ambient water criteria numbers for each chemical.  The
three criteria were derived to protect freshwater aquatic life, saltwater
aquatic life, and human health.  Separate water quality criteria were devel-
oped for freshwater and saltwater organisms because some substances may be
more toxic in fresh water than in salt water, or vice versa.'"  In general,
EPA issued one ambient water criterion as a 24-hour average and another as the
ceiling concentration never to be exceeded at any one time.

    The types of information to be included in criteria documents are outlined
in Appendices to the Water Quality Criteria (44 F5 15926):

          •    Appendix B--Guidelines for Deriving Water Quality-
               Criteria for the Protection of Aquatic Life and Its
               Uses, and

          •    Appendix C--Guidelines and Methodology Used in the
               Preparation of Health Effect Assessment Chapters of
               the Consent Decree Water Criteria Documents.

The guidelines describe a consistent way of using available data to derive
ambient water criteria numbers.
     ""'Guidelines for Deriving Water Quality Criteria for the Protection of
Aquatic Life and Its Uses," Appendix 3 to Water Quality Criteria, 44 73 15326,
March 15, 1979.

-------
                                   2-72
             DESIGNATING AND CONTROL OF DISCHARGES 0? HAZARDOUS
                 SUBSTANCES ("SECTION 311)--REGULATORY REVIEW
BACKGROUND

    In accordance with Section 311 of the Clean Water Act,1 EPA promulga-
ted 4 sets of regulations to control the discharge of hazardous substances.2
40 CTR 116 designated 271 substances as hazardous, 40 CFR 117 addressed the
removability of hazardous substances, 40 CFR 118 established rules for the
determination of harmful quantities of hazardous substances, and 40 CFR 119
set forth the methods and procedures for determining and assessing civil pen-
alties for the discharge of hazardous substances in harmful quantities.5

    Prior to their effective date, the hazardous substances regulations were
challenged in a law suit."  Parts 117 and 118 were invalidated by order of a
Federal District Court;  Part 116 was not affected by the ruling.  As  a re-
sult of this lawsuit, Section 311 of the Clean Water Act was amended on Novem-
ber 2, 1978 by the enactment of Public Law 95-576.  The requirement for deter-
mination of harmful quantities was changed to determinations of quantities
"which may be harmful."5  The amended statute no longer requires EPA to make
determinations of removability or units of measurement for computing pen-
alties .
    '•Section 311(b)(2)(A) of the Clean. Water Act authorizes EPA to promul-
gate regulations designating as hazardous substances, other than oil, "such
elements and compounds which, when discharged in any quantity into or upon
the navigable waters of the United States or adjoining shorelines, .  .  .
present an imminent and substantial danger to the public health or welfare
including, but not limited to, fish, shelifisn, wildlife, shorelines, and
beaches" (emphasis added).

    2According to the regulations, 40 CFR 116.3, "'Discharge' includes, but
is not limited to any spilling, leaking, pumping, pouring, emitting,  emptying,
or dumping."  Types of discharges excluded from coverage are discussed  later
in the paper.

    343 FR 10474, March 13, 1978.

    fcSee Manufacturing Chemists Association, et al. v. Costle, et al. 453
F.Supp. 968  (W.D. La., 1978).

    'Clean Water Act, Section 311(b)(4).

-------
                                   2-73
     On February 16, 1979, EPA revoked Farts 117, 113, and 119.  The Agency
proposed a new Part 117 which contained many of the provisions from the former
Part 118.  The most salient change made was that the Part 118 tern "harmful
quantity" was replaced by "reportafale quantity."  Final regulations for the
determination of reportable quantities for hazardous substances discharges, 4Q
CTR 117, were issued on August 29, 1979.*

     These events are summarized in Exhibit 2-14.

DESIGNATION OF HAZARDOUS SUBSTANCES

     EPA has developed a two part selection process for designating hazardous
substances.7  First, elements and compounds are evaluated against
toxicological selection criteria.  Candidate substances which meet at least
one of the toxicological criteria are further examined for discharge poten-
tial.  This use of discharge potential criteria limits the candidate
substances to a practical number and establishes priority of designation.  It
is important to note that discharge potential criteria do not preclude subse-
quent designations of substances initially not designated.  The two types of
criteria are reviewed in detail below.

     The elements and compounds appearing in Exhibit 2-15 have met both the
toxicological selection criteria and the discharge potential screening cri-
teria.*  Thus, EPA in final rulemakings has designated them as hazardous
substances in 40 CFR -116.

Toxicological Selection Criteria

     To determine toxicological effects of chemicals, EPA specified that the
toxicity of elements, compounds, and structural isomers should be evaluated in:

          •    aquatic animals,

          •    mammals, or
     S4A FR 50766 (August 29, 1979).

     Designated hazardous substances include "any isomers and hydrates, as
well as any solutions and mixtures containing these substances."  The regula-
tions define "mixture" as "any combination of two or more elements and/or
compounds in solid, liquid, or gaseous form except where such substances have
undergone a chemical reaction so_as to become inseparable by physical means"
(4-0 CFTR 116.4).  There is no minimum concentration requirement.

      '40 CFR 116.4.

-------
                                   2-74
                                 EXHIBIT 2-14

          SECTION 311 HAZARDOUS SUBSTANCES:  REGULATORY CHRONOLOGY
October 18, 1972.   Section 311 of the Federal Water Pollution Control Act
                    enacted.

December 30, 1975.  EPA publishes (40 FR 59960):

          •    proposed rules for designation of hazardous
               substances, 40 CFR 116.

          •    proposed rules for determination of removability of
               hazardous substances, 40 CFR 117.

          •    proposed rules for determination of harmful
               quantities for hazardous substances, 40 CFR 118.

          •    proposed rules for determination of units of
               measurement ind rates of penalty for hazardous
               substances, 4Q CFR 119.

March 13, 1978.     EPA publishes (43 FR 10474):

          •    final rule designating 271 hazardous substances, 40
               CFR 116.

          *    final rule determining the removability of
               hazardous substances, 40 CFR 117.

          •    final rule defining "harmful quantities" for
               reporting and penalty provisions, 40 CFR 118 and 119.

          •    proposed designation of 28 additional hazardous
               substances, 40 CFR 116.

June 8, 1978.       Preliminary injunction granted, MCA v. Costle.  11 ERC
                    1793  (W.D.La.)

August 4, 1978.     Permanent injunction granted; regulation defining "harmful
                    quantities" invalidated, MCA v. Costle, 11 ERC  2015
                    (W.D.La.)

November 2, 1978.   Clean Water Act, Section 311, amended by Public Law  95-576.

          •    "harmful quantities" replaced by "reportable
               quantitites".

-------
                                   2-75
                           EXHIBIT 2-14 (continued)

          SECTION 311 HAZARDOUS SUBSTANCES:  REGULATORY CHRONOLOGY
          •    EPA no longer required to make determinations of
               removability or units of measurement.

February 16, 1979.  EPA publishes (43 FR 10266):

          •    final rules designating 28 additional hazardous
               substances, 40 CFR 116.

          •    revocation of 40 CFR 117; 40 CTR 118; and 40 CFR
               119.

          •    proposed rales for new 40 CFR 117:  Determination
               of Reportable Quantities for Hazardous Substances.

August 29, 1979.    EPA publishes (44 FR 50766):

          •    final rules for the determination of reportable
               quantities of 299 hazardous substances, 40 CTR 117.

          •    proposed rule for removal of calcium oxide and
               calcium hydroxide ("lime") from the hazardous
               substances list.

November 13, 1979. EPA publishes (44 FR 65400):

          •    final rule deleting calcium oxide and calcium
               hydroxide from the hazardous substances list.

July 9, 1980.       EPA publishes (45 FR 46094):

          •    proposed amendment to 40 CFR 116 expanding the
               criteria for designating hazardous substances to
               include carcinogenic effects on humans; proposal adds
               14 substances to hazardous substances list on the
               basis of carcinogenicity.

          •    proposed amendment to 40 CFR 117 adding reportable
               quantities for substances proposed as hazardous on
               the basis of carcinogenicity.

-------
                                   2-76
          •    aquatic flora.9

Exhibit 2-16 displays the specific toxicological screening requirements for
chemical substances.  Chemicals which meet one of these criteria are referred
to as "candidate substances" and are further evaluated against discharge
potential criteria.  Although there are five possible toxicological criteria,
thus far, EPA has based the designations of -chemical substances as hazardous
solely oc aquatic animal toxicity.

Discharge Potential Screening Criteria

     In order to make the designation of hazardous substances a manageable
process, EPA further screens candidates for designation on the basis of a
chemical's propensity for discharge.  Under Section 311 of the Clean Water
Act, it is net mandatory to consider the discharge potential of a chemical
before designating the chemical as a hazardous substance.  However, EPA
believes it is appropriate to restrict designation to those elements and
compounds which are most likely to be discharged in harmful quantities.1"

     The factors used by the Agency to assess discharge potential are:

         (1)  production quantities,

         (2)  past history of discharge,

         (3)  use and distribution patterns, and

         (4)  cost of the substance.

     Candidate substances are designated as hazardous substances if they have:

          (1)  a spill history,

          (2)  an annual production equal to or greater than 1
               billion pounds,

          (3)  an annual production of less than 1 billion pounds,
               and are used primarily as pesticides, or

          (4)  an annual production of less than 1 billion pounds,
               and have relatively  low market prices and relatively
               high toxicity.
     *43 TR 10474  (March 13,  1978).

     1"Preamble to  40 CFR 116, 43 FR  10473  (March  13,  1978).

-------
                                        2-77
                                     EXHIBIT 2-15

                     LIST OF  DESIGNATED HAZARDOUS SUBSTANCES
Canon Maaa
Ac auldany da
Acaeic acid
Acvci: anhydrida
Aevcona syanohydzin
Acaryl bromida
Aca-eyl caloric*
Acrolain
Aery l3ni™ila
Adipo.c acid
Aldrin
Allyl alcohol
iliyl shlorida
Aluaiaoa (olfa-ea
Amaoaia
lamoru.ua acatata
ABBoru.ua baazoata
Aaaoaiua bicarboaao
Aaaoniu. bxch»°«e.
Ammonium bo^luorida
Amaoraom Swolf if
JkBBIOIUiUn C^ rtHIT^T >
Amaiona.ua c»rbonAC«
Aaaoniua eaload.
Aa^oniua snr^e.
Ammoniam extras*
Synonvraa
Stiianal, athyl aldabyda, acaeic aldanyda
Slaciil acaeic acid, vinagar acid
Aca^s ond., ac^l oxid.
butyronittrila


2-propanal, acrylic aldahyda,
acrylaidanyda, acr&ldetrfda
prop«n«iti=.la, Tiayl cyanxda
S«xan«diOiC acid
Octal«n«, HHDN
2 »y tupaa- l-ol, 1-propanol- 3 ,
Tinyl cariiaol
Chlorallylana
AJ.ua

Acaeic acid immnnioa, salt

Acid amnnnium carbooasa, aaaoaa.ua
nydrogan -arVinaea

iydrogan fluorida

lan^l IIH HHi *Ml ^1^^ ^^m^<" •

ABBoaiom miriaca, *•! aaaoniai:.

ainimmm.ua ci^rara, citric acid
Cacagory
C
C
c
A
0
0
X
3
0
X
3
C
0
B
0
0
a
c
0
0
0
0
0
c
3
S3 ir. Jour.as
( ^ilsorama <
1,000
1,300
1,300
U
5,300 (2
5,300 (2
-
130
5,000 (2
-
100
1,000
5,300 (2
100
5,000 (2
5,000 C2
5,300 (2
1,000
5,000 (2
5,000 !2
5,000 (2
5,300 (2
5,300 (2
1,300
5,300 (2
(454)
(454)
(454)
(4.54!
,273)
,273)
(3.454!
(45.4!
,270)
(0.424)
(45.4)
(454)
,270)
(45.4)
,270)
,270)
,270)
(454)
,273)
,273)
,273!
,273)
,273!
(454)
,27 a )
Ammonium ilueborac*
diamoruun sals

Amsaru,i33 iluoroaorar,*, aoaoiuum
borafluor^da
                                                                       5,300

-------
                             EXHIBIT  2-15

          LIST OF DESIGNATED  HAZARDOUS SOBS ; ^ ;;. _,"7
                              (conr
 r. Naae
saiiide

suliite
                        aaaoaium fiuon.de
                Anaoniua — «*^» *_ 1 i *»*•»

                      , UtS, immnm.um uu.dosiU.f«r>-
                AmmomnTn rhedjuvid*/ ammomua K-J 1* r5 -;'
                *mj'l*c«tj.c ••car, p«»r oil baiuuie ai .X
                        d intiDony,
trichloride     Butter of antlaony

                         fluoride

                           trioxide,  flower* 
                                                                        ' -Did      • ',s " '

                                                                        .!, ooc      • 15 *;

-------
                2-79
              EXHIBIT 2-15
LIST OF DESIGNATED HAZARDOUS SUBSTANCES

Csnan Sams
•.i^itril.
3«nzoyl' chloride
Sanzyl ihlonda
3^Uiu» calorid.
lerylliua fluoride
3.ryliiu» 018K.
n-bucyl phehalata
Butyl accuse
Bucylaaiae
Butyric acid
Cadmium tea-car*
'"^^m"** bronidc
Gao&iizfli ciiloride
Calcivaa arsaaaca
Calciun ars«aifia
Calcium eaxbida
Calciua ehrcaae*
Calcium cyanide
Calsiua dodacylbaa-
Calci>u& hypociilor^fta
Capw
Carbaryl
Carbofuraa
Carbon diaul£ida
Carbon svcraciUon.de
Oilordan*
Chlorxn*
OUonoanzan.
(continued)



3Q -.1 Pounds
SF^onvms Cac*9or*r ' Kllo^raas )
?h«nyl cyanide, cyanobeasen*
Sanzenaearbonyl chloride
•



l,2-b«nzan«dicarboxylic acid, dibucyl
••tar, diburyl phehalac*
Acetic acid bueyl «st»r
l-«ffliao toucan*
Buranote acid, aehylaea-cii: «cid




Carbida, acveylano^ea
Calciua caroaa yallov, geblia.



Oreboea.da-40«, SR-406. v»ncid«-39
Savin

Carbon bisuliida^ dithioeazbonic
aiui/dxxda
Tatrachioro-^aan..™, Perchloron^n.
Toxic.-J.or, cnlardac

Monocalaroeanzana sanxana enlorada
;
C
3
0
Q
a
3
D
C
a
3
3
3
C
C
0
C
*
C
3
A
3
A
3
3
•i
A
3
1,300
1,300
130
5,000
5,000
5,300
100
5,000
1,300
5,300
130
100
130
1,000
1,300
5,300
1,000
10 -
1,000
10ft
10
100
13
5,300
5,000
1
10
100
(454)
(454)
(45.4!
(2,270)
(2,270)
(2,270)
(45.4)
(2.270)
(454)
(2,270)
(45.4)
(45.4)
(45.4)
(454)
(454)
(2,270)
(4S4)
(4.54)
(454)
(45.4)
(4.34)
(45.4)
(4.54)
(2,270)
(2,270)
(0.454)
(4.54)
(45.4)

-------
                2-80
              EXHIBIT 2-15
LIST OF DESIGNATED HAZARDOUS SUBSTANCES

Comnor. Naae
Chlororsrm
Chiorpyrifoi
Chioroeulioaie acid
Chronic acetate
Chromic acid
drome suliace
Chromou* chloride
CabAltom brooide
Csoeltou* formate
Cooaltoua ivlfamate
Couaepho.
Creeoi
Cr otonaldeSy de
Capric acetate
Cupric acetoar»eaita
Capric chlonde
Capric Hisrate
Cupric oxalatc
Capric aulfate
Cuoric aal£ate.
Capric tartrate
Cyanogen chloride
Cyclop
2,4-D acid
2,4— D ««t«r
DDT
Oiazinon
Oicamba
M.ehlob.ai.1
(conrinuec)

Svnonvaui Cateaory
^richloro-than.
Oorsban
Suliuric chlorotydrin

Chronic anhydride, chromim tnoxide
•

Cobalt bromide
Cobalt 2 ornate
Cobalt «u.1,f imate
Co-Kal
Czviylic acid, aydzaxvtolueae
2-buteaai propylene aldehyde
Copper acetate, eryml i red verdign*
Copper ae«eoar«enite, copper
acecate arsenite, Paris ore«n
Copper chloride
Copper nitrate
Copper oxalate
Cooper mlfate
aaaaoniated copper sulfate
Copper tartratc

BexahydTobeszene, hexa-
••thylene, hexanapnuene
2,4-dichloropheaoxyaeetic acid
2,4-dichlorophenoxyaeetic acid eveer
p,?'-DDT
3ipo:ane, Diazitol, Baeudia, Spectracide
2-metnoxy-3,S-dichlorobenioie acid
2,6-dicnlorobeBromtrile, 2,6-OBN
D
X
C
c
c
c
c
c
c
=
A
c
B
8
B
*
B
B
A
B
B
A
C
B
8
X
X
c
c


R3 in Bounds
! Kiloeraas )
5,000
-
1,000
1,000
1,000
1,000
1,000
1,000
1,000
1.000
10
1,000
100
100
100
10
100
100
10
100
100
10
1,000
100
100
1
I.
1,000
1,000
(2,270)
; o.4S 4)
(454)
(454)
(454)
(454)
1454)
(454)
(454)
(454!
(4.54)
(454)
(45.4)
(45.4)
(45.4)
(4.54)
(45.4)
(45.4)
(4.54)
(45.4)
(45.4)
(4.54)
(454)
(45.*)
(45.4)
(0.454)
(0.454)
(454)
(454)

-------
                 •2-81
               EXHIBIT 2-15
LIST  OF DESIGNATED HAZARDOUS SUBSTANCES

Canon Kama
Oiehlona
aichlorobanaan.
Dicnioroprooana
Dicnloropropana
Oiciiloropropana-
(aixrora)
2,2 -Oi chioropropionie
acid
Oichlonres
Oialdria
DtMivUMM
Di-aaciiy lamina
Qlaitrabanzana (mivtd)
Dinitropnanol
Oini trocoluua
W
Oiaulf oton
Oiuron
acid
Endosul£an
sadrin
Spxehlorotaydria
Stoi°n
Stiiy lanadlaat^natatr*-
•cat^c icid (£OTA)
(continued)
3 v itoi i ^nui
Phytjon, dicHloronapirehotjuinona
Di-cttlorida . ?mraaeth (Tcra)
Propyl«na dicnlonda

0-0 aizeara, Vlddaa 0
D^-
2,2-dichlorovi.nyl diaat^yl poo*nhata
Vapooa
*l^t


mnitratunaml
Udif«
OUT
Xquacida, Oaxcrona, Ragiona, Diquit
diteouda
01-,y«oa
DOO, DMD

Thiod»n
Maadzla, Compound 269
Cilaropropylana oxida
Mlalata, ethyl aathylana,
pboqpnorodl-tiiu.oata
\ , '—*l( v\ ""n'h^nt
Sda^^c 4Cid, Hj.7^dota, ( athy lafiadXxu—


X
3
3
0
D
0
A
X
C
c
c
c
c
c
z
a
c
s
X
c
A
e
c
D

' X;
1
100
3,000
5,300
5,300
5,300
13
1
1,300
1,000
1,000
1,300
1,000
1,300
1
130
1,000
1
1
-• 1,300
13
1,300
1,300
5,300

ir. ?ound3
(0.4S4)
(45.4)
(2,270)
(2,273)
(2,273)
(2,2731
(4.54)
(C.454)
(4541
(454)
(454)
(454)
(454)
(454)
(0.4S4)
(45.4)
(454)
(3.454)
(0.454)
(454)
(4.54)
(454)
(454)
(2,270)
            *yn-dlbramo«c.iyl«n*
                                                   1,300
                                                           (454)
                                                   5,300   (2,270)

-------
                                      :-82
                                   EXHIBIT  2-15
                  LIST OF DESIGNATED  HAZARDOUS SUBSTANCES

Comon Nana
'•me ameoniun citrate
Fame aooonium oxaiata
Ferrie chloride
Ferric fluoride
Ferric nitrate
Ferric sulfata
aulrate
Ferroua chloride
Ferroo* culfata
For-ald^yde
Forme acid
Fnmarxe acid
Furfural
Guthion
aeptachior
Bex»chlorocyelop«n-
Bydrocnlonc acid
Bydrofluoric acid
Hydrogen cyanide *
Hydro^n .uliid.
X.opr.n.
laonropanciamiae
(conrinued)

»»»ni» ferric =i=r.,e
ftnoniua f«^i= ox»l««
Flocei mar^is, iron trichloride

Iron aitraca
SuL.^1^; ;:SuL"r
Mohr's *alt, iron aimnnnium suliaee
Iron chloride, iron dichloride,
iron jrccccsicnoa
Green rieriol. Iron vitriol,
iron «ulZat«, iron proeoaulfar*
Hechyl aldehyde, AeichaAal, £ocftalxn
Hetfiannie acid
l?*f*r*»~bm^m*t*t]pitp±?* acid, «rus~
1,2-egtiyleneiiiear boxy lie acid,
boleuc acid, allonalaic acid
2-furaldebyde, pyromncic aldehyde
3u««tiion, asumhoe— meshy 1
Velcicoi-104, Drinox, bepcagran
Perchiorocyclop^dien.
Hydrogen chloride, muriacie acid
Fluorhydric acid
Bydrocyanie acid
Hydroauliuric acid, colfur hydride
2-«e*fty 1-1 , 3-buradi.ene


Caceoory
C
C
C
B
-
c
c
3
;
C
a
0
c
X
X
X
D
D
A
B
C
C


BQ in Pounds
( KiioTrams )
1,000
1,000
1,000
100
1,000
1,000
1,000
100
1,000
1,000
5.000
5,000
1,000
1
1
1
5,000
5,000
10
100
1,000
1,000
(454)
(454)
(454)
(45.4!
(454)
(454)
(454 1
(45. A)
(454)
(454)
(2,270)
(2,270)
(454)
(0.454)
(0.454)
(0.454)
(2,270)
(2,270)
( 4 . i4 )
(45.4)
(454)
(454)
  dodacy 1 b«ni«nr-
JUlt^ian.
Kepone
Oi(p-chloropheny1) —tricnloro-
m»t.hylc»rSinoi, D7MC,  dieofol

Chlordacoa* l,la.3,ia,4,S,5,5a,5b,6-
dacacniorooctahydro-1.3.4-««thano-
2H-cycioour»( cd)p*ncal*B-2-one
                                                                            5,000    (2,270)
                                                                                       (0.454)

-------
                2-83
              EXHIBIT 2-15




LIST OF DESIGNATED HAZARDOUS SUBSTANCES

Canton Nana
Laad acacxea
L»»d araaaan.
Lead chloride
Laad Iluoborat*
Laad fluoride
Laad iodide
Laad aitrafte
Laad scaarac*
La.d >uiia«
Laad «uliida
Laad taiocyanate
Un.Ua.
Lithium chromata
Malatiuon
Malaic acid
Sttleie aahydride
Harcapeadia-^ur
!*«roiric eyaaida
M«rc«ria aitr.,:,
Jtorearle lulfaca
*»«. ^oc^a
M«rcurnvj» ai-sra-«
«.thox7<*ior
Mwchyl aarcapun
M«t-lyl aariaery laca
Hachyl jaritnion
«.vlap0o,
H«cacaraac«
(continued)
Svtsowma
Sugar of laad


Laad fluoroborara
Laad difluorida, pluaboua :iuorid«
•

Staarie acid laad »*ll

aalan,
Laad .ulioeyaaar.
3a»Bur-aac, jaaaa-banzaoa a«xacalorid«

fboapo-tMoa
d»-buran«dlolc acid, cij— l,2-«tliylan«—
dicariioxyllc acid, soxilic acid
2,i— 4-orxndion«, ei*-buranadioic
aa^ydiida, ^oxXlxc aQbTdrida
^.^.rol
K-rcury cy^.id.
H«=ury Bl«rm«.. s-^ary par^Ltrar.
Maicary aulfaca, ••rcory p«rsuliat«
eyaaaca, aarcuue *alfocyaiuda
Majeury precoaicraca
OMDT , aaCboxy-OOT
suiAydzaca, ^xiooaehyl alsoteol
Ha-eiiaerylle acid a«chyi ascar.
Nitrox-ao
Phe.d>»
2a
(2,270)
(2,273)
(45.4)
(3.454)
(4.54)
(4.54)
(4.54)
(4.S4)
(0.454)
(45.4)
(2,273)
(4S.4)
(3. 454)
(454! '

-------
                                     EXHIBIT  2-15
                   LIST  OF  DESIGNATED  HAZARDOUS  SUBSTANCES

Cono n Hame
Monoechy lanine
aonoa.Myla.in.
Haled
Napnchalen*
Haphtoenic acid
Kisxel aimirminm sulfate
Miexal chloride
Niexal hydroxide
Nicxel lu.trats
HicXel suliane
Kimc acid
HisrobenreiM
Kitrooen dioxide
Ki-=ropheaol (muted)
Sitrm:ot:a«n.
Pararermaldehyde
(continued)
Synonyms
Etfiy \ »f«^ f** , uni nfn^r^^T?^
Mechylaaiae, imi nnmathane
Oibroo
«b«« tar. tar SMtphor, aaphthalia
Cyclohexanacarboxylic acid.
*1*m^Ti j w" Tucxel sul£ace
Nickelous chloride
Micxalous hydroxide

Kicxelous su!2a«*
Aqua zorcis
Hitrohenrnl, oil of »1ri>an»
Ki^ro^n «.c»a
1,000
1,000
10
5,000
100
3,300
5,000
1,000
5,000
5,000
1,000
1,000
1,000
1,000
1,000
1,000
(454)
(454)
(4.J4)
(2,270)
(45.4)
(2,270)
(2,270)
(454)
(2,270)
(2,270)
(454)
(454)
(454)
(454)
(454)
(454)
Phenol


Phosaene


Phosphoric

Phosphorus


Phospnorus
           add
Phosphorus pec
  suicide

Phospnorus trichloride
                        DKTP,

                        PCP, Pes&a

                        Carbolic acid,  phenyl  hydroxide,
                                        oxyhensene
Oiphosoene,  earbonyl chloride,
rtilifirof orayl chloride

Or^hophosphoric  acid

Black phosphorus, red phosphorus,
white phosphorus, yellow phosphorus

Pnosphoryl chloride, phosphorus
chloride

Phosphoric sulfide, taiophosphonc
anhydride, phosphorus persulfide

Phosphorous chloride

PCS, Aroclor,  polyehlonnacad
  dipaenyls
    1       (0.4 54)

   10       (4.54)

1,000     (454)


5,000   (2,270)


5,000   (2,270)

    1       (0.454)


5,000   (2,270)
                                                                                100
                                                                                         (45.4)
                                                                               5,000    (2,270)

                                                                                  10        (4.54)

-------
                                     2-85
                                   EXHIBIT 2-15
                  LIST OF DESIGNATED  HAZARDOUS  SUBSTANCES

Qomn H*a«
**a,.ium .»«»«
*ota»ium ar,^-..
Sotaaaium biehromat*
?oca*»ium earomaea
Potaaaium cyanide
*0""iam h7d~Xi'U
9oc**i*imtt p?draca, eauaeie
potaih. poeaaaa
Cham^^ n^-rai
emit*
Trapaaoic acid, B«ciryL»c«ric acid.
Tropaaoic ach^drida, m«tliyi-
?rop«n* oxida
Pyrathrln I, ??r«t!irlo II
l«uocolin«, ehiaolaina, l«ucal
!laiim 4ic*uroo4^«i

Sodium acid, *ul£ita, sodium

Cataoory
-
C
C
A
C
s
A
0
0
0
• C
C
C
C
z
=
C
C
C
9
D


3Q -,i Pounds
(Sil scrams)
1,000
1,000
1,000
1,000
10
1,000
100
10
5,000
5,000
5,000
1,000
1,000
1,000
1,000
-
1,000
1,000
1,000
1,000
5,000
5,000
(454)
(454)
(454)
(454)
(4.54)
(454)
(45.4)
(4.54)
(2.Z-0,
(2,270)
(2,273)
(454)
(454!
(454)
(454)
10.454)
(454)
(454)
(454)
(454)
(2,270)
(2,270)
Sodium :=z




Snrlinm cvaru.d«




Sodiua
C      1,000     (454!




A         10       (4.54)




c      1,000     ;4S4>
Sodiua 'luorid*
                      Villiaursi"*
                                                                        S.OOO   (2,270)

-------
                                          2-S6
                                       EXHIBIT  2-15
                     LIST  OF DESIGNATED  HAZARDOUS  SUBSTANCES
(coiiiinued)
Conraor, tiaae Synoirvms
Sodiun hydro«ulfide Sodium hydrogen suliide
Sodiun hydroxide Caustic soda, soda lye, sodium hydrate
Sodiun hypocolorxte flleeen
Sodium me thy late Sortinm Mthooude
Sodiun nitrite
Sodiun pho senate,
dibasic
^s^rr"""
Sodiaa seienite
Stroatiu. caromat.
Stryoh,^.
Styxm&e Viny Ibenrene , phenyiecJiylane, ceyrol.
•tyrole^, cianaaena, ciananol
Su If uric acid Oil of vitriol, olema
Sulfur monoehloride Sulfur eaionae
2,4,5—; «»<>i-« Acetic acid ( 2,4,5 -tricftloro-

Cateqory
0
C
B
C
B
0
D
C
C
A
C

C
B
B

HQ
(Ki
5,000
1,000
100
1,000
100
5.000
5,000
1,000
1,000
10
1,000

1,000
1,000
100
100

in Pounds
io crams:
(2,270)
(454)
(45.4)
(454)
(45.4)
(2,270)
(2,270)
US4,
1454)
(4.54)
(454!

(454)
(454)
(45.4)
(45.4)
                        po«noxy > -compound wit-i N,2I-
                                         n« (1:1)
                        »e«tie «cid (2,4,5-crielsloro-
                        pb>ooxy)-^onpoaBd with N-
2,4,5-7 «rt*ri

2,4,5-T »*lts


2,4,5-T7 acid


2,4,5-TT «srers
Ac*tic »cid C2,4,5— triehlorcr-
j*«noxy)-cojBpoTiiid with  1-uu.ao-
2— propaaol ( 1 : 1 )

Acetic acid (2,4,S-trichlor0-
pttanmry )-
-------
                2-87
              EXHIBIT 2-15




LIST OF DESIGNATED HAZARDOUS SUBSTANCES
(continued)
Canaan H*m« Synonym*
?»«sa*eiiyl laad L«ad ««rra«?hyl, TZJ.
""^o^at/7*0" T3PJ>
Tolu«n« toluol, B«cSylb«nz«n«,
ph^ny IjE^^^p* , MAC*lACidA
Toica0h98£ f**miph%f*h 1 ^r
trichloro.^.*,. **yl.n. eacUend.
TriciUorton Oiptanx, Dylox
7—. calorapn«nol Callvnuol, Dowieid* 2 or 2S,
C»i«1 , ?h«nacalor
'*T^ ^Ifl Tft*M* 1l"1 1 *r^%«^«
tri«tiy Lamina
tStaMfeUBLM 7«
Oranyl *e«cace
araayl aiarai:.
Vta^ii. p.«oxid. vaa^lic anhydrid., wMle acid anhydrid.
Vanadyi auiia-c« Vaaadie >ul2al*. Taaadiua «ulia-c«
Vinyl acwu-c* Xc«tic acid erhylan* «ta«r
7inylid«n« shlorida l,i-4iciiioro«t:hyl«na, 1.1— iiehloro«Th«n«
Iyl«n« ia-.»«dl Oia«tiiyli«ni«n«, Xylol
Xyl«noi Tl maciy Igoano 1 , hy4roxydia«-ctiyli>«ai«n«
line ac«t*c»
^j^ ^^ a^ffloniOB cixl^Tidv
Sine bane*
Sine bromid*
Zinc carbonari
Sine sixlond* 3iree*r of nnc
Ziac cyaaid*
2ia= ;iuor--d«
Zinc !a».r.
Ziac tiydrssul^i^a

Cag»gory
3
3
C
X
c
c
A
=
0
~
0
D
C
G
C
0
C
-
C
a
c
D
C
0
A
c
-
c

1-;
130
130
1,000
-
1,300
1,000
1C
1,300
5,300
1,000
5,000
5,000
1,300
1,000
1,000
5,300
1,000
1,000
1,300
5,300
1,300
5,300
1,300
5,300
10 "
1,300
1,300
1,300

:4°»r
(45.4)
(45.4)
(454)
(3.454)
(454)
(454)
(4.54)
v4S4)
(2.270,
(454)
(2,270)
(2,270)
(454)
(454!
(454)
(2,270)
(454)
(454)
(454)
(2,270)
(454)
(2,270)
(454)
(2,270)
(4.34)
(454)
1454)
(454)

-------
                                       2-88
                                    EXHIBIT 2-15

                   LIST OF  DESIGNATED HAZARDOUS  SUBSTANCES
                                    (continued)
   Cannon HUM
                                                                             B3  is Pounds
Zinc zii^?a^c

Zinc pn«noisuiion*c«

Zinc paoophid*

Zl2c (.ilicoiluond*

Zinc *ul2«te
                                    Svnonviu
                      2iac colfoorbolm
                      Zinc fluorsilicaxt

                      Whir* vitriol,  tine vitriol
                      white copperas
ilaoride
                                      acid
cclor^dc
0       5,000   (2,270)

D      '5,000   (2,270)

C       1,000     (454)

D       5,000   (2,270)

C       1,000     (454)


D       5,000   (2,270)

D       5,000   (2,270)


5       j,000   !2,;•»!!)

D       5,000   (2,270)

-------
2-89




















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-------
                                   2-90
     EPA relied on production quantity to assess discharge potential because
Department of Transportation and Environmental Protection Agency records
indicated that chemicals which were most abundant in commerce were, in
general, the chemicals spilled most frequently.11  The cut-off point of one
billion pounds was chosen by the Agency as a result of an analysis which
indicated that chemicals produced in excess of one billion pounds annually are
commonly used in highly diversified products and processes.  They are .dandled
and transported in large quantities, and typically have low selling prices.
Since these chemicals are transported in large quantities, EPA assumes that
they are the most abundant in commerce, and thus, are spilled most
frequently.  Candidate chemicals produced in excess of one billion pounds
annually were automatically designated as hazardous substances.

     Candidate chemicals produced in quantities less than one billion pounds
annually were not designated as hazardous substances if they had low
probabilities of spillage.  For example, substances with usages limited to
research, medicinals, food additives, analytical reagents or unknown uses are
not further considered for designation.

     Pesticides were listed as hazardous substances regardless of their
production volume because pesticides are distributed throughout the
environment intentionally and EPA believes them "to have a high probability of
discharge to the water."12

     EPA also considered the selling price of a candidate substance to assess
discharge potential.  Available evidence indicates that substances with
relatively high selling prices have smaller discharge frequencies, since more
expensive chemicals are generally packaged and shipped in smaller quantities
and with greater precautions.  EPA maintains that the additional safeguards in
the manufacture, handling, and processing of substances with high commercial
market values minimize the possibilities of spillage.13  Thus, only
candidate substances with relatively low market prices are designated as
hazardous substances.

     Substances considered by EPA as candidate substances but not designated
because they had low potentials for discharge are listed in Exhibit 2-17.
They were not designated because of one or more of the following factors:
      1lPThis discussion  is derived from the Preamble to the Proposed Rule  for
the Designation of Hazardous Substances:  40 CFR  116.  (40 FR 39964, December
30, 1975).

      1240 FH 59964 (December 30, 1975).

      13  Ibid.

-------
                         2-91
                       EXHIBIT 2-17

MATERIALS DELETED BECAUSE OF LOW POTENTIAL FOR DISCHARGE
    Ammonium Ferrocyanide
    Ammonium Formats
    Ammonium Gluconate
    Ammonium Molybdate
    Antimony Triiodide
    Arsenic Tribromide
    Arsenic Trifluoride
    Arsenic Triiodide
    Beryllium Hydroxide
    Beryllium Phosphate
    Beryllium Sulfate
    Brucine
    Cadmium Fluoborate
    Cadmium Nitrate
    Cadmium Sulfate
    Catecho 1
    Chromous Carbonate
    Chroraous Oxalate
    Cobaltous Acetate
    Cobaltous Chloride
    Cobaltous Citrate
    Cobaltous Iodide
    Cobaltous Nitrate
    Cofaaltous Perchlorate
    Cobaltous Succinate
    Cobaltous Sulfate
    Cupric Acetylacetonats
    Cupric Bromide
    Cupric Gluconata
    Cucrous Iodide
Ferric Glycerophosphate
Ferric Phosphate
Ferrous Qxalate
Hydroquinone
Lead Bromide
Lithium Fluoride
Mercuric Ammonium Chloride
Mercuric Bromide
Mercuric Chloride
Mercuric Iodide
Mercuric Oxide
Mercurous Chloride
Mercurous Iodide
Molybdic Trioxide
Nickel Acetats
Nickel Bromide
Nickel Fluoride
Nickel Iodide
Nickel Pershlorate
Phosphorous Pentafluoride
Pyrogallic Acid
Selenic Acid
Selenium Oxychloride
Tannic Acid
Vanadium Oxytrichioride
Zinc Ammonium Sulfate
Zinc Permanganate
Zinc Propionate
Zirconium Ammonium Fluoride
    Source:  40 FR 59965, December 30,  1975.

-------
                                   2-92
          (1)  No history of spill discharge,
          (2)  Low production quantity,
          (3)  Limited commercial use and distribution, and
          (4)  High value of the substance.14

     Three substances proposed as hazardous substances were deleted by EPA in
the final mlemaking.1S  The substances and reasons for deletion are:
         Antimony Pentafluoride
         Zinc Sulfate Monohydrate
         Adioonitrile
Low potential for discharge
(low production quantity and
limited commercial use and
distribution).

Redundant de s ignat ion
(listing of zinc sulfate
includes monohydrate).

Does not meet Aquatic Animal
Toxicity Requirements
     EPA also deleted 21 substances in the final mlemaking because their
usages are limited to research, medicinals, food additives, or analytical
reagents.  As discussed earlier, EPA considers chemicals with such usages to
have low probabilities of spillage.

                         Chemicals with Limited Use
         Ammonium Hypophosphite
         Arsenic Acid
         Chromyl Chloride
         Cobaltous Fluoride
         Cupric Formate
         Cupric Glycinate
         Cupric Lactate
         Cupric Subacetate
         Cuprous Bromide
         Hydroxy1amine
         Lead Tetraacetate
     Lead Thiosulfate
     Lead Tungstate
     Lithium Bichromate
     Mercuric Acetate
     Nickel Formate
     Stannous Fluoride
     Uranium Peroxide
     Uranyl Sulfate
     Zinc Bichromate
     Zinc Potassium Chromate
     Twelve substances were deleted from the proposed list because they were
determined by EPA to be "not sufficiently toxic to meet the criteria:"16
      Ik40 TR 59965  (December 30,  1975).

      15Proposed in  40 FR 58870-6  (December  30,  1975).

      1S43 FR 10479  (March  13,  1978).

-------
                                   2-93
                           Not.Sufficiently Toxic

                             Aluminum Fluoride
                             Ammonium Iodide
                             Ammonium Bromide
                             Ammonium Nitrate
                             Ammonium Pentafaorate
                             Ammonium Persulfate
                             Propyl Alcohol
                             Sodium Phosphate, Monobasic
                             Sodium Sulfide
                             Zirconium Acetate
                             Zirconium Qxychloride

     On November 13, 1979, EPA deleted calcium oxide and calcium hydroxide
(lime) from the list of hazardous substances.  This action resulted frctn a
Mississippi Lime Company petition for EPA to reconsider the designation of
lime on the basis that:

          (1)  Lime discharges in the past have not resulted in
               environmental damage;

          (2)  Liae has beneficial uses; and

          (3)  Lime's chemistry and its reaction with water preclude
               the acutely toxic efects.

EPA decided that factors  (1) and (2) were irrelevant to the designation of
subtances as hazardous.  The Clean Water Act does not require consideration  of
past environmental damage; moreover, since there were no reporting rsquira-
ments for discharges of hazardous subtances in the past, there was no reason
to assume that a substance had not at one time been discharged and resulted  is.
environmental damage.  EPA disregarded factor (2) because all chemicals pro-
duced commercially, presumably, have beneficial uses.

     Upon consideration of factor (3), EPA deleted calcium hydroxide and
calcium oxide from ^0 CFX 116.  EPA noted that lime is a dry bulk solid vhich
forms a gel-like cover when exposed to watar.  The cover protects acst or the
lime from reaction with water.  Furthermore, the small amount of lime which
does react with water forms calcium carbonate (limestone) which is toxic to
fish only at concentrations much greater than 300 ng/1 (the cut-off
concentration for aquatic animal toxicity).  On this basis, EPA concluded that
calcium hydroxide and calcium oxide do not meet the toxicological selection
criteria, and hence, do not present an "imminent and substantial danger" to
the environment when discharged.

-------
                                   2-94
PROPOSAL TO EXPAND SELECTION CRITERIA TO INCLUDE CARCINOGENIC EFFECTS

     EPA recently proposed to expand the selection criteria for designating
hazardous substances to include carcinogenic effects on humans.:7  Under
this proposal, EPA would designate as "hazardous substances" those elements
and compounds which are known or suspected to cause cancer in hunans.

     The proposed designation of carcinogens as hazardous substances fallows 3.
twc-tiered process, which is similar to the general method for designation
discussed previously.  The primary difference is that rather than assessing
chemicals according to short-term toxicological selection criteria, they are
evaluated according to their carcinogenic (e.g., long-term) potential.

     The designation procedure begins with EPA's Carcinogen Assessment Group
(GAG) making a. qualitative judgment of a chemical's human carcinogenic
potential.  In order to make such a judgment, the GAG considers data including
epidemiclogical evidence, animal bioassay experimental evidence, and
suggestive evidence (studies of chemical structure and short-term tests).  The
GAG evaluates the quality of data supporting human carcinogenicity according
to the following gradient:11

          *    Best Evidence of Human Carcir.ogenicity--Positive
               epidemic logical studies and confirmatory animal tests.

          •    Substantial Evidence of Human Carcinogenicit?--
               Animal bioassay tests demonstrating the incuction of
               malignant tumors or the induction of benign tumors
               that are generally recognized as early stages of
               malignancies, in one or more species.

          *    Suggestive Evidence  of Human Carcinogenicitv--
               Animal bioassay tests demonstrating the induction of
               non-life-shortening benign tumors and also positive
               results in indirect tests of tumorigenic activity
               (e.g., mutagenicity), in vitro cell transformation,
               and initiation-promotion skin tests in mice.

Compounds which demonstrate best evidence or substantial evidence of human
carcinogenicity as defined  above are included in the list of proposed car-
cinogens .
      1745 FR 46094  (July 9,  1980).

      11 See the Proposed Amendment to Expanded Selection Criteria.   45  FR
46094  (July 9, 1980).

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                                   2-95
     Proposed carcinogens are screened further an the basis of discharge
potential.   Substances which meet the discharge potential criteria, described
below are eliminated from consideration as hazardous substances:

          (1)  the substance has never been produced commercially; or

          (2)  the substance is used only as a laboratory raagent,
               medicinal, or specific food additive; or

          (3)  the substance is not produced except as a by-product
               of biological activity (such as aflatoxins); or

          (4)  the substance is not an element or compound, as
               required by law.11  [Examples of such substances
               are soots and tars, which are known to be
               carcinogenic, but are not specific elements or
               compounds.]

     The general discharge potential criteria (described earlier  in this
paper) which focused EPA's regulatory actions on chemicals with large  annual
production levels and low market prices are not applicable to the designation
of carcinogens.  Since the time the general criteria were established, EPA. has
evaluated for possible designation as hazardous substances many substances
produced in large volumes and inexpensively.  EPA is now able to  consider
substances with lower production volumes and higher costs.  The new criteria
were established accordingly.

     In s'ommary, a chemical becomes a candidate for proposed designation as a
hazardous substance on the basis of carcinogenicity if:

          (1)  EPA's Carcinogen Assessment Group qualitatively
               determines that the chemical has carcinogenic
               potential, and

          (2)  there exists a reasonable potential for discharge.

     EPA's proposal to expand the selection criteria also proposes to  amend 40
CFR §116 by adding to the list of hazardous substances.  The 14 substances
listed in Exhibit 2-18 were proposed for designation en the basis of
carcinogenicity.

     In addition to those listed in Exhibit 2-13, EPA's Carcinogenic
Assessment Group originally identified 12 other substances as having
carcinogenic potential.  The 12 chemicals listed in Exhibit 2-19  were
       '45 FS 46095, July 9, 1980.

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                                   2-96
                                 Exhibit 2-18

                CARCINOGENS PROPOSED AS HAZARDOUS SUBSTANCES
           Common Name
          Synonyms or isomers
Benzidine
Bis (2-cliioroe-;hyl)ether
Dibutyinitrosamine



Dichicrobenzidine


Diethyir.itrcsamine




N-Nirrosodimethylamine



Diphenylhydrazine

Kexachlorofaenzene

Kexachiorobiitadiene
(1,1-Biphenyl)-4,4'Diamine;
  p-Diaminodiphenyl;  Eiphenyl;
  4,4-Diamino-;  4-4'-Biphenyldiamine,
  4,4'-Diaminobipheny1.

3is(beta-chloroethyl)ether,  1-chloro-
  2(beta-chloroethyoxy)ethane,
  2,2'-dichlorodiethyl ether, beta,
  beta-dichloroethyl  ether;  di-2-
  chloroethyl ether;  di-(beta-
  chioroethyl) ether, dichioroethyi
  oxide; sym-dichloroethyl ether,
  dichloroether, DCEE

n-Nitrosodibutyiaznine
  n-Nitrosodi-n-burylamine
  Nitrosodibutylamine; DBNA

4,4'-Diamiao-3,3'-Dichlorobiphenyl;
  3,3'-Dichlorobenzidine; DCB

N-Nitrosodiethylamina; Diethylamine;
  N'-Nitroso-diethylnitrosamine;
  N-N-Diethylnitrosamlne; DEN; DENA;
  DANA

Dimethylnitrosamine;  Dimethylaniine;
  N-Nitroso-dimethylnitrosaniine,
  N-N-Dimethylnitrosaiaine; DMN,  DMNA

1,2-Diphenylhydrazine

Perchlorobensene

Perchlorobutadiene; Hexachloro-1,3-
  butadiene; HCBD

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                                   2-97
                                 Exhibit 2-18

                CARCINOGENS PROPOSED AS HAZARDOUS SUBSTANCES
           Common Name
                                 (Continued)
          Synonyms or isomers
Hexachlorocyciohexane
Hexachloroethane
1,1,2,2-Tetrachloroethane
Tetrachloroethyiene
1,1,2-Trichloroethane
alpha:  alpha-benzene hexachloride;
  alpha-HCH;
  1,2,3,4,5 ,6-hexachloroalpha-cvclcr.exana
           alpha-hexachlorocyclanexane;
  1,2,3,4,5,6-hexachlorocycichexane;
  alpha-isomer, alpha-lindane
beta:  trans-alpha-benzene hexa-
  chloride; beta-benzene hexachloride;
  beta-BHC; beta-hexachlorocyclohexane;
  beta-1,2,3,4,5,6-hexachiorocyclohexane;
   1,2,3,4,5,6-hexachlorocyclohexane;
  beta-isomer,beta-lindane

Carbon trichloride; Parchloroethane;
  Carbon hexa-chloride;  Ethane
  hexachloride

Tetrachloroethane, Acetylene tetra-
  chloride; sym-Tatrachloroethane

Ethylene tetrachloride;  Perchloro-
  ethylene

beta-Trichloroethane; Vinyl trichloride
Source:  45 TS. 46097, July 9, 1980.

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                              2-98
                            Exhibit 2-19


     CARCINOGENS NOT MEETING DISCHARGE POTENTIAL CRITERIAa/
                   Arsenic
                   Beryllium
                   Cadmium
                   Chromium
                   bis-Chloromethylether
                   Vinyl Chloride
                   Polynuclear Aromatic Hydrocarbons
                   N-NitrosotyroIodine
                   Tetrachlorocioxin
                   - alpha isomer Hexachlorocyclohexane
                   - beta isomer Hexachlorocyclohexane
                   - gamma isomer Hexachlorocyclohexane
-This list was obtained from EPA's Marine Activities Branch.

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                                   2-99
eliminated from consideration as candidates for designation because they did
not meet the discharge potential criteria.

     EPA plans to evaluate for possible designation other carcinogens identi-
fied in RCRA Section 3001 regulations (Identification and Listing of Hazardous
Waste).2'

     EPA initially considered expanding the selection criteria and the list of
hazardous substances to include substances  which are carcinogenic, nutagenic,
teratogenic, radioactive, and which bioaccumulate in animal tissue to causa
chronic toxic effects.21  However, only criteria for potentially carcino-
genic compounds were formally proposed by EPA.  The Agency deferred considera-
tion of designating substances on the basis of other factors (e.g., mutageni-
city, teratogenicity) until a later date, because of inadequate information
concerning:

         (1)  the appropriate basis for designating these substances;

         (z)  the bioaccumulation factor (i.e., ratio of a
              substance's concentration in animal tissue to that in
              tha aniaal's environment) which is appropriate;

         (3)  how radioactive properties should be considered; and

         (4)  how these substances should be defined.22

DETERMINATION OF REPOR7A3LZ QUANTITIES

    The regulations authorized by Section 311(b)(4),23 40 CFR 117, estab-
lish reportable quantities for all designated hazardous substances, describe
requirements for notification in the event of a discharge, and prescribe
penalty provisions.  This analysis focuses on the factors considered by EPA in
determining the quantities of designated hazardous substances which activate
    28 Ibid.

    21 Advance Notice of Proposed Rulemaking, Proposed Expansion of Criteria
for Designation.  44 FR 10270 (February 16, 1979).

    22 Ibid.

    23The Clean Water Act, Section 311(b)(4), requires the EPA to deter-
mine "those quantities of  ... any hazardous substances  the discharge of
which may be harmful to the public health or welfare of the United States,
including but not limited  to fish, shellfish, wildlife, and public and private
property, shorelines, and  beaches" (emphasis added).  Thesa are termed rapor-
table quantities.

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                                   2-100
the reporting and penalty provisions.   This issue is important to the desig-
nation natter, since these regulations apply to designated substances only if
the resortable quantities are exceeded.

     First, the methodology EPA employs to determine reportable quantities is
described.  Both the methodology for determining reportable quantities on the
basis of acute aquatic toxicity and the methodology based on carcinogencity
are examined.  Then the relationships  between Part 117 and other hazardous
substances regulations (including Department of Transportation regulations)
are reviewed.  The rationale under which discharges are regulated under Part
117 is explained.

Method far Determining Reoerrable Quantities

     Thus far, EPA has relied primarily on the acute aquatic toxieity of
designated substances to derive their reportabie quantities.2*  The other
selection criteria adopted in 40 CFR 116, (the acute toxic effects to mammals
and plants) have not been employed by the Agency, as yet, to designate hazard-
ous substances.  EPA will establish a methodology based on acute toxicity to
mammals or plants once these criteria are utilized to designate hazardous
substances.25  In the meantime, the method for determining reportable
quantities is based solely on acute aquatic toxicity.

     The procedure devised by SPA to determine reportable quantities begins by
placing substances in one of five categories on the basis of acute toxicity to
aquatic organisms.  These five categories are:

         Category X:  Substances which are most highly toxic to
                      aquatic life.

         Category A:  Substances which are highly toxic to aquatic
                      life.

         Category B:  Substances which are moderately toxic to
                      acuatic life.
    2kE?A has proposed a methodology for determining reportable quantities
for substances on the basis of carcinogenicity  (45 FR 46097, July 9,  1980).
EPA is reviewing public comment on the proposal and, as of January  1,  1980, no
final rule had been promulgated.

    2'Preamble to the Final Rulemaking of Part  118--Determination of  Harmful
Quantities for Hazardous Substances.  43 FR 10490  (March  13,
1978).

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                                   2-101
         Category C:  Substances which are slightly toxic to
                      aquatic life.

         Category D:  Substances which are practically non-toxic to
                      aquatic life.

The mean lethal toxicity levels associated with each category are listed in
Exhibit 2-20 under the column entitled "Toxicity Range."  To date, EPA has
relied exclusively on the 96-hour LC50 toxicity test (i.e., the concentration
likely to kill 50 percent of a fish population in 96 hours) to assign
substances to particular categories.

    SPA defined the repcrtable quantity for members of Category X as -he size
of the smallest common commercial container—one pound (or .454 kilograms).
Other categories were thereafter assigned reportable quantities on a
proportional basis.  For example, Category A has a toxicity range of 10 times
Category X's toxicity range, so the reportable quantity for Category A is sec
at 10 times Category X's reportable quantity (i.e., 10 pounds).

    Exhibit 2-20 illustrates the toxicity range and the associated reportable
quantity for each Category.

    The regulations apply only to discharges of reportable quantities "in any
24-hour period".  Neither Section 311 nor its legislative history suggest a
time limit for applicability of reportable quantities.  Thus, EPA set the time
limit of 24 hours to control short-term nonroutine discharges of hazardous
substances.is

    No Consideration of Water Body Characteristics.  It is important to nets
that the reportable quantity for each hazardous substance is constant for all
water bodies covered by the regulations.  Although the characteristics of the
receiving water body such as the type, size, flow, salinity, temperature,
hardness, alkalinity and biological populations affect the toxicity of a
particular hazardous substance, these factors are not considered by EPA when
determining reportable quantities.  The reasons for this are both statutory
and administrative.

    Section 311 of the Clean Water Act requires that the determination of
reportable quantities be made prior to the actual discharge of a hazardous
substance.  Senator Muskie, during Congressional debate on the amendments to
the Clean Water Act, declared that:
     !44 73. 50775 (August 29, 1979).

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                                   2-102
                                 Exhibit 2-20

            EPA CATEGORIES FOR REPORTABLS QUANTITY DETERMINATION


Category                Toxicity Range               Reoortable Quantity
                                                     Pounds  (Kilograms)


    X               LC50-7 < O.lppm                       1.0  (0.454)

    A               O.lppm $ LCSO £ Ippm                   10  (4.54)

    B                 Ippm £ LCSO < lOppm                 100  (45.4)

    C                lOppm S LCSO £ lOOppm               1,000  (454)

    D               lOOppm < LCSO < SOOppm               5,000  (2,270)
    - LCSO values mean the concentration of material which is  lethal  to
one-half of the test population of aquatic animals upon continuous  exposure
for 96 hours or less.
Source:  43 FR 10492 (March 13, 1978).

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                                   2-101
         Category C:  Substancas which are slightly toxic to
                      aquatic life.

         Category D:  Substances which are practically non-'oxic to
                      aquatic life.

The mean lethal toxicity levels associated with each category are listed in
Exhibit 2-20 under the column entitled "Taxicity Range."  To date, Z?A has
relied exclusively on the 96-hour LC50 toxicity test (i.e., the concentration
likely to kill 50 percent of a fish population in 96 hours) to assign
substances to particular categories.

    SPA defined the repcrtable quantity for members of Category X as the size
of the smallest common commercial container--one pound (or .454 kilograms).
Other categories were thereafter assigned reportable quantities on a
proportional basis.  For example, Category A has a toxicity range of 10 times
Category X's toxicity range, so the reportable quantity for Category A is sec
at 10 times Category X's reportable quantity (i.e., 10 pounds).

    Exhibit 2-20 illustrates the toxicity range and the associated reportable
quantity for each Category.

    The regulations apply only to discharges of raportable quantities "ir. any
24-hour period".  Neither Section 311 nor its legislative history suggest a
tiae limit for applicability of reportable quantities.  Thus, EPA set -he time
limit of 24 hours to control short-term nonroutine discharges of hazardous
substances.as

    No Consideration of Water Body Characteristics.  It is important to note
that the reportafale quantity for each hazardous substance is constant for all
water bodies covered by the regulations.  Although the characteristics of the
receiving water body such as the type, size, flow, salinity, temperature,
hardness, alkalinity and biological populations affect the toxicity of a
particular hazardous substance, these factors are not considered by EPA when.
determining reportafale quantities.  The reasons for this are both statutory
and administrative.

    Section 311 of the Clean Water Act requires that the determination of
reportable quantities be made prior to the actual discharge of a hazardous
substance.  Senator Muskie, during Congressional debate on the amendments to
the Clean Water Act, declared that:
    2S44 7R 50775 (August 29, 1979).

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                                   2-102
                                 Exhibit 2-20

            EPA CATEGORIES FOR REPORTASL5 QUANTITY DETERMINATION


Category                Toxicity Range               Reportable Quantity
                                                     Pounds  (Kilograms)


    X               LC50-/ < O.lppm                        1.0  (0.454.)

    A               O.lppm £ LC50 < Ippm                   10  (4.54)

    B                 Ippm £ LC50 < lOppm                  100  (45.4)

    C                lOppm S LC50 < lOOppm              1,000  (454)

    D               lOOppm < LC50 < 500ppm              5,000  (2,270)
    - LC50 values mean the concentration of material which  is  lethal  to
one-half of the test population of aquatic animals upon  continuous  exposure
for 96 hours or less.
Source:  43 FR 10492  (March 13, 1978).

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                                   2-103
          "These (determinations of removability, reportabie
     quantity, and rate of penalty) are nationally applicable,
     before-the-fact decisions and are not expected to reflect the
     myriad of actual circumstances that may occur."27

In order for determinations of reportabie quantities to be made before dis-
charge incidents occur, the specific characteristics of the water receiving
the discharge can not be considered.

     The legislative history and the statutory language indicate that deter-
minations of raportable quantities are not to be based on assessments of
actual harm in the variety of circumstances in which hazardous substances
might be discharged.  Section 311(b)(4) applies to hazardous substances which
"may be harmful"; the statute does not require EPA to demonstrate and predict
those quantities of substances which, under various circumstances, are
harmful.  Rather, Congress expects the reportabie quantities to be "rational
generalized predictions"2* of those quantities which nay be harmful.  Con-
gress intended that the determination (of reportabie quantities) be based on
"chemical and toxic properties of the substance itself, not the circumstances
surrounding its release."23

     Other reasons for not considering the characteristics of the receiving
water body when establishing reportabie quantities are administrative. First,
consideration of all the potentially influencing factors would be administra-
tively impossible for the Agency:  "The- number of potentially influencing
factors and their possible combinations would render any predictive model
based on them entirely too cumbersome for regulatory application."311
Second, if characteristics of the receiving water body are considered when
determining reportabie quantities, dischargers vould be responsible for
differentiating between various types of water bodies.  This is not always an
easy task; frequently, boundaries and types of water bodies are not clearly
defined.  A regulatory approach allowing different repcrtable quantities for
different types of water would "place an unfair burden on dischargers."21
Dischargers would face criminal penalties for failure to immediately report a
     27 Congressional Record at S19653 (December 15, 1977).

     2* See Preamble to the Proposed Rulemaking of Part 117--Detar3ination
of Reportabie Quantities, 44 FR 10271, February 16, 1979.

     29 Ibid.

     30 Preamble to the Final Rulemaking of Part 118—Determination of
Harmful Quantifies for Hazardous Substances.  43 FR 10491  (March 13, 1973).

     31 Ibid.

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                                   2-104
discharge, even though there would be considerable uncertainty as to what
constitutes a violation.  Third, this regulation is intended to establish
prompt notification for discharges of hazardous substances.  If dischargers
are required to evaluate the type of receiving water body, the regulatory goal
of prompt reporting may not be achieved.

     Concentration and Mixtures.  The proposed approach for determining
reportable quantities for mixtures or solutions was to assume that damages
caused fay individual constituents were additive.  Proportions of individual
elements or compounds in a discharged mixture or solution were added to
determine if reportable quantities were exceeded.32  For example, a
discharge of a mixture containing TO percent of a reportabie quantity of
substance A and 60% of a reportable quantity of substance B, would be subject
to the proposed rule because .70 + .60 = 1.30 which is greater than one.

     Prior to the Final Rulemaking, EPA reevaluated the assumption that toxic
properties of different substances can be considered additive.  The Agency
concluded that the additive assumption was "not valid for all combinations of
designated hazardous substances."33  Furthermore, EPA viewed the calcula-
tions for mixtures and solutions as "unnecessarily difficult".3*  Thus, the
regulations were revised so that mention of mixtures and solutions in Part
117.3 was removed.  As a result, discharges of mixtures and solutions are
subject to the regulations only where a component hazardous substance is dis-
charged in a quantity equal to or greater than its reportable quantity, no
matter what the concentration.

Method for Determining Renortable Quantities for Carcinogens

     E?A has proposed to utilize a different method of determining repcrtable
quantities for chemicals likely to be carcinogenic in humans from that
utilized in establishing reportable quantities for chemicals on the basis of
aquatic toxicity.  EPA's rationale for establishing a separate method was that
carcinogens pose different relative risks than substances which demonstrate
acute aquatic toxicity.  For ex-ample, the procedure based on aquatic toxicity
would not designate as reportable a concentration of a substance likely to
kill one fish out of a population of 2,000 fish.  However, a substance  likely
to cause cancer in one person out of 2,000 exposed should be considered
harmful to public health and welfare; EPA proposed a method of assessing
carcinogenic risks to reflect the relative risk (45 TR 46097).
     3 2
        44 FR 10271  (February 16, 1979).
     33 Preamble to the Final Rulemaking of Part 117--Determination of
Reportable Quantities, 44 FR 50767  (August 29, 1979).

     34 Ibid.

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                                   2-105
     This section of the paper summarizes the methodology and rationale that
may be used by ZPA to determine raportafala quantities for potentially
carcinogenic chemicals.3*  Appendix A reviews the details of the methodology.

     First, the Agency would establish "a lifetime cancer risk level thac is
considered sufficiently hazardous to require reporting."  This lifetime risk

level was set at one in one million (10"°).  No reasons for selecting 10
as the level were provided.

     Second, the Agency would construct a "spill analysis model" to describe
the relationship between amounts discharged and risk levels.  This acdel does
not predict the risk of harm for all potential discharge situations.  Rather,
it assumes the discharge of a carcinogen to a water body under worst case
conditions.  Such an approach is permissible according to the statutory
language and legislative history of Section 311, since the spill analysis
model ultimately determines quantities of hazardous substances which aay be
harmful.

     Using the spill analysis model, EPA derived the formula (see Appendix A
for details):

                                  n = 9.35/B

which gives the number of pounds of material, n, having carcinogenic potency,

3, which would result in a lifetime cancer risk of 10

     EPA grouped the designated carcinogens into five categories on the basis
of potential harm.  These categories and respective reportable quantities are
the same as those used by EPA to group the other designated hazardous
substances.  They are listed below in Exhibit 2-21.

List of Reportable Quantities

     Exhibit 2-15, the List of Hazardous Substances, presented earlier, shows
the reportable quantities for each hazardous substance listed in 40 CFR 116.
The first number under the column headed "RQ" is the reportable quantity in
pounds.  'The number in parentheses is the metric equivalent in kilograms.  Th
column labeled "Category" lists the code letters "X", "A",  "3", "C", and "D"
corresponding to the reportable quantities of 1, 10, 100, 1000, and 5000
pounds, respectively.
      1'This description of ZPA's  approach  is taken  from the Preamble  to  the
Proposed Rule:  Determination of  Reportable Quantities for Hazardous
Substances, 45 FR 46097 (July 9,  1980).

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                                   2-106
                                 EXHIBIT 2-21

   EPA CATEGORIES FOR REPQRTABLE QUANTITIES DETERMINATIONS FOR CARCINOGEN'S

Pounds of Substance
Discharged Yielding                                         Reportable Quantity
A Risk of 10-6	                 Category                	(Pounds)	

Less than IX                              1
1 to 10                                 A                             10
10 to 100                               B                             100
100 to 1,000                            C                           1,000
1,000 to 5,000                          D                           5,000


Source:  45 FR 46098, July 9, 1980 (proposed rule).
     Any 24-hour discharge greater than or equal to the reportafale quantity  is
subject to the notification procedures and penalties described in 40 CFR  Parts
117.21 and 117.22.  Discharges covered by these regulations include hazardous
substances which spill, seep, leak or wash into waters or adjoining
shorelines.  There are exceptions to these regulations which are described,  in
detail, later in this paper.

     The 14 substances proposed for designation on the basis of carcinogeni-
city, and their reportable quantities are listed in Exhibit 2-22.
Additionally, EPA proposed to lower the reportable quantities for six
substances that are already on the existing hazardous substances list  in  40
CFR 116.  EPA's rationale for this is that the reportable quantities based on
carcinogenicity are lower than those based on aquatic toxicity.  In order to
prevent either environmental or human risk, the Agency believes that the
smaller of the two reportable quantities should be controlling.  The proposed
changes for reportable quantity values also are presented in Exhibit 2-22.

EXCLUSIONS FROM COVERAGE

     40 CFR 117 covers any 24-hour discharge greater than or equal to  the
reportable quantity except for discharges excluded from Section 311 coverage.
These exclusions inclxide:

           (1)  discharges from facilities with National Pollutant
               Discharge Elimination System  (NPDES) permits, and

           (2)  discharges from Publicly-Owned Treatment Works.

Exhibit 2-23 summarizes the exceptions to 40 CFR  117".

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                                    2-107
                                 EXHIBIT  2-22

           PROPOSED R£?ORTABL£ QUANTITIES  FOR  HAZARDOUS  SU3STANCE5
DESIGNATED
Chemical
Acrylonitrile
Bensidine
bis - (2-chloroethyl ) ether
Carbon tetrachloride-
Chloroform
Dibutylnitrosamine
Dichlorobenzidine
Diethylnitrosamine
Dimethylnitrosamine
Dinitrotoluene
D ipheny Ihydr azine
Ethylene dichloride-
Hexachlorobenzene
Hexachlorobutadiene
Kexachlorocyclohexane
(except gamma-HCH)
Hexachloroethane
1,1,2 , 2-Tetrachloroethane
Tetrachloroethylene
1,1,2 -Trichloroethane
Vinylidene chloride-
ON THE BASIS OF
Category
A
A
B
C
3
X
A
X
X
B
B
C
A
C
A

C
B
C
3
B
C ARC INOGENI CITY
RQ in Pounds
10
10
100
1,000
100
1
10
1
]
100
100
1,000
10
1,000
10

1..000
100
1,000
100
100

r ;'„„-„,,
(-54)
(4.5^)
(45 .4)
(454)
(45.4)
(0.45i)
(4.54)
(0.45*)
(0.454)
(-5.4)
(45.4)
(454)
(4.54)
(454)
(4.54)

(454)
(45.4)
(45-)
(45.-)
(-5.4)
     - The chemical is on the existing  hazardous  substances lis-c iz. 40
116 and has a reportable quantity based on  acute  ::cxicit7 recorded in 4Q C2T3.
117.  EPA proposed to lower the reportable  quantity on the basis of
carcinoganieitv.
Source:  45 FR 46099, July 9,  1980  (proposed rule).

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                                   2-108
                                 EXHIBIT

                    EXCEPTIONS TO 40 CFR
2-23
      Regulation or Source

Marine Protection, Research and
Sanctuaries Act of 1972
(33 USC 1401 et sea.)

Staie and Local Safe Drinking
Water Regulations
Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA)
(7 USC 136 et sea.)
Resource Conservation and Recovery
Act (90 Stat. 2795; 42 USC 6901)
National Oil and Hazardous
Substances Pollution Plan
(40 CFR 1510)

Pollution by Oil and Hazardous
Substances (33 CFR 153.10)
Clean Water Act, Section
311(f)(D
         Specific Exception

   Discharges made in compliance with
   a permit issued under the Act.
   Discharges made in compliance with
   approved water treatment plant
   operations.

   Allowable discharges of a pesti-
   cide registered under section 3 or
   section 24.
   Discharges made under an experi-
   mental use permit issued under
   section 5.
   Discharges made pursuant to an
   exemption under section 18.

   Discharges made in compliance
   with the regulations issiied under
   Section 3004.
   Discharges made in compliance w:.th
   permit conditions under Section
   3005.

   Discharges made in compliance with
   instructions of the On-Scene
   Coordinator.

   Discharges made in compliance with
   instructions cf the On-Scene
   Coordinator.

   Discharges caused solely by an Act
   of God, an Act of War, negligence
   on the part of the U.S.
   Government,  or an act or omission
   of a third party without regard to
   whether any such act or omission
   was or was not negligent, or any
   combination of these clauses.

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                                   2-109
                                 EXHIBIT 2-23
                    EXCEPTIONS TO 4Q CFR 117 REGULATIONS
                                 (•continued)
      Regulation or Source

Clean Water Act
      Specific Exception

Discharges made in compliance
with a permit issued under
Section 404(a).
Discharges exempt from requirements
under Section 404(f) or (404)(r).
Discharges made in compliance with
a permit issued under Section 402.
Other discharges made under Sec-
tion 402, as specified in 117.12.
Discharges excluded from Part
117.12 and from a oermittad source.
Publicly-Owned Treatment Works
(POT*)
Providing Inert Gas to Cargo Tanks
of a Vessel

Demonstration Projects
Discharges made to a POTV from
industrial facilities
Discharges made to a POTW from a
mobile source which has been per-
mitted by the POTW to discharge
that quantity.
Discharges made by FGTWs of sub-
stances received as influent.

Discharges made from a properly
functioning inert gas system.

Discharges approved by EPA en a
case-by-case basis.
Source:   40 CPU Parts 117.11, 117.12, 117.13 and 117.14.

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                                   2-110
    .ne various exceptions allow potential opportunities for gaps in coverage
of Section 211 designated hazardous substances.  A discharge of a hazardous
substance excluded from Section 311 coverage may exceed the Part 117
reportable quantity for that substance, and yet, not be controlled under other
regulatory or statutory provisions.  For example, there are no reportable
quantities for discharges of hazardous substances from facilities with NPDES
permits, but such discharges are excluded from 40 CTS. 117.  This allows the
possibility of discharges which exceed Part 117 reportable quantities and "nay
be harmful".

    Discharges From Facilities With National Pollutant Discharge Elimination
    Svstem (NPDES) Permits

    At the time SPA proposed rules for determining reportable quantities, the
Agency was unclear whether and to what extent discharges from facilities with
NTDES (Section 402) permits were subject to the provisions of Section 311.
The November 2, 1978 amendment to the Clean Water Act (Public Law 95-576)
clarified this issue by distinguishing between discharges subject to Section
311 and those subject to Section 402 on the basis of the source and circum-
stances surrounding the discharge.  Under the Amendment, discharges from
permitted point sources associated with manufacturing and treatment would be
regulated under Sections 402 and 309 of the Clean Water Act, whereas spill
situations would be subject to Section 311 regulations.

    Specifically, the three cases excluded from Section 311 coverage by the
IS 7 8 amendment to the Act are:

          (1)  discharges in compliance with a permit under Section
               402 of the Act;

          (2)  discharges resulting from circumstances identified
               and reviewed and made a part of the public record
               with respect to a permit issued or modified under
               Section 402 of the Act, and subject to a condition in
               such permit; and

          (3)  continuous or anticipated intermittent discharges
               from a point source, identified in a permit or a
               permit application under Section 402 of the Act,
               which are caused by events occurring within the scope
               of relevant operating or treatment systems.35

     Discharges excluded from Section 311 coverage and in compliance with a
permit under Section 402 are subject to controls similar to those found  in 40
CFR 117.  Comparable reporting requirements, civil penalty liability, and cost
of clean-up liability "apply to discharges under both sections.  For this rea-
son, Z?A decided that the NPDES regulations would ccntrol chronic discharges
of Section 311 designated hazardous substances adequately.

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                                   2-111
     The second exclusion applies to discharges of hazardous substances from
Section 402 permitted sourcas which result from circumstances such as chronic
process waste discharges or tank ruptures.  The applicable permit must include
conditions to prevent or contain discharges, or eliminate or abate the
substance prior to discharge (for example, a holding pond to contain sstarials
discharged from a tank rupture) and a system to treat the contained substances
over time).3 7

     On-site industrial spills such as truck or rail accidents, large-scale
failures or ruptures of containers or vessels would not be excluded from
coverage under Section 311.  However, if such on-site spills were processed
through a treatment system capable of eliminating or abating such spills, and
were subject to a permit condition, such discharges would be regulated under
Section 402.  If a discharge of a hazardous substance did not pass through a
waste treatment system or was not otherwise treated in any way, Section 311
would apply.3*

     The third exclusion concerns periodic upsets and failures of treatment
systems resulting in continuous or intermittent discharges.  Examples are
upsets or failures which result from a control problem, an operator error (not
including error causing classic spills, such as accidental tank ruptures,
since such events do not occur within the scope of operation or treatment
systems), a system failure or malfunction, an equipment or system startup or
shutdown, an equipment wash, or a production schedule change, provided that
such upset or failure is not caused fay an on-site spill of a hazardous sub-
stance,1*  Upsets occurring from improperly maintained equipment are not
excluded from Section 311 coverage.

     Exclusion three also applies to discharges resulting from the contamina-
tion of noncontact cooling water or storm water, provided that the water is
not contaminated by an on-site spill of a hazardous substance.""

     Discharges From Publicly-Owned Treatment Works

     Discharges of hazardous substances through Publicly-Owned Treatment Works
(POTWs) may reach navigable waters and, thus, be subject to regulation under
Section 311.  Such discharges can result  from accidental spills of materials
     "40 CFR 117.12(a).

     J744 CFR 10273, February 16, 1979.

     5'40 CFR 50769 (August 29, 1979).

     "40 CFR 117.12(d)(2)(iii).
       '40 CFR 117.12(d)(2)(i).

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                                   2-112
into sewer lines, intentional dumps into manholes, or through routine dischar-
ges made by facilities which use PCTWs to dispose of process wastes."1  EPA
has tried to clarify the difference between chronic discharges to POTws which
should be regulated under Sections 307(b), (c) and 309,"2 and spills to
POTws which should be regulated under Section 3II.*3

     EPA' suggested two possible options for making this differentiation in the
February 1979 Proposed Rulemaking and solicited public comments.  In the Final
Rulemaking for the Determination of Reportable Quantities, EPA rejected both
options and reserved the regulation of discharges from industrial facilities
to POTws until a later date.  The Agency's reasons for reserving regulation
were:

          (1)  The complexity of the issues,

          (2)  The uncertainty about the best way to distinguish
               chronic discharges from spills, and

          (3)  The potential impact of any decision on the thousands
               of facilities which regularly discharge hazardous
               substances to POTto's.*"

     A POTW may not be aware of a hazardous substance received as influent at
the treatment works prior to a discharge; thus, the role and responsibility of
a POTW in this case is difficult to define.  EPA has concluded that "it is
unreasonable to hold the PCTW liable for discharges from users, or under
circumstances which it is unaware of, or unable to control."1*5  The final
rulemaking for 40 CFR 117 reserved the regulation of discharges of hazardous
substances received as influent by a POTW (Part 117.13(a)).  This means that
such discharges from POTWs are meanwhile exempted from Part 117 regulations.
     ul 44 FR  10271  (February  16,  1979).

     42 Section 307 (b) authorizes  EPA to promulgate pretreatment  standards
for pollutants introduced into publicly owned treatment works.  Section  307(c)
authorizes EPA to promulgate pretreatment standards for pollutants  discharged
to POTw's from new sources subject  to standards of performance under Section
306 of the Clean Water Act.  Section 309 describes procedural requirements  for
standards promulgated under the Clean Water Act.

     "3 Proposed Rulemaking for Determination of Reportable  Quantities,  44
FR 10271, February  16, 1979.

     "* 44 FR 50769, August 29, 1979.

     45 Ibid.

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                                   2-113
    Discharges of designated hazardous substances to PQTWs are subject to Par*.
117 regulations where a discharge of a reportable quantity is oiada to a sewer
system from a track, train, or other mobile source which has not "contracted
with or otherwise received written permission from the owners or operators of
the PGTW to discharge that quantity."*5  For example, discharges to a sewer
system by a waste hauler who contracts to discharge specified hazardous
substances to the sewer would not be covered by 40 CFR 117.  However, an
illegal discharge or "midnight dump" as well as any accidental discharge by a
mobile source to a POTW's sewer system would be subject to the applicable
provisions of 40 CFR 117.*7

    EPA singled out mobile sources to be regulated separately frcm industrial
facilities for these reasons:

          (1)  Mobile sources are not subject to NPDES permits,
               industry specific effluent limitations, or
               pretreatment standards.

          (2)  PQTWs cannot design or operate the treatment works to
               assure that the discharge of unanticipated hazardous
               substances by a mobile source would not reach
               navigable waters.

          (3)  POTWs may not even know of the presence of a
               hazardous substance unless notified.

          (4)  In some cases, PQTWs lack the authority to control
               discharges by mobile sources.

          (5)  Out-of-town carriers of. intra and interstate
               commerce, unlike fixed facilities, may not be aware
               of the existence of local requirements for
               notification, pretreatment, or clean-up in the event
               of a spill to the sewers.

          (6)  Spills involving mobile sources are difficult to
               anticipate in advance and prevent.**

    Section 311 does not give EPA the authority to require mobile sources who
spill to PQTWs to notify the PQTV.  Thus, Part 117 regulations requira only
     !40 CFR 117.13(b).
    "'44 FR 50770 (August 29, 1979).
      'See 44 ?R 50771 (August 29, 19',

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                                   2-114
that a mobile source notify the Coast Guard in the event of a discharge to a
PC7W.

Spills During Transport

    Part 117 regulations apply to discharges of hazardous substances from
vessels, onshore facilities, and offshore facilities, unless the discharge is
covered by the exceptions discussed earlier. "**  Section 311 (a)(10) defines
"onshore facility" to include motor vehicles and rolling stock.  Thus, the
applicability of Part 117 regulations to the transportation of hazardous sub-
stances needs to be explored.  In particular, the responsibilities of EPA and
the Department of Transportation need to be clarified.

    At the time of the final rulemaking for 40 CFR 117, EPA deferred the
effective date of Part 117 regulations as they apply to discharges from common
carriers including railroads and many trucks because:50

          (1)  At that time, common carriers were required by law to
               transport all shipments offered to them in accordance
               with applicable tariff requirements.

          (2)  There was no legal requirement for shippers to
               identify their cargoes as containing Section 311
               designated hazardous substances.

Common carrier personnel had no means of determining when they were transport-
ing substances subject to Part 117 regulations.  Spills by common carriers
could not be reported unless the personnel had previous knowledge of the pres-
ence of a hazardous substance in the cargo.

    It is important to note that EPA requires private and contract carriers to
follow Part 117 regulations.  Shippers must identify any shipments contain-
ing hazardous substances if requested by a private or contract carrier.  In
addition, these types of carriers may refuse to transport Section 311'desig-
nated hazardous substances.  Hence, private and contract carriers have the
means to determine if they are transporting substances subject to Part 117
regulations, and if so, to abide by the regulations.

    In order to clarify the responsibilities of the Environmental Protection
Agency and the Department of Transportation, DOT promulgated a final rule
specifically addressing the transportation of hazardous substances."'    The
    "'40 CFR 117.21.

    5"44 FR 50775, August 29, 1979.

    S145 FR 34560, May 2.2,  1980.  See discussion in Volume 3, DOT
Regulatory Review.

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                                   2-115
rule, 49 CFS 171, applies to the transportation of hazardous substances in
reportable quantities by rail car, aircraft, and vessel carriers, as well as
interstate and intrastate motor vehicle carriers.

    In the DOT regulations the tera hazardous substance means "a quantity of a
material offered for transportation in one package, or transport vehicle vhen
the material is not packaged, that equals or exceeds the reportable quantity
(RQ) specified for the material in EPA regulations at 40 CFR Parts 116 and
117."5i

    DOT adopted EPA's reportable quantity classifications because:53

          •    The risk involved from transporting hazardous
               materials includes the possibility of unintentional
               releases into or upon the navigable waters or
               adjoining shorelines.

          •    EPA has both the experience and the technical
               resources necessary to deal with the determination
               and designation of hazardous substances mandated by
               the Clean Water Act.

          •    If DOT did not take this action, EPA would be
               required to regulate the transportaton of those
               hazardous substances not covered by DOT regulations.
               This type of split in regulatory coverage would be
               inefficient.

     Tne application of DOT's regulations to mixtures and solutions containing
hazardous substances is illustrated by the inclusion of the following  uable in
40 CFR 171:

         RQ Pounds        RQ Kilograms         Concentration by Weight
                                               Percent            PPM

           5,000             2,270                 10            100,000
           1,000               454      .           2             20,000
             100                45.4               0.2            2,000
              10                 4.54              0.02             200
               1                 0.45              0.002             20
    **49 CFR 171.8.

    "See 44 F3 10677, February 22,  1979  and 45 FR  34569, May 22,  1930.

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                                   2-116
If the reportabie quantity for a certain hazardous substance is 100 pounds.
less than a C.2 percent concentration by weight of that material in a mixture
or solution would NOT be subject to DCT's regulations.  Further, the 0.2 per-
cent or greater concentration by weight of that material must be contained in
one package to be subject to DOT's regulations.

    Thus the DOT regulations are closely related, but not identical to the
Part 117 regulations for discharges of hazardous substances.

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                                   2-117
                                  Appendix A

 PROPOSED METHODOLOGY FOR DETERMINING REPORTABLE QUANTITIES FOR CARCINOGENS



     The worst case assumptions used in the spill analysis rncdel are:

          •    the discharge is into a water supply impoundment at
               the beginning of the drawdown cycle during severs
               drought conditions;

          •    the impoundment serves a population of 10,000
               persons;

          •    no other water supply is available;

          •    the impoundment has no other uses besides water
               supply;

          •    no treatment technology for removing the carcinogen
               is installed;

          •    the carcinogen mixes rapidly and completely at the
               beginning of the drawdown cycle;

          •    at least 75 percent of the water is withdrawn and
               used for water supply;

          •    eighty percent of the contaminant will enter the
               water supply system;

          •    the average daily water use per individual is 4QQ
               liters of which 0.5 percent is ingested; and

          •    the lifetime average daily dose, D, in units of
               milligrams/kilogram of body weight/day is:  D = (4 x
               10  ) n LW, where n is the amount spilled, L is

               lifetime in days, W is body weight, and (4 x 10 ')
               is the total dose of the contaminant received by each
               person.

     The "one-hit" model of low-dose extrapolation estimates the cancer risk
of a particular compound to humans.  EPA expresses the model in terms of this
equation:


                   ? = 3D = (4 x 10*7) 3n/LW         (1)

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                                   2-118
where B is the carcinogenic potency of the compound.  The potency or  "slope
parameter" -for each of the carcinogen's addressed in this rulemaking  are
displayed below.  These potency figures were derived from linear
extrapo1ations of dose-response data for each compound.

From equation (1), the amount of a chemical that produces a risk "P"  is:


                      n = PLW/(4 X 10~')B         (2)


EPA assumes that the parameters of this equation are P = 10   , L = 25,500
days (70 years), and W = 70 kilograms.

     Hence, equation (2) is equivalent to this formula:

                                  n = 9.85/B

which gives the number of pounds of material, n, having carcinogenic  potency,
3, which would result in a lifetime cancer risk of  10

                   CARCINOGENIC POTENCY FOR EACH CARCINOGEN

            PROPOSED FOR DESIGNATION AS A HAZARDOUS SUBSTANCE-7

           Carcinogen                                         Potency

           Acrylonitrile                                      2.0
           Benzidine                                          2.0
           bis-(2-chloroethyl) ether                          0.68
           Carbon tetrachloride                               0.0901
           Chloroform                                         0.15
           Dibutylnitrosamine                                 27
           Dichlorobenzidine                                  1.9
           1,2-Dichioroethane                                 0.048
           1,1-Dichloroethylene                               0.26
           Diethylnitrosamine                                 38
           Dimethylnitrosamine                                13
           Dinitrotoluene                                     0.42
           D iphenyIhydr az ine                                  0.72
           Hexachlorobenzene                                  2.5
           Hexachlorobutadiene                                0.049
           Hexachlorocyclohexane                              2.0
           Hexachloroethane                                   0.015
           1,1,2,2-Tetrach.loroethane                          0.16
           Tetrachloroethylene                                0.084
           1,1,2-trichloroethane                              0.12


           Source:  45 FR 46098  (July 9, 1980).

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                                       J-f
               THE SAFE DRINKING WATER ACT — STATUTORY REVIEW
INTRODUCTION

    In December of 1974, Congress approved an amendment to the Public Health
Service Act authorising a new section to cover public drinking water
supplies.  Title XIV, the Safe Drinking Water Act,1J authorizes EPA to
establish federal standards to protect public water systems from flarar.il
contaminants, and establishes a joint Federal-State system for ensuring
compliance with the standards and for protection of underground sources of
water.  The purpose of the legislation was to assure that public water
supplies meet minimum standards for protection of public health.

    At that time, there was a lack of federal authority to deal with
contaminants in drinking water.  Under the original Public Health Service Act,
EPA was authorized to regulate contaminants only to prevent the spread of
communicable diseases, and then only applied to interstate carriers.  A 1970
study by HEW had shown a large(36%) percentage of drinking water was
contaminated with harmful chemicals and bacteria, and exceeded the existing
1962 Public Health Service limits (42 CF3. 70) which have since been superseded
by EPA regulations.  In addition, there was a lack of authority, techniques,
and resources at the State and local level for enforcement of any standards
that were available.2-

    Consequently, Congress expanded EPA's regulatory authority to include the
establishment of drinking water standards.  More specifically, the SDWA auth-
orized EPA to promulgate:

         •    interim and revised primary drinking water
              regulations to control contaminants which "may have
              an adverse effect" on human health; where contaminant
              is defined as "any physical, chemical, biological or
              radiological substance or matter in water;" [Section
              1401(6)]

         •    secondary drinking water regulations to provide
              guidelines to states for the control of certain
              contaminants in drinking water to protect the public
              welfare; and
     iJPL 93-523, enacted by Congress December 3, 1974; signed by the
President December 17, 1974; amended by PL 95-190, November 16, 1977; PI
96-63, September 6, 1979.  See 42 U.S.C. §300f et. seq.

     2JHouse Report No. 93-1185, as reported in 1974 United States Code
Congressional and Administrative News  CUSCCAN), ?• 6461.

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                                   3-2

         •    regulations which set minimum requirements for state
              programs designed to control the underground
              injection of chemicals which may find their way into
              public drinking water supplies.

Each of these authorities will be reviewed following an overview of the
statutory criteria.

NATIONAL INTERIM PRIMARY DRINKING VATSR REGULATIONS

    To meet its first, short-term goal, the Act directed EPA to promulgate
"national interim primary drinking water regulations"  (NIPDWSs) within nine
months of the date of enactment in 1974.  In setting such a stringent
deadline, Congress1 goal was to get a set of standards  (or so-called "interim"
regulations) enacted as quickly as possible, based on currently available
information.  As the Act was worded, these interim standards were to (1)
specify "contaminants which, in the judgement of the Administrator, may have
an adverse effect on the health of persons",3-1 and (2)  "protect health to
the extent feasible, using technology, treatment techniques, and other means,
which the Administrator determines are generally available (taking costs into
consideration) on the date of enactment of this title."*-1

    In setting these standards, EPA was to base its decisions on
"epideniological, toxicological, physiological, biochemical or statistical
research or studies or extrapolations therefrom."  Congress, however, did not
want EPA to wait for harm to the public to occur--the preventive purpose of
the legislation requires that the EPA Administrator make a reasoned and
plausible judgment that a contaminant may have adverse  health effects.5-'
Congress anticipated that the interim regulations would be based on a review
and update of U.S. Public Health Service drinking water standards.

    The SDWA authorized EPA to control "contaminants"  in drinking water by
specifying either a maximum contaminant level  (MCL) or  treatment techniques
sufficient to protect against "adverse effects on the health of persons" and
to allow an "adequate margin of safety".tj  The decision to adopt an MCL
over technology-based standards is to be made  "if, in the judgment of the
Administrator, it is economically and technologically  feasible to asc<»rtain
the level of such contaminant in water in public water  systems.  .  . "'J  In
other words, MCLs are to be set for specific pollutants which can be detected,
     '• Section 1401  (1)(B),  (emphasis added).

    '"-Section 1412(a)(2),  (emphasis added).

     IJK. Report No. 93-1185,  1974 USCCAN p.  6463.

     SJSection 1412  (e)(2)(C).

     7JSection 1401  (l)(c)(i)  and  (ii),  and  Section  1401  (1)(3)  (emphasis
added).

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                                   3-3

measured, and monitored in drinking water; treatment techniques should be used
to control all other pollutants for which identification and measurement is
not yet feasible.

REVISED PRIMARY DRINKING WATER REGULATIONS

     The second phase of the strategy was to commence a concerted  longsr-terz
effort to gather additional data identifying the types and concentrations of
pollutants found in drinking water supplies.  These data were to be used to
determine whether revisions were necessary for any or all of the interim
standards and, if so, to provide the scientific information base needed to
make such revisions.  To carry out this data-gathering effort, the Act
required EPA to arrange with the National Academy of Sciences (NAS) "to
conduct a study to determine (A) the maximum contaminant levels which should
be recommended .  . . in order to protect the health of persons from any
known or anticipated health affects, and (B) the existence of any
contaminants "the levels of which in drinking water cannot be determined but
which may have an adverse effect on the health of persons."*-1  In
developing proposals for recommended MCLs, NAS was required to "evaluate and
explain (separately and in composite) the impact" of

         (1)  The existence of groups or individuals in the
              population which are more susceptible to adverse
              effects than the normal healthy adult;

         (2)  the exposure to contaminants in other media than
              drinking water (including exposures to food, in the
              ambient air, and in occupational settings) and the
              resulting body burden of contaminants;

         (3)  synergistic effects resulting from exposure to or
              interaction by two or more contaminants; and

         (4)  the contaminant exposure and body burden levels which
              alter physiological function or structure in a manner
              reasonably suspected of increasing the risk of
              illness.3-1

    Congress intended the NAS proposed levels to represent goals based on
health effects only, and did not intend them to consider what is
technologically or economically feasible or reasonable.1'-1  Besides the
    IJSection 1412(a)(2) (emphasis added).

    *JSection 1412(e)(3).  The phrase "reasonably suspected of increasing
the risk" was not discussed in the Legislative History or defined  in the
statute.

    18JH. Report No.93-1185 1974 USCCAN p. 6472.

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                                   3-4

special health considerations noted above, Congress wanted NAS to  include an
"adequate margin of safety" based on margins of safety currently used in
regulating foods and drugs, pesticides, air and water pollution, etc., as well
as potential health effects.11-1  Results of the NAS study were to be
reported to Congress within two years.  Within ten days of the publication of
the NAS report, EPA was required to publish in the Federal Register the list
of contaminants identified by the report and the recommended MCLs.

    Within ninety days of this publication in the Federal Register, the EPA
Administrator was required to propose recommended maximum contaminant levels
for each contaminant which, in his judgement based on the report, may have
any adverse effect on the health of persons.  Each recommended maximum
contaminant level must be set at a level, at which, in the Administrator's
judgement based on such report, no known or anticipated adverse effects on
the health of persons occur and which allows an adequate margin of safety.
In addition, the Administrator shall, on the basis of the report, list any
contaminants which cannot be measured in drinking water accurately enough to
establish a recommended maximum contaminant level, and which may have any
adverse effect on the health of persons.  Based on available information, the
Administrator may change recommended maximum levels or revise the list.12-1

    Finally, within 180 days of the proposed regulations, the Administrator
was to promulgate "such revised drinking water regulations with such
modifications as he deems appropriate."13-1  The MCL specified in a revised
national primary water regulation was to be as close to the recommended
maximum contaminant level established by the NAS recommendations as is
feasible.  A required treatment technique for a contaminant, for which a
recommended maximum contaminant level has been established shall reduce such
contaminants to a level which is as close to the recommended maximum
contaminant level for such contaminant as is feasible.  A required treatment
technique for a listed contaminant shall require treatment necessary  in the
Administrator's judgment to prevent known or anticipated adverse effects on
the health of persons to the extent feasible.  (The term "feasible" means
with the use of the best technology, treatment techniques, and other  means,
which the Administrator finds are generally available (taking cost into
consideration). l*J

    Revised national primary drinking water regulations were to be amended
"whenever changes in technology, treatment techniques, and other means permit
greater protection of the health of persons, but in any event such regulations
shall be reviewed at least once every three years."15-1
    ::-H. Report No.93-1135, 1974 USCCAN p. 6472.

    12JSection 1412 (b)(l)(B).

    13JSection 1412 (b)(2).

    14JSection 1412 (b)(3), emphasis added.

    1S-Section 1412 (b)(4).

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                                   3-5

SECONDARY DRINKING WATER REGULATIONS

    Unlike the primary regulations, secondary regulations wera to be
promulgated within twelve months of enactment.  The term "secondary drinking
water regulation" is defined as a:

         "regulation which applies to public water systems and which
         specifies the maximum contaminant levels which, in the
         judgement of the Administrator, are requisite to protect
         the public welfare.  Such regulations may apply to any
         contaminant in drinking water (A) which may adversely
         affect the odor or appearance of such water and conse-
         quently may cause a substantial number of the persons
         served by the public water system providing such water to
         discontinue its use, or (B) which may otherwise adversely
         affect the public welfare.  Such regulations may vary
         according to geographic and other circumstances.isj

    Secondary regulations "apply to any contaminant in drinking water which
(A), may adversely affect the odor or appearance of such water".  .  . or  (3),
which may otherwise adversely affect the public welfare.17-1  3ecaus,e they
are designed to protect aesthetic rather than heaith-rslated characteristics
of drinking water, extensive research and data collection were not deemed
necessary to develop secondary regulations, and no interim stage was required.
A second distinction between the primary and secondary regulations  is that
primary regulations are enforceable by either EPA or the State (where a  State
has taken primary enforcement responsibility); secondary regulations "are not
Federally enforceable and are intended as guidelines for the states."1SJ

UNDERGROUND INJECTION CONTROL (UIC) REGULATIONS

    Section 1412 of the SDWA authorizes EPA to promulgate regulations for
State underground injection programs.  Such regulations shall contain "minimum
requirements for effective programs to prevent underground injection which
endangers drinking water."' Section 1421 (d)(2) states that:  "Underground
injection endangers drinking water sources if such injection may result  in the
presence in .... any public water system, of any contaminant, and if  the
presence of such contaminant may result in such system's not complying with
any national primary drinking water regulation or may otherwise adversely
affect the health of persons".  The minimum regulations are to include manda-
tory permits for all underground injections; and inspection, monitoring,
recordkeeping and reporting requirements.  There is not an explicit provision
for designating specific chemicals requiring regulation; the regulations were
    lsJSection 1401 (2), emphasis added.

    17JSection 1412(c).

    ;*-42 ?R 17144 (March 31, 1977), emphasis added.

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                                   J-O

designed to be primarily technology-based.  In prescribing regulations to
control •underground injections, the Act requires the EPA Administrator to,

         .... to the extent feasible, avoid promulgation of
         requirements which would unnecessarily disrupt State
         underground injection control programs which are in effect
         and being enforced in a substantial number of states.ISJ

A regulation is deemed to have a "disruptive" effect "only if it would be
infeasible to comply with both such regulation and the State underground
injection control program."2BJ

BOTTLED DRINKING WATER STANDARDS

    The SDWA also contains a brief provision amending the Federal rood, Drug
and Cosmetic Act by adding the following new section to cover bottled drinking
water:

         "Sec. 410. Whenever the Administrator of the Environmental
         Protection Agency prescribes interim or revised national
         primary drinking water regulations under section 1412 of
         the Public Health Service Act, the Secretary shall consult
         with the Administrator and within 180 days after the
         promulgation of such drinking water regulations either
         promulgate amendments to regulations under this chapter
         applicable to bottled drinking water or publish in the
         Federal Register his reasons for not making such amend-
         ments ."

CASELAW

    The Safe Drinking Water Act was reviewed by the District of Columbia Court
of Appeals in 1978.11J  In that case, EPA's interim drinking water
regulations were challenged as insufficient on a number of specific points  and
were upheld, for the most part, as a proper exercise of agency discretion "in
an area characterized by scientific and technological uncertainty."

    A key issue was the proper scope of the interim standards, and this in-
volved an interpretation of the entire statutory scheme.  The court reviewed
the statutory language and legislative history of the SDWA.  It drew two main
conclusions from its review:

         (1)  Congress "intended the EPA to undertake rapid and
         comprehensive measures in coping with the problem of unsafe
         drinking water.  It seems particularly clear from the
    IJJSection 1421  (b)(3)(B)(i).

    2"JSection 1421  (b)(3)(ii)

    21J EDF V. Costle,  578 F.2d  337  (D.C.Cir.  1978).

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                                   3-7

         legislative history that Congress contemplated prompt
         regulation, whenever feasible, of every contaminant
         identified as possibly injurious to health."

         (2)  Congress established a "phased" approach to drinking
         water regulation so that regulation would remain attuned to
         the "rapidly expanding knowledge of technology."

    The Court felt it would be more constructive to assure that future agency
action would effectively promote the goals of the SDWA than to fashion
remedies to "correct" earlier agency actions.  The Court indicated that the
on-going nature of the SDWA requires the agency to "keep pace with scientific
and technological developments."  It added:

         In light of the clear language of the legislative history,
         the incomplete state of our knowledge regarding the health
         effects of certain contaminants and the imperfect nature of
         the available measurement and treatment techniques cannot
         serve as justification for delay in controlling
         contaminants that may be harmful.

    Where currant knowledge of injurious effects and the costs (and efficacy)
of monitoring and treatment procedures are better-developed and stabla--as for
inorganic water contaminants—the situation is somewhat different.  Tha task
is one of line-drawing:

         Agency expertise and judgment nust be applied in
    determining the optimal balance between promotion of the public
    welfare and avoidance of unnecessary expense.  We will not
    interfere so long as the Agency strikes a balance that
    reasonably promotes the legislative purpose.

    Finally, on reviewing the statutory language of the SDWA and its
legislative history, the Court concluded that revised drinking watar
regulations must "be fully comprehensive in scope."  Controls are not to be
delayed pending the development of more refined data on health effects and
more efficient detection and treatment technology.  The SDWA authorizes EPA to
regulate contaminants despite potential uncertainty about health effects on
proper control levels:

         Primary regulations [i.e., both interim and revised] aust
         specify contaminants which in the judgment of the
         Administrator may have an adverse effect en the health of
         persons when found in drinking water.  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 en the
         health effects of various contaminants in drinking water,
         the Committee did not intend to require conclusive proof

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                                   3-8

         that any contaminant will cause adverse health effects as
         a condition for regulation of a suspect contaminant.
         Rather, all that is required is that the administrator make
         a reasoned and plausible judgment that a contaminant may
         have such an effect.22-1

    The reviewing court also pointed out that the EPA Administrator must
establish a maximum concentration level for, or at least list, each
contaminant which, in his judgment, may have any adverse effect on health.
This reading is consistent with other decisions construing the preventive
nature of environmental protection legislation.
    22JH.R. Rep. No. 93-1185, 92d  long.,  2d  Sess.  (1974) -at  p.10  (emphasis
in original).

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                                   3-9
              THE SAFE DRINKING WATER ACT -- REGULATORY REVIEW
INTRODUCTION

    The Safe Drinking Water Act (SDWA) of 1974 authorized EPA to establish
three regulatory programs addressing different aspects of drinking water
contamination.  As the statutory review has indicated, however, only the
primary and secondary regulations give EPA the option of designating
particular chemicals to be controlled.  For this reason, this review will
focus specifically on these regulations and not the regulations for
underground injection control.

    The MAS report required by Section 1412(e) was released in June of  1977.
As required by the Act, the report was to (1) review the problem of
contaminants in drinking water and (2) recommend maximum contaminant levels
(MCLs) for those pollutants identified.  Based on these recommendations, EPA
was to issue revised primary drinking water regulations to replace any  of the
interim regulations which required such revision.

    The NAS report fulfilled the scientific research aspect of its charge, but
stopped short of recommending specific MCLs.IJ  Lacking this expected
guidance, EPA decided it would not be appropriate to promulgate revised
drinking water regulations, as the SDWA had mandated.  The interim primary
standards are, therefore, still in effect and most are likely to remain in
effect through 1981.2J

    Because the SDWA allows for amendments to the interim: regulations,
however, EPA has been able to use this authority to promulgate additional
interim primary standards for substances not covered in the first round of
rulemaking.  In the recent regulations controlling total trihalomethanes
(TTHMs, a group of organic chemicals found in drinking water), EPA explained
its statutory authority in the following manner:

              Although Congress clearly contemplated the
         comprehensive control of organic chemical contaminants in
         the revised regulations, the statute nowhere precludes EPA
         from establishing requirements as amendments to the interim
         regulations even after the issuance of the report of the
    :jThe NAS panel claimed that because it was a scientific research body
and not a regulatory authority, it would be inappropriate for them to
recommend MCLs which would be the basis for EPA's regulatory actions.
(Personal communication with E. Bellack, Office of Drinking Water, EPA, en
November 12, 1980.)

    '- Ibid.

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         Na.-iDC.al Acaaemy cf Sciences  under  Section  I'-lZfe).   The
         stature cces not require tz,er £.11 regularises  subsequent re
         the KAS report be  issued =s  = Revises.  Regulation.   .ill  that
         13 required is that tne applicable  statutory  criteria be
         aer .   Giver;. Congress' early  concern with  the  crsser.oe cf
         organic cnemicals  in arising water, the  availability cf
         control measures to reduce tne level of TTHMs ,  .  .  .  and
         EPA's finding that THMs "may  have an adverse  affect  or.  the
         health cf persons," amending  the Intern  Regulations  to
         include these requirements as a first  rtep  toward
         controlling organic c.iezical  cor.taninar.ts in  drinking water
         is clearly aurnorizec at this rime.   [-•"•  FR 63625,  Novecoer
         29, 1979 (eapnasis added).]

    The aajor differences between interim and revised  primary  drinking varer
srandarcs is that the former are to be based on "technologies, treatment
techniques and other aears  . . . generally availaale''  as  of  December 2, 197t.
while revisec regulations are to be based on currant "generally  available"
techniques .  Thus, inreria  regulations cannot tax.e advantage  of  developments
in treatment methods over the last six years and are therefore likely to
reflect 3. lower level of control tnan  would  be  possible  'under  revised
standards .

    Both cf the wording of  -he statute and the  failure of NAS  to reco::iend
MCLs or to list those cheiicals for which MCLs  should  be  calculated have
resulted in £?A being given a significant amount cf  discretionary authority i
establishing national priaary drinking water regulations,  as  will be discusse
more fully below.

    This section suzmarizes the major  provisions of  the  SDWA  requiring
regulatory action by E?A and is organized into  the following  sections

         *    Soecif icat ior. of 3he~: cal? to  be  Regulated  "resents
              rne specific  factors wn_cn must  ^or  aay)  enter  into
              EPA ' s decision of wherner or not  a cnecical should be
              regulated under SDWA.

         •    Regulatory Provisions and Status  of  Regulariorr .
              This section  aescribes  rne regulatory  provisions
              developed by  EPA re regulate cot-rasinanrs  in  drinking
              water, and rhe current  status  of  rhe drinking  water
              srandards aurhorized by  the SDWA.

                    "v* _  .lie aoproacnes to regulating c
              esioccied  in  rhe  various  regulations  are discussed and
              compared  in  rhis  final  section.
                                          D
    The specification  and  regulation  cf oor.tas;inanrs requiring prinary
s ran car as were  rhe highesr  priority  acrivities aurhcrized by rhe SDWA, because
these suostancss  are potential  huxan  health hazards.  This section will:  (1)

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                                   3-11

describe the statutory provisions specifying contaminants which ara to be
regulated; (2) discuss the policies which EPA has developed for determining
the substances for which it will promulgate primary standards; and (3) review
the national interim primary drinking water regulations which have been
promulgated to date.

Interim and Revised Primary Drinking Water Standards

    The general procedures by which a chemical is specified for regulation is
authorized by the SDWA.  In the six years since enactment, moreover, EPA has
used the discretionary authority provided,by the Act to define policies and
practices for specifying those substances for which regulations are needed.

    The SDWA defines substances which can be regulated as "contaminants in
water in public water systems, where the term 'contaminant' refers to any
physical, chemical, biological, or radiological substance or matter in
water."5J  Primary regulations are to specify contaminants "which, in the
judgment of the Administrator may have any adverse effect on the health of
persons."J  Both the specification of the anticipated harm ('any adverse
effect')  and of causality ("may have") are left open to discretionary
interpretation on the part of EPA.

    Factors and considerations which EPA is directed to take into account when
promulgating final regulations differ between interim and rsvised primary
regulations .  The interim regulations are required to "protect health to the
extent feasible, . . . (taking costs into consideration)  . . . . "s-  The
term "feasible" is not defined specifically in this context but is later
stated to mean "feasible with the use of the best technology, treatment
techniques, and other means, which the Administrator finds are generally
available.'"-1

    Revised primary standards, which EPA may promulgate to reflect new data or
other information resulting from the MAS study, are to be "set at a level at
which .  . . no known or anticipated adverse effects on the health of persons
occur and which allows an adequate margin of safety."^!

    Once promulgated, revised primary regulations "shall be amended whenever
changes in technology, treatment techniques, and other means permit greater
    3JSection 1401(6).

    *JSection 1401(1)(3) (emphasis added).

    5J Section 1412(a)(2)'.

    SJ Section 141200 (3).

    7J Section 141200 (1) (B) (emphasis added).

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protection of the health of persons.'J  As has been noted above, the key
difference between the two is the higher level of control afforded by  revised
regulations, which may specify technologies developed after December 17,  1974.

    Criteria and Factors for Regulations
    Because the statute provides so little in the way of required procedures,
EPA has established administratively the criteria and factors it will consider
when (1) specifying contaminants to be regulated and (2) establishing the
actual regulations.  The basis for both actions is generally best explained  in
the preamble or body of the regulations themselves.  This section describes
the factors on which agency decisions were based.

    Three specific factors which have been handled somewhat differently  in
each of the interim primary regulations promulgated to date should be noted  at
the outset of this discussion.  The first is the manner in which chemical
compounds are specified in the individual standards; the second addresses the
problem of sensitive segments of the population-at-large; and the third
relates to the use of "safety factors" in calculating an MCL for a particular
substance.

    Chemical Specification..  With one exception discussed below, the interim
regulations for inorganic chemicals do not specify whether a standard refers
to a contaminant only in its elemental form 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 requiring an MCL, EPA specifies the
procedure which must be used by state authorities to test 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.'-1  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 approach and format in this
instance.

    Sensitive Subgroups.  The effects of a given chemical are rarely, if
ever, uniform across the population; certain groups are likely to be more
susceptible or sensitive than others.  A major issue in regulating such
substances is whether standards should be set at a level which protects  the
population-at-large or set so as to protect these especially sensitive
subgroups.
    IJSection  1401(2)  (emphasis added).

    SJPersonal communication with E. BeHack, EPA,  on  October  2,  1980.

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                                   3-13

    The interim primary drinking water regulations promulgated through January
1, 1981, suggest that EPA has adopted a somewhat consistent approach in this
area.  Three of the substances for which MCLs have been set -- fluoride, lead,
and nitrates -- are especially toxic to children or infants.  The MCLs for
these substances have been set at a level low enough to ensure that children
are adequately protected from their toxic effects.

    For other chemicals, however, the Agency's policy has not been as uniform.
Cadmium, for example, is ingested from cigarette smoke, with the result that
smokers have a significantly ihgher total intake than do non-smokers.  The MCL
was set, nonetheless, so as to provide a four-to-one safety factor for
non-smokers; the supporting documentation does not indicate an intent to
ensure protection for the more widely exposed smoking population.  Similarly,
the decision not to set an MCL for sodium was based on the fact that its
effects are felt only by a small segment of the population and, for this
reason, the Agency could not justify establishing a national sodium standard.
Thus, while it is evident that EPA is aware of the "sensitive subgroup"
problem, it is not yet apparent what factors will be used to decide which of
these groups merit special protection.

    Safety Factors.  With respect to the "margin of safety" or safety factor
employed in calculating MCLs, the Agency not only does not pursue a uniform
approach, it specifically states that it has not:

              The standards were not developed by a systematic
         approach to safety factors, at leat partly because of (1)
         amount of knowledge about, and (2) the nature of the health
         risk of, the various contaminants covered a very broad
         range.  The regulations are the result of experience,
         evaluation of the available data, and professional
         review. "^

The final sentence provides a succinct and extremely accurate statement of
EPA's overall approach to establishing the interim policy drinking water
regulations, as the discussion below seeks to demonstrate.

REGULATORY PROVISIONS AND STATUS OF REGULATIONS
    The national interim primary regulations constitute the major portion and
the most important of the drinking water regulations (see 40 CFR 141) .  As of
January 1, 1981, regulations have been promulgated for inorganic chemicals and
certain pesticides and herbicides, radionuclides, and a specific group of
organic chemicals.11-1  Exhibit 3-1 shows the chronology of these
    Iaj40 FR 59575 (December 24, 1975).  Emphasis added.

    lljNational interim primary drinking water regulations for inorganic
chemicals and specific pesticides were promulgated at 40 FR 59566  (December
24, 1975); for radionuclides at 41 FR 23402 (July 9, 1976) and for a specific
group or organic chemicals (total trihalomethanes) at 44 FR 68624  (November
29, 1979).  See 40 CFR 141, Subpart 3.

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                                   3-14



                                 EXHIBIT 3-1

                 CHRONOLOGY 0? SDWA ACTIONS AND REGULATIONS
December 3, 1974


March 14, 1974


August 14, 1973

December 24, 1973

July 9, 1976


July 14, 1976


August 31, 1976


March 31, 1977


February 9, 1978


April 20, 1979

July 19, 1979


November 29, 1979



June 24, 1980


August 27, 1980
Safe Drinking Water Act (SDWA, PL 93-323) enacted by
Congress as an addition to the Public Health Service Act.

EPA proposed National Interim Primary Drinking Water
Regulations (NIPDWRs) (40 FR 11990).

EPA proposed NIPDWRs for Radioactivity (40 ?R 34324).

EPA promulgated Final NIPDWRs (40 ?R 59566).

EPA promulgated Final NIPDWRs for Radioactivity  (41 FR
28402).

EPA issued ANPRM to require control of organic chemicals
in drinking water (41 FR 2S991).

EPA proposed regulations to govern State underground
injection control (UIC) programs (41 FR 36730).

EPA proposed national secondary drinking water
regulations (NSDWRs) (42 ?R 17143).

EPA proposed amendments to the NIPDWRs to control
organic chemical contaminants (43 FR 5756).

EPA reproposed UIC regulations (44 FR 23738).

EPA promulgated NSDWRs and proposed amendments to
NIPDWRs (44 FR 42198, 44 FR 42247).

EPA promulgated Final NIPDWRs to control Trihalomethanes
(THMs)  (44 FR 68624).  States must begin monitoring THMs
in drinking water by November 29, 1980.

EPA promulgated Final Criteria and Standards for the UIC
Program (45 FR 42500).

EPA amends interim primary drinking water regulations
(45 FS  57332).

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                                   3-15

regulations.  While all are pare of the same general regulatory package, each
regulation was proposed and promulgated separately and reflect somewhat
different criteria and approaches, as the discussion below seeks 1:0
demonstrate.

    Inorganic Chemicals and Organic Pesticides and Herbicides

    As Congress had intended when the SDWA was drafted, the interim
regulations were based largely on the Public Health Service Drinking Water
Standards of 1962.  The 1962 standards, which were simply guidelines for state
authorities and did not have the force of law, set maximum limits for nine
substances.12-1  In establishing these limits, the Public Health Service
stated that "Drinking water shall not contain impurities in concentrations
which may be hazardous to the health of the consumers;" health hazards are
defined as "any conditions, devices, or practices in the water supply system
and its operation which create, or may create, a danger to the health and
well-being of the water consumer."  The substances selected for regulation
were chosen because (1) they were known to have toxic or deleterious health
effects in high doses, (2) scientific methods existed for detecting and
measuring their presence in water supplies, and (3) they were known to be
frequently occurring in U.S. water supplies.13-1

    The 1962 standards were reviewed by EPA in light of data ana treatment
techniques developed between 1962 and 1974.  Of the nine substances for which
limits were set in 1962, eight were retained in the final interim primary
drinking water standards published in 1975, and two additional substances were
added, as presented in Exhibit 3-2.  Appendix A to the Regulations, the
"Statement of Basis and Purpose," defines the reasoning followed by EPA in
reviewing the 1962 Standards and setting appropriate MCLs.  The general
principles and factors identified include: litj

         (1)  The substances represent hazards to the health of man.
    l2JThe 1962 Standards (42 CFR Sufapart 72) were simply guidelines to
public water authorities, with no state or federal force of law.  EPA's belief
that Congress' intent was that these Standards should serve as the basis for
the Interim Regulations is stated at 40 FR 59567, in the Preamble to the
NIFDWR final rale.

    13JPersonal communication with EPA Office of Drinking Water staff,
October 7, 1980.

    l*J"National Interim Primary Drinking Water Regulations," EPA
570/9-76-003, pp. 47-128.  This EPA publication contains the final regulations
as published in the Federal Register, as well as the background information
contained in the "Statement of Basis and Purpose" which was released when the
regulations were proposed but not published in the Federal Ragisrer.  7or
this reason, citations for the Statement of Basis and Purpose (Appendix A of
EPA 570/9-76-003)' refer to page numbers in that publication.

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                               3-16



                             EXHIBIT 3-2

         MAXIMUM CONTAMINANT LEVELS FOR INORGANIC CHEMICALS


                                                  MCL, Milligrams
   Contaminant                                       Per Liter

     Arsenic                                           0.050

     Barium                                            1.OCO

     Cadmium                                           0,010

     Chromium   '                                       0.050

     Lead                                              0.050

     Mercury                                           0.002

     Nitrate (as N)                                   10.000 a/

     Selenium                                          0.010

     Silver                                            0.050

     Fluoride                                         1.4-2.4
a/ Some non-community systems may exceed the 10 mg/1 MCL up to 20 mg/1
   under certain controlled situations.
Source:  42 CFR 141.11(b)

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                                   3-17

         (2)  Total environmental exposure to a particular
              contaminant was considered la. calculating specific
              MCLs.  In other words, epa attempted to estimate the
              amount of the substance to which the average peson is
              likely to be exposed from all sources (air, diet,
              water, etc.) and then determine the fraction of total
              intake resulting from ingestion of drinking water.

         (3)  An attempt was made to set lifetime exposure limits
              at the lowest practical level so as to minimize the
              amount of the contaminant contributed by drinking
              water, particularly when other sources are known to
              represent the major exposure.  By "practical" the
              Agency appears to be referring to two factors:   a
              level that is technologically feasible (taking costs
            •  into consideration, as required by the Act) and one
              that takes account of the fact that drinking water may
              be only a minor source of the contaminant in the
              average person's total intake.

         (4)  The regulations are considered a standard of quality
              generally attainable by good water quality control
              practices.  The policy was to set limits not so lew as
              to be impracticable nor so high as to encourage
              pollution of water.

         (3)  No attempt was made to set MCLs for every toxic or
              undesirable contaminant that might enter a public
              water supply; the regulations set forth in the 1962
              Public Health Service Standards formed the basis for
              EPA's interim primary regulations.

         (6)  The MCLs were based on an assumed consumption level
              of two liters of water per day.

         (7)  The MCLs were not intended to provide a uniform
              safety factor, primarily because both the level of
              knowledge and nature of the health risks of the
              various contaminants vary widely.

In addition to these general considerations, specific factors were cited for
each of the following specified chemicals:

    Arsenic is both highly toxic and frequently found in drinking water
supplies, as well as in the air and soil.  The health effects of both acute
and chronic exposure are well documented in laboratory animals and, to a
somewhat lesser degree, in humans.  Minimum-effect and no-effect levels have
been demonstrated in dogs, rats, and mice.  There has been some suggestion
that arsenic may be carcinogenic, though such evidence is inconclusive.13-
    1SJE?A 570/9-76-003, pp. 32-53.

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                                   3-1S

    Z?A review of data generated since the 1962 standard did not indicate tha
  e MCL required revision:

              It is estimated that the total intake of arsenic from
         food is an average of 900 ug/day.  At a concentration of
         0.5 mg/ liter and an average intake of 2 liters per day, the
         inrake from water would not exceed 100 ug per day, or
         approximately 10 percent of the total ingested arsenic. . . .
         In light of our present knowledge concerning the potential
         health hazard from the ingestion of arsenic, the
         concentration. .. in drinking water shall not exceed .05
    Barium is "recognized as a general muscle stimulant, including especially
the heart muscle," and "evidence exists for high acute toxicity of ingested
barium .  .  .  and for chronic irreversible changes in tissues resulting from
the .  .  . deposition of insoluble forms of barium in sufficient amounts."  An
MCL was  determined to be necessary because of the "seriousness of the toxic
effects  of barium on the heart, blood vessels, and nerves."17-1

    No study has identified the amount of barium that may be tolerated in
drinking water.  A threshold limit of 0.5 mg/mj air set by the American
Conference of Governmental Industrial Hygienists in 1958 provided EPA with a
"rational basis for a water guideline."1'-  On the basis of this limit and
by assuming certain rates of absorption into the bloodstream and
gastrointestinal tract, a value of 2 mg/1 was derived as an approximate
maximum concentration level for a healthy adult population.  A "safety factor"
of two to one, to account for more sensitive segments of the population, was
used to derive the MCL of 1 mg/1 as constituting a "no-effect" level in water.

    The Statement of Basis and Purpose does not discuss the amount of barium
typically found in drinking water nor other factors which would indicate why
this substance is particularly a problem in drinking water supplies.

    Cacium is described as a "nones sential, non-beneficial element of high
toxic potential;"15-1 evidence of its acute and chronic toxicity is
documented by numerous studies.  Cadmium is known to enter drinking water
supplies as run-off from certain industrial point sources.  The average amount
of cadmium in U.S. drinking water supplies has been estimated at 1.3 ug/1.

    Diet and cigarette smoking -- not drinking water -- are the major sources
of ingested cadmium.  A review of existing data suggested that 75 ug is a
    1
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                                   3-19

reasonable estimate of average daily dietary intake.  The level of exposure
which may cause chronic cadmium poisoning is currently unknown, though the
studies to date indicate the level to be in the 500-600 ug/day range.  The MCL
was set at 0.01 tng/1; at the average human consumption of two liters or water
per day, it would account for 20 ug/day.  Added to the assumed dietary intake
of 75 ug/day, the MCL provides a "four-fold safety factor" for
nonsmokers.20J  The use of a four-to-one safety factor for cadmium versus
the two-to-one safety factor for barium is never discussed or explained.

    Chromium  is known to be toxic to humans; to produce lung tumors when
inhaled; and  to be found in certain foods; air, including cigarette smoke; and
some drinking water supplies.  Little data are available on either the amount
of chromium present in food or the level of daily intake which can be
tolerated in humans without adverse health effects.  EPA based the MCL of 0.5
mg/1 on several recent studies of toxicity from which "it would appear that  a
concentration of 0.5 mg/1 of chromium incorporates a reasonable factor of
safety to avoid any hazard to human health.21-1  In this case, the margin of
safety (i.e., "four-fold" or "two-to-one" as stated for other chemicals) is
nowhere given explicitly; "reasonable" is as closely as it is defined in the
Statement of  Basis and Purpose.

    Fluoride  is an essential nutrient though it can have adverse and even
fatal effects at very high doses.  The only harmful effect from excessive
fluoride in drinking water observed in the U.S. has been dental flucres is,
particularly  among children.  Optimum fluoride levels in drinking water are
seen as dependent on climatic conditions because the amount of water (and
hence fluoride) ingested by children is influenced primarily by temperature.
The MCLs set  by EPA thus vary with the average temperature of a community, as
shown in Exhibit 3-3.  The optimum concentration level for a given temperature
zone were based on data collected in a 1969 study by the'National Institutes
of Health (NIH).  To arrive at the MCLs, EPA appears to simply have doubled
the optimum level and defined this as the MCL for a particular zone.  The
justification for doubling the optimum level to arrive at the MCLs is not
documented in the discussion of this standard, and the standard was' challenged
in court as a result (Environmental Defense Fund v. Costle, 578 ?.2d 337
(B.C. Cir. 1978).  The Appeals Court found that EPA had acted within its
discretionary authority in setting MCLs for fluoride at twice the optimal
level.

    Lead is well known to be toxic in both acute and chronic exposures,
particularly  to young children.  A 1969 study estimated that lead
concentrations in treated drinking water ranged as high as . 6<* ing/1, an amount
considered potentially excessive, especially to children.  To 0.5 mg/1
standard was  determined to be (1) generally obtainable by aost drinking water
    Zaj i£id., p. 61  (emphasis added).

    I:J Ibid., p. 63  (emphasis added).

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                                  . 3-20



                                 EXHIBIT 3-3

                   MAXIMUM CONTAMINANT LEVELS FOR FLUORIDE



                 Temperature Degrees                 MCL, Milligrams
                 	Fahrenheit	                    Per Liter

                 53.7 and below                             2.4

                 53.8 to 58.3                               2.2

                 58.4 to 63.8                               2.0

                 63.9 to 70.6                               1.8

                 70.7 to 79.2                               1.6

                 79.3 to 90.5                               1.4
Source:  40 CFK 141.11(c)

-------
                                   3-21

supplies, and (2) sufficiently low to insure that total dietary  ir.take  of
lead by the most vulnerable segment of the population  (children) would  be
below the maximum safa level.22J

    Mercury was not included in the 1962 Standards but was added to  die
NIPDWRs because (1) it posed "an unwarranted threat the health," and (2) data
indicated that mercurial compounds may be present in drinking water
supplies.21J  While mercury poisoning may result from  acute exposure, the
major concern was to guard against the chronic effects resulting from exposure
to small amounts over a long period of time.

    "Safe levels" were estimated using both laboratory and epidemiological
test data.  The contribution of other sources of mercury to daily  ingestion
levels was also considered because "if the total daily intake from all  sources
(air, water, and food) is approaching 30 mg/person/day, the concentration of
mercury . .  .  will have to be reduced if a safety factor of 10 is  to be
maintained.   The MCL of .002 mg/1 is seldom exceeded in drinking water, thus
"the margin of safety gained from the restricted intake ... in drinking
water can be applied to the total intake with minimal  economic impact.Il*-1
In other words, because mercury contamination in drinking water  can  be
controlled to very low levels without incurring significant costs,  the  added
margin of safety thereby achieved can help to offset the intake  from other
sources which may not be as easily controlled.

    The mercury standard is interesting because it is one of the raw cases
where a marginal cost approach to total environmental exposure has been
applied to health and safety regulation.  It is the only such standard
promulgated under the SDWA, though an explanation of why this approach  was
taken, and why only for mercury, is not provided in the supporting
documentation.

    This standard is also unusual because it is the only one which
specifically states that both mercury and "mercurial compounds"  are  to  be
regulated.  All of the other standards simply rely on the prescribed test
procedures to indicate that the MCL refers to compounds as well  as  elemental
forms of the substance.

    Nitrate at levels greater than 10 mg/1 in drinking water has been serious
or fatal to infants, although U.S. water supplis have  frequently excsed.ec this
level with only one such case of nitrate poisoning reported.  The  poisoning
process is poorly understood; additional study was stated to be necessary to
determine more precisely the level at whch adverse health effects  can be
prevented completely.
    22J Ibid.,  p. 71-72 (emphasis added).

    23J Ibid.,  p. 76 (emphasis added).

    2*J Ibid.,  p. 79 (emphasis added).

-------
                                   3-22

    The MCI of 10 mg/1 was selected because "for the usual situation  (it)
will protect the majority of infants."  While MCLs are legally enforceable,
the discussion of nitrate in the Statement of Basis and Purpose states  that:
"If a water supply cannot maintain the NO,-N concentration below the  limit,
                                         •>
diligent efforts must be aade to assure that the water is not used  for  infant
feeding."2*-  The rules have been amended to allow some non-community
systenss to exceed the 10 mg/1 MCL up to 20 mg/1 under certain controlled
situations.2'-1

    Selenium was included in the 1962 Standards because of its possible car-
cinogenicity; recent studies have not supported this potential health effect,
however.  Other apparent health effects include loss of hair, decreased mental
alertness, and gastrointestinal problems, though the levels of selenium intake
resulting in these effects is disputed.27J  Based on a review of the
existing data, the'MCL of 0.01 mg/1 set by EPA "results in a minimum  safety
factcr of 3, considering the lower end of the range of selenium intakes that
have been associated with minor toxic effects. . . . "2i-i

    Silver is intentionally added to some drinking water supplies' as  a
disinfectant.  Its chief effect on humans is cosmetic:  permanent
discoloration of the skin, eyes, and mucous membranes.  Silver at very  high
concentrations has caused diseases of the kidneys, liver and spleen in.
laboratory rats.  Some evidence indicates that, once absorbed, silver is held
indefinitely in tissues.  A review of data generated since the 1962 levels
were set apparently did not suggest a need to revise the 1962 Standard  of 0.05
mg/1.

    Sodium was not included in the 1962 Standards, but public comment on the
proposed Interim Primary Regulations suggested an MCL was necessary.  EPA
reviewed existing data on possible health effects and average sodium
concentration in U.S. drinking water and concluded:

              . .  . the available data do not support any particular
         level of sodium in drinking water, and the regulations of
         sodium by a maximum containment level is a relatively
         inflexible, very expensive means of dealing with a problem
         which varies greatly from person to person.29-1

    The basis for the decision not to set an MCL was the fact that  sodium is
only a "hazard" for the small fraction of the population which is especially
    25j  Ibid., p.  82  (emphasis  added).

    2'-'See 45 FR 57322, 40 CFS  141.11 (b).

    21-  Ibid, pp.  114-5.

    2I-  Ibid., p.  116.

    2SJ  Ibid., p.  122  (emphasis  added).

-------
                                   3-23

sensitive to it and must follow a special low-sodium diet.  Setting a
federally-enforceable standard to protect a small segment of the population,
therefore, did not seem an appropriate or justifiable course of action.
Instead, ZPA recommended communities with high levels of sodium in drinking
water supplies to notify consumers of this fact, so that members of the
community with special sensitivities could make other arrangements to acquire
water for drinking.

    Organic pesticides and herbicides were not included in the 1962 Standards
but, as EPA stated in the Preamble'to this proposed regulation, data collected
in the intervening period indicated that:  (1) acute and chronic health
effects on the muscle and nervous systems appear to result from exposure to
certain pesticides; (2) several widely-used pesticides may be possible
carcinogens; (3) no well-documented safe or minimal effect levels had yet been
determined; and (4) considerable additional study was needed before the
effects of these substances in the general environment, and specifically in
drinking water, would be known.  (40 FR 11991)

    At the time the Interim Primary Regulations were proposed, ZPA had
recently cancelled all use of DDT and suspended the major uses of Aldrin/
Dieldrin, exercising its authority under FIFRA.3
-------
                                 EXHIBIT 3-4

                       MAXIMUM CONTAMINANT LEVELS FOR
                    ORGANIC PESTICIDES AND HERBICIDES a/
(a) Chlorinated hydrocarbons:
                                                            MCL, Miligrams
                                                               Per Liter
    Endrir. (1,2,3,4,10, 10-hexachloro-6 ,7-epoxy-I,4,             0.002
    4a,  5,6,7,8, 8a-octahydro-l,4-endo, endo-5,
    3-dimethano naphthalene).

    Lindane (1,2,3,4,5, 6-hexachlorocyclohexane,                 0.004
          isomer) .
    Methoxychlor (1, 1, l-Trichloro-2,2-bis                        0.1
    [p-methoxyphenyl]

    Toxaphane (C.-H1f.ClR -Technical chlorinated                   0.005

    canphene, 67-69 percent chlorine)

(b) Chlsroohenoxys :
    2,4-D, (2,4-Dichlorophenoxyacetic acid.)                     0.1

    2,4,5-T? Silvex (2,4,5-TrichIorophenoxypropicnic acid)       0.1
    a/  The Maximum Contaminant Level (MCLs) apply only to community water
systems.   Community water systems are defined as those which serve "at least
15 service connections used by year-round residents or ... at least 25
year-round residents."  40 C7R 141.2(e)(i).

-------
3-25





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-------
                                   3-26

    In the Preamble to the proposed regulation, the Agency indicated that
although radioactive substances in drinking water supplies were not now a
serious problem, the regulations were necessary, in part, to ensure that the
situation did not become serious:

              EPA recognizes that the normal use of racionuclides in
         medicine and industry and the utilization of nuclear power
         to supply some energy needs will unavoidably lead to some
         radioactivity entering the aquatic environment so that the
         quality of some surface waters is likely to decrease
         slightly in the future.  (40 FR 34324)

Although this increase in radioactivity in drinking water generally would be
small, the Agency believed the risk of future contamination warranted
"vigilance."  Specific MCLs were set for four radioactive substances or
combinations of substances, as listed in Exhibit 3-6.  These substances were
selected for regulation because they were most  likely to be present in public
water systems.

    Several factors were considered in setting  the MCLs for radioactive
substances, including the following assumpicns  and principles:3I*-

         (1)  EPA assumed that no harmless dose of ionizing
              radiation exists; adverse health  effects are assumed
              to be linearly relatd to dose, with no threshold level.

         (2)  The low doses and dose rates expected from the intake
              of drinking water pose only a small potential increase
              over the norsial incidence of certain diseases.

         (3)  The extent of harm resulting from such low doses can
              be extrapolated from the effects  observed at higher
              doses and dose rates.

         (4)  In general, MCLs were selected so as to provide
              uniform protection of individuals at reasonable cost.

         (5)  Where the cost of reducing the potential health risk
              could be calculated, a level of control was selected
              which balanced "reduction in health risks with the
              cost of attaining the desired standard."35J

The last two factors warrant additional discussion, because is it through such
issues as "uniform protection," "reasonable cost" and "risk-cost balancing"
that EPA addresses the question of risk/benefit trade-offs.
    3kJE?A 570/9-76-003, pp.  129-30.

    35-40 FR 34324.

-------
                                   3-27
                                 EXHIBIT 3-6

            MAXIMUM CONTAMINANT LEVELS FOR RADIOACTIVE SUBSTANCZ5



Narurally Occurring:

    Combined radium-226 and radium-228 	  5 pCi/liter

    Gross alpha particle activity
      (including radium-226 but excluding
      radon and uranium) 	 15 pCi/ liter

Produced by Human Activity:

         (a)  The average annual concentration of beta particle and
              photon radioactivity from man-made radionuclides in
              drinking water shall not produce an annual dose
              equivalent to the total body or any internal organ
              greater than 4 tnillirem (mrem)/year.

         (b)  Except for the radionuclides listed in Table A, the
              concentration of man-made radionuclides causing 4 aretn
              total body or organ dose equivalents shall be
              calculated on the basis of a 2 liter per day drinking
              water intake using the 163 hour data listed in
              "Maximum Permissible Body Burdens and Maximum
              Permissible Concentration of Radicnuclides in Air or
              Water for Occupational Exposure, NBS Handbook 69 as
              amended August 1963, U.S. Department of Commerce.  If
              two or more radionuclides are present, the sum of
              their annual dose equivalent to the total body or to
              any organ shall not exceed 4 millirem/year.

Table A.--Average annual concentrations assumed to produce a total body o:
organ dose of 4 mrem/year.
  Radionuclide                  Critical Organ                 per  liter
 Tritium 	 Total body  	 20,000
 Strontium  	'. . . Bone marrow  	       3
Source:  42 CTS. 141.15-16.

-------
                                   J-ZS

    Ir. developing the regulations, EPA considered two possible approaches:
uniform MCLs based on the cost-effectiveness of various levels of risk
reduction, and variable requirements based on the aggregate dose received by
the total population utilising a given public water system.

    Under the first system, EPA would estimate the reduction in health risks
associated with different levels of control, balancing these benefits against
the costs of achieving them, and selecting a single MCL which provided the
best balanceof these two factors.  With the second approach, EPA would
establish differential MCLs, requiring stricter controlsfor water systems
seving larger populations.  Such regulations are likely to be more cost-
efficient because (1) the costs of control can be spread over a large number
of consumers, and (2) greater protection is provided where its effects will be
felt by the most people.

    The Agency chose the first alternative as the basis for the regulations on
"equity considerations" because an aggregate level would have provided for
"varying degrees of health protection."  [40 TR 34325]  "Reasonable cost" was
evaluated on the basis of the estimates provided in Exhibit 3-7.  An MCL of
0.5 pCi/1, which would provide the greatest degree of risk reduction, was
rejected because the annual cost was "considered incommensurate with the
potential risk;" similar arguments were made against the other extremely
strict limits.  Thus, the Preamble suggests that "reasonable" is a flexible
concept, one which is based on a discretionary notion of "balancing" rather
than a strictly-calculated formula or rule.

    Risk estimates were made using data presented in a 1972 report published
by the NAS Advisory Committee on the Biological Effects of Ionizing
Radiation.36-1  Estimates were for the U.S. population in 1967 and indicated,
for example, that the individual risk of a fatal cancer from a lifetime total
body dose, of ^ mrem per year (the MCL for human-made radionuclides) ranged

between .4 to 2 x 10   per year, depending on whether an absolute or relative
risk model was used.  Absolute risk estimates were based on the reported
number of cancer deaths per rad; relative risk estimates on the percentage
increase in cancer mortality per rad.  The NAS Committee did not favor one
model over the other; their "most likely estimates" represent an average of
che cwo estimates.  EPA used these data and risk estimates as guidance to
derive the estimated total number of lives saved per year  for various control
limits, as presented in Exhibit 3-7,

    Naturally-occurring radioactivity.  Based on a sample  of water systems
which had been monitored for radium concentration and the  assumption of a
linear relationship between dose and effect, EPA developed the ifcrmation
presented in Exhibit 3-7 to compare the dollar cost and health savings of
various levels of control.  The MCL of 5 picocuries per liter (pCi/leter) for
    :tJ"The Effects on Populations of Exposure to Low Levels of Ionizing
Radiation," NAS, National Research Council  (NEC):  November 1972.

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                              3-29
                            EXHIBIT 3-7

                COMPARISON OF RADIUM CONTROL LIMITS
Control Limit
pCi Per Liter
9
' 8
7
6
*5
4
3
2
1
0.5
Estimated Number of
Supplies Impacted
240
300
370
450
500
670
800
860
980
1,100
Annual Cost to
Achieve Limit
$ 1,400,000
2,400,000
3,400,000
5,600,000
8,800,000
14,000,000
24,000,000
36,000,000
70,000,000
$100,000,000
                                                       Estimated Total
                                                       Number of Lives
                                                       Saved Per Year
                                                               .6

                                                              1.1

                                                              1.6

                                                              2.5

                                                              3.7

                                                              3 .5
                                                             20
*Level at which regulation was set.

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                                   3-30

radium was selected because EPA believed that "because of the limited data on
the cost of radium removal and the extent of radium contamination in community
water supplies currently available, it would be unwise to prescribe radium
removal at concentrations lower than 5 pCi/liter."37J

    In addition, an MCL was set for gross alpha particle activity, defined as
"total radioactivity due to alpha particle emission as inferred from
measurements on a dry sample."3*-1   EPA justified placing a limit on gross
alpha particle activity rather than each alpha particle-emitting radionuclide
individually because it was impractical, at the time the regulations were
promulgated, to require identification of all such radionuclides because of
the analytical costs which would be incurred.  [p. 134]

    Kuisan-aade Radionuclides.  The major sources of radioactivity created by
human activities are nuclear power plants, medical sources and nuclear weapons
testing.3SJ  The MCL for radioactivity from human activities, 4 millirems
per yars,  was calculated based on the asumed intake of two liters of water per
day.  The 4 millirem standard "was chosen on the basis of avoiding undesirable
future contamination of public water supplies as a result of controllable
human activities .  . . [it] is not anticipated that the maximum contaminant
level for man-made radioactivity will be exceeded except in extraordinary
circumstances."*OJ

    In setting this MCL, EPA pointed out that although "man-aade radioactivity
in public water systems is sometimes a manner of concern, it is important to
recognize that  . .  . current ambient concentrations are less than the proposed
limits because of regulatory concern for these radionuclides .  .  .  [and
because]  .  . . drinking water is not a major pathway for exposure  .  .  .  ."1J

    In addition to human-made radioactivity in drinking water from effluents
discharged by nuclear facilities, surface waters may contain radioactive
substances resulting from airborne releases of effluents and from nuclear
weapons testing.  Of primary concern from these sources are strontium-90 and
tritium and for this reason, EPA adopted specific MCLs for these two sources
of radioactivity.  Although data on the effects of these substances on water
supplies were incomplete, available data indicated that strontium-90
concentrations averaged about 1 pCi per liter (corresponding to a total  body
dose equivalent of less than 0.2 mrem per year).42J  The discussion indicate
    37JE?A 370/9-76-003, p.  136.  Much  of  the discussion  in  this  section
derives from this report,  especially pp. 129-141.

    3'-40 C?R Part  141.2(m).

    3SJ Ibid., p. 130.

    UOJ40 FR 34327.

    uijE?A 570/9-76-003, p.  137.

    "2- Ibid., p. 130.

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                                   3-31

how these ambient concentrations were used to derive the MCLs presented in
Exhibit 3-6.

    Organic Chemicals

    When the Interim Regulations for inorganics and certain organic pesticides
and herbicides were proposed, EPA deliberately deferred promulgating standards
for other organic chemicals, and instead required public water systems to
begin regular monitoring for a number of organic pollutant parameters for
which the Agency was contemplating setting standards, including carbon
chloroform extract (CCS), volatile and non-volatile total organic carbon (V70C
and NVTOC), total organic chlorine (TOC1), ultraviolet absorbancy, and
fluorescence.  The reason for taking this course of action was to gather
additional data on the extent to which organics in drinking water ara a
problem.  In July of 1976, EPA issued an Advance Notice of Proposed Rulemaking
(ANPRM)41J listing several factors about organics and the need for
regulation:

          (1)  Organics (synthetic and natural) are present in all
              sources of drinking water to some extent.  Synthetic
              organics are created by the addition of chlorine (used
              as a disinfectant) to drinking water.

          (2)  Most organic compounds in drinking water have not been
              specifically identified and analysis for many is very
              difficult.

          (3)  Of the identified organics in drinking water, few have
              been bioassayed.

          (4)  Some of the compounds that have been identified are
              "toxicants, mutagens, and teratogens" as indicated by
              animal bioassays conducted at high doses.

          (5)  The effects of long-term, low level exposure on humans
              is not known.

          (6)  Some preliminary studies have suggested but not
              concluded that there is a correlation between cancer
              mortality and the concentration of certain organics in
              drinking water.

          (7)  With the passage of the SCWA, Congress intended that
              "at least some organics in drinking water would be
              regulated."  This intent is made clear in the
              Legislative History which states that:
    *1J41 rS 23991.

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                                   3-32

                  .  .  .  the [Interstate and Foreign Commerce]
              Committee anticipates that revised national primary
              drinking water regulations would include regulation of
              organics as a group and subgroups, such as haloethers,
              polycyclic aromatic hydrocarbons, and nitrosamines
              [Legislative History, p. 6464].

              In addition, Section 1442(a)(10) of the SDWA which
              directs EPA to carry out a study of the "reaction of
              chlorine and humic acids (organic substances) and the
              effects of the contaminants which result from such
              reaction on public health and on the safety of
              drinking water,  including any carcinogenic effect."

         (8)  Treatment for the control of organics is not widely
              practiced in the U.S. and would impose an added
              expense on public water systems.

Given these facts, EPA concluded, a course of action was not clear, although
some action was necessary.  A probable factor in the decision to regulate
organics at that time was a suit filled by the Environmental Defense Fund
(EDF),  pending in the U.S. Court of Appeals, which challenged EPA for not
including regulations for organics in the 1975 Interim Primary
Regulations.**J

    The regulatory options under the SDWA were to establish MCLs for
individual compounds, groups of compounds or general contamination indicators,
and/or to establish technology-based treatment requirements.  EPA articulated
the advantages and disadvantages of the three options in the ANPRM to the
proposed regulations  (at 28995-6).  The main arguments against MCLs for
specific chemicals were limited availability of health data to support
individual limits, the difficulty in isolating and measuring individual
organic chemicals in water, and the cost of monitoring for such a potentially
large number of substances.

    Disadvantages of setting an MCL for a single "general organic contaminant
indicator" are that such indicators are less sensitive measures of contaminant
content, cannot distinguish which organic chemicals might be present, and
cannot be correlated with a direct health effect for purposes of selecting cin
appropriate MCL.

    The major trade-off between the two approaches was the higher cost and
current scientific uncertainty of setting MCLs for specific substances versus
the relative insensitivity and potentially lower level of health protection of
the general indicator strategy.  Technology-based standards were seen as a way
of ensuring that even those organics which could not yet be identified and
monitored would be controlled, although to an as-yet unspecified level.
               Costle, 578 F.2d 337  (D.C. Cir.  1978).

-------
                                   3-33

    EPA published lengthy proposed regulations in February 1978 and  final
regulations were adopted in November of 1979. *SJ   The Interim Regulations
included two requirements:  an MCL of 0.10 mg/1 for total trihalomethanes
(TTHMs) including chloroform,**-1  and a treatment technique requiring the use
of granular activated carbon (GAC) to filter organic materials out of drirJcing
water supplies.  EPA identified a number of factors which influenced the
regulations finally adopted:*7-1

         (1)  Conclusive proof of an adverse health effect is not a
              prerequisite to regulation; available data suggest
              that THMs may have such an effect and therefore
              should be regulated.

         (2)  THMs, especially chloroform, are generally present in
              greater concentrations than other organic chemicals in
              drinking water, thus facilitating feasible monitoring
              and analytical techniques.  Moreover, THMs as a group
              are similar enough to allow a single MCL for total THM
              concentration.

         (3)  The health effects data, including bioassay,
              monitoring, mutagenicity, and epidemiology are further
              developed for chloroform, and by implication for THMs,
              than for other organic chemicals in drinking water.

         (4)  THMs are more ubiquitous contaminants in drinking
              water than other synthetic organics.

         (5)  Several treatment procedures are available for
              controlling THMs in drinking water.

    In addition, EPA utilized principles articulated in the MAS report en
drinking water**-1 in its rationale for these regulations:
    *SJ43 FR 5756 (February 7, 1978) and 44 FR 68624 (November 29,  1979)
respectively.

    *5JIn the final regulations, trihalomethane (THM) is defined as "one of
the family or organic compounds, named as derivatives of methane, wherein
three of the four hydrogen atoms in methane are each substituted by a halogen
atom in the molecular structure."  Total trihalomethanes (TTHMs) refers to
"the sume of the concentration in milligrams per liter of the trihalomethane
compounds (trichloromethane [chloroform], dibromochloromethane,
bromodichloromethane, and tribromomethane [bromofora]), rounded to  two
significant figures."

    *7J43 FS 5763 (February 9, 1978).

    *
-------
                                   3-34

         (6)  Effects in animals, properly qualified, are applicable
              to man.

         (7)  Methods do not now exist to establish a threshold for
              long-term effects of toxic agents.

         (8)  Exposure of experimental animals to toxic agents in
              high doses is a necessary and valid method of
              discovering possible carcinogenic hazards in man.

         (9)  Materials should be assessed in terms of human risk,
              rather than as "safe" or "unsafe."  In its explanation
              of this principle, the NAS report stated that "The
              limitations of the current experimental techniques do
              not allow us to establish safe doses, but with the
              help of statistical methods, we may be able to
              estimate an upper limit of the risk to human
              populations.  To calculate such a risk, we need data
              to estimate population exposure; a valid, accurate,
              precise and reproducible assay procedure in animals;
              and appropriate statistical methods.**J

    The actual MCL of 0.10 mg/1 was based on a "balancing of public health
considerations and feasibility of achievement."s°J   The phasing-in approach
used in the required treatment protion of the regulations is a further
indication of EPA's attempt to balance the benefits of reduced risk to human
health against the cost of achieving this reduction.

    That EPA has stayed within its legal mandate in developing and proiaulating
drinking water regulations is evidenced by the decision in EDF v. Costle,
cited above.  In its decision of February 10, 1978, the U.S. Court of Appeals
for the District of Columbia "found that EPA could exercise a degree of
administrative discretion in deciding whether to control organic chemical
contaminants under the NIPDWR."51J  The Court deferred final resolution of
the issue, however, by remanding the record to EPA to report on "significant
changes that have occurred, since the promulgation of the interim regulations,
in [SPA's] assessment of the problem of controlling organic contaminants  in
drinking water" and to advise the Court "as to whether its plans to propose
amended interim regulations in light of newly acquired data."

    Thus, although EPA's future discretionary authority remains intact, it is
likely to be carefully scrutinized by third party interest groups and, by
extension, the Courts.
    *'JNAS, Drinking Water and Health, p. 56.

    58-43 75 5764.

    sl-578 ?.2d 337.

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                                   3-35

    Secondary Drinking Water Regulations

    The purpose of secondary regulations, to "protect the public welfare," is
both less immediate and less difficult to fulfill.  The SBWA mandated,
therefore, that final secondary standards be established quickly, based on
available data.  While the standards refer to either specific substances or
specific drinking water quantities, they are necessary only for aesthetic
rather than human health considerations.

    Specification of Substances Regulated.  Secondary regulations must
specify  'contaminants in public water systems" but are to cover only those
contaminants "which may adversely affect the odor or appearance of such water
... or ...  which may otherwise affect the aublic welfare."  The sole
reference to possible effects of these contaminants is that they "consequently
may cause a substantial number of the persons served by the public water
system ... to discontinue its use."

    Status of the Regulations.  Secondary drinking water regulations to
"protect the public welfare" were promulgated on July 19, 1979.S2j   The
regulations identified several known contaminants of drinking water supplies
and established non-enforceable "guidelines" to assist States in keeping these
contaminants at a level which minimizes their undesirable effects.   These
limits are presented in Exhibit 3-8.

    In general, the effects caused by a contaminant which specify it as one
requiring secondary regulation are discoloration, bad odor or unpleasant
taste, staining of laundry or plumbing, or certain mild but unpleasant health
effects.   Exhibit 3-9 indicates the qualities of the various contaminants
which caused them to require secondary regulation.

SUMMARY

    The SDWA delegates considerable discretionary authority to EPA as to which
chemicals will be regulated and the type of regulations that will be imposed.
The standards promulgated to date indicate that EPA has indeed taken a
flexible approach in setting the interim primary drinking water regulations.
Moreover, on the basis of these regulations, some general comments can be made
about the way in which EPA has exercised its authority under the SDWA.

    The Agency has followed a fairly conservative srraragy with ras-oecr ~o
previously-regulated contaminants.  With the few exceptions noted earlier,
the guidelines set forth in the 1962 Standards remain unchanged by the 1973
Interim Primary Regulations.  To a large extent, the decision not r.o change
the standards represents the fact that data obtained since 1962 has tended to
sunoort the concentration limits sat at that time.
    SZ-144 FR 42195.

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                                   3-36



                                 EXHIBIT 3-8

                    SECONDARY MAXIMUM CONTAMINANT LEVELS
                Contaminant

                 Chloride
                 Color
                 Copper
                 Corrosiviry
                 Foaming Agents
                 Iron
                 Manganese
                 Odor
                 pH
                 Sulfate
                 Total dissolved solids (TDS)
                 Zinc
  Level

250 mg/1
15 color units
1 mg/1
Noncorrosive
0.5 mg/1
0.3 mg/1
0.05 mg/1
3 threshold odor nuaibe:
6.5-8.51
250 mg/1
500 mg/1
5 mg/1
Source:  40 CFR 143.3
                                 EXHIBIT 3-9

            EFFECTS OF CHEMICALS REGULATED 3Y SECONDARY STANDARDS
                             TYPE OF UNDESIRABLE EFFECT
   Chemical

Chloride
Copper
Corrosiviry
Foaming Agents
Hydrogen Sulfide
Iron
Manganese
Sulfate
Total Dissolved Solids (TDS)
Zinc
Bad
or








i)

Odor
Taste
X
X

X
X
X
X
X
X
X
Causes
Stains


X

X
X




Discolors
Water



X

X


X
X

Other


Dissolves metals
"Unaesthetic"



Laxative effect



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                                   3-37

    It can also be seen, however, as an indication that EPA considers such
regulations to be adequate and the pollutants in question not to warrant
excessive time and resources spent reviewing them extensively.  While this
sentiment is nowhere expressed directly, it is apparent that these, the more
traditional drinking water contaminants, are not the major concern of either
the Agency or the scientific community in general at this time.  Major
emphasis, for several years to come, is likely to focus on the expansion and
revision of the regulations controlling organic chemicals.

    The Agency has employed a conscious cost-effectiveness approach to
regulating potential carcinogens.  From this perspective, the recently-
promulgated THM regulations provide the most telling indication of how the
Agency is likely to handle low-level, long-term exposure to carcinogens in
drinking water.  On the one hand, conclusive proof of carcinogenicity is not
to be required as a prerequisite for regulation, the "threshold" concept has
been repudiated, and high dose, short-term animal studies have been supported
as "necessary and valid" test methods.  On the other hand, however, the Agency
has explicably stated its intention to balance the benefits of reduced risk to
human health against the cost of achieving this reduction.  The estimates
developed to compare various levels of control for radium (Exhibit 3-7)
provide a tangible example of this type of balancing effort.  The approach has
not been (and is not likely to be in the future) wholly consistent across
chemicals.  (An indication of this inconsistency is the different margins of
safety or "safety factors" used in calculating various MCLs.)  The differences
reflect the significant disparities in data bases, monitoring ability, and
level of knowledge which can be brought to bear on the regulatory process.  It
is unlikely that these disparities will decrease significantly at any point in
the near future.

    The ability to identify and measure contaminants in drinking water is a
critical constraint.  Although this fact is never articulated in any formal
way, EPA personnel have stated that it is a primary determinant in specifying
chemicals for possible regulation under the SDWA.  Setting a standard for
total trihalomethanes rather than for several specific compounds is a recent
indication of how human health considerations may be constrained by as-yet
imperfect scientific methods.

    The control of organic chemicals is clearly the major effort EPA will be
making in the drinking water area over the next several years, for two key
reasons.  On the one hand, available data indicate that such chemicals are
likely to be highly toxic as well as carcinogenic and mutagenic, though data
on dose-response levels are still insufficient.  On the other, scientific
methods for identifying and detecting all of these substances are presently
inadequate and will require considerably more research.  The Agency itself
acknowledges the continued emphasis on organic contaminants in the proposed
TTHM regulations:

         ... an MCL of 0.10 mg/1 for TTHM has been proposed  ... as a
         reasonable level providing health protection to the extent
         feasible.  This should not lead to complacency on the part of
         [public drinking water] systems with a THM of 0.09 mg/1 for
         example, but should be construed only as a starting point which
         will, over time, be lowered progressively as technologic,
         economic and practical contrainsts permit.  (43 ?R 5763)

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         MARINE PROTECTION, RESEARCH, AND SANCTUARIES ACT (MPRSA) --
                              STATUTORY REVIEW
BACKGROUND

     This act, commonly known as the Ocean Dumping Act of 1972,: was de-
signed to fill regulatory gaps in the protection of the marine environment and
public health.  Rather than designate specific materials to be regulated, the
statute declares all materials dumped in ocean waters to be regulated
substances.

     Publicity in 1970 over the dumping of herbicide compounds and nerve gas
rockets once intended for chemical warfare made Congress aware of the need for
more protection of ocean waters.  A 1970 CEQ study2 pointed out the gaps in
the regulation of ocean waters, supplied data on the large quantities of mate-
rial then being dumped, and discussed the hazards of ocean dumping.  This
study also served as the basis for the congressional development of  legisla-
tion which gave EPA discretionary authority to regulate ocean dumping.

REGULATORY CRITERIA

     Section 102(b) declares it the Congressional policy "to regulate the
dumping of all types of materials into ocean waters and to prevent or strictly
limit the dumping into ocean waters of any material which would adversely af-
fect human health, welfare, or amenities, or the marine environment, ecologi-
cal systems, or economic potentialities".3

     The definition of the word "material" is all-inclusive:

     "Material" means matter of any kind or description, including,
     but not limited to, dredge material, solid waste, incinerator
     residue, garbage, sewage, sewage sludge, munitions, radiologi-
     cal, chemical, and biological warfare agents, radioactive mate-
     rials,  chemicals, biological and laboratory waste, wreck or
     discarded equipment, rock, sand, excavation debris, and incus-
     trial,  municipal, agricultural, and other waste; but such tera
     X23 USC §1401 et seq.  The MPRSA preempts state regulations.  Save
Our ?isheries Assoc. v. Callaway. 7 ESC 1445 (R.I. 1974).

     ^Senate Report 92-451, as cited in 1972 U.S. Code Congressional and
Administrative News, p. 4234.

     333USC §1401 CD).

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                                   4-2
     aoes net mean sewage from vesseis within the meaning of section
     212 of the Federal Water Pollution Control Act, as amended (33
     Radiological, chemical, and biological warfare agents, and high-level
radioactive wastes, are never permitted to be dumped.5  For other mate-
rials, EPA is delegated authority to grant permits to transport for dumping
"where the Administrator determines that such dumping will not unreasonably
degrade cr endanger human health, welfare, or amenities, or the marine envi-
ronment, ecological systems, or economic potentialities".  EPA is authorised
to establish "criteria" upon which to evaluate permit applications.

     The MPRSA provides that in establishing or revising ocean dumping permi
criteria the EPA shall consider at least the following factors6:

     (A)  The need for the proposed dumping.

     (3)  The effect of such dumping on human health and welfare,
          including economic, esthetic, and recreational values.

     (C)  The effect of such dumping on fisheries resources, plank-
          ton. fish, shellfish, wildlife, shore lines and beaches.

     (D)  The effect of such dumping on marine ecosystems, particu-
          larly with respect to

            (i) the transfer, concentration, and dispersion of such
                material and its byproducts through biological, phy-
                sical, and chemical processes;

           (ii) potential changes in marine ecosystem diversity,
                productivity, and stability; and

          (iii) species and community population dynamics.

     (?)  The effect of dumping particular volumes and concentra-
          tions of such materials.
     "Section 103(c); 33 USC §140i(c).  Oil within the meaning of Section
311 of the Federal Water Pollution Control Act, as amended (33 USC §1321),
shall be included only to the extent that such oil is taken on board a vessel
or aircraft for the purpose of dumping.

     sHigh level radioactive wastes are defined in USC §1402(j).

     'Section 102a.

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                                   4-3
     (E)  The persistence and permanence of the effects of the dump-
          ing.

     (G)  Appropriate locations and methods of disposal or
          recycling, including land-based alternatives and the prob-
          able impact of requiring use of such alternate locations
          or methods upon considerations affecting the public in-
          terest.

     (H)  The effect on alternate uses of oceans, such as scientific
          study, fishing, and other living resource exploitation,
          and nonliving resource exploitation.

     (I)  In designating recommended sites, the Administrator shall
          utilize wherever feasible locations beyond the edge of the
          Continental Shelf.

     These factors need not result in criteria which must be applied in every
case.  Rather, the EPA can weigh and consider these factors and need not in-
clude them all in its criteria.  This was established by the case discussed
next.

     A recent Appeals Court case reviewed a challenge to EPA's authority to
establish different and less stringent criteria for dumping dredged wastes
than for non-dredged materials.  The Court held that the MPRSA gives "unquali-
fiedly broad authority to the [EPA] Administrator to weigh and consider the
evaluation factors" in developing criteria for permits.  The EPA has the
authority "to conclude that certain statutory evaluation -factors ars inappli-
cable to a class or type of material".  Based on the statutory language and a
review of the legislative history, the Court found that EPA had sufficient
discretion to determine that, in certain respects, dredged wastes differ sig-
nificantly from nondredged wastes.7  However, the Court remanded the regu-
lations to EPA for further action because the government had failed to ade-
quately explain its rationale for disparate treatment of the two categories
of wastes.

     The agency has much discretion in issuing permits so long as the criteria
are not violated.  For example, in one case, the Corps of Engineers issued a
dumping permit based on (1) pooling and averaging the results of bioassay mor-
tality tests and (2) a 10 percent level for determining what mortality rate
     National Wildlife Federation v.Costle. 14 ERC 1680,1692 (D.C. Cir.
1980).  The Court wanted EPA to explain why dredged materials were exempted
from restrictions on oxygen-consuming constituents and microorganisms, and
subject to less extensive testing procedures, less stringent site design
criteria, and less stringent site evaluation procedures.  Id., at 1694.

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represents a significant undesirable environmental effect.  A reviewing court
upheld the permit because these interpretations of the permit criteria were
not plainly erroneous or arbitrary and capricious.*  Thus, so long as a
permit decision is rational and does not violate the permit criteria, it will
probably be upheld in'the courts.

     EPA's permitting authority covers the dumping of all types of materials
into ocean waters.  The Corps of Engineers, however, has partial authority
over permits for the dumping of dredged materials.  The Corps receives permit
applications for dredged materials and reviews them using EPA's criteria for
evaluation cf materials.  EPA, however, has final authority over all dumping
permits.*

SUMMARY

     In short, this statute declares all dumping prohibited unless EPA permits
it, or. the basis of criteria to be administratively established, taking into
account its effects on "human health, welfare, or amenities, or the marine
environment, ecological systems, or economic potentialities" (33 USC §1401(b)
and the need for dumping.  Dumping of those materials considered to have
unreasonable adverse effects is rarohibited.
     'National Wildlife Federation v. 3enn, 491 F. Supp.  1234  (S.D.N.Y.
1980).

     'Section 103, 33 USC  §1413.

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                                   4-5
     MARINE PROTECTION RESEARCH AND SANCTUARIES ACT -- REGULATORY REVIEW
INTRODUCTION

     This review summarizes the regulations promulgated under Section 102 of
the Marine Protection Research and Sanctuaries Act through January 1, 1981.
The regulations cover the control and permitting of ocean dumping.  The
following topics are covered:

          •    Summary of Regulations--provides a brief
               condensation of the history and content of the
               regulations dealing with the dumping of both dredged
               and nondredged material in U.S. territorial seas.

         • •    Permitting Criteria--describes the materials
               prohibited and allowed for ocean dumping, and the way
               in which these are classified and determined.

SUMMARY OF REGULATIONS

     The Marine Protection and Research Sanctuaries Act (MPRSA) Secton 102
declared that "it is the policy of the United States to regulate the dumping
of all types of materials into ocean waters and to prevent or strictly limit
the dumping into ocean waters of any material which would adversely affect
human health, welfare or amenities, or the marine environment, ecological sys-
tems, or economic potentialities".1

     Regulations promulgated under this act reflect the comprehensive nandate
given to EPA to regulate "all types of materials".  Consequently, all material
to be dumped is automatically prohibited unless the dumper can obtain a
permit.  The process and criteria by which an applicant can prove that ocean
dumping is not only necessary, but will not have unacceptable adverse effects
on the marine ecosystem, human health, or other uses of the ocean, is the
substance of the regulations.

     EPA first published ocean dumping regulations in 1973.2  Since then,
some major changes have been made.  Exhibit 4-1 summarizes the regulatory
history.
     133 USC §1401(b).

     238 FR 28610 (Oct. 15, 1973) Final Rules.

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                                 EXHIBIT 4-1

                            REGULATORY CHRONOLOGY


1972           Marine, Projection, Research and Sanctuaries Act enacted

Spring 1973    EPA publishes interim permitting regulation, and interim cri-
               teria for the evaluation of permits

October 1373   Final Regulations promulgated (40 FR 28610, October 15, 1973)

March 1974     MPRSA amended to bring Act into full compliance with the Inter-
               national Convention or. the Prevention of Marine Pollution by
               Dumping of Wastes and Other Matter (P.L. 93-254)

June, 1976     Proposed Revised Regulations and Criteria for Permitting pub-
               lished (41 FR 23544, June 18, 1976).  Draft EIS on the permit-
               ting criteria issued (EPA, June 14, 1976) for public comment

October, 1976  EPA holds a technical workshop dealing wih the trace contami-
               nant and dredged material criteria to obtain recommendations
               for revised criteria (October 19-20, 1976)

January, 1977  Final Revised Regulations and Criteria published (42 FR 2642,
               January 11, 1977)

November, 1977 MPRSA amended (P.L. 95-153) to prohibit all dumping of harmful
               sewage sludge after December 31, 1981

October, 1980  Final Regulations and Criteria published (45 FR 65942,
               October 3, 1980)

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                                   4-7
     The MPRSA was amended in 1974 to agree procedurally and legally with the
International Convention on the Prevention of Marine Pollution by Dumping of
Waste and Other Matter.  The regulations under MPRSA must be at least as
stringent by law as the Convention5.  The Convention lists several
categories of prohibited and limited materials for ocean dumping in such the
same way as U.S. ocean dumping regulations.  However, the Convention does
require special care and testing for very specific categories of waste
constituents not directly mentioned in U.S. regulations, including
constituents such as lead, chromium, organosilicon compounds, cynanides, and
pesticides.  Although U.S. regulations do not discuss these substances
specifically, their effects would be measured in the required bioassay and
bioaccumulation tests, as well as through the application of the Convention.

     Final regulations published approximately one year after MPRSA was
amended contain permitting criteria applicable to both (1) ocean dumping and
(2) ocean discharges, which are regulated under Section 403(c) of the Clean
Water Act (See 40 CFR 122).*  Because of administrative problems, and
because the criteria were primarily focused upon the dumping of transported
waste materials, EPA published two sets of criteria, both revised, as separate
regulations.  Ocean discharges now require an National Pollutant Discharge
Elimination System (NPDES) permit and must conform to ocsan discharge
criteria.  These criteria, final rules, were promulgated in October, 1980.5
The discharge criteria are designed to prevent "unreasonable degradation of
the marine environment."  The criteria require similar considerations as the
ocean dumping criteria, including significant adverse changes in the
biological community, the threat to human health through toxic and/or
bioaccumulative wastes, and the esthetic, recreational, scientific, and
economic effects of the discharge compared to its benefits.

     In October 1977, a controversial amendment (P.L. 95-153) to MPRSA was
enacted that prohibits disposal of harmful "sewage sludge" after December 31,
1981.'  The amendment was introduced because of particular pollution prob-
lems along the East Coast, including the closing of beaches along Long Island
     '33 USCA §1412(a).

     "42 FR 2462 (January 11, 1977), Final Revision of Regulations and
Criteria.

     *45 FR 65942 (October 3, 1980), Final Rules.

     'Public Law 95-153.  Section 4 defines "Sewage sludge" as any "solid,
semisolid, or liquid waste generated by a municipal wastewater treatment
plant, the ocean dumping of which may unreasonably degrade or endanger human
health, welfare, amenities or the marine environment, ecological systems, or
economic potentialities."

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                                   4-8
and a massive fish kill on the Mid -Atlantic; coast in 1976.  There was also
continuing concern by the Congress (Merchant Marine and Fisheries Comxittee,
House of Representatives) that EPA was not enforcing MPRSA adequately.7  The
committee felt that EPA was overusing interim permizs ,  not establishing firm
phase-out dates for -dumping, and continuing to permit materials unable to meet
the environmental impact criteria.  EPA opposed the amendment, saying that it
was administratively inflexible and economically infeasible.  Despite these
objections, the amendment was passed.  After December 31, 1981, no "harmful
sewage sludge" may be dumped, and, as published in the regulations, no permits
will be issued for materials that do not meet the environmental inroact
criteria."

     The controversy surrounding this mandate also stems from the municipali-
ties involved:  populous East Coast cities or counties, with severe fiscal
problems, which must come up with alternative land disposal sites.  The
municipalities still operating under interim permits, only three in 1980, are
being forced to curtail dumping or use designated dumps ites much farther out
to sea than previously used.  New York City, in fact, has brought suit against
EPA, claiming that the environmental criteria are too stringent in light of
data on dump sites collected by EPA and NOAA and the environmental and
monetary costs of land-based methods.  Although the dumping of sludge has many
potential adverse effects, including heavy metal loading, degradation of
coastal water quality through pathogens, and toxicity to marine organisms, the
accumulating data from monitoring dumpsites may require changes in dumping
limitations.  Since the amendment bans only the dumping of "harmful" sewage
sludge that may unreasonably degrade the marine environment or endanger human
health, dumping may still be allowed after December 31, 1981 if the criteria
upon which that determination is made are changed, or if some sludges can meet
the -resent criteria.
     EPA has set up a regulatory approach to ocean dumping with several  levels
of control, the ultimate purpose being "to regulate the dumping of ail types
cf materials into ocean waters".'  All materials to be dumped require a
permit.  Except for those wastes generally approved for dumping, all wastes
must aeet the environmental need, and economic and social impact criteria
reviewed below.   The burden of proof rests with the applicant to show that
     7U.S. Code Cong, and Admin. Mews  1977, p. 3262.  Although the beach
closings and fish kills were shown later not to be directly caused by sludge
dumping, they still brought public attention to ocean pollution problems.

     "40 CFR 220.3(d).

     933 USC §1401(b).

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                                   4-9
"the disposition of materials into the territorial seas or contiguous zone"
(definition of dumping) "will not unduly degrade or endanger the marine
environment".1'  The criteria described below, including the environmental
impact criteria and other necesary criteria used to evaluate proposed dumping,
are applied on a case-by-case basis from information available to the
applicant, SPA, or the Corps of Engineers.

ENVIRONMENTAL IMPACT CRITERIA

     These specific criteria form the basis for the applicant to show that the
proposed disposal of either dredged or non-dredged material does not have sig-
nificant adverse environmental impacts.  EPA regulations evaluate materials by
setting up five categories:11

          1.   Materials that are prohibited (40 CFR 227.5)

          2.   Materials that contain certain constituents prohibi-
               ted except as trace contaminants (40 CFR 227.6)

          3.   Materials allowed only under certain limitations (40
               CFR 227.7)

          4.   Wastes that may generally be appproved for dumping
               (40 CFR 227.2).

          5.   Dredged Materials (40 CFR 227.13).

     1.   Prohibited Materials.  The ocean dumping of the1 following materials
is prohibited and will not be approved for dumping under any circumstances:

          •    High-level radioactive wastes12
     Ia40 CFR 220.2(e).  "Dumping" is defined in the regulations as any
disposition of material provided that it does not encompass several.
exceptions including:  effluents from discharges covered by the Clean Water
Act, Rivers and Harbor Act, or Atomic Energy Act of 1954, routine effluents
from vessels; the construction of artificial islands or intentional placement
of any device, oyster shells, fish wastes, or any other material for fisheries
development.

     1140 CFR 227.5 - 227.13.

     1240 CFR 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 fuel or irradia-
ted fuel from nuclear power reactors.  All other radioactive wastes aust be
properly containerized as defined in 40 CFR 227.11.

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                                   4-10
          •    Materials produced or used for radiological or
               biological warfare

          *    Persistent inert synthetic or natural materials
               which may float or remain in suspension in such a.
               manner that might interfere with fishing, navigation
               or other uses of the ocean.

          •    Materials insufficiently described by the applicant
               to effectively evaluate the application on the basis
               of the environmental impact criteria.

     2.   Trace_Contaminar.ts.  The prohibited materials above are relatively
clear cut and easily distinguishable.  Materials containing the constituents
below, which are prohibited other than as trace contaminants, are more  diffi-
cult to define and quantify:13

          •    Mercury and its compounds:"

          •    Cadmium and its compounds

          •    0_-ganohalogens, (for example:1* DDT. Chloroform,
               methylchloride, ?CBs, trichloroethylene, many others)

          •    Oil and greases

     The term "trace contaminants" was used primarily to agree with the
International Convention.  The final regulations do not really define trace
contaminants, they merely describe what is acceptable for ocean dumping:
     1340 CFR 227.6

     l*Preambie to the Final Rules, 42 FR 2466  (January  11  1977).  Mercury
is an exception to the limiting permissible concentration explained below.
Because mercury levels fluctuate, and because the marine water quality  cri-
teria are set near the lowest ambient levels observed, the  mercury concentra-
tion may exceed the average normal ambient concentration, after  initial
mixing, by not more than 50% in the liquid phase.

     iSThese are not  listed in tiie ocean dumping regulations, but are exam-
ples taken from the list of criteria toxic pollutants designated at 40  CFR
401.15 pursuant to Section 307(a) of the Clean  Water Act.   Approximately  half
of this list are organohalogens.

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                                   4-11
          Those quantities that are in such form and amount that the
          dumping will not cause significant undesirable effects,
          including the possibility associated with their bioacsumu-
          lation in organisms.

     The determination of "those quantities" rests on data that can predict
the constituents' effects on the marine ecosystem.  As stated in the preamble
to the final rules:  "The test to be applied en all wastes is the direct de-
termination of the impact of these consitutents present in a waste on the
marine ecosystem as measured by bioassy techniques."15  This method is con-
sistent with an ecosystem approach and yields a more accurate assessment of
the materials impact than comparing total amounts of specific constituents
with arbitrary ambient values.  Bioassay and bioaccumulation testing, however,
is a new field, at least for the suspended particulate and solid phases, and
requires special guidelines and a case-by-case evaluation.  Bioassay proce-
dures are used to set the "limiting permissable concentration" that makes up
the monitoring parameter for specific constituents.

     The trace contaminants listed above, or any other toxic waste, as direc-
ted in 40 CTR Section 227.8 ( Limitations on the disposal of toxic wastes),
cannot exceed its "limiting permissable concentration'.   The definition of
limiting permissable concentration is central to the application of the regu-
lations.17  Liquid, suspended particulates and solid phases of the material
to be dumped each have a limiting permissable concentration for the particular
constituent determined by its effect on the marine environment.  The applica-
tion of limiting permissible concentation is shown in Exhibit 4-2.

     For those materials listed as prohibited other than trace contaminants,
the specific bioassay requirements do not apply if the applicant can demon-
strate that the constitutents are present in a form that is non-toxic and non-
biocumulative to the marine environment, or will be rapidly rendered so in the
marine environment by biological or chemical degradation.  However, the pres-
ence of these materials cannot make edible marine organisms unpalatable, or
endanger the health of humans, domestic animals, fish, shellfish, or wild-
life.1*  For any waste materials with uncertain or unqualified effects the
bioassay and bioacummulative tests are required.

     As demonstrated by the definition above, EPA has great leeway in identi-
fying trace contaminants and their allowable concentrations.  For example, as
indicated in the regulations, if EPA or the Corps of Engineers has "resonable
     1!Preamble to the Final Rules, 42 FS 2462-2467 (January II, 1977).

     1 Definition of limiting permissible concentration (L?C) 40 CFR 227.27.

     1S40 CFR 227.6(f).

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                                 EXHIBIT 4-2

                     LIMITING PERMISSIBLE CONCENTRATION


Phase         Ccncer.-ration of Waste Constituent, after Initial Mixinglj

Liquid        May not exceed applicable marine water quality criteria.2J

               If there are no applicable criteria, will not exceed 0.1 of a
               concentration shown Co be acutely toxic to appropriate
               sensitive marine organisms.3-1

Suspended      Will not cause unreasonable acute or chronic toxicity or
participates   accumulation of toxic materials.  This is determined through
and solic.s     bioassay and bio-accumulation tests using appropriate
               sensitive marine and benthic organisms.
     '•-'40 CFR 227.20 defines initial sixing based on a mathematical or other
theoretical model.

     1J 40 C7R 227.3 defines applicable marine water quality criteria  as the
standards published by EPA in "Quality Criteria for Water" as published in
1976, with subsequent amendments.

     3-"Appropriate sensitive marine organisms" are explained and specified
at 40 CTE 227.31 with the definition of limiting pernissable concentration.
The factor of 0.1 is a standard figure used to extrapolate laboratory results
to approximate field conditions.  If there is field data that supports the use
of a different toxicity factor, then a factor different than 0.1 will be  re-
quired.  Z?A has published, and is in the process of revising, bioassay manu-
als for both dredged and non-dredged materials that delineate the exact proce-
dures .

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                                   4-13
cause to believe" that a material proposed for ocean dumping contains carcino-
gens, mutagens, or teratogens which are not covered in the criteria, then they
may require special studies before the issuance of a permit.13  Potential
toxic constituents are dealt with on a case-by-case basis, following bioassay
procedures outlined in manuals published by EPA and the Corps of Engineers for
dredged, municipal, and industrial wastes.  These manuals, as well as the cri-
teria, are in the process of being revised.

     3.   Other limited materials.  Certain constituents are also limited in
their concentrations and impacts.  These materials are as follows:23

          •    Liquid waste constituents immiscibla or slightly
               soluble in water, such as benzene, xylene, carbon
               disulfide, and toluene, may be present only below
               their solubility limits in seawater, as long as they
               do not interact with ocean water to form insoluble
               materials.

          •    Radioactive wastes, if not prohibited as
               high-level radioactive waste, must be safely
               containerized.2l

          •    Wastes containing living organisms are prohibited
               if the organisms would endanger human or domestic
               animals health.

          •    Highly acidic or alkaline wastes require special
               care.  After initial mixing, the waste cannot change
               the total acidity or alkalinity of the ocean water by
               more than 10 percent.

          •    Biodegradable wastes which consume oxygen may be
               dumped only in quantities which will not depress nor-
               mal dissolved oxygen levels by more than 25%.
     1'40 CT5 227.6(d).

     2"40 CFR 227.7.

     2140 C5U 227.11 describes the requirements for containerised wastes.
The most prominent requirement is that the containers must last as long as the
material takes to radiodecay.  Additionally, the material, if it does leak or
escape, may only cause short term localized effects.  Because cf the lack of
proper containers, and the long term effects of radioactivity, no dumping of
radioactive wastes is allowed at this time.

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          *    Insoluble wastes (such as scrap cr large
               quantities of inert materials) may nor be dumped in
               quantities that might interfere with other uses of
               the ocean such as fishing or swimming.

     <*.    Generally Harmless Wastes.  Wastes that aiay generally be approved
consist primarily of certain classes of dredged materials that are described
below.  Other types of materials usually approved of are small quantities of
materials believed to be harmless, or special categories such as burial-at-sea.

     5.    Dredged Materials.  Because of the quantities and types of
materials generated by dredging, they are treated somewhat differently than
municipal or industrial wastes.12  Dredged materials included in the
following categories do not require further testing and are generally approved
of for dumping:23

          •    sand, gravel, or other bottom material larger than
               silt;

          •    material dredged for beach nourishment or
               restoration;

          •    material that is substantially the same as the sub-
               strate as long as there are no known historical
               sources of pollution at the dredging site.

Most dredged materials (approximately 70%), are included in these three cate-
gories.   All other materials require further testing and characterization,
including the bioassay tests required for municipal and industrial wastes.

N~Z3 AND IMPACT CRITERIA

     Besides the environmental impact criteria, the applicant must also meet
several other sets of criteria that show the necessity for dumping and the
potential adverse effects on other uses of the ocean.  Tnese are not just phy-
sical criteria, but deal with policy options.  If the materials proposed  for
ocean dumping meet the environmental impact criteria, then the permit will be
issued unless:2"
     2ILitigation has established EPA's authority to promulgate different
criteria for dredged and non-dredged materials but the case also held that EPA
had not adequately explained why dredged materials should be subject to  less
stringent requirements.  National Wildlife Federation v. Costle, 11 ERG  1680,
(D.C. Cir. 1980).

     23iO CTS. 227.13.

     :"40 CFR 227,2.

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                                   4-15
          •    There _is no need for ocean dumping.  The applicant
               must show that he has considered other options (e.g.,
               landfill, recycling, incineration, etc) and the
               environmental and economic costs of each.
               (40 CFR 227.14)

          •    The dumping of the material would cause
               "unacceptable adverse effects" on economic, aesthetic
               or recreational values.   These would include the
               potential for affecting beaches or shorelines,
               commercial fishing, or other municipalities or
               industries.  (40 CFR 227.17)

          •    The proposed disposal of the material would have
               "unacceptable adverse effects" on other uses of the
               ocean and coastal areas; for example, scientific
               research or oil and gas exploration.  (40 CFR 227.20)

If the proposed disposal of materials does not meet any one of the above con-
siderations, or the environmental impact criteria (only before December 31,
1978), the applicant may apply for an interim permit.  Besides the limitations
on the type of materials dumped under interim permits, the applicant must also
show that the need for ocean dumping is greater than the potential adverse
effects on economic, aesthetic, or recreational values, or the marine environ-
ment.

     The purpose of these other criteria, each described in mors detail in a
section of the regulations, is to insure that there is consideration of eco-
nomic and social factors in the decision to allow ocean dumping.  In general,
they apply another set of restrictions to the permitting process, that is:  if
the materials meet the environmental impact criteria plus if the dumping
meets the criteria described above, then a permit will be issued for dumping.

DUMPING PERMIT PROGRAM

     The ocean dumping program consists of site designation, permitting, and
surveillance and enforcement.  Site designation must take into account the
geographic placement of the site, waste dispersal characteristics, and inter-
ference with other uses of the ocean.25  The parameters used in desig-
nating and monitoring dumpsites for both dredged and non-dredged material in-
clude, at a minimum:  location, depth, currents, water quality, potential ac-
cumulation of dumped constituents, historical uses of the dumpsita, and the
composition of the biota present.  The background or ambient levels of certain
constituents, particularly heavy metals, are especially important since these
     2S40 CFR 223.

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values will affect the limitations on added increments from dumping.  Beth EPA
and NGAA (which administers Title II of MPRSA, that calls for an ocean re-
search and monitoring program) take on the burden of researching, designating
and monitoring dump sites.  Surveillance, enforcement notice and safe waste
transport responsibilities are given to the Coast Guard.

     Although the criteria and procedures for designating dump sites and ob-
taining dumping permits are different, the two categories are inseparable,
considering the interaction between dumped material and the marine environ-
ment.  Dumping permits are issued by both the Corps of Engineers and EPA for
dredged and non-dredged material, respectively.  Six categories of permits
cover disposal of materials in the ocean:

          (1)  General, (2) Special, (3) Interim, (A) Emergency, (5)
               Research and (6) Incineration at Sea.

     Applications for permits must include all information necessary to evalu-
ate the application.   At a minimum, they must include, besides general infor-
mation, a detailed physical and chemical analysis of the waste materials,
including results of bioassay or other tests required to apply the impact cri-
teria.  The application to EPA or the Corps of Engineers must also include the
following:   the proposed dumpsite, times and amounts of material dumped, a
description of the way in which this material has previously been disposed of,
identification of the process or activity generating the wastes, the method of
release of the materials, and an assessment of the environmental impact of the
proposed dumping.2'

     General permits are issued for disposal of small amounts of generally
harmless wastes.  Holders of special permits, which include municipal, indus-
trial and dredged material dumpers, must meet the environmental impact cri-
teria.  Interim permits, good for only one year, must indicate either a com-
pliance schedule showing a phase out of dumping or compliance with the
environmental impact criteria by 1981. Most dumpers of industrial wastes and
municipal sewage sludge have been operating under interim permits since the
revised regulations of 1977 due to their inability to meet the criteria.  An
interim permit, which may not be issued to any new dumpers, may not include
any prohibited materials or those classified as trace contaminants only.
Additionally, the dumper must demonstrate a need for dumping and the potential
adverse effects on other uses of the ocean.  The other three classes of per-
mits, emergency research, and incineration at sea, are issued on a limited,
case-by-case basis.

     Dredged material permits administered by the Corps of Engineers  (same
categories as above), are issued for private firms, and state and local agen-
cies.  Approximately ninety-five percent of the dredged material generated in
       '40 C7R. 225.1.

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                                   4-17
the U.S. is from Corps of Engineers projects.27  Although the Corps cannot
issue permits to itself, under the 1977 amendment and Corps agency policy,
Corps projects' dredging spoil must go through the same critical process as
private firms and muncipalities.   Dredged material is dumped at sites
designated by EPA specifically for dredged material.

SUMMARY

     The greatest dangers to human health and welfare from ocean dumping are
the potential effects of bioaccumulation and ingestion of toxics or carcino-
gens through the human food chain.  Examples would include the accumulation of
heavy metals like mercury and its compounds in fish and shellfish, the con-
tamination of ocean water and seafood with organohalogens like PC3s or
pesticides, or the bioaccumulation of carcinogens.  Other materials strictly
limited in the regulations that might endanger human health include possible
pathogenic organisms or radioactive wastes.  The regulations are also obvi-
ously geared to protecting the marine ecosystem and economic potentialities as
well as human health:  oxygen consumptive wastes and highly acidic cr alkaline
wastes can disrupt the natural nutrient cycles, while the dumping of oil has
obvious effects on fishing and recreation.  In fact,  the bioassay casting ap-
proach favors a strict and careful assessment of the possible effects cf dump-
ing.  The regulations also give tremendous latitude to EPA to evaluate each
permit on a case-by-case basis, and to change its evaluations with updated
scientific evidence.  Flexibility, however, might have to be sacrificed to
impose consistency on the implementation of the criteria.  For example, the
Corps of Engineers analysis of dredged materials should agree with EPA's
analysis of municipal and industrial wastes because they are based on the same
criteria.  Similarly, each waste should be rated consistently for a range of
disposal options--both ocean discharges and ocean dumping.  The need for con-
sistency might eventually require a more specific designation of limitations
and allowances.
     27Council of Environmental Quality, Environmental Quality Yearbook,
1979 o. 164.

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                                      JT'I
                          RESOURCE CONSERVATION AND
                       RECOVERY ACT--STATUTORY REVIEW
INTRODUCTION

     The Resource Conservation and Recovery Act (RCRA) became law en October
31, 1976.l  Among its objectives is the protection of public health and the
environment by authorizing the regulation of the treatment, storage,
transportation, and disposal of hazardous wastes which can have adverse
effects on the environment.1  The Congress explicitly found that the
disposal of hazardous waste without careful planning and management "can
present a danger to human health and the environment."3  For example, open
dumping contaminates drinking water from underground and surface supplies and
pollutes the air and land as well."  Congress also found that hazardous
waste presents "special dangers to health and requires a greater degree of
regulation than does non-hazardous solid waste."*

     Subtitle C of the Resource Conservation and Recovery Act (RCRA) estab-
lishes the outlines of 'a comprehensive program for regulating hazardous wastes
Section 3001 directs EPA to identify the characteristics of hazardous wastes
and to list specific hazardous wastes which will be subject to regulation.
Sections 3002 and 3003 direct EPA to establish standards for generators and
transporters of hazardous wastes, including the use of a manifest system to
track shipments, require proper labels and containers, etc.  Other sections
address standards for disposal facilities, permits, and state-administered
programs.  The goal was to provide "cradle-to-grave" regulation.  Since the
journey from "cradle" (i.e., the "generator" of the waste) to "grave" (i.e.,
disposal site) often involves transportation, RCRA directed that a manifest
system be used to track shipments.

     Congress' "overriding concern" in enacting Subtitle C was to address the
risks posed to the population and the environment by the disposal of hazardous
wastes.  Congress was particularly concerned about wastes which ara "harmful,
toxic, or lethal" because of their chemical composition or "longevity."5
    lPublic Law 94-580, 42 USC §6901 et sea.

    1RCRA Section 1003(4), 42 USC §6902.

    3RCRA Section 1002(b)(2), 42 USC §6901.

    "RCSA.Section 1002(b)(4).

    5RC5A Section 1002(b)(5).

    8H.R. No. 94-1491(1), p. 3.

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DESISNATI3N AUTHORITY OF SECTION 3001

     The statute defines "hazardous wastes" broadly to include ar.y waste or
comb:jiation of wastes which "because of its quantity, concentration, or
physical, chemical, or infectious characteristics may:

     (A)  cause or significantly contribute to an increase in
          mortality or an increase in serious irreversible, or
          incapacitating reversible, illness; or

     (3)  pose a substantial present or potential hazard to human
          health or the environment when improperly treated, stored,
          transported, or disposed of, or otherwise managed.7

    Criterion (B) evidences a risk-averse, preventive goal by including mate-
rials which "may" pose a substantial "potential" hazard when "improperly"
treated.  The statutory language seems to imply that Congress did not want the
EPA to exempt any hazardous wastes from regulation on the assumption that
proper management would obviate potential hazards.

    RCRA specifies a two-step procedure which EPA must follow in designating
hazardous wastes.  First, EPA must promulgate criteria for identifying
hazardous waste characteristics; second, EPA must rdentifiy those characteris-
tics and list the hazardous wastes.  The criteria are to be the standard of
judgment for determining hazardous waste characteristics and for listing
hazardous wastes.  According to the legislative history, Congress wanted the
EPA to first develop the criteria and then identify characteristics and list
specific hazardous wastes afterwards.*  The listed wastes must satisfy the
statutory definition described above.'

    RCRA directs EPA to take into acount toxicity, persistence, and
degracability in nature; potential for accumulation in tissue; and other fac-
tors such as flammability, corrosiveness, and other hazardous characteristics
in developing the listing criteria.:8  The House Report states that
Congress wanted EPA to identify specific hazardous wastes that pose a hazard
to human health and the environment and anticipated the identification of two
basic tvaes of substances:
    'RCRA Section 1004(5), 42 USC §6903(5).  One court has stated in dicta
that "It seems clear that  [this definition] would include nuclear waste."
City of Philadelphia v. N.J. . 10 ERG 1312,1313  (N.J. Sup. Ct., 1977).

    'E.R. No. 94-1491(1), p. 25.

    'RCRA Section 3001, 42 USC  §6921.

    10RCRA Section 3001(a),  42  USC  §6921(a).

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                                   5-3
     (1)  those which are hazardous in their elemental and most
          common form, regardless of concentration  [sic]; and

     (2)  those which when present in sufficient concentration or
          when mixed with other substances constitute hazardous
          wastes.ll

    The use of designation criteria means that even if a waste is not listed
or identified as hazardous in the regulations, it is nevertheless subject to
the hazardous waste regulations so long as it meets the general criteria.
These are discussed in more detail in the regulatory review.

    The 1980 Amendments to RCRA (P.L. 96-482) added special provisions
relating to "drilling fluids, produced waters, and other wastes associated
with the exploration, development, or production of crude oil or natural gas
or geothermal energy."  The Amendments require EPA to conduce a study and
report on the "adverse effects, if any" on "human health and the environment,
including, but not limited to, the effects of such wastes on humans, water,
air, health, welfare, and natural resources and on the adequacy of means and
measures currently employed  ... to dispose of and utilize such wastes and to
prevent or substantially mitigate such adverse effects."  (Section 80G2(a))
On the basis of the study, EPA is to determine whether regulation is
warranted.  In addition, EPA is authorized by the 1980 Amendments to prescribe
regulations to prevent radiation exposure which "presents an unreasonble risk
to human health" from the use in construction or land reclamation of (1) solid
waste from the extraction, beneficiation, and processing of phosphate rock or
(2) overburden from the mining of uranium ore.  (§3001(b)(3)(A)(iii))

COORDINATION VITH OTHER ACTS

    RCRA contains specific language to assure coordination and consistency
with other EPA programs as well as other agencies, notably the Department: of
Transportation.  This is essential in view of the broad authority to regulate
hazardous wastes granted by RC&A.

    The Office of Management and Budget (OMB) took the position in its com-
ments to Congress that a substantial portion of hazardous wastes are already
subject to control through the underground injection provisions of the Safe
Drinking Water Act.12  Congress nevertheless enacted RC5A to respond to the
pollution of surface waters, croplands, and pasturelands by runoff; the pollu-
tion of air from evaporation, sublimation, wind erosion, and improper inciner-
ation; and dangers from fires and explosions in addition to the contamination
    11H.R. No. 9^-1491(1), p. 25.

    12H.R. No. 94-1491(1), p. 81.

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of gr3uncs.-s.-er by leaohate.13  Congress explicitly instructed EPA to inte-
grate the administration and enforcement of the provisions of RCRA with its
other authorities.1*  Congress also specified that RCRA should not be con-
strued to apply to any substance which is subject to the Federal water Pollu-
tion Control Act, the Safe Drinking water Act, the Marine Protection, Research
and Sanctuaries Act, or the Atomic Energy Act except to the extent that RCRA
regulations are "not inconsistent" with the requirements of those acts.15

     Similarly, in assigning EPA the responsibility to designate "hazardous
wastes" and to develop standards for transporting those wastes, Congress took
into account the Department of Transportation's long-standing regulation of
hazardous materials transport.  EPA was directed to consult with the Depart-
ment of Transportation before developing transportation standards for
hazardous wastes.1'  In addition, for any hazardous waste identified or
designated for regulation by EPA which is also subject to DOT rules under the
Hazardous Materals Transportation Act, Congress directed that EPA rules shall
be "consistent" with the DOT requirements.17  Furthermore, the legislative
history of RCRA indicates that Congress expected EPA to establish a manifest
system for tracking hazardous waste movements "in cooperation with" the
Department of Transportation.  Congress authorized EPA to make recommendations
to DOT of whether or not particular wastes were hazardous in
transportation.:I

CASELAV

     Following the issuance of EPA's rules for hazardous waste management,
fifty separate lawsuits were filed challenging the rules.15  The legal
     11 Ibid., p. 89.

     lfcClean Air Act; Federal Water Pollution Control Act; Federal
Insecticide, Fungicide, and Rodenticide Act; Safe Drinking Water Act; Marine
Protection, Research and Sanctuaries Act.  RCRA Section 1006(b),
42 USC §69C5(b).

     1SRCRA-Section 1006(a), 42 USC §6905(a).

     16Section 3003(a).

     17Section 3003(b).

     :'HR No. 94-1491(1),'p. 6 (see also p. 27:  EPA "is required to
coordinate these regulations with those of the Secretary of Transportation
regarding transportation of hazardous materials.").

     19The suits were  filed by one environmental group seeking to sharpen
the requirements and thirty-seven companies and trade associations seeking to
overturn them.  3 The  National Law Journal pp. 1, 24-5 (November 10, 1980).

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                                   5-5
challenges were consolidated in the U.S. Court of Appeals for the District of
Columbia Circuit early in October, 1980 and, with many of the industrial
plaintiffs seeking stays of the rules while suits are pending, it may be a
year or two before the cases are decided.  As of January 1, 1981, none of the
issues had been judicially resolved.

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                          RESOURCE CONSERVATION AND
                       RECOVERY ACT--REC-ULATGRY REVIEW
     This section summarizes "he identification and listing of hazardous
wastes promulgated under the authority-of Section 3001 of the Resource
Conservation and Recovery Act.  It is organized in the following manner:

          •    Summary of Regulations--provides a brief
               background on the regulatory history and
               approach to hazardous waste designation.

          •    Criteria for Designation--presents EPA's
               approach to and criteria for designating of
               chemicals as hazardous wastes.

          •    List of Cheaicals Designated--includes the
               list of chemicals designated as of January 1,
               1981, as hazardous wastes, and discusses issues
               relating to the identification of the chemicals.

SUMMARY 0? REGULATIONS

    Hazardous wastes are regulated by EPA under Subtitle C of the Resource
Conservation and Recovery Act (RCRA) of 1976.l  Subtitle C mandates EPA to
establish a "cradle-to-grave" management system for hazardous wastes.  The
centerpiece of this system is Section 3001, "which requires EPA to identify  and
list those solid wastes which must be managed as hazardous wastes according  to
the standards established by EPA under Sections 3002 through 3005.":

    Section 3001 entails a two-step process.  Under Section 3001(a), EPA must
develop criteria for identifying the characteristics of hazardous waste and
for listing hazardous wastes.  Under Section 3001(b), EPA must then actually
identify specific characteristics of hazardous waste and list particular
hazardous wastes.  Wastes which are listed as hazardous are subject to
Subtitle C regulations of recordkeeping, management, etc.
    :42 USC §6901 et seq.  See Statutory Review, above.

    2 Introduction to Final Rule and Interim Final Rule on Hazardous Waste
Management Systems:  Identification and Listing of Hazardous Waste.
45 FR 33084 '(May 19, 1980), p. 33085.

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                                   5-7
    EPA developed its Subtitle C regulations over the course of 1977 and 1973.
Exhibit 5-1 summarizes the regulatory history of hazardous wastes regulations
through January 1, 1981.  EPA's final rules differ from the proposed rules in
their organization, and the final rules clarify many provisions of the
proposals.  Some substantive changes were made to the regulations, based on
the extensive comments received on the proposed rules; relevant changes are
noted, where applicable, in the next section.

    The final regulations define solid waste as-"any garbage, refuse, sludge
or any other waste material",5 and they define hazardous waste as any solid
waste that appears on the list of hazardous wastes and/or that exhibits any of
the defined characteristics of hazardous waste.*

CRITERIA FOR DESIGNATION

    EPA used two mechanisms for classifying wastes as hazardous:  (1)
identifying characteristics which make the wasre hazardous, and (2) iden-
tifying criteria for listing certain wastes directly.  Although the two
mechanisms overlap, we discuss each separately.

    Identification of Characteristics

    EPA developed two criteria in order to identify characteristics that would
cause solid wastes to be defined as hazardous wastes.  The criteria ara:

     1.   If the characteristic exhibited by the solid waste may

          (i)  "cause, or significantly contribute to, an increase
               in mortality or an increase in serious irreversible,
               or incapacitating reversible, illness; or

          (ii) pose a substantial present or potential hazard to
               human health or the environment when it is improperly
               treated, stored, transported, disposed of or
               otherwise managed; and

     2.   The characteristic can be:

          (i)  measured by an available standardized test method
               which is reasonably within the capability of
               generators of solid waste or private sector
               laboratories that are available to serve generators
               of solid waste; or
     340 CJH 261.2(a).

     "40 C7R 261.3(a).

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                                   5-S



                                 EXHIBIT 5-1

                            REGULATORY CHRONOLOGY
Dare

1976

1977-1973


Fall 197S



December 13, 1978

1979

January 3, 1979


August 22, 1979


December 18, 1979


May 19, 1980



July 16, 1980



October 30, 1980
November 12, 1980
January 16, 1981
RCRA enacted.

EPA holds meetings with agencies and organisations to
obtain suggestions.

EPA sued under RCRA Section 7004 to force promulgation
of final 3001 regulations by a date certain.   [State of
Illinois v. Costle,  12 ERG 1597 (D.D.C. 1979)]".

EPA proposes hazardous waste regulations  (43 FR 58949).

Public hearings.

Court orders EPA to issue final 3001 regulations by
December 31, 1979.

EPA proposes supplemental list of hazardous wastes
(44 FR 49402).

Court order modified to have EPA try to meet April 1930
promulgation date.

EPA promulgates final and interim final rules  for
hazardous waste lists; proposes listing of  11
additional wastes (45 FR 33084).

EPA promulgates interim final rules for an  additional
18 wastes, defers action on six wastes, proposes
listing for seven other wastes  (45 FR 47835).

EPA delists eight waste streams (final action), amends
the E? toxicity characteristic as it applies to
chromium  (proposed rule), and temporarily excludes
certain wastes from hazardous waste status  (interim
final rule)  (45 FR 72024).

EPA finalizes the listing of 80 hazardous wastes;
defers action on five others (45 FR 74884).

EPA finalizes list of 13 additional hazardous  wastes,
deleted several other wastes, and deferred  action on
others  (46 FR 4614).

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                                   5-9
          (ii) reasonably detected by generators of solid waste
               through their knowledge of their waste."*

     The first criterion thus requires that the characteristics cause the
waste to be hazardous within the meaning of the statutory definition cf
hazardous waste.  The second criterion recognizes that the characteristics
must be easily measurable by the generators who have primary responsibility
for determining whether their wastes exhibit the hazardous characteristics.
Both criteria must be met for the characteristic to be defined as hazardous.

     EPA identified the following four characteristics of hazardous waste
which meet the two criteria discussed on the previous page:5

     (1)  ignitability-pbsing a fire hazard during routine
          management;

     (2)  corrosivity-ability to corrode standard containers, or to
          dissolve toxic components of other wastes;

     (3)  reactivity-tendency to explode under normal management
          conditions, to react violently when mixed with watar, or
          to generate toxic gases; and

     (4)  extraction procedure (EP) tcxicity (as determined by a
          specific extraction procedure)--presence of any of 14
          specified toxic materials within the waste at levels
          greater than the maximum concentration specified in the
          regulation.  The characteristic of EP toxicity is intended
          as a model of a. prevalent fora of waste mismanagement--the
          co-disposal of toxic wastes in an actively decomposing
          municipal landfill which overlies a groundwater aquifer.
          The EP test, which is innovative in character, is designed
          to simulate the physical processes which would occur in an
          actual landfill.7
     S40 CFR 261.10.

     4 40 CTR 261.21-261.24.

     rPreamfale to the Final Rules, pp. 33110-1.  The extraction procedures
and test methods are specified in Appendix II to the Final Rules.  The 14
chemicals and their concentrations were specified in the National Intaria
Primary Drinking Water Standards.  EPA was unable to extend the extraction
procedure to additional contaminants because no other chronic exposure
threshold levels relating to drinking water consumption have been established
for other contaminants.

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                                   5-10
     Each cf the four characteristics- is described in the regulations  in  terras
cf specific measurable properties.  Any waste exhibiting one or more of these
characteristics is defined by 40 CFR 261.20(a) as a hazardous waste.   In  a  few
cases, wastes with a hazard characteristic are explicitly listed in 4D CFR
251.21 and 261.32.  The large majority of wastes with these characteristics,
however, are defined as hazardous by rule.

     Exhibit 5-2 shows the maximum concentration of 14 contaminants above
which a waste has the characteristic of E? toxicity:
                                 EXHIBIT 5-2

                                 £? TOXICITY


                   Contaminant            Maximum Concentration
                                          (milligrams per liter)

               Arsenic                              5.0

               Barium                             100.0

               Cadmium                              1.0


               Chromium  (VI)-7                      5.0

               Lead                                 5.0

               Mercury                              0.2

               Selenium                             1.0

               Silver                               5.0

               Endrin                               0.02

               Lindane                              0.4

               Methoxychlor                         10.0

               Toxaphene                            0.5

               2,4-D                                10.0

               2,4,5-T?  Silvex                      1.0
     -''proposed amendment,  45 FR  72029,-October  30,  1980.

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                                   5-11
     EPA had originally intended to also include as characteristics of hazard-
ous waste:  organic toxicity, carcinogenicity, mutagenicity, teratogenicity,
bioaccumulation potential, and phytotoxicity.  Because EPA later considered
the available test protocols for measuring these characteristics to be either
insufficiently developed or too complex, in its final rules the Agency decided
to directly list toxic constituents known to have the properties of carcino-
genicity, mutagenicity, etc.

     Criteria for Listing Hazardous Wastes

     EPA developed three main criteria for listing hazardous wastes.  The first
criterion is that the waste exhibits any of the four characteristics of haz-
ardous waste outlined above.  Secondly, wastes that are acutely hazardous are
listed.  These are wastes that EPA considers to be so acutely hazardous that,
unlike most wastes, "they can be considered to present a substantial hazard
whether improperly managed or not.'  The third criterion involves wastes
that contain designated toxic constituents which "have been shown in reputable
scientific studies to have toxic, carcinogenic, mutagenic or teratogenic
effects on humans or other life forms and include such substances as those
identified by the Agency's Carcinogen Assessment Group."3

     Using these criteria for directly listing hazardous waste, EPA compiled a
list of chemicals considered to be either acutely hazardous or toxic, which
are or will be subject to regulation.  This list, referred to as Appendix VIII,
contains over 350 hazardous constituents;15 the presence of any of these
     'Preamble to the Final Rules, p. 33106.  [Emphasis added.]  Specific-
ally, the regulation states that such a waste "has been found to be fatal to
humans in low doses or, in the absence of data on human toxicity, it has been
shown in studies to have an oral LDSO toxicity (rat) of less than 50 milligrams
per kilogram, an inhalation LCSO toxicity (rat) or less than two milligrams
per liter, or a deraial LDSO toxicity (rabbit) of less than 200 milligrams per
kilogram or is otherwise capable of causing or significantly contributing to
an increase in serious irreversible, or incapacitating reversible, illness.
(Waste listed in accordance with these criteria will be designated Acute
Hazardous Waste.)" (40 CFS 261.11(a)2).  These wastes are "so potentially
lethal as to be considered poisonous or acutely toxic", and include wastes
such as explosives which meet the statutory definition of hazardous waste.

     "Preamble to the Final Rules, p. 23107.

     13Note that in using the criteria for listing, EPA actually identifies
specific chemicals to be regulated.  This is in contrast to EPA's identifica-
tion of hazard characteristics which cause wastes to be listed as hazardous by
general rule.  Appendix VIII, with the list of chemicals to be regulated, is
used by the Agency in three ways in the final rules:  (1) as the basis for
listing specific waste streams in 261.31 and 261.32; (2) as the basis for list-
ing acutely hazardous wastes in 261.33(e); and (3) as the basis for listing
toxic wastes in 261.33(f).  Appendix VIII itself is not a regulation.

-------
ation of certain designated factors, Z?A concludes the waste is net hazardous,
The factors designated are:

        (i)  The nature of the toxicity presented by the constituent.

       (ii)  The concentration of the constituent in the waste.

      (lii)  The potential of the constituent or any toxic degrada-
             tion product of the constituent to migrate from the
             waste into the environment under the types of improper
             management considered in (vii) below.

       (iv)  The persistence of the constituent or any toxic degra-
             dation product of the constituent.

        (v)  The potential for the constituent or any toxic degra-
             dation product of the constituent to degrade into
             non-harmful constituents and the rate of degradation.

       (vi)  The degree to which the constituent or any degradation
             product of the constituent bioaccumulates in ecosystems.

      (vii)  The plausible types of improper management to which the
             waste could be subjected.

     (viii)  The quantities of the waste generated at individual
             generation sites or on a regional or national basis.

       (ix)  The nature and severity of the human health and envi-
             ronmental damage that has occurred as a result of the
             improper management of wastes containing the
             constituent.

        (x)  Actions taken by the other governmental agencies or
             regulatory programs based on the health or environmen-
             tal hazard posed by the waste or waste constituent.

       (xi)  Such other factors as may be appropriate.11

     The lists of hazardous waste and related substances are discussed in
detail in the next section of this paper.  Before moving on to the lists, we
briefly discuss a few important points about the criteria outlined here.  To
follow the discussion more clearly, please refer to Exhibit 5-3 on the next
page, which distinguishes among the various components of the system.
          C7R

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                                   5-13



                                 EXHIBIT 5-3

                        WASTES DESIGNATED UNDER RCRA
Mechanism for
 Regulation

Identification of
Characteristics
(RCHA Section 300Ib)
Criteria for Listing:
(RCXA Section 3001a)
    What Wastes
    Are Involved

4 characteristics iden-
tified:  ignitability,
corrosivity, reactivity,
ZP toxicity (14 consti-
tuents) (40 C7R 261
Subpart C)
(40 CFR 261.11)
  How They Appear in
   The Final Rules

Some wastes with these
properties ara explicitly
listed in 261.31 and
261.32.  Any other waste
that has any of these
characteristics is
defined as hazardous.
(1) Wastes with the
    4 characteristics
    above
See above
See above
(2) "Acute Hazard"
ratal to humans in low
doses or otherwise ex-
tremely toxic however
they are managed.  Usually
only pure chemicals will
meet this definition, not
constituents in a waste.
Examples of "acutely
hazardous waste" are
dieldrin, phosgene, and
cyanides.
Provisions apply only
to pure chemicals and
associated containers,
etc.  A list of these
chemicals is contained
in 261.33(e), and they
are subject to regulation
in very small quantities.
(Note that most of these
chemicals are drawn from
Appendix VIII.)
(3) "Toxicity"
Carcinogenic, mutagenic,
teratogenic, phytotoxic,
organically toxic, or
having potential for bio-
accumulation.  Examples
of "toxic waste" are
toluene, benzene,
saccharin, formaldehyde.
Chemicals with these
properties appear in
Appendix VIII.   They are
regulated in two ways:
(1) in Sections 26l".31
    and 251.32, which
    list specific hazard-
    ous waste streams and
    processes;  and
(2) in 261.33(f), which
    lists gura chemicals
    that are hazardous
    wastes if discarded.

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                                   5-14
     As discussed above, the criteria for listing hazardous wastes reflect
a cnar.ge in EPA's enphasis from the strategy plannec at the time of the pro-
posed rules.  Because EPA decided that the characteristics of hazardous waste
would have to be readily measurable, the Agency needed an independent basis
for capturing hazardous waste that could not be suitacly tested by generators.
EPA, therefore, revised its use of the listing mechanism from a supplementary
function that would provide certainty about which wastes were hazardous, to a
major function in the process of hazardous waste determination.

     In its final rules, EPA relies on the listing mechanism to capture toxic
wastes containing constituents believed to be carcinogenic, mutagenic,  etc.,
as well as the acutely hazardous wastes.  This approach entails a shift in the
burden of identifying and evaluating these wastes onto EPA rather than  the
generators.  EPA believes that the use of direct listing, coupled with  provi-
sions for rebuttal of the listing based on several factors, and accompanied by
a delisting procedure, ensures a flexible and suitable approach.

     The two approaches of identification of characteristics and criteria for
listing differ in the degree of discretion retained by the Agency.  This
affects the emphasis EPA gives to waste constituent migration and environmental
fate in the two approaches.  As noted, the use of direct listing (for example,
for substances which are carcinogenic! actually involves a more flexible
approach, because each such waste is evaluated individually and mitigating
factors can be considered in determining hazard.  Because of this, EPA  concen-
trated in its list on the composition of the waste, feeling that other  miti-
gating factors such as migration potential which might render the waste
hazardous, could be considered individually and by means of the delisting pro-
cedure.  In the characteristics, on the other hand, there is no room  for such
flexibility because the tests for characteristics constitute a final  determi-
nation of hazard.  EPA, therefore, attempted to incorporate migration potential
directly into the tests for the E? toxicity characteristic."

     In the course of regulatory development, EPA considered and then rejected
two different approaches to determining the scope of regulatory coverage.  The
first was to base a determination that a waste is hazardous on the quantity of
waste under consideration.  However, the Agency found that no assessments
could be made for most wastes that would take into account the possible
exposures of the waste as well as the intrinsic hazard of the waste.  That is,
the Agency could not define de minimis quantities below which a waste would
not be hazardous under Section 1005(5) of RCRA, without knowing the particular
management system for the waste and the consequent exposure and risk  patterns.

     Secondly, EPA considered using the degree of hazard presented by a par-
ticular waste to establish different levels or types of controls.  The  objec-
tives of such a system would be to  implement the Subtitle C program more
      12?reamble to the Final Rules, p. 33107.

-------
                                   5-15
efficiently by establishing regulatory priorities, and to reduce the economic
burden imposed on generators of relatively low hazard wastes.  As suggested by
a large number of commenters,  the degree of hazard classification would ulti-
mately relate to the health or environmental effects of the waste, and could be
based on the chemical and physical properties of the waste and/or on the way
the waste is managed.  EPA found the degree of hazard system "conceptually
appealing," but believes that neither the information nor the techniques exist
to adequately distinguish the many hazardous wastes into appropriate catego-
ries .   EPA maintains that in a variety of ways, its regulations do achieve the
objectives of a degree of hazard system.  One example cited is the very lew
exclusion limits established for acutely hazardous chemicals.::

LISTS OF HAZARDOUS WASTES

     This section discusses:

          •    naming and identification conventions used for
               listed wastes;

          •    test methods;

          •    concentration and quantity limits; and

          •    exclusions, deferred actions, delisting.

     Because of the complexity and overlap in the lists and appendices promul-
gated by EPA, we have summarized some of the relevant information in Exhibit
5-4.  There are basically two types of wastes being regulated here:  (1)
specific waste streams and processes which contain hazardous constituents or
which have any of the four characteristics of hazard (261.31, 261.32); and (2)
discarded pure chemical products and associated materials which might be
discarded because the product did not meet the required specifications, or
because inventories were being reduced, or because the product line had
changed.  Two lists are given here:  261.33(f) has toxic chemicals which are
regulated at the same exclusion level (under 1000 kg/mo) as other hazardous
wastes.  261.33(e) has acutely hazardous chemicals, regulated at very small
quantities.  Note that these chemicals are not listed as constituents of
hazardous waste, but as wastes themselves.

     An example of how these lists of chemicals and waste interrelate should
help to clarify the system.

     Example:  Acrylonitrile.

     Acrylonitrile is a hazardous constituent appearing in Appendix VIII.  The
actual chemical product acrylonitrile if discarded or intended to be discarded,
      13Preamble to 40 CTS. Parts 264 and 265, pp. 33164-66.

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                                   5-17
is regulated as a "toxic" (hazardous) waste (listed under 261.33(f) with the
Hazardous Waste Number U009).  Particular wastes containing acrylcnitriie are
also specifically listed in Section 261.32, for example:

Hazardous Waste No.                     Hazardous Waste

      K011                   Bottom stream from the waste water stripper in
                             the production of acrylonitrile

      K013                   Bottom stream from the acetonitrile column in the
                             production of acrylonitrile.

    To find out what hazardous constituents are associated with these waste
streams, we turn to Appendix VII, which shows:

Hazardous Waste No.                 Basis for Listing

      K011                   acrylonitrile, acetonitrile, hydrocyanic acid

      K013                   hydrocyanic acj.d, acrylonitrile, acetonitrile

     Thus, there are two ways in which acrylonitrile falls under Subtitle C
regulations:  as a discarded pure chemical, and a constituent of specific
waste streams.

     Naming:  EPA has used CAS-preferred14 and/or generic names for most of
its lists of chemicals; in addition, some trade names of which the Agency is
aware are provided.  Each listed hazardous waste is assigned a Hazardous Waste
Number (see Exhibit 4), which must be used by industry in complying with the
notification requirements of Section 3010 of the Act and certain recordkeeping
and reporting requirements (under Parts 262 through 265 and
Part 122).

     Test Methods:  Because of the need to have generators test their own
wastes to determine if they are hazardous, EPA's final rules are very explicit
about test methods that can be used.  For each of the four characteristics of
hazardous waste, EPA provided specific standards that define the characteris-
tic, and test methods, where applicable.  (See Appendix to this paper.)  EPA
also outlined sampling techniques and appropriate analytic procedures for the
organic and inorganic chemicals in Appendix VII that should be used in deter-
mining whether the waste in question contains a given toxic constituent.15
     lfcCAS-preferred names are those used by the Chemical Abstract Service
of the American Chemical Society.
     is
       Appendix III to the Final Rules.

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                                   5-18
     Concentration and Quantities:  EPA added Section 261.3 (Definition of
Hazardous Waste) to its final rules to clarify questions about the proposed
rules, including the issue of waste mixtures.   EPA notes in its preamble that
this is a very real issue "in real-world waste management, since many hazard-
ous wastes are mixed with non-hazardous wastes or other hazardous wastes dur-
ing storage, treatment, or disposal."1'  The rules state that a "mixture of
solid waste and one or more listed hazardous wastes" or a waste mixture that
exhibits any of the characteristics of hazardous waste is considered to be a
hazardous waste.17  EPA recognized that this approach might be unsatisfac-
tory in some cases, because some waste mixtures commingle wastes in a way that
neutralizes them, or contain only very small amounts of listed wastes, although
on the other hand, some hazardous wastes will escape detection and regulation
merely by being mixed with other wastes.   The Agency provided for exemptions
for individual facilities if they can show that their waste mixtures are not
hazardous, but citing its own lack of resources, EPA noted that this rulenaking
procedure would only be practical for facilities that routinely mix wastes in
relatively constant proportions.

     In a similar vein, EPA set an initial general exclusion limit for gen-
erators of less than 1000 kilograms per month (kg/mo) of hazardous waste (with
lower limits for acutely hazardous wastes).  The Agency considered three
exclusion levels:  100 kg/mo, 1000 kg/mo, and 5000 kg/mo.18  The level
chosen (1000 kg/mo) would exclude 91.2 percent of the estimated 760,000 gen-
erators from regulation.  However, EPA determined that its administrative
resources would not be sufficient to effectively regulate hazardous waste
below that level.  EPA plans to initiate rulemaking within two to five years
to expand Subtitle C coverage down to generators of 100 kg/mo.

     At present, however, the coverage policy means that a generator of over
1000 kg/mo of wastes that contain a small quantity of listed hazardous con-
stituents must comply with Subtitle C regulations, while a generator discard-
ing up to 1000 kg/mo of pure toxic chemicals such as benzene, dimethylnitrosa-
mine, or mercury is not subject to Subtitle C requirements.

     Delisting:  EPA revised and simplified its proposed procedures for-
"delisting" a waste declared hazardous.  These are contained in Sections 260.20
and 260.22 of the final rules.  A person petitioning the Administrator to
exclude a waste at a particular generating facility from the lists in 40 CFR
261 must demonstrate that the waste does not meet any of the criteria under
which it was listed as hazardous.

     Exclusions:  A variety of wastes have been excluded from EPA's final  .
rules of May 19, 1980.  These are summarized in Exhibit 5-5, along with the
reason for excluding them.
     1'Preamble to the Final Rules, p. 33095.

     1740 CFR 261.300(2) and  (3).

     l*Preamble to the Final Rules, pp.  33104-5.

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                                   5-19



                                 EXHIBIT 5-5

                                 EXCLUSIONS
Section             Exclusions

261.4(a)     Materials which are not solid
             wastes:

             •  Domestic sewage
             •  Domestic sewage mixing
                with sanitary wastes
                passing through a sewer
                system to a POTW for
                treatment
             •  Industrial point source
                discharges regulated under
                the Clean Water Act, as
                amended, Section 402
             •  Irrigation return flews
             •  Source, special nuclear or
                by-product material defined
                by the Atomic Energy Act
             •  In-site mining wastes

261.4(b)     Solid wastes which are not
             hazardous wastes:

             •  Household wastes
             •  Agricultural or animal
                wastes

             •  Mining wastes
             •  Fly ash waste, bottom ash
                waste, slag waste and flue
                gas emission control waste
                generated primarily from the
                combustion of coal or other
                fossil fuels
             •  Drilling fluids, produced
                water, and other wastes
                associated with the explora-
                tion, development or pro-
                duction of crude oil,
                natural gas, or geothennal
                energy.
     Basis for Exclusion
  Section 1004(27)  of RCRA.
  Avoid duplication with CVA
  (Section* 1004(27) of RCRA).
  Definition of solid waste i:
  Section 1004(27) of RCRA
  Legislative history of RCRA
1980 RCRA Amendments
(Section 3001(b)(2),(3))

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                                   5-20
                                 EXHIBIT 5-5

                                 EXCLUSIONS
                                 (continued)
Section             Exclusions                     Basis for Exclusion

261.5        Less than 1000 kilograms of        Lack of administrative resour-
             hazardous wastes in a calendar     ces to regulate effectively
             month

             Less than specified amounts of
             acutely hazardous chemical
             products (1 kilogram for chemi-
             cals in 261.33(e); containers
             larger than 20 liters capacity;
             10 kilograms of inner liners of
             containers; 100 kilograms for
             residue or contaminated soil,
             water or other debris from
             cleanup of a spill of chemicals
             listed in 261.23(e).)

261.5        Wastes which contain trivalent     Temporary exclusion to main-
             chromium exclusively, such         tain consistency of rales
             as tannery wastes.                 until E? toxicity characteris-
                                                tics can be amended to distin-
                                                guish between trivalent and
                                                hexavalent chromium.

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                                   5-21



                                  APPENDIX A

               MEASUREMENT OF CHARACTERISTICS AND TEST METHODS
     This appendix presents the definitions and measurement techniques of the
four characteristics of hazardous waste.  Where test methods are specified,
EPA also permits equivalent test methods to be used if they are approved by
EPA under the procedures set forth in 40 CFR 260.20 and 260.21.  Volume I of
this report includes a comparative analysis of test methods for identifying
hazards.

     A.   IGNITABILITY (40 CFR 261.21).  A solid waste exhibits the
characteristic of ignitability if a representative sample of the waste has any
of the following properties:

     (1)  It is a liquid, other than an aqueous solution containing
          less than 24 percent alcohol by volume, and has a flash

          point lass than 60°C (140°F), as determined by a
          Pensky-Martens Closed Cup Tester, using the test method
          specified in ASTM Standard D-93-79, or a Setaflash Closed
          Cup Tester, using the test method specified in ASTM
          standard D-3278-78.

     (2)  It is not a liquid and is capable, under standard temper-
          ature and pressure, of causing fire through friction,
          absorption of moisture or spontaneous chemical changes
          and, when ignited, bums so vigorously and persistently
          that it creates a hazard.

     (3)  It is an ignitable compressed gas as defined in 49 CFR
          173.300 and as determined by the test methods described  in
          that regulation.

     (4)  It is an oxidizer as defined in 49 CFR 173.151.

     B.   CORROSIVITY (40 CFR 261.22)  A solid waste exhibits the
characteristic of corrosivity if a representative sample of the waste has
either of the following properties:

     (1)  It is aqueous and has a pH less than or equal to two or
          greater than or equal to 12.5, as determined by a pH meter
          using the test method specified in the "Test Methods for
          the Evaluation of Solid Waste, Physical/Chemical Methods"
          (also described in "Methods for Analysis of Water and
          Wastes" EPA 600/4-79-020, March 1979).

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     (I)  It is & liquid and corrodes steel (SAZ 1C20) at a rate
          greater than 6.25 mm (0.250 inch) per year at a test

          temperature of 55 C (130W?) as determined by the test
          method specified in NACE (National Association of Cor-
          rosion Engineers) Standard TM-01-69 as standardized in
          "Test Methods for the Evaluation of Solid Waste,
          Physical/Chemical Methods".

     C.   REACTIVITY (40 CFR 261.23)  A solid waste exhibits the
characteristic of reactivity if a representative sample of the waste
has any of the following properties:

     (1)  It is normally unstable and 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 in a quantity sufficient to present a danger to
          human health or the environment.

     (5)  It is a cyanide or sulfide bearing waste which, when
          exposed to pK conditions between two and 12.5, can
          generate toxic gases, vapors or fumes in a quantity
          sufficient to present a danger to human health or the
          environment.

     (6)  It is capable of detonation or explosive reaction if it is
          subjected to a strong initiating source or if heated under
          confinement.

     (7)  It is readily capable of detonation or explosive decom-
          position or reaction at standard temperature and pressure.

     (S)  It is a forbidden explosive as defined in 49 CFR 173.51,
          or a Class A explosive as defined in 49 CFR 173.53 or a
          Class B explosive as defined in 49 CFR 173.88.

     D.   E? TOXICITY (40 CFR 261.24, Appendix II)  A solid waste exhibits
the characteristic of EP toxicity if, using the test methods described  in
Appendix II of RCRA regulations or equivalent methods approved by the
Administrator under the procedures set forth in §§260.20 and 260.21, the
extract from a representative sample of the waste contains any of the
contaminants listed in [Exhibit 2 above] at a. concentration equal to or
greater than the respective value given in that [Exhibit].  Where the waste
contains less than 0.5 percent filterable solids, the waste itself, after
           is considered to be the extract.

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                                   5-23
     Appendix II [of the regulations] provides (a) the extraction procedure to
be followed for extracting solid components of the wasre sample; (b) a
separation procedure for separating the free liquid portion c£ the wasre from
any solid matter having a particle size greater than 0.45 micrometers; and (c)
analytical procedures for analyzing the extract contaminants.

     EPA also recommended protocols for obtaining representative samples
(Appendix I) of the regulations when testing a waste sample for any of the
four characteristics.

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                     FEDERAL INSECTICIDE'. FUNGICIDE AND
                 RODENTICIDE ACT (FIFRA") — STATUTORY REVIEW
INTRODUCTION
     This statutory review is divided into three main parts.  The  first of
these is entitled "Background" and gives a brief history of the evolution of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFHA).   The second
part deals with the statutory provisions of FIFRA, particularly the aajcr ac-
tions available to EPA and the bases for these actions.  The final part inves-
tigates some of the standards which the courts have established for cases
arising under FIFHA.  Particular attention is paid there to why the courts
often avoid reaching substantive issues in these cases and to the  standard's
which have evolved for review of suspension and cancellation orders.


BACKGROUND

     The purpose of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA)1J  is to rsgulata the use of pesticides in order to prevent "unrea-
sonable adverse effects" on the environment.  The environment includes "water,
air, land and all plants and man and other animals living therein, and the
interrelationships which exist anong these."2J

     The pesticide program was originally located in the Department of Agri-
culture.  Since 1970, FIFRA has been administered by the Environmental Protec-
tion Agency (EPA).  The Act assigns responsibility to EPA in three major
areas.3-1  First, the Agency administers a registration program under which
no "pesticide" can be shipped, delivered, or sold within the United States
without first being registered with EPA.  This process is intended to enable
EPA to judge a product's safety before allowing it to be marketed.  EPA is
required by statute to publish the guidelines which govern the registration
process.  Second, EPA administers a program under which registered pesticides
are classified as being available for either general use or restricted use.
This classification results in restrictions on the methods by which or amounts
in which certain pesticides can be applied or used.  Third, EPA can cancel or
suspend the use of any previously registered pesticide which the Agency has
determined to be unreasonably unsafe.
     17 USC §§136 et seq.

     2Section 2(j).  Unless otherwise specified, statutory references will
be to FIF5A.

     JE?A is also charged with other duties such as monitoring the disposal
of unused pesticides and providing the Secretary of Transportaion with assis-
tance in fulfilling his responsibilities for the transportation of hazardous
materials.

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                                   6-2

     The first legislation concerned with the use of chemical pesticides was
the Federal Insecticide Act of 1910.  This legislation was replaced by FIFRA
in 19<-7, wnich authorized the registration of pesticides used in intrastate
and interstate commerce.  The authority to deny or suspend registration, which
effectively prohibits the use of some pesticides, was not granted until 196i.
The emphasis, however, was still on protection of consumers from ineffective
produces.

     A significant change occured when FIFRA was substantially amended by the
Federal Environmental Pesticide Control Act of 1972.  These amendments reflec-
ted the growing concern about the potential adverse effects of pesticides and
changed FIFRA from a labeling law zo a. regulatory statute.  The Administrator
of EPA is  now required to register all pesticides before they can be shipped,
delivered or sold within the United States, including intrastate as well as
interstate commerce.1'-  The process of registration requires r-he review of
premarket  data for new products against the risks to the environment posed by
their use.   In addition, EPA reexamines previously registered products, re-
registering only those which meet current safety standards.  The registration
of those products which have "unreasonable adverse effects" on the environment
is denied or cancelled.

     In 1975, amendments to FIFRA specified that the Agency must submit its
proposed cancellation of registration actions to a Scientific Advisory Panel
and to the Secretary of Agriculture before initiating cancellation proceed-
ings. 5j  The Agency must specifically analyse the impact of its decision on
the production of agricultural commodities, retail food prices, and other
aspects of the agricultural economy.8-'  This essentially reinforces the
Agency's mandate to weigh the benefits of pesticide use against the risks to
the environment.

     FIFRA was again amended in 1373.  Many of che 1973 amendments to FIFRA
reflect the difficulties EPA encountered in reregistering thousands of pesti-
cide products.  The amendments:

          •    authorize a simplified approach to
               registrarion (Section 3(c)(2)(C)) which is the
               basis for the Agency's proposed generic
               Registration Standards Program under which it
               will adopt a chemical-by-chemical approach to
               registration rather than a product-by-product
               approach as was previously required  (44 Federal
               Register 76311, December 26, 1979);
     ""The states themselves may also legislate to control pesticides;  such
legislation must provide safeguards at least as demanding as those of  FIFRA.

     5Sections 6(b)and 25(d).

     'Organized Migrants in Community Action v. Brennan, 520 F.2d  1161
(D.C. Cir. 1975) held that, pursuant to FIFRA, EPA, not the Secretary  of  Labor
under the Occupational Safety and Health Act, has authority to provide
protection for farmworkers from hazards arising from pesticide exposure.

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                                   6-3

          •    authorize conditional registration of
               pesticides (such as those whose formulations are
               similar to already registered pesticides) to
               allow greater flexibility in fulfilling data
               requirements (Section 3(c)(7));

          •    authorize waiver of the finding of efficacy as
               a requirement for registration in order to
               concentrate the Agency's resources on assessment
               of health and safety questions (Section 3(c)(5));

          •    direct EPA to consider restriction of
               pesticide use as an alternative to total
               cancellation;

          •    direct EPA to prepare an agricultural impact
               statement for any regulations issued; and

          •    authorize EPA to classify registered
               pesticides for restricted use by regulation
               prior to full re-registration.

     In addition, Section 3(c)(8) explicitly states that the Administrator may
not undertake a risk-benefit analysis of a pesticide prior to initiating for-
mal proceedings to cancel, suspend, or deny registration unless the action is
based on a validated test or other significant evidence concerning unreasona-
ble risk to man or the environment.
STATUTORY PROVISIONS

     The key provisions of FI7RA for purposes of this statutory review include
the following:

          •    Section 2 Definitions of Substances Subject to
               Regulation

          •    Statutory Criteria for Registration (Sections
               3(a)-(c), Classification (§3(d)), Cancellation of
               Registration (§§6(a)-(b)), and Suspension ((§6(c))

          •    Other Regulatory Authority (§§19, 25)

These provisions will be reviewed next.


Chemical Substances Subject to Regulation

     7ITRA allows regulation of any chemical which qualifies as a
"pesticide."  Pesticide is defined as "(1) any substance or mixture of
substances intended for preventing, destroying, repelling, or mitigating any
pest, and (2) any substance or mixture of substances  intended for use as a

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                                 6-4
                               fWTn -"
                     OVrPV"'TW HT CTiTT'vpv "DTTpJ
                     WV—ivV—.u>IT w - wiili.^itaJi\» W-\.*._— TvX
            ACTION
Deny registration or re-registration
for sane or all uses of a oesticide
Cancellation of registration
Conditional registration
               CRITERIA

(1)   The pesticide's composition
     does not warrant the proposed
     claim for it;
(2)   Its labeling does not comply
     with ?IFRA requirements;
(3)   It will not perform its inten-
     ded function without
     unreasonable adverse effects
     on the environment;  Section
     3(c)(5)(C) or
(4)   When used in accordance with
     widespread and comnonly recog-
     nized practice, it will gene-
     rally cause unreasonable ad-
     verse effects  on the environ-
     ment.  (Section 3(c)(6)j

(1)   If pesticide or its labeling
     does not comply with FIFRA pro-
     visions
(2)   When used in accordance with
     widespread and commonly recog-
     nised practice, it will gene-
     rally cause unreasonable
     adverse effects on the
     environment.
     EPA must consider restricting a
     pesticide's use(s) as an alter-
     native to cancellation; and
     shall take into account the
     impact of cancellation on pro-
     duction and prices of agricul-
     tural commodities, retail food
     prices, and the agricultural
     economy.  (Section 6(b))

     Action would not significantly
     increase the risk of any
     unreasonable adverse effect on
     the environment.  (Section
     3(c)(7))

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                                 6-5
                               EXHIBIT 6-1

                     OVERVIEW OF STATUTORY CRITERIA
                               (Continued)
            ACTION

Restricted use classification
Change in use classification
Suspension of registration
          CRITERIA

The pesticide, when applied in
accordance win its directions
for use or in accordance with a
widespread and commonly recog-
nized practice, may generally
cause, without additional
regulatory restrictions,
unreasonable adverse effects
on the environment, including
injury to the applicator.
(Section 3(d)(l)'(C))
Change to restricted use
classification is r.acassar-
                                                                          ~o
prevent unreasonable adverse
effects on the environment.
(Section 3(d)(2))

Change to general use would
not cause unreasonable adverse
effects on the enx'iranmenc.
(Section 3(d)(3))

Registration may be suspended
immediately after an
opportunity for a hearing  if
necessary to prevent an
imminent hazard during the
time required for cancellation
or change in classification
proceedings (Section 6(c)(l)).
If an emergency exists that
does not permit a hearing
before suspension, EPA may
suspend registration
immediately, pending issuance
of a final order following a
hearing (Section 6(c)(3)).

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pier.- regu.ator, deraiiant, or aesiccant. .  .  .   '-  .ne focus of the
definition is on the intended use of the product.  Thus the definition
allows the regulation of as broad a range of chemicals as light be used to
comnat pests or to regulate plant growth.!-

     FIFRA recognizes two distinct groups of substances which comprise a pes-
ticide:  (1) active ingredients and (2) inert ingredients.  The former produce
the pesticide's effects, the latter do not.9j   FIFRA requires pesticides
containing arsenic in any fora to include in their ingredient statement the
percentage of both total and water soluble arsenic, calculated as elementary
arsenic.:°J  The statute does not otherwise single out any chemical
substances for special treatment when included in pesticides.
     'Section 2(u).  See 40 CFR 162.4(a), "Determination of intent of use,"
which states:  "A substance or mixture of substances is a pesticide under the
Act if it is intended for preventing, destroying, repelling, or mitigating any
pest. .  . .  Such intent may be either expressed or implied.  If a product is
represented in any manner that results in its being used as a pesticide  it
shall be deemed to be a pesticide for the purposes of the Act and these  regu-
lations ."

     'The term "pest" means "(1) any insect, rodent, nematode, fungus, weed,
or (2) any other form of terrestrial or aquatic plant or animal life or  virus,
bacteria, or other micro-organisms  (except viruses, bacteria, or other
micro-organisms on or in living man or other living animals) which the Admin-
istrator declares to be a pest under section 25(c)(l)."  Section 2(t).   De-
spite the broad definition of a pesticide, FIFRA identifies certain exceptions
including (1) "new animal drugs" within the meaning of Section 201(w) of the
Federal Food, Drug, and Cosmetic Act (21 USC §321(w)); (2) articles deter-
mined not to be new animal drugs by a regulation establishing conditions for
its use;  or  (3) animal feed bearing or containing an article covered by  (1)
and  (2) (21 USC §321(x)).  The term "plant regulator" means "any substance or
mixture of substances intended, through physiological action, for accele-
rating or retarding the rate of growth or rate of maturation, or for otherwise
altering the behavior of plants or  the produce thereof, but shall not include
substances to the extent that they  are intended as plant nutrients, trace ele-
ments, nutritional chemicals, plant inoculants, and soil amendments.  Also,
the term 'plant regulator' shall not be required to include any of such  of
those nutrient mixtures or soil amendments as are commonly known as vitamin-
hormone horticultural products, intended for improvement, maintenance, survi-
val, health, and propagation of plants, and as such are not for pest'destruc-
tion and are nontoxic, nonpoisonous in the undiluted packaged concentration."
Section 2(v).

     'Section 2(a), 2(m).

     l°Section 2(n)(2).

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                                   6-7

     Section 2 also defines the key criterion of FIFRA, "unreasonable adverse
effects on the environment", as follows:  "any unreasonable risk to nan or the
environment, taking into account the economic, social, and environmental coses
and benefits of the use of any pesticide."llj  The phrase "unreasonable
risk" is not further defined.

     To "protect health and the environment" under FIFRA means to protect
"against any unreasonable adverse effects on the environment" where the envi-
ronment includes "water, air, land, and all plants and man and other animals
living therein, and the interrelationships which exist among these."12-'

     Section 2(1) defines "imminent hazard" as a situation arising from the
continued use of a pesticide which results in (1) "unreasonable adverse
effects on the environment", or (2) "the unreasonable hazard to the survival
of a species declared endangered by the Secretary of the Interior under Public
Law 91-135."

Criteria for Regulator? Action

     In this section, we discuss the criteria for the four major actions which
are available to EPA under FIFRA:  Registration (or denial of it), cancella-
tion, suspension, and restrictions on use (called "classification" in 7IFRA).

     Applications for registration are to be judged according to statutory
direction (and regulations set torch at 40 CFR 162).  Generally, EPA should
approve registration if a given pesticide "will perform its intended function
without unreasonable adverse effects on the environment."13-1   The criterion
"unreasonable adverse effects on the environment" means "any unreasonable risk
to man or the environment, taking into account the economic,  social, and envi-
ronmental costs and benefits of the use of any pesticide. "lu-!   The EPA
Administrator at his discretion can require further testing of a pesticide or
can issue an experimental use permit before making a decision on an applica-
tion for registration.  The burden of proof and persuasion is on the applicant.

     If a pesticide is determined, after its initial registration, to cause
"unreasonable adverse effects on the environment," the Administrator can can-
cel it.15J  Cancellation requires notice to the persons affected and an
opportunity for a hearing to consider the need for the action.  In extreme
cases, the Administrator can suspend a pesticide's permit pending cancellation
proceedings.  There are two kinds of suspensions available -a EPA, ordinary
suspension and emergency suspension.  Grounds for ordinary suspension exist
     ^Section 2(bb>.

     liSections 2(x),

     l3Section 3(c)(5)(C).

     ^Section (2)(bb)

     1SSection 6(b).

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                                   6-8

when further use of the pesticide would create an "imminent hazard". li-1
Ordinary suspension requires that notice be sent to the registrant and a
hearing be held if requested.17J  An emergency suspension does not require
prior notice or hearing, but may only be ordered when EPA determines that an
emergency exists.1!j   The term "emergency" is not defined in FIFRA.

     EPA has another option for controlling the risks associated with pesti-
cide use.  It can c1assify the pesticide for "restricted use"  (i.e., applica-
tion only by a certified applicator) if necessary to prevent "unreasonable
adverse effects."lsj

Other Resulatorv Authority
     Sections 19 and 25 of FIFRA provide further regulatory authority over
certain pesticide chemicals.  Section 19 addresses issues of pesticide dispo-
sal and transport.  The emphasis is on the proper disposal of pesticides whose
registrations have been suspended.  Section 25 contains general authority to
register and exempt chemicals and also, in subsection  (C)(3), specific author-
ity to establish packaging standards for pesticides.

     Regulations issued under Section 25 must "take into account the differ-
ence in concept and usage between various classes of pesticides and differen-
ces in environmental risk and the appropriate data for evaluating such risk
between agricultural and nonagricultural pesticides. "*aj  The EPA Adminis-
trator has the authority to exempt from the requirements of FIFRA any pesti-
cide which is either (1) adequately regulated by another federal agency or  (2)
of a character which is unnecesary to be subject to FIFRA in order to carry
out its purpose to protect health and the environment.21-1

     Other authority granted by Section 25(c) includes the power:

          •    "to determine any pesticide which contains any
               substance or substances in quantities highly
               toxic to man";
     lsSection 6(c)(l).

     :7Section 6(c).

     18Section 6(c)(2).

     lsSection 3(d)(l).

     lcSection 25(a)(1).

     : Section 25 (b).

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                                   6-9

          •    to require pesticides to be colored or
               discolored if "such requirement is feasible and
               is necessary for the protection of health and
               the environment;"

          •    to determine and establish suitable names to
               be used in the ingredient statement; and

          •    to establish standards with respect to the
               package, container, or wrapping of a pesticide
               "in order to protect children and adults from.
               serious injury or illness resulting from
               accidental ingestion or contact".

     Packaging standards for pesticides must be consistent with those estab-
lished under the authority of the Poison Prevention Packaging Act (P.L. 91-
601). "J
JUDICIAL INTERPRETATIONS

Summary

     In ruling on controversies arising under FIFRA, few courts have set cut
constructive, substantive standards for EPA to follow in administering FIFRA
and non« of these courts has established any comprehensive set of standards
for EPA.  There are a number of reasons why this is so, including the defer-
ence given to EPA on technical matters, the standard of judicial review uti-
lized, and the burden of proof employed in these cases.  These factors, and
how they cause this lack of substantive standards, is explained first.

     Following that section, we review the case law which does exist pertain-
ing to the particular actions which EPA can take with respect to registra-
tion.  We investigate in particular detail the judicial guidance which has
been given on suspension.  For ordinary suspensions, the courts have ruled on
the nature of the suspension order (a "preliminary assessment" rather than an
ultimate resolution of the situation, such as cancellation); the basis re-
quired for suspension; the cost-benefit analysis which must be undertaken; and
the standards applicable to the definition of "-imminent hazard".  On the sub-
ject of emergency suspensions, the major case in the area has defined the tara
"emergency" and established five factors to be examined in testing for the
existence of an "emergency".  The last action discussed is cancellation of
registration--the topics considered here are:  the standards necessary for
registration in general, the delicate balancing test to be employed in cancel-
lation actions, and the differences between the standards used in reviewing
cancellation and suspension orders.  We have not included separata sections
for actions involving denial of registration or limitation on the use of
previously registered products, because few cases provide substantive guidance
in these areas.
       'Section 25(c)(3).  See discussion in Volume 3.

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                                   6-10

The Rcles of ~he Courts and EPA

     The courts have repeatedly said that they will give great deference to
EPA in its decisions, especially or. technical natters.  As stated  in
Enx'ironmenta! Defense Fund, Inc.i;- v. Blum1''- (dealing with an EPA order
al.owing licited use of Mirex to help control fire ants):

     The Court's review in this respect is highly deferential and
     presumes the agency's action to be valid.  Particularly is this
     true in cases where the agency's decision rests predominantly
     on technical and scientific data in an area where much discre-
     tion has been delegated to it by Congress.  [Citations omitted.]

EPA has been given discretion to set policy, not only find facts,  and this
discretion is particularly broad in cases involving interim relief:

     We begin with the proposition that, within broad limits, the
     administrator has latitude not merely to find facts, but also
     to set policy in the public interest.  Like most regulatory
     statutes, the FIFRA confers broad discretion on the Secretary.
     It is particularly appropriate to defer to that discretion when
     the question at issue is a matter of interim relief, as it is
     in this case.25j

One judge in the U.S. District Court for the Eastern District of Michigan,  in
Dow Chemical Company v. 31um,2C- went so far as to deny a stay of  EPA's
order for an emergency suspension even though that court would not itself
have ordered the suspension.

     This deference does not mean that courts will blindly uphold  EPA's deci-
sions.  The courts require, among other things, that EPA give adequate reason-
ing for its rulings.  In EDF v. EPA,~ '- dealing with EPA's failure to sus-
pend registrations of aldrin and dieldrin, Judge Leventhal of the  District  of
Columbia Court of Appeals stated:

     Our comments according EPA substantial policy choice and discretion are
     not to be taken as mere lip service to established principle, that is
       'Henceforth, the Environmental Defense Fund, Inc. shall  be  referred  to
       456 F.Supp. 650,651  (DC D.C. 1578).

     *5Vellford v. Ruckelshaus. 439 F.2d 598,601  (D.C. Cir.  1971)  (EPA
refusal to suspend 2,4,5-T).   See  also, EDF v. Ruckelshaus,  439 F.2d  584,596
(D.C. Cir. 1971) dealing with  refusal to suspend  DDT  registration  (".  .  .we
have recognized that it is  particularly appropriate to defer to administrative
findings of fact in reviewing  a decision on a question of  interim  relief.")
[Footnote omitted.].

     IS458 F.Supp. 650  (E.D. Mich.  1979).

     17465 F.2d 525,540-541  (D.C.  Cir. 1972).

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                                   6-11

     undercut by the need we find for better articulation. .  -  -
     Our own responsibility as a court is as a partner in the
     overall administrative process--acting with restraint, but
     providing supervision.  We cannot discharge our role adequataly
     unless we hold EPA to a high standard of articulation.
     [Footnote omitted.]


In EDF v. Ruckelshaus,**-1  while considering EPA's refusal to suspend DDT,
the court gave this excellent summary of the relationship of the courts and
SPA, but came to the same conclusion:

          We stand on the threshold of a new era in the history of
     the long and fruitful collaboration of administrative agencies
     and reviewing courts.  For many years, courts have treated
     administrative policy decisions with great deference, confining
     judicial attention primarily to matters of procedure.  On mat-
     ters of substance, the courts regularly upheld agency action,
     with a nod in the direction of the 'substantial evidence'  test,
     and a bow to the mysteries of administrative expertise.   Courts
     occasionally asserted, but less often exercised, the power to
     set aside agency action on the ground that an impermissible
     factor had entered into the decision, or a crucial factor had
     not been considered.   Gradually, however, that power has come
     into more frequent use, and with it, the requirement that ad-
     ministrators articulate the factors on which they base their
     decisions.

          Strict adherence to that requirement is especially impor-
     tant now .  . . [C]ourts are increasingly asked to review admin-
     istrative action that touches on fundamental personal interests
     in life, health, and liberty.  These interests have always had
     a special claim to judicial protection, in comparison with the
     economic interests at stake in a ratemaking or licensing pro-
     ceeding.

          To protect these interests from administrative arbitrari-
     ness, it is necessary, but not sufficient, to insist on strict
     judicial scrutiny of administrative action.  For judicial re-
     view alone can correct only the most egregious abuses.  Judi-
     cial review must operate to ensure that the administrative
     process itself will confine and control the exercise of discre-
     tion.  Courts should require administrative officers to articu-
     late the standards and principles that govern their discretion-
     ary decisions in as much detail as possible.

          Rules and regulations should be freely formulated by
     administrators, and revised when necessary.  Discretionary
      '429 F.2d 534, 597-598 (D.C. Cir. 1971).

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                                          rt.ec wita rincings or ract
     anc reasoned opinions.  When administrators provide a framework
     for principled decision-making, the  result will be to diminish
     the importance of judicial review by enhancing the integrity of
     the administrative process, and to improve the quality of judi-
     cial review in those cases where judicial review is sought.
     [Footnotes omitted.]

     The fact remains, however, that the  courts have given great deference to
decisions of the EPA.  As a result, the case law presents few rulings on sub-
stantive issues.

     A second major reason for the existence of little substantive guidance
from the courts is the standard used in deciding cases that review EPA orders
made aftar public hearing.  This standard is set out in Section 16 CD) of
FIFRA:   "The order of the Administrator shall be sustained if it is supported
by substantial evidence when considered on the record as a whole."  As stated
in ED? v .  EPA , * ' dealing wih the suspension of aldrin and dieldrin:

     The standard of  'substantial evidence1 means

          something less than the weight of the evidence  .  .  .  [T]he
          possibility of drawing two inconsistent conclusions from
          the evidence does not prevent an administrative agency's
          finding from being supported by substantial evidence.
          [Footnote omitted. ]

See also EDF v. EPA, } °J reviewing the suspension of heptachlor  and chlor-
dane.  Application of this standard means that the court must investigate  the
substantive issues only far enough to satisfy itself that there  is respectable
authority for the Administrator's ruling.  Thus, rarely will the court be  set-
ting its own standards; it will usually only look at the reasonableness  of
those established by  EPA.

     Tne third reason why courts often do not reach substantive  issues in
cases under FIFRA is  the burden of proof applicable to such cases.  "The bur-
den. of establishing the safety of a product requisite for compliance with  the
labeling requirements, remains at all times on the applicant and registrant."
EDF v. ZPA31'- (aldrin and dieldrin); EDF v. EPA31J (aldrin  and
dieldrin); ED? v. EPA33J (heptachlor and chlordane) .  See also
     2S;10 F.2d  1292,  1298  (D.C. Cir.  1973).

     30548 F.2d  998,  1003  (D.'C. Cir.  1976), cert, denied 421 U.S.  925
(1S77).

     31465 F.2d  528,  532  (B.C. Cir.  1972).

     31510 F.2d  1292,  1297  (D.C. Cir.  1975).

     33548 F.2d  988,  1004  (D.C. Cir.  1976), cert, denied 431 U.S.  925
(1977).

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                                   6-13

Dow Chemical Company v. Blum11*-1  (emergency suspension of 2,4,5-T and
Silvex).  When a court holds that the applicant or registrant has not met this
burden, it does not need to look into the merits of the action, and again a
substantive decision is often avoided.

     The purpose of this section has not been to describe the procedural
vagaries of our court system but rather to give a flavor for the many reasons
why judges often avoid substantive issues in cases dealing with FIFRA.  In the
sections which follow, we review some of the standards that the courts have
established.  Bear in mind, however, that most of the standards and criteria
for FIFRA are established by legislative and administrative action, not by the
courts.

The Standards Established for Different Actions by SPA

     The actions of EPA relevant to this review are:  denial of registration,
suspension of registration, cancellation of registration, and restriction on
use.  Most of the cases setting substantive standards have dealt only with
suspension or cancellation.  Many of the principles established with respect
to these actions are relevant to others, and so our discussion will center
around those actions for which judicial standards have been established.

Suspension

     There are two suspension of registration actions available to Z?A --
ordinary suspension and emergency suspension (suspension prior to either a
hearing or notification of the registrant).  The first case concerning an
emergency suspension fay EPA under FIFRA Section 6(c)(3) was decided only last
year.  Much more law, therefore, exists with respect to ordinary suspensions,
which will be discussed first.

     Ordinary Suspensions.  It has been held by several courts thaz:

     Although cancellation notices should issue as soon as the Sec-
     retary finds a substantial question concerning the safety of a
     registered product, he reserves the suspension power for cases
     in which serious and irreparable harm to the public health is
     likely to occur before the conclusion of the ordinary cancella-
     tion process.  Vellford v. Ruckelshaus35-1  (Dealing with EPA
     refusal to suspend 2,4,5-T).


Thus, the suspension power plays a crucial role in the set of options avail-
able to EPA.  In EDF v. Ruckalshaus (DDT)38-1 the court said:
     3*469 F. Supp. 892, 906  (E.D. Mich. 1979).

     -3S439 F.2d 598, 601-602  (D.C. Cir. 1971), quoted in Dow Chemical Com-
pany v. Ruckelshaus, 477 F.2d 1317,1319 (8th Cir. 1973) (also dealing with
2,4,5-T).

     3i439 F.2d 534, 596 (D.C. Cir. 1971).

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                                   0-14

     The formulation of standards for suspension is entrusted to the
     Secretary in the first instance, but the court has an obliga-
     tion to ensure that the administrative standards conform to the
     legislative purpose, and that they are uniformly applied in
     individual cases.

In establishing such standards, the courts have noted that the purpose of a
suspension decision, is  not to make an "ultimate resolution of difficult is-
sues," but instead to make a "preliminary assessment of the -evidence."
ED? v.  ZPA,3 7j  (failure to suspend aldrin and dieldrin); £DF v. £PA3'-!
(suspension of aldrin and dieldrin); ZDF v. ZPAi3J  (heptachior and
chiordane).

     In this last case cited, Judge Leventhal, speaking for the District of
Columbia Court of Appeals, stated:

     We note, however,  that we come to this conclusion in the con-
     text of a suspension proceeding where perforce the Administra-
     tor is engaged in making a 'preliminary assessment' of the evi-
     dence; a more careful exploration of economic impact and avail-
     able alternatives would be required to support continued regis-
     tration in a cancellation proceeding.

A distinction has been made, therefore, between the level of analysis needed
to support a cancellation order (a "careful exploration") and for a suspension
proceeding (a "preliminary assessment").

     What kind of basis i£ necessary for this "preliminary assessment"?  We
have already discussed (in the section, "The Roles of the Courts and E?A") the
"substantial evidence" standard which the courts use as their basis for re-
viewing Z?A decisions.   This is to be distinguished from the evidentiary basis
which EPA must require in proceedings before it, which is the subject of this
discussion.  The District of Columbia Court of Appeals held, in £DF v.
EPA"°J  (suspension of aldrin and dieldrin), that since general data such as
laboratory experiments on animals has been found to be sufficient to support  a
cancellation order, the same principle should apply to a suspension
     "465 P.2d 528, 537  (D.C. Cir.  1972)

     38310 F.2d 1292,  1298  (D.C. Cir.  1975)
     35548 F.2d 998,  1004  (D.C. Cir.  1976), cert. denied 431 U.S.  925
 (1977).

     ""510 ?.2d 1292,  1301-1302 (D.C. Cir.  1975)

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                                   6-15

proceeding where only a "preliminary assessment" is made.*1-1  The court  in
ESF v. EPA,1**-1 (suspension of aldrin and dieldrin affirmed) also stated
that:

          When cancer is involved, it has been stated that  "even a
          court scrupulous to the point of punctilious in deference
          to administrative latitude is beset with concern" when EPA
          makes only a short reference to carcinogenicity in denying
          suspension of substances for which a "non-trivial" link to
          cancer has been shown.  EOF v. EPA,10-1 (failure to sus-
          pend aldrin and dieldrin remanded to SPA for reconsidera-
          tion) .

Thus, where cancer is in issue, greater support for an EPA  action which
potentially endangers public health may be required.

     We have seen that general data may form a sufficient basis for an EPA
determination of suspension, but we have yet to deal with the cost-benefit
analysis which lies at the heart of such a determination.   In EDF v. EPA"*-'
(heptachior and chlordane), the court stated:

     To'evaluate whether use of a pesticide poses an  'unreasonable
     risk to man or the environment,' the Administrator engages in a
     cost-benefit analysis that takes 'into account the economic,
     social, and environmental costs and benefits of the use of any
     pesticide.'  7 USC §136(bb).

Further elucidation of this point was given in Vellford v.  Ruckelshaus"5-1
(2,4,3-7),
     ulSee also EDF v. EPA. 548 F.2d 998, 1005  (D.C. Cir.  1976),  cert.
denied 431 U.S. 925 (1977) (heptachior and chlordane).

     "2510 F.2d 1292, 1298 (D.C. Cir. 1975)

          1[Wjhere the matter involved is as sensitive and fright-
          laden as cancer,' and the statute places the burden on  the
          registrant to establish the safety of his product, we
          shall not, assuming a substantial shewing of danger,
          require the Administrator to make impossible proofs.  In
          reviewing administrative actions, courts  'cannot fairly
          demand the perfect at the expense of  the achievable.'
          [Footnotes omitted.]

     "465 F.2d 523, 537-538 (D.C. Cir.  1972).

     k"5i.8 F.2d 998, 1005  (D.C. Cir. 1976), cert, denied 431
U.S. 925 (1977).

     "S439 F.2d 598, 602  (D.C. Cir. 1971).

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                                   6-16

               In order to apply his standard to a particular
          product, the Secretary must first determine what harm, if
          any, is likely to flow from the use of the product during
          the course of administrative proceedings.   He must
          consider both the magnitude of the anticipated "nans, and
          the likelihood that it will occur.  Then,  on the basis of
          that factual determination, he must decide whether the
          anticipated harm amounts to an ' imminent hazard to the
          public.

     As stated in EDF v. Ruckelshaus (DDT),*tJ  there is

          a heavy burden on any administrative officer to explain
          the basis for his decision to permit the continued use of
          a chemical known to produce cancer in experimental ani-
          mals.  [Footnote omitted.]

The suspension power, therefore, is designed to prevent serious and  irrepara-
ble harz to public health during the cancellation litigation.*7-1  In EDF v.
EPA,1"-* the "court held:

          Judicial doctrine teaches that a court must consider pos-
          sibility of success on the merits, the nature and extent
          of the damage to each of the parties from the granting or
          denial of the injunction, and where the public interest
          lies.  It was not inappropriate for the Administrator to
          have chosen a general approach to suspension that permits
          analysis of similar factors.  3y definition, a substantial
          question of safety exists when notices of cancellation
          issue.  If there is no offsetting claim of any benefit to
          the public, then the EPA has the burden of showing that
          the substantial safety question does not pose an  'imminent
          hazard' to the public, [Footnote omitted.]

In that case, EDF was questioning EPA's cost-benefit analysis which  led to  a
failure to suspend registration of aldrin and dieldrin.  The District of
Columbia Court of Appeals ruled:

          The Administrator's mere mention of these products' major
          uses,  emphasized by the EPA, cannot suffice as a discus-
          sion of benefits. . . .

          The interests at stake here are too important to permit
          the decision to be sustained on the basis of speculative
     "'439 F.2d 584, 596 a.41  (D.C. Cir.  1971) quored in EDF v. EPA.  510
F.2d 1292, 1302 (D.C. Cir. 1975)  (aldrin  and dieldrin), and cited  in  EDF  v.
EPA, 5*8 F.2d 998,  1005 (D.C.  Cir.  1976), cert, denied 431 U.S. 925  (1977)
(heptachlor and chlordane).

     "TSee Vellford v. Ruckelshaus. 439 F.2d 598  (D.C. Cir. 1971)
(2,4,5-T); EDF v. EPA, 465 F.2d 528 (D.C. Cir. 1972)  (aldrin and dieldrin).

     "465 F.2d 528, 539  (D.C. Cir. 1972).

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                                   6-17

          inference as to what the Administrator's findings and con-
          clusions might have been regarding benefits.  Sound prin-
          ciple sustains the practice of vesting choice of policy
          with the Administrator.  Its corollary is that the speci-
          fic decision must be explained, not merely explainable, in
          terms of the ingredients announced by the Administrator as
          comprising the Agency's policies and standards.  This is
          the case even though the variables of the policy approach
          selected by the Administrator are not necessarily required
          by the underlying statute.

          Our conclusion that a mere recitation of a pesticide's
          uses does not suffice as an analysis of benefits is forti-
          fied where . . .  alternative pest control mechanisms are
          available for such use.  The analysis of benefit requires
          some consideration of whether such proposed alternatives
          are available or feasible, or whether such availability is
          in doubt.  [Footnote omitted.]U3J

     This case went on to stress the importance of an analysis of benefits
(as well as harm) by EPA.  The conclusion we can draw from this case is that
EPA has a significant burden to overcome in refusing to suspend registration
where it has been shown that public safety is threatened.

     How is EPA to decide when public safety is threatened sufficiently to
warrant a suspension?  Section 6(c) of FIFRA provides that suspension shall be
ordered if EPA "determines that action is necessary to prevent an imminent
hazard during the time required for cancellation or change in classification
proceedings."  "Imminent hazard" is defined in Section 2(1) to be a situation
which would result in "unreasonable adverse effects on the environment" or
"will involve unreasonable hazard to the survival" of endangered species.
"Unreasonable adverse effects on the environment" is also defined, in Section
2(bb), to be "unreasonable risk to man or the environment," weighing the costs
and benefits as we have already discussed.  These are fairly sterile defini-
tions, however, and the courts have given some guidance in their application.

     The leading case on the definition of "imminent hazard" is EDF v.
EPA,s '•* (aldrin and dieldrin) in which the court stated:

          But we must caution against any approach to the term "im-
          minent hazard," used in the statute, that restricts it to
          a concept of crisis.  It  is enough if there is substantial
          likelihood that serious harm will be experienced during
          the year or two required  in any realistic projection of
          the administrative -process.   [Emphasis added.]
     "'465 F.2d at 539.  Note how this dovetails with  the quotation  frcm
this case cited earlier  (in the section  "The Roles of  the Court,  and EPA")
emphasizing the need for better articulation by EPA of the  rationale for  its
actions.

     5"465 F.2d 523, 540 (D.C. Cir.  1972).

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                                   6-18

See ED? v. EPA51-' (aldrin and dieldrin); ED? v. EPA (heptachlor and
chlcrdane),3i- both of which quote from this case.  This approach seems
consistent with these prior conclusions concerning "imminent hazard to public
health" made under earlier versions of FIFRA by the Secretary of Agriculture
(then in charge of administering FIFRA) and upheld by the court in EPA v.
Ruckelsaaus (DDT)53-1:

          . .  . the most important element of an  'imminent hazard to
          the public' is a serious threat to public health,  ... a
          hazard may be 'imminent' even if its impact will not be
          apparent for many years and  . .  .  the 'public' protected
          by the suspension provision  includes fish and wildlife.
          [Footnotes omitted.]

     What we have presented here is a  brief summary of the judicial guidance
which has been given with respect to several of the major issues involved  in
ordinary suspension proceedings, namely the sufficiency of the basis required
for agency decision, what is necessary for cost-benefit analyses, and what  is
"imminent hazard".  In the next part of this section, we investigate a few  of
the issues raised by emergency suspensions.

     Emergency Suspensions

     The first case considering an emergency suspension by EPA pursuant to
Section 6(c)(3) of FIFRA is Dow Chemical Company v. Blum5"J  (2,4,5-7 and
Silvex).   An emergency suspension order may be issued prior  to a hearing and
prior to notifying the registrant if the Administrator determines that an
emergency exists.  As stated in that case,

          The term 'emergency'  is not  defined in the Act, legisla-
          tive history, regulations, or the cases.  EPA has  inter-
          preted the term to mean a threat of harm to humans and the
          environment so immediate that the continuation of  pesti-
          cide use is likely to result in unreasonable adverse
          effects during a suspension  hearing.  [Citation omit-
          ted.]S5^

The court gave this guidance concerning its role  in reviewing emergency sus-
pensions :
     s;510 F.2d 1292,1297  (D.C. Cir. 1973).

     525^8 F.2d 998,1005 (D.C. Cir. 1976), cert, denied 431 U.S.
925 (1977).

     53439 F.2d 584,597  (D.C. Cir.  1971).

     S4469 F. Sup?. 892  (E.D. Mich. 1979).

     55469 F. Supp. at 901.

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                                   6-19

          Thus, in examining the EPA decision in this case, the
          Court must keep in mind that it was the Congressional in-
          tent that potentially dangerous pesticides should be re-
          moved from the market witout delay and that EPA be given
          expanded authority to regulate pesticides.5 SJ

     In commmenting on EPA's definition of the term "emergency," the cou:
held that it was "substantially valid" but went on to say:

          Because there is no precedent for the Court to follow in
          this action, it is appropriate to define the term 'emer-
          gency' by reference to the principles and rationale for
          the granting by a court of a temporary restraining order.
          The purpose of a temporary restraining order is to prevent
          immediate and irreparable harm to the complaining party.  .
          .  during the period necessary to conduct a hearing on a
          preliminary injunction.  The definition of the  'emergency'
          by the EPA reflects this same basic rationale--to prevent
          unreasonable adverse effects on the environment during the
          time necessary to conduct a suspension hearing.  . .  .

          In light of recent cases in the analogous area of review
          of suspension orders issued after a hearing, however, the
          EPA definition requires refinement.  The Courts hold the
          standard of review in this instance is whether there is a
          substantial likelihood that serious harm will be experi-
          enced during the year or two required in any realistic
          projection of the administrative process.  By analogy ta
          this standard, the term 'emergency' should be defined as
          follows:  whether there is a substantial likelihood tnat
          serious harm will be experienced during the three or four
          months required in any realistic projection of the admin-
          istrative suspension process.  This test, coupled with the
          purposes behind the hearing requirement, suggests -he
          necessity to examine five factors:

          (1)  The seriousness of the threatened harm;

          (2)  The immediacy of the threatened harm;

          (3)  The probability that the threatened harm would result;

          (4)  Benefits to the public of the continued use of the
               pesticides in question during the suspension process;
               and
     SS469 F. Supp. at '900.  In coming to this conclusion, the court
reviewed the legislative history of FIJUA, particularly Senate Resort 92-338,
1972 U.S. Code Cong. & Adm. News 3993,3996-8; Senate Report 92-970, 1972 U.S.
Code Cong. & Adm. News 4.094; 118 Cong. Rec. 322J9-32260 (September 26,  1372).

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                                   6-20

         (5)   The nature and extent of the in.format.ion before the
               Administrator at the rime he made his decision.

         [Citations omitted.]  [Emphasis added. j'7j

     This is among the clearest, most complete set of substantive standards
any court has articulated for action under FIFRA.  Tne definition of emergency
is based on an analogy to the imminent hazard standard which we have discussed
above at length.  The five-prong analysis suggested is to be performed with
the purposes of the emergency provision and its costs (no prior hearing or
notice) in mind.  This test seems logically sound and should be specific
enough to be helpful to EPA in future situations involving potential emergency
situations.

Registration Cancellations

     This section reviews judicial standards established for orders by EPA
cancelling registration under FIFRA.  We have already established that suspen-
sions are more temporary than cancellations (see discussion under "Ordinary
Suspension").  It should be pointed out here, however, that although cancella-
tions may be more final than suspensions, they involve "less urgent considera-
tions" because of the "imminent hazard" standard applicable to suspension pro-
ceedings.  Dow Chemical Company v. Ruckelshaus (2,4,5-T).5JJ  The remainder
of this discussion will focus on some of these considerations, namely, the
standards a product must meet to be registered, the balancing test to be used
in cancellation proceedings, and the type and level of proof required.

     In Steams Electric Paste Co., v. E?A,53J a case setting aside cancel-
lation orders of a rat poison, the court summarized the standards a product
must meet in order to be registered:

          First, the product must be effective; more precisely, it must
          be at least as effective as the registrant claims it to
          be...(°J

               Second, the product must satisfy certain safety stan-
          dards.  Although the definition of the term "adulterated" in
          other legislation embodies safety considerations, in FIFRA it
          is the definition of the term "misbranded" that identifies the
          statutory standards of product safety.81-1  [Footnote omitted.]
     57i69 F. Supp. at 901,902.

     s"477 F.2d 1217, 1323 (8th Cir. 1973).

     5!461 F.2d 293, 306 (7th Cir. 1972)

     8"Note, however, that EPA may not establish minimum standards of prod-
uct effectiveness; it can only require the product to be as effective as
claimed.  S.L. Cowley & Sens Manufacturing Co., Inc. v. EPA, 615 F.2d 1312
(10th Cir. 1980).

     8 :See also Continental Chemiste Corporation v. Ruckelshaus, «-61 F.2d
335-236  (7th Cir. 1972) (dealing with snake insecticides containing lindane)

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                                   6-21

In supporting its cancellation orders in that case, EPA ralied on a balancing
of the risks and benefits based on this language from EDF v.
          The cancellation decision does not turn on a scientific
          assessment of hazard alone.  The statute leaves room to
          balance the benefits of a pesticide against its risks .
          The process is a delicate one, in which greater weight
          should be accorded the value of a pesticide for the con-
          trol of disease, and less weight should be accorded its
          value for the protaction of a commercial crop.  [Footnote
          omitted. ]

The Stearns court admitted that this standard "gives proper effect to the
statutory language" in cases involving injury caused by proper use of the
product,, but rejected it in the case before it where the harm was entirely or
primarily due to misuse.  There were no claims in this case that the product,
when used in compliance with the directions, had caused any injuries.  The
only reported harm had resulted from willful misuse (suicides) or from wanton
recklessness or at least negligent conduct (accidental ingestion) .

     In the ordinary case of a product which, although properly used, may
cause harm to the general public, it seems that even the court in Staarr.s
would permit EPA to use a balancing test as envisioned in ZHF v. Ruckelshaus,
as long as the test is properly administered.  Proper administration includes
the identification of conflicting interests so that counterbalancing factors
can be assigned appropriate weights.  The costs and benefits of all possible
decisions, including both cancelling registration and not cancelling it, must
be cons ider ed . ' : J

     One of the aspects of this balancing test is that human safety factors,
such as prevention of disease, are to be considered more significant than mere
economic factors.   Clearly, under this test, a major outbreak of a serious
disease would tip the scales over a minor economic loss.  Similarly, a large
economic loss should be more important than a very small chance of a minor
disease.  However, where the line should be drawn is not specified.  Presuma-
bly, the courts will defer to EPA's judgment as long as there is some substan-
tial evidence to support its position.
     fZ439 F.2d 564, 594 (D.C. Cir. 1971).

     "Continental Chemiste Corporation v. Ruckalshaus, 461 ?.2d 331, 336
(7th Gir. 1972) (smoke insecticides containing iindane).  "The substantive
standards, phrased in terms of protection of the public and impact on living
man, require consideration of the aggregate effect of a product's use upon the
environment, including not only its potential for harm, but also the benefits
which would be lost by removing it from the market."

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                                   6-22

     What kind of evidence or level of proof will be required is also not
specified, although the District of Columbia Court cf Appeals did indicate,  in
E3F r- EPA (DBT)S4J  that "[rleliance on general data, consideration of
laboratory experiments on animals, etc., provide a sufficient basis to
support" cancellation of registrations.  With respect to what level of proof
is required, the Eighth Circuit Court of Appeals had this to say in Dow
Cheaice: Company v.  Ruckelshaus (2,4,5-7):45j

          It is not. in accord with the statute as amended that the
          Administrator may issue a cancellation order only and
          solely upon proofs that the substance involved does not
          meet the statutory standards evolved for the safety of the
          public.  This, of course, he may do.  But he is not so
          restricted.  Since the registrant has a continuing burden
          of proof to establish that its product is entitled to
          registration, if the Administrator has a substantial doubt
          as to safety, it is his duty as well to issue the cancel-
          lation order. [Citation omitted.]  [Emphasis added.]

     The 1975 Amendments to FIFRA, however, overruled the substantial-
question-of-safety doctrine with the result that EPA is not required to  issue
a cancellation notice upon a finding that a substantial question of safety
exists.  Rather, new procedures -- such as the RPAR discussed in the
Regulatory Review ~- have been established which allow EPA to look at both
risks and benefits in a reasonably thorough way prior to cancellation
hearings.*'
      6"489 F.2d  1247,  1254  (D.C. Cir.  1973)

      t6477 F.2d-1317,  1224  (8th Cir.  1973)

      "See 45 FR 52628,  52631  (August  7,  1980).

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                                   6-23
            FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT-
                              REGULATORY REVIEW
INTRODUCTION

    This review covers the regulations for the designation and registration of
pesticides under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA).  Under FIFRA, the Administrator of EPA has the authority zo deny or
cancel registration of a pesticide, to restrict its use, or to impose specific
requirements such as special packaging or labeling if the pesticide poses any
unreasonable adverse effects.

    As of January 1, 1981, there are approximately 40,000 pesticide
formulations registered, including those originally registered under the 1947
Act, and each of these registrations expires every five years.1  The Agency
faces a formidable task of constantly reassessing and updating its decisions
as new scientific and technological data is introduced about testing methods
and hazards.

    Since the enactment of the FIFRA 1972 amendments, few of the procedures
involved in registration, cancellation, or reregistraticn have become final
rules.  EPA experience with several procedures, changes in FIFRA itself (1978
amendments), and industry reaction to the proposed requirements all have
resulted in a still evolving registration policy-.  However, through such ac-
tions as classifying active ingredients for restricted use and banning the use
of some pesticides, EPA has taken major regulatory steps under FIFRA's mandate.

OVERVIEW

    Major revisions of the regulations are taking place in three areas:

          •    Registration standards.  The Agency has published
               its Advanced Notice of Proposed Rulemaking to
               establish a registration standard system,1 based on
               1978 amendments to FIFRA.  This would change the
               registration procedures from registration for each
               product formulation to a generic approach, where
               standards will be set for each active ingredient.
     1FIFRA Section 6.

     *44 FR 76311 (December 26, 1978).

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                                   6-24
          •    Para requirements far registration.  The 1972
               amendments ro FIFRA require that EPA publish
               guidelines for registration.  Preliminary Nonce of
               data requirements was published in 1975 and various
               sections of these have been going through revision
               since then.  Final data guidelines had not been
               issued as of January 1, 1981.

          •    RPAR process.  This is the procedure by which EPA
               examines the risks and benefits of using pesticides
               which are presumed to pose adverse effects on the
               environment.  The Proposed Rules for these
               procedures, which have been undergoing revision since
               1975, were published in August 1980.3

     Many registration decisions and revisions of registrations are being made
on an interim or conditional basis as industry changes its testing methods to
comply with these ongoing changes.  These changes will be discussed later as
we review the registration procedures and criteria for registration.

     EPA is authorized to take a variety of regulatory actions with respect to
pesticides (See Exhibit 6-2).  Most of these actions relate to the
registration procedure and FIFRA's key criterion -- unreasonable adverse
effects.  At the conclusion of the review, we describe how EPA has implemented
this criterion with respect to such different actions as labeling, packaging,
classification, and RPA2 review.  Note that EPA's authority to establish
tolerance levels (or exemptions) for pesticide residues on raw agricultural
commodities derives from the Food, Drug, and Cosmetic Act and receives
detailed discussion in the FDA regulatory review.

     This review will examine the FIFRA regulations to review which pesticides
are designated as hazardous and how these decisions are reached.  We discuss
the following topics:

          •    chemical substances comprising pesticides;

          •    interagency jurisdiction;

          •    registration procedures and testing requirements;

          •    unreasonable adverse effects:  regulatory criteria;

          •    pesticides which  are regulated for unreasonable
               adverse effects on the environment; and

          •    use of pesticide  and toxicity categories.
     345 FR 52628  (August  7,  1980).

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                                   6-25
CHEMICAL SUBSTANCES COMPRISING PESTICIDES

     A pesticide* can be a single substance or a mixture of substances.
Every pesticide product contains one or more "active" ingredients which, by
definition produce toxic or behavior altering effects in one or more organisms
exposed,5 and it is well recognized that these ingredients pose hazards to
nontarget organisms too.  Other harmful-chemical substances may be present in
a pesticide product, however.  Impurities and contaminants may be introduced
as the active ingredient is manufactured.  In addition, pesticide foraulations
often include "inert" ingredients, added to improve the usefulness of the
product by acting as solvents, bait, dust carriers, fillers, wetting and
spreading agents or propellents.'  While these may be inert as pesticides,
they are not necessarily biologically or chemically inert.  They may be tcxic
themselves or may react with other ingredients or packaging materials to
produce toxic substances.  Some of these inert substances may be used in a
whole range of pesticides and thus may accumulate to a far greater
concentration in an area than any one active ingredient.  Finally, some
pesticides are unstable and may form degradation products over time.  Since
there are several sources of hazardous chemicals in a pesticide formulation,
it is important to determine how these different sources are traatad in agency
regulations.

     Until recently, EPA's policy was to register each formulated pesticide
product individually.  Many pesticide products consist of mixtures of differ-
ent proportions of the same active ingredients.  Every individual product went
through the decision process even though similar formulations had already been
registered by other producers, resulting in duplication of effort.  The Agency
has published an Advanced Notice of its new procedure for' treating groups of
pesticides with similar formulations.7  Registration standards will be
developed for each active ingredient which will summarize the Agency's
regulatory position with regard to all pesticide products containing that
ingredient.  Since the 40,000 registered pesticides contain about 1,500 active
ingredients this generic approach will be more efficient.  As of January 1,
1981, seven registration standards had been issued.
     "A pesticide is defined as either a "substance or a mixture of substan-
ces intended for preventing, destroying, repelling, or mitigating any pest,
and any substance or mixture of substances intended for use as a plant regu-
lator, defoliant or desiccant."  40 CFR 162.3(ff).  These include poisons and
repellants, fungicides, herbicides, insecticides, neaiaticides, rocenticicas,
slimicides, attractants, and antimicrobial agents.

     *40 CFR 162.3(c).  Combining pesticide substances can result in
"potentiation" or incrasing the effects of each ingredient many-fold.

     S40 CFR 162.3(t).

     744 FR 76311 (December 26, 1978).

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                                 6-26
                               EXHIBIT 6-2

            SUMMARY OF KEY REGULATORY ACTIONS "OR PESTICIDES
           Acrion

Deny or cancel registration for some
or all uses of pesticide

Classify for restricted use only

Suspend pesticide registration

Review risks posed by pesticide

Special labeling standards

Special packaging standards

Worker protection standards

Disposal standards


Conditional registration
Establish a tolerance for
pesticide on raw agricultural
commodities (not under FIFRA)
          Criteria

Unreasonable adverse effects,
40 CFR 162.11

Toxicity criteria, 40 CFR 1S2.30

Imminent hazard, 40 CFR 162

RPAR criteria, 40 CFR 162

Toxicity criteria, 40 CFR 152.10

Toxicity criteria, 40 CFR 162.16

40 CFR 170

Adequate margin of safety,
40 CFR 165

No significant increase in risk of
unreasonable adverse effects,
40 CFR 162.15

"Safe" (i.e., not adulterated)
40 CFR 180

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                                   6-27
I.NTERAGENCY JURISDICTION

    Pes-cicides are regulated by other agencies which have jurisdiction over
the control of hazardous chemicals.  DOT, for example, regulates the transport
of pesticides.  USDA and FDA regulate the amount of pesticide residues allowed
in processed foods; EPA sets tolerances for pesticide residues in raw
agricultural commodities.  Another overlapping area with FDA are pesticides
that are also used as drugs.

    For example, under 40 CFR 162, a pesticide that is offered solely for
human use, and is a "new drug,'" as defined by the Federal Food, Drug, and
Cosmetic Act (FFDCA), are exempted from the provisions of FIFRA.  The process
and requirements for obtaining registration for new drugs for human use
parallels the requirements of FIFRA.  Besides proof of the drugs' safety, com-
position, effectiveness, and proper labeling, FDA also considers the drugs'
impact on the environment through their compliance with the National Environ-
mental Policy Act (21 CFR 6).   The intent of this exemption is to lessen the
duplication of time and resources by both agencies and the sponsors of the
products in registering and regulating the use of the pesticide.9

    At this time, there is only one type of new drug that is exempted from
FIFRA.  This is a group of products used as pediculocides for the control of
human lice.  The active ingredient that qualifies the product as a "new drug"
is Lindane (gamma isomer of benzene hexachloride).  Other ingredients in the
products, which are classified as old drugs and therefore are under dual jur-
isdiction, are pyrethrins and piperonyl-butoxide.  Products under dual juris-
diction, including "old" human drugs (any that do not fit the definition of
"new drug"), and new and old animal drugs, must be approved by both agencies,
although the major information requirements are handled by one.  Interjuris-
dictional procedures are delineated through Memoranda of Understanding pub-
lished in the Federal Register.  Many jurisdictional problems are still being
worked out especially for animal drugs.ia
    *A "new drug" is defined under FFDCA, Section 201(p) as "any drug for
human use which is not generally recognized as safe and effective for use
under the conditions prescribed or recommended in the labeling."  A "new drug'
requires a new drag application (NDA), which includes the registration appli-
cation information.

    '43 FR 47215, October 13, 1978, Preamble to Proposed Rules.

    1"Personal communication with Registration Division, Office of Pesti-
cide Programs, U.S. Environmental Protection Agency, 1980.

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                                   6-2S
REGISTRATION PROCEDURES AND TESTING RE3UIRZMENTS

     The registration process and criteria are described at 40 CFR  162.7.  The
applicant must provide EPA with information to demonstrate that the pesticide
will "perform its intended function without unreasonable adverse effects on
the environment."  The information package supplied by the applicant must  in-
clude labeling information, the complete chemical formula, appropriate test
data, and the proposed use classification.  EPA uses applicant data, its own
analysis, and any other information available to approve or deny the regis-
tration of pesticides.  At a minimum, EPA can approve a pesticide registration
if the following criteria are met:*1

          •    the pesticide is effective for the uses
               claimed on the label;11

          •    the product is not misbranded and its label
               complies with the requirements of FIFRA;

          •    the appropriate test data have been submitted;

          •    the pesticide will perform its intended
               function without unreasonable adverse effects on
               the environment and when used in accordance with
               widespread and commonly recognized practice will
               not generally cause unreasonable adverse effects
               on the environment;13

          •    a tolerance or exemption from a tolerance
               requirement has been obtained;1" and
    1140 CFR 162.7(d)(3).

    12N"ote that this  does not give EPA the authority to  set minimum
effectiveness standards.  FIFRA  refers only to the  accuracy of  the labeling
and not to the broader question  of overall product  effectiveness.  Also,
section 3(c)(5) allows the Administrator to waive efficacy considerations  in
the interest of concentrating resources on questions of  health  and safety.
Thus, efficacy data  is required  only where a human  health impact  results  from
ineffectiveness of the product  (i.e., hospital disinfectants).

    :340 CFR 162.11.

    14This applies to the amount of pesticide residues which  are  allowed  on
feed or food crops.   Feed or food crops with residue contamination are  consid-
ered adulterated under the Federal Food, Drug, and  Cosmetic Act;  it  is  unlaw-
ful to sell or distribute them unless a regulation  has been set establishing a
permissible level  of  residue.  These  levels or tolerances are set by EPA.  See
FDA regulatory review in"Volume  3.

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                                  •6-29
          •    the pesticide has been approved under the
               Federal Food, Drug, and Cosmetic Act (FFDCA) if
               there are any drug claims on the label.1*

    EPA must balance the benefits of a pesticide against the environmental
risks it poses for each of its uses.  EPA considers the risks posed to nan,
beneficial animals, and the environment.  With respect to risks posed to human
health, the evaluation typically includes consideration of potential hazards
to pesticide applicators, farm workers, and oters who might come in contact
with the pesteicide during transportation, storage, and application, and
afterwards.  After this risk evaluation, the agency makes determinations
regarding directions for use, warning statements, and other restrictions
(e.g., reentry times) necessary to protect man and the environment.

    There are specific criteria which signal a pesticide for official (RPAR)
review and possible cancellation or denial of registration.  A risk benefit
synthesis is part of the RPAR process.  The Agency can require various steps,
from labeling or packaging requirements to restricted use classification, to
lower the environmental risk.  If the benefits of its use outweighs the risk
and there are no substitutes, the pesticide can be registered even if it seats
the RPAR criteria for toxicity or environmental damage.

    The burden of proving that a pesticide satisfies its registration standard
continues to fall on the applicant as long as the registration remains in ef-
fect.  The Administrator is required to cancel the registration of a pesticide
or modify the terms and conditions of registration whenever it is determined
that the pesticide no longer satisfies the criteria for registration.  A
registrant must report information about unreasonable adverse effects as soon
as such data becomes available.

Data requirements in support of registration

    EPA is currently working on specific guidelines for information to be
submitted to support the registration application.  These itemize the health
and safety data required, and the testing methods tcr be used in developing the
data.  Publication of these guidelines was required by the 1972 amend-
ments.18  An early version of the guidelines was published in 1975; a
version with major revisions was published as a Proposed Rule in 1973.  As of
January 1, 1981, none of the guidelines had been issued as Final Rules.
Meanwhile, the guidelines are applied in a case-by-case basis.
     lsThe FFDCA is administered by the'Food and Drug Administration.  The
applicant must show that the drug is safe and effective.  Drugs  for human use
are  covered by 21 USC §355'; animal drugs are covered under 21 USC  §360b.  See
FDA  regulatory review in Volume 3.

     1SFIFRA Section 3(c)(3)(a).

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                                   6-30
    The proposed outline of the guidelines which concern res- data is:17

    Subpart D:  Chemistry Requirements:   Product Chemistry

    Subpart E:  Hazard Evaluation:   Wildlife and Aquatic Organisms

    Subpart 7:  Hazard Evaluation:   Humans and Domestic Animals

    Subpart G:  Product Performance

    Subpart K:  Label Development

    Subpart I:  Experimental Use Permits

    Subpart J:  Hazard Evaluation:   Nontarget Plants and Microorganisms

    Subpart K:  Exposure Data Requirements

    Subpart 1:  Hazard Evaluation:   Nontarget Insects

    Subpart M:  Data Requirements for 3iorational Pesticides

    Subpart N:  Chemistry Requirements:   Environmental "ate

    Subpart 0:  Chemistry Requirements:   Residue Chemistry

    Subpart ?:  Data Requirements for Pesticide Disposal

    Subpart D sets out the format for reporting the formulation and analyti-
cal information on active ingredients, inert ingredients and impurities.  It
requires data from a battery of microbial bioassay test systems for the formu-
lated product or for each of the components of the formulated product to test
for genotoxic activity;  requires data on physical and chemical properties of
each active ingredient, the formulated product or the manufacturing-use prod-
uct which are being submitted for registration.  (See Exhibit. 6-3 for she data
requirements.)

Revision of Registration Procedures Now in Progress

    The Agency is revising the registration guidelines to incorporate a
generic approach called the Registration Standards System.  Under this system
EPA will evaluate each active ingredient and publish a Registration Standard
which would set the regulatory position for all pesticide products containing
that ingredient.  When the standard is in place, applicants with a new
pesticide formulation would have only to demonstrate that the product complies
    17-=
      Based on March 9, 1980 draft.

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                                   6-31
                                 EXHIBIT 6-3




 SUMMARY OF PHYSICAL AND CHEMICAL PROPERTIES DATA REQUIREMENTS IN § 153.51-10




Property
1 Color
2 Physical state
3 Odor
4 Melting point
5 Boiling point
6 Density or specific
7 Solubility
8 Vapor pressure
Test Substance by Product T-.-oe
Technical or
Purer Grade
of the Active Manufacturing- Formulated
Ingredient Use Product Product
X X
XXX
X X
X
X
gravity XXX
X
X
9 Dissociation constant X
10 Octanol/water partit
11 pH
12 Stability
ion coefficient X
XXX
X
13 Oxidizing or reducing action



14 Flammability




15 Explodafaility




16 Storage stability




17 Viscosity




18 Miscibility




19 Corrosion characteristics




20 Dielectric breakdown voltage
X




X




X




X




X




X




X
X




X




X




X




X




X




X
                              X = Data recuired

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with the requirements of the standard; the Agency will not have to go througn.
the complete decision-siaking process for each separate pesticide product.
After the standard is in place, extensive health and safety data will be
necessary only when the registrant is proposing a new use, a new chemical or
other deviations from the established standard.  EPA will develop standards
for groups of active ingredients periodically over the next ten to fifteen
years until the pesticides currently in use are covered; thereafter, standards
will be published as registrants propose pesticides containing new active
ingredients.  Seven standards had been issued through January 1, 1981.

    Kow the standards are to be developed is still in question.  FIFRA states
that currently registered pesticides are to be treated "in the most expedi-
tious manner possible," with priority given to those which result in residues
on food or feed crops.11  Among these, EPA must set priorities.  It has
identified some key indicators, such as documented adverse effects, type of
exposure, and amount of exposure.  Another factor in the decision is whether
to develop many relatively easy standards or a few difficult ones, or a mix-
ture.  EPA is also considering a cluster approach, which groups products with
the same or similar uses or which may be used as substitutes for each other if
one is found to be unacceptable.19

    Another consideration is the problem of pesticide formulations and inert
ingredients.  The application for registration must list all active and inert
ingredients contained in the product formulation.  The Agency's focus, has
been on the active ingredients, since these are included in the product spe-
cifically for their toxic effects.  An active ingredient and its associated
impurities (the combination is known as the "technical chemical") must undergo
a full range of acute, chronic and subchronic tests.:q  The inert ingredi-
ents do not, under the present registration procedure, routinely go through
these tests, but under the proposed guidelines, the formulated product itself
will be screened for acute oral, dermal and inhalation tcxicity, and for pos-
sible chronic effects in a. microfaial screening test.  If the toxicity of the
product exceeds the additive toxicity of the individual technical chemicals,
further testing of the inert ingredients and contaminants may be required.

    EPA has made the decision not to make further testing of the inert
ingredients mandatory on a routine basis because of the expense to industry
(there are approximately 1,500 inert ingredients used in pesticides currently
registered) and its judgment that the additional data produced would not
     1'FIFRA Section 3(g).

     lsi5 FR 75488  (November 14, 1980).

     2D43 FR 37339.

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                                   6-33
significantly improve the quality of decisionmaking.21  However, the Agency
is aware of the problem of possible accumulation of inert substances and thsir
long range environmental effects.  As information about these products becomes
available through efforts under TSCA and through biological screening, it has
the option of requiring testing of inerts on a case-by-case basis.22

Conditional Registration

    While the registration standard for a particular active ingredient is
being developed, pesticides containing the ingredient can be registered under
a program of conditional registration23 even if all supporting data is not
yet available.  40 CFR 162.18(2) requires that use of the product must not
cause a "significant increase in the risk of unreasonable adverse effects on
the environment".

    Conditional registration will allow EPA to convert the registrations of
older pesticides without forcing cessation of their use while it gathers the
information necessary to complete the Registration Standard for its active
ingredients.  When the Standard is published, a pesticide's conditional regis-
tration will be converted to "unconditional" registration if the pesticide is
in compliance with the standard.

    Conditional registration also enables EPA to avoid the double standard
problem that had plagued its registration program after the 1972 Amendments,
when registrants of newly proposed pesticides had to meet more rigorous data
standards than had products with the same formulation which were already
registered.  Since the 1978 amendments, a pesticide which is identical or sub-
stantially similar to a currently registered pesticide is eligible for condi-
tional registration.2*

Renewals of Pesticide Registraton

    Pesticides are periodically reviewed to update their registration in light
of current scientific and technological knowledge.  One way that this is ac-
complished is through the requirement for reregistrat ion.  The registration
of a pesticide may be cancelled after five years unless there is a specific
request that the registration be continued.25  The registrant must include
    2143 FR 37340.

    "Proposed 40 CFS 163.80-3(b) (2) (iv).

    23See 40 CFR 162.18-1 through 162.18-5 (44 ?R 27932, May 11, 1979).

    2UFIFRA Section 3(c)(7)(A).

    25?IJRA Section 6(b).

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 any  new  information  and supporting  data  with  the  application  for
•reregistration.2'  EPA expects  that many registrants  will  have  to  furnish
 new  aata ~o  comply with the  revised requirements  for  types of data and
 specific testing methods.  The  criteria  for approval  of reregistration c.re the
 sane as  those  outlined above for  the initial  registration  and include
 conditional  reregistration where  appropriate.
     Regulatory  criteria are  discussed in  more  detail  in the  following sections:

           •     Criteria for  banning  or limiting  the use of a
                pesticide discusses the RPAR criteria  and summarizes
                current  actions  under this process .

           •     Classification  for  general or restricted use
                outlines the  criteria and  requirements for
                classification  and  the different  ways  a pesticide may
                be  classified.

           •     Other  specific  pesticide requirements, such as
                special  labeling, packaging, and  worker protection.

 Criteria for  3*T..ing  or Liniting Use of a Pesticide

     R?AR criteria  and review.   EPA developed the RPAR process  to examine
 pesticide uses  which  might not  meet  registration requirements.   When there is
 reason to suspect  that  a use of a  pesticide will cause unreasonable  risk to
 the  environment , the  Administrator can make a rebuttable presumption against
 registration  or against continued  registration of  this pesticide.  This  sets
 in motion a process which brings together the interested public, industries,
 and  government  agencies to review  the available  evidence on  both hazards and
 benefits of use of the  pesticide.

     In 1975 under  regulations  ~o implement the 1972 FIFRA amendments, ZPA
 developed the criteria  which would bring  a product into rhfe  RPAR process.17

     The risk  criteria concern  the  following:

     li   Acute  toxicity to humans, domestic animals or wildlife

     2.   Chronic Toxicity
          A.    Oncogenic
          B .    Mutagenic
     2SSee 40 CFR I62.6(b)(5).

     2740 CFR 162.11.

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                                   6-35
    3.   Other Chronic Effects
         A.   Reproductive
              (1)  Fetotoxicity
              (2)  Teratogenicity
         B.   Spermatogenicity
         C.   Testicular Effects

    4.   Significant reduction in wildlife, reduction in endangered
         species, and reduction in non-target species.

    5.   Lack of Emergency Treatment or Antidote.

These general criteria have been expanded to specify levels of toxicity which
result in  a rebuttal presumption against registration or continued regulation
(Exhibit 6-4).  These criteria are a. screening mechanism to determine which
pesticides must be examined more closely before re-registration.  The general
principles of the RPAR process are described below.

    If the pesticide meets the RPAR criteria, the burden of proof is en the
registrant to rebut the presumption against registration.  The registrant nay
do this by showing:

           •    that under the terms of the registration
               proposal the anticipated exposure to the
               applicator or user and aon-target populations
               "is not likely to result in any significant
               acute adverse effects," or

           •    that the pesticide would not persist or
               accumulate in man or the environment to levels
               "likely to result in any significant chronic
               effects," or

           •    that the determination that the pesticide
               meets or exceeds the criteria for risk is in
               error.2*

    The purpose of the rebuttal presumption is to examine the Individual
characteristics of the particular pesticide and the particular types and
levels of  exposure that might result from its use.  The registrant can bring
in evidence to show that the levels of exposure required to cause acute or
chronic effects will not result from the proposed uses.  Alternatively it may
be shewn that risks can be minimized and brought into acceptable levels by
restrictions on use.  The registrant must show that the benefits of each use
of the pesticide exceed the risks of use.  The registrant can introduce
evidence on economic, social and environmental benefits.
      '40 CFR 162.11(a)(4)

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                                   6-36
                                     >~-o-r~-?-D- A'
                                     Wlb*. .*_»rv.*A
A rebuttabie presumption against registration  arises  against  a pesticide which
meets or exceeds any of these criteria  from  40  CTR  162. ll(a) (3) :
          Acute Toxicitv
               human and domest:
                     Oral
                     Dermal
                     Inhalation

               wildlife
                     mammals
                     birds
                      aquatic
                        animais
                          LDC50)
                          LD(SO)
                          LC(50)
 40 mg/kg or less
  6 g/kg or less
0.04 mg/liter or less
                                   leaves  residue  equal  to  or
                                   greater  than the  acute oral  LD in
                                   representative  test animals1
                                   leaves  residue  equal  to  or
                                   greater  than the  subacute dietary
                                   LC  in representative  test anunals
                                   reaches  concentration of more
                                   than 1/2 acute  LC for
                                   renresentative  test animals'"
     3.
Chronic Tcxicity

•    induces oncogenic effects in mammals  or humans
•    induces mutagenic effects
•    produces other chronic or delayed toxic effects
*    results in local, regional or national population  reductions
     in nontarget species
•    results in fatality to members of endangered  species

Lack of Emergency Treatments--Has no known antidotal, palliative o:
first aid treatments
      lSpecified  in  proposed Regulation guidelines.

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                                   6-37
    If the Administrator determines that the presumption against registration
has been overcome and the pesticide otherwise meets with agency requirements,
EPA will register the pesticide or continue its registration.  If there is no
evidence submitted in rebuttal or if the Administrator finds that the evidence
submitted does not meet the burden of proof, the Administrator can either move
to deny or cancel the registration, or hold hearings to determine whether the
registration should be cancelled or denied.  The decision to hold further
hearings rather than to directly issue a notice of cancellation or denial may
be influenced by any economic, social and environmental evidence suggesting
that the benefits may outweigh the risks.

    RPAR Process.  Shortly after the 1973 regulations went into effect, EPA
modified the procedures used to examine pesticides alleged to pose
unreasonable risk.  The changes were based on an ad hoc review of agency
procedures and on the 1975 amendments to FIFRA.  In its 1975 amendments
Congress required that the cancellation actions- be reviewed by two groups
before publication:  (1) by the Secretary of Agriculture who would also review
an analysis of the impact on the agricultural economy, and (2) by a Scientific
Advisory Panel.  The review panel pointed out that the trial-type procedures
used in gathering information during the RPAR process had inhibited the
participation of the public and the other federal agencies and did not provide
the right atmosphere for input by program offices into the decisicruaaking
process.

    The effect of these changes was to shift the emphasis of the RPAR review
from a process of information-gathering during formal hearings into a more
informal process where hearings are held only if a decision is challenged or
after a notice of denial or cancellation of registration is issued.  Whereas
previously the consideration of benefits, and the weighing of risks and
benefits, took place in the hearings, this is now done as a part of the RPAR
process before a notice of denial or cancellation is issued.  EPA has recently
proposed regulations2* which incorporate these changes and reflect agency
procedures developed since 1975.  The regulations outline specific procedures
for the RPAR process.  The major steps are discussed below.

    Pesticides which meet or exceed risk criteria based on evidence of "vali-
dated tests" or "other significant evidence" are nominated for RPAR.  This
wording reflects the the move away from the less rigorous "substantial evi-
dence of harm" language used in the DDT and Aldrin/Dieldrin decisions.
Nomination cannot be based on unsubstantiated evidence or on data from aisuse
of pesticides.  The risk criteria remain the same as in earlier versions; zhe
preamble of the proposed regulations mentions that.some suggestions for change
in the RPAR criteria have been suggested but that the Agency will approach
this issue separately from the issue of changes in the RPAR procedures.  The
    2S45 FR 52623 (August 7, 1980).

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                                   6-38
Administrator may also nominate a pesticide which does not meet these specific
risk criteria if there is concern that the Agency should look at a new area
where risks may outweigh the benefits.  This gives the Agency some discretion
to look at pesticides which may pose an unreasonable adverse effect in ways
not anticipated under the current risk criteria.

    The chemicals which go into a pre-RPAR review are examined by agency
scientists and contractors to determine if the risk criteria have been met.
The registrant is notified and may be asked to supply more information.  The
Agency develops a preliminary position on the potential risk which is
described in a position document (?D 1).  If the criteria are met, a formal
Notice of Presumption Against Registration is published in the Federal
Register.

    After the RPAR is issued, interested parties may submit data to rebut  the
Agency's presumptions against registration.  The criteria for rebuttal are:

          •    that the determination by the Agency was in
               error;

          •    that when used under the conditions of its
               registration, the pesticide use will not pose a
               significant risk;

          •    that the risks posed by the pesticide are not
               unreasonable taking into account the economic,
               social and environmental costs and benefits of
               the pesticide use; the registrant should show:

               (1)  that the benefits outweigh the risks, and

               (2)  that the risks cannot be further reduced
                    without unreasonable costs.

If the presumption is successfully rebutted, the Agency publishes a position
document  (?D 2) and the pesticide returns to the registration process.  It is
possible  that some uses of a pesticide can be successfully rebutted while
others must be restricted in some way.

    If no evidence is presented for rebuttal, or the presumption is not suc-
cessfully rebutted, the Agency develops a. position document  (PD 2/3) which
outlines  the risks, benefits and support for the various regulatory options
which it  can pursue.  These range from cancellation or denial to minor label-
ing changes or restrictions in use.  This document is support for the Pre-
liminary  Notice of Determination which outlines the regulatory actions the
Agency has temporarily decided to implement.  As shown in Exhibit 6-5, the
Agency has published a Preliminary Notice of Determination for nine
pesticides, as of January 1, 1981.

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                                   6-39
    If it is determined that some modifications in the conditions of regis-
tration would remedy the adverse effect, the Administrator may modify the
terms.  For instance, Section 6(b) of FIFXA specifically directs trie Adminis-
trator to consider restriction of a pesticide's use as an alternative to can-
cellation of a registration after considering the impact of cancellations on
the agricultural economy.

    The Secretary of Agriculture and the Scientific Advisory Panel review the
Agency decision.  It is Agency policy to solicit public comment at this
stage.  After considering input from these sources, the Agency adopts a final
position (PD 4) and publishes a Final Notice of Determination which outlines
its decision on regulatory action.  The Agency has published a Final Hot ice of
Determination for eight pesticides, as shown in Exhibit 6-5, through January
1, 1981.

Classification for General or Restricted Use

    Classification Criteria.  A pesticide may be classified for general use
or for restricted use.  A general-use pesticide is sold with no restrictions
on who can use it.  A restricted use pesticide can be limited to use by, or
under the supervision of, a certified applicator.  (These are individuals who
have oet federal and/or state requirements by demonstrating basic competence
and knowledge about the environment, pesticide use, antidotes and
treatments.)  Pesticide use can also be limited by other restrictions such as
seasonal or regional limitations, use in approved pest management programs, or
a requirement for monitoring residue limits after use.  Restricting the use of
a pesticide is one way by which EPA can reduce environmental risk to an
acceptable level.

    To be classified as a general-use pesticide, the product must not surpass
basic standards for human toxicity and harm to non-target organisms.  These
standards vary depending on the intended use of the product:  domestic or non-
domestic, indoor or outdoor use.  The specific standards are given in Exhibit
6-6 based on 40 CFR 162.11(c).  In addition the Administrator can classify a
pesticide for restricted use even though it would otherwise meet the criteria
for general use if the product "may pose a serious hazard to man or the
environment which can reasonably be prevented by" this restriction.33

Classification bv Active Ingredients or Groups.  The optional procedures
described at 40 CFR 162.30 provide EPA with the regulatory basis for pesticide
classification by active ingredient.  Following normal regulatory procedures
(i.e. proposal, final, revised), EPA classifies, for restricted use only, some
or all uses of:   (1), A group of products which contain common active
ingredients; or (2), a particular concentration range, formulation, or
      '40 CFS 162.11(c)(4).

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                                   6-4-0



                                 EXHIBIT 6-5

                     PESTICIDES SELECTED FOR RPAR REVIEW

Pesticide                                               Notice of Determination
                                                        Preliminary      Final

Amitraz, 42 FR 18299                RPAR COMPLETED           X             X
  (April 6, 1977)
Benomyl, 42 FR 61788                                         X
  (December 6, 1977)
BHC (benzene hexachloride), (See Lindane)
  41 FR 46024 (October 19, 1976)
Cadmium, 42 FR 56574
  (October 26, 1977)  '
Calcium arsenate, 43 FR 48267
  (October IS, 1978)
Capran, 45 FR 54938
  (August 6, 1980)
Carbon Tetrachioride, 45 FR 68551
  (October 15, 1980)
Chlcrobenzilate, 41 FR 21517        RPAR COMPLETED           X             X
  (May 26, 1976)
Chloroform, 41 FR 14588
  (April 6, 1979)
Coal tar, 43 FR 48154
  (October 18, 1978)
Creosote, 43 FR 48154
  (October 18, 1978)
DEC? (dibromochioropropane),        RPAR COMPLETED           X             X
  42 FR 48026 (September 22, 1977)
Dialla-e, 42 FR 27699                                        X
  (May 31, 1977)
Dimethoate, 42 FR 45806             RPAR COMPLETED           X             X
  (Septemer 22, 1977)
EBDC (ezhylenebisdithiocarbamates),
  42 FR 40618 (August 10, 1977)
Endrin, 41 FR 31316                 RPAR COMPLETED           X             X
  (July 27, 1976)
EPN (ethyl p-nicophenyl
  thicnobenzenephosphonate),
  44 FR 54384 (September 18, 1979)
Ethyleae dibrociide, ^4 FR 63134                              X
  (December 14, 1977)
  Source:   Special Pesticide Review  Division  Quarterly Status-Report,
February,  1981.

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                                   6-41
                           EXHIBIT 6-5 (continued)

                     PESTICIDES SELECTED FOR RPAR REVIEW
Pasticida
Ethylene oxide, 43 F3 3800
  (January 27, 1978)
Inorganic arsenicals, 43 FR 42867
  (October 18, 1978)
Kepone (Chlordecone), 41 FR 12333
  (March 25, 1976)
Lead arsenate, 43 FR 48267
  (October 18, 1973)
Lindane, 42 FR 9816
  (February 18, 1977)
Maleic hydrazide, 42 FR 56920
  (October 28, 1977)
PCNB (pentachloronitcobenzene),
  42 FR 61394  (December 7, 1977)
Pentachlorophenol, 43 FR 48443
  (October 18, 1978)
Pronamide, 42 FR 32302
  (June 24, 1977)
Silvex, 43 FR  17116
  (April 21, 1978)
Sodium arsenate, 43 FR 48267
  (October 18, 1978)
Sodium fluoroacetimide (1081)
  41 FR 52792  (December 1,1976)
Sodium fluoroacetate (1080)
  41 FR 52792  (December 1, 1976)
Sodium pyroarsenate, 43 FR 43267
  (October 18, 1978)
Scrychinine, 42 FR 2714
  (January 13, 1977)
Strychinine sulfate, 42 FR 2714
  (January 13, 1977)
                                Notice of Determination
                                Preliminary     Final
            RPAR COMPLETED
            RPAR COMPLETED
            RPAR COMPLETED
X

X
X

X
2,4,5-T, 43 FR 17116
See Silvex
X

X

X
  (April 21, 1978)
2,4,5-TC?, 42 FR 41268
  (September 15, 1978)
Taiophonate methyl, 42 FR 61970
  (December 7, 1977)
Toxaphene, 42 FR 26860
  (May 27, 1977)
Trifluralin, 44 FR 50911
  (August 30, 1979)

-------
                                   6-42
combination of these common active ingredients.31  A use is classified as
restricted if the EPA determines that the incremental risks of unrestricted
use outweigh the incremental benefits of unrestricted use,32  Exhibit 6-7
lists those active ingredients which have been classified for restricted use
under this procedure.

    Classifying substances by active ingredients does not remove the require-
ment for registration of a product, but allows certain limitations to take
effect without the lengthy risk/benefit analysis and test data required for
registration and the RPAR process.  Classification by rulemaking is based
only on an analysis of the incremental costs and benefits of restricted use,
including the specific criteria (Exhibit 6-6) ncessary for general use
classification.3 3

CTHZH PESTICIDE REGULATIONS

    Labeling Regulations.  Registered pesticide products are required to bear
labels containing adequate directions for use, warnings and cautions designed
to prevent injuries, and any additional restrictions necessary to prevent
illegal contamination of food or feed.3*

    Warnings and precautionary statements are required for pesticides accord-
ing to their "Toxicity Category", the type of toxic effects, and the first did
required.  Human Toxicity Categories are based upon the highest hazard shown
by any of five indictors:  Oral ^D-0> Inhalation !£-«, Dermal I^D-0J eye
effects and skin effects.  Exhibit 6-8 shows the criteria for the toxicity
categories.
    3540

    3140 CFR 162.30(a).

    3240 C7R 162.30(b).

    3540 CFR I62.31(b).

    34Iiabeling restrictions to prevent food or feed contamination  are
generally based on the period of time  (e.g.,  14 days before harvest) required
for the reduction of pesticide residues to approved levels or  "tolerances."
Prior to registration of pesticides for use on crops, a tolerance  or other
clearance under the Food, Drug, and Cosmetic  Act is required for any residues
which can reasonably be expected to remain on food or feed at  harvest.   See
FDA regulatory and statutory reviews in Volume 3.

-------
                                   6-43
                                 EXHIBIT 6-6

     CRITERIA UNDER WHICH A PESTICIDE MAY 3E CLASSIFIED FOR GENERAL USE
                                           ADDlication
                               Domestic
                              Nondomestic
acute dermal LD_fl
inhalation LC_Q
eye injury
sfcin irritation
oral ID
       50
subacute, chronic
or delayed effects
from single or
multiple exposure
2,OOOmg/kg
2mg/liter

no corneal opacity
eye irritation
reversible within
seven days

no acre than moderate
within 72 hours

1.5g/kg as detected

         for use

minor only
200mg/kg


16g/kg as detactad for usa
        as mist or spray

0.2mg/liter

noncorrosiva corneal
opacity reversible
within seven days
r.oncorrosive, no iora than
severe within 72 hours
N/A
minor only
Outdoor application:  A pesticide must meet the appropriate criteria above for
                      domestic or nondomestic use and:
Leaves residue    •   less than one-fifth acute LD-n in
                      mammalian test animals,

                  •   less than one-fifth subacute dietary LC.fl
                      in avian test animals, and

                  •   less than one-tenth acute LC_0 for aquatic
                      test animals.

Causes only minor adverse effects on physiology, growth, population levels or
reproductive rate of nontarget organisms.

-------
                     EXHIBIT 6-7
  ACTIVE  INGREDIENTS  CLASSIFIED FOR RESTRICTED USE
Active Ingredient
Acrolein
Acryionitrile
Aldicarb
Allyl alcohol
Aluminum phosphide
Azinphos methyl
Calcium cyanide
Carbofuran
Carbon disulfide
Chloropicrin
Cycloheximide
Demeton
Dicrotophos
Disulfoton
Endrin
EPN
Ethoprcp
Ethyl parathion
Fenamiphos
Fensulfothion
Fenthion
Fluoroactamide/1081
Fonofos
Hydrocyanic acid
Methamidophos
Methidathion
Methomyl
Methyl bromide
Methyl parathion
Mevinphos
Monocrotophos
Nicotine (alkaloid)
Oxamyl
Paraquat (dichloride)
and paraquat
bis (methylsulfate)
Phorate
Picloram
Sodium cyanide
Sodium f luoroacetate
Strychnine
Sulfotepp
Temephos
Tepp
Zinc Phosphide
Promos ed
9/1/77
9/1/77
9/1/77
9/1/77
9/7/77
9/1/77
9/1/77
8/1/79
8/1/79
8/1/79
8/1/79
9/1/77
8/1/79
8/1/79
9/1/77
8/1/79
8/1/79
9/1/77
8/1/79
8/1/79
8/1/79
9/1/77
8/1/79
9/1/77
8/1/79
8/1/79
9/1/77
9/1/77
9/1/77
9/1/77
8/1/79
8/1/79
8/1/79
9/1/77


8/1/79
9/1/77
9/1/77
9/1/77
9/1/77
9/1/77
8/1/79
9/1/77
8/1/79
Finalized
2/9/78
2/9/78
2/9/78
2/9/78
2/9/78
2/9/78
2/9/78
-
-
1/12/81
1/12/81
2/9/78
1/12/81
-
2/9/78
1/12/81
-
2/9/78
-
-
-
2/9/78
-
2/9/78
1/12/81
1/12/81
2/9/78
2/9/78
2/9/78
2/9/78
-
1/12/81
-
2/9/78


-
2/9/78
2/9/78
2/9/78
2/9/78
2/9/78
-
2/9/78
1/12/81
a/ Some or all formulations may be restricted - See 40 C7R
  162.31 for details.

-------
                                          6-46
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                                   6-47
    Besides the signal words shown in Exhibit 6-3 (i.e., Danger,  Poison,
etc.) front panel labels must also include child hazard warnings  (applicable
to all pesticide labels), a statement of practical treatment, (applicable to
the specific pesticide and its effects), and in some cases, other
precautionary statements.  Other precautionary statements include statements
regarding environmental hazards and physical or chemical hazards.
Environmental hazards are rated according to their effect upon wildlife, fish,
birds, polluting insects, and other non-target organisms.  Exhibit 6-9
contains the examples of pesticide hazards and the accompanying required
hazard statements that are included in the regulations.

    In addition, on June 5, 1980, the Agency announced a Label Improvement
Program under which it will evaluate registrations to see if significant im-
provements in health or safety can be made by labeling changes.   This program
allows the agency to look at groups of pesticides which are not up for re-
registration but for which newly available data indicate a possible hazard.
This will not be a complete evaluation of risks and benefits, which is part of
the registration/reregistration process, but allows the Agency to see if
changes in labeling and/or instructions will reduce the risks of a particular
pesticide use.  Changes made at this time will not affect the decisions to be
made during the normal reregistration process, where the overall  impacts of
the pesticide use are evaluated.

    Special Packaging Regulations.  Under Section 25(c)(5) of FTTRA, Z?A
requires special packaging for certain toxic pesticides to protect children
and adults from serious injury or illness.  Pesticides requiring special
packaging are those classified for general use (restricted uses are dealt with
on a case-by-case basis), that are labeled for residential use,  and that meet
certain toxicity criteria, which are listed below:3*

          •    acute dermal LD(50) of 2,000 mg/kg or less;

          •    acute inhalation LC(50) of 2 mg/1 or less;

          •    corrosive to the eye;3*

          •    corrosive to the skin;37
    is
      40 CFR 162.16(c)(2).
    3*Defined as causing irreversible destruction of ocular tissue or cor-
neal involvement or irritation persisting for 21 days or more.

    3rDefined as causing tissue destruction into the cermis and/or scar-
ring, or severe skin irritation (erythema or edema) at 72 hours.

-------
                                   6-48-
                                 EXHIBIT 6-9

                LABELING:  ENVIRONMENTAL HAZARDS CRITERIAij




Hazard Indicator/Category                       Required Labeling

A   Outdoor pesticide containing an active       "The Pesticide is Toxic to
    ingredient with a mammalian acute LD(50)     Wildlife"
    of 100 or less; or avian acute oral LD(50)
    of 100 mg/kg or less; or avian subacute
    dietary LC(50) of 500 ppm or less.

B   Outdoor pesticide containing an active       "This ?°sticide is Toxic ~o
    ingredient with a fish acute LC(50) of       Fish"
    1 ppm/or less.

C   Pesticides for foliar applications toxic     Appropriate label cautions
    to pollinating insects

D   Accident or field studies demonstrate        "This pesticide is extremely
    potential bird, fish, or mammal fatalities,  toxic to wildlife (fish)."

E   All outdoor uses other than aquatic uses.    "Keep out of lakes, ponds,
                                                 or streams.  Do not contami-
                                                 nate water by cleaning of
                                                 equipment or disposal of
                                                 wastes."
         CFR 162.10(h)(2).

-------
                                   6-49
          •    acute oral LD(50) of 1.5 g/kg or lass;

          •    other coxicological data, use history,
               accident data, or other evidence showing that
               special packaging could reduce serious hazards.

    The required packaging is based on effectiveness testing procedures out-
lined by Consumer Product Safety Commission protocol.11  Exemptions, which
are dealt with case-by-case, are applicable to all products of identical or
substantially similar composition and uses.

    Worker Protection Standards.  Worker protection standards are included in
the regulations to protect farm workers from exposure to hazardous pesti-
cides.  These standards are issued pursuant to Section 25 of FIFHa.  The
standards include recommendations for reentry times, warnings, protective
clothing, and special precautions.  Besides the general standard for reentry,
which requires the owner to wait until sprays have dried or dusts have settled
before allowing farm workers to enter the field, certain pesticides have been
given either exemptions or a longer reentry time.  Pesticides with the active
ingredients listed below require at least the time interval listed opposite
for reentry.3*

                              Pesticide          Hours
                         1. Ethyl parathion        48
                         2. Methyl parathion       43
                         3. Guthion                24
                         4. Demeton                43
                         5. Azodrin                48
                         6. Phosalone              24
                         7. Carbophenothion        48
                         8. Metasystox-R           43
                         9. EPN                    24
                        10. Bidrin                 48
                        11. Endrin                 48
                        12. Ethicn                 24

    Criteria and Standards for Disposal of Pesticides.  In the case of pesti-
cides whose registrations have been cancelled after having first been suspen-
ded to avoid imminent hazard, EPA must accept responsibility for their manage-
ment and ultimate disposal. • The owner, however, oust first make an effort to
    J*The special packaging must not be detrimental to the integrity of the
product; must show a child resistant effectiveness of at least 85 percent
without, and 80 percent with, a demonstration; and an adult-use effectiveness
of at least 90 percent.

    "40 CFR 170.3(b)(2).

-------
                                   6-50
return the pesticide to the manufacturer, or to another agent capable cf using
the product.  To carry out its responsibilities, EPA has established
recommended procedures for the disposal and storage of pesticides and
pesticide-related wastes.48

    FIFRA, Sections 19(a) and 25(a), gives EPA the authority to establish
regulations and procedures for the storage and disposal of pesticides or pes-
ticide containers.  The procedures in 40 CFR 165.1-165.10 are mandatory for
EPA disposal operations only and are subject to changes and revisions as
necessary to "protect public health and environment" with an "adequate margin
of safety".*1  Acceptable disposal procedures are determined by the
composition and toxicity of each type of pesticide.  Recommendations for
disposal are based on the type pesticide, type of container, and disposal
method.  Pesticides are classified according to their toxicity and persistence
in the environment:  (1) organic mercury, lead, arsenic, cadmium, and organic
pesticides; (2) other metallo-organic pesticides; and (3) nonmetallic organic
pesticides.*1  Each of these categories have disposal options, including
incineration, landfill, or soil injection with special limitations outlined  in
the regulations.  Storage recommendations take into account safety measures,
sites of storage, separation of products, and fire control.43

SUMMARY 0? PESTICIDES REGULATED FOR HAVING UNREASONABLE ADVERSE EFFECTS

    EPA has cancelled the registration of the following pesticides for all or
most uses:
              Pesticide

     DDD (TDE)
     DDT (Most uses)
     Aldrin/DieIdrin  (most uses)
     Chiordane/'Heptachlor (most uses)
     Mirex
     Chlordecone/Kepcne
Federal Register Notice
36
37
39
39
41
FR 5254
FR 13369
FR 37216
FR 41298
FR 56703
42 FR 13885
(3/13/71)
C/7/72)
(10/18/74)
(11/26/74)
(12/29/76)
(4/11/77)
     ""40 CFR  165.1-165.10.

     ":40 CFR  165.2(b).

     "240 CFR  165.8-10.

     43Storage recommendations are applicable to Toxicity Categories  I  and
II only.  Toxicity categories are determined by several hazard  indicators such
as corrosivity and I«D-n» and are outlined at 40 CFR  162.10(h)(l)  Labeling

Requirements  (see Exhibit 6-8).

-------
                                   6-51
     The Agency has issued a Notice of Intent to Cancel on the following
oesticides:
                  Pesticide

     DEC?/1, 2-dibromo-3-chloropropane1"'
     2,4,5-T/Silvex
     Amitraz/Baam
     Chlorobenzilate
     Endrin
Federal Register Notice

  44 FR 65135 (10/29/79)
  44 FR 72316 ( 3/15/79)
  44 FR 32736 ( 6/7/79)
  44 FR 9547  ( 2/13/79)
  44 FR 43631 ( 7/25/79)
    After the publication of a Notice of Intent to Cancel, the registrant or
any person adversly affected by the decision may request a hearing to review
objections.  Hearings for 2',4,5-T/Silvex began on March 14, 1930.

    A registrant may withdraw an application for registration or voluntarily
cancel registration of a pesticide use."*  The registration of the following
ingredients has been voluntarily cancelled:
                   Pesticide

Acrylcnitrile (3 products)
Aramite
Arsenic trioxide
Basic copper arsenate
Benzac/Bentazon
BHC (benzene hexachloride) (Lindane)
Chloranil
Chlordecone/Kepcne (products of 6 formulators)
Copper acetoarsenite (some products)
Erbon
Monuron (some products)
OMPA/octamethyIpyrophosphoramide
Perthane (many products)
Phenarsazine chloride
Safrole
Sodium arsenite (two products)
Strobane
Trysben
Federal Register Notice
43
42
42
42
42
43
42
42
42
45
42
41
45
42
42
42
42
43
41
43
FR
FR
FR
FR
FR
FR
FR'
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
FR
26310
19209
45944
18422
39977
31432
3702
38205
13422
58770
41320
21359
41694
59776
11039
16344.
29957
48267
26607
5782
(6/19/73)
(4/12/77)
(9/13/77)
(4/7/77)
(3/3/77)
(7/21/73)
(1/19/77)
(7/27/77)
(4/7/77)
(10/4/30)
(3/16/77)
(5/28/76)
(6/20/30)
(11/21/77)
(2/25/77)
(3/30/77)
(6/10/77)
(10/13/73)
(6/23/76)
(2/9/73)
    **E?A suspended uses of these pesticides at the tiae of the cancellation
notice.  Under a Notice of Intent to Cancel a pesticide, use of the pesticide
can continue until hearings, if requested, are complete.  Under Suspension
orders, which must be accompanied by a Notice of Intent to Cancel, further use
of the pesticide is forbidden unril the cancellation issue is resolved.  FIJRA
Section 6(c).
     '40 CFR 162.7(f)(2)(ii).

-------
                                   6-52
PESTICIDE AK3 TOXZCI7Y CATEGORIES

    Categorization of Pesticides.  The EPA must deal with the constant task
of updating testing procedures and technical information on pesticides, as
well as the continued registration of new and reregistration of old
pesticides.  The EPA has taken some steps to simplify the registration process
including classification by active ingredient, and most recently, the proposed
registration standards.  The standards have evolved from experience gained in
trying to register each product, even similar formulations, individually.
Registration standards decrease duplicative efforts by condensing i-0,COO
pesticide products into 1500 active ingredients.

    Many of the most common pesticides fall into three chemical groups:

    (1)  Organic phosphates (e.g., parathion, E?N, malathion,
         diazinon)

    (2)  Chlorinated hydrocarbons (e.g., aldrin, dieldrin, DDT,
         chiordane, heptachlor, kepone)

    (3)  Carbamates (e.g., carbyl)

    Other important pesticide groups include inorganic arsenics, cyanides,
coumarins,  indandiones, organic acids, and derivates.  Each group has its own
special health hazards, acute and/or chronic.

    In an effort to simplify and standardize as much as possible, pesticides
are categorized by the EPA.  In some cases, EPA has assigned pesticides to
categories by their effects (e.g., use classification, toxicity categories)  :.n
others, by their physical structure.

    For instance, all pesticides are divided into three categories in the
recommendations for disposal.4*  These three categories are:

    (1)  organic mercury, lead, cadmium, and arsenic containing
         compounds and inorganic compounds;

    (2)  other metallo-organic compounds; and

    (3)  organic compounds.

  .  These groupings are useful in establishing disposal procedures because
members of a group require similar disposal and precautions.  However, these
groups may or may not be useful in, for instance, establishing tolerances or
    u!40 CFR 165.1.

-------
                                   6-53
for labeling purposes.  Instead, pesticide tolerances on raw agricultural
commodities are set by the nature of their residues; some pesticides ara
grouped according to their pharmacological effects:  chlorinated organic
pesticides, arsenic containing chemicals, metallic diothiocarbamates,
cholinesterase-inhibiting pesticides, and dinitrophenols."7  Exhibit 6-10
outlines these categories.

                                 EXHIBIT 6-10

                      ONE CATEGORIZATION OF PESTICIDES
I.
      Disposal Groupings

     Organic (nonznetallic)
     pesticides
II.  Metallorganic (except
     lead, cadmium, mercury
     and arsenic) pesticides
Tolerance Groups That Would 3e Included

 a.  Chlorinated organic pesticides
 b.  Dinitrophenols
 c.  Diothiocarbonates (partially)
                                       a.  Diothiocarbonates (partially)
                                       b.  Copper compounds (partially)
                                       a.  Arsenic containing compounds
III. Organic mercury, lead,
     cadmium and mercury
     compounds,  and inorganic
     pesticides

    Toxicity Criteria.  The overriding FIFRA criterion of "unreasonable ad-
verse effects" needs further specification when used in regulatory efforts.
Although the reasonableness or unreasonableness of the risks posed by the pes-
ticide must be determined through a case-by-case balancing of the risks and
benefits, it is  feasible and desirable to establish generic toxieity criteria
to identify "adverse effects."  Likewise, EPA has adopted generic; toxieity
criteria for the RPAR review process.  Unlike the other generic toxieity cri-
teria, the RPAR criteria are rebuttable and do not predispose regulatory out-
comes in the absence of a cost-benefit balancing.  Hazard classifications have
been developed for other toxics programs (EPA and non-SPA) and are compared in
Volume I of this report.

    As shown in Exhibits 6-11 through 6-15, toxieity parameters for FI7RA are
somewhat standardized across regulatory categories.  Labeling and use
classifications, for instance, generally utilize the same toxieity
categories.  However, SPA has let the purpose and need of the standard
determine the appropriate toxieity criteria even at the necessary cost of some
inconsistency.  This can be clearly seen in the Exhibits.
     740 CFR 180.3.

-------
6-5«
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                                   6-59
                                      APPENDIX A

          PESTICIDE PRODUCTS CONTAINING THE ACTIVE INGREDIENTS LISTED 3ELCW
       HAVE BEEN CLASSIFIED FOR RESTRICTED USE FOR ONE OR MORE REGISTERED USES
Active Ingredient

Aerolein
Acrylonitrile




Aldicarfa


Allyl alcohol

Aluminum phosphide



Azinphos methyl



Calcium cyanide



Derneton
 Formulation

As sole active ingredi-
ent.  No mixtures
registarad.
In combination with
carbon tetrachloride.
No registrations.
As sole active
ingredient

All formulations

As sole active ingredi-
ent.  No mixtures
ragisterad.

All liquids with a con-
centration greater than
13.5 percent.

As sole active ingredi-
ent.  No mixture
registered.

All granular formula-
lations, emulsifiable
concentrates and con-
concentrated solutions.
Criteria
Influencing Restriction

Inhalation hazard to
humans.  Residue effects on
avian species and aquatic
organisms.

Other hazards--accident
history of both acryloni-
tril and carbon zetra-
chloride products.

Other hazards--accident
history.

Acute dermal toxici.y.

Inhalation hazard to
humans.
Inhalation hazard to
humans.
Inhalation hazard to
humans.
Domestic uses:  Acute
oral toxicity.  Acute
dermal toxicity.  Non-
dcmesric outdoor uses.
Residue effects on avian
and mammalian scecies.

-------
                                  . 6-60
                                  APPENDIX A
      PESTICIDE PRODUCTS CONTAINING THE ACTIVE INGREDIENTS LISTED BELOW
   HAVE BEEN CLASSIFIED FOR RESTRICTED USE FOR ONE OR MORE REGISTERED USES
Active Ingredient
 .>• ennui at ion
Influencing Restriction
                                                    Acute dermal toxicity,
                                                    Residue effects on mammal-
                                                    ian and avian soecies.
Ethvl oarathion
                          All emulsions, dusts,
                          wettable powders,
                          pastes, and granular
                          formulations.
                          Acute dermal tcxicity.
                          Hazard to nontarget
                          organisms.
                          Hazard to nontarget organ-
                          isms.  Inhalation hazard to
                          humans.  Acute deraal tax-
                          icity.  Residue effects on
                          mammalian, aquatic, avian
                          species.
Fluoracetamide/1061
Hvcrocvanic acid
Methomyl
As sole active ingredi
ent in baits.  No mix-
tures registered.

As sole active ingredi
ent.  No mixtures
registered.

All granular formu-
lations
Acute ora] toxicity.
Inhalation hazard to
humans.
Residue effects on mammal-
ian species.   Other hazards
--accident history.

-------
                                   6-6i
                                  APPENDIX A
                                 (Continued)

      PESTICIDE PRODUCTS CONTAINING THE ACTIVE INGREDIENTS LISTED BELOW
   HAVE BEEN CLASSIFIED FOR RESTRICTED USE FOR ONE OR MORE REGISTERED USES
Active Ingredient
Methyl bromide
Methyl parathion
Mevinohos
  Formulation

 In 1.24. percent to 2.5    Same.
 percent dusts as sole
 active ingredient and in
 mixtures with fungicides
 and chlorinated hydro-
 carbon, inorganic phos-
 phate and biological
 insecticides.

 All formulations in con-  Same.
 tainers greater than
 1.5 Ibs.  Containers
 with not more than 1.5
 Ibs.  of methyl bromide
 with 0.25 percent to 2.0
 percent chloropicrin as
- an indicator.  Container
 with not more than 1.5
 Ibs.  having no indicator.
All formulations.
all emulsifiable con-
centrates and liquid
concentrates.
2 oercent dusts.
                          Criteria
                          Influencing
                           Other hazards--accident
                           history.   All foliar
                           applications restricted
                           based on residue effects
                           on mammalian and avian
                           species.   Residue effects
                           on avian species.   Hazard
                           to bees.   Acute deraal
                           toxicity.  Residue effects
                           on mamallian ar.d avian
                           species.

                           Same.
                           Acute dermal toxicity.
                           Residue effects on mammal-
                           ian and avian species.

-------
                                  APPENDIX A
                                 (Continued)

      PESTICIDE PRODUCTS CONTAINING THE ACTIVE INGREDIENTS LISTED BELOW
   HAVE BEEN CLASSIFIED FOR RESTRICTED USE FOR ONE OR MORE REGISTERED USES
Active Ingredient

Paraquat (dichloride)
  aad paraquat
  bis(methyl sulfate)
Picicraa
 jormulation

Ail formulations and
concentrations except
those listed below.
Pressurised spray formu-
lations containing 0.44
percent Paraquat
bis(methyl sulfate) and
15 percent petroleum
distallates as active
ingredients.

Liquid fertilizers con-
taining concentrations of
0.025 percent paraquat
dichloride and 0.03 per-
cent atrazine; 0.03 per-
cent paraquat dichloride
and 0.37 percent atrazine,
0.C4 percent paraquat di-
chloride and 0.49 percent
atrazine.

All formulations and
concentrations except
tordon 101 R (forestry
herbicide containing
5.4 percent picloram
& 20.9 percent 2,4-D).
Criteria
Influencing Restriction

Other hazards.  Use and
accident history.  Human
toxicological data.
Hazard to nontarget organ-
isms (specifically nontar-
get plants both crop and
noncrop.

-------
                                     1-1
                       CLEAN AIR ACT--STATUTORY REVIEW
OVERVIEW OF THE ACT

    The Clean Air Acr (CAA) is a. comprehensive attempt to address the nation's
air pollution problems.  The legislation was first enacted as the Clean Air
Act of 1963.  Significant amendments include the Clean Air Act of 1970 and the
Clean Air Act Amendments of 1977.  The CAA creates a series of programs
through which the Environmental Protection Agency (SPA) is authorized to pro-
mulgate regulations to "protect and enhance the quality of the nation's air
resources.  ..." (42 USC §7401).

    The provisions for regulating air pollutants may be grouped  into two
classes:  air quality standards and emission standards.

    Sections 108-109 authorize EPA to determine the levels at which air pol-
lutants can safely be tolerated in the atmosphere and to establish national
ambient air qualify standards (NAAQS).   Control strategies, ("implementation
plans') for emissions sources are developed on a pollutant-by-pcilutant and
state-by-state basis.  State plans must demonstrate that concentrations of
regulated pollutants in each air quality control region will not excaed the
national ambient air quality standards by the statutory deadlines.

    Other sections of the CAA (i.e., Ill, 112, 157, 202, 211, and 231) autho-
rise EPA to control pollution at the source by establishing uniform national
emission limits and standards.  Among them are the New Source Performance
Standards (NSPS), the Federal Mobile Source Emission Standards, National
Emission Standards for Hazardous Air Pollutants, and the regulation of
pollutants which may damage the ozone layer.

    The following provisions of the Clean Air Act are examined in this statu-
tory review:

         *    Section 108--Air Quality Criteria

         •    Section 109—National Ambient Air Quality Standards

         •    Section 110--State Implementation Plans

         •    Section 111--New Source Performance Standards

         •    Section 112--National Emission Standards for
              Hazardous Air Pollutants

         •    Section 122—Certain Unregulated Pollutants

         •    Section 157--0zcne Protection

-------
         •    Section 2C2--Motor Vehicle Emissions

         •    Section 211--Regulazicn of Fuels

         •    Secrion 231--Aircraft Emissions

A summary at the end presents an overview of the statutory criteria  and  EPA's
regulatory alternatives.

SECTIONS 108-109:  NATIONAL AMBIENT AIR QUALITY STANDARDS (XAAQS)

    Tne procedure for issuing National Ambient Air Quality Standards  is  out-
lined in the Clean Air Act.  The three distinct stages of this procedure are:

         (1)  Listing air pollutants in the Federal Register;

         (2)  Issuing air quality criteria; and

         (3)  Proposing and promulgating primary and secondary
              ambient air quality standards.

Each of these stages is summarized below.

    Listing.  Section 108(a)(l) directs EPA to list each air pollutant:

     "(A) emissions of which, in [the Administrator's] judgment,
     cause or contribute to air pollution which may reasonably be
     anticipated to endanger public health or welfare;

     (B) the presence of which in the ambient air results from
     numerous or diverse mobile or stationary sources; and

     (C) for which air quality criteria had not been issued before
     the date of enactment of the Clean Air Amendments of 1970, but
     for which it plans to issue air quality criteria under this
     section."1

    In general terms, the effects of pollutants on public health and public.
welfare and the number and diversity of sources emitting a particular air
poliu~ant are the statutory criteria used by EPA to list substances  under Sec-
tion 108.  The Second Circuit Court of Appeals has decided that if  an air
pollutant meets conditions (A) and  (3), it must be listed by EPA under
     4.2 USC  §7408  (emphasis  added) .

-------
                                   7-3
Section 103.  The Court pointed to the statutory-language and legislative
history of the Clean Air Act as support for this position.2

    Although criterion (3) is relatively objective, criterion (A) specifically
requires an exercise of judgment based on a three-part test.  To be  listed
emissions of a pollutant must:

         (1)  "cause of contribute to air pollution" which

         (2)  "may reasonably be anticipated" to

         (3)  "endanger public health".

    Congress meant to require the EPA "to consider all sources of the con-
taminant which contribute to air pollution and to consider all sourcas of
exposure to the contaminant--food, water, air, etc.--in determining  health
risk."3

    The phrase "cause or contribute" authorises  listing of a substance even  in
the absence of definitive human or animal data which demonstrate a causal
relationship between the polluting chemical and  health effects. This allcws
the agency to make judgments about chemical substances based on suggestive
epidemic logical data or case reports.

    The phrase "reasonably be anticipated" likewise requires less than com-
plete certainty with respect to, for example, dose-response effects.

         In evaluating what "may reasonably be anticipated," the
         limitations and difficulties inherent in environmental
         medical research . . . must be considered.*

    The phrase "endanger public health" has been the subject of litigation and
Congress has explained its intent in using this  phrase:   "In order to
    * Natural Resources.Defense Council,  Inc..  et  al. v. Russell Train,  411
F.Supp. 864  (S.D.N.Y.,  1976), aff'd., 545 F.2d  320  (2dCir.,  1376).   See also
Indiana & Michigan Electric Co. v. EPA. 509 ?.2d 339, 841  (dicta)  (7th Cir.
1975); Kenneeott Coooer Cora, v.  SPA. 462 F.2d  846,  857  (D.C.  Cir.  1372)
(dicta); but cf. St. Joe Minerals Com, v. EPA. 508  ?.2d 743,  74i  a.  3  (3d
Cir. 1975), vacated as moot, 	 U.S. 	; 48 L.Ed. 2c  312  (1976).

    3 H.S. Rpt. No. 95-294, p. 51, Legislative  Historr of  Claan Air Act
Amendments of 1977, p.  1518.  [Emphasis added.]

    * Ibid.

-------
emphasise the precautionary or preventive purpose of the  [CAAj  (and, there-
fore, the Administrator's duty to assess risks rather than wait for proof  of
actual harm) ,  the committee not only retained the concept of endangermenr  to
health.; the committee also added the words "may reasonably be anticipated",5

    These key phrases are used throughout the CAA and they are  reviewed  in
more detail later.

    Air Quality Criteria.  Within 12 months after listing an air pollutant,
the Clean Air Act instructs EPA to issue air quality criteria for the pollu-
tant.  Air quality criteria must, "accurately reflect the latest scientific
knowledge useful in indicating the kind and extent of all identifiable effects
on public health or welfare which may be expected from the presence of such
pollutant in the ambient air, in varying quantities".5

The Act suggests that the air quality criteria include information on:

         "(A)  those variable factors (including atmospheric
              conditions) which of themselves and in combination
              with other factors may alter the effects on public
              health or welfare of such air pollutant;

         (3)  the types of air pollutants which, when present in the
              atmosphere, may interact with such pollutant to
              produce an adverse effect on public health or welfare;
              and

         (C)  any known or anticipated adverse effects on'
              welfare".7

EPA may revise the criteria to include new scientific information at any time.
The sole purpose of air quality criteria is to document the scientific basis
for regulating a particular chemical under Section 109 of the Clean Air  Act.

    National Ambient Air Quality Standards.  Section 109 of the statute
requires EPA to propose regulations prescribing national primary and secondary
ambient air quality standards (NAAQS) for each air pollutant for which air
quality criteria have been issued.  Primary ambient air quality standards  are
intended "to protect the public health," while secondary standards are
intended to protect public welfare.
      -bid-

    * Clean Air Act, Section  108(a)(2).

    7 Clean Air Act, Section  108(a)(2)(A-C)

-------
                                   7-5
     NAAQS for each pollutant are proposed with the issuance of the criteria
document and included in Title 40 of the Code of Federal Regulations as Part
50.  Pollutants for which NAAQS have been promulgated are referred to as
"criteria pollutants".

     According to the statute, NAAQS oust be based exclusively on air quality
criteria issued by ZPA for each air pollutant.  The Act does not require EPA
to consider costs of achieving the standards or the feasibility of implement-
ing the standards.  Moreover, the legislative history of the Claan Air Act
firmly advises that such issues are "not germane" to the determination of
NAAQS.1  Recently the Court of Appeals for the District of Columbia riled
that the language 'and legislative history of Section 109 made it clear chat
economic and technological feasibility considerations are apt to be factors
in promulgating NAAQS.'

     The level of protection which these standards must provide is stipulated
in the CAA.  Primary standards must be set conservatively, "allowing an ade-
quate margin of safety"  requisite to protect the public health" from the
effects documented in the air quality criteria.  As one Court has stated:  "It
is irrelevant that the current state of scientific knowledge may make it dif-
ficult to set an ambient air quality standard.  The [EPA] Administrator mist
proceed in spite of such difficulties."1'  The statute does not define the
terms "adverse health effect" or "adequate margin of safety."

     In establishing primary standards, EPA has not defined the term "adequate
margin of safety" explicitly:" In issuing the ozone standard for photochemical
oxidants, the agency announced that the decision about what standard protects
public health with an adequate margin of safety "is based on the uncertainty
that any given level is low enough to prevent health effects, and on the rela-
tive acceptability of various degrees of uncertainty, given the seriousness of
the effects."11  The  legislative history of the Act indicates that providing
      * A Legislative History of the Clean Air Act, 93rd Congress,  2nd
Session, January  1974 (hereafter referred to  as  Legislative History)  and  43
FR 26963 (June 22, 1978).

      ' Lead Industries Association v. SPA. 14 ESC  1906, --- ?.2d  ---  (Z.C.
Cir. 1980), cart. den. L5 ESC 2097  (1980).

     111 NR3C v. Train, 545 F.2d 320, 324n.5 citing  as  support A
Legislative History of the Claan Air Act Amendments of 1970, Vol.  1,  p. 411
(1974).

     11 44 FR 8215.

-------
a margin cf safety means primary ambient air standards must pro-race  against:
hazards which research has not ye: identified such as synerristic  effaces. :-

     In the case cf most air pollutants, "here is no clear threshold for
adverse health effects.  This uncertainty necessitates the determination  of  an
adequate margin of safety, and forces EPA to stake assumptions and  estimations
after considering all available scientific evidence.  In the past, primary
standards have been set at acre restrictive levels than those concentrations
implicated in the criteria document as associated with adverse health effects;
however, there is no general or consistent rule applied to all pollutants by
which EPA determines an adequate margin of safety.  See Exhibit 7-1.

     The EPA's approach to setting a margin of safety for airborne lead also
was litigated in Lead Industries Association. Inc.. v. EPA.  Each
conservative assumption used in setting the standard was challenged  as being  a
aargin cf safety and the cumulative effect was criticised as resulting in too
stringent s. standard.  The court, however, rejected this characterization
because some of EPA's decisions were questions of scientific judgment (not
allowances for safety) and none of those decisions were arbitrary  and
capricious.  Econooic and technological feasibility considerations were also
ruled not to be factors in establishing a margin of safety.13

     The legislative history of the Clean Air Act indicates that EPA, when
establishing primary standards, is to direct its efforts at groups cf "partic-
ularly sensitive citizens such as bronchial asthmatics and emphysematics  who
in the course of daily activity are exposed to the ambient environment.":"

     The Court also held that Congress directed the EPA to protect against
effects which "have not yet been uncovered by research and effects whose  medi-
cal significance is a natter of disagreement."  The Court found that the  pro-
vision for an adequate nargin of safety to "protect against unknown  dangers.
supports this conclusion.1'  The statutory provisions and legislative history
convinced the Court tnat Congress wanted the EPA to err on the side  cf caution
in aaking the necessary decisions.  Thus, it rejected the argument that a
standard need orotect against only health effects that ars "known  to be
clearIT harmful."15
      ~~ Legislative History, p. 410.

      15 lead Industries Association.  Inc. v. EPA,  Ibid.

      •* Legislative History p. 410.

      iS Lead Industries Association.  Inc. v. EPA.  14  E?>C  1906,  1924 (D.C.
Cir.  19SC).

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                                                            7-7
                                                         E2HI3I7  7-1
                                    • EfrSCTS THRESHOLD. JEST CHOICS SIGNIFICANT RISK tSVSU AND  SAFsTY
                                  MAACJNS CONTAINED IN  PRIMARY AMBIENT AIR QUAUTY STANDARDS
                         thmHata1  «
                           100 aq/it?	 Aim oil  	 ln«r««i«d if«qu«n«T at  eimm« brvMrntii	  7S uq/nr*....         33
                      	 [Q uq/fw3	 24 naar	 Inarvos*^ 'mt'««ii»m in  «siiiivwlics	  Nan« 	      Nan*
                           IS ttq/ffW	 AHAVAJ  	 lnor««s«d !av«f rvieir>*ory int««tiaiH in aii*ar«n	  Man*  	      Nan*
                      	 144 uq/mJ  	a'o	 !ncr>«»d uvvrity «>' j«ur>  rneirotarY  i!U>*« in• uiiarvn	  100  uq/m*...         40
O>aa«  flMMiria*	 23 nq/nW   	 t Saw	 Dimmi»'. ...     **130
                           71 uq/W	 1 haar	 Ciwinn»*d tiarana  lai«T«««» m Wari pativnn	  40 iiq/m> ...      **S2
                   »	200 iiq/mJ	oo	 IwraaviW una^iiBiliiy  la in{*«riafi	  li«>  uq/iw5 ..         2S
         nwi^m Mwil tt?»«rt HwMMid minm i»mdwd ^"^ ^ <«•"«*« ^ "»•
  •* S.;»iy «ur^ni< b*i«^ vpm c«u«iyn.i»>ni<»b«« l*rai« »i>ii> b« 100 |>«mnl far DM
 rd M4 4'
120 CONG. lire. 18973 (1974)  (report of Drs.  Finklca, Hammer &  Cole).

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                                   7-3
     Likewise, the Court found that the mere fact that the pivotal  health
effects (i.e., blood lead elevation) relied upon in setting the  lead  standard
ars "subclinical"1' does not detract from their significance  for human
health.  The court held that these effects are a proper basis  for setting  a:.r
quality standards because of their relationship to more serious health  effects
particularly in children, who are very sensitive to lead exposures.   The Court
of Appeals case found that "the widespread presence of this toxic metal [lead]
in the environment poses a significant health risk."

     Thus, to develop primary standards EPA must:

         (1)  specify the significance (i.e., nature and severity)
              of the health effects;

         (2)  characterise the sensitive population;

         (3)  determine the probable adverse health effect level in
              sensitive persons; and

         (4)  estimate the level below the probable effect level
              which provides an adequate margin of safety to  reduce
              or eliminate the risk.

    Secondary standards must "protect the public welfare from  any known or
anticipated adverse effects" of a pollutant.17  EPA has interpreted the
requirements of Section 109 to mean that secondary national ambient air qual-
ity standards "are necessarily limited to demonstrable or predictable effects
which can be quantitatively related to pollutant concentrations  in  the  ambient
air."11  In the case of ozone, however, EPA did not have or require
quantitative data relating the cause and welfare effect.1*

    The Agency also explicitly specifies that secondary standards be  estab-
lished to protect the public welfare from adverse effects, rather than  from
all effects.20  As a result, welfare effects of a particular  air pollutant
     1(  "Subclinical" effects  can be  detected only through  laboratory tests
and  not through observation or physical  examination.

     17  CAA  §109 (b)(1),  (12);  42 USC  §7409  (b)(1), (2).

     11  Preamble to the  National Primary  and Secondary  Ambient  Air Quality
Standards for  Sulfur Oxides,  38 FR 25579 (September  14,  1973).

     ls  See  44  FR  3217  (February 8, 1979).

     ia  Ibid.

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                                   7-9
revealed by quantitative data must further be shown to-be adverse before
secondary standards will be established based on them.

     Section 302(h) of the Act defines adverse public welfare affects as
including, but not limited to, "effects on soils, water, crops, vegetation,
man-made materials, animals, wildlife, weather, visibility, and cliaate, dam-
age to and deterioration of property, and hazards to transportation, as well
as effects on economic values and on personal comfort and well being".
Because'secondary standards are designed to protect welfare in addition to
health, they are set at more restrictive levels than primary standards.
Effects on economic values refers to the economic costs of pollution, net
complicance costs.

     There are no generic specifications in the statutory previsions far
issuing short-term or long-term standards.  EPA has promulgated both types of
standards; the Agency interprets the Clean Air Act to require a short-earn
standard only if the scientific evidence presented in the criteria document
warrants such protection.11  The 1977 Amendments directed SPA to establish a
three-hour standard for NO. concentrations unless there is no significant
evidence that such a short-term standard is "requisite the srctact the public
health."22

SECTION 110:  STATS IMPLEMENTATION PLANS (SIPs)

  	Ihfl-intent of. national primary and secondary" ambiemr air-quality standards-
is to control air pollutants with a broad national impact.  3y providing a
minimum standard for air quality across the nation, NAAQS. regulates chemicals
emitted from widely distributed sources and present in the ambient air in all
areas of the United States.  It was Congress1 intention that the states should
play a large role  in the implementation and enforcement of the NAAQS.2S
Each state is responsible for the submission of a state implementation plan
(SIP) which describes the methods by which the individual state intends to
meet the NAAQS in  the air quality control regions within its jurisdiction.
The states have latitude in the design of the SIPs, but each SI? must be
approved by SPA.   If necessary, EPA will develop a plan for a state.  EPA
cannot require a level of control technology that is technologically and
economically infeasible.2*
     21 Ibid.

     22 CAA  §109(c); 42 USC 7409(c).

     23 CAA  Section  1, 42 USC §7401.

     24 Bunker Hill  Co. v. SPA,  S72 ?.2d  1286  (9th Cir.  1977).

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                                   7-10
     SIPs are the primary mechanisms through which NAAQS ars ~o be achieved.
Under the CAA, states may issue more stringent ambient air standards than the
national standard*.  Additionally, states may establish ambient air quality
standards far pollutants not included in the national standards.  The states
are not required to establish unifora emission limits for existing sources of
criteria pollutants with the exception of certain volatile organic compounds
subject to regulation under Control Technique Guidelines (CTGs).  While states
may consider economic and technological feasibility in selecting a mix of
control devices, they must nevertheless develop a plan to meet the strict
deadlines for attainment of the NAAQS.  The primary standards are to be
achieved first; secondary standards are to be achieved as soon as practicable
after achievement of the primary standards.   Moreover, in reviewing state
implementation plans, the EPA may not consider economic or technological
feasibility.2S

     In upholding the use of a particular air dispersion model for S00 e=is-
                                                                     *.
sions limits included in a SIP, the Sixth Circuit Court of Appeals noted that
if the model did over-predict emission rates, "such a conservative approach in
protection of health and life was apparently contemplated by Congress" in
requiring that emission limits be established "to insure attainment and main-
tenance of national ambient air standards."st

SECTION 111:  NEW SOURCE PERFORMANCE STANDARDS (HSPS)

     To facilitate the achievement of NAAQS, EPA is authorized to set emis-
sions standards for all newly constructed significant sources of pollution.
Section lll(b)(l)(A) of the CAA instructs EPA to list all categories of
stationary sources which are determined by the Agency to "cause or contribute
significantly to air pollution which may reasonably be anticipated to endanger
public health or welfare".27  For each category cited, EPA oust establish e.
unifora federal standard of performance to apply to all newly constructed or
modified stationary sources.

     The principal purpose of NSPS is to assure thai over the long-term
industrial development will not degrade the quality of the air.  Additionally,
these standards are intended to assure that new sources do not cause
significant air pollution problems which prevent the attainment of National
Ambient Air Quality Standards.21
     2S See Union Electric v. EPA. *27 U.S. 246, 257-S, 265-266  (1976).

     2t Cleveland Electric Illuminating Co. v. EPA. 572 T.2d 1150  (6th Cir,
1970), cert, den. <-39 U.S. 910  (1978).

     27 CAA Section 111; <+2 USC §7411.
     11 A Legislative History of the Clean Air Act, p. 227.  See  also
National Asohalt Paving Association v. Train, 539 r.2d 775  (B.C.  Cir.  1976).

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                                   7-11
     NSPS are functionally different from NAAQS in four ways.  First, the
definitions in the statute indicate, that emissions limits of NSPS are nor a
stringent than those that would exist under NAAQS.  Standards of performance
under NSPS oust reflect the "best technological system of continuous emission
reduction" which SPA determines "has been adequately demonstrated."  To be
adequately demonstrated, the pollution control technology sust be available at
a cost and at a time which EPA determines to be reasonable.

     When establishing standards of performance, SPA must consider:

         •    the cost of achieving the emission reduction, and

         •    any non-air quality health, environmental, and
              energy impacts.2 9

     Second, NSPS regulate emissions rather than overall air quality levels.
Third, NSPS are directed towards specific types of pollution sources (i.e.,
categories of pollution sources which emit dangerous pollutants).  The phrase
"cause or contribute significantly to air pollution which may reasonably be
anticipated to endanger public health or welfare" has the same aeaning as in
Section 109.  Fourth, NSPS may also be design, equipment, work practice or
operational standards.  (S«e 111(a)).

     Finally, Section lll(d) extends the treatment of new sources to existing
sources, under certain circumstances.  If an NSPS is issued for a substance
not listed under Sections 108(a) or 112(b), EPA can require existing sources
to meet comparable standards, taking "into consideration, among other factors,
the remaining useful life of the existing sourcefs]" involved.  The "other
factors" are nowhere specified but would presumably include the factors
required to be considered in establishing NSPS -- cost, non-air quality health
and environmental impact, and energy requirements.

     The health effects criteria for using standards under Section 111 are
less stringent than those required for regulating hazardous air pollutants
under Section 112, which will be discussed next.  Similarly, Section 111
requires the consideration of costs and technological availability but neither
of these considerations is mentioned in Section 112.
     z"Although EPA must take costs  into account,  formal cost-benefit
analysis is not required.  See Portland Cament Association v. Trair., 512 F.2d
506  (B.C. Cir. 1975), cert, den. 422 U.S.  102.5; Portland Cement Association
v. Ruckelshaus. 436 F.2d 375  (D.C. Cir. 1973), cert, den. 417 U.S.  921
(1974).

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                                   7-12
SECTION 112:  NATIONAL EMISSION STANDARDS "05 HAZARDOUS LIZ POLLUTANTS
(NESKAPs )

    A "hazardous air pollutant" is defined by Sec-ion 112 as "an air pollutant
to which no ambient air quality standard is applicable and which in the
judgment of "he Administrator causes, or contributes to, air pollution which
may reasonably be anticipated to result in an increase in mortality or an
increase in serious irreversible, or incapacitating reversible illness". ' °
The 'underlined terns have, by analogy, the same meaning as in Sections 109  and
111.  Air pollutants qualifying as hazardous are not regulated by  ambient air
quality standards, but instead are subject to the special controls of Section
112.  EPA is directed to list all such pollutants and ta promulgate rules
controlling or disallowing their emissions.

    If such a pollutant is listed, an emissions standard is to be  proposed
within six months after listing the chemical.  This standard must  provide "an
ample margin of safety to protect public health."  National emission standards
may apply to one particular stationary source of a pollutant or to several
categories of sources.  If an emission standard is "not feasible"31 EPA  is
authorized to issue "a design, equipment, work practice, or operational  stan-
dard, or combination thereof which is adequate to protect the public health
with an ample margin of safety".

    The Clean Air Act allots 30 days for public comment after an emission
standard is proposed.  Unless evidence is presented during the public comment
period that indicates an emission standard is unwarranted, final regulations
must be issued within 180 days .
    Section 122 (a) of the CAA  (added  in  1577) directs EPA to study  four
unregulated pollutants:  radioactive  pollutants,12  cadmium, arsenic,  and
polycyclic organic natter.   If EPA determines that  emissions of these pollu-
tants into the anbient  air  "will cause,  or  contribute to, air pollution which
    38GAA Section  112, 42 USC  §7412,  emphasis  added.

    sl"Not  feasible" means  (1)  a hazardous pollutant(s)  "cannot be  emitted
through a conveyance designed  and constructed  to  emit  or capture  such  pollu-
tant, or any  requirement for,  or use  of,  such  a conveyance would  be inconsis-
tent with any federal, state or local law",  or (2)  "the  application of mea-
surement methodology to a particular  class of  sources  is not  practicable  due
to technological or econoaic limitations",  (Clean Air  Act, Section
112(e)(2),  emphasis added).

    I2The tern "radioactive pollutants"  includes  "source material,  special
nuclear material,  and  byproduct material" (42  USC §7422).

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                                   7-13
may reasonably be anticipated to endanger public" health"35 then the Agency
must control or prohibit their emissions under existing regulatory schemes,
namely NAAQS, NESHAPs, and NSPS, or any combination of these actions.  The
regulatory review discusses the listing of radionuclides and arsenic as
hazardous air pollutants.

    Congress specified the four pollutants to be studied and possibly regula-
ted because SPA had failed to establish standards controlling the substances
despite their "proven carcinogenicity".'*  Specific reasons for designating
each pollutant to be studied are discussed below.

         •    Radioactive Pollutants.  Congress was concerned
              about the well known hazards of radioactivity
              including increased risk of cancer, autagenic effects,
              and genetic damage.  Furthermore, the accumulating
              evidence of new emission sources and documented
              effects of low-level ionizing radiation were
              instrumental in Congress'  listing of radioactive
              pollutants for study.55

              The House Committee on Interstate and Foreign Ccmaerca
              recommended that, considering the number of unknown
              sources and uncertain aspects of radioactive wastes
              and waste management, EPA should trace and control
              those increments of radioactive pollutants which can
              be identified."  This meant a shift in
    55CAA Section 122, 42 USC §7422.

    5kHcuse Report No. 95-294, Committee on Interstate and Foreign Ccemerce,
p. 36.

    5STwo major sources were cited as being instrumental in Congress'
addition of radioactive pollutants:  (1) Proceedings of a Congressional Semi-
nar on Low-Level Ionizing Radiation  (November  1976); and (2) Mason Willrich,
(Radioactive Waste Management and Regulation.  U.S. Energy Research and Devel-
opment Administration, MIT Energy Laboratory,  September 1, 1973.

    3 *The primary radioactive sources cited for study were mine tailings,
direct emissions from nuclear powerplants and -nuclear energy research facili-
ties, evaporation of radioactive waste  from water discharges, nuclear weapon
testing, and combustion of coal with a  high radioactivity content.  House
Report, No. 95-294, p. 43.

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                                   •-14
               responsibility from the Nuclear Regulatory Commission
               to "-he Z?A.27

               Cadmium.   Congress cited two studies which
               demonstrated the health risks of occupational and
               nonoccupatonal exposure to cadmium emissions as the
               primary reason for listing cadmium in Section 122 of
               the CAA.   One study, Man, Materials, and Environ-
               ment:   A Report to the National Commission on
               Materials Policy (National Academy of Sciences,
               March 1972), implicated cadmium in the cause of
               cardiovascular disease, respiratory disease, and
               cancer.  Another study by the University of
               Tennessee, Oak Ridge in 1975 showed that cadmium
               concentrates in biological systems with symptoms not
               appearing for 10 to 20 years.  Thus, Congress decided
               that closer study and possible regulation of cadmium
               was necessary.

               Arsenic.   This element has long been known as a
               tox:.c material with cancer potential.  Several
               studies in 1975 and 19763* indicated that people
               living near copper smelters and arsenical pesticide
               plants had high levels of arsenic in their tissues
               and urine.  For these reasons, Congress labeled
               arsenic as a possible candidate for regulation under
               the Clean Air Act and listed it in Section 122.
     3 'The House Committee cited four reasons for changing the primary
responsibility for radioactive air emissions from the Nuclear Regulatory Com-
mission (NRC) to EPA.  First, the Committee felt there was no reason to exempt
certain pollutants from the comprehensive provisions of the Clean Air Act,
Second, NRC's authority to regulate radioactive air pollutants was not broad
enough to protect public health.  NEC regulated air pollutants from nuclear
facilities, but was not authorized to control radioactive air pollutants from
nonnuclear sources, or from certain Defense Department facilities.  Including
radioactive pollutants under the Clean Air Act covered these gaps ia authority.
Third, NRC was primarily concerned with nuclear plant siting- and const ruction,
not environmental considerations.  Congress decided that EPA, with NRC consul-
tation, was the most qualified agency to deal with radioactive sources.
Fourth, the committee hoped to eliminate any duplication of effort by EPA  and
      House Report No. 95-294, p. 43.
     "These studies  included,  (1) NAS-EPA Report, Arsenic, November  1976;
(2) A National Cancer Institute Study of Capper Smelters,  1975;  and  (3)  A
Johns Hopkins University study of neighborhood located near a pesticide  plant.

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                                   7-15
          •    Polyeyclie Organic Matter (POM)..  Testimony by
               several experts at the committee hearings on the
               Clean Air Act Amendments and recommendations from the
               National Air Quality Commission led to the addition
               of POMs to the list of "unregulated pollutants".  The
               testimony and recommendations were based on an EPA
               Report11 and a MAS Report"" which showed POMs to
               be associated with lung and skin cancer in humans and
               animals.

SECTIONS 153. 154, 155 AND 157:   OZONE PROTECTION

     The CAA Ozone Protection provisions are twofold:

         (1)  Sections 153, 154, and 155 direct EPA to conduct
              studies on halocarbon emissions and other
              substances"1 which "affect the ozone in the
              stratosphere" and "may cause or contribute to harmful
              effects on public health or welfare".

         (2)  Section 157 authorizes EPA to promulgate regulations
              to control "any substance, practice, process, or
              activity (or any combination thereof) which . .   . aay
              reasonably be anticipated to affect the stratosphere,
              especially ozone in the stratosphere, if such effect
              in the stratosphere may reasonably be anticipated t£
              endanger public health or welfare," (emphasis added).

    Congress included both sections in the 1977 Amendments to the CAA because
of possible affects of halocarbons and other pollutants on human health.
Halocarbons were used as propellants in aerosol spray cans and refrigerators,
and were postulated to deplete the ozone layer (in the stratosphere) which
screens out the majority of ultraviolet radiation reaching the earth.  The
postulated long-term (10 or 20 years) human health effects from an increase  in
ultraviolet radiation were an increased rate of human skin cancer.is  Con-
gress decided that, although the facts on ozone depletion were not conclusive,
    " Scientific and Technical Assessment Report on Palycvclie Organic
Matter, EPA, March 1975.

    "' Particulate Polyeyclie Organic Matter, HAS, 1972.

    *l Section 153 specifically requires, studies of the effects of halocar-
bons, chlorine, bromine compounds, and aircraft emissions on the stratosphere
(42 USC §7453).

    *2 House Report Mo. 94-575, p. 94.

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                                     iO
the time lag involved dictated that regulation Eight be necessary to safeguard
the public health..k s

    The statute does not mandate immediate regulation, but rather charters
studies to provide information on the need for future action.  If regulation,
is necessary, Section 157(b) instructs EPA to "take into account" the  feasi-
bility and the costs of regulation.  Additionally, medical use products may be
exempted from regulations if there is "no suitable substitute".

    It is important to note that EPA's authority to control halocarbons and
other substances that might deplete the ozone layer does not restrict  EPA's
authority under TCSA, or the authority of FDA, CPSC or other agencies  to  act
under other laws to regulate these substances.1'*

    Section 202:  Motor Vehicle Emissions Standards

    The purpose of Section 202, Motor Vehicle Emission Standards, is to
achieve a level of air quality which meets the National Ambient Air Quality
Standards.  Congress cited data revealing that in 1968, moving sources were
responsible for more than 42 percent of the total emissions of the five major
pollutants.45  In order to meet the National Ambient Air Quality Standards,
Congress determined that significant reductions in the emissions from  automo- -.
biles were necessary.k*  Congress identified carbon monoxide, hydrocarbons,
nitrogen oxides, and particulates as substances contained in automobile emis-
sions and contributing "to poor air quality.  In fact, available evidence
demonstrated that automobiles were emitting 64 percent of the carbon monoxide
and 50 percent of the hydrocarbons in the ambient air.  This led to the
inclusion of emission standards in Section 202 of the Clean Air Act for these
four substances:  Carbon monoxide, hydrocarbons, nitrogen oxides, and
particulates.*r

    Section 2Q2(a)(3)(A) requires EPA to establish emission standards;  for
carbon monoxide. hydrocarbons, and oxides of nitrogen for heavy-duty
vehicles and engines, while Section 202(b)(l) requires emission standards for
these chemicals from light-duty vehicles and engines.  Furthermore, Section
    "3 House Report No. 95-294, pp. 95-99.

    *" House Conference Report, No. 95-564, p.  148.

    "* A Legislative History of the Clean Air Amendments of  1970,  Senate
Consideration of the Clean Air Act, December 1970, p.  126.

    fcs Ibid.

    kr Discussions with the Mobile Sources Division, EPA.

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                                   7-17
202(a)(3)(A)(iii) instructs EPA to prescribe regulations for particulate
matter emissions from "classes or categories of vehicles manufactured, during
and after model year 1981" (42 USC 7521).

     Section 2Q2(a)(l) of the Clean Air Act gives EPA broad authority to  iden-
tify and regulate substances emitted from motor vehicles which pose health  or
welfare risks.  This provision instructs EPA to establish emission standards
for "any air pollutant from any class or classes of new motor vehicles  or new
motor vehicle engines, which . . .  may reasonably be anticipated to endanger
public health or welfare" (emphasis added).  EPA has not employed this  broad
authority, thus far, except with respect to nonexhaust hydrocarbon emissions.

     Technological feasibility and economic costs need not be factors in
setting standards under Section 202(a).  Rather, Congress1 intent was that
standards "should be a function of the degree of control required, not  the
degree of technology available today".4*  Nevertheless, in establishing an
implementation date, EPA must allow time "to permit the development  ... of
the requisite technology, giving appropriate consideration to the cost  of com-
pliance. ..."

     Thus, this section authorized technology-forcing standards*1 while
requiring that cost and technology be considered in setting a data for  compli-
ance.  Consequently, EPA has taken technology and cost into account in  setting
standards under 202(a)."

SECTION 211:  REGULATION 07 -TJELS AM FJEL ADDITIVES "  "

   .  Section 211 of the Clean Air Act authorizes EPA to set requirements  for
fuels and fuel additives to be used in mobile sources.*1  These require-
ments are twofold:  First, EPA may require any fuel or fuel additive to be
registered with EPA prior to selling, offering for sale or introducing  into
commerce that substance.*1  Second, EPA "may control or prohibit the manu-
facture, introduction into commerce, offering for sale or sale" o-f fuels  and
     "'Senate Report No. 1196, 91st Cong., 2d Sess., p. 24  (1970).

     %1See Senate Report No. 127, 95th Cong., 1st Sess., p.  73  (1977)  ("The
Secretary is expected to press for the development  and application  of  improved
technology rather than be limited by that which exists. )

      "See, e.g., 43 T3. 37970  (1978) (evaporative emissions  from  light-duty
trucks).

      5;Engine oil additives cannot be regulated under  Section  211.   Lubri-
zol Cor?, v. EPA. 562 ?.2d 807 (D.C. Cir.,  1977).

      523y January 1977, 1,920  fuel additives, 311 .gasolines, and  250 diasal
fuels had been registered.  H.R. Rep. No. 294, 95th Cong.,  1st. Sess.  207.

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                                   7-18
additives if their emission products (1; cause, or contribute to, "air pollu-
tion which may reasonably be anticipated to endanger the public health or
welfare," or (2) "will impair to a significant degree the performance of any
emission control device or system".

     When a fuel or additive is registered, EPA may require manufacturers to
submit various information including the effects of emission products on pub-
lic health and public welfare, as well as the impact on the performance of
emission control devices/systems (to the extent such information is known to
the additive manufacturer).  EPA also may require manufacturers "to conduct
tests to determine potential public health effects of such fuel or additive
(including, but not limited to, carcinogenic, teratogenic, or mutagenic
effects)".  In this way, EPA can monitor the composition of fuels and fuel
additives to guard against the introduction of fuels or additives which could
result in exhaust products damaging to public health, public welfare, and/or
emission control devices.

     Congress authorised EPA to regulate fuels and fuel additives because of
concern about the direct and indirect hazards posed by fuel composition.  The
emission products of fuels and additives might pass through vehicles and
directly endanger the public.  Also, fuel additives might adversely affect
devices for controlling other automotive emissions.53  Thus, Section 211(c)
authorizes EPA action on two alternative grounds.  Exhibit 7-2 schematically
illustrates the statutory criteria for regulating fuels and fuel additives.
The two basic criteria are included, (1) endangering public health, and  (2)
impairing the performance of an emission control system.  In the exhibit, the
letters (e.g., (a), (b),  .. . .) indicate the factors EPA must consider in
order to base regulations on the numbered criterion situated above.

     Before regulations are prescribed based on the first criterion, EPA is
required by Section 211(c)(2)(A) to consider "all relevant medical and scien-
tific evidence available, including consideration of other technologically or
economically feasible means of achieving emission standards under Section
202".5*

     To regulate fuels  and fuel additives because they impair the performance
of emission control devices, EPA must consider "available scientific .and eco-
nomic data, including a. cost-benefit analysis comparing emission control
devices or systems".55
      1'Senate Report No.  1196, 91st Cong., 2d Sess., pp.  33-34  (1970).

      5*42 USC §7545(c)(2)(A).

      "Section  211(c)(2)(B); 42 USC §7545  (c)(2)(B).

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                                    7-19
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                                   7-20
     In order to regulate a fuel or additive based on "either  criterion,  EPA
must publish evidence that prohibiting the use of the fuel or  additive will
not result in substitutions of other fuels or additives which  prove harmful to
public health "to the same or greater degree" than the use of  the prohibited
substance.s*

     Section 211(f) specifically limits the allowable concentration of man-
ganese to .0625 grams for gallon and outlaws as well all other new fuels or
additives which are not substantially similar to those already utilized.
Likewise, 211(f) bans the increase in concentrations of existing additives.
This section was added in 1977 because the Senate Committee was disturbed by
reports that an organo-manganese additive called MMT impaired  the perforaaace
of emission control devices for hydrocabons.*7

     Section 211 regulations have resulted in much litigation  including  three
key cas es:

          (1)  NRDC v. Train which established that fuel controls
              were intended by Congress as a means for attaining
              primary air quality standards rather than as an
              alternative to promulgating such standards."

          (2)  Ethyl Corp. v. EPA which interpreted the risk of harm
              standard ' will endanger" as precautionary in nature
              and not requiring proof of actual harm before
              regulating.  This case held that §211 authorizes the
              EPA to assess risks of harm and, where risk is  found
              to be significant, to act to prevent haro from
              happening.*'

          (3)  Amoco Oil v. EPA which upheld regulations requiring
              lllead-free" fuel to protect eaisson control systems.
              The opinion noted that the statute does not require
              that compliance be feasible or economically
              reasonable, but it does not preclude consideration of
              these factors.*'
    *« CAA Section 211(c)(2)(C); 42 USC §7545(c)(2)(B).

    S7 Senate Report No. 127, 95th Cong., 1st Sess., p. 50  (1977).

    *' NSDC v. Train, 545 F.2d  320 (2d Cir., 1976).

    13 Ethyl Cora, v. EPA. 506  F.2d 1321  QD.C. Cir. 1975),  rev'd. on reh.
en bane 541 F.2d  1 (D.C. Cir. 1976), cert, den.  426 US 941  (1976).

    st Amoco Oil  v. EPA. 501 F.2d 722,741-3  (D.C. Cir., 1974).

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                                   7-21
    These cases were decided before the 1977 Amendments to the Clean Air Act.
The 1977 Amendments endorsed the Ethyl approach far the entire CAA as
discussed elsewhere.S1

SECTION 231:  AI3C3AFT SCISSIONS

    The statutory instructions for regulating aircraft emissions, Section  231,
are identical to those for motor vehicle emissions.  Section 231(a)(2)  autho-
rizes EPA to issue an aircraft emission standard for "any air pollutant from
any class or classes of aircraft or aircraft engines which . . . causes, or
contributes to, air pollution which may reasonably be anticipated to endanger
public health or welfare" (42 USC 7571).  Furthermore, the purpose of aircraft
emission standards is the same as the purpose for actor vehicle  emission stan-
dards:  To achieve a level of air quality which meets NAAQS.  Unlike the zotor
vehicle emission section of the Clean Air Act, Section 231 does  not specify
the substances to be regulated.'1  Section 231 also directs EPA  to study
aircraft emissions to determine the magnitude of the pollutant problem  ar.d the
technological feasibility of controlling aircraft emissions.  Regulations  are
to take effect after a period of time needed to develop the appropriate tech-
nology and giving appropriate consideration to the cost of compliance.


OVE3VTSV OF STATUTORY ACTHORITY

    Based on the foregoing review of the statutory provisions, legislative
history," and caselaw, it is possible to draw some conclusions about EPA's
authority to designate and regulate under the Clean Air Act.  Exhibit 7-3
displays the key statutory criteria and terms.  Tnis Exhibit reveals overlaps
and complementarities among the provisions as well as the bases  for
regulation.  Some provisions are source-specific (e.g., new source standards,
mobile source standards),•others are more general.  The role of  economics  and
technological feasibility varies too.  Most provisions are oriented toward
achieving the NAAQS criteria pollutants but others are broader in scope.   How
the agency has used its CAA authority is discussed in the regulatory review.
The following sections consider:  (1) specificity in designating chemical
    * iThe Ethyl litigation focused exclusively on the question whether  any
regulation of fuel lead was justified by health considerations but did  not
address the specific ceiling on  lead content chosen nor how this decision was
reached.

    *2The same chemicals are regulated by aircraft emission standards as are
regulated by motor vehicle emission standards with one exception.  Hydro-
carbons, carbon monoxide, and oxides of nitrogen are common to both  standards
while particulate matter is regulated only under Section  2Q2, and sizcka is
regulated only under Section 231.

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                                   7-24
substances; (2) designation criteria:  harm, causality, and certainty; and  (3)
regulatory flexibility under the CAA.

Specificity in Designating Chemical Substances

    A key issue in the regulation of toxic substances relates to the speci-
ficity with which chemical substances must be designated for regulation.  The
Clean Air Act seems to authorize the generic designation of related substances
and EPA's regulations are written accordingly.  The CAA defines "air pollutant"
la as expansive manner as:

         any air pollution agent or combination of such agents,
         including any physical, chemical, biological, radioactive
         . .  .  substance or matter which is emitted into or
         otherwise enters the ambient air."1

     Thus, the ambient: air standard for particulata matter includes any  sub-
stance that can b« detected in. that form.  Although evidence is mounting that
the most hazardous particulates are the smaller "respirabla" ones, this
relates to the size of the particles and not their chemical composition.

     The definition of "air pollutant" underlies the MAAQS as well as  the sta-
tutory authority for New Source Performance Standards and for mobile source
standards.  Hazardous air pollutants are simply "air pollutants" which have
certain hazardous health effects (CAA Section 112).  Throughout the Clean Air
Act, Congress has relied on "generic" categories of pollutants and has,  for
example, directed EPA to study the desirability of regulating "radioactive
pollutants" and "polycyclic organic matter" (CAA Section 122).  Likewise,
Congress requires the EPA to submit progress reports with respect to the
control of sources of "aalocarbon emissions" which are defined as:

         the chemical compounds CFC1_ and CF.C12 and such
         other halogenated compounds as  ... may  reasonably be
         anticipated to contribute to reductions in the
         concentration of ozone in the stratosphere.'4

    Only two legal cases have ruled on EPA's authority to regulate related
substances under the CAA.  In the case of airborne lead, EPA's inclusion of
alleged insoluble and nonrespirable particles in the ambient air standards  was
upheld in  court because there was some evidence of health effects from such
particles.*5   In Ford Motor Company v. EPA, the EPA's  regulation of
     •* CAA Section 302, 42 USC  §7602(g).

     •* CAA Section 132, 42 USC  §7452.

     11
       Lead  Industries Assoc.,  Inc. v. EPA.  14 ERC  1680,  	  F.2d
 (D.C. Cir. 1980), cart.  den.  	 U.S. 	  (1980).

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                                   7-25
automotive hydrocarbon emissions was challenged because the standard applied
to both methane and nonmethane hydrocarbons.  Methane is a nonreactive
hydrocarbon which does not contribute to air pollution and EPA's NAAQS are
specified in terms of nonnmthane hydrocarbons.''  Ford Motor Company argued
that Section 202 does not permit EPA to control methane emissions because they
do not "cause or contribute to air pollution which may reasonably be
anticipated to endanger public health or welfare".  The District of Columbia
Court of Appeals upheld the EPA standard finding that (1) Congress used the
term "hydrocarbons," (2) EPA's total hydrocarbon standard results in less
emissions of harmful nonmethane hydrocarbons, (3) EPA's original pre-1970
standard was for total hydrocarbons and Congress ratified this approach in
1970 and 1977 implicitly.  Finally, the Court pointed out that EPA need not
regulate hydrocarbons according to the criteria of Section 202(a) but can rely
on 202(b) instead, thus eliminating the need to demonstrate health effects.

    Designation Criteria:  Causality, and Certainty of Harm

    In the 1977 Amendments to the Clean Air Act, Congress paid particular
attention to the criteria required to regulate a substance under the CAA.  The
Congress moved to unify the disparate requirements of the 1970 Act by adopting
a standardized basis for rulemaking under Sections 108 (criteria for national
ambient air quality standards), 111 (new source standards of performance), 112
(hazardous emission standards, although the nature of the risk, oust be more
serious), 202 (new motor vehicle standards), 211 (fuels and fuel additives,
and 231 (aircraft emissions standards).  EPA may now regulate a pollutant's
emissions

         which in the judgment of the [EPA] Administrator cause or
         contribute to air pollution which may reasonably be
         anticipated to endanger public health or welfare.

    The Congress had several goals in mind in adopting this formulation.  The
term "in the judgment of the [EPA] Administrator" was intended to modify both
the "cause or contribute to'1 phrase and the "may reasonably be anticipated"
phrase in order to emphasize the "necessarily judgmental element in the task
of predicting future health risks of present action and to confer  . . . the
requisite authority to exercise such judgment".  In order to emphasize "the
precautionary or preventive purpose" of the Clean Air Act and the EPA's "duty
to assess risks rather than wait for proof of actual harm" Congress retained
from the 1970 Act the concept of endangerment to health and added the words
"may reasonably be anticipated".  3y using the words "cause or contribute to
air pollution," Congress intended the EPA to consider "all sources of the
     **See 44 FR 20086  (1979)  (methane  is photochemically unreactive  and does
not  contribute to the  formation of smog).  Ford Motor Company v. EPA.  604
F.2d 685 (B.C. Cir., 1979)  (per curjam).

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                                   7-26
contaminant which contribute to air pollution and to consider all sources of
exposure to the contaminant--food, water, air, etc.--in determining health
risk".'7  This laat point needs some clarification; in the case of lead,

         While [sic] the incremental effect of lead emissions on the
         total body lead burden is of no practical value in
         determining whether health is endangered, (1) the
         contribution must be significant before regulation is •
         proper and (2) the incremental effect is of value in
         deciding whether the lead exposure problem can fruitfully
         be attacked through control of lead additives."

    Congress was motivated to clarify the EPA's regulatory authority followLng
the decisions in the Ethyl case."  Among the issues raised in that case
and answered in the 1977 Amendments are:

         (1)  The EPA may act to prevent harm before it occurs and
              need not find that actual harm has already occurred
              before it regulates.

         (2)  EPA's duty includes the assessment of risks and not
              just findings of past fact.

         (3)  EPA is not required to prove endangennent is caused by    .
              emissions of a pollutant from a single class of
              sources without respect to other sources of the
              pollutant; the EPA should consider the cumulative risk
              to public health from multiple sources of the
              pollutant, including total body burden resulting from
              all exposures.

         (4)  The same standard of proof should apply to regulation
              of mobile sources, fuels and additives, and stationary
              souces of emissions.

         (5)  Protection of public health should extend to
              susceptible individuals and not be limited to
              protection only of healthy adults.
    *7 Legislative History of the Clean Air Act Amendments of  1977. p.  1129.

    " Ethyl Corp. v. EPA 541 F.2d l,31n.62, citing 39 FR 33734.

    " Ethyl Com, v. EPA. 506 F.2d 1321  (B.C. Cir. 1976), cert, den. 426
U.S. 941.  The Ethyl litigation concerned Section 211 regulation of additivis
but applied, through dicta, to the entire Clean Air Act.

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                                   7-27
         (6)  The court's standard of review should be whether the
              EPA has reached reasonable conclusions which are
              rationally justified.7"

    Practical constraints led the Congress to endorse and adopt these posi-
tions.  Moreover, Congress felt it was moving in a direction consistent with
most judicial interpretations of the CAA.71  In light of the problems
involved in regulating environmental contaminants, Congress clearly authorized
the exercise of reasoned judgment and discretion in finding a middle road.

    Summary of Regulatory Alternatives

    The Clean Air Act presents the EPA with several statutory provisions which
can be used to control air pollutants.  Nevertheless, these provisions do sot
necessarily provide alternative remedies for regulating specific pollutants.
One court has pointed out that "there is no language anywhere in the statute
which indicates that the EPA has discretion to choose among the remedies"
which the CAA provides.72  The Second Circuit Court of Appeals' likewise
rejected EPA's argument that it could choose to control lead (or other
pollutants) under Section 211 instead of listing it under Section 108 for the
development of air quality standards.71  The Court reviewed the legislative
history of the 1970 CAA Amendments and concluded that both the Section 211
fuel controls and the Section 111 new source performance standards were inten-
ded by Congress as means for attaining ambient air quality standards rather
than as alternatives to promulgating such standards.7"

    Thus, the existing caselaw suggests that the emission source controls
authorized by §§109, 111, 202, 211, and 231 are supplements to air quality
standards, not alternatives.  Hazardous air pollutants are distinct because no
air quality standard is supposed to be applicable to such pollutants by the
express statutory language of Section 112; however, NESHAPs may be established
for both new and existing sources, although not for mobile sources.
     71
       Legislative History, pp.  1126-28.
     71 Ibid.. p.  1129, citing South Terminal  Con;,  v. EPA. 504 F.2d  646
 (1st Cir.,  1974); Amoco Oil v. EPA. 501 F.2d  722  (D.C. Cir.,  1974);  Texas  v.
 EPA. 499 F.2d 289 (5th Cir., 1974); Portland  Cement Assoc. v. Ruekelshaus.
 456 F.2d 375 (D.C. Cir.,  1973).

     71 NRDC v. Train. 411 F.Supp.  864,368  (S.D.N.Y.,'1976).

     71 NROC v. Train. 545 F.2d 320,324  (2d Cir.,  1976).

     7lk Ibid, at 325,326,327.

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                                   7-28
    This state of tfftirs wai altered by th« 197? Amendments to the Clean Air
Act for certain specifically designated substances:  radioactive pollutants,
cadmium, arsenic, and polycyclic matter.  Section 122 authorizes EPA to  regu-
late emissions under the NAAQS, NSPS, or NESHAPs programs, or any combination
of these actions.  This does not seem, however, to overrule the holdings
discussed above or the express language of Section 112.

    For purposes of this review, a key issue is the regulation of substances
under the NAAQS, NSPS, or NESHAPs programs.  Exhibit 7-4 summarizes the
differences between regulating chemicals under Section 109, Section 111, and
Section 112 of the Clean Air Act.

    First, the purposes are different.  NAAQS's purpose is to provide  a.
minimum standard for ambient air quality across the nation.  Specific
emission limits for sources must be developed by states and need not be
uniform.  NSPS and NESHAPs provide uniform emission ^standards for specific
facilities that emit pollutants determined to be hazardous.

    Second, the focus of NAAQS is on chemicals with a broad national impact.
NAAQS is applicable to chemicals emitted from widely distributed stationary
and mobile sources, and to chemicals generally oresant in  the ambient  air  In
all areas of the nation.  The expressed legislative focus  of Section 112 is
on a specific class of chemical pollutants believed to be  highly hazard-
ous."71  For example, because vinyl chloride emissions are a localized
problem, they are regulated under Section  112, not Section 109.7S  The focus
of Section 111 'is on categories of sources and allows EPA  tc control a varifity
of pollutants emitted by specific industries.

    Third, the factors to be considered and the  level of protection afforded
differs for each provision.  Neither cost  nor technology is to be considered
in issuing NAAQS, both are to be considered as the basis for NSPS, and both
have been considered in, issuing NESHAPs, although  Section  112 is silent  about
the role of these considerations.  Furthermore,  both Sections 109 and  112
require that standards provide a margin of safety; no similar requirement  is
included in Section 111.

    Fourth, the National Ambient Air Quality Standards/State Implementation
Plan process does not provide the expedited means  of control that Section 111
or 112  regulation does.  Under the NAAQS program,  each state has discretion in
developing a set of emission  limits  for stationary sources and  also  is given  a
     7lTaken  from comments by congresspersons  during  House  consideration of
the  Conference Committee Report on  the  NESHAP section.   A  Legislative History
of the Clean Air Amendments of  1970. p.  116.

     7«See 40 FR 59534  (December 24,  1975).

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                                   7-30
lengthy time period to meet NAAQS standards.  Theoretically, hazardous  air
pollutants may be regulated as Section 109 pollutants such as volatile  organic
compounds and particulates•  However, EPA does not place special emphasis on
the control of hazardous pollutants when approving State plans to implement
Section 109.  EPA approval of state implementation plans adds time to the
regulatory process, too.  If an air pollutant is toxic or carcinogenic,
regulation under NSPS or NZSH&PS may be more appropriate than regulation under
NAAQS.  Under both Section 111 and Section 112, the EPA has the authority to
establish and enforce emission standards for both new and existing sources.
Thus, Section 112 offers a faster regulatory process than Section 109.  This
time factor could be important in some cases for the protection of public
health.  Section 111 provides an expedited process, but only for new sources;
control of existing sources under lll(d) must be implemented through the SI?
process.

    Finally, regulations under Section 109 or 111 are applicable to pollutants
which endanger public health and public welfare, while regulations under
Section 112 are applicable only to pollutants which seriously endanger  public
health.

Two Examples

    Mercury v. Lead.  Mercury and lead share many characteristics.  These
common characteristics include:

         •    adverse health effects result from exposure;

         •    multiple sources of exposure exist (air, drinking
              water, food);

         •    direct (inhalation) and indirect  (ingestion) human
              exposure occurs;
         •    both chemicals accumulate  in the human body;

         •    "safe" ambient concentration levels have been
              determined by EPA.

    To be listed under Sections  108  and  109, the presence of the air  pollutant
in the ambient air must result from  "numerous or diverse mobile or  stationary
sources."77  Lead is emitted to  the  atmosphere by vehicles burning  leaded
fuel and by many stationary sources;  thus, lead meets the legislative
requirements of Sections 108 and 109.  Sections 111 and  112 apply  to
     77Clean Air Act.  Section  108(a)(1)(3).  Air Quality  Criteria  and
Control Techniques.  Emphasis  added.

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                                   7-31
stationary sources only, so regulation for air lead is more appropriate under
NAAQS.

    At first glaaca, mercury seems to fulfill the legislative requirements  of
Sections 108 and 109.  Humans are exposed to multiple sources, i.e.,  airborne,
waterborae, and foodborae, of mercury.  Unlike lead, there ars only  tvo r.a:or
sources of mercury emissions (mercury ore processing facilities and  mercury
cell chlor-aikali plants) which have been found to emit mercury in a manner
that could cause the ambient concentration to exceed the "safe" level.  Sec-
tion 111 or 112 provides a more appropriate means of controlling the mercury
emissions from these two sources, than the Section 108 and 109 comprehensive
regulation intended  for "numerous or diverse" stationary and mobile  sources.

    At the time the National Emission Standard for Mercury was promulgated,
EPA did not have sufficient data to assess the indirect effects of mercury
emissions.7*  The effect of mercury emissions into the atmosphere on the
mercury content in water, food, and non-food materials is uncertain.  Ones  the
indirect effects of mercury emissions are known, more comprehensive  control of
mercury emissions into the air, as is found in the National Ambiant  Air
Quality Standards, may be considered by EPA.71  Whether EPA has the  legal
authority to issue NAAQS for Section 112 substances like mercury is  unclear.

    Benzene and Parehlorethylene.  The Preamble to the National Emission
Standard for Benzene Emissions from Maleic Anhydride Plants reports  the
rationale for regulating benzene emissions under the authority of Section  112
of the Clean Air Act rather than under Sections 108 and 109.*3  EPA
considered regulating benzene only under the ozone NAAQS applicable  to
photochemical oxidants.  According to EPA, State Implementation Plans for
reducing volatile organic compounds (VOCs) from maleic anhydride plants csuid
reduce benzene emissions.  However, EPA rejected reliance on Sections 108  and
109 for control of benzene emissions for these reasons:

         (1)  A particular State may not need to control maleic
              anhydride plants to meet the National Ambient Air
              Quality Standard, and

         (2)  A particular State may not need to control benzene
              emissions to the same extent as may be appropriate for
              benzene in light of its hazardous nature.':
    71 Preamble to National Emission Standard for Mercury.  38 73.  3825
 (April 6, 1973).
     7' Ibid.

     i a
       45 FR 25660  (April 13, 1980).

    11 45 FR 26662  (April 18, 1980).

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    This reasoning is somewhat misleading because although benzene  is  a  V03  it
is not photochemically reactive  (See 4.2 FS 2S214, July 8, 1977)'.  However,
the same reasoning applies to perchlcroethylene which ^s  a reactive 70C  and
which, is to be controlled under  a proposed NS?S for both  new  and  existing
sources involved in organic solvent cleaning  (i.e., degreasing).
rerchlcroethylene could be regelated under either Section 111 or  Section 112,
and, because of its effects on the stratospheric ozone layer, even  Section  157
could be used as statutory authority.  Thus,  so long as the applicable
statutory criteria are satisfied, EPA may choose among alternative  approaches
to regulating air pollutants.

    Conclusion.  Except for the  statutory requirements, there are no rigid
rules for -determining which section of the Clean Air Act  would  be applied to a
particular chemical.  I?A has approached the  task on a chemical-by-chemical
basis.  The Agency has examined  the characteristics of each chemical
considered for regulation to decide which regulatory treatment  is most
appropriate for the particular chemical.  As  a result of  this
chemical-by-chemical approach, there are opportunities for inconsistent
applications of the various sections of the Clean Air Act.  It  appears that
EPA, thus far, has sufficiently  justified the choice of Clear, Air Act  sections
atsoiied.

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                                   7-33
                      CLEAN AIR ACT--REGULATORY REVIEW'
    The following Tabulations promulgated or proposed under the authority of
the Clean Air Act ara reviewed:

         •    40 CTR 5Q--National Primary and Secondary Ambient
              Air Quality Standards

         •    40 CFR 60—Standards of Performance for Hew
              Stationary Sources

         •    40 CFR 61--National Emission Standards for Hazardous
              Air Pollutants

         •    40 C7R 36—Control of Air Pollution from New Motor
              Vehicles and New Motor' Vehicle Engines

         •    40 CFR 87--Control of Air Pollution from Aircraft
              and Aircraft Engines

         •    40 CTR 79—Registration of Fuels and Fuel Additives

         •    40 CFR SO—Regulation of Fuels and Fuel Additives.

The regulatory reviews focus on the criteria used by EPA to designate air
pollutants and the criteria relied on to establish standards for them.

    There are similarities among the regulations concerning the criteria used
by EPA such as the use of adverse health effects to justify regulation.  How-
ever, there also are differences in. the manner designated pollutants are
treated.  For example, EPA is required by the Clean Air Act to establish
national ambient air quality standards with "an adequate margin of safety to
protect public health".  Because neither Congress nor EPA has defined the term
"adequate margin of safety" explicitly, the Agency has considerable flexibil-
ity in determining'what constitutes "an adequate margin of safety".

    EPA's flexibility expends to the application of other Clean Air Act pro-
visions to chemicals.  In some instances EPA has interpretted the statutory
mandate, "to protect public health," to mean the most sensitive population
must be safeguarded.  In contrast, the Agency has not identified, the sensitive
population in other rulemaking procedures.  Furthermore, EPA has considered
synergistic effects of chemicals only when establishing some standards.
Similarly, assumptions about the extent of human exposure, e.g., additive
exposure, have been made in several, but not all cases.  Finally, the types of
tests and evidence relied on to conclude that a particular chemical poses a
risk to public health vary from one standard setting procedure to another.

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                                   7-34
    The most salient difference among the regulations is the consideration of
economic and/or technological feasibility.  In some cases EPA is required to
consider economic and technological feasibility, e.g. new source performance
standards, whereas in other cases standards must be based exclusively on
health-related effects, e.g., National Ambient Air Quality Standards.  Thus,
the role of economic and technical feasibility considerations is examined for
each regulatory program reviewed.

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                                   7-35
                  NATIONAL AMBIENT AIR QUALITY STANDARDS--
                              REGULATORY REVIEW
INTRODUCTION

    The National Ambient Air Quality Standards (NAAQS), Sections 108, 109, and
110 of the Clean Air Act, provide one means of controlling hazardous air
pollutants.  This paper summarizes the regulations promulgated under the
authority of those sections:  40 CFR 50--National Primary and Secondary
Ambient Air Quality Standards.  The focus is on the criteria used by EPA to
designate chemical substances for which standards are issued; in addition, the
factors considered by EPA when establishing ambient air quality standards are
examined.

OVERVIEW

    To date, EPA has listed seven chemicals under Section 108 of the Clean Air
Act.  The chemicals and their Code of Federal Regulations citations are:

         (1)  Sulfur Oxides (40 CTR 50.4, 50.5)
         (2)  Particulate Matter (40 CFR 50.6, 50.7)
         (3)  Carbon Monoxide (40 CFR 50.8)
         (4)  Ozone (40 CFR 50.9)
         (5)  Hydrocarbons  (40 CFR 50.10)
         (6)  Nitrogen Dioxide (40 CFR 50.11)
         (7)  Lead (40 CFR 50.12)

    Air quality criteria documents for these seven listed chemicals have been
issued.  The Chemical-By-Chemical Analysis section of this paper summarizes
each Air Quality Criteria Document.  The emphasis of the summary is on
identifying the factors which were instrumental in the establishment of
ambient air quality standards.  In addition, the promulgated national primary
and secondary standards for the seven chemicals are reviewed.

    Exhibit 7-5 presents a chronological review of the regulatory and judicial
actions related to Sections 108 and 109 of the Clean Air Act.  The National
Air Pollution Control Administration, Department of Health, Education, and
Welfare, was responsible for controlling air pollutants prior to the
establishment of SPA.  In fact, the original air quality criteria documents
for sulfur oxides, particulars natter, carbon monoxide, photochemical
cxidants, and hydrocarbons were published by the National Air Pollution
Control Administration.

    Exhibit 7-6 summarizes the criteria used by EPA to establish primary and
secondary ambient air standards.  The criteria for listing chemicals under
Section  108 are excluded from Exhibit 7-6, because all seven chemicals were
listed for the same reasons:  (1) they endanger public health and welfare, and
(2) they are emitted from numerous or diverse sources.

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                                 EXHIBIT 7-5

                           REGULATORY CHRONOLOGY:
                   NATIONAL AMBIENT AIR QUALITY STANDARDS
     Dare

February 11, 1969




Marsh 19, 1970



January 30, 1971
     Regulator^ Action
Federal Reeister Citation
National Air Pollution Control
Administration (NAPCA) Issued Air
Quality Criteria for Particulate
Matter and Sulfur Oxides.

NAPCA Issued Air Quality Criteria
for Carbon Monoxide, Photochemical
Oxidants and Hydrocarbons.

(1) Nitrogen Oxides Listed
(2) EPA issued "Air Quality
    Criteria for Nitrogen Oxides"
(3) EPA proposed Primary and
    Secondary Standards for
    Sulfur Oxides, Particulate
    Matter, Carbon Monoxide,
    Photochemial Oxidants,
    Hydrocarbons, and Nitrogen Oxide.

NAAQS promulgated for Sulfur
Oxides, Particulate Matter, Carbon
Monoxide, Photochemical Oxidants,
Hydrocarbons and Nitrogen Oxides
(40 CFR Part 410)

40 CFR Part 410 regulations
republished as 40 CFR Part 50:
National Primary and Secondary
Anbient Air Quality Standards
September 14,  1973   (1) Revocation of Annual Secondary
                        Sulfur Oxide Standard
                     (2) Revision of "Air Quality
                        Criteria for Sulfur Oxides"
April 30, 1971
November 25,  1971
April 8,  1976

April 20,  1977
Lead Listed

EPA reviewing, updating, and
revising Air Quality Criteria
Documents  for Photochemical
Oxidants and Hydrocarbons
          34 FR 1956
          33 FR 4768
          36 FR  1515
                                                             36 FR  1502
          36 FR 8186
          36 FR  22384
                                         38 FR  25678
          41 FR

          42 FR
14921

20493

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                                   7-37
     Date

December 14, 1977



December 16, 1977




June 22, 1978
October 5, 1978

December 1, 1978



December 12, 1978



February 8, 1979


July 11, 1979



October 2, 1979



January 16, 1980
              EXHIBIT 7-5
              (continued)

        REGULATORY CHRONOLOGY:
NATIONAL AMBIENT AIR QUALITY STANDARDS

      Regulatory Action         Federal Register Citation

 (1) EPA issued "Air Quality              42 FR 63076
     Criteria for Lead"
 (2) NAAQS proposed for Lead

 External Review Draft of "Air            42 FR 63460
 Quality Criteria for Shore-Term
 Exposures to Nitrogen Oxides"
 available

 (1) Revised "Air Quality Criteria        43 FR 26962
     for Ozone and Other Photochemical
     Oxidants"
 (2) Changed the Chemical Designation
     of NAAQS from Photochemical
     Oxidants to Ozone

 NAAQS promulgated for Lead               43 FR 46246

 EPA reviewing, updating, and             43 FR 562.30
 revising "Air Quality Criteria
 for Carbon Monoxide"

 External Review Draft of Air             43 FR 58117
 Quality Criteria Document for
 Oxides of Nitrogen Available

 NAAQS revised for Photochemical          44 FR 8202
 Oxidants

 Second External Review Draft of Air      44 FR 40559
 Quality Criteria Document for Oxides
 of Nitrogen Available

 EPA reviewing, updating, and             44 FR 56730
 revising the Criteria Document for
 Particulate Matter and Sulfur Oxides

 Final Revision of "Air Quality           45 FR 3107
 Criteria for Ozone and Other
 Photochemical Oxidants" issued*

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                                   •-38
                                 EXHIBIT "-5
                                 (continued)

                           REGULATORY CHRONOLOGY:
                   NATIONAL AMBIENT AIR QUALITY STANDARDS

     Date                Regulatory Action         Federal Register Citation

March 10, 1980      External Review Draft of "Facts          45 FR 15262
                    and Issues Associated with the Need
                    for a Hydrocarbon Criteria Document"
                    Available

April 11, 1980      First External Review Draft of           45 FR 24913
                    "Air Quality Criteria for Parti-
                    culate Matter and Sulfur Oxides"
                    Available

June 18, 1980       EPA Denial of Petition for Reconsi-      45 FR 411.11
                    deration of Revision of Lead NAAQS

June 27, 1930       Lead NAAQS upheld by D.C. Circuit
                    Court of Appeals

August 18, 1980     (1) Revised NAAQS Proposed for           45 FR 55066
                        Carbon Monoxide
                    (2) Revised "Air Quality Criteria
                        for Carbon Monoxide" issued

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                                                7-39
                                             EXHIBIT  7-6
       Hatiana.1  Aabiont Air
                                 V/ Standards  laplamroeation of  aaalth and Walfara Sfiects Crilana
      Primary  Standards
         Health Effaces
          Critaria
                                 Sulfur   Pareicolata    Carbon
                                 Oxidas      Maerar     Monoxid*    Oaona    avdrocarbons
                                                                                           3ioxide    ^aa
     Ipidaniolojisal seodia* of
       Baaltti SISacsa

     - 5yn«r7is-eic Siiaeza
     - ^ong-T«rai
     - Shore Tarm

     liooratory Cbs«rva.cioos
       of 3«allh 2£fa
3.   Isdtnct a»aliii Effaces

4.   Do»«-T««pon»a Ralation-
       »hip»

5.   Idaneiflad Sanslti.?*
7.

3.
     7 j horanory Aoiaal Stadias

     Sorr-air Sxpoauraa

     AdiUtiiva Sxpoaura
       (Cuaulau.7* Effaces)
        Sacocdar/ Standarda
      Adv«rs« w«liar« Sffacrs    Sulf-^r   ?ar:iculaea    Carbon                          Hi-r=qen
             Csitarla	Cacidas	aariar	Monoxida   Qsona   aydraearbona   Siax^jg
1.   Sffaces on Visibility

:.   Sffaces on Ma-earials

3.   Effaces on Vagatation

4.   Sffaetsi on Public Cancan

S.   Effaces on Cliaata

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                                   7-40
    To set primary standards, EPA relied primarily on direct health effects cf
chemicals.  Only in one case, hydrocarbons, were the primary standards based
on indirect health effects.  Epideicioiogical  (long-term and short-tars;),
laboratory, and laboratory animal studies were the types of data considered by
EPA in assessing health effects.  The sensitive population was identified  in
most cases (except for particulare matter and hydrocarbons), and the primary
standards were established according to the direct health effects on these
particularly sensitive groups.  Precise dose-response relationships were
available only for carbon monoxide and lead,  and served as guides when setting
their primary standards.  The estimation of allowable air increment of lead
was important in deciding that chemical's primary NAAQS, because significant
amounts cf lead pollutants result from non-air sources.  The fact that lead
accumulates in the blood stream, resulting in additive exposure, was a key
factor in determining the primary standard for lead.

    To establish secondary standards, EPA considered only adverse welfare
effects.  One welfare effect considered was the contribution of air pollutants
to visibility impairment.  The importance of  the effect on visibility is that
as visual ranges decrease, operations at airports are increasingly delayed.
The effects of air pollutants on materials were instrumental in setting
.secondary NAQQS.  In particular, building material damage, textile damage, and
paint damage were the types of effects on materials cited by the Agency when
setting secondary standards.  Effects on vegetation served as another criteria
for the determination of secondary NAAQS.  EPA examined visible and subtle
effects on vegetation to assess welfare effects.  Finally, a few secondary
standards were based on the effects of chemicals on climate and public concern.

    Exhibit 7-6 clearly illustrates that all  secondary NAAQS were not based on
the same factors.  It is important to note that Exhibit 7-4. does no_r reflect
the welfare effects cited in each air quality criteria document; rather, the
Exhibit identifies rnose welfare effects actually considered by EPA when
establishing secondary standards.  The Chemical-by-Chemical Analysis section
presents more extensive analyses of the standards and the criteria on which
they are based.

    Exhibit 7-7 summarizes the National Primary and Secondary Ambient Air
Quality Standards.  The seven pollutants for  which standards have been
established are listed in the "Pollutant" column.  Sulfur dioxide and
particulate matter are the only chemicals for which separate primary and
secondary standards have been promulgated.  It is clear from examining the
"Averaging Time" column that short-term and long-term standards have been
promulgated for some chemicals, whereas for others only one type has been
issued.  The frequency parameters are not consistent among chemicals.  They
vary from an annual geometric mean to an annual maximum not to be exceeded
more than once per year. .Exhibit 7-7 also includes the standards expressed in
units of micrograms per cubic meter and parts per million (if appropriate).

    The most salient characteristic of listing chemical substances under
Section 108 and issuing NAAQS under Section 109 of the Clean Air Act is the

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                                             7-41
                                          EXHIBIT 7-7

                               ry:  Haxional Primary and secondary Ambient
                                   Air au«JJ.ey Standards
Type o*
Standard
Primary

Secondary
Primary

Secondary
«
Primary and
Secondary

Primary and
Secondary
Primary and
Secondary
Primary and
Secondary
Primary and
Secondary
Averaging
Time
1 year
24 hour
3 hour
1 year
24 hour
1 year
24 hour
8 hour

1 hour
1 hour

3 hour
(6-9 a.m. )
1 year

90 day

Frequency
Parameter u
Annual Arithmetic Mean
Annual Maximum*/
Annual Maximum 1
Annual Geometric Mean
Annual Maximum
Annual Geometric Mean
Annual Maximum
Annual Maximum 10

Annual Mmsfjimiin 40
Bcpeeted days per
year
Annual Maximum

Annual Arithmetic Mean

Maximum Arithmetic Mean

Concentration
2/mi
30
365
,300
75
260
6a£/
ISO
,000

,000
:35

was.'

100

1.5

222.
0.03
0.14
0.5
	
	
_ —
,—_
9

35
0.12

0.24£x

O.OS

	

    Pollutant

Sulfur Dioxide




Particulata Matter




Carbon Manoxide



Ozone


Hydrocarboni


nitrogen Dioxide

Lead
    .5/Mot eo be exceeded sore than once per year.

    £/Aa a guide to be used in a»eaaing  implementation plans to acnieve the 24-hour standard.

    2/As a guide in devising implementation plans to achieve ocone standards.

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                                   7-42
exclusion of cost and technical feasibility considerations.  The listing and
the standard must be based solely on scientific/medical criteria.  This, in
itself, distinguishes the regulation of chemicals under Sections 108 and 109
from other regulatory programs.

    For each chemical, all available scientific evidence is compiled in an air
criteria document and evaluated by EPA.  This procedure allows individual
standards to be based on different types and qualities of scientific
information.

CHEMICAL-BY-CHEMICAL ANALYSIS

    Sulfur Oxides

    The "Air Quality Criteria for Sulfur Oxides" paper was published by the
National Air Pollution Control Administration in January 1969, and was revised
by the Environmental Protection Agency in September 1973.  Section 108(c) of
the Clean Air Act grants EPA the authority to "review and as appropriate,
modify any criteria."  In light of new information presented by several
studies completed after the initial publication of the Criteria Document in
1969, EPA determined that a revision of the criteria was necessary.

    Sulfur oxides, according to the criteria document, include "sulfur oxides,
their acids and acid salts."  The revised document presents empirical effects
of sulfur oxides, primarily sulfur dioxide, based on published scientific
studies.  The document does not present precise dose-response relationships
for various concentrations of sulfur oxides because interactions between
sulfur oxides and other pollutants, and sulfur oxides and atmospheric
conditions make precise dose-response  relationships difficult to measure.
Rather, general statements are made about the effects that can be  expected
when sulfur oxides are present in the  atmosphere.

    Evaluations of the effects of sulfur oxides on health, visibility,
materials, and vegetation are included in the air quality criteria paper.  A
short discussion of the conclusions from these evaluations follows.

    Health Effects.  The presence of sulfur oxides in the ambient  air is
associated with respiratory disease and increased morbidity and mortality
rates.  This conclusion is "most firm" for short-term air pollution episodes,
"probable"  for long-term community exposures to air pollution, and
"conjectural" for long-term residence  in a polluted area.  These conclusions
were based on analyses of numerous epidemiological studies.1
     1J"Air Quality Criteria for Sulfur Oxides", EPA  1973.

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                                   7-43
                                 EXHIBIT 7-8

                     EFFECTS OF SULFUR OXIDES ON HEALTH

Short-Term Effects

(1) AT CONCENTRATIONS OF ABOUT 1500 ug/m3 (0.52ppm) of sulfur dioxide  (24
    hour mean), and suspended particulate matter increased mortality may
    occur.

(2) AT CONCENTRATIONS OF ABOUT 715 ug/m3 (0.25ppm) of sulfur dioxide and
    higher (24 hour mean), accompanied by smoke at a concentrtion of 750
    ug/m3 increased daily death rate may occur.

(3) AT CONCENTRATION OF ABOUT 715 ug/m1 iOJiSppin) of sulfur dioxide  (24
    hour mean), accompanied by particulate matter, a sharp rise_in illness
    rates for patients over age 54 with severe bronchitis may occur.

(4) AT CONCENTRATIONS OF ABOUT 600 ug/m3 (about 0.21 ppm) of sulfur  dioxide
    (24 hour mean), with smoke concentrations of about 300 ug/m3, patients
    with chronic lung disease may experience accentuation of symptoms.


(5) AT CONCENTRATIONS OF ABOUT 500 ug/m3 (0.19 ppm) of sulfur dioxide  (24
    hour mean), with low particulate levels increased mortality rates  may
    occur,

             NATIONAL PRIMARY STANDARD = 365 ug/m] (0.14 ppm)

(6) AT CONCENTRATIONS RANGING FROM 300 ug/m3 (0.11 ppm to 0.19 ppm)  of
    sulfur dioxide (24 hour mean), with  low particulate  levels, increased
    hospital admissions of older persons for respiratory disease may occur,
    absenteeism from work, particularly with older persons, may also occur.
Long-Term Effects

(1) AT CONCENTRATIONS OF ABOUT  120 ug/m1  (0.046 ppm)  of  sulfur dioxide
    (annual mean), accompanied  by smoke concentrations of  about  100 ug/m1,
    increased frequency and severity of respiratorydiseases  in  school
    children may occur.

(2) AT CONCENTRATIONS OF ABOUT  115 ug/m1  (0.04 ppm) of sulfur dioxide
    (annual mean), accompanied  by smoke concentrations of  about  160 ug/m1
    increase in mortality from  bronchitis  and from lung  cancer may occur.

(3) AT CONCENTRATIONS RANGING FROM 105 ug/m3 to 265 ug/m3  (0.037 ppm to
    0.092 ppm) of sulfur dioxide (annual mean), accompanied by smoke
    concentration of about 185  ug/m3, increased frequency  of  respiratory
    symptoms and lung disease may occur.

             NATIONAL PRIMARY STANDARD » 30 ue/m3  (0.03ippm).

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    High part.ic;ilace levels tend to accompany high sulfur dioxide  levels.   It
is difficult to"evaluate precisely the relative contribution of  each  of  these
pollutants to health effects.

    Exhibit 7-3 lists the health effects of various concentrations of sulfur
oxides which served as the basis for the short-term and  long-term  primary  air
quality standards.  These health effects range from absenteeism  from  work  to
increased mortality rates.

    Effects on Visibility.  According to EPA, it is possible to  estimate
visibility impairment (for various relative humidities)  from sulfur dioxide
concentrations although these estimations are not precise.  The  Agency
estimated that at a concentration of 235 micrograms per  cubic meter (0.10  ppn)
of sulfur dioxide and with a. relative humidity of 50 percent, visibility in
New York City may be reduced to about 5 miles.  The importance of  this effect:
on visibility is that as the visual range decreases below 5 miles, operations
at airports are increasingly delayed.

    Effects on Materials.  Based on laboratory and field studies of steel
plate corrosion rates under varying sulfur dioxide concentrations, EPA
concluded that considerable corrosion occurs at annual average sulfur dioxide
concentrations of 0.03 pptn to 0.12 ppm.  Specifically, EPA reported that at a
mean sulfur dioxide level of 0.12 pptn, accompanied by high particulate
levels,1 the corrosion rate for steel panels may be increased by 50 percent.

    EPA's air quality criteria lists a few other effects of sulfur dioxide on
materials.  Sulfur oxides pollution:

         •    contributes to the damage of all types of  electrical
              equipment;

         •    attacks building materials, e.g., limestone, marble,
              roofing slate, and mortar;

         •    discolors and deteriorates statuary and other works
              of art, certain textile fibers, leather, and paper;  and

         •    adversely effects the durability of oil-based paints.
    2Kigh particulate  levels tend to  accompany high  sulfur  dioxide  levels.
It is difficult to evaluate precisely the  relative contribution  of  each of
these pollutants to corrosion.  However, EPA  regards  sulfur dioxide as  the
more important factor  in corrosion.

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                                   7-45
    Effects on Vegetation.  The vegetational criterion primarily includes
scientific studies of vegetational effects resulting from exposure only to
sulfur dioxide.  Random interactions with other pollutants influence the
effects on vegetation, but unfortunately, such information about those effects
is limited.3  In addition, environmental factors such as high humidity,
sunlight, soil moisture, and temperature have been implicated in the criteria
document as influencing the susceptibility of vegetation injury from sulfur
dioxide exposure.  However, no scientific studies isolating the relative
importance of each environmental factor were cited.

    In the criteria document, EPA concludes from available data that growth
retardation and yield reduction of vegetation may occur at concentrations
greater than 1,300 ug/m3 (0.5 ppm) over a period of 3 hours.

    Revised Criteria Document.  EPA submitted a revised draft criteria
document for sulfur oxides on April 11, 1980.  In the revised document, EPA
combined sulfur oxides and particulate matter because these chemicals act
together to cause adverse health effects, according to the Agency.  The
Environmental Defense Fund emphasized the need for more information in the
criteria document about:

         •    what constitutes an adequate safety margin,

         •    the independent importance of sulfur oxides in
              health effects,

         •    the synergism between ozone and sulfur dioxide,

         •    short-term vs. long-term exposure to sulfur oxides
              and particulate matter, and

         •    the non-respiratory adverse health effects, e.g.,
              teratological, reproductive.

EPA plans to complete the revisions to the criteria document by November
1980.  At that point, the Agency will determine whether revisions of the
sulfur oxides national ambient air quality standards are necessary.

    National Ambient Air Quality Standards.  The term sulfur oxides is not
defined in the regulations; however, sulfur dioxide is specifically
    'Studies of interactions between sulfur dioxide and ozone, and sulfur
dioxide and oxides of nitrogen have been cited in the revised criteria
document.  These studies indicate that mixtures of sulfur dioxide and ozone,
as well as sulfur dioxide and nitrogen dioxide produce greater effects on
vegetation than sulfur dioxide alone.  (38 FR 25630, September 1&, 1973.)

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designated as -he chemical substance to be measured and controlled by the
primary and secondary standards.  The reason the N'AAQS apply only to sulfur
dioxide is because sulfur dioxide is:

         •    an indicator of the presence of sulfur oxides in
              polluted air,

         •    an important index of the effects which have been
              associated with sulfur oxides, and

         •    easily measurable.

    In 1971, EPA promulgated national primary standards for sulfur oxides.  A
short-tenn and a long-term standard were adopted.  They are:

         (a)  30 micrograms per cubic meter (0.03 pptn) -- annual
              arithmetic mean.

         (b)  365 micrograms per cubic meter (0.14 ppm) -- maximum
              24-hour concentration not to be exceeded more than
              once per year.

    Exhibit 7-8 illustrates the relationship between the primary standards and
the health effects associated with various concentrations of sulfur dioxide
exposure.  At the time they were promulgated, EPA claimed these standards
provided a "margin of safety adequate to protect the public health" from
adverse effects."  However, the primary standards were set at a level which
would clearly not protect against increased hospital admissions of older
persons and absenteeism from work (see (6) from Exhibit 7-8).

    The long-term standard, aroiual mean, is set at a level which should
protect against exposures to concentrations of sulfur oxides associated with
the long-term health effects mentioned in the 1973 criteria document.

    Currently, a major issue is whether the primary standards provide an
adequate margin of safety.  In addition, interactions between sulfur dioxide
and particulates may render the established primary standard insufficiently
restrictive to protect public health-  As a result, the Agency is considering
adopting a short-term, one-to-three hour sulfur dioxide standard based on
clinical evidence of adverse "oeak" short-term concentrations.b
    * 36 FK £186 (AorilSO. 1971).

    s Environmental Reporter. The Bureau of National Affairs, Inc., August
29, 1980, p. 661.

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                                   '-47
    The secondary standard for sulfur oxides adopted by EPA is 1,300
micrograms per cubic meter (0.5 ppm) maximum 3-hour concentration not to be
exceeded more than once per year.

    Out of the three possible welfare effects, cited in the criteria document,
i.e., effects on visibility,  materials, and vegetation, only injury to
vegetation was used by EPA to set the secondary standard.  The reason is that
injury to vegetation is the only welfare effect that can be quantitatively
related to ambient concentrations of sulfur oxides.  As discussed earlier ir.
the paper, such a precise quantitative relationship is necessary for secondary
standards under EPA's interpretation of the statute.  Sufficient data ara not
now available to establish a precise quantitative relationship between
specific sulfur dioxide concentrations and corrosion of materials or reduction
in visibility.

    Particulate Matter

    "Air Quality Criteria for Particulate Matter" was first published by the
National Air Pollution Control Administration in 1969.  The document defined
particulate air pollution as "any matter dispersed in the air, whether solid
or liquid, in which the individual particles are larger than small molecules
but smaller in diameter than 500 u where one u is one millionth of a xeter" (u
= one micron).s

    The criteria document identifies and evaluates the effects of particulata
matter in the air on health,  climate, visibility, materials, vegetation, and
public concern.7  Epidemiological studies cited in the criteria document
indicate an association between short-term exposures to certain concentrations
of particuiate matter and increased mortality and morbidity from damage to the
respiratory system.  The association between long-term community exposures to
particulate matter and respiratory disease incidence is "probable";
furthermore, the association between long-term residence in a polluted araa
and chronic disease morbidity and mortality is described in the criteria
document as "coniectural".'  Exhibit 7-9 summarizes the National Air
    '"Air Quality Criteria for Particulate Matter", NAPCA, January 1369.

    7As previously explained in the Sulfur Oxides section of this paper, EPA
currently is revising the particulate matter criteria document.  The first
external review draft of "Air Quality Criteria for Particulate Mattar and
Sulfur Oxides" was made available on April 11, 1980.  The revised document
combines sulfur oxides and particulates because these substances act together
to cause adverse health effects.

    "This is similar to the evidence of health effects from exposure to
sulfur oxides.

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                                   7-48



                                 EXHIBIT 7-9

                   EFFECTS OF PARTICULATE MATTER ON HEALTH
Short-Term Effects

(1)  AT CONCENTRATIONS OF 750 ug/m3 and higher for particulates on a 24 hour
     average, accompanied by sulfur dioxide concentrations of 715 ug/m3 and
     higher,  excess deaths and a considerable increase in illness may
     occur...

(2)  IF CONCENTRATIONS ABOVE 300 ug/m1 for particulates persist on a 24 hour
     average and are accompanied by sulfur dioxide concentrations exceeding
     630 ug/m1 over the same average period, chronic bronchitis patients
     will likely suffer acute worsening of symptoms...

                   NATIONAL PRIMARY STANDARD = 260 ug/m3

(3)  AT CONCENTRATIONS OVER 200 ug/m3 for particulates on a 24 hour average,
     accompanied by concentrations of sulfur dioxide exceeding 250 ug/m1
     over the same average period, increased absence of industrial workers
     due to illness may occur. .  . .
Long-Term Effects

(1)  WHERE CONCENTRATIONS RANGE FROM 100 ug/m1 to 130 ug/m3 and above for
     particulates (annual mean) with sulfur dioxide concentrations (annual
     mean) greater than 120 ug/m3, children residing in such areas are
     likely to experience increased incidence of certain respiratory
     diseases.

(2)  AT CONCENTRATIONS ABOVE 100 ug/m3 for particulates (annual geometric
     mean) with sulfation levels above 30 mg/cm2-mo., increased death rates
     for persons over 50 years of age are likely...

(3)  WHERE CONCENTRATIONS RANGE FROM 80 ug/m3 to 100 ug/m3 for
     particulates (annual geometric mean) with sulfation levels of about 30
     mg/ca1-mo., increased death rates for persons over 50 years of age may
     occur. . .  .

(4)  A DECREASE FROM 140 ug/m3 to 60 ug/m3 (annual mean) in particulate
     concentrations may be accompanied by a decrease in mean sputum volume in
     industrial workers....

                   NATIONAL PRIMARY STANDARD = 75 ug/m3

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                                   7-49
Pollution Control Administration's findings on health effects which were used
by EPA to establish the primary standards for particulars matter.

    Currently, a major issue concerns the relationship between the size of
individual particles and their adverse health affects.  Different sizes of
particles have different respirable characteristics, and hence, affect the
respiratory system differently.  It may be advisable to establish national
ambient air quality standards which differentiate between sizes of particles
on the basis of resulting health effects.

    Effects on Climate.  Particulate matter absorbs sunlight, produces haze,
reduces visibility, and increases rainfall in cities.  EPA estima-ed that
concentrations of particulate material from 100-150 micrograms per cubic meter
under certain conditions reduce direct sunlight up to one-third in suzmer and
two-thirds in winter.

    Effects on Visibility.  The primary implications of the reduced
visibility caused by particulate matter (and sulfur oxides) are for the safe
operation of aircraft.  Basically, EPA has determined that particulate
concentrations of 150 micrograms per cubic meter, may reduce visibility to as
low as 5 miles.

    Effects on Materials.  Particulate matter corrodes metals, damages elec-
trical equipment, soils and deteriorates buildings and textiles.  EPA focused
on the corrosion of steel and zinc panels to assess the effects of paticulate
matter on materials.  Specifically, EPA determined that concentrations of par-
ticulate matter ranging from 60 to 180 micrograms per cubic meter accelerate
the corrosion of steel and zinc panels.

    Effects on Vegetation.  EPA examined the effects of individual particu-
late air pollutants on vegetation rather than the combined effects of the many
particulates found in the ambient air.  Moreover, this information was not
used to establish air quality criteria for particulate matter because the ef-
fects on vegetation could not be quantitatively related to particuiata levels
in the ambient air.  EPA presented the information only for the purpose of
illustrating possible mechanisms through which particulate matter may affect
vegetation.

    Effects on Public Concern.  The air quality criteria document reviews
several studies which indicate a relationship between levels of particulate
pollution and levels of public concern over the problem.  EPA concluded that
concentrations of parziculatas above 70 ug/m: cause public concern for air
pollution; this concern increases proportionately with the concentrations of
particulate matter.

    National Ambient Air Quality Standards.  The regulations do not define
particulate matter, but the Preamble to the Proposed National Primary and Sec-
ondary Standards for Particulate Master, adopted the definition of particulate
mazter used in the 1969 criteria document:  "any matter dispersed in the air,

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                                    •-50
whether solid or liquid, in which the individual particles are larger than
small molecules but smaller than 500 microns."'

    In 1971, these national primary ambient air quality standards were pro-
mulgated for particulate matter:

         (a)  75 micrograms per cubic meter--annual geometric mean.

         CD)  260 micrograms per cubic meter--maximum 24-hour
              concentration not to be exceeded more than once per
              year.

    The standards do not differentiate between sizes of particles.  In. fact,
there are no equivalent standards in units of parts per million  (ppm) for pa: -
ticulate matter, because the size of particuiate matter varies too much  to
express the standards in terms of ppm.

    Exhibit 7-9 illustrates that long-term standard, standard (a), is set at  a
lower concentration than the concentrations cited in the criteria document as
adversely affecting health.  For this reason, EPA asserts that the primary
standard provides ar, adequate margin of safety.18  Standard  (b)  is set. re-
strictive enough to protect against concentrations shown to  cause excess
deaths, increased illness, and acute worsening of symptoms for chronic bron-
chitis patients.  However, the short-term standard is not restrictive enough
to protect against ambient concentrations which were shown to cause increased
absence of industrial workers due to illness.

    The national secondary ambient air quality standards "for particulate
matter are:

         (a)  60 micrograms per cubic meter--annual geometric mean.

         (b)  150 micrograms per cubic meter--maximum 24-hour
              concentration not to be exceeded more than once per
              year.

These secondary standards were selected to protect public welfare against the
effects on climate, visibility, materials, and public concern cited in the a:.r
quality criteria document.
     ' 36 FR  1502  (January  30,  1971).

     ! Ibid.

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                                   7-51
    Carbon Monoxide

    The first "Air Quality Criteria for Carbon Monoxide" was published in 1970
by the National Air Pollution Control Administration.  It includes a
toxicological and epidemiclogical appraisal of atmospheric carbor. monoxide
(GO).

    The toxicological evaluation is based on human exposure studies conducted
by Beard and Wertheim.11  These studies indicate that experimental exposure
of non-sniokers to 53 mg/mj (50 ppm) of carbon monoxide for 90 minutes is
associated with high levels of carboxyhemoglofain (CCHb) in human blood and
impairment in time-interval discrimination."  Higher concentrations of
carbon monoxide were shown to be associated with significant changes in
relative brightness threshold and visual acuity, as well as cardiovascular
changes which place an "exceptional burden" on some patients with heart
disease.l3

    The epidemiological appraisal identified the segments of the population
most susceptible to adverse health effects from atmospheric carbon jionoxide.
They include the developing fetus and individuals with anemia, cardiovascular
disease, abnormal metabolic states such as thyrotoxicosis or fever, and
chronic pulmonary disease.  In addition, epidemiological evidence was citad
which suggests an association between increased fatality rates in hospitalized.
myocardial infarction patients and exposure to weekly average CO concentra-
tions of the order of 9 to 16 mg/m3 (8 to 14 pom).

    The 1970 criteria document indicates that associations between ambient
levels of carbon monoxide and adverse effects on vegetation, materials, and
other aspects of human welfare have not been demonstrated.

    Revised Criteria Document.  On December 1, 1973  (43 7R 56250), EPA
announced that it was in the process of reviewing,  updating, and revising the
1970 criteria document for carbon monoxide in accordance with provisions of
    11R.R. Beard and G.A. Wertheim.  "Behavioral Impairment Associated with
Small Doses of Carbon Monoxide,"  American Journal of Public Health
57:2012-2022, 1967.

    l*High levels of carboxyhemoglobin (CCHb) in human blood result in
reduced oxygen-carrying capacity of blood since hemoglobin that has combined
with CO is not available to transport oxygen.  Cardiovascular, central
nervous, pulmonary, and other systems are adversely affected fay the reduced
delivery of oxygen to these systems.

    ll"Air Quality Criteria for Carbon Monoxide", National Air Pollution
Control Administration, March 1970.

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                                   7-52
Section 109(d)(l) of the Clean Air Act.  The revised criteria document was
published simultaneously with proposed revised standards on August 18, 1980
(45 FR 55066).  The significance of the revised criteria document is
twofold.  First, EPA rejected Beard and Werthein's toxicological svaluation
because attempts to replicate their study had been unsuccessful.  Second, a
new epidemiclogical appraisal focused attention on persons with angina and
other types of cardiovascular disease, e.g., peripheral vascular diseci.se, as
the most sensitive population to low-level, ambient exposures of carbon
monoxide.

    National Ambient Air Quality Standards.  NAAQS for carbon monoxide were
promulgated on April 30, 1971.  Carbon monoxide is not defined in the
regulations.

    The primary standards were based on the Beard and Wertheim study cited in
the 1970 criteria document.  These standards are:

         (a)   10 milligrams per cubic meter (9 ppm)—maximum
              eight-hour concentration not to be exceeded more than
              once per year.

         (b)   40 milligrams per cubic meter (35 ppm)--maximum
              one-hour concentration not to be exceeded more than
              once per year.

    According to EPA, the national primary standards for carbon monoxide are
intended to prevent the occurrence of carboxyhemoglobin levels above 2 percent
in human blood.  The criteria document points out that COHb levels above 2
percent in human blood affect the central nervous system resulting in
impairment in discrimination of time intervals.  At the time they were
promulgated,  EPA believed these standards provided an adequate safety margin
for the protection of public health, including the health of persons
especially sensitive to the effects of elevated COHb levels.^

    Adverse welfare effects have not been observed to occur at concentration
levels below the levels established for the primary standards.  Hence, the
secondary standards were specified at the same levels as the primary standards.

    Revised Standards.   After developing the revised criteria document, EPA
proposed revised NAAQS for CO on August 18, 1980 (45 FR 55066).  The Agency
proposed to retain the existing primary 8-hour standard at 9ppm and to lower
the primary 1-hour standard from 35 ppm to 25 ppm.  A more restrictive 1-hour
standard is necessary,  according to EPA, because of the more rapid accumula-
tion of blood carboxyhemoglobin in moderately exercising sensitive persons
    Ik36 FR 8186 (April30, 1971).  Preamble to Carbon Monoxide NAAQS.

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                                   7-53
compared to resting individuals.  The impact of exercise was not considered
when the original standard was established in 1971.

    Based on medical evidence presented in the criteria document, no clear
threshold of adverse health effects can be identified with certainty for COKb
levels; rather, a continuum exists consisting of CQHb levels shown to be asso-
ciated with adverse health effects, and levels where health effects are less
certain and mors difficult to identify.  Thus, selecting a standard that takes
into account the known continuum of effects "is a judgment of prudent public
health practice, and does not imply some discrete or exact margin of safety
appended to a known threshold."15

    EPA rejected the option of setting a zero-level standard as an expedient
means of protecting public health without having to decide among uncertain-
ties.  It is the Agency's belief that Congress did not intend EPA to "take the
easy way out" simply because the health evidence supporting a standard above
zero is beset with uncertainties.  Thus, the Agency based the decision as to
what standard protects public health with an adequate margin of safety on a
consideration of the uncertainty that any given level is low enough to protect
adverse health effects and on the relative acceptability of various degrees of
uncertainty, given the seriousness of the effects  (45 FR 55072).

    To determine how much the 1-hour standard should be reduced, EPA employee
the Coburn equation1' which permits the estimation of COHb levels that will
result from short-term (one- to eight-hour) exposures to ambient CO concentra-
tions .

    EPA focused on the most sensitive population,  i.e., individuals with car-
diovascular heart or peripheral vascular disease, when applying the Coburn
equation.  The results of this analysis indicate that more than 99 percent of
the sensitive group would not be expected to reach, or exceed, 2.1 percent
COHb upon exposure to an air quality associated with the proposed standards of
9 ppm averaged over eight hours or 25 ppm averaged over 1 hour.  Since the
lowest group mean COHb level convincingly linked to adverse health effects is
in the range of 2.7 to 2.9 percent and the proposed standards protect against
exceeding 2.1 percent COHb, then, the proposed standards should protect
against demonstrated adverse health effects.  The  proposed standards do not
afford a large degree of protection for the sensitive population, so EPA cur-
rently is soliciting comments from the public about whether the one-hour and
eight-hour standards provide an adequate margin of safety.
     1SPreamble to Proposed Revision of CO NAAQS, 45 FR 55072,  (Augut  13,
 1980).

     iSR.F. Cobum, R.E. Foster, and P.B. Kane,  "Considerations of the Phy-
 siology and Variables that Determine the Blood  Carboxyhemoglobin Concentra
 tions in Man," Journal of Clinical Investigation, 44:1399-1910, 1965.

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    To determine the margin of safety, EPA considered that uncertainties exist
regarding:

         •     the lowest adverse health effect levels from CO, as
              a result of variations in individual susceptibilities
              and the absence of negative clinical studies in the
              range of lower CO levels;

         •     additional potentially sensitive groups including
              fetuses, pregnant women, anemics,  visitors to high
              altitude locations, and persons on certain medications;

         •     the accuracy of the Cobum equation and EPA
              estimates;

         •     adverse health effects that may result from very
              short duration high-level CO exposures (the bolus
              effect); and

         •     possible interactions between CO and other
              pollutants.

    The proposed standard specifies a statistical standard rather than the
current deterministic (once-per-year) standard.   EPA believes that expressing
the standard in terms of the expected number of exceedances per calendar year
is more practical and logical than the deterministic approach.  The revised
ozone standard (43 FR 26967) also uses the expected exceedances format.

    Another change proposed in the revised standards, is to use a daily
interpretation for exceedance of the CO standard, so the exceedances will be
determined on the basis of the number of days on which one- or eight-hour
concentrations are above the standard levels.17  This approach also is
consistent with the revised ozone standard.

    The eight-hour averaging time was selected for the standard because most
individuals achieve equilibrium levels of COHb after 8 hours of exposure.  In
addition, most people are exposed to CO in 8-hour blocks of time (e.g., work,
sleep).  The one-hour averaging time was selected primarily because several
scientific studies have demonstrated adverse health effects for sensitive
persons after one- to two-hour exposures to carbon monoxide.

    Finally, EPA proposes to rescind the existing secondary standard because
CO concentrations of the magnitude necessary to produce detrimental effects to
    17E?A prefers the daily interpretation because it simplifies daily
reporting by eliminating a data step.

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                                   7-55
vegetation are rarely if ever observed in the ambient air.  The Agency
believes no secondary standard is necessary to protect public welfare from
ambient CO exposures (45 CFR 55076).

    Ozone (Photochemical Oxidants)

    the first air quality criteria document for photochemical oxidants was
published by the National Air Pollution Control Administration in 1970.  EPA
promulgated National Ambient Air Quality Standards for photochemical oxidants
in April 1971.  In accordance with the provisions of Section 109(d)(l) of the
Clean Air Act, EPA in 1977 began reviewing and updating the 1970 criteria
document.  This led to a revised version of the air criteria document
published by EPA in April 1978 and entitled "Criteria for Ozone and Other
Photochemical Oxidants".  Summaries of the key issues addressed by the revised
air criteria document follow.

    Photochemical Oxidant Precursors.   Photochemical oxidants result from
sunlight acting on volatile organic compounds (VOC) and oxides of nitrogen.
EPA issued a recommended policy for States to follow on the control of
volatile organic compounds as constituents in the formation of photochemical
oxidants (42 FR 35314, July 8, 1977).   This policy recommends the reduction
of VOC in surface coatings, process changes, and the use of control equipment
in order for States to meet oxidant NAAQS.   Four compounds were recommended
for exclusion from control because of their negligible photochemical
reactivity.  They arer

         •    Methane
         •    Ethane
         •    1,1,1-Trichloroethane (Methyl Chloroform)
         •    Trichlorotrifluoroethane (Freon 113)

The twelve compounds listed below are VOC of low photochemical reactivity.
These VOC should be controlled under EPA policy, but priority should be given
to controlling more reactive VOC first.

         •    Propane
         •    Acetone
         •    Methyl Ethyl Ketone
         •    Methanol
         •    Isopropanol
         •    Methyl Benzoate
         •    Tertiary Alkyl Alcohols
         •    Methyl Acetate
         •    Phenyl Acetate
         •    Ethyl Amines
         •    Acetylene
         •    N,N-dimethyl formamide

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                                   7-56
    Health Effects.  "Criteria for Ozone and Other Photochemical Oxidants"
assesses the human health effects from atmospheric ozone in taras of the
mechanical function of the lung, oxidant effects on asthmatics, respiratory
symptoms and headaches, eye irritation, mortality, susceptibility to bacteria:
infection, acceleration of the aging process, and biochemical effects.   In
brief, experimental and epidemiological studies are cited in the air criteria
document to support EPA's conclusions that:

         (1)  Experimental ozone exposures at concentrations of 0.30
              ppm are associated with changes in lung function that
              result in physical discomfort which, even among
              healthy people (and especially in people with
              respiratory illness), may restrict normal activity or
              impair the performance of tasks.

         (2)  Asthmatics represent the principal sensitive group of
              concern in setting the primary standard, since
              available evidence suggests that an elevated
              proportion of asthmatics experience attacks on days
              when the peak hourly oxidant concentrations exceed 90
              ug/m3 (0.25 ppm).

         (3)  Short-term ozone exposures between 0.15 and 0.25 ppm
              result in respiratory symptoms including throat
              tickle, chest tightness, coughing, wheezing and
              headache; respiratory sycptom severity increases with
              ozone concentration and exercise.

         O)  Ozone alone at ambient concentrations is not an eye
              irritant, but the total photochemical oxidant six is
              associated with eye irritation; an ozone standard will
              reduce eye irritation because control measures to
              reduce ozone will also reduce the eye irritation
              components of photochemical oxidants.

         (5)  No studies have conclusively linked exposure to ozone
              or photochemical oxidants with an increase in human
              mortality.

         (6)  Decreased resistance to bacterial infection probably
              occurs in humans as a result of ozone exposure; this
              health effect has been demonstrated by an increased
              rate of mortality in laboratory animals subjected to
              both a bacterial challenge and exposures to ozone, so
              the exact concentrations which are associated with
              increased susceptibility to bacterial infection in
              humans are not known.

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                                   7-57
         (7)  Ozone may accelerate the aging process in living
              organisms by inducing premature aging symptoms such as
              premature cartilage calcification, and severs
              depletion of body fat.

         (8)  Exposures of human subjects to ozone produces changes
              in blood biochemistry, including increased fragility
            ,  of red blood cells, and altered enzyme activities in
              the serum but these changes have not been linked to
              any clinical diseases.

    Effects on Vegetation.  According to the air quality criteria document
the effects of ozone on plants include visible foliar injury, increased leaf
drops, reduced plant vigor, reduced plant growth, and death.  The responses of
plants to ozone exposures are not linearly dependent on the dose; short-term
exposures at a given dose are more damaging than long-term exposures.

    Effacts on Visibility.  There is limited data suggesting an association
between ambient ozone and visibility degradation.

    Effects on Materials.  Ozone accelerates the deterioration of rubber,
textile dyes and fibers, and certain paints.  The effects of ozone on
materials ara linearlv dependent on the total dose sustained bv the material.
    National Ambient Air Quality Standard.  EPA s objective in setting
primary NAAQS is to select an ozone concentration that accurately considers
the existing medical evidence and  the uncertainties in this evidence, and
thus, will protect all population groups with an adequate margin of
safety..11  EPA, after considering all the scientific evidence presented in
the air quality criteria document, is forced to make judgments about the level
below the probable adverse health effect level that provides an adequate
margin of safety for sensitive persons.1'  The Agency considered the
"seriousness of the effects" when deciding what standard protects public
health with an adequate margin of safety.  On April 30, 1971, EPA promulgated
primary NAAQS for photochemical oxidants which were:

         based on evidence of increased frequency of asthma attacks
         in some asthmatic subjects on days when estimated hourly
         average concentrations of photochemical oxidant raached
         0.10 ppm.-*
    11 ii FR 8213,. (February 8, 1979).

    ''Preamble to Photochemical Oxidants NAAQS, 44 FR 8213, (February 3,
1979).

    :a?raanfale to NAAQS for Photochemical Oxidants, 36 F3 3136, Asril 30,
1971.

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                                   7-58
The standards were not directed at the other sensitive group, persons engaging
in exercise, because the validity of the data suggesting impairment of
athletic performance at various cxidant concentrations was questioned by EPA.
The 1971 primary standard was set at 0.08 ppm as a one-hour average, because
EPA believed this level allowed "a margin of safety which is substantially
below the most likely threshold level suggested by the data."

    The 1978 revised air criteria document led EPA to conclude that the most
probable level for adverse health effects in sensitive persons, as well as in
healthier persons who are exercising vigorously, falls in the range of 0.15 to
0.25 ppm.  Based on these findings, EPA proposed to raise the primary standard
from 0.08 ppm to 0.10 ppm in June 1978.  After receiving "informed scientific
opinion", the Agency concluded that 0.10 ppm provided a wider margin of safety
than was necessary to protect public health.21  Thus, EPA promulgated a
revised primary standard of 0.12 ppm on February 8, 1979.  According to EPA,
the 0.12 ppm standard is "necessary and sufficiently prudent" to protect
public health.21  The standard is attained when the expected number of days
per calendar year with maximum hourly average concentrations above 0.12 ppm is
equal to or less than 1.

    The April 1971 standard was established for the entire class of photo-
chemical cxidants, but there were not satisfactory methods for accurately and
reliably measuring this collective class of pollutants.  The reference method
cited in the regulations to estimate ambient cxidant levels and determine
compliance with the standard measured only ozone (not the total cxidant E:.X).
As a result, in the revised NAAQS promulgated on February 8, 1S79, EPA
redesignated the standard from photochemical oxidants to ozcne.  Thus, the
revised standards are entitled, "National Primary and Secondary Ambient Air
Quality Standards for Ozone."

    EPA based the secondary ozone air quality standard on information
available concerning growth and yield reduction in commercially important
crotss and indigenous vegetation exposed to ozone under field conditions.23
From the available data, EPA concluded that there is no evidence cf a
significant decrease in growth or yield of commercially important crcps cr
indigenous  flora at the primary standard concentration level (0.12 ppm).  EPA
decided that a secondary standard more stringent than the primary standard is
not necessary to prevent ozone-related yield reduction effects in vegetation.
Furthermore, EPA determined that there would be no measurable reduction in
materials damage if a more stringent secondary standard level were selected;
     21 44 FR 8217  (February 8, 1979).

     22 Ibid.

     23 44 FR 8217  (February 8, 1979).

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                                   7-59
EPA also detarmir.ec that a secondary ozone standard more stringent than the
primary standard is not necessary to prevent visibility degradation.  In
conclusion, the secondary ambient air quality standard for ozone is the saraa
as the primary standard--12 ppm.

    Hydrocarbons

    "Air Quality Criteria for Hydrocarbons" was published by the National Air
Pollution Control Administration in March 1970.  The criteria for
hydrocarbons2" result primarily from their role as precursors of other
compounds formed in the atmospheric photochemical system and not from the
direct effects of hydrocarbons themselves.  This is allowed under the Clean
Air Act where the key factor is for a chemical to "contribute to air
pollution which may reasonably be anticipated to endanger public health or
  •* j?    i»
weltare.

    EPA, currently, is reviewing a draft criteria document for hydrocarbons
(45 FR 15262, March 10, 1980).  This draft argues against revising the 1STO
criteria document, because EPA believes that hydrocarbons at currant ambient
levels do not pcse significant health or welfare risks.  The Agency maintains
that the 1971 standards adopted for hydrocarbons have successfully assisted
states in determining the level of hydrocarbon emission reductions necessary
to meet the ozone MAAQS.

    Health Effects.  No direct health effects from hydrocarbons in the
ambient air on populations have been documented.  However, ambient levels of
hydrocarbons are indirectly related to health effects attributed to
photochemical smog, e.g., eye irritation, respiratory symptoms.

    The criteria document shows that nonmethane hydrocarbon concentrations of
200 ug/m3 for the three hour period from 6:00 to 9:00 a.m. can be expected
to produce a maximum hourly average concentration of ozone up to 200 ug/m3
(0.1 ppm).  This level of ozone, 0.1 ppm, is below the 0.15 ppm concentration
viewed as the most probable level for adverse health effects in sensitive
persons (see previous section on Ozone).  However, given the effects on ozone
from other actors in the atmospheric photochemical system, the criteria
document concludes that hydrocarbon contribution of up to 0.1 ppm of ozone
must be controlled in order to protect public health from the adverse effects
of ozone.

    Effects on Vegetation.  Studies cited in the criteria document report
that injury to sensitive plants is associated directly with ethylene (a
    2*The air quality criteria document defines this group of air pollutants
as "gas-phase hydrocarbons and certain of their oxidation products,
particularly aldehydes."

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                                    :-60
hydrocarbon) concentrations of from 1.15 to 575 ug/m3 (0.001 to 0.5 ppm)
over a time period of 8 to 24 hours.

    National Ambient Air Quality Standards.  The sole purpose cf prescribing
hydrocarbon standards*5is to control photochemical oxidants.26  When
promulgating primary air quality standards for hydrocarbons, EPA examined
their contribution to the formation of photochemical cxidants.   In this way,
the health effects indirectly resulting from hydrocarbons served as the basis
for establishing the primary standards.

    EPA established the national primary standard for hydrocarbons at 160
micrograms per cubic meter (0.24 ppm)--maximum three-hour concentration (6 to
9 am) not to be exceeded more than once per year.  EPA determined that this
ambient air concentration of hydrocarbons would permit states to meet the
ozone NAAQS.

    The secondary standards for hydrocarbons were established at the same
concentration level as the primary standards--160 ug/m3.   It is EPA's belisf
that a more stringent standard is unnecessary because adverse welfare effects
have not been observed to occur at levels below the levels of the primary
standards.

    Nitrogen Oxides

    "Air Quality Criteria for Nitrogen Oxides" was published by the
Environmental Protection Agency in January 1371.  Tne document discusses only
the direct effects of nitrogen oxides and not the indirect effects through the
photochemical reaction mechanism.  Effects of both nitric' oxide and. nitrogen
dioxide, are included in the criteria document, but the promulgated standard
applies only to nitrogen dioxide.  Consequently, this paper will summarize
only that portion of the air criteria document dealing with nitrogen dioxide
(N02).

    Under the Clean Air Act Amendments cf  1577 Section 108 (c.) , EPA was
required to review the need for a short-term, at most three-hour, ambient
nitrogen dioxide standard.  In addition, Section 109(c) directs EPA to adopt a
short-term primary standard for N0? if the scientific evidence indicates
such a standard is necessary.  In accordance with the 1977 Amendments, EPA
issued a document entitled, "Health Effects of Short-Term Exposure to Nitrogen
Dioxide" on December 19, 1977 (42 ?R 63460).  Thus far, a short-term standard
for N0? has not been promulgated.
  •  *5The promulgated standard applies to all hydrocarbons, but the term
"hydrocarbons" is not defined in the regulations.

    :636 FR 8156  (April 30, 1971).

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                                   7-61
    On December 12, 1973, EPA announced the availability of the  first external
review draft of the revised criteria document for oxides of nitrogen.  The
second external review draft was made available on July 11, 1979.  N'o final
revision of the criteria document has been issued.

    Exhibit 7-10 outlines the health effects of nitrogen dioxide v.iich served
as-the basis for the long-term primary air quality standard.  The intensity o:
the response to nitrogen dioxide was given little consideration  in assessing
potential health risks to various concentrations of NCL.


    Effects on Vegetation.  The air criteria document discussed  three affects
on vegetation.  They were:

         (1)  Exposure to 470 ug/ni3 (0.2S ppm) of nitrogen dioxide
              for eight months caused leaf abscission and decreased
              yield among navel oranges.

         (2)  Exposure to nitrogen dioxide concentrations of 9^0
              ug/m3 (0.5 ppm) for 35 days resulted in leaf
              abscission and chlorosis on citrus fruit trees.

         (3)  Exposure to nitrogen dioxide concentrations of 1.9
              mg/m3 (1 ppm) for one day can cause overt leaf
              injury to sensitive plants.

    Effects on Materials.  Damage to materials, particularly the corrosion of
electrical components, has been attributed to nitrogen dioxide in ambient
atmospheres, but the precise concentrations producing these effects has not
been determined.

    National Ambient Air Quality Standards.  Tne primary standard for
nitrogen dioxide is 100 micrograms per cubic meter (0.05 ppm) annual
arithmetic mean.  The level of this standard is more restrictive than the
health-effect-related value of 113 ug/m3 (0.06 ppm) yearly average, cited
above.  No short-term standard for N'O- has been promulgated yet  to protect
human health from the short-term exposure effects listed in Exhibit 7-3.

    EPA set the secondary standards at the same level as the primary
standard--100 ug/m3.  This level, according to EPA, will prevent the effects
on vegetation listed above.

         Lead
         "Air Quality Criteria for Lead" was published by the Environmental
Protection Agency in December 1977 as a result of a  law suit brought  against
EPA by the Natural Resources Defense Council (NRDC)  in 1975.  The Court ruled
in favor of NRDC, and ordered EPA to list  lead as a  pollutant under Section
108 of the Clean Air Act.  EPA listed lead on March  31, 1976, and then
developed the air quality criteria.  Prior to the lawsuit, EPA intended to

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                                 EXHIBIT 7-10

                  HUMAN HEALTH E~ECTS CF NITROGEN DICXIpE


(1).  Sbcrt-Tera Exposure.   Limited studies show that exposure to NO, for
     less  than 24 hours continuously can have several concentration-dependent
           s.
     1.    The olfactory threshold value of NO, is about 225 ug/tn' (0.12

          ppm).

     2.    Exposure to 9.4 mg/m'  (5 ppm) for 10 minutes has produced
          transient increase in  airway resistance.

     3.    Occupational exposure  to 162.2 mg/m3 (90  ppm) for 30 minutes has
          produced pulmonary edema IS hours later,  accompanied by an observed
          vital  capacity that was 50 percent of the value predicted for normal
          f unct ion.

     long-Term Exposure.  An increased incidence of acute respiratory disease
     was observed in family groups when the mean range of 24-hour NC
     concentrations, measured over a 6-month period, was between 117 and 2C5

     ug/tc3 (0,062 and 0.109 ppm) and the mean suspended nitrate level-
     during the  same period was  3.3 ug/m3 or greater.

          The frequency of acute bronchitis increased among infants and school
     children when the range of  mean 24-hour NO,, concentrations, measured
     over a 6-month period, was  between 118 and 156 ug/m3 (0.063 and 0.063
     ppm) and the mean suspended nitrate level during the sane period was 2.6
     ug/'mj or greater.

          Yearly average NO, concentrations exceed the Chattanooga
     healtheffeet-related value  cf 113 ug/m3  (0.06 ppm) in 10 percent of
     cities in the United States with populations of less than 50,000, 54
     percent of  cities with populations between 50,000 and 500,000, and S5
     percent of  cities with populations over 500,000.
     a/ Suspended, nitrates are particulate matter.

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                                   7-63
control lead in the air by limiting emissions from automobiles and by
controlling emissions from certain categories of industrial point sources
under Section 111.

     Health Effects.  The air criteria document reviewed  the  toxic effects  of
lead resulting from high levels of exposure.  These  include colic, palsy, and
encephalopathy.    In addition, the longer-term,  low level  exposure effects were
examined.  These  low-exposure-level effects are listed  in Exhibit 7-11.
According to the  criteria document, lead accumulates  in the human body
throughout life.  Blood lead concentrations respond  to  changes in the level of
environmental exposure; the threshold for  a particular  health effect is
defined as the blood lead level at which the effect  is  first  detected.

     The criteria document identifies several groups  for  which lead exposure
poses a greater risk than for the general  population.   These  include young
children, pregnant women and the fetus, the occupationally exposed, and
individuals suffering from dietary deficiencies or exhibiting the genetic
inability to produce certain blood enzymes.

     Welfare Effects.  The criteria document cites scientific evidence which
demonstrates that animals are not more susceptible to adverse effects from
lead than humans  and that adverse effects  in animals  do not occur at lower
levels of exposure  than comparable effects in humans.   (Grazing  animals may be
exposed to lead deposited on the leaves of plants,)   The  document presents
data indicating that atmospheric sources of lead may  be injurious to plants,
since the chemical  is absorbed by plants from soil.   It is pointed out,
however, that lead  is generally in a. form  that  is not available  to plants.
There is no evidence presented in the paper to  indicate that  ambient levels of
lead result in significant damage to materials.  Finally, the document
describes the effects of lead on visibility and climate as "minimal".

     National Ambient Air Quality Standards.  In developing the  primary
standard, EPA made  several policy determinations which  are summarized in
Exhibit 7-12.  EPA  determined that young children  (aged one to five years)  are
the group within  the general population that is particularly  sensitive to lead
exposure.

     To determine the pivotal adverse health effect,  EPA  examined the criteria
document.  The document indicates that the lowest blood level of lead for
functional impairment is 15 to 20 ug Pb/dl.  EPA also determined that the mean
population blood  lead level for children should not  exceed 15 ug Pb/dl.  This
is the lowest value presented in the criteria document  as a threshold below
which the sensitive population as a group  (children)  has  not  shown a
functional impairment due to lead and above which there are increasing
implications for  health.

     To estimate  the relationship between  air lead exposure and  resulting
blood lead levels,  the criteria document concludes:

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                                   7-64



                                 EXHIBIT 7-11

                     LOW-EXPOSURE HEALTH EFFECTS OF LEAD
  Lowest Level For
  Observed Effects
(ug Pb/dl Whole Blood) a/

         10

      IS to 20


      20 to 25


         40


         40

         40

         SO

      50 to 60

      50 co 60

      80 to 100

     100 to 120
Observed _Effeet

ALAD inhibition b/

Free erythrocyte
porphyrin elevation

Free erythrocyte
porphyrin elevation

Increased urinary
ALA excretion

Anemia

Coproporphyrin elevation

Anemia

Cognitive (CNS) deficits

Peripheral neuropathies

Encephalopathy symptoms

Encephalopathy symptoms
 Pou.ation Grou
Children and nJ

 Women and children


 Adult Males


 Children and •:• du .t t &


 Children

 Adults and children

 Adults

 Children

 Adults and cVi'.ircu

 Childran

 Adults
a/ ug Pb/dl is micrograms of lead per deciliter of blood.

b/ Inhibition of the enzyme aminolevulinic acid dehydratase  (ALAD)  rep'rc's^
    the lowest level effect of lead that has been detected  (10  ug Pb/d,1)-
    ALAD inhibition at this level is not regarded as a physiological
    impairment of the system.  Thus, 15 to 20 ug Pb/dl is regarded  as  r,h?
    lowest level effect of lead that is associated with  functional  imp:- Lrnv

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                                   7-65
                                 EXHIBIT 7-12

                      EPA CONSIDERATIONS IN DEVELOPING
                          THE LEAD PRIMARY STANDARD
     Judgments

Determining the critically
     sensitive population

Determining the pivotal
     adverse health effect

Determining the mean population
     blood lead level which would
     be consistent with protection
     of the sensitive population

Determining the relationship between
     air lead exposure and
     resulting blood lead level

Determining the allowable blood
     lead increment from air
     Final Decisions
Young Children (ages 1-5 yaars)
Functional Impairment (15 to
     20 ug Pb/dl)

Threshold for Functional Impairmer
     (15 ug Pg/dl)
1 ug Pb/m  air :  2 ug Pb/dl blood
3 ug Pb/dl

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                                    " -66
    "Evidence [from clinical and.' epidemic logical studies] :_nd;,cates
    that a positive relationship exists between blood and air  lead
    levels, although the exact functional relationship has not yet
    been clarified.  Available data indicate that in the range of
    air lead exposures generally encountered by the population, the
    ratio of the increase in blood lead per unit of air lead is from
    1 to 2.  The range of ratios for children's blood lead response
    to a one ug increase in air lead is from 1.2 to 2.3."

To clarify this statement, the ratios between air lead exposures and blood
levels range from 1:1 to 1:2.  For chidren, this ratio ranges  from 1:1.2  to
1:2.3.  EPA selected a ratio of 1:2 to calculate the impact of air lead levels
on blood lead levels in children.

    Finally, EPA had to determine the allowable blood lead increment from air,
since significant amounts of the lead pollutant result from non-air sources.
This aspect of developing the ambient standard for lead distinguishes  it  from
all other pollutants previously addressed by EPA under Section 109 of  the
Clean Air Act.  The level selected as the basis for determining the allowable
contribution from air is a policy choice rather than an exact  calculation.
The reason for this is that the non-air contribution to blood  lead varies from
time to time and place to place.  Thus, EPA must make a policy choice  which
reflects how much of the lead pollution problem should be controlled through
air pollution control programs.

    From evaluating the epidemiological and isotopic tracing studies present-ad
in "Air Quality Criteria for Lead", EPA concluded that approximately two-
thirds of blood lead is typically derived from non-air sources.  Since the
average blood lead level in areas where air lead exposure is low is 12.7  ug
Pb/dl, EPA assumed that 12 ug Pb/dl of the blood lead level in children
results from non-air lead sources.

    To calculate the air standard EPA estimated the allowable  contribution to
blood lead from air sources to be:

     Allowable Total  -  Contribution from         = Allowable Contribution
      Lead Exposure       Non-Air Sources               from Air Sources

      (15 ug Pb/dl)   -  (12 ug Pb/dl)             =        3  ug Pb/dl

The air lead concentration consistent with the blood lead contribution from
air sources was estimated to be:

       Allowable Contribution  x  Ratio of Air Lead Levels  =    Primary
          from Air Sources          to Blood Lead Levels         Standard
                                              3                             3
         3 ug Pb/dl            x     1 ug Pb/m . air          = 1.5 ug Pb/m
                                   2 ug Pb/dl blood
Kence, the primary ambient air quality standard for lead is 1.5 ug Pb/m3,
maximum arithmetic mean averaged over a calendar quarter.

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                                   7-67
    EPA selected a calendar quarter as "he averaging period for the standard
to protect against variations in exposure which could result in adverse
effects.  EPA originally proposed an averaging period of a calendar month, but
extended the time period to a calendar quarter to improve the validity of  lead
air quality data gathered to monitor progress toward attainment of the
standard.  Tae Agency believes extending the averaging period to a calendar
quarter will not significantly reduce the protectiveness of the standard.
This conclusion is based on the following factors:27

         (1)  From actual ambient measurements, there is evidence
              that the distribution of air lead levels is such that
              if the quarterly average was achieved there is little
              possibility that there could be sustained periods
              greatly above the average value.

         (2)  It seems likely that where elevated air lead levels do
              occur, they will be close to point or mobile sources.
              Typically, young children will not encounter such
              levels.

         (3)  There is medical evidence indicating that blood lead
              levels equilibrate slowly to changes in air exposure.
              This serves to dampen the impact of a short-term
              period of exposure to elevated air lead.

         (4)  Direct exposure to air is only one of several routes
              of total exposure.  This lessens the impact of a
              change in air lead on blood lead levels.

    EPA based the secondary standard on the welfare effects described in the
criteria document.  The Agency concluded that the primary ambient air standard
would protect the public welfare adequately and EPA promulgated the secondary
standard at 1.5 ug Pb/m3.

    Lega1 Cha11enges.  The Lead Industries Association legally challenged  the
national ambient air quality standard for lead.  The federal appeals court
ruled in favor of EPA on June 27, 1980.  The court ruled that EPA is not
required to consider economic and technological feasibility in adopting ihe
ambient standards.  The court decided that EPA's determinations of adverse
health effects from lead concentration levels were "not arbitrary or
capricious and were supported by the evidence".28  This court decision
affirms EPA's current procedure for establishing national ambient air quality
standards.
    27 Preamble to the NAAQS  for Lead, 43 FR 46255  (October 5,  1973).

    11 Lead Industries Association v. EPA,  14 ERG 1906  (D.C. Cir.  133Q) ,
cer^;. den. 	 U.S. 	  (1980).

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                                   7-68
             NEW SOURCE PERFORMANCE STANDARDS—REGULATORY REVIEW
INTRODUCTION

    This section reviews the New Source Performance Standards (NSPS)
promulgated under the authority of Section 111 of the Clean Air Act in order
to:

          •    identify the chemical substances which have been
               designated for regulation under Section 111, and

          •    examine the designation criteria used by EPA.

    First, the requirements for establishing new source performance standards;
are reviewed.  Then, the specific pollutants addressed by these standards are
identified and the designation criteria specified.

OVERVIEW

    The Standards of Performance for New Stationary Sources promulgated under
the authority of Section 111 are located in 40 CFR 60.  Thus far, twenty-nine
source categories have been regulated.  NSPS currently adopted include these
three types:

         (1)  emission limitations for a given source category,

         (2)  specified percentage reductions in emissions, and

         (3)  equipment, work practice, etc. standards.

The third type of standard applies in cases where it is not feasible to
prescribe or enforce a standard of performance.  In such cases, EPA is
authorized under Section lll(h)(l) to promulgate "a design, equipment, work
practice, or operational standard, cr combination thereof which reflects th-»
best technological system of continuous emission reduction."

    In accordance with the legislative purpose and statutory requirements, new
source performance regulations are organized according to sources rather than
according to pollutants.  All emissions of all pollutants from a stationary
source and their effects on public health and welfare may be considered by EPA
when determining whether to regulate the source category.  If EPA determines
that the emissions from a source category have the potential to endanger
public health or welfare, then the category is regulated under Section 111.
This determination may be made before or after the Agency has identified which
specific pollutants £n the total emission pool are responsible for the
"potential to endanger public health or welfare."  However, in general,

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                                   7-69
sources are designated for regulation because specific chemicals believed to
pose health and welfare risks are identified in their emissions.

DESIGNATED POLLUTANTS

    Each new source performance standard issued through January 1, 1331,
includes emission limits for one or more of the following pollutants:

    •    Particulate Matter                   •  trichlorethylene
    •    Sulfur Dioxide                       •  perchloroethyiene
    •    Nitrogen Oxides                      •  1,1,1 trichioroethane
    •    Carbon Monoxide           '           •  methylene chloride
    •    Volatile Organic Compounds (VOC)     •  trichlorotrifluroethane
    •    Sulfuric Acid Mist
    •    Fluorides
    •    Total Reduced Sulfur (TRS)

These chemicals or classes are referred to as "designated pollutants".  This
is to distinguish them from the "criteria pollutants" regulated under Section
109 and "hazardous air pollutants" which are regulated under Section 112.

    The designated pollutants are defined as:

    (1)  Particulate Matter which means any finely divided solid or liquid
material, other than uncombined water  (as measured by specified reference
methods, or an equivalent or alternative method) (40 CFR 60.2).

    (2)  Sulfur Dioxide which is not defined in the regulations.

    (3)  Nitrogen Oxides which means all oxides of nitrogen except nitrous
oxide, as measured by specified test methods (40 CFR 60.2).

    (4)  Carbon Monoxide which is not  defined in the regulations.

    (5)  Volatile Organic Compounds which means any organic compound that
when released to the atmosphere can remain long enough to participate in
photochemical reactions  (44 FR 49223,  August 21, 1979).

    Volatile Organic Compounds of negligible photochemical reactivity
include:1

          •    Methane
          *    Ethane
          •    1,1,1- Trichioroethane  (Methyl Chloroform)
          •    Trichlorotrifluoroethane (Freon 113).
     1  42  FR  2S314  (July  3,  1977).

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                                    7-70
     Volatile Organic Compounds of low photochemical reactivity vhich only
participate in photochemical reactions curing multiday stagnations include:2

          •    Propane
          •    Acetone
          •    Methyl Ethyl Ketone
          •    Methanol
          •    Isopropanol
          •    Methyl Benzoate
          •    Tertiary Alkyl Alcohols
          •    Methyl Acetate
          *    Phenyl Acetate
          •    Ethyl Amines
          •    Acetylene
          •    N,N-dimethyl fonaamide

     (6)  Sulfuric Acid Mist expressed as K?SO,,  which means acid mist

(as measured by Method 8 of Appendix A to the regulations, or an equivalent or
alternative method) (40 CFR 60.81).

     (7)  Fluorides which means total fluorides which are elemental fluorine
and all fluoride compounds (as measured by reference methods specified in 40
CFR 60.195 or by equivalent or alternative methods) (40 CFR 60.191).

     (8)  Total Reduced Sulfur which means the sum of the sulfur compounds
hydrogen sulfide, methyl mercaptan, dimethyl sulfide, and dimethyl disulfide,
that are released during the kraft pulping operation and measured by Reference
Method 16 (40 CFR 60.281).

     (9)  Trichloroethylene, Perchloroethylene, 1,1,1 Trichlcroethane,
Methylene 'Chloride, and Trichlorotrifluroethane are halogenated solvents
designated under the proposed NSPS for organic solvent cleaners and were not
further defined through CAS numbers or synonyms.3

     It should be noted that new source performance standards have been
promulgated to control visible emissions in addition to the eight designated
pollutants.  Visible emissions in air constitute a physical safety hazard
(e.g., like noise) but are not hazardous due to their chemical composition.
Consequently, these standards are not reviewed here.

     Since one purpose of new source performance standards is to assure that
new sources do not prevent the attainment or maintenance of National Ambient
     2 Ibid-

     3See 45 FR 39766  (June 11, 1980).

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                                   7-71
Air Quality Standards, EPA established NSPS for five of the seven criteria
pollutants.  These five are particulate matter, sulfur dioxide, nitrogen
oxides, carbon monoxide, and volatile organic compounds.  Volatile organic
compounds are considered a criteria pollutant because they include
hydrocarbons and because they contribute to ambient levels of photochemical
oxidants.  Hence, the designation of these five chemicals for regulation under
Section 111 was based on their designation as criteria pollutants/ and thus,
on the evidence of health and/or welfare effects cited in the Air Quality
Criteria Documents prepared under Section 109.  A thorough discussion of these
health and welfare effects can be found in the National Ambient Air Quality
Standards Regulatory Review.

    EPA cited health-related effects as the rationale for including sulfuris
acid mist as a designated pollutant."  Furthermore, fluorides and total
reduced sulfur were designated primarily on the basis of adverse welfare
effects.  Specifically, fluorides are believed to damage vegetation and TRS
has been shown to damage paint materials.  In addition, TRS produces a foul
odor which is considered an adverse welfare effect.

    The five halogenated solvents specifically designated uner the NSPS for
organic solvent cleaners were listed for several reasons.  As ozone precursors
(i.e., volatile organic compounds photochemically reactive), both
perchloroethylene and trichloroethylene are subject to control based on the
health criteria for ozone.  EPA cited other possible health effects as
additional reasons for designating these substances, including evidence of
possible carcinogencity of perchloroethylene, trichloroethylene, methylene
chloride, and 1,1,1-trichloroethane.  Finally, both trichlorotrifluoroethane
and 1,1,l^trichloroethane were cited as being implicated 'in the depletion of
the stratospheric ozone layer which shields the earth from harmful ultraviolet
radiation that increase skin cancer risks in humans.  Of note is the fact that
control of these five solvents was also proposed under Section III(d) for
existing sources.

    Exhibit 7-13 summarizes the criteria used by EPA to designate chemicals
for regulation under Section 111.


STANDARDS

    As previously discussed, the Clean Air Act explicitly specifies the
criteria to be used to establish standards of performance.  NSPS are to be
based exclusively on the best adequately demonstrated technological system of
continuous emission reduction, taking into account non-air quality health,
environmental, and energy impacts, as well as other costs.  The standards for
designated pollutants are based on these statutory criteria.
    ''Discussions with staff of the Office of Air Quality Planning and
Standards, EPA.

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                                 EXHIBIT 7-13




                            DESIGNATION CRITERIA
                Pollutant
             Particulate Matter




             Sulfur Dioxide




             Nitrogen Oxides




             Carbon Monoxide




             Volatile Organic Compounds




             Sulfuric Acid Mist




             Fluorides




             Total Reduced Sulfur




             Perchloroethylene




             Trichloroethylene




             Methylene Chloride




             Trichlorotrifluroethane




             1,1,1-Trichloroethane
Designation Criteria




   Criteria Pollutant




   Criteria Pollutant




   Criteria Pollutant




   Criteria Pollutant




   Criteria Pollutant




   Health Effects




   Welfare Effects




   Welfare Effects




   Health Effects




   Health Effects




   Health Effects




   Health Effects




   Health Effects
*Prooosed NSPS.

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                                   7-73
                       NATIONAL EMISSION STANDARDS FOR
                 HAZARDOUS AIR POLLUTANTS--REGULATORY REVIEW
INTRODUCTION

    This section summarizes the National Emission Standards for Hazardous Air
Pollutants (NESHAPs) promulgated or proposed under the authority or Section
112 of the Clean Air Act in order to:

         •    identify the chemical substances which have been
              designated as hazardous air pollutants (HAPs) under
              Section 112;

         •    examine the criteria used by EPA to list chemical
              substances as hazardous air pollutants;

         •    review the emission standards for HAPs; and

         •    review the criteria used by EPA to set the emission
              standards.

OVERVIEW

    Regulation under Section 112 is a two stage process:  First, chemicals are
designated and listed as hazardous air pollutants, and then., emission
standards are issued.l

    To be listed as a hazardous air pollutant, the statutory definition of the
term "hazardous air pollutant" must apply to the chemical.  According to
Section 112, "the term hazardous air pollutant means an air pollutant to which
no ambient air quality standard is applicable and which in the judgement of
the Administrator causes, or contributes to, air pollution which nay
reasonably be anticipated to result in an increase in mortality cr an increase
in serious irreversible, or incapacitating reversible illness."

    In the past, potential health hazards of a chemical have been brought -o
EPA's attention through scientific reports published in journals, other
agencies investigating a particular chemical, and the Environmental Defense
Fund asserting concern about a chemical.  When EPA decides that the evidence
of a particular chemical contributing to "air pollution which may reasonably
be anticipated to result in an increase in mortality or an increase in serious
irreversible, or incapacitating reversible illness," is sufficient, the
Administrator will list the chemical as an HAP.
    lSee Exhibit 7-14:  Regulatory Chronology.

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                                    •-1U
    If EPA decides thai; an emission standard is necessary to protect the
public health, it will propose a standard which provides "an ample margin  of
safety to protect the public health from such hazardous air pollutant."2   If
an emission standard is not feasible, EPA will issue "a design, equipment,
work practice, or operational standard, or combination thereof which is
adequate to protect the public health with an ample margin of safety."3

    Although the definition of hazardous air pollutant in Section 112(a)(l)
specifies the health effects which determine a hazardous air pollutant  ("an
air pollutant which may reasonably be anticipated to result in an increase in
mortality or an increase in serious irreversible, or incapaciting reversible
illness"), it allows EPA to decide what types of tests are sufficient to
conclude that a chemical "causes or contributes" to air pollution, what types
of tests provide enough information to conclude that a chemical presents a
health hazard, how important other agency regulatory actions are, etc.  In
addition, under Section 112 the language, "ample margin of safety" allows  some
room for regulatory flexibility in determining appropriate emission standards.
DESIGNATION CRITERIA

    EPA has designated and listed seven chemicals as hazardous air pollutants:

         •    Abestos
         •    Beryllium
         •    Mercury
         •    Vinyl Chloride
         •    Benzene
         *    Radionuclides
         •    Inorganic Arsenic

    National Emission Standards have been promulgated or proposed for the
first five chemicals listed, as of January 1,  1981.  National Emission
Standards for radionuclides and inorganic arsenic, as yet, had not been
proposed by January 1, 1981.  In addition, an  air carcinogen policy was  also
proposed but not finalized.

    Exhibit 7-14 presents a chronological review of the regulatory actions
related to Section 112 of the Clean Air Act.   The two-stage process of  listing
and promulgating emission standards is apparent from this regulatory
chronology.
    2Clean Air Act, Section  112(b)(1)(3).

    'Clean Air Act Section 112(e)(l).

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                                   7-75
                                 EXHIBIT 7-14

                           REGULATORY CHRONOLOGY:
          NATIONAL EMISSIONS STANDARDS FOR HAZARDOUS AIR POLLUTANTS
     Data

March 31, 1971


December 7, 1971



April 6, 1973



December 24, 1975

December 24, 1975

Ocrober 21, 1976

June 3, 1977

Ocrober 10, 1979

October 10, 1979


December 27, 1979

April 3, 1980


June 5, 1980

December 18, 1980


December 19, 1980
    Regulatory,Action

Asbestos,  Beryllium and
Mercury Listed
Federal Register Citation.

          36 ?R 5931
Standards for Asbestos, Beryllium       36 FR 23239
Beryllium Rocket Motor Firing, and
Mercury Proposed

Final Standards for Asbestos,            38 FR 3820
Beryllium, Beryllium Rocket Motor
Firing, and Mercury

Vinyl Chloride Listed                   40 FR 39^-77

Standard for Vinyl Chloride Proposed    40 FR 59532

Final Standard for Vinyl Chloride       41 FR 46560

Benzene Listed                          42 FR 29332

Air Carcinogen Policy Proposed          44 FR 53642

Advance Notice of Proposed Rule-        44 FR 53662
making for Draft Generic Standards

Radionuclides Listed                    44 FJR 76738

Proposed Standard for Benzene --        45 FR 26660
Maleic Anhydride Plants

Arsenic Listed                          45 FR 37886

Proposed Standard for Benzene --        45 FR 33443
Sthylbenzene Plants

Proposed Standard for Benzene           45 FR 83952
Storage Vessels

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    Exhibit 7-15 summarizes the criteria used by EPA to list chemical
substances as hazardous air' pollutants ,  and the criteria relied on to set
emission standards.  The two primary criteria for listing chemicals are the
health effects resulting from exposure and evidence of significant public
exposure.  As -previously discussed, the health effects criterion is derived
from the statutory language of Section 112 of the Clean Air Act.  The
significant public exposure criterion applies only to the most recently listed
chemicals:  Radionuclides, vinyl chloride, benzene, and inorganic arsenic.
This is because EPA recently proposed an air carcinogen policy1* which
incorporates the significant public exposure criterion into EFA's regulatory
policy for listing hazardous air pollutants.

    EPA's proposed air carcinogen policy outlines how the agency will identify
carcinogenic substances and how it will 'regulate them.  The framework was
proposed as Appendix C to Part 61 of Title .40 of the Code of Federal
Regulations, and entitled, "National Emission Standards for Hazardous Air
Pollutants:  Policy and Procedures for Identifying, Assessing, and Regulating
Airborne Substances Posing a Risk of Cancer."  According to this proposed
rule, a chemical substance would be judged to present a significant
carcinogenic risk  (and hence, be listed under Section 112 as an HAP) if:
         (1)  it is believed to have a high probability of being a
              human carcinogen; and

         (2)  there is evidence of significant public exposure via
              the ambient air from emissions of one or more
              categories of stationary sources.5

    Since radionuclides and inorganic arsenic were listed as hazardous air
pollutants after this air carcinogen policy was proposed, EPA relied on the
policy to guide these two listing decisions.  Consequently, evidence of sig-
nificant public exposure was necessary before these most recently considered
chemicals were listed as KAPs .

    The specific criteria used by EPA to evaluate health impacts of the
chemicals are listed in Exhibit 7-15.  These criteria range from evidence of
adverse health effects in laboratory animals to human occupational exposure
data showing the health hazards of a chemical.

    Exhibit 7-15 also lists the criteria used by EPA to establish emission
standards for chemicals.  It is clear from the table that the Agency sometimes
relies on ambient monitoring data to set emission standards, and other times
    "See 44 FR 58642  (October 10, 1979).

    5 44 FR 5365"  (October  10, 1979), Proposed Rule as Appendix C, 40 CFR 61.

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                                      7-77
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                                   7-73
relies or. estimates of emissions,  .furthermore, when estimating emission
levels, EPA bases these estimates on different methodologies.  Both dispersion
estimates and production data estimates are used to determine the leva! of
emissions. Another consideration by EPA includes standards previously set by
other agencies.  EPA uses these other standards as guides when setting
National Emission Standards.

    The potency of the pollutant and the estimated extent of human exposure is
important particularly for deciding which specific sources or categories of
sources to regulate.  The extent that emissions can be controlled is important
to the setting of several emission standards.  The availability of control
technology and the efficiency of this control technology determine how well
emissions can be controlled.  Some emission standards are defined as the best
available control technology as opposed to a specific concentration or output
level.

    In accordance with the Clean Air Act, EPA has set emission standards to
provide an "ample margin of safety to protect the public health."  To provide
this  level of protection EPA has relied on two standard-setting methods:  One
for threshold pollutants and one for carcinogens.*  For threshold pollutants
(i.e.j pollutants with identifiable levels of exposure below which exposure
would not be expected to result in adverse health effects), EPA sets emission
standards "somewhere below the exposure level at which adverse health effects
have been found to occur in empirical research."  The standards provide an
"ample margin of safety" because they are set at levels associated with
minimal risk of adverse health effects.  Standards for threshold pollutants
are to be based solely on health effects criteria.

    Carcinogens, on the other hand, have no identifiable adverse health
effects thresholds and no exposure levels associated with zero risk of
cancer.  This poses a problem for the application of Section 112 to the
regulation of airborne carcinogens.  Two approaches were considered by EPA
must  determine the level of risk of cancer which provides "ample" protection
of the public health:

          (1)  Set emission standards for carcinogens at zero to
              eliminate the risk of cancer incidence, or

          (2)  Permit residual risks.

    Tae first approach was rejected by EPA because the Agency interpreted the
phrase "ample margin of safety" as not requiring "the complete elimination of
all risks."  Several reasons were cited for this interpretation:
     'These methods are described in EPA's proposed air carcinogen policy, --
   58659-61, October  10,  1979.

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                                   7-79
         •    If so intended,  Congress would have explicitly
              stated in Section 112 that all risks from the
              emissions of carcinogens had to be eliminated, e.g.,
              Delaney Clause of the Food and Drug Act.

         •    The consequences of zero-emission standards
              including possible widespread industry closures were
              not contemplated by Congress.

         •    The engineering tenn "margin of safety" does not
              imply a zero risk.

         «    Other public health statutes (Federal Insecticide,
              Fungicide and Rodenticide Act, Toxic Substances
              Control Act, Safe Drinking Water Act, Clean Water Act,
              and Occupational Safety and Health Act) permit
              considerations of factors other than risk in setting
              standards.

    EPA adopted the second approach for applying the phrase "ample margins of
safety" to the regulation of carcinogens.7  EPA requires sources to use the
"best available technology" to reduce cancer risks from emissions,  and
requires additional control measures only If residual risks are
"unreasonable".    To determine whether risks are "unreasonable" EPA considers
such social and economic factors as:

         •    the benefits of the activity or substance producing
              the risk,

         •    the distribution of the benefits versus the
              distribution of the risks,

         •    the availability and possible environmental risks of
              substitutes for that substance or activity, and

         •    the cost of reducing the risks further.

In short, SPA focuses on reducing health risks from carcinogens, but considers
additional factors in order to determine whether a given control level
provides "ample" protection of public health.

CHEMICAL-BY-CHEMICAL ANALYSIS

    This section of the paper examines each listed chemical in chronological
order of their listing dates.  The specific criteria used by EPA to list each
    'This approach has not yet been judicially resolved.

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                                    '-SO
chemical substance as a hazardous air pollutant are identified,  In addition,
the scission standards established by EPA, as well as the agency's rationale
for setting the standards are discussed.

     Asbestos (March 31. 19711

     The bases for EPA's selection of asbestos' as a hazardous air pollutant
were several scientific studies showing the association between exposure to
asbestos and the development of adverse health effects.  Most of these
scientific studies were based on occupational data; they related occupational
exposure to asbestos and the incidence of bronchial cancer, asbestosis, and
mesotheliomas (cancer of the membranes lining the chest and abdomen).  A few
scientific reports relied on non-occupational exposures in the neighborhood of
asbestos sources to identify asbestos as a causal factor in the development of
mesothelioma.

     Standards and Criteria.  The National Emission Standard for Asbestos
requires that there be no visible emissions to the outside air from asbestos
mills, selected manufacturing operations, the use of spray-on asbestos
materials, demolition operations, the surfacing of roadways with asbestos
tailings, the fabrication of certain structures, and insulation.  The
regulation allows owners and operators to elect an equipment-operational
standard instead of complying with the no visible emission requirement.9

     EPA chose the no visible emissions limit because the Agency saw no
satisfactory means of establishing numerical concentrations or mass emission
limits for asbestos.  EPA believed the technology to be inadequate for
measuring ambient asbestos concentrations and asbestos emissions.10  Kence,
a quantitative relationship between asbestos-caused illness and the dose which
caused those illnesses was impossible to estimate.  This uncertainty as to the
shape and character of the dose-response curve in humans, made it impossible
for EPA to determine the levels, if such levels exist, of asbestos exposure
that would not be associated with any detectable risk..  To ensure that the
emission standard would provide an "ample margin of safety to protect the
public health" from asbestos, EPA set a no visible emissions limit.

     Although there are no satisfactory quantitative ambient asbestos or
asbestos emissions data, scientific studies suggest that longer and more
      ""Asbestos' means actinolite, amosite, anthophyllite, chrysotile,
crocidolite, and tremolite" (40 ZTR 61.21(a)).

      9 40 CTR 61.22(b).

      1"Preamble to the National Emission Standard for Asbestos, 38 FR 8820
(April 6, 1973).

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                                   7-81
direct exposure to asbestos results in higher incidence of adverse health
effects.  This evidence led EPA to assume that the effects of asbestos
inhalation are cumulative.

     Available scientific evidence does not indicate that levels of asbestos
in most community air cause asbestosis.  As a result, EPA concluded that it is
not necessary to control all asbestos emissions.  To determine which sources
of asbestos emissions should be controlled, EPA relied on a 'National Academy
of Sciences report on asbestos11 which concluded:  "Continued use (of
asbestos) at minimal risk to the public requires that the major sources of
man-tnade asbestos emissions into the atmosphere be defined and
controlled."lzFollowing the recommendation in the report, EPA focused on
"major man-made sources"13 in establishing the National Emission Standard
for Asbestos.

     In the absence of quantitative emission data, a 1970' national inventory
of sources of asbestos11* was instrumental in determining which major sources
of asbestos emissions should be covered by the standard.  This inventory,
based on information obtained from production and reprocessing companies,
included production figures, estimates of control equipment efficiency, and
material balances; the inventory did not contain emission test results.

     In determining which of the major sources of asbestos emissions should be
covered by the standard, the Administrator also considered the effects other
Federal regulations would have on the emissions from such sources and the
proximity of such sources to the public.15
     11 National Academy of Sciences, Asbestos (The Need for and Feasibility
of Air Pollution Controls), Washington, 1971.

     1 * Ibid.  (emphasis added).

     13 Preamble to The National Emission Standard for Asbestos, 28 FR 3820
(April 6, 1973).

     ltt National Inventory of Sources and Emissions - Cadmium, Nickel and
Asbestos.  Report by the Department of Health, Education, and Welfare,
February 1970.

     15 Preamble to the National Emission Standard for Asbestos,  33 FR
8820. (April 6, 1973).

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                                   7-82
     Beryllium (March 31, 1971)

     In its determination that beryllium16 was a hazardous air pollutant,
EPA took into account the Atomic Energy Commission's (AEC) regulation of
beryllium in 1949 where a limit for beryllium concentrations ia community air
was set at 0.01 ug of beryllium per cubic meter of air averaged over a 30-day
period.  Epidemiclogical data was considered which indicated that the effects
of airborne beryllium materials on human health included both acute and
chronic lethal inhalation effects, as well as skin and conjunctral effects.
This data relied primarily on occupational exposures to beryllium.  The
Beryllium Registry,17 which records proven cases of beryllium-related
disease, includes 45 cases of non-occupationally incurred diseases out of 820
total listed cases of disease.  The Administrator determined that sources of
beryllium emissions into the atmosphere should be controlled in order to
protect human health from beryllium-related diseases.

     Standards and Criteria.  Retrospective studies of the concentrations of
beryllium that resulted in human cases of chronic beryllium disease from
non-o c cup at iona1 exposures concluded that the lowest concentration which
produced disease was greater than 0.01 ug/m3 and probably less than 0.10
ug/m3.

     The lack of any mechanism for the total elimination of beryllium body
burdens, resulted in EPA assuming that exposures to beryllium are additive.

     The Atomic Energy Commission's beryllium concentration limit served as a
guideline for EPA's standards.  There have been no reported cases of chronic
beryllium disease as a result of community exposure since- the implementation
of the AEC standard.  The Committee on Toxicology of the National Academy of
Sciences concluded that the AEC guideline limit represents a safe level of
exposure.  Accordingly, EPA determined that sources of beryllium emissions
into the atmosphere should be controlled to insure that ambient concentrations
of beryllium do not exceed 0.01 ug/m3 as a 30-day average.

     The beryllium standard covers all stationary sources which could result
in ambient beryllium concentrations in excess of 0.01 ug/m3.  These include:
     **"" Beryllium' means the element beryllium.  Where weights or
concentrations are specified, such weights or concentrations, apply to
beryllium only, excluding the weight or concentration of any associated
elements" (40 CFR 61.31(a)).  Associated elements are defined as loosely bound
elements in The Condensed Chemical Dictionary by Gessner G. Hawley (8th
Edition, New York:  Van Nostrand Reinhold Co.,  1971, p. 83).
      1 7
       Massachusetts General Hospital, U.S. Beryllium Case Registry, Boston.

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                                   7-83
    (a)  Extraction plants, csramic plants, foundries, incinerators,
         and propellant plants which process beryllium ore,
         beryllium, beryllium oxide, beryllium alloys,1* or
         beryllium-containing waste; and,

    (b)  Machine shops which process beryllium, beryllium oxides, or
         any alloy when such alloys contain more than 3 percent
         beryllium by weight.1'

    The National Emission Standard for Beryllium requires that emissions to
the atmosphere from stationary sources shall not exceed 10 grams of beryllium
over a 24-hour period.  This level of emissions was determined quantitatively
through dispersion estimates as the level which would protect against the
occurrence of 30-day average ambient concentrations exceeding 0.01 ug/m3.

    The beryllium standard allows those sources which have demonstrated to
EPA's satisfaction that they can meet and have met the ambient concentration
(0.01 ug/m3 for a 30-day average), to comply with the standard by use of
ambient monitoring to insure that the'0.01 ug/m3 30-day average is never
exceeded.2a

    Mercury (March 31, 1971)

    Animal (rat) data and human occupational exposures were the basis for
EPA's decision to list mercury21 as a hazardous air pollutant.  Both sources
of data indicated that exposure to metallic mercury vapors causes central
nervous system injury and kidney damage.  The animal experiments indicated a
risk of accumulation of mercury in critical systems upon'prolonged exposure
with a potential, for example, for selective brain damage.
    l"" Beryllium alloy' means any metal to which beryllium has been added
in order to increase its beryllium content and which contains mere than 0.1
percent beryllium by weight."

    1'40 CTS. 61.30(a) and 61.30(b).

    2'Separate National Emission Standards were issued for beryllium rocket
motor firing.  (40 CPU Subpart D).  Rocket-motor test sites must meet the
emission limits of 73 microgram minutes per cubic meter of air within the
limits of 10 to 60 minutes, accumulated during any 2 consecutive weeks.  If
combustion products from the firing of beryllium propellant are collected in a
closed tank, emissions from such tank shall not exceed 2 grains per hour and a
maximum of 10 grams per day.

    2l"'Mercury' means the element mercury, excluding any associatad
elements (i.e., elements which are loosely bound to mercury), and includes
mercury in particulates, vapors, aerosols, and compounds."

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                                   7-84
    Standards and Criteria.  To determine what level of mercury emissions
would provide "an ample margin of safety to protect the public health," EPA
first considered an epidemic logical evaluation of risks.  From this evidence,
EPA concluded that prolonged exposure to 100 micrograms mercury per cubic
meter of air involves a definite risk of mercury intoxication.

    EPA relied on further epidemiclogical analyses to determine the "safe"
level of exposure to mercury.  One epidemiological study investigated iseveral
exposures of mercury poisoning in Japan.  The study concluded that four
micrograms of methylmercury (which is considered to be by far the most
hazardous mercury compound) per kilogram of body weight per day would result
in the intoxication of a sensitive adult; application of a safety factor of
10* 2 yielded an acceptable exposure of about 30 micrograms per day for a
70-kilogram person.  EPA believes that this "safe" level of exposure will
protect against genetic lesions and poisoning of the fetus and children.

    Since the exposure to mercury is assumed to be additive, the EPA con-
sidered the airborne burden of mercury together with the water and food-borne
burdens.  Epidemiological studies estimate that from average diets (including
water and food) over a considerable period, mercury intakes of 10 micrograms
per day may be expected.  In order to restrict total intake to the "safe"
level of 20 aicrograms per day, the average mercury intake from air would have
to be limited to 20 micrograms per day.  After assuming that average inhala-
tion is 20 cubic meters of air per day, the air could contain an average daily
concentration of no more than 1 microgram of mercury per cubic meter.  This is
the method used by EPA to estimate the "safe" exposure level to airborne
mercury.

    The mercury standard regulates those sources which have been found to em:.t
mercury in a manner that could cause the ambient concentration to exceed the
inhalation effects liaits of one microgram per cubic meter.  The sources which
qualify are mercury ore processing facilities, mercury cell chlor-alkali
plants, sludge incineration plants, sludge drying plants, and any plants that
process wastewater treatment plant sludges.

    The permissible levels of emissions are:

         (1)  2,300 grams of mercury per day from mercury ore
              processing facilties and mercury cell chlor-alkali
              plants, and
    "Preamble to the National Emission Standard for Mercury, 38 FR 8824,
 (April 6, 1973).

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                                   7-85
         (2)  3,200 grams of mercury per 24-hour period from sludgs
              incineration plants, sludge drying plants, and any
              combination of these that process water waste
              treatment plant sludges.1'

    These levels of emissions were derived from dispersion estimates as the
levels which would protect against the violation of an average daily ambient
concentration of one tnicrogram per cubic meter.

    Vinyl Chloride (December 24, 1975)

    The EPA based its determination that vinyl chloride2" is a hazardous air
pollutant on data gathered during a 1974 EPA study to investigate whether
federal regulation of atmospheric emissions of vinyl chloride from
manufacturing facilities was needed.  The EPA study included animal bioassay
and epidemiclogical data, which strongly indicated that vinyl chloride caused
or contributed to the development of angiosarcoma, other cancers and
noncarcinogenic disorders in people with occupational exposure and in ar.inals
with experimental exposure.  The study served as the basis for EPA's
conclusion that vinyl chloride met the specifications of the definition of
"hazardous air pollutant" in Section 112 of the Clean Air Act.23

    Animal bioassay experiments showed vinyl chloride to cause cancer in both
sexes of three species of rodents by the inhalation route.  Angicsarzoma of
the liver was observed in rat, hamster, and mice bioassays.   Furthermore,
these animal studies showed a multiple cancer risk from vinyl chloride, i.e.
tumors in the liver, brain, lungs, kidneys, and mammary glands.  In addition,
bioassay studies indicated the potential of vinyl chloride to be a chemical
mutagen and teratogen.

    Epidemiological studies of occupational exposure to vinyl chloride (mainly
among workers involved directly in polyvinyl chloride production) have
strongly implicated vinyl chloride as a human chemical carcinogen which causes
tumors in many different sites.  Other manifestations in humans include
acro-osteolysis and liver dysfunction.

    There are no dose-response data, and no absolute proof of health risks at
the concentrations of vinyl chloride found in the ambient air.  As a-result,
EPA relied on "reasonable extrapolations" from the animal bioassay and
    2340 CFR 61.52(a) and (b).

    z"Vinyl chloride is not defined in the regulations.

    23 Preamble to the Proposed National Emission Standard for Vinyl
Chloride, 40 FR 59532 (December 24, 1975).

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                                   7-86
occupational findings to conclude that present ambient levels of vinyl
chloride are hazardous.26

    Also cited by EPA as rationale for designating vinyl chloride as an HAP
were:

         •    a study completed in Aprill970 by the Ad Hoc
              Committee on the Evaluation of Low Levels of
              Environmental Chemical Carcinogens entitled, "The
              Evaluation of Environmental Carcinogens";

         •    several court decisions including:  (1) Environmen-
              tal Defense Fund, Inc. v. Environmental Protection
              Agency, 510 F.2d 1292 (D.C. Cir., 1975); (2) Environ-
              mental Defense Fund, Inc. v. Ruckleshaus, 142 U.S.
              App. D.C. 74, 439 ?.2d 534 (1971); and  (3) Society of
              the Plastics Industry,.Inc. v. Occupational Safety
              and Health Administration, 509 ?.2d 1301 (1975); and

         •    OSHA's vinyl chloride standard promulgated in 1974.

    Standards and Criteria.  EPA considered the extent of human exposure to
vinyl chloride when establishing the emission standard.  Data obtained in 1974
from U.S. plants that produce or process vinyl chloride indicated that
approximately 100 million kg of vinyl chloride are emitted to the atmosphere
annually.  The majority of these emissions are from ethylene dichloride, vinyl
chloride and polyvinyl chloride plants.

    An ambient monitoring program conducted by EPA in 1974-1975 was cited as
part of the rationale for regulating vinyl chloride under the authority of
Section 112 of the Clean Air Act.  Results of this ambient monitoring program
suggest that 4.6 million people may be exposed to higher than average vinyl
chloride concentrations.  The lack of dose-response data and EPA's assumption
that no level of exposure to a chemical carcinogen is toxicologically
insignificant for humans were instrumental in ZPA's decision to reduce
exposure levels to vinyl chloride; by reducing exposure levels, EPA intended
to reduce substantially the risk that severe illness  and death would occur in
the future as a result of present and prolonged community exposure co vinyl
chloride.~*

    EPA considered regulating air emissions of vinyl  chloride under Section
109 (National Ambient Air Quality Standards) rather than under Section 112 of
    i( Ibid-' 40 12 59533  (December 24, 1975).

    Z740 fjl  59533  (December 24, 1975).

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                                   7-87
the Clean Air ACT:.  This alternative was rejected by EPA because vinyl
chloride is a localized problem and Section 109 is more appropriate for
regulating pollutants whose presence in the ambient air is ubiquitous.  Also,
the National Ambient Air Quality Standards/State Implementation Plan process
does not provide the expedited means of control to be usad for a hazardous air
pollutant.21

    To determine what level of emission control should be required, EPA
considered the economic, health and environmental impacts of a complete
prohibition of all vinyl chloride emissions, as well as the availability of
control technology.  EPA concluded that setting zero emission limits would be
neither desirable nor necessary under Section 112.  Section 112(b)(l)(3)
states:  "The Administrator shall establish any such standards at the level
which in his judgment provides an ample margin of safety to protect the public
from such hazardous air pollutants."2'  In the judgment of EPA's
Administrator, setting emission standards that require emission reduction to
the lowest level achievable by use of the best available control technology
provides "an ample margin of safety to protect the public health" from vinyl
chloride.38  This interpretation of Section 112 has never been judicially
tested.

    EPA recognizes that consideration of technology in standard setting is not
explicitly provided for under Section 112.  However, the Agency believes that
Congress did not intend to impose the costs associated with complete emission
prohibition (i.e., widespread industry closure and costs "grossly
disproportionate" to benefits) in every case involving a non-threshold
pollutant.11  According to EPA, "the purpose of the standard is to minimize
the risk to the public health by setting emission limits which will reduce
emissions to the level attainable with the best available control technology
for each emission source in ethylene dichloride, vinyl chloride, and polyvinyl
chloride plants."32  This type of emission standard will result in different
ambient air concentrations at different plants due to variations in plant size
and configurations.
     2tPreamble to the Proposed National Emission Standards for Vinyl
Chloride, 40 FR 59534 (December 24,  1974).

     2"Clean Air Act, Section  112(b)(1)(3).

     3'Preamble to the Proposed National Emission Standard for Vinyl
Chloride, 40 FR 59534 (December 24,  1975).

     31 This discussion  is  from the  Preamble  to the Proposed Standard for
Vinyl Chloride, 40 FR 59534,  (December 24, 1975).

     32 Ibid., 40 FR 59535-36.

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                                    •-88
    Two criteria were used by EPA for making technical decisions involved in
developing a standard on "the basis of "best available control technology."
These criteria were:

         (1)  The control technology must be in use in one or more
              plants in the chemical industry and be generally
              adaptable for use at the plants subject to the
              standard within the time allowed for compliance under
              Section 112, and

         (2)  Costs were considered only when they were grossly
              disproportionate to the emission reduction
              achieved.3 3

    In general, the emission standard limits the concentration of vinyl
chloride to 10 ppm in all exhaust gases discharged to the atmosphere from any
equipment used in ethylene dichloride purification, vinyl chloride formation
and/or purification, and from each polyvinyl chloride reactor.  More specific
emission standards were established for oxychiorination reactors in ethylene
dichloride plants, and certain other emission sources.

    Benzene (June 8, 1977)3U

    The Environmental Defense Fund brought the issue of listing benzene as a
hazardous air pollutant to EPA's attention.  The EDF petitioned EPA to list
benzene following the Occupational Safety and Health Administration's proposed
rule to reduce allowable workplace exposure levels of benzene.

    The decision to list benzene as an HAP was based on studies of workers in
a variety of industries and occupations; particularly influential was the
April 1977 National Institute for Occupational Safety and Health study indi-
cating high levels of leukemia in exposed workers.

    Numerous occupational studies provide evidence of human health hazards
resulting from prolonged inhalation exposure to benzene.  However, these
studies involve occupational exposure to benzene at levels higher than those
found in the ambient air.  Nevertheless, EPA concluded that "ambient exposures
[to benzene] may constitute a cancer risk and should be reduced."34  For
    33 Preamble to the Proposed National Emission Standard for Vinyl
Chloride, 40 FR 59536 (December 24, 1975).

    5U Benzene is not defined in the proposed regulations.  See listing
notice 42 FX 29332 (June 8, 1977).

    35 Ibid.

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                                   7-89
this reason, EPA decided to list benzene as a hazardous air pollutant which.
may cause or contribute to irreversible or incapacitating adverse health.
effects.

    Standards and Criteria.  As of January 1, 1981, EPA had proposed three
emission standards for sources of benzene:  (1) tnalaic anhydride plants,  (2)
ethylbenzene and styrene plants, and (3) storage vessels.38

    To determine what degree of control should be required for benzene, EPA
considered the availability of control technology, estimates of control
equipment efficiency, and the relative risk to the public.  When evaluating
the relative risk to the public, SPA noted that benzene is produced and used
in large quantities throughout the United States, and that a large number of
people are routinely exposed to measurable concentrations of benzene in the
ambient air.  The principal sources of benzene emissions are chemical
manufacturing facilities, petroleum refineries, gasoline storage and handling
facilities, coke ovens, and automobiles.  Maleic anhydride plants account for
35 percent of all stationary source emissions of benzene, and are by far  the
largest source of benzene emissions in the chemical manufacturing industry.
In addition, when EPA ranked all stationary source categories according to
estimates of cancer incidence and risk to the most exposed population, salaic
anhydride plants ranked high.37  Similar rationales support the proposed
standards for ethylbenzene plants and storage vessels.

    As of January 1, 1981, no final benzene National Emission Standard has
been promulgated.

    Radionuclides (December 27, 1979)

    Studies of human populations which conclusively show that sufficient
exposure to radiation increases the risk of many different kinds of cancer,
served as the basis for EPA's listing of radionuclides11 as a hazardous air
pollutant.  Extensive studies in experimental animals, especially rodents, and
studies of cell cultures were cited by EPA as important in their selection of
radionuclides as an HAP.  These animal and cell studies show that ionizing
    "See 45 FR 26662  (April 18, 1980), 45 FR 33448  (December 13, 1980),
and 45 FX 83952 (December 19, 1980), respectively.  A standard for fugitive
emissions was proposed on January 5, 1981, see 46 FR 1165.

    I7?reamble to the Proposed National Emission Standard for 3enzene
Emissions from Maleic Anhydride Plants, 45 FR 26662  (April 18, 1S80).

    3'"Among the radionuclides included are those defined by the Atonic
Energy Act as source material, special nuclear material, and byproduct
material" (44 FR 76738), December 27, 1979).

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                                   7--90
radiation can cause many types or mutations; extrapolations of mutation rates
calculated in these studies formed the basis for estimating the genetic
(hereditary) impact of ionizing radiation in humans.

    Since there is no conclusive evidence of the effects of very low doses of
radiation on human populations, the Agency assumed that the effects of low
doses of radiation are proportional to the dose received.  This assumption
involves the linear extrapolation of large doses to estimate the human health
impact from low dose exposure.

    As provided in EPA's recently proposed rules for regulating airborne
carcinogens, (Appendix C, 40 CFR 61), an important criteria for listing is the
evidence of significant public exposure to radionuclides because of emissions
into the atmosphere.J*  To determine the extent of human exposure to
radionuclides and the magnitude of risk, EPA compiled a list of the amount of
radionuclides released into the atmosphere for each major category of facility
known to use such materials.  The Agency estimated the radiation dose tc the
nearest individuals and to the regional population.  Using these doses, EPA
estimated the additional lifetime fatal cancer risk to individuals, and the
total number of fatal cancers induced in the surrounding population.
Recognizing that these estimates are highly uncertain, EPA concluded that the
potential risk from doses as large as those received from many of the
facilities is unnecessarily high (45 FR 76738).

    In summary, EPA determined that exposure to radionuclides increased the
risk of human cancer and genetic damage; in addition, EPA concluded that
public exposure to radionuclides was significant.  Thus, radionuclides
constitute hazardous air pollutants within the meaning of the Clean Air Act.

    Standards and Criteria.  National Emission Standards for radionuclides
have not been issued yet.  However, as provided in EPA's recently proposed
rules for regulating airborne carcinogens (44 JR 58642 (October 10, 1979)),
EPA will base all decisions on setting standards for radionuclide emissions on
detailed risk assessments and complete regulatory options analyses considering
the following factors: a detailed examination of sources of emissions of
radionuclides into air, the risk caused by these emissions, the costs and
effectiveness of emission control technologies, the benefits of the activities
causing the emissions, the relationships between who is receiving the benefits
versus who is required to accept the risks, and the possibility of using
substitutes to reduce emissions.Ul1
    "Proposed Rule Appendix C, 40 CPU 61, 44 PR 58654 (October 10, 1979).

    40"NESHAP:  Policy and Procedures for Identifying, Assessing, and
Regulating Airborne Substances Posing a Risk of Cancer," 44 FR 58642 (October
10, 1979).

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                                   7-91
    Inorganic Arsenic (June 5, 198Q)

    The decision to list inorganic arsenic"1 as a hazardous air pollutant  is
based on EPA's judgment that:

         (1)  there is a high probability that exposure to inorganic
              arsenic causes cancer in humans; and

         2)   there is significant public exposure to inorganic
              arsenic that is emitted into the air by stationary
              sources.*2

    The identification of inorganic arsenic as a probable human carcinogen is
based on animal bioassay data and epidemiological evidence.  This evidence
includes occupational exposure data causally relating inorganic arsenic and
the incidence of cancer.  Furthermore, studies of the health impact of
inorganic arsenic on communities surrounding industrial sources of arsenic
emissions show excess cancer mortalities among humans living near the sources.

    A 1977 EPA-initiated exposure study identified multiple stationary sources
of arsenic, showed that large numbers of people are exposed to localised
ambient concentrations of arsenic many times the national average
concentration, and clearly related such concentrations to identifiable
stationary sources.  This EPA-initiated exposure study was instrumental in
EPA's conclusions that inorganic arsenic causes cancer in hunacs, and there is
significant public exposure to airborne inorganic arsenic.  It should be noted
that the requirements for listing a suspected carcinogen specified in EPA's
proposed rale, "Policy and Procedures for Identifying, Assessing, and
Regulating Airborne Substances Posing a Risk of Cancer" (-44 ?S, 53642, October
10, 1979), have been met by inorganic arsenic.

    EPA believes that it is scientifically infeasible to establish safe
threshold levels for airborne carcinogens.uJ  The Agency has taken the
position that the absence of conclusive proof that substances shown to be
carcinogenic at high levels are also carcinogenic at lower exposure levels is
not relevant to a decision to list the substance as a hazardous air
    141 Inorganic arsenic, not organic arsenic,  is  listed as a hazardous air
pollutant  (45 JR 37886, June 5,  1980).  Inorganic  arsenic is not defined  in
the regulations .
       44 FR 53642  (October  10,  1979).

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                                   7-92
pollutant."*  Hence., it is assumed in this listing decision that there  is  no
safe threshold for inorganic arsenic.

    Standards and Criteria.  National Emission Standards for  inorganic
arsenic have not been proposed as of January 1, 1981.
     **  Ibid.

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                                   7-93
               MOTOR VEHICLE AND AIRCRAFT EMISSION STANDARDS-
                              REGULATORY REVIEW
MOTOR VEHICLE EMISSIONS

    As required by Section 202 of the Clean Air Act, EPA promulgated actor
vehicle emission standards for carbon monoxide, hydrocarbons,  oxides of
nitrogen, and particulate matter:  40 C?R 86, Control of Air Pollution from
New Motor Vehicles and New Motor Vehicle Engines.

    Oxides of nitrogen are defined in the regulations as "the sum of the
nitric oxide and nitrogen dioxide contained in a gas sample as if the nitric
oxide were in the form of nitrogen dioxide" OQ CTR 86.077-2).  EPA excludes
some oxides of nitrogen such as nitrous oxide in its definition of "oxides of
nitrogen".  EPA explains that the emission standard for "oxides of nitrogen"
has always been based only on measurement of nitric oxide, and nitrogen
dioxide because all other oxides are emitted in quantities too small to
measure without extreme difficulty.1  National Ambient Air Quality Standards
apply only to nitrogen dioxide.  Carbon monoxide, hydrocarbons, and
particulates are not defined in these regulations.

    As EPA has extended the Motor Vehicle Emission Standards to cover
motorcycles and other types of moving sources, the criteria for determining
the level of the standard has been the contribution of emissions from these
vehicles to ambient concentrations of carbon monoxide, hydrocarbons, nitrogen
oxides, and particulates.  If the emissions contribute substantially to the
allowable ambient air concentrations and impede the achievement of National
Ambient Air Quality Standards, then the emissions are regulated under 40 CFR
86:  Control of Air Pollution from New Motor Vehicles and New Motor Vehicle
Engines.

    In accordance with Section 202, these standards are based upon the "best
available control technology", giving appropriate consideration to "the cost
of applying such technology within the period of time available to
manufacturers and to no is e, energy, and safety factors associated with the
application of such technology."   (Emphasis added).

AIRCRAFT EMISSIONS

    The same chemicals are regulated by aircraft emission standards'as are
regulated by motor vehicle emission standards with one exception.  The
substances common to both regulations are:
     1 rord Motor Co. v. EPA, 604 F.2d 635  (D.C. Cir. 1979).

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                                   7-94
         (2)  Carbon Monoxide

         (3)  Oxides of Nitrogen

The difference between these regulations is that  particulate matter  is
regulated only by motor vehicle emission standards, while smoke  is  regulated
only by aircraft emission standards.

    Stnoke is defined in the regulations as "the matter  in exhaust emissions
which obscures the transmission of  light"  (40 CFR 87.l(a)(27)).  Oxides  of
nitrogen means "the sum of the amounts of  the nitric  oxide  and nitrogen
dioxide contained in a gas sample as if the nitric oxide were in the  form of
nitrogen dioxide" (40 CFR 87.l(a)(29)).  Carbon monoxide and hydrocarbons are
not defined in these regulations.

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                                   '-95
                 FUEL AND FUEL ADDITIVES—REGULATORY REVIEW
INTRODUCTION

     This section summarizes the Fuel and Fuel Additive regulations
promulgated under the authority of Section 211 of the Clean Air Act in order
to:

         • _  identify the chemical substances which have been
              designated for registration;

         •    examine the criteria used by EPA to regulate fuels
              and fuel additives under Section211; and

         •    review the regulations of fuels and fuel additives.

    The statutory review of Section 211 describes the two requirements for
fuels and fuel additives authorized by the Clean Air Act:  Registration and
regulation.   The regulations promulgated under Section 211, similarly, ara
twofold.  40 CFR 79 applies to the registration requirement, while 4Q CFR 80
deals with the control and/or prohibition provisions.  Exhibit 7-16 summarizes
the chronology of regulations promulgated under Section 211.

BACKGROUND

    In order to understand the various regulations and the purpose of
controlling these substances, it is useful to know some general
characteristics of fuels and fuel additives.1

    Motor vehicle fuels essentially are mixtures of various hydrocarbons,
additives, and impurities.  Exhibit 7-17 indicates the variety of hydrocarbon
compounds contained in gasoline; these hydrocarbon compounds can be grouped
into three general types:  aromatics, olefins, and paraffins.  Arcmatics and
olefins contribute to the formation of photochemical smog.  Exhibit 7-13
identifies the many common additives contained in gasoline, and their primary
functions.
            means any material which is capable of releasing energy or
power by combustion or other chemical or physical reaction."  (40 CFR 79.2(c))

    "Additive means any substance, other than one composed solely of carbon
and/or hydrogen, that is intentionally added to a fuel named in the
designation (including any added to a motor vehicle's fuel system) and that is
not intentionally removed prior to sale or use" (40 CFR 79.2(a)).

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                                   7-96
                                 EXHIBIT 7-16

                            REGULATORY CHRONOLOGY
     Date

February 23, 1972


January 10, 1973


December 6, 1973


December 12, 1974


November 7, 1975


September 28,  1976

September 12,  1979

March 7, 1380

June 2, 1980

August  IS,  1980
    Regulatory Action
Availability of Unleaded Gasoline
Regulations Proposed

Availability of Unleaded Gasoline
Regulations Promulgated
Federal Register Citation

         37 FR 3882
         38 FR 1258
Control of Lead Additives in Gasoline  38 FR 33734
Regulations Promulgated

Availability of Unleaded Gasoline      39 FR 43281
Regulations Amended

Registration of Fuels and Fuel         40 FR 52009
Additives Regulations Promulgated

Lead Phase-Down Schedule Revised       41 FR 42675

Lead Phase-Down Schedule Revised       44 FR 53144

Lead Phase-Down Schedule Revised       45 FR 14854

Lead Phase-Down Schedule Revised       45 FR 37197

Lead Phase-Down Schedule Revised       45 FR 55134

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                                   7-97
    When gasoline is burned in an internal combustion engine, carbon monoxide,
nitrogen oxides, and unburned hydrocarbons are emitted to the atmosphere.  In
response to Motor Vehicle Emission Standards promulgated under the authority
of Section 202 of the Clean Air Act, vehicles were equipped with emission
control systems to reduce the emissions of carbon monoxide, nitrogen oxides,
and hydrocarbons.  These emission control systems require the use of lead-free
gasoline, so EPA established regulations providing for the availability of
unleaded gasoline.

    In addition to the apparent need to furnish unleaded gasoline for new cars
with lead-sensitive catalytic reactors, EPA determined that, based on public
health considerations, it was necessary to reduce lead particulata emissions
from older vehicles which use leaded gasoline.2  Lead is added to gasoline
to increase the fuel octane number, and thus, prevent engine knocking.
Because the Clean Air Act does not authorize EPA to establish emission
standards for in-use vehicles, EPA promulgated regulations to phase-down the
lead additive' content of leaded gasoline, thereby reducing lead emissions.

    EPA registers fuels and additives to obtain information on fuel and
additive composition before the emission products of such naterials develop
into problems possibly requiring control or prohibition. *

    40 C7R Part 79.30 identifies the following fuels and additives to be
registered under Section 211:

         (1)  Leaded and unleaded motor vehicle gasoline (except
              motorcycle gasoline) and diesel fuel, grades 1-D and
              2-D.

         (2)  All additives produced or sold for use in motor
              vehicle gasoline and/or motor vehicle diesel fuel.

REGULATION OF FUELS AND FUEL ADDITIVES:  4Q CFS 80

    40 CTS. 80 contains the riles for the control and/or prohibition of fuels
and additives used in motor vehicles and motor vehicle engines.  The
designation of substances for regulation under this part is based on two
criteria:  The emission product of a fuel or additive:
    1 "Leaded gasoline means gasoline which is produced with the use of any
lead additive or which contains more than 0.05 grams of lead per gallon or
more than 0.005 grams of phosphorus per gallon" (40 CFR 30.2(g)).

    5 "Lead additive means any substance containing lead or lead compounds"
(40 CTS. 80.2(e)).

    4 Preamble to Registration of Fuels and Fuel Additives, 40 F7L 52009,
November 7, 1975.

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                                    r-98
         (1)  "will endanger the public health", or

         (2)  will impair "to a significant degree" the performance
              of a motor vehicle emission control device.  (40 CFR
              80.1(a))

    As discussed in the Background section, two separate regulations of fuel
and fuel additives have been promulgated in 40 CFR 80:  (1) availability of
lead-free gasoline, and (2) control of lead additives.  These regulations are
described in the next sections.

    Availability of Lead-Free Gasoline.  On February 23, 1972 (37 FR 3882),
EPA proposed regulations requiring the general availability by July 1, 1974 of
essentially lead-free gasoline.  This regulation was based on EPA's
determination that emission products of lead in motor vehicle gasolines
"impair to a significant degree the performance of emission control systems
that include catalytic converters which motor vehicle manufacturers are
developing to meet 1975-76 motor vehicle emission standards."  These emissions
control systems are intended to control nitrogen oxides, carbon monoxides, and
hydrocarbons.s

    EPA's objective in establishing these regulations was to prevent the
detriment to air quality that would occur if a significant number of catalytic
converters were damaged by using leaded gasoline in vehicles with lead-
sensitive emission control systems.

    In accordance with the Clean Air Act, Section 211(c)(2)(A),  EPA considered
all available scientific and economic data prior to this proposal.  In
addition, the Agency took into account a cost-benefit analysis comparing motor
vehicle emission control devices or systems.  Finally, EPA published a paper
entitled "Effects of Reduced Use of Lead in Gasoline on Vehicle Emissions and
Photochemical Reactivity" which indicates that requiring general availability
of lead-free gasoline will not cause the use of any other fuel or fuel
additive that will produce emissions which will endanger the public health or
welfare to the same or greater degree.


    Regulations providing for the availablity of unleaded gasoline to protect
emission control devices were promulgated on January 10, 1973 (38 FR 1258).
Because of the way unleaded gasoline is defined,* these regulations apply to
phosphorus in gasoline, as well as to  lead in gasoline.
    5 Preamble to the Proposal for Regulation of Lead and Phosphorous
Additives in Motor Vehicle "Gasoline, 37 FR 3882, February 23, 1972.

    * "Unleaded gasoline means gasoline containing not more than 0.05 grams
of lead per gallon and not more than 0.005 grams of phosphorus per gallon"
CFR 80.2(g)).

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                                   7-99
    Control of Lead Additives.  The second regulation of fuels and fuel
additives was promulgated by EPA on December 6, 1973.  This rule establishes
Federal standards limiting the use of lead additives in gasoline (23 ?R
33734), because automobile exhaust emissions of lead particles "pose a threat
to public health" (36 FR I486, January 30, 1971).

    In making the determination that lead emissions endanger public health,
EPA considered the three factors-required by SectionZll:

         (a)  all relevant medical and scientific evidence,

         (b)  other technologically or economically feasible means,
              and

         (c)  fuel and additive substitutions.

    Health Rationale.  The Agency's evaluation that there is a health basis
for reducing the use of lead in gasoline is presented in a paper entitled
"EPA's Position on the Health Implications of Airborne Lead."  The aedical and
scientific evidence cited by EPA in the determination that lead emissions pose
health risks are summarized in Exhibit
    Feasibility Criterion.  In accordance with the Clean Air Act, Section
211(c)(2)(A), EPA is required to consider whether it would be more
economically or technologically feasible to provide for the public health by
means of emission standards for new vehicles under Section 202 of the Act
(New Motor Vehicle Emission Standards) than by means of reducing gasoline lead
content.  Section 202 applies only to new vehicles; the Clean Air Act does
not permit EPA to establish emission standards for in-use vehicles.  As a
result, older vehicles would continue to use leaded gasolines.  The Agency
believed it unlikely that new motor vehicles could be equipped with emission
control devices for lead  ("lead-traps") prior to the 1976 model year.  In the
meantime, the public would be exposed to levels of airborne lead related to
adverse health effects.  Additionally, lead-traps cannot adequately protect
the lead sensitive emission control systems on new vehicles, because
lead-traps are not capable of trapping all of the lead emitted.  For these
reasons, EPA concluded that providing for the protection of public health by
means of Section 202 alone was not feasible.

    Substitutes.  Under Section 211, EPA is required to assure that the
control of lead additives will not result in the use of other gasoline
components or additives which would endanger public health to the same or
greater degree than lead  additives.  If the use of lead in gasoline is
restricted,  refiners must use greater quantities of blending stocks with high
aromatic hydrocarbon (e.g., benzene, toluene, xylene) concentrations, or
substitute anti-knock additives to increase gasoline octane levels (see
Exhibit 7-16).  EPA considered the health effects of increasing the aromatic
hydrocarbon  content of gasoline, and increasing the use of manganese additives
which function as anti-knock additives; the Agency also considered the impact

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                                   '-100
                                 EXHIBIT 7-17

                    MEDICAL AND SCIENTIFIC EVIDENCE THAT
                      LEAD EMISSIONS POSE HEALTH RISKS
(1)  The aggregate contribution of lead from all sources including food, water,
    air,  laaded paint and dust, poses a significant threat to health.


(2,)  Lead from gasoline accounts for approximately 90 percent of airborne lead.


(3)  Exposure to lead among the general population is widespread.


(i)  Preliminary data show that concentrations of airborne lead found in major
    cities can affect blood lead levels.
(5)  Lead-contaminated dust and dirt from motor vehicle exhaust are
    hypothesised to be important sources contributing to excessive lead
    exposures associated with subclinical and clinical effects in children.
(6)  Clinical symptoms resulting from high lead exposure in children are kr.own
    to be associated with permanent neurologic damage.


(7)  Physiologically significant biochemical changes, impairment of fine motor
    functions, and altered behavior have been observed to occur in children
    with excessive exposures below clinical toxicity.

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                                   7-101
of these regulations on particulars emissions.  The results of these
investigations are summarized below.

    First, implementation of these regulations is projected to result is a
five to seven percent increase in the average aromatics content of gasoline.
On the basis of evidence presented in the paper entitled "Effects of Reduced
Use of Lead in Gasoline on Vehicle Emissions and Photochemical Reacti-
vity,"7 EPA asserted that increasing the aromatic hydrocarbon content of
gasoline would not significantly impact automobile emissions reactivity and
the formation of photochemical smog.  Although aromatic hydrocarbons do
facilitate the formation of photochemical smog, increasing the aromatic
hydrocarbon content of gasoline would be offset by a decrease in the clefin
content of gasoline (olefin also facilitates the formation of photochemical
smog).  The end result would be that automobile emissions reactivity, and
thus, the formation of photochemical smog, would not be significantly impacted.

    Increasing the aromatic hydrocarbon content of gasoline would increase
poiynuclear aromatic hydrocarbon (?NA) emissions.  PSA (e.g., fluorene, nap-
thalene, pyrene) are hydrocarbon emission products which are carcinogenic (33
FR 33733, December 6, 1973) and present risks to public health.  According to
EPA estimates, implementation of these lead regulations would increase
automobile poiynuclear aromatic hydrocarbon emissions by about 2 percent and.
total PNA emissions by approximately 0.04 percent.  EPA considered this in-
crease "negligible" (38 FR 33738, December 6, 1973).  Consequently, the
Agency concluded that these regulations would not endanger public health to a
greater degree than lead emissions by increasing the aromatic hydrocarbon
content of gasoline.

    Second, EPA investigated the health effects of increasing the use of man-
ganese additives, since manganese may be used as a. partial replacement for
lead  in gasoline.  Occupational exposure studies have indicated that airborne
manganese at sufficiently high levels of exposure can cause damage to the cen-
tral nervous system and can cause manganese pneumonia.  However, the dosages
required to produce these adverse effects are several orders of magnitude
above those that would be present in the ambient air.  Hence, EPA concluded
that the use of manganese additives would not pose as significant a risk to
health as that from lead additives.

    EPA did not address the chronic effects of low-level manganese exposures
when the lead additive regulations were introduced in 1973.  However, the
Clean Air Act was amended on November 16, 1977 to include controls on man-
ganese additives to gasoline after considering the chronic effects of low-
level exposures.  Section 211(f)(2) of the amended Act prohibits the introduc-
tion  into commerce of "any gasoline which contains a concentration of man-
ganese in excess of  .0625 grams per gallon of fuel."
     73y Dr. A. ?. Altshuller, February 1972.

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                                    ;-102
    Third, ZPA determined that these regulations would have a favorable im-
pact on particulate emissions.  Because lead additives account for a major
portion of exhaust particulates,  the use of fuel without lead additives would
substantially decrease particulate emissions.   In light of the adverse health
effects resulting from particulate matter, this regulation can be viewed as
protecting the public health from particulates as well as lead emissions.

    Lead Phase-Down Schedule.  In summary, the regulations promulgated on
December 6, 1973 were designed to reduce lead usage from base 1971 by 60-65
percent.  The reduction schedule, which uses total gasoline pool averaging,
prescribes reducing the lead content in leaded gasoline over a 4-year period
to 0.5 grams per gallon by January 1, 1979.  EPA recognized that the precise
level of lead additive content associated with adverse health effects cannot
be stated with certainty.  However, the Agency established the promulgated
reduction schedule on the basis that it is "reasonable" from the standpoint of
protection of public health and from the standpoint of economic and technologi-
cal feasibility.*

    The promulgated reduction schedule is:

    January 1, 1975 ------------1.7 grams of lead per gallon
    January 1, 1976 ------------ i.^. grams of lead per gallon
    January 1, 1977 ------------1,0 grams of lead per gallon
    January 1, 1978 ------------0.8 grams of lead per gallon
    January 1, 1979 ------------0.5 grams of lead per gallon

    EPA determined that total pool averaging is the "fairest workable
mechanism for accomplishing the necessary reduction in lead usage" because it
does not discourage production of unleaded gasoline, and is the most neutral
system in its effect upon industry marketing decisions.  A quarterly averaging
period was selected because EPA found that this length of time permitted
optimum refining flexibility while also permitting the attainment of necessary
reductions in lead usage.

    Impact_of Gasoline Supply Situation.  In order to renove lead additives
from gasoline and retain the octane rating necessary to meet the octane
requirements of motor vehicle engines, refiners must produce more high octane
components as lead substitutes.  The amount of high octane components which
can be produced depends on the availability of refining facilities.  Tne ]ead
time necessary to install additional refining facilities is about 2 to 3 years
(41 7R 42675, September 28, 1976).  If refiners do not install the additional
refining facilities, they will not be able to produce enough high octane
    'Preamble to Regulation of Fuel and Fuel Additives, 38 FR 33734,
December 6, 1973.

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                                   7-103
components to produce their anticipated levels of gasoline and meet the  lead
phase-down schedule.  Alternatively, they must cut back on the production of
all gasoline in order to comply with the lead phase-down schedule.  In this
way, the lead phase-down schedule could constrain the supply of gasoline.

    To avoid a gasoline shortage, EPA promulgated an amendment to the
regulations on September 23, 1976 (41 ?R 42675) establishing a revised lead
reduction schedule.  The intent of the amendment was to achieve the desired
reduction of lead in gasoline as expeditiously as practicable for protection
of public health without causing a gasoline shortage.3  The lead phase-
down regulations were relaxed once again on September 12, 1979 (4^. ?R 431--)
as a result of the interruption of crude oil supplies from Iran ar.d the
overall tightness in gasoline supplies.  In response to an over-production o:
unleaded gasoline, EPA revoked the unleaded gasoline requirements for the
quarter beginning January 1, 1980 and ending March 31, 1980 and for the
quarter beginning April 1, 1980 and ending June 30, 1980 (45 TR 37197),  as
well as for the quarter beginning July 1, and ending September 30
(45 FR 55134).
    'Preamble to Amendment of 40 CFR 30, 41 FR i.2675, September 23, 1976.
(Emphas is added.)

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                                       M
                    COMPREHENSIVE ENVIRONMENTAL RESPONSE,
                  COMPENSATION. AND LIABILITY ACT OF 1980-
                              STATUTORY REVIEW
INTRODUCTION

    la late 1980, Congress passed the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980, commonly known as "Superfund."  The
legislation, a compromise negotiated during the lameduck session., deals with
some of the problems posed by the hazards of chemical waste and its disposal.
Because it was passed so recently, there have been no regulations promulgated
and no reported court cases dealing with it.  Therefore, this statutory review
will be brief and will be confined to the language of the statute itself and
the legislative history of the earlier versions of the bill.

    In the next section, a broad overview of the statute and its operations
will be presented.  The final section will deal with the specific issues that
are of particular concern in this review, what is a "hazardous substance" or a
"pollutant or contaminant" and what substances are taxed by Superfund.


OVERVIEW OF THE STATUTE

    The major elements of Superfund are:  certain notification requirements,
the establishment of a Hazardous Substance Response Trust Fund, authority for
removal and remedial actions, and the liability imposed.  Each of these areas
will be discussed in this section.  It should be kept in mind, however, that
since the most important area here is the substances involved (discussed in
the next section), this discussion will cover only the highlights of the
statute.

    Notification:  Superfund requires that those in charge of a vessel or
facility1-1 from which a release2-1 of the required quantity of a hazardous
substance3-1 occurred report the release to the National Response Cen-
ter.1'-'  Similarly, any persons owning, operating, or transporting hazardous
     lJBoth "vessel" and "facility" are broadly defined in Section 101 (Sec-
tion references are to the Act).  For instance, "facility" includes motor
vehicles, rolling stock, and aircraft.

     2JBroadly defined in Section 101(22).

     3JDefined in Section 101(14) and discussed in detail in the next section.

     "-Section 103(a).

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                                   8-2
substances to a. facility at which the substances have been stored,  treated,  01
disposed of without the appropriate permits are required to notify  the  Envi-
ronmental Protection Agency (EPA) of the existence of such a  facility.5j   In
addition, records on disposal facilities must generally be kept  for fifty
years.^

    Hazardous Substances Response Trust Fund:  Superfund establishes  &
Fund^-to be used by the President to respond to releases of  hazardous  sub-
stances,*-1 to reimburse response costs properly paid by other parties,  to
pay claims for injury to or destruction or loss of natural resources,SJ  and
to pay certain other expenses.10-  The Fund consists of

         (1)  moneys received from taxes levied upon crude oil
         received at a refinery in the United States or used  in  or
         exported from the United States, upon petroleum products
         entering the United States, and upon the sale of 42  enu-
         merated chemicals11-1 and

         (2)  appropriations of up to S220,000,000 over a five-year
         period.1^

    Responses:  The Act provides that the President shall revise the  National
Contingency Plan to include a section on "procedures and standards  for  re-
sponding to releases of hazardous substances, pollutants, and contamin-
ants."13-1  Response under Superfund includes both cleanup ("removal")  and
    SJSection 103(c).

    8•> Section 103(d).

    7J Section 221.

    *-See the next paragraph for more detail on  responses.

    *JNatural resources  is  fairly broadly defined, but  includes  only  those
resources controlled by  federal, state,  local, or  foreign  governments.   See
Section 101(16).

    10JSection  111.

    11JSection  211.  A discussion of how these substances  were chosen is
presented in the next section.

    IJJSection  221(b)(2).

    13-Section  105.  The definition of  "pollutant  or  contaminant"  is  dis-
cussed in the next section.

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                                   8-3
more permanent action taken to prevent additional harm ("remedial ac-
tion"). l*J  The President may respond, consistent with the National Con-
tingency Plan, whenever there is a release or a "substantial threat" of a
release of any hazardous substance or "any pollutant or contaminant which may
present an imminent and substantial danger to the public health or welfare"
and the responsible party has not properly responded and will not so re-
spond.15-

    Liability:  The liability provisions of Superfund are broad.  Owners and
operators of vessels or facilities (including facilities at which hazardous
substances were disposed of), persons who arranged for the disposal, treat-
ment, or transportation of such substances, and persons who accepted hazardous
substances for transport are liable.  Liability extends to the costs of re-
sponding (including both removal and remedial action incurred by any person
consistent with the National Contingency Plan) and damages for injury to, de-
struction of, or loss of natural resources.  The defenses available are cuita
limited.15-1

    The discussion to this point has covered the main provisions of Superfund,
namely, when and by whom notice must be given of releases and improper stor-
age, treatment, and disposal of hazardous substances; what the Hazardous Sub-
stances Response Trust Fund may be used for and how it.will be funded; when
the President is authorized to respond; and who is liable for what casts and
damages.  With this background, the more significant topics of how "hazardous
substance" and "pollutant or contaminant" are defined and how the substances
upon which fees are charged to finance the Fund were chosen can be meaning-
fully discussed.  This will be the subject of the next section of this review.

DESIGNATION CRITERIA

    This section will be divided into three parts:  (1) hazardous substance,
(2) pollutant or contaminant, and (3) substances taxed.  In each part, the
discussion will center on the statutory language and its intended meaning or
purpose as revealed in the legislative history.

    Hazardous Substance

    For the purposes of this statutory review, the definition of hazardous
substance  is the most significant provision in Superfund.  Hazardous substan-
ces are important in Superfund both because the release of certain quantities
     l*JSection 101(25) defines "response," Section 101(23), "removal," and
Section 101(24), "remedial action."

     1SJSection 104(a).

     l*-" Section 107.

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                                   8-4
of them oust be reported and because the Act authorizes the President to
respond to releases or threat of releases of such substances.17-1  Hazardous
substances are defined in Section 101(14):

         (14)  "hazardous substance" means (A) any substance desig-
         nated pursuant to section 311(b)(2)(A) of the Federal Water
         Pollution Control Act, (B) any element, compound, mixture,
         solution, or substance designated pursuant to section 102
         of this Act, (C) any hazardous waste having the character-
         istics identified under or listed pursuant to section 3001
         of the Solid Waste Disposal Act (but not including any
         waste the regulation of which under the Solid Waste Dispo-
         sal Act has been suspended by Act of Congress), (D) any
         toxic pollutant listed under section 307(a) of the Federal
         Water Pollution Control Act, (E) any hazardous air pollu-
         tant listed under secton 112 of the Clean Air Act, and (F)
         any imminently hazardous chemical substance or mixture with
         respect ot [sic] which the Administrator has taken action
         pursuant to section 7 of the Toxic Substances Control Act.

         The term does not include petroleum, including crude oil or
         any fraction thereof which is not otherwise specifically
         listed or designated as a hazardous substance under sub-
         paragraphs (A) through (F) of this paragraph, and the term
         does not include natural gas, natural gas liquids, lique-
         fied natural gas, or synthetic gas usable for fuel (or mix-
        ' tures of natural gas and such synthetic gas).

From this definition, it can be seen that there are two basic mechanisms in
the Act for designating a substance as hazardous.  The first is by the terms
of the statute itself.  Substances falling within the terms of Section
101(14)(A) and Section 101(14)(C) through-(F) are automatically hazardous.
Each of these subsections will be discussed briefly.

    Section,101(14)(A):  Under Section 311(b)(2)(A) of the Federal Water
Pollution Control Act,llJ some 2971'-1 substances have been designated as
hazardous substances.  For a detailed discussion, see the regulatory review of
the Clean Water Act.
    l7-The President is also authorized to respond to releases or threatened
releases of certain "pollutants or contaminants", as discussed in the next
part of this section.

    ltJ33 USCA 1321(b)(2)(A).

    ISJ40 CFR §116.

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                                   3-5
    Section 101(14)(C):  Pursuant to Section 3001 of the Solid Waste Disposal
Act,7^a waste is listed, as hazardous if it fulfills one of these require-
ments :

             (1)  EPA has determined that it meets one of the sta-
         tutory requirements of hazardous waste in Section 1004(5)
         of that Act;
             (2)  EPA- has determined that it can be fatal in low
         doses or is otherwise capable of causing or significantly
         contributing to an increase in serious irreversible, or  in-
         capacitating reversible, illness; or
             (3)  EPA has determined that it contains designated
         toxic constituents, unless it is not capable of posing a
         substantial present or potential hazard to human health  or
         the environment.2IJ

For more information, refer to the statutory and regulatory reviews of  the
Resource Conservation and Recovery Act.

    Section 101(14)CD):  Under Section 307(a) of the Federal Watar Pollution
Control Act,22j65 categories of chemicals have been designated as toxic
pollutants.2JJ  For a  list of these, see Exhibit 6 of the regulatory review
of the Clean Water Act.

    Section 101(14)(E):  There are presently seven chemicals that have  been
designated as hazardous  pursuant to Section 112 of the Clean Air  Act:2"-'
asbestos, beryllium, mercury, vinyl chloride, benzene, inorganic  arsenic,  and
radionuclides.**-1  For additional detail, see the regulatory ravisw of  the
Clean Air Act.

    Section 101(14)(?):  At the present time, there are no chemicals with
respect to which EPA has taken action under Section 7 of the Toxic Substances
Control Act.2'J  See the regulatory review of that Act.
     2'J42 USCA 6921.

     11JS. Rep. No. 96-848,  96th  Cong.,  2nd  Sess.  27-23  (1980).

     22J33 USCA 1317(a).

     21-140 CFR §401 (Toxic Pollutant  List).

     2kJ42 USCA 7412.

     25j40 CTS. §61.

     2SJS. Rep. No. 96-848,  96th  Cong.,  2nd  S
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                                   8-6
    In each instance, reference must be made to the relevant statute to deter-
mine what substances are hazardous under Superfund.  The legislative history
noted,  "As substances are added to these lists they would be automatically
designated as hazardous substances for purposes of" Superfund.27J  Although
not specifically mentioned here, it would be reasonable to assume that if sub-
stances are deleted from these lists, they would no longer be hazardous under
this provision of the Act.

    The other mechanism for designating substances as hazardous under Super-
fund is given in Section 101(14)(B)--substances so designated by EPA pursuant
to Section 102.  Section 102 provides:

         Sec. 102.(a)  The Administrator shall promulgate and revise
         as may be appropriate, regulations designating as hazardous
         substances, in addition to those referred to in section
         101(14) of this title, such elements, compounds, mixtures,
         solutions, and substances which, when released into the
         environment may present substantial danger to the public
         health or welfare or the environment, and shall promulgate
         regulations establishing that quantity of any hazardous
         substance the release of which shall be reported pursuant
         to section 103 of this title.  The Administrator may deter-
         mine that one single quantity shall be the reportable quan-
         tity for any hazardous substance, regardless of the medium
         into which the hazardous substance is released.

             (b)  Unless and until superseded by regulations estab-
         lishing a reportable quantity under subsection (-a) of this
         section for any hazardous substance as defined ia section
         101(14) of this title, (1) a quantity of one pound, or  (2)
         for those hazardous substances for which reportable quanti-
         ties have been established pursuant to section 311(b)(4) of
         the Federal Water Pollution Control Act, such repcrtable
         quantity, shall be deemed that quantity, the release of
         which requires notification pursuant to section 103(a) or
         (b) of this title.

In commenting upon the earlier Senate version21-1 of this section Section
3(a)(2), the Senate Committee on Environment and Public Works stated:
  .  I7JS. Rep. No. 96-848, 96th Cong., 2nd Sess. 24 (1980).   (Often referred
to hereafter as Senate Committee Report).

    2IJThis version, S. 1480, gave the powers of Section 102  to the
President rather than to the Administrator of EPA.

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                                    5-7
         Section 3(a)(2) authorizes the President to designate as
         hazardous substances those compounds, elements, mixtures,
         and solutions which may present substantial danger to pub-
         lic health and welfare and the environment.  This provision
         essentially authorizes the President to augment the exist-
         ing lists of hazardous substances derived from existing
         statutes (see, section 2(b)(13) (A), (3), (C), (D), and
         (E)).  The language of this provision has a lower threshold
         for designation than that currently in place ,in section
         3Il(b)(2) of the Clean Vater Act.  This is intended to
         afford the President broad discretion in designating sub-
         stances which may adversely affect public health or -he
         environment.19-*

    Section 102 does more than merely allow EPA to designate additional sub-
stances as hazardous.   It permits EPA to set the amount of hazardous substance
the release of which must be reported under Section 103.  Until EPA sets other
quantities, Section 102(b) establishes reportable quantities of one pound or,
where applicable, the reportable quantity established pursuant to Section
311(b)O) of the Federal Water Pollution Control Act.  The Senate Committee
Report had this to say about the setting of reportabie quantities:

         The provision intentionally omits from the requirement to
         determine 'reporting' quantities any reference to harm or
         hazard.  A single quantity is to be determined for each
         hazardous substance, and this single quantity requires
         notification upon release into any environmental medium.
         It would be virtually impossible to deternine a-single
         quantity applicable to all media while at the same time
         linking such quantity to any subjective concept of harm.

             It is essential that such quantities be relatively
         simple for those subject to notification requirements to
         understand and comply with.  Since releases in such quanti-
         ties trigger notification requirements, but do not, in and
         of themselves, give rise to other liabilities under this
         Act, the Presidents' [sic] broad discretion to select quan-
         tities will not unfairly burden those persons subject to
         the Act.

             In determining repcrtable quantities under this para-
         graph, the President may consider any factors deemed rele-
         vant to administering the reporting requirements or the
         President's other responsibilities under this Act.  Admin-
         istrative feasibility and practicality should be primary
      '-Emphasis added.  Senate Committee Report at 23.

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                                   8-8
         factors.  In addition, the President may revise such regu-
         lations from time to time if under-reporting or over-
         reporting is occurring under existing regulations.:°J

It should be noted that the Act as finally passed permits, but does not
require, establishment of a single quantity for each hazardous substance
regardless of the medium, but the reasons given by the Committee why such a
single quantity might be valuable are still valid.

    Several additional points concerning these reportable quantities should, be
made.  The first is that the wording of Section 102(a) would apparently allow
EPA to establish reportable quantities for all hazardous substances under the
statute (including those which are automatically hazardous under Superfund;,
not just for those substances designated hazardous by EPA pursuant to that
section.  An earlier Senate version seemed to allow the President to set these
quantities only for those substances he determined to be hazardous pursuant to
this section.

    Another point which may be of greater interest is that the reportable
quantity of one pound (applicable to those substances not covered by Section
311(b)(4) of the Federal Water Pollution Control Act) does not contain any
time period over which it must be released.  There is no requirement, for
instance, that the release occur in one incident or within,  say, 24 hours.
Appropriate regulations can rectify this problem, but until that time, there
is significant uncertainty in this area.31-1

    One final issue that deserves mention here is the potential differences in
reportable quantities under Superfund and other statutes involving the same
substances.  Initially, the reportable quantities established for substances
pursuant to Section 311(b)(4) of the Federal Water Pollution Control Act s.re
adopted for Superfund, but the reportable quantities of other substances are
set at one pound.  These are all subject to change by regulation.  Thus, even
for those substances affected by Section 311 of the Federal Water Pollution
Control Act, Superfund may eventually have different reportable quantities
under different statutes.  This will work against the simplicity and lack of
undue burden of which the Senate Committee on Environment and Public Works
spoke as quoted above at footnote 30.
              at 29.

    11J It should be noted that, pursuant to Section 305, Congress has the
authority to veto regulations promulgated under Superfund.  If Congress exer-
cises this authority, it could delay the date that effective regulations
eliminate this uncertainty.

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                                   8-9
    Pollutant.or Contaminant

    Hazardous substances, discussed above, are important in Superfund because
their release or threatened release triggers both the notice requirements of
Section 103 and the response authority of Section 104.  The release or threat-
ened release of a "pollutant or contaminant," however, triggers only the re-
sponse authority of Section 104.  In addition, such release or threatened
release only authorizes the President to act when it "may present an imminent
and substantial danger to the public health or welfare."32-1

    Section 104(a)(2) provides this definition of "pollutant or ccr.-aminant":

         ror the purposes of this section, 'pollutant or contami-
         nant'  shall include, but not be limited to, any element,
         substance, compound, or mixture, including disease-causing
         agents, which after release into the environment and upon
         exposure, ingestion, inhalation, or assimilation into any
         organism, either directly from the environment or indi-
         rectly by ingestion through food chains, will or may rea-
         sonably be anticipated to cause death, disease, behavioral
         abnormalities, cancer, genetic mutation, physiological mal-
         functions (including malfunctions in reproduction) or phy-
         sical deformations, in such organisms or their offspring.

         The term does not include petroleum, including crude oil
         and any fraction thereof which is not otherwise specifi-
         cally listed or designated as hazardous substances under
         section 101(14)(A) through (?) of this title, nor does it
         include natural gas, liquefied natural gas, or synthetic
         gas of pipeline quality (or mixtures of natural gas and
         such synthetic gas).

In an earlier Senate version of the bill, a similar, though not quite as
broad,35-1 definition was included as part of the definition of hazardous
substance.  As in the present Act, notification requirements generally did not
extend to releases of substances coming only under this part of the defini-
tion.  The Senate Committee Report stated:
    J2JSection 104.

    JJJIt was not quite as broad because it did not use the phrase "shall
include, but not be limited to.  .  .  ."  S, 1430, Section 2(12)(3).

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                                   8-10
         This generic definition is included because hazardous sub-
         stances characteristically are not included on a governmen-
         tal list until after they have demonstrated their danger by
         killing or injuring people or causing significant environ-
         mental damages.   The actual listing of a substance lags
         behind release and exposure by years and sometimes
         decades.  This happens even though the persons responsible
         for manufacturing or handling the substances usually know,
         either through experience or scientific studies, of the
         substance's dangerous propensities.

             Examples of substances added to lists only after they
         caused harm, even though there was reason to know of their
         dangerous qualities earlier, include asbestos, kepone, and
         organic mercury.  Some substances have not been included on
         one of the relevant lists even after they have, in fact,
         caused grievous injuries.
             Subparagraph (G) describes substances which are harm-
         ful to humans and includes them within the scope of S. 1480
         whether they are included on a regulatory list or not.  The
         definition was intentionally made broad in order to assure.
         that any substance or agent which causes disease in humans,
         whether it is an element, chemical, pathogen, or mixture,
         is included.  Of course, if a substance is determined as
         'hazardous' only by virtue of section 2(b)(13)(G)--that is,
         it meets the subparagraph (G) definition, but is not a
         designated hazardous substance under subparagraphs (A)
         through (T)--the consequences under this bill are less than
         if it has been on one of the lists.JfcJ

The present definition of pollutant or contaminant would seem to serve the
same purpose.

Substances Taxed

    Superfund is primarily financed through fees paid on the sale or use  of  a
number of chemicals.  The chemicals themselves ae not necessarily hazardous,
but somewhere in the chain of production, sale, or use of these chemicals, a
hazardous substance is generated.  The Senate-Committee Report said this  about
why this fee system and these chemicals were chosen:
    JfcJS. Rep. No. 96-848, 96th Cong., 2nd Sess. 29, 30  (1980).

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                                   8-11
         Financing the  Fund  primarily from fees  paid by industry is
         the  most  equitable  and rational method  of broadly spreading
         the  costs of past,  present  and future releases of hazardous
         substances among all  those  industrial sectors  and consumers
         who  benefit from such substances.   The  concept of a fund
         financed  largely by appropriations was  not adopted.  A
         largely appropriated  fund establishes a precedent adverse
         to the  public  interest--it  tells polluters that the longer
         it takes  for problems to appear, the less responsible they
         are  for paying the  consequences of their actions, regard-
         less of the severity  of the impacts.  Too often the general
         taxpayer  is asked to  pick up the bill for problems he did
         not  create; when costs can  be more appropriately allocated
         to specific economic  sectors and consumers,  such costs
         should  not be  added to the  public debt.

             The fee system  was adopted affar extensive investiga-
         tion of alternatives.   This fee system  provides the best
         balance of equity,  rapid implementation, legal defensibil-
         ity, administrative simplicity, and a minimum  of any ad-
         verse economic and  environmental impacts.  The fees are
         imposed at the beginning of the commercial chain of produc-
         tion, distribution, consumption, and disposal  of hazardous
         substances. The fee  is assessed on substances which are
         either  hazardous themselves or are the  basic building
         blocks  (primary petrochemicals, inorganic raw  materials and
         petroleum oil) used to make almost all  major hazardous sub-
         stances .

             3y  collecting a fee at  the beginning of the producton"
         cycle,  this fee system uses the efficiency of  the market-
         place to  automatically and  broadly distribute  the risks
         associated with chemicals through fees  on all  industrial
         sectors in the chain  of production, transportation, use and
         disposal  of hazardous substances.   This is a more effective
         mechanism than distributing risks through the  rules and
         regulations of a Federal agency and it  is fully consistent
         with the  spirit of  regulatory reform.

             The 463JJ  substances subject to the fee meet at least
         two  or  more of the  following criteria:   (i)  they are
         inherently hazardous  or hazardous in a  number  of forms
    JSJIn the final legislation,  42 chemicals (almost all of which were on
che Senate list of 46)  plus crude oil and petroleum products ara zaxed.

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                               8-12
     (interned.!ares  or final products),  (ii)  they are hazardous
     in some  form if released,  (iii)  hazardous wastes are gene-
     rated in producing them or their intermediate or final
     products, (iv)  they are capable  in  one or more forms of
     increasing  the  hazardous potential  of other substances; and.
     (v)  they are produced in significant quantities.  A fee may
     attach to a- product even though  it  is itself environmen-
     tally benign, since earlier in the  chain of production,
     distribution, consumption  and disposal it used a hazardous
     substance or later in the  chain  it  will  be used to generate
     a hazardous substance.jej
1SJS.  Rep.  No.  96-848, 96th Cong., 2nd Sess. 72-73 (1980)

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                                                    7-29
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