Table of Contents
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Front Matter	i-xviii
Executive Summary	1-2	(skim)
USE OF THE MAXIMUM TOLERATED DOSE IN ANIMAL BIOASSAYS FOR CARCINOGENICITY	3-8	(skim)
THE TWO-STAGE MODEL OF CARCINOGENESIS	9-9	(skim)
A PARADIGM FOR ECOLOGIC RISK ASSESSMENT	10-12	(skim)
Issues In Risk Assessment Use Of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity	13-14	(skim)
BACKGROUND	15-17	(skim)
SCOPE OF REPORT	18-20	(skim)
DEFINITIONS AND BACKGROUND	21-23	(skim)
CORRELATIONS	24-32	(skim)
RELATIONSHIP BETWEEN TOXICITY AND CARCINOGENICITY OBSERVED AT MTD	33-42	(skim)
QUALITATIVE INFORMATION	43-48	(skim)
QUANTITATIVE INFORMATION	49-52	(skim)
OPTION 1	53-53	(skim)
OPTION 2	54-54	(skim)
OPTION 3	55-56	(skim)
Option 4A	57-58	(skim)
Option 4B	59-60	(skim)
5 Conclusions and Recommendations	61-66	(skim)
REFERENCES	67-78	(skim)
BACKGROUND	79-79	(skim)
DEFINING AND DETERMINING THE MTD	80-90	(skim)
Appendix B Organizing Subcommittee	91-92	(skim)
Appendix C Federal Liaison Group	93-94	(skim)
Appendix D Workshop Program	95-96	(skim)
Appendix E Workshop Attendees	97-110	(skim)
1. INTRODUCTION	111-112	(skim)
2.1 Measures of Carcinogenic Potency	113-115	(skim)
2.2 Carcinogenic Potency Database (CPDB)	116-116	(skim)
2.3 Variation in Carcinogen Potency	117-118	(skim)
2.4 Classification of Carcinogens	119-120	(skim)
3.1 Empirical Correlations	121-124	(skim)
3.2 Range of Possible TD50 Values	125-125	(skim)
3.3 Analytical Correlations	126-127	(skim)
3.4 Model Dependency	128-129	(skim)
3.5 Genotoxic vs. Nongenotoxic Carcinogens	130-130	(skim)
4.1 Predictions Based on the MDT	131-131	(skim)
4.2 Predictions Based on Mutagenicity and Acute Toxicity	132-134	(skim)
5.1 Correlation Between Upper Bounds On the Low Dose Slope and MTD	135-135	(skim)
5.2 Correlation Between q1* and the TD50	136-138	(skim)
5.3. Preliminary Estimate of Risk	139-139	(skim)
6. INTERSPECIES EXTRAPOLATION	140-140	(skim)
6.1 Extrapolation from Rats to Mice	141-143	(skim)
6.2 Extrapolation from Rodents to Humans	144-145	(skim)
7. CONCLUSIONS	146-148	(skim)
8. ACKNOWLEDGEMENTS	149-149	(skim)
9. REFERENCES	150-159	(skim)
ANNEX A: MAXIMUM LIKELIHOOD METHODS FOR FITTING THE WEIBULL MODEL	160-161	(skim)
ANNEX B. SHRINKAGE ESTIMATORS OF THE DISTRIBUTION OF CARCINOGENIC POTENCY	162-163	(skim)
ANNEX C: ADJUSTMENT OF POTENCY VALUES FOR LESS THAN LIFETIME EXPOSURE	164-165	(skim)
ANNEX D: CORRELATION BETWEEN TD50 AND MTD	166-168	(skim)
ANNEX E: CORRELATION BETWEEN TD50S FOR RATS AND MICE	169-172	(skim)
Appendix G Informal Search for ''Supercarcinogens"	173-174	(skim)
CRITERIA AND CANDIDATE CHEMICALS	175-176	(skim)
DATA	177-180	(skim)
RESULTS	181-181	(skim)
DISCUSSION	182-184	(skim)
Issues in Risk Assessment The Two-Stage Model Of Carcinogenesis	185-186	(skim)
INTRODUCTION	187-187	(skim)
BIOLOGIC CONSIDERATIONS	188-189	(skim)
THE TWO-STAGE MODEL	190-195	(skim)
APPLICATIONS OF THE TWO-STAGE MODEL TO ANIMAL DATA	196-211	(skim)
Data Needs	212-212	(skim)
Criteria for Adoption	213-213	(skim)
Prospects	214-214	(skim)
CONCLUSIONS AND RECOMMENDATIONS	215-216	(skim)
REFERENCES	217-222	(skim)
BIOLOGICAL FACTORS IN TWO-STAGE MODELS	223-225	(skim)
TWO-STAGE MODEL OF CLONAL EXPANSION	226-227	(skim)
APPLICATION OF THE TWO-STAGE MODEL TO ANIMAL DATA	228-232	(skim)
Appendix B Workshop Program	233-234	(skim)
Appendix C Workshop Federal Liaison Group	235-236	(skim)
TOPIC GROUP MEMBERS	237-238	(skim)
Appendix E Workshop Organizing Task Group	239-240	(skim)
Isuees In Risk Assessment A Paradigm for Ecological Risk Assessment	241-242	(skim)
1 Introduction	243-246	(skim)
2 Scope of Ecological Risk Assessment	247-248	(skim)
COMPONENTS OF THE 1983 FRAMEWORK	249-250	(skim)
CONSISTENCY OF CASE STUDIES WITH THE 1983 FRAMEWORK	251-253	(skim)
INTEGRATION OF ECOLOGICAL RISK INTO THE 1983 FRAMEWORK	254-254	(skim)
DEFINITION OF FRAMEWORK COMPONENTS FOR ECOLOGICAL RISK ASSESSMENT	255-258	(skim)
EXTRAPOLATION ACROSS SCALES	259-260	(skim)
QUANTIFICATION OF UNCERTAINTY	261-261	(skim)
VALIDATION OF PREDICTIVE TOOLS	262-262	(skim)
VALUATION	263-264	(skim)
5 Conclusions	265-266	(skim)
6 Recommendations	267-268	(skim)
REFERENCES	269-272	(skim)
Appendix A Workshop Participants	273-278	(skim)
Appendix B Workshop Organizing Subcommittee and Federal Liaison Group	279-280	(skim)
Appendix C Workshop Introduction	281-282	(skim)
TERRY F. YOSIE BUILDING ECOLOGICAL RISK ASSESSMENT AS A POLICY TOOL	283-285	(skim)
D. WARNER NORTH: RELATIONSHIP OF WORKSHOP TO NRC'S 1983 RED BOOK REPORT	286-288	(skim)
MICHAEL SLIMAK: U.S. ENVIRONMENTAL PROTECTION AGENCY ACTIVITIES IN ECOLOGICAL RISK ASSESSMENT	289-292	(skim)
CASE STUDY 1: TRIBUTYLTIN RISK MANAGEMENT IN THE UNITED STATES	293-293	(skim)
Discussion	294-294	(skim)
CASE STUDY 2: ECOLOGICAL RISK ASSESSMENT FOR TERRESTRIAL WILDLIFE EXPOSED TO AGRICULTURAL CHEMICALS	295-296	(skim)
CASE STUDY 3A: MODELS OF TOXIC CHEMICALS IN THE GREAT LAKES: STRUCTURE, APPLICATIONS, AND UNCERTAINTY ANALYSIS	297-298	(skim)
CASE STUDY 3B: ECOLOGICAL RISK ASSESSMENT OF TCDD AND TCDF	299-299	(skim)
Discussion	300-300	(skim)
CASE STUDY 4: RISK ASSESSMENT METHODS IN ANIMAL POPULATIONS: THE NORTHERN SPOTTED OWL AS AN EXAMPLE	301-301	(skim)
Discussion	302-302	(skim)
CASE STUDY 5: ECOLOGICAL BENEFITS AND RISKS ASSOCIATED WITH THE INTRODUCTION OF EXOTIC SPECIES FOR BIOLOGICAL CONTROL OF A...	303-303	(skim)
Discussion	304-304	(skim)
CASE STUDY 1: UNCERTAINTY AND RISK IN AN EXPLOITED ECOSYSTEM: A CASE STUDY OF GEORGES BANK	305-306	(skim)
Discussion	307-308	(skim)
Generic Issues	309-309	(skim)
Analysis of Case Studies	310-310	(skim)
DOSE-RESPONSE ASSESSMENT	311-311	(skim)
Selection of End Points	312-312	(skim)
Consideration of Nonlinearities And Discontinuities	313-313	(skim)
Understanding the Stressor	314-314	(skim)
Additions to the 1983 Paradigm Needed for Ecological Risk Assessment	315-315	(skim)
Modeling Needs for Stress-Response Relationships	316-316	(skim)
Methods of Measuring Stressors for Ecological Exposure Assessment	317-317	(skim)
Definition of Risk Characterization	318-318	(skim)
Components of Risk Characterization	319-319	(skim)
Organization and Presentation	320-320	(skim)
Differences from and Similarities To the 1983 Report	321-321	(skim)
Application to the Case Studies	322-323	(skim)
Agricultural Chemicals	324-324	(skim)
Northern Spotted Owl	325-325	(skim)
General Discussion: Models and Risk Assessment	326-326	(skim)
Uncertainties Identified In the Case Studies	327-327	(skim)
Implications of Uncertainty for Ecological Risk Assessment	328-328	(skim)
VALUATION	329-330	(skim)
Risk Assessment Has Many Uses	331-332	(skim)
Different Risk Assessment Methods Are Suited to Different Risk Assessment Needs	333-333	(skim)
Risk Assessors and Risk Managers Need to Communicate	334-334	(skim)
Credibility is Crucial	335-336	(skim)
Appendix G Contemplations on Ecological Risk Assessment	337-342	(skim)
Appendix H Workshop Summary	343-346	(skim)
Appendix I References for Appendixes	347-350	(skim)
Appendix J Workshop Program	351-356	(skim)

Description

The scientific basis, inference assumptions, regulatory uses, and research needs in risk assessment are considered in this two-part volume.
The first part, Use of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity, focuses on whether the maximum tolerated dose should continue to be used in carcinogenesis bioassays. The committee considers several options for modifying current bioassay procedures.
The second part, Two-Stage Models of Carcinogenesis, stems from efforts to identify improved means of cancer risk assessment that have resulted in the development of a mathematical dose-response model based on a paradigm for the biologic phenomena thought to be associated with carcinogenesis.

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Issues in Risk Assessment

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