Texas Commission on Environmental Quality

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1 Roberta L. Grant, Susan L. Santos, Mike L. Dourson, Stephanie Shirley, Neeraja K. Erraguntla, R. Jeffrey Lewis, and Nancy B. Beck Society of Toxicology, March 22-26, 2015 San Diego, CA Texas Commission on Environmental Quality

2 Focused on US Environmental Protection Agency s Integrated Risk Information System (IRIS) as an example Considered experiences in other programs with varied mandates Used specific case studies to explore diverse approaches (including some very basic ideas) Work is continuing to develop implementable approaches showing how information can be presented differently to improve the consideration and use of uncertainty information by risk managers *American Chemistry Council s Center for the Advancement of Risk Assessment Science and Policy 2

3 The Workshop examined four approaches: 1. Comparing Values to Other Relevant Peer-Reviewed Numbers 2. Unpacking Toxicity Assessments to Understand and Improve Confidence Focus of this talk 3. Presenting Toxicological Information Visually in the Context of Alternative Values, Exposure Levels, and Biomonitoring Equivalents 4. Improving Transparency in Dose-Response Decision Making *American Chemistry Council s Center for the Advancement of Risk Assessment Science and Policy 3

4 Completeness of Database Study Quality Reference Concentration (RfC)/ Reference Dose (RfD) * USEPA (1994) Methods for Derivation of Inhalation Reference Concentration and Application of Inhalation Dosimetry 4

5 Many steps in toxicity assessment the major steps are referred to as elements 8 major elements of a toxicity assessment and 3 confirmatory elements assessed for the purposes of our example, each element is treated as being equally important how confident are we that the value is likely to be accurate/precise/predictive

6 Accuracy: degree of closeness of the measurements to that quantities actual (true) value Precision: the degree to which repeated measurements under unchanged conditions show the same value Predictive: is there a balance between being protective and reasonably accurate. 6

7 Used clear criteria to judge confidence and implement scaling (numerical or descriptive values) 1 = low confidence; 5= high confidence Audience = risk assessor help explain approach and confidence to a risk manager/decision maker 7

8 Non-Cancer Toxicity Assessment Elements Element Database Completeness Systematic Review Description for High Confidence Database included investigations of a comprehensive array of non-cancer toxicity endpoints, established from studies of chronic duration in various mammalian species (refer to EPA 1994) A systematic approach was used to identify studies, evaluate their quality and integrate them. Key Study Quality The key study(ies) are well-conducted and can be used without restrictions. Critical Effect Relevance of Critical Effect Point of Departure (POD) Human Equivalent POD The database is sufficient to identify the effect occurring at early time points (i.e. critical effect). This should protect against all other adverse effects. MOA information, if available, helps to determine if the earliest critical effect has been identified. The critical effect is known to be related to human findings. If only animal studies are available, MOA information, if available, helps to determine if the critical effect is relevant to humans. Dose response is well understood and NOAEL and LOAEL are identified. Ideally, BMC/BMD modeling was performed with small differences between BMD and BMDL. Human data are available or human equivalent dose/concentration is known from PBPK or similar model. Sensitive Populations Human data on sensitive subpopulations are available or PBPK or similar model is available to account for TK/TD differences between general and sensitive populations. 8

9 Cancer Toxicity Assessment Elements Element Description for High Confidence Carcinogenic Potential Systematic Review Using a weight of evidence approach, adequate data exists to classify the chemical into EPA/IARC categories (e.g., not carcinogenic, possibly carcinogenic, known carcinogen, etc.). A systematic approach was used to identify studies, evaluate their quality and integrate them. Key Study Quality Relevance of Critical Effect Point of Departure Human Equivalent POD Low Dose Extrapolation Sensitive Populations The key study(s) are well-conducted and can be used without restrictions. The tumor type/site is known to be related (or may be related) to human findings. If only animal studies are available, MOA information, if available, helps to determine if the critical effect is relevant to humans. Dose response is well understood. Ideally, BMC/BMD modeling was performed with small differences between BMD and BMDL. Human data are available or human equivalent dose/concentration is known from PBPK or similar model. A biologically based model or PBPK model is available and MOA understanding leads to extrapolation to lower doses with confidence. Human data on sensitive subpopulations are available or PBPK or similar model available to account for TK/TD differences between general and sensitive populations. If the MOA is mutagenic, then age-dependent adjustment factors were applied. 9

10 Elements for a Confirmation of Toxicity Assessment Element Description for High Confidence Peer Review An external independent peer review was conducted including opportunities for public comment, written peer review report, and the Agency has responded appropriately to peer review and public comments. Validation Risk Value Comparison The Agency has evaluated whether the final toxicity values are realistic and plausible based on available information. Relevant values from high quality, peer reviewed sources, are within three-fold of each other. 10

11 Validation or Reality Check In some cases, the aggregate impact of all risk assessment decisions involved in a toxicity assessment results in a toxicity value that is overly conservative and unrealistic. Example: applying UFs in multiple areas, and then multiplying them together, may compound the conservatism as the upper bounds on each of the factors is used in the calculation 11

12 Toxicity Assessment Elements that Were Not Considered Mode-of Action RfC/RfD Confidence Uncertainty Factors 12

13 Confidence Scoring: Example Hazard Identification: Quality of Key Study(ies) Confidence scale and basis for scoring Implication References 1 = Low: chosen study may have deficiencies, but is still considered useful. 2-3 = Medium: chosen study is reasonably well done and can be used with some restrictions; extrapolation seems reasonable based on findings with other chemicals 4-5 = High: chosen study is well done and can be used without restriction Klimisch scores for evaluating quality of toxicology studies have international support; other scales have also been widely used. A scoring method consistent with Klimisch scores for assessing quality of human studies also exists, along with other scales. Studies with Klimish scores associated with high confidence can be used with little or no restriction. Potential tools: H.J. Klimisch, M. Andreae and U. Tillmann A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data. Regulatory Toxicology and Pharmacology Vol 25 pp 1-5 EPA s OPP Core grades (guideline, minimum, supplementary, invalid) EPA IRIS principal study confidence scoring (high, medium or low) Bevan and Strother, 2012 Money et al., 2013 Systematic Review tool quality assessment components (e.g. NTP OHAT approach, Rooney, 2014) Similar tables describing basis for confidence scoring available for other Major Elements described earlier e.g., database completeness, systematic review, critical effect, etc. 13

14 Confidence Scoring: Example - Dose-Response Assessment: Point of Departure (POD) a Confidence scale and basis for scoring 1 = Low: many uncertainties exist in the POD; only a free-standing NOAEL or LOAEL identified; few dose groups; BMD modeling not possible 2-3 = Medium: some uncertainty exists in identified POD, NOAEL or LOAEL identified, but few dose groups; BMD modeling was conducted; difference between BMD and BMDL is large 4-5 = High: dose response and basis for POD are well understood: NOAEL and LOAEL identified; multiple dose groups, BMD modeling conducted; difference between BMD and BMDL is small (approximately 2-fold or less) Implication When BMC/BMD modeling can be performed, the entire dose-response curve is used to determine the POD. Such determination improves the basis of risk management decisions. References Many references here (e.g., IPCS, 2005; EPA, 2002; EPA, 2012) a slope of the dose-response curve is critical information if the RfC or RfD is exceeded. A steep slope increases the importance of the exposure assessment. Similar tables describing basis for confidence scoring available for other Major Elements described earlier e.g., database completeness, systematic review, critical effect, etc. 14

15 Confidence Scoring Results for Inhalation RfC for Carbon Tetrachloride (CCl4) Major Elements Peer Review +++ Validation - Confirmation Elements Toxicity Value Comparison - 15

16 Confidence Scoring Results for Inhalation Reference Value (ReV) for 4-vinylcyclohexene (4-VCH) Database Completeness Systematic Review Key Study Quality Major Elements Critical Effect Relevance of Critical Effect Point of Departure (POD) Human Equivalent POD Sensitive Populations Peer Review ++ Validation - Confirmation Elements Toxicity Value Comparison - 16

17 Confidence Scoring for RfC for CCl4 Confidence Scoring for ReV for 4-VCH 17

18 Confidence Scoring for RfC for CCl4 Element Score Basis Database Completeness 3 Medium Developmental study in different species and multigeneration study lacking (confidence from EPA (2010) was medium) Systematic Review 1 Low Key Study Quality 5 High Critical Effect 4 High Relevance of Critical Effect 5 High Point of Departure (POD) 5 High Human Equivalent POD 4 High Sensitive Populations 3 Medium Peer Review +++ High At the time of this assessment, IRIS did not employ a systematic procedure for data gathering, analysis and internal review The chosen study is well done and can be used without restriction (confidence from EPA (2010) was high) Studies are sufficient to determine the critical effect with confidence; fatty change in liver is moderate severity The critical effect of liver toxicity is appropriate to humans. Extrapolation seems reasonable based on findings with humans and other experimental animal species. Critical effect matches human experience A lower limit on the BMD was used as the POD. Multiple dose groups HEC and duration adjustments were derived using a PBPK model Available life stage information does not suggest increased childhood susceptibility The external peer review seemed adequate and EPA appeared to take comments into consideration Validation - Not conducted Risk Value Comparison - Not conducted 18

19 Confidence Scoring for ReV for 4-VCH Element Score Basis Database Completeness 3 Medium Systematic Review 1 Low A subchronic inhalation study was available in two species. Inhalation developmental study and multigeneration inhalation study lacking. An oral two generation reproductive/developmental study in mice showed no effects on reproductive function (confidence from TCEQ (2011) was medium). At the time of this assessment, TCEQ did not employ a systematic procedure for data gathering, analysis and internal review. Key Study Quality 3 Medium Critical Effect 2 Medium Relevance of Critical Effect 1 Low Point of Departure (POD) 2 Medium Human Equivalent (POD) 3 Medium Sensitive Populations 1 Low Peer Review ++ Medium The chosen study was conducted using GLP in rats and mice, although only10 animals/sex were evaluated. (confidence from TCEQ (2011) was medium). Studies are sufficient to determine the critical effect with confidence. Three concentrations were tested and multiple endpoints evaluated. The following critical effects occurred at the highest concentration: ovarian atrophy and mortality (severe effects) and lethargy/ tremor (moderate effects). Mice are sensitive for ovarian atrophy because they produce more reactive metabolite than humans. However, since it is possible that humans produce the reactive metabolite, a default assumption was made that ovarian atrophy may occur in humans. The MOA for tremor/lethargy is not known, so it was assumed these effects were relevant to humans. BMC modeling was not conducted because adverse effects only occurred at the highest concentration. A NOAEL and a LOAEL were identified. Default duration adjustments and animal-to-human adjustments were conducted. Available life stage information was not available to indicate sensitive populations exist. Peer input, a 90-day public comment period, and comments were addressed. Validation - Data are not available to conduct a reality check. Risk Value Comparison - Chronic inhalation values from other sources were not available. 19

20 Presentation of risk assessment results in clear and concise manner is challenging Risk Managers must apply this information to make decision No right way to communicate this type of information Different approaches may appeal to different people Consideration should be given to testing (e.g. focus groups) before adopting or adapting approaches 20

21 Method presented treats each element as equally important But element weighting could be done Many elements interrelated (e.g., mode of action information important to identification of critical effect and human relevance) The working groups welcome input and feedback on the approaches 21

22 Roberta L. Grant, Neeraja K. Erranguntla, and Stephanie Shirley (Texas Commission on Environmental Quality (TCEQ)) Susan L. Santos (Focus Group Consulting & Rutgers University) Mike L. Dourson (Toxicology Excellence for Risk Assessment (TERA)) R. Jeffery Lewis (Exxon Mobile Biomedical Services) Nancy B. Beck (American Chemistry Council) 22

23 Thank you!

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