Document ID: EPA-HQ-OPPT-2022-0918-0022
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2023-04-20T04:00Z

AGENDA
                                       
                  U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA)
                SCIENCE ADVISORY COMMITTEE ON CHEMICALS (SACC)
                            VIRTUAL PUBLIC MEETING
                                May 8-11, 2023
                                       
              SACC WEB SITE: http://www.epa.gov/tsca-peer-review
                                       
                 DOCKET NUMBER: EPA - HQ - OPPT - 2022 - 0918 
                                       
                  MEETING LOCATION: Online via Zoom Platform
                          (Register here  to attend)
                                       
[Please note that all times are Eastern Standard Time (EST) and are approximate as noted below. Agency speakers may change based on availability.]
                                       
                                 MEETING TITLE
                                       
Draft Proposed Principles of Cumulative Risk Assessment (CRA) under the Toxic Substances Control Act and a Draft Proposed Approach for CRA of High-Priority Phthalates and a Manufacturer-Requested Phthalate.
                                       
                                        Day 1
                                 Monday May 8, 2023
                                          
                                        Day 1
                                 Monday May 8, 2023
                                          

10:00 A.M. 	Opening of Meeting  -  Alaa Kamel, Ph.D., Designated Federal Official, Office of Program Support (OPS), Office of Chemical Safety and Pollution Prevention (OCSPP), EPA 

10:10 A.M. 	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, Science Advisory Committee on Chemicals (SACC) 

10:20 A.M.	Introduction and Welcome  -  Denise Keehner, Director, Office of Pollution Prevention and Toxics (OPPT), OCSPP, EPA 

10:30 A.M. 	Welcome and Introductory Comments  -  Michal Freedhoff, Ph.D., Assistant Administrator, OCSPP, EPA

10:40 A.M. 	OPPT Technical Presentation #1  -  Draft Proposed Principles of Cumulative Risk Assessment Under the Toxic Substances Control Act  -  Anthony Luz and Maiko Arashiro, OPPT, OCSPP, EPA

11:40 P.M.	OPPT Technical Presentation #2 - Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and Manufacturer-Requested Phthalates Under the Toxic Substances Control Act - Anthony Luz, OPPT, OCSPP, EPA

1:00 P.M. 	Lunch Break

2:00 P.M.	OPPT Technical Presentation #3 - Draft Proposed Approach for CRA of High-Priority and Manufacturer Requested Phthalates Under TSCA  -  Maiko Arashiro, OPPT, OCSPP, EPA

3:15 P.M.	Public Oral Comments

5:00 P.M.	Adjourn
  
                                         Day 2
                                  Tuesday May 9, 2023
                                       
                                         Day 2
                                  Tuesday May 9, 2023
                                       

10:00 A.M. 	Opening of Meeting  -  Alaa Kamel, Ph.D., Designated Federal Official, OPS, OCSPP, EPA

10:05 P.M. 	Panel Members: Follow-Up on Previous Day  -  Daniel Schlenk, Ph.D., Chair Science Advisory Committee on Chemicals (SACC) 

10:15 A.M. 	Charge Question 1: 
 
EPA's Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act (Draft Proposed Principles Document) provides an overview of TSCA and cumulative risk assessment (CRA) within the regulatory requirements of TSCA. In the development of this document, EPA relied substantially on existing work by EPA's Risk Assessment Forum, EPA's Office of Pesticide Programs, the Organisation for Economic Co-operation and Development, the European Commission, and the World Health Organization and International Programme on Chemical Safety (see list in Section 3 of the draft report). Please identify any additional key methodology documents that the panel is aware of that could inform EPA's approach to CRA under TSCA. 

10:45 A.M.		Charge Question 2:

As described in Section 3.4 of the Draft Proposed Principles Document, EPA is proposing to establish a cumulative chemical group for purposes of CRA using a weight of evidence approach that characterizes the strengths and uncertainties of the evidence of toxicological similarity and potential co-exposure for each chemical substance in the group. Please comment on the appropriateness of this approach, including on the strengths and uncertainties. If appropriate, please provide additional considerations for existing lines of evidence that EPA may consider. 
 
11:30 P.M. 	Charge Question 3:

Several additivity approaches can be used to evaluate multiple chemical substances for cumulative risk, including dose addition, response addition, and integrated addition (Section 3.5). Consistent with EPA guidance, the Agency plans to rely upon a default assumption of dose addition when conducting CRAs for toxicologically similar chemical substances under TSCA -- unless empirical evidence supports application of another approach. Please comment on this proposed approach, including associated strengths and uncertainties

12:15 P.M.	Charge Question 4: 
                                        
Please comment on the overall clarity of EPA's Draft Proposed Principles Document, including additional areas that EPA may consider for inclusion. 

1:00 P.M.	Lunch Break

2:00 P.M.	Charge Question 5:

As described in Section 1.1, EPA has identified evaluations conducted by multiple other regulatory agencies and authoritative bodies, including U.S. CPSC, Health Canada, Australia NICNAS, and the European Food Safety Authority. Please identify any additional notable phthalate CRAs that the panel is aware of that may inform EPA's proposed approach. 

2:30 P.M	Charge Question 6:

In Section 2.1, EPA defines some key concepts relevant to the CRA. Please comment on the clarity and appropriateness of EPA's definition for these terms with respect to the phthalate proposed cumulative approach.

3:15 P.M.	Charge Question 7:

In Section 3.1.3, EPA summarizes available data for seven key outcomes associated with the development of phthalate syndrome for the five high-priority and two manufacturer-requested phthalates. Please comment on the key outcomes associated with the "phthalate syndrome" identified by EPA for focusing its phthalate CRA
 
4:00 P.M.	Charge Question 8:

Sections 3.1.6 and 3.1.7 describe EPA's weight of evidence analysis and proposed conclusions regarding toxicologic similarity for the five high-priority and two manufacturer-requested phthalates. EPA has preliminarily concluded that DEHP, BBP, DBP, DIBP, DCHP, and DINP (but not DIDP) are toxicologically similar and can induce effects consistent with phthalate syndrome in rats. However, EPA acknowledges that DINP is less potent than the other evaluated phthalates. Please comment on the strengths and uncertainties of this preliminary conclusion.

4:45 P.M.	 Adjourn

                                         Day 3
                                Wednesday May 10, 2023
                                       
                                         Day 3
                                Wednesday May 10, 2023
                                       

10:00 A.M. 	Opening of Meeting  -  Alaa Kamel, Ph.D., Designated Federal Official, OPS, OCSPP, EPA 

10:05 P.M. 	Panel Members: Follow-Up on Previous Day Presentations  -  Daniel Schlenk, Ph.D., Chair Science Advisory Committee on Chemicals (SACC) 

10:15 A.M. 	Charge Question 9:

Section 3.2 provides a qualitative evaluation of the available evidence of human co-exposure to the five high-priority and two manufacturer-requested phthalates. Based on available human biomonitoring data (i.e., NHANES) and evidence of exposure through manufacturing and/or industrial, commercial, or consumer use, EPA has preliminarily concluded that there is evidence that humans are co-exposed to or have the potential to become co-exposed to DEHP, BBP, DBP, DIBP, DCHP, DINP, and DIDP. EPA acknowledges that there is less robust evidence to support co-exposure to DCHP. Please comment on the strengths and uncertainties of EPA's preliminary conclusion. 

11:00 A.M.	Charge Question 10:

 EPA's proposed phthalate cumulative chemical group for CRA, based on the weight of evidence supporting toxicologic similarity and human co-exposure, is described in Section 3.3. Please comment on EPA's preliminary proposal to include DEHP, BBP, DBP, DIBP, DCHP, and DINP in the cumulative chemical group under TSCA. In your response, and in light of comments on charge questions 8 and 9, please include a discussion of the strengths and uncertainties of this preliminary conclusion.

11:45 P.M.	Charge Question 11:

 In Section 4.1, EPA describes two options for addressing phthalate syndrome -- assessing the syndrome as a whole and focusing on the most sensitive effect. Please comment on the strengths and uncertainties of EPA's preliminary proposal to address phthalate syndrome under TSCA by focusing on the most sensitive effect(s). 

12:30 P.M.	Lunch Break

1:30 P.M. 	Charge Question 12:

In Section 4.2, EPA describes the applicability of dose addition for evaluating phthalates for cumulative risk to human health. Please comment on the appropriateness of EPA's proposal to evaluate phthalates under an assumption of dose addition. 

2:15 P.M.	Charge Question 13:

In the National Research Council's 2008 report Phthalates and Cumulative Risk Assessment: The Tasks Ahead, the NRC recommended against the use of a relative potency factor (RPF) approach for phthalates because phthalates exbibit dose-response curves with differing slopes and shapes. However, based on scientific analysis developed since the publication of the 2008 report (described in Section 4.3.3), EPA considers the RPF approach to be scientifically supportable for phthalates. Please comment on the strengths and uncertainties of using a RPF approach for phthalates. 

3:00 P.M.	Charge Question 14:
 
Section 4.4 describes six options EPA is considering for deriving RPFs for phthalates. Please comment on the strengths and uncertainties of the proposed options. Please describe any additional options EPA may consider for deriving RPFs for phthalates.
 
3:45 P.M.	Charge Question 15:

In Section 5.0, EPA proposes that the potentially exposed and susceptible subpopulations (PESS) that may be more susceptible to phthalate syndrome, include 
:: pregnant women/women of reproductive age, and 
:: male infants, male toddlers, and male children. 
EPA proposes to focus its CRA for phthalates on these susceptible subpopulations and add others through the risk evaluation process as applicable. Please comment on the strengths and uncertainties of this proposal.

4:30 P.M.	Adjourn	
									
                                         Day 4
                                 Thursday May 11, 2023
                                       
                                         Day 4
                                 Thursday May 11, 2023
                                       

10:00 A.M. 	Opening of Meeting  -  Alaa Kamel, Ph.D., Designated Federal Official, OPS OCSPP, EPA 

10:05 P.M. 	Panel Members: Follow-Up on Previous Day Presentations  -  Daniel Schlenk, Ph.D., Chair Science Advisory Committee on Chemicals (SACC) 

10:15 A.M. 	Charge Question 16:

In Section 6.3.2, EPA describes two approaches (scenario-based and reverse dosimetry) for estimating non-attributable and non-TSCA exposure (Step 5 in the Conceptual Model [Figure 2-1]). In Section 6.3.2.5, EPA proposes to primarily utilize the scenario-based approach (described in Section 6.3.2.1) to estimate non-attributable and non-TSCA exposures for combining with TSCA exposures. The Agency proposes to use the reverse dosimetry approach (described in Section 6.3.2.2) as a comparator for scenario-based daily intake estimates (i.e., help contextualize whether scenario-based estimates are an over or underestimation of total exposure) and to analyze temporal trends to better understand changes in phthalate exposure over time. a) Please comment on the strengths and uncertainties of EPA's proposed approach to primarily assess the non-attributable and non-TSCA exposure using a scenario-based method. 
 b) EPA recognizes there are limitations and uncertainties with the proposed reverse dosimetry approach outlined in Section 6.3.2.2, which relies on Equation 6-1. Given these uncertainties and limitations, please comment on EPA's proposal to use reverse dosimetry as a supplementary approach to help characterize exposure and use it as a comparator for exposure estimates from the scenario-based approach. 
 c) EPA recognizes that intake estimates using scenario-based approach may not be directly comparable to estimates from a reverse dosimetry approach. Please comment on how these estimates can or cannot be calibrated to each other based on the uncertainties of each approach. 
 
11:00 A.M.	Charge Question 17:

In Section 6.3.2.1, EPA briefly discusses a tiered approach to exposure assessment based on data availability, where different tiers may utilize deterministic or probabilistic models. Exposures from different exposure scenarios may be estimated using different tiers of models based on data availability and combined to determine cumulative exposure. Section 6.3.2.4 discusses the uncertainties of combining exposures estimated using different tiers of assessment. Please comment on the challenges associated with combining exposure estimated across different tiers of exposure assessment and potential solutions. 

11:45 P.M.	Charge Question 18:

As shown in Step 4 - 5 of EPA's conceptual model (Figure 2-1), and subsequently described in detail in Section 6.4.1 and 6.4.2 for consumers and workers, EPA proposes to consider non-attributable and non-TSCA exposure for combining with TSCA exposures for consumer and occupational conditions of use (COUs) in Step 9 that are identified as major exposure pathways and are anticipated to lead to co-exposure. Please comment on strengths and uncertainties of this approach. If appropriate, please provide alternative approaches that the EPA may consider for determining cumulative exposure.

12:30 P.M. 	Lunch Break

1:30 P.M.	Charge Question 19:

In Section 6.4.1.2, EPA proposes an approach to determine co-exposure to multiple phthalates from consumer TSCA COUs for consumers as part of Step 7 of EPA's conceptual model (Figure 2-1). EPA discusses the limited data to support co-exposure to multiple phthalates across different consumer TSCA COUs as well as the limited data to support the co-occurrence of multiple phthalates within a single product. Please comment on strengths and uncertainties of this approach. If appropriate, please provide information on additional existing data that EPA may consider for determining co-exposure to consumer products.

2:15 P.M.	Charge Question 20:

In Section 6.4.2.2, EPA proposes an approach to determine co-exposure to multiple phthalates from occupational TSCA COUs for workers as part of Step 7 of EPA's conceptual model (Figure 2-1). In the absence of workplace monitoring data, EPA proposes to utilize release estimates to determine the potential for co-exposure to workers in a workplace setting. Please comment on strengths and uncertainties of this approach. If appropriate, please provide information on additional existing data that EPA may consider for determining co-exposure for workers. 
 
3:00 P.M.	Charge Question 21:

In Sections 6.4.3.2 and 6.4.3.3, EPA proposes a step-wise approach to determine co-exposure to individuals who may be part of a fenceline community and who are also consumers and/or workers. However, EPA has not identified a proposed methodology, data sources, or lines of evidence to fully develop the cumulative fenceline assessment. Please provide information on existing data sources that EPA may consider for developing the cumulative fenceline assessment. 

3:45 P.M.	Closing Remarks and Meeting Adjourn
													

Please be advised that agenda times are approximate; when the discussion for one topic is
completed, discussions for the next topic will begin. For further information, please contact the
Designated Federal Official for this meeting, Alaa Kamel, PhD via email: kamel.alaa@epa.gov