Page 1 of 5 CHEMICAL SAFETY ADVISORY COMMITTEE ( CSAC )

OPEN MEETING May 24 and 25

, 2016 CSAC WEB SITE https://www.epa.gov/csac

OPP T Docket: EPA

- HQ

- OPPT

- 2015

- 0805

Crystal City Marriott

1999 Jefferson Davis Highway Arlington V A 22202

Hotel Phone #: 703

- 413

- 5500



## Peer Review of the Draft Risk Assessment for TSCA Work Plan Chemical, 1

- B romopropane (CASRN

- 106

- 94

- 5)

TUESDAY, MAY 24, 2016

Please note that all times are approximate.

9:00 AM Meeting Opening and Administrative Procedures

– Steven Knott, M.S., Designated Federal Official, Office of Science Coordination and Policy , EPA

9 : 1 0 AM Introduction of Committee Members

- Kenneth Portier, Ph.D., Chair of the

CSAC

9 : 1 5 AM Welcome and Opening Remarks

– Stan Barone Jr., M.S., Ph.D., Acting Director, Office of Science Coordination and Policy, EPA and Wendy Cleland

Hamnett , J.D., Director, Office of Pollution Prevention and Toxics, EPA

9: 3 0 AM Introduction and Background

– Tala Henry, Ph.D., Director, Risk Assessment Division, Office of Pollution Prevention and Toxics , EPA

10:0 0 AM Overview of the Draft Risk Assessment for TSCA Work Plan Chemical, 1

- B romopropane (CASRN

- 106

- 94

- 5)

– Katherine Anitole, Ph.D., and Greg Macek, R isk Assessment Division, Office of Pollution Prevention and Toxics,

E PA

10 :30 AM Break

10:45 AM Overview of the Draft Risk Assessment for TSCA Work Plan Chemical, 1

- B romopropane (CASRN

- 106

- 94

- 5) Continued

– Katherine Anitole, Ph.D., and Greg Macek, Risk Assessment Division, Offi ce of Pollution Prevention and Toxics, EPA

12:00 PM Lunch

1:00 PM Public CommentsPage 2 of 5 2:00 PM Charge Questions to the Committee

General Issues on the Risk Assessment

Question 1

- 1 : Please comment on whether the information provided in Section 1 (Background and Scope) is appropriate and accurately characterizes the fit for purpose nature of this assessment for TSCA related uses? Please provide any specific suggestions for improving th e clarity and transparency of the background information that describes scope and limits of the

assessment.

Question 1

- 2 : Please comment on the scope of the assessment, in particular the conceptual model resulting from EPA/OPPT’s problem formulation. Plea se provide any other significant literature, reports, or data that would be useful to complete this characterization and that may support expansion or refinement of the scope of this assessment.

2:45 PM Break

3: 00 PM Charge Question s to the Committee Continued

Occupational Exposure Assessment

Question 2

- 1 : Please comment on the approaches used, and provide any specific suggestions or recommendations for alternative approaches, models, or information (references) that could be considered by EPA/OPPT for improving the workplace exposure assessment, including estimations for bystander/non

- users (e.g., women of child

- bearing age).

Question 2

- 2 : Please comment on whether there are any additional occupational exposure

scenarios that EPA/OPPT could address that have not already been quantified. Please also provide specific references and/or data to address such additional exposures.

Question 2

- 3 : For the exposure assessments based on monitoring data, are you aware of any additional sources of occupational exposure monitoring data that EPA/OPPT could consider in its assessment? If so, please provide specific literature, reports, or data that would help us refine the exposure assessment.

Question 2

- 4 : For the exposure assessments based on modeling, are you a ware of any additional sources of data that EPA/OPPT could consider in deriving the parameter values used in the modeling? If so, please provide relevant literature, reports, or data that would help us refine the parameters used in the modeling

.

5: 0 0 PM AdjournmentPage 3 of 5 WEDNESDAY , MAY 2 5 , 2016 Crystal City Marriott 1999 Jefferson Davis Highway Arlington V A 22202

Hotel Phone #: 703

- 413

- 5500

Please note that all times are approximate.

9:0 0 AM Meeting Opening and Administrative Procedures

– Steven Knott, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:0 5 AM Introduction of Committee Members

– Kenneth Portier , Ph.D.

, Chair of the

CSAC

9:10 AM Follow

- up from Previous Day’s Discussion (As needed)

– Office of Pollution Prevention and Toxics, EPA

9:3 0 AM Charge Questions to the Committee Continued

Consumer Exposure Assessment

Question 3

- 1 : Please comment on the approach u sed and provide any specific suggestions or recommendations for alternative approaches, models, or use information (e.g., information on duration, number of user events, amount used) that could be considered by EPA/OPPT in developing and /or refining the e xposure assumptions and estimates for spray adhesives, aerosol spot removers and aerosol spray cleaners and degreasers.

Question 3

- 2 : Exposure estimates were developed for three consumer uses: spray adhesives, aerosol spot removers and aerosol spray clean ers and degreasers. All products are aerosol sprays and appear to be available for sale and use by consumers in the U.S. There were no current reliable data regarding the consumer exposure scenarios. Please comment on the consumer uses

selected for this as sessment and provide any specific suggestions or recommendations for additional uses (including information on duration, number of user events, amount used) that

could be considered for evaluation.

10:30 AM Break

10:45 AM Charge Question s to the Committee Continued

Hazard and Dose

- Response Assessments

Question 4

- 1 : EPA/OPPT concluded in the risk assessment that 1

- BP carcinogenesis occurs through a probable mutagenic mode of action based on the totality of the available

data/information and the WOE. Please comment whether the cancer hazard assessment has adequately described the WOE regarding the mutagenic mode of action.

Question 4

- 2 : EPA/OPPT identified liver toxicity, kidney toxicity, reproductive/developmental toxicity, and neurotoxicity in the risk assessment as adverse human health effects for riskPage 4 of 5 characterization. EPA/OPPT used these endpoints to calculate PODs to assess non

- cancer risks associated with chronic inhalation exposures. As part of the review, please comment on the

choice of t hese endpoints as PODs for assessing risks in humans associated with acute and chronic inhalation exposures to 1

- BP. Are there other data that EPA/OPPT could have considered for the hazard identification and dose response associated with chronic inhalation exposures? If so, please provide specific data and references.

12:00 PM Lunch

1:00 PM Charge Questions to the Committee Continued

Question 4

- 3 : Please comment on the WOE analysis for the choices of non

- cancer endpoints for

the acute and chronic risk sc enarios. Please provide additional data, data interpretation or information that would have informed the WOE analysis and selection of critical studies for the

PODs.

Question 4

- 4 : Typically, EPA uses the benchmark dose modeling software (BMDS) with a

benc hmark response (BMR) of 10% and the models are restricted to multistage models or the broader suite of dichotomous models in BMDS and a single best model is chosen for the POD. EPA/OPPT used an alternative approach to calculate the cancer POD versus the st andard approach of choosing best fit model. Briefly, EPA/OPPT used a model averaging approach considering multiple benchmark dose models to calculate the POD at a benchmark response (BMR) level of 0.1%. Please comment on the assumptions, strengths and weak nesses of the model averaging approach for determining the POD in the cancer assessment.

2:30 PM Break

2:45 PM Charge Questions to the Committee Continued

Risk Characterization

Question 5

- 1 : EPA/OPPT interpreted the endpoint of decreases in live litter size following exposure to 1

- BP before and during gestation, as a surrogate for frank developmental effects relevant to humans per EPA’s Guidelines for Developmental Toxicity Risk Assessment.

E PA/OPPT used this endpoint to calculate a point of departure (POD) to assess non

- cancer risks associated with acute inhalation exposures to 1

- BP. Please comment on the assumptions, strengths and weaknesses of the MOE approaches used to estimate the non

- can cer risks to workers and occupational non

- users following acute inhalation exposures to 1

- BP, including the MOEs presented in the document. Please comment on the assumptions, strengths and weaknesses of the MOE approaches used to estimate risks to consumer s following acute inhalation exposures; including non

- users (e.g., bystanders who may be children, or women of childbearing age). Specifically, please comment on the decision to limit the analysis to acute exposures without residual concerns between events and what data could critically inform modifying this approach for consumers. Please comment on the selection of uncertainty factor values in deriving the benchmark MOE for acute inhalation exposures.

Question 5

- 2 : Please comment on the assumptions, stren gths and weaknesses of the MOE approaches used to estimate the non

- cancer risks to workers and occupational non

- usersPage 5 of 5 following chronic inhalation exposures to 1

- BP, including the MOEs presented in the document.

Please comment on the selection of uncertain ty factor values in deriving the benchmark MOE for chronic inhalation exposures.

Question 5

- 3 : Please comment on the assumptions, strengths and weaknesses of the approach

used to estimate added lifetime cancer risks to workers which EPA/OPPT

- derived from an inhalation unit risk based on lung tumors in female mice for estimating incremental or added

individual lifetime cancer risk.

Question 5

- 4 : Please comment on whether the risk characterization has adequately described the assumptions, uncertainties and data limitations in the methodology used to assess risks from 1

- BP. Please comment on whether this information and risk conclusions are presented in a logical, transparent manner and provide suggestions that could increase clarity in the risk

characterizat ion.

5 :00 PM Adjournment

As noted above, please be advised that agenda times are approximate. For further information, please contact the Designated Federal Official for this meeting, Mr. Steven Knott, via telephone: (202) 564

- 0103 or email:knott.steven@epa.gov

.