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CHEMICAL SAFETY ADVISORY COMMITTEE (CSAC)

OPEN MEETING

May 24 and 25, 2016

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

OPPT Docket: EPA-HQ-OPPT-2015-0805

Crystal City Marriott 

1999 Jefferson Davis Highway

Arlington VA 22202

Hotel Phone #: 703-413-5500

Peer Review of the Draft Risk Assessment for TSCA Work Plan 

Chemical, 1-Bromopropane (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

9:10 AM Introduction of Committee Members - Kenneth Portier, Ph.D., Chair of the 

CSAC

9:15 AM Welcome and Opening Remarks – Stan Barone Jr., M.S., Ph.D., Acting 

Director, Office of Science Coordination and Policy, EPA and Wendy ClelandHamnett, J.D., Director, Office of Pollution Prevention and Toxics, EPA 

9:30 AM Introduction and Background – Tala Henry, Ph.D., Director, Risk Assessment 

Division, Office of Pollution Prevention and Toxics, EPA

10:00 AM Overview of the Draft Risk Assessment for TSCA Work Plan Chemical, 1-

Bromopropane (CASRN-106-94-5) – Katherine Anitole, Ph.D., and Greg 

Macek, Risk Assessment Division, Office of Pollution Prevention and Toxics, 

EPA

10:30 AM Break

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

Bromopropane (CASRN-106-94-5) Continued – Katherine Anitole, Ph.D., and 

Greg Macek, Risk Assessment Division, Office of Pollution Prevention and 

Toxics, EPA

12:00 PM Lunch

1:00 PM Public Comments 
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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 the 

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. Please 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 Questions 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 aware 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.

5:00 PM Adjournment 
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WEDNESDAY, MAY 25, 2016

Crystal City Marriott

1999 Jefferson Davis Highway

Arlington VA 22202

Hotel Phone #: 703-413-5500

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

9:05 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

9:30 AM Charge Questions to the Committee Continued

Consumer Exposure Assessment

Question 3-1: Please comment on the approach used 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 exposure 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 cleaners 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 assessment 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 Questions 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 risk 
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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 these 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 scenarios. 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 

benchmark 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 standard 

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 weaknesses 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.

EPA/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-cancer 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 consumers 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, strengths and weaknesses of the MOE 

approaches used to estimate the non-cancer risks to workers and occupational non-users 
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following chronic inhalation exposures to 1-BP, including the MOEs presented in the document. 

Please comment on the selection of uncertainty 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 

characterization.

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.