Document ID: EPA-HQ-OPPT-2019-0501-0093
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-06-11T04:00Z

Additional Questions from SACC Members on OPPT Presentation on June 8:

Several of the questions asked by Committee Members relate to what they refer to as the "regulatory nexus". There is a need for EPA to present the" bigger picture," describing ( or depicting) the boundaries EPA has placed around the TSCA risk evaluations and where these boundaries intersect with other EPA, Federal and other regulatory programs listed in Section 1.3. In addition, Table 1-2 lists the assessment history of asbestos. How does this evaluation relate to these previous assessments in terms of subject and scope? 

 Can EPA request, (or mandate) the collection of exposure data (e.g. require monitoring) when risk scoping and problem formulation indicate risk for potential exposures under a specific COU? A related question: can OPPT require manufacturers/importers/processors collect/provide monitoring data through NPDES (or any other means) for COUs scoped to have potential hazard?  If so, how long would it take to get these data?  

 Does TSCA require the conclusions of a risk assessment be reported as binary, that is the risk conclusion is stated as either yes or no?  Can the risk evaluation end in a conclusion that there is not enough information (eg.  There is no exposure data, hazard is unknown) to characterize risk (e.g. "lacks sufficient information to make a reasoned evaluation" for other than new chemicals)?

 Slide 30 indicates "low to medium uncertainty" regarding minimal to low surface water discharge.  However, on page (bottom) 52 (and other locations), the DRE states "Asbestos releases from chlor-alkali facility treatment systems to surface water and POTWs are not known. While the treatment technologies employed would be expected to capture asbestos solids, the precise treatment efficiency is not known. Chlor-alkali facilities are not required to monitor effluents for asbestos releases, and EPA's broader research into this COU did not find asbestos water release data."  These statements indicate significant uncertainty (generated by the total lack of measured data).  Is there a unique definition of "uncertainty" by the Agency that ignores lack of data for a conclusion?

 EPA should consider the Gig economy when developing the consumer examples of brake examples where EPA assumed only one brake job every 3 years. And one job in a lifetime? Did EPA consider the Gig economy? Suggest they add at least one example to cover that use  -  or EPA could indicate the minimum number of jobs in a lifetime or 5-year period that would result in reaching the "unreasonable risk" level. 

 When there are multiple companies that provide monitoring data EPA appears to combine all the data and then calculate "central tendency" and "high end" summary statistics. Does EPA first look to see if the individual company data have similar central tendencies and if dissimilar consider weighting the data from each facility so that one company does not dominate and skew the summary statistic for the industry? 

 Does EPA request the monitoring plan strategies from the data submitters? 

 Slide 49 of the presentation suggests that EPA's interest in including non-malignant lung disease mortality of the risk evaluation may have evolved. Please share how the EPA thinking on this may be changing?

 Table 1-1 (slide 12) describes chrysotile p-chem properties. Can the stated fiber lengths in Table 1-1 (<1000 to ≈ 10,000 um) be easily reconciled with the long fiber/short fiber arguments in the human health literature that emphasize lengths of less than versus greater than 5 um?  EPA answered that the lengths in Table 1-1 pertain to agglomerates in commercial products. This produced a follow-up question as to whether the distribution of particle sizes in commercial chrysotile is known?

 Following up a comment by Dr Davies:  The exposure to asbestos as a contaminant of talc raises the question of whether it is the association of asbestos with talc, the size of the asbestos, or the area exposed (vaginal) that allows the asbestos to enter the body. With some consumer uses (brake grinding, taconite mining, living close to or living with taconite mining), whole body exposures to dust containing asbestos might represent a scenario similar to dusting the body with talc in which case this would impact how dermal exposures are addressed. 

 Where will contaminated products as talc be considered if they are not in this DRE. Asbestos has been found in products like crayons, so it's not just cosmetics regulated by FDA. Linda Reinstein from ADAO mentioned crayons, toys, and paints.

 The question on the timeline was answered.

 Why is EPA not considering legacy exposures and risks in THIS DRE? Consideration of legacy uses/exposures/risks seems to be required given the recent lawsuit.  Saying that legacy uses will be considered in a later supplement is not the reason for putting off these issues.