Document ID: EPA-HQ-OPPT-2019-0237-0041
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2019-08-28T04:00Z

STATE OF WASHINGTON
                             DEPARTMENT OF HEALTH
                OFFICE OF ENVIRONMENTAL PUBLIC HEALTH SCIENCES
        243 Israel Road SE  PO Box 47825 Olympia, Washington 98504-7825
                       TDD Relay Service: 1-800-833-6384
                                       

July 31, 2019
Scientific Advisory Committee on Chemicals
Draft Risk Evaluation for Cyclic Aliphatic Bromide Cluster 
Rosslyn, VA

      Good afternoon. I am Dr. Holly Davies, a toxicologist at the Washington State Dept. of Health here to comment on the draft risk evaluation for Hexabromocyclododecane (HBCD). 
      As other people have mentioned, there is too much material to carefully review all of it before this opportunity to speak with you. There may be material in the draft that I have missed in preparing these comments. 
      Washington State has been concerned about flame retardants for quite some time, especially persistent, bioaccumulative, and toxic chemicals (PBTs) like HBCD. The State Departments of Health and Ecology have worked together to address these risks to human health and the environment. We operate under a different authorizing environment than TSCA and the Dept. of Health has supported the concepts in state bills to ban halogenated flame retardants when there is good scientific evidence to support that they are toxic, they are in consumer products or in people, and there are safer alternatives that don't compromise fire safety. We also support stopping the use of PBTs whenever possible, because of their persistence and accumulation in organisms and in the food chain.  
      Because PBTs pose a unique threat to human health and the environment, in 2006 Washington State adopted our PBT Rule that included HBCD on our list of PBTs and laid out our process to enhance how we address PBTs through the use of Chemical Action Plans. We completed a Chemical Action Plan for another group of flame retardants, polybrominated diphenylethers (PBDEs), and have continued to work on reducing exposure to PBDEs and other flame retardants, including HBCD. The Dept. of Ecology has also completed studies to analyze for flame retardants in environmental media and consumer products. EPA also considers HBCD a PBT, but did not expedite action on this chemical because they had already completed a Work Plan Problem Formulation for it, which made it ineligible for the expedited process for PBTs under the updated TSCA. 
      Washington's Children's Safe Products Act (CSPA) includes HBCD as a Chemical of High Concern to Children. The 2011 rule requires manufacturers to report HBCD's presence in children's products sold in Washington State. We've been concerned about HBCD for the same reasons as in this risk evaluation, which are effects on thyroid, liver, reproduction and development. In 2016 our state law was amended to ban HBCD and four other additive flame retardants in children's products and residential upholstered furniture as of July 1, 2017. The legislature also directed the Departments of Ecology and Health to further investigate six additional flame retardants and recommend actions. More recently the legislature passed additional legislation on a class of flame retardants and gave more authority to the Dept. of Ecology. This is to discourage the use of regrettable substitutes and encourage manufacturers to use safer alternatives. The existing bans in Washington have focused on children's exposure and children's products, not because that is where HBCD is most used, but because we are concerned about children's greater susceptibility and we don't want manufacturers to increase their use of HBCD for children's products as a regrettable substitute. 
      Table A.2 in Appendix A on state laws includes Washington's state ban on HBCD in specific products in the detailed description, but not the larger description of what the state actions are. The table doesn't include that Minnesota banned HBCD in 2015 and expanded their law in 2019 to ban organohalogen flame retardants. Since 2017 several states have passed broad flame retardant bans on specific products that would include HBCD. 
      EPA noticeably has not used its new authority under the updated TSCA to order manufacturers to provide additional information before the next round of CDR in 2020 and relies on the 2016 CDR and additional information from manufacturers on how much HBCD is produced/imported. It also relies on assurances that HBCD is no longer made in certain facilities, not likely to be made by small facilities that are not required to report, and not made by other countries and imported to a large amount. While information from manufacturers can be quite useful, in Washington State we experienced misrepresentations by the brominated flame retardant industry in particular, as documented in the series by the Chicago Tribune Playing with Fire. There seems to be different standards for different information used in the risk evaluation and industry information does not go through the same systematic review and data quality assessment.
      There could be a lot more HBCD made in other countries and imported into the US, including in products, than EPA acknowledges. The draft risk evaluation notes that 171 of 188 Parties to the Stockholm convention on Persistent Organic Pollutants have agreed to ban the production, use, import, and export of HBCD, but does not mention which countries have not agreed. This document also mentions that only three Parties have registered for an exemption for production for EPS and XPS in buildings, but does not mention that one of the three countries is China and none of them report the volumes they are producing or using. 
      This draft risk evaluation states that uses such as high impact polystyrene in electronics, textiles, coatings, furniture and children's products are discontinued uses and does not address those uses of HBCD in consumer products. In our CSPA database we have reports of HBCD used as a flame retardant at in the range of 1000-5000 ppm for three children's products, with the most recent report from 8/24/18. On p.39 you mention a past use of bean bag chairs, which may be an unreferenced reference to our product testing database where were detected HBCD in a child's chair in 2013. 
      EPA should include consumer products in its risk evaluation. TSCA directs EPA to evaluate chemicals under conditions of use that are "circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." While EPA cannot evaluate all possible uses, it is reasonably foreseen that HBCD would be used in ways that it has been used recently and for which there is no independent verification that it is no longer used and that HBCD would be used in ways that similar flame retardants are being used. 
      EPA should more carefully consider children's exposure and children as a susceptible subpopulation. In 4.4.1 EPA discusses taking age-specific differences into account, but does not identify children as a susceptible subpopulation due to their greater exposure. The risk evaluation takes into account dust ingestion, which may account for exposure from existing products in the home, but it was hard to tell if the exposure assessment fully considered children's exposure even though child-specific exposure factors were used. EPA presented without comment, data showing that the fetal and placental exposures are much higher than other exposures (Figure 2-2) and does not mention higher infant exposures compared to mothers, as in the biomonitoring study by Kim and Oh (2014). 
      EPA finds risks of HBCD exposure to the environment and workers but then states they are not unreasonable risks. For the environment EPA does not follow standard practice of acceptable risk being a risk quotient below 1. While a risk quotient of 1 does not have to be a bright line, a risk quotient of 5 is not close to 1. An additional consideration for risk that is not mentioned is that HBCD is a PBT that will persist in the environment and build up in the food chain and that is a reason to be more cautious rather than less cautious. The importance of PBTs is specifically mentioned several times in TSCA. 
      EPA also found risks to workers, but stated they are not unreasonable when PPE is used. Earlier in the document (p. 180) EPA correctly describes the hierarchy of controls with elimination first as the most effective measure to address hazardous exposures in the workplace and PPE last in the hierarchy. By finding risk to workers and then determining the use of PPE makes this risk not unreasonable, EPA is turning this hierarchy on its head. In addition, it is not correct to state that because an SDS suggests use of PPE that employers will provide equipment and workers will always use the equipment properly. 
      While Washington's existing ban on HBCD will not be preempted, we are concerned about state preemption if EPA determines there is no unreasonable risk from a chemical. This determination of no unreasonable risk for HBCD seems to rest on industry assurances that this chemical is no longer used, but EPA's determination will preempt state actions even if manufacturers begin using it again next year. 
      It's important for EPA to make its determinations on data and not on the lack of data. We recommend EPA use approaches described in the new report from the National Academies of Science, Engineering, and Medicine A Class Approach to Hazard Assessment of Organohalogen Flame Retardants, in which they placed HBCD in a subclass of flame retardants and recommended ways to fill data gaps using data from other flame retardants and new approach methodologies.  
      Thank you for the opportunity to speak.