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August 16, 2018
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
1200 Pennsylvania Ave. NW
Washington, DC 20460-0001
Re: EPA–HQ–OPPT–2018–0210; Problem formulation documents for HBCD, DCM, and NMP
The Toy Association appreciates the continued work of the Environmental Protection Agency (EPA) to develop a robust existing chemicals risk evaluation process in the timeframe required by the updated Toxic Substances Control Act (TSCA). The Toy Association is the not-for-profit trade association that represents more than 1,000 businesses – toy manufacturers, importers and retailers, as well as toy inventors, designers and testing labs – who are all involved in bringing safe and fun toys and games for children to market. Toy safety is the top priority for the industry. Our association and its members are leaders in toy safety, dating back to the 1930s, and we place a high value on ongoing programs to ensure safe play.
The Lautenberg Chemical Safety Act (LCSA) of 2016 is a broadly-sweeping piece of legislation that amended several portions of TSCA. A cornerstone of the LCSA is the requirement for EPA to review chemicals in commerce to determine their safety in a timely manner. In December of 2016, EPA announced the first 10 chemical substances that are the subject of the Agency’s initial chemical risk evaluations.1 EPA was required by statute to issue the scope documents for these first 10 chemicals within six months.2 EPA is now seeking comments on the problem formulation documents for these first 10 chemical substances,3 which refine the earlier scopes. The first 10 chemicals include the cyclic aliphatic bromide cluster (including the hexabromocyclododecane cluster, or HBCD), methylene chloride (DCM), and N-methylpyrrolidone (NMP).
With respect to the revised the scope of the HBCD risk evaluation, The Toy Association thanks EPA for recognizing, through an affirmative finding in the problem formulation document, that children’s toys are not an intended condition of use for HBCD. This factual determination is well within EPA’s authority based on the legislative history of the amended TSCA.4 The practice of using flame retardants in toys is rare in general, and to the best of our knowledge HBCD is not used in toys. The inclusion of toys and toy vehicles in the original HBCD scope document was entirely based on three isolated reports over a six-year period by a single importer/distributor under the Washington State Children's Safe Products Reporting Rule (Washington State Rule). The reported concentrations were at extremely low, contaminant levels (not intentionally added). Moreover, flame retardants are typically not used in the types of toys in those reports (toy variety packs and toy vehicles) because they do not present a flammability risk to consumers and are able to easily meet regulatory flammability requirements without their use. Per TSCA section 26, the reported information is not sufficiently reliable to warrant the further attention of the agency. Therefore, we think it is consistent with the approach that EPA outlined in the final risk evaluation rule, and within the scope of the agency’s new authority, to exclude toys as a condition of use in the case of HBCD. This type of strategic and fact-based decision-making helps the risk evaluation process move forward in the timely manner that Congress intended. The remainder of these comments respond further to the revised scopes for DCM and NMP.
The scope of the problem formulation for DCM continues to include potential dermal exposure from toys, including playground and sporting equipment. With respect to the revised scope for DCM, there are only two sources of information that continue to form the basis for identifying toys as a condition of use: a single 2016 Chemical Data Reporting (CDR) submission and a limited number of reports filed under the Washington State Rule. None of the other 32 CDR reports for this high production chemical reported this same use in either 2012 or 2016. With respect to the Washington State Rule reports for DCM, of the 10 companies that submitted these reports, four reported DCM as simply a contaminant. Five of the reporting companies are retailers, so some duplicative product reporting seems likely. Consistent with characterization as an unintentional contaminant, seventy-two percent of the Washington State filings reported extremely low concentrations (less than 500 ppm) with the highest reported level under 10,000 ppm. As the only uses for DCM in toys of which we are aware are as a historical solvent for bonding of polystyrene plastics and as a solvent in paints and inks, we believe that meaningful concentrations in toys are extremely unlikely. We urge EPA to verify the accuracy of these reports.
The scope of the problem formulation for NMP continues to include oral exposure potential from
incidental ingestion during use of product or articles that contain NMP from children’s toys, including arts and crafts kits, and games. With respect to NMP, EPA identifies two pathways for further evaluation in relation to toys: dermal exposure to liquids containing NMP and oral exposure due to mouthing behavior. The Toy Association is not aware of any toys that present a liquid exposure scenario with respect to NMP. The Washington State reports do not establish that a liquid exposure scenario exists, and we did not identify another reference in the problem formulation document that establishes this as a potential exposure pathway for toys. Since 2014, only six reports have been filed for certain dolls, soft toys, and games. None of these product types present the potential for exposure to a liquid containing NMP to consumers in any known, intended, or reasonably foreseeable use pattern of which we are aware. Two reports characterize the presence of NMP as a contaminant in synthetic polymers, which would be handled as a solid and all companies reported the presence of NMP in these products at less than 1,000 ppb. EPA should eliminate liquid exposure through toys as an intended condition of use.
3. Further Comments on Accuracy in Reporting Conditions of Use
Conditions of use are a key concept under the new TSCA law. Knowing this, it is incumbent upon EPA to avoid making overly broad statements and characterizations that could lead to misunderstandings by consumers. In our prior comments, The Toy Association made two specific comments that EPA has not yet addressed but should do so with respect to the scopes for DCM and NMP. We ask EPA to make the following corrections to improve the accuracy with which it reports on toys in the context of characterizing an existing chemical’s conditions of use. First, children’s products and clothing must be a separate category from children’s toys. Although both groups of products are intended for use by children, the exposure and use of chemicals in these products are very different. Second, the primary purpose of the “drinking bird” product is for basic chemistry and physics education. It is most often described, advertised and sold as a science teaching tool or scientific novelty item. Throughout EPA’s DCM documents, it is misrepresented as a toy. We do not consider this product a toy. The product manufacturer specifically states that the product is not a toy on the container for the item. We thus ask EPA to refrain from using the term “toy” for this product in the future, and also urge EPA to recognize that the term “toys” is often used colloquially to indicate a broad category of children’s products, many of which are not truly toys; examples are juvenile child care articles, bicycles, sporting goods, and children’s musical instruments. EPA should therefore strive for precision in describing the category of product involved. We specifically refer EPA to ASTM F963, which as a mandatory federal consumer product safety rule, includes definitions of “toy” and “non-toy items” for incorporation by reference.
ADDITIONAL RECOMMENDATIONS AND REQUESTS
Toys and the ingredients they contain are highly regulated to ensure safe play by the Consumer
Product Safety Commission (CPSC) through the Consumer Product Safety Act (CPSA), the Consumer Product Safety Improvement Act (CPSIA), the Child Safety Protection Act (CSPA) and the Federal Hazardous Substances Act (FHSA). However, The Toy Association advocated for a reformed TSCA and the federal preemption provisions it contains to promote a uniform national process for reviewing chemicals in commerce. State chemical regulatory programs can result in complex, duplicative, and costly compliance activities that often do not contribute to the safety of children’s products. We understand that a key prerequisite for securing TSCA preemption is for a use to be designated and reviewed as a condition of use in an EPA risk evaluation.
We appreciate EPA’s leadership in evaluating HBCD, DCM, and NMP. The intent of our feedback is to help improve the accuracy and strength of EPA’s analysis at the risk evaluation stage. The information reported in the revised scopes for DCM and NMP bear out their incidental presence in toys. While EPA may, on a case-by-case basis, exclude uses that EPA has sufficient basis to conclude would present only ‘de minimis’ exposures,5 for these two chemicals The Toy Association specifically asks EPA to further the preemptive effect of TSCA and find that there is a sufficient basis to conclude that there is no unreasonable risk presented by the presence of these low level impurities in toys, which are ‘de minimis’ and insignificant.
Furthermore, we ask EPA to reach this conclusion as soon as possible in the process. The agency has previously concluded that “[A]t any point after EPA has issued its final scope document, in cases where EPA has sufficient information to determine whether or not the chemical substance presents an unreasonable risk under particular conditions of use, the agency may issue an early determination for that subset of conditions of use.”6 The Toy Association urges EPA to take this approach and make early and preemptive determinations of safety with respect to DCM and NMP in toys. Consistent with the legislative history referenced above, the risk evaluation process allows EPA to learn about all the uses of a chemical and then focus most of the agency’s resources on the conditions of use that raise the greatest potential for risk. Early determinations of safety further the reasonable timeframes for existing chemical reviews consistent with our understanding of the law.
Finally, while we are confident that the facts support a safety finding in these cases, The Toy Association reminds EPA that the new TSCA law calls on EPA to identify laws that are administered by other federal agencies for regulating the potential hazards EPA identifies at the future risk management stage. Therefore, at the point of risk management with respect to toys, we think EPA should always consider and defer when possible to CPSC’s longstanding and effective statutes before developing risk management measures under TSCA. The FHSA and CPSIA regulate exposure from potentially hazardous chemicals in a toy by requiring that they be inaccessible to the child after Use and Abuse Testing and/or limiting content to prevent potentially hazardous exposure. In addition, the FHSA is a protective standard covering exposure rates of chemicals to consumers, and specifically children. These requirements give CPSC the authority to regulate the use of chemicals in consumer products by labeling and by imposing chemical bans in consumer products as necessary; under the statutes administered by CPSC, federal preemption also exists to promote uniform national standards for toy safety.
The Toy Association looks forward to continuing to serve as an authoritative reference for EPA on the use of existing chemicals in toys. If you have any questions, please contact Ed Desmond at firstname.lastname@example.org in our Washington, DC office.
Thank you again for the opportunity to comment on this matter.
President & CEO
1 81 Fed. Reg. 91927, as required by TSCA § 6(b)(2)(A).
2 Environmental Protection Agency, Scopes of the Risk Evaluations to Be Conducted for the First Ten Chemical Substances
Under the Toxic Substances Control Act; Notice of Availability, 82 Fed. Reg. 31592 (July 7, 2017).
3 Environmental Protection Agency, Problem Formulations for the Risk Evaluations to be Conducted Under the Toxic
Substances Control Act, and General Guiding Principles to Apply Systematic Review in TSCA Risk Evaluations; Notice of
Availability, 83 Fed. Reg. 26998 (June 11, 2018) (Comment period subsequently extended until August 16, 2018).
4 82 Fed. Reg. at 33728, noting the June 7, 2016 Cong. Rec. on pp. S3519-S3520.
5 82 Fed. Reg. at 33729.