EDF submits comments for peer reviewers on EPA’s exposure, use and hazard information on five PBT chemicals

Lindsay McCormick, is a Project Manager. Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday, EDF filed comments on several draft EPA documents that are part of the basis for developing restrictions EPA is required to impose on five persistent, bioaccumulative and toxic (PBT) chemicals under the 2016 reforms made to the Toxic Substances Control Act (TSCA).  The draft documents are to undergo peer review, and EDF’s comments raise issues we believe peer reviewers need to pay particular attention to.

As required by TSCA section 6(h), EPA last year identified five PBT chemicals (DecaBDE, HCBD, PCTP, PIP (3:1), and 2,4,6 TTBP) that meet the statutory criteria for “expedited action”: By June 22, 2019, EPA must propose a rule to restrict these five chemicals.  Last month, EPA released draft documents for peer review and public comment that summarize available hazard information and assess exposure and use of each of the five PBTs.

Our main points for consideration for the peer review committee are summarized below:

Exposure reduction is a key driver:  The data and analyses need to support EPA’s promulgation of rules that meet the requirement to “reduce exposure to the extent practicable” as well as to eliminate unreasonable risk.  For many uses, meeting the exposure reduction requirement can and should drive deeper cuts in use of PBT chemicals than simply eliminating unreasonable risk, up to and including bans on some or all uses.  For example, where a viable alternative exists, a ban would be necessary to comply with the requirement that EPA “reduce exposure to the chemical substance to the extent practicable.”

Need to identify potentially exposed or susceptible subpopulations:  EPA has not included, and should add, a section to each document identifying the relevant potentially exposed or susceptible subpopulations it can now identify based on the information it has already provided in the documents, and EPA should update these as more information is developed.

Exposure is likely to each of the five PBTs:  The draft exposure and use assessment confirms that exposure “is likely” for each of the five PBT chemicals EPA has identified.  Each of these chemicals is, by definition, persistent and bioaccumulative, which means people and other organisms can remain exposed to it for a very long time, with those higher up the food chain more heavily exposed.  All five of these PBT chemicals appear to still be active in commerce.  And monitoring data show that exposure is likely to each of the five chemicals.

EPA must consider all conditions of use:  This includes so-called legacy-related use and disposal as well as conditions of use related to recycling and imported articles.

EPA statements suggesting certain exposures are low lack sufficient evidence:  Certain EPA statements invoking existing regulations (sometimes in countries other than the U.S.), suggesting reductions in use over time, or characterizing specific scenarios suggest that some exposures to PBT chemicals are low or have declined.  For reasons discussed in our comments, these statements are questionable or lack sufficient evidence.

EPA can and should use its authorities to address gaps in available information:  TSCA gives EPA ample authority to require testing or monitoring and to collect existing information in order to fill gaps in hazard and exposure or use information.  EPA should use these authorities where needed to inform robust exposure reduction rules for the five PBT chemicals.

EPA has inappropriately excluded reasonably available information, including through its literature search strategy:  EPA has not yet summarized relevant information it already received on the PBT chemicals under its TSCA sections 4 and 8 authorities.  EPA has also excluded large numbers of studies due to “time constraints” (see draft supplemental document).  EPA should immediately provide a list of references to all excluded studies to peer reviewers and the public in advance of the upcoming peer review.  EPA should also promptly initiate efforts to acquire and make public copies of the full studies as soon as possible.

EPA needs to identify all types of acute and subacute as well as chronic hazards:  EPA’s focus only on repeated-dose studies in the hazard summary is overly narrow, given EPA’s mandate to reduce human risks from all hazards.

Find our full comments here for additional detail.

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