Document 71BGGNo1XRdBbK0921rkvo2d8
Comments:
I.
Given the breadth and scope of beneficial uses of PFAS in society, we have grave concerns
related to the proposed total ban of all PFAS currently used within the industrial use sectors,
and the risks associated with what are now unknown replacements/alternatives.
It appears that authors of the proposed regulation share our concerns on the appropriateness of banning all of the over 10,000 PFAS based on general conclusions drawn a scant few studies on a relatively few select substances. Note that "Annex to Annex XV Restriction Report" section B.1.2 acknowledges that ".......... due to the wide scope of the proposed restriction entry and the large number of substances covered by this restriction proposal, general conclusions on the physicochemical properties of all PFASs are complicated or even impossible."
II.
From the perspective of industrial uses, the general conclusions for all PFAS based on data
from a select few presents an unbalanced regulatory approach that almost will certainly
result in the outlaw of substances that present minimal risk but provide significant benefit.
We propose granting an additional option as suggested in B.1.3. "Justification for Grouping"
"If there are specific PFASs for which sufficient evidence is provided that the perfluorinated
moiety is fully degraded at a rate which indicates them to be not persistent, resulting in a
substance/substances which is/are not a PFAS, then those substances/groups should be
considered excluded from the scope."
We welcome the designations (definitions) in the proposed regulation that provide a clear path to identify what fluorinated substances/mixtures are classified as a PFAS, and a second additional designation for fluorinated substances/mixtures that are not a PFAS.
Given the presence of proposed designations and the aforementioned "general conclusions on the physicochemical properties of all PFASs are complicated or even impossible", we urge regulators to craft regulations to recognize that science will reveal exceptions to the specified designations (in terms of persistence). We urge regulators to include regulatory language that provides for a formal PFAS designation exemption or appeal process with a defined timeline for such a review.
In effect, if a scientific review supports exemption of a specific substance to the PFAS the regulation would make room for a balanced review and allow for exemptions of what would otherwise be regulated as PFAS. A review process would provide for an exemption on a substance based on data that supports the decomposition of a specific PFAS to persistence levels that are acceptable. Exempted chemistries would need to meet what are now standard considerations related to ozone-safe, low GWP and safe human exposure factors that are found in other existing regulations. Inclusion of exemption provisions in this regulation would help speed the process of weeding out the most harmful PFAS and uses that have the most significant persistence in the environment, while allowing the development and use of designated PFAS that have data supporting low persistence and general safety.
Please see our #9 of our submission for examples of studies that support exemption status for substances currently designated as PFAS