Tag: World Health Organization

Canadian PFAS Drinking Water Standards Proposed

We have documented for several years now the U.S. EPA’s efforts to propose enforceable drinking water standards with respect to PFAS, and in September 2022, the World Health Organization (WHO) issues its own draft “PFOS and PFOS In Drinking-Water” Background Document.  Now, on the heels of these developments, Canadian PFAS drinking water standards were introduced, which add another regulatory layer to the globally evolving PFAS regulatory scheme. Notably, Canada takes a different approach than both the United States and the WHO in addressing PFAS drinking water issues, but the proposal will nonetheless have impacts on U.S. PFAS litigation if passed.

Canadian PFAS Drinking Water Standards

Canada’s draft proposal sets a limit of 30 ppt for any detected PFAS combined in a given drinking water source. This is in contrast to the WHO, which only addressed PFOA and PFOS in its draft recommendations for drinking water standards, and the EPA, which by all indications will only propose enforceable drinking water standards for a small subset of the over 12,000 PFAS that exist. The Canadian standards, though, do propose requiring that EPA Testing Methods 533 or 537.1 be used for detection, which only tests for 29 PFAS types. Nevertheless, the large group approach to PFAS drinking water standards is unique for the moment to Canada, although the WHO did include in its proposal a similar limited subset of PFAS for countries to consider when setting or proposing drinking water standards.

Comments to the Canadian draft document are being accepted through April 12, 2023.

EPA’s Drinking Water Actions

We previously detailed how, on June 15, 2022, the EPA issued Health Advisories (HAs) for five specific PFAS, PFOA (interim), PFOS (interim), PFBS (final) and GenX (final). While not enforceable levels for PFAS in drinking water, the EPA’s PFAS Health Advisories are nevertheless incredibly significant for a variety of reasons, including influence on future federal and state drinking water limits, as well as potential impacts on future PFAS litigation.

The levels set by the EPA’s PFAS Health Advisories were as follows:

PFOA .004 ppt
PFOS .02 ppt
GenX 10 ppt
PFBS 2,000 ppt

Since the HAs were published, the EPA has faced several lawsuits challenging the HAs. The lawsuits generally allege that the HAs should be struck down and are not valid, as they were created “arbitrarily and capriciously.”  In support, the moving parties say that the HAs were created in an improper manner because (1) they incorporated toxicity assumptions that deviate from the EPA’s own standard methods; and (2) EPA incorporated grossly incorrect and overstated exposure assumptions―in essence, EPA used the wrong chemical when making its exposure assumptions, thereby resulting in a significantly less tolerant health advisory for [PFAS] than is warranted by the data. In addition, the parties argue that the EPA failed to go through the necessary public comment period before issuing its final GenX HA, and that in creating the GenX HA, the EPA exceeded its authority under the Safe Drinking Water Act.

Canadian PFAS Impacts On EPA Efforts and Litigation

When the WHO PFAS report was released, we wrote that the report will have an impact on existing and future litigation that challenges EPA regulatory actions focused on PFAS. Our reasoning for the prediction was that the standards proposed by the WHO were significantly higher than the EPA’s Health Advisories (which may foreshadow where the EPA’s enforceable drinking water limits will be set) even though the WHO had available to it much of the same scientific literature as the EPA. The Canadian PFAS drinking water proposal of 30 ppt is also higher than the EPA’s Health Advisories and what many predict will be the EPA’s proposed enforceable drinking water limit.  Future legal arguments challenging the EPA will likely say that the EPA is acting by ignoring the science and putting politics over the merits of scientific endeavor.

Nevertheless, whether the arguments challenging the EPA are found to be meritorious in litigation or not, the Canadian report will certainly provide ammunition to parties looking to challenge EPA action.

Conclusion

Now more than ever, the EPA is clearly on a path to regulate PFAS contamination in the country’s water, land and air. The EPA has also for the first time publicly stated when they expect such regulations to be enacted. These regulations will require states to act, as well (and some states may still enact stronger regulations than the EPA). Both the federal and the state level regulations will impact businesses and industries of many kinds, even if their contribution to drinking water contamination issues may seem on the surface to be de minimus. In states that already have PFAS drinking water standards enacted, businesses and property owners have already seen local environmental agencies scrutinize possible sources of PFAS pollution much more closely than ever before, which has resulted in unexpected costs. Beyond drinking water, though, the EPA PFAS Roadmap shows the EPA’s desire to take regulatory action well beyond just drinking water, and companies absolutely must begin preparing now for regulatory actions that will have significant financial impacts down the road.

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FDA Requests Comments on WHO Recommendation to Classify Two Common Industrial Solvents as Psychotropic Substances

Beveridge & Diamond PC environmental and energy law firm

On January 27, 2015, the Food and Drug Administration (“FDA”) requested comments on a recommendation by the World Health Organization (“WHO”) to classify two common industrial solvents – gamma-butyrolactone (“GBL”) and 1,4-butanediol (“BDO”) – as psychotropic substances under Schedule I of the 1971 Convention on Psychotropic Substances (“Psychotropic Convention”). See 80 Fed. Reg. 4283.  The comments will be used by the Secretary of Health and Human Services (“HHS”) to prepare a recommendation on the WHO proposal to the Secretary of State, which will be binding on the U.S. representative to the upcoming 58th Session of the UN Commission on Narcotic Drugs (“CND”) in Vienna, Austria, on March 9-17, 2015.  At the Vienna meeting, CND may accept the WHO recommendations, reject the recommendations, or decide to control the chemicals in another way (i.e., under a different Schedule of the Convention).

FDA notes that if either chemical – or any of the other chemicals that are also recommended for listing, but are not addressed here because they have few, if any, legitimate industrial uses – are added by CND to Schedule I of the Psychotropic Convention, the U.S. will have to impose additional controls on the chemical(s) under the Controlled Substances Act (“CSA”) administered by the Drug Enforcement Administration (“DEA”).  Although FDA does not elaborate on what those controls might consist of, they would likely include additional restrictions on manufacture, distribution, import, and export of the chemicals, as well as enhanced recordkeeping and reporting requirements. For example, Article 2(7)(a)(i) of the Psychotropic Convention states that parties shall require licenses for manufacture, trade, and distribution of Schedule I substances.  Moreover, Article 7(a) provides that parties must “[p]rohibit all use [of Schedule I substances] except for scientific and very limited medical purposes by duly authorized persons,” although Article 2(7)(a) allows individual parties to notify the UN that they cannot do so as a result of “exceptional circumstances,” in which case the party need only “take into account” the prohibition “as far as possible.”

It is worth noting that GBL is already regulated under the CSA as a precursor to gamma-hydroxybutyric acid (“GHB”), which is a commonly abused central nervous system depressant drug that is currently regulated under Schedule II of the Psychotropic Convention and Schedule I of the CSA.  In particular, GBL is classified under the CSA as a “List I” precursor (not to be confused with a CSA Schedule I or other controlled substance), and thus is already subject to significant DEA controls.  In addition, some U.S. states and authorities in some other countries already regulate GBL directly as a controlled substance or its equivalent.  Nevertheless, the addition of GBL to Schedule I of the Convention would likely require new and more stringent controls in most jurisdictions.  Additional information on the basis for the WHO recommendation for GBL (including the chemistry of the chemical, abuse potential, legitimate uses, and current regulation around the world) can be found in the 2014 GBL Critical Review Report of the WHO Expert Committee on Drug Dependence.

BDO is also a precursor to GHB, but is not currently regulated under the CSA.  It is regulated in several U.S. states and other countries as a precursor or controlled substance equivalent.  Once again, however, if it is added to Schedule I of the Psychotropic Convention, it will likely become subject to substantial additional restrictions.  Additional information on the basis for the WHO recommendation for BDO can be found in 2014 BDO Critical Review Report of the WHO Expert Committee on Drug Dependence.

FDA will accept written comments on the WHO recommendations until February 26, 2015.  Requests for a public meeting will be accepted until February 6, 2015.

ARTICLE BY

Aaron H. Goldberg
OF
Beveridge & Diamond PC