Procedural Review of Health Reference Values Established by enHealth for PFAS

In early August 2016 the Department of Health commissioned this review in fulfilment of the Government’s commitment to review the interim human health reference values (HRVs) for per- and poly-fluorinated alkyl substances (PFAS) in drinking water. Delivery of the review was therefore considered urgent and a period of one month was allocated.
The Terms of Reference endorsed by the Government for this independent review are as follows:
“The independent review will consider:
(1) Approaches and assumptions used by the European Food Safety Authority (EFSA), as outlined in the reports Perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA) and their salts, Scientific Opinion of the Panel on Contaminants in the Food Chain (EFSA, 2008) and Perfluoroalkylated substances in food: occurrence and dietary exposure (EFSA, 2012).
(2) Approaches and assumptions used by the United States Environmental Protection Agency (US EPA), as outlined in the 2016 Health Effects Support Document for Perfluorooctane Sulfonate (PFOS) (US EPA, 2016b) and the 2016 Health Effects Support Document for Perfluorooctanoic Acid (PFOA) (US EPA, 2016a).
(3) The applicability and relevance of these approaches and assumptions in the Australian context, having regard to existing Australian regulatory science policy as described in such guidance materials as:
a. Australian Pesticide and Veterinary Medicines Authority (APVMA) Data guidelines (http://apvma.gov.au/registrations-and-permits/data-guidelines) and Application of science to regulatory risk assessment (http://apvma.gov.au/node/15486)
b. the enHealth Environmental Health Risk Assessment, Guidelines for Assessing Human Health Risks from Environmental Hazards (enHealth, 2012);
c. the Food Standards Australia New Zealand (FSANZ) Risk Analysis in Food Regulation publication: (http://www.foodstandards.gov.au/publications/riskanalysisfood regulation/Pages/de fault.aspx (FSANZ)
d. the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Handbook for notifiers: https://www.nicnas.gov.au/regulation-and-compljance/nicnas-handbook (NICNAS)
e. the National Health and Medical Research (NHMRC) Guidelines for Managing Risks in Recreational Water (NHMRC, 2008) and NHMRC Australian Drinking Water Guidelines (NHMRC, 2016).
Given the limited time available, and the considerable body of documentation, the primary focus of this review is to identify the principle sources of variation between the US EPA and EFSA risk assessments of PFAS and the resultant guidance values, to comment on the consistency of the approaches taken with Australian guidance on, and practice of, health risk assessment and to form a view on the suitability of the EFSA values selected by enHealth as an interim measure pending more extensive consideration by FSANZ. In the time available for this review it is not possible to definitively identify one or other of the approaches as “correct” and the other not. Rather, the potential sources of strength and weakness in each assessment are examined together with a consideration of the nature and significance of methodological deviations from general regulatory approaches.