CRC CARE PFAS Guidance

Transcription

1 PFAS Guidance Background information on the derivation of screening levels for PFAS Table 1 Summary of information utilised in the derivation of criteria adopted in guidance, and peer-review General note: For derivation of HSLs. source attribution of TDIs is ~100% less the % background exposure for general population (See NEPM 2003 Schedule B7; ANZECC 1992; consistent with NHMRC). Based on available measured serum data, background exposure in Australia is less than 1% for the TDI values (see #2). The hazard quotient arising from the various contributions from soil or water contamination (ie multiple routes of exposure) should not exceed 1.0 for PFOS (+PFHxS) and PFOA - This provides the way forward for site-specific scenarios and calculations. No Criteria Agency Where derived by References in the Australian method, if Assumptions Input parameters guidance available 1 TDI enhealth 1 Not applicable Not applicable Not applicable Part 2, sections 2.5, 2.6 & Background levels in general Australian population (Dong et al 2016) Direct measurement data for Aust population available for derivation - based on Thompson et al 2011, Karrman et al 2006; Toms et al 2009; Toms et al See Dong et al, Section 4 (report available at Part 2 Appendix A) Also referred to in Part 2, section 2.4. Remarks Guidance adopts Draft enhealth values (based on EFSA 2008) Currently under review by FSANZ 3 Drinking water quality guidance value enhealth 1 Not applicable Not applicable Not applicable Part 2, section 2.6 Guidance adopts Draft enhealth values. 4 HSL water recreational use Yes, NHMRC Guidelines for Managing Risks in Recreational Water NHMRC guidance, section The NHMRC guidance provides for a screening approach in which a substance occurring in recreational water at a concentration of 10 times that stipulated in the drinking water guidelines may merit further consideration In Part 2, section HSL - soil Yes. NEPM Schedule B7 See also, Australian Exposure Factors Guidance 2012 In Part 2, Section 4 See also, NEPM Schedule B7 In Part 2, Appendix B, Table B1-4 (Excel spreadsheet provided separately) Part 2: Section 4 Appendix B All limitations and uncertainties explained in Part 2, section 4.9. See also, additional considerations in application of soil HSLs in Part 4, Table 2. 6 Water and sediment HSLs seafood consumption Not available. Limited sources except RIVM. In Part 2, Section 4.8. Part 2 HSLs allow estimates to be made of the concentration of PFAS that will result in fish and, based on the maximum permissible concentration in fish (MPCfish - refer to Section 4.8.2), HSLs for waters See also below (Table 2, #6) All limitations and uncertainties explained in Part 2, section For example: the water HSLs relating 1 enhealth Statement July 2016 : 1

2 and sediment protective of seafood consumption are derived as discussed in Part 2, Section 4.8 using the RIVM method. guidance in section 4.8 utilises Australian exposure information from the Australian Exposure Factors Guidance, 2012 (Part ), and bioaccumulation factors based on RIVM (see Part 2, ). This option was discussed in detail at the consultation forums and via the discussion document 2015, Preliminary Report: Assessment, management and remediation guidance for perfluorooctanesulfonate (PFOS) and perfluorooctanesulfonic acid (PFOA), 70pp (circulated to consultation forum in March 2015, March 2016). For input parameters, see Part 2, Appendix B. Table B5 Excel spreadsheet provided separately ie Table B5 : TDI (enhealth) Bioaccumulation factors (RIVM) Australian fish consumption rates (Australian Exposure Factors Guidance, 2012) to consumption of fish and other species derived in this report should be used for screening purposes as an indication of the possibility that the fish and other species may be contaminated, and whether further investigation should be undertaken. Where it is considered that further investigation is required, consideration should be given to direct sampling of PFAS concentration in fish and other species in question and compared to the MPCfish 7 ESL - freshwater DoEE 2 Yes, ANZECC Water Quality Guidelines (ANZECC 1992) and the Revised Method for Deriving Australian and New Zealand Water Quality Guideline Values for Toxicants, ESL marine water 9 ESL - soil Yes, ANZECC Water Quality Guidelines (ANZECC 1992), (Revised Method for Deriving Australian and New Zealand Water Quality Guideline Values for Toxicants, 2017) Yes. NEPM, Schedule B5b Derived by DoEE See DoEE s Default guidelines on PFOS and PFOA 2 and ANZECC guidance Part 3 Section 5.2. Section further describes the uncertainties and application of the default guideline values. Derived by as per the ANZECC Water Quality Guidelines (ANZECC 1992). guidance Part 3 Section 5.3 for derivation assumptions and inputs. Uncertainties explained in section As per NEPM, Schedule B5b NEPM Schedule B5b Appendix contains a comparison with overseas methods Limitations / applicability further explained in guidance, Part 3, sections 5.2 & 5.3. See also, application of ESLs, Part 3 section 5.6. Also Part 4, Section 3.4. The derivation processes and assumptions used by and DoEE have been discussed jointly the same methodology has been used. One of the reasons for differences between freshwater and marine GVs is the availability of data for fresh and marine species, including multigenerational studies (described further in the guidance Part 3 at s5.2.1 for freshwater and s5.3.4 for marine water) Also discussed in the Way Forward document circulated to PAG, September 2016 See guidance on the application of ESLs, Part 3 section 5.6. Also Part 4, Section 3.4. guidance Part 3, Section 5.5 for derivation, assumptions and input parameters 10 ESL-sediments (not derived) Refer to Section 5.4; See also Table 2 below at #10 *All guidance also reviewed by PAG members and Consultation Forum (some options presented) 2 Perfluorooctanoic Acid (PFOA) Fresh. Default Guideline Values for Toxicants. Australian and New Zealand Guidelines for Fresh and Marine Water Quality. November Final Draft Perfluorooctane Sulphonate (PFOS) Fresh. Default Guideline Values for Toxicants. Australian and New Zealand Guidelines for Fresh and Marine Water Quality. August Final Draft 3 Revised Method for Deriving Australian and New Zealand Water Quality Guideline Values for Toxicants 2

3 Table 2 Background information on overseas criteria No Criteria Comment on overseas jurisdictions Remarks 1 TDI Subject to review by FSANZ. 2 Background levels in general Australian population 3 Drinking water quality guidance value Subject to review by FSANZ. 4 HSL water recreational use Derived from drinking water value which has been determined by enhealth. Subject to review following FSANZ review. 5 HSL - soil NEPM Schedule B5b Appendix contains a comprehensive review and comparison of Australian approaches and assumptions with overseas methods. Limited guidance available overseas for PFAS in soil. Background of overseas approaches also completed in this project: See Section 5 in 2015, Preliminary Report: Assessment, management and remediation guidance for perfluorooctanesulfonate (PFOS) and perfluorooctanesulfonic acid (PFOA), 70pp (circulated to consultation forum in March 2015, updated version March 2016) 2015, Development of guidance for contaminants of emerging concern, Technical Report no. 32,, 30pp Recent compilation also by DoEE: See Table A1 International and national levels and standards for PFOS in Department of Environment and Energy Commonwealth Guidance on PFAS (draft): 242fe69dad68/files/draft-environmental-mgt-guidance-pfos-pfoa.pdf (see also Appendix A for a listing of other overseas criteria) PAG has recommended using Australian methods, where available. As noted in the previous column, NEPM Schedule B5b Appendix contains a comprehensive review and comparison of Australian approaches and assumptions with overseas methods 6 Water and sediment HSLs seafood consumption Limited guidance overseas, except RIVM. See Table 1 above. Part 2 HSLs allow estimates to be made of the concentration of PFAS that will result in fish and, based on the maximum permissible concentration in fish (MPCfish - refer to Section 4.8.2), HSLs for waters and sediment protective of seafood consumption are derived as discussed in Part 2, Section 4.8 using the RIVM method. Alan Wilson, ERM UK (NICOLE conference, Manchester, July 2015) noted that the RIVM guidance values are very conservative based on very high seafood consumption rates assumed in Denmark, rather than EU. guidance in section 4.8 utilises Australian exposure information from the Australian Exposure Factors Guidance, 2012 (Part ), and utilises bioaccumulation factors based on RIVM (see Part 2, ). guidance in section 4.8 utilises Australian exposure information from the Australian Exposure Factors Guidance, 2012 (Part 4.8.1), and bioaccumulation factors based on RIVM (see Part 2, ). Importantly, the detailed analysis and discussion of the ecosystem-based relationships between PFAS concentrations in water, sediment and aquatic organisms is presented separately in Part 3 of the guidance following the NEPM approach for ESLs (this is further discussed below at # 7 & 8). The guidance - in Part 3, section provides information on alternative screening approaches noting that some the alternate screening approaches incorporate guidance values for ecosystems protective of human health considerations (together with protection of ecosystems) eg RIVM, Canada. The approached used in the Guidance was discussed in detail at the consultation forums and via the discussion document 2015, Preliminary Report: Assessment, management and remediation guidance for perfluorooctanesulfonate (PFOS) and perfluorooctanesulfonic acid (PFOA), (circulated to consultation forum in March 2015, March 2016). For input parameters, see Part 2, Appendix B, Table B5 (Excel spreadsheet provided separately) Also discussed, in the Way Forward document to reflect proposed changes in guidance refer to Section For example: the water HSLs relating to consumption of fish and other species derived in this report should be used for screening purposes as an indication of the possibility that the fish and other species may be contaminated, and whether further investigation should be undertaken. Where it is considered that further investigation is required, consideration should be given to direct sampling of PFAS concentration in fish and other species in question and compared to the MPCfish NB For bioaccumulation and biomagnification consideration in ecosystems, refer to ESL- freshwater and ESL marine (below #7 & 8) 3

4 RIVM has derived maximum permissible concentrations (MPCs) for avoiding secondary poisoning by PFOS in fresh and marine surface waters (RIVM 2010). This approach uses bio-magnification and bio- concentration factors to avoid adverse effects in high level mammalian predators. For the marine environment, RIVM has derived a maximum permissible concentration of μg/l or 0.53 ng/l. For freshwater, the corresponding value is μg/l or 2.6 ng/l. Giesy et. al. (2010) have also derived criteria for PFOS to protect avian wildlife based on bioaccumulation and adverse impact concentrations on higher level avian consumers. The screening level derived by Giesy et al. (2010) to protect avian wildlife is 47 ng/l PFOS. Environment Canada ( has involved developing dietary tissue residue guidelines for PFOS and published draft Federal Environmental Quality Guidelines (FEQGs). These guideline values for the environment are based on studies that seek to directly link laboratory exposure to adverse effects in animals. Guideline values for PFOS to protect mammalian and avian predators are 4.6 (mammalian) and 8.2 ng/g (avian) wet weight food, respectively Minnesota Department of Health (MDH) values PFOS in fish is 40ppb (April 2008). PFOS in fish (ppb) Meal Frequency 40 unrestricted > meal / week > meal / month >800 Do not eat Ontario, Canada, has five inland waterbodies with PFOS-driven fish consumption advisories. Ontario s PFOS consumption restrictions start at fish tissue levels of 80 parts per billion (ppb). At levels over 160 ppb, for sensitive populations, and 640 ppb, for the general population, do not eat advisories are issued. Ontario has also analysed Lake Ontario, St. Lawrence River, Lake Huron, St. Marys River, and Lake Superior fish for PFCs (MOE 2013 cited in Michigan Department of Community Health, 2014). Michigan Fish Consumption Advisory Program (2014). Screening values based on PFOS in fish tissue. 4

5 7 ESL - freshwater The UK Environment Agency stipulates an annual allowable average PFOS concentration of 1 µg/l in freshwater surface waters and an annual allowable average in marine systems of 2.5 µg/l (Seow 2013). The RIVM maximum acceptable concentration (MAC) for ecosystems for freshwater was calculated as 36 µg/l and a serious risk concentration (SRC) of 930 µg/l. The MAC for marine systems is 7.2 µg/l and the SRC is 930 µg/l (RIVM 2010). Giesy (2010) proposes an ecological toxicity criterion for PFOA; this appears to have been developed on a similar basis to ANZECC aquatic protection (species effect levels). The PAG (and consultative forum) have advised that Australian guidance should be based on Australian methods. The ESLs in the guidance incorporate toxicity information as well as bioaccumulation/biomagnification considerations. The guidance uses the NEPM approach which recommends that 5% should be added to each species protection level to take into account bioaccumulation and biomagnification properties, as per Heemsbergen et al. (2009) (In Part 3, Table 17). 8 ESL marine water 9 ESL - soil 10 ESL-sediments (not derived) Further, background completed in this project: See Section 5 in 2015, Preliminary Report: Assessment, management and remediation guidance for perfluorooctanesulfonate (PFOS) and perfluorooctanesulfonic acid (PFOA), (circulated to consultation forum in March 2015, March 2016) 2015, Development of guidance for contaminants of emerging concern, Technical Report no. 32,, Recent compilation also by DoEE: See Table A1 International and national levels and standards for PFOS in Department of Environment and Energy Commonwealth Guidance on PFAS (draft): 48b7-868c-242fe69dad68/files/draft-environmental-mgt-guidance-pfos-pfoa.pdf (see also Appendix A for a listing of other overseas criteria) Limited guidance overseas. The UK Environment Agency (2009) adopts the low reliability Predicted No Effect Concentration (PNEC) of mg/kg for soil for PFOS - based on 95% protection of species. Sediment criteria have been developed for marine sediments in Norway with a PNEC of to 0.22 µg/kg based on no toxic effects (Bakke et al 2010). However, no data or references were provided to support this. There is limited information available in the published literature on the toxicity and bioavailability of PFOS and PFOA in sediments. The PAG (and consultative forum) have advised that Australian guidance should be based on Australian methods. NEPM Schedule B5b Appendix contains a comprehensive review and comparison of Australian approaches and assumptions with overseas methods. See Part 3, section 5.4 for alternative guidance based on variabilities in the ecosystems (eg pore water and water flux). For further information, contact Dr Joyti Jit, Project Manager, (Joytishna.jit@crccare.com) 5