Government Assessments of Flame Retardants Affected by CPSC Decision

Government authorities have conducted assessments of the use of specific non-polymeric, additive organohalogen flame retardants and determined that they present no significant health or environmental risk. These studies differ from hazard assessments, which are designed to find an adverse effect, in that they incorporate exposure in order to evaluate the potential for real-world risk to human health and the environment. Consideration of both hazard and exposure is a fundamental tenant of effective chemical management as recognized by the Federal Hazardous Substances Act (FHSA).

Environment Canada and Health Canada Assessment of TBBPA and Related Compounds

The Canadian Environmental Protection Act requires the Minister of the Environment and the Minister of Health to conduct screening assessments of substances of potential concern to determine whether they present or may present a risk to the environment or to human health. Following an extensive review of available hazard and exposure data for TBBPA, TBBPA bis(allyl ether), and TBBPA bis(2-hydroxyethyl ether), they concluded that the three substances:

  • “[A]re not entering the environment in quantities or concentrations or under conditions that constitute or may constitute a danger in Canada to human life or health . . .”[i] and
  • “[A]re not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.”[ii]

European Chemicals Bureau Assessment of TBBPA

In 2006, the ECB published a risk of assessment of TBBPA.[iii] The analysis examined multiple endpoints—acute toxicity, irritation, corrosivity, sensitization, repeated dose toxicity, mutagenicity, carcinogenicity, and reproductive toxicity—from inhalation, ingestion, and dermal exposure routes. The Bureau’s conclusions were as follows:

  • Regarding human health, “No health effects of concern have been identified for TBBPA.”[iv]
  • Regarding workers, “No health effects of concern to adults have been identified.” Furthermore, There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.”[v] This conclusion applied “in relation to all endpoints and for all exposure scenarios.”[vi]
  • Regarding consumer exposure, “consumer exposure is negligible” and the findings were identical to those for workers for all endpoints.[vii]

European Chemicals Bureau Assessment of TCPP

For TCPP, ECB found “no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.”[viii] The study also noted that TCPP meets neither the bioaccumulation nor toxicity criteria for designation as a persistent, bioaccumulative, and toxic (PBT) substance. The conclusion applied to potential risk to workers, consumers, humans exposed via the environment, and combined exposure.[ix]

European Chemicals Bureau Assessment of TDCP

The ECB’s 2008 assessment of TDCP is similar to the TCPP assessment described above. For TDCP, ECB found:

  • For environmental toxicity, “There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.”[x]
  • With respect to human health and consumer exposure, “There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.” The conclusion “applies to all consumer exposure scenarios for the endpoints acute toxicity, irritation, sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity, effects on male fertility, and developmental toxicity.”[xi]
  • The ECB noted a lack of data on female fertility and reviewed other data to determine if risk could still be characterized for this endpoint. The ECB assessors determined that “the endpoint for female fertility is likely to be already covered by the Lowest Observed Adverse Effect Level” and that any risk for female fertility would be covered by the repeat dose and carcinogenicity assessments.”[xii] In other words, the assessors found no reason for additional information and/or testing or risk reduction measures.

European Food Safety Authority (EFSA) Panel on Contaminants in the Food Chain (CONTAM Panel) Scientific Opinion on TBBPA

The European Commission directed EFSA’s CONTAM Panel to deliver a scientific opinion on potential risks from TBBPA and its derivatives in food. The panel produced a comprehensive aggregate assessment that also included consideration of exposure to breast-fed infants with average or high milk consumption, as well as exposure to TBBPA in dust in homes, classrooms, and cars. They concluded that:

  • For consumers of fish and consumers of cow’s milk (the latter of which is particularly important for assessing exposures to infants and small children), “current dietary exposure to TBBPA for these population groups in the EU does not raise a health concern.”[xiii]
  • More generally, given the extremely low levels of TBBPA in food (below the level of quantification[xiv]), “it is unlikely that current dietary exposure of the general population to TBBPA raises a health concern.”[xv]
  • Regarding breast-fed infants, “Exposure of breast-fed infants to TBBPA via human milk . . . does not raise a health concern.”[xvi]
  • And finally, “combined exposure to TBBPA from food and dust, particularly for children, is unlikely to raise a health concern.”[xvii]

[i] Environment Canada and Health Canada. 2013. Screening Assessment Report Phenol, 4,4'-(1-methylethylidene) bis[2,6-dibromo-, Ethanol,2,2' [(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxy]]bis, Benzene, 1,1'-(1-methylethylidene)bis[3,5-dibromo-4-(2-propenyloxy)-. Page 6.
[ii] Id. at 43.
[iii] European Chemicals Bureau. 2006. European Union Risk Assessment  Report. 2,2’,6,6’-tetrabromo-4,4’-isopropylidenediphenol (tetrabromobisphenol-A or TBBP-A) Part II – human health.
[iv] Id. at VI.
[v] Id.
[vi] Id.
[vii] Id.
[viii] European Chemicals Bureau. 2008. European Union Risk Assessment Report Tris(2-chloro-1-methyl ethyl) phosphate (TCPP). Page 8.
[ix] Id. at 14.
[x] European Chemicals Bureau. 2008. European Union Risk Assessment Report Tris[2-chloro-1-(chloromethyl)ethyl] phosphate (TDCP). Page IX.
[xi] Id.
[xii] European Chemicals Bureau. 2008. European Union Risk Assessment Report Tris[2-chloro-1-(chloromethyl)ethyl] phosphate (TDCP). Page IX. Page 187.
[xiii] CONTAM (European Food Safety Authority Panel on Contaminants in the Food Chain). 2011. Scientific Opinion on Tetrabromobisphenol A (TBBPA) and its derivatives in food. EFSA Journal 9(12):2477. Page 54.
[xiv] The limit of quantification is the concentration that can reliably be measured by an analytical method.
[xv] Id. at 4.
[xvi] Id. at 55.
[xvii] Id.