28Indicative human health risk for introduction of an industrial chemical

28 Indicative human health risk for introduction of an industrial chemical

(1) For the purposes of step 4 of the method statement in section 24, the following table sets out the indicative human health risk for the introduction of an industrial chemical.

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Indicative human health risk for an introduction</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>If …</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>the indicative human health risk for the introduction is …</span></p></td></tr></thead><tbody><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Medium to high risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the industrial chemical is a designated fluorinated chemical</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>medium to high risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the industrial chemical is a polyhalogenated organic chemical (other than an organic chemical that is covered by item</span><span> </span><span>1); and</span></p><p class="Tablea"><span>(b) the industrial chemical, or one or more of its known environmental degradation products, is persistent; and</span></p><p class="Tablea"><span>(c) the total volume of the industrial chemical to be introduced by the person in a registration year is greater than 100 kg</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>medium to high risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the industrial chemical is an industrial chemical that:</span></p><p class="Tablei"><span>(i) is a solid, or is in a dispersion, at the time of introduction; and</span></p><p class="Tablei"><span>(ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; and</span></p><p class="Tablea"><span>(b) the industrial chemical is not soluble (within the meaning given by the Guidelines); and</span></p><p class="Tablea"><span>(c) the introduction of the nanoscale portion of the industrial chemical is not incidental to the introduction of the non</span><span>‑</span><span>nanoscale portion of the industrial chemical</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>medium to high risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the human health exposure band for the introduction is 2 or 3; and</span></p><p class="Tablea"><span>(b) the industrial chemical has one or more of the human health hazard characteristics in human health hazard band C</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>medium to high risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the human health exposure band for the introduction is 4; and</span></p><p class="Tablea"><span>(b) the industrial chemical has one or more of the human health hazard characteristics in human health hazard band B or C</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>medium to high risk</span></p></td></tr><tr><td colspan="3" style="border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Low risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the industrial chemical is internationally</span><span>‑</span><span>assessed for human health; and</span></p><p class="Tablea"><span>(b) the international assessment or evaluation was:</span></p><p class="Tablei"><span>(i) for the same end use for which the industrial chemical is to be introduced in Australia by the person; and</span></p><p class="Tablei"><span>(ii) for a maximum concentration of the industrial chemical at end use that is the same or higher than the maximum concentration of the industrial chemical at the end use for which the industrial chemical is to be introduced in Australia by the person; and</span></p><p class="Tablea"><span>(c) the risks to human health from the introduction and use of the industrial chemical are no higher in Australia than in the overseas jurisdiction, as determined in accordance with the Guidelines; and</span></p><p class="Tablea"><span>(d) the complete international assessment report for the industrial chemical is available and will be provided to the Executive Director if requested; and</span></p><p class="Tablea"><span>(e) either of the following applies:</span></p><p class="Tablei"><span>(i) if the international assessment or evaluation is of a kind mentioned in item</span><span> </span><span>6 of the table in subsection</span><span> </span><span>6(3)—the restrictions (if any) set out in Annex XVII of the REACH Regulation relating to the industrial chemical are able to be complied with in Australia;</span></p><p class="Tablei"><span>(ii) otherwise—the conditions (if any) that the international assessment body determines must be complied with in order to manage any risks to human health from the industrial chemical are able to be complied with in Australia; and</span></p><p class="Tablea"><span>(f) no further information becomes available to the person after the international assessment or evaluation is completed about:</span></p><p class="Tablei"><span>(i) a hazard to human health from the industrial chemical that is not identified in the international assessment or evaluation; or</span></p><p class="Tablei"><span>(ii) a hazard to human health from the industrial chemical that is identified in the international assessment or evaluation and indicates an increase in the severity of the hazard; and</span></p><p class="Tablea"><span>(g) none of table items</span><span> </span><span>1 to 3 or 12 to 14 apply to the introduction; and</span></p><p class="Tablea"><span>(h) introduction of the industrial chemical is not prohibited (however described) in the overseas jurisdiction</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>low risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the industrial chemical is an industrial chemical that:</span></p><p class="Tablei"><span>(i) is a solid, or is in a dispersion, at the time of introduction; and</span></p><p class="Tablei"><span>(ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; and</span></p><p class="Tablea"><span>(b) the industrial chemical is not soluble (within the meaning given by the Guidelines); and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 5 apply to the introduction</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>low risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the industrial chemical is a UV filter; and</span></p><p class="Tablea"><span>(b) none of table items</span><span> </span><span>1 to 5 apply to the introduction</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>low risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the human health exposure band for the introduction is 1; and</span></p><p class="Tablea"><span>(b) the industrial chemical has one or more of the human health hazard characteristics in human health hazard band C; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 3 apply to the introduction</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>low risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the human health exposure band for the introduction is 3; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band C; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 3 or 14 apply to the introduction</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>low risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the human health exposure band for the introduction is 4; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band B or C; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 3 or 14 apply to the introduction</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>low risk</span></p></td></tr><tr><td colspan="3" style="border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Very low risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>12</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the human health exposure band for the introduction is 1; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band C; and</span></p><p class="Tablea"><span>(c) none of table items</span><span> </span><span>1 to 3, 7 or 8 apply to the introduction</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>very low risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>13</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the human health exposure band for the introduction is 2; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band C; and</span></p><p class="Tabletext"><span>(c) none of table items</span><span> </span><span>1 to 3, 7 or 8 apply to the introduction</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>very low risk</span></p></td></tr><tr><td style="width:8.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>14</span></p></td><td style="width:66.38%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the human health exposure band for the introduction is 3 or 4; and</span></p><p class="Tablea"><span>(b) the industrial chemical does not have any of the human health hazard characteristics in human health hazard band A, B or C; and</span></p><p class="Tabletext"><span>(c) none of table items</span><span> </span><span>1 to 3, 7 or 8 apply to the introduction</span></p></td><td style="width:25.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>very low risk</span></p></td></tr></tbody></table>