42359.05.
(a) For purposes of this chapter, all of the following apply:(1) This section provides guidance for assessing the degradability of polymers for the purposes of entry to market: the permitted test methods and the pass criteria for those methods. The test methods were designed to measure biotic degradation, although some abiotic degradation may take place during the test and contribute to the test results.
(2) The biodegradability provisions apply only for the purpose of exempting biodegradable materials from the scope of this chapter.
(3) The tests described in subdivision (b) shall be conducted by
laboratories complying with the principles of good laboratory practice provided for in Directive 2004/10/EC of the European Parliament and of the Council of the European Union or other international standards recognized as being equivalent or accredited to ISO 17025.
(4) The permitted test methods described in subdivision (b) are organized into five groups, on the basis of their design and underlying rationale. Meeting the pass criteria in any of the permitted test methods in groups 1 to 3, inclusive, as described in paragraph (1), (2), or (3) of subdivision (b), is sufficient to demonstrate that the polymer or polymers contained in the tested material and subject to the test are degradable and are therefore excluded from the scope of this chapter. If group 4 or group 5 tests, as described in paragraph (4) or (5) of subdivision (b), are used to demonstrate degradability of polymers for uses other than agricultural and horticultural uses, the
pass criteria shall be met in at least three of the following environmental compartments:
(A) Fresh or estuarine water.
(B) Fresh or estuarine water sediment.
(C) Marine water.
(D) Marine sediment.
(E) Marine water or sediment interface.
(F) Soil.
(b) (1) (A) The group 1 permitted screening test methods are the following:
(i) The “Ready Biodegradability” test (OECD TG 301B, C, D, F).
(ii) The “Ready Biodegradability - CO2 in sealed vessels (Headspace Test)” test (OECD TG 310).
(B) The group 1 pass criteria to demonstrate ready biodegradation is 60 percent mineralization measured, over 28 days, as evolved CO2 or consumed O2. The 10-day window requirement mentioned in the test guidelines listed in subparagraph (A) do not need to be fulfilled.
(2) (A) (i) The group 2 permitted screening test methods are the following:
(I) The “Ready Biodegradability” test (OECD TG 301B, C, D, F).
(II) The “Ready Biodegradability - CO2 in sealed vessels (Headspace Test)” test (OECD TG 310).
(III) The “Biodegradability in Seawater”
test (OECD TG 306).
(ii) The group 2 screening test methods may be extended to up to 60 days and larger test vessels may be used.
(B) The group 2 pass criteria to demonstrate ready biodegradation is 60 percent mineralization measured, over 60 days, as consumed O2, which shall be permitted only for the tests described in subclause (I) or (II) of clause (i) of subparagraph (A), or as evolved CO2. The 10-day window requirement mentioned in the test guidelines listed in subparagraph (A) do not need to be fulfilled.
(3) (A) The group 3 permitted test method is the “Inherent Biodegradability: Modified MITI Test (II)” test (OECD 302C). The preadaptation of the inoculum mentioned in the test guideline shall not be allowed.
(B) The group 3
pass criteria to demonstrate inherent degradation is greater than or equal to 70 percent mineralization measured as consumed O2 or evolved CO2 within 14 days.
(4) (A) (i) The group 4 permitted screening test methods are the following:
(I) Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous medium – Method by analysis of evolved carbon dioxide (EN ISO 14852:2018).
(II) Determination of the ultimate aerobic biodegradability of plastic materials in an aqueous medium – Method by measuring the oxygen demand in a closed respirometer (EN ISO 14851:2004).
(III) Plastics – Determination of aerobic biodegradation of non-floating plastic materials in seawater/sediment interface –
Method by analysis of evolved carbon dioxide (EN ISO 19679:2016).
(IV) Plastics – Determination of aerobic biodegradation of non-floating plastic materials in seawater/sandy sediment interface – Method by measuring the oxygen demand in closed respirometer (EN ISO 18830:2016).
(V) Plastics – Determination of the ultimate aerobic biodegradability of plastic materials in soil by measuring the oxygen demand in a respirometer or the amount of carbon dioxide evolved (EN ISO 17556:2019).
(VI) Plastics - Determination of the aerobic biodegradation of non-floating materials exposed to marine sediment – Method by analysis of evolved carbon dioxide (ISO 22404:2019).
(ii) The specifications set forth in ISO 22403:2020 Plastics – Assessment of the intrinsic
biodegradability of materials exposed to marine inocula under mesophilic aerobic laboratory conditions – Test methods and requirements shall be taken into account when applying subclauses (III) and (IV).
(iii) For group 4 test methods, the preadaptation of the inoculum shall not be allowed. The result shall be reported as the maximum level of degradation determined from the plateau phase of the degradation curve, or as the highest value if the plateau has not been reached. The form, size, and surface area of the reference material shall be comparable to that of the test material. Either of the following materials may be used as reference materials:
(I) Positive controls: biodegradable materials, such as microcrystalline cellulose powder, ashless cellulose filters, or poly-β-hydroxybutyrate.
(II) Negative controls:
nonbiodegradable polymers, such as polyethylene or polystyrene.
(B) The group 4 pass criteria is the ultimate degradation of greater than or equal to 90 percent relative to the degradation of the reference material within either of the following time periods:
(i) Six months in aquatic tests.
(ii) Twenty-four months in soil, sediment, or water and sediment interface tests.
(5) (A) (i) The group 5 permitted simulation test methods are the following:
(I) Aerobic and Anaerobic Transformation in Soil (OECD TG 307).
(II) Aerobic and Anaerobic Transformation in Aquatic Sediment Systems
(OECD TG 308).
(III) Aerobic Mineralisation in Surface Water – Simulation Biodegradation Test (OECD TG 309).
(ii) The required test temperatures for purposes of clause (i) shall be 12 degrees Celsius for fresh or estuarine water, fresh or estuarine water sediment and soil, and 9 degrees Celsius for marine water and marine sediment because these are the average temperatures for that compartment in the European Union.
(B) The group 5 pass criteria to demonstrate degradation under relevant environmental conditions are any of the following:
(i) The degradation half-life in marine, fresh, or estuarine water is less than 60 days.
(ii) The degradation half-life in marine, fresh, or estuarine
sediment is less than 180 days.
(iii) The degradation half-life in soil is less than 180 days.
(c) (1) This subdivision sets forth the permitted test methods and the test conditions to prove that a polymer is soluble for the purposes of entry. The tests shall be conducted by laboratories complying with the principles of good laboratory practice provided for in Directive 2004/10/EC or other international standards recognized as being equivalent or accredited to ISO 17025.
(2) The permitted test methods for purposes of paragraph (1) are the following:
(A) OECD Guideline 120.
(B) OECD Guideline 105.
(3) The
test material shall be comparable in terms of composition, form, size, and surface area to the polymer particles present in the product. For polymeric particles containing inorganic elements, such as particles encapsulated with inorganic substances or particles in which the polymer is grafted onto an inorganic carrier, it shall be sufficient to demonstrate that the polymeric part of the particle meets the pass criteria. This may require the testing of the polymer prior to the formation of the particle.
(4) The conditions for the solubility test shall be the following:
(A) Temperature: 20 degrees Celsius.
(B) pH: 7.
(C) Loading: 10g/1000mL.
(D) Test time: 24 hours.
(5) When performing the solubility test, it shall be demonstrated, by any appropriate means, that the dissolved test material is qualitatively comparable to the polymer present in the synthetic polymer microparticles as released to the environment. In accordance with OECD Test Guideline 120, this shall be determined by either of the following:
(A) One test concentration and direct analysis, by any appropriate means, to demonstrate that the polymer components in the aqueous phase comprise all molecular weight fractions present in the synthetic polymer microparticles.
(B) Two test concentrations and indirect analysis, by any appropriate means, for example, by determining total organic carbon of the aqueous phase and of the undissolved or not-extracted part, demonstrating comparable results at the high and the low test
concentration.