1 

# Testing Strategy for MCCPs and LCCPs

EPA anticipates that each company will need to modify the cited test guidelines or propose the use of alternate test guidelines when preparing draft study protocols to fulfill the testing strategy presented herein. Each company must document all proposed modifications from the test guidelines in the draft study protocols, provide rationales for the modifications, and submit the draft study protocols to EPA for review and approval prior to finalizing the study protoco ls and commencing performance of the studies.

The test substances to be used will be representative congener groups to serve as surrogates for

the PMN substances and must be synthesized and characteri z ed. The test substances are

described below. This is necessary to address confounding issues in existing studies and to

reduce uncertainties in the database for both the range of chlorination and alkyl chain length.

The testing strategy is presented in three phases

. Phase 1 studies will inform environmen tal transport and partitioning. Phase 2 will evaluate the potential environmental transformation with identification of major degradants and bioaccumulation of the test substances and/or the degradants . Phase 3 will evaluate potential toxicity of the paren t substance and/or degradants

identified under Phases 1 and 2

.

For each study specifying analytical determination of congener groups, EPA expects each

company to be able to identify, with appropriate mass balance, the alkyl chain length and weight

percen t chlorine of the test samples, sorption/desorption fractions, transformation products, etc.



## Synthesis and Characterization **of Substances to be Tested**

Each company must synthesize and characterize the following representative congener groups (hereinafter referred to collectively as the “test substances”):

• Three chlorinated linear C 14 paraffin fractions to represent the 30

- , 56

- , and

> 70

- weight

- percent chlorine (wt% Cl);

• Three chlorinated linear C 16 paraffin fraction s to represent the 3 0

- , 56

- , and

> 70

- wt % Cl; and

• Three chlorinated linear C 18 paraffin fractions to represent the 30

- , 56

- , and

> 70

- wt% Cl.

The characterization of the test substances must be performed using appropriate analytical

methods ( e.g. , GC/MS

, HPLC/MS) that provide the carbon chain length and the wt% Cl. 1 Each

1 See, e.g. , Jana Hüttig and Michael Oehme (2006) Congener group patterns of chloroparaffins in marine sediments obtained by chloride attachment chemical ionization and electron capture negative ionization

, C HEMOSPHERE , Vol. 64, pp. 1573

- 1581, at p. 1576 (Figure 1).2 company must provide EPA with a certificate of analysis and all “ raw data ” 2 f rom the analys e s of the test substances

.



## Phase 1 Testing: **Environmental Transport and Partitioning**

Under Phase 1 , each company must perform the testing described in this section on each of the test substances. The testing strategy is based on the Agency’s need for information on the environmental transport and partitioning of the test substances. The testing is aimed at determining wh ere the test substances partition when released to a biological wastewater treatment plant (WWTP) and to the environment through discharges to surface water (Phase 1 b).

Phase 1 a

• OPPTS Test Guideline 835.1110: Activated Sludge Sorption Isotherm with analytical procedures capable of measuring sorption of congener groups over time

.

Phase 1 b

• OECD Guideline 106: Adsorption

– Desorption Using a Batch Equilibrium

Method with analytical procedures capable of measuring sorption and desorption

of congen er groups over time.

If the results from Phase 1 a and 1 b testing show that the test substances partition to either of these compartments ( i.e., sludge and soil) , then these results will inform Phase 3 testing.



## Phase 2 Testing: **Transformation Studies**

Un der Phase 2

, EPA will evaluate the Phase 1 testing results to determine the appropriate compartments for conducting transformation studies. For example, the Phase 1 results will

inform whether the Phase 2 transformation testing is needed in soil (Phase 2 a) , sediment (Phase

2 b), and water (Phase 2 c) compartments, respectively. For each compartment evaluated, INEOS

Chlor Americas must ensure that the studies are designed using analytical procedures that are capable of identifying and quantifying degradation p roducts.

Phase 2 a

• OECD Guideline 307: Aerobic and Anaerobic Transformation in Soil with analytical procedures capable of measuring the test substances and their degradation products

over time.

2 Note, the terms “raw data” as used herein are the same as defined under 40 CFR Part 792

– Good Laboratory Practice Standards, §792.3 Definitions.3 Phase 2 b

• OECD Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems with analytical procedures capable of measuring the test substances and their degradation products over time

.

Phase 2 c

• OPPTS Test Guideline 835.5270 : Indirect Photolysis Screening Test: Sunlight Photolysis in Waters Containing Dissolved Humic Substances with analytical procedures capable of measuring the test substances and their degradation products

over time.

Phase 2 d testing must be performed on the test substances and degradants identified in Phases 2 a, b, c.

Phase 2 d

• OECD Guideline 317: Bioaccumulation in Terrestrial Oligochaetes with analytical procedures capable of measuring the test substances and their degradation products ;

• OECD Guideline 315: Bioaccumulation in Sediment

- dwelling Benthic Oligochaetes with analytical procedures capable of measuring the test substances and their degradation products ; and

• OECD Guideline 305: Bioaccumulation in Fish: Aqueous and Dietary Exposur e. The dietary exposure protocol must be used with analytical procedures capable of measuring the test substances and their degradation products

.



## Phase 3 Testing: **Toxicity Testing** 

Under Phase 3

, the degradants identified under the Phase 2 testing will be subject to the following toxicity studies in addition to the test substances . Though several test guidelines are listed for each of the following environmental compartments, EPA will determine the appropriate testing requirements based on the environmenta l compartment in which the test substances or degradants were shown to partition or form, respectively, and the physicochemical properties of each.

Phase 3 a

• OECD Guideline 2 22 : Earthworm Reproduction Test ;

Phase 3 b

• OECD Guideline 2 25 : Sediment

- Water Lumbriculus Toxicity Test Using Spiked

Sediment

.

Phase 3 c

• OECD Guideline 211(OPPTS 850.1300) Daphnia magna Reproduction Test.

• OECD Guideline 210 (OPPT 850.1400) Early Life

- stage Toxicity Test.4 If, based on the results of testing conducted, EPA determines that the PMN substance s or any degradation products may present risk s to human health or the environment, EPA may require

additional characterization or restrictions on the manufacture (which includes import)

, processing, distribution, use

, and/ or disposal of the PMN substance s to mitigate exposures to or to better characterize the risks presented by the PMN substance s or their degradation products.