United States
Environmental Protection Agency
United States
Environmental Protection Agency
Premanufacture Notification Number: P-12-0453-0433
Office of Chemical Safety and Pollution Prevention
Premanufacture Notification Number: P-12-0453-0433
Office of Chemical Safety and Pollution Prevention

                       TSCA New Chemicals Review Program
                      Standard Review Risk Assessment on

                      Medium-Chain Chlorinated Paraffins
                                (PMN P-12-0453)

                                      and

                       Long-Chain Chlorinated Paraffins
                                (PMN P-12-0433)

This assessment was conducted under EPA's TSCA Section 5 New Chemicals Review Program. EPA is assessing Medium-Chain Chlorinated Paraffin (MCCP) and Long-Chain Chlorinated Paraffin (LCCP) chemicals as part of its New Chemicals Review program. As with all Premanufacture Notice (PMN) submissions, EPA followed the approaches, methods and statutory provisions of TSCA section 5 for the chlorinated paraffin PMNs assessments as well as general EPA risk assessment practices (USEPA 1988, 2014). Finally, a draft of this assessment was made public to request more information and receive public comment (USEPA, 2015).

                                  CONCLUSIONS

Based on its assessment of the available surrogate hazard and exposure information on P-12-0453 and P-12-0433, EPA/OPPT concludes the following pertaining to the manufacturing, processing and use of these PMN substances:

1. Occupational Exposures: Given the assumptions, data and scenarios evaluated in this assessment, there were no risks found for workers from either dermal or inhalation exposures to either of the PMN substances.

2. General Population Exposures (from environmental releases): Given the assumptions, data and scenarios evaluated in this assessment, there were no risks found to humans from environmental releases via exposure to drinking water for either of the PMN substances, or from exposure via from fish ingestion (P-12-0433, the LCCP). There were three scenarios (3 out of 44) where potential risks to the general population due to fish ingestion were identified using the E-FAST modeling results. These scenarios were further evaluated using the highest measured values of MCCPs in fish. Using these measured values and high-end (95[th] percentile) fish intake assumptions, there were no risks identified. There were no risks found to humans from environmental releases via inhalation exposures from emissions from facilities for either PMN.

3. Environmental Assessment:
a. Using the conventional EPA PMN method of estimating water concentrations, all of the intended processes and uses for P-12-0453 and 0433 are expected to result in releases to the surface water at concentrations that may present an unreasonable risk following acute and chronic exposures to aquatic organisms. Use of additional information submitted in response to comments on a previous draft did result in decreases of estimated risk values for some scenarios.

b. Using available measured concentrations of MCCP and LCCP congener groups in the environment as supporting information, the PMN substances:
            i.	Are expected to partition to sediment and may partition to soil through land application of biosolids, and
            ii.	May be released to the environment at water concentrations that may present an unreasonable risk following acute and chronic exposures to aquatic organisms.
            iii.	May be released to the environment resulting in sediment concentrations that may present an unreasonable risk following chronic exposures to sediment organisms.

4. PBT Assessment: The PMN substances may be very persistent and very bioaccumulative.

 TABLE OF CONTENTS
TABLE OF CONTENTS	3
1	INTRODUCTION	6
1.1	PMNS RECEIVED	6
1.2	CHEMISTRY	6
1.3	USES	9
2	ENVIRONMENTAL FATE	9
2.1	ENVIRONMNETAL PERSISTENCE	10
2.2	BIOCONCENTRATION AND BIOACCUMULATION	11
3	ECOLOGICAL HAZARD OVERVIEW	13
4	HUMAN HEALTH HAZARD OVERVIEW	16
4.1	MCCP HEALTH DATA REVIEW	16
4.2	LCCP HEALTH DATA REVIEW	18
5	EXPOSURE INFORMATION	19
5.1	ENVIRONMENTAL MONITORING	19
5.2	MODELED ENVIRONMENTAL RELEASES	22
5.2.1	Assessment Scope	22
<IP_ADDRESS>	P-12-0453 (MCCP)	22
<IP_ADDRESS>	P-12-0433 (LCCP)	23
5.2.2	Assessment Approach	23
5.2.3	Environmental Release Assessment	24
5.2.4	Summary of Release Assessment	26
5.2.5	Modeled Environmental Concentrations	27
5.3	OCCUPATIONAL EXPOSURE ESTIMATES	29
5.3.1	Assessment Scope	29
5.3.2	Assessment Approach	30
5.3.3	Summary of Occupational Exposure Assessment	31
5.3.4	CONSUMER EXPOSURE ESTIMATES	32
6	RISK ASSESSMENT	32
6.1	ENVIRONMENTAL ASSESSMENT	32
6.1.1	Risk Estimates Using Environmental Monitoring Concentrations	32
6.1.2	Risk Estimates Using Modeled Exposures	34
6.2	HUMAN HEALTH	37
6.2.1	Workers	37
6.2.2	General Population	40
7	CONCLUSIONS	46
8	REFERENCES	48
9	APPENDICES	62
Appendix A	ENVIRONMENTAL FATE AND BIOACCUMULATION STUDY SUMMARIES	63
A-1	ENVIRONMENTAL PERSISTENCE	63
A-1-1	Abiotic Degradation	63
A-1-1-1	Fate in Air	63
A-1-2	Biodegradation	64
A-1-2-1	Fate in Wastewater Treatment	64
A-1-2-2	Fate in Surface Water, Sediments and Groundwater	65
A-1-2-3	Fate in Soil	65
A-2	BIOCONCENTRATION AND BIOACCUMULATION	70
Appendix B	ECOTOXICITY STUDY SUMMARIES	79
B-1	MCCP ECOTOXICITY DATA	79
B-1-1	Acute Fish Toxicity	79
B-1-2	Acute Aquatic Invertebrate Toxicity	80
B-1-3	Algae Toxicity	83
B-1-4	Chronic Fish Toxicity	84
B-1-5	Chronic Aquatic Invertebrate Toxicity	87
B-1-6	Chronic Aquatic Sediment Invertebrate Toxicity	90
B-1-7	Avian Toxicity	92
B-1-8	Terrestrial Invertebrate Toxicity	93
B-1-9	Terrestrial Plant Toxicity	94
B-1-10	Conclusions	95
B-2	LCCP ECOTOXICITY DATA	96
B-2-1	Acute Fish Toxicity	96
B-2-2	Acute Aquatic Invertebrate Toxicity	97
B-2-3	Aquatic Plant Toxicity	98
B-2-4	Chronic Fish Toxicity	99
B-2-5	Chronic Aquatic Invertebrate Toxicity	99
B-2-6	Chronic Aquatic Sediment Invertebrate Toxicity	103
B-2-7	Avian Toxicity	103
B-2-8	Terrestrial Invertebrate Toxicity	103
B-2-9	Terrestrial Plant Toxicity	103
B-2-10	Conclusions	103
Appendix C	HUMAN HEALTH HAZARD STUDY SUMMARIES	105
C-1	MCCP HEALTH DATA REVIEW	105
C-1-1	Metabolism	105
C-1-2	Acute Toxicity	105
C-1-3	Irritation and Sensitization	106
C-1-4	Repeated-dose Toxicity	106
C-1-5	Genotoxicity	107
C-1-6	Carcinogenicity	107
C-1-7	Developmental Reproductive Toxicity Review	112
C-2	LCCP HEALTH DATA REVIEW	118
C-2-1	Metabolism	118
C-2-2	Acute Toxicity	118
C-2-3	Irritation and Sensitization	118
C-2-4	Repeated-dose Toxicity	119
C-2-5	Genotoxicity	119
C-2-6	Carcinogenicity	119
C-2-7	Developmental Reproductive Toxicity Review	119
Appendix D	ENVIRONMENTAL MONITORING	123
D-1	MCCP MONITORING DATA	123
D-1-1	Surface Water	123
D-1-2	Sediment	125
D-1-3	Biosolids and Soil	134
D-1-4	Biota	134
D-2	LCCP MONITORING DATA	137
Appendix E	ENGINEERING (ChemSTEER) REPORTS ON P-12-0-0433 and P-12-0453	138
Appendix F	EXPOSURE SCENARIO ESTIMATES	165
Appendix G	SUPPLEMENTAL INFORMATION	169

INTRODUCTION
PMNS RECEIVED
INEOS Chlor Americas, Inc. (hereinafter "INEOS") submitted two Premanufacture Notices (PMNs) identified by the Environmental Protection Agency/Office of Pollution Prevention and Toxics (EPA/OPPT) as either medium-chain chlorinated paraffins (MCCPs; P-12-0453) of varying chain lengths with the formula CxH(2x-y+2)Cly and "x" equaling 14 to 17 and "y" equaling 6 to > 24 or long-chain chlorinated paraffins (LCCPs; P-12-0433) of varying chain lengths with the formula of CxH(2x-y+2)Cly and "x" equaling 18 to 20 and "y" equaling 6 to > 24. Table 1 lists the basic information INEOS supplied on these two PMNs which are intended to be sold under the trade name "Cereclor[(R)]".

Table 1: Identification, Production Volume and Use of P-12-0453 and P-12-0433
                                      PMN
                                 Chemical Name
                             1[st] Year Production
                                  Volume (kg)
                            % PMN in final Product
                                     Uses
                                    Log KOW
                               Water Solubility
                                   P-12-0453
                            Alkanes, C14-17, chloro
                             (MCCPs; 40-60 wt% Cl)
                                      CBI
                                     5-20
74%: lubricant in metal working fluids (MWFs);
17%: flame retardant/plasticizer in polymers;
7%: plasticizer in adhesives; and
2%: lubricant in sealants.
                                   4.70 (E)
                              < 0.03 mg/L (E)
                                   P-12-0433
                            Alkanes, C18-20, chloro
              (LCCPs; 40-55 weight percent chlorination [wt% Cl])
                                      CBI
                                      15
100%: lubricant in MWFs
                                   7.46 (E)
                              < 0.006 mg/L (E)
E = Estimated

Though the specific PMNs in this application include MCCPs and LCCPs, this standard review presents data and information on short-chain chlorinated paraffins (SCCPs) and on very long-chain chlorinated paraffins (vLCCPs) analogs. The continuum of carbon chain length and degree/percent chlorination (wt% Cl) in all of the chlorinated paraffins (CPs) is important and the relationship among them needs to be kept in mind.

CHEMISTRY
Shown below are the structures and chlorine content of P-12-0453 and P-12-0433 products are shown below.

P-12-0453: the average molecular formula ranges from C14H26Cl4 (low weight at ~40 wt% Cl) to C17H26Cl10 (high weight at ~60 wt% Cl). The parent hydrocarbon had the following measured composition: C14, 36 wt% (range 30-40 wt%); C15, 30 wt% (range 25-35 wt%); C16, 24 wt% (range 20-30 wt%); and C17, 10 wt% (8-18 wt%).

P-12-0433: the average molecular formula ranges from C17H31Cl5 (low weight ~40 wt% Cl) to C20H34Cl8 (high weight ~50 wt% Cl). The parent hydrocarbon had the following measured composition: C17, 17.06 wt% (max 20 wt%); C18, 64.71 wt% (range 45-70 wt%); C19, 13.67 wt% (range 15-27 wt%); and C20, 2.13 wt% (range 4-12 wt%).

CPs have an unknown or variable composition (classified as UVCB compounds for TSCA Inventory purposes) of polychlorinated n-alkanes. The carbon chain length usually varies between 10 and 30 carbon atoms and the degree of chlorination can vary between 30 and 75 wt%. EPA/OPPT subdivides CPs according to their carbon chain length into the following categories:

 SCCPs (C10-13)
 MCCPs (C14-17)
 LCCPs (C18-20)
 Very long-chain CPs (vLCCP, C>20)

SCCPs and MCCPs exist as liquids at standard temperature and pressure. CPs with a carbon chain length > 18 are subdivided based on their physical state, which is a function of chain length and chlorine content. The LCCPs and vLCCPs up to 70 wt% Cl are typically liquids (40  -  55 wt% Cl) while above 70 wt% Cl they are waxy solids.

CP products contain a variety of carbon chain lengths that have been chlorinated to different degrees (i.e., variation in the number and position of the chlorine atoms on the carbon chain). The individual isomer content of commercial CPs is rarely identified because the number of possible individual congener group is extremely large. Consequently, the physicochemical properties of CPs vary by carbon chain length and chlorine content. Increased molecular weight correlates to higher melting and boiling points, lower vapor pressures and water solubilities, and greater LogKOW (logarithm of octanol:water partition coefficient). EPA/OPPT used the physicochemical properties listed in Table 2 for informing its evaluation of P-12-0453 and P-12-0433.

Table 2: Summary of Physiochemical Information[a,b]

                                    wt% Cl
                                 Melting Point
                                 Boiling Point
                                Vapor Pressure
                               Water Solubility
                                    Log KOW
MCCPs
> 40
< 25°C
(pour point)
> 200°C (dec)
< 0.036 Pa
at 20 °C
27 ug/L
at 20°C
> 5.5 (measured)
8.30 (estimated)[c][,][d]
LCCPs
> 40
< 25°C
(pour point)
> 200°C (dec)
< 2.7 x 10[-4] Pa
at 20 °C
5 ug/L
at 20°C
> 8
[a]Source: ECB (ECB, 2008); EA (2009)
[b]Because most CP products are liquids and the CPs begin decomposing at 200 °C (via loss of HCl), melting point and boiling points are considered less important in characterizing hazard and risk.
[c]Value calculated using the KOWWIN Program (v1.68) available in EPA/OPPT's Estimation Programs Interface (EPI) Suite TM. This estimate was generated using a representative MCCP (i.e., C14H24Cl6, 52 wt% Cl) with the following SMILES notation: CCC(Cl)CC(Cl)CCCl)CC(Cl)CC(Cl)CC(Cl)C.
[d]The ECB (ECB, 2008) cited Renberg's liquid chromatography to measure a LogKOW between 5.5 and 8.2 and then chose to use a Log KOW = 7 as a representative LogKOW for MCCPs with 45-52 wt% Cl.

Analytical challenges exist with evaluating CPs due to the sheer number of congener groups that may be present in CP products. The existence of multiple chain lengths in the UVCBs such as P-12-0453 and P-12-0433 requires the use of analytical methods that separate congener groups based on retention time in a column and mass spectrum of the respective peaks. Several lines of evidence support the use of a representative SCCP or MCCP product as a surrogate for congener groups present in MCCP or LCCP commercial products, respectively.

Hüttig (2006) and Hüttig and Oehme (2006) reported that most commercial MCCP products were > 60 wt% of the C14 chain-length congener groups and the C15 chain-length congener  groups comprised the majority of the remaining  40 wt%. The authors found < 15 wt% C16 chain-length congener groups present in most commercial MCCP samples and little to no C17 chain-length congener groups. Additional studies have reported that the C14 and C15 chain-length congener groups are the predominant MCCPs present in environmental media and in human breast milk (Bayen et al., 2006; Chen et al., 2011; Reth et al., 2006; Wang et al., 2013). Some variation is possible in commercial products where the C14 and C15 chain-length congener groups may not be the predominant congener groups in a specific MCCP product; however, even in these products, the C14 and C15 chain-length congener groups may serve as reasonable worse case surrogates for the C16-17 chain-length congener groups, due to their greater bioavailability and mobility in environmental media (ECB, 2005).

These analyses, in conjunction with measured or estimated physicochemical and environmental fate properties, allow for the reasonable use of associating commercial products circulating in commerce with CP levels found in environmental media and biota. For example, the experimental observation that MCCPs (C14-17) are abundant in sediment has been explained using known water solubility and vapor pressure values in conjunction with predicted degradation pathways (de Boer, 2010). Therefore, relating one commercial product with other commercial products is reasonable for attributing the hazard characterization to CPs of different sources. EPA/OPPT determined that the key studies for toxicity for both the human health and environmental organism hazard evaluations used one CP commercial product (i.e., Cereclor S52[(R)]). EPA/OPPT determined that the key studies for toxicity for both the human health and environmental organism hazard evaluations used one CP (Cereclor S52(R)) commercial product. Thus, available information (hazard and environmental monitoring data) on one commercial product (Cereclor S52(R)) is used as a representative CP for this assessment. Finally, experimental data on SCCPs show that these shorter chain products are more toxic than the longer chain CPs (e.g., MCCPs and LCCPs). Therefore, when endpoint specific data were lacking for the specific PMNs in this assessment, EPA/OPPT used measured data from SCCPs as surrogates to quantify potential hazards and risks.

USES
INEOS reported four uses for the MCCP PMN (P-12-0453), including:

1) 73.8% as a lubricant in metal working fluids (MWF) (no commercial or consumer uses). The notification substance is blended into the MWFs at 15%.
2) 16.8% as a flame retardant/plasticizer in poly(vinyl chloride) (PVC) resins (no commercial or consumer uses). The notification substance is blended into the PVC resins at 15%.
3) 7.4% as a plasticizer in adhesives (no commercial or consumer uses). The notification substance is blended into the adhesives at 5%.
4) 2% as a lubricant in sealants (no commercial or consumer uses). The notification substance is blended into the sealants at 20%.

INEOS reported one category of use for the LCCP PMN (P-12-0433). This PMN substance is intended for use solely (i.e., 100% of the production volume) as a lubricant in MWF (no commercial or consumer uses). The PMN substance will be used at 15% in the final working formulation.
ENVIRONMENTAL FATE
EPA/OPPT reviewed available information on the environmental fate of MCCPs and LCCPs in different environmental compartments and the properties that control transport in the environment (summarized in Appendix A). In addition, EPA/OPPT reviewed assessments performed by Canada (EC, 2008a) and the EU (EA, 2009; ECB, 2005) to inform its assessment.

ENVIRONMNETAL PERSISTENCE
Abiotic studies have shown that MCCPs and LCCPs are stable to hydrolysis and to direct photolysis in water and air. In laboratory studies using hydrocarbon solvents, CPs were shown to poorly absorb ultraviolet (UV) light and no direct photodegradation was observed. The atmospheric half-life for MCCPs and LCCPs has been estimated at 1 - 2 days (EA, 2009; ECB, 2005), based on estimated values for the second order rate constant for reaction with atmospheric hydroxyl radicals for MCCPs (40-56 wt% Cl) and LCCPs (42-54 wt% Cl) (EA, 2009; ECB, 2005). The persistence of MCCPs increases with carbon chain length and higher chlorine content (EA, 2009; ECB, 2005).

Existing biotic degradation data suggest there are a number of microbial species that are capable of degrading shorter chain, lower chlorinated MCCP congeners. Longer and higher chlorinated chemicals also may be degraded, but at much slower rates (Allpress and Gowland, 1999; Muir, 2010; Omori et al., 1987). The results from laboratory studies of microbial metabolism, using both isolated species and mixed cultures of acclimated microbes, show that MCCPs and LCCPs may be degraded by direct metabolism or co-metabolism by some microbes and microbial consortia in soil, wastewater treatment systems, sediment and other environmental media. Overall, the existing studies suggest that with microbial degradation, dechlorination and carbon chain cleavage may be possible in some media (see Table A-1); however, the degree of degradation is generally low (Allpress and  Gowland, 1999; Muir, 2010; Omori et al., 1987).

In general, MCCP and LCCP congeners with longer chain lengths and higher degrees of chlorination are expected to be persistent or very persistent in some environmental compartments. In contrast, shorter and lesser-chlorinated congeners are likely to degrade rapidly, especially in aerobic environments. Because persistence increases with chain length, LCCPs are generally expected to be more persistent than MCCPs with comparable degrees of chlorination (EA, 2009; ECB, 2005).

Based on the review of available literature and studies submitted by various manufacturers, including confidential business information (CBI) not publicly available, EPA/OPPT's conclusions regarding environmental persistence of MCCPs and LCCPs are consistent with those provided by Canada and the EU.

The Canadian assessment on MCCPs and LCCPs states (EC, 2008a):

      "Information on physical properties of MCCPs, and especially LCCPs, is limited. Values used in this assessment are based on extrapolations mainly from SCCPs or QSARs. The analysis of SCCPs and MCCPs in sediment cores and associated calculations provide strong evidence for the persistence of these substances in the environment. Even though there are no data for persistence of LCCPs in sediment, based on biodegradation data which indicate increasing stability with increasing carbon chain length, it is reasonable to conclude that LCCPs are persistent in sediment."

The EU assessment on MCCPs states (ECB, 2005):

      "No standard ready or inherent biodegradation tests results are available for medium-chain chlorinated paraffins. From the available information, medium-chain chlorinated paraffins can be considered to be not biodegradable in such test systems and so a biodegradation rate MCCPs of 0 day-1 is used in the risk assessment.

      There is evidence that some microorganisms may be capable of degrading MCCPs in the environment in acclimated or co-metabolic systems. The potential for biodegradation appears to increase with decreasing chlorine content. However, it is not possible from the available data to derive rate constants for biodegradation in soil, surface water and sediment systems. As a worst case approach, no biodegradation will be assumed in these media in the PEC calculations.

      Hydrolysis is not expected to be a significant degradation process for medium-chain chlorinated paraffins in the environment. An atmospheric half-life of 1-2 days is estimated for reaction with hydroxyl radicals. A value for the rate constant for the reaction (kOH) of 8 x 10[-12] cm[3] molecule[-1] s[-1] is used for the environmental modelling in the risk assessment."

The UK assessment on LCCPs concluded the following (EA, 2009):

      "Based on the laboratory studies and other data available, LCCPs are unlikely to be readily or inherently biodegradable. Although there is some evidence that they may biodegrade in the environment, it is thought likely that this process will be sufficiently slow that LCCPs meet the P or vP (very persistent) criteria."

EPA/OPPT generally concurs with these characterizations. In the absence of information on specific congener groups and data for MCCP or LCCP products, EPA/OPPT concludes that at least some congener groups present in both MCCP and LCCP products may be persistent to very persistent; with estimated half-lives in air exceeding 2 days and estimated half-lives in water, sediment and soil exceeding 2 months (60 days) (ECB, 2005; EA, 2009). These constituents include C14-17 63% Cl, C14-17 60 - 63% Cl, C14-17 51% and 53 - 56% Cl, C14 60.2% Cl and C18-20 48 - 70% Cl. Further discussion of these findings can be found in Table Apx A-2: Review of MCCP and LCCP Biodegradation Studies.

BIOCONCENTRATION AND BIOACCUMULATION
Recent reviews of the potential for MCCPs and LCCPs to bioaccumulate have shown that, while data are limited, some congener groups are bioaccumulative or very bioaccumulative (EC, 2008a; ECB, 2005; Houde et al., 2008; Thompson and Vaughan, 2014). EPA has identified constituents including C14 51% Cl and C14 63% Cl as potentially bioaccumulative or very bioaccumulative based on experimental data. Further discussion of these findings can be found in Table Apx A-3 in Appendix A.
Based on EPA/OPPT's review of existing studies (Bengtsson et al., 1979; CPC, 1980, 1983a, 1983b; Fisk et al., 1999; Fisk et al., 1998; Houde et al., 2008; Madeley and  Maddock, 1983a, 1983b; Madeley and  Thompson, 1983; Renberg et al., 1986; Thompson et al., 2000), EPA/OPPT concludes that the bioconcentration potential of MCCP and LCCP congener groups varies with the chain lengths and degree of chlorination and species evaluated. Shorter and less chlorinated chemicals are readily taken up by organisms but also may be excreted or degraded after absorption (Arnot, 2013). Longer and more highly chlorinated chemicals are typically not absorbed across cellular membranes and are not accumulated in tissues. Some MCCP chemicals with intermediate chain length and chlorination may be absorbed and retained. The available evidence for MCCP and LCCP congener groups with intermediate chain lengths and chlorination suggests that some may have bioconcentration factors (BCFs) or bioaccumulation factors (BAFs) greater than 1000 or 5000 (EC, 2008a; ECB, 2005, 2008). This suggests that some congener groups in MCCP and LCCP products may be bioaccumulative or very bioaccumulative.

The Canadian assessment on MCCPs and LCCPs states (EC, 2008a):

      "On the basis of the available information, and in particular the field BAF estimates, it is concluded that MCCPs are bioaccumulative substances..."

      "On the basis of the available information, and in particular the BAF model and empirical BMF estimates, it is concluded that C18 - 20 liquid LCCPs are bioaccumulative substances..." [page 27] and "...While there is a lack of empirical bioaccumulation data for LCCPs, the modelling results provided by the Modified Gobas BAF Model - which suggest that of all the LCCPs congeners only liquid C18-20 LCCPs have significant bioaccumulation potential --  are considered credible."

The UK assessment on LCCPs states (EA, 2009):

      "The available data for LCCPs do show that uptake into fish from food occurs in the laboratory, and that this uptake can be significant in some cases. The degree of uptake appears to be highest for the C18 - 20 liquid chlorinated paraffins, but uptake of C>20 liquid chlorinated paraffins has also been demonstrated. The uptake of the highly chlorinated C>20 solid chlorinated paraffins from food appears to be minimal."

EPA/OPPT generally concurs with these characterizations. In the absence of information on specific congener groups and data for MCCP or LCCP products, EPA/OPPT concludes that at least some congener groups present in both MCCP and LCCP products may be bioaccumulative to very bioaccumulative based on multiple lines of evidence, including: Log KOW values, modeled BCFs, laboratory-measured BCFs, field-measured BAFs, field-measured biomagnification factors (BMFs), laboratory-measured biota-sediment accumulation factors (BSAFs) and the presence of MCCPs and LCCPs in human and wildlife biota. EPA has identified constituents including C14 51% Cl and C14 63% Cl as potentially bioaccumulative or very bioaccumulative based on experimental data. EPA has identified constituents including C14 30% Cl through C18 70% Cl as potentially bioaccumulative or very bioaccumulative based on estimated data. Further discussion of these findings can be found in Table Apx A-3: Review of MCCP and LCCP Bioaccumulation Studies and Table_Apx A-4: Estimated BCF/BAF Values for MCCP and LCCP Constituents C14-C20 30 - 70 wt % Cl

ECOLOGICAL HAZARD OVERVIEW
The available ecotoxicity data on MCCPs and LCCPs are summarized in Appendix B, along with the criteria EPA/OPPT used for identifying the highest quality studies. Ecotoxicity studies for MCCPs have been conducted in fish, aquatic invertebrates and plants, sediment and soil invertebrates, and terrestrial plants and invertebrates. Though no avian reproduction studies were available on MCCPs, a high quality study was available on an SCCP product (C10-12, 58 wt% Cl) with similar physicochemical properties to MCCPs and was used for informing EPA/OPPT's hazard evaluation (ECB, 2000).

For LCCPs, ecotoxicity studies were only identified for aquatic invertebrates and vertebrates. No data were available on sediment-dwelling or terrestrial organisms. Overall, the available data on LCCPs were of low quality; therefore, the EPA/OPPT used data on MCCPs to inform its hazard evaluation of LCCPs. This decision was considered a reasonable worst-case scenario because although P-12-0433 contains up to 20 wt% C17, a component of MCCPs (e.g., P-12-0453) contains between 8-18 wt% C17. It is reasonable to assume that C17 congener groups have similar ecotoxicological effects when the wt. % Cl is comparable. EPA/OPPT concludes that the studies summarized in Table 3 were the highest quality for assessing potential hazards in the aquatic, sediment and terrestrial compartments.

Table 3: Summary of Aquatic, Sediment and Terrestrial Ecotoxicity Data for MCCPs and LCCPs

                                Test Substance
                            Test Organism (Species)
                          Test Guideline; Study type
                                 End- point[1]
                                   Value[2]
                                   Reference
                             Aquatic Invertebrates
                       Cereclor S-52 (52 wt% Cl, C14-17)
                                  Water flea
                                (Daphnia magna)
OECD 202, 1984; Acute immobilization test
                                     EC50
                                    0.0059
                                  CPA (1996)
                       Cereclor S-52 (52 wt% Cl, C14-17)
                                  Water flea
                                (Daphnia magna)
OECD 202- Part II, 1984; Reproduction test
                                     NOEC
                                     LOEC
                                     MATC
                                     0.01
                                     0.018
                                     0.013
                       Thompson, Williams et al. (1997)
                        Sediment-Dwelling Invertebrates
                       Cereclor S-52 (52 wt% Cl, C14-17)
                                   Amphipod
                               (Hyalella azteca)
OECD 218- Draft, 2001; 28-day prolonged sediment toxicity study
                                     NOEC
                                     LOEC
                                     MATC
                                      130
                                      270
                                      187
                            Thompson et al. (2002)

                           Terrestrial Invertebrates
                       Cereclor S-52 (52 wt% Cl, C14-17)
                                   Earthworm
                               (Eisenia fetida)
OECD Guideline-Draft, 2000; 28-day reproductive toxicity test
                                     NOEC
                                     LOEC
                                     MATC
                                      79
                                      280
                                      149
                            Thompson et al. (2001d)
                            Terrestrial Vertebrates
                       Commercial CP (58 wt% Cl, C10-12)
                                 Mallard duck
                             (Anas platyrhynchos)
EPA 560/6-82-002; 22-week reproduction test
                                     NOEC
                                     LOEC
                                      168
                                     1000
                                  ECB (2000)
[1]EC50 = concentration that kills/immobilizes 50% of the test animals. NOEC = No observable effect concentration. LOEC = lowest observed effect concentration. MATC = Maximum acceptable toxicant concentration (geometric mean of NOEC and LOEC).
[2]Units are mg/L for aquatic invertebrates, mg/kg dry weight sediment for sediment-dwelling invertebrates; mg/kg dry weight soil for earthworm study; and mg/kg diet for the duck study.

Using the concentrations in the "value" column in Table 3 to represent hazard, EPA/OPPT derived concentrations of concern (COCs) by applying assessment factors of five or ten for acute or chronic exposures, respectively, which account for laboratory variability and represents species sensitivity distributions (following US EPA, 2012). The COCs derived for aquatic-, sediment- and terrestrial-dwelling organisms are explained below and summarized thereafter in Table 4.

The most reliable and acceptable toxicity studies, with the most sensitive endpoints, to assess MCCP and LCCP toxicity to aquatic organisms for MCCPs and LCCPs, are from the CPA (1996) study for acute toxicity and the Thompson et al. (1997) study for chronic toxicity, both in daphnids.

 Acute COC: The 48-hour EC50 value 0.0059 mg/L is divided by an assessment factor of 5 to yield an acute concentration of concern (COC) of 0.00118 mg/L, or 0.001 mg/L, or 1 μg/L (1 ppb).
   Aquatic Acute COC = 1 ppb.
 Chronic COC: The chronic value 0.013 mg/L is divided by an assessment factor of 10 to yield 0.0013 mg/L or 1.3 μg/L or 1.3 ppb.
   Aquatic Chronic COC = 1 ppb.
The most reliable and acceptable value to assess MCCP and LCCP acute toxicity to aquatic sediment invertebrate organisms is based the Thompson et al. (2002) 28-d study in amphipods. The 28-d sediment invertebrate GMATC value of 187 mg/kg dry wt sediment is used to assess hazard. Using methods in US EPA (2012):

 Acute COC: The chronic value 187 mg/kg dry wt. is multiplied by an acute to chronic ratio for invertebrates (10) to yield 1,870 mg/kg dry wt. This value is then divided by an assessment factor of 5 to yield 374 mg/kg dry wt.
   Aquatic Sediment Acute COC = 374 mg/kg dry wt sediment.
 Chronic COC: The 28-d sediment invertebrate GMATC of 187 mg/kg dry wt sediment is divided by an assessment factor of 10 to yield 18.7 mg/kg dry wt sediment.
   Aquatic Sediment Chronic COC = 18.7 mg/kg dry wt sediment.

The most reliable and acceptable value to assess MCPP and LCCP acute toxicity to terrestrial invertebrates is from the Thompson et al. (2001d) study in earthworms. The 28-d terrestrial invertebrate GMATC value of 149 mg/kg dry wt soil from this study will be used. Using methods in US EPA (2012):

 Acute COC: To calculate an acute concern concentration from the chronic value the value 149 mg/kg dry wt, is multiplied by an acute to chronic ratio for invertebrates (10) to yield 1,490 mg/kg dry wt. This value is then divided by an assessment factor of 5 to yield 298 mg/kg dry wt.
   Terrestrial Invertebrate Acute COC = 298 mg/kg dry wt.
 Chronic COC: The 28-d terrestrial invertebrate GMATC of 149 mg/kg dry wt is divided by an assessment factor of 10 to yield 14.9 mg/kg dry wt.
   Terrestrial Invertebrate Chronic COC = 14.9 mg/kg dry wt.

The most reliable and acceptable value to assess MCPP and LCCP acute toxicity to terrestrial vertebrates is based on the SCCP study in ducks reported in ECB (2000). The 22-week terrestrial vertebrate NOEC value of 168 mg/kg dry wt soil from this study will be used. Using methods in US EPA (2012):

 Acute COC: To calculate an acute concern concentration from the chronic value the value 168 mg/kg diet is multiplied by an acute to chronic ratio for invertebrates (10) to yield 1,680 mg/kg diet. This value is then divided by an assessment factor of 5 to yield 336 mg/kg diet.
   Terrestrial Vertebrate Acute COC = 336 mg/kg diet.
 Chronic COC: The 22-week terrestrial vertebrate NOEC of 168 mg/kg diet is divided by an assessment factor of 10 to yield 16.8 mg/kg diet.
   Terrestrial Vertebrate Chronic COC = 16.8 mg/kg diet.

Table 4: COCs for Environmental Toxicity of MCCPs and LCCPs
                                  Compartment
                                 Test organism
                                   Endpoint
                                     Value
                               Assessment factor
                                      COC
                                 Surface water
                                  Water flea
                                     EC50
                                  5.9 ug/L
                                       5
                                   1.2 ug/L

                                  21-day MATC
                                   13 ug/L
                                      10
                                   1.3 ug/L
                                   Sediment
                                   Amphipod
                                     MATC
                                 187 mg/kg dw
                                      10
                          18.7 mg/kg dry wt. sediment
                                  Terrestrial
                                   Earthworm
                                  28-day MATC
                                 149 mg/kg dw
                                      10
                            14.9 mg/kg dry wt. soil

                                 Mallard duck
                                 22-week NOEC
                                168 mg/kg diet
                                      10
                                16.8 mg/kg diet

HUMAN HEALTH HAZARD OVERVIEW
A summary of EPA/OPPT's evaluations on MCCPs and LCCPs is provided in sections 4.1 and 4.2, respectively; individual study reviews are provided in Appendix C.

MCCP HEALTH DATA REVIEW
Based on their low vapor pressure and low water solubility, absorption of MCCPs following inhalation or dermal exposure in humans or animals is expected to be limited. Previous evaluations concluded that absorption by the inhalation and dermal routes of exposure will not exceed 50 or 1%, respectively (ECB 2005; EA 2009). Some MCCPs demonstrated moderate absorption and metabolism following oral exposure in animals. In general, absorption and metabolism are related to the carbon chain length and degree of chlorination; the longer the carbon chain length and the higher the degree of chlorination, the less absorption and metabolism.

No information is available on the toxicity of MCCPs in humans; however, the toxicology of these compounds has been evaluated in experimental animals. Studies in rats and rabbits have shown that MCCPs caused slight skin irritation and have low eye irritation potential (referenced below and in Appendix C). No evidence of skin sensitization was found when tested in guinea pigs. The liver, kidney and thyroid are the target organs of MCCPs in oral repeated dose studies in experimental animals (see Table_Apx C-1 in Appendix C). MCCPs induced increased liver weight, enzyme activity, and histopathological changes at high dose levels. Some of these hepatic effects are likely related to an increase in metabolic demand as an adaptive response, as well as to peroxisome proliferation, which are considered of limited toxicological significant to humans. However, liver necrosis was observed in a 90-day study in rats at 360 mg/kg-bw/day; this effect is considered relevant to humans. The reported effects in the kidney may have been produced by the parent compound or from metabolites. Mechanistic data cannot totally rule out that some kidney effects are relevant to humans. From the data available, a LOAEL of 625 mg/kg-bw/day based on histopathological changes in the kidneys of female rats is identified in a 90-day toxicity study, and a NOAEL of 23 mg/kg-bw/day based on increased kidney weight at 222 mg/kg-bw/day is identified from another 90-day study in rats (CXR, 2005). Repeated dose studies in rats reported some changes in histopathology and hormone levels of the thyroid. However, it may be concluded based on an evaluation of the mechanistic data that the thyroid effects observed in rats is of little relevance to chronic toxicity in humans. This is explained more fully in Appendix C and relates to humans, unlike rodents, possessing a T4-globulin binding protein and thus less susceptible to plasma T4 depletion and hence any resultant thyroid stimulation (as seen in the rodent study).

There is no information on the carcinogenicity of MCCPs; however, carcinogenicity studies on a SCCP and a vLCCP are available. These studies, along with the genotoxicity data on MCCPs, may be used to inform the carcinogenic potential of MCCPs. When administered by gavage, a SCCP (C12, 60 wt% Cl) caused increased incidences of liver tumors in male and female rats, kidney tumors in male rats, and thyroid tumors in female rats. However, based on mechanistic considerations, these tumors are considered to be of little or no relevance to humans (details in ECB, 2008 and in Appendix C). An increased incidence of malignant lymphoma in male mice was reported at the highest dose of 5,000 mg/kg-bw/day in carcinogenicity studies of a vLCCP (C23, 43 wt% Cl) in male and female rats and mice. Because it is unlikely that MCCPs are genotoxic, and the fact that cancer was only observed at the highest dose, the EU (UK 2009) assumed that there was a threshold for this effect in the mice. In addition, there was no increased incidence of malignant lymphoma observed in the carcinogenicity study on an SCCP. Further, MCCPs are non-genotoxic. Therefore, it may be concluded that MCCPs are unlikely to pose a carcinogenic hazard to humans.
A series of range-finding and definitive prenatal developmental and reproductive toxicity studies were conducted in rats and rabbits with MCCPs. These studies were conducted between 1981 and 1986. They appear to be valid toxicity studies, conducted according to the standard methodologies available at the time.

 In several prenatal developmental toxicity studies with MCCPs conducted via gavage, no signs of maternal toxicity were seen at doses of 500 mg/kg-bw/day in rats (the LOAEL was 5,000 mg/kg-bw/day) and 100 mg/kg- bw/day in rabbits (highest dose tested). Likewise, no signs of developmental toxicity were observed at doses as high as 5,000 mg/kg-bw/day in rats and 100 mg/kg-bw/day in rabbits.

A one-generation reproductive toxicity range-finding study exposed rats to MCCP at dietary concentrations of 0, 100, 1000 or 6250 ppm in the diet (equivalent to approximately 0, 6, 62, and 384 mg/kg-bw/day in males and 0, 8, 74, or 463 mg/kg-bw/day in females) (IRDC, 1985 as cited in ECB, 2008). Results showed the following NOAELs/LOAELs: systemic toxicity  -  NOAEL of 74 mg/kg-bw/day based on a LOAEL of 463 mg/kg-bw/day for reductions in body weight gain in females; developmental toxicity  -  NOAEL of 6 or 8 mg/kg-bw/day based on a LOAEL of 62 or 74 mg/kg-bw/day for pup mortality; and reproductive toxicity  -  NOAEL of 384/463 mg/kg-bw/day (highest concentration tested).

Additional studies with MCCPs were conducted in an effort to clarify the possible causes of the hemorrhaging in the pups (see Appendix C for more detailed review). One involved a screening cross-fostering study in rats exposed to 0 or 6,250 ppm MCCP in the diet, or 3,125 mg/kg-bw/day for four weeks (Hart et al., 1985 as cited in ECB, 2008). Results showed that pups from either control or treated animals which were reared with treated dams showed high mortality due to a disruption in a vitamin K-dependent clotting system. Another (0 or 6,250 ppm MCCP in the diet, or 538 mg/kg-bw/day for four weeks) study showed maternal death during parturition due to low levels of vitamin K and related hemorrhaging, suggesting that the act of parturition places dams at higher risk (CXR, 2004 as cited in ECB, 2008). A third study examined the possible role of clotting factors adult rats in an oral gavage study with rats receiving 0, 500 or 1000 mg/kg-bw/day MCCP for 21 days (CXR, 2003 as cited in ECB, 2008) and receiving either a normal diet or a vitamin K-deficient diet. Results showed MCCPs did not adversely affect the blood clotting system in adult females.  It was concluded from these studies that the fetus relies on clotting factors via mother's milk and severe deficiencies in vitamin K levels and related clotting factors in the pups results in hemorrhaging.

These effects in the pups were not seen in a more recent reproductive toxicity study (CXR, 2006 as cited in ECB,2008) conducted in compliance with OECD Guideline 421 (developmental/reproductive screening study); although there were a higher number of animals used and the exposure duration was longer. Rats were administered 0, 300, 600 or 1200 ppm MCCP in the diet (equivalent to 0, 21, 44 or 84 mg/kg-bw/day in males and 0, 23, 47 or 99 mg/kg-bw/day in females). Results showed the following NOAELs/LOAELs: systemic toxicity  -  NOAEL of 47 mg/kg-bw/day based on a LOAEL of 100 mg/kg-bw/day for increases in liver weight in females; developmental toxicity and reproductive toxicity  -  NOAEL of 84/99 mg/kg-bw/day (highest concentration tested).

Internal hemorrhaging was not seen in the adult animals in the range-finding study at doses as high as 384/463 mg/kg-bw/day (6,250 ppm), or in another study in non-pregnant female rats repeatedly exposed to oral gavage doses as high as 1,000 mg/kg-bw/day. However, when dams were exposed to approximately 500 mg/kg-bw/day (6,250 ppm) MCCPs during cohabitation, gestation, and lactation, signs of hemorrhaging were observed in dams that died at the time of parturition. Taken together, the results of these studies suggest that newborns during lactation and pregnant females at the time of parturition are a potentially sensitive subpopulation; with a possible LOAEL for internal hemorrhaging and deaths in pups at an oral dose of 74 mg/kg-bw/day.

No guideline developmental neurotoxicity studies on MCCPs were located. It is not clear if any developmental neurotoxicity endpoints were measured in the available prenatal developmental/reproductive toxicity studies; none were explicitly stated. The only information available regarding behavior during development is from cage-side observations in pups through lactation day 21. In these cases, no dose-related differences were reported in F1 post-weaning appearance or cage-side behaviors. While thyroid hormone induced effects were observed in adults, no data exist for developmental studies. Current studies do not evaluate developmental neurotoxicity following perinatal exposures.

In this assessment, the lowest NOAEL (90-day value of 23 mg/kg-bw/day from the rat study described above; CXR, 2005) was used to assess occupational and non-occupational (i.e., general population) risk of MCCPs.

LCCP HEALTH DATA REVIEW
There is no information on inhalation absorption of v/LCCPs in humans or in animals. Based on their low vapor pressure and water solubility, absorption following inhalation or dermal exposure is expected to be limited. Some absorption and metabolism following oral exposure are possible for LCCPs with shorter carbon chain length and lower degree of chlorination; and some data are reviewed in Appendix C on very long chain chlorinated paraffins (vLCCPs) showing very low absorption via the oral route (less than 1%).

No information is available on the toxicity of LCCPs in humans. Acute oral toxicity data in animals show that v/LCCPs are of very low acute toxicity. Studies in animals have shown that some v/LCCPs may have the potential to cause slight skin irritation and sensitization but no eye irritation potential. The liver is the main target organ of v/LCCPs in repeated dose studies in experimental animals. Inflammatory and necrotic changes of the liver were observed in rats exposed to a C20-30 v/LCCP with 43 wt% Cl at dose levels of 100 mg/kg-bw and above. For another v/LCCP with C20-26 70 wt% Cl, effects in the liver occurred at a very high exposure level of 3,750 mg/kg-bw/day; the NOAEL was 900 mg/kg-bw/day.

As noted above in Section 4.1, an increased incidence of malignant lymphoma in male mice was reported at the highest dose of 5,000 mg/kg-bw/day when tested using a C23 vLCCP with 43 wt% Cl in carcinogenicity studies in male and female rats and mice. vLCCPs are not genotoxic (see review in Appendix C, Section C-2-6), and the fact that cancer was only observed at the highest dose, the EU (UK 2009) assumed that there was a threshold for this effect in the mice. In addition, there was no increased incidence of malignant lymphoma observed in the carcinogenicity study on an SCCP (also discussed above in the MCCP section). It has been concluded that LCCPs are unlikely to pose a carcinogenic hazard to humans (NRC, 2000; Serrone et al., 1987).
Based on the LOAEL (100 mg/kg-bw) of the liver effects in female rats of repeated dose studies,  Health Canada calculated a tolerable daily intake (TDI) of 71 μg/kg-bw/day with LCCPs. Using upper bounding intake estimates ranging from 0.007 μg/kg-bw/day for 60+ age group to 0.024 μg/kg-bw/day for 0.5 years' age group, Environment Canada determined that the exposure levels are 10,000 and 3,000 times lower, respectively, than the TDI.

The National Research Council (NRC, 2000) reviewed the toxicological risks of selected flame retardants, including a vLCCP containing C24 with 70 wt% Cl. Based on the NOAEL of 900 mg/kg-bw/day (liver toxicity), NRC derived an RfD of 0.3 mg/kg-bw/day. Using this RfD and the worst case average daily exposure to be 0.16 mg/kg-bw/day, NRC concluded: "LCCP do not pose a noncancer risk when incorporated into residential furniture at the estimated application levels." Further, it was concluded that: "LCCP are not likely to be a human carcinogen and derivation of a cancer potency factor is unnecessary."

In this assessment, the LOAEL of 100 mg/kg-bw/day from the 90-day and two-year studies described above) was used to assess potential occupational and non-occupational (i.e., general population) risk of LCCPs.

EXPOSURE INFORMATION
EPA/OPPT used the information in this section and our standard PMN approaches to estimate potential worker exposures from activities associated with manufacturing, processing and use of P-12-0453 and P-12-0433. Environmental releases from these activities were also estimated for use in assessing risk to both human health (general population) and the environment (aquatic organisms). In addition, EPA/OPPT reviewed the available information on measured environmental concentrations of MCCPs and LCCPs, which are not normally available for PMNs.
ENVIRONMENTAL MONITORING
For this assessment, environmental monitoring data consisting of measured levels of MCCPs and LCCPs in surface water, sediment and soil were used to characterize potential environmental exposure to MCCPs and LCCPs. These data are not amenable to determining the ultimate release source (i.e., manufacturing, processing, or use) into the environment; however, they provide some insight on the geographical and temporal distribution of MCCPs and LCCPs. Appendix D contains information and data used in this risk assessment.

Studies published between 1980 and 2013 that reported environmental concentrations of MCCPs and/or LCCPs were reviewed for this assessment. Monitoring studies from the early 1980s could not distinguish between the different chain lengths of CPs. The introduction of modern techniques, such as electron capture negative ion mass spectrometry (ECNI-MS) allowed for the detection of specific congeners, although difficulties with these methods have persisted (e.g., detection of low chlorination congeners in samples). Tomy (2010) performed a round robin laboratory study of SCCPs that highlighted the inability of the ECNI-MS method to consistently measure a reference sample, with concentrations varying up to a factor of six. Subsequent work showed that significant errors (up to a factor of ten) could be introduced by the improper selection of the calibration standards (Coelhan et al., 2000). A more recent inter-laboratory study of SCCPs found good agreement amongst the laboratories that used ECNI-MS (Pellizzato et al., 2009), but similar inter-laboratory studies for MCCPs or LCCPs have not been completed (Tomy, 2010).

The majority of the monitoring data were collected in Europe and some more recent monitoring data were collected in China. Over time and across countries, industrial practices and effluent pre-treatment have varied. Some of the monitoring studies only published their final measured concentrations and did not include the details of the analytical techniques and sampling locations. Generally, EPA/OPPT used studies sponsored by the environmental agencies, but full documentation is lacking for even these studies. The industrial sectors studied by other countries also are present in the US, suggesting that conditions in the US may be similar.

The level of detail provided in the studies varied. Some studies provided detailed information regarding sampling locations (e.g., impacted sites), analytical methodology and final sample results including detection limits, quantitation limits and estimated values. In contrast, other studies provided only a summary of the results combined from a number of studies. These summaries also did not provide details of the data analysis to obtain sample results. In addition, certain studies reported concentrations within a given country but did not provide additional details about the exact sampling location. Given the disparate conditions (i.e., number of sites sampled, temporal period over which samples collected, differing analytical methods, etc.) across the data sets, EPA/OPPT was unable to determine a central tendency or distribution for the data sets and a range was used instead. Studies using older analytical techniques that did not distinguish CP congeners were not used in this assessment. Other nations' assessments that used newer, more reliable, analytical techniques were considered.

EPA/OPPT used the following selection criteria to identify the studies included in this assessment:
 Specific mention of MCCP/LCCP chain length;
 Use of modern analytical techniques to distinguish categories of CPs; and
 At a minimum, general information on sampling location.

EPA/OPPT used the monitoring data summarized in Tables 5 and 6 for this assessment. When a limit of detection (LOD) value was reported for non-detectable results, EPA/OPPT used one-half of the LOD value.

Even though the existing monitoring data were limited in quality and quantity and it remains unclear how well the measured data describe the potential range of US MCCP and LCCP use scenarios, EPA/OPPT concluded that the data in Tables 5 and 6 represented the best available monitoring information for MCCPs and LCCPs, respectively. These data provide some evidence that MCCPs and LCCPs are released into the environment; however, these data reflect discrete locations and times and the extent to which they are representative of the overall distribution of MCCPs and LCCPs is unknown.

Table 5: Summary of Measured Concentrations of MCCPs in Environmental Media and Biota.
                                Media Category
                                       n
                                      Min
                                     Unit
                                      Max
                                     Unit
                                  References
                          Surface water (non-marine)
                                      15
                              <2.50 x 10[-10]
                                     mg/L
                                1.49 x 10[-3]
                                     mg/L
Coelhan (2010); EC (2008b); Houde et al. (2008); IPCS (1996); Muir et al. (2003); Petersen et al. (2006)[a]; USEPA (1988)
                                   Sediment
                                 (non-marine)
                                      78
                                2.00 x 10[-3]
                                   mg/kg[b]
                                6.51 x 10[1]
                                   mg/kg dw
Borgen et al. (2003); Chen et al. (2011); EC (2008a); Iozza et al. (2008); IPCS (1996); Nicholls et al. (2001); Petersen et al. (2006); Pribylova et al. (2006); Tomy et al. (1998); Tomy et al. (1999); USEPA (1988)
                               Sediment (marine)
                                      54
                                5.00 x 10[-3]
                                   mg/kg dw
                                1.64 x 10[1]
                                   mg/kg dw
Hüttig et al. (2004); Hüttig and Oehme (2005, 2006); Kemmlein et al. (2002); Muir et al. (2000)
                                    Sludge
                                       9
                                5.00 x 10[-5]
                                   mg/kg[b]
                                9.70 x 10[3]
                                   mg/kg dw
Stevens et al. (2003); Pribylova et al. (2006)
                                     Soil
                                      12
                                2.1 x 10[-6]
                                   mg/kg dw
                                 8.5 x 10[-2]
                                   mg/kg dw
Iozza (2010); Wang et al. (2013)
                                    Biota
                                   (aquatic)
                                      120
                              <2.00 x 10[-7]
                                     mg/kg
                                     2.63
                                   mg/kg ww
Bennie et al. (2000); EC (1993, 2008a); Houde et al. (2008); IVL (2009); Kemmlein et al. (2002); Muir (2010); Muir et al. (2003); Muir et al. (2000); Reth et al. (2005,2006);  Tomy et al., (1999a); USEPA (1988)
                                    Biota
                                 (terrestrial)
                                       8
                                5.00 x 10[-3]
                                   mg/kg ww
                                3.70 x 10[-1]
                                   mg/kg ww
Reth et al. (2006)
[a]Petersen et al. (2006) reported results for two water samples; EPA/OPPT assumed these were non-marine surface water samples.
[b]The weight type was not reported (i.e., wet, dry, or lipid weight).
Notes:
1. All values provided in the table above represent total MCCPs and not individual MCCP isomers.
2. The "n" value represents the number of media-specific MCCP monitoring data values that were compiled from various articles in the raw data table (provided in Appendix D).
3. In some cases, the minimum values in the table are preceded by "<". This indicates that the value reported in article was reported as a non-detect. In such cases, one half of the lowest reported detection limit was compiled as the `minimum' reported monitoring data.
4. dw  -  dry weight and ww  -  wet weight.

Table 6 below summarizes the available environmental monitoring data for LCCPs. Environmental data were available for marine sediment and aquatic invertebrates. Though no data were available for other media categories (e.g., surface water, non-marine sediment, terrestrial invertebrates), limited high quality data (from Table 6) were available for MCCPs which could be used for informing concentrations of LCCPs in the environment. This decision is based on the following information: 1) P-12-0433 commercial products contain up to 20% of C17, an MCCP congener (see Section 1.2 Chemistry), 2) LCCP congener groups are expected to behave in a manner similar to MCCP congener groups with comparable wt% Cl when released to the environment and 3) MCCP and LCCP commercial products have similar uses (see Table 1) and hence may have similar releases at facilities that process and use these chemicals.

Table 6: Summary of Measured Concentrations of LCCPs in Environmental Media and Biota.
                                Media Category
                                       n
                                      Min
                                     Units
                                      Max
                                     Units
                                  References
                               Sediment (marine)
                                       4
                                 1.02x10[-1]
                                   mg/kg dw
                                 4.31x10[-1]
                                   mg/kg dw
Kemmlein et al. (2002)
                                Biota (aquatic)
                                       2
                                 2.80x10[-6]
                                   mg/kg lw
                                 6.90x10[-6]
                                   mg/kg lw
Kemmlein et al. (2002)
Notes:
1. All values provided in the table above represent total LCCP C18-20 and not individual LCCP isomers.
2. The "n" value represents the number of media-specific LCCP C18-20 monitoring data values that were compiled from various articles in the raw data table (provided in Appendix D).
3. dw  -  dry weight and lw  -  lipid weight.

MODELED ENVIRONMENTAL RELEASES
The engineering report which includes more detail on the environmental release assessment including estimates, calculation approaches, basis for estimates and sources used is provided in Appendix E. The following subsections describe the scope, general approach and a summary of key results of the engineering environmental release assessment for P-12-0433 and 0453.
Assessment Scope
P-12-0453 (MCCP)
According to the PMN submission for P-12-0453, the third year production volume for the PMN chemical substances is CBI. INEOS further indicated that the substances is for import only and the intended uses for the PMN substance are split among four uses: flame retardant/plasticizer in polymers, lubricant in metal working fluids (MWFs), lubricant in sealants, and plasticizer in adhesives. EPA's initial hazard review for persistence, bioaccumulation and ecotoxicity indicated the need for the engineering assessment to evaluate potential releases to all media including water, air, landfill and incineration. Based on this information, the following assessment scope was selected.
Approximate Percentage of Production Volume:
Use 1: Flame retardant/plasticizer in polymers  -  17%
Use 2: Lubricant in metalworking fluids  -  74%
Use 3: Lubricant in sealants  -  2%
Use 4: Plasticizer in adhesives 7%

Operations Assessed:
 Formulation of Metalworking Fluids
 Use of Metalworking Fluids
 Plastics Compounding
 Converting of Compounded Plastics into Articles
 Formulation of Adhesives and Sealants
 Use of Adhesives and Sealants
Releases assessed:
 Release to water
 Release to air
 Release to landfill
 Release to incineration

P-12-0433 (LCCP)
According to the PMN submission for P-12-0433, third year production volume for the PMN chemical substances is CBI. INEOS further indicated that the substance is for import only and the only intended uses for the PMN substance is as a lubricant in metal working fluids (MWFs). EPA's initial hazard review for persistence, bioaccumulation and ecotoxicity indicated the need for the engineering assessment to evaluate potential releases to all media including water, air, landfill and incineration. Based on this information, the following assessment scope was selected.
Operations Assessed:
 Formulation of Metalworking Fluids
 Use of Metalworking Fluids
Releases assessed:
 Release to water
 Release to air
 Release to landfill
 Release to incineration

Assessment Approach
The release calculation methodology used in this assessment can be divided into two mains steps:
      1) Estimation of facility throughput of MCCPs/LCCPs in kg/site-yr and kg/site-day
      2) Estimation of the quantities of MCCPs/LCCPs released from the facility to a Publicly Owned Treatment Works (POTW), air, landfill or to incineration.

Facility Throughput
The first option for estimating facility throughput is to use site-specific information from the submitter. However, INEOS did not provide any site-specific information for facility throughputs. In this case, EPA used a generic site approach to estimate an average facility throughput. This value is derived from information on the production volume, estimates of the total number of sites and the days/yr of operation at a given site. Sources of these data include the PMN submission and EPA Generic Scenarios. Appendix E provides details on the basis used to estimate facility throughput values for each of the operations assessed.
Facility Releases (to POTW, air, landfill or incineration)
The first option for estimating facility releases (to POTW, air, landfill or incineration) is to use site-specific release information. However, INEOS did not provide any site-specific information in for these PMN substances. In this situation, EPA typically uses a loss fraction approach. Here, a loss fraction is applied to a facility daily use rate to estimate the amount of MCCPs or LCCPs released to a POTW, air, landfill or incineration. Loss fraction values are based on information in EPA generic scenarios and EPA/OPPT standard release assessment models.
Environmental Release Assessment
EPA's original environmental release assessment prepared in 2012 for these cases took a conservative approach to estimating environmental releases. EPA received additional information pertaining to the environmental release assessment in 2015 and also in 2016 in response to the 12/23/15 FR Notice requesting additional information on chlorinated paraffins PMNs.

In response to the additional information, EPA has expanded its release assessment approach to include additional environmental release assessment scenarios, in addition to the conservative approach from the 2012 analysis (Table 7).

Table 7: Key assumptions in 2012 and 2016 expanded environmental release assessment.
#
Scenario
2012 Scenarios
2016 Expanded Assessment with Additional Release Assessment Scenarios
1
Formulation of Metalworking Fluid
Formulation into Water-Based Metalworking Fluids only
50/50 split between oil-based and water-based metalworking fluids

Equipment Cleaning Waste to uncertain media (POTW, landfill or incineration)
Oil-Based  -  equipment cleaning waste to landfill/incineration

For releases to POTW, assumed no on-site pre-treatment
Water-based  -  on-site pretreatment at 50%, 70% and 99% prior to POTW
2
Use of Metalworking Fluids
Used in Water-Based Metalworking Fluids only
50/50 split between water-based metalworking fluids and oil-based metalworking fluids

All release sources released to POTW or uncertain (POTW, Incineration or Landfill)
Oil-Based fluids  -  per OECD Emission Scenario Document (ESD), only dragout releases to POTW. All other releases to incineration or landfill

Water releases discharged to POTW with no on-site pretreatment
Water-based fluids  -  on-site pretreatment at 50%, 70% and 99% efficiency prior to POTW
3
Plastics Compounding
Equipment cleaning release to water or incineration
Equipment cleaning release to incineration or landfill
4

Plastics Converting
Container cleaning release to uncertain media (POTW, incineration or landfill)
Solid compounded plastic residuals are handled as solid waste and released to incineration or landfill

Equipment cleaning release to uncertain media (POTW, incineration or landfill)
Converted plastic residuals are handled as solid waste and released to incineration or landfill

Dust generation from trimming activities released to air (1%) and landfill (99%)
Dust generation from trimming activities released to POTW or landfill

Scrap material release to POTW or landfill
Scrap material are handled as solid waste and released to incineration or landfill
5

Formulation of Adhesives and Sealants
Water releases discharged to POTW with no on-site pretreatment
On-site pretreatment at 50%, 70% and 99% efficiency prior to POTW

Off-Spec Material released to uncertain media (POTW, incineration or landfill)
Off-Spec material released to incineration or landfill
6

Use of Adhesives and Sealants

Equipment Cleaning and Container Cleaning Waste to uncertain media (POTW, landfill or incineration)
No additional release assessment scenarios were done

Spray application of paints, adhesives and sealants
No change to application method

Summary of Release Assessment
The engineering report with details on estimates, calculations and assumptions is provided in Appendix E. Tables 8 and 9 presents a summary of the environmental release assessment with respect to the potential for release to a POTW for P-12-0453, and 0433, respectively.

Table 8: Summary of environmental release assessment and potential for release to a POTW for P-12-0453.
                                       #
                                   Scenario
                     % of MCCP Throughput released to POTW
1
Formulation of Metalworking Fluids

Original (2012)
                                     4.89%

Oil-Based (2016)
                                      3%

Water-Based, 50% on-site pretreatment (2016)
                                      2%

Water-Based, 70% on-site pretreatment (2016)
                                     1.2%

Water-Based, 99% on-site pretreatment (2016)
                                     0.04%

2
Use of Metalworking Fluids

Original (2012)
                                     92.2%

Oil-Based (2016)
                                     10.7%

Water-based 50% on-site pretreatment (2016)
                                     50.5%

Water-based 70% on-site pretreatment (2016)
                                     30.1%

Water-Based 99% pretreatment (2016)
                                     0.99%

3
Plastics Compounding

Original (2012)
                                      5%

Equipment Cleaning to Incineration or Landfill (2016)
                                      3%

4
Plastics Converting

Original (2012)
                                     5.49%

Solid Wastes from Equipment Cleaning, Container Cleaning, and Scrap Material to Incineration or Landfill; Dust Release to POTW or Landfill (2016)
                                     0.13%

5
Formulation of Adhesives and Sealants

Original (2012)
                                     6.28%

Off-spec to incineration or landfill; 50% on-site pretreatment (2016)
                                     2.62%

Off-spec to incineration or landfill; 70% on-site pretreatment (2016)
                                     1.57%

Off-spec to incineration or landfill; 99% pretreatment (2016)
                                     0.05%

6
Use of Adhesives and Sealants  -  Original (2012)
                                     5.26%

Table 9: Summary of environmental release assessment and potential for release to a POTW for P-12-0433.
                                       #
                                   Scenario
                     % of LCCP Throughput released to POTW
1
Formulation of Metalworking Fluids

Original (2012)
                                      5%

Oil-Based (2016)
                                      3%

Water-Based, 50% on-site pretreatment (2016)
                                      2%

Water-Based, 70% on-site pretreatment (2016)
                                     1.2%

Water-Based, 99% on-site pretreatment (2016)
                                     0.04%

2
Use of Metalworking Fluids

Original (2012)
                                     91.3%

Oil-Based (2016)
                                     10.3%

Water-based 50% on-site pretreatment (2016)
                                     49.5%

Water-based 70% on-site pretreatment (2016)
                                     29.7%

Water-Based 99% pretreatment (2016)
                                     0.99%

Modeled Environmental Concentrations
This section summarizes the approach used to estimate environmental concentrations using the scenarios described above.

Exposure pathways of interest for human health include drinking water, fish ingestion and air stack emissions. For aquatic organisms, the exposure pathway of concern is from direct releases to water. EPA/OPPT assessed each of these pathways by using the ChemSTEER ver. 2 release estimates as inputs to the Exposure and Fate Assessment Screening Tool (E-FAST V2.0) for estimating industrial releases and concentrations in the foregoing exposure pathways.

EPA/OPPT assumed that potential releases to water occurred from indirect discharges to publicly owned treatment works (POTW). The E-FAST V2.0 modeling applied an assumption of 90% removal of MCCPs and LCCPs at the POTW. Water concentrations were estimated using E-FAST V2.0's probabilistic dilution model (PDM), which predicts downstream chemical concentrations from industrial discharges. These values were reported as the central tendency for a median flow site, a low flow site and the lowest seven-day average flow that occurs on average once every ten years (i.e., 7Q10). These estimated water concentrations were compared to the COC of 1 ug/L (rounded from the 1.2 ug/L presented in Table 4) for chronic aquatic invertebrates. Air stack emissions were estimated using generic scenarios, which assumed inhalation exposures occurring 100 meters downwind of a facility. It was further assumed that the CPs are degraded during incineration (ICPS, 1996), the preferred method for disposal of MCCPs (UK, 2008). In this report, EPA/OPPT estimated an incineration removal efficiency of 99.9% to calculate inhalation exposures to the general population downwind from incinerators that receive MCCPs/LCCPs in waste. EPA/OPPT used these estimated values for calculating human health and environmental risks of P-12-0453 and P-12-0433.

The results of the E-FAST V2.0 modeling are provided in Appendix F. Table 9 presents the values used in the risk assessment. As explained in the footnotes in Table 9, the values represent reasonable worst-case scenarios based on the processing and use scenarios presented in Table 7. However, these estimates require consideration of two important caveats: (1) limited environmental monitoring data are available and (2) MCCPs and LCCPs are expected to partition to particulates and sediment; however, E-FAST V2.0 models do not account for this partitioning.

                   Table 10: E-FAST Modeling Values Used[1]
                                   Scenario
                           Water Release - Human[2]
                            Air Release - Human[2]

                    Water Release  -  Aquatic Organisms[3]

                                Drinking Water
                                (mg/kg-bw/day)
                                Fish Ingestion
                                (mg/kg-bw/day)
                            Stack Air ADR (mg/m[3])
                          Fugitive Air ADR (mg/m[3])
                        Range of Concentrations (ug/L)
                              Days of exceed-ance
                                   P-12-0453
                Formulation of MWFs (Proc1  -  Four Scenarios)
Oil-Based
                               6.60 x 10[-][1]
                                2.17 x 10[+1]
                               1.58 x 10[-][2]
                               8.88 x 10[-][3]
                              799-5808 (29,600)*
                                      NA
Water-Based, 50%
                               3.40 x 10[-][1]
                                1.14 x 10[+1]
                               8.30 x 10[-][3]
                               4.70 x 10[-][4]
                                 2.3-16.4 (84)
                                      239
Water-Based, 70%
                               2.00 x 10[-][1]
                                 6.65 x 10[0]
                               4.92 x 10[-][3]
                               4.70 x 10[-][4]
                                1.4-9.9 (50.3)
                                      239
Water-Based, 99%
                               6.59 x 10[-][3]
                               2.20 x 10[-][1]
                               3.30 x 10[-][4]
                               8.88 x 10[-][3]
                                .045-0.33 (1.7)
                                      67
                     Use of MWFs (Use1  -  Four Scenarios)
Oil-Based
                               1.13 x 10[-][3]
                                2.20 x 10[-2]
                               9.30 x 10[-][5]
                                  No releases
                                0.47-5.9 (53)*
                                      210
Water-Based, 50%
                               5.67 x 10[-][3]
                                1.10 x 10[-1]
                               4.26 x 10[-][5]
                                  No releases
                                 2.1-27 (242)
                                      244
Water-Based, 70%
                               3.38 x 10[-][3]
                                6.60 x 10[-2]
                               2.54 x 10[-][5]
                                  No releases
                                1.3-16.1 (145)
                                      239
Water-Based, 99%
                               1.11 x 10[-][4]
                               2.17 x 10[-][3]
                               8.40 x 10[-][7]
                                  No releases
                               0.042-0.53 (4.8)
                                      70

Formulation: Plastics compounding (Proc2)
                               1.10 x 10[-][1]
                                 3.78 x 10[0]
                               2.75 x 10[-][3]
                               1.50 x 10[-][2]
                               0.053-0.39 (1.97)
                                      41
Use: Plastics converting (Use2)
                               8.06 x 10[-][5]
                                2.45 x 10[-3]
                                1.30 x 10[-4]
                               3.69 x 10[-][2]
                               0.021-0.66 (3.6)
                                      104
       Formulation of Adhesives and Sealants (Proc3  -  Four Scenarios)
Off-spec to incineration or landfill; 50%
                               2.85 x 10[-][3]
                               9.44 x 10[-][2]
                               1.41 x 10[-][3]
                                  No releases
                                3.5-25.3 (129)
                                      200
Off-spec to incineration or landfill; 70%
                               1.71 x 10[-][3]
                               5.66 x 10[-][2]
                               1.39 x 10[-][3]
                                  No releases
                                 2.1-15.2 (77)
                                      199
Off-spec to incineration or landfill; 99%
                               5.71 x 10[-][2]
                                 1.89 x 10[0]
                               1.35 x 10[-][3]
                                  No releases
                               0.069-0.51 (2.6)
                                      82

Use of adhesives and sealants (Use3)
                               4.35 x 10[-][3]
                               7.50 x 10[-][2]
                               1.50 x 10[-][5]
                               1.60 x 10[-][1]
                                 0.26-3.0 (31)
                                      186
                                   P-12-0433
                 Formulation of MWFs (Use1  -  Four Scenarios)
Oil-Based
                               1.23 x 10[-][2]
                                3.80 x 10[-1]
                               3.50 x 10[-][4]
                                1.91 x 10[-3]
                               14.9-108.6 (554)*
                                      NA
Water-Based, 50%
                               6.41 x 10[-][3]
                                2.00 x 10[-1]
                               1.60 x 10[-][4]
                                6.60 x 10[-4]
                                0.17-1.2 (6.2)
                                      41
Water-Based, 70%
                               3.78 x 10[-][3]
                                1.20 x 10[-1]
                                1.0 x 10[-][4]
                                6.60 x 10[-4]
                               0.097-0.71 (36.1)
                                      31
Water-Based, 99%
                               1.25 x 10[-][4]
                               3.87 x 10[-][3]
                               1.58 x 10[-][5]
                               6.60 x 10[-][2]
                              0.0033-0.024 (0.12)
                                       0

                                0.15-1.1 (5.7)*
                                      NA

 Use of MWFs
Oil-Based
                               9.69 x 10[-][4]
                                1.76 x 10[-2]
                                8.42 x 10[-5]
                                  No releases
                                 0.4-5.1 (45)
                                      203
Water-Based, 50%
                                4.68 x 10[-3]
                               8.52 x 10[-][2]
                                3.49 x 10[-5]
                                  No releases
                                1.9-24.4 (220)
                                      243
Water-Based, 70%
                                2.81 x 10[-3]
                                5.11 x 10[-2]
                                2.09 x 10[-5]
                                  No releases
                                1.2-14.7 (132)
                                      237
Water-Based, 99%
                               9.45 x 10[-][5]
                                1.72 x 10[-3]
                                7.00 x 10[-7]
                                  No releases
                               0.039-0.49 (4.4)
                                      66
1 Taken from Appendix F. Values represent the highest concentrations/estimated doses (reported as the lifetime average daily dose, or LADD) for chronic (i.e., repeated exposure scenarios) for human health.
2 Estimated exposure values were corrected for absorption by the oral (50% absorption) and inhalation (50% absorption) routes of exposure (ECB 2005; EA 2009).
3 For PMNs, environmental risk was evaluated by performing a PDM as described above and in the E-FAST Manual (2007). The ranges encompass concentrations from the central tendency for a median flow site (e.g., 2.3 ug/L) up to the central tendency for a low flow site (e.g., 16.4 ug/L)  -  this example was taken from the third row (water-based, 50%) under P-12-0453 under the column heading "Range of Concentrations". The central tendency was calculated using the harmonic mean flow. The value in parentheses represents the 7Q10 (e.g., 84 ug/L) value normally used to determine potential chronic risk to aquatic organisms.
NA indicates that there are not a sufficient number of days of release to calculate the days of exceedance where a chronic CoC was exceeded.
* The concentrations are based on a 24-hour average surface water concentration alone as the number of days of release was insufficient to model chronic surface water exposures.

OCCUPATIONAL EXPOSURE ESTIMATES

Assessment Scope
The operations assessed in the occupational exposure assessment were the same as for the modeled environmental release assessment describe above in Section 5.2. EPA estimates the number of workers potentially exposed and the potential for inhalation exposure (to vapors, particulates, aerosol/mists) and dermal exposure to the hands (through contact with liquids or solids). The scope of the occupational exposure assessment is summarized below.

	Operations Assessed:
               Formulation of Metalworking Fluids
               Use of Metalworking Fluids
               Plastics Compounding
               Converting of Compounded Plastics into Articles
               Formulation of Adhesives and Sealants
               Use of Adhesives and Sealants
	Occupational Exposures assessed:
               Number of workers potentially exposed
               Days per year for exposure
               Inhalation exposure (to vapors, particulates, aerosols, or mists) without use of respiratory protection
               Dermal exposure to the hands (through contact with liquids or solids) without the use of protective gloves

Assessment Approach
Number of workers

The approach involves estimating the number of sites and then estimating the number of workers potentially exposed per site. More details on how the approaches were applied to make estimates are provided in Apx E.

Number of sites

Site-Specific: Information provided to EPA in the PMN submission was used when available to estimate the number of sites for a given operation.

Generic: In the absence of data and where the operation takes place at sites not under the submitter's control, EPA used a generic approach combining data from the PMN submission and data in generic scenarios. This involved three key parameters:

 Total Production Volume for the chemical (provided to EPA in the PMN submission)
 % of production volume for a given use (e.g., 74% for metalworking fluids)
 Estimate of the facility throughput (kg/site-yr) for a given operation described above in Section 5.2.2.

Days/yr of Potential Exposure

EPA uses data provided in the PMN submission and generic scenarios as a basis to estimate days/yr of potential exposure. An often used default is to assume 250 days per year based on 50 weeks and 5 days per week.

Inhalation Exposure

Quantitative Approach: The first option for estimating inhalation exposure is using monitoring data for the chemical being assessed or for analogous chemicals. These data may be provided in the PMN submission, available in generic scenarios or obtained from other published sources. In this assessment, such data were augmented with EPA assessment policy guidance to assess potential inhalation exposure. Table 11 summarizes the sources utilized for each operation assessed.
Personal Protective Equipment - EPA does not account for protection from use of respiratory protection in its screening-level assessments of inhalation exposure.

Table 11: Data sources for inhalation exposures.
                                   Operation
                   Source of Inhalation exposure assessment
Formulation of Metalworking Fluids (Proc1)
Negligible per EPA assessment policy for non-volatile liquids
Use of Metalworking Fluids (Use1)
Monitoring data for oil mist exposure in OECD Emission Scenario Document on Use of Metalworking Fluids
PVC Compounding (Plastics Compounding) (Proc2)
Monitoring data for MCCP vapor exposure in published source
Converting of Compounded PVC into Articles (Use2)
Monitoring data for MCCP vapor exposure in published source
Formulation of Adhesives and Sealants (Proc3)
Negligible per EPA assessment policy for non-volatile liquids
Use of Adhesives and Sealants (Use3)
Standard EPA model for spray application of paints

Summary of Occupational Exposure Assessment
Table 12 below presents a summary of the occupational exposure estimates for P-12-0453 and 0433. No additional occupational exposure assessment work was performed for the scenarios in this 2016 assessment; the estimates presented below are the same as for the previous EPA risk assessment.

Table 12: Summary of Occupational Exposure Estimates Used.
                                  Scenario[1]
                               Route of Exposure

                                  Inhalation
                                   (mg/day)
                                    Dermal
                                   (mg/day)
                                   P-12-0453
PROC1: Formulation of MWFs
                                    N/A[2]
                                 450  -  2,200
PROC2: PVC compounding
                                 0.030  -  4.4
                                     2,200
PROC3: Formulation of adhesives and sealants
                                    N/A[2]
                                 660  - 2,200
USE1: Use of MWF
                                  2.0  -  7.1
                                 450  -  5,000
USE2: PVC converting
                                   12  -  22
                                    N/A[2]
USE3: Use of adhesives and sealants
                                      23
                                      530
                                   P-12-0433
PROC1: Formulation of MWFs
                                    N/A[2]
                                 450  -  2,200
USE1: Use of MWFs
                                  2.0  -  7.1
                                 450  -  3,900
[1]The following represent the estimated number of sites, workers per scenario and exposure over the course of the stated number of days: P-12-0453 = PROC1: 59 sites, 472 workers and 84 days/year; PROC2: 8 sites, 192 workers and 126 days/year; PROC3: 3 sites, 66 workers and 200 days/year; USE1: 207 sites, 9,936 workers and 247 days/year; USE2: 8 sites, 384 workers and 250 days/year; USE3: 58 sites, 2,784 workers and 250 days/year; P-12-0433 = PROC1: 3 sites, 24 workers and 27 days/year; USE1: 4 sites, 192 workers and 247 days/year.
[2]Not applicable, the use category does not result in exposures that are relevant for this route.

CONSUMER EXPOSURE ESTIMATES
INEOS did not identify consumer uses in its PMN applications for P-12-0453 and P-12-0433; therefore, EPA/OPPT did not perform an assessment for these types of exposures.
RISK ASSESSMENT

ENVIRONMENTAL ASSESSMENT
PMN risk assessments typically use modeled exposure values because, by definition, new chemical substances are not circulating in US commerce. However, for MCCPs and LCCPs, measured environmental data are available for some locations in the US and abroad. Though these data are not specific to P-12-0453 and P-12-0433, the data contain MCCP and LCCP congener groups that may be present in the PMN substances. However, EPA/OPPT used modeled exposure values as the principal source for its decision-making because the modeled exposure values were generated using exposure scenarios that are representative of the types of uses and releases that may occur with P-12-0453 and P-12-0433. In contrast, the measured environmental data are generally not amenable for identifying the types of uses or releases from which the measured congeners originated. Therefore, EPA/OPPT used these measured data as supporting information, along with modeled exposure values, to calculate potential environmental risks using the risk quotient (RQ) method.

The RQ method integrates the results of exposure and ecotoxicity data (USEPA, 1998).

An RQ is defined as:

               RQ = Environmental Concentration / Effect Level

where, the environmental concentration represents measured (see Tables 5 and 6) or estimated (see Table 10) values for each compartment (i.e., water, sediment and soil) and the effect level represents the COC for aquatic, benthic, or terrestrial species (see Table 4).

An RQ greater than one serves as a benchmark for identifying whether aquatic concentrations of P-12-0453 and P-12-0433 may present a risk to aquatic- and sediment-dwelling organisms.

Risk Estimates Using Environmental Monitoring Concentrations
The RQs shown in Table 13 suggest that measured concentrations of MCCPs and LCCPs in water and sediment may present an unreasonable risk of acute and chronic injury to aquatic organisms and may present an unreasonable risk of chronic injury to sediment-dwelling organisms. However, several limitations must be noted about the monitoring studies and the level of uncertainty that they contribute to the basis of these findings. First, the reported concentrations represent minimum and maximum values that span, at a minimum, several orders of magnitude and translate to RQs of less than one (i.e., low risk finding) or greater than one (i.e., risk finding), respectively. Second, the temporal and geographical distributions of these data, along with the different types of uses and releases that may have served as the originating sources, make it impossible to describe the central tendency of these data. Finally, the frequency and magnitude of locations with relevant use and release scenarios to the PMN substances, which may result in environmental releases of MCCPs or LCCPs that exceed the relevant COCs, is unknown. In addition to these general limitations, there are specific limitations and uncertainties that preclude using these values as the sole source from which to inform potential environmental concentrations and risks that may result from the specific uses and releases associated with P-12-0453 and P-12-0433.

Table 13: Risk Quotients Calculated from Environmental Monitoring Data for Surface Water, Sediment and the Terrestrial Environment.

                          Environmental Concentration
                                 Effect Level
                                  (i.e., COC)
                                      RQs
Acute Risk
Aquatic Species
                    < 2.50x10[-10] to 1.49x10[-3] mg/L
                                  0.001 mg/L
                         < 2.50x10[-7] to 1.49[1]
Chronic Risk
Aquatic Species
                    < 2.50x10[-10] to 1.49x10[-3] mg/L
                                  0.001 mg/L
                           < 2.50x10[-7] to 1.49
Chronic Risk
Sediment-dwelling Species
Non-marine Environment
                             0.002 to 65 mg/kg dw
                                 18.7 mg/kg dw
                              1.07x10[-4] to 3.5
Chronic Risk
Terrestrial Species
                              Insufficient Data
                               14.9 mg/kg dw[2]
                                Not calculated
[1]Bolded values represent those that may present an unreasonable risk of injury.
[2] The COCs for terrestrial invertebrates and vertebrates were 14.9 mg/kg dw and 16.8 mg/kg diet, respectively. Since these values were comparable, EPA/OPPT used the lowest value as a potential means for calculating RQs for this compartment, once relevant data are available.

For surface water, EPA/OPPT based the aquatic risk findings for MCCPs and LCCPs on the highest concentration reported by Petersen et al. (2006). These authors collected two surface water samples from an undisclosed location(s) in Norway and measured the concentration of MCCP congener groups (i.e., C14-17). The authors reported a concentration of 1.49 x 10[-3] mg/L for MCCP congener groups in one sample; however, a numerical value was not provided for the second sample, rather the distribution of congener groups was displayed in a bar graph. Based on the ordinate scale, the concentration of MCCP congener groups in the second sample was greater than zero, but less than 5.0 x 10[-4] mg/L. Of the monitoring studies reviewed by EPA/OPPT (see Appendix D), the Petersen et al. (2006) value of 1.49 x 10[-3] is the only surface water concentration that resulted in an RQ greater than one. All other surface water concentrations are at least one order of magnitude below 1.49 x 10[-3] mg/L (i.e., RQs < 1).

For sediment concentrations, EPA/OPPT reviewed multiple studies, some of which reported values that exceeded the COC. Nicholls et al. (2001) reported the most relevant data for P-12-0453 and P-12-0433. These authors measured concentrations of MCCPs at locations in the United Kingdom where specific industries were known to employ MCCPs in the use categories identified for the PMN substances (e.g., lubricant in MWFs, plasticizer in PVC resins, and lubricant in sealants). Eight locations were sampled at three distances downstream (i.e., 100 meters, 300 meters, and 1-2 kilometers) from the respective sewage treatment works. At four of the locations, at least one of the sampled downstream values exceeded the COC (i.e., RQs > 1, risk finding). Though it is not possible to parse out the contribution of specific uses to the measured values, these data support that releases occur at locations with relevant uses to the PMN substances, which contribute to the environmental load of MCCP congener groups and in some cases result in RQs greater than one.

For soil concentrations, EPA/OPPT was unable to calculate RQs for terrestrial organisms due to the absence of relevant measured data from biosolid-amended soils. Though Iozza (2010) and Wang et al. (2013) reported measured levels of MCCPs in soil, the samples were collected from sites in remote alpine locations or industrialized areas, respectively. These data are relevant for assessing airborne deposition of MCCPs/LCCPs; however, the reported concentrations are of questionable relevance with informing concentrations of MCCPs/LCCPs that may occur in biosolid-amended agricultural soils.

Due to the foregoing limitations and resulting uncertainties with the measured environmental data, EPA/OPPT used these data in a limited capacity for estimating potential risks associated with the use categories identified for P-12-0453 and P-12-0433. Specifically, these data were used as supporting information to inform the relevant pathways for estimating potential releases from relevant use categories for the PMN substances. A summary of the estimated release values and associated RQs that EPA/OPPT used as a key basis for evaluating the potential risks of P-12-0453 and P-12-0433 is presented in the following section.

Risk Estimates Using Modeled Exposures
The RQs shown in Table 14 suggest that, using the conventional EPA PMN method of using the 7Q10 flow scenario to represent the modeled concentration in water, all of the intended processes and uses for P-12-0453 and P-12-0433 are expected to result in releases to surface water at concentrations that may present an unreasonable risk of injury to aquatic organisms.

Importantly, the Federal Register notice in 2015 requesting additional information regarding the use/removal/environmental release of CPs from the uses evaluated in this assessment resulted in significant changes for some water release/risk assessment calculations. Use of the submitted industry information pertaining to pre-treatment of MWFs (water -based vs. oil-based assumptions) resulted in declines in the 7Q10 estimate and the resulting estimate for risk. This was particularly evident when the median stream flow scenario is included in the range of risk estimates. For example, for P-12-0453, use of MWFs (Use1), the original EPA 2012 assessment predicted a median flow value of 0.47 ug/L and a 7Q10 flow of 53 ug/L; resulting in RQs of 0.47  -  53. When the water-based scenario is used (99% removal on-site, prior to release to POTW), the resulting range in RQs is 0.048  -  4.2.

It is noteworthy that these estimated concentrations are within the range of measured surface water concentrations reported for MCCP congener groups (Table 5). Though there is uncertainty whether the form (i.e., dissolved or particle bound) of MCCP impacts the aquatic toxicity, the estimated values suggest that either form may exist. The median stream flow estimates are all below the reported water solubility for P-12-0453 and slightly above or below the water solubility reported for P-12-0433 (Table 1). Since the available aquatic toxicity data support that dissolved MCCP congener groups cause toxicity, the estimated water concentration values suggest that the risk finding for these scenarios are plausible. Some low stream flow and most 7Q10 flow scenarios estimate water concentrations that far exceed the estimated water solubility of all three PMN substances. Under these scenarios, the MCCP or LCCP congener groups would likely be bound to particulates and would eventually settle out in sediment. Nicholls et al. (2001) provided support for this pathway and showed that sediment concentrations of MCCP congener groups generally increased with distance downstream from the source outfall. Based on the foregoing information, EPA/OPPT concludes the following: 1) the estimated water concentrations were adequate for determining that environmental releases of P-12-0453 and P-12-0433 may present a risk of injury to aquatic organisms; and 2) it was unnecessary to estimate sediment concentrations of CP congener groups because any potential risks to sediment-dwelling organisms would be managed by addressing the risks identified for aquatic organisms.

Table 14: Risk Assessment of Aquatic Organisms Using Modeled Exposures[1]
                                   Scenario
                   Estimated Water Concentrations (ug/L)[2]

                                      RQs

                                Median Stream
                                 Flow Scenario
                           Low Stream Flow Scenario
                                     7Q10
                                 Flow Scenario
                              Days of exceedance

                                   P-12-0453
                Formulation of MWFs (Proc1  -  Four Scenarios)
Oil-Based
                                      799
                                     5808
                                    29,600
                                      NA
                                  799-29,600
Water-Based, 50%
                                      2.3
                                     16.4
                                      84
                                      239
                                    2.3-84
Water-Based, 70%
                                      1.4
                                      9.9
                                     50.3
                                      239
                                   1.4-50.3
Water-Based, 99%
                                     0.045
                                     0.33
                                      1.7
                                      67
                                   0.045-1.7
                     Use of MWFs (Use1  -  Four Scenarios)
Oil-Based
                                     0.47
                                      5.9
                                      53
                                      210
                                    0.47-53
Water-Based, 50%
                                      2.1
                                      27
                                      242
                                      244
                                    2.1-242
Water-Based, 70%
                                      1.3
                                     16.1
                                      145
                                      239
                                   1.3-16.1
Water-Based, 99%
                                     0.042
                                     0.53
                                      4.8
                                      70
                                   0.042-4.8

Plastics compounding (Proc2)
                                     0.053
                                     0.39
                                     1.97
                                      41
                                  0.053-1.97
Plastics converting (Use2)
                                     0.021
                                     0.66
                                      3.6
                                      104
                                   0.021-3.6
       Formulation of Adhesives and Sealants (Proc3  -  Four Scenarios)
Off-spec to incineration or landfill; 50%
                                      3.5
                                     25.3
                                      129
                                      200
                                    3.5-129
Off-spec to incineration or landfill; 70%
                                      2.1
                                     15.2
                                      77
                                      199
                                    2.1-77
Off-spec to incineration or landfill; 99%
                                     0.069
                                     0.51
                                      2.6
                                      82
                                   0.069-2.6

Use of adhesives and sealants (Use3)
                                     0.26
                                      3.0
                                      31
                                      186
                                    0.26-31
                                   P-12-0433
                Formulation of MWFs (Proc1  -  Four Scenarios)
Oil-Based
                                     14.9
                                     108.6
                                      554
                                      NA
                                   14.9-554
Water-Based, 50%
                                     0.17
                                      1.2
                                      6.2
                                      41
                                   0.17-6.2
Water-Based, 70%
                                     0.097
                                     0.71
                                     36.1
                                      31
                                  0.097-36.1
Water-Based, 99%
                                    0.0033
                                     0.024
                                     0.12
                                       0
                                  0.033-0.12

                                     0.15
                                      1.1
                                      5.7
                                      NA
                                   0.15-5.7
                     Use of MWFs (Use1  -  Four Scenarios)
Oil-Based
                                      0.4
                                      5.1
                                      45
                                      203
                                    0.4-45
Water-Based, 50%
                                      1.9
                                     24.4
                                      220
                                      243
                                    1.9-220
Water-Based, 70%
                                      1.2
                                     14.7
                                      132
                                      237
                                    1.2-132
Water-Based, 99%
                                     0.039
                                     0.49
                                      4.4
                                      66
                                   0.039-4.4
[1]Taken from full model run of summary data presented in Appendix E.
[2]For PMNs, EPA/OPPT evaluated potential environmental risks by performing a PDM as described above and in the "Exposure and Fate Assessment Screening Tool (E-FAST) Version 2.0 Documentation Manual (2007)", available at: http://www.epa.gov/tsca-screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-2014-documentation-manual

HUMAN HEALTH
EPA/OPPT assessed potential risks to workers and the general population by calculating margins of exposure (MOE). This approach is performed according to the following equation:

          MOE = Point of Departure (POD) / Estimated human exposure

For the PODs, EPA/OPPT identified effect levels from three oral repeated dose toxicity studies, which served as the basis for calculating human equivalent doses (HEDs) (CXR 2005; NTP 1986). In the first study, CXR (2005) reported a NOAEL of 23 mg/kg-bw/day based on increased kidney weight at 222 mg/kg-bw/day in male rats exposed through diet for 90 days to an MCCP congener group (C14-17, 52 wt% Cl). In the second and third studies, NTP (1986) reported LOAELs of 100 mg/kg-bw/day based on granulomatous inflammation of the liver in female rats administered an LCCP congener (C23, 43 wt% Cl) by gavage for 5 days/week for 12 months or two years.

Using the effect levels of 23 mg/kg-bw/day (for the MCCP PMN: P-12-0453) or 100 mg/kg-bw/day (for the LCCP PMN [P-12-0433]), EPA/OPPT performed route-to-route extrapolations to develop HEDs for inhalation and dermal exposures in workers and for inhalation and oral exposures in the general population. EPA/OPPT did not assess oral exposures for workers, due to the unlikely nature of exposures occurring by this route. The respective HEDs served as the PODs for calculating MOEs, along with the previously reported estimated human exposure values for workers (Table 12) and the general population (Table 10).
EPA/OPPT compared the MOEs to a benchmark value that consisted of a composite of three possible uncertainty factors (UFs): intraspecies variability (UFH; default value = 10), interspecies variability (UFA; default value = 10), and LOAEL-to-NOAEL extrapolation uncertainty (UFL; default value =10). The LOAEL-to-NOAEL extrapolation was only used for P-12-0433 (LCCP). The UFH and UFA may each be subdivided to account for toxicokinetics (TK; default value = 3.16) and toxicodynamics (TD; default value = 3.16). When effect levels from experimental animal studies are converted to HEDs, EPA/OPPT's default approach is to reduce the TK sub factor of UFA to 1 (i.e., UFA = TK x TD = 1 x 3.16 ≈ 3).

EPA/OPPT interprets MOEs that were equal to or below a benchmark value (e.g., MOE < 1000 [UFH x UFA x UFL = 1000]) as an indication that the scenario(s) may present an unreasonable risk of injury to human health, whereas MOEs that were above the benchmark value is an indication of a low risk finding. When data are available that reduce these uncertainties, the benchmark MOEs may be lower. In the following sections, more detailed descriptions are provided on: 1) converting effect levels to route- and exposure-specific HEDs; 2) determining the appropriate UFs for the benchmark value, and 3) evaluating risk estimates for workers and the general population.

Workers
EPA/OPPT performed route-to-route extrapolations to convert the oral NOAEL of 23 mg/kg-bw/day (i.e., MCCP congener groups) and the oral LOAEL of 100 mg/kg-bw/day (i.e., LCCP congener) to HEC values for inhalation exposures to workers (i.e., HECINHAL-WORKER) using the following equation (ECHA, 2012):

HECINHAL-WORKER = NOAELORAL or LOAELORAL x (1 / sRVRAT) x (ABSORAL-RAT / ABSINHAL- HUMAN) x (sRVHUMAN / wRV)

where,

      NOAELORAL = 23 mg/kg-bw/day (MCCP), or LOAELORAL = 100 mg/kg-bw/day (LCCP)
      sRVRAT = rat standard respiratory volume for 8-hours = 0.38 m[3]/kg bw
      ABSORAL-RAT = percent absorption by the oral route in rats = 50%
      ABSINHAL-HUMAN = percent absorption by inhalation in humans = 50%
      sRVHUMAN = human standard respiratory volume for 8-hours = 6.7 m[3]
      wRV = worker respiratory volume for 8-hours = 10 m[3]

For the oral NOAEL of 23 mg/kg-bw/day and the oral LOAEL of 100 mg/kg-bw/day, the HECINHAL-WORKER values equal 41 mg/m[3] and 176 mg/m[3], respectively.

EPA/OPPT calculated the HED values for dermal exposures to workers (i.e., HEDDERM-WORKER) based on the following equation:

HEDDERM-WORKER = NOAELORAL x (ABSORAL-RAT / ABSDERMAL- HUMAN) x (BWHUMAN / BWRAT)[1/4]

where,

      NOAELORAL = 23 mg/kg-bw/day (MCCP), or LOAELORAL = 100 mg/kg-bw/day (LCCP)
      ABSORAL-RAT = percent absorption by the oral route in rats = 50%
      ABSDERM-HUMAN = percent absorption by the dermal route in humans = 1%
      BWRAT = rat bodyweight = 0.250 kg
      BWHUMAN = human bodyweight = 71.8 kg

The resulting HEDDERM-WORKER values equal 4,734mg/kg-bw/day for MCCP congener groups and 20,583 mg/kg-bw/day for the LCCP congener.

EPA/OPPT used the foregoing HED values to inform the appropriate application of UFs to derive benchmark values. For MCCP congener groups and the LCCP congener, a benchmark value of 30 or 300 was applied, respectively. These values consisted of the following individual UFs. A default UFH of 10 was applied to each benchmark value, due to the absence of experimental data to inform the TK and TD sub factors of this UF. A reduced UFA of 3 was applied to each benchmark value, which accounted for a TK sub factor of 1 after converting the effect levels to HEDs (i.e., the use of allometric scaling). The UFA of 3 accounted for the remaining uncertainty associated with TD variability. A default UFL of 10 was only used for the benchmark value compared to the MOE derived from an LCCP congener because the underlying study reported a LOAEL, not a NOAEL. Thus, the acceptable MOE would be 30 (10 times 3) for MCCPs and 300 (10 times 10 times 3) for the LCCP.

EPA/OPPT used the HECINHAL-WORKER and HEDDERM-WORKER values for calculating the respective MOEs using the estimated exposure values presented in Table 12. As shown in Tables 15-18, the MOEs for P-12-0453 and P-12-0433 all exceeded the respective benchmark values, which indicate a finding of low risk to workers for the processes and uses evaluated in this assessment.

When evaluating the risks of workers from exposure to MCCPs based on the available repeated-dose toxicology studies, the EU's draft Risk Assessment Report (RAR) on MCCPs concluded that except metal working fluids (MWF) use,  "There is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied already" (ECB, 2008).

Table 15: Occupational MOEs for P-12-0453 (MCCP): Inhalation Exposures (Hazard POD [HEC] = 41 mg/m[3])[1]
Scenario
                                Exposure Route
                           Modeled Exposure (mg/day)
                         Absorption Inhalation Human
                   Inhalation Rate, Workers, Eight
Hour/Day
                     Estimated Inhalation Exposure (mg/m3)
              Inhalation MOE (Risks Identified for MOEs < 30)
Proc 2
Inhalation
                                     0.03
                                      0.5
                                      10
                                    0.0015
                                     27333

                                      4.4
                                      0.5
                                      10
                                     0.22
                                      186
Use 1
Inhalation
                                       2
                                      0.5
                                      10
                                      0.1
                                      410

                                      7.1
                                      0.5
                                      10
                                     0.355
                                      115
Use 2
Inhalation
                                      12
                                      0.5
                                      10
                                      0.6
                                      68

                                      22
                                      0.5
                                      10
                                      1.1
                                      37
Use 3
Inhalation
                                      23
                                      0.5
                                      10
                                     1.15
                                      36
[1] Proc2 = Processing 2 = compounding of plastic products, Use 1 = use of metal working fluids, Use 2 = converting plastic products. Use 3 = use of adhesives and sealants.

Table 16: Occupational MOEs for P-12-0453 (MCCP): Dermal Exposures (Hazard POD [HED] = 4734 mg/kg-bw/day)
Scenario
                                Exposure Route
                           Modeled Exposure (mg/day)
                                BW
(E-FASTV2)
                           Absorption Dermal Human
                   Estimated Dermal Exposure (mg/kg-bw/day)
               Dermal MOE  (Risks Identified for
MOEs < 30)
Proc 1
Dermal
                                      450
                                     71.8
                                     0.01
                                     0.06
                                     75534

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
Proc 2
Dermal
                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
Proc 3
Dermal
                                      660
                                     71.8
                                     0.01
                                     0.09
                                     51500

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
Use 1
Dermal
                                      450
                                     71.8
                                     0.01
                                     0.06
                                     75534

                                     5000
                                     71.8
                                     0.01
                                     0.70
                                     6798
Use 3
Dermal
                                      530
                                     71.8
                                     0.01
                                     0.07
                                     64132
[1] Proc1 = Processing 1= Formulation of metal working fluids, Proc 2 = Processing 2 = compounding of rubber products, Use 1 = use of metal working fluids.

Table 17: Occupational MOEs for P-12-0433 (LCCP): Inhalation Exposures (Hazard POD [HEC] = 176 mg/m[3])[1]
Scenario
                                Exposure Route
                           Modeled Exposure (mg/day)
                         Absorption Inhalation Human
                  Inhalation Rate,  Workers, Eight
Hour/Day
                     Estimated Inhalation Exposure (mg/m3)
             Inhalation MOE  (Risks Identified for MOEs < 300)
Commercial Use of MWF
Inhalation
                                       2
                                      0.5
                                      10
                                      0.1
                                     1760

                                      7.1
                                      0.5
                                      10
                                     0.36
                                      489

Table 18: Occupational MOEs for P-12-0433 (LCCP): Dermal Exposures (Hazard POD [HED] = 20,583 mg/kg-bw/day)
Scenario
                                Exposure Route
                           Modeled Exposure (mg/day)
                                BW
(E-FASTV2)
                           Absorption Dermal Human
                   Estimated Dermal Exposure (mg/kg-bw/day)
               Dermal MOE  (Risks Identified for
MOEs < 300)
Processing MWF
Dermal
                                      450
                                     71.8
                                     0.01
                                     0.06
                                    343050

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     66397
Commercial Use of MWF
Dermal
                                      450
                                     71.8
                                     0.01
                                     0.06
                                    343050

                                     3900
                                     71.8
                                     0.01
                                     0.54
                                     38117

General Population
EPA/OPPT converted the oral NOAEL of 23 mg/kg-bw/day (i.e., MCCP congener groups) and the oral LOAEL of 100 mg/kg-bw/day (i.e., LCCP congener) to HED values for oral exposures to the general population (i.e., HEDORAL-GENPOP) using the following equation:

HEDORAL-GENPOP = NOAELORAL x (ABSORAL-RAT / ABSORAL- HUMAN) x (BWHUMAN / BWRAT)[1/4] x (5 days / 7 days)[a]

where,

      NOAELORAL = 23 mg/kg-bw/day (MCCP); or LOAELORAL=100 mg/kg-bw/day (LCCP)
      ABSORAL-RAT = percent absorption by the oral route in rats = 50%
      ABSORAL-HUMAN = percent absorption by the oral route in humans = 50%
      BWRAT = rat bodyweight = 0.250 kg
      BWHUMAN = human bodyweight = 71.8 kg
      [a]A duration-specific adjustment was applied because the animals were gavaged five days per week.

For the oral NOAEL of 23 mg/kg-bw/day and the oral LOAEL of 100 mg/kg-bw/day, the HEDORAL-GENPOP values equal 67.6 mg/kg-bw/day and 294 mg/kg-bw/day, respectively.

For assessing inhalation exposures to the general population, EPA/OPPT performed route-to-route extrapolations to convert the oral NOAEL of 23 mg/kg-bw/day (i.e., MCCP congener groups) and the oral LOAEL of 100 mg/kg-bw/day (i.e., LCCP congener) to HED values for inhalation exposures to the general population (i.e., HEDINHAL-GENPOP) using the following equation (ECHA, 2012):

HECINHAL-GENPOP = (NOAEL ORAL) x (1/sRVrat) x (ABSoral-rat/ABSinh-human) x
(5 days/7 days)[a]

where,

NOAELORAL = 23 mg/kg-bw/day (MCCP); or LOAELORAL=100 mg/kg-bw/day (LCCP)

sRVrat = rat standard respiratory volume for 24-hours = 1.15 m[3]/kg-bw

ABS ORAL-RAT = percent absorption by the oral route in rats = 50%
ABS INHAL-HUMAN = percent absorption by inhalation in humans = 50%
[a]A duration-specific adjustment was only applied because the animals were gavaged five days per week

For the oral NOAEL of 23 mg/kg-bw/day and the oral LOAEL of 100 mg/kg-bw/day, the HEDINHAL-GENPOP values equal 14.3 mg/m[3] and 62.1 mg/m[3], respectively.

The same benchmark values of 30 or 300 were used for evaluating the general population MOEs. These benchmark values consisted of the same individual UFs and rationale discussed previously for workers.

EPA/OPPT used the HEDORAL-GENPOP and HECINHAL-GENPOP values for calculating the respective MOEs using the estimated exposure values presented in Table 10. Tables 19 and 20 present risk estimates for all drinking water and fish ingestion scenarios for P-12-0453 and -0433.  There are three scenarios (out of 44) for which there is a potential risk to the general population due to fish ingestion using the E-FAST modeling results. These scenarios were further evaluated using the highest measured values of MCCPs in fish. The calculations, assumptions and results are also presented in Table 19. Using these measured values and high-end (95[th] percentile) fish intake assumptions, results in MOEs greater than 30 (i.e., 10,400). There are no risk concerns from exposure to the PMNs via drinking water.

Though not used for determining risk, the three modeled fish ingestion scenarios where estimated risks were found are all for the MCCP (P-12-0453) and represent exposure from formulation of MWFs: from the oil-based assumption, the 50% pre-treatment assumption and the 70% pre-treatment assumption. There was no estimated risk from the MWF formulation with 99% the pre-treatment assumption. As with the environmental assessment, use of the submitted industry information pertaining to pre-treatment of MWFs (water -based vs. oil-based assumptions) resulted in declines in risk estimation, and, in this case (fish ingestion from formulation of MWFs), a scenario in which there was no estimated risk (i.e., 99% pre-treatment prior to release to a POTW).

Table 19: General Population MOEs for P-12-0453 (MCCP):  Drinking Water/Fish Ingestion Risk Estimates (Hazard POD [HED] = 67.6 mg/kg-bw/day)
Scenario
                                Exposure Routes
                            Exposure (mg/kg bw/day)
                            Absorption Oral Human
                       Estimated Exposure (mg/kg bw/day)
                                      MOE
                         (Risks Identified if <30)
Formulation of MWFs Oil-Based (Proc1)
Drinking Water Ingestion
                                   6.60E-01
                                      0.5
                                    0.3300
                                      205

Fish Ingestion (b)[a]
                                     0.013
                                      0.5
                                    0.0065
                                    10,400

Fish Ingestion (m)[b]
                                   2.17E+01
                                      0.5
                                    10.8500
                                       6
MWF Formulation Water Based 50% Pretreatment (Proc1)
Drinking Water Ingestion
                                   3.40E-01
                                      0.5
                                    0.1700
                                      398

Fish Ingestion (b)
                                     0.013
                                      0.5
                                    0.0065
                                    10,400

Fish Ingestion (m)
                                   1.14E+01
                                      0.5
                                    5.7000
                                      12
MWF Formulation Water Based 70% Pretreatment (Proc1)
Drinking Water Ingestion
                                   2.00E-01
                                      0.5
                                    0.1000
                                      676

Fish Ingestion (b)
                                     0.013
                                      0.5
                                    0.0065
                                    10,400

Fish Ingestion (m)
                                   6.65E+00
                                      0.5
                                    3.3250
                                      20
MWF Formulation Water Based 99% Pretreatment (Proc1)
Drinking Water Ingestion
                                   6.59E-03
                                      0.5
                                    0.0033
                                     20516

Fish Ingestion
                                   2.20E-01
                                      0.5
                                    0.1100