Premanufacture Notification Number: P-12-0282-0284
Office of Chemical Safety and Pollution Prevention
Premanufacture Notification Number: P-12-0282-0284
Office of Chemical Safety and Pollution Prevention
United States
Environmental Protection Agency
United States
Environmental Protection Agency

                       TSCA New Chemicals Review Program
                      Standard Review Risk Assessment on

                      Medium-Chain Chlorinated Paraffins
                          (PMN P-12-0282, P-12-0283)

                                      and

                       Long-Chain Chlorinated Paraffins
                                (PMN P-12-0284)

This assessment was conducted under EPA's TSCA Section 5 New Chemicals 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 hazard and exposure information on P-12-282 and P-12-0283 (MCCPs), and P-12-0284 (LCCP), EPA/OPPT concludes the following pertaining to the potential manufacturing, processing and use of these PMN substances:
 Occupational Exposures: Given the assumptions, data and scenarios evaluated in this assessment, there were no risks found for workers from inhalation or dermal exposures for the LCCP PMN (P-12-0284), or for workers from dermal exposures to the two MCCP PMNs (P-12-0282-0283). There was one of six occupational inhalation exposure scenarios for the MCCP PMN substances which suggested risk. The single scenario was for the use as a plasticizer in paints, sealants and adhesives (0.5% of production volume); and only for the high-end exposure estimate. The high-end value is a modeled estimate. The low-end value (which shows no risk) is based on the highest measured occupational exposure value from an occupational exposure study.
 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 (all three PMNs/scenarios). For one MCCP and the LCCP, there were no risks found to humans from the environmental releases from exposure via fish ingestion. However, for one of the two MCCPs (P-12-0282), there was one scenario (1 out of 76 scenarios evaluated) where potential risk to the general population due to fish ingestion were identified using the E-FAST modeling results. This scenario was further evaluated using the highest measured values of MCCPs in fish. Using this measured values and high-end (95[th] percentile) fish intake assumptions, there was no risk identified. There were no risks found to humans from environmental releases via inhalation exposures from emissions from facilities (all three PMNs).

 Consumer Exposures (from one use for the two MCCP PMNs): There was one scenario (do-it-yourself changing of motor oil) for the MCCPs for which a risk estimate was determined. Given the assumptions, data and scenario evaluated in this assessment, there were no risks found to humans from this use.

 Environmental Assessment:
 Using the conventional EPA PMN method of estimating water concentrations, all of the intended processes and uses for P-12-0282 and 0283; and all intended uses for P-12-0284 (but not for one intended process for P-12-0284), are expected to result in releases to 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, and there was one scenario in which the estimated risk range suggested low risk (the LCCP P-12-0284, formulation of metal working fluids, water-based assumption with 99% on-site removal).
 Using available measured concentrations of MCCP and LCCP congener groups in the environment as supporting information, the PMN substances:
 Are expected to partition to sediment and may partition to soil through land application of biosolids, and
 May be released to the environment at water concentrations that may present an unreasonable risk following acute and chronic exposures to aquatic organisms.
 May be released to the environment resulting in sediment concentrations that may present an unreasonable risk following chronic exposures to sediment organisms.

 PBT Assessment: The PMN substances may be very persistent and very bioaccumulative.
 TABLE OF CONTENTS
TABLE OF CONTENTS	4
1	INTRODUCTION	7
1.1	PMNs RECEIVED	7
1.2	CHEMISTRY	7
1.3	USES	10
2	ENVIRONMENTAL FATE	11
2.1	ENVIRONMENTAL PERSISTENCE	11
2.2	BIOCONCENTRATION AND BIOACCUMULATION	13
3	ECOLOGICAL HAZARD OVERVIEW	14
4	HUMAN HEALTH HAZARD OVERVIEW	17
4.1	MCCP HEALTH DATA REVIEW	17
4.2	LCCP HEALTH DATA REVIEW	20
5	EXPOSURE INFORMATION	21
5.1	ENVIRONMENTAL MONITORING	21
5.2	MODELED ENVIRONMENTAL RELEASES	24
5.3	EXPOSURE ESTIMATES	38
5.3.1	OCCUPATIONAL EXPOSURE ESTIMATES	38
5.3.2	CONSUMER EXPOSURE	43
6	RISK ASSESSMENT	43
6.1	ENVIRONMENTAL ASSESSMENT	43
6.1.1	Risk Estimates Using Environmental Monitoring Data	44
6.1.2	Risk Estimates Using Modeled Exposures	46
6.2	HUMAN HEALTH	49
6.2.1	Workers	50
6.2.2	General Population (from Environmental Releases)	54
6.2.3	Consumer	64
7	CONCLUSIONS	65
8	REFERENCES	66
9	APPENDICES	81
Appendix A	ENVIRONMENTAL FATE AND BIOACCUMULATION STUDY SUMMARIES	82
A-1	ENVIRONMENTAL PERSISTENCE	82
A-1-1	Abiotic Degradation	82
A-1-1-1	Fate in Air	82
A-1-2	Biodegradation	83
A-1-2-1	Fate in Wastewater Treatment	83
A-1-2-2	Fate in Surface and Groundwater	84
A-1-2-3	Fate in Soil	84
A-2	BIOCONCENTRATION AND BIOACCUMULATION	89
Appendix B	ECOTOXICITY STUDY SUMMARIES	99
B-1	MCCP ECOTOXICITY DATA	99
B-1-1	Acute Fish Toxicity	99
B-1-2	Acute Aquatic Invertebrate Toxicity	100
B-1-3	Algae Toxicity	103
B-1-4	Chronic Fish Toxicity	104
B-1-5	Chronic Aquatic Invertebrate Toxicity	107
B-1-6	Chronic Aquatic Sediment Invertebrate Toxicity	110
B-1-7	Avian Toxicity	112
B-1-8	Terrestrial Invertebrate Toxicity	113
B-1-9	Terrestrial Plant Toxicity	114
B-1-10	Conclusions	115
B-2	LCCP Ecotoxicity Data	116
B-2-1	Acute Fish Toxicity	116
B-2-2	Acute Aquatic Invertebrate Toxicity	117
B-2-3	Aquatic Plant Toxicity	118
B-2-4	Chronic Fish Toxicity	119
B-2-5	Chronic Aquatic Invertebrate Toxicity	119
B-2-6	Chronic Aquatic Sediment Invertebrate Toxicity	123
B-2-7	Avian Toxicity	123
B-2-8	Terrestrial Invertebrate Toxicity	123
B-2-9	Terrestrial Plant Toxicity	123
B-2-10	Conclusions	123
Appendix C	HUMAN HEALTH HAZARD STUDY SUMMARIES	126
C-1	MCCP Health Data Review	126
C-1-1	Metabolism	127
C-1-2	Acute Toxicity	127
C-1-3	Irritation and Sensitization	127
C-1-4	Repeated-dose Toxicity	127
C-1-5	Genotoxicity	129
C-1-6	Carcinogenicity	129
C-1-7	Developmental Reproductive Toxicity Review	133
C-2	LCCP Health Data Review	139
C-2-1	Metabolism	140
C-2-2	Acute Toxicity	140
C-2-3	Irritation and Sensitization	140
C-2-4	Repeated-dose Toxicity	140
C-2-5	Genotoxicity	141
C-2-6	Carcinogenicity	141
C-2-7	Developmental Reproductive Toxicity Review	141
Appendix D	ENVIRONMENTAL MONITORING DATA	145
D-1	MCCP MONITORING DATA	145
D-1-1	Surface Water	145
D-1-2	Sediment	147
D-1-3	Biosolids and Soil	156
D-1-4	Biota	156
LCCP MONITORING DATA	159
Appendix E	ENGINEERING (ChemSTEER) REPORTS ON P-12-0282, P-12-0283 and P-12-0284	160
Appendix F	EXPOSURE SCENARIO ESTIMATES	232
Appendix G	SUPPLEMENTAL INFORMATION	240
   INTRODUCTION
PMNs RECEIVED
Dover Chemical Corporation (Dover) submitted three 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-12-0282 and P-12-0283) of varying chain lengths with the formula CxH(2x-y+2)Cly and x equaling 14 to 16 and y equaling 6 to > 24 or long-chain chlorinated paraffins (LCCPs; P-12-0284) 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 basic information Dover supplied on these three PMNs (two MCCPs and one LCCP).

Table 1: Identification, Production Volume and Use for P-12-0282 to 0284
                                      PMN
                                 Chemical Name
                             1[st] Year Production
                                  Volume (kg)
                                     Uses
                                    Log Kow
                               Water Solubility
                                   P-12-0282
                            Alkanes, C14-16, chloro
                                    (MCCP)
                                  11,749,910
See below for generic uses
                                   4.70 (E)
                              < 0.03 mg/L (E)
                                   P-12-0283
                              Tetradecane, chloro
                                    (MCCP)
                                   3,779,281
See below for generic uses
                                   4.70 (E)
                              < 0.03 mg/L (E)
                                   P-12-0284
                              Octadecane, chloro
                                    (LCCP)
                                    45,500
100% as a lubricant in metal working fluid
                                   8.00 (E)
                             < 0.005 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 importance of carbon chain length coupled with the degree/percent of chlorination in all of the chlorinated paraffins (CPs) are important in understanding this assessment.
CHEMISTRY
Shown below are the structures and chlorine content of each of the three PMNs. P-12-0282 contains chain lengths of between C14-16 and both P-12-0283 and P-12-0284 represent C14 and C18 chain length congener groups, respectively.

P-12-0282: The average molecular formula would range from C14H27Cl3 (at ~30% chlorination) to C16H18Cl16 high wt (at ~ 70% chlorination).

P-12-0283: The average molecular formula would range from C14H27Cl3 (at ~30% chlorination) to C14H16Cl14 (at ~ 75% chlorination).

P-12-0284: The chlorinated products would range from C18H35Cl3 (at ~30% chlorination) to C18H20Cl18 (at ~70% chlorination).

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, C 18-20
 Very long chain CPs (vLCCPs, 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 Log KOW (logarithm of octanol:water partition coefficient). All three PMNs in this assessment are liquids with chlorination levels of between 30 to 75%. EPA/OPPT used the physicochemical properties listed in Table 2 for informing its evaluation of P-12-0282, 0283 and 0284.

 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

> 10

 [a]Source: European Union Risk Assessment Report (ECB) of MCCP (ECB, 2008)
 [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'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 log KOW between 5.5 and 8.2 and then chose to use log KOW = 7 as a representative log KOW for MCCP 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-12-0282 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)]). 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
Dover reported up to six uses for the two MCCP PMNs (P-12-0282 and P-12-0283), including:

      1) 43% as a flame retardant/plasticizer in polymers (no consumer use). Typical concentration in the plastic is 12-30%.
      2) 30% as a lubricant in MWFs (no consumer use). The notification substance is blended into the MWFs at 5-10%.
      3) 24% as a flame retardant/plasticizer in rubber. Typical concentration in the rubber is 1 - 10%, with a median value of 5.5%.
      4) 2% as lubricants in automotives. 20% consumer uses. The notification substance is blended into the lubricant at 4%.
      5) 0.5% as a plasticizer in solvent based paints, adhesives and sealants. The paints are specialty paints for applications where weather resistant coatings are needed, such as steel construction, industrial flooring, road marking, and swimming pools. The notification substance is blended into the paints at 5-15%. Consumer use as sealants in windows is 0.1%.
      6) 0.5% a flame retardant/waterproofer to textiles (no consumer use). The notification substance products are added at 5% of the textile coating finishing solution.

For the LCCP, P-12-0284, 100% of the use is as a lubricant in metalworking fluids.

Table 3 provides the listed trade names, range of chlorination and percent PMN substance in the final use products.

Table 3: Trade Names, Percent Chlorination and PMN Concentration in Final Use Products
                                      PMN
                                  Trade Names
                             Percent Chlorination
                         Percent PMN in final Product
                                   P12-0282
                                    (MCCP)
Variations of PAROIL, CHLOROWAX, KLORO.
Also  -  P152, AO52, OA50-60, X1045, X1052
                                     30-70
                                     5 -30
                                   P-12-0283
                                    (MCCP)
Variations of PAROIL, DO, P358, Doverguard.
Also  -  P10NR, AO63NR, Entech Blend, Militec-1, US Pack Blend, HWDO8110
                                     30-75
                                     5-30
                                   P-12-0284
                                    (LCCP)
DO 8707, DO 8110
                                     30-70
                                     5-10
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 European Union (EU) (EA, 2009; ECB, 2005) to inform its assessment.
ENVIRONMENTAL 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 Appendix A, Table_ApxA-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 less 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.

Canada's assessment (EC, 2008a) states:

      "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 (ECB, 2005) states:

      "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 (EA, 2009) concluded:

      "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 MCCP products may be persistent to very persistent; with estimated half-lives in air exceeding two days and estimated half-lives in water or sediment exceeding two months (60 days) (ECB, 2005; EA, 2009). These constituents include C14-17 63% Cl, C 14-17 60 - 63% Cl, C 14-17 51% and 53 - 56% Cl and 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 varies with the chain lengths and degree of chlorination within the CP mixture 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 (EC, 2008a) on MCCPs and LCCPs states:

      "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 (EA, 2009) on LCCPs states:

      "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-12-0284 does not contain any C17 congener groups, it is reasonable to assume that C17 and C18 congener groups have similar ecotoxicological effects when the wt. % Cl is comparable. EPA/OPPT concludes that the studies summarized in Table 4 were the highest quality for assessing potential hazards in the aquatic, sediment and terrestrial compartments.

Table 4: 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 4 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 USEPA, 2012). The COCs derived for aquatic-, sediment-, and terrestrial-dwelling organisms are explained below and are summarized in Table 5.

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 USEPA (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 is used. Using methods in USEPA (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 in the diet from this study is used. Using methods in USEPA (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 5: COCs for Environmental Toxicity of MCCPs and LCCPs.
                                  Compartment
                                 Test organism
                                   Endpoint
                                     Value
                               Assessment factor
                        Concentration of Concern (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/d from the rat study described above; CXR, 2005) will be 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 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/day) for liver effects in female rats of repeated dose studies, Health Canada calculated a tolerable daily intake (TDI) of 71 ug/kg-bw/day with LCCPs. Using upper bounding intake estimates ranging from 0.007 ug/kg-bw/day for 60+ age group to 0.024 ug/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), the 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/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 study with a vLCCP described above will be used to assess occupational and non-occupational (i.e., general population) risk of LCCPs.

EXPOSURE INFORMATION
EPA/OPPT used the information in this section and standard PMN approaches to estimate potential worker exposures from activities associated with manufacturing, processing and use of P-12-0282, 0283 and 0284. 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 6 and 7 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, as described in greater detail below.

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 6 and 7 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 6: Summary of Measured Concentrations of MCCPs in Environmental Media and Biota
                                Media Category
                                       n
                                      Min
                                     Unit
                                      Max
                                     Unit
                                  References
                          Surface water (non-marine)
                                      15
                               <2.50x10[-10]
                                     mg/L
                                 1.49x10[-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
                                 2.00x10[-3]
                                    mg/kg**
                                 6.51x10[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
                                 5.00x10[-3]
                                   mg/kg dw
                                 1.64x10[1]
                                   mg/kg dw
Hüttig et al. (2004); Hüttig and Oehme (2005, 2006); Kemmlein et al. (2002); Muir et al. (2000)
                                    Sludge
                                       9
                                 5.00x10[-5]
                                   mg/kg **
                                 9.70x10[3]
                                   mg/kg dw
Stevens et al. (2003); Pribylova et al. (2006)
                                     Soil
                                      12
                                 2.1 x 10[-6]
                                   mg/kg dw
                                  8.5x10[-2]
                                   mg/kg dw
Iozza (2010); Wang et al. (2013)
                                    Biota
                                   (aquatic)
                                      120
                               <2.00x10[-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); USEPA (1988); Tomy et al., (1999a)
                                    Biota
                                 (terrestrial)
                                       8
                                 5.00x10[-3]
                                   mg/kg ww
                                 3.70x10[-1]
                                   mg/kg ww
Reth et al. (2006)
[a]Peterson (2006) reported results for 2 water samples; EPA/OPPT assumes these are 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 MCCP 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 7 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-12-0284 does not contain any C17 congener groups; however, it is reasonable to assume that C17 and C18 congener groups have similar ecotoxicological effects when the wt% Cl is comparable, 2) LCCPs are also expected to behave in a manner similar to the MCCPs when released to the environment, and 3) MCCPs and LCCPs have similar uses (see Table 1) and hence may have similar releases at facilities that process and use these chemicals.

 Table 7: 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-12-0282, -0283 and -0284.

Assessment Scope
P-12-0282 (MCCP)
According to the PMN submission for P-12-0282, the third year production volume for the PMN chemical substances is estimated to be 11,749,910 kg/yr. Dover further indicated that the intended uses for the PMN substance are split among the following uses: flame retardant/plasticizer in polymers (43%), lubricant in metal working fluids (MWFs) (30%), lubricant in automotive (2%), flame retardant/plasticizer in rubber (24%), plasticizer in solvent based paints, adhesives, and sealants (0.5%) and flame retardant/waterproofer in textiles (0.5%). 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.
Total Production Volume: 11,749,910 kg/yr
Use 1: Flame retardant/plasticizer in polymers 5,052,461 kg/yr
Use 2: Lubricant in metalworking fluids 3,524,973 kg/yr
Use 3: Lubricant in automotive 234,998 kg/yr
Use 4: Flame retardant/plasticizer in rubber 2,819,978 kg/yr
Use 5: Plasticizer in solvent based paints, adhesives, and sealants 58,750 kg/yr
Use 6: Flame retardant/waterproofer in textiles 58,750 kg/yr

Operations Assessed:
 Manufacture at Dover site in Dover, OH and Hammond Works site in Hammond, IN
 Plastics Compounding (Processing 1; "Proc1")
 Converting of Compounded Plastics into Articles ("Use1")
 Rubber Compounding (Processing 2, "Proc2")
 Converting of Compounded Rubber into Articles ("Use2")
 Formulation of Metalworking Fluids (Processing 3, "Proc3")
 Use of Metalworking Fluids ("Use3")
 Formulation of Engine Lubricants (Processing 4, "Proc4")
 Use of Engine Lubricants ("Use4")
 Formulation of Paints, Adhesives and Sealants (Processing 5, "Proc5")
 Application of Paints, Adhesives and Sealants ("Use5")
 Textile Finishing ("Use6")

Releases assessed:
 Release to water
 Release to air
 Release to landfill
 Release to incineration

P-12-0283 (MCCP)
According to the PMN submission for P-12-0283, the third year production volume for the PMN chemical substances is estimated to be 3,779,281 kg/yr. Dover further indicated that the intended uses for the PMN substance are split between flame retardant/plasticizer in polymers (43%), lubricant in metal working fluids (MWFs) (30%), lubricant in automotive (2%), flame retardant/plasticizer in rubber (24%), plasticizer in solvent based paints, adhesives, and sealants (0.5%) and flame retardant/waterproofer in textiles (0.5%). 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.
Total Production Volume: 3,779,281 kg/yr
Use 1: Flame retardant/plasticizer in polymers 1,625,091 kg/yr
Use 2: Lubricant in metalworking fluids 1,133,784 kg/yr
Use 3: Lubricant in automotive 75,586 kg/yr
Use 4: Flame retardant/plasticizer in rubber 907,027 kg/yr
Use 5: Plasticizer in solvent based paints, adhesives, and sealants 18,896 kg/yr
Use 6: Flame retardant/waterproofer in textiles 18,896 kg/yr

Operations and Releases Assessed:  Same as P-12-0282 described above.

P-12-0284 (LCCP)
According to the PMN submission for P-12-0284, the third year production volume for the PMN chemical substances is estimated to be 45,500 kg/yr. Dover further indicated that the only intended use 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.
Total Production Volume: 45,500 kg/yr
Use: Lubricant in metalworking fluids 45,500 kg/yr
Operations Assessed:
 Manufacture at Dover site in Dover, OH
 Formulation of Metalworking Fluids (Processing, "Proc")
 Use of Metalworking Fluids ("Use")
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 main 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. For PMNs P-12-0282 to 0284, Dover provided site-specific information for the manufacturing sites in Dover, OH (all three PMNs) and Hammond, IN (the two MCCP PMNs).
For the other operations assessed, site-specific throughput data for MCCPs/LCCPs were not available. 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. For these PMN substances, the submitter provided site-specific release information for their manufacturing sites in Dover, OH and Hammond, IN. This information was used in the assessment.
For the other operations assessed, site-specific release information was not available. 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/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.
EPA 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 previous analysis (Table 8).

Table 8: Key assumptions in the 2012 and 2016 expanded environmental release assessment (All for MCCPs; LCCPs are Only for Scenarios 6 and 7).
                                       #
                                   Scenario
                                2012 Scenarios
     2016 Expanded Assessment with Additional Release Assessment Scenarios
1
Manufacture at Dover Site in Dover, OH and Hammond Works site in Hammond, IN
Once per year equipment cleaning to incineration or landfill
No additional release assessment scenarios were done
2
Plastics Compounding

Shipping Container residue discharged to POTW after cleaning
Shipping Container residue collected then picked up on quarterly (4x per year) or monthly (12x per year) basis for treatment

Equipment cleaning release to water or incineration
Equipment cleaning release to incineration or landfill
3

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
4
Rubber Compounding
Shipping Container residue discharged to POTW after cleaning
Shipping Container residue collected then picked up on quarterly (4x per year) or monthly (12x per year) basis for treatment

Equipment cleaning release to uncertain media (POTW, incineration or landfill)
Equipment cleaning release to incineration
5
Rubber Converting
Multiple release sources with some potential for release to POTW
Converting more specifically defined as cutting/trimming into articles. Only waste source is scrap material sent to incineration or landfill
6
Formulation of Metalworking Fluid
Formulation into Water-Based Metalworking Fluids only
50/50 split between oil-based and water-based metalworking fluids

Shipping Container residue discharged to POTW after cleaning
Shipping Container residue collected then picked up on quarterly (4x per year) or monthly (12x per year) basis for treatment

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
7
Use of Metalworking Fluids
Used in Water-Based Metalworking Fluids only
50/50 split between water-based metalworking fluids and oil-based metalworking fluids

Throughput of MCCPs (kg/site-yr) based on high-end default of 12,000 gallons of Metalworking Fluid concentrate per site-yr
Throughput of MCCPs (kg/site-yr) based on mid-range default of 4,260  gallons of Metalworking Fluid purchased per site-yr

All release sources released to POTW or uncertain (POTW, Incineration or Landfill)
Oil-Based fluids  -  per OECD Emission Scenario Document (ESD), only dragout releases potentially 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
8
Formulation of Engine Lubricant
Shipping Container residue discharged to POTW after cleaning
Shipping Container residue collected then picked up on quarterly (4x per year) or monthly (12x per year) basis for treatment

All release sources released to POTW or uncertain (POTW, Incineration or Landfill)
Equipment cleaning release to incineration or landfill.
9
Use of Engine Lubricant
No release to POTW.
No additional release assessment scenarios were done
10
Formulation of Paints, Adhesives and Sealants
Shipping Container residue discharged to POTW after cleaning
Shipping Container residue collected then picked up on quarterly or monthly basis for treatment

Most conservative EPA model used for equipment cleaning release (Multiple Vessel cleanup)
Less conservative EPA model used for equipment cleaning release (Single Vessel cleanup)

Water releases from equipment cleaning discharged to POTW with no on-site pretreatment
Assumed on-site pretreatment at 70% efficiency prior to POTW
11

Application of Paints, 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
12
Textile Finishing
Water release sources discharged to POTW with no on-site pretreatment
Assumed on-site pretreatment at 70% efficiency prior to POTW

Summary of Release Assessment
The engineering report with details on estimates, calculations and assumptions is provided in Appendix E. Tables 9 through 11 presents a summary of the environmental release assessment with respect to the potential for release to a POTW for P-12-0282, 0283, and 0284, respectively.

Table 9: Summary of environmental release assessment and potential for release to a POTW for P-12-0282.
                                       #
                                   Scenario
                         MCCP Throughput (kg/site-yr)
                       MCCP Release to POTW (kg/site-yr)
                     % of MCCP Throughput released to POTW
1
Manufacture  -  Original (2012)
                                   5,874,955
                                       0
                                      0%
2
                             Plastics Compounding

Original (2012)
                                    157,889
                                     6,961
                                     4.41%

Equipment Cleaning to Incineration or Landfill (2016)
                                    157,889
                                     1,380
                                     0.87%
3
                              Plastics Converting

Original (2012)
                                    157,889
                                     8,958
                                     5.67%

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

                                    157,889
                                      214
                                     0.14%
4
                              Rubber Compounding

Original (2012)
                                    85,454
                                     2,455
                                     2.87%

Equipment Cleaning to Incineration (2016)
                                    85,454
                                      649
                                     0.76%
5
                              Rubber Converting

Original (2012)
                                    85,454
                                     4,896
                                     5.73%

Cutting/Trimming Only (2016)
                                    85,454
                                       0
                                      0%
6
                      Formulation of Metalworking Fluids

Original (2012)
                                    32,045
                                      914
                                     2.85%

Oil-Based (2016)
                                    32,045
                                      268
                                     0.84%

Water-Based, 50% on-site pretreatment (2016)
                                    32,045
                                      296
                                     0.92%

Water-Based, 70% on-site pretreatment (2016)
                                    32,045
                                      178
                                     0.55%

Water-Based, 99% on-site pretreatment (2016)
                                    32,045
                                       6
                                     0.02%
7
                          Use of Metalworking Fluids

Original (2012)
                                     4,542
                                     4,235
                                     93.2%

Oil-Based (2016)
                                     1612
                                      170
                                     10.5%

Water-based 50% on-site pretreatment (2016)
                                     1612
                                      802
                                      50%

Water-based 70% on-site pretreatment (2016)
                                     1612
                                      481
                                      30%

Water-Based 99% pretreatment (2016)
                                     1612
                                      16
                                      1%
8
                        Formulation of Engine Lubricant

Original (2012)
                                    15,667
                                      539
                                     3.44%

Equipment Cleaning to Incineration or Landfill (2016)
                                    15,667
                                      40
                                     0.25%
9
Use of Engine Lubricant  -  Original (2012)
                                     3,917
                                       0
                                      0%
10
Formulation of Paints, Adhesives and Sealants  -  Original (2012)
                                     1,780
                                      52
                                     2.94%

Formulation of Paints, Adhesives and Sealants  -  Expanded (2016)  -  Less conservative release model; 70% pretreatment
                                     1780
                                      11
                                     0.6%
11
Application of Paints, Adhesives and Sealants  -  Original (2012)
                                      502
                                      13
                                     2.60%
12
Textile Finishing  -  Original (2012)
                                     5,341
                                     1,107
                                     20.7%

Textile Finishing  -  Expanded (2016) - 70% pretreatment
                                     5341
                                      337
                                     6.3%

Table 10: Summary of environmental release assessment and potential for release to a POTW for P-12-0283.
                                       #
                                   Scenario
                         MCCP Throughput (kg/site-yr)
                       MCCP Release to POTW (kg/site-yr)
                     % of MCCP Throughput released to POTW
1
Manufacture  -  Original (2012)
                                   1,889,641
                                       0
                                      0%
2
                             Plastics Compounding

Original (2012)
                                    50,784
                                     1,453
                                     2.86%

Equipment Cleaning to Incineration or Landfill (2016)
                                    50,784
                                      450
                                     0.89%
3
                              Plastics Converting

Original (2012)
                                    50,784
                                     2,843
                                     5.60%

Solid Wastes from Equipment Cleaning, Container Cleaning, and Scrap Material to Incineration or Landfill; Dust Release to POTW or Landfill (2016)
                                    50,784
                                      73
                                     0.14%
4
                              Rubber Compounding

Original (2012)
                                    27,486
                                      790
                                     2.87%

Equipment Cleaning to Incineration (2016)
                                    27,486
                                      235
                                     0.86%
5
                              Rubber Converting

Original (2012)
                                    27,486
                                     1,570
                                     5.71%

Cutting/Trimming Only (2016)
                                    27,486
                                       0
                                      0%
6
                      Formulation of Metalworking Fluids

Original (2012)
                                    10,307
                                      289
                                     2.80%

Oil-Based (2016)
                                    10,307
                                      88
                                     0.85%

Water-Based, 50% on-site pretreatment (2016)
                                    10,307
                                      95
                                     0.92%

Water-Based, 70% on-site pretreatment (2016)
                                    10,307
                                      57
                                     0.55%

Water-Based, 99% on-site pretreatment (2016)
                                    10,307
                                       2
                                     0.02%
7
                          Use of Metalworking Fluids

Original (2012)
                                     4,535
                                     4,235
                                     93.4%

Oil-Based (2016)
                                     1,610
                                      170
                                     10.7%

Water-based 50% on-site pretreatment (2016)
                                     1,610
                                      800
                                      50%

Water-based 70% on-site pretreatment (2016)
                                     1,610
                                      486
                                      30%

Water-Based 99% pretreatment (2016)
                                     1,610
                                      16
                                      1%
8
                        Formulation of Engine Lubricant

Original (2012)
                                     5,039
                                      190
                                     3.76%

Equipment Cleaning to Incineration or Landfill (2016)
                                     5,039
                                      14
                                     0.27%
9
Use of Engine Lubricant  -  Original (2012)
                                     3,779
                                       0
                                      0%
10
Formulation of Paints, Adhesives and Sealants  -  Original (2012)
                                      573
                                      21
                                     3.61%

Formulation of Paints, Adhesives and Sealants  -  Expanded (2016)  -  Less conservative release model; 70% pretreatment
                                      573
                                      4.8
                                     0.83%
11
Application of Paints, Adhesives and Sealants  -  Original (2012)
                                      497
                                      13
                                     2.60%
12
Textile Finishing  -  Original (2012)
                                     1,718
                                      359
                                     20.9%

Textile Finishing  -  Expanded (2016) - 70% pretreatment
                                     1,718
                                      105
                                     6.1%

Table 11: Summary of environmental release assessment and potential for release to a POTW for P-12-0284.
                                       #
                                   Scenario
                         MCCP Throughput (kg/site-yr)
                       MCCP Release to POTW (kg/site-yr)
                     % of MCCP Throughput released to POTW
1
Manufacture  -  Original (2012)
                                    45,500
                                       0
                                      0%
2
                      Formulation of Metalworking Fluids

Original (2012)
                                     1,896
                                      56
                                     2.9%

Oil-Based (2016)
                                     1,896
                                      16
                                     0.85%

Water-Based, 50% on-site pretreatment (2016)
                                     1,896
                                      17
                                     0.91%

Water-Based, 70% on-site pretreatment (2016)
                                     1,896
                                      11
                                     0.56%

Water-Based, 99% on-site pretreatment (2016)
                                     1,896
                                     0.35
                                     0.02%
3
                          Use of Metalworking Fluids

Original (2012)
                                     4,550
                                     4,236
                                     93.1%

Oil-Based (2016)
                                     1,625
                                      173
                                     10.6%

Water-based 50% on-site pretreatment (2016)
                                     1,625
                                      802
                                     49.4%

Water-based 70% on-site pretreatment (2016)
                                     1,625
                                      484
                                     29.8%

Water-Based 99% pretreatment (2016)
                                     1,625
                                      16
                                      1%

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 a 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 5) 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-12-0282, 283, and 284.

The results of the E-FAST V2.0 modeling are provided in Appendix F. Tables 12 (MCCPs) and 13 (LCCP) present the values used in the risk assessment. As explained in the footnotes to these Tables, the values represent reasonable worst-case scenarios based on the processing and use scenarios presented in Tables 9, 10 and 11. 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, the E-FAST V2.0 models do not account for this partitioning.

The number of days of exceedance in the table below were generated by using a 1 ug/L CoC in the PDM model.

Table 12: E-FAST Modeling Values Used for MCCPs[1]

                                  Scenario[2]
                          Water Release  -  Human[3]
                           Air Release  -  Human[3]
                    Water Release  -  Aquatic Organisms[4]

                                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 exceedance
                                   P-12-0282
Manufacturing
                                  No releases
                                  No releases
                                2.76 x 10[-3]
                                  No releases
                                  No releases
                                  No releases
Proc1 (Plastic Compounding)
                                9.44 x 10[-2]
                                 8.33 x 10[0]
2.34 x 10[-3]
                                1.91 x 10[-2]
                                0.07-0.49 (2.5)
                                      115
Use1 (Plastic Converting)
                                2.36 x 10[-4]
                                1.91 x 10[-2]
                                2.40 x 10[-4]
                                1.10 x 10[-1]
                                0.06-1.9 (10.7)
                                      176
Proc2 (Rubber Compounding)
                                4.56 x 10[-2]
                                4.02 x 10[-0]
                                1.20 x 10[-3]
                                1.22 x 10[-3]
                               0.03-0.25 (1.26)
                                      19
Use2 (Rubber converting)
                                  No releases
                                  No releases
                                5.72 x 10[-5]
                                  No releases
                                  No releases
                                  No releases
Proc3 (Formulation of metal working fluids (MWF)):
Oil based MWF
                                1.91 x 10[-2]
                                 1.69 x 10[0]
                                6.20 x 10[-4]
                                5.74 x 10[-3]
                             23.2  -  169.2 (863)*
                                      NA
Proc3
Water based MWF 50%
1.09 x 10[-2]
                                9.70 x 10[-1]
                                3.30 x 10[-4]
                                5.74 x 10[-3]
                                1.5-10.6 (54.1)
                                      38
Proc3
Water based MWF 70%
                                6.61 x 10[-3]
                                5.80 x 10[-1]
                                2.70 x 10[-4]
                                5.74 x 10[-3]
                              0.9  -  6.3 (32.2)
                                      37
Proc3
Water based MWF 99%
                                2.15 x 10[-4]
                                1.90 x 10[-2]
                                1.20 x 10[-4]
                                5.74 x 10[-3]
                                0.03-0.2 (1.1)
                                       6
Use3 Use of metal working fluids (MWF)
 Oil based MWF
                                5.65 x 10[-4]
                                2.94 x 10[-2]
                                4.73 x 10[-5]
                                  No releases
                              0.2  -  2.9 (26.5)
                                      174
Use3
Water based MWF 50%
                                2.79 x 10[-3]
                                1.50 x 10[-1]
                                2.09 x 10[-5]
                                  No releases
                              1.05  -  13.3 (119)
                                      235
Use3
Water based MWF 70%
                                1.68 x 10[-3]
                                8.73 x 10[-2]
                                1.26 x 10[-5]
                                  No releases
                             0.63  -  7.96 (71.6)
                                      222
Use3
Water based MWF 99%
5.67 x 10[-5]
                                2.95 x 10[-3]
                                4.30 x 10[-7]
                                  No releases
                              0.02  -  0.3 (2.4)
                                      39
Proc4 Formulation of engine lubricants
2.82 x 10[-3]
                                2.50 x 10[-1]
                                9.77 x 10[-5]
                                  No releases
                              3.4  -  25.0 (128)*
                                      NA
Use4
Use of engine lubricants
No releases
                                  No releases
                                8.82 x 10[-5]
                                  No releases
                                  No releases
                                  No releases
Proc5 Formulation of paints, etc.
1.20 x 10[-3]
                                1.10 x 10[-1]
                                2.48 x 10[-3]
                                  No releases
                                1.5-10.6 (54)*
                                      NA
Use5 Application of paints, etc
1.11 x 10[-4]
                                5.11 x 10[-3]
                                3.80 x 10[-7]
                                2.05 x 10[-2]
                                0.03-0.36 (3.8)
                                      68
Use6 Textile finishing
1.20 x 10[-3]
                                1.10 x 10[-1]
                                2.09 x 10[-5]
                                  No releases
                              0.38  -  2.8 (14.2)
                                      254
   P-12-0283 ("Proc" and "Use" parameters are the same as P-12-0282)
Manufacturing
No releases
No releases
2.76 x 10[-3]
No releases
No releases
No releases
Proc1 (Plastic Compounding)
3.09 x 10[-2]
3.05 x 10[-2]
8.40 x 10[-4]
2.87 x 10[-2]
0.1-0.74 (3.8)
                                      32
Use1 (Plastic Converting)
8.01 x 10[-5]
7.27 x 10[-5]
7.56 x 10[-5]
3.42 x 10[-2]
0.02-0.65 (3.6)
                                      104
Proc2 (Rubber Compounding)
1.66 x 10[-2]
1.64 x 10[-2]
5.10 x 10[-4]
1.22 x 10[-3]
0.034-0.25 (1.26)
                                       6
Use2 (Rubber converting)
No releases
No releases
1.82 x 10[-5]
No releases
No releases
                                  No releases
Proc3 (Formulation of metal working fluids (MWF)):
Oil based MWF
6.27 x 10[-3]
6.20 x 10[-3]
3.20 x 10[-4]
5.88 x 10[-3]
7.6  -  55.6 (284)*
                                      NA
Proc3
Water based MWF 50%
4.33 x 10[-3]
4.28 x 10[-3]
2.00 x 10[-4]
5.88 x 10[-3]
5.3  -  38.4 (196)*
                                      NA
Proc3
Water based MWF 70%
2.59 x 10[-3]
2.56 x 10[-3]
1.80 x 10[-4]
5.88 x 10[-3]
3.2  -  23.0 (117)*
                                      NA
Proc3
Water based MWF 99%
8.72 x 10[-5]
8.62 x 10[-5]
1.20 x 10[-4]
5.88 x 10[-3]
0.11  -  0.77 (3.9)*
                                      NA
Use3 Use of metal working fluids (MWF)
 Oil based MWF
5.65 x 10[-4]
3.29 x 10[-4]
4.73 x 10[-5]
No releases
0.2  -  2.9 (26.5)
                                      174
Use3
Water based MWF 50%
2.79 x 10[-3]
1.63 x 10[-3]
2.09 x 10[-5]
No releases
1.05  -  13.3 (119.3)
                                      235
Use3
Water based MWF 70%
1.68 x 10[-3]
9.78 x 10[-4]
1.26 x 10[-5]
No releases
0.63  -  7.96 (71.6)
                                      222
Use3
Water based MWF 99%
5.67 x 10[-5]
3.30 x 10[-5]
4.30 x 10[-7]
No releases
0.02  -  0.3 (2.4)
                                      39
Proc4 Formulation of engine lubricants
8.83 x 10[-4]
8.74 x 10[-4]
4.92 x 10[-5]
No releases
1.1  -  7.8 (40)*
                                      NA
Use4
Use of engine lubricants
No releases
No releases
1.21 x 10[-5]
No releases
No releases
                                  No releases
Proc5 Formulation of paints, etc.
1.13 x 10[-3]
1.12 x 10[-3]
2.00 x 10[-3]
No releases
 1.37-10.00 (51)*
                                      NA
Use5 Application of paints, etc
1.11 x 10[-4]
5.73 x 10[-5]
3.80 x 10[-7]
2.05 x 10[-2]
0.03-0.36 (3.8)
                                      67
Use6 Textile finishing
1.20 x 10[-3]
1.18 x 10[-3]
2.09 x 10[-5]
No releases
0.38  -  2.8 (14.2)
	82
1 Taken from Appendix F. Values represent the highest concentrations/estimated (lifetime average daily dose, or LADD) doses for chronic (i.e., repeated exposure scenarios) for human health.
[2] Proc1-5 = Processing, or formulating for listed products. MWF = metalworking fluids (MWFs). Use 1-6 = corresponding commercial use of products.
[3] Estimated exposure values were corrected for absorption by the oral (50 % absorption) and inhalation (50 % absorption) routes of exposure (ECB 2005; EA 2009).
[4] 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., 0.07 ug/L) up to the central tendency for a low flow site (e.g., 0.49 ug/L)  -  this example was taken from the second row (Proc1, Plastics Compounding) under P-12-0282 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., 2.5 ug/L) value normally used to determine 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.

Table 13: E-FAST Modeling Values Used for the LCCP (P-12-0284) [1]

                                  Scenario[2]
                          Water Release  -  Human[3]
                           Air Release  -  Human[3]

                    Water Release  -  Aquatic Organisms[4]

                              Drinking Water ADR
                                (mg/kg-bw/day)
                              Fish Ingestion ADR
                                (mg/kg-bw/day)
                            Stack Air ADR (mg/m[3])
                          Fugitive Air ADR (mg/m[3])
                        Range of Concentrations (ug/L)
                              Days of exceedance
Manufacturing
                                  No releases
                                  No releases
                                2.76 x 10[-3]
                                  No releases
                                  No releases
                                      NA
                       Formulation of Metalworking Fluid
Oil based MWF
                                1.06 x 10[-3]
                                9.36 x 10[-2]
                                6.34 x 10[-5]
                                1.28 x 10[-3]
                              1.3  -  9.4 (47.9)*
                                      NA
Water based MWF 50%
                                7.84 x 10[-4]
                                6.92 x 10[-2]
                                4.41 x 10[-5]
                                1.28 x 10[-3]
                             0.95  -  6.9 (35.4)*
                                      NA
Water based MWF 70%
                                4.79 x 10[-4]
                                4.23 x 10[-2]
                                3.69 x 10[-5]
                                1.28 x 10[-3]
                             0.58  -  4.2 (21.6)*
                                      NA
Water based MWF 99%
                                1.60 x 10[-5]
                                1.41 x 10[-3]
                                2.60 x 10[-5]
                                1.28 x 10[-3]
                            0.019  -  0.14 (0.72)*
                                      NA
                           Use of Metalworking Fluid
Oil based MWF
                                5.65 x 10[-4]
                                2.94 x 10[-2]
                                4.73 x 10[-5]
                                  No releases
                             0.23  -  2.95 (26.5)
                                      174
Water based MWF 50%
                                2.79 x 10[-3]
                                1.50 x 10[-1]
                                2.09 x 10[-5]
                                  No releases
                              1.15  -  14.6 (119)
                                      235
Water based MWF 70%
                                1.69 x 10[-3]
                                8.77 x 10[-2]
                                1.27 x 10[-5]
                                  No releases
                             0.63  -  8.00 (72.0)
                                      222
Water based MWF 99%
                                5.67 x 10[-5]
                                2.95 x 10[-3]
                                4.30 x 10[-7]
                                  No releases
                             0.021  -  0.27 (2.4)
                                      39
[1]Taken from Appendix F. Values represent the highest concentrations/estimated (lifetime average daily dose, or LADD) doses for chronic (i.e., repeated exposure scenarios) for human health.
[2] MWF = metalworking fluids,
[3] Estimated exposure values were corrected for absorption by the oral (50 % absorption) and inhalation (50 % absorption) routes of exposure (ECB 2005; EA 2009).
[4] 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., 1.3 ug/L) up to the central tendency for a low flow site (e.g., 38.7 ug/L). The central tendency was calculated using the harmonic mean flow. The value in parentheses represents the 7Q10 (e.g., 215 ug/L) value normally used to determine potential chronic risk to aquatic organisms.
* 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.
NA indicates that the there are not a sufficient number of days of release to calculate the days of exceedance where a chronic CoC was exceeded.

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:
               Manufacture at Dover site in Dover, OH and Hammond Works site in Hammond, IN (Note: P-12-0284 was only manufactured at the Dover site)
               Plastics Compounding
               Converting of Compounded Plastics into Articles
               Rubber Compounding
               Converting of Compounded Rubber into Articles
               Formulation of Metalworking Fluids
               Use of Metalworking Fluids
               Formulation of Engine Lubricants
               Use of Engine Lubricants
               Formulation of Paints, Adhesives and Sealants
               Application of Paints, Adhesives and Sealants
               Textile Finishing

	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

Dermal exposure to used motor oil from "do it yourself" consumer activities were also assessed for the MCCPs (P-12-0282 and 0283). P-12-0284 did not have any consumer exposures.

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 Appendix 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)
 Percent of production volume for a given use (e.g., 30% 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 14 summarizes the sources utilized for each operation assessed; which encompasses both MCCPs/LCCPs.
Personal Protective Equipment - EPA does not account for protection from use of respiratory protection in its screening-level assessments of inhalation exposure.

Table 14: Data Sources for Inhalation Exposures.

                                   Operation
                   Source of Inhalation exposure assessment
1
Manufacture at Dover site in Dover, OH and Hammond Works site in Hammond, IN
Negligible per EPA assessment policy for non-volatile liquids
2
Plastics Compounding (Proc1)
Monitoring data for MCCP vapor exposure in published source
3
Converting of Compounded Plastics into Articles (Use1)
Monitoring data for MCCP vapor exposure in published source
4
Rubber Compounding (Proc2)
Monitoring data for MCCP vapor exposure in published source
5
Converting of Compounded Rubber into Articles (Use2)
Not expected as chemicals are entrained in solid sheet.
6
Formulation of Metalworking Fluids (Proc3)
Negligible per EPA assessment policy for non-volatile liquids
7
Use of Metalworking Fluids (Use3)
Monitoring data for oil mist exposure in OECD Emission Scenario Document on Use of Metalworking Fluids
8
Formulation of Engine Lubricants (Proc4)
Negligible per EPA assessment policy for non-volatile liquids
9
Use of Engine Lubricants (Use4)
Negligible per EPA assessment policy for non-volatile liquids
10
Formulation of Paints, Adhesives and Sealants (Proc5)
Negligible per EPA assessment policy for non-volatile liquids
11
Application of Paints, Adhesives and Sealants (Use5)
Monitoring data for MCCP vapor exposure in published source and standard EPA model for spray application of paints
12
Textile Finishing (Use6)
Negligible per EPA assessment policy for non-volatile liquids

Summary of Occupational Exposure Assessment
Tables 15 (MCCPs) and 17 (LCCP) below present a summary of the occupational exposure estimates for P-12-0282/0283 and 0284, respectively. No additional occupational exposure assessment work was performed for most of the scenarios in this 2016 assessment; the estimates presented below are the same as for the previous EPA risk assessment. The lone exception is that inhalation exposures during rubber converting are not expected based on industry information. Table 16 provides details on the number of sites, workers, and days working/year for each of the two MCCP PMNs.

Table 15: Summary of Occupational Exposure Estimates Used for the MCCPs (P-12-0282 and 0283)[1,2]
                                   Scenario
                             Route of Exposure[3]

                              Inhalation (mg/day)
                                Dermal (mg/day)
Manufacturing
Negligible due to low vapor pressure
1100 (sampling liquid)
2200 (loading liquid)
Proc1  -  Plastics Compounding
0.03-4.4
2200 (unloading liquid)
Proc2  -  Rubber Compounding
0.1-0.7
2200 (unloading liquid)
Proc3  -  Formulating MWF
Negligible due to low vapor pressure
220 (loading liquid)
2200 (unloading liquid)
Proc4  -  Formulating engine oil
Negligible due to low vapor pressure
90 (loading liquid)
2200 (unloading liquid)
Proc5  -  Formulating plasticizer in paints, sealants, adhesives
Negligible due to low vapor pressure
340 (loading liquid)
2200 (unloading liquid)
Use1  -  Plastics converting
12 - 15
Non-quantifiable[4]
Use2  -  Rubber converting
0.7 - 15
Non-quantifiable[5]
Use3  -  Commercial use of MWF
0.98  -  3.6 (mist)
220 (liquid)
490 (mist)
Use4  -  Commercial use of engine oil
Negligible due to low vapor pressure
90 (unloading liquid)
Use5  -  Commercial use of paints, sealants, adhesives
1.9  -  90 (mist)
340 (unloading liquid)
1300 (coating using hand-held spray gun)
Use6  -  Commercial use of textiles containing PMN as flame retardant/plasticizer
Negligible due to low vapor pressure
550 (during finishing)
2200 (unloading)
[1] All values apply to both P-12-0282 and P-12-00283, with exceptions noted below. If one value is listed, it represents a "high end" exposure estimates if there are two values they represent the range of low end to high end. Some of the inhalation exposure values represent actual monitoring data from Europe and are cited appropriately below, others are estimates. Most dermal values are estimates; for sampling scenarios the assumption is that one hand is used, for loading/unloading, it is assumed that two hands are used. Exceptions are noted below.
[2] See Table 14 for details on the number of sites, workers, and days/year for each scenario.
3 Proc1 = Inhalation values based on range of monitoring data from EU  -  0.003 to 0.44 mg/m[3] converted to mg/day by multiplying by 10 m[3]  -  the volume of air taken in by a worker over an eight-hour work shift (EU cited as 2008 EU risk assessment; see engineering report for P-12-0282 on pdf page 8).
Proc2 = Inhalation values based on range of monitoring data from EU  -  0.01 to 0.07 mg/m[3] converted to mg/day by multiplying by 10 m[3]  -  the volume of air taken in by a worker over an eight-hour work shift (EU cited as 2008 EU risk assessment; see engineering report for P-12-0282 on pdf page 12).
Use 1 = Inhalation values. The low end of the range is based on the high end of the range of monitoring data from EU  -  0.01 to 1.2 mg/m[3] converted to mg/day by multiplying by 10 m[3]  -  the volume of air taken in by a worker over an eight-hour work shift. The high end is based on the OSHA PEL for "paraffin oil mist", which is converted from 5 mg/m[3] to 1.5 mg/m[3] to account for 30% of product containing PMN substance (see: http://www.cdc.gov/niosh/npg/npgd0472.html ).
Use 2 = A 2008 EU RA on MCCPs and a 2010 EU CSR on MCCPs contains monitoring data from rubber manufacturing operations in the EU.  The monitoring data suggest MCCP air concentrations ranging from 0.01 to 0.07 mg/m3 based on monitoring conducted at 1 site.  It is unknown whether these data represent area or personal monitoring data.  Exposure is based on the high-end of the EU data range (0.07 mg/m3) and the OSHA PEL for Particulates Not Otherwise Regulated (15 mg/m3 x 10% MCCP) = 1.5 mg/m3.
Use 3 = Inhalation exposures. User-defined Inhalation Model. The 2011 ESD for MWF Operations estimates typical mist concentrations ranging from 0.19 to 0.39 mg/m[3] and high end concentrations ranging from 0.87 to 1.42 mg/m[3] depending on the type of MWF used. These estimates are based on the geometric mean (typical) and 90th percentile data (high end) of data collected by NIOSH from 942 machinists at 79 shops across the U.S. A range of inhalation exposure estimates are based the high end for the range of geometric means and 90[th] percentiles. It is assumed that the PMN is 25% of the mist (generic scenario assumptions: water conc. is 60% and the PMN is then estimated to be 10/40 = 25% of the mist). Dermal exposures. User-defined Dermal Model. The 2011 ESD for MWF Operations estimates an average dermal surface loading rate for MWFs of 2.9 mg/cm[2]-hr during metalworking operations. These data are more conservative than the EPA/OPPT 2-Hand Dermal Contact Model and are used to provide a conservative estimate of dermal exposure during MWF use due to uncertainty at downstream operations (see engineering report for P-12-0282 at pdf pages 20-21).
Use 5 = Inhalation exposures. Coating using hand-held spray gun; EPA/OPPT Automobile Refinish Spray coating Inhalation Model (non-volatile non-polyisocyanates). A 2002 EU RA on MCCPs and a 2010 EU CSR on MCCPs presents air monitoring data from paint spray application with values ranging from 0.002 to 0.19 mg/m[3] with a median of 0.04 mg/m[3] and a 90[th] percentile of 0.085 mg/m[3]. The EPA/OPPT Autorefinishing Spray Coating Model calculates an exposure of 9 mg/m[3]. The EPA/OPPT model is used to provide a conservative estimate due to uncertainty in downstream use sites. Taking the highest measured value (0.19) and the model value (9) and converted them to mg/day by multiplying by 10 m[3]  -  the volume of air taken in by a worker over an eight-hour work shift; results in the range of 1.9  -  90 mg/day. (SEE TEXT IN SECITON 6.2.1 FOR FURTHER EVALUATION OF THE EU MONITORING DATA).
[4]PMN will be encapsulated in rubber sheets/blocks during handling of rubber raw material. While some surface contact may occur, dermal exposure to solids in this form is non-quantifiable.

Table 16: Occupational Exposure Details for the MCCPs (P-12-0282 and 0283)[1]
                                   Scenario
                                Number of Sites
                               Number of Workers
                              Number of Days/year
Manufacturing
                                       2
                                       8
                                    250, 93
Proc1  -  Plastics Compounding
                                      32
                                      768
                                    250, 60
Proc2  -  Rubber Compounding
                                      33
                                      792
                                    96, 31
Proc3  -  Formulating MWF
                                      110
                                      440
                                    38, 12
Proc4  -  Formulating engine oil
                                      15
                                      225
                                    34, 12
Proc5  -  Formulating plasticizer in paints, sealants, adhesives
                                      33
                                     1287
                                     5, 2
Use1  -  Plastics converting
                                      32
                                     1536
                                      250
Use2  -  Rubber converting
                                      33
                                     1584
                                      250
Use3  -  Commercial use of MWF
                                   776, 250
                                37,248; 12,000
                                      247
Use4  -  Commercial use of engine oil
                                    48, 16
                                    240, 80
                                      250
Use5  -  Commercial use of paints, sealants, adhesives
                                    117, 38
                                   351, 114
                                   250, 249
Use6  -  Commercial use of textiles containing PMN as flame retardant/plasticizer
                                      11
                                      33
                                    250, 95
[1] If a single value is present, it is the same for both P-12-0282 and P-12-0283. If there are two values, the first one is P-12-0282 and the second is P-12-0283

Table 17: Summary of Occupational Exposure Estimates Used for the LCCPs (P-12-0284)[1]
                               Route of Exposure
                                 Manufacturing
                                  Processing
                                    Use[3]
                                  Inhalation
                                   (mg/day)
                     Negligible due to low vapor pressure
                     Negligible due to low vapor pressure
                              0.98  -  3.6 (mist)
                                   Dermal[2]
                                   (mg/day)
                                1100 (sampling)
                                2200 (loading)
                                 220 (loading)
                               2200 (unloading)
                             220(unloading liquid)
                                  490 (mist)
[1]The following represent the estimated number of sites and workers per scenario:
Manufacturing (one site, four workers  -  three days/year)
Processing = formulation of metalworking fluids, MWFs (24 sites, 192 workers  -  ten days/year)
Use = use of MWFs (10 sites, 480 workers, 247 days/year)
2 Most dermal values are estimates; for sampling scenarios the assumption is that one hand is used, for loading/unloading, it is assumed that two hands are used. Exceptions are noted below.
3 Inhalation exposures. User-defined Inhalation Model. The 2011 ESD for MWF Operations estimates typical mist concentrations ranging from 0.19 to 0.39 mg/m[3] and high end concentrations ranging from 0.87 to 1.42 mg/m[3] depending on the type of MWF used. These estimates are based on the geometric mean (typical) and 90[th] percentile data (high end) of data collected by NIOSH from 942 machinists at 79 shops across the U.S. A range of inhalation exposure estimates are based the high end for the range of geometric means and 90[th] percentiles. It is assumed that the PMN is 25% of the mist (generic scenario assumptions: water conc. is 60% and the PMN is then estimated to be 10/40 = 25% of the mist). Dermal exposures. User-defined Dermal Model. The 2011 ESD for MWF Operations estimates an average dermal surface loading rate for MWFs of 2.9 mg/cm[2]-hr during metalworking operations. These data are more conservative than the EPA/OPPT 2-Hand Dermal Contact Model and are used to provide a conservative estimate of dermal exposure during MWF use due to uncertainty at downstream operations (see engineering report for P-12-0284 at pdf pages 8-9).

CONSUMER EXPOSURE
For the two MCCP PMNs, estimates were made for "do it yourself" consumers being exposed to P-12-0282 and P-12-0283 via a used motor oil exposure scenario. Table 18 provides the estimates and the assumptions used. Dover did not identify consumer uses for in its PMN application for P-12-0284; therefore, the Agency did not perform an assessment for these types of exposures for the LCCP.

Table 18: Consumer Exposure Results Summary for Dermal Exposure to Used Motor Oil[1]
                         Scenario: CEM Used Motor Oil
                                    Dermal
                                  Inhalation

           Acute Dose Rate (Highest Daily Exposure) in mg/kg-bw/day
P-12-0282 and P-12-0283
                                     24.6
                        No inhalation exposure expected
1 Assumptions include: used oil is handled four times/year, amount retained is 0.0105 grams/cm[2] per handling event.

RISK ASSESSMENT

ENVIRONMENTAL ASSESSMENT
EPA 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-12-0282 to 0284, 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-12-0282 to 0284. 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 6 and 7) or estimated (see Tables 9, 10 and 11) 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 5).

An RQ greater than one serves as a benchmark for identifying whether aquatic concentrations of P-12-0282 to 0284 may present an unreasonable risk to aquatic- and sediment-dwelling organisms.

Risk Estimates Using Environmental Monitoring Data
The RQs shown in Table 19 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-12-0282 to 0284.

Table 19: Risk Quotients Calculated from Monitoring Data for Surface Water, Sediment and the Terrestrial Environment

                          Environmental Concentration
                                 Effect Level
                                  (i.e., COC)
                                    RQs[1]
Acute Risk
Aquatic Species
                    < 2.50x10[-10] to 1.49x10[-3] mg/L
                                  0.001 mg/L
                           < 2.50x10[-7] to 1.49
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