Insufficient Data
                               14.9 mg/kg dw[2]
                                Not calculated
[1]Bolded values represent those that may present a risk of injury.
[2]The COCs for terrestrial invertebrates and vertebrates were 14.9 mg/kg dw and 16.8 mg/kg diet, respectively. Since these values were comparable, EPA/OPPT used the lowest value for calculating RQs for this compartment.

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

For sediment concentrations, EPA/OPPT reviewed multiple studies, some of which reported values that exceeded the COC. Nicholls et al. (2001) reported the most relevant data for P-12-0282-0284. These authors measured concentrations of MCCPs at locations in the United Kingdom where specific industries were known to employ MCCPs in the use categories identified for the PMN substances (e.g., lubricant in MWFs, plasticizer in PVC resins, and lubricant in sealants). Eight locations were sampled at three distances downstream (i.e., 100 meters, 300 meters, and 1-2 kilometers) from the respective sewage treatment works. At four of the locations, at least one of the sampled downstream values exceeded the COC (i.e., RQs > 1, risk finding). Though it is not possible to parse out the contribution of specific uses to the measured values, these data support that releases occur at locations with relevant uses to the PMN substances, which contribute to the environmental load of MCCP congener groups and in some cases result in RQs greater than one.

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

Due to the foregoing limitations and resulting uncertainties with the measured environmental data, EPA/OPPT used these data in a limited capacity for estimating potential risks associated with the use categories identified for P-12-0282 to 0284. Specifically, these data were used as supporting information to inform the relevant pathways for estimating potential releases from relevant use categories for the PMN substances. A summary of the estimated release values and associated RQs that EPA/OPPT used as the primary basis for evaluating the potential risks of P-12-0282 to 0284 is presented in the following section.

Risk Estimates Using Modeled Exposures
The RQs shown in Tables 20, 21 and 22 suggest that, using the conventional EPA PMN method of using the 7Q10 flow scenario to represent the modeled concentration in water, all of the intended processes and uses for P-12-0282 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 of injury to aquatic organisms.

Importantly, the Federal Register notice in 2015 requesting additional information regarding the use/removal/environmental release of CPs from the uses evaluated in this assessment resulted in significant changes for some water release/risk assessment calculations. Use of the submitted industry information pertaining to pre-treatment of MWFs (water -based vs. oil-based assumptions) resulted in declines in the 7Q10 estimate and the resulting estimate for risk. This was particularly evident when the median stream flow scenario is included in the range of risk estimates. For example, for P-12-0282, use of MWFs (Use3), the original EPA 2012 assessment predicted a median flow value of 0.2 ug/L and a 7Q10 flow of 26.5 ug/L; resulting in RQs of 0.2  -  26.5. When the water-based scenario is used (99% removal on-site, prior to release to POTW), the resulting range in RQs is 0.02  -  2.4.

When the water-based assumptions are used, there are several scenarios which suggest either no risk (RQ<1) or very slight risk (RQ<2):

 P-12-0282: Formulation of MWF (water-base, 99%)  -  RQ range of 0.031- 1.1;
 P-12-0283: Formulation of MWF (water-base, 99%)  -  RQ range of 0.11- 1.1; and
 the single scenario for which there was an estimate of no risk - P-12-0284: Formulation of MWF (water-base, 99%)  -  RQ range of 0.019  -  0.72;

Also, there was one scenario (Rubber Compounding, Proc2) for both P-0282 and 0283 in which an RQ range of 0.03-1.26 was estimated.

It is noteworthy that the estimated concentrations in Tables 20-22 are within the range of measured surface water concentrations reported for MCCP and LCCP congener groups (Tables 6 and 7). Though there is uncertainty whether the form (i.e., dissolved or particle bound) of CP impacts the aquatic toxicity, the estimated values suggest that either form may exist. The median stream flow estimates are all below the reported water solubility for the MCCPs (P-12-0282 and 0283) and slightly above or below the water solubility reported for the LCCP (P-12-0284) (Table 2). Since the available aquatic toxicity data support that dissolved MCCP congener groups cause toxicity, the estimated water concentration values suggest that the risk finding for these scenarios are plausible. Some low stream flow and most 7Q10 flow scenarios estimate water concentrations that far exceed the estimated water solubility of all three PMN substances. Under these scenarios, the MCCP or LCCP congener groups would likely be bound to particulates and would eventually settle out in sediment. Nicholls et al. (2001) provided support for this pathway and showed that sediment concentrations of MCCP congener groups generally increased with distance downstream from the source outfall. Based on the foregoing information, EPA/OPPT concludes the following: 1) the estimated water concentrations were adequate for determining that environmental releases of P-12-0282 to 0284 may present a risk of injury to aquatic organisms; and 2) it was unnecessary to estimate sediment concentrations of CP congener groups because any potential risks to sediment-dwelling organisms would be managed by addressing the risks identified for aquatic organisms.

Table 20: Risk Assessment of Aquatic Organisms using Modeled Exposures to P-12-0282[1]
                                   Scenario
                   Estimated Water Concentrations (ug/L)[2]

                                   RQs[3,4]

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

Manufacturing
                                  No releases
                                  No releases
                                  No releases
                                  No releases
                                       0
Plastics Compounding (Proc1)
                                     0.07
                                     0.49
                                      2.5
                                      115
                                   0.07-2.5
Plastic Converting (Use1)
                                     0.06
                                      1.9
                                     10.7
                                      176
                                 0.06  -  10.7
Rubber Compounding (Proc2)
                                     0.03
                                     0.25
                                     1.26
                                      19
                                   0.03-1.26
Rubber converting (Use2)
                                  No releases
                                  No releases
                                  No releases
                                  No releases
                                       0
Formulation of metal working fluids (MWF)  -  Proc3
Oil based MWF
                                     23.2
                                     169.2
                                      863
                                      NA
                                   23.2-863
Water based MWF 50%
                                      1.5
                                     10.6
                                     54.1
                                      38
                                   1.5-54.1
Water based MWF 70%
                                      0.9
                                      6.3
                                     32.2
                                      37
                                   0.9-32.2
Water based MWF 99%
                                     0.03
                                      0.2
                                      1.1
                                       6
                                   0.03-1.1
Use of metal working fluids (MWF)  -  Use3
Oil based MWF
                                      0.2
                                      2.9
                                     26.5
                                      174
                                   0.2-26.5
Water based MWF 50%
                                     1.05
                                     13.3
                                      119
                                      235
                                   1.05-119
Water based MWF 70%
                                     0.63
                                     7.96
                                     71.6
                                      222
                                   0.63-71.6
Water based MWF 99%
                                     0.02
                                      0.3
                                      2.4
                                      39
                                   0.02-2.4
Formulation of engine
Lubricants (Proc4)
                                      3.4
                                     25.0
                                      128
                                      NA
                                    3.4-128
Use of engine lubricants (Use4)
                                  No releases
                                  No releases
                                  No releases
                                  No releases
                                       0
Formulation of paints, etc. (Proc5)
                                      1.5
                                     10.6
                                      54
                                      NA
                                    1.5-54
Application of paints, etc (Use5)
                                     0.03
                                     0.36
                                      3.8
                                      68
                                   0.03-3.8
Textile finishing (Use6)
                                     0.38
                                      2.8
                                     14.2
                                      254
                                   0.38-14.2
[1] Taken from full model run of summary data presented in Appendix E.
2 For PMNs, EPA/OPPT evaluated potential environmental risks by performing a PDM as described above and in the "Exposure and Fate Assessment Screening Tool (E-FAST) Version 2.0 Documentation Manual (2007)", available at: http://www.epa.gov/opptintr/exposure/pubs/efast2man.pdf
[3] Bolded values represent those that may present an unreasonable risk of injury.
[4]The hazard value used is 1 ug/L.

Table 21: Risk Assessment of Aquatic Organisms using Modeled Exposures to P-12-0283[1]
                                   Scenario
                   Estimated Water Concentrations (ug/L)[2]

                                   RQs[3,4]

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

Manufacturing
                                  No releases
                                  No releases
                                  No releases
                                  No releases
                                       0
Plastics Compounding (Proc1)
                                      0.1
                                     0.74
                                      3.8
                                      32
                                    0.1-3.8
Plastic Converting (Use1)
                                     0.02
                                     0.65
                                      3.6
                                      104
                                 0.02  -  3.6
Rubber Compounding (Proc2)
                                     0.034
                                     0.25
                                     1.26
                                       6
                                   0.03-1.26
Rubber converting (Use2)
                                  No releases
                                  No releases
                                  No releases
                                  No releases
                                       0
 Formulation of metal working fluids (MWF)  -  Proc3
Oil based MWF
                                      7.6
                                     55.6
                                      284
                                      NA
                                    7.6-284
Water based MWF 50%
                                      5.3
                                     38.4
                                      196
                                      NA
                                    5.3-196
Water based MWF 70%
                                      3.2
                                     23.0
                                      117
                                      NA
                                    3.2-117
Water based MWF 99%
                                     0.11
                                     0.77
                                      1.1
                                      NA
                                   0.11-1.1
Use of metal working fluids (MWF)  -  Use3
Oil based MWF
                                      0.2
                                      2.9
                                     26.5
                                      174
                                   0.2-26.5
Water based MWF 50%
                                     1.05
                                     13.3
                                      119
                                      235
                                   1.05-119
Water based MWF 70%
                                     0.63
                                     7.96
                                     71.6
                                      222
                                   0.63-71.6
Water based MWF 99%
                                     0.02
                                      0.3
                                      2.4
                                      39
                                   0.02-2.4
Formulation of engine
Lubricants (Proc4)
                                      1.1
                                      7.8
                                      40
                                      NA
                                    1.1-40
Use of engine lubricants (Use4)
                                  No releases
                                  No releases
                                  No releases
                                  No releases
                                       0
Formulation of paints, etc. (Proc5)
                                     1.37
                                     10.0
                                      51
                                      NA
                                    1.37-51
Application of paints, etc (Use5)
                                     0.03
                                     0.36
                                      3.8
                                      67
                                   0.03-3.8
Textile finishing (Use6)
                                     0.38
                                      2.8
                                     14.2
                                      82
                                   0.38-14.2
[1] Taken from full model run of summary data presented in Appendix E.
[2] For PMNs, EPA/OPPT evaluated potential environmental risks by performing a PDM as described above and in the "Exposure and Fate Assessment Screening Tool (E-FAST) Version 2.0 Documentation Manual (2007)", available at: http://www.epa.gov/opptintr/exposure/pubs/efast2man.pdf
[3] Bolded values represent those that may present an unreasonable risk of injury.
[4]The hazard value used is 1 ug/L.

Table 22: Risk Assessment of Aquatic Organisms using Modeled Exposures to P-12-0284[1]
                                   Scenario
                   Estimated Water Concentrations (ug/L)[2]

                                      RQs

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

Manufacturing
                                  No releases
                                  No releases
                                  No releases
                                  No releases
                                       0
Formulation of metal working fluids (MWF)
Oil based MWF
                                      1.3
                                      9.4
                                     47.9
                                      NA
                                   1.3-47.9
Water based MWF 50%
                                     0.95
                                      6.9
                                     35.4
                                      NA
                                   0.95-35.4
Water based MWF 70%
                                     0.58
                                      4.2
                                     21.6
                                      NA
                                   0.58-21.6
Water based MWF 99%
                                     0.019
                                     0.14
                                     0.72
                                      NA
                                  0.019-0.72
Use of metal working fluids (MWF)
Oil based MWF
                                     0.23
                                     2.95
                                     26.5
                                      174
                                   0.23-26.5
Water based MWF 50%
                                     1.15
                                     14.6
                                      119
                                      235
                                   1.15-119
Water based MWF 70%
                                     0.63
                                     8.00
                                     72.0
                                      222
                                    0.63-72
Water based MWF 99%
                                     0.021
                                     0.27
                                      2.4
                                      39
                                   0.021-2.4
[1] Taken from full model run of summary data presented in Appendix E.
[2]For PMNs, EPA/OPPT evaluated potential environmental risks by performing a PDM as described above and in the "Exposure and Fate Assessment Screening Tool (E-FAST) Version 2.0 Documentation Manual (2007)", available at: http://www.epa.gov/opptintr/exposure/pubs/efast2man.pdf
[3] Bolded values represent those that may present an unreasonable risk of injury.
[4]The hazard value used is 1 ug/L.

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

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

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

Using the effect levels of 23 mg/kg-bw/day (for the MCCP PMNs: P-12-0282 and P-12-0283) or 100 mg/kg-bw/day (for the LCCP PMN [P-12-0284]), EPA/OPPT performed route-to-route extrapolations to develop HEDs for inhalation and dermal exposures in workers and for inhalation and oral exposures in the general population. EPA/OPPT did not assess oral exposures for workers, due to the unlikely nature of exposures occurring by this route. The respective HEDs served as the PODs for calculating MOEs, along with the previously reported estimated human exposure values for workers (Tables 15 and 17) and the general population (Tables 12 and 13).  An additional exposure scenario (consumers) was evaluated for the MCCPs and the exposure values used are reported in Table 18.

EPA/OPPT compared the MOEs to a benchmark value that consisted of a composite of three possible uncertainty factors (UFs): intraspecies variability (UFH; default value = 10), interspecies variability (UFA; default value = 10), and LOAEL-to-NOAEL extrapolation uncertainty (UFL; default value =10).  The LOAEL-to-NOAEL extrapolation was only used for P-12-0284 (LCCP). The UFH and UFA may each be subdivided to account for toxicokinetics (TK; default value = 3.16) and toxicodynamics (TD; default value = 3.16). When effect levels from experimental animal studies are converted to HEDs, EPA/OPPT's default approach is to reduce the TK sub factor of UFA to 1 (i.e., UFA = TK x TD = 1 x 3.16 ≈ 3).

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

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

HECINHAL-WORKER = (NOAELORAL or LOAELORAL) x (1/sRVrat) x (ABSoral-rat/ABSinh-human) x
(sRVhuman/wRVhuman)

where,

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

sRVrat = rat standard respiratory volume for 8-hours = 0.38 m[3]/kg-bw

ABS ORAL-RAT = percent absorption by the oral route in rats = 50%

ABS INHAL-HUMAN = percent absorption by inhalation in humans = 50%

sRV HUMAN = human standard respiratory volume for 8-hours = 6.7 m[3]

wRV = worker respiratory volume for 8-hours = 10 m[3]

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

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

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

where,

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

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

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

EPA/OPPT used the HECINHAL-WORKER and HEDDERM-WORKER values for calculating the respective MOEs using the estimated exposure values presented in Tables 15 (P-12-0282 and P-12-0283) and 17 (P-12-0284). As shown in Table 23, for one of the six occupational inhalation scenarios, the MOEs for the MCCPs (P-12-0282 and P-12-0283) was below the benchmark value of 30; which indicates a finding of potential risk to workers for that use; the two processing scenarios for which there were inhalation exposures suggested low risk. The single MOE less than 30 was 9.1, suggesting an APF of 10 would be sufficient to mitigate this risk.
The single scenario in which an exposure estimate resulted in a potential risk finding was for Use5; and only for the high-end exposure estimate. As noted in the footnote in Table 15, the high-end value is the EPA/OPPT Auto refinishing Spray Coating Model calculation. This is used to provide a conservative estimate to account for uncertainty in downstream uses. The footnote also provides a range of values from an EU monitoring study. Each of the three tasks in the monitoring study were performed in duplicate (i.e., apply a first coat, let it dry, and then apply a second coat). One individual performed all of the tasks (e.g., painting a fence). The highest measured value was had a time-weighted average of 0.19 mg/m[3]. Thus, there is no risk when the highest measured occupational exposure value is used; however, the modeled conservative value (47 times higher at 9 mg/m[3]) does suggest risk.

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

Table 23: Occupational MOEs for P-12-0282 and P-12-0283: Inhalation Exposures (Hazard POD [HEC] = 41 mg/m[3])[1]
Scenario
Modeled Exposure (mg/day)
                         Absorption Inhalation Human
                   Inhalation Rate, Workers, Eight
Hour/Day
                     Estimated Inhalation Exposure (mg/m3)
              Inhalation MOE (Risks Identified for MOEs < 30)
Proc 1
                                     0.03
                                      0.5
                                      10
                                    0.0015
                                     27333

                                      4.4
                                      0.5
                                      10
                                     0.22
                                      186
Proc 2
                                      0.1
                                      0.5
                                      10
                                     0.005
                                     8200

                                      0.7
                                      0.5
                                      10
                                     0.035
                                     1171
Use 1
                                      12
                                      0.5
                                      10
                                      0.6
                                      68

                                      15
                                      0.5
                                      10
                                     0.75
                                      55
Use 2
                                      0.7
                                      0.5
                                      10
                                     0.035
                                     1171

                                      15
                                      0.5
                                      10
                                     0.75
                                      55
Use 3
                                     0.98
                                      0.5
                                      10
                                     0.049
                                      837

                                      3.6
                                      0.5
                                      10
                                     0.18
                                      228
Use 5
                                    1.9[a]
                                      0.5
                                      10
                                     0.095
                                      432

                                     90[b]
                                      0.5
                                      10
                                      4.5
                                      9.1
[1] Proc 1 = Processing 1 = compounding of plastic products, Proc 2 = Processing 2 = compounding of rubber products, Use 1 = converting of plastic products, Use 2 = converting of rubber products, Use 3 = use of metal working fluids, Use 5 = use of paints, sealants, and adhesives.
Shaded rows are scenarios with risk findings.
[a] This value is the highest measured value in the occupational monitoring data EU risk assessment (ECB, 2008).
[b] This value is the high-end model estimate for auto-refinishing spray painting (47 times higher than the highest measured value).

In Table 24, the risk estimates for dermal exposures to P-12-0282 and P-12-0283, suggest there is low risk (i.e., all MOE values are well above the benchmark of 30).

Table 24: Occupational MOEs for P-12-0282 and P-12-0283: Dermal Exposures (Hazard POD [HED] = 4734 mg/kg-bw/day)
Scenario
                           Modeled Exposure (mg/day)
                                BW
(E-FASTV2)
                           Absorption Dermal Human
                   Estimated Dermal Exposure (mg/kg-bw/day)
               Dermal MOE  (Risks Identified for
MOEs < 30)
Mfg
                                     1100
                                     71.8
                                     0.01
                                     0.15
                                     30900

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
Proc 1
                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
Proc 2
                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
Proc 3
                                      220
                                     71.8
                                     0.01
                                     0.03
                                    154501

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
Proc 4
                                      90
                                     71.8
                                     0.01
                                     0.01
                                    377668

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
Proc 5
                                      340
                                     71.8
                                     0.01
                                     0.05
                                     99971

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
Use 3
                                      220
                                     71.8
                                     0.01
                                     0.03
                                    154501

                                      490
                                     71.8
                                     0.01
                                     0.07
                                     69368
Use 4
                                      90
                                     71.8
                                     0.01
                                     0.01
                                    377668
Use 5
                                      340
                                     71.8
                                     0.01
                                     0.05
                                     99971

                                     1300
                                     71.8
                                     0.01
                                     0.18
                                     26146
Use 6
                                      550
                                     71.8
                                     0.01
                                     0.08
                                     61800

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     15450
[1] Mfg = Manufacturing, Proc 1 = Processing 1 = compounding of plastic products, Proc 2 = Processing 2 = compounding of rubber products, Proc 3 = Processing 3 = formulation of metalworking fluids, Proc 4 = Processing 4 = formulation of engine oils, Proc 5 = Processing 5 = formulation of paints, sealants, and adhesives, Use 3 = use of metal working fluids, Use 4 = use of engine oils, Use 5 = use of paints, sealants, and adhesives, Use 6 = use in textiles.

Tables 25 and 26 present the occupational inhalation and dermal exposure scenario risk estimates for the LCCP (P-12-0284). LCCP has only one use (as a lubricant in MWF). Table 17 shows there are no inhalation exposures from either manufacturing or processing and so the only inhalation exposure scenario for LCCP is for its use as a lubricant. As see in Tables 25 and 26, the MOEs for P-12-0284 were above the benchmark value of 300; which suggests there is low risk to the exposed workers.

Table 25: Occupational MOEs for P-12-0284 (LCCP): Inhalation Exposures (Hazard POD [HEC] = 176 mg/m[3])[1]
Scenario
                                Exposure Route
                           Modeled Exposure (mg/day)
                         Absorption Inhalation Human
                  Inhalation Rate,  Workers, Eight
Hour/Day
                     Estimated Inhalation Exposure (mg/m3)
             Inhalation MOE  (Risks Identified for MOEs < 300)
Commercial Use of MWF
Inhalation
                                     0.98
                                      0.5
                                      10
                                     0.049
                                     3592

                                      3.6
                                      0.5
                                      10
                                     0.18
                                      978

Table 26: Occupational MOEs for P-12-0284 (LCCP): Dermal Exposures (Hazard POD [HED] = 20,583 mg/kg-bw/day)
Scenario
                                Exposure Route
                           Modeled Exposure (mg/day)
                                BW
(E-FASTV2)
                           Absorption Dermal Human
                   Estimated Dermal Exposure (mg/kg-bw/day)
               Dermal MOE  (Risks Identified for
MOEs < 300)
Manufacturing
(MWF)
Dermal
                                     1100
                                     71.8
                                     0.01
                                     0.15
                                    137220

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     66397
Processing MWF
Dermal
                                      220
                                     71.8
                                     0.01
                                     0.03
                                    686100

                                     2200
                                     71.8
                                     0.01
                                     0.31
                                     66397
Commercial Use of MWF
Dermal
                                   220 (liq)
                                     71.8
                                     0.01
                                     0.03
                                    686100

                                  490 (mist)
                                     71.8
                                     0.01
                                     0.07
                                    294043

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

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

where,

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

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

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

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

where,

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

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

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

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

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

EPA/OPPT used the HEDORAL-GENPOP and HECINHAL-GENPOP values for calculating the respective MOEs using the estimated exposure values presented in Tables 12 (MCCPs) and 13 (LCCP).
Tables 27, 28 and 29 present risk estimates for all drinking water and fish ingestion scenarios for P-12-0282, -0283 and -0284.  There is only one scenario (out of 76) for which there is a potential risk to the general population due to fish ingestion using the E-FAST modeling results (from exposure to P-12-0282 from the processing/formulation of plastics compounding). This scenario was further evaluated using the highest measured values of MCCPs in fish. The calculations, assumptions and results are also presented in Table 27. Using these measured values and high-end (95[th] percentile) fish intake assumptions, results in MOEs greater than 30 (i.e., 10,400).

For all other scenarios, the MOEs for P-12-0282, -0283, and -0284 all exceed the respective benchmark values, which indicate a finding of low risk to the general population from drinking water and fish ingestion exposures for environmental exposures that may occur due to the processes and uses evaluated in this assessment.

Table 27: General Population MOEs for P-12-0282:  Drinking Water/Fish Ingestion Risk Estimates (Hazard POD [HED] = 67.6 mg/kg-bw/day)

Scenario
                                Exposure Routes
                            Exposure (mg/kg bw/day)
                             Absorption Oral Human
                       Estimated Exposure (mg/kg bw/day)
                                      MOE
                         (Risks Identified if  <30)
Processing of Plastics Compounding (Proc1)
Drinking Water Ingestion
                                   9.44E-02
                                      0.5
                                     0.05
                                     1432

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

Fish Ingestion (m)[b]
                                   8.33E+00
                                      0.5
                                     4.165
                                      16
Use in Plastics Converting (Use1)
Drinking Water Ingestion
                                   2.36E-04
                                      0.5
                                   1.18E-04
                                    572881

Fish Ingestion
                                   1.91E-02
                                      0.5
                                   9.55E-03
                                     7079
Processing of Rubber Compounding (Proc2)
Drinking Water Ingestion
                                   4.56E-02
                                      0.5
                                    0.0228
                                     2965

Fish Ingestion
                                   4.02E+00
                                      0.5
                                     2.01
                                      34
Processing of MWF Oil-based (Proc3)
Drinking Water Ingestion
                                   1.91E-02
                                      0.5
                                    0.00955
                                     7079

Fish Ingestion
                                   1.69E+00
                                      0.5
                                     0.845
                                      80
Processing of MWF Water Based 50% Pretreatment (Proc3)
Drinking Water Ingestion
                                   1.09E-02
                                      0.5
                                   5.45E-03
                                     12404

Fish Ingestion
                                   9.70E-01
                                      0.5
                                     0.485
                                      139
Processing of MWF Water Based 70% Pretreatment (Proc3)
Drinking Water Ingestion
                                   6.61E-03
                                      0.5
                                   3.31E-03
                                     20454

Fish Ingestion
                                   5.80E-01
                                      0.5
                                     0.29
                                      233
Processing of MWF Water Based 99% Pretreatment (Proc3)
Drinking Water Ingestion
                                   2.15E-04
                                      0.5
                                   1.08E-04
                                    628837

Fish Ingestion
                                   1.90E-02
                                      0.5
                                   9.50E-03
                                     7116
Use of MWF
Oil based (Use3)
Drinking Water Ingestion
                                   5.65E-04
                                      0.5
                                   2.83E-04
                                    239292

Fish Ingestion
                                   2.94E-02
                                      0.5
                                    0.0147
                                     4599
Use of MWF Water Based 50% Pretreatment (Use3)
Drinking Water Ingestion
                                   2.79E-03
                                      0.5
                                   1.40E-03
                                     48459

Fish Ingestion
                                   1.50E-01
                                      0.5
                                     0.075
                                      901
Use of MWF Water Based 70% Pretreatment (Use3)
Drinking Water Ingestion
                                   1.68E-03
                                      0.5
                                   8.40E-04
                                     80476

Fish Ingestion
                                   8.73E-02
                                      0.5
                                    0.04365
                                     1549
Use of MWF Water Based 99% Pretreatment (Use3)
Drinking Water Ingestion
                                   5.67E-05
                                      0.5
                                   2.84E-05
                                    2384480

Fish Ingestion
                                   2.95E-03
                                      0.5
                                   1.48E-03
                                     45831
Processing of Engine Lubricants (Proc4)
Drinking Water Ingestion
                                   2.82E-03
                                      0.5
                                   1.41E-03
                                     47943

Fish Ingestion
                                   2.50E-01
                                      0.5
                                     0.125
                                      541
Processing of Paints, Sealants, and Adhesives (Proc5)
Drinking Water Ingestion
                                   1.20E-03
                                      0.5
                                   6.00E-04
                                    112667

Fish Ingestion
                                   1.10E-01
                                      0.5
                                     0.055
                                     1229
Use of Paints, Sealants, and Adhesives (Use5)
Drinking Water Ingestion
                                   1.11E-04
                                      0.5
                                   5.55E-05
                                    1218018

Fish Ingestion
                                   5.11E-03
                                      0.5
                                   2.56E-03
                                     26458
Use in Textile Finishing (Use6)
Drinking Water Ingestion
                                   1.20E-03
                                      0.5
                                   6.00E-04
                                    112667

Fish Ingestion
                                   1.10E-01
                                      0.5
                                     0.055
                                     1229
Shaded rows are scenarios with risk findings.
[a] B = "biota" to represent estimated fish ingestion based on highest reported levels of MCCPs in fish (i.e., 2.63 mg/kg-wet weight). See Table Apx_D-1-4 for levels of MCCPs in biota. Estimates for fish consumption is based on the Exposure Factors Handbook (US EPA, 2011). The highest 95[th] percentile value is used (4.9 grams of fish/kg-bw). The calculation for the three fish ingestion scenarios where modeled results suggest risk were refined using the following equation: 2.63 mg/kg-bw (MCCP concentration in fish) x 0.392 kg of fish intake = 1.03 mg/80 kg-bw = 0.013 mg/kg-bw.
[b]M = "modeled" to represent the estimated fish intake using E-FAST and associated assumptions. See Appendix F.

Table 28: General Population MOEs for P-12-0283:  Drinking Water/Fish Ingestion Risk Estimates (Hazard POD [HED] = 67.6 mg/kg-bw/day)

Scenario
                                Exposure Routes
                            Exposure (mg/kg bw/day)
                             Absorption Oral Human
                       Estimated Exposure (mg/kg bw/day)
                                      MOE
                         (Risks Identified if <30)
Processing of Plastics Compounding (Proc1)
Drinking Water Ingestion
                                   3.09E-02
                                      0.5
                                    0.01545
                                     4375

Fish Ingestion
                                   3.05E-02
                                      0.5
                                     0.02
                                     4433
Use in Plastics Converting (Use1)
Drinking Water Ingestion
                                   8.01E-05
                                      0.5
                                   4.01E-05
                                    1687890

Fish Ingestion
                                   7.27E-05
                                      0.5
                                   3.64E-05
                                    1859697
Processing of Rubber Compounding (Proc2)
Drinking Water Ingestion
                                   1.66E-02
                                      0.5
                                   8.30E-03
                                     8145

Fish Ingestion
                                   1.64E-02
                                      0.5
                                   8.20E-03
                                     8244
Processing of MWF Oil-based (Proc3)
Drinking Water Ingestion
                                   6.27E-03
                                      0.5
                                   3.14E-03
                                     21563

Fish Ingestion
                                   6.20E-03
                                      0.5
                                   3.10E-03
                                     21806
Processing of MWF Water Based 50% Pretreatment (Proc3)
Drinking Water Ingestion
                                   4.33E-03
                                      0.5
                                   2.17E-03
                                     31224

Fish Ingestion
                                   4.28E-03
                                      0.5
                                   2.14E-03
                                     31589
Processing of MWF Water Based 70% Pretreatment (Proc3)
Drinking Water Ingestion
                                   2.59E-03
                                      0.5
                                   1.30E-03
                                     52201

Fish Ingestion
                                   2.56E-03
                                      0.5
                                   1.28E-03
                                     52813
Processing of MWF Water Based 99% Pretreatment (Proc3)
Drinking Water Ingestion
                                   8.72E-05
                                      0.5
                                   4.36E-05
                                    1550459

Fish Ingestion
                                   8.62E-05
                                      0.5
                                   4.31E-05
                                    1568445
Use of MWF
Oil based (Use3)
Drinking Water Ingestion
                                   5.65E-04
                                      0.5
                                   2.83E-04
                                    239292

Fish Ingestion
                                   3.29E-04
                                      0.5
                                   1.65E-04
                                    410942
Use of MWF Water Based 50% Pretreatment (Use3)
Drinking Water Ingestion
                                   2.79E-03
                                      0.5
                                   1.40E-03
                                     48459

Fish Ingestion
                                   1.63E-03
                                      0.5
                                   8.15E-04
                                     82945
Use of MWF Water Based 70% Pretreatment (Use3)
Drinking Water Ingestion
                                   1.68E-03
                                      0.5
                                   8.40E-04
                                     80476

Fish Ingestion
                                   9.78E-04
                                      0.5
                                   4.89E-04
                                    138241
Use of MWF Water Based 99% Pretreatment (Use3)
Drinking Water Ingestion
                                   5.67E-05
                                      0.5
                                   2.84E-05
                                    2384480

Fish Ingestion
                                   3.30E-05
                                      0.5
                                   1.65E-05
                                    4096970
Processing of Engine Lubricants (Proc4)
Drinking Water Ingestion
                                   8.83E-04
                                      0.5
                                   4.42E-04
                                    153114

Fish Ingestion
                                   8.74E-04
                                      0.5
                                   4.37E-04
                                    154691
Processing of Paints, Sealants, and Adhesives (Proc5)
Drinking Water Ingestion
                                   1.13E-03
                                      0.5
                                   5.65E-04
                                    119646

Fish Ingestion
                                   1.12E-03
                                      0.5
                                   5.60E-04
                                    120714
Use of Paints, Sealants, and Adhesives (Use5)
Drinking Water Ingestion
                                   1.10E-04
                                      0.5
                                   5.50E-05
                                    1229091

Fish Ingestion
                                   5.73E-05
                                      0.5
                                   2.87E-05
                                    2359511
Use in Textile Finishing (Use6)
Drinking Water Ingestion
                                   1.20E-03
                                      0.5
                                   6.00E-04
                                    112667

Fish Ingestion
                                   1.18E-03
                                      0.5
                                   5.90E-04
                                    114576

Table 29: General Population MOEs for P-12-0284:  Drinking Water/Fish Ingestion Risk Estimates (Hazard POD [HED] = 294 mg/kg-bw/day)

Scenario
                                Exposure Routes
                            Exposure (mg/kg bw/day)
                            Absorption Oral Human
                       Estimated Exposure (mg/kg bw/day)
                                      MOE
                         (Risks Identified if <300)
MWF Formulation Oil Based
Drinking Water Ingestion
                                   1.06E-03
                                      0.5
                                    0.0005
                                    554717

Fish Ingestion
                                   9.36E-02
                                      0.5
                                    0.0468
                                     6282
MWF Formulation Water Based 50% Pretreatment
Drinking Water Ingestion
                                   7.84E-04
                                      0.5
                                    0.0004
                                    750000

Fish Ingestion
                                   6.92E-02
                                      0.5
                                    0.0346
                                     8497
MWF Formulation Water Based 70% Pretreatment
Drinking Water Ingestion
                                   4.79E-04
                                      0.5
                                    0.0002
                                    1227557

Fish Ingestion
                                   4.23E-02
                                      0.5
                                    0.0212
                                     13901
MWF Formulation Water Based 99% Pretreatment
Drinking Water Ingestion
                                   1.60E-05
                                      0.5
                                    0.0000
                                   36750000

Fish Ingestion
                                   1.41E-03
                                      0.5
                                    0.0007
                                    417021
Use of MWF Oil based
Drinking Water Ingestion
                                   5.65E-04
                                      0.5
                                    0.0003
                                    1040708

Fish Ingestion
                                   2.94E-02
                                      0.5
                                    0.0147
                                     20000
Use of MWF Water Based 50% Pretreatment
Drinking Water Ingestion
                                   2.79E-03
                                      0.5
                                    0.0014
                                    210753

Fish Ingestion
                                   1.50E-01
                                      0.5
                                    0.0750
                                     3920
Use of MWF Water Based 70% Pretreatment
Drinking Water Ingestion
                                   1.69E-03
                                      0.5
                                    0.0008
                                    347929

Fish Ingestion
                                   8.77E-02
                                      0.5
                                    0.0439
                                     6705
Use of MWF Water Based 99% Pretreatment
Drinking Water Ingestion
                                   5.67E-05
                                      0.5
                                   0.000028
                                   10370370

Fish Ingestion
                                   2.95E-03
                                      0.5
                                    0.0015
                                    199322

Tables 30, 31 and 32 present the findings from estimating risk to the general population following inhalation exposure to each of the three PMN substances from either stack air or fugitive emissions. For all scenarios, the MOEs for P-12-0282, -0283, and -0284 all exceed the respective benchmark values, which indicate a finding of low risk to the general population from inhalation exposures (from either stack or fugitive sources of environmental release) that may occur due to the manufacturing, processing, and uses evaluated in this assessment.

Table 30: General Population MOEs for P-12-0282:  Inhalation Exposure to Stack/Fugitive Air Risk Estimates (Hazard POD [HEC] = 14.3 mg/m[3])
                                   Scenario
                        (Either Stack or Fugitive Air)
                       Exposure Concentration (mg/m[3])
                          Absorption Inhalation Human
                                   (Percent)
                   Estimated Exposure Concentration (mg/m3)
                       MOE (Risks Identified if <30)
Manufacturing Stack Air
                                   2.76E-03
                                      0.5
                                   1.38E-03
                                     10362
Processing of Plastics Compounding - Stack Air (Proc1)
                                   2.34E-03
                                      0.5
                                   1.17E-03
                                     12222
Processing of Plastics Compounding  -  Fugitive (Proc1)
                                   1.91E-02
                                      0.5
                                   9.55E-03
                                     1497
Use in Plastics Converting - Stack Air (Use1)
                                   2.40E-04
                                      0.5
                                   1.20E-04
                                    119167
Use in Plastics Converting  -  Fugitive (Use1)
                                   1.10E-01
                                      0.5
                                   5.50E-02
                                      260
Processing of Rubber Compounding - Stack Air (Proc2)
                                   1.20E-03
                                      0.5
                                   6.00E-04
                                     23833
Processing of Rubber Compounding  -  Fugitive (Proc2)
                                   1.22E-03
                                      0.5
                                   6.10E-04
                                     23443
Use in Rubber Converting - Stack Air (Use2)
                                   5.72E-05
                                      0.5
                                   2.86E-05
                                    500000
Processing of MWF Oil Based - Stack Air (Proc3)
                                   6.20E-04
                                      0.5
                                   3.10E-04
                                     46129
Processing of MWF Oil Based - Stack Fugitive (Proc3)
                                   5.74E-03
                                      0.5
                                   2.87E-03
                                     4983
Processing of MWF Water Based 50% Pretreatment - Stack Air (Proc3)
                                   3.30E-04
                                      0.5
                                   1.65E-04
                                     86667
Processing of MWF Water Based 50% Pretreatment  -  Fugitive (Proc3)
                                   5.74E-03
                                      0.5
                                   2.87E-03
                                     4983
Processing of MWF Water Based 70% Pretreatment - Stack Air (Proc3)
                                   2.70E-04
                                      0.5
                                   1.35E-04
                                    105926
Processing of MWF Water Based 70% Pretreatment  -  Fugitive (Proc3)
                                   5.74E-03
                                      0.5
                                   2.87E-03
                                     4983
Processing of MWF Water Based 99% Pretreatment - Stack Air (Proc3)
                                   1.20E-04
                                      0.5
                                   6.00E-05
                                    238333
Processing of MWF Water Based 99% Pretreatment  -  Fugitive (Proc3)
                                   5.74E-03
                                      0.5
                                   2.87E-03
                                     4983
Use of MWF Oil Based - Stack Air (Use3)
                                   4.73E-05
                                      0.5
                                   2.37E-05
                                    604651
Use of MWF Water Based 50% Pretreatment - Stack Air (Use3)
                                   2.09E-05
                                      0.5
                                   1.05E-05
                                    1368421
Use of MWF Oil Based 70% Pretreatment - Stack Air (Use3)
                                   1.26E-05
                                      0.5
                                   6.30E-06
                                    2269841
Use of MWF Oil Based 99% Pretreatment - Stack Air (Use3)
                                   4.30E-07
                                      0.5
                                   2.15E-07
                                   66511628
Processing of Engine Lubricants - Stack Air (Proc4)
                                   9.77E-05
                                      0.5
                                   4.89E-05
                                    292733
Use of Engine Lubricants - Stack Air (Use4)
                                   8.82E-05
                                      0.5
                                   4.41E-05
                                    324263
Processing of Paints, Sealants, and Adhesives - Stack Air (Proc5)
                                   2.48E-03
                                      0.5
                                   1.24E-03
                                     11532
Use of Paints, Sealants, and Adhesives - Stack Air (Use5)
                                   3.80E-07
                                      0.5
                                   1.90E-07
                                   75263158
Use of Paints, Sealants, and Adhesives  -  Fugitive (Use5)
                                   2.05E-02
                                      0.5
                                   1.03E-02
                                     1395
Use in Textile Finishing - Stack Air (Use6)
                                   2.09E-05
                                      0.5
                                   1.05E-05
                                    1368421

Table 31: General Population MOEs for P-12-0283:  Inhalation Exposure to Stack/Fugitive Air Risk Estimates (Hazard POD [HEC] = 14.3 mg/m[3])

                                   Scenario
                        (Either Stack or Fugitive Air)
                       Exposure Concentration (mg/m[3])
                          Absorption Inhalation Human
                                   (Percent)
                   Estimated Exposure Concentration (mg/m3)
                                      MOE
                         (Risks Identified if <30)
Manufacturing Stack Air
                                   2.76E-03
                                      0.5
                                   1.38E-03
                                     10362
Processing of Plastics Compounding - Stack Air (Proc1)
                                   8.40E-04
                                      0.5
                                   4.20E-04
                                     34048
Processing of Plastics Compounding  -  Fugitive (Proc1)
                                   2.87E-02
                                      0.5
                                   1.44E-02
                                      997
Use in Plastics Converting - Stack Air (Use1)
                                   7.56E-05
                                      0.5
                                   3.78E-05
                                    378307
Use in Plastics Converting  -  Fugitive (Use1)
                                   3.42E-02
                                      0.5
                                   1.71E-02
                                      836
Processing of Rubber Compounding - Stack Air (Proc2)
                                   5.10E-04
                                      0.5
                                   2.55E-04
                                     56078
Processing of Rubber Compounding  -  Fugitive (Proc2)
                                   1.22E-03
                                      0.5
                                   6.10E-04
                                     23443
Use in Rubber Converting - Stack Air (Use2)
                                   1.82E-05
                                      0.5
                                   9.10E-06
                                    1571429
Processing of MWF Oil Based - Stack Air (Proc3)
                                   3.20E-04
                                      0.5
                                   1.60E-04
                                     89375
Processing of MWF Oil Based - Stack Fugitive (Proc3)
                                   5.88E-03
                                      0.5
                                   2.94E-03
                                     4864
Processing of MWF Water Based 50% Pretreatment - Stack Air (Proc3)
                                   2.00E-04
                                      0.5
                                   1.00E-04
                                    143000
Processing of MWF Water Based 50% Pretreatment  -  Fugitive (Proc3)
                                   5.88E-03
                                      0.5
                                   2.94E-03
                                     4864
Processing of MWF Water Based 70% Pretreatment - Stack Air (Proc3)
                                   1.80E-04
                                      0.5
                                   9.00E-05
                                    158889
Processing of MWF Water Based 70% Pretreatment  -  Fugitive (Proc3)
                                   5.88E-03
                                      0.5
                                   2.94E-03
                                     4864
Processing of MWF Water Based 99% Pretreatment - Stack Air (Proc3)
                                   1.20E-04
                                      0.5
                                   6.00E-05
                                    238333
Processing of MWF Water Based 99% Pretreatment  -  Fugitive (Proc3)
                                   5.88E-03
                                      0.5
                                   2.94E-03
                                     4864
Use of MWF Oil Based - Stack Air (Use3)
                                   4.73E-05
                                      0.5
                                   2.37E-05
                                    604651
Use of MWF Water Based 50% Pretreatment - Stack Air (Use3)
                                   2.09E-05
                                      0.5
                                   1.05E-05
                                    1368421
Use of MWF Oil Based 70% Pretreatment - Stack Air (Use3)
                                   1.26E-05
                                      0.5
                                   6.30E-06
                                    2269841
Use of MWF Oil Based 99% Pretreatment - Stack Air (Use3)
                                   4.30E-07
                                      0.5
                                   2.15E-07
                                   66511628
Processing of Engine Lubricants - Stack Air (Proc4)
                                   4.92E-05
                                      0.5
                                   2.46E-05
                                    581301
Use of Engine Lubricants - Stack Air (Use4)
                                   8.82E-05
                                      0.5
                                   4.41E-05
                                    324263
Processing of Paints, Sealants, and Adhesives - Stack Air (Proc5)
                                   2.00E-03
                                      0.5
                                   1.00E-03
                                     14300
Use of Paints, Sealants, and Adhesives - Stack Air (Use5)
                                   3.80E-07
                                      0.5
                                   1.90E-07
                                   75263158
Use of Paints, Sealants, and Adhesives  -  Fugitive (Use5)
                                   2.05E-02
                                      0.5
                                   1.03E-02
                                     1395
Use in Textile Finishing - Stack Air (Use6)
                                   2.09E-05
                                      0.5
                                   1.05E-05
                                    1368421

Table 32: General Population MOEs for P-12-0284:  Inhalation Exposure to Stack/Fugitive Air Risk Estimates (Hazard POD [HEC] = 62 mg/m[3])
Scenario
Exposure Concentration (mg/m[3])
Absorption Inhalation Human
Estimated Exposure Concentration (mg/m3)
                       MOE (Risks Identified if <300)
Manufacturing Stack Air
                                   2.76E-03
                                      0.5
                                   1.38E-03
                                     44928
MWF Formulation Oil Based - Stack Air
                                   6.34E-05
                                      0.5
                                   3.17E-05
                                    1955836
MWF Formulation Oil Based - Fugitive Air
                                   1.28E-03
                                      0.5
                                   6.40E-04
                                     96875
MWF Formulation Water Based 50% Pretreatment - Stack Air
                                   4.41E-05
                                      0.5
                                   2.21E-05
                                    2811791
MWF Formulation Water Based 50% Pretreatment - Fugitive Air
                                   1.28E-03
                                      0.5
                                   6.40E-04
                                     96875
MWF Formulation Water Based 70% Pretreatment - Stack Air
                                   3.69E-05
                                      0.5
                                   1.85E-05
                                    3360434
MWF Formulation Water Based 70% Pretreatment - Fugitive Air
                                   1.28E-03
                                      0.5
                                   6.40E-04
                                     96875
MWF Formulation Water Based 99% Pretreatment - Stack Air
                                   2.60E-05
                                      0.5
                                   1.30E-05
                                    4769231
MWF Formulation Water Based 99% Pretreatment - Fugitive Air
                                   1.28E-03
                                      0.5
                                   6.40E-04
                                     96875
Use of MWF Oil based - Stack Air
                                   4.73E-05
                                      0.5
                                   2.37E-05
                                    2621564
Use of MWF Water Based 50% Pretreatment - Stack Air
                                   2.09E-05
                                      0.5
                                   1.05E-05
                                    5933014
Use of MWF Water Based 70% Pretreatment - Stack Air
                                   1.27E-05
                                      0.5
                                   6.35E-06
                                    9763780
Use of MWF Water Based 99% Pretreatment - Stack Air
                                   4.30E-07
                                      0.5
                                   2.15E-07
                                   288372093

Consumer
The consumer use assessed in this assessment is for dermal exposure to used motor oil for the MCCP PMNs (P-12-0282 and P-12-0283). Table 18 presents the value/assumptions used to estimate exposures for this scenario, which is approximately 25 mg/kg-bw/day.

Using the same approach described above for assessing dermal exposures to workers, EPA/OPPT calculated the HED values for dermal exposures to consumers (i.e., HEDDERM-CONSUMER) based on the following equation:

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

where,

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

The resulting HEDDERM-CONSUMER value equals 4734 mg/kg-bw/day for the MCCP congener.

Using an absorption factor of 1 % for the dermal exposure value results in an exposure estimate of 0.01 x 25 = 0.25 mg/kg-bw/day; which is then used to determine the MOE of 4734/0.25 = 18,936. This value is well above the benchmark MOE of 30, showing low risk to consumers from this use.

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.

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APPENDICES

ENVIRONMENTAL FATE AND BIOACCUMULATION STUDY SUMMARIES

ENVIRONMENTAL PERSISTENCE
Abiotic Degradation
Generally, CPs are stable to hydrolysis and to direct photolysis in air and water, though very limited data exist on hydrolysis and direct and indirect photolysis in soil, water, or air. In studies using aliphatic hydrocarbon solvents, CPs were shown to be poor absorbers of UV light and no direct photodegradation was observed (Friedman and Lombardo, 1975; Lombardo et al., 1975). Koh and Thiemann (2001) studied photolysis of aqueous solutions for CPs products with chain lengths ranging from C10 to C24 including an MCCP product, Hoechst CP52, with chain lengths from C12 to C18 and an average of 52 wt % Cl. A mercury vapor lamp with main radiation wavelengths of 254, 302, 313, 366,405/408, and 436 was used in batch experiments. Following a 5 hour radiation time, estimated atmospheric degradation rates showed photolysis half-lives of less than 20 hours based on measurement of free chloride and analysis of degradation products. The MCCP product had a T1/2 of 12.8 hour in aqueous solution. The addition of peroxide or acetone increased the photolysis rate suggesting that indirect photolysis may be significant. The authors also reported that longer chain CPs were formed during this study and speculated that recombination of smaller alkyl radicals could occur under some conditions.

Thermal degradation data for MCCPs and LCCPs are limited, but studies of SCCPs and Polyvinyl chlorides suggest MCCPs are degraded rapidly at 250 - 350 °C (Bergman et al., 1984). Dehydrohalogenation may lead to the formation of a large number of aliphatic and aromatic compounds. Chlorine radical formation can lead to production of highly chlorinated aromatics including polychlorinated biphenyls. Higher Cl content results in production of greater numbers and amounts of chlorinated aromatics (Bergman et al., 1984).
Fate in Air
As noted above, CPs lack structural components that absorb light in the UV or visible spectrum, so direct photolysis is not expected to occur. The atmospheric half-life 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 with lower chlorine contents between 40 and 56 wt %. EPA/OPPT also estimated atmospheric half-lives for MCCPs (40 and 70 Cl wt %) calculated using EPI Suite(TM)/AOPWIN(TM) (v. 1.92a) that range from about 1 to > 4 days (see Table_Apx A-1). MCCPs with the shorter chain lengths and higher chlorine contents were calculated to be more persistent.

MCCPs have low estimated vapor pressures (4.5 x 10[-8] to 2.27 x 10[-3] Pa at 20 - 25°C) and a Henry's law constant (HLC) (0.014 - 51.3 Pa x m[3]/mol for C14-17 congener groups) and are not expected to partition to air. They may be transported associated with particulate matter, and have been reported in indoor and outdoor air and house dust (Barber et al., 2005; Fridén et al., 2011; Hilger et al., 2013). Wide spread soil contamination and occurrence in artic samples suggest that MCCPs behave similarly to other chlorinated persistent organic pollutants (POPs) with high production volumes and releases, and are subject to long range transport (Dick et al., 2010; Medeiros et al., 2011; Tomy et al., 2000).

Table_Apx A-1: Estimated Atmospheric Half Lives Using EPI Suite(TM)/AOPWIN(TM) (v. 1.92a) for Varying MCCP Chain Length and Chlorination Percents Based on Wt.
                                 Chain Length
                                  40 Cl Wt %
                                  70 Cl Wt %
                                      C14
                                      1.0
                                      4.4
                                      C15
                                      0.8
                                      3.0
                                      C16
                                      0.8
                                      3.0
                                      C17
                                      0.8
                                      2.9

Biodegradation
EPA/OPPT reviewed studies from the open literature and submitted to EPA/OPPT including those described in the Canada and EU assessments and referenced in Table_Apx A-2 (EC, 2008a; ECB, 2005) to determine biodegradation under a variety of environmental conditions. Some of these studies used modified test conditions to enhance or maximize biodegradation. EPA/OPPT concurs with the EU's conclusions that under these modified test conditions, C14 41.3 % by wt. Cl and a C14 45.5% by wt. Cl substances are readily biodegradable. C 15 51% by wt. Cl were found to be inherently degradable and possibly readily degradable in modified OECD 301 and 301D tests. This suggests that CPs with these chain lengths and shorter, and this degree of chlorination and lower, are inherently degradable. More highly chlorinated and longer carbon chain CPs (C14-17 51.7 % by wt. Cl, C14 55 % by wt. Cl, C14 60.2% by wt. Cl, and C14 -17 63.2% by wt. Cl) biodegraded over a range of 2  -  54% in 28 days to 4  -  57% at up to 60 days. The most highly chlorinated, (C14-17, 63.2 wt% Cl) biodegraded 5% in 28 days and 10% at 60 days in the enhanced biodegradation studies, suggesting that longer chain and higher chlorination can contribute to greater persistence under most environmental conditions. (Van Ginkel, 2014 a and b; Van Ginkel 2010 a-d; Van Ginkel and Louwerse 2010 a and b)

Fate in Wastewater Treatment
In its review of the available measured data on MCCPs in wastewater treatment from data in from other countries, EPA/OPPT determined that CPs are present in the majority of municipal waste water treatment plant (WWTP) influent (Coelhan, 2010; Nicholls et al., 2001; Stevens et al., 2003; Zeng et al., 2013). Low water solubility and relatively high partitioning coefficients suggest that most of the MCCPs and LCCPs entering WWTP systems will associate with solids. Some biodegradation of shorter chain, lower chlorinated MCCP congener groups may occur, while longer chain length, more chlorinated congener groups will be resistant to aerobic and anaerobic degradation. Shorter and lower chlorinated congener groups have higher vapor pressure and may be lost to the vapor phase during aeration. WWTP effluent also contains some particulate-associated MCCPs. Because of their low water solubility, little MCCP or LCCP will be in the dissolved phase, and the majority will be removed along with settled sludge. Once associated with the sludge, the CPs will generally be stable in sludge treatment and remain in the residual biosolids. Land application of biosolids will transfer the MCCPs and LCCPs to agricultural and other soils (Nicholls et al., 2001; Stevens et al., 2003). Because 50 - 60% of biosolids in the US are land applied, the majority of MCCPs and LCCPs entering WWTPs may be released to the environment via application to soil, and may be transported from contaminated soil to other locations and media by soil erosion, runoff, and wind borne particulates, and volatilization.
Fate in Surface Water, Sediments and Groundwater
Because they generally have low water solubility, high sorption coefficients, and tend to partition to solids, MCCPs and LCCPs released to surface water will partition to surficial sediment where they may be buried and removed from potential degradation processes. This explains what is found in the limited monitoring data that exist - MCCP concentrations in surface water are generally in the low pg/L range, while sediment concentrations are several orders of magnitude higher (EC, 2008a). The presence could also be partially due to the general observation of slower rates of biodegradation under anaerobic conditions, as can occur in sediments, than under aerobic conditions (Boethling et al. 1995). Applying this observation to the rates of aerobic biodegradation for certain MCCPs reported elsewhere in this document suggests they may be persistent or very persistent in anaerobic environments.

MCCPs may leach from soil and be transported to groundwater, but low solubility and high sorption will act to keep dissolved concentrations very low. Facilitated transport with colloids and particulates may occur so that MCCPs can be transported in groundwater, but in general, concentrations in this compartment are expected to be very low. MCCPs that are introduced to groundwater will tend to partition to the solid phase and not be mobile.
Fate in Soil