## Support Documents for Significant New Use Rules (SNUR) on Premanufacture Notice (PMN) P-11-160

EPA Docket EPA-HQ-OPPT-2012-0450

## Index A-001 Structure Activity Team (SAT) Report for PMN P-11-160 A-002 Initial Review Engineering Report for PMN P-11-160 A-003 Post Focus Exposure Report for PMN P-11-160 A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-11-160

## A-001 Structure Activity Team (SAT) Report for PMN P-11-160

### SAT Report PMN Number: P-11-0160 SAT Date: 2/1/2011 Print Date: 3/2/2012
Related cases : Health related cases: Ecotox related cases :

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 1 3

Persistence Bioaccum Toxicity Comments 1 11

Exposure Based Review : Health: Yes Ecotox: Yes Routes of exposure : Health: N o exposures needed Ecotox: All releases to water Fate: ; Keywords : Keywords: Summary of Assessment : Fate : Fate Summary: P-11-0160 FATE: Estimations for typical Liquid with MP < 25 C (E) log Kow = 5.27 (E) S = 1.14 mg/L at 25 C (E) VP = 2.9E-5 torr at 25 C (E) BP = 378 C (E) H < 1.00E-8 (E) log Koc = 4.24 (E) log Fish BCF = 1.77 (E)log Fish BAF = 1.09 (E) POTW removal (%) = 90 via sorption and biodeg; 92/69/EEC Method C.4-D(Mano Resp): 83%/28d. Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = strong PBT Potential: P1B1 *CEB FATE: Migration to ground water = slow
Health : Health Summary: Expect poor absorption via all routes ( p che m ). N o significant health concerns. Test Data: (-) Salmonella with and without activation; rat oral LD0 = 2000 mg/kg; slight eye irritation in rabbits; slight skin irritation in rabbits, cleared by 72 hours; rat 28-day oral NOEL = 1000 mg/kg (highest dose tested) Ecotox : Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 0.66 >100 invalid test daphnid 48-h LC50 0.88 >100 invalid test green algal 96-h EC50 0.26 >100 invalid test fish

_ chronic value 0.027 daphnid

_ chronic value 0.24 algal

_ chronic value 0.19 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for SAR chemical class = log Kow = 5.27 (EPI, major product); MW major product); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L; Ecotoxicity Study Review for
PMN P11-0160 Synonyms: N one listed Trade Names: Test Lab Designation: Three acute ecotoxicity studies were conducted with this PMN (P11-0160) in 2007 by with fish, daphnia, andalgae. .” Thus, it can be concluded that the in the neat state at room temperature with a purity of 93.8% for the 4 major components. The has an estimated water solubility of 0.11 mg/L, an estimated log Kow of 5.27, and an estimated vapor pressure of 0.00029 mmHg at 25°C.
The After adding the , the was blended at high speed (8,000 rpm) with an Ultra Turax blender for 60 seconds. Following this, the was stirred for 24 hours using a magnetic stirrer. Undissolved particles of the test material were removed first by filtration using a folded filter with a pore size of 7

–12 um. Remaining particles were removed using an aseptic filter with p ore size of 0.45 um. Attempts to measure the in the test media by gas chromatography with a MS detector had limited success due to the low water solubility of the test material. The stated Limit of Determination was “< 0.062 mg/L” ( p resumably this means “0.062 mg/L”). Lack of detection was almost certainly due to the negligible and possible removal from the aqueous test media by sorption onto the glass vessel walls and filters. Thus, concentrations were not reported as measured but as nominal loading rates. All three tests were run under static or semi-static conditions. In a static limit test, fasted Zebra Fish (Brachydanio rerio) (7 fish/concentration) were exposed to nominal concentrations of 0 or 100 mg/L for 96 hours without aeration. Over the course of exposures, water temperature ranged from 21.3-22.9°C; p H ranged fro m 7.5

–7.9; O2 levels ranged from 7.3

–9.4 mg/L; water hardness was 259 mg as CaCO3/L and electrical conductivity was not reported. The 96-hour LC50 for fish was >100 mg/L (nominal); the LOEC was >100; and the NOEC was 100 mg/L. N o deaths or adverse effects occurred in the control or treated fish. In a 48-hour immobilization limit test, fasted Daphnia magna (5 daphnia/replicate x 4 replicates) were exposed to nominal concentrations of 0 or 100 mg/L under semi-static conditions (24-hr renewal interval) for a total of 48 hours without aeration. Over the course of the study, temperature was maintained at 20.6

–21.3°C; p H ranged fro m 7.8

–8.1; O2 levels ranged from 8.0

–8.8 mg/L; water hardness was 268 mg CaCO3/L and conductivity was not reported. The 48-hour EC50 for daphnia was > 100 mg/L (nominal) with no confidence limits determinable. The LOEC for mortality and immobilization was >100 mg/L and the NOEC was 100 mg/L as nominal concentrations. Abnormal swimming behavior was observed in 20 of 20 daphnids at 24 hours and 13 of 20 at 48 hours. In this test, low concentrations were detected and quantifiable at the beginning of the test and the beginning of the renewal period (second 24 hrs) but not at the end of the 24 hr periods. These levels represented 0.22

–0.43% of nominals (i.e., 0.22 to 0.43 mg/L). In a 72-hour test for algal growth inhibition, an initial cell concentration of 5.0E+3 cells/ml of Scenedesmus subspicatus was incubated with the PMN at nominal concentrations of 0, 4.3, 9.4, 21, 45, or 100 mg/L (not serially diluted) under static conditions (24 hour renewal intervals) for72 hours (3 replicates for both control and treated groups). Corresponding mean measured concentrations were not determined due to lack of analytical sensitivity (LOQ < 0.061 mg/L). All reported nominal concentrations were above this upper limit estimate of water solubility. Cells were exposed continuously to white light with a wavelength between 400

–700 nm with an intensity ranging from 4,000

–8,000 Lux, with constant swirling (125 rpm) at 23 - 25°C. The p H ranged fro m 8.0 to 9.3; O2 levels were not reported; water hardness and test medium conductivity were not reported. The test was conducted in 250 ml Erlenmeyer flasks containing 100 ml of test solution. Cell growth was measured by a particle cell counter and using uptake of a fluorescent dye. This test met validity criteria: algal growth exceeded 16-fold over the 72-hr course of exposure in controls, the coefficient of variation of daily growth rates in controls did not exceed 35%, and the coefficient of variation of average growth in replicate control cultures did not exceed 7%. The 72-hr EbC50 for inhibition of biomass (area under curve), measured as nominal concentrations, was 172 mg/L (95% CL: 153-209) with a projected NOEC > 100 mg/L. The 72-hr ErC50 for growth rate, measured as nominal concentrations, was > 561 mg/L (95% CL: 338-1,883 mg/L) and the NOEC was projected to be greater than 100 mg/L. As in the daphnia assay, very low concentrations were quantifiable at the beginning of exposures but fell to below detection (i.e., < 0.061 mg/L) by the end of the exposure period. The three acute ecotoxicity studies are considered invalid due to uncertainty regarding exposure concentrations. In these acute assays, the PMN substance does not show significant toxicity. However, the appropriateness of conducting acute toxicity test to evaluate a test material of such low water solubility is questionable. This is because EC50 values for daphnia and algae and the LC50 value for fish are reported at concentrations significantly higher than the estimated water solubility limit of the PMN (i.e., 0.11 mg/L). It may have been better to conduct chronic toxicity tests such as the 21-day daphnia reproduction assay and the fish early life-stage test wherein the PMN would have more time to equilibrate with the test media and biota to yield a more meaningful test of ecotoxicity. This would include: 1) Fish Early Life-Stage OCSPP 850.1400 using if possible, the flow-through method, with mean measured concentrations, p rotocol review, and a certificate of analysis, a.k.a., OECD 210 and; 2) Chronic Daphnia OCSPP 850.1300 using if possible, the flow-through method, mean measured concentrations, p rotocol review, certificate of analysis, aka OECD 211. Perhaps better, tests for toxicity to benthic organisms would be best since the PMN substance shows such a strong tendency to sorb to organic and inorganic matter (e.g., OECD 233 or EPA 850.1735, .1740, .1790, etc). Because of these limitations, ECOSAR predictions will be relied upon to determine the concentration of concern (COC). ECOSAR predicts a chronic COC of 3 μg/L ( p pb) based on estimated fish toxicity. An acute COC may be derived from the predicted algae LC50 of 0.26 mg/L by dividing this value by the default acute to chronic ratio of 4, yielding 0.065 mg/L or 65 μg/L ( p pb). Ecotox Study Reviewer: S. Cragg 1 February 2011 Factors Values Comments Assessment Factor 10 Concentration of Concern 3( p pb) SARs SAR Class new chemicals category: Ecotox Category Ecotox Factors Comments: SAT Chair: L Keifer 564-8916

## A-002 Initial Review Engineering Report for PMN P-11-160file:///J|/INITENG/P11%20cases/p110160eng.txt[3/2/2012 8:23:18 AM] INITIAL REVIEW ENGINEERING REPORT PMN: 11-0160 Focus Ready Draft 2/10/2011 ENGINEER: El-Zoobi \ JD PV (kg/yr):

SUBMITTER: USE:

OTHER USES:

CRSS :file:///J|/INITENG/P11%20cases/p110160eng.txt[3/2/2012 8:23:18 AM] Consumer Use: SAT (concerns) (02/01/2011): Related Cases and Related Cases and Misc SAT Info: Analogs: ; On TSCA: Migration to groundwater: PBT rating: P1B1T1 . Health: 1 Eco: 3 Water (All releases to water with a CC = 3.00 ppb) OCCUPATIONAL EXPOSURE RATING: 2-3B NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS: P2 Claims:

EXPOSURE-BASED REVIEW: Yes (0 criteria met)file:///J|/INITENG/P11%20cases/p110160eng.txt[3/2/2012 8:23:18 AM] 1) # of workers exposed: 48 >1000? No 2) >100 workers with >10 mg/day inhalation exposure: No 3) (a) >100 workers w/1-10 mg/day inh. exp. & >100 days/yr: No (b) Routine Dermal Cont: >250 workers & >100 days/yr: No INITIAL REVIEW ENGINEERING REPORT PMN: 11-0160 Processing: Number of Sites/ Location: 1 Berry Plastics Corporation Calhoun GA 30701 Days/yr: 250 Basis:

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources to the same medium.
Water Output 2: 2.0E-3 kg/site-day over 250 days/yr from 1 site to: City Water System for treatment (per submission). from: Water Cooling basis: EPA/OPPT Water Saturation Loss Model. Water or Incineration or Landfill Conservative: 3.6E+1 kg/site-day over 250 days/yr from 1 site

Water or Incineration or Landfill High End: 5.4E+1 kg/site-day over 250 days/yr from 1 sitefile:///J|/INITENG/P11%20cases/p110160eng.txt[3/2/2012 8:23:18 AM] OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 48 Basis: Submission does not estimate number of workers.

Inhalation: Exposure to Particulate (Class I) Upper Bound: 3.9E+1 mg/day over 250 days/yr Number of workers (all sites) with inhalation exposure: 48 Basis:

INHALATION MONITORING DATA REVIEW 1) Uncertainty (estimate based on model, regulatory limit or data not specific to industry): Yes 2)a) Exposure level > 1 mg/day? Yes OR b) Hazard Rating for health of 2 or greater? 1 No Inhalation Monitoring Data Desired? Yes (both criteria met) Dermal: Exposure to Liquid at 100.00% concentration High End: 1.8E+3 mg/day over 250 days/yr Number of workers (all sites) with dermal exposure: 48 Basis:

Exposure to Solid at 26.00% concentration High End: 8.1E+2 mg/day over 250 days/yr Number of workers (all sites) with dermal exposure: 48 Basis:

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0160
Use: Number of Sites/ Location: 1 Berry Plastics Corporation Calhoun GA 30701 Days/yr: 250 Basis:file:///J|/INITENG/P11%20cases/p110160eng.txt[3/2/2012 8:23:18 AM] Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources to the same medium. Water or Air or Incineration or Landfill Output 2: 9.1E+0 kg/site-day over 250 days/yr from 1 site

Water or Incineration or Landfill Output 2: 1.8E+1 kg/site-day over 250 days/yr from 1 site

Water or Incineration or Landfill Output 2: 1.8E+1 kg/site-day over 250 days/yr from 1 site

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 48 Basis:file:///J|/INITENG/P11%20cases/p110160eng.txt[3/2/2012 8:23:18 AM] Inhalation: Exposure to Particulate (Class I) Upper Bound: 3.9E+1 mg/day over 250 days/yr Number of workers (all sites) with inhalation exposure: 48

INHALATION MONITORING DATA REVIEW 1) Uncertainty (estimate based on model, regulatory limit or data not specific to industry): Yes 2)a) Exposure level > 1 mg/day? Yes OR b) Hazard Rating for health of 2 or greater? 1 No Inhalation Monitoring Data Desired? Yes (both criteria met) Dermal: Exposure to Solid at 26.00% concentration High End: 8.1E+2 mg/day over 250 days/yr Number of workers (all sites) with dermal exposure: 48file:///J|/INITENG/P11%20cases/p110160eng.txt[3/2/2012 8:23:18 AM]

## A-003 Post Focus Exposure Report for PMN P-11-16010/5/2011 Page 1 of 9

POST FOCUS EXPOSURE REPORT Chemical ID: P-11-0160 Reviewer: Kwon/SD

Results Table: Dose, Concentration, and Days Exceeded Results Summary

Exposure Scenario 1 Water Landfill Stack Air Fugitive Air
Drinking Water Fish Ingestion ADR LADD ADR LADD 7Q10 4 CC = 3 PDM Days Exceede d LADD ADR LADD ADR LADD

Release activity(ies) 2 ; exposure calculation(s) 3 mg/kg/day mg/kg/day mg/kg/day mg/kg/day μg/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

Proc: max acute eco --- --- --- --- 5.41E+01 --- --- --- --- --- ---

Proc: PDM1 --- --- --- --- 5.41E+01 --- --- --- --- --- Proc: PDM2 --- --- --- --- 1.80E-02 --- --- --- --- ---
1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manufact uring (Mfg), Processing (Proc) and Use release activity labels. Multiple release activities are combined in one exposu re scenario if their releases occur at same location. 3 Exposure calculations are Acute Dose Rate (ADR), Lifetime Average Daily Dose (LADD), and Probabilistic Dilution Model (PDM). There may be one, two, or all th ree exposure calculations per exposure scenario. CC is the aquatic concentration of concern. 4 This column displays concentration values for the 7Q10 streamflow, which is defined as the average daily streamflow of the seven consecutive days of lowest flow within a ten year period. Remarks: Results Table: Exposure Based (X B)/Persistent (P2B2) Criteria

Parameter Exp Based Persistent Exceedance Value Drinking (Surface) Wate r Dose (mg/kg/day) No NA Fish Ingestion Dose (mg/kg/day) No NA Inhalation Dose (mg/kg/day) No NA Groundwater Dose (mg/kg/day) No NA Surface Water Release After Treatment (kg/yr) NA Total Release After Treatment (kg/yr) NA Consumer Use? Fate test recommendations?: (default is NA)10/5/2011 Page 2 of 9

POST FOCUS EXPOSURE REPORT

Chemical ID: P-11-0160 Assessor: Kwon/SD ENVIRONMENTAL RELEASES Scenario#:1 Number of Release Sites: Release Activity: Proc: Max ADR Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases:

Non-sludge/Sludge Release Days/yr: Per Site Release: (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:10/5/2011 Page 3 of 9

POST FOCUS EXPOSURE REPORT
Chemical ID: P-11-0160
SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY:Proc: Max ADR SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 59.20

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10 ALL 50 288.00 123.84 78.18 66.05 1.46 3.39 5.37 6.36 ALL 10 39.60 13.29 7.76 7.57 10.61 31.61 54.14 55.50

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10% Cancer LADD pot 6.79E-06 4.94E-05 mg/kg/day 1.72E-06 1.25E-05 mg/kg/day LADC pot 3.48E-04 2.53E-03 mg/L 2.06E-02 0.15 mg/kg Acute ADR pot 2.83E-04 2.64E-03 mg/kg/day 1.55E-04 1.13E-03 mg/kg/day

SIC Code Comments:10/5/2011 Page 4 of 9

POST FOCUS EXPOSURE REPORT

Chemical ID: P-11-0160 Assessor: Kwon/SD ENVIRONMENTAL RELEASES Scenario#:2 Number of Release Sites: Release Activity: Proc: PDM1 Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: Per Site Release: (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:10/5/2011 Page 5 of 9

POST FOCUS EXPOSURE REPORT
Chemical ID: P-11-0160
SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES SCENARIO #: 2 Number of Site s: RELEASE ACTIVITY:Proc: PDM1 SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 59.20

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10 ALL 50 288.00 123.84 78.18 66.05 1.46 3.39 5.37 6.36 ALL 10 39.60 13.29 7.76 7.57 10.61 31.61 54.14 55.50

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10% Cancer LADD pot 6.79E-06 4.94E-05 mg/kg/day 1.72E-06 1.25E-05 mg/kg/day LADC pot 3.48E-04 2.53E-03 mg/L 2.06E-02 0.15 mg/kg Acute ADR pot 2.83E-04 2.64E-03 mg/kg/day 1.55E-04 1.13E-03 mg/kg/day

SIC Code Comments:10/5/2011 Page 6 of 9

POST FOCUS EXPOSURE REPORT
Chemical ID: P-11-0160

SIC CODE EXPOSURES TO SURFACE WATER RELEASES SCENARIO #: 2 RELEASE ACTIVITY: Proc: PDM1 SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) ASSOCIATED SIC CODES: Subset of 4952 SIC CODE RESULTS

COC ( μ g/L) Percent of Year COC Exceeded Number of Days COC Exceeded Release days/year Loading (kg/site/day) Waste Water Treatment (%) High/Avg Analysis

3.00 High

Note:10/5/2011 Page 7 of 9

POST FOCUS EXPOSURE REPORT

Chemical ID: P-11-0160 Assessor: Kwon/SD ENVIRONMENTAL RELEASES Scenario#:3 Number of Release Sites: Release Activity: Proc: PDM2 Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: Per Site Release: (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:10/5/2011 Page 8 of 9

POST FOCUS EXPOSURE REPORT
Chemical ID: P-11-0160
SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES SCENARIO #: 3 Number of Site s: RELEASE ACTIVITY:Proc: PDM2 SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 59.20

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10 ALL 50 288.00 123.84 78.18 66.05 4.86E-04 1.13E-03 1.79E-03 2.12E-03 ALL 10 39.60 13.29 7.76 7.57 3.54E-03 1.05E-02 1.80E-02 1.85E-02

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10% Cancer LADD pot 3.79E-09 2.76E-08 mg/kg/day 9.62E-10 7.00E-09 mg/kg/day LADC pot 1.94E-07 1.41E-06 mg/L 1.15E-05 8.37E-05 mg/kg Acute ADR pot 9.45E-08 8.80E-07 mg/kg/day 5.17E-08 3.76E-07 mg/kg/day

SIC Code Comments:10/5/2011 Page 9 of 9

POST FOCUS EXPOSURE REPORT
Chemical ID: P-11-0160

SIC CODE EXPOSURES TO SURFACE WATER RELEASES SCENARIO #: 3 RELEASE ACTIVITY: Proc: PDM2 SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) ASSOCIATED SIC CODES: Subset of 4952 SIC CODE RESULTS

COC ( μ g/L) Percent of Year COC Exceeded Number of Days COC Exceeded Release days/year Loading (kg/site/day) Waste Water Treatment (%) High/Avg Analysis

3.00 High

## A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-11-160UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF POLLUTION PREVENTION AND TOXICS
REGULATION OF A NEW CHEMICAL SUBSTANCE
PENDING DEVELOPMENT OF INFORMATION

In the matter of: ) Premanufacture Notice Number:

) ) ) ) ) [ ] ) P-11-0160 ) ) ) ) )

_________________________________________________________________ Consent Order and Determinations Supporting Consent Order

_________________________________________________________________ii
TABLE OF CONTENTS

Preamble
I. Introduction II. Summary of Terms of the Order III. Contents of PMN IV. EPA's Assessment of Risk V. EPA's Conclusions of Law VI. Information Required to Ev aluate Environmental Effects

Consent Order
I. Scope of Applicability and Exemptions II. Terms of Manufacture, Impor t, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation of Information III. Recordkeeping IV. Successor Liability Upon Transfer of Consent Order V. Modification and Revocation of Consent Order VI. Effect of Consent Order

Attachment A - Definitions Attachment B - Notice of Transfer of Consent Orderiii 

## PREAMBLE

I. INTRODUCTION Under the authority of § 5(e) of the Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e)), the Environmental Protection Agency ("EP A" or "the Agency") issues the attached Order, regarding premanufacture notice (" PMN") P-11-0160 for the chemical substance [ (“the PMN substance”) submitted by [ ("the Company"), to take effectupon expiration of the PMN review period. The Company submitted the PMN to EPA pursuant to § 5(a)(1) of TSCA and 40 CFR Part 720. Under § 15 of TSCA, it is unlawful for any person to fail or refuse to comply with any provision of § 5 or any order issu ed under § 5. Violators may be subject to various penalties and to both criminal and civil liabil ity pursuant to § 16, and to specific enforcement and seizure pursuant to § 17. In addition, chemical substanc es subject to an Order issued under § 5 of TSCA, such as this one, are subject to the § 12(b) export notice requirement.

II. SUMMARY OF TERMS OF THE ORDER The Consent Order for this PMN substance requires the Company to: (a) submit to EPA certain toxicity testing at least 14 weeks before manu facturing or importing a total of [ ] of the PMN substance and (b) not use the PMN substance for anything other than as [ ].iv III. CONTENTS OF PMN By signing this Order, the Compa ny represents that it has carefu lly reviewed this document and agrees that all information here in that is claimed as confiden tial by the Company is correctly identified within brackets and that any informa tion that is not bracket ed is not claimed as confidential. To make this document availabl e for public viewing, EPA will remove only the information contained within the brackets.

Confidential Business Information Claims (Bracketed in the Preamble and Order) : submitter, chemical identity, production volume, use, pro cessing and use operations information, MSDS, and test data Chemical Identity: Specific: [ ] Generic: acetylated fatty acid glycerides
Use: Specific: [ Generic: open, non-di spersive (resin) Maximum 12-Month Production Volume : [ ] Test Data Submitted with PMN : health effects, environmental effects, physical/chemical properties

IV. EPA'S ASSESSMENT OF RISK The following are EPA's predictions regardi ng the probable toxicity and environmental releases of the PMN substance, based on the in formation currently available to the Agency.v

Environmental Effects Summary : ECOSAR predicts a chronic COC of 3 μg/L (ppb) based on estimated fish toxicity. An acute COC may be derived from the predicted algae LC50 of 0.26 mg/L by dividing this value by the default acute to chronic ratio of 4, yielding 0.065 mg/L or 65 μg/L (ppb). Predictions are based on SARs for esters; log Kow = 5.27; MW 358; pH 7; effective concentrations based on 100% active ingredients and mean measured concen trations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L. See www.epa.gov/opptintr/newchems/pubs/chemcat.htm

Environmental Release Summary :

Process Number of Sites Release to Water (kg/day) 0.2

Surface Water Concentration (ppb) 26 Days Exceeding Concern Level 14

V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis of the Consent Order: (a) EPA is unable to determine the potential fo r chronic aquatic toxicity from environmental release of the PMN substance. EPA therefore co ncludes, pursuant to § 5(e)(1)(A)(i) of TSCA,vi that the information available to the Agency is insufficient to permit a reasoned evaluation of the environmental effects of the PMN substance. (b) In light of the potential risk of chronic aquatic toxi city posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TS CA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable ri sk of injury to the environment. (c) In light of the estimat ed production volume and environmental release of the PMN substance, EPA has further concluded, pursuant to § 5(e)(1)(A)(ii)(II) of TSCA, that the PMN substance will be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities.

VI. INFORMATION REQUIRED TO EVALUATE ENVIRONMENTAL EFFECTS Triggered Testing. The Order prohibits the Company from exceeding a specified production volume unless the Company submits the information described in the Testing section of this Order in accordance with the cond itions specified in the Testing section.

## CONSENT ORDER

(a) Scope . The requirements of this Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal of th e chemical substance [ ] (P-11-0160)(“the PMN substa nce”) in the United States by [

(“the Company”), except to the ex tent that those activi ties are exempted by paragraph (b).

(b) Exemptions . Manufacturing, processing, distribution in commerce, use and disposal of the PMN substance is exempt from the requirements of this Order (except the requirements in the Recordkeeping and Successor Liability Upon Transf er Of Consent Order sections) only to the extent that (1) these activities are conducted in full compliance with all applicable requirements of the following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required in the Reco rdkeeping section of this Order.- 2 -

(1) Completely Reacted (Cured) . The requirements of this Or der do not apply to quantities of the PMN substance after they have been comple tely reacted (cured) or entrained in a film. (2) De Minimis Concentrations . The requirements of this Order do not apply to quantities of the PMN substance that are (1) present in the work area only as a mixture and (2) at a concentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or volume if the PMN substance is identified as a potential carc inogen). This exemption is not available if the Company has reason to believe that , during intended activities, the PMN substance in the mixture may be reconcentrated above the 1.0 or 0.1 percent le vel, whichever applies. If this Order contains New Chemical Exposure Limits provisions or Re lease to Water provisions that, respectively, specify a NCEL concentration (“TWA”) or in-stream concentration (“N”) less than the de minimis concentration specified here, then this de mini mis exemption does not apply to those provisions. (3) Export . Until the Company begins commercial manufacture of the PMN substance for use in the United States, the requirements of this Order do not apply to ma nufacture, processing or distribution in commerce of the PMN substance solely for export in accordance with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to manufacture the PMN substance for use in the United States, no further activity by the Company involving the PMN substance is ex empt as “solely for export” even if some amount of the PMN substance is later exported. At th at point, the requirements of this Order apply to all activities associated with the PMN substance while in the te rritory of the United States. Prior to leaving U.S. territory, even those quanti ties or batches of the PMN substa nce that are destined for export- 3 - are subject to terms of the Order, and count towa rds any production volume test triggers in the Testing section of this Order. (4) Research & Development (“R&D”) . The requirements of this Order do not apply to manufacturing, processing, distribu tion in commerce, use and disposal of the PMN substance in small quantities solely for rese arch and development in accord ance with TSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CFR 720.36. The requirements of this Order also do not apply to manufacturing, processing, distribu tion in commerce, use and disposal of the PMN substance when manufactured solely for non-commercial rese arch and development per 40 CFR 720.30(i) and TSCA §5(i). (5) Byproducts . The requirements of this Order do not apply to the PMN substance when it is produced, without separate commercial inte nt, only as a “byproduct” as defined at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). (6) No Separate Commercial Purpose . The requirements of this Order do not apply to the PMN substance when it is manufactured, pursuant to any of the exemptions in 40 CFR 720.30(h), with no commercial purpose separate from the substa nce, mixture, or article of which it is a part. (7) Imported Articles . The requirements of this Order do not apply to the PMN substance when it is imported as part of an “article” as defined at 40 CF R 720.3(c) and in compliance with 40 CFR 720.22(b)(1).

(c) Automatic Sunset . If the Company has obtained for the PMN substance a Test Market Exemption (“TME”) under TSCA §5(h)(1) and 40 CFR 720.38 or a Low Volume Exemption (“LVE”) or Low Release and Exposure Exemp tion (“LoREX”) under TSCA §5(h)(4) and 40 CFR- 4 - 723.50(c)(1) and (2) respectively, any such exempti on is automatically re ndered null and void as of the effective date of this Consent Order.

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION

PROHIBITION The Company is prohibited from manufacturi ng the PMN substance in the United States, for any nonexempt commercial purpose, pending th e development of information necessary for a reasoned evaluation of the chroni c aquatic environmental effect s of the substance, and the completion of EPA's review of, and regulatory action based on, that information, except in accordance with the conditions described in this Order.

TESTING (a) Section 8(e) Reporting. Reports of information on th e PMN substance which reasonably supports the conclusion that the PMN substance presents a substantial risk of injury to health or the environment and which is required to be reporte d under TSCA section 8(e) shall reference the appropriate PMN identification number for this substance and contain a statement that the substance is subject to this Cons ent Order. Additional information regarding section 8(e) reporting requirements can be found at www.epa.gov/oppt/tsca8e

.

(b) Notice of Study Scheduling. The Company shall notify, in writing, the Monitoring Assistance and Media Programs Division (2227A), Office of Enforcement and Compliance Assurance, U.S.- 5 - Environmental Protection Agency, 1200 Pennsylva nia Avenue, N.W., Washington, D.C. 20460, of the following information within 10 days of scheduling any study required to be performed pursuant to this Order, or within 15 days after the effective date of this Order, whichever is later: (1) The date when the study is scheduled to commence; (2) The name and address of the la boratory which will conduct the study; (3) The name and telephone number of a pers on at the Company or the laboratory whom EPA may contact regarding the study; and, (4) The appropriate PMN identification numbe r for each substance and a statement that the substance is subject to this Consent Order.

(c) Good Laboratory Practice St andards and Test Protocols. Each study required to be performed pursuant to this Order must be conducted accord ing to TSCA Good Laborat ory Practice Standards at 40 CFR Part 792 and using me thodologies generally accepted in the relevant scientific community at the time the study is initiated. Before starting to conduc t any such study, the Company should obtain guida nce from EPA on the adequacy of th e test protocols to address the outstanding safety issues by submitting written protocols to EPA. EPA will respond to the Company within 4 weeks of receiving the written pr otocols. Published test guidelines specified in paragraph (d) provide general guid ance for development of test prot ocols, but are not themselvesacceptable protocols. EPA guidance regarding the adequacy of a test protocol does not mean preacceptance of test results.- 6 - (d) Triggered Testing Requirements. The Company is prohibited from manufacturing or importing the PMN substance beyond the followi ng aggregate manufacture and import volumes ("the production limits"), unless the Compa ny conducts the following studies on the PMN substance and submits all final reports and underl ying data in accordance with the conditions specified in this Testing section.

Production Limit Study Guideline Daphnid chronic toxicity test OPPTS Test Guideline (Flow through conditions/ 850.1300 measured concentrations) Fish early-life stage toxicity test OPPTS Test Guideline (Flow through conditions/ 850.1400 measured concentrations) The special considerations for conducting A quatic Laboratory Studies (OPPTS 850.1000) should be used.

(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in a scientifically valid manner; (2) promptly furnis h to EPA the results of any interim phase of each study; and (3) submit, in triplic ate (with an additional sanitize d copy, if confidential business information is involved), the final report of each study and all underlying data ("the report and data") to EPA no later than 14 weeks prior to ex ceeding the applicable pr oduction limit. The final report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting," "Data a nd Reporting," and "Test Report" subparagraphs in the appli cable test guidelines. However, for purposes of this Consent Order, the word "should" in those subparagraphs shall be inte rpreted to mean "shall" to make clear that the submission of such information is mandatory. EPA will require the submission of raw data such as- 7 - slides and laboratory notebooks onl y if EPA finds, on the basis of professional judgment, that an adequate evaluation of the study cannot take place in the abse nce of these items.

(f) Testing Waivers. The Company is not required to conduc t a study specified in paragraph (d) of this Testing section if notifie d in writing by EPA that it is unnecessary to conduct that study.

(g) Equivocal Data. If EPA finds that the data generate d by a study are scientifically equivocal, the Company may continue to manufacture and import the PMN substance beyond the applicable production limit. To seek relief from any other re strictions of this Orde r, the Company may make a second attempt to obtain unequivocal data by reconducting the study under the conditions specified in paragraphs (b), (c), and (e)(1) and (2). The testing requirements may be modified, as necessary to permit a reasoned evaluation of th e risks presented by the PMN substance, only by mutual consent of EPA and the Company.

(h) EPA Determination of Invalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 weeks of EP A's receipt of a test report and data, the Company receiv es written notice that EPA finds that the data generated by a study are scientifically invalid, the Company is prohibited from further manufacture and import of the PMN substance beyond the applicable production limit. (2) The Company may conti nue to manufacture and import the PMN substance beyond the applicable production limit only if so notified, in writing, by EPA in response to the Company's compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii).- 8 - (i) The Company may rec onduct the study in compliance wi th paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3) . If there is insufficient time for the Company to comply with subparagraph (e)(3), the Co mpany may exceed the production limit and shall submit the report and data in triplicate to EPA with in a reasonable period of time, all as specified by EPA in the notice described in subparagraph (h)(1). EPA will respond to the Company, in writing, within 6 weeks of receivi ng the Company's report and data. (ii) The Company may, within 4 weeks of receiving from EPA the notice described in subparagraph (h)(1), submit to EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 w eeks of receiving the Company's report.

(i) Company Determination of Invalid Data. (1) Except as described in subparagraph (i)(2), if the Company becomes aware that circumstances clearly beyond the control of the Company or laboratory will prevent, or have prevented, development of scientif ically valid data under the conditi ons specified in paragraphs (c) and (e), the Company remains prohibited from further manufacture and import of the PMN substance beyond the appli cable production limit. (2) The Company may submit to EPA, within 2 weeks of first becoming aware of such circumstances, a written statement explaining w hy circumstances clearly beyond the control of the Company or laboratory will cause or have caused de velopment of scientifically invalid data. EPA- 9 - will notify the Company of its response, in writ ing, within 4 weeks of receiving the Company's report. EPA's written response may either: (i) allow the Company to continue to manufacture and import the PMN substance beyond the applicable production limit, or (ii) require the Company to continue to conduct, or to rec onduct, the study in compliance with paragraphs (b), (c), and (e)(1) a nd (2). If there is sufficient time to conduct or reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). If there is insufficien t time for the Company to comply with subparagraph (e)(3), the Company may exceed the production limit and shall s ubmit the report and data in triplicate to EPA within a reasonable period of time, all as specifi ed by EPA in the notice de scribed in subparagraph (i)(2). EPA will respond to the Company, in wr iting, within 6 weeks of receiving the Company's report and data, as to whether the Company may continue to manufacture and import beyond the applicable production limit.

(j) Unreasonable Risk. (1) EPA may notify the Company in writing th at EPA finds that the data generated by a study are scientifically valid and un equivocal and indicate that, despite the terms of this Order, the PMN substance will or may present an unreasonable risk of injury to human health or the environment. EPA's notice may specify that th e Company undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal of the PMN substance to mitigate exposures to or to be tter characterize the risks presented by the PMN- 10 - substance. Within 2 weeks from receipt of such a notice, the Company must cease all manufacture, import, processing, distribution, us e and disposal of the PMN substance, unless either: (2) within 2 weeks from receipt of the notice described in su bparagraph (j)(1), the Company complies with such requireme nts as EPA's notice specifies; or (3) within 4 weeks from receipt of the notice described in su bparagraph (j)(1), the Company submits to EPA a written report refuting EP A's finding and/or the appropriateness of any additional requirements imposed by EPA. The Co mpany may continue to manufacture, import, process, distribute, use and dispose of the PMN substance in accordance w ith the terms of this Order pending EPA's response to the Company's written report. EPA will respond to the Company, in writing, within 4 weeks of receiving the Company's report. Within 2 weeks of receipt of EPA's written response, the Company shall comply with any requirements imposed by EPA's response or cease all manufacture, import, processing, distribution, us e and disposal of the PMN substance.

(k) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing section, the Company must continue to obey all the terms of this Consent Order until otherwise notified in writing by EPA. The Company may, based upon submitted test data or other relevant information, petition EPA to modify or revoke provi sions of this Consent Order pursuant to Part VI. of this Consent Order.

USE- 11 - (a) The Company shall not use th e PMN substance other than as ].

DISTRIBUTION (a) Export Notice Requirement . No later than the date of dist ribution, the Compa ny shall notify in writing any person to whom it dist ributes the PMN substance that, due to the issuance of this Consent Order under section 5(e) of TSCA, the PMN substance is subject to the export notification requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in the form in which it appears in this Consent Order, the following information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN substance, or (B) if the specific chemical identity is confiden tial, the generic chemical identity.

(b) Distribution Requirements. (i) Except after the PMN has been completely reacted (or entrained in a film), or as provided in paragr aph (c), the Company shall distribute the PMN substance outside the Company, other than for dispos al, only to a person who has agreed in writing prior to the date of distribution, to: (1) Notify in writing any person to whom it di stributes the PMN substance that, due to the issuance of this Consent Order under section 5(e) of TSCA, the PMN substance is subject to the export notification requirements of TSCA section 12(b) and 40 CF R Part 707 Subpart D. Such notice shall contain, in the form in which it appears in this Consent Order, the following information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN substance, or (B) if the specific chemical identity is confidential, the generic chemical identity.- 12 - (2) Not further distribute the PMN substance to any other person, other than for disposal, until after the PMN substance has been completely reacted (cured) or entrained in a film. (3) Not use the PMN substance other than as described in the PMN, as [

. (ii) Disposal Exemption . Except for the §12(b) export notice requirement in paragraph (b)(i)(1) above, the distribution requirements in (b)(i) do not apply when the Company distributes the PMN substance for disposal only.

(c) Temporary Transport and Storage. Notwithstanding paragra ph (b), the Company may distribute the PMN substance outside the Company for temporary transport and storage in sealed containers provided the follo wing two conditions are met: (1) Subsequent to any such exempt temporary transport or storage of sealed containers, the PMN substance may be distributed only to the Company or a person who has given the Company the written agreement re quired by paragraph (b). (2) Any human exposure or environmental release resulting from opening the sealed containers and removing or washing out the PMN substance may occur only while the PMN substance is in the possession and control of th e Company or a person who has given the Company the written agreement re quired by paragraph (b).

(d) Recipient Non-Compliance. If, at any time after commenci ng distribution in commerce of the PMN substance, the Company obtains knowledge that a recipient of the substance has failed to comply with any of the conditions specified in pa ragraph (b) of this Dist ribution section or, after- 13 - paragraph (b)(2) expires in accordance with subpara graph (e)(1), has engaged in a significant new use of the PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a significant new use notice to EPA, the Compa ny shall cease supplying the substance to that recipient, unless the Company is able to document each of the following: (1) That the Company has, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any of the conditions specified in paragraph (b) of this Distribution section, or has e ngaged in a significant new use of the PMN substance without submitting a significant new use notice to EPA. (2) That, within 15 working days of notif ying the recipient of the noncompliance, the Company received from the recipient, in writing, a statement of assurance that the recipient is aware of the terms of paragraph (b) of this Distribution section and will comply with those terms, or is aware of the terms of the significant new use rule for the PMN substance and will not engage in a significant new use without submitti ng a significant new use notice to EPA. (3) If, after receiving a stat ement of assurance from a r ecipient under subparagraph (d)(2) of this Distribution section, the Company obtains know ledge that the recipient has failed to comply with any of the conditions specified in paragraph (b) of this Distri bution section, or has engaged in a significant new use of the PMN substance without submitting a significant new use notice to EPA, the Company shall cease supplying the PMN subs tance to that recipien t, shall notify EPA of the failure to comply, and sha ll resume supplying the PMN substa nce to that recipient only upon written notification from the Agency.- 14 - (e) Sunset Following SNUR. (1) Paragraph (b)(2) of this Distribution secti on shall expire 75 days after promulgation of a fi nal SNUR for the PMN substance under section 5(a)(2) of TSCA, unless the Company is notified on or before that day of an action in a Federal Court seeking judicial review of the SNUR. If the Company is so notified, paragraph (b )(2) of this Distribution section shall not expire until EPA notifies the Co mpany in writing that all Federal Court actions involving the SNUR have been resolved and the validity of the SNUR affirmed. (2) When EPA promulgates a final SNUR for th e PMN substance and paragraph (b)(2) of this Distribution section expires in a ccordance with subparagraph (e)(1), the Company shall notify each person to whom it distributes the PMN substance of the existence of the SNUR. Such notification must be in writing and must speci fically include all limitations contained in the SNUR which are defined as significant new uses, and which would invoke significant new use notification to EPA for the PMN substance. Such notice must also reference the publication of the SNUR for this PMN substance in either the Federal Register or the Code of Federal Regulations. After promulgation of a SNUR and expiration of subpara graph (b)(2), such notice may substitute for the written agreement required in the introductory clau se of paragraph (b); so that, if the Company provides such notice to the persons to whom it di stributes the PMN substance, then the Company is not required to obtain from such persons the written agreement specified in paragraph (b).

III. RECORDKEEPING (a) Records. The Company shall maintain the followi ng records until 5 years after the date they are created and shall make them available for inspection and copying by EPA in accordance with section 11 of TSCA:- 15 - (1) Exemptions . Records documenting that the PMN s ubstance did in fact qualify for any one or more of the exemptions described in Secti on I, Paragraph (b) of this Order. Such records must satisfy all the statutory and regulatory recordkeeping re quirements applicable to the exemption being claimed by the Company. Any amounts or batches of the PMN substance eligible for the Export exemption in Section I, Paragraph (b)(3) of this Order are exempt from all the requirements in this Recor dkeeping section, if the Company ma intains, for 5 years from the date of their creation, copies of the export label and expor t notice to EPA, required by TSCA sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches of the PMN substance eligible for the Research and Development exempti on in Section I, Paragra ph (b)(4) of this Order are exempt from all the requirements in this Reco rdkeeping section, if the Company maintains, for 5 years from the date of their creation, th e records required by 40 CFR 720.78(b). For any amounts or batches of the PMN substance claimed to be eligible for any other exemption described in Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating qualification for that exemption as well as the reco rds specified in paragra phs (2) and (3) below, but is exempt from the other recordkeeping re quirements in this Recordkeeping section; (2) Records documenting the manufacture a nd importation volume of the PMN substance and the corresponding dates of manufacture and import; (3) Records documenting the names and addresses (including shipment destination address, if different) of all pers ons outside the site of manufacture or import to whom the Company directly sells or transfers the PM N substance, the date of each sale or transfer, and the quantity of the substance sold or tr ansferred on such date;- 16 - (4) Records documenting the address of all sites of manufacture, import, processing, and

use; (5) Records documenting compliance with a ny applicable use restrictions in the Use section of this Order; (6) Copies of any Transfer Documents and notices required by the Successor Liability section of this Order, if applicable; and, (7) The Company shall keep a copy of this Order at each of its sites where the PMN substance is manufactured or imported.

(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities of the Company and its Contract Manufacturer, if applicable, and not to activities of the Company's customers.

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this “collection of information” unless this Order displays a cu rrently valid control number from the Office of Management and Budget (“OMB”), and EPA so informs the Company. The “collection of information” required in this TSCA §5(e) Consent Order has been approved under currently valid OMB Control Number 2070-0012.

IV. REQUESTS FOR PRE-IN SPECTION INFORMATION- 17 - (a) EPA’s Request for Information . Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA may occasionally conduct on-site compliance inspec tions of Company facilities and conveyances associated with the PMN substance. To facilit ate such inspections, EPA personnel may contact the Company in advance to request information pertinent to the scheduling and conduct of such inspections. Such requests may be written or oral . The types of information that EPA may request include, but are not limited to, the following: (i) Expected dates and times when the PM N substance will be in production within the subsequent 12 months; (ii) Current workshift schedules for workers who are involved in activities associated with the PMN substance and may reasonably be exposed to the PMN substance; (iii) Current job titles or categories for work ers who are involved in activities associated with the PMN substance and may reasonabl y be exposed to the PMN substance; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substance and may r easonably be exposed to the PMN substance; (v) Records required by the Recordkeep ing section of this Order; and/or (vi) Any other information reasonably related to determining compliance with this Order or conducting an inspection for that purpose.

(b) Company’s Response . The Company shall respond to such requests within a reasonable period of time, but in no event later than 30 days after receiving EPA’s request. When requested in writing by EPA, the Company’s response shall be in writing. To the extent the information is known to or reasonably ascertainable to the Comp any at the time of the request, the Company’s- 18 - response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers to all of EPA’s requests.

(c) Confidential Business Information . Any Confidential Business In formation (“CBI”) that the Company submits to EPA pursuant to paragraph (b ) shall be protected in accordance with §14 of TSCA and 40 CFR Part 2.

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by which the Co mpany's rights and obligations under this Order may be transferred when the Company transfers its interests in the PMN substance, including the right to manufacture the PMN substance, to another person outside the Company (the "Successor in Interest").

(b) Relation of Transfer Date to Notice of Commencement ("NOC"). (1) Before NOC. If the transfer from the Company to the Successor in Interest is effective before EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a new PMN to EPA and comply fully with Section 5(a)(1) of TSCA and 40 CFR part 720 before commencing manufacture or import of the PMN substance. (2) After NOC. If the transfer from the Company to the Successor in Interest is effective after EPA receives a NOC, the Successo r in Interest shall comply with the terms of this Order and shall not be required to submit a new PMN to EPA.- 19 -

(c) Definitions. The following definitions apply to this Successor Liability sect ion of the Order: (1) "Successor in Interest" means a pe rson outside the Company who has acquired the Company's full interest in the rights to manufact ure the PMN substance, including all ownership rights and legal liabilities, thr ough a transfer document signed by the Company, as transferor, and the Successor in Interest, as transferee. The te rm excludes persons who acquire less than the full interest of the Company in the PMN substance, such as a licensee who has acquired a limited license to the patent or manuf acturing rights associated with th e PMN substance. A Successor in Interest must be incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(a)(3). (2) "Transfer Document" means the legal inst rument(s) used to conve y the interests in the PMN substance, including the right to manufacture the PMN substance, from the Company to the Successor in Interest.

(d) Notices. (1) Notice to Successor in Interest. On or before the effectiv e date of the transfer, the Company shall provide to the Successor in Intere st, by registered mail, a copy of the Consent Order and the "Notice of Transfer" document which is incorporated by reference as Attachment B to this Order. (2) Notice to EPA. Within 10 business days of the e ffective date of the transfer, the Company shall, by registered mail, submit the fu lly executed Notice of Transfer document to:- 20 - U.S. Environmental Protection Agency, Ne w Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies of the Transfer Docu ment must be maintained by the Successor in Interest at its principal place of busin ess, and at all sites where the PMN substance is manufactured or imported. Copies of the Transf er Document must also be made available for inspection pursuant to Section 11 of TSCA, must state the effectiv e date of transfer, and must contain provisions which expressly transfer liabi lity for the PMN substance under the terms of this Order from the Company to the Successor in Interest.

(e) Liability. (1) The Company shall be liable for complian ce with the requirements of this Order until the effective date of the transfer described above. (2) The Successor in Interest shall be liabl e for compliance with the requirements of this Order effective as of the date of transfer. (3) Nothing in this section shall be c onstrued to prohibit the Agency from taking enforcement action against the Company after the eff ective date of the transf er for actions taken, or omissions made, during the time in which the Comp any manufactured, processed, used, distributed in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order.

(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing section of this Consent Order requires th e Company to submit test data to EPA at a specified production volume ("test trigger"), the a ggregate volume of the PMN substance manufactured and imported- 21 - by the Company up to the date of transfer shall c ount towards the test tri gger applicable to the Successor in Interest.

VI. MODIFICATION AND REVO CATION OF CONSENT ORDER The Company may petition EPA at any time, based upon new information on the environmental effects or environmental release of the PMN substance, to modify or revoke substantive provisions of this Order. The exposur es and risks identified by EPA during its review of the PMN substance and the information EPA de termined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend or revoke this Order, EPA will consider al l relevant information available at the time the Agency makes that determination, including, where appropriate, any reassessm ent of the test data or other information that supports the findings in this Order, an ex amination of new test data or other information or analysis, a nd any other relevant information. EPA will issue a modification or revocation if EPA determines that the activities proposed therein will not present an unreasonable risk of injury to health or the environment and will not result in significant or substantial human expos ure or substantial environmental release in the absence of data sufficient to permit a reasoned eval uation of the health or environmental effects of the PMN substance. In addition, the Company may petition EPA at a ny time to make other modifications to the language of this Order. EPA will issue such a modification if EPA determines that the modification is useful, appropriate, and consistent with the structur e and intent of this Order as issued.ATTACHMENT A DEFINITIONS

Note: The attached Order may not cont ain some of the terms defined below. “Chemical name” means the sc ientific designation of a chem ical substance in accordance with the nomenclature system developed by the Chemical Abstracts Service’s rules of nomenclature, or a name which will clearly iden tify a chemical substance for the purpose of conducting a hazard evaluation. “Chemical protective clothing” means items of clothing that provide a protective barrier to prevent dermal contact with chemical substances of concern. Examples can include, but are not limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. “Company” means the person or persons subject to this Order. “Commercial use” means the use of a chemi cal substance or any mixture containing the chemical substance in a commercial enterprise pr oviding saleable goods or a service to consumers (e.g., a commercial dry cleaning estab lishment or painting contractor). “Common name” means any designation or identi fication such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other than by its chemical name. “Consumer” means a private individual who uses a chemical substance or any product containing the chemical substance in or around a permanent or temporary household or residence, during recreation, or for any personal use or enjoyment. “Consumer product” means a chemical substance th at is directly, or as part of a mixture, sold or made available to consumers for thei r use in or around a permanent or temporary household or residence, in or around a school, or in recreation. “Container” means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical . For purposes of this section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. “Contract Manufacturer” means a person, out side the Company, who is authorized to manufacture and import the PMN substance under th e conditions specified in Part II. of this Consent Order and in the Consent Order for Contract Manufacturer. “Identity” means any chemical or common name used to identify a chem ical substance or a mixture containing that substance.2 “Immediate use.” A chemical substance is for the “immediate use” of a person if it is under the control of, and used only by, the person who tr ansferred it from a labeled container and will only be used by that person within the work shift in which it is transferred from the labeled container. “Impervious.” Chemical protective clothing is “impervious” to a chemical substance if the substance causes no chemical or mechanical degradation, permeation, or penetration of the chemical protective clothing under the condi tions of, and the duration of, exposure. “Manufacturing stream” means all reasonably an ticipated transfer, flow, or disposal of a chemical substance, regardless of physical stat e or concentration, throug h all intended operations of manufacture, including the cleaning of equipment. “MSDS” means material safety data sheet, the written listing of data for the chemical substance. “NIOSH” means the National In stitute for Occupational Safety and Health of the U.S. Department of Health and Human Services. “Non-enclosed process” means any equipment sy stem (such as an open-top reactor, storage tank, or mixing vessel) in which a chemical subs tance is manufactured, processed, or otherwise used where significant direct contact of the bul k chemical substance and the workplace air may occur. “Non-industrial use” means use other than at a facility where chemical substances or mixtures are manufacture d, imported, or processed. “PMN substance” means the chemical substa nce described in the Premanufacture notice submitted by the Company relevant to this Order. “Personal protective equipment” means any ch emical protective clothi ng or device placed on the body to prevent contact wi th, and exposure to, an identif ied chemical substance or substances in the work area. Examples incl ude, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types of respirators. Barrier creams are not included in this definition. “Process stream” means all reasonably anticipate d transfer, flow, or disposal of a chemical substance, regardless of physical state or con centration, through all in tended operations of processing, including the cleaning of equipment. “Scientifically invalid” means any significan t departure from the EPA-approved protocol or the Good Laboratory Practice Sta ndards at 40 CFR Part 792 without prior or subsequent Agency approval that prevents a reasoned evaluation of the health or e nvironmental effects of the PMN substance.3

“Scientifically equivocal data” means da ta which, although deve loped in apparent conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsis tent, or otherwise insufficient to permit a reasoned evaluation of the potential risk of injury to human health or the environment of the PMN substance. “Sealed container” means a closed container th at is physically and chemically suitable for long-term containment of the PMN substance, and from which there will be no human exposure to, nor environmental release of, the PMN s ubstance during transport and storage. “Use stream” means all reasonabl y anticipated transfer, flow, or disposal of a chemical substance, regardless of physical state or con centration, through all in tended operations of industrial, commercial , or consumer use. “Waters of the United States” has the meaning set forth in 40 CFR 122.2. “Work area” means a room or defined space in a workplace where the PMN substance is manufactured, processed, or used and where employees are present. “Workplace” means an establishment at one geographic location cont aining one or more work areas.ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER

___________________________ _________________ Company (Transferor) PMN Number

1. Transfer of Manufacture Rights. Effective on _______________, the Company did sell or otherwise transfer to ________________________________, (“Successor in Interest”) the rights and liabilities associated with manufacture of th e above-referenced chemical substance, which was the subject of a premanufacture notice (“PMN”) a nd is governed by a Consent Order issued by the U.S. Environmental Protection Agency (“EPA”) under the authority of §5(e) of the Toxic Substances Control Act (“TS CA,” 15 U.S.C. §2604(e)).

2. Assumption of Liability. The Successor in Interest hereby certi fies that, as of the effective date of transfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, di stribution in commerce and disposal of the PMN substance, shall be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in th e United States in accordance with 40 CFR 720.22(a)(3).

3. Confidential Business Information. The Successor in Interest hereby:
___ reasserts, ___ relinquishes, or ___ modifies all Confidential Business Information (“CBI”) cl aims made by the Company, pursuant to Section 14 of TSCA and 40 CFR part 2, for the PMN substanc e(s). Where “reasserts” or “relinquishes” is indicated, that designation shall be deemed to apply to all such claims. Where “modifies” is indicated, such modification shall be explained in detail in an attachment to this Notice of Transfer. Information which has been previously disclosed to the public (e.g., a chemical identity that was not claimed as CBI by the original su bmitter) would not subsequently be eligible for confidential treatment under this Notice of Transfer.2

TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER NOTICE OF TRANSFER (continued)

___________________________________ _____________________ Company (Transferor) PMN Number

___________________________________ _____________________ Signature of Authori zed Official Date

___________________________________ Printed Name of Authorized Official

___________________________________ Title of Authorized Official

___________________________________ Successor in Interest

___________________________________ _____________________ Signature of Authori zed Official Date

___________________________________ Printed Name of Aut horized Official

___________________________________ Title of Authorized Official

___________________________________ Address

___________________________________ City, State, Zip Code3

TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER NOTICE OF TRANSFER (continued)

___________________________________ Successor’s Technical Contact

___________________________________ Address

___________________________________ City, State, Zip Code

___________________________________ Phone