DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

Solid and Hazardous Waste Commission/Hazardous Materials and Waste Management Division

6 CCR 1007-3

hazardous waste

Proposed Depuy Synthes F006 Delisting

1) Appendix IX of Part 261 is amended by adding Delisting #009 to read as follows:

PART 261, APPENDIX IX – WASTES EXCLUDED UNDER §§ 260.20 AND 260.22 

******* 

DELISTING #:	009

FACILITY:		Depuy Synthes

ADDRESS:		1051 Synthes Avenue, Monument, Colorado  80132

WASTE:	Wastewater treatment sludge from the on-site treatment of wastewater generated from electroplating operations (anodizing and chemical etching).  EPA hazardous waste code F006 generated after the effective date of this delisting.

CONDITIONS:	This delisting is valid only for the waste stream specified above and referenced in the delisting petition submitted on August 4, 2014 and under the following conditions:

a.	Changes to Current Operations

1.	Depuy Synthes must notify the Hazardous Materials and Waste Management Division (the Division) at least 30-days prior to implementing any major change to the electroplating processes at the Facility.  A major change is any change including alteration of the current wastewater treatment process or incorporating different chemicals or reagents into the process such that the composition of the wastewater treatment sludge is altered.  

2.	Depuy Synthes must notify the Division within 15-days after implementing any change to the wastewater treatment or electroplating processes that causes a significant change in the type or concentration of any hazardous constituent in the waste or causes the waste to exhibit a hazardous waste characteristic.  A significant change is defined as an increase in the total waste concentration for any constituent identified below:

Constituent
	
Average Concentration (ppm)	
2xs the Standard Deviation	
Concentration Requiring Notification to the Division (Two Standard Deviations above the Average Concentration)
	
Arsenic	Non-detect	Non-detect	Detection	
Barium	19.0	42.8	61.8	
 Cadmium	Non-detect	Non-detect	Detection	
Chromium (Total)	6,170	13,585.4	19,755.4	
Chromium VI	0.035	0.08	0.12	
Copper	525.5	1,157.8	1,683.3	
Cyanide (amendable)	Non-detect	Non-detect	Detection	
Cyanide (free/reactive)	0.005	0.0002	0.0052	
Lead	870.4	2,139.0	3,009.4	
Mercury	0.11	0.04	0.15	
Nickel 	2,197	4,958.6	7,155.6	
Selenium	Non-detect	Non-detect	Detection	
Silver	1.53	3.44	4.97	

A significant change also includes the detection of any additional Part 264, Appendix IX hazardous constituents that are not identified in the above table.

3.	The Division reserves the right to re-evaluate and, if necessary, remove this approval or modify these conditions in the event that a significant change, as defined above, is reported by Depuy Synthes.  In such case, the Division may remove this delisting or impose temporary requirements on the delisted waste until such time as an appropriate amendment to this delisting can be considered by the Solid and Hazardous Waste Commission.  

b.	Sampling Requirements

Depuy Synthes shall conduct annual verification sampling of the delisted waste in January of each year to monitor for any significant change in the type or concentration of any hazardous constituents in the delisted waste.  Annual verification sampling shall be submitted to the Division within sixty (60) days of the sampling event for review against initial criteria and sampling methodology.  

c.	Storage Requirements

1.	The delisted waste generated by Depuy Synthes may not be accumulated on-site for a period in excess of one year.

2.	The volume of delisted waste accumulated on-site may not exceed 20 cubic yards at any given time.

3.	The delisted waste must be stored in a container that is capable of being closed.  The container must be marked or labeled to identify the contents as “delisted waste” and with an accumulation start date.  The container must be kept closed except for when waste is being added to or removed from the container.  

d.	Recordkeeping Requirements

1.	Depuy Synthes shall maintain records of the disposal or recycling of all delisted waste that documents that such activities are in accordance with the delisting petition.

2.	Depuy Synthes shall maintain all records required by paragraph d.i above for a period of at least three years.

e.	Disposal Requirements

The delisted waste shall be disposed in a landfill meeting the requirements of the Colorado Solid Waste Regulations (6 CCR 1007-2) or recycled at an appropriate metals reclamation facility.  

2) Section 8.84 {Statement of Basis and Purpose for the Rulemaking Hearing of November 18, 2014} is added to Part 8 of the Regulations to read as follows:
Statement of Basis and Purpose
Rulemaking Hearing of November 18, 2014

8.84	Basis and Purpose

This amendment to 6 CCR 1007-3, Part 261, Appendix IX is made pursuant to the authority granted to the Solid and Hazardous Waste Commission in § 25-15-302(2), C.R.S.

Amendment of Part 261, Appendix IX to Conditionally Delist F006 Hazardous Waste Generated by Depuy Synthes located at 1051 Synthes Avenue in Monument, Colorado  80132.

Appendix IX of Part 261 is being amended to conditionally delist F006 hazardous waste generated at Depuy Synthes in Monument, Colorado.  This delisting will allow Depuy Synthes to dispose of this waste at a solid waste landfill meeting the requirements of the Colorado Solid Waste Regulations (6 CCR 1007-2) or a metals recycling facility provided it complies with the conditions of the delisting.  The Solid and Hazardous Waste Commission (the “Commission”) is requiring an annual verification sampling of the delisted waste and the results of that verification sampling must be submitted to the Division within sixty (60) days of the sampling event for review against initial delisting criteria and sampling methodology.  

Depuy Synthes operates a manufacturing facility in Monument, Colorado for the production of surgical quality screws, plates and nails for medical use.  After manufacturing, a finish is applied to the metal parts in one or more metal finishing operations including electro-polishing (chemical etching), anodizing, or chemical conversion coating (passivation).  Rinse water from these metal finishing operations is treated on-site in a wastewater treatment unit to remove heavy metals prior to discharging the treated wastewater to the publicly owned treatment works (POTW).  The process of treating the wastewater generates wastewater treatment sludge.  Pursuant to the listing description at § 261.31, wastewater treatment sludge generated from electroplating operations is classified as F006 hazardous waste.  

The basis for the F006 hazardous waste listing is described in Appendix VII of Part 261 of the hazardous waste regulations.  Each listing is based on hazardous constituents that are typically contained in the waste described by the listing.  The hazardous constituents that formed the basis for the F006 listing include cadmium, hexavalent chromium (Chromium VI), nickel and complexed cyanide.  

Samples of the wastewater treatment sludge generated at Depuy Synthes were collected and submitted for analysis prior to submittal of the delisting petition.  Four discrete samples of the wastewater treatment sludge were collected in accordance with a sampling and analysis plan that was reviewed and approved by the Hazardous Materials and Waste Management Division at the Colorado Department of Public Health and Environment.  

Analytical results of the wastewater treatment sludge indicate that the sludge does not exhibit any of the hazardous waste characteristics.  Sample results confirmed that the sludge does not contain organic toxicity characteristic constituents above detection levels.  In addition, the sludge does not exhibit the toxicity characteristic for the eight heavy metals.  The waste also does not exhibit the hazardous waste characteristic of corrosivity, ignitability or reactivity.

Copper and nickel were also analyzed using the toxicity characteristic leaching procedure (TCLP).  The results of that analysis indicate that these two constituents were present in the leachate well below the EPA Residential Soil Screening Levels.  

Analytical results of the wastewater treatment sludge indicate that the petitioned sludge contains hazardous constituents that are a basis for listing a waste as a F006 hazardous waste.  These constituents include nickel, chromium VI and cyanide.  Based on the chemical analysis of the waste samples, the average total concentration for these constituents is as follows:  2,197 parts per million (ppm) nickel, 0.005 ppm cyanide and 0.035 ppm chromium VI.  With the exception of nickel, these average total constituent constituents are below the EPA Residential and Industrial Soil Screening Levels.  The total average concentration of nickel is below the EPA Industrial Soil Screening Level.  

Other constituents detected in the waste samples include barium, copper, lead, mercury and silver.  The average total concentration for these constituents is: 19.0 ppm barium, 525.5 ppm copper, 870.4 ppm lead, 0.11 ppm mercury and 1.53 ppm silver.  The average total concentration for these constituents is below the EPA Residential Soil Screening Level with the exception of lead.  The average total concentration for lead is 70.4 ppm above the EPA Industrial Soil Screening Level of 800 ppm.  However, as a condition of this delisting, all waste will be disposed in a solid waste landfill or recycled at an appropriate metals reclamation facility.  

Using the average total concentrations of the constituents in the waste, health risk calculations were determined for residential exposure to the waste.  The risk calculations were determined using the EPA’s Regional Screening Level Calculator, which utilizes current health based toxicity data obtained from EPA’s Integrated Risk Information System (IRIS) and Health Effects Assessment Summary Tables (HEAST).  The calculator was used to determine the risk associated with the waste for a residential soil exposure scenario that evaluated the carcinogenic and non-carcinogenic risk through ingestion, dermal and inhalation pathways.

A total carcinogenic risk of greater than 1 x 10-6 of one added cancer death per million exposed individually represents an unacceptable risk to human health, according to EPA risk assessment guidance.  The calculated carcinogenic risk for the wastewater treatment sludge is 1.42 x 10-7.  Therefore, this waste does not pose a carcinogenic risk.  

The risk assessment calculations for the non-carcinogenic risk or cumulative total hazard quotient posed by the concentrations of detected metals in the waste were calculated at a level of 1.75.  This level exceeds the hazard quotient index (HI) of 1 for the residential soil exposure scenario due to the presence of nickel.  However, when nickel is excluded from the calculation the HI is reduced to 0.21.  As a condition of this delisting, the wastewater treatment sludge will be disposed in a solid waste landfill or at a metals recycling facility.  

This delisting is being granted under conditions specifying disposal, record keeping, storage and sampling requirements for the delisted sludge.  Conditional delisting of the waste also prohibits any major changes to the metal finishing operations or wastewater treatment process without prior notification, evaluation, and approval by the Division.  

This delisting does not apply to waste that demonstrates a  “significant change” as defined in Delisting #009 in Part 261, Appendix IX—Wastes Excluded Under § 260.20 and 260.22(d), or if any of the conditions specified in Part 261, Appendix IX for this delisting are not met.  Should either of these occur, the waste is and must be managed as a hazardous waste.  While the Commission is approving this conditional delisting for this specific waste at this specific site, the findings and criteria associated with the approval are unique.  Other petitions for delisting, even if similar in material or use, will be reviewed by the Division on a case-by-case basis.