6 CCR 1007-3-8.84 - 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.

The Colorado Solid and Hazardous Waste Commission, after a public hearing on November 18, 2014, voted to tentatively approve the petition to delist F006 hazardous waste generated by electroplating operations (anodizing and chemical etching) at the Depuy Synthes Facility located at 1051 Synthes Avenue in Monument, Colorado 80132. The Commission's tentative decision is subject to public written comment until January 26, 2015. If no adverse comments are received, the tentative decision will become the final decision, and the delisting will become effective on March 2, 2015 without further notice. If the Commission receives adverse comments, the Commission will publish a timely withdrawal in the Colorado Register informing the public that the rule will not take effect.

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.

Statement of Basis and Purpose Rulemaking Hearing of May 19, 2015


6 CCR 1007-3-8.84
37 CR 24, December 25, 2014, effective 3/2/2015 38 CR 11, June 10, 2015, effective 6/30/2015 39 CR 05, March 10, 2016, effective 3/30/2016 39 CR 11, June 10, 2016, effective 6/30/2016 40 CR 06, March 25, 2017, effective 4/14/2017 40 CR 11, June 10, 2017, effective 6/30/2017 40 CR 21, November 10, 2017, effective 11/30/2017 41 CR 06, March 25, 2018, effective 4/14/2018 41 CR 11, June 10, 2018, effective 6/30/2018 41 CR 24, December 25, 2018, effective 1/14/2019 42 CR 06, March 25, 2019, effective 4/14/2019 42 CR 06, March 25, 2019, effective 5/30/2019 42 CR 11, June 10, 2019, effective 6/30/2019 43 CR 12, June 25, 2020, effective 7/15/2020 44 CR 06, March 25, 2021, effective 4/14/2021 44 CR 11, June 10, 2021, effective 6/30/2021 44 CR 24, December 25, 2021, effective 1/14/2022 45 CR 11, June 10, 2022, effective 6/30/2022 45 CR 17, September 10, 2022, effective 9/10/2022 45 CR 17, September 10, 2022, effective 9/30/2022 45 CR 23, December 10, 2022, effective 1/30/2023

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