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EXCLUSIONS FROM REGULATION AS HAZARDOUS WASTEOne presentation in a series that briefly explains the Federal exclusions from full regulation for certain materials under the Resource Conservation and Recovery Act (RCRA).

This presentation: 40 CFR 261.4(b)(17):OMP Spring House Exclusion

40 CFR 261.4(b)(17)

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PRESENTED BY:

Daniels Training Services815.821.1550www.DanielsTraining.comInfo@DanielsTraining.com

A different kind of training.

40 CFR 261.4(b)(17)

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40 CFR 261.4(b)

• Paragraph ‘b’ of section 261.4 identifies 18 solid wastes excluded from regulation as a hazardous waste.

Solid Waste

Hazardous Waste

40 CFR 261.4(b)(17)

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What is Excluded at 40 CFR 261.4(b)?

1) Household waste

2) Agricultural waste

3) Mining overburden

4) Fossil fuel combustion waste

5) Oil, gas, & geothermal wastes

6) Trivalent chromium wastes

7) Mining & mineral-

processing wastes

8) Cement kiln dust

9) Arsenically-treated wood

10) Petroleum-contaminated media & debris from underground storage tanks

40 CFR 261.4(b)(17)

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What is Excluded at 40 CFR 261.4(b)?

11) Hydrocarbon recovery operations

12) Spent chlorofluorocarbon refrigerants

13) Used oil filters

14) Used oil distillation bottoms

15) Leachate or gas condensate from

landfills carrying the K169 - K172 listings

16) Reserved

17) OMP Spring House exclusions

18) Disposable wipes w/o trichloroethylene

40 CFR 261.4(b)(17)

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OMP Spring House Exclusion

Nothing available

2011 RCRA Orientation Manual

40 CFR 261.4(b)(17)

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“The following solid wastes are not hazardous wastes for the purpose of this part…”

• Low-level mixed wastes (LLMW), if:• Generated at the Ortho-McNeil Pharmaceutical, Inc. (OMP Spring House) R&D facility in Spring House, PA

And…• Treated on-site using a bench-scale high temperature catalytic oxidation unit.

If…• Total volume of LLMW generated & treated is ≤50 L/yr.

40 CFR 261.4(b)(17)

More…

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“The following solid wastes are not hazardous wastes for the purpose of this part…”

• OMP Spring House must submit a written report to the EPA Region III every 6 months beginning December 27, 2005; must include:

1. Analysis demonstrating the destruction & removal efficiency of the treatment technology for all organic components of the wastestream.

2. Analysis demonstrating the capture efficiencies of the treatment technology for all radioactive components of the wastestream & an estimate of the amount of radioactivity released during the reporting period.

40 CFR 261.4(b)(17)

More…

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“The following solid wastes are not hazardous wastes for the purpose of this part…”

3. Analysis (including concentrations of constituents, including inorganic constituents, present & radioactivity) of the wastestream prior to & after treatment.

4. Volume of the wastestream being treated per batch, as well as a total for the duration of the reporting period.

5. Final disposition of the radioactive residuals from the treatment of the wastestream.

40 CFR 261.4(b)(17)

And…

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“The following solid wastes are not hazardous wastes for the purpose of this part…”

• OMP Spring House makes no significant changes to the design or operation of the high temperature catalytic oxidation unit or the wastestream.

• This exclusion will remain in affect for 5 years from June 27, 2005.

40 CFR 261.4(b)(17)

Conditional exclusion expired 6.27.10

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More to Consider (1)…

• Project XL Pilot Project Program provides site-specific conditional exclusions from hazardous waste; as in this situation.

• Low level mixed waste (LLMW) as defined at 40 CFR 266.210:• Low-Level Mixed Waste (LLMW) is a waste that contains both low-level radioactive waste and RCRA hazardous waste.

40 CFR 261.4(b)(17)

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40 CFR 261.4(b)(17) Verbatim (1):

(b)Solid wastes which are not hazardous wastes. The following solid wastes are not hazardous wastes:

…

(17) Solid waste that would otherwise meet the definition of low-level mixed wastes (LLMW) pursuant to §266.210 of this chapter that is generated at the Ortho-McNeil Pharmaceutical, Inc. (OMP Spring House) research and development facility in Spring House, Pennsylvania and treated on-site using a bench-scale high temperature catalytic oxidation unit is not a hazardous waste provided that:

40 CFR 261.4(b)(17)

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40 CFR 261.4(b)(17) Verbatim (2):(b)Solid wastes which are not hazardous wastes. The following solid wastes are not hazardous wastes:

…

(17) (i) The total volume of LLMW generated and treated is no greater than 50 liters/year, (ii) OMP Spring House submits a written report to the EPA Region III office once every six months beginning six months after June 27, 2005, that must contain the following:

(A) Analysis demonstrating the destruction and removal efficiency of the treatment technology for all organic components of the wastestream,

(B) Analysis demonstrating the capture efficiencies of the treatment technology for all radioactive components of the wastestream and an estimate of the amount of radioactivity released during the reporting period,

40 CFR 261.4(b)(17)

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40 CFR 261.4(b)(17) Verbatim (3):

(b)Solid wastes which are not hazardous wastes. The following solid wastes are not hazardous wastes:

…

(17)(ii)(C) Analysis (including concentrations of constituents, including inorganic constituents, present and radioactivity) of the wastestream prior to and after treatment,

(D) Volume of the wastestream being treated per batch, as well as a total for the duration of the reporting period, and

40 CFR 261.4(b)(17)

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40 CFR 261.4(b)(17) Verbatim (4):

(b)Solid wastes which are not hazardous wastes. The following solid wastes are not hazardous wastes:

…

(17)(ii)(E) Final disposition of the radioactive residuals from the treatment of the wastestream.

(iii) OMP Spring House makes no significant changes to the design or operation of the high temperature catalytic oxidation unit or the wastestream.

(iv) This exclusion will remain in affect for 5 years from June 27, 2005.

40 CFR 261.4(b)(17)

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40 CFR 261.4(b)(17)