# Project XL Site-Specific Rulemaking for the Ortho-McNeil Pharmaceutical, Inc. Facility in Spring House, PA Involving On-Site Treatment of Mixed Wastes
> **Rule** · Final rule. · Published 2005-06-27 · Effective 2005-06-27 · 70 FR 36850
## Document
- **Document number:** 05-12658
- **Category:** hazardous-waste
- **Federal Register citation:** 70 FR 36850
- **CFR reference:** 40 CFR 261
- **Publication date:** 2005-06-27
- **Effective date:** 2005-06-27
- **EPA docket:** RCRA-2001-0021
## Abstract

The Environmental Protection Agency (EPA) is today finalizing this rule to implement a pilot project under the Project XL program, providing site-specific regulatory flexibility under the Resource Conservation and Recovery Act (RCRA), as amended, for the Ortho-McNeil Pharmaceutical, Inc. facility in Spring House, Pennsylvania (OMP Spring House). The principal objective of this XL project is to obtain information helpful to determining whether regulatory oversight by the Nuclear Regulatory Commission (NRC), or NRC Agreement States, under authority of the Atomic Energy Act (AEA) is sufficient to ensure protection of human health and the environment regarding the management of certain small volumes of mixed wastes (i.e., RCRA hazardous wastes that also contain radioactive materials) that are both generated and treated in an NRC-licensed pharmaceutical research and development laboratory. If, as a result of this XL project, the Agency determines that certain small volumes of low-level mixed wastes (LLMW) generated and managed under NRC oversight need not also be subject to RCRA hazardous waste regulations to ensure protection of human health and the environment, EPA may consider adopting the approach on a national basis.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/06/27/05-12658/project-xl-site-specific-rulemaking-for-the-ortho-mcneil-pharmaceutical-inc-facility-in-spring-house)
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