Project XL Site-Specific Rulemaking for the Ortho-McNeil Pharmaceutical, Inc. Facility in Spring House, PA Involving On-Site Treatment of Mixed Wastes, 36850-36858 [05-12658]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 122 (Monday, June 27, 2005)]
[Rules and Regulations]
[Pages 36850-36858]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12658]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 261

[RCRA-2001-0021; FRL-7928-8]
RIN 2090-AA14


Project XL Site-Specific Rulemaking for the Ortho-McNeil 
Pharmaceutical, Inc. Facility in Spring House, PA Involving On-Site 
Treatment of Mixed Wastes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: 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.

DATES: Effective Date: This final rule is effective on June 27, 2005.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. RCRA-2001-0021. All documents in the docket are listed in the 
EDOCKET index at https://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically in 
EDOCKET or in hard copy at the RCRA Docket, EPA/DC, EPA West, Room 
B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading 
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Public Reading 
Room is (202) 566-1744, and the telephone number for the RCRA Docket is 
(202) 566-0270.

FOR FURTHER INFORMATION CONTACT: Mr. Charles Howland, U.S. 
Environmental Protection Agency, Region III (3OR00), 1650 Arch Street, 
Philadelphia, PA, 19103-2029. Mr. Howland can be reached at (215) 814-
2645 (or howland.charles@epa.gov).

SUPPLEMENTARY INFORMATION:

Outline of Today's Rule

    The information presented in this preamble is organized as follows:

I. Authority
II. Overview of Project XL
III. Overview of the OMP Spring House XL Pilot Project
    A. To Which Facilities Does the Final Rule Apply?
    B. What Problems Does the OMP Spring House XL Project Attempt To 
Address?
    1. Current Regulatory Status of Mixed Wastes
    2. Site-Specific Considerations at the OMP Spring House Facility
    C. What Solution Is Being Tested by the OMP Spring House XL 
Project?
    D. What Regulatory Changes Are Being Made to Implement this 
Project?
    E. Why is EPA Promulgating This Approach To Removing RCRA 
Regulatory Controls Over a Mixed Waste?
    F. How Have Various Stakeholders Been Involved in this Project?
    G. Response to Major Comments Received on the Proposed Rule
    H. How Will This Project Result in Cost Savings and Paperwork 
Reduction?
    I. What Are the Terms of the OMP Spring House XL Project and How 
Will They Be Enforced?
    J. How Long Will This Project Last and When Will It Be 
Completed?
IV. RCRA & Hazardous and Solid Waste Amendments of 1984
    A. Applicability of Rules in Authorized States
    B. Effect on Pennsylvania Authorization
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act of 1995
    J. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations
    K. Executive Order 12988: Civil Justice Reform
    L. Congressional Review Act

I. Authority

    EPA is publishing this regulation under the authority of sections 
2002, 3001, 3002, 3003, 3006, 3007, 3010, 3013, and 7004 of the Solid 
Waste Disposal Act of 1970, as amended by the Resource Conservation and 
Recovery Act, as amended (42 U.S.C. 6912, 6921, 6922, 6923, 6926, 6927, 
6930, 6934, and 6974).

II. Overview of Project XL

    The Final Project Agreement (FPA) sets forth the intentions of EPA, 
Pennsylvania Department of Environmental Protection (PADEP), and the 
OMP Spring House facility with regard to a project developed under 
Project XL, an EPA initiative that allows regulated entities to achieve 
better environmental results with additional regulatory flexibility. 
This final regulation, along with the FPA (contained in the docket for 
this rule under Docket ID No. RCRA-2001-0021), will facilitate 
implementation of the project. Project XL --``eXcellence and 
Leadership''-- was announced on March 16, 1995, as a central part of 
the Agency's effort to reinvent environmental protection. See 60 FR 
27282 (May 23, 1995). Project XL provides a limited number of private 
and public regulated entities an opportunity to develop their own pilot 
projects to request regulatory flexibility that will result in 
environmental protection that is superior to what would be achieved 
through compliance with current and reasonably-anticipated future 
regulations. For more information about the XL Program in general, and 
XL project criteria and project development processes in detail, 
readers should refer to https://www.epa.gov/projectxl/. Additional 
background information on the proposed OMP Spring House Project XL 
site-specific rulemaking published is available at https://www.epa.gov/
projectxl/ortho/index.htm and published in the Federal

[[Page 36851]]

Register, specifically: July 24, 2001 (66 FR 38396), two descriptive 
documents published in the Federal Register (60 FR 27282, May 23, 1995 
and 62 FR 19872, April 23, 1997), and the December 1, 1995 ``Principles 
for Development of Project XL Final Project Agreements'' document. For 
further discussion as to how the OMP Spring House XL project addresses 
the XL criteria, readers should refer to the Final Project Agreement 
available from the EPA RCRA docket (Docket ID No. RCRA-2001-0021; see 
ADDRESSES section of today's preamble).

III. Overview of the OMP Spring House XL Pilot Project

    Today's final rule will facilitate implementation of the FPA that 
has been developed by EPA, PADEP, the OMP Spring House facility, and 
other stakeholders. Today's final rule will become effective under 
Pennsylvania State law in accordance with the Commonwealth's hazardous 
waste program, as described further in section IV of this preamble.
    To implement this XL project, today's final rule provides a site-
specific exemption from the regulatory definition of hazardous waste 
for the mixed wastes generated and treated in OMP's Spring House 
research and development laboratory. The terms of the overall XL 
project are contained in an FPA which is included in the docket for 
today's final rule. A draft version of the FPA was the subject of a 
Notice of Availability published in the Federal Register on September 
1, 2000 in which EPA solicited comment. The FPA was signed on September 
22, 2000 by representatives of EPA, the Pennsylvania Department of 
Environmental Protection (PADEP), and Ortho-McNeil Pharmaceutical. The 
exemption from the regulatory definition of hazardous waste of the 
mixed wastes generated at the OMP Spring House facility will remain in 
effect only for the five-year term of this XL project, and begins upon 
the effective date of this final rule.

A. To Which Facilities Does the Final Rule Apply?

    This final rule will apply only to the OMP Spring House facility. 
Thus, mixed wastes generated in other pharmaceutical research and 
development facilities remain subject to current Resource Conservation 
and Recovery Act (RCRA) Subtitle C regulations. (The Agency notes that 
the term ``RCRA Subtitle C regulations'' includes the exemptions and 
exclusions specific to mixed wastes that have been promulgated as part 
of the regulatory program.) Further, the regulatory modification will 
only affect the mixed waste that is the focus of this XL project; 
hazardous wastes resulting from any other operations at the OMP Spring 
House facility are not affected by today's final rule.

B. What Problems Will the OMP Spring House XL Project Attempt To 
Address?

    The OMP Spring House facility does not believe the RCRA Subtitle C 
regulatory controls, as applied to the low-level mixed wastes (LLMW) it 
generates and treats, provide any additional environmental protection 
than is otherwise provided by the Atomic Energy Act (AEA) oversight, 
and indeed believes that RCRA Subtitle C regulatory controls serve as a 
major disincentive to environmentally protective on-site treatment of 
the small volume of mixed wastes generated at the facility.
    While limited commercial off-site treatment for such wastes is 
available, the on-site, bench-scale, high-temperature catalytic 
oxidation unit OMP Spring House will use to treat the mixed wastes has 
been demonstrated to be more efficient in preventing the emission of 
radioactivity to the atmosphere and at least as efficient, if not more, 
at destroying the organic components than available commercial 
treatment. (The on-site treatment of OMP Spring House's mixed wastes 
has been tested under a ``treatability study'' exemption provided in 40 
CFR 261.4(f), and granted by PADEP.) According to OMP Spring House, it 
has not sought a RCRA hazardous waste treatment permit for the 
catalytic oxidation unit because the costs of permitting cannot be 
justified from a business standpoint for the small volume of LLMW 
generated. Nor does OMP Spring House intend to become a commercial 
mixed waste treatment facility, receiving mixed wastes from off-site 
facilities which might enable it to recover the costs of a RCRA permit. 
Finally, OMP Spring House has asserted (as have many of those who 
commented on EPA's July, 2001 proposed rule) that the costs of existing 
off-site commercial treatment for the small volume of mixed wastes 
typically generated in the pharmaceutical research industry are very 
high and therefore hinder the research and development of new 
pharmaceuticals.
1. Current Regulatory Status of Mixed Wastes
    Mixed waste comprises radioactive hazardous waste, subject to two 
statutory authorities: (1) The RCRA as implemented by EPA (or States 
authorized by EPA) with jurisdiction over the hazardous waste 
component; and (2) the AEA as implemented by either the Department of 
Energy (DOE), or the Nuclear Regulatory Commission (NRC) (or its 
Agreement States) with jurisdiction over the radioactive component of 
the waste. Therefore, absent today's regulatory modification, the 
management of the mixed wastes that are the subject of this XL pilot 
project would continue to be subject to both RCRA permitting and NRC 
licensing requirements and regulatory oversight from the point the 
waste is generated through to its final disposal.
    Members of the regulated community have raised concerns that this 
dual regulatory oversight of LLMW is unduly burdensome, duplicative and 
costly, without providing any additional protection of human health and 
the environment beyond that achieved under one regulatory regime. In 
response to these concerns, on April 30, 2001, EPA Administrator 
Christine Todd Whitman signed a final mixed waste rule modifying the 
existing regulatory framework to provide flexibility related to the 
storage, treatment (of certain types), transportation and disposal for 
LLMW (see 66 FR 27217, May 16, 2001). This rule became effective on 
November 13, 2001 (``Mixed Waste Rule'').
    In developing the Mixed Waste Rule, EPA assessed NRC regulations 
for storage, treatment, transportation and disposal of low-level wastes 
(LLW) and compared them with EPA's regulations for hazardous waste 
storage, treatment, transportation and disposal applicable to LLMW. The 
Agency found that given NRC's regulatory controls, protection of human 
health and the environment from chemical risks would not be compromised 
by deferral to NRC's LLW management requirements under the 
circumstances set forth in the Mixed Waste Rule. Accordingly, through 
the Mixed Waste Rule, the Agency adopted a conditional exemption from 
certain RCRA hazardous waste management requirements for NRC-licensed 
generators of LLMW, in specified circumstances.
    Basically, the Mixed Waste Rule allows generators of LLMW to claim 
a conditional exemption from the RCRA regulatory definition of 
hazardous waste for mixed wastes stored, treated, transported or 
disposed of under the NRC regulatory regime, acknowledging the 
protectiveness of NRC regulations for LLW (of which LLMW is a part). 
(For the complete text of the Mixed Waste Rule, see 66 FR 27217, May, 
16, 2001.) More specifically, the conditional exemption allows, among 
other things,

[[Page 36852]]

a generator to treat LLMW generated under a single NRC or NRC Agreement 
State license, in tanks or containers, without having to obtain a RCRA 
treatment permit, provided the form of treatment is allowed under its 
NRC or NRC Agreement State license. The conditional exemption for 
storage and treatment is only available to generators of LLMW that are 
licensed by the NRC or NRC Agreement States. In addition, the Mixed 
Waste Rule provides that LLMW that meets the applicable Land Disposal 
Restrictions (LDR) standards (either as generated or through treatment) 
may be transported and disposed of as LLW at an NRC or NRC Agreement 
State licensed low-level radioactive waste disposal facility (LLRWDF), 
which need not also possess a RCRA treatment, storage, or disposal 
permit.
2. Site-Specific Considerations at the OMP Spring House Facility
    OMP Spring House conducts research and development of 
pharmaceuticals/drugs at its Spring House, Pennsylvania facility. As 
part of this work, OMP Spring House develops and utilizes radiolabeled 
compounds to study the bioabsorption and metabolism of the drugs, in 
compliance with Food and Drug Administration (FDA) requirements. The 
radiolabeled compounds typically consist of an isotopically-labeled 
organic compound and a solvent (the specific solvent varies with the 
research being conducted). The solvent is mixed with a radioisotope 
(typically carbon-14 (\14\C) or tritium (\3\H)), yielding both the 
desired radiolabeled compound, and a waste mixture that consists of 
radioactive materials (over which NRC has jurisdiction) and a hazardous 
organic component (over which EPA has jurisdiction). This radioactive/
hazardous organic waste mixture is the LLMW that is the focus of this 
XL pilot project. The estimated volume of mixed waste produced per 
batch by OMP Spring House ranges from less than 50 milliliters to 
several liters, with an annual total volume of less than 50 liters.
    OMP Spring House has developed an innovative bench-scale treatment 
process (using high-temperature catalytic oxidization), which oxidizes 
the mixed waste, thereby destroying its hazardous waste components 
(yielding water and CO2 ) and capturing the radioactivity in 
the aqueous residuals or as radioactive CO2. In this process 
the liquid LLMW is completely reacted with oxygen or air at high 
temperature in the presence of an oxidation catalyst. [For a general 
physical description of the bench-scale high-temperature catalytic 
oxidizing unit and how it operates, the reader is referred to the July 
24, 2001 proposed rule (see 66 FR at 38399). For a more complete 
technical description of the unit, operations parameters and analytical 
methodology, the reader is referred to the document titled ``A 
Prototype High-Temperature Catalytic Oxidation Process For Mixed Waste 
In A Pharmaceutical Research Laboratory,'' available in the docket for 
today's final rule under Docket ID No. RCRA-2001-0021.]
    OMP Spring House's treatment of carbon-14 labeled compounds 
generates radioactive CO2 (which is subsequently converted 
to potassium carbonate) and the treatment of tritium labeled compounds 
generates radioactive (i.e., tritiated) water (\3\H). These residual 
low-level wastes could then be sent off-site for stabilization, 
recycling, or disposal under NRC or NRC Agreement State regulation. 
[The Agency notes that because the treatment process yields one of two 
residuals from a variety of LLMW, they are more amenable to recycling 
(e.g., recovery of tritium). However, recycling the small volumes of 
residuals being generated at the OMP Spring House facility is not 
currently economically viable. OMP Spring House has been working to 
support efforts to facilitate the recovery of radioactivity from 
residuals like those it generates in its high-temperature catalytic 
oxidization process.] For tritium containing compounds, the volume of 
the treatment residual is generally the same volume as the wastestream 
being treated. For carbon-14 containing compounds, the volume of the 
treatment residuals is generally slightly higher than the volume of the 
original wastestream being treated. The yearly estimated volume of the 
treatment residuals generated by the high-temperature catalytic 
oxidation of LLMW at OMP Spring House is 50 liters per year, which is 
about the same as the volume of the original LLMW.
    OMP Spring House has been operating this innovative catalytic 
oxidation process for the treatment of the mixed wastes it generates 
since 1996 under a ``treatability study exemption'' approved by the 
PADEP, which is authorized to carry out portions of the RCRA hazardous 
waste program in Pennsylvania. This treatability study has been 
conducted to evaluate the performance of the catalytic oxidation 
process on the organic component of these mixed wastes and the capture 
of the radioactive components.
    The treatment technology being employed by OMP Spring House is not 
included under the 2001 Mixed Waste Rule because it is not conducted 
within a ``tank'' or ``container,'' as those terms are defined in RCRA. 
The Agency determined that more specific controls (as are presently 
provided under RCRA) are generally more appropriate for certain forms 
of treatment, such as thermal treatment (including incineration) which 
take place outside of a ``tank'' or ``container,'' due to the 
complexity and variety of such processes and the specificity of RCRA 
requirements. This XL pilot project affords the Agency an opportunity 
to test whether a defined subset of LLMW (e.g., small volumes of 
research and development laboratory-generated mixed wastes being 
treated within the NRC-licensed laboratory in which the wastes are 
generated) may safely be treated outside of a tank or container (e.g., 
use of a bench-scale high temperature catalytic oxidation process) 
without RCRA regulatory controls (i.e., a treatment permit pursuant to 
Subtitle C of RCRA), instead relying on AEA regulations implemented by 
the NRC. Thus, this pilot project is intended to assess the 
appropriateness of the dual oversight (i.e., concurrent RCRA and AEA 
regulatory controls) exerted over the small volumes of mixed wastes 
generated and treated at this pharmaceutical research and development 
facility, and to characterize those factors that could inform EPA's 
decision whether mixed wastes generated and treated in similar 
circumstances should also be exempted from the regulatory definition of 
hazardous wastes (and thus, RCRA regulatory control) on a national 
basis (in effect, deferring regulatory oversight of these specific 
types of mixed wastes to NRC or NRC Agreement States). The pilot 
project will also provide the Agency additional data regarding the 
performance of the on-site, bench-scale high-temperature catalytic 
oxidation unit used to treat the mixed wastes, which will also be 
considered as part of any future determination regarding possible 
changes to the types of units included in RCRA's May 2001 Mixed Waste 
Rule.
    To date, OMP Spring House's treatability study has yielded 
extremely positive results, demonstrating that the full range of 
organics used to produce radiolabeled compounds are effectively 
eliminated (routinely achieving destruction and removal efficiencies 
(DRE) of 99.999% to 99.99999%) by the high-temperature catalytic 
oxidation process. The treatment process exceeds Land Disposal 
Restricitons (LDR) treatment standards for organics, and

[[Page 36853]]

releases only negligible amounts of radioactivity\1\1.
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    \1\ During calendar year 2003, air emissions monitoring revealed 
an annual average concentration of 7.54E-11 uCi/mL for tritium and 
2.09E-11 uCi/mL for carbon-14 for all operations (i.e., not just 
emissions from the high-temperature catalytic oxidation process). 
These annual average concentrations of radionuclides in effluent air 
are less than 0.08% of the limits specified by NRC in 10 CFR Part 20 
for allowable concentrations in effluent air (i.e., 1 x 10E-7 mCi/mL 
for tritium and 3 x 10E-7 uCi/mL for carbon-14 (present as carbon 
dioxide-\14\C)). Note that these units are expressed in microcuries 
(10 E-6 curies)/milliliter.
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    The catalytic oxidation unit is housed in a laboratory fume hood 
within OMP Spring House's radiosynthesis laboratory suite. All seven 
fume hoods in the lab suite are connected to a dedicated stack for air 
emissions. This air pollution control system employs high efficiency 
particulate arresting (HEPA) filtration to capture any fugitive dusts 
or particulate matter. No other pharmaceutical research operations, or 
other processes performed at the facility are tied into this system. 
Air emissions monitoring for radioactivity is performed whenever the 
process is operating. The monitoring is of the consolidated non-
turbulent air stream within the ventilation system after the juncture 
of the seven hoods and prior to emissions into the atmosphere via the 
dedicated stack.

C. What Solution Is Being Tested by the OMP Spring House XL Project?

    OMP Spring House originally proposed that EPA address its LLMW in 
one of three ways:

--Exempt the bench-scale treatment of mixed wastes from permitting 
requirements,
--Provide permit-by-rule exemptions for the bench-scale treatment of 
mixed wastes, or
--De-list post-oxidation wastes pursuant to 40 CFR 260.20 and 260.22 to 
allow the treatment of the LLMW.
    Under each of these alternatives, OMP Spring House noted that the 
laboratory in which the wastes are generated and treated would continue 
to be subject to an NRC license, which it believed would be sufficient 
to protect human health and the environment during the generation and 
treatment of its LLMW, especially considering the very small volumes of 
wastes being generated and treated, the small size of the treatment 
unit, the proximity of the treatment unit to the point of generation 
(the wastes are both generated and treated within the same laboratory 
room), the sophisticated level of expertise of the technicians that 
work in the lab, and the protective controls (e.g., emission limits) 
required by the NRC license.
    EPA and the PADEP agreed that applicability of OMP Spring House's 
NRC license conditions was likely sufficient to ensure that OMP Spring 
House's high-temperature catalytic oxidation would be operated so as to 
be protective of human health and the environment absent RCRA 
regulatory controls, and EPA determined that the most appropriate 
mechanism to confirm this was by exempting OMP Spring House's LLMW from 
RCRA's definition of hazardous waste, as discussed below.

D. What Regulatory Changes Are Being Made To Implement This Project?

    To allow for this XL project to be implemented, the Agency proposed 
on July 24, 2001 to provide a site-specific exemption in 40 CFR 
261.4(b) (i.e., ``Solid wastes which are not hazardous wastes'') for 
the mixed wastes generated and treated in OMP Spring House's 
pharmaceutical research and development (R&D) laboratory (see 66 FR 
38396). The Agency is today finalizing this site-specific rule, albeit 
clarifying that it comprises an exemption to RCRA's definition of 
hazardous waste, not an exclusion to RCRA's definition of solid 
waste.\2\ The effect of this exemption, assuming all the conditions are 
met, is to remove these wastes from RCRA Subtitle C regulation at the 
point of their generation. Further, because the residuals resulting 
from the catalytic oxidation treatment process will not be derived from 
hazardous wastes, no ``delisting'' is required for these residuals 
(since the original wastestream will no longer comprise a RCRA 
``listed'' waste). The Agency believes that this regulatory mechanism 
is the most efficient way to provide OMP Spring House with the 
regulatory outcome it seeks and implement the XL pilot project.
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    \2\ In its July, 2001 proposal, EPA characterized the regulatory 
flexibility to be offered under this XL Project as comprising a
    ``site specific exclusion in 40 CFR 261.4(b) (i.e. `Solid wastes 
which are not hazardous wastes') for the mixed wastes generated and 
treated in OMP Spring House's pharmaceutical research and 
development (R&D) laboratory. The effect of this exclusion, assuming 
all the conditions are met, will be to exclude these wastes from 
RCRA Subtitle C regulation at the point of generation, * * * Instead 
of being considered `mixed wastes,' these wastes will simply be 
considered low-level wastes (LLWs) subject to NRC or NRC Agreement 
State regulation.''
    66 FR at 38400-01.
    EPA has determined that its use of the word ``exclusion'' (which 
generally applies to materials excluded from RCRA's definition of 
solid waste under 40 CFR 261.4(a) rather than materials exempted 
from RCRA's definition of hazardous waste under 40 CFR 261.4(b)), 
and the potential implication that this regulatory change would 
result in clarification. In this final rule, EPA makes plain that 
the effect of this regulatory change is to conditionally exempt OMP 
Spring House's LLMW from RCRA's definition of hazardous waste under 
40 CFR 261.4(b) (and thus from its hazardous waste regulations). OMP 
Spring House's LLMW remains a solid waste under RCRA and thus, is 
subject to EPA's enforcement authority under Section 7001 of RCRA.
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    The site-specific exemption being finalized today is conditioned on 
various reporting requirements intended to provide the Agency with the 
data necessary to determine whether this XL pilot project is a success 
and obtain the information to help it decide whether the regulatory 
change should be ``transferred'' to the national program (which, if it 
occurs, would happen through normal rulemaking procedures). The 
specific conditions are further discussed in section III.I.

E. Why Is EPA Supporting This Approach To Removing RCRA Regulatory 
Controls Over a Mixed Waste?

    The Agency agrees with OMP Spring House that this XL project has 
merit and has the potential to result in significant environmental and 
efficiency benefits should the regulatory change be adopted on a 
national basis. While the Agency adopted the Mixed Waste Rule to 
generically address the regulation of some mixed wastes, Project XL 
offers the Agency the opportunity to test alternative approaches, in 
this case, an alternative approach tailored to a specific subset of the 
generic category of mixed wastes not covered by the Mixed Waste Rule. 
The Agency believes this is the type of ``test'' that Project XL is 
intended to facilitate. The information and data gathered throughout 
the course of this XL project will provide the Agency with the ability 
to make a more informed determination regarding the appropriate 
regulatory controls for ``mixed waste'' generally, as well as certain 
discrete subsets of ``mixed waste'' that may be amenable to an 
alternative regulatory approach.

F. How Have Various Stakeholders Been Involved in This Project?

    During the developmental stages of this XL pilot project, OMP 
Spring House cultivated stakeholder involvement from the local 
community and local environmental groups in a variety of ways. These 
methods included communicating through the local news media, 
announcements at Township meetings, public meetings and direct contact 
with interested parties. For a more detailed description of the methods 
used to involve stakeholders and the meetings held with the local 
community to discuss the pilot project, the reader is referred to the 
July 24, 2001 proposed rulemaking (see 66 FR at 38401).

[[Page 36854]]

    OMP Spring House understands that stakeholder involvement is an 
integral part of the XL process and will continue to hold public 
meetings with the local community to provide updates and information on 
this XL pilot project, as needed.

G. Response to Major Comments Received on the Proposed Rule

    The Agency received 65 comments in response to the July 24, 2001 
proposed rule. Detailed responses to all of these comments is presented 
in the document titled ``Response to Comments on the OMP Spring House 
XL Project NPRM'' contained in the docket for today's final rulemaking 
under Docket ID No. RCRA-2001-0021. The vast majority of these comments 
were very supportive and generally encouraged the Agency to move 
quickly to consider similar regulatory flexibility on a national scale. 
However, two commenters submitted adverse comments, and several 
commenters provided editorial suggestions and requests for 
clarification.
    The two commenters which opposed the proposed rule were both 
commercial LLMW treatment facilities, capable of treating OMP Spring 
House's's LLMW. (EPA does note that several other treatment facilities 
offered comments that were supportive of the proposal.) These two 
commenters questioned the merits of reducing regulatory oversight for 
such wastes (with the potential for increased risks); the impact of 
such an exemption on the existing commercial mixed waste treatment 
industry (which has invested substantial resources to obtain the 
necessary permits and licenses), and, (if the regulatory flexibility is 
adopted on a national scale for research and development laboratories) 
the advisability of having many facilities generating radioactive 
residuals (even if they are small in volume and recyclable) rather than 
a small number of commercial facilities generating such residuals 
(albeit in larger quantities).
    The Agency has considered the concerns expressed by these 
commenters; however, it believes this pilot project should go forward. 
The Agency believes that the NRC license provides sufficient 
protections, at least in this specific situation, such that a RCRA 
permit is not necessary. Thus, we disagree with the commenter who 
argues that the facility would be ``unlicensed/unpermitted.'' We also 
disagree with the commenter who suggested that this rulemaking would 
reduce the treatment standards for this waste. As has been 
demonstrated, the high-temperature catalytic oxidation unit utilized by 
OMP Spring House meets or exceeds the existing treatment standards that 
these wastes are subject to. Thus, we believe that the rule will not 
pose additional risks to workers or the public. Moreover, the Agency 
notes that since OMP Spring House's waste stream will remain a solid 
waste under RCRA, it retains the authority to require OMP Spring House 
to address any threat which it determines presents an imminent threat 
to the public health or the environment. See 42 U.S.C. 6973(a). 
Further, a core goal of EPA's XL initiative is to promote innovation, 
which includes considering whether new approaches are better able to 
protect the public health and the environment than existing regulatory 
requirements, even where the latter are long-established and required 
significant investment by facilities to comply. Therefore, while EPA 
understands the concerns expressed by these commercial mixed waste 
treatment facilities, the Agency does not believe that these concerns 
are sufficient to preclude the exploration of other approaches or, in 
this specific case, testing the proposition that an NRC license 
provides sufficient protections for the thermal treatment of small 
volumes of research and development LLMW in the same laboratory where 
the wastes are generated. (The Agency notes that these commenters did 
not suggest any specific RCRA regulatory requirement that they thought 
is necessary to protect human health and the environment at OMP Spring 
House's NRC-licensed facility.)

H. How Will This Project Result in Cost Savings and Paperwork 
Reduction?

    OMP Spring House has stated that if it became required to obtain a 
RCRA permit to operate its catalytic oxidation unit, it would instead 
send its small volume of mixed wastes generated to a commercial 
treatment facility.\3\ For mixed wastes, commercial treatment costs are 
typically based primarily upon the level of radioactivity (i.e., number 
of curies) being treated, as well as the volume of the waste. The costs 
range from approximately $20,000-$35,000 per curie, with an average 
cost of $30,000/curie. This represents a $300,000/year cost for OMP 
Spring House, which generates up to 10 curies of mixed waste per year. 
OMP Spring House has stated that other cost savings, such as reduced 
transportation costs and administrative/paperwork savings resulting 
from no longer having its LLMW be defined as a RCRA hazardous waste, 
are relatively minor compared with the costs of commercial LLMW 
treatment.
---------------------------------------------------------------------------

    \3\ OMP Spring House believes that the current RCRA permitting 
requirements are intended to apply primarily to commercial hazardous 
waste treatment facilities, and that it would be difficult to 
justify investing the costs of obtaining and maintaining a RCRA 
Subtitle C permit unless it could recoup such costs through 
commercial activities (i.e., treating wastes generated by other 
generators for a fee). OMP Spring House has stated that it neither 
is nor intends to be in the commercial waste treatment business, and 
therefore it would not seek such a permit.
---------------------------------------------------------------------------

    EPA understands that pharmaceutical, medical, and academic research 
activities, such as the radiolabeling which generates OMP Spring 
House's mixed wastes, are often limited by the high costs of waste 
management. Because waste management costs are such a major factor in 
the budgets allocated to such R&D activities, the high cost of waste 
management can significantly reduce the money actually spent on R&D. 
With more cost-effective treatment (such as OMP Spring House's on-site 
bench-scale catalytic oxidation unit), more money could be spent on the 
actual research and development of pharmaceuticals.

I. What Are the Terms of the OMP Spring House XL Project and How Will 
They Be Enforced?

    To implement this XL pilot project, EPA is today modifying 40 CFR 
261.4(b) by providing a site-specific exemption from the regulatory 
definition of hazardous waste for OMP Spring House's LLMW generated and 
treated in their radiosynthesis laboratory, which is subject to a 
``Type A Broad Scope'' NRC license for research and development. In 
accordance with 25 Pa. Code section 261a.1 of Pennsylvania's RCRA-
authorized hazardous waste program, EPA's exemption of OMP Spring 
House's mixed waste from the regulatory definition of hazardous waste 
under RCRA is automatically incorporated in Pennsylvania's hazardous 
waste regulations because the State hazardous waste regulations 
incorporate 40 CFR 261.4(b) by reference, including any modification or 
additions made to that section by the Federal program.
    Through the development of the Final Project Agreement (FPA), OMP 
Spring House had agreed to comply with several conditions for this 
exemption, which were included in the regulatory text that was proposed 
on July 24, 2001 and are being finalized today. These conditions focus 
on demonstrating the efficacy of the treatment technology, and to 
gather the data and other information that will allow the Agency to 
make a determination regarding the possible future adoption of this 
site-

[[Page 36855]]

specific exemption as a nationwide generic exemption.
    The site-specific exemption is limited to a total volume of 50 
liters/year of mixed waste and only applies to mixed wastes that are 
generated and treated using OMP Spring House's high-temperature 
catalytic oxidation process within the OMP Spring House facility's 
radiosynthesis laboratory. In addition, the exemption is further 
conditioned such that OMP Spring House must report, on a semi-annual 
basis, the following:
    (1) Analysis demonstrating the destruction and removal efficiencies 
for all organic components of the exempted wastes subject to treatment.
    (2) Analysis demonstrating the capture efficiencies for the 
radioactive component of the exempted wastes subject to treatment, and 
an estimate of the amount of radioactivity that was released during the 
reporting period.
    (3) Analyses of the constituent concentrations, including inorganic 
constituents, present and radioactivity of the exempted wastes prior 
to, and after, treatment.
    (4) The volume of exempted wastes treated per batch, as well as a 
total for the duration of the reporting period.
    (5) The final disposition of the radioactive residuals from the 
treatment of the exempted wastes.
    In addition, OMP Spring House commits to work with other companies, 
organizations and research institutes to: (1) Further develop a 
standard, bench-scale off-the-shelf treatment unit, based on its high-
temperature catalytic oxidation technology, to be made available to any 
company or institution that generates similar R&D quantities of mixed 
wastes, and (2) further develop the technology and market for the 
recycling and reuse of the radioactive component of the LLMW (i.e., the 
LLW residuals resulting from the treatment of the LLMW).
    As part of meeting this commitment, OMP Spring House will prepare 
(and submit to EPA for review and comment) a proposed plan summarizing 
how it will accomplish this goal. Because these two commitments involve 
the participation of other companies and entities outside OMP Spring 
House's control and thus are much less certain than the conditions 
discussed above, these commitments have not been made conditions of the 
exemption. However, in evaluating the success of this XL project, these 
``non-enforceable'' commitments will be considered by EPA and the 
PADEP.

J. How Long Will This Project Last and When Will It Be Completed?

    This project will be in effect for five years from the date that 
this final rulemaking becomes effective, unless it is terminated 
earlier or extended by all project signatories (if the FPA and rule are 
extended, this will be done through a rulemaking seeking the comments 
and input of stakeholders and the public). Any project signatory may 
terminate its participation in this project at any time in accordance 
with the procedures set forth in the FPA. The project will be completed 
at the conclusion of the five-year anniversary of today's final 
rulemaking or at a time earlier or later as agreed to by the parties 
involved.

IV. RCRA & Hazardous and Solid Waste Amendments of 1984

A. Applicability of Rules in Authorized States

    Under section 3006 of RCRA, EPA may authorize qualified States to 
administer and enforce the RCRA program for hazardous waste within the 
State. (See 40 CFR Part 271 for the standards and requirements for 
authorization.) States with final authorization administer their own 
hazardous waste programs in lieu of the Federal program. Following 
authorization, a state continues to have enforcement responsibility 
under its State law to pursue violations of its hazardous waste 
program. EPA continues to have independent enforcement authority under 
sections 3007, 3008, 3013 and 7003 of RCRA.
    After authorization, Federal rules issued under RCRA provisions 
that predate the Hazardous and Solid Waste Amendments of 1984 (HSWA), 
no longer apply in the authorized state. New Federal requirements 
imposed by non-HSWA rules do not take effect in an authorized State 
until the State adopts the requirements as State law.
    In contrast, under section 3006(g) of RCRA, new requirements and 
prohibitions imposed by HSWA take effect in authorized States at the 
same time they take effect in nonauthorized States. EPA is directed to 
carry out HSWA requirements and prohibitions in authorized States until 
the State is granted authorization to do so.

B. Effect on Pennsylvania Authorization

    Today's final rule is promulgated pursuant to non-HSWA authority. 
Pennsylvania initially received authority from EPA to implement its 
base hazardous waste program effective January 30, 1986 (see 51 FR 
1791, January 15, 1986). Because EPA clarified that the hazardous waste 
component of mixed waste was subject to RCRA after Pennsylvania 
received its initial RCRA base authorization (see 51 FR 24504, July 3, 
1986), mixed waste was not initially included within Pennsylvania's 
authorized base program. Pennsylvania subsequently applied to EPA, 
seeking approval that its hazardous waste program, as revised 
(including its adoption of regulations governing mixed waste), complied 
with RCRA. Under the terms of the Commonwealth's hazardous waste 
program, subsequent modifications and additions to EPA's RCRA 
regulations as published in the Code of Federal Regulations (with 
certain exceptions not relevant here) are automatically incorporated 
into the Commonwealth's hazardous waste program. See 29 Pa. Bull. 2367, 
2370 (May 1, 1999), 65 FR at 57734 and 57736 (September 26, 2000).
    On September 26, 2000, EPA published notice of Final Authorization 
of Pennsylvania's hazardous waste program, including specifically its 
regulation of mixed waste, effective November 27, 2000. See 65 FR 57734 
and 57736 (September 26, 2000). EPA did not receive any adverse 
comments, and thus EPA's authorization of Pennsylvania's hazardous 
waste program (including mixed wastes) became effective on November 27, 
2000.
    This XL project was undertaken and developed (by EPA, PADEP, and 
OMP Spring House) with the assumption that Pennsylvania would receive 
authorization for mixed wastes, necessitating the regulatory 
flexibility on the part of PADEP to implement the XL project. Since 
Pennsylvania has had RCRA authorization for mixed wastes since November 
27, 2000, and because Pennsylvania's definition of hazardous waste 
under the Pennsylvania Solid Waste Management Act (PaSWMA), including 
its exclusions and exemptions, incorporates RCRA's analogous provisions 
upon their promulgation, this rule will have the effect of exempting 
OMP Spring House's mixed wastes from regulation by the Commonwealth as 
a hazardous waste under its hazardous waste program, which in turn 
allows Pennsylvania to implement this XL project.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735), the Agency must 
determine whether this regulatory action is ``significant'' and 
therefore subject to formal review by the Office of Management and 
Budget (OMB) and to

[[Page 36856]]

the requirements of the Executive Order, which include assessing the 
costs and benefits anticipated as a result of this regulatory action. 
The Order defines ``significant regulatory'' action as one that is 
likely to result in a rule that may: (1) Have an annual effect on the 
economy of $100 million or more or adversely affect in a material way 
the economy, a sector of the economy, productivity, competition, jobs, 
the environment, public health or safety, or State, local, or tribal 
governments or communities; (2) create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    Because this rule affects only one facility, it is not a rule of 
general applicability and therefore is not subject to OMB review and 
Executive Order 12866.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under 
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., 
since it applies to only one facility. It is exempt from OMB review 
under the Paperwork Reduction Act because it is a site-specific rule, 
directed to fewer than ten persons. 44 U.S.C. 3502(3), (10); 5 CFR 
1320.3(c), 1320.4 and 1320.5.
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq., 
as amended by the Small Business Regulatory Enforcement Fairness Act 
(SBREFA) of 1996), whenever an Agency is required to publish a notice 
for any proposed or final rule, it must prepare and make available for 
public comment a regulatory flexibility analysis that describes the 
effect of the rule on small entities (i.e., small businesses, small 
organizations, and small governmental jurisdictions). However, no 
regulatory flexibility analysis is required if the head of an agency 
certifies the rule will not have a significant economic impact on a 
substantial number of small entities. SBREFA amended the Regulatory 
Flexibility Act to require Federal agencies to provide a statement of 
the factual basis for certifying that a rule will not have a 
significant economic impact on a substantial number of small entities. 
This rule will not have a significant impact on a substantial number of 
small entities because it only affects the OMP Spring House facility, 
and it is not a small entity.
    Based on the foregoing discussion, I hereby certify that this rule 
will not have a significant adverse economic impact on a substantial 
number of small entities. Consequently, the Agency has determined that 
preparation of a formal Regulatory Flexibility Analysis is unnecessary.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for federal agencies to assess the 
effects of their regulatory actions on state, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``federal mandates'' that 
may result in expenditures by state, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year.
    Before promulgating a rule for which a written statement is needed, 
section 205 of the UMRA generally requires EPA to identify and consider 
a reasonable number of regulatory alternatives and adopt the least 
costly, most cost-effective or least burdensome alternative that 
achieves the objectives of the rule. The provisions of section 205 do 
not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective, or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enable 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    As noted above, this rule is applicable only to one facility in 
Pennsylvania. EPA has determined that this rule contains no regulatory 
requirements that might significantly or uniquely affect small 
governments. EPA has also determined that this rule does not contain a 
Federal mandate that may result in expenditures of $100 million or more 
for State, local, and tribal governments, in the aggregate, or the 
private sector in any one year. Thus, today's rule is not subject to 
the requirements of sections 202 and 205 of the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications. 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the states, on the relationship between the National 
Government and the states, or on the distribution of power and 
responsibilities among the various levels of government.''
    This rule does not have federalism implications. It will not have a 
substantial direct effect on States, on the relationship between the 
National Government and the States, or on the distribution of powers 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132. Today's rule will only affect one 
facility, providing regulatory flexibility applicable to this specific 
site. Thus, Executive Order 13132 does not apply to this rule.

[[Page 36857]]

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.''
    This final rule, does not have tribal implications. It will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
EPA is currently unaware of any Indian tribes located in the vicinity 
of the facility. Thus, Executive Order 13175 does not apply to this 
rule.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045, ``Protection of Children From Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies 
to any rule that EPA determines (1) is ``economically significant'' as 
defined under Executive Order 12866, and (2) concerns an environmental 
health or safety risk that EPA has reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, the Agency must evaluate the environmental health or 
safety effects of the planned rule on children and explain why the 
planned regulation is preferable to other potential effective and 
reasonably feasible alternatives considered by the Agency.
    This rule is not subject to Executive Order 13045 because it is not 
an economically significant rule as defined by Executive Order 12866, 
and because the Agency believes that the environmental health or safety 
risks addressed by this action do not present a disproportionate risk 
to children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This rule is not a ``significant energy action'' as defined in 
Executive Order 13211, ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) because it is not likely to have a significant 
adverse effect on the supply, distribution, or use of energy. It will 
not result in increased energy prices, increased cost of energy 
distribution, or an increased dependence on foreign supplies of energy.

I. National Technology Transfer and Advancement Act of 1995

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (``NTTAA,'' Public Law 104-113, section 12(d) (15 U.S.C. 
272 note) directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA directs EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards. 
Today's rule does not establish technical standards. Therefore, EPA did 
not consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898, ``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations'' (February 
11, 1994) is designed to address the environmental and human health 
conditions of minority and low-income populations. EPA is committed to 
addressing environmental justice concerns and has assumed a leadership 
role in environmental justice initiatives to enhance environmental 
quality for all citizens of the United States. The Agency's goals are 
to ensure that no segment of the population, regardless of race, color, 
national origin, income, or net worth bears disproportionately high and 
adverse human health and environmental impacts as a result of EPA's 
policies, programs, and activities.
    Today's rule applies to one facility in Pennsylvania. Overall, no 
disproportional impacts to minority or low income communities are 
expected.
    Today's rule applies to one facility in Pennsylvania. Overall, no 
disproportional impacts to minority or low income communities are 
expected.

K. Executive Order 12988: Civil Justice Reform

    In issuing this rule, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 
FR 4729, February 7, 1996).

L. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. Section 804 exempts from section 801 the following types 
of rules (1) rules of particular applicability; (2) rules relating to 
agency management or personnel; and (3) rules of agency organization, 
procedure, or practice that do not substantially affect the rights or 
obligations of non-agency parties. EPA is not required to submit a rule 
report regarding today's action under section 801 because this is a 
rule of particular applicability.

List of Subjects in 40 CFR Part 261

    Environmental protection, Hazardous materials, Waste treatment and 
disposal.

    Dated: June 20, 2005.
Stephen L. Johnson,
Administrator.

0
For the reasons set forth in the preamble, title 40, chapter I of the 
Code of Federal Regulations is amended as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

0
1. The authority citation for part 261 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y), and 
6938.

Subpart A--General

0
2. Section 261.4 is amended by adding paragraph (b)(17) to read as 
follows:


Sec.  261.4  Exclusions.

* * * * *

[[Page 36858]]

    (b) * * *
    (17) Solid waste that would otherwise meet the definition of low-
level mixed wastes (LLMW) pursuant to Sec.  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:
    (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,
    (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
    (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.
* * * * *
[FR Doc. 05-12658 Filed 6-24-05; 8:45 am]
BILLING CODE 6560-50-P