[Federal Register Volume 66, Number 142 (Tuesday, July 24, 2001)]
[Proposed Rules]
[Pages 38396-38405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18408]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 261

[FRL-7017-4]
RIN 2090-AA14


Project XL Site-Specific Rulemaking for the Ortho-McNeil 
Pharmaceutical, Inc. Facility in Spring House, Pennsylvania

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing this 
rule to implement a pilot project under the Project XL program that 
would provide site-specific regulatory flexibility under the Resource 
Conservation and Recovery Act (RCRA), as amended, for the Ortho-McNeil 
Pharmaceutical, Inc. (OMP) facility in Spring House, Pennsylvania. The 
principal objective of this XL project is to determine 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 are also radioactive) that are both 
generated and treated in an NRC-licensed pharmaceutical research and 
development laboratory. Specifically, this XL project will allow for 
the treatment (through high-temperature catalytic oxidation) of small 
volumes of low-level mixed wastes (LLMW) to destroy the organic portion 
of the waste, generating a residual (in which the hazardous organic 
constituents are no longer detected) that can be managed as a low-level 
radioactive waste (i.e., no longer designated as a RCRA mixed waste and 
thus, no longer subject to RCRA regulatory requirements). If, as a 
result of this XL project, the Agency determines that certain small 
volumes of mixed wastes generated and managed in a research and 
development facility 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.
    To implement this XL project, this proposed rule, when finalized, 
will provide a site-specific exclusion from the regulatory definition 
of hazardous waste for the mixed wastes generated and treated in OMP's 
research and development laboratory. The terms of the overall XL 
project are contained in a Final Project Agreement (FPA) which is 
included in the docket for this proposal. A draft version of the FPA 
was the subject of a Notice of Availability published in the Federal 
Register on September 1, 2000 (65 FR 53297) in which EPA solicited 
comment. The FPA was signed on September 22, 2000 by representatives of 
EPA, the Pennsylvania Department of Environmental Protection, and 
Ortho-McNeil Pharmaceutical. This proposed rule, when finalized, will 
allow for the implementation of the FPA.

DATES: Public Comments: Comments on the proposed rule and/or FPA must 
be received on or before August 23, 2001. All comments should be 
submitted in writing to the address listed below.
    Public Hearing: Commenters may request a public hearing by August 
7, 2001, during the public comment period. Commenters requesting a 
public hearing should specify the basis for their request. If EPA 
determines that there is sufficient reason to hold a public hearing, it 
will do so by August 14, 2001, during the last week of the public 
comment period. Requests for a public hearing should be submitted to 
the address below. If a public hearing is scheduled, the date, time, 
and location will be available through a Federal Register notice or by 
contacting Mr. Charles Howland at the U.S. EPA Region III office, at 
the address below.

ADDRESSES: Comments: Written comments should be mailed to the RCRA 
Information Center Docket Clerk (5305W), U.S. Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460. Please send an 
original and two copies of all comments, and refer to Docket Number F-
2001-OMPP-FFFFF.
    Request for a Hearing: Requests for a hearing should be mailed to 
the RCRA Information Center Docket Clerk (5305G), U.S. Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, D.C. 20460. 
Please send an original and two copies of all comments, and refer to 
Docket Number F-2001-OMPP-FFFFF. A copy should also be sent to Mr. 
Charles Howland at U.S. EPA Region III. Mr. Howland may be contacted at 
the following address: U.S. Environmental Protection Agency, Region III 
(3OR00), 1650 Arch Street, Philadelphia, PA, 19103-2029, (215) 814-
2645.
    Viewing Project Materials: A docket containing the proposed rule, 
Final Project Agreement, supporting materials, and public comments is 
available for public inspection and copying at the RCRA Information 
Center (RIC), located at Crystal Gateway, 1235 Jefferson Davis Highway, 
First Floor, Arlington, Virginia. The RIC is open from 9:00am to 4:00pm 
Monday through Friday, excluding Federal holidays. The public is 
encouraged to phone in advance to review docket materials. Appointments 
can be scheduled by phoning the Docket Office at (703) 603-9230. Refer 
to RCRA docket number F-2001-OMPP-FFFFF. The public may copy a maximum 
of 100 pages from any regulatory docket at no charge. Additional copies 
cost 15 cents per page. Project materials are also available for review 
for today's action on the World Wide Web at http://www.epa.gov/projectxl/.
    A duplicate copy of the docket is available for inspection and 
copying at U.S. EPA Library, Region III, 1650 Arch Street, 
Philadelphia, PA 19107 during normal business hours. Persons wishing to 
view the duplicate docket at the Philadelphia location are encouraged 
to contact Mr. Charles Howland in advance, by telephoning (215) 814-
2645.

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 [email protected]). Further information on today's 
action may also be obtained on the World Wide Web at http://www.epa.gov/projectxl/.

SUPPLEMENTARY INFORMATION: All other hazardous wastes generated and/or 
managed at the OMP facility remain subject to current RCRA Subtitle C 
regulations. Similarly, mixed wastes generated in other pharmaceutical 
research and development facilities remain subject to current RCRA 
regulations. 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 may determine whether 
mixed wastes generated and treated in similar circumstances should also 
be excluded from the regulatory definition of hazardous wastes (and 
thus, RCRA regulatory control) by providing such regulatory flexibility 
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

[[Page 38397]]

oxidation unit used to treat the mixed wastes, which will also be 
considered as part of any future determination regarding the 
implementation of the regulatory flexibility on a national basis.
    The exclusion from the regulatory definition of hazardous waste for 
the mixed wastes generated at this Ortho-McNeil Pharmaceutical facility 
will remain in effect only for the five-year term of this XL project. 
The five-year term begins upon the effective date of the final 
rulemaking promulgated to allow for the XL project to be implemented.
    Today's proposed rulemaking will not in any way affect the 
provisions or applicability of any other existing or future 
regulations.
    EPA is soliciting comments on this rulemaking. EPA will publish 
responses to comments in a subsequent final rule, or in a ``Response to 
Comments'' document that will be included in the docket for the final 
rule. The XL project will enter the implementation phase when the final 
rule (or other legal mechanism) is promulgated by EPA and the 
Pennsylvania Department of Environmental Protection (PADEP).

Outline of Today's Proposal

    The information presented in this preamble is organized as follows:

I. Authority
II. Overview of Project XL
III. Overview of the OMP XL Pilot Project
    A. To Which Facilities Will the Proposed Rule Apply?
    B. What Problems will the OMP XL Project Attempt to Address?
    1. Current Regulatory Status of Mixed Wastes
    2. Site-Specific Considerations at the OMP Facility
    C. What Solutions are Proposed by the OMP XL Project?
    D. What Regulatory Changes Will Be Necessary to Implement this 
Project?
    1. Federal Regulatory Changes
    2. State Regulatory Changes
    E. Why is EPA Supporting this Approach to Removing RCRA 
Regulatory Controls Over a Mixed Waste?
    F. How Have Various Stakeholders Been Involved in this Project?
    G. How Will this Project Result in Cost Savings and Paperwork 
Reduction?
    H. What Are the Terms of the OMP XL Project and How Will They Be 
Enforced?
    I. How Long Will this Project Last and When Will It Be 
Completed?
IV. Additional Information
    A. How to Request a Public Hearing
    B. How Does this Rule Comply With Executive Order 12866: 
Regulatory Planning and Review?
    C. Is a Regulatory Flexibility Analysis Required?
    D. Is an Information Collection Request Required for this 
Project Under the Paperwork Reduction Act?
    E. Does this Project Trigger the Requirements of the Unfunded 
Mandates Reform Act?
    F. RCRA & Hazardous and Solid Waste Amendments of 1984
    1. Applicability of Rules in Authorized States
    2. Effect on Pennsylvania Authorization
    G. How Does this Rule Comply with Executive Order 13045: 
Protection of Children from Environmental Health Risks and Safety 
Risks?
    H. How Does this Rule Comply With Executive Order 13132: 
Federalism?
    I. How Does this Rule Comply with Executive Order 13175: 
Consultation and Coordination with Indian Tribal Governments?
    J. Does this Rule Comply with the National Technology Transfer 
and Advancement Act?

I. Authority

    EPA is publishing this proposed 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, 
PADEP, and the OMP Spring House, PA facility with regard to a project 
developed under Project XL, an EPA initiative that allows regulated 
entities to achieve better environmental results with limited 
regulatory flexibility. This proposed regulation, along with the FPA 
(contained in the docket for this proposal), will facilitate 
implementation of the project. Project XL--``eXcellence and 
Leadership''-- was announced on March 16, 1995, as a central part of 
the National Performance Review and 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. These efforts are crucial to 
EPA's ability to test new strategies that reduce regulatory burden and 
promote economic growth while achieving better environmental and public 
health protection. EPA intends to evaluate the results of this and 
other Project XL projects to determine which specific elements of the 
projects, if any, should be more broadly applied to other regulated 
entities for the benefit of both the environment and the economy.
    Under Project XL, participants in four categories--facilities, 
industry sectors, governmental agencies and communities--are offered 
the flexibility to develop common sense, cost-effective strategies that 
will replace or modify specific regulatory requirements, on the 
condition that they produce and demonstrate superior environmental 
performance.
    The XL program is intended to encourage EPA to experiment with 
potentially promising regulatory approaches, both to assess whether 
they provide benefits at the specific facility affected, and whether 
they should be considered for wider application. Such pilot projects 
allow EPA to proceed more quickly than would be possible when 
undertaking changes on a nationwide basis. As part of this 
experimentation, EPA may try out approaches or legal interpretations 
that depart from, or are even inconsistent with, longstanding Agency 
practice, so long as those interpretations are within the broad range 
of discretion enjoyed by the Agency in interpreting the statutes that 
it implements. EPA may also modify rules, on a site-specific basis, 
that represent one of several possible policy approaches within a more 
general statutory directive, so long as the alternative being used is 
permissible under the statute.
    Adoption of such alternative approaches or interpretations in the 
context of a given XL project does not, however, signal EPA's 
willingness to adopt that interpretation as a general matter, or even 
in the context of other XL projects. It would be inconsistent with the 
forward-looking nature of these pilot projects to adopt such innovative 
approaches prematurely on a widespread basis without first determining 
whether they are viable in practice and successful in the particular 
projects that embody them. Furthermore, as EPA indicated in announcing 
the XL program, EPA expects to adopt only a limited number of carefully 
selected projects. These pilot projects are not intended to be a means 
for piecemeal revision of entire programs. Depending on the results in 
these projects, EPA may or may not be willing to consider adopting the 
alternative interpretation again, either generally or for other 
specific facilities.
    EPA believes that adopting alternative policy approaches and 
interpretations, on a limited, site-specific basis and in connection 
with a carefully selected pilot project, is consistent with the 
expectations of Congress about EPA's role in implementing the 
environmental

[[Page 38398]]

statutes (provided that the Agency acts within the discretion allowed 
by the statute). Congress' recognition that there is a need for 
experimentation and research, as well as ongoing re-evaluation of 
environmental programs, is reflected in a variety of statutory 
provisions, such as section 8001 of RCRA.

XL Criteria

    To participate in Project XL, applicants must develop alternative 
environmental performance objectives pursuant to eight criteria: 
superior environmental performance; cost savings and paperwork 
reduction; stakeholder involvement and support; test of an innovative 
strategy; transferability; feasibility; identification of monitoring, 
reporting and evaluation methods; and avoidance of shifting risk 
burden. The XL projects must have the full support of the affected 
Federal, State, local and tribal agencies to be selected.
    For more information about the XL criteria, readers should refer to 
the 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 XL 
project addresses the XL criteria, readers should refer to the Final 
Project Agreement available from the EPA RCRA docket or Region III 
library (see ADDRESSES section of today's preamble).

XL Program Phases

    The Project XL program is compartmentalized into four basic 
developmental phases: the initial pre-proposal phase where the project 
sponsor comes up with an innovative concept that they would like EPA to 
consider as an XL pilot project; the second phase where the project 
sponsor works with EPA and interested stakeholders in developing an XL 
proposal; the third phase where EPA, local regulatory agencies, and 
other interested stakeholders review the XL proposal; and the fourth 
phase where the project sponsor works with EPA, local regulatory 
agencies, and interested stakeholders in developing a Final Project 
Agreement and legal mechanism. After promulgation of the final rule (or 
other legal mechanism) that provides the flexibility required for the 
XL pilot project, and after the Final Project Agreement has been signed 
by all designated parties, the XL pilot project proceeds onto 
implementation and evaluation.

Final Project Agreement

    The Final Project Agreement (FPA) is a written voluntary agreement 
between the project sponsor and regulatory agencies. The FPA contains a 
detailed description of the proposed pilot project. It addresses the 
eight Project XL criteria, and the expectation of the Agency that the 
XL project will meet those criteria. The FPA identifies performance 
goals and indicators that the project is yielding the expected 
environmental benefits, and specifically addresses the manner in which 
the project is expected to produce superior environmental benefits. The 
FPA also discusses the administration of the FPA, including dispute 
resolution and termination. The FPA for this XL project is available 
for review in the docket for today's action, and also is available on 
the World Wide Web at http://www.epa.gov/projectxl/.

III. Overview of the OMP XL Pilot Project

    EPA is today requesting comments on the proposed rule to implement 
key provisions of this Project XL initiative. Today's proposed rule 
would facilitate implementation of the FPA that has been developed by 
EPA, the Pennsylvania Department of Environmental Protection (PADEP), 
the Ortho-McNeil Pharmaceutical Spring House, PA facility, and other 
stakeholders. Today's proposed rule, when finalized, will automatically 
become effective under Pennsylvania State law in accordance with the 
Commonwealth's hazardous waste program, as described further in section 
IV.F. of this preamble.

A. To Which Facilities Will the Proposed Rule Apply?

    This proposed rule, when finalized, would apply only to the OMP 
Spring House, PA facility. Further, the regulatory modification being 
proposed only affects the mixed waste that is the focus of this XL 
project; hazardous wastes resulting from any other operations at the 
facility are not affected by this proposed rule (or the final rule, 
when finalized).

B. What Problems Will the OMP XL Project Attempt to Address?

    OMP does not believe the RCRA Subtitle C regulatory controls, as 
applied to the LLMW it generates and treats, provide any additional 
environmental protection than is otherwise provided by AEA oversight, 
but rather, RCRA Subtitle C regulatory controls serve as a major 
disincentive to the environmentally protective on-site treatment of the 
small volume of mixed wastes generated at the facility. While 
commercial treatment for such wastes is available, the on-site, bench-
scale, high-temperature catalytic oxidation unit OMP 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 organics than available 
commercial treatment. (The on-site treatment of OMP's mixed wastes has 
been extensively tested under a ``treatability study'' exemption 
provided in 40 CFR 261.4(f) granted by PADEP.) According to OMP, it 
does not intend to pursue 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 waste 
generated. Nor does OMP intend to become a commercial mixed waste 
treatment facility and receive mixed wastes from off-site in order to 
recover the costs of a RCRA permit. Further, the costs of existing off-
site commercial treatment for the small volume of mixed wastes 
generated are very high and therefore limit the research and 
development of new pharmaceuticals because the waste management costs 
associated with these activities represent such a large percentage of 
the research and development budget.
1. Current Regulatory Status of Mixed Wastes
    Mixed waste is a radioactive hazardous waste, subject to two 
statutory authorities: (1) The Resource Conservation and Recovery Act 
(RCRA) as implemented by EPA (or States authorized by EPA) with 
jurisdiction over the hazardous waste component; and (2) the Atomic 
Energy Act (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. 
The management of the mixed wastes that are the subject of this XL 
pilot project are therefore 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 low-level mixed waste (LLMW) is 
excessively burdensome, duplicative and costly without providing any 
additional protection of human health and the environment than that 
achieved under one regulatory regime. In response to these concerns, on 
April 30, 2001 EPA

[[Page 38399]]

Administrator Christine Todd Whitman signed a final mixed waste rule 
modifying the current regulatory framework to provide flexibility 
related to the storage, treatment (certain kinds of treatment), 
transportation and disposal for LLMW (see 66 FR 27217, May 16, 2001). 
This rule will become effective on November 13, 2001.
    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. Accordingly, the 
Agency adopted a conditional exemption from certain RCRA hazardous 
waste management requirements for NRC-licensed generators of LLMW.
    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. (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, a 
generator to treat LLMW generated under a single NRC or NRC Agreement 
State license, in tanks or containers, provided the form of treatment 
is allowed under its NRC or NRC Agreement State license. The 
conditional exemption is only available to generators of LLMW that are 
licensed by the NRC or NRC Agreement States. In addition, LLMW that 
meets the applicable LDR standards (either as generated or through 
treatment) may be transported and disposed of as a LLW at an NRC or NRC 
Agreement State licensed low level radioactive waste disposal facility 
(LLRWDF).
    The treatment technology being employed by OMP is not exempted 
under the Mixed Waste Rule because it does not within a tank or 
container. The Agency determined that more specific controls (as are 
provided under RCRA) are more appropriate for certain forms of 
treatment, such as incineration, due to the complexity of the treatment 
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.
2. Site-Specific Considerations at the OMP Facility
    Ortho-McNeil Pharmaceutical (OMP) in Spring House, Pennsylvania 
conducts research and development of pharmaceuticals/drugs. OMP 
develops and utilizes radiolabeled compounds to conduct this research 
and development, specifically to study the bioabsorption and metabolism 
of the drugs, in compliance with Food and Drug Administration (FDA) 
requirements. The radiolabeled compounds 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 (for which NRC has jurisdiction) and 
a hazardous organic component (for which EPA has jurisdiction). This 
radioactive/hazardous organic waste mixture is the low-level mixed 
waste (LLMW) that is the focus of this XL pilot project. The estimated 
volume of mixed waste produced per batch ranges from less than 50 
milliliters to several liters, with an annual total volume of less than 
50 liters.
    OMP has developed an innovative bench-scale treatment process 
(i.e., a high-temperature catalytic oxidization unit), which oxidizes 
the mixed waste, thereby destroying its hazardous components (yielding 
water and C2) 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.
    In general, the treatment unit consists of an electrically heated, 
stainless steel tube packed with platinum catalyst, with the heat being 
provided using a tube furnace equipped with three separately controlled 
heating zones. The commercially available tube furnace has an interior 
volume measuring 57.4cm long, with a diameter of 7.6cm. The catalyst 
tube measures 117cm long with an inside diameter of 28.6 mm, and is 
packed in three sections. The first section (i.e., the entrance to the 
catalyst bed) is packed with 15g of untreated alumina pellets. The 
second section (approximately 152mm long) is packed with 100g of 0.5% 
platinum metal coated on 3.2mm pellets of gamma alumina. The final 
portion of the catalyst bed consists of 430g of untreated alumina 
pellets. Liquid samples of LLMW are pumped into the heated (start-up 
temperature is set at 750 deg.C, with a maximum operational temperature 
of 850 deg.C) catalyst tube through a 0.51mm stainless steel inlet tube 
using a positive displacement pump providing a steady and pulseless 
flow. Either air or oxygen is used as the oxidant gas depending on the 
type of LLMW being processed.
    A safety monitoring system providing basic on/off control of the 
pump monitors both high and low gas pressure and temperature during 
operation. An unsafe condition, such as no oxygen flow, excess back 
pressure or high temperature, is quickly detected and causes the 
monitor to turn off electric power to the sample pump, placing the unit 
in a safe standby mode until reset by an operator.
    The tritiated water, radioactive carbon dioxide and other by-
products of the catalytic oxidation of the LLMW are effectively 
collected in a series of pressure-tight trapping vessels. For tritium-
labeled materials, three dry-ice cooled cold traps are used in series. 
For this type of LLMW, the hot effluent stream passes into a 2-liter 
flask cooled with dry ice, in which the vapors condense into liquids. 
Uncollected vapors are passed through a water-cooled reflux condenser 
and then through two dry-ice cooled 1L round bottom flasks connected in 
series to complete condensation. For carbon 14-labeled materials, the 
exit gases are first cooled by passing through a water-cooled glass 
heat exchanger and then through a series of four 1-liter gas scrubbing 
bottles. The bottles are charged with a 45% solution of potassium 
hydroxide, which is dilute enough to solubolize the potassium carbonate 
that is produced when completely saturated with carbon dioxide. 
Additional traps may be added in series for either type of LLMW to 
increase capacity or achieve greater recovery of radioactive by-
products, and the materials collected in the trapping vessels can be 
run through the treatment process again to achieve a higher destruction 
and removal efficiency if the first pass was not effective. Also, other 
by-products of the treatment process (e.g., hydrochloric acid or nitric 
acid, depending on the composition of the LLMW) can be effectively 
trapped and recovered. [Note that a more complete

[[Page 38400]]

technical description of the treatment unit, operational parameters and 
analytical methodology is presented in a document titled ``A Prototype 
High-Temperature Catalytic Oxidation Process For Mixed Waste In A 
Pharmaceutical Research Laboratory,'' available in the docket for this 
proposal.]
    The treatment of carbon-14 labeled compounds generates radioactive 
CO2 (which, as described above, is converted to potassium 
carbonate) and the treatment of tritium labeled compounds generates 
radioactive (i.e., tritiated) water. These residual low-level wastes 
could then be sent off-site for stabilization and disposal under NRC or 
NRC Agreement State regulation. [The Agency notes that because the 
residuals are more homogeneous, they are more amenable to recycling 
(e.g., recovery of tritium); however, recycling the small volumes of 
residuals currently being generated at the OMP Spring House facility is 
not currently economically viable.] 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 only 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's Spring House facility 
is 50 liters per year, which is about the same as the volume for the 
original LLMW (i.e., less than 50 liters per year).
    OMP 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 Pennsylvania 
Department of Environmental Protection (PADEP). This treatability study 
is being 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. To date, the 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. Therefore, the treatment process exceeds LDR 
treatment standards for organics and only negligible amounts of 
radioactivity are released.\1\
---------------------------------------------------------------------------

    \1\ During calendar year 1999, air emissions monitoring revealed 
an annual average concentration of 3.55E-12 uCi/mL for tritium and 
3.03E-11 uCi/mL for carbon-14. This volume of air emissions is less 
than 0.05% of the limits specified by NRC in 10 CFR Part 20 for 
allowable concentrations in effluent air (i.e., 2.00E-8 uCi/mL for 
tritium and 6.00E-8 uCi/mL for carbon-14). Note that these units are 
expressed in microcuries
(10-6 curies)/milliliter.
---------------------------------------------------------------------------

    The catalytic oxidation unit is housed in a laboratory fume hood 
within OMP'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 Proposed by the OMP XL Project?

    OMP's position is that it would like to continue to use the bench-
scale high-temperature catalytic oxidation unit to treat the mixed 
wastes it generates without having to acquire a RCRA permit (although 
the laboratory in which the wastes are generated and treated will 
continue to be subject to an NRC license), and that the residuals from 
the treatment process be ``delisted'' (pursuant to 40 CFR 260.22) such 
that the residuals are no longer RCRA hazardous wastes (and thus not 
subject to RCRA manifesting or disposal permit requirements). OMP 
believes that the NRC license that covers the laboratory during the 
development of the radiolabeled compounds and the generation of the 
mixed waste (as well as the treatment of the mixed waste) is sufficient 
to protect human health and the environment, 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. An additional requirement 
to obtain a RCRA permit will not afford any increase in protectiveness.
    Moreover, OMP has stated that if it is required to obtain a RCRA 
permit to operate the catalytic oxidation unit, it will cease to 
operate the unit and instead will opt to send the small volumes of 
mixed wastes off-site to a commercial mixed waste facility. And 
although the commercial facility has a RCRA permit, OMP's position is 
that the catalytic oxidation unit is more efficient at destroying the 
organics and preventing the release of radioactivity, thus providing a 
superior environmental performance relative to existing commercial 
treatment available for mixed wastes.
    Therefore, OMP's opinion is that the most practical outcome of this 
project is for OMP to continue to be able to treat the small volumes of 
mixed wastes within the same laboratory that created the wastes, under 
the regulatory oversight provided by the NRC license (rather than 
RCRA), and that the residual wastestream (after treatment in the 
catalytic oxidation unit) be removed from RCRA jurisdiction because the 
organics (i.e., the constituents that initially ``trigger'' RCRA 
regulation of the mixed wastes) are no longer found in the treatment 
residuals.
    As an additional point, should the regulatory flexibility (and the 
resulting significant cost savings), provided for this XL project be 
promulgated on a permanent basis, OMP expects to be able to invest 
significantly more in research and development of pharmaceuticals to 
the benefit of society as a whole. One side effect of such a boon to 
pharmaceutical research and development, however, is the generation of 
greater volumes of LLMW. OMP estimates that if the regulatory 
flexibility being provided through this XL project were to be 
promulgated permanently, the volume of curies of LLMW being generated 
through the research and development activities could increase from the 
current 10 curies/year to approximately 50 curies/year. OMP notes that 
even if greater volumes of LLMW are generated, the environment will 
continue to benefit through the use of the high-temperature catalytic 
oxidation to treat the mixed wastes because of its superior performance 
in destroying organics and capturing radioactivity, relative to 
available commercial treatment capacity for mixed wastes.

D. What Regulatory Changes Will Be Necessary To Implement This Project?

    To allow for this XL project to be implemented, the Agency is 
proposing in today's notice to provide a site-specific exclusion in 40 
CFR 261.4(b) (i.e., ``Solid wastes which are not

[[Page 38401]]

hazardous wastes'') for the mixed wastes generated and treated in OMP'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, an approach that varies slightly from the approach taken in 
the Mixed Waste Rule. Instead of being considered ``mixed wastes,'' 
these wastes will simply be considered low-level wastes (LLWs) subject 
to NRC or NRC Agreement State regulation. 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 was not a RCRA 
``listed'' waste). And while this is not the specific regulatory 
flexibility that OMP requested, the Agency believes this regulatory 
mechanism is the most efficient way to provide OMP with the regulatory 
outcome it seeks.
    The site-specific exclusion being proposed 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 whether the regulatory flexibility 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.H.

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

    The Agency agrees with OMP that this XL project has merit and has 
the potential to result in significant environmental benefits should 
the regulatory flexibility be adopted on a national basis. While the 
Agency has recently adopted the Mixed Waste Rule to generically address 
the regulation of mixed wastes, Project XL offers the Agency the 
opportunity to test alternative approaches, and in this case, an 
alternative approach tailored to a specific subset of the generic 
category of ``mixed wastes.'' EPA's Mixed Waste Rule, which 
conditionally exempts LLMW from the RCRA regulatory definition of 
hazardous waste for certain waste management activities that are 
subject to an NRC or NRC Agreement State license, however, will not 
provide the regulatory flexibility that OMP seeks (the rule does not 
exempt OMP's high temperature catalytic oxidation process). While the 
Agency continues to maintain that, as a general rule, mixed waste 
treatment processes that cannot be undertaken in a tank or container 
warrant RCRA oversight, the Agency also believes it is appropriate to 
test whether a particular mixed waste treatment process (that occurs 
outside of a tank or container) for a discrete subset of mixed wastes 
may be adequately regulated under the NRC regulatory regime.
    In this specific XL pilot project, EPA is testing its belief that, 
in certain scenarios (e.g., small volumes of pharmaceutical R&D-
generated LLMW being treated by a bench-scale high temperature 
catalytic oxidation unit in an NRC-licensed laboratory), NRC regulatory 
oversight provides sufficient safeguards to ensure protection of human 
health and the environment without additional RCRA Subtitle C 
oversight. In other words, while the Agency maintains that its concerns 
regarding the general issue of certain forms of treatment of mixed 
wastes are warranted, EPA believes the case-specific considerations 
present here (e.g., 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 sophisticated level of 
expertise of the technicians that work in the laboratory, and the 
protective controls required by the NRC license) warrant a test as an 
exception to the general rule.
    Indeed, this is the type of ``test'' 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 generic ``mixed waste'' as well as possible discrete subsets of 
``mixed waste'' that may be amenable to an alternative regulatory 
approach.

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

    OMP and other industrial facilities in the local area enjoy a good 
working relationship with the local residential community. During the 
developmental stages of this XL pilot project, OMP 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.
    The local community has been involved in this XL project through 
several means. OMP actively participates in two community environmental 
groups: the Lower Gwynedd Township Industrial Compact (``Compact'') and 
the Community Advisory Council (CAC). The Compact consists of members 
of the five major industrial facilities in Lower Gwynedd Township 
(LGT), including OMP, plus the LGT Supervisors, Township Manager, Fire 
Marshal and two township citizens. The Compact meets quarterly and 
provides a regular forum for open discussions about all relevant, 
useful information about the use of hazardous substances within LGT and 
other environmentally related issues. The Compact has provided a 
particularly useful venue for stakeholder outreach and participation.
    As stated above, OMP is also a regular member of the CAC. The CAC 
has approximately 30 community residents who meet to discuss local 
business issues, including environmental issues, on a quarterly basis. 
During the development stages of this project, OMP provided continuous 
updates on this XL project to the Compact and CAC and plans to continue 
updating the community groups during the implementation of the XL pilot 
project.
    Also, OMP hosted a public meeting at the OMP facility on this XL 
pilot project on February 28, 2000. OMP announced the acceptance of the 
project by EPA and invited the community to attend the public meeting 
at a LGT Supervisor meeting on February 16, 2000. A newspaper article 
announcing the public meeting was published in a local newspaper (The 
Reporter) on February 16, 2000. OMP also personally invited all the 
members of the LGT Compact and the CAC, as well as the Executive 
Director of the local Wissahickon Valley Watershed Association, to 
attend the public meeting. A post-public meeting article was published 
in the Ambler Gazette (another local newspaper) on March 1, 2000.
    On July 18, 2000, OMP hosted a second stakeholder meeting at its 
Spring House facility. The meeting was attended by representatives from 
EPA, PADEP, OMP and Johnson & Johnson and focused specifically on 
concerns raised by the Sierra Club, which was also represented at the 
meeting. The Sierra Club representative was thoroughly briefed about 
the EPA Project XL Program, as well as about all aspects of this 
specific XL project, and attendees were given a tour of the 
radiosynthesis laboratory suite in which the mixed wastes are both 
generated and treated. After the meeting, the Sierra Club submitted 
extensive comments on the draft FPA (which was in development at the 
time). The FPA was modified to address these comments.

[[Page 38402]]

    OMP will continue to hold public meetings with the local community 
to provide updates and information on this XL pilot project, as needed.

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

    As stated earlier, if OMP is required to obtain a RCRA permit to 
operate the catalytic oxidation unit, it will decline to seek such a 
permit and instead will send the small volume of mixed wastes generated 
to a commercial treatment facility.\2\ 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. For OMP, which 
generates up to 10 curies of mixed waste per year, this represents 
$300,000/year. Other cost savings, such as reduced transportation costs 
and administrative/paperwork savings resulting from no longer having 
this wastestream be defined as a RCRA hazardous waste (i.e., mixed 
waste), are relatively minor compared with the costs of commercial LLMW 
treatment.
---------------------------------------------------------------------------

    \2\ OMP's belief is that the current RCRA permitting 
requirements are intended to apply to commercial hazardous waste 
treatment facilities. Economically, it would be difficult to justify 
investing the costs of obtaining and maintaining a RCRA Subtitle C 
permit unless OMP sought to recoup such costs through commercial 
activities (i.e., treating wastes generated by other generators and 
charging a fee for this service). OMP states that it is not in the 
commercial waste treatment business, nor does it ever intend to be, 
and therefore, it would not seek such a permit.
---------------------------------------------------------------------------

    EPA understands that research activities, such as the radiolabeling 
which generates OMP'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 significantly reduces the money actually spent on 
R&D. With more cost-effective treatment (such as OMP's on-site bench-
scale catalytic oxidation unit), more money could be spent on the 
actual research and development of pharmaceuticals. OMP estimates that 
if the synthesis research that currently generates the mixed wastes was 
not severely restricted by current waste disposal options and the costs 
associated with these options, the amount of curies of mixed wastes 
being generated at its facility could increase from the current 10 
curies/year to approximately 50 curies/year (which could increase OMP's 
cost savings to $1.5 million annually).

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

    As stated earlier, to implement this XL pilot project, EPA proposes 
to amend 40 CFR 261.4(b) to provide a site-specific exclusion from the 
regulatory definition of hazardous waste for OMP's low-level mixed 
wastes 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 exclusion 
of OMP's mixed waste from the regulatory definition of hazardous waste 
under RCRA will be 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 
has agreed to comply with several conditions for this exclusion, which 
will be included in the regulatory text of the exclusion being proposed 
today. These conditions are focused on proving 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-specific exclusion as a nationwide generic 
exclusion.
    The site-specific exclusion proposed here will be limited to a 
total volume of 50 liters/year of mixed waste and only applies to mixed 
wastes that are generated and treated using the high-temperature 
catalytic oxidation process within the OMP Spring House facility's 
radiosynthesis laboratory. In addition, the exclusion is further 
conditioned such that OMP must report, on a semi-annual basis, the 
following:
    (1) Analysis demonstrating the destruction and removal efficiencies 
for all organic components of the excluded wastes subject to treatment.
    (2) Analysis demonstrating the capture efficiencies for the 
radioactive component of the excluded 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 excluded wastes prior to 
and after being treated.
    (4) The volume of excluded 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 excluded wastes.
    In addition, OMP 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 all 
companies and institutions that generate 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 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's control and 
so are much less certain than the conditions discussed above, these 
commitments are not being made conditions of the exclusion. However, in 
evaluating the success of this XL project, these ``non-enforceable'' 
commitments will be considered by EPA and PADEP.

I. 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 
the 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 the final rulemaking 
or at a time earlier or later as agreed to by the parties involved.

IV. Additional Information

A. How To Request a Public Hearing

    A public hearing will be held, if requested, to provide opportunity 
for interested persons to make oral presentations regarding this 
regulation in accordance with 40 CFR Part 25. Persons wishing to make 
an oral presentation on the site-specific rule to implement the OMP XL 
project should contact Mr. Charles Howland of the Region III EPA 
office, at the address given in the ADDRESSES section of this document. 
Any member of the public may file a written statement before the 
hearing, or after the hearing, to be

[[Page 38403]]

received by EPA no later than August 23, 2001. Written statements 
should be sent to EPA at the addresses given in the ADDRESSES section 
of this document. If a public hearing is held, a verbatim transcript of 
the hearing, and written statements provided at the hearing will be 
available for inspection and copying during normal business hours at 
the EPA addresses for docket inspection given in the ADDRESSES section 
of this preamble.

B. How Does This Rule Comply With Executive Order 12866: Regulatory 
Planning and Review?

    Because this rule affects only one facility, it is not a rule of 
general applicability and therefore not subject to OMB review and 
Executive Order 12866. In addition, OMB has agreed that review of site-
specific rules under Project XL is not necessary.

C. Is a Regulatory Flexibility Analysis Required?

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
generally requires an agency to conduct a regulatory flexibility 
analysis of any rule subject to notice and comment rulemaking 
requirements unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small businesses, small not-for-profit 
enterprises, and small governmental jurisdictions. This rule will not 
have a significant impact on a substantial number of small entities 
because it only affects the OMP facility in Spring House, PA and it is 
not a small entity. Therefore, EPA certifies that this action will not 
have a significant economic impact on a substantial number of small 
entities.

D. Is an Information Collection Request Required for This Project Under 
the Paperwork Reduction Act?

    This action applies only to one facility, and therefore requires no 
information collection activities subject to the Paperwork Reduction 
Act, and therefore no information collection request (ICR) will be 
submitted to OMB for review in compliance with the Paperwork Reduction 
Act, 44 U.S.C. 3501, et seq.

E. Does This Project Trigger the Requirements of the 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 to State, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before promulgating an EPA 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 of 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, enabling 
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.

F. RCRA & Hazardous and Solid Waste Amendments of 1984

1. 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, Pennsylvania would continue 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 pre-date 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.
2. Effect on Pennsylvania Authorization
    Today's proposed rule, if finalized, would be promulgated pursuant 
to non-HSWA authority, rather than HSWA. 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 issued regulations clarifying 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 (Sept. 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

[[Page 38404]]

November 27, 2000. See 65 FR at 57734 and 57736 (Sept. 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 November 27, 2000.
    This XL project was undertaken and developed (by EPA, PADEP, and 
OMP) 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, 
incorporates RCRA's analogous provisions upon their promulgation, this 
rule, upon adoption by Pennsylvania, will have the effect of excluding 
OMP's mixed wastes from regulation by the Commonwealth as a hazardous 
waste under its hazardous waste program.

G. How Does This Rule Comply With Executive Order 13045: Protection of 
Children From Environmental Health Risks and Safety Risks ?

    The Executive Order 13045, ``Protection of Children from 
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 
1997) applies to any rule that: (1) Is determined to be ``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 potentially 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 it does not involve decisions based on environmental health 
or safety risks.

H. Does This Rule Comply With 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 and 
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.''
    The proposed 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 various levels of government, as 
specified in Executive Order 13132. The proposed rulemaking will only 
affect one facility, providing regulatory flexibility applicable to 
this specific site. Thus, Executive Order 13132 does not apply to this 
proposed rule.

I. How Does This Rule Comply With 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 proposed 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.

J. Does This Rule Comply With the National Technology Transfer and 
Advancement Act?

    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 standard. This 
proposed rulemaking does not involve technical standards. Therefore, 
EPA is not considering the use of any voluntary consensus standards. 
EPA welcomes comments on this aspect of the proposed rulemaking and, 
specifically, invites the public to identify potentially-applicable 
voluntary consensus standards and to explain why such standards should 
be used in this regulation.

List of Subjects in 40 CFR Part 261

    Environmental protection, Hazardous materials, Waste treatment and 
disposal.

    Dated: July 18, 2001.
Christine Todd Whitman,
Administrator.
    For the reasons set forth in the preamble, Part 261 of chapter I of 
title 40 of the Code of Federal Regulations is proposed to be amended 
as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

    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

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


Sec. 261.4  Exclusions.

* * * * *
    (b) * * *
    (17) Mixed waste that would otherwise meet the definition of a 
hazardous waste pursuant to Sec. 261.3 that is generated and treated 
using an on-site bench-scale high temperature catalytic oxidation unit 
at the Ortho-McNeil Pharmaceutical, Inc. (OMP) research and development 
facility in Spring House, Pennsylvania are excluded from the definition 
of hazardous waste provided that:
    (i) The total volume of mixed waste that would otherwise meet the 
definition of a hazardous waste pursuant to 261.3 that is subject to 
this exclusion is no greater than 50 liters/year,

[[Page 38405]]

    (ii) OMP submits a written report to the EPA Region III office once 
every six months beginning six months after [EFFECTIVE DATE OF THE 
FINAL RULE] 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 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 effect for 5 years from [the 
effective date of the final rule].
* * * * *
[FR Doc. 01-18408 Filed 7-23-01; 8:45 am]
BILLING CODE 6560-50-U