Source: https://www.scribd.com/document/2847321/Rule-Air-programs-approval-and-promulgation-State-plans-for-designated-facilities-and-pollutants-Ortho-McNeil-Pharmaceutical-Inc-facility-Spri
Timestamp: 2019-06-25 14:00:48
Document Index: 215455771

Matched Legal Cases: ['art 261', 'art 20', 'art 271', 'art 9', 'art 261', 'ART 261', 'art 261', '§ 261', '§ 266']

Rule: Air programs; approval and promulgation; State plans for designated facilities and pollutants: Ortho-McNeil Pharmaceutical, Inc., facility, Spring House, PA | Resource Conservation And Recovery Act | Hazardous Waste
Rule: Air programs; approval and promulgation; State plans for designated facilities and pollutants: Ortho-McNeil Pharmaceutical, Inc., facility, Spring House, PA, 36850-36858 [05-12658] Environmental Protection Agency
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SENATE HEARING, 105TH CONGRESS - REGIONAL HAZE AND MERCURY POLLUTION
Notice: Committees; establishment, renewal, termination, etc.: Aircraft public water systems; workshop
36850 Federal Register / Vol. 70, No.
122 / Monday, June 27, 2005 / Rules and Regulations
jurisdiction in Bernalillo County on i.e., CBI or other information whose E. Executive Order 13132: Federalism
lands under the jurisdiction of the disclosure is restricted by statute. F. Executive Order 13175: Consultation
Albuquerque/Bernalillo County Air Certain other material, such as and Coordination With Indian Tribal
Quality Control Board. copyrighted material, is not placed on G. Executive Order 13045: Protection of
[FR Doc. 05–12657 Filed 6–24–05; 8:45 am] the Internet and will be publicly Children From Environmental Health
available only in hard copy form. and Safety Risks
Publicly available docket materials are H. Executive Order 13211: Actions That
available either electronically in Significantly Affect Energy Supply,
EDOCKET or in hard copy at the RCRA Distribution, or Use
ENVIRONMENTAL PROTECTION I. National Technology Transfer and
AGENCY Docket, EPA/DC, EPA West, Room
B102, 1301 Constitution Ave., NW.,
40 CFR Part 261 Washington, DC. The Public Reading To Address Environmental Justice in
Room is open from 8:30 a.m. to 4:30 Minority Populations and Low-Income
[RCRA–2001–0021; FRL–7928–8]
p.m., Monday through Friday, excluding Populations
RIN 2090–AA14 legal holidays. The telephone number K. Executive Order 12988: Civil Justice
for the Public Reading Room is (202) Reform
Project XL Site-Specific Rulemaking 566–1744, and the telephone number for L. Congressional Review Act
for the Ortho-McNeil Pharmaceutical, the RCRA Docket is (202) 566–0270. I. Authority
Inc. Facility in Spring House, PA FOR FURTHER INFORMATION CONTACT: Mr.
Involving On-Site Treatment of Mixed EPA is publishing this regulation
Charles Howland, U.S. Environmental under the authority of sections 2002,
Wastes Protection Agency, Region III (3OR00), 3001, 3002, 3003, 3006, 3007, 3010,
AGENCY: Environmental Protection 1650 Arch Street, Philadelphia, PA, 3013, and 7004 of the Solid Waste
Agency (EPA). 19103–2029. Mr. Howland can be Disposal Act of 1970, as amended by the
ACTION: Final rule. reached at (215) 814–2645 (or Resource Conservation and Recovery
howland.charles@epa.gov). Act, as amended (42 U.S.C. 6912, 6921,
SUPPLEMENTARY INFORMATION: 6922, 6923, 6926, 6927, 6930, 6934, and
Agency (EPA) is today finalizing this
6974).
rule to implement a pilot project under Outline of Today’s Rule
the Project XL program, providing site- The information presented in this II. Overview of Project XL
specific regulatory flexibility under the preamble is organized as follows: The Final Project Agreement (FPA)
Resource Conservation and Recovery sets forth the intentions of EPA,
Act (RCRA), as amended, for the Ortho- Pennsylvania Department of
McNeil Pharmaceutical, Inc. facility in III. Overview of the OMP Spring House XL Environmental Protection (PADEP), and
Spring House, Pennsylvania (OMP Pilot Project the OMP Spring House facility with
Spring House). The principal objective A. To Which Facilities Does the Final Rule regard to a project developed under
of this XL project is to obtain Apply? Project XL, an EPA initiative that allows
information helpful to determining B. What Problems Does the OMP Spring regulated entities to achieve better
whether regulatory oversight by the House XL Project Attempt To Address?
environmental results with additional
Nuclear Regulatory Commission (NRC), 1. Current Regulatory Status of Mixed
Wastes regulatory flexibility. This final
or NRC Agreement States, under regulation, along with the FPA
2. Site-Specific Considerations at the OMP
authority of the Atomic Energy Act Spring House Facility (contained in the docket for this rule
(AEA) is sufficient to ensure protection C. What Solution Is Being Tested by the under Docket ID No. RCRA–2001–0021),
of human health and the environment OMP Spring House XL Project? will facilitate implementation of the
regarding the management of certain D. What Regulatory Changes Are Being project. Project XL —‘‘eXcellence and
small volumes of mixed wastes (i.e., Made to Implement this Project? Leadership’’— was announced on
RCRA hazardous wastes that also E. Why is EPA Promulgating This
March 16, 1995, as a central part of the
contain radioactive materials) that are Approach To Removing RCRA
Regulatory Controls Over a Mixed Agency’s effort to reinvent
both generated and treated in an NRC- environmental protection. See 60 FR
licensed pharmaceutical research and F. How Have Various Stakeholders Been 27282 (May 23, 1995). Project XL
development laboratory. If, as a result of Involved in this Project? provides a limited number of private
this XL project, the Agency determines G. Response to Major Comments Received and public regulated entities an
that certain small volumes of low-level on the Proposed Rule opportunity to develop their own pilot
mixed wastes (LLMW) generated and H. How Will This Project Result in Cost projects to request regulatory flexibility
managed under NRC oversight need not Savings and Paperwork Reduction? that will result in environmental
also be subject to RCRA hazardous I. What Are the Terms of the OMP Spring
House XL Project and How Will They Be
protection that is superior to what
waste regulations to ensure protection of would be achieved through compliance
human health and the environment, J. How Long Will This Project Last and with current and reasonably-anticipated
EPA may consider adopting the When Will It Be Completed? future regulations. For more information
approach on a national basis. IV. RCRA & Hazardous and Solid Waste about the XL Program in general, and
DATES: Effective Date: This final rule is Amendments of 1984 XL project criteria and project
effective on June 27, 2005. A. Applicability of Rules in Authorized development processes in detail, readers
ADDRESSES: EPA has established a States should refer to http://www.epa.gov/
docket for this action under Docket ID B. Effect on Pennsylvania Authorization projectxl/. Additional background
No. RCRA–2001–0021. All documents A. Executive Order 12866: Regulatory
information on the proposed OMP
in the docket are listed in the EDOCKET Planning and Review Spring House Project XL site-specific
index at http://www.epa.gov/edocket. B. Paperwork Reduction Act rulemaking published is available at
Although listed in the index, some C. Regulatory Flexibility Act http://www.epa.gov/projectxl/ortho/
information is not publicly available, D. Unfunded Mandates Reform Act index.htm and published in the Federal
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Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Rules and Regulations 36851
Register, specifically: July 24, 2001 (66 program.) Further, the regulatory authorized by EPA) with jurisdiction
FR 38396), two descriptive documents modification will only affect the mixed over the hazardous waste component;
published in the Federal Register (60 waste that is the focus of this XL project; and (2) the AEA as implemented by
FR 27282, May 23, 1995 and 62 FR hazardous wastes resulting from any either the Department of Energy (DOE),
19872, April 23, 1997), and the other operations at the OMP Spring or the Nuclear Regulatory Commission
December 1, 1995 ‘‘Principles for House facility are not affected by today’s (NRC) (or its Agreement States) with
Development of Project XL Final Project final rule. jurisdiction over the radioactive
Agreements’’ document. For further component of the waste. Therefore,
B. What Problems Will the OMP Spring
discussion as to how the OMP Spring absent today’s regulatory modification,
House XL Project Attempt To Address?
House XL project addresses the XL the management of the mixed wastes
criteria, readers should refer to the Final The OMP Spring House facility does that are the subject of this XL pilot
Project Agreement available from the not believe the RCRA Subtitle C project would continue to be subject to
EPA RCRA docket (Docket ID No. regulatory controls, as applied to the both RCRA permitting and NRC
RCRA–2001–0021; see ADDRESSES low-level mixed wastes (LLMW) it licensing requirements and regulatory
section of today’s preamble). generates and treats, provide any oversight from the point the waste is
additional environmental protection generated through to its final disposal.
III. Overview of the OMP Spring House than is otherwise provided by the Members of the regulated community
XL Pilot Project Atomic Energy Act (AEA) oversight, and have raised concerns that this dual
Today’s final rule will facilitate indeed believes that RCRA Subtitle C regulatory oversight of LLMW is unduly
implementation of the FPA that has regulatory controls serve as a major burdensome, duplicative and costly,
been developed by EPA, PADEP, the disincentive to environmentally without providing any additional
OMP Spring House facility, and other protective on-site treatment of the small protection of human health and the
stakeholders. Today’s final rule will volume of mixed wastes generated at the environment beyond that achieved
become effective under Pennsylvania facility. under one regulatory regime. In
State law in accordance with the While limited commercial off-site response to these concerns, on April 30,
Commonwealth’s hazardous waste treatment for such wastes is available, 2001, EPA Administrator Christine
program, as described further in section the on-site, bench-scale, high- Todd Whitman signed a final mixed
IV of this preamble. temperature catalytic oxidation unit waste rule modifying the existing
To implement this XL project, today’s OMP Spring House will use to treat the regulatory framework to provide
final rule provides a site-specific mixed wastes has been demonstrated to flexibility related to the storage,
exemption from the regulatory be more efficient in preventing the treatment (of certain types),
definition of hazardous waste for the emission of radioactivity to the transportation and disposal for LLMW
mixed wastes generated and treated in atmosphere and at least as efficient, if (see 66 FR 27217, May 16, 2001). This
OMP’s Spring House research and not more, at destroying the organic rule became effective on November 13,
development laboratory. The terms of components than available commercial 2001 (‘‘Mixed Waste Rule’’).
the overall XL project are contained in treatment. (The on-site treatment of In developing the Mixed Waste Rule,
an FPA which is included in the docket OMP Spring House’s mixed wastes has EPA assessed NRC regulations for
for today’s final rule. A draft version of been tested under a ‘‘treatability study’’ storage, treatment, transportation and
the FPA was the subject of a Notice of exemption provided in 40 CFR 261.4(f), disposal of low-level wastes (LLW) and
Availability published in the Federal and granted by PADEP.) According to compared them with EPA’s regulations
Register on September 1, 2000 in which OMP Spring House, it has not sought a for hazardous waste storage, treatment,
EPA solicited comment. The FPA was RCRA hazardous waste treatment permit transportation and disposal applicable
signed on September 22, 2000 by for the catalytic oxidation unit because to LLMW. The Agency found that given
representatives of EPA, the the costs of permitting cannot be NRC’s regulatory controls, protection of
Pennsylvania Department of justified from a business standpoint for human health and the environment
Environmental Protection (PADEP), and the small volume of LLMW generated. from chemical risks would not be
Ortho-McNeil Pharmaceutical. The Nor does OMP Spring House intend to compromised by deferral to NRC’s LLW
exemption from the regulatory become a commercial mixed waste management requirements under the
definition of hazardous waste of the treatment facility, receiving mixed circumstances set forth in the Mixed
mixed wastes generated at the OMP wastes from off-site facilities which Waste Rule. Accordingly, through the
Spring House facility will remain in might enable it to recover the costs of Mixed Waste Rule, the Agency adopted
effect only for the five-year term of this a RCRA permit. Finally, OMP Spring a conditional exemption from certain
XL project, and begins upon the House has asserted (as have many of RCRA hazardous waste management
effective date of this final rule. those who commented on EPA’s July, requirements for NRC-licensed
2001 proposed rule) that the costs of generators of LLMW, in specified
A. To Which Facilities Does the Final circumstances.
existing off-site commercial treatment
Rule Apply? Basically, the Mixed Waste Rule
for the small volume of mixed wastes
This final rule will apply only to the typically generated in the allows generators of LLMW to claim a
OMP Spring House facility. Thus, mixed pharmaceutical research industry are conditional exemption from the RCRA
wastes generated in other very high and therefore hinder the regulatory definition of hazardous waste
pharmaceutical research and research and development of new for mixed wastes stored, treated,
development facilities remain subject to pharmaceuticals. transported or disposed of under the
current Resource Conservation and NRC regulatory regime, acknowledging
Recovery Act (RCRA) Subtitle C 1. Current Regulatory Status of Mixed the protectiveness of NRC regulations
regulations. (The Agency notes that the Wastes for LLW (of which LLMW is a part). (For
term ‘‘RCRA Subtitle C regulations’’ Mixed waste comprises radioactive the complete text of the Mixed Waste
includes the exemptions and exclusions hazardous waste, subject to two Rule, see 66 FR 27217, May, 16, 2001.)
specific to mixed wastes that have been statutory authorities: (1) The RCRA as More specifically, the conditional
promulgated as part of the regulatory implemented by EPA (or States exemption allows, among other things,
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36852 Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Rules and Regulations
a generator to treat LLMW generated bench-scale high-temperature catalytic Rule because it is not conducted within
under a single NRC or NRC Agreement oxidizing unit and how it operates, the a ‘‘tank’’ or ‘‘container,’’ as those terms
State license, in tanks or containers, reader is referred to the July 24, 2001 are defined in RCRA. The Agency
without having to obtain a RCRA proposed rule (see 66 FR at 38399). For determined that more specific controls
treatment permit, provided the form of a more complete technical description (as are presently provided under RCRA)
treatment is allowed under its NRC or of the unit, operations parameters and are generally more appropriate for
NRC Agreement State license. The analytical methodology, the reader is certain forms of treatment, such as
conditional exemption for storage and referred to the document titled ‘‘A thermal treatment (including
treatment is only available to generators Prototype High-Temperature Catalytic incineration) which take place outside
of LLMW that are licensed by the NRC Oxidation Process For Mixed Waste In of a ‘‘tank’’ or ‘‘container,’’ due to the
or NRC Agreement States. In addition, A Pharmaceutical Research Laboratory,’’ complexity and variety of such
the Mixed Waste Rule provides that available in the docket for today’s final processes and the specificity of RCRA
LLMW that meets the applicable Land rule under Docket ID No. RCRA–2001– requirements. This XL pilot project
Disposal Restrictions (LDR) standards 0021.] affords the Agency an opportunity to
(either as generated or through OMP Spring House’s treatment of test whether a defined subset of LLMW
treatment) may be transported and carbon-14 labeled compounds generates (e.g., small volumes of research and
disposed of as LLW at an NRC or NRC radioactive CO2 (which is subsequently development laboratory-generated
Agreement State licensed low-level converted to potassium carbonate) and mixed wastes being treated within the
radioactive waste disposal facility the treatment of tritium labeled
NRC-licensed laboratory in which the
(LLRWDF), which need not also possess compounds generates radioactive (i.e.,
wastes are generated) may safely be
a RCRA treatment, storage, or disposal tritiated) water (3H). These residual low-
treated outside of a tank or container
permit. level wastes could then be sent off-site
(e.g., use of a bench-scale high
for stabilization, recycling, or disposal
2. Site-Specific Considerations at the temperature catalytic oxidation process)
under NRC or NRC Agreement State
OMP Spring House Facility regulation. [The Agency notes that without RCRA regulatory controls (i.e.,
OMP Spring House conducts research because the treatment process yields a treatment permit pursuant to Subtitle
and development of pharmaceuticals/ one of two residuals from a variety of C of RCRA), instead relying on AEA
drugs at its Spring House, Pennsylvania LLMW, they are more amenable to regulations implemented by the NRC.
facility. As part of this work, OMP recycling (e.g., recovery of tritium). Thus, this pilot project is intended to
Spring House develops and utilizes However, recycling the small volumes assess the appropriateness of the dual
radiolabeled compounds to study the of residuals being generated at the OMP oversight (i.e., concurrent RCRA and
bioabsorption and metabolism of the Spring House facility is not currently AEA regulatory controls) exerted over
drugs, in compliance with Food and economically viable. OMP Spring House the small volumes of mixed wastes
Drug Administration (FDA) has been working to support efforts to generated and treated at this
requirements. The radiolabeled facilitate the recovery of radioactivity pharmaceutical research and
compounds typically consist of an from residuals like those it generates in development facility, and to
isotopically-labeled organic compound its high-temperature catalytic characterize those factors that could
and a solvent (the specific solvent varies oxidization process.] For tritium inform EPA’s decision whether mixed
with the research being conducted). The containing compounds, the volume of wastes generated and treated in similar
solvent is mixed with a radioisotope the treatment residual is generally the circumstances should also be exempted
(typically carbon-14 (14C) or tritium same volume as the wastestream being from the regulatory definition of
(3H)), yielding both the desired treated. For carbon-14 containing hazardous wastes (and thus, RCRA
radiolabeled compound, and a waste compounds, the volume of the treatment regulatory control) on a national basis
mixture that consists of radioactive residuals is generally slightly higher (in effect, deferring regulatory oversight
materials (over which NRC has than the volume of the original of these specific types of mixed wastes
jurisdiction) and a hazardous organic wastestream being treated. The yearly to NRC or NRC Agreement States). The
component (over which EPA has estimated volume of the treatment pilot project will also provide the
jurisdiction). This radioactive/ residuals generated by the high- Agency additional data regarding the
hazardous organic waste mixture is the temperature catalytic oxidation of performance of the on-site, bench-scale
LLMW that is the focus of this XL pilot LLMW at OMP Spring House is 50 liters high-temperature catalytic oxidation
project. The estimated volume of mixed per year, which is about the same as the unit used to treat the mixed wastes,
waste produced per batch by OMP volume of the original LLMW. which will also be considered as part of
Spring House ranges from less than 50 OMP Spring House has been any future determination regarding
milliliters to several liters, with an operating this innovative catalytic possible changes to the types of units
annual total volume of less than 50 oxidation process for the treatment of included in RCRA’s May 2001 Mixed
liters. the mixed wastes it generates since 1996 Waste Rule.
OMP Spring House has developed an under a ‘‘treatability study exemption’’
innovative bench-scale treatment approved by the PADEP, which is To date, OMP Spring House’s
process (using high-temperature authorized to carry out portions of the treatability study has yielded extremely
catalytic oxidization), which oxidizes RCRA hazardous waste program in positive results, demonstrating that the
the mixed waste, thereby destroying its Pennsylvania. This treatability study full range of organics used to produce
hazardous waste components (yielding has been conducted to evaluate the radiolabeled compounds are effectively
water and CO2 ) and capturing the performance of the catalytic oxidation eliminated (routinely achieving
radioactivity in the aqueous residuals or process on the organic component of destruction and removal efficiencies
as radioactive CO2. In this process the these mixed wastes and the capture of (DRE) of 99.999% to 99.99999%) by the
liquid LLMW is completely reacted with the radioactive components. high-temperature catalytic oxidation
oxygen or air at high temperature in the The treatment technology being process. The treatment process exceeds
presence of an oxidation catalyst. [For a employed by OMP Spring House is not Land Disposal Restricitons (LDR)
general physical description of the included under the 2001 Mixed Waste treatment standards for organics, and
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Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Rules and Regulations 36853
releases only negligible amounts of EPA and the PADEP agreed that that this regulatory mechanism is the
radioactivity11. applicability of OMP Spring House’s most efficient way to provide OMP
The catalytic oxidation unit is housed NRC license conditions was likely Spring House with the regulatory
in a laboratory fume hood within OMP sufficient to ensure that OMP Spring outcome it seeks and implement the XL
Spring House’s radiosynthesis House’s high-temperature catalytic pilot project.
laboratory suite. All seven fume hoods oxidation would be operated so as to be The site-specific exemption being
in the lab suite are connected to a protective of human health and the finalized today is conditioned on
dedicated stack for air emissions. This environment absent RCRA regulatory various reporting requirements intended
air pollution control system employs controls, and EPA determined that the to provide the Agency with the data
high efficiency particulate arresting most appropriate mechanism to confirm necessary to determine whether this XL
(HEPA) filtration to capture any fugitive this was by exempting OMP Spring pilot project is a success and obtain the
dusts or particulate matter. No other House’s LLMW from RCRA’s definition information to help it decide whether
pharmaceutical research operations, or of hazardous waste, as discussed below. the regulatory change should be
other processes performed at the facility ‘‘transferred’’ to the national program
D. What Regulatory Changes Are Being (which, if it occurs, would happen
are tied into this system. Air emissions Made To Implement This Project?
monitoring for radioactivity is through normal rulemaking procedures).
performed whenever the process is To allow for this XL project to be The specific conditions are further
operating. The monitoring is of the implemented, the Agency proposed on discussed in section III.I.
consolidated non-turbulent air stream July 24, 2001 to provide a site-specific
exemption in 40 CFR 261.4(b) (i.e., E. Why Is EPA Supporting This
within the ventilation system after the Approach To Removing RCRA
juncture of the seven hoods and prior to ‘‘Solid wastes which are not hazardous
wastes’’) for the mixed wastes generated Regulatory Controls Over a Mixed
emissions into the atmosphere via the Waste?
dedicated stack. and treated in OMP Spring House’s
pharmaceutical research and The Agency agrees with OMP Spring
C. What Solution Is Being Tested by the development (R&D) laboratory (see 66 House that this XL project has merit and
OMP Spring House XL Project? FR 38396). The Agency is today has the potential to result in significant
OMP Spring House originally finalizing this site-specific rule, albeit environmental and efficiency benefits
proposed that EPA address its LLMW in clarifying that it comprises an should the regulatory change be adopted
one of three ways: exemption to RCRA’s definition of on a national basis. While the Agency
—Exempt the bench-scale treatment of hazardous waste, not an exclusion to adopted the Mixed Waste Rule to
mixed wastes from permitting RCRA’s definition of solid waste.2 The generically address the regulation of
requirements, effect of this exemption, assuming all some mixed wastes, Project XL offers
—Provide permit-by-rule exemptions for the conditions are met, is to remove the Agency the opportunity to test
the bench-scale treatment of mixed these wastes from RCRA Subtitle C alternative approaches, in this case, an
wastes, or regulation at the point of their alternative approach tailored to a
—De-list post-oxidation wastes pursuant generation. Further, because the specific subset of the generic category of
to 40 CFR 260.20 and 260.22 to allow residuals resulting from the catalytic mixed wastes not covered by the Mixed
the treatment of the LLMW. oxidation treatment process will not be Waste Rule. The Agency believes this is
Under each of these alternatives, OMP derived from hazardous wastes, no the type of ‘‘test’’ that Project XL is
Spring House noted that the laboratory ‘‘delisting’’ is required for these intended to facilitate. The information
in which the wastes are generated and residuals (since the original wastestream and data gathered throughout the course
treated would continue to be subject to will no longer comprise a RCRA of this XL project will provide the
an NRC license, which it believed ‘‘listed’’ waste). The Agency believes Agency with the ability to make a more
would be sufficient to protect human informed determination regarding the
health and the environment during the
2 In its July, 2001 proposal, EPA characterized the
appropriate regulatory controls for
regulatory flexibility to be offered under this XL ‘‘mixed waste’’ generally, as well as
generation and treatment of its LLMW, Project as comprising a
especially considering the very small ‘‘site specific exclusion in 40 CFR 261.4(b) (i.e.
certain discrete subsets of ‘‘mixed
volumes of wastes being generated and ‘Solid wastes which are not hazardous wastes’) for waste’’ that may be amenable to an
treated, the small size of the treatment the mixed wastes generated and treated in OMP alternative regulatory approach.
Spring House’s pharmaceutical research and
unit, the proximity of the treatment unit development (R&D) laboratory. The effect of this F. How Have Various Stakeholders Been
to the point of generation (the wastes are exclusion, assuming all the conditions are met, will Involved in This Project?
both generated and treated within the be to exclude these wastes from RCRA Subtitle C
same laboratory room), the sophisticated regulation at the point of generation, * * * Instead During the developmental stages of
of being considered ‘mixed wastes,’ these wastes this XL pilot project, OMP Spring House
level of expertise of the technicians that will simply be considered low-level wastes (LLWs)
work in the lab, and the protective subject to NRC or NRC Agreement State regulation.’’
cultivated stakeholder involvement
controls (e.g., emission limits) required 66 FR at 38400–01. from the local community and local
by the NRC license. EPA has determined that its use of the word environmental groups in a variety of
‘‘exclusion’’ (which generally applies to materials ways. These methods included
excluded from RCRA’s definition of solid waste communicating through the local news
1 During calendar year 2003, air emissions
under 40 CFR 261.4(a) rather than materials
monitoring revealed an annual average exempted from RCRA’s definition of hazardous media, announcements at Township
concentration of 7.54E–11 uCi/mL for tritium and waste under 40 CFR 261.4(b)), and the potential meetings, public meetings and direct
2.09E–11 uCi/mL for carbon-14 for all operations implication that this regulatory change would result contact with interested parties. For a
(i.e., not just emissions from the high-temperature in clarification. In this final rule, EPA makes plain
catalytic oxidation process). These annual average
that the effect of this regulatory change is to
concentrations of radionuclides in effluent air are conditionally exempt OMP Spring House’s LLMW methods used to involve stakeholders
less than 0.08% of the limits specified by NRC in from RCRA’s definition of hazardous waste under and the meetings held with the local
10 CFR Part 20 for allowable concentrations in 40 CFR 261.4(b) (and thus from its hazardous waste community to discuss the pilot project,
effluent air (i.e., 1 × 10E–7 mCi/mL for tritium and regulations). OMP Spring House’s LLMW remains
3 × 10E–7 uCi/mL for carbon-14 (present as carbon a solid waste under RCRA and thus, is subject to
the reader is referred to the July 24,
dioxide-14C)). Note that these units are expressed in EPA’s enforcement authority under Section 7001 of 2001 proposed rulemaking (see 66 FR at
microcuries (10 E–6 curies)/milliliter. RCRA. 38401).
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36854 Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Rules and Regulations
OMP Spring House understands that unit utilized by OMP Spring House $300,000/year cost for OMP Spring
stakeholder involvement is an integral meets or exceeds the existing treatment House, which generates up to 10 curies
part of the XL process and will continue standards that these wastes are subject of mixed waste per year. OMP Spring
to hold public meetings with the local to. Thus, we believe that the rule will House has stated that other cost savings,
community to provide updates and not pose additional risks to workers or such as reduced transportation costs
information on this XL pilot project, as the public. Moreover, the Agency notes and administrative/paperwork savings
needed. that since OMP Spring House’s waste resulting from no longer having its
stream will remain a solid waste under LLMW be defined as a RCRA hazardous
G. Response to Major Comments
RCRA, it retains the authority to require waste, are relatively minor compared
Received on the Proposed Rule
OMP Spring House to address any threat with the costs of commercial LLMW
The Agency received 65 comments in which it determines presents an treatment.
response to the July 24, 2001 proposed imminent threat to the public health or EPA understands that pharmaceutical,
rule. Detailed responses to all of these the environment. See 42 U.S.C. 6973(a). medical, and academic research
comments is presented in the document Further, a core goal of EPA’s XL activities, such as the radiolabeling
titled ‘‘Response to Comments on the initiative is to promote innovation, which generates OMP Spring House’s
OMP Spring House XL Project NPRM’’ which includes considering whether mixed wastes, are often limited by the
contained in the docket for today’s final new approaches are better able to high costs of waste management.
rulemaking under Docket ID No. RCRA– protect the public health and the Because waste management costs are
2001–0021. The vast majority of these environment than existing regulatory such a major factor in the budgets
comments were very supportive and requirements, even where the latter are allocated to such R&D activities, the
generally encouraged the Agency to long-established and required high cost of waste management can
move quickly to consider similar significant investment by facilities to significantly reduce the money actually
regulatory flexibility on a national scale. comply. Therefore, while EPA spent on R&D. With more cost-effective
However, two commenters submitted understands the concerns expressed by treatment (such as OMP Spring House’s
adverse comments, and several these commercial mixed waste on-site bench-scale catalytic oxidation
commenters provided editorial treatment facilities, the Agency does not unit), more money could be spent on the
suggestions and requests for believe that these concerns are sufficient actual research and development of
clarification. to preclude the exploration of other
The two commenters which opposed pharmaceuticals.
approaches or, in this specific case,
the proposed rule were both commercial testing the proposition that an NRC I. What Are the Terms of the OMP
LLMW treatment facilities, capable of license provides sufficient protections Spring House XL Project and How Will
treating OMP Spring House’s’s LLMW. for the thermal treatment of small They Be Enforced?
(EPA does note that several other volumes of research and development
treatment facilities offered comments To implement this XL pilot project,
LLMW in the same laboratory where the EPA is today modifying 40 CFR 261.4(b)
that were supportive of the proposal.) wastes are generated. (The Agency notes
These two commenters questioned the by providing a site-specific exemption
that these commenters did not suggest from the regulatory definition of
merits of reducing regulatory oversight any specific RCRA regulatory
for such wastes (with the potential for hazardous waste for OMP Spring
requirement that they thought is House’s LLMW generated and treated in
increased risks); the impact of such an necessary to protect human health and
exemption on the existing commercial their radiosynthesis laboratory, which is
the environment at OMP Spring House’s subject to a ‘‘Type A Broad Scope’’ NRC
mixed waste treatment industry (which NRC-licensed facility.)
has invested substantial resources to license for research and development. In
obtain the necessary permits and H. How Will This Project Result in Cost accordance with 25 Pa. Code section
licenses), and, (if the regulatory Savings and Paperwork Reduction? 261a.1 of Pennsylvania’s RCRA-
flexibility is adopted on a national scale OMP Spring House has stated that if authorized hazardous waste program,
for research and development it became required to obtain a RCRA EPA’s exemption of OMP Spring
laboratories) the advisability of having permit to operate its catalytic oxidation House’s mixed waste from the
many facilities generating radioactive unit, it would instead send its small regulatory definition of hazardous waste
residuals (even if they are small in volume of mixed wastes generated to a under RCRA is automatically
volume and recyclable) rather than a commercial treatment facility.3 For incorporated in Pennsylvania’s
small number of commercial facilities mixed wastes, commercial treatment hazardous waste regulations because the
generating such residuals (albeit in costs are typically based primarily upon State hazardous waste regulations
larger quantities). the level of radioactivity (i.e., number of incorporate 40 CFR 261.4(b) by
The Agency has considered the curies) being treated, as well as the reference, including any modification or
concerns expressed by these volume of the waste. The costs range additions made to that section by the
commenters; however, it believes this from approximately $20,000–$35,000 Federal program.
pilot project should go forward. The per curie, with an average cost of Through the development of the Final
Agency believes that the NRC license $30,000/curie. This represents a Project Agreement (FPA), OMP Spring
provides sufficient protections, at least House had agreed to comply with
in this specific situation, such that a 3 OMP Spring House believes that the current several conditions for this exemption,
RCRA permit is not necessary. Thus, we RCRA permitting requirements are intended to which were included in the regulatory
disagree with the commenter who apply primarily to commercial hazardous waste text that was proposed on July 24, 2001
treatment facilities, and that it would be difficult to
argues that the facility would be justify investing the costs of obtaining and
and are being finalized today. These
‘‘unlicensed/unpermitted.’’ We also maintaining a RCRA Subtitle C permit unless it conditions focus on demonstrating the
disagree with the commenter who could recoup such costs through commercial efficacy of the treatment technology,
suggested that this rulemaking would activities (i.e., treating wastes generated by other and to gather the data and other
generators for a fee). OMP Spring House has stated
reduce the treatment standards for this that it neither is nor intends to be in the commercial
information that will allow the Agency
waste. As has been demonstrated, the waste treatment business, and therefore it would to make a determination regarding the
high-temperature catalytic oxidation not seek such a permit. possible future adoption of this site-
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Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Rules and Regulations 36855
specific exemption as a nationwide J. How Long Will This Project Last and mixed waste was subject to RCRA after
generic exemption. When Will It Be Completed? Pennsylvania received its initial RCRA
The site-specific exemption is limited This project will be in effect for five base authorization (see 51 FR 24504,
to a total volume of 50 liters/year of years from the date that this final July 3, 1986), mixed waste was not
mixed waste and only applies to mixed rulemaking becomes effective, unless it initially included within Pennsylvania’s
wastes that are generated and treated is terminated earlier or extended by all authorized base program. Pennsylvania
using OMP Spring House’s high- project signatories (if the FPA and rule subsequently applied to EPA, seeking
temperature catalytic oxidation process are extended, this will be done through approval that its hazardous waste
within the OMP Spring House facility’s a rulemaking seeking the comments and program, as revised (including its
radiosynthesis laboratory. In addition, input of stakeholders and the public). adoption of regulations governing mixed
the exemption is further conditioned Any project signatory may terminate its waste), complied with RCRA. Under the
such that OMP Spring House must participation in this project at any time terms of the Commonwealth’s
report, on a semi-annual basis, the in accordance with the procedures set hazardous waste program, subsequent
following: forth in the FPA. The project will be modifications and additions to EPA’s
completed at the conclusion of the five- RCRA regulations as published in the
(1) Analysis demonstrating the Code of Federal Regulations (with
destruction and removal efficiencies for year anniversary of today’s final
rulemaking or at a time earlier or later certain exceptions not relevant here) are
all organic components of the exempted automatically incorporated into the
wastes subject to treatment. as agreed to by the parties involved.
Commonwealth’s hazardous waste
(2) Analysis demonstrating the IV. RCRA & Hazardous and Solid program. See 29 Pa. Bull. 2367, 2370
capture efficiencies for the radioactive Waste Amendments of 1984 (May 1, 1999), 65 FR at 57734 and
component of the exempted wastes A. Applicability of Rules in Authorized 57736 (September 26, 2000).
subject to treatment, and an estimate of States On September 26, 2000, EPA
the amount of radioactivity that was published notice of Final Authorization
released during the reporting period. Under section 3006 of RCRA, EPA of Pennsylvania’s hazardous waste
may authorize qualified States to program, including specifically its
(3) Analyses of the constituent administer and enforce the RCRA
concentrations, including inorganic regulation of mixed waste, effective
program for hazardous waste within the November 27, 2000. See 65 FR 57734
constituents, present and radioactivity State. (See 40 CFR Part 271 for the
of the exempted wastes prior to, and and 57736 (September 26, 2000). EPA
standards and requirements for did not receive any adverse comments,
after, treatment. authorization.) States with final and thus EPA’s authorization of
(4) The volume of exempted wastes authorization administer their own Pennsylvania’s hazardous waste
treated per batch, as well as a total for hazardous waste programs in lieu of the program (including mixed wastes)
the duration of the reporting period. Federal program. Following became effective on November 27, 2000.
(5) The final disposition of the authorization, a state continues to have This XL project was undertaken and
radioactive residuals from the treatment enforcement responsibility under its developed (by EPA, PADEP, and OMP
of the exempted wastes. State law to pursue violations of its Spring House) with the assumption that
In addition, OMP Spring House hazardous waste program. EPA Pennsylvania would receive
commits to work with other companies, continues to have independent authorization for mixed wastes,
organizations and research institutes to: enforcement authority under sections necessitating the regulatory flexibility
(1) Further develop a standard, bench- 3007, 3008, 3013 and 7003 of RCRA. on the part of PADEP to implement the
After authorization, Federal rules XL project. Since Pennsylvania has had
scale off-the-shelf treatment unit, based
issued under RCRA provisions that RCRA authorization for mixed wastes
on its high-temperature catalytic
predate the Hazardous and Solid Waste since November 27, 2000, and because
oxidation technology, to be made
Amendments of 1984 (HSWA), no Pennsylvania’s definition of hazardous
available to any company or institution
longer apply in the authorized state. waste under the Pennsylvania Solid
that generates similar R&D quantities of
New Federal requirements imposed by Waste Management Act (PaSWMA),
mixed wastes, and (2) further develop
non-HSWA rules do not take effect in an including its exclusions and
the technology and market for the
authorized State until the State adopts exemptions, incorporates RCRA’s
recycling and reuse of the radioactive
the requirements as State law. analogous provisions upon their
component of the LLMW (i.e., the LLW
In contrast, under section 3006(g) of
residuals resulting from the treatment of promulgation, this rule will have the
RCRA, new requirements and
the LLMW). effect of exempting OMP Spring House’s
prohibitions imposed by HSWA take
As part of meeting this commitment, mixed wastes from regulation by the
effect in authorized States at the same
OMP Spring House will prepare (and Commonwealth as a hazardous waste
time they take effect in nonauthorized
submit to EPA for review and comment) under its hazardous waste program,
States. EPA is directed to carry out
a proposed plan summarizing how it which in turn allows Pennsylvania to
HSWA requirements and prohibitions in
will accomplish this goal. Because these implement this XL project.
authorized States until the State is
two commitments involve the granted authorization to do so. V. Statutory and Executive Order
participation of other companies and Reviews
entities outside OMP Spring House’s B. Effect on Pennsylvania Authorization
control and thus are much less certain Today’s final rule is promulgated A. Executive Order 12866: Regulatory
than the conditions discussed above, pursuant to non-HSWA authority. Planning and Review
these commitments have not been made Pennsylvania initially received Under Executive Order 12866 (58 FR
conditions of the exemption. However, authority from EPA to implement its 51735), the Agency must determine
in evaluating the success of this XL base hazardous waste program effective whether this regulatory action is
project, these ‘‘non-enforceable’’ January 30, 1986 (see 51 FR 1791, ‘‘significant’’ and therefore subject to
commitments will be considered by January 15, 1986). Because EPA clarified formal review by the Office of
EPA and the PADEP. that the hazardous waste component of Management and Budget (OMB) and to
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36856 Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Rules and Regulations
the requirements of the Executive Order, C. Regulatory Flexibility Act costly, most cost-effective, or least
which include assessing the costs and Pursuant to the Regulatory Flexibility burdensome alternative if the
benefits anticipated as a result of this Act (5 U.S.C. 601 et seq., as amended by Administrator publishes with the final
regulatory action. The Order defines the Small Business Regulatory rule an explanation why that alternative
‘‘significant regulatory’’ action as one Enforcement Fairness Act (SBREFA) of was not adopted. Before EPA establishes
that is likely to result in a rule that may: 1996), whenever an Agency is required any regulatory requirements that may
(1) Have an annual effect on the to publish a notice for any proposed or significantly or uniquely affect small
economy of $100 million or more or final rule, it must prepare and make governments, including tribal
adversely affect in a material way the available for public comment a governments, it must have developed
economy, a sector of the economy, regulatory flexibility analysis that under section 203 of the UMRA a small
productivity, competition, jobs, the describes the effect of the rule on small government agency plan. The plan must
environment, public health or safety, or entities (i.e., small businesses, small provide for notifying potentially
State, local, or tribal governments or organizations, and small governmental affected small governments, enable
communities; (2) create a serious jurisdictions). However, no regulatory officials of affected small governments
inconsistency or otherwise interfere flexibility analysis is required if the to have meaningful and timely input in
with an action taken or planned by head of an agency certifies the rule will the development of EPA regulatory
another agency; (3) materially alter the not have a significant economic impact proposals with significant federal
budgetary impact of entitlements, on a substantial number of small intergovernmental mandates, and
grants, user fees, or loan programs or the entities. SBREFA amended the informing, educating, and advising
rights and obligations of recipients Regulatory Flexibility Act to require small governments on compliance with
thereof; or (4) raise novel legal or policy Federal agencies to provide a statement the regulatory requirements.
issues arising out of legal mandates, the of the factual basis for certifying that a As noted above, this rule is applicable
President’s priorities, or the principles rule will not have a significant only to one facility in Pennsylvania.
set forth in the Executive Order. economic impact on a substantial EPA has determined that this rule
Because this rule affects only one number of small entities. This rule will contains no regulatory requirements that
facility, it is not a rule of general not have a significant impact on a might significantly or uniquely affect
applicability and therefore is not subject substantial number of small entities small governments. EPA has also
to OMB review and Executive Order because it only affects the OMP Spring determined that this rule does not
12866. House facility, and it is not a small contain a Federal mandate that may
B. Paperwork Reduction Act entity. result in expenditures of $100 million or
Based on the foregoing discussion, I more for State, local, and tribal
This action does not impose an hereby certify that this rule will not governments, in the aggregate, or the
information collection burden under the have a significant adverse economic private sector in any one year. Thus,
provisions of the Paperwork Reduction impact on a substantial number of small today’s rule is not subject to the
Act, 44 U.S.C. 3501 et seq., since it entities. Consequently, the Agency has requirements of sections 202 and 205 of
applies to only one facility. It is exempt determined that preparation of a formal the UMRA.
from OMB review under the Paperwork Regulatory Flexibility Analysis is
Reduction Act because it is a site- unnecessary. E. Executive Order 13132: Federalism
specific rule, directed to fewer than ten
persons. 44 U.S.C. 3502(3), (10); 5 CFR D. Unfunded Mandates Reform Act Executive Order 13132, entitled
1320.3(c), 1320.4 and 1320.5. Title II of the Unfunded Mandates ‘‘Federalism’’ (64 FR 43255, August 10,
Burden means the total time, effort, or Reform Act of 1995 (UMRA), Public 1999), requires EPA to develop an
financial resources expended by persons Law 104–4, establishes requirements for accountable process to ensure
to generate, maintain, retain, or disclose federal agencies to assess the effects of meaningful and timely input by State
or provide information to or for a their regulatory actions on state, local, and local officials in the development of
Federal agency. This includes the time and tribal governments and the private regulatory policies that have federalism
needed to review instructions; develop, sector. Under section 202 of the UMRA, implications. ‘‘Policies that have
acquire, install, and utilize technology EPA generally must prepare a written federalism implications’’ is defined in
and systems for the purposes of statement, including a cost-benefit the Executive Order to include
collecting, validating, and verifying analysis, for proposed and final rules regulations that have ‘‘substantial direct
information, processing and with ‘‘federal mandates’’ that may result effects on the states, on the relationship
maintaining information, and disclosing in expenditures by state, local, and between the National Government and
and providing information; adjust the tribal governments, in the aggregate, or the states, or on the distribution of
existing ways to comply with any to the private sector, of $100 million or power and responsibilities among the
previously applicable instructions and more in any one year. various levels of government.’’
requirements; train personnel to be able Before promulgating a rule for which This rule does not have federalism
to respond to a collection of a written statement is needed, section implications. It will not have a
information; search data sources; 205 of the UMRA generally requires substantial direct effect on States, on the
complete and review the collection of EPA to identify and consider a relationship between the National
information; and transmit or otherwise reasonable number of regulatory Government and the States, or on the
disclose the information. alternatives and adopt the least costly, distribution of powers and
An agency may not conduct or most cost-effective or least burdensome responsibilities among the various
sponsor, and a person is not required to alternative that achieves the objectives levels of government, as specified in
respond to a collection of information of the rule. The provisions of section Executive Order 13132. Today’s rule
unless it displays a currently valid OMB 205 do not apply when they are will only affect one facility, providing
control number. The OMB control inconsistent with applicable law. regulatory flexibility applicable to this
numbers for EPA’s regulations in 40 Moreover, section 205 allows EPA to specific site. Thus, Executive Order
CFR are listed in 40 CFR part 9. adopt an alternative other than the least 13132 does not apply to this rule.
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Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Rules and Regulations 36857
F. Executive Order 13175: Consultation H. Executive Order 13211: Actions Today’s rule applies to one facility in
and Coordination With Indian Tribal Concerning Regulations That Pennsylvania. Overall, no
Governments Significantly Affect Energy Supply, disproportional impacts to minority or
Distribution, or Use low income communities are expected.
Executive Order 13175, entitled Today’s rule applies to one facility in
‘‘Consultation and Coordination with This rule is not a ‘‘significant energy
Pennsylvania. Overall, no
action’’ as defined in Executive Order
Indian Tribal Governments’’ (65 FR disproportional impacts to minority or
13211, ‘‘Actions Concerning Regulations
67249, November 6, 2000), requires EPA low income communities are expected.
That Significantly Affect Energy Supply,
to develop an accountable process to Distribution, or Use’’ (66 FR 28355, May K. Executive Order 12988: Civil Justice
ensure ‘‘meaningful and timely input by 22, 2001) because it is not likely to have Reform
tribal officials in the development of a significant adverse effect on the
regulatory policies that have tribal In issuing this rule, EPA has taken the
supply, distribution, or use of energy. It necessary steps to eliminate drafting
implications.’’ ‘‘Policies that have tribal will not result in increased energy
implications’’ is defined in the errors and ambiguity, minimize
prices, increased cost of energy potential litigation, and provide a clear
Executive Order to include regulations distribution, or an increased
that have ‘‘substantial direct effects on legal standard for affected conduct, as
dependence on foreign supplies of required by section 3 of Executive Order
one or more Indian tribes, on the energy. 12988, entitled Civil Justice Reform (61
I. National Technology Transfer and FR 4729, February 7, 1996).
Government and the Indian tribes, or on
Advancement Act of 1995 L. Congressional Review Act
the distribution of power and
responsibilities between the Federal Section 12(d) of the National The Congressional Review Act, 5
Government and Indian tribes.’’ Technology Transfer and Advancement U.S.C. 801 et seq., as added by the Small
Act of 1995 (‘‘NTTAA,’’ Public Law Business Regulatory Enforcement
This final rule, does not have tribal
104–113, section 12(d) (15 U.S.C. 272 Fairness Act of 1996, generally provides
implications. It will not have substantial
note) directs EPA to use voluntary that before a rule may take effect, the
direct effects on tribal governments, on consensus standards in its regulatory
the relationship between the Federal agency promulgating the rule must
activities unless to do so would be submit a rule report, which includes a
Government and Indian tribes, or on the inconsistent with applicable law or
distribution of power and copy of the rule, to each House of the
otherwise impractical. Voluntary Congress and to the Comptroller General
responsibilities between the Federal consensus standards are technical
Government and Indian tribes, as of the United States. Section 804
standards (e.g., materials specifications, exempts from section 801 the following
specified in Executive Order 13175. test methods, sampling procedures, and types of rules (1) rules of particular
EPA is currently unaware of any Indian business practices) that are developed or applicability; (2) rules relating to agency
tribes located in the vicinity of the adopted by voluntary consensus management or personnel; and (3) rules
facility. Thus, Executive Order 13175 standards bodies. The NTTAA directs of agency organization, procedure, or
does not apply to this rule. EPA to provide Congress, through OMB, practice that do not substantially affect
explanations when the Agency decides the rights or obligations of non-agency
G. Executive Order 13045: Protection of not to use available and applicable
Children From Environmental Health parties. EPA is not required to submit a
voluntary consensus standards. Today’s rule report regarding today’s action
Risks and Safety Risks rule does not establish technical under section 801 because this is a rule
Executive Order 13045, ‘‘Protection of standards. Therefore, EPA did not of particular applicability.
Children From Environmental Health consider the use of any voluntary
consensus standards. List of Subjects in 40 CFR Part 261
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997) applies to any rule that J. Executive Order 12898: Federal Environmental protection, Hazardous
EPA determines (1) is ‘‘economically Actions to Address Environmental materials, Waste treatment and disposal.
significant’’ as defined under Executive Justice in Minority Populations and Dated: June 20, 2005.
Order 12866, and (2) concerns an Low-Income Populations Stephen L. Johnson,
environmental health or safety risk that Executive Order 12898, ‘‘Federal Administrator.
EPA has reason to believe may have a Actions to Address Environmental ■ For the reasons set forth in the
disproportionate effect on children. If Justice in Minority Populations and preamble, title 40, chapter I of the Code
the regulatory action meets both criteria, Low-Income Populations’’ (February 11, of Federal Regulations is amended as
the Agency must evaluate the 1994) is designed to address the follows:
environmental health or safety effects of environmental and human health
the planned rule on children and conditions of minority and low-income PART 261—IDENTIFICATION AND
explain why the planned regulation is populations. EPA is committed to LISTING OF HAZARDOUS WASTE
preferable to other potential effective addressing environmental justice ■ 1. The authority citation for part 261
and reasonably feasible alternatives concerns and has assumed a leadership continues to read as follows:
considered by the Agency. role in environmental justice initiatives
to enhance environmental quality for all Authority: 42 U.S.C. 6905, 6912(a), 6921,
This rule is not subject to Executive 6922, 6924(y), and 6938.
citizens of the United States. The
Order 13045 because it is not an
Agency’s goals are to ensure that no Subpart A—General
economically significant rule as defined
segment of the population, regardless of
by Executive Order 12866, and because race, color, national origin, income, or
the Agency believes that the ■ 2. Section 261.4 is amended by adding
net worth bears disproportionately high paragraph (b)(17) to read as follows:
environmental health or safety risks and adverse human health and
addressed by this action do not present environmental impacts as a result of § 261.4 Exclusions.
a disproportionate risk to children. EPA’s policies, programs, and activities. * * * * *
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36858 Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Rules and Regulations
(b) * * * beginning six months after June 27, (D) Volume of the wastestream being
(17) Solid waste that would otherwise 2005, that must contain the following: treated per batch, as well as a total for
meet the definition of low-level mixed (A) Analysis demonstrating the the duration of the reporting period, and
wastes (LLMW) pursuant to § 266.210 of destruction and removal efficiency of (E) Final disposition of the radioactive
this chapter that is generated at the the treatment technology for all organic residuals from the treatment of the
Ortho-McNeil Pharmaceutical, Inc. components of the wastestream, wastestream.
(OMP Spring House) research and (B) Analysis demonstrating the (iii) OMP Spring House makes no
development facility in Spring House, capture efficiencies of the treatment significant changes to the design or
Pennsylvania and treated on-site using a technology for all radioactive operation of the high temperature
bench-scale high temperature catalytic components of the wastestream and an catalytic oxidation unit or the
oxidation unit is not a hazardous waste estimate of the amount of radioactivity wastestream.
provided that: released during the reporting period,
(i) The total volume of LLMW (C) Analysis (including (iv) This exclusion will remain in
generated and treated is no greater than concentrations of constituents, affect for 5 years from June 27, 2005.
50 liters/year, (ii) OMP Spring House including inorganic constituents, * * * * *
submits a written report to the EPA present and radioactivity) of the [FR Doc. 05–12658 Filed 6–24–05; 8:45 am]
Region III office once every six months wastestream prior to and after treatment, BILLING CODE 6560–50–P
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Documents Similar To Rule: Air programs; approval and promulgation; State plans for designated facilities and pollutants: Ortho-McNeil Pharmaceutical, Inc., facility, Spring House, PA
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