[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\
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\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