NCD980602163_19830121_Warren County PCB Landfill_SERB C_Guidelines for Applications for PCB Disposal Approvals for Biological Degredation Processes-OCR

GUIDELINES FOR APPLICATIONS FOR PCB DISPOSAL
APPROVALS FOR BIOLOGICAL DEGRADATION PROCESSES
(January 21, 1993)
The Environmental Protection Agency's (EPA's) approval program for the disposal of
Polychlorinated Biphenyls (PCBs) began with the passage of the Toxic Substances Control Act (TSCA)
in 1976. TSCA Section 6(e)(1)(A) requires EPA to prescribe methods for the disposal of PCBs. And,
except where specifically exempted, that disposal must be conducted under an approval Issued by EPA.
The final PCB disposal regulations are found in 40 CFR Part 761, Subpart D.
Section 761.60(e) of the existing PCB regulations provides for the approval of methods that are
alternatives to incineration for PCB destruction if they can achieve a level of performance equivalent to
Section 761. 70 incinerators or Section 761.60(a) (2) (iv) high efficiency boilers. Alternative methods that
use chemical, physical, alternate thermal, or biological treatments may be approved to destroy PCBs.
Alternate methods that are stationary and unique (site-specific design) are approved by the
Regional Administrator for the region where the facility is located. Alternate methods that are mobile or
that are to be located in more than one region and are not unique in design are approved by the
Director of the Chemical Management Division at EPA Headquarters in Washington, D.C.
In addition, EPA Regional Administrators have the approval authority for Research and
Development (R&D) into PCB disposal methods, regardless of type of method, that use 500 pounds or
less of total PCB-contaminated material. Disposal in any single experiment of more than 500 pounds of
total PCB or PCB-contaminated material for R&D purposes is approved by the Director of the Chemical
Management Division.
The flexibility of TSCA and its implementing regulations makes a systematic, organized approval
program for alternate methods of PCB destruction possible. Under TSCA, EPA issues two types of PCB
disposal approvals, the commercial operating approval and the Research and Development (R&D)
approval. If a technology is still experimental, like bioremediation, and has never been demonstrated
before, has had limited use, or has not been used on a field remediation scale to destroy PCBs, a
company may be asked to apply for an R&D approval to obtain data of known quality to properly
evaluate the technology.
Section 761.60(e) does not provide specific instructions concerning the type of information
required by EPA for the review of alternative disposal methods. However, a guidance document entitled
"Draft Guidelines for Permit Applications and Demonstration Test Plans for PCB Disposal by Non-
Thermal Alternative Methods" (August 21, 1986) is available from EPA. In addition, guidance documents
are available for use in formulating Quality Assurance plans associated with permit applications and
demonstration test plans.
This document, "Guidelines for Applications for PCB Disposal Approvals for Biological
Degradation Processes,· is not to be used alone, but is meant to be used in association with the other
documents. These Guidelines are adapted from the previous guidance document for non-thermal,
alternative methods, and they are designed specifically for applicants seeking EPA approval for R&D on
biological methods of PCB disposal.
Initial TSCA bioremediation approvals are considered more research than development because
it takes several years for a company to generate the data necessary for a proper evaluation by EPA of
any new process. As each technology becomes better understood and perfected, such experimental
and analytical detail probably will not be required. However, final approval of a bioremediation process
2
before It Is fully demonstrated risks bringing public disillusionment and discredit to the process.
When evaluating bloremediatlon processes, writers of TSCA approvals must draw upon the
experience of approving non-biological or engineered alternative disposal processes. The TSCA
approval program for all disposal technologies is based on perfonnance. The results of a successful
demonstration to EPA of a process determines the conditions under which the process will be allowed to
operate. However, It is hard to evaluate the perfonnance of a biological degradation process because
the process works so slowly and because the technology is so new that a strategy for decisively
demonstrating the biological degradation of PCBs In the environment ls not yet perfected.
At the present time because of all the uncertainties, EPA considers the R&D bioremediation
approval a well-designed scientific experiment to produce much needed data on the blodegradatlon of
PCBs. Headquarters R&D approvals for bloremediation are written for one year to provide for the study
of microbial degradation during one growing season and for the production of a report. The criteria and
process for a commercial operating demonstration and approval haven't yet been determined.
During the demonstration to EPA of the perfonnance of a mechanically engineered or non-
biological process, EPA requires that a company successfully destroy PCBs In three successive runs or
disposal treatments to obtain an approval to operate commercially. Since bloremediation requires an
extended period of time to be effective, the equivalent to the three treatment runs has not yet been
decided. However, whatever method or methods are chosen for evaluation of biological degradation
processes, they should be designed to show In which situations the process will be reliable. One
suggestion is that three years of successful R&D should be a requirement for a commercial operating
approval for a bioremediation PCB disposal process.
In addition, bioremediation will be successful in the environment at some PCB-contaminated
sites and not at others. For this reason, a bloremediation approval will always have a treatability study
component. There must be a central laboratory In which soil and sediment samples from a site being
considered for cleanup with a biodegradation process will be subjected to a specific testing protocol.
Then, once laboratory tests demonstrate the potential for microbial metabolism of PCBs under controlled
conditions, a biological process is ready for testing In field environments. However, from EPA's
experience, biodegradation processes that are successful in the laboratory don't always work well or
don't work at all in the field for a variety of reasons. And, even if a bioremediation process appears to
destroy PCBs in the field, data must show microbial involvement In the degradation process. To this
end, EPA requires that a company devise a validation strategy to demonstrate as unequivocally as
possible that biodegradation has taken place and that the PCB molecule has not been volatilized,
sorbed, transported, or attenuated by some other non-biological or •abiotic• reaction.
As part of such a validation strategy, EPA requires the use of a congener-specific method for
PCB analysis. Analytical methods used for commercial formulations or mixtures of PCBs, such as
Aroclors, are not acceptable because their use can mask congener-specific.or chemical-specific
degradation.
PCB analysis is complicated because there are 209 possible congeners or different chemicals in
the class of organic compounds known as polychlorinated biphenyls. They differ In the number and
position of chlorines on the basic biphenyl molecule.
The analytical method must be capable of separately quantltating each congener because, In the
microbial degradation process, each of these congeners differ In their susceptibility to breakdown.
Some PCB congeners are more easily biodegraded than others, depending on the number and position
of the chlorines on the blphenyl molecule.
..
3
In addition to a suitable analytical method, EPA requires several kinds of corroborating data
demonstrating biodegradation at a PCB-contaminated site. Such sources might include rough mass
balances assembled from site data showing that biological losses of PCBs exceeded expected abiotic or
non-biological losses, the presence of characteristic PCB metabolites, decreasing ratios of
biodegradable to non-biodegradable PCB congeners, and the presence of metabolically adapted
microbes in laboratory assays with environmental samples collected from a contaminated site. Currently
an applicant can propose any strategy for validating biodegradation and EPA will evaluate it because at
this time there is no standardized validation strategy.
Once rigorous R&D has shown that a company's process effectively biodegrades PCBs in
spatially separated, heterogeneous field sites, the company may apply for a TSCA Headquarters
approval to operate their process commercially anywhere in the country. To approve a bioremec:liation
process, EPA must make the finding that the process is equivalent to incineration in its ability to destroy
PCBs, that it produces no toxic by-products or toxic emissions, and what level of risk any
microorganisms used as inoculum pose to human health or the environment. For purposes of
evaluation of the effectiveness of bioremediation, EPA considers destruction of PCBs to less than two
parts per million (ppm) per congener peak quantitated with an individual congener standard, such as the
DCMA (Dry Color Manufacturer's Association) standard, as opposed to a total Aroclor standard, as the
standard to achieve in the treated waste.
The PCB disposal permitting process begins when an application is submitted for EPA's
approval. The application for a commercial operating approval should describe how the PCB disposal
facility will be operated on a commercial scale. The R&D approval application must contain the same
types of information required for an operating approval application, but without the same level of detail.
Also, the application does not have a Demonstration Test Plan.
No application for a PCB disposal approval will be considered complete unless there is enough
written information submitted to allow EPA to make a judgement on the safety and risks of the process.
The application must provide EPA with enough written information to make a finding that the disposal
activity will not present an unreasonable risk of injury to human health or the environment.
The following information is required in any PCB disposal approval application for a biological
degradation process:
1. APPROVAL COVER AND TABLE OF CONTENTS (SELF-EXPLANATORY)
2. SUMMARY
This means a short presentation of the document's organization, a discussion of the theory of
the biological process proposed for use, and all pertinent background information.
3. PROJECT ORGANIZATION
The application should briefly describe the project organization for the bioremediation study and ·
should provide an organization chart identifying key individuals and their organizational responsibilities.
It is EPA's experience that having a qualified and adequate operating staff is the key to any successful
R&D or commercial activity. The approval application must indicate that all essential positions are
adequately staffed and that the individuals are qualified to carry out their duties.
4
4. DESCRIPTION OF PROCESS THEORY AND ENGINEERING
The EPA needs sufficient detail in the application to understand the actual mechanism(s) of the
biological treatment process and the facility operations. While only a theoretical discussion of the
mechanisms for the proposed R&D project may be possible, this is still an Important part of the
application. In addition, discussion of any associated process engineering must be provided, for
example, for the operation of a bioreactor or an in situ pilot facility. At a minimum, a good flow diagram
and a brief description of any associated process engineering is required.
5. WASTE DESCRIPTION AND SITE CHARACTERIZATION
What kind of waste will be treated by the process? Most often biological processes are used to
treat soils and sediments contaminated with PCBs and other constituents toxic to man and/or the
organisms proposed for study or use. If in the future the process is to be tested in situ for possible use
in remediation of a site, then site characterization data should be included that show, at a minimum, the
concentration of PCBs and other hazardous constituents in the samples, and the location at the site
from which the samples were taken. In addition, diagrams should be included showing the site
topography, proximity to existing structures, populations, or sensitive ecosystems, and the distribution
and concentration of PCBs. These factors are all important for the reviewer's evaluation of the
application.
6. EXPERIMENTAL DESIGN AND SAMPLING/MONITORING PROCEDURES
In the R&D permit application, the applicant proposes an overall experimental design to meet
objectives proposed for the study. In addition, the applicant proposes a sampling and monitoring plan
for evaluating the performance of a bioremediation process on a continuing basis. Determining the
timing and location for sampling activities is important, particularly for in situ studies. Inclusion of good
controls is also important. The experimental design must be adequate to produce data of the high
quality necessary to judge the efficacy of a biological process. This is particularly important for in situ
studies where the environment provides many variables that cannot be controlled but that must be
measured.
7. ANALYTICAL PROCEDURES FOR SAMPLES
Based on information in the permit application, EPA must determine whether the analytical
metbods proposed by the applicant are acceptable for the needs associated with the particular facility
and "process. When the disposal process is destructive, as is the situation with biological processes,
samples containing residual PCBs must be analyzed with an individual congener quantification method
that uses Gas Chromatography. Analytical methods for total Aroclors are not acceptable because their
use could mask congener-specific degradation.
Methods must also be included in the approval application for any other tests, such as toxicity
tests, that will be performed during the PCB biodegradation study. Before any site can be deregulated,
toxicity tests must be used to determine that no toxic products have been produced during the
operation of the biodegradation study. No standard toxicity tests have been approved by EPA for this
particular use and each applicant is free to propose their own method for evaluation by EPA.
If any analyses are subcontracted to other outside laboratories, for example analyses for PCB
concentration, these labs are subject to the same rigorous Quality Assurance and Quality Control
procedures as the applicant. Everything possible must be done by the lab carrying out any analyses to
5
ensure the integrity and high quality of the data produced, regardless of whether the data is obtained by
the applicant's laboratory or by another laboratory.
8. QUALITY ASSURANCE PLAN
The Quality Assurance Project Plan (QAPP) should serve as a guide to the performance
objectives and operation of all systems concerned with data collection, sampling and monitoring,
analysis, and data/process assessment. The EPA document ·interim Guidelines and Specifications for
Preparing Quality Assurance Project Plans• (QAMS-005/80) is a good source of information for
preparing a QAPP.
Sometimes the QAPP Is seen as redundant or superfluous to the accompanying documentation
in the approval application. However, the data measurement systems defined In the QAPP will be used
In writing the conditions of any commercial operating permit, and the measurement systems must be
legally defensible. The only support for the quality of the PCB treatment process and the defensibility of
the permit are the systems defined in the QAPP. For EPA to accept the applicant's data, a QAPP must
be developed, approved and scrupulously followed.
9. DATA REPORTING/RECORDKEEPING
In the approval application, the applicant explicitly states what data are to be recorded (including
units) and how the data records are to be maintained. The conditions of the R&D approval require
submission of brief, quarterly progress reports to EPA. In addition, a final report Is required to be
submitted to EPA at the end of the study in which the data obtained is compiled in an organized fashion
to show results and trends.
In addition, in the event that the applicant's biological degradation process succeeds in lowering
the PCB concentration in soils and sediments or some other matrix, it is the responsibility of the
applicant to propose a strategy for evaluating the process and demonstrating that the agent of PCB
destruction was biological and not abiotic or non-biological. Data from preliminary studies should be
used to design a validation strategy for use in subsequent studies demonstrating
biodegradation. This does not have to be done for initial R&D work.
10. WASTE HANDLING AND DISPOSAL
The approval application must identify any potential by-product wastes (both PCB and non-PCB)
that might be generated; the amount of waste and factors influencing the volume of waste; and how the
wastes will be disposed of. In this section, the primary concern is regulatory compliance and
environmental protection. A treatment process is not serving a useful purpose if It is producing
hazardous by-products, materials that are similar to PCBs, or dispersing PCBs into the environment via
dilution, emissions, effluents, and hazardous residues (i.e., substituting one environmental hazard for
another).
Any wastes, except aqueous wastes, produced by a PCB disposal process that contain a
concentration (not resulting from dilution) of 2 ppm or greater of PCBs, will be treated as If they
contained the original PCB concentration and will be subject to TSCA disposal requirements. The
concentration of PCBs in aqueous wastes (not resulting from dilution) must be below 3 ppb after
treatment, or they must be handled as if they contained the original PCB concentration.
In the application, the applicant must provide specific details on waste handling methods,
including storage procedures and the arrangements for ultimate disposal of the wastes. Handling
procedures also involve spill control and worker safety considerations (i.e., protective clothing and
6
equipment). In addition, the final report submitted to EPA at the end of the study must contain
certificates of destruction or other documentation that waste used in the study was properly disposed.
11. INSPECTION PROCEDURES
The approval application must contain a discussion of routine inspection procedures used to
Identify problems and malfunctions associated with the facility or process.
12. SAFETY PLAN
The applicant should submit for EPA review the safety plan that will be initiated to protect
workers and .others from PCB exposure or other health hazards. The application must Identify specific
procedures in the safety program for ensuring safe routine operations (e.g., protective clothing); for
preventing worker /population exposure in the case of an equipment malfunction; for personnel
monitoring (including periodic physical examinations); and for shutting down or terminating the process
or degradation and controlling emissions in the event of a malfunction or environmental release. The
safety program should address provisions for prevention and control of fires, explosions, electrical
outages, etc., when applicable.
In addition, provisions for securing the test site and restricting public access must be addressed
(e.g., installation of fences, alarm systems, etc.).
13. TRAINING PLAN
The approval application should include a description of the training program to be initiated to
assure workers are trained in the overall requirements of their jobs, such as how to operate equipment,
use protective clothing, and properly handle and dispose of wastes.
14. SPILL PREVENTION CONTROL AND COUNTERMEASURES PLAN
This section is not always relevant to biodegradation processes that are primarily used for
cleanup of existing PCB spills to soils and sediments.
15. CLOSURE AND DECONTAMINATION PLAN
The closure plan must address items such as decontamination and disposal of equipment,
marking, labeling, and placarding of any contaminated equipment, and ultimate disposal of any wastes
generated from the study or from decontamination/cleanup procedures.
A closure plan is required for large scale, in situ facilities. Such detail is not necessary for
laboratory experiments, but an applicant must make provision for the proper disposal of waste used in
any permitted studies.
A decontamination plan must also be submitted for equipment that will not be disposed of at the
end of the study, such as laboratory equipment and bioreactors. The allowed residual PCB
concentration for impervious surfaces is 1 o micrograms per 100 square centimeters of surface area
using standard wipe sampling procedures on surfaces that have come into contact with PCBs during the
study.
•
7
16. OTHER PERMITS AND APPROVALS
In this section, the applicant should list other permits/approvals that have been obtained, are
being sought, or are required, and Identify the permitting agency and the person to contact for additional
Information.
17. STANDARD OPERATING PROCEDURES
Standard Operating Procedures (SOPs) should be detailed In the approval application. SOPs
are step-by-step procedures. For convenience, SOPs for labs should be separated from SOPs for
systems operations.
For laboratory SOPs, include details of chemical analytical methods proposed for use In
determining PCB concentrations. In addition, include details of any other test methods to be used, such
as toxicity tests.
18. TEST DATA FROM PREVIOUS EXPERIMENTS OR RELEVANT ARTICLES FROM
THE LITERATURE
19. BUSINESS CONFIDENTIALITY CLAIMS
Pursuant to the regulations at 40 CFR Part 2, Subpart B (41 Federal Register 36905, September
1, 1976, and 43 Federal Register 39997, September 8, 1978), an applicant is entitled to assert a business
confidentiality claim covering any information submitted as part of an application for a PCB disposal
approval. If such a confidentiality claim is not asserted with any submission, EPA may make this
information available to the public without further notice to the applicant.
20. THIRTY-DAY ADVANCE NOTIFICATION
Thirty-Day Advance Notification must be given of the R&D activity to other regulators of the site.
In addition, in some instances the general public must be notified as well.