


Economic Assessment of the PCB Extraction Methods and Amendments to PCB Cleanup and Disposal Regulations Proposed Rule



March 2021
Table of contents


EXECUTIVE SUMMARY

1. INTRODUCTION
Background  1
Need for Regulation  1
Report Organization  2

2. UPDATING PCB EXTRACTION METHODS 
Background  3
Summary of PCB Extraction Methods  3
Characterization of the Regulated Universe  6
Methodology and Results  8

3. UPDATING PCB DETERMINATIVE METHODS
Background  23
Identification of Facilities Affected by the Proposed Rule  23
Economic Impact  23

4. Proposed Revisions to § 761.61(B) 
Background  25
Proposed Changes  25
Characterization of the Regulated Universe  26
Methodology and Results  27

5. Removal of Regulatory Provision Allowing Disposal of PCB Bulk Product Waste as Roadbed
Methodology and Results  32

6. flexibilities for emergency situations
Background  34
Proposed Changes  35
Economic Assessment of Costs and Cost Savings  36

7. Harmonize General Disposal Requirements for PCB Remediation Waste
Background  39
Proposed Changes and Economic Impact  40

8. Net Economic Impacts of the Proposed Rule

9. Equity Considerations and Other Impacts
Regulatory Planning and Review  43
Regulatory Flexibility  43
Employment Impact Analysis  43
Unfunded Mandates  44
Federalism  44
Tribal Governments  44
Energy Impacts  44
Environmental Justice  45
Children's Health Protection  45
Joint Impacts of Rules  45
National Technology Transfer and Advancement Act  46






Executive Summary
Introduction
This document presents EPA's analysis of the costs, benefits, and economic impacts of the proposed rule to update the PCB extraction methods permissible under the Toxic Substances Control Act (TSCA) and amend several cleanup and disposal regulations. 
EPA is proposing the following provisions:
Expand allowable PCB extraction methods.  EPA is proposing to add EPA Method 3546 (Microwave Extraction), EPA Method 3545A (Pressurized Fluid Extraction), and EPA Method 3541 (Automated Soxhlet Extraction) to the list of allowable methods.  The methods allowed under the current regulations are EPA Method 3550B (Ultrasonic Extraction) and EPA Method 3540C (Manual Soxhlet Extraction (MSE).  
Remove ultrasonic extraction. EPA is also proposing to remove Method 3550B (Ultrasonic Extraction) from the PCB regulations.
Add PCB determinative methods. EPA is proposing to add additional methods to the list of permitted PCB determinative methods: SW-846 Methods 8082A and 8275A, and CWA Method 1668C. 
Amend performance-based disposal option under § 761.61(b). EPA is proposing to update the requirements for the performance-based disposal of PCBs. Changes include requiring recordkeeping and notification and allowing RCRA Subtitle C landfills as a disposal option. 
Remove regulatory provision allowing disposal of PCB bulk product waste as roadbed.  Due to concerns about contamination of adjacent media, EPA is proposing to prohibit the use of PCB bulk waste as a component of roadbed.
Add flexible provisions for emergency situations.  EPA is proposing to codify the flexibility previously provided case-by-case for performing PCB-related cleanups during emergencies and/or provide a waiver option to streamline the cleanup and disposal process.
Harmonize General Disposal Requirements for PCB Remediation Waste. EPA is proposing to amend § 761.50(b)(3)(ii) to remove a phrase that was added erroneously in 1998, which could be construed as producing inconsistency between this provision and other regulatory provisions and EPA guidance, including the existing definition of PCB remediation waste in § 761.3.  
Make changes to improve regulatory implementation. EPA is proposing a variety of supplemental amendments to improve implementation of existing requirements, clarify regulatory ambiguity, and correct technical errors and outdated information in the PCB regulations (e.g. updating mailing addresses). These changes are not expected to have any economic impact.
Impacts of Changes to PCB Extraction Methods
Universe
The proposed rule may potentially affect commercial laboratories that currently conduct PCB extractions under either of the currently permitted methods. EPA estimates that there are currently 22 labs that perform PCB extractions under TSCA using either of the two approved methods. EPA also estimates that there are 65,020 PCB extractions performed annually under TSCA.  EPA assumes that all labs currently conducting PCB extractions will convert to one of the three new methods and conduct the same number of tests annually.  Table ES-1 below summarizes the potentially impacted universe under the proposed provision.
Table ES-1.	potentially impacted universe Summary
                                Baseline Method
                                     Labs
                                  Extractions
Ultrasonic Extraction
                                      11
                                                                          3,023
Manual Soxhlet Extraction
                                      11
                                                                         61,997
Total
                                      22
                                                                         65,020
METHODOLOGY AND RESULTS
This Economic Assessment (EA) estimates the costs savings of the rule as the difference between affected facilities' baseline and policy-case (i.e., with the proposed rule) PCB extraction costs. This is consistent with guidance included in EPA's Guidelines for Performing Economic Analyses and OMB Circular A-4. This approach was designed specifically to estimate the cost impacts associated with laboratories switching from one of the currently approved PCB extraction methods to one of the methods newly approved in the proposed rule. To capture these impacts, this EA estimates two broad categories of costs: 
 One-time costs: For facilities switching to a new test method, these costs include: (1) purchasing new equipment, (2) training laboratory staff, and (3) completing the initial setup and testing of the new apparatus. 
 Annual cost savings: EPA anticipates that a laboratory switching to any of the three new test methods would realize cost savings for each extraction conducted. The annual cost savings related to the proposed rule include: (1) labor cost savings related to reduced extraction time, and (2) materials cost savings related to reduced material requirements to conduct extractions.
BASED ON THE CURRENT CERTIFICATIONS OF LABORATORIES THAT CURRENTLY CONDUCT TSCA PCB EXTRACTIONS, THIS EA ESTIMATES THE NUMBER OF LABORATORIES THAT SWITCH TO NEW METHODS. LABORATORIES ADOPTING A NEW METHOD WILL INCUR ONE-TIME COSTS RELATED TO INTEGRATING THE NEW METHOD INTO STANDARD PRACTICE, WHILE ALL LABORATORIES WILL REALIZE ANNUAL COST SAVINGS RELATED TO A REDUCTION IN TIME AND MATERIALS REQUIRED TO CONDUCT PCB EXTRACTIONS. TABLE ES-2 PRESENTS THE BASELINE AND POST-RULE DISTRIBUTION OF FACILITIES AND PCB EXTRACTIONS BY TEST METHOD.
Table ES-2.	Baseline and Proposed Rule Universe Distribution
                                Baseline Method
                             Proposed Rule Method
                                     Total
                                       
                             Microwave Extraction
                         Pressurized Fluid Extraction
                         Automated Soxhlet Extraction
                                       
                                       
                                     Labs
                                  Extractions
                                     Labs
                                  Extractions
                                     Labs
                                  Extractions
                                     Labs
                                  Extractions
Ultrasonic Extraction
                                       9
                                                                          2,473
                                       1
                                                                            275
                                       1
                                                                            275
                                      11
                                                                          3,023
Manual Soxhlet Extraction
                                       9
                                                                         50,720
                                       1
                                                                          5,636
                                       1
                                                                          5,636
                                      11
                                                                         62,000
Total
                                      18
                                                                         53,200
                                       2
                                                                          5,911
                                       2
                                                                          5,911
                                      22
                                                                         65,020

Based on the changes in test methods shown in Table ES-2 and the categories of costs discussed above, this EA estimates the annualized cost savings would be $4.2 million per year (see Table ES-3), assuming a seven percent discount rate. The majority of these cost savings result from a reduction in the annual labor and materials costs to laboratories that switch from conducting Manual Soxhlet Extractions to Microwave Extractions.
Table ES-3.	NET Cost Savings of PCB Extractions
                                Baseline Method
                               Net Cost Savings
                                       
                                       
                                       
                                  Annualized
                                 Present value
3 Percent Discount Rate
3550B Ultrasonic
                                                                        $58,380
                                                                       $899,500
3540C Manual Soxhlet
                                                                     $5,895,000
                                                                   $117,900,000
Total
                                                                     $5,954,000
                                                                   $118,800,000
7 Percent Discount Rate
3550B Ultrasonic
                                                                        $52,310
                                                                       $594,600
3540C Manual Soxhlet
                                                                     $4,196,000
                                                                    $83,930,000
Total
                                                                     $4,249,000
                                                                    $84,520,000

Impacts Related to Amending performance-based disposal under § 761.61(b)
Based on the proposed changes to § 761.61(b), this EA estimates annual cost savings of between $9.2 million and $10.9 million.  When discounted over a 20-year time period, this EA estimates cost savings of between $138 million and $162 million, assuming a three percent discount rate, and between $98 million and $116 million, assuming a seven percent discount rate.  The total impact of the updates to § 761.61(b) are shown in Table ES-4 below.
Table ES-4.	NET Cost Savings of § 761.61(b) Updates
                                 Cost Savings
                            3 Percent Discount Rate
                            7 Percent Discount Rate
                                       
                                      Low
                                     High
                                      Low
                                     High
Net Present Value
                                                                  $137,500,000 
                                                                  $162,400,000 
                                                                   $97,890,000 
                                                                  $115,600,000 
                                                                               
Annualized
                                                                     $9,240,000
                                                                    $10,910,000
                                                                     $9,240,000
                                                                    $10,910,000
Impacts related to the proposed removal of regulatory provision allowing disposal of pcb bulk product waste as roadbed
This economic assessment estimates that removing the option to allow PCB bulk product waste to be used as roadbed would result in an annual cost increase between $660 and $5,950. When discounted over a 20-year timeframe, this EA estimates the present value of the costs ranging from $9,800 to $88,500, assuming a three percent discount rate, and $7,000 to $63,000, assuming a seven percent discount rate. This increase in burden is necessary to prevent the potential migration of PCBs from roadbed to other media. The costs associated with this provision are presented in Table ES-5.
Table ES-5.	NET Cost Savings of removing the regulatory provision allowing disposal of pcb bulk prodct waste as roadbed
                                 Cost Savings
                            3 Percent Discount Rate
                            7 Percent Discount Rate
                                       
                                      Low
                                     High
                                      Low
                                     High
Net Present Value
                                                                       ($9,835)
                                                                      ($88,520)
                                                                       ($7,004)
                                                                      ($63,030)
Annualized
                                                                         ($661)
                                                                       ($5,950)
                                                                         ($661)
                                                                       ($5,950)
IMPACT of Other Rule Provisions
Based on the currently available data, EPA does not present any other quantifiable economic impacts to result from the other provisions summarized above.  Chapters 4, 5, and 7 describe the provisions in more detail and explain the potential economic impacts.
Net Impacts of the Proposed Rule
The total quantified cost savings of the proposed rule are estimated to be between $13.5 and $15.2 million, annualized, assuming a seven percent discount rate. This does not account for the cost savings related to adding flexibilities for emergency situations, which could not be quantified due to data limitations. A summary of the costs and cost savings of the proposed rule is presented in Table ES-6 below. 

Table ES-6.	NET Cost Savings of the Proposed Rule 
                            Proposed Rule Provision
                               Net Cost Savings
                                       
                                      Low
                                     High
                                       
                                  Annualized
                                 Present Value
                                  Annualized
                                 Present Value
3 PERCENT DISCOUNT RATE
PCB Extraction Methods
                                                                    $5,954,000 
                                                                  $118,800,000 
                                                                    $5,954,000 
                                                                  $118,800,000 
§ 761.61(b)
                                                                    $9,240,000 
                                                                  $137,500,000 
                                                                   $10,910,000 
                                                                  $162,400,000 
PCB BPW as Roadbed
                                                                         ($661)
                                                                       ($9,835)
                                                                       ($5,950)
                                                                      ($88,520)
Total
                                                                   $15,190,000 
                                                                  $256,300,000 
                                                                   $16,860,000 
                                                                  $281,100,000 
7 PERCENT DISCOUNT RATE
PCB Extraction Methods
                                                                    $4,249,000 
                                                                   $84,520,000 
                                                                    $4,249,000 
                                                                   $84,520,000 
§ 761.61(b)
                                                                    $9,240,000 
                                                                   $97,890,000 
                                                                   $10,910,000 
                                                                  $115,600,000 
PCB BPW as Roadbed
                                                                         ($661)
                                                                       ($7,004)
                                                                       ($5,950)
                                                                      ($63,030)
Total
                                                                   $13,490,000 
                                                                  $182,400,000 
                                                                   $15,160,000 
                                                                  $200,100,000 
Emergency Situations
                       Non-quantifiable net cost savings
Determinative Methods
                              No economic impact
§ 761.50(b)(3)
                              No economic impact
EQUITY CONSIDERATIONS AND OTHER IMPACTS
As required by applicable statutes and executive orders, this EA examines equity considerations and other regulatory concerns associated with the rule. Specifically, this EA considers the following: 
Regulatory planning and review: This action is not a "significant regulatory action" because it does not have a significant economic impact, nor does it raise novel legal or policy issues. The Office of Management and Budget (OMB) may waive review.  
Regulatory flexibility: EPA estimates that the proposed rule would not have significant economic impacts on a substantial number of small entities under the Regulatory Flexibility Act. 
Employment impacts: EPA expects that the rule may result in competing employment effects. The rule is likely to reduce expenditures on labor for PCB extraction testing, which may decrease employment, all else equal. However, the reduction in expenditures on PCB extraction testing may result in a marginal reduction in the prices charged by these firms for the goods and services that they produce. To the extent that prices charged by these firms decline, demand for their products may increase and they may therefore demand additional labor. It is unclear which of these two effects is more significant, but EPA expects the net employment impact of this rule to be negligible.
Unfunded mandates: Signed into law on March 22, 1995, the Unfunded Mandates Reform Act (UMRA) requires federal agencies, unless otherwise prohibited by law, to assess the effects of their regulatory actions on state, local, and tribal governments and on the private sector, to determine whether any final rulemaking may result in "any Federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year." Based on the magnitude of the final rule's estimated cost impacts, the rule is not estimated to result in annual expenditures exceeding $100 million for either the private sector or state, local, and tribal governments in the aggregate. 
Federalism: EPA estimates that the proposed rule would not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
Tribal governments: EPA estimates that the proposed rule would not impose a substantial burden on tribal governments.
Energy Impacts: The proposed rule is not expected to have a significant adverse effect on energy supply, distribution, or use. In addition, no measurable adverse impacts are expected on energy prices or foreign supplies.
Environmental justice: EPA does not expect that the proposed rule would result in disproportionately high or adverse impacts for minority or low-income populations. 
Children's health protection: The rule is not expected to result in a disproportionate adverse health impact on children. 
Joint impacts of rules: Some laboratories may already have the requisite equipment to conduct extractions under the methods proposed by the rule because of compliance with other EPA regulations.  In these cases, the laboratories would not need to purchase new equipment.
National Technology Transfer and Advancement Act: EPA is relying on voluntary consensus standards developed by ASTM and already in use in the laboratory testing sector, which is consistent with the National Technology Transfer and Advancement Act (NTTAA). Additionally, EPA has consulted with potentially impacted laboratories.




1. 	Introduction
Background
This document presents EPA's analysis of the costs, benefits, and economic impacts of the proposed rule to update the extraction methods used for Polychlorinated Biphenyls (PCBs) under the federal Toxic Substances Control Act (TSCA). Under the proposed rule, laboratories would be allowed to use three modern and affordable extraction methods that previously were not permitted (Automated Soxhlet Extraction - Method 3541, Microwave Extraction - Method 3545A, and Pressurized Fluid Extraction - Method 3546). Additionally, EPA is proposing that laboratories cease Ultrasonic Extraction (Method 3550B). In addition to updating the extraction methods, the proposed rule would expand the permissible determinative methods for PCBs, amend the performance-based disposal option under § 761.61(b), add flexibility to the PCB cleanup and disposal requirements during emergency situations, remove the option to dispose of PCB bulk product waste as roadbed, harmonize the general disposal requirements for PCB remediation waste, and make changes to improve regulatory implementation.
Need for Regulation
Extraction of PCBs from sample media using the methods allowed under current PCB regulations requires a significant amount of time and solvent. EPA has identified other extraction methods that are just as effective (if not more effective), require fewer labor hours, and less solvent per extraction. Using these extraction methods results in cost savings for the laboratories performing the extractions, while also decreasing the amount of spent solvent requiring disposal as regulated waste. This would allow for the market to determine which extraction methods laboratories choose to utilize.
EPA is adding new determinative methods for PCBs to provide laboratories with flexibility and to improve consistency with other EPA programs, such as the Resource Conservation and Recovery Act (RCRA). EPA is updating § 761.61(b) in order to gather basic information on sites that are remediated under this option and encourage efficient and thorough cleanups. The current TSCA regulations allow for PCB bulk product waste to be used as roadbed. However, EPA is proposing to disallow this practice because of the risk of PCBs migrating from roadbeds to adjacent environmental media. EPA is updating the general disposal requirements for PCB remediation waste, which could be construed as producing inconsistency between these provisions and other regulatory provisions and EPA guidance, including the existing definition of PCB remediation waste in § 761.3. The proposed rule also provides flexibility for cleanups during emergencies.  Finally, it includes other changes that are not expected to have any measurable economic impact (e.g., updating the regulatory language to be more gender inclusive).
Report Organization
EPA has prepared this economic assessment (EA) consistent with the requirements of Executive Order 12866, as amended by Executive Order 13563, and OMB Circular A-4. The bulk of this EA focuses on quantifying the costs and cost savings associated with updating the permissible PCB extraction methods. This EA first provides a summary of the existing and newly added extraction methods. Following this discussion, the EA estimates the number of impacted laboratories and number of extractions performed by those laboratories annually, based on publicly available laboratory accreditation databases and correspondence with commercial laboratories. Finally, this document estimates the costs and cost savings related to updating the extraction methods.
This report also includes economic assessments of the other provisions of the proposed rule, as summarized above. Chapter 2 discusses the updates to the PCB determinative methods, which are not expected to have any economic impact. This EA quantifies the costs and cost savings of the § 761.61(b) updates in Chapter 4. Chapter 5 contains a quantitative analysis of the costs associated with removing the provision allowing PCB bulk product waste to be used as roadbed. This is followed by a qualitative analysis of the cost savings related to adding flexibilities for emergency situations. The EA also includes a discussion of the revision to general disposal requirements for PCB remediation waste, which is not expected to have any economic impact. The penultimate chapter looks at the cumulative economic impact of all of the provisions in the proposed rule. Finally, this EA concludes by documenting equity considerations and other impacts related to the proposed rule.

2. 	Updating Extraction methods for PCBs Under the Toxic Substances Control Act
Background
One focus of this proposed rule is to ensure that laboratories are able to use the most modern, effective, and efficient methods and technologies for extracting PCBs under TSCA. This proposed rule would allow labs to use three new methods of extraction and would remove Ultrasonic Extraction (Method 3550B) from the list of allowable methods. EPA expects that most labs would utilize one of the three newly permitted methods because of the relative time and materials savings.
This section of the EA summarizes the relevant PCB extraction methods, identifies the universe of potentially affected facilities, and presents the methods and results of the economic analysis related to updating the extraction methods. This section focuses on updates to the extraction methods for solid matrices, as these changes are expected to produce an economic impact. It should be noted that the proposed rule also clarifies acceptable aqueous extraction methods (Method 3510C, Method 3520C, and Method 3535). However, since the regulations previously did not explicitly list acceptable liquid PCB extraction methods, EPA does not expect the addition of these methods would result in laboratories moving away from the existing methods used and would therefore have no economic impact.
Summary of PCB Extraction Methods
There are currently two methods for extracting PCBs that are accepted under the PCB regulations (40 CFR part 761). The proposed rule adds three new methods to the list of acceptable extraction methods and removes one of the current methods. This section of the EA provides a brief summary of each of these methods. The use of trade names or commercial products in this EA is for purposes of exposition only and does not constitute an EPA endorsement or exclusive recommendation for use. Each method summary is accompanied by one or more references that lead readers to a more in-depth explanation of the method.
EPA METHOD 3550B:  Ultrasonic Extraction
Ultrasonic Extraction is one of the two extraction methods currently permissible under TSCA. The proposed rulemaking proposes to discontinue use of this method for TSCA-related cleanup decisions. 
The exact method used depends on the expected concentration of organic compounds. Under the low concentration procedure, the sample is mixed with anhydrous sodium sulfate to form a free-flowing powder. The mixture is extracted with solvent three times, using ultrasonic extraction. The extract is separated from the sample by vacuum filtration or centrifugation. The extract is then ready for final concentration, cleanup, and/or analysis. Under the medium/high procedure, the sample is mixed with anhydrous sodium sulfate to form a free-flowing powder. This is extracted with solvent once, using ultrasonic extraction. A portion of the extract is then collected for cleanup and/or analysis.
Because of the limited contact time between the solvent and the sample, ultrasonic extraction may not be as rigorous as other extraction methods for soils/solids. Therefore, it is critical that the method (including the manufacturer's instructions) be followed explicitly, in order to achieve the maximum extraction efficiency. 
EPA Method 3540C: Soxhlet Extraction
Soxhlet extraction (manual Soxhlet extraction) is the primary PCB extraction method currently used under TSCA. Under the proposed rule, laboratories would be free to continue using this method. When performing a manual Soxhlet extraction, the solid sample is mixed with anhydrous sodium sulfate, placed in an extraction thimble or between two plugs of glass wool, and extracted using an appropriate solvent in a Soxhlet extractor. The extract is then dried, concentrated (if necessary), and, as necessary, exchanged into a solvent compatible with the cleanup or determinative step being employed. Manual Soxhlet extraction can take up to 24 hours to complete, which is much longer than other extraction methods.
EPA Method 3546: Microwave Extraction
TSCA does not currently list microwave extraction as a permissible method for PCB extractions. However, the proposed rule would make this method available. Both the extraction time and cost of equipment are relatively low for this method.  
IN A microwave extraction, samples are prepared for extraction by grinding them to a powder and loading them into the extraction vessel. The appropriate solvent system is added to the vessel and it is sealed. The extraction vessel containing the sample and solvent system is then heated to the extraction temperature and extracted for the amount of time recommended by the instrument manufacturer. After the mixture cools, the vessel is opened and the contents are filtered. The solid material is then rinsed and the various solvent fractions are combined. Finally, the extract may be concentrated, if necessary, and, as needed, exchanged into a solvent compatible with the cleanup or determinative procedure to be employed.
EPA Method 3545A: Pressurized Fluid Extraction (PFE)
Pressurized fluid extraction (PFE) is another extraction method that would become permissible for TSCA extractions under the proposed rule. PFE is sometimes referred to as accelerated solvent extraction, and a widely used commercial piece of equipment for PFE is called the Dionex[TM] ACETM 350. This extraction method is distinct from Automated Soxhlet Extraction (EPA Method 3541).
When performing a PFE, samples are prepared for extraction either by air drying the sample or by mixing the sample with anhydrous sodium sulfate or pelletized diatomaceous earth. The sample is then ground and loaded into an extraction cell. The extraction cell containing the sample is then heated to the extraction temperature, pressurized with the appropriate solvent system, and extracted for the period of time recommended by the instrument manufacturer. The solvent is then collected from the heated extraction vessel and allowed to cool. Finally, the extract may be concentrated, if necessary, and, as needed, exchanged into a solvent compatible with the cleanup or determinative step being employed.
EPA Method 3541: Automated Soxhlet Extraction
Automated Soxhlet extraction is the final PCB extraction method that the proposed rule would make permissible underthe PCB regulations. This method shares many similarities with manual Soxhlet extraction; however, it requires less time and solvent per sample. When performing an automated Soxhlet extraction, a moist solid sample (e.g., soil/sediment samples) may be air-dried and ground prior to extraction or chemically dried with anhydrous sodium sulfate. The prepared sample is then extracted using 1:1 acetone:hexane in the automated Soxhlet extraction system.
CHARACTERIZATION OF THE REGULATED UNIVERSE
The proposed rule to update the methods for extracting PCBs under TSCA may potentially affect any laboratory that currently performs such extractions. Additionally, the rule may also impact labs that currently perform extractions of PCBs using methods other than EPA Method 3540C (Manual Soxhlet Extraction) or EPA Method 3550B (Ultrasonic Extraction). These labs may decide to accept TSCA-related samples since they would be able to perform the extractions using equipment and methods with which they have experience.
The analysis of the rule estimates incremental costs that would be incurred on a per-facility basis (e.g., training) as well as incremental costs and cost savings that would be incurred on a per-test basis (e.g., labor time to conduct tests). To facilitate the estimation of all costs and cost savings associated with the proposed rule, this analysis estimates the number of facilities affected by the proposed rule and the number of TSCA PCB extractions conducted annually across the universe of facilities. The sections that follow present EPA's derivation of these estimates.
Identification of Facilities Affected by the Proposed Rule
The universe of facilities affected by the proposed updates to the PCB extraction methods are primarily commercial laboratories. To estimate the number of relevant laboratories, EPA relied on data from laboratory accreditation organizations and correspondence with lab personnel. This section discusses how EPA estimates the number of laboratories that would be affected by the proposed rule.
EPA anticipates that every facility that currently conducts TSCA PCB extractions (1) is compliant with the current test methods, (2) would no longer use manual Soxhlet extraction or ultrasonic extraction in favor of one of the less costly proposed methods, and (3) would continue to conduct PCB extractions. To the degree that facilities are not currently compliant or do not adopt the new method, this analysis may overestimate the number of facilities affected by the proposed rule. Additionally, EPA acknowledges that some laboratories that currently perform only non-TSCA PCB extractions may begin to accept TSCA PCB samples for extraction.
To identify the universe of commercial laboratories that may currently perform TSCA PCB extractions, EPA examined labs that are accredited to complete Method 3540C and/or Method 3550C. EPA searched for facilities using Method 3550C rather than 3550B, because it believes most labs actually use the most current method available. The NELAC Institute (TNI) is the main national organization that accredits labs in the US. TNI certifies 18 states and other independent organizations as accreditation bodies to accredit labs to the same national standard. This EA relies on the TNI National Environmental Laboratory Accreditation Management System (LAMS) database as the primary data source to estimate the number of commercial labs currently accredited to conduct PCB extractions. 
In addition to the database of accredited labs available directly from TNI LAMS, EPA also searched the individual accrediting body databases (if available), as well as two other states that accredit laboratories outside of TNI (California and Washington). While many of these labs were already documented as accredited in TNI LAMS, EPA identified 11 additional commercial labs accredited for either Method 3540C or 3550C from the American Association of Laboratory Accreditation (A2LA), the Louisiana Department of Environmental Quality, and the Pennsylvania Department of Environmental Protection. Combined with the accredited commercial labs shown in TNI LAMS, EPA identified 109 total commercial laboratories accredited to perform either Method 3540C or Method 3550C.
The result of analyzing all available databases indicated that a total of 109 laboratories are certified to perform Method 3540C and/or Method 3550C. However, it would be incorrect to assume that all of these labs use these methods to perform PCB extractions under TSCA, since the methods have multiple uses (e.g., extraction from food samples). In order to estimate the number of certified laboratories that perform PCB extractions under TSCA, EPA contacted commercial labs certified for the relevant methods. The number of laboratories that EPA was able to contact was limited by the Paperwork Reduction Act and the willingness of contacted laboratories to provide data. 
Overall, EPA received data from companies that represent 25 laboratories certified from Method 3540C and/or Method 3550C, or roughly 23% of the total certified labs. This correspondence revealed that only a total of 5 out of the 25 eligible labs currently perform PCB extractions under TSCA, or 20% of the eligible sample. Therefore, EPA estimates that 20% of the 109 certified labs currently perform relevant extractions, which is a total of approximately 22 laboratories.
Number of TSCA PCB Extractions Annually
TO ESTIMATE THE ECONOMIC IMPACTS OF THE PROPOSED RULE, IT IS NECESSARY TO KNOW HOW MANY TSCA PCB EXTRACTIONS ARE PERFORMED USING EITHER ULTRASONIC EXTRACTION OR MANUAL Soxhlet Extraction in the baseline scenario. EPA relied on communication with commercial laboratories to develop an estimate of the number of relevant extractions. Among the five labs that conduct PCB extractions under TSCA and provided data to EPA, a total of 19,703 extractions were performed per year using Method 3540C or Method 3550C. However, not all of those extractions were TSCA PCB extractions. One lab director estimated that 75% of the extractions are PCB extractions performed under TSCA. When extrapolated to the sample of 19,703 extractions, EPA estimates that 14,777 total extractions are performed under TSCA at the five labs providing data. When extrapolated to the larger universe of 22 facilities, EPA estimates that 65,020 PCB samples are extracted under TSCA each year. This information is summarized in Table 1.
Table 1.	Annual TSCA PCB Extractions 
                                    Method
                      Total Sample Extractions 
(5 labs)
                     TSCA PCB Sample Extractions 
(5 labs)
             Extrapolated Universe TSCA PCB Extractions 
(22 labs)
Ultrasonic Extraction (3550B)
                                                                            916
                                                                            687
                                                                          3,023
Manual Soxhlet (3540C)
                                                                         18,790
                                                                         14,090
                                                                         62,000
Total
                                                                         19,700
                                                                         14,780
                                                                         65,020

Methodology and Results
This section describes EPA's methodology for assessing the costs and cost savings of the proposed rule and presents the Agency's estimates of these impacts. In general terms, this methodology consists of three steps. First, EPA estimated the costs of conducting PCB extractions for facilities in the potentially regulated universe under the baseline (no rule) scenario. Next, the Agency estimated the costs to facilities in the potentially regulated universe under the proposed rule scenario. Finally, EPA estimated incremental costs (cost savings) of the proposed rule by comparing the estimated costs of conducting PCB extractions under the baseline and proposed rule scenarios.
Baseline Costs
To estimate baseline costs, EPA collected information on the unit costs of conducting PCB extractions under the existing PCB extraction methods: Method 3540C and Method 3550B. These unit costs were applied to all facilities in the potentially impacted universe.
Baseline Unit Costs
EPA developed baseline unit cost estimates from information collected through correspondence with EPA regional labs and commercial labs, as well as information collected from publicly available sources, such as vendors of solvents and other materials. Costs associated with conducting PCB extractions under the baseline scenario include labor and materials. Because PCB extractions are typically performed on a batch of samples rather than on individual samples, EPA calculated baseline unit costs for an extraction of 12 samples for the purposes of this analysis. Since some aspects of labor time do not scale linearly with the number of samples (e.g., it takes 1 sample the same amount of time to dry as it does 12 samples), assuming that samples are extracted in batches creates a more realistic model. A sample size of 12 was chosen because it represents one half of the maximum capacity of many PCB extraction systems. Table 2 presents the per-test unit costs for individual material and labor cost components.
Table 2.	Baseline Unit Costs (Year 2019$)
                                 Cost Feature
                           Unit Costs for Extraction
                                       
                              Ultrasonic (3550B)
                            Manual Soxhlet (3540C)
                                       
                           Quantity 
(ml or minutes)
                                   Cost ($)
                           Quantity 
(ml or minutes)
                                   Cost ($)
Materials (12 samples):
Solvent
                                                                       1,200 ml
                                                                           $43 
                                                                       3,600 ml
                                                                          $130 
Solvent Disposal
                                                                       1,200 ml
                                                                           $78 
                                                                       3,600 ml
                                                                          $233 
Labor (12 samples):
Setup time
                                                                         64 min
                                                                           $64 
                                                                         90 min
                                                                           $90 
Sample Prep Time
                                                                         60 min
                                                                           $60 
                                                                        150 min
                                                                          $150 
Active Extraction Time
                                                                         48 min
                                                                           $48 
                                                                        600 min
                                                                          $601 
Active Filter & Dry Time
                                                                          0 min
                                                                            $0 
                                                                         80 min
                                                                           $80 
Concentration Time
                                                                        340 min
                                                                          $341 
                                                                        634 min
                                                                          $635 
Total Labor per 12 samples
                                                                        512 min
                                                                          $513 
                                                                      1,554 min
                                                                        $1,557 
Total Cost per 12 Samples
                                                                               
                                                                          $634 
                                                                               
                                                                        $1,880 
Total Cost per Sample
                                                                               
                                                                            $53
                                                                               
                                                                           $157

Materials Costs
All of the relevant PCB extraction methods require a solvent; however, the amount of solvent used varies with the extraction method. In general, the solvent is composed of a 1-to-1 mixture of hexane and acetone. Manual Soxhlet extraction is known for requiring a large quantity of solvent. In this instance, for 12 samples MSE requires 3,600 ml of solvent, while ultrasonic extraction requires 1,200 ml. Each chemical can be purchased in a 4-liter bottle, with acetone costing $66.58 and hexane costing $223.[,] The average cost of acetone and hexane is $.04 per ml. This unit cost was multiplied by the quantity of solvent used for a 12-sample extraction to arrive at the solvent cost.
After the extraction is performed, the solvent needs to be disposed of safely and properly as a hazardous waste. It is estimated that the cost of disposal is $.06 per ml. This unit cost was also multiplied by the quantity of solvent used for a 12-sample extraction to arrive at the solvent disposal cost.
Labor Costs
Although each PCB extraction method is unique, there is overlap in the types of steps taken to perform the extraction. The steps that a chemist undertakes to perform a PCB extraction can broadly be broken down as setup, sample preparation, extraction, filter & dry, and extract concentration. The amount of time that each of these steps takes for a 12-sample extraction is estimated based on a comparison study conducted by chemists in EPA's Region 8 laboratory. 
EPA estimated that the hourly labor cost for the typical chemist performing this work would be $60 per hour (including benefits and overhead). This was calculated by taking the median wage rate for "chemists and material scientists" in NAICS code 541380 ($32.38) and applying a multiplier of 1.39 for fringe benefits and a multiplier of 1.336 for overhead.
It should be noted that while some steps in PCB extraction may require a certain amount of time, they do not demand the chemist to be working on the extraction for the entire period. For example, a chemist may check in on the sample regularly during the 20-hour-long extraction phase of a manual Soxhlet extraction, but they may also work on other projects. For this reason, an "active labor time" was calculated at a rate of 50 percent of the total time for the extraction phase and the filter & dry phase.  For other phases, active labor time is assumed to be 100 percent.
Estimation of Total Baseline Costs & Baseline Cost Results
To calculate the total costs of extracting PCBs under TSCA in the baseline scenario, EPA applied the total per-test costs to the number of extractions estimated previously in this EA. EPA applied a cost of $52.80 to every ultrasonic PCB extraction and $156.69 to every manual Soxhlet extraction. In the baseline scenario, there are no one-time costs, because all relevant laboratories already have the appropriate equipment and training. The total cost of performing PCB extractions under TSCA in the baseline scenario is approximately $9.87 million. Table 3 presents a breakdown of these baseline costs.
Table 3.	Baseline Cost Results
                                    Method
                          Total TSCA PCB Extractions
                                Cost per Sample
                                  Total Cost
Ultrasonic Extraction (3550B)
                                                                          3,023
                                                                            $53
                                                                       $159,600
Manual Soxhlet (3540C)
                                                                         62,000
                                                                           $157
                                                                     $9,714,000
Total
                                                                         65,020
                                                                              
                                                                     $9,874,000

Proposed Rule Costs
To estimate costs for the proposed rule scenario, EPA collected information on unit costs relevant to changes that would result at laboratories that may adopt one of the new extraction methods. 
Proposed Rule Unit Costs
For the proposed rule scenario, EPA developed unit cost estimates from information gathered through correspondence with laboratory personnel, as well as from information collected from publicly available sources. EPA divided the costs associated with conducting PCB extractions under the proposed rule scenario into three categories: (1) per-facility one-time costs, (2) materials costs per-extraction, and (3) labor costs per-extraction. EPA again based its unit costs on a 12-sample extraction. Table 4 presents the unit costs for each of these categories.
TABLE 4.	Proposed Rule Unit Costs (Year 2019$)
                                 Cost Feature
                               Microwave (3546)
                           Pressurized Fluid (3545A)
                           Automated Soxhlet (3541)
                                       
                                   Quantity
                                   Cost ($)
                                   Quantity
                                   Cost ($)
                                   Quantity
                                   Cost ($)
One-Time Costs: 
Equipment
                                                                               
                                                                        $30,000
                                                                               
                                                                        $40,000
                                                                               
                                                                      $ 126,500
Training
                                                                        480 min
                                                                           $481
                                                                        480 min
                                                                           $481
                                                                        480 min
                                                                           $481
Develop IDC/MDL
                                                                        960 min
                                                                           $962
                                                                        960 min
                                                                           $962
                                                                        960 min
                                                                           $962
Total One-Time Costs
                                                                               
                                                                        $31,443
                                                                               
                                                                        $41,443
                                                                               
                                                                       $127,943
Materials per Extraction (per 12 samples per extraction):
Solvent
                                                                         300 ml
                                                                            $11
                                                                         792 ml
                                                                            $29
                                                                         600 ml
                                                                            $22
Solvent Disposal
                                                                         300 ml
                                                                            $19
                                                                         792 ml
                                                                            $51
                                                                         600 ml
                                                                            $39
Hydromatrix
                                                                          120 g
                                                                            $26
                                                                          120 g
                                                                            $26
                                                                          120 g
                                                                            $26
Stir Bars
                                                                        12 bars
                                                                            $15
                                                                               
                                                                               
                                                                               
                                                                               
Boiling Stones
                                                                               
                                                                               
                                                                               
                                                                               
                                                                      12 stones
                                                                             $2
Cellulose Filters
                                                                               
                                                                               
                                                                     12 filters
                                                                             $5
                                                                               
                                                                               
Labor per Extraction (minutes, 12 samples per extraction):
Setup Time
                                                                         30 min
                                                                            $30
                                                                         50 min
                                                                            $50
                                                                         44 min
                                                                            $44
Sample Prep Time
                                                                         66 min
                                                                            $66
                                                                         80 min
                                                                            $80
                                                                         70 min
                                                                            $70
Active Extraction Time
                                                                         11 min
                                                                            $11
                                                                        140 min
                                                                           $140
                                                                       72.5 min
                                                                            $73
Active Filter & Dry Time
                                                                         75 min
                                                                            $75
                                                                         40 min
                                                                            $40
                                                                         40 min
                                                                            $40
Concentration Time
                                                                         66 min
                                                                            $66
                                                                         54 min
                                                                            $54
                                                                        120 min
                                                                           $120
Total Extraction Labor (12 samples)
                                                                        248 min
                                                                           $249
                                                                        364 min
                                                                           $365
                                                                        347 min
                                                                           $347
Total Extraction Labor and Material Cost (12 samples)[1]
                                                                               
                                                                           $320
                                                                               
                                                                           $476
                                                                               
                                                                           $436
Total Extraction Labor and Material Cost per Sample[1]
                                                                               
                                                                            $26
                                                                               
                                                                            $40
                                                                               
                                                                            $36
Notes:
1. Values in this row do not reflect one-time costs presented above in this table.

Per-Facility One-Time Costs
Laboratories that previously had the equipment and trained personnel to perform only manual Soxhlet extractions or ultrasonic extractions would incur a number of one-time costs associated with applying a new extraction method for PCBs. Each of the three methods that would be newly allowed under the proposed rule requires a piece of machinery. The microwave used for EPA Method 3546 costs an estimated $30,000. The equipment used for pressurized fluid extraction, such as the ASE[TM] 350, can cost $40,000. Finally, the equipment for performing automated Soxhlet extractions costs approximately $126,500 (including multi-stack controllers, connectors, and a chilling recirculator). The unit costs are all based on the required equipment to perform an extraction of 24 samples.
In addition to purchasing new equipment, laboratories need to train their personnel to perform the new extraction methods. In many cases, the company that a lab purchased a machine from will send an individual to the lab for one day to provide guidance on the machine. It is estimated that it would take a chemist 8 hours to become trained for each method. It is also expected that it would take a chemist 8 hours to develop an initial demonstration of capability (IDC) for the method and an additional 8 hours to establish a method detection limit (MDL).
It should be noted that many laboratories that currently perform TSCA PCB extractions using Method 3550B or 3540C already have the equipment and capability to perform one or more of the other extraction methods. These methods are often used for PCB extractions related to RCRA or to extract other organic compounds. Labs that already apply one of these methods would not experience any one-time costs due to the proposed rule.
Per-Extraction Materials Costs
Similar to the baseline methods, the three extraction methods allowed by the proposed rule all use a hexane-acetone mixture as a solvent. All three of these methods use less solvent on a per-12-sample basis than the baseline methods. This results in lower costs for both purchasing and disposing of solvent. Additionally, all three methods require roughly 10 grams of hydromatrix per sample (120 grams per-12-samples). The hydromatrix costs roughly $219 per kilogram and is used to dry samples.
Each of these three extraction methods also requires an additional unique material. The microwave extraction method requires a stir bar for each sample. The stir bars cost roughly $126 for a pack of 100. Automated Soxhlet extraction requires boiling stones, which cost approximately $1.60 for each 12 sample extraction. Finally, pressurized fluid extraction requires a cellulose filter for each sample, which costs approximately $44.48 for a pack of 100.
Per-Extraction Labor Costs
The per-extraction labor costs for the proposed rule scenario were calculated in a similar manner to those in the baseline scenario. Similar to the reduced solvent use associated with the proposed rule methods, each of the three newly approved methods requires less time to perform per test, with microwave extraction taking the least time overall. Table 5 shows the estimated labor time per test.
Proposed Rule Cost Estimation Methodology
In order to estimate the costs under the proposed rule scenario, EPA first established an estimate of how many labs would use each of the three newly allowed methods and how many extractions would be performed using each method. EPA then applied the appropriate one-time costs and per-extraction costs to get an estimate of the total costs.
Proposed Rule Cost Results
The first step in establishing costs under the proposed rule scenario was identifying which methods labs would utilize. To make this determination, EPA first categorized laboratories based on the certifications they had for the five relevant methods (the two currently allowed methods and the three new methods). Each of the 109 labs fell into one of 22 combinations of certifications. EPA assumed that a facility used manual Soxhlet extraction in the baseline scenario if they were certified for both manual Soxhlet extraction and ultrasonic extraction. This assumption is based on the fact that there were far more extractions using manual Soxhlet extraction in the sample laboratories. Based on the lower per-extraction costs, EPA also assumed that all laboratories would transition to using one of the new methods offered. If a facility is currently certified for any of the three new methods, this analysis assumes that they would use that method in order to avoid one-time costs, such as purchasing new equipment. If a lab was not already certified for any of the new methods, it was assumed that they would purchase the equipment necessary to conduct PCB extractions using microwave extraction and use Method 3546 based on its lower costs relative to the other methods. EPA applied a factor of 20% to the total number of labs in each category to derive the extrapolated number of relevant labs. This factor was based on the number of responding labs performing PCB TSCA extractions (5) and the total number of labs represented by responding companies (25). Table 5 presents a detailed breakdown of all of the laboratory categories and Table 6 presents a simplified version of how many labs utilize each method in the post-rule scenario.
Table 5.	Detailed Breakdown of Laboratory Certifications and Methods
                          Current Lab Certifications
                                Baseline Method
                             Proposed Rule Method
                                   # of Labs
                            Extrapolated # of Labs
                        3540C
Manual Soxhlet Extraction
                          3550
Ultrasonic Extraction
                       3541
Automated Soxhlet Extraction
                      3545A Pressurized Fluid Extraction
                           3546
Microwave Extraction
                                       
                                       
                                       
                                       
                                       
                                       P
                                       
                                       
                                       
Ultrasonic
Microwave
                                                                             31
                                                                           6.20
                                       
                                       P
                                       
                                       
                                       P
Ultrasonic
Microwave
                                                                              9
                                                                           1.80
                                       
                                       P
                                       
                                       P
                                       
Ultrasonic
Pressurized Fluid Extraction
                                                                              3
                                                                           0.60
                                       
                                       P
                                       
                                       P
                                       P
Ultrasonic
Microwave
                                                                              2
                                                                           0.40
                                       
                                       P
                                       P
                                       
                                       
Ultrasonic
Automated Soxhlet Extraction
                                                                              3
                                                                           0.60
                                       
                                       P
                                       P
                                       
                                       P
Ultrasonic
Pressurized Fluid Extraction
                                                                              4
                                                                           0.80
                                       
                                       P
                                       P
                                       P
                                       
Ultrasonic
Automated Soxhlet Extraction
                                                                              1
                                                                           0.20
                                       P
                                       
                                       
                                       
                                       
Manual Soxhlet
Microwave
                                                                             11
                                                                           2.20
                                       P
                                       
                                       
                                       
                                       P
Manual Soxhlet
Microwave
                                                                              3
                                                                           0.60
                                       P
                                       
                                       
                                       P
                                       
Manual Soxhlet
Pressurized Fluid Extraction
                                                                              3
                                                                           0.60
                                       P
                                       
                                       
                                       P
                                       P
Manual Soxhlet
Microwave
                                                                              1
                                                                           0.20
                                       P
                                       
                                       P
                                       
                                       
Manual Soxhlet
Automated Soxhlet Extraction
                                                                              2
                                                                           0.40
                                       P
                                       
                                       P
                                       
                                       P
Manual Soxhlet
Microwave
                                                                              1
                                                                           0.20
                                       P
                                       
                                       P
                                       P
                                       
Manual Soxhlet
Automated Soxhlet Extraction
                                                                              1
                                                                           0.20
                                       P
                                       P
                                       
                                       
                                       
Manual Soxhlet
Microwave
                                                                              8
                                                                           1.60
                                       P
                                       P
                                       
                                       
                                       P
Manual Soxhlet
Microwave
                                                                             16
                                                                           3.20
                                       P
                                       P
                                       
                                       P
                                       
Manual Soxhlet
Pressurized Fluid Extraction
                                                                              3
                                                                           0.60
                                       P
                                       P
                                       
                                       P
                                       P
Manual Soxhlet
Microwave
                                                                              1
                                                                           0.20
                                       P
                                       P
                                       P
                                       
                                       
Manual Soxhlet
Automated Soxhlet Extraction
                                                                              1
                                                                           0.20
                                       P
                                       P
                                       P
                                       
                                       P
Manual Soxhlet
Microwave
                                                                              4
                                                                           0.80
                                       P
                                       P
                                       P
                                       P
                                       
Manual Soxhlet
Automated Soxhlet Extraction
                                                                              1
                                                                           0.20
                                       P
                                       P
                                       P
                                       P
                                       P
Manual Soxhlet
Microwave
                                                                              1
                                                                           0.20


Table 6.	Number of Laboratories by Proposed Rule Method
                                    Method
                            Extrapolated # of Labs
Automated Soxhlet
                                       2
Pressurized Fluid
                                       2
Microwave
                                      18

In addition to the number of laboratories that would perform each type of extraction in the proposed rule scenario, it is also important to know how many laboratories would experience one-time costs associated with introducing a new extraction method. EPA assumed that all laboratories that move towards a new method would opt for microwave extraction due to its relatively low cost. EPA estimated that 10 of the 18 labs that would use microwave extraction in the proposed rule scenario would experience one-time costs. This is based on the extrapolated number of labs expected to use microwave extraction in the proposed rule scenario that are not currently certified for that method.
The ten labs that newly adopt microwave extraction would experience three types of one-time costs: purchasing a microwave extraction unit ($30,000), training ($481), and developing their IDC/MDL ($962). Therefore, the total one-time costs per facility are $31,443. This results in estimated total one-time costs of $314,431 spread among the ten relevant labs.
EPA expects that the total number of PCB extractions performed under TSCA would not be impacted by the proposed rule (e.g. the same number of clients would send the same number of samples to commercial laboratories). In order to estimate the costs associated with each type of extraction under the proposed rule scenario, EPA assumed that extractions are distributed evenly among the 22 labs. However, EPA acknowledges that, larger commercial labs would likely receive a disproportionate number of samples. Table 7 breaks down the number of labs and extractions by the baseline extraction method and proposed rule extraction method.

Table 7.	Number of Extractions Performed in Baseline and Under Proposed Rule by Method
                                Baseline Method
                             Proposed Rule Method
                                       
                                3546
Microwave
                            3545A Pressurized Fluid
                            3541
Automated Soxhlet
                                       
                                     Labs
                                  Extractions
                                     Labs
                                  Extractions
                                     Labs
                                  Extractions
3550 Ultrasonic
                                                                              9
                                                                          2,473
                                                                              1
                                                                            275
                                                                              1
                                                                            275
3540C Manual Soxhlet
                                                                              9
                                                                         50,720
                                                                              1
                                                                          5,636
                                                                              1
                                                                          5,636
Total
                                                                             18
                                                                         53,200
                                                                              2
                                                                          5,911
                                                                              2
                                                                          5,911
                                       
Based on the per-sample costs in the baseline and proposed rule scenarios, EPA estimated the per-sample cost savings associated with each relevant method change. The results are presented in Table 8.
Net Cost Impacts
The total net cost impacts of the updates to PCB extraction methods equal the sum of (1) the one-time costs of purchasing equipment and training employees in the first year of the rule's implementation and (2) the annual cost savings related to the reduced time and materials required to conduct PCB extractions using the newly approved extraction methods.  EPA estimates the total net cost impacts over a 20-year timeline, with the assumption that costs related to all new equipment and training are incurred in the first year (2021).  As shown in Table 9 below, the annualized net cost savings of this portion of the proposed rule are $4.25 million, assuming a seven percent discount rate, and $5.95 million assuming a 3 percent discount rate.  In present value terms, the net cost savings of this portion of the proposed rule over the 20-year period analyzed are $84.5 million based on a 7 percent discount rate and $119 million based on a discount rate of 3 percent.
Table 8.	Annual Cost Savings Under Proposed Rule by Baseline and Proposed Rule Method
                                Baseline Method
                             Proposed Rule Method
                                       
                                3546
Microwave
                            3545A Pressurized Fluid
                            3541
Automated Soxhlet
                                       
                            Per Sample Cost Savings
                                  Extractions
                              Total Cost Savings
                            Per Sample Cost Savings
                                  Extractions
                              Total Cost Savings
                            Per Sample Cost Savings
                                  Extractions
                              Total Cost Savings
3550B Ultrasonic
                                                                            $26
                                                                          2,473
                                                                        $64,650
                                                                            $13
                                                                            275
                                                                         $3,600
                                                                            $16
                                                                            275
                                                                         $4,522
3540C Manual Soxhlet
                                                                           $130
                                                                         50,720
                                                                     $6,596,000
                                                                           $117
                                                                          5,636
                                                                       $659,400
                                                                           $120
                                                                          5,636
                                                                       $678,300
Total
                                                                              
                                                                         53,200
                                                                     $6,660,000
                                                                              
                                                                          5,911
                                                                       $663,000
                                                                              
                                                                          5,911
                                                                       $682,800
Note:
 Values in this table do not reflect the one-time costs presented above.


Table 9.	Net Cost Savings of the Proposed Rule (2019 dollars)
                                Baseline Method
                             Proposed Rule Method
                                     Total
                                       
                                3546
Microwave
                            3545A Pressurized Fluid
                            3541
Automated Soxhlet
                                       
                                       
                                  Annualized
                                      PV
                                  Annualized
                                      PV
                                  Annualized
                                      PV
                                  Annualized
                                      PV
3 Percent Discount Rate
3550B Ultrasonic
                                                                        $52,340
                                                                       $778,600
                                                                         $2,678
                                                                        $53,560
                                                                         $3,364
                                                                        $67,280
                                                                        $58,380
                                                                       $899,500
3540C Manual Soxhlet
                                                                     $4,900,000
                                                                    $98,010,000
                                                                       $490,500
                                                                     $9,810,000
                                                                       $504,600
                                                                    $10,090,000
                                                                     $5,895,000
                                                                   $117,900,000
Total
                                                                     $4,953,000
                                                                    $98,780,000
                                                                       $493,200
                                                                     $9,863,000
                                                                       $507,900
                                                                    $10,160,000
                                                                     $5,954,000
                                                                   $118,800,000
7 Percent Discount Rate
3550B Ultrasonic
                                                                        $48,010
                                                                       $508,600
                                                                         $1,907
                                                                        $38,140
                                                                         $2,395
                                                                        $47,910
                                                                        $52,310
                                                                       $594,600
3540C Manual Soxhlet
                                                                     $3,488,000
                                                                    $69,760,000
                                                                       $349,300
                                                                     $6,985,000
                                                                       $359,300
                                                                     $7,186,000
                                                                     $4,196,000
                                                                    $83,930,000
Total
                                                                     $3,536,000
                                                                    $70,270,000
                                                                       $351,200
                                                                     $7,024,000
                                                                       $361,700
                                                                     $7,234,000
                                                                     $4,249,000
                                                                    $84,520,000

Qualitative Benefits Estimation
EPA is proposing to update the allowable PCB extractions methods under TSCA in order to offer laboratories the greatest level of flexibility while maintaining the highest level of scientific integrity. The quantifiable costs and costs savings associated with this proposed rule were discussed in the sections above. However, EPA also anticipates that the proposed rule would result in a variety of benefits that do not lend themselves to quantification.
One benefit that labs that move away from manual Soxhlet extraction would experience is an increase in available laboratory bench and hood space. Manual Soxhlet extraction requires a large amount of glassware, which can take up a significant portion of available bench and hood space in a laboratory, especially if multiple extractions are being performed concurrently. A lack of bench or hood space may be the limiting factor for a laboratory that wants to conduct other scientific tests simultaneously with a PCB extraction. By allowing laboratories to use extraction methods that require less bench space, EPA expects that the proposed rule would lead to an increase in lab efficiency.
Another benefit that laboratories may realize is a reduction in shipping costs. It is often the case that in a large network of commonly owned laboratories, only one or two of them will be equipped to perform TSCA-related PCB extractions using one of the two currently approved methods. If a lab in the network that is not set up for these methods receives a PCB sample that needs to be extracted under TSCA, it will participate in an internal workshare by sending the sample to another lab under the same ownership. The cost of shipping the samples is borne by the laboratory. EPA expects that fewer PCB samples would need to be shipped under the proposed rule, since there would be more laboratories that are certified in acceptable extraction methods.
Finally, EPA expects that there would be environmental benefits associated with a decrease in the generation of hazardous waste due to the newly allowed methods requiring smaller amounts of solvent per sample.

3. 	Updating PCB Determinative Methods
Background
After a sample has been extracted, it is necessary to analyze the sample in order to determine the concentration of PCBs as Aroclors or as individual PCB congeners in the extract. Currently, regulations promulgated pursuant to TSCA require the analysis to be performed using a specific gas chromatographic method (SW-846 Method 8082). If a commercial lab wants to use an alternative determinative method, they must seek prior approval from their EPA regional office. In order to be consistent with other EPA programs and provide greater flexibility to labs, the proposed rule would allow labs to use the following additional determinative methods: SW-846 Methods 8082A and 8275A, CWA Method 1668. 
Identification of Facilities Affected by the Proposed Rule
This portion of the proposed rule applies to any lab that performs analysis of PCBs under TSCA. Based on the available data, it is expected that the universe is comprised of approximately 22 laboratories.
Economic Impact
EPA does not expect this portion of the rule to have an economic impact on the regulated community. The majority of labs that EPA identified as offering PCB analysis currently use Method 8082, or its updated version Method 8082A. These are the methods generally offered even when the sample is not being analyzed for TSCA purposes, meaning the labs already have the option of using alternative methods. This is likely due to Method 8082 and Method 8082A being less costly to perform than other PCB determinative methods. For these reasons, EPA expects the vast majority of labs to continue using Method 8082 or Method 8082A and not experience additional costs or cost-savings due to this provision of the proposed rule.
EPA acknowledges that there are potential cost-savings associated with this portion of the proposed rule. EPA is not aware of a significant number of labs submitting requests to use alternative determinative methods to EPA regional offices. However, under those circumstances, there would be a modest reduction in burden for both the laboratory (no longer having to prepare and submit a request for approval) and the Agency (no longer having to review and respond to requests). EPA is requesting any information or data on labs that have submitted requests for alternative PCB determinative methods in the past or labs that would use a different determinative method than their current method because of the proposed rule.


4. 	Proposed Amendments to performance-based disposal under § 761.61(b) 
Background
This proposed rule would make a number of adjustments to the regulations governing the cleanup and management of PCB remediation waste. In general, PCB remediation waste refers to waste containing PCBs as a result of a spill, release, or other unauthorized disposal at specific concentrations. Currently, TSCA lays out three distinct options for cleaning up PCB-contaminated sites and disposing of PCB remediation waste under 40 CFR 761.61. The options are: § 761.61(a): self-implementing cleanup and disposal, § 761.61(b): performance-based disposal, and § 761.61(c): risk-based disposal. Currently, § 761.61(b) only explicitly addresses disposal of waste. Section 761.61(b) does not require removal of PCB remediation waste at any specified concentration nor does this subsection provide for procedures to demonstrate that cleanup at a site is complete. In order for contaminated sites to be authorized for reuse using § 761.61(b), all PCB remediation waste must be removed from the site and disposed of at a PCB disposal facility. In guidance, EPA has interpreted "all PCB remediation waste" to mean "PCB remediation waste with greater than or equal to (>=) 1 ppm PCBs." This option does not currently require any notification of EPA. 
Proposed Changes
Some of the proposed amendments to the § 761.61(b) option are expected to lead to a small level of burden for the regulated community. The net effect of the proposed changes is expected to decrease burden on the regulated community. 
The proposed changes would create a subsection of § 761.61(b) for performance-based cleanup, while maintaining the existing § 761.61(b) disposal options in a subsection for performance-based disposal. Responsible parties would still be able to use the disposal options in § 761.61(b) with no new constraints. However, for the site to be authorized for reuse, it must be cleaned up under either §§ 761.61(a), (c), or the proposed (b)(1) performance-based cleanup section. Proposed conditions of performance-based cleanup include:
Stating the cleanup levels for bulk remediation waste, porous surfaces, nonporous surfaces, and liquid remediation waste;
Establishing basic recordkeeping requirements;
Limiting the applicability of § 761.61(b) to exclude sites in sensitive ecosystems and sites used by sensitive populations;
Requiring confirmatory sampling in accordance with Subpart O, Subpart P, or § 761.269, based on the type of PCB remediation waste;
Requiring a post-cleanup notification with a summary of the required records;
EPA is not currently proposing to require a pre-notification. However, the Agency is seeking comment on how such a requirement would impact the rulemaking. If a pre-notification submission were required, the burden would be less than or equal to the burden associated with submitting a post-cleanup notification.
Proposed changes to performance-based disposal include:
Adding RCRA Subtitle C landfills to the list of allowable disposal methods for non-liquid PCB remediation waste.
The following sections present EPA's estimate of the economic impact of this portion of the proposed rule.
characterization of the regulated universe
Estimating the number of sites remediated under § 761.61(b) is complicated by the self-implementing nature of the provision. Since site owners are not currently required to submit any notification to EPA stating that they plan to use § 761.61(b) at their site or that they have used § 761.61(b), no relevant database exists. However, EPA does collect notifications under § 761.61(a) and issued approvals under § 761.61(c). In 2018, there were 169 PCB sites remediated under those two options. EPA used manifest data to identify shipments of PCB waste sent to TSCA PCB chemical waste landfills in 2018 and 2019, excluding shipments from generators that submitted notifications under § 761.61(a) or were issued approvals under § 761.61(c), and shipments from Superfund sites. From that subset of the data, waste descriptions were used to sum shipments of PCB remediation waste; the remaining volume, 50 to 60 million kg (55,116 to 66,139 tons) of PCB remediation waste generated at 430 to 460 sites each year, was assumed to originate from sites cleaned up under § 761.61(b).
In order to compensate for the uncertainty related to the number of sites using § 761.61(b), this analysis estimates cost savings using a range with the low-end being one-half the total number of sites using § 761.61(a) and § 761.61(c) (85 sites using § 761.61(b)) and the high-end being twice the combined number of sites using § 761.61(a) and § 761.61(c) (338 sites using § 761.61(b)). 
Methodology and Results
THIS SECTION DESCRIBES EPA'S METHODOLOGY FOR ASSESSING THE COSTS AND COST SAVINGS OF THE PROPOSED RULE RELATED TO CHANGES TO § 761.61(b) and presents the Agency's estimates of these impacts. Estimating the impact of completely new requirements (e.g. submitting a completed cleanup notification) does not require any estimate of a baseline cost. In these cases, EPA simply estimates the cost per party and applies that cost to the estimated universe. However, in the case of changes made to existing provisions (e.g. disposal requirements), EPA first estimates the baseline costs and then estimates the costs in the proposed rule scenario to estimate the cost impact.
costs and Cost Savings
The majority of the costs associated with this portion of the proposed rule are related to performing confirmatory sampling on bulk remediation waste and porous surfaces in accordance with Subpart O, as these materials represent a vast majority of PCB remediation waste. EPA expects that most parties already perform some type of confirmatory sampling, but the stringency of Subpart O may result in parties having more samples analyzed per site. This analysis assumes that in the baseline that sites have between ten and fifteen samples analyzed for PCB contamination. The EA estimates that the number of samples would increase to between eighteen and 28 samples per site under the proposed rule. At a cost of $97 per sample, the baseline sampling costs range from $417,100 to $669,300 and the proposed rule costs range from $750,800 to $1,249,400.
The proposed rule requires that parties that utilize § 761.61(b) meet certain recordkeeping requirements. It is estimated that the cost of keeping such records is approximately $42 per site. Additionally, the proposed rule would require relevant parties to submit a post-cleanup notification to EPA that is not currently required with a copy sent to the state, tribal, and local environmental agencies. EPA estimates that completing and submitting the notification to the required entities costs $61.
EPA is also proposing a cost-saving feature in the proposed rule that allows parties to send their PCB remediation waste to RCRA Subtitle C landfills. This reduces costs in two ways. First, it reduces the cost of transportation. Currently, non-liquid remediation waste from a site remediated under § 761.61(b) must go to a TSCA-permitted disposal facility, of which TSCA chemical waste landfills are the most cost-effective. There are only approximately twelve chemical waste landfills in the entire country. The low number of TSCA landfills results in long shipping distances, which increases costs. In contrast, there are approximately 25 RCRA Subtitle C landfills, which would decrease the distance that waste must be shipped under the proposed rule. Disposal at RCRA Subtitle C landfills results in cost savings beyond those of transporting the waste, because the tipping fees for non-hazardous, non-liquid PCB waste at RCRA Subtitle C landfills are lower than those at TSCA landfills (see below).
In general, the § 761.61(b) option is utilized by parties remediating small-scale sites. This reflects the relative costs of the different options, as parties are generally weighing the cost of interfacing with EPA under § 761.61(a) or § 761.61(c) (e.g. paperwork, man-hours) against the higher disposal costs under § 761.61(b). The economics of these counter-veiling effects favor a § 761.61(b) cleanup only for smaller sites. However, no data exist on the exact tonnage of relevant waste for § 761.61(b) disposals. As stated in the characterization of the regulated universe, EPA estimates that 50 to 60 million kg of PCB remediation waste are generated at 430 to 460 sites cleaned up under § 761.61(b) each year. This estimate is based on manifest data from 2018 and 2019. Therefore, EPA estimated the cost of transporting and disposing of PCB remediation waste for a range of 128 to 144 tons per cleanup.
The cost of transporting § 761.61(b) waste is similar to the cost of transporting RCRA hazardous waste. This EA assumes that each hazardous waste shipment has a fixed cost of $220 and an additional cost of $0.22 per ton-mile. In the baseline, it is assumed that a party must ship its waste approximately 800 miles to a TSCA landfill. However, in the proposed rule scenario the assumed shipping distance is reduced to 200 miles due to the larger number of RCRA Subtitle C landfills compared to TSCA landfills.
The per-ton cost of disposal for non-hazardous, non-liquid PCB remediation waste is also generally lower at a RCRA Subtitle C landfill in comparison to TSCA landfills. The per-ton cost of disposal is variable and can depend on factors such as capacity and volume. This EA assumes that waste disposed of at TSCA landfills (the baseline scenario) costs $167.50 per ton. Waste disposed of at a RCRA Subtitle C landfill (the proposed rule scenario) is assigned a cost of $125 per ton.
results

In order to arrive at the net impact of this portion of the proposed rule, EPA calculated costs for the baseline scenario and the proposed rule scenario. In order to do so, EPA  estimated a "low estimate" and a "high estimate". The low estimate assumed that there are 430 cleanups per year, the average cleanup has 128 tons of PCB remediation waste, and ten samples are analyzed per site. The high estimate assumed that there are 460 cleanups per year, the average cleanup has 144 tons of PCB remediation waste, and fifteen samples are analyzed per site. The proposed rule scenario assumes that there are eighteen samples analyzed in the low estimate and 28 samples analyzed in the high scenario.
Under the baseline scenario, facilities experience no recordkeeping or notification costs. The total estimated range of transportation and disposal costs in the baseline is $19.8 million to $23.7 million per year. The range of annual transportation and disposal costs in the proposed rule scenario is $10.2 million to $12.2 million. The costs associated with sampling in the baseline range from $417,100 to $669,300. In the proposed rule scenario these costs range from $750,800 to $1,249,000. Under the proposed rule scenario, the range of recordkeeping and notification costs is $44,290 to $47,380 per year. This portion of the proposed rule is expected to result in annual cost savings between $9.1 million and $10.9 million. Table 10 presents the costs and cost savings results.
      Table 10.	Overall, Annual § 761.61(b) Cost Savings
                                  Input/Cost
                                   Baseline
                                 Proposed Rule
                                 Cost Savings
                                       
                                 Low Estimate
                                 High Estimate
                                 Low Estimate
                                 High Estimate
                                 Low Estimate
                                 High Estimate
Number of Sites
                                                                            430
                                                                            460
                                                                            430
                                                                            460
                                                                             85
                                                                            338
Tons of Waste per Site
                                                                            128
                                                                            144
                                                                            128
                                                                            144
                                                                             10
                                                                             90
Samples per Site
                                                                             10
                                                                             15
                                                                             18
                                                                             28
                                                                             18
                                                                             28
Sample Analysis
                                                                      $417,100 
                                                                      $669,300 
                                                                      $750,800 
                                                                    $1,249,000 
                                                                     ($333,700)
                                                                     ($580,100)
Recordkeeping
                                                                             $0
                                                                             $0
                                                                        $18,060
                                                                        $19,320
                                                                      ($18,060)
                                                                      ($19,320)
Post-Cleanup Notification
                                                                             $0
                                                                             $0
                                                                        $26,230
                                                                        $28,060
                                                                      ($26,230)
                                                                      ($28,060)
Transportation
                                                                    $10,550,000
                                                                    $12,650,000
                                                                     $3,276,000
                                                                     $3,922,000
                                                                     $7,275,000
                                                                     $8,730,000
Disposal
                                                                     $9,232,000
                                                                    $11,080,000
                                                                     $6,889,000
                                                                     $8,267,000
                                                                     $2,342,000
                                                                     $2,811,000
                                                             Total Cost Savings
                                                                     $9,240,000
                                                                    $10,910,000


Table 11 displays the net present value cost savings of the proposed § 761.61(b) revisions, assuming a 20-year timeline of the proposed rule.  As shown in the table, net present value cost savings are between $137.5 million and $162.4 million at a three percent discount rate, and between $97.9 million and $115.6 million at a seven percent discount rate.
TABLE 11.NET PRESENT VALUE OF § 761.61(B) COST SAVINGS
                                 Cost Savings
                            3 Percent Discount Rate
                            7 Percent Discount Rate
                                       
                                      Low
                                     High
                                      Low
                                     High
Net Present Value
                                                                  $137,500,000 
                                                                  $162,400,000 
                                                                   $97,890,000 
                                                                  $115,600,000 
                                                                               

The revisions to the § 761.61(b) are also expected to produce qualitative benefits. The additional sampling requirements are expected to increase the accuracy of assessing the state of a site with relation to PCB contamination. Additionally, requiring a post-cleanup notification would provide EPA with information on when and where cleanups are occuring under § 761.61(b). Finally, these revisions will increase regulatory certainty for the regulated community by increasing the clarity of the cleanup standards.

5. 	REMOVAL OF REGULATORY PROVISION ALLOWING DISPOSAL OF PCB BULK PRODUCT WASTE AS ROADBED
Historically, facilities have had the option of disposing of PCB bulk product waste (BPW) under asphalt as roadbed, although this option has rarely been utilized by the regulated community. Under the proposed rule, the option of disposing of PCB bulk product waste as roadbed would be removed due to the potential for migration of PCBs to adjacent environmental media. The primary benefit of this provision is preventing the potential migration of PCBs, which otherwise could have negative impacts on human health and the environment.
Methodology and Results
Data on the exact number of parties that have used PCB bulk product waste under asphalt as roadbed do not exist, as there is no notification requirement. However, EPA believes that this practice is exceedingly rare. The Agency is aware of only one confirmed instance of this type of use. However, in order to take all potential cost impacts of this provision into account, this analysis assumes that PCB BPW would be used under asphalt as roadbed once each year.
Facilities that would have used PCB BPW as roadbed in the absence of the proposed rule would likely face two types of increased costs. First, they would have to pay to transport the BPW to a municipal solid waste landfill, rather than keeping it on-site to be used as roadbed. Second, they would have to pay a tipping fee for disposal of the waste. This analysis assumes that the waste will travel an average of 50 miles to a municipal solid waste landfill and the cost of transportation is $0.22 per ton-mile. Additionally, the average tipping fee at a MSWLF is approximately $55 per ton. In the absence of data on the average amount of PCB BPW used as roadbed under asphalt, EPA estimated the economic impact using a range of 10 to 90 tons per instance, based on disposal notifications provided by sites that were disposing of PCB remediation waste less than 50 ppm under a blanket § 761.61(c) approval.

The results of the economic analysis for this provision of the rule are presented in Table 12. On the low end, the analysis expects for costs to increase by approximately $660 each year. In the 90-ton (high estimate) scenario, costs are expected to increase by $5,950 per year. Table 13 estimates that the net present value of the changes over a twenty-year period are between $9,800 and $88,500 using a three percent discount rate and between $7,000 and $63,000 using a seven percent discount rate. The (non-quantified) potential benefits of this provision include avoided exposure to PCBs and decreased healthcare expenditures.
Table 12.	Annual PCB Bulk Product Waste as roadbed cost savings
                                  Input/Cost
                                   Baseline
                                 Proposed Rule
                                 Cost Savings
                                       
                                 Low Estimate
                                 High Estimate
                                 Low Estimate
                                 High Estimate
                                 Low Estimate
                                 High Estimate
Disposal at MSWLF
                                                                            $0 
                                                                            $0 
                                                                          $551 
                                                                        $4,960 
                                                                         ($551)
                                                                       ($4,960)
Transportation to MSWLF
                                                                            $0 
                                                                            $0 
                                                                          $110 
                                                                          $990 
                                                                         ($110)
                                                                         ($990)
                                                             Total Cost Savings
                                                                         ($661)
                                                                       ($5,950)

TABLE 13.NET PRESENT VALUE OF PCB BULK PRODUCT WASTE AS ROADBED COST SAVINGS
                                 Cost Savings
                            3 Percent Discount Rate
                            7 Percent Discount Rate
                                       
                                      Low
                                     High
                                      Low
                                     High
Net Present Value
                                                                       ($9,835)
                                                                      ($88,520)
                                                                       ($7,004)
                                                                      ($63,030)

6.  	Flexibilities for emergency situations
In addition to updating regulations governing PCB extraction methods under TSCA and the cleanup and disposal of PCB remediation waste, this proposed rule aims to make other adjustments to existing PCB regulations. One such change is updating the protocol for how regulated spills caused by emergency situations may be cleaned up. This section of the EA provides background on the current status of PCB-contaminated disaster debris cleanups, details the proposed changes, and provides a qualitative economic assessment of the costs and cost savings of these provisions.
Background
In general, when PCB remediation waste is found, the responsible party must follow the provisions in 40 CFR 761.61 for cleanup and disposal. However, EPA has provided separate protocols under the Spill Cleanup Policy, which may be used when applicable. EPA recognizes that under adverse conditions created by a disaster (e.g., hurricanes, wildfires), additional changes to the cleanup protocol may be appropriate. The Spill Cleanup Policy currently recognizes that "There may also be exceptional spill situations that require less stringent cleanup or a different approach to cleanup because of factors associated with the particular spill. These factors may mitigate expected exposures and risks or make cleanup to these requirements impractical." (40 CFR 761.120(a)(4)).
Currently, when a relevant emergency is imminent and is likely to impact PCB resources, an EPA regional office may issue a guidance document that provides select storm-specific flexibilities and instructions for responsible parties related to how to handle PCB-contaminated disaster debris. Each guidance applies only to cleanups that are connected to the disaster. 
EPA has used this provision to issue storm-specific guidance in Regions 4 and 6 for Hurricanes Katrina (2005), Harvey (2017),  Irma (2017) , Florence (2018) , Michael (2018), Dorian (2019) and Tropical Storm Barry (2019). Although each guidance document is unique, they contain many similar provisions, which include disposing of soil and debris contaminated with PCB oil of an unknown source on an "as-found" basis, and extending the time limit within which notifications must be submitted to EPA and other regulators.
Proposed Changes
EPA recognizes that issuing disaster guidance on a case-by-case basis can create some inefficiencies. First, since disasters can develop without much forewarning, they can put pressure on EPA to develop the guidance very quickly so that it may be distributed to the regulated community in time for facilities to use it. This can be particularly challenging when disasters develop outside of normal work hours. Also, the fast-paced nature of the response to such events means that entities that could use the guidance may not become aware that it was issued in time to use it. Finally, due to uncertainty regarding whether a guidance document will be issued, it is often challenging for regulated facilities to take advantage of the flexibilities offered in the EPA guidance and incorporate them into their disaster preparation protocols.
In light of these circumstances, EPA is proposing two different approaches to incorporate flexibility for managing PCB-contaminated disaster debris in emergency situations. EPA is looking for comment on both approaches and may finalize either option or both options. The proposed language would define an emergency situation based on declarations made by third parties (e.g. FEMA, a Governor). 
The first proposed change would codify in the Spill Cleanup Policy the types of provisions that have historically been included in the guidance documents issued by EPA's regional offices. This option would also allow for cleanups based on the "as-found" concentration. In addition, this option would extend the timeframe for notification of cleanup activities. These provisions are meant to provide flexibility to the regulated community, and EPA also expects that they would result in cost savings for the regulated entities and for the Agency. EPA believes that the proposed flexibilities would not present an unreasonable risk of injury to health or the environment under the defined emergency situations but rather would result in a net benefit in protection of health and the environment, given that they allow the responsible party to assess and dispose of waste more quickly, and prioritize time-sensitive remedial actions over notification. This option will be referred to as the "Spill Cleanup Policy option."
The second proposed option would create a waiver program (the "waiver option"). The waiver option would allow site owners to request a waiver from any aspect(s) of §§ 761.60, 761.61, 761.62, or 761.65 that is made impracticable due to spills caused by an emergency situation. This option does not specify what EPA would allow, but rather allows the site owner to ask for situation-specific regulatory relief. The EPA could grant or deny such a waiver request or may grant the request with changes or conditions beyond those described in the waiver request.
UNDER THE WAIVER OPTION, THE RESPONSIBLE PARTY MUST SUBMIT A WAIVER REQUEST TO THE EPA REGIONAL ADMINISTRATOR NO LATER THAN 7 days after discovery of the PCB waste or after the initial emergency response as the emergency situation allows. The waiver request must contain information such as the location of the spill, the type of media that is contaminated, the as-found PCB concentrations in the contaminated media, the conditions that the party is seeking relief from and why the emergency situation makes compliance impracticable, and a proposed storage, cleanup, and/or disposal plan for the PCB waste. The EPA Regional Administrator may approve the waiver request, or approve the waiver request with specified changes or additional conditions if he or she finds that the waiver request will not pose an unreasonable risk of injury to health or the environment. This option would also provide relief to the regulated community by allowing for an adjustment to the regulations that is tailored to the circumstances of the disaster and the site.  
Economic Assessment of Costs and Cost Savings
EPA expects that both of the selected options would result in cost savings for the regulated community. Estimating the amount of cost savings that would be experienced is difficult due to a lack of data on the number of PCB cleanups in emergency situations (defined in the proposed text) and the associated costs. Further, there is inherent uncertainty in the number of disasters that will occur in a given year, where they will occur, and what their impact on PCB resources and the regulated community will be. In this section, EPA qualitatively discusses the economic impact of the proposed provisions. 
The Number of Relevant Disasters
To discuss the number of facilities that would be affected by the proposed rule, it is necessary to estimate the number of emergencies that would qualify for regulatory relief under each proposed option (the universe of relevant disasters is the same). Each proposed regulatory option would define an emergency situation as "adverse conditions caused by manmade or natural incidents that threaten lives, property, or public health and safety and require prompt responsive action from the local, state, tribal, territorial, or federal government that result in: (1) a declaration by either the President of the U.S. or Governor of the affected State of a natural disaster or emergency; or, (2) an incident funded under FEMA via a Stafford Act disaster declaration or emergency declaration. Examples of emergency situations may include civil emergencies, hurricanes, tornados, or other similar adverse weather conditions."
The first instance of an EPA regional office issuing guidance for PCB-contaminated disaster debris was in 2005 in response to Hurricane Katrina and Hurricane Rita. In the fourteen years since then, EPA regional offices have offered such guidance for five additional hurricanes and one tropical storm. This results in an average of 0.4 relevant disasters per year. However, the language of the proposed changes widens the scope of the relevant disasters and would likely result in facilities taking advantage of regulatory relief in situations for which a guidance document has not previously been issued.
In order to estimate the number of relevant disasters, EPA relied on information from the FEMA Disaster Declarations Summary. According to this dataset, there were 241 declared disasters between 2015 and 2018, for an average of approximately 60 disasters per year. Only five of these (Hurricane Katrina, Hurricane Florence, Hurricane Harvey, Hurricane Michael, and Hurricane Irma) resulted in guidance being issued by EPA for PCB-contaminated disaster debris. This dataset, however, covers only federal disaster declarations, whereas the rule also considers disasters declared by the Governor of an individual state. Unfortunately, data on the number of disasters declared each year at the state level are not readily available. EPA does not believe, however, that excluding disasters declared by states will result in an underestimate of relevant disasters, because there is significant overlap between state and federally declared emergencies. 
EPA estimates that up to 60 emergencies per year may be impacted by changes to the disaster debris program. However, the actual number of relevant emergencies is likely lower than this. Historically, the guidance documents have been in response to hurricanes. If EPA excludes other types of declared disasters (e.g. earthquakes, snow, etc.), then the averages drops to 12 emergencies per year. Furthermore, the declared disasters would have to have a direct impact on PCB resources for the provisions of the proposed changes to be relevant.
Impacted Parties and Cleanups
The proposed changes could potentially impact any party performing a cleanup of PCB waste in the wake of an emergency. Historically, the utilities industry (NAICS code 22) has had to perform PCB cleanups after disasters, because many transformers and other electrical equipment contain PCBs. However, other parties that have PCB waste due to emergencies would also be impacted. EPA reached out to relevant groups in an effort to estimate how many PCB cleanups currently occur as a result of disasters and how many could be expected to be performed in the future. Unfortunately, EPA did not receive any quantitative estimates and there are no available data related to the topic. As such, EPA requests comments and data on the number of PCB cleanups related to emergencies and their associated costs.   
Economic Impact of Provisions
Due to the lack of data, EPA is unable to estimate the total economic impact of the provisions of the proposed rule related to handling PCB waste in emergency situations. In this section, EPA provides a qualitative discussion of the economic impact of the relevant aspects of the proposed rule.
The primary cost savings from this section of the proposed rule are expected to result from the expansion of the number of emergencies experiencing regulatory relief. EPA only issued disaster debris guidance documents for six occasions since 2005. However, during this period there were dozens of emergencies that would qualify as "emergency situations" under the proposed rule. The parties responsible for those cleanups would potentially experience cost savings that would not have been available to them if the issuance of a disaster debris guidance document was required. By allowing the party to clean up the spill in accordance with the "as-found" concentration, the party can avoid a costly and time-consuming search for the source of the spill. Additionally, the Agency would experience cost savings from no longer having to issue individual guidance documents.
The cost savings associated with the waiver option are more open ended, since parties can request regulatory relief related to a wide array of requirements (e.g. sampling, extraction, analysis, cleanup, storage, and disposal). It can be assumed that cost savings would result under this option as well, since it is unlikely that any party would request a waiver for a costlier cleanup process. The impacted party would incur a small burden in the form of submitting a waiver request to the EPA (the Agency would also experience a small burden of reviewing the waiver requests). However, it is expected that the reduction in cleanup costs would far outweigh the cost of creating and submitting a waiver request.
The qualitative benefits of adding flexibilities for emergency situations include regulatory certainty for the impacted parties. The knowledge that such provisions will be in place for any declared emergency would allow facilities to incorporate the provisions into their emergency management plan, which could lead to more timely actions. Cleanups may also become timelier because parties may not have to search for the source of a spill. 



7. 	 harmonize General Disposal Requirements for PCB Remediation Waste
Background
In the 1998 PCB Megarule (63 FR 35384), EPA promulgated both the definition of PCB remediation waste in § 761.3 and a guide to the cleanup and disposal obligations for PCB remediation waste in § 761.50(b)(3). At the time of 1998 Megarule, § 761.50(b)(3) failed to account for the fact that disposal of PCBs < 500 ppm was not regulated between April 18, 1978, (the effective date of the Disposal and Marking Rule, which set the 500 ppm threshold) and July 2, 1979, (the effective date of the PCB Ban Rule, which replaced the 500 ppm level with 50 ppm). A technical amendment to correct this was issued in 1999 (64 FR 33755) without notice and comment. The preamble text addressed changes made to § 761.50(b)(3)(i), which was amended accordingly. Section 761.50(b)(3)(ii) was also amended, presumably to correct the same discrepancy for the time between April 18, 1978 and July 2, 1979. However, the phrase "at as-found concentrations >= 50 ppm" was added to § 761.50(b)(3)(ii) unnecessarily. This was apparently an error; there is no justification in the preamble for the change, and it cuts against the apparent intent to better align § 761.50(b)(3) with the definition of PCB remediation waste and the general direction in § 761.50(b)(3) that PCB remediation waste "is regulated for cleanup and disposal in accordance with § 761.61." This phrase causes the language of § 761.50(b)(3)(ii) to be in conflict with the definition of remediation waste in § 761.3, which includes materials which are currently at any volume or concentration where the original source was >= 500 ppm PCBs beginning on April 18, 1978, or >= 50 ppm PCBs beginning on July 2, 1979. EPA maintains that all materials that fit the definition of PCB remediation waste in § 761.3 are regulated for disposal under § 761.61. In support of this point, the 1998 Megarule preamble states, "With regard to sites containing PCB remediation wastes generated on or after April 18, 1978, owners or operators of those sites now have two choices: they may clean up the wastes in accordance with new § 761.61, or, if applicable, they may cleanup the wastes in accordance with EPA's Spill Cleanup Policy, part 761, subpart G." EPA has published guidance that supports this position. EPA has also issued numerous risk-based disposal approvals in the past five years that apply only to < 50 ppm PCB remediation waste. 
Proposed changes and economic impact
EPA is proposing to change the language in § 761.50(b)(3)(ii) by removing the phrase "at as found concentrations >= 50 ppm." EPA has been clear in other regulatory provisions, preamble, guidance, and ongoing interactions with regulated entities, that PCB remediation waste at as-found concentrations < 50 ppm PCBs is regulated for cleanup and disposal under § 761.61. In this context, EPA interprets the "as found" provision as expressly allowing for disposal of PCB remediation waste with as-found concentrations >= 50 ppm in accordance with the Spill Cleanup Policy, as provided in § 761.50(b)(3)(ii)(A), as an additional option to disposal under § 761.61, as provided in § 761.50(b)(3)(ii)(B). Disposal under § 761.61 is already provided for in the chapeau to § 761.50(b)(3). EPA finds this proposed change would reconcile this unintentional conflict with the overall structure and language of the regulations. The impact of the proposed change would be to clarify that < 50 ppm PCB remediation wastes may be managed under the PCB Spill Cleanup Policy, subject to the criteria of the policy. Since this regulatory change is in line with current EPA policy, guidance, and practice, EPA estimates no net economic impacts from this change.


8. 	Net Economic Impacts of the Proposed Rule
The net cost savings of this proposed rule include three categories of quantified costs and cost savings presented in Chapters 2, 3, and 6 above: cost savings related to the updates to PCB extraction methods, cost savings related to updates to § 761.61(b), and costs related to disallowing PCB BPW to be used as roadbed.  All other proposed provisions are not estimated to have incremental economic impacts or are only able to be discussed qualitatively due to data limitations. As summarized in Table 14 below, the total quantifiable annualized net cost savings of the proposed rule are between $15.2 million and $16.9 million at a three percent discount rate, and between $13.5 and $15.2 million at a seven percent discount rate. 
	table 14	Net Cost Savings of the Proposed Rule 
                            Proposed Rule Provision
                               Net Cost Savings
                                       
                                      Low
                                     High
                                       
                                  Annualized
                                 Present Value
                                  Annualized
                                 Present Value
3 PERCENT DISCOUNT RATE
PCB Extraction Methods
                                                                    $5,954,000 
                                                                  $118,800,000 
                                                                    $5,954,000 
                                                                  $118,800,000 
§ 761.61(b)
                                                                    $9,240,000 
                                                                  $137,500,000 
                                                                   $10,910,000 
                                                                  $162,400,000 
PCB BPW as Roadbed
                                                                         ($661)
                                                                       ($9,835)
                                                                       ($5,950)
                                                                      ($88,520)
Total
                                                                   $15,190,000 
                                                                  $256,300,000 
                                                                   $16,860,000 
                                                                  $281,100,000 
7 PERCENT DISCOUNT RATE
PCB Extraction Methods
                                                                    $4,249,000 
                                                                   $84,520,000 
                                                                    $4,249,000 
                                                                   $84,520,000 
§ 761.61(b)
                                                                    $9,240,000 
                                                                   $97,890,000 
                                                                   $10,910,000 
                                                                  $115,600,000 
PCB BPW as Roadbed
                                                                         ($661)
                                                                       ($7,004)
                                                                       ($5,950)
                                                                      ($63,030)
Total
                                                                   $13,490,000 
                                                                  $182,400,000 
                                                                   $15,160,000 
                                                                  $200,100,000 
Emergency Situations
                       Non-quantifiable net cost savings
Determinative Methods
                              No economic impact
§ 761.50(b)(3)
                              No economic impact

9. 	Equity Considerations and Other Impacts
As required by applicable statutes and executive orders, this chapter summarizes EPA's analysis of equity considerations and other regulatory concerns associated with the proposed rule. This chapter assesses potential impacts, with respect to the following issues: 
Regulatory planning and review: requires examination and quantification of costs and benefits of regulating with and without the rule;
Regulatory flexibility: focuses on the potential effects of the rule on small entities; 
Employment impacts: assesses the potential impact of the rule on employment; 
Unfunded mandates: examines the implications of the rule with respect to unfunded mandates; 
Federalism: considers potential issues related to state sovereignty; 
Tribal governments: extends the discussion of federal unfunded mandates to include impacts on Native American tribal governments and their communities; 
Energy Impacts: examines the impacts of the rule on energy use, supply, and distribution; 
Environmental justice: considers potential issues for minority and low-income populations; 
Children's health protection: examines the potential impact of the rule on the health of children; and
Joint impacts of rules: considers the combined effect of the rule with other regulations.
National Technology Transfer and Advancement Act: requires federal agencies to Use technical standards developed or adopted by voluntary consensus standards bodies if compliance would not be inconsistent with applicable law or otherwise impracticable;
REGULATORY PLANNING AND REVIEW


This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review for review under Executive Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket. 
Regulatory Flexibility
The Regulatory Flexibility Act (RFA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 USC 601 et seq., generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute. This analysis must be completed 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 organizations, and small governmental jurisdictions. Based on EPA's RFA/SBREFA analytic guidance, a rule is not expected to result in a significant economic impact for a substantial number of small entities if the costs of the regulation for a facility are less than one percent of annual revenues. 
EPA does not expect the rule to result in an adverse impact to a significant number of small entities, since the rule is expected to result in net cost savings. 
EmploymeNt Impact Analysis
Executive Order 13777 directs federal agencies to consider a range of issues regarding the characteristics and impacts of regulations, including the effect of regulations on jobs (Executive Order 13777, 2017). Employment impacts of environmental regulations include a mix of potential declines and gains in different sectors of the economy over time. Impacts on employment can vary according to labor market conditions and may differ across occupations, industries, and regions. Isolating employment impacts of regulation is difficult as they are a challenge to disentangle from employment impacts caused by a plethora of ongoing concurrent economic changes.  
Ideally, EPA would conduct a quantitative assessment of these impacts, but insufficient data are available to quantify changes in employment associated with the rule. This EA therefore presents a qualitative assessment of the rule's potential employment impacts.
EPA expects that the proposed rule may result in competing employment effects. The rule is likely to reduce expenditures on labor for PCB extraction testing, which may decrease employment, all else equal. However, the reduction in expenditures on PCB extraction testing may result in a marginal reduction in the prices charged by these firms for the goods and services that they produce. To the extent that prices charged by these firms decline, demand for their products may increase and they may therefore demand additional labor. EPA also expects the other provisions in the proposed rule to result in competing employment impacts. It is unclear which of the two employment effects is more significant, but EPA expects the net employment impact of all provisions in the proposed rule to be negligible. 
Unfunded Mandates
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531 - 1538, and does not significantly or uniquely affect small governments. EPA estimates that the proposed rule would result in net annual cost savings of between $4.3 and $9.1 million, assuming a seven percent discount rate. As a result, EPA expects that the rule would not result in annual expenditures exceeding $100 million annually and therefore would not be subject to requirements of Section 202 of UMRA as listed above. 
Federalism
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
Tribal Governments
This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000) because the action is expected to result in net cost savings and otherwise is not expected to result in any adverse impacts on tribal entities. Thus, Executive Order 13132 does not apply to this rule. 
Energy ImPacts
THIS ACTION IS NOT A "SIGNIFICANT ENERGY ACTION" UNDER EXECUTIVE ORDER 13211, "ACTIONS CONCERNING REGULATIONS THAT AFFECT ENERGY SUPPLY, DISTRIBUTION, OR USE" (MAY 18, 2001) BECAUSE IT IS NOT LIKELY TO HAVE A SIGNIFICANT ADVERSE EFFECT ON THE SUPPLY, DISTRIBUTION OR use of energy. The proposed rule would not directly regulate energy production or consumption and is expected to result in net cost savings.
Environmental Justice
EPA believes that this action does not have disproportionately high and adverse health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). In fact, this action is expected to benefit these populations.
Generally, the proposed rule would modernize the PCB regulations, making it easier and more affordable to clean up contaminated sites, while continuing to ensure that the requirements remain protective of health and the environment. Underserved, disadvantaged, and overburdened communities are expected to benefit from quicker, more cost-effective, compliant cleanups under the proposed rule. For example, adding explicit cleanup provisions under §761.61(b), including the requirements to notify EPA and follow specific sampling protocols, would provide additional assurance that sites are properly remediated and enable compliance and enforcement. Furthermore, flexibility for emergency situations would allow the Agency to work collaboratively with responsible parties to quickly respond to releases of PCBs caused by natural disasters and other emergency situations, which often disproportionately impact such communities. 
None of the provisions in the proposed rule are expected to have a negative impact on the health or environmental quality of any communities.
Children's Health Protection
This action is not subject to Executive Order 13045 (62 FR. 19885, April 23, 1997) because it is not an economically significant regulatory action as defined by Executive Order 12866. In addition, because the rule would not increase risk related to exposure to hazardous materials, the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.
Joint iMpacts of Rules
Some laboratories may already have the requisite equipment to conduct extractions under the methods proposed by the rule because of compliance with other EPA regulations.  In these cases, the laboratories would not need to purchase new equipment and the estimated cost savings presented in this document would represent an underestimate of cost savings related to the proposed rule.
NATIONAL TECHNOLOGY TRANSFER AND ADVANCEMENT ACT (NTTAA)
The NTTAA requires federal agencies to use technical standards developed or adopted by voluntary consensus standards bodies if compliance would not be inconsistent with applicable law or otherwise impracticable and consult with voluntary, private sector, consensus standards bodies and shall, when such participation is in the public interest and is compatible with agency and departmental missions, authorities, priorities, and budget resources, participate in the development of technical standards.
EPA is relying on voluntary consensus standards developed by ASTM and already in use in the laboratory testing sector, which is consistent with the National Technology Transfer and Advancement Act (NTTAA). Additionally, EPA has consulted with potentially impacted laboratories.



