Document ID: EPA-HQ-RCRA-2001-0032-0185
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-12-13T05:00Z

RESPONSE TO COMMENTS DOCUMENT
                                       
HAZARDOUS WASTE MANAGEMENT SYSTEM: MODIFICATIONS OF THE HAZARDOUS WASTE MANIFEST SYSTEM; NOTICE OF DATA AVAILABILITY AND REQUEST FOR COMMENT
                                       
                          Published on April 18, 2006
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                               November 12, 2013
                                       
                                       
                                       
                                       
TABLE OF CONTENTS

BACKGROUND AND PURPOSE OF DOCUMENT	1
Background	1
Purpose of Document	2
SUMMARY OF PUBLIC COMMENTS AND AGENCY RESPONSES ON E-MANIFEST NOTICE	2
1.0	General	2
1.1	Support	2
1.2	EPA Collaboration With Stakeholders	3
1.3       State Adoption and Roles	6
1.4	Effects of Dual Paper and Electronic Manifest Systems	10
1.5	Estimated Costs and Benefits	11
1.6	Authorizing Legislation and Funding	14
2.0	Final Rule	18
2.1	General	18
2.2	Voluntary or Mandatory Use of e-Manifest	21
3.0	Conceptual Design of E-Manifest	23
3.1	Extensible Markup Language (XML)	23
3.2	Technical Standards - General	23
3.3	Access Controls/Protections over Data	25
3.4	System Compatibility	31
3.5	System Security	31
3.6	System Failure	32
3.7	Central Repository	33
3.8	Gradual Roll-out/Scalability	34
3.9	Integration of e-Manifest into Existing Regulatory Program	36
Table of Organizations Commenting on the Notice and Commenter Numbers	40

BACKGROUND AND PURPOSE OF DOCUMENT
Background

On May 22, 2001, EPA published a notice of proposed rulemaking to revise the hazardous waste manifest system (66 FR 28240).  The proposed revisions aimed to reduce the manifest system's paperwork burden on users, while enhancing the effectiveness of the manifest as a tool to track hazardous waste shipments.  The proposed rule would have accomplished this by adopting a standardized manifest form with fewer or no optional data fields; adopting a new approach for distributing and acquiring the form; standardizing the data elements and procedures for tracking certain types of hazardous waste shipments; and allowing the manifest to be completed, signed, transmitted, and stored electronically.  Thus, the proposed rule consisted of manifest system reforms of two distinct types: (1) revisions to the manifest form and the procedures for using the form and (2) revisions aimed at replacing the paper-based manifest system with a nearly paperless, electronic approach to tracking hazardous waste shipments (referred to as the "e-Manifest" in this document).  The 2001 proposed rule, however, included a decentralized approach to electronic manifesting.  With this approach, EPA would issue detailed standards governing electronic manifest systems, and the private sector could develop perhaps multiple systems and approaches adhering to EPA's standards.

﻿Public comments on the proposed rule generally supported our goals of further standardizing the manifest form elements and reducing variability among the manifests that authorized RCRA state agencies currently distribute.  However, the commenters had differing views on many of the particulars of the proposed revisions to the manifest.  ﻿We believed that the comments addressing the e-Manifest proposal raised significant substantive issues that merited further analysis and stakeholder outreach prior to adopting a final approach. In particular, the comments raised several strong objections to the decentralized electronic manifest approach proposed in May 2001, and suggested that a consistent, national system could be a preferable approach.  The comments received in response to the form revisions proposal, on the other hand, raised fewer difficult issues that would deter us from going forward with a final rule.  Therefore, EPA separated the e-Manifest from the form revisions portion of the proposal for purposes of taking final action.  EPA published a final rule on the form revisions on March 4, 2005 (70 FR 10776).

Since the 2001 proposal, EPA  continued work on the e-Manifest.  In particular, EPA held a two-day public meeting in May 2004 to discuss and obtain public input on a national e-Manifest system. The purpose of the meeting was to discuss with stakeholders our rulemaking progress and to solicit their input and preferences on the development and implementation of the e-Manifest project. EPA also presented material on alternative information technology (IT) approaches to the e-Manifest, including a centralized approach under which EPA or another entity would host a web-based national system.  As a result of these stakeholder discussions and subsequent analysis of possible system options, EPA concluded that a centralized, national e-Manifest system is the preferred approach in proceeding with the rulemaking authorizing the use of electronic manifests.

On April 18, 2006, EPA published a Notice of Data Availability and Request for Comment (71 FR 19842).  The notice described the Agency's general approach to an e-Manifest system, including a conceptual design of the e-Manifest, and it explained our changed program direction favoring a centralized, national e-Manifest approach.  It also indicated EPA's intent to consider the data obtained from the public meeting and any new data from public comments received on the notice in making a final decision on whether to develop a national e-Manifest system.  In total, EPA received 31 public comment letters in response to the notice.
Purpose of Document

This document presents a summary of the public comments received in response to the April 2006 notice.  The public comments (e.g., suggestions, concerns, questions) are summarized according to specific issues related to the proposed rule and preamble.  

In each summary, we indicate the number of organizations whose comments are reflected in it.  We also identify the organizations.  To do so, we assigned each organization a unique commenter number.  We then prepared the summaries and inserted commenter numbers into each summary to identify the organizations whose comments are reflected in it.  A table at the end of this document provides the name of each organization that commented on the notice and its commenter number.

This document also provides the Agency's response to each comment.  The responses clarify how the comments were considered in developing the final e-Manifest approach.  This document does not address comments that are outside the scope of the e-Manifest. 

SUMMARY OF PUBLIC COMMENTS AND AGENCY RESPONSES ON E-MANIFEST NOTICE
1.0	General

	1.1	Support

Comment:  We heard from 25 commenters that indicated their general support for the general national, centralized system approach laid out in the 2006 notice (Commenter Nos. 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 21, 24, 25, 26, 27, 28, 29, and 30).  In expressing their general support, a number of these commenters stated that the support is contingent upon EPA's revising its approach based on their recommendations.  Refer to the remainder of this document for these recommendations. 

Response:  ﻿EPA thanks commenters for their support of the general approach and efforts to automate the manifest.  EPA has modified its proposed e-Manifest approach based on stakeholder feedback, on continued Agency research and analysis, and on the requirements of the Electronic Hazardous Waste Establishment Act (e-Manifest Act) that was enacted in October 2012.  Please refer to specific EPA responses to learn more about these changes.

	1.2	EPA Collaboration With Stakeholders

Comment:  We heard from 11 commenters that encouraged EPA to continue to coordinate its efforts with the U.S. Department of Transportation (DOT) (Commenter Nos. 1, 11, 16, 17, 21, 22, 23, 24, 25, 26, and 27).  One commenter stated its belief that, without DOT's participation and emergency worker access to the system, trucks should be required to have paper copies of the manifest onboard (Commenter No. 1).   One commenter suggested that EPA allow, under certain circumstances, the e-Manifest to replace DOT requirements for shipping papers (Commenter No. 11).  The commenter believes this should be a limited allowance, but if a transporter meets certain requirements, the electronic manifest should satisfy DOT requirements for a shipping paper accompanying the load.  Another commenter stated that, in light of the information included on a DOT shipping paper, any electronic system should enable regulatory agencies to directly obtain additional information from treatment, storage, and disposal facilities (TSDFs) and generators, thereby obviating the need for a separate hazardous waste manifest to accompany the transportation of hazardous wastes (Commenter No. 16).  The commenter believes that, instead, the electronic manifest system should include the functionality to allow generators to print a shipping paper that complies with the DOT requirements at 49 CFR Part 172.  Another commenter stated that, for manifests that are filed electronically, EPA should address the issue of what documentation needs to be in the possession of the truck driver (Commenter No. 23).  The commenter pointed out that transporters must currently be in possession of a copy of the paper manifest and that documentation provides the necessary identifying information about the type of waste and serves other purposes. Two of the commenters stated that EPA should coordinate with DOT to use the e-Manifest system instead of them requiring a hard copy in the transport vehicle (Commenter No. 24, 25).   One commenter stated that EPA should require a hardcopy manifest be carried by the transporter even if the manifest is automated (Commenter No. 26).  The commenter stated that the disposer's hardcopy manifest is often the one on which negotiations and markups are made, which may therefore be different from the generator's copy.  The commenter would like for the hardcopy manifest, with markups, to be submitted to the central repository or directly to states.

Response:  EPA thanks commenters for their suggestions to continue our efforts to coordinate with DOT.  While it is the intent of EPA's final e-Manifest rule to eliminate as far as possible the reliance on the preparation and retention of paper records in connection with tracking hazardous waste shipments, it is not possible at this time to eliminate all paper documents that are required in the course of transporting hazardous wastes.  As we explained in the May 22, 2001 proposed rule (see 66 FR 28268), it will still be necessary to carry a printed copy of the electronic manifest on the transport vehicle during the transportation of hazardous wastes that are subject to the hazardous materials regulations, since DOT hazardous materials regulations (HMR) require that a hard copy of a shipping paper be carried on transport vehicles for shipments of hazardous materials, unless otherwise excepted.  For shipments that involve state-regulated wastes subject to a manifest requirement rather than RCRA-regulated hazardous wastes, EPA is clarifying further that consistency in the use of the manifest under RCRA also requires that a print-out of the electronic manifest must be carried on the transport vehicle during the transportation of these state-regulated waste shipments.  The adoption of the electronic manifest option in the final rule does not alter or eliminate the existing DOT hazardous materials requirements and RCRA section 2003 consistency provisions respecting shipping papers and the manifest.  In response to these comments, and after consulting with DOT, the Final Rule retains the requirement that to the extent the HMR applicable to the carriage of hazardous materials by public highway requires shippers of hazardous materials to supply a paper document for compliance with 49 CFR section 177.817, a generator originating an electronic manifest must also provide the initial transporter with one printed copy of the electronic manifest.  The Final Rule also requires the transporter(s) to carry this printed copy on the transport vehicle in accordance with the HMR. 

The requirement for the transporter to carry a printed manifest is found at 40 CFR 263.20(a)(4)(iii) of the final rule. While the requirement to continue to supply a printed copy of the manifest for the transport vehicles may appear to frustrate somewhat the attainment of a totally paperless manifest system, we have strived in the rule to minimize as far as possible the requirements for carrying and maintaining paper documents.   Despite the continuing need to supply this printed copy of the electronic manifest, we believe that there will still be substantial reductions in paperwork burdens and forms/data processing costs for manifest users and regulatory agencies as a result of this final action.

Finally, EPA notes that DOT was recently directed by statute to conduct a pilot program addressing electronic shipping papers, but at this time, it is not clear whether and when this program (HM-ACCESS) will be implemented as a paperless requirement.  EPA is consulting with DOT on its progress with the possible transition to electronic shipping papers.  At such time as DOT implements an electronic shipping paper, an entirely paperless shipping and tracking document will be possible for hazardous waste shipments.

Comment: We heard from five commenters recommending continued stakeholder input or collaboration to assist EPA in developing the e-Manifest approach (Commenter Nos. 6, 12, 18, 21, and 27).  One commenter indicated that its company has developed tracking software for producing manifests (Commenter No. 6).  It indicated its desire to speak with EPA about its products, abilities and experiences.  Another commenter expressed its concern that EPA is delaying its decision of which third party will implement the program, thereby making it impossible for the regulated community and others impacted by the rule to assess issues that are critical to compliance (Commenter No. 12).  The commenter suggested that EPA make its selection of a third party available for public comment. Another commenter encouraged EPA to include the Department of Defense manifest users and other stakeholders in discussions leading to the final e-Manifest approach (Commenter No. 18).  Another commenter suggested that EPA promptly convene a logistics workshop and advisory group including hazardous waste generators, transporters and treatment, storage and disposal facility owners to identify and resolve system issues, and to be available for advice and technical assistance when implementation issues arise as the system is initiated and first used on a widespread basis (Commenter No. 21).

Response:  EPA thanks commenters for their suggestions for continued stakeholder involvement and offers for assistance.  EPA agrees with the need for on-going stakeholder involvement, and this has been a motivating factor behind the many outreach efforts EPA has taken to involve the public in our decision-making on the e-Manifest approach.  This has included, for example, the proposed rule in 2001, public notices that requested comment and made information available, a two-day public meeting in 2004, a public meeting in November 2008 with a subsequent series of stakeholder webinars, three System Requirements meetings with stakeholders in February - March 2013, and other outreach (e.g., EPA presentations at conferences, EPA web site that is kept up-to-date on the Agency's activities and decisions).  From these efforts, we believe we have communicated a great amount of information and gathered significant feedback on the needs and desires of the regulated community, regulators, and the public generally.  We believe we have given the public ample opportunity to provide comment on our preferred regulatory and systems approach to date, and we will continue to do so.

In addition, we will involve stakeholders closely in the development and implementation of the preferred approach.  The Electronic Manifest Establishment Act directs EPA to establish within three years of enactment of the Act, an Advisory Board under the Federal Advisory Committee Act (FACA) consisting of an EPA Chair and several others with IT expertise who are either manifest users from the regulated industry or state agency officials who collect and process manifest data.  The Act requires the Board to meet annually to advise EPA on the effectiveness of the e-Manifest system and to make any recommendations to EPA about the system.  Moreover, as required under the Electronic Manifest Establishment Act, EPA will periodically prepare financial statements, accounting reports, and audit reports for the Board, the Agency's Office of Inspector General, and for the appropriate Congressional committees.  .  

This regular oversight will serve to inform EPA of the needs and desires of users and regulators of the system.  It will keep stakeholders apprised of technical and other issues as they arise, and given them an opportunity to provide input on Agency decisions.  It also will assure users that the collected service fees are being applied appropriately, that fees collected are sufficient (and not excessive) to cover costs incurred, and that the program is providing value to the users and the regulatory agencies.  

When sufficient funding for the system is appropriated, EPA will initiate a federal procurement that will lead to the award of an information technology (IT) contract to develop and operate the e-Manifest system.  This procurement will follow normal federal procurement processes and will not involve notice and comment rulemaking.

Comment: We heard from two commenters that noted the length of time EPA needs to finalize its preferred approach and suggested that it enable railroads to use Electronic Data Interchange (EDI) immediately (Commenter Nos. 19 and 31).  One of the commenters stated that, in the longer term, it would like to see a system which will allow hazardous waste to be handled by railroads in the same manner as all other hazardous materials, except that all information that is required to be on the manifest will be included in the electronic bill of lading (Commenter No. 19).  The commenter suggested that the new hazardous waste manifest system needs to be designed to generate an EDI bill of lading to the railroads as a manifest alone is insufficient and will create rework for the railroads and generators.  The commenter also emphasized its lengthy experience using EDI and offered a demonstration of its EDI capabilities to EPA.

Response:  EPA thanks the commenters for their suggestions on the development of an EDI solution with railroads.  We recognize the existing systems that railroads have in place to conduct their electronic transactions.  We also agree on the need to move forward expeditiously in the development of the preferred approach.   In this regard, EPA does not expect any considerable delay in the development of the e-Manifest system now that the authorizing legislation has been enacted, and this final regulation authorizing electronic manifests is being issued.  The most significant constraint is the appropriation of sufficient funds to develop the system. We are as eager to develop and implement an approach as are prospective users, and hope to have a workable system in place within the next few years.  We also are not convinced in the need for a short-term EDI solution because the preferred option will be implemented within the coming years.  Rather, we look forward to working with the railroad industry and others as we establish a single, national e-Manifest system that will be available to all potential users.  In this regard, we intend to task the e-Manifest system IT vendor to conduct the necessary technical support effort with the rail industry to ensure that the electronic manifest XML schema may interoperate with the EDI-based electronic waybill system now in place for rail shipments.

	1.3       State Adoption and Roles

Comment:  We heard from three commenters that suggested mandatory state adoption of the e-Manifest system (Commenter Nos. 11, 22, 29).  One of the commenters recommended that any legislative change provide the Agency with preemption authority to implement the e-Manifest (Commenter No. 11). Without the preemption authority, the commenter believes some states could decide not to adopt the approach.  Another commenter stated that there must be uniform implementation in all states, to avoid a patchwork in which some states make use of the system mandatory and others make it optional (Commenter No. 22).  One of the commenters stated that, if one or more states refuse to adopt the e-Manifests, it would severely reduce the use of the electronic manifest on a national level, make the regulation confusing for industry, and not provide the anticipated cost savings from uniform national use of the e-Manifest (Commenter No. 29).

Response: EPA thanks commenters for their suggestions and concerns.  EPA has been persuaded by public comments on the proposed rule, as well as by suggestions from stakeholders at EPA's public meetings and the 2006 notice, that the e-Manifest should be effective, recognized as valid, and implemented consistently in all states.  EPA agrees that development and use of the e-Manifest would not be feasible unless it can be assured that the validity of electronic manifests is recognized in all the states.  The Agency appreciates stakeholders' concerns that optional state adoption could frustrate the successful development and implementation of e-Manifest systems because investments in these systems could be perceived as too risky.

The issue of consistency of e-Manifest implementation among the states was significant enough during the development of this regulation that the Congress included express terms in the e-Manifest Act providing for consistent implementation in all states on the same effective date determined by EPA, and providing for implementation of the program by EPA until the states are authorized to carry out their consistent provisions of state law.  Specifically, section 2(g)(2) of the e-Manifest Act provides that EPA's final regulations carrying out the legislation shall take effect in each state on the effective date specified in EPA's regulation and that EPA shall carry out the electronic manifest final regulations unless and until the authorized state program is fully authorized to carry out the electronic manifest regulations in lieu of the EPA.  Therefore, our final rule  addresses both the public comments on this issue, and codifies the requirements of the e-Manifest Act.

EPA's final regulation  requires that all state programs adopt and recognize the validity of electronic manifests through the provisions of 40 CFR 271.4(c), which addresses state program consistency and the hazardous waste manifest.  This provision states that a state program shall be deemed inconsistent with the federal RCRA program if the state manifest system does not meet the requirements of Part 271.  With the adoption of the electronic manifest in the final rule, EPA will deem it a matter of RCRA program consistency that all authorized state programs must allow for the use and recognize the validity of the electronic manifests obtained from the national e-Manifest system, as required under 40 CFR § 271.4(c).  

In addition, the e-Manifest will be effective in all states on the same effective date that will be identified in the final electronic manifest rulemaking.  EPA explained in the March 4, 2005, Manifest Revisions Rule that the new manifest form and data elements would be effective in all states on the same compliance date of September 5, 2006.  This policy of setting a uniform implementation date is just as important for the electronic manifest as it is for the paper manifest.  The terms of the e-Manifest Act further  require a consistent implementation of e-Manifest in all the states, and § 271.3(b)(4)(i) of the final rule codifies this requirement by providing that all electronic manifest requirements imposed under the e-Manifest Act shall take effect in all authorized states on the same date that these requirements take effect in other states.  The uniform implementation date will be specified by EPA when it issues its e-Manifest Fee Rule prior to the implementation of the e-Manifest system.

Consistent with the e-Manifest Act's provisions on program consistency, the final rule further codifies in § 271.3(b)(4)(iii) that the electronic manifest requirements implemented under the e-Manifest Act shall be carried out by the Administrator in the states until authorized states have received final authorization from EPA to carry out the electronic manifest requirements.

Further, as additional emphasis on the need for full consistency in the implementation of the electronic manifest program, section 271.3(b)(4)(ii) clarifies that all electronic manifest requirements implemented under the authority of the e-Manifest Act shall supersede any less stringent or inconsistent provision of a State program.    There must be full consistency among the states' programs in carrying out the electronic manifest program.

When the e-Manifest final rule establishes the validity of electronic manifests created and transmitted through a national e-Manifest system, the electronic manifest will simply be an optional means for manifest users to obtain and transmit the hazardous waste manifest.  Whether a user completes and carries only a paper manifest (which by itself meets requirements of the Hazardous Materials Regulations of the U.S. Department of Transportation), or completes an e-Manifest and carries an additional paper copy to meet the Hazardous Materials Regulations (HMR) requirements for a shipping document, the user will be in compliance with federal manifest and shipping document requirements that will be effective on the final rule's effective date in all states.  Once the states receive EPA authorization for their RCRA state program electronic manifest modifications, the e-Manifest will also become effective and enforceable as a matter of state law.  However the e-Manifest will be effective as a matter of federal law in all states on the delayed implementation date that will be designated in the e-Manifest User Fee Rule.  The Fee Rule will be issued by EPA shortly before the e-Manifest system is available to users.  The Fee Rule will announce the schedule of user fees for electronic manifesting activities, and announce the consistent implementation date for the system and these regulations. .  

For several reasons, EPA does not expect the states to have difficulty making the transition to the e-Manifest.  EPA believes that  because of EPA's Cross-Media Electronic Reporting Rule (CROMERR) rule (which lays out a framework for electronic reporting and receiving systems across EPA's programs at the federal, state, and local levels), the states have already begun to consider necessary changes to their environmental programs to enable electronic reporting (e.g., statutory and budgetary changes).  In fact, EPA is aware that a number of states have begun implementing electronic reporting under some of their environmental programs in advance of CROMERR's publication.  Also, many states have developed their nodes for receiving electronic information though the Environmental Information Exchange Network, which will be the means by which e-Manifest will deliver electronic manifest data to the states.

In addition, EPA will establish a compliance date that assures a smooth transition to the e-Manifest by both industry and regulators.  As a point of reference, we note that final rules issued under the Hazardous and Solid Waste Amendments of 1984 (HSWA) went into effect in all states immediately after a six-month period following rule publication.  The EPA Regions administered HSWA rules until state RCRA programs got authorized for them.  Thus, there is precedent in the HSWA rule adoption process for a similar type of coordinating and transitioning EPA and state responsibilities under these rules.  

Similarly, states will not be required to obtain authorization of the e-Manifest by the delayed compliance date to be announced by EPA in the Fee Rule.  As described above, the e-Manifest will go into effect under federal law beginning on this date.  States will be expected to obtain authorization within a reasonable period of time thereafter, in accordance with revision adoption milestones spelled our in 40 CFR § 271.21(e) regulations.  

On the other hand, states will be encouraged to adopt electronic manifest program revisions as soon as they are able after the effective date of this regulation, so that there will not be an extended period of Federal implementation by EPA in lieu of the states.  This phased-in approach will give the states time to make necessary changes to their programs for the e-Manifest.  Because of these factors, we fully expect a smooth transition under the e-Manifest approach. 

Comment:  We heard from a commenter that asked if states would be required to comply with the e-Manifest by a given deadline (Commenter No. 18).

Response:  EPA thanks the commenter for the question and refers the commenter to our response above.

Comment: We heard from one commenter that stated that the 2006 notice does not clarify the role of the states under the approach (Commenter No. 22).

Response:  EPA thanks the commenter's input on the role of the states.  Under the final rule, states will perform the same implementation and enforcement and manifest tracking roles that they are currently performing with paper manifests.  The key difference is that manifests will be distributed to the states via the e-Manifest system hub and Exchange Network, rather than through direct mailing of manifest copies to the states by regulated entities.  The e-Manifest will enhance states' ability to access manifest data in a timely and convenient fashion.  

Comment: We heard from one commenter that stated that any federal e-Manifest system which establishes new or additional requirements for states must include federal funding sufficient to pay for those requirements (Commenter No. 23).  The commenter stated that, without some form of assistance to help defray these costs, states may not be in a position to participate in the centralized e-Manifest system.

Response: EPA thanks the commenter for expressing its concerns about the need for additional funding for the states.  As discussed in the responses above, EPA has considerable experience working with the states to develop and coordinate electronic collections under the CDX or equivalent system and Exchange Network.  We are aware of the states' budgetary constraints as well as the need for ensuring interoperability with states' existing data systems.  In designing and operating the e-Manifest system, EPA will strive to minimize the cost impacts on states and industry.  In addition, EPA anticipates that the national operator of e-Manifest will be responsible for coordinating with the states in the collection, review and correction of manifests.  This could potentially offset some of the manifest processing costs currently being borne by states.   EPA expects that these factors should help to minimize cost impacts on the states and the need for incremental funding.  Application interfaces between e-Manifest and state tracking systems will need to be developed by the states.  EPA will explore the availability of grants or other funding sources to assist states in developing their system interfaces with e-Manifest.

Comment: We heard from one commenter that expressed concern about the impact of e-Manifesting and the new centralized system on its state hazardous waste tracking system (Commenter No. 26).  The commenter stated that its state system annually collects and stores one million manifest documents and makes the data and images available to state, federal, and local regulators.  The commenter stated that the national system could cost the state a significant investment for a partial or complete redesign.  

Response:  EPA thanks the commenter for its concerns about the impacts of the national system on its state system.  EPA shares the commenter's concerns about effects on existing state systems.  EPA will conduct outreach with the states as we plan and develop the e-Manifest system so that any adverse impacts on existing state tracking systems can be minimized.  EPA is developing the e-Manifest system to serve as a conduit to these existing state systems, and not as a replacement for these systems. 

1.4	Effects of Dual Paper and Electronic Manifest Systems
      
Comment: We heard from one commenter that stated that the need for its state to maintain a separate manifest system is dependent upon whether EPA will process paper manifests as part of the centralized e-Manifest system (Commenter No. 4).  The commenter strongly encourages EPA to incorporate the processing of paper manifests as part of the national e-Manifest system.

Response:  We thank commenters for their views of the potential for dual systems under the e-Manifest approach.  We agree that this would be an undesirable outcome.  We also agree with the commenter about the processing of the paper manifest.  During the development of this regulation, the Congress also took up the necessity of avoiding dual systems on account of paper manifests continuing to be used.  As a result, the e-Manifest Act provides that EPA can by regulation require the submission to the system (for a fee) of any paper manifests that continue in use after electronic manifests are available.  This final regulation codifies the statutory requirement.  Upon the implementation of the e-Manifest system, EPA will require TSDFs to submit the top copy of paper manifests received and signed by the facility to the national system..  The paper manifest copies will be processed centrally and the data from these forms will be entered into the e-Manifest data repository by the system operator.  Thus, a complete set of designated facility data on waste receipts can be obtained in this manner from electronic and paper manifests without mandating a transition to the use of electronic manifests.  The interests of the states in obtaining a complete set of electronic data will be realized, without imposing significant new burdens on those users who wish to continue to use the paper manifest forms.  

Another way EPA attempts to minimize the need for dual systems is by making the system flexible enough to accommodate manifests accompanying both federal RCRA wastes and state-only wastes.  The paper manifests are currently used in this fashion, and it should be no different with electronic manifests.  Section 2(a) of the e-Manifest Act requires this result by including in the statutory definition of "user" language stating that a user means any "person that is required to use a manifest to comply with any Federal or State requirement to track the shipment, transportation, or receipt of hazardous waste or other material" that is shipped off-site for management. 

The final rule codifies the statutory requirement and enables the electronic manifesting of state-only wastes.  The final rule includes a definition of "user of the electronic manifest system" in 40 CFR § 260.10 which provides that such a user includes any person that is required to use a manifest to comply with any federal or state requirement to track the shipment, transportation, or receipt of hazardous waste or other waste material that is shipped from the site of generation to an off-site designated facility for treatment, storage, recycling, or disposal.   We will design the e-Manifest system to enable this capability.

Comment: We heard from three commenters expressing concerns about the potential need for multiple systems to accommodate both electronic and paper manifests (Commenter No. 5, 15, 25).  One of the commenters encouraged EPA to make the e-Manifest mandatory for users, to alleviate its concerns (Commenter No. 5).

Response:   EPA thanks the commenters for their suggestions.  Please refer to EPA's response above in regard to the need for multiple systems and the regulatory provisions we are adopting to avoid dual paper and electronic systems.  Please refer to EPA's response in Section 2.2 on whether the system should be mandatory for all users.
      
      1.5	Estimated Costs and Benefits

Comment: We heard from seven commenters that agreed that the e-Manifest would result in savings to users (Commenter Nos. 11, 13, 17, 20, 25, 26, and 28).  One commenter suggested that EPA's cost-benefit analysis should address the need of automated transporters to carry a hardcopy shipping paper (Commenter No. 13).

Response:  We thank commenters for their views.  We agree with the comments that the rule has the potential to result in dollar and time savings to users.  In addition, we agree that the cost-benefit analysis should account for both incremental costs and cost savings.  For example, although EPA will procure the applications and IT services to support electronic manifesting on the CDX or equivalent system and Exchange Network architecture, a number of manifest users will still need to make initial investments  -  to provide or acquire the computers or portable front-end devices and network access for entering data to the e-Manifest system, to integrate the e-Manifest system with their existing data systems, etc.  -  before they can leverage the savings that will arise from electronic manifesting.  Large volume users of manifests will likely realize the greatest net savings and therefore possess the greatest incentives to participate in the e-Manifest system.  Moreover, we anticipate that the larger transporters and waste management facilities would be the entities most likely to participate in the initial phases of e-Manifest system implementation, and that these larger entities will likely bring the portable technology to many of the small businesses and generator sites that they service as their customers.  

Comment: We heard from one commenter that expressed its belief that the costs and staff time of the e-Manifest outweigh the benefits to small businesses (Commenter No. 7).  The commenter expressed its support for an approach that enables the transporter to automate the manifest on the generator's behalf. 

Response:  We agree that a number of generators, particularly smaller ones, may not initially find the e-Manifest particularly cost-beneficial.  Generators that initiate only a handful of manifests per year, for example, may not be willing to invest the time to integrate new processes into their business operations.  The final rule recognizes these differences among generators.  It provides that electronic manifest is optional and that generators may continue to use the traditional paper method.  The rule also clarifies that a generator may automate the manifest by using the initial transporter's portable device, in lieu of investing in its own computer equipment.  We believe that the electronic manifest will most likely be implemented in the field in this fashion, that is, by the efforts of transporters who bring mobile devices accessing the e-Manifest system to their generator customers' sites.  This outcome could make e-Manifesting more attractive and available to smaller generators.  The final rule implements this approach by stating at 40 CFR 262.24(b), that generators may participate in e-Manifest on the devices provided by transporters.

Comment: We heard from one commenter that expressed its belief that the preferred approach could have unintended consequences, resulting in increased burden to users (Commenter No. 9).  The commenter stated, for example, that the system could crash, requiring users to find alternative ways to complete and transmit the manifest.  The commenter also believes EPA has not accounted for costs associated with the DOT requirement to carry a manifest on the truck.  The commenter believes EPA should conduct a full cost-benefit analysis.

Response:  EPA agrees that there will be unintended consequences of any new system such as the e-Manifest system.  In any new program endeavor of this magnitude that could affect potentially tens of thousands of waste handlers, there will be unintended consequences.  To help address this concern, EPA has sought, and will continue to seek, ongoing stakeholder input into the planning, system requirements, and operation of the e-Manifest system.  In particular, EPA will establish an Advisory Board consisting of industry and regulator representatives, who will work with EPA to oversee the operation of the e-Manifest system.  Through their continued involvement, we expect to learn about and address such consequences at the earliest practicable time.

We thank the commenter for its suggestion that EPA conduct a full cost-benefit analysis.  We fully agree with this comment and will ensure that our Regulatory Impact Analysis for e-Manifest addresses the major burdens, costs, and benefits associated with the system.    However, as the detailed evaluation of system costs and benefits will not be possible until more is known about the system costs that result from the system procurement and the fees that are imposed under the Fee Rule, EPA is deferring the development of the detailed RIA until the issuance of the e-Manifest User Fee Rule.  This rule will be issued by EPA shortly before the implementation of the system.

Comment: We heard from one commenter that stated its belief that the cost to start up and to maintain the e-Manifest system may be underestimated (Commenter No. 14).  It believes that a $6 million estimate for an industry-wide standardized information technology system may be low.

Response:  We thank the commenter for its views on the costs of the system.  We will continue to evaluate our system alternatives and their cost assumptions as we continue with the system planning, including the Capital Planning and Investment Control (CPIC) process by which we will inform OMB and Congressional appropriators of our funding requirements for the e-Manifest system build.  These updated costs and assumptions will be discussed in the RIA that we issue with the User Fee Rule.

Comment: We heard from one commenter that its biggest concern is the cost burden to the state (Commenter No. 22).  It stated that the Federal Register's cost estimates apply only to states with manifest programs.  However, the commenter believes that all states may need to have access to the system, including states without manifest programs, because of several factors (e.g., interstate transportation of waste).  The commenter believes that the use of fees to recover these costs could be problematic for the industry, some of whom do not currently pay state annual fees. 

Response: EPA thanks the commenter for its suggestions.   As stated in the above responses, EPA will work with its IT contractor to develop and operate an e-Manifest system that minimizes cost impacts on the states.  EPA agrees that all states should have access to the e-Manifest's data, including states that do not currently collect forms. However, the final rule  does not require states that currently lack manifest tracking programs to develop systems to access e-Manifest.  EPA envisions that such access should be relatively straight-forward.  EPA intends for the system to allow various users to request standard and customized reports.  Therefore, states without existing manifest collection processes should still be able to access the system's data.

Comment: We heard from one commenter that expressed its concern about the initial and recurring annual costs of the e-Manifest system (Commenter No. 24).  The commenter stated that, until the system encompasses all parts of the waste shipping and disposal process, there will not be a significant paperwork reduction for the regulated community and there will be an increase in the time and effort it takes to complete the shipping process.

Response:  EPA thanks the commenter for its concerns about initial and recurring annual costs.  EPA envisions that the first generation e-Manifest will provide core functionality for manifesting of shipments, including methods and tools to streamline the manifesting process (e.g., drop-down menus, pre-populated forms, automated notifications and reporting).  As time goes on, EPA intends to integrate additional elements into the system, such as Biennial Reporting, LDR notifications, and other paperwork activities.  Industry users have informed EPA of the potentially significant burden savings associated with these aspects of the system.

	1.6	Authorizing Legislation and Funding

Comment: We heard from a commenter that recommended that any new authority provided to the Agency for contracting the e-Manifest system development and operation allow this process to be open to any interested parties, not limited to a select few companies (Commenter No. 11). 

Response:  EPA thanks the commenter for its request for an open contracting process for developing the e-Manifest system.  We agree with the commenter's request for broad stakeholder and contractor involvement.  

Section 2(e) of the e-Manifest Act enacted in 2012 authorizes EPA to enter into a performance based contract with a term of up to 10 years for the provisions of system related services.  In order to effectuate this authority, EPA has already issued notices to prospective IT vendors in FedBizOpps about the e-Manifest contract opportunity.  We have conducted an Industry Day with prospective vendors, and we have initiated Requests for Information to the contractor community to begin the process of market research.  Now that this final rule authorizing electronic manifests  is being issued, EPA will soon initiate procurement for the e-Manifest system build, once sufficient funding is appropriated.

Comment: We heard from a commenter that took issue with the 2006 notice's suggestion that, if necessary legislation is not forthcoming, the Agency could still go forward with a final rule based on the original decentralized proposal (Commenter No. 20).  The commenter believes that, even if necessary legislation does not pass, a centralized system is still the only viable template.

Response:  EPA thanks the commenter for its views on EPA's taking action in the absence of legislation.  This comment is moot, however, as the necessary enabling legislation for e-Manifest was enacted in October 2012.  The e-Manifest Act authorizes the establishment of a national, centralized e-Manifest system.  Therefore, this is the approach that EPA intends to implement with this final rule and the later system development. 

Comment: We heard from four commenters stating that EPA needs to clarify and/or pursue funding options for the e-Manifest (Commenter Nos. 1, 12, 14, and 27).   One commenter stated that funding options for the transition to an e-Manifesting system must be more aggressively pursued before the proposal is finalized (Commenter No. 1).  The commenter does not believe that states should have to use state taxpayer money to fund a change requested by companies to save industry money.  The commenter stated that funding will be of even greater importance if the e-Manifest system eventually becomes part of the Biennial Report or transboundary waste reporting. Another commenter stated its concern that EPA does not have adequate funding for its proposed e-Manifest system (Commenter No. 12).   The commenter believes that, because of the significant compliance and implementation issues with the e-Manifest system, it would be in the best interest of EPA, the public and the regulated community for the Agency to resolve funding, contractor, and technical issues and make these issues available for public comment.  Another commenter stated that EPA should further evaluate the project funding fees (Commenter No. 14).  Another commenter expressed uncertainty whether EPA or the states would take on the purchase, development, and long-term maintenance costs of the e-Manifest (Commenter No. 27).  The commenter requested more information on the fee structure plan.

Response:  EPA thanks the commenters for their views of funding options.  We agree with commenters in the central importance of project funding.  We are clarifying that the Electronic Hazardous Waste Manifest Establishment Act authorizes EPA to take action to address funding of the system.  Specifically, the legislation, among other things, authorizes EPA to impose and collect reasonable service fees necessary to pay the costs of implementing the e-Manifest system, and to deposit these fees into a special revolving Fund in the U.S. Treasury earmarked for the receipt of these fees. The Act also authorizes the Secretary of the Treasury, upon request by the Administrator of EPA, to transfer to EPA such amounts from the Fund, subject to appropriations, that EPA determines are necessary to pay costs incurred in developing, operating, maintaining, and upgrading the e-Manifest system.  Finally, the Act establishes that fees collected by EPA and deposited in the Fund shall be available to EPA for its use in paying e-Manifest system costs without fiscal year limitation.

The key funding constraint at the time of final rule issuance is the uncertainty about sufficient funding being appropriated for the system build.  Once the system is developed, EPA can require user fees from system users both to offset system development costs and to defray operation and maintenance costs.  Thus, the e-Manifest system will eventually be subject to a sustainable source of funding though user fee collections, but under the Act, the system build must be funded with appropriations. While earlier drafts of e-Manifest legislation considered by the Congress included Share-in-Savings or Share-in-Revenue provisions authorizing the IT contractor to initially fund the system development costs, this authority was not included in the bill that was finally enacted in October 2012.  

EPA is engaging with OMB and appropriators on our projected needs for system funding, and the system development schedule and completion date will be heavily reliant on the provision of sufficient funds by the Congress.  However, we do not agree with the comment that EPA should defer finalizing this rule until the funding situation is more certain.  The rule is being finalized with a delayed implementation date, so there will not be compliance responsibilities in relation to this rule until the funding situation is resolved and the system is developed.
  
Comment: We heard from one commenter that stated that the Share-in-Savings approach is a better contracting method for the e-Manifest system than the usual federal procurement (Commenter No. 20).  The commenter believes that a contactor who invests in the software development to set up the e-Manifest system and then gets paid back by the users if they are satisfied places the risk and reward with the contractor.  The commenter believes the likelihood of success of such a system is infinitely higher than one where EPA would set contracting specifications and then pay a contractor to meet those specifications.

Response:  We thank the commenter for its views of the Share-in-Savings (or Share-in-Revenue) approach.  We agree that a fee-funded approach with IT contractor funding of the initial investment cost is a novel approach to IT contracting, and that it could l incentivize the contractor to accelerate the development of the system, and to develop a system with features that will sufficiently attractive to users to warrant their participation in the e-Manifest system and their payment of service fees.  However, the e-Manifest Act enacted in October 2012 did not authorize this type of contract, and under the Act, the system build must be funded with appropriations.  Therefore, EPA is not able to accept this comment.

Comment: We heard from four commenters expressing support for user fees to operate the system (Commenter No. 5, 15, 16, and 17).  One of the commenters expressed its desire for state programs to be able to continue to charge state fees under state statutes and rules (Commenter No. 15).   Another commenter expressed its agreement with EPA that the costs of the system should be shared by entities that will benefit from it (Commenter No. 16).  The commenter believes that, since transporters are unlikely to play a role in accessing the system, they should not be subject to the cost sharing provisions.  One commenter expressed its support for cost-effective funding through user-fees (Commenter No. 17).  The commenter believes that the imposition of new user fees to fund a national system likely will be offset by a reduction in or the elimination of state fees 

Response:  EPA thanks commenters for their support of the user fees.  Statements offered by manifest users affirmed that the current paper manifest system gives rise to substantial paperwork burdens, particularly for the heaviest users.  The users suggested that they would be willing to pay reasonable service fees as the means to fund the e-Manifest system, if they could also be assured that the collected fees would be earmarked only to the payment of e-Manifest system costs, and not diverted to other program accounts.  These users also stated that they expected that any service fee arrangements, including the collection of fees and the reporting of expenditures, would be handled in a very transparent manner so that it may be demonstrated to the stakeholders that they are receiving value for the fees they contribute to fund the system.  EPA will develop the Fee Rule subsequently to the issuance of this final regulation.  During the development of the Fee Rule, we will examine how and from whom user fees can be most efficiently and equitably collected, and we will examine any impact the collection of e-Manifest user fees by EPA will have on existing state fees.

Comment: We heard from four commenters expressing concerns about the imposition of a user fee (Commenter Nos. 9, 11, 20, 25).  The commenters urged that there be restrictions for the user fees to be used solely to fund reasonable costs for the design, construction and operation of the e-Manifest system.  One commenter expressed its concern that the user fee could be utilized to raise revenue for other programs and cannot support the approach unless proper safeguards are put in place to prevent unnecessary, excessive or unrelated fees (Commenter No. 11).  EPA will publish a notice subsequent to the rule's effective date to announce the user fee schedule for manifest related activities. 

Response: EPA thanks the commenters for their views on user fees.  We agree that the user fees should be devoted to payment for the e-Manifest system costs, and the 2012 e-Manifest Act includes language providing that EPA "shall carry out all necessary measures to ensure that the amounts [of user fees] in the Fund are used only to carry out the goals" related to developing, operating, and supporting the e-Manifest system (see section 2(d)(2)(C) of the Act).  In establishing the fee, EPA will ensure transparency about how the fee levels are established and how the proceeds are being spent.  As we stated in the 2006 notice, we recognize that users of the system would be willing to pay reasonable service fees as the means to fund the e-Manifest system, if they could also be assured that the collected fees would be earmarked only to the payment of e-Manifest system costs, and not diverted to other program accounts.  EPA intends to provide periodic auditing, accounting, and reporting of the finances of the e-Manifest system, including financial statements and an accounting describing fees paid to the Fund and expenditures paid from the Fund for each period of reporting.  This information will be made available to the Advisory Board that will be established to oversee the e-Manifest system, and provided to the EPA Office of Inspector General and to appropriate Congressional committees as required by specific audit and financial reporting requirements included in the e-Manifest Act (see section 2(d)(3)(B) of the Act).  This oversight will serve to assure the affected users that the collected service fees are being applied appropriately, that fees collected are sufficient (and not excessive) to cover costs incurred, and that the program is providing value to the users and the regulatory agencies.  Finally, EPA will publish a regulation subsequent to the issuance of this final rule to announce the user fee schedule for manifest related activities.  The rule will discuss incentives and safeguards to ensure the formulation of reasonable fees.

Comment: We heard from one commenter that user fees should be a reasonable service fee as opposed to a tax (Commenter No. 18).

Response: EPA thanks the commenter for its views and agrees that reasonable service fees would be appropriate.  The statute authorizing EPA to develop and build the e-Manifest directs the Agency to impose and collect reasonable service fees necessary to pay the costs of implementing the e-Manifest system.  EPA will publish a regulation (the Fee Rule) subsequent to the issuance of this final rule to announce the user fee methodology and fee schedule for manifest related activities.  

Comment: We heard from one commenter that the 2006 notice describes that the system would be funded by stakeholder service fees; however, the commenter is uncertain whether state regulatory access would be subsidized by manifesting businesses, or if the states and local governments would also be charged user fees to access the data or reports (Commenter No. 26).  The commenter stated that EPA should make the system available to the states at a low or no fee.

Response:  EPA thanks the commenter for expressing its concerns about the funding need for the states.  EPA envisions that services fees will be imposed primarily on the  "users of the electronic manifest system" (i.e., waste handlers) as defined in § 260.10 of the final rule, and that such fees would be used to pay for the system's operating costs.  As discussed in the responses above, EPA has considerable experience working with the states to develop and coordinate electronic collections under the CDX or equivalent system.  We are aware of the states' budgetary constraints as well as the need for ensuring interoperability with states' existing data systems.  In designing and operating the e-Manifest system, EPA will attempt to minimize the cost impacts on state regulators.  
2.0	Final Rule

	2.1	General

Comment: We heard from one commenter that expressed its support for the simplification of the final rule, leaving the more detailed technical system design and performance requirements for the contracting process (Commenter No. 4).

Response:  EPA thanks the commenter for its suggestion.  We agree that the final rule should be relatively straightforward.  We believe the final rule achieves this goal.  It is intended solely to enable electronic manifesting from a regulatory standpoint (e.g., by clarifying the validity of electronic manifests obtained from and submitted to the system and describing recommended electronic signature methods).  We agree with comments that the regulations should be technology-neutral, so that it will remain relevant as technology advances.  This is the approach that was adopted in the final regulation.

EPA will procure an IT contractor to develop the e-Manifest, which will be hosted on EPA's CDX or equivalent system.  Technical issues associated with the e-Manifest will be resolved during system planning and development. 

Comment: We heard from one commenter that expressed concern that EPA has not addressed issues in the existing manifest regulations that are contrary or inconsistent with the e-Manifest, such as handwritten signatures (Commenter No. 12).  The commenter expressed a general concern that EPA will address important issues without further public comment.

Response:  EPA thanks the commenter for its concerns about resolving existing inconsistencies in the regulations relative to the e-Manifest approach.  The purpose of the final e-Manifest rule is to resolve these inconsistencies and enable electronic manifesting from a regulatory standpoint (e.g., by clarifying the validity of electronic manifests obtained from and submitted to the system and describing recommended electronic signature methods).  

EPA also appreciates the commenter's desire for public comment on the Agency's preferred approach.  The regulatory policies included in this final regulation are based on the e-Manifest Act enacted in 2012, and on the record developed over the three notices published for comment in 2001, 2006, and 2008.  Other aspects of the Agency's electronic reporting policy were established previously in the CROMERR regulation that was issued by EPA after notice-and-comment in October 2005.

We emphasize that stakeholders will continue to be involved in the development of the e-Manifest IT system.  As an initial point, we note that we involved stakeholders in national meetings and webinars conducted in 2008  -  2009, and in additional system requirements gathering meetings in February  -  March 2013.  We will continue to provide information to stakeholders on our website and by other means as we proceed to initiate a system procurement Beyond system development, EPA intends to establish an Advisory Board consisting of industry and state representatives, as required under the e-Manifest Act, , to offer recommendations to EPA on system performance (see section 2(f) of the Act).

Comment: We heard from a commenter that stated its belief that the final rule should discuss emergency response as one of the technical issues that EPA will address in implementing electronic manifesting (Commenter No. 18).

Response:  EPA thanks the commenter for its views on emergency response.  We agree that e-Manifest could be a very helpful tool to emergency responders in the case of an accident involving materials during their transportation, and perhaps for incidents at facilities where wastes have been delivered for management.  In developing our e-Manifest approach, we have kept this in mind.  However, the Agency with primary responsibility for hazard communication to emergency responders is the DOT, which implements that hazardous materials regulations or HMR.  DOT is currently looking into a pilot program (HM-Access) aimed at demonstrating if electronic means for hazard communication can be substituted for the current shipping paper required by the HMR.  EPA will coordinate with DOT and monitor the Department's progress in identifying and implementing such an approach.  In our consultations with DOT on e-Manifest, DOT has urged us to leave in place the requirement that one paper copy of the manifest (shipping paper) be carried on transport vehicles until such time as an electronic shipping paper substitute is identified.  We have accepted this request from DOT in this final rule, as it is not our purpose with e-Manifest to develop an electronic means for hazard communication with emergency responders that might be inconsistent with DOT's HMR program.  Thus, while there may be incidental benefits for emergency responders accessing e-Manifest in the interim, EPA is not developing the first generation e-Manifest system with this purpose in the forefront.  For the first generation system, therefore, we believe that the requirement for the transporter to carry a paper manifest with the shipment will continue to serve an important function for emergency responders.  Nevertheless, the e-Manifest's central repository will be available for access by state regulators and emergency responders during and after a shipment.  In this regard, we believe the central repository could enhance emergency responders' awareness of the types of hazardous waste shipments that are being conveyed on transport vehicles, as well as  information on what hazardous wastes have been recently delivered to hazardous waste consignee facilities   This could help them prepare for and respond to specific emergency situations, while we await the development of a more comprehensive electronic hazard communications approach under the HMR.

Comment: We heard from a commenter that encouraged EPA to develop the simplest of rules that allows electronic as well as paper manifests (Commenter No. 20).  The commenter noted the rapid pace at which technology changes.  The commenter does not believe that EPA, the IT contractor, and industry can wait for rule changes that are needed for technology innovation and development when regulatory amendments take two to three years to complete.

Response: EPA thanks the commenter for its suggestions on the e-Manifest final rule and agrees with the need for simple, flexible requirements.  To this end, the final rule does not prescribe technologies or include rigid requirements.  Rather, it establishes a general legal and policy framework that authorizes the use of electronic manifests as a means to track off-site shipments of hazardous waste from a generator's site to the site of the receipt and disposition of the hazardous waste.  The rule clarifies that electronic manifest documents obtained from the Agency's national e-Manifest system and completed and signed in accordance with the rule's provisions, are the legal equivalent of the paper manifest forms that are currently authorized for use in tracking hazardous waste shipments.  See the final rule for additional information.

Comment: We heard from one commenter stating that it must be mandatory that any designated facility, which includes TSDFs, submit data for any waste received on-site by specified time frames (Commenter No. 15).  The commenter stated that, without this designation, its state program would still require the submittal of the paper manifest to the state to be assured that all data was collected.

Response:  EPA thanks the commenter for its suggestion.  The regulatory workgroup and the Congress became aware of this concern, with the result that the e-Manifest Act authorized EPA to require by regulation that any paper manifests in use after the implementation of e-Manifest also be submitted to the system for data processing purposes.  The Act further authorized EPA to assess a reasonable user fee for the processing of any such paper manifests.  The e-Manifest final rule codifies this requirement of the Act and provides that the designated facility must send to the e-Manifest system the top copy of the paper manifest form within 30 days of delivery of the hazardous waste shipment.  The copy could be mailed to the e-Manifest system, or EPA may authorize the designated facility to transmit an image file to the EPA system so that the system personnel could key-in the data from the image files to the data system.  Alternatively, the designated facility may be able to submit both the image file and a file presenting the manifest data to the system in image file and data file formats acceptable to the e-Manifest system operator and supported by EPA's electronic reporting requirements.  In any case, the final rule assures that there will be a complete set of manifest data in the e-Manifest system, so it will not be necessary or permissible for states to require their own paper manifest submittals.  

	2.2	Voluntary or Mandatory Use of e-Manifest

Comment: We heard from 21 commenters expressing their belief that the e-Manifest system must be voluntary for users (Commenter Nos. 2, 3, 4, 7, 8, 9, 11, 12, 13, 14, 15, 18, 19, 20, 21, 22, 23, 25, 26, 29, and 30).  Two commenters stated that many small businesses do not have access to the Internet or computer technology available for manifesting (Commenter Nos. 2, 8).  One commenter stated that, if the e-Manifest is mandatory, EPA should re-open the issue of user fees because fees could be difficult for small entities to pay (Commenter No. 7).  Four of the commenters stated that use of the e-Manifest be voluntary, at least at the outset (e.g., until specific metrics are met or bugs are worked out) (Commenter No. 11, 20, 21, 22 ).  One commenter stated its support for a voluntary system and that, if the system were mandatory, EPA would need to design the system to connect with users' legacy and future IT systems with minimal start-up costs (Commenter No. 14).  One commenter stated that the railroad industry has been using EDI for many years and requested that any changes required to accommodate the new electronic system allow adequate time to implement (Commenter No. 19).  The commenter expressed its desire for at least two years to implement any required changes to EDI; however, this would not be an issue as long as EPA makes electronic submission an option.  One of the commenters urged that significant efforts should be made to reach out to small businesses and work with them to develop the capabilities and secure the resources necessary to make a smooth transition from a paper to an E-manifest system (Commenter No. 25).   The commenter suggested creation and implementation of an E-manifest partnership program.  One commenter agreed that the e-Manifest should be voluntary; however, the commenter encouraged EPA to provide incentives to encourage its use, which could eventually lead to a mandatory e-Manifest requirement (Commenter No. 29).  This commenter suggested that one possible solution to capturing the manifest data electronically for non-automated generators would be to require the destination hazardous waste management facility to enter the manifest information into the electronic manifest system at the time it receives the hazardous waste.

Response:  We thank commenters for their views on whether the e-Manifest should be voluntary or mandatory.  We are persuaded by the points raised by commenters who supported the position that the use of the e-Manifest system should be voluntary rather than mandatory.  These arguments were also persuasive to Congress, which enacted the e-Manifest Act with a "user" definition that acknowledged that the use of electronic manifests would be at the election of the users (see section 2(a)(5) of the Act).  We agree with the commenters who suggested that there may be many businesses, particularly small businesses that will not have the willingness nor economic incentive to participate in the e-Manifest system, at least initially  While many small businesses may be able to participate in the e-Manifest system through the efforts of the transporters or designated facilities with whom they contract for transportation or disposal services, we agree that this outcome should be influenced by market factors rather than mandated.  We agree that there are many such businesses that interact with the manifest infrequently for tracking small quantities of waste materials.  These persons should have the option to continue to use the paper manifest form with which they are familiar and comfortable.  In addition, while we agree that a complete set of electronic waste receipt data from designated facilities would be advantageous, we also believe that this objective can be attained through other means than mandating use of the electronic manifest format.  The proportion of manifests completed electronically should increase over time without a mandate, so that the amount of effort expended collecting and processing paper manifests should become less significant and more manageable.  Therefore, consistent with the e-Manifest Act, the final rule adopts in the rule's § 260.10 definition of "user of the electronic manifest system," the policy of implementing the electronic manifest as an optional tracking document for the manifest users in the RCRA regulated community. Users may "opt out" of the electronic manifest, although no particular type of notice is required to exercise such an opt out.  The continued use of paper manifests is sufficient expression of intent to opt out.  However, EPA wants to maximize over time the use of electronic manifests, and the Agency will monitor the levels of use and take input on fee incentives and other means to promote the greater use of electronic manifests.  We will discuss such incentives as we develop the Fee Rule.	

Comment: We heard from three commenters expressing their belief that the e-Manifest system must be mandatory for users (Commenter Nos. 5, 16, 24).  A commenter stated that, if the system were voluntary, its state program would be forced to maintain separate systems for paper and electronic manifests, increasing its costs (Commenter No. 5).  The commenter also expressed concern that, if the e-Manifest were voluntary, the centralized CDX or equivalent system database would not contain complete manifest data.  Another commenter stated that the presence of two separate systems could result in an unnecessarily complicated approach (Commenter No. 16).

Response:  We thank commenters for their views on whether the e-Manifest should be voluntary or mandatory.  Please refer to the EPA response above for EPA's rationale why the system will be optional for users, and why it will not be necessary to mandate the use of electronic manifests in order to develop a complete set of manifest data.

Comment: We heard from one commenter that suggested a mixed approach: require the e-Manifest for large quantity generators and other targeted audiences; allow for exceptions from the e-Manifest for large quantity generators (LQGs) that have a legitimate reason for not participating; and allow voluntary participation for all others (Commenter No. 27).  The commenter stated that its state has used such an approach.

Response:  We thank commenter for its views on whether the e-Manifest should be voluntary or mandatory.  Please refer to the EPA response above for EPA's rationale why the system will be optional for users.  While we appreciate the suggestion about an exception system based on generator class, we are not convinced that the size of the generators' waste generation rates will be rationally related to e-Manifest use, as it may well be the participation of transporters that is the more critical factor in promoting electronic manifest use by many generators.  We also are concerned that the administrative process needed to consider and grant such exceptions may be inefficient for EPA to administer.  Thus, the final rule adopts an "opt out" policy that is not conditioned on any user's request or on a formal exception process.

3.0	Conceptual Design of E-Manifest

	3.1	Extensible Markup Language (XML)

Comment: We heard from one commenter that indicated that its organization is involved with the railroad industry to develop new XML schemas for the industry (Commenter No. 19).  It offered to collaborate with EPA in designing a schema for the e-Manifest in an approved X12 format.

Response:  We appreciate the commenter's feedback on the railroad industry's efforts to develop new XML schemas.  We agree with the comment to coordinate with the industry in designing the XML schema for the e-Manifest system.  EPA will task the e-Manifest system IT vendor to conduct the necessary technical support effort with the rail industry to ensure that the electronic manifest XML schema may interoperate with the EDI-based electronic waybill system now in place for rail shipments.

      3.2	Technical Standards - General

Comment:  We heard from eight commenters generally on the establishment of technical standards for the e-Manifest (Commenter Nos. 10, 12, 15, 21, 22, 24, 26, and 27).  One commenter suggested capabilities for identifying non-compliances with the existing hazardous waste regulations, such as when a conditionally exempt small quantity generator ships more waste than its generator status allows it to generate or accumulate (Commenter No. 10).  Two commenters expressed the need for EPA to address many of the technical requirements for the system, such as how errors and inaccurate data can be corrected (Commenter No. 12, 24).  One of the commenters also expressed concern that EPA has not addressed the need for a standard maintenance "window," during which the system needs to be in operation continuously (Commenter No. 12).  One commenter expressed its support for the e-Manifest system and controls for rigorous performance standards, such as edit checks, error checks, automated tracking of data elements, and maintenance of an electronic image (Commenter No. 15).   One commenter expressed its opposition to any e-Manifest that is generated as a duplicate but not a copy of the original (Commenter No. 15).  The commenter stated that, since the generator is required pursuant to 40 CFR 262.21(a)(1) to obtain a manifest from an approved printer, any e-Manifest data and image that is submitted to the centralized system must stem from that paper manifest.  One commenter identified several technical issues that need clarification (e.g., accessing, tracking, storing and auditing manifest information where one or more of the waste handlers are not using electronic manifesting) (Commenter No. 21).  The commenter also stated its concern about the possibility of uneven use of the electronic system, in which some entities use the e-Manifest and other do not for the same shipment.   The commenter noted the possibility that mark-ups could be made on one entity's manifest that does not show up on the others.  The commenter urged EPA to resolve this issue before beginning design of the electronic system.  One commenter offered to work with EPA to develop the e-Manifest system, based on the commenter's experience developing and operating its state tracking system (Commenter No. 26).  The commenter emphasized the need for quality controls, retention of electronic images of the manifest with signatures, and compatibility with existing state systems.  One commenter cited a number of technical issues that need to be clarified for users in its state, including procedures for user sign-up, as well as procedures for system usage, technical support/problem resolution, data retrieval, compatibility with in-house systems, chain-of-custody, and data corrections (Commenter No. 27).  The commenter also expressed an interest in the technical aspects of the initial release of the e-Manifest system (e.g., discrepancy reporting capabilities, data access by regulators).

Response:  EPA thanks the commenters for their many suggestions for technical requirements for the e-Manifest.  As discussed in the 2006 notice, EPA's preferred approach is the establishment of a national e-Manifest system to be hosted by EPA and funded by service fees that would be paid by the waste handlers who choose to use electronic manifests.   As the final rule explains, one of the great advantages over the national system approach relative to our decentralized approach proposed in May 2001 is that the final regulation no longer needs to concern itself with detailed technical standards.  Instead, the final rule provides a fairly simple legal and policy framework for e-Manifest, clarifying that electronic manifests that are obtained from, signed, completed, and submitted to the system as required by the final rule's conditions, are the legal equivalent of paper manifests.  The final rule aims to be technology neutral by avoiding the codification of detailed security or other technical requirements.  Thus, the final rule renders moot most of these comments asking EPA to resolve many technical issues in this regulation.  Instead, EPA will consider and resolve the system's many technical issues in the system planning, procurement, and development phases of the project.

As regards information security, the system security requirements for the e-Manifest will be planned and addressed under the security planning requirements that apply to all federal information systems.  The federal security planning requirements will produce a detailed set of requirements and controls appropriate to the security impacts of e-Manifest, and these requirements and controls will be implemented when the Agency awards a contract to an IT vendor to build and operate e-Manifest.  The federal information system security planning requirements and process are set out in several publications of the National Institute of Standards and Technologies (NIST).  Taken together, these publications describe a well thought out and understood process for determining appropriate security controls, for monitoring the effectiveness of the controls and identifying vulnerabilities and needed corrective actions, and for periodically certifying and accrediting the security of an information system.  

Having said this, EPA agrees with commenters' suggestions for controls and user support to ensure manifest quality and minimize noncompliances.  We agree that the user procedures (e.g., for registering for and using the e-Manifest system) need to be clearly stated so there is no confusion.  We agree with the comment that EPA needs to minimize disruptions and downtime in the e-Manifest system so that users and others (e.g., regulators) can rely on it.  These comments will be addressed through the system planning and development process described above.  

We appreciate the comment that the existing regulations do not support use of the electronic manifest.  EPA's final rule on the e-Manifest addresses these regulatory gaps and inconsistencies in the existing regulations by prescribing the legal and policy framework for the use of valid electronic manifests.  For example, it states the procedures under which an electronic manifest can be initiated and clarifies such issues as electronic signatures.  It also establishes the legal equivalence of the electronic manifest to the current paper forms.  It states, for example, that electronic manifests that are obtained, prepared, and transmitted in accordance with applicable requirements, and used as specified in lieu of EPA Forms 8700-22 and 8700-22A shall be considered the legal equivalent of paper manifest forms bearing handwritten signatures, and shall satisfy for all RCRA purposes any requirement in the regulations to obtain, complete, sign, carry, provide, use, or retain a manifest. The HMR requirement to carry a paper copy of the manifest (shipping paper) on the transport vehicle continues in place in the interim, pending DOT's evaluation of electronic means for hazard communication involving hazardous materials shipments.
      
We appreciate the comment about the uneven use of the electronic manifest if some handlers in the shipment use the electronic manifest and others do not.  The final rule addresses this comment.  It clarifies, for example, that a generator may prepare an electronic manifest for the tracking of waste shipments involving any RCRA hazardous waste, if it is known that all the handlers named on the manifest can participate in the electronic manifest.  Therefore, the rule establishes the minimum expectation that the initiator of the manifest, the final recipient of it, and all transporters named on the manifest, must participate.  EPA believes this will preserve the essential chain-of-custody aspects of the paper manifest system.  It also includes procedures to follow when access to the system is interrupted and a paper replacement manifest must be provided to complete the transaction.  We believe these procedures will ensure accountability throughout the use of the electronic manifest.  

      3.3	Access Controls/Protections over Data
      
Comment: We heard from seven commenters that expressed the need for regulator access to e-Manifest records (Commenter Nos. 1, 2, 10, 20, 22, 26, 27).  One of the commenters stated that access controls must allow any emergency responder or any RCRA inspector to view the data without restriction (Commenter No 1).  The commenter stated that, if emergency responders and RCRA inspectors are to use the centralized system to access electronic records instead of viewing paper records on the vehicle or on-site, wider access to the system will be necessary than is implied in the 2006 notice.  Another commenter stated that manifest data must be readily available to state hazardous waste inspectors (e.g., during the inspection) (Commenter No. 2).  The commenter was uncertain if state regulators would be required to pay to access it.  The commenter expressed concern that fees for states to access the system would be a difficulty.  Another commenter conveyed the concern of its state inspectors that they may not have access to a site's e-Manifest records during an inspection (Commenter No. 10).  They are uncertain what recourse they would have, for example, if the site does not have a computer.  Another commenter believes the states should not collect the manifests, but access the central repository for them (Commenter No. 20).  Another commenter stated that, if EPA allows businesses to stop retaining paper manifest copies for three years, its state program would need an assurance that local or state inspectors would have access to the manifest data or images (Commenter No. 26).  The commenter stated that government regulatory users should not be subject to a service charge and asked for clarification of this.  The commenter also said it is imperative that the state have unimpeded access to the centralized system in order to facilitate the collection of fees.  Another commenter recommended that, even in the early versions of the e-Manifest, data be made available for downloading and analysis by the states (Commenter No. 27).  The commenter believes this would allow the states to review a variety of information (e.g., what wastes were sent to which receivers by a particular generator during a designated timeframe).

Response:  EPA thanks commenters for their views on regulator access to electronic manifest records.  In the final rule, EPA clarifies that we will design the e-Manifest system with access restrictions aimed at ensuring the security and integrity of electronic manifest data while manifests are being prepared and transmitted within the e-Manifest system.  During the time that waste shipments are en route to the receiving facilities, and during the period of time (90 days after delivery of waste) when manifest exceptions, discrepancies or corrections may be reported, unless otherwise required by federal law, EPA intends to restrict access to manifest records to only the facilities involved with a shipment and to regulators and emergency responders.  These are the entities who have a need to know about the manifest data being entered on an electronic manifest while the shipment is en route, or while the manifest data is subject to revision during the time for reporting waste receipts, exceptions, discrepancies, or corrections  Under current manifest requirements, waste receipts must be reported to the generator by the designated facility within 30 days of the delivery of the waste to the designated facility, and any significant discrepancies must be reported to EPA or the authorized state if the discrepancy is not resolved between the generator and designated facility within 15 days from receipt of the waste as provided by  40 CFR 264.71(a)(4) and 264.72(c).  In addition, the existing regulations provide that exceptions must be reported by generators to EPA or authorized states if 45 days have passed since delivery of the waste to the initial transporter, and the generator has still not received the final copy of the manifest signed by the designated facility.  

These events and the need to verify and correct manifest data affect the finality of manifest data.  Therefore, unless otherwise required by federal law, EPA will restrict access to electronic manifests until the time has passed (i.e., 90 days after delivery to the designated facility) after which the manifest data may be considered final and complete.  While the waste shipments are en route and until the passage of this 90-day period, only the specific waste handlers named on the manifest as having a role in managing the waste shipment shall have access to the electronic manifests, since EPA believes it is important for data security to ensure that only these facilities may access the manifest and make the required data entries to complete the manifest and verify the receipt of the waste or to report exceptions or discrepancies.  Federal, state, and local regulators and emergency responders may also access electronic manifests on the system at any time for purposes of monitoring compliance with the manifest regulations and of discharging their emergency response activities with respect to hazardous waste shipments.   However, after this 90-day period has passed, such that the electronic manifests are considered complete and final for regulatory purposes, the manifests shall be considered public records that may be released to the public upon request in accordance with the Federal Freedom of Information Act, 5 U.S.C. §552.  EPA has included new language in 40 CFR §260.2(c)(2) to clarify this time-limited restriction on access to electronic manifests.  EPA emphasizes that this limited restriction on access is intended to protect the integrity and security of manifest data during the period of time that the electronic manifest is being completed and verified by the waste handlers that are involved with the management of the waste shipment.

Comment: We heard from a commenter that expressed concern that regulator access to waste shipment information could constitute an unannounced inspection of site records and could result in notices of violations being issued for errors found based on those records reviews (Commenter No. 24).  The commenter suggested that access by regulators must be controlled or limited or not be used for "inspection" purposes, or else given due notice by a regulator prior to their inspection of any waste shipping or disposal records.

Response:  EPA thanks the commenter for expressing its concern about regulator inspection of electronic records.  As an initial matter, EPA is not aware of restrictions against regulators conducting unannounced inspections of data that are not otherwise available to the public.  As it currently stands, a large number of the states already collect manifest copies from waste handlers that ship within or to their state.  EPA is not aware that inspector access to these current state manifest collections has been restricted, and we do not see a reason for electronic manifest access to be handled differently by the national system.  Many states are already involved in conducting QA of manifest data submitted to the states, and we believe that the states are generally aware that there are inadvertent errors that occur with the reporting of these data, and that these states attempt to correct such errors rather than pounce on them unannounced for purpose of enforcement actions.  However, EPA believes that the possibility of state oversight and enforcement in appropriate cases provides a useful deterrent against inattentive or intentional misreporting of manifest data.    

Therefore, EPA does not agree with the comment and we decline at this time to restrict regulator access in the manner suggested.  The electronic manifest is intended to benefit all system stakeholders, including RCRA regulators involved in enforcement and compliance monitoring activities.    
Comment: We heard from one commenter stating that EPA needs to clarify access controls and make them available for public comment (Commenter No. 12).  The commenter stated that non-generators should not be able to alter the generator's manifest.

Response:  EPA thanks the commenter for asking for clarification to access controls on manifest data.  As the commenter requests, EPA will develop controls on manifest data access and corrections during the system development process.  This is not an issue that will be address in this non-technical regulation.

Comment: We heard from one commenter stating that its facility has multiple management contractors and each with multiple subcontractors (Commenter No. 24).  The commenter believes access to its manifest records must be available to personnel on a site-wide basis (e.g., to enable site-wide reporting).  The commenter suggested that EPA needs to limit access by EPA Identification Number, not by waste shipper/offeror.  The commenter believes the e-Manifest system must allow individual sites to determine who at their sites needs access and assign the level of access needed for each person.

Response:  EPA thanks the commenter for offering its position on the need for users to tailor access to the particular manifesting practices at their site.  We agree that such flexibility needs to exist in the e-Manifest system.  We will attempt to address this comment as appropriate during the system requirements gathering and design phases of the project..  This is not an issue to be resolved in this non-technical final regulation.

Comment: We heard from two commenters expressing opposition to protections over manifest data (Commenter Nos. 1 and 26).   One commenter stated its belief that nothing in the e-Manifest system should be allowed to be held confidential under any circumstances (Commenter No. 1). The commenter stated that more than one company is typically involved in the transactions, and when generators, transporters, and facilities all share information, the manifest is no longer confidential.  The commenter also stated that emergency responders need access to all the information.  Another commenter stated that all manifests are available to the public in its state (Commenter No. 26).

Response:  EPA thanks the commenters for their views on confidential business information.  EPA agrees that neither individual manifests nor aggregate manifest data should be treated as CBI. 

In regard to individual manifests, the Agency believes that any CBI claim that might be asserted with respect to individual manifest records would be extremely difficult to sustain under the substantive CBI criteria of 40 CFR Part 2, Subpart B and of 40 CFR 260.2, because they must be shared with several commercial entities while they are being processed and used, and must be made available to emergency responders.  In addition, as many states now require the submission of generator and/or TSDF copies of manifests, and the data from these manifests are often made publicly available or reported in federal and state information systems, it is apparent to EPA that many manifest records and the information on them linking waste management firms and generators or transporters are already available from a number of states and other legitimate sources. Since the states have had far more experience than EPA with the collection and disclosure of manifests, EPA is persuaded that the states' policies in this area are entitled to some deference.  Finally, EPA notes that members of the regulated industry have generally conceded the point that individual manifests and the data included in them should not be the subject of CBI claims.  

In regard to aggregate manifest data, EPA notes that the e-Manifest system is being developed so that electronic manifests and data are available to the authorized states at the same time they are available to EPA.  EPA understands from state comments and from state responses to surveys and requests for clarification that among the states that collect and track manifests, the policy of many of these states is not to recognize any CBI claims when processing requests from the public for aggregate manifest or waste receipt data.   In addition, EPA cannot objectively determine whether a particular system search or FOIA request would entail the disclosure of a company's customer list.  EPA has not received any significant input from industry to help the Agency with this determination.  These findings do not support the policy of treating aggregated manifest data as CBI in the manner advocated by the regulated industry.  Therefore, EPA's final position is to categorically exclude aggregate manifest data obtained from the e-Manifest system from CBI coverage.

While EPA is rejecting the comments that requested CBI handling of individual or aggregate manifest data, EPA emphasizes that the restrictions on access included in the final rule should mitigate greatly the concern that the e-Manifest system may be data mined by a waste handler's competitors for sensitive customer list information.   Under this final regulation, unless otherwise required by federal law, the system will not provide direct public access to manifest data during the time that manifested waste shipments are "in process," which covers the time that wastes are en route to the destination facility, and a period of 90 days after the receipt of the wastes by the destination facility.  During this period that waste shipments are in process, only the waste handlers named on a particular manifest, RCRA regulators, and emergency responders will be able to gain access to these manifests from the system.  

Commenters advised EPA that current state agency disclosures of manifest data from paper manifest tracking programs do not raise CBI issues for the industry, because it normally takes several months for the states to disclose the data, and by this time, the customer list sensitivity has diminished.  By restricting public access though the system to these data for the transit time and an additional 90 days post-delivery, EPA believes that industry members will likewise be shielded from disclosure of their customer information by the system for several months.  Thus, there will not be the immediacy of data access that troubled those commenters who argued that the immediacy of data mining under e-Manifest was the distinguishing feature that required CBI treatment of e-Manifest information.  

Comment: We heard from three commenters expressing general support for the CBI procedures (Commenter Nos. 10, 11 and 25).   One commenter agreed that CBI claims can be made but stated that CBI claims should not apply to state regulators (Commenter No. 10).  One commenter supported EPA's CBI procedures, but recommended that access to electronic information on manifests be limited to government authorities and the parties involved in a specific transaction for a period of one year from receipt by the destination facility (Commenter No. 11).  The commenter believes a one-year period will ensure the material has been properly recycled, treated or disposed and therefore makes the information useless to any person or organization that could utilize the material for nefarious purposes.  The commenter also believes a similar argument for limiting access until after the first year can be made by industry for competitive reasons as well. 

Response:  EPA thanks the commenters for their views.  Refer to the response above for EPA's rationale for determining the manifests should be not treated as CBI.  We appreciate the comment indicating that the proposed 45 day period of restricted access was insufficient, and that a year of restricted access would be sufficient to deal with competitiveness issues and concerns about interception of waste shipments for nefarious purposes.  In response, we have extended the period of restricted access to the period while waste shipments are "in process," which we interpret as the time that waste shipments are in transit to the destination facility, plus an additional 90-day period measured from the date of receipt by the destination facility.  EPA believes that one year would be too long a period to restrict public access, given that paper manifest data has been generally made available to the public without restriction from state agencies after several months.  With a 90-day period of restricted public access through the system (unless otherwise required by law), the public and the industry members will be no worse off than they are currently in their dealings with the states' disclosure practices, insofar as gaining access to data that could potentially raise competitive concerns if immediately released to the public.

Comment: We heard from one commenter that EPA must consider that some of the Department of Energy information is classified and must be held in a secure depository inside the United States (Commenter No. 24).

Response:  EPA thanks the commenter for its input.  EPA has made a final determination that manifests should not be treated as CBI, for which there is a distinct FOIA exemption  If federal regulations for the protection of classified data apply to manifests, steps will be taken to comply with these provisions.  EPA will need more information from DOE and DOD organizations about their national security/national defense related claims with respect to  manifest data before the Agency  can develop a policy on how such claims should be asserted and processed.  This final rule addresses the FOIA exemption for CBI.

      3.4	System Compatibility

Comment: We heard from two commenters noting that it is essential that any national system be designed to be compatible with the currently existing state systems (Commenter No. 4, 26).  One of these commenters believes that EPA's preferred approach meets this need (Commenter No. 4).  Another commenter expressed uncertainty if the national system will be compatible with its state system and urged EPA to consider states' systems to ensure compatibility (e.g., compatibility for downloading and transferring data) (Commenter No. 26).

Response:  EPA thanks the commenters for their concerns about system compatibility with state systems.  We agree with the importance of such compatibility, and believe the final rule approach will provide a relatively high likelihood for compatibility with both existing state and industry systems.  As discussed in greater detail elsewhere in this document, the e-Manifest will be hosted on EPA's existing CDX or equivalent system computer hub or equivalent system, and will be connected to state governments via EPA's partnership National Environmental Information Exchange Network, on which there are 51 state nodes, 12 Tribal nodes, and 2 Territory nodes.  As of May 2013, all 50 states, 90 tribes and five territories had received EPA Exchange Network grants.

Briefly, the Exchange Network is a secure Internet- and standards-based approach for exchanging environmental data. EPA, state environmental departments, and U.S. tribes and territories are partnering to build the Exchange Network to increase access to environmental data.  In this view, the e-Manifest will be hosted on an existing network that already is connected to, and therefore compatible with, many of the states' systems.  As the final rule indicates, the Agency intends to implement data exchange between e-Manifest and external systems with XML schemas, which are now almost universally used for such data exchange purposes.  The States will only need to develop the appropriate application interfaces between e-Manifest and their existing state data systems, and they will need to have, of course, XML compatible data systems.

Comment: We heard from one commenter that the manifest format needs to be suitable for downloading into an Oracle database so that users will be able to produce site-specific reports (Commenter No. 24).

Response: EPA thanks the commenter for its input. EPA agrees that the e-Manifest should be compatible with users' existing systems and software.  The Agency intends for the e-Manifest to offer users with a range of options for downloading data and/or producing standardized or customized reports.  

	3.5	System Security

Comment: We heard from one commenter that asked for EPA to re-examine the security of the e-Manifest system (Commenter No. 9).  It expressed concerns about lost or stolen data and the potential inappropriate use of data by authorized or unauthorized users.  Another commenter stated that, with the appropriate expertise, a user could initiate an e-Manifest that fraudulently indicates shipment and disposal of hazardous waste that has never been sent offsite (Commenter No. 10).  The commenter noted, however, that this would require the generator, transporter and TSD to provide fraudulent signatures.

Response:  EPA thanks the commenters for their concerns about lost or stolen data and possible inappropriate uses of manifest data.  We agree with the commenter in the importance of system security.  In developing the e-Manifest, the Agency will address system security controls in accordance with Federal information technology standards and guidance, including NIST's FIPS PUB 200, "Minimum Security Requirements for Federal Information and Information Systems," (March, 2006) and NIST's Special Publication 800-53 Rev. 3, "Recommended Security Controls for Federal Information Systems and Organizations," (August 2009, as updated in May 2010).  These publications specify minimum requirements in 17 distinct security-related areas (e.g., media protection, system and information integrity).  Refer to Section 3.2 of this document for further information on this.
	
      3.6	System Failure

Comment: We heard from five commenters that asked EPA to address system failure (Commenter Nos. 9, 21, 22, 24, 27).  A number of these commenters asked EPA to clarify if a user would be out of compliance if there are problems associated with the system, or if data are lost in the middle of generating the e-Manifest (Commenter Nos. 9, 21, 22).  One of the commenters urged EPA to clarify the consequences of system malfunctions for all participants in the management system, and develop backup systems to ensure unimpeded movement of manifested waste (Commenter No. 21).  One commenter asked for clarification whether facilities still need to hard copy print all the forms for backup, in case of system failures (Commenter No. 22).  One commenter stated the need for back-up systems and accommodations for peak usage and natural disasters and emergency situations (Commenter No. 24).  One commenter asked for clarification on transporter liability if its computer cannot access the e-Manifest during transportation (Commenter No. 27).

Response:  EPA thanks the commenters for their comments and concerns about system failure.  We agree in the need to minimize system downtime.  We also recognize the need to include provisions in the final rule that clarify user liability in regard to lost or corrupted data on the system.  In this respect, the final rule provides that no generator, transporter or designated facility may be held liable for the inability to produce an electronic manifest for inspection if it can demonstrate that the inability to produce the electronic manifest is due exclusively to a technical difficulty with the EPA system for which it bears no responsibility.  We believe these provisions address the commenters' suggestions.  The final rule also includes provisions for transporters (see § 263.20(a)(6) and designated facilities (see §§ 264.71(h) and 265.71(h)) to provide and complete paper replacement manifests in the event the system becomes unavailable for any reason after a manifest has been initiated electronically but cannot be completed electronically.  Thus, the paper copy that is currently required to be carried on the transport vehicles for HMR purposes can also serve as the back-up document for completing hazardous waste tracking activities, in the event the e-Manifest system becomes unavailable while the shipment is en route.

      3.7	Central Repository
      
Comment: We heard from one commenter that stated that reliance on the centralized repository will work only if two conditions are met: 1) The generator has a means, at the location of the site of generation, for retrieval and review of the data; and 2) The paper manifests are maintained on-site for a minimum period of 45 days, which coincides with the amount of time a generator has to file an exception report if they have not received confirmation that the waste was received at the designated facility in the format of a signed manifest since the exception report must include a copy of the manifest (Commenter no. 15).

Response:  EPA thanks the commenter for its input and agrees that, under the e-Manifest system, a generator must be able to retrieve and review the electronic manifest.  Consistent with this view, the e-Manifest final rule provides that a generator may prepare an electronic manifest for the tracking of hazardous waste shipments involving any RCRA hazardous waste only if it is known at the time the manifest is originated that all waste handlers named on the manifest participate in the electronic manifest system.

In regard to recordkeeping of the manifest copy, EPA notes that an electronic copy of the generator's manifest will reside on the system.  Provided that all applicable requirements of the final rule have been met, this copy is equivalent to the paper copy in all respects.  Therefore, the generator need not retain a paper copy of a manifest prepared and transmitted via the system, except as otherwise specified (e.g., for manifests completed with signature devices that are undergoing EPA tests).

Comment: We heard from one commenter that asked if the central repository will satisfy the requirement for waste handlers to maintain copies of the manifests for three years (Commenter No. 22).

Response:  EPA thanks the commenter for its question about the recordkeeping in the central repository.  The final rule provides that any requirement in the regulations for an electronic manifest user to keep or retain a copy of each manifest is satisfied when the user retains a copy of an electronic manifest for the same retention period as required for paper manifest records.  The final rule includes standards that must be met to  comply with the recordkeeping requirements.  For example, it provides that electronic manifest copies are retained by a generator when the generator can store, access, and retrieve all of the generator's electronic manifest records from an account or record collection established for the generator on the EPA Electronic Hazardous Waste Manifest System.  See, for example, the regulations at 40 CFR 262.24(a)(2) in the final rule.

Comment: We heard from one commenter that stated that the central repository should be current and available at all times (Commenter No. 23).

Response:  EPA thanks the commenter for its comment about the central repository.  This is a system design issue rather than a regulatory issue for this final rule to address.  We agree generally that the central repository should be available to users at all times.  Practically speaking, however, we recognize that there are downtimes in any Internet-based system), and there must be occasional downtimes scheduled for system maintenance.  In designing the system, we will take efforts to minimize downtime of the EPA system, in recognition of the need for users to have ongoing access to their manifest data.

Comment: We heard from one commenter that asked if small quantity generators or conditionally exempt small quantity generators would be required to have an EPA identification number to use the centralized system (Commenter No. 18).

Response: EPA thanks the commenter for its question and agrees that each site originating the manifest should have its own unique number, whether it is an EPA identification number, state identification number, or other number.  EPA will determine the most appropriate type of number at a later date.  This is a system requirements and design issue, rather than a regulatory issue to be resolved in this final rule.

Comment: We heard from one commenter that, if a business discontinues use of the e-Manifesting service and could no longer access their data, it would not be able to comply with the three year retention and would be out of compliance, unless the business can download, store, and make available to the regulator their manifest data (Commenter No. 26).  The commenter stated that the system needs to allow for changes in business decisions.

Response:  EPA thanks the commenter for its suggestion about the central repository.  We agree that a user needs to have access to its manifest data for three years, as required in the regulations.  In fact, the final rule provides that an electronic manifest user satisfies the electronic recordkeeping requirement if it can, among other things, store, access, and retrieve all of its electronic manifest records from an account or record collection established for it on the EPA Electronic Hazardous Waste Manifest System.  In a circumstance in which a business discontinues active use of the system, we expect it to maintain access to its manifest records nonetheless, or to arrange to download and store all its records locally.  This could be accomplished, for example, by maintaining its current user account with the e-Manifest system for the remainder of the three-year retention period.

	3.8	Gradual Roll-out/Scalability

Comment: We heard from four commenters that expressed support for the gradual roll-out of the e-Manifest (Commenter Nos. 14, 20, 25 and 30).  One commenter asked EPA to continue to look for opportunities to integrate technology to reduce the cost of compliance and create regulatory flexibility (Commenter No. 14).  In this regard, the commenter supports developing a core system that can be expanded in the future to allow users to submit Biennial Reports and other data gathering.  Another commenter stated that EPA should work out the bugs in the basic system before adding greater functionality (Commenter No. 20).  Another commenter emphasized that, once the system has proven reliable, it should be scalable, providing opportunities to offer additional services in the future, such as biennial reporting (Commenter No. 25).  Another commenter stated that EPA's decision to defer details to the contracting process is a common-sense approach for ensuring that the technical specifications for an electronic manifest system are implemented and developed in the most effective and efficient manner for the regulated community (Commenter No. 30).

Response:  EPA thanks the commenters for their many viewpoints on scalability of the system.  This is a system design issue, rather than a regulatory issue that will be resolved in this final rule.  EPA agrees with comments that the system should be scalable, and that we should develop a system with core functionality before expanding it to the Biennial Report or other enhancements.  We recognize industry's desire for added functionality in the near term, but we have to balance their need against other considerations, including the challenge of developing a new IT system with even the core manifest functionality.  For example, EPA will procure an IT contractor to develop the system, and this contractor will assume upfront risk in developing the system. We are very aware that any prospective contractor will weigh the risks of participation against the potential benefits.  If EPA's approach is too aggressive, it could repel qualified contractors who would otherwise be interested in developing the system.  In addition, we realize that the main purpose of the system is to support the commercial shipment of hazardous waste.  Users of the system will need reliable services to support their commercial activities.  Because of such factors, we believe it is prudent to develop the basic manifest system first and work out its technical difficulties before considering expansions to the system.

Comment: We heard from one commenter that encouraged EPA to develop a robust suite of reporting capabilities in the e-Manifest upfront (Commenter No. 5).  The commenter was concerned that funding may run out before additional reporting capabilities are integrated, if EPA pursues a more gradual approach.  Another commenter stated that the e-Manifest system would not result in benefits to its state program until it is expanded such that data collected through the e-Manifest system can replace the Biennial Report (Commenter No. 27).  The commenter recommends that until the e-Manifest system is updated to capture the information required to generate the biennial report, the e-Manifest system should allow the collection of limited state data (e.g., state waste codes in addition to EPA waste codes), related to the biennial report.  It also recommends that if the e-Manifesting system is made mandatory for everyone, EPA should work with the states in revising the requirements of future biennial reporting.  The commenter also suggests that EPA consider developing alternatives for companies without computers or compatible systems.

Response:  EPA thanks the commenters for their suggestion on expanding the system in the near term.  Please refer to the Agency response above for our rationale for a gradual expansion of the system.  This is a system planning and design issue, rather than a regulatory issue to be resolved in this final rule.  Beyond this, it is important to note that funding of the system will originate from user fees.  It is important to put in place a core system that meets basic shipment tracking needs first, so that this functionality can be promptly implemented, and user fees can begin to be collected so as to stabilize the longer term funding of the system.  EPA expects to set fees that will cover the costs for development, maintenance, and operation of the system, as well as costs for future upgrades.  In this regard, EPA expects funding to be available for system expansions based on the fee system put in place.  Finally, EPA will need to consult closely with the System Advisory Board on the need for and timing of system upgrades and expansions, as these will affect the cost of the system and the level of fees that will need to be charged to recover those additional costs.

Comment: We heard from one commenter that recommended that the implementation of additional services, such as biennial reporting, occur within two years of implementation of the e-Manifest (Commenter No. 11).  The commenter believes these additional features are important to the regulated community and their implementation would bring about additional cost savings, which in turn would drive support for use of the e-Manifest.

Response:  EPA thanks  the commenter for its suggestion on expanding the system. This is a system planning and design issue, rather than a regulatory issue to be resolved in this final rule.  We agree with the comment that added functionality such as for biennial reporting is important to the regulated community, and indeed, the e-Manifest Act includes integration with biennial reporting as one of the measures for ultimate system success.  As stated in the 2006 notice, it is our current intention to expand the system to include such functions after the core system is developed and proven to be in good working order.  However, we cannot predict with certainty when such expansion would occur, as there are too many variables involved.  For example, we cannot predict the growth rate in the use of the core system, and the demands placed on the system.  We also cannot predict the types or complexity of technical difficulties to be resolved in executing a system expansion, or the increased user fees that will be required to fund the expansion.   For such reasons, we do not want to establish a hard and fast deadline for expanding the system's functionality.  That said, we continue to believe that the core system will provide many benefits that will be attractive to users, such as streamlined manifest completion and reporting and associated burden savings.  Beyond this, we fully expect users to find ways to download and manipulate their electronic manifest data from the core system to facilitate their reporting activities.  Therefore, we do not believe that the absence of specific functionalities would necessarily limit users' ability to take advantage of the electronic data for their other reporting needs.

	3.9	Integration of e-Manifest into Existing Regulatory Program

Comment: We heard from one commenter stating that hard copies of the manifest or "official" printouts would have to be available at generator sites so facilities can use them to determine their generator status and to calculate state generator fees (Commenter No. 2). To accurately do this, the commenter believes that facilities must be able to determine their monthly generation rates.

Response:  EPA thanks the commenter for its suggestion on the availability of manifest data.  EPA is clarifying that users of the e-Manifest will have full access to their manifest data in the system.  If they would like to use their manifest data for compliance or other purposes, they should be free to do so, without necessitating the retention of paper copies.

Comment:  We heard from one commenter that that the e-Manifest implementation could be hindered for international shipments because of existing import and export tracking requirements, as well as the regulations in foreign countries (Commenter No. 12).

Response:  EPA thanks the commenter for its views on international shipments.  EPA is clarifying that, at least at the outset, we envision the e-Manifest as a system for domestic shipments.  Therefore, this final rule does not contain provisions aimed at automating the transboundary tracking processes or integrating e-Manifest with other nations' tracking documents.  EPA is not now making arrangements with foreign countries to develop or integrate cross-boundary electronic systems.  EPA also is clarifying that we do not envision automating the manifesting and reporting functions associated with international shipments.  Should the scope of the e-Manifest system be expanded later to encompass these or other RCRA reporting requirements, EPA will provide notice of the change in scope and indicate when it will be prepared to accept the additional reports electronically this regard, we do not envision use of the e-Manifest system in shipping hazardous waste internationally.  For importers and exporters that choose to use the e-Manifest for the domestic portion of a shipment (e.g., for shipping a waste that has already been imported in the country), the e-Manifest system will be designed to be compatible with the manifest completion requirements for international shipments.  Therefore, we do not share the commenter's concerns about the existing import and export tracking requirements.

Comment: We heard from one commenter that stated that no mention of the Acknowledgement of Consent (AOC) was made in the 2006 notice (Commenter No. 19).  The commenter recommends that EPA incorporate an electronic system for the AOC for hazardous waste transported internationally. 

Response:  EPA thanks the commenter for its views on an electronic AOC.  In the preamble to the final rule, we clarify that we do not envision automating the reporting functions associated with international shipments, such as the Acknowledgement of Consent.  Thus, this final rule does not include any provisions that would integrate the acknowledgment of consent for waste exports with e-Manifest.  These and other reports or submissions must be submitted in accordance with the requirements and procedures specified in the specific regulations which describe when these reports are required and how one should supply these records or reports.  Should the scope of the e-Manifest system be expanded later to encompass these or other RCRA reporting requirements, EPA will provide notice of the change in scope and indicate when it will be prepared to accept the additional reports electronically.  This is consistent with our approach to develop the e-Manifest system gradually, i.e., to develop the core domestic e-Manifest system and then expand it as appropriate.  Please refer to the Agency responses in Section 3.8 of this document for additional information on this scalability. 

Comment: We heard from four commenters that are concerned that the new system and associated regulations would not be compatible with the state system (Commenter Nos. 10, 18, 26 and 27).  They encourage EPA to develop a system that addresses state-only wastes, universal wastes, household hazardous wastes, and non-hazardous waste, and is compatible with state reporting requirements.  Without these accommodations, they indicated that waste handlers in their state would have to comply with multiple sets of manifesting and reporting requirements (e.g., federal e-Manifest and state-specific procedures).  One of the commenters stated that TSDFs deal with these wastes in different ways and suggested that clarifications would be helpful (e.g., EPA could include a check box on the manifest to identify the regulated status of the waste) (Commenter No. 10).  The commenter also suggested that EPA clarify how the system will handle manifests from conditionally exempt small quantity generators.  Another commenter stated that limiting the centralized system to strictly RCRA wastes may decrease its cost effectiveness (Commenter No. 18).  

Response:  EPA thanks the commenters for their suggestions for the e-Manifest to encompass state-specific wastes.  We agree with comments that the e-Manifest needs to be a flexible system that can accommodate state-specific wastes for tracking non-federal waste types.  The e-Manifest Act requires that the system be implemented to track both shipments of federal RCRA wastes subject to manifesting and to state-regulated wastes or other materials subject to the manifest requirement under state law.  The final rule codifies this requirement in the § 260.10 definition of "user of the electronic manifest system."  The remainder of these comments that suggest how the system might be implemented to accommodate state wastes or CESQG wastes are system design issues, rather than regulatory issues to be addressed in this final rule.  We will design the e-Manifest system to enable this capability and address these concerns.

Comment: We heard from one commenter that the requirement for the last rail carrier to get a copy of the signed manifest does not seem to have a purpose, other than to place an additional requirement on the rail carrier to maintain another copy (Commenter No. 19).  The commenter suggested that the requirement for the designated facility to provide a signed copy of the manifest to the last rail transported be eliminated. The commenter stated, for example, that the railroads will have a record that they transported the hazardous waste electronically under the new proposed electronic system.

Response: EPA thanks the commenter for its input.  However, at this time, the Agency is not considering regulatory changes that are outside the scope of the e-Manifest project.  In any case, EPA notes that the e-Manifest will significantly streamline users' transmittal and retention of manifest records.  For example, once a transporter signs the electronic manifest, that copy would be retained in the system and serve as the transporter's official copy.  The transporter could then transmit a copy to the next waste handler via the central system or portable device.
	
Comment: We heard from one commenter that asked if the Land Disposal Restrictions (LDR) paperwork needs to be completed and transmitted in hardcopy for an automated shipment (Commenter No. 22).  The commenter also asked for clarification on whether the manifest can be initiated by a broker on behalf of a generator customer.

Response: EPA thanks the commenter for its questions.  EPA envisions that the first generation e-Manifest would not integrate LDR paperwork.  We believe it is important first to successfully develop the core functions of the system.  Hence, during this initial phase, waste handlers would be required to comply with the LDR requirements using hardcopies.  After the core functions are in good shape, EPA intends to gradually integrate other collections into the system as appropriate.  This could include, for example, LDR paperwork.

Comment: We heard from one commenter on its desire for the system to integrate greater functionality with existing reporting requirements, such as the LDR paperwork requirements (Commenter No. 24).

Response:  EPA thanks the commenter for its questions.  As stated in the response above, EPA envisions that the first generation e-Manifest would not integrate LDR paperwork.  We believe it is important first to successfully develop the core functions of the system.  After the core functions are in good shape, EPA intends to gradually integrate other collections into the system as appropriate, such as LDR paperwork.

	
 
Table of Organizations Commenting on the Notice and Commenter Numbers
Commenter Number
Name of Organization Commenting on the Notice
1
Illinois Environmental Protection Agency
2
New Mexico Environment Department
3
API
4
New York State Department of Environmental Conservation
5
Wisconsin Department of Environmental Resources
6
IT Inc
7
Graphic Arts Coalition
8
National Federation of Independent Business
9
IPC
10
Florida Department of Environmental Protection
11
Safety-Kleen Systems Inc.
12
Alliance of Automobile Manufacturers
13
National Paint and Coatings Association
14
The Dow Chemical Company
15
Michigan Department of Environmental Quality
16
American Trucking Association
17
National Automobile Dealers Association
18
U.S. Department of Defense
19
Association of American Railroads
20
Environmental Technology Council
21
Waste Management
22
Virginia Department of Environmental Quality
23
Missouri Department of Natural Resources
24
Oak Ridge National Laboratory
25
Cement Kiln Recycling Coalition
26
California Department of Toxic Substances Control
27
Texas Commission on Environmental Quality
28
U.S. Department of Energy
29
Onyx Environmental Services, L.L.C.
30
Utility Solid Waste Activities Group
31
Alcoa