Incorporation by reference in an open-government age.
INTRODUCTION I. BACKGROUND A. Context: The Public-Private Partnership in Standards B. Process: The Role of the Office of the Federal Register C. Regulatory Uses of Incorporation by Reference 1. Types of Incorporated Materials 2. The Role of Federal Standards Policy 3. The Current State of Standards in Regulation 4. Emerging Issues with Incorporation by Reference II. THE PUBLIC ACCESS PROBLEM A. Threshold Questions 1. To Whom Must Materials Be Reasonably Available? 2. Which Agency Should Ensure Reasonable Availability? B. Evaluating Copyright Claims 1. Fair Use a. The Purpose and Character of the Infringing Use b. The Nature of the Copyrighted Work c. The Amount and Substantiality of the Portion Used d. Market Impact e. The Limited Usefulness of Fair Use to Increase the Availability of Incorporated Materials 2. Public Domain 3. Merger Doctrine C. An Emerging Public Policy Dispute D. Tools to Expand Availability E. Collaborating to Ensure Reasonable Availability III. THE CHALLENGE OF UPDATING INCORPORATIONS BY REFERENCE A. Legal Prohibitions on Dynamic Incorporations B. Technical Amendments to Update Access Information C. Agency Practices That Can Facilitate Updating D. Confining Standards to Appendices and Guidance E. Equivalency Determinations and Enforcement Discretion F. Direct Final Rulemaking G. Statutory Solutions IV. PROCEDURAL AND DRAFTING ISSUES A. Identifying Materials Appropriate for Incorporation B. Standardizing Language and Formatting C. Determining the Legal Effect of Secondary References D. Addressing Potential Conflicts E. Securing Timely Approval from the Office of the Federal Register F. Making the Process Work Better CONCLUSION
The time has come to reevaluate incorporation by reference, a little known but frequently used regulatory practice with profound public policy implications. To give a regulation legal effect, an agency must publish it in the Federal Register for codification in the Code of Federal Regulations (CFR). (1) As a centralized depository of regulatory commands, the CFR provides citizens with actual notice of legal requirements. In this context, incorporation by reference is a term of art for the practice of codifying material published elsewhere by simply referring to it in the text of a regulation. It is permitted only if the incorporated material is "reasonably available to the class of persons affected" and the promulgating agency secures the "approval of the Director of the Federal Register." (2) The legal effect is that the material is treated as if it were set out fully in fine regulation. (3)
Originally intended to reduce the size and improve the readability of the CFR, (4) incorporation by reference has taken on greater significance as the government has embraced the use of voluntary consensus standards in federal regulations. Voluntary consensus standards are technical standards (5) developed by private sector organizations using an open process that respects due process, includes an appeals process, and results in a consensus among participants representing a balance of interests. (6) In the 1970s, federal policy began to prefer that agencies use such standards in regulations instead of creating "government-unique" standards. (7) This policy, now codified in statute (8) and executive directive, (9) allows agencies and the public to reap the significant benefits of collaborative governance through a public-private partnership in standards. (10)
In large part due to this federal standards policy, the CFR today contains over 9,500 incorporations by reference of standards. (11) Many other kinds of materials aside from standards are also incorporated by reference, including government documents and technical publications from nongovernmental sources. The Office of the Federal Register (OFR) roughly and informally estimates that if all incorporated materials were printed out fully, the CFR would be six or seven times its current length. (12)
Despite its ubiquitous use, incorporation by reference in federal regulations has, until now, escaped scholarly examination. (13) Over the years, common issues with the practice have emerged, and individual agencies have labored independently to find solutions. This Article shines a light on the important policy implications of incorporation by reference in a world transformed by open government. It brings together the experiences of various regulatory agencies with the goal of identifying best practices that can improve incorporation by reference.
The greatest challenge of incorporation by reference is that it can erect a barrier impeding access to the law, sometimes even requiring one to pay a private party to see the full text of a final or proposed regulation. This unfortunate consequence arises when the incorporated material is copyrighted, as is often the case with voluntary consensus standards. The traditional solution has been to require OFR and promulgating agencies to keep copies of incorporated materials available for public inspection in agency offices, but this solution is inadequate in an age of open government. Today, widespread use of the Internet, combined with e-rulemaking initiatives and pushes for greater transparency in government, have raised expectations regarding the accessibility of agency processes and regulations. (14) From this perspective, the public access problem posed by incorporation by reference is particularly acute during rulemaking. Because public inspection requirements are not triggered until a rule is final, interested parties may have to buy a copy of a standard that an agency is considering incorporating by reference to meaningfully comment on the proposed rule.
The problem is particularly challenging because the obvious solutions are not workable. One solution would be to avoid incorporation by reference and simply print the extrinsic material in full in the text of the Notice of Proposed Rulemaking (NPRM) or final regulation. Another option would be to post the incorporated material in a location that is easy to find on the agency's website. If the material is copyrighted, however, these options are unavailable without the consent of the copyright owner. Buying out the copyright is often prohibitively expensive for a federal agency, particularly in these times of budget austerity. More aggressive solutions, such as abrogating copyright or requiring a waiver of copyright as a condition on incorporation, are likely to undermine the highly valuable public-private partnership in standards.
This Article proposes a collaborative solution to incorporation by reference's public access problem. Some agencies have successfully worked with standard developers to improve access to standards both during rulemaking and following promulgation. Technological tools such as read-only capability can provide ways to make the text of a standard broadly available to the public while retaining the value of the copyright to the standard developer. To date, just a few agencies have tried this approach, largely because the public access problem has only recently come to light. The success of these efforts, however, suggests that a collaborative approach provides the best chance for improving public access while retaining the benefits of the well-established federal standards policy.
A second challenge agencies face when incorporating by reference is keeping regulations current as incorporated standards are revised to reflect evolving technical knowledge. This issue arises because dynamic incorporations are prohibited. That is, agencies are required to identify the specific version of any material incorporated by reference. Incorporated materials, however, are typically highly technical and are regularly revised to reflect ever-evolving technical knowledge. Updating a regulation to reflect such changes typically requires an agency to conduct a notice-and-comment rulemaking. Particularly in light of other pressing regulatory priorities, agencies are not always able to expend the considerable resources required to update an incorporating regulation. Thus, for example, current regulations of the Occupational Safety and Health Administration (OSHA) continue to reference crane standards from the 1960s. (15)
Outdated references can endanger the public interest and cause a host of regulatory problems. Products available on the market are likely to conform to the most recent standards, so if a regulation uses an older standard, regulated parties may simply not be able to get equipment that is technically in compliance. This might actually be a good thing because technically noncompliant products that meet newer standards are likely to be safer. We would surely prefer construction companies use modern crane technology, rather than sticking with 1960s technology just to comply with outdated OSHA regulations.
Over the years, agencies have crafted a variety of approaches that can either mitigate the harms of outdated references or make updating easier. Using enforcement discretion or equivalency determinations can help ensure agency enforcement efforts genuinely serve the public interest. Other techniques, such as direct final rulemaking, can make it easier to update incorporating regulations. In some situations, however, available solutions are inadequate. This Article suggests a statutory solution to fill this gap.
Finally, incorporating by reference requires promulgating agencies to successfully navigate OFR's approval process and avoid common pitfalls in drafting regulations. OFR regulations govern this process and have evolved over the last decade in ways that improve the practice of incorporating by reference, but have caused some confusion. Some agencies experience fewer procedural and drafting difficulties than others. These agencies provide a model of best practices that other agencies should follow.
A number of issues related to incorporation by reference are outside the scope of this Article. First, this Article does not address distinct issues raised by incorporations by reference in agency procurements or acquisitions. Second, issues that arise within the standard-development process are outside the scope of this Article. Agencies that incorporate voluntary industry or consensus standards by reference into regulations may participate in the standard-development process. To the extent that this participation may improve the practice of incorporation by reference, this Article addresses the subject. Broader questions about how agencies should participate in voluntary standard-development processes are unrelated to the practice of incorporation by reference and are thus beyond the scope of this Article. So too are intellectual property (16) and antitrust (17) issues that may arise within the voluntary standard-development process.
This Article proceeds in five parts. Part I provides essential background information, including the legal and procedural rules governing incorporation by reference, the variety of regulatory purposes served by the practice, and the special role of voluntary consensus standards in federal regulation. Part II explores how agencies can expand public access to incorporated materials. There are a variety of approaches agencies have successfully used to achieve this goal within the constraints of federal law and regulatory policy. Part III discusses the challenges agencies face in updating regulations that incorporate regularly revised materials. Some agencies have greater difficulty updating than others, and different agencies have taken different approaches to ensure timely updates. Part IV addresses procedural and drafting issues agencies face when they seek to incorporate by reference. Here, as elsewhere, my research revealed winning strategies that agencies can and should adopt.
A. Context: The Public-Private Partnership in Standards
The significant value of the public-private partnership in standards merits careful consideration when evaluating the public policy questions raised by the practice of incorporation by reference. Federal policy recognizes, and agencies consistently report, that incorporating by reference conveys significant benefits, particularly as it relates to the use of voluntary consensus standards in regulations. Indeed, those agency personnel who were interviewed unanimously reported that, without the work of private standard-development organizations (SDOs), agencies would not have the time, resources, or technical expertise to fulfill their regulatory missions.
Using voluntary consensus standards in federal regulation yields a variety of public benefits. It is more cost-effective for agencies than creating government-unique standards through the rulemaking process. Office of Management and Budget (OMB) Circular A-119 recognizes this reality, identifying one of its goals as "[e]liminat[ing] the cost to the Government of developing its own standards and decreas[ing] ... the burden of complying with agency regulation." (18) Agencies consistently agree. For example, the Federal Energy Regulatory Commission (FERC) has explained that "[f]rom our experience, the [North American Energy Standards Board] process is [a] far more efficient and cost effective method of developing technical standards for the industries involved than the use of a notice and comment rulemaking process involving numerous technical conferences in Washington that all believe they have to attend." (19) The practice also allows agencies to capitalize on considerable expertise and resources available outside government. In addition, it decreases the burden of regulation and the costs of enforcement by conforming regulatory requirements to industry best practices. Indeed, regulated parties are often already complying with the voluntary standards that incorporation by reference makes mandatory. This reduces the discrepancy between industry practice and federal regulation, thereby avoiding confusion and reducing the costs of regulation.
The public-private partnership in standards also benefits the public by improving the process for developing voluntary consensus standards. It "[p]rovide[s] incentives and opportunities to establish standards that serve national needs." (20) It has also driven standard-development organizations to adopt more democratic, consensus-based procedures. As Professor Robert W. Hamilton reported in 1978, the original expansion of federal regulatory authority in health and safety was driven in part by concerns that voluntary standards were created in secret and did not adequately consider or serve the public interest. (21) Stan- developers responded to the threat of mandatory regulation by opening their processes and including a greater range of interests and perspectives in standard development. (22) Over the past thirty years, the federal policy favoring agency use of voluntary consensus standards has driven voluntary consensus organizations to continue to expand upon these efforts. (23) Of course, agencies play an important role in reviewing the results of the private sector process and determining whether incorporation into regulation, either as is or with modifications, would be in the public interest and would carry out applicable statutory obligations. Nonetheless, the beneficial effects of improvements to the standard-development process go far beyond regulation because industry voluntarily conforms to many, if not most, of the standards created through these modern, more open processes.
The public-private partnership in standards--which incorporation by reference facilitates--has reaped extraordinary benefits for both government and the private sector. In addressing the important public policy questions presented below, these benefits must be kept in mind. Any solution must preserve and improve--and not undermine--the valuable public-private partnership in standards.
B. Process: The Role of the Office of the Federal Register
To incorporate by reference, an agency must secure the approval of OFR (24) through a process, and according to standards, established by OFR regulations. (25) Under these regulations, material is available for incorporation by reference only if it fits within the Federal Register's incorporation by reference policy, (26) which requires that regulations conform to and not detract from applicable publication and Administrative Procedure Act (APA) requirements, (27) assumes that incorporations by reference are "intended to benefit both the Federal Government and the members of the class affected," (28) and demands that the reference be limited to a particular edition of the incorporated material. (29) Incorporated material must consist of "published data, criteria, standards, specifications, techniques, illustrations, or similar material," (30) and referring to it must "[s]ubstantially reduce the volume of material published in the Federal Register." (31) The material must also be "reasonably available to and usable by the class of persons affected," (32) with usability evaluated based on "[t]he completeness and ease of handling the publication," (33) and "[w]hether it is bound, numbered, and organized." (34)
OFR regulations are designed to ensure that incorporation by reference serves the public interest in an orderly codification of legally effective agency pronouncements. By requiring that incorporated materials are reasonably available to and usable by those affected, OFR regulations serve the goals of publication. At the same time, OFR regulations vindicate the efficiency goals of incorporation by reference. For example, OFR regulations reduce redundancy in federal publications by prohibiting the incorporation by reference of material already published in the Federal Register or United States Code. (35) Agencies are further prohibited from incorporating by reference material they publish themselves. (36) This rule prevents agencies from pulling regulations out of the CFR, publishing them elsewhere (for example, in a pamphlet or on the agency's website), and then incorporating them by reference. This vindicates the fundamental precept that agency pronouncements with general legal effect should be uniformly codified in the CFR.
OFR enforces its incorporation by reference policies via an established approval procedure. The procedure requires that agencies submit a written request for incorporation by reference along with a draft final rule. (37) OFR has twenty working days to process each request, and an agency's rule will not be published until approval is secured. (38) As discussed in greater detail below, this can cause problems, particularly if agency personnel are not sufficiently familiar with OFR requirements. (39) Incredibly, the OFR Director's staff of only three people carry out the responsibility of approving every incorporation by reference that appears in the CFR. (40) As we shall see, this practical constraint is an important consideration in evaluating ways to address the issues associated with incorporation by reference.
Once material is incorporated by reference, both OFR and the promulgating agency are required to keep a hard copy available in a reading room for public inspection. (41) This is the traditional method for providing public access to agency documents, including incorporated materials. It allows the public to view materials in person at OFR or at the promulgating agency's office. Inspection is available during regular business hours in OFR's reading room at its Washington, D.C. office. (42) OFR regulations provide that photocopies may be made at the inspection desk, (43) but OFR no longer provides a photocopier. (44) Individual agencies typically provide similar accommodations for public inspection.
OFR's current incorporation by reference regulations predate the electronic age. They have not been amended since they were originally issued in 1982. (45) Since then, Congress has pushed agencies to use new technologies to expand access to agency documents beyond what was possible when materials could only be made available in print. The Electronic Freedom of Information Act Amendments of 1996, (46) the Government Paperwork Elimination Act of 1993, (47) and the E-Government Act of 2002 (48) all require agencies to use digital technology to make information more available to regulated parties and the public. Although these statutes did not render OFR's incorporation by reference regulations unlawful, the regulations neither acknowledge nor affirmatively support the transition to the e-government age.
It bears emphasizing that "incorporation by reference," as defined by OFR regulations, occurs only upon a rule's promulgation. This is because OFR interprets 5 U.S.C. [section] 552(a), the statute that permits incorporation by reference with OFR approval, as applying only to materials that have general legal effect and are thus eligible for codification in the CFR. (49) This is important for two reasons. First, OFR does not get involved in evaluating an incorporating regulation until it is final and ready to be promulgated. During the rulemaking process, the promulgating agency must therefore take on the burden of evaluating whether a material is appropriate for incorporation, including whether it is "reasonably available." Second, the public inspection requirement is not triggered until a rule's promulgation. Agencies must therefore take responsibility for ensuring that materials are available for interested parties to review during the rulemaking process.
C. Regulatory Uses of Incorporation by Reference
Incorporation by reference serves a variety of substantive regulatory policies. Agencies incorporate government materials, such as state regulations or Government Printing Office (GPO) publications. Agencies also incorporate nongovernmental materials, ranging from design specifications to product manuals to books to privately-created standards. In each case, incorporation serves an agency's specific regulatory needs. With respect to standards, incorporation by reference also vindicates a longstanding federal policy favoring federal agency use of voluntary consensus standards. (50)
To properly evaluate incorporation by reference's current policy challenges, we must understand its broader role in regulatory policy. While the issues raised by the practice--public access hurdles, updating challenges, and procedural and drafting difficulties--are common to all agencies, the techniques used to address those issues vary. The success of each technique depends on the nature of the incorporated material and the precise regulatory purpose served by incorporation. In short, identifying best practices requires an understanding of what--and why--agencies incorporate by reference.
1. Types of Incorporated Materials
Government documents, including state regulations and GPO publications, constitute one kind of material often incorporated by reference into the CFR. Indeed, the incorporation by reference by the Environmental Protection Agency (EPA) of state environmental regulations accounts for a significant number of the incorporation by reference requests processed by OFR. (51) The Clean Air Act, for instance, requires state and local pollution control agencies to adopt federally approved air pollution control regulations. (52) EPA approves these regulations, referred to as "State Implementation Plans," by incorporating them by reference into the CFR. (53) Agencies may incorporate other government documents, including federal agency publications, to serve various regulatory purposes. (54) For example, OSHA has incorporated by reference the Federal Highway Administration's Manual on Uniform Traffic Control Devices into its regulations governing accident prevention for construction workers. (55)
Nongovernmental materials are also commonly incorporated by reference. The incorporation by the Federal Aviation Administration (FAA) of manufacturer service manuals into its airworthiness directives accounts for a substantial percentage of the incorporation by reference requests processed by OFR. (56) Airworthiness directives, which FAA issues on a nearly daily basis, are "legally enforceable rules" regarding the proper maintenance of "aircraft, aircraft engines, propellers, and appliances." (57) FAA regulations broadly require anyone who operates such a "product" to maintain it in a safe and airworthy condition. This general obligation finds specific expression in airworthiness directives, (58) which FAA issues when it finds "[a]n unsafe condition" (59) that "is likely to exist or develop in other products of the same type design." (60) The directives specify inspections, maintenance actions, or repairs necessary to guard against the identified unsafe condition. In most cases, this information is already available in the repair manual published by the product's manufacturer. FAA incorporates by reference the relevant provisions of the manual to make the repair or inspection mandatory, while avoiding errors that might result if the agency attempted to paraphrase the manufacturer's instructions. Other agencies incorporate nongovernmental materials for radically different regulatory purposes. For example, the Nuclear Regulatory Commission (NRC) incorporates design specifications by reference as a means of approving "a final standard design for a nuclear power facility." (61)
Standards, which may be governmental or nongovernmental, are a third kind of material frequently incorporated by reference into the CFR. Although there are many types of standards, one is particularly important: voluntary consensus standards. For nearly four decades, federal policy has strongly favored the use of such standards in regulations in lieu of government-unique standards. (62) Created by private standard-development corporations and frequently copyrighted, these standards pose particular challenges in the incorporation by reference context.
2. The Role of Federal Standards Policy
The policy preference for voluntary consensus standards is embodied in the National Technology Transfer and Advancement Act of 1995 (NTTAA) and Office of Management and Budget (OMB) Circular A-119. (63) The NTTAA requires federal agencies to use technical standards created by voluntary consensus standard setting organizations (64) unless doing so "is inconsistent with applicable law or otherwise impractical." (65) OMB Circular A-119 (66) expands upon the NTTAA's policy. First proposed in 1976 (67) and partially codified by the NTTAA, Circular A-119 "directs agencies to use voluntary consensus standards in lieu of government-unique standards except where inconsistent with law or otherwise impractical." (68) Crucial to the definition of a "voluntary consensus standard" is the use of procedures designed to yield "[c]onsensus, which is defined as general agreement, but not necessarily unanimity." (69) The procedures must "include a process for attempting to resolve objections by interested parties" before the final vote on the standard. (70) Moreover, the Circular clearly articulates the goals of the policy it establishes (71) and enumerates factors agencies should consider when evaluating a voluntary consensus standard. (72) Any agency that uses a government-unique standard instead of an existing voluntary consensus standard must report and explain its decision to OMB. (73) In some cases, the agency has no such discretion because Congress has required the use of a particular voluntary consensus standard. (74)
This policy has roots in a recommendation of the Administrative Conference of the United States. In the late 1970s, the Conference conducted a study that culminated in Conference Recommendation 78-4, Federal Agency Interaction with Private Standard-Setting Organizations in Health and Safety Regulation. (75) This recommendation provided guidance to agencies and Congress on maximizing the benefits of agency participation in voluntary standard-development activities. (76) It urged agencies to "consider the use of existing relevant voluntary consensus standards in developing mandatory standards," but to do so using "due caution ... on a case-by-case basis." (77) The recommendation enumerated factors agencies should consider when evaluating voluntary standards for inclusion in regulations, (78) provided guidance about how agencies could adapt voluntary standards to suit regulatory needs, (79) and urged agencies to "take special care to avoid needless inconsistencies between voluntary and mandatory standards" and "remain abreast of technological change." (80)
The use of voluntary consensus standards in regulations yields significant benefits to both the government and the public at large. It is an efficient, cost-saving approach that makes regulations easier to develop and enforce. It also captures many of the benefits of collaborative governance by engaging the private sector in a more cooperative regulatory effort and giving agencies access to the significant experience and technical expertise outside government. These policy advantages are explored in greater detail below.
3. The Current State of Standards in Regulation
Today, standards, including voluntary consensus standards, account for thousands of incorporations by reference in the CFR. As of January 6, 2012, the National Institute of Standards and Technology (NIST) Standards Incorporated by Reference Database included 9475 records of standards incorporated by reference into the CFR. (81) The top ten organizations with standards incorporated by reference are as follows:
Standard-Development Number of Incorporations by Organization Reference in CFR (82) American Society for Testing and 2230 (885) Materials (ASTM) American National Standards 554 (179) (83) Institute (ANSI) American Society of Mechanical 536 (60) Engineers (ASME) U.S. Environmental Protection 464 (287) Agency (EPA) Society of Automotive Engineers 435 (156) (SAE) National Fire Protection 370 (88) Association (NFPA) American Petroleum Institute (API) 280 (63) International Maritime 226 (78) Organization (IMO) AOAC International (AOAC) 211 (211) National Academy Press (NAP) 198 (187)
As this list shows, a variety of standards are incorporated by reference into the CFR, "includ[ing] ... voluntary consensus standards, government unique standards, private industry standards, and international standards." (84)
Agencies incorporate standards into the CFR to serve a diverse array of regulatory purposes. For example, the Coast Guard's marine engineering regulations "adopt a great number of industry standards for power boilers, piping systems, and main and auxiliary machinery" for various types of vessels, "includ[ing] tank vessels, cargo and miscellaneous vessels, mobile offshore drilling units, off shore supply vessels, and small passenger vessels," (85) while its equipment approval regulations incorporate voluntary consensus standards for, among other things, life preservers, (86) flares and distress signals, (87) inflatable liferafts, (88) and thermal protective aids. (89) The Federal Energy Regulatory Commission (FERC) uses incorporation by reference to make industry standards, usually created by the North American Energy Standards Board (NAESB), mandatory for wholesale and retail energy providers. (90) The Nuclear Regulatory Commission (NRC) incorporates voluntary consensus standards into its regulations governing construction permits and licenses for nuclear reactors. (91) Other agencies, including the Consumer Product Safety Commission (CPSC) (92) and the Occupational Health and Safety Administration (OSHA), (93) use voluntary consensus standards in health and safety regulation, as contemplated by Recommendation 78-4. (94) These examples, though far from exhaustive, suggest the diverse purposes for which agencies incorporate standards by reference in regulations.
4. Emerging Issues with Incorporation by Reference
Incorporation by reference has been consistently--and uncritically-viewed as the appropriate way for agencies to "use" voluntary consensus standards in regulations. Recommendation 784, taking the view of the Conference's consultant, Professor Robert W. Hamilton of the University of Texas School of Law, (95) identified incorporation by reference as the preferable means for including a voluntary standard in a mandatory health and safety regulation. (96) And Circular A-119 defines agency "use" of a voluntary consensus standard as "inclusion of a standard in whole, in part, or by reference in regulation(s)." (97)
The time has come to think critically about the policy implications of incorporation by reference. Over the nearly four decades since federal policy began to embrace the use of voluntary consensus standards in regulation, incorporation by reference has expanded considerably. Agencies have had time to identify and begin to address the issues the practice raises. The rise of e-government has transformed the relationship between agencies and the public, throwing the public access implications of incorporation by reference into sharp relief. The passage of time has similarly revealed the significant challenges agencies face in keeping regulations up to date as standards are revised to reflect ever-evolving technical knowledge. In similar fashion, time and experience have revealed difficulties with OFR's approval process and potential pitfalls in drafting incorporating regulations. The rest of this Article confronts these considerable challenges.
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|Title Annotation:||Introduction through I. Background, p. 131-153|
|Author:||Bremer, Emily S.|
|Publication:||Harvard Journal of Law & Public Policy|
|Date:||Jan 1, 2013|
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