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Session No. 516

Legal Implications of Voluntary Consensus Standards Adele L. Abrams, Esq., CMSP Law Office of Adele L. Abrams, P.C. Beltsville, Maryland The federal government has a long history of using voluntary consensus standards (VCS) to establish enforceable standards and regulations, as well as including references to such standards into nonbinding policy and guidance documents. There are literally hundreds of VCS currently incorporated by reference into government standards used daily by safety, health and environmental professionals: consensus standards developed by organizations including the American National Standards Institute (ANSI), the National Fire Protection Association (NFPA), ASTM International, and many others. These standards are developed through precise processes, which must be transparent and have comment and appeal mechanisms, and the technical committees that write the standards are to be balanced in interest. The use of consensus standards by government, thorough "Incorporation by Reference" (IBR), got a significant boost in February 1996, when Section 12(d) of Pub. L. 104-113, the "National Technology Transfer and Advancement Act of 1995," ("TTA" or "the Act" - 15 USC §272) was ed by the Congress. The purpose of the legislation was to establish the policies of the existing OMB Circular A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, into law. The intent of Section 12(d) of the Act was: (1) to direct "federal agencies to focus upon increasing their use of [voluntary consensus] standards whenever possible," thus, reducing federal procurement and operating costs; and (2) to authorize the National Institute of Standards and Technology (NIST) as the "federal coordinator for government entities responsible for the development of technical standards and conformity assessment activities," thus eliminating "unnecessary duplication of conformity assessment activities" (Cong. Rec. H1262 (February 27, 1996) (statements of Rep. Morella)). The OMB circular (consistent with Section 12(d) of TTA) directs agencies to use voluntary consensus standards in lieu of developing government-unique standards, except when such use would be inconsistent with the law or otherwise impractical. Incorporation by reference (IBR) of voluntary consensus standards (VCS) allows agencies to fulfill their legal obligation to publish rules in the Code of Federal Regulations (CFR) by referring to standards or other materials that have been published elsewhere. For example, when an agency adopts a standard created by a private standard-setting organization as a mandatory regulation, it typically publishes the standard by incorporating it by reference into the CFR. Such incorporation by reference is common in part because federal policy, some agencies' specific statutory language, or the TTA may require regulatory agencies to use voluntary consensus standards in lieu of government unique standards where this is not impracticable or inconsistent with statutory mission.

Under the Occupational Safety & Health Act of 1970, only consensus standards that have been adopted as or incorporated by reference into an Occupational Safety & Health istration (OSHA) standard pursuant to Section 6 of the OSH Act provide a means of compliance with Section 5(a)(2) of the OSH Act. In fact, most currently enforceable OSHA standards have their genesis in the consensus standard environment. Specific national consensus standards [e.g., American National Standards (ANSI) standards], which the Secretary of Labor adopted on May 29, 1971, were either used as a source standard and published in Part 1910 as an OSHA standard or explicitly incorporated by reference in an OSHA standard because, as a new agency, OSHA otherwise had no safety or health regulations to enforce! Even today, OSHA also often looks to consensus standards as a benchmark for "notice" to employers for General Duty Clause enforcement under Section 5(a)(1) of the OSH Act or to determine abatement requirements for violations. When OSHA determines that recognized experts’ find, in a voluntary consensus standard, that a series of actions or conditions are required to prevent harm to workers, this is likely to satisfy the requirement for GDC applicability under the applicable legal tests. Voluntary guidelines, including standards promulgated by ANSI, have been used to GDC citations and to enunciate an industry “standard of care” even though the consensus standards themselves are not specifically enforceable by the agency. An increasingly troublesome issue has arisen with respect to whether a government agency's action to IBR a VCS has implications for the validity of the copyright held by the standards development organization for the incorporated standard. This is now being litigated by several SDOs, as discussed below, and is under congressional scrutiny. As noted by the istrative Conference of the United States: Ensuring that regulated and other interested parties have reasonable access to incorporated materials is perhaps the greatest challenge agencies face when incorporating by reference. When the relevant material is copyrighted — as is often the case with voluntary consensus standards — access issues are particularly problematic. There is some ambiguity in current law regarding the continuing scope of copyright protection for materials incorporated into regulations, as well as the question of what uses of such materials might constitute “fair use” under section 107 of the Copyright Act. Efforts to increase transparency of incorporated materials may conflict with copyright law and with federal policies recognizing the significant value of the public-private partnership in standards. istrative Conference Recommendation 2011-5, December 8, 2011. In addition, the Office of the Federal (OFR) is statutorily charged with approving all incorporations by reference, and has issued regulations and guidance establishing policies and procedures for doing so. The OFR is now engaged in a rulemaking on the issue of IBR and what constitutes "reasonably available" for purposes of the Federal Act. This paper explores the legal and regulatory morass involving incorporation by reference or enforcement of voluntary consensus standards at the federal government level, and the associated litigation and recommendations on the subject.

VCS and OSHA Rulemaking OSHA currently has several rulemaking items on its regulatory agenda that have implications for potential incorporation by reference of voluntary consensus standards, either as stand-alone rules or to supplement other requirements that OSHA chooses to include in a final standard. The main rulemaking agenda items are the safety and health management program initiative - known as "I2P2" - which may incorporate all or part of the ANSI Z10 standard on this subject; the combustible dust rulemaking, which may end up including all of part of the new NFPA standard 652 (or, perhaps, other NFPA combustible dust standards that deal with specific types of dust); and the respirable crystalline silica health standard, which is currently at the proposed rule stage. Using the crystalline silica standard as an example, the proposed rule that was published on September 12, 2013 (78 FR 56274), includes internal references to two ASTM standards, and seeks comment on whether the agency should follow these standards in whole or in part, as OSHA is required to do under the TTA. ASTM has released two different VCS relating to crystalline silica, which are both internally referenced in the proposed OSHA rule: ASTM E1132-06, Standard Practice for Health Requirements Relating to Occupational Exposure to Respirable Crystalline Silica and ASTM E2625-09, Standard Practice for Controlling Occupational Exposure to Respirable Crystalline Silica for Construction and Demolition Activities. Although a 2013 revision of ASTM E1132 is in progress, OSHA chose to reference the most recent completed version, the 2006 version. This points to an ongoing issue with incorporation by reference; namely, that by the time a federal agency completes a drawn-out rulemaking initiative, often the private sector's VCS standards have been updated or even withdrawn. However, in light of the TTA, as implemented by OMB Circular A-119, these ASTM standards must be considered – and perhaps incorporated by reference -- by OSHA in its crystalline silica health standard. The Mine Safety & Health istration (MSHA) also has crystalline silica on its rulemaking agenda, and has indicated it will follow OSHA's lead, which means that these ASTM standards could also ultimately have binding effect in mining workplaces, even though they were not designed for this purpose. ASTM’s silica standards do not set exposure limits, nor specify any particular sampling and analytical method. They do, however, recognize both the current OSHA and MSHA PELs, as well as the NIOSH REL for respirable silica, and the occupational exposure limit values from 18 other nations. In addition, the standards recognize NIOSH Method 7500 (XRD), NIOSH Method 7601 (Visible Absorption Spectrophotometry), NIOSH Method 7602 (crystalline silica), and NIOSH Method 7603 (coal mine dust) (in E1132-06 only), as well as the 2000 Guidelines for Use of ILO International Classification of Radiographs of Pneumoconioses. The ASTM standards encourage employers to sample and maintain records of occupational exposures of workers exposed to respirable crystalline silica, to use supplied air respirators or ventilated enclosures where workers are engaged in dusty trades having common overexposures to respirable silica, and to establish Exposure Control Plans in areas with persistent overexposures. ASTM E1132 also establishes a hierarchy of engineering controls, istrative controls, respiratory protection, and work practices to be used where there is concern for exposures exceeding one-half of the PEL (similar to the “action levels” specified in some OSHA and MSHA health

standards). This ASTM standard also sets forth provisions for hygiene facilities, medical surveillance, exposure monitoring, medical protection, worker training and education, and warning signs and labels. ASTM E2625 was developed to address occupational silica exposures during construction and demolition activities. It is intended to protect workers against clinically significant disease from exposure to respirable crystalline silica, to have silica exposure measured by techniques that are valid, reproducible and readily available, and to be attainable with existing technology and protective practices. It sets forth general requirements for exposure assessment and monitoring, methods of compliance, work practices, and istrative controls. The standard also addresses respiratory protection, advising that respirators should be mandated in work situations where engineering and work practice controls are insufficient to reduce exposures below the applicable occupational exposure limit. The standard emphasizes medical surveillance, medical protection for workers in of x-ray screening criteria, worker training and education, competency of workers in of task training, and recordkeeping. ASTM E2625 also offers guidance for different operations and tasks associated with construction and demolition in identifying what control measures and respiratory protection may be approach in different situations, and information from these ASTM tables has been adopted by OSHA in the proposed rule into "Table 1" which establishes protocols for certain construction tasks to limit silica exposures. In short, these ASTM standards could easily form the basis for a comprehensive crystalline silica health standard. If, however, OSHA simply incorporates these by reference, rather than explaining in the Code of Federal Regulations the specific requirements, this will add fuel to the fire on the issue of whether ASTM would have to make the standards available to the public free of charge, in order to meet the "reasonably available" criteria in the Federal Act, as discussed in more detail below.

VCS and the General Duty Clause While OSHA already has many specific standards that incorporate by reference myriad voluntary consensus standards (VCS), OSHA can also enforce best practices for control of recognized hazards through its “General Duty Clause,” Section 5(a)(1) of the Occupational Safety and Health Act of 1970. This requires that, where no specific standard is codified, but there is a recognized risk that employers must control, enforcement action can be taken. OSHA’s “General Duty Clause” requires each employer to “furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.” 29 U.S.C. § 654 (a)(1). Often, voluntary consensus standards (VCS) serve to set a benchmark for what employers knew or should have known, as well as to assist in determining what are feasible control methodologies. OSHA's Field Operations Manual (FOM, L 02-00-150 (April 22, 2011)), elaborates on how the agency can use VCS to impute knowledge of hazards to certain employers for purposes of General Duty Clause enforcement. The FOM states: If the relevant industry participated in the committees drafting national consensus standards such as the American National Standards Institute (ANSI), the National Fire Protection Association (NFPA), and other private standard-setting organizations, this can constitute industry recognition. Otherwise, such private standards normally shall be used only as corroborating

evidence of recognition. Preambles to these standards that discuss the hazards involved may show hazard recognition as much as, or more than, the actual standards. However, these private standards cannot be enforced as OSHA standards, but they may be used to provide evidence of industry recognition, seriousness of the hazard or feasibility of abatement methods. OSHA adds that VCS can also be referenced to determine whether abatement requirements are reasonable when terminating a cited condition. While such consensus standards shall not solely be relied upon to mandate specific abatement methods, often they are incorporated into manufacturer handbooks that address safety measures for hazardous equipment or standards to be followed for safe electrical installations. As an example, OSHA uses the ANSI standard that addresses the hazard of exposure to hydrogen sulfide gas and refers to abatement methods such as preventing buildup of materials that create gas and provision of adequate ventilation. In OSHA's view, this ANSI standard could be used as general evidence of the existence of feasible abatement measures. (FOM, 4-23)

Incorporation by Reference Rulemaking Under Federal Act Incorporation by Reference (IBR) is a potentially valuable tool for federal agencies to reduce the time and effort needed to engage in rulemaking, and as discussed above, may be required under the Technology Transfer Act of 1995 and OMB Circular A-119, which requires any federal agency embarking on standardsetting to use any "on point" consensus standard instead of recreating the wheel, unless the agency determines that such action is not appropriate. The key IBR issue centers on the fact that standards development organizations (SDOs) charge a fee for access to their standards (and also copyright such materials), even after these standards are being incorporated into federal regulation. The Office of Federal (OFR) regulations require that materials incorporated by reference be “reasonably available” to the public, although that term is not defined. 1 C.F.R. §51.7(a)(4). The OFR must, however, keep a hard copy of any materials incorporated by reference at the federal level, and make it available for public inspection. At state and local levels, standards that are incorporated by reference must also be made available for inspection in government offices or designated depository libraries. Opponents of consensus standards challenge inaccessible standards that are incorporated as "secret rules" that agencies enforce without giving access to what is required for compliance. Theoretically, OSHA and MSHA local or regional offices are supposed to have incorporated standards available for review (but not copying) but in practice this does not seem to be the case, and even where standards are available at these locations, it may be difficult for an employer to travel to the government office and the agencies will not fax or email the standards because of the copyright issues. Therefore, a true practical issue is raised when the regulated community has no actual notice via a government publication or website as to what behavior is prohibited or compulsory. On October 2, 2013, the Office of the Federal (OFR) partially granted a petition for rulemaking, and proposes to amend its "incorporation by reference" regulations. The petition had been filed in 2012 by Professor Peter L. Strauss, a senior fellow of the istrative Conference of the United States (ACUS). If finalized, OFR could require agencies to secure “informal” OFR approval to publish a proposed rule that, if adopted, would incorporate extrinsic material by reference. At this stage, an agency would be required to include in the preamble either a discussion of what it

has done to ensure the reasonable availability “to interested parties” of the to-be-incorporated material or a summary of that material. At the final rule stage, the discussion of "reasonable availability" would always be required in the preamble. The proposed rule also states that OFR plans to revise its Document Drafting Handbook to encourage agencies to implement relevant provisions of ACUS' Recommendation 2011-5 concerning IBR. Comments on the proposed rules were due December 31, 2013. More than 35 comments were submitted, and OFR is now in the process of evaluating the input before developing a final rule. Whether it will determine that any consensus standards which are IBR by an agency must be available, free of charge, on the internet is at issue, although OFR has already recognized the copyright interest of SDOs warrants serious consideration. The petitioner's requested regulation text would require agencies to demonstrate that material proposed to be IBR'd in the regulation text was available throughout the comment period: in the Federal Docket Management System (FDMS) in the docket for the proposal or interim rule; on the agency's Web site; or readable free of charge on the Web site of the voluntary standards organization that created it during the comment period of a proposed rule or interim rule. The petition suggested limiting IBR eligibility only to standards that are available online for free and to apply this to documents that would otherwise be considered guidance documents, as well as formal rules. And, it would limit the OFR's review of agency created materials to whether the material is available online. The petition would then distinguish between required standards and those that could be used to show compliance with a regulatory requirement. Finally, the petition (if granted in the final rule) would add a requirement that, in the electronic version of a regulation, any VCS material IBR'd into that regulation would be hyperlinked. In summary, OFR is now considering whether to require that: (1) All material IBR'd into the CFR be available for free online; and (2) the Director of the Federal (the Director) include a review of all documents agencies list in their guidance, in addition to their regulations, as part of the IBR approval process. OFR has already responded, in its proposal, that some of these requests go beyond the agency's statutory authority. Nothing in the istrative Procedure Act (APA) (5 U.S.C. chapter 5), E-FOIA, or other statutes specifically address this issue. Moreover, OFR seems reluctant to require that all materials IBR'd into the CFR be available for free, recognizing that this requirement would compromise the ability of regulators to rely on voluntary consensus standards, possibly requiring them to create their own standards, which is contrary to the TTA and the OMB Circular A-119. Meanwhile, on October 28, 2013, the American National Standards Institute (ANSI) launched the ANSI IBR Portal, http://ibr.ansi.org/, an online tool for free, read-only access to voluntary consensus standards that have been IBR’ed into federal laws and regulations. IBR standards hosted on the portal are available exclusively as read-only files. In order to protect the intellectual property rights of the groups holding these standards’ copyrights, the portal has built in security features that prevent s from printing, ing, or transferring any of the posted standards; in addition, screenshots will be disabled and the standards will contain an identifying watermark. ASSE is the secretariat for many ANSI standards, including the popular A10 series of best practices for construction and demolition projects. According to ANSI, for this first phase of the portal, ANSI has secured the participation of thirteen major domestic and international standards developers. Those that have agreed to have their IBR standards directly available on the ANSI IBR Portal include:

• • • • • •

the International Organization for Standardization (ISO); the International Electrotechnical Commission (IEC); the Association of Home Appliance Manufacturers (AHAM); the American Welding Society (AWS); the International Association of Plumbing and Mechanical Officials (IAPMO); and the Illuminating Engineering Society (IES)

In addition, seven SDOs have agreed to allow the portal to provide direct links to read-only versions of IBR standards hosted on their own websites. Those organizations are: • • • • • • •

the American Petroleum Institute (API); the American Plywood Association (APA); the American Society of Heating, Refrigerating, and Air Conditioning Engineers, Inc. (ASHRAE); the Manufacturers Standardization Society (MSS); NACE International - the Corrosion Society; the National Fire Protection Association (NFPA); and UL (Underwriters Laboratories).

With the launch of Phase I of the portal, ANSI expects that many more SDOs – both in and outside the community of ANSI-accredited standards developers – will sign on to participate. Other groups, such as ASTM International, have adopted "read only" access that permits mandatory s to view the information without waiving copyright claims by the SDO. See http://www.astm.org/READINGLIBRARY/index.html. Of course, it bears mentioning that SDOs incur significant costs for initiating the standards development process, convening and hosting meetings of technical committees (in person and via the web), overseeing the editing, formatting and publication of standards, hosting websites, maintaining inventory etc. ASSE participates in the development and maintenance of key privately developed safety standards in two ways: by serving as secretariat for several standards committees and by serving on many other safety standards committees. All ASSE standards development activities are conducted within the framework established by ANSI for the development of consensus standards. Without the ability to recoup these expenses, it is foreseeable that standards development could wither away, or organizations would be reluctant to serve voluntarily as the secretariat. Moreover, despite the opposition raised to "paying for the law," most consensus standards are affordable to businesses, unions, consultants and professionals who use them. The average ASTM standard costs $30, NFPA sells the 800-page National Electrical Code (NEC) for $75, and even highly technical building codes can cost as little as $100. The SDOs have also pretty universally provided for instantaneous electronic of standards, both current and older editions. This is certainly a service worth maintaining!

Litigation to Prohibit VCS Copyright Infringement In response to petitions to force the government to seize control of voluntary consensus standards that it incorporates by reference (IBR), by defining "reasonably available" in the Federal Act to mean "free to all," the standards development organizations have fired back ... this time in court, against Public Resource Organization Inc. (PR). The lawsuit for copyright infringement, trademark infringement,

unfair competition and false designation of origin, and common law claims, was filed on August 6. 2013, in the U.S. District Court for the District of Columbia. The plaintiffs are heavy-hitting SDOs: ASTM International, the National Fire Protection Association (NFPA), and the American Society of Heating, Refrigerating, and Air Conditioning Engineers, Inc. (ASHRAE). The plaintiffs seek a permanent injunction against any unauthorized publication or distribution (printed or electronically) of plaintiffs' standards or use of plaintiffs' trademarks, plus attorney fees and other relief appropriate. What did the defendant, Public Resource, do? Without permission, it purchased 73 of plaintiffs' standards, mailed them to various officials, the media and some of the public, and also scanned and posted on several internet websites the standards, most of which had been incorporated by reference into federal, state or local laws. Significantly, the defendant also allegedly altered some of the standards, including rekeying some text, altering graphics, and making mathematical changes. The plaintiff expressed concern that such documents, bearing plaintiffs' logos, would be mistaken for the unaltered originals and public safety could suffer due to lack of quality control and the unauthorized alterations (not approved by the SDOs technical committee). In some cases, outdated standards were the ones posted, which increases potential confusion that these represent the current "best practices." The outcome of the litigation has not been determined, but this is also not the first such case to be litigated. The landmark case in this area is Veeck v. Southern Building Code Congress International, In c., 293 F.3d 791 (5th Cir. 2002). In Veeck, the court held that in some instances model building codes developed by an organization adopted by government entities into regulations may become law, and to the extent that the building code becomes law it enters the public domain. Federal law still provides exclusive ownership rights for copyright holders, however, and provides that Federal agencies can be held liable for copyright infringement. Additionally, both the TTA and OMB Circular A-119 require: "If a voluntary standard is used and published in an agency document, your agency must observe and protect the rights of the copyright holder and any other similar obligations." Public Resource's theory in of its action is set forth in the court documents: The law belongs to the people, and cannot become the private property of some governmental or non-governmental organization, no matter how seemingly welldeserved are the rents one could extract from winning a monopoly concession on a parcel of the law. While standards bodies need money to carry out their valuable work, and while it is clear that these standards bodies create high-quality documents that are essential to our public safety, one cannot cordon off the public domain simply because of an institutional desire for funds. The plaintiff SDOs maintain that, if Public Resource succeeds in convincing the court that an SDO's copyright is destroyed whenever the government incorporates the standard by reference into regulations, SDOs will lose their exclusive rights to their work, and would be unable to charge fees to of industry or other interested persons who want copies of standards. The SDOs are all non-profit entities and a majority of their revenue to fund operations and standards development activities comes from sale or licensing of the standards. Plaintiffs argue that depriving them of this revenue source would substantially diminish the quality of future standards (or drastically cut back on standards development activity), especially impacting the health and safety areas which are most often IBR by government entities. There are unintended costs as well, if SDOs cease standards development, as the federal, state and local governments would then have to assume the costs of future standards development, and many agencies lack the funds, experience and technical expertise to create standards comparable to those of the SDOs, such as the regular updating of the National Electrical Code (NFPA 70) or the essential Life Safety

Code (NFPA 101). The government also lacks the flexibility to quickly respond to new technology by updating a standard, which is why too often the IBR standards are those from the 1980s or beyond! Any vitiation of copyright as a result of authorized or unauthorized IBR of a VCS could well have potential to destroy the cooperative and transparent system of consensus standard development that has grown and thrived for over 100 years. But, ultimately, inquiry as to whether a governmental action -forcing SDOs to make their standards work product available free of charge -- constitutes an unconstitutional taking, in violation of the Fifth Amendment (federal) and Fourteenth Amendment (state action), does not lend itself to any set formula. A determination of whether justice and fairness require that economic injuries caused by public action be compensated by the government, rather than remain disproportionately concentrated on a few persons, is essentially ad hoc and fact intensive. (10 A.L.R. Fed. 2d 231 (2006)).

ACUS and the VCS/IBR Issue President Barack Obama has said: "ACUS is a public-private partnership designed to make the government work better." According to istrative Conference of the United States (ACUS), which for 50 years has advised the federal government on istrative law issues including those surrounding rulemaking activities, the practice of incorporating by reference consensus standards has many benefits, including that it reduces the size of the CFR, enables agencies to draw on the expertise and resources of private sector standard developers to serve the public interest, and allows agencies to give effect to a strong federal policy (embodied in the TTA and OMB Circular A-119) in favor of agency use of voluntary consensus standards. ACUS' hip is composed of innovative federal officials and experts with diverse views and backgrounds from both the private sector and academia. In recent years, ACUS has focused on three issues agencies frequently confront when incorporating by reference: (1) ensuring materials incorporated by reference are reasonably available to regulated and other interested parties; (2) updating regulations that incorporate by reference; and (3) navigating procedural requirements and resolving drafting difficulties when incorporating by reference. Standard developers often do not want government funds for standard development because it degrades their independence and reputation of neutrality, although it is not uncommon for representatives from OSHA, MSHA and NIOSH to sit on standard-development committees of ANSI, ASTM and the like. Further, standard developers do not specifically develop standards with the intention of government agencies incorporating the standard by reference. If payment continues to be required for all consensus standards, agencies could have difficulty providing the standards at no cost to the public due to budget restrictions. Some possible options being explored include (1) purchasing a few copies that are available at the library of congress or local agency field offices and (2) purchasing licenses to enable read-only access during the notice and comment period. Another issue is that, when a standard developer updates their standard, the CFR does not reference the updated standard, unless the agency initiates new rulemaking. This has been part of the object of OSHA's ongoing Standards Improvement Project, but MSHA has not endeavored to update its myriad incorporated consensus standards in the same manner.

ACUS has sought additional public input on the VCS/IBR issue in a variety of forums, including workshops at the National Academy of Sciences and the George Washington University Regulatory Studies Center, and through stakeholder meetings of the US Small Business istration. Among the points made by participants at some of the ACUS meetings: •

•

A systematic review of research evidence is necessary that is transparent and available. better planning must be set forth before agencies begin the scientific research. This includes clearly identifying what problem is to be solved, assessing all data available, identifying and providing transparency on what data has been excluded from the study versus what data has been included. The public and interested scientists are not provided the raw data to review and analyze. However, challenges to this request have been made by parties who control the data. Often, models are patented and the company who performed the research will not provide it to industry for industry to perform an independent assessment of the data. Peer review is viewed as a missing element to the agency process that some feel is a disservice to the public, industry, and other scientists. Policy and research of papers developed for agencies should be reviewed. Independent scientists who are experts in the field of study discussed should perform reviews similar to academic reviews of papers submitted for professional publication.

In response to the ACUS project, OSHA Assistant Secretary David Michaels suggested including a set of new recommendations that increase the ability of the public and the agencies to scrutinize the science submitted by regulated parties. These recommendations build on existing requirements in law and in the biomedical journal. Dr. Michaels cited both his own pre-OSHA work and recommendations in the BiPartisan Policy Center Report as examples of potential recommendations that would provide for this enhanced transparency of the data and provenance of studies produced by regulated parties. The next iteration of the ACUS report will include a new set of recommendations that provide greater transparency for privately produced research that informs regulation. There was also a recommendation regarding the Identification of Important Gaps in Scientific Research, calling on agencies to identify significant knowledge gaps and discuss what might be done to fill them. Several ists suggested that in developing robust discussion of policies, agency staff should be allowed and even encouraged to publish their dissents in the peer reviewed literature. By doing so, the dissent would not only be public, but would undergo external checks on reliability and ensuring that there is evidentiary for the dissent. While there is no one-size-fits-all approach to peer review, there are additional procedures that could be added that will further improve the agencies’ use of external peer reviewers. Several suggestions to be considered in the next iteration of the report include: the use of stopping rules for peer review that limit the use of peer review when it is no longer necessary; soliciting letters or comments from individual peer reviewers in advance of their collective deliberations in science advisory boards; expecting agencies to provide a public response to significant peer review comments; and soliciting from peer review s whether and how they might view their charge as incomplete when compared with the agency’s regulatory decision. It was also notes that where lawyers, economists, or others are involved in drafting staff technical reports, they should be identified either by name or attributed as part of the agency’s interdisciplinary team. The discussion and recommendation concerning authorship and attribution in the report will be expanded to

underscore the need to disclose the identity of all staff who contributed to staff technical reports in significant ways, even if they are not scientists. For additional information on the ACUS project, see http://www.acus.gov/research/theconference-current-projects/science-in-the-istrative-process.

Conclusion Standards developed by the consensus SDOs discussed herein are created through procedures that are marked by their openness, balance of interests represented, fairness and transparency. Many thousands of safety, health, engineering, and environmental professionals put countless hours into developing a standard of practices that will protect persons, property and the environment. Undoubtedly, the collective wisdom of the professionals who undertake standards development allows for more rapid adoption of more protective technologies, work practices, analytical methods and design principles than could ever be accomplished by a governmental agency. It is not just prudent practice, but legally required, that the federal government consider whether there is a VCS "on point" when embarking on a rulemaking initiative ... and either incorporate by reference the VCS or explain why it is departing from the consensus practice. This saves government resources, taxpayer dollars, and allows for more timely adoption of appropriate control methodologies. This is an interesting time, however, for the future of voluntary consensus standards and the SDOs that create them. The outcome of the copyright infringement litigation, and the determinations made by the Office of Federal in defining at last what "reasonably available" means in today's regulatory environment where the internet is the "go to" place for anyone wishing access to information on proposed or final rules, will all influence whether governmental entities can continue to IBR standards to comply with the TTA, or whether some sort of "pay for play" principle will be approved. Congress may intervene as well, given its current scrutiny of copyright issues, and the sleeper provision that was included in the Pipeline and Hazardous Materials Safety istration (PHMSA) no longer IBR voluntary consensus standards into its regulations unless those standards have been made available free of charge to the public on the Internet. See Section 24 of the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011 (Pub. L. 112-90). Even in light of the legal considerations raised by incorporation by reference of voluntary consensus standards into binding federal regulations, the utilization of such standards as an effective and efficient option for meeting the demand of increased regulation and legislation in occupational safety and health should be ed for the following reasons: (1) the consensus method provides for a balance between competing interests; (2) the voluntary nature of consensus standards enables s to adapt provisions to meet unusual circumstances; and (3) much lower standards development costs are achieved. Governmental agencies such as OSHA, MSHA, and the Environmental Protection Agency should be encouraged to utilize these consensus standards as they provide an efficient and effective alternative to traditional public sector rule making and can ultimately improve occupational and public health, safety and environmental protection in a more timely and cost-effective manner.