Standards Improvement Project-Phase IV

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1904, 1910, 1915, and 1926

[OSHA-2012-0007]

RIN 1218-AC67

Standards Improvement Project—Phase IV

AGENCY:

Occupational Safety and Health Administration (OSHA), Labor.

ACTION:

Final rule.

SUMMARY:

In response to the President's Executive Order 13563, “Improving Regulations and Regulatory Review,” and consistent with Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” OSHA is removing or revising outdated, duplicative, unnecessary, and inconsistent requirements in its safety and health standards. The current review, the fourth in this ongoing effort, the Standards Improvement Project-Phase IV (SIP-IV), reduces regulatory burden while maintaining or enhancing worker safety and health, and improving privacy protections.

DATES:

This rule is effective on July 15, 2019. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of July 15, 2019. There are a number of collections of information contained in this final rule (see Section VI, Paperwork Reduction Act). Notwithstanding the general date of applicability that applies to all other requirements contained in the final rule, affected parties do not have to comply with the collections of information until the Department of Labor publishes a separate notice in the

Federal Register

announcing the Office of Management and Budget has approved them under the Paperwork Reduction Act.

ADDRESSES:

In accordance with 28 U.S.C. 2112(a)(2), the agency designates Edmund C. Baird, Associate Solicitor of Labor for Occupational Safety and Health, Office of the Solicitor, Room S-4004, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, to receive petitions for review of the final rule.

FOR FURTHER INFORMATION CONTACT:

General information and press inquiries:

Mr. Frank Meilinger, OSHA Office of Communications: telephone: (202) 693-1999; email:

meilinger.francis2@dol.gov.

Technical inquiries:

Mr. Vernon Preston, Directorate of Construction: telephone: (202) 693-2020; fax: (202) 693-1689; email:

preston.vernon@dol.gov.

Copies of this

Federal Register

document.

Electronic copies are available at

www.regulations.gov.

This

Federal Register

document, as well as news releases and other relevant information, also are available at OSHA's web page at

www.osha.gov.

SUPPLEMENTARY INFORMATION:

Incorporated Standards

The standards published by the American Thoracic Society (ATS) required in 29 CFR part 1910, subpart Z; the Federal Highway Administration (FHWA) required in 29 CFR part 1926, subpart G; the International Labour Organization (ILO) required in 29 CFR part 1910, subpart Z, 29 CFR part 1915, subpart Z, and 29 CFR part 1926, subpart Z; the International Organization for Standardization (ISO) required in 29 CFR part 1926, subpart W; and the Society of Automotive Engineers (SAE) required in 29 CFR part 1926, subpart W, are incorporated by reference into these subparts with the approval of the

Federal Register

under 5 U.S.C. 552(a) and 1 CFR part 51.

Reasonable Availability and Summary of the Incorporated Standards

American Thoracic Society—IBR Approval for §§ 1910.6 and 1910.1043(h)

The American Thoracic Society (ATS) provides free online public access to view and print a read-only copy of the materials incorporated into 29 CFR part 1910, subpart Z, by this rulemaking. Free online viewing and a printable version of Spirometric Reference Values from a Sample of the General U.S. Population. Hankinson JL, Odencrantz JR, Fedan KB. American Journal of Respiratory and Critical Care Medicine, 159:179-187, 1999, is available at

www.atsjournals.org/.

Section 1910.1043(h)(2)(iii) required that health care providers conducting medical surveillance compare the employee's actual values to the predicted values in appendix C of the standard. NIOSH (CDC/NIOSH, 2003), ATS/ERS (Pellegrino et al., 2005), and ACOEM (Townsend, 2011) all recommend the Third National Health and Nutrition Examination Survey (NHANES III) as the most appropriate reference data set for assessing spirometry results for individuals in the U.S. population. OSHA is now revising this provision to specify use of the NHANES III reference data set and to replace the values currently in appendix C with the NHANES III values, derived from Spirometric Reference Values from a Sample of the General U.S. Population (Hankinson et al., 1999).

The NHANES III data set is the most recent and most representative of the U.S. population (Hankinson et al., 1999). It lists reference values for non-smoking, asymptomatic male and female Caucasians, African Americans, and Mexican Americans aged 8- to 80-years old. Strict adherence to ATS quality control standards ensured optimal accuracy in developing this data set of spirometry values (Hankinson et al., 1999).

Federal Highway Administration—IBR Approval for §§ 1926.200(g)(2) and 1926.201(a)

The Federal Highway Administration (FHWA), United States Department of Transportation provides free online access to view and print a read-only copy of the materials incorporated into 29 CFR part 1926, subpart G, by this rulemaking. Free online viewing and a printable version of the Manual on Uniform Traffic Control Devices for Streets and Highways (MUTCD), 2009 Edition, December 2009 (including Revision 1 dated May 2012 and Revision 2 dated May 2012), is available at

www.fhwa.dot.gov.

Subpart G has required that employers comply with Part VI of MUTCD, 1988 Edition, Revision 3, September 3, 1993 (“1988 Edition”) or December 2000 MUTCD (“Millennium Edition”). OSHA is revising subpart G to update the incorporation by reference of Part 6 of the MUTCD to the November 4, 2009 MUTCD (“2009 Edition”), including Revision 1 and Revision 2, both dated May 2012. This version of the MUTCD aims to expedite traffic, promote uniformity, improve safety, and incorporate technology advances in traffic control device application (74 FR 66730, 77 FR 28455, and 77 FR 28460).

International Labour Organization—IBR Approval for § 1910.6, Appendix E to § 1910.1001, § 1915.5, Appendix E to § 1915.1001, § 1926.6, and Appendix E to § 1926.1101

The International Labour Organization (ILO) provides free online access to view and print a read-only copy of the materials incorporated into 29 CFR part 1910, subpart Z, 29 CFR part 1915, subpart Z, and 29 CFR part 1926, subpart Z, by this rulemaking. Free online viewing and a printable version of the Guidelines for the Use of the ILO International Classification of Radiographs of Pneumoconioses, Revised Edition 2011, Occupational safety and health series; 22 (Rev.2011), is available at

www.ilo.org.

Digital radiography systems are rapidly replacing traditional analog film-based systems in medical facilities, and both the ILO and the National Institute for Occupational Safety and Health (NIOSH) recently published guidelines for digital radiographs (see 81 FR at 68509). OSHA is updating the version of the Guidelines for the Use of ILO Classification of Radiographs of Pneumoconioses to the 2011 version (from the 1980 version), and clarifying that classification must be in accordance with the ILO classification system (rather than “a professionally accepted Classification system”) in appendix E of each of the three asbestos standards (81 FR at 68510).

The International Organization for Standardization and the Society of Automotive Engineers—IBR Approval for Subpart W

The International Organization for Standardization (ISO) provides for purchase materials incorporated into 29 CFR part 1926, subpart W, by this rulemaking. ISO 3471:2008(E), Earth-moving machinery—Roll-over protective structures—Laboratory tests and performance requirements, Fourth Edition, Aug. 8, 2008; ISO 5700:2013(E), Tractors for agriculture and forestry—Roll-over protective structures—Static test method and acceptance conditions, Fifth Edition, May 1, 2013; and ISO 27850:2013(E), Tractors for agriculture and forestry—Falling object protective structures—Test procedures and performance requirements, First Edition, May 01, 2013, are available for purchase at

www.iso.org.

The Society of Automotive Engineers (SAE) provides for purchase materials incorporated into 29 CFR part 1926, subpart W, by this rulemaking. SAE J167, Protective Frame with Overhead Protection-Test Procedures and Performance Requirements, approved July 1970; SAE J168, Protective Enclosures-Test Procedures and Performance Requirements, approved July 1970; SAE J320a, Minimum Performance Criteria for Roll-Over Protective Structure for Rubber-Tired, Self-Propelled Scrapers, revised July 1969 (editorial change July 1970); SAE J334a, Protective Frame Test Procedures and Performance Requirements, revised July 1970; SAE J394, Minimum Performance Criteria for Roll-Over Protective Structure for Rubber-Tired Front End Loaders and Rubber-Tired Dozers, approved July 1969 (editorial change July 1970); SAE J395, Minimum Performance Criteria for Roll-Over Protective Structure for Crawler Tractors and Crawler-Type Loaders, approved July 1969 (editorial change July 1970); SAE J396, Minimum Performance Criteria for Roll-Over Protective Structure for Motor Graders, approved July 1969; and SAE J397, Critical Zone—Characteristics and Dimensions for Operators of Construction and Industrial Machinery, approved July 1969, are available for purchase at

www.sae.org/standards.

The original source standards for subpart W requirements were derived from SAE Standards. The American National Standards Institute (ANSI) and SAE subsequently canceled these standards. To design and develop new equipment, the industry now uses the most recent ISO standards. Equipment manufactured after the effective date of this final rule must meet the applicable test and performance requirements for the ISO standards. Equipment manufactured before the effective date of this final rule must meet the former SAE requirements of subpart W, or the test and performance requirements for the applicable ISO standards that apply to newly manufactured equipment.

ISO 3471:2008(E), Earth-moving machinery—Roll-over protective structures—Laboratory tests and performance requirements, Fourth Edition, Aug. 8, 2008 (“ISO 3471:2008”), IBR approved for §§ 1926.1001(c) and 1926.1002(c), specifies performance requirements for metallic roll-over protective structures (ROPS) for earth-moving machinery, as well as a consistent and reproducible means of evaluating the compliance with these requirements by laboratory testing using static loading on a representative specimen.

ISO 5700:2013(E), Tractors for agriculture and forestry—Roll-over protective structures—Static test method and acceptance conditions, Fifth Edition, May 1, 2013 (“ISO 5700:2013”), IBR approved for § 1926.1002(c), specifies a static test method and the acceptance conditions for roll-over protective structures (cab or frame) of wheeled or tracked tractors for agriculture and forestry.

ISO 27850:2013(E), Tractors for agriculture and forestry—Falling object protective structures—Test procedures and performance requirements, First Edition, May 01, 2013 (“ISO 27850:2013”), IBR approved for § 1926.1003(c), sets forth the test procedures and performance requirements for a falling object protective structure, in the event such a structure is installed on an agricultural or forestry tractor.

SAE J167, Protective Frame with Overhead Protection—Test Procedures and Performance Requirements, approved July 1970, IBR approved for § 1926.1003(b), establishes requirements of a frame including overhead cover for the protection of operators on wheel type agricultural and industrial tractors to minimize the possibility of operator injury resulting from accidental upsets and overhead hazards during normal operation.

SAE J168, Protective Enclosures—Test Procedures and Performance Requirements, approved July 1970, IBR approved for § 1926.1002(b), specifies test procedures and performance requirements for wheel type agricultural and industrial tractors equipped with protective enclosures necessary to fulfill the intended purposes.

SAE J320a, Minimum Performance Criteria for Roll-Over Protective Structure for Rubber-Tired, Self-Propelled Scrapers, revised July 1969 (editorial change July 1970), IBR approved for § 1926.1001(b), provides the testing agency with a means of testing for structural adequacy of a roll-over protective structure (ROPS) design.

SAE J334a, Protective Frame Test Procedures and Performance Requirements, revised July 1970, IBR approved for § 1926.1002(b), establishes requirements of a frame for the protection of operators on wheel type agricultural and industrial tractors to minimize the possibility of operator injury resulting from accidental upsets during normal operation.

SAE J394, Minimum Performance Criteria for Roll-Over Protective Structure for Rubber-Tired Front End Loaders and Rubber-Tired Dozers, approved July 1969 (editorial change July 1970) IBR approved for 1926.1001(b), provides the testing agency with a means of testing for structural adequacy of a roll-over protective structure (ROPS) design.

SAE J395, Minimum Performance Criteria for Roll-Over Protective Structure for Crawler Tractors and Crawler-Type Loaders, approved July 1969 (editorial change July 1970), IBR approved for § 1926.1001(b), provides the testing agency with a means of testing for structural adequacy of a roll-over protective structure (ROPS) design.

SAE J396, Minimum Performance Criteria for Roll-Over Protective Structure for Motor Graders, approved July 1969 (editorial change July 1970), IBR approved for § 1926.1001(b), provides the testing agency with a means of testing for structural adequacy of a roll-over protective structure (ROPS) design.

SAE J397, Critical Zone—Characteristics and Dimensions for Operators of Construction and Industrial Machinery, approved July 1969, IBR approved for § 1926.1001(b), covers

characteristics and dimensions of a critical zone to prevent crushing of an operator during roll-over.

Dates of Approval and Further Availability

The incorporation by reference of materials from the ATS, ILO, FHWA, and ISO is approved by the Director of the Federal Register as of July 15, 2019. The incorporation by reference of the various SAE standards in 29 CFR part 1926, subpart W, was approved by the Director of the Federal Register before January 6, 2015.

All approved material is available for inspection at the OSHA Docket Office (U.S. Department of Labor, 200 Constitution Avenue NW, Room N-3508, Washington DC 20210; telephone 202-693-2350) and is available from the sources listed in 29 CFR 1910.6, 29 CFR 1915.5, and 29 CFR 1926.6. The material is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to

www.archives.gov/federal-register/cfr/ibr-locations.html.

Table of Contents

I. Executive Summary

II. Background

III. Summary and Explanation of the Final Rule

IV. Final Economic Analysis and Final Regulatory Flexibility Act Analysis

V. Legal Considerations

VI. OMB Review Under the Paperwork Reduction Act of 1995

VII. Federalism

VIII. State Plans

IX. Unfunded Mandates Reform Act of 1995

X. Review by the Advisory Committee for Construction Safety and Health

I. Executive Summary

OSHA is making 14 revisions to existing standards in the recordkeeping, general industry, maritime, and construction standards. The purpose of the Standards Improvement Project (SIP) is to remove or revise outdated, duplicative, unnecessary, and inconsistent requirements in OSHA's safety and health standards, which will permit better compliance by employers and reduce costs and paperwork burdens where possible, without reducing employee protections. In fact, many of the revisions in this rulemaking reduce costs while improving worker safety and health or privacy. OSHA is conducting SIP-IV in response to the President's Executive Order 13563, “Improving Regulations and Regulatory Review” (76 FR 3821), and consistent with Executive Order 13777, “Enforcing the Regulatory Reform Agenda” (82 FR 12285). The revisions include an update to the consensus standard incorporated by reference for signs and devices used to protect workers near automobile traffic, a revision to the requirements for roll-over protective structures to comply with current consensus standards, updates for storage of digital x-rays, and the method of calling emergency services to allow for use of current technology. OSHA is also revising two standards to align with current medical practice: A reduction to the number of necessary employee x-rays and updates to requirements for pulmonary function testing. To protect employee privacy and prevent identity fraud, OSHA is also removing from the standards the requirements that employers include an employee's social security number (SSN) on exposure monitoring, medical surveillance, and other records.

SIP rulemakings are reasonably necessary under the Occupational Safety and Health Act of 1970 (OSH Act; 29 U.S.C. 651 et al.) to provide cost savings, or eliminate unnecessary requirements. The agency estimates cost savings and paperwork reductions for SIP rulemakings. The agency estimates that one revision (updating the method of identifying and calling emergency medical services) may increase construction employers' combined costs by about $32,000 per year while two provisions (reduction in the number of necessary employee x-rays and elimination of posting requirements for residential construction employers) provide estimated combined cost savings of $6.1 million annually. This final rule is considered an Executive Order (E.O.) 13771 deregulatory action. Details on OSHA's cost/cost savings estimates for this final rule can be found in the rule's Final Economic Analysis and Final Regulatory Flexibility Act Analysis in this preamble. OSHA has estimated that, at a discount rate of 3 percent over 10 years, 7 percent over 10 years, or 7 percent over a perpetual time horizon, this final rule yields net annual cost savings of $6.1 million per year.

The agency has not estimated or quantified benefits to employees from reduced exposure to x-ray radiation or to employers for the reduced cost of storing digital x-rays rather than x-ray films. The agency has concluded that the revisions are economically feasible and do not have any significant economic impact on small businesses. The Final Economic Analysis in this preamble provides an explanation of the economic effects of the revisions.

II. Background

The purpose of the SIP-IV rulemaking is to remove or revise outdated, duplicative, unnecessary, and inconsistent requirements in OSHA's safety and health standards. The agency believes that improving OSHA standards will increase employers' understanding of their obligations, which will lead to increased compliance, improved employee safety and health, and reduced compliance costs.

In 1995, in response to a Presidential memorandum to improve government regulation,

1

OSHA began a series of rulemakings designed to revise or remove standards that were confusing, outdated, duplicative, or inconsistent. OSHA published the first rulemaking, “Standards Improvement Project, Phase I” (SIP-I) on June 18, 1998 (63 FR 33450).

2

Two additional rounds of SIP rulemaking followed, with final SIP rules published in 2005 (SIP-II) (70 FR 1111) and 2011 (SIP-III) (76 FR 33590).

3

1

Clinton, W.J., Memorandum for Heads of Departments and Agencies. Subject: Regulatory Reinvention Initiative. March 4, 1995.

2

Revisions made by the SIP-I rulemaking included adjustments to the medical-surveillance and emergency-response provisions of the Coke Oven Emissions, Inorganic Arsenic, and Vinyl Chloride standards, and removal of unnecessary provisions from the Temporary Labor Camps standard and the textile industry standards.

3

In the final SIP-II rule published in 2005 (70 FR 1111), OSHA revised a number of provisions in its health and safety standards identified as needing improvement either by the Agency or by commenters during the SIP-I rulemaking. These included updating or removing notification requirements from several standards, updating requirements for first aid kits to reflect newer consensus standards, updating requirements for laboratories analyzing samples under the vinyl chloride standard, and making worker exposure monitoring frequencies consistent under certain health standards, among other things. The final SIP-III rule, published in 2011 (76 FR 33590), updated consensus standards incorporated by reference in several OSHA rules, deleted provisions in a number of OSHA standards that required employers to prepare and maintain written training-certification records for personal protective equipment, revised several sanitation standards to permit hand drying by high-velocity dryers, and modified OSHA's sling standards to require that employers use only appropriately marked or tagged slings for lifting capacities.

As stated above, the President's Executive Order 13563 (E.O.), “Improving Regulations and Regulatory Review,” establishes the goals and criteria for regulatory review, and requires agencies to review existing standards and regulations to ensure that these standards and regulations continue to protect public health, welfare, and safety effectively, while promoting economic growth and job creation. The E.O. encourages agencies to use the best, least burdensome means to achieve regulatory objectives, to perform periodic reviews of existing standards to identify outmoded, ineffective, or burdensome standards,

and to modify, streamline, or repeal such standards when appropriate. The agency believes that the SIP rulemaking process is an effective means to improve its standards.

OSHA advised the Advisory Committee for Construction Safety and Health (ACCSH) at a public meeting held on December 16, 2011, that it intended to review its standards under the SIP criteria, with particular emphasis on construction standards. A transcription of these proceedings (ACCSH Transcript) is available at Docket No. OSHA-2011-0124-0026.

Recognizing the importance of public participation in the SIP process, the agency published a Request for Information (RFI) on December 6, 2012 (77 FR 72781), asking the public to identify standards that were in need of revision or removal, and to explain how such action would reduce regulatory burden while maintaining or increasing the protection afforded to employees. The agency received 26 comments in response to the RFI. Several of the revisions in this rule were recommended in the public comments received in response to the RFI. Other revisions were identified by the agency's own internal review and by ACCSH.

On October 4, 2016, OSHA published a Notice of Proposed Rulemaking (NPRM) titled “Standards Improvement Project—Phase IV” (81 FR 68504). The period for submitting comments was originally 60 days and was extended by 30 days to allow parties affected by the rule more time to review the proposed rule and collect information and data necessary for comments. The comment period ended on January 4, 2017.

4

4

The NPRM was also consistent with Executive Order 13777, “Enforcing the Regulatory Reform Agenda” (82 FR 12285). That Executive Order requires each agency's Regulatory Reform Task Force to identify regulations for “repeal, replacement, or modification” that, among other things, “eliminate jobs, or inhibit job creation;” “are outdated, unnecessary, or ineffective;” or “impose costs that exceed benefits.”

Id.

section 3(d). In OSHA's view, the regulatory provisions identified in the NPRM met those criteria for repeal, replacement, or modification.

OSHA received around 700 submissions on the proposed rulemaking, with many of the submissions containing comments on more than one of the proposed revisions. The proposed revision to the shipyards standard to remove “feral cats” from the definition of “vermin” received over 500 comments in support. The proposed revision to the lockout/tagout standard in general industry received about 150 comments against and seven in favor. The remaining comments cover the other proposed revisions. All significant issues raised in the comments are discussed in the Summary and Explanation of the Final Rule.

OSHA is moving forward with 14 revisions in its recordkeeping, general industry, maritime, and construction standards. OSHA is not moving forward with proposed revisions to the lockout/tagout general industry standard, personal protective equipment fit in construction, the excavation construction standard, or the decompression tables in the underground construction standard. OSHA received requests for a hearing on the proposal regarding the lockout/tagout standard from some commenters that were opposed to that proposal. In light of the information provided by the comments, OSHA is not in a position at this time to make a final decision on this issue. As a result, the agency will further consider this issue in light of the overall standard. As OSHA is not moving forward with the proposed changes to the lockout/tagout standard, the agency determined that a hearing was not required. OSHA describes the revisions, including changes from the proposal and decisions not to move forward on four proposals, in detail in section III, Summary and Explanation of the Final Rule.

III. Summary and Explanation of the Final Rule

A. Revision in Occupational Injuries and Illnesses Recording and Reporting Standards (29 CFR Part 1904)

Subpart C—Recording Forms and Recording Criteria, Recording Criteria for Cases Involving Occupational Hearing Loss in 29 CFR 1904.10

OSHA proposed to revise § 1904.10(b)(6) of the Recordkeeping rule with language that will assist employers to comply with requirements for recording hearing loss. Title 29 CFR 1904.5 applies to the determination criteria for work-relatedness of all occupational injuries and illnesses, including hearing loss. OSHA proposed adding a cross-reference to this section to clarify requirements for physicians or other licensed health care professionals (PLHCPs) when making a determination of work-relatedness for cases of hearing loss. The final rule is identical to the proposal.

The addition of the cross-reference simply emphasizes the pre-existing requirement that, if an event or exposure in the work environment either caused or contributed to the hearing loss, or significantly aggravated a pre-existing hearing loss, the PLHCP, just as anybody else evaluating a case involving hearing loss, must consider the case to be work-related. Ultimately, the employer is responsible for ensuring that the PLHCP applies the analysis in § 1904.5 when evaluating work-related hearing loss, if the employer chooses to rely on the PLHCP's opinion in determining recordability.

Commenters who opposed the addition of this cross-reference at § 1904.10(b)(6) represented employers in manufacturing and construction sectors. These commenters stated that if OSHA intended for § 1904.5, specifically the presumption of work-relatedness, to apply to occupational hearing loss cases, the rulemaking to revise the hearing loss provisions in the rule on recording and reporting occupational injuries and illnesses in 2002 should have contained this explicitly (Occupational Injury and Illness Recording and Reporting Requirements, 67 FR 44037 (July 1, 2002)). (See discussion of specific comments below.) However, OSHA notes that the existing regulatory text of § 1904.10(b)(5) already confirms this where it states, “You must use the rules in § 1904.5 to determine if the hearing loss is work-related.” The addition of the new cross-reference is merely to reduce any existing confusion. OSHA has received compelling evidence from commenters representing workers' unions and the field of audiology that there is confusion about the interpretation of § 1904.10(b)(6) and what definition of work-relatedness applies. The agency believes that the simple addition of this cross-reference to another existing requirement adds clarity for PHLCPs and employers, and after considering the comments on this proposal, OSHA has decided to add the cross-reference to § 1904.5 in § 1904.10(b)(6).

Several commenters expressed support for OSHA's proposed cross-reference to § 1904.5 in § 1904.10(b)(6). The Laborers' Health & Safety Fund of North America (LHSFNA) and North America's Building Trades Union (NABTU) stated that hearing loss among construction workers is severely underreported (OSHA-2012-0007-0742, -0757). NABTU cited the CPWR Center for Construction Research and Training's Fifth Edition of the Construction Chart Book which suggests that rates of hearing loss in the construction industry are elevated significantly beyond the 1,400 cases that BLS reported from 2004 to 2010:

Since employers have no obligation to test workers' hearing (audiometric testing) in construction, even if employees experience noise levels at or above OSHA's PEL, hearing loss in construction is rarely recognized as an

occupational disease. It is not surprising, therefore, that the numbers reported to the BLS show a very low rate of hearing loss, and for this reason hearing loss data for construction are not comparable with data for general industry.

(OSHA-2012-0007-0781). The CPWR Chart Book notes that in the 7 years between 2004 and 2010, the BLS reported 1,400 cases of hearing loss in construction. They contrasted this number with hearing data that are collected by the National Health Interview Survey (NHIS), a large household survey in the U.S. In the NHIS Survey, at least one in five (21.4%) construction workers self-reported some hearing trouble in 2010 (chart 49b). The CPWR Chart Book indicates that this is nearly one-third higher than the proportion of workers with hearing trouble for all industries combined (16.3%). Id.

NABTU stated that the addition of the cross-reference would clarify that a PLHCP has the same responsibilities in evaluating whether hearing loss is work-related as in evaluating any other workplace injury or illness. NABTU added that OSHA's proposed revision to § 1904.10 would provide consistency between standards, and that the clarification would serve to improve reporting of work-related hearing loss (OSHA-2012-0007-0742).

The United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, and Allied Industrial and Service Workers International Union (USW) also supported the addition of the cross-reference. USW described a case involving USW members in which a health care professional consistently ruled that cases of hearing loss were not occupational, even though those workers had experienced high workplace noise levels for years. Each case was instead attributed to loud music, firing a gun while hunting, or some other non-occupational cause (OSHA-2012-0007-0764).

The AFL-CIO stated that:

It appears that many employers are misinterpreting the current language in section 1904.10(b)(6) to allow a physician to use different criteria for determining work-relatedness than are set forth in section 1904.5 of the regulation. This proposal will help to make clear that physicians and other health care professionals must apply the criteria in section 1904.5 of the recordkeeping rule in making determinations whether hearing loss is work-related for the purposes of recording the case on the OSHA 300 log. The recording of such cases will help identify jobs and operations where workers are exposed to excessive levels of noise and assist in efforts to control these exposures to prevent further risk to workers.

(OSHA-2012-0007-0761).

Dr. Alice Suter, Ph.D., provided a link to a position paper from the National Hearing Conservation Association (NHCA), “NHCA Guidelines on Recording Hearing Loss on the OSHA 300 Log.” It states:

Professional reviewers commonly report pressure by their clients to make a determination that an STS [Standard Threshold Shift] is not recordable. Some have been questioned and challenged on every case they have identified as work-related. Others are unsure of their obligations under the OSHA regulations . . . To the extent that STSs are minimized because of reluctance to report them, workers are not getting the necessary counseling, hearing protector checking, and noise control remedies that could prevent further hearing loss.

(OSHA-2012-0007-0767).

In her comments, Dr. Suter stated that (a) the definition of an STS is quite lenient—so any STS is already a significant shift in hearing threshold level; (b) to qualify for recordability, the hearing loss must first exceed a hearing threshold level of 25dB, which is quite a significant level itself; and (c) to be in a hearing conservation program and to have one's hearing tested, workers are, by definition, exposed to levels of 85 dBA or above, where the risk of noise-induced hearing loss is well-known (OSHA-2012-0007-0767).

Several associations representing employer interests in manufacturing and construction industries expressed opposition to this revision. The Construction Industry Safety Coalition (CISC) and the Coalition for Workplace Safety (CWS) believed that the addition of a reference to § 1904.5 at § 1904.10(b)(6) would substantively change the requirements for recording occupational hearing loss cases (OSHA-2012-0007-0753 and -0756). This cross-reference creates no new requirement. In fact, the same cross-reference to § 1904.5 already exists in the language of § 1904.10(b), which is adjacent and immediately prior to § 1904.10(b)(6). Section 1904.10(b)(5) requires the employer to employ the rules of § 1904.5 to ascertain if the hearing loss is work related. The provision also states that the hearing loss must be considered work related if an event or exposure in the work environment either caused or contributed to the hearing loss, or significantly aggravated a pre-existing hearing loss.

The addition of the very same cross-reference in § 1904.10(b)(6) merely ensures consistency between provisions, provides clarity for PLHCPs in the assessment and determination of hearing loss cases, and in no way alters interpretation of the existing regulations under part 1904.

Section 1904.5(a) states that an injury or illness is to be considered work-related if an event or exposure in the work environment either caused or contributed to the resulting condition or significantly aggravated a pre-existing injury or illness. Work-relatedness is presumed for injuries and illnesses resulting from events or exposures occurring in the work environment, unless an exception in § 1904.5(b)(2) specifically applies. Section 1904.5(b)(1) defines the work environment as “the establishment and other locations where one or more employees are working or are present as a condition of their employment.” OSHA sometimes refers to this presumption for injuries and illnesses that occur in the work environment to be work-related as the “geographical presumption.” In their comments, CISC and CWS noted that in OSHA's 2002 preamble to the revision of § 1904.10, the agency stated:

OSHA agrees . . . that it is not appropriate to include a presumption of work-relatedness for hearing loss cases to employees who are working in noisy work environments. It is possible for a worker who is exposed at or above the 8-hour 85 dBA action levels of the noise standard to experience a non-work-related hearing loss, and it is also possible for a worker to experience a work-related hearing loss and not be exposed to those levels.

(OSHA-2012-0007-0753 and -0756 (quoting 67 FR 44037, 44045)). This statement was not addressing the geographic presumption of § 1904.5, but a different presumption—that of work-relatedness whenever the employee was exposed to noise of 85 dBA or greater, as in the 2001 revision of § 1904.10(b)(5). The current regulations do not contain a presumption that hearing loss is work-related when the work environment is loud (85 dBA or greater). The clarification to § 1904.10(b)(6) does not, and could not, create such a presumption.

OSHA clarified in the 2002 rulemaking that § 1904.5 is to be followed when making work-relatedness determinations. 67 FR 44037, 44045. The 2001 version of § 1904.10(b)(5) had created a special rule for noise exposure in the workplace, providing that hearing loss is presumed to be work-related if the employee is exposed to noise in the workplace at an 8-hour time-weighted average of 85 dBA or greater, or to a total noise dose of 50 percent, as defined in 29 CFR 1910.95. For hearing loss cases where the employee is not exposed to this level of noise, the rules in § 1904.5 must be used to determine if the hearing loss is work-related.

Occupational Injury and Illness Recording and Reporting Requirements, 66 FR 5916, 6129 (Jan. 19, 2001). But in 2002, OSHA abandoned the special rule and reverted to treating the determination of work-relatedness of hearing loss as it does for any other injury or illness under the recordkeeping rule: “Therefore, the final rule states that there are

no special rules

for determining work-relationship and restates that

the rule's overall approach to work-relatedness

—that a case is work-related if one or more events or exposures in the work environment either caused or contributed to the hearing loss, or significantly aggravated a pre-existing hearing loss.” 67 FR at 44045 (emphasis added). The text of § 1904.10(b)(5) confirms this: “You must use the rules in § 1904.5 to determine if the hearing loss is work-related.”

OSHA maintains that indeed it is not appropriate to include an outright presumption of work-relatedness for hearing loss cases. For example, as stipulated at § 1904.5(b)(2)(ii), if an employee in a high-noise work environment meets the recording criteria for hearing loss, but a physician discovers that the employee has an inner ear infection that is entirely responsible for the loss, the case would not be considered work-related. OSHA has consistently interpreted § 1904.10(b)(6) this way since 2001:

[T]he provisions allowing for review by a physician or other licensed health care professional allow for the exclusion of hearing loss cases that are not caused by noise exposure, such as off the job traumatic injury to the ear, infections, and the like. OSHA notes that this presumption is consistent with a similar presumption in OSHA's Occupational Noise standard (in both cases, an employer is permitted to rebut this presumption if he or she suspects that the hearing loss shown on an employer's audiogram in fact has a medical etiology and this is confirmed by a physician or other licensed health care professional).

66 FR 5916, 6012. The addition of a cross-reference in § 1904.10(b)(6) adds no new requirement and merely clarifies the existing requirements for PLCHPs, and ultimately employers, in hearing loss case determinations.

The Graphic Arts Coalition (GAC) submitted comments stating that the revision, as proposed, would significantly expand the employer's responsibility for hearing loss that may have just as easily been incurred through workers' off-duty behaviors including the use of “ear buds” or headphones, power tools, lawn mowers, chain saws, or attendance at music or sporting events. GAC stated that this revision would negate workers' non-workplace noise exposures, and increase OSHA recordables and enforcement actions unfairly (OSHA-2012-0007-0737).

But for a case to be presumed work-related, there must be a

causal

connection between the injury or illness and an event or exposure at work. This does not mean that work factors must outweigh non-work factors in causing the injury, or that work factors must be quantifiable,

e.g.,

a 10% or 20% cause, or that work factors must be “significant.” Causality for OSHA recordkeeping purposes is established if work is a cause. In order to further clarify the issue of work-relatedness, in 2001, OSHA entered into a settlement agreement with the National Association of Manufacturers (NAM) to resolve NAM's challenge to the 2001 recordkeeping final rule. The settlement agreement states that “a case is presumed work-related if, and only if, an event or exposure in the work environment is a discernable cause of the injury or illness or of a significant aggravation to pre-existing condition. The work event or exposure need only be one of the discernable causes; it need not be the sole or predominant cause.” Settlement Agreement: Occupational Injury and Illness Recording and Reporting, 66 FR 66943, 66944 (Dec. 27, 2001). As a result, the geographic presumption treats a case as work-related if work is one cause, even if there are also other non-work causes. However, there must be a causal relationship between the injury or illness and a work event; there is no presumption that an injury is work-related simply because it occurs at work (see § 1904.5(b)(2)).

GAC and Formosa Plastics also disagreed specifically with the use of language from Compliance Directive CPL 02-00-135 in the proposed rule preamble, with GAC stating that by incorporating language from a compliance directive into the standard, OSHA would in effect be turning guidance into a requirement (OSHA-2012-0007-0737, -6333). OSHA disagrees. The only revision of the regulatory text is to add the cross-reference to the existing regulatory provision at § 1904.5. OSHA is adding this cross-reference through the use of notice-and-comment rulemaking, in this Standards Improvement Project-IV rulemaking, which is the proper and appropriate way to make changes to the CFR. This cross-reference adds no new requirement for employers, removes ambiguity, and adds clarity to OSHA enforcement policy already currently in place.

The Flexible Packing Association and Bemis Company also submitted comments that emphasized that to enter a hearing conservation program, an employee must be exposed to an 8-hour time-weighted average sound level of 85 dBA or higher (OSHA-2012-0007-0765, -6338). That is correct, under 29 CFR 1910.95(c)(1), and is not being changed by this rulemaking.

The American Petroleum Institute commented that it had no concerns about the proposed cross-reference, but it did have concerns about the language of the compliance directive (OSHA-2012-0007-0766). The only change being made here is the addition of a cross-reference to § 1904.5.

Some organizations that were generally supportive of the cross-reference felt that it could be improved by the addition of further language. The USW suggested that the cross-reference also be included in the occupational noise exposure standard at § 1910.95(g)(8)(ii), as follows: “. . . unless a physician determines

in accord with Section 1904.5

that the standard threshold shift is not work-related or aggravated by occupational noise exposure . . . (bolded italics added)” (OSHA-2012-0007-0764). While OSHA appreciates that suggestion, OSHA is not making any changes to the occupational noise standard that were not proposed in the SIP-IV NPRM.

NIOSH felt that consistency may not be accomplished by simply cross-referencing to § 1904.5, because § 1904.5 differs in some respects from the compliance directive. It is OSHA's regulations that are enforceable, and OSHA is only adding the cross-reference to the existing regulatory definition of work-relatedness here.

NIOSH also made the distinction that:

§ 1904.5 states that determination of whether work “significantly aggravated” a pre-existing illness or injury is made when the work exposure causes one of the following (which would not have occurred simply from the pre-existing condition):

i. Death

ii. Loss of consciousness

iii. One or more days away from work, or days of restricted work, or days of job transfer

iv. Medical treatment or a change in medical treatment.

Occupational noise exposure does not cause i-iv and cross referencing to § 1904.5 may be confusing.

(OSHA-2012-0007-0726). OSHA agrees that § 1904.5(b)(4), which NIOSH cited, is not applicable to hearing loss. However, as explained above, § 1904.10(b)(5) already requires analysis under § 1904.5. OSHA will not be

adding language beyond the cross-reference to the text of § 1904.10(b)(6), and the final text is identical to the proposed text.

B. Revisions in General Industry Standards, Shipyard Standards, and Construction Standards (29 CFR Parts 1910, 1915, and 1926)

1. Subpart Z of Parts 1910, 1915, and 1926—Toxic and Hazardous Substances, Asbestos in 29 CFR 1910.1001, Inorganic Arsenic in 29 CFR 1910.1018, Cadmium in 29 CFR 1910.27, Coke Oven Emissions in 29 CFR 1910.29, Acrylonitrile in 29 CFR 1910.1045, Asbestos in 29 CFR 1915.1001, Asbestos in 29 CFR 1926.1101, Cadmium in 29 CFR 1926.1127.

OSHA proposed three revisions. The first revision was to remove the requirement in several of its standards that employers provide periodic chest X-rays (CXR) to screen for lung cancer. The final rule retains that proposed revision without change. The second revision was to allow employers to use digital radiography and other reasonably-sized standard films for X-rays. The final rule retains that proposed revision without change. The third revision was to update terminology and references to the International Labour Organization (ILO) guidelines included in its asbestos standards (81 FR 68504, 68507-68511). The final rule's language is nearly the same as that originally proposed, but with some minor changes to respond to concerns raised by NIOSH.

Several OSHA standards currently require periodic CXR to screen exposed workers for lung cancer. Since these standards were promulgated, however, large studies with many years of follow-up have not shown a benefit of CXR screening in reducing either lung cancer incidence or mortality (see 81 FR at 68507-68511). As a result, OSHA proposed removing the requirement for periodic CXR in the following standards: 29 CFR 1910.1018, Inorganic Arsenic; § 1910.1029, Coke Oven Emissions; and § 1910.1045, Acrylonitrile. OSHA did not propose to remove the requirement for a baseline CXR in these, or any other, standards, as baseline CXR at pre-placement or at the initiation of a medical surveillance program provides benefits to workers exposed to lung carcinogens, their employers, and healthcare professionals evaluating these workers (see 81 FR at 68509). OSHA also did not propose removing the CXR requirements in standards where CXR is used for purposes other than screening for lung cancer. For example, OSHA is retaining the CXR requirements in the asbestos standards (§§ 1910.1001, 1915.1001, and 1926.1101) to continue screening for asbestosis. OSHA proposed adding the text, “Pleural plaques and thickening may be observed on chest X-rays” in the non-mandatory appendix H of the general industry asbestos standard (§ 1910.1001), as well as the parallel appendices in the Maritime and Construction asbestos standards (§ 1915.1001, appendix I; § 1926.1101, appendix I) (see 81 FR at 68564, 68662, 68684).

OSHA also proposed updating the CXR requirements to allow, but not require, the use of digital CXRs, also referred to as digital radiographs, in the medical surveillance provisions of its inorganic arsenic (§ 1910.1018), coke oven emissions (§ 1910.1029), and acrylonitrile (§ 1910.1045) standards discussed above, and its asbestos (§§ 1910.1001, 1915.1001, 1926.1101) and cadmium (§§ 1910.1027 and 1926.1127) standards. Digital radiography systems are rapidly replacing traditional analog film-based systems in medical facilities, and both the ILO and the National Institute for Occupational Safety and Health (NIOSH) recently published guidelines for digital radiographs (see 81 FR at 68509). In addition, OSHA proposed allowing other reasonably-sized standard X-ray films, such as the 16 inch by 17 inch size, to be used in addition to the 14 inch by 17 inch film specified in some standards. This proposed change would affect the acrylonitrile (§ 1910.1045), inorganic arsenic (§ 1910.1018), coke oven emissions (§ 1910.1029), and asbestos (§§ 1910.1001, 1915.1001, and 1926.1101) standards. Updating this requirement, as proposed, would ensure consistency across standards as well as conformance with current medical practice (81 FR at 68510).

Lastly, OSHA proposed replacement of “roentgenogram” with “X-ray” to reflect current terminology and corrections to remove references to semi-annual exams for certain employees in the coke oven emissions appendices (§ 1910.1029, app. A(VI) and app. B(II)(A)), as these exams were eliminated in the second SIP rulemaking (70 FR 1112). OSHA also proposed making changes to conform to the language used in the ILO's “Guidelines for the use of the ILO International Classification of Radiographs of Pneumoconioses,” which refers to a classification system as applying to CXR, while interpretation refers to the information translated by the physician to the employer. The proposed revisions clarified that classification must be in accordance with the ILO classification system (rather than “a professionally accepted Classification system”) according to the Guidelines for use of the ILO International Classification of Radiographs of Pneumoconioses (revised edition 2011) in appendix E of each of the three asbestos standards (81 FR at 68510).

Comments and Responses on Removing the Requirement To Provide Periodic CXR To Screen for Lung Cancer

OSHA received several comments supporting the proposal to remove the periodic CXR requirement for lung cancer screening from the inorganic arsenic (§ 1910.1018), coke oven emissions (§ 1910.1029), and acrylonitrile (§ 1910.1045) standards. These comments came from organizations representing labor, industry, and NIOSH.

Among labor unions, the Laborers' Health & Safety Fund of North America (LHSFNA) noted, “Chest X-rays are of very little value in lung cancer cases” (OSHA-2012-0007-0757). Similarly, the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (USW) stated, “There is no evidence that ordinary chest x-rays can detect lung cancer in time to affect mortality” (OSHA-2012-0007-0764). The USW noted that low-dose computed tomography (LDCT), unlike CXR, can detect lung cancer while treatable, but brings with it the risk of increased radiation exposure and false positive results. USW further stated that better equipment and protocols have helped with the latter two problems, and that LDCT will continue to improve (OSHA-2012-0007-0764). The USW recommended that OSHA consider adopting LDCT in the future for high-risk populations (OSHA-2012-0007-0764).

North America's Building Trades Unions (NABTU) agreed with OSHA's proposal to remove the periodic CXR requirement, writing, “We agree that it is long past time to remove requirements for CXRs for the screening detection of lung cancer, since they have no benefit and offer only harm” (OSHA-2012-0007-0742). With regard to LDCT, however, NABTU stated that OSHA should replace the CXR requirement with a carefully-monitored LDCT screening requirement:

[W]hile `OSHA will continue to monitor the literature on [whether to continue to require] baseline Chest X-rays', the agency offers no similar assurance about other forms of screening for lung cancer and, in particular, includes an inadequate assessment of the

benefits of LDCT. After citing a Cochran review that is 3 years old and opining that it may take NIOSH years to come up with recommendations, OSHA effectively absolves employers from any requirement to offer an intervention that has been demonstrated to save lives. This clearly violates the intent of the standards and raises the concern that OSHA intends to wait another 30 years before making needed updates.

(OSHA-2012-0007-0742).

NABTU further stated that OSHA is “repeating the mistakes that lead to the CXR requirements and this overdue standard improvement” and should ensure that current medical input is considered in this standard improvement (OSHA-2012-0007-0742). NABTU asserted that LDCT screening for lung cancer has been endorsed by most relevant medical organizations, as prospective studies have demonstrated LDCT to be an effective lung screening method (OSHA-2012-0007-0742). Recognizing the potential for unnecessary biopsies and surgical interventions from LDCT screening, NABTU advocated for LDCT screening only for workers with sufficient smoking history and a history of occupational lung carcinogen exposure (OSHA-2012-0007-0742). NABTU cited the Building Trades National Medical Screening Program (BTMed) as an example, which screens former Department of Energy (DOE) construction workers for lung cancer with LDCT if they meet the following criteria: Age between 50 to 79 years; five years of employment at a DOE site; smoking history of 20 pack-years (number of cigarette packs per day times number of years smoked) or evidence of asbestosis on CXR; and not recently treated for cancer. The findings among 1,300 scanned workers have included 15 Stage 1 lung cancers, two Stage 2 lung cancers, and six Stage 4 lung cancers (OSHA-2012-0007-0742). Based on these data, NABTU urged OSHA to adopt an LDCT screening requirement using the criteria from the BTMed program, and to collaborate with NIOSH and the National Cancer Institute (NCI) to continue to evaluate outcomes and modify LDCT screening requirements (OSHA-2012-0007-0742). NABTU also submitted to the record guidance from the Finnish Institute of Occupational Health (FIOH) and the Lung Cancer Alliance on LDCT screening for asbestos workers (OSHA-2012-0007-0742, Attachments 4 and 5, respectively).

OSHA acknowledges the concerns of NABTU about not replacing the periodic CXR requirement with an appropriate intervention for lung cancer screening. OSHA also appreciates the data shared from the BTMed Program, which appeared to show LDCT as a useful tool for lung cancer detection. However, OSHA believes that the utility of LDCT in occupational lung cancer screening remains a complex issue, as the agency is not aware of any definitive LDCT screening recommendations based upon a large, randomized, controlled study of workers. Instead, the screening recommendations have stemmed from a study of smokers (

i.e.,

the National Lung Screening Trial), as referenced by NABTU (see Aberle, et al., 2011) (OSHA-2012-0007-0742, Attachment 3).

The National Lung Screening Trial enrolled asymptomatic men and women (n=53,454), aged 55 to 74, that were current smokers or former smokers within the last 15 years and had a smoking history of at least 30 pack-years. The participants underwent annual lung cancer screening with either LDCT or chest radiography for three years. The results showed a statistically significant 20 percent relative reduction in lung cancer mortality with LDCT screening (Aberle, et al., 2011) (OSHA-2012-0007-0742, Attachment 3). However, the trial also showed that LDCT screening results in a high false-positive rate; 24.2 percent of the total LDCT screening tests were classified as positive, with 96.4 percent of these positive results ultimately being false positives. In addition, 39.1 percent of the 26,722 (or about 10,450) participants in the LDCT screening group had at least one positive screening result during the study (Aberle, et al., 2011) (OSHA-2012-0007-0742, Attachment 3). Given that only 649 cancers were diagnosed after a positive screening test, and assuming that each of these cancers was in a different participant, it follows that only 6.2 percent of those with at least one positive test were ultimately diagnosed with lung cancer. This means that 36.7 percent of participants in the LDCT screening group had at least one false positive result. Most positive initial screening results in the National Lung Screening Trial—many of which were false positives—were followed up with a diagnostic evaluation that included further imaging and, infrequently, invasive procedures (Aberle, et al., 2011) (OSHA-2012-0007-0742, Attachment 3). The authors noted potentially harmful effects that could result, including overdiagnosis and the development of radiation-induced cancer (Aberle, et al., 2011) (OSHA-2012-0007-0742, Attachment 3).

Based on these findings of the National Lung Screening Trial, the U.S. Preventive Services Task Force (USPSTF), an independent, volunteer panel of national experts in prevention and evidence-based medicine, recommended annual screening for lung cancer with LDCT for adults aged 55 to 80 years with a 30 pack-year smoking history and who either currently smoke or have quit within the past 15 years. Under USPSTF's criteria, screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery (Moyer et al., 2014) (OSHA-2012-0007-0032). However, given the high false positive rate and subsequent imaging and resulting radiation dose in the National Lung Screening Trial, the USPSTF also noted that lung cancer screening with LDCT is not without harm:

The benefit of screening varies with risk because persons who are at higher risk because of smoking history or other risk factors are more likely to benefit. Screening cannot prevent most lung cancer deaths, and smoking cessation remains essential. Lung cancer screening has substantial harms, most notably the risk for false-positive results and incidental findings that lead to a cascade of testing and treatment that may result in more harms, including the anxiety of living with a lesion that may be cancer. Overdiagnosis of lung cancer and the risks of radiation are real harms, although their magnitude is uncertain. The decision to begin screening should be the result of a thorough discussion of the possible benefits, limitations, and known and uncertain harms (Moyer, et al., 2014).

(OSHA-2012-0007-0032).

In addition to the USPSTF, several other organizations have recommended similar lung cancer screening protocols for high-risk smokers, including the American Cancer Society, American College of Chest Physicians, American Society of Clinical Oncology, American Lung Association, National Comprehensive Cancer Network, and the American Association for Thoracic Surgery. Each organization's specific screening recommendations are summarized by the U.S. Centers for Disease Control and Prevention:

www.cdc.gov/cancer/lung/pdf/guidelines.pdf.

OSHA is not aware of any definitive recommendations based on a large, randomized, controlled study examining the benefit of lung cancer screening with LDCT among occupationally-exposed workers. NABTU supplied a report by the FIOH that recommended LDCT screening in asbestos-exposed individuals if their personal combination of risk factors yields a risk for lung cancer equal to that needed for entry into the National

Lung Screening Trial (OSHA-2012-0007-0742, Attachment 4). Similarly, as discussed by NABTU, the National Comprehensive Cancer Network (NCCN), a nonprofit alliance of 27 cancer centers, recommended screening for two high risk groups: (1) Current or former smokers within the last 15 years who are ages 55 to 74 years with a smoking history of 30 pack-years or more; or (2) individuals age 50 years or older with a smoking history of at least 20 pack-years and with one or more additional risk factors; these risk factors include a history of chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis, a history of cancer, a family history of lung cancer, radon exposure, or occupational exposure to asbestos, arsenic, beryllium, cadmium, chromium (VI), nickel, silica, or diesel fumes (see

www.cdc.gov/cancer/lung/pdf/guidelines.pdf

). The former criteria are very similar to those recommended by the USPTF for heavy smokers, while the latter criteria are similar to those used in the NABTU BTMed program: Age 50 to 79 years, not recently treated for cancer, with five years of employment at a Department of Energy (DOE) site and either a 20 pack-year smoking history or evidence of asbestosis on CXR (OSHA-2012-0007-0742).

NABTU submitted to the record a study by McKee et al. (2015, OSHA-2012-0007-0742, Attachment 2) in which individuals meeting either NCCN group 1 or group 2 criteria (see above) were offered an LDCT screening scan between January 2012 and December 2013. The authors examined the lung cancer detection outcomes between the two groups, as “[i]nclusion of the group 2 population into annual lung screening has generated controversy because this group was not formally evaluated in the NLST [National Lung Screening Trial] or other CT lung screening trials” (OSHA-2012-0007-0742, Attachment 2). Of 1,760 persons scanned (1,296 in group 1 and 464 in group 2), there were 481 positive results (365 in group 1 and 116 in group 2). Follow-up data were available for 1,328 (75%) scanned individuals (997 in group 1 and 331 in group 2) and indicated 23 diagnosed cancers (17 in group 1 and six in group 2). Overall, the group 2 results were substantively similar to the group 1 results, for both the rate of positive results and the annualized cancer detection rates. The authors concluded that screening eligibility should be expanded to include group 2 (McKee et al., 2015) (OSHA-2012-0007-0472, Attachment 2).

While the published results of the McKee et al. study are somewhat encouraging for the potential future use of LDCT, OSHA notes that no information was provided about the false positive rate, subsequent imaging or invasive procedures, and cumulative radiation dose received. The 481 positive results among 1,760 persons screened indicates a total positive rate of 27 percent, the majority of which were likely false positives given the 23 diagnosed cancers among the 1,328 persons with follow-up data. In addition, it is unclear the extent to which persons in Group 2 were occupationally exposed, as only 24% (approximately 129) of the 538 persons in Group 2 were reported to have carcinogen exposure (see Fig. 3, OSHA-2012-0007-0472, Attachment 2). The carcinogen itself or the amount of exposure was not specified, and the majority of persons in Group 2 were instead included in the group based on having a history of a chronic lung disease or smoking-related cancer (see Fig. 3, OSHA-2012-0007-0472, Attachment 2). It is also unclear if any of the six people diagnosed with cancer in Group 2 had exposure to an occupational carcinogen. In addition, lung cancer mortality was not studied. Thus, OSHA maintains that additional research, specifically well-conducted, randomized, controlled studies of occupationally-exposed workers, is needed to establish the efficacy of LDCT screening for lung cancer among workers.

OSHA's position is further supported by the 2014 FIOH report, provided by NABTU (OSHA-2012-0007-0742, Attachment 4), and NIOSH. FIOH reviewed the literature on the efficacy of lung cancer screening with LDCT in asbestos-exposed workers, and concluded that lung cancer screening with LDCT should be considered for those persons with prior exposure to asbestos who are at or above the risk threshold (1.34% over 6 years) set for participation in the National Lung Screening Trial (OSHA-2012-0007-0742, Attachment 4). However, FIOH found that none of the risk calculators they examined showed a risk approaching the National Lung Screening Trial risk threshold for a 50-year-old man with a smoking history of 20 pack-years and occupational exposure to asbestos; the risk threshold was exceeded in one risk model for a 60-year-old man with a smoking history of 10 pack-years, asbestos exposure, and a family history of lung cancer (OSHA-2012-0007-0742, Attachment 4). It should be noted that asbestos exposure was not quantified in these risk calculators, with one model based on data from subjects with a minimum duration of five years of employment in an occupation at high risk for asbestos exposure, and the other model based on data from subjects with at least one year of asbestos exposure (OSHA-2012-0007-0742, Attachment 4). Although FIOH recommended that asbestos-exposed individuals be considered for LDCT lung cancer screening if their personal combination of risk factors, particularly smoking history, yields a risk of lung cancer at or above that needed for entry in the National Lung Screening Trial, FIOH also concluded:

Much work remains to be done related to risk estimation for lung cancer screening eligibility, especially the interplay between age, smoking history, other exposures to tobacco smoke, and other risk factors such as occupational history or genetic predisposition. Going forward it is imperative that efforts are focused on answering these key questions about lung cancer risk, patient selection, and the benefits and harms of lung cancer screening in asbestos-exposed adults. (OSHA-2012-0007-0742, Attachment 4).

Industry support for the proposal came from the North American Insulation Manufacturers Association (NAIMA), representing the insulation industry (OSHA-2012-0007-0701). NAIMA noted that OSHA's proposal to remove the periodic CXR requirement for lung cancer screening would “remove costly and burdensome requirements for some” (OSHA-2012-0007-0701).

NIOSH submitted comments to the record supporting OSHA's proposal to remove the CXR requirement for lung cancer screening (other than an initial, baseline CXR) in various standards, re-affirming that “current medical literature does not support the effectiveness of screening for lung cancer with periodic CXR” (OSHA-2012-0007-0726). NIOSH also agreed with OSHA's assessment that existing evidence is insufficient to justify using alternative screening methods to CXR, that it may be years before research can provide a recommendation on the efficacy of LDCT screening, and that further research is needed on the risks associated with LDCT-associated radiation exposure occurring during a screening protocol for workers exposed to lung carcinogens in the workplace (OSHA-2012-0007-0726).

NIOSH encouraged OSHA to track new developments that may eventually justify requirements for lung cancer screening with LDCT in various standards, and pointed to the FIOH recommendations for asbestos-exposed workers, as discussed above (OSHA-2012-0007-0726). NIOSH suggested

that it may, in the future, be possible to conduct lung cancer screening with ultralow-dose computed tomography (CT) with radiation doses similar to conventional CXR (OSHA-2012-0007-0726), pointing to a recent study by Huber et al. (2016) (OSHA-2012-0007-0726, Attachment 3). In this study, the authors examined a lung phantom with multiple nodules of different sizes using both standard CT and ultralow-dose CT, and found that 93.3% of lung nodules were detected with ultralow-dose CT, compared with 95.5% with standard CT (OSHA-2012-0007-0726, Attachment 3). Additional post-processing of imaging improved the detection rate. The authors concluded that lung cancer screening with ultralow-dose CT is feasible, but also acknowledged that the use of a lung phantom was a “major limitation” (OSHA-2012-0007-0726, Attachment 3).

NIOSH suggested that OSHA, in potential future requirements for LDCT screening, consider setting different threshold levels of exposure to occupational carcinogens that trigger screening in nonsmokers compared to smokers (OSHA-2012-0007-0726). NIOSH also noted the importance of appropriate counseling in LDCT screening, as results often lead to repeat CT scans to evaluate changes in nodules over time (OSHA-2012-0007-0726).

OSHA agrees with NIOSH and its statements regarding the need for the agency to stay apprised of developments that may eventually justify the use of LDCT or ultralow-dose CT for lung cancer screening in workers. There are currently no definitive LDCT lung cancer screening recommendations based on a randomized, controlled trial of occupationally-exposed workers. Thus, OSHA believes that additional scientific study of lung cancer screening with LDCT for workers is needed. However, for this rulemaking, the currently available evidence on LDCT screening for lung cancer indicates a high rate of false positive results (as observed in the National Lung Screening Trial) that can lead to unnecessary follow-up and potential harms.

After considering these comments, OSHA has decided to delete the requirement for periodic CXR in 29 CFR 1910.1018, Inorganic Arsenic; § 1910.1029, Coke Oven Emissions; and § 1910.1045, Acrylonitrile. OSHA has also decided not to require the use of LDCT or ultralow-dose CT for periodic lung cancer screening in workers at this time.

Comments and Responses on Allowing Employers To Use Digital Radiography and Other Reasonably-Sized Standard Films for CXR

OSHA received many comments supporting the proposal to allow, but not require, the use of digital CXRs in the medical surveillance provisions of the inorganic arsenic (§ 1910.1018), coke oven emissions (§ 1910.1029), acrylonitrile (§ 1910.1045), asbestos (§§ 1910.1001, 1915.1001, 1926.1101), and cadmium (§§ 1910.1027 and 1926.1127) standards, and to allow the use of other reasonably-sized standard X-ray films. Support was received from NAIMA, NIOSH, NABTU, LHSFNA, and USW (OSHA-2012-0007-0701; -0726; -0742, -0757; and -0764). LHSFNA summarized, “The past few years have brought rapid digitization to the medical industry. The proposed change to allow digital X-ray storage is a necessary consequence of changes in technology” (OSHA-2012-0007-0757). There were no comments opposing the use of digital CXRs or other reasonably-sized standard X-ray films. After considering these comments, OSHA has decided to allow, but not require, the use of digital CXRs in the medical surveillance provisions of the standards listed.

Comments and Response on Updating Terminology and References to the ILO Guidelines

OSHA also received comments on the proposals to replace “roentgenogram” with “X-ray” to reflect current terminology, remove references to semi-annual exams for certain employees in the coke oven emissions appendices (§ 1910.1029, app. A(VI) and app. B(II)(A)), update language to refer to classification (not interpretation), consistent with the ILO Guidelines, and update references to the ILO guidelines in appendix E of each of the three asbestos standards. NAIMA expressed support for updating the terminology and references to the ILO guidelines in the asbestos standards (OSHA-2012-0007-0701). NABTU also expressed support for referencing the updated ILO guidelines (OSHA-2012-0007-0742). After considering these comments, OSHA has decided to finalize its proposals to replace “roentgenogram” with “X-ray” to reflect current terminology, to remove references to semi-annual exams for certain employees in the coke oven emissions appendices (§ 1910.1029, app. A(VI) and app. B(II)(A)), and to refer to only classification.

NIOSH expressed concern that the ILO's 2011 “Classification of Radiographs of Pneumoconioses” allows digital CXRs to be printed out as hard copies and then classified using the ILO's standard image films. NIOSH cited research suggesting that allowing this approach will significantly increase the apparent prevalence of small opacities (Franzblau, et al., 2009) (OSHA-2012-0007-0726, Attachment 4). In the proposal, OSHA recommended that radiographic facilities and physicians “should” follow the NIOSH Guidelines, “Application of Digital Radiography for the Detection and Classification of Pneumoconiosis,” and noted that NIOSH does not recommend using film-based ILO reference radiographs for comparison with digital chest images or printed hard copies of the images (81 FR at 68510). Instead, NIOSH recommended that OSHA require the use of the NIOSH Guidelines, which state that only ILO digital standard images should be used to classify digital CXRs. NIOSH noted that the Department of Labor (DOL) regulations already promulgated by the Office of Workers' Compensation Programs (OWCP) at 20 CFR part 718 are consistent with the NIOSH Guidelines (OSHA-2012-0007-0726).

OSHA has carefully considered this concern and believes that NIOSH has presented compelling evidence, in the research cited and within the OWCP regulation, that digital CXRs should not be printed as a hard copy and then compared to ILO film standard images. As such, OSHA has incorporated the reference to the 2011 ILO guidelines, but has added language reflecting NIOSH's concerns. Specifically, in appendix E to the asbestos standards (§§ 1910.1001, 1915.1001, and 1926.1101), OSHA has added a provision requiring that digitally-acquired chest X-rays be classified using a complete set of ILO standard digital chest radiographic images provided for use with the Guidelines for the Use of the ILO International Classification of Radiographs of Pneumoconioses (revised edition 2011). The classification of digitally-acquired chest X-rays must be performed based on the viewing of images displayed as electronic copies, and not based on the viewing of hard copy printed transparencies of the images. OSHA believes these edits to the regulatory language address NIOSH's concerns and are consistent with the DOL OWCP regulation.

In addition, NIOSH expressed concern that the regulatory language in appendix E of each of the three asbestos standards (§§ 1910.1001, 1915.1001, and 1926.1101) allows CXR classification by a “B-Reader, a board eligible/certified

radiologist, or an experienced physician with known expertise in pneumoconiosis” (see 81 CFR at 68563, 68661, and 68683). NIOSH suggested that OSHA either remove the “experienced physician” or more specifically define the type of expertise in pneumoconiosis that is required to qualify as an “experienced physician” and that would ensure such a physician is able to accurately classify CXRs using the ILO classification system (OSHA-2012-0007-0726). OSHA recognizes NIOSH's concern, and notes that in the new respirable crystalline silica standard, only B-Readers can classify x-rays. See 29 CFR 1910.1053(i)(2)(iii). However, this change to the asbestos standards was not proposed. OSHA will consider making this change in a future rulemaking.

Summary of Changes

As proposed, OSHA is removing the requirement for periodic CXR in the following standards: 29 CFR 1910.1018, Inorganic Arsenic; § 1910.1029, Coke Oven Emissions; and § 1910.1045, Acrylonitrile. OSHA is not removing the requirement for a baseline CXR in these, or any other, standards. OSHA is also not removing the CXR requirements in standards where CXR is used for purposes other than screening for lung cancer; for example, OSHA is retaining the CXR requirements in the asbestos standards (§§ 1910.1001, 1915.1001, and 1926.1101) to continue screening for asbestosis. OSHA is adding the text, “Pleural plaques and thickening may be observed on chest X-rays” in the non-mandatory appendix H of the general industry asbestos standard (§ 1910.1001), as well as appendix I of the maritime and construction asbestos standards (§§ 1915.1001 and 1926.1101, respectively).

OSHA is also updating the CXR requirements to allow, but not require, the use of digital CXRs in the medical surveillance provisions of the inorganic arsenic (§ 1910.1018), coke oven emissions (§ 1910.1029), and acrylonitrile (§ 1910.1045) standards, and the asbestos (§§ 1910.1001, 1915.1001, 1926.1101) and cadmium (§§ 1910.1027 and 1926.1127) standards. In addition, OSHA is allowing other reasonably-sized standard X-ray films, such as the 16 inch by 17 inch size, to be used in addition to the 14 inch by 17 inch film specified in some standards.

Finally, OSHA is replacing “roentgenogram” with “X-ray” to reflect current terminology and is also eliminating references to semi-annual exams for certain employees in the coke oven emissions appendices (§ 1910.1029, app. A(VI) and app. B(II)(A)), as these exams were eliminated in the second SIP rulemaking (70 FR 1112). In appendix E of each of its three asbestos standards, OSHA is updating terminology and clarifying that classification must be in accordance with the ILO classification system according to the Guidelines for the use of the ILO International Classification of Radiographs of Pneumoconioses (revised edition 2011). OSHA is also further specifying that only ILO standard digital chest radiographic images are to be used to classify digital CXRs, and that digital CXRs are not to be printed out as hard copies and then classified.

References

Aberle, R., Adams, A., Berg, C., Black, W., Clapp, J., Fagerstrom, R., et al. (2011). Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening.

N. Engl. J. Med.

365(5): 395-409.

[FIOH] Finnish Institute of Occupational Health (2014). Asbestos, Asbestosis, and Cancer: Helsinki Criteria for Diagnosis and Attribution 2014. Helsinki: FIOH.

Franzblau, A., Kazerooni, E.A., Sen, A., Goodsitt, M.M., Lee, S-Y, Rosenman, K.D., Lockey, J.E., Meyer, C.A., Gillespie, B.W., Petsonk, E.L., Wang, M.L. (2009). Comparison of Digital Radiographs with Film Radiographs for the Classification of Pneumoconiosis.

Acad. Radiol.

16(6): 669-677.

Huber, A., Landau, J., Ebner, L., Butikofer, Y., Leidolt, L., Brela, B., May, M., Johannes, H., Christe, A. (2016). Performance of ultralow-dose CT with iterative reconstruction in lung cancer screening: limiting radiation exposure to the equivalent of conventional chest X-ray imaging.

Eur. Radiol.

26(10): 3643-3652.

[ILO] International Labour Organization (2011). Guidelines for the Use of the ILO International Classification of Radiographs of Pneumoconioses, Revised Edition 2011. Geneva, Switzerland: ILO.

McKee B.J., Hashim, J.A., French R.J., McKee A.B., Hesketh P.J., Lamb, C.R., Williamson, C., Flacke, S., Wald, C. (2015). Experience with a CT Screening Program for Individuals at High Risk for Developing Lung Cancer.

J. Am. Coll. Radiol.

12(2): 192-197.

Moyer, V.A. (2014). Screening for Lung Cancer: U.S. Preventive Services Task Force Recommendation Statement.

Annals. Internal Med,

160 (5).

[NIOSH] National Institute of Occupational Safety and Health (2011). NIOSH Guideline: Application of Digital Radiography for the Detection and Classification of Pneumoconiosis. DHHS (NIOSH) Publication No. 2011-198.

2. Subpart Z of Part 1910—Toxic and Hazardous Substances, Cotton Dust in 29 CFR 1910.1043

OSHA proposed to update the lung-function testing requirements of its cotton-dust standard to align them with current practices and technology. The language of the final rule is slightly changed from that originally proposed in response to comments from NIOSH.

In 1978, OSHA promulgated the standard for occupational exposure to cotton dust at 29 CFR 1910.1043 because workers exposed to cotton dust are at risk of developing the respiratory disease byssinosis (43 FR 27350, June 23, 1978). As described in the preambles to the proposed and final rules, as well as in the preamble to the SIP-IV NPRM, byssinosis is characterized by a continuum of effects (41 FR 56497, 56500-56501, December 28, 1976; 43 FR 27352-27354; 81 FR 68511). The cotton dust standard contains medical-surveillance provisions at 29 CFR 1910.1043(h). These provisions require initial and periodic medical-surveillance examinations that include administration of a medical questionnaire to determine if workers are experiencing symptoms (§ 1910.1043(h)(2)(ii) and (h)(3)(i)). Medical surveillance requirements also include pulmonary function testing (

i.e.,

spirometry testing) to objectively measure lung function and to assess changes in lung function (§ 1910.1043(h)(2)(iii)).

To improve the accuracy and consistency of pulmonary function testing, OSHA mandated specific requirements in the cotton dust standard based on recommendations from the American Thoracic Society (ATS) and the National Institute for Occupational Safety and Health (NIOSH) (43 FR 27391; 29 CFR 1910.1043, appendix D). Since 1978, pulmonary function testing procedures and technology have evolved significantly, and some of the mandates in the cotton dust standard now are outdated. OSHA thus proposed in the SIP-IV NPRM (81 FR 68504) to update the lung function testing requirements for the cotton dust standard to align them with current practices and technology. Three commenters supported OSHA's proposed updates to requirements for pulmonary function testing in the cotton dust standard (NIOSH, OSHA-2012-007-0726; NABTU, OSHA-2012-0007-0742; and Change to Win, OSHA-2012-0007-0759). No comments opposed to these proposed changes were submitted to the rulemaking record. After considering these comments, OSHA has decided to issue this final rule codifying these updates.

Proposed and Final Revisions

OSHA based the proposed revisions to the cotton dust standard pulmonary

function testing requirements on current recommendations from the American Thoracic Society/European Respiratory Society (ATS/ERS), NIOSH, and the American College of Occupational and Environmental Medicine (ACOEM). Each of these organizations is a recognized authority on generally accepted practices in pulmonary function testing. As in the proposal, references to generally accepted practices in this final rule refer to only those practices recommended by ATS/ERS, NIOSH, or ACOEM.

Like other respiratory diseases, byssinosis can slow the speed of expired air and/or reduce the volume of air that can be inspired and then exhaled. To detect and monitor these impairments, spirometry measures the maximal volume and speed of air that is forcibly exhaled after taking a maximal inspiration. Forced Vital Capacity (FVC) is defined as total exhaled volume after full inspiration. Speed of expired air is determined by dividing the volume of air exhaled in the first second,

i.e.,

the Forced Expiratory Volume in One Second (FEV

1

), by the total FVC to give the FEV

1

/FVC ratio. Values obtained from accurate and repeatable spirometry testing are then compared to reference predicted values, which are averages expected for a person of the same gender, age, height, and race as the employee being tested. A spirometry result that is 100 percent of the predicted value for a person of the same gender, age, height, and race indicates that the individual being tested has average lung function (OSHA, 2013). Depending upon the race of the individual and the reference value group being used, an adjustment may need to be made on the basis of race. This issue is discussed at greater length later in this section. Values are also compared to the employee's previous measurements.

Currently, § 1910.1043(h)(2)(iii) requires that health care providers conducting medical surveillance compare the employee's actual values to the predicted values in appendix C of the standard. Appendix C (29 CFR 1910.1043) contains predicted values derived from equations published by Knudson et al. (1976). Currently, NIOSH (CDC/NIOSH, 2003), ATS/ERS (Pellegrino et al., 2005), and ACOEM (Townsend, 2011) all recommend the Third National Health and Nutrition Examination Survey (NHANES III) as the most appropriate reference data set for assessing spirometry results for individuals in the U.S. population. Therefore, OSHA proposed (81 FR 68581) and in this final rule is now revising this provision to specify use of the NHANES III reference data set and to replace the values currently in appendix C with the NHANES III values, derived from Spirometric Reference Values from a Sample of the General U.S. Population (Hankinson et al., 1999), which are incorporated by reference.

The NHANES III data set is the most recent and most representative of the U.S. population (Hankinson et al., 1999). It lists reference values for non-smoking, asymptomatic male and female Caucasians, African Americans, and Mexican Americans aged 8- to 80-years old. Strict adherence to ATS quality control standards ensured optimal accuracy in developing this data set of spirometry values (Hankinson et al., 1999).

Section 1910.1043(h)(2)(iii) currently specifies that the “predicted FEV

1

and FVC for blacks shall be multiplied by 0.85 to adjust for ethnic differences” because the Knudson data set contains reference values only for Caucasians. However, such an adjustment for that race/ethnic group is no longer necessary because the NHANES III data set contains reference values for African Americans. However, the NHANES III data set does not contain reference values for Asian Americans, who typically have smaller lung volumes compared to Caucasians of the same age, height, and gender (Pellegrino et al., 2005). To obtain Asian American reference values, ATS/ERS (Redlich et al., 2014) and ACOEM (Townsend, 2011) recommend that Caucasian reference values for FVC and FEV

1

be multiplied by a factor of 0.88. Therefore, OSHA proposed and this final rule requires use of a 0.88 correction factor to obtain Asian American reference values for the FVC and FEV

1

. Because race does not appear to affect FEV

1

/FVC (ratio), OSHA did not propose and is not requiring to apply a correction factor to Caucasian values to derive a ratio for Asian Americans. If the NHANES data set is updated to include Asian American values in the future, and generally accepted practices endorse that data set for use in the U.S., OSHA will consider revising § 1910.1043(h)(2)(iii) to include that update.

In comments to the record, NIOSH supported use of the NHANES III spirometric reference values instead of the older Knudson 1976 spirometric reference values and the use of a correction factor of 0.88 to reference values for FEV

1

and FVC in Caucasians to determine reference values for Asian Americans (OSHA-2012-0007-0726).

While use of the NHANES III data set will simplify interpretation of spirometry results by providing reference values for more race/ethnic groups, neither the NHANES III nor the correction factor addresses every race/ethnic group. Therefore, OSHA is finalizing the proposed text indicating that FVC, FEV

1

, and FEV

1

/FVC values be compared to “appropriate” race ethnicity specific values. The term “appropriate” includes groups that are not represented in the NHANES III dataset. For example, using Mexican American values for non-Mexican American Hispanic workers may be appropriate. Designations of race/ethnicity are self-reported by workers, and bi-racial or multi-racial workers should select the race/ethnicity category that best describes them. OSHA's guidance document on spirometry testing provides some additional guidance on this topic, including a recommendation to use Caucasian reference values for Native American Indians (OSHA, 2013).

The software for most spirometers includes the NHANES III data set, which is identified as the Hankinson 1999 data set on some spirometers. If software for older spirometers does not include the NHANES III data set, users of those spirometers would be able to access the NHANES III values online through the NIOSH calculator (CDC/NIOSH, 2010). Tables of the NHANES III values are also available in an appendix to OSHA's spirometry guidance for healthcare professionals that is available online (OSHA, 2013). Therefore, NHANES III values are widely available to spirometry providers, including those providers using older spirometers.

Currently, paragraph (h)(2)(iii) requires an evaluation of pulmonary function testing values using predicted values of FVC and FEV

1

, which are the only reference values listed in the tables in current appendix C. The NHANES III reference data set includes the lower limit of normal (LLN) as well as predicted values for FEV

1

, FVC, and the FEV

1

/FVC ratio. The LLN for these spirometry measurements represents the lower fifth percentile of a healthy (normal) population. That is, 95 percent of a healthy (normal) population should have spirometry values above the LLN, and spirometry values below the LLN could be abnormal (OSHA, 2013). Generally accepted practices by ATS/ERS, NIOSH, and ACOEM currently compare spirometry values to the LLN values to identify impaired pulmonary function.

In particular, ATS/ERS (Pellegrino et al., 2005) defines airways obstruction as an FEV

1

/vital capacity (VC) below the LLN. ACOEM (Townsend, 2011) and

NIOSH (CDC/NIOSH, 2003) define borderline airway obstruction as an FEV

1

/FVC below the LLN, with an FEV

1

between the LLN and the predicted value; they define airways obstruction as both FEV

1

/FVC and an FEV

1

below the LLN. ATS/ERS, NIOSH, and ACOEM indicate that an FVC or VC less than the LLN could indicate possible restrictive impairment (Pellegrino

et al.,

2005; Townsend, 2011; CDC/NIOSH, 2003).

Therefore, OSHA proposed and is finalizing (h)(2)(iii) to require an evaluation of FEV

1

, FVC, and FEV

1

/FVC against the LLN and percent predicted values to fully characterize possible pulmonary impairment in exposed workers, which is consistent with generally accepted current practices and supported by NIOSH (OSHA-2012-0007-0726). OSHA's requirement to evaluate the FEV

1

/FVC ratio in addition to FEV

1

and FVC will not affect triggers for changes in medical surveillance frequency or referral for a detailed pulmonary examination, because the standard bases those triggers solely on FEV

1

values.

OSHA also proposed and is finalizing a change in the triggers for the frequency of medical surveillance. Currently, paragraphs (h)(3)(ii)(A) and (B) of the standard require frequency of medical surveillance based in part on whether the FEV

1

is above or below 80 percent of the predicted value. OSHA proposed that the basis for frequency of medical surveillance be changed to whether the FEV

1

is above or below the LLN. As noted above, generally accepted practices currently use the LLN as the basis for classifying possibly abnormal lung function. Pulmonary function normally declines with age, and the LLN better accounts for age-related declines than the current standard (Townsend et al., 2011). There is evidence that the cut-off point used by the standard, 80 percent of the predicted value, can result in erroneous lung function interpretation in adults (Pellegrino et al., 2005). Therefore, OSHA proposed and is now making final the use of the LLN to determine the frequency of lung-function testing.

OSHA also proposed and is now making a correction to § 1910.1043(n)(1). Currently, paragraph (n)(1) specifies that appendices B, C, and D of the cotton dust standard are mandatory. Since OSHA in this rulemaking is removing the old Knudson values from appendix C and reserving the appendix for future use, OSHA is modifying § 1910.1043(n)(1) to now specify that only appendices B and D are mandatory.

OSHA also makes corrections to § 1910.1043, appendix B-II, B, “Occupational History Table.” The table's column titled “Tenure of Employment” contains boxes in which dates of employment are entered. To allow the entry of dates that occurred later than 1999, OSHA proposed to change the dates to “From 19____ or 20____” and “To 19____ or 20____ .” After further consideration, OSHA is finalizing this change, but with an alternation that will make the date entry even more open-ended. The agency is changing the column's two sub-headers to read as follows: “FROM (year)” and “TO (year.)”

In reviewing this appendix, OSHA also noticed additional, minor technical variations from current practice and other similar forms in other health standards. In appendix B-II, A, “Identification,” OSHA is removing the “age last birthday” question because the form already asks for the employee's birthday. Additionally, OSHA is changing the measurement for height to inches (in) from centimeters (cm) and adding that the weight should be listed in pounds (lbs).

Section 1910.1043, appendix D, sets standards for spirometric measurements of pulmonary function. OSHA based the proposed changes to appendix D, which are now finalized, on the most recent spirometry recommendations from ATS/ERS (Miller et al., 2005). Many of these changes reflect advances in spirometry procedures or methods of interpretation.

5

Other changes reflect technological changes associated with the current widespread use of flow-type spirometers, in addition to volume-type spirometers, which were in widespread use in 1978 when OSHA published the current standard, and remain in use today. The changes would apply only to equipment purchased one year or more after OSHA publishes the final standard in the

Federal Register

. This would give time for distributors to exhaust existing stocks and allow medical providers to continue using the older spirometers until they buy new ones in the normal course of business. For equipment purchased on or before the one year anniversary of the

Federal Register

publication date, the original specifications in appendix D continue to apply.

5

Appendix D provides minimal standards that must be employed when making spirometry measurements. Users of appendix D should also consult generally accepted practices from ATS/ERS (Pellegrino et al., 2005; Miller et al., 2005), NIOSH (CDC/NIOSH, 2003), and ACOEM (Townsend, 2011) for a complete list of current spirometry standards. OSHA's spirometry guidance also outlines those practices (OSHA, 2013).

Current appendix D(I)(b) specifies volume capacity for spirometers, and this final rule is changing it from seven to eight liters in appendix (D)(I)(b)(2). Current appendix D(I)(e) specifies flow rates for flow-type spirometers, and the final rule is changing it from 12 to 14 liters per second in D(I)(e)(2). These revisions to appendix D(I)(b) and (e) reflect current recommendations by ATS/ERS (Miller et al., 2005).

Current appendix D(I)(g) requires either a tracing or display, and OSHA is revising this language in appendix D(I)(g)(2) to “paper tracing or real-time display.” When OSHA published the current standard in 1978, a pen linked to a physical strip chart generated tracings of expiration curves on graph paper during pulmonary testing. In contrast, most current flow-type and volume-type spirometers use computer-generated displays of expiration curves projected on the spirometer or on an attached computer screen.

In appendix D(I)(g)(2), OSHA proposed and is adding size specifications for computer-generated displays, the technology most often used today (Miller et al., 2005). An issue that was critical for tracings in 1978, and remains critical for both tracings and displays today, is that they be large enough to allow a technician to easily evaluate the technical acceptability of the expiration during testing. A large real-time display allows the technician to easily view a technically unacceptable expiration and coach the worker to achieve optimal expirations in subsequent attempts. Current appendix D(I)(g) also specifies requirements for paper tracings of the expiration curve, and requires that the tracings be of sufficient size for hand measurements to conform to appendix D(I)(a). OSHA is revising paragraph D(I)(g)(2) to indicate “If hand measurements will be made.” OSHA is making this change because hand measurements are rarely used, and the values currently shown in the expiration curve are usually computer generated today.

Original appendix D(I)(g) also requires the spirometer to display flow versus volume or volume versus time tracings. The revision in appendix D(I)(g)(2) requires the spirometer to display both flow-volume and volume-time curves or tracings during testing. The flow-volume curve emphasizes early expiration and allows the technician to detect problems early in the maneuver (OSHA, 2013). The volume-time curve emphasizes the end of the expiration and allows the technician to coach the patient to achieve a complete expiration

(OSHA, 2013). OSHA is also updating the paragraph to indicate that both types of curves or tracings must be stored and available for recall. This requirement to store curves will allow the assessment of results for acceptability and repeatability, once testing is concluded, and it will also make it possible to include the curves in reports to health care providers who interpret the results (OSHA, 2013).

Current appendix D(I)(h) requires that instruments be capable of accumulating volume for a minimum of 10 seconds and not stop accumulating volume before (1) the volume change for a 0.5-second interval is less than 25 millimeters, or (2) the flow is less than 50 milliliters per second for a 0.5-second interval. As noted by ATS in 1987, these end-of-test criteria, which were first included in the 1979 ATS statement, caused premature termination of exhalation and FVCs that were falsely reduced by as much as 9 percent (ATS, 1987). To avoid such falsely reduced FVCs, ATS defined end-of-test criteria only according to volume change from 1987 onward (ATS 1987, 1994, 2005). Therefore, OSHA is updating the first clause in appendix D(I)(h)(2) by specifying the currently recommended volume change of less than 25 milliliters for a 1-second interval (Miller et al., 2005) and is also removing the latter clause,

i.e.,

that the instrument shall not stop accumulating volume before the flow is less than 50 milliliters per second for a 0.5-second interval. These changes that were proposed and are now final make appendix D consistent with current ATS/ERS recommendations for expiratory end-of-test criteria using volume increment only, since flow rate criteria were abandoned in 1987 (ATS, 1987; Miller et al., 2005). OSHA is also updating this provision by revising the time for which the instrument must be capable of accumulating volume to 15 seconds, the maximum time for which an exhalation should be done according to ATS/ERS (Miller et al., 2005). In 1987, ATS stated that they encourage spirometer designs that allowed patients to continue exhaling for as long as possible (ATS, 1987).

Current appendix D(I)(j), (II)(b), and (IV)(b) provide requirements for the calibration of spirometers, and the final rule updates several of these requirements. Revisions to appendix D(I)(j)(2), (II)(b), and (IV)(b) clarify that the technician must always check the calibration of spirometers, and recalibrate them only if the spirometer requires the technician to do so. That change is consistent with recommendations by ATS/ERS (Miller et al., 2005). The reason for the change is that while technicians cannot recalibrate many spirometer models in current use, they nevertheless must check the volume accuracy of all spirometers; this ensures that the spirometers are operating within calibration limits,

i.e.,

that the spirometers are accurate (OSHA, 2013). In addition, appendix D(II)(b) was revised to indicate that the calibration check is to assess the volume accuracy of the spirometer and that calibration checks be done daily, or more frequently if specified by the spirometer manufacturer when the spirometer is in use. This language, which is more specific than the proposed “check all spirometers regularly,” was suggested by NIOSH, based on ATS/ERS (Miller et al., 2005) recommendations (OSHA 2012-0007-0726). NIOSH also commented that OSHA may want to note that when performing calibration checks, it is the volume accuracy of the spirometer that is being validated (OSHA-2012-0007-0726).

OSHA proposed and is making in the final rule a number of changes to appendix D(I)(j): First, it is not including the following text in appendix D(I)(j)(2) because it is ambiguous and provides no useful information: “. . . with respect to the FEV

1

and FVC. This calibration of the FEV

1

and FVC may be either directly or indirectly through volume and time base measurements.” The second update to appendix D(I)(j)(2) includes the current ATS/ERS requirements for calibration-syringe accuracy and volume displacement (Miller et al., 2005). As noted above, OSHA is revising the term “calibration” to “calibration check.” Another change to paragraph D(I)(j)(2) is to revise the term “calibration source” to “calibration syringe” because a syringe is the only type of calibration source currently used, so specifying a syringe instead of a source would clarify the requirement.

In addition, OSHA changed the word “should” in D(I)(j)(2) to “shall,” so the new D(I)(j)(2) would read, “the volume-calibration syringe shall provide a volume displacement of at least 3 liters and shall be accurate to within ±0.5 percent of 3 liters (15 milliliters).” The phrase “should” sounds advisory, and the current practices OSHA is updating are based on the 3 liter size of the syringe. There were no comments addressing this point.

Current appendix D(II)(b) provides that technicians should perform calibrations using a syringe or other source of at least two liters. The change in the syringe volume to three liters is consistent with current practices. OSHA also is changing the term “syringe or other volume source” to “syringe” for the reasons described above in the discussion of paragraph D(I)(j). Another change to appendix D(II)(b) is to delete the phrase “or method.” The meaning of that phrase is unclear; the sentence is addressing calibration checks of an instrument (

i.e.,

spirometer), not a method. OSHA also is updating calibration check procedures for flow-type and volume-type spirometers to determine whether a spirometer is recording 3 liters (L) of air ±3.5 percent (Miller et al., 2005; OSHA, 2013). The check of flow-type spirometers would involve the injection of air at three different speeds, and the check of volume-type spirometers would involve a single injection of air and a check for spirometer leakage. Users should refer to generally accepted practices and other guidance for complete details about calibration checks (see,

e.g.,

Miller et al., 2005; Townsend, 2011; OSHA, 2013). OSHA is also changing the term “recalibration” in this provision to “calibration checks” for the reasons stated above in the discussion of paragraph D(I)(j). Finally, OSHA is changing “should” to “shall” in the first sentence of D(II)(b) for the same reasons as discussed above regarding paragraph D(I)(j).

Appendix D(II)(a) currently contains requirements for measuring forced expirations, including having the patient make at least three forced expirations. OSHA is updating this paragraph to have the worker perform at least three, but no more than eight, forced expirations during testing. This change would clarify that up to eight forced expirations can be attempted to obtain three acceptable forced expirations (Miller et al., 2005). The same paragraph currently states that “The subject may sit, . . .” OSHA proposed that “subject” be changed to “patient” primarily because “subject” implies someone in an experimental trial. OSHA further considered this proposed change after NIOSH commented that the term “patient” can potentially imply a person with an illness and that a term such as “worker” or “testing participant” may be a better term (OSHA-2012-0007-0726). OSHA has decided that worker is the appropriate term to use since it refers to the individual being tested and has updated appendix D(II)(a) to indicate “worker” instead of “subject.” The terms “patient” or “subject” were also revised to “worker” in appendix D(I)(g)(2), D(III)(a) and D(IV)(c). OSHA also is clarifying the text in paragraph D(II)(a) to indicate that the expiration must be repeatable. The term

“repeatability,” now used by ATS/ERS, would be an update to the existing term “reproducibility”; paragraph D(II)(a)(7) lists the criteria for repeatable (formerly, reproducible) results. In addition, appendix D(II)(a) lists elements of “unacceptable” efforts in paragraphs (a)(1)-(a)(7); OSHA revises this language to “technically unacceptable” to make clear that the problem is not with the worker's lungs but with the flaws in how the test is conducted.

Appendix D(II)(a)(3) currently specifies that a worker's efforts during testing are unacceptable when the expiration does not continue for at least five seconds or until an obvious plateau in the volume-time curve occurs. The revision to this paragraph clarifies that results may be acceptable if the worker

attempted to exhale

(versus actually exhaled) for at least six seconds

and

the volume-time curve shows no change in volume (<0.025 L) for at least one second (Miller et al., 2005). The change was made because OSHA agrees with a NIOSH comment that OSHA should specify the ATS/ERS (Miller et al. 2005) criteria of <0.025 L for at least one second rather than “an obvious plateau” (OSHA-2012-00070-0726). Therefore, the expiration must meet both of these criteria for a spirometry result to be technically acceptable. Many workers who are young or have small lung volumes can complete an expiration in less than six seconds, and their results may be acceptable if the technician observes no change in volume in the volume-time curve (OSHA, 2013).

Current appendix D(II)(a)(4) provides that the results are unacceptable when the worker coughs or closes the glottis during forced expiration. OSHA is revising the paragraph to clarify that the results are unacceptable if coughing occurs in the first second of expiration, a condition that is consistent with current ATS/ERS recommendations (Miller et al., 2005). Coughing in the first second interferes with measurement of the FEV

1

(Miller et al., 2005), but coughing toward the end of the expiration does not affect test results (OSHA, 2013). Glottis closure at any time may result in premature termination of the expiration (Miller et al., 2005).

Current appendix D(II)(a)(6) provides that the results are unacceptable when there is an unsatisfactory start to expiration characterized by excessive hesitation,

i.e.,

one with an extrapolated volume greater than 10 percent of the FVC on the volume-time curve. As noted in the 1987 ATS statement, a criterion of 10 percent could result in a falsely elevated FEV

1

from a suboptimal effort (ATS, 1987). The change to appendix D(II)(a)(6) indicates that extrapolated volume must be less than 150 milliliters or 5 percent of the FVC, whichever is greater, to be unacceptable. This change updates the provision to be consistent with the most recent ATS/ERS recommendation on criteria for start-of-test so that an accurate time zero is set (Miller et al., 2005). All ATS or ATS/ERS statements define acceptable start-of-test criteria according to volume, as well as percent FVC, using whichever criterion is larger for a given patient (ATS, 1979, 1987, 1994; Miller et al., 2005), and it is not clear why the volume value was excluded from the current cotton dust standard. OSHA is also including the 2005 ATS/ERS recommendations for volume, in addition to percentage of FVC, for consistency with ATS/ERS. Expressing the values as both percentage of FVC and as a volume, and using whichever approach gives the larger allowed extrapolated volume, aids in the interpretation of results for individuals with very small or very large lung volumes. For example, since 5 percent of FVC will be less than 150 milliliters in individuals with FVC <3.00 L, the 150 milliliter criterion would be used for those patients. But 5 percent of FVC would exceed 150 milliliters in individuals with FVC >3.00 L, so in that case the 5 percent of FVC criterion would be used to evaluate the start-of-test for these patients.

As stated above, appendix D(II)(a)(7) contains criteria for acceptable repeatability. Editorial changes proposed in appendix D(II)(a)(7) are for clarification. Notably, OSHA removed the word “three” because technicians can examine up to eight acceptable curves to select the two highest FEV

1

and FVC values (Miller et al., 2005). OSHA also changed “variation” to “difference” because “difference” is the more appropriate mathematical term to use when comparing only two numbers.

In appendix D(II)(a)(7), OSHA also revised the maximum difference between the two largest FVC values and the two largest FEV

1

values of a satisfactory test to 150 milliliters, a change from the current maximum difference of 10 percent or ±100 milliliters, whichever is greater. This revision to the criteria for acceptable repeatability reflects current ATS/ERS recommendations (Miller et al., 2005). In 2005, ATS/ERS stated that many patients are able to achieve repeatability of FEV

1

and FVC to within 150 milliliters (Miller et al., 2005). In 1994, the ATS changed its repeatability criterion from a volume and a percentage difference between values to a volume difference only, so that the criterion was equally stringent for all lung sizes, and also so that it was easy to compute during the test if hand-measurements were made (ATS, 1994). OSHA is also making editorial changes to make it clear that the difference between the two largest acceptable FVC values “shall” not exceed 150 milliliters and the two largest acceptable FEV

1

values “shall” not exceed 150 milliliters. OSHA inadvertently proposed that the term “should not exceed” be used, and the agency is revising the term to indicate “shall not exceed.” The change is consistent with other changes being made to this regulation because the word “should” sounds advisory (see,

e.g.,

changes to D(I)(j)(2)).

The agency discussed final changes to appendix D(II)(b) above.

OSHA is removing appendix D(III)(b). The paragraph refers to a NIOSH guideline that specifies an outdated evaluation criterion of FEV

1

/FVC ratio of 0.75 percent, and OSHA is unaware of an updated NIOSH cotton dust guideline that more appropriately compares the FEV

1

/FVC ratio to LLN. As noted above, generally accepted practices use the LLN as the basis for classifying possibly abnormal lung function because it accounts for age-related declines in lung function (Townsend, 2011). Appendix D(III)(b) also refers to a table that OSHA never included in the final cotton dust standard. That table was most likely Table XII-12 in the NIOSH criteria document for cotton dust (CDC/NIOSH, 1974). The lack of the table does not appear to be a pressing issue since no user complained about the missing table after OSHA promulgated the standard. In addition, the information is available to users in the NIOSH criteria document.

The updates to current paragraphs D(IV)(a) and (d) change “reproducibility” to “repeatability” to conform to the terminology now used by ATS/ERS (Miller et al., 2005). “Repeatability” would have the same meaning as “reproducibility.” OSHA also is changing the term “calibration” in paragraph D(IV)(b) to “calibration checks” for the reasons stated above in the discussion of paragraph D(I)(j).

A commenting organization, Change to Win, generally supports OSHA's revisions of the cotton dust standard; however, it articulates the following reservations: (1) The lack of accounting for the “healthy worker effect” seen in epidemiological studies that results from the use of the NHANES population-based data, which may result in “false positives” (

i.e.,

the worker appears to be normal when in

fact they only look normal compared to a “sicker” general population); and (2) the lack of a requirement for the employer to look at results of all the exposed workers to see if trends may indicate an inadequacy of exposure control (OSHA-2012-0007-0759). OSHA appreciates these concerns and acknowledges that some workers may have above average lung function. However, paragraph (h)(3)(iv) requires periodic medical examinations for some workers, including comparisons of current examinations to previous examinations to determine whether significant changes have occurred. This might allow a physician to detect a significant change from baseline lung function in a worker who otherwise has above average lung function compared to a reference population. OSHA agrees that evaluating pulmonary function testing results of all exposed workers may provide useful information for employers and employees; this action is not required by the agency because it goes beyond the scope of this effort, which is to simply update the standard to make it consistent with current practices and technologies.

References

ATS (American Thoracic Society). Medical Section of the American Lung Association (1979). ATS Statement—Snowbird Workshop on Standardization of Spirometry.

Am. Rev. Respir. Dis.,

119, 831-838.

ATS (American Thoracic Society). Medical Section of the American Lung Association (1987). Standardization of Spirometry—1987 Update.

Am. Rev. Respir. Dis.,

136, 1285-1298.

ATS (American Thoracic Society). Medical Section of the American Lung Association (1994). Standardization of Spirometry—1994 Update.

Am. Resp. Crit. Care Med,

152, 1107-1136.

CDC/NIOSH (Centers for Disease Control/National Institute for Occupational Safety and Health) (1974). Criteria for a Recommended Standard: Occupational Exposure to Cotton Dust. Chapter XII: Tables and Figures.

www.cdc.gov/niosh/pdfs/75-118f.pdf.

CDC/NIOSH (Centers for Disease Control/National Institute for Occupational Safety and Health) (2003). Spirometry training guide. December 1, 2003.

www.cdc.gov/niosh/docs/2004-154c/pdfs/2004-154c.pdf.

CDC/NIOSH (Centers for Disease Control/National Institute for Occupational Safety and Health) (2010).

Spirometry reference value calculator. www.cdc.gov/niosh/topics/spirometry/RefCalculator.html.

Hankinson, J.L., Odencrantz, J.R. and Fedan, K.B. (1999). Spirometric reference values from a sample of the general US population.

Am. J. Respir. Crit. Care Med.,

159, 179-87.

Hankinson, J.H., Kawut, S.M. and Shahar, E. (2010). Performance of American Thoracic Society-recommended spirometry reference values in a multiethnic sample of adults.

Chest,

137, 138-145.

Knudson, R.J., Slatin, R.C., Lebowitz, M.D. and Burrows, B. (1976). The maximal expiratory flow-volume curve. Normal standards, variability, and effects of age.

Am. Rev. Respir. Dis.,

113, 587-600.

Miller, M.R., Hankinson, J., Brusasco, V., Burgos, F., Casaburi, R., Coates, A., Wanger, J. (2005). American Thoracic Society/European Respiratory Society (ATS/ERS) Task Force: Standardisation of Spirometry.

Eur. Respir. J.,

26, 319-33,

www.thoracic.org/statements/resources/pfet/PFT2.pdf.

OSHA (Occupational Safety and Health Administration) (2013). Spirometry testing in occupational health programs. Best practices for healthcare professionals. US Department of Labor.

www.osha.gov/Publications/OSHA3637.pdf.

Pellegrino, R., Viegi, G., Brusasco, V., Crapo, R.O., Burgos, F., Casaburi, R. . . . Wanger, J. (2005). ATS/ERS standardisation of lung function testing. Interpretative strategies for lung function tests.

Eur. Respir. J.,

26, 948-968.

Redlich, C.A., Tarlo, S.M., Hankinson, J.L., Townsend, M.C., Eschenbacher, W.L., Von Essen, S.G., Sigsgaard, T. and Weissman, D.N. (2014). American Thoracic Society Committee on Spirometry in the Occupational Setting. Official American Thoracic Society technical standards: Spirometry in the occupational setting.

Am. J. Respir. Crit. Care Med.,

189(8), 983-93.

Townsend, M.C. (2011). American College of Occupational and Environmental Medicine (ACOEM) Occupational and Environmental Lung Disorders Committee. Spirometry in the occupational health setting—2011 Update.

J. Occup. Environ. Med.,

53, 569-584.

www.acoem.org/uploadedFiles/Public_Affairs/Policies_And_Position_Statements/ACOEM%20Spirometry%20Statement.pdf.

3. Subpart F of Part 1915—General Working Conditions, Definitions in 29 CFR 1915.80

Existing requirements in the sanitation standard for Shipyard Employment, § 1915.88(j)(1) and (2), specify that employers must, to the extent reasonably practicable, clean and maintain workplaces in a manner that prevents vermin infestation. When employers detect vermin, they must implement and maintain an effective vermin-control program.

Paragraph (b)(33) of § 1915.80 defines the term “vermin” as “insects, birds, and other animals, such as rodents and feral cats, that may create safety and health hazards for employees.” After stakeholders raised concerns about the inclusion of “feral cats” in the definition of vermin, OSHA proposed to remove the term “feral cats” from the definition in § 1915.80(b)(33). This final rule enacts the proposed removal without change.

OSHA received over 700 comments in response to the NPRM, over 500 of which addressed the removal of the term “feral cats” from the definition of vermin. Each of the comments favored the proposed change. Many of these comments (250) were from a mass mail campaign with the following comment:

Just because these cats aren't pets doesn't mean they're not cared for. Indeed, many shipyard employers and their employees value the cats both for companionship and as a means of controlling rodent populations. Classifying shipyard cats as “vermin” will likely lead to their mistreatment and interfere with the trap-neuter-return (TNR) programs used to manage their numbers and keep the cats healthy. OSHA is a very influential agency. By removing cats from the definition of “vermin,” OSHA is setting an important example for other government agencies to establish policies that more effectively protect cats and promote public health and safety.

Most of the remaining comments contained similar points, such as, OSHA should not classify cats as vermin; cats should be treated humanely; and some cats may be mistreated if OSHA left the definition as is. In addition, commenters stated that cats in fact assist at shipyards in controlling vermin, such as rodents and mice, without the hazards associated with the use of pesticides or chemicals.

After considering these comments, OSHA has decided to remove the term “feral cats” from the definition of vermin in § 1915.80(b)(33). Removing the term “feral cats” is consistent with the general industry sanitation standard provision on vermin, which describes vermin as “rodents, insects, and other vermin” (§ 1910.141(a)(5)). OSHA does not believe that removing the term “feral cats” from the definition will reduce worker health and safety, and notes that feral cats may help reduce the presence of vermin. To the extent feral cats pose a safety or health hazard at any particular shipyard, OSHA will consider the cats to be “other animals” under the standard. The final rule is identical to the proposed rule.

4. Subpart D of Part 1926—Occupational Health and Environmental Controls, Medical Services and First Aid in 29 CFR 1926.50

Under 29 CFR 1926.50, employers must provide specified medical services and first aid to employees to address serious injuries that may occur on the job. Since 1979, OSHA has required the posting of telephone numbers of

physicians, hospitals, or ambulances for worksites located in areas where 911 emergency service is not available. OSHA adopted this requirement when 911 emergency service was still a relatively new concept, and was available only in certain parts of the country. The final rule is identical to the proposed rule.

Today, 911 emergency service is available almost everywhere in North America. In nearly all locations in the United States and Canada, a 911 call over a land-line telephone will link the caller to an emergency-dispatch center. In the United States, most localities with 911 service also have so-called “Enhanced 911,” which will not only connect the land-line caller to a dispatcher, but also will automatically provide the caller's location to the emergency dispatcher. This automatic-location information is critical for emergency responders in cases when the 911 caller does not know his/her exact location, or does not have sufficient time to provide such information.

Although the automatic transmission of location information to emergency dispatchers is customary for land-line telephones, the task of automatically transmitting location information is more complex when the emergency call originates from a wireless telephone. Since 1996, the Federal Communications Commission (FCC) has been phasing in the requirement that wireless carriers adopt technologies that provide 911 caller-location information. The last phase-in benchmark for wireless handsets occurs in January of 2019.

6

As a result, in some remote areas of the country, wireless-telephone carriers still are unable to provide accurate information about the location of the 911 caller to 911 answering centers. OSHA proposed revisions to § 1926.50(f) to update the 911 service-posting requirements consistent with the current status of land-line and wireless-telephone technologies.

6

See

47 CFR 20.18—911 Service.

The proposed revisions addressed the problem of locating callers, usually cell-phone callers, in remote areas that do not have automatic-location capability. In such areas, the proposed revisions required employers to post in a conspicuous location either the latitude and longitude of the worksite or other location-identification information that effectively communicates the location of the worksite. Employers can obtain information about which counties, or portions of counties, are exempted from the 911 location accuracy requirements from FCC PS Docket No. 07-114, which is publicly available on the FCC's Electronic Comment Filing System (ECFS) web page:

apps.fcc.gov/ecfs/proceeding/view?name=07-114.

The proposed revisions also required employers to ensure that the communication system they use to contact ambulance service is effective. Under § 1926.50(e), employers are required to provide a communication system for contacting ambulance service, or proper equipment for transportation of an injured person. When using wireless telephones as a communication system, however, that system's availability varies based on the location of the caller. If an employer is relying upon a communication system at a worksite, it must be effective at the worksite. OSHA did not propose any changes to the requirement to post telephone numbers of physicians, hospitals, or ambulances for worksites located in areas where 911 emergency service is not available.

OSHA received two comments on the revision of § 1926.50, from North America's Building Trades Unions (NABTU) (OSHA-2012-0007-0742) and the Laborers' Health & Safety Fund of North America (LHSFNA) (OSHA-2012-0007-0757). Both comments supported the revision. The comment from LHSFNA noted that “[m]any construction sites are in remote locations (

e.g.,

pipeline work, highway construction and windmill sites) where cell phone coverage is inconsistent. . . .This proposed revision could save many lives on remote construction sites.” After considering these comments, OSHA is revising the standard as proposed in the NPRM. The final rule is identical to the proposed rule.

5. Subpart D of Part 1926—Occupational Health and Environmental Controls, Gases, Vapors, Fumes, Dusts, and Mists in 29 CFR 1926.55

The provisions of § 1926.55 establish permissible exposure limits for numerous toxic chemicals used during construction activities. These provisions are the construction counterpart to the general industry standard at § 1910.1000. OSHA proposed clarifications for several of these provisions, notably paragraphs (a) and (c) and appendix A to § 1926.55. The final rule is identical to the proposed rule, with the addition of an asterisk and a non-substantive, formatting change to appendix A to § 1926.55. OSHA proposed that the phrase “threshold limit values” (TLV) be revised to “permissible exposure limits” (PELs) and that the references to the American Conference of Governmental Industrial Hygienists (ACGIH), in both paragraph (a) and appendix A, be eliminated, as the original language was confusing. While OSHA originally adopted these limits from ACGIH recommendations, the limits are OSHA, not ACGIH, requirements. OSHA received two comments in response to this first proposed revision of § 1926.55. The North American Insulation Manufacturers Association (NAIMA) (OSHA-2012-0007-0701) agreed the current language in the standard is confusing and the proposed revisions were preferable. The American Industrial Hygiene Association (AIHA) supported the change to refer to the limits as PELs but requested that OSHA include a reference to the ACGIH Threshold Limit Values of Airborne Contaminants for 1970 in the standard (OSHA-2012-0007-0734). The comment did not state a reason to maintain the reference to ACGIH. OSHA acknowledges that these PELs are based on the ACGIH values, but these PELs are enforceable OSHA requirements. After considering these comments and to avoid possible confusion, OSHA has decided to revise the standard as proposed to use the phrase “permissible exposure limits” and to not include the references to ACGIH in the regulatory text and appendix A.

Second, the phrase “shall be avoided” in paragraph (a) is confusing as to whether it indicates the provision is mandatory, as intended, or advisory and is not appropriate in regulatory text. OSHA proposed revising this language to read, “An employee's exposure . . . must at no time exceed the exposure limit given for that substance.”

Third, the words “inhalation, ingestion, skin absorption, or contact” in paragraph (a) are redundant and confusing. In addition, the concentrations listed are airborne values, and the standard addresses exposure through any route. OSHA proposed to delete these words.

Fourth, appendix A is not an appendix but an integral part of the standard. To acknowledge this relationship, OSHA proposed to revise the heading to read, “Table A.”

Fifth, appendix A has a column labelled “Skin Designation” under which an “X” demarcates certain substances, although the appendix provides no definition of “X.” The 1970 ACGIH publication, however, notes that the “X” identifies substances that present a dermal hazard. OSHA proposed adding a footnote to appendix A that clarifies the meaning of this designation.

Sixth, appendix A has two footnotes designated by asterisks. However, there

are no asterisks in the body of the table referencing these footnotes. The first footnote, designated by a single asterisk, says, “The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit.” The second footnote, designated by two asterisks, states, “As determined from breathing-zone air samples.” OSHA proposed deleting these two footnotes, and moving the content of the footnotes to paragraphs (a)(1) and (2) of § 1926.55.

Finally, OSHA proposed correcting the cross-references to OSHA's construction asbestos standard in paragraph (c) and in appendix A. The correct cross reference is: § 1926.1101. OSHA also proposed deleting footnote 4, which was also a reference to the asbestos standard, as footnote 4 does not appear in the body of the table.

OSHA received two other comments in response to the proposed revisions of § 1926.55. North America's Building Trades Unions (NABTU) (OSHA-2012-0007-0742) submitted comments generally supporting the revisions. Laborers' Health & Safety Fund of North America (LHSFNA) (OSHA-2012-0007-0757) supported the revisions but requested that OSHA revise appendix A to align them with 2009 NIOSH skin classifications and to add a footnote to appendix A stating that these PELs are from the 1969 threshold limit values and may not be protective. OSHA recognizes that most of its PELs were issued shortly after adoption of the Occupational Safety and Health (OSH) Act in 1970, and have not been updated since that time. However, a standards improvement project is not the appropriate vehicle to change appendix A.

After considering these comments, OSHA is revising the standard as proposed with two additions. First, rather than redesignating appendix A to § 1926.55 as Table A, OSHA is dividing appendix A into two tables and designating them as Tables 1 and 2 of § 1926.55. OSHA is also revising the heading for the footnotes to these tables to correspond with this change. Appendix A did not conform with criteria for presenting tables and footnotes in the Code of Federal Regulations. When appendix A was added to the Code of Federal Regulations in 1993, OSHA adopted the format used in ACGIH's 1970 TLVs (58 FR 35076; 35089-35099). This format presented TLVs for most substances in one table and TLVs for mineral dusts in a separate table, with footnotes following the two tables. Accordingly, OSHA is designating the first table in former appendix A as Table 1, with the title “Permissible Exposure Limits for Airborne Contaminants”, and the second table as Table 2, with the title “Mineral Dusts.” The footnotes are now preceded by the heading “Footnotes to Tables 1 and 2 of this section” to make it clear that the footnotes apply to both tables. This is a non-substantive, formatting revision. Second, OSHA is adding an asterisk to “Skin Designation” in Table 1 to § 1926.55, linked to the footnote about dermal hazards.

6. Subpart D of Part 1926—Occupational Health and Environmental Controls, Process Safety Management of Highly Hazardous Chemicals in 29 CFR 1926.64

To avoid unnecessary duplication, OSHA proposed replacing the entire 31 pages of regulatory text for the Process Safety Management of Highly Hazardous Chemicals (PSM) Standard for construction at § 1926.64 with a cross reference to the identical general industry standard at § 1910.119. The final rule is identical to the proposed rule. Other construction standards have similar cross references to corresponding general industry standards; for example, the Respiratory Protection Standard for construction at § 1926.103 refers to the general industry Respiratory Protection Standard at § 1910.134. The PSM standard has limited applicability to construction, mainly through paragraph (h),

Contractors.

OSHA received three comments on the revision of § 1926.64: The North America's Building Trades Unions (NABTU) (OSHA-2012-0007-0742), the Laborers' Health & Safety Fund of North America (LHSFNA) (OSHA-2012-0007-0757), and the North American Insulation Manufacturers Association (NAIMA) (OSHA-2012-0007-0701). All three comments supported the revision. After considering these comments, OSHA has decided to replace the regulatory text of the PSM Standard for construction with a reference to the identical general industry standard, as proposed. The final rule is identical to the proposed rule.

7. Subpart E of Part 1926—Personal Protective and Life Saving Equipment, Safety Belts, Lifelines, and Lanyards in 29 CFR 1926.104

The breaking strength of a lifeline is the maximum load that it can carry without failing or breaking. The minimum breaking-strength requirement for lifelines in the safety belts, lifelines, and lanyards standard, § 1926.104(c), has been 5,400 pounds. OSHA proposed revising the minimum breaking-strength requirement for these lifelines from 5,400 to 5,000 pounds. The final rule is identical to the proposed rule.

As noted by OSHA in the proposed fall protection standard published on November 25, 1986 (51 FR 42718, 42726), the agency based the 5,400-pound requirement on the breaking strength of the then-available

3/4

-inch diameter manila rope used for body-belt systems and not on the forces generated in a fall. The basis for the requirement of a 5,000 pound minimum breaking-strength for lanyards and vertical lifelines adopted in the final fall protection standard at § 1926.502(d)(9) is the force generated by a 250-pound employee experiencing a force 10 times the force of gravity, plus a two-fold margin of safety. Id. The 5,000 pound requirement is also consistent with the most recent ANSI/ASSE standards Z359.1 2007 and A10.32.

For consistency, OSHA proposed revising the minimum breaking-strength requirement for lifelines in the safety belts, lifelines, and lanyards standard to 5,000 pounds. OSHA received comments on the revision of § 1926.104(c), from the North America's Building Trades Unions (NABTU) (OSHA-2012-0007-0742) and the Laborers' Health & Safety Fund of North America (LHSFNA) (OSHA-2012-0007-0757). Both of these comments supported the revision.

After considering these comments, OSHA is revising the minimum breaking-strength requirement in § 1926.104(c) to 5,000 pounds. This revision conforms § 1926.104(c) with the breaking-strength requirements in the fall protection standard at § 1926.502(d)(9). The agency also concludes that identical specifications for the same equipment eliminate confusion and, thereby, improve compliance. The final rule is identical to the proposed rule.

8. Subpart G of Part 1926—Signs, Signals, and Barricades

Subpart G has required that employers comply with Part 6 of the Manual on Uniform Traffic Control Devices (MUTCD), 1988 Edition, Revision 3, September 3, 1993 (“1988 Edition”) or December 2000 MUTCD (“Millennium Edition”). OSHA proposed to revise subpart G to update the incorporation by reference of Part 6 of the MUTCD to the November 4, 2009 MUTCD (“2009 Edition”), including Revision 1 and Revision 2, both dated May 2012. This version of the MUTCD aims to expedite traffic, promote uniformity, improve safety, and incorporate technology advances in traffic control device application (74 FR 66730, 77 FR 28455, and 77 FR 28460).

The final rule is identical to the proposed rule.

The Department of Transportation (DOT) requires that traffic control signs or devices conform to the 2009 Edition (see 23 CFR 655.601 through 655.603). DOT regulations recognize that the MUTCD is the national standard for all traffic control devices installed on any street, highway, or bicycle trail open to public travel (§ 655.603(a)). DOT requires compliance with the 2009 Edition for all federal-aid construction areas (§ 655.603(d)(3)). In addition, each State must have a highway safety program that complies with DOT's designated national standard, and where State or other federal agency MUTCDs or supplements are required, they shall be in substantial conformance with the 2009 Edition (23 U.S.C. 402(a); 23 CFR 655.603(b)(1)). Substantial conformance means that the State MUTCD or supplement shall conform as a minimum to the standard statements included in the 2009 Edition (§ 655.603(b)).

The differences between OSHA's standards that reference the MUTCD's 1988 Edition and the Millennium Edition and DOT's regulations cause potential industry confusion and inefficiency, without advancing worker safety. Accordingly, in Directive CPL 02-01-054, dated October 16, 2012, OSHA stated that it would accept compliance with the 2009 Edition in lieu of compliance with the 1988 Edition or Millennium Edition referenced in § 1926.200(g) through its

de minimis

policy.

OSHA reviewed the differences between the 1988 Edition, the Millennium Edition, and the 2009 Edition, and has concluded that the 2009 Edition will provide greater employee safety benefits than the older versions. The 2009 revisions to the MUTCD largely make the document more accessible and accounts for advances in technology. A comparison of the 1988 and 2009 Editions shows few new requirements; rather, the document is easier to use, with more guidance and supporting material available. The MUTCD is a complex document comprised of standards, guidance, and supporting material. Under § 1926.6(a), OSHA's subpart G provisions incorporate by reference only the mandatory provisions of the MUTCD,

i.e.,

those provisions containing the word “shall” or other mandatory language, and only those provisions that affect worker safety with regard to the use of signs, devices, barricades, flaggers, and points of hazard. Previously, it was difficult to locate these provisions, but the 2009 Edition clearly labels them “standards.”

The revisions to the 1988 and Millennium Editions that affect worker safety are minimal. DOT identified the following areas as significant revisions that relate to work safety in the final rule (74 FR 66730):

• The needs and control of all road users through a temporary traffic-control (TTC) zone apply to all public facilities and private property open to public travel, in addition to highways.

• Federal Highway Administration (FHWA) allows non-compliant devices on existing highways and bikeways to be brought into compliance with the current edition of the MUTCD as part of the systematic upgrading of substandard traffic control devices (and installation of new required traffic control devices) required pursuant to the Highway Safety Program, 23 U.S.C. 402(a). If the FHWA establishes a target compliance date for upgrading such devices, traffic control devices shall be in compliance by that date. (These target compliance dates established by the FHWA are shown in Table I-2 of the 2009 Edition.)

• Workers within the public right-of-way must use high-visibility safety apparel.

• A new section titled “Automated Flagger Assistance Devices” (AFAD). These optional devices enable a flagger to assume a position out of the lane of traffic when controlling road users through TTC zones.

• New requirements that flaggers shall use a “STOP/SLOW” paddle, flag, or AFAD to control road users; the 2009 Edition prohibits the use of hand movements alone. In the previous editions, it was not clear that hand signals alone were insufficient.

• All devices used for lane channelization (

i.e.,

directing vehicles in a particular direction) must be crashworthy (a characteristic of a roadside appurtenance that has been successfully crash tested in accordance with a national standard such as the National Cooperative Highway Research Program Report 350, “Recommended Procedures for the Safety Performance Evaluation of Highway Features.”)

• Temporary traffic barriers, including their end treatments (such as an impact attenuator), must be crashworthy.

There was one major revision to the MUTCD, the 2003 Edition, between the Millennium Edition and the 2009 Edition. OSHA is providing a list of the changes between the 2003 Edition and the 2009 Edition in the record (find 2009 Edition figure changes at

www.regulations.gov

in Docket No. OSHA-2012-0007).

OSHA also proposed to revise §§ 1926.200 through 1926.203 in subpart G to clarify their provisions and eliminate duplication.

Section 1926.200(g)—Traffic signs.

Existing paragraph (g)(1) of § 1926.200 states, “[c]onstruction areas shall be posted with legible traffic control signs at points of hazard.” Accordingly, paragraph (g)(1) does not explicitly require protection by traffic control devices. However, paragraph (g)(1) requires legible signs at points of hazard, and paragraph (g)(2) prohibits misuse of both signs

and devices,

by requiring their use to conform to the MUTCD. Not requiring employers to use, but prohibiting the

misuse

of, protective devices at points of hazard is an anomaly that causes unnecessary confusion.

OSHA proposed to revise paragraph (g)(1) to explicitly require that employers use traffic control devices at points of hazard. OSHA also proposed to revise paragraph (g)(2) to clarify that it covers the design and use of traffic-control devices, and adds a list of those devices: Signs, signals, markings, barricades, and other devices. Consistent with these revisions, OSHA also proposed to revise the headings of § 1926.200 and paragraph (g) by adding the term “devices” to these headings. The agency will retain the requirement that signs be legible.

Section 1926.201—Signaling.

The agency proposed limiting revisions to § 1926.201 to the 2009 Edition update discussed above.

Section 1926.202—Barricades.

OSHA proposed deleting this section because it duplicates the requirements in the revisions to paragraph (g)(1), which require the use of barricades as traffic control devices at points of hazard, and paragraph (g)(2), which require that the design and use of barricades conform to the updated MUTCD.

Section 1926.203—Definitions applicable to this subpart.

OSHA proposed deleting this section because the MUTCD defines or describes most of the words defined in this section (

e.g.,

barricade, signs, and signals). To the extent that other provisions of subpart G use the defined words but do not reference the MUTCD, providing definitions for these words is unnecessary because the meanings of the words are either obvious or defined in applicable consensus standards or in other OSHA standards; for example, an adequate description of a “tag” is in § 1926.200(h).

OSHA received three comments on the proposed revisions to subpart G. OSHA received a comment of general support from Laborers' Health & Safety

Fund of North America (LHSFNA) (OSHA-2012-0007-0757). A comment from North America's Building Trades Unions (NABTU) (OSHA-2012-0007-0742) supporting the proposed revisions also and requested that OSHA “make clear that these requirements apply not only to flaggers on road construction projects, but also pedestrian employees working in the work zone. Pedestrian workers are at risk of being injured and/or killed by vehicles inside the work zone. Both flaggers and pedestrian workers should be protected by the MUTCD provisions.” The provisions of §§ 1926.200(g) and 1926.201(a) protect all workers in construction areas with exposure to traffic. The signaling provision, § 1926.201(a), instructs flaggers to comply with the MUTCD on signaling and on what garments to wear. Following these provisions protects all workers, not only flaggers. OSHA does not see a need to specifically state in the standard that all workers are protected. OSHA also received a comment from American Road & Transportation Builders Association (ARTBA) (OSHA-2012-0007-0754). This comment supports the revision and states that updating to the newest edition of the MUTCD will alleviate uncertainty and confusion caused by OSHA's reference to multiple versions of the MUTCD in existing standards. The comment also supports OSHA's clarification of the standards related to signage, signaling, and barricades in subpart G.

After considering these comments, OSHA has decided to update the references to the MUTCD in subpart G to the 2009 Edition as well as revise §§ 1926.200 through 1926.203 as proposed. Updating the references to the 2009 Edition MUTCD eliminates confusion as to which edition employers must comply with, and will inform employers that compliance with DOT regulations will not conflict with outdated OSHA regulations. The other revisions clarify subpart G's provisions and eliminate duplication. The final rule is identical to the proposed rule.

In summary, OSHA is revising the safety and health regulations for construction to adopt and incorporate the 2009 Edition of the MUTCD and clarify the regulatory text. The revisions delete the references in §§ 1926.200(g)(2) and 1926.201(a) to the 1988 Edition and Millennium Edition of the MUTCD and insert references to the 2009 Edition. The revisions also revise the regulatory text of paragraphs (g)(1) and (2) of § 1926.200 to eliminate confusion regarding OSHA's interpretation of the existing text. OSHA is deleting § 1926.202 because it duplicates the requirements in the revisions to §§ 1926.200(g) and 1926.203 because the revisions make this section unnecessary.

9. Subpart H of Part 1926—Materials Handling, Storage, Use, and Disposal, General Requirements for Storage in 29 CFR 1926.250

Subpart H of OSHA's construction standards governs the handling, storage, use, and disposal of construction materials on a work site. Section 1926.250 addresses safe storage of building materials inside buildings under construction, and § 1926.250(a)(2) requires employers to post maximum safe load limits of floors in storage areas. This requirement is important during the construction of large buildings because employers often store heavy building materials in these structures on upper floors to accommodate construction staging and schedules. If the weight of stored materials and equipment exceed the maximum safe load limit of the floor, then there is a risk of a localized failure of the floor and structural collapse. However, requiring employers to post safe load limits is unnecessary in residential construction because employers do not place heavy materials in storage areas above floor or slab on grade. Therefore, OSHA proposed revising § 1926.250(a)(2) to exclude residential construction from the posting requirement. The final rule differs from the proposed rule. The final rule uses the term “all single-family residential structures and wood-framed multi-family residential structures” instead of “detached single-family dwellings or townhouses that are under construction.” The final rule also contains organizational changes to the proposed language.

OSHA received three comments on the revision of § 1926.250(a)(2), from the North American Insulation Manufacturers Association (NAIMA) (OSHA-2012-0007-0701), the National Association of Home Builders (NAHB) (OSHA-2012-0007-0747), and the North America's Building Trades Unions (NABTU) (OSHA-2012-0007-0742).

OSHA addresses the comment from NAHB first. The comment supports the proposal to exclude detached, single family residences and townhouses from the load limit posting requirements in § 1926.250(a)(2). NAHB suggests the load limits for floors in residential construction in the United States are uniform and that the weight of materials stored on upper floors are within the safety factor of the supporting material. The comment notes that the International Residential Code (IRC) “has been adopted and is generally used as a base building code standard throughout most of the United States.” The IRC “is a comprehensive, stand-alone residential building code addressing the design and construction of one- and two-family dwellings and townhouses not more than three stories above grade” and “has specific design requirements for live loads (

i.e.,

weight of occupants, furnishings, etc.) placed on floors.” The comment gives an example of what a larger load imposed on an upper floor of a residential home under construction might be: “a stack of 25 (gypsum board or drywall) is well within the inherent factors of safety, particularly since it is only imposing a short-term load.”

While this comment supports OSHA's proposed revisions, it requests that OSHA change “detached single-family dwellings or townhouses that are under construction” to “residential home building” or “residential home construction” to be in line with the language used in OSHA's Compliance Guidance for Residential Construction, STD 03-11-002. “Residential construction” means that the end-use of the building in question must be as a home or dwelling and must be constructed using traditional wood frame construction materials and methods. A comprehensive explanation of OSHA's definition of “residential construction” is in STD 03-11-002, which is located in the docket for this rulemaking.

NAIMA submitted a comment in support of the proposed changes, stating, “safe load limit requirements are unnecessary for single-family home construction as they do not store heavy materials that could endanger employees working at lower levels.”

The agency received a comment opposed to the proposed revisions from NABTU. Their comment states that it is possible that during the construction of townhouses, “one unit may be used as a material depot during the procurement and construction phase.” OSHA understands that it is possible for excessive loads to be stored on any floor during residential construction, but it is not industry practice to store loads for extended periods on the upper floors of the types of residential buildings excepted by this revision. NABTU's comment goes on to say that “[o]btaining maximum safe loads information is not an extra burden on employers.” The fact that employers no longer will need to post signs in storage areas in residential construction does not mean they are relieved of their duty to know the safe load limits and ensure the safety of workers. As noted above,

load limit requirements in residential construction are mostly uniform in the United States, and materials that are typically stored are well within the safety factor. OSHA has requirements that require safe load limits not be exceeded without requiring the posting of such limits. For example, § 1910.22(b) requires that a walking-working surface support the maximum intended load for that surface and does not require the posting of the load limit. Finally, this comment correctly notes that employers must ensure the weight of stored materials does not exceed safe load limits. It also argues that the posting of signs in residential construction “increase awareness” regarding load limits “even if the likelihood is low” for error or incidents. OSHA does not dispute that more information and sign posting in general can increase safety on a job-site, but in this case, the posting of load limits in storage areas of residential construction sites does not increase or decrease the level of safety.

After considering these comments, OSHA is revising § 1926.250(a)(2) to exclude all single-family residential structures and wood-framed multi-family residential structures from the posting requirement. The final revisions to the regulatory text are somewhat different than the revisions in the proposed rule. First, OSHA has named the subsection “Load Limits” for identification purposes. Second, the revision moves the requirement that the weight of storage materials not exceed safe load limits from the end of the subsection to the beginning. This change makes clear that the duty to ensure that any loads placed on floors do not exceed the maximum safe loads of the floors exists regardless of whether or not employers are required to post the safe load limits. Third, the revision changes the style of language used to be more in line with the language used throughout subpart H. Finally, OSHA agrees with the first commenter and has determined that the use of the words “all single-family residential structures and wood-framed multi-family residential structures” is more appropriate than the proposed “detached single-family dwellings or townhouses that are under construction.” OSHA considered using the words “residential construction” to be in line with the language used in 29 CFR part 1926, subpart M, and STD 03-11-002, but this would limit the exception to structures constructed using traditional wood frame construction materials and methods. The revision covers all single-family residential structures, regardless of the materials or methods used during construction, and multi-family residential structures constructed using traditional wood frame construction materials and methods.

OSHA finds that the revision will lessen the compliance burden of employers without jeopardizing the safety of employees. While employers involved in residential construction do not place heavy loads on the floors of these structures, the revision does not relieve employers of the duty to ensure that any loads placed on these floors do not exceed the maximum safe loads of the floors.

10. Subpart S of Part 1926—Underground Construction, Caissons, Cofferdams and Compressed Air, Underground Construction in 29 CFR 1926.800

OSHA has required, under § 1926.800(k)(10)(ii), that mobile diesel-powered equipment used in “other than gassy operations” underground be approved by the Mine Safety and Health Administration (MSHA) in accordance with the provisions of 30 CFR part 32, or that the employer can demonstrate that the equipment is “fully equivalent” to MSHA-approved equipment. In 1996, MSHA revoked part 32 and replaced it with updated provisions in 30 CFR part 7, subpart E, and 30 CFR 75.1909 Non-permissible diesel-powered equipment;

7

design and performance requirements, 75.1910 Non-permissible diesel-powered equipment; electrical system design and performance requirements, and 75.1911 Fire suppression systems for diesel-powered equipment and fuel transportation units (61 FR 55412). Those sections are rules for coal mines. In 2001, MSHA issued 30 CFR 57.5067, which permits operators in metal and nonmetal mines to use engines that meet Environmental Protection Administration (EPA) requirements for engines as an alternative to seeking MSHA approval under part 7, subpart E (66 FR 5706). Under 30 CFR 57.5067, all engines used in underground metal and nonmetal mines must have an affixed plate evidencing approval of the engine pursuant to 30 CFR part 7, subpart E, or meet or exceed the applicable requirements of the EPA listed in MSHA Table 57.5067-1. OSHA proposed to update the regulatory language in § 1926.800(k)(10)(ii) to cross-reference these updated provisions. The final rule contains differences from the proposed rule. The final rule requires compliance only with § 57.5067, pertaining to underground metal and nonmetal mines, and not §§ 75.1909, 75.1910, and 75.1911(a) through (i), pertaining to underground coal mines. The final rule also contains minor technical changes to the proposed language.

7

Non-permissible equipment may not be used in gassy operations.

OSHA received two comments on the proposed changes. One was from Caterpillar Inc. (OSHA-2012-007-0762). That comment supported the changes regarding the substitution of 30 CFR 57.5067 for former part 32, but recommended that OSHA not require compliance with §§ 75.1909, 75.1910, and 75.1911(a) through (i) of part 30. The comment explained that requiring compliance with §§ 75.1909, 75.1910, and 75.1911(a) through (i) of part 30, “would create some conflict or, at the least, confusion . . . and inappropriately add underground coal-mining equipment requirements to equipment used in non-coal environments.”

8

8

OSHA hosted a conference call with Caterpillar to discuss its comment, a summary of which is found in the docket for this rulemaking.

Caterpillar recommended that OSHA not require compliance with §§ 75.1909, 75.1910, and 75.1911(a) through (i) of part 30 because those standards apply to equipment used in underground coal mines, while 30 CFR 57.5067 applies to equipment used in underground metal and nonmetal mines. Caterpillar stated, and the agency agrees, that equipment used for underground construction is more closely related, and often the same, as equipment used in underground metal and nonmetal mines. Caterpillar suggested that OSHA look at alternative standards related to equipment used in underground metal and nonmetal mines (while maintaining that only requiring compliance with 30 CFR 57.5067 regarding engines is necessary), such as 30 CFR 57.14100 through 57.14162—Safety Devices and Maintenance Requirements or 30 CFR 57.5060 through 57.5075—Diesel Particulate Matter—Underground Only. After review of these MSHA standards, OSHA has determined that requiring compliance with either the Safety Devices and Maintenance Requirements or Diesel Particulate Matter—Underground Only standards would go beyond the scope of § 1926.800(k)(10)(ii) and be in conflict with other parts of subpart S. Section 1926.800(k)(10)(ii) is in the ventilation subsection and is concerned with diesel exhaust and compliance with 30 CFR 57.5067 is sufficiently equivalent to the original standard that required compliance with former part 32. Further, requiring compliance with 30 CFR 75.1909, 75.1910, and 75.1911(a) through (i) is

actually inconsistent with 30 CFR 57.5067, as that latter section allows engines to be approved pursuant to 30 CFR part 7, subpart E,

or

meet or exceed the applicable requirements of the EPA listed in MSHA Table 57.5067-1. Therefore, OSHA agrees that the proposed rule is unworkable, and the final rule will require compliance with only 30 CFR 57.5067 as recommended.

Further, OSHA solicited comment on whether employers use the option in the current standard to demonstrate that equipment is “fully equivalent” to MSHA-approved equipment. OSHA received no comment on this provision, therefore all new engines used that are covered by subpart S will have to comply with 30 CFR 57.5067.

The other comment was from the Laborers' Health & Safety Fund of North America (LHSFNA) (OSHA-2012-0007-0757). This comment supported updating the reference to current MSHA regulations, but opposed the grandfathering of older equipment. As OSHA explains below, to avoid the cost of replacing current equipment, OSHA will grandfather older equipment that complies with existing § 1926.800(k)(10)(ii). OSHA notes, however, that 30 CFR 57.5067 was issued seventeen years ago, so the amount of equipment that would not be in compliance with the current requirement is not that large and will continue to diminish.

Based on available information, OSHA has determined that currently manufactured equipment meets the proposed requirements and is generally compliant with the more stringent EPA Tier 3 and Tier 4 emission requirements (ERG, 2015). The agency concludes that all applicable new equipment currently available in the market meets the final rule requirements. OSHA recognizes that there may be some employers using equipment that predates the newer MSHA standards, and the EPA requirements referenced in them. To avoid the costs of replacing existing equipment in use that are compliant with the current standard, the agency proposes to allow equipment purchased before the effective date of the final rule to continue to comply with the terms of existing § 1926.800(k)(10)(ii) (including having been approved by MSHA under 30 CFR part 32 (1995) or be determined to be equivalent to such MSHA-approved equipment).

Finally, the comment from Caterpillar pointed out that 100 ft

3

equals 2.832 m

3

(not 28.32 m

3

as stated in the existing and proposed regulatory text) and suggested a reorganization of the regulatory text for clarity. The agency agrees with this suggestion and has made the applicable change to § 1926.800(k)(10)(ii) in the final rule.

11. Subpart W of Part 1926—Rollover Protective Structures; Overhead Protection

Provisions in subpart W specify minimum performance criteria for rollover protective structures (ROPS) and overhead protection on construction equipment. The agency proposed to revise the existing standards in 29 CFR 1926.1000, 1926.1001, 1926.1002, and 1926.1003 by removing the provisions that specify the test procedures and performance requirements, and replacing those provisions with references to the underlying consensus standards from which they were derived. The substantive differences between the consensus standards and OSHA's standards are minimal. The agency also proposed to remove irrelevant text from § 1926.1000. The final rule is identical to the proposed rule except for the addition of ISO 3471:2008 to § 1926.1002 and other technical corrections. While reviewing the incorporated material for this section OSHA found outdated references to former 29 CFR 1926.1501 in § 1926.6. OSHA is removing those references in this final rule.

The original source standards for the current subpart W requirements are the Society of Automotive Engineers (SAE) Standards J320a-1970, J394-1970, J395-1970, J396-1970, J334a-1970, J167-1970, J168-1970, and J397-1969. The American National Standards Institute (ANSI) and SAE subsequently canceled these standards. To design and develop new equipment, the industry no

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