Standards Improvement Project-Phase IV

Federal RegisterOct 4, 2016

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1904, 1910, 1915, and 1926

[Docket No. OSHA-2012-0007]

RIN 1218-AC67

Standards Improvement Project-Phase IV

AGENCY:

Occupational Safety and Health Administration (OSHA), Labor.

ACTION:

Proposed rule; request for comments.

SUMMARY:

In response to the President's Executive Order 13563, “Improving Regulations and Regulatory Review,” the Occupational Safety and Health Administration (OSHA) is continuing its efforts to remove or revise outdated, duplicative, unnecessary, and inconsistent requirements in its safety and health standards. The current review, the fourth in this ongoing effort, is called Standards Improvement Project-Phase IV (SIP-IV). The goal of the proposed rulemaking is to reduce regulatory burden while maintaining or enhancing employees' safety and health. SIP-IV focuses primarily on OSHA's construction standards.

DATES:

Submit comments and hearing requests by December 5, 2016. All submissions must bear a postmark or provide other evidence of the submission date.

ADDRESSES:

Submit comments and additional material using any of the following methods:

Electronic.

Submit comments and attachments electronically via the Federal eRulemaking Portal at

http://www.regulations.gov.

Follow the instructions online for making electronic submissions.

Facsimile.

Commenters may fax submissions, including any attachments that are no longer than 10 pages in length to the OSHA Docket Office at (202) 693-1648; OSHA does not require hard copies of these documents. Commenters must submit lengthy attachments that supplement these documents (

e.g.,

studies, journal articles) to the OSHA Docket Office, Technical Data Center, Room N-2625, U.S. Department of Labor, 200 Constitution Ave. NW., Washington, DC 20210. These attachments must clearly identify the commenter's name, date, subject, and docket number (

i.e.,

OSHA-2012-0007) so the Agency can attach them to the appropriate comments.

Regular mail, express mail, hand (courier) delivery, or messenger service.

Submit a copy of comments and any additional material (

e.g.,

studies, journal articles) to the OSHA Docket Office, Docket No. OSHA-2012-0007, Technical Data Center, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-2350 (TDY number: (877) 889-5627). Note that security procedures may result in significant delays in receiving comments and other written materials by regular mail. Contact the OSHA Docket Office for information about security procedures concerning delivery of materials by express mail, hand delivery, or messenger service. The hours of operation for the OSHA Docket Office are 8:15 a.m.-4:45 p.m., e.t.

Instructions.

All submissions received must include the Agency name and the docket number for this rulemaking (

i.e.,

OSHA-2012-0007). OSHA places all submissions, including any personal information provided, in the public docket without change; this information will be available online at

http://www.regulations.gov.

Therefore, the Agency cautions commenters about submitting information they do not want made available to the public, or submitting comments that contain personal information (either about themselves or others) such as Social Security numbers, birth dates, and medical data.

OSHA requests comments on all issues related to this proposed rule, including whether these revisions will have any economic, paperwork, or other regulatory impacts on the regulated community.

Docket.

To read or download submissions or other material in the docket (including material referenced in the preamble), go to

http://www.regulations.gov,

or contact the OSHA Docket Office at the address listed above. While the Agency lists all documents in the docket in the

http://www.regulations.gov

index, some information (

e.g.,

copyrighted material) is not publicly available to read or download through this Web site. All submissions, including copyrighted material, are accessible at the OSHA Docket Office. Contact the OSHA Docket Office for assistance in locating docket submissions.

FOR FURTHER INFORMATION CONTACT:

Press inquiries.

Contact Frank Meilinger, Director, OSHA Office of Communications, Room N-3647, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-1999; email:

meilinger.francis2@dol.gov.

General and technical information.

Contact Blake Skogland, Office of Construction Standards and Guidance, OSHA Directorate of Construction, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-3468, Washington, DC 20210; telephone: (202) 693-2020; fax: (202) 693-1689; email:

skogland.blake@dol.gov.

Copies of this

Federal Register

notice.

Electronic copies are available at

http://www.regulations.gov.

This

Federal Register

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

http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

II. Background

III. Summary and Explanation of the Proposed Rule

IV. Preliminary Economic Analysis and 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

XI. Public Participation

I. Executive Summary

OSHA is proposing 18 revisions to existing standards in its recordkeeping, general industry, maritime, and construction standards, with most of the revisions to its construction standards. The purpose of Standards Improvement Projects (SIPs) 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. OSHA is conducting SIP-IV in response to the President's Executive Order 13563, “Improving Regulations and Regulatory Review” (76 FR 38210). OSHA would update three standards to align with current medical practice, including a reduction to the number of necessary employee x-rays, updates to requirements for pulmonary function testing, and updates to the table used for decompression of employees during underground construction. Additionally, the proposed 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, and a revision to lockout/tagout requirements in response to a court decision, among others. OSHA is also proposing to remove from its standards the requirements that employers include an employee's social security number (SSN) on exposure monitoring, medical surveillance, and other records in order to protect employee privacy and prevent identity fraud.

SIP rulemakings do not address new significant risks or estimate benefits and economic impacts of reducing such risks. Overall, SIP rulemakings are reasonably necessary under the OSH Act because they provide cost savings, or eliminate unnecessary requirements. The Agency does estimate cost savings and paperwork reductions for SIP rulemakings. The Agency has estimated that one revision (updating the method of identifying and calling emergency medical services) may increase construction employers costs by about $28,000 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 costs savings of $3.2 million annually. 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, among others. The Agency has preliminarily concluded that the proposed revisions are economically feasible and do not have any significant economic impact on small businesses. The Preliminary Economic Analysis in this preamble provides an explanation of the economic effects of the proposed 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, improve employee safety and health, and reduce compliance costs.

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

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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).

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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.

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In the final SIP-II rulemaking 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, 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,” sets out 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 and 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. As discussed below, several of the proposed amendments contained in this proposed rule were recommended in the public comments received in response to the RFI. Other proposed SIP amendments were identified by the Agency's own internal review and by ACCSH.

III. Summary and Explanation of the Proposed Rule

OSHA is proposing a number of actions amending its standards, including revisions to its general industry, maritime, and construction standards. A detailed discussion of each of the proposed revisions follows, including a discussion of comments the Agency received in response to the RFI. Some of the proposed revisions affect more than one industry (

i.e.,

general industry, construction). When proposed revisions to a general industry standard would affect additional industries, OSHA will discuss the revisions fully in the general industry section and then reference the provisions affected in the sections covering the other industries.

A. Proposed 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

The provisions of 29 CFR part 1904 provide for the recording and reporting of occupational injuries and illnesses. Section 1904.10 sets out the recordkeeping criteria for recording cases involving occupational hearing loss. Current § 1904.10(b)(6) provides that “[i]f a physician or other licensed health care professional determines that a hearing loss is not work-related or has not been significantly aggravated by occupational noise exposure, [the employer is] not required to consider the case work-related or to record the case on the OSHA 300 log.” Section 1904.5 provides the requirements for determining whether an injury or illness is work-related.

To clarify the relationship between §§ 1904.10(b)(6) and 1904.5, OSHA incorporated the following language

into the recordkeeping compliance directive:

Physician or other licensed health care professional (PLHCP) must follow the rules set out in 1904.5 to determine if the hearing loss is 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 PLHCP must consider the case to be work-related. It is not necessary for work to be the sole cause, or the predominant cause, or even a substantial cause of the hearing loss; any contribution from work makes the case work-related. The employer is responsible for ensuring that the PLHCP applies the analysis in Section 1904.5 when evaluating work-related hearing loss, if the employer chooses to rely on the PLHCP's opinion in determining recordability.

(CPL 02-00-135, Chapter 5, Section IX, Question 10-4, 01/12/2012.)

In this rulemaking, OSHA is proposing to add a specific cross reference to § 1904.5 in paragraph § 1904.10(b)(6) to make the language in § 1904.10(b)(6) consistent with the above-quoted language from the compliance directive. The reference specifies that employers must comply with the provisions of § 1904.5 when making a determination of whether a worker's hearing loss is work-related. OSHA believes the proposed revision will assist employers in complying with the hearing-loss recording requirement.

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

1. Subpart J of 1910—General Environmental Controls, Control of Hazardous Energy (Lockout/Tagout) in 29 CFR 1910.147

The Control of Hazardous Energy (Lockout/Tagout) standard, 29 CFR 1910.147, establishes requirements for the control of hazardous energy, including electrical, pneumatic, mechanical, hydraulic, chemical or thermal energy, during the servicing and maintenance of machinery and equipment. Workers who service equipment without preventing the discharge of this energy can be electrocuted or suffer burns, amputations, lacerations, bone fractures, or crushing injuries, among others.

According to its terms, the lockout/tagout standard applies to servicing and maintenance operations “in which the

unexpected

energization or startup of the machines or equipment, or the release of stored energy could cause injury to employees” (§ 1910.147(a)(1)(i) (emphasis in original)). Because OSHA believes the term “unexpected” has been misinterpreted to exclude some operations where employees are subject to injury from startup or the release of stored energy, the Agency is proposing to remove the word from § 1910.147(a)(1) and several other places it appears in the standard (§§ 1910.147(a)(2)(iii)(A), (a)(3)(i), (b), (c)(1), (c)(4)(i), (f)(4), and in Appendix A). The lockout/tagout standard was designed to protect workers from being injured if a machine or other piece of equipment they are servicing releases stored energy, for example, by starting or moving during the servicing. The standard protects these employees by requiring that machines or equipment be de-energized and locked or tagged out

by the worker performing the servicing or maintenance

before the work is performed. The essence of the standard's protection is that a de-energized machine or piece of equipment

cannot

be restarted unless the worker servicing it personally removes the lockout or tagout device he or she has applied.

Thus, OSHA intended the phrase “unexpected energization” to mean any re-energization or startup that occurs before the servicing employee removes the lockout/tagout device from the energy isolation device or equivalent energy control mechanism.

In line with this intent, OSHA has historically interpreted the term “unexpected energization” to mean energization that is unintended or unplanned

by the servicing employee

(72 FR 72452, 72496, December 20, 2007; CPL 02-00-147). OSHA believes that preventing this type of unintended or unplanned energization during servicing is necessary to fully effectuate the standard's purpose of protecting workers through the control of hazardous energy. (

See

CPL 02-00-147,

The Control of Hazardous Energy—Enforcement Policy and Inspection Procedures at 3-1

(Feb. 11, 2008) (“Quite simply, the [lockout/tagout] standard is violated when an employee is, or may be, exposed to hazardous energy that has not been isolated, even if the employee knows that the energy has not been controlled and continues to constitute a hazard.”))

Several decisions of the Occupational Safety and Health Review Commission (OSHRC) support this interpretation. In

Burkes Mechanical, Inc.,

21 BNA OSHC 2136, 2139 & n.4 (No. 04-0475, 2007), OSHRC rejected an argument that the lockout/tagout standard did not apply to employees who were servicing conveyor equipment that was operating. The fact that they knew the equipment was moving did not mean that the hazard fell outside the scope of the standard. Similarly, OSHRC found the standard applied in

Otis Elevator Co.,

24 BNA OSHC 1081 (No. 09-1278, 2013),

aff'd,

762 F.3d 116 (D.C. Cir. 2014), where an employee was trying to unjam the stuck gate assembly of an elevator car without proper energy control measures in place. The energization was unexpected because, although the worker knew the gate assembly would start to move when unjammed, he could not predict when it would become unjammed. The United States Court of Appeals for the District of Columbia Circuit affirmed OSHRC's decision for the same reason.

Otis Elevator Co.

v.

Secretary of Labor,

762 F.3d 116, 122 (D.C. Cir. 2014).

On the other hand, OSHA's understanding of the standard has not always been accepted. In

Reich

v.

General Motors Corp., Delco Chassis Div. (GMC Delco),

17 BNA OSHC 1217 (Nos. 91-2973, 91-3116, 91-3117, 1995);

aff'd

89 F.3d 313 (6th Cir. 1996), both OSHRC and the United States Court of Appeals for the Sixth Circuit rejected OSHA's interpretation. Instead they held that the lockout/tagout standard did not apply where a startup procedure for a machine provided a warning to a worker servicing it that it was about to start. In that case, workers were servicing machines that used an eight-to-twelve-step startup procedure, including time delays, and audible or visual warnings. The court and OSHRC held that, because these features would warn the servicing employees that the machines were about to start, the startup would not be “unexpected.” According to the Sixth Circuit, “the plain language of the lockout standard unambiguously renders the rule inapplicable where an employee is alerted or warned that the machine being serviced is about to activate.” 89 F.3d at 315.

OSHA believes that the

GMC Delco

decisions fundamentally misconstrue the “unexpected” language of the lockout/tagout standard by allowing employers to use warning and delay systems as alternatives to following the requirements of the standard. Warning devices are not as protective as a lockout/tagout program, and the standard does not allow them to be used as an alternative to a lockout/tagout program. Indeed, the exclusive use of warning devices subverts the intent of the standard by removing control over the hazardous energy from individual authorized employees and instead placing the burden on those exposed employees to become cognizant of and to recognize the warnings, so that they can attempt to escape danger zones before they are injured. In adopting the standard, OSHA considered this approach to be impractical and dangerous. Instead, OSHA intended to

protect employees effectively from all forms of hazardous energy by isolating machines from their energy sources during servicing and/or maintenance and providing the workers who were servicing them with control over the energy isolation devices (see CPL 02-00-147 at 3-3 & ch. 4).

In addition, by holding that work on a device that gives warning before startup does not fall within the standard, the

GMC Delco

decisions, in essence, require a case-by-case assessment of various warning schemes to determine the applicability of the standard. To enforce the standard consistent with those decisions, OSHA has provided its compliance officers with 11 different factors to evaluate to determine whether particular warning devices are adequate and reliable enough to allow all employees to escape all types of hazardous energy in all circumstances that may occur (see CPL 02-00-147 at 3-5 to 3-6). This creates a degree of uncertainty about the applicability of the standard for the regulated community that OSHA did not intend.

As a result of the

GMC Delco

decisions, OSHA is proposing to remove the term “unexpected” from the lockout/tagout standard to revert to its original understanding of the standard. The proposal is intended to make clear that the lockout/tagout standard covers all equipment servicing activities in which there are energization, startup, or stored energy hazards.

This proposal is consistent with the court's recognition that the rulemaking process provides OSHA with the opportunity to change the application of the lockout/tagout standard.

GMC Delco,

89 F.3d at 316. It will also make the standard consistent with OSHA's shipyard lockout/tagout standard, which is almost identical to the general industry standard except that it omits the word “unexpected” from the scope provision. 29 CFR 1915.89. The shipyard lockout/tagout proposal gave the same reasons for deleting the word as are provided here (72 FR 72452, 72496, December 20, 2007), and OSHA finalized the rule after failing to receive any comments addressing the issue. (76 FR 24576, 24704, May 2, 2011).

Removing the word “unexpected” will improve protection of workers under the standard, eliminate the confusion regarding applicability of the standard caused by the

GMC Delco

decisions, and make the lockout/tagout standard consistent with the lockout/tagout provisions in the General Working Conditions in Shipyard Employment standard.

2. Subpart Z of 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 is proposing a series of revisions to requirements addressing employee chest X-rays in the Agency's health standards. In particular, OSHA is proposing to remove the requirement in several of its standards that employers provide periodic chest X-rays to screen for lung cancer; to allow employers to use digital films and other reasonably-sized standard films for X-rays; and to update terminology and references to ILO guidelines included in its asbestos standards.

Removing Periodic Chest X-Ray Requirements for Lung-Cancer Screening

OSHA requires medical surveillance in its health standards to detect early indications of adverse health effects in exposed workers before symptoms occur, so that appropriate interventional measures can be taken. Several OSHA standards currently require periodic chest X-rays (CXR), also referred to as posterior-anterior CXR, radiographs, or roentgenograms (a term no longer used). When the Agency published these standards, routine screening for lung cancer with CXR was appropriate clinical practice. However, since then, large studies with many years of follow-up have not shown a benefit to CXR screening, either on lung cancer incidence or mortality. Therefore, OSHA is proposing to remove the requirement for periodic CXR in the following standards: §§ 1910.1018, Inorganic Arsenic; 1910.1029, Coke Oven Emissions; and 1910.1045, Acrylonitrile. OSHA is not proposing to remove the requirement for a baseline CXR in these, or any other, standards. OSHA is also not proposing to remove the CXR requirements in standards where it is used for purposes other than periodic screening for lung cancer. For example, the proposal does not affect periodic CXRs required by OSHA's standards to detect or monitor the progression of pneumoconiosis.

Similarly, OSHA is proposing to amend Appendix H of the asbestos standard, § 1910.1001.

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Appendix H provides non-mandatory guidelines for asbestos medical exposure, and OSHA proposes to include the text “Plural plaques and thickening may be observed on chest X-rays.” OSHA is retaining CXRs in the asbestos standard to continue screening for asbestosis, and the proposed text notes the changes related to asbestosis that can be seen on CXRs. The change thus explains the purpose of the CXR.

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OSHA is also proposing the same change for the parallel appendices in the Maritime and Construction Asbestos standards, 29 CFR 1915.1001 Appendix I and 1926.1101 Appendix I.

Section 6(b)(7) of the Occupational Safety and Health Act, 29 U.S.C. 655(b)(7), allows OSHA to modify medical examination requirements in existing standards when “warranted by experience, information, or medical or technological developments.” OSHA has used this authority on several occasions. For example, when contemporary evidence indicated that sputum cytology did not improve lung-cancer survival rates, OSHA removed the sputum-cytology-examination requirements from the Coke Oven and Inorganic Arsenic standards in the SIP-I rulemaking (63 FR 33450, 33458-59, June 18, 1998). In addition, OSHA also reduced CXR frequencies from semi-annual to annual for some workers exposed to inorganic arsenic and coke oven emissions in SIP-I. The Agency based this reduction on data available at the time indicating that semi-annual x-rays provided no additional protection, when compared to annual x-rays, in improving the detection of, and survival from, lung cancer for higher risk persons (63 FR 33459-60). This eliminated unnecessary radiation exposure for employees and reduced the burden on employers. OSHA retained the medical history and physical-examination requirements in these standards.

For the reasons discussed below, OSHA has made a preliminary determination that the current literature shows that there is no evidence of benefit, either in lung cancer incidence or mortality, from screening with CXR in the general population. The primary goal of population-based screening is to detect disease at an early stage when cure or control is possible, thereby decreasing the number of people who die from the disease (Black and Welch, 1997; U.S. Preventive Services Task Force (USPSTF), 2013; Mazzone, 2012).

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Several large-scale, randomized controlled trials have been conducted over the years to determine whether

screening with chest x-rays, with or without the addition of sputum cytology tests, was effective in reducing mortality from lung cancer. These studies are discussed below. The Mayo Lung Project compared participants in an “intervention” group, who were offered chest radiography and sputum cytology every four months, with those in a “control” group offered standard medical care. Participants were middle-aged and older men who were chronic heavy cigarette smokers and thus at high risk of developing lung cancer. After the initial prevalence screening, 9,211 male smokers aged 45 and older who completed the prevalence screening with negative results and who qualified for incidence rescreening were randomized to either of the two groups. The more screening-intensive intervention group was encouraged (and reminded) to undergo free chest x-rays and free sputum cytology tests every four months for six years. While the “controls” were offered standard medical care, they also were advised to undergo annual chest x-rays and sputum cytology tests, resulting in significant contamination of the control group by CXR performed off protocol. Follow-up ranged from one to five years, and averaged three years.

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Materials referenced are posted on

http://regulations.gov,

Docket No. OSHA-2012-0007, and are accessible at OSHA's Docket Office, U.S. Department of Labor, 200 Constitution Avenue NW., Room N2625, Washington, DC 20210; telephone (202) 693-2350. (OSHA's TTY number is (877) 889-5627.) OSHA Docket Office hours of operation are 8:15 a.m. to 4:45 p.m., E.T.

At the end of the follow-up (July 1, 1983), the Mayo Clinic study observed no difference in lung cancer mortality between the intervention and control groups, but observed an excess of 46 cases in the intervention group, a possible indication of over-diagnosis in lung cancer screening. The excess number of cases also could have resulted from short follow-up time (that is, additional cases may have been observed in the control group if the study lasted longer). In summary, this trial demonstrated significantly increased lung cancer detection, resectability, and survivorship after detection in the group offered screening every four months compared with the control group. However, there was no significant difference in lung cancer mortality rate between the two groups. Contamination of the control group, together with 25 percent non-compliance in the screened group, limited the statistical power of this trial. The authors concluded that “results do not justify recommending large-scale radiologic or cytologic screening for early lung cancer at this time (Fontana,

et al.,

1984; Fontana,

et al.,

1991).”

The term “over-diagnosis” refers to identifying through screening a disease that would otherwise remain undiagnosed during an individual's lifetime (

i.e.,

because symptoms do not present). Over-diagnosis is a serious potential risk of screening, as the evaluation and treatment of over-diagnosed cancer can lead to morbidity, and even to premature mortality (Black, 2000).

In order to assess whether over-diagnosis accompanies lung cancer CXR screening, Marcus

et al.

(2006) extended the follow-up of the same Mayo Clinic population studied by Fontana

et al.

for an additional 16 years using a randomized controlled trial with a stop-screen feature. A stop-screen study design (

i.e.,

one in which screening is terminated after a prespecified number of years but follow-up continues for ascertainment of cases of disease and deaths) provides the best setting in which to assess whether over-diagnosis accompanies screening (Marcus

et al.,

2006). If over-diagnosis does not occur, the cumulative number of cases in each group will be equal after screening stops and the number of cancers in the control group identified through symptoms catches up with those identified earlier through screening (Marcus

et al.,

2006).

At the start of the study in 1983, information on lung cancer status was available for 6,101 participants. From 1971 through the end of 1999, 585 participants in the more frequently screened group and 500 in the usual-care group were diagnosed with lung cancer. Because the number of lung cancers in the usual care group did not equalize with those in the more frequently screened group at the end of the study period, the study investigators concluded that “the persistence of excess cases in the intervention [group] after 16 years of additional follow-up provides continued support for over-diagnosis in lung cancer screening” (Marcus

et al.,

2006).

OSHA identified one study that included men who were younger than 45. A Czech study, Kubic and Polak (1986), enrolled 6,364 smokers aged 40 to 64 years. This study compared semi-annual screening using x-ray and sputum cytology to screening at three-year intervals, and to no screening. Although it found more earlier-stage lung cancers in both screened groups, this study also found no significant difference in mortality rates. In 1993, the Prostate, Lung, Colorectal, and Ovarian (PLCO) Randomized Trial examined the question whether screening would reduce mortality rates from PLCO cancers. In a randomized controlled study conducted in ten screening centers in the US, 154,901 participants aged 55 through 74 years were assigned either to the group that received annual CXR for three or four years, or to the “usual care” (no radiographic intervention) group; 51.6 percent of the participants were current or former smokers. All diagnosed cancers, deaths, and causes of death were ascertained through 13 years of follow-up or until December 31, 2009, whichever event occurred earlier (Oken

et al.,

2011). The study found no statistically significant differences in lung cancer mortality or incidence rates between the intervention and “usual care” groups, despite finding a higher proportion of early stage (potentially curable) lung cancers in the screened group (Hocking

et al.,

2010). Of particular note is the rate of false positives in the study; of 13,038 participants with at least one positive CXR, 12,730, or 97.6 percent, did not test positive for lung cancer. Furthermore, 121 participants without cancer underwent an invasive surgical procedure (Hocking

et al.,

2013).

An effective screening measure should detect a disease in its early stages before clinical signs and symptoms appear (Herman, 2006). Patients who are diagnosed while they are still asymptomatic tend to have better outcomes than those who are symptomatic (In,

et al.,

2008). It is well documented in the radiology literature that initial CXR misses 19-50 percent of lung cancers (Quekel, 1999). In the past decades, several technological innovations have shown improved sensitivity in detecting lung cancer. Several small studies have shown that newer techniques (

e.g.,

dual-energy subtraction radiology, electronic bone suppression, temporal subtraction) may result in fewer missed diagnoses of pulmonary nodules. However, no large-scale randomized or non-randomized studies are available that assess the sensitivity of these radiological techniques.

Baseline screening of general populations for unsuspected lung cancer with CXR yields only a small fraction—less than one percent—of lung cancer cases (Hocking

et al.,

2010; Kubik and Polak, 1986; Fontana

et al.,

1984). Currently, the majority (approximately 85 percent) of patients with lung cancer present for clinical evaluation with symptoms (Mazzone,

et al.,

2014); detection of lung cancer in the remaining (asymptomatic) patients frequently occurs when an x-ray or CT scan is done for another reason (Mazzone

et al.,

2014; PubMed Health).

Several authoritative sources of health-information do not recommend CXR for wide-scale screening. For example, the National Cancer Institute (NCI) in its online Lung Cancer Screening PDQ (Physician's Data Query) concluded, “Based on solid evidence, screening with chest x-ray and/or

sputum cytology does not reduce mortality from lung cancer in the general population or in ever-smokers.” The NCI PDQ goes on to discuss the harm associated with false-positive screenings: “Based on solid evidence, at least 95 percent of all positive chest x-ray screening exams (but not all) do not result in a lung cancer diagnosis. False-positive exams result in unnecessary invasive diagnostic procedures.” The NCI PDQ refers to the Oken (2011) and Marcus (2006) studies when estimating the magnitude of over-diagnosis at 6 percent to 17 percent. The Cochrane Collaboration, a non-profit group that reviews health-care literature for the purpose of making empirical recommendations, updated its original review article, “Screening for lung cancer,” in 2013. This latest review included nine trials (eight randomized controlled studies and one controlled trial) with a total of 453,965 subjects. The review includes many of the studies discussed here. The authors concluded:

The current evidence does not support screening for lung cancer with chest radiography or sputum cytology. Annual low-dose CT screening is associated with a reduction in lung cancer mortality in high-risk smokers but further data are required on the cost effectiveness of screening and the relative harms and benefits of screening across a range of different risk groups and settings.

(Manser

et al.,

2013).

Screening workers exposed to lung carcinogens is a complex issue. Current tools, particularly CXR, have not been shown to be effective in reducing mortality in high-risk smoking populations, and have not been studied in worker populations (Fontana, 1984; Oken, 2011; Marcus

et al.,

2011; Hocking

et al.,

2010). However, workers exposed to lung carcinogens are at a higher risk for lung cancer than the general population. OSHA conducts risk analyses as part of its regulatory requirements, and has determined that occupational exposure to each of these: Inorganic arsenic, coke oven emissions, and acrylonitrile, was found to be associated with a “significant risk” of lung cancer (§§ 1910.1018, Inorganic Arsenic; 1910.1029, Coke Oven Emissions; and 1910.1045, Acrylonitrile).

OSHA has also preliminarily determined that the existing evidence is insufficient to justify using alternative screening methods to CXR. While the National Institute for Occupational Safety and Health (NIOSH) is currently evaluating the applicability of Low-Dose Computed Tomographic (LDCT) as a screening tool for workers exposed to lung carcinogens, it may be years before this research can provide a recommendation on the efficacy of LDCT. Additionally, 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.

As noted earlier in this discussion, OSHA is proposing to remove the requirement to use periodic CXR as a screening tool for lung cancer from the following standards: §§ 1910.1018, Inorganic Arsenic; 1910.1029, Coke Oven Emissions; and 1910.1045, Acrylonitrile.

Although OSHA is proposing to remove periodic CXR requirements from the medical-surveillance sections of these three standards, the Agency emphasizes that the Access to Medical and Exposure Records standard (29 CFR 1910.1020) would still require employers to maintain all medical records, including records of CXRs previously administered. That is, this proposed rule would not relieve employers in general industry, maritime, and construction of the duty to maintain records of CXRs already administered under the requirements of §§ 1910.1018, 1910.1029, 1910.1045, 1915.1018, 1915.1045, 1926.1118, and 1926.1145

6

in accordance with § 1910.1020.

6

The Construction and Maritime Inorganic Arsenic and Acrylonitrile standards, §§ 1915.1018, 1915.1045, 1926.1118, and 1926.1145, merely reference the respective general industry standards (§§ 1910.1018 and 1910.1045), so OSHA is not proposing to revise them.

OSHA is not proposing to remove the initial, baseline CXR requirement in these three standards. The Agency recognizes that requiring initial, 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 health-care professionals evaluating those workers. For example, even with known limitations, CXR can serve to document the absence of disease. Baseline CXR also can be useful in preventing additional testing after detecting an abnormality at a future date. In this regard, the PLCO Screening Trial found that “evaluation stopped after comparison of the screening radiograph with a prior CXR in about one-third” of those participants presenting with an abnormal follow-up CXR (Hocking

et al.,

2013). When a worker receives a CXR prompted by symptoms, physical examination, or other indicator, and has an abnormality on that CXR, a baseline CXR from years before with the same lesion would reduce the need for additional evaluation (

e.g.,

CT scans, biopsy); such evaluations can be invasive, and lead to unnecessary irradiation for workers and additional costs for employers. However, workers receiving baseline CXR also may undergo invasive, potentially unnecessary work-ups and diagnostic testing for CXR-detectable lesions that may never progress to clinical significance. OSHA will continue to monitor the literature on baseline chest X-rays.

Updating Other Chest X-Ray Requirements

In recent years, improvements in medical technology permit screening with digital CXRs, also referred to as digital radiographs, in addition to traditional film-based CXRs. The medical community is rapidly adopting the technology, and both the International Labor Organization (ILO) and NIOSH recently published guidelines for digital radiographs (ILO, 2011; NIOSH, 2011).

OSHA is proposing to update the CXR requirements to allow the use of digital radiograph in the medical surveillance provisions of its Coke Oven Emissions, Acrylonitrile, and Inorganic Arsenic standards discussed above, and in its three asbestos standards and two cadmium standards. The latter standards are: §§ 1910.1001, Asbestos (General Industry); 1915.1001, Asbestos (Maritime); 1926.1101, Asbestos (Construction); 1910.1027, Cadmium (General Industry); and 1926.1127 Cadmium (Construction).

7

As noted previously, OSHA is proposing to add the option of digital radiography standards to its existing standards because digital radiography systems are rapidly replacing traditional analog film-based systems in medical facilities. Another Department of Labor Program, the Office of Workers' Compensation Programs, published a final rule allowing the submission of digital radiographs in connection with benefit claims, and set out quality standards for administering and interpreting digital radiographs. (See 79 FR 21606; April 17, 2014). OSHA's proposal will codify current Agency policy as stated in a Letter of Interpretation dated September 24, 2012 to Dr. Michael Hodgson, in which OSHA confirmed that it “will allow, but will not require, digital radiography in place of traditional chest roentgenograms for medical surveillance exams under the Asbestos Standards for

general industry, construction, and shipyards.”

7

The Maritime Cadmium standard, § 1915.1027, is a reference to the general industry standard (§ 1910.1027), so OSHA is not proposing to revise it.

Radiographic facilities and the physicians that are required by OSHA standards to classify CXR according to ILO's classification guidelines and that employ digital radiographs in their practice should follow the NIOSH Guidelines, “Application of Digital Radiography for the Detection and Classification of Pneumoconiosis,” or the most recent NIOSH guidance on using digital radiography to detect pneumoconiosis. In its current guidelines, NIOSH recommends that “only authorized ILO standard digital images should be used for classifying digital chest images for pneumoconiosis.” NIOSH does not recommend using film-based ILO reference radiographs for comparison with digital chest images or printed hard copies of the images. In this revision of the chest x-ray requirements, OSHA is also proposing to allow other reasonably-sized standard x-rays 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. In these standards, the phrase “A 14- by 17-inch film or digital posterior-anterior chest X-ray” (or similar) would be replaced by “A 14- by 17-inch or other reasonably-sized standard film or digital posterior-anterior chest X-ray.” This proposed change will affect the acrylonitrile standard (§ 1910.1045); the inorganic arsenic standard (§ 1910.1018); the coke oven standard (§ 1910.1029); and the asbestos standards (§§ 1910.1001, 1915.1001, and 1926.1101).

8

Updating this requirement ensures consistency across standards as well as conformance with current medical practice. This proposed change also would codify existing Agency policy outlined in a Letter of Interpretation (February 16, 1993 to David Lee Sirott) confirming that 16 inch by 17 inch X-rays are generally acceptable for the purpose of complying with OSHA standards.

8

And minor rewording to conform to the proposed language in the cadmium standards (1910.1027 and 1926.1127).

Proposed updates also include replacement of “roentgenogram” with “X-ray” to reflect current terminology and corrections to remove references to semi-annual exams for certain employees in Coke Ovens 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 addition, the proposal makes 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 specifically refers to a classification system as applying to CXR, while interpretation refers to the information translated by the physician to the employer. Finally, the proposed revisions include updating the version of the ILO Classification of Radiographs of Pneumoconioses to the 2011 version (from the 1980 version), and clarifying that classification must be accordance with the ILO classification system (rather than “a professionally accepted Classification system”) in Appendix E of each of the three asbestos standards.

Statement of Reasonable Availability

As noted above, OSHA is incorporating the ILO Classification of Radiographs of Pneumoconioses, Revised Edition 2011, by reference. OSHA believes that this classification document is reasonably available to interested parties. It is available for purchase from the International Labour Organization (ILO), 4 route des Morillons, CH-1211 Genève 22, Switzerland; telephone: +41 (0) 22 799 6111; fax: +41 (0) 22 798 8685; Web site:

http://www.ilo.org/.

In addition, it is available in the docket for this rulemaking and in OSHA's docket office for review. If OSHA ultimately finalizes this rule, the classification document will be maintained in OSHA's national and regional offices for review by the public.

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.

Bach, P.B., Mirkin, J.N., Oliver, T.K., Azzoli, C.G., Berry, D.A., Brawley, O.W., . . . and Detterbeck, F.C. (2012). Benefits and Harms of CT Screening for Lung Cancer: A Systematic Review.

JAMA,

307(22): 2418-2429.

Black, W.C. (2000). Overdiagnosis: An Underrecognized Cause of Confusion and Harm in Cancer Screening.

Journal of the National Cancer Institute,

Vol 92 (16): 1280

Fasola, G., Belvedere, O., Aita, M., Zanin, T., Follador, A., Cassetti, P.,

et al.

(2007). Low-Dose Computed Tomography Screening for Lung Cancer and Pleural Mesothelioma in an Asbestos-Exposed Population: Baseline Results of a Prospective, Nonrandomized Feasibility Trial—An Alpe-Adria Thoracic Oncology Multidisciplinary Group Study (ATOM 002).

The Oncologist,

12: 1215-1224.

Fontana, R.S., Sanderson, D.R., Taylor, W.F., Woolner, L.B., Miller, W.E., Muhm, J.R., and Uhlenhopp, M.A. (1984). Early Lung Cancer Detection: Results of the Initial (Prevalence) Radiologic and Cytologic Screening in the Mayo Clinic study.

Am. Rev. Resp. Dis.,

130(4): 561. Abstract only.

Fontana, R.S., Sanderson, D.R., Woolner, L.B., Taylor, W.F., Miller, W.E., Muhm, J.R., Bernatz, P.E., Payne, W.S, and Pairolero, P.C. and Bergstralh, E.J., (1991). Screening for Lung Cancer, A Critique of the Mayo Lung Project.

Cancer,

67(supplement): 1155-1164).

Herman, C. (2006). What Makes a Screening Exam “Good”?

AMA Virtual Mentor,

8(1):34-7.

Hocking, W.G., Hu, P., Oken, M.M., Winslow, S.D., Kvale, P.A., Prorok, P.C., Ragard, L.R.,

et al.

(2010). Lung Cancer Screening in the Randomized Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial.

J. Nat. Cancer Inst.,

102(10): 722-731.

Hocking, W.G., Tammemagi, M.C., Commins, J., Oken, M.M., Kvale, P.A., Hu, P., . . . and Prorok, P.C. (2013). Diagnostic Evaluation Following a Positive Lung Screening Chest Radiograph in the Prostate, Lung, Colorectal, Ovarian (PLCO) Cancer Screening Trial.

Lung Cancer.

82(2): 238.

In, K.H., Kwon, Y.S., Oh, I.J., Kim, K.S., Jung, M.H., Lee, K.H., Kim, S.Y., Ryu, J.S., Lee, S.Y., Jeong, E.T., Lee, S.Y., . . . Kim, Y.C. (2009). Lung cancer patients who are asymptomatic at diagnosis show favorable prognosis: a Korean Lung Cancer Registry Study.

Lung Cancer.

64(2): 232-7. Abstract only.

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

Kubik, A., and Polak, J. (1986). Lung Cancer Detection Results of a Randomized Prospective Study in Czechoslovakia.

Cancer,

57(12): 2427-2437.

Manser, R., Lethaby, A., Irving, L., Stone, C., Brynes, G., Abramson, M., and Campbell, D. (2013). Screening for Lung Cancer.

Cochrane Database Syst. Rev., The Cochrane Library, 6.

Marcus, P., Bergstralh, E.J., Zweig, M., Harris, A., Offord, K.P., and Fontana, R.S. (2006). Extended Lung Cancer Incidence Follow-up in the Mayo Lung Project and Overdiagnosis.

J. Nat. Cancer Inst.,

98(11).

Mazzone, P.J., Choi, H.K., and Ha, D. (2014) Lung Cancer. Cleveland Clinic Center for Continuing Education, The Disease Management Project, Chapter on Pulmonary Disease.

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

Annals Internal Med,

160 (5).

[NCI] National Cancer Institute (Last modified 2/2014). Screening for Lung Cancer With Chest X-Ray and/or Sputum Cytology. Retrieved from:

http://www.cancer.gov/cancertopics/pdq/screening/lung/HealthProfessional

on September 16, 2014.

Oken, M., Hocking, W., Kvale, P.,

Andriole, G., Buys, S., Church, T.,

et al.

(2011). Screening by Chest Radiograph and Lung Cancer Mortality: The Prostate, Lung, Colorectal, and Ovarian (PLCO) Randomized Trial.

JAMA,

306(17): 1865-1873.

PubMed Health, Retrieved 9/16/2014 from:

http://www.ncbi.nlm.nih.gov/

pubmedhealth/PMH0004529/

on September 16, 2014.

Quekel, L.G., Kessels, A.G., Goei, R, and van Engelshoven, J.M. (1999). Miss rate of lung cáncer on the chest radiograph in clinical practice.

Chest.

115(3):720-4.

Toyoda, Y., Nakayama, T., Kusunoki, Y., Iso, H., and Suzuki, T. (2008).

Brit. J. Cancer,

98: 1602-1607.

Screening for Lung Cancer, Topic Page (2013). U.S. Preventive Services Task Force. (2013). U.S. Preventive Services Task Force. Retrieved on September 16, 2014 from:

http://www.uspreventiveservicestaskforce.org/uspstf/uspslung.htm.

3. Subpart Z of 1910—Toxic and Hazardous Substances, Pulmonary-Function Testing Requirements for Cotton Dust in 29 CFR 1910.1043

Background

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, byssinosis is characterized by a continuum of effects (41 FR 56497, 56500-56501, December 28, 1976; 43 FR 27352-27354). Generally, workers who develop byssinosis first experience an acute stage (also called the reactor state), with mild and apparently reversible symptoms that occur on the first day of the work week, after one or more days away from the workplace. Symptoms include chest tightness, difficulty breathing, coughing, and possibly wheezing. Some of those workers also experience temporary acute declines in lung function over the course of a workshift as measured by pulmonary-function testing. As the disease progresses, workers may begin to experience symptoms on other days of the work week. Sometimes the disease progresses into a chronic, irreversible stage that involves permanent narrowing of bronchial tubes. Symptoms during the chronic stage are similar to symptoms observed with emphysema and chronic bronchitis, and include chronic cough with phlegm production and progressive shortness of breath. At this stage, impaired lung function associated with the disease is clearly detectable by pulmonary function testing. Byssinosis can lead to disability or death. Rates of progression depend on exposure levels and susceptibility of workers.

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)).

The preamble for the final Cotton Dust standard noted the poor accuracy and high variability of pulmonary function tests in the past, resulting from lack of uniform specifications for equipment calibration checks, test procedures, and personnel training (43 FR 27391). 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 is proposing to update the lung function testing requirements for the Cotton Dust Standard to make them consistent with current practices and technology.

Proposed 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. In the following discussion, references to generally accepted practices 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 (FEV1), by the total FVC to give the FEV1/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, and 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 discussion. Values are also compared to the employees' previous measurements.

Currently, § 1910.1043(h)(2)(iii) requires that health care providers conducting medical surveillance compare the employees' values to the predicted values in Appendix C of the standard. Appendix C currently contains predicted values derived from equations published by Knudson

et al.

(1976).

OSHA is proposing to revise this provision to specify use of the third National Health and Nutrition Examination Survey (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 will be incorporated by reference. Currently, NIOSH (CDC/NIOSH, 2003), ATS/ERS (Pellegrino

et al.,

2005), and ACOEM (Townsend, 2011) all recommend NHANES III as the most appropriate reference data set for assessing spirometry results for individuals in the U.S. population. The data set from NHANES III 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).

OSHA also proposes to make a correction to § 1910.1043, Appendix B-II, Section 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 would change the column's two sub-headers to

read as follows: “From 19_ or 20_” and “To 19_ or 20_”.

Statement of Reasonable Availability

As noted above, OSHA is incorporating the 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(1):179-187, January 1999). These values are also available to interested parties at

http://www.cdc.gov/niosh/topics/spirometry/nhanes.htm.

In addition, they are available at

www.regulations.gov

in the docket for this rulemaking and in OSHA's docket office for review. If OSHA ultimately finalizes this rule, the data set will be maintained in OSHA's national and regional offices for review by the public.

Section 1910.1043(h)(2)(iii) currently specifies that FEV1 and FVC predicted values be multiplied by 0.85 to obtain reference values for blacks 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 FEV1 be multiplied by a factor of 0.88. Therefore, OSHA is proposing use of a 0.88 correction factor to obtain Asian American reference values for the FVC and FEV1. Because race does not appear to affect FEV1/FVC (ratio), OSHA is not proposing 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).

OSHA's proposal to replace the Knudson values currently in Appendix C with the NHANES III data set would simplify interpretation of spirometry results by providing reference values for more race/ethnic groups; however, neither the NHANES III nor the proposed correction factor addresses every race/ethnic group. Therefore, OSHA is proposing text that indicates comparison to “appropriate” race/ethnicity values for groups not included in NHANES III. 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 category that best describes them. OSHA's guidance document 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 FEV1, 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 FEV1, FVC, and the FEV1/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 FEV1/vital capacity (VC) below the LLN. ACOEM (Townsend, 2011) and NIOSH (CDC/NIOSH, 2003) define borderline airway obstruction as an FEV1/FVC below the LLN, with an FEV1 between the LLN and the predicted value; they define airways obstruction as both FEV1/FVC and an FEV1 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 is proposing to update (h)(2)(iii) to require an evaluation of FEV1, FVC, and FEV1/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 described above. OSHA's proposal to evaluate the FEV1/FVC ratio in addition to FEV1 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 FEV1 values.

However, OSHA is also proposing to change 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 FEV1 is above or below 80 percent of the predicted value. OSHA is proposing that the basis for frequency of medical surveillance be whether the FEV1 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 is proposing to use the LLN to determine the frequency of lung-function testing.

Section 1910.1043, Appendix D, sets standards for spirometric measurements of pulmonary function. OSHA is basing the proposed changes to Appendix D on the most recent spirometry recommendations from ATS/ERS (Miller

et al.,

2005). Many of the proposed changes reflect advances in spirometry procedures or methods of interpretation.

9

Other proposed 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 proposed

changes would apply only to equipment purchased one year 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.

9

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 the proposed revision would change it from seven to eight liters. Current Appendix D(I)(e) specifies flow rates for flow-type spirometers, and the proposed revision would change it from 12 to 14 liters per second. These proposed 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 proposing to revise this language 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.

OSHA is proposing to add 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 proposing to revise paragraph D(I)(g) to indicate “If hand measurements will be made.” OSHA is proposing these changes because hand measurements are currently rarely used, and the values currently shown in the expiration curve are usually computer generated today.

Appendix D(I)(g) also requires the spirometer to display flow versus volume or volume versus time tracings. The proposed revision would require 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 proposing to update 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 proposing to update the first clause by specifying the currently recommended volume change of less than 25 milliliters for a 1-second interval (Miller et al, 2005) and is also proposing to remove 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. The proposed changes 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 proposing to update 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 proposal updates several of these requirements. The proposed revisions to Appendix D(I)(j), (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 proposed change is that while technicians cannot recalibrate many spirometer models in current use, they nevertheless must check all spirometers regularly when in use to ensure that the spirometers are operating within calibration limits,

i.e.,

that the spirometers are accurate (OSHA, 2013).

OSHA is proposing to delete the following text from Appendix D(I)(j) because it is ambiguous and provides no useful information: “. . . with respect to the FEV1 and FVC. This calibration of the FEV1 and FVC may be either directly or indirectly through volume and time base measurements.” OSHA also is proposing to update paragraph D(I)(j) to include the current ATS/ERS requirements for calibration-syringe accuracy and volume displacement (Miller

et al.,

2005). As noted above, OSHA is proposing to revise the term “calibration” to “calibration check.” Another proposed change to paragraph D(I)(j) 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 proposes to change the word “should” in D(I)(j) 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 that OSHA proposes to adopt are based on the 3 liter size of the syringe. OSHA seeks comment on this change to “shall.”

Current Appendix D(II)(b) provides that technicians should perform calibrations using a syringe or other source of at least two liters. The proposed change in the syringe volume to three liters is consistent with current practices. OSHA also is proposing to change the term “syringe or other volume source” to “syringe” for the reasons described above in the discussion of paragraph D(I)(j). Another proposed change to Appendix D(II)(b) would be 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 proposing calibration check procedures for flow-type and volume-type spirometers to determine whether a spirometer is recording 3 liters 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 also proposes to change the term “recalibration” in this provision to “calibration checks” for the reasons stated above in the discussion of paragraph D(I)(j). Finally, OSHA proposes to change “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 proposing to update this paragraph to have the patient perform at least three, but no more than eight, forced expirations during testing. This proposed 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 proposes that “subject” be changed to “patient” because “subject” implies someone in an experimental trial, while patient is the more appropriate term for someone undergoing screening at a medical facility, and “patient” is the term used most often in the standard. OSHA also is proposing to clarify 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 proposes to revise 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 proposed 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

until an obvious plateau in the volume-time curve occurs (Miller

et al.,

2005). 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 an obvious plateau in the volume-time curve (OSHA, 2013).

Appendix D(II)(a)(4) provides that the results are unacceptable when the worker coughs or closes the glottis during forced expiration. This proposed change clarifies 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 FEV1 (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).

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 FEV1 from a suboptimal effort (ATS, 1987). The proposed change would indicate that extrapolated volume must be less than 150 milliliters or 5 percent of the FVC, whichever is greater, to be unacceptable. It would update 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 proposing to include 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 would remove the word “three” because technicians can examine up to eight acceptable curves to select the two highest FEV1 and FVC values (Miller

et al.,

2005). OSHA is also proposing to change “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 is proposing to revise the maximum difference between the two largest FVC values and the two largest FEV1 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 proposed 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 FEV1 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 proposing editorial changes to make it clear that the difference between the two largest acceptable FVC values should not exceed 150 milliliters and the two largest acceptable FEV1 values should not exceed 150 milliliters.

The Agency discussed proposed changes to Appendix D(II)(b) above.

OSHA is proposing to remove Appendix D(III)(b). The paragraph refers to a NIOSH guideline that specifies an outdated evaluation criterion of FEV1/FVC ratio of 0.75 percent, and OSHA is unaware of an updated NIOSH cotton dust guideline that more appropriately compares the FEV1/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 proposed updates to paragraphs D(IV)(a) and (d) would 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 proposing to change the term “calibration” in paragraph D(IV)(b) to “calibration checks” for the reasons stated above in the discussion of paragraph D(I)(j). OSHA also proposes to change “subject” to “patient” in paragraph D(IV)(c) for the reason discussed above in the discussion of paragraph D(II)(a).

References

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

American Review of Respiratory Disease,

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.

http://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.

http://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. http://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,

http://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

. http://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.

Sanders, C. L., Yesupriya, A. J., and Curtin, L. R. (undated). Analysis of Population Structure and Stratification in NHANES III Self-Reported Race/Ethnicities.

http://www.cdc.gov/genomics/events/file/print/10year/08_pop_struct_ab.pdf.

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.

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

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

Existing requirements in the sanitation standard for Shipyard Employment, § 1915.88(j)(1) and (j)(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.” OSHA included this definition in the proposal for 29 CFR part 1915, subpart F, General Working Conditions in Shipyard Employment, on December 20, 2007 (72 FR 72452). In that NPRM, OSHA requested comment on the proposed vermin-control provisions, as well as examples of vermin that are present and the types of controls employers use to prevent the harborage of vermin in shipyard worksites.

Id.

at 72484. The Agency cited the hazards associated with exposure to insects, birds, and rodents in the preamble discussion, but did not mention any hazards associated with feral cats.

Id.

The Agency received two comments on these provisions. One commenter stated that vermin did not pose a serious hazard to workers and that OSHA should remove these provisions from the rulemaking (Ex. 197.1, Docket No. OSHA-S049-2006-0675). The other commenter explained that the number and types of vermin are greater than OSHA indicated in the proposed discussion, and that “[t]o `implement and maintain an effective control program' as required in this section would probably be very expensive, near impossible or even illegal” (Ex. 121.1, Docket No. OSHA-S049-2006-0675). Based on the general industry sanitation standard that applied to shipyard employment prior to the subpart F rulemaking, and these limited comments, the final standard adopted the proposed definition 76 FR 24576 (May 2, 2011). The final rule preamble also did not identify any hazards associated with feral cats.

Id.

at 24616.

Recently, stakeholders raised concerns about including feral cats in the definition of vermin. These stakeholders argue that while the possibility exists for feral cats to pose safety and health hazards for employees (

e.g.,

bites, scratches, fecal contamination), the threat is minor as the cats tend to avoid human contact. Further, these stakeholders expressed concern that including the term “feral cats” in the definition of vermin encourages cruel and unnecessary extermination. OSHA recognizes these concerns and, therefore, is proposing to remove the term “feral cats” from the definition in § 1915.80(b)(33). The revised provision would define the term “vermin” as “insects, birds, rodents and other animals that may create safety and health hazards for employees.” The Washington State Plan also removed the term “feral cats” from its definition of vermin, which is equivalent to OSHA's definition in § 1915.80(b)(33) (WAC 296-304-01001). The proposed revision also 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 other vermin. To the extent feral cats pose a safety or health hazard at any particular shipyard, OSHA would consider the cats to be “other animals” under the standard.

5. Subpart D of 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. Existing § 1926.50(f) requires 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 in 1979 when 911 emergency service was still a relatively new concept, and was available only in certain parts of the country.

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. However, carriers are not likely to complete the phase-in until 2019; consequently, the FCC established a procedure for exempting carriers from the location requirement. 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. The proposed revision to § 1926.50(f) updates the 911 service-posting requirements consistent with the current status of land-line and wireless-telephone technologies.

The proposed standard addresses the problem of locating callers, usually cell-phone callers, in remote areas that do not have automatic-location capability. In such areas, the proposed standard requires 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. OSHA notes that when ACCSH discussed this proposal, one member stated that he had seen a contractor provide latitude and longitude coordinates at a remote site on stickers given to employees. (ACCSH Aug. 23, 2013 transcript, p. 85.) 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:

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

The proposed revision also requires employers to ensure that the communication system they use to contact ambulance service is effective. Under existing § 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. The Agency is retaining the requirement to post telephone numbers of physicians, hospitals, or ambulances for worksites located in areas where 911 emergency service is not available.

6. Subpart D of 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. However, OSHA believes that several of these provisions, notably paragraph (a), paragraph (c), and Appendix A to § 1926.55, need clarification. In this regard, OSHA believes, first, that the use of the phrase “threshold limit values” and the reference to the American Conference of Governmental Industrial Hygienists (ACGIH), in both paragraph (a) and Appendix A, are confusing. Since these are OSHA standards, the correct terminology to express these limits is “permissible exposure limits,” and the proposed revision makes this revision. Moreover, while OSHA originally adopted these limits from ACGIH recommendations, the limits are OSHA, not ACGIH, requirements. Therefore, the proposed revision deletes the references to ACGIH.

Second, the phrase “shall be avoided” in paragraph (a) has an advisory, rather than a mandatory, connotation and, therefore, is not appropriate in regulatory text. OSHA is proposing to revise 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. Therefore, the proposed language deletes these words.

Fourth, Appendix A is not an appendix but an integral part of the standard. The proposal, therefore, would acknowledge this relationship by revising the heading to read, “Table A.”

Fifth, Appendix A (proposed Table 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. The proposed revision adds a footnote to the proposed table that clarifies the meaning of this designation.

Sixth, Appendix A (proposed Table A) has two footnotes designated by asterisks. However, there are no asterisks in the body of the appendix referencing these footnotes. The first footnote, consisting of a single asterisk, says, “The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit.” The second footnote, consisting of two asterisks, states, “As determined from breathing-zone air samples.” The proposed revision deletes these two footnotes, and moves the content of the footnotes to proposed paragraphs (a)(1) and (a)(2) of § 1926.55.

Finally, OSHA is proposing to correct the cross-references to OSHA's construction asbestos standard in paragraph (c) and in Appendix A (proposed Table A). The correct cross reference is: § 1926.1101.

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

To avoid unnecessary duplication, OSHA is proposing to replace 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. 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.

OSHA believes that it is unnecessary to reproduce the entire PSM Standard in 29 CFR part 1926 because construction employers rarely have a PSM program at their worksites. The PSM standard affects construction employers mainly through paragraph (h),

Contractors,

when they perform construction work at refineries or chemical-manufacturing plants; in these cases, the host employer generally will have a copy of the standard available. Should construction employers require a copy of the PSM Standard, they can obtain a copy readily at OSHA's Web page.

8. Subpart E of 1926—Personal Protective and Life Saving Equipment, Criteria for Personal Protective Equipment in 29 CFR 1926.95

Current § 1926.95(a) of the construction personal protective equipment (PPE) standard states that PPE “shall be provided, used, and maintained in a sanitary and reliable condition wherever it is necessary.” PPE must fit properly in order to provide adequate protection to employees. This can be a particular issue for small-stature construction workers, including some females, who may not be able to use standard-size PPE. Section 1926.95(c)'s requirement that PPE to be “of safe design” implicitly precludes the use of ill-fitting equipment. However, OSHA's construction standard does not contain an explicit requirement for PPE used in construction to fit each affected employee, like the general industry PPE standard does (see 29 CFR 1910.132(d)(1)(iii)).

Several commenters responding to the request for information for this rulemaking, including the AFL-CIO and the International Safety Equipment Association, recommended that the Agency revise its construction PPE standards to ensure that PPE fits all construction employees (Exs. OSHA-2012-0007-0012 and -0018).

Revising § 1926.95(c) to require employers to select PPE that properly fits each employee will clarify the construction PPE requirements on this point and make them consistent with general industry PPE requirements. The Agency believes that providing clear and explicit language on this point will help ensure employers provide employees with properly fitting PPE, thereby adequately protecting employees exposed to hazards requiring PPE. The proposed language, therefore, merely clarifies, and makes explicit, the requirement that all PPE used in construction fit properly.

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

OSHA is proposing to revise the minimum breaking-strength requirement for lifelines in the Safety belts, lifelines, and lanyards standard, § 1926.104(c), to 5,000 pounds. This proposed revision will bring § 1926.104(c) into conformity with the breaking-strength requirements for lanyards and vertical lifelines in the Fall protection systems criteria and practices (“Fall Protection”) standard at § 1926.502(d)(9). The Agency concludes that making identical specifications for the same equipment will avoid confusion and, thereby, improve compliance.

The breaking strength of a lifeline is the maximum load that it can carry without failing or breaking. Under existing § 1926.104(c), the minimum breaking-strength requirement is 5,400 pounds. 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 revised requirement of 5,000 pounds adopted in the final Fall Protection standard and proposed now for § 1926.104(c) 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.

This proposed revision also is consistent with the most recent ANSI/ASSE standards Z359.1 2007 and A10.32.

10. Subpart G of 1926—Signs, Signals, and Barricades

The provisions regarding accident prevention signs, signals, and barricades in 29 CFR 1926.200(g), 201 and 202, subpart G (Signs, Signals, and Barricades), contain requirements for employers' use of accident prevention signs, tags, signaling and barricades. These provisions require that traffic control signs and devices used for the protection of workers, barricades used for the protection of workers, and signaling by flaggers and the use of flaggers, including warning garments worn by flaggers, comply with the mandatory provisions of either of two versions of Part VI of the MUCTD. Employers may comply with Part VI of the 1988 Edition, Revision 3, September 3, 1993, MUTCD (“1988 Edition”) or the Millennium Edition, December 2000 MUTCD (“Millennium Edition”).

Several commenters to the SIP-IV Request for Information (77 FR 72781), including the AFL-CIO (OSHA-2012-0007-0012), the Laborers' Health and Safety Fund of North America (OSHA-2012-0007-0011), and the American Road and Transportation Builders Association (OSHA-2012-0007-0025), asked OSHA to update subpart G because the Department of Transportation (DOT) updated the MUTCD in 2009. These revisions aimed to expedite traffic, promote uniformity, improve safety, and incorporate technology advances in traffic control device application (74 FR 66730). In addition, DOT issued two revisions to the MUTCD in 2012 (77 FR 28455 and 77 FR 28460).

OSHA is proposing revisions to Subpart G, including an update to the references to the MUTCD to the November 4, 2009 MUTCD (“2009 Edition”), including Revision 1 dated May 2012 and Revision 2 dated May 2012. Updating the reference to the 2009 Edition MUTCD will eliminate 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.

Statement of Reasonable Availability

OSHA believes that the Manual on Uniform Traffic Control Devices is reasonably available to interested parties. It is available from the Federal Highway Administration, United States Department of Transportation, 1200 New Jersey Ave. SE., Washington, DC 20590; telephone: 202-366-4000; Web site:

http://www.fhwa.dot.gov/.

In addition, it is available in the docket for this rulemaking and in OSHA's docket office for review. If OSHA ultimately finalizes this rule, the standards will be maintained in OSHA's national and regional offices for review by the public.

DOT requires that traffic control signs or devices conform to the 2009 Edition

(see 23 CFR 655.601 to .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 1988 Edition and the Millennium Edition MUTCDs 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 MUTCDs 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 concluded that the more recently published manual will provide greater employee safety benefits than the older versions. The 2009 revisions to the MUTCD largely make the document more accessible and account 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. Often, 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.

• There is 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.

• 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

regulations.gov

in Docket No. OSHA-2012-0007).

Section 1926.200(g)—Traffic signs.

Current paragraph (g)(1) of § 1926.200 states, “[c]onstruction areas shall be posted with legible traffic control signs at points of hazard.” Accordingly, current paragraph (g)(1) does not explicitly require protection by traffic control devices. However, existing 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. Additionally, current enforcement procedures allow OSHA to cite an employer for a violation under paragraph (g)(1) when the employer exposes an employee to a hazard resulting from the lack of protective devices at points of hazard when the devices (

i.e.,

channelization devices and warning devices) would essentially serve as signs. (CPL 02-01-054, Paragraph XIII.F.2).

The proposed revision explicitly requires that employers use traffic control devices at points of hazard. Accordingly, OSHA is proposing to revise paragraph (g)(1) to require employers to use both signs and devices at points of hazard. While paragraph (g)(2) would still cover the misuse of signs and devices, the proposal would revise this paragraph too. Proposed paragraph 200(g)(2) would clarify that it covers the design and use of traffic-control devices, and would add a list of those devices: Signs, signals, markings, barricades, and other devices. Consistent with these revisions, OSHA would also revise the headings of § 1926.200 and paragraph (g) by adding the term “devices” to these headings. The Agency would retain the requirement that signs be legible. These changes would clarify the requirements for signs and devices.

Section 1926.201—Signaling.

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

Section 1926.202—Barricades.

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

Section 1926.203—Definitions applicable to this subpart.

OSHA is proposing to delete this section because the MUTCD defines or describes most of the words defined in this section (

e.g.,

barricade, signs, signals). If OSHA retained this section, it would need to update these definitions to conform to the MUTCD. To the extent that other provisions of subpart G use the defined words but do not reference the MUTCD, OSHA believes that providing definitions for these words is unnecessary because the meanings of the words are either obvious or defined clearly in applicable consensus standards or in other OSHA standards;

for example, an adequate description of a “tag” is in § 1926.200(h).

In summary, OSHA is proposing to amend the safety and health regulations for construction to adopt and incorporate the 2009 Edition of the MUTCD and clarify the regulatory text. The revisions would 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 would amend the regulatory text of paragraphs (g)(1) and (g)(2) of § 1926.200 to eliminate confusion regarding OSHA's interpretation of the current text. The proposal deletes § 1926.202 because it duplicates the requirements in the proposed revisions to § 1926.200(g) and § 1926.203 because the proposed revisions make this section unnecessary.

11. 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 in large buildings under construction because employers store large, heavy quantities of building materials in these structures to accommodate construction staging and schedules. However, requiring employers to post safe load limits is unnecessary in single-family home construction because employers do not use these structures for storing heavy materials that could endanger employees working at lower levels should the floor collapse. Therefore, OSHA is proposing to exclude detached, single-family residences and townhouses from the posting requirement.

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

12. Subpart P of 1926—Excavations, Specific Excavation Requirements in 29 CFR 1926.651

Paragraphs (j)(1) and (j)(2) of § 1926.651 specify requirements for employers to protect employees from (1) loose rock or soil in excavations, and (2) excavated or other materials or equipment that could fall or roll into an excavation. Similar provisions were part of OSHA's subpart P Excavation standard originally issued under the Construction Safety Act in 1971 as 29 CFR 1518.651(h) and (i) (36 FR 7340, 7389, April 17, 1971), and OSHA retained them when it revised the standard in 1989 (54 FR 45894, Oct. 31, 1989). The original 1971 standard placed the burden on employers to ensure employees' safety from loose rock and soil, and excavated or other materials, in or around excavations (36 FR 7340, 7389). The 1989 revision added to the paragraphs (j)(1) and (j)(2) the phrase “that could pose a hazard” when referring to loose rock or soil and excavated or other materials or equipment (54 FR 45894, 45924-45925).

A number of decisions by administrative law judges of the Occupational Safety and Health Review Commission (OSHRC) have interpreted the added phrase in the standard as placing the burden on OSHA to establish that loose rock or soil or excavated or other material or equipment poses a hazard to employees before it can establish a violation of §§ 1926.651(j)(1) and (j)(2). (See,

e.g., Black Construction Corp.,

19 BNA OSHC 1043 (2000) (ALJ) ((j)(1));

Schaer Development of Central Florida, Inc.,

No. 11-0371, 2011 WL 3394942 (OSHRC ALJ June 2, 2011) ((j)(2))). These decisions are contrary to most of OSHA's standards, which presume that a hazard exists unless the employer can demonstrate otherwise (see,

e.g., Austin Bridge Co.,

7 BNA OSHC 1761 (1979)). Moreover, the preamble to the 1989 revision does not indicate that OSHA intended to shift the burden when it revised the 1971 provisions, but only to clarify the language of the provisions (54 FR 45894, 45924). Thus, OSHA is proposing to remove the phrase “that could pose a hazard” from § 1926.651(j)(1) and (j)(2). This revision would clarify, as originally intended, employers must protect their employees from loose rock or soil and excavated or other materials or equipment, and that OSHA does not have the burden of demonstrating the existence of a hazard. Therefore, the standards presume a hazard unless an employer complied with the protections required by §§ 1926.651(j)(1) and (j)(2).

Section 1926.651(j)(1) applies to loose rock or soil that can fall from the face of the excavation. The preamble to the 1989 revision states that this provision does not apply to all excavations, only those excavations with loose rock or soil of “sufficient volume [to] endanger an employee” (54 FR 45894, 45924). It is the employer's duty to assess whether (1) the rock or soil is loose and (2) of sufficient volume to potentially endanger or injure employees in the excavation. The proposed revision would remove the phrase “that could pose a hazard,” but would keep the language limiting this provision to loose rock or soil. As noted in the previous paragraph, removing the language “that could pose a hazard” from the provision would preserve the duty of employers to protect workers from the hazard, while relieving OSHA of the initial burden of demonstrating that a hazard exists. OSHA also is proposing to remove the language “by falling or rolling from an” from the provision as that language is unnecessary to describe the hazard; however, OSHA is proposing to retain the term “excavation face” in the provision to clarify the location of the hazard.

Section 1926.651(j)(2) applies to excavated materials (“spoil piles”) or other materials or equipment that are on the surface near the excavation. Employers must keep these piles, and other materials or equipment, at least two feet from the edge of the excavation, or prevent them from moving by using retaining devices. Excavated soil is loose and may present a hazard to workers in an excavation. As explained in the preamble to the 1989 revision:

The intent of this requirement is to protect employees from materials, equipment, and spoil piles which might fall into excavations. Obviously, materials such as excavated soil and stored construction supplies can superimpose loads on the walls of an excavation. Such loads can be the cause of cave-ins and must be considered when determining what protection is necessary to safeguard employees.

(54 FR 45894, 45925).

The proposed revision would remove the phrase “that could pose a hazard by falling or rolling into excavations,” but would retain the language “excavated or other materials or equipment,” from the first sentence in paragraph (j)(2). The proposed language would keep the remaining language in the paragraph, including the two-foot rule, and would remove from OSHA the burden of demonstrating that a hazard exists, while retaining the employers' duty to protect employees from the hazards of excavated or other materials or

equipment placed less than 2 feet from the edge of the excavation.

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

Existing regulatory language in § 1926.800(k)(10)(ii) requires 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 that demonstrate 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;

10

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 55411). In 2001, MSHA issued 30 CFR 57.5067, which permits operators 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). The Agency proposes to update the regulatory language in § 1926.800(k)(10)(ii) to cross-reference these updated provisions.

10

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

OSHA's existing regulatory language in § 1926.800(i)(2) requires that mobile diesel powered equipment used in “gassy operations” underground be approved by MSHA in accordance with the provisions of 30 CFR part 36, or that the employer demonstrate that the equipment is “fully equivalent” to MSHA-approved equipment. MSHA has also updated part 36. However, the reference in § 1926.800(i)(2) remains correct, and OSHA does not need to change the language to ensure employers are following MSHA's updated requirements.

Under 30 CFR 57.5067, all engines used in underground 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. To use equipment with non-permissible engines in non-gassy operations, the employer must ensure it meets the requirements listed in 30 CFR 75.1909, 75.1910, and 75.1911 for other machine features. If the employer wishes to use equipment with permissible engines, in gassy operations, it must ensure the equipment meets the requirements listed in 30 CFR part 36 for other machine features.

When MSHA revoked 30 CFR part 32 in 1996, it directed state and federal agencies that reference 30 CFR part 32 to 30 CFR part 7, subpart E and 30 CFR 75.1909 and 75.1910 (61 FR 55416). Accordingly, the proposal substitutes references to those sections for the reference to part 32. OSHA has also proposed including 30 CFR 75.1911(a)-(i) in the cross-reference because § 75.1909 requires certain equipment to have fire suppression systems in accordance with § 75.1911. To maintain the scope of 29 CFR 800(k)(10)(ii), OSHA is not proposing to incorporate § 75.1911 paragraphs (j) and (k) (regarding fire suppression systems on diesel-powered equipment), which are training and recordkeeping requirements that were not contained in the original 30 CFR part 32. In addition, OSHA is not proposing to incorporate § 75.1911(l), which addresses the interaction of that section with other MSHA requirements not relevant here. Thus, OSHA has not included paragraphs (j)-(l) in the cross reference.

If adopted, these changes will allow employers to use diesel-powered engines on mobile equipment in underground construction that meets current MSHA requirements.

The existing OSHA standard allows employers to use non-MSHA approved engines if they can demonstrate that they are fully equivalent. The existing standard and OSHA give no guidance how employers can make such a demonstration. OSHA believes that the allowance for engines that meet or exceed EPA requirements in MSHA Table 57.067-1 is a much more effective and simple way to allow the use of non-MSHA approved engines. OSHA solicits comments on whether employers do make such demonstrations and whether the use of EPA requirements will better effectuate a safe and healthful workplace.

For other machine features, the proposal requires that equipment with non-approved engines meeting the applicable EPA requirements must also meet the requirements of 30 CFR 75.1909, 75.1910, and 75.1911(a)-(i) for non-permissible engines used in “other than gassy” operations. Because these requirements list features, the only way for an employer to demonstrate equivalency is to show that the equipment has the required features, rendering the “fully equivalent” clause unnecessary as to “other machine features.” Therefore, because OSHA believes that the function of the current “fully equivalent” clause is captured by the updates to the referenced MSHA regulations, the Agency has not retained the language in the proposal.

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 has therefore preliminarily concluded that all applicable new equipment currently available for in the market meets the proposed 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 and are complaint 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). OSHA solicits comment on whether there are engines in use that meet the existing standard but will not meet the requirements of current MSHA standard and, if so, whether continued use of such equipment presents a serious safety or health hazard. OSHA also seeks comment on whether this proposed grandfathering is workable.

14. Subpart S in 1926—Underground Construction, Caissons, Cofferdams and Compressed Air, Compressed Air in 29 CFR 1926.803

OSHA is proposing to revise subpart S—Underground Construction, Caissons, Cofferdams, and Compressed Air by replacing the decompression tables currently found in Appendix A to subpart S with the 1992 French Air and Oxygen decompression tables. OSHA is also requesting comment on whether the following decompression tables should also be permitted as substitutes for the existing tables in Appendix A: The Edel-Kindwall (NIOSH) tables, the Blackpool (British) tables, and the German Standard Decompression tables. OSHA has preliminarily concluded that the French tables provide safer decompression practices than the OSHA decompression tables currently found in Appendix A to subpart S. OSHA proposes to revise § 1926.803(f)(1) to require employers to follow the 1992

French Air and Oxygen decompression tables to decompress employees exposed to compressed air environments. OSHA proposes to adopt the French tables with an incorporation by reference, while deleting Appendix A.

The current decompression tables in OSHA's subpart S standard were developed by Washington state. According to a NIOSH Request for Information (77 FR 74193), the Washington state Decompression Tables were used by several states prior to 1971, when OSHA adopted them as the federal requirement in Appendix A to subpart S. These tables were adopted under section 6(a) of the OSH Act, which permitted the Agency, for a two-year period, to adopt then-current consensus standards as its own without notice and comment rulemaking. The tables in Appendix A prescribe decompression by reducing the pressure that workers are exposed to at intervals in accordance with the schedule in the tables. The current tables address exposures ranging from half an hour to over eight hours, with only one decompression schedule for exposures of greater than eight hours. Subpart S prohibits employee exposures to compressed air environments of greater than 50 pounds per square inch (p.s.i) (§ 1926.803(e)(5)).

Employers in the tunneling construction industry have requested variances from the underground construction standards in subpart S from federal OSHA as well as states with State Plans. The requests seek a variance to use decompression tables other than those found in Appendix A to subpart S as well as other provisions in the underground standards. In their requests, employers in the industry assert that using other decompression tables is safer than using OSHA's current decompression tables. Also of note, many of the tunneling projects have working pressures ahead of the drill head higher than 50 p.s.i.—so none of the tables in Appendix A would be appropriate or safe. The variance requests suggest that using tables that provide for decompression from environments under pressure greater than 50 p.s.i. and provide staged decompression (stopping workers at set depths and pressures to prevent decompression illness (DCI)), with an enriched oxygen atmosphere, provide greater protection to employees from DCI. The decompression tables that were developed after the 1970s use elevated levels of oxygen to aid in the decompression process.

The ineffectiveness of the current OSHA tables for preventing DCI is discussed in a 1986 study by Gregory J. Downs and Edel P. Kindwall. During a tunneling project in Milwaukee where pressures ranged from 28 psig to 43 psig and the current OSHA tables were used for decompression, 33 percent of tunneling workers examined experienced aseptic necrosis, a form of DCI also known as dysbaric osteonecrosis that causes portions of the bone tissue to die.

11

The study explains that parts of the current OSHA tables “poorly facilitates total nitrogen elimination,” resulting in instances of aseptic necrosis for a substantial number of workers decompressed in accordance with the tables at the Milwaukee tunneling project.

12

Downs and Kindwall concluded that the OSHA tables are “considered inadequate in efficiently eliminating nitrogen from the body, and allow bone disease at pressures in excess of 36.5 psig.”

13

Kindwall mentioned in a subsequent study that there were inconsistencies in the OSHA tables. For example, the decompression times at 26 and 44 psig are the same for six and eight hour exposures. He believes that this is the result of a mistake made during the transcription of the tables.

14

11

Downs GJ, Kindwall EP (1986) “Aseptic necrosis in caisson workers: A new set of decompression tables,” p. 570.

12

Id.

13

Id.

14

Kindwall, EP (1997). Compressed air tunneling and caisson work decompression procedures: Development, problems, and solutions. Undersea and Hyperbaric Medicine, 24(4), p. 342.

On May 23, 2014 OSHA granted a permanent variance to an underground construction contractor allowing, among other things, the employer to use the 1992 French decompression tables (79 FR 29809). In granting this variance, OSHA found that if the employer followed the requirements of the variance, including the French decompression tables, the working conditions for employees would be at least as safe as following OSHA's standard (79 FR 29816). OSHA granted similar variances for other projects on March 27, 2015 (80 FR 16440), and August 20, 2015 (80 FR 50652). On July 27, 2015, OSHA published a

Federal Register

notice seeking comment on an employer's variance request to use the 1992 French decompression tables for all future tunneling projects it performs, subject to certain conditions (80 FR 44386). (Note that “at least as safe” is the main criterion OSHA follows to evaluate variance requests.)

On December 15, 2011, the Seattle Tunnel and Tail Team gave a presentation to the Advisory Committee on Construction Safety and Health (ACCSH), titled

Tunnel Advances

(OSHA-2011-0124-0066). The presentation discussed how technology and work practices have changed in the underground construction industry, particularly since the promulgation of subpart S. They illustrated this point by showing the number of variances that were needed to complete underground construction projects safely, as many of the requirements of subpart S have become outdated. One of the common variance requests asks to use decompression tables other than the current OSHA decompression tables.

1992 French Air and Oxygen Decompression Tables

The 1992 French decompression tables replaced an older series of tables from 1974. The French Ministry of Labor revised the earlier tables when a number of cases of DCI occurred during an underground construction project.

15

OSHA conducted a review of the scientific literature on DCI during work under higher air pressure to determine whether use of the decompression methods in the 1992 French Decompression Tables was more effective or safer than following the tables currently in the standard. Based on this review, OSHA has preliminarily concluded that decompression recoveries performed with these tables will result in a fewer cases of DCI than the decompression tables specified by the current standard.

15

Le Pechon, JC, Barre, P, Baudi, JP, Ollivier, F (1992). Compressed Air Work—French Tables 1992 Operational Results. p. 285.

The review conducted by OSHA found several studies supporting the determination that the 1992 French Decompression Tables result in a lower rate of DCI than the decompression tables specified by the standard. For example, H. L. Andersen studied the occurrence of DCI at maximum hyperbaric pressures ranging from 4 p.s.i.g. to 43 p.s.i.g. during construction of the Great Belt Tunnel in Denmark in 1992-1996.

16

This project used the 1992 French Decompression Tables to decompress the workers during part of the construction. Anderson observed 6 DCI cases out of 7,220 decompression events, or a frequency of 0.0008 (0.08 percent). The DCI incidence in the study by Andersen is substantially less than the DCI incidence reported by Eric Kindwall for the decompression tables specified in Appendix A of the current standard. In his study, Kindwall reported 60 treated cases of DCI among

4,168 exposures between 19 and 31 p.s.i.g., resulting in a DCI incidence of 1.44 percent using the current OSHA tables.

17

OSHA found no studies in which the DCI incidence reported for the 1992 French Decompression Tables were higher than the DCI incidence reported for the OSHA decompression tables. The results of these studies show that the French tables do a better job of minimizing the significant risks of decompression illness than the current OSHA tables.

16

Anderson HL (2002). Decompression sickness during construction of the Great Belt tunnel, Denmark. Undersea and Hyperbaric Medicine, 29(3), pp. 172-188.

17

Kindwall, EP (1997). Compressed air tunneling and caisson work decompression procedures: Development, problems, and solutions. Undersea and Hyperbaric Medicine, 24(4), pp. 337-345.

During decompressions under the May 23, 2014 variance to Tully/OHL USA Joint Venture, which allowed use of the French decompression tables during hyperbaric operations, the Tully/OHL reported no instances of DCI using the French tables.

18

Likewise, during decompressions under the variance to Traylor/Skanska/Jay Dee Joint Venture, which also allowed use of the French decompression tables, Traylor/Skanska/Jay Dee reported no instances of DCI. (Traylor 2015). The French tables also address decompression at greater pressures than 50 p.s.i and for durations longer than eight hours.

18

Email from Luis Alonso to Stefan Weisz, RE: Tully Variance End of Project Effectiveness Evaulation Report—Reminder, January 21, 2015.

State-Plan states have also granted variances to entities asking to use the 1992 French Air and Oxygen Decompression tables. On June 25, 2007, Washington state granted a permanent variance to VCGP/Parsons RCI/Frontier-Kemper, JV that allowed, among other things, the use of the 1992 French Air and Oxygen decompression tables. Based on its research, the state of Washington determined that “decompression using oxygen is much more effective in purging the body of residual nitrogen,” concluding that the French tables were at least as effective as the decompression tables in their standard (OSHA-2012-0036-0009). Similarly, Nevada (OSHA-2012-0036-0006) and Oregon (OSHA-2012-0036-0007) approved variance requests to use the French tables.

Based on a review of available evidence, the experience of State-Plan states (discussed above) that granted variances (Nevada, Oregon, and Washington) for hyperbaric exposures occurring during similar subaqueous tunnel-construction work, and OSHA's previously issued variance allowing use the French Decompression Tables, OSHA is proposing to replace the tables in Appendix A with the 1992 French Decompression Tables, which will be incorporated by reference into § 1926.803(f)(1).

Other Tables

In 2003, Valerie Flook published “

A comparison of oxygen decompression tables for use in compressed air work,

” a Health and Safety Executive study comparing several oxygen decompression tables, including the British, French, German, and Edel-Kindwall tables. The study “was commissioned to compare a number of tables used for oxygen decompression from compressed air work in order to identify the safest set of tables. . . .” The study used a mathematical model to predict the maximum gas volume in bubbles in the central venous blood at the end of decompression using each set of tables. The report noted that the model used had been verified by comparison to actual nitrogen gas bubble counts (measured using Doppler technology) after various compression decompression trials in both animal and human subjects. As explained by NIOSH, nitrogen gas bubbles in the body are a precursor to DCI.

19

19

CDC—Decompression Sickness and Tunnel Workers,

http://www.cdc.gov/niosh/topics/decompression/default.html.

The Flook study concluded that “[t]he range of gas volumes predicted for most exposures is small and it is unlikely that the different [decompression] profiles could be distinguished. . . .” (Flook, 2003, 34). The British, French, Edel-Kindwall, and German tables, among others, all achieved a quantity of nitrogen gas bubbles that was within the same range. Similar to the French tables, the British and German tables also address decompression at greater pressures than 50 p.s.i. and for durations longer than eight hours, while the Edel-Kindwall tables do not. OSHA is seeking comment on whether the Edel-Kindwall, British, and/or German tables should be included as options in the OSHA standard. OSHA also seeks any scientific information beyond the Flook study demonstrating the effectiveness of these tables in preventing DCI. If OSHA were to add any of these tables (British, Edel-Kindwall, and/or German) to § 1926.803 in addition to the French tables, then employers would be able choose any of the added tables to decompress employees. OSHA provides more information about each below.

Edel-Kindwall Tables

OSHA asks for comment on whether the Edel-Kindwall decompression tables should (also) be included as a replacement for the tables in Appendix A of subpart S. The Edel-Kindwall tables were developed in response to several tunneling workers experiencing DCI using the current OSHA decompression tables. Between 1971 and 1973 during a tunneling project in Milwaukee, Wisconsin, workers experienced aseptic necrosis, when using the current OSHA decompression tables. This incident prompted NIOSH to determine if alternate decompression tables could be developed.

20

20

CDC—Decompression Sickness and Tunnel Workers,

http://www.cdc.gov/niosh/topics/decompression/history.html.

NIOSH awarded a contract to Eric Kindwall to develop staged decompression tables. The tables, later known as the Edel-Kindwall decompression tables, included the use of oxygen because it shortened decompression time considerably, from over 10 hours to less than four hours. A 1986 study by Kindwall and Gregory J. Downs tested the effectiveness of the Edel-Kindwall tables to eliminate nitrogen from the body and reduce instances of DCI. Six human subjects were compressed for this experiment. While compressed, each subject simulated work conditions for four hours. After performing many activities to establish baseline information for each subject, they were decompressed in accordance with the OSHA or Edel-Kindwall air and oxygen tables. The comparison of the OSHA tables and the Edel-Kindwall air table ability to eliminate nitrogen from the body resulted in “no statistical difference” between the two tables. The comparison of the OSHA tables and the Edel-Kindwall oxygen table showed that the Edel-Kindwall oxygen table was “more efficient in eliminating nitrogen” than the OSHA tables. Kindwall and Downs concluded that their “data is definitive enough to for immediate acceptance of this table for use by the construction industry.” Although Kindwall and Downs expressed some concerns regarding the cost of equipment, oxygen toxicity and flammability, they did not believe these potential concerns outweighed the “shorter decompression times and reduced morbidity” offered by the Edel-Kindwall tables.

21

21

Downs GJ, Kindwall EP “Aseptic necrosis in caisson workers: A new set of decompression tables,” 1986.

The Edel-Kindwall tables have been approved as part of variance requests in some State Plan states. In its December 15, 2011 presentation, the Seattle Tunnel and Tail Team presented permanent variances—one from Oregon in 2004 and another from Washington in 2007—that approved the use of the Edel-Kindwall tables for underground

construction projects within those states (OSHA-2011-0124-0066).

German Decompression Tables

OSHA asks for comment on whether to (also) include the German decompression tables as a replacement for the tables in Appendix A of subpart S. These decompression tables were developed by Dr. Max Hahn.

22

These tables were approved for use in Oregon, along with the French tables, in 2006 (OSHA-2012-0036-0007). The information from the Flook study discussed above resulted in the German decompression tables being approved by the Health and Safety Executive for use in the United Kingdom, “the first time non-UK tables had been used on a UK contract.”

23

22

Huggins, Karl E “The Dynamics of Decompression Workbook”, 1992.

23

Lamont, DR, Flook, V “A Comparison of Oxygen Decompression Tables for Use in Hyperbaric Tunnelling”.

British Blackpool Tables

OSHA asks for comment on whether the British Blackpool decompression tables should (also) be included as a replacement for the tables in Appendix A of subpart S. The Blackpool decompression tables were published in 1973 with air as the breathing gas for decompression.

24

The Blackpool decompression tables are included in the United Kingdom's Health and Safety Executive's “A Guide to Compressed Air Work 1996,” The Guide updated the “Work in Compressed Air Special Regulations 1958.”

25

In 2001, oxygen decompression became mandatory in the United Kingdom, using a modified Blackpool table that required “oxygen breathing from 0.6 bar downwards.”

26

A year later, the Health and Safety Executive reprinted “A Guide to Compressed Air Work 1996” to reflect the change in policy. The modified Blackpool Tables were compared to other oxygen decompression tables in the Flook study discussed above.

24

Lamont, DR, Flook, V “A Comparison of Oxygen Decompression Tables for Use in Hyperbaric Tunnelling”.

25

A guide to the Work In Compressed Air Regulations 1996, Health and Safety Executive.

26

Lamont, DR, Flook, V “A Comparison of Oxygen Decompression Tables for Use in Hyperbaric Tunnelling”.

Insofar as the Agency can find, underground projects which incorporate new tunneling technology have not followed OSHA's existing decompression tables, but have followed more recently developed tables. In each case, federal OSHA or a State Plan state has been persuaded by the available research and studies on the matter that the newer decompression methods better protect underground workers. (The states have either granted variances (discussed above) or promulgated a new standard (California

27

)). Many of these tunneling projects also require work in atmospheres above the 50 p.s.i. limit in OSHA's construction subpart S, as current tunneling technology, when there are gaseous or wet underground conditions particularly, require higher pressures. (OSHA is not proposing to change the 50 p.s.i. limit in the SIP-IV rulemaking.)

27

California incorporates the Navy Diving Manual by reference. Because these tables are specifically for diving, conversions are necessary to use the tables in a non-diving application. See

http://www.dir.ca.gov/title8/6085.html.

For this reason, OSHA is not proposing to add, or seeking comment on, the Navy Diving Manual.

SIP-IV Request for Information

Given the evidence suggesting that other decompression tables are at least as safe and in many cases safer than OSHA's current decompression tables, OSHA asked for comment on this topic in its Standards Improvement Project—Phase IV, Request for Information (77 FR 72781; Dec. 6, 2012). OSHA received comments from various groups requesting that OSHA update or revise its decompression tables (OSHA-2012-0007-0011, -0016, -0017). All of the commenters stated that OSHA's current decompression tables were outdated and did not address the hazard of DCI as well as more recently developed decompression tables. NIOSH argues that updating the decompression tables in Appendix A will shorten the time needed for decompression and reduce the instances of decompression sickness (OSHA-2012-0007-0017). NIOSH recommended that OSHA take the following steps when updating its decompression tables: Require staged decompression, allow 100 percent oxygen use during decompression, vary the decompression schedule based on exposure time, and allow for greater pressures in underground construction projects. NIOSH also recommended that OSHA adopt the Edel-Kindwall tables. The Laborers' Health and Safety Fund of North America recommended that OSHA adopt the French and Tri-mix

28

tables, with a certifying physician and variances from OSHA above 8 bars (116 p.s.i.) of pressure (OSHA-2012-0007-0011).

28

Tri-mix is a mixture of three breathing gases: Oxygen, nitrogen, and helium. The mixture of the gases is usually proprietary.

OSHA must set safety standards that provide a high degree of worker protection (

Int'l Union, UAW

v.

OSHA,

37 F.3d 665,669 (D.C. Cir. 1994); 58 FR 16612, 16615 (Mar. 30, 1993)). Such standards must also be feasible and cost-effective. Based on the evidence discussed above, OSHA preliminarily determines that the best available evidence shows that the decompression tables in Appendix A to subpart S are not highly protective and that the French tables are more protective of worker health. OSHA is seeking comment on whether the Edel-Kindwall, British, and German tables should be included as options in the OSHA standard. In addition, OSHA requests comment on NIOSH's statement that staged decompression will shorten the time needed for decompression.

Therefore, OSHA proposes to remove the decompression tables found in Appendix A of Subpart S and replace them with the 1992 French Air and Oxygen decompression tables. The French tables have been used most often in the U.S., and the Agency has collected more information on their safety. Regarding the request for comment on other identified tables, OSHA also asks whether it would be less confusing and easier for the tunneling industry to use one set of tables, rather than include more alternatives in the OSHA standard?

The tables will be posted in the docket of this proposal for commenters to view.

Alternative Regulatory Structure

OSHA seeks comment on an alternative regulatory structure for regulating which decompression tables will be used to decompress workers from a compressed air environment. Under this structure, in addition to removing its current decompression tables, OSHA would also revise § 1926.803(f) to allow employers to use any decompression table that a qualified person determines will protect workers from instances of DCI on the project. The table used would have to meet accepted industry practices for prevent DCI in workers.

As discussed earlier, OSHA adopted the Washington state decompression tables into its regulations under section 6(a) of the Occupational Safety and Health Act. Although used by several states prior to their adoption, few, if any, studies regarding the effectiveness of the Washington state decompression tables were done prior to their adoption by OSHA. Instances of DCI using the current OSHA tables led NIOSH to support research that resulted in the creation of the Edel-Kindwall tables. Since then, several other tables have been developed that when used result in a lower incidence of DCI.

OSHA has granted variance requests from members of the underground construction industry asking, among other things, to use decompression tables that they believe are at least as effective as the current OSHA tables found in Appendix A of subpart S. On May 23, 2014, OSHA granted the variance request of Tully/OHL USA Joint Venture (79 FR 29809). Tully/OHL USA requested to use the 1992 French decompression tables, which permit both air and oxygen decompression. OSHA granted a variance to Traylor/Skanska/Jay Dee Joint Venture in which they also requested to use the 1992 French decompression tables, as well as the proprietary Trimix tables, in their variance application (80 FR 16440).

29

OSHA also granted a permanent variance to Impreglio Healy Parsons Joint Venture on August 20, 2015 (80 FR 50652). Their variance application also requested to use the 1992 French decompression tables (OSHA-2014-0011-0001). Several occupational safety and health programs have approved of various decompression tables for underground construction work. In the Seattle Tunnel and Tail Team's presentation to ACCSH, they included variances from Washington that approved the use of the 1992 French decompression tables, Trimix tables, and modified NIOSH (Edel-Kindwall) tables (OSHA-2011-0124-0066). The presentation also included a variance from Oregon that approved the use of the DCIEM Oxygen Decompression tables, also known as the Canadian Navy Tables, the 1992 French Decompression Tables, and the NIOSH (Edel-Kindwall) Oxygen Decompression tables (OSHA-2011-0124-0066). In their comment to the Request for Information, the Laborer's health and Safety Fund of North America recommended OSHA adopt the French tables, but listed four other decompression tables—the Edel-Kindwall tables, the U.S. Navy Tables (Revision 6), the Canadian Navy Tables (1992), and the Trimix tables (for pressures over 4.8 bar)—that had been approved by variance in several states. (OSHA-2012-0007-0011). Furthermore, the Flook study suggests that many of the oxygen decompression tables provide virtually the same protection from DCI.

29

Although Traylor/Skanska/Jay Dee Joint Venture requested the use of Trimix tables in their variance application for the Blue Plains Tunneling (BPT) project, they later explained to OSHA that “[a]t the Blue Plains Tunnel, Traylor will not experience hyperbaric pressures greater than 3.6 bar. Therefore we do not plan on using trimix at the BPT project.” OSHA-2012-0035-0013.

Given the numerous decompression tables that employers requests to use in variance applications, it appears that the industry does not believe there is one table that is applicable for all underground construction projects where workers may need to be decompressed. OSHA believes using a performance standard rather than specifying which table an employer must use may allow employers greater flexibility in providing safe decompression for their workers. OSHA requests comment on this regulatory approach.

Statement of Reasonable Availability

OSHA believes that the 1992 French Decompression Tables included in this proposal are reasonably available to interested parties. The tables are published in the Official Journal of the French Republic, titled “Travaux en milieu hyperbare, measures particulières de prevention” (Work in hyperbaric environment, specific prevention measures). J. O. Rep. Franç. Brochure n° 1636, June 1992. The tables are available for purchase from the French government at

http://www.journal-officiel.gouv.fr/.

In addition, it is available in the docket for this rulemaking and in OSHA's docket office for review. If OSHA ultimately finalizes this rule, the tables will be maintained in OSHA's national and regional offices for review by the public.

Subpart S—Underground Construction, Caissons, Cofferdams and Compressed Air also has several provisions that limit the quantities of oxygen that may be taken below ground and kept there. OSHA asks for comment on providing an exception to those requirements for purposes of maintaining oxygen on hand for decompression purposes, which would be necessary in a final rule as the updated tables discussed above require the use of oxygen.

15. Subpart W of 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 is proposing to amend the existing standards 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 is also proposing to remove irrelevant text from § 1926.1000.

The original source standards for the current subpart W requirements are the Society of Automotive Engineers Standards (“SAE”) J320a-1971, J394-1971, J395-1971, J396-1971, J334a-1970, J167-1970, J168-1970, and J397-1969. The American National Standards Institute and SAE subsequently canceled these standards. To design and develop new equipment the industry now uses the most recent International Organization for Standardization (“ISO”) standards: ISO 3471-2008; ISO 5700-2013; and ISO 27850-2013. Though the names of the construction equipment covered by the consensus standards have changed over time, OSHA believes that all the equipment listed in current § 1926.1001(a) is covered by one of those ISO standards. A comment from a representative of Caterpillar, Inc. stated that the SAE standards have either been cancelled or superseded by new ISO standards (OSHA-2012-0007-0009). OSHA reviewed the relevant standards and believes that the standards identified in the proposed revisions reflect the current design and development of ROPS for equipment covered by subpart W. OSHA preliminarily concludes that using the proposed ISO standards will be as protective as using the current OSHA standards. Therefore, OSHA is proposing that, for new equipment manufactured after the effective date of the revised standard, the performance measures for testing ROPS meet the ISO standards. This proposed incorporation by reference will eliminate over 20 pages of text and diagrams in the CFR.

OSHA proposes to rename § 1926.1000 as “Scope” because this more accurately describes what follows in this section. Proposed paragraph (a) lists the types of equipment currently covered by subpart W. It also adds compactors and rubber-tired skid-steer equipment manufactured after the effective date of the final rule, which existing § 1926.1000(a)(2) anticipates as a possible expansion of the scope. The most recent ISO standards apply to compactors and skid-steer loaders as well as the equipment included in the current standard, and based on interviews with several manufacturers OSHA preliminarily concludes that all compactors and skid steer loaders currently produced meet those requirements. Proposed paragraph (b) states which standards apply to equipment manufactured before the publication of a final rule. Proposed paragraph (c) states which standards

apply to equipment manufactured after the publication of a final rule. Paragraphs (d) through (f) remain unchanged in the proposal, but OSHA solicits comment on whether paragraphs (d), “

Remounting,”

(e), “

Labeling,”

and (f), “

Machines meeting certain existing governmental requirements”

are necessary or are obsolete (due to adoption of modern consensus standards) and should be deleted.

Currently, § 1926.1000(c) limits the application of the requirements of §§ 1926.1001 and 1926.1002 to equipment manufactured after July 1, 1969. The proposal eliminates this limitation because it is OHSA's understanding that there are not any pieces of covered equipment in operation today that are more than 45 years old and do not meet the SAE standards. OSHA seeks comment on whether this is so, and any data on the types and numbers of pre-1969, non-SAE compliant equipment currently in use.

Current § 1926.1001 provides ROPS requirements for rubber-tired self-propelled scrapers, rubber-tired front end loaders, rubber-tired dozers, crawler tractors, crawler-type loaders, and motor graders. The proposed rule deletes the current ROPS specifications for this equipment, and replaces it with a requirement that covered equipment manufactured before the effective date of the final rule comply with SAE J397-1969—Critical Zone—Characteristics and Dimensions for Operators of Construction and Industrial Machinery, SAE 320a-1970—Minimum Performance Criteria for Roll-Over Protective Structure for Rubber-Tired, Self-Propelled Scrapers, SAE J394-1970—Minimum Performance Criteria for Roll-Over Protective Structures for Rubber-Tired Front End Loaders and Rubber-Tired Dozers, SAE J395-1970—Minium Performance Criteria for Roll-Over Protective Structure for Crawler Tractors and Crawler-Type Loaders, and SAE J396-1970—Minimum Performance Criteria for Roll-Over Protective Structure for Motor Graders, as applicable. The proposal requires equipment manufactured after the effective date of the final rule (including compactors and rubber-tired skid steer equipment) to meet the requirements of ISO 3471-2008, Earth-moving machinery—Roll-over protective structures—Laboratory tests and performance requirements. This standard contains specifications for ROPS to protect employees. Because, as noted above, OSHA believes that covered equipment is already being manufactured to the requirements of ISO 3471-2008, the proposal provides the option for equipment manufactured before the effective date of the final rule to comply with the ISO standard rather than the SAE standards.

Current § 1926.1002 provides ROPS requirements for wheel-type agricultural equipment and industrial tractors used in construction. The proposed rule deletes the current ROPS specifications for this equipment, and replaces it with a requirement that covered equipment manufactured before the effective date of the final rule comply with SAE J168-1970-

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