* Training on all of the SOPs developed as part of the WICP that are applicable to the worker's duties;
   * An explanation of the use and limitations of engineering, administrative and work practice controls; and
   * Information on the types, proper use, limitations, location, handling, decontamination, removal, and disposal of PPE.
The annual refresher training program, as presented in the regulatory framework, would be required to address at least the following elements:
   * Information on the types, proper use, limitations, location, handling, decontamination, removal, and disposal of PPE.
   * All of the SOPs developed as part of the WICP that are applicable to the worker's duties, and;
   * Information on vaccination(s) that will be made available to the worker in the year of training.

OSHA preliminarily estimates that it would take a total of 30 hours for the individual who would be training exposed workers to develop training materials.  The initial training is preliminarily estimated to take either two or three hours, depending on the job tasks of the workers, and the annual refresher training is also preliminarily estimated to take two or three hours, again depending on the job tasks of the workers.
Per the Draft Report on Current Compliance, and as shown in Table VI-10, OSHA preliminarily estimates that laboratories provide 86 percent of workers with appropriate training and that hospitals provide 84 percent of workers with appropriate training.  Moreover, laboratories provide an estimated 79 percent of workers with annual refresher training, and hospitals provide an estimated 75 percent of workers with annual refresher training.  Home healthcare and long term care and nursing homes also are estimated to have relatively high levels of compliance with training requirements.  Home healthcare agencies provide an estimated 68 percent of workers with appropriate training, and long term care and nursing home establishments provide an estimated 72 percent of workers with appropriate training.  Further, home healthcare agencies provide an estimated 50 percent of workers with annual refresher training, and long term care and nursing home establishments provide an estimated 54 percent of workers with annual refresher training.  Employers in "other occupational settings," including morgues and mortuaries and waste handling and laundry services, provide only an estimated 23 percent of workers with appropriate training, and physicians' offices provide only an estimated 25 percent of workers with appropriate training; baseline compliance rates for annual refresher training are estimated to be only 14 percent and 18 percent in those settings, respectively.  OSHA welcomes any feedback the SERs may have to offer on these preliminary estimates of current compliance.
   5.          Recordkeeping
Per the regulatory framework, OSHA would require employers to maintain the following records:  medical records generated in conjunction with medical screening and surveillance (including evaluations, examinations, testing, follow-up, and vaccinations); exposure incident records; and WICP review records.  In addition, OSHA's Respiratory Protection Standard (29 CFR 1910.134), discussed earlier in this section of the SER Background document, requires the employer to maintain records regarding medical evaluations, fit testing, and the respiratory protection program (29 CFR 1910.134(m).  OSHA anticipates that a final rule as outlined in the regulatory framework would have costs associated with all of these recordkeeping provisions.
OSHA preliminarily concludes that there would be no additional costs associated with a provision of the regulatory framework that would require maintenance of WICP review records.  The costs associated with reviewing and updating the WICP were addressed previously in this section of the SER Background Document.  Likewise, the Agency preliminarily estimates that there would not be any additional recordkeeping costs associated with a respiratory protection program, above the cost of the time to develop the program, which costs OSHA also addressed previously in this section of the SER Background Document.
OSHA preliminarily estimates that it would take 25 minutes to create and file records for each medical screening performed in conjunction with the medical screening and surveillance provisions of the regulatory framework.  This estimate is based on estimates of 10 minutes to create a file for each new employee, as estimated in OSHA's 2010 ICR for bloodborne pathogens (OSHA, 2010), and 15 minutes for recordkeeping associated with initial medical screenings, as estimated in OSHA's PEA for the Proposed Rule on Silica (OSHA, 2013a).  In addition, based on the 2011 ICR for OSHA's Respiratory Protection standard, the Agency preliminarily estimates that any medical evaluation, done for the purposes of evaluating a worker's ability to use a respirator, or as a result of a worker having a medical evaluation per the regulatory framework, would generate a medical record, which would take five minutes for a record-keeper to maintain (OSHA, 2011).  For vaccinations, the time requirement is estimated to be 15 minutes per employee for a record-keeper to create and file a vaccination record (OSHA, 1991), or five minutes for the record-keeper to create and file a signed declination form.  OSHA also preliminarily estimates that an additional five minutes per year, per employee will be necessary to update vaccination records in settings where workers would be required to get annual vaccines, such as the flu vaccine.  For respirator fit-testing, the Respiratory Protection ICR suggests a recordkeeping unit cost of five minutes annually per fit test (OSHA, 2011).
OSHA preliminarily estimates that employers would spend 15 minutes generating and filing exposure incident records in accordance with a rule as outlined in the regulatory framework.  The Agency estimated costs related to the investigation of exposure incidents earlier in this section of the SER Background Document, and estimates that the information potentially required in the exposure incident records would be collected during those investigations.  The additional 15 minutes accounted for here is the time OSHA estimates it would take for an employer to transfer the information to a formal record and to file that record.  OSHA notes that, per the regulatory framework, OSHA would require that each exposure incident record include a description of any post-exposure evaluations and follow-ups that were performed, the results of those evaluations, and the dates on which they occurred.  As noted above, OSHA preliminarily estimates that it would take a record-keeper five minutes to maintain records related to medical evaluations, and any post-exposure evaluations and follow-ups that result from an exposure incident and that take place after the exposure incident record is initially generated will, likewise, take an additional five minutes to document (over the 15 minutes that OSHA preliminarily estimates would be needed to generate and file the exposure incident record).
OSHA requests comments on the time required to create, file, and maintain records that would be required under a rule as outlined in the regulatory framework.

C.	Summary of Preliminary Estimates of Unit Costs
Table VI-9, below, presents all of OSHA's preliminary estimates of the potential unit costs of compliance that would be associated with provisions of a rule as outlined in regulatory framework for infectious diseases.  OSHA discussed how these unit costs were derived throughout this section of the SER Background Document.  To the extent SERs seek clarification about the entries in Table VI-9, they should refer to this discussion.

D.	Preliminary Estimates of Baseline Compliance Rates

Table VI-10, below, presents OSHA's preliminary estimates of current compliance with selected provisions of the regulatory framework for infectious diseases.  OSHA described how it generated these preliminary estimates in the Introduction to this section of the SER Background Document.

Section VII.  Description of Any Duplicative, Overlapping, or Conflicting Rules

The Regulatory Flexibility Act (RFA) requires that the Agency's "initial regulatory flexibility analysis . . . identif[y], to the extent practicable, [] all relevant Federal rules which may duplicate, overlap or conflict with the proposed rule."  5 U.S.C. 603(b)(5).  (Separately, the OSH Act does not apply to "working conditions" of workers with respect to which another federal agency has "exercise[d] statutory authority to prescribe or enforce standards or regulations affecting occupational safety or health."  29 U.S.C. 653(b)(1).)

OSHA has not yet developed a proposed rule addressing occupational exposure to infectious diseases.  However, as discussed in prior sections of the SER Background Document, OSHA has developed a regulatory framework showing its preliminary thinking on what a proposed rule would encompass.  OSHA has identified several federal rules and guidelines that address infection control.  Below, the Agency discusses whether these rules and guidelines would duplicate, overlap, or conflict with a rule as outlined in the regulatory framework.

The first set of federal rules or guidelines that OSHA identified are guidelines promulgated by CDC/HICPAC (CDC, 1998).  The CDC/HICPAC guidelines include provisions for:  identification and isolation of infectious cases; immunizations for vaccine-preventable diseases; standard and transmission-based precautions; training; PPE; management of healthcare workers' risk of exposure to infected persons, including post-exposure prophylaxis; and work restrictions for exposed or infected healthcare personnel (Bolyard et al., 1998; see also, e.g., Siegel et al., 2007).

While the CDC/HICPAC guidelines present recommended practices for reducing the risk of infectious disease transmission to patients and workers, the guidelines are non-mandatory.  Such non-mandatory guidelines do not constitute rules that would duplicate, overlap, or conflict with a rule as outlined in the regulatory framework.  Cf. Ensign-Bickford Co. v. OSHRC, 717 F.2d 1419, 1421 (D.C. Cir. 1983) (agency regulates working conditions only if it "implements [a] regulatory apparatus"); Marshall v. Northwest Orient Airlines, Inc., 574 F.2d 119 (2d Cir 1978) ("sister agency must actually be exercising a power to regulate safety conditions").

There also would be no conflict between a rule as outlined in the regulatory framework and the CDC/HICPAC guidelines because a rule as outlined in the regulatory framework would be performance-based and is, in fact, intended to assure that employers adopt and implement infection control practices consistent with the CDC/HICPAC guidelines.  Such a rule would require employers having workers covered by the rule to develop, implement, and update SOPs that are consistent with recognized and generally accepted good infection control practices relevant to their work setting.  To determine whether SOPs are consistent with recognized and generally accepted good infection control practices, the employer would have to consider applicable regulations, such as state and local regulations, and current guidelines, such as the CDC/HICPAC guidelines.  Moreover, in the absence of such regulations and guidelines, the employer would need to consider current guidance issued by professional organizations and accrediting bodies.  As such, a rule as outlined in the regulatory framework would allow employers to incorporate appropriate CDC/HICPAC guidelines into their infection control programs. Therefore, OSHA concludes that the CDC/HICPAC guidelines would not duplicate, overlap, or conflict with such a rule.

The second set of federal rules or guidelines that OSHA identified are Centers for Medicare and Medicaid Services (CMS) regulations that condition a provider's participation in Medicare or Medicaid on the provider's implementation of an infection control program.  CMS interpretive guidelines say that, to meet this condition, providers should ensure that their infection control programs conform to nationally-recognized infection control practices and guidelines, such as the CDC/HICPAC guidelines.  CMS regulations do not cover providers that do not accept or collect payment through Medicare or Medicaid.  However, they do cover health care providers that accept or collect payment through Medicare or Medicaid (which requires a certification, that involves an inspection covering infection control procedures as they affect patient safety in order to participate), including hospitals, nursing homes, home health care (of kinds covered by Medicare), hospices and ambulatory care facilities providing hospital-like services, such as ambulatory surgical centers and specialty clinics.  The CMS regulations do not cover employers engaged in some other covered tasks that take place in facilities where direct patient care is not also provided, such as those that occur in research or production laboratories and death care facilities

A rule as outlined in the regulatory framework would not conflict with the CMS regulations.  To the contrary, the joint effect of the CMS regulations and a new OSHA rule would improve the quality and implementation of infection control programs in a manner that the CMS regulations cannot do, and have not done, alone. The Joint Commission (a CMS-approved accreditation organization) recognizes the need to improve the quality and implementation of infection control programs.  (See for example http://www.centerfortransforminghealthcare.org/assets/4/6/hand_hygiene_storyboard.pdf ). Moreover, other evidence OSHA has examined thus far (some of which is discussed in Section III, above) indicates that, notwithstanding the CMS regulations, many employers receiving Medicare and Medicaid funding are not fully conforming to nationally recognized infection control practices and guidelines.

OSHA has, at its disposal, enforcement mechanisms that CMS does not have.  For example, OSHA can respond to complaints and conduct random unannounced inspections.  On the other hand, the CMS regulations establish the terms of a contractual or quasi-contractual agreement between CMS and a provider.  A provider agrees to implement an infection control program in exchange for the right to participate in Medicare and Medicaid.  Cf. Ensign-Bickford Co., 717 F.2d at 1421 n.3 (noting that the repercussions of violating a contractual agreement "stand[] in sharp contrast to the civil and criminal penalties provided for in the [OSH] Act").  Compliance with the CMS regulations is generally validated through periodic accreditation surveys of the employer's facility by CMS-approved accreditation organizations, including the Joint Commission, state survey agencies, and other organizations that specialize in accrediting various types of healthcare facilities (e.g., Accreditation Association for Ambulatory Health Care (AAAHC)).

The joint effect of OSHA and CMS enforcement can reasonably be expected to result in better compliance than either one alone.  This conclusion is borne out by the joint effect of CMS's enforcement of its infection control regulations alongside OSHA's enforcement of its existing Bloodborne Pathogens standard  -  a regime that has been in place for over twenty years.  As noted in Section III, the Bloodborne Pathogens standard, which has existed alongside the CMS regulations since its promulgation, led to significant declines in bloodborne diseases among healthcare workers.

A rule as outlined in the regulatory framework would also not conflict with the CMS regulations because such a rule, like the CMS regulations, would allow employers to incorporate into their infection control programs appropriate nationally-recognized infection control practices and guidelines, such as the CDC/HICPAC guidelines.  Thus, such a rule would complement the CMS regulations and would be likely to improve overall compliance with infection control practices.

The third set of federal rules or guidelines that OSHA identified are a group of identical regulations for research that require the protection of human subjects and that were jointly promulgated by fifteen federal agencies, including HHS, the Department of Veterans Affairs, and the Environmental Protection Agency (EPA).  56 FR 28003 (June 18, 1991).  Pursuant to those regulations, when research involving human subjects is conducted, supported, or otherwise subject to regulation by a federal department or agency, an Institutional Review Board (IRB) must review and approve the research and determine that the risks to the subjects are minimized.

Unlike a rule as outlined in the regulatory framework, the regulations requiring the protection of human subjects do not necessarily require the protection of workers.  That an individual protocol reviewed and approved by an IRB may address worker protection does not mean the regulations themselves address working conditions.  Due to these factors, OSHA concludes that the regulations requiring the protection of human subjects would not duplicate, overlap, or conflict with a rule as outlined in the regulatory framework.

A rule as outlined in the regulatory framework would also not conflict with the regulations requiring the protection of human subjects because such a rule would permit employers conducting research on infection control practices to consider research protocols that are not consistent with recognized and generally accepted good infection control practices, provided those protocols have been approved by an IRB and adequately address worker protection as a component of the overall protection of the human subjects.  A rule as outlined in the regulatory framework would therefore complement the regulations requiring the protection of human subjects.

The fourth set of federal rules or guidelines that OSHA identified are Department of Transportation (DOT) regulations that address the safe transport of hazardous materials, including infectious agents.  These requirements contain provisions regulating, among other things, the containerization, packaging, marking, labeling, and placarding of these materials.

The fifth set of federal rules or guidelines that OSHA identified are EPA regulations, promulgated pursuant to the Clean Air Act (42 U.S.C. 7401 et seq.), governing emissions from hospital/medical/infectious waste incinerators.  The regulations require that the training of incinerator operators cover, among other things, "work safety procedures."

The sixth set of federal rules or guidelines that OSHA identified are EPA guidelines contained in its Guide for Infectious Waste Management.  These guidelines address primarily decontamination, but also address several other areas, including packaging, storage, and transport of infectious waste, as well as disposal of treated waste (EPA, 1986).

OSHA concludes that there may be some duplication or overlap between the DOT regulations, and the EPA regulations and guidelines, and a rule as outlined in the regulatory framework.  However, OSHA believes that, unlike these regulations and guidelines, an OSHA rule would protect workers in a comprehensive manner.  A rule as outlined in the regulatory framework would address, not only the training of workers, or the decontamination, transport, containerization, packaging, marking, labeling, and placarding of infectious agents, but myriad other means of protecting workers against the hazards associated with exposure to infectious agents (such as, the provision in the regulatory framework addressing the development and implementation of a written worker infection control plan designed to prevent or minimize the transmission of infectious agents to each worker).  The DOT regulations, and the EPA regulations and guidelines, also would not conflict with a rule as outlined in the regulatory framework because, again, such a rule would be performance-based.

The final set of federal rules or guidelines that OSHA identified are existing OSHA standards, including: the Bloodborne Pathogens standard (29 CFR 1910.1030); the Respiratory Protection standard (29 CFR 1910.134); the Personal Protective Equipment standard (29 CFR 1910.132); and the Specifications for Accident Prevention Signs and Tags standard (29 CFR 1910.145).  All of these existing standards would remain in place unless otherwise stated in a rule as outlined in the regulatory framework.

The Agency believes that the Bloodborne Pathogens standard would not be duplicative, overlapping, or conflicting with a rule as outlined in the regulatory framework for the following reason: a rule as outlined in the regulatory framework addresses occupational exposure to infectious agents transmitted by contact, droplet and airborne routes other than occupational exposure as defined by the Bloodborne Pathogens standard.  OSHA notes that an employer's implementation of a rule as outlined in the regulatory framework may be streamlined in light of the infection control procedures already required by the Bloodborne Pathogens standard.

OSHA believes that an Infectious Diseases rule would help assure that all employers comply with these diverse requirements as part of a comprehensive duty to protect workers from the hazards associated with exposure to infectious agents.  If OSHA finds, through the rulemaking process, that some provisions of existing standards become duplicative, unclear, or confusing, it may choose to modify the requirements of some existing standards or to modify a proposed Infectious Diseases standard.  OSHA will seek comment during the SBAR process and throughout the rulemaking on provisions that may need to be modified.

      Section VIII.  Description of Regulatory Alternatives and Options

   I. Introduction

Per Section 603(c) of the RFA, if OSHA proposes a rule based on its regulatory framework, it must, in its Initial Regulatory Flexibility Analysis, describe any significant alternatives to the proposed rule that accomplish the stated objective of the OSH Act to "assure so far as possible every working man and woman in the Nation safe and healthful working conditions, 29 USC 651(b), and, at the same time, minimize any significant economic impact of the proposed rule on small entities.  To this end, in Part II of this section, and pursuant to Section 609(b) of the RFA, OSHA asks SERs to suggest to the Panel alternatives to the regulatory framework that they believe would accomplish the OSH Act's protective purpose and minimize any significant economic impact on small entities.  In Part II, OSHA also asks SERs to suggest to the Panel regulatory options associated with promulgating an infectious diseases standard.  While these options are not alternatives for purposes of the RFA, OSHA believes that discussing these options at this stage will aid the rulemaking process.

Part III of this section describes regulatory alternatives to the regulatory framework that the Panel developed that would minimize the significant economic impact on small entities.  To allow the SERs to fully understand these alternatives, OSHA provides the SERs with any preliminary determinations the Agency has made about whether the alternatives would accomplish the stated objective of the Act.  OSHA asks SERs to comment on these alternatives and OSHA's preliminary determinations to help the Agency make an informed judgment about whether these alternatives would sufficiently protect employee health.

Part IV of this section examines regulatory options that OSHA is considering.  OSHA asks SERs to comment on these options and OSHA's preliminary determinations about these options to help the Agency make an informed judgment about whether these options would sufficiently protect employee health.

   II. OSHA Asks SERs to Suggest Alternatives and Options

As discussed in the issues paper attached to the SER Background Document, SERs are invited to suggest alternatives and options of their own choice, based on their view of what works and is needed in their kind of facility and what does not work or is unnecessary.  The Panel is particularly interested in comments on whether portions of the regulatory framework would have significant costs, but little or no benefit, in a particular kind of facility.  The Panel is also interested in comments from SERs indicating those provisions of the regulatory framework they do not already follow, why they do not follow those provisions, and the anticipated costs of implementing those provisions.

In addition, OSHA is interested in feedback from the SERs on the necessity and usefulness of individual provisions in the regulatory framework.  To this end, OSHA asks SERs to respond to the following question:

      * What provisions, if any, do you believe you would have to implement as a result of this potential rule that, in your opinion, would not improve worker safety?
Finally, the Agency is interested in the SERs' views on whether there are additional provisions, not contained in the regulatory framework, that are necessary in order to improve worker safety.  To this end, OSHA asks SERs to respond to the following question:

      * What, if any, additional provisions do you think should be added to the framework, and why?
In commenting on the rule's specific provisions, OSHA asks SERs to keep in mind that elimination of provisions in the regulatory framework would not impact requirements contained in existing standards.  For example, as explained in Section IV, Description of the Important Components in the Regulatory framework, the Respiratory Protection standard (29 CFR 1910.134) generally applies to the use of respirators by workers performing tasks that would be covered by a rule as outlined in the regulatory framework.  The applicability of, and costs associated with complying with, the Respiratory Protection standard do not depend on the inclusion in the regulatory framework of respiratory protection provisions.  Moreover, OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) contains requirements related to the safe handling, processing, storage, transport, shipping and disposal of contaminated materials.  The applicability of, and costs associated with complying with, the Bloodborne Pathogens standard do not depend on the inclusion of such provisions in the regulatory framework.

   III.    Alternatives to the Regulatory framework That Would Minimize Any Significant Economic Impact of the Proposed Rule on Small Entities

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Alternative 1 would develop an infectious diseases rule that is specification-oriented rather than performance-oriented.

The regulatory framework is a flexible, performance-oriented approach that reflects what OSHA believes conscientious employers are already doing.  Under this alternative, OSHA would promulgate a specification-oriented standard (i.e., an approach that spells out exactly what employers must do to comply with the standard).  Such a specification-oriented approach would provide less flexibility, but greater clarity, than a performance-oriented approach.

A rule as outlined in the regulatory framework would require affected employers to assess the infectious disease hazards present in their facilities, and develop and implement appropriate infection control plans that are relevant to those hazards.  Infection control plans would also need to be consistent with recognized and generally accepted control practices, which OSHA recognizes, are generally contained in regulations and guidelines, such as the 2007 CDC/HICPAC guidelines (Siegel et al., 2007) and the BMBL guidelines (CDC/NIH, 2009).   Therefore, under this possible approach, OSHA would require employers to consider applicable regulations and guidelines in developing their infection control plans.  OSHA believes this possible approach offers employers a significant amount of flexibility, since development and implementation of an infection control plan would be dependent on the hazards present.  For instance, the Agency believes it is unlikely that a podiatrist's office would need to develop and implement a respiratory protection program under the regulatory framework.

OSHA believes that, in promulgating a specification-oriented infectious diseases rule, the Agency would likely fail to anticipate all of the potential hazards, and, therefore, all of the necessary controls, for every type and every size of facility.  As such, such a rule would under-protect workers to the extent the rule did not include specifications to address particular hazards.  Similarly, a specification-oriented approach would likely result in requiring employers to implement some protective measures that are not applicable to their facilities.

While structuring an OSHA standard using performance-based language, such as the language presented in the regulatory framework, has distinct advantages, such a rule also is not without some drawbacks.  Because the rule does not lay out explicit requirements for each type of affected firm, employers must develop and implement their own infection control plans.  OSHA believes that the affected firms have sufficient familiarity with infection control practices to meet these requirements, but the Agency is interested in the views of the SERs.

Specifically, OSHA is interested in whether SERs would find it difficult to determine how a rule based on the regulatory framework would apply in their facilities, or how OSHA would enforce the performance-oriented provisions in the regulatory framework.  OSHA is also interested if SERs think that OSHA should promulgate a specification-oriented standard that spells out exactly what employers must do to comply with each provision.  OSHA also asks SERS to respond to the following questions:

      * Do SERS find the performance-based approach outlined in the regulatory framework to be flexible?
      * How could OSHA structure a potential rule in order to provide additional flexibility?
      * Do you feel confident that you could interpret the potential requirements included in the regulatory framework well enough to be in compliance with an infectious diseases rule?
      * Do you understand what needs to be done at your facility when a provision is not applicable to your setting?
      * Are there any specific provisions that you believe are unclear that OSHA should clarify or eliminate?
      * Are there areas where greater specification would be useful (i.e., for certain types of facilities or for certain provisions)?
      * What compliance assistance could OSHA provide if a rule as outlined in the regulatory framework were promulgated to best help small entities comply in the least burdensome manner?

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Alternative 2 would rely on enforcement under the General Duty Clause.

OSHA would decide not to promulgate a new rule addressing occupational exposure to infectious diseases.  Instead, OSHA would issue guidance on workplace exposures to infectious diseases recommending that employers follow current guidelines, such as those issued by the CDC, CDC/HICPAC, and NIH, and then attempt to protect workers exposed to infectious agents through enforcement of the OSH Act's General Duty Clause (29 USC 654(a)(1)).  The General Duty Clause requires "[e]ach employer" to "furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees" (id.).  To establish that an employer exposed its employees to infectious disease hazards in violation of the General Duty Clause, OSHA would need to establish, in part, that the hazard was recognized and that a feasible and useful method exists to correct the hazard.  For example, OSHA would show that an employer had knowledge of, and would have followed, applicable federal, state and local regulations, and current guidelines.

OSHA does not believe that this approach would adequately protect workers with occupational exposure to infectious diseases.  A rule based on the regulatory framework would require employers to, among other things, develop and follow worker infection control plans, conduct medical surveillance, and provide medical removal protection benefits.  Some elements of the regulatory framework go beyond what is addressed in current regulations and guidelines.  OSHA believes that all of the provisions of the regulatory framework would work in concert to minimize the spread of infectious disease to workers; the use of enforcement actions under the General Duty Clause would be a much less comprehensive approach to addressing workplace exposures to infectious diseases.  Thus, the promulgation of a rule based on the regulatory framework would be more protective of employee health than enforcement based on the General Duty Clause.  In addition, federal enforcement of the General Duty Clause would not necessarily protect employees in the 25 states and 2 U.S. Territories that operate their own OSHA-approved occupational safety and health plans; even though all state plan states have adopted statutory provisions that are comparable to the OSH Act's General Duty Clause, they were not required to do so, and need not enforce such statutory provisions to the same extent as federal OSHA.  (State plans do need to promulgate standards that are at least as effective as standards promulgated by federal OSHA.)  And finally, enforcement solely through the General Duty Clause is disfavored because it can impose heavy litigation burdens on both OSHA and employers.

Given the limitations associated with enforcement under the General Duty Clause, choosing this non-regulatory alternative would not do as much to accomplish the goals of the OSH Act as the promulgation of a comprehensive standard on workplace exposures to infectious diseases.  Thus, OSHA does not believe this would be a desirable approach as long as there is a viable rulemaking alternative (see Section II, Legal Basis for an OSHA Standard Addressing Occupational Exposure to Infectious Diseases).  OSHA welcomes comments from SERs on non-regulatory alternatives.  In commenting on this issue, OSHA asks SERs to examine the preliminary conclusions OSHA made in Section III of this SER Background Document, Reasons Why Action by the Agency is Being Considered.  For example, SERs may examine and comment on the evidence on which OSHA based its preliminary conclusions that:  (1) there is a well-recognized risk to workers associated with exposure to infectious agents during the provision of direct patient care and/or performance of other covered tasks; (2) current infection control guidelines are non-mandatory, are not consistently and rigorously followed, and therefore are not sufficient to adequately reduce the risk of transmission of infectious agents to workers who provide direct patient care and/or perform other covered tasks; and (3) following recognized and generally accepted good infection control practices considerably reduces the risk of transmission of infectious agents to workers providing direct patient care and/or performing other covered tasks.

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Alternative 3 would exempt very small entities (those with fewer than 20 workers) from all requirements of an infectious diseases rule.

Under this alternative, very small entities (i.e., entities with fewer than 20 workers) would be exempted from all requirements of an infectious diseases rule. Approximately 87 percent of the 637,000 entities that OSHA has preliminarily determined to be affected by a rule as outlined in the regulatory framework are very small establishments with fewer than 20 workers.  Approximately 1.5 million of the estimated 9 million workers affected by a rule as outlined in the regulatory framework work in very small entities.  Thus, exempting very small entities from all requirements of an infectious diseases rule would result in only about 82,000 entities and 7.5 million workers remaining in the scope.
OSHA believes strongly that exempting workers based solely on the size of their employer's firm is inconsistent with the objectives of the OSH Act.  Congress emphasized in the OSH Act, without reference to the size of individual firms, "every working man and woman" has a right to "safe and healthful working conditions." 29 USC 651(b).  OSHA believes that exempting workplaces solely on the basis of size (number of workers) would not provide adequate protection to workers at very small establishments, as workers providing direct patient care and performing other covered tasks in very small establishments also face an elevated risk of occupational exposure to infectious diseases.  Additionally, because of the overall shift in the delivery of healthcare services away from larger institutional settings to smaller settings or home healthcare, the Agency is concerned that exempting establishments solely on the basis of size would, over time, have an adverse effect on an increasing proportion of workers.

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Alternative 4 would apply an infectious diseases rule to workers providing direct patient care, but not to workers performing other covered tasks.

Under this alternative, OSHA would restrict an infectious diseases rule to workers who have occupational exposure during the provision of direct patient care and not cover those workers with occupational exposure during performance of other covered tasks (as those terms are used in the regulatory framework).  Based on the figures in the industry profile presented in Section V of this SER Background Document, OSHA calculates that this alternative would reduce the number of workers affected by such a rule by from about 9 to about 8 million workers: a reduction of approximately 1 million workers.  About 500,000 of these one million workers would be employed at SBA defined small businesses. This alternative would reduce the number of affected workers employed at SBA defined small businesses from about 5.8 to about 5.3 million workers, which includes, among other employees described in the industry profile, a reduction of approximately:  69,000 employees at approximately 4,000 diagnostic laboratories, 19,000 medical waste and laundry handlers at approximately 6,000 establishments, and more than 54,000 morticians, medical examiners, and other health care service providers employed at approximately 11,000 morgues/mortuaries.

While the majority of workers with occupational exposure are engaged in direct patient care, there is also occupational exposure in workers performing other covered tasks, including, but not limited to: providing patient support services (e.g., triage, reception, housekeeping, food services, facility maintenance); handling, transporting, receiving or processing contaminated materials (e.g., laundering healthcare linens, transporting medical specimens, disposing of medical waste, reprocessing medical equipment); maintaining, servicing or repairing contaminated medical equipment; conducting autopsies (e.g., in medical examiners' offices); performing mortuary services; manipulating and analyzing cultures, specimens, and/or human remains containing infectious agents in diagnostic, research and production facilities; and dispensing medications and/or medical supplies in settings where direct patient care is provided.  While employers would face a cost burden in complying with a rule as outlined in the regulatory framework, OSHA believes, based on the evidence  -  particularly a number of studies it has thus far analyzed  -  that workers performing other covered tasks face a risk of infection because of their occupational exposure.  For example, Henkel et al. (2012) reported that 11 laboratory-acquired infections with select agents occurred in the U.S. between 2004 and 2011.  In addition, at least ten laboratory-acquired Vaccinia infections were reported following occupational exposure to the virus (Byers, 2005, Lewis et al., 2006). And in another example, laundry workers who had contact with contaminated linen in a nursing home in Tennessee suffered the highest attack rate of salmonellosis among the nursing home's workers despite having had no direct contact with infected patients (Standaert et al., 1994). Therefore, the Agency chose to include these workers in the regulatory framework.

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Alternative 5 would exempt very small employers (those with fewer than 20 workers) from written documentation requirements.

Under this alternative, employers with fewer than 20 workers would not be subject to written documentation requirements.  Per the regulatory framework, OSHA would require covered employers to have a written worker infection control plan (WICP), WICP review records, medical records, and exposure incident records.  Therefore, this alternative would decrease the paperwork burden on very small employers.  However, OSHA believes it would be virtually impossible to adequately train workers and assure they are routinely and rigorously implementing the employer's infection control plan without a written plan, as the written plan would contain all the Standard Operating Procedures (SOPs) that workers would need to follow to protect themselves.
Inadequate training would, in turn, lead to a higher degree of risk for these workers.  It is also important for workers to have access to a written WICP so that workers can review SOPs for newly assigned procedures or review SOPs for their current activities.  Finally, it is crucial to document exposure incidents to allow for adequate medical follow-up and contact tracing (i.e., tracing the line of exposure to other workers or patients who also may have had exposure or who may have been a source of exposure), and to update the WICP to account for new or emerging infectious agents or changes in community patterns of infectious diseases (e.g., emergence of an antibiotic resistant infectious agent, an outbreak, or a change in prevalence of an infectious disease).
Moreover, OSHA believes that many employers of workers with occupational exposure have already developed and implemented infection control plans in their workplaces, as these actions are required for accreditation by the Joint Commission and other CMS approved accrediting agencies in order to receive funding through CMS.  In addition, OSHA believes that many employers of workers that would be covered by a rule as outlined in the regulatory framework have already developed and implemented infection control plans in their workplaces to meet the requirements of the Bloodborne Pathogens standard, the recommendations of CDC/NIH's Biosafety in Microbiological and Biomedical Laboratories, and/or the recommendations of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. These existing infection control plans would only need to be expanded to include additional elements relevant to a rule as outlined in the regulatory framework.  The amount of additional documentation that would be required under a rule as outlined in the regulatory framework would therefore be minimal for these workplaces.

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Alternative 6 would exclude from an infectious diseases rule any requirement that employers that have workers that provide direct patient care include contact precautions in their SOPs.

Under this alternative, employers would not be required to develop, implement, and update SOPs for contact precautions.  The regulatory framework uses the term contact precautions to mean infection control practices designed to prevent or minimize transmission of infectious agents spread by direct contact (i.e., infectious agent transmission from one infected individual to another individual without a contaminated intermediate item or surface, or individual) or indirect contact (i.e., infectious agent transmission through a contaminated intermediate item or surface, or individual).  If the Agency adopted this alternative, its approach would more closely align with that taken by the California Division of Occupational Safety and Health (Cal-OSHA), when it promulgated its Aerosol Transmissible Diseases standard in 2009 (California OSHA, 2009).  The Cal-OSHA standard was promulgated to protect workers from exposure to droplet- and airborne-transmissible diseases, but not to contact-transmissible diseases.  OSHA believes that Cal-OSHA's approach does not adequately protect workers because, based on the evidence the Agency has thus far analyzed, there are a number of contact-transmissible diseases that pose an elevated risk to workers who provide direct patient care and/or perform other covered tasks.  Occupational exposure of workers to contact-transmissible infectious agents such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin resistant Enterococcus (VRE), is quite common in healthcare settings and is of concern to OSHA.  In a recent publication on MRSA that reviewed 127 studies, for example, it was estimated that approximately 5 percent of healthcare workers are colonized with MRSA and 5 percent of these develop infections (Albrich & Harbarth, 2008).  Based upon this and other peer-reviewed studies, it is OSHA's position that failing to cover contact-transmissible infectious agents in an infectious disease rule would not protect workers adequately.

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Alternative 7 would exclude from an infectious diseases rule any requirement that employers make vaccinations available.

Under this alternative, employers would not be required to make vaccinations available to workers.  The alternative would also eliminate the paperwork burden associated with recordkeeping requirements for vaccine administration and signed vaccine declination statements, and eliminate vaccination-related training that would be required by a rule as outlined in the regulatory framework.  However, vaccination is generally considered an important component of an effective infection control program, as it protects inoculated workers from infections, lessens chances of outbreaks by minimizing transmission of infections from workers to other workers and patients, and may also lessen the duration and severity of infections, depending on the efficacy of the vaccine.  The recommendations of CDC's Advisory Committee on Immunization Practices (ACIP) assert that "optimal use of recommended vaccines helps maintain immunity and safeguard [healthcare workers] from infection" (Shefer et al., 2011).  Therefore, as in OSHA's Bloodborne Pathogens standard (§1910.1030), OSHA thinks it is important to require employers to make vaccinations available to workers.

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Alternative 8 would exclude from an infectious diseases rule any requirement that employers provide medical removal protection benefits.

Under this alternative, employers would not be required to provide medical removal protection (MRP) benefits.  Not incorporating such a provision in an infectious diseases rule would decrease employers' compliance costs, specifically, the cost of paying a worker's total normal earnings, and maintaining the worker's seniority, rights, and benefits, when the worker has been removed from his or her job or otherwise medically limited as a result of occupational exposure.
While OSHA has not calculated the total costs related to medical removal protection, the Agency believes that the costs will be minimal for most employers, especially because full implementation of the provisions in a rule as outlined in the regulatory framework would reduce the need for medical removal protection.  The provisions of the regulatory framework are aimed at preventing or minimizing worker contact with potentially infectious agents and, if fully implemented, a rule as outlined in the regulatory framework would greatly reduce the number of occupationally-acquired infections in the workers covered.  In addition, if OSHA required employers to provide MRP benefits, this would encourage worker participation in (and therefore increases the effectiveness of) any medical surveillance program that would be required, by ensuring that reporting symptoms or health conditions will not result in loss of job or pay.  Without a requirement for MRP benefits, workers might be deterred from reporting signs and symptoms that could be indicative of infection and might work while sick (due to concerns about loss of pay or other such punitive consequences), potentially resulting in further infections to co-workers and/or patients.  Most occupationally acquired infectious diseases that would require extensive leave under a medical removal provision are seen relatively infrequently - especially since, under the regulatory framework, OSHA would not require MRP benefits for most workers who are removed from their jobs or otherwise medically limited as a result of occupational exposure to the common cold or influenza.  Many employers would have no cases in any given year.  However, OSHA seeks input on whether the MRP provision would have significant economic impacts on small or very small firms in the relatively uncommon circumstance of an employee being removed from the workplace because of a long-term serious illness.

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Alternative 9 would only include initial training and training-as-needed in an infectious diseases rule.

Under this alternative, OSHA would not require employers to conduct annual training for workers. Under the regulatory framework, annual training would, at a minimum, include: information on the types, proper use, limitations, location, handling, decontamination, removal, and disposal of PPE; all of the SOPs developed as part of the WICP that are applicable to the worker's duties; and information on vaccine(s) that will be made available to the worker in the year of the training (including their efficacy, contraindications, likelihood and severity of possible adverse health effects, method of administration, the benefits of being vaccinated, and that the vaccines and vaccinations will be offered at no cost and at reasonable times and places).  Not including these provisions in an infectious diseases rule would decrease the burden for all employers.  Research, however, shows that an effective training program, which includes annual training, is essential to ensuring that workers understand the hazards to which they are exposed and how employers must protect them from these hazards (Bolyard et al., 1998).  Effective training can result in fewer injuries and illnesses, better morale, and lower insurance premiums, among other benefits.  Inclusion of an annual training requirement reflects OSHA's belief that training is an essential part of every employer's safety and health program for protecting workers from injuries and illnesses (Bolyard et al., 1998), and that workers will not be adequately protected unless they regularly receive information about the safety and health aspects of their jobs. In its review of current scientific literature related to occupational exposure to infectious agents, OSHA found nearly 100 studies that supported the need for such training programs to ensure worker familiarity with general infection control practices, proper use of PPE, effective hand hygiene, and other methods for reducing occupational exposure (see, e.g., Aboumatar et al., 2012; Nichol et al., 2013; Chen et al., 2011).
Moreover, even if OSHA does not require annual training in an infectious diseases rule, this would not affect a requirement that employers conduct supplemental training that is tied to the employer's WICP.  Under the regulatory framework, OSHA would require the employer to conduct supplemental training to address changes in the WICP.  And, per the regulatory framework, OSHA would require the WICP to be reviewed and updated at least annually, and whenever necessary to reflect various changes in occupational exposure.  So given the regulatory framework's provisions for supplemental training, the alternative of not requiring annual training would not significantly limit the overall training burden on employers.

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Alternative 10 would add additional time for small employers to phase-in compliance with an infectious diseases rule.

A phase-in of an infectious diseases rule would have several advantages in regards to potential impacts on small businesses.  First, it would reduce the one-time initial costs of such a rule by spreading these costs out over time.  A differential phase-in for smaller firms would also assist very small firms in developing and implementing a WICP specific to their workplace based upon the experience of larger firms.  However a phase-in would also postpone the benefits of an infectious diseases rule.

   IV. Regulatory Options Under Consideration

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Option 1 would include in the scope of an infectious diseases rule workers who perform first aid only.

Under this option, workers who perform first aid only would be considered to provide direct patient care for the purposes of an infectious diseases rule.  Inclusion of these workers would substantially increase the number of covered workers.  However, OSHA believes the resulting increased burden on employers is unnecessary for reducing the health hazards posed by infectious diseases.  First aid primarily involves attention to persons with conditions such as cardiac or respiratory arrest, small lacerations (cuts), insect stings and bites, poisonings, and burns, not attention to persons with infectious diseases.  Moreover, OSHA believes that general public health measures are adequate to protect first aid workers from the types of infectious agents covered by a rule as outlined in the regulatory framework, and thus that it is not necessary to impose the burden of implementing and maintaining a comprehensive infection control plan for such workplace exposures.

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Option 2 would define other covered tasks to include a greater range of tasks (e.g., tasks done by teachers and prison guards) and to cover tasks performed by flight attendants while on airplanes.

Under this option, in addition to tasks that would be covered by a rule as outlined in the regulatory framework, other tasks, such as tasks performed by teachers and prison guards would fall within the scope, even when these workers are not performing other covered tasks, as that term is used in the regulatory framework.  In addition, the scope would be expanded to include the tasks performed by flight attendants when they are working on airplanes.
Per the regulatory framework, OSHA would cover healthcare-related and certain other limited tasks, such as mortuary services and laboratory activities.  Expanding the scope of an infectious diseases rule beyond the regulatory framework would greatly increase the number of employers that would be required to comply.  Including prison guards, child daycare teachers, and elementary and secondary school teachers would add an additional 5 million workers to the scope of an infectious diseases rule and affect approximately 99,000 additional establishments. Adding flight attendants would result in coverage for approximately 88,000 more workers and 467 additional establishments.
The tasks that would be covered by a rule as outlined in the regulatory framework  -  unlike the typical duties of workers such as prison guards, teachers and flight attendants  -  would generally be subject to the standard and transmission-based precautions laid out in the CDC/HICPAC guidelines. Many of the programmatic elements contained in the regulatory framework are already in place for the tasks that would be covered by a rule as outlined in the regulatory framework, but that is not the case for tasks in this option.  Development and implementation of these programmatic elements could be expensive for the employers affected by the option.  Moreover, OSHA believes, based on the evidence it has thus far analyzed, that general public health measures are adequate to protect workers performing the tasks outlined in this option, and that it is not necessary to impose the burden of implementing and maintaining a comprehensive infection control plan for such workplace exposures.

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Option 3 would define direct patient care to include all tasks performed by pharmacists that involve face-to-face contact.

In this option, the direct patient care definition would include all the tasks of pharmacists that involve face-to-face contact.  Covering these additional tasks of pharmacists would increase the number of employers that would be required to comply with an infectious diseases rule, adding approximately 172,000 more workers to the scope of this rule and affecting approximately 72,000 additional establishments.
The regulatory framework defines direct patient care, in part, as job duties involving hands-on or face-to-face contact with patients. An exception for pharmacists in the regulatory framework states that pharmacists who provide hands-on care (e.g., administer vaccinations) provide direct patient care, while those who perform duties that involve face-to-face contact only (e.g., dispense medications) do not provide direct patient care.  This option would eliminate this exception to the direct patient care definition.
OSHA believes, based on the evidence it has thus far analyzed, that general public health measures are adequate to protect pharmacists who neither provide direct patient care nor perform other covered tasks, as those terms are used in the regulatory framework, and that the cost of implementing and maintaining a comprehensive infection control plan for the tasks of all pharmacists would impose an unreasonable burden on employers. However, OSHA will continue to examine these job tasks carefully, and may explore ways to specifically address the infectious disease hazards that may be associated with the tasks of this job classification in the future.  The Agency is seeking input on whether it should cover these tasks.
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Option 4 would add increased specificity to the exposure determination that could be required.

This option would require the exposure determination to contain a list of all job classifications and job tasks in which all or some of the workers have occupational exposure.  Under the regulatory framework, the employer would provide a list of job classifications for the exposure determination, but would not need to prepare a list of job tasks.  OSHA believes that including a list of tasks workers perform where occupational exposure occurs would impose an unnecessary paperwork burden on employers.
Moreover, while the Agency expects that some employers may choose to add an additional list of tasks and procedures for the job classifications identified, at this time OSHA does not believe that it should require this increased specificity.  Such specificity may lead to over-reliance on a list of specific tasks that may be incomplete when developing training programs, selecting PPE, and implementing other requirements of an infectious diseases rule, particularly considering the difficulty associated with anticipating all tasks that may be required as part of workers providing direct patient care and/or performing other covered tasks. OSHA recognizes that the nature of treating patients and completing tasks related to healthcare is dynamic, and that developing lists of specific job tasks associated with job classifications may be counterproductive and may result in a lower level of protection for workers.
The Agency is seeking input on the amount of time employers anticipate it would take to develop lists of all job classifications and specific job tasks with occupational exposure, as well as the utility of such an undertaking.

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Option 5 would require written documentation for infectious agent hazard evaluations.

Under this option, employers would be required to document infectious agent hazard evaluations.  Per the regulatory framework, OSHA would require employers to conduct, but not necessarily document, these evaluations (which the regulatory framework defines as assessments to determine the presence of suspected or confirmed sources of infectious agents to which workers have occupational exposure during provision of direct patient care and/or performance of other covered tasks).  Under the regulatory framework, OSHA would require employers to develop, implement, and update procedures to promptly identify suspected or confirmed sources of infectious agents that are present in the work setting by conducting timely infectious agent hazard evaluations.  In the regulatory framework, OSHA thus envisions an ongoing process meant to ensure that workers are continually protected from hazards that may change frequently due to the variety of infectious agents circulating in the community, the types of patients a facility receives, and other factors.  The regulatory framework provides further that infectious agent hazard evaluations may be incorporated into routine activities, such as triage.
OSHA believes that requiring employers to document infectious agent hazard evaluations would increase both the paperwork burden, through additional requirements for written documentation and recordkeeping, and the cost, through time required to achieve compliance for employers.  Further, the Agency believes that a documentation requirement would not advance (and might even detract from) OSHA's goal in the regulatory framework that occupational exposure to infectious agent hazards be continually evaluated in an ongoing fashion.  Finally, OSHA believes that the recordkeeping provisions that are currently in the regulatory framework would sufficiently protect workers.  For example, per the regulatory framework, OSHA would require employers to keep exposure incident records, which would allow the employer to document elements such as the work setting and work task(s) being performed when the exposure incident(s) occurred, which would, in turn, allow the employer to focus efforts on decreasing or eliminating specific circumstances or routes of exposures that caused the incident(s).
OSHA believes that requiring employers to keep infectious agent hazard evaluations in written form would not greatly improve protection of workers beyond what would be achieved with the recordkeeping provisions that are currently in the regulatory framework.

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Option 6 would require hospitals to follow the hierarchy of controls as required in OSHA's Respiratory Protection Standard (29 CFR 1910.134(a)(1)), and to have in their workplaces an appropriate number of airborne infection isolation rooms (AIIRs).

Under this option, adherence by hospitals to the required hierarchy of controls as required in 29 CFR 1910.134(a)(1), would not be modified in accordance with recognized and generally accepted good infection control practices.  This option, therefore, would require hospital employers to prevent or minimize airborne transmission of infectious agents in their work settings by first installing and employing effective engineering controls, i.e., an appropriate numbers of AIIRs, based on expected demand for airborne isolation.

OSHA recognizes that infection control practices normally rely upon a multi-layered and overlapping strategy of employing engineering, work practice and administrative controls, and PPE.  Therefore, in the regulatory framework, OSHA notes that the Agency would permit adherence to the required hierarchy of controls, such as that required by 29 CFR 1910.134(a)(1), to be modified in accordance with recognized and generally accepted good infection control practices.
OSHA's review of the scientific literature suggests that, when maintained and used properly, using AIIRs is an effective method for controlling the spread of airborne infectious agents (see, e.g., Parvez et al., 2010; Roberts et al., 2006; Saravia et al., 2007; Stroud et al., 1995).  On the other hand, OSHA believes that workers will be adequately protected through compliance with a requirement that employers must develop, implement, and update airborne precautions that are consistent with recognized and generally accepted good infection control practices relevant to their work settings.  Moreover, per section IV of the regulatory framework (Standard Operating Procedures Development and Implementation), OSHA would require employers that provide services in medical surge conditions to develop, implement, and update procedures for the implementation of temporary control measures, including the use of temporary engineering controls used to establish temporary airborne infection isolation areas, or AIIAs, where appropriate.  This provision, if promulgated, would provide additional protection.

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Option 7 would require all employers to provide medical removal protection benefits for common cold and influenza.

This option would apply medical removal protection (MRP) benefits to all infectious diseases, including influenza and the common cold.  Per the regulatory framework, OSHA would require employers to pay a worker's total normal earnings, and maintain the worker's seniority, rights, and benefits, when the worker has been removed from his or her job or otherwise medically limited as a result of occupational exposure, but would not generally require employers to provide these benefits when a worker is removed from his or her job or otherwise medically limited as a result of occupational exposure to the common cold or influenza.
Requiring employers to provide MRP benefits encourages worker participation in (and therefore increases the effectiveness of) the medical surveillance program that would be required by an infectious diseases rule by ensuring that reporting symptoms or health conditions will not result in loss of job or pay.  The expansion of MRP benefits to cover influenza and the common cold would likely reduce additional infections in coworkers and/or patients.  Moreover, exclusion of the common cold and influenza, frequent occupational exposure to both of which is supported by scientific evidence, could deter workers from reporting signs and symptoms consistent with cold or influenza (e.g., cough, runny nose, sneezing, sore throat, muscle aches, tiredness) that may also be indicative of infection with other, potentially more serious, agents.

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Option 8 would require employers whose workplace settings have workers that provide direct patient care to develop and display signage in patient rooms encouraging patients to request that workers use proper hand hygiene before any direct patient care is provided.

Under this option, employers would be required to develop and display signage in patient rooms encouraging patients to request that workers use proper hand hygiene before any direct patient care is provided.  CDC encourages patients to ask or remind HCWs to wash their hands (CDC, 2010b).  Wu et al. (2013) found that patients were willing to participate in such initiatives to improve hand hygiene among HCWs; and McGuckin et al. (2004) found that, when patients asked HCWs to use soap or hand sanitizer products, HCWs washed or sanitized their hands about 4.7 times more per day compared with HCWs not asked about hand hygiene by patients in the study.  This option would not only ensure placement of visual reminders to HCWs and workers performing other covered tasks to use proper hand hygiene, but would also help to promote a general culture of good hand hygiene for organizations by incorporating patient awareness and possible resulting action(s).  However, printed signs would create additional compliance costs for employers, and represent an increased paperwork burden.  OSHA invites stakeholder comment about the efficacy and cost of this option.

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Appendix A  -  SBA Definitions of Small Entities for all Affected Industries at the Six-Digit NAICS Level

Appendix B  -  Regulatory framework Crosswalk with Published Infection Control Guidelines/Regulations

Although OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) protects workers from occupational exposure to bloodborne pathogens, there are no other mandatory federal standards that protect workers from occupational exposure to the various infectious agents to which they may be exposed.  However, infection prevention and control is a recognized and generally accepted practice in the healthcare industry, and, to this end, numerous non-mandatory guidelines on infection prevention and control provide recommendations for the protection of patients and workers from infectious agents.

Despite these recommendations, the focus of infection control practices, in general, has been on the protection of patients, with the common understanding that by reducing the transmission of infectious agents from healthcare workers to patients and between patients, the overall risk of exposure to healthcare workers would likely be reduced as well.  Thus, the Centers for Medicare and Medicaid (CMS), as well as non-governmental organizations (e.g., CMS-approved accreditation organizations such as the Joint Commission), rely on recognized and generally accepted good infection prevention and control guidelines in developing their own programs

The Agency has been developing an extensive crosswalk comparing the provisions of the regulatory framework with existing guidelines and regulations for infectious disease prevention and control in workplaces where workers provide direct patient care and/or perform other covered tasks (as those terms are defined in the regulatory framework). The crosswalk currently contains 39 documents, and OSHA is working to analyze additional guidelines and regulations for inclusion.  See List of Guidelines and Regulations OSHA Has Thus Far Analyzed, directly below this discussion.

OSHA concludes, based on the comparison it has thus far done, that many provisions in the regulatory framework are consistent with recommended infection control practices described in the crosswalk documents.  For example, both the regulatory framework and infection control practices described in the 2007 CDC/HICPAC Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (Item 29 in the crosswalk), emphasize standard and transmission-based precautions to reduce the risk of transmission of infectious agents.  Moreover, the 2007 guidelines contain infection control practices applicable to healthcare facilities (e.g., acute care hospitals, home care settings, and ambulatory care settings), which are addressed by the regulatory framework.   The documents in the crosswalk also cover such diverse settings as behavioral health settings, dentists' offices, laboratories and funeral homes (Items 7, 12, 14, 22, 24, 25, 30, 32, 36, 37), which are also addressed by the regulatory framework.

The CDC guidelines have been widely accepted and incorporated into healthcare facilities' infection prevention and control programs.  For example, the majority of employers that would be subject to a rule as outlined in the regulatory framework are also subject to CMS regulations (Items 16 thru 23 in crosswalk).  These regulations condition a provider's participation in Medicare or Medicaid on the provider's implementation of an infection control program.  Pursuant to CMS interpretive guidelines, to meet this condition, providers should ensure that their infection control programs conform to recognized and generally accepted infectious control practices and guidelines, such as the CDC/HICPAC guidelines.  See, e.g., CMS State Operations Manual App. A  -  Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, App. PP - Guidance to Surveyors for Long Term Care Facilities, App. J - Guidance to Surveyors: Intermediate Care Facilities for Persons With Mental Retardation.  Furthermore, compliance with the CMS regulations is generally validated through periodic accreditation surveys of facilities by CMS-approved accreditation organizations, including The Joint Commission (TJC), a private not-for-profit organization that evaluates and accredits more than 20,000 healthcare organizations and programs in the United States.  Consistent with these interpretive guidelines, many of the infection prevention and control practices TJC requires to be adopted for accreditation (Items 31 thru 36 of the crosswalk) vary based on healthcare setting, but those practices closely follow the 2007 CDC/HICPAC guidelines.

Finally, OSHA believes that many employers not directly subject to the CMS regulations are familiar with, and may have adopted, infection control programs that are consistent with the regulations and guidelines in the crosswalk, again, because these guidelines and regulations are widely accepted means of addressing infectious agent hazards.  Moreover, OSHA believes that a large number of employers of workers performing other covered tasks, as that term is defined in the regulatory framework (for example, employers of workers performing maintenance and housekeeping in health care settings), work in facilities that are subject to the CMS regulations.

OSHA emphasizes that the crosswalk in this SER Background Document does not represent the universe of relevant guidelines and regulations addressing infection prevention and control.  OSHA is in the process of compiling and analyzing other relevant guidelines and regulations issued by entities such as state licensing boards, trade associations, and credentialing agencies.   However, because OSHA wants to ensure that it examines a representative number of relevant documents, OSHA requests that any guidelines or regulations addressing infection prevention and control that are not listed in the crosswalk be submitted by the regulated community to OSHA for analysis.
         List of Guidelines and Regulations OSHA Has Thus Far Analyzed

1. American Academy of Pediatrics Committee on Infectious Diseases.  2007.  Infection prevention and control in pediatric ambulatory settings.  Pediatrics. 120: 650-665.
2. Bolyard, EA, et al. (CDC/HICPAC).  1998.  Guideline for Infection Control in Healthcare Personnel, 1998.  Infect Control Hosp Epidemiol. 19(6): 407-463.  Available at http://www.cdc.gov/hicpac/pdf/infectcontrol98.pdf (Accessed November 18, 2013).
3. California Department of Public Health.  2007.   Medical Waste Management Act.  California Health and Safety Code Sections 117600  -  118360.  Available at http://www.cdph.ca.gov/certlic/medicalwaste/Documents/MedicalWaste/MedicalWasteManagementAct.pdf (Accessed November 18, 2013).

4. California OSHA.  2009.  California Code of Regulations, Title 8, Section 5199.  Aerosol Transmissible Diseases and Appendices A-G.  Available at http://www.dir.ca.gov/title8/5199.html.  Appendices A through Appendix G available at   http://www.dir.ca.gov/title8/5199a.html through http://www.dir.ca.gov/title8/5199g.html (Accessed November 18, 2013).
5. CDC (Centers for Disease Control and Prevention).  2002.  Guideline for Hand Hygiene in Health-Care Settings: Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force.  Available at http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf (Accessed November 18, 2013).
6. CDC (Centers for Disease Control and Prevention).  2003.  Guidelines for Environmental Infection Control in Health-care Facilities.  Available at http://www.cdc.gov/MMWR/preview/MMWRhtml/rr5210a1.htm (Accessed November 18, 2013).
7. CDC (Centers for Disease Control and Prevention).  2003.  Guidelines for Infection Control in Dental Health-Care Settings.  Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm (Accessed November 18, 2013).
8. CDC (Centers for Disease Control and Prevention).  2005.  Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings.  Available at http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf  (Accessed November 18, 2013).
9. CDC (Centers for Disease Control and Prevention).  2006.  Management of Multidrug-resistant Organisms in Health Care Settings.  Available at   http://www.cdc.gov/hicpac/pdf/MDRO/MDROGuideline2006.pdf (Accessed November 18, 2013).
10. CDC (Centers for Disease Control and Prevention).  2008.  Guidelines for Disinfection and Sterilization in Healthcare Facilities.  Available at http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf (Accessed November 18, 2013).
11. CDC (Centers for Disease Control and Prevention).  2011.  Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care.    Available at http://www.cdc.gov/HAI/pdfs/guidelines/standatds-of-ambulatory-care-7-2011.pdf (Accessed November 18, 2013).
12. CDC (Centers for Disease Control and Prevention), 2012. Guidelines for Human and Animal Medical Diagnostic Labs.  Available at http://www.cdc.gov/mmwr/pdf/other/su6101.pdf (Accessed November 18, 2013).
13. CDC/ACIP (Centers for Disease Control and Prevention/Advisory Committee on Immunization Practices).  2011.  Immunization of Health-Care Personnel Recommendations of the Advisory Committee on Immunization Practices (ACIP).  Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm (Accessed November 18, 2013).
14. CDC/NIH (Centers for Disease Control and Prevention/National Institutes of Health).  2009.  Biosafety in Microbiological and Biomedical Laboratories.  HHS Publication No. (CDC) 21-1112.  Available at http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf (Accessed November 18, 2013).
15. Colorado Department of Public Health and Environment.  2012. Compliance Bulletin  -  Solid Waste - Medical Waste Identification.  Available at http://www.colorado.gov/cs/Satellite?blobcol=urldata&blobheadername1=Content-Disposition&blobheadername2=Content-Type&blobheadervalue1=inline%3B+filename%3D%22Medical+Waste+Identification+Compliance+Bulletin.pdf%22&blobheadervalue2=application%2Fpdf&blobkey=id&blobtable=MungoBlobs&blobwhere=1251813337744&ssbinary=true (Accessed November 18, 2013).
16. CMS (Centers for Medicare and Medicaid Services). 2011.  Ambulatory Surgical Services.  42 CFR Part 416.  Available at http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&rgn=div5&view=text&node=42:<IP_ADDRESS>.3&idno=42 (Accessed November 18, 2013).
17. CMS (Centers for Medicare and Medicaid Services).  2011.  Hospice Care.  42 CFR Part 418.  Available at http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=aa6479dd0aefc620f6f9eeeaa271941e&rgn=div5&view=text&node=42:<IP_ADDRESS>.5&idno=42 (Accessed November 18, 2013).
18. CMS (Centers for Medicare and Medicaid Services). 2011.  Conditions for Participation for Hospitals.  42 CFR Part 482.  Available at http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&sid=b09bd7ac6c8241ae3fa68f5136e5e7d4&rgn=div5&view=text&node=42:<IP_ADDRESS>.1&idno=42 (Accessed November 18, 2013).
19. CMS (Centers for Medicare and Medicaid Services).  2011.  Requirements for States and Long Term Care Facilities.  42 CFR Part 483.  Available at http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=734a63bc1ee85688f395a87718a3b4cb&rgn=div5&view=text&node=42:<IP_ADDRESS>.2&idno=42 (Accessed November 18, 2013).
20. CMS (Centers for Medicare and Medicaid Services).  2011.  Home Health Services.  42 CFR Part 484.  Available at http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=06667da3a09644eb41d5bb4064b6da8f&rgn=div5&view=text&node=42:<IP_ADDRESS>.3&idno=42 (Accessed November 18, 2013).
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