Occupational exposure to bloodborne pathogens; correction--OSHA. Final rule, correction

The Occupational Safety and Health Administration is correcting errors in the regulatory text of the final rule for Occupational Exposure to Bloodborne Pathogens which appeared in the Federal Register on December 6, 1991 (56 FR 64004).     

Occupational exposure to bloodborne pathogens--OSHA. Final rule

The Occupational Safety and Health Administration hereby promulgates a standard under section 6(b) of the Occupational Safety and Health Act of 1970 (the Act), 29 U.S.C. 655 to eliminate or minimize occupational exposure to Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV) and other bloodborne pathogens. Based on a review of the information in the rulemaking record, OSHA has made a determination that employees face a significant health risk as the result of occupational exposure to blood and other potentially infectious materials because they may contain bloodborne pathogens, including hepatitis B virus which causes Hepatitis B, a serious liver disease, and human immunodeficiency virus, which causes Acquired Immunodeficiency Syndrome (AIDS). The Agency further concludes that this exposure can be minimized or eliminated using a combination of engineering and work practice controls, personal protective clothing and equipment, training, medical surveillance, Hepatitis B vaccination, signs and labels, and other provisions.     

Occupational injury and illness recording and reporting requirements. Occupational Safety and Health Administration (OSHA), U.S. Department of Labor. Final rule

The Occupational Safety and Health Administration (OSHA) is revising its rule addressing the recording and reporting of occupational injuries and illnesses (29 CFR parts 1904 and 1952), including the forms employers use to record those injuries and illnesses. The revisions to the final rule will produce more useful injury and illness records, collect better information about the incidence of occupational injuries and illnesses on a national basis, promote improved employee awareness and involvement in the recording and reporting of job-related injuries and illnesses, simplify the injury and illness recordkeeping system for employers, and permit increased use of computers and telecommunications technology for OSHA recordkeeping purposes. This rulemaking completes a larger overall effort to revise Part 1904 of Title 29 of the Code of Federal Regulations. Two sections of Part 1904 have already been revised in earlier rulemakings. A rule titled Reporting fatalities and multiple hospitalization incidents to OSHA, became effective May 2, 1994 and has been incorporated into this final rule as Section 1904.39. A second rule entitled Annual OSHA injury and illness survey of ten or more employers became effective on March 13, 1997 and has been incorporated into this final rule as Section 1904.41. The final rule being published today also revises 29 CFR 1952.4, Injury and Illness Recording and Reporting Requirements, which prescribes the recordkeeping and reporting requirements for States that have an occupational safety and health program approved by OSHA under Section 18 of the Occupational Safety and Health Act (the "Act" or "OSH Act").     

Occupational exposure to tuberculosis--OSHA. Proposed rule and notice of public hearing

The Occupational Safety and Health Administration is proposing a health standard, to be promulgated under section 6(b) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 655, to control occupational exposure to tuberculosis (TB). TB is a communicable, potentially lethal disease that afflicts the most vulnerable members of our society: the poor, the sick, the aged, and the homeless. As many as 13 million U.S. adults are presently believed to be infected with TB; over time, more than 1 million of these individuals may develop active TB disease and transmit the infection to others. TB remains a major health problem with 22,813 active cases reported in the U.S. in 1995. A number of outbreaks of this disease have occurred among workers in health care settings, as well as other work settings, in recent years. To add to the seriousness of the problem, some of these outbreaks have involved the transmission of multidrug-resistant strains of Mycobacterium tuberculosis, which are often fatal. Although it is the responsibility of the U.S. Public Health Service to address the problem of tuberculosis in the general U.S. population, OSHA is solely responsible for protecting the health of workers exposed to TB as a result of their job. OSHA estimates that more than 5 million U.S. workers are exposed to TB in the course of their work: in hospitals, homeless shelters, nursing homes, and other work settings. Because active TB is endemic in many U.S. populations, including groups in both urban and rural areas, workers who come into contact with diseased individuals are at risk of contracting the disease themselves. The risk confronting these workers as a result of their contact with TB-infected individuals may be as high as 10 times the risk to the general population. Although the number of reported cases of active TB has slowly begun to decline after a resurgence between 1985-1992, 16 states reported an increase in the number of TB cases in 1995, compared with 1994. Based on a review of the data, OSHA has preliminarily concluded that workers in hospitals, nursing homes, hospices, correctional facilities, homeless shelters, and certain other work settings are at significant risk of incurring TB infection while caring for their patients and clients or performing certain procedures. To reduce this occupational risk, OSHA is proposing a standard that would require employers to protect TB-exposed employees by means of infection prevention and control measures that have been demonstrated to be highly effective in reducing or eliminating job-related TB infections. These measures include the use of respirators when performing certain high hazard procedures on infectious individuals, procedures for the early identification and treatment of TB infection, isolation of individuals with infectious TB in rooms designed to protect those in the vicinity of the room from contact with the microorganisms causing TB, and medical follow-up for occupationally exposed workers who become infected. OSHA has preliminarily determined that the engineering, work practice, and administrative controls, respiratory protection, training, medical surveillance, and other provisions of the proposed standard are technologically and economically feasible for facilities in all affected industries.     

Occupational exposure to ethylene oxide; Occupational Safety and Health Administration. Advance notice of proposed rulemaking

Notice is given that OSHA is undertaking, through rulemaking procedures under section 6(b) of the Occupational Safety and Health Act of 1970 (the Act), 29 U.S.C. 655(b), a reevaluation of the current occupational health standard regulating employee exposure to ethylene oxide (EtO), 29 CFR 1910.1000, Table Z-1. This notice summarizes the information currently available to OSHA concerning the production and use of EtO, estimates of employee exposure, and the potential health effects of employee exposure to EtO. The notice also invites interested parties to submit data, views and comments regarding the development of a new standard for EtO and the appropriate scope of coverage.     

Nevada State plan; final approval determination. Occupational Safety and Health Administration (OSHA), U.S. Department of Labor. Final State plan approval--Nevada

This document amends OSHA's regulations to reflect the Assistant Secretary's decision granting final approval to the Nevada State plan. As a result of this affirmative determination under section 18(e) of the Occupational Safety and Health Act of 1970, Federal OSHA's standards and enforcement authority no longer apply to occupational safety and health issues covered by the Nevada plan, and authority for Federal concurrent jurisdiction is relinquished. Federal enforcement jurisdiction is retained over any private sector maritime employment, private sector employers on Indian land, and any contractors or subcontractors on any Federal establishment where the land is exclusive Federal jurisdiction. Federal jurisdiction remains in effect with respect to Federal government employers and employees. Federal OSHA will also retain authority for coverage of the United States Postal Service (USPS), including USPS employees, contract employees, and contractor-operated facilities engaged in USPS mail operations.     

Occupational injury and illness recording and reporting requirements. Final rule

The Occupational Safety and Health Administration (OSHA) is delaying the effective date of three provisions of the Occupational Injury and Illness Recording and Reporting Requirements rule published January 19, 2001 (66 FR 5916-6135) and is establishing interim criteria for recording cases of work-related hearing loss. The provisions being delayed are sections 1904.10 (a) and (b), which specify recording criteria for cases involving occupational hearing loss, section 1904.12, which defines "musculoskeletal disorder (MSD)" and requires employers to check the MSD column on the OSHA Log if an employee experiences a work-related musculoskeletal disorder, and section 1904.29(b)(7)(vi), which states that MSDs are not considered privacy concern cases. The effective date of these provisions is delayed from January 1, 2002 until January 1, 2003. OSHA will continue to evaluate sections 1904.10 and 1904.12 over the next year. OSHA is also adding a new paragraph(c) to section 1904.10, establishing criteria for recording cases of work-related hearing loss during calendar year 2002. Section 1904.10(c) codifies the enforcement policy in effect since 1991, under which employers must record work related shifts in hearing of an average of 25 dB or more at 2000, 3000 and 4000 hertz in either ear.     

Occupational exposure to hexavalent chromium. Final rule

The Occupational Safety and Health Administration (OSHA) is amending the existing standard which limits occupational exposure to hexavalent chromium (Cr(VI)). OSHA has determined based upon the best evidence currently available that at the current permissible exposure limit (PEL) for Cr(VI), workers face a significant risk to material impairment of their health. The evidence in the record for this rulemaking indicates that workers exposed to Cr(VI) are at an increased risk of developing lung cancer. The record also indicates that occupational exposure to Cr(VI) may result in asthma, and damage to the nasal epithelia and skin. The final rule establishes an 8-hour time-weighted average (TWA) exposure limit of 5 micrograms of Cr(VI) per cubic meter of air (5 [mu]g/cu m). This is a considerable reduction from the previous PEL of 1 milligram per 10 cubic meters of air (1 mg/10 cu m, or 100 [mu]g/cu m) reported as CrO3, which is equivalent to a limit of 52 [mu]g/cu m as Cr(VI). The final rule also contains ancillary provisions for worker protection such as requirements for exposure determination, preferred exposure control methods, including a compliance alternative for a small sector for which the new PEL is infeasible, respiratory protection, protective clothing and equipment, hygiene areas and practices, medical surveillance, recordkeeping, and start-up dates that include four years for the implementation of engineering controls to meet the PEL. The final standard separately regulates general industry, construction, and shipyards in order to tailor requirements to the unique circumstances found in each of these sectors. The PEL established by this rule reduces the significant risk posed to workers by occupational exposure to Cr(VI) to the maximum extent that is technologically and economically feasible.     

Patient Protection and Affordable Care Act; establishment of exchanges and qualified health plans; exchange standards for employers. Final rule, Interim final rule

This final rule will implement the new Affordable Insurance Exchanges ("Exchanges"), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.     

Dipping and coating operations. Occupational Safety and Health Administration (OSHA), Labor. Final rule

OSHA's standards for dipping and coating operations, codified at sections 1910.108 and 1910.94(d), are designed to protect employees from fire, explosion, and other hazards associated with these operations. On April 7, 1998 (63 FR 16918), OSHA published proposed revisions to these standards in the Federal Register. The Federal Register announcement requested comments on the proposed rule, as well as on three major issues identified by OSHA. Based on these comments and other considerations, the Agency has developed the final standard to accomplish several goals: To rewrite the former standards in plain language; to consolidate the former requirements in sequential sections (sections 1910.122 through 1910.126 in subpart H of part 1910); and to update the former standards to increase the compliance options available to employers. In addition to achieving these goals, OSHA concludes that the final rule being published today will enhance employee protection by making it more understandable and useful to employers and employees and more flexible and performance-oriented than the former rules. The final rule accomplishes these goals without increasing the regulatory burden of employers or reducing employee protection.     

Grants to for-profit organizations; implementing amendments--Public Health Service. Final rule

This issuance amends 42 CFR Part 52 applicable to grants made for research projects under sections 301 and 356 of the Public Health Service Act to delete the prohibition on eligibility for research awards to entities that are organized or operated for profit. Elsewhere in this issue of the Federal Register is a final rule which, among other things, amends 42 CFR Part 87 to allow for-profit organizations to apply for health research and demonstration grants under section 20 of the Occupational Safety and Health Act and section 501 of the Federal Mine Safety and Health Act.     

Age Discrimination in Employment Act; retiree health benefits. Final rule

The Equal Employment Opportunity Commission is publishing this final rule so that employers may create, adopt, and maintain a wide range of retiree health plan designs, such as Medicare bridge plans and Medicare wrap-around plans, without violating the Age Discrimination in Employment Act of 1967 (ADEA). To address concerns that the ADEA may be construed to create an incentive for employers to eliminate or reduce retiree health benefits, EEOC is creating a narrow exemption from the prohibitions of the ADEA for the practice of coordinating employer-sponsored retiree health benefits with eligibility for Medicare or a comparable State health benefits program. The rule does not otherwise affect an employer's ability to offer health or other employment benefits to retirees, consistent with the law.     

World Trade Center Health Program requirements for the addition of new WTC-related health conditions. Final rule

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require that the WTC Program Administrator develop regulations to implement portions of the WTC Health Program established within the Department of Health and Human Services (HHS). The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, PA, and at the Pentagon, and to eligible survivors of the New York City attacks. This final rule establishes the processes by which the WTC Program Administrator may add a new condition to the list of WTC-related health conditions through rulemaking, including a process for considering petitions by interested parties to add a new condition.     

Required warnings for cigarette packages and advertisements. Final rule

The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.     

Medical devices; reclassification of the cutaneous carbon dioxide and the cutaneous oxygen monitor. Final rule

The Food and Drug Administration (FDA) is reclassifying the cutaneous carbon dioxide (PcCO2) monitor from class II (performance standards) into class II (special controls). FDA is also reclassifying the cutaneous oxygen (PcO2) monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls) and is reclassifying the cutaneous oxygen (PcO2) monitor for all other uses from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Class II [[Page 76679]] Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA" that will serve as the special control for the devices. These reclassifications are taken on the agency's own initiative based on new information. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act.     

Orthopedic devices; classification for the resorbable calcium salt bone void filler device. Final rule

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.     

Respiratory protection--OSHA. Final rule; request for comment on paperwork requirements

This final standard, which replaces the respiratory protection standards adopted by OSHA in 1971 (29 CFR 1910.134 and 29 CFR 1926.103), applies to general industry, construction, shipyard, longshoring, and marine terminal workplaces. The standard requires employers to establish or maintain a respiratory protection program to protect their respirator-wearing employees. The standard contains requirements for program administration; worksite-specific procedures; respiratory selection; employee training; fit testing; medical evaluation; respiratory use; respirator cleaning, maintenance, and repair; and other provisions. The final standard also simplifies respirator requirements for employers by deleting respiratory provisions in other OSHA health standards that duplicate those in the final standard and revising other respirator-related provisions to make them consistent. In addition, the standard addresses the use of respirators in Immediately Dangerous to Life or Health (IDLH) atmospheres, including interior structural firefighting. During interior structural firefighting (an IDLH atmosphere by definition), self-contained breathing apparatus is required, and two firefighters must be on standby to provide assistance or perform rescue when two firefighters are inside the burning building. Based on the record in this rulemaking and the Agency's own experience in enforcing its prior respiratory protection standards, OSHA has concluded that compliance with the final rule will assist employers in protecting the health of employees exposed in the course of their work to airborne contaminants, physical hazards, and biological agents, and that the standard is therefore necessary and appropriate. The final respiratory protection standard covers an estimated 5 million respirator wearers working in an estimated 1.3 million workplaces in the covered sectors. OSHA's benefits analysis predicts that the standard will prevent many deaths and illnesses among respirator-wearing employees every year by protecting them from exposure to acute and chronic health hazards. OSHA estimates that compliance with this standard will avert hundreds of deaths and thousands of illnesses annually. The annual costs of the standard are estimated to be $111 million, or an average of $22 per covered employee per year.     

Office of Management and Budget control numbers under the Paperwork Reduction Act--OSHA. Final rule

The Occupational Safety and Health Administration (OSHA) is adding new sections to its Safety and Health REgulations for General Industry, Construction and Shipyard Employment. These new sections will be used to consolidate and display all of the control numbers assigned by the Office of Management and Budget (OMB) for "approved" information collection requirements. OSHA is also identifying information collection requirements found in certain of its other regulations and displaying the OMB control number at the end of each section containing a collection of information. None of the requirements are new; they have been promulgated by OSHA at various times over the past 25 years. The display of OMB control numbers is required under the implementing rules and regulations of OMB and under the Paperwork Reduction Act of 1995.     

The Family and Medical Leave Act of 1993--Wage and Hour Division, Department of Labor. Interim final rule; request for comments

This document contains interim regulations implementing the Family and Medical Leave Act of 1993 called ("FMLA" or "the Act"). The Act is effective on August 5, 1993, six months from the date of its enactment. Where a collective bargaining agreement is in effect on August 5, 1993, the Act is effective when the collective bargaining agreement terminates or February 5, 1994, whichever is earlier. The purpose of these regulations is to set forth the requirements of Title I and Title IV of the Act. Title I applies to covered private employers and public agencies (except for most of the Federal Government, which is governed by Title II). Title IV of the Act primarily concerns the relationship between FMLA and other laws, as well as collective bargaining agreements and other employer plans and programs.     

Cardiovascular and neurological devices; reclassification of two embolization devices. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify two embolization device types from class III (premarket approval) into class II (special controls). The agency is also changing the names and revising the identifications of these devices. The vascular embolization device (previously the arterial embolization device) is intended to control hemorrhaging due to aneurysms, certain types of tumors, and arteriovenous malformations. The neurovascular embolization device (previously the artificial embolization device) is intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. FDA is reclassifying these devices on its own initiative on the basis of new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for these devices.