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.     

Occupational exposure to ethylene oxide--Occupational Safety and Health Administration. Proposed rule and notice of hearing

By this notice, the Occupational Safety and Health Administration (OSHA) is proposing to amend its existing occupational standard that regulates employee exposure to ethylene oxide (EtO). The basis for this action is a determination by the Assistant Secretary, based on animal and human data, that exposure to EtO at OSHA's current permissible exposure limit (PEL) of 50 parts EtO per million parts of air (50 ppm) as an eight (8)-hour time-weighted average (TWA) is inadequate for employee health protection. OSHA proposes to reduce the PEL for EtO to a TWA of 1 ppm. An "action level" of 0.5 ppm as a TWA is included in the proposal as a mechanism for exempting an employer from the obligation to comply with certain requirements, such as employee exposure monitoring and medical surveillance, in instances where the employer can demonstrate that the employees exposures are at very low levels. The proposal would provide for among other requirements certain methods of exposure control, personal protective equipment, measurement of employee exposures, training, medical surveillance, signs and labels, regulated areas, emergency procedures and recordkeeping.     

Occupational exposure to ethylene oxide--OSHA. Final rule: supplemental statement of reasons

On June 22, 1984, the Occupational Safety and Health Administration (OSHA) published a final standard for ethylene oxide (EtO) that established a permissible exposure limit of 1 part EtO per million parts of air determined as an 8-hour time--weighted average (TWA) concentration (29 CFR 1910.1047, 49 FR 25734). The standard also includes provisions for methods of exposure control, personal protective equipment, measurement of employee exposure, training, signs, and labels, medical surveillance, regulated areas, emergencies and recordkeeping. The basis for this action was a determination by OSHA, based on human and animal data, that exposure to EtO presents a carcinogenic, mutagenic, genotoxic, reproductive, neurologic, and sensitization hazard to workers. During the rulemaking proceedings that led to the establishment of the 1 ppm TWA, the issue of whether there was a need for a short-term exposure limit (STEL) for workers protection from EtO was raised. OSHA reserved decision on the adoption of a STEL at the conclusion of the rulemaking in order to permit peer review of the available evidence and to review more fully the arguments and pertinent data regarding the STEL issue. Upon receipt of the analyses from most of the peer reviewers, OSHA published a notice to that effect on September 19, 1984 (49 FR 36659) and invited public comment on the pertinent issues addressed in the peer reviews. Based on the entire rulemaking record, including the peer reviews and public comments received since June 22, the Assistant Secretary has determined that adoption of a STEL for EtO is not warranted by the available health evidence, and that a STEL is not reasonably necessary or appropriate for inclusion in the final EtO standard. OSHA has also asked that NIOSH fund certain additional studies related to whether a dose-rate relationship can be established for EtO, and OSHA will review the results of those studies when they become available.     

Health standards for occupational noise exposure. Mine Safety and Health Administration (MSHA), Labor. Final rule

This final comprehensive rule replaces MSHA's existing standards for occupational noise exposure in coal mines and metal and nonmetal mines. The final rule establishes uniform requirements to protect the Nation's miners from occupational noise-induced hearing loss. The rule is derived in part from existing MSHA noise standards, and from the Department of Labor's existing occupational noise exposure standard for general industry promulgated by the Occupational Safety and Health Administration (OSHA). As a result of the Agency's ongoing review of its safety and health standards, MSHA determined that its existing noise standards, which are more than twenty years old, do not adequately protect miners from occupational noise-induced hearing loss. A significant risk to miners of material impairment of health from workplace exposure to noise over a working lifetime exists when miners' exposure exceeds an 8-hour time-weighted average (TWA8) of 85 dBA. MSHA expects that the final rule will significantly reduce the risk of material impairment within the mining industry as a whole.     

Occupational exposure to ethylene oxide--OSHA. Final standard

In this Final Standard, the Occupational Safety and Health Administration (OSHA) establishes a permissible exposure limit for occupational exposure to ethylene oxide (EtO) of 1 part EtO per million parts of air (1 ppm) determined as an 8-hour time-weighted average concentration. The basis for this action is a determination by the Assistant Secretary, based on animal and human data, that exposure to EtO presents a carcinogenic, mutagenic, genotoxic, reproductive, neurologic and sensitization hazard to workers. The standard provides for, among other requirements, methods of exposure control, personal protective equipment, measurement of employee exposures, training, medical surveillance, signs and labels, regulated areas, emergency procedures and recordkeeping. An "action level" of 0.5 ppm as an 8-hour time-weighted average is established as the level above which employers must initiate certain compliance activities such as periodic employee exposure monitoring and medical surveillance. In instances where the employer can demonstrate that employee exposures are below the action level, the employer is not obligated to comply with most of the requirements set forth in this final rule. The 1 ppm 8-hour limit reduces significant risk from exposure to EtO and is considered by OSHA to be the lowest levels feasible.     

Occupational exposure to formaldehyde--OSHA. Response to Court remand; final rule

By this action, the Occupational Safety and Health Administration (OSHA) hereby amends its existing regulation for occupational exposure to formaldehyde, 29 CFR 1910.1048, in response primarily to a remand by the U.S. Court of Appeals for the D.C. Circuit in UAW v. Pendergrass, 878 F.2d 389 (D.C. Cir. 1989). The final amendments lower the permissible exposure level for formaldehyde from 1 ppm (part per million) as an 8-hour time-weighted average (TWA) to an 8-hour time-weighted average of 0.75 ppm. The amendments also add medical removal protection provisions to supplement the existing medical surveillance requirements for those employees suffering significant eye, nose or throat irritation and for those suffering from dermal irritation or sensitization from occupational exposure to formaldehyde. In addition, certain changes have been made to the standard's hazard communication and employee training requirements. These amendments establish specific hazard labeling requirements for all forms of formaldehyde, including mixtures and solutions composed of 0.1% or greater of formaldehyde in excess of 0.1 ppm. Additional hazard labeling, including a warning that formaldehyde presents a potential cancer hazard, is required where formaldehyde levels, under reasonably foreseeable conditions of use, may potentially exceed 0.5 ppm. The final amendments also provide for annual training of all employees exposed to formaldehyde at levels of 0.1 ppm or higher.     

Occupational exposure to bloodborne pathogens; approval of information collection requirements--OSHA. Final rule; approval of information collection requirements

On December 6, 1991, OSHA published a final standard governing occupational exposure to bloodborne pathogens (56 FR 64004). The standard is designed to eliminate or minimize occupational exposure to Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV) and other bloodborne pathogens. At that time OSHA submitted the information collection requirements to the Office of Management and Budget (OMB) for review under section 3504(h) of the Paperwork Reduction Act (PRA) of 1980. Public reporting burden for this collection of information was estimated to average five minutes per employer response to an OSHA compliance officer's request for access to the employer's records. OMB reviewed the collection of information requirements for occupational exposure to bloodborne pathogens in accordance with the PRA, 44 U.S.C. 3501 et seq., and 5 CFR part 1320. OMB approved all information requirements contained in 29 CFR 1910.1030 under OMB clearance number 1218-0180. The OMB clearance expires on February 28, 1995. This document will also amend the December 6, 1991 rule to properly display the OMB control number.     

Occupational exposure to bloodborne pathogens: request for information--OSHA. Request for information

OSHA requests information and comment on engineering and work practice controls used to eliminate or minimize the risk of exposure to bloodborne pathogens due to percutaneous injuries from contaminated needles and o ther contaminated sharps in occupational environments. Percutaneous injuries continue to be a concern in work settings where employees are exposed to bloodborne pathogens. The Agency is considering possible actions that it can undertake to assist in addressing this issue. Consequently, OSHA is interested in strategies for reducing percutaneous injury rates that have been successfully implemented in the work environment, including work practices and, in particular, the use of devices designed to limit the risk of such injuries. The information received in response to this notice will be carefully reviewed and will assist OSHA in determining effective approaches to reducing percutaneous injury rates and what role the Agency may have in these approaches.     

Occupational Safety and Health Administration--Access to employee exposure and medical records. Final rule

This final occupational safety and health standard, promulgated today as a revised 29 CFR 1910.20, provides for employee, designated representative, and OSHA access to employer-maintained exposure and medical records relevant to employees exposed to toxic substances and harmful physical agents. Access is also assured to employer analyses using exposure and medical records. The final standard requires long term preservation of these records, contains provisions concerning informing employees of their rights under the standard, and includes provisions protective of trade secret information.     

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.     

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 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.     

Approval tests and standards for closed-circuit escape respirators. Final rule

This final rule announces updated requirements that the National Institute for Occupational Safety and Health (NIOSH or Agency), located within the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS or Department), will employ to test and approve closed-circuit respirators used for escaping atmospheres considered to be immediately dangerous to life and health, including such respirators required by the Mine Safety and Health Administration (MSHA) for use in underground coal mines. NIOSH and MSHA jointly review and approve this type of respirator used for mine emergencies under regulations concerning approval of respiratory protective devices. NIOSH also approves these respirators for use in other work environments where escape equipment may be provided to workers, such as on vessels operated by U.S. Navy and Coast Guard personnel. The purpose of these updated requirements is to enable NIOSH and MSHA to more effectively ensure the performance, reliability, and safety of CCERs.     

Risk factors for potential occupational exposure to HIV: A study of correctional officers

This study examined social determinants that explain correctional officer exposure to blood/bodily fluids. Seasoned officers in five prisons were selected at random to complete an anonymous mail survey regarding situations which may have placed them at risk for exposure to HIV while at work. Institutional variables more strongly predicted officer chances of occupational exposure in a corrections setting than did perceptual and individual level variables, particularly the custody level of inmates supervised, length of time in the corrections career, and being in a position of rank. Years of experience increased the number of exposures to blood and bodily fluid, and increased officer apprehensiveness concerning uses of force with seropositive inmates. Knowledge about HIV and the frequency of use of personal protective equipment was not related to the likelihood of encounters with blood or bodily fluids.     

Medicare program: request for public comments on implementation of the Medicare+Choice program, and notice of timeframes for submission of applications for contracts--HCFA. Notice of intent to regulate; solicitation of comments

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice program. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plans that contract with us. The BBA directs the Secretary to publish by June 1, 1998, regulations establishing standards for the Medicare+Choice program. We have already received comments and inquiries from the public on a number of issues associated with the Medicare+Choice program. This document solicits further public comments on issues related to implementation of the Medicare+Choice program. We intend to consider these comments as we develop an interim final rule to implement the Medicare+Choice program. This document also includes preliminary information regarding application procedures for organizations that intend to contract with us to participate in the Medicare+Choice program. This document also informs the public of a meeting to discuss the Medicare+Choice program.     

Evaluation of different sampling media for their potential use as a combined swab for the collection of both organic and inorganic explosive residues

Commercially available skin cleansing alcohol wipes and conventional swabs were investigated for their use as a universal sampling medium for the simultaneous collection of both organic and inorganic explosive residues. Six compounds with the potential to be encountered in casework [pentaerythritol tetranitrate (PETN), 2,4,6-trinitrotoluene (TNT), hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX), triacetone triperoxide (TATP), ammonium nitrate, and sodium chlorate] were selected as representative target compounds. Quantities of these target compounds were deposited on four different substrates (glass, plastic, aluminium foil and laminate). Two chosen alcohol wipes demonstrated better overall performance in the recovery of both the organic and inorganic representative compounds from each of the test surfaces compared to the results obtained using conventional cotton and polyester swabs, pre-moistened with various solvents, and a direct methanol wash (used as a control). Results obtained using dry cotton swabs indicated that it was not an effective swabbing system for the collection of both organic and inorganic explosive residues on common substrates.     

Establishment, maintenance, and availability of records: amendment to record availability requirements. Interim final rule; request for comments

The Food and Drug Administration (FDA) is amending its regulations on establishment, maintenance, and availability of records. FDA is issuing this interim final rule (IFR) to amend FDA's regulation on the record availability requirements to implement the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by the FDA Food Safety Modernization Act (FSMA). The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary of Health and Human Services (the Secretary) reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This expanded records access authority will further help improve FDA's ability to respond to, and further contain threats of serious adverse health consequences or death to humans or animals.     

Medical devices; general hospital and personal use devices; classification of implantable radiofrequency transponder system for patient identification and health information. Final rule

The Food and Drug Administration (FDA) is classifying the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.     

Occupational exposure to bloodborne pathogens; needlestick and other sharps injuries; final rule. Occupational Safety and Health Administration (OSHA), Department of Labor. Final rule; request for comment on the Information Collection (Paperwork) Requirements

The Occupational Safety and Health Administration is revising the Bloodborne Pathogens standard in conformance with the requirements of the Needlestick Safety and Prevention Act. This Act directs OSHA to revise the Bloodborne Pathogens standard to include new examples in the definition of engineering controls along with two new definitions; to require that Exposure Control Plans reflect how employers implement new developments in control technology; to require employers to solicit input from employees responsible for direct patient care in the identification, evaluation, and selection of engineering and work practice controls; and to require certain employers to establish and maintain a log of percutaneous injuries from contaminated sharps.     

Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Direct final rule

The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly. We are using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. In the proposed rule section of this issue of the Federal Register, we are concurrently proposing and soliciting comments on this rule. If significant adverse comments are received, we will withdraw this final rule and address the comments in a subsequent final rule. FDA will not provide additional opportunity for comment.