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 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.     

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 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 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.     

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.     

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.     

National Institute for Occupational Safety and Health; occupational exposure to inorganic lead: request for comments and information; republication--NIOSH. Request for comments and information relevant to occupational exposure to inorganic lead

NIOSH is reviewing its recommendations contained in the document Criteria for a Recommended Standard.... Occupational Exposure to Inorganic Lead, Revised Criteria--1978 [NIOSH 1978]. The evaluation of recent literature indicates that the NIOSH recommended exposure limit [REL] of 100 micrograms/m3 as an 8-hour time-weighted average [TWA] in that document does not sufficiently protect workers from the adverse effects of exposure to inorganic lead. NIOSH is requesting comments and information relevant to the evaluation of the potential health risks associated with occupational exposure to inorganic lead, as well as case reports or other data that demonstrate adverse health effects in workers exposed to inorganic lead at or below the OSHA permissible exposure limit [PEL] of 50 micrograms/m3 as an 8-hour TWA and any information pertinent to evaluating the technical feasibility of establishing a more protective REL for inorganic lead. NIOSH is also soliciting information on worker blood lead levels [BLLs] including data on methodologies used in measuring BLLs in the workplace and information that can be used for comparing airborne inorganic lead concentrations to observed BLLs. NIOSH intends to analyze the feasibility of developing preventive measures including an REL that would provide better protection for workers. In the interim, NIOSH plans to adopt the more protective current OSHA PEL as its REL.     

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.     

Technical revisions to conform to the Caregivers and Veterans Omnibus Health Services Act of 2010. Final rule

This final rule amends Department of Veterans Affairs (VA) medical regulations to incorporate statutory amendments. Certain statutes authorizing VA health care benefits were amended by the Caregivers and Veterans Omnibus Health Services Act of 2010. The statutory amendments affect enrollment in certain health care priority categories and exempt catastrophically disabled veterans from copayment requirements.     

Evaluating the Potential for Unintentional Occupational Exposure to Fentanyl and Fentanyl Analogues Among Medicolegal Death Investigators and Autopsy Technicians

Recent increases in deaths in the United States from synthetic opioids such as fentanyl and fentanyl analogues (fentanyls) have raised concerns about possible occupational exposures to these potent agents. Medicolegal death investigators and autopsy suite staff might perform job tasks involving exposure to fentanyls. The potential for exposure to fentanyls among medicolegal death investigators and autopsy technicians at a state medical examiner's office was evaluated through review of caseload characteristics, injury and illness logs, and procedures and policies and discussions with management and employee representatives. The evaluation showed that this medical examiner's office had low potential for work-related exposure to fentanyls; its standard operating procedures and personal protective equipment requirements should reduce the potential for occupational exposure. Medicolegal death investigation agencies can develop and implement guidance to control exposures and provide workforce education and training to reduce the potential for work-related exposure to fentanyls.     

Medicolegal death investigator workplace safety hazards: A scoping review of the literature

In the United States, medicolegal death investigation practices and policies pertaining to sudden unexpected deaths are mandated by state government. Practices vary across states, which contributes to inconsistency in job prerequisites and training. In preparation for a study focused on occupational safety and health of medicolegal death investigators in their on-scene and follow-up activities, a scoping review was conducted to document known occupational safety risks and health-related conditions associated with death investigation. Searches used Boolean and subject heading operators both broad and narrow in scope, and search terms included scene responder, hazard, investigator, forensic pathology, injury, and safety. Twenty-five articles met inclusion criteria, which included seventeen survey-mixed method designs, two systematic reviews, five quasi-experimental designs, and one case study. Twelve articles addressed mental health and eleven focused on risks associated with infectious disease. One article addressed the risk of chemical exposure from cyanide among autopsy personnel (including forensic pathologists) and nine included a wide range of employees within the setting of medical examiner or coroner offices. One article, addressing burnout, included employees in a forensic science laboratory setting as well as medicolegal death investigators and two articles included forensic pathologists and medicolegal death investigators. Only one article addressed medicolegal death investigators specifically. Articles addressing occupational and environmental hazards of medicolegal death investigators associated with musculoskeletal, respiratory, cardiovascular, radiological, nuclear, electrical, or explosive threats were not identified. There is little published about safety risks inherent in conducting death investigations. Research is needed to adequately inform health promotion and injury prevention strategies.     

Minor corrections, clarifying changes, and a minor policy change--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations to make minor corrections and clarifying changes to the NRC's 10 CFR Part 20, "Standards for Protection Against Radiation." The final rule is also intended to conform other regulations with the Commission's 1991 revised radiation protection requirements. In addition, the final rule includes a minor policy change that raises the monitoring criteria for minors from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared pregnant women from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) during their pregnancies. The 0.1 rem (1 mSv) in a year deep dose equivalent monitoring criterion is consistent with the public dose limit and represents a quantity more consistent with the measurement sensitivity of individual personnel dosimetry. Licensees are still required to ensure that the occupational dose limit of 0.5 rem (5 mSv) in a year is not exceeded for minors, that the dose limit of 0.5 rem (5 mSv) to an embryo/fetus due to occupational exposure of a declared pregnant woman is not exceeded during the course of the pregnancy, and that sufficient effort is made to ensure that substantial variations above a uniform monthly exposure rate for a declared pregnant woman are avoided. These changes to the threshold for monitoring exposures to radiation and radioactive material to demonstrate compliance with the limits do not change the occupational dose limits for minors or declared pregnant workers.     

Reporting by multiple employer welfare arrangements and certain other entities that offer or provide coverage for medical care to the employees of two or more employers. Final rule

This document contains a final rule governing certain reporting requirements under Title I of the Employee Retirement Income Security Act of 1974 (ERISA) for multiple employer welfare arrangements (MEWAs) and certain other entities that offer or provide coverage for medical care to the employees of two or more employers. The final rule generally requires the administrator of a MEWA, and certain other entities, to file a form with the Secretary of Labor for the purpose of determining whether the requirements of certain recent health care laws are being met.     

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.     

Exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile. Final rule

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the interim final rule that issued regulations permitting FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). FDA is taking this action to complete the rulemaking initiated with the interim final rule.     

Container and waste pile standards for owners and operators of hazardous waste facilities: consolidated permit regulations--Environmental Protection Agency. Amendments to interim final rule

The Environmental Protection Agency (EPA) is today promulgating amendments to the hazardous waste management regulations regarding the management of hazardous waste in containers and piles and associated permit regulations (40 CFR Part 264, Subparts I and L, and Part 122, Subpart B). These amendments better tailor the standards to the particular type of hazard posed by specific situations. The standards for containers are amended to waive the containment system requirements for wastes that do not contain free liquids, provided that the wastes are protected from contact with accumulated liquid. The standards for waste piles are amended to waive the containment system requirements for wastes that do not contain free liquids, provided that the pile is protected from precipitation by a structure and from surface water run-on and wind dispersal of the waste by the structure or some other means. The Agency believes these amendments believes these amendments will not reduce the level of protection of human health and the environment.     

Natural rubber-containing medical devices; user labelling--FDA. Final rule; interpretation

The Food and Drug Administration (FDA) is providing notice that it does not intend to apply to combination products currently regulated under human drug or biologic labeling provisions its September 30, 1997, final rule requiring certain labeling statements for all medical devices that contain or have packaging that contains natural rubber that contacts humans. FDA is taking this action, in part, in response to a citizen petition and other communications from industry that the agency has received since the publication of the final rule. FDA intends to initiate a proceeding to propose natural rubber labeling requirements for drugs and biologics, including combination products that are currently regulated under drug and biologic labeling provisions. Such a proceeding may include a combination of rulemaking and guidance and will offer opportunity for public comment.     

Amendment to the current good manufacturing practice regulations for finished pharmaceuticals. Direct final rule

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual notice-and-comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.     

Revisions to the requirements applicable to blood, blood components and source plasma; confirmation of effective date and technical amendment. Direct final rule; confirmation of effective date and technical amendment

The Food and Drug Administration (FDA) is confirming the effective date of February 19, 2008, for the direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. In addition, FDA is making technical amendments to the biologics regulations in response to comments received on the direct final rule.