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 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 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.     

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 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.     

Ethylene oxide; certain pesticide products registered for the sterilization of equipment and supplies in hospitals and health care facilities; withdrawal of revised labeling notice--EPA. Withdrawal of notice

EPA issued a notice requesting registrants of pesticide products containing ethylene oxide (EtO) registered for certain uses in hospitals and health care facilities to submit applications to amend approved labeling. Elsewhere in this issue of the Federal Register, the Occupational Safety and Health Administration (OSHA) has promulgated comprehensive exposure standards for all occupational uses of EtO. Therefore, EPA has decided to withdraw the original notice in recognition of concerns regarding the potential preemption of the OSHA standards.     

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--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.     

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.     

Updating OSHA standards based on national consensus standards. Direct final rule

In this direct final rule, the Agency is removing several references to consensus standards that have requirements that duplicate, or are comparable to, other OSHA rules; this action includes correcting a paragraph citation in one of these OSHA rules. The Agency also is removing a reference to American Welding Society standard A3.0-1969 ("Terms and Definitions") in its general-industry welding standards. This rulemaking is a continuation of OSHA's ongoing effort to update references to consensus and industry standards used throughout its rules.     

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 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.     

Oversight of Administrative Rulemaking: Judicial Review

The role of the courts in the review of administrative rulemaking raises profound questions as to the legitimate interference of courts in the exercise of administrative activities, which are often carried out in the pursuance of a legislative mandate. In contrast to the review of administrative acts of individual application, the Union courts have shown a more hesitant approach in the review of administrative rulemaking activities. This contribution will discuss the review by the Union courts of administrative rulemaking for compliance with procedural as well as substantive standards and will explore whether a convincing rationale for their more deferential attitude to the review of administrative rules can be provided. The article will explore to what extent lessons can be learned from the jurisprudence of the federal courts in the USA, which have struggled, even after the adoption of the Administrative Procedure Act (APA), with similar problems.     

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.     

Child abuse and neglect prevention and treatment program--HHS. Notice of proposed rulemaking

This rule proposed changes in the regulations that implement the Child Abuse Prevention and Treatment Act. Recent amendments to this Act (Pub. L. 98-457) made changes in several definitions regarding child abuse and neglect which may require State regulatory changes. These and other proposed requirements are the subject of this notice. On December 10, 1984 (49 FR 48160), the Department published a notice of proposed rulemaking to implement the requirement for State child protective service agencies to establish programs and/or procedures for the protection and treatment of disabled infants with life-threatening conditions ("Baby Does"). These requirements were also a part of Pub. L. 98-457.     

European Agencies' Rulemaking: Powers,Procedures and Assessment

This article aims at identifying European agencies' rulemaking powers, mapping the procedures through which such powers are exercised and assessing the existing procedural arrangements. The first section analyses the main forms of European agencies' rulemaking. It shows, on the one hand, that not all European agencies are actually engaged in the adoption of administrative rules, on the other hand, that European agencies carrying out rulemaking activities tend to converge on two specific forms of rulemaking, namely participation in the adoption of binding implementing rules and regulation by soft law. The second section, devoted to mapping the procedures through which rulemaking powers are exercised, argues that the two main types of European agencies' rulemaking cannot be said to be subject to a really common procedural framework. In both cases, the emerging procedural rules implement the same principles of transparency and participation and rely on the same consultation mechanism, sometimes complemented by regulatory impact assessment. Yet, proceduralisation has an uneven development: while the establishment of a procedural discipline is quite common with reference to participation in the adoption of binding implementing rules, regulation by soft law remains largely under‐proceduralised. The last section proposes an assessment of the European agencies' rulemaking procedures. Two main shortcomings are identified: the asymmetry between the tendency to proceduralise the adoption of binding implementing rules and the parallel tendency to keep informal the process of adoption of soft law measures; and the too rudimental development of consultation.     

同行评议与发表：对法律工作者的启迪

在确定某理论或者技术是否属于科学知识，从而有助于事实审判者时，该理论或者技术是否通过了同行评议并发表是一个重要的考量因素。本文讨论了同行评议的起源、在科学和医学期刊建设中的现行角色、出版前同行评议的基本理论，以及同行评议作为质量控制机制的固有的局限性。     

Medical devices; review and revision of compliance policy guides and regulatory requirements for refurbishers, rebuilders, reconditioners, servicers and "as is" remarketers of medical devices; request for comments and information; extension of comment period--FDA. Advance notice of proposed rulemaking; extension of comment period

The Food and Drug Administration (FDA) is extending to June 29, 1998, the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of December 23, 1997 (62 FR 67011). This advance notice announced FDA's intention to review and, as needed, to revise compliance policy guides, amend regulatory requirements and, as appropriate, exercise alternative regulatory approaches regarding the remarketing of used medical devices. The agency is taking this action in response to two requests for extensions. This extension of comment period is intended to allow interested persons additional time to submit comments on the ANPRM.     

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").     

Voluntary protection programs to supplement enforcement and to provide safe and healthful working conditions--OSHA. Notice of implementation of revised voluntary protection programs

OSHA announces the implementation of three Voluntary Protection Programs. The programs, revised from the January 19, 1982, notice in the Federal Register (47 FR 2796), seek out and recognize exemplary safety and health programs as a means of expanding worker protection. Companies, general contractors, and small business organizations which meet specified programmatic safety and health criteria, which go beyond OSHA standards in providing safe and healthful workplaces for their employees, and which want to do more than is required to help the agency accomplish the goals of the Act are the applicants OSHA seeks for these voluntary programs. In return, OSHA will remove participants from general schedule inspection lists and give priority attention to any which request a variance. The programs are called "Star." "Try," and "Praise."