Medicare, Medicaid and CLIA programs; revision of the laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs--HCFA. Final rule with comment period

This rule revises regulations for laboratories regulated under the Medicare, Medicaid and Clinical Laboratories Improvement Act of 1967 (CLIA '67) programs. The revisions recodify the regulations for these programs into a new part 493 in order to simplify administration and unify the health and safety requirements for all programs as much as possible. We will now have a single set of regulations for the three programs, with an additional subpart for the licensure procedures unique to the CLIA program. We are revising the regulations to remove outdated, obsolete and redundant requirements, make provision for new technologies and place increased reliance on outcome measures of performance. We provide for new uniform proficiency testing standards. We have also added requirements for additional specialties, such as clinical cytogenetics. We also implement the now and self-implementing provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88).     

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.     

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.     

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.     

Revisions to the requirements applicable to blood, blood components, and source plasma; confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment

The Food and Drug Administration (FDA) is confirming in part the direct final rule issued in the Federal Register of August 19, 1999. 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. FDA is confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is amending Title 21 Code of Federal Regulations to reinstate the former provisions.     

Standards applicable to owners and operators of hazardous waste treatment, storage, and disposal facilities: liability requirements. Environmental Protection Agency. Revised interim final rule

The Environmental Protection Agency is today revising regulations of January 12, 1981, on liability coverage requirements for hazardous waste facility owners or operators. Under these requirements, owners or operators must demonstrate liability coverage for bodily injury and property damage to third parties resulting from facility operations. The major revisions are: addition of the option of a financial test as a means of demonstrating liability coverage to satisfy the requirements; addition of the option of submitting a certificate of insurance as evidence of insurance; and changes in the requirements for the endorsement and certificate. In a future document, EPA will propose to delete two provisions of the January 12, 1981 regulations. These provisions are: the procedure to obtain a variance for liability coverage requirements; and the provision allowing an owner or operator to use State assumption of legal responsibility for liability coverage to satisfy the liability requirements. The January 12, 1981, regulations were issued under an accelerated schedule imposed by a court order. The revisions that are being made today are necessary to eliminate unworkable aspects of the previous regulations, improve their effectiveness, and allow reasonable flexibility in satisfying the requirements.     

Standards for privacy of individually identifiable health information. Final rule

The Department of Health and Human Services ("HHS' or "Department') modifies certain standards in the Rule entitled "Standards for Privacy of Individually Identifiable Health Information' ("Privacy Rule'). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996. The purpose of these modifications is to maintain strong protections for the privacy of individually identifiable health information while clarifying certain of the Privacy Rule's provisions, addressing the unintended negative effects of the Privacy Rule on health care quality or access to health care, and relieving unintended administrative burdens created by the Privacy Rule.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human); confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment

The Food and Drug Administration (FDA) is confirming in part the direct final rule that appeared in the Federal Register of May 14, 1999 (64 FR 26282). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is hereby amending Title 21 Code of Federal Regulations to reinstate the former provisions. In addition, FDA is correcting the precision of the value for protein concentration that was inadvertently omitted from the codified section of the direct final rule.     

Updating OSHA standards based on national consensus standards. final rule; confirmation of effective date

OSHA is confirming the effective date of its direct final rule that revises a number of standards for general industry that refer to national consensus standards. The direct final rule states that it would become effective on March 13, 2008 unless OSHA receives significant adverse comment on these revisions by January 14, 2008. OSHA received no adverse comments by that date and, therefore, is confirming that the rule will become effective on March 13, 2008.     

The hazardous waste management system--Environmental Protection Agency. Interim final amendments to interim final and final rules

The Resource Conservation and Recovery Act (RCRA) requires that EPA set regulatory standards for all facilities which treat, store, or dispose of hazardous waste. In partial implementation of its requirement, on January 23, 1981, EPA set regulatory standards for incinerators that burn hazardous waste. These regulations were issued as "interim final," which means that, although they were issued in final form, the Agency invited public comment on them with a view to future amendment. Today, EPA is amending, on an interim final basis, certain of its regulations applicable to hazardous waste incineration facilities. Today's amendments include revisions to: the general standards for permitting hazardous waste incinerators (Part 264, Subpart O), published in the Federal Register on January 23, 1981; the interim status standards for hazardous waste incinerators (Part 265, Subpart O), revised on January 23, 1981; and the consolidated permit requirements for incinerators (Part 122), published on May 19, 1980 and January 23, 1981.U     

Health maintenance organizations; amendments of 1981--Health Resources and Services Administration. Notice of proposed rulemaking

This notice proposes to amend the Public Health Service rules on health maintenance organizations (HMOs) to conform with the 1981 amendments to the HMO statute regarding member protection in the event of insolvency, community rating by class, and primary care within the service area of a non-metropolitan HMO. In addition, this notice proposes: (a) to remove provisions of the rules that are considered unnecessary or burdensome, such as the regulatory specification of contractual provisions, and (b) to increase one of the regulatory limits on copayments to permit HMOs to become more competitive with alternative forms of health insurance.     

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").     

Revisions to the requirements applicable to blood, blood components and source plasma. Direct final rule

The Food and Drug Administration (FDA) is amending 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. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.     

Dealing with a changed regulatory climate: OSHA under the Auchter administration

Traditionally, the relationship between OSHA and the employer faced with an OSHA inspection has been an adversarial one. Employers have tended to perceive OSHA inspectors as nitpicking and antagonistic rather than helpful in performing their functions as agents monitoring occupational safety and health in the work place. With the appointment of Thorne Auchter as assistant secretary of labor for occupational safety and health, however, the climate for cooperation between employers and OSHA has substantially improved. Auchter has taken steps to improve the image of the Agency and its inspectors while at the same time correcting federal overregulation of the work place. In the following article, the author outlines the changes Auchter has brought to OSHA in his efforts at redirecting the Agency's operations. He also provides a step-by-step guide for employers to follow during an OSHA inspection.     

Over-the-counter human drugs; labeling requirements; final rule; technical amendment. Food and Drug Administration, HHS. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the regulation that established a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products, and is amending several related OTC drug product labeling regulations. This amendment corrects and conforms several aspects of the new labeling requirements to other regulatory provisions and eliminates unnecessary text from the new labeling regulation.     

Health maintenance organizations--PHS. Final rule

This rule amends the Public Health Service regulations on health maintenance organizations (HMOs) to elaborate on the 1981 amendments to the HMO statute regarding member protection in the event of insolvency, community rating by class, and primary care within the service area of a non-metropolitan HMO. In addition, the rule removes regulatory provisions that are considered unnecessary or burdensome, such as the specification of contractual provisions, and increases one of the regulatory limits on copayments to permit HMOs to become more competitive. These amendments are made after consideration of public comments on the notice of proposed rulemaking (NPRM) published on March 22, 1983.     

Gaps, inexperience, inconsistencies, and overlaps: crisis in the regulation of genetically modified plants and animals

The regulation of genetically modified products pursuant to statutes enacted decades prior to the advent of biotechnology has created a regulatory system that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured and inefficient--transgenic plants and animals are governed by at least twelve different statutes and five different agencies or services. The deficiencies resulting from this piecemeal approach to regulation unnecessarily expose society and the environment to adverse risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary increases in the cost of and delay in the development and commercialization of new biotechnology products. These deficiencies also increase the risk of further unnecessary biotechnology scares, which may cause public overreaction against biotechnology products, preventing the maximization of social welfare. With science and society poised to soar from first-generation biotechnology (focused on crops modified for agricultural benefit), to next-generation developments (including transgenic fish, insects, and livestock, and pharmaceutical-producing and industrial compound-producing plants and animals), it is necessary to establish a comprehensive, efficient, and scientifically rigorous regulatory system. This Article details how to achieve such a result through fixing the deficiencies in, and risks created by, the current regulatory structure. Ignoring many details, the solutions can be summarized in two categories. First, statutory and regulatory gaps that are identified must be closed with new legislation and regulation. Second, regulation of genetically modified products must be shifted from a haphazard model based on statutes not intended to cover biotechnology to a system based upon agency expertise in handling particular types of risks.     

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.