Protection of human research subjects. Department of Health and Human Services (DHHS). Final rule

The Department of Health and Human Services (DHHS) is amending its human subjects protection regulations. These regulations provide additional protections for pregnant women and human fetuses involved in research and pertains to human in vitro fertilization. The rule continues the special protections for pregnant women and human fetuses that have existed since 1975. The rule enhances the opportunity for participation of pregnant women in research by promoting a policy of presumed inclusion, by permitting the pregnant woman to be the sole decision maker with regard to her participation in research, and by exempting from the regulations six categories of research. The rule also provides a mechanism for the Secretary of HHS to conduct or fund research not otherwise approvable after consultation with an expert panel and public review and comment.     

Hazardous waste management system; standards applicable to generators of hazardous waste; state program requirements. Environmental Protection Agency. Final rule

On February 26, 1980 and May 19, 1980, under the Resource Conservation and Recovery Act (RCRA), the Environmental Protection Agency (EPA) published regulations establishing a system to manage hazardous waste. Those regulations allowed hazardous waste generators to accumulate hazardous waste on-site without obtaining a permit or meeting financial responsibility requirements if they shipped the waste off-site within 90 days. On November 19, 1980, the Agency published an interim final rule which expanded the scope of the provision to include generators who treat, store or dispose of hazardous waste on-site. The final rule published today retains this change. As a result of public comments, the Agency is making several changes to the interim final rule. These changes (1) Clarify that the provision is applicable to all generators, including those who accumulate hazardous waste for the purpose of use, reuse, recycling and reclamation, (2) remove the requirement for use of DOT containers, (3) revise the labelling and marking requirements for wastes accumulated in containers and tanks; and (4) allow an extension to the 90-day accumulation limit in certain circumstances.     

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.     

Acid Rain Program: general provisions and permits, allowance system, continuous emissions monitoring, excess emissions and administrative appeals--EPA. Final rule

Title IV of the Clean Air Act (the Act), as amended November 15, 1990, requires the Environmental Protection Agency (EPA or Agency) to establish an Acid Rain Program to reduce the adverse effects of acidic deposition. To implement this statutory mandate, the Acid Rain Program requirements will be codified in seven regulations. This action delineates all or portions of five final regulations that were initially proposed December 3, 1991: General Provisions and Permits; the Allowance System; Continuous Emissions Monitoring; Excess Emissions Penalties; and Administrative Appeals. (The administrative appeals procedures were originally proposed as a subpart of the permits rule; EPA has decided to remove it from part 72 and place it in a separate part 78.) In addition to the final rules, this action includes a brief overview of the acid rain problem, summaries of major provisions of the proposed rules, the public's comments on these proposals, and summaries of the major changes that have been made in this final rule. DATES: These rules become effective February 10, 1993. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of February 10, 1993.     

Medicare and Medicaid programs; approved information collection requirements--HCFA. Final rule with comment period

This final rule updates our display of approved control numbers for the collection of information that have been assigned to HCFA by the Office of Management and Budget (OMB). OMB regulations require each agency to include the approval numbers in the agency's rules.     

Treatment of research-related injuries to human subjects--VA. Final rule

This final rule amends the Department of Veterans Affairs (VA) medical regulations to provide (or to pay for the provision of) necessary medical treatment to certain human subjects injured as a result of participation in VA research. Under the final rule all participants in research approved by a VA Research and Development Committee (regardless of source of funding), and conducted under the supervision of one or more VA employees, are eligible for treatment unless injuries are due to noncompliance by a research subject with study procedures. VA will provide medical care in those circumstances where VA has some responsibility for the need for medical care.     

Interim status standards for owners and operators of hazardous waste treatment, storage, and disposal facilities--Environmental Protection Agency. Interim final rule and interim final amendments to rules and request for comments

The Environmental Protection Agency [EPA] has issued standards applicable to owners and operators of hazardous waste management facilities as required by the Resource Conservation and Recovery Act [RCRA]. One of these standards bans the disposal of most containerized liquid hazardous waste in landfills, effective November 19, 1981. As a result of reconsideration of this restriction, EPA is today promulgating an interim final rule to allow the disposal of small containers of liquid and solid hazardous waste in landfills provided that the wastes are placed in overpacked drums [lab packs] in the manner specified in today's rule. The purpose of today's rule is to provide an environmental sound disposal option for generators of small containers of hazardous wastes, such as laboratories.     

Regulatory Science and the Data Quality Act

The importance of data quality was highlighted in an amendment attached to a 2000 law enacted by the 106th U.S. Congress. The law known as the “Data Quality Act” or the “Information Quality Act,” mandated that the Office of Management and Budget (OMB) issue guidance to federal agencies for “ensuring and maximizing the quality, objectivity, utilility, and integrity of information (including statistical information) disseminated by federal agencies.” In turn, OMB required more than 90 federal agencies such as the United States Environmental Protection Agency (EPA) to implement data quality guidelines. These guidelines have created a rigorous, if not rancorous, debate within the regulated community. This paper will provide a brief synopsis of the evolution of the Act, discuss how the Act and scientific uncertainty interrelate, and review the status of the Act's petition process for correcting government disseminated information.     

Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals, other non-profit, and commercial organizations--Department of Commerce. Interim final rule

This interim final rule implements the revisions to the Office of Management and Budget (OMB) Circular A-110, "Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations" which was published in the Federal Register on November 29, 1993. The revised Circular was developed by an interagency task force for governmentwide use in a model rule format to facilitate regulatory adoption by executive departments and agencies. In the published revised Circular, OMB specified as "required action" that Federal agencies responsible for awarding and administering grants and other agreements to recipients described therein, shall adopt the language of the Circular unless other provisions are required by Federal statute or exceptions or deviations are approved by OMB. This interim final rule adopts the provisions of the Circular and its language to the maximum extent feasible. However, minor changes were made to update the procedures, clarify the language, and make the language apply specifically to the DoC and its operating units. No changes are intended to deviate from the substance of Circular A-110. The Circular covers both grants and cooperative agreements made by Federal agencies and subawards, unless sections of the Circular specifically exclude subrecipients from coverage. Consistent with guidance provided in the Circular, DoC will apply its provisions to grants and agreements with institutions of higher education, hospitals, other nonprofit, and commercial organizations. The provisions of the interim final rule will also apply to foreign governments, organizations under the jurisdiction of foreign governments, and international organizations when appropriate.     

Research ethics across the 49th parallel: the potential value of pilot testing "equivalent protections" in Canadian research institutions

Canada and the United States share the world's largest trade partnership and an increasing concern about divergent regulatory approaches to common industries. Canadian research institutes receive more research funding from the U.S. National Institutes of Health than any other country, much of it to fund multi-centre and collaborative research between the two countries. Because of these close economic and research ties, and the extensive similarities between the two countries in the review and oversight of ethics in human subjects research, we propose that Canada would be an ideal country for a pilot-test of the feasibility of "equivalent protections," a U.S. regulation that permits comparison of protections for human subjects between institutions in the two countries. The "equivalent protections" has been advocated by various bodies in the United States as a potentially beneficial mechanism for improving oversight of foreign trials. As well, we argue that "equivalent protections" could prove to be valuable for Canada in five specific ways: (1) by potentially reducing administrative burden on Canadian research institutions administering U.S. federal research funding; (2) by creating symbolic value of an explicit recognition by the United States that procedures normally followed for the protection of human subjects in Canadian research institutions are at least equivalent to those provided by the U.S. regulations; (3) by lowering the opportunity cost of investing in research in Canada; (4) by affording Canada an opportunity to enhance its leadership role in international research by offering an alternative to the U.S. regulatory model for the protection of human subjects; and (5) by providing a model for how the idea of equivalent protections might be addressed for research funded by Canadian agencies but conducted in other countries.     

Medical devices; reports of corrections and removals; lift of stay of effective date--FDA. Final rule; lift of stay of effective date

The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on establishing procedures for submission of reports of corrections and removals of medical devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule.     

Regulation for the enforcement of federal health care provider conscience protection laws. Final rule

The Department of Health and Human Services issues this final rule which provides that enforcement of the federal statutory health care provider conscience protections will be handled by the Department's Office for Civil Rights, in conjunction with the Department's funding components. This Final Rule rescinds, in part, and revises, the December 19, 2008 Final Rule entitled "Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law" (the "2008 Final Rule"). Neither the 2008 final rule, nor this final rule, alters the statutory protections for individuals and health care entities under the federal health care provider conscience protection statutes, including the Church Amendments, Section 245 of the Public Health Service Act, and the Weldon Amendment. These federal statutory health care provider conscience protections remain in effect.     

Medicare and Medicaid programs; approved information collection requirements and HCFA's claims collection authority--HCFA. Final rule with comment period

This final rule updates our display of control numbers assigned by the Office of Management and Budget (OMB) to approved "collection of information" requirements contained in regulations governing the Medicare and Medicaid programs. In addition, it incorporates a technical change to our regulations to reflect increased agency authority under the Federal Claims Collection Act, 31 U.S.C. 3711 et seq. This rule is issued in accordance with OMB regulations concerning approved collections of information and to conform to changes made by Public Law 101-552.     

Revised standards for protection against radiation; minor amendments--NRC. Final rule: minor corrective and conforming amendments

This final rule makes a number of minor corrective and conforming amendments to the NRC's revised standards for protection against radiation. The final rule is necessary to correct recently discovered errors in the text of the revised standards, to conform portions of regulatory text to the Commission's decision to defer mandatory implementation of the revised standards until 1994, and to reflect the recent OMB approval of the use of NRC Forms 4 and 5.     

Miscellaneous amendments--HHS. Final rule

This final rule will remove appendixes I and J, which contain the test of Office Management and Budget (OMB) Circulars A-128 and A-133, from 45 CFR part 74. It will also update several items to conform them to the Federal Acquisition Streamlining Act of 1994 and correct a confusing statement which resulted from two typographical errors in that portion of OMB Circular A-110 upon which this statement is based.     

Burning of hazardous waste in boilers and industrial furnaces--EPA. Final rule: corrections; technical amendments

On February 21, 1991, the Environmental Protection Agency (EPA) published a final rule to regulate air emissions from the burning of hazardous waste in boilers and industrial furnaces (56 FR 7134). Today's notice corrects typographical and editorial errors that appeared in the regulatory text, including corrections to appendices II and III, and adds two appendices, appendix IX and appendix X, to part 266. Appendices IX and X were not ready at the time of publication; therefore, a note was placed in the appropriate location in the rule to inform readers that these appendices were to be published at a later date. Copies of these appendices were, however, made available to the public through the RCRA Docket maintained at EPA and through the National Technical Information Service (NTIS).     

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.     

Audit requirements for institutions of higher education and other nonprofit organizations--Department of Commerce. Interim final rule with request for comments

The Department of Commerce is implementing Office of Management and Budget (OMB) guidance provided in Circular A-133, "Audits of Institutions of Higher Education and Other Nonprofit Organizations." As a result of this interim final rule, institutions of higher education and other nonprofit organizations that receive Federal assistance are required to periodically perform audits and submit the audit reports to the Federal government. This interim final rule establishes uniform audit requirements applicable to these organizations and defines the Department's responsibilities for implementing and monitoring these requirements.     

Cost allocation methodology applicable to the temporary assistance for needy families program. Final rule

This final rule applies to the Temporary Assistance for Needy Families (TANF) program and requires States, the District of Columbia and the Territories (hereinafter referred to as the "States") to use the "benefiting program" cost allocation methodology in U.S. Office of Management and Budget (OMB) Circular A-87 (2 CFR part 225). It is the judgment and determination of HHS/ACF that the "benefiting program" cost allocation methodology is the appropriate methodology for the proper use of Federal TANF funds. The Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996 gave federally-recognized Tribes the opportunity to operate their own Tribal TANF programs. Federally-recognized Indian tribes operating approved Tribal TANF programs have always followed the "benefiting program" cost allocation methodology in accordance with OMB Circular A-87 (2 CFR part 225) and the applicable regulatory provisions at 45 CFR 286.45(c) and (d). This final rule contains no substantive changes to the proposed rule published on September 27, 2006.     

Of Rights and Rhetoric: Discourses of Degradation and Exploitation in the Context of Sex Trafficking

International condemnations of people trafficking (particularly of women and girls for prostitution) as a human rights violation have proliferated in recent times. The deployment of human rights in this context has been supported by those who seek to challenge narrow victim hierarchies, but these accounts fail to clearly articulate which particular aspects of the activity violate which particular rights, and how. This article examines the applicability of protections against slavery and inhuman/degrading treatment, arguing that, in the context of the diversity and complexity of contemporary people trafficking, their limitations become apparent. The final part considers the concept of exploitation as an alternative basis for grounding a human rights claim. It cautions that invoking this concept without further elaboration (particularly in relation to the relevance of harm and consent) may be counter-productive, both in terms of theoretical clarity and practical implementation.