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January 14, 2009 Summary This report discusses the Special Inspector General provisions in the Emergency Economic Stabilization Act of 2008 (EESA), H.R. 1424, which was enacted as P.L. 110-343 on […]

January 7, 2009 Summary The Constitution of the United States of America imbues the President with broad authority to grant pardons and reprieves for offenses against the United States. This […]

The article presents a Congressional Research Service (CRS) report for the U.S. Congress on key issues in the Keystone XL pipeline project in the U.S. and Canada proposed by TransCanada in 2008. The estimated transport capacity of the pipeline is 700,000 barrels of crude oil daily. The opponents to the pipeline project are environmental groups and affected communities. Also explored is the economic impact of the Keystone XL pipeline.

The article assesses the arguments for and against the Keystone XL pipeline in the U.S. and Canada proposed by TransCanada in 2008. Canadian agencies and petroleum industry stakeholders in the countries support the project. The company claimed that the project will allow the U.S. to maintain adequate crude oil supplies for refineries. Among the environmental impacts of oil production from oil sands are emissions of greenhouse gases and impact on water quality.

An introduction to a Congressional Research Service (CRS) report for the U.S. Congress on key issues in the Keystone XL pipeline project in the U.S. and Canada proposed by TransCanada in 2008 is presented.

American consumers spend more than $1 trillion on food each year. The combined efforts of the food industry and government regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, public health officials have estimated that each year in the United States, many millions of people become sick and thousands die from foodborne illnesses caused by any of a number of microbial pathogens and other contaminants. At issue is whether food safety agencies have the resources, authority, and structural organization to safeguard the public, and whether they use resources effectively. Also at issue is whether federal food safety laws, first enacted in the early 1900s, have kept pace with the significant changes in the food production, processing, and marketing sectors since then. In the 111th Congress, comprehensive food safety legislation passed both the House (H.R. 2749) in July 2009 and the Senate (S. 510) in November 2010. Both the House and Senate bills mainly focus on the U.S. Food and Drug Administration's (FDA's) food regulation rather than that of the U.S. Department of Agriculture (USDA), which oversees most meat and poultry. The bills would generally expand or modify existing FDA authorities rather than create a new food safety structure or authorities. Future congressional action, however, remains uncertain. Following passage of the Senate-passed bill, it was reported that the House might block the Senate bill using a procedure known as "blueslipping," because the bill contains fees that might be subject to certain tax origination provisions. Food safety legislation is a response to a number of perceived problems with the current food safety system. For example, a growing consensus is that the FDA's current programs are not proactively designed to emphasize prevention, evaluate hazards, and focus inspection resources on areas of greatest risk to public health. Given its widely acknowledged funding and staffing constraints, and no explicit requirement on the frequency of inspections, the agency infrequently visits food manufacturing and other facilities to check sanitary and other conditions. Both the House and Senate bills (in different ways) would require food processing, manufacturing, shipping, and other regulated facilities to conduct an analysis of the most likely safety hazards and to design and implement risk-based controls to prevent them. The bills envision establishment of science-based "performance standards" for the most significant food contaminants. To help determine such risks and hazards, the bills propose improvement of foodborne illness surveillance systems. Both bills seek to increase frequency of inspections, tighten record-keeping requirements, extend more oversight to certain farms, and mandate product recalls if a firm fails to institute them voluntarily. Major portions of the bills are devoted to increasing the scrutiny of food imports, which account for a growing share of U.S. consumption; food import shipments would have to be accompanied by documentation that they can meet safety standards that are at least equivalent to U.S. standards. Such certifications might be provided by foreign governments or other so-called third parties accredited in advance. The House and Senate bills differ in how to accomplish these objectives. The bills have provisions for certifying or accrediting laboratories, including private laboratories, to conduct sampling and testing of food. [ABSTRACT FROM AUTHOR]

On June 11, in response to the global spread of a new strain of influenza, the World Health Organization (WHO) raised the level of influenza pandemic alert to phase 6, which indicates the start of an actual pandemic. This change reflected the spread of the new influenza A(H1N1) virus, not its severity. Although currently the pandemic is of moderate severity with the majority of patients experiencing mild symptoms and making a rapid and full recovery, this experience could change. This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues. There are a number of emergency measures which may help to contain or ameliorate an infectious disease outbreak. The Public Health Service Act, the Federal Food, Drug, and Cosmetic Act, the National Emergencies Act, and the Stafford Act contain authorities that allow the Secretary of Health and Human Services or the President to take certain actions during emergencies or disasters. While the primary authority for quarantine and isolation in the United States resides at the state level, the federal government has jurisdiction over interstate and border quarantine. The federal government also issues recommendations regarding such activities as school closures and vaccination programs. States and local governments have the authority to initiate emergency measures such as mandatory vaccination orders and certain nonpharmaceutical interventions such as school closures, which may lessen the spread of an infectious disease. The International Health Regulations adopted by the WHO in 2005 provide a framework for international cooperation against infectious disease threats. The use of these emergency measures to contain the 2009 influenza pandemic may raise a classic civil rights issue: to what extent can an individual’s liberty be curtailed to advance the common good? The U.S. Constitution and federal civil rights laws provide for individual due process and equal protection rights as well as a right to privacy, but these rights are balanced against the needs of the community. Liability issues may become particularly important during the 2009 influenza pandemic. The Public Readiness and Emergency Preparedness Act limits liability with respect to the use of countermeasures for pandemic flu or other public health threats. A patchwork of federal and state laws generally protect volunteers, which may include volunteer health professionals (VHPs), under certain circumstances. Laws also provide liability protections specifically for VHPs. Questions relating to employment are among the most significant issues presented by an influenza pandemic, since, if individuals fear losing their employment or their wages, compliance with public health measures such as social distancing and isolation or quarantine may suffer. It would seem possible for a court to conclude that the isolation or quarantine of individuals during a pandemic serves the public good and that the termination of individuals who are isolated or quarantined violates public policy. Employees may also have some job protection under the Family and Medical Leave Act. [ABSTRACT FROM AUTHOR]

The 111th Congress is considering legislation that would give the Food and Drug Administration (FDA) broad new statutory authority to regulate the manufacture and marketing of cigarettes and smokeless tobacco products under the Federal Food, Drug, and Cosmetic Act (FFDCA). On April 2,2009, the House passed the Family Smoking Prevention and Tobacco Control Act (H.R. 1256; H.Rept. 111-58, part 1 and 2). On May 20, the Senate Committee on Health, Education, Labor and Pensions approved an almost identical bill (S. 982). Similar legislation was first introduced in the 10Sth Congress and passed the Senate in 2004 and the House in 200S with strong bipartisan support. The Administration strongly supports H.R. 1256/S. 982. H.R. 1256/S. 982 would create a new FFDCA Chapter IX solely for the regulation of tobacco products. While the bill's language draws extensively on the FFDCA's existing provisions for regulating pharmaceutical products and medical devices, tobacco products would be regulated under new legal authority based on a public health standard rather than the safety and effectiveness standard by which the FDA regulates drugs and devices. Under the new language, FDA would have to demonstrate that any proposed tobacco product regulation was appropriate for the protection of public health, taking into consideration the risks and benefits to the population as a whole. Among its many provisions, H.R. 1256/S. 982 would require all tobacco product manufacturers to register with FDA. All registered facilities would be inspected every two years. H.R. 1256/S. 982 would require the FDA to reissue its 1996 tobacco rule, which was struck down by the U.S. Supreme Court in 2000. The rule would place new restrictions on youth access to tobacco products, end all remaining brand-name sponsorship of sporting and other entertainment events, and limit tobacco advertising in publications with a significant youth readership to black-on-white text only. In addition, the existing health warnings on tobacco product packaging and advertising would be replaced with more explicit and conspicuous health warnings. H.R. 1256/S. 982 would give FDA the authority to develop regulations restricting the sale, distribution, advertising, and promotion of tobacco products, to the extent permitted by the First Amendment. The agency also would have the authority to require changes in the design and characteristics of current and future tobacco products, such as the reduction or elimination of harmful ingredients and additives. FDA would not have the authority to reduce nicotine yields to zero or ban tobacco products. Under H.R. 1256/S. 982, manufacturers would have to obtain FDA approval in order to market a new tobacco product, unless FDA determined that it was substantially equivalent to a product already on the market, or a minor modification of an existing product. The bill would prohibit the use of descriptors such as "light" and "mild" and require manufacturers seeking FDA approval to market a product for which they intend to make a reduced-risk claim to provide evidence substantiating that claim. H.R. 1256/S. 982 would require FDA to develop new requirements for testing and reporting tobacco product ingredients and smoke constituents, and to issue new recordkeeping requirements to help counter the illicit trade of tobacco products. FDA's new regulatory activities would be paid for by user fees assessed on the manufacturers. This report provides a detailed summary of the provisions in H.R. 1256/S. 982 and discusses some of the public health and legal issues it raises. A companion report, CRS Report R40196, FDA Tobacco Regulation: History ofthe 1996 Rule and Related Legislative Activity, 1998-2008, by C. Stephen Redhead and Vanessa K. Burrows, provides more background on the FDA rule and past efforts to give the agency the authority to regulate tobacco products. Related Bills: H.R.1256 S.982 Related Reports: R40196 [ABSTRACT FROM AUTHOR]

Recent human cases of infection with a novel influenza A(H1N1) virus have been identified both internationally and in the United States. Since there has been human to human transmission and the new virus has the potential to become pandemic, it is timely to examine the legal issues surrounding this emerging public health threat. This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues. There are a number of emergency measures which may help to contain or ameliorate an infectious disease outbreak. The Public Health Service Act and the Stafford Act contain authorities that allow the Secretary of Health and Human Services and the President, respectively, to take certain actions during emergencies or disasters. While the primary authority for quarantine and isolation in the United States resides at the state level, the federal government has jurisdiction over interstate and border quarantine. Border entry and border closing issues may arise in the context of measures designed to keep individuals who have, or may have, influenza A(H1N1) from crossing U.S. borders. Aliens with the H1N1 virus can be denied entry, but American citizens cannot be excluded from the United States solely because of a communicable disease, although they may be quarantined or isolated at the border for health reasons. Airlines have considerable discretion to implement travel restrictions relating to the safety and/or security of flights and other passengers and crew. In addition, the federal government has broad legal authority to regulate and control the navigable airspace of the United States in dealing with incidents involving communicable diseases. States have authority to initiate other emergency measures such as mandatory vaccination orders and certain nonpharmaceutical interventions such as school closures, which may lessen the spread of an infectious disease. The International Health Regulations adopted by the World Health Organization in 2005 provide a framework for international cooperation against infectious disease threats. The use of these emergency measures to contain the influenza A(H1N1) virus outbreak may raise a classic civil rights issue: to what extent can an individuals liberty be curtailed to advance the common good? The U.S. Constitution and federal civil rights laws provide for individual due process and equal protection rights as well as a right to privacy, but these rights are balanced against the needs of the community. Liability issues may become particularly important during the influenza A(H1N1) virus outbreak. The Public Readiness and Emergency Preparedness Act limits liability with respect to the use of countermeasures for pandemic flu or other public health threats. A patchwork of federal and state laws exists which generally operates to protect volunteers, which may include volunteer health professionals (VHPs) under certain circumstances, and there are also laws that trigger liability protection specifically for VHPs. Questions relating to employment are among the most significant issues presented by an influenza pandemic, since, if individuals fear losing their employment or their wages, compliance with public health measures such as social distancing and isolation or quarantine may suffer. It would seem possible for a court to conclude that the isolation or quarantine of individuals during a pandemic serves the public good and that the termination of individuals who are isolated or quarantined violates public policy. Employees may also have some job protection under the Family and Medical Leave Act. [ABSTRACT FROM AUTHOR]

The Constitution of the United States of America imbues the President with broad authority togrant pardons and reprieves for offenses against the United States. This report provides anoverview of the scope of the President?s pardoning power, the legal effects of a pardon, and theprocedures that have traditionally been adhered to in the consideration of requests for pardons.Members of Congress have introduced resolutions expressing the sense of the Congress that thePresident either should or should not grant pardons to certain individuals or groups of individuals,such as H.Res. 9 in the 111th Congress and H.Con.Res. 24, H.Con.Res. 37, and H.Con.Res. 214from the 110th Congress. Additionally, Members of Congress have also proposed constitutionalamendments that would restrict the President?s pardon power, such as H.J.Res. 48 from the 110thCongress. [ABSTRACT FROM AUTHOR]

This report provides a summary of seven proposed and final rules affecting the Medicaid program that were issued by the Bush Administration during 2007 and 2008. Six of the seven rules are currently under a congressional moratorium on further administrative action until April 1, 2009. A description of possible administrative and legislative actions to modify these rules, which could be taken by the next administration or the 111th Congress, is also provided. [ABSTRACT FROM AUTHOR]

This report discusses the Special Inspector General provisions in the Emergency Economic Stabilization Act of 2008, H.R. 1424, which was enacted as P.L. 110-343 on October 3, 2008. This Act created a Special Inspector General (SIG) for the Troubled Asset Relief Program (TARP). This report will compare the duties and authorities of the SIG TARP to those of the Special Inspector General for Iraq Reconstruction (SIGIR) and the Special Inspector General for Afghanistan Reconstruction (SIGAR), as well as statutory IGs under the Inspector General Act of 1978, as amended (IG Act). [ABSTRACT FROM AUTHOR]

This report considers the constitutionality of federal tort reform legislation, such as the products liability and medical malpractice reform proposals that have been introduced for the last several Congresses. Tort law at present is almost exclusively state law rather than federal law, although, as noted in the appendix to this report, Congress has enacted a number of tort reform statutes. Part I of this report concludes that Congress has the authority to enact tort reform legislation generally, under its power to regulate interstate commerce, and to make such legislation applicable to intrastate torts, because tort suits generally affect interstate commerce. However, it may be unconstitutional for tort reform legislation to be applied to particular intrastate torts that do not substantially affect interstate commerce. In concluding that Congress has the authority to enact tort reform "generally," we refer to reforms that have been widely implemented at the state level, such as caps on damages and limitations on joint and several liability and on the collateral source rule. More specialized types of reforms are not necessarily immune from constitutional challenge. For example, some state courts have struck down statutes that provide that a portion of punitive damages awards must be paid to state funds (although other state courts have upheld such statutes). Part I also concludes that there would appear to be no due process or federalism (or any other constitutional) impediments to Congress's limiting a state common law right of recovery. The only exception concerns requiring alternative dispute resolution that limits the right to a jury trial. Part II considers alternative dispute resolution alternatives, some of which could have constitutional problems. The Seventh Amendment would preclude Congress from eliminating the right to a jury trial in common law tort actions brought in federal court. Congress may, however, eliminate the right to bring common law . . . [ABSTRACT FROM AUTHOR]

The use of carbon monoxide (CO) in the packaging of meat and fish has generated considerable debate. The presence of CO results in the meat turning a bright red color that lasts longer than the color in untreated meat. Additionally, fish treated with CO gain a fresher appearance and a red tint. The meat industry, consumer groups, scientists, and policy makers disagree as to whether the use of CO in meat and fish packaging should be regulated by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA), through labeling or otherwise, and whether CO should be a substance Generally Recognized As Safe (GRAS) under current and proposed FDA rules. Two bills have been introduced in the 110th Congress regarding the use of carbon monoxide in meat and poultry products: H.R. 3115 (the Carbon Monoxide Treated Meat, Poultry, and Seafood Safe Handling, Labeling, and Consumer Protection Act) and H.R. 3610 (the Food and Drug Import Safety Act of 2007). Both bills propose to amend section 201 of the Federal Food, Drug, and Cosmetic Act (FFDCA). Under the proposals, if CO is used to treat meat, poultry, or seafood that is intended for human consumption, and if the conditions of that use would affect the color of the products, CO must be treated as a color additive under FFDCA, unless the product's label includes a statement that is prominently and conspicuously placed to notify the consumer of the use of CO and to warn the consumer of proper factors to judge the safety of the product. This report provides an overview of the FDA's regulation of GRAS substances, which are exempt from the premarket approval process for food additives. The report next discusses the FDA's 1997 proposed rule, which would create a notification procedure for GRAS substances through which manufacturers can notify the FDA of their "determination that a particular use of a substance is GRAS." The FDA has been using this GRAS notification procedure since the publication of the proposed rule on an "interim policy" basis. The roles of the USDA and FDA are also discussed, including the 2000 Memorandum of Understanding regarding review of substances used in the production of meat and poultry products. Finally, the report examines GRAS notices regarding intended uses of carbon monoxide. [ABSTRACT FROM AUTHOR]

Congress has long taken a leadership role in establishing and sustaining offices of inspector general (OIGs), which now exist in more than 60 federal departments and agencies. This effort began with Congress's initiation of the first of the contemporary statutory inspectors general (IGs) in 1976; it has continued with passage of the broadly encompassing 1978 Inspector General Act and 1988 Amendments as well as with additions and modifications in the meantime.1 In the 110th Congress, several bills designed to increase the IGs' independence and accountability or otherwise modify specific provisions have been introduced -- H.R. 928, approved by the House Committee on Oversight and Government Reform, and S. 1723. The major changes include: a fixed term of office for IGs; removal for cause only; apprisal of the intention to remove or transfer an IG given to the Congress 15 or 30 days in advance; notification of the annual IG budget request to Congress and to the Office of Management and Budget, when the IG submits it to agency administration; establishment of a Council of Inspectors General on Integrity and Efficiency, replacing the two current councils operating under executive order; and creation of an Integrity Committee composed of Council members to investigate allegations of wrongdoing by an inspector general or officials in the office. This report, which will be updated as developments dictate, covers the main provisions of the proposals. [ABSTRACT FROM AUTHOR]

Over the past few months, the Food and Drug Administration (FDA) has fielded increasing numbers of questions regarding recalls of unsafe food imports, including pet food and toothpaste. Additionally, several domestic food products, from peanut butter contaminated with Salmonella to spinach linked to E. coli 0157:H7 to canned meat products such as chili sauce spoiled by Clostridium botulinum (botulism), have been voluntarily recalled by businesses in the last year. Recalls may decrease consumer confidence in the recalling company, food imports, or food safety agencies such as the FDA; products later subject to a recall may have sickened or killed people or pets. While the FDA only has the authority to order recalls of infant formula, medical devices, and human tissue products, the agency may request that a company recall other products, such as food, drugs, and cosmetics. This report provides an overview of the FDA's statutory authority with regard to the three types of products that it can recall, as well as FDA regulations for designating the particular class of recall, publicizing and monitoring the effectiveness of recalls, and carrying out recalls. Additionally, this report reviews the recall provisions in legislation proposed in the 110th Congress, which would give the FDA authority to require recalls of additional products. The 110th Congress has shown significant interest in the issue of food safety and several bills would grant the FDA the ability to order recalls of food products. The Senate approved, by a vote of 94-0, Senator Durbin's amendment to the FDA Revitalization Act (S. 1082), which would provide the FDA with greater recall and notification authority. The Family Smoking Prevention and Tobacco Control Act, S. 625/H.R. 1108, would provide the Secretary of Health and Human Services (HHS) with the authority to require recalls of tobacco products, while Representative Dingell's draft bill -- posted for comment on the House Energy and Commerce Committee website -- would grant the Secretary the authority to require food recalls. Other bills that would provide the FDA with recall authority include the Human and Pet Food Safety Act of 2007, S. 1274/H.R. 2108; the Safe Food Act of 2007, S. 654/H.R. 1148; and the Protect Consumers Act of 2007, H.R. 2099. [ABSTRACT FROM AUTHOR]

The article focuses on the report regarding the statutory authority of the U.S. Food and Drug Administration (FDA) to recall products. Topics included in the report are the supporting and opposing views on mandatory recall authority of the FDA, the existing statutory authority for mandatory recalls of infant formula, medical devices, and biological products, and the existing FDA regulations on voluntary recalls. Legislative proposals to grant the FDA recall authority are also mentioned.

The article discusses the permitting authority of the executive branch over the construction and operation of pipelines, conveyor belts and similar facilities in the petroleum industry in the U.S. under Executive Order 11423 promulgated in 1968.

The article focuses on a consistency issue facing the U.S. State Department in reviewing the Presidential Permit application for the Keystone XL pipeline project in the U.S. and Canada submitted by TransCanada in 2008.