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cer death among women and is the leading cause of death in women ages 40-49.

The subcommittee found that the consensus among experts is that women should be provided with access to pap tests on an annual basis. With respect to breast cancer screening, except for NCI (who had just proposed changing its screening guidelines the day before the subcommittee's hearing) and one women's health group, every medical and advocacy group that testified before the subcommittee recommended that mammogram be provided to women between the ages of 40-49 every other year. The subcommittee intends to continue its investigation of NCI's revision of its breast cancer screening guidelines.

b. Benefits. The subcommittee's activities and hearing provides clear evidence of the inadequate coverage for pap tests and mammogram under the administration's health reform plan. The hearing also produced an admission by NCI that it had not conducted any studies on American women before it proposed changing its mammography screening guidelines.

c. Hearings.-A hearing on women's preventative health care was held on October 15, 1993.

10. Review of the Department of Education's Implementation of Chapter 1 Reform.

a. Summary. The subcommittee examined the President's proposal to reauthorize the Elementary and Secondary Education Act of 1965. The subcommittee examined the effect of the administration's plan on urban districts; specifically, the benefits of shifting chapter 1 funds to high-poverty schools and the quality of the professional development programs proposed under the plan.

The chapter 1 program provides aid to local educational agencies for the education of disadvantaged children-children whose educational achievement is below the level appropriate for their age and who live in relatively low income areas. It is the largest Federal elementary and secondary education program. The fiscal year 1993 appropriation totaled over $6.1 billion. Chapter 1 is being considered for reauthorization under H.R. 3130.

The subcommittee found that the proposal significantly benefited low-income school districts by its redistribution of chapter 1 funding. However, with respect to professional development programs, the subcommittee concluded that the Department had not developed a specific and well-coordinated plan with the local educational agencies and had not provided adequate funding to ensure a substantive improvement in professional development in schools nationwide.

b. Benefits. The subcommittee hearing demonstrated the need for targeting chapter 1 funds to urban districts. The subcommittee intends to report its findings to the Education and Labor Committee.

c. Hearings. A hearing on October 19, 1993, was conducted on the "Improving America's Schools Act of 1993" and the implications for urban and low-income school districts.

11. Unfunded Federal Mandates.

a. Summary.-Congress has passed over the last 10 years 172 requirements or mandates on State and local governments. During that same period Congress cut funding to those governments by 75 percent. The Congressional Budget Office has estimated that the cumulative cost of new regulations imposed on State and local governments between 1983 and 1990 is between $8.9 billion. This has created an untenable situation for State and local governments. Most jurisdictions have had to reduce their work force, social service and infrastructure programs. This has helped to create overcrowded conditions in our prisons, and decreased capital expenditures for items such as road repair or the repair of school buildings. At a hearing in Harrisburg, PA, the subcommittee received testimony that Pennsylvania's budget will be nearly $1 billion over last year's budget, principally because of increased Medicaid spending. Many of the local officials testified that this increase, coupled with the State's balanced budget requirement, undermines Pennsylvania's ability to respond to other pressing public needs, and to create jobs.

A Clinton County commissioner testified that mandated services make up in excess of 80 percent of the counties budget. The Adams County commissioner testified that because the Federal Clean Drinking Water Act now requires testing for "parts per billion" of an expanded list of possible pollutants, and since only 2 to 5 percent of the water is actually used for drinking purposes, it might be cheaper for the municipal authority to purchase and distribute bottled water, than to comply with new Federal clean water standards.

The chairman of the Pennsylvania Senate Committee on Intergovernmental Affairs testified that the State will pay $118 million for curb cuts under the Americans with Disability Act [ADA], while full compliance with ADA would cost Philadelphia $260 million. Because of inadequate Federal funding of the low-income home energy assistance program, approximately 90,000 eligible Pennsylvanian families will not receive help this year to pay their winter fuel bills.

Unfunded Federal mandates are taking an increasing portion of the budgets of State and local governments. These mandates provide little flexibility with which Pennsylvania, and other States can make difficult and painful decisions about how to meet the social services and economic needs of its residents.

b. Benefits. Greater flexibility and increased funding for Federal mandates would provide better implementation of Federal policies. c. Hearings.-A hearing was held on "The Impact of Federal Mandate on State and Local Governments," in Harrisburg, PA on October 25, 1993.

12. Reinventing the Federal Food Safety System.

a. Summary.-Between November 1992 and February 1993, more than 500 people became ill and 4 died because of infections with E. coli O157:H7, a deadly strain of bacteria, linked to undercooked hamburger from a fast-food chain. Food-borne disease is a growing public health problem in the United States that is preventable, according to the Centers for Disease Control and Preven

tion. CDC estimates that at least 9,000 people die and up to 80 million become sick because of food-borne disease annually. The medical and other costs of food-borne illness are estimated to reach up to $23 billion per year.

The Federal Food Safety System has evolved piecemeal over the last 100 years, usually in response to a specific economic or health threat. Currently, 12 Federal agencies spend about $1 billion annually to administer about 35 laws governing food safety and quality. GÃO has concluded that fundamental differences in agencies' missions, responsibilities, inspection approaches, and enforcement authorities have led to fragmented oversight, inconsistent and illogical treatment of food products posing similar risks, inefficient use of resources, and poor interagency coordination. The greatest problems lie in the division of responsibility between the two primary agencies-the U.S. Department of Agriculture (USDA), which oversees meat and poultry, and FDA, which oversees almost all other food products.

On September 7, 1993, the Vice President's National Performance Review recommended transferring the meat and poultry inspection functions from USDA to FDA. To investigate the need for reinventing the Federal food safety system, the subcommittee began a series of hearings focusing first on the progress USDA is making to implement the initiatives it announced in the wake of the E. coli 0157:H7 outbreak to modernize meat and poultry inspection. Future hearings will focus on FDA.

Testimony from three mothers whose children had all been painfully-in one case fatally-poisoned by E. coli 0157:H7 clearly demonstrated the dangerous flaws in USDA's inspection programs. Several witnesses testified that USDA has known since at least 1985 that its inspection programs, which rely on visual inspection, cannot detect or prevent deadly microbes in meat and poultry. Public health officials, consumer advocates, GAO officials, and others testified that USDA has failed to improve its programs because its primary mission, to promote agriculture, has overshadowed its responsibilities to protect consumers and that it lacks a "public health" focus. However, witnesses disagreed on reorganizing Federal responsibility for meat and poultry safety.

The subcommittee was unable to fully assess the progress USDA is making to reform meat and poultry inspection because the Department did not comply with the subcommittee's request for information. During the hearings, however, USDA agreed to provide all the requested data by December 17, 1993.

b. Benefits. The subcommittee's hearings revealed that USDA's current meat and poultry inspection programs do not adequately protect the public from deadly microorganisms. As a result of the subcommittee's oversight, USDA is developing a detailed status report on and a management plan for its inspection initiatives. This information will enable the Congress to hold USDA accountable for making the necessary improvements in its inspection programs that will, ultimately, better protect the public. The subcommittee's hearings also laid the groundwork for considering the Vice President's proposal to reorganize Federal food safety efforts.

c. Hearings.-The hearings on "Reinventing the Federal Food Safety System: USDA's Progress in Reforming Meat and Poultry Inspection," were held on November 4 and 19, 1993.

13. Investigation of Deaths Related to the National Institutes of Health [NIH] Clinical Trials of Fialuridine (FIAU).

a. Summary.-On June 26, 1993, NIH terminated a clinical trial of FIAU on an emergency basis because of liver failure in a patient. Since then 5 of the 15 patients tested during the trial have died and 3 others have experienced serious liver and kidney damage. NIH was testing FIAU on patients with chronic hepatitis B, a virus that attacks the liver and can lead to cirrhosis and cancer of the liver. In July 1993, the subcommittee began investigating what has been called one of the most catastrophic human experiments.

On September 24, 1993, the senior NIH physician responsible for the ill-fated trial arbitrarily and capriciously terminated all NIH followup medical care and advice to a patient who had been involved in an earlier FIAU trial at NIH. The action appeared to be a vindictive, retaliatory response to criticisms of NIH's conduct of the FIAU trials that the patient had made earlier at an FDA advisory committee meeting. In an October 21, 1993, letter to the Secretary, HHS, the subcommittee chairman expressed his outrage over this unethical action and requested immediate restitution of the patient's rights. Because of the tragedy involved, and NIH's failure to cooperate with the subcommittee's request for information, and unethical behavior by a senior NIH physician, on October 29, 1993, the chairman further requested that HHS convene a special commission of outside experts to review the medical and ethical conduct of the NIH FIAU trials and FDA's role in approving the trials.

On November 12, 1993, FDA released a task force report on the tragic FIAU trial which concluded that both NIH researchers and the drug's sponsor had been too optimistic about the safety and efficacy of FIAU and had missed early warning signs about the drug's toxicity. FDA determined that at least five additional people had died in previous FIAU drug trials. The task force recommended several changes in the way drug trial data are collected and analyzed.

On December 9, 1993, the Public Citizen's Health Research Group issued a report asserting that the drug's sponsor, Eli Lilly, had withheld data on FIAU's toxicity from FDA which could have prevented some of the FIAU-related deaths had the data been reported as required under FDA regulations. FDA has been evaluating whether the investigators and sponsors complied with FDA regulations governing the conduct of clinical trials.

The subcommittee's investigation is continuing.

b. Benefits. As a direct result of the subcommittee's oversight, HHS has (1) restored medical care to a former NIH patient; (2) disciplined the senior physician responsible for the unethical action; and (3) agreed to sponsor a complete and thorough external evaluation of the FIAU clinical trials, including FDA's role, by the Institute of Medicine, National Academy of Sciences.

c. Hearings. No hearing was held on this subject.

14. Viability of Poison Control Centers.

a. Summary.-Funding for poison control centers around the country is drying up and communities are in jeopardy of loosing a vital health service. Many centers have had to cut off or reduce services and educational efforts because of funding cutbacks. For example, in January 1993, the poison control center in Grand Rapids, MI, stopped providing service to callers from neighboring area codes because of funding cutbacks. Poison control centers in Washington, DC, Arizona, and California are planning to go out of business permanently in early 1994 because of lack of funds.

Terminating poison control centers is a bad investment in the Nation's health. Poison control centers save lives and save money. In 1991, poison control centers provided advice, emergency treatment, and followup over the telephone to almost 2 million poisoning cases, about 60 percent of them involving children under 6. Because the majority of cases reported to poison centers can be handled over the phone in the patient's own home the cost of treatment is much less than hospital emergency room care. Several studies have shown that every dollar spent on poison control centers saves between $4 and $8 in emergency room costs.

However, because poison center services are usually provided without charge to patients and reduce the need for health care facility treatment, they do not generate revenue and may, in fact, reduce revenue to nearby facilities. As hospitals try to cover the costs of uninsured patients they are cutting back on nonrevenue generating operations, such as poison centers.

Subcommittee staff have been working with the American Association of Poison Control Centers to determine the financial status of U.S. poison centers and identify funding options.

b. Benefits. The subcommittee's investigation can call attention to the funding crisis facing poison control centers and identify options for maintaining this vital public health service.

c. Hearings. No hearing has been held on this subject.

COMMERCE, CONSUMER, AND MONETARY AFFAIRS SUBCOMMITTEE 1. An Updated Review of Tax Administration Problems Involving Independent Contractors.

a. Summary. Since 1989, the subcommittee has been investigating approaches to address the problem of the classification of workers as either employees or independent contractors. If a worker is classified as an employee, then the employing business is responsible for filing W-2 forms, withholding certain taxes, and paying other taxes, such as the employer portion of Social Security. If a worker is an independent contractor, the business must merely report service payments made under a contract with the worker on Form 1099 Misc. However, failure to properly classify a worker triggers heavy penalties against the business using the worker if that worker should be treated as an employee and not as an independent contractor.

Consistent testimony before the subcommittee since 1989 has indicated that the criteria used to establish the proper classification is extremely vague and has led to considerable litigation and heavy

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