Gosar introduces bill to regulate body-donor facilities

• The donors of bodies save the cost of burying or cremating their loved ones and can have the satisfaction of serving a greater good.
• While companies that broker tissue and organs for transplant into living patients are strictly regulated%2C those that sell body parts for research and education are not%2C A
• The investigation into Biological Resource Center is ongoing%2C a source close to the case told The Arizona Republic on Thursday.

U.S. Rep. Paul Gosar introduced legislation Thursday to regulate the labeling, transporting and licensing of human tissues for medical research and education.

The Arizona Republican's bill comes as the FBI, Arizona Attorney General's Office and other law-enforcement officials are investigating whether the Biological Resource Center in Phoenix and facilities in other states handled bodies as donors intended, and whether they properly screened for infectious diseases.

Body donation is a burgeoning industry, profiting by soliciting donated tissues and organs, which are provided for a fee to drug firms, medical-device manufacturers, universities and hospitals to study diseases, develop treatments or perfect surgical techniques. Companies that broker tissue and organs for transplant into living patients are strictly regulated, but those that sell body parts for research and education are not, state law-enforcement officials and experts say.

Last spring, the Maricopa County Department of Public Health warned 25 current and former employees of Biological Resource Center that they should be tested for HIV, hepatitis and tuberculosis because they may have been exposed to "blood and body tissues of infected cadavers." The Centers for Disease Control and Prevention said it was investigating potential exposure to the same diseases "among workers performing preparation and dissection procedures on human non-transplant anatomical materials ... in Arizona."

Gosar's bill would require non-transplant facilities to put labels on shipments containing body parts that certify the parts have been screened for infectious diseases. The requirement would apply to shipments of body parts across state lines.

The legislation also directs the U.S. secretary of Health and Human Services to establish requirements for the approval, suspension and revocation of non-transplant tissue-bank licenses.

Currently, New York has the most stringent licensing requirements for non-transplant body-donor facilities and is the only state that requires licensure to move tissue in and out of that state. Oregon passed legislation last year requiring the two body-donation facilities operating there to register with officials and undergo regular inspections.

Under the bill, any authorized representative of the federal health agency or a nationally recognized accrediting organization can enter and inspect a non-transplant body-donation facility "for the propagation or recovery and preparation of any human tissue specimen."

If it's determined the tissues licensed under the legislation present "an imminent or substantial hazard to the public health," federal health officials must immediately order the recall of the tissues.If a facility is found to put the public at risk for violating the bill's provisions, it can be charged with a misdemeanor and fined $10,000 daily.

Gosar's legislation, if approved by Congress and signed by President Barack Obama, would not cost any additional money to implement.

Jeff Small, Gosar's legislative director, told The Arizona Republic that as a dentist, the representative wants to ensure the public's safety is not jeopardized.

Added Small, "He felt the need to step in and provide some oversight in what appears to be a somewhat unregulated industry."

Andrew Pacheco, the criminal division chief for Arizona's Attorney General's Office, said Attorney General Tom Horne welcomes any attempts to develop regulations in an industry that has "a paltry few."