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FDA, States Collaborate for Safety's Sake

When Congress passed the Mammography Quality Standards Act in 1992 requiring federal certification of U.S. mammography facilities, regulators faced the daunting task of inspecting and accrediting the 10,000 mammogram providers scattered across the country.

If the Food and Drug Administration--responsible for enforcing the certification--had tried to tackle this alone, the task would have been nearly impossible because of limited resources. The agency gets the job done by drawing on a decades-long alliance with state departments.

Mammography facility inspection is part of a larger initiative to protect the public against adverse health effects of radiation exposure. It is one of four major FDA-state collaborations. Others involve retail food protection, shellfish sanitation, and milk safety.

"FDA does not have primary responsibility to enforce compliance for the commodities covered under the cooperative programs," says David Field, state programs director for FDA's Northeast Region. "The states do that. They have the police power."

In the case of mammography, FDA does enforce the law and does inspect some facilities itself, such as those in the military and in states without contracts with the agency. However, for thousands of other inspections, FDA trains, audits, and provides technical expertise to state inspectors under contract to FDA to do inspections.

The four FDA-state programs are unlike most others within the agency because they run by authority of the Public Health Service (PHS) Act, not the Federal Food, Drug, and Cosmetic Act, from which most of FDA's regulatory authority comes.

The PHS Act directs FDA to "assist states ... in the prevention of communicable diseases" and to advise states "on matters relating to preservation and improvement of the public health."

More informal federal partnerships with states date back to the early part of this century. In the 1920s, the Industrial Revolution changed America's food habits. The shift away from an agricultural economy meant, for example, that "many people no longer had a cow in their backyard, so they were buying milk from the local store," says Field. But because the industry lacked standards and controls, outbreaks of food-borne disease occurred from milk that had been contaminated somewhere along the processing route. Shellfish had similar tainting problems. In 1925, several states asked the surgeon general for help in stemming the rise of shellfish-related illnesses such as typhoid. In response, the surgeon general held a conference that created the framework for PHS programs that advise, train, and generally oversee shellfish sanitation programs.

FDA-state alliances nowadays are governed by memoranda of understanding with various national conferences, where federal and state officials, along with industry representatives and others, meet either yearly or biannually to review or revise procedures.

"The states come to the table, they have voting authority, and they examine ordinances, operational manuals, or pertinent issues to make sure everyone is going to be playing the same tune," says Field.

FDA uses its six administrative regions--Northeast, Mid-Atlantic, Southeast, Midwest, Southwest, and Pacific--as geographic sectors for cooperative programs, with each region responsible for a cluster of states. Working within these regions, state officials can readily consult with FDA experts about technical problems. The proximity also allows FDA regional personnel to audit state programs easily. And states in each region can arrange easily to have FDA conduct training for state inspectors.

Radiological Health

FDA's training role is crucial to the success of the cooperative programs because in many cases state inspectors--such as those who inspect mammography facilities--must be certified to perform a regulatory function. The training, much of it available only from FDA, is required for getting and maintaining certification.

Often, as in the radiological health program, states need a steady flow of trained inspectors. "If you're a state radiation control director, and you lose a seasoned member of the staff, it's tough," says Richard Gross, associate director for liaison in FDA's Center for Devices and Radiological Health. "You have to quickly bring someone else up to speed to keep up with the workload. That's where FDA really helps by offering the states specialized training [to individuals]."

Protecting the public from potentially harmful radiation effects is a duty shared by at least five federal agencies, including the Environmental Protection Agency, the Nuclear Regulatory Commission, the Department of Labor, and the Centers for Disease Control and Prevention, as well as FDA. But at the state level, these responsibilities typically are focused into a single division. This allows a more comprehensive approach to regulating local radiation sources, which include x-rays, radioactive materials, microwave devices, lasers, and even ultraviolet-source instruments.

The collaboration works well because federal agencies often have a greater concentration of technical expertise and scientific resources. But the states can respond to public health emergencies more quickly. States also have personnel resources close to the sources of problems and can act rapidly to resolve them.

The Conference of Radiation Control Program Directors guides FDA-state programs in radiological health. One of the conference's main activities is a yearly survey that gauges the quality of a specific x-ray--a dental bite-wing exam, for instance--from a random sampling of facilities nationwide. "The states voluntarily oversee data collection for these surveys," says Gross, "while FDA lends technical expertise and helps develop standard protocols [for gathering the data]."

The conference then distributes the data to trade groups (the American Dental Association, for example) and state health departments as a measure of radiological exposure nationwide to patients for the particular test studied.

These data also show trends. A review of survey data on mammography quality from 1985, 1988 and 1992 indicates a 34 percent improvement in image quality and a 20 percent decrease in the "mean glandular dose" of radiation required to produce a quality image. This, Gross says, is consistent with the program's goal of reducing unnecessary public radiation exposure.

Retail Food Protection

More than 3,000 state and local government agencies regulate the country's retail food industry. They are responsible for over 1 million food establishments--restaurants and grocery stores, as well as vending machines, cafeterias, and other outlets in health-care facilities, schools, and correctional facilities. FDA's regional food specialists provide training, program evaluation, and technical assistance to these agencies.

State health officials may request to be "standardized" in the Food Code before they inspect food establishments. The Food Code is a model of food safety standards FDA introduced in 1993 and updated in 1995. States are encouraged to adopt this code as a sound technical and legal basis for their own regulation of retail food establishments.

The standardization process, which tests an official's performance in actual inspections, begins at FDA headquarters. A standardizing officer from the agency's Center for Food Safety and Applied Nutrition and an FDA regional food specialist inspect numerous food establishments jointly, using a checklist that includes factors such as management knowledge, food employee health, hand cleanliness, and time and temperature management of potentially hazardous foods.

The regional specialist's ratings must agree with at least 80 percent of the standardizing officer's ratings of items on the inspection form. The regional standardized specialists then use the same method to standardize state officials, who, in turn, can standardize county and local inspectors.

FDA regional specialists also give the states technical assistance. For example, state officials recently asked FDA for help in responding to food-borne illness outbreaks, including incidents of contamination by the bacterium E. coli O157:H7 in Missouri, Washington, Oregon, and Texas, as well as a Texas botulism outbreak. Regional specialists provided states with information on the relevance to the problem of food additives, microbiology, ethnic foods, and plumbing.

In other instances, FDA regional specialists helped states ensure food safety after disasters such as floods and earthquakes. They are assisting with major food-service events such as the 1996 Olympics in Atlanta and the 1996 Boy Scout Jamboree in rural Virginia.

As in the radiation health program, training is critical in the food programs. Regional food specialists conduct many workshops for state health departments. For example, in 1994, FDA began offering training to familiarize state officials with the Food Code, and states now look to FDA for guidance in interpreting and applying the code.

The Food Code includes standards for such things as cooking times and temperatures, refrigeration temperatures, and storage requirements for many kinds of foods. In 1994, Rhode Island was the first state to implement the Food Code as law. But that was just a first step.

"After we got the code through, the high priority was training people on what the code is," says Ernest Julian, Ph.D., chief of Rhode Island's division of food protection. "FDA was of great assistance there, putting together a Food Code course for us. And now if we have questions about the code, we can go to FDA and have those answered."

Shellfish Sanitation

The shellfish program is governed by the Interstate Shellfish Sanitation Conference, which was established in 1982 and meets each summer for seven days. In April each year, conference members--FDA, states, industry representatives, the Environmental Protection Agency, and the National Marine Fisheries Service--submit ideas and issues for consideration by the conference. One of three task forces, made up of conference members, examines each issue and makes a recommendation to the general assembly, which includes only state representatives who vote on the issue.

In 1994, FDA offered the conference an option for controlling the potentially hazardous Vibrio vulnificus bacterium in raw oysters. The option suggested a ban on harvesting oysters for raw consumption from Gulf of Mexico waters between April and October. The conference rejected that option but agreed to a year-long study of time and temperature factors that can reduce the risk of Vibrio infection in medically compromised individuals. In early summer 1995, the states, with FDA's input, offered another option based on oyster refrigeration when the water reaches a certain temperature. For example, oysters taken from an affected site during a month with an average monthly maximum water temperature of more than 84 degrees F (29 degrees C) would have to be chilled within six hours of harvesting. Oysters taken from cooler waters could be kept unchilled longer. This time, the conference's voting members approved the measure.

"Sometimes FDA is placed in a situation where it must compromise to get an issue approved by the conference," says Stan Ratcliffe, team leader for shellfish programs in FDA's Center for Food Safety and Applied Nutrition. "Other times the agency might have to accept defeat of its proposals."

Like the food safety program, FDA's Shellfish Sanitation Program has a regional staff that interacts with state officials to help bolster enforcement programs. These shellfish specialists audit state programs to ensure compliance with laws, regulations and requirements of the National Shellfish Sanitation Program (NSSP) and other criteria agreed on by the Interstate Shellfish Sanitation Conference. Their goal is to ensure that state officials comply with the NSSP in classifying harvesting waters, controlling illegal harvesting, as well as overseeing processing plant conditions and product labeling.

The shellfish program also provides states with training, technical assistance, and results of scientific research. FDA shellfish specialists use a process similar to that of food specialists for standardizing state inspectors.

Milk Safety

FDA assists states in preventing disease transmitted through milk and helps enforce state milk regulations. It promotes and helps ensure compliance with the model Grade A Pasteurized Milk Ordinance, a document similar to the Food Code. FDA's regional milk specialists offer seminars to state officials to promote uniformity in interpreting the Pasteurized Milk Ordinance, as well as on other issues such as laboratory analysis methods.

The milk program has an auditing feature called check rating, which doublechecks state evaluations of milk sources. FDA produces a quarterly Interstate Milk Shippers list of ratings states have given to interstate milk plants and farms. "We then go in and check rate, or justify, the rating the state has given," says Field.

FDA regional milk specialists, like their counterparts in retail food and shellfish programs, standardize state officials, after themselves being standardized by FDA headquarters. Milk specialists also track public health problems, such as those caused by bacterial contamination, to assess the impact of state control programs and the effects of FDA's activities on promoting public health.

The four FDA-state cooperative programs all have their own strategies, but their methods of helping states are similar. "For a state compliance officer with four or five programs to worry about, it can be difficult to know who's on first," says FDA's Richard Gross. "That's why there's been an effort to make these [cooperative] programs similar."

FDA officials also say the programs make good economic sense. Says FDA's David Field: "For a small amount of resources, FDA is able to influence and give good direction to four major industries across the country."

John Henkel is a staff writer for FDA Consumer.

Battling AIDS Fraud

FDA has joined with several states to form the AIDS Health Fraud Task Force Network, a grassroots cooperative striving to curb AIDS fraud through various information programs. So far, California, Colorado, Florida, Georgia, Illinois, Louisiana, Michigan, Minnesota, Ohio, and Texas have created task forces, each with its own programs tailored to the state's needs.

"Our hope is that eventually all 50 states will come aboard the program," says Richard Barnes, director of FDA's division of federal-state relations. Task forces include federal, state and local officials, along with members of AIDS service organizations, academia, businesses, and AIDS medication "buyers' clubs." FDA funds the task forces.

The 6-year-old task force network is not a law enforcement body, though it sometimes refers suspected fraud cases to state or federal regulators. Instead, the network seeks to abolish fraudulent activities by sponsoring consumer education through telephone hot lines, newsletters, public service announcements, exhibits, and videos. Because they regard AIDS fraud as common and costly for people with AIDS or infected with HIV (the virus that causes AIDS), task force members help patients steer clear of fraudulent operations. Patients can report suspected fraud to task forces (the phone numbers are listed in local directories under state services). Task forces also help patients make informed choices about legitimate treatments.

A clear advantage of the task forces is speed, says Lynne Isaacs, AIDS coordinator in FDA's Florida district office. "If suspected fraud is found, the task force can rapidly alert the news media, which gets the message to the public."

One recent Florida case involved a hand lotion the distributor claimed could block HIV and eliminate the need for health workers to wear protective gloves. The task force quickly spread the word about this unproven product, and FDA sent a warning letter to the company, which resulted in the company canceling its advertising.

Collaborating with states makes good sense, Barnes says, because "FDA cannot stop AIDS fraud alone. Fraud happens at the local level, and that's where exposure of the fraud should take place."

Barnes emphasizes that AIDS fraud is not an isolated problem affecting a small patient population. It is part of a much larger problem that has negative consequences for the country's economy. "Let's face it," Barnes says, "when someone is involved in health fraud, it ends up costing all of us."

--J.H.