Public Health Laboratories and Health System Change . Other Federal Agencies and PHLs

10/06/1997

Most federal involvement with state PHLs is via the CDC. In addition, several other federal health agencies operate laboratories related to public health.

FDA, EPA, USDA

The FDA, the USDA, and the EPA may interact with PHLs on food safety and limited environmental issues.11 In general, the USDA focuses on the safety of raw agricultural products, the EPA focuses on pesticides and associated acute toxicity, and the FDA focuses on finished food products (although they may help USDA with analytics in terms of testing). The interactions among the various players are multiple and complex, with shared communications and memoranda of understanding. Figure 10 depicts the interrelationships among these agencies in food safety functions, the primary area of interchange pertinent to this study.

Figure 10: Federal Agencies Involved in Food Safety Activities

Figure 10: Federal Agencies Involved in Food Safety Activities

The various federal agencies' roles during a food-borne disease outbreak offer some additional guidance for understanding their relationships and responsibilities:

  • FDA focuses on collecting food samples, analyzing them, and working with industry to contain the problem within food products (e.g., pulling the product off store shelves).
  • USDA focuses on examining raw agricultural products as a possible source of disease.
  • CDC focuses on epidemiology B consulting with physicians and patients, tracing the source of outbreaks, and working with the FDA to establish links between food products and disease outbreaks where appropriate.

The FDA has primary oversight responsibilities for food product safety and applied nutrition, and for drugs, devices, biologicals, agricultural products, and veterinary products. Given these roles, the FDA activities bear directly upon PHL functions, and the remainder of this section will discuss relevant FDA activities. However, since the FDA is primarily focused on products and enforcement as opposed to medical/clinical testing, they essentially perform different operations than state PHLs, and the level of interaction with them is minimal. In addition, the FDA's role, by statute, is limited to interstate commerce (i.e., they have no purview over intrastate commerce).

The FDA and the CDC often provide assistance to state health agencies during food-borne disease outbreaks, especially those that cross state lines. For example, the FDA played a significant role during the recent outbreak of E. coli in Odwalla apple juice in California and Washington. While the Washington and California SHAs initially responded to the outbreak, the FDA used its regulatory authority to pull the apple juice from store shelves, helped locate where shipments of the apple juice had gone, helped the SHAs in the inspection of apple juice plants, and conducted its own microbiologic tests of apple juice samples to test for presence of E. coli. During the outbreak, the CDC's involvement was minor; it coordinated with the Washington State Office of Epidemiology to confirm the number of E. coli related illnesses.

Most FDA laboratory work is coordinated through field offices with laboratories, and centers around oversight and enforcement. For example, the FDA collects food samples to look for pesticides and pathogens. They also perform some analytical chemistry, often in cooperation with CDC and other agencies, to respond to food-borne disease outbreaks. The FDA also focuses on development of methods for laboratory testing of foods, since it is one of the primary organizations that engages in this activity extensively. Finally, the FDA is currently developing genetic markers and performing analyses that overlaps somewhat with the genetics work of state PHLs. The FDA is performing much less work than it had previously on chemical carcinogens and pesticide residues in food, and now places much more emphasis on more immediate microbiological concerns. In fact, the emphasis of the FDA is currently on acute toxicology, rather than chronic toxicity.

The FDA has eighteen field laboratories across the country that collect food samples and test them. The main emphasis of the laboratories is on food safety regulation, and the FDA central offices coordinate these activities. In addition, there are some food laboratories in Washington, D.C. that develop methods for food surveillance; and these are disseminated to and used by the field laboratories. The central office focuses more on immediate crises (e.g., outbreaks) and less on routine surveillance of industry. In addition, there are several FDA laboratories that serve as national research centers. For example, there is a large toxicology laboratory in Alabama that concentrates on inspecting seafood from the Gulf of Mexico. The FDA's National Center for Food Technology in Chicago also serves as a major testing development site and focal point for creating and overseeing the Hazard Assessment and Critical Control Points initiative, whereby industry implements quality control measures to ensure food safety. Finally, FDA maintains a primary research site (with no regulatory functions), the National Center for Toxicological Research, in Little Rock, Arkansas.

In addition to the activities described above, the FDA is involved with the CDC in a special public health program called the Sentinel Sites Initiative. The purpose of the Sentinel Sites Initiative is to obtain improved estimates of presence of food-borne disease agents. The program is being conducted by the CDC with support (both collaboration and funding) and coordination from the FDA and the USDA. The CDC program is coordinated through state PHLs, but county and city laboratories, private laboratories, and FDA field laboratories are also involved.

Under current surveillance procedures, the CDC collects epidemiologic data on many diseases. The CDC uses estimation techniques to multiply the reported numbers to reflect the likely actual number of cases for a given disease. The Sentinel Sites Initiative aims to improve these estimates by conducting extensive food culturing for four main pathogens (each of which causes similar diarrhea and feverish symptoms):

  • E. coli 0157:H7
  • Salmonella
  • Campylobacter jejuni
  • Listeria monocytogenes

The culturing, coupled with heightened disease surveillance, is intended to help establish stronger links between the presence of micro-organisms in foods and incidence of food-related illnesses. In turn, these stronger links and better data should allow for more precise estimation of the true incidence of food-borne illnesses, and ultimately the cost of these illnesses to society. The initiative should increase understanding of these diseases and their associated costs, and also help FDA, CDC, and PHLs justify their core functions.

HCFA(now known as CMS) Role In Public Health Laboratory-Related Issues

HCFA(now known as CMS) is the agency responsible for the licensing of all clinical laboratories in the United States, with the exception of research laboratories, through the Clinical Laboratory Improvement Amendments, 1988 (CLIA ' 88). Many state PHLs are the licensing entities for CLIA ' 88, thereby assuming responsibility for assuring the quality of clinical lab testing in the state. Two states (WA and OR) have full exemptions from HCFA(now known as CMS) to operate programs accepted as the equivalent of CLIA ' 88. CLIA ' 88 requires laboratories to obtain certification, and to comply with regulations in six broad areas of laboratory operations:

  • proficiency testing
  • personnel
  • inspections
  • patient test management
  • quality control
  • quality assurance

HCFA(now known as CMS) is responsible for the enforcement of CLIA '88, including the approval of proficiency testing programs, accreditation programs, and state exemption applications for clinical laboratories.12 In order to comply with CLIA ' 88, clinical laboratories must first register themselves with HCFA(now known as CMS). After registration, HCFA(now known as CMS) surveys the laboratory and determines the laboratory's level of compliance with CLIA ' 88 guidelines. Upon determination of compliance, HCFA(now known as CMS) issues a certificate and collects the appropriate fees from the laboratory. In many instances, clinical laboratories can demonstrate compliance with CLIA ' 88 by using a HCFA(now known as CMS)-approved accreditation organization (e.g., Joint Commission on Accreditation of Healthcare Organizations, College of American Pathologists, Commission on Office Laboratory Accreditation).13