The legal powers of health agencies--recent developments. (Legal Briefs).

This month's column addresses recent developments in the way the legal powers of health agencies are defined. Environmental heath programs are generally operated by government agencies. In is axiomatic that "the source of the administrative agency's power is to be found in law-that is, it derives it power by delegation from the legislature." (1) Therefore, an environmental health agency has only those powers delegated it.

Cases 1 and 2 concern an agency's powers. The first case is a review of the infamous decision about the U.S. Department of Agriculture's (USDA's) Salmonella rule. The second case is from Pennsylvania. It addresses the question of which agency in that state has jurisdiction over drinking water. Case #3 is an affirmation of an environmental health agency's power to close a polluting facility.

Case #1: USDA Salmonella Rule Invalid (2)

In 1996, USDA adopted regulations designed to reduce pathogens; those regulations mandated a hazard analysis and critical control point (HACCP) system in meat plants. The requirement was strongly supported by public-health officials. To determine compliance with the regulations, USDA tested for Salmonella in a meat plant's finished product. If a facility failed three consecutive tests, USDA concluded that the facility had failed to "maintain sanitary conditions" and withdrew its inspectors and certification, which are necessary to sell beef interstate.

Supreme Beef was a meat processor and grinder in Texas. It failed the Salmonella standard three times, and USDA notified the company that it was withdrawing its inspectors. On the day the USDA inspectors were to leave the plant, Supreme Beef filed a lawsuit against USDA claiming the agency had exceeded its authority.

The Federal Meat Inspection Act requires that no adulterated meat pass USDA inspection. Meat is adulterated if it is prepared, packed, or held under insanitary conditions. The statute authorizes USDA to prescribe sanitation regulations. USDA believed its regulations for pathogen reduction mandating a HACCP system were necessary to ensure the safety of meat.

The agency admitted, however, that Salmonella is not an adulterant per se, because it is found in a substantial proportion of meat products. USDA also did not claim that a facility's failure the meets the Salmonella performance standard served as a proxy for meat contaminated with filth. Nonetheless, USDA argued it had the power to regulate the Salmonella levels of incoming raw materials used in grinding establishments such as Supreme Beef, and that Salmonella levels are a proxy for pathogen controls required by the regulations.

Normally, an administrative agency's regulations are consistent with the statute. According to the federal appeals court, the words of the statue were clear. The use of the word "rendered" in the statute meant that for USDA to have jurisdiction, the deleterious change must occur while the meat is being "prepared, packed or held" and must be caused by unsanitary conditions in the facility. USDA had no statutory authority to regulate the levels of nonadulterant pathogens such as Salmonella because it was not an adulterant per se. In addition, the statute gave USDA no authority over the characteristics of raw material coming into the facility. The court said:

The Salmonella performance standard, however, does not purport to measure the differential between incoming and outgoing meat products in terms of Salmonella infection rate. Rather, it measures final meat product for Salmonella infection. Thus, the performance standard, of itself, cannot serve as a proxy for cross-contamination because there is no determination of the Salmonella baseline. Moreover, the USDA has not asserted that there is any correlation between the presence of Salmonella and the presence of [section] 601(m)(1) adulterant pathogens.

Since the Salmonella performance standard exceeded USDA's authority, it was invalid.

By contrast, FDA regulations, based on identical language in the Food, Drug, and Cosmetic Act, requiring the heating of smoked fish to prevent the formation of botulism toxin previously had been upheld. Those regulations were valid because they did not seek to control the level of Clostridium botulinum in incoming fish, but required heating and salination inside the plant to inhibit spore growth in the finished product.

The USDA ruling has been roundly criticized in the media. (4) The lesson from this case for environmental health personnel is simple, however. No matter how much an idea may improve public health, an agency must have statutory authority to establish and operate a program. The validity of an environmental health program is not measured by good intentions, or even by good results.

Case #2: Drinking Water Quality in Pennsylvania (5)

The Pennsylvania Public Utility Commission (PUC) determined that the drinking water from Redstone Water Company, a public utility, was unfit for basic domestic purposes, and ordered the company to perform a feasibility study to determine the most cost-effective method of improving drinking-water quality and water pressure. PUC has jurisdiction over the water service provided by a utility.

On the other hand, the Pennsylvania Safe Drinking Water Act vests authority over drinking-water quality in the Department of Environmental Protection (DEP). The issue in this case was which state agency had jurisdiction over a situation in which Redstone was providing its customers with excessively hard water, water with a sulfur smell, and low water pressure.

The court that heard the case decided that PUC has a statutory procedure to assess water quality by obtaining a certification of water supply purity from DEP. No delegation of authority has been given the PUC concerning water quality. Therefore, only DEP may regulate water quality in Pennsylvania.

On the other hand, water pressure is a service issue over which PUC has jurisdiction. A PUC decision will be upheld if supported by substantial evidence. Substantial evidence is that minimal amount of credible evidence needed by a reasonable person to support a decision. It is more than a mere scintilla but less than a preponderance of evidence. In this case, however, the only negative evidence regarding the water pressure was a "best guess" based on a mathematical formula and without any actual samples. That was insufficient to support the PUC order, and the order was voided by the court.

Case #3: Enjoining a Polluter (6)

The Crane Point Resort and Marina in Monroe County, Florida, was located on a peninsula overlooking the Gulf of Mexico. It used a cesspool to dispose of its sewage waste. The health department issued a violation citation. After 18 months, the situation was not corrected. So the department sought an injunction to close the facility.

An injunction was issued by the circuit court and upheld by the court of appeals. The court said: The use of common cesspools in itself involves permitting the presence of untreated human waste on Crane's property which, under ... Florida Statutes ... is "prima facie evidence" of a sanitary nuisance.

According to the court, Crane's operation may place the community in danger of serious illness. Therefore, the injunction closing the facility was proper. The resort may seek to reopen after completion of the sewage disposal system.

References

(1.) F. Grad, Public Health Law Manual 30 (2nd Ed. 1990).

(2.) Supreme Beef Processors, Inc. v. U.S. Dep't of Agri., No. 00-11008 __F.3d__ (5th Cir. 2001).

(3.) A Threat to Meat Inspection [Editorial]. New York Times, Dec. 26, 2001, at A28.

(4.) Court Lessens Federal Power to Shut Down Meat Plants. New York Times, Dec. 17, 2001, at A13.

(5.) Redstone Water Co. v. Pennsylvania Pub. Util. Comm'n, 531 C.D. 2001 (Penn. Commonwealth Ct. 2001).

(6.) Crane Point Assoc., Inc., v. Florida Depart. of Health, #3D01-2110 (Fla. Ct. App. 2001).

Editor's note: Readers who have questions about cases discussed in Legal Briefs may contact Mr. Sikora by e-mail at <[e-mail]>.