seizures are not always determined to be the preferred course of action when noncomplying consumer commodities are encountered. Hundreds of warning letters have been issued to industry by our field District offices and have proved quite effective in obtaining corrections without the need for formal seizure. In addition, this Agency has been as active as its resources will permit in educating industry in all phases of compliance with the FPLA. We hope that these educational efforts will promote voluntary compliance and minimize the need for formal regulatory action.

In its administration of the FPLA, FDA has sought and received the active cooperation of State authorities in accord with provisions in section 9 of the Act. Close cooperation with the States in the promulgation of regulations has been especially important because FPLA supersedes any and all State laws that "provide for the labeling of the net quantity of contents of the package of any consumer commodity covered by this Act which are less stringent than or require information different from the requirements of section 4 of this Act or regulations promulgated pursuant thereto."

To assist State authorities and promote uniformity in enforcement, the FDA prepared a manual for State officials which includes FDA requirements and important interpretations. Later a revision of this manual was made available to interested trade associations and members of industry to facilitate compliance and promote uniformity in the labeling of foods, drugs, devices, and cosmetics.

Under section 5 of the FPLA, regulations may be promulgated, when needed to prevent deception or facilitate value comparisons, to: (1) establish standards for the manner in which sizes are described, such as "king size," "family size," or similar descriptive terms; (2) control use of label statements which imply that a commodity is offered for retail sale at a price lower than that ordinarily and customarily charged; (3) require that other consumer commodities be labeled, like foods, with the common or usual name and list of ingredients; and (4) prohibit nonfunctional slack fill of packages. The FDA is authorized to promulgate such regulations covering foods, drugs, devices, and cosmetics. The Federal Trade Commission is responsible for regulations concerning other consumer commodities.

In May 1970, both the FDA and the FTC published proposed regulations intended to protect consumers against misleading or confusing claims or implications that a commodity is being offered for retail sale at a price lower than ordinarily and customarily charged. Both proposals dealt with "cents off" representations; the FDA proposal also covered "economy size" claims. The FTC proposal concerning "economy size" claims was published November 24, 1970. Both agencies have tried to reconcile differences in their respective proposals so that final regulations may be as uniform as possible and thus provide common terms and general requirements that both industry and the consumer can understand as applying to all kinds of products, regardless of which agency has jurisdiction. Differences in

regulatory authority, established procedures, and enforcement capabilities may result in final regulations which are not exact duplicates. However, there will be uniformity in their major provisions.

In a recent action to finalize the previously proposed "cents off" and "economy size package" regulations, the Food and Drug Administration published an order in the Federal Register of June 30, 1971. As is provided for in such rulemaking, interested parties used the opportunity to respond to the regulation. These responses, consisting of opinions, requests for clarification, and objections to certain provisions, are being evaluated and a decision will issue shortly. An effective date of December 31, 1971, was set for these regulations, but this date is not inflexible and is subject to modification by the Commissioner of Food and Drugs should circumstances warrant.

Over the years the FDA has consistently received complaints from irate consumers about the slack filling of packages. Despite Section 403(d) of the Food, Drug, and Cosmetic Act which deems a food to be misbranded if its container is so made, formed, or filled as to be misleading, the FDA was notably unsuccessful in coping with this problem. In each contested case of alleged slack filling brought under this FDC Act section, the Federal courts exhibited a reluctance to consider a package to be nonfunctionally slack filled if its label carried an accurate declaration of the quantity of contents.

In view of FDA's inability to deal with the continuing allegations of slack filling received from consumers, the enactment of the Fair Packaging and Labeling Act, specifically authorizing this Agency in Section 5(c) (4) to issue regulations to prohibit nonfunctional slack fill, was hailed as a golden opportunity for a fresh approach to a problem that began with the first packages.

The previous decisions of the Federal courts emphasize the need for clearly demonstrating the extent to which the space not occupied by the consumer commodity in the package is functional, that is, necessary to protect the integrity of the product; or nonfunctional to the extent that the consumer may possibly be deceived. Simply stated, where in the packaging of a product is the line to be drawn that distinguishes functional from nonfunctional? How full must a package be? How much settling of the product is unavoidable, even in the most carefully controlled manufacturing and filling operations? To answer such questions the Food and Drug Administration launched an extensive survey to find out more about the magnitude and extent of the problem where it was most apparent to the consumer-the retail marketplace. Six broad categories of packaged foods were selected for the retail survey. These were products which have a significant place in the American diet or which are the basis of recurring complaints about slack filling. They were macaroni and noodle products; dry cereal and grain products; candy; loosefilled crackers, cookies, etc.; dry cake mixes; and dry desserts. To assist us in this extensive informationgathering operation, we enlisted the services of many State regulatory agencies through cost-reimbursable

contracts. This project ushered in a new and innovative era of State-Federal cooperation for the Food and Drug Administration.

For the 1971 fiscal year, contracts were negotiated with 11 States: Alabama, Idaho, Florida, Maryland, Minnesota, Missouri, Oklahoma, Pennsylvania, Texas, Washington, and Wisconsin. These contracts provided for State authorities, in accord with detailed FDA instructions, to collect and examine consumer packages of selected foods to obtain data concerning (a) slack fill and (b) package size characterization as related to net contents. The findings were to be reported each month to FDA.

Under these contracts, State authorities collected and examined more than 10,000 samples. The data from this survey has been assembled but has not yet been organized and analyzed. Therefore, broad conclusions concerning interpretation of results are not possible at this time.

But even a casual scanning of the raw data concerning percentage of package fill brings to light some striking contrasts and raises some interesting questions. In many of the samples of breakfast cereals made from wheat, rice, and oats, packages were full or almost full, but in other samples the packages were far from full. Some packages of rice breakfast foods were only about two-thirds full; some packages of wheat breakfast foods were less than half full and one was only slightly more than one-fourth full. In one sample of oatmeal the packages were only a little over half full. During the survey it was noted that one breakfast food manufacturer had voluntarily reduced the size of a container by almost six cubic inches without any change in the quantity of contents.

Even greater variations were found in the fill of macaroni and spaghetti products. In many samples the packages were filled or almost filled; in other samples packages were only half filled, and in a few instances the food occupied as little as one-fifth or less of the available space. In many of the samples of cookie mixes, pudding mixes, and other prepared mixes, the packages were found to contain only one-half to twothirds as much as they could hold. Some packages of candy, including hard candies and licorice as well as more fragile chocolates, were found only about halffilled. Whether the slack fill in these packages is functional or nonfunctional will call for thorough investigation.

The State authorities also check the net weights of the samples examined. They found that in about 7 percent of the samples the net weight was 1 percent or more below the declared weight. Each of these has been reported to the FDA District in whose territory the manufacturer is located for appropriate corrective action by the District or State officials.

Over 800 food product labels were found to bear various descriptions of size. Some carried one size designation for such a wide range of package sizes of the same food that it would make value comparisons difficult, and would certainly be confusing. For instance, one food was sold in 5, 7, 8, 9, 10, 11, 12, 13, 15, 16,

18, 20, and 42-ounce packages, all described as "large size." Other size designations were more imaginative than informative. Among these were "Jug Size," "Ketchup-Lovers Size," "Coffee-Lovers Size," "Tribe Size," "Pass-around Size," "Patio Size" and "Fun Size."

The new venture in State-Federal relations proved beneficial to all concerned. FDA obtained the information it needed; the State agencies were able to employ and train more people, and to enter new areas of regulatory activity. Both Federal and State agencies will benefit from the better communications and working relations that evolved as they joined in this common endeavor.

The operation was so successful that it is being continued in fiscal year 1972. Contracts have been negotiated with 10 States to conduct another retail survey, this time to: (1) ascertain the impact of the FPLA in the marketplace, to determine the level or extent of compliance, and, when violations are found, to initiate corrective actions through State agencies or the FDA; and (2) to determine what representations are being made on labels concerning cost savings, to find whether the promised savings are actually passed on to consumers, and, if not passed on, to estimate the loss to consumers. This survey includes cosmetics as well as foods. It is too early to predict the results, but already the State agencies are finding many cosmetic packages and some food packages that do not comply with the FPLA. Appropriate regulatory action will be taken against violative lots by State or FDA officials.

Food labels now provide consumers information about what food is in the package, who makes or distributes it, and how much the package contains. Regulations are being developed that will provide consumers further protection against confusing characterizations of package size, false and misleading promises of savings through the use of "cents off" or "economy size" claims, and packages that deceive. In the process, FDA has pioneered the use of costreimbursement contracts that have benefited State agencies and developed information needed by this Agency.

The work that is being done to implement the Fair Packaging and Labeling Act gives promise that the will of the people in seeking this important legislation and the intent of the Congress in enacting it will be fulfilled in way that is both advantageous to consumers and fair to industry.

L

REAL

ast August 14 a picnic was held in Maryland at which 550 guests attended. It was a feast of Chesapeake Bay steamed crabs, a regional delicacy that has been esteemed by Marylanders since colonial days. Some 16 hours later, 320 of the picnickers became ill with symptoms such as diarrhea, severe abdominal cramps, nausea, vomiting, fever, headache, and chills. A number of the affected people were hospitalized.

Two days later, at a much smaller picnic, 20 out of 30 guests developed a similar illness from eating steamed crabs. The symptoms of the smaller outbreak were identical with those of the first. No death occurred in either outbreak.

Maryland State Health Department officials found that crabs from the same batch were distributed to both picnics. Maryland Department of Health and FDA laboratories examined crabs obtained from one of the picnics and also stools from several ill persons. The usual expected enteric pathogens such as Salmonella or Shigella were not found in the stools or the crabs. Instead an organism known as Vibrio parahaemolyticus was found. This organism is known to be an important cause of foodborne disease in Japan, but it has never been identified with outbreaks in the United States.

The analyses and investigations by the State of Maryland and FDA were sufficient to establish for the first time on record that V. parahaemolyticus was responsible for outbreaks of disease in this country. Equally as important to public health in the United States, the findings supported and gave immediate relevancy to the concern of FDA and other public health agencies over the past several years that the microorganism posed a potential threat to public health in this country.

Vibrio parahaemolyticus has been recovered from all parts of the marine environment, including seafood products, both in waters that are polluted and waters not known to be polluted. It has been found in samples taken from practically all major bodies of marine water surrounding the United States. It thrives better in warm weather than in cold and the illnesses it causes are usually associated with warm weather. It is killed by thorough cooking.

Until the outbreaks in Maryland in August, the only instances of illness to be reported as due to Vibrio parahaemolyticus had been in Japan. The first outbreak of disease for which Vibrio parahaemolyticus is known to have been responsible occurred in Osaka, Japan, on October 21-22, 1950. Of the 272 victims

who developed an acute gastroenteritis after eating "shirasu" (boiled, semidried sardine larvae), 22 died. Autopsy specimens yielded an organism that Dr. Tsunesaburo Fujino, in describing the outbreak the next year, named Pasteurella parahaemolyticus. Subsequently, numerous similar outbreaks occurred and the organism underwent several redesignations. Finally, in 1963, Dr. Riichi Sakazaki of the Japanese National Institute of Health and others suggested the name Vibrio parahaemolyticus after a definitive study of many cultures. The name has been widely accepted throughout the world.

Vibrio parahaemolyticus is an enteropathogenic, gram-negative, curved, rod-shaped, facultative microbe, and the most favorable condition for its growth is in a medium containing 2-4 percent salt. It particularly favors alkaline conditions and multiplies rapidly at 37° centigrade. It appears to be able to live in marine waters without an animal host. It has been found in coastal and estuarine waters and sediments and on marine fish, crustaceans, and shellfish in many areas of the world, including all coastal waters of the United States. It is believed to be universally distributed in the marine environment.

Outbreaks of food poisoning caused by this organism in Japan have usually followed the eating of raw seafoods and other contaminated products. Outbreaks occur commonly in Japanese coastal areas, and the high incidence there is undoubtedly due to the national custom of eating raw fishery products. The symptoms of the disease usually occur within 15-17 hours after eating and include violent epigastric pains, nausea, vomiting, and diarrhea. Fever, headache, and chills may occur, along with mucus and blood in the victim's stools. Symptoms usually subside in one or two days. The number of recorded cases in Japan is high-ranging from 10,000 to 14,000 a year-and accounts for 40 to 70 percent of all reported illnesses in that country from bacterial causes. American travelers returning from the Orient have contracted the disease and a number of cases have involved American military personnel serving in the Orient. Vibrio parahaemolyticus was suspected in two outbreaks of gastroenteritis in Seabeck, Washington, reported in "Foodborne Outbreaks-Annual Summary, 1969," published by the Center for Disease Control.

When public health officials in this country began to evaluate reports of the many outbreaks of foodborne disease in Japan associated with Vibrio parahaemolyticus, there appeared to be no cause for great concern