tracts is being carried out. The public has been under a misunderstanding that the Renegotiation Act effectively eliminates excessive profits from such contracts.

(c) Hearings.-Hearing in 92d Congress was held on April 28, 1971. Transcript printed, entitled "Renegotiation Board Operations (Part 2)."

4. "Aircraft Collision Avoidance Systems." House Report No. 92–919, March 15, 1972.

(a) Summary.-The avoidance of midair collisions is one of the principal objectives of air traffic control. An effective collision avoidance system will necessarily include some type of airborne system encompassing all aircraft.

This report indicates that a collision avoidance system based upon a time frequency concept could probably be implemented within a few years, but that the high cost of this type of equipment would make it prohibitive for a large segment of the general aviation population. Other types of systems based upon different concepts are in various stages of development, but it has not been established that these systems will prove to be technically acceptable, if implemented on a nationwide basis. Although the Federal Aviation Administration (FAA) suggests that the collision avoidance problem might be substantially resolved through improvements in ground-based air traffic control systems, this would have severe limitations during the remainder of the 1970's due to inadequacies in FAA's air traffic control system.

Because of the absence of a national priority to overcome the economic roadblocks that hinder implementation of the time/frequency system, and the current and foreseeable inability of FAA to authoritatively evaluate alternative approaches, the report recommends that:

(1) The FAA research and development program should be organized to provide for a unified, coordinated approach encompassing all elements of air traffic control, including ground-based air traffic control, airborne collision avoidance, the structure of the Nation's airspace, as well as other related elements of the overall system:

(2) FAA should consider airborne collision avoidance and proximity warning capability as inherent elements in the overall air traffic control system, and not simply as backup devices to be used when ground-based air traffic control capability fails or is otherwise unable to provide for the safe separation of aircraft; and

(3) Included in this coordinated approach should be a reevaluation of the Nation's airspace structure, particularly in terminal areas, to determine the feasibility of limiting the collision problem through the separation of controlled and uncontrolled air operations.

(b) Benefits. The report is intended to encourage FAA to take a vigorous role in spearheading early implementation of an effective collision avoidance system. As the number of aircraft flying increases, the threat of a midair collision grows. Jumbo jets flying over populous areas constitute a potential for midair collisions that would result in a huge number of deaths. Forceful leadership now by FAA and other appropriate Government agencies could produce at an early date the collision avoidance system that is necessary to prevent such disasters.

Subcommittee followup indicates that FAA is making progress in regaining a position of leadership in the efforts to develop an effective avoidance system.

(c) Hearings.-Hearing held on August 3, 1971. Transcript printed, entitled "Aircraft Collision Avoidance Systems."

INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE

1. "Recall Procedures of the Food and Drug Administration." House Report No. 92-585, October 21, 1971. First Report by the Committee on Government Operations.

(a) Summary.-This report examines the Food and Drug Administration's use of the voluntary recall as a method of removing defective food and drug products from the market.

The report concludes that FDA has made excessive and improper use of recalls, which have increased tenfold in the past 5 years. By extending the use of the recall to products which are defective only in minor respects or which do not violate the law at all, FDA has reduced the public's protection from products which are health hazards or materially fraudulent. The excessive use of recalls has contributed to inadequate monitoring by FDA and ineffective and incomplete removal of seriously defective products from the market.

The committee reported that FDA was negligent in monitoring the recall of "Spice of Life Meat Tenderizer." This incident, involving the death of a man and serious injury of a woman in Washington, D.C., on March 14, 1971, illustrates the tragic consequences which may result from an inadequately monitored recall. The victims had consumed a quantity of poisonous sodium nitrite, mislabeled as "Spice of Life Meat Tenderizer," which had not been retrieved in an FDA-ordered recall 4 months earlier.

The report found that recalls have largely replaced the use of the statutory sanctions of seizure, injunction, and prosecution, with resultant loss of the deterring effect which Congress intended these sanctions to have. The report also found that FDA has been remiss in determining when to seize and when to recall a product.

(b) Benefits. The cost of monitoring recalls is being borne by FDA, but in the case of seizures and the detention of imported goods, the law authorizes the assessment of FDA's supervisory and monitoring costs against the owners or distributors of the products. Recall monitoring costs can be very large. For example, the cost to FDA for monitoring a recall in 1964 involving only one producer was $125,000. Recently FDA spent $39,000 for a night letter to hospitals and nursing homes in connection with the monitoring of a recall. The committee concluded that taxpayers should not be required to bear such costs when the manufacturer or distributor alone is responsible for the violations.

The report recommends that FDA study the desirability of statutory authority for the recall of violative products and for assessing against offenders the Government's cost of monitoring and supervising recalls. It is anticipated that substantial money savings will be realized either if the law is amended in this respect or if greater use is made of seizures in place of recalls.

FDA has advised the subcommittee that HEW is actively reviewing the need for legislation to facilitate the removal from the market of

products which present a potential hazard to the health of the

consumer.

FDA reports that it has taken the following additional actions in response to the committee's recommendations:

(1) A broad policy governing recalls has been developed and distributed to FDA's district offices. This policy is intended to provide uniform application of the recall procedures in all districts and thus to afford equal treatment to all parties involved. A headquarters monitoring system has been established to assure policy compliance.

(2) The "Regulatory Procedure Manual" has been revised to include the new recall procedures and guidelines.

(3) A recall has been defined as the action of choice where there is a definite threat or potential threat to consumer safety, or gross consumer fraud, requiring extensive removal of a faulty product from the market. Recall will not be utilized in dealing with minor violations, nor will its use preclude or supplant the application of legal sanctions.

(c) Hearings.-A hearing was held on March 29, 1971. The hearing transcript has been printed entitled, "Recall Procedures of the Food and Drug Administration."

2. "Regulation of Food Additives-Nitrites and Nitrates." House Report No. 92-1338, August 15, 1972. Nineteenth Report by the Committee on Government Operations.

(a) Summary.-This report examines the programs of the Food and Drug Administration and the Department of Agriculture for regulating the use of nitrites and nitrates as additives in meat and fish products.

In 1958, Congress passed the food additives amendment to the Food, Drug, and Cosmetic Act for the purpose of assuring that chemicals employed in or on foods would be subject to substantially the same safety requirements as apply to new drugs. Since this amendment became effective, thousands of chemical substances-including nitrites and nitrates have been approved by the Food and Drug Administration for food use. Many of these are quite toxic, and tolerances for their use have been established.

Nitrites are poisonous substances which can be injurious and even fatal, especially to children, when ingested in excessive amounts. Nitrates are not themselves very toxic, but can convert to nitrites both in the human body and in food. The potential danger of using nitrites and nitrates in food production has been greatly increased in the past few years by the discovery that nitrites in food may be chemically converted into extremely potent cancer-promoting substances known as nitrosamines.

Sodium and potassium nitrites and nitrates are used in cured meats, such as ham, bacon, corned beef, frankfurters, and luncheon meats, primarily to fix their red color and, in certain smoked fish, both for preservation and color fixation purposes.

The committee found a number of deficiencies in the administration of these programs, including the following:

(1) FDA and USDA have been concerned about the nitrite/ nitrosamine problem for several years, but they have made no serious effort to reduce the unnecessary exposure of the public to nitrites and nitrates as an interim measure until the question of the carcinogenicity of these additives has been resolved.

(2) USDA and FDA permit the concurrent use of nitrites and nitrates for color fixation and preservation of meat and fish. This practice results in the unnecessary and undesirable exposure of the consumer to nitrates which may convert in the human body to nitrites.

(3) The maximum amount of nitrite-200 parts per millionpermitted by USDA and FDA regulations in meat and fish is based on past usage rather than on adequate scientific evidence.

(4) FDA knowingly allows 30 percent more sodium nitrite in smoked chubs (a small lake fish) than is permitted by the agency's regulations.

(5) Although FDA has repeatedly found samples of nitrited chubs containing substantially less nitrite than the amount_required to prevent the development of botulism, FDA has taken no regulatory action to remedy this situation.

(6) FDA has no effective surveillance and enforcement program to assure industry compliance with its limitation on the use of nitrite.

(7) FDA and USDA permit the use of nitrites as preservatives in food, but do not require that product labels disclose these additives as required by law.

(8) An added potential health danger has arisen from the recent discovery that several widely used drugs readily combine with nitrites to form potent cancer-promoting nitrosamines. The FDAapproved labeling and advertising for at least one of these drugs (tolazamide) recommends that it be taken once daily at breakfast, the very time when foods containing nitrites, such as bacon, ham and sausage, are customarily eaten.

(9) FDA's and USDA's expressed concern about botulism does not justify the failure of these agencies to take protective action against the excessive or unnecessary use of nitrites and nitrates. No substantial evidence was produced in the subcommittee's hearings to support the contention that nitrites are essential for the prevention of botulism except in a limited number of situations. The committee made eight specific recommendations for correcting the deficiencies disclosed in the report.

(b) Benefits.-The subcommittee's investigation and the report have produced a greater effort by the FDA and the USDA to strengthen their regulation of the food additive uses of nitrites and nitrates. Both agencies have reported that they are amending their food additive regulations in order to eliminate the needless use of nitrites and nitrates. USDA has agreed to require that food product labels disclose the presence of nitrites and nitrates as preservatives. And, the FDA and USDA have both indicated enthusiastic support for the committee's recommendation that they conduct vigorous educational programs to instruct home canners of food on proper canning methods for the prevention of botulism.