We know that the vaccines and others of these products have done a tremendous job.

If we would have had to comply with the May 1970 FDA efficacy requirements, or if we would have had to have them meet a certain predetermined test, these products would not be marketed. That is why we say before you move full steam ahead on new requirements of proof, that at least let us have an opportunity to sit down and discuss the difficulties it will create.

Now, DBS has required, with respect to 30-some products, that within a 30-day period, which has passed as of April 15, the companies that marketed the products had to declare their intention to submit "adequate" data within 180 days. If they didn't so state, the license, and these are licensed products, would be revoked.

The firms that said yes, that will try to comply with the efficacy requirements, have 180 days in which to produce that proof. On many products that is an absolute impossibility. Hopefully in the 180 days we will be able to sit down and have a reasonable discussion as to whether these proposed standards are too tough, in the hope that some of these products which are quite effective can be retained on the market.

That is really what we were trying to do-to enter into a reasonable discussion with DBS in the correspondence, not to say you can't do it.

LEGAL AUTHORITY

We didn't raise the legal issue. There is a legal point that DBS has contended for 20 years; that there is no legal authority for them to check efficacy. We didn't really go into that point extensively because the General Counsel of HEW has ruled that the authority that FDA has carries over under the food and drug law to DBS. We are not in a contest on that point. We really want to make sure that the tests they require can be met and that some of the products which are extremely good just don't go off the market.

Senator HARRIS. Thank you, Mr. Stetler and Mr. Brennan.

Our final witness for this morning is Miss Judy Jackson with the Public Interest Group here in Washington.

We are glad you are here. We will be pleased to hear from you.

TESTIMONY OF JUDY JACKSON, PUBLIC INTEREST RESEARCH GROUP, WASHINGTON, D.C.

Miss JACKSON. Thank you very much, Mr. Chairman and distinquished members of the subcommittee.

Incidentally, I would like my full statement to be included in the

record.

Senator HARRIS. Without objection, that will be done.

(See exhibit 6. p. 160.)

Miss JACKSON. Thank you for providing me with the opportunity to express my views on S. 3419, the Consumer Safety Act of 1972.

I am Judy Jackson, a law professor currently on leave from the University of Toledo College of Law and associated with the Public Interest Research Group in Washington, D.C. That is one of Ralph Nader's groups. I have been specializing largely in monitoring the

Food and Drug Administration, but with particular emphasis on product safety.

TWO BASIC ISSUES

The following basic issues face this subcommittee as it considers titles I and II of S. 3419:

1. Should the Consumer Safety Agency be an independent agency. as provided in section 102, or should the new regulatory authority provided by title III over consumer products be placed in a "reorganized FDA" called the Consumer Safety Administration within HEW?

2. Does the proposal for an independent Consumer Safety Agency conflict with the bills for an independent Consumer Protection Agency now pending before this committee? Also, is an independent safety agency consistent with proposals for a new Department of Health introduced by Senator Ribicoff on March 29, 1972, and cosponsored by four Senators who approved S. 3419?

(1) The Consumer Safety Agency must be an independent agency, as provided by section 102 of S. 3419

The Senate Commerce Committee report contains an excellent statement of reasons as to why the Consumer Safety Agency should be an independent agency.

The committee report relies on the conclusion of the National Commission of Product Safety that "when a Federal agency must take up substantial and controversial issues of consumer safety and economics, we believe it must have independent status".

WEAKNESSES IN PRODUCT SAFETY PROGRAMS

This conclusion was based on the Commission's analysis of the weaknesses in existing product safety programs: lack of adequate funding and staffing because of competition with other deserving programs within an agency; lack of vigor in enforcing the law caused by an absence of authority and independence of some Federal administrators; and a low priority assigned to programs of low visibility.

The latter point, I think, was discussed at great length yesterday, particularly by Mr. Elkind.

The committee report also noted that at hearings before the committee, consumer organizations generally supported the bill creating an independent commission. The committee report contains an excellent statement of the interrelationship between making the Federal Government responsive to its mission to protect consumers against unsafe products, the independence of the agency, adequate funding, visible decisionmaking based on public availability of information, and the need to subject agency inaction to judicial review through an expanded mandamus action. The committee report states at page 8:

There is an urgent need to make the Federal Government responsive to its mission to protect consumers against unsafe products. Independence is a crucial element in fulfilling such a need. An independent agency with publicly accountable decision makers is able to make determinations as to which products present unreasonable risk of injury or death unfettered by political dictates, self-interested industry pressure, or blind consumer zeal.

Independence alone, however, does not automatically assure responsiveness to the legislative mission. As mentioned above, the agency must be adequately funded and staffed. It must also make visible decisions based upon input from

all constituencies. In other words, both consumer and industry points of view must be made publicly known to the decision maker, and the public accountability for the decision must be placed upon the person actually making it. A prerequisite to meaningful participation in Agency activities by both consumer and industry groups is availability of information.

It is therefore important that the Agency make accessible to interested persons reports, documents, communications, studies and all other materials (other than competitively harmful information) which would enable them to monitor and participate in all proceedings in an informed manner.

There is a final need to insure the responsiveness of the government to its product safety mission. In addition to the judicial review of Agency action, there is a need to subject Agency inaction to judicial review through the mandamus process. Unfortunately, the false distinctions created by the thaumaturgical words "ministerial" and "discretionary" presently impose limitations on mandamus in needed areas. For example, the determination of which products present unreasonable risk of injury or death is "discretionary" and therefore not subject to mandamus. But this is the very area of decision making which should be reviewable if the Federal Government is to be responsive to its mission of protecting consumers against unreasonable risk of injury or death. Therefore, it is necessary to limitedly expand the mandamus action so that it can reach into certain carefully defined discretionary areas.

STATUTORY AUTHORITY

In contrast to the position of consumer organizations, the National Commission on Product Safety and the Senate Commerce Committee, business organizations and the administration have generally argued that new statutory authority over unsafe products should be placed within HEW in a "reorganized FDA" called the Consumer Safety Administration, composed of an Office of Product Safety Regulation, an Office of Drug Regulation, and an Office of Food Regulation.

The publicly stated reasons for this position-I think you had a good example of them this morning, with paeans to good government, to efficiency, to agency expertise and so forth-are that the functions to be vested in the independent agency are an "integral part" of the responsibility of HEW, and separating this function from the department "would deprive the Agency of the many and varied services and expertise available with the Department"; and that "creation of an independent Agency would add to the proliferation of bureaucracy, a situation which the President is seeking to correct." Behind these smooth words lies the real reason why the administration and business oppose an independent and open agency administering a comprehensive Product Safety Act-they realize that S. 3419 means an end to business as usual, in which regulations, on the basis of weak piecemeal safety legislation, sit down with the regulated in the quiet of their offices and attempt to cajole industry into voluntary compliance.

Business realizes that under S. 3419, regulators will be hearing from consumers on a regular day-to-day basis. The administration realizes that if in response to consumer demand it actually begins to enforce S. 3419, it may strain the "delicate balance" with industry on which depend not only political contributions, but also opportunities for subsequent employment with the regulated.

PRODUCT SAFETY-GOVERNMENTAL RESPONSIBILITY

The complexities of governmental organization presented by S. 3419 should not blind this subcommittee to the critical substantive issue

involved in S. 3419: The recognition that product safety has become primarily a general governmental responsibility in the wake of the failure of self-regulation by industry.

To put administration of such a law within a reorganized Food and Drug Administration whose operating philosophy has been that the manufacturer has primary responsibility for the safety of his products, and the Federal role is to encourage voluntary standard setting will make a mockery of the law.

VOLUNTARISM

That "voluntarism" is the operating philosophy of the FDA becomes clear whether one looks at its older branches, Foods and Drugs, or its new branch, the Bureau of Product Safety.

I cite at least one recent example from each bureau. In the wake of the Campbell Soup and Bon Vivant episodes, and the questions raised about the adequacy of Federal inspection, Commissioner Edwards has announced plans for FDA to "meet its regulatory obligations" by "shifting emphasis from inspection of food processing to inspection of management of food processing-quality control-and permitting processors with acceptable quality control programs to enter the selfcertification program and qualify for minimal FDA attention".

Representative Bingham of New York, while generally concurring with the Commissioner that inspection of quality control systems and records would encourage more meaningful analysis of the nature of food processing in this country, noted, as he introduced his Pure Food Act of 1972 that " as proposed by the Commissioner, this reform promises to be very limited. The FDA has no authority to compel food manufacturers to present quality control information."

He interpreted the Commissioner's proposal and his reliance on voluntary arrangements as "an expression of inherent weakness in FDA's regulatory scheme *** In the absence of power, the FDA has decided to bargain for cooperation with food companies *** I think this is the critical point-"Further, by bargaining without real power, the FDA runs the risk of becoming the tool of the industry it is designed to regulate and perpetuates the sham of adequate. control."

Representative Bingham noted that less than 20 food companies were participating in the voluntary program.

The FDA's continual reliance on voluntary regulation, even in the face of industry noncompliance, is illustrated very well in the recently proposed OTC drug program and the final "voluntary regulations" on cosmetics.

Commissioner Edwards admitted in testimony before the Senate Appropriations Committee on March 29, 1972, that the pharmaceutical companies' response to FDA's voluntary drug inventory program had been "less than we would like-there is a reluctance by the drug industry to give us information."

He argued that drug listing legislation was absolutely essential and observed that the FDA's OTC drug review program would be impossible to complete until FDA got a listing of who manufactures what drugs.

However, his memory about the failure of one voluntary program is apparently very short. On March 31, 1972, 2 days after the above testimony, Commissioner Edwards signed the final FDA regulation for voluntary registration of cosmetic product establishments and voluntary filing of cosmetic product ingredient statements.

He stated his conclusion that "promulgation of a mandatory regulation could result in lengthy litigation that would seriously delay FDA from obtaining the type of information expected as result of this promulgation."

Unstated was any analysis of why Commissioner Edwards concluded cosmetic manufacturers would cooperate with voluntary regulations, when drug manufacturers would not.

As for the Bureau of Product Safety, its approach to "voluntarism” is well illustrated by two recent incidents.

LEAD TINSEL CASE

First, in the lead tinsel episode detailed by Senator Joseph Montoya in the March 22, 1972, Congressional Record, the Bureau of Product Safety, by late March 1971, had received letters from a pediatrician at Johns Hopkins and the New York State commissioner of health recommending that FDA declare lead tinsel a "banned hazardous substance" under the Federal Hazardous Substances Act.

Instead of exercising Federal regulatory power under the FHSA, Malcolmn Jensen, Director of the Bureau of Product Safety, held a secret meeting with all domestic manufacturers of lead foil icicles in August 1971, at which, according to letters from several of the manufacturers published in the Congressional Record, Mr. Jensen requested voluntary withdrawal of lead foil icicles by Christmas 1972 in return for a commitment by the Bureau not to give this information to the news media or "inflict a banning order" until after Christmas 1972.

The decision had the effect of providing the manufacturers with two additional selling seasons for lead tinsel, Christmas 1971 and Christmas 1972, and incidentally, since part of the agreement or deal was that FDA get Customs to ban imported lead icicles after Christmas 1971, the domestic manufacturers were presented with a real windfall and chance to really clean up for the 1972 Christmas season.

One letter quoted Mr. Jensen as stating at the meeting "that in order to mitigate economic loss to be suffered by manufacturers, the agency would not initiate or give any publicity to the voluntary agreement on the alleged dangers from lead icicles until the conclusion of the 1972 Christmas season." It is difficult to imagine a more blatant example of a Federal agency's placing the economic problems of a manufacturer above the public health.

ELECTRICALLY OPERATED TOYS

Second, the Bureau's recently proposed standards on electrically operated toys further illustrates its continued reliance on industry voluntary standards, even in a situation where the Bureau has clear statutory authority and the duty to develop its own standards.

The proposed standards are generally little more than a paraphrase of UL (Underwriter's Laboratory) 696. Thus, what the Bureau has

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