The big problem, as I mentioned, is in the feed. If the feed is contaminated, this gets back into the flock, and the flock will recontaminate itself, so that until there are measures to control the purity of the feed, it is difficult to wipe out salmonellosis. Senator YOUNG. Thank you. That is all, Mr. Chairman. Senator JORDAN. You spoke a minute ago about feathers and offal being resold for feed. Are they precooked? Dr. SENCER. In some instances they are. But the problem is that you start with a contaminated product, you start with a feed and perhaps it is sterilized at that time but then the environment of the processing plant is such that it can become recontaminated in the process of being stacked and shipped. Unless you have good sanitation around the processing plant, for the disposal of refuse and the like from the plant, there is a good opportunity for this to come about. An investigation in the fish meal has shown that you can start with the contamination product, and you can clean it up in the process of preparing it to be sold, but then as it is packaged and stored it can become recontaminated. Senator JORDAN. What is checked shell eggs? Dr. SENCER. These are cracked eggs, where the shell is cracked, broken. Senator JORDAN. It is cracked? Dr. SENCER. Yes, sir. Senator JORDAN. I can see where they would become contaminated. Thank you very much, Dr. Sencer. We appreciate your being with us. We appreciate your testimony. Dr. SENCER. Thank you. Senator JORDAN. Our next witness is Mr. Dunkelberger, on behalf of the National Canners Association. We are glad to have you with us. You have been before this committee before. We are glad to have you back again. STATEMENT OF EDWARD DUNKELBERGER, ON BEHALF OF THE Mr. DUNKELBERGER. Mr. Chairman and members of the subcommittee, my name is Edward Dunkelberger. I am a member of the firm of Covington & Burling and am appearing today on behalf of the National Canners Association, a nonprofit trade association whose almost 600 members, having canning plants in 44 of the 50 States, pack approximately 85 percent of our national production of canned fruits, vegetables, meats, seafoods, and specialties. The members of the National Canners Association who pack canned poultry products have been fully subject to the requirements of the Federal Poultry Products Inspection Act ever since it became effective after enactment 10 years ago. Canned poultry and poultry products are prepared from federally inspected poultry, are packed under continuous Federal inspection, and are distributed widely in interstate and foreign commerce. Indeed, the canning industry supported the enactment of the Poultry Products Inspection Act in 1957, as it has many other Federal laws designed to assure that consumers will receive a safe, wholesome, and truthfully labeled food supply. There can be no dispute as to the salutary effects of the Poultry Products Inspection Act for consumers, manufacturers, and producers, nor can there be any question that requirements equivalent to those imposed under the Federal act should be applicable to all poultry and poultry products sold for human consumption in this country. The National Canners Association endorses and supports the enactment of Federal legislation that will achieve that purpose. We believe that H.R. 16363-recently passed by the House-would be an important and effective step in consumer protection, and that at the same time it would protect those companies now under Federal inspection against the possibility of unfair competition from purely intrastate firms. The canning industry also strongly endorses those provisions of the bill that will prevent the sale of imported poultry products not produced in accordance with the requirements of the Federal act. Senator JORDAN. There was some discussion about poultry products being imported-not a great deal, but there was quite a large quantity of canned poultry and turkey also being imported into this country. Mr. DUNKELBERGER. I am not familiar with the figures on that. It is my understanding that there is some volume of such canned products being imported, but I have no idea to what extent it has been taking place in terms of figures. Senator JORDAN. Do we have any control over the purity or quality of these imports? Mr. DUNKELBERGER. It is my understanding: No. 1, that the existing act was intended to apply and does apply to those products imported into this country. They are poultry products subject to the jurisdiction of the Poultry Products Inspection Division of the U.S. Department of Agriculture, and I would assume that the plants in which those canned products have been processed abroad are subject to the same requirements that the Department imposes upon plants abroad that might pack other poultry products to be shipped into this country. I think, inevitably, you get the question of whether the inspection program abroad is as effective as the continuous inspection here in this country, but on the assumption that the certification by the USDA-and I believe only two or three countries have been certified to ship poultry products into this country-is meaningful, those products are probably generally as good as the domestic products. Senator JORDAN. I believe we had testimony that sample cans are opened for analysis and a microscopic examination, et cetera, to detect salmonellosis and other diseases. Some of these products have been confiscated and have not been allowed to be sold. Mr. DUNKELBERGER. They do sample food imports wholly apart from any certification of the foreign inspection system. They do sample all imports of all food products, it is my understanding—that is, a certain percentage of them. Many people question whether the percentage should be higher. I know that in the fish legislation in which we are concerned, we feel that it should be significantly higher. I am not aware that the industry feels that it is a problem from imported chickens and turkeys. Senator JORDAN. I just wanted to have that information as to the canning situation. Thank you very much. Mr. DUNKELBERGER. Yes, sir. RRA. While the National Canners Association supports H.R. 16363, we would like to urge upon this Committee the adoption of a few-but we believe vitally important-amendments. These concern three aspects of the bill that have received little attention or interest, but which raise, we submit, substantial problems of legislative intent, public policy, and constitutional limitations. RULEMAKING PROCEDURE The Poultry Products Inspection Act does not now, nor would it after enactment of H.R. 16363, provide for hearings and a record in the event of disagreement as to the wisdom or propriety of any of the many kinds of administrative regulations promulgated under the act. There is no requirement that such regulations be based upon substantial evidence, nor is there any provision for findings, indeed, for any record, upon which judicial review can be sought if necessary. The Department need do no more than publish a proposal and provide an opportunity for written comments. The requirement for a hearing, at which the officer who desires to promulgate detailed regulations must appear and present for the record the facts upon which their need and reasonableness is based, is an important and now well-established procedural safeguard for the adoption of regulations that will have the force and effect of law. Where Congress deems it to be necessary and in the public interest to delegate to an administrative agency the formulation of substantive regulations, it has in recent years recognized that such delegation of its legislative power must be accompanied by at least minimum procedural safeguards for those who will be governed by the regulations. The Federal Food, Drug, and Cosmetic Act of 1938 contains a carefully considered procedural framework in section 701 (e), (f) and (g), which provides for public notice of rulemaking, an opportunity for comments by interested persons, and the publication of a regulation after consideration of these comments. If a person who is adversely affected by the regulation objects within 30 days and demands a hearing, a hearing will be held if the objection raises factual issues. Any interested person may appear at the hearing and present evidence. The final regulation must be based on substantial evidence in the hearing record. Judicial review is provided for any person adversely affected by the final regulation. This procedure has proved to be beneficial and workable for all concerned. It applies to the promulgation of food standards, food and color additive regulations, drug regulations, pesticide regulations, and dietary regulations. In 1966, it was incorporated by Congress in the Fair Packaging and Labeling Act and has provided a basis for the promulgation of regulations that are in the public interest with a minimum of procedural redtape. Its principal advantages are that although it provides adequate protection to those who will be adversely affected by a regulation, it also has flexibility, so that a hearing will actually be held only if a dispute arises on a relevant issue of fact. We propose that this section 701 procedure be incorporated into H.R. 16363. A provision along the following lines could be added as a new section of the act: Regulations promulgated by the Secretary under sections 4(g) (2) (D), 4(h) (10), 4(h) (12), 8(a), 8(b), 11(b) and 14 (a) of this Act shall be promulgated and shall be subject to judicial review, pursuant to the provisions of subsections (e), (f) and (g) of section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e), (f) and (g)). Hearings authorized or required for the promulgation of any such regulations by the Secretary shall be conducted by the Secretary or by such officer or employee of the Department of Agriculture as he may designate for that purpose. We should emphasize that in making this proposal the association does not suggest capriciousness on the part of the Secretary in promulgating regulations. The point is that so long as the central purpose of this bill is to modernize Federal law with respect to poultry and poultry inspection, modern procedural safeguards should also be incorporated. These procedures have proved workable in other Federal laws, and have enjoyed wholehearted support not only from private parties but from the agencies and commentators as well. There is every reason to believe that the administration of the new act can be accommodated to these modern administrative procedures. Senator JORDAN. In the middle of page 4, you have the regulation to be promulgated by the Secretary under section 4(g). Is that what you would like to have incorporated? Mr. DUNKELBERGER. Yes, sir. I might add that that language had the effect of making applicable the procedures in the Federal Food, Drug, and Cosmetic Act. This language is based on similar language in the Fair Packaging and Labeling Act which is also incorporated by reference. The matters to be covered by that regulation are our conclusions as to which rules ought to be adopted, and are authorized under the Poultry Act; and, to be adopted under this procedure. It is conceivable that people might differ as to which particular rules would be covered, but we believe these are the substantive rules authorized by the act which will have the force of law in the sense of rule-making or law-making, and should be subject to this provision. Senator JORDAN. Thank you, sir. Are there any questions at this point on that particular part? Mr. DUNKELBERGER. Returning to my paper and picking up with the subject of access to company records: pertinent labeling th The leg Another provision of the bill that concerns us is section 11 (b), which provides that companies regulated by the act would be required to keep such records as are properly necessary for the effective enforcement of the act, and to afford to representatives of the Secretary of Agriculture access to their places of business and opportunity to examine the facilities, inventory, and records thereof. The section goes on to authorize the Secretary's representative to copy all records and to take samples of inventory upon payment of their fair market value. it clear th to be whol not exten metic com authority Of ever spection June 1967 City and amendme tends to This extremely broad inspection authority may be contrasted with the language of section 704 of the Federal Food, Drug, and Cosmetic Act which provides for the inspection of all plants producing food for shipment in interstate commerce. As amended in 1953, this section authorizes FDA investigators to enter at reasonable times, any factory, warehouse or establishment in which foods are manufactured, processed, packed, or held for introduction into interstate commerce, and to inspect at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse or establishment and all erty. In compulso ness pro unless he We the portions o compelled rant proce pertinent equipment, finished and unfinished materials, containers and labeling therein. The legislative history of the 1953 amendments to section 704 made it clear that this inspection authority, which was deemed by Congress to be wholly adequate for the protection of the public, need not and did not extend to the documents, records and files in food, drug and cosmetic company plants and offices. In 1962 limited records inspection authority was enacted for prescription drug plants. Of even greater significance to Congress's consideration of the inspection provisions of H.R. 16363 are the Supreme Court decisions of June 1967 in See v. Seattle and Camara v. The Municipal Court of the City and County of San Francisco, in which the Court held that fourth amendment prohibition against unreasonable search and seizure extends to governmental inspections of residential and commercial property. In those decisions the Supreme Court condemned warrantless compulsory inspection of business establishments and held that a business proprietor can legally refuse to admit a Government inspector unless he is armed with a search warrant. As the Court stated in See: We therefore conclude that administrative entry, without consent, upon the portions of commercial premises which are not open to the public may only be compelled through prosecution or physical force within the framework of a warrant procedure (387 U.S. at 545). There can be no question that these cases-decided less than a year ago have direct application to Federal statutes authorizing food plant inspection. The FDA issued a press release shortly after the Court's action stating that the decisions called for abrupt change in its inspection procedures. Food and Drug inspectors were instructed to apply to U.S. district courts for inspection warrants whenever owners or managers of business plants refused to consent to an inspection voluntarily. Indeed, the United States Court of Appeals for the Third Circuit has already held that Camara and See are fully applicable to the FDA's inspection authority under section 704, and that the fourth amendment as interpreted in these Supreme Court decisions applies to business records. United States v. Stanack Sales Co., Inc., par. 40 284 Food, Drug, and Cosmetic Law Reports (3d Cir. Jan. 5, 1968). In spite of the fact that section 704 grants FDA access to certain prescription drug plant records, as we have already noted, the court held that such access could not be obtained without a subpena or search warrant that delimited the confines of the search by designating the needed documents. The constitutional problems raised under the Food, Drug, and Cosmetic Act are increased significantly by H.R. 16363 which, unlike the former act, would authorize unlimited access to company records. Refusal by a company to permit such inspection would apparently be dealt with in one of two ways. The Secretary could either refuse to provide plant and product inspection, thus rendering any interstate shipment of poultry from the plant in violation, or he could prosecute the offending company or individuals for a criminal violation under section 12(a). In either case the constitutional limitations announced in Camera and See-and applied in Stanack-would come into play, to require that such penalties could be imposed only if the inspector who CO RA. RA CO |