or exemption is sought. The administrative procedure outlined in the bill is elaborate and would consist of two stages-the first stage terminating in a tolerance or exemption regulation effective upon publication (with a possible intermediate phase of referral to an advisory committee), the second stage involving consideration of and action upon objections filed by any interested persons seeking modification of such regulation-each stage probably subject to the plenary-hearing provisions of the Administrative Procedure Act and each subject to de novo judicial review. The procedure for amending or repealing such tolerance or exemption regulations would be fixed by procedural regulations established after hearing. Temporary tolerances, or exemptions, could be granted for pesticides covered by experimental permits under the Insecticide, Fungicide, and Rodenticide Act. The bill also contains transitional provisions. The subject of chemicals added to food was extensively studied during the 81st and 82d Congresses by the House Select Committee To Investigate the Use of Chemicals in Food and Cosmetics (Delaney committee). Insofar as pesticides are concerned, the present bill is presumably intended to reduce, though not in the way recommended by the Delaney committee, the dangers to consumer health arising from the use of these chemicals (see H. Rept. No. 2356, 82d Cong.). However, in our judgment the bill in its present form is not properly designed to meet the need, found by the Delaney committee, of protecting the health of consumers of food from the use of newly developed pesticides of unknown or uncertain toxic properties, and would in fact make inapplicable to pesticides some of the basic protection from poisonous substances in or on food now specified in the Food, Drug, and Cosmetic Act. This does not mean that we would object to separate legislative treatment of pesticides in dealing with the overall problem of chemicals in food. Interstate commerce in pesticides is now to some extent regulated under the Insecticide, Fungicide, and Rodenticide Act which provides for registration of pesticides by the Secretary of Agriculture and regulates the label and directions on pesticides, primarily for the benefit and protection of the user of pesticides. While this regulatory scheme does not serve the same purposes as the Food, Drug, and Cosmetic Act, implementation of the Delaney committee's recommendations on pesticides-which envision that introduction of pesticides (intended for food production) into interstate commerce be permitted only after approval of an application showing adequate testing for consumer safety, etc.-should, of course, take into account the question of coordinating the two acts. This relationship, and the difference in function between pesticides and other chemicals used in food production, as well as certain technical problems, point to separate legislative treatment of pesticides. The difficulty, however, is with the specific provisions of the present bill. The Delaney committee found no fault with the provisions of the act governing the issuance and judicial review of tolerance regulations. It found, however, that additional protection was needed. There are constantly developed and placed on the market insecticides and other pesticides intended to be applied to food. In some cases very little is known with respect to either the acute or chronic toxicity of such substances and their effect when ingested with food, especially in the light of other poisons consumed in the diet. In many cases practical methods of analysis to permit identification and measurement of residues of such substances on or in food sold to the consumer have not been developed. Tolerances cannot be fixed until this knowledge is available. In the meantime, the consumer remains unprotected unless and until the Government has done sufficient testing and investigative work to determine whether the pesticide is poisonous or deleterious, and, if it is, to determine whether or not it is safe at the level in which it is present in the food (assuming that some residue is unavoidable). The committee concluded that, before a pesticide not generally recognized by experts to be safe can be marketed, the burden should be on the manufacturer or distributor of the pesticide to conduct the necessary tests to assure the safety of the product and to develop and make available adequate methods of analysis for determining the amount of residues of the pesticide remaining in or on food. To this end, the committee recommended the enactment of legislation for this purpose along the lines of the "new drug" provisions of the act or along the lines of the Meat Inspection Act. The present bill, as above indicated, rejects the solution of the Delaney committee insofar as new pesticides are concerned, and, while providing for the issuance of tolerance regulations or exemption from tolerance requirements upon petition of an applicant for registration under the Insecticide, Fungicide, and Rodenticide Act, containing data as to composition, toxicity, residue tests, etc., the bill would do away with essential safeguards contained in the present act. The following comment is a summary statement of the major objections arising from a study of the bill: 1. The bill would require the issuance of a tolerance regulation or exemption from tolerance requirements even if a given poisonous or deleterious pesticide is not needed or can be avoided in the food supply. Under existing law, on the other hand, poisons and deleterious substances are permitted in foods only to the extent that they are clearly required or not avoidable in production of the food, and then only in such small amounts that the public health will not be harmed. The bill would thus seriously weaken existing law and would allow in the Nation's food supply poisonous and deleterious substances which have been kept out of foods under such law. For example, since fungicides are included in the definition of pesticides, we would, under the bill, have to establish tolerances for virulently poisonous preservatives designed to prevent spoilage by various classes of fungi, such as molds, yeast, and bacteria, and this notwithstanding the fact that under modern methods of food preservation-proper sanitation and packaging, heat treatment, refrigeration, and the like these chemical preservatives are not needed. It seems, also, that under the bill we would have to provide tolerances for pesticides not intentionally introduced on food but carried there by animals or otherwise contributed to food during handling or storage. This would be true, for example, of such a deadly rat poison as 1080 which, because of its extreme toxicity, should not be permitted in or on food in any quantity. 2. The Delaney committee considered it essential to consumer protection that a pesticide which is not generally recognized by experts as safe-be itself barred from interstate commerce unless, upon an application patterned after the new-drug provisions of the Food, Drug, and Cosmetic Act, it has been found affirmatively that, if used in accordance with directions (including directions for removal of excessive quantities remaining in or on the food), the pesticide is safe for use in connection with food or food production as described in the application. Under the existing provisions of the Food, Drug, and Cosmetic Act, on the other hand, there is no regulation of commerce in pesticides as such; that act at present reaches only the treated food, after its introduction into interstate commerce. The Federal Insecticide, Fungicide, and Rodenticide Act, while regulating pesticides as such and declaring a pesticide misbranded unless its labeling contains necessary directions for use, and necessary warnings which are adequate if complied with for the protection of the public, does not affirmatively require that adequate tests be made nor place the responsibility upon the applicant for registration to prove the safety and effectiveness of his product. The acc provides that even when the labeling of a pesticide does not appear to the Secretary of Agriculture to comply with the law, the applicant may request registration under protest. The product may then be marketed, at the manufacturer's risk, until any necessary scientific tests-which may, in some cases, require extensive periods of time-have been made and it has been proven in court that the product is in violation of the law. We note from the report of the Department of Agriculture that that Department interprets section 407 (d) (1) in the present bill-which merely provides that a person who is submitting an application for registration of a pesticide under the Insecticide, Fungicide, and Rodenticide Act may file a petition (containing certain data) for a tolerance or exemption regulation under the Food, Drug, and Cosmetic Act-to mean that such registration of a pesticide (for which a food tolerance is required) "is not contemplated until the tolerance has been determined and there is adequate evidence that the treated product will not bear a residue greater than the tolerance." This seems to imply further that, if an applicant for registration of such a pesticide by the Secretary of Agriculture refrained, as he could, from petitioning for a tolerance or exemption under the Food, Drug, and Cosmetic Act, such registration would have to be refused unless a tolerance or exemption were already in effect or unless we should issue one on our own initiative. Interpretation of the Insecticide, Fungicide, and Rodenticide Act at the administrative level is, of course, for the Department of Agriculture rather than this Department. However, since effective consumer protection would depend heavily on such a meshing of the two acts, we believe that this matter should not be left to interpretation of ambiguous language which might easily be upset by the courts; cf. United States v. Cardiff (344 U. S. 174)—but should be clearly spelled out in the bill. If that were done, and done along the lines of the interpretation described, it would to that extent strengthen consumer protection along the lines suggested by the Delaney committee. (However, the showing required to be made under the bill by a pesticide distributor would, as shown below, not measure up to the showing of safety which the Delaney committee found essential to consumer protection.) 3. The bill would do away with the express requirement of existing law (sec. 406) that, in fixing a tolerance for a pesticide, the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances must be taken into account. Such a requirement is essential. No tolerance would be safe or realistic unless it took into account not only the particular poison used on a given class of food, but its relationship to the consumer's total diet and the poisonous substances otherwise absorbed in that diet (see S. Rept. 493, 73d Cong.). 4. Even when a petition is voluntarily filed-there is no requirement for filing— the bill would not require that the petition contain information as to removal of residues or, most importantly, that it describe methods of analysis for quantitative determination of such residues in or on foods (unless the requirement of the bill that the petition contain information as to "tests showing the amount of residue remaining" is intended to have this effect). This information is essential. 5. If a petition complying with the bill is filed, it seems that the Secretary would apparently be required to issue a tolerance or exemption from the tolerance requirement even if not satisfied from all the information at hand that the pesticidal residue will be unavoidable and safe in the quantity permitted by the tolerance-taking into account the consumer's entire diet-and that the methods of analysis for the quantitative determination of such pesticide remaining in or on food, and for the removal of excessive portions of such residue, are accurate and otherwise adequate. It has been suggested that the term "tolerance" would permit us, in appropriate cases, to establish a tolerance of zero. This, however, would be contrary to the common understanding of the term "tolerance," and it is doubtful-even if the legislative history indicated an intention that the term should have that meaning-that the courts would so construe it. 6. As already indicated, both stages of the administrative proceeding would apparently be governed by the elaborate hearing requirements of the Administrative Procedure Act, and an order establishing or modifying a tolerance regulation could be based only on substantial evidence contained in the administrative record and would have to include detailed findings of fact in support of the order. Despite these safeguards, the bill not only would allow court review (in the United States District Court for the District of Columbia) at the end of each stage of the administrative proceeding, but it provides that such court review shall be de novo, with additional testimony admissible in court-this seems to be in addition to a provision permitting additional evidence to be taken at the administrative level-and specifies that no presumption of validity shall attach to the administrative order under review, that the court shall make its own findings of fact on the evidence, and that the court may either affirm, modify, or set aside the administrative order or direct this Department to modify or amend its order in conformity with the court's findings (p. 9, lines 1-8, 18, 19). This would, apparently, authorize and require the court to substitute its own judgment and discretion for that of the Secretary of Health, Education, and Welfare in the exercise of the quasi-legislative function which rulemaking, as distinguished from adjudication, represents. Under existing law, on the other hand, judicial review-which is had before a United States court of appeals in the circuit where petitioner resides or has his principal place of businessis limited strictly to the legal validity of the administrative regulation upon the basis of the administrative hearing record and findings, the court is bound by the administrative findings of fact if supported by substantial evidence in the record taken as a whole, and the court cannot modify the administrative order or otherwise substitute its own judgment for the administrative judgment as to the soundness or desirability of a valid order. If the administrative order-which is quasi-legislative in nature and involves the exercise of a scientific judgment on the health hazard presented by the presence of pesticidal residues in or on the food and as to what is necessary to protect the public health, giving appropriate consideration to the necessity for the production of an adequate and wholesome food supply-is to have no presumptive force or effect upon judicial review, thus rendering the administrative order promulgated after costly and time-consuming proceedings virtually meaningless, it seems proper to ask whether it would not be better to cast the entire job on the judiciary. Apart from this, however, it seems plain that this departure from the pattern of the present act and from the general pattern of judicial review of administrative orders under other programs, especially orders which, as these, are quasi-legislative in character, would cast an impossible burden upon the court. (In this connection, we invite attention to the testimony of Chief Judge Stephens, appearing on behalf of the Judicial Conference of the United States before the House Committee on Interstate and Foreign Commerce at hearings on H. R. 3298, 82d Congress, which (as introduced) contained a provision for de novo judicial review somewhat similar to, though perhaps less sweeping than, the present bill. That provision was deleted before H. R. 3298 became law (Public Law 215, 82d' Cong.)). The judicial-review provisions of the present bill also raise serious constitutional questions. The much more limited provision of the present act was thought by the Congress which enacted it to be "as broad as the Constitution permits in the case of review by a constitutional court." (Conference report, H. Rept. No. 2716, 75th Cong.) Certainly, if, as we think, the bill would confer quasi-legislative functions on the reviewing courts, it would clearly preclude the ultimate resort to the United States Supreme Court envisioned by the bill, because that Court is strictly limited by the Constitution to the exercise of judicial power and may not, in the exercise of its appellate jurisdiction act as a revisory agency in the review of what are essentially legislative or administrative decisions. Moreover, while the bill, at the lower levels of judicial review, would give jurisdiction only to the District Court and Court of Appeals for the District of Columbia, these courts, too, are constitutional courts that is created under the judiciary article of the Constitution), and though Congress may invest them with nonjudicial functions in virtue of its plenary power over the District, one may question whether it may delegate to local courts for the District what are essentially legislative powers in matters not limited to the affairs of the District. (This precise question, so far as we know, has never been decided, though Congress did in fact vest such powers in the courts of the District at a time when such courts were thought to be legislative courts.) In this connection, it should also be noted that the author of the bill has suggested in a letter to this Department that the bill should be amended so as not to limit judicial review (below the Supreme Court) to the District of Columbia courts. 7. The bill would require us to refer a petition for a tolerance or exemption to an advisory committee of experts for its recommendations, if so requested by the petitioner or considered necessary by us. We have no objection to the establishment of ad hoc advisory committees of experts to consider and make recommendations on technical scientific questions. The provisions of the bill, however, which require that the committee consist in equal numbers of representatives designated by the petitioner, by this Department, and by the chairman of the Food Protection Committee of the National Research Council would make the committee resemble more nearly an arbitration committee appointed to represent points of view than a committee of disinterested experts. Moreover, the requirement of the bill that the members of the committee be "particularly qualified in the specific subject matter of the petition" could easily make it impossible to form an advisory committee or could limit its membership to the scientists whose experiments are under review. Finally, the provision specifying that petitioner shall be entitled to consult with the committee seems one-sided unless an equal right of consultation with the committee on the part of the Secretary is assumed. 8. The requirement of the bill that a tolerance or exemption regulation be issued within 90 days after the filing of a petition, or within 30 days after receipt of the report and recommendations of the advisory committee if the matter is referred to such a committee, and that the advisory committee must report upon any case referred to it within 60 days, may obviously make it impossible either for such a committee or for this Department to give adequate consideration to the matter and would force the issuance of ill-considered regulations. 9. While, as above indicated, the bill would, on the one hand, not allow adequate time for proper consideration of the matter at the first stage of the administrative process, the requirement (inferred from the Administrative Procedure Act, coupled with the provisions of the bill) that there be a plenary hearing at each stage, with the petitioner, given standing at both stages, seems cumbersome and wasteful, even without considering the provisions for still another de novo consideration in the courts. At the same time the opportunity of interested persons other than petitioner to evaluate and contest the administrative action might be rendered largely illusory by the requirement of the bill that all data submitted in support of the petition be held confidential. 10. The bill makes no provision for the charging of fees. We believe that any legislation dealing with this subject should include provisions authorizing this Department to charge applicants who wish to distribute pesticides reasonable fees sufficient on an overall basis to enable us to provide, equip, and maintain an adequate and efficient organization for passing upon the adequacy of the submitted evidence and otherwise carry out our functions relating thereto. In view of these considerations, we do not believe that the bill in its present form would be a suitable vehicle for carrying out its sound objective, stated in its title, "to provide for the health and protection of the citizens of the United States from harmful chemical additives in pesticides." We believe, however, that suitable legislation to close the existing gap in consumer protection, as respects pesticides used in food production, is needed, and that the above-mentioned objections (as well as certain technical difficulties) to the present bill can be overcome, either by appropriate revision of the bill or by substitution of a "clean bill," as the committee may desire. We should, of course, be glad to cooperate toward that end. We are advised by the Bureau of the Budget that, while that Bureau perceives no objection to the submission of whatever report we may deem appropriate, it is unable to advise as to the relationship of this bill to the program of the President. Sincerely yours, OVETA CULP HOBBY, Secretary. Hon. CHARLES A. WOLVERTON, DEPARTMENT OF JUSTICE, Washington 25, D. C., June 18, 1953. Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D. C. DEAR MR. CHAIRMAN: This is in response to your request for the views of the Department of Justice concerning the bill (H. R. 4277) to provide for the health and protection of the citizens of the United States from harmful chemical additives in pesticides. The bill which would be cited as the pesticides-residue amendment to the Federal Food, Drug, and Cosmetic Act, would provide that a food shall be deemed to be adulterated if it contains any poisonous or deleterious pesticide which is unsafe. Any poisonous or deleterious pesticide added to a food shall be deemed to be unsafe unless the quantity thereof does not exceed the limits of a tolerance fixed by the Administrator of the Federal Security Agency, or the pesticide has been exempted by the Administrator from the requirements of a tolerance. The bill would provide a procedure for determining whether a pesticide is useful for the purpose for which a tolerance or exemption is sought and for the promulgation of regulations by the Administrator establishing a tolerance for the pesticide or exempting it. Regulations of the Administrator are made subject to judicial review. Whether the measure should be enacted involves a question of policy concerning which this Department prefers to make no recommendation. The Bureau of the Budget has advised that there is no objection to the submission of this report. Sincerely, Hon. CHARLES A. WOLVERTON, WILLIAM P. ROGERS, Deputy Attorney General. THE SECRETARY OF COMMERCE, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D. C. DEAR MR. CHAIRMAN: This letter is in reply to your request of March 30, 1953, for the views of this Department with respect to H. R. 4277, a bill to provide for the health and protection of the citizens of the United States from harmful chemical additives in pesticides. This bill would amend the Federal Food, Drug and Cosmetic Act by adding thereto a new set of provisions dealing specifically with pesticides used in the production, storage, or transportation of food. The bill appears to have no adverse effect upon the production or supply of chemicals and its objectives seem desirable from the viewpoint of the public health. |