suits against any person who is alleged to be in violation of any requirement under this Act if certain procedural conditions are met. The most fundamental requirement under the bill is that a pesticide must not be misbranded (Sec. 12(a) (1) (E)). Under the bill, a pesticide is misbranded if— ... the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for which the product is intended and if complied with, together with any requirements imposed under Section 3(d) of this Act, are adequate to protect health and the environment. [Sec. 2 (q) (1) (F)] This definition in turn invokes the benefit-risk test which is a determination the Administrator must make as a part of the registration process. Thus, any district court faced with a citizens' suit must either accept the Administrator's determination or ignore it. If the district court were to ignore the Administrator's determination, it must substitute its own judgment. The consequences would be as many EPA Administrators as there are district court judges plus the actual head of the agency. If the court accepts the Administrator's determination, the issue is resolved before it is begun. An analysis of the other requirements of the bill establishes that they are either of a nature easily enforceable by the agency (e.g. record keeping, labeling) or involve the discretionary factors illustrated above. In explaining the proposed provision for citizens' suits, the sponsors stated: "In this time of increasing interest by the public in social policies that directly affect every member of the public, I believe it is necessary and important to allow citizens to participate in the enforcement of laws that have an impact on their lives." [Senate Agriculture Committee-Summary of Amendments] The National Agricultural Chemicals Association recognizes the sincerity of the proposal and its good intentions but submits that the "increasing interest in policy" is a basis for a practical method of participation in policy making procedures, not for participation in enforcement. To this end, the Association has advocated practical methods of bringing the public into the policy making procedures in this complex field of regulation. Although the recommendations of the Association concerning such participation were not adopted by the Agriculture Committee of the House and Senate, the National Agricultural Chemicals Association believes that the procedure adopted by those Committees does provide for a workable system of public participation in policy making decisions. The amendments proposed by Senators Hart and Nelson raised a number of other significant issues. Several of these issues were resolved by the Senate Committee on Agriculture and Forestry in a manner which we consider to be satisfactory and which we hope are satisfactory to the sponsors. We realize that there were a number of other proposals in the amendments which were not adopted. We will not attempt to specifically discuss each of these issues but will be glad to attempt to answer any questions concerning them which the Committee may have. We appreciate the opportunity to appear before the Committee and present the views of our Association. APPENDIX A* CRITERIA FOR PESTICIDES REGISTRATION AND ESTABLISHMENT OF TOLERANCES DEPARTMENT OF AGRICULTURE Registration requirements 1. Criteria for establishing registration: The applicant for registration must furnish documented proof to support the claims made for the proposed product. Data required to support registration usually include the following: A. Toxicity tests.-Toxicity tests on the proposed formulation must be conducted to show that the directed use of the product would not be injurious to Source: "The Regulation of Pesticides in the United States"; U.S. Department of Agriculture; U.S. Department of Health, Education, and Welfare Food and Drug Administration; March 1968. exposed man or beneficial animals when warnings and cautions are carefully followed. The extent of toxicological data required will vary with the nature and proposed use of the product. Toxicity studies normally include: (1) Safety data: a. Acute mammalian studies 1. Oral. 2. Dermal. 3. Inhalation. 4. Eye and skin irritation. b. Subacute studies 1. Oral-90 days. 2. Dermal-21 days. 3. Inhalation-14 days. c. Other studies which may be required include 1. Neurotoxicity. 2. Teratogenicity. 3. Effects on reproduction. 4. Synergism. 5. Potentiation. 6. Metabolism. 7. Avian and fish toxicity. (2) Physical-chemical properties: a. Boiling point. b. Flash point. c. Physical state. d. Density. e. Vapor pressure. f. Solubility. g. Stability. B. Efficacy data.-Biological tests under field and laboratory conditions must be conducted to determine if the product will control the pests named on the label, when used as directed, without causing significant adverse effects to the crop or property being treated. The following factors are considered in determining efficacy: (1) Effectiveness. The product must be shown to be effective for the intended purposes when used as directed. (2) Phytotoxicity. (3) Translocation within the plant or animal being treated. (4) Persistence in soil, water, or plants. (5) Compatability with other chemicals. (6) A thorough search and evaluation of the data submitted as well as other applicable data are made. After such search, the Department of Agriculture specialists concerned with efficacy determine whether or not the proposed formulation would be useful for the intended use without causing significant adverse effects when applied according to the proposed labeling. 2. General labeling requirements: A. Name of product. B. Name and address of manufacturer, registrant, or person for whom manufactured. C. Net contents. D. Ingredient statement.-Name and percentage (by weight) of each active ingredient, and total percent of inert ingredients, or name of each active and each inert ingredient in descending order, and relative abundance in each category and the total percentage of inert ingredients. E. Warning or caution statement. The label of any economic poison must show warnings pertaining to: (1) Ingestion. (2) Skin absorption. (3) Inhalation. (4) Flammability or explosion. The required signal word such as "DANGER." "WARNING." or "CAUTION." and the statement "Keep Out of Reach of Children" must appear on the front panel and meet the minimum type size requirements. The front panel of the label of economic poisons which are highly toxic to man must show: (1) "Poison" in red on a contrasting background. (3) Skull and crossbones. (4) Statement of antidote, including directions to call a physician immediately (in immediate vicinity of skull and crossbones and "Poison"). F. The registration number assigned to the product. G. Directions for use which are adequate to protect the public (optional on label-may appear on accompanying printed or graphic matter). 3. Other required information: A. Data to support any or all claims on the labeling. B. A complete statement of the composition of the product, including the percentage by weight of each of the active and inert ingredients, if such information does not appear on the label. C. Any pertinent information about inert ingredients. D. Any other information pertaining to physical or biological properties of the product, etc. 4. Review by other agencies: Petitions for registration filed with the Department of Agriculture are reviewed and commented on by other Departments of the Federal Government. The Department of the Interior reviews all petitions for registration whose use patterns may have an impact on fish or wildlife. The Public Health Service of the Department of Health, Education, and Welfare reviews all petitions from the standpoint of human safety. The comments of these two agencies are forwarded to the Department of Agriculture and are considered before registration is granted or refused. Opinion on adequacy of residue data and proposed tolerance An analytical method suitable for enforcement purposes must be provided with the petition, when suggested use patterns will result in residues of the chemical on food or feed. The analytical method and the residue levels presented in the petition are evaluated and an opinion on whether the proposed tolerance reasonably reflects the residue is forwarded to the Food and Drug Administration. The review includes consideration of the residues of the parent chemical metabolites, and the conversion products that may be formed. Residues occurring in plant parts other than the principal raw agricultural commodity are also considered. Manpower and funds on criteria and registration There are 258 people engaged in the work of the Pesticides Regulation Division, 115 in registration and 143 in enforcement. The Division is funded at $3,500,000. FOOD AND DRUG ADMINISTRATION If the product is proposed for use in a manner which is likely to result in residues in or on food or feed, it is not registered by the Department of Agriculture until a tolerance or exemption has been granted by the Food and Drug Administration. The determination of the safety of a tolerance is a scientific judgment and cannot be derived from any arbitrary mathematical calculation. This judgment involves consideration of the "no-effect" levels demonstrated in the experimental animals, the cumulative potential, the metabolic data, the maximum contribution to the diet that could be expected if all commodities for which tolerances are sought bore residues at the tolerance levels taking into account any reduction in residues accomplished in preparing the food ready to eat, the probable exposure to other similar toxicants, and species differences in translating the animal data to possible effects on man. An adequate margin between the tolerance level and the "no-effect" level in the experimental data is required, taking into consideration the proportion of the diet involving crops on which residues might be expected. Tolerances established under Section 408 of the Food, Drug, and Cosmetic Act are established on raw agricultural commodities, not on processed foods. If the residues remaining in a processed food have been removed to the extent possible in good manufacturing practices and do not exceed the tolerance on the raw product, the processed product complies with the law. In general, APPENDIX B Definition of trade secret. A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it. It may be a formula for a chemical compound, a process of manufacturing, treating or preserving materials, a pattern for a machine or other device, or a list of customers. It differs from other secret information in a business (see § 759) in that it is not simply information as to a single or ephemeral events in the conduct of the business, as, for example, the amount or other terms of a secret bid for a contract or the salary of certain employees, or the security investments made or contemplated, or the date fixed for the announcement of a new policy or for bringing out a new model or the like. A trade secret is a process or device for continuous use in the operation of the business. Generally, it relates to the production of goods, as, for example, a machine or formula for the production of an article. It may, however, relate to the sale of goods or to other concessions in a price list or catalogue, or a list of specialized customers, or a method of bookkeeping or other office management. [Restatement of Torts, 1939 § 757, Vol. 4, p. 5] APPENDIX C (4) "Trade Secret" means any formula, pattern, device or compilation of scientific, technical, or commercial information which the trade secret owner has taken reasonable precautions to maintain in secrecy so that except by the use of improper means there would be difficulty in acquiring it, and which gives said owner an opportunity to obtain an advantage over others who do not know or use it. In determining whether given matter constitutes a trade secret, the court may consider (a) the extent to which it is independently known to outsiders or is used by outsiders for similar purposes; (b) the extent to which it is known by insiders; (c) the extent of the measures taken by said owner to guard its secrecy; (d) its value to the owner and others, including the extent to which, if used in conduct of a business, it would confer a competitive advantage on said owner; (e) the amount of effort or money expended by said owner in developing it; and (f) the ease or difficulty with which it could properly be acquired or duplicated by others. Matter which otherwise constitutes a trade secret will not loose its status as such if it is disclosed by the trade secret owner to and accepted by an outsider in confidence and with an agreement express or implied to compensate such owner if such trade secret is used or divulged to others. The matter constituting the trade secret must be reduced to tangible or recorded form. It need not be specifically labeled or marked to identify it as "confidential" or "proprietary"; but if not appropriately identified as a trade secret, the trade secret owner must prove by clear and convincing evidence that, prior to the alleged misappropriation, the misappropriator knew or should have known that the subject matter involved was considered by the owner to constitute a trade secret. [Proposed Uniform Trade Secrets Protection Act, Revised Draft 021671, prepared by the American Bar Association Committee 402, Subcommittee C] SELLERS, CONNER & CUNEO, Re H.R. 10729. Hon. DANIEL K. INOUYE, Member, Committee on Commerce, U.S. Senate, Washington, D.C. DEAR SENATOR INOUYE: During the course of the testimony on H.R. 10729 presented upon behalf of the National Agricultural Chemicals Association, you requested that we respond to certain questions which would be given to us by the staff of the Committee. The questions which we subsequently received and our answers are as follows: Question 1. What is your opinion of that portion of the Hart-Nelson Amendment which would remove the provision in H.R. 10729 insuring that "essentiality" would not be a criterion for denying registration? Answer: It is felt that "essentiality" should not be a criterion for registration of pesticides for the following reasons: (1) It is unlikely that two pesticides will have identical properties as they relate to control of a given pest under all conditions. Alternate pesticides should be available so as to allow the use of the one best suited under a specific set of conditions. (2) The possibility of pests developing a tolerance of resistance to pesticides is always present. Where such tolerance or resistance develops alternate means of control including alternate pesticides should be immediately available. (3) There is no reason to believe that the availability of one pesticide for each pest results in greater safety or less risk to the environment than the availability of more than one pesticide for each use. Question 2. Do you object to full participation by citizens in suspension of a registration in view of the fact that such hearings take place before suspensions and if there is an emergency, a district court may stay that effect of such suspension pending a hearing? Answer: This question refers to the expedited hearing provided by section 6(c) (2). This would be a hearing held prior to issuance by the Administrator of a suspension order as contrasted to a hearing which would be held pursuant to Section 6(c)(3) following the issuance of an emergency suspension order. Although the National Agricultural Chemicals Association did not propose the procedure for an expedited hearing prior to the issuance of a suspension order, we did concur in it. This concurrence was based upon the opinion that the procedure reflects a reasonable balance between the necessity for prompt action in making a suspension decision and the right of a registrant to notification and the opportunity to present evidence and views responsive to the issue of suspension prior to the issuance. We considered that the right of a third party to present briefs reflected a reasonable balance of the right of third parties to provide an input in a suspension proceeding, particularly when coupled with recognition of the fact that third parties have ample opportunity to present data and express views to the Administrator outside of a hearing. Unquestionably, the right of third parties to participate in such a hearing including the right to present evidence and cross-examine witnesses would protract the hearing. Although I consider the present provision of the bill as reported by the Senate Committe on Agriculture and Forestry to be reasonable, I, personally, would consider that the only objection to a right of more extensive participation by third parties in such a hearing would be the proliferation of time required for such a hearing. If such a right were granted, the presiding officer would need authority to limit cross-examination and the presentation of evidence to reasonable length. Question 3. What is your opinion on the Hart-Nelson amendment that would give the Administrator the right to grant to any party the opportunity to subpena documents during public hearings? Answer: We assume this question refers to Amendment No. 5 proposed by Senators Hart and Nelson. We support the provisions of Section 6(d) of H.R. 10729 as reported by the Senate Committee on Agriculture and Forestry. This section authorizes the hearing examiner to issue a subpoena to compel testimony or production of documents upon a showing of relevance and reasonable scope of evidence sought by any party to a public hearing. We construe this language as adopted by the Senate Committee on Agriculture and Forestry to be substantially in accord with the proposed Amendment No. 5. During the course of our testimony you asked whether we could give an estimate of the percentage of pesticides now being manufactured in the United States that are not subject to the registration requirements of existing law because they are manufactured solely for export purposes. So far as we are aware there is no data upon which such an estimate could be premised. In the year 1971 domestic sales of pesticides were 477 million pounds as against sales for export of 404 million pounds according to "Pesticide Review" published by the United States Department of Agriculture, Agriculture Stabilization and Conservation Service, 1971 edition. A significant quantity of the export sales constituted purchases by the United States Government for shipment abroad (including purchases by the United States Army which were treated as domestic sales). There is no way of estimating, however, the quantity of these export sales which were federally registered pesticides and those which were not. Very truly yours, JOHN D. CONNER, |