STATEMENT OF REUBEN L. JOHNSON, DIRECTOR OF LEGISLATIVE SERVICES, NATIONAL FARMERS UNION Mr. Chairman and Members of the Subcommittee: The delegates to the convention of National Farmers Union, February 28-March 2, in Houston, Texas, passed policy statements concerning the environment which are attached hereto as Exhibit A. Farmers Union is an organization of operating farm families. In view of this fact, our organization is heavily oriented toward the interest of full-time farm operator families. The environment is just one of the broad range of issues on which our convention delegates make policy each year. On the matter of pesticides and the environment our members and delegates believe that family farming is a far superior means of protecting the environment. More prudent and safe use of pesticides is possible on family farms than is possible under a system of corporate agricultural productive processes. Therefore, our membership takes strong exception to those national policies which continue to force migration from rural areas into cities. In short, we believe that the family farm system of agriculture affords the best protection from pollutants in the air, soil and water. Our policy statement proclaims that ecological balance "can best be achieved through maintenance of a family-type agriculture in which crops are rotated, livestock waste is not in excess of the volume that can be returned to soil through organic decay, a farm forestry plot is protected, and other conservation measures are common practice. Corporate agriculture, on the other hand, is less sensitive to natural resource conservation. There is particular need for control of corporate-dominated industrial livestock feeding-which has resulted in serious water and soil pollution." Many of the decisions which the Administrator of the Environmental Protection Agency must make under the provisions of pesticide control legislation will be difficult decisions. There undoubtedly will be considerable area of disagreement at times. The reconciliation of differences, therefore, is extremely important. In this regard, we believe that the recommendations made to the Senate Agriculture and Forestry Subcommittee on Agricultural Research and General Legislation by the Environmental Protection Agency witness, David D. Dominick, to be constructive. We view other changes in H.R. 10729, recommended by Mr. Dominick, also to be constructive and helpful. In this connection there is one amendment Mr. Dominick mentioned which Farmers Union strongly supports. That is the provision in Section III that test data submitted in support of a pesticide registration application cannot be considered by the EPA Administrator without permission of the originator of the data if such data tends to support another registration application. The objectionable language that we recommend be deleted from the bill as reported by the Senate Agriculture and Forestry Committee is found on Page 19, beginning on Line 10 after the comma, and extending through the colon on Line 14. The language that we recommend be deleted from the bill is as follows: .. except that data submitted in support of an application shall not. without permission of the applicant, be considered by the Administrator in support of any other application for registration:" 66 To further explain our objection to this provision of the bill. I would like to quote briefly from a letter received from Mr. Art Wolcott, Manager, Chemical Department, Agri Products Division, Farmers Union Central Exchange, 1185 North Concord Street, South St. Paul, Minnesota, as follows: "The Protection offered chemical producers in this bill would virtually prohibit any other producer from competing. The investment in money and time to develop the data for registration would not be available in the face of the 17 years protected profits of the original registrant. "To cite an example using the pesticide product, Atrazine. It was patented in 1956 and is protected by a 17-year United States Patent until 1973. No one else can produce it during the life of the patent. If HR 10729, section 3(c) (1) (D) were law, it would protect (Geigy) Atrazine from competitive production, registration and marketing for another several years. It would be protected for the period required to produce efficacy data, tissue study data and a complete file of data suitable for registration, which may take five years. This would duplicate the data already on file with EPA registration section and serve no useful purpose. Of the chemical products now being marketed, 90% are protected throughout the 17 years of the patent duration. "Hence, this section of the Act is designed to provide chemical producers with additional exclusive production, pricing and marketing. Such a restriction would deprive farmers of benefits of competitive chemical production and marketing." Also, Mr. Chairman, to supplement the quote from Mr. Wolcott, I would like to quote from the testimony of the EPA witness, Mr. Dominick, who said: "The effect of this provision is to afford additional economic protection, foster monopoly, and it may tend to restrict pesticide business to large manufacturers. In addition, it would increase not only Federal administrative cost, but those of the manufacturer as well, aside from unnecessarily increasing the application processing time." The cost of such protection as this provision affords large manufacturers of agricultural chemical pesticides will be borne solely by the user-the farmer. Many of the products developed by large manufacturers of pesticides would not have been possible without access to federal research. It is our conclusion that not to strike the objectionable language referred to above would constitute a gross injustice to farmers, to farmer cooperatives and to small business distributors of pesticides, as well as adding unnecessary "red tape" procedures to the administration of the program. I respectfully request that the attached Supplementary Statement be made a part of the record of hearings. SUPPLEMENTARY STATEMENT OF NATIONAL FARMERS UNION, JUNE 5, 1972 In our correspondence to you dated November 11, 1971 we pointed out a phrase that is objectionable in HR 10729, the Federal Environmental Pesticides Control Act. It is objectionable for these important reasons: HR 10729 is an Act conceived and designed to more closely regulate the use of pesticides. The "exclusive use of data" phrase is totally unrelated to this concept and should be removed. The objectionable part would provide indefinite extension of the 17 years of that protection, to the exclusive benefit of the producers of patented chemical compounds and at the expense of the farmers who use chemical compounds. In addition to the information in our November 11, 1971 statement we here list excerpts from and cite the testimony of the following which was presented in the hearings before the Subcommittee on Agricultural Research and General Legislation of the Committee on Agriculture and Forestry of the U.S. Senate on HR 10729, Part II, March 7 and 8, 1972. Pages 364 through 369, testimony from Senator Hart, Chairman, Committee on Judiciary Subcommittee on Antitrust and Monopoly Legislation. Senator Hart also encloses the opinions of two noted scholars regarding the effect and advisability of the so-called "exclusive use data" section of the bill. I quote from Senator Hart's testimony, page 363, third amendment, and page 365: "Efficiency and barriers to entry.-The House bill requires that in evaluat ing the acceptability of a pesticide for registration the Administrator may not consider the data of any similar pesticide, or for that matter, the data of any other manufacturer of the same pesticide. Our amendment would eliminate this requirement on the grounds that the duplication of test data which would result from it is wasteful and that the provision may pose a barrier to entry of competitors into the market above and beyond those provided by our patent laws." "Obviously, the Administrator is needlessly hamstrung in his duties having information on file which could reflect either positively or negatively on pending applications for pesticide registration but not being able to use it. "This restriction is unnecessary because Title 35-the Patent Code-provides complete protection against infringement of the particular patent in question provided, of course, a patent has been sought. If a patent has not been sought or granted, then the applicant should not be entitled to the protection afforded by our Patent System; and efforts to expand patent protection outside the confines of Title 35 should not be enacted without full and expert deliberation. "Similarly, should the information proferred pursuant to section 3 (c) (1) (D) be proprietary information in the nature of a trade secret, full protection is afforded by the elaborate trade secret provisions of section 10." I quote from the testimony of John C. Stedman, Professor of Law, University of Wisconsin: "There is almost always in the regulatory process, an on-going conflict between the salutary public purpose (in this case, protection of the environment against damaging pesticides) and the danger that the regulatory process will be misused by protecting those already in the field through denial to qualified competitors of the right to enter. The present proposal constitutes a real threat in the latter sense while serving no useful purpose in the former. The only conceivable legitimate purpose to be served by the proposal, as I see it, is the protection of equities in one who has pioneered in the development of a drug-and gone to considerable research effort and expense, especially with respect to its impact on the environment-by preventing others from getting a 'free ride' on his experience with no cost to themselves. But the 'free ride' is endemic in our society and something to be legislated against only occasionally (as in the patent system, the recent 'tape piracy' legislation, etc.) and after careful attention to the countervailing adverse effects of such legislation. "This does not seem to be such a case, and certainly not one to be resolved in the broad, loose terms of the clause here in question. (1) There is no necessary correlation between the advantages gained by the applicant whose data is withheld and the burdens he has borne in collecting the data. (2) The provision gives no attention to, and makes no allowance for, the offsetting advantages the applicant has enjoyed as a result of his 'headstart' or his continuing benefits from the genuine trade secrets he may have developed (it should be emphasized that this provision is not needed to protect legitimate trade secrets-these are adequately protected by Section 10, and in any event the clause in question goes far beyond trade secret protection and prohibits the Administrator from even using the knowledge he possesses not just from publicly disclosing it). (3) The collection of his data may well have entered into, and been part of the consideration for, the grant of his pesticide patent (if he has one) in view of the 'utility' requirement contained in our patent law. (4) It is quite possible that some or all of his expense may already have been paid through Government funding (see, e.g., Section 20 of the bill). (5) Assuming, arguendo, that the data collector is entitled to some form of remuneration for his efforts, the proposal here picks one of the worst possible forms for achieving this, namely, protection against legitimate competition. (6) While the provision contains sufficient loopholes that a strongly public-interest-oriented Administrator could probably avoid the more serious impacts, it could easily become an instrument of obstruction in the hands of a timid Administrator or one more fully attuned to the interests of selected suppliers than to the interests of the public. "For the reasons given, I agree with Congressman Kastenmeier's recommendation that the underlined clause be deleted." I quote from the testimony of John J. Flynn, Professor of Law, University of Utah: I could find nothing in the report supporting any claimed injury or abuse of the existing statute that would justify the language added by Section 3(c) (1) (D). Moreover, the following analysis would seem to be logical and appropriate: the registration requirements of the Act establish a government created barrier to entry in the pesticide business; a major feature of that barrier to entry is the requirement of testing new pesticides, a cost which is to be borne by applicants; this cost can be assumed by some applicants better than others, but it is not a cost relating to economic efficiency; it is a cost that is government imposed and, as such, it is a cost which should not be imposed any further than is necessary. Vesting control over this cost in an applicant, so that he can use a government cost barrier to entry to hamper subsequent competitors is totally wrong. The information required is and should become public information, it should be freely used by the agency in the performance of its duties under the Act, and the provision as it now stands only serves the purpose of allowing applicants to hamper competition and efficient administration of the Act... I quote from the testimony of David D. Dominick, Assistant Administrator, Environmental Protection Agency, page 95, Section 2: "The effect of this provision is to afford additional economic protection, foster monopoly, and it may tend to restrict pesticide business to large manufacturers. In addition, it would increase not only Federal administrative costs, but those of the manufacturer as well, aside from unnecessarily increasing the application processing time. . . The complete testimony of the above participants is in agreement with request that the phrase on "exclusive use of data" be stricken from the Act. However, in view of possibility that some unforseen situation may arise, it is agreeable to us that the following be inserted in place of the "exclusive use of data": "Except that a hearing may be requested by the original registrants to determine the advisability of withholding the data submitted by the original registrant from use in substantiating the label claims of a subsequent applicant." SPORT FISHING INSTITUTE, Washington, D.C., April 5, 1972. Hon. PHILIP A. HART, DEAR SENATOR HART: The Sport Fishing Institute, a national non-profit, professionally-staffed fish conservation organization supported largely by interested anglers and the sport fishing industry of the United States, strongly supports your proposed amendments Numbers 1003 through 1013 to H.R. 10729. It is our belief that these amendments will provide a basis for more effective pesticides regulation by strengthening H.R. 10729, the Federal Environmental Pesticides Control Act of 1971. It will be much appreciated if this communication of views may be included in any record of related public hearings. Thank you. Sincerely, RICHARD A. WADE, Executive Secretary. MS. JEANNE C. DANGERFIELD, 1000 Wisconsin Avenue, Washington, D.C. ENVIRONMENTAL PROTECTION AGENCY, DEAR MS. DANGERFIELD: We have your letter of May 3 requesting copies of annual reports from our Community Studies projects. We regret that we are unable to send copies of these to you. We have no extra copies available and they are too bulky to copy. In addition, they are interim, unpublished and often incomplete reports, and as such would not be too suitable for your purposes. Much of the work of the Community Studies has been published in a wide variety of technical journals. A list of these publications is attached. We will be happy to send you single copies of any of these. An article describing our program is attached for your general information. We are also enclosing a listing of all of our publications. Single copies of most of these are available upon request. We hope this information will be of use to you. Please do not hesitate to contact us for copies of individual articles. Sincerely yours, CLAUDIA B. LEWIS, Technical Information Specialist, Enclosures [Reprinted from FDA Papers, May 1969] LIVING LABS THAT STUDY HOW PESTICIDES AFFECT MAN (By Samuel W. Simmons, Ph. D.) In New Jersey, a worker in a pesticide chemicals factory reports after his shift to the plant clinic near Trenton for a thorough medical examination. In Texas, the pilot of a plane used for dusting agricultural crops with pesticides visits his doctor, and afterward, the physician reports his observations on the state of the pilot's health to the State Department of Health office in San Benito. In Mississippi, a farm laborer who lives near a cotton field regularly sprayed with pesticides reports to the University of Mississippi Medical Center at Jackson for intensive medical checkups. In Utah, a worker who applies pesticides in mosquito control work drops by the State Department of Health office in Salt Lake City for a medical going over. These people have two things in common. They are regularly exposed by occupation or environment to pesticides with unusual frequency or in unusual amounts; for this reason, they have agreed to act as volunteer experimental subjects in a nationwide program aimed at bringing to light the effects this exposure may have on the various systems and organic processes of their bodies. The Community Studies Pesticides Projects, collectively one of the most ambitious health observation programs ever undertaken on a countrywide scale, has been in operation since 1965. Since last July, the projects have operated under the Division of Community Studies of the FDA Bureau of Medicine's Office of Product Safety. The projects are carried out under Federal contract by State Health Departments or universities in 15 widely scattered areas or communities in the contiguous States and Hawaii. Their objective: to collect and evaluate information aimed at finding whether and how exposure to pesticides, as experienced in an occupation or in the environment, is affecting the health of Americans. For the basic study in each community, the contractor keeps close tabs on the medical history of an average of 100 volunteers who, because of their occupations or their environment, are subject to greater exposure to pesticides than the population at large. They include workers in pesticide formulating plants; employees of plant nurseries; agricultural workers on farms, ranches, or orchards where pesticides are used heavily or often; pilots of aircraft that dust crops or ranges; pest control workers; or those who live in localities where pesticides may be expected to permeate the living area to a greater extent than would be found normally. In addition, a limited number of people from the general population known to have had only minimal exposure to pesticides are selected to serve as controls for comparison purposes. These volunteers are given a complete annual physical and neurological examination by their physicians, and in some cases, the contractor carries out the medical examinations. Followup examinations are made periodically, and the results, including samples of urine, blood, and sputum, are analyzed in the contractor's laboratory for determination of any changes or effects. Fatty tissues or tissues from various organs are collected when available, as when a subject undergoes surgery, and are supplied to the laboratory. The information emanating from the studies is evaluated medically and statistically and published in scientific journals. More comprehensive data is funneled on standardized forms to the Community Studies Division in Atlanta, where it will be processed for input into a computer system being developed to see if medical, scientific, or statistical conclusions can be drawn that will have general significance or application. The Community Studies are supported with research in analytical chemistry, primate toxicology, quality control, and other services by the Perrine Primate Research Branch of the FDA Bureau of Science's Division of Pesticides (see color photo story) to assure consistent and uniform quality and high standards of laboratory work that will permit the findings in one community study to be evaluated on the same basis as those of another. An important extension to the Federal Government's activities on the effects of pesticides on man and animals was the establishment by the Public Health Service of a toxicology laboratory at Savannah, Ga. In November 1964, the PHS Bureau of State Services established an Office of Pesticides to deal with a number of recommendations relating to public health that were made by the Life Sciences Panel of the President's Science Advisory Committee after its comprehensive study of the benefits and hazards of pesticides. The Office of Pesticides, which had been formed in Washington, D.C., was transferred in August 1966 to PHS's National Communicable Disease Center in Atlanta and consolidated with that Center's toxicological activities. The new organization was named the Pesticides Program, and in a PHS reorganization last July 1. the program was assigned as the Community Studies Pesticides Projects to the Division of Community Studies of the FDA Bureau of Medicine's Office of Product Safety. |