SALT LAKE CITY, UTAH, February 9, 1972. Hon. PHILIP A. HART, Chairman, Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, U.S. Senate, Washington, D.C. DEAR SENATOR HART: The proposed bill amending the Federal Insecticide, Fungicide, and Rodenticide Act, H.R. 10729, does raise issues of the type suggested by Congressman Kastenmeier. The bill requires registration of pesticides before they may be distributed in commerce. The Administrator of the Environmental Protection Agency is required to register a pesticide upon finding that its composition is such as to warrant the proposed claims for the pesticide, its labeling complies with the Act, and it will perform its function without substantial adverse effects on the environment. The procedure for registration requires the applicant to file information with the Administrator, including the formula of the pesticide and a full description of tests made and their results if requested by the Administor. Congressman Kastenmeier objects to the provision limiting the use of tests or the disclosure of tests without permission of an applicant in subsequent applications for registration of other pesticides. He is quite correct in asserting that this limitation is a substantial change from the previous Act, see 7 U.S.C. § 135b (a) (4). Congressman Kastenmeier believes that vesting power in an applicant to withdraw test data from use in support of other applications would operate to perpetuate patent protection beyond 17 years. I do not believe that the bill does his, strictly speaking, but it does erect an unnecessary barrier to entry, whether a pesticide is patented or not, by imposing unnecessary testing costs upon subsequent applicants. In his discussion of the issue in the Congressional Record of November 9, 1971 (H. 10767), Congressman Kastenmeir suggests that the basic function of the patent law is to reward inventors for their ingenuity. This is not the case. Courts have long held that the basic function of the patent law is to promote science and arts by obtaining full disclosure of useful, novel, and inventive new ideas. The inventors' reward is secondary, and is allowed only insofar as it promotes the primary goal of the patent system-full disclosure of valuable new ideas. Consequently, when one applies for a patent, he is required to make a full disclosure of all elements, prior art, and so on dealing with the subject to be patented. Consequently, it would not be correct to say that Section 3 (c) (1) (D) perpetuates patent protection beyond 17 years since anyone can copy and produce the patented idea upon the expiration of the 17 year period. What the section does do, however, is to erect an unnecessary and artificial barrier to subsequent applicants who may be copying the patented or unpatented idea, by imposing test costs upon them. Moreover, the section vests power in the applicant to determine whether those costs shall be imposed. Thus, in a sense, the statute is creating a knd of exclusive right in applicants to the test data they have submitted in support of an application, even though the test data may not be patentable or subject to trade secret protection under existing law. The supporters of the provision claim that an applicant is entitled to protect his investment in tests and test results and "prevent the pirating" of this kind of information. That argument is totally specious. The present Act, 7 U.S.C. § 135b (1) (4), contains no right in the applicant to require the Administrator to keep test data secret and to not use that data in support of subsequent applications. 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 efficiently; 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. Finally, in a sense it does create an exclusive domain of property rights in the test data that is inconsistent with the basic theory of our patent and copyright laws. In shorthand fashion: if it is not patentable, it is not protectable. This Act would clearly make the test data protectable from use by competitors and the Administrator even though it is not patentable or copyrightable and it is information developed for an important public purpose. One phase of competition is fredom to copy and we have only withdrawn that basic economic right in certain limited circumstances where some greater public good is sought. In this case, I can see no greater public good that is being served by allowing a successful applicant for a pesticide registration to be able to erect unnecessary barriers to subsequent registrations, efficient administration of the law by the Administrator, and the public benefit of a full utilization of resources devoted to test data. In this sense Congressman Kastenmeier is correct in that some kind of quasi-property right in the sense of a right to exclude others from information is created by subsection (D). It does not rise to the level of patent protection like the ill-fated Plant Variety Protection Act, S. 3070, which passed the last Congress over the strong objections of a lone staff member situated deep in the bowels of the Antitrust Subcommittee. On that occasion, the bill granted 17 years of protection in the form of a certificate giving a person who developed new seed varieties sexually the right to exclude others from copying the sexually reproduced plant varieties. As I recall, on that occasion, I suggested that: "A rose may not be a rose when it is changed by sexual or asexual plant research, but a patent is still a patent even though its name is changed by routing the proposal through another committee." This case does not give the applicant a right to exclude others in an affirmative legal sense from the data submitted, but it does give the applicant a right to control the use made by the Adminstrator of the data submitted. In that sense, it creates a right in a property sense in an applicant and could be called some kind of patent right. Consequently, I would suggest that sub-section (D) be changed back to the present language found in the Federal Insecticide Act: if requested by the [Administrator], a full description of the tests made and the results thereof upon which the claims are based." Consequently, I would simply strike the language beginning with except" on the ground that there is no justification for imposing this entry barrier upon applicants and that it will be unduly restrictive on competition efficent administration of the Act. Although I have not had a full opportunity to study the bill, principally because of the pressure of my class schedule, I would suggest that you seriously consider proposing an amendment to Section 3(c) (5), the section which states when the Administrator shall register a pesticide. The Administrator is required to register a pesticide if he determines that... (C) it will perform its intended function without substantial adverse effects on the environment." This requirement places the burden upon the Administrator to measure adverse environmental effects of pesticides. In my opinion, the burden should be the other way. If it were, we would not be faced with the problem of producers of pesticides simply marketing their product without any concern for the environment, the efficacy of the product and its long range value to society. Given the level of funding for this type of program and the large number of pesticides that will probably be registered, it is my guess that we will not see the Administrator able to make a finding of substantial adverse effects on the environment or even seriously attempt to make such a study. The F.D.A. experience will be repeated. Consequently, I would amend Section 3(c) (5) (C) on page 19, in line 10, to read as follows: (C) The applicant for registration has demonstrated it will perform its intended function without substantial adverse effects on the environment." Given the definition of substantial adverse effects on the environment, Section 2(bb), page 15, line 24, I do not think the burden will be an exceptionally heavy one. In fact, it will be about as difficult a burden as the Administrator may wish to make it. Given the ecological dangers of pesticides, it does not seem unreasonable to require those who engage in profiting by the manufacture and sale of such products to insure to a limited degree that the product will perform its function without substantial adverse effects on the environment. In fact, the common law of negligence and warranty already imposes such a burden upon the manufacture of a product and it is about time we started to minimize the general damage done by preventing such products from getting on the market rather than trying to pick up the pieces after the damage is done through tort litigation. I hope this letter is of assistance in evaluating Congressman Kastenmeir's letter. I think his objection is an important one even though it somewhat misses the mark. Although the section does not extend patent protection in a literal sense, it has the potential for extending the effective monopoly granted by the patent because it places in the hands of a registered pesticide producer-patented or unpatented-the power to force the Administrator to make subsequent applicants pay the cost of testing. If I may be of further assistance, please do not hesitate to write. Chairman, Subcommittee on Research and General Legislation, Committee on Agriculture and Forestry, U.S. Senate, Washington, D.C. DEAR MR. CHAIRMAN: I am grateful that you took the opportunity earlier this month to hear the testimony of several organizations representing farmworkers affected by the use of agricultural chemicals. I am hopeful that their statements will be useful to your Subcommittee as you proceed to markup the H.R. 10729 amendments to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The hearing record of the Migratory Labor Subcommittee contains substantial and compelling evidence concerning the need to adequately protect farmworkers exposed to agricutlural chemicals. On March 8, I introduced in the Senate several amendments to H.R. 10729, and I am enclosing a copy of those amendments, together with explanatory information, as they appeared in the Congressional Record. I would be most appreciative if this material could be printed in your Subcommittee's hearing record on H.R. 10729, and I am hopeful that the amendments will receive due consideration as your Subcommittee proceeds with deliberations on this important legislation. Your attention to this matter will be greatly appreciated. Sincerely, ADLAI E. STEVENSON III, Chairman, Subcommittee on Migratory Labor. [Excerpt from the Congressional Record, Mar. 8, 1972] Mr. STEVENSON. Mr. President, the Senate Agriculture Committee is presently holding hearings on H.R. 10729. This is an important piece of legislation that, by changing the focus of the Federal Insecticide, Fungicide, and Rodenticide Act, could provide a more equitable and effective regulatory scheme for the control of the manufacture, distribution, and use of pesticides. As the committee deliberates on this legislation, I hope it will not overlook the effects on farmers and farmworkers that can accrue from the unscrupulous use of agricultural chemicals. Many such chemicals are harmful not only to the environment but also hazardous to man and particularly to those who are most closely associated with farming. The Migratory Labor Subcommittee, which I now chair, conducted 3 days of hearings during the 91st Congress on pesticides and the farmworker, which indicated the great need to protect farmers and farmworkers who are subjected to the unseen perils of toxic chemicals, gases, and airborne particulates. Special attention must be paid to providing explicit statutory protection of the farm and rural community faced with these hidden dangers. These citizens number in the millions, and include, among others, the self-employed family farmers as well as migrant and seasonal farmworkers. Injury and fatality figures are very high. An expert from the Department of Health, Education, and Welfare estimated that, during subcommittee hearings in 1970, possibly as many as 800 workers were killed and over 80,000 were injured each year by the improper and unwise use of agricultural chemicals. To protect these citizens living and working in rural America, I today propose an amendment to H.R. 10729, the bill now being considered by the Agriculture Committee. In this regard, the committee must be commended for taking the opportunity to hear witnesses from a broad and representative community of people concerned about the welfare of all those in rural America. Sections 1 and 3 of my amendment make it clear that a pesticide is misbranded within the meaning of section 2(q) (1) of the act if the directors or warnings do not adequately protect the health of farmers, farmworkers, and others who may come into contact with pesticides or pesticide residues. Section 3 provides that test data may be relied upon to support an application for registration under section 3(c) of the act only if the tests are conducted in accordance with applicable law and participation therein is based on a free, voluntary, and informed choice. Section 4 makes it clear that a pesticide shall be classified for restricted use if it might otherwise cause injury to farmers, farmworkers, or others who may come into contact with the pesticide or its residues. Section 5 makes it clear that certified applicators must be competent to take measures needed to protect the health of farmers, farmworkers, and others who may come into contact with pesticides or pesticide residues. Mr. President, I ask unanimous consent that the text of my amendment be printed at this point in the Record. (The being no objection, the amendment was ordered to be printed in the Record, as follows): AMENDMENT No. 1017 On page 11, line 16, change the semicolon to a comma and insert the following immediately thereafter: "including the protection of the health of farmers, farmworkers, and others who may come into contact with such pesticides or pesticide residues; or". On page 11, line 21, change the period to a comma and add the following immediately thereafter: "including the protection of the health of farmers, farmworkers, and others who may come into contact with such pesticides or pesticide residues.". On page 17, line 16, change the semicolon to a comma and add the following immediately thereafter: "Provided, That the Administrator shall not rely on test results submitted pursuant to this subsection unless he determines that (i) the tests were conducted in accordance with applicable federal, state, or local law, and (ii) participation in the tests was the result of a free, voluntary, and informed choice by each participant.". On page 21, insert the following immediately following line 9: "farmer, farmworker, or other person who may come into contact with the pesticide or pesticide residues.". On page 23, line 22, change the period to a comma and add the following immediately thereafter: "and such competence shall include the ability to undertake such measures as the Administrator may by regulation require to protect the health of farmers, farmworkers, and others who may come into contact with such pesticides or pesticide residues.". STATEMENT OF HON. BOB PACKWOOD, A UNITED STATES SENATOR FROM THE STATE OF OREGON Mr. Chairman, first of all I want to express my deep appreciation to you personally for holding these additional hearings on pesticide legislation. As you and I know, H.R. 10729, the House-passed bill, differs considerably from S. 745 the bill I introduced last year on behalf of the Administration, and which was co-sponsored by Senators Case, Scott, Javits and Gurney. Following House passage of H.R. 10729, many individuals and organizations xpressed to me their concern about and dissatisfaction with the provisions of the House bill. It is my understanding that my colleague, Senator Case, had a similar experience. In light of these developments, Senator Case and I joined in asking the Subcommittee Chairman to hold additional hearings on the House bill; thereby, allowing all parties to this controversy a chance to speak to the Senate Committee on H.R. 10720. It is my sincere hope in light of the Chairman's kind consideration in calling these hearings that a full record can be provided on pesticides for the Committee's use in developing legislation it will report for Senate action. Mr. Chairman, I do not wish to take up any more of the hearing time-time that could be better used by other witneses here today. I urge the Committee to give serious attention to what these witnesses have to say about H.R. 10729. Thank you, Mr. Chairman. U.S. SENATE, Washington, D.C., March 6, 1972. Senator JAMES B. ALLEN, Chairman, Subcommittee on Agricultural Research and General Legislation, Senate Agriculture Committee, New Senate Office Building, Washington, D.C. DEAR MR. CHAIRMAN: Thank you for scheduling additional hearings on H.R. 10729, the House-passed pesticide control bill. While I will be unable to appear personally at the hearings scheduled for March 7 and 8, I want to express my appreciation for your consideration in giving concerned environmental organizations the opportunity to be heard on the considerable differences between H.R. 10729 and S. 745, the bill introduced in the Senate on behalf of the Administration. I would appreciate it if this letter could be made part of the record. CLIFFORD P. CASE, U.S. Senator. Senator JAMES B. ALLEN, COMMONWEALTH OF PENNSYLVANIA, Chairman, Subcommittee on Agriculture Research and General Legislation, U.S. Senate, Washington, D.C. DEAR SENATOR ALLEN: As Secretary of Agriculture for the Commonwealth of Pennsylvania there are several points I should like to have entered in the testimony for the hearing on HR 10729-"Federal Environmental Pesticide Control Act". It appears that if the "Act" is to an effective instrument in helping to improve the quality of living for all Americans while recognizing the basic needs of a modern and efficient agricultural industry in this nation, there must be cooperation, support, and involvement of the states. We in Pennsylvania want to be in a position to do our part in making this possible. However, for this to happen there are several things about HR 10729 which I believe need to be made very clear, and there are some things which we believe are not desirable. In the final drafting of HR 10729 in the Committee on Agriculture of the House of Representatives, it was recognized, at least in part, that to have a strong cooperative federal-state program of pesticide regulations, the program had to be jointly funded. I say "at least in part," because the provision for funding only applies to assisting state agencies. financially in the training and certification of pesticide applicators. I believe state agencies must be given financial assistance in developing and administrating the entire state program rather than only providing assistance for training and certification of pesticide applicators. Furthermore, I believe this funding should be on a basis of eighty percent federal and twenty percent state funds. It is my understanding that your committee proposed a revision to Section 24 (c) that would greatly improve federal-state cooperation regarding registration of intra-state products. I believe it is most important that you adopt this recommendation of your staff. I trust there will be sufficint flexibility in the provisions under Section 4 to establish restrictions which are suited to the degree of hazard and adverse environmental effects that could be caused by misuse of the pesticide when determining how a private applicator is to be certified to use a Restricted Use pesticide. What I am saying is-let us not develop a massive "paper-shuffling" program by requiring every farmer to be licensed who applies pesticides only to his own farm or land he leases for his own use. Make the program flexible enough to meet the requirements for certification of a private applicator, by, for instance, simply signing of a pesticide register certifying the farmer has read the instructions and will apply the pesticide in accordance with such instructions. Another important aspect in implementation of H.R. 10729 will be the selection of the pesticides that will be placed on the restricted use list. A recommendation from the Association of American Pesticide Control officials should certainly be heeded which states "restricted use pesticides should be limited to pesticides of national significance which have had a historic pattern of hazard to the user because of acute dermal or inhalation toxicity or which have caused substantial 76-194-72- -25 |