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the record. Now, as to the amendments, I believe you are suggesting that the amendments recommended by Mr. Dominick of EPA, that they be adopted?

Mr. JOHNSON. Mr. Chairman, I see nothing about his suggestions yesterday that would be derogatory to the interests of our members. We have been well pleased with the attitude that EPA administrators have had toward farming generally. It is one of the few agencies of Government that ever come over and ask our opinion about what they are doing. I commend them for that.

Senator ALLEN. You haven't seen any indication that they are trying to get a weak bill approved, have you?

Mr. JOHNSON. Mr. Chairman, I would say no. I think that what they are trying to do is to get a reasonable balance between what would afford consumers adequate protection and still permit farmers the right to use pesticides they need to produce this Nation's food requirement.

Senator ALLEN. I notice your suggestion about the deletion of certain language which would have the effect of requiring the applicant to submit data with regard to the product sought to be registered along with his application. Do you think that that would be sound or fair to the application to disclose the results of his research and the formula that he may have devised. Do you think that ought to be made a matter of public information?

Mr. JOHNSON. Mr. Chairman, as I indicated, patents on most of these pesticides, 90 percent of them, run for 17 years. They protect the original manufacturer for 17 years. Now, this legislation, at the end of that patent expiration period, would deny another company who wanted to come in and market a pesticide of the type on which the patent had expired. It would make it necessary to go through the long period it took originally for the company getting supportive data that would be necessary to register the pesticide. We believe that this language in the bill extends patent protection even though the patent period had expired. Therefore, if in the first place the material is already on file in regard to the pesticide at the end of his patent period, why make a competing company come in and duplicate it?

Senator ALLEN. You think that the company seeking to register a product should then be able to state in his application that this chemical is all right; look at the company A's application and that proves that our product is already right.

That would be your judgment of this?

Mr. JOHNSON. I can only go by the advice I have gotten from our people in the country that deal with pesticides. We don't seek to deny patent rights to any company on a pesticide it has developed. All we seek is not to duplicate supporting data to register such a product when the patent has expired.

Senator ALLEN. Leaving patents aside, that is not the usual case that an applicant would have a competitor seeking to register a competitive product. Where this would arise most of the time is where an applicant would come in with an unpatented product and he would be required, if you delete this language, to give the disclosure of the formula and of the research prior to the registration of this product. Mr. JOHNSON. Mr. Chairman, you raise a point that perhaps has some application here. However, for the very limited number of pes

ticides that are not being patented-about 10 percent I am sure that the deletion of this language would then dictate that any pesticide brought to the agency as a new pesticide would be patented and perhaps should be. I don't see anything wrong with a company protecting its rights.

Senator ALLEN. You would feel that it ought to have to make disclosure with regard to a new formula?

Mr. JOHNSON. Well, he has the protection of the patent.

Senator ALLEN. Not necessarily. Does the patent always precede the application for registration?

Mr. JOHNSON. I think it perhaps does. We have a new bill. I don't know what to speculate but I would assume under the terms of this bill, especially if this language was deleted, the patent would assuredly precede any application for registration. But I don't think that works any undue hardship on a chemical manufacturer.

Senator ALLEN. Would it discourage research and development by chemical companies if they are required to make a full disclosure to the public in general?

Mr. JOHNSON. As long as they have the right to patent the process they developed through which they are marketing a new chemical, I do not think it would in any way prevent research and development. Senator ALLEN. I see. Thank you very much.

Mr. JOHNSON. Thank you, Mr. Chairman.

(Mr. Johnson's prepared statement is as follows:)

Mr. Chairman and members of the subcommittee, National Farmers Union has just ended a convention, February 28-March 2, in Houston, Texas. The delegates to the convention 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 Subcommittee by the Environmental Protection Agency witness, David D. Dominick, to be constructive. We view other changes in HR 10729, recommended by Mr. Dominick, also to be constructive and helpful.

In this connection there is one amendment he suggested 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 is found on Page 19, Line 7, of the Senate Agriculture Committee Print, after the comma. The language that we recommend be deleted from the bill is as follows: 66 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."

This objectionable language in the Committee Print begins on Page 19, in the middle of Line 7 and extends through Line 11.

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.

Thank you very much, Mr. Chairman, for the time to present the views of National Farmers Union. We will be happy to submit to any questions that the Subcommittee might have.

STATEMENT OF EDWARD K. HERTEL, VICE PRESIDENT, FMC CORP., MIDDLEPORT, N.Y., AND CHAIRMAN OF THE BOARD, NATIONAL AGRICULTURAL CHEMICALS ASSOCIATION

Senator ALLEN. Mr. Hertel, you may proceed.

Mr. HERTEL. Thank you, Mr. Chairman. I am testifying today as chairman of the board of directors of the National Agricultural Chemicals Association. The national, our association, membership includes 113 basic manufacturers, formulators, and associated suppliers of the agricultural pesticide industry. I am vice president of FMC Corp. and the division manager of Niagara Chemical Division of FMC Corp., Middleport, N.Y.

We are a manufacturer of basic and formulated pesticides. I have with me Mr. Parke Brinkley, president of our national association.

Mr. Carlos Kampmeier, Rohm & Haas Co., Philadelphia, Pa., past chairman of our board of directors, and Mr. John Conner, our association counsel. Although I am going to look at my statement here, I am going to skip through this rather rapidly and try to hit the bright spots of it. The National Agricultural Chemicals Association has supported the objectives of the proposed legislation; that is, to protect the public health and welfare and the environment by a comphehensive regulation of pesticides.

As was stated by Dr. R. H. Wellman, past chairman of the board of this association, during the House proceeding and I quote:

Our industry understands and supports the needs of the Administrator of EPA to have the legal power and the machinery to protect man and his environment because we are people and this is our environment too. As a result we as an industry will support adequate regulation of pesticides to meet these requirements.

The pesticide industry throughout the consideration of H.R. 10729 and its predecessor bill in the House has supported improved and workable regulation of pesticides. At the end of the consideration of H.R. 10729 by the House Committee on Agriculture and passage by the Houe of Representatives, the industry believed that all major issues had been brought forward and had been given fair consideration. Although the bill as enacted by the House contained much with which we disagreed and omitted numerous provisions which we believe should have been included, the industry recognized that the House had given the bill prolonged consideration and had achieved its objective of reasoned progress. Accordingly, our association supported the enactment of the bill in the House.

We still consider the bill generally to be fair and equitable. There are, however, a number of amendments which we propose for consideration by this subcommittee. These amendments are attached to this statement designated as amendments 1, 2, and 3, which we propose for consideration by your committee. We believe our amendment designated in our testimony as amendment 1, to be the most important. The amendment covers the right of third-party participation.

After passage of H.R. 10729 by the House, the Environmental Protection Agency on January 22, 1972, published proposed "Rules of Practice" to be issued under the present Federal Insecticide, Fungicide, and Rodenticide Act. In his testimony before the subcommittee yesterday, Mr. David D. Dominick, Assistant Administrator, Environmental Protection Agency, said with reference to these proposed rules:

One additional point of comparison: We believe the the House Bill carries forward the policy of open administration of our regulatory system provided for by FIFRA as interpreted by the courts, the Administration's bill S. 745 and our recently proposed rules of practice. We do not believe that the language in the House Bill is intended to close the door to responsible citizens, user groups or State or Federal agencies seeking to participate in and thereby assist in improving our regulatory decision. These groups have standing. We are promulgating new rules to reflect this approach which are intended to permit an interested or affected person or group to seek review of a registration upon a showing that there is new evidence bearing on the registration or that the registration is inconsistent with present agency policy and the chemical in question is a significant problem.

These requirements will prevent nuisance complaints and avoid disrupting agency priorities. They will prevent the chemical industry from having its registrations irresponsibly attacked. These rules will also insure that the ad

ministraton of FIFRA will be kept in the first instance in EPA subject to Court of Appeals review after a record has been created so the judiciary can see the full picture.

The publication and proposed issuance of these rules raises a matter of substantial signifiance in the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act. We do not quarrel with the objective of the rules as stated by Mr. Dominick to prevent nuisance complaints having the pesticide registrations of our industry irresponsibly attacked and keeping the administration of FIFRA in the first instance in the Environmental Protection Agency. We endorse these objectives.

Our amendment No. 1 would state as a statutory principle that registration of a pesticide by the Administrator should be prima facie evidence that its labeling and packaging comply with the provisions of the act.

Certainly our amendment would provide a procedure under which third parties could petition for the cancellation of a pesticide. We believe it would be reasonable to require that the petition should be accompanied by scientific data which was not available to the Administrator when the product was registered and must not present merely data of arguments which are redundant or which have been presented previously and, two, any opinions which are expressed in the petition or accompanying data should set forth the data on which the opinions are based and third, and allegations as to the safety or lack of safety should be stated in terms of whether the safety or lack of safety exists when the pesticide is used as directed and with the cautions commensurate with the label warning.

The third portion of our amendments would require the Administrator to review petitions and accompanying data, and within a period of 120 days, make determination of whether a notice of intention to cancel should be issued.

The fourth part of amendment No. 1 would provide that the petitioner would be given the right to obtain judicial review of the Administrator's decision by instituting an argument in the U.S. district court to determine whether the decision of the Administrator to issue the cancellation notice constitutes action which is arbitrary, capricious, or an abuse of discretion.

In summary, our amendment No. 1 provides an orderly procedure in which third parties can petition for the cancellation of pesticide registrations with assurance that their petition and accompanying data will be reviewed and acted upon by the Administrator within a reasonable period of time. Further, it accords to them the right of judicial review if the Administrator determines that their petition and data does not warrant the issuance of an intention to cancel.

Our second amendment related to disclosure of data submitted in support of the registration which may be classified as trade secrets. Our third amendment relates to the manner in which a product registered for general and restricted use should be labelled and packaged.

The next portion of our statement deals with section 3 (c) (2) (d) of H.R. 10729, which provides 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.

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