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The Pesticide Formulators Association was organized subsequent to the hearings held last fall by this Committee on H.R. 8841, a bill to extend and to amend the Federal Insecticide, Fungicide, and Rodenticide Act. Our members represent a wide range of formulated pesticide products including but not limited to agricultural, veterinary, home and garden, household and structural pest control.

Today, we are pleased to appear for the first time before this committee to expresss our views on H.R. 12944, a bill to extend appropriations for FIFRA for a period ending September 30, 1977.

We understand the technical nature of the amendment provided in H.R. 12944. Our reason for testifying is to express a very deep concern that the extended appropriations may offer an opportunity for further delaying oversight hearings which under the current appropriation would be scheduled prior to April 1, 1977.

By extending appropriations until September 30, 1977, oversight bearings may well be extended to late spring or the summer months. More importantly, we are testifying to respectfully request of the committee that limited oversight hearings be held as soon as reasonably and practicably possible to review and institute, where necessary, appropriate legislative changes to section 3 of FIFRA and particularly to the complex issues embodied in section 3 (c) (1) (D) relative to data compensation. This request would be consistent with remarks that Chairman Foley represented during House Floor debate on H.R. 8841 on October 3, 1975.

As recognized by Mr. Foley, "The issue of data compensation is a very complex issue." And we further recognized that "a number of questions (were) brought to the committee's attention for the first time after the committee had largely completed its consideration of H.R. 8841, as amended."

Mr. Foley then continued to state that he was "writing a letter to Mr. Train, Administrator of EPA, asking him to make a detailed study regarding administration of this section and submit to the committee as expeditiously as possible recommendations of any changes in legislation that he may deem desirable. Some of the questions at issue (would) be given serious consideration by the committee certainly in connection with renewal of funding authorizing of FIFRA next year if not at an earlier date."

It is our understanding, Mr. Poage, that that letter was not submitted to the Administrator, and there has been no further consideration by the committee on this matter.

We recognize that Mr. Foley's comments on the House floor debate were prior to amendments subsequently made to section 3 (c) (1) (D). Even with those amendments, formulators are encountering tremendous difficulties with the implementation of section 3(c) (1) (D) that the need for the study and committee review continues to be extremely important to us now.

Equally as important and serious, we wish to make the committee aware that procedures, interpretations and policies adopted by the EPA immediately prior to or subsequent to the 1975 amendments to FIFRA have brought the process of registering pesticides for formulators to a virtual halt.

Since July 1975 our members, and perhaps all formulators, have been unable to obtain a single pesticide registration since EPA published regulations and instituted other procedures for registering pesticides.

The problems now associated with registering pesticides are in large part due to the data compensation provisions or section 3 (c) (1) (D) of FIFRA.

The major registration problems facing formulators are more fully explained in a recent address by our past association president, Mr. Bobby Pace, a copy of which we have for the committee.1 These problems, without going into detail, involve: (1) the method of supporting applications, (2) data gaps which create double standards for registering pesticides, and (3) procedures for reregistering pesticides.

These obstacles and EPA's failure to implement any regulations on determining reasonable compensation are very serious matters and we cannot overemphasize their impact.

Pesticides must be registered in order to be sold in the United States. For our members to be unable now, and possibly for another year or longer, to obtain new or amended registrations and to jeopardize reregistration of currently registered pesticides presents an intolerable situation. We urgently need legislative relief in order to continue to remain in business and to serve consumers and farmers for needed pest control.

Our members now are making decisions to discontinue registrations and not to seek new registrations or new uses even if new products or uses would be safer for man or the environment. Formulators will discontinue and not seek registration for specialty uses or for special local needs.

To the extent that complete oversight hearings would not be delayed and that the matter of data compensation and registration delays be given immediate committee attention, we do not object to H.R. 12944.

Finally, Mr. Chairman, in light of the short notice of this hearing, we request the opportunity to more fully express our views in a written statement to be furnished within a day or two.

Mr. POAGE. Without objection, it will be done.

[The following statement was subsequenty submitted:]

1 Held in committee file.

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The Pesticide Formulators Association respectfully submits the following information to supplement its testimony of April 6, 1976 regarding II.R. 12944, a bill to extend appropriations for the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). We respectfully request that these comments be included in the record of the Committee's hearing on this bill.

Our purpose in testifying was not to request or to expect
oversight hearings on FIFRA before passage of H.R. 12944.
It was our intent, however, to alert the Committee to some
very serious problems regarding registration delays and
data compensation that need immediate resolution. For our
members formulating for agricultural uses, the oversight
hearings scheduled for the Committee during the Spring
of 1977 will not alleviate these problems in order for
formulators to meet the 1977 growing season.

Our point concerning registration delays could not be better illustrated than in the EPA response of April 16, 1976 to the Committee which show that only 14 pesticides have been registered during the past 9 months. We urge the Committee to look at EPA's list (attached as Appendix A) to note:

(1) The list includes pesticides with new active ingredients as well as pesticides already registered for other uses or for uses already registered to others.

(2) Eight (8) registrations involve the same product issued to different registrants.

(3)

No registrations for a pesticide in major use today is being issued to new applicants, although the identical pesticide is currently registered

for others.

We find EPA's performance in registering pesticides under
the amended FINRA as appalling, especially since the workload
of the Agency in the immediate past involved reviewing
approximately 15,000 applications per year.

In addition to our statement before the Committee on April 6, 1976, those members of our Association who consider themselves as "small business" fear extinction because recent test requirements established by the EPA are staggering or prohibitive for small formulators. We honestly do not believe the Agency's insatiable demands for data are necessary for each product. We support many of the data requirements necessary to establish the safety and efficacy of a pesticide. In many cases, we believe that scientific extrapolation for existing data should be adequate for many formulated products. Dollar volume potential per product may not be sufficient to interest larger producers to supply or provide research for a given needed market such as for spevialty or minor uses. This is a need fulfilled by formulators.

Another matter which deserves attention relates to trade
secrets. At the present time, one can effectively prevent
use of one's data to support another's application by
declaring the data as conficential or trade secret regardless
of the validity of confidential claim. Although EPA is
pursuing a policy that safety and efficacy data cannot
qualify generically for confidential treatment, the Agency
is holding up for a considerable length of time many appli-
cations for registration without acting to determine
whether data intended to be referenced or used, in fact,
constitutes a trade secret or should otherwise be afforded
confidential treatment.

We expand upon our previous testimony by submitting three letters sent to EPA which identify the problems now facing our members and asking for specific relief. These letters provide our analysis of the following problems:

(1)

(2)

(3)

Data referencing (Appendix B)

Data gaps which create double standards (Appendix C)

Comments on current and proposed policies with
respect to data compensation [Section 3 (c) (1) (D)
of FIFRA]. (Appendix D)

We appreciate your consideration of our views and offer the assistance of the Association and its members to resolve the issues presently raised, or in the future, as the Committee exercises its oversight responsibilities for the FIFRA.

We would especially welcome the opportunity to work with the Committee Staff in an attempt to resolve our present dilemma and to reserve until a later date the determination of whether oversight hearings are needed at an earlier date than presently scheduled.

RTA/jmh

Enclosures (4)

Respectfully submitted,

PESTICIDE FORMULATORS ASSOCIATION

Robert Alikonin

Robert J. Alikonis
Executive Secretary and -

General Counsel

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